prem14a
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
(Rule 14a-101)
INFORMATION REQUIRED IN PROXY STATEMENT
SCHEDULE 14A INFORMATION
Proxy Statement Pursuant to Section 14(a) of the
Securities
Exchange Act of 1934 (Amendment
No. )
Filed by the Registrant þ
Filed by a Party other than the
Registrant o
Check the appropriate box:
þ Preliminary
Proxy Statement
o Confidential,
for Use of the Commission Only (as permitted by
Rule 14a-6(e)(2))
o Definitive Proxy
Statement
o Definitive
Additional Materials
o Soliciting
Material Pursuant to
§240.14a-12
NxSTAGE MEDICAL, INC.
(Name of Registrant as Specified In
Its Charter)
(Name of Person(s) Filing Proxy
Statement, if other than the Registrant)
Payment of Filing Fee (Check the appropriate box):
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o
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No fee required.
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þ
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Fee computed on table below per Exchange Act
Rules 14a-6(i)(1)
and 0-11.
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(1)
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Title of each class of securities to which transaction applies:
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Common stock, par value $0.001, of NxStage Medical, Inc
(NxStage common stock)
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(2)
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Aggregate number of securities to which transaction applies:
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6,500,000 shares of NxStage common stock
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(3)
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Per unit price or other underlying value of transaction computed
pursuant to Exchange Act
Rule 0-11
(set forth the amount on which the filing fee is calculated and
state how it was determined):
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The filing fee was determined on the basis of a maximum
consideration equal to 6,500,000 shares of NxStage common
stock at $13.79, which is the average of the high and low prices
per share of NxStage common stock on August 23, 2007, as
reported on The Nasdaq Global Market. In accordance with
Section 14(g) of the Securities Exchange Act of 1934, as
amended, the filing fee was determined by multiplying 0.00003070
by the value set forth in the preceding sentence.
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(4)
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Proposed maximum aggregate value of transaction:
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$89,635,000
$2,752
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Fee paid previously with preliminary materials.
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Check box if any part of the fee is offset as provided by
Exchange Act
Rule 0-11(a)(2)
and identify the filing for which the offsetting fee was paid
previously. Identify the previous filing by registration
statement number, or the Form or Schedule and the date of its
filing.
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(1)
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Amount Previously Paid:
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(2)
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Form, Schedule or Registration Statement No.:
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SUBJECT
TO COMPLETION, DATED AUGUST 29, 2007
PROXY
STATEMENT
439 South Union St., 5th Floor
Lawrence, Massachusetts 08143
NxStage Medical, Inc. and David S. Utterberg have entered into a
stock purchase agreement under which we will purchase from
Mr. Utterberg the issued and outstanding shares of
Medisystems Corporation and Medisystems Services Corporation,
90% of the issued and outstanding shares of Medisystems Europe
S.p.A. (the remaining equity of which is held by Medisystems
Corporation) and 0.273% of the issued and outstanding equity
participation of Medisystems Mexico s. de R.L. de C.V. (the
remaining equity of which is held by Medisystems Corporation),
which are collectively referred to as the MDS Entities. Our
acquisition of the MDS Entities is referred to as the Stock
Purchase. Following the Stock Purchase, each of the MDS Entities
will be a direct or indirect wholly-owned subsidiary of ours.
We will issue Mr. Utterberg 6,500,000 shares of our
common stock, subject to a post-closing working capital
adjustment that may increase or decrease the number of shares of
common stock we issue to Mr. Utterberg, in consideration
for the Stock Purchase. The shares of our common stock issuable
to Mr. Utterberg pursuant to this proxy statement are
referred to as the Shares. In addition, we may be required to
issue additional shares of our common stock to
Mr. Utterberg. Pursuant to the terms of the Stock Purchase,
we and Mr. Utterberg have agreed to indemnify each other in
the event of certain breaches or failures, and any such
indemnification amounts must be paid in shares of our common
stock, valued at the time of payment. However, we will not be
required to issue shares for indemnification purposes that in
the aggregate would exceed 20% of the then outstanding shares of
our common stock without first obtaining stockholder approval,
and any such shares will not be registered under the Securities
Act of 1933, as amended.
Our shares of common stock are listed on the NASDAQ Global
Market under the symbol NXTM. As
of ,
2007, the last trading day before the date of this proxy
statement, the last sales price of our common stock, as quoted
on the NASDAQ Global Market, was $ .
This proxy statement has been prepared in connection with a
special meeting of our stockholders to be held at the offices of
WilmerHale, 60 State Street, Boston, Massachusetts 02109,
on ,
2007 at a.m., local time. At the special
meeting, stockholders will consider a proposal to approve the
issuance of the Shares and a proposal to amend our 2005 Stock
Incentive Plan to increase the number of shares of our common
stock that may be issued under the plan. Pursuant to applicable
NASDAQ Marketplace Rules, the issuance of the shares of our
common stock pursuant to the Stock Purchase and the amendment to
our 2005 Stock Incentive Plan require approval by holders of a
majority of the shares of our common stock present and voting at
a special meeting of stockholders at which a quorum is present.
This proxy statement sets forth more information about NxStage,
Mr. Utterberg, the MDS Entities, the Stock Purchase and the
proposed amendment to our 2005 Stock Incentive Plan. We
encourage you to read carefully this proxy statement before
voting, including the section entitled Risk Factors
beginning on page 18.
Sincerely,
Winifred L. Swan, Secretary
This document is
dated ,
2007, and is first being mailed to our stockholders on or
about ,
2007.
NxSTAGE
MEDICAL, INC.
439 South Union St., 5th
Floor
Lawrence, Massachusetts
08193
NOTICE OF SPECIAL MEETING OF
STOCKHOLDERS
To the stockholders of NxStage Medical, Inc.:
A special meeting of our stockholders will be held at the
offices of WilmerHale, 60 State Street, Boston, Massachusetts
02109,
on ,
2007 at a.m., local time. At the
special meeting, stockholders will consider and act upon the
following matters:
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the issuance of 6,500,000 shares of our common stock, plus
any additional shares of common stock issuable pursuant to a
post-closing adjustment, to David S. Utterberg pursuant to the
stock purchase agreement, dated as of June 4, 2007, between
Mr. Utterberg and NxStage, as amended (which is referred to
in this notice and proxy statement as the stock purchase
agreement), and any additional shares of our common stock that
we may be required to issue Mr. Utterberg in the future to
satisfy any indemnification claims payable by us for failures or
breaches under the stock purchase agreement and/or the
consulting agreement we intend to enter into with
Mr. Utterberg; and
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an amendment to our 2005 Stock Incentive Plan, or 2005 Plan, to
increase the number of shares of our common stock that may be
issued under the 2005 Plan by an additional 3,800,000 shares, of
which no more than 1,500,000 shares shall be granted as
restricted stock.
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Pursuant to applicable NASDAQ Marketplace Rules, the issuance of
shares of our common stock pursuant to the stock purchase
agreement and the amendment to our 2005 Plan require approval by
holders of a majority of the our shares of common stock present
and voting at a special meeting of stockholders at which a
quorum is present.
After careful consideration, our board of directors has
approved the proposals referred to above and concluded that they
are fair to, and in the best interests of, NxStage and our
stockholders. Our board of directors recommends that our
stockholders vote FOR each of the proposals referred
to above.
You are entitled to vote only if you were a holder of our common
stock at the close of business
on ,
2007, the record date for the special meeting. Only record
holders of our common stock at the close of business on that
date are entitled to notice of and to vote at the special
meeting and at any adjournments or postponements thereof. At the
close of business on the record date, there
were shares
of our common stock outstanding and entitled to vote.
The proxy statement accompanying this notice sets forth more
information about NxStage, Mr. Utterberg, the stock
purchase agreement and related transactions and the proposed
amendment to our 2005 Plan. The accompanying materials also
provide instructions on how to vote your shares in person at the
special meeting or by proxy.
Your vote is very important. Whether or not you plan to attend
the special meeting, please take the time to vote by completing
and mailing the enclosed proxy card to NxStage or, if the option
is available to you, by granting your proxy electronically over
the Internet or by telephone. If your shares are held in
street name, meaning they are held for your account
by a broker or other nominee, your shares will only be voted at
the special meeting if you direct your broker to vote your
shares by following the procedures established by your broker.
By order of the board of directors,
Winifred L. Swan, Secretary
,
2007
Lawrence, Massachusetts
TABLE OF
CONTENTS
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iii
The following questions and answers briefly address some
commonly asked questions about the special meeting and this
proxy statement. They may not include all the information that
is important to you. You should read carefully this entire proxy
statement, including the annexes and the other documents
referred to herein.
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Q: |
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What will happen in connection with the Stock Purchase? |
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We are proposing to purchase from David S. Utterberg, who is a
member of our board of directors and the owner of approximately
6.7% of our common stock: |
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all of the issued and outstanding shares of
Medisystems Corporation, or MDS;
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all of the issued and outstanding shares of
Medisystems Services Corporation, or MDS Services;
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90% of the issued and outstanding shares of
Medisystems Europe S.p.A. (the remaining equity of which is held
by MDS), or MDS Italy; and
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0.273% of the issued and outstanding equity
participation of Medisystems Mexico s. de R.L. de C.V. (the
remaining equity of which is held by MDS), or MDS Mexico.
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MDS, MDS Services, MDS Italy and MDS Mexico are referred to
collectively in this proxy statement as the MDS Entities. We
refer to our acquisition of the MDS Entities under the stock
purchase agreement as the Stock Purchase. |
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As consideration for the Stock Purchase, we will issue
Mr. Utterberg 6,500,000 shares of our common stock,
plus any additional shares issuable pursuant to a post-closing
working capital adjustment provided for in the stock purchase
agreement. We may also be required to issue Mr. Utterberg
additional shares of our common stock, which we refer to as the
indemnification shares, to satisfy any indemnification claims
payable by us under the stock purchase agreement
and/or the
consulting agreement we intend to enter into with
Mr. Utterberg, which is described below. In this proxy
statement, we refer to the shares to be issued to
Mr. Utterberg as consideration for the Stock Purchase,
together with the indemnification shares, as the Stock Purchase
Shares. |
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Following the Stock Purchase, each of the MDS Entities will be a
direct or indirect wholly-owned subsidiary of ours. A copy of
the stock purchase agreement is attached to this proxy statement
as Annex A. |
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Why are you receiving this proxy statement? |
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Our stock is listed on the NASDAQ Global Market.
Rule 4350(i) of the NASDAQ Marketplace Rules requires
listed companies to obtain stockholder approval in certain
circumstances, which include: |
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when an issuance or potential issuance of securities
would result in a change in control of the company, as such term
has been interpreted by NASDAQ for purposes of Rule 4350(i);
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when an equity compensation arrangement is made,
pursuant to which stock may be acquired by directors or
directors affiliates; and
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when in connection with the stock or assets of
another company, where due to the issuance of common stock or
securities convertible into common stock, the securities to be
issued represent 20% or more of the voting power or number of
shares of common stock outstanding before the issuance.
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You are being asked to approve the issuance of the Stock
Purchase Shares because such issuance implicates each of the
circumstances listed above, and, pursuant to the stock purchase
agreement, our stockholders approving the issuance of the Stock
Purchase Shares to Mr. Utterberg is a condition to closing
the Stock Purchase. In addition, we are proposing to amend our
2005 Stock Incentive Plan, or 2005 Plan, to increase the number
of shares reserved for issuance under the 2005 Plan by
3,800,000, from 3,601,459 to 7,401,459; provided that, of the
additional 3,800,000 shares, no more than
1,500,000 shares may be granted as restricted stock. Under
NASDAQ Marketplace Rule 4350(i) and the terms of the 2005
Plan, we are required to obtain stockholder approval prior to
amending the 2005 Plan to increase the number of |
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shares issuable under the 2005 Plan. We will hold a special
meeting of our stockholders to obtain approval of the issuance
of the Stock Purchase Shares and the amendment to our 2005 Plan.
This proxy statement contains important information about
NxStage, the special meeting, the Stock Purchase, the MDS
Entities, Mr. Utterberg and the proposed amendments to our
2005 Plan, and you should read it carefully. |
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Why is NxStage proposing the Stock Purchase? |
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We believe the Stock Purchase will provide the following
benefits: |
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expansion of our business on a commercial,
operational and financial scale; and
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enhancement of our capability to execute
operationally.
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We also believe that the Stock Purchase has the potential to
accelerate our profitability. For a description of the other
factors considered by our board of directors in determining to
approve the Stock Purchase, see The Stock
Purchase Our Reasons for the Stock
Purchase beginning on page 57. |
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Does NxStages board of directors recommend voting in
favor of the issuance of the Stock Purchase Shares and the
amendment to the 2005 Plan? |
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Proposal One Approval of the Issuance of the
Stock Purchase Shares |
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Yes. After careful consideration, our board of directors
determined that the Stock Purchase is fair to, and in the best
interests of, NxStage and our stockholders. Our board of
directors recommends that our stockholders vote
FOR the issuance of the Stock Purchase Shares. |
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For a description of the factors considered by our board of
directors in making its determination, see The Stock
Purchase Our Reasons for the Stock Purchase
beginning on page 57. |
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Proposal Two Approval of an Amendment to our
2005 Plan |
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Yes. After careful consideration, our board of directors
believes that the proposed amendment to our 2005 Plan is in the
best interests of NxStage and our stockholders and recommends a
vote FOR the approval of the amendment to our
2005 Plan. |
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For a description of the factors considered by our board of
directors in making its determination, see Matters
Submitted to a Vote of NxStage Stockholders
Proposal Two Approval of an Amendment to Our
2005 Plan beginning on page 49. |
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Is the Stock Purchase a related person transaction? |
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Yes. Mr. Utterberg is a director of NxStage and currently
owns approximately 6.7% of our outstanding common stock based on
the number of shares of our common stock outstanding as of
July 31, 2007. Pursuant to our policies and procedures
concerning related person transactions, the Audit Committee of
our board of directors reviewed and approved the Stock Purchase. |
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What will Mr. Utterberg receive as consideration for the
Stock Purchase? |
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Upon the closing of the Stock Purchase, we will issue
Mr. Utterberg 6,500,000 shares of our common stock.
The total number of shares payable by us to Mr. Utterberg
is subject to a post-closing working capital adjustment pursuant
to the stock purchase agreement that may increase or decrease
the final number of shares of common stock issued to
Mr. Utterberg. We will not know, until at least
60 days following the closing of the Stock Purchase, how
many shares, if any, we will be required to issue, or which Mr.
Utterberg will be required to return, in connection with the
post-closing working capital adjustment. One million of the
shares issued to Mr. Utterberg will be placed into escrow
to cover potential indemnification claims we may have against
him. For a further discussion of the consideration payable to
Mr. Utterberg, see The Stock Purchase
Stock Purchase Consideration on page 66 and for a
further discussion of the escrow arrangement and indemnification
see The Stock Purchase
Agreement Indemnification beginning on
page 74. |
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Could we be required to issue Mr. Utterberg additional
shares of our common stock in connection with the Stock
Purchase? |
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Yes. We may be required to issue Mr. Utterberg additional
shares of our common stock in the event we are required to
indemnify him for certain breaches or failures. Pursuant to the
terms of the stock purchase agreement and the consulting
agreement, we and Mr. Utterberg have agreed to indemnify
each other in the event of certain breaches or failures under
such agreements. Indemnification amounts payable by either
party, if any, must be paid in shares of our common stock,
valued at the time of payment. However, we will not be required
to issue shares for indemnification purposes that in the
aggregate would exceed 20% of the then outstanding shares of our
common stock without first obtaining stockholder approval, and
any such shares will not be registered under the Securities Act
of 1933, as amended. For a further discussion of indemnification
see The Stock Purchase
Agreement Indemnification beginning on
page 74. |
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When does NxStage expect to complete the Stock Purchase? |
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Subject to satisfaction or waiver of all conditions, we expect
to complete the Stock Purchase approximately two days following
the special meeting. |
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For a description of the conditions to completion of the Stock
Purchase, see The Stock Purchase Agreement
Conditions to the Completion of the Stock Purchase
beginning on page 68. |
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Are there risks you should consider in deciding whether to
vote for the issuance of the Stock Purchase Shares? |
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Yes. In evaluating the issuance of the Stock Purchase Shares,
you should carefully consider the factors discussed under the
heading Risk Factors beginning on page 18. |
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Why are we proposing to amend the 2005 Plan to increase the
number of shares issuable under the plan? |
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If the Stock Purchase is completed, our employee population will
grow from approximately 300 to over 1,000. In order for us to
grant equity incentives to these new employees and to support
our continued growth and compensation needs, we are seeking to
increase the number of shares available for issuance under the
2005 Plan by 3,800,000 shares, of which no more than
1,500,000 shares may be issued as restricted stock awards. |
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What vote is required by NxStage stockholders to approve the
issuance of the Stock Purchase Shares and the 2005 Plan
Amendment? |
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Pursuant to applicable NASDAQ Marketplace Rules and our by-laws,
the affirmative vote of the holders of a majority of the shares
of our common stock represented in person or by proxy and voting
on such matter at a special meeting at which a quorum is present
is required to approve the issuance of the Stock Purchase
Shares. In addition, pursuant to NASDAQ Marketplace Rules, our
bylaws and the terms of our 2005 Plan, the affirmative vote
of the holders of a majority of the shares of our common stock
represented in person or by proxy and voting on such matter at a
special meeting at which a quorum is present is required to
approve the proposed amendment to our 2005 Plan. As of
July 31, 2007, our directors and executive officers and
their affiliates, including Mr. Utterberg, were entitled to
vote approximately 32.5% of our outstanding shares of common
stock (not including options, warrants or other convertible
securities). |
|
Q: |
|
What do you need to do now? |
|
A: |
|
We urge you to carefully read and consider the information
contained in this document, including the annexes, and to
consider how the Stock Purchase, including the issuance of the
Stock Purchase Shares, and the proposal to increase the number
of shares available for issuance under our 2005 Plan will affect
you as a stockholder. You should then vote as soon as possible
in accordance with the instructions provided in this document
and on the enclosed proxy card. |
3
|
|
|
Q: |
|
When and where is the special meeting? |
|
A: |
|
The special meeting of our stockholders will be held at the
offices of WilmerHale, 60 State Street, Boston, Massachusetts
02109,
on ,
2007 at a.m., local time. |
|
Q: |
|
How do you vote? |
|
A: |
|
If you are a record holder, meaning your shares are registered
in your name, you may vote: |
|
|
|
(1) Over the
Internet: Go to the website of our tabulator,
Computershare Investor Services, at www.investorvote.com.
Use the vote control number printed on your enclosed proxy card
to access your account and vote your shares. You must specify
how you want your shares voted or your Internet vote cannot be
completed and you will receive an error message. Your shares
will be voted according to your instructions.
|
|
|
|
(2) By Telephone: Call
1-800-652-VOTE
(8683) toll free from the United States, Canada and Puerto
Rico, and follow the instructions on your enclosed proxy card.
You must specify how you want your shares voted and confirm your
vote at the end of the call or your telephone vote cannot be
completed. Your shares will be voted according to your
instructions.
|
|
|
|
(3) By Mail: Complete
and sign your enclosed proxy card and mail it in the enclosed
postage prepaid envelope to Computershare Investor Services.
Your shares will be voted according to your instructions. If you
do not specify how you want your shares voted, they will be
voted as recommended by our board of directors.
|
|
|
|
(4) In Person at the Special
Meeting: If you attend the special meeting, you
may deliver your completed proxy card in person or you may vote
by completing a ballot, which we will provide to you at the
meeting.
|
|
|
|
If your shares are held in street name, meaning they
are held for your account by a broker or other nominee, you may
vote: |
|
|
|
(1) Over the Internet or by
Telephone: You will receive instructions from
your broker or other nominee if they permit Internet or
telephone voting. You should follow those instructions.
|
|
|
|
(2) By Mail: You will
receive instructions from your broker or other nominee
explaining how you can vote your shares by mail. You should
follow those instructions.
|
|
|
|
(3) In Person at the Special
Meeting: Contact your broker or other nominee who
holds your shares to obtain a brokers proxy card and bring
it with you to the special meeting. You will not be able to
vote in person at the special meeting unless you have a proxy
from your broker issued in your name giving you the right to
vote your shares.
|
|
Q: |
|
What happens if you do not vote? |
|
A: |
|
If you do not vote at the special meeting by submitting a proxy
or otherwise, your shares will not be counted as present for the
purpose of determining a quorum and will have no effect on the
outcome of the proposal to approve the issuance of the Stock
Purchase Shares or the proposal to increase the number of shares
issuable under our 2005 Plan. If you submit a proxy card and
affirmatively elect to abstain from voting, your proxy will be
counted as present for the purpose of determining the presence
of a quorum but will not be voted at the special meeting. If you
hold shares in street name and do not instruct your broker how
to vote your shares, your shares will be counted as present for
the purpose of determining the presence of a quorum but will not
be voted at the special meeting. As a result, your abstention
will have the same effect as a vote against such
proposals. A broker non-vote will have no effect on,
and will not be counted towards, the total vote. Each of the
proposals to be considered at the special meeting requires the
affirmative vote of a majority of the votes cast at the special
meeting. |
4
|
|
|
Q: |
|
Can you change your vote after you have mailed your signed
proxy? |
|
A: |
|
Yes. If you want to change your vote, send our corporate
secretary a later dated, signed proxy card before the special
meeting or attend the special meeting and vote in person, or you
may vote over the Internet or by telephone as only your latest
Internet or telephone vote received before the special meeting
will be counted. You may also revoke your proxy by sending
written notice to our corporate secretary before the special
meeting. If you have instructed your broker to vote your shares,
you must follow your brokers directions in order to change
those instructions. |
|
Q: |
|
Are you entitled to appraisal rights? |
|
A: |
|
Our stockholders are not entitled to appraisal rights in
connection with any proposals to be considered at the special
meeting. |
|
Q: |
|
Who will bear the costs of the proxy solicitation? |
|
A: |
|
We will bear the costs of soliciting proxies, including the
printing, mailing and filing of this proxy statement and any
additional information furnished to stockholders. We have
engaged Georgeson Shareholder Communications Inc., a proxy
solicitation firm, to solicit proxies from our stockholders. For
these services, we expect to pay a fee of approximately $7,500,
plus expenses. Our directors, officers and employees may also
solicit proxies by telephone, email, facsimile and in person,
without additional compensation. Upon request, we will reimburse
brokerage houses and other custodians, nominees and fiduciaries
for their reasonable out-of-pocket expenses for distributing
proxy materials. |
|
Q: |
|
Whom should you call with questions? |
|
A: |
|
If you have any questions about the Stock Purchase or any of the
proposals to be considered at the special meeting, or if you
need additional copies of this document or the enclosed proxy,
you should contact: |
|
|
|
Georgeson Shareholder
Communications Inc.
17 State Street, 10th Floor
New York, NY 10004
(888) 605-7618
|
|
NxStage Medical, Inc.
439 South Union Street,
5th
Floor
Lawrence, Massachusetts 08143
(978) 687-4700
Attention: General Counsel
|
You may
also obtain additional information about us from documents filed
with the Securities and Exchange Commission by following the
instructions under Where You Can Find More
Information on page 174.
5
This summary highlights only selected information from this
proxy statement and may not contain all of the information that
is important to you. To better understand the Stock Purchase and
the proposals being considered at the special meeting, you
should read this entire proxy statement carefully, including the
stock purchase agreement, attached as Annex A, the opinion
of Merrill Lynch, Pierce, Fenner & Smith Incorporated,
attached as Annex B, and the other documents to which we
refer. You may obtain further information about us by following
the instructions under the heading Where You Can Find More
Information on page 174. We have included page
references parenthetically to direct you to a more complete
description of the topics presented in this summary.
The
Stock Purchase and the Stock Purchase Agreement (see
pages 55 and 68)
We have agreed to acquire the equity interests in the MDS
Entities held by Mr. Utterberg. Following the Stock
Purchase, each of the MDS Entities will be a direct or indirect
wholly-owned subsidiary of ours. In consideration for the Stock
Purchase, we will issue 6,500,000 shares of our common
stock to Mr. Utterberg, subject to a post-closing working
capital adjustment that may increase or decrease the number of
shares of our common stock to be issued to Mr. Utterberg.
In addition, we may be required to issue additional shares of
common stock to Mr. Utterberg in the event we are required
to indemnify him for certain breaches or failures. Following the
consummation of the Stock Purchase, Mr. Utterberg will own
approximately 23.4% of our outstanding common stock, assuming he
is issued 6,500,000 shares of our common stock.
Mr. Utterberg is currently a member of our board of
directors. He will continue to be a director following the
closing of the Stock Purchase.
The stock purchase agreement, which is the legal document
governing the Stock Purchase, is attached as Annex A to
this document. You should read the entire agreement carefully
and in its entirety.
Parties
to the Stock Purchase
NxStage
Medical, Inc.
439
South Union Street,
5th
Floor
Lawrence, Massachusetts 08143
(978) 687-4700
We are a medical device company that develops, manufactures and
markets innovative systems for the treatment of end-stage renal
disease, or ESRD, and acute kidney failure. We market our
principal product, the System One, to dialysis clinics for
chronic hemodialysis treatment, providing clinics with improved
access to the developing home hemodialysis market and the
ability to expand their patient base by adding home-based
patients without adding clinic infrastructure.
We were incorporated on December 31, 1998, under the name
QB Medical, Inc. and changed our name to NxStage Medical, Inc.
in 1999. Our principal offices are located at 439 South Union
Street,
5th Floor,
Lawrence, Massachusetts 08143, and our telephone number at that
address is
(978) 687-4700.
David S.
Utterberg
c/o Medisystems Corporation
701
Pike Street,
16th
Floor
Seattle, Washington 98101
(206) 834-1200
Medisystems, the business we are acquiring from
Mr. Utterberg, is a medical device company that designs,
manufactures, assembles, imports and distributes disposables
used in dialysis and related blood treatments and procedures.
Medisystems is a leader in the market for hemodialysis blood
tubing sets, A.V. fistula needles, apheresis needles and
hemodialysis transducer protectors in the United States.
Medisystems is also the sole supplier of the disposable
cartridges used in our primary product, the System One.
6
Mr. Utterberg, a NxStage director, is the sole stockholder
of MDS, a Washington corporation incorporated in 1981, and MDS
Services, a Nevada corporation incorporated in 1998.
Mr. Utterberg is also the owner of 90% of the issued and
outstanding shares of MDS Italy, a company organized in 1991
under the laws of Italy in Sorbara, Modena, Italy, and 0.273% of
the issued and outstanding equity participation of MDS Mexico, a
company organized in 1993 under the laws of Mexico in Tijuana,
Baja California, Mexico. MDS holds the remaining issued and
outstanding equity interests in each of MDS Italy and MDS Mexico.
Mr. Utterberg is also the sole stockholder of Medisystems
Technology Corporation, or MTC, Medisystems Research
Corporation, or MRC, Life Stream Medical Corporation, or LSM,
and Infusion Care Services, or ICS, which entities we are not
acquiring in connection with the Stock Purchase. In this proxy
statement, MTC, MRC, LSM, ICS and the MDS Entities are
collectively referred to as the Medisystems Group. Unless
otherwise indicated, all financial data presented in this proxy
statement with respect to Medisystems is the financial data of
the Medisystems Group.
Amendment
to Our 2005 Plan (see page 49)
Our board of directors has approved, subject to stockholder
approval, an amendment to our 2005 Plan, increasing from
3,601,459 to 7,401,459 the number of shares of our common stock
issuable under the 2005 Plan; provided that of this
3,800,000 share increase, no more than
1,500,000 shares may be issued as restricted stock awards.
Recommendations
of the NxStage Board of Directors (see pages 49 and
54)
After careful consideration, our board of directors determined
that the Stock Purchase is advisable, and in the best interests,
of NxStage and our stockholders, and has approved the Stock
Purchase. Our board of directors recommends that our
stockholders vote FOR the issuance of the
Stock Purchase Shares. Mr. Utterberg did not participate in
our discussions or consideration of, or the board votes
authorizing the Stock Purchase.
After careful consideration, our board of directors determined
that the amendment to our 2005 Plan to increase the number of
shares issuable thereunder is in the best interests of NxStage
and our stockholders. Our board of directors recommends that our
stockholders vote FOR the approval of the
amendment to our 2005 Plan.
Opinion
of NxStages Financial Advisor Regarding the Stock Purchase
(see page 59)
On June 4, 2007, Merrill Lynch delivered its written
opinion to our board of directors that, as of that date and
subject to the assumptions, considerations and limitations set
forth in its opinion, the Stock Purchase was fair, from a
financial point of view, to us. Merrill Lynch provided its
opinion for the information and assistance of our board of
directors in connection with its consideration of the Stock
Purchase. The Merrill Lynch opinion is not a recommendation as
to how any NxStage stockholder should vote or take any other
action with respect to the proposal to approve the issuance the
Stock Purchase Shares.
The full text of the written opinion of Merrill Lynch, which
sets forth assumptions made, matters considered and limitations
on the review undertaken in connection with its opinion, is
attached to this proxy statement as Annex B. You are urged
to read the opinion carefully and in its entirety. You should
carefully consider the discussion of Merrill Lynchs
analysis under the heading Opinion of NxStages
Financial Advisor beginning on page 59.
Interests
of Mr. Utterberg in the Stock Purchase (see
page 65)
When considering the recommendation of our board of directors,
you should be aware that Mr. Utterberg, a NxStage director,
has interests in the Stock Purchase that are different from
yours. Mr. Utterberg owns, directly or indirectly, all of
the equity interests in the MDS Entities. Mr. Utterberg
will receive 6,500,000 shares of our common stock, subject
to a post-closing working capital adjustment, if the Stock
Purchase is approved and completed. As a result,
Mr. Utterbergs aggregate ownership of our outstanding
stock will increase to
7
approximately 23.4% of our outstanding common stock, assuming he
receives 6,500,000 shares. Additionally, in connection with
the Stock Purchase we will enter into a two-year consulting
agreement with Mr. Utterberg pursuant to which we will pay
him $200,000 annually, plus reimbursement of certain expenses,
and we will receive through our ownership of MDS a license to
patents and other intellectual property rights from DSU Medical
Corporation, a corporation wholly-owned by Mr. Utterberg.
The consulting agreement and license agreement are each more
fully detailed in this proxy statement under the heading
License Agreement and Consulting Agreement beginning
on page 75.
Given his interests in the Stock Purchase and related
transactions, Mr. Utterberg did not participate in
discussions held by our board of directors concerning these
transactions, nor did he participate in the board votes
authorizing these transactions. In addition, the Stock Purchase
and consulting arrangement with Mr. Utterberg are related person
transactions for purposes of applicable rules of the Securities
and Exchange Commission, or SEC, and our internal policies
concerning related persons. Accordingly, our Audit Committee, as
well as our board of directors, reviewed and approved the
transactions. Our policies and procedures regarding the review,
approval and ratification of related person transactions are
described under the heading NxStage Certain Relationships
and Related Transactions beginning on page 168.
Following the Stock Purchase, Mr. Utterberg will continue
to serve on our board of directors. In addition, the stock
purchase agreement provides that, if Mr. Utterberg is no
longer a director of NxStage, our board of directors will
nominate for election to our board any director nominee proposed
by Mr. Utterberg, subject to certain conditions. Our board
of directors took into account these interests in considering
whether to approve the Stock Purchase.
Vote
Required to Approve the Stock Purchase and the 2005 Plan
Amendment
Pursuant to applicable NASDAQ Marketplace Rules and our by-laws,
the affirmative vote of the holders of a majority of the shares
of our common stock present and voting on the matter at the
special meeting is required to approve the issuance of the Stock
Purchase Shares to Mr. Utterberg. Pursuant to applicable
NASDAQ Marketplace Rules, our bylaws and the Plan, the
affirmative vote of the holders of a majority of the shares of
our common stock present and voting on the matter at the special
meeting is required to approve the amendment to our 2005 Plan.
Conditions
to Completion of the Stock Purchase (see page 68)
Several conditions must be satisfied or waived before we and
Mr. Utterberg complete the Stock Purchase, including those
summarized below:
|
|
|
|
|
expiration or termination of applicable waiting periods under
the
Hart-Scott-Rodino
Act;
|
|
|
|
approval by our stockholders of the issuance of shares of our
common stock to Mr. Utterberg in connection with the Stock
Purchase;
|
|
|
|
receipt by each party of the waivers, permits, consents,
approvals or other authorizations required to complete the Stock
Purchase, as specified in the stock purchase agreement;
|
|
|
|
filing by us of all filings required to be filed with NASDAQ;
|
|
|
|
accuracy of each partys respective representations and
warranties in the stock purchase agreement;
|
|
|
|
compliance by each party with its covenants in the stock
purchase agreement; and
|
|
|
|
absence of court orders or legal proceedings that would prevent
the consummation of the Stock Purchase, cause the Stock Purchase
to be rescinded or have a material adverse effect on the MDS
Entities.
|
Termination
of the Stock Purchase Agreement Under Specified Circumstances
(see page 72)
Under circumstances specified in the stock purchase agreement,
either we or Mr. Utterberg may terminate the stock purchase
agreement and, as a result, the Stock Purchase would not be
completed. These circumstances generally include if:
|
|
|
|
|
the Stock Purchase is not completed on or before
December 31, 2007;
|
8
|
|
|
|
|
we or Mr. Utterberg breach any representation, warranty or
covenant contained in the stock purchase agreement, and such
breach remains uncured, such that the conditions to the
completion of the Stock Purchase regarding representations,
warranties and covenants would not be satisfied;
|
|
|
|
our stockholders do not approve the issuance of shares of our
common stock to Mr. Utterberg pursuant to the stock
purchase agreement; or
|
|
|
|
we and Mr. Utterberg consent to the termination of the
stock purchase agreement by mutual written agreement.
|
NxStage
May be Required to Pay a Termination Fee Under Specified
Circumstances (see page 72)
Under certain circumstances, we may be required to pay a
termination fee to Mr. Utterberg up to an aggregate of
$600,000 in reasonable documented expenses incurred by
Mr. Utterberg relating to the Stock Purchase.
U.S.
Federal Income Tax Consequences of the Stock Purchase (see
page 67)
No gain or loss will be recognized by us or by holders of shares
of our common stock as a result of the Stock Purchase.
Anticipated
Accounting Treatment
We will account for the Stock Purchase as a purchase under
U.S. generally accepted accounting principles, or GAAP.
Under the purchase method of accounting, the assets and
liabilities of the MDS Entities will be recorded as of the date
of the closing of the Stock Purchase, at their respective fair
values, and consolidated with those of NxStage. The results of
operations of the MDS Entities will be consolidated with ours
beginning on the date of the Stock Purchase.
Share
Ownership of Directors and Executive Officers of NxStage (see
page 171)
At the close of business on the record date of our special
meeting, our directors and executive officers and their
affiliates, including Mr. Utterberg, beneficially owned and
were entitled to vote
approximately % of the shares of
our common stock outstanding on that date.
Regulatory
Approvals (see page 67)
We are not aware of any governmental or regulatory approval
required for completion of the Stock Purchase, other than
compliance with the
Hart-Scott-Rodino
Act, compliance with applicable corporate laws of Delaware,
compliance with state securities laws and the filing with the
NASDAQ Global Market of a Notification Form for Listing
Additional Shares and a Notification Form for Change in the
Number of Shares Outstanding, with respect to the shares of our
common stock to be issued to Mr. Utterberg pursuant to the
stock purchase agreement.
If any other governmental approvals or actions are required, we
intend to try to obtain them. We cannot assure you, however,
that we will be able to obtain any such approvals or actions.
Appraisal rights are not available under the Delaware General
Corporation Law with respect to the Stock Purchase.
9
SUMMARY
SELECTED HISTORICAL CONSOLIDATED FINANCIAL DATA OF
NxSTAGE
The following tables present our summary selected consolidated
statements of operations data and balance sheet data for our
fiscal years 2002 through 2006 and for the six months ended
June 30, 2006 and 2007. The selected financial data as of
December 31, 2005 and 2006 and for the years ended
December 31, 2004, 2005 and 2006 have been derived from our
consolidated financial statements, which have been audited by
Ernst & Young LLP, an independent registered public
accounting firm, included in this proxy statement beginning on
page F-16.
The selected consolidated financial data as of December 31,
2002, 2003 and 2004 and for the years ended December 31,
2002 and 2003, are derived from our consolidated financial
statements, which have been audited by Ernst & Young LLP,
an independent registered accounting firm, not included in this
proxy statement. The selected consolidated financial data as of
June 30, 2007 and for the six months ended June 30,
2006 and 2007 are derived from our unaudited consolidated
financial statements, which are included in this proxy statement
beginning on page
F-2. Our
unaudited consolidated financial statements have been prepared
on the same basis as the audited financial statements and notes
thereto, and include, in the opinion of our management, all
adjustments necessary for a fair presentation of the information
for the unaudited interim period. Reclassifications have been
made to our results from prior years to conform to the current
presentation. You should read this information in conjunction
with our consolidated financial statements, including the
related notes, and NxStage Managements Discussion
and Analysis of Financial Conditions and Results of
Operations included elsewhere in this proxy statement. The
historical results are not necessarily indicative of results to
be expected in any future period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
Years Ended December 31,
|
|
|
June 30,
|
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
2006
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
(In thousands, except share and per share data)
|
|
Consolidated Statements of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
30
|
|
|
$
|
286
|
|
|
$
|
1,885
|
|
|
$
|
5,994
|
|
|
$
|
20,812
|
|
|
$
|
7,947
|
|
|
$
|
18,405
|
|
Cost of revenues
|
|
|
404
|
|
|
|
940
|
|
|
|
3,439
|
|
|
|
9,585
|
|
|
|
26,121
|
|
|
|
10,861
|
|
|
|
21,428
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (deficit)
|
|
|
(374
|
)
|
|
|
(654
|
)
|
|
|
(1,554
|
)
|
|
|
(3,591
|
)
|
|
|
(5,309
|
)
|
|
|
(2,914
|
)
|
|
|
(3,023
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
2,286
|
|
|
|
2,181
|
|
|
|
3,334
|
|
|
|
7,550
|
|
|
|
14,356
|
|
|
|
6,952
|
|
|
|
9,851
|
|
Research and development
|
|
|
5,913
|
|
|
|
4,526
|
|
|
|
5,970
|
|
|
|
6,305
|
|
|
|
6,431
|
|
|
|
3,355
|
|
|
|
2,854
|
|
Distribution
|
|
|
6
|
|
|
|
33
|
|
|
|
495
|
|
|
|
2,059
|
|
|
|
7,093
|
|
|
|
2,808
|
|
|
|
5,342
|
|
General and administrative
|
|
|
2,554
|
|
|
|
2,868
|
|
|
|
3,604
|
|
|
|
4,855
|
|
|
|
8,703
|
|
|
|
4,124
|
|
|
|
5,193
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
10,759
|
|
|
|
9,608
|
|
|
|
13,403
|
|
|
|
20,769
|
|
|
|
36,583
|
|
|
|
17,239
|
|
|
|
23,240
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(11,133
|
)
|
|
|
(10,262
|
)
|
|
|
(14,957
|
)
|
|
|
(24,360
|
)
|
|
|
(41,892
|
)
|
|
|
(20,153
|
)
|
|
|
(26,263
|
)
|
Interest and other income
|
|
|
222
|
|
|
|
146
|
|
|
|
130
|
|
|
|
643
|
|
|
|
3,236
|
|
|
|
1,203
|
|
|
|
1,736
|
|
Interest and other expense
|
|
|
(69
|
)
|
|
|
(92
|
)
|
|
|
(15
|
)
|
|
|
(763
|
)
|
|
|
(973
|
)
|
|
|
(694
|
)
|
|
|
(348
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(10,980
|
)
|
|
$
|
(10,208
|
)
|
|
$
|
(14,842
|
)
|
|
$
|
(24,480
|
)
|
|
$
|
(39,629
|
)
|
|
$
|
(19,643
|
)
|
|
$
|
(24,875
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(4.66
|
)
|
|
$
|
(4.10
|
)
|
|
$
|
(5.81
|
)
|
|
$
|
(4.31
|
)
|
|
$
|
(1.60
|
)
|
|
$
|
(0.90
|
)
|
|
$
|
(0.84
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in per share
calculations
|
|
|
2,355,527
|
|
|
|
2,489,688
|
|
|
|
2,555,605
|
|
|
|
5,680,566
|
|
|
|
24,817,020
|
|
|
|
21,815,098
|
|
|
|
29,488,097
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
|
|
|
As of
|
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
June 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
(In thousands)
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
short-term investments
|
|
$
|
4,028
|
|
|
$
|
8,881
|
|
|
$
|
18,134
|
|
|
$
|
61,223
|
|
|
$
|
61,802
|
|
|
|
|
|
|
$
|
52,967
|
|
Working capital
|
|
|
5,235
|
|
|
|
11,115
|
|
|
|
19,205
|
|
|
|
62,101
|
|
|
|
64,715
|
|
|
|
|
|
|
|
56,862
|
|
Total assets
|
|
|
7,983
|
|
|
|
13,613
|
|
|
|
25,455
|
|
|
|
76,575
|
|
|
|
101,725
|
|
|
|
|
|
|
|
113,169
|
|
Long-term liabilities
|
|
|
146
|
|
|
|
30
|
|
|
|
3,006
|
|
|
|
2,106
|
|
|
|
5,494
|
|
|
|
|
|
|
|
17,158
|
|
Redeemable preferred stock
|
|
|
40,006
|
|
|
|
55,946
|
|
|
|
75,946
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated deficit
|
|
|
(34,368
|
)
|
|
|
(44,623
|
)
|
|
|
(59,496
|
)
|
|
|
(84,011
|
)
|
|
|
(123,640
|
)
|
|
|
|
|
|
|
(148,516
|
)
|
Total stockholders equity
(deficit)
|
|
|
(33,271
|
)
|
|
|
(43,478
|
)
|
|
|
(57,400
|
)
|
|
|
67,354
|
|
|
|
83,408
|
|
|
|
|
|
|
|
78,273
|
|
10
SUMMARY
SELECTED HISTORICAL COMBINED
FINANCIAL DATA OF MEDISYSTEMS GROUP
The following tables present a summary of the Medisystems Group
combined statements of operations data and balance sheet data
for its fiscal years 2002 through 2006 and for the six months
ended June 30, 2006 and 2007. The selected financial data
as of December 31, 2005 and 2006 and for the years ended
December 31, 2004, 2005 and 2006 have been derived from the
audited combined financial statements of the Medisystems Group,
which have been audited by Grant Thornton LLP, an independent
registered public accounting firm, and are included in this
proxy statement beginning on
page F-42.
The selected combined financial data as of December 31,
2004 have been derived from the audited combined financial
statements of the Medisystems Group, which have been audited by
Grant Thornton LLP, an independent registered public accounting
firm, not included in this proxy statement. The selected
financial data as of December 31, 2002 and 2003 and for the
years ended December 31, 2002 and 2003, are derived from
the audited combined financial statements of the Medisystems
Group, which have been audited by another independent registered
public accounting firm, not included in this proxy statement.
The selected combined financial data as of June 30, 2007
and for the six months ended June 30, 2006 and 2007 are
derived from Medisystems Group unaudited combined financial
statements, which are included in this proxy statement beginning
on
page F-42.
The unaudited combined financial statements of the Medisystems
Group have been prepared on the same basis as the audited
financial statements and notes thereto, and include, in the
opinion of the management of the Medisystems Group companies,
all normal recurring adjustments necessary for a fair
presentation of the information for the unaudited interim
period. Reclassifications have been made to results from prior
years to conform to the current presentation. These interim
results are not necessarily an indication of the results for the
full year. You should read this information in conjunction with
the combined financial statements of the Medisystems Group,
including the related notes, and Medisystems
Managements Discussion and Analysis of Financial
Conditions and Results of Operations included elsewhere in
this proxy statement. The historical results are not necessarily
indicative of results to be expected in any future period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
Years Ended December 31,
|
|
|
June 30,
|
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
2006
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
(In thousands)
|
|
|
Combined Statements of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
83,515
|
|
|
$
|
53,645
|
|
|
$
|
62,848
|
|
|
$
|
57,904
|
|
|
$
|
62,577
|
|
|
$
|
30,565
|
|
|
$
|
32,028
|
|
Cost of revenues
|
|
|
59,358
|
|
|
|
41,608
|
|
|
|
46,653
|
|
|
|
44,227
|
|
|
|
47,782
|
|
|
|
23,119
|
|
|
|
23,275
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
24,157
|
|
|
|
12,037
|
|
|
|
16,195
|
|
|
|
13,677
|
|
|
|
14,795
|
|
|
|
7,446
|
|
|
|
8,753
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
2,589
|
|
|
|
1,835
|
|
|
|
1,916
|
|
|
|
2,175
|
|
|
|
2,280
|
|
|
|
1,278
|
|
|
|
922
|
|
Research and development
|
|
|
1,686
|
|
|
|
1,464
|
|
|
|
1,638
|
|
|
|
2,186
|
|
|
|
2,317
|
|
|
|
1,103
|
|
|
|
877
|
|
Distribution
|
|
|
1,488
|
|
|
|
975
|
|
|
|
1,172
|
|
|
|
1,187
|
|
|
|
1,238
|
|
|
|
684
|
|
|
|
491
|
|
General and administrative
|
|
|
4,594
|
|
|
|
6,442
|
|
|
|
7,719
|
|
|
|
4,540
|
|
|
|
4,382
|
|
|
|
1,867
|
|
|
|
1,779
|
|
Royalty Expense
|
|
|
7,350
|
|
|
|
4,350
|
|
|
|
4,350
|
|
|
|
4,350
|
|
|
|
4,350
|
|
|
|
2,175
|
|
|
|
2,661
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
17,707
|
|
|
|
15,066
|
|
|
|
16,795
|
|
|
|
14,438
|
|
|
|
14,567
|
|
|
|
7,107
|
|
|
|
6,730
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations
|
|
|
6,450
|
|
|
|
(3,029
|
)
|
|
|
(600
|
)
|
|
|
(761
|
)
|
|
|
228
|
|
|
|
339
|
|
|
|
2,023
|
|
Legal settlement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,629
|
|
|
|
|
|
|
|
|
|
Interest and other income
|
|
|
691
|
|
|
|
214
|
|
|
|
416
|
|
|
|
324
|
|
|
|
284
|
|
|
|
140
|
|
|
|
149
|
|
Interest and other expense
|
|
|
(10
|
)
|
|
|
(43
|
)
|
|
|
(29
|
)
|
|
|
(5
|
)
|
|
|
(251
|
)
|
|
|
(199
|
)
|
|
|
(109
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before provision for
foreign income taxes
|
|
|
7,131
|
|
|
|
(2,858
|
)
|
|
|
(213
|
)
|
|
|
(442
|
)
|
|
|
5,890
|
|
|
|
280
|
|
|
|
2,063
|
|
Provision for foreign income taxes
|
|
|
(206
|
)
|
|
|
(261
|
)
|
|
|
(140
|
)
|
|
|
(175
|
)
|
|
|
(199
|
)
|
|
|
(91
|
)
|
|
|
(126
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
6,925
|
|
|
$
|
(3,119
|
)
|
|
$
|
(353
|
)
|
|
$
|
(617
|
)
|
|
$
|
5,691
|
|
|
$
|
189
|
|
|
$
|
1,937
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical
|
|
|
|
|
|
|
As of
|
|
|
|
As of December 31,
|
|
|
June 30,
|
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
short-term investments
|
|
$
|
5,060
|
|
|
$
|
4,396
|
|
|
$
|
2,918
|
|
|
$
|
2,501
|
|
|
$
|
1,622
|
|
|
$
|
941
|
|
Working capital
|
|
|
3,190
|
|
|
|
(2,430
|
)
|
|
|
(6,006
|
)
|
|
|
(6,640
|
)
|
|
|
(1,536
|
)
|
|
|
(137
|
)
|
Total assets
|
|
|
25,203
|
|
|
|
17,613
|
|
|
|
17,495
|
|
|
|
15,688
|
|
|
|
25,000
|
|
|
|
19,973
|
|
Long-term liabilities
|
|
|
524
|
|
|
|
641
|
|
|
|
778
|
|
|
|
725
|
|
|
|
785
|
|
|
|
773
|
|
Retained earnings (deficit)
|
|
|
7,325
|
|
|
|
206
|
|
|
|
(4,208
|
)
|
|
|
(4,825
|
)
|
|
|
866
|
|
|
|
2,543
|
|
Total stockholders equity
(deficit)
|
|
|
7,484
|
|
|
|
509
|
|
|
|
(3,818
|
)
|
|
|
(4,608
|
)
|
|
|
1,272
|
|
|
|
2,954
|
|
12
SUMMARY
SELECTED UNAUDITED PRO FORMA COMBINED
FINANCIAL DATA
In accordance with Article 11 of
Regulation S-X
under the Securities Act of 1933, as amended, we have prepared a
combined pro forma balance sheet as of June 30, 2007 and
combined pro forma statements of operations for the six months
ended June 30, 2007 and the fiscal year ended
December 31, 2006. For additional information, please refer
to the unaudited pro forma combined financial statements and
related notes beginning on page 131.
The following tables present our summary historical and pro
forma statement of operations data for the six months ended
June 30, 2007 and for the year ended December 31, 2006
and our summary historical and pro forma balance sheet data as
of June 30, 2007. The summary statements of operations data
for the year ended December 31, 2006 are derived from our
audited consolidated financial statements included in this proxy
statement beginning on page F-17. The summary statements of
operations data for the six months ended June 30, 2007 and
the selected balance sheet data as of June 30, 2007 have
been derived from our unaudited consolidated financial
statements included in this proxy statement beginning on
page F-2.
Our unaudited consolidated financial statements have been
prepared on the same basis as the audited consolidated financial
statements and notes thereto, and include, in the opinion of our
management, all adjustments necessary for a fair presentation of
the information for the unaudited interim period. Our historical
results for prior interim periods are not necessarily indicative
of results to be expected for a full fiscal year or for any
future period. You should read this data together with our
financial statements and related notes included in this proxy
statement beginning on page F-2 and the information under
Summary Selected Historical Consolidated Financial Data of
NxStage, Summary Selected Historical Combined
Financial Data of Medisystems Group, NxStage
Managements Discussion and Analysis of Financial
Conditions and Results of Operations and Medisystems
Managements Discussion and Analysis of Financial
Conditions and Results of Operations.
The following unaudited pro forma combined financial data should
be read in conjunction with our audited and unaudited historical
financial statements and those of the Medisystems Group and the
unaudited pro forma combined financial statements and related
notes included in this proxy statement beginning on
page 131. The unaudited pro forma combined financial data
has been presented for illustrative purposes only and is not
necessarily indicative of the results of operations or financial
position that would have occurred if the transaction had been
completed at the dates indicated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited
|
|
|
|
|
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
|
|
|
Combined
|
|
|
NxStage Historical
|
|
|
Pro Forma
|
|
|
|
NxStage Historical
|
|
|
Year Ended
|
|
|
Six Months Ended
|
|
|
Combined
|
|
|
|
Year Ended December 31,
|
|
|
December 31,
|
|
|
June 30,
|
|
|
Six Months Ended
|
|
|
|
2006
|
|
|
2006
|
|
|
2007
|
|
|
June 30, 2007
|
|
|
|
(In thousands, except share and per share amounts)
|
|
|
Combined Statements of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
20,812
|
|
|
$
|
78,886
|
|
|
$
|
18,405
|
|
|
$
|
46,744
|
|
Cost of revenues
|
|
|
26,121
|
|
|
|
69,917
|
|
|
|
21,428
|
|
|
|
41,193
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (deficit)
|
|
|
(5,309
|
)
|
|
|
8,969
|
|
|
|
(3,023
|
)
|
|
|
5,551
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses;
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
14,356
|
|
|
|
16,636
|
|
|
|
9,852
|
|
|
|
10,774
|
|
Research and development
|
|
|
6,431
|
|
|
|
7,892
|
|
|
|
2,854
|
|
|
|
3,362
|
|
Distribution
|
|
|
7,093
|
|
|
|
8,331
|
|
|
|
5,341
|
|
|
|
5,832
|
|
General and administrative
|
|
|
8,703
|
|
|
|
15,359
|
|
|
|
5,193
|
|
|
|
8,336
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
36,583
|
|
|
|
48,218
|
|
|
|
23,240
|
|
|
|
28,304
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited
|
|
|
|
|
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
|
|
|
Combined
|
|
|
NxStage Historical
|
|
|
Pro Forma
|
|
|
|
NxStage Historical
|
|
|
Year Ended
|
|
|
Six Months Ended
|
|
|
Combined
|
|
|
|
Year Ended December 31,
|
|
|
December 31,
|
|
|
June 30,
|
|
|
Six Months Ended
|
|
|
|
2006
|
|
|
2006
|
|
|
2007
|
|
|
June 30, 2007
|
|
|
|
(In thousands, except share and per share amounts)
|
|
|
Loss from operations
|
|
|
(41,892
|
)
|
|
|
(39,249
|
)
|
|
|
(26,263
|
)
|
|
|
(22,753
|
)
|
Interest and other income
|
|
|
3,236
|
|
|
|
3,518
|
|
|
|
1,736
|
|
|
|
1,885
|
|
Interest and other expense
|
|
|
(973
|
)
|
|
|
(1,224
|
)
|
|
|
(348
|
)
|
|
|
(457
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision for foreign
income taxes
|
|
|
(39,629
|
)
|
|
|
(36,955
|
)
|
|
|
(24,875
|
)
|
|
|
(21,325
|
)
|
Provision for foreign income taxes
|
|
|
|
|
|
|
199
|
|
|
|
|
|
|
|
(126
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(39,629
|
)
|
|
$
|
(37,154
|
)
|
|
$
|
(24,875
|
)
|
|
$
|
(21,451
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(1.60
|
)
|
|
$
|
(1.19
|
)
|
|
$
|
(0.84
|
)
|
|
$
|
(0.60
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in per share
calculations
|
|
|
24,817,020
|
|
|
|
31,317,020
|
|
|
|
29,488,097
|
|
|
|
35,988,097
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited
|
|
|
|
|
|
|
|
|
|
NxStage
|
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
Historical
|
|
|
Combined
|
|
|
|
|
|
|
|
|
|
As of
|
|
|
As of
|
|
|
|
|
|
|
|
|
|
June 30, 2007
|
|
|
June 30, 2007
|
|
|
|
|
|
|
|
|
|
(in thousands)
|
|
|
|
|
|
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
short-term investments
|
|
$
|
52,967
|
|
|
$
|
50,510
|
|
|
|
|
|
|
|
|
|
Working capital
|
|
|
56,862
|
|
|
|
53,916
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
113,169
|
|
|
|
210,693
|
|
|
|
|
|
|
|
|
|
Long-term liabilities
|
|
|
17,158
|
|
|
|
17,931
|
|
|
|
|
|
|
|
|
|
Accumulated deficit
|
|
|
(148,516
|
)
|
|
|
(148,516
|
)
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
78,273
|
|
|
|
159,523
|
|
|
|
|
|
|
|
|
|
14
COMPARATIVE
HISTORICAL AND UNAUDITED PRO FORMA PER SHARE DATA
The information below reflects the historical net loss and net
book value per share of our common stock in comparison with the
unaudited pro forma net loss and book value per share after
giving effect to the acquisition of the MDS Entities on a
purchase basis.
You should read the tables below in conjunction with the audited
and unaudited financial statements of NxStage beginning on page
F-2 and the audited and unaudited financial statements of the
Medisystems Group beginning on
page F-42
and the related notes and the unaudited pro forma combined
financial statements and related notes included elsewhere in
this proxy statement.
|
|
|
|
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
|
2007
|
|
|
NxStage
|
|
|
|
|
Historical Per Common Share
Data:
|
|
|
|
|
Net loss per common
share basic and diluted weighted-average shares
outstanding
|
|
$
|
(0.84
|
)
|
Net book value per share
outstanding
|
|
$
|
2.61
|
|
NxStage and
MDS Entities
|
|
|
|
|
Unaudited Pro Forma Combined
Per Common Share Data:
|
|
|
|
|
Net loss per common
share basic and diluted weighted-average shares
outstanding
|
|
$
|
(0.60
|
)
|
Net book value per pro forma share
outstanding
|
|
$
|
4.37
|
|
15
MARKET
PRICE AND DIVIDEND INFORMATION
Our common stock has been quoted on the NASDAQ Global Market
under the symbol NXTM since July 1, 2006, and
prior to that it was quoted on the NASDAQ National Market from
October 27, 2005 until June 30, 2006. Prior to that
time, there was no public market for our common stock.
The following table sets forth the high and low intraday sales
prices of our common stock as reported on the NASDAQ Global
Market for each of the periods set forth below.
|
|
|
|
|
|
|
|
|
|
|
High
|
|
|
Low
|
|
|
2007
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
14.20
|
|
|
$
|
7.90
|
|
Second Quarter
|
|
$
|
14.43
|
|
|
$
|
11.46
|
|
Third Quarter (through
August 27, 2007)
|
|
$
|
13.97
|
|
|
$
|
13.35
|
|
2006
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
15.17
|
|
|
$
|
11.50
|
|
Second Quarter
|
|
$
|
13.33
|
|
|
$
|
8.33
|
|
Third Quarter
|
|
$
|
10.18
|
|
|
$
|
7.11
|
|
Fourth Quarter
|
|
$
|
9.80
|
|
|
$
|
7.29
|
|
2005
|
|
|
|
|
|
|
|
|
Fourth Quarter
|
|
$
|
14.80
|
|
|
$
|
9.00
|
|
The last reported sale price of our common stock on the NASDAQ
Global Market on August 27, 2007 was $13.39 per share.
On July 31, 2007, the last trading day prior to
announcement of the Stock Purchase, the closing price of our
common stock was $12.11. Assuming the issuance of
6,500,000 shares of our common stock to Mr. Utterberg
on June 4, 2007, he would have realized approximately
$78.7 million in connection with the Stock Purchase.
Because the market price of our common stock is subject to
fluctuation, the value of the shares to be issued to Mr.
Utterberg in the Stock Purchase may increase or decrease.
As of July 31, 2007, we had approximately 86 holders
of record of our common stock. For detailed information
regarding the beneficial ownership of our common stock see
NxStage Principal Stockholders.
Market price data regarding the MDS Entities is not provided as
there is no public market for their equity. See Questions
and Answers for a summary of the ownership of the
outstanding equity of the MDS Entities.
Given the absence of a public trading market for the outstanding
equity of the MDS Entities, the foregoing per share market data
may not provide meaningful information to you in determining
whether to approve the issuance of the Stock Purchase Shares.
Our stockholders are urged to obtain current market quotations
for our common stock and to carefully review the other
information contained in this proxy statement or incorporated
herein by reference in considering whether to approve the
issuance of the Stock Purchase Shares. See Where you Can
Find More Information beginning on page 174.
We have never declared or paid any dividends on our common
stock. We currently intend to retain any future earnings to
finance our research and development efforts, the development of
our proprietary technologies and the expansion of our business
and do not intend to declare or pay cash dividends on our
capital stock in the foreseeable future. Any future
determination to pay dividends will be at the discretion of our
board of directors and will depend upon a number of factors,
including our results of operations, financial condition, future
prospects, contractual restrictions, restrictions imposed by
applicable law and other factors our board of directors deems
relevant.
16
Certain of the MDS Entities, which are S corporations, have paid
dividends to Mr. Utterberg for compensation and tax payment
purposes; however, no such dividends were declared or paid to
Mr. Utterberg during the years ended December 31, 2006
and December 31, 2005, during the six months ended
June 30, 2007, or during the period between June 30,
2007 and July 31, 2007. Pursuant to the terms of the stock
purchase agreement, Mr. Utterberg is permitted to receive
cash dividends from the MDS Entities (1) in the amount of
$55,000 per month for each month from January 1, 2007
through the closing of the Stock Purchase and (2) for
reimbursement of tax liability with respect to Medisystems.
17
In addition to the other information included in this proxy
statement, including the matters addressed under Special
Note Regarding Forward-Looking Statements, you should
carefully consider the following risks before deciding whether
to vote for the issuance of the shares of our common stock in
the Stock Purchase or the increase in the number of shares
issuable under our 2005 Plan. You should also consider the other
information in this proxy statement and the other documents
incorporated by reference into this proxy statement. See
Where You Can Find More Information. Risks relating
to NxStages business are described under Risks
Related to NxStage. Risks relating to the
Medisystems business are described under Risks
Related to the Combined Businesses Following the Stock
Purchase.
Risks
Related to the Stock Purchase
The
number of shares of common stock to be issued as consideration
for the Stock Purchase is not adjustable based on the market
price of our common stock and if the market price of our common
stock increases, the value of the shares of common stock issued
as consideration for the Stock Purchase to Mr. Utterberg
could increase.
The purchase price to be paid by us to Mr. Utterberg has
been set in the stock purchase agreement at 6,500,000 shares of
our common stock and is only adjustable upward or downward
depending upon the amount of Medisystems working capital, as
calculated pursuant to the stock purchase agreement, at the time
of the closing; the number of shares of our common stock that we
will issue will not be adjusted as a result of changes in the
market price of our common stock. Any changes in the market
price of our common stock will not affect the number of shares
received by Mr. Utterberg as consideration for the Stock
Purchase. Therefore, if the market price of our common stock
increases from the market price on the date of the Stock
Purchase, Mr. Utterberg would receive consideration with a
market value that is higher than the value on the date we
executed the stock purchase agreement or the date of this proxy
statement.
If the
working capital of Medisystems at the closing is less negative
than the target amount of working capital by $250,000 or more or
we are required to indemnify Mr. Utterberg for breaches or
failures under the stock purchase agreement or consulting
agreement, the number of shares to be issued to
Mr. Utterberg will be increased.
The stock purchase agreement provides that, if the working
capital of Medisystems at the closing is less negative than the
target amount of working capital, as determined pursuant to the
stock purchase agreement, by $250,000 or more, the number of
shares of our common stock to be issued to Mr. Utterberg
will be increased. The items that will constitute
Medisystems working capital at the closing are subject to
many factors. For a more detailed discussion of the calculation
of Medisystems working capital at the closing, see
The Stock Purchase Stock Purchase
Consideration Working Capital Adjustment Following
Closing on page 66.
If we are required to indemnify Mr. Utterberg for failures
or breaches under the stock purchase agreement or consulting
agreement, we will be required to satisfy any such
indemnification obligations with shares of our common stock,
valued at the time of payment. Our aggregate indemnification
liability is generally limited to a maximum amount equal to 50%
of the value of the shares issued as consideration for the Stock
Purchase, measured at the time the Stock Purchase closes, minus
$1,250,000. However, because any shares issued in satisfaction
of an indemnification claim will be valued at the time of
payment, we do not know the maximum number of shares that we may
required to issue to Mr. Utterberg. For a more detailed
discussion of the indemnification requirements under the stock
purchase agreement and consulting agreement, see The Stock
Purchase Agreement Indemnification on
page 74.
18
Failure
to complete the Stock Purchase could harm our common stock price
and future business and operations.
If the Stock Purchase is not completed, we may be subject to the
following risks:
|
|
|
|
|
the price of our common stock may decline;
|
|
|
|
we will not realize our expected benefits of the Stock Purchase;
|
|
|
|
under certain circumstances we will be required to pay
Mr. Utterberg a termination fee of up to $600,000 in
reasonable documented expenses incurred by him in connection
with the Stock Purchase; and
|
|
|
|
the costs incurred by us related to the Stock Purchase, such as
legal, accounting and certain financial advisory fees, must be
paid even if the Stock Purchase is not completed.
|
The
Stock Purchase may be completed even though material adverse
changes may result from the announcement of the Stock Purchase,
industry-wide changes and other causes.
In general, either party can refuse to complete the Stock
Purchase if there is a material adverse change affecting the
other party between June 4, 2007, the date of the stock
purchase agreement, and the closing. However, certain types of
changes do not permit either party to refuse to complete the
Stock Purchase, even if such change would have a material
adverse effect on us or Medisystems, including:
|
|
|
|
|
with respect to us, changes resulting from general economic
conditions or conditions generally affecting the industry in
which we operate;
|
|
|
|
changes due to the announcement of the Stock Purchase or the
completion of the transactions contemplated by the stock
purchase agreement; or
|
|
|
|
changes resulting from a change in the price of our common stock
excluding any underlying effect that may have caused such change.
|
If adverse changes occur but we and Mr. Utterberg must
still complete the Stock Purchase, our stock price may suffer.
Medisystems
KeyBank Credit Commitment is with all entities within the
Medisystems Group, and it is not a condition to closing that
this be modified. If the parties to the agreement are not
limited to the MDS Entities, Medisystems Group companies that
are not MDS Entities could borrow under the KeyBank commitment,
and we could be required to pay.
In January 2003, the Medisystems Group entered into a credit
agreement with KeyBank National Association, or KeyBank,
pursuant to which all of the assets of each Medisystems Group
company, including the assets of the MDS Entities, were pledged
as collateral. The credit agreement provides for a
$3.5 million revolving line of credit and a
$1.5 million demand line of credit. As of July 25,
2007, there were no amounts outstanding under the revolving line
of credit and Medisystems Group had issued approximately
$812,000 of standby letters of credit, which are securing
guarantees of VAT refunds made to MDS Italy by an Italian bank.
Medisystems has indicated that it will amend the KeyBank credit
commitment prior to the closing of the Stock Purchase to remove
from the commitment the Medisystems Group companies that we are
not acquiring. However, removal of these entities from the
KeyBank credit commitment is not within our control and is not a
condition to closing. While they remain parties to the credit
commitment, Medisystems Group companies that are not MDS
Entities may borrow under the credit facility, and, if they
default on any such obligations, we could be required to satisfy
the obligations.
19
The
market price of our common stock may decline as a result of the
Stock Purchase.
The market price of our common stock may decline as a result of
the Stock Purchase for a number of reasons including if:
|
|
|
|
|
we do not achieve the perceived benefits of the Stock Purchase
as rapidly or to the extent anticipated by financial or industry
analysts;
|
|
|
|
the effect of the Stock Purchase on our business and prospects
is not consistent with the expectations of financial or industry
analysts; or
|
|
|
|
investors react negatively to the effect on our business and
prospects from the Stock Purchase.
|
Our
stockholders may not realize a benefit from the Stock Purchase
commensurate with the ownership dilution they will experience in
connection with the Stock Purchase.
As consideration for the Stock Purchase, we expect to issue
6,500,000 shares of our common stock, or approximately 21.7% of
our outstanding common stock as of July 31, 2007. If we are
unable to realize the strategic and financial benefits currently
anticipated from the Stock Purchase, our stockholders will have
experienced substantial dilution of their ownership interest
without receiving commensurate benefit.
In addition to the other information contained in this proxy
statement and the other risk factors set forth herein, you
should carefully consider the following risks relating to
NxStages business.
Risks
Related to NxStages Business
We
expect to derive substantially all of our future revenues from
the rental or sale of our System One and the sale of our related
disposable products used with the System One.
Since our inception, we have devoted substantially all of our
efforts to the development of the System One and the related
products used with the System One. We commenced marketing the
System One and the related disposable products to the critical
care market in February 2003. We commenced marketing the System
One for chronic hemodialysis treatment in September 2004. We
expect that the rental or sale of the System One and the sale of
related products will account for substantially all of our
revenues for the foreseeable future. Most of our related
products cannot be used with any other dialysis systems and,
therefore, we will derive little or no revenues from related
products unless we sell or otherwise place the System One. To
the extent that the System One is not a successful product or is
withdrawn from the market for any reason, we do not have other
products in development that could replace revenues from the
System One.
We
cannot accurately predict the size of the home hemodialysis
market, and it may be smaller or slower to develop than we
expect.
Although home hemodialysis treatment options are available,
adoption has been limited. The most widely adopted form of
dialysis therapy used in a setting other than a dialysis clinic
is peritoneal dialysis. Based on the most recently available
data from the United States Renal Data System, or USRDS, the
number of patients receiving peritoneal dialysis was
approximately 26,000 in 2004, representing approximately 8% of
all patients receiving dialysis treatment for ESRD in the United
States. Very few ESRD patients receive hemodialysis treatment
outside of the clinic setting; USRDS data indicates
approximately 2,000 patients were receiving home-based
hemodialysis in 2004. Because the adoption of home hemodialysis
has been limited to date, the number of patients who desire to,
and are capable of, administering their own hemodialysis
treatment with a system such as the System One is unknown and
there is limited data upon which to make estimates. Our
long-term growth will depend on the number of patients who adopt
home-based hemodialysis and how quickly they adopt it, and we do
not know whether the number of home-based dialysis patients will
be greater or fewer than the number of patients performing
peritoneal dialysis or how many peritoneal dialysis patients
will switch to home-based hemodialysis. We received our home use
clearance for the System One from the FDA in June
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2005 and we will need to devote significant resources to
developing the market. We cannot be certain that this market
will develop, how quickly it will develop or how large it will
be.
We
will require significant capital to build our business, and
financing may not be available to us on reasonable terms, if at
all.
We believe that the chronic care market is the largest market
opportunity for our System One hemodialysis system.
Historically, we have typically billed the dialysis clinic for
the rental of the equipment and the sale of the related
disposable cartridges and treatment fluids. In our recent DaVita
agreement, DaVita agreed to purchase all of its System One
equipment then being rented from us and to buy a significant
percentage of its future System One equipment needs. It is not
clear what percentage of our future chronic customers will
purchase rather than rent System One equipment. However, it is
possible that a significant percentage of our chronic customers
will continue to rent rather than purchase System One equipment
and that, as a result, we will generate a significant percentage
of our revenues and cash flow from the use of the System One
over time rather than upfront from the sale of the System One
equipment. In this event, we will need significant amounts of
working capital to manufacture System One equipment for rental
to dialysis clinics.
We only recently began marketing our System One to dialysis
clinics for the treatment of ESRD, and we have not achieved
widespread market acceptance of our product. We may not be able
to generate sufficient cash flow to meet our capital needs. If
our existing resources are insufficient to satisfy our liquidity
requirements, we may need to sell additional equity or issue
debt securities. Any sale of additional equity or issuance of
debt securities may result in dilution to our stockholders, and
we cannot be certain that additional public or private financing
will be available in amounts or on terms acceptable to us, or at
all. If we are unable to obtain this additional financing when
needed, we may be required to delay, reduce the scope of, or
eliminate one or more aspects of our business development
activities, which could harm the growth of our business.
We
have limited operating experience, a history of net losses and
an accumulated deficit of $148.5 million at June 30,
2007. We cannot guarantee if, when and the extent that we will
become profitable, or that we will be able to maintain
profitability once it is achieved.
Since inception, we have incurred losses every quarter and at
June 30, 2007, we had an accumulated deficit of
approximately $(148.5) million. We expect to incur
increasing operating expenses as we continue to grow our
business. Additionally, in the chronic care market, the cost of
manufacturing the System One and related disposables currently
exceeds the market price. We cannot provide assurance that we
will be able to lower the cost of manufacturing the System One
and related disposables below the current chronic care market
price, that we will achieve profitability, when we will become
profitable, the sustainability of profitability should it occur,
or the extent to which we will be profitable. Our ability to
become profitable is dependent in part upon achieving a
sufficient scale of operations, obtaining better purchasing
terms and prices, achieving efficiencies in manufacturing
overhead costs, implementing design and process improvements to
lower our costs of manufacturing our products and achieving
efficient distribution of our products.
In March 2006, we received clearance from the FDA to market our
PureFlow SL module as an alternative to the bagged fluid
presently used with our System One in the chronic care market,
and we commercially launched the PureFlow SL module in July
2006. This accessory to the System One allows for the
preparation of high purity dialysate in the patients home
using ordinary tap water and dialysate concentrate. The PureFlow
SL is designed to help patients with ESRD more conveniently and
effectively manage their home hemodialysis therapy by
eliminating the need for bagged fluids. Since its launch,
PureFlow SL penetration has reached approximately 58% of all of
our chronic patients. The product is still early in its
commercial launch and we continue to work to improve product
reliability and user experience, based upon customer feedback.
Any failure to further improve reliability and user experience,
and thereby gain rapid market acceptance of the PureFlow SL
module, including converting our installed base of patients
currently using bagged fluid, could adversely affect our ability
to achieve profitability.
21
We
compete against other dialysis equipment manufacturers with much
greater financial resources and better established products and
customer relationships, which may make it difficult for us to
penetrate the market and achieve significant sales of our
products.
Our System One competes directly against equipment produced by
Fresenius Medical Care AG, Baxter Healthcare, Gambro AB, B.
Braun and others, each of which markets one or more FDA-cleared
medical devices for the treatment of acute or chronic kidney
failure.
To date, only one other company has had a hemodialysis product
specifically cleared for home use, Aksys Ltd., announced in
January the withdrawal of its product from the market. Products
sold by our other competitors have also been used in the home,
in particular Fresenius systems. Each of these competitors
offers products that have been in use for a longer time than our
System One and are more widely recognized by physicians,
patients and providers. These competitors have significantly
more financial and human resources, more established sales,
service and customer support infrastructures and spend more on
product development and marketing than we do. Many of our
competitors also have established relationships with the
providers of dialysis therapy and, Fresenius owns and operates a
chain of dialysis clinics. Most of these companies manufacture
additional complementary products enabling them to offer a
bundle of products and have established sales forces and
distribution channels that may afford them a significant
competitive advantage. One of our competitors, Gambro AB, has
been subject to an import hold imposed by the FDA on its acute
and chronic dialysis machines. This import hold has been
recently lifted, and it is not yet clear what the chronic and
acute market impact of this will be on our future revenues. We
believe the overall impact of the import hold has been positive
to us, however, we are not sure of the magnitude of the impact
this import hold has had on revenues.
The market for our products is competitive, subject to change
and affected by new product introductions and other market
activities of industry participants, including increased
consolidation of ownership of clinics by large dialysis chains.
If we are successful, our competitors are likely to develop
products that offer features and functionality similar to our
System One. Improvements in existing competitive products or the
introduction of new competitive products may make it more
difficult for us to compete for sales, particularly if those
competitive products demonstrate better safety, convenience or
effectiveness or are offered at lower prices than our System
One. Our ability to successfully market the System One could
also be adversely affected by pharmacological and technological
advances in preventing the progression of ESRD
and/or in
the treatment of acute kidney failure or fluid overload. If we
are unable to compete effectively against existing and future
competitors and existing and future alternative treatments and
pharmacological and technological advances, it will be difficult
for us to penetrate the market and achieve significant sales of
the System One.
Our
success will depend on our ability to achieve market acceptance
of our System One.
Our products have limited product and brand recognition and have
only been used at a limited number of dialysis clinics and
hospitals. In the chronic care market, we will have to convince
four distinct constituencies involved in the choice of dialysis
therapy, namely operators of dialysis clinics, nephrologists,
dialysis nurses and patients, that our system provides an
effective alternative to other existing dialysis equipment. Each
of these constituencies will use different considerations in
reaching their decision. Lack of acceptance by any of these
constituencies will make it difficult for us to grow our
business. We may have difficulty gaining widespread or rapid
acceptance of the System One for a number of reasons including:
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the failure by us to demonstrate to patients, operators of
dialysis clinics, nephrologists, dialysis nurses and others that
our product is equivalent or superior to existing therapy
options or, that the cost or risk associated with use of our
product is not greater than available alternatives;
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competition from products sold by companies with longer
operating histories and greater financial resources, more
recognizable brand names and better established distribution
networks and relationships with dialysis clinics;
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the ownership and operation of some dialysis providers by
companies that also manufacture and sell competitive dialysis
products;
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the introduction of competing products or treatments that may be
more effective, safer, easier to use or less expensive than ours;
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the number of patients willing and able to perform therapy
independently, outside of a traditional dialysis clinic, may be
smaller than we estimate; and
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the continued availability of satisfactory reimbursement from
healthcare payors, including Medicare.
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Current
Medicare reimbursement rates limit the price at which we can
market the System One, and adverse changes to reimbursement
could affect the adoption of the System One.
Our ability to attain profitability will be driven in part by
our ability to set or maintain adequate pricing for our System
One. As a result of legislation passed by the U.S. Congress
more than 30 years ago, Medicare provides comprehensive and
well-established reimbursement in the United States for ESRD.
With over 80% of U.S. ESRD patients covered by Medicare,
the reimbursement rate is an important factor in a potential
customers decision to use the System One and limits the
fee for which we can rent the System One and sell the related
disposable cartridges and treatment fluids. Current CMS rules
limit the number of hemodialysis treatments paid for by Medicare
to three times a week, unless there is medical justification for
additional treatments. Most patients using the System One in the
home treat themselves, with the help of a partner, up to six
times per week. To the extent that Medicare contractors elect
not to pay for the additional treatments, adoption of the System
One may be slowed. Changes in Medicare reimbursement rates could
negatively affect demand for our products and the prices we
charge for them.
As we
continue to commercialize the System One and related products,
we may have difficulty managing our growth and expanding our
operations successfully.
As the commercial launch of the System One continues, we will
need to expand our regulatory, manufacturing, sales and
marketing and on-going development capabilities or contract with
other organizations to provide these capabilities for us. As our
operations expand, we expect that we will need to manage
additional relationships with various partners, suppliers,
manufacturers and other organizations. Our ability to manage our
operations and growth requires us to continue to improve our
operational, financial and management controls and reporting
systems and procedures. Such growth could place a strain on our
administrative and operational infrastructure. We may not be
able to make improvements to our management information and
control systems in an efficient or timely manner and may
discover deficiencies in existing systems and controls.
If we
are unable to improve on the product reliability performance
typically experienced in the early stages of a products
life cycle, our ability to grow our business and achieve
profitability could be impaired.
Our System One is still early in its product launch, and our
PureFlow SL module was only introduced during the third quarter
of 2006. We continue to experience product reliability issues
that are higher than we expect long-term, which lead us to incur
increased service and distribution costs, as well as increase
the size of our field equipment base. This, in turn, negatively
impacts our gross margins and increases our working capital
requirements. Additionally, product reliability issues can also
lead to decreases in customer satisfaction and our ability to
grow or maintain our revenues. We continue to work to improve
product reliability, and have achieved some improvements to
date. If we are unable to continue to improve product
reliability, our ability to achieve our growth objectives as
well as profitability could be significantly impaired.
Most recently, in the second quarter of 2007, we started to
experience an increased incidence of reported dialysate leaks
associated with our System One cartridges. The reported
incidence of leaks is higher than we have historically observed.
When the System One is used in accordance with its instructions,
these leaks present no risk to patient health. System One device
labeling anticipates the potential for leaks to occur and
specifically warns against leaks and alerts users of the need to
observe treatments in order to detect leaks. Four patients with
reported leaks, that were unobserved by these patients or their
partners until after their treatments were terminated, reported
hypotension, or low blood pressure, resolved by a fluid bolus,
with no
23
lasting clinical effect. In early August 2007, we sent a letter
to our patients and customers informing them of the increased
incidence in leaks and reminding them of existing System One
labeling alerting users of the potential for leaks and
instructing them to observe treatments in order to detect any
leaks. We have characterized this notification as a voluntary
recall. On August 24, 2007, we elected to initiate a second
step in our recall actions, and decided to physically recall the
affected lots of cartridge inventory being held by chronic
market customers and patients, and replace the affected
inventory with newer lots of cartridges at no charge. We have
instructed patients and customers to destroy all inventory of
affected cartridges they have on hand, and we expect to
write-off up to all of the inventory of affected cartridges we
have in-house. It is possible that we may be able to rework this
cartridge inventory, or reuse certain components of this
inventory, but we have not made a final determination related to
this recovery.
Based on these facts, we determined on August 24, 2007 that
we would incur total charges in connection with this recall in
the range of $1.9 million to $2.5 million, the
principal component of which relates to the write-off of
inventory in the range of $1.8 million to
$2.2 million. Other charges primarily relate to increased
shipping for replacement product and cycler servicing costs.
Substantially all of these charges would be recorded in the
quarter ending September 30, 2007.
The increased incidence in leaks has also been associated with
increased cycler service requirements, which have led to
increased service costs as well as imposed additional service
pool requirements on our cycler inventory. In the short term,
this may impede our ability to meet customer demand.
We
have a significant amount of field equipment, and our ability to
effectively manage this asset could negatively impact our
working capital requirements and future
profitability.
Because the majority of our chronic care business continues to
rely upon an equipment rental model, our ability to manage
System One equipment is important to minimizing our working
capital requirements. In addition, our gross margins may be
negatively impacted if we have excess equipment deployed, and
unused, in the field. If we are unable to successfully track,
service and redeploy equipment, we could (1) incur
increased costs, (2) realize increased cash requirements
and/or
(3) have material write-offs of equipment.
Our
agreement with DaVita confers certain geographic market rights
to DaVita and limits our ability to sell the System One to
Fresenius, both of which may present a barrier to adoption of
the System One.
Fresenius and DaVita own and operate the two largest chains of
dialysis clinics in the United States. Fresenius controls
approximately 33% of the U.S. dialysis clinics and is the
largest worldwide manufacturer of dialysis systems. DaVita
controls approximately 27% of the U.S. dialysis clinics,
and has entered into a preferred supplier agreement with Gambro
pursuant to which Gambro will provide a significant majority of
DaVitas dialysis equipment and supplies for a period of at
least 10 years. Each of Fresenius and DaVita may choose to
offer their dialysis patients only the dialysis equipment
manufactured by them or their affiliates, to offer the equipment
they contractually agreed to offer or to otherwise limit access
to the equipment manufactured by competitors.
Our recent agreement with DaVita confers certain market rights
for the System One and related supplies for home hemodialysis
therapy. DaVita is granted exclusive rights in a small
percentage of geographies, which geographies collectively
represent less than 10% of the U.S. ESRD patient
population, and limited exclusivity in the majority of all other
U.S. geographies, subject to DaVitas meeting certain
requirements, including patient volume commitments and new
patient training rates. Under the agreement, we can continue to
sell to other clinics in the majority of geographies. If certain
minimum patient numbers or training rates are not achieved,
DaVita can lose all or part of its preferred geographic rights.
The agreement further limits, but does not prohibit, the sale by
NxStage of the System One for chronic home patient hemodialysis
therapy to any provider that is under common control or
management of a parent entity that collectively provides
dialysis services to more than 25% of U.S. chronic dialysis
patients and that also supplies dialysis products. Therefore,
24
our ability to sell the System One for chronic home patient
hemodialysis therapy to Fresenius is presently limited.
It is not yet clear what impact this agreement may have on the
market acceptance for our product. It is also not yet clear to
what extent DaVita will purchase the System One from us. For the
six months ended June 30, 2007, sales to DaVita represented
30% of our total revenues. Although we expect that DaVita will
continue to be a significant customer of ours, the agreement
imposes no purchase obligations upon DaVita and we cannot be
certain whether DaVita will continue to purchase
and/or rent
the System One from us in the future. We believe that any future
decision by DaVita to stop or limit the use of the System One
would adversely affect our business, at least in the near term.
If
kidney transplantation becomes a viable treatment option for
more patients with ESRD, the market for our System One may be
limited.
While kidney transplantation is the treatment of choice for most
ESRD patients, it is not currently a viable treatment for most
patients due to the limited number of donor kidneys, the high
incidence of kidney transplant rejection and the higher surgical
risk associated with older ESRD patients. According to the most
recent USRDS data, in 2004 approximately 17,000 patients
received kidney transplants in the United States. The
development of new medications designed to reduce the incidence
of kidney transplant rejection, progress in using kidneys
harvested from genetically engineered animals as a source of
transplants or any other advances in kidney transplantation
could limit the market for our System One.
If we
are unable to convince hospitals and healthcare providers of the
benefits of our products for the treatment of acute kidney
failure and fluid overload, we may not be successful in
penetrating the critical care market.
We sell the System One for use in the treatment of acute kidney
failure and fluid overload associated with, among other
conditions, congestive heart failure. Physicians currently treat
most acute kidney failure patients using conventional
hemodialysis systems or dialysis systems designed specifically
for use in the ICU. We will need to convince hospitals and
healthcare providers that using the System One is as effective
as using conventional hemodialysis systems or ICU specific
dialysis systems for treating acute kidney failure and that it
provides advantages over conventional systems or other ICU
specific systems because of its significantly smaller size and
ease of operation.
We are
subject to the risk of costly and damaging product liability
claims and may not be able to maintain sufficient product
liability insurance to cover claims against us.
If our System One is found to have caused or contributed to
injuries or deaths, we could be held liable for substantial
damages. Claims of this nature may also adversely affect our
reputation, which could damage our position in the market. As is
the case with a number of other medical device companies, it is
likely that product liability claims will be brought against us.
Since their introduction into the market, our products have been
subject to three voluntary recalls and one voluntary product
withdrawal. Our first voluntary recall occurred in February 2001
in Canada and related to a software glitch that we detected in
our predecessor system, which could have increased the
likelihood of a clotted filter during treatment. There were no
patient injuries associated with this recall, and the software
glitch was remedied with a subsequent software release. The
second voluntary recall occurred in April 2004 in the United
States relating to pinhole-sized dialysate leaks in our
cartridges. Although System One device labeling anticipates the
potential for leaks to occur, and therefore specifically warns
against leaks and alerts users of the need to check for leaks
while performing treatments, the incidence of leaks was higher
than we had historically experienced. There were no patient
injuries associated with this recall; we subsequently switched
suppliers and instituted additional testing requirements to
minimize the chance for pinhole-sized leaks in our cartridges.
Our third voluntary recall occurred in the United Sates in
August 2007 and also related to pinhole-sized leaks in our
cartridges. Four patients with reported leaks, that were
unobserved by these patients or their partners until the end of
their treatments, reported hypotension, or low blood pressure,
resolved by a fluid bolus, with no lasting clinical effect. No
other patient injuries were reported in connection with this
recall. In response to this increased
25
incidence in leaks, we are developing tests to better evaluate
the susceptibility of cartridges to leaks prior to release, with
the goal of reducing the chance for pinhole-sized leaks in our
cartridges. The voluntary market withdrawal occurred in the
United States in May 2002 when we suspended sales of our
predecessor system while we addressed issues involving limited
instances of contaminated hemofiltration fluids compounded by a
pharmacy and supplied by a third-party. Six patients exposed to
contaminated fluids reported fevers
and/or
chills, with no lasting clinical effect. We subsequently
modified our cartridge to allow for an additional filter to
remove contaminants from fluids used with our product. Our
products may be subject to further recalls or withdrawals, which
could increase the likelihood of product liability claims. We
have also received several reports of operator error from both
patients in the home hemodialysis setting and nurses in the
critical care setting. We have sought to address many potential
sources of operator error with product design changes to
simplify the operator process. In addition, we have made
improvements in our training materials and product labeling.
However, instances of operator error cannot be eliminated and
could also increase the likelihood of product liability claims.
Although we maintain insurance, including product liability
insurance, we cannot provide assurance that any claim that may
be brought against us will not result in court judgments or
settlements in amounts that are in excess of the limits of our
insurance coverage. Our insurance policies also have various
exclusions, and we may be subject to a product liability claim
for which we have no coverage. We will have to pay any amounts
awarded by a court or negotiated in a settlement that exceed our
coverage limitations or that are not covered by our insurance.
Any product liability claim brought against us, with or without
merit, could result in the increase of our product liability
insurance rates or the inability to secure additional insurance
coverage in the future. A product liability claim, whether
meritorious or not, could be time consuming, distracting and
expensive to defend and could result in a diversion of
management and financial resources away from our primary
business, in which case our business may suffer.
We
maintain insurance at levels deemed adequate by management,
however, future claims could exceed our applicable insurance
coverage.
We maintain insurance for property and general liability,
directors and officers liability, workers
compensation, and other coverage in amounts and on terms deemed
adequate by management based on our expectations for future
claims. Future claims could, however, exceed our applicable
insurance coverage, or our coverage could not cover the
applicable claims.
We
have had limited sales, marketing, customer service and
distribution experience. We need to expand our sales and
marketing, customer service and distribution infrastructures to
be successful in penetrating the dialysis market.
We currently market and sell the System One through our own
sales force, and we have had limited experience in sales,
marketing and distribution of dialysis products. As of
July 31, 2007, we had 113 employees in our sales,
marketing and distribution organization, including 31 direct
sales representatives. We plan to expand our sales, marketing,
customer service and distribution infrastructures. We cannot
provide assurance that we will be able to retain or attract
experienced personnel to our early-stage company and build an
adequate sales and marketing, customer service and distribution
staff or that the cost will not be prohibitive.
We
face risks associated with having international manufacturing
operations, and if we are unable to manage these risks
effectively, our business could suffer.
In addition to our operations in Lawrence, Massachusetts, we
operate manufacturing facilities in Rosdorf, Germany and
Fresnillo, Mexico and we purchase components and supplies from
foreign vendors. We are subject to a number of risks and
challenges that specifically relate to these international
operations, and we may not be successful if we are unable to
meet and overcome these challenges. These risks include
fluctuations in foreign currency exchange rates that may
increase the U.S. dollar cost of the disposables we
purchase from foreign third-party suppliers, costs associated
with sourcing and shipping goods internationally,
26
difficulty managing operations in multiple locations and local
regulations that may restrict or impair our ability to conduct
our operations.
Risks
Related to the Proposed Acquisition of the Medisystems Entities
and Other Possible Business Combinations
We may
not complete the acquisition of the Medisystems entities and,
the failure to do so, could harm our common stock price and
future business and operations.
On June 4, 2007, we entered into a stock purchase agreement
with David S. Utterberg to purchase his issued and outstanding
shares of Medisystems Services Corporation, a Nevada
corporation, Medisystems Corporation, a Washington corporation,
Medisystems Europe S.p.A., a company organized under the laws of
Italy, and Medimexico s. de R.L. de C.V., a company organized
under the laws of Mexico, which we refer to collectively as the
Medisystems entities. The proposed acquisition of the
Medisystems entities is subject to a number of closing
conditions, including approval of our stockholders, and may not
be completed. If the acquisition is not completed, we may be
subject to the following risks:
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the price of our common stock may decline;
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we will not realize our expected benefits of the acquisition;
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under certain circumstances we will be required to pay
Mr. Utterberg a termination fee of up to $600,000 in
reasonable documented expenses incurred by him in connection
with the acquisition; and
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the costs incurred by us related to the acquisition, such as
legal, accounting and certain financial advisory fees, must be
paid even if the acquisition is not completed.
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The
market price of our common stock may decline as a result of the
acquisition.
The market price of our common stock may decline as a result of
the acquisition for a number of reasons including if:
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we do not achieve the perceived benefits of the acquisition as
rapidly or to the extent anticipated by financial or industry
analysts;
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the effect of the acquisition on our business and prospects is
not consistent with the expectations of financial or industry
analysts; or
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investors react negatively to the effect on our business and
prospects from the acquisition.
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Our
stockholders may not realize a benefit from the acquisition
commensurate with the ownership dilution they will experience in
connection with the acquisition.
As consideration for the acquisition of the Medisystems
entities, we expect to issue 6,500,000 shares of our common
stock, or approximately 21.7% of our outstanding common stock as
of July 31, 2007. If we are unable to realize the strategic
and financial benefits currently anticipated from the
acquisition, our stockholders will have experienced substantial
dilution of their ownership interest without receiving
commensurate benefit.
We may
face challenges in integrating Medisystems business with
NxStages and, as a result, may not realize the expected
benefits of the proposed acquisition.
Even though NxStages and Medisystems businesses are
relatively distinct, integrating the operations and personnel of
Medisystems and NxStage will require a significant investment of
managements time and effort as well as the investment of
capital, particularly with respect to information systems. The
successful integration of Medisystems and NxStage will require,
among other things, coordination of certain manufacturing
operations and sales and marketing operations and the
integration of Medisystems operations into the NxStage
organization. The diversion of the attention of NxStages
and Medisystems senior management and any difficulties
encountered in the process of combining the companies could
cause the disruption of, or a loss of momentum in, the
activities of the combined businesses.
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The inability to successfully integrate the operations and
personnel of Medisystems and NxStage, or any significant delay
in achieving integration, could have a material adverse effect
on the combined businesses after the completion of the
acquisition, and, as a result, on the market price of
NxStages common stock.
We may
grow through additional acquisitions, which could dilute our
existing shareholders and could involve substantial integration
risks.
As part of our business strategy, we may acquire, in addition to
our proposed acquisition of Medisystems, other businesses and
technologies in the future. We may issue equity securities as
consideration for future acquisitions that would dilute our
existing stockholders, perhaps significantly depending on the
terms of the acquisition. We may also incur additional debt in
connection with future acquisitions, which, if available at all,
may place additional restrictions on our ability to operate our
business. Acquisitions may involve a number of risks, including:
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difficulty in transitioning and integrating the operations and
personnel of the acquired businesses, including different and
complex accounting and financial reporting systems;
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potential disruption of our ongoing business and distraction of
management;
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potential difficulty in successfully implementing, upgrading and
deploying in a timely and effective manner new operational
information systems and upgrades of our finance, accounting and
product distribution systems;
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difficulty in incorporating acquired technology and rights into
our products and technology;
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unanticipated expenses and delays in completing acquired
development projects and technology integration;
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management of geographically remote units both in the United
States and internationally;
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impairment of relationships with partners and customers;
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customers delaying purchases of our products pending resolution
of product integration between our existing and our newly
acquired products;
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entering markets or types of businesses in which we have limited
experience; and
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potential loss of key employees of the acquired company;
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Inaccurate assumptions of acquired companys product
quality
and/or
product reliability.
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As a result of these and other risks, we may not realize
anticipated benefits from our acquisitions. Any failure to
achieve these benefits or failure to successfully integrate
acquired businesses and technologies could seriously harm our
business.
Purchase
accounting treatment of acquisitions could decrease our net
income in the foreseeable future, which could have a material
and adverse effect on the market value of our common
stock.
Under accounting principles generally accepted in the United
States of America, we would account for acquisitions using the
purchase method of accounting. Under purchase accounting, we
would record the consideration issued in connection with the
acquisition and the amount of direct transaction costs as the
cost of acquiring the company or business. We would allocate
that cost to the individual assets acquired and liabilities
assumed, including various identifiable intangible assets such
as acquired technology, acquired trade names and acquired
customer relationships based on their respective fair values.
Intangible assets generally will be amortized over a three to
fifteen year period. Goodwill and certain intangible assets with
indefinite lives are not subject to amortization but are subject
to at least an annual impairment analysis, which may result in
an impairment charge if the carrying value exceeds their implied
fair value. These potential future amortization and impairment
charges may significantly reduce net income, if any, and
therefore may adversely affect the market value of our common
stock.
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Risks
Related to the Regulatory Environment
We are
subject to significant regulation, primarily by the FDA. We
cannot market or commercially distribute our products without
obtaining and maintaining necessary regulatory clearances or
approvals.
Our System One and related products, including the disposables
required for its use, are all medical devices subject to
extensive regulation in the United States, and in foreign
markets we may wish to enter. To market a medical device in the
United States, approval or clearance by the FDA is required,
either through the pre-market approval process or the 510(k)
clearance process. We have obtained the FDA clearances necessary
to sell our current products under the 510(k) clearance process.
Medical devices may only be promoted and sold for the
indications for which they are approved or cleared. In addition,
even if the FDA has approved or cleared a product, it can take
action affecting such product approvals or clearances if serious
safety or other problems develop in the marketplace. We may be
required to obtain 510(k) clearances or pre-market approvals for
additional products, product modifications, or for new
indications for the System One. We cannot provide assurance that
such clearances or approvals would be forthcoming, or, if
forthcoming, what the timing and expense of obtaining such
clearances or approvals might be. Delays in obtaining clearances
or approvals could adversely affect our ability to introduce new
products or modifications to our existing products in a timely
manner, which would delay or prevent commercial sales of our
products.
Modifications
to our marketed devices may require new regulatory clearances or
pre-market approvals, or may require us to cease marketing or
recall the modified devices until clearances or approvals are
obtained.
Any modifications to a 510(k) cleared device that could
significantly affect its safety or effectiveness, or would
constitute a major change in its intended use, requires the
submission of another 510(k) pre-market notification to address
the change. Although in the first instance we may determine that
a change does not rise to a level of significance that would
require us to make a pre-market notification submission, the FDA
may disagree with us and can require us to submit a 510(k) for a
significant change in the labeling, technology, performance
specifications or materials or major change or modification in
intended use, despite a documented rationale for not submitting
a pre-market notification. We have modified various aspects of
the System One and have filed and received clearance from the
FDA with respect to some of the changes in the design of our
products. If the FDA requires us to submit a 510(k) for any
modification to a previously cleared device, or in the future a
device that has received 510(k) clearance, we may be required to
cease marketing the device, recall it, and not resume marketing
until we obtain clearance from the FDA for the modified version
of the device. Also, we may be subject to regulatory fines,
penalties
and/or other
sanctions authorized by the Federal Food, Drug, and Cosmetic
Act. In the future, we intend to introduce new products and
enhancements and improvements to existing products. We cannot
provide assurance that the FDA will clear any new product or
product changes for marketing or what the timing of such
clearances might be. In addition, new products or significantly
modified marketed products could be found to be not
substantially equivalent and classified as products requiring
the FDAs approval of a pre-market approval application, or
PMA, before commercial distribution would be permissible. PMAs
usually require substantially more data than 510(k) submissions
and their review and approval or denial typically takes
significantly longer than a 510(k) decision of substantial
equivalence. Also, PMA products require approval supplements for
any change that affects safety and effectiveness before the
modified device may be marketed. Delays in our receipt of
regulatory clearance or approval will cause delays in our
ability to sell our products, which will have a negative effect
on our revenues growth.
Even
if we obtain the necessary FDA clearances or approvals, if we or
our suppliers fail to comply with ongoing regulatory
requirements our products could be subject to restrictions or
withdrawal from the market.
We are subject to the Medical Device Reporting, or MDR,
regulations that require us to report to the FDA if our products
may have caused or contributed to patient death or serious
injury, or if our device malfunctions and a recurrence of the
malfunction would likely result in a death or serious injury. We
must also file reports of device corrections and removals and
adhere to the FDAs rules on labeling and promotion.
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Our failure to comply with these or other applicable regulatory
requirements could result in enforcement action by the FDA,
which may include any of the following:
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untitled letters, warning letters, fines, injunctions and civil
penalties;
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administrative detention, which is the detention by the FDA of
medical devices believed to be adulterated or misbranded;
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customer notification, or orders for repair, replacement or
refund;
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voluntary or mandatory recall or seizure of our products;
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operating restrictions, partial suspension or total shutdown of
production;
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refusal to review pre-market notification or pre-market approval
submissions;
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rescission of a substantial equivalence order or suspension or
withdrawal of a pre-market approval; and
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criminal prosecution.
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Our
products are subject to market withdrawals or product recalls
after receiving FDA clearance or approval, and market
withdrawals and product recalls could cause the price of our
stock to decline and expose us to product liability or other
claims or could otherwise harm our reputation and financial
results.
Complex medical devices, such as the System One, can experience
performance problems in the field that require review and
possible corrective action by us or the product manufacturer. We
cannot provide assurance that component failures, manufacturing
errors, design defects
and/or
labeling inadequacies, which could result in an unsafe condition
or injury to the operator or the patient will not occur. These
could lead to a government mandated or voluntary recall by us.
The FDA has the authority to require the recall of our products
in the event a product presents a reasonable probability that it
would cause serious adverse health consequences or death.
Similar regulatory agencies in other countries have similar
authority to recall devices because of material deficiencies or
defects in design or manufacture that could endanger health. We
believe that the FDA would request that we initiate a voluntary
recall if a product was defective or presented a risk of injury
or gross deception. Any recall could divert management attention
and financial resources, could cause the price of our stock to
decline and expose us to product liability or other claims and
harm our reputation with customers. Recalls, involving the
System One, depending upon the nature and scope of the recall,
may be particularly harmful to our business and financial
results, because the System One is our primary product. We will
incur costs in connection with our August 2007 voluntary recall
relating to the increased incidence of reported cartridge leaks
in the range of $1.9 million to $2.5 million,
primarily associated with the write-off of affected inventory.
The leaks associated with this recall have also led to customer
dissatisfaction which, in the short term, could impair our
future growth.
If we
or our contract manufacturers fail to comply with FDAs
Quality System regulations, our manufacturing operations could
be interrupted, and our product sales and operating results
could suffer.
Our finished goods manufacturing processes, and those of some of
our contract manufacturers, are required to comply with the
FDAs Quality System regulations, or QSRs, which cover the
procedures and documentation of the design, testing, production,
control, quality assurance, labeling, packaging, sterilization,
storage and shipping of our devices. The FDA enforces its QSRs
through periodic unannounced inspections of manufacturing
facilities. We and our contract manufacturers have been, and
anticipate in the future being, subject to such inspections. Our
U.S. manufacturing facility has previously had three FDA
QSR inspections. The first resulted in one observation, which
was rectified during the inspection and required no further
response from us. Our last two inspections, including our most
recent inspection in March 2006, resulted in no observations. We
cannot provide assurance that any future inspections would have
the same result. If one of our manufacturing facilities or those
of any of our contract manufacturers fails to take satisfactory
corrective action in response to an adverse QSR inspection, FDA
could take enforcement action, including issuing a public
warning letter, shutting down our manufacturing operations,
embargoing the import of components from
30
outside of the United States, recalling our products, refusing
to approve new marketing applications, instituting legal
proceedings to detain or seize products or imposing civil or
criminal penalties or other sanctions, any of which could cause
our business and operating results to suffer.
Changes
in reimbursement for treatment for ESRD could affect the
adoption of our System One and the level of our future product
revenues.
In the United States, all patients who suffer from ESRD,
regardless of age, are eligible for coverage under Medicare,
after a requisite coordination period if other insurance is
available. As a result, more than 80% of patients with ESRD are
covered by Medicare. Although we rent and sell our products to
hospitals, dialysis centers and other healthcare providers and
not directly to patients, the reimbursement rate for ESRD
treatments is an important factor in a potential customers
decision to purchase the System One. The dialysis centers that
purchase our product rely on adequate third-party payor coverage
and reimbursement to maintain their ESRD facilities. The CMS
provides the composite rate for dialysis services, which is
subject to regional variation and varies depending upon whether
the facility is hospital-based or an independent clinic. The
composite rate is intended to cover most items and services
related to the treatment of ESRD, but does not include payment
for physician services or separately billable laboratory
services or drugs. Changes in Medicare reimbursement rates could
negatively affect demand for our products and the prices we
charge for them.
Most ESRD patients who use our product for dialysis therapy in
the home treat themselves six times per week. CMS rules,
however, limit the number of hemodialysis treatments paid for by
Medicare to three a week, unless there is medical justification
for the additional treatments. The determination of medical
justification must be made at the local Medicare contractor
level on a
case-by-case
basis. If daily therapy is prescribed, a clinics decision
as to how much it is willing to spend on dialysis equipment and
services will be at least partly dependent on whether Medicare
will reimburse more than three treatments per week for the
clinics patients.
Unlike Medicare reimbursement for ESRD, Medicare only reimburses
healthcare providers for acute kidney failure and fluid overload
treatment if the patient is otherwise eligible for Medicare,
based on age or disability. Medicare and many other third-party
payors and private insurers reimburse these treatments provided
to hospital inpatients under a traditional DRG system. Under
this system, reimbursement is determined based on a
patients primary diagnosis and is intended to cover all
costs of treating the patient. The presence of acute kidney
failure or fluid overload increases the severity of the primary
diagnosis and, accordingly, may increase the amount reimbursed.
For care of these patients to be cost-effective, hospitals must
manage the longer hospitalization stays and significantly more
nursing time typically necessary for patients with acute kidney
failure and fluid overload. If we are unable to convince
hospitals that our System One provides a cost-effective
treatment alternative under this diagnosis related group
reimbursement system, they may not purchase our product. In
addition, changes in Medicare reimbursement rates for hospitals
could negatively affect demand for our products and the prices
we charge for them.
Legislative
or regulatory reform of the healthcare system may affect our
ability to sell our products profitably.
In both the United States and foreign countries, there have been
legislative and regulatory proposals to change the healthcare
system in ways that could affect our ability to sell our
products profitably. The federal government and some states have
enacted healthcare reform legislation, and further federal and
state proposals are likely. We cannot predict the exact form
this legislation may take, the probability of passage, or the
ultimate effect on us. Our business could be adversely affected
by future healthcare reforms or changes in Medicare.
Failure
to obtain regulatory approval in foreign jurisdictions would
prevent us from marketing our products outside the United
States.
Although we have not initiated any marketing efforts in
jurisdictions outside of the United States and Canada, we intend
in the future to market our products in other markets. In order
to market our products in the European
31
Union or other foreign jurisdictions, we must obtain separate
regulatory approvals and comply with numerous and varying
regulatory requirements. The approval procedure varies from
country to country and can involve additional testing. The time
required to obtain approval abroad may be longer than the time
required to obtain FDA clearance. The foreign regulatory
approval process includes many of the risks associated with
obtaining FDA clearance and we may not obtain foreign regulatory
approvals on a timely basis, if at all. FDA clearance does not
ensure approval by regulatory authorities in other countries,
and approval by one foreign regulatory authority does not ensure
approval by regulatory authorities in other foreign countries.
We may not be able to file for regulatory approvals and may not
receive necessary approvals to commercialize our products in any
market outside the United States, which could negatively effect
our overall market penetration.
We
currently have obligations under our contracts with dialysis
clinics and hospitals to protect the privacy of patient health
information.
In the course of performing our business we obtain, from time to
time, confidential patient health information. For example, we
learn patient names and addresses when we ship our System One
supplies to home hemodialysis patients. We may learn patient
names and be exposed to confidential patient health information
when we provide training on System One operations to our
customers staff. Our home hemodialysis patients may also
call our customer service representatives directly and, during
the call, disclose confidential patient health information.
U.S. Federal and state laws protect the confidentiality of
certain patient health information, in particular individually
identifiable information, and restrict the use and disclosure of
that information. At the federal level, the Department of Health
and Human Services promulgated health information and privacy
and security rules under the Health Insurance Portability and
Accountability Act of 1996, or HIPAA. At this time, we are not a
HIPAA covered entity and consequently are not directly subject
to HIPAA. However, we have entered into several business
associate agreements with covered entities that contain
commitments to protect the privacy and security of
patients health information and, in some instances,
require that we indemnify the covered entity for any claim,
liability, damage, cost or expense arising out of or in
connection with a breach of the agreement by us. If we were to
violate one of these agreements, we could lose customers and be
exposed to liability
and/or our
reputation and business could be harmed. In addition, conduct by
a person that is not a covered entity could potentially be
prosecuted under aiding and abetting or conspiracy laws if there
is an improper disclosure or misuse of patient information.
Many state laws apply to the use and disclosure of health
information, which could affect the manner in which we conduct
our business. Such laws are not necessarily preempted by HIPAA,
in particular those laws that afford greater protection to the
individual than does HIPAA. Such state laws typically have their
own penalty provisions, which could be applied in the event of
an unlawful action affecting health information.
We are
subject to federal and state laws prohibiting
kickbacks and false and fraudulent claims which, if
violated, could subject us to substantial penalties.
Additionally, any challenges to or investigation into our
practices under these laws could cause adverse publicity and be
costly to respond to, and thus could harm our
business.
The Medicare/ Medicaid anti-kickback laws, and several similar
state laws, prohibit payments that are intended to induce
physicians or others either to refer patients or to acquire or
arrange for or recommend the acquisition of healthcare products
or services. These laws affect our sales, marketing and other
promotional activities by limiting the kinds of financial
arrangements, including sales programs, we may have with
hospitals, physicians or other potential purchasers or users of
medical devices. In particular, these laws influence, among
other things, how we structure our sales and rental offerings,
including discount practices, customer support, education and
training programs and physician consulting and other service
arrangements. Although we seek to structure such arrangements in
compliance with applicable requirements, these laws are broadly
written, and it is often difficult to determine precisely how
these laws will be applied in specific circumstances. If one of
our sales representatives were to offer an inappropriate
inducement to purchase our System One to a customer, we could be
subject to a claim under the Medicare/ Medicaid anti-kickback
laws.
Other federal and state laws generally prohibit individuals or
entities from knowingly presenting, or causing to be presented,
claims for payments from Medicare, Medicaid or other third-party
payors that are
32
false or fraudulent, or for items or services that were not
provided as claimed. Although we do not submit claims directly
to payors, manufacturers can be held liable under these laws if
they are deemed to cause the submission of false or
fraudulent claims by providing inaccurate billing or coding
information to customers, or through certain other activities.
In providing billing and coding information to customers, we
make every effort to ensure that the billing and coding
information furnished is accurate and that treating physicians
understand that they are responsible for all billing and
prescribing decisions, including the decision as to whether to
order dialysis services more frequently than three times per
week. Nevertheless, we cannot provide assurance that the
government will regard any billing errors that may be made as
inadvertent or that the government will not examine our role in
providing information to our customers concerning the benefits
of daily therapy. Anti-kickback and false claims laws prescribe
civil, criminal and administrative penalties for noncompliance,
which can be substantial. Moreover, an unsuccessful challenge or
investigation into our practices could cause adverse publicity,
and be costly to respond to, and thus could harm our business
and results of operations.
Foreign
governments tend to impose strict price controls, which may
adversely affect our future profitability.
Although we have not initiated any marketing efforts in
jurisdictions outside of the United States and Canada, we intend
in the future to market our products in other markets. In some
foreign countries, particularly in the European Union, the
pricing of medical devices is subject to governmental control.
In these countries, pricing negotiations with governmental
authorities can take considerable time after the receipt of
marketing approval for a product. To obtain reimbursement or
pricing approval in some countries, we may be required to supply
data that compares the cost-effectiveness of the System One to
other available therapies. If reimbursement of our products is
unavailable or limited in scope or amount, or if pricing is set
at unsatisfactory levels, it may not be profitable to sell our
products outside of the United States, which would negatively
affect the long-term growth of our business.
Our
business activities involve the use of hazardous materials,
which require compliance with environmental and occupational
safety laws regulating the use of such materials. If we violate
these laws, we could be subject to significant fines,
liabilities or other adverse consequences.
Our research and development programs as well as our
manufacturing operations involve the controlled use of hazardous
materials. Accordingly, we are subject to federal, state and
local laws governing the use, handling and disposal of these
materials. Although we believe that our safety procedures for
handling and disposing of these materials comply in all material
respects with the standards prescribed by state and federal
regulations, we cannot completely eliminate the risk of
accidental contamination or injury from these materials. In the
event of an accident or failure to comply with environmental
laws, we could be held liable for resulting damages, and any
such liability could exceed our insurance coverage.
Risks
Related to Operations
We
depend on the services of our senior executives and certain key
engineering, scientific, clinical and marketing personnel, the
loss of whom could negatively affect our business.
Our success depends upon the skills, experience and efforts of
our senior executives and other key personnel, including our
chief executive officer, certain members of our engineering
staff, our marketing executives and managers, our manufacturing
executives and managers and our clinical educators. Much of our
corporate expertise is concentrated in relatively few employees,
the loss of which for any reason could negatively affect our
business. Competition for our highly skilled employees is
intense and we cannot prevent the resignation of any employee.
Virtually all of our employees have agreements which impose
obligations that may prevent a former employee of ours from
working for a competitor for a period of time; however, these
clauses may not be enforceable, or enforceable only in part, or
the company may choose not to seek enforcement. We do not
maintain key man life insurance on any of our senior
executives, other than our chief executive officer.
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We
obtain some of the components, subassemblies and completed
products included in the System One from a single source or a
limited group of manufacturers or suppliers, and the partial or
complete loss of one of these manufacturers or suppliers could
cause significant production delays, an inability to meet
customer demand and a substantial loss in
revenues.
We depend on single source suppliers for some of the components
and subassemblies we use in the System One. KMC Systems, Inc. is
our only contract manufacturer of the System One cycler,
although we are considering a plan to develop alternative
manufacturing capabilities for this product; B. Braun
Medizintechnologie GmbH is our only supplier of
bicarbonate-based dialysate used with the System One; Membrana
GmbH is our only supplier of the fiber used in our filters; PISA
is our primary supplier of lactate-based dialysate; and
Medisystems Corporation is the only supplier of our disposable
cartridge and several cartridge components. Medisystems is a
related party to NxStage. David Utterberg, the chief executive
officer and sole stockholder of Medisystems, is a member of our
board of directors and, at June 30, 2007, held
approximately 6.7% of our common stock. We also obtain certain
other components included in the System One from other single
source suppliers or a limited group of suppliers. Our dependence
on single source suppliers of components, subassemblies and
finished goods exposes us to several risks, including
disruptions in supply, price increases, late deliveries, and an
inability to meet customer demand. This could lead to customer
dissatisfaction, damage to our reputation, or customers
switching to competitive products. Any interruption in supply
could be particularly damaging to our customers using the System
One to treat chronic ESRD and who need access to the System One
and related disposables.
Finding alternative sources for these components and
subassemblies would be difficult in many cases and may entail a
significant amount of time and disruption. In the case of B.
Braun, for bicarbonate, and Membrana, for fiber, we are
contractually prevented from obtaining an alternative source of
supply, except in certain limited instances. In the case of
Medisystems, we are contractually prevented from obtaining an
alternative source of supply for more than 10% of our North
American requirements, except in certain limited instances. In
the case of other suppliers, we would need to change the
components or subassemblies if we sourced them from an
alternative supplier. This, in turn, could require a redesign of
our System One and, potentially, further FDA clearance or
approval of any modification, thereby causing further costs and
delays.
Certain
of our products are recently developed or are transitioning to
other locations and we, and certain of our third party
manufacturers, have limited manufacturing experience with these
products.
We continue to develop new products and make improvements to
existing products. We are also expanding our manufacturing
capacity which requires us to relocate our manufacturing
operations to other locations. As such, we and certain of our
third party manufacturers, have limited manufacturing experience
with certain of our products, including key products such as the
PureFlow SL and related disposables. We are, therefore, more
exposed to risks relating to product quality and reliability
until the manufacturing processes for these new products mature.
We do
not have long-term supply contracts with many of our third-party
suppliers.
We purchase components and subassemblies from third-party
suppliers, including some of our single source suppliers,
through purchase orders and do not have long-term supply
contracts with many of these third-party suppliers. Many of our
third-party suppliers, therefore, are not obligated to perform
services or supply products to us for any specific period, in
any specific quantity or at any specific price, except as may be
provided in a particular purchase order.
We do not maintain large volumes of inventory from most of these
suppliers. If we inaccurately forecast demand for components or
subassemblies, our ability to manufacture and commercialize the
System One could be delayed and our competitive position and
reputation could be harmed. In addition, if we fail to
effectively manage our relationships with these suppliers, we
may be required to change suppliers which would be time
consuming and could lead to disruptions in product supply, which
could permanently impair our customer base and reputation.
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Risks
Related to Intellectual Property
If we
are unable to protect our intellectual property and prevent its
use by third parties, we will lose a significant competitive
advantage.
We rely on patent protection, as well as a combination of
copyright, trade secret and trademark laws to protect our
proprietary technology and prevent others from duplicating our
products. However, these means may afford only limited
protection and may not:
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prevent our competitors from duplicating our products;
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prevent our competitors from gaining access to our proprietary
information and technology; or
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permit us to gain or maintain a competitive advantage.
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Any of our patents may be challenged, invalidated, circumvented
or rendered unenforceable. We cannot provide assurance that we
will be successful should one or more of our patents be
challenged for any reason. If our patent claims are rendered
invalid or unenforceable, or narrowed in scope, the patent
coverage afforded our products could be impaired, which could
make our products less competitive.
As of June 30, 2007, we had 48 pending patent applications,
including foreign, international and U.S. applications, and
27 U.S. and international issued patents. We cannot specify
which of these patents individually or as a group will permit us
to gain or maintain a competitive advantage. We cannot provide
assurance that any pending or future patent applications we hold
will result in an issued patent or that if patents are issued to
us, that such patents will provide meaningful protection against
competitors or against competitive technologies. The issuance of
a patent is not conclusive as to its validity or enforceability.
The United States federal courts or equivalent national courts
or patent offices elsewhere may invalidate our patents or find
them unenforceable. Competitors may also be able to design
around our patents. Our patents and patent applications cover
particular aspects of our products. Other parties may develop
and obtain patent protection for more effective technologies,
designs or methods for treating kidney failure. If these
developments were to occur, it would likely have an adverse
effect on our sales.
The laws of foreign countries may not protect our intellectual
property rights effectively or to the same extent as the laws of
the United States. If our intellectual property rights are not
adequately protected, we may not be able to commercialize our
technologies, products or services and our competitors could
commercialize similar technologies, which could result in a
decrease in our revenues and market share.
Our
products could infringe the intellectual property rights of
others, which may lead to litigation that could itself be
costly, could result in the payment of substantial damages or
royalties, and/or prevent us from using technology that is
essential to our products.
The medical device industry in general has been characterized by
extensive litigation and administrative proceedings regarding
patent infringement and intellectual property rights. Products
to provide kidney replacement therapy have been available in the
market for more than 30 years and our competitors hold a
significant number of patents relating to kidney replacement
devices, therapies, products and supplies. Although no third
party has threatened or alleged that our products or methods
infringe their patents or other intellectual property rights, we
cannot provide assurance that our products or methods do not
infringe the patents or other intellectual property rights of
third parties. If our business is successful, the possibility
may increase that others will assert infringement claims against
us.
Infringement and other intellectual property claims and
proceedings brought against us, whether successful or not, could
result in substantial costs and harm to our reputation. Such
claims and proceedings can also distract and divert management
and key personnel from other tasks important to the success of
the business. In addition, intellectual property litigation or
claims could force us to do one or more of the following:
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cease selling or using any of our products that incorporate the
asserted intellectual property, which would adversely affect our
revenues;
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pay substantial damages for past use of the asserted
intellectual property;
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obtain a license from the holder of the asserted intellectual
property, which license may not be available on reasonable
terms, if at all and which could reduce profitability; and
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redesign or rename, in the case of trademark claims, our
products to avoid infringing the intellectual property rights of
third parties, which may not be possible and could be costly and
time-consuming if it is possible to do so.
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Confidentiality
agreements with employees and others may not adequately prevent
disclosure of trade secrets and other proprietary
information.
In order to protect our proprietary technology and processes, we
also rely in part on confidentiality agreements with our
corporate partners, employees, consultants, outside scientific
collaborators and sponsored researchers, advisors and others.
These agreements may not effectively prevent disclosure of
confidential information and trade secrets and may not provide
an adequate remedy in the event of unauthorized disclosure of
confidential information. In addition, others may independently
discover or reverse engineer trade secrets and proprietary
information, and in such cases we could not assert any trade
secret rights against such party. Costly and time consuming
litigation could be necessary to enforce and determine the scope
of our proprietary rights, and failure to obtain or maintain
trade secret protection could adversely affect our competitive
position.
We may
be subject to damages resulting from claims that our employees
or we have wrongfully used or disclosed alleged trade secrets of
other companies.
Many of our employees were previously employed at other medical
device companies focused on the development of dialysis
products, including our competitors. Although no claims against
us are currently pending, we may be subject to claims that these
employees or we have inadvertently or otherwise used or
disclosed trade secrets or other proprietary information of
their former employers. Litigation may be necessary to defend
against these claims. If we fail in defending such claims, in
addition to paying monetary damages, we may lose valuable
intellectual property rights. Even if we are successful in
defending against these claims, litigation could result in
substantial costs, damage to our reputation and be a distraction
to management.
Risks
Related to our Common Stock
Our
stock price is likely to be volatile, and the market price of
our common stock may drop.
The market price of our common stock could be subject to
significant fluctuations. Market prices for securities of early
stage companies have historically been particularly volatile. As
a result of this volatility, you may not be able to sell your
common stock at or above the price you paid for the stock. Some
of the factors that may cause the market price of our common
stock to fluctuate include:
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timing of market acceptance of our products;
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timing of achieving profitability and positive cash flow from
operations;
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changes in estimates of our financial results or recommendations
by securities analysts or the failure to meet or exceed
securities analysts expectations;
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actual or anticipated variations in our quarterly operating
results;
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disruptions in product supply for any reason, including product
recalls of the failure of third party suppliers to needed
products or components;
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reports by officials or health or medical authorities, the
general media or the FDA regarding the potential benefits of the
System One or of similar dialysis products distributed by other
companies or of daily or home dialysis;
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announcements by the FDA of non-clearance or non-approval of our
products, or delays in the FDA or other foreign regulatory
agency review process;
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product recalls;
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regulatory developments in the United States and foreign
countries;
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changes in third-party healthcare reimbursements, particularly a
decline in the level of Medicare reimbursement for dialysis
treatments;
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litigation involving our company or our general industry or both;
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announcements of technical innovations or new products by us or
our competitors;
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developments or disputes concerning our patents or other
proprietary rights;
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our ability to manufacture and supply our products to commercial
standards;
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significant acquisitions, strategic partnerships, joint ventures
or capital commitments by us or our competitors;
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departures of key personnel; and
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investors general perception of our company, our products,
the economy and general market conditions.
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The stock markets in general have experienced substantial
volatility that has often been unrelated to the operating
performance of individual companies. These broad market
fluctuations may adversely affect the trading price of our
common stock.
In the past, following periods of volatility in the market price
of a companys securities, stockholders have often
instituted class action securities litigation against those
companies. Such litigation, if instituted, could result in
substantial costs and diversion of management attention and
resources, which could significantly harm our profitability and
reputation.
Anti-takeover
provisions in our restated certificate of incorporation and
amended and restated bylaws and under Delaware law could make an
acquisition of us more difficult and may prevent attempts by our
stockholders to replace or remove our current
management.
Provisions in our restated certificate of incorporation and our
amended and restated bylaws may delay or prevent an acquisition
of us. In addition, these provisions may frustrate or prevent
attempts by our stockholders to replace or remove members of our
board of directors. Because our board of directors is
responsible for appointing the members of our management team,
these provisions could in turn affect any attempt by our
stockholders to replace current members of our management team.
These provisions include:
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a prohibition on actions by our stockholders by written consent;
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the ability of our board of directors to issue preferred stock
without stockholder approval, which could be used to institute a
poison pill that would work to dilute the stock
ownership of a potential hostile acquirer, effectively
preventing acquisitions that have not been approved by our board
of directors;
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advance notice requirements for nominations of directors or
stockholder proposals; and
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the requirement that board vacancies be filled by a majority of
our directors then in office.
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In addition, because we are incorporated in Delaware, we are
governed by the provisions of Section 203 of the Delaware
General Corporation Law, which prohibits a person who owns in
excess of 15% of our outstanding voting stock from merging or
combining with us for a period of three years after the date of
the transaction in which the person acquired in excess of 15% of
our outstanding voting stock, unless the merger or combination
is approved in a prescribed manner. These provisions would apply
even if the offer may be considered beneficial by some
stockholders.
37
If
there are substantial sales of our common stock in the market by
our existing stockholders, our stock price could
decline.
If our existing stockholders sell a large number of shares of
our common stock or the public market perceives that existing
stockholders might sell shares of common stock, the market price
of our common stock could decline significantly. We have
29,995,126 shares of common stock outstanding as of
July 31, 2007. Shares held by our affiliates may only be
sold in compliance with the volume limitations of Rule 144.
These volume limitations restrict the number of shares that may
be sold by an affiliate in any three-month period to the greater
of 1% of the number of shares then outstanding, which
approximates 299,951 shares, or the average weekly trading
volume of our common stock during the four calendar weeks
preceding the filing of a notice on Form 144 with respect
to the sale.
At July 31, 2007, subject to certain conditions, holders of
an aggregate of approximately 13,511,174 shares of common
stock have rights with respect to the registration of these
shares of common stock with the SEC. We have agreed that
following the Stock Purchase, Mr. Utterberg will have
piggyback registration rights which means if we
propose to register shares of our common stock,
Mr. Utterberg will have the opportunity to include the
shares he received in the Stock Purchase in the registration. In
addition, we have agreed to register for resale the shares
issued to Mr. Utterberg as consideration for the Stock
Purchase in the event that, prior to the time this holding
period under rule 144(k) lapses as to such shares, he
ceases to be an affiliate of NxStage. If we register any of
these shares of common stock, they can be sold in the public
market without regard to the volume limitations of Rule 144.
As of July 31, 2007, 3,204,801 shares of common stock
are authorized for issuance under our stock incentive plan,
employee stock purchase plan and outstanding stock options. As
of July 31, 2007, 3,155,323 shares were subject to
outstanding options, of which 2,078,502 were exercisable and can
be freely sold in the public market upon issuance, subject to
the restrictions imposed on our affiliates under Rule 144.
Our
costs have increased significantly as a result of operating as a
public company, and our management is required to devote
substantial time to comply with public company
regulations.
As a public company, we incur significant legal, accounting and
other expenses that we did not incur as a private company. In
addition, the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley
Act, as well as new rules subsequently implemented by the SEC
and the NASDAQ Global Market, have imposed various new
requirements on public companies, including changes in corporate
governance practices. Our management and other personnel now
need to devote a substantial amount of time to these new
requirements. Moreover, these rules and regulations increase our
legal and financial compliance costs and make some activities
more time-consuming and costly.
In addition, the Sarbanes-Oxley Act requires, among other
things, that we maintain effective internal controls for
financial reporting and disclosure controls and procedures. In
particular, commencing in fiscal 2006, we must perform system
and process evaluation and testing of our internal controls over
financial reporting to allow management and our independent
registered public accounting firm to report on the effectiveness
of our internal controls over financial reporting, as required
by Section 404 of the Sarbanes-Oxley Act. Our compliance
with Section 404 will require that we incur substantial
accounting expense and expend significant management efforts. If
we are not able to comply with the requirements of
Section 404 in a timely manner, or if we or our independent
registered public accounting firm identify deficiencies in our
internal controls over financial reporting that are deemed to be
material weaknesses, the market price of our stock could decline
and we could be subject to sanctions or investigations by the
NASDAQ Global Market, SEC or other regulatory authorities.
We do
not anticipate paying cash dividends, and accordingly
stockholders must rely on stock appreciation for any return on
their investment in us.
We anticipate that we will retain our earnings for future growth
and therefore do not anticipate paying cash dividends in the
future. As a result, only appreciation of the price of our
common stock will provide a return to investors. Investors
seeking cash dividends should not invest in our common stock.
38
Our
executive officers, directors and current and principal
stockholders own a large percentage of our voting common stock
and could limit new stockholders influence on corporate
decisions or could delay or prevent a change in corporate
control.
Our directors, executive officers and current holders of more
than 5% of our outstanding common stock, together with their
affiliates and related persons, beneficially own, in the
aggregate, approximately 46% of our outstanding common stock. As
a result, these stockholders, if acting together, will have the
ability to determine the outcome of all matters submitted to our
stockholders for approval, including the election and removal of
directors and any merger, consolidation or sale of all or
substantially all of our assets and other extraordinary
transactions. The interests of this group of stockholders may
not always coincide with our corporate interests or the
interests of other stockholders, and they may act in a manner
with which you may not agree or that may not be in the best
interests of other stockholders. This concentration of ownership
may have the effect of:
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delaying, deferring or preventing a change in control of our
company;
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entrenching our management
and/or Board;
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impeding a merger, consolidation, takeover or other business
combination involving our company; or
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discouraging a potential acquirer from making a tender offer or
otherwise attempting to obtain control of our company.
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Risks
Related to the Combined Businesses Following the Stock
Purchase
In addition to the other information included in this proxy
statement, you should carefully consider the following risks
before deciding whether to vote for approval of the issuance of
the shares of our common stock in the Stock Purchase or the
increase in the number of shares issuable under our 2005 Plan.
Risks related to NxStages business are described above
under Risks Related to NxStage. In the event the
Stock Purchase is completed, we will also face the following
risks.
The
combined businesses of NxStage and Medisystems will continue to
rely upon the sale of a limited number of
products.
The Medisystems business relies nearly exclusively upon
the sale of a few key disposable products, including bloodlines
and needles, and this is expected to continue for the
foreseeable future. NxStages business relies nearly
exclusively upon the sale of the System One, and this is
expected to continue for the foreseeable future. Although the
acquisition of Medisystems business will broaden
NxStages product offerings, the combined business will
continue to rely upon the sale of a limited number of key
products primarily applicable to the dialysis business. To the
extent that any of the combined businesses primary
products are no longer successful or are withdrawn from the
market for any reason, our combined businesses will suffer and
we do not have other significant products in development that
could replace these revenues.
The
future growth of Medisystems business will depend on the
successful launch and market acceptance of Medisystems
StreamLine2 bloodline product.
The future growth of the Medisystems business depends upon
the successful launch and market acceptance of Medisystems
latest generation bloodline product, StreamLine2. StreamLine2 is
designed to be a high-quality, high-performance bloodline that
promises to yield valuable savings and improved patient outcomes
for those clinics that adopt it for use. Market penetration of
this product is quite limited to date, and it is not possible to
predict whether and to what extent current and future customers
will elect to use this product instead of more established
Medisystems or competitive bloodlines. If we are unable to
convert customers to the StreamLine2 product and receive more
widespread commercial acceptance of this product, our ability to
achieve our growth objectives for the Medisystems business
could be impaired.
39
The
future profitability, growth and success of our combined
businesses will also depend on our ability to achieve further
product cost reductions by our combined
operations.
The future profitability and growth of our combined businesses
depends upon our ability to achieve further product cost
reductions by our combined operations including improved
manufacturing efficiencies at Medisystems manufacturing
facilities and product design synergies. If product cost
reductions are not achieved on a timely basis, the future
profitability of our combined businesses will be delayed and may
not be delivered.
The
combined businesses will need to invest capital to expand
Medisystems manufacturing facilities in Mexico and Italy
to support anticipated increased product demand for System One
cartridges and StreamLine2. We cannot guarantee that cash from
operations will be sufficient to finance this expansion, or that
we will complete this expansion on a timely and cost-effective
basis.
To support the expected increased demand for the System One
disposable cartridges and StreamLine2, we will need to increase
the scale of Medisystems manufacturing and molding
operations in Mexico and Italy. This will require the investment
of capital over the next two years. It is possible that cash
flow from our combined operations may not be sufficient to
support our capital needs, and that we may require additional
financing to fund the expansion. We cannot be certain that
financing will be available in the amounts or on terms
acceptable to us, or at all. If we are unable to obtain this
additional financing when needed, we may be required to delay,
reduce the scope of, or eliminate one or more aspects of our
capacity expansion plans, which could harm the growth or
profitability of our combined businesses.
The planned expansion of Medisystems manufacturing
facilities will also require the purchase of specialized
equipment and specialized construction. We cannot guarantee that
we will be able to purchase all of the necessary equipment on
satisfactory terms or timing, or that the necessary construction
will be completed on a cost-effective or timely basis. Any delay
in purchasing equipment or construction could harm the growth or
profitability of our combined businesses.
Medisystems
currently relies upon a third-party manufacturer to manufacture
a significant percentage of its bloodline products using
Medisystems supplied components. This manufacturers
contractual obligation to manufacture such products for
Medisystems expires in June 2008. In the event this agreement is
not renewed or extended upon favorable terms, if at all, or in
the event Medisystems is unable to sufficiently expand its
manufacturing capabilities prior to June 2008 to support its
requirements, the combined businesses growth and ability
to meet customer demand would be impaired.
Historically, Medisystems has relied upon a third-party
manufacturer, Kawasumi Laboratories, Inc. which we refer to as
Kawasumi, to manufacture a significant percentage of its
bloodline products using Medisystems supplied components.
This third party has a strong history of manufacturing
high-quality product for Medisystems. Kawasumis
contractual obligation to manufacture bloodlines for Medisystems
expires in June 2008. We cannot be certain this agreement will
be renewed or extended on favorable terms, if at all, that we
would be able to manufacture independently the volume of
products currently manufactured by Kawasumi, or that we would be
able to manufacture products at the same cost at which
Medisystems could purchase products from Kawasumi under a new
agreement, the failure of any of which could impair our combined
businesses.
Medisystems
also relies upon Kawasumi to supply all of its finished goods
needles.
Medisystems depends solely on Kawasumi for all of its finished
goods needles. Kawasumis obligation to supply needles to
Medisystems expires in February 2011. In the event this
agreement is not renewed or extended upon favorable terms, if at
all, the revenues and profitability of the combined businesses
will be impaired. It is not certain whether Medisystems would be
able to obtain another source of quality needles if its
agreement with Kawasumi is not renewed.
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Medisystems
business relies heavily upon third-party
distributors.
The majority of Medisystems revenues comes from three
distributors, which collectively accounted for approximately 90%
of Medisystems revenues in 2006, with its primary
distributor, Schein, accounting for 65% of Medisystems
revenues in 2006. Schein recently agreed to extend its
distribution relationship with Medisystems through July 2009.
Medisystems contracts with its other two distributors are
scheduled to expire in October 2008 and July 2009.
Medisystems relationship with Schein, in particular, is
very significant for its business and any failure to continue
this relationship would be harmful to the combined businesses,
because Medisystems has no direct sales force and NxStages
sales force has no experience selling bloodlines or needles.
The
combined businesses will continue to rely heavily upon DaVita as
a key customer. The partial or complete loss of DaVita as a
customer could materially impair our combined financial
results.
We expect that DaVita will continue to be a significant customer
of the combined businesses. Sales through distributors to DaVita
of Medisystems products accounted for approximately 38% of
Medisystems revenues in 2006, and NxStages sales to
DaVita accounted for approximately 19% of our revenues in 2006.
Medisystems contract with DaVita includes certain minimum
order requirements; however, these can be reduced significantly
under certain circumstances. DaVitas contractual
commitments to purchase Medisystems needles expire in
December 2007; and its commitments to purchase Medisystems
bloodlines expire in September 2008. We cannot guarantee we will
be able to negotiate an extension of Medisystems agreement
with DaVita on favorable terms, if at all, or the extent to
which DaVita will purchase Medisystems products following
the completion of the Stock Purchase. NxStages agreement
with DaVita does not impose minimum purchase requirements, and
expires as early as 2010. The partial or complete loss of DaVita
as a customer of our combined businesses would materially impair
our combined financial results.
Medisystems,
like NxStage, obtains some of its raw materials or components
from a single source or a limited group of suppliers. It obtains
sterilization services from a single supplier. The partial or
complete loss of one of these suppliers could cause significant
production delays, an inability to meet customer demand and a
substantial loss in revenues.
Medisystems, like NxStage, depends on a number of single-source
suppliers for some of the raw materials and components it uses
in its products. It also obtains sterilization services from a
single supplier. The dependence of the combined companies on
single-source suppliers of raw materials, components and
production services will continue to expose us to several risks,
including disruptions in supply, price increases, late
deliveries and an inability to meet customer demand. This could
lead to customer dissatisfaction, damage to our reputation or
customers switching to competitive products.
Finding alternative sources for these raw materials, components
and production services would be difficult in several cases and
may entail a significant amount of time and disruption. In other
cases, it may not be possible to find an alternative source of
supply.
Resin
is a key input material to the manufacture of Medisystems
products and our System One cartridge. Rising oil prices affect
both the pricing and availability of this material. Continued
escalation of oil prices could affect our ability to obtain
sufficient supply of resin at the prices we need to manufacture
our products at current rates of profitability.
Medisystems currently sources resin from a small number of
suppliers. Rising oil prices over the last several years have
resulted in significant price increases for this material. We
cannot guarantee that prices will not continue to increase.
NxStages and Medisystems contracts with customers
restrict each of our ability to immediately pass on these price
increases, and we cannot guarantee that future pricing to
customers will be sufficient to accommodate increasing input
costs.
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Medisystems
has labor agreements with its production employees in Italy and
in Mexico. We cannot guarantee that Medisystems will not in the
future face strikes, work stoppages, work slowdowns, grievances,
complaints, claims of unfair labor practices, other collective
bargaining disputes or in Italy, anti-union behavior, that may
cause production delays and negatively impact our ability to
deliver our products on a timely basis.
MDS Italy has a national labor contract with Contratto
collettivo nazionale di lavoro per gli addetti
allindustria della gomma cavi elettrici ed affini e
allindustria delle materie plastiche, and MDS Mexico has
entered into a collective bargaining agreement with a Union
named Mexico Moderno de Trabajadores de la Baja California
C.R.O.C. Medisystems has not to date experienced strikes, work
stoppages, work slowdowns, grievances, complaints, claims of
unfair labor practices, other collective bargaining disputes, or
in Italy, anti-union behavior, however we cannot guarantee that
Medisystems will not be subject to such activity in the future.
Any such activity would likely cause production delays, and
negatively affect our ability to deliver our production
commitments to customers, which could adversely affect our
reputation and cause our combined businesses and operating
results to suffer.
Medisystems
and NxStage each have recently developed products and have
limited manufacturing experience with these
products.
Both Medisystems and NxStage continue to develop new products
and make improvements to existing products. As such, both
businesses have limited manufacturing experience with certain of
their products, including Medisystems StreamLine2 product.
The combined companies will continue to be exposed to risks
relating to product quality, reliability and cost to produce
until the manufacturing processes for these new products mature.
Medisystems
does not have long-term supply contracts with many of its
third-party suppliers.
Medisystems purchases raw materials and components from
third-party suppliers, including some single source suppliers,
through purchase orders and does not have long-term supply
contracts with many of these third-party suppliers. Many of its
third-party suppliers, therefore, are not obligated to perform
services or supply products for any specific period, in any
specific quantity or at any specific price, except as may be
provided in a particular purchase order.
Medisystems does not maintain large volumes of inventory from
most of its suppliers. If the combined businesses inaccurately
forecast demand for finished goods, our ability to meet customer
demand could be delayed and our competitive position and
reputation could be harmed. In addition, if we fail to
effectively manage our relationships with these suppliers, we
may be required to change suppliers, which would be time
consuming and disruptive and could lead to disruptions in
product supply, which could permanently impair our customer base
and reputation.
Medisystems
historical bloodline business has been a commodities business
subject to pricing pressure and the significant influences of
consolidated buying power. Unless Medisystems can demonstrate
sufficient product differentiation in its bloodline business
through StreamLine2 or products that we introduce in the future,
Medisystems will continue to be susceptible to further pressures
to reduce product pricing and more vulnerable to the loss of its
bloodline business to competitors in the dialysis
industry.
Medisystems bloodline business has historically been a
commodities business. Medisystems has competed favorably and
gained share through the development of a high quality,
low-cost, standardized blood tubing set, that could be used on
several different dialysis machines. Medisystems continues to
compete favorably in the dialysis bloodline business, but is
increasingly subject to pricing pressures, especially given
recent market consolidation in the dialysis services industry,
with Fresenius and DaVita collectively controlling approximately
61% of U.S. dialysis services business. NxStages
product, the System One, has been less subject to these
pressures given its significant product differentiation from
other competitive products, and its unique suitability to the
home hemodialysis application. If the Stock Purchase is
completed, the combined businesses will be subject to the
pressures of a commodities business, unless we can successfully
demonstrate to customers the differentiating features of the
42
StreamLine2 product or products that we introduce in the future.
If we are unsuccessful in establishing this differentiation, we
may be susceptible to further pressures to reduce Medisystems
product pricing and more vulnerable to the loss of
Medisystems bloodline business to competitors in the
dialysis industry.
The
combined businesses will be subject to an increased risk of
costly and damaging product liability claims and may not be able
to maintain sufficient product liability insurance to cover
claims against us.
With the expansion of our product offerings, the combined
companies will be subject to an increased risk of product
liability claims. If any of our products is found to have caused
or contributed to injuries or deaths, we could be held liable
for substantial damages. Claims of this nature may also
adversely affect our reputation, which could damage our position
in the market. Although NxStage has not been a party to any such
claims, Medisystems has been, and it is reasonably likely that
the combined businesses will be, party to future product
liability claims. Although we maintain insurance, including
product and excess liability insurance, we cannot provide
assurance that any claim that may be brought against us will not
result in court judgments or settlements in amounts that are in
excess of the limits of our insurance coverage. Our insurance
policies also have various exclusions, and we may be subject to
a product liability claim for which we have no coverage. We will
have to pay any amounts awarded by a court or negotiated in a
settlement that exceed our coverage limitations or that are not
covered by our insurance.
Any product liability claim brought against us, with or without
merit, could result in the increase of our product liability
insurance rates or the inability to secure additional insurance
coverage in the future. A product liability claim, whether
meritorious or not, could be time consuming, distracting and
expensive to defend and could result in a diversion of
management and financial resources away from our primary
business, in which case our business may suffer.
We
expect to increase the level of our insurance coverage following
the completion of the proposed Stock Purchase, however, future
claims could exceed our applicable insurance
coverage.
The combined companies will continue to maintain insurance for
property and general liability, directors and
officers liability, products liability, workers
compensation and other coverage in amounts and on terms deemed
adequate by management based on our expectations for future
claims. Although we may increase the level of our insurance
coverage following the completion of the Stock Purchase, future
claims could exceed our applicable insurance coverage, or in
some instances our coverage may not cover the applicable claims.
The
combined businesses will have increased reliance upon
international manufacturing operations, and if we are unable to
manage these risks effectively, our combined businesses could
suffer.
In addition to NxStages operations in Germany and its new
operations in Mexico, the combined businesses will have
operations in Italy and additional operations in Mexico. The
combined businesses will also have increased reliance upon
foreign vendors for the purchase of finished goods and supplies.
We will be subject to increased risks and challenges that
specifically relate to these international operations, and we
may not be successful if we are unable to meet and overcome
these challenges. These risks include fluctuations in foreign
currency exchange rates that may increase the U.S. dollar
cost of foreign third-party supplies, increased costs associated
with sourcing and shipping goods internationally, increased
difficulty managing operations in multiple locations and local
regulations that may restrict or impair our ability to conduct
our operations.
The
activities of the combined businesses will involve the import of
finished goods into the United States from foreign countries,
subject to customs inspections and duties, and the export of
components and certain other products from other countries into
Mexico and Thailand. If we misinterpret or violate these laws,
or if laws governing our exemption from certain duties changes,
we could be subject to significant fines, liabilities or other
adverse consequences.
Medisystems imports into the United States disposable medical
supplies from Thailand and Mexico. Medisystems also imports into
the United States disposable medical components from Germany,
Italy and
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Thailand and exports components and assemblies into Mexico and
Italy. The import and export of these items are subject to
extensive laws and regulations with which the combined
businesses will need to comply. To the extent we fail to comply
with these laws or regulations, or fail to interpret our
obligations accurately, we may be subject to significant fines,
liabilities and a disruption to our ability to deliver product,
which could cause our combined businesses and operating results
to suffer.
To the extent there are modifications to Generalised System of
Preferences or cancellation of the Nairobi Protocol
Classification such that our products would be subject to
duties, our profitability would also be negatively impacted.
The activity of the combined businesses will involve the
purchase of finished goods, components and assemblies from
foreign countries, which involves exchange rate risk.
The combined businesses will be exposed to significant exchange
rate risk in the Thai Baht, Euro and Peso. The U.S. dollar
has weakened significantly against the Euro and Thai Baht over
the last five years and may continue to do so. To the extent we
fail to control our exchange rate risk, our profitability may
suffer and our ability to maintain mutually beneficial and
profitable relationships with key vendors could be impaired.
We may
face challenges in integrating Medisystems business with
NxStages and, as a result, may not realize the expected
benefits of the proposed Stock Purchase.
Even though NxStages and Medisystems businesses are
relatively distinct, integrating the operations and personnel of
Medisystems and NxStage will require a significant investment of
managements time and effort as well as the investment of
capital, particularly with respect to information systems. The
successful integration of Medisystems and NxStage will require,
among other things, coordination of certain manufacturing
operations and sales and marketing operations and the
integration of Medisystems operations into the NxStage
organization. The diversion of the attention of NxStages
and Medisystems senior management and any difficulties
encountered in the process of combining the companies could
cause the disruption of, or a loss of momentum in, the
activities of the combined businesses.
The inability to successfully integrate the operations and
personnel of Medisystems and NxStage, or any significant delay
in achieving integration, could have a material adverse effect
on the combined businesses after the completion of the
acquisition, and, as a result, on the market price of
NxStages common stock.
NxStage
expects to incur significant costs associated with the proposed
Stock Purchase.
NxStage estimates that it will incur direct transaction costs of
approximately $3.5 million in connection with the proposed
Stock Purchase. In addition, the combined businesses may incur
charges to operations that they cannot currently reasonably
estimate in the quarter in which the Stock Purchase is completed
or the following quarters to reflect costs associated with
integrating the two businesses. There can be no assurance that
the combined businesses will not incur additional charges
relating to the transaction in subsequent periods.
The
success of the combined businesses will depend on the services
of each of our senior executives as well as certain key
engineering, scientific, manufacturing, clinical and marketing
personnel, the loss of whom could negatively affect the combined
businesses.
Our success has always depended upon the skills, experience and
efforts of our senior executives and other key personnel,
including our research and development and manufacturing
executives and managers. Following the completion of the Stock
Purchase, this will be even more important as we work to
integrate our businesses. For both Medisystems and NxStage, much
of our expertise is concentrated in relatively few employees,
the loss of whom for any reason could negatively affect our
business. Medisystems has experienced the loss of certain key
employees recently, and the failure of further employees to
remain with the combined businesses could be harmful to the
success of the combined businesses. In March 2006,
Medisystems Chief
44
Financial Officer and Corporate Controller resigned. In October
2006, Medisystems Vice President of Regulatory and Quality
Assurance resigned. In August 2007, NxStages Chief
Operating Officer announced his intention to resign effective
upon the completion of the Stock Purchase. Competition for our
highly skilled employees is intense and we cannot prevent the
future resignation of any employee. Most of the combined
businesses employees have agreements which impose
obligations that may prevent a former employee from working for
a competitor for a period of time; however, these clauses may
not be enforceable, or may be enforceable only in part.
The
combined business, like NxStage, will continue to require
significant capital to build the business, and financing may not
be available to us on reasonable terms, if at all.
The combined business will continue to require significant
working capital for the manufacture and rental of equipment by
our customers as well as the expansion and integration of
Medisystems operations. If our existing resources are
insufficient to satisfy our liquidity requirements, we may need
to sell additional equity or debt securities. Any sale of
additional equity or debt securities may result in additional
dilution to our stockholders, and we cannot be certain that we
will be able to obtain additional public or private financing in
amounts, or on terms, acceptable to us, or at all.
Our
executive officers and directors, together with their affiliates
and related persons, own a large percentage of our voting common
stock and could limit new stockholders influence on
corporate decisions or could delay or prevent a change in
corporate control.
Our directors and executive officers, together with their
affiliates and related persons, beneficially own, in the
aggregate, approximately 47.6% of our outstanding common stock
assuming the issuance of 6,500,000 shares of our common
stock to Mr. Utterberg pursuant to the Stock Purchase. The
interests of this group of stockholders may not always coincide
with our corporate interests or the interests of other
stockholders, and they may act in a manner with which you may
not agree or that may not be in the best interests of other
stockholders. This concentration of ownership may have the
effect of:
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delaying, deferring or preventing, or alternatively,
accelerating or causing, a change in control of our company;
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entrenching our management
and/or board
of directors;
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impeding a merger, consolidation, takeover or other business
combination involving our company; or
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discouraging a potential acquirer from making a tender offer or
otherwise attempting to obtain control of our company.
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45
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This proxy statement contains forward-looking statements that
involve substantial risks and uncertainties. All statements,
other than statements of historical facts, included in this
proxy statement regarding our strategy, future operations,
future financial position, future revenues, projected costs,
prospects and plans and objectives of management are
forward-looking statements. The words anticipates,
believes, estimates,
expects, intends, may,
plans, projects, will,
would and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. We
have based these forward-looking statements on our current
expectations and projections about future events. Although we
believe that the expectations underlying any of our
forward-looking statements are reasonable, these expectations
may prove to be incorrect and all of these statements are
subject to risks and uncertainties. Should one or more of these
risks and uncertainties materialize, or should underlying
assumptions, projections or expectations prove incorrect, actual
results, performance or financial condition may vary materially
and adversely from those anticipated, estimated or expected. We
have identified below some important factors that could cause
our forward-looking statements to differ materially from actual
results, performance or financial conditions:
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failure of the home hemodialysis market to expand or expand at
the rate we expect;
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our inability to grow our customer base and increase the
adoption rate of home hemodialysis;
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our inability to grow and sustain our critical care business;
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our inability to adequately grow our operations and attain
sufficient operating scale;
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our inability to obtain adequate profit margins;
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changes in Medicare dialysis reimbursement policies, the
composite rate or the reimbursement policies or rates of other
governmental or private payors;
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regulatory action by the FDA and changes in, or our failure to
comply with, government regulations;
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our inability to achieve product development milestones or the
introduction of technical innovations or new products by our
competitors;
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our inability to effectively protect our intellectual property
and not infringe on the intellectual property of others;
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our inability to raise sufficient capital when necessary;
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loss of any significant suppliers, especially sole-source
suppliers;
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loss of key personnel;
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liability resulting from litigation;
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failure to complete the Stock Purchase or to realize the
benefits of the proposed Stock Purchase;
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failure to successfully integrate NxStage and the MDS Entities;
and
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other factors discussed elsewhere in this proxy statement.
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We may not actually achieve the plans, intentions or
expectations disclosed in our forward-looking statements and you
should not place undue reliance on our forward-looking
statements. We have included important factors in the cautionary
statements included in this proxy statement, particularly in the
section entitled Risk Factors that we believe could
cause actual results or events to differ materially from the
forward-looking statements that we make. Our forward-looking
statements do not reflect the potential impact of any future
acquisitions, mergers, dispositions, joint ventures or
investments we may make. We do not assume any obligation to
update any forward-looking statements, whether as a result of
new information, future events or otherwise, except as required
by law.
46
THE
SPECIAL MEETING OF NxSTAGE STOCKHOLDERS
General
We are furnishing this proxy statement to our stockholders in
connection with the solicitation of proxies by our board of
directors for use at the special meeting of stockholders to be
held
on ,
2007 and at any adjournment, postponement or continuation
thereof. This document is first being furnished to our
stockholders on or
about ,
2007.
Date,
Time and Place
The special meeting of our stockholders will be held at the
offices of WilmerHale, 60 State Street, Boston, Massachusetts
02109,
on ,
2007 at a.m., local time.
Purpose
of the Special Meeting
At the special meeting, our stockholders will consider and act
upon the following matters:
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Proposal One approval of the issuance of
the Stock Purchase Shares; and
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Proposal Two approval of an amendment to
our 2005 Plan to increase the number of shares of our common
stock that may be issued under the 2005 Plan by an additional
3,800,000 shares, of which no more than
1,500,000 shares may be issued as restricted stock awards.
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Record
Date, Shares of Common Stock Outstanding and Entitled to
Vote
We have fixed the close of business
on ,
2007 as the record date for determining the holders of our
common stock entitled to notice of and to attend and to vote at
the special meeting or at any adjournment thereof. As of the
close of business
on ,
2007, there
were shares
of our common stock outstanding and entitled to vote. Each share
of our common stock entitles its holder to one vote on each of
the matters presented at the special meeting.
Quorum
and Vote of NxStage Stockholders Required
A quorum of stockholders is necessary to hold a valid meeting. A
quorum will be present at the special meeting if shares of our
common stock representing a majority of the votes entitled to be
cast are represented in person or by proxy. If a quorum is not
present at the special meeting, we expect that the meeting will
be adjourned or postponed to solicit additional proxies.
Abstentions, votes FOR, votes AGAINST
and broker non-votes count as being present to
establish a quorum. A broker non-vote occurs when a
broker is not permitted to vote because the broker does not have
instructions from the beneficial owner of the shares of common
stock.
The proposals to be voted on at the special meeting will require
the following approvals:
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Proposal One the approval of the Stock
Purchase Shares requires the affirmative vote of a majority of
the votes cast at the special meeting at which a quorum is
present.
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Proposal Two the approval of the
proposed amendment to our 2005 Plan requires the affirmative
vote of a majority of the votes cast at the special meeting at
which a quorum is present.
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If you do not submit a proxy card or vote at the special
meeting, your shares of common stock will not be counted as
present for the purpose of determining a quorum and will have no
effect on the outcome of the proposal to approve
Proposal One or Proposal Two.
47
Voting
Instructions
The following section summarizes important information on how to
vote your shares of common stock.
Voting
by Proxy
If you are a record holder, meaning your shares are registered
in your name, you may vote over the Internet, by telephone, by
mail or in person at the special meeting pursuant to the
following instructions:
Over the Internet: Go to the website of our
tabulator, Computershare Investor Services, at
www.investorvote.com. Use the vote control number printed
on your enclosed proxy card to access your account and vote your
shares. You must specify how you want your shares voted or your
Internet vote cannot be completed and you will receive an error
message. Your shares will be voted according to your
instructions.
By Telephone: Call
1-800-652-VOTE
(8683) toll free from the United States, Canada and Puerto Rico,
and follow the instructions on your enclosed proxy card. You
must specify how you want your shares voted and confirm your
vote at the end of the call or your telephone vote cannot be
completed. Your shares will be voted according to your
instructions.
By Mail: Complete and sign your enclosed proxy
card and mail it in the enclosed postage prepaid envelope to
Computershare Investor Services. Your shares will be voted
according to your instructions. If you do not specify how you
want your shares voted, they will be voted as recommended by our
board of directors.
In Person at the Special Meeting: If you
attend the special meeting, you may deliver your completed proxy
card in person or you may vote by completing a ballot, which we
will provide to you at the meeting.
Voting
of Shares Held in Street Name
If your shares are held in street name, meaning they
are held for your account by a broker or other nominee, you will
receive instructions from your broker or other nominee regarding
how to vote your shares over the Internet, by telephone or by
mail. You should follow those instructions. If you wish to vote
your shares in person at the special meeting, contact your
broker or other nominee who holds your shares to obtain a
brokers proxy card and bring it with you to the special
meeting. You will not be able to vote in person at the
special meeting unless you have a proxy from your broker issued
in your name giving you the right to vote your shares.
Voting
of Proxies at the Special Meeting
All properly executed proxies that we receive prior to the vote
at the special meeting, and that are not revoked, will be voted
in accordance with the instructions indicated on the proxies or,
if no direction is indicated, to approve the issuance of the
Stock Purchase Shares and the amendment to our 2005 Plan.
Properly executed proxies, other than proxies voting against the
issuance of the Stock Purchase Shares
and/or the
amendment to our 2005 Plan, will also be voted for any
adjournment or postponement of our special meeting of
stockholders for the purpose of soliciting additional votes to
approve Proposal One and Proposal Two, if necessary.
Our board of directors does not currently intend to bring any
other business before the special meeting and, so far as
NxStages board of directors knows, no other matters are to
be brought before the special meeting. If other business
properly comes before the special meeting, the proxies will vote
in accordance with their own judgment.
Copies of solicitation materials will be furnished to banks,
brokerage houses, fiduciaries and custodians holding in their
names shares of our common stock beneficially owned by others to
forward to such beneficial owners. In addition to solicitation
by use of the mails, proxies may be solicited by directors,
officers, employees or agents of NxStage in person or by
telephone, telegram or other means of communication. No
48
additional compensation will be paid to directors, officers or
other regular employees of NxStage for such services.
Stockholders may revoke their proxies at any time prior to use
by delivering to our corporate secretary a signed notice of
revocation or a later-dated signed proxy, or by attending the
special meeting in person and revoking the proxy by signing a
notice of revocation. If you vote your shares over the Internet
or by telephone, only your latest Internet or telephone vote
will be counted at the special meeting. Attendance at the
special meeting does not in itself constitute the revocation of
a proxy. Stockholders who have instructed their broker to vote
their shares of common stock must follow their brokers
directions in order to change those instructions. You may also
attend the special meeting in person instead of submitting a
proxy; however, please see the instructions above under
Voting of Shares Held in Street-Name if you wish to
vote such shares in person at the special meeting.
We will pay for all costs incurred in connection with the
solicitation of proxies from our stockholders on behalf of our
board of directors, including assembly, printing and mailing of
this document, its related attachments, and the proxy card. We
have engaged Georgeson Shareholder Communications, Inc., a proxy
solicitation firm, to solicit proxies from our stockholders. For
these services, we expect to pay a fee of approximately $7,500
plus expenses. Our directors, officers and employees may solicit
proxies by telephone, email, facsimile and in person, without
additional compensation. Upon request, we will reimburse
brokerage houses and other custodians, nominees and fiduciaries
for their reasonable out-of-pocket expenses for distributing
proxy materials.
MATTERS
BEING SUBMITTED TO A VOTE OF NxSTAGE STOCKHOLDERS
Proposal One
Approval of the Issuance of the Stock Purchase Shares
At the special meeting and any adjournment or postponement
thereof, our stockholders will be asked to consider and vote
upon a proposal to approve the issuance of the Stock Purchase
Shares.
Further information with respect to the issuance of the Stock
Purchase Shares, the Stock Purchase, the MDS Entities and
Mr. Utterberg is contained elsewhere in this proxy
statement, including the sections The Stock Purchase
beginning on page 55 and The Stock Purchase
Agreement beginning on page 68.
OUR BOARD
OF DIRECTORS RECOMMENDS A VOTE FOR THE ISSUANCE OF
THE STOCK PURCHASE SHARES TO MR. UTTERBERG IN CONNECTION
WITH THE STOCK PURCHASE
Proposal Two
Approval of an Amendment to Our 2005 Plan
Overview
At the special meeting and any adjournment thereof, our
stockholders will be asked to consider and vote upon a proposal
to increase by 3,800,000 the number of shares of our common
stock available for issuance under the 2005 Plan. Of the
3,800,000 additional shares, no more than 1,500,000 shares may
be granted as restricted stock awards. Our board of directors
believes that our continued growth and profitability depends, in
large part, on our ability to maintain a competitive position in
attracting, retaining and motivating key employees with
experience and ability. We believe the 2005 Plan furthers these
objectives. As of the date of this proxy statement, the maximum
number of shares we are currently authorized to issue, subject
to adjustment in the event of stock splits and other similar
events, pursuant to awards granted under the 2005 Plan, is
3,601,459. At July 31, 2007, options for the purchase of
465,256 shares of our common stock remained available for
grant under the plan.
49
If the Stock Purchase is completed, our employee population will
grow from approximately 300 to 1,000. In order for us to be able
to grant equity incentives to these new employees and to support
our continued growth and compensation needs, our board of
directors has amended the 2005 Plan, subject to stockholder
approval, to increase the total number of shares that may be
issued under the plan by 3,800,000 shares, of which no more than
1,500,000 may be granted as restricted stock awards, restricted
stock units, and other stock-based awards.
Our board of directors approved several additional amendments to
the 2005 Plan which did not require the approval of our
stockholders. The 2005 Plan was amended: (1) to remove the
evergreen provision, which provided for an annual
automatic increase of the number of shares available under the
plan, (2) to eliminate the return of shares received by us
in connection with the net exercise of options to the available
pool under the plan, (3) to provide that all options and
stock appreciation rights granted under the 2005 Plan must be
granted at fair market value on the date of grant and have a
term no more than 10 years, and (4) to provide that
stock options issued under the plan may not be (a) repriced
by (x) lowering the option exercise price of an option or
(y) canceling an outstanding stock option and replacing it
with a stock option with a lower exercise price, or
(b) cashed out by us, unless such action has been approved
by our stockholders.
Outstanding
Stock Option and Restricted Stock Data
As of June 30, 2007, stock options to purchase
3,153,724 shares of our common stock were outstanding, the
weighted average option grant price for these options was $7.37
and the weighted average contractual life of which was 5.8. In
addition, we had 15,839 shares of restricted stock
outstanding.
The weighted-average fair value of stock options granted during
the six months ended June 30, 2007 was $11.92. The fair
value of stock options at date of grant was estimated using the
Black-Scholes option-pricing model with the following
assumptions:
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Six Months Ended
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June 30, 2007
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Expected life
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4.75 years(1)
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Risk-free interest rate
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4.69%(2)
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Expected stock price volatility
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75%(3)
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Expected dividend yield
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(1) |
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The expected term was determined using the simplified method for
estimating expected life of plain-vanilla options. |
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(2) |
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The risk-free interest rate for each grant is equal to the
U.S. Treasury rate in effect at the time of grant for
instruments with an expected life similar to the expected option
term. |
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Because we have no options that are traded publicly and because
of its limited trading history as a public company, the stock
volatility assumption is based on an analysis of the volatility
of the common stock of comparable companies in the medical
device and technology industries. |
We have estimated expected forfeitures of stock options with the
adoption of SFAS 123R and record stock-based compensation
net of estimated forfeitures. In developing a forfeiture rate
estimate, we considered our historical experience, our growing
employee base and the limited trading history of our common
stock.
Summary
of the 2005 Plan
The following is a brief summary of the material terms of our
2005 Plan.
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Types of
Awards
The 2005 Plan provides for the grant of incentive stock options
intended to qualify under Section 422 of the Internal
Revenue Code of 1986, as amended, or the Code, non-statutory
stock options, stock appreciation rights, restricted stock,
restricted stock units and other stock-based awards as described
below, collectively referred to as Awards.
Incentive Stock Options and Nonstatutory Stock
Options. Optionees receive the right to purchase
a specified number of shares of common stock at a specified
option price and subject to such other terms and conditions as
are specified in connection with the option grant. Options may
be granted at an exercise price equal to or greater than the
fair market value of the common stock on the date of grant.
Under present law, incentive stock options and options intended
to qualify as performance-based compensation under
Section 162(m) of the Code may not be granted at an
exercise price less than 100% of the fair market value of our
common stock on the date of grant (or less than 110% of the fair
market value in the case of incentive stock options granted to
optionees holding more than 10% of the voting power of NxStage).
Options may not be granted for a term in excess of ten years.
The 2005 Plan permits the following forms of payment of the
exercise price of options: (i) payment by cash, check or
through a broker providing for such method of payment,
(ii) subject to certain conditions, surrender to us of
shares of our common stock, (iii) delivery to us of a
promissory note on terms determined by our board of directors,
(iv) any other lawful means, or (v) any combination of
these forms of payment.
Stock Appreciation Rights. A stock
appreciation right, or SAR, is an award entitling the holder,
upon exercise, to receive an amount in our common stock
determined by reference to appreciation, from and after the date
of grant, in the fair market value of a share of common stock.
SARs may not be granted at an exercise price less than 100% of
the fair market value of our common stock on the date of grant
and may be granted independently or in tandem with an option.
Restricted Stock Awards; Restricted Stock
Units. Restricted stock awards entitle recipients
to acquire shares of our common stock, subject to our right to
repurchase all or part of such shares from the recipient in the
event that the conditions specified in the applicable Award are
not satisfied prior to the end of the applicable restriction
period established for such Award. Restricted stock units
entitle recipients to receive shares of common stock to be
delivered at the time such shares of common stock vest.
Other Stock-Based Awards. Under the 2005 Plan,
our board of directors has the right to grant other Awards based
upon our common stock having such terms and conditions as the
board may determine, including the grant of shares based upon
certain conditions, the grant of Awards that are valued in whole
or in part by reference to, or otherwise based on, shares of
common stock, and the grant of Awards entitling recipients to
receive shares of common stock to be delivered in the future.
Transferability
of Awards
Except as our board of directors may otherwise determine or
provide in an Award, Awards may not be sold, assigned,
transferred, pledged or otherwise encumbered by the person to
whom they are granted, either voluntarily or by operation of
law, except by will or the laws of descent and distribution or,
other than in the case of an incentive stock option, pursuant to
a qualified domestic relations order. During the life of the
participant, Awards are exercisable only by the participant.
Eligibility
to Receive Awards
Our employees, officers, directors, consultants and advisors are
eligible to be granted Awards under the 2005 Plan. Under present
law, however, incentive stock options may only be granted to our
employees. The maximum number of shares with respect to which
Awards may be granted to any participant under the 2005 Plan may
not exceed 1,000,000 shares per calendar year.
Plan
Benefits
As of July 31, 2007, approximately 266 persons were
eligible to receive Awards under the 2005 Plan, including our 5
named executive officers and 6 non-employee directors.
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The following table sets forth, as of July 31, 2007, the
stock option and restricted stock grants made under the 2005
Plan since its adoption.
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No. of Options/
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Shares Granted
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Executive Officers:
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Jeffrey H. Burbank
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Robert S. Brown
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200,000
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Philip R. Licari
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221,989
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Winifred L. Swan
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10,000
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Joseph E. Turk, Jr.
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All Executive Officers as a Group
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431,989
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All Directors who are not
Executive Officers as a Group
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309,499
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Each Associate of any of such
Directors or Executive Officers
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Each Other Person who Received or
is to Receive 5% of Awards under the 2005 Plan
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All Employees, who are not
Executive Officers, as a Group(1):
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3,129,604
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This number excludes stock options that expired prior to being
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Administration
The 2005 Plan is administered by our board of directors. The
board has the authority to adopt, amend and repeal the
administrative rules, guidelines and practices relating to the
2005 Plan and to interpret the provisions of the 2005 Plan.
Pursuant to the terms of the 2005 Plan, the board may delegate
authority under the 2005 Plan to one or more committees or
subcommittees of the board.
Subject to any applicable limitations contained in the 2005
Plan, the board of directors, the compensation committee, or any
other committee to whom the board of directors delegates
authority, as the case may be, selects the recipients of Awards
and determines (1) the number of shares of common stock
covered by options and the dates upon which such options become
exercisable, (2) the exercise price of options,
(3) the duration of options (which may not exceed
10 years), and (4) the number of shares of common
stock subject to any SAR, restricted stock award, restricted
stock unit award or other stock-based Awards and the terms and
conditions of such Awards, including conditions for repurchase,
issue price and repurchase price.
We will be required to make appropriate adjustments in
connection with the 2005 Plan and any outstanding Awards to
reflect stock splits, stock dividends, recapitalizations,
spin-offs and other similar changes in capitalization.
The 2005 Plan also contains provisions addressing the
consequences of any Reorganization Event, which is
defined as (a) any merger or consolidation of NxStage with
or into another entity as a result of which all of our common
stock converted into or exchanged for the right to receive cash,
securities or other property, or is cancelled or (b) any
exchange of all of our common stock for cash, securities or
other property pursuant to a share exchange transaction or
(c) any liquidation or dissolution of NxStage. Upon the
occurrence of a reorganization event, all outstanding options
will be assumed or equivalent options substituted by the
successor corporation. If the reorganization event also
constitutes a change in control event (as defined in the 2005
Plan), 50% of the shares that underlie each option outstanding
under the 2005 Plan and that are unvested as of the date of the
reorganization event will become immediately exercisable. If a
change of control event occurs and within one year of the change
in control event an option holders employment with us or
our succeeding corporation is terminated by such holder for good
reason (as defined in the 2005 Plan) or is terminated by us or
the succeeding corporation without cause (as defined in the 2005
Plan), each option held by the holder will become immediately
exercisable for the remaining 50% of the shares that had been
unvested as of the date of the change of control event.
Notwithstanding the foregoing, if the acquiring or succeeding
corporation in a reorganization event does not agree to assume
or substitute for outstanding options, our board of directors
will provide that all unexercised options will become
exercisable in full prior to the reorganization event and the
options, if unexercised, will terminate on the date the
reorganization event takes place. If under the terms of
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the reorganization event holders of our common stock receive
cash for their shares, our board may instead provide for a
cash-out of the value of any outstanding options less the
applicable exercise price.
Upon the occurrence of a reorganization event, or the signing of
an agreement with respect to a reorganization event, our
repurchase and other rights with respect to shares of restricted
stock will inure to the benefit of our successor and will apply
equally to the cash, securities or other property into which our
common stock is then converted.
Upon the occurrence of a change in control event (as defined in
the 2005 Plan) that does not also constitute a reorganization
event, 50% of the shares that underlie each option outstanding
under the 2005 Plan and that are unvested as of the date of the
change of control event will become immediately exercisable. If
a change of control event occurs and within one year of the
change in control event an option holders employment with
us or our succeeding corporation is terminated by such holder
for good reason (as defined in the 2005 Plan) or is terminated
by us or the succeeding corporation without cause (as defined in
the 2005 Plan), each option held by the holder will become
immediately exercisable for the remaining 50% of the shares that
had been unvested as of the date of the change of control event.
Upon the occurrence of a change in control event that does not
also constitute a reorganization event, 50% of the shares of
restricted stock outstanding under any award will become
immediately free of all restrictions and conditions. If within
one year of a change in control event a restricted stock
holders employment with us or our succeeding corporation
is terminated by such holder for good reason or is terminated by
us or the succeeding corporation without cause, the remaining
50% of such holders restricted stock that had been
unvested as of the date of the change of control event will
become immediately free of all restrictions and conditions.
Our board of directors or the compensation committee may at any
time provide that any Award will become immediately exercisable
in full or in part, free of some or all restrictions or
conditions, or otherwise realizable in full or in part, as the
case may be.
If any Award expires or is terminated, surrendered, canceled
without having been fully exercised, or forfeited in whole or in
part, the unused shares of our common stock covered by such
Award will again be available for grant under the 2005 Plan,
subject, however, in the case of incentive stock options, to any
limitations under the Code.
Substitute
Options
In connection with a merger or consolidation of an entity with
NxStage or the acquisition by us of property or stock of an
entity, our board of directors may grant options in substitution
for any options or other stock or stock-based awards granted by
such entity or an affiliate thereof. Substitute options may be
granted on such terms, as the board deems appropriate in the
circumstances, notwithstanding any limitations on options
contained in the 2005 Plan.
Amendment
or Termination
No Award may be made under the 2005 Plan after September 7,
2015 but Awards previously granted may extend beyond that date.
The board of directors may at any time amend, suspend or
terminate the 2005 Plan; provided that, no amendment requiring
stockholder approval under any applicable legal, regulatory or
listing requirement will become effective until such stockholder
approval is obtained.
Federal
Income Tax Consequences of the 2005 Plan
The following generally summarizes the U.S. federal income
tax consequences that generally will arise with respect to
awards granted under the 2005 Plan. This summary is based on the
federal tax laws in effect as of the date of this proxy
statement. This summary assumes that all awards are exempt from,
or comply with, the rules under Section 409A of the
Internal Revenue Code, as amended, or the Code, relating to
nonqualified deferred compensation. Changes to these laws could
alter the tax consequences described below.
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Incentive Stock Options. A participant will
not have income upon the grant of an incentive stock option.
Also, except as described below, a participant will not have
income upon exercise of an incentive stock option if the
participant has been employed by us or a 50% or more owned
corporate subsidiary at all times beginning with the option
grant date and ending three months before the date the
participant exercises the option. If the participant has not
been so employed during that time, then the participant will be
taxed as described below under Nonstatutory Stock
Options. The exercise of an incentive stock option may
subject the participant to the alternative minimum tax.
A participant will have income upon the sale of the stock
acquired under an incentive stock option at a profit (if sales
proceeds exceed the exercise price). The type of income will
depend on when the participant sells the stock. If a participant
sells the stock more than two years after the option was granted
and more than one year after the option was exercised, then all
of the profit will be long-term capital gain. If a participant
sells the stock prior to satisfying these waiting periods, then
the participant will have engaged in a disqualifying disposition
and a portion of the profit will be ordinary income and a
portion may be capital gain. This capital gain will be long-term
if the participant has held the stock for more than one year and
otherwise will be short-term. If a participant sells the stock
at a loss, meaning sales proceeds are less than the exercise
price, then the loss will be a capital loss. This capital loss
will be long-term if the participant held the stock for more
than one year and otherwise will be short-term.
Nonstatutory Stock Options. A participant will
not have income upon the grant of a nonstatutory stock option. A
participant will have compensation income upon the exercise of a
nonstatutory stock option equal to the value of the stock on the
day the participant exercised the option less the exercise
price. Upon sale of the stock, the participant will have capital
gain or loss equal to the difference between the sales proceeds
and the value of the stock on the day the option was exercised.
This capital gain or loss will be long-term if the participant
has held the stock for more than one year and otherwise will be
short-term.
Restricted Stock. A participant will not have
income upon the grant of restricted stock unless an election
under Section 83(b) of the Code is made within 30 days
of the date of grant. If a timely 83(b) election is made, then a
participant will have compensation income equal to the value of
the stock less the purchase price. When the stock is sold, the
participant will have capital gain or loss equal to the
difference between the sales proceeds and the value of the stock
on the date of grant. If the participant does not make an 83(b)
election, then when the stock vests the participant will have
compensation income equal to the value of the stock on the
vesting date less the purchase price. When the stock is sold,
the participant will have capital gain or loss equal to the
sales proceeds less the value of the stock on the vesting date.
Any capital gain or loss will be long-term if the participant
held the stock for more than one year and otherwise will be
short-term.
Other Stock-Based Awards. The tax consequences
associated with any other stock-based award granted under the
2005 plan will vary depending on the specific terms of such
award. Among the relevant factors are whether or not the award
has a readily ascertainable fair market value, whether or not
the award is subject to forfeiture provisions or restrictions on
transfer, the nature of the property to be received by the
participant under the award and the participants holding
period and tax basis for the award or underlying common stock.
Tax Consequences to NxStage. There will be no
tax consequences to us except that we will be entitled to a
deduction when a participant has compensation income. Any such
deduction will be subject to the limitations of
Section 162(m) of the Code.
OUR BOARD OF DIRECTORS RECOMMENDS A VOTE FOR THE
AMENDMENT TO THE 2005 PLAN
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The following is a description of the material aspects of the
Stock Purchase, including the stock purchase agreement. While we
believe that the following description covers the material terms
of the Stock Purchase, the description may not contain all of
the information that is important to you. We encourage you to
read carefully this entire proxy statement, including the stock
purchase agreement attached to this proxy statement as
Annex A, for a more complete understanding of the Stock
Purchase.
Background
of the Stock Purchase
Medisystems has been a significant supplier to NxStage since our
inception. Prior to 2005, Medisystems was the primary supplier
of components for our System One disposable cartridges. Since
2006, Medisystems has supplied the completed disposable
cartridge for our System One. Medisystems is wholly-owned by
Mr. Utterberg, a significant stockholder and director of
NxStage since 1999. Historically, our supply arrangement with
Medisystems was conducted on a purchase order basis. During
2006, we began negotiating a long-term supply agreement with
Medisystems for our disposable cartridges. We and Medisystems
entered into this long-term supply agreement on January 4,
2007.
In the course of negotiating the supply agreement, in late
December 2006, Mr. Utterberg approached our chief executive
officer, Jeff Burbank, about our possible acquisition of
Medisystems. On January 3, 2007, our board of directors
authorized Mr. Burbank to pursue preliminary discussions
pertaining to the possible acquisition of Medisystems.
Between January 5 and January 8, 2007, Mr. Burbank and
Mr. Licari, our chief operating officer, accompanied
Mr. Utterberg and Mr. Azel, the Medisystems vice
president of operations, on a facility tour of Medisystems
manufacturing facilities in Mexico and Italy.
In addition to the trips to Mexico and Italy, we conducted
preliminary financial and contractual due diligence using
materials supplied by Medisystems between January 6 and
January 22, 2007.
On January 23, 2007, at a meeting of the board of
directors, our management and the board of directors, excluding
Mr. Utterberg, discussed our possible acquisition of
Medisystems and reviewed the due diligence completed by our
management to date. Based on the information provided, our board
of directors discussed potential risks and benefits of the
proposed transaction, possible deal structures and next steps,
including engaging appropriate experts to assist in diligence
efforts, valuation estimates and deal structuring. It was agreed
that the board of directors should continue to have outside
counsel present for all discussions regarding a potential
transaction with Medisystems.
On January 30, 2007 at a meeting of the board of directors,
management reviewed with the board of directors, excluding
Mr. Utterberg, financial information received to date from
Medisystems and discussed Medisystems corporate structure,
business and financial position, as well as some of the risks
and benefits of a potential Medisystems acquisition. The board
of directors asked management to proceed with its evaluation of
Medisystems as a possible acquisition target and report to the
board of directors on its findings.
On February 5 and 6, 2007, Mr. Brown, our chief financial
officer of NxStage, went to Seattle to review the Medisystems
financial information and talk to members of the Medisystems
management team.
On February 7, 2007, Mr. Burbank and Mr. Brown
met with representatives of Merrill Lynch to discuss Medisystems
and Merrill Lynchs role as financial advisor to NxStage.
Between February 12, 2007 and February 23, 2007,
representatives of NxStage and Merrill Lynch engaged in a review
of financial information and development of financial
projections for a potential acquisition of Medisystems.
On February 26, 2007, at a special meeting of our board of
directors, excluding Mr. Utterberg, management and
representatives of Merrill Lynch continued discussions regarding
NxStages evaluation of a potential acquisition of
Medisystems. Representatives of Merrill Lynch reviewed their
analysis to date of a potential acquisition of Medisystems, and
they summarized business information learned to date about
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Medisystems, including historical sales performance and future
growth opportunities as well as certain business rationales for
acquiring Medisystems, including a broader product line, control
of System One cartridge manufacturing and possible acceleration
of profitability. Representatives of Merrill Lynch reviewed
their preliminary valuation analysis of a Medisystems
acquisition, including potential transaction structures. The
directors and management then discussed next steps and proposed
a future negotiation process with Merrill Lynch and management.
Management agreed to proceed according to the process discussed
and to report back to the board of directors.
On March 1, 2007, Mr. Burbank and James Boylan of
Merrill Lynch met with Mr. Utterberg in Seattle to deliver
a term sheet outlining our proposed terms for the transaction,
including the structure of the proposed transaction, the
consideration to be paid in the transaction and other terms and
conditions.
On March 7, 2007, Mr. Burbank and Mr. Boylan met
with Mr. Utterberg in Lawrence, Massachusetts to continue
discussions regarding the terms and conditions and possible
structure of a Medisystems acquisition, including the structure
of the proposed transaction, the type, amount, and timing, of
consideration to be paid in the transaction and the assets to be
acquired.
Between March 7 and March 16, 2007, our management and
Mr. Utterberg continued to negotiate terms and conditions
of a possible acquisition of Medisystems.
On March 26, 2007, Mr. Burbank, Mr. Brown and
Mr. Boylan met with Mr. Utterberg and Ann Kelly,
financial advisor to Mr. Utterberg, in Chicago to discuss
valuation of the Medisystems acquisition.
Between March 26 and April 13, 2007, the Company and
Mr. Utterberg continued to negotiate terms and conditions
of a possible acquisition of Medisystems, including the
structure of the proposed transaction, the type, amount, and
timing of consideration to be paid in the transaction and the
assets to be acquired and the terms of the consulting agreement
with Mr. Utterberg.
On April 13, 2007 at a special meeting of our board of
directors, excluding Mr. Utterberg, management and the
board discussed the summary of key business terms and strategic
rationale for a Medisystems acquisition. Management and the
board of directors reviewed certain preliminary financial
analyses of the proposed transaction and discussed different
structuring alternatives for the transaction. Management and the
board of directors then discussed the process for approving the
proposed acquisition, given its status as a related party
transaction. Pursuant to the requirements of the Audit Committee
Charter, the Audit Committee would be required to vote on all
related party transactions, and it was agreed that the Audit
Committee would follow a process substantially similar to the
process used in approving our supply agreement with Medisystems.
Following the conclusion of these discussions, management
reviewed the ongoing diligence efforts relating to the proposed
acquisition. At the conclusion of these discussions, members
agreed that management should continue to negotiate the proposed
acquisition of Medisystems according to the general terms
reviewed with the board of directors.
Between April 17 and April 20, 2007, Mr. Burbank and
Mr. Brown were in Seattle to meet with Mr. Utterberg
and Ms. Kelly to negotiate terms and conditions of the
acquisition and review financial information related to the
acquisition. Negotiations at this meeting focused primarily on
the timing of the consideration to be paid in the transaction,
the assets to be acquired in the transaction, the terms of an
on-going consulting agreement between the parties and what
restriction, if any, would be placed on any shares issued to
Mr. Utterberg as deal consideration.
On April 19, 2007 at a meeting of our board of directors,
excluding Mr. Utterberg, management and the board of
directors discussed proposed key business terms for the
acquisition and discussed how certain terms had changed from
those previously presented to the board of directors. Members
discussed the proposed deal structure at length, as well as
other key business terms. At the conclusion of these
discussions, members agreed that Mr. Burbank should
continue to negotiate the proposed acquisition of Medisystems
according to the general terms reviewed with the board of
directors.
On April 25, 2007, our Audit Committee met to discuss,
among other things, the status of ongoing diligence and
negotiations with Medisystems. On April 26, 2007, the same
information was shared with our
56
full board or directors, excluding Mr. Utterberg. Merrill
Lynch also presented information at this meeting regarding its
ongoing valuation analysis of Medisystems and its perceptions
regarding other deal terms, including the timing of deal
consideration and the assets being transferred.
Between April 26, 2007 and May 30, 2007, several
meetings of the Audit Committee were held to review the status
of due diligence efforts and ongoing negotiations as well as any
changes to key business terms arising in the course of ongoing
negotiations.
An initial draft of the stock purchase agreement was delivered
by our counsel, WilmerHale, to Medisystems and its counsel,
Arnold & Porter, on April 27, 2007. We received
Medisystems and its counsels preliminary comments to
the stock purchase agreement on May 1 and 2, 2007, and we
received a revised draft of the stock purchase agreement on
May 3, 2007. WilmerHale distributed a revised draft of the
stock purchase agreement to Medisystems and its counsel on
May 4th. Arnold & Porter delivered an issues list
in response to the revised draft on May 5, 2007, and the
parties participated in a conference call, with their respective
counsel, on May 6th to discuss the issues list.
Arnold & Porter distributed a revised draft of the
stock purchase agreement responsive to many of the matters
discussed in that conference call on May 7, 2007.
The parties, with their counsel, met in Boston, Massachusetts to
negotiate the stock purchase agreement on May 8th and
9th. WilmerHale distributed a revised draft of the stock
purchase agreement reflective of what the parties had agreed to
during these meetings on May 15, 2007. Arnold &
Porter delivered a draft response to the stock purchase
agreement on May 23, 2007. Mr. Burbank, our Chief
Executive Officer, delivered a revised draft of the stock
purchase agreement to Mr. Utterberg on May 25, 2007,
and Mr. Utterberg delivered a revised draft in response to
Mr. Burbank on May 27, 2007. Mr. Burbank
delivered further revised drafts of the stock purchase agreement
to Mr. Utterberg on May 29, 30 and 31, 2007.
Mr. Utterberg and Mr. Burbank exchanged revised drafts
of the stock purchase agreement to each other on May 31st.
On June 1, 2007, WilmerHale sent revisions to the stock
purchase agreement to Arnold & Porter, and
Arnold & Porter distributed a revised draft of the
stock purchase agreement to WilmerHale on the same day.
Arnold & Porter distributed additional changes to the
stock purchase agreement on June 2, 2007, and final changes
to the stock purchase agreement on June 4, 2007, the date
on which the stock purchase agreement was definitively approved
by our board of directors and signed by both parties.
During April and May 2007, representatives of NxStage and
Medisystems engaged in substantial due diligence in connection
with the proposed business combination, including financial,
intellectual property, regulatory and legal due diligence.
Outside experts were engaged to assist in these efforts.
Diligence reports from all outside experts were obtained and
shared with our Audit Committee and our full board of directors,
other than Mr. Utterberg.
On June 3 and 4, 2007, meetings of our Audit Committee and our
full board of directors, excluding Mr. Utterberg, were held
to review the final documents in detail as well as
managements recommendations with respect to the
transaction. Representatives of Merrill Lynch and WilmerHale
were present at these meetings. Merrill Lynch reviewed its final
analysis of the transaction and deal structure and delivered its
oral fairness opinion. Merrill Lynch also delivered its written
fairness opinion on June 4, 2007.
On June 4, 2007, our Audit Committee and our full board of
directors, excluding Mr. Utterberg, approved the Stock
Purchase and later that day, we executed the stock purchase
agreement and issued a press release announcing the Stock
Purchase.
Our
Reasons for the Stock Purchase
Our board of directors has determined that the terms of the
Stock Purchase and the stock purchase agreement are fair to, and
in the best interests of, NxStage and our stockholders. Our
board of directors consulted with senior management, as well as
legal counsel, and financial advisors in reaching its decision
to approve the Stock Purchase. Our board of directors considered
a number of factors in its deliberations, including the
following:
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historical information concerning NxStages and
Medisystems respective businesses, prospects, financial
performance and condition, operations, technology, management
and competitive position,
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including, without limitation, reports concerning results of
operations during the most recent fiscal year and fiscal quarter
for each corporation;
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our managements view of the financial condition, results
of operations and businesses of NxStage and Medisystems before
and after giving effect to the Stock Purchase;
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current financial market conditions and historical market
prices, volatility and trading information with respect to our
common stock;
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the relationship between the market value of our common stock
and the consideration to be paid by us in the Stock Purchase and
a comparison of comparable transactions;
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the terms of the stock purchase agreement, including the
parties representations, warranties and covenants, and the
conditions to their respective obligations;
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detailed financial analysis and pro forma and other information
with respect to the companies presented by Merrill Lynch in
presentations to the board of directors, including Merrill
Lynchs opinion that the consideration to be paid under the
stock purchase agreement is fair from a financial point of view
to our stockholders;
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reports from management, financial and tax advisors, independent
auditors, outside legal experts and others as to the results of
the due diligence investigation of Medisystems;
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the prices paid in comparable transactions involving other
medical device companies, as well as the trading performance for
comparable companies in the industry;
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beliefs shared by our senior management that the prospects of
the combined entity were more favorable than our prospects as a
separate entity, due to:
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the benefits associated with gaining manufacturing scale and
controlling the manufacture of our key disposable product;
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the benefits associated with an expanded product line;
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the belief that the transaction may accelerate our timeline to
profitability; and
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the belief that the transaction may enable us to accelerate the
development of additional products in the dialysis market.
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the cost of acquiring Medisystems disposable manufacturing
operations and leadership team compared to the time to
internally develop the same capabilities; and
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the interests of our officers and directors in the Stock
Purchase, including the matters described under The Stock
Purchase Interests of Mr. Utterberg in the
Stock Purchase on page 65 and the impact of the Stock
Purchase on our stockholders and employees, including the fact
that Mr. Utterberg is a member of our board of directors.
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Our board of directors also considered potential negative
factors relating to the Stock Purchase, including:
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the potential negative effect on our common stock price if
product development expectations for Medisystems are not met;
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the risk that the Medisystems business will not perform as
expected;
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the risk that the transaction will not accelerate our timeline
to profitability;
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the risk that the Medisystems StreamLine2 product will not
achieve commercial acceptance;
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the risk that the transaction will not result in the anticipated
cost savings;
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the risk that the Stock Purchase may not be completed in a
timely manner, if at all;
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the risk that we will be unable to retain and recruit employees
critical to the ongoing success of the combined companys
operations;
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the risk of adverse reactions of Medisystems customers and
vendors to the acquisition;
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the risk that the integration of the Medisystems business could
be more costly and time consuming than anticipated, which could
adversely affect the combined companys operating results
and preclude the achievement of benefits anticipated from the
Stock Purchase;
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the risk of Medisystems being acquired by another entity;
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the risk that our managements attention will be diverted
from other strategic and operational priorities to implement the
merger; and
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the other risks and uncertainties discussed above under
Risk Factors beginning on page 18
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The foregoing discussion of the items that our board of
directors considered is not intended to be exhaustive, but
includes all material items. In view of the complexity and wide
variety of factors, both positive and negative, that our board
of directors considered, our board of directors did not find it
practical to quantify, rank or otherwise weight the factors
considered. In considering the various factors, individual
members of our board of directors considered all of these
factors as a whole and concluded that, on balance, the benefits
of the Stock Purchase to NxStage and our stockholders outweighed
the risks.
Recommendation
of Our Board of Directors
After careful consideration, our board of directors, without
Mr. Utterberg, determined that the proposed Stock Purchase
is fair to, and in the best interests of, our company and
stockholders. Our board of directors recommends that our
stockholders vote FOR the issuance of our common
stock in the Stock Purchase.
In considering the recommendation of our board of directors with
respect to the Stock Purchase, our stockholders should be aware
that Mr. Utterberg has interests in the Stock Purchase and
the related transactions that are different from the interests
of our stockholders generally. See Interests of
Mr. Utterberg in the Stock Purchase beginning on
page 65.
Opinion
of NxStages Financial Advisor
Our board of directors retained Merrill Lynch to act as its
financial advisor in connection with the proposed Stock
Purchase. Merrill Lynch delivered its oral opinion to our board
of directors, which was subsequently confirmed in writing, that,
as of June 4, 2007, and based upon and subject to the
assumptions, qualifications and limitations set forth in its
written opinion (which are described below), the consideration
to be paid by us in connection with the Stock Purchase was fair,
from a financial point of view, to NxStage.
The full text of the written opinion of Merrill Lynch, dated
June 4, 2007, which sets forth the procedures followed,
assumptions made, matters considered and qualifications and
limitations on the review undertaken by Merrill Lynch, is
attached as Annex B to this proxy statement. The summary of
Merrill Lynchs opinion set forth below is qualified in its
entirety by reference to the full text of the opinion. Our
shareholders are urged to read the opinion carefully in its
entirety.
The Merrill Lynch opinion was addressed to our board of
directors for its use and benefit and only addresses the
fairness, from a financial point of view, as of the date of the
opinion, of the consideration to be paid by us in connection
with the Stock Purchase. The opinion does not address the merits
of our underlying decision to engage in the Stock Purchase and
does not constitute, nor should it be construed as, a
recommendation as to how any of our stockholders should vote
with respect to the proposed stock issuance or any other matter.
In addition, Merrill Lynch was not asked to address nor does its
opinion address the fairness to, or any other consideration of,
the holders of any class of securities, creditors or other
constituencies of ours.
In preparing its opinion to our board of directors, Merrill
Lynch performed various financial and comparative analyses,
including those described below. The summary set forth below
does not purport to be a complete description of the analyses
underlying Merrill Lynchs opinion or the presentation made
by Merrill Lynch to our board of directors. The preparation of a
fairness opinion is a complex analytic process involving
59
various determinations as to the most appropriate and relevant
methods of financial analysis and the application of those
methods to the particular circumstances and, therefore, a
fairness opinion is not readily susceptible to partial analysis
or summary description. In arriving at its opinion, Merrill
Lynch did not attribute any particular weight to any analysis or
factor considered by it, but rather made its determination as to
fairness on the basis of its experience and professional
judgment after considering the results of all of its analyses.
Accordingly, Merrill Lynch believes that its analyses must be
considered as a whole and that selecting portions of its
analyses and factors, or focusing on information presented in
tabular format, without considering all of the analyses and
factors or the narrative description of the analyses, would
create a misleading or incomplete view of the process underlying
its opinion.
In performing its analyses, Merrill Lynch made numerous
assumptions with respect to industry performance, general
business, economic, market and financial conditions and other
matters, many of which are beyond the control of Merrill Lynch,
us or the MDS Entities. Any estimates contained in the analyses
performed by Merrill Lynch are not necessarily indicative of
actual values or future results, which may be significantly more
or less favorable than those suggested by such analyses.
Additionally, estimates of the value of businesses or securities
do not purport to be appraisals or to reflect the prices at
which such businesses or securities might actually be sold.
Accordingly, such analyses and estimates are inherently subject
to substantial uncertainty. In addition, as described above,
Merrill Lynchs opinion was among several factors taken
into consideration by our board of directors in making its
determination to approve the stock purchase agreement and the
Stock Purchase. Consequently, Merrill Lynchs analyses
should not be viewed as determinative of the decision of our
board of directors to enter into the stock purchase agreement or
to engage in the Stock Purchase.
In arriving at its opinion, Merrill Lynch, among other things:
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reviewed certain publicly available business and financial
information relating to us that Merrill Lynch deemed to be
relevant;
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reviewed certain information, including financial forecasts,
relating to the business, earnings, cash flow, assets,
liabilities and prospects of us and Medisystems;
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conducted discussions with members of senior management of
Medisystems and NxStage concerning the matters described in the
preceding two bullet points, as well as their respective
businesses and prospects before and after giving effect to the
Stock Purchase;
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reviewed the market prices and valuation multiples for our
common stock and for certain publicly traded companies that
Merrill Lynch deemed to be relevant;
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reviewed the results of operations of Medisystems and compared
them with those of certain publicly traded companies that
Merrill Lynch deemed to be relevant;
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compared the proposed financial terms of the Stock Purchase with
the financial terms of certain other transactions that Merrill
Lynch deemed to be relevant;
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participated in certain discussions and negotiations among
representatives of Medisystems and NxStage and their financial
and legal advisors;
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reviewed the potential pro forma impact of the Stock Purchase on
our business;
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reviewed the stock purchase agreement, the license agreement
between DSU Medical Corporation and MDS, and the form of
consulting agreement to be entered into by and among us, DSU
Medical Corporation and Mr. Utterberg; and
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reviewed such other financial studies and analyses and took into
account such other matters as Merrill Lynch deemed necessary,
including its assessment of general economic, market and
monetary conditions.
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In preparing its opinion, Merrill Lynch assumed and relied on
the accuracy and completeness of all information supplied or
otherwise made available to it, discussed with or reviewed by or
for it, or that was
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publicly available. Merrill Lynch did not assume any
responsibility for independently verifying such information and
did not undertake any independent evaluation or appraisal of any
of the assets or liabilities of NxStage or Medisystems and it
was not furnished with any such evaluation or appraisal, nor did
it evaluate the solvency or fair value of NxStage or Medisystems
under any state or federal laws relating to bankruptcy,
insolvency or similar matters. In addition, Merrill Lynch did
not assume any obligation to conduct any physical inspection of
the properties or facilities of NxStage or Medisystems. With
respect to the financial forecast information furnished to or
discussed with Merrill Lynch by Medisystems or NxStage, Merrill
Lynch assumed that this information had been reasonably prepared
and reflected the best currently available estimates and
judgment of NxStages or Medisystems management as to
the expected future financial performance of NxStage or
Medisystems, as the case may be. Merrill Lynch expressed no
opinion as to such financial forecast information or the
assumptions on which it was based.
The opinion of Merrill Lynch is necessarily based upon market,
economic and other conditions as they existed and could be
evaluated on, and on the information made available to Merrill
Lynch as of, June 4, 2007, the date of its written opinion.
Merrill Lynch has no obligation to update its opinion to take
into account events occurring after the date that its opinion
was delivered to our board of directors. Circumstances could
develop prior to consummation of the Stock Purchase that, if
known at the time Merrill Lynch rendered its opinion, would have
altered its opinion.
Merrill Lynch assumed that in the course of obtaining the
necessary regulatory or other consents or approvals, contractual
or otherwise, for the Stock Purchase, no restrictions, including
any divestiture requirements or amendments or modifications,
will be imposed that will have a material adverse effect on the
contemplated benefits of the Stock Purchase. Merrill Lynch did
not express any opinion as to the prices at which our common
stock would trade following the announcement or the consummation
of the Stock Purchase. Although Merrill Lynch evaluated the
fairness, from a financial point of view, of the consideration,
Merrill Lynch was not requested to, and did not, recommend the
specific consideration payable in the Stock Purchase, which
consideration was determined through negotiations between us and
Mr. Utterberg and approved by our board of directors.
Merrill Lynch assumed that the representations and warranties of
each party contained in the stock purchase agreement were true
and correct as of June 4, 2007, the date of its written
opinion, that each party will perform all of its respective
covenants and agreements contained in the stock purchase
agreement and that the Stock Purchase will be consumed in
accordance with the terms of the stock purchase agreement
without waiver, modification or amendment. Merrill Lynch does
not render accounting, legal, tax or intellectual property
advice and understood that we were relying upon our own
accounting, legal, tax and intellectual property advisors as to
accounting, tax, legal and intellectual property matters in
connection with the Stock Purchase.
The following is a summary of the material analyses performed by
Merrill Lynch in connection with its opinion to our board of
directors dated June 4, 2007. Some of the financial
analyses summarized below include information presented in
tabular format. In order to understand fully Merrill
Lynchs financial analyses, the tables must be read
together with the text of the summary. The tables alone do not
constitute a complete description of the financial analyses.
Considering the data set forth below without considering the
full narrative description of the financial analyses, including
the methodologies and assumptions underlying the analyses, could
create a misleading or incomplete view of Merrill Lynchs
financial analyses.
Analysis of Selected Comparable Publicly Traded Companies.
Using publicly available information, Merrill Lynch compared
financial and operating information and ratios for Medisystems
with the corresponding information for a selected group of
publicly traded companies. Merrill Lynch selected these
companies because they engage in businesses and have operating
profiles reasonably similar to those of Medisystems. The
selected companies were:
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Greatbatch;
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Zoll Medical;
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61
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Cantel Medical;
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Medical Action Industries; and
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Microtek Medical.
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Merrill Lynch calculated an equity value for each of these
companies based on their respective closing share prices as of
June 1, 2007 and the number of shares, options and
convertible securities outstanding as reflected in publicly
available information. Using these equity values, Merrill Lynch
calculated an enterprise value for each company by adding to
these equity values the amount of each companys net debt,
preferred stock and minority interest as reflected in its most
recent publicly available balance sheet.
Using estimates of earnings before interest, taxes, depreciation
and amortization, or EBITDA, and earnings per share, or EPS, for
each of these companies derived from estimates published by
selected Wall Street research analysts, Merrill Lynch calculated
the following multiples for each company:
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Enterprise value as a multiple of revenue based on calendar year
2006 or CY 2006, revenue and calendar year 2007 and 2008, or CY
2007 and CY 2008, respectively, estimated revenues;
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Enterprise value as a multiple of EBITDA based on CY 2006 EBITDA
and CY 2007 and 2008 estimated EBITDA;
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Price/earnings, or P/E multiples, based on CY 2007 and 2008
estimated EPS and the closing share price as of June 1,
2007; and
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Price/earnings to growth, or PEG multiples, based on CY 2007 and
2008 estimated EPS, the closing share price as of June 1,
2007 and the Long-term EPS Growth Rate.
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Merrill Lynch also calculated similar implied multiples for us
using an enterprise value and a share price for us based on our
closing share price of $12.09 as of June 1, 2007, the last
trading day before the meeting of the board of directors at
which the board of directors approved the Stock Purchase and the
stock purchase agreement, and estimates of revenue reflected in
Wall Street research.
Merrill Lynch compared the maximum, mean, median and minimum
implied multiples it calculated for the comparable companies to
the implied multiples it calculated for us. The results of
Merrill Lynchs comparison are reflected in the following
table:
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CY 2006
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CY 2007E
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CY 2008E
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CY 2006
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CY 2007E
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CY 2008E
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Revenue
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Revenue
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Revenue
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EBITDA
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EBITDA
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EBITDA
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CY 2007E
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CY 2008E
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CY 2007E
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CY 2008E
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Multiple
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Multiple
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Multiple
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Multiple
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Multiple
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Multiple
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P/E Multiple
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P/E Multiple
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PEG
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PEG
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Maximum
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2.65x
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2.34x
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2.12x
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13.2x
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10.8x
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8.5x
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27.0x
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22.2x
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2.07x
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1.71x
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Mean
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1.69x
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1.44x
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1.61x
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11.9x
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9.5x
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8.2x
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23.2x
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18.4x
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1.50x
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1.33x
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Median
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1.43x
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1.20x
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1.61x
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11.9x
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9.4x
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8.2x
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21.6x
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17.5x
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1.38x
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1.30x
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Minimum
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1.34x
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1.06x
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1.09x
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10.8x
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7.9x
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8.0x
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20.2x
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16.8x
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1.17x
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0.97x
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NxStage
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15.06x
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7.13x
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3.55x
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NA
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NA
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NA
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NA
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NA
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NA
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NA
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Based on the foregoing and Merrill Lynchs analyses of the
various comparable companies and on qualitative judgments
involving non-mathematical considerations, Merrill Lynch applied
multiples ranging from:
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1.35x to 1.65x to the fiscal 2006 revenue and calculated implied
enterprise values for Medisystems ranging from $89 million
to $109 million as compared to the $79 million
transaction value;
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11.0x to 13.0x to the fiscal 2006 EBITDA and calculated implied
enterprise values for Medisystems ranging from $83 million
to $98 million as compared to the $79 million
transaction value;
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1.10x to 1.50x to our managements estimates of fiscal 2007
revenue and calculated implied enterprise values for Medisystems
ranging from $79 million to $107 million based on the
fiscal 2007 revenue estimate derived from the management
projections as compared to the $79 million transaction
value; and
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62
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8.0x to 11.0x to our managements estimates of fiscal 2007
EBITDA and calculated implied enterprise values for Medisystems
ranging from $110 million to $151 million based on the
fiscal 2007 EBITDA estimate derived from the management
projections as compared to the $79 million transaction
value.
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None of the selected comparable companies is identical to
Medisystems. Accordingly, a complete analysis of the results of
the foregoing calculations cannot be limited to a quantitative
review of the results and involves complex considerations and
judgments concerning differences in financial and operating
characteristics of the selected comparable companies and other
factors that could affect the public trading dynamics of the
selected comparable companies.
Analysis of Selected Comparable
Acquisitions. Using publicly available
information, Merrill Lynch calculated the multiple of revenue
and EBITDA for Medisystems reflected by the transaction value of
each of the transactions listed below.
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Date Announced
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Acquiror
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Target
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4/30/2007
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Greatbatch
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Enpath Medical
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6/30/2006
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Blackstone Group
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Encore Medical
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4/20/2006
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Integra LifeSciences
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Miltex, Inc.
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3/8/2006
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Philips
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Witt Biomedical
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2/27/2006
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Orthopedics, Inc.
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Aircast Inc.
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2/21/2006
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Coherent
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Excel Technology
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9/7/2005
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Integra LifeSciences
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Radionics
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6/16/2005
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Gyrus Corp
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ACMI Corp
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1/18/2005
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Elekta AB
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Impac Medical Systems
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8/9/2004
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Encore Medical
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Empi, Inc.
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Merrill Lynch calculated the transaction value for each
transaction by multiplying the amount of the announced per share
consideration paid or payable in each transaction by the number
of fully-diluted outstanding shares of the target company based
upon publicly available information and adding to the result the
amount of the companys net debt as of the date of the
target companys most recent balance sheet prior to
announcement of the transaction.
For each of the transactions, Merrill Lynch calculated the
transaction value as a multiple of revenue and EBITDA for the
most recently reported 12 months prior to the date of
announcement of the transaction, which we refer to as the LTM
Revenue Multiple and the LTM EBITDA Multiple. The average LTM
Revenue Multiple for all the transactions was 2.46x and the
average LTM EBITDA Multiple for all the transactions, was 14.2x.
Based on the foregoing and Merrill Lynchs analyses of the
various transactions and on qualitative judgments involving
non-mathematical considerations, Merrill Lynch applied multiples
ranging from:
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1.60x to 2.60x to the revenue for the last 12 months as of
March 31, 2007 and calculated implied enterprise values for
Medisystems ranging from $106 million to $173 million
as compared to the $79 million transaction value; and
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9.0x to 18.0x to the LTM EBITDA as of March 31, 2007 to
derive a range of implied enterprise values for Medisystems and
calculated implied enterprise values for Medisystems ranging
from $77 million to $154 million as compared to the
$79 million transaction value.
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None of the transactions analyzed by Merrill Lynch is identical
to the proposed transaction. Accordingly, a complete analysis of
the results of the foregoing calculations cannot be limited to a
quantitative review of the results and involves complex
considerations and judgments concerning differences in financial
and operating characteristics of the companies party to those
transactions as well as the transactions and other factors that
could affect the proposed Stock Purchase.
63
Discounted Cash Flow Analysis. Merrill Lynch
performed a discounted cash flow analysis of the estimated free
cash flows of Medisystems business (exclusive of its
contract with us described below) reflected in the management
projections. Merrill Lynch also performed a discounted cash flow
analysis of the estimated free cash flows expected to be derived
from the contract between Medisystems and us pursuant to which
Medisystems has agreed to provide disposable cartridges to us
for a seven-year term reflected in the management projections.
In performing its discounted cash flow analysis of
Medisystems business (exclusive of our contract with
Medisystems), Merrill Lynch calculated ranges of the present
value as of June 30, 2007 of the estimated free cash flows
of Medisystems business (exclusive of our contract with
Medisystems) over the period from the third quarter of 2007
through fiscal 2014 by applying discount rates ranging from
12.5%-15.0% to those estimates. In addition, Merrill Lynch
calculated ranges of the present value as of June 30, 2007
of the estimated Terminal Value of the Medisystems
business (exclusive of our contract with Medisystems), based on
applying a perpetuity growth rate of 0.0% to the fiscal 2014
free cash flow and applying discount rates ranging from
12.5%-15.0%. In performing its discounted cash flow analysis of
our contract with Medisystems, Merrill Lynch calculated ranges
of the present value as of June 30, 2007 of the estimated
free cash flows of our contract with Medisystems over the period
from the third quarter of 2007 through fiscal 2014 by applying
discount rates ranging from 15.0%-17.5%. No Terminal Value was
calculated for our contract with Medisystems because the
agreement exists for a finite period of seven years.
Merrill Lynch added together the net present value ranges as of
June 30, 2007 that it derived for Medisystems
business (exclusive of the NxStage Contract) and for our
contract with Medisystems. Based upon the foregoing, Merrill
Lynch calculated an implied net present value of the estimated
future cash flows of Medisystems ranging from $126 million
to $150 million as compared to the $79 million
transaction value.
The discount rates utilized in these analyses were based on
Merrill Lynchs estimates of the weighted average cost of
capital of both Medisystems and us, based on its review of
publicly available business and financial information of
Medisystems and us, and the respective business and financial
characteristics of comparable companies, respectively. In
performing its weighted average cost of capital analysis of
Medisystems, Merrill Lynch compared financial and business
characteristics of comparable mature, steady growth medical
device companies. In performing its weighted average cost of
capital analysis of NxStage, Merrill Lynch compared financial
and business characteristics of comparable high growth medical
device companies.
Pro Forma Stock Purchase Analysis. Merrill
Lynch analyzed the pro forma impact of the proposed Stock
Purchase on our EPS for the fiscal years ending
December 31, 2007, 2008, 2009, 2010 and 2011. For purposes
of this analysis Merrill Lynch used the financial information
and projections provided by our management. Based on this
analysis, Merrill Lynch concluded that the proposed Stock
Purchase would be accretive to our EPS in 2007 and subsequent
years.
Other Factors. In the course of
preparing its opinion, Merrill Lynch also reviewed and
considered other information and data, including the following:
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our trading characteristics;
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historical market prices for our common stock;
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our financial, operating and stock market data and selected
publicly traded companies in the specialty medical technology
industry; and
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selected research analysts reports on NxStage, including stock
price estimates of those analysts.
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General. Merrill Lynch is an internationally
recognized investment banking and advisory firm. As part of its
investment banking business, Merrill Lynch is continuously
engaged in the valuation of businesses and securities in
connection with mergers and acquisitions, negotiated
underwritings, competitive biddings, secondary distributions of
listed and unlisted securities, private placements and
valuations for corporate and other purposes. The board of
directors selected Merrill Lynch as its financial adviser
because of Merrill Lynchs qualifications, expertise and
reputation.
64
Under the terms of its engagement, we have agreed to pay Merrill
Lynch a fee for its services, which is contingent upon the
consummation of the Stock Purchase. In addition, we have agreed
to reimburse Merrill Lynch for its reasonable out-of-pocket
expenses incurred in connection with providing its services and
to indemnify Merrill Lynch, its affiliates and related parties
against certain liabilities arising out of Merrill Lynchs
engagement.
Merrill Lynch has, in the past, provided financial advisory and
financing services to us and our affiliates and may continue to
do so and has received, and may receive, fees for the rendering
of such services. In addition, in the ordinary course of its
business, Merrill Lynch may actively trade our common stock and
our other securities for its own account and for the accounts of
customers and, accordingly, may at any time hold a long or short
position in such securities.
Interests
of Mr. Utterberg in the Stock Purchase
When considering the recommendation of our board of directors,
you should be aware that Mr. Utterberg, a NxStage director,
has interests in the Stock Purchase that are different from
yours. Mr. Utterberg owns, directly or indirectly, all of
the equity interests that we are purchasing in the MDS Entities.
Accordingly, Mr. Utterberg will receive
6,500,000 shares of our common stock, subject to a
post-closing working capital adjustment, if the Stock Purchase
is approved and completed. As a result,
Mr. Utterbergs aggregate ownership of our outstanding
stock will increase to approximately 23.4% of our outstanding
common stock if he receives 6,500,000 shares. As of
June 4, 2007, the last trading day prior to the
announcement of the Stock Purchase, the aggregate market value
of the 6,500,000 shares of common stock issuable to
Mr. Utterberg was $78.7 million, based on a per share
price of $12.11, which was the last sales price of our common
stock on the NASDAQ Global Market on that day.
We have agreed that following the Stock Purchase,
Mr. Utterberg will have piggyback registration
rights if we propose to register shares of our common stock
under the Securities Act of 1933, as amended. We will provide
Mr. Utterberg with notice of a registration of our shares
and provide Mr. Utterberg with the opportunity to include
the shares he received in the Stock Purchase in the
registration, subject to certain cut back and lock-up
restrictions. In addition, we have agreed to register for resale
the shares issued to Mr. Utterberg as consideration for the
Stock Purchase in the event that he ceases to be an affiliate of
NxStage prior to the time the holding period under
Rule 144(k) lapses as to such shares.
Additionally, in connection with the Stock Purchase we will
enter into a two-year consulting agreement with
Mr. Utterberg. Under the consulting agreement,
Mr. Utterberg will receive aggregate payments from us of
$200,000 per year, plus expenses. The terms of the consulting
agreement are more fully detailed in this proxy statement under
the heading License Agreement and Consulting
Agreement beginning on page 75.
Following the Stock Purchase, Mr. Utterberg will continue
to serve on our board of directors. In addition, the stock
purchase agreement provides that, if Mr. Utterberg is no
longer a director of NxStage, our board of directors will
nominate for election to our board any director nominee proposed
by Mr. Utterberg, subject to certain conditions.
Our board of directors took into account these interests in
considering whether to approve the Stock Purchase.
Mr. Utterberg did not participate in discussions held by
our board of directors concerning these transactions, nor did he
participate in the board votes authorizing these transactions.
Our
Current Relationship with Mr. Utterberg
Currently, Medisystems supplies the completed disposable
cartridges used with our System One product. We purchased
approximately $4.6 million of goods and services during
fiscal 2006 from Medisystems. In January 2007, we entered into a
seven-year agreement with Medisystems pursuant to which
Medisystems will supply to us no less than 90% of our North
American requirements for disposable cartridges for use with the
System One. If the Stock Purchase is approved by our
stockholders, following the closing we intend to terminate this
supply agreement.
65
We will not acquire patents in connection with the Stock
Purchase. All patented intellectual property presently used in
connection with the business of the MDE Entities is licensed by
MDS from DSU under a perpetual, royalty-free, fully paid license
agreement entered into between the parties on June 1, 2007.
For a description of the license agreement, see License
Agreement and Consulting Agreement on page 75.
Stock
Purchase Consideration
Base
Purchase Price
Upon the closing of the Stock Purchase, we will issue
Mr. Utterberg 6,500,000 shares of our common stock.
The total number of shares payable by us to Mr. Utterberg
is also subject to a post-closing working capital adjustment as
discussed below.
Working
Capital Adjustment Following Closing
Following the closing of the Stock Purchase, we and
Mr. Utterberg will determine the amount of working capital
held by the MDS Entities as of the closing. We and
Mr. Utterberg have agreed to a targeted working capital
amount as of closing equal to negative $1,850,000, which amount
will be increased by the sum of the amount of Medisystems
net income, plus depreciation and amortization for the period
from January 1, 2007 through the closing of the Stock
Purchase, and decreased by the sum of the amounts of
(1) the royalties payable under the license agreement
between MDS and DSU, described below, (2) cash dividends
equal to $55,000 per month for each month from January 1,
2007 through the closing of the Stock Purchase, (3) cash
dividends payable to Mr. Utterberg pursuant to the stock
purchase agreement for reimbursement of tax liability with
respect to Medisystems and (4) the amount of
Medisystems capital expenditures permitted under the terms
of the stock purchase agreement for the period from
January 1, 2007 through the closing of the Stock Purchase.
The base purchase price payable by us to Mr. Utterberg will
be adjusted depending on whether the amount of working capital
at closing is greater than or less than this targeted working
capital amount by $250,000 or more. The amount of the working
capital adjustment will not be known until at least 60 days
following the closing and, therefore, the total amount of the
shares of our common stock to be paid to Mr. Utterberg will
not be known until following the closing.
Escrow
Arrangements
At the closing of the Stock Purchase, 1,000,000 of the
6,500,000 shares payable by us to Mr. Utterberg will
be placed into escrow to cover potential indemnification claims
we may have against Mr. Utterberg. The escrow fund will
have a duration of two years following the closing of the Stock
Purchase, with 500,000 shares released after the first
year. For further information about the parties respective
indemnification obligations, see The Stock Purchase
Agreement Indemnification beginning on
page 74.
Lien
on Medisystems Assets
All of the assets held by the MDS Entities are currently subject
to a lien. In January 2003, the Medisystems Group entered into a
credit agreement with KeyBank National Association, pursuant to
which all of the assets of each Medisystems Group company have
been pledged as collateral. The credit agreement provides for a
$3.5 million revolving line of credit and a
$1.5 million demand line of credit. As of July 25,
2007, there were no amounts outstanding under the revolving line
of credit and Medisystems Group had issued approximately
$812,000 of standby letters of credit. We expect that at or
prior to the closing of the Stock Purchase, any surviving
obligations against the Medisystems Groups credit
commitments will be resolved by Medisystems and the credit
commitments, other than the currently issued KeyBank letters of
credit, which are securing guarantees of VAT refunds made to MDS
Italy by one of the Italian banks. Medisystems has indicated
that it will amend the KeyBank credit commitment prior to the
closing of the Stock Purchase to remove from the commitment the
Medisystems Group companies that we are not acquiring. However,
removal of these entities from the KeyBank credit commitment is
not within our control and is not a condition to closing.
66
Medisystems Group companies that are not MDS Entities may borrow
under the credit facility, and, if they default on any such
obligation, we could be required to satisfy their obligations.
Effective
Time of the Stock Purchase
The closing of the Stock Purchase shall occur, and the Stock
Purchase shall be effective, no later than two business days
after the satisfaction or waiver of all the conditions and the
obligations of NxStage and Mr. Utterberg to the
transactions contemplated by the stock purchase agreement,
including approval of the issuance of shares of NxStage common
stock to Mr. Utterberg by our stockholders.
We are not aware of any governmental or regulatory approval
required for completion of the Stock Purchase, other than
compliance with the Hart-Scott Rodino Act, compliance with
applicable corporate laws of Delaware, compliance with state
securities laws and the filing with the NASDAQ Global Market of
a Notification Form for Listing Additional Shares and a
Notification Form for Change in the Number of Shares
Outstanding, with respect to the shares of our common stock to
be issued to Mr. Utterberg pursuant to the stock purchase
agreement.
If any other governmental approvals or actions are required, we
intend to try to obtain them. We cannot assure you, however,
that we will be able to obtain any such approvals or actions.
U.S.
Federal Income Tax Consequences
No gain or loss will be recognized by us or by holders of shares
of our common stock as a result of the Stock Purchase.
With respect to the shares of common stock issuable as
consideration for the Stock Purchase, we have agreed with
Mr. Utterberg to file with the NASDAQ Global Market a
Notification Form for Listing Additional Shares and a
Notification Form for Changes in the Number of Shares
Outstanding.
Restrictions
on the Resale of the Stock Purchase Shares
Mr. Utterberg has agreed to certain resale restrictions on
the Stock Purchase Shares. Notably, he may not sell or otherwise
dispose of shares of our common stock acquired by him in short
sales or in trades to a single party exceeding
250,000 shares, without our prior written consent. These
restrictions will apply to the shares of our common stock
acquired by Mr. Utterberg until the earlier of (1) a
change in control of NxStage and (2) two years following
the closing of the Stock Purchase.
In addition, Mr. Utterberg is currently a director of
NxStage and, therefore, subject to the volume limitation on
resales pursuant to Rule 144. Mr. Utterberg will
continue to be subject to such restrictions for as long as he is
a director
and/or
affiliate of NxStage.
We have agreed that following the Stock Purchase,
Mr. Utterberg will have piggyback registration
rights if we propose to register shares of our common stock
under the Securities Act of 1933, as amended. We will provide
Mr. Utterberg with notice of a registration of our shares
and provide Mr. Utterberg with the opportunity to include
the shares he received in the Stock Purchase in the
registration, subject to certain cut back and lock-up
restrictions. In addition, we have agreed to register for resale
the shares issued to Mr. Utterberg as consideration for the
Stock Purchase in the event that he ceases to be an affiliate of
NxStage prior to the time the holding period under
Rule 144(k) lapses as to such shares.
67
THE STOCK
PURCHASE AGREEMENT
The following is a summary of the material terms of the stock
purchase agreement, which is attached as Annex A to this
proxy statement and is incorporated herein by reference. The
stock purchase agreement has been attached to this document to
provide you with information regarding its terms. It is not
intended to provide any other factual information about us,
Mr. Utterberg or the MDS Entities. The following
description does not purport to be complete and is qualified in
its entirety by reference to the stock purchase agreement. You
should refer to the full text of the stock purchase agreement
for details of the Stock Purchase and the terms and conditions
of the stock purchase agreement.
General
Under the stock purchase agreement, we will acquire from
Mr. Utterberg:
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all of the issued and outstanding shares of MDS;
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all of the issued and outstanding shares of MDS Services;
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90% the issued and outstanding shares of MDS Italy (the
remaining equity of which is held by MDS); and
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0.273% of the issued and outstanding equity participation of MDS
Mexico (the remaining equity of which is held by MDS).
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The closing of the Stock Purchase will occur no later than the
second business day after the last of the conditions to the
Stock Purchase have been satisfied or waived, or at another time
as the parties mutually agree. However, because the Stock
Purchase is subject to a number of conditions, we cannot predict
exactly when the closing will occur or if it will occur at all.
Stock
Purchase Consideration and Adjustment
At the closing of the Stock Purchase, Mr. Utterberg will
receive 6,500,000 shares of our common stock as
consideration for the Stock Purchase. Following the closing of
the Stock Purchase, we and Mr. Utterberg will work to
determine the amount of working capital held by the MDS Entities
as of the closing. We and Mr. Utterberg have agreed to a
targeted working capital amount as of closing equal to negative
$1,850,000, subject to adjustment as provided in the stock
purchase agreement. The base purchase price payable by us to
Mr. Utterberg will be adjusted depending on whether the
amount of working capital at closing is greater than or less
than this targeted working capital amount by $250,000 or more.
The amount of the working capital adjustment will not be known
until at least 60 days following the closing and,
therefore, the total amount of the shares of our common stock to
be paid to Mr. Utterberg will not be known until following
the closing.
Conditions
to the Completion of the Stock Purchase
Each partys obligation to complete the Stock Purchase is
subject to the satisfaction or waiver by each of the parties, at
or prior to the closing, of various conditions, which include
the following:
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all applicable waiting periods, and any extensions thereof,
under the
Hart-Scott-Rodino
Act will have expired or otherwise been terminated;
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each party will have obtained all of the waivers, permits,
consents, approvals or other authorizations, and effected all of
the registrations, filings and notices, required on the part of
each party in the stock purchase agreement;
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certain of the representations and warranties by the other party
in the stock purchase agreement, and any representations and
warranties by the other party set forth in the stock purchase
agreement that are qualified as to materiality will be true and
correct in all respects, and all other representations and
warranties of the other party set forth in the stock purchase
agreement will be true and correct in all material respects, in
each case as of the date of the stock purchase agreement and as
of the date of the closing as though made as of the date of the
closing, except to the extent such representations and
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warranties are specifically made as of a particular date (in
which case such representations and warranties will be true and
correct as of such date);
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the other party will have performed or complied with the
agreements and covenants required to be performed or complied
with in the stock purchase agreement as of or prior to the
closing;
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no legal proceeding will be pending or threatened in writing
wherein an unfavorable judgment, order, decree, stipulation or
injunction would (1) prevent consummation of the
transactions contemplated by the stock purchase agreement,
(2) cause the transactions contemplated by the stock
purchase agreement to be rescinded following consummation or
(3) have, individually or in the aggregate, a material
adverse effect, and no such judgment, order, decree, stipulation
or injunction will be in effect;
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the parties will have received (1) a duly executed escrow
agreement; and (2) a duly executed consulting
agreement; and
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each party will have delivered the documents required under the
stock purchase agreement for the closing, including good
standing certificates and certificates from certain officers.
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Our obligation to complete the Stock Purchase is subject to the
satisfaction or waiver, at or prior to the Stock Purchase, of
various additional conditions, which include the following:
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our stockholders will have approved the issuance of shares of
our common stock to Mr. Utterberg pursuant to the terms of
the stock purchase agreement;
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we will have received the financial statements, information and
other documents required to be provided by the stock purchase
agreement;
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Mr. Utterberg will have caused each MDS Entity to hold a
meeting of its stockholder(s) to approve the resignation of the
outgoing directors and officers of each respective MDS Entity
and the appointment of incoming directors and officers, as
specified by us, effective as of the closing; and
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we will have received copies of the resignations, effective as
of the closing, of each director and officer (in the case of MDS
Italy, this will include the board of statutory auditors), of
each of the MDS Entities, and such other documentation that may
be required under relevant local law or reasonably requested by
NxStage to implement the resignation of the outgoing directors
and officers and the appointment of the incoming directors and
officers, including full waivers from the outgoing directors
releasing the MDS Entities from any claims.
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Mr. Utterbergs obligation to complete the Stock
Purchase is subject to the satisfaction or waiver, at or prior
to the Stock Purchase, of various additional conditions, which
include the following:
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NxStage will have filed with NASDAQ (1) a notification form
for listing of additional shares and (2) a notification
form for change in the number of shares outstanding, with
respect to the shares of our common stock issuable pursuant to
the terms of stock purchase agreement.
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No
Solicitation
Mr. Utterberg has agreed he will not, and will cause each
of the MDS Entities not to, and will cause each of the MDS
Entities to require each of its officers, directors, employees,
representatives and agents not to, directly or indirectly:
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initiate, solicit, encourage or otherwise facilitate any
inquiry, proposal, offer or discussion with any party (other
than NxStage) concerning any merger, reorganization,
consolidation, recapitalization, business combination,
liquidation, dissolution, share exchange, sale of stock, sale of
material assets or similar business transaction involving any of
the MDS Entities or any division of any of the MDS Entities;
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furnish any non-public information concerning the business,
properties or assets of any of the MDS Entities or any division
of any of the MDS Entities to any party (other than
NxStage); or
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engage in discussions or negotiations with any party (other than
NxStage) concerning any such transaction.
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Mr. Utterberg has also agreed to, and to cause each of the
MDS Entities to, immediately notify any party with which
discussions or negotiations of the nature described above were
pending that Mr. Utterberg or the MDS Entities, as the case
may be, is terminating such discussions or negotiations. If
Mr. Utterberg or any of the MDS Entities receives any
inquiry, proposal or offer of the nature described above,
Mr. Utterberg has agreed to, or cause the MDS Entities to,
as the case may be, to, within one business day after receipt,
notify us of such inquiry, proposal or offer, including the
identity of the other party and the terms of the inquiry,
proposal or offer.
Meeting
of Stockholders
We are obligated under the stock purchase agreement to hold and
convene a special meeting of our stockholders for purposes of
considering the issuance of the Stock Purchase Shares. We are
required to prepare and file a proxy statement with the SEC and
distribute it to our stockholders for the purpose of convening
the special meeting and obtaining stockholder approval.
Covenants,
Conduct of Business Pending the Stock Purchase
Mr. Utterberg has agreed to cause each of the MDS Entities
to conduct its operations in the ordinary course of business and
in compliance with all applicable laws and regulations and, to
the extent consistent therewith, use its reasonable best efforts
to preserve intact its current business organization, keep its
physical assets in good working condition, keep available the
services of its current officers and employees and preserve its
relationships with customers, suppliers and others having
business dealings with it to ensure that its goodwill and
ongoing business will not be impaired in any material respect.
Prior to the closing, Mr. Utterberg has agreed to prevent
each of the MDS Entities from doing any of the following without
our written consent:
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issue or sell any stock, or equity participation or other
securities of any MDS Entity or any options, warrants or rights
to acquire any such stock, or equity participation or other
securities, or repurchase or redeem any stock, or equity
participation or other securities of any MDS Entity;
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split, combine or reclassify any shares of or equity
participation in its capital stock; or declare, set aside or pay
any dividend or other distribution (whether in cash, stock or
property or any combination thereof) in respect of its capital
stock;
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create, incur or assume any indebtedness (including obligations
in respect of capital leases); assume, guarantee, endorse or
otherwise become liable or responsible (whether directly,
contingently or otherwise) for the obligations of any other
person or entity; or make any loans, advances or capital
contributions to, or investments in, any other person or entity;
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enter into, adopt or amend any employee benefit plan or any
employment or severance agreement or arrangement described in
the stock purchase agreement or (except for normal increases in
the ordinary course of business for employees who are not
affiliates) increase in any manner the compensation or fringe
benefits of, or materially modify the employment terms of, its
directors, officers or employees, generally or individually, or
pay any bonus or other benefit to its directors, officers or
employees (except for certain existing payment obligations set
forth in the stock purchase agreement) or hire any new officers
or (except in the ordinary course of business) any new employees;
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acquire, sell, lease, license or dispose of any assets or
property (including any shares or other equity interests in or
securities of any subsidiary or any corporation, partnership,
association or other business organization or division thereof),
other than purchases and sales of assets in the ordinary course
of business;
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mortgage or pledge any of its property or assets or subject any
property or assets to any security interest;
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discharge or satisfy any security interest or pay any obligation
or liability other than in the ordinary course of business;
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amend its charter, bylaws or other organizational documents;
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change its accounting methods, principles or practices, except
as may be required by a generally applicable change in GAAP or
make any new elections, or changes to any current elections,
with respect to taxes;
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enter into, amend, terminate, take or omit to take any action
that would constitute a violation of or default under, or waive
any rights under, any contract or agreement of a nature
described in the stock purchase agreement;
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make or commit to make any capital expenditure in excess of
$10,000 per item or $50,000 in the aggregate, other than amounts
set forth in the capital budget of the MDS Entities for 2007;
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institute or settle any legal proceeding;
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take any action or fail to take any action permitted by the
stock purchase agreement with the knowledge that the action or
failure to take action would result in (1) any of the
representations and warranties of Mr. Utterberg set forth
in stock purchase agreement becoming untrue or (2) certain
conditions set forth in the stock purchase agreement not being
satisfied; or
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agree in writing or otherwise to take any of the above actions.
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Other
Agreements
We and Mr. Utterberg have agreed to use reasonable best
efforts to:
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take all actions necessary to complete the Stock Purchase;
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obtain all waivers, permits, consents, approvals or
authorizations from governmental entities required in connection
with the transactions; and
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effect all registrations, filings and notices with or to
governmental entities required in connection with the
transactions.
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We and Mr. Utterberg have agreed that:
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Mr. Utterberg will use reasonable best efforts to obtain
all waivers, consents or approvals from third parties and give
all notices to third parties as specified in the stock purchase
agreement;
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Mr. Utterberg will cause each of the MDS Entities to
provide us with access to certain information relating to the
MDS Entities;
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Mr. Utterberg will cause the MDS Entities to provide
information and otherwise assist in the preparation of certain
financial statements relating to the MDS Entities and us;
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Each party will provide the other with notice of any changes
that would make the representations and warranties untrue or
inaccurate, cause a breach of any covenant, or cause a material
adverse effect on the MDS Entities or us, respectively;
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We will make certain filings with NASDAQ to list the shares of
our common stock issued to Mr. Utterberg in connection with
the Stock Purchase;
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Mr. Utterberg will cause the MDS Entities to satisfy
certain obligations and liabilities identified in the stock
purchase agreement;
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Mr. Utterberg and his affiliates will maintain in
confidence certain information about the MDS Entities;
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Mr. Utterberg will not solicit or hire former employees of
the MDS Entities for two years following the closing;
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Mr. Utterberg will be subject to certain restrictions on
resale of shares of our common stock after the Stock Purchase;
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Mr. Utterberg will be restricted from acquiring additional
shares of our common stock for two years following the closing;
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Mr. Utterberg will have certain director nomination rights
after he completes his service on our board of directors;
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We will maintain and provide for certain matters relating to
employees and employee benefit plans;
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We will acquire and maintain product liability insurance
relating to the MDS Entities products for six years
following the closing; and
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We will continue to honor certain indemnification rights of the
MDS Entity directors and officers for six years following the
closing.
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We have agreed that following the Stock Purchase,
Mr. Utterberg will have piggyback registration
rights if we propose to register shares of our common stock
under the Securities Act of 1933, as amended. We will provide
Mr. Utterberg with notice of a registration of our shares
and provide him with the opportunity to include the shares he
received in the Stock Purchase in the registration, subject to
certain cut back and lock-up restrictions. In addition, we have
agreed to register for resale the shares issued to
Mr. Utterberg as consideration for the Stock Purchase in
the event he ceases to be an affiliate of NxStage prior to the
time the holding period under Rule 144(k) lapses as to such
shares.
The stock purchase agreement may be terminated at any time prior
to the closing, whether before or after we have obtained
stockholder approval:
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by mutual written consent of us and Mr. Utterberg;
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by us by giving written notice to Mr. Utterberg in the
event he is in breach of any representation, warranty or
covenant contained in the stock purchase agreement, and such
breach (1) individually or in combination with any other
such breach, would cause certain conditions not to be satisfied
and (2) is not cured within 20 days following delivery
by us to Mr. Utterberg of written notice of such breach;
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by Mr. Utterberg by giving written notice to us in the
event we are in breach of any representation, warranty or
covenant contained in the stock purchase agreement, and such
breach (1) individually or in combination with any other
such breach, would cause certain conditions not to be satisfied
and (2) is not cured within 20 days following delivery
by Mr. Utterberg to us of written notice of such breach;
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by either us or Mr. Utterberg by giving written notice to
the other party at any time after our stockholders have voted on
whether to approve the issuance of our common stock in the event
the proposed issuance of our common stock failed to receive the
approval of our stockholders; or
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by either of us by giving written notice to the other if the
closing will not have occurred on or before December 31,
2007 by reason of the failure of any condition precedent
required by the stock purchase agreement (unless the failure
results primarily from a breach of any representation, warranty
or covenant contained in the stock purchase agreement by the
party providing notice).
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Expenses
and Reimbursement
If the stock purchase agreement is terminated as a result of our
board of directors decision to modify or withdraw its
recommendation to our stockholders, we agree to reimburse
Mr. Utterberg up to $600,000 for reasonable expenses
incurred by him relating to the stock purchase agreement.
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Except as set forth in the preceding sentence, all fees and
expenses incurred in connection with the Stock Purchase, the
stock purchase agreement and the transactions contemplated by
the stock purchase agreement will be paid by the party incurring
such fees or expenses.
Representations
and Warranties
The stock purchase agreement contains customary representations
and warranties of Mr. Utterberg on behalf of himself and
the MDS Entities relating to, among other things:
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title;
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noncontravention;
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appropriate approvals;
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residency;
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corporate organization, qualification and corporate power;
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capital structure;
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authorization, due execution and delivery of the stock purchase
agreement;
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subsidiaries;
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financial statements;
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absence of material changes;
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undisclosed liabilities;
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certain tax matters;
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ownership of assets and real property;
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certain matters relating to real property leases;
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intellectual property;
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inventory;
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the validity of material contracts to which the parties or their
subsidiaries are a party and the absence of any violation,
default or breach to such contracts;
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accounts receivable;
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powers of attorney;
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insurance;
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litigation matters;
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warranties;
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employees, employee benefits and related matters;
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environmental matters;
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compliance with certain laws;
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customers and suppliers;
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permits;
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certain business relationships with affiliates;
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the absence of brokerage or finders fees or agents
commissions;
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books and records;
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disclosure;
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controls and procedures;
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governmental contracts;
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questionable payments;
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privacy and related matters;
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customs; and
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the absence of any conflicts or violations of each partys
agreements as a result of the Stock Purchase or the stock
purchase agreement.
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The stock purchase agreement contains certain customary
representations and warranties of NxStage relating to, among
other things:
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corporate organization, qualification and corporate power;
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capital structure;
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authorization, due execution and delivery of the stock purchase
agreement;
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the absence of any conflicts or violations as a result of the
stock purchase agreement or the Stock Purchase;
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the absence of required consents, other than those specified;
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compliance with reporting obligations;
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financial statements; and
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absence of material changes.
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The representations and warranties are subject to materiality
and knowledge qualifiers in many respects. With certain
exceptions, the representations and warranties, will survive the
Stock Purchase closing for 24 months. Certain of the
representation and warranties will survive the closing beyond
24 months.
This description of the representations and warranties is
included to provide investors with information regarding the
terms of the stock purchase agreement. It is not intended to
provide any other factual information about us,
Mr. Utterberg or the MDS Entities. The assertions embodied
in the representations and warranties are subject to
qualifications and exceptions. Accordingly, you should not rely
on the representations and warranties as characterizations of
the actual state of facts at the time they were made or
otherwise.
The stock purchase agreement and consulting agreement,which are
described below, require Mr. Utterberg and us to indemnify
each other in the event of certain breaches and failures under
such agreements. Subject to certain limited exceptions, each
partys aggregate indemnification liability is limited to a
maximum amount equal to 50% of the value of the shares of our
common stock received in the Stock Purchase, measured as of the
consummation of the Stock Purchase, minus $1,250,000. The
agreements further provide that any amounts payable by either
party in connection with any such indemnification claim be paid
by delivery of additional shares of our common stock, valued at
the time of payment. However, we will not be required to issue
shares for indemnification purposes that in the aggregate would
exceed 20% of the then outstanding shares of our common stock
without stockholder approval. Any shares issued by us for
indemnification purposes will not be registered under the
Securities Act of 1933, as amended. Mr. Utterberg has
agreed to place 1,000,000 of the shares he will receive as
consideration for the Stock Purchase into escrow to secure his
indemnification obligations to us and to satisfy any purchase
price adjustments following the closing.
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LICENSE
AGREEMENT AND CONSULTING AGREEMENT
In connection with the Stock Purchase and as a result of MDS,
one of the MDS Entities, becoming a direct or indirect
wholly-owned subsidiary of ours, we will acquire rights under an
existing license agreement between MDS and DSU Medical
Corporation, a Nevada corporation, wholly-owned by
Mr. Utterberg, or DSU. Additionally, as a condition to the
parties obligations to consummate the Stock Purchase,
Mr. Utterberg and DSU will enter into a consulting
agreement with us. The license agreement and the consulting
agreement are detailed further below.
License
Agreement
Under the license agreement dated as of June 1, 2007 by and
between MDS and DSU, MDS received an exclusive, irrevocable,
sublicensable, royalty-free, fully paid license to certain DSU
patents, or the Licensed Patents, in exchange for a one-time
payment of $2,661,000. The Licensed Patents fall into two
categories, those patents that are used exclusively by the MDS
Entities, referred to as the Class A Patents, and those
patents that are used by the MDS Entities and other companies
owned by Mr. Utterberg, referred to as the Class B
Patents. Pursuant to the terms of the license agreement, MDS has
a license to (1) the Class A Patents, to practice in
all fields for any purpose and (2) the Class B
Patents, solely with respect to certain defined products for use
in the treatment of Extracorporeal Fluid Treatments
and/or Renal
Insufficiency Treatments. The license agreement further provides
that MDS rights under the agreement are qualified by
certain sublicenses previously granted to third parties. We have
agreed that Mr. Utterberg will retain the right to the
royalty income under one of these sublicenses.
Consulting
Agreement
Under this consulting agreement, Mr. Utterberg and DSU will
provide consulting, advisory and related services to us for a
period of two years following the consummation of the Stock
Purchase. In addition, under the terms of the consulting
agreement, Mr. Utterberg and DSU will agree during the term
of the agreement not to compete with us in the field defined in
the consulting agreement and not to encourage or solicit any
employees, customers or suppliers of ours to alter its
relationship with us. The consulting agreement will further
provide that (1) Mr. Utterberg and DSU will assign to
us certain inventions and proprietary rights received by him/it
during the term of the agreement and (2) we will grant
Mr. Utterberg and DSU an exclusive, worldwide, perpetual,
royalty-free irrevocable, sublicensable, fully paid license
under such assigned inventions and proprietary rights for any
purpose outside the inventing field, as defined in the
consulting agreement. Under the terms of the consulting
agreement, Mr. Utterberg and DSU will receive an aggregate
of $200,000 per year, plus expenses, in full consideration for
the services and other obligations provided for under the terms
of the consulting agreement. The consulting agreement also
requires us and Mr. Utterberg to indemnify each other in
the event of certain breaches and failures under the agreement
and requires that any such indemnification liability be
satisfied with shares of our common stock, valued at the time of
payment.
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In March 2006, we received clearance from the FDA to market our
PureFlow SL module as an alternative to the bagged fluid
presently used with our System One in the chronic care market,
and we commercially launched the PureFlow SL module in July
2006. This accessory to the System One allows for the
preparation of high purity dialysate in the patients home
using ordinary tap water and dialysate concentrate.
We closed a follow-on public offering of our common stock on
June 14, 2006, which resulted in the issuance of
6,325,000 shares of common stock at $8.75 per share.
We received net proceeds from the offering of approximately
$51.3 million.
At December 31, 2006, 1,022 ESRD patients were using the
System One at 174 dialysis clinics, compared to 292 ESRD
patients at 70 dialysis clinics at December 31, 2005. In
addition, at December 31, 2006, 77 hospitals were using the
System One for critical care therapy, compared to 50 hospitals
at December 31, 2005.
Medisystems. In January 2007, we entered into
a seven-year agreement with Medisystems Corporation pursuant to
which Medisystems will supply to us no less than 90% of our
North American requirements for disposable cartridges for use
with the System One. The agreement may be terminated upon a
material breach, generally following a
120-day cure
period. Medisystems is a related party to NxStage. David
Utterberg, the president and sole stockholder of Medisystems, is
a director and significant stockholder of the Company.
On June 4, 2007 we entered into a stock purchase agreement
with Mr. Utterberg, who is a member of our board of
directors and owns 6.7% of our outstanding common stock,
pursuant to which we will acquire all of the outstanding equity
of each MDS Entity and each MDS Entity will become a direct or
indirect wholly-owned subsidiary of ours. Mr. Utterberg
will receive 6,500,000 shares of our common stock, subject
to a post-closing working capital adjustment as consideration
for the Stock Purchase.
Membrana. In January 2007, we entered into a
long-term supply agreement with Membrana pursuant to which
Membrana has agreed to supply, on an exclusive basis, capillary
membranes for use in the filters used with the System One for
ten years. In exchange for Membranas agreement to pricing
reductions based on volumes ordered, we have agreed to purchase
a base amount of membranes per year. The agreement may be
terminated upon a material breach, generally following a
60-day cure
period.
DaVita. On February 7, 2007, we entered
into a National Service Provider Agreement with DaVita, our
largest customer. Pursuant to the terms of the agreement, we
granted to DaVita certain market rights for the System One and
related supplies for home hemodialysis therapy. We granted
DaVita exclusive rights in a small percentage of geographies,
which geographies collectively represent less than 10% of the
U.S. ESRD patient population, and limited exclusivity in
the majority of all other U.S. geographies, subject to
DaVitas meeting certain requirements, including patient
volume commitments and new patient training rates. Under the
agreement, we can continue to sell to other clinics in the
majority of geographies. If certain minimum patient numbers or
training rates are not achieved, DaVita can lose all or part of
its preferred geographic rights. Under the agreement, DaVita
commits to purchase all of its existing System One equipment
currently being rented from us (for a purchase price of
approximately $5.0 million) and to buy a significant
percentage of its future System One equipment needs.
The agreement has an initial term of three years, terminating on
December 31, 2009, and DaVita has the option of renewing
the agreement for four additional periods of six months if
DaVita meets certain patient volume targets.
In connection with the National Service Provider Agreement, on
February 7, 2007, DaVita purchased 2,000,000 shares of our
common stock for a purchase price of $10.00 per share.
Entrada. During the six months ended
June 30, 2007, we entered into a long-term agreement with
the Entrada Group, or Entrada, to establish manufacturing and
service operations in Mexico, initially for our cycler and
PureFlow SL disposables and later for our PureFlow SL hardware.
The agreement obligates Entrada
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to provide us with manufacturing space, support services and a
labor force through 2012. The agreement may be terminated upon
material breach, generally following a 30-day cure period.
Product Reliability Issue. In the second
quarter of 2007, we started to experience an increased incidence
of reported dialysate leaks associated with our System One
cartridges. The reported incidence of leaks is higher than we
have historically observed. When the System One is used in
accordance with its instructions, these leaks present no risk to
patient health. System One device labeling anticipates the
potential for leaks to occur and specifically warns against
leaks and alerts users of the need to observe treatments in
order to detect leaks. Four patients with reported leaks, that
were unobserved by these patients or their partners until after
their treatments were terminated, reported hypotension, or low
blood pressure, resolved by a fluid bolus, with no lasting
clinical effect. In early August 2007, we sent a letter to our
patients and customers informing them of the increased incidence
in leaks and reminding them of existing System One labeling
alerting users of the potential for leaks and instructing them
to observe treatments in order to detect any leaks. We have
characterized this notification as a voluntary recall. On
August 24, 2007, we elected to initiate a second step in
our recall actions, and decided to physically recall the
affected lots of cartridge inventory being held by chronic
market customers and patients, and replace the affected
inventory with newer lots of cartridges at no charge. We have
instructed patients and customers to destroy all inventory of
affected cartridges they have on hand, and we expect to
write-off up to all of the inventory of affected cartridges we
have in-house. It is possible that we may be able to rework this
cartridge inventory, or reuse certain components of this
inventory, but we have not made a final determination related to
this recovery.
Based on these facts, we determined on August 24, 2007 that
we would incur total charges in connection with this recall in
the range of $1.9 million to $2.5 million, the
principal component of which relates to the write-off of
inventory in the range of $1.8 million to
$2.2 million. Other charges primarily relate to increased
shipping for replacement product and cycler servicing costs.
Substantially all of these charges would be recorded in the
quarter ending September 30, 2007.
The increased incidence in leaks has also been associated with
increased cycler service requirements, which have led to
increased service costs as well as imposed additional service
pool requirements on our cycler inventory. In the short term,
this may impede our ability to meet customer demand.
Resignation of Chief Operating Officer. On
August 28, 2007, Philip R. Licari, our Senior Vice
President and Chief Operating Officer, announced his intention
to resign from NxStage effective upon the completion of the
Stock Purchase.
We are a medical device company that develops, manufactures and
markets innovative systems for the treatment of ESRD and acute
kidney failure. Our primary product, the System One, is a small,
portable,
easy-to-use
hemodialysis system designed to provide physicians and patients
improved flexibility in how hemodialysis therapy is prescribed
and delivered. Given its design, the System One is particularly
well-suited for home hemodialysis and more frequent, or
daily, dialysis, which clinical literature suggests
provides patients better clinical outcomes and improved quality
of life. The System One is specifically cleared by the FDA
for home hemodialysis as well as hospital and clinic-based
dialysis. We believe the largest market opportunity for our
product is the home hemodialysis market for the treatment of
ESRD.
ESRD, which affects approximately 472,000 people in the
United States, is an irreversible, life-threatening loss of
kidney function that is treated predominantly with dialysis.
Dialysis is a kidney replacement therapy that removes toxins and
excess fluids from the bloodstream and, unless the patient
receives a kidney transplant, is required for the remainder of
the patients life. Over 70% of ESRD patients in the United
States rely on life-sustaining dialysis treatment. Hemodialysis,
the most widely prescribed type of dialysis, typically consists
of treatments in a dialysis clinic three times per week, with
each session lasting three to five hours. Approximately 8% of
U.S. ESRD dialysis patients receive some form of dialysis
treatment at home, most of whom treat themselves with peritoneal
dialysis, or PD, although surveys of physicians and healthcare
professionals suggest that a larger proportion of patients could
take responsibility for their own care. We
77
believe there is an unmet need for a hemodialysis system that
allows more frequent and easily administered therapy at home and
have designed our system to address this and other kidney
replacement markets.
Measuring 15x15x18 inches, the System One is the smallest,
commercially available hemodialysis system. It consists of a
compact, portable and
easy-to-use
cycler, disposable drop-in cartridge and high purity premixed
fluid. The System One has a self-contained design and simple
user interface making it easy to operate by a trained patient
and his or her trained partner in any setting prescribed by the
patients physician. Unlike traditional dialysis systems,
our System One does not require any special disinfection and its
operation does not require specialized electrical or plumbing
infrastructure or modifications to the home. Patients can bring
the System One home, plug it in to a conventional electrical
outlet and operate it, thereby eliminating what can be expensive
plumbing and electrical household modifications required by
other traditional dialysis systems. Given its compact size and
lack of infrastructure requirements, the System One is portable,
allowing patients freedom to travel. We believe these features
provide patients and their physicians new treatment options for
ESRD.
We market the System One to dialysis clinics for chronic
hemodialysis treatment, providing clinics with improved access
to a developing market, the home hemodialysis market, and the
ability to expand their patient base by adding home-based
patients without adding clinic infrastructure. The clinics in
turn provide the System One to ESRD patients. For each month
that a patient is treated with the System One, we bill the
clinic for the purchase of the related disposable cartridges and
treatment fluids necessary to perform treatment. Typically, our
customers have rented the System One equipment on a month to
month basis, although early in 2007, two of our dialysis chain
customers have elected to purchase rather than rent System One
equipment. Clinics receive reimbursement from Medicare, private
insurance and patients for dialysis treatments. We commenced
marketing the System One for chronic hemodialysis treatment in
September 2004. As of June 30, 2007, 1,615 ESRD
patients were using the System One at 200 different dialysis
clinics. Substantially all of these patients are treated at home
or are in training to treat themselves at home; the remaining
patients are doing therapy in a clinic.
We are not responsible for, and do not provide, patient
training. Training is provided by the patients dialysis
clinic and takes place at the clinic primarily during the
patients prescribed, often daily, two to three hour
treatment sessions. Patient training, which typically takes two
to three weeks, includes basic instruction on ESRD, operation of
the System One and insertion by the patient or their partner of
needles into the patients vascular access site. Clinics
provide testing to patients and their partners at the conclusion
of training to verify skills and an understanding of System One
operation. Training sessions are reimbursed by Medicare, and
there may be a co-payment requirement to the patient associated
with this training.
Medicare reimburses the same amount per treatment for home and
in-center hemodialysis treatments, up to three treatments per
week. Payment for more than three treatments per week is
available with appropriate medical justification. The adoption
of our System One for more frequent therapy for ESRD could be
slowed if Medicare is reluctant or refuses to pay for these
additional treatments.
We also market the System One in the critical care market to
hospitals for treatment of acute kidney failure and fluid
overload. It is estimated that there are over 200,000 cases of
acute kidney failure in the United States each year. The System
One provides an effective,
simple-to-operate
alternative to dialysis systems currently used in the hospital
to treat these acute conditions. We commenced marketing the
System One to the critical care market in February 2003. As of
June 30, 2007, 93 hospitals were using the System One to
deliver acute kidney failure and fluid overload therapy.
We were incorporated in Delaware in 1998 under the name QB
Medical, Inc., and later changed our name to NxStage Medical,
Inc. Our principal executive offices are located at 439 South
Union Street, Fifth Floor, Lawrence, Massachusetts 01843.
78
Our
Products and Services
The
System One
Our primary product, the System One, is a small, portable,
easy-to-use
hemodialysis system, which incorporates multiple design
technologies and design features.
The System One includes the following components:
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The NxStage Cycler. A compact portable
electromechanical device containing pumps, control mechanisms,
safety sensors and remote data capture functionality.
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The NxStage Cartridge. A single-use,
disposable, integrated treatment cartridge that loads simply and
easily into the cycler. The cartridge incorporates a proprietary
volumetric fluid management system and includes a pre-attached
dialyzer.
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Premixed Dialysate. The System One uses
high-purity premixed dialysate for hemodialysis applications.
The volume of fluids used varies with treatment options and
prescription, but typical weekly volumes are similar to the
amount of dialysate used by a patient on PD. We supply our
premixed dialysate in sterile five liter bags or through the use
of our PureFlow SL module, which received FDA clearance in March
2006 and was made available to our customers beginning in July
2006. The PureFlow SL module allows for the preparation of
dialysate fluid in the patients home using ordinary tap
water and dialysate concentrate thereby eliminating the need for
bagged fluids.
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For the ESRD market, the System One is designed to make home
treatment and more frequent treatment easier and more practical.
Although most are not performed using our product, clinical
studies suggest that therapy administered five to six times per
week, commonly referred to as daily therapy, better mimics the
natural functioning of the human kidney and can lead to improved
clinical outcomes, including reduction in hypertension, improved
anemia status, reduced reliance on pharmaceuticals, improved
nutritional status, reduced hospitalizations and overall
improvement in quality of life. Other published literature also
supports the clinical and quality of life benefits associated
with home dialysis therapy.
For the critical care market, our System One is designed to
offer clinicians an alternative that simplifies the delivery of
acute kidney replacement therapy and makes longer or continuous
critical care therapies easier to deliver. The ability of our
system to perform hemofiltration
and/or
isolated ultrafiltration, for which the System One is also FDA
cleared, is advantageous, as many clinicians choose to prescribe
this therapy for patients with acute kidney failure.
Chronic
Care
The dialysis therapy market is mature, consolidated and
competitive. We compete with suppliers of hemodialysis and
peritoneal dialysis devices and certain dialysis device
manufacturers that also provide dialysis services. We currently
face direct competition in the United States primarily from
Fresenius Medical Care AG, or Fresenius, Baxter Healthcare, or
Baxter, Gambro AB or Gambro, B. Braun or B. Braun, and
others. Fresenius, Baxter and Gambro each have large and
well-established dialysis products businesses.
We believe the competition in the market for kidney dialysis
equipment and supplies is based primarily on:
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product quality;
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ease-of-use;
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cost effectiveness;
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sales force coverage; and
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clinical flexibility.
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We believe that we compete favorably in terms of product quality
and ease of use due to our System One design, portability,
drop-in cartridge and use of premixed fluids. We believe we also
compete favorably on the basis of clinical flexibility, given
the System Ones ability to work well in acute and chronic
settings and to perform hemofiltration, hemodialysis and
ultrafiltration. We believe we compete favorably in terms of
cost-effectiveness to clinics. Although our product is priced at
a premium compared to some competitive products in the market,
we allow clinics to reduce labor costs by offering their
patients a home treatment alternative. We compete unfavorably in
terms of sales force coverage and branding because we have only
recently commenced commercial sales of our System One in the
chronic care market and have a smaller sales force than most of
our competitors.
Our primary competitors are large, well-established businesses
with significantly more financial and personnel resources than
us. They also have significantly greater commercial
infrastructures than we have. We believe our ability to compete
successfully will depend largely on our ability to:
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establish the infrastructures necessary to support a growing
home and critical care dialysis products business;
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maintain and improve product quality;
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continue to develop sales and marketing capabilities;
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achieve cost reductions; and
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access the capital needed to support the business.
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Our ability to successfully market the System One, and any
products we may develop in the future, for the treatment of
kidney failure could also be adversely affected by
pharmacological and technological advances in preventing the
progression of chronic ESRD
and/or in
the treatment of acute kidney failure, technological
developments by others in the area of dialysis, the development
of new medications designed to reduce the incidence of kidney
transplant rejection and progress in using kidneys harvested
from genetically-engineered animals as a source of transplants.
There can be no assurance that competitive pressure or
pharmacological or technological advancements will not have a
material adverse effect on our business.
Critical
Care
We believe that competition in the critical care market will be
affected by system functionality,
ease-of-use,
reliability, portability and infrastructure requirements. In the
fluid overload market, we believe competition will be further
affected by physicians willingness to adopt
ultrafiltration as a viable treatment alternative to
pharmaceutical therapy. In the critical care market, we face
direct competition from Gambro, Baxter, B. Braun and Fresenius.
In the fluid overload market, drug therapy is currently the most
common and preferred treatment. To date, ultrafiltration has not
been broadly adopted and, if the medical community does not
accept ultrafiltration as clinically useful, cost-effective and
safe, we will not be able to successfully compete against
existing pharmaceutical therapies. Our ability to successfully
market the System One for the treatment of fluid overload
associated with multiple diseases, including congestive heart
failure, or CHF, could also be adversely affected by
pharmacological and technological advances in preventing or
treating fluid overload.
We sell our products in two markets: the chronic care market and
the critical care market. We have separate marketing and sales
efforts dedicated to each market. In 2006, sales to DaVita, Inc.
represented 19.4% of our total revenues, and DaVita is expected
to remain a significant customer of ours in 2007. No other
single customer represented 10% or more of our revenues in 2006.
In 2005, sales to Clarian Health Partners represented 10.0% of
our total revenues, sales to Renal Care Group represented 12.4%
of our total revenues and sales to Wellbound, Inc. represented
10.5% of our total revenues. No other single customer
represented 10% or more of our revenues in 2005.
80
Chronic
Care
In the chronic care market, our customers are independent
dialysis clinics as well as dialysis clinics that are part of
national chains. Since Medicare regulations require that all
chronic ESRD patients be under the care of a dialysis clinic,
whether they are treated at-home, in-clinic or with a kidney
transplant, we do not, and cannot, sell the System One directly
to chronic care patients.
We have a chronic care direct sales force that calls on dialysis
clinics. In addition to specialized sales representatives, we
also employ nurses on our chronic care sales force to serve as
clinical educators to support our sales efforts.
Currently, there are approximately 4,500 Medicare-certified
dialysis outpatient facilities in the United States. Ownership
of these clinics is highly consolidated with DaVita controlling
approximately 27% and Fresenius controlling approximately 33%
after giving effect to Fresenius acquisition of Renal Care
Group. Smaller chains and independent clinics and hospitals
represent the approximately 40% of remaining clinics. Our
customers include independent clinics as well as large and
smaller chains.
In February 2007, we entered into an agreement with DaVita that
grants DaVita certain market rights for the System One and
related supplies for home hemodialysis therapy. Under this
agreement, we granted DaVita exclusive rights in a small
percentage of geographies, which geographies collectively
represent less than 10% of the U.S. ESRD patient
population, and limited exclusivity in the majority of all other
U.S. geographies, subject to DaVitas meeting certain
requirements, including patient volume commitments and new
patient training rates. We will continue to sell to other
clinics in the majority of geographies. The agreement limits,
but does not prohibit, the sale by NxStage of the System One for
chronic home hemodialysis therapy to any provider that is under
common control or management of a parent entity that
collectively provides dialysis services to more than 25% of
U.S. chronic dialysis patients and that also supplies
dialysis products. NxStage is, therefore, limited to some extent
in its ability to sell the System One for chronic home
hemodialysis therapy to Fresenius.
After renting or selling a System One to a clinic, our sales
representatives and clinical educators train the clinics
nurses and dialysis technicians on the proper use of the system
using proprietary training materials. We then rely on the
trained technicians and nurses to train home patients and other
technicians and nurses using the System One, rather than sending
our sales representatives and nurses back to the clinic to train
each new patient, nurse or technician. This approach also allows
the clinic and physician to select, train and support the
dialysis patients that will use our system, much the same way as
they manage their patients who are on PD therapy.
We began marketing the System One to perform hemodialysis for
ESRD patients in September 2004. As of June 30, 2007, there
were 1,615 patients with chronic ESRD using the System One.
Critical
Care
In the critical care market, because both acute kidney failure
and fluid overload are typically treated in hospital intensive
care units, our customers are hospitals. We are specifically
focusing our sales efforts in the critical care market on those
large institutions that we believe are most dedicated to
increased and improved dialysis therapy for patients with acute
kidney failure and believe in ultrafiltration as an
earlier-stage treatment option for fluid overload associated
with multiple diseases, including CHF.
We have a critical care direct sales force that calls on
hospitals. In addition to specialized sales representatives, we
also employ nurses in our critical care sales force to serve as
clinical educators to support our sales efforts.
The System One for the critical care market has a list price of
$28,000; this price does not include the related disposables
required for each treatment. After selling or placing a System
One in a hospital, our sales representatives and clinical
educators train the hospitals intensive care unit, or ICU,
and acute dialysis nurses on the proper use of the system using
proprietary training materials. We then rely on the trained
nurses to
81
train other nurses. By adopting this train the
trainer approach, our sales representatives and nurses do
not need to return to the hospital each time a new nurse needs
to be trained.
We began promoting our System One product for use in the
critical care market in February 2003. As of June 30, 2007,
we had 93 hospitals as critical care customers.
Customer
Support Services
We primarily use a depot service model for equipment servicing
and repair for the chronic care market. If a device malfunctions
and requires repair, we arrange for a replacement device to be
shipped to the site of care, whether it is a patients
home, clinic or hospital, and for pick up and return to us of
the system requiring service. This shipment is done by common
carrier, and, as there are no special installation requirements,
the patient, clinic or hospital can quickly and easily set up
the new machine. In addition, we ship monthly supplies via
common carrier and courier services directly to chronic care
patients, dialysis clinics and hospitals.
In addition to depot service, the critical care market also
demands field service calls for cycler servicing and repair. The
nature of the hospital environment, coupled with the practices
of other ICU dialysis equipment suppliers, frequently
necessitates
on-site
clinical support for our systems installed in this environment.
We maintain telephone service
coverage 24-hours
a day, seven days a week, to respond to technical questions
raised by patients, clinics and hospitals concerning our System
One product.
Our research and development organization has focused on
developing innovative technical approaches that address the
limitations of current dialysis systems. Our development team
has skills across the range of technologies required to develop
and maintain dialysis systems. These areas include filters,
tubing sets, mechanical systems, fluids, software and
electronics. In response to physician and patient feedback and
our own assessments, we are continually working on enhancements
to our product designs to improve
ease-of-use,
functionality, reliability and safety. We also seek to develop
new products that supplement positively our existing product
offerings and intend to continue to actively pursue
opportunities for the research and development of complementary
products.
For the years ended December 31, 2006, 2005 and 2004, we
incurred research and development expenses of $6.4 million,
$6.3 million and $6.0 million, respectively.
We seek to protect our investment in the research, development,
manufacturing and marketing of our products through the use of
patent, trademark, copyright and trade secret law. We own or
have rights to a number of patents, trademark, copyrights, trade
secrets and other intellectual property directly related and
important to our business.
82
As of December 31, 2006, we had 25 issued U.S. and
international patents and 49 U.S., international and foreign
pending patent applications.
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Patent No.
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Regime
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Filed
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Expiration Date
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Description
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6,254,567
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U.S.
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2/23/2000
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2/26/2019
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Addresses fluids requirement by
regenerating dialysate
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6,554,789
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U.S.
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2/25/2000
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2/14/2017
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Panels defined by seals and
overlying panels
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6,572,576
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U.S.
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7/7/2001
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7/2/2021
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Leak detection by flow reversal
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6,572,641
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U.S.
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4/9/2001
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4/9/2021
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Fluid warmer that removes air
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6,579,253
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U.S.
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2/25/2000
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2/14/2017
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Balancing chambers are defined by
panels of the circuit
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6,582,385
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U.S.
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2/19/1998
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2/19/2018
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Addresses fluids requirement by
purifying waste
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6,589,482
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U.S.
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2/25/2000
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2/14/2017
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Panels form a combination to
mutually displace waste and replacement fluid
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6,595,943
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U.S.
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2/25/2000
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2/14/2017
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Blood pressure control in filter
to optimize throughput
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6,638,477
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U.S.
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2/25/2000
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2/14/2017
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Divert part of waste stream to
control ultrafiltration or rinse
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6,638,478
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U.S.
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2/25/2000
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2/14/2017
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Mechanically coupled flow
assemblies that balance flow of incoming and outgoing fluid
streams, respectively
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6,649,063
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U.S.
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7/12/2001
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10/7/2021
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Using the filter to generate
sterile replacement fluid
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6,673,314
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U.S.
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2/25/2000
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2/14/2017
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Supply notification including
third-party notification by network
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6,702,561
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U.S.
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7/12/2001
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9/8/2021
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Potting distribution channel
molded into filter housing
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6,743,193
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U.S.
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7/17/2001
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7/17/2021
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Hermetic valve design
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6,830,553
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U.S.
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2/25/2000
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2/14/2017
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Sterile filter in replacement
fluid line
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6,852,090
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U.S.
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5/24/2001
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12/10/2017
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Balancing chambers are defined by
circuit portions defined in cooperation with the base
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6,872,346
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U.S.
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3/20/2003
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5/14/2023
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Manufacturing method for filters
using radiant heat to seal filter fibers
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6,955,655
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U.S.
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6/27/2001
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10/7/2017
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Frequent treatment with simple
setup
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6,979,309
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U.S.
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1/7/2002
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6/19/2017
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New frequent hemofiltration
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7,004,924
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U.S.
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10/19/1998
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2/11/2018
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Methods, systems, and kits for the
extracorporeal processing of blood
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7,040,142
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U.S.
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1/4/2002
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2/9/2022
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Method and apparatus for leak
detection in blood circuits combining external fluid detection
and air infiltration detection
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7,087,033
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U.S.
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7/8/2002
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8/22/2021
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Method and apparatus for leak
detection in a fluid line
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7,112,273
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U.S.
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9/26/2003
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10/4/2023
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Volumetric fluid balance control
for extracorporeal blood treatment
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7,147,613
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U.S.
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3/8/2004
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8/29/2020
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Measurement of fluid pressure in a
blood treatment device
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EP969887
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EP (UK)
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2/5/1998
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2/14/2017
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Frequent treatment with simple
setup
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Patents for individual products extend for varying periods of
time according to the date a patent application is filed or a
patent is granted and the term of the patent protection
available in the jurisdiction granting the patent. The scope of
protection provided by a patent can vary significantly from
country to country.
83
In addition to our patents and pending patent applications in
the United States and selected
non-U.S. markets,
we possess trade secrets and proprietary know-how relating to
our products. Any of our trade secrets, know-how or other
technology not protected by a patent could be misappropriated,
or independently developed by, a competitor and could, if
independently invented and patented by a competitor, under some
circumstances, be used to prevent us from further use of such
secrets.
Our strategy is to develop patent portfolios for our research
and development projects. We monitor the activities of our
competitors and other third parties with respect to their use of
intellectual property. We intend to aggressively defend the
patents we hold, and we intend to vigorously contest claims
other patent holders may bring against us.
The medical device industry is characterized by the existence of
a large number of patents and frequent litigation based on
allegations of patent infringement. While we attempt to ensure
that our products and methods do not infringe other
parties patents and proprietary rights, our competitors
may assert that our products, or the methods that we employ, are
covered by patents held by them. In addition, our competitors
may assert that future products and methods we may market
infringe their patents.
We require our employees, consultants and advisors to execute
confidentiality agreements in connection with their employment,
consulting or advisory relationship with us. We also require our
employees to agree to disclose and assign to us all inventions
conceived by them during their employment with us. Similar
obligations are imposed upon consultants and advisors performing
work for us relating to the design or manufacture of our
products. Despite efforts taken to protect our intellectual
property, unauthorized parties may attempt to copy aspects of
our products or to obtain and use information that we regard as
proprietary.
The manufacture of our products is accomplished through a
complementary combination of outsourcing and internal
production. Specifically, we assemble, package and label our
PureFlow SL disposables within our 45,000 square foot
facility in Lawrence, Massachusetts and 24,000 square foot
facility in North Andover, Massachusetts. We recently commenced
manufacture of PureFlow SL disposables in Fresnillo, Mexico. We
also manufacture our dialyzers internally, within our
5,000 square foot facility in Rosdorf, Germany. We
outsource the manufacture of our disposable cartridges, premixed
dialysate and the System One cycler, although we have just
initiated internal manufacture of the cycler as well in
Fresnillo, Mexico.
We have single-source suppliers of components, but in most
instances there are alternative sources of supply available.
Where obtaining a second source is more difficult, we have tried
to establish supply agreements that better protect our
continuity of supply. These agreements, currently in place with
several key suppliers, are intended to establish commitments to
supply product. We do not have supply agreements in place with
all of our single-source suppliers.
We have certain agreements that grant certain suppliers
exclusive or semi-exclusive supply rights. In January 2007, we
entered into a long-term supply agreement with Membrana GmbH
pursuant to which Membrana has agreed to supply, on an exclusive
basis, capillary membranes for use in the filters used with the
System One for ten years. In exchange for Membranas
agreement to pricing reductions based on volumes ordered, we
have agreed to purchase a base amount of membranes per year. The
agreement may be terminated upon a material breach, generally
following a 60-day cure period.
In January 2007 we also entered into a seven-year agreement with
MDS pursuant to which MDS will supply to us no less than 90% of
our North American requirements for disposable cartridges for
use with the System One. The agreement may be terminated upon a
material breach, generally following a 120-day cure period. MDS
is a related party to NxStage. David Utterberg, the president
and sole stockholder of MDS, is a director and significant
stockholder of NxStage. In accordance with our Audit Committee
Charter, the MDS supply agreement was approved by our audit
committee as well as our board of directors.
KMC Systems, Inc. manufactures the System One cycler for us
pursuant to an agreement that obligates KMC to continue to
provide product to us at least through mid-2008. This agreement
also allows us the option
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to manufacture for ourself an increasing portion of cyclers as
we deem appropriate over the remaining term. The contract may be
terminated upon a material breach, generally following a
30-day cure
period.
We purchase bicarbonate-based premixed dialysate from B. Braun
and our lactate-based premixed dialysate from Laboratorios PISA.
We have a long-term supply agreement with B. Braun that
obligates B. Braun to supply the dialysate to us through 2009 in
exchange for modest minimum purchase requirements of
approximately $100,000 per year. The contract may be terminated
upon a material breach, generally following a
30-day cure
period. We have entered into a supply agreement with PISA that
obligates PISA to supply dialysate to us through 2008 in
exchange for annual purchase commitments of approximately
$1.0 million. The contract may be terminated upon a
material breach, generally following a
30-day cure
period.
We are currently purchasing our PureFlow SL module and chassis
from Enercon. We are operating under a short-term supply
agreement with Enercon that obligates Enercon to supply this
equipment to us through July 2007. There are no minimums or
exclusivity clauses associated with this agreement, and the
agreement renews on a year-to-year basis, unless prior written
notice is given by either party. The contract may be terminated
upon a material breach, generally following a
30-day cure
period.
Food
and Drug Administration
In the United States, our products are subject to regulation by
the FDA, which regulates our products as medical devices. The
FDA regulates the clinical testing, manufacture, labeling,
distribution, import and export, sale and promotion of medical
devices. Noncompliance with applicable FDA requirements can
result in, among other things, fines, injunctions, civil
penalties, recall or seizure of products, total or partial
suspension of production, failure of the government to grant
pre-market clearance or pre-market approval for devices,
withdrawal of marketing clearances or approvals and criminal
prosecution.
Unless an exemption applies, all medical devices must receive
either prior 510(k) clearance or pre-market approval from the
FDA before they may be commercially distributed in the United
States. Submissions to obtain 510(k) clearance and pre-market
approval must be accompanied by a user fee, unless exempt. In
addition, the FDA can also impose restrictions on the sale,
distribution or use of devices at the time of their clearance or
approval, or subsequent to marketing.
The FDA classifies medical devices into one of three classes:
Class I, Class II or Class III
depending on the FDAs assessment of the degree of risk
associated with the device and the controls it deems necessary
to reasonably ensure the devices safety and effectiveness.
The FDA has deemed our System One to be a Class II medical
device and we have marketed it as such in the United States.
Class I devices are those for which safety and
effectiveness can be assured by adherence to a set of general
controls, which include compliance with facility registration
and product listing requirements, reporting of adverse events,
and appropriate, truthful and non-misleading labeling,
advertising and promotional materials. Class II devices are
also subject to these same general controls, as well as any
other special controls deemed necessary by the FDA to ensure the
safety and effectiveness of the device. These special controls
can include performance standards, post-market surveillance,
patient registries and FDA guidelines. Pre-market review and
clearance by the FDA for Class II devices is accomplished
through the 510(k) pre-market notification procedure, unless the
device is exempt. When 510(k) clearance is required, a
manufacturer must submit a pre-market notification to the FDA
demonstrating that the proposed device is substantially
equivalent in intended use and in safety and effectiveness to a
legally marketed device that is not subject to pre-market
approval, i.e., a device that was legally marketed prior to
May 28, 1976 and for which the FDA has not yet required
pre-market approval; a device which has been reclassified from
Class III to Class II or I; or a novel device
classified into Class I or II through de novo
classification. If the FDA agrees that the device is
substantially equivalent to the predicate, it will subject the
device to the same classification and degree of regulation as
the predicate device, thus effectively granting clearance to
market it. After a device receives 510(k) clearance, any
modification that could significantly affect its safety or
effectiveness, or that would constitute a major change in its
intended use, requires a new 510(k) clearance or possibly a
pre-market approval. Class III devices are
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devices for which insufficient information exists that general
or special controls will provide reasonable assurance of safety
and effectiveness, and the devices are life-sustaining,
life-supporting, or implantable, or of substantial importance in
preventing the impairment of human health, or present a
potential, unreasonable risk of illness or injury.
Class III devices requiring an approved pre-market approval
application to be marketed are devices that were regulated as
new drugs prior to May 28, 1976, devices not found
substantially equivalent to devices marketed prior to
May 28, 1976 and Class III
pre-amendment
devices, which are devices introduced in the U.S. market
prior to May 28, 1976, that by regulation require
pre-market approval.
FDA
Regulatory Clearance Status
We currently have all of the regulatory clearances required to
market the System One in the United States in both the chronic
and critical care markets. The FDA has cleared the System One
for the treatment, under a physicians prescription, of
renal failure or fluid overload using hemofiltration,
hemodialysis
and/or
ultrafiltration. The FDA has also specifically cleared the
System One for home hemodialysis use under a physicians
prescription.
We received our first clearance from the FDA for a predecessor
model to the System One in January 2001 for hemofiltration and
ultrafiltration. In July 2003, we received expanded clearance
from the FDA for the System One for hemodialysis, hemofiltration
and ultrafiltration. Most recently, in June 2005, we received
FDA clearance specifically allowing us to promote home
hemodialysis using the System One. We have received a total of
20 product clearances from the FDA since our inception in
December 1998. We continue to seek opportunities for product
improvements and feature enhancements, which will, from time to
time, require FDA clearance before market launch.
FDA
Clearance Procedures
510(k) Clearance Pathway. When we are required
to obtain a 510(k) clearance for a device, which we wish to
market, we must submit a pre-market notification to the FDA
demonstrating that the device is substantially equivalent to a
device that was legally marketed prior to May 28, 1976 and
for which the FDA has not yet required pre-market approval; a
device which has been reclassified from Class III to
Class II or I; or a novel device classified into
Class I or II through de novo classification. The FDA
attempts to respond to a 510(k) pre-market notification within
90 days of submission of the notification (or in some
instances 30 days under what is referred to as
special 510(k) submission), but the response may be
a request for additional information or data, sometimes
including clinical data. As a practical matter, pre-market
clearance can take significantly longer, including up to one
year or more.
After a device receives 510(k) clearance for a specific intended
use, any modification that could significantly affect its safety
or effectiveness, or that constitutes a major change in its
intended use, would require a new 510(k) clearance or could
require pre-market approval. In the first instance, the
manufacturer may determine that a change does not require a new
510(k) clearance. The FDA can review any such decision and can
disagree with a manufacturers determination. If the FDA
disagrees with a manufacturers determination that a new
clearance or approval is not required for a particular
modification, the FDA can require the manufacturer to cease
marketing
and/or
recall the modified device until 510(k) clearance or pre-market
approval is obtained.
Pre-market Approval Pathway. A pre-market
approval application must be submitted if the device cannot be
cleared through the 510(k) process. The pre-market approval
process is much more demanding than the 510(k) pre-market
notification process. A pre-market approval application must be
supported by extensive data and information including, but not
limited to, technical, preclinical, clinical trials,
manufacturing and labeling to demonstrate to the FDAs
satisfaction the safety and effectiveness of the device.
After the FDA determines that a pre-market approval application
is complete, the FDA accepts the application and begins an
in-depth review of the submitted information. The FDA, by
statute and regulation, has 180 days to review an accepted
pre-market approval application, although the review generally
occurs over a significantly longer period of time, and can take
up to several years. During this review period, the FDA may
request additional information or clarification of information
already provided. Also during the review
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period, an advisory panel of experts from outside the FDA may be
convened to review and evaluate the application and provide
recommendations to the FDA as to the approvability of the
device. In addition, the FDA will conduct a pre-approval
inspection of the manufacturing facility to ensure compliance
with the Quality System Regulations. New pre-market approval
applications or supplemental pre-market approval applications
are required for significant modifications to the manufacturing
process, labeling, use and design of a device that is approved
through the pre-market approval process. Pre-market approval
supplements often require submission of the same type of
information as a pre-market approval application, except that
the supplement is limited to information needed to support any
changes from the device covered by the original pre-market
approval application, and may not require as extensive clinical
data or the convening of an advisory panel.
Clinical Trials. A clinical trial is almost
always required to support a pre-market approval application and
is sometimes required for a 510(k) pre-market notification.
Clinical trials for devices that involve significant risk,
referred to as significant risk devices, require submission of
an application for an investigational device exemption, or IDE,
to the FDA. The IDE application must be supported by appropriate
data, such as animal and laboratory testing results, showing
that it is safe to test the device in humans and that the
testing protocol is scientifically sound. Clinical trials for a
significant risk device may begin once the IDE application is
approved by the FDA and the institutional review board, or IRB,
overseeing the clinical trial. If FDA fails to respond to an IDE
application within 30 days of receipt, the application is
deemed approved, but IRB approval would still be required before
a study could begin. Products that are not significant risk
devices are deemed to be non-significant risk
devices under FDA regulations, and are subject to
abbreviated IDE requirements, including informed consent, IRB
approval of the proposed clinical trial, and submitting certain
reports to the IRB. Clinical trials are subject to extensive
recordkeeping and reporting requirements. Our clinical trials
must be conducted under the oversight of an IRB at each clinical
study site and in accordance with applicable regulations and
policies including, but not limited to, the FDAs good
clinical practice, or GCP, requirements.
Continuing
FDA Regulation
After a device is placed on the market, numerous regulatory
requirements apply. These include, among others:
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Quality System Regulations, which require manufacturers to have
a quality system for the design, manufacture, packaging,
labeling, storage, installation, and servicing of finished
medical devices;
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labeling regulations, which govern product labels and labeling,
prohibit the promotion of products for unapproved, or off-label,
uses and impose other restrictions on labeling and promotional
activities;
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medical device reporting, or MDR, regulations, which require
that manufacturers report to the FDA if their device may have
caused or contributed to a death or serious injury or
malfunctioned in a way that would likely cause or contribute to
a death or serious injury if it were to recur; and
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recalls and notices of correction or removal.
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MDR Regulations. The MDR regulations require
that we report to the FDA any incident in which our product may
have caused or contributed to a death or serious injury, or in
which our product malfunctioned and, if the malfunction were to
recur, would likely cause or contribute to a death or serious
injury. At December 31, 2006, we had submitted 266 MDRs.
Most of these have been submitted to comply with FDAs
blood loss policy for routine dialysis treatments. This policy
requires manufacturers to file MDR reports related to routine
dialysis treatments if the patient experiences blood loss
greater than 20cc.
FDA Inspections. We have registered with the
FDA as a medical device manufacturer. The FDA seeks to ensure
compliance with regulatory requirements through periodic,
unannounced facility inspections by the FDA, and these
inspections may include the manufacturing facilities of our
subcontractors. Failure to comply
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with applicable regulatory requirements can result in
enforcement action by the FDA, which may include any of the
following:
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warning letters or untitled letters;
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fines, injunctions, and civil penalties;
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administrative detention;
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voluntary or mandatory recall or seizure of our products;
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customer notification, or orders for repair, replacement or
refund;
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operating restrictions, partial suspension or total shutdown of
production;
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refusal to review pre-market notification or pre-market approval
submissions;
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rescission of a substantial equivalence order or suspension or
withdrawal of a pre-market approval; and
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criminal prosecution.
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The FDA has inspected our facility and quality systems three
times. In our first inspection, one observation was made, but
was rectified during the inspection, requiring no further
response from us. Our last two inspections, including our most
recent inspection in March 2006, resulted in no observations. We
cannot provide assurance that we can maintain a comparable level
of regulatory compliance in the future at our facilities.
Foreign
Regulation of Medical Devices
Clearance or approval of our products by regulatory authorities
comparable to the FDA may be necessary in foreign countries
prior to the commencement of marketing of the product in those
countries, whether or not FDA clearance has been obtained. The
regulatory requirements for medical devices vary significantly
from country to country. They can involve requirements for
additional testing and may be time consuming and expensive. We
have not sought approval for our products outside of the United
States, Canada and the European Union. We cannot provide
assurance that we will be able to obtain regulatory approvals in
any other markets.
The System One cycler and related cartridges are regulated as
medical devices in Canada under the Canadian Medical Device
Regulations and in the European Union, or EU, under the Medical
Device Directive. We have received four product licenses from
Canada, although these licenses are not up to date to reflect
the product that is currently being marketed in the United
States. Although we have obtained CE marking approval in the EU
for our System One, this CE marking is not up to date. Before we
would be able to market our current products in the EU, we would
be required to submit additional regulatory documentation. We
are not currently marketing any products in Canada or in the EU.
Anti-Kickback
Statutes
The federal healthcare program Anti-Kickback Statute prohibits
persons from knowingly and willfully soliciting, offering,
receiving or providing remuneration, directly or indirectly, in
exchange for or to induce either the referral of an individual
for, or the furnishing, arranging for or recommending a good or
service for which payment may be made in whole or part under a
federal healthcare program such as Medicare or Medicaid. The
definition of remuneration has been broadly interpreted to
include anything of value, including for example gifts,
discounts, the furnishing of supplies or equipment, credit
arrangements, payments of cash and waivers of payments. Several
courts have interpreted the statutes intent requirement to
mean that if any one purpose of an arrangement involving
remuneration is to induce referrals or otherwise generate
business involving goods or services reimbursed in whole or in
part under federal healthcare programs, the statute has been
violated. The law contains a few statutory exceptions, including
payments to bona fide employees, certain discounts and certain
payments to group purchasing organizations. Violations can
result in significant penalties, imprisonment and exclusion from
Medicare, Medicaid and other federal healthcare programs.
Exclusion of a manufacturer would
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preclude any federal healthcare program from paying for its
products. In addition, kickback arrangements can provide the
basis for an action under the Federal False Claims Act, which is
discussed in more detail below.
The Anti-Kickback Statute is broad and potentially prohibits
many arrangements and practices that are lawful in businesses
outside of the healthcare industry. Recognizing that the
Anti-Kickback Statute is broad and may technically prohibit many
innocuous or beneficial arrangements, the Office of Inspector
General of Health and Human Services, or OIG, issued a series of
regulations, known as the safe harbors, beginning in July 1991.
These safe harbors set forth provisions that, if all the
applicable requirements are met, will assure healthcare
providers and other parties that they will not be prosecuted
under the Anti-Kickback Statute. The failure of a transaction or
arrangement to fit precisely within one or more safe harbors
does not necessarily mean that it is illegal or that prosecution
will be pursued. However, conduct and business arrangements that
do not fully satisfy each applicable safe harbor may result in
increased scrutiny by government enforcement authorities such as
the OIG. Arrangements that implicate the Anti-Kickback Law, and
that do not fall within a safe harbor, are analyzed by the OIG
on a
case-by-case
basis.
Government officials have focused recent enforcement efforts on,
among other things, the sales and marketing activities of
healthcare companies, and recently have brought cases against
individuals or entities with personnel who allegedly offered
unlawful inducements to potential or existing customers in an
attempt to procure their business. Settlements of these cases by
healthcare companies have involved significant fines
and/or
penalties and in some instances criminal pleas.
In addition to the Federal Anti-Kickback Law, many states have
their own kickback laws. Often, these laws closely follow the
language of the federal law, although they do not always have
the same exceptions or safe harbors. In some states, these
anti-kickback laws apply with respect to all payors, including
commercial health insurance companies.
False
Claims Laws
Federal false claims laws prohibit any person from knowingly
presenting, or causing to be presented, a false claim for
payment to the federal government or knowingly making, or
causing to be made, a false statement to get a false claim paid.
Manufacturers can be held liable under false claims laws, even
if they do not submit claims to the government, if they are
found to have caused submission of false claims. The Federal
Civil False Claims Act also includes whistle blower provisions
that allow private citizens to bring suit against an entity or
individual on behalf of the United States and to recover a
portion of any monetary recovery. Many of the recent highly
publicized settlements in the healthcare industry related to
sales and marketing practices have been cases brought under the
False Claims Act. The majority of states also have statutes or
regulations similar to the federal false claims laws, which
apply to items and services reimbursed under Medicaid and other
state programs, or, in several states, apply regardless of the
payor. Sanctions under these federal and state laws may include
civil monetary penalties, exclusion of a manufacturers
products from reimbursement under government programs, criminal
fines, and imprisonment.
Privacy
and Security
The Health Insurance Portability and Accountability Act of 1996,
or HIPAA, and the rules promulgated thereunder require certain
entities, referred to as covered entities, to comply with
established standards, including standards regarding the privacy
and security of protected health information, or PHI. HIPAA
further requires that covered entities enter into agreements
meeting certain regulatory requirements with their business
associates, as such term is defined by HIPAA, which, among other
things, obligate the business associates to safeguard the
covered entitys PHI against improper use and disclosure.
While not directly regulated by HIPAA, a business associate may
face significant contractual liability pursuant to such an
agreement if the business associates breaches the agreement or
causes the covered entity to fail to comply with HIPAA. In the
course of our business operations, we have entered into several
business associate agreements with certain of our customers that
are also covered entities. Pursuant to the terms of these
business associate agreements, we have agreed, among other
things, not to use or further disclose the covered entitys
PHI except as permitted or required by the agreements or as
required by law, to use reasonable safeguards to prevent
prohibited disclosure of such PHI and to report to the covered
entity
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any unauthorized uses or disclosures of such PHI. Accordingly,
we incur compliance related costs in meeting HIPAA-related
obligations under business associate agreements to which we are
a party. Moreover, if we fail to meet our contractual
obligations under such agreements, we may incur significant
liability.
In addition, HIPAAs criminal provisions could potentially
be applied to a non-covered entity that aided and abetted the
violation of, or conspired to violate HIPAA, although we are
unable at this time to determine conclusively whether our
actions could be subject to prosecution in the event of an
impermissible disclosure of health information to us. Also, many
state laws regulate the use and disclosure of health
information, and are not necessarily preempted by HIPAA, in
particular those laws that afford greater protection to the
individual than does HIPAA. Finally, in the event we change our
business model and become a HIPAA covered entity, we would be
directly subject to HIPAA, its rules and its civil and criminal
penalties.
Chronic
Care
Medicare regulations require that all chronic ESRD patients be
under the care of a dialysis clinic, whether they are treated at
home or in-clinic. We rent or sell our System One to dialysis
clinics; these clinics are, in turn, reimbursed by Medicare,
Medicaid and private insurers. According to the 2005 USRDS
report, Medicare is the primary payor for approximately 81% of
patients using hemodialysis and PD. It is believed that 15% of
patients are covered by commercial insurance, with the remaining
4% of patients classified by the USRDS as other or
unknown. Certain centers have reported that the
NxStage daily home dialysis therapy attracts a higher percentage
of commercial insurance patients than other forms of dialysis.
Medicare. Medicare generally provides health
insurance coverage for persons who are age 65 or older and
for persons who are completely disabled. For ESRD patients,
however, Medicare coverage is not dependent on age or
disability. For patients eligible for Medicare based solely on
ESRD, generally patients under age 65, Medicare eligibility
begins three months after the month in which the patient begins
dialysis treatments. During this three-month waiting period
either Medicaid, private insurance or the patient is responsible
for payment for dialysis services. Medicare generally waives
this waiting period for individuals who participate in a
self-care dialysis training program, or are hospitalized for a
kidney transplant and the surgery occurs within a specified time
period.
For ESRD patients under age 65 who have any employer group
health insurance coverage, regardless of the size of the
employer or the individuals employment status, Medicare
coverage is generally secondary to the employer coverage during
the 30-month
period that follows the establishment of Medicare eligibility or
entitlement based on ESRD. During the period, the patients
existing insurer is responsible for paying primary benefits at
the rate specified in the plan, which may be a negotiated rate
or the healthcare providers usual and customary rate. As
the secondary payor during this period, Medicare will make
payments up to the applicable composite rate for dialysis
services reimbursed based on the composite rate to supplement
any primary payments by the employer group health plan if the
plan covers the services but pays only a portion of the charge
for the services.
Medicare generally is the primary payor for ESRD patients after
the 30-month
period. Under current rules, Medicare is also the primary payor
for ESRD patients during the
30-month
period under certain circumstances. Medicare remains the primary
payor when an individual becomes eligible for Medicare on the
basis of ESRD if, (1) the individual was already
age 65 or over or was eligible for Medicare based on
disability and (2) the individuals private insurance
coverage is not by reason of current employment or, if it is,
the employer has fewer than 20 employees in the case of
eligibility by reason of age, or fewer than 100 employees in the
case of eligibility by reason of disability. The rules regarding
entitlement to primary Medicare coverage when the patient is
eligible for Medicare on the basis of both ESRD and age, or
disability, have been the subject of frequent legislative and
regulatory changes in recent years and there can be no assurance
that these rules will not be unfavorably changed in the future.
When Medicare is the primary payor for services furnished by
dialysis clinics, it reimburses dialysis clinics for 80% of the
composite rate, leaving the secondary insurance or the patient
responsible for the remaining 20%. The Medicare composite rate
is set by Congress and is intended to cover virtually all costs
associated with each dialysis treatment, excluding physician
services and certain separately billable drugs and laboratory
services.
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There is some regional variation in the composite rate, but, the
national average for the last three quarters of 2007 is
currently approximately $152 per treatment for independent
clinics and $157 per treatment for hospital-based dialysis
facilities. This is an increase from approximately $149 per
treatment for independent clinics and $154 per treatment
for hospital-based dialysis facilities in 2006, due to two
recent changes in Medicare reimbursement. As a result of
legislation enacted in 2003 and first implemented in 2005, the
Centers for Medicare and Medicaid Services, or CMS, shifted a
portion of Medicare reimbursement dollars for dialysis from
separately billable drugs to the composite rate for dialysis
services. This drug add-on to the composite rate is subject to
an increase based on the estimated rate of growth of drugs and
biologicals. For 2007, an additional 0.5% has been shifted from
separately billable drugs to the composite rate. In addition,
Congress recently passed an additional 1.6% increase to the
composite rate for treatments received on or after April, 2007.
Depending upon patient case mix, reimbursement may be further
improved, based on the case-mix adjustment to the composite rate
implemented as a result of the 2003 legislation. Under the
case-mix adjustment, Medicare now pays more for larger patients
and those under the age of 65. This may be beneficial to our
customers, as to date our patient population has tended to be
younger and larger than the ESRD national average.
CMS rules limit the number of hemodialysis treatments paid for
by Medicare to three per week, unless there is medical
justification for the additional treatments. The determination
of medical justification must be made at the local Medicare
contractor level on a
case-by-case
basis. A clinics decision as to how much it is willing to
spend on dialysis equipment and services will be at least partly
dependent on whether Medicare will reimburse more than three
treatments per week for the clinics patients.
Medicaid. Medicaid programs are
state-administered programs partially funded by the federal
government. These programs are intended to provide coverage for
certain categories of patients whose income and assets fall
below state defined levels and who are otherwise uninsured. For
those who are eligible, the programs serve as supplemental
insurance programs for the Medicare co-insurance portion and
provide certain coverage, for example, self-administered
outpatient prescription medications, that is not covered by
Medicare. For ESRD treatment, state regulations generally follow
Medicare reimbursement levels and coverage without any
co-insurance amounts, which is pertinent mostly for the
three-month waiting period. Certain states, however, require
beneficiaries to pay a monthly share of the cost based upon
levels of income or assets.
Private Insurers. Some ESRD patients have
private insurance that covers dialysis services. Healthcare
providers receive reimbursement for ESRD treatments from the
patient or private insurance during a waiting period of up to
three months before the patient becomes eligible for Medicare.
In addition, if the private payor is an employer group health
plan, it is generally required to continue to make primary
payments for dialysis services during the
30-month
period following eligibility or entitlement to Medicare. In
general, employers may not reduce coverage or otherwise
discriminate against ESRD patients by taking into account the
patients eligibility or entitlement to Medicare benefits.
It is generally believed that private insurance pays
significantly more for dialysis services than Medicare and these
patients with private insurance are generally viewed as more
profitable to dialysis service providers.
Critical
Care
For Medicare patients, both acute kidney failure and fluid
overload therapies provided in an in-patient hospital setting
are reimbursed under a traditional diagnosis related group, or
DRG, system. Under this system, reimbursement is determined
based on a patients primary diagnosis and is intended to
cover all costs of treating the patient. The presence of acute
kidney failure or fluid overload increases the severity of the
primary diagnosis and, accordingly, could increase the amount
reimbursed. The longer hospitalization stays and higher labor
needs, which are typical for patients with acute kidney failure
and fluid overload, must be managed for care of these patients
to be cost-effective. We believe that there is a significant
incentive for hospitals to find a more cost-efficient way to
treat these patients in order to improve hospital economics for
these therapies.
As of July 31, 2007, we had 260 full-time employees, 3
part-time employees and 61 seasonal or temporary employees.
From time to time we also employ independent contractors to
support our engineering, marketing, sales, clinical and
administrative organizations.
91
NxSTAGE
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our
financial condition and results of operations together with our
consolidated financial statements and related notes included
elsewhere in this proxy statement. Some information contained in
this discussion and analysis or set forth elsewhere in this
proxy statement, including information with respect to our plans
and strategy for our business, future events and future
financial performance, includes forward-looking statements that
involve risks and uncertainties. You should review the
Risk Factors section of this proxy statement for a
discussion of important factors that could cause actual result
to differ materially from the results described in or implied by
the forward-looking statements contained in the following
discussion and analysis.
Membrana. In January 2007, we entered into a
long-term supply agreement with Membrana, pursuant to which
Membrana has agreed to supply, on an exclusive basis, capillary
membranes for use in the filters used with the System One for
ten years. In exchange, for Membranas agreement to pricing
reductions based on volumes ordered, we have agreed to purchase
a base amount of membranes per year. The agreement may be
terminated upon a material breach, generally following a
60-day cure
period.
Entrada. On March 13, 2007, we entered
into a long-term agreement with the Entrada Group, or Entrada,
to establish manufacturing and service operations in Mexico,
initially for our cycler and PureFlow SL disposables and later
for our PureFlow SL hardware. The agreement obligates Entrada to
provide us with manufacturing space, support services and a
labor force through 2012.
MDS Stock Purchase. As discussed above, on
June 4, 2007 we entered into a stock purchase agreement
with Mr. Utterberg, who is a member of our board of
directors and owns 6.7% of our outstanding common stock,
pursuant to which we will acquire all of the outstanding equity
of each MDS Entity and each MDS Entity will become a
wholly-owned subsidiary of ours. Mr. Utterberg will receive
6,500,000 shares of our common stock, subject to a
post-closing working capital adjustment as consideration for the
Stock Purchase. In addition, in connection with the Stock
Purchase, we will enter into a consulting agreement with
Mr. Utterberg, pursuant to which he will receive
$200,000 per year, plus expenses, for a period of
two years following the closing of the Stock Purchase.
Product Reliability Issue. In the second
quarter of 2007, we started to experience an increased incidence
of reported dialysate leaks associated with our System One
cartridges. The reported incidence of leaks is higher than we
have historically observed. When the System One is used in
accordance with its instructions, these leaks present no risk to
patient health. System One device labeling anticipates the
potential for leaks to occur and specifically warns against
leaks and alerts users of the need to observe treatments in
order to detect leaks. Four patients with reported leaks, that
were unobserved by these patients or their partners until after
their treatments were terminated, reported hypotension, or low
blood pressure, resolved by a fluid bolus, with no lasting
clinical effect. In early August 2007, we sent a letter to our
patients and customers informing them of the increased incidence
in leaks and reminding them of existing System One labeling
alerting users of the potential for leaks and instructing them
to observe treatments in order to detect any leaks. We have
characterized this notification as a voluntary recall. On
August 24, 2007, we elected to initiate a second step in
our recall actions, and decided to physically recall the
affected lots of cartridge inventory being held by chronic
market customers and patients, and replace the affected
inventory with newer lots of cartridges at no charge. We have
instructed patients and customers to destroy all inventory of
affected cartridges they have on hand, and we expect to
write-off up to all of the inventory of affected cartridges we
have in-house. It is possible that we may be able to rework this
cartridge inventory, or reuse certain components of this
inventory, but we have not made a final determination related to
this recovery.
Based on these facts, we determined on August 24, 2007 that
we would incur total charges in connection with this recall in
the range of $1.9 million to $2.5 million, the
principal component of which relates to the write-off of
inventory in the range of $1.8 million to
$2.2 million. Other charges primarily relate to increased
92
shipping for replacement product and cycler servicing costs.
Substantially all of these charges would be recorded in the
quarter ending September 30, 2007.
The increased incidence in leaks has also been associated with
increased cycler service requirements, which have led to
increased service costs as well as imposed additional service
pool requirements on our cycler inventory. In the short term,
this may impede our ability to meet customer demand.
Resignation of Chief Operating Officer. On
August 28, 2007, Philip R. Licari, our Senior Vice
President and Chief Operating Officer, announced his intention
to resign from NxStage effective upon the completion of the
Stock Purchase.
We are a medical device company that develops, manufactures and
markets innovative systems for the treatment of end-stage renal
disease, or ESRD, acute kidney failure and fluid overload. Our
primary product, the System One, is a small, portable,
easy-to-use hemodialysis system designed to provide physicians
and patients improved flexibility in how hemodialysis therapy is
prescribed and delivered. We believe the largest market
opportunity for our product is the home hemodialysis market for
the treatment of ESRD.
From our inception in 1998 until 2002, our operations consisted
primarily of
start-up
activities, including designing and developing the System One,
recruiting personnel and raising capital. Historically, research
and development costs have been our single largest operating
expense. However, with the launch of the System One in the home
chronic care market, selling and marketing costs became our
largest operating expense in 2005 and this trend continued
during the three and six months ended June 30, 2007 as we
expanded our United States sales force to penetrate our markets
and grow revenues.
Our overall strategy since inception has been to (a) design
and develop new products for the treatment of kidney failure,
(b) establish that the products are safe, effective and
cleared for use in the United States, (c) further enhance
the product design through field experience from a limited
number of customers, (d) establish reliable manufacturing
and sources of supply, (e) execute a market launch in both
the chronic and critical care markets and establish the System
One as a preferred system for the treatment of kidney failure,
(f) obtain the capital necessary to finance our working
capital needs and build our business and (g) achieve
profitability. The evolution of NxStage, and the allocation of
our resources since we were founded, reflects this plan. We
believe we have largely completed steps (a) through (d),
and we plan to continue to pursue the other strategic objectives
described above.
We sell our products in two markets: the chronic care market and
the critical care market. We define the chronic care market as
the market devoted to the treatment of patients with ESRD and
the critical care market as the market devoted to the treatment
of hospital-based patients with acute kidney failure or fluid
overload. We offer a different configuration of the System One
for each market. The United States Food and Drug Administration,
or FDA, has cleared both configurations for hemodialysis,
hemofiltration and ultrafiltration. Our products may be used by
our customers to treat patients suffering from either condition,
although the site of care, the method of delivering care and the
duration of care are sufficiently different that we have
separate marketing and sales efforts dedicated to each market.
We received clearance from the FDA in July 2003 to market the
System One for treatment of renal failure and fluid overload
using hemodialysis as well as hemofiltration and
ultrafiltration. In the first quarter of 2003, we initiated
sales of the System One in the critical care market to hospitals
and medical centers in the United States. In late 2003, we
initiated sales of the System One in the chronic care market and
commenced full commercial introduction in the chronic care
market in September 2004 in the United States. At the time of
these early marketing efforts, our System One was cleared by the
FDA under a general indication statement, allowing physicians to
prescribe the System One for hemofiltration, hemodialysis
and/or
ultrafiltration at the location, time and frequency they
considered in the best interests of their patients. Our original
indication did not include a specific home clearance, and we
were not able to promote the System One for home use at that
time. The FDA cleared our System One in June 2005 for
hemodialysis in the home.
93
In March 2006, we received clearance from the FDA to market our
PureFlow SL module as an alternative to the bagged fluid
presently used with our System One in the chronic care market.
This accessory to the System One allows for the automated
preparation of high purity dialysate in the patients home
using ordinary tap water and dialysate concentrate. The PureFlow
SL is designed to help patients with ESRD more conveniently and
effectively manage their home hemodialysis therapy by
eliminating the need for bagged fluids. In July 2006, we
released the PureFlow SL for commercial use and began shipping
the PureFlow SL product. Our experience suggests that our
chronic care home patients will predominantly use our PureFlow
SL module at home and will use bagged fluid for travel and
outside of the home. Bagged fluids will continue to be used in
the critical care market.
Medicare provides comprehensive and well-established
reimbursement in the United States for ESRD. Reimbursement
claims for the System One therapy are typically submitted by the
dialysis clinic or hospital to Medicare and other third-party
payors using established billing codes for dialysis treatment
or, in the critical care setting, based on the patients
primary diagnosis. Expanding Medicare reimbursement over time to
cover more frequent therapy could accelerate our market
penetration and revenue growth in the future.
Our System One is produced through internal and outsourced
manufacturing. We purchase many of the components and
subassemblies included in the System One, as well as the
disposable cartridges used in the System One, from third-party
manufacturers, some of which are single source suppliers. In
addition to outsourcing with third-party manufacturers, we
assemble, package and label a quantity of disposable products in
our leased facilities in Lawrence, Massachusetts and North
Andover, Massachusetts as well as in our facilities in Mexico
provided to us by the Entrada Group. NxStage GmbH &
Co. KG, our wholly-owned German subsidiary, is the sole
manufacturer of the dialyzing filter that is a component of the
disposable cartridge used in the System One and the ultrafilter
used in the PureFlow SL.
We market the System One through a direct sales force in the
United States primarily to dialysis clinics and hospitals, and
we expect revenues to continue to increase in the near future.
Our revenues were $10.0 million for the three months ended
June 30, 2007, a 121% increase from revenues of
$4.5 million in the three months ended June 30, 2006,
and a 20% increase from revenues of $8.4 million in the
first quarter of 2007. Our revenues were $18.4 million for
the six months ended June 30, 2007, a 132% increase from
revenues of $7.9 million in the six months ended
June 30, 2006. We have increased the number of sales
representatives in our combined sales force from 27 at
June 30, 2006 to 31 at June 30, 2007. During the
remainder of 2007, we expect to add additional sales and
marketing personnel as needed for the remainder of 2007. As of
June 30, 2007, 1,615 ESRD patients were using the System
One at 265 dialysis clinics, compared to 663 ESRD patients at
126 dialysis clinics as of June 30, 2006, and compared to
1,022 ESRD patients at 174 dialysis clinics as of
December 31, 2006. In addition, as of June 30, 2007,
93 hospitals were using the System One for critical care
therapy, compared to 58 and 77 hospitals as of June 30,
2006 and December 31, 2006, respectively.
The following table sets forth the amount and percentage of
revenues derived from each market for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2007
|
|
|
|
|
|
2006
|
|
|
|
|
|
2007
|
|
|
|
|
|
2006
|
|
|
|
|
|
Chronic care
|
|
$
|
6,746,054
|
|
|
|
67.3
|
%
|
|
$
|
2,665,075
|
|
|
|
58.6
|
%
|
|
$
|
12,180,750
|
|
|
|
66.2
|
%
|
|
$
|
4,482,200
|
|
|
|
56.4
|
%
|
Critical care
|
|
|
3,285,130
|
|
|
|
32.7
|
%
|
|
|
1,881,198
|
|
|
|
41.4
|
%
|
|
|
6,224,427
|
|
|
|
33.8
|
%
|
|
|
3,464,795
|
|
|
|
43.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
10,031,184
|
|
|
|
100.0
|
%
|
|
$
|
4,546,273
|
|
|
|
100.0
|
%
|
|
$
|
18,405,177
|
|
|
|
100.0
|
%
|
|
$
|
7,946,995
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We have not been profitable since inception, and we expect to
incur net losses for the foreseeable future as we expand our
sales efforts and grow our operations. Our accumulated deficit
at June 30, 2007 was $148.5 million. Our goal is to
increase our sales volume and revenues to gain scale of
operation and to drive product cost reductions, which we
believe, when combined with other design improvements, will
allow us to reach profitability. We expect our revenues in the
chronic care market to increase faster than those in the
critical care market and believe they will continue to represent
the majority of our revenues.
94
Our product consists of the System One, an electromechanical
device used to circulate the patients blood during therapy
(the cycler); a single-use, disposable cartridge, which contains
a preattached dialyzer, and dialysate fluid used in our therapy,
sold either in premixed bags or prepared with our PureFlow SL
module. We distribute our products in two markets: the chronic
care market and the critical care market. We define the chronic
care market as the market devoted to the treatment of ESRD
patients in the home and the critical care market as the market
devoted to the treatment of hospital-based patients with acute
kidney failure or fluid overload. We offer a different
configuration of the System One for each market. The FDA has
cleared both configurations for hemodialysis, hemofiltration and
ultrafiltration. Our product may be used by our customers to
treat patients suffering from either condition and we have
separate marketing and sales efforts dedicated to each market.
We derive our revenue from the sale and rental of equipment and
the sale of the related disposable products. In the critical
care market, we generally sell the System One and disposables to
hospital customers. In the chronic care market, customers rent
or purchase the machine and then purchase the related disposable
products based on a specific patient prescription. We generally
recognize revenue when a product has been delivered to our
customer, or, in the chronic care market, for those customers
that rent the System One, we recognize revenue on a monthly
basis in accordance with a contract under which we supply the
use of a cycler and the amount of disposables needed to perform
a set number of dialysis therapy sessions during a month. For
customers that purchase the System One in the chronic care
market, we recognize revenue from the equipment sale ratably
over the expected service obligation period, while disposable
product revenue is recognized upon delivery.
Our rental contracts with dialysis centers for ESRD patients
generally include terms providing for the sale of disposable
products to accommodate up to 26 treatments per month per
patient and the purchase or monthly rental of System One cyclers
and, in the majority of instances, our PureFlow SL module. These
contracts typically have a term of one year and are cancelable
at any time by the dialysis clinic with 30 days
notice. Under these contracts, if home hemodialysis is
prescribed, supplies are shipped directly to patient homes and
paid for by the treating dialysis clinic. We also include
vacation delivery terms, providing for the free shipment of
products to a designated vacation destination. We derive an
insignificant amount of revenues from the sale of ancillary
products, such as extra lengths of tubing. Over time, as more
chronic patients are treated with the System One and more
systems are placed in patient homes under monthly agreements
that provide for the rental of the machine and the purchase of
the related disposables, we expect this recurring revenue stream
to continue to grow.
In the first quarter of 2007, we entered into long-term
contracts with three larger dialysis chains, including DaVita,
which was our largest customer during the three months ended
June 30, 2007. Revenues from DaVita represented
approximately 30% of our revenues during the three months ended
June 30, 2007, and we expect revenue from DaVita will
continue to account for a significant portion of our revenues
for the remainder of 2007. Each of these agreements has a term
of at least three years, and may be cancelled upon a material
breach, subject to certain curing rights. These contracts
provide the customer the option to purchase as well as rent the
System One equipment, and, in the case of the DaVita contract,
DaVita has agreed to purchase rather than rent a significant
percentage of its future System One equipment needs. It is not
clear what percentage of our customers, if any, will migrate to
this model, and we expect, at least in the near term, that the
majority of our customers will continue to rent the System One
in the chronic care market.
Cost of revenues consists primarily of direct product costs,
including material and labor required to manufacture our
products, service of System One equipment that we rent and sell
to customers, production overhead and stock-based compensation.
The cost of our products depends on several factors, including
the efficiency of our manufacturing operations, the cost at
which we can obtain labor and products from third party
suppliers, product reliability and related servicing costs and
the design of the products.
95
We are currently operating at negative gross profit as we
continue to build a base of recurring revenue and reduce product
costs. We expect the cost of revenues as a percentage of
revenues to decline over time for several reasons. First, we
continue to realize increased sales volume and realization of
economies of scale that are bringing improved purchasing terms
and prices, and we are realizing economies of scale that are
providing us with broader options and efficiencies in indirect
manufacturing overhead costs. Second, we have introduced, and
are continuing to introduce, several process and product design
changes, such as our new PureFlow SL module, that are expected
to have inherently lower cost than our current products. Third,
through our relationship with the Entrada Group, we opened a
facility that will move the manufacture of certain of our
products, including the System One cycler and certain
disposables, to lower labor cost markets. Fourth, we are working
to improve product reliability. And finally, we continue to look
for opportunities to vertically integrate the manufacture of our
products that will lead to lower cost, such as with the pending
Medisystems acquisition.
Selling and Marketing. Selling and marketing
expenses consist primarily of salary, benefits and stock-based
compensation for sales and marketing personnel, travel,
promotional and marketing materials and other expenses
associated with providing clinical training to our customers.
Included in selling and marketing are the costs of clinical
educators, usually nurses, we employ to teach our customers
about our products and prepare our customers to instruct their
patients in the operation of the System One. We anticipate that
selling and marketing expenses will continue to increase as we
broaden our marketing initiatives to increase public awareness
of the System One in the chronic care market and as we add
additional sales and marketing personnel.
Research and Development. Research and
development expenses consist primarily of salary, benefits and
stock-based compensation for research and development personnel,
supplies, materials and expenses associated with product design
and development, clinical studies, regulatory submissions,
reporting and compliance and expenses incurred for outside
consultants or firms who furnish services related to these
activities. We expect limited research and development expense
increases in the foreseeable future as we continue to improve
and enhance our core products.
Distribution. Distribution expenses include
the freight cost of delivering our products to our customers or
our customers patients, depending on the market and the
specific agreement with our customers, and salary, benefits and
stock-based compensation for distribution personnel. We use
common carriers and freight companies to deliver our products,
and we do not operate our own delivery service. Also included in
this category are the expenses of shipping products from
customers back to our service center for repair if the product
is under warranty, and the related expense of shipping a
replacement product to our customers. We expect that
distribution expenses will increase at a lower rate than revenue
due to expected efficiencies gained from increased business
volume, improvements in product reliability, and the continued
penetration of our PureFlow SL module in the chronic market,
which significantly reduces the weight and quantity of monthly
disposable shipments.
General and Administrative. General and
administrative expenses consist primarily of salary, benefits
and stock-based compensation for our executive management, legal
and finance and accounting staff, fees for outside legal
counsel, fees for our annual audit and tax services and general
expenses to operate the business, including insurance and other
corporate-related expenses. Rent, utilities and depreciation
expense are allocated to operating expenses based on personnel
and square footage usage. We expect that general and
administrative expenses will increase in the near term as we add
additional administrative support for our growing business.
96
The following table presents, for the periods indicated,
information expressed as a percentage of revenues. This
information has been derived from our condensed consolidated
statements of operations included elsewhere in this proxy
statement. You should not draw any conclusions about our future
results from the results of operations for any period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Revenues
|
|
|
100
|
%
|
|
|
100
|
%
|
|
|
100
|
%
|
|
|
100
|
%
|
Cost of revenues
|
|
|
115
|
|
|
|
132
|
|
|
|
116
|
|
|
|
137
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (deficit)
|
|
|
(15
|
)
|
|
|
(32
|
)
|
|
|
(16
|
)
|
|
|
(37
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
51
|
|
|
|
83
|
|
|
|
54
|
|
|
|
87
|
|
Research and development
|
|
|
14
|
|
|
|
35
|
|
|
|
16
|
|
|
|
42
|
|
Distribution
|
|
|
30
|
|
|
|
33
|
|
|
|
29
|
|
|
|
35
|
|
General and administrative
|
|
|
25
|
|
|
|
47
|
|
|
|
28
|
|
|
|
52
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
120
|
|
|
|
198
|
|
|
|
127
|
|
|
|
216
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(135
|
)
|
|
|
(230
|
)
|
|
|
(143
|
)
|
|
|
(253
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
9
|
|
|
|
13
|
|
|
|
10
|
|
|
|
15
|
|
Interest expense
|
|
|
(2
|
)
|
|
|
(12
|
)
|
|
|
(2
|
)
|
|
|
(9
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7
|
|
|
|
1
|
|
|
|
8
|
|
|
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(128
|
)%
|
|
|
(229
|
)%
|
|
|
(135
|
)%
|
|
|
(247
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparison
of Three and Six Months Ended June 30, 2007 to Three and
Six Months Ended June 30, 2006
Revenues
Our revenues for the three and six months ended June 30,
2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Revenues
|
|
$
|
10,031
|
|
|
$
|
4,546
|
|
|
$
|
5,485
|
|
|
|
121
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Revenues
|
|
$
|
18,405
|
|
|
$
|
7,947
|
|
|
$
|
10,458
|
|
|
|
132
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in revenues for both the three and six months ended
June 30, 2007 as compared to the same periods in 2006 was
attributable to increased sales and rentals of the System One in
both the critical care and chronic care markets, primarily as a
result of increased sales and marketing efforts as we continue
our commercial launch of the System One. Revenues in the chronic
care market increased to $6.7 million in the three months
ended June 30, 2007 compared to $2.7 million in the
three months ended June 30, 2006, an increase of 153%,
while revenues in the critical care market increased 75% to
$3.3 million in the three months ended June 30, 2007,
compared to $1.9 million in the three months ended
June 30, 2006. Revenues in the
97
chronic care market increased to $12.2 million during the
six months ended June 30, 2007 compared to
$4.5 million during the six months ended June 30,
2006, an increase of 172%, while revenues in the critical care
market increased 80% to $6.2 million during the six months
ended June 30, 2007, compared to $3.5 million during
the six months ended June 30, 2006.
Cost of
Revenues and Gross Profit (Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Cost of revenues
|
|
$
|
11,511
|
|
|
$
|
6,004
|
|
|
$
|
5,507
|
|
|
|
92
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (deficit)
|
|
$
|
(1,480
|
)
|
|
$
|
(1,457
|
)
|
|
$
|
23
|
|
|
|
2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (deficit) percentage
|
|
|
(15
|
)%
|
|
|
(32
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Cost of revenues
|
|
$
|
21,428
|
|
|
$
|
10,861
|
|
|
$
|
10,567
|
|
|
|
97
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (deficit)
|
|
$
|
(3,023
|
)
|
|
$
|
(2,914
|
)
|
|
$
|
109
|
|
|
|
4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (deficit) percentage
|
|
|
(16
|
)%
|
|
|
(37
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in cost of revenues was attributable primarily to
our increased revenues. We ended June 30, 2007 with
1,615 patients compared to 663 patients ending
June 30, 2006, contributing to an increase in material cost
of revenues of $4.6 million for the quarter ending
June 30, 2007 compared to the same quarter in 2006. In
addition, cost of revenues increased during the three months
ended June 30, 2007 as compared to the three months ended
June 30, 2006 because of a larger employee base that
resulted in additional salaries, health benefits and payroll
taxes of $647, 000, increased inbound freight costs of $427,000
to support our higher production volume, offset by $392,000 of
favorable materials cost due to volume based supplier contacts.
We added 593 net patients during the six months ended
June 30, 2007 to arrive at 1,615 patients compared to
663 patients ending June 30, 2006, contributing to an
additional material cost of revenues of $8.5 million
compared to the same period in 2006. In addition, cost of
revenues increased during the six months ended June 30,
2007 as compared to the six months ended June 30, 2006
because of a larger employee base which resulted in additional
salaries, health benefits and payroll taxes of
$1.5 million, and increased inbound freight costs of
$825,000 to support our higher production volume, offset by
$615,000 of favorable materials cost due to volume based
supplier contracts. We continue to see incremental improvement
in our direct product costs; however, this is currently being
offset somewhat by an increase in disposables per patient due to
product reliability issues. We expect that over time as our
reliability improves, the disposables per patient will decline.
Selling
and Marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Selling and marketing
|
|
$
|
5,120
|
|
|
$
|
3,759
|
|
|
$
|
1,361
|
|
|
|
36
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing as a
percentage of revenues
|
|
|
51
|
%
|
|
|
83
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
98
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Selling and marketing
|
|
$
|
9,851
|
|
|
$
|
6,952
|
|
|
$
|
2,899
|
|
|
|
42
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing as a
percentage of revenues
|
|
|
54
|
%
|
|
|
87
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in selling and marketing expenses was the result of
several factors. For the three months ended June 30, 2007
compared to the same period in 2006, approximately
$1.1 million of the increase was due to additional
salaries, health benefits and payroll taxes resulting from
increased headcount and $236,000 related to a higher level of
sales and marketing activity in both the chronic and critical
care markets. We increased our combined sales force from 27
sales representatives as of June 30, 2006 to 31 sales
representatives as of June 30, 2007. For the six months
ended June 30, 2007 compared to the same period in 2006,
approximately $2.4 million of the increase was due to
additional salaries, health benefits and payroll taxes resulting
from increased headcount and $524,000 related to a higher level
of sales and marketing activity in both the chronic and critical
care markets. We anticipate that selling and marketing expenses
will continue to increase in absolute dollars as we broaden our
marketing initiatives to increase public awareness of the System
One in the chronic care market and as we add additional sales
and marketing personnel.
Research
and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Decrease
|
|
|
Decrease
|
|
|
|
(In thousands, except percentages)
|
|
|
Research and development
|
|
$
|
1,418
|
|
|
$
|
1,576
|
|
|
$
|
(158
|
)
|
|
|
(10
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development as a
percentage of revenues
|
|
|
14
|
%
|
|
|
35
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Decrease
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Research and development
|
|
$
|
2,854
|
|
|
$
|
3,355
|
|
|
$
|
(501
|
)
|
|
|
(15
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development as a
percentage of revenues
|
|
|
16
|
%
|
|
|
42
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in research and development expenses during the
three months ended June 30, 2007 compared to the same
period in 2006 was attributable to $71,000 resulting from lower
clinical trial activities, decrease in salary, benefits and
payroll taxes of $51,000 as a result of decreased headcount, and
a $30,000 decrease in consulting costs relating to the
development of the Pure Flow SL module. The decrease in research
and development expenses during the six months ended
June 30, 2007 compared to the same period in 2006 was
attributable to $247,000 of lower development costs associated
with our PureFlow SL module, decreased salary, benefits and
payroll taxes of $175,000 as a result of decreased headcount,
and a decrease of $54,000 resulting from lower clinical trial
activities. We expect research and development expenses will
increase in the foreseeable future as we seek to further enhance
our System One and related products, and their reliability, but
we do not expect that research and development expenses will
increase as rapidly as other expense categories as we have
substantially completed basic development of the System One. We
expect research and development expenses to continue to decline
as a percentage of revenues.
99
Distribution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Distribution
|
|
$
|
2,997
|
|
|
$
|
1,519
|
|
|
$
|
1,478
|
|
|
|
97
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distribution as a percentage of
revenues
|
|
|
30
|
%
|
|
|
33
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Distribution
|
|
$
|
5,342
|
|
|
$
|
2,808
|
|
|
$
|
2,534
|
|
|
|
90
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distribution as a percentage of
revenues
|
|
|
29
|
%
|
|
|
35
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in distribution expenses for the three and six
month periods ended June 30, 2007 compared to the same
period in 2006 was due to increased volume of shipments of
disposable products to a growing number of patients in the
chronic care market, and due to product reliability issues. We
expect that distribution expenses will increase at a lower rate
than revenues in the second half of 2007 due primarily to
expected shipping efficiencies gained from increased business
volume and density of customers, the reduction of higher cost
deliveries associated with bagged fluid due to the commercial
launch of our PureFlow SL module, which began in July 2006, and
the use of an outsourced logistics provider located in the
central part of the continental United States.
General
and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
General and administrative
|
|
$
|
2,526
|
|
|
$
|
2,149
|
|
|
$
|
377
|
|
|
|
18
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative as a
percentage of revenues
|
|
|
25
|
%
|
|
|
47
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
Percentage
|
|
|
|
2007
|
|
|
2006
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
General and administrative
|
|
$
|
5,193
|
|
|
$
|
4,124
|
|
|
$
|
1,069
|
|
|
|
26
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative as a
percentage of revenues
|
|
|
28
|
%
|
|
|
52
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in general and administrative expenses during the
three months ended June 30, 2007 compared to the same
period in 2006 was primarily due to an increase of $506,000 of
professional fees and corporate expenses offset by $158,000 in
lower salary and benefits. The increase in general and
administrative expenses during the six months ended
June 30, 2007 compared to the same period in 2006 was
primarily due to an increase of $910,000 of professional fees
and corporate expenses and $112,000 in higher salary and
benefits. We expect that general and administrative expenses
will continue to increase in the near term as we add support
structure for our growing business and as a result of costs
related to operating a public company.
Interest
Income and Interest Expense
Interest income is derived primarily from U.S. government
securities, certificates of deposit, commercial paper and money
market accounts. For the three and six month periods ended
June 30, 2007, interest income
100
increased by $224,000 and $532,000, respectively, due to
increased cash and investment balances resulting from our
follow-on public offering in June 2006 and our sale of stock to
DaVita in February 2007.
For the three and six month periods ended June 30, 2007,
interest expense decreased by $363,000 and $346,000,
respectively, based on the repayment of certain long-term debt
arrangements in the three and six month periods ended
June 30, 2006.
Comparison
of Years Ended December 31, 2006 and 2005
Revenues
Our revenues for 2006 and 2005 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2006
|
|
|
2005
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Revenues
|
|
$
|
20,812
|
|
|
$
|
5,994
|
|
|
$
|
14,818
|
|
|
|
247
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in revenues was attributable to increased sales and
rentals of the System One in both the critical care and chronic
care markets, primarily as a result of an increase in the number
of chronic care patients on therapy resulting from increased
sales and marketing efforts. The number of chronic care patients
on therapy was 1,022 at December 31, 2006 compared to 292
at December 31, 2005. In addition, we added 104 dialysis
clinics in 2006 offering the System One. Revenues in the chronic
care market increased to $12.7 million in 2006 from
$3.2 million in 2005, an increase of 302%, while revenues
in the critical care market increased 186% to $8.1 million
in 2006, compared to $2.8 million in 2005. We added an
additional 27 hospitals in 2006 that offer the System One.
Cost of
Revenues and Gross Profit (Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2006
|
|
|
2005
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Cost of revenues
|
|
$
|
26,121
|
|
|
$
|
9,585
|
|
|
$
|
16,536
|
|
|
|
173
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (deficit)
|
|
$
|
(5,309
|
)
|
|
$
|
(3,591
|
)
|
|
$
|
1,718
|
|
|
|
48
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit percentage
|
|
|
(25.5
|
)%
|
|
|
(59.9
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in cost of revenues was attributable primarily to
our increased sales volume. For the chronic care market, we
added 730 net patients during 2006, which contributed to a
$12.9 million increase in cost of revenues. In addition,
cost of revenues increased during 2006 because of an increase in
manufacturing personnel which resulted in additional salaries,
health benefits and payroll taxes of $1.6 million, higher
servicing costs of $0.8 million and increased inbound
freight costs of $1.1 million to support our higher
production volume. We are currently operating at negative gross
profit as we continue to build our base of recurring revenues.
The improvement in gross margin during 2006 was attributable to
(i) increased sales volume and realization of economies of scale
that led to better purchasing terms and prices, and efficiencies
in indirect manufacturing overhead costs, (ii) lower labor costs
for the manufacture of certain of our products, and (iii)
continued improvement in product reliability. We expect the cost
of revenues as a percentage of revenues to continue to decline
over time for these same reasons. In addition, we expect the new
PureFlow SL to help reduce future costs of our product
offerings. Inventory at December 31, 2006 and
December 31, 2005 has been reduced to net realizable value
through charges to cost of revenues.
101
Selling
and Marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2006
|
|
|
2005
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Selling and marketing
|
|
$
|
14,356
|
|
|
$
|
7,550
|
|
|
$
|
6,806
|
|
|
|
90
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing as a
percentage of revenues
|
|
|
69
|
%
|
|
|
126
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in selling and marketing expenses was the result of
several factors. Approximately $4.6 million of the increase
was due to higher salary and benefits resulting from increased
headcount, $550,000 related to stock-based compensation as a
result of the adoption in January 2006 of Statement of Financial
Accounting Standards, or SFAS, No. 123R,
Share-Based Payment. The increase in selling and
marketing expense was also the result of $1.3 million
related to a higher level of sales and marketing activity in
both the chronic and critical care markets. We increased our
combined sales force from 20 sales representatives at
December 31, 2005 to 24 sales representatives at
December 31, 2006. We anticipate that selling and marketing
expenses will continue to increase in absolute dollars as we
broaden our marketing initiatives to increase public awareness
of the System One in the chronic care market and as we add
additional sales and marketing personnel.
Research
and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2006
|
|
|
2005
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Research and development
|
|
$
|
6,431
|
|
|
$
|
6,305
|
|
|
$
|
126
|
|
|
|
2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development as a
percentage of revenues
|
|
|
31
|
%
|
|
|
105
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in research and development expenses was
attributable to increased salary, benefits and payroll taxes of
$306,000 as a result of increased headcount, approximately
$124,000 of stock-based compensation as a result of the adoption
in January 2006 of SFAS No. 123R, offset by a decrease
of $339,000 of development costs associated with our PureFlow SL
module which we incurred in 2005 that did not recur in 2006. We
expect limited research and development expense increases in the
foreseeable future as a substantial portion of the development
effort on the System One and PureFlow SL has been completed and
future expenditures will be limited to enhancements. We expect
research and development expenses to continue to decline as a
percentage of revenues.
Distribution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2006
|
|
|
2005
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Distribution
|
|
$
|
7,093
|
|
|
$
|
2,059
|
|
|
$
|
5,034
|
|
|
|
244
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distribution as a percentage of
revenues
|
|
|
34
|
%
|
|
|
34
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in distribution expenses in 2006 was due to
increased volume of shipments of disposable products to a
growing number of patients in the chronic care market. We expect
that distribution expenses will increase at a lower rate than
revenues during 2007 due to expected shipping efficiencies
gained from increased business volume and density of customers,
and the reduction of higher cost deliveries associated with
bagged fluid due to the commercial launch of our PureFlow SL
module which began in July 2006.
102
General
and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2006
|
|
|
2005
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
General and administrative
|
|
$
|
8,703
|
|
|
$
|
4,855
|
|
|
$
|
3,848
|
|
|
|
79
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative as a
percentage of revenues
|
|
|
42
|
%
|
|
|
81
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in general and administrative expenses was
primarily due to approximately $2.0 million of stock-based
compensation as a result of the adoption in January 2006 of
SFAS No. 123R, and approximately $1.5 million of
legal and administrative expenses incurred as a result of
operating as a public company. We expect that general and
administrative expenses will continue to increase in absolute
dollars in the near term as we add support structure for our
growing business and as a result of costs related to operating
as a public company.
Interest
Income and Interest Expense
Interest income is derived primarily from U.S. government
securities, certificates of deposit, commercial paper and money
market accounts. For the year ended December 31, 2006,
interest income increased by $2.6 million due to increased
cash and investment balances available for investment resulting
from our initial public offering and follow-on public offering
and, to a lesser degree, higher interest rates.
Interest expense increased during the year ended
December 31, 2006 compared to the same period in 2005 due
to the early payoff of a debt agreement, which resulted in the
early recognition of approximately $434,000 of interest expense
during the second quarter of 2006. We expect interest expense
will continue to increase in the future as a result of our 2006
gross borrowings and continued availability under our equipment
line of credit.
Comparison
of Years Ended December 31, 2005 and 2004
Revenues
Our revenues for 2005 and 2004 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2005
|
|
|
2004
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Revenues
|
|
$
|
5,994
|
|
|
$
|
1,885
|
|
|
$
|
4,109
|
|
|
|
218
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in revenues was attributable to increased sales and
rentals of the System One in both the chronic and critical care
markets, primarily as a result of increased sales and marketing
efforts as we continued our commercial launch of the System One.
Revenues in the chronic care market increased to
$3.2 million in 2005 from $0.6 million in 2004, an
increase of 473%, while revenues in the critical care market
increased 112% to $2.8 million in 2005, compared to
$1.3 million in 2004.
Cost of
Revenues and Gross Profit (Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2005
|
|
|
2004
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Cost of revenues
|
|
$
|
9,585
|
|
|
$
|
3,439
|
|
|
$
|
6,146
|
|
|
|
179
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (deficit)
|
|
$
|
(3,591
|
)
|
|
$
|
(1,554
|
)
|
|
$
|
2,037
|
|
|
|
131
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit percentage
|
|
|
(59.9
|
)%
|
|
|
(82.4
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
103
The increase in cost of revenues was attributable to our
increased sales volume. Contributing to the 2005 negative gross
margin was a lower of cost or market valuation allowance in the
amount of $0.3 million relating to disposable cartridge and
fluid inventory designated for the chronic care market, as well
as service costs of approximately $0.5 million to upgrade
100 older cyclers to meet the specifications of our current
product generation.
Selling
and Marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2005
|
|
|
2004
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Selling and marketing
|
|
$
|
7,550
|
|
|
$
|
3,334
|
|
|
$
|
4,216
|
|
|
|
126
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing as a
percentage of revenues
|
|
|
126
|
%
|
|
|
177
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in selling and marketing expenses was the result of
several factors. Approximately $2.7 million of the increase
was due to higher salary and benefits resulting from increased
headcount, approximately $0.8 million of the increase
related to higher travel expenses and the balance of the
increase was due to a generally higher level of sales and
marketing activity in both the chronic and critical care
markets. We increased our sales force from six sales
representatives as of December 31, 2004, to 20 sales
representatives as of December 31, 2005.
Research
and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2005
|
|
|
2004
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Research and development
|
|
$
|
6,305
|
|
|
$
|
5,970
|
|
|
$
|
335
|
|
|
|
6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development as a
percentage of revenues
|
|
|
105
|
%
|
|
|
317
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in research and development expenses was
attributable to increased salary and benefits of approximately
$840,000 as a result of increased headcount and development
costs associated with our PureFlow SL module, partially offset
by a decrease of approximately $520,000 in clinical trial
expenses due to the completion of the IDE home trial for System
One in 2004.
Distribution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2005
|
|
|
2004
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
Distribution
|
|
$
|
2,059
|
|
|
$
|
495
|
|
|
$
|
1,564
|
|
|
|
316
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distribution as a percentage of
revenues
|
|
|
34
|
%
|
|
|
26
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in distribution expenses was due to increased
volume of shipments of disposable products to a growing number
of patients in the chronic market. We expect that distribution
expenses will increase at a lower rate than revenues due to
expected efficiencies from increased business volume and the use
of an outsourced logistics provider located in the central part
of the continental United States.
104
General
and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
Percentage
|
|
|
|
2005
|
|
|
2004
|
|
|
Increase
|
|
|
Increase
|
|
|
|
(In thousands, except percentages)
|
|
|
General and administrative
|
|
$
|
4,855
|
|
|
$
|
3,604
|
|
|
$
|
1,251
|
|
|
|
35
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative as a
percentage of revenues
|
|
|
81
|
%
|
|
|
191
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in general and administrative expenses was
primarily due to an increase in salary and benefits as a result
of the addition of four employees to headcount as well as the
adoption of a management bonus plan in 2005.
Interest
Income and Interest Expense
Interest income is derived primarily from U.S. government
securities, certificates of deposit and money market accounts.
For the year ended December 31, 2005, interest income
increased to $0.6 million from $0.1 million in 2004
primarily due to increased cash and investment balances after
our initial public offering and slightly higher interest rates
in 2005.
Interest expense relates to a debt agreement signed in December
2004. Interest expense increased from $15,000 to $763,000, or
approximately $748,000 in 2005 compared to 2004 due to this
indebtedness being outstanding for a full calendar year.
Liquidity
and Capital Resources
We have operated at a loss since our inception in 1998. As of
June 30, 2007, our accumulated deficit was
$148.5 million and we had cash, cash equivalents and
short-term investments of approximately $53.0 million. On
February 7, 2007, we issued and sold 2,000,000 shares
of common stock to DaVita in which we received net proceeds,
after deducting legal expenses, of approximately
$19.9 million. On June 14, 2006, we closed a follow-on
public offering in which we received net proceeds after
deducting underwriting discounts, commissions and expenses of
approximately $51.4 million from the sale and issuance of
6,325,000 shares of common stock.
On May 15, 2006, we entered into an equipment line of
credit agreement for the purpose of financing field equipment
purchases and placements. The line of credit agreement provides
for the availability of up to $20.0 million through
December 31, 2007, and borrowings bear interest at the
prime rate plus 0.5% (8.4% as of June 30, 2007). Under the
line of credit agreement, $10.0 million is available
through December 31, 2006 and a further $10.0 million
is available from January 1, 2007 through December 31,
2007. The availability of the line of credit is subject to a
number of covenants, including maintaining certain levels of
liquidity, adding specified numbers of patients and operating
within net loss parameters. We are also required to maintain
operating
and/or
investment accounts with the lender in an amount at least equal
to the outstanding debt obligation. Borrowings are secured by
all of our assets other than intellectual property and are
payable ratably over a three-year period from the date of each
borrowing. At June 30, 2007, we had outstanding borrowings
of $6.0 million and $11.6 million of borrowings
available under the equipment line of credit.
105
The following table sets forth the components of our cash flows
for the periods indicated (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
Net cash used in operating
activities
|
|
$
|
(26,672
|
)
|
|
$
|
(25,492
|
)
|
Net cash used in investing
activities
|
|
|
(1,981
|
)
|
|
|
(1,223
|
)
|
Net cash provided by (used in)
financing activities
|
|
|
19,801
|
|
|
|
52,573
|
|
Effect of exchange rate changes on
cash
|
|
|
17
|
|
|
|
44
|
|
|
|
|
|
|
|
|
|
|
Net cash flow
|
|
$
|
(8,835
|
)
|
|
$
|
25,902
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used in Operating Activities. For
each of the periods above, net cash used in operating activities
was attributable primarily to net losses after adjustment for
non-cash charges, such as depreciation, amortization and
stock-based compensation expense. Significant uses of cash from
operations include increases in accounts receivable and
increased inventory requirements for production and placements
of the System One, offset by increases in deferred accounts
payable and accrued expenses. Non-cash transfers from inventory
for the placement of rental units with our customers represented
$12.0 million and $7.4 million, respectively, during
the six months ended June 30, 2007 and 2006.
Net Cash Used in Investing Activities. For
each of the periods above, net cash used in investing activities
reflected purchases of property and equipment, primarily for
research and development, information technology, manufacturing
operations and capital improvements to our facilities. Excluded
from these figures is the net cash provided by short-term
investments and marketable securities of $0.9 million
during the six months ended June 30, 2007 and net cash used
of $29.5 million of short-term investments during the six
months ended June 30, 2006.
Net Cash Provided By Financing Activities. Net
cash provided by financing activities reflected
$19.9 million of net proceeds received from the issuance of
common stock to DaVita in February 2007, and $1.3 million
of proceeds from the exercise of stock options and warrants
during the six months ended June 30, 2007, offset by the
net repayment of debt of $1.4 million and $37,000 during
the six months ended June 30, 2007 and 2006, respectively.
We expect to continue to incur net losses for the foreseeable
future. We expect that our current cash position, and the
availability under our equipment line of credit, is sufficient
to support operations at least through 2007. In the longer term,
we expect to fund the working capital needs of our operations
with revenue generated from product placements and sales, but
these resources may prove insufficient. If our existing
resources are insufficient to satisfy our liquidity
requirements, we may need to sell additional equity or issue
debt securities. Any sale of additional equity or issuance of
debt securities may result in dilution to our stockholders, and
we cannot be certain that additional public or private financing
will be available in amounts or on terms acceptable to us, or at
all. If we are unable to obtain this additional financing when
needed, we may be required to delay, reduce the scope of, or
eliminate one or more aspects of our business development
activities, which could harm the growth of our business. We
anticipate that the pending acquisition with Medisystems, if
consummated, will have a positive effect on our working capital.
The following table summarizes our contractual commitments as of
June 30, 2007 (unaudited) and the effect those commitments
are expected to have on liquidity and cash flow in future
periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
|
|
|
|
|
|
|
Less Than
|
|
|
|
|
|
|
|
|
More Than
|
|
|
|
Total
|
|
|
One Year
|
|
|
1-3 Years
|
|
|
3-5 Years
|
|
|
5 Years
|
|
|
|
(In thousands)
|
|
|
Equipment line of credit
|
|
$
|
6,017
|
|
|
$
|
2,800
|
|
|
$
|
3,217
|
|
|
$
|
|
|
|
$
|
|
|
Operating leases
|
|
|
3,909
|
|
|
|
753
|
|
|
|
1,567
|
|
|
|
1,543
|
|
|
|
46
|
|
Purchase obligations(1)
|
|
|
40,674
|
|
|
|
22,401
|
|
|
|
10,131
|
|
|
|
2,442
|
|
|
|
5,700
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
50,600
|
|
|
$
|
25,954
|
|
|
$
|
14,915
|
|
|
$
|
3,985
|
|
|
$
|
5,746
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
106
|
|
|
(1) |
|
Purchase obligations include purchase commitments for System One
components, primarily for equipment and fluids pursuant to
contractual agreements with several of our suppliers. Certain of
these commitments may be extended and/or canceled at our option. |
Summary
of Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and
results of operations are based upon our consolidated financial
statements, which have been prepared in accordance with
U.S. generally accepted accounting principles. The
preparation of these consolidated financial statements requires
us to make significant estimates and judgments that affect the
reported amounts of assets, liabilities, revenues and expenses.
These items are regularly monitored and analyzed by management
for changes in facts and circumstances, and material changes in
these estimates could occur in the future. Changes in estimates
are recorded in the period in which they become known. We base
our estimates on historical experience and various other
assumptions that we believe to be reasonable under the
circumstances. Actual results may differ substantially from our
estimates.
A summary of those accounting policies and estimates that we
believe are most critical to fully understanding and evaluating
our financial results is set forth below. This summary should be
read in conjunction with our consolidated financial statements
and the related notes included elsewhere in this proxy statement.
Revenue
Recognition
We recognize revenues from product sales and services when
earned in accordance with Staff Accounting Bulletin, or SAB,
No. 104, Revenue Recognition, and
Emerging Issues Task Force, or
EITF 00-21,
Revenue Arrangements with Multiple Deliverables.
Revenues are recognized when: (a) there is persuasive
evidence of an arrangement, (b) the product has been
shipped or services and supplies have been provided to the
customer, (c) the sales price is fixed or determinable and
(d) collection is reasonably assured.
Chronic
Care Market
Prior to 2007, we derived revenue in the chronic care market
from short-term rental arrangements with our customers as our
principal business model in the chronic care market. These
rental arrangements, which combine the use of the System One
with a specified number of disposable products supplied to
customers for a fixed amount per month, are recognized on a
monthly basis in accordance with agreed upon contract terms and
pursuant to a binding customer purchase order and fixed payment
terms. Rental arrangements continue to represent the majority of
the arrangements we have with our customers in the chronic care
market.
Beginning in 2007, we entered into long-term customer contracts
to sell System One and PureFlow SL equipment along with the
right to purchase disposable products and service on a monthly
basis. Some of these agreements include other terms such as
development efforts, training, market collaborations, limited
market exclusivity, and volume discounts. The equipment and
related items provided to our customers in these arrangements
are considered a multiple-element sales arrangement pursuant to
EITF 00-21.
When a sales arrangement involves multiple elements, the
deliverables included in the arrangement are evaluated to
determine whether they represent separate units of accounting.
We have determined that we cannot account for the sale of
equipment as a separate unit of accounting. Therefore, fees
received upon the completion of delivery of equipment are
deferred, and recognized as revenue on a straight line basis
over the expected term of our obligation to supply disposables
and service, which is five to seven years. We have deferred both
the unrecognized revenue and direct costs relating to the
delivered equipment, which costs are being amortized over the
same period as the related revenue.
We entered into a national service provider agreement and a
stock purchase agreement with DaVita on February 7, 2007.
Pursuant to
EITF 00-21,
we consider these agreements a single arrangement. In connection
with the stock purchase agreement, DaVita purchased
2,000,000 shares of our common stock for $10.00 per share,
which represented a premium of $1.50 per share, or
$3.0 million over the current market price. We have
107
recorded the $3.0 million premium as deferred revenue and
will recognize this revenue ratably over seven years, consistent
with our equipment service obligation to DaVita. During the
three and six months ended June 30, 2007, we recognized
revenue of $107,000 and $179,000, respectively, associated with
the $3.0 million premium.
Critical
Care Market
In the critical care market, sales are structured as direct
product sales or as a disposables-based program in which a
customer acquires the equipment through the purchase of a
specific quantity of disposables over a specific period of time.
We recognize revenues from direct product sales at the later of
the time of shipment or, if applicable, delivery in accordance
with contract terms. Under a disposables-based program, the
customer is granted the right to use the equipment for a period
of time, during which the customer commits to purchase a minimum
number of disposable cartridges or fluids at a price that
includes a premium above the otherwise average selling price of
the cartridges or fluids to recover the cost of the equipment
and provide for a profit. Upon reaching the contractual minimum
purchases, ownership of the equipment transfers to the customer.
Revenues under these arrangements are recognized over the term
of the arrangement as disposables are delivered. During the
reported periods, the majority of our critical care revenues
were derived from direct product sales.
Our contracts provide for training, technical support and
warranty services to our customers. We recognize training and
technical support revenue when the related services are
performed. In the case of extended warranty, the revenue is
recognized ratably over the warranty period.
Inventory
Valuation
Inventories are valued at the lower of cost or estimated market.
We regularly review our inventory quantities on hand and related
cost and record a provision for excess or obsolete inventory
primarily based on an estimated forecast of product demand for
each of our existing product configurations. We also review our
inventory value to determine if it reflects lower of cost or
market, with market determined based on net realizable value.
Appropriate consideration is given to inventory items sold at
negative gross margins and other factors in evaluating net
realizable value. The medical device industry is characterized
by rapid development and technological advances that could
result in obsolescence of inventory.
Field
Equipment
We amortize field equipment using the straight-line method over
an estimated useful life of five years. We review the estimated
useful life of five years periodically for reasonableness.
Factors considered in determining the reasonableness of the
useful life include industry practice and the typical
amortization periods used for like equipment, the frequency and
scope of service returns, actual equipment disposal rates, and
the impact of planned design improvements. We believe the five
year useful life is appropriate as of June 30, 2007.
Related-Party
Transactions
Medisystems
Supply Arrangement
We purchase completed cartridges, tubing and certain other
components used in the System One disposable cartridge from
Medisystems Corporation, an entity owned by David S. Utterberg,
a member of our Board of Directors and the owner of
approximately 6.7% of our outstanding common stock. We purchased
approximately $2.1 million and $3.8 million during the
three and six months ended June 30, 2007, and
$1.2 million and $1.9 million for the three and six
months ended June 30, 2006, respectively, of goods and
services from this related party. Amounts owed to Medisystems
Corporation totaled $665,000 and $926,000 at June 30, 2007
and December 31, 2006, respectively, and are included in
accounts payable in the accompanying condensed consolidated
balance sheets. At June 30, 2007, we had commitments to
purchase approximately $3.2 million of products from
Medisystems Corporation.
108
On January 4, 2007, we entered into a seven-year Supply
Agreement, which we refer to as the Medisystems Supply
Agreement, with MDS that expires on December 31, 2013.
Prior to entering into the Medisystems Supply Agreement, we
purchased products from MDS through purchase orders. Pursuant to
the terms of the Medisystems Supply Agreement, we will purchase
no less than ninety percent (90%) of our North American
requirements for disposal cartridges, or MDS products, for use
with our System One from MDS.
As further described in this proxy statement, on June 4,
2007, we entered into a stock purchase agreement with
Mr. Utterberg pursuant to which we will acquire all of the
outstanding equity of each MDS Entity and each MDS Entity will
become a direct or indirect wholly-owned subsidiary of ours.
Consistent with the requirements of our Audit Committee Charter,
these transactions were reviewed and approved by our Audit
Committee, which is comprised solely of independent directors,
as well as our board of directors.
Off-Balance
Sheet Arrangements
Since inception we have not engaged in any off-balance sheet
financing activities except for leases which are properly
classified as operating leases and disclosed in the
Liquidity and Capital Resources section above.
Recent
Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements, which addresses the
measurement of fair value where such measure is
required for recognition or disclosure purposes under GAAP.
Among other provisions, SFAS No. 157 includes
(i) a new definition of fair value, (ii) a fair value
hierarchy used to classify the source of information used in
fair value measurements, (iii) new disclosure requirements
of assets and liabilities measured at fair value based on their
level in the hierarchy, and (iv) a modification of the
accounting presumption that the transaction price of an asset or
liability equals its initial fair value. SFAS No. 157
is effective for fiscal years beginning after November 15,
2007 (i.e., beginning in 2008 for NxStage). We are currently
evaluating the impact of SFAS No. 157 on our
consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159,
The Fair Value Option for Financial Assets and
Financial Liabilities Including an amendment of FASB
Statement No. 115, which permits entities to
choose to measure many financial instruments and certain other
items at fair value. SFAS No. 159 is effective as of
the beginning of an entitys first fiscal year that begins
after November 15, 2007. We are currently evaluating if we
will elect the fair value option for any of our eligible
financial instruments and other items.
109
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT NXSTAGES MARKET
RISK
Our investment portfolio consists primarily of high-grade
commercial paper, certificates of deposit and debt obligations
of various governmental agencies. We manage our investment
portfolio in accordance with our investment policy. The primary
objectives of our investment policy are to preserve principal,
maintain a high degree of liquidity to meet operating needs and
obtain competitive returns subject to prevailing market
conditions. Investments are made with a maturity of no more than
180 days. These investments are subject to risk of default,
changes in credit rating and changes in market value. These
investments are also subject to interest rate risk and will
decrease in value if market interest rates increase. Due to the
conservative nature of our investments and relatively short
effective maturities of the debt instruments, we believe
interest rate risk is mitigated. Our investment policy specifies
the credit quality standards for our investments and limits the
amount of exposure from any single issue, issuer or type of
investment.
As of December 31, 2006, we had outstanding debt
obligations of $7.4 million with a floating interest rate
equal to one-half percentage point (0.50%) above the prime rate
(8.75% at December 31, 2006). Movements in market interest
rates could impact the fair value of our debt. As of
December 31, 2006, the carrying amount of our debt
approximated fair value.
Foreign
Currency Exposure
We operate a manufacturing and research facility in Rosdorf,
Germany. We purchase materials for that facility and pay our
employees at that facility in Euros. In addition, we purchase
products for resale in the United States from foreign companies
and have agreed to pay them in currencies other than the
U.S. dollar. We also have contracts with key suppliers that
expose us to foreign currency risks. As a result, our expenses
and cash flows are subject to fluctuations due to changes in
foreign currency exchange rates. In periods when the
U.S. dollar declines in value as compared to the foreign
currencies in which we incur expenses, our foreign-currency
based expenses increase when translated into U.S. dollars.
Although it is possible to do so, we do not currently hedge our
foreign currency since the exposure has not been material to our
historical operating results. A 10% movement in the Euro would
have had an overall impact to the statement of operations of
approximately $633,000 for 2006, which would have been
approximately 1.1% of total annual expenses.
Equity
Security Price Risk
As a matter of policy, we do not invest in marketable equity
securities; therefore, we do not currently have any direct
equity price risk.
There were no material changes in our market risk exposure since
December 31, 2006.
110
MDS is a privately held, medical device company that designs,
manufactures, assembles, imports, exports and distributes
disposables used in dialysis and related blood treatments and
procedures, primarily in the United States. MDS is headquartered
in Seattle, Washington and operates its business in conjunction
with the other MDS Entities, which are collectively referred to
as Medisystems and include:
|
|
|
|
|
MDS Italy, which molds and assembles components for end-products
at a manufacturing facility in Sorbara, Modena, Italy;
|
|
|
|
MDS Mexico, which manufactures and assembles finished goods at a
manufacturing facility located in Tijuana, Baja California,
Mexico; and
|
|
|
|
MDS Services, which provides contract employee services to MDS
from its base operations in Las Vegas, Nevada.
|
Medisystems is also affiliated with the following entities that
are not being acquired by NxStage in the Stock Purchase:
|
|
|
|
|
DSU Medical, which holds the intellectual property relating to
Medisystems products;
|
|
|
|
MRC, which is a research and development facility with an office
outside Chicago, Illinois;
|
|
|
|
MTC, which merged with DSU Medical in May 2007, and had been
responsible for securing intellectual property licenses for the
components utilized in Medisystems products and funding
the research and development activities of MRC; and
|
|
|
|
LSM and ICS, neither of which has operations of significance.
|
Medisystems products address two markets for use: hemodialysis
and apheresis, with hemodialysis historically being the more
significant market. Products are produced through internal and
outsourced manufacturing and are marketed and sold under the
Medisystems brand name, primarily through distributors, to
clinics in the United States. A portion of products are sold to
distributors for resale under the distributors brand name.
Hemodialysis
Market
The market for dialysis equipment and disposables in the United
States has undergone rapid growth since 1972, the year Congress
extended Medicare coverage to all patients, regardless of age,
with ESRD. ESRD, which affects approximately 472,000 people
in the United States, is an irreversible, life-threatening loss
of kidney function that is treated predominantly with dialysis.
Dialysis is a kidney replacement therapy that removes toxins and
excess fluids from the bloodstream and, unless the patient
receives a kidney transplant, is required for the remainder of
the patients life. Over 70% of ESRD patients in the United
States rely on life-sustaining dialysis treatment. Demographic
factors, including an aging population and the increasing
incidence of diabetes and hypertension, two diseases that
typically presage the onset of ESRD, along with increasing life
expectancy due to improved treatment methods, have helped grow
the market for dialysis treatment in the United States.
Hemodialysis, the most widely prescribed form of dialysis,
typically consists of treatments in a clinic three times per
week, with each session lasting three to five hours. The process
involves a range of equipment and supplies. Machinery is
required to pump the blood, prepare and deliver dialysate (a
blood cleansing solution containing salts and glucose), and
generally monitor the system for safe operation. In addition,
dialyzers (filters that act like an artificial kidney),
bloodlines, needles and assorted other items are needed in
dialysis. The industry typically makes a distinction between
equipment, such as the blood pump and delivery
system used in dialysis, and disposables, such as
the dialyzer, blood lines and needles that are usually disposed
of after each use. There is also a range of
consumables used during the process, that include
the
111
dialysate, heparin (a drug used to prevent blood clotting) and
saline (the solution used to prime and rinse the dialyzer).
During the hemodialysis procedure, blood is conducted via
external, single-use, disposable blood tubing, referred to as
bloodlines, through a dialyzer, where toxins and excess fluids
are removed. An arteriovenous, or AV, fistula, which is a
passageway between an artery and a vein, is created using a
special needle set to provide access to the patients blood
stream for the procedure.
Prior to 1981, disposables for use in hemodialysis were custom
designed by each dialysis clinic customer. Medisystems
initial strategy was to create high quality, low cost,
standardized hemodialysis disposables, specifically targeting
the lowest cost disposable bloodlines and needles. In 1981,
Medisystems began offering FDA-approved, standardized blood
tubing sets, AV fistula needle sets and dialysis priming sets.
In 1983, in an effort to control rapidly increasing hemodialysis
costs, the U.S. government changed the reimbursement scheme
for dialysis treatment from a cost-plus reimbursement to the
composite rate structure that remains in place today. The change
had three main effects: shifting the majority of procedure
volumes from hospitals to lower-cost independently-owned
clinics; prompting the consolidation of independently-owned
clinics among a few, large-scale owners as a means of reducing
overhead cost and maximizing profitability; and refocusing the
hemodialysis industry on opportunities to control treatment
delivery costs.
Medisystems, with its focus on high-quality, low-cost,
standardized disposables, was able to take advantage of the
treatment providers need to reduce costs and their
resulting shift from custom disposables to standardized
disposables during the mid-1980s and establish itself as a
leading supplier of bloodlines and needle disposables for
hemodialysis.
Products
for the Hemodialysis Market
Medisystems hemodialysis bloodlines products include the
Readyset High Performance Blood Tubing sets, the first
integrated bloodline sets on the market; and its latest
generation bloodline set, the StreamLine2 Blood Tubing System,
designed to achieve better patient outcomes at lower costs to
clinics.
Medisystems has offered AV fistula needle sets in the United
States since 1981. In 1991, the Occupational Safety and Health
Administration in the United States, or OSHA, issued a
recommendation that encouraged employers to evaluate and
implement devices to improve workplace safety by minimizing the
risk of blood exposure through needle-stick or other injuries
when dealing with blood borne pathogens. That same year,
Medisystems introduced the AV Fistula Needles with PointGuard
Anti-Stick Needle Protectors, the first safety guard for AV
fistula needles marketed in the United States. In 1995,
Medisystems introduced its second generation safety guard,
MasterGuard, which has been shown in a published study to reduce
needlestick injuries. In 2000, the U.S. Congress passed the
Needlestick Safety and Prevention Act, authorizing OSHA to
require employers, including office-based physicians, to select
safer medical devices, including self-sheathing needles.
Most hemodialysis patients require treatment at least three
times a week for the rest of their lives. Clinical experience
demonstrates that the incidence of pain, hematoma, infection and
infiltrations at the needle insertion site can be reduced by
using what is called the constant-site
technique inserting the fistula needle in the
same place each treatment. Medisystems has developed the
Buttonhole Needle Set, an anti-stick, dull bevel needle set
specifically designed for use with this constant-site technique.
Other hemodialysis products that Medisystems manufactures and
sells include:
|
|
|
|
|
safety devices and access management devices, including the
ViraGuard patient-transducer protector, a connection device that
includes a membrane providing protection for hemodialysis
pressure monitors and for maintaining the sterility of the fluid
pathway;
|
|
|
|
the Medic plastic anti-stick needle/connector device, designed
to help reduce the risk of accidental needlesticks;
|
112
|
|
|
|
|
dialysis priming sets, which are used to expel air and set the
solution before connecting to the patient, specifically designed
for hemodialysis that feature needleless access ports, large
inner diameter tubing intended to allow relatively fast and easy
flows, and a unique spike and chamber design to help prevent air
bubbles from entering the line; and
|
|
|
|
the Access Alert Pressure Measurement Filter, for use with
Medisystems AV fistula needles, designed to easily measure
static intra-access pressure.
|
Apheresis
Market
Therapeutic apheresis is a technique for removing harmful
components from a patients blood and is used in the
treatment of autoimmune diseases and other disorders.
Therapeutic apheresis services are generally provided upon the
request of a hospital, which has received an order from a
patients physician. Therapeutic treatments are
administered using blood cell separator equipment and the
disposables needed to perform the procedure.
Therapeutic apheresis is the primary therapy for patients
suffering from:
|
|
|
|
|
Goodpasture syndrome a rare autoimmune disease
affecting the lungs and kidneys;
|
|
|
|
thrombotic thrombocytopenic purpura a
life-threatening blood disease;
|
|
|
|
sickle cell disease an inherited blood disorder
affecting the red blood cells;
|
|
|
|
Guillain-Barre syndrome an autoimmune disorder
affecting the nervous system; and
|
|
|
|
chronic inflammatory demyelinating polyneuropathy a
rare neurological disorder.
|
Therapeutic apheresis is also used as a supportive or adjunct
therapy for patients suffering from diseases such as multiple
myeloma, a cancer of the plasma cells; Lambert-Eaton myasthenic
syndrome, an autoimmune disease causing muscle weakness;
systemic lupus erythematosus, an autoimmune disorder causing
chronic inflammation of connective tissues; and systemic
vasculitis, inflammation of the blood vessels. The main
providers of therapeutic apheresis are regional and community
blood banks, although many dialysis clinics also offer these
services.
Medisystems received its first FDA clearance to market needle
sets used during apheresis procedures in 1986. Its primary
apheresis needle is the Apheresis Needle with MasterGuard
Anti-Stick Needle Protector, designed to protect against needle
sticks immediately upon removal and through time of disposal.
Medisystems also designed its Medic plastic anti-stick
needle/connector for use with apheresis procedures.
Medisystems
Strategy
Medisystems overall strategy since inception has been to
(1) design, develop, and manufacture high quality, low cost
disposables for use in dialysis and blood treatments and
procedures in the United States; (2) continue to enhance
the function of products by continuously innovating the design
and methods for treatment delivery; (3) protect innovations
by patenting designs and methods in the United States and in key
markets worldwide; (4) educate customers on the value of
enhanced product designs; (5) establish reliable
manufacturing and sources of supply; (6) establish reliable
sources of distribution; and (7) maintain sufficient cash
flow and profitability to fund growth in operations without the
need for significant outside capital.
In January 2007, Medisystems entered into a seven-year agreement
with NxStage to supply no less than 90% of their North American
requirements for disposable cartridges for use with their
primary home hemodialysis product, the System One.
In May 2007, MTC merged into DSU Medical, with DSU Medical being
the surviving entity.
113
For the period January 1, 2007 through May 31, 2007,
at the discretion of the sole common stockholder,
Mr. Utterberg, and in contemplation of a renegotiation of
existing agreements, DSU Medical did not charge royalty payments
to MTC, and MTC, in turn, did not charge royalty to MDS.
Effective June 1, 2007, DSU Medical and MDS terminated the
royalty sublicense agreement to MDS for consideration of
$2.7 million to be paid to DSU Medical. A new, royalty-free
license agreement between DSU Medical and MDS was entered into
effective June 1, 2007.
In June 2007, Mr. Utterberg, the common stockholder of the
Medisystems Group, entered into an agreement with NxStage,
pursuant to which NxStage has agreed to purchase the issued and
outstanding shares of MDS, MDS Services, MDS Italy and MDS
Mexico in exchange for 6,500,000 shares of NxStage common
stock, subject to adjustment. The transaction is expected to
close in 2007.
Medisystems manufactures and distributes a number of different
products, including private label products, for use
predominantly in hemodialysis. Its primary sources of revenue
are from blood tubing sets, used for hemodialysis, and needle
sets, used in hemodialysis and apheresis. In 2006, revenues from
blood tubing sets accounted for 56% of Medisystems gross
revenues. Revenues from needle sets accounted for 29%, and
revenues from the sale of products to NxStage accounted for 7%,
of Medisystems gross revenues in 2006.
Readyset
The Readyset High Performance Blood Tubing Sets, which
Medisystems introduced for use in hemodialysis in 1993, feature
a proprietary pump segment and proprietary material designed to
deliver reliable, accurate flows throughout the treatment. The
kink-resistant blood tubing is designed to be easy to handle and
to enable relatively fast priming, or removal of air from the
dialysate solution. These technological advances, along with a
patented process for treatment delivery, are intended to result
in Kt/V, which is the measure for how much waste is removed from
the patients blood during dialysis, that better reflects
the Kt/V prescribed by a patients physician.
StreamLine2
In 2006, Medisystems introduced its latest generation bloodline
product, StreamLine2. The StreamLine2 product line is covered by
a number of U.S. and foreign patents. Also, a number of U.S. and
foreign patent applications have been submitted, though there
can be no assurance any of these applications will be granted.
StreamLine2s airless design and other technologies have
been shown in two clinical studies to result in superior
clinical and economic performance. StreamLine also includes
Medisystems patented LockSite needleless access sites,
eliminating the need for dangerous needles and expensive guarded
needles, improving a clinics ability to meet OSHA
anti-stick requirements.
AV
Fistula and Apheresis Needles with MasterGuard Anti-Stick Needle
Protectors
Medisystems has designed its AV fistula and apheresis needles to
achieve a smooth blood flow throughout the treatment, intended
to result in less clotting, lower pressure drops, and less
stress on the patients blood. In addition, in a published
study, Medisystems AV fistula and apheresis needles with
Masterguard anti-stick needle protectors were shown to
significantly reduce needle stick injuries compared to
conventional, unguarded needles.
ButtonHole
Needle Set
The constant-site technique is used worldwide to insert the
needle in the vascular access site for hemodialysis patients
with native, or human, AV fistulaes. Clinical experience
demonstrates that the incidence of pain, hematoma, infection and
infiltrations at the needle insertion site can be reduced by
utilizing the constant-site technique. Medisystems
ButtonHole AV fistula needle has an anti-stick, dull bevel
design ideally suited for the constant-site technique, while
also reducing the risk of accidental needle sticks.
114
Transducer
Protectors with ViraGuard
Transducer protectors are single-use air filter devices used to
protect hemodialysis pressure monitors during treatments.
Medisystems transducer protectors include the ViraGuard
membrane, designed to maintain the sterility of the fluid
pathway and act as a bacterial and viral barrier as well as a
unique airflow design, intended to allow for a quick response
time with few false alarms.
Medic
The Medic needle/connector device was engineered to help reduce
the risk of accidental needle sticks, as required by OSHA. Medic
performs the functions of a traditional needle but its
precisely-shaped tip is made of plastic. Medic can be used with
any standard syringe, and is used in hemodialysis procedures
with catheters, AV fistula needles, blood tubing sets and
dialysis priming sets. For apheresis procedures, Medic is
designed to easily access drug vials and blood collection tubes.
Access
Alert
Vascular access complications are a leading cause of
complications during dialysis. To facilitate early
identification and intervention for access-related problems,
dialysis clinics have instituted routine measurement and trend
analysis of access pressures. Medisystems has developed the
Access Alert Pressure Measurement Filter for use with
Medisystems AV fistula needles to measure static
intra-access pressure, with no interruption of therapy. These
readings can be used to detect venous, mid-graft and arterial
inflow stenosis, which is the narrowing of a vein or artery that
restricts bloodflow.
System
One Cartridge
Medisystems manufactures the disposable cartridge used in the
System One hemodialysis system. The cartridge is a single-use,
disposable, integrated treatment device that loads simply and
easily into the cycler. The cartridge includes a pre-attached
dialyzer supplied by NxStage. Medisystems manufactures the
components and bloodlines for the cartridge and assembles the
final device. These cartridges are sold under the NxStage brand
name. In 2006, sales of NxStage cartridges represented 7% of
Medisystems gross revenues.
Other
Private Label Products
Medisystems also manufactures bloodlines and Medics for B. Braun
and sells needles to Fenwal Inc. for distribution under their
own respective brand names.
Medisystems primary competitors are a
vertically-integrated chain clinic operator and foreign
manufacturers. Fresenius is the largest manufacturer of dialysis
products and operator of dialysis clinics in the United States.
It represents approximately 32% of the dialysis services market
in the United States and manufactures its own dialysis machines
and disposables. In addition, Fresenius sells equipment and
disposables to non-affiliated dialysis clinics. Gambro
manufactures equipment and disposables for U.S. clinics. Foreign
dialysis product manufacturers, such as Nipro and JMS, also
compete with Medisystems. To the extent these firms successfully
gain market share, this would further limit the available market
for, and potential profitability of, Medisystems products.
The customer and clinic services team at Medisystems markets its
tubing sets and/or blood access devices under the Medisystems
brand name.
To support bloodline and access needle sales, clinic services
personnel regularly visit or call clinic operators, excluding
Fresenius. Clinics owned by Fresenius predominantly use
Fresenius-manufactured bloodlines.
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The majority of sales are made through three major distributors
because Medisystems is able through these distributors to
leverage national networks, shipping efficiencies, and existing
customer relationships. Sales through Medisystems primary
distributor, Schein, accounted for 65% and 66% of net sales for
the years ended December 31, 2006 and 2005, respectively,
and 66% of net sales for the six months ended June 30,
2007. Medisystems contract with Schein was recently
extended through July 2009. Distribution agreements with
Medisystems current second and third most significant
distributors currently expire in October 2008 and
July 2009, respectively.
Medisystems also has a customer agreement with DaVita for
bloodline products that expires in September 2008, and a
separate agreement for needle sets and other products that
expires in December 2007. Distribution of products under both
agreements is fulfilled by Schein, Medisystems primary
distributor.
Medisystems plans production against distributor purchase
orders. Finished goods are shipped directly to distributor
warehouses.
Research and development for existing products is conducted at
MDS and MDS Mexico. As of July 31, 2007, there were
nine Medisystems employees primarily focused on research
and development. In response to physician and patient feedback
and internal assessments, Medisystems is continually working on
enhancements to its product designs to improve ease-of-use,
functionality, reliability and safety.
Research and development expenses for the MDS Entities for the
years ending December 31, 2006, 2005 and 2004, were
$2.3 million, $2.2 million and $1.6 million,
respectively.
Research and development expenses for the MDS Entities for the
six months ended June 30, 2007, and 2006 were $877,000 and
$1.1 million, respectively.
The underlying technology included in the products and
components produced by the MDS Entities is covered by patents
developed and owned by DSU Medical, a separate company owned by
Mr. Utterberg. DSU Medical issues financial statements
separate from the Medisystems Groups combined financial
statements. NxStage will not purchase DSU Medical from
Mr. Utterberg. Through a series of license and sublicense
agreements executed in 1998, DSU Medical granted MTC a
nonexclusive license to this technology, which in turn granted a
nonexclusive sublicense to the technology to MDS. In April 2001,
both the license and sublicense agreements were amended to grant
exclusive rights and license to use certain subject patents
referenced in the original license and sublicense agreements.
These amendments also increased the annual royalty payment,
payable quarterly, in advance, from MDS under the sublicense
agreement from $5,700,000 to $5,800,000. The license agreement,
also executed in October 1998, requires MTC to pay a royalty to
DSU Medical in an amount ranging from 75% to 100% of any
sublicense royalties received by MTC.
For the period January 1, 2007 through May 31, 2007,
DSU Medical, MTC and MDS suspended royalty payments in
contemplation of a renegotiation of the license and sublicense
agreements. In May 2007, MTC merged into DSU Medical, with DSU
Medical being the surviving entity. Effective June 1, 2007
DSU Medical and MDS terminated the royalty sublicense agreement
for consideration of $2,661,000 to be paid to DSU Medical. A new
royalty-free license agreement between DSU Medical and MDS was
entered into effective June 1, 2007. This new license
agreement will survive the Stock Purchase.
The following table lists all of the issued patents licensed by
MDS from DSU Medical that are fundamental to the manufacture and
sale of Medisystems core products and are licensed
pursuant to the license agreement described under the heading
License Agreement and Consulting Agreement beginning
on page 75:
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Subject Matter
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Patent Number
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Patent Expiration
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Pump Segment Having Connected,
Parallel Branch Line
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US 5360395
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11/1/2011
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Pump Segment Having Connected,
Parallel Branch Line: Continuation
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US 6440095
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5/5/2017
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Subject Matter
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Patent Number
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Patent Expiration
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Blood Set Priming
Method & Apparatus
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US 5895368
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9/23/2016
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Blood Set Priming
Method & Apparatus: Div
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US 6290665
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3/11/2018
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Reversing Flow Blood Processing
System
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US 6177409
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6/10/2018
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New Reverso
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US 6695807
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1/18/2022
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Turbo Cap for Blood Processing
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US 6517508
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11/3/2019
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Measuring Vascular Access Pressure
- Access Alert
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US 6346084
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1/10/2020
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Universal Connector - MEDIC
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US 5071413
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12/10/2008
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Guarded Winged Needle Assembly:
File Wrapper Continuation (FWC)
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US 5112311
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5/12/2009
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Guarded Winged Needle Assembly:
FWC-2
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US 5266072
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11/30/2010
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Guarded Winged Needle Assembly
(Method): Div. Of Continuation
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US 5433703
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7/18/2012
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Easy Use Needle Protector Sheath
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US 5704924
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1/11/2016
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European Guarded Winged Needle
Assembly
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EUR 436646
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8/31/2011
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European Guarded Winged Needle
Assembly: Divisional
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EUR 558162
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1/9/2010
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Japan Easy Use Needle Protector
Sheath
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JP 3809563
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12/20/2016
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Luer Connector with Integral
Closure
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US 5385372
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1/31/2012
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Squeeze Clamp for Flexible Tubing
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US 6089527
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10/3/2017
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Squeeze Clamp for Flexible Tubing
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US 6113062
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5/20/2018
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Divisional Squeeze Clamp for
Flexible Tubing
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US 6196519
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9/15/2019
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Canada Squeeze Clamp for Flexible
Tubing
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CN 2308052
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9/22/2018
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Injection Site for Male Luer -
LocksiteTM
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US 7025744
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10/4/2022
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In addition to the above licensed patents, the license agreement
between MDS and DSU Medical includes rights to numerous
patent applications, however, no assurance can be made that any
such patent applications will be granted.
Medisystems products are produced through internal and
outsourced manufacturing. Medisystems contracts for the
manufacture of the majority of its finished goods ReadySet
bloodlines (but no StreamLine2 bloodlines) and all its needles
under supply contracts with Kawasumi Laboratories Inc., or KLT,
headquartered in Tokyo, Japan, with manufacturing facilities in
Thailand. Any disruption in this arrangement could have a
material adverse effect on the Medisystems business.
The current agreement with KLT for the manufacture of bloodlines
expires in June 2008. Under the terms of this agreement, MDS
Italy supplies KLT with molded component parts and KLT in turn
uses these components to manufacture finished goods bloodlines,
which are then purchased by Medisystems. Medisystems has
committed to purchase from KLT a minimum of 80% of an agreed
bloodlines purchase goal over the term of the agreement. KLT and
Medisystems are currently in negotiation to determine if this
current supply agreement for bloodlines will be extended beyond
June 2008.
KLT and Medisystems also have an agreement for the manufacture
of Medisystems needle sets. Virtually all of these needle sets
rely on Medisystems patented guarded needle set
technology. The only other current competitors in the U.S., JMS
and Nipro, have their own needle guard technology. Medisystems
and KLT agreed in February 2007 to extend their needle set
supply agreement through February 2011. Medisystems has
committed to purchase from KLT a minimum of 80% of an agreed
needle set purchase goal over the three-year extended term of
the contract.
MDS Italy molds the components used in Medisystems self
manufacturing as well as components for finished goods
manufactured by KLT for Medisystems. MDS Mexico manufactures all
other bloodlines, including all StreamLine2, Medics, transducer
protectors, and disposable cartridges for NxStage.
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Food
and Drug Administration
Medisystems products are subject to regulation by the FDA as
medical devices. The FDA regulates the clinical testing,
manufacture, labeling, distribution, import and export, sale and
promotion of medical devices. Noncompliance with applicable FDA
requirements can result in, among other things, fines,
injunctions, civil penalties, recall or seizure of products,
total or partial suspension of production, failure of the
government to grant pre-market clearance or pre-market approval
for devices, withdrawal of marketing clearances or approvals and
criminal prosecution.
Unless an exemption applies, all medical devices must receive
either prior 510(k) clearance or pre-market approval from the
FDA before they may be commercially distributed in the United
States. Submissions to obtain 510(k) clearance and pre-market
approval must be accompanied by a user fee, unless exempt. In
addition, the FDA can also impose restrictions on the sale,
distribution or use of devices at the time of their clearance or
approval, or subsequent to marketing.
MDR Regulations The MDR regulations require
that Medisystems report to the FDA any incident in which a
product may have caused or contributed to a death or serious
injury, or in which a product malfunctioned and, if the
malfunction were to recur, would likely cause or contribute to a
death or serious injury. Medisystems has submitted 226 MDRs to
the FDA since 2004. Most of these have been submitted to comply
with the FDAs blood loss policy for routine dialysis
treatments. This policy requires manufacturers to file MDR
reports related to routine dialysis treatments if the patient
experiences blood loss greater than 20cc.
FDA Inspections. Medisystems has registered
with the FDA as a medical device specification developer and
initial importer. The FDA seeks to ensure compliance with
regulatory requirements through periodic, unannounced facility
inspections, and these inspections may include Medisystems
corporate office as well as the manufacturing facilities of
Medisystems contract manufacturers. Failure to comply with
applicable regulatory requirements can result in enforcement
action by the FDA, which may include any of the following:
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warning letters or untitled letters;
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fines, injunctions, and civil penalties;
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administrative detention;
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voluntary or mandatory recall or seizure of Medisystems
products;
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customer notification, or orders for repair, replacement or
refund;
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operating restrictions, partial suspension or total shutdown of
production;
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refusal to review pre-market notification or pre-market approval
submissions;
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rescission of a substantial equivalence order or suspension or
withdrawal of a pre-market approval; and
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criminal prosecution.
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The MDS Italy facility is not required to be registered with the
FDA so is not currently subject to inspection. The MDS Mexico
facility is registered with the FDA as a contract manufacturer
and is subject to inspection. KLT facilities involved in
supplying Medisystems products are registered with the FDA as a
contract manufacturer and are subject to FDA inspection. All FDA
inspections of Medisystems Group facilities have resulted in no
action indicated.
Foreign
Regulation of Medical Devices
Clearance or approval of Medisystems products by regulatory
authorities comparable to the FDA may be necessary in foreign
countries prior to the commencement of marketing of the product
in those countries, whether or not FDA clearance has been
obtained. The regulatory requirements for medical devices vary
significantly from country to country. They can involve
requirements for additional testing and may be time consuming
and expensive. Medisystems has not sought approval for its
products outside of the United States,
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Canada and the European Union, and cannot provide assurance that
it will be able to obtain regulatory approvals in any other
markets.
The Medisystems blood tubing sets, AV fistula needles, apheresis
needles, dialysis priming sets, transducer protectors, Reverso,
and Medic are regulated as medical devices in Canada under the
Canadian Medical Device Regulations and in the European Union,
or EU, under the Medical Device Directive. Medisystems maintains
six Medical Device Licenses with Health Canada for these
products. Medisystems has received CE marketing approval in the
EU for AV fistula needles, apheresis needles, and its Reverso
product. At this time no other Medisystems products have been
approved for CE marketing.
As of July 31, 2007, Medisystems and MDS Services had 29
total full-time employees and one temporary contract employee,
MDS Italy had 42 full-time, seven part-time and
11 temporary contract employees and MDS Mexico had
820 full-time employees. From time to time, Medisystems
employs independent contractors to support engineering,
marketing, sales, regulatory, clinical and administrative
functions.
119
MEDISYSTEMS
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of
Medisystems financial conditions and results of operations
together with the Medisystems Groups combined financial
statements and related notes included elsewhere in this proxy
statement. Some information contained in this discussion and
analysis or set forth elsewhere in this proxy statement,
including information with respect to Medisystems plans
and strategy for its business, future events and future
financial performance, includes forward-looking statements that
involve risks and uncertainties. You should review the
Risk Factors section of this proxy statement for a
discussion of important factors that could cause actual results
to differ materially from the results described in or implied by
the forward-looking statements contained in the following
discussion and analysis.
The MDS
Entities
Medisystems is a medical device company that designs,
manufactures, assembles, imports, exports and distributes
disposables used in dialysis and related blood treatments and
procedures. It is a major supplier of hemodialysis blood tubing
sets, AV fistula needles, apheresis needles and hemodialysis
transducer protectors in the United States. Medisystems is also
the sole supplier for the disposable cartridges used in
connection with the System One. Medisystems and its related
affiliated entities, are owned and controlled, directly or
indirectly, by Mr. Utterberg, and are referred to as the
Medisystems Group.
The MDS Entities, which NxStage will acquire in the Stock
Purchase, comprise the manufacturing, sales and marketing
operations for the Medisystems bloodlines and needles products
businesses. Specifically:
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MDS includes the company headquarters and associated employees
located in Seattle, Washington;
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MDS Italy molds and assemblies components for end-products at a
manufacturing facility located in Sorbara, Modena, Italy;
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MDS Mexico manufactures and assembles finished goods at a
manufacturing facility located in Tijuana, Baja California,
Mexico; and
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MDS Services provides contract employee services to MDS from its
base of operations in Las Vegas, Nevada.
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NxStage is not acquiring the following Medisystems Group
companies: MRC, MTC, LSM and ICS. In addition, NxStage is not
acquiring DSU Medical Corporation, or DSU Medical, which is
wholly-owned by Mr. Utterberg and holds intellectual
property relating to the Medisystems business and products.
The Medisystems Group companies not being acquired by NxStage in
connection with the Stock Purchase are not primarily involved in
the core bloodlines and needles products businesses that NxStage
is acquiring. However, DSU Medical owns intellectual property
relating to these businesses. Pursuant to the license agreement
between MDS and DSU Medical dated June 1, 2007, MDS has a
royalty-free and irrevocable license to this intellectual
property. Accordingly, NxStage will have access to DSU Medical
patents and technologies that are significant to the acquired
blood tubing and hemodialysis business.
The
Medisystems Business
Medisystems products address two markets for use: hemodialysis
and apheresis, with hemodialysis historically being the more
significant market. Products are produced through internal and
outsourced manufacturing and are marketed and sold under the
Medisystems brand name, primarily through distributors, to
clinics in the United States. A portion of products are sold to
distributors for resale under the distributors brand name.
Medisystems hemodialysis products consist primarily of
blood tubing and needle sets. The blood tubing products include
the ReadySet High Performance Blood Tubing Sets and the
StreamLine2 Tubing Sets, both single-use, disposable devices for
use with multiple hemodialysis systems. Medisystems
hemodialysis needle
120
products include the AV Fistula Needles with MasterGuard
Anti-Stick Needle Protectors and the Buttonhole Needle Sets,
which are both single-use patient cannulation devices used
during the hemodialysis procedure. The private label products
include the NxStage disposable cartridge; bloodlines to B. Braun
Medicals Renal Therapy Division; and sterile needle
assemblies to Fenwal Inc. (formerly Baxter Healthcare).
Medisystems apheresis products consist of the Apheresis
Needles with Masterguard Anti-Stick Needle Protectors and the
Medic Plastic Anti-Stick Needle/Connector.
Historically, combined financial statements for the Medisystems
Group have included the MDS Entities, as well as MRC, LSM and
ICS. Prior to June 2007, the combined financial statements also
included MTC. MRC and MTC primarily reflect intercompany
transactions and balances, which have been eliminated in
combination. The operations of LSM and ICS are immaterial.
DSU Medical, which as of June 2007 includes MTC, is not included
in the combined Medisystems Group since its activities are
substantially unrelated to the Medisystems Groups
activities and revenue generated from the Medisystems Group
member companies is not significant in relation to DSUs
revenue, and as such, DSU Medical is not economically dependent
on revenue from the Medisystems Group.
The following discussion and analysis reflects the combined
financials of the Medisystems Group.
Revenues
Medisystems derives the majority of its revenues from supply and
distribution contracts with distributors of its hemodialysis and
apheresis products. Medisystems revenues are highly
concentrated in several significant purchasers of its products.
Revenues from Schein, Medisystems primary distributor,
represented approximately 66% and 65% of Medisystems
revenues as of June 30, 2007 and December 31, 2006,
respectively. Revenues from Medisystems two other primary
distribution relationships accounted for an additional 18% and
25% of revenues as of June 30, 2007 and December 31,
2006. Medisystems most significant customer contract is
with DaVita. Sales to DaVita, fulfilled through the Schein
distributor agreement, accounted for 38% of Medisystems
revenues for 2006. Under that agreement, DaVitas purchase
obligations with respect to needles expires in December 2007,
and its purchase obligations with respect to bloodlines expires
in September 2008. The contractual arrangements with these
distributors and Medisystems other key customers are
described further under the heading Medisystems
Business Sales and Marketing.
Medisystems distribution and customer contracts contain
minimum volume commitments with negotiated pricing triggers at
different volume tiers. Each agreement may be cancelled upon a
material breach, subject to certain curing rights, and in many
instances minimum volume commitments can be reduced or
eliminated upon certain events. In addition to contractually
determined volume discounts, Medisystems offers rebates based on
sales to specific end customers and discount incentives for
payment within 20 days. Medisystems sales revenues
are presented net of these rebates, incentives, discounts and
returns.
Medisystems agreement with Schein, its primary
distributor, will expire in July 2009. Medisystems
agreements with its other primary two distributors are scheduled
to expire in October 2008 and July 2009.
Cost
of Revenues
Cost of revenues consists primarily of direct product costs,
including the material, labor and overhead required to
manufacture Medisystems products and the cost of freight to
Medisystems distributors warehouses. The cost of
Medisystems products depends on several factors, including
the efficiency of manufacturing operations; the costs
established by its third-party manufacturer; the cost of raw
materials from third-party suppliers; and the variability of
freight costs. Medisystems uses freight companies and common
carriers to deliver its products. Medisystems does not own its
own delivery service.
121
Operating
Expenses
Selling and Marketing. Selling expenses
consist primarily of salary and benefits for sales and customer
support personnel, travel, promotional materials, rent and other
expenses associated with providing clinical training to its
customers.
Research and Development. Research and
development expenses consist primarily of salary and benefits
for research and development personnel, supplies, materials and
expenses associated with product design and development.
Distribution. Distribution expenses include
the cost of warehousing and coordinating delivery of products to
customers, including warehouse rental expense and logistics and
document control employees expense.
General and Administrative. General and
administrative expenses consist primarily of salary and benefits
for Medisystems executive management team and its
non-manufacturing personnel. The latter includes, finance and
accounting, logistics and operations support, corporate
engineering staff, regulatory, and information technology and
administrative personnel. Medisystems also incurs fees from
outside legal counsel, fees for annual audits and tax services,
and consulting service fees for third-party marketing and
regulatory services. The general expenses to operate the
business include rent, utilities, non-manufacturing
depreciation, insurance and miscellaneous office supply and
facility repair expenses.
Royalty Expense (to Affiliate). Effective
June 1, 2007, MDS terminated its royalty sublicense
agreement it had with MTC, and MTC terminated its license
agreement with DSU Medical. Effective June 1, 2007, DSU
Medical and MDS entered into a royalty-free, irrevocable license
agreement for consideration of $2.7 million. From 2003
through 2006, royalty expenses had remained constant at
$4.35 million a year as reflected in the historical
financials.
The following discussion for the periods indicated have been
derived from the combined statement of operations of the
Medisystems Group included elsewhere in this proxy statement.
You should not draw any conclusions about future results of
operations for any period based on these historical results.
Comparison
of Six Months Ended June 30, 2006 and June 30,
2007
Revenues Revenues increased by 4.8% to
$32.0 million for the six months ended June 30, 2007
from $30.6 million for the six months ended June 30,
2006. The increase in revenues was attributable primarily to
increased sales to NxStage, increased sales of AVF needles and
Medics, offset by decreased sales to Baxter with the expiration
of the supply contract.
Cost of Revenues Cost of revenues
increased by 0.7% to $23.3 million for the six months ended
June 30, 2007 from $23.1 million for the six months
ended June 30, 2006. The increase in cost of revenues was
entirely attributable to our increased sales volume.
Operating Expenses Operating expenses
decreased by 5.3% to $6.7 million for the six months ended
June 30, 2007 from $7.1 million for the six months
ended June 30, 2006. The overall decrease was due to lower
employee and related costs from fewer corporate, sales and
marketing, and distribution employees, lower research and
development costs for prototypes and machine repair and
maintenance, and lower legal and professional services fees
principally due to the settlement of patent litigation. These
decreases were offset somewhat by a one time increase in royalty
expense with the payment of $2.7 million in paid-up
royalties as compared to $2.2 million in the same period for
2006.
Comparison
of Years Ended December 31, 2006 and 2005
Revenues Revenues increased by 8.1% to
$62.6 million for the year ended December 31, 2006
from $57.9 million for the year ended December 31,
2005. The increase in revenues was attributable to increased
122
sales to NxStage of $3.6 million and increased needles
product sales of $2.7 million. This was partially offset by
a slight decline in bloodlines sales.
Cost of Revenues Cost of revenues
increased by 8.0% to $47.8 million for the year ended
December 31, 2006 from $44.2 million for the year
ended December 31, 2005. The increase in cost of revenues
was entirely attributable to our increased sales volume.
Operating Expenses Operating expenses
increased by 0.9% to $14.6 million for the year ended
December 31, 2006 from $14.4 million for the year
ended December 31, 2005. There was no significant
variability in operating expenses during this period of time
either in total dollars or as a percentage of revenues.
Comparison
of Years Ended December 31, 2005 and 2004
Revenues Revenues decreased by 7.9% to
$57.9 million for the year ended December 31, 2006
from $62.8 million for the year ended December 31,
2005. The decrease in revenues was primarily attributable to
$3.5 million lower sales for bloodlines and the
discontinuation of the OEM relationship with Fresenius resulting
in a decrease of $4.0 million of revenue. The decrease was
somewhat offset by an increase in revenues from the needles
segment of $1.7 million and an increase in revenues from
NxStage of $0.9 million.
Cost of Revenues Cost of revenues
decreased by 5.2% to $44.2 million for the year ended
December 31, 2005 from $46.7 million for the year
ended December 31, 2004. The decrease in cost of revenues
was primarily due to the decreased sales volume. This decrease
was partially offset by production variances at the Mexico
facility.
Operating Expenses Operating expenses
decreased by 14.0% to $14.4 million for the year ended
December 31, 2005 from $16.8 million for the year
ended December 31, 2004. This decrease was attributable to
a decrease of $3.2 million in legal expenses due to the
conclusion of patent litigation offset slightly by increased
employee costs.
Liquidity
and Capital Resources
As of June 30, 2007, Medisystems accumulated retained
earnings was $2.9 million and cash and cash equivalents
totaled approximately $941,000. Medisystems has financed its
operations primarily through cash flow generated by its
operating activities.
In January 2003, the Medisystems Group secured a
$10 million credit commitment from KeyBank National
Association, or the Bank, that expired January 31, 2006.
The commitment consisted of an $8.5 million revolving line
of credit and a $1.5 million letter of credit facility.
Through amendments in December 2003 and August 2004, the Bank
reduced its combined credit commitment to the Medisystems Group
to $5 million, consisting of a $3.5 million revolving
line of credit and a $1.5 million demand line of credit.
The agreement was renewed in January 2006 and will expire
January 2009. The interest on outstanding borrowings is equal to
a Prime-Based Rate (minus 0.75%) or a LIBOR (London Inter-Bank
Offered Rate) Based Rate (plus 1.75%) depending on whether a
LIBOR Rate Election has been made in accordance with provisions
of the respective Promissory Notes supporting the credit loan
agreement. As of June 30, 2007, there were no outstanding
amounts due under the revolving line of credit. The accounts
receivable, inventory, and property of the Medisystems Group,
including the MDS Entities, have been pledged as collateral for
the credit commitment. As of June 30, 2007, KeyBank had
issued on behalf of Medisystems 781,000
($1.1 million) of standby letters of credit expiring
through December 2010. Prime rate at June 30, 2007 and
December 31, 2006 was 8.25%, and the LIBOR range was 5.32%
for one month to 5.4256% for 12 months at June 30, 2007 and
was 5.3256% for one month to 5.32938% for 12 months at December
31, 2006, according to published sources.
At June 30, 2007 and December 31, 2006 MDS Italy has
three separate working capital lines of credit from two Italian
banks totaling 432,000 ($584,000) and 432,000
($570,000), respectively, and bearing interest ranging from
8.85% to 11.625% at June 30, 2007. The lines of credit have
no stated expiration. There were no amounts outstanding under
these lines of credit at either June 30, 2007 or
December 31, 2006. However, MDS Italy has one loan
outstanding as of June 30, 2007 totaling 173,000
($234,000) and as of
123
December 31, 2006 totaling 191,000 ($252,000) which
is due in September 2011. The interest on outstanding borrowings
is equal to EURIBOR (3 months) plus 1.15%, subject to an
interest rate swap agreement at rates greater than 4%. When
EURIBOR (3 months) plus 1.15% exceeds 4%, interest is
calculated on a blended basis, with 50% of the nominal value of
the loan subject to a fixed rate of 4%, and the remaining 50%
subject to the EURIBOR (3 months) plus 1.15%, EURIBOR for
3 months at June 30, 2007 and December 31, 2006
was 4.175% and 3.725%, respectively, according to published
sources. Interest expense reflects the applied blended interest
rate calculation.
We expect that at or prior to the closing of the Stock Purchase,
any surviving obligations against the Medisystems Groups
credit commitments will be resolved by Medisystems and the
credit commitments terminated, except the KeyBank credit
commitment, which will continue to be used to secure guarantees
of VAT refunds made to MDS Italy by an Italian bank. Medisystems
has indicated that it will amend the KeyBank credit commitment
prior to the closing of the Stock Purchase to remove from the
commitment the Medisystems Group companies that are not being
acquired by NxStage.
The following table sets forth the components of the cash flows
for Medisystems for the periods indicated (in thousands):
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
|
|
June 30,
|
|
|
Years Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Net cash provided by operating
activities
|
|
$
|
14
|
|
|
$
|
1,310
|
|
|
$
|
802
|
|
|
$
|
533
|
|
|
$
|
2,557
|
|
Net cash used in investing
activities
|
|
|
(705
|
)
|
|
|
(495
|
)
|
|
|
(1,796
|
)
|
|
|
(852
|
)
|
|
|
(722
|
)
|
Net cash provided by (used in)
financing activities
|
|
|
|
|
|
|
(74
|
)
|
|
|
49
|
|
|
|
74
|
|
|
|
(3,400
|
)
|
Effect of exchange rate changes on
cash
|
|
|
10
|
|
|
|
36
|
|
|
|
66
|
|
|
|
(172
|
)
|
|
|
87
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash flow
|
|
|
(681
|
)
|
|
|
777
|
|
|
|
(879
|
)
|
|
|
(417
|
)
|
|
|
(1,478
|
)
|
Net Cash Provided by Operating Activities. For
each of the periods above, net cash provided by operating
activities was attributable primarily to net profits after
adjustment for non-cash depreciation and amortization charges.
Significant uses of cash from operations include increases in
accounts receivable and increased inventory requirements, offset
by increases in accounts payable and accrued expenses.
Net Cash Used in Investing Activities. For
each of the periods above, net cash used in investing activities
reflected purchases of property and equipment, primarily for
manufacturing operations, capital improvements to
Medisystems facilities, information technology and
research and development.
Net Cash Used In Financing Activities. For the
six months ended June 30, 2007, MDS declared, but did not
pay, dividends to its stockholder Mr. Utterberg of $330,000, as
stipulated by the terms of the stock purchase agreement. For the
year ended December 31, 2006, net cash from financing
activities included a net capital contribution by the sole
shareholder of $123,000 to LMS and ICS and payment by MDS Italy
of $74,000 to resolve a bank overdraft made in the period ending
December 31, 2005. In the period ending December 31,
2004, net cash from financing activities included
$3.4 million in dividends paid to the sole shareholder and
a $74,000 bank overdraft made by MDS Italy.
The following table summarizes our contractual commitments as of
June 30, 2007 and the effect those commitments are expected
to have on liquidity and cash flow in future periods. The table
does not include purchases that are made in the ordinary course
of business.
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|
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|
|
|
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|
|
Payments Due by Period as of June 30, 2007 (in
thousands)
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|
Total
|
|
|
2007
|
|
|
2008 to 2010
|
|
|
2011 to 2013
|
|
|
Thereafter
|
|
|
Notes payable
|
|
|
260
|
|
|
|
31
|
|
|
|
183
|
|
|
|
46
|
|
|
|
|
|
Royalty payable
|
|
|
4,494
|
|
|
|
4,494
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases
|
|
|
3,943
|
|
|
|
648
|
|
|
|
2,544
|
|
|
|
751
|
|
|
|
|
|
Purchase obligations
|
|
|
519
|
|
|
|
519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash obligations
|
|
|
9,216
|
|
|
|
5,692
|
|
|
|
2,727
|
|
|
|
797
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
|
|
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|
124
Summary
of Critical Accounting Policies and Estimates
The discussion and analysis of the financial condition and
results of operations are based upon the combined financial
statements of the Medisystems Group, which have been prepared in
accordance with GAAP. The preparation of these combined
financial statements requires the Medisystems Group to make
significant estimates and judgments that affect the reported
amounts of assets, liabilities, revenues and expenses. These
items are regularly monitored and analyzed by management for
changes in facts and circumstances, and material changes in
these estimates could occur in the future. Changes in estimates
are recorded in the period in which they become known. The
Medisystems Group bases their estimates on historical experience
and various other assumptions that they believe to be reasonable
under the circumstances. Actual results may differ substantially
from their estimates.
A summary of those accounting policies and estimates that the
Medisystems Group management believes are most critical to fully
understanding and evaluating our financial results is set forth
below.
Inventories Inventories are stated at
the lower of cost
(first-in,
first-out basis) or market.
Property and Equipment Property and
equipment are stated at cost, less accumulated depreciation.
Depreciation is calculated primarily on a straight-line basis
over the estimated useful lives of the related assets, ranging
from 3 to 15 years.
Long-Lived Assets The Medisystems
Groups management periodically reevaluates long-lived
assets consisting primarily of property, equipment, and
leasehold improvements to determine whether there has been any
impairment of the value of these assets and the appropriateness
of their estimated remaining lives. No such impairment was
recognized as of June 30, 2007 and December 31, 2006
and 2005, respectively.
Revenue Recognition The Medisystems
Group recognizes revenue when persuasive evidence of an
arrangement exists, delivery has occurred, the sales price is
fixed and determinable, and collectibility is reasonably
assured. The Medisystems Group sells its goods based on terms
which define transfer title and risk of loss at a specific
location, typically FOB destination. In addition, the
Medisystems Group periodically evaluates whether an allowance
for sales returns is necessary. Historically, the level of
returns has been insignificant.
Foreign Currency Translation Assets
and liabilities denominated in foreign currencies are translated
to U.S. dollars at the exchange rate on the balance sheet
date. Revenues, costs and expenses are translated at average
rates of exchange prevailing during the year. The translation
adjustment resulting from the translation of foreign currencies
of combining companies is presented either separately in
stockholders equity if the combining companys
functional currency is its local currency, or as a remeasurement
gain or loss in the statement of income, comprehensive income
and retained earnings (deficit) if the combining companys
functional currency is the U.S. dollar.
Foreign Income Taxes The Medisystems
Group accounts for foreign income taxes under the asset and
liability method whereby deferred income taxes are recorded for
the temporary differences between the amounts of assets and
liabilities for financial reporting purposes and amounts as
measured for tax purposes.
Related-Party
Transactions
The underlying technology included in the products and
components produced by the Medisystems Group are covered by
patents developed and owned by DSU Medical. Through a series of
license and sublicense agreements executed in 1998, DSU Medical
granted MTC a nonexclusive license to this technology, which in
turn granted a nonexclusive sublicense to the technology to
Medisystems. During April 2001, both the license and sublicense
agreements were amended to grant exclusive right and license to
use certain subject patents referenced in the original license
and sublicense agreements. These amendments also increased the
annual royalty payment, payable quarterly, in advance, from
Medisystems under the sublicense agreement from
$5.7 million to $5.8 million. The license agreement,
also dated October 1, 1998, requires MTC to pay a royalty
to DSU Medical in an amount ranging from 75% to 100% of any
sublicense royalties received by MTC.
125
For the period January 1, 2007 through
May 31, 2007, at the discretion of the sole common
stockholder, Mr. Utterberg, and in contemplation of a
renegotiation of existing agreements, DSU Medical did not charge
royalty payments to MTC and MTC, in turn, did not charge royalty
to MDS.
Effective June 1, 2007, DSU Medical and MDS terminated the
royalty sublicense agreement to MDS for consideration of
$2.7 million to be paid to DSU Medical. A new royalty-free
license agreement between DSU Medical and MDS was entered into
effective June 1, 2007. As of and for the six months ended
June 30, 2007, under these license and royalty agreements,
MDS incurred royalty expense of $2.7 million in
consideration of termination of the royalty-free licence
agreement and owed $4.5 million to DSU Medical.
As of and for the period ended December 31, 2006, under
these license and royalty agreements, MDS incurred royalty
expense of $5.8 million and owed $5.8 million payable
to MTC and MTC incurred royalty expense of $4.4 million and
owed $11.2 million payable to DSU Medical.
As of and for the period ending December 31, 2005, under
these license and royalty agreements, MDS incurred royalty
expense of $5,800,000 and owed $12.7 million payable to MTC
and MTC incurred royalty expense of $4.4 million and owed
$8.8 million payable to DSU Medical.
As of and for the period ended December 31, 2004, under these
licence and royalty agreements, MDS incurred royalty expense of
$5,800,000 and owed $11,150,000 payable to MTC and MTC incurred
royalty expense of $4,350,000 and owed $8,700,000 payable to DSU
Medical.
All royalty amounts paid and received between MDS and MTC under
their sublicense agreement have been eliminated in the
accompanying financial statements.
The Medisystems Group has an amount payable to DSU Medical of
$45,000 at June 30, 2007 and $121,000 at December 31,
2006 for reimbursement of travel expenses paid on behalf of MDS
during 2006. The Medisystems Group has an amount payable to
Mr. Utterberg of $0 and $55,000 at June 30, 2007 and
December 31, 2006 and an amount receivable from
Mr. Utterberg at $83,000 at December 31, 2005.
The Medisystems Group made sales of $3,682,000 and $1,260,000
for the six months ended June 30, 2007 and 2006, respectively
and $4,560,000, $1,042,000 and $277,000 for the years ended
December 31, 2006, 2005 and 2004, respectively to NxStage, which
is partly owned by Mr. Utterberg, the sole shareholder of the
Medisystems Group. The accounts receivable balance from NxStage
as of June 30, 2007 was $906,000 and as of December 31, 2006 and
2005 was $1,056,000 and $256,000, respectively.
Off-Balance
Sheet Arrangements
Except for the interest rate swap described above under the
heading Liquidity and Capital Resources
the Medisystems Group has not engaged in any off-balance sheet
activities.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MEDISYSTEMS MARKET
RISK
Under the Medisystems Groups current credit facilities in
the United States, the Medisystems Group may borrow at the
lenders prime rate between minus 75 basis points or a
LIBOR Based Rate plus 175 basis points. Prime rate at
June 30, 2007 was 8.25% and the LIBOR range was 5.32% for
1 month to 5.4256% for 12 months at June 30,
2007, according to published sources. As of June 30, 2007,
there were no outstanding amounts due under the revolving lines
of credit.
At June 30, 2007, MDS Italy had three separate working
capital lines of credit from two Italian banks totaling
432,000 ($584,000), bearing interest ranging from 8.85% to
11.125% at June 30, 2007. The lines of credit have no
stated expiration. There were no amounts outstanding under these
lines of credit as of June 30, 2007.
MDS Italy had one loan outstanding as of June 30, 2007
totaling 173,000 ($234,000) which expires in September,
2011. The interest on outstanding borrowings is equal to EURIBOR
for 3 months (plus 1.15%)
126
subject to an interest rate swap agreement at rates greater than
4%. When EURIBOR (3 months) plus 1.15% exceeds 4%, interest
is calculated on a blended basis, with 50% of the nominal value
of the loan subject to a fixed rate of 4%, and the remaining
50% subject to the EURIBOR (3 months) plus 1.15% rate.
EURIBOR for 3 months at June 30, 2007 was 4.175%
according to published sources.
As of June 30, 2007, management estimates that a
100 basis point change in these interest rates would have
an insignificant impact on net income due to the level of debt
outstanding at June 30, 2007.
Foreign
Currency Exposure
The Medisystems Group operates manufacturing facilities in
Modena, Italy and Tijuana, Mexico and, as a result, purchases
materials for these facilities and pays its employees in Euros
and Mexican Pesos, respectively. In addition, it purchases
products for resale in the United States from certain suppliers
and has agreed to pay them in currencies other than the
U.S. dollar, most significantly, in the case of Kawasumi,
in the Thai Baht. As a result, its expenses and cash flows are
subject to fluctuations due to changes in foreign exchange
rates. In the period the U.S. dollar declines in value as
compared to the foreign currencies in which the Medisystems
Group incurs expenses, its foreign currency based expenses
increase when translated into U.S. dollars. Although it is
possible to do so, the Medisystems Group does not hedge its
foreign currency since the exposure has not been material to its
historical operating results. A 10% movement in the Euro and
Peso would have had an overall impact to the financial
statements of approximately $9,000 and $24,000 for the periods
ending June 30, 2007 and December 31, 2006,
respectively.
127
MANAGEMENT
FOLLOWING THE STOCK PURCHASE
Resignation
of the MDS Entities Current Officers and
Directors
Immediately prior to the closing of the Stock Purchase, each
officer and director of the MDS Entities shall resign. Upon the
closing of the Stock Purchase, we, as the controlling
stockholder of the MDS Entities, will appoint new directors and
officers.
Executive
Officers and Directors of NxStage Following the Stock
Purchase
Following the Stock Purchase, the management and the board of
directors of NxStage are expected to be as follows, with the
names and ages listed as of July 31, 2007.
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|
|
|
Name
|
|
Age
|
|
|
Position
|
|
|
Jeffrey H. Burbank
|
|
|
45
|
|
|
|
President, Chief Executive Officer and Director
|
|
Robert S. Brown
|
|
|
48
|
|
|
|
Senior Vice President and Chief Financial Officer
|
|
Winifred L. Swan
|
|
|
43
|
|
|
|
Senior Vice President, General Counsel and Secretary
|
|
Joseph E. Turk, Jr.
|
|
|
39
|
|
|
|
Senior Vice President, Commercial Operations
|
|
Michael J. Webb
|
|
|
41
|
|
|
|
Senior Vice President, Quality, Regulatory and Clinical Affairs
|
|
Philippe O. Chambon
|
|
|
49
|
|
|
|
Chairman of the Board of Directors
|
|
Daniel A. Giannini
|
|
|
57
|
|
|
|
Director
|
|
Craig W. Moore
|
|
|
62
|
|
|
|
Director
|
|
Reid S. Perper
|
|
|
48
|
|
|
|
Director
|
|
Peter P. Phildius
|
|
|
77
|
|
|
|
Director
|
|
David S. Utterberg
|
|
|
61
|
|
|
|
Director
|
|
NxStage
Executive Officers
Jeffrey H. Burbank has been our President and Chief
Executive Officer and a director of NxStage since 1999. Prior to
joining NxStage, Mr. Burbank was a founder and the Chief
Executive Officer of Vasca, Inc., a medical device company that
developed and marketed a blood access device for dialysis
patients. Mr. Burbank currently serves on the board of
directors of the National Kidney Foundation. He holds a B.S.
from Lehigh University.
Robert S. Brown has been our Senior Vice President, Chief
Financial Officer and Treasurer since November 2006. Prior to
joining NxStage, Mr. Brown held several leadership
positions in Boston Scientific Corporations financial
group including Vice President, Corporate Analysis &
Control from 2005 until he joined us in 2006, where he and his
team were responsible for Boston Scientifics financial,
compliance and operational audits and reported directly to the
Audit Committee of the Board of Directors. Mr. Brown also
served as Vice President, International from 1999 through 2004,
where he was responsible for the financial functions of Boston
Scientifics international division in over forty
countries. Previous experience also includes financial reporting
and special projects at United Technologies and public
accounting and consulting at Deloitte & Touche. He
holds a B.B.A. degree in Accounting from the University of
Toledo and an M.B.A. from the University of Michigan, and is a
certified public accountant.
Winifred L. Swan has been our Senior Vice President since
January 2005 and our Vice President and General Counsel since
November 2000. From July 1995 to November 2000, Ms. Swan
was Senior Corporate
128
Counsel at Boston Scientific Corporation. She holds a B.A.,
cum laude, in Economics and Public Policy from Duke
University and a J.D., cum laude and Order of the
Coif, from the University of Pennsylvania Law School.
Joseph E. Turk, Jr. has been our Senior Vice
President, Commercial Operations since January 2005 and our Vice
President, Sales and Marketing since May 2000. From August 1998
to May 2000, Mr. Turk was employed at Boston Scientific
Corporation as Director of New Business Development.
Mr. Turk holds an A.B. degree in Economics from Wabash
College and an M.B.A. in Marketing and Finance from Northwestern
Universitys Kellogg School of Management.
Michael J. Webb has been our Senior Vice President
of Quality, Regulatory and Clinical Affairs since August 2007,
Vice President of Disposables Operations from January 2007
through August 2007, Vice President of Quality Assurance and
Regulatory Affairs from July 2002 through January 2007, and our
Vice President of Operations from July 2001 through July 2002.
Prior to joining NxStage, Mr. Webb was Vice President of
Operations for Mosaic Technologies, a developer of gene-based
diagnostic products. Other previous positions include Director
of Operations for TFX Medical and Director of Disposables
Manufacturing and Logistics for Haemonetics Corporation.
Mr. Webb received a B.S. degree in Industrial and
Management Engineering and his M.B.A. in Manufacturing
Management from Rensselaer Polytechnic Institute.
NxStage
Directors
Philippe O. Chambon, M.D., Ph.D. has served
as a director of NxStage since 1998, has been Chairman of our
board of directors since December 2004 and currently serves on
our Compensation and Nominating and Corporate Governance
Committees. Dr. Chambon is a Managing Director and founder
of New Leaf Venture Partners, a spin-off from The Sprout Group.
He joined Sprout in May 1995 and became a General Partner in
January 1997. He invests broadly in healthcare technology
companies. He is currently on the board of Auxilium
Pharmaceuticals and PharSight Corporation, as well as several
private companies. Previously, Dr. Chambon served as
Manager in the Healthcare Practice of The Boston Consulting
Group from May 1993 to April 1995. From September 1987 to April
1993, he was an executive with Sandoz Pharmaceutical, where he
led strategic product development, portfolio management and
pre-marketing activities in his capacity as Executive Director
of New Product Management. Dr. Chambon did graduate
research in molecular immunology at The Pasteur Institute and
earned a MD, Ph.D. from the University of Paris. He also
has an MBA from Columbia University in New York.
Daniel A. Giannini has served as a director of NxStage
since October 2005 and currently serves as chair of our Audit
Committee and a member of our Nominating and Corporate
Governance Committee. Mr. Giannini is currently an
executive advisor at the Advanced Technology Development Center
of the Georgia Institute of Technology. He retired in June 2005,
after a more than
30-year
career, as a Certified Public Accountant with
PricewaterhouseCoopers LLP. During his last five years at
PricewaterhouseCoopers LLP, Mr. Giannini served as an audit
partner and led the firms Atlanta offices
Technology, Information, Communications and Entertainment
practice. Mr. Giannini received a B.S. degree in Business
Administration from LaSalle University.
Craig W. Moore has served as a director of NxStage since
2002 and currently serves as chair of our Compensation Committee
and a member of our Audit Committee. From 1986 to 2001,
Mr. Moore was chairman of the board of directors and chief
executive officer at Everest Healthcare Services Corporation, a
provider of dialysis to patients with renal failure. Since 2001,
Mr. Moore has acted as a consultant to various companies in
the healthcare services industry. From 1986 through 2001,
Mr. Moore was President of Continental Health Care, Ltd.,
an extracorporeal services and supply company and, from 1990
through 2004, he was President of New York Dialysis Management,
a dialysis management business. Mr. Moore serves as a
director on several private company boards.
Reid S. Perper has served as a director of NxStage since
September 2005 and currently serves as a member of our Audit
Committee. Since January 2004, Mr. Perper has been a
Managing Director of Healthcare Investment Partners LLC. From
November 2000 through June 2003, Mr. Perper was a Managing
Director and Co-Head of Europe for CSFB Private Equity. Prior to
joining CSFB, Mr. Perper was a Managing Director of
129
DLJ Merchant Banking Partners. Mr. Perper joined Donaldson,
Lufkin & Jenrette in 1988. Mr. Perper also served
as an investment professional for Caxton Europe Asset Management
Ltd. from July 2001 through July 2005.
Peter P. Phildius has served as a director of NxStage
since 1998 and served as Chairman of our board of directors from
1998 until December 2004 and currently serves as the chair of
our Nominating and Corporate Governance Committee and as a
member of our Compensation Committee. Since 1986,
Mr. Phildius has been the Chairman and Chief Executive
Officer of Avitar, Inc., which develops, manufactures and
markets products for the oral fluid diagnostic and clinical
testing markets, as well as customized polyurethane applications
used in wound dressings. Since 1985, Mr. Phildius has been
a partner in PKS Consulting Services. Mr. Phildius also
previously served as the President and Chief Operating Officer
of National Medical Care, Inc. (now Fresenius Medical Care) and
Vice President and President of the Parenteral, Artificial
Organs and Fenwal Divisions of Baxter Laboratories, the
predecessor of Baxter Healthcare Corp.
David S. Utterberg has served as a director of NxStage
since 1998. Since 1981, Mr. Utterberg has been the Chief
Executive Officer, President and the sole stockholder of MDS,
which supplies the completed disposable cartridges used with our
System One, and since 1996, he has been the President and sole
stockholder of DSU Medical Corporation. MDS is a designer,
manufacturer and supplier of disposable medical devices for the
extracorporeal blood therapy market and DSU Medical
Corporation holds and licenses over 90 U.S. and foreign
patents and other intellectual property in medical technology
focused on extracorporeal therapy devices. Mr. Utterberg
was also a director of Vasca, Inc., a medical device company
that developed and marketed a blood access device for dialysis
patients.
Under applicable NASDAQ rules, a director will only qualify as
an independent director if, in the opinion of our
board of directors, that person does not have a relationship
which would interfere with the exercise of independent judgment
in carrying out the responsibilities of a director. Our board of
directors has determined that Dr. Chambon and
Messrs. Giannini, Perper, Phildius and Moore each do not
have a relationship which would interfere with the exercise of
independent judgment in carrying out the responsibilities of a
director and that each of these directors is an
independent director as defined under
Rule 4200(a)(15) of the NASDAQ Stock Market, Inc.
Marketplace Rules. In determining the independence of the
directors listed above, our board of directors considered the
transaction discussed in NxStage Certain Relationships and
Related Transactions.
130
UNAUDITED
PRO FORMA COMBINED FINANCIAL STATEMENTS
The unaudited pro forma combined financial statements combine
the historical consolidated financial information of NxStage
with historical combined financial information of certain
Medisystems Group companies.
The historical financial information has been adjusted to give
effect to pro forma events that are (1) directly
attributable to the Stock Purchase and (2) factually
supportable. With respect to the statements of operations, the
pro forma adjustments give effect to events that are expected to
have a continuing impact on the combined results. You should
read this information in conjunction with the:
|
|
|
|
|
Accompanying notes to the unaudited pro forma combined financial
statements contained in this proxy statement;
|
|
|
|
Separate historical audited combined financial statements of the
Medisystems Group as of December 31, 2006 and 2005 and for
the three years ended December 31, 2006, and the
Medisystems Group unaudited combined financial statements as of
and for the six months ended June 30, 2007 and 2006
included in this proxy statement; and
|
|
|
|
Separate historical audited consolidated financial statements of
NxStage as of and for the years ended December 31, 2006 and
2005 and for the three years ended December 31, 2006
included in this proxy statement, and NxStages unaudited
condensed consolidated financial statements as of and for the
six months ended June 30, 2007 and 2006 included in this
proxy statement.
|
The pro forma financial statements are presented for
informational purposes only. The pro forma information is not
necessarily indicative of what the financial position or results
of operations actually would have been had the Stock Purchase
been completed at the dates indicated. In addition, the
unaudited pro forma combined financial information does not
purport to project the future financial position or operating
results of the combined company after completion of the Stock
Purchase.
The pro forma financial statements were prepared using the
purchase method of accounting. Accordingly, NxStages cost
to acquire certain Medisystems Group companies, which are
referred to as the MDS Entities, will be allocated to the assets
acquired and liabilities assumed based on their fair values as
of the date of completion of the Stock Purchase. This allocation
is dependent upon certain valuations and other studies that have
not progressed to a stage where sufficient information is
available to make a definitive allocation. The purchase price
allocation adjustments and related amortization reflected in the
following unaudited pro forma combined financial statements are
preliminary and have been made solely for the purpose of
preparing these statements.
The pro forma adjustments are based upon available information
and certain assumptions that NxStage believes are reasonable
under the circumstances. A final determination of the fair value
of the assets acquired and liabilities assumed, which cannot be
made prior to the completion of the acquisition, may differ
materially from the preliminary estimates. This final valuation
will be based on the actual tangible and intangible assets and
liabilities of the MDS Entities that are acquired as of the date
of completion of the Stock Purchase. The final valuation may
change the purchase price allocation, which could affect the
fair value assigned to the assets acquired and liabilities
assumed and could result in a change to the unaudited pro forma
combined financial statements.
The pro forma financial statements reflect the elimination of
certain corporations included in Medisystems Group combined
financial statements that will not be acquired by NxStage, which
are referred to as the Excluded Entities in the unaudited pro
forma combined financial statements.
The unaudited pro forma combined financial statements do not
reflect the realization of potential cost savings or any
potential restructuring costs. Certain cost savings may result
from the Stock Purchase. However, there can be no assurance that
these cost savings will be achieved. Cost savings, if achieved,
could result from, among other things, the reduction of overhead
expenses, changes in corporate infrastructure, the elimination
of duplicative facilities and the leveraging of consolidated
annual external purchases.
131
The unaudited pro forma combined financial statements do not
include accruals in excess of amounts recorded by Medisystems
Group companies for any pre-Stock Purchase contingencies.
Upon the closing of the Stock Purchase, Mr. Utterberg is
expected to receive 6,500,000 shares of NxStage common
stock with an estimated value of $81.3 million (based on
the average trading price of our shares of common stock on the
NASDAQ Global Market for five days before and five days
following June 4, 2007, the date the stock purchase
agreement was announced), subject to a post-closing working
capital adjustment that may increase or decrease the number of
shares issued, in exchange for all of his equity interests in
the MDS Entities. The stock purchase agreement contains certain
indemnification provisions that may result in additional shares
of NxStage common stock being issued to Mr. Utterberg. See
Stock Purchase Stock Purchase
Consideration Working Capital Adjustment Following
Closing section for additional information regarding
potential adjustments to the purchase price.
132
UNAUDITED
PRO FORMA COMBINED BALANCE SHEET
JUNE 30, 2007
(In thousands)
The following unaudited pro forma combined balance sheet gives
effect to the Stock Purchase as if it was completed on
June 30, 2007 and combines the MDS Entities
June 30, 2007 unaudited combined balance sheet with
NxStages June 30, 2007 unaudited consolidated balance
sheet. The MDS Entities Historical column reflects the
elimination of certain assets and liabilities included in the
Medisystems Group combined balance sheet that will not be
acquired by NxStage.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MDS
|
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
Entities
|
|
|
Acquisition
|
|
|
|
|
|
|
NxStage
|
|
|
Historical
|
|
|
Adjustments
|
|
|
Pro Forma
|
|
|
|
Historical
|
|
|
(Note 2)
|
|
|
(Note 1)
|
|
|
Combined
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
42,046
|
|
|
$
|
802
|
|
|
$
|
(3,259
|
)(a)(b)
|
|
$
|
39,589
|
|
Short-term investments
|
|
|
10,921
|
|
|
|
|
|
|
|
|
|
|
|
10,921
|
|
Accounts receivable, net
|
|
|
6,010
|
|
|
|
4,837
|
|
|
|
(906
|
)(b)
|
|
|
9,941
|
|
Inventory
|
|
|
15,144
|
|
|
|
8,668
|
|
|
|
795
|
(c)
|
|
|
24,607
|
|
Prepaid and other current assets
|
|
|
479
|
|
|
|
1,618
|
|
|
|
|
|
|
|
2,097
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
74,600
|
|
|
|
15,925
|
|
|
|
(3,370
|
)
|
|
|
87,155
|
|
Property and equipment, net
|
|
|
4,018
|
|
|
|
3,501
|
|
|
|
|
|
|
|
7,519
|
|
Field equipment, net
|
|
|
23,685
|
|
|
|
|
|
|
|
|
|
|
|
23,685
|
|
Other assets
|
|
|
10,866
|
|
|
|
135
|
|
|
|
|
|
|
|
11,001
|
|
Intangible assets
|
|
|
|
|
|
|
|
|
|
|
32,360
|
(d)
|
|
|
32,360
|
|
Goodwill
|
|
|
|
|
|
|
|
|
|
|
48,973
|
(e)
|
|
|
48,973
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
113,169
|
|
|
$
|
19,561
|
|
|
$
|
77,963
|
|
|
$
|
210,693
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY
|
Accounts payable
|
|
$
|
9,566
|
|
|
$
|
9,160
|
|
|
$
|
(665
|
)(b)
|
|
$
|
18,061
|
|
Accrued expenses
|
|
|
5,372
|
|
|
|
7,006
|
|
|
|
|
|
|
|
12,378
|
|
Current portion of long-term debt
|
|
|
2,800
|
|
|
|
|
|
|
|
|
|
|
|
2,800
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
17,738
|
|
|
|
16,166
|
|
|
|
(665
|
)
|
|
|
33,239
|
|
Deferred rent obligation
|
|
|
618
|
|
|
|
34
|
|
|
|
|
|
|
|
652
|
|
Deferred revenue
|
|
|
13,324
|
|
|
|
|
|
|
|
|
|
|
|
13,324
|
|
Long-term obligations
|
|
|
3,216
|
|
|
|
739
|
|
|
|
|
|
|
|
3,955
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
34,896
|
|
|
|
16,939
|
|
|
|
(665
|
)
|
|
|
51,170
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Undesignated preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
30
|
|
|
|
287
|
|
|
|
(280
|
)(f)
|
|
|
37
|
|
Additional paid-in capital
|
|
|
226,544
|
|
|
|
|
|
|
|
81,243
|
(f)
|
|
|
307,787
|
|
Accumulated (deficit) earnings
|
|
|
(148,516
|
)
|
|
|
2,367
|
|
|
|
(2,367
|
)(f)
|
|
|
(148,516
|
)
|
Accumulated other comprehensive
income (loss)
|
|
|
215
|
|
|
|
(32
|
)
|
|
|
32
|
(f)
|
|
|
215
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
78,273
|
|
|
|
2,622
|
|
|
|
78,628
|
|
|
|
159,523
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity
|
|
$
|
113,169
|
|
|
$
|
19,561
|
|
|
$
|
77,963
|
|
|
$
|
210,693
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited
pro forma
combined financial statements.
133
UNAUDITED
PRO FORMA COMBINED STATEMENT OF OPERATIONS
FOR THE SIX MONTHS ENDED
JUNE 30, 2007
(In thousands, except share and per share amounts)
The following unaudited pro forma combined statement of
operations gives effect to the Stock Purchase as if it was
completed on January 1, 2006 and combines the MDS
Entities unaudited statement of operations for the six
months ended June 30, 2007 with NxStages unaudited
statement of operations for the six months ended June 30,
2007. The MDS Entities Historical column reflects the
elimination of the results of operations of the Excluded
Entities, which are included in the Medisystems Group combined
unaudited statement of operations for the six months ended
June 30, 2007 but will not be acquired by NxStage.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MDS
|
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
Entities
|
|
|
Acquisition
|
|
|
|
|
|
|
NxStage
|
|
|
Historical
|
|
|
Adjustments
|
|
|
Pro Forma
|
|
|
|
Historical
|
|
|
(Note 4)
|
|
|
(Note 1)
|
|
|
Combined
|
|
|
Revenues
|
|
$
|
18,405
|
|
|
$
|
32,028
|
|
|
$
|
(3,689
|
)(g)
|
|
$
|
46,744
|
|
Cost of revenues
|
|
|
21,428
|
|
|
|
23,275
|
|
|
|
(3,510
|
)(g)
|
|
|
41,193
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross (deficit) profit
|
|
|
(3,023
|
)
|
|
|
8,753
|
|
|
|
(179
|
)
|
|
|
5,551
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
9,852
|
|
|
|
922
|
|
|
|
|
|
|
|
10,774
|
|
Research and development
|
|
|
2,854
|
|
|
|
508
|
|
|
|
|
|
|
|
3,362
|
|
Distribution
|
|
|
5,341
|
|
|
|
491
|
|
|
|
|
|
|
|
5,832
|
|
General and administrative
|
|
|
5,193
|
|
|
|
1,696
|
|
|
|
1,447
|
(h)
|
|
|
8,336
|
|
Royalty to affiliate
|
|
|
|
|
|
|
2,661
|
|
|
|
(2,661
|
)(i)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
23,240
|
|
|
|
6,278
|
|
|
|
(1,214
|
)
|
|
|
28,304
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from operations
|
|
|
(26,263
|
)
|
|
|
2,475
|
|
|
|
1,035
|
|
|
|
(22,753
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income
|
|
|
1,736
|
|
|
|
149
|
|
|
|
|
|
|
|
1,885
|
|
Interest and other expense
|
|
|
(348
|
)
|
|
|
(109
|
)
|
|
|
|
|
|
|
(457
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
1,388
|
|
|
|
40
|
|
|
|
|
|
|
|
1,428
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before foreign
income taxes
|
|
|
(24,875
|
)
|
|
|
2,515
|
|
|
|
1,035
|
|
|
|
(21,325
|
)
|
Provision for foreign income taxes
|
|
|
|
|
|
|
126
|
|
|
|
|
|
|
|
126
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(24,875
|
)
|
|
$
|
2,389
|
|
|
$
|
1,035
|
|
|
$
|
(21,451
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.84
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(0.60
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of weighted average
shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
29,488,097
|
|
|
|
|
|
|
|
6,500,000
|
(j)
|
|
|
35,988,097
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited
pro forma
combined financial statements.
134
UNAUDITED
PRO FORMA COMBINED STATEMENT OF OPERATIONS
FOR THE YEAR ENDED
DECEMBER 31, 2006
(In thousands, except share and per share amounts)
The following unaudited pro forma combined statement of
operations gives effect to the Stock Purchase as if it was
completed on January 1, 2006 and combines the MDS
Entities statement of operations for the year ended
December 31, 2006 with NxStages consolidated
statement of operations for the year ended December 31,
2006. The MDS Entities Historical column reflects the
elimination of the results of operations of the Excluded
Entities, which are included in the Medisystems Group combined
statement of operations for the year ended December 31,
2006 but will not be acquired by NxStage.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MDS
|
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
Entities
|
|
|
Acquisition
|
|
|
|
|
|
|
NxStage
|
|
|
Historical
|
|
|
Adjustments
|
|
|
Pro Forma
|
|
|
|
Historical
|
|
|
(Note 6)
|
|
|
(Note 1)
|
|
|
Combined
|
|
|
Revenues
|
|
$
|
20,812
|
|
|
$
|
62,575
|
|
|
$
|
(4,501
|
)(g)
|
|
$
|
78,886
|
|
Cost of revenues
|
|
|
26,121
|
|
|
|
47,782
|
|
|
|
(3,986
|
)(g)
|
|
|
69,917
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross (deficit) profit
|
|
|
(5,309
|
)
|
|
|
14,793
|
|
|
|
(515
|
)
|
|
|
8,969
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
14,356
|
|
|
|
2,280
|
|
|
|
|
|
|
|
16,636
|
|
Research and development
|
|
|
6,431
|
|
|
|
1,461
|
|
|
|
|
|
|
|
7,892
|
|
Distribution
|
|
|
7,093
|
|
|
|
1,238
|
|
|
|
|
|
|
|
8,331
|
|
General and administrative
|
|
|
8,703
|
|
|
|
3,762
|
|
|
|
2,894
|
(h)
|
|
|
15,359
|
|
Royalty to affiliate
|
|
|
|
|
|
|
5,800
|
|
|
|
(5,800
|
)(i)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
36,583
|
|
|
|
14,541
|
|
|
|
(2,906
|
)
|
|
|
48,218
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from operations
|
|
|
(41,892
|
)
|
|
|
252
|
|
|
|
2,391
|
|
|
|
(39,249
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income
|
|
|
3,236
|
|
|
|
282
|
|
|
|
|
|
|
|
3,518
|
|
Interest and other expense
|
|
|
(973
|
)
|
|
|
(251
|
)
|
|
|
|
|
|
|
(1,224
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
2,263
|
|
|
|
31
|
|
|
|
|
|
|
|
2,294
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before foreign
income taxes
|
|
|
(39,629
|
)
|
|
|
283
|
|
|
|
2,391
|
|
|
|
(36,955
|
)
|
Provision for foreign income taxes
|
|
|
|
|
|
|
199
|
|
|
|
|
|
|
|
199
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(39,629
|
)
|
|
$
|
84
|
|
|
$
|
2,391
|
|
|
$
|
(37,154
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(1.60
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(1.19
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of weighted average shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
24,817,020
|
|
|
|
|
|
|
|
6,500,000
|
(j)
|
|
|
31,317,020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited
pro forma
combined financial statements.
135
NOTES TO
UNAUDITED PRO FORMA COMBINED FINANCIAL STATEMENTS
JUNE 30, 2007
Description
of the Medisystems Acquisition and Basis of
Presentation
Medisystems
Acquisition
Under the terms of the Stock Purchase, the equity interests of
certain Medisystems Group companies held by Mr. Utterberg
will be exchanged for 6,500,000 shares of NxStage common
stock. The Stock Purchase is subject to customary closing
conditions, including the approval of NxStage stockholders and
receipt of certain regulatory approvals. Subject to these
conditions, NxStage currently expects the Stock Purchase will
close in the fourth quarter of 2007.
NxStage will account for the Stock Purchase as a purchase under
GAAP. Under the purchase method of accounting, the assets and
liabilities of the MDS Entities will be recorded as of the
closing date of the Stock Purchase at their respective fair
values and consolidated with those of NxStage. The results of
operations of the MDS Entities will be consolidated with those
of NxStage beginning on the closing date of the Stock Purchase.
NxStage expects the Stock Purchase to be treated as a
non-taxable transaction within the meaning of Section 368
of the Internal Revenue Code of 1986, as amended; therefore, the
amortization or write-off of intangible assets, including
goodwill, will not be tax deductible.
Basis of
Presentation
The Medisystems Group is composed of various domestic and
international corporations related through common ownership and
interdependency of their operations. The Medisystems Group is
involved in the design, manufacture, assembly, import, export
and distribution of disposable medical devices primarily for use
in dialysis and related blood therapies. Certain members of the
Medisystems Group represent contract manufacturers that sell
their products exclusively to the other members of the
Medisystems Group.
The commonality of ownership within the Medisystems Group is
through a single stockholder, Mr. Utterberg, who directly
or indirectly owns and controls all the outstanding equity of
the Medisystems Group.
The following entities will be acquired by NxStage. These
entities are included in the historical combined financial
statements of the Medisystems Group and are collectively
referred to herein as the MDS Entities:
Medisystems Corporation, or MDS MDS designs, imports
and distributes the Medisystems Groups products and is
principally located in Seattle, Washington. MDS owns equipment
located in Italy and Mexico that is utilized in the
manufacturing and assembly operations of other members of the
Medisystems Group;
Medimexico, S. de R.L. de C.V., or MDM MDM provides
manufacturing and assembly services of components and finished
products to MDS under a Maquiladora contract and is located in
Tijuana, Baja California, Mexico. All products produced by MDM
are sold under a contract manufacturing agreement to MDS for
inclusion in its final products;
Medisystems Europe S.p.A., or MDE Formerly known as
Amtech, S.r.L., MDE provides manufacturing and assembly services
of components to MDS. MDEs operations are located in
Sorbara, Modena, Italy, and utilize certain manufacturing and
assembly equipment owned by MDS. All of MDEs production is
sold under a contract manufacturing agreement to MDS for
inclusion in its final products;
Medisystems Services Corporation, or MSC MSC,
located in Las Vegas Nevada, provides contract employment
services exclusively to Medisystems Group companies.
136
NOTES TO UNAUDITED PRO FORMA COMBINED FINANCIAL
STATEMENTS (Continued)
The following entities will not be acquired by NxStage. These
entities are included in the historical combined financial
statements of the Medisystems Group and are collectively
referred to herein as the Excluded Entities:
Medisystems Research Group, or MRC MRC conducts
research and development activities and is located outside of
Chicago, Illinois.
Medisystems Technology Corporation, or MTC MTC,
located in Las Vegas, Nevada, is responsible for securing
intellectual property licenses for the components used in the
Medisystems Groups products. Effective June 1, 2007,
MTC was merged into DSU Medical and included in
DSU Medicals separately reported financial
statements. The assets, liabilities and equity of MTC and DSU
Medical are not among the companies being acquired by NxStage in
the Stock Purchase. Effective June 1, 2007, the MDS
Entities have a royalty-free, irrevocable license to use the
intellectual property owned by DSU Medical;
Life Stream Medical Corporation, or LSM LSM has no
operating activities of significance and will not be acquired in
the Stock Purchase; and
Infusion Care Services, or ICS ICS has no operating
activities of significance and will not be acquired in the Stock
Purchase.
Estimated
Purchase Price
For purposes of preparing the pro forma combined financial
statements the $81.3 million estimated purchase price has
been allocated based on preliminary estimates of the fair values
of assets acquired and liabilities assumed at the closing date.
The estimated purchase price was determined by taking the
6,500,000 shares of NxStage common stock to be issued in
exchange for the MDS Entities valued at $12.50 per share. The
$12.50 per share was computed by taking the average trading
price of the NxStage common stock for five days before and
after June 4, 2007, the date the stock purchase agreement
was entered into and publicly announced.
Certain restructuring and integration charges may be recorded
subsequent to the acquisition, which under purchase accounting
may or may not be treated as part of the purchase price. Any
such costs are not factually supportable at this time and
therefore have not been included as pro forma adjustments. The
stock purchase agreement contains a working capital adjustment
provision that may increase or decrease the number of shares
being issued and certain indemnification provisions that may
also result in additional shares being issued. See The
Stock Purchase Stock Purchase
Consideration Working Capital Adjustment Following
Closing for additional information regarding potential
adjustments to the purchase price.
For purposes of preparing the pro forma combined financial
statements the estimated purchase price has been allocated based
on the following preliminary estimates:
|
|
|
|
|
|
Net book value of the MDS Entities
|
|
$
|
2,622
|
|
Increase in inventory
|
|
|
795
|
|
Identifiable intangible assets
|
|
|
32,360
|
|
Goodwill
|
|
|
48,973
|
|
|
|
|
|
|
Estimated purchase price
|
|
$
|
84,750
|
|
|
|
|
|
|
Purchase Consideration and Costs:
|
|
|
|
|
Fair value of common stock
exchanged
|
|
$
|
81,250
|
|
Estimated closing costs and fees
|
|
|
3,500
|
|
|
|
|
|
|
Total estimated purchase
consideration and costs
|
|
$
|
84,750
|
|
|
|
|
|
|
137
NOTES TO UNAUDITED PRO FORMA COMBINED FINANCIAL
STATEMENTS (Continued)
|
|
1.
|
Pro forma
acquisition adjustments:
|
|
|
(a)
|
Estimated
Closing Costs and Fees
|
All transaction related costs and fees will be recorded as of
the closing date of the Stock Purchase. The estimated closing
costs and fees of $3.5 million included in the pro forma
combined financial statements represent managements best
estimates based on the information available as of the date of
this proxy statement.
|
|
(b)
|
Accounts
Receivable/Accounts Payable
|
Represents elimination of amounts NxStage owes the MDS Entities
of $665,000 at June 30, 2007 less cash in transit of
$241,000.
Amount required to increase MDS Entities inventory on hand
at June 30, 2007 to $795,000, its estimated selling price
less costs of disposal and reasonable profit (step up).
Entry to record approximately $32.4 million of acquired
definite-lived intangible assets. These definite-lived
intangible assets are expected to be amortized over periods
ranging from 4 to 13 years with an average life of
11.9 years. The estimated value of these definite-lived
intangible assets was primarily based on information and
assumptions developed by NxStage management and certain publicly
available information. These estimates may be adjusted based
upon the results of the final valuation, which is expected to be
completed within 12 months after the completion of the
Stock Purchase.
For purposes of preparing the pro forma combined financial
statements the purchase price has been allocated to
definite-lived intangible assets as follows:
|
|
|
|
|
$25.0 million of customer-related intangible assets,
customer contracts and related customer relationships and
non-contractual customer relationships;
|
|
|
|
$6.3 million of technology-based intangible assets,
patented and unpatented technology, as well as core and
completed technology, trade secrets and manufacturing know-how;
and
|
|
|
|
$1.1 million of marketing-related intangible assets, trade
marks and trade names and currently-marketed products.
|
The $49.0 million estimated excess of the purchase price
over the amounts assigned to acquired assets and liabilities,
and any acquired intangible assets that cannot be recognized
apart from goodwill, has been recorded as goodwill in accordance
with Statement of Financial Accounting Standards, or SFAS,
No. 141, Business Combinations. Goodwill and other
intangible assets acquired that have indefinite lives will not
be amortized in accordance with SFAS No. 142,
Goodwill and Other Intangible Assets.
NxStage believes the factors contributing to a purchase price
that results in the recognition of goodwill include (but are not
limited to), increased manufacturing capacity and efficiency,
securing long-term rights to certain technology and brand names
and strengthening long-term customer relationships common to
Medisystems and NxStage.
(f) To
eliminate Medisystems historical equity and record issuance of
6,500,000 shares of NxStage common stock upon closing of
the Stock Purchase. The value of the common stock to be issued
is
138
NOTES TO UNAUDITED PRO FORMA COMBINED FINANCIAL
STATEMENTS (Continued)
approximately $81.3 million based upon the trading price of
NxStages common stock for five days before and after
June 4, 2007, the date the stock purchase agreement was
entered into and publicly announced as follows:
|
|
|
|
|
Common stock
|
|
$
|
7
|
|
Additional paid-in-capital
|
|
|
81,243
|
|
Elimination of Medisystems common
stock
|
|
|
(287
|
)
|
Elimination of Medisystems
accumulated earnings
|
|
|
(2,367
|
)
|
Elimination of Medisystems
accumulated other comprehensive loss
|
|
|
32
|
|
|
|
|
|
|
|
|
$
|
78,628
|
|
|
|
|
|
|
|
|
|
|
(g)
|
To eliminate sales and cost of sales from Medisystems to NxStage
of $3.7 million and $3.5 million for the six months
ended June 30, 2007, respectively, and $4.5 million
and $4.0 million for the year ended December 31, 2006,
respectively.
|
|
|
(h)
|
To record amortization of definite-lived intangibles. Had the
definite-lived intangibles been acquired at the beginning of the
periods presented, related amortization expense would have been
$1.5 million for the six months ended June 30, 2007,
and $2.9 million for the year ended December 31, 2006.
|
|
|
|
|
(i)
|
To eliminate royalty expense incurred by the MDS Entities. The
expense will no longer be incurred as a result of a fully paid
license agreement executed on June 1, 2007, between
MDS Entities and DSU Medical. As part of this
agreement, no royalties were incurred by the MDS Entities
subsequent to December 31, 2006.
|
|
|
(j)
|
Weighted
Average Shares Outstanding
|
The 6,500,000 shares of NxStage common stock expected to be
issued in connection with the Stock Purchase are included in the
computation of weighted average shares outstanding for the
six months ended June 30, 2007 as if they were issued
on January 1, 2007 and for the year ended December 31,
2006 as if they were issued on January 1, 2006.
139
NOTES TO UNAUDITED PRO FORMA COMBINED FINANCIAL
STATEMENTS (Continued)
|
|
2.
|
MDS
Entities Historical Assets, Liabilities and
Stockholders Equity
|
The Medisystems Group Combined column below includes the
balances of MDS, MDM, MDE, MRC, MSC, LSM, and ICS. Intercompany
transactions and balances have been eliminated in the
combination. The Excluded Entities column includes amounts
related to entities not being acquired by NxStage but included
in the Medisystems Group combined financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2007
|
|
|
|
Medisystems
|
|
|
Excluded
|
|
|
|
|
|
|
Group
|
|
|
Entities
|
|
|
MDS
|
|
|
|
Combined
|
|
|
(Note 3)
|
|
|
Entities
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
941
|
|
|
$
|
(139
|
)
|
|
$
|
802
|
|
Accounts receivable, net
|
|
|
4,837
|
|
|
|
|
|
|
|
4,837
|
|
Inventory
|
|
|
8,668
|
|
|
|
|
|
|
|
8,668
|
|
Prepaid and other current assets
|
|
|
1,663
|
|
|
|
(45
|
)
|
|
|
1,618
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
16,109
|
|
|
|
(184
|
)
|
|
|
15,925
|
|
Property and equipment, net
|
|
|
3,726
|
|
|
|
(225
|
)
|
|
|
3,501
|
|
Other assets
|
|
|
138
|
|
|
|
(3
|
)
|
|
|
135
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
19,973
|
|
|
$
|
(412
|
)
|
|
$
|
19,561
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY
|
Accounts payable
|
|
$
|
9,240
|
|
|
$
|
(80
|
)
|
|
$
|
9,160
|
|
Accrued expenses
|
|
|
2,467
|
|
|
|
|
|
|
|
2,467
|
|
Due to affiliate
|
|
|
4,539
|
|
|
|
|
|
|
|
4,539
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
16,246
|
|
|
|
(80
|
)
|
|
|
16,166
|
|
Deferred rent obligation
|
|
|
34
|
|
|
|
|
|
|
|
34
|
|
Long-term obligations
|
|
|
739
|
|
|
|
|
|
|
|
739
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
17,019
|
|
|
|
(80
|
)
|
|
|
16,939
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
443
|
|
|
|
(156
|
)
|
|
|
287
|
|
Accumulated earnings
|
|
|
2,543
|
|
|
|
(176
|
)
|
|
|
2,367
|
|
Accumulated other comprehensive
income
|
|
|
(32
|
)
|
|
|
|
|
|
|
(32
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
2,954
|
|
|
|
(332
|
)
|
|
|
2,622
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity
|
|
$
|
19,973
|
|
|
$
|
(412
|
)
|
|
$
|
19,561
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
140
NOTES TO UNAUDITED PRO FORMA COMBINED FINANCIAL
STATEMENTS (Continued)
|
|
3.
|
Excluded
Entities Assets, Liabilities and Stockholders
Equity
|
Provided below are the assets, liabilities and
stockholders equity of the Excluded Entities, which are
included in the Medisystems Group June 30, 2007 combined
balance sheet but will not be acquired by NxStage:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2007
|
|
|
Excluded
|
|
|
|
|
|
|
MRC
|
|
|
LSM
|
|
|
ICS
|
|
|
Entities
|
|
|
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
5
|
|
|
$
|
125
|
|
|
$
|
9
|
|
|
$
|
139
|
|
|
|
|
|
Accounts receivable, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid and other current assets
|
|
|
36
|
|
|
|
9
|
|
|
|
|
|
|
|
45
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
41
|
|
|
|
134
|
|
|
|
9
|
|
|
|
184
|
|
|
|
|
|
Property and equipment, net
|
|
|
225
|
|
|
|
|
|
|
|
|
|
|
|
225
|
|
|
|
|
|
Other assets
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
269
|
|
|
$
|
134
|
|
|
$
|
9
|
|
|
$
|
412
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY
|
Accounts payable
|
|
$
|
80
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
80
|
|
|
|
|
|
Accrued expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
80
|
|
|
|
|
|
|
|
|
|
|
|
80
|
|
|
|
|
|
Deferred rent obligation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
80
|
|
|
|
|
|
|
|
|
|
|
|
80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
17
|
|
|
|
134
|
|
|
|
9
|
|
|
|
160
|
|
|
|
|
|
Accumulated earnings
|
|
|
172
|
|
|
|
|
|
|
|
|
|
|
|
172
|
|
|
|
|
|
Accumulated other comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
189
|
|
|
|
134
|
|
|
|
9
|
|
|
|
332
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity
|
|
$
|
269
|
|
|
$
|
134
|
|
|
$
|
9
|
|
|
$
|
412
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
141
NOTES TO UNAUDITED PRO FORMA COMBINED FINANCIAL
STATEMENTS (Continued)
|
|
4.
|
MDS
Entities Historical Six Months Ended June 30,
2007
|
The Medisystems Group Combined column below includes the
unaudited historical operating results of the combined
Medisystems Group, which includes MDS, MDM, MDE, MRC, MTC, MSC,
LSM and ICS. The combined results of the Medisystems Group
exclude intercompany transactions and balances. The Excluded
Entities column below represents the results of operations of
the Excluded Entities, which are included in the Medisystems
Group unaudited combined statement of operations but will not be
acquired by NxStage.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2007
|
|
|
|
Medisystems
|
|
|
Excluded
|
|
|
|
|
|
|
Group
|
|
|
Entities
|
|
|
MDS
|
|
|
|
Combined
|
|
|
(Note 5)
|
|
|
Entities
|
|
|
Revenues
|
|
$
|
32,028
|
|
|
$
|
|
|
|
$
|
32,028
|
|
Cost of revenues
|
|
|
23,275
|
|
|
|
|
|
|
|
23,275
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
8,753
|
|
|
|
|
|
|
|
8,753
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
922
|
|
|
|
|
|
|
|
922
|
|
Research and development
|
|
|
877
|
|
|
|
(369
|
)
|
|
|
508
|
|
Distribution
|
|
|
491
|
|
|
|
|
|
|
|
491
|
|
General and administrative
|
|
|
1,779
|
|
|
|
(83
|
)
|
|
|
1,696
|
|
Royalty to affiliate
|
|
|
2,661
|
|
|
|
|
|
|
|
2,661
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
6,730
|
|
|
|
(452
|
)
|
|
|
6,278
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations
|
|
|
2,023
|
|
|
|
452
|
|
|
|
2,475
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income
|
|
|
149
|
|
|
|
|
|
|
|
149
|
|
Interest and other expense
|
|
|
(109
|
)
|
|
|
|
|
|
|
(109
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
|
|
|
40
|
|
|
|
|
|
|
|
40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before foreign income taxes
|
|
|
2,063
|
|
|
|
452
|
|
|
|
2,515
|
|
Provision for foreign income taxes
|
|
|
(126
|
)
|
|
|
|
|
|
|
(126
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
1,937
|
|
|
$
|
452
|
|
|
$
|
2,389
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
142
NOTES TO UNAUDITED PRO FORMA COMBINED FINANCIAL
STATEMENTS (Continued)
|
|
5.
|
Excluded
Entities Six Months Ended June 30,
2007
|
Provided below are the operating results of the Excluded
Entities, which are included in the Medisystems Group combined
results of operations for the six months ended June 30,
2007 but will not be acquired by NxStage:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
|
|
June 30, 2007
|
|
|
Excluded
|
|
|
|
MTC
|
|
|
MRC
|
|
|
LSM
|
|
|
ICS
|
|
|
Entities
|
|
|
Revenues
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Cost of revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
|
|
369
|
|
|
|
|
|
|
|
|
|
|
|
369
|
|
Distribution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
75
|
|
|
|
|
|
|
|
7
|
|
|
|
1
|
|
|
|
83
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
75
|
|
|
|
369
|
|
|
|
7
|
|
|
|
1
|
|
|
|
452
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(75
|
)
|
|
|
(369
|
)
|
|
|
(7
|
)
|
|
|
(1
|
)
|
|
|
(452
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(75
|
)
|
|
|
(369
|
)
|
|
|
(7
|
)
|
|
|
(1
|
)
|
|
|
(452
|
)
|
Income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(75
|
)
|
|
$
|
(369
|
)
|
|
$
|
(7
|
)
|
|
$
|
(1
|
)
|
|
$
|
(452
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
143
NOTES TO UNAUDITED PRO FORMA COMBINED FINANCIAL
STATEMENTS (Continued)
|
|
6.
|
MDS
Entities Year Ended December 31, 2006
|
The Medisystems Group combined column below includes the
historical operating results of the combined Medisystems Group,
which includes MDS, MDM, MDE, MRC, MTC, MSC, LSM and ICS. The
combined results of the Medisystems Group exclude intercompany
transactions and balances. The amounts included in the Excluded
Entities column represent the results of operations of the
Excluded Entities, which are included in the Medisystems Group
statement of operations but will not be acquired by NxStage.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2006
|
|
|
|
Medisystems
|
|
|
Excluded
|
|
|
|
|
|
|
Group
|
|
|
Entities
|
|
|
MDS
|
|
|
|
Combined
|
|
|
(Note 7)
|
|
|
Entities
|
|
|
Revenues
|
|
$
|
62,577
|
|
|
$
|
(2
|
)
|
|
$
|
62,575
|
|
Cost of revenues
|
|
|
47,782
|
|
|
|
|
|
|
|
47,782
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
14,795
|
|
|
|
(2
|
)
|
|
|
14,793
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
2,280
|
|
|
|
|
|
|
|
2,280
|
|
Research and development
|
|
|
2,317
|
|
|
|
(856
|
)
|
|
|
1,461
|
|
Distribution
|
|
|
1,238
|
|
|
|
|
|
|
|
1,238
|
|
General and administrative
|
|
|
4,382
|
|
|
|
(620
|
)
|
|
|
3,762
|
|
Royalty to affiliate
|
|
|
4,350
|
|
|
|
1,450
|
|
|
|
5,800
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
14,567
|
|
|
|
(26
|
)
|
|
|
14,541
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations
|
|
|
228
|
|
|
|
24
|
|
|
|
252
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Legal settlement
|
|
|
5,629
|
|
|
|
(5,629
|
)
|
|
|
|
|
Interest and other income
|
|
|
284
|
|
|
|
(2
|
)
|
|
|
282
|
|
Interest and other expense
|
|
|
(251
|
)
|
|
|
|
|
|
|
(251
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
5,662
|
|
|
|
(5,631
|
)
|
|
|
31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before foreign income taxes
|
|
|
5,890
|
|
|
|
(5,607
|
)
|
|
|
283
|
|
Provision for foreign income taxes
|
|
|
199
|
|
|
|
|
|
|
|
199
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
5,691
|
|
|
$
|
(5,607
|
)
|
|
$
|
84
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
144
NOTES TO UNAUDITED PRO FORMA COMBINED FINANCIAL
STATEMENTS (Continued)
|
|
7.
|
Excluded
Entities Year Ended December 31, 2006
|
Provided below are operating results of entities that are
included in the Medisystems Group combined results of operations
for the year ended December 31, 2006 but will not be
acquired by NxStage.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2006
|
|
|
Excluded
|
|
|
|
MTC
|
|
|
MRC
|
|
|
LSM
|
|
|
ICS
|
|
|
Entities
|
|
|
Revenues
|
|
$
|
|
|
|
$
|
2
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
2
|
|
Cost of revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
|
|
856
|
|
|
|
|
|
|
|
|
|
|
|
856
|
|
Distribution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
606
|
|
|
|
|
|
|
|
13
|
|
|
|
1
|
|
|
|
620
|
|
Royalty to affiliate
|
|
|
(1,450
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,450
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
(844
|
)
|
|
|
856
|
|
|
|
13
|
|
|
|
1
|
|
|
|
26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
844
|
|
|
|
(854
|
)
|
|
|
(13
|
)
|
|
|
(1
|
)
|
|
|
(24
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Legal settlement
|
|
|
5,629
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,629
|
|
Interest and other income
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
Interest and other expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
5,631
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,631
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes
|
|
|
6,475
|
|
|
|
(854
|
)
|
|
|
(13
|
)
|
|
|
(1
|
)
|
|
|
5,607
|
|
Income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
6,475
|
|
|
$
|
(854
|
)
|
|
$
|
(13
|
)
|
|
$
|
(1
|
)
|
|
$
|
5,607
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
145
DESCRIPTION
OF NxSTAGE CAPITAL STOCK
Our authorized capital stock consists of 100,000,000 shares
of common stock, par value $.001 per share, and
5,000,000 shares of preferred stock, par value $.001 per
share, all of which shares of preferred stock are undesignated.
Our board of directors may establish the rights and preferences
of the preferred stock from time to time. As of July 31,
2007, there were 29,995,126 shares of common stock issued
and outstanding. As of July 31, 2007, there were 86
stockholders of record of our capital stock.
Holders of common stock are entitled to one vote for each share
held on all matters submitted to a vote of stockholders and do
not have cumulative voting rights. Accordingly, holders of a
majority of the shares of common stock entitled to vote in any
election of directors may elect all of the directors standing
for election. Holders of common stock are entitled to receive
proportionately any dividends as may be declared by our board of
directors, subject to any preferential dividend rights of
outstanding preferred stock. Upon our liquidation, dissolution
or winding up, the holders of common stock are entitled to
receive proportionately our net assets available after the
payment of all debts and other liabilities and subject to the
prior rights of any outstanding preferred stock. Holders of
common stock have no preemptive, subscription, redemption or
conversion rights. The outstanding shares of our common stock
are, and the shares issuable by us pursuant to the Stock
Purchase will be, when issued and paid for, fully paid and
nonassessable. The rights, preferences and privileges of holders
of common stock are subject to, and may be adversely affected
by, the rights of the holders of shares of any series of
preferred stock that we may designate and issue in the future.
Under the terms of the our certificate of incorporation, our
board of directors is authorized to issue shares of preferred
stock in one or more series without stockholder approval. Our
board of directors has the discretion to determine the rights,
preferences, privileges and restrictions, including voting
rights, dividend rights, conversion rights, redemption
privileges and liquidation preferences, of each series of
preferred stock.
The purpose of authorizing our board of directors to issue
preferred stock and determine its right and preferences is to
eliminate delays associated with a stockholder vote on specific
issuances. The issuance of preferred stock, while providing
flexibility in connection with possible future acquisitions and
other corporate purposes, will affect, and may adversely affect,
the rights of holders of any preferred stock that may be issued
in the future. It is not possible to state the actual effect of
the issuance of any shares of preferred stock on the rights of
holders of common stock until the board of directors determines
the specific rights attached to that preferred stock. The
effects of issuing preferred stock could include one or more of
the following:
|
|
|
|
|
restricting dividends on the common stock;
|
|
|
|
diluting the voting power of the common stock;
|
|
|
|
impairing the liquidation rights of the common stock; or
|
|
|
|
delaying or preventing changes in control or management of
NxStage.
|
We have no present plans to issue any shares of preferred stock.
As of June 30, 2007:
|
|
|
|
|
Lighthouse Capital Partners IV, L.P. held a warrant to purchase
36,730 shares of our common stock at an exercise price of
$8.17 per share. This warrant expires on December 23, 2011.
|
|
|
|
Lighthouse Capital Partners V, L.P. held a warrant to
purchase 36,730 shares of our common stock at an exercise
price of $8.17 per share. The warrant expires on
December 23, 2011.
|
146
These warrants provide for adjustments in the event of stock
dividends, stock splits, reclassifications or other changes in
our corporate structure. Certain of the holders of these
warrants have registration rights that are outlined below under
Registration Rights.
Millennium Technology Ventures, LP. has the right to acquire,
for no additional consideration, 1,904 shares of our common
stock if and when it exercises a warrant it holds to purchase
shares of VascA, Inc. preferred stock.
As of June 30, 2007, options to purchase an aggregate of
3,153,724 shares of common stock at a weighted-average
exercise of $7.37 per share were outstanding.
The holders of 13,511,174 shares of common stock and the
holders of warrants to purchase 73,460 shares of our common
stock have rights to require us to file registration statements
under the Securities Act or to include their shares in
registration statements that we may file in the future for us or
other stockholders.
The holders of more than 30% of the shares having registration
rights may demand that we register all or a portion of their
common stock for sale under the Securities Act of 1933, as
amended, so long as the aggregate offering price of such
securities is reasonably anticipated to be at least $5,000,000.
We will effect the registration as requested, unless the
underwriters decide to limit the number of shares that may be
included in the registration due to marketing factors. We are
required to effect two of these registrations. However, if at
any time we become eligible to file a registration statement on
Form S-3,
or any successor form, holders of registration rights may make
two requests for us to effect a registration on such forms of
their common stock having an aggregate offering price of at
least $500,000.
In addition, if at any time after this offering we register any
shares of common stock, either for its own account or for the
account of other security holders, the holders of registration
rights are entitled to notice of the registration and to include
all or a portion of their common stock in the registration. A
holders right to demand or include shares in a
registration is subject to the right of the underwriters to
limit the number of shares included in the offering.
Anti-Takeover
Provisions of Delaware Law, Our Certificate of Incorporation and
Our Bylaws
We are subject to the provisions of Section 203 of the
General Corporation Law of Delaware. Subject to certain
exceptions, Section 203 prohibits a publicly held Delaware
corporation from engaging in a business combination with an
interested stockholder for a period of three years after the
person became an interested stockholder, unless the interested
stockholder attained such status with the approval of our board
of directors or the business combination is approved in a
prescribed manner. A business combination includes, among other
things, a merger or consolidation involving us and the
interested stockholder and the sale of more than 10% of our
assets. In general, an interested stockholder is any entity or
person beneficially owning 15% or more of our outstanding voting
stock and any entity or person affiliated with or controlling or
controlled by such entity or person.
Under our bylaws, any vacancy on our board of directors,
including a vacancy resulting from an enlargement of our board
of directors, may only be filled by vote of a majority of our
directors then in office. The limitations on the removal of
directors and filling of vacancies could make it more difficult
for a third party to acquire, or discourage a third party from
acquiring, control of us.
Our certificate of incorporation and our bylaws also provide
that any action required or permitted to be taken by our
stockholders at an annual meeting or special meeting of
stockholders may only be taken if it is properly brought before
the meeting and may not be taken by written action in lieu of a
meeting. Our certificate of incorporation and our bylaws further
provide that, except as otherwise required by law, special
meetings of the stockholders may only be called by the chairman
of the board, chief executive officer or our board of directors.
In addition, our bylaws establish an advance notice procedure
for stockholder proposals to
147
be brought before an annual meeting of stockholders, including
proposed nominations of persons for election to the board of
directors. Stockholders at an annual meeting may only consider
proposals or nominations specified in the notice of meeting or
brought before the meeting by or at the direction of the board
of directors or by a stockholder of record on the record date
for the meeting, who is entitled to vote at the meeting and who
has delivered timely written notice in proper form to our
secretary of the stockholders intention to bring such
business before the meeting. These provisions could have the
effect of delaying until the next stockholders meeting
stockholder actions that are favored by the holders of a
majority of our outstanding voting securities. These provisions
may also discourage a third party from making a tender offer for
our common stock, because even if it acquired a majority of our
outstanding voting securities, the third party would be able to
take action as a stockholder, such as electing new directors or
approving a merger, only at a duly called stockholders
meeting, and not by written consent.
The General Corporation Law of Delaware provides generally that
the affirmative vote of a majority of the shares entitled to
vote on any matter is required to amend a corporations
certificate of incorporation or bylaws, unless a
corporations certificate of incorporation or bylaws, as
the case may be, requires a greater percentage. Our certificate
of incorporation and bylaws require the affirmative vote of the
holders of at least 75% of the shares of our capital stock
issued and outstanding and entitled to vote to amend or repeal
any of the provisions described in the prior two paragraphs.
Limitation
of Liability and Indemnification
Our certificate of incorporation contains provisions permitted
under the General Corporation Law of Delaware relating to the
liability of directors. The provisions eliminate a
directors liability for monetary damages for a breach of
fiduciary duty, except in circumstances involving wrongful acts,
such as the breach of a directors duty of loyalty or acts
or omissions that involve intentional misconduct or a knowing
violation of law. Further, our certificate of incorporation
contains provisions to indemnify our directors and officers to
the fullest extent permitted by the General Corporation Law of
Delaware.
Transfer
Agent and Registrar
The transfer agent and registrar for our common stock is
Computershare Trust Company, Inc.
Our common stock is quoted on the NASDAQ Global Market under the
symbol NXTM.
148
NxSTAGE
EXECUTIVE OFFICER AND DIRECTOR COMPENSATION
Compensation
Discussion and Analysis
Our
Executive Compensation Philosophy and Objectives
Our executive compensation philosophy is to provide our
executives with appropriate and competitive individual pay
opportunities, with total compensation significantly influenced
by the attainment of corporate and individual performance
objectives and the creation of shareholder value. The primary
objectives of our executive compensation program are to:
|
|
|
|
|
attract, retain and reward executives who can help us to achieve
our business objectives;
|
|
|
|
promote the achievement of key strategic and financial
performance measures by linking short- and long-term cash and
equity incentives to the achievement of measurable corporate and
individual performance goals; and
|
|
|
|
align executives long-term incentives with the interests
of our stockholders.
|
To achieve these objectives, the Compensation Committee
evaluates our executive compensation program with the goal of
setting compensation at levels the Committee believes are
competitive with those of other companies in our industry and
our region that compete with us for executive talent. In
addition, our executive compensation program ties a significant
portion of each executives overall compensation to key
strategic, financial and operational goals such as growth in our
customer base, new product development initiatives,
implementation of appropriate financing strategies, and
achievement of our sales and operating goals, as measured by
metrics such as revenue and net loss. We also provide a portion
of our executive compensation in the form of stock option and
restricted stock grants that vest over time, which we believe
helps to retain our executives and aligns their interests with
those of our stockholders by allowing them to participate in the
longer-term success of NxStage as reflected in stock price
appreciation.
How
Executive Compensation is Determined
Our Compensation Committee has primary responsibility for
reviewing, setting and approving the compensation of our named
executive officers. In fulfilling this responsibility, the
Compensation Committee relies on three key elements: market
referencing, performance considerations, and Chief Executive
Officer and Compensation Committee judgment.
Market Referencing Against a Peer Group. We
base our compensation decisions on market considerations, by
benchmarking our executive compensation against compensation
paid to employees in comparable roles at peer companies. We
engaged the services of the Hay Group prior to our initial
public offering to help us collect this market information, and
establish the group of companies originally included in our peer
compensation group, which we refer to as our Peer Group. The
Compensation Committee expects to periodically review and update
this Peer Group, to ensure that those included are generally
comparable to our company and are representative of those
companies against which we compete for executive talent. An
update of the Hay Groups Peer Group analysis was not
performed in 2006. The Compensation Committee expects to engage
a compensation consultant to review and update the Hay
Groups Peer Group analysis later this year.
We generally target base salaries and executive benefits at the
50th percentile, incentive performance awards at the
75th percentile and the grant value of equity awards at the
75th percentile of the Peer Group. These are overall
guidelines, and variations to these general targets may occur as
dictated by the experience level of the individual and market
factors.
Performance Considerations. In addition to
considering market rates for executive compensation, we award
our executives compensation in recognition of their performance
as a team in achieving our business objectives, as well as their
individual performance. To assist our evaluation of executive
performance, we conduct an annual Performance Review. The
Performance Review process is designed to guide performance
discussions, establish performance objectives and communicate
annual achievements. Our Chief Executive Officer conducts each
named executive officers Performance Review, in
consultation with the Audit
149
Committee for the chief financial officer, and the Compensation
Committee conducts the Performance Review for the Chief
Executive Officer.
Chief Executive Officer and Compensation Committee
Judgment. Our total compensation program operates
not only based on the application of market referencing and
corporate and individual performance considerations, but also
through the application of Chief Executive Officer and
Compensation Committee judgment. We do not employ a purely
formulaic approach to any of our compensation plans. There are
guidelines in place, but there are also individual performance
factors and executive retention considerations that permit
discretion to increase or decrease cash and equity awards based
on those considerations.
In making its compensation determinations, the Compensation
Committee reviews the total of all elements of compensation for
each of our executive officers. In addition, the Compensation
Committee considers the economic value as well as the retentive
value of prior equity grants received by our named executives in
determining current and future compensation, and considers each
executives compensation compared to the compensation of
other executives and other employees generally. In determining
the reasonableness of our executives total compensation,
the Compensation Committee reviews not only individual and
corporate performance compared to plan, but also the nature of
each element of executive compensation provided, including
salary, bonus, long-term incentive compensation, and accumulated
realized and unrealized stock option grants, as well as the
terms of executive severance and change in control arrangements.
In addition, while the Compensation Committee is solely
responsible for setting the targets and approving the awards,
the Compensation Committee relies on the judgment of the Chief
Executive Officer regarding evaluating the actual performance of
each executive (other than the Chief Executive Officer) against
those through the Performance Review process and recommending
appropriate salary and incentive awards. The Chief Executive
Officer participates in Compensation Committee meetings, at the
request of the Compensation Committee, in order to provide
background information and explanations supporting his
recommendations.
Components
of our Executive Compensation Program
Overview of Compensation. Our executive
compensation program consists of fixed compensation elements,
such as base salary and benefits, and variable performance-based
elements, such as annual and long-term incentives. Our fixed
compensation elements are designed to provide a stable source of
income and financial security to our executives. Our variable
performance-based compensation elements are designed to reward
performance at three levels: individual performance, actual
corporate performance compared to annual business goals, and
corporate performance in terms of long-term shareholder value
creation. Through these performance incentive awards, we reward
the achievement of short-term goals, such as annual growth in
our chronic patient numbers or our critical care business,
annual reductions in cost of goods, and completion of key
business agreements, and long-term goals, such as business
growth, product innovation and stock price appreciation.
We compensate our executives primarily through base salary,
performance based annual cash incentive bonuses and equity
awards. This three-part compensation approach enables us to
remain competitive with our industry peers and Peer Group while
ensuring that executives are appropriately incentivized to
deliver short-term results while creating long-term shareholder
value.
We do not have any formal or informal policy or target for
allocating compensation between long-term and short-term
compensation, between cash and non-cash compensation or among
the different forms of non-cash compensation. Instead, the
Compensation Committee, after reviewing publicly available
information regarding the executive compensation of the Peer
Group, determines subjectively what it believes to be the
appropriate level and mix of the various compensation
components. The Compensation Committee has chosen to put a
significant percentage of each executives pay at risk,
contingent upon the achievement of certain goals within our
strategic plan and overall corporate achievement.
150
Base
Salary
Base salary is used to recognize the experience, skills,
knowledge and responsibilities required of all of our employees,
including our executives. When establishing base salaries, the
Compensation Committee considers compensation in the Peer Group,
other available compensation survey data, as well as a variety
of other factors, including the seniority of the individual, the
level of the individuals responsibility, the ability to
replace the individual, the base salary of the individual at his
or her prior place of employment, if applicable, and the number
of well qualified candidates to assume the individuals
role.
Base salaries are reviewed at least annually by our Compensation
Committee, and are adjusted from time to time to realign
salaries with market levels after taking into account individual
responsibilities, performance and experience. Effective
January 1, 2006, each of our named executives received
increases in base salary (between 3% and 7%), consistent with
those increases generally reported in compensation surveys we
purchased, including surveys purchased from Top Five Data
Service, Inc. and The Survey Group. In November 2006, we
adjusted the base salary of Winifred L. Swan, our Senior Vice
President and General Counsel, to recognize her increased
responsibilities following our initial public offering and to
adjust her compensation to better reflect rates paid to other
individuals within the region and industry with similar levels
of experience and responsibilities. We also hired Robert S.
Brown, our new Senior Vice President and Chief Financial Officer
in November 2006. In setting his compensation, we looked to his
compensation at his prior company and to the compensation of
other chief financial officers within the region and industry
with similar levels of experience and roles.
Ms. Swans and Mr. Browns compensation was
not adjusted in 2007 as their compensation was adjusted, in the
case of Ms. Swan, and initially established, in the case of
Mr. Brown, in November 2006. Messrs. Burbank, Turk and
Licari received increases in base salary, effective as of
January 1, 2007, in acknowledgement, in the case of
Messrs. Burbank and Turk, of their expanded
responsibilities as we continue to grow, and in the case of
Mr. Burbank, his expanded responsibilities following our
becoming a public company.
Annual
Cash Incentive Bonus
We have an annual cash incentive bonus plan for our executives.
The annual cash incentive bonuses are intended to compensate for
the achievement of both corporate and individual performance
objectives. Amounts payable under the annual cash incentive
bonus plan are calculated as a percentage of the applicable
executives base salary, with higher ranked executives
typically being compensated at a higher percentage of base
salary. The corporate targets and the individual objectives are
given roughly equal weight in the bonus analysis. The corporate
targets generally conform to the financial metrics contained in
the internal business plan adopted by the board of directors.
Individual objectives are necessarily tied to the particular
area of expertise of the employee and their performance in
attaining those objectives relative to external forces, internal
resources utilized and overall individual effort. The
Compensation Committee works with the Chief Executive Officer to
develop corporate and individual goals that they believe can be
reasonably achieved with hard work over the next year.
The Compensation Committee approved our 2006 Corporate Bonus
Plan in March 2006. Awards under the Plan for named executive
officers were based on a comparison of individual performance
against pre-determined individual goals and actual corporate
results against our sales and operating expense budget, as
measured by the following metrics: revenues and operating
expenses.
The target bonus awards, as a percentage of base salary, for
2006 for the named executive officers under the 2006 Corporate
Bonus Plan were: 35% of base salary for all named executives,
other than the Chief Executive Officer, whose target bonus award
was 45% of base salary. Actual awards to named executives for
performance in 2006 were approximately 29% for Mr. Turk and
Ms. Swan, 23% for Mr. Licari; 35% for Mr. Brown,
as agreed to in his employment agreement with us for 2006, and
approximately 38% for Mr. Burbank. These awards reflected
the Committees assessment of individual executive
performance as well as the fact that, although we exceeded our
revenue target in the 2006 Corporate Bonus Plan, we did not meet
our pre-tax loss target under the Plan. As reflected in the
Summary Compensation Table appearing on page 155 of this
proxy statement, Messrs. Burbank and Turk did not receive
payment of their full awards under the
151
2006 Corporate Bonus Plan, pursuant to an earlier action by our
board of directors requiring that bonuses earned by such
individuals between 2004 and 2006 be offset against a portion of
the tax
gross-up
paid to such individuals in connection with the forgiveness of
all of their indebtedness to NxStage in 2004.
The Compensation Committee approved our 2007 Corporate Bonus
Plan in April 2007. Under this plan, each named executive
officers 2007 bonus payout will be determined based on a
comparison of individual performance against pre-determined
individual goals and actual corporate results against our sales
and operating expense budget, as measured by the following
metrics: chronic patient numbers, critical care sales, cost of
goods sold and operating expenses, as well as such other metrics
as may be added within the discretion of the Compensation
Committee as changes within our business environment may dictate.
The target 2007 bonus awards, as a percentage of salary, for
named executive officers under the 2007 Corporate Bonus Plan
are: 35% of base salary for all named executives other than the
Chief Executive Officer and Senior Vice President of Commercial
Operations, whose target bonus awards are 50% and 45%,
respectively.
Special
Recognition Awards
In addition to cash payments under Compensation Committee
approved annual cash incentive bonus plans, we periodically make
special awards in recognition of extraordinary achievements. For
example, in April 2007, we granted special recognition bonuses
to a few employees who were instrumental to the completion of
our recently announced agreements with three dialysis chains.
Recipients included two named executive officers:
Messrs. Burbank and Turk.
Signing
Bonuses
We also occasionally award cash signing bonuses when executives
first join us. Such cash signing bonuses typically must be
repaid in full if the executive voluntarily terminates
employment with us prior to the first anniversary of the date of
hire. Whether a signing bonus is paid and the amount of the
bonus is determined on a
case-by-case
basis under the specific hiring circumstances. For example, we
will consider paying signing bonuses to compensate for amounts
forfeited by an executive upon terminating prior employment, to
assist with relocation expenses or to create additional
incentive for an executive to join us in a position where there
is high market demand. In 2006, we paid an $82,000 signing bonus
to Robert S. Brown, our new Senior Vice President and Chief
Financial Officer, to compensate him for the incentive bonus he
forfeited when he left his prior employer to join NxStage in
November 2006.
The salaries paid and the cash bonuses awarded for 2006 to our
named executive officers are shown in the Summary Compensation
Table on page 155 of this proxy statement.
Stock
Option and Restricted Stock Awards
Our equity award program is the primary vehicle for offering
long-term incentives to our executives. We believe that equity
awards provide our executives with a strong link to our
long-term performance, create an ownership culture and help to
align the interests of our executives and our stockholders. In
addition, the vesting feature of our equity awards should
further our goal of executive retention because this feature
provides an incentive to our executives to remain in our employ
during the vesting period. In determining the size of equity
awards to our executives, our Compensation Committee considers
comparative share ownership of executives in our compensation
Peer Group, our business performance, the applicable
executives performance, the amount of equity previously
awarded to the executive, the vesting of such awards and the
recommendations of management.
We typically make an initial equity award of stock options to
new executives and subsequent equity grants of options or
restricted stock from time to time thereafter as part of our
overall executive compensation program. All grants of options
and restricted stock to our executives are approved by the
Compensation Committee.
152
We did not make an annual equity award to our named executives
in 2006, but did make the following grants to named executives
in 2006, outside of our annual grant program:
(i) 7,422 shares of restricted common stock were
granted to David N. Gill, our former Senior Vice President and
Chief Financial Officer, as payment in lieu of the cash bonus
that he would have earned during the period of 2006 preceding
his resignation, (ii) 13,027 shares of restricted
common stock were granted to Philip R. Licari, our Senior Vice
President and Chief Operating Officer, in connection with the
amendment of his initial option grant increasing the per share
exercise price of his option from $4.10 to $5.47 in response to
the requirements of Internal Revenue Code Section 409A,
(iii) 10,000 shares of restricted common stock were granted
to Winifred L. Swan, our Senior Vice President and General
Counsel, in recognition of her increased responsibilities
following our public offering, and (iv) 250,000 stock
options were granted to Robert S. Brown, our new Senior Vice
President and Chief Financial Officer, as his initial equity
award.
Our equity awards have typically taken the form of stock
options, and in limited circumstances we have also made
restricted stock grants. We typically grant restricted stock
awards at no cost to the executive. Because the shares have a
built-in value at the time the restricted stock awards are
granted, we generally grant significantly fewer shares of
restricted stock than the number of stock options we would grant
for a similar purpose. Typically, the stock options and
restricted stock we grant to our executives vest at a rate of
25% per year over a period of four years. Vesting rights cease
upon termination of employment and stock option exercise rights
cease 90 days following termination of employment, except
in the case of death or disability. Prior to the exercise of an
option, the holder has no rights as a stockholder with respect
to the shares subject to such option, including voting rights
and the right to receive dividends or dividend equivalents. We
set the exercise price of all stock options to equal the closing
price of our common stock on the NASDAQ Global Market on the
date of grant.
Elements
of Indirect Pay
In addition to the direct pay elements described above, we also
provide our executives with indirect pay in the form of
benefits. We maintain broad-based benefits that are provided to
all employees, including health and dental insurance, life and
disability insurance and a 401(k) plan. Executives are eligible
to participate in all of our employee benefit plans, in each
case on the same basis as other employees. We match 100% of the
first 3%, and 50% of the next 2%, of the employees
compensation contributed to the 401(k) plan, subject to
then-current Internal Revenue Service limits on the amount that
may be contributed by employees to such plans. All of our named
executives participate in our 401(k) plan and receive matching
contributions according to this formula.
Severance
and Change in Control Benefits
Pursuant to employment agreements we have entered into with each
of our named executive officers and our 2005 Stock Incentive
Plan, our executives are entitled to specified benefits in the
event of the termination of their employment under certain
circumstances, including termination following a change in
control of our company. The purpose of these benefits is to
ensure that we remain competitive in attracting and retaining
executives within our industry and Peer Group and that we retain
our key executives during a potentially critical time in the
event of a sale or merger of NxStage. After reviewing the
practices of companies represented in the Peer Group, we believe
that our severance and change in control benefits are generally
in line with severance packages offered to executives in the
Peer Group.
Change in Control benefits are structured as double
trigger benefits. In other words, the change in control
does not itself trigger benefits; rather, benefits are paid only
if the employment of the executive is terminated during a
specified period after the change in control. We believe a
double trigger benefit maximizes shareholder value
because it prevents an unintended windfall to executives in the
event of a friendly change in control, while still providing
them appropriate incentives to cooperate in negotiating any
change in control in which they believe they may lose their jobs.
153
We have provided more detailed information about these benefits,
along with estimates of their value under various circumstances,
under the caption Potential Termination and Change in
Control Payments below.
Tax
Considerations
Section 162(m) of the Internal Revenue Code of 1986, as
amended, generally disallows a tax deduction for compensation in
excess of $1.0 million paid to our Chief Executive Officer
and our four other most highly paid executive officers.
Qualifying performance-based compensation is not subject to the
deduction limitation if specified requirements are met. We
periodically review the potential consequences of
Section 162(m) and we generally intend to structure the
performance-based portion of our executive compensation, where
feasible, to comply with exemptions in Section 162(m) so
that the compensation remains tax deductible to us. However, the
Compensation Committee may, in its judgment, authorize
compensation payments that do not comply with the exemptions in
Section 162(m) when it believes that such payments are
appropriate to attract and retain executive talent.
Our
Equity Award Grant Practices
Historical Practices. Since our initial public
offering, all grants have been approved on an individual basis
by our Compensation Committee, with the exception of grants to
new hires below the Vice President level, which since January
2006 have been approved by the Chief Executive Officer, within
equity award guidelines for each job position pre-approved by
the Compensation Committee. New hire grants approved by the
Chief Executive Officer are made on the first Tuesday of each
month, or the next succeeding business day if such Tuesday is
not a business day, for employees below the Vice President level
hired during the preceding month.
All other equity awards have been made pursuant to the following
procedure: for non-executive employees, our Chief Executive
Officer made recommendations regarding equity award grants to
the Compensation Committee, based on input regarding individual
performance he received from appropriate management personnel.
For executive officers (other than the Chief Executive Officer),
our Chief Executive Officer made those recommendations to the
Compensation Committee based on his own assessment of each
executives performance. For the Chief Executive Officer,
our Compensation Committee made those recommendations. We have
historically granted equity awards at various times during the
year for a variety of reasons.
Current Practices. With respect to awards
granted during and after 2007, NxStage will grant equity awards
according to the following procedures:
Annual Grants. Annual awards will be granted
at a Compensation Committee meeting occurring between February
and the end of the calendar year. If the timing of this meeting
falls within a trading blackout period, equity awards will be
granted as of the first business day following the expiration of
the trading blackout period.
Promotion, Special Recognition and Retention
Grants. Promotion, special recognition and
retention awards will be granted at the discretion of the
Compensation Committee on the date of the Compensation Committee
meeting at which such awards are approved, unless such date
occurs during a trading blackout period, in which case such
awards shall be granted on the first business day following the
expiration of the trading blackout period.
New Hire Grants. New hire awards for employees
below the Vice President level will continue to be approved by
the Chief Executive Officer (pursuant to applicable equity award
guidelines for each job position) under the authority delegated
to him by the Compensation Committee and are effective upon the
Chief Executive Officers approval, which shall be made on
the first Tuesday of every month, or the next succeeding
business day if such Tuesday is not a business day, for those
employees below the Vice President level hired during the
preceding month. New hire awards for executive officers and
employees at the Vice President level and above require approval
of the Compensation Committee, and shall be approved at a
Compensation
154
Committee meeting and granted on the first Tuesday of the month,
or the next succeeding business day if such Tuesday is not a
business day, following the Compensation Committees
approval of such awards. All stock option awards are granted
with an exercise price equal to the closing price of the
NxStages common stock on the date of grant.
The following table sets forth information regarding
compensation earned by our Chief Executive Officer, our former
Chief Financial Officer, our Chief Financial Officer and each of
our three other most highly compensated executive officers
during fiscal 2006. We refer to these executive officers as our
named executive officers elsewhere in this proxy
statement.
SUMMARY
COMPENSATION TABLE
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Non-Equity
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Incentive Plan
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All Other
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Salary
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Bonus
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Stock Awards
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Option
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Compensation
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Compensation
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Total
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Name and Principal Position(1)
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Year
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($)
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($)
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($)(2)
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Awards ($)(3)
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($)(4)
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($)(5)
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($)
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Jeffrey H. Burbank
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2006
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298,700
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170,516
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112,505
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(6)
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11,745
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593,466
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President, Chief Executive
Officer and Director
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Robert S. Brown
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2006
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24,639
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(7)
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90,650
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(8)
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75
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115,319
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Senior Vice President and
Chief Financial Officer
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David N. Gill
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2006
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294,120
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(9)
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87,802
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10,302
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392,224
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Former Vice President and
Chief Financial Officer
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Philip R. Licari
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2006
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231,750
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(10)
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187,195
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54,313
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125,390
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(10)
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598,648
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Senior Vice President and
Chief Operating Officer
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Winifred L. Swan
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2006
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214,936
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(11)
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1,855
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53,286
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63,576
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9,401
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343,054
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Senior Vice President, General
Counsel
and Secretary
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Joseph E. Turk, Jr.
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2006
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223,871
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31,972
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65,583
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(12)
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11,800
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333,226
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Senior Vice President,
Commercial Operations
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(1) |
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The titles noted in the table are each officers respective
title as of December 31, 2006. Mr. Brown became our
Chief Financial Officer on November 27, 2006. Mr. Gill
served as our Chief Financial Officer through November 22,
2006. |
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(2) |
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The amounts in the Stock Awards column reflect the dollar amount
recognized as compensation cost for financial statement
reporting purposes for the fiscal year ended December 31,
2006, in accordance with FAS 123R of restricted stock
awarded under our equity plans and may include amounts from
awards granted in and prior to 2006. There can be no assurance
that the FAS 123R amounts will ever be realized. The
assumptions we used to calculate these amounts are included in
footnote 2 to our audited financial statements for the
fiscal year ended December 31, 2006 included in this proxy
statement beginning on page F-20. |
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(3) |
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The amounts in the Option Awards column reflect the dollar
amount recognized as compensation cost for financial statement
reporting purposes for the fiscal year ended December 31,
2006, in accordance with FAS 123R of stock options granted
under our equity plans and may include amounts from stock
options granted in and prior to 2006. There can be no assurance
that the FAS 123R amounts will ever be realized. The
assumptions we used to calculate these amounts are included in
footnote 2 to our audited financial statements for the
fiscal year ended December 31, 2006 included in this proxy
statement beginning on page F-20. |
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(4) |
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The amounts in the Non-Equity Incentive Plan Compensation column
reflect performance-based bonuses paid pursuant to our 2006
Corporate Bonus Plan, which is discussed further on
page 151 of this proxy statement. |
155
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(5) |
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All other compensation reported in this column includes, unless
otherwise indicated: |
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Dollar amount of
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Life insurance
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contributions made
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premiums paid by
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to Executives
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Telephone
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Name
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NxStage($)
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401(k) Plan ($)
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stipend ($)
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Jeffrey H. Burbank
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545
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8,800
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2,400
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Robert S. Brown
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75
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David N. Gill
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8,102
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2,200
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Philip R. Licari
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8,800
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840
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Winifred L. Swan
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8,561
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840
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Joseph E. Turk, Jr.
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8,800
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3,000
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(6) |
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Mr. Burbank earned an aggregate bonus of $112,505. Of this
amount, $23,923 was not paid to Mr. Burbank and was applied
against a portion of a tax
gross-up
payment made in fiscal 2004 to Mr. Burbank. |
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(7) |
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Represents the pro-rated portion of Mr. Browns base
salary of $250,000 for fiscal 2006. |
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(8) |
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This amount includes an $8,650 bonus that was guaranteed to
Mr. Brown under his employment agreement and an $82,000
signing bonus paid to Mr. Brown on the date that he joined
NxStage. Bonuses awarded pursuant to our 2006 Corporate Bonus
Plan are set forth in the Non-Equity Incentive Plan Compensation
column. |
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(9) |
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Represents the pro-rated portion of Mr. Gills base
salary paid through November 22, 2006. |
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(10) |
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As a result of Section 409A of the Internal Revenue Code,
we agreed to reprice a stock option originally granted to
Mr. Licari on October 25, 2004 for the purchase of
208,962 shares of our common stock with an exercise price
of $4.10. The repricing resulted in the cancellation and regrant
of an option to purchase 208,962 shares of our common stock
on March 24, 2006 with an exercise price of $5.47. This
option is fully vested and exercisable. In consideration for the
repriced option, we issued 13,027 shares of restricted
common stock to Mr. Licari, at a purchase price of $0.001
per share, of which 2,991 shares vested on January 1,
2007 with the remainder vesting in equal amounts on a monthly
basis commencing on January 25, 2007. Additionally, we paid
Mr. Licari $115,750 in cash on January 1, 2007 in
consideration for the repriced option. |
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(11) |
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On November 27, 2006, we increased Ms. Swans
base salary to $260,000, from $210,000. This amount reflects the
pro-rated portion of her $210,000 base salary paid through
November 27, 2006 plus the pro-rated portion of her
increased salary paid through December 31, 2006. |
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(12) |
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Mr. Turk earned an aggregate bonus of $65,583. Of this
amount, $33,097 was not paid to Mr. Turk and was applied
against a portion of a tax
gross-up
payment made in fiscal 2004 to Mr. Turk. |
156
The following table sets forth information concerning each grant
of an option or restricted stock award made to a named executive
officer during fiscal 2006 under any plan, contract,
authorization or arrangement pursuant to which cash, securities,
similar instruments or other property may be received.
GRANTS OF
PLAN-BASED AWARDS
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Target Estimated
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Option Awards:
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Future Payouts
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Number of
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Under Non-Equity
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Stock Awards:
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Securities
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Exercise
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Grant Date Fair
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Incentive Plan
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Number of
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Underlying
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Price of
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Value of Stock and
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Awards
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Shares of Stock
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Options
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Option Awards
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Option Awards
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Name
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Grant Date
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($)(1)
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(#)
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(#)
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($)
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($)(2)
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Jeffrey H. Burbank
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3/16/2006
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134,415
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Robert S. Brown
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11/27/2006
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200,000
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(3)
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8.92
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1,220,000
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David N. Gill
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3/16/2006
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87,500
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5/10/2006
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7,422
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(4)
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87,802
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Philip R. Licari
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3/16/2006
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81,113
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3/24/2006
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13,027
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(5)
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170,002
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3/24/2006
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208,962
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(5)
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5.47
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Winifred L. Swan
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3/16/2006
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78,355
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11/27/2006
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10,000
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(6)
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89,200
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Joseph E. Turk, Jr.
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3/16/2006
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73,500
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(1) |
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Reflects the target award amounts under our 2006 Corporate Bonus
Plan. The amounts actually paid to the named executive officers
under the 2006 Corporate Bonus Plan are shown above in the
Summary Compensation Table in the Non-Equity Incentive Plan
Compensation column. |
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(2) |
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Grant Date Fair Value computed in accordance with FAS 123R
and represents the FAS 123R value of the stock awarded or
option awarded as of the Grant Date. |
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(3) |
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The shares of common stock underlying this option vest as to 25%
of the shares on November 27, 2007 and in 36 equal
monthly installments over the 36 months following
November 27, 2007. |
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(4) |
|
These shares of restricted stock became fully vested on
July 31, 2006. |
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(5) |
|
As a result of Section 409A of the Internal Revenue Code,
we agreed to reprice a stock option originally granted to
Mr. Licari on October 25, 2004 for the purchase of
208,962 shares of our common stock with an exercise price
of $4.10. The repricing resulted in the cancellation and regrant
of an option to purchase 208,962 shares of our common stock
on March 24, 2006 with an exercise price of $5.47. This
option is fully vested and exercisable. In consideration for the
repriced option, we issued 13,027 shares of restricted
common stock to Mr. Licari, at a purchase price of
$0.001 per share, of which 2,991 shares vested on
January 1, 2007 with the remainder vesting in equal amounts
on a monthly basis commencing on January 25, 2007.
Additionally, we paid Mr. Licari $115,750 in cash on
January 1, 2007 in consideration for the repriced option. |
|
(6) |
|
The shares of restricted common stock underlying this award vest
in 48 equal monthly installments beginning on November 27,
2006. |
157
Information
Relating to Equity Awards and Holdings
The following table sets forth information concerning restricted
stock that has not vested, stock options that have not been
exercised and equity incentive plan awards for each of the named
executive officers outstanding as of December 31, 2006.
OUTSTANDING
EQUITY AWARDS AT FISCAL YEAR-END
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|
|
|
|
|
|
|
|
|
|
|
|
Option Awards
|
|
|
Stock Awards
|
|
|
|
Number of
|
|
|
Number of
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities
|
|
|
Securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Underlying
|
|
|
Underlying
|
|
|
|
|
|
|
|
|
Number of
|
|
|
Market
|
|
|
|
Unexercised
|
|
|
Unexercised
|
|
|
Option
|
|
|
|
|
|
Shares That
|
|
|
Value of Shares
|
|
|
|
Options
|
|
|
Options
|
|
|
Exercise
|
|
|
Option
|
|
|
Have Not
|
|
|
That Have
|
|
|
|
Exercisable
|
|
|
Unexercisable
|
|
|
Price
|
|
|
Expiration
|
|
|
Vested
|
|
|
Not Vested
|
|
Name
|
|
(#)
|
|
|
(#)
|
|
|
($)
|
|
|
Date
|
|
|
(#)
|
|
|
($)(1)
|
|
|
Jeffrey H. Burbank
|
|
|
14,146
|
(2)
|
|
|
|
|
|
|
0.34
|
|
|
|
11/1/2008
|
|
|
|
|
|
|
|
|
|
|
|
|
54,840
|
(2)
|
|
|
|
|
|
|
3.76
|
|
|
|
1/15/2011
|
|
|
|
|
|
|
|
|
|
|
|
|
54,840
|
(2)
|
|
|
|
|
|
|
3.76
|
|
|
|
8/22/2011
|
|
|
|
|
|
|
|
|
|
|
|
|
36,560
|
(2)
|
|
|
|
|
|
|
4.10
|
|
|
|
3/7/2012
|
|
|
|
|
|
|
|
|
|
|
|
|
36,560
|
(2)
|
|
|
|
|
|
|
4.10
|
|
|
|
2/4/2013
|
|
|
|
|
|
|
|
|
|
|
|
|
44,603
|
(2)
|
|
|
|
|
|
|
5.47
|
|
|
|
2/13/2014
|
|
|
|
|
|
|
|
|
|
|
|
|
73,120
|
(2)
|
|
|
|
|
|
|
6.84
|
|
|
|
1/20/2015
|
|
|
|
|
|
|
|
|
|
|
|
|
36,560
|
(3)
|
|
|
109,680
|
|
|
|
8.55
|
|
|
|
9/15/2012
|
|
|
|
|
|
|
|
|
|
Robert S. Brown
|
|
|
|
|
|
|
200,000
|
(4)
|
|
|
8.92
|
|
|
|
11/27/2013
|
|
|
|
|
|
|
|
|
|
David N. Gill
|
|
|
69,463
|
(5)
|
|
|
|
|
|
|
8.55
|
|
|
|
5/21/2007
|
|
|
|
|
|
|
|
|
|
|
|
|
20,000
|
(5)
|
|
|
|
|
|
|
12.59
|
|
|
|
5/21/2007
|
|
|
|
|
|
|
|
|
|
Philip R. Licari
|
|
|
208,962
|
(6)
|
|
|
|
|
|
|
5.47
|
|
|
|
10/24/2014
|
|
|
|
13,027
|
(6)
|
|
|
109,166
|
|
Winifred L. Swan
|
|
|
25,555
|
(2)
|
|
|
|
|
|
|
2.74
|
|
|
|
11/27/2010
|
|
|
|
9,792
|
|
|
|
82,057
|
|
|
|
|
3,656
|
(2)
|
|
|
|
|
|
|
3.76
|
|
|
|
8/22/2011
|
|
|
|
|
|
|
|
|
|
|
|
|
20,839
|
(2)
|
|
|
|
|
|
|
4.10
|
|
|
|
3/7/2012
|
|
|
|
|
|
|
|
|
|
|
|
|
7,494
|
(2)
|
|
|
|
|
|
|
4.10
|
|
|
|
2/4/2013
|
|
|
|
|
|
|
|
|
|
|
|
|
6,997
|
(2)
|
|
|
|
|
|
|
5.47
|
|
|
|
2/13/2014
|
|
|
|
|
|
|
|
|
|
|
|
|
10,968
|
(2)
|
|
|
|
|
|
|
6.84
|
|
|
|
1/20/2015
|
|
|
|
|
|
|
|
|
|
|
|
|
11,425
|
(7)
|
|
|
25,135
|
|
|
|
8.55
|
|
|
|
9/15/2012
|
|
|
|
|
|
|
|
|
|
Joseph E. Turk, Jr
|
|
|
3,656
|
(2)
|
|
|
|
|
|
|
3.76
|
|
|
|
1/15/2011
|
|
|
|
|
|
|
|
|
|
|
|
|
7,312
|
(2)
|
|
|
|
|
|
|
3.76
|
|
|
|
8/22/2011
|
|
|
|
|
|
|
|
|
|
|
|
|
12,613
|
(2)
|
|
|
|
|
|
|
4.10
|
|
|
|
3/7/2012
|
|
|
|
|
|
|
|
|
|
|
|
|
14,989
|
(2)
|
|
|
|
|
|
|
4.10
|
|
|
|
2/4/2013
|
|
|
|
|
|
|
|
|
|
|
|
|
13,986
|
(2)
|
|
|
|
|
|
|
5.47
|
|
|
|
2/13/2014
|
|
|
|
|
|
|
|
|
|
|
|
|
29,248
|
(2)
|
|
|
|
|
|
|
6.84
|
|
|
|
1/20/2015
|
|
|
|
|
|
|
|
|
|
|
|
|
6,855
|
(7)
|
|
|
15,081
|
|
|
|
8.55
|
|
|
|
9/15/2012
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Based on $8.38 per share, the last sale price of NxStage
common stock on December 29, 2006. |
|
(2) |
|
These options were fully exercisable on the date of grant and,
upon exercise, were subject to a repurchase right in favor of
NxStage. This repurchase right terminated upon the closing of
our initial public offering and all such options are currently
exercisable. |
|
(3) |
|
This option was granted on September 15, 2005. This option
vested as to 20% of the shares on September 15, 2006 and
will vest in equal monthly installments over the next
48 months following September 15, 2006. |
|
(4) |
|
This option was granted on November 27, 2006. This option
will vest as to 25% of the shares on November 27, 2007 and
in equal monthly installments over the next 36 months
following November 27, 2007. |
|
(5) |
|
Pursuant to his employment agreement, Mr. Gill has been
allowed 180 days subsequent to the date his employment was
terminated, November 22, 2006, to exercise his stock
options that had vested as of |
158
|
|
|
|
|
November 22, 2006. At November 22, 2006, he was vested
in 89,463 shares that are exercisable through May 21,
2007. |
|
(6) |
|
As a result of Section 409A of the Internal Revenue Code,
we agreed to reprice a stock option originally granted to
Mr. Licari on October 25, 2004 for the purchase of
208,962 shares of our common stock with an exercise price
of $4.10. The repricing resulted in the cancellation and regrant
of an option to purchase 208,962 shares of our common stock
on March 24, 2006 with an exercise price of $5.47. This
option is fully vested and exercisable. In consideration for the
repriced option, we issued 13,027 shares of restricted
common stock to Mr. Licari, at a purchase price of $0.001
per share, of which 2,991 shares vested on January 1,
2007 with the remainder vesting in equal amounts on a monthly
basis commencing on January 25, 2007. Additionally, we paid
Mr. Licari $115,750 in cash on January 1, 2007 in
consideration for the repriced option. |
|
(7) |
|
These options were granted on September 15, 2005. This
option vested as to 25% of the shares on September 15, 2006
and will vest in equal monthly installments over the
36 months following September 15, 2006. |
The following table sets forth information concerning the
exercise of stock options and the vesting of restricted stock
during fiscal 2006 for each of the named executive officers.
OPTION
EXERCISES AND STOCK VESTED
|
|
|
|
|
|
|
|
|
|
|
Stock Awards
|
|
|
|
Number of Shares
|
|
|
Value Realized
|
|
|
|
Acquired on Vesting
|
|
|
on Vesting
|
|
Name
|
|
(#)
|
|
|
($)(1)
|
|
|
Jeffrey H. Burbank
|
|
|
|
|
|
|
|
|
Robert S. Brown
|
|
|
|
|
|
|
|
|
David N. Gill
|
|
|
7,422
|
|
|
|
63,607
|
|
Philip R. Licari
|
|
|
|
|
|
|
|
|
Winifred L. Swan
|
|
|
208
|
|
|
|
1,820
|
|
Joseph E. Turk, Jr.
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Value realized upon vesting is based on the closing sales price
of our common stock on the applicable vesting date. |
Employment
Agreements with Named Executive Officers
We have entered into employment agreements with each of our
named executive officers, the terms of which are summarized
below.
Jeffrey H. Burbank. Pursuant to the terms of
his employment agreement, Mr. Burbank is entitled to
receive an annual base salary of $290,000. For 2006, we paid
Mr. Burbank an annual base salary of $298,700 and a cash
bonus of $112,505, $23,923 of which was not paid to
Mr. Burbank pursuant to a board of directors action
requiring that bonuses earned between 2004 and 2006 be offset
against a portion of the tax
gross-up
paid to Mr. Burbank in connection with the forgiveness of
all of his indebtedness to NxStage in 2004. On April 9,
2007, our compensation committee approved an increase in
Mr. Burbanks annual base salary to $330,000,
effective January 1, 2007, and established a target cash
bonus equal to 50% of his base salary pursuant to our 2007
Corporate Bonus Plan, or 2007 Plan. If, before a change in
control of NxStage, as defined in his employment agreement, we
terminate Mr. Burbanks employment without cause or he
resigns for good reason, each as defined in his employment
agreement, then Mr. Burbank will be entitled to receive:
|
|
|
|
|
severance payments in an amount equal to his then-current base
salary, which will be paid over the 12 months following
termination of his employment;
|
|
|
|
continued medical coverage during the 12 months following
termination of his employment; and
|
159
|
|
|
|
|
continued vesting during the 12 months following
termination of his employment in all stock options and stock
awards he holds at the time his employment is terminated as if
he continued to be employed during such period, and, except as
described below, he will have up to 90 days following the
expiration of such period to exercise such options.
|
If, following a change in control, (i) we terminate
Mr. Burbanks employment, or (ii) we had
terminated Mr. Burbanks employment at any time three
months prior to announcement of the change in control and we
cannot reasonably demonstrate that such termination did not
arise in connection with such change in control, or if
Mr. Burbank resigns for good reason within 12 months
following a change in control, then he will be entitled to:
|
|
|
|
|
a lump sum severance payment equal to two times his then-current
base salary and two times the greater of his annual bonus for
the fiscal year preceding his termination or his target bonus
for the then-current fiscal year;
|
|
|
|
continue to receive medical coverage during the 24 months
following termination of his employment;
|
|
|
|
full vesting and acceleration of stock options and stock awards
he holds at the time his employment is terminated and a period
of 90 days to exercise such stock options; and
|
|
|
|
receive
gross-up
amount on benefits received under this agreement to compensate
for excise taxes and associated penalties imposed by
Section 4999 of the Internal Revenue Code of 1986, as
amended.
|
Robert S. Brown. Pursuant to the terms of his
employment agreement, Mr. Brown is entitled to receive an
annual base salary of $250,000. For 2006, we paid Mr. Brown
the pro-rated portion of his base salary, or $24,639, a cash
bonus of $8,650 and a one-time signing bonus of $82,000.
Additionally, pursuant to his employment agreement, on
November 27, 2006 we granted Mr. Brown an incentive
stock option to purchase 200,000 shares of our common
stock, with an exercise price of $8.92 per share.
Mr. Browns base salary remains unchanged for 2007.
Effective April 9, 2007, our compensation committee
established a target cash bonus equal to 35% of
Mr. Browns base salary pursuant to our 2007 Plan. If,
before a change in control of NxStage, we terminate
Mr. Browns employment without cause or he resigns for
good reason, each as defined in his employment agreement, then
Mr. Brown will be entitled to receive:
|
|
|
|
|
severance payments in an amount equal to 0.5 times his
then-current base salary, which will be paid over the six months
following termination of his employment;
|
|
|
|
continued medical coverage during the six months following
termination of his employment; and
|
|
|
|
continued vesting during the six months following termination of
his employment in all stock options and stock awards he holds at
the time his employment is terminated as if he continued to be
employed during such period, and, except as described below, he
will have up to 90 days following the expiration of such
period to exercise such options.
|
If, following a change in control, (i) we terminate
Mr. Browns employment, or (ii) we have
terminated Mr. Browns employment at any time three
months prior to announcement of the change in control, and we
cannot reasonably demonstrate that such termination did not
arise in connection with such change in control, or if
Mr. Brown resigns for good reason within 12 months
following a change in control, then he will be entitled to:
|
|
|
|
|
a lump severance payment equal to his then-current base salary
and the greater of his annual bonus for the fiscal year
preceding his termination or his target bonus for the
then-current fiscal year;
|
|
|
|
continued medical coverage during the 12 months following
termination of his employment;
|
|
|
|
full vesting and acceleration of stock options and stock awards
he holds at the time his employment is terminated and a period
of 90 days to exercise such stock options; and
|
|
|
|
receive
gross-up
amount on benefits received under this agreement to compensate
for excise taxes and associated penalties imposed by
Section 4999 of the Internal Revenue Code of 1986, as
amended.
|
160
Philip R. Licari. Pursuant to the terms of his
employment agreement, Mr. Licari is entitled to receive an
annual base salary of $225,000. For 2006, we paid
Mr. Licari an annual base salary of $231,750 and a cash
bonus of $54,313. On April 9, 2007, our compensation
committee set Mr. Licaris base salary for 2007 at
$240,000, effective January 1, 2007, and established a
target cash bonus equal to 35% of his base salary pursuant to
our 2007 Plan. If, before a change in control of NxStage, as
defined in his employment agreement, we terminate
Mr. Licaris employment without cause or he resigns
for good reason, each as defined in his employment agreement,
then Mr. Licari will be entitled to receive:
|
|
|
|
|
severance payments in an amount equal to 0.5 times his
then-current base salary, which will be paid over the six months
following termination of his employment;
|
|
|
|
continued medical coverage during the six months following
termination of his employment; and
|
|
|
|
continued vesting during the six months following termination of
his employment in all stock options and stock awards he holds at
the time his employment is terminated as if he continued to be
employed during such period, and, except as described below,
will have up to 90 days following the expiration of such
period to exercise such options.
|
If, following a change in control, (i) we terminate
Mr. Licaris employment, or (ii) we had
terminated Mr. Licaris employment at any time three
months prior to announcement of the change in control and we
cannot reasonably demonstrate that such termination did not
arise in connection with such change in control, or if
Mr. Licari resigns for good reason within 12 months
following a change in control, then he will be entitled to:
|
|
|
|
|
a lump sum severance payment equal to his then-current base
salary and the greater of his annual bonus for the fiscal year
preceding his termination or his target bonus for the
then-current fiscal year;
|
|
|
|
continued medical coverage during the 12 months following
termination of his employment;
|
|
|
|
full vesting and acceleration of stock options and stock awards
he holds at the time his employment is terminated and a period
of 90 days to exercise such stock options; and
|
|
|
|
receive
gross-up
amount on benefits received under this agreement to compensate
for excise taxes and associated penalties imposed by
Section 4999 of the Internal Revenue Code of 1986, as
amended.
|
On August 28, 2007, we announced that Mr. Licari plans to
resign from NxStage effective upon the completion of the Stock
Purchase.
Joseph E. Turk. Pursuant to the terms of his
employment agreement, Mr. Turk is entitled to receive an
annual base salary of $217,350. For 2006, we paid Mr. Turk
an annual base salary of $223,871 and a cash bonus of $65,583,
$33,097 of which was not paid to Mr. Turk pursuant to a
board of directors action requiring that bonuses earned between
2004 and 2006 be offset against a portion of the tax
gross-up
paid to Mr. Turk in connection with the forgiveness of all
of his indebtedness to NxStage in 2004. On April 9, 2007,
our compensation committee set Mr. Turks base salary
for 2007 at $260,000, effective January 1, 2007, and
established a target cash bonus equal to 45% of his base salary
pursuant to our 2007 Plan. If, before a change in control of
NxStage, as defined in his employment agreement, we terminate
Mr. Turks employment without cause or he resigns for
good reason, each as defined in his employment agreement, then
Mr. Turk will be entitled to receive:
|
|
|
|
|
severance payments in an amount equal to 0.5 times his
then-current base salary, which will be paid over the six months
following termination of his employment;
|
|
|
|
continued medical coverage during the six months following
termination of his employment; and
|
|
|
|
continued vesting during the six months following termination of
his employment in all stock options and stock awards he holds at
the time his employment is terminated as if he continued to be
employed during such period, and, except as described below,
will have up to 90 days following the expiration of such
period to exercise such options.
|
161
If, following a change in control, (i) we terminate
Mr. Turks employment, or (ii) we had terminated
Mr. Turks employment at any time three months prior
to announcement of the change in control and we cannot
reasonably demonstrate that such termination did not arise in
connection with such change in control, or if Mr. Turk
resigns for good reason within 12 months following a change
in control, then he will be entitled to:
|
|
|
|
|
a lump sum severance payment equal to his then-current base
salary and the greater of his annual bonus for the fiscal year
preceding his termination or his target bonus for the
then-current fiscal year;
|
|
|
|
continue to receive medical coverage during the 12 months
following termination of his employment;
|
|
|
|
full vesting and acceleration of stock options and stock awards
he holds at the time his employment is terminated and a period
of 90 days to exercise such stock options; and
|
|
|
|
receive
gross-up
amount on benefits received under this agreement to compensate
for excise taxes and associated penalties imposed by
Section 4999 of the Internal Revenue Code of 1986, as
amended.
|
Winifred L Swan. Pursuant to the terms of her
employment agreement, Ms. Swan is entitled to receive an
annual base salary of $203,000. For 2006, we paid Ms. Swan
an annual base salary of $210,000 through November 27,
2006, and we increased her base salary to $260,000 effective
November 27, 2006. For 2006, we paid Ms. Swan a cash
bonus of $63,576. Ms. Swans base salary remains
unchanged for 2007. Effective April 9, 2007, our
compensation committee established a target cash bonus equal to
35% of Ms. Swans base salary pursuant to our 2007
Plan. If, before a change in control of NxStage, as defined in
her employment agreement, we terminate Ms. Swans
employment without cause or she resigns for good reason, each as
defined in her employment agreement, then Ms. Swan will be
entitled to receive:
|
|
|
|
|
severance payments in an amount equal to 0.5 times her
then-current base salary, which will be paid over the six months
following termination of her employment;
|
|
|
|
continued medical coverage during the six months following
termination of her employment; and
|
|
|
|
continued vesting during the six months following termination of
her employment in all stock options and stock awards she holds
at the time her employment is terminated as if she continued to
be employed during such period, and, except as described below,
will have up to 90 days following the expiration of such
period to exercise such options.
|
If, following a change in control, (i) we terminate
Ms. Swans employment, or (ii) we had terminated
Ms. Swans employment at any time three months prior
to announcement of the change in control and we cannot
reasonably demonstrate that such termination did not arise in
connection with such change in control, or if Ms. Swan
resigns for good reason within 12 months following a change
in control, then she will be entitled to:
|
|
|
|
|
a lump sum severance payment equal to 1.25 times her
then-current base salary and 1.25 times the greater of her
annual bonus for the fiscal year preceding her termination or
her target bonus for the then-current fiscal year;
|
|
|
|
continue to receive medical coverage during the 15 months
following termination of her employment; and
|
|
|
|
full vesting and acceleration of stock options and stock awards
she holds at the time her employment is terminated and a period
of 90 days to exercise such stock options.
|
In addition to the terms set forth above, the executive
officers employment agreements also provide that each
executive officer is entitled to:
|
|
|
|
|
participate in short-term and long-term incentive programs,
which incentive compensation will be subject to the terms of the
applicable plans and paid on the basis of the executive
officers individual performance, as determined by our
board of directors or Compensation Committee.
|
162
|
|
|
|
|
receive retirement and welfare benefits that we make available
from time to time to our senior level executives;
|
|
|
|
receive a
gross-up
amount on benefits received under this agreement to compensate
for excise taxes and associated penalties imposed by
Section 4999 of the Internal Revenue Code of 1986, as
amended.
|
If the executive officer terminates employment with NxStage
voluntarily, other than for good reason, if we terminate the
executive officers employment as a result of physical or
mental disability or for cause, each as defined in the
agreement, or if the executive officer dies, the executive
officer will receive compensation and benefits through the last
day of employment.
David N. Gill. Mr. Gill resigned as our
Vice President, Chief Financial Officer, Principal Financial
Officer and Principal Accounting Officer on November 22,
2006. Pursuant to his employment agreement with us, we paid
Mr. Gill a pro-rated base salary of $294,120 through the
date of his resignation. No additional amounts were paid to
Mr. Gill pursuant to his employment agreement during fiscal
2006, and no severance or separation payments were paid (and are
not owed) to Mr. Gill following his resignation. Pursuant
to his employment agreement, Mr. Gills vested stock
options as of November 22, 2006 will remain exercisable
through May 21, 2007.
Each of Messrs. Burbank, Brown, Gill, Licari, Turk and
Ms. Swan have signed agreements providing for the
protection of our confidential information and the transfer of
ownership rights to intellectual property developed by such
executive officer while he or she was employed by us. If the
executive officer fails to comply with the provisions of the
proprietary information agreement between NxStage and the
executive officer, the payments and benefits described above
will cease.
163
Potential
Termination and Change in Control Payments
The following table describes the potential payments, benefits
and acceleration of vesting applicable to stock options and
restricted stock awards pursuant to employment agreements with
each of Messrs. Burbank, Brown, Licari and Turk and
Ms. Swan. The amounts shown below assume that the
termination of each executive is effective as of
December 31, 2006. Actual amounts payable to each executive
listed below upon his or her termination can only be determined
definitively at the time of each executives actual
departure. In addition to the amounts shown in the table below,
each executive would receive payments for amounts of base salary
and vacation time accrued through the date of termination. For
information relating to compensation earned by each of our named
executive officers, see Summary Compensation
Table.
|
|
|
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|
|
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|
|
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|
|
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|
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|
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Termination
|
|
|
|
|
|
|
|
|
Without Cause
|
|
|
|
|
|
|
|
|
Three Months Prior to
|
|
|
|
|
|
|
|
|
Change in Control;
|
|
|
|
|
|
|
|
|
Termination
|
|
|
|
|
|
|
|
|
Without Cause
|
|
|
|
|
|
|
|
|
at Any Time After a
|
|
|
|
|
|
|
|
|
Change in Control;
|
|
|
|
|
|
|
|
|
Resignation for
|
|
|
|
|
|
Termination
|
|
|
Good Reason
|
|
|
|
|
|
Without Cause
|
|
|
During the 12 Months
|
|
|
|
|
|
or Resignation
|
|
|
Following a Change
|
|
|
|
|
|
for Good Reason
|
|
|
in Control
|
|
Name
|
|
Benefit
|
|
($)
|
|
|
($)
|
|
|
Jeffrey H. Burbank
|
|
Severance Benefits
|
|
|
|
|
|
|
|
|
|
|
Severance Payments
|
|
|
298,700
|
(3)
|
|
|
822,410
|
(6)
|
|
|
Healthcare Benefits(1)
|
|
|
11,903
|
(4)
|
|
|
23,806
|
(7)
|
|
|
Market Value of Stock Vesting on
Termination(2)
|
|
|
|
(5)
|
|
|
|
(8)
|
|
|
Tax Gross Up
|
|
|
N/A
|
|
|
|
114,613
|
|
|
|
Total
|
|
|
310,603
|
|
|
|
960,829
|
|
Robert S. Brown
|
|
Severance Benefits
|
|
|
|
|
|
|
|
|
|
|
Severance Payments
|
|
|
125,000
|
(9)
|
|
|
258,650
|
(12)
|
|
|
Healthcare Benefits(1)
|
|
|
5,951
|
(10)
|
|
|
11,903
|
(13)
|
|
|
Market Value of Stock Vesting on
Termination(2)
|
|
|
|
(11)
|
|
|
|
(8)
|
|
|
Tax Gross Up
|
|
|
N/A
|
|
|
|
49,183
|
|
|
|
Total
|
|
|
130,951
|
|
|
|
319,736
|
|
Philip R. Licari
|
|
Severance Benefits
|
|
|
|
|
|
|
|
|
|
|
Severance Payments
|
|
|
115,875
|
(9)
|
|
|
286,063
|
(12)
|
|
|
Healthcare Benefits(1)
|
|
|
5,951
|
(10)
|
|
|
11,903
|
(13)
|
|
|
Market Value of Stock Vesting on
Termination(2)
|
|
|
16,677
|
(11)
|
|
|
109,166
|
(8)
|
|
|
Tax Gross Up
|
|
|
N/A
|
|
|
|
48,188
|
|
|
|
Total
|
|
|
138,503
|
|
|
|
455,320
|
|
Joseph E. Turk
|
|
Severance Benefits
|
|
|
|
|
|
|
|
|
|
|
Severance Payments
|
|
|
111,936
|
(9)
|
|
|
289,454
|
(12)
|
|
|
Healthcare Benefits(1)
|
|
|
5,951
|
(10)
|
|
|
11,903
|
(13)
|
|
|
Market Value of Stock Vesting on
Termination(2)
|
|
|
|
(11)
|
|
|
|
(8)
|
|
|
Tax Gross Up
|
|
|
N/A
|
|
|
|
17,129
|
|
|
|
Total
|
|
|
117,887
|
|
|
|
318,486
|
|
Winifred L. Swan
|
|
Severance Benefits
|
|
|
|
|
|
|
|
|
|
|
Severance Payments
|
|
|
130,000
|
(9)
|
|
|
404,470
|
(14)
|
|
|
Healthcare Benefits(1)
|
|
|
5,472
|
(10)
|
|
|
13,681
|
(15)
|
|
|
Market Value of Stock Vesting on
Termination(2)
|
|
|
|
(11)
|
|
|
|
(8)
|
|
|
Tax Gross Up
|
|
|
N/A
|
|
|
|
43,847
|
|
|
|
Total
|
|
|
135,472
|
|
|
|
461,998
|
|
|
|
|
(1) |
|
This value is based upon the type of insurance coverage we
carried for each executive officer as of December 31, 2006
and is valued at the premiums in effect on December 31,
2006. |
|
(2) |
|
Based on the last sale price of our common stock on
December 29, 2006, or $8.38 per share. |
|
(3) |
|
Represents aggregate severance payments equal to
Mr. Burbanks base salary at the time of his
termination, payable over the
12-month
period following his termination. |
164
|
|
|
(4) |
|
Represents amounts payable over 12 months for continuation
of coverage under medical and dental plans for Mr. Burbank,
his spouse and his dependents. |
|
(5) |
|
Represents continued vesting of Mr. Burbanks stock
options and stock awards through December 31, 2007. |
|
(6) |
|
Represents a lump sum payment equal to two times
Mr. Burbanks base salary at the time of his
termination plus an amount equal to two times the annual bonus
paid to Mr. Burbank during fiscal 2006. |
|
(7) |
|
Represents amounts payable over 24 months for continuation
of coverage under medical and dental plans for Mr. Burbank. |
|
(8) |
|
Represents immediate vesting of all unvested stock options and
other stock awards held by the executive as of December 31,
2006. |
|
(9) |
|
Represents aggregate severance payments in an amount equal to
0.5 times the executives then current base salary at the
time of his or her termination, payable over the following six
months. |
|
(10) |
|
Represents amounts payable over six months for continuation of
coverage under medical and dental plans for the executive. |
|
(11) |
|
Represents continued vesting of the executives stock
options and stock awards for six months following termination. |
|
(12) |
|
Represents a lump sum payment equal to the executives then
current base salary at the time of his or her termination plus
an amount equal to the annual bonus paid to the executive during
fiscal 2006. |
|
(13) |
|
Represents amounts payable over 12 months for continuation
of coverage under medical and dental plans for the executive. |
|
(14) |
|
Represents a lump sum payment equal to 1.25 times
Ms. Swans then current base salary at the time of her
termination plus an amount equal to 1.25 times the annual bonus
paid to Ms. Swan during fiscal 2006. |
|
(15) |
|
Represents amounts payable over 15 months for continuation
of coverage under medical and dental plans for Ms. Swan. |
Securities
Authorized for Issuance Under Our Equity Compensation
Plan
The following table provides information about the securities
authorized for issuance under our equity compensation plans as
of December 31, 2006.
Equity
Compensation Plan Information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
|
|
|
|
|
securities
|
|
|
|
|
|
|
remaining available
|
|
|
|
|
|
|
for future issuance
|
|
|
|
|
|
|
under equity
|
|
|
Number of
|
|
|
|
compensation plans
|
|
|
securities to be
|
|
|
|
(excluding
|
|
|
issued upon
|
|
Weighted-average
|
|
securities
|
|
|
exercise of
|
|
exercise price of
|
|
reflected in column
|
|
|
outstanding options
|
|
outstanding options
|
|
(a)
|
Plan Category
|
|
(a)(1)
|
|
(b)
|
|
(c)(1)
|
|
Equity compensation plans approved
by security holders
|
|
|
3,141,890
|
|
|
$
|
7.03
|
|
|
|
132,363
|
|
|
|
|
(1) |
|
Includes information regarding the following
stockholder-approved equity compensation plans: (i) 2005
plan and (ii) 2005 employee stock purchase plan. The number
of shares available for grant under the 2005 Plan increased in
January 2007 by 600,000 shares. We have no equity
compensation plans that are not approved by security holders. |
165
Director
Compensation
Under our non-employee director compensation policy, last
amended in March 2006, our non-employee directors receive:
|
|
|
|
|
a $15,000 annual retainer for their service as directors, to be
paid quarterly in advance;
|
|
|
|
$2,500 for each board meeting attended by the director in
person, $1,000 for each board meeting attended by telephone and
$1,000 for each committee meeting attended where the committee
meeting is scheduled on a date other than a board meeting;
|
|
|
|
if he or she is a member of the Audit Committee, an additional
annual retainer of $6,000 (or $10,000 for the Audit Committee
chair), paid quarterly in advance;
|
|
|
|
if he or she is a member of any committee other than the Audit
Committee, an additional annual retainer of $4,000 for each
other committee, paid quarterly in advance;
|
|
|
|
expense reimbursement for attending board of directors and
committee meetings; and
|
|
|
|
on the date of our annual meeting of stockholders at which a
non-employee director is elected, a fully vested stock option to
purchase 14,000 shares of our common stock with an exercise
price equal to the then fair market value of our common stock,
as determined by the closing price of our common stock on the
date of the annual meeting. For a director elected or otherwise
appointed to the board of directors on a date other than the
date of an annual meeting of stockholders, such director will
receive a fully vested stock option to purchase
14,000 shares of our common stock pro-rated for the period
between the date he or she is first elected to the board of
directors and May 31 of the year in which such director is
elected or appointed to our board of directors.
|
No director shall receive more than $50,000 in any calendar year
for board fees, without the prior approval of the Compensation
Committee.
In March 2006, our board of directors amended our non-employee
director compensation policy so that directors may elect to
receive shares of our common stock in lieu of the cash
compensation described above. A director must make his election
to receive equity in lieu of cash compensation on the date of
the annual meeting of stockholders at which such director is
elected. A directors election to receive equity in lieu of
cash compensation will apply to all compensation to be paid
after the date of election and will remain in effect until the
next annual meeting of stockholders. If a non-employee director
elects to receive equity in lieu of cash, we will issue the
director shares of our common stock on the last business day of
each calendar quarter in an amount equal to the quotient of the
total cash consideration due as of the last business day of each
calendar quarter and the closing price of our common stock on
the last trading day of that quarter. Each of Dr. Chambon
and Messrs. Perper, Utterberg and Moore has elected to
receive shares of common stock in lieu of cash compensation for
their service on our board of directors. All shares of our
common stock issued to our directors in lieu of cash are issued
under our 2005 Plan.
We do not compensate directors who are also employees for their
services as directors.
166
The following table sets forth information concerning the
compensation of our directors who are not also named executive
officers for the fiscal year ended December 31, 2006.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fees Earned or
|
|
Stock
|
|
|
|
|
|
|
Paid in Cash
|
|
Awards
|
|
Option Awards
|
|
Total
|
Name
|
|
($)(1)
|
|
($)(2)
|
|
($)(3)(4)
|
|
($)
|
|
Philippe O. Chambon
|
|
|
|
|
|
|
33,000
|
|
|
|
60,678
|
|
|
|
93,678
|
|
Daniel A. Giannini
|
|
|
60,750
|
|
|
|
|
|
|
|
60,678
|
|
|
|
121,428
|
|
Reid S. Perper
|
|
|
7,000
|
|
|
|
25,000
|
|
|
|
60,678
|
|
|
|
92,678
|
|
David S. Utterberg
|
|
|
19,750
|
|
|
|
20,000
|
|
|
|
60,678
|
|
|
|
100,428
|
|
Peter P. Phildius
|
|
|
58,250
|
|
|
|
|
|
|
|
60,678
|
|
|
|
118,928
|
|
Craig W. Moore
|
|
|
35,250
|
|
|
|
33,000
|
|
|
|
60,678
|
|
|
|
128,928
|
|
|
|
|
(1) |
|
The fees earned by our non-employee directors in fiscal 2006
consist of the following: (i) an annual retainer,
(ii) $2,500 for each board meeting attended by the director
in person, $1,000 for each board meeting attended by telephone
and $1,000 for each committee meeting attended where the
committee meeting is scheduled on a date other than a board
meeting date, and (iii) an annual fee for chairing and
being a member of each of the audit, compensation and nominating
and corporate governance committees. See footnote 2 below
for shares of common stock issued in lieu of this cash
compensation to certain of our directors. |
|
(2) |
|
The amounts in the Stock Awards column reflect the dollar amount
recognized as compensation cost for financial statement
reporting purposes for the fiscal year ended December 31,
2006 in accordance with FAS 123R. These shares were issued
pursuant to our non-employee director compensation policy, as
amended in March 2006, in connection with the election by each
of Messrs. Chambon, Perper, Utterberg and Moore to receive
shares of our common stock in lieu of cash compensation during
fiscal 2006. Accordingly, we issued shares of our common stock
to each of these directors as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Cash
|
|
Closing
|
|
|
|
|
|
|
|
|
Consideration
|
|
Price of
|
|
|
|
Total Shares of
|
|
|
|
|
Due as of
|
|
Common Stock
|
|
|
|
Common Stock
|
|
|
|
|
Last Business
|
|
on Last Trading
|
|
|
|
Issued In Lieu of
|
|
|
|
|
Day of Quarter
|
|
Day of Quarter
|
|
Equity
|
|
Cash Consideration
|
Name
|
|
Quarter Ending
|
|
($)
|
|
($)
|
|
Issuance Date
|
|
(#)
|
|
Philippe O. Chambon
|
|
|
6/30/2006
|
|
|
|
3,500
|
|
|
|
8.73
|
|
|
|
6/30/2006
|
|
|
|
400
|
|
|
|
|
9/30/2006
|
|
|
|
11,750
|
|
|
|
8.77
|
|
|
|
9/30/2006
|
|
|
|
1,339
|
|
|
|
|
12/31/2006
|
|
|
|
17,750
|
|
|
|
8.38
|
|
|
|
12/29/2006
|
|
|
|
2,118
|
|
Reid S. Perper
|
|
|
6/30/2006
|
|
|
|
1,000
|
|
|
|
8.73
|
|
|
|
6/30/2006
|
|
|
|
114
|
|
|
|
|
9/30/2006
|
|
|
|
8,750
|
|
|
|
8.77
|
|
|
|
9/30/2006
|
|
|
|
997
|
|
|
|
|
12/31/2006
|
|
|
|
15,250
|
|
|
|
8.38
|
|
|
|
12/29/2006
|
|
|
|
1,819
|
|
David S. Utterberg
|
|
|
6/30/2006
|
|
|
|
|
|
|
|
8.73
|
|
|
|
6/30/2006
|
|
|
|
|
|
|
|
|
9/30/2006
|
|
|
|
8,750
|
|
|
|
8.77
|
|
|
|
9/30/2006
|
|
|
|
997
|
|
|
|
|
12/31/2006
|
|
|
|
11,250
|
|
|
|
8.38
|
|
|
|
12/29/2006
|
|
|
|
1,342
|
|
Craig W. Moore
|
|
|
6/30/2006
|
|
|
|
2,500
|
|
|
|
8.73
|
|
|
|
6/30/2006
|
|
|
|
286
|
|
|
|
|
9/30/2006
|
|
|
|
12,250
|
|
|
|
8.77
|
|
|
|
9/30/2006
|
|
|
|
1,396
|
|
|
|
|
12/31/2006
|
|
|
|
18,250
|
|
|
|
8.38
|
|
|
|
12/29/2006
|
|
|
|
2,177
|
|
|
|
|
(3) |
|
The amounts in the Option Awards column reflect the dollar
amount recognized as compensation cost for financial statement
reporting purposes for the fiscal year ended December 31,
2006, in accordance with FAS 123R of stock options granted
under our equity plans and may include amounts from stock
options granted in and prior to 2006. There can be no assurance
that the FAS 123R amounts will ever be realized. The
assumptions we used to calculate these amounts are included in
the footnotes to our audited financial statements for the fiscal
year ended December 31, 2006 included in the proxy
statement on
page F-20. |
167
|
|
|
(4) |
|
On May 30, 2006, the day of our 2006 annual meeting of
stockholders, we granted each of our non-employee directors an
option to purchase 14,000 shares of our common stock, each
with an exercise price equal to $10.83 per share, the closing
price of our common stock on the date of the 2006 annual
meeting. All such options were immediately exercisable on the
date of grant. |
Compensation
Committee Interlocks and Insider Participation
The current members of the Compensation Committee are
Messrs. Phildius and Moore and Dr. Chambon. No member
of the Compensation Committee was at any time during fiscal
2006, or formerly, an officer or employee of ours or any
subsidiary of ours, nor has any member of the Compensation
Committee had any relationship with us requiring disclosure
under Item 404 of
Regulation S-K
under the Securities Exchange Act of 1934, as amended.
No executive officer of NxStage has served as a director or
member of the compensation committee (or other committee serving
an equivalent function) of any other entity, one of whose
executive officers served as a director of or member of our
Compensation Committee.
Compensation
Committee Report
The Compensation Committee has reviewed and discussed the
section of this proxy statement entitled Compensation
Committee Discussion and Analysis with management. Based
on this review and discussion, the Compensation Committee has
recommended to the Board of Directors that such section be
included in this proxy statement.
By the Compensation Committee of the Board of Directors
Craig W. Moore (Chair)
Philippe O. Chambon
Peter P. Phildius
NxSTAGE
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Mr. Utterberg, who is a director of NxStage and currently
owns approximately 6.7% of our outstanding common stock based on
the number of shares of our common stock outstanding as of
July 31, 2007, owns, directly or indirectly, all of the
equity interests that we are purchasing in the MDS Entities.
Accordingly, Mr. Utterberg will receive
6,500,000 shares of our common stock, subject to a
post-closing working capital adjustment, if the Stock Purchase
is approved and completed. As of June 4, 2007 the aggregate
market value of the 6,500,000 shares of common stock
issuable to Mr. Utterberg was $78.7 million, based on
a per share price of $12.11, the last sales price of our common
stock on the NASDAQ Global market on that date.
Additionally, in connection with the Stock Purchase we will
enter into a consulting agreement with Mr. Utterberg. Under
the consulting agreement, Mr. Utterberg will receive
aggregate payments from us of $200,000 per year, plus expenses,
for two years. The terms of the consulting agreement are more
fully detailed in this proxy statement under the heading
License Agreement and Consulting Agreement beginning
on page 75.
Following the Stock Purchase, Mr. Utterberg will continue
to serve on our board of directors. In addition, the stock
purchase agreement provides that, if Mr. Utterberg is no
longer a director of NxStage, our board of directors will
nominate for election to our board any director nominee proposed
by Mr. Utterberg, subject to certain conditions.
168
Pursuant to our policies and procedures concerning related
person transactions, which are described below, our Audit
Committee reviewed and approved the Stock Purchase and the
license agreement with Mr. Utterberg.
Supply
Agreement with Medisystems
Currently, Medisystems is our sole supplier of the completed
disposable cartridges used with our System One. We purchased
approximately $4.6 million of goods and services during
fiscal 2006. In January 2007, we entered into a seven-year
agreement with Medisystems pursuant to which Medisystems will
supply to us no less than 90% of our North American requirements
for disposable cartridges for use with the System One. Pursuant
to our policies and procedures concerning related person
transactions, which are described below, our Audit Committee
reviewed and approved the Medisystems supply agreement.
Policies
and Procedures Regarding Review, Approval and Ratification of
Related Person Transactions
Our board of directors has adopted written policies and
procedures for the review of any transaction, arrangement or
relationship in which we are a participant, the amount involved
exceeds $120,000, and one of our executive officers, directors,
director nominees or 5% stockholders (or their immediate family
members), each of whom we refer to as a related
person, has a direct or indirect material interest.
If a related person proposes to enter into such a transaction,
arrangement or relationship, which we refer to as a
related person transaction, the related person must
report the proposed related person transaction to our General
Counsel. The policy calls for the proposed related person
transaction to be reviewed and, if deemed appropriate, approved
by our Audit Committee. Any related person transactions that are
ongoing in nature will be reviewed annually.
A related person transaction reviewed under the policy will be
considered approved or ratified if it is authorized by the Audit
Committee after full disclosure of the related persons
interest in the transaction. As appropriate for the
circumstances, the Audit Committee will review and consider:
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the related persons interest in the related person
transaction;
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the approximate dollar value of the amount involved in the
related person transaction;
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the approximate dollar value of the amount of the related
persons interest in the transaction without regard to the
amount of any profit or loss;
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whether the transaction was undertaken in the ordinary course of
our business;
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whether the terms of the transaction are no less favorable to us
than terms that could have been reached with an unrelated third
party;
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the purpose of, and the potential benefits to us of, the
transaction; and
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any other information regarding the related person transaction
or the related person in the context of the proposed transaction
that would be material to investors in light of the
circumstances of the particular transaction.
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The Audit Committee may approve or ratify the transaction only
if the Audit Committee determines that, under all of the
circumstances, the transaction is in our best interests. The
Audit Committee may impose any conditions on the related person
transaction that it deems appropriate.
In addition to the transactions that are excluded by the
instructions to the SECs related person transaction
disclosure rule, our board of directors has determined that the
following transactions do not create a material direct or
indirect interest on behalf of related persons and, therefore,
are not related person transactions for purposes of this policy:
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interests arising solely from the related persons position
as an executive officer of another entity (whether or not the
person is also a director of such entity), that is a participant
in the transaction, where (a) the related person and all
other related persons own in the aggregate less than a 1% equity
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169
interest in such entity, (b) the related person and his or
her immediate family members are not involved in the negotiation
of the terms of the transaction and do not receive any special
benefits as a result of the transaction, and (c) the amount
involved in the transaction equals less than the greater of
$1,000,000 or 2% of the annual gross revenues of the company
receiving payment under the transaction; and
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a transaction that is specifically contemplated by provisions of
our charter or bylaws.
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The policy provides that transactions involving compensation of
executive officers shall be reviewed and approved by the
Compensation Committee in the manner specified in its charter.
170
NxSTAGE
PRINCIPAL STOCKHOLDERS
The following table sets forth certain information, as of
July 31, 2007, or such earlier date as indicated below,
with respect to the beneficial ownership of our common stock by:
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each person whom we know beneficially owns more than 5% of the
outstanding shares of our common stock;
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each of our directors;
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our principal executive officer, our principal financial officer
and our three other most highly compensated executive
officers; and
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all of our directors and executive officers as a group.
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The number of shares of our common stock owned by each person is
determined under the rules of the SEC and the information is not
necessarily indicative of beneficial ownership for any other
purpose. Under these rules, beneficial ownership includes any
shares as to which the individual has sole or shared voting
power or investment power and also any shares which the
individual has the right to acquire within 60 days after
July 31, 2007 through the exercise of any stock option or
other right. Unless otherwise indicated, each person has sole
investment and voting power, or shares such power with his or
her spouse, with respect to the shares set forth in the
following table. The inclusion in this table of any shares
deemed beneficially owned does not constitute an admission of
beneficial ownership of those shares.
Percentage of common stock outstanding before the Stock Purchase
is based on 29,995,126 shares of our common stock
outstanding as of July 31, 2007, and percentage of common
stock outstanding after the Stock Purchase assumes the issuance
of 6,500,000 shares to Mr. Utterberg as of
July 31, 2007. Shares of common stock subject to stock
options currently exercisable, or exercisable within
60 days, are deemed outstanding for the percentage
ownership of the person holding such stock options but are not
deemed outstanding for any other person.
Unless otherwise indicated below, the address for each person is
to the care of NxStage Medical, Inc., 439 South Union Street,
5th Floor,
Lawrence, Massachusetts 01843.
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Percentage of
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Common Stock
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Shares of
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Outstanding
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Common Stock
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Before
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After
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Beneficially
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Stock
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Stock
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Name and Address
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Owned
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Purchase
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Purchase
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5% Stockholders
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Credit Suisse (Sprout Entities)
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6,185,874
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(1)
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20.7
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%
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17.0
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%
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Eleven Madison Avenue
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New York, New York 10010
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Atlas Venture entities
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2,592,126
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(2)
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8.7
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%
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7.1
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%
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890 Winter Street, Suite 320
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Waltham, Massachusetts 02451
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Federated Investors, Inc.
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2,526,500
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(3)
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8.4
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%
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6.9
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%
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Federated Investors Tower
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1001 Liberty Avenue
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Pittsburgh, Pennsylvania 15222
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T. Rowe Price Associates,
Inc.
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2,206,403
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(4)
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7.4
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%
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6.1
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%
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100 E. Pratt Street
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Baltimore, Maryland 21202
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David S. Utterberg
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2,020,815
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(5)
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6.7
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%
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23.4
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%
|
Directors(6)
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Jeffrey H. Burbank
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825,345
|
(7)
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2.8
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%
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2.3
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%
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Philippe O. Chambon
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5,947,097
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(7)(8)
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19.8
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%
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16.3
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%
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Daniel A. Giannini
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43,232
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(7)
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*
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*
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Reid S. Perper
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1,321,819
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(7)(9)
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4.4
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%
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3.6
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%
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171
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Percentage of
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|
|
|
|
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Common Stock
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Shares of
|
|
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Outstanding
|
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|
|
Common Stock
|
|
|
Before
|
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After
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Beneficially
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Stock
|
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Stock
|
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Name and Address
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Owned
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Purchase
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Purchase
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Peter P. Phildius
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95,955
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(7)
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*
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*
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Craig W. Moore
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65,886
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(7)
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*
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*
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Other Named Executive
Officers
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Robert S. Brown
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0
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(7)
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*
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*
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Winifred L. Swan
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116,219
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(7)
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*
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*
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Philip R. Licari
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221,989
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(7)
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*
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*
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Joseph E. Turk, Jr.
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194,067
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(7)
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*
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*
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All directors and executive
officers as a group (11 persons)
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10,856,024
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(10)
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36.2
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%
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47.6
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%
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|
|
* |
|
Represents holdings of less than one percent. |
|
(1) |
|
This information is taken from a Schedule 13D/A filed on
June 22, 2006 by Credit Suisse jointly with its affiliates,
the Sprout Entities, and is as of June 9, 2006. As of
June 22, 2006, the Sprout Entities may be deemed to
beneficially own an aggregate of 6,185,874 shares of common
stock, consisting of (i) 2,359,547 shares of common
stock held directly by Sprout Capital IX, L.P.,
(ii) 2,108,034 shares of common stock held directly by
Sprout Capital VIII, L.P., (iii) 830,437 shares of
common stock held directly by Sprout Capital VII, L.P.,
(iv) 9,666 shares of common stock held directly by
Sprout CEO Fund, L.P., (v) 9,402 shares of common
stock held directly by Sprout Entrepreneurs Fund, L.P.,
(vi) 112,061 shares of common stock held directly by
Sprout IX Plan Investors, L.P., (vii) 47,203 shares of
common stock held directly by Sprout Plan Investors, L.P.,
(viii) 126,517 shares of common stock held directly by
Sprout Venture Capital, L.P., (ix) 135,480 shares of
common stock held directly by DLJ ESC II, L.P.,
(x) 174,845 shares of common stock held directly by
DLJ Capital Corporation, or DLJCC, (xi) 272,582 shares
of common stock held directly by CSFB
Fund Co-Investment
Program, L.P. and (xii) 100 shares held directly by CS
SEC USA LLC. |
|
(2) |
|
This information is taken from a Schedule 13G filed on
February 12, 2007 by Atlas Venture jointly with its
affiliates and is as of December 31, 2006. Consists of
(i) 1,502,723 shares of common stock held by Atlas
Venture Fund V, L.P., (ii) 373,324 shares of
common stock held by Atlas Venture
Fund V-A
C.V., (iii) 25,011 shares of common stock held by
Atlas Venture Entrepreneurs Fund V, L.P.,
(iv) 676,366 shares of common stock held by Atlas
Venture Fund III, L.P. and (v) 14,702 shares of
common stock held by Atlas Venture Entrepreneurs
Fund III, L.P. As general partner of certain of the
foregoing funds, and by virtue of such funds relationship
as affiliated limited partnerships, each of Atlas Venture
Associates III, L.P., or AVA III LP, and Atlas Venture
Associates V, L.P., or AVA V LP, may also be deemed to
beneficially own the foregoing shares of common stock. As the
general partner of AVA III LP and AVA V LP, respectively, Atlas
Venture Associates III, Inc., or AVA III Inc., and Atlas Venture
Associates V, Inc., or AVA V Inc., may also be deemed to
beneficially own the foregoing shares. AVA III LP, AVA V LP, AVA
III Inc. and AVA V Inc. disclaim beneficial ownership of the
shares except to the extent of their pecuniary interest therein.
In their capacities as directors of AVA III Inc. and AVA V Inc.,
each of Messrs. Axel Bichara, Jean-Francois Formela and
Christopher Spray may be deemed to beneficially own the shares.
Each of Messrs. Bichara, Formela and Spray disclaim
beneficial ownership of the shares except to the extent of his
pecuniary interest therein. |
|
(3) |
|
This information is taken from a Schedule 13G filed on
February 13, 2007 by Federated Investors, Inc. and is as of
December 31, 2006. Federated Investors, Inc. reports sole
voting power and sole dispositive power as to all
2,526,500 shares. Federated Investors, Inc. is the parent
holding company of Federated Equity Management Company and
Federated Global Investment Management Corp., each of which acts
as investment advisers to registered investment companies and
separate accounts that own shares of our common stock. Each of
these entities is a wholly-owned subsidiary of FII Holdings,
Inc., which is a wholly-owned subsidiary of Federated Investors,
Inc. The shares held by Federated Investors, Inc. are held in a
Voting Shares Irrevocable Trust, for which John F. Donahue,
Rhodora J. Donahue and J. |
172
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Christopher Donahue act as trustees. Each trustee disclaims
beneficial ownership with respect to the shares of our common
stock held by Federated Investors, Inc. |
|
(4) |
|
This information is taken from a Schedule 13G filed by T.
Rowe Price Associates, Inc. on February 14, 2007, and is as
of December 31, 2006. These securities are owned by various
individual and institutional investors for which T. Rowe Price
Associates, Inc. serves as investment advisor with power to
direct investments and/or sole power to vote the securities. For
purposes of the reporting requirements of the Exchange Act, T.
Rowe Price Associates, Inc. is deemed to be a beneficial owner
of such securities; however, T. Rowe Price Associates, Inc.
expressly disclaims that it is the beneficial owner of such
securities. Of the 2,206,403 shares of our common stock
deemed beneficially owned, T. Rowe Price Associates, Inc.
reports sole voting power as to 138,200 shares and sole
dispositive power as to 2,206,403 shares. |
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(5) |
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David Utterberg holds (a) 1,979,318 shares of our
common stock and (b) 41,497 shares of common stock
which Mr. Utterberg has the right to acquire within
60 days of July 31, 2007 upon exercise of outstanding
stock options. |
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(6) |
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David Utterberg, a 5% stockholder, is also a member of our board
of directors. |
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(7) |
|
The number of shares of our common stock that each person is
deemed to beneficially own includes the number of shares of our
common stock which such person has the right to acquire within
60 days after July 31, 2007 upon exercise of
outstanding stock options as set forth opposite his or her name: |
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Number
|
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Name
|
|
of Shares
|
|
|
Jeffrey H. Burbank
|
|
|
387,789
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|
Philippe O. Chambon
|
|
|
40,000
|
|
Daniel A. Giannini
|
|
|
43,000
|
|
Reid S. Perper
|
|
|
40,000
|
|
Peter P. Phildius
|
|
|
95,913
|
|
David S. Utterberg
|
|
|
41,497
|
|
Craig W. Moore
|
|
|
58,791
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|
Robert S. Brown
|
|
|
|
|
Winifred L. Swan
|
|
|
93,789
|
|
Philip R. Licari
|
|
|
208,962
|
|
Joseph E. Turk, Jr.
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|
|
92,772
|
|
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(8) |
|
Includes 5,900,534 shares held by various Sprout Group
entities. Dr. Chambon is a managing director of New Leaf
Venture Partners, L.L.C, or NLVP, and is a limited partner of
DLJ Associates IX, L.P., which is a general partner of Sprout
Capital IX, L.P. NLVP has entered into a sub-management
agreement with DLJCC whereby NLVP and its principals, including
Dr. Chambon, provide DLJCC with investment management
services on the investments held by various of the Sprout Group
venture capital funds including (i) 9,666 shares of
our common stock held directly by Sprout CEO Fund, L.P.,
(ii) 162,187 shares of our common stock held directly
by DLJCC, (iii) 135,480 shares of our common stock
held directly by DLJ ESC II, L.P., (iv) 830,437 shares
of our common stock held directly by Sprout Capital VII, L.P.,
(v) 2,108,034 shares of our common stock held directly
by Sprout Capital VIII, L.P., (vi) 2,359,547 shares of
our common stock held directly by Sprout Capital IX, L.P.,
(vii) 9,402 shares of our common stock held directly
by Sprout Entrepreneurs Fund, L.P.,
(viii) 112,061 shares of our common stock held
directly by Sprout IX Plan Investors, L.P.,
(ix) 126,517 shares of our common stock held directly
by Sprout Venture Capital, L.P. and (x) 47,203 shares
of our common stock held directly by Sprout Plan Investors, L.P.
Dr. Chambon expressly disclaims beneficial ownership of
these shares except to the extent of his pecuniary interest
therein. |
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(9) |
|
Includes 1,276,112 shares held by Healthcare Investment
Partners Holdings LLC, of which Mr. Perper is a Managing
Director. Mr. Perper disclaims beneficial ownership of
these shares except to the extent of his proportionate pecuniary
interest in such shares. |
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(10) |
|
Includes an aggregate of 1,102,513 shares of our common
stock which all executive officers and directors have the right
to acquire within 60 days after July 31, 2007 upon
exercise of outstanding stock options. |
173
STOCKHOLDER
PROPOSALS FOR THE 2008 ANNUAL MEETING
Proposals of stockholders intended to be presented at the 2008
Annual Meeting of Stockholders must be received by us at our
principal office in Lawrence, Massachusetts not later than
January 1, 2008 for inclusion in the proxy statement for
that meeting.
In addition, our bylaws require that we be given advance notice
of stockholder nominations for election to our board of
directors and of other matters which stockholders wish to
present for action at an annual meeting of stockholders, other
than matters included in our proxy statement in accordance with
Rule 14a-8.
The required notice must be in writing and received by our
Corporate Secretary, Winifred L. Swan, at our principal offices
not later than 90 days nor more than 120 days prior to
the first anniversary of our 2007 Annual Meeting of
Stockholders. However, if the 2008 Annual Meeting of
Stockholders is advanced by more than 20 days, or delayed
by more than 60 days, from the first anniversary of the
2007 Annual Meeting of Stockholders, notice must be received not
earlier than the 120th day prior to such annual meeting and
not later than the close of business on the later of
(1) the 90th day prior to such annual meeting and
(2) the 10th day following the date on which notice of
the date of such annual meeting was mailed or public disclosure
of the date of such annual meeting was made, whichever occurs
first. Our bylaws also specify requirements relating to the
content of the notice which stockholders must provide, including
a stockholder nomination for election to the board of directors,
to be properly presented at the 2008 Annual Meeting of
Stockholders.
DELIVERY
OF SECURITY HOLDER DOCUMENTS
Some banks, brokers and other nominee record holders may be
participating in the practice of householding proxy
statements and annual reports. This means that only one copy of
our proxy statement may have been sent to multiple stockholders
in your household. We will promptly deliver a separate copy of
either document to you if you call or write us at the following
address: 439 South Union Street, 5th Floor, Lawrence,
Massachusetts 01843, Attention: Investor Relations. If you want
to receive separate copies of the proxy statement in the future,
or if you are receiving multiple copies and would like to
receive only one copy for your household, you should contact
your bank, broker or other nominee record holder, or you may
contact us at the above address.
WHERE
YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements
and other information with the SEC. You may read and copy any
reports, proxy statements or other information filed by us at
the SECs public reference room at 100 F Street,
N.E., Room 1580, Washington, D.C. 20549. Please call
the SEC at
1-800-SEC-0330
for further information on the public reference rooms. You may
also obtain copies of these reports, proxy statements and other
documents at the SECs website, the address of which is
http://www.sec.gov.
174
INDEX
TO NxSTAGE CONSOLIDATED FINANCIAL STATEMENTS
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|
|
|
|
|
|
|
F-2
|
|
|
|
|
F-3
|
|
|
|
|
F-4
|
|
|
|
|
F-5
|
|
|
|
|
F-15
|
|
|
|
|
F-16
|
|
|
|
|
F-17
|
|
|
|
|
F-18
|
|
|
|
|
F-19
|
|
|
|
|
F-20
|
|
INDEX
TO MEDISYSTEMS GROUP COMBINED FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
F-39
|
|
|
|
|
F-40
|
|
|
|
|
F-41
|
|
|
|
|
F-42
|
|
|
|
|
F-43
|
|
|
|
|
F-44
|
|
|
|
|
F-46
|
|
F-1
NXSTAGE
MEDICAL, INC.
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
42,045,621
|
|
|
$
|
49,958,540
|
|
Short-term investments
|
|
|
10,921,716
|
|
|
|
11,843,275
|
|
Accounts receivable, net
|
|
|
6,009,991
|
|
|
|
4,301,557
|
|
Inventory
|
|
|
15,143,662
|
|
|
|
10,419,030
|
|
Prepaid expenses and other current
assets
|
|
|
479,166
|
|
|
|
1,014,688
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
74,600,156
|
|
|
|
77,537,090
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
4,018,133
|
|
|
|
3,025,560
|
|
Field equipment, net
|
|
|
23,685,353
|
|
|
|
20,615,952
|
|
Deferred cost of revenues
|
|
|
9,081,431
|
|
|
|
139,893
|
|
Other assets
|
|
|
1,784,195
|
|
|
|
406,285
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
113,169,268
|
|
|
$
|
101,724,780
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
9,565,724
|
|
|
$
|
5,918,437
|
|
Accrued expenses
|
|
|
5,371,904
|
|
|
|
4,104,058
|
|
Current portion of long-term debt
|
|
|
2,800,000
|
|
|
|
2,800,000
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
17,737,628
|
|
|
|
12,822,495
|
|
Deferred rent obligation
|
|
|
618,214
|
|
|
|
648,604
|
|
Deferred revenue
|
|
|
13,323,698
|
|
|
|
228,542
|
|
Long-term debt
|
|
|
3,216,668
|
|
|
|
4,616,667
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
34,896,208
|
|
|
|
18,316,308
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Undesignated preferred stock: par
value $0.001, 5,000,000 shares authorized; zero shares
issued and outstanding as of June 30, 2007 and
December 31, 2006
|
|
|
|
|
|
|
|
|
Common stock: par value $0.001,
100,000,000 shares authorized: 29,989,461 and
27,806,543 shares issued and outstanding as of
June 30, 2007 and December 31, 2006, respectively
|
|
|
29,990
|
|
|
|
27,807
|
|
Additional paid-in capital
|
|
|
226,544,271
|
|
|
|
206,848,097
|
|
Accumulated deficit
|
|
|
(148,515,867
|
)
|
|
|
(123,640,441
|
)
|
Accumulated other comprehensive
income
|
|
|
214,666
|
|
|
|
173,009
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
78,273,060
|
|
|
|
83,408,472
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity
|
|
$
|
113,169,268
|
|
|
$
|
101,724,780
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these condensed consolidated financial
statements.
F-2
NXSTAGE
MEDICAL, INC.
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Revenues
|
|
$
|
10,031,184
|
|
|
$
|
4,546,273
|
|
|
$
|
18,405,177
|
|
|
$
|
7,946,995
|
|
Cost of revenues
|
|
|
11,511,184
|
|
|
|
6,003,629
|
|
|
|
21,428,345
|
|
|
|
10,860,883
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (deficit)
|
|
|
(1,480,000
|
)
|
|
|
(1,457,356
|
)
|
|
|
(3,023,168
|
)
|
|
|
(2,913,888
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
5,119,820
|
|
|
|
3,758,537
|
|
|
|
9,851,400
|
|
|
|
6,951,520
|
|
Research and development
|
|
|
1,418,441
|
|
|
|
1,576,295
|
|
|
|
2,854,247
|
|
|
|
3,355,189
|
|
Distribution
|
|
|
2,997,348
|
|
|
|
1,518,685
|
|
|
|
5,341,789
|
|
|
|
2,808,284
|
|
General and administrative
|
|
|
2,525,834
|
|
|
|
2,149,016
|
|
|
|
5,192,856
|
|
|
|
4,123,745
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
12,061,443
|
|
|
|
9,002,533
|
|
|
|
23,240,292
|
|
|
|
17,238,738
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(13,541,443
|
)
|
|
|
(10,459,889
|
)
|
|
|
(26,263,460
|
)
|
|
|
(20,152,626
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
831,831
|
|
|
|
607,921
|
|
|
|
1,735,791
|
|
|
|
1,203,328
|
|
Interest expense
|
|
|
(172,689
|
)
|
|
|
(535,863
|
)
|
|
|
(347,757
|
)
|
|
|
(693,503
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
659,142
|
|
|
|
72,058
|
|
|
|
1,388,034
|
|
|
|
509,825
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(12,882,301
|
)
|
|
$
|
(10,387,831
|
)
|
|
$
|
(24,875,426
|
)
|
|
$
|
(19,642,801
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted
|
|
$
|
(0.43
|
)
|
|
$
|
(0.46
|
)
|
|
$
|
(0.84
|
)
|
|
$
|
(0.90
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding, basic and diluted
|
|
|
29,933,141
|
|
|
|
22,440,529
|
|
|
|
29,488,097
|
|
|
|
21,815,098
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these condensed consolidated financial
statements.
F-3
NXSTAGE
MEDICAL, INC.
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
Cash flows from operating
activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(24,875,426
|
)
|
|
$
|
(19,642,801
|
)
|
Adjustments to reconcile net loss
to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Loss on disposal of equipment
|
|
|
89,674
|
|
|
|
26,959
|
|
Depreciation and amortization
|
|
|
3,016,893
|
|
|
|
1,227,571
|
|
Amortization/write-off of debt
discount
|
|
|
|
|
|
|
281,666
|
|
Stock-based compensation
|
|
|
1,497,078
|
|
|
|
1,270,266
|
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(1,713,265
|
)
|
|
|
(2,053,482
|
)
|
Inventory
|
|
|
(16,690,885
|
)
|
|
|
(9,871,716
|
)
|
Prepaid expenses and other current
assets
|
|
|
537,830
|
|
|
|
31,489
|
|
Deferred cost of revenues
|
|
|
(2,704,499
|
)
|
|
|
|
|
Accounts payable
|
|
|
3,621,379
|
|
|
|
2,203,906
|
|
Accrued expenses
|
|
|
484,699
|
|
|
|
1,054,087
|
|
Deferred rent obligation
|
|
|
(30,390
|
)
|
|
|
(19,865
|
)
|
Deferred revenue
|
|
|
10,095,156
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating
activities
|
|
|
(26,671,756
|
)
|
|
|
(25,491,920
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities:
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(1,394,421
|
)
|
|
|
(802,046
|
)
|
Sales (purchases) of short-term
investments, net
|
|
|
921,559
|
|
|
|
(29,463,588
|
)
|
Increase in other assets
|
|
|
(586,967
|
)
|
|
|
(421,311
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in investing
activities
|
|
|
(1,059,829
|
)
|
|
|
(30,686,945
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities:
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of
common stock
|
|
|
19,938,683
|
|
|
|
51,380,309
|
|
Proceeds from stock option and
purchase plans
|
|
|
1,262,594
|
|
|
|
727,019
|
|
Proceeds from exercise of warrants
|
|
|
|
|
|
|
502,901
|
|
Net repayments on loans and lines
of credit
|
|
|
(1,399,999
|
)
|
|
|
(37,107
|
)
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing
activities
|
|
|
19,801,278
|
|
|
|
52,573,122
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange effect on cash
and cash equivalents
|
|
|
17,388
|
|
|
|
44,084
|
|
|
|
|
|
|
|
|
|
|
Decrease in cash and cash
equivalents
|
|
|
(7,912,919
|
)
|
|
|
(3,561,659
|
)
|
Cash and cash equivalents,
beginning of period
|
|
|
49,958,540
|
|
|
|
61,223,377
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of
period
|
|
$
|
42,045,621
|
|
|
$
|
57,661,718
|
|
|
|
|
|
|
|
|
|
|
Supplemental
Disclosure
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
342,211
|
|
|
$
|
750,840
|
|
|
|
|
|
|
|
|
|
|
Noncash Investing
Activities
|
|
|
|
|
|
|
|
|
Transfers from inventory to field
equipment
|
|
$
|
11,987,427
|
|
|
$
|
7,391,692
|
|
|
|
|
|
|
|
|
|
|
Noncash Financing
Activities
|
|
|
|
|
|
|
|
|
Deferred compensation and paid-in
capital
|
|
$
|
1,517
|
|
|
$
|
1,984
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these condensed consolidated financial
statements.
F-4
NXSTAGE
MEDICAL, INC.
(Unaudited)
|
|
1.
|
Description
of Business
|
Operations
NxStage Medical, Inc. (the Company) is a medical
device company that develops, manufactures and markets products
for the treatment of kidney failure and fluid overload. The
Companys primary product, the NxStage System One (the
System One), was designed to satisfy an unmet
clinical need for a system that can deliver the therapeutic
flexibility and clinical benefits associated with traditional
dialysis machines in a smaller, portable, easy-to-use form that
can be used by healthcare professionals and trained lay users
alike in a variety of settings, including patient homes, as well
as more traditional care settings such as hospitals and dialysis
clinics. The System One is cleared by the United States Food and
Drug Administration (the FDA) and sold commercially
in the United States for the treatment of acute and chronic
kidney failure and fluid overload. The System One consists of an
electromechanical medical device (cycler), a disposable blood
tubing set and a dialyzer (filter) pre-mounted in a disposable,
single-use cartridge, and fluids used in conjunction with
therapy.
The Company has experienced and continues to experience negative
operating margins and cash flow from operations and it expects
to continue to incur net losses in the foreseeable future. The
Company believes that it has sufficient cash and availability
under its equipment line of credit to meet its funding
requirements at least through 2007. There can be no assurance as
to the availability of additional financing or the terms upon
which additional financing may be available in the future if,
and when, it is needed. If the Company is unable to obtain
additional financing when needed, it may be required to delay,
reduce the scope of, or eliminate one or more aspects of its
business development activities, which could harm the growth of
its business. As of June 30, 2007, the Company had
approximately $53.0 million of unrestricted cash and
short-term investments.
Basis
of Presentation
The condensed consolidated financial statements reflect the
operations of the Company and its wholly-owned subsidiaries. In
the opinion of management, the interim financial statements
reflect all adjustments consisting of normal, recurring
adjustments necessary for a fair presentation of the results for
interim periods. Operating results for the three and six month
periods ended June 30, 2007 are not necessarily indicative
of results that may ultimately be achieved for the entire year
ending December 31, 2007. These condensed consolidated
financial statements should be read in conjunction with the
audited financial statements and notes included in the
Companys Annual Report on
Form 10-K
for the year ended December 31, 2006.
|
|
2.
|
Summary
of Significant Accounting Policies
|
|
|
(a)
|
Principles
of Consolidation
|
The accompanying condensed consolidated financial statements
include the accounts of the Company and its wholly-owned
subsidiaries. All material intercompany transactions and
balances have been eliminated in consolidation.
The Company recognizes revenue from product sales and services
when earned in accordance with Staff Accounting Bulletin, or
SAB, No. 104, Revenue Recognition, and Emerging
Issues Task Force, (EITF)
00-21,
Revenue Arrangements with Multiple
Deliverables(EITF 00-21).
Revenues are recognized when: (a) there is persuasive
evidence of an arrangement, (b) the product has been
shipped or services and supplies have been provided to the
customer, (c) the sales price is fixed or determinable and
(d) collection is reasonably assured.
F-5
NXSTAGE
MEDICAL, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Chronic
Care Market
Prior to 2007, the Company derived revenue in the chronic care
market from short-term rental arrangements with its customers as
its principal business model in the chronic care market. These
rental arrangements, which combine the use of the System One
with a specified number of disposable products supplied to
customers for a fixed amount per month, are recognized on a
monthly basis in accordance with agreed upon contract terms and
pursuant to a binding customer purchase order and fixed payment
terms. In the chronic care market, rental arrangements continue
to represent the majority of the arrangements the Company has
with its customers.
Beginning in 2007, the Company entered into long-term customer
contracts to sell the System One and PureFlow SL equipment along
with the right to purchase disposable products and service on a
monthly basis. Some of these agreements include other terms such
as development efforts, training, market collaborations, limited
market exclusivity and volume discounts. The equipment and
related items provided to the Companys customers in these
arrangements are considered a multiple-element sales arrangement
pursuant to
EITF 00-21.
When a sales arrangement involves multiple elements, the
deliverables included in the arrangement are evaluated to
determine whether they represent separate units of accounting.
The Company has determined that it cannot account for the sale
of equipment as a separate unit of accounting. Therefore, fees
received upon the completion of delivery of equipment are
deferred, and are recognized as revenue on a straight-line basis
over the expected term of the Companys obligation to
supply disposables and service, which is five to seven years.
The Company has deferred both the unrecognized revenue and
direct costs relating to the delivered equipment, which costs
are being amortized over the same period as the related revenue.
The Company entered into a National Service Provider Agreement
and a Stock Purchase Agreement with DaVita, Inc. on
February 7, 2007. Pursuant to
EITF 00-21,
the Company considers these agreements a single arrangement. In
connection with the Stock Purchase Agreement, DaVita purchased
2,000,000 shares of the Companys common stock for
$10.00 per share, which represented a premium of $1.50 per
share, or $3.0 million. The Company has recorded the
$3.0 million premium as deferred revenue and will recognize
this revenue ratably over seven years, consistent with its
equipment service obligation to DaVita. During the three and six
months ended June 30, 2007, the Company recognized revenue
of $107,000 and $179,000 associated with the $3.0 million
premium, respectively.
Critical
Care Market
In the critical care market, the Company structures sales as
direct product sales or as a disposables-based program in which
a customer acquires the equipment through the purchase of a
specific quantity of disposables over a specific period of time.
The Company recognizes revenue from direct product sales at the
later of the time of shipment or, if applicable, delivery in
accordance with contract terms. Under a disposables-based
program, the customer is granted the right to use the equipment
for a period of time, during which the customer commits to
purchase a minimum number of disposable cartridges or fluids at
a price that includes a premium above the otherwise average
selling price of the cartridges or fluids to recover the cost of
the equipment and provide for a profit. Upon reaching the
contractual minimum purchases, ownership of the equipment
transfers to the customer. Revenue under these arrangements is
recognized over the term of the arrangement as disposables are
delivered. During the reported periods, the majority of our
critical care revenue is derived from direct product sales.
Our contracts provide for training, technical support and
warranty services to our customers. We recognize training and
technical support revenue when the related services are
performed. In the case of extended warranties, the revenue is
recognized ratably over the warranty period.
F-6
NXSTAGE
MEDICAL, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
(c)
|
Foreign
Currency Translation and Transactions
|
Assets and liabilities of the Companys foreign operations
are translated in accordance with Statement of Financial
Accounting Standards (SFAS) No. 52,
Foreign Currency Translation. In accordance
with SFAS No. 52, assets and liabilities of the
Companys foreign operations are translated into
U.S. dollars at current exchange rates, and income and
expense items are translated at average rates of exchange
prevailing during the year. Gains and losses realized from
transactions, including intercompany balances not considered
permanent investments, denominated in foreign currencies are
included in the consolidated statements of operations and were
not material for the periods presented.
|
|
(d)
|
Cash,
Cash Equivalents and Short-Term Investments
|
The Company considers all highly-liquid investments purchased
with original maturities of 90 days or less to be cash
equivalents. Cash equivalents include amounts invested in
commercial paper and money market funds. Cash equivalents are
stated at cost plus accrued interest, which approximates market
value. Short-term investments represent commercial paper with an
original maturity date of more than 90 days, but less than
180 days. Short-term investments have been classified as
held-to-maturity and carried at amortized cost because the
Company has the intent and ability to hold the investments to
maturity.
|
|
(e)
|
Fair
Value of Financial Instruments and Concentration of Credit
Risk
|
Financial instruments consist principally of cash and cash
equivalents, accounts receivable, accounts payable and long-term
debt. The estimated fair value of these instruments approximates
their carrying value due to the short period of time to their
maturities. The fair value of the Companys debt is
estimated based on the current rates offered to the Company for
debt with the same remaining maturities. The carrying amount of
long-term debt approximates fair value.
Inventory is stated at the lower of cost or market (net
realizable value). The Company regularly reviews its inventory
quantities on hand and related cost and records a provision for
any excess or obsolete inventory based on its estimated forecast
of product demand and existing product configurations. The
Company also reviews its inventory value to determine if it
reflects lower of cost or market, with market determined based
on net realizable value. Appropriate consideration is given to
inventory items sold at negative gross margins and other factors
in evaluating net realizable value. The medical device industry
is characterized by rapid development and technological advances
that could result in obsolescence of inventory. Additionally,
the Companys estimates of future product demand may prove
to be inaccurate.
Inventories at June 30, 2007 and December 31, 2006 are
as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Purchased components
|
|
$
|
7,177,250
|
|
|
$
|
2,864,892
|
|
Finished units
|
|
|
7,966,412
|
|
|
|
7,554,138
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
15,143,662
|
|
|
$
|
10,419,030
|
|
|
|
|
|
|
|
|
|
|
Inventory is shown net of a valuation reserve of approximately
$425,000 and $492,000 at June 30, 2007 and
December 31, 2006, respectively.
F-7
NXSTAGE
MEDICAL, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
(g)
|
Property
and Equipment and Field Equipment
|
Property and equipment is carried at cost less accumulated
depreciation. A summary of the components of property and
equipment is as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Machinery, equipment and tooling
|
|
$
|
3,291,328
|
|
|
$
|
2,572,332
|
|
Leasehold improvements
|
|
|
1,112,496
|
|
|
|
987,307
|
|
Computer and office equipment
|
|
|
1,168,178
|
|
|
|
958,916
|
|
Furniture
|
|
|
493,595
|
|
|
|
408,694
|
|
Construction-in-process
|
|
|
730,928
|
|
|
|
436,902
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,796,525
|
|
|
|
5,364,151
|
|
Less accumulated depreciation and
amortization
|
|
|
(2,778,392
|
)
|
|
|
(2,338,591
|
)
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
$
|
4,018,133
|
|
|
$
|
3,025,560
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense for property and equipment was $224,000 and
$167,000 for the three months ended June 30, 2007 and 2006,
respectively, and $427,000 and $316,000 for the six months ended
June 30, 2007 and 2006, respectively.
Field equipment is carried at cost less accumulated depreciation
as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Field equipment
|
|
$
|
28,797,513
|
|
|
$
|
24,101,844
|
|
Less accumulated depreciation and
amortization
|
|
|
(5,112,160
|
)
|
|
|
(3,485,892
|
)
|
|
|
|
|
|
|
|
|
|
Field equipment, net
|
|
$
|
23,685,353
|
|
|
$
|
20,615,952
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense for field equipment was $1,352,000 and
$563,000 for the three months ended June 30, 2007 and 2006,
respectively, and $2,591,000 and $912,000 for the six months
ended June 30, 2007 and 2006, respectively.
The estimated service lives of property and equipment and field
equipment are as follows:
|
|
|
|
|
Estimated Useful Life
|
|
Leasehold improvements
|
|
Lesser of 5 years or lease
term
|
Computer and office equipment
|
|
3 years
|
Machinery, equipment and tooling
|
|
5 years
|
Furniture
|
|
7 years
|
Field equipment
|
|
5 years
|
|
|
(h)
|
Deferred
Cost of Revenues
|
Costs relating to equipment sold for which deferral of revenue
is required are capitalized and amortized ratably over the same
period in which the associated revenue is being recognized.
Deferred costs relating to equipment sold at June 30, 2007
and December 31, 2006 totaled $9.1 million and $0.1,
respectively, and are separately presented in the accompanying
condensed consolidated balance sheets. Amortization of deferred
costs charged to cost of revenue was $211,000 and $290,000 for
the three and six months ended June 30, 2007 and $12,000
and 41,000 for the three and six months ended June 30,
2006, respectively.
F-8
NXSTAGE
MEDICAL, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
For a period of one year following the delivery of products to
its critical care customers, the Company provides for product
repair or replacement if it is determined that there is a defect
in material or manufacture of the product. For sales into the
critical care market, the Company accrues estimated warranty
costs at the time of shipment based on contractual rights and
historical experience. Warranty expense is included in cost of
revenues in the consolidated statements of operations. The
Company periodically assesses the adequacy of its recorded
liability and adjusts the amount as necessary. Changes in the
Companys product warranty reserve are as follows:
|
|
|
|
|
Balance at December 31,
2006
|
|
$
|
172,244
|
|
Provision
|
|
|
194,310
|
|
Usage
|
|
|
(160,972
|
)
|
|
|
|
|
|
Balance at June 30,
2007
|
|
$
|
205,582
|
|
|
|
|
|
|
|
|
(j)
|
Distribution
Expenses
|
Distribution expenses consist of the costs incurred in shipping
products to customers and are charged to operations as incurred.
Shipping and handling costs billed to customers are included in
revenues and totaled $39,000 and $5,000 for the three months
ended June 30, 2007 and 2006, respectively, and $48,000 and
$21,000 for the six months ended June 30, 2007 and 2006,
respectively.
|
|
(k)
|
Research
and Development Costs
|
Research and development costs are charged to operations as
incurred.
The Company accounts for federal and state income taxes in
accordance with SFAS No. 109, Accounting for
Income Taxes. Under the liability method specified by
SFAS No. 109, a deferred tax asset or liability is
determined based on the difference between the financial
statement and tax basis of assets and liabilities, as measured
by the enacted tax rates. The Companys provision for
income taxes represents the amount of taxes currently payable,
if any, plus the change in the amount of net deferred tax assets
or liabilities. A valuation allowance is provided against net
deferred tax assets if recoverability is uncertain on a more
likely than not basis.
In June 2006, the Financial Accounting Standards Board
(FASB) issued FASB Interpretation (FIN)
No. 48, Accounting for Uncertainty in Income
Taxes, which clarifies the accounting for uncertainty
in income taxes recognized in an entitys financial
statements in accordance with SFAS No. 109.
FIN 48 prescribes a recognition threshold and measurement
attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a
tax return. In addition, FIN 48 provides guidance on
derecognition, classification, interest and penalties,
accounting in interim periods, disclosure and transition.
FIN 48 is effective for fiscal years beginning after
December 15, 2006. The Company adopted FIN 48 on
January 1, 2007. The adoption of FIN 48 did not have a
material impact on the Companys financial position or
results of operations. Upon adoption and as of June 30,
2007, the Company had no unrecognized tax benefits recorded.
The Company files federal, state and foreign tax returns. The
Company has accumulated significant losses since its inception
in 1998. Since the net operating losses may potentially be
utilized in future years to reduce taxable income, all of the
Companys tax years remain open to examination by the major
taxing jurisdictions to which the Company is subject.
F-9
NXSTAGE
MEDICAL, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The Company recognizes interest and penalties for uncertain tax
positions in income tax expense. Upon adoption and as of
June 30, 2007, the Company had no interest and penalty
accrual or expense.
|
|
(m)
|
Share-based
Compensation Cost
|
On January 1, 2006, the Company adopted
SFAS No. 123R, Share-Based Payment,
using a combination of the prospective and the modified
prospective transition methods. Under the prospective method,
the Company will not recognize the remaining compensation cost
for any stock option awards which had previously been valued
using the minimum value method, which was allowed until the
Companys initial filing with the SEC for the sale of
securities (i.e., stock options granted prior to July 19,
2005). Under the modified prospective method, the Company has
(a) recognized compensation expense for all share-based
payments granted after January 1, 2006 and
(b) recognized compensation expense for awards granted to
employees between July 19, 2005 and December 31, 2005
that remained unvested at December 31, 2005.
The captions in the Companys consolidated statement of
operations for the three and six months ended June 30, 2007
and 2006 include share-based compensation as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Cost of revenue
|
|
$
|
43,276
|
|
|
$
|
16,251
|
|
|
$
|
84,061
|
|
|
$
|
27,501
|
|
Selling and marketing
|
|
|
242,064
|
|
|
|
138,689
|
|
|
|
451,270
|
|
|
|
253,055
|
|
Research and development
|
|
|
41,116
|
|
|
|
28,828
|
|
|
|
82,239
|
|
|
|
56,864
|
|
General and administrative
|
|
|
410,529
|
|
|
|
591,092
|
|
|
|
880,508
|
|
|
|
932,846
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
736,985
|
|
|
$
|
774,860
|
|
|
$
|
1,497,078
|
|
|
$
|
1,270,266
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(n)
|
Recent
Accounting Pronouncements
|
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements, which addresses the
measurement of fair value where such measure is
required for recognition or disclosure purposes under GAAP.
Among other provisions, SFAS No. 157 includes
(1) a new definition of fair value, (2) a fair value
hierarchy used to classify the source of information used in
fair value measurements, (3) new disclosure requirements of
assets and liabilities measured at fair value based on their
level in the hierarchy, and (4) a modification of the
accounting presumption that the transaction price of an asset or
liability equals its initial fair value. SFAS No. 157
is effective for fiscal years beginning after November 15,
2007 (i.e., beginning in 2008 for NxStage). The Company is
currently evaluating the expected impact of
SFAS No. 157 on its consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159,
The Fair Value Option for Financial Assets and
Financial Liabilities Including an amendment of FASB
Statement No. 115, which permits entities to
choose to measure many financial instruments and certain other
items at fair value. SFAS No. 159 is effective as of
the beginning of an entitys first fiscal year that begins
after November 15, 2007. The Company is currently
evaluating if it will elect the fair value option for any of its
eligible financial instruments and other items.
Certain reclassifications were made to prior periods to conform
to current year presentation.
F-10
NXSTAGE
MEDICAL, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Common
and Preferred Stock
On February 7, 2007, the Company sold 2,000,000 shares
of its common stock to DaVita in a private placement at a price
of $10.00 per share and with aggregate net proceeds of
approximately $20.0 million. The shares sold to DaVita
represented, at the time of issuance, approximately seven
percent (7%) of the Companys issued and outstanding shares
of common stock.
On June 14, 2006, the Company completed a follow-on public
offering of 6,325,000 shares of its common stock at a price
of $8.75 per share and with aggregate net proceeds of
approximately $51.4 million. On November 1, 2005, the
Company completed its initial public offering of
6,325,000 shares of its common stock at a price of $10.00
per share and with aggregate net proceeds of approximately
$56.5 million. In connection with the initial public
offering, all shares of all series of the Companys
outstanding preferred stock were automatically converted into an
aggregate of 12,124,840 shares of common stock.
Warrants
At June 30, 2007, warrants to purchase a total of
73,460 shares of common stock were outstanding. These
warrants have a weighted average exercise price of $8.17 and
expire in December 2011. There were no grants or warrant
exercises during the six months ended June 30, 2007.
2005
Stock Purchase Plan and Employee Stock Purchase
Plan
The Company grants options and restricted stock to its employees
under the Companys 2005 Stock Incentive Plan. As of
June 30, 2007, the Company has reserved
3,153,724 shares of common stock for issuance upon exercise
of stock options, 49,478 shares for issuance under the 2005
Purchase Plan and 73,460 shares for issuance upon exercise
of warrants.
The Companys 2005 Employee Stock Purchase Plan (the
2005 Purchase Plan) originally authorized the
issuance of up to 50,000 shares of common stock to
participating employees through a series of periodic offerings.
An incremental 50,000 shares was approved by the
Companys stockholders on May 30, 2007. Each six-month
offering period begins in January or July. The first offering
under the 2005 Purchase Plan began on January 3, 2006 and
ended on June 30, 2006. An employee becomes eligible to
participate in the 2005 Purchase Plan once he or she has been
employed for at least three months and is regularly employed for
at least 20 hours per week for more than three months in a
calendar year. The price at which employees can purchase common
stock in an offering is 95 percent of the closing price of
the common stock on the NASDAQ Global Market on the day the
offering terminates, unless otherwise determined by the Board or
Compensation Committee.
The Company calculates net loss per share based on the
weighted-average number of shares of common stock outstanding,
excluding unvested shares of restricted common stock. For the
periods ended June 30 2007 and 2006; 3,227,184 and 2,769,570,
respectively, shares of common stock equivalents were not
included in the computation of net loss per share because the
effect would have been anti-dilutive.
|
|
5.
|
Comprehensive
Income (Loss)
|
SFAS No. 130, Reporting Comprehensive
Income, establishes standards for reporting
comprehensive income (loss) and its components in the body of
the financial statements. Comprehensive income (loss) consists
of net income (loss) and other comprehensive income (loss).
Other comprehensive income (loss)
F-11
NXSTAGE
MEDICAL, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
includes certain changes in equity, such as foreign currency
translation adjustments, that are excluded from results of
operations.
At June 30, 2007 and December 31, 2006, accumulated
other comprehensive income (loss) consists of foreign currency
translation adjustments.
|
|
6.
|
Financing
Arrangements
|
Debt
In December 2004, the Company entered into a debt agreement in
the principal amount of $5.0 million, which was payable
monthly over a three-year term and was secured by all the assets
of the Company. Interest accrued at a rate of 7.0% annually and
monthly principal and interest payments were made in advance. In
addition, a final interest payment of $650,000 was due at the
scheduled maturity date of December 2007, or earlier if the loan
was prepaid in advance. This additional interest payment was
accrued on a monthly basis using the interest method over the
36-month
life of the loan and was included in accrued expenses in the
accompanying condensed consolidated balance sheets. Concurrent
with entering into a new equipment line of credit in May 2006,
the Company repaid all outstanding borrowings under the
agreement in the aggregate amount of $3.4 million, which
included principal and accrued interest and the final interest
payment of $650,000. This extinguishment of debt gave rise to
the early recognition of approximately $434,000 of interest
expense for the year ended December 31, 2006.
On May 15, 2006, the Company entered into an equipment line
of credit agreement for the purpose of financing field equipment
purchases and placements. The line of credit agreement provides
for the availability of up to $20.0 million through
December 31, 2007, and borrowings bear interest at the
prime rate plus 0.5% (8.4% at June 30, 2007). Under the
line of credit agreement, $10.0 million was available
through December 31, 2006 and an additional
$10.0 million is available from January 1, 2007
through December 31, 2007. The availability of the line of
credit is subject to a number of covenants, including
maintaining certain levels of liquidity, adding specified
numbers of patients and operating within certain net loss
parameters. The Company is also required to maintain operating
and/or
investment accounts with the lender in an amount at least equal
to the outstanding debt obligation. Borrowings are secured by
all assets of the Company other than intellectual property and
are payable ratably over a three-year period from the date of
each borrowing. At June 30, 2007, the Company had
outstanding borrowings of $6.0 million and
$11.6 million of borrowing availability under the equipment
line of credit.
Annual maturities of principal under the Companys debt
obligations at June 30, 2007 are as follows:
|
|
|
|
|
2007
|
|
$
|
1,400,000
|
|
2008
|
|
|
2,800,000
|
|
2009
|
|
|
1,816,668
|
|
|
|
|
|
|
|
|
$
|
6,016,668
|
|
|
|
|
|
|
|
|
7.
|
Segment
and Enterprise Wide Disclosures
|
SFAS No. 131, Disclosures about Segments of
an Enterprise and Related Information, establishes
standards for reporting information regarding operating segments
in annual financial statements. Operating segments are
identified as components of an enterprise about which separate
discrete financial information is available for evaluation by
the chief operating decision-maker in making decisions on how to
allocate resources and assess performance. The Company views its
operations and manages its business as one operating segment.
All revenues were generated in the United States and
substantially all assets are located in the United States.
F-12
NXSTAGE
MEDICAL, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The Company sells products into two markets, critical care and
chronic care in the United States. The critical care market
consists of hospitals or facilities that treat patients that
have suddenly, and possibly temporarily, lost kidney function.
The chronic care market consists of dialysis centers and
hospitals that provide treatment options for patients that have
end-stage renal disease (ESRD). Revenues recognized
in these markets were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Critical care market
|
|
$
|
3,285,130
|
|
|
$
|
1,881,198
|
|
|
$
|
6,224,427
|
|
|
$
|
3,464,795
|
|
Chronic care market
|
|
|
6,746,054
|
|
|
|
2,665,075
|
|
|
|
12,180,750
|
|
|
|
4,482,200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
10,031,184
|
|
|
$
|
4,546,273
|
|
|
$
|
18,405,177
|
|
|
$
|
7,946,995
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three and six months ended June 30, 2007, the
Company had one customer who individually represented 30% and
27% of revenues, respectively, and 23% of accounts receivable as
of June 30, 2007. For the three and six months ended
June 30, 2006, the Company had one customer who
individually represented 18% and 16% of revenues, respectively.
One customer represented 17% of the Companys accounts
receivable as of December 31, 2006.
|
|
8.
|
Related-Party
Transactions
|
Medisystems
Corporation
Supply
Agreement
The Company purchases completed cartridges, tubing and certain
other components used in the System One disposable cartridge
from Medisystems Corporation, an entity owned by David S.
Utterberg, a 6.7% stockholder of the Company and member of the
Companys Board of Directors. The Company purchased
approximately $2.1 million and $3.8 million during the
three and six months ended June 30, 2007, and
$1.2 million and $1.9 million for the three and six
months ended June 30, 2006, respectively, of goods and
services from this related party. Amounts owed to Medisystems
Corporation totaled $665,000 and $926,000 at June 30, 2007
and December 31, 2006, respectively, and are included in
accounts payable in the accompanying condensed consolidated
balance sheets. At June 30, 2007, the Company had
commitments to purchase approximately $3.2 million of
products from Medisystems Corporation.
On January 4, 2007, the Company entered into a seven-year
Supply Agreement (the Medisystems Supply Agreement),
with Medisystems that expires on December 31, 2013. Prior
to entering into the Medisystems Supply Agreement, the Company
purchased products from Medisystems through purchase orders.
Pursuant to the terms of the Medisystems Supply Agreement, the
Company will purchase no less than ninety percent (90%) of its
North American requirements for disposal cartridges, or
Medisystems products, for use with its System One from
Medisystems. The Supply Agreement was approved by the
Companys Audit Committee and Board of Directors.
Stock
Purchase Agreement
On June 4, 2007, the Company entered into a Stock Purchase
Agreement with David S. Utterberg to purchase all of the issued
and outstanding shares of Medisystems Services Corporation, a
Nevada corporation, Medisystems Corporation, a Washington
corporation, Medisystems Europe S.p.A, a company organized under
the laws of Italy, and Medimexico s. de R.L. de C.V., a company
organized under the laws of Mexico, (referred to collectively as
the Medisystems Entities), all of which entities are
owned directly or indirectly by Mr. Utterberg, in exchange
for 6,500,000 shares of the Company (the Stock
Purchase), and a Consulting Agreement with David S.
Utterberg and DSU Medical, Inc. (DSU), a company
owned by Mr. Utterberg, to
F-13
NXSTAGE
MEDICAL, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
provide consulting, advisory and related services to the Company
for two years following the consummation of the Stock Purchase.
Under the terms of the Consulting Agreement, the Company will
pay Mr. Utterberg $200,000 annually, plus reasonable
expenses and Mr. Utterberg and DSU will agree (i) not
to compete with the Company and will not encourage or solicit
any of the Companys employees, customers or suppliers, and
(ii) will assign to the Company certain inventions and
proprietary rights received during the term of the Consulting
Agreement and will grant certain exclusive, worldwide,
perpetual, royalty-free irrevocable, sublicensable, fully paid
licenses for such inventions and proprietary rights. In the
event the Stock Purchase is consummated, Mr. Utterberg will
own approximately 23.4% of the outstanding common stock of the
Company and will continue to be a director of the Company.
The consummation of the Stock Purchase is subject to a number of
conditions, including, among other things, the termination of
applicable waiting periods under the
Hart-Scott-Rodino
Act and the approval by our stockholders of the issuance of
shares of our common stock to Mr. Utterberg in connection
with the Stock Purchase. None of these conditions has yet been
satisfied.
Consistent with the Companys Audit Committee Charter and
Related Person Transaction Policy, the Stock Purchase Agreement
and Consulting Agreement were each approved by the
Companys Audit Committee and Board of Directors.
As of June 30, 2007, the Company has capitalized
approximately $1.2 million of direct costs incurred in
conjunction with the pending Medisystems Stock Purchase. These
costs are included in other assets in the accompanying condensed
consolidated balance sheets.
|
|
9.
|
Commitments
and Contingencies
|
On March 1, 2007, the Company entered into a long-term
agreement with the Entrada Group (Entrada), to
establish manufacturing and service operations in Mexico,
initially for its cycler and PureFlow SL disposables and later
for its PureFlow SL hardware. The agreement obligates Entrada to
provide the Company with manufacturing space, support services
and a labor force through 2012. Subject to certain exceptions,
the Company is obligated for the facility fees through the term
of the agreement. The agreement may be terminated upon material
breach, generally following a
30-day cure
period.
In the second quarter of 2007, the Company started to experience
an increased incidence of reported dialysate leaks associated
with System One cartridges. The reported incidence of leaks is
higher than the Company has historically observed. In early
August 2007, the Company sent a letter to patients and customers
informing them of the increased incidence in leaks and reminding
them of existing System One labeling responsive to the risk of
leaks. The Company has characterized this notification as a
voluntary recall.
These cartridge leaks have resulted in dissatisfaction with the
System One for certain of our customers and could impair our
future growth and patient retention. The incremental leaks have
also been associated with increased cycler service costs, which
have imposed additional service pool requirements, and could
impair the Companys ability to meet future demand. If the
incidence of leaks persists or increases or if patient
satisfaction declines, the Company may incur additional costs,
however the Company deems any loss to the approximate
$2.5 million of affected inventory to be improbable at this
time, therefore no amount has been accrued to date.
Additionally, costs related to the return or replacement of
cartridges, and costs incurred to rework inventory on-hand
and/or
returned by customers, may also be incurred and could be
material to the Company. The Company has not incurred any
material costs to date in connection with this matter.
F-14
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders of NxStage Medical, Inc.
We have audited the accompanying consolidated balance sheets of
NxStage Medical, Inc. as of December 31, 2006 and 2005, and
the related consolidated statements of operations, redeemable
convertible preferred stock and stockholders equity
(deficit), and cash flows for each of the three years in the
period ended December 31, 2006. These financial statements
are the responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred
to above present fairly, in all material respects, the
consolidated financial position of NxStage Medical, Inc. at
December 31, 2006 and 2005, and the consolidated results of
its operations and its cash flows for each of the three years in
the period ended December 31, 2006, in conformity with
U.S. generally accepted accounting principles.
As discussed in Note 2 to the consolidated financial
statements, effective January 1, 2006, the Company adopted
Statement of Financial Accounting Standards No. 123R,
Share-Based Payment.
We have also audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
effectiveness of NxStage Medical, Inc.s internal control
over financial reporting as of December 31, 2006, based on
criteria established in Internal Control-Integrated
Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission and our report dated
March 14, 2007 expressed an unqualified opinion thereon.
Boston, Massachusetts
March 14, 2007
F-15
NxSTAGE
MEDICAL, INC.
CONSOLIDATED
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
49,958,540
|
|
|
$
|
61,223,377
|
|
Short-term investments
|
|
|
11,843,275
|
|
|
|
|
|
Accounts receivable, net
|
|
|
4,301,557
|
|
|
|
1,511,860
|
|
Inventory
|
|
|
10,558,923
|
|
|
|
5,956,336
|
|
Prepaid expenses and other current
assets
|
|
|
1,014,688
|
|
|
|
523,160
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
77,676,983
|
|
|
|
69,214,733
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
3,025,560
|
|
|
|
2,070,387
|
|
Field equipment, net
|
|
|
20,615,952
|
|
|
|
4,843,398
|
|
Other assets
|
|
|
406,285
|
|
|
|
446,508
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
101,724,780
|
|
|
$
|
76,575,026
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
5,918,437
|
|
|
$
|
3,027,524
|
|
Accrued expenses
|
|
|
4,104,058
|
|
|
|
2,234,621
|
|
Deferred rent obligation
|
|
|
259,036
|
|
|
|
224,694
|
|
Deferred revenue
|
|
|
228,542
|
|
|
|
114,000
|
|
Current portion of long-term debt
|
|
|
2,800,000
|
|
|
|
1,513,480
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
13,310,073
|
|
|
|
7,114,319
|
|
Deferred rent obligation
|
|
|
389,568
|
|
|
|
473,268
|
|
Long-term debt
|
|
|
4,616,667
|
|
|
|
1,633,070
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
18,316,308
|
|
|
|
9,220,657
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
(Note 8)
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Undesignated preferred stock: par
value $0.001, 5,000,000 authorized; zero shares issued and
outstanding as of December 31, 2006 and 2005
|
|
|
|
|
|
|
|
|
Common stock: par value $0.001,
100,000,000 shares authorized; 27,806,543 and
21,176,554 shares issued and outstanding as of
December 31, 2006 and 2005
|
|
|
27,807
|
|
|
|
21,177
|
|
Additional paid-in capital
|
|
|
206,848,097
|
|
|
|
151,675,548
|
|
Deferred compensation
|
|
|
|
|
|
|
(259,910
|
)
|
Accumulated deficit
|
|
|
(123,640,441
|
)
|
|
|
(84,010,669
|
)
|
Accumulated other comprehensive
income (loss)
|
|
|
173,009
|
|
|
|
(71,777
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
83,408,472
|
|
|
|
67,354,369
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity
|
|
$
|
101,724,780
|
|
|
$
|
76,575,026
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these consolidated financial
statements.
F-16
NxSTAGE
MEDICAL, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Revenues
|
|
$
|
20,812,064
|
|
|
$
|
5,993,739
|
|
|
$
|
1,884,569
|
|
Cost of revenues
|
|
|
26,121,297
|
|
|
|
9,585,286
|
|
|
|
3,438,832
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (deficit)
|
|
|
(5,309,233
|
)
|
|
|
(3,591,547
|
)
|
|
|
(1,554,263
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
14,356,062
|
|
|
|
7,549,830
|
|
|
|
3,334,028
|
|
Research and development
|
|
|
6,431,001
|
|
|
|
6,304,463
|
|
|
|
5,970,442
|
|
Distribution
|
|
|
7,092,865
|
|
|
|
2,059,279
|
|
|
|
494,786
|
|
General and administrative
|
|
|
8,703,404
|
|
|
|
4,854,471
|
|
|
|
3,603,967
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
36,583,332
|
|
|
|
20,768,043
|
|
|
|
13,403,223
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(41,892,565
|
)
|
|
|
(24,359,590
|
)
|
|
|
(14,957,486
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
3,235,672
|
|
|
|
643,417
|
|
|
|
130,347
|
|
Interest expense
|
|
|
(972,879
|
)
|
|
|
(763,437
|
)
|
|
|
(14,542
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,262,793
|
|
|
|
(120,020
|
)
|
|
|
115,805
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(39,629,772
|
)
|
|
$
|
(24,479,610
|
)
|
|
$
|
(14,841,681
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted
|
|
$
|
(1.60
|
)
|
|
$
|
(4.31
|
)
|
|
$
|
(5.81
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding, basic and diluted
|
|
|
24,817,020
|
|
|
|
5,680,566
|
|
|
|
2,555,605
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these consolidated financial
statements.
F-17
NxSTAGE
MEDICAL, INC.
CONSOLIDATED
STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS
EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
Redeemable Convertible
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
Preferred Stock
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
Receivable
|
|
|
|
|
|
Comprehensive
|
|
|
Total
|
|
|
|
|
|
|
Carrying
|
|
|
|
Common Stock
|
|
|
Paid-In
|
|
|
Deferred
|
|
|
From
|
|
|
Accumulated
|
|
|
Income
|
|
|
Comprehensive
|
|
|
|
Shares
|
|
|
Value
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Compensation
|
|
|
Stockholders
|
|
|
Deficit
|
|
|
(Loss)
|
|
|
Income (Loss)
|
|
Balance at December 31,
2003
|
|
|
10,554,162
|
|
|
$
|
55,945,612
|
|
|
|
|
2,565,226
|
|
|
$
|
2,566
|
|
|
$
|
1,518,555
|
|
|
$
|
(65,939
|
)
|
|
$
|
(289,615
|
)
|
|
$
|
(44,622,908
|
)
|
|
$
|
(21,098
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of Series F redeemable
convertible preferred stock, net of issuance costs of $31,480
|
|
|
2,747,253
|
|
|
|
20,000,002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31,480
|
)
|
|
|
|
|
|
|
|
|
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
|
1,455
|
|
|
|
1
|
|
|
|
5,264
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options issued to nonemployees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
159,124
|
|
|
|
(159,124
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
285,780
|
|
|
|
(285,780
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred
compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
90,334
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued in connection with
debt agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
422,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on marketable
securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,000
|
|
|
$
|
24,000
|
|
Forgiveness of note receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
289,615
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in cumulative translation
adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
119,909
|
|
|
|
119,909
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14,841,681
|
)
|
|
|
|
|
|
|
(14,841,681
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(14,697,772
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2004
|
|
|
13,301,415
|
|
|
$
|
75,945,614
|
|
|
|
|
2,566,681
|
|
|
$
|
2,567
|
|
|
$
|
2,391,223
|
|
|
$
|
(420,509
|
)
|
|
$
|
|
|
|
$
|
(59,496,069
|
)
|
|
$
|
122,811
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of
Series F-1
redeemable convertible preferred stock, net of issuance costs of
$34,990
|
|
|
2,197,801
|
|
|
|
15,999,993
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34,990
|
)
|
|
|
|
|
|
|
|
|
Conversion of redeemable
convertible preferred stock to common stock
|
|
|
(15,499,216
|
)
|
|
|
(91,945,607
|
)
|
|
|
|
12,124,840
|
|
|
|
12,125
|
|
|
|
91,933,482
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, net of
issuance costs
|
|
|
|
|
|
|
|
|
|
|
|
6,325,000
|
|
|
|
6,325
|
|
|
|
56,023,477
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series D warrant extension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
478,094
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
|
128,729
|
|
|
|
129
|
|
|
|
533,777
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants
|
|
|
|
|
|
|
|
|
|
|
|
31,304
|
|
|
|
31
|
|
|
|
223,029
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options issued to nonemployees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34,400
|
|
|
|
(34,400
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
58,066
|
|
|
|
(58,066
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred
compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
253,065
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Realized gain on marketable
securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(24,000
|
)
|
|
$
|
(24,000
|
)
|
Change in cumulative translation
adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(170,588
|
)
|
|
|
(170,588
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(24,479,610
|
)
|
|
|
|
|
|
|
(24,479,610
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(24,674,198
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2005
|
|
|
|
|
|
$
|
|
|
|
|
|
21,176,554
|
|
|
$
|
21,177
|
|
|
$
|
151,675,548
|
|
|
$
|
(259,910
|
)
|
|
$
|
|
|
|
$
|
(84,010,669
|
)
|
|
$
|
(71,777
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, net of
issuance costs
|
|
|
|
|
|
|
|
|
|
|
|
6,325,000
|
|
|
|
6,325
|
|
|
|
51,325,365
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
|
185,179
|
|
|
|
185
|
|
|
|
813,642
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants
|
|
|
|
|
|
|
|
|
|
|
|
78,522
|
|
|
|
79
|
|
|
|
502,822
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued under employee stock
purchase plan
|
|
|
|
|
|
|
|
|
|
|
|
28,303
|
|
|
|
28
|
|
|
|
228,848
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued to Directors in lieu
of cash
|
|
|
|
|
|
|
|
|
|
|
|
12,985
|
|
|
|
13
|
|
|
|
110,987
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,450,795
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred stock compensation
adjustment for SFAS No. 123R
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(259,910
|
)
|
|
|
259,910
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in cumulative translation
adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
244,786
|
|
|
$
|
244,786
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(39,629,772
|
)
|
|
|
|
|
|
|
(39,629,772
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(39,384,986
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2006
|
|
|
|
|
|
$
|
|
|
|
|
|
27,806,543
|
|
|
$
|
27,807
|
|
|
$
|
206,848,097
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
(123,640,441
|
)
|
|
$
|
173,009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these consolidated financial
statements.
F-18
NxSTAGE
MEDICAL, INC.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Cash flows from operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(39,629,772
|
)
|
|
$
|
(24,479,610
|
)
|
|
$
|
(14,841,681
|
)
|
Adjustments to reconcile net loss
to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Realized gain on sale of marketable
securities
|
|
|
|
|
|
|
(24,000
|
)
|
|
|
|
|
Loss on disposal of equipment
|
|
|
55,170
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
3,495,365
|
|
|
|
1,033,688
|
|
|
|
452,925
|
|
Amortization/write-off of debt
discount
|
|
|
281,666
|
|
|
|
140,833
|
|
|
|
|
|
Forgiveness of related party loans
|
|
|
|
|
|
|
|
|
|
|
289,615
|
|
Stock-based compensation
|
|
|
2,765,348
|
|
|
|
253,065
|
|
|
|
90,334
|
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(2,933,697
|
)
|
|
|
(987,595
|
)
|
|
|
(375,579
|
)
|
Inventory
|
|
|
(23,160,238
|
)
|
|
|
(5,929,697
|
)
|
|
|
(2,346,311
|
)
|
Prepaid expenses and other current
assets
|
|
|
(487,277
|
)
|
|
|
(483,598
|
)
|
|
|
11,002
|
|
Accounts payable
|
|
|
2,846,394
|
|
|
|
1,613,878
|
|
|
|
1,215,678
|
|
Accrued expenses
|
|
|
2,789,007
|
|
|
|
1,389,913
|
|
|
|
378,658
|
|
Deferred rent obligation
|
|
|
(49,358
|
)
|
|
|
36,718
|
|
|
|
(27,879
|
)
|
Deferred revenue
|
|
|
114,542
|
|
|
|
88,280
|
|
|
|
(19,179
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating
activities
|
|
|
(53,912,850
|
)
|
|
|
(27,348,125
|
)
|
|
|
(15,172,417
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(1,620,483
|
)
|
|
|
(1,198,222
|
)
|
|
|
(195,071
|
)
|
Purchases of short-term investments
|
|
|
(11,843,275
|
)
|
|
|
|
|
|
|
|
|
Sale of marketable securities
|
|
|
|
|
|
|
12,495,000
|
|
|
|
|
|
Purchase of marketable securities
|
|
|
|
|
|
|
|
|
|
|
(12,471,000
|
)
|
Increase in other assets
|
|
|
(845,479
|
)
|
|
|
(5,869
|
)
|
|
|
(135,013
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by
investing activities
|
|
|
(14,309,237
|
)
|
|
|
11,290,909
|
|
|
|
(12,801,084
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of
redeemable convertible preferred stock
|
|
|
|
|
|
|
15,965,003
|
|
|
|
19,968,522
|
|
Net proceeds from issuance of
common stock
|
|
|
51,331,690
|
|
|
|
56,507,896
|
|
|
|
|
|
Proceeds from stock option and
purchase plans
|
|
|
954,900
|
|
|
|
533,906
|
|
|
|
5,265
|
|
Proceeds from exercise of warrants
|
|
|
502,901
|
|
|
|
223,060
|
|
|
|
|
|
Proceeds from loans and lines of
credit
|
|
|
8,400,000
|
|
|
|
|
|
|
|
5,000,000
|
|
Repayment of loans and lines of
credit
|
|
|
(4,411,550
|
)
|
|
|
(1,448,164
|
)
|
|
|
(269,689
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing
activities
|
|
|
56,777,941
|
|
|
|
71,781,701
|
|
|
|
24,704,098
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange effect on cash and
cash equivalents
|
|
|
179,309
|
|
|
|
(140,607
|
)
|
|
|
28,284
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Decrease) increase in cash and
cash equivalents
|
|
|
(11,264,837
|
)
|
|
|
55,583,878
|
|
|
|
(3,241,119
|
)
|
Cash and cash equivalents,
beginning of year
|
|
|
61,223,377
|
|
|
|
5,639,499
|
|
|
|
8,880,618
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of
year
|
|
$
|
49,958,540
|
|
|
$
|
61,223,377
|
|
|
$
|
5,639,499
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
Disclosure
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
963,062
|
|
|
$
|
270,098
|
|
|
$
|
14,542
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noncash Investing
Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Transfers from inventory to field
equipment
|
|
$
|
18,598,426
|
|
|
$
|
4,366,981
|
|
|
$
|
1,091,198
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leasehold improvement allowance
|
|
$
|
|
|
|
$
|
614,798
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noncash Financing
Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued in connection with
financing activity
|
|
$
|
|
|
|
$
|
|
|
|
$
|
422,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred compensation and paid-in
capital
|
|
$
|
|
|
|
$
|
92,466
|
|
|
$
|
444,904
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of preferred stock to
common stock
|
|
$
|
|
|
|
$
|
91,945,607
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Extension of Series D warrants
|
|
$
|
|
|
|
$
|
478,094
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these consolidated financial
statements.
F-19
NxSTAGE
MEDICAL, INC.
NxStage Medical, Inc., or the Company, is a medical device
company that develops, manufactures and markets products for the
treatment of kidney failure and fluid overload. The
Companys primary product, the NxStage System One, or the
System One, was designed to satisfy an unmet clinical need for a
system that can deliver the therapeutic flexibility and clinical
benefits associated with traditional dialysis machines in a
smaller, portable,
easy-to-use
form that can be used by healthcare professionals and trained
lay users alike in a variety of settings, including patient
homes, as well as more traditional care settings such as
hospitals and dialysis clinics. The System One is cleared by the
FDA and sold commercially in the United States for the treatment
of acute and chronic kidney failure and fluid overload. The
System One consists of an electromechanical medical device
(cycler), a disposable blood tubing set and a dialyzer (filter)
pre-mounted in a disposable, single-use cartridge, and fluids
used in conjunction with therapy.
As of December 31, 2006, the Company had approximately
$61.8 million of cash, cash equivalents and short-term
investments. In February 2007, the Company received cash
proceeds of $20.0 million from the sale of 2 million
shares of its common stock to DaVita. The Company has
experienced and continues to experience negative operating
margins and cash flows from operations and it expects to
continue to incur net losses in the foreseeable future. The
Company believes that it has sufficient cash to meet its funding
requirements at least through 2007. The Company expects to be
able to extend the availability of its cash resources through
the sale rather than rental of its System One cyclers to chronic
customers in the future. There can be no assurance as to the
availability of additional financing or the terms upon which
additional financing may be available in the future if, and
when, it is needed. If the Company is unable to obtain
additional financing when needed, it may be required to delay,
reduce the scope of, or eliminate one or more aspects of its
business development activities, which could harm the growth of
its business.
|
|
2.
|
Summary
of Significant Accounting Policies
|
|
|
(a)
|
Principles
of Consolidation and Basis of Presentation
|
The accompanying consolidated financial statements include the
accounts of the Company and its
wholly-owned subsidiaries.
All material intercompany transactions and balances have been
eliminated in consolidation.
The preparation of the Companys consolidated financial
statements in conformity with GAAP requires management to make
estimates and assumptions that affect reported amounts of assets
and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting
period. Actual results could differ from those estimates.
The Company recognizes revenue from product sales and services
when earned in accordance with Staff Accounting Bulletin
(SAB) No. 104, Revenue Recognition, and
Emerging Issues Task Force (EITF)
00-21, Revenue
Arrangements with Multiple Deliverables. Revenues are
recognized when: (a) there is persuasive evidence of an
arrangement, (b) the product has been shipped or services
and supplies have been provided to the customer, (c) the
sales price is fixed or determinable and (d) collection is
reasonably assured. In the critical care market, sales are
structured as direct product sales or as a disposables-based
program in which a customer acquires the equipment through the
purchase of a specific quantity of disposables over a specific
period of time. During the reported periods, the majority of the
Companys critical care revenues were derived from direct
product sales.
F-20
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In the chronic care market, revenues are realized using
short-term rental arrangements. In the critical care market, the
Company recognizes revenue from direct product sales at the
later of the time of shipment or, if applicable, delivery in
accordance with contract terms. For the chronic care market, the
Company recognizes revenue derived from rental arrangements
ratably over the rental period. These rental arrangements
combine the use of the System One with a specified number of
disposable products supplied to customers for a fixed amount per
month. Revenue is recognized on a monthly basis in accordance
with agreed upon contract terms and pursuant to customer
purchase orders with fixed payment terms. Customer contracts in
the chronic care market are generally cancelable on
30-days
notice and there are no purchase requirements from customers
under the Companys chronic agreements.
Under a disposables-based program, the customer is granted the
right to use the equipment for a period of time, during which
the customer commits to purchase a minimum number of disposable
cartridges or fluids at a price that includes a premium above
the otherwise average selling price of the cartridges or fluids
to recover the cost of the equipment and provide for a profit.
Upon reaching the contractual minimum purchases, ownership of
the equipment transfers to the customer. Revenues under these
arrangements are recognized over the term of the arrangement as
disposables are delivered. The Company records the cost of the
equipment in inventory and amortizes the cost of the equipment
through charges to cost of revenues consistent with the
customers minimum purchase requirement.
When the Company enters into a multiple-element arrangement, it
allocates the total revenue to all elements of the arrangement
based on their respective fair values. Fair value is determined
by the price charged when each element is sold separately. The
Companys most common multiple-element arrangements are
products sold under a disposables-based program in the critical
care market as described above. The Company accounts for the
disposables-based program as a single economic transaction and
has determined that it does not have a basis to separate the
transaction into multiple elements to recognize revenue at the
time of shipment of each element. Rather, the Company recognizes
revenue related to all elements over the term of the arrangement
as the disposables are delivered.
The Companys contracts provide for training, technical
support and warranty services to its customers. The Company
recognizes training and technical support revenue when the
related services are performed. In the case of extended
warranty, the revenue is recognized ratably over the warranty
period.
|
|
(d)
|
Foreign
Currency Translation and Transactions
|
Assets and liabilities of the Companys foreign operations
are translated in accordance with Statement of Financial
Accounting Standards, or SFAS, No. 52, Foreign Currency
Translation. In accordance with SFAS No. 52,
assets and liabilities of the Companys foreign operations
are translated into U.S. dollars at current exchange rates,
and income and expense items are translated at average rates of
exchange prevailing during the year. Gains and losses realized
from transactions denominated in foreign currencies, including
intercompany balances not considered permanent investments, are
included in the consolidated statements of operations. The
Companys foreign exchange (losses)/gains totaled
($314,000), $16,000 and ($24,000) in 2006, 2005 and 2004,
respectively.
|
|
(e)
|
Cash,
Cash Equivalents and Marketable Securities
|
The Company considers all highly-liquid investments purchased
with original maturities of 90 days or less to be cash
equivalents. Cash equivalents include amounts invested in
federal agency securities, certificates of deposit, commercial
paper and money market funds. Cash equivalents are stated at
cost plus accrued interest, which approximates market value.
The Company accounts for its investments in marketable
securities in accordance with SFAS No. 115,
Accounting for Certain Investments in Debt and Equity
Securities. In accordance with SFAS No. 115, the
F-21
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Company has classified all of its short-term investments in
marketable securities as
held-to-maturity
for the year ended December 31, 2006; there were no
marketable securities at December 31, 2005.
Held-to-maturity
securities are carried at amortized cost because the Company has
the intent and ability to hold investments to maturity.
At December 31, 2006,
held-to-maturity
securities consisted of the following:
|
|
|
|
|
U.S. government securities
|
|
$
|
5,008,312
|
|
Commercial paper
|
|
|
4,896,000
|
|
Certificates of deposit
|
|
|
1,938,963
|
|
|
|
|
|
|
Total
held-to-maturity
securities
|
|
$
|
11,843,275
|
|
|
|
|
|
|
At December 31, 2006, maturities of
held-to-maturity
securities were less than one year. At December 31, 2006,
the estimated fair value of each investment approximated its
amortized cost and, therefore, there were no significant
unrecognized holding gains or losses.
|
|
(f)
|
Fair
Value of Financial Instruments and Concentration of Credit
Risk
|
Financial instruments consist principally of cash and cash
equivalents, short-term investments, accounts receivable,
accounts payable and long-term debt. The estimated fair value of
these instruments approximates their carrying value due to the
short period of time to their maturities. The fair value of the
Companys debt is estimated based on the current rates
offered to the Company for debt of the same remaining
maturities. The carrying amount of long-term debt approximates
fair value.
The Company maintains its cash in bank deposit accounts which,
at times, may exceed federally insured limits. Management
believes that the financial institutions that hold the
Companys cash are financially sound and, accordingly,
minimal credit risk exists with respect to these balances.
All of the Companys revenues are derived in the United
States from the sale of the System One and related products,
which cannot be used with any other dialysis system. If the
System One is not a successful product or is withdrawn from the
market for any reason, the Company does not have other products
in development.
The Company uses and is dependent upon four single source
suppliers of components, subassemblies and finished goods. The
Company is dependent on the ability of its suppliers to provide
products on a timely basis and on favorable pricing terms. The
loss of certain principal suppliers or a significant reduction
in product availability from principal suppliers could have a
material adverse effect on the Company. The Company believes
that its relationships with its suppliers are satisfactory.
The Company reduces gross trade accounts receivable with an
allowance for doubtful accounts. The allowance for doubtful
accounts is the Companys best estimate of the amount of
probable credit losses in the existing accounts receivable. The
Company reviews its allowance for doubtful accounts on a monthly
basis and all past due balances are reviewed individually for
collectability. Account balances are charged off against the
allowance after significant collection efforts have been made
and potential for recovery is considered remote. Provisions for
allowance for doubtful accounts are recorded in general and
administrative expenses in the accompanying consolidated
statements of operations. Activity related to allowance for
doubtful accounts consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
|
|
|
|
|
|
|
|
|
Balance at
|
|
|
|
Beginning of Year
|
|
|
Provision
|
|
|
Write-Offs
|
|
|
End of Year
|
|
|
Year ended December 31, 2006
|
|
$
|
12,266
|
|
|
$
|
50,603
|
|
|
$
|
|
|
|
$
|
62,869
|
|
Year ended December 31, 2005
|
|
$
|
21,933
|
|
|
$
|
15,750
|
|
|
$
|
(25,417
|
)
|
|
$
|
12,266
|
|
Year ended December 31, 2004
|
|
$
|
9,599
|
|
|
$
|
24,750
|
|
|
$
|
(12,416
|
)
|
|
$
|
21,933
|
|
F-22
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table summarizes the number of customers who
individually comprise greater than 10% of total revenue and
total accounts receivable:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
Accounts Receivable
|
|
|
|
|
|
|
Percent of
|
|
|
|
|
|
Percent of
|
|
|
|
Number of
|
|
|
Total
|
|
|
Number of
|
|
|
Total Accounts
|
|
Year Ended
|
|
Customers
|
|
|
Revenue
|
|
|
Customers
|
|
|
Receivable
|
|
|
December 31, 2006
|
|
|
1
|
|
|
|
19
|
%
|
|
|
1
|
|
|
|
17
|
%
|
December 31, 2005
|
|
|
3
|
|
|
|
33
|
%
|
|
|
2
|
|
|
|
25
|
%
|
December 31, 2004
|
|
|
3
|
|
|
|
37
|
%
|
|
|
3
|
|
|
|
35
|
%
|
Inventory is stated at the lower of cost (weighted-average) or
market (net realizable value). The Company regularly reviews its
inventory quantities on hand and related cost and records a
provision for any excess or obsolete inventory based on its
estimated forecast of product demand and existing product
configurations. The Company also reviews its inventory value to
determine if it reflects lower of cost or market, with market
determined based on net realizable value. Appropriate
consideration is given to inventory items sold at negative gross
margins, purchase commitments and other factors in evaluating
net realizable value.
|
|
(h)
|
Property
and Equipment and Field Equipment
|
Property and equipment and field equipment are recorded at cost.
Depreciation is provided over the estimated useful lives of the
related assets using the straight-line method for financial
statement purposes. The Company uses other depreciation methods
(generally, accelerated depreciation methods) for tax purposes
where appropriate. Amortization of leasehold improvements is
computed using the straight-line method over the shorter of the
remaining lease term or the estimated useful lives of the
improvements.
Construction in process is stated at cost, which includes the
cost of construction and other direct costs attributable to the
construction. No provision for depreciation is made on
construction in process until such time as the relevant assets
are completed and put into use. Construction in process at
December 31, 2006 represents machinery and equipment under
installation.
Repairs and maintenance are expensed as incurred. Expenditures
that increase the value or productive capacity of assets are
capitalized. When property and equipment are retired, sold, or
otherwise disposed of, the assets carrying amount and
related accumulated depreciation are removed from the accounts
and any gain or loss is included in operations.
The estimated service lives of property and equipment and field
equipment are as follows:
|
|
|
|
|
|
|
Estimated
|
|
|
|
Useful Life
|
|
|
Machinery, equipment and tooling
|
|
|
5 years
|
|
Leasehold improvements
|
|
|
Lesser of 5 years or lease term
|
|
Computer and office equipment
|
|
|
3 years
|
|
Furniture
|
|
|
7 years
|
|
Field equipment
|
|
|
5 years
|
|
|
|
(i)
|
Stock-Based
Compensation
|
Until December 31, 2005, the Company accounted for
stock-based employee compensation awards in accordance with
Accounting Principles Board, or APB, Opinion No. 25,
Accounting for Stock Issued to Employees, and
related interpretations. Accordingly, compensation expense was
recorded for stock options
F-23
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
awarded to employees and directors to the extent that the option
exercise price was less than the fair market value of the
Companys common stock on the date of grant, where the
number of shares and exercise price were fixed. The difference
between the fair value of the Companys common stock and
the exercise price of the stock option, if any, was recorded as
deferred compensation and was amortized to compensation expense
over the vesting period of the underlying stock option. All
stock-based awards to nonemployees were accounted for at their
fair value in accordance with SFAS No. 123,
Accounting for Stock-Based Compensation and
related interpretations.
On January 1, 2006, the Company adopted
SFAS No. 123R Share-Based Payment,
using a combination of the prospective and the modified
prospective transition methods. Under the prospective method,
the Company will not recognize the remaining compensation cost
for any stock option awards which had previously been valued
using the minimum value method, which was allowed until the
Companys initial filing with the Securities and Exchange
Commission, or SEC, for a public offering of securities (i.e.,
stock options granted prior to July 19, 2005). Under the
modified prospective method, the Company has (a) recognized
compensation expense for all share-based payments granted after
January 1, 2006 and (b) recognized compensation
expense for awards granted to employees between July 19,
2005 and December 31, 2005 that were unvested as of
December 31, 2005. The Company recognizes share-based
compensation expense using a straight-line method of
amortization over the vesting period.
The Company filed a registration statement on
Form S-1
for an initial public offering of its common stock on
July 19, 2005 and closed the initial public offering on
November 1, 2005. Stock options granted prior to
July 19, 2005 were valued using the minimum value method,
while stock options granted after July 19, 2005 were valued
using the Black-Scholes option-pricing model. The minimum value
method excludes the impact of stock volatility, whereas the
Black-Scholes option-pricing model includes a stock volatility
assumption in its calculation. The inclusion of a stock
volatility assumption, the principal difference between the two
methods, ordinarily yields a higher fair value.
As a result of adopting SFAS 123R on January 1, 2006,
the Companys net loss for the year ended December 31,
2006 was $2.4 million higher than if it had continued to
account for share-based compensation under APB No. 25.
Basic and diluted loss per share for the year ended
December 31, 2006 was $0.10 higher than if the Company had
continued to account for share-based compensation under APB
No. 25.
Pursuant to SFAS 123R, the Company reclassified $259,910 of
deferred compensation relating to non-qualified stock options
awarded to an executive and a consultant to additional paid-in
capital on January 1, 2006.
The Company recognized the impact of its share-based payment
plans in the consolidated statement of operations for the year
ended December 31, 2006 under SFAS 123R. The following
table presents the captions in which share-based compensation
expense is included in the Companys consolidated statement
of operations, including share-based compensation recorded in
accordance with APB No. 25:
|
|
|
|
|
|
|
Year Ended
|
|
|
|
December 31,
|
|
|
|
2006
|
|
|
Cost of revenues
|
|
$
|
64,189
|
|
Selling and marketing
|
|
|
549,972
|
|
Research and development
|
|
|
123,655
|
|
Distribution
|
|
|
7,867
|
|
General and administrative
|
|
|
2,019,665
|
|
|
|
|
|
|
Total
|
|
$
|
2,765,348
|
|
|
|
|
|
|
F-24
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The weighted-average fair value of options granted during the
year ended December 31, 2006 was $6.33. The fair value of
options at date of grant was estimated using the Black-Scholes
option-pricing model with the following assumptions:
|
|
|
|
|
Year Ended
|
|
|
December 31,
|
|
|
2006
|
|
Expected life
|
|
4.75 years(1)
|
Risk-free interest rate
|
|
4.35% - 4.88%(2)
|
Expected stock price volatility
|
|
85%(3)
|
Expected dividend yield
|
|
|
|
|
|
(1) |
|
The expected term was determined using the simplified method for
estimating expected life of plain-vanilla options. |
|
|
(2) |
|
The risk-free interest rate for each grant is equal to the
U.S. Treasury rate in effect at the time of grant for
instruments with an expected life similar to the expected option
term. |
|
|
(3) |
|
Because the Company has no options that are traded publicly and
because of its limited trading history as a public company, the
stock volatility assumption is based on an analysis of the
volatility of the common stock of comparable companies in the
medical device and technology industries. |
The Company has estimated expected forfeitures of stock options
with the adoption of SFAS 123R and records stock-based
compensation net of estimated forfeitures. In developing a
forfeiture rate estimate, the Company considered its historical
experience, its growing employee base and the limited trading
history of its common stock.
For a period of one year following the delivery of products to
its critical care customers, the Company provides for product
repair or replacement if it is determined that there is a defect
in material or manufacture of the product. For sales into the
critical care market, the Company accrues estimated warranty
costs at the time of shipment based on contractual rights and
historical experience. Warranty expense is included in cost of
revenues in the consolidated statement of operations. Following
is a rollforward of the Companys warranty accrual:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
|
|
|
|
|
|
|
|
|
Balance at
|
|
|
|
Beginning of Year
|
|
|
Provision
|
|
|
Usage
|
|
|
End of Year
|
|
|
Year ended December 31, 2006
|
|
$
|
62,071
|
|
|
$
|
308,610
|
|
|
$
|
(198,437
|
)
|
|
$
|
172,244
|
|
Year ended December 31, 2005
|
|
$
|
35,401
|
|
|
$
|
127,635
|
|
|
$
|
(100,965
|
)
|
|
$
|
62,071
|
|
Year ended December 31, 2004
|
|
$
|
9,525
|
|
|
$
|
37,941
|
|
|
$
|
(12,065
|
)
|
|
$
|
35,401
|
|
|
|
(k)
|
Distribution
Expenses
|
Distribution expenses consist of the costs incurred in shipping
products to customers and are charged to operations as incurred.
Shipping and handling costs billed to customers are included in
revenues and totaled $34,110, $42,801 and $25,754 for the years
ended December 31, 2006, 2005 and 2004, respectively.
F-25
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
(l)
|
Research
and Development Costs
|
Research and development costs are charged to operations as
incurred.
The Company accounts for federal and state income taxes in
accordance with SFAS No. 109, Accounting for
Income Taxes. Under the liability method specified by
SFAS No. 109, a deferred tax asset or liability is
determined based on the difference between the financial
statement and tax basis of assets and liabilities, as measured
by the enacted tax rates. The Companys provision for
income taxes represents the amount of taxes currently payable,
if any, plus the change in the amount of net deferred tax assets
or liabilities. A valuation allowance is provided against net
deferred tax assets if recoverability is uncertain on a more
likely than not basis.
Until the closing of the Companys initial public offering
on November 1, 2005, the Company calculated net loss per
share in accordance with SFAS No. 128,
Earnings per Share, and Emerging Issues Task
Force, or EITF,
03-6,
Participating Securities and the Two Class Method
under FASB Statement No. 128, Earnings per Share.
EITF 03-6
clarifies the use of the two-class method of
calculating earnings per share as originally prescribed in
SFAS No. 128. Effective for periods beginning after
March 31, 2004, EITF
03-6
provides guidance on how to determine whether a security should
be considered a participating security for purposes
of computing earnings per share and how earnings should be
allocated to a participating security when using the two-class
method for computing earnings per share. The Company determined
that its redeemable preferred stock represented a participating
security because it may have participated in dividends with
common stock. Therefore, the Company calculated net loss per
share consistent with the provisions of EITF
03-6 for all
periods in which its redeemable preferred stock was outstanding.
All of the Companys redeemable preferred stock converted
to common stock on November 1, 2005, the date of the
Companys initial public offering.
Accordingly, subsequent to November 1, 2005, the Company no
longer uses the two-class method and calculates net loss per
share based on the weighted average number of shares of common
stock outstanding, excluding unvested shares of restricted
common stock. The following potential common stock equivalents
were not included in the computation of diluted net loss per
share as their effect would have been anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Options to purchase common stock
|
|
|
261,635
|
|
|
|
2,683,286
|
|
|
|
1,690,561
|
|
Warrants to purchase common stock
|
|
|
|
|
|
|
169,736
|
|
|
|
203,625
|
|
Unvested shares of common stock
subject to repurchase
|
|
|
|
|
|
|
|
|
|
|
402
|
|
Redeemable convertible preferred
stock
|
|
|
|
|
|
|
10,098,497
|
|
|
|
10,165,879
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
261,635
|
|
|
|
12,951,519
|
|
|
|
12,060,467
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(o)
|
Comprehensive
Income (Loss)
|
SFAS No. 130, Reporting Comprehensive
Income, establishes standards for reporting
comprehensive income (loss) and its components in the body of
the financial statements. Comprehensive income (loss) consists
of net income (loss) and other comprehensive income (loss).
Other comprehensive income (loss) includes certain changes in
equity, such as foreign currency translation adjustments, that
are excluded from results of operations.
F-26
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
At December 31, 2006 and 2005, accumulated other
comprehensive income (loss) consists of foreign currency
translation adjustments.
|
|
(p)
|
Recent
Accounting Pronouncements
|
In June 2006, the FASB issued FIN 48, Accounting
for Uncertainty in Income Taxes, which clarifies the
accounting for uncertainty in income taxes recognized in an
entitys financial statements in accordance with
SFAS 109. FIN 48 prescribes a recognition threshold
and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected
to be taken in a tax return. In addition, FIN 48 provides
guidance on derecognition, classification, interest and
penalties, accounting in interim periods, disclosure and
transition. FIN 48 is effective for fiscal years beginning
after December 15, 2006. The Company is currently in a loss
position and does not pay income taxes; therefore the adoption
of FIN 48 is not expected to have a significant impact on
the Companys consolidated financial position or results of
operations.
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements, which addresses the
measurement of fair value where such measure is
required for recognition or disclosure purposes under GAAP.
Among other provisions, SFAS No. 157 includes
(1) a new definition of fair value, (2) a fair value
hierarchy used to classify the source of information used in
fair value measurements, (3) new disclosure requirements of
assets and liabilities measured at fair value based on their
level in the hierarchy, and (4) a modification of the
accounting presumption that the transaction price of an asset or
liability equals its initial fair value. SFAS No. 157
is effective for fiscal years beginning after November 15,
2007 (i.e., beginning in 2008 for NxStage). The Company is
currently evaluating the impact of SFAS No. 157 on its
consolidated financial statements.
Inventories at December 31, 2006 and 2005 are as follows:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Purchased components
|
|
$
|
2,864,892
|
|
|
$
|
2,026,986
|
|
Finished goods
|
|
|
7,694,031
|
|
|
|
3,929,350
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
10,558,923
|
|
|
$
|
5,956,336
|
|
|
|
|
|
|
|
|
|
|
Inventory is shown net of a valuation reserve of approximately
$492,000 and $646,000 at December 31, 2006 and 2005,
respectively.
F-27
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
4.
|
Property
and Equipment and Field Equipment
|
Property and equipment is carried at cost less accumulated
depreciation. A summary of the components of property and
equipment is as follows:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Machinery, equipment and tooling
|
|
$
|
2,572,332
|
|
|
$
|
1,613,359
|
|
Leasehold improvements
|
|
|
987,307
|
|
|
|
930,213
|
|
Computer and office equipment
|
|
|
958,916
|
|
|
|
829,298
|
|
Furniture
|
|
|
408,694
|
|
|
|
279,815
|
|
Construction-in-process
|
|
|
436,902
|
|
|
|
246,639
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,364,151
|
|
|
|
3,899,324
|
|
Less accumulated depreciation and
amortization
|
|
|
(2,338,591
|
)
|
|
|
(1,828,937
|
)
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
$
|
3,025,560
|
|
|
$
|
2,070,387
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense for property and equipment was $679,000,
$469,000 and $342,000 in 2006, 2005 and 2004, respectively.
Field equipment is carried at cost less accumulated depreciation
as follows:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Field equipment
|
|
$
|
24,101,844
|
|
|
$
|
5,521,359
|
|
Less accumulated depreciation and
amortization
|
|
|
(3,485,892
|
)
|
|
|
(677,961
|
)
|
|
|
|
|
|
|
|
|
|
Field equipment, net
|
|
$
|
20,615,952
|
|
|
$
|
4,843,398
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense for field equipment was $2.8 million,
$565,000 and $111,000 in 2006, 2005 and 2004, respectively.
Accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Payroll and related benefits
|
|
$
|
1,474,698
|
|
|
$
|
769,364
|
|
Warranty costs
|
|
|
172,244
|
|
|
|
62,071
|
|
Interest on debt
|
|
|
55,883
|
|
|
|
351,869
|
|
Audit, legal and consulting fees
|
|
|
371,647
|
|
|
|
311,700
|
|
Inventory purchases
|
|
|
707,382
|
|
|
|
|
|
Clinical trial costs
|
|
|
34,964
|
|
|
|
25,894
|
|
Costs relating to initial public
offering
|
|
|
|
|
|
|
225,434
|
|
Distribution expenses
|
|
|
946,970
|
|
|
|
144,561
|
|
Research and development expenses
|
|
|
139,569
|
|
|
|
101,828
|
|
General and administrative expenses
|
|
|
68,175
|
|
|
|
201,824
|
|
Selling and marketing expenses
|
|
|
132,526
|
|
|
|
40,076
|
|
|
|
|
|
|
|
|
|
|
Total accrued expenses
|
|
$
|
4,104,058
|
|
|
$
|
2,234,621
|
|
|
|
|
|
|
|
|
|
|
F-28
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
6.
|
Financing
Arrangements
|
Debt
In December 2004, the Company entered into a debt agreement in
the principal amount of $5.0 million, which was payable
monthly over a three-year term and was secured by all the assets
of the Company. Interest accrued at a rate of 7.0% annually and
monthly principal and interest payments were made in advance. In
addition, a final interest payment of $650,000 was due at the
scheduled maturity date of December 2007, or earlier if the loan
was prepaid in advance. This additional interest payment was
accrued on a monthly basis using the interest method over the
36-month
life of the loan and was included in accrued expenses in the
accompanying consolidated balance sheets. Concurrent with
entering into a new equipment line of credit in May 2006, the
Company repaid all outstanding borrowings in the aggregate
amount of $3.4 million, which included principal and
accrued interest and the final interest payment of $650,000.
This extinguishment of debt gave rise to the early recognition
of approximately $434,000 of interest expense for the year ended
December 31, 2006.
On May 15, 2006, the Company entered into an equipment line
of credit agreement for the purpose of financing field equipment
purchases and placements. The line of credit agreement provides
for the availability of up to $20.0 million through
December 31, 2007, and borrowings bear interest at the
prime rate plus 0.5% (8.75% as of December 31, 2006). Under
the line of credit agreement, $10.0 million was available
through December 31, 2006 and an additional
$10.0 million is available from January 1, 2007
through December 31, 2007. The availability of the line of
credit is subject to a number of covenants, including
maintaining certain levels of liquidity, adding specified
numbers of patients and operating within certain net loss
parameters. The Company is also required to maintain operating
and/or
investment accounts with the lender in an amount at least equal
to the outstanding debt obligation. Borrowings are secured by
all assets of the Company other than intellectual property and
are payable ratably over a three-year period from the date of
each borrowing. As of December 31, 2006, the Company had
outstanding borrowings of $7.4 million and
$1.6 million of borrowing availability under the equipment
line of credit.
Annual maturities of principal under the Companys debt
obligations outstanding at December 31, 2006 are as follows:
|
|
|
|
|
2007
|
|
$
|
2,800,000
|
|
2008
|
|
|
2,800,000
|
|
2009
|
|
|
1,816,667
|
|
|
|
|
|
|
|
|
$
|
7,416,667
|
|
|
|
|
|
|
|
|
7.
|
Segment
and Enterprise Wide Disclosures
|
SFAS No. 131, Disclosures about Segments of
an Enterprise and Related Information, establishes
standards for reporting information regarding operating segments
in annual financial statements. Operating segments are
identified as components of an enterprise about which separate
discrete financial information is available for evaluation by
the chief operating decision-maker in making decisions on how to
allocate resources and assess performance. The Company views its
operations and manages its business as one operating segment.
All revenues were generated in the United States and
substantially all assets are located in the United States.
The Company sells products into two markets, critical care and
chronic care. The critical care market consists of hospitals or
facilities that treat patients that have suddenly, and possibly
temporarily, lost kidney
F-29
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
function. The chronic care market consists of dialysis centers
and hospitals that provide treatment options for patients that
have end stage renal disease, or ESRD. Revenues recognized in
these markets were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Critical care market
|
|
$
|
8,079,992
|
|
|
$
|
2,829,960
|
|
|
$
|
1,332,053
|
|
Chronic care market
|
|
|
12,732,072
|
|
|
|
3,163,779
|
|
|
|
552,516
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
20,812,064
|
|
|
$
|
5,993,739
|
|
|
$
|
1,884,569
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue recognized relating to extended service
contracts in the critical care market totaled approximately
$35,000 and zero for the years ended December 31, 2006 and
2005, respectively.
|
|
8.
|
Commitments
and Contingencies
|
The Company maintains its corporate headquarters and principal
operating activities in a leased building located in Lawrence,
Massachusetts. During 2005, the Company renewed its lease
agreement through 2012. The lease agreement contains a provision
for future rent increases, requires the Company to pay executory
costs (real estate taxes, operating expenses and common
utilities) and provides for a renewal option of five years. The
total amount of rental payments due over the lease term is being
charged to rent expense on the straight-line method over the
term of the lease. Rent expense was $490,000, $461,000 and
$510,000 for the years ended December 31, 2006, 2005 and
2004, respectively. The lease agreement included a tenant
improvement allowance paid by the landlord of $614,798, which
has been recorded as both a leasehold improvement and a deferred
rent obligation.
The future minimum rental payments as of December 31, 2006
under the Companys operating leases are as follows:
|
|
|
|
|
|
|
Amount
|
|
|
2007
|
|
$
|
505,967
|
|
2008
|
|
|
531,437
|
|
2009
|
|
|
541,242
|
|
2010
|
|
|
552,005
|
|
2011
|
|
|
562,767
|
|
Thereafter
|
|
|
329,056
|
|
|
|
|
|
|
Total
|
|
$
|
3,022,474
|
|
|
|
|
|
|
The Company enters into arrangements to purchase inventory
requiring minimum purchase commitments in the ordinary course of
business.
At December 31, 2006 and 2005, deferred income tax assets
and liabilities resulted from differences in the recognition of
income and expense items for tax and financial reporting
purposes.
F-30
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Deferred tax assets (liabilities), the majority of which are
noncurrent, are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards
|
|
$
|
46,077,000
|
|
|
$
|
30,600,000
|
|
Capitalized
start-up
costs
|
|
|
|
|
|
|
457,000
|
|
Research and development credits
|
|
|
3,932,000
|
|
|
|
3,329,000
|
|
Other
|
|
|
587,000
|
|
|
|
491,000
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
50,596,000
|
|
|
|
34,877,000
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
(1,036,000
|
)
|
|
|
(141,000
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets before
valuation allowance
|
|
|
49,560,000
|
|
|
|
34,736,000
|
|
Less: Valuation allowance
|
|
|
(49,560,000
|
)
|
|
|
(34,736,000
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2006, the Company had federal and state
net operating loss carryforwards of approximately
$119.1 million and $102.9 million, respectively,
available to offset future taxable income, if any. Substantially
all net losses are in the United States. The federal net
operating loss carryforwards will expire between 2019 and 2026
if not utilized, while the state net operating loss
carryforwards will expire between 2007 and 2011 if not utilized.
The Company also had combined federal and state research and
development credit carryforwards of approximately
$3.9 million, at December 31, 2006, which begin to
expire in 2019 if not utilized. A full valuation allowance has
been recorded in the accompanying consolidated financial
statements to offset the Companys deferred tax assets
because the future realizability of such assets is uncertain.
Utilization of the net operating loss carryforwards may be
subject to an annual limitation due to the ownership percentage
change limitations provided by the Internal Revenue Code
Section 382 and similar state provisions. In the event of a
deemed change in control under Internal Revenue Code
Section 382, an annual limitation imposed on the
utilization of net operating losses may result in the expiration
of all or a portion of the net operating loss carryforwards.
The Company has $248,000 of net operating losses resulting from
excess tax deductions relating to stock-based compensation. The
Company will realize the benefit of these losses through
increases to stockholders equity in future periods when
and if the losses are utilized to reduce future tax payments.
A reconciliation of the U.S. federal statutory tax rate to
the effective tax rate is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Federal statutory rate
|
|
|
34.0
|
%
|
|
|
34.0
|
%
|
|
|
34.0
|
%
|
Research and development credits
|
|
|
1.0
|
|
|
|
1.7
|
|
|
|
2.5
|
|
Valuation allowance
|
|
|
(32.3
|
)
|
|
|
(34.8
|
)
|
|
|
(35.1
|
)
|
Other, net
|
|
|
(2.7
|
)
|
|
|
(0.9
|
)
|
|
|
(1.4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate
|
|
|
|
%
|
|
|
|
%
|
|
|
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-31
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
As of December 31, 2006, the Company has reserved
3,192,081 shares of common stock for issuance upon exercise
of stock options, 21,697 shares for issuance under the 2005
Purchase Plan and 73,460 shares for issuance upon exercise
of warrants.
Stock
Options
The Company maintains the 1999 Stock Option and Grant Plan, or
the 1999 Plan, under which 4,085,009 shares of common stock
were authorized for the granting of incentive stock options
(ISOs) and nonqualified stock options to employees,
officers, directors, advisors, and consultants of the Company.
Effective upon the closing of the Companys initial public
offering, no further grants have been or will be made under the
1999 Plan. ISOs under the 1999 Plan were granted only to
employees, while nonqualified stock options under the 1999 Plan
were granted to officers, employees, consultants and advisors of
the Company. The Companys board of directors determined
the option exercise price for incentive and nonqualified stock
options and grants, and in no event were the option exercise
prices of an incentive stock option less than 100% of the fair
market value of common stock at the time of grant, or less than
110% of the fair market value of the common stock in the event
that the employee owned 10% or more of the Companys
capital stock. All stock options issued under the 1999 Plan
expire 10 years from the date of grant and the majority of
these grants were exercisable upon the date of grant into
restricted common stock, which vests over a period of four
years. Prior to the adoption of the 1999 Plan, the Company
issued non-qualified options to purchase 55,252 shares of
common stock, of which 45,755 shares remain outstanding at
December 31, 2006.
In October 2005, the Company adopted the 2005 Plan which became
effective upon the closing of the initial public offering.
Concurrently, the Company ceased granting stock options and
other equity incentive awards under the 1999 Plan and
971,495 shares, which were then still available for grant
under the 1999 Plan, were transferred and became available for
grant under the 2005 Plan. The number of shares available for
grant under the 2005 Plan will be increased annually beginning
in 2007 by the lesser of (a) 600,000 shares, or
(b) 3% of the then outstanding shares of the Companys
common stock, or (c) a number determined by the board of
directors. Unless otherwise specified by the board of directors
or Compensation Committee, stock options issued to employees
under the 2005 Plan expire seven years from the date of grant
and generally vest over a period of four years. Stock option
grants to directors expire five years from the date of grant and
vest 100% on date of grant. At December 31, 2006, options
for the purchase of 123,651 shares of common stock are
available for future grant under the 2005 Plan. Effective
January 1, 2007, the number of shares available for grant
under the 2005 Plan was increased by 600,000 shares.
During 2006, 2005 and 2004, the Company granted a consultant
options to purchase 7,500, 5,849 and 14,624 shares of
common stock at an exercise price of $8.15 per share,
$6.84 per share and $5.47 per share, respectively. The
fair value of the 2006, 2005 and 2004 option grants was $6.35,
$5.88 and $4.69 per share, respectively, which has been
recorded as stock-based compensation and is being recognized
ratably over the awards vesting period. Further, these
stock options will be marked to market over their vesting period
based upon changes in fair value of the award. During 2005,
47,579 shares were exercised by the consultant at a
weighted average exercise price of $4.24 per share.
The fair value of options granted to consultants is estimated on
the date of grant and at each remeasurement date using the
Black-Scholes option-pricing model. The following assumptions
were used for grants made in 2006, 2005 and 2004: dividend yield
of zero percent for each year; expected volatility of 85% for
each year; risk free interest rates ranging from 4.63 to
4.68 percent; and expected life ranging from 7 to
10 years. Stock-based compensation expense related to stock
options granted to consultants was $57,409, $181,620 and $78,426
for 2006, 2005 and 2004, respectively, and is included in
general and administrative expenses in the accompanying
consolidated statements of operations.
F-32
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
With the exception of one stock option award, all stock option
awards granted to employees during 2006, 2005 and 2004 were made
at exercise prices equal to or greater than the then fair value
of the Companys common stock. The Company granted 208,962
stock options to a newly hired executive officer, or the
Executive, on October 25, 2004 with an exercise price of
$4.10 per share, which was lower than the fair value at the
date of grant of $5.47 per share. The intrinsic value of
$1.37 per option is being recognized as compensation
expense over the four-year vesting period. The Executives
stock option award was modified in March 2006 as a result of
Internal Revenue Code Section 409A. In connection with the
modification, the Executives exercise price was changed to
its fair market value on date of grant, $5.47 per share, in
exchange for $115,750 in cash paid in January 2007 and
13,027 shares of restricted stock that began vesting on
January 1, 2007. The modification resulted in additional
compensation expense of $115,750 in 2006 and will result in
stock-based compensation expense of approximately $110,000 and
$60,000 in 2007 and 2008, respectively.
During 2006, the Company entered into restricted stock
agreements with three executives pursuant to which
30,449 shares were granted with restriction periods of
three months to four years at market prices ranging from $8.92
to $13.05. The fair market value of the shares was measured on
the date of grant and is being amortized to expense over the
respective vesting periods. During the year ended
December 31, 2006, stock-based compensation relating to
these shares charged to operations was $89,482. At
December 31, 2006, the weighted-average grant date fair
value and weighted-average remaining contractual life for
outstanding shares of restricted stock was $11.40 and
4.1 years, respectively.
For stock option grants between July 1, 2004 and the
initial public offering that closed on November 1, 2005,
the Company determined the fair value of its common stock based
on a number of factors including independent valuation analyses
as well as the prices for recent issuances of preferred stock.
The Company believes that the methodologies and approaches used
were consistent with the recommendations in the Technical
Practice Aid of American Institute of Certified Public
Accountants, or AICPA, Valuation of Privately-Held-Company
Equity Securities Issued as Compensation.
A summary of the Companys stock option activity under all
plans is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
Exercise
|
|
|
|
|
|
Exercise
|
|
|
|
|
|
Exercise
|
|
Fixed Options
|
|
Shares
|
|
|
Price
|
|
|
Shares
|
|
|
Price
|
|
|
Shares
|
|
|
Price
|
|
|
Outstanding at beginning of year
|
|
|
2,683,286
|
|
|
$
|
6.22
|
|
|
|
1,690,556
|
|
|
$
|
3.97
|
|
|
|
1,290,814
|
|
|
$
|
3.63
|
|
Granted
|
|
|
754,642
|
|
|
$
|
9.25
|
|
|
|
1,217,970
|
|
|
$
|
9.02
|
|
|
|
487,879
|
|
|
$
|
4.90
|
|
Exercised
|
|
|
(177,757
|
)
|
|
$
|
4.08
|
|
|
|
(128,729
|
)
|
|
$
|
4.14
|
|
|
|
(1,455
|
)
|
|
$
|
3.62
|
|
Forfeited or expired
|
|
|
(191,741
|
)
|
|
$
|
8.96
|
|
|
|
(96,511
|
)
|
|
$
|
5.03
|
|
|
|
(86,682
|
)
|
|
$
|
4.18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at end of year
|
|
|
3,068,430
|
|
|
$
|
7.00
|
|
|
|
2,683,286
|
|
|
$
|
6.22
|
|
|
|
1,690,556
|
|
|
$
|
3.97
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at end of year
|
|
|
1,705,007
|
|
|
$
|
5.77
|
|
|
|
1,249,030
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of year
|
|
|
1,959,785
|
|
|
$
|
5.80
|
|
|
|
1,448,571
|
|
|
|
|
|
|
|
865,116
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value at December 31, 2006 was
$2.6 million for stock options outstanding,
$3.3 million for stock options vested and $3.9 million
for stock options exercisable. The intrinsic value for stock
options outstanding, vested and exercisable is calculated based
on the exercise price of the underlying awards and the market
price of the Companys common stock as of December 31,
2006, excluding
out-of-the-money
awards. The total intrinsic value of options exercised during
the year ended December 31, 2006 was $764,000. The total
fair value of shares vested during the year ended
December 31, 2006 was $4.9 million.
F-33
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table summarizes information about stock options
outstanding at December 31, 2006:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding
|
|
|
Options Exercisable
|
|
|
|
|
|
|
Weighted
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
Number
|
|
|
Remaining
|
|
|
Exercise
|
|
|
Number
|
|
|
Exercise
|
|
Range of Exercise Prices
|
|
Outstanding
|
|
|
Contractual Life
|
|
|
Price
|
|
|
Exercisable
|
|
|
Price
|
|
|
$ 0.34 to $ 0.55
|
|
|
96,551
|
|
|
|
2.3 years
|
|
|
$
|
0.36
|
|
|
|
96,551
|
|
|
$
|
0.36
|
|
$ 1.37
|
|
|
2,924
|
|
|
|
3.4 years
|
|
|
$
|
1.37
|
|
|
|
2,924
|
|
|
$
|
1.37
|
|
$ 2.74 to $ 4.10
|
|
|
817,074
|
|
|
|
5.1 years
|
|
|
$
|
3.88
|
|
|
|
817,074
|
|
|
$
|
3.88
|
|
$ 5.47 to $ 6.84
|
|
|
592,685
|
|
|
|
7.8 years
|
|
|
$
|
6.03
|
|
|
|
588,823
|
|
|
$
|
6.03
|
|
$ 7.90 to $ 9.27
|
|
|
1,163,696
|
|
|
|
7.0 years
|
|
|
$
|
8.51
|
|
|
|
237,240
|
|
|
$
|
8.54
|
|
$ 9.63 to $11.19
|
|
|
107,900
|
|
|
|
4.9 years
|
|
|
$
|
10.69
|
|
|
|
84,000
|
|
|
$
|
10.83
|
|
$12.28 to $13.65
|
|
|
287,600
|
|
|
|
5.4 years
|
|
|
$
|
12.68
|
|
|
|
133,173
|
|
|
$
|
12.59
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.34 to $13.65
|
|
|
3,068,430
|
|
|
|
6.2 years
|
|
|
$
|
7.00
|
|
|
|
1,959,785
|
|
|
$
|
5.80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes the status of the Companys
nonvested stock options:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
Grant-Date
|
|
Fixed Options
|
|
Shares
|
|
|
Fair Value
|
|
|
Nonvested at December 31, 2005
|
|
|
1,434,256
|
|
|
$
|
7.89
|
|
Granted
|
|
|
754,642
|
|
|
$
|
9.25
|
|
Vested
|
|
|
(633,734
|
)
|
|
$
|
7.76
|
|
Forfeited
|
|
|
(191,741
|
)
|
|
$
|
8.96
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2006
|
|
|
1,363,423
|
|
|
$
|
8.54
|
|
|
|
|
|
|
|
|
|
|
Certain outstanding stock option awards are subject to an early
exercise provision. Upon exercise, the award was initially
subject to a repurchase right in favor of the Company. The
repurchase right terminated upon the closing of the
Companys initial public offering.
As of December 31, 2006, approximately $4.2 million of
unrecognized stock compensation cost related to nonvested awards
(net of estimated forfeitures) is expected to be recognized over
a weighted-average period of 3.5 years.
Employee
Stock Purchase Plan
The Companys 2005 Employee Stock Purchase Plan, or the
2005 Purchase Plan, authorizes the issuance of up to
50,000 shares of common stock to participating employees
through a series of periodic offerings. Each six-month offering
period begins in January or July. An employee becomes eligible
to participate in the 2005 Purchase Plan once he or she has been
employed for at least three months and is regularly employed for
at least 20 hours per week for more than three months in a
calendar year. The price at which employees can purchase common
stock in an offering is 95 percent of the closing price of
the Companys common stock on the NASDAQ Global Market on
the day the offering terminates, unless otherwise determined by
the board of directors or Compensation Committee.
F-34
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The weighted-average fair value of stock purchase rights granted
as part of the Companys 2005 Purchase Plan during the year
ended December 31, 2006 was $2.30 per share. The fair
value of the employees stock purchase rights was estimated
using the Black-Scholes option-pricing model with the following
assumptions:
|
|
|
|
|
Year Ended
|
|
|
December 31,
|
|
|
2006
|
|
Expected life
|
|
6 months
|
Risk-free interest rate
|
|
4.42% - 5.11%
|
Expected stock price volatility
|
|
50.9% - 67.0%
|
Expected dividend yield
|
|
|
On June 30, 2006, the Companys first offering under
the 2005 Purchase Plan closed, resulting in the purchase of
10,748 shares of common stock on behalf of employee
participants. On December 29, 2006, the Companys
second offering under the 2005 Purchase Plan closed, resulting
in the purchase of 17,555 shares of common stock on behalf
of employee participants. As of December 31, 2006, the
maximum number of shares available for future issuance under the
2005 Purchase Plan is 21,697.
The Company recognized share-based compensation expense of
$57,000 for the year ended December 31, 2006 relating to
the 2005 Purchase Plan.
|
|
11.
|
Employee
Benefit Plan
|
The Company has a 401(k) retirement plan (the 401(k) Plan) for
the benefit of eligible employees, as defined. Each participant
may elect to contribute up to 25% of his or her compensation to
the 401(k) Plan each year, subject to certain IRS limitations.
The Company contributes 100% of the first 3% of the
employees contribution and 50% of the next 2% of the
employees contribution. The Company contributed $563,000,
$363,000 and $214,000 to the 401(k) Plan in 2006, 2005 and 2004,
respectively.
Common
and Preferred Stock
On June 14, 2006, the Company completed a follow-on public
offering of 6,325,000 shares of its common stock at a
price of $8.75 per share and with aggregate net proceeds of
approximately $51.3 million. On November 1, 2005,
the Company completed its initial public offering of
6,325,000 shares of its common stock at a price of
$10.00 per share and with aggregate net proceeds of
approximately $56.5 million. In connection with the initial
public offering, all shares of all series of the Companys
outstanding preferred stock were automatically converted into an
aggregate of 12,124,840 shares of common stock.
On September 15, 2005, the board of directors declared a
one-for-1.3676
reverse stock split of the outstanding shares of common stock.
All references in the consolidated financial statements to the
number of shares outstanding, per share amounts and stock option
data of the Companys common stock have been retroactively
adjusted to reflect the effect of the reverse stock split for
all periods presented.
On July 8, 2005, the Company amended its certificate of
incorporation, as amended to (a) increase the number of
authorized shares of preferred stock to 15,759,660 shares
and (b) designate 2,197,801 shares of
Series F-1
Preferred Stock. On September 19, 2005, the Company further
amended its certificate of incorporation, as amended to
authorize 30,000,000 shares of common stock. On
October 14, 2005, the Company authorized
5,000,000 shares of undesignated preferred stock. In
connection with its initial public offering, the Company further
amended and restated its certificate of incorporation to
authorize 100,000,000 shares of common stock, par value
$0.001 per share.
F-35
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Prior to the initial public offering, the Company had authorized
several series of preferred stock, $0.001 par value, of
which 1,875,000 shares were designated as Series B,
1,155,169 shares were designated as Series C,
5,011,173 shares were designated as Series D,
2,690,846 shares were designated as Series E,
2,829,671 shares were designated as Series F and
2,197,801 shares were designated as
Series F-1.
During 1999, the Company sold 1,875,000 shares of
Series B Preferred Stock at $2.67 per share, resulting
in net proceeds of $4,968,250. Upon the closing of the
Series B Preferred Stock financing, all shares of the
Companys Series A Preferred Stock converted into an
equal number of shares of the Companys common stock. On
January 22, 2000, the Company sold 1,151,632 shares of
Series C Preferred Stock at $5.21 per share, resulting
in net proceeds of $5,957,891. On May 21, 2001, the Company
sold 4,857,622 shares of Series D Preferred Stock at
$5.97 per share, resulting in net proceeds of $24,218,379.
On April 15, 2003, the Company sold 2,669,908 shares
of Series E Preferred Stock at $5.97 per share, resulting
in net proceeds of $15,892,537. On August 18, 2004, the
Company sold 2,747,253 shares of Series F Preferred
Stock at $7.28 per share, resulting in net proceeds of
$19,968,522. On July 8, 2005 and July 15, 2005, the
Company sold an aggregate of 2,197,801 shares of
Series F-1
Preferred Stock at $7.28 per share, resulting in net
proceeds of approximately $15,965,003.
Warrants
At December 31, 2006, warrants to purchase a total of
73,460 shares of common stock were outstanding. These
warrants have a weighted average exercise price of
$8.17 per share and expire in December 2011. During the
year ended December 31, 2006, certain warrant holders
exercised warrants to purchase 78,522 shares of the
Companys common stock for aggregate proceeds of
approximately $503,000. During the year ended December 31,
2005, certain warrant holders exercised warrants to purchase
31,304 shares of the Companys common stock for
aggregate proceeds of approximately $223,000.
Four of the Companys significant shareholders invested in
the Companys initial public offering. Three of these
shareholders held warrants to purchase Series D Preferred
Stock, which were due to expire on November 22, 2005,
during the six month
lock-up
period required by the underwriting agreement entered into in
connection with the initial public offering. In November 2005,
the Company offered to extend the exercise period of the
warrants held by these three investors through May 31,
2006. Two of these investors with warrants for a total of
80,968 shares accepted the Companys offer to extend
the exercise period. The extension of the warrants had no net
effect on the financial position or results of operations of the
Company. The fair value on date of modification was calculated
at $478,094 and has been accounted for within the additional
paid-in capital account, as both an increase to the cost of the
initial public offering, offset by a corresponding credit to
reflect the value of the warrant extension.
Notes Receivable
from Stockholders
During 1999 and 2000, the Company entered into note agreements
with four officers of the Company totaling $289,615. These full
recourse notes were issued in connection with the exercise of
stock options by the officers and accrued interest at a range of
5.2% to 5.5%. The notes contained a 25% recourse provision and
were secured by 476,776 shares of the Companys common
stock held by the officers upon exercise of the stock options.
In 2004, these notes were cancelled by the Company and the
amount of the notes was charged to compensation expense.
|
|
13.
|
Related-Party
Transactions
|
The Company purchases completed cartridges, tubing and certain
other components used in the System One disposable cartridge
from Medisystems Corporation, an entity owned by a stockholder
of the Company and member of the Companys board of
directors. The Company purchased approximately
$4.1 million, $896,000 and $232,000 during 2006, 2005 and
2004, respectively, of goods and services from this related
F-36
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
party. Amounts owed to Medisystems Corporation totaled $926,000
and $81,000 at December 31, 2006 and 2005, respectively,
and are included in accounts payable in the accompanying
consolidated balance sheets.
On January 4, 2007, the Company entered into a seven-year
Supply Agreement, or the Supply Agreement with Medisystems that
expires on December 31, 2013. Prior to this Supply
Agreement, the Company purchased products from Medisystems
through purchase orders. Pursuant to the terms of the Supply
Agreement, the Company will purchase no less than ninety percent
(90%) of its North American requirements, or Requirements, for
disposable cartridges, or the Products, for use with its System
One from Medisystems.
On January 5, 2007, the Company entered into a long-term
supply agreement with Membrana GmbH pursuant to which Membrana
has agreed to supply, on an exclusive basis, capillary membranes
for use in the filters used with the System One for ten years.
In exchange for Membranas agreement to pricing reductions
based on volumes ordered, the Company has agreed to purchase a
base amount of membranes per year. The agreement may be
terminated upon a material breach, generally following a sixty
day cure period.
On February 7, 2007, the Company entered into a National
Service Provider Agreement, or the Agreement, with DaVita Inc.,
or DaVita, its largest customer. Pursuant to the terms of the
Agreement, the Company granted DaVita certain market rights for
the System One and related supplies for home hemodialysis
therapy. DaVita is granted exclusive rights in a small
percentage of geographies, which geographies collectively
represent less than ten percent (10%) of the U.S. ESRD
patient population, and limited exclusivity in the majority of
all other U.S. geographies, subject to DaVitas
meeting certain requirements, including patient volume
commitments and new patient training rates. Under the agreement,
the Company can continue to sell to other clinics in the
majority of geographies. If certain minimum patient numbers or
training rates are not achieved, DaVita can lose all or part of
its preferred geographic rights. The Agreement limits, but does
not prohibit, the sale by the Company of the System One for
chronic patient home hemodialysis therapy to any provider that
is under common control or management of a parent entity that
collectively provides dialysis services to more than 25% of
U.S. chronic dialysis patients and that also supplies
dialysis products.
The Agreement has an initial term of three years, terminating on
December 31, 2009, and DaVita has the option of renewing
the Agreement for four additional periods of six months if
DaVita meets certain patient volume targets.
Under the Agreement, DaVita committed to purchase all of its
existing System One equipment currently being rented from the
Company (for a purchase price of approximately
$5.0 million) and to buy a significant percentage of its
future System One equipment needs. DaVita is granted most
favored nations pricing for the products purchased under the
Agreement provided that DaVita achieves certain requirements,
including certain patient volume targets. Further, the Agreement
contemplates certain collaborations between the parties,
including efforts dedicated towards advancing market awareness
of the Companys therapies and home and more frequent
hemodialysis.
Either party may terminate the Agreement if the other party
becomes the subject of bankruptcy or similar proceedings or
loses its eligibility to bill for services under the Medicare or
Medicaid programs.
In connection with the Agreement, the Company issued and sold to
DaVita 2,000,000 shares (the Shares) of its
common stock, $0.001 par value per share, at a purchase
price of $10.00 per share, for an aggregate purchase price
of $20.0 million pursuant to the terms of the Stock
Purchase Agreement dated as of February 7, 2007 by and
between the Company and DaVita (the Stock Purchase
Agreement). The Shares represent approximately seven
percent (7%) of the Companys issued and outstanding shares
of common stock.
F-37
NxSTAGE
MEDICAL, INC.
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In connection with the issuance of the Shares, the Company and
DaVita entered into a Registration Rights Agreement. Pursuant to
the Registration Rights Agreement, the Company agreed to file a
registration statement on
Form S-3
with respect to the resale by DaVita of the Shares, and for the
registration statement to be declared effective by the SEC. In
addition, the Company shall use commercially reasonable efforts
to keep the Registration Statement continuously effective until
the date which is the earliest of (i) two years after the
Registration Statement is declared effective by the SEC,
(ii) such time as all the securities covered by the
Registration Statement have been publicly sold or
(iii) such time as all securities may be sold pursuant to
Rule 144(k) without volume restrictions. If the Company is
unable to meet the above registration requirements, the Company
must (a) transfer cash consideration to DaVita equal to one
percent (1.0%) of the aggregate purchase price paid for the
Shares (i.e., $200,000) and (b) make a monthly pro rata
cash payment equal to 1.0% of the aggregate purchase price until
cured. The Registration Rights Agreement provides for no
limitation to the maximum potential consideration that may be
paid by the Company. The Company believes the likelihood is
remote that it will owe an obligation resulting from the
Registration Rights Agreement.
|
|
15.
|
Quarterly
Financial Data (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2006
|
|
|
|
March 31,
|
|
|
June 30,
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2006
|
|
|
2006
|
|
|
2006
|
|
|
Revenues
|
|
$
|
3,400,722
|
|
|
$
|
4,546,273
|
|
|
$
|
5,511,774
|
|
|
$
|
7,353,295
|
|
Gross profit (deficit)
|
|
|
(1,456,532
|
)
|
|
|
(1,457,356
|
)
|
|
|
(1,108,494
|
)
|
|
|
(1,286,851
|
)
|
Net loss
|
|
|
(9,254,970
|
)
|
|
|
(10,387,831
|
)
|
|
|
(9,575,636
|
)
|
|
|
(10,411,335
|
)
|
Net loss per common share, basic
and diluted
|
|
$
|
(0.44
|
)
|
|
$
|
(0.46
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.37
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2005
|
|
|
|
March 31,
|
|
|
June 30,
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2005
|
|
|
2005
|
|
|
2005
|
|
|
Revenues
|
|
$
|
1,033,792
|
|
|
$
|
1,403,383
|
|
|
$
|
1,496,785
|
|
|
$
|
2,059,779
|
|
Gross profit (deficit)
|
|
|
(748,373
|
)
|
|
|
(657,996
|
)
|
|
|
(774,079
|
)
|
|
|
(1,411,099
|
)
|
Net loss
|
|
|
(4,909,131
|
)
|
|
|
(5,606,652
|
)
|
|
|
(6,589,913
|
)
|
|
|
(7,373,914
|
)
|
Net loss per common share, basic
and diluted
|
|
$
|
(1.91
|
)
|
|
$
|
(2.18
|
)
|
|
$
|
(2.57
|
)
|
|
$
|
(0.49
|
)
|
F-38
Report
of Independent Certified Public Accountants
Medisystems Corporation
Seattle, Washington
We have audited the combined balance sheets of Medisystems Group
Companies (the Group) as of December 31, 2006,
and 2005 and the related combined statements of income,
comprehensive income (loss) and retained earnings (deficit) and
of cash flows for each of the three years in the period ended
December 31, 2006. These financial statements are the
responsibility of the Groups management. Our
responsibility is to express an opinion on these financial
statements based on our audits. We did not audit the financial
statements of Medisystems Europe S.p.A., or Medimexico, S. de
R.L. de C.V., both members of the combined Group, which
statements reflect total assets of 13 and 18 percent of the
combined Group as of December 31, 2006, and 2005,
respectively. Those statements were audited by other auditors,
whose reports thereon have been furnished to us, and our
opinion, insofar as it relates to the amounts included for the
Group, is based solely on the reports of the other auditors.
We conducted our audits in accordance with auditing standards
generally accepted in the United States of America as
established by the American Institute of Certified Public
Accountants. Those standards require that we plan and perform
the audit to obtain reasonable assurance about whether the
financial statements are free of material misstatement. An audit
includes consideration of internal control over financial
reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of
expressing an opinion on the effectiveness of the Companys
internal control over financial reporting. Accordingly we
express no such opinion. An audit also includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles
used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We
believe that our audits and the reports of other auditors
provide a reasonable basis for our opinion.
In our opinion, based on our audits and the reports of the other
auditors, the combined financial statements referred to above
present fairly, in all material respects, the combined financial
position of the Medisystems Group Companies as of
December 31, 2006 and 2005 and the combined results of its
operations and its cash flows for each of the three years in the
period ended December 31, 2006 in conformity with
accounting principles generally accepted in the United States of
America.
Seattle, Washington
July 13, 2007
F-39
Independent
Auditors Report
To the
Director of
Medisystems Europe S.p.A.
We have audited the balance sheets of Medisystems Europe S.p.A.
(the Company) as of December 31, 2006, and
2005, and the related statements of operations,
stockholders equity, and cash flows for the each of the
three years in the period ended December 31, 2006 (all
expressed in euros and not presented separately herein). These
financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with auditing standards
generally accepted in the United States of America. Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes consideration
of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion
on the effectiveness of the Companys internal control over
financial reporting. Accordingly, we express no such opinion. An
audit also includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial
statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our opinion, such financial statements present fairly, in all
material respects, the financial position of the Company as of
December 31, 2006 and 2005, and the results of its
operations and its cash flows for the each of the three years in
the period ended December 31, 2006 in conformity with
accounting principles generally accepted in the United States of
America.
As indicated in Note 1 to the financial statements (not
presented separately herein), substantially all of the
Companys products are sold to Medisystems Corporation, a
US Corporation and shareholder of the Company.
DELOITTE & TOUCHE S.p.A.
Mauro Di Bartolomeo
Partner
Bologna, Italy
July 11, 2007
F-40
Independent
Auditors Report
To the Board
of Directors and owners
Medimexico, S. de R.L. de C.V.
Tijuana, Baja California, México
We have audited the balance sheets of Medimexico, S. de R.L. de
C.V. (a 99.73% owned subsidiary of Medisystems Corporation), as
of December 31, 2006 and 2005, and the related statement of
operations, changes in ownership equity, and cash flows for each
of the three years in the period ended December 31, 2006,
not included separately herein. These financial
statements are the responsibility of the Companys
management. Our responsibility is to express an opinion on these
financial statements based on our audits.
We conducted our audits in accordance with auditing standards
generally accepted in United States of America. Those standards
require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of
material misstatements and are prepared in accordance with the
accounting principles generally accepted in the United States of
America. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as
well as evaluating the overall financial statements
presentation. We believe that our audit provides a reasonable
basis for our opinion.
In our opinion, for the purposes of inclusion in the
consolidated financial statements of the Parent Company, the
financial statements referred to above, present fairly, in all
material respects, the financial position of Medimexico, S. de
R.L. de C.V., as of December 31, 2006 and 2005, and the result
of its operations, the changes in its ownership equity and its
cash flows for each of the three years in the period ended
December 31, 2006 in conformity with accounting principles
generally accepted in the United States of America.
As discussed in note 1 to the financial statements, the company
operates under Mexican Maquiladora program, thereby providing
labor services for the manufacturing of disposable medical
devices solely for the Parent Company. The company recognizes
its results of operations on the cost agreement, celebrated with
the parent company. Therefore, the accompanying financial
statements may not necessarily be indicative of the conditions
that would have prevailed or the results of operations or cash
flows that the company would have had if it were not dependent
upon such an affiliation.
Kim Quezada y Asociados, S.C.
C.P.C. Carlos Alejandro Kim Sánchez
Partner
March 31, 2007.
F-41
MEDISYSTEMS
GROUP
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
ASSETS
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
941
|
|
|
$
|
1,622
|
|
|
$
|
2,501
|
|
Accounts receivable:
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade, net of allowance for
doubtful accounts of $50,000 for June 30, 2007 and
December 31, 2006 and 2005
|
|
|
4,837
|
|
|
|
4,649
|
|
|
|
1,400
|
|
Other
|
|
|
1,138
|
|
|
|
7,014
|
|
|
|
1,033
|
|
Inventories
|
|
|
8,668
|
|
|
|
7,854
|
|
|
|
7,662
|
|
Other current assets
|
|
|
525
|
|
|
|
268
|
|
|
|
335
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
16,109
|
|
|
|
21,407
|
|
|
|
12,931
|
|
PROPERTY, EQUIPMENT, AND LEASEHOLD
IMPROVEMENTS Net
|
|
|
3,726
|
|
|
|
3,450
|
|
|
|
2,573
|
|
OTHER ASSETS
|
|
|
138
|
|
|
|
143
|
|
|
|
184
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
|
|
$
|
19,973
|
|
|
$
|
25,000
|
|
|
$
|
15,688
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY (DEFICIT)
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
9,240
|
|
|
$
|
8,678
|
|
|
$
|
7,464
|
|
Accrued royalties
|
|
|
4,494
|
|
|
|
11,170
|
|
|
|
8,750
|
|
Due to affiliates
|
|
|
45
|
|
|
|
121
|
|
|
|
|
|
Accrued expenses
|
|
|
2,467
|
|
|
|
2,974
|
|
|
|
3,357
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
16,246
|
|
|
|
22,943
|
|
|
|
19,571
|
|
NONCURRENT LIABILITIES
|
|
|
773
|
|
|
|
785
|
|
|
|
725
|
|
COMMITMENTS (See Notes)
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS EQUITY
(DEFICIT):
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital stock
|
|
|
443
|
|
|
|
448
|
|
|
|
325
|
|
Retained earnings (deficit)
|
|
|
2,543
|
|
|
|
866
|
|
|
|
(4,825
|
)
|
Accumulated other comprehensive
loss
|
|
|
(32
|
)
|
|
|
(42
|
)
|
|
|
(108
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
(deficit)
|
|
|
2,954
|
|
|
|
1,272
|
|
|
|
(4,608
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
|
|
$
|
19,973
|
|
|
$
|
25,000
|
|
|
$
|
15,688
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these combined financial statements.
F-42
MEDISYSTEMS
GROUP
COMBINED STATEMENTS OF INCOME, COMPREHENSIVE INCOME (LOSS),
AND
RETAINED EARNINGS (DEFICIT)
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended
|
|
|
For The Year Ended
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
NET SALES
|
|
$
|
32,028
|
|
|
$
|
30,565
|
|
|
$
|
62,577
|
|
|
$
|
57,904
|
|
|
$
|
62,848
|
|
COST OF GOODS SOLD
|
|
|
23,275
|
|
|
|
23,119
|
|
|
|
47,782
|
|
|
|
44,227
|
|
|
|
46,653
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT
|
|
|
8,753
|
|
|
|
7,446
|
|
|
|
14,795
|
|
|
|
13,677
|
|
|
|
16,195
|
|
OPERATING EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing
|
|
|
922
|
|
|
|
1,278
|
|
|
|
2,280
|
|
|
|
2,175
|
|
|
|
1,916
|
|
Research and development
|
|
|
877
|
|
|
|
1,103
|
|
|
|
2,317
|
|
|
|
2,186
|
|
|
|
1,638
|
|
Distribution
|
|
|
491
|
|
|
|
684
|
|
|
|
1,238
|
|
|
|
1,187
|
|
|
|
1,172
|
|
General and administrative
|
|
|
1,779
|
|
|
|
1,867
|
|
|
|
4,382
|
|
|
|
4,540
|
|
|
|
7,719
|
|
Royalty to affiliate
|
|
|
2,661
|
|
|
|
2,175
|
|
|
|
4,350
|
|
|
|
4,350
|
|
|
|
4,350
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
6,730
|
|
|
|
7,107
|
|
|
|
14,567
|
|
|
|
14,438
|
|
|
|
16,795
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INCOME (LOSS) FROM OPERATIONS
|
|
|
2,023
|
|
|
|
339
|
|
|
|
228
|
|
|
|
(761
|
)
|
|
|
(600
|
)
|
OTHER INCOME (EXPENSE):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Legal settlement
|
|
|
|
|
|
|
|
|
|
|
5,629
|
|
|
|
|
|
|
|
|
|
Interest and other income
|
|
|
149
|
|
|
|
140
|
|
|
|
284
|
|
|
|
324
|
|
|
|
416
|
|
Interest and other expense
|
|
|
(109
|
)
|
|
|
(199
|
)
|
|
|
(251
|
)
|
|
|
(5
|
)
|
|
|
(29
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INCOME (LOSS) BEFORE PROVISION FOR
FOREIGN INCOME TAXES
|
|
|
2,063
|
|
|
|
280
|
|
|
|
5,890
|
|
|
|
(442
|
)
|
|
|
(213
|
)
|
PROVISION FOR FOREIGN INCOME TAXES
|
|
|
(126
|
)
|
|
|
(91
|
)
|
|
|
(199
|
)
|
|
|
(175
|
)
|
|
|
(140
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCOME (LOSS)
|
|
|
1,937
|
|
|
|
189
|
|
|
|
5,691
|
|
|
|
(617
|
)
|
|
|
(353
|
)
|
OTHER COMPREHENSIVE
INCOME Foreign currency translation adjustment
|
|
|
10
|
|
|
|
36
|
|
|
|
66
|
|
|
|
(172
|
)
|
|
|
87
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE INCOME (LOSS)
|
|
$
|
1,947
|
|
|
$
|
225
|
|
|
$
|
5,757
|
|
|
$
|
(789
|
)
|
|
$
|
(266
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCOME (LOSS)
|
|
$
|
1,937
|
|
|
$
|
189
|
|
|
$
|
5,691
|
|
|
$
|
(617
|
)
|
|
$
|
(353
|
)
|
DIVIDENDS PAID OR DECLARED
|
|
|
(330
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,400
|
)
|
DISTRIBUTION OF MTC RETAINED
DEFICIT
|
|
|
70
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RETAINED EARNINGS (DEFICIT):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beginning of period
|
|
|
866
|
|
|
|
(4,825
|
)
|
|
|
(4,825
|
)
|
|
|
(4,208
|
)
|
|
|
(455
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
End of period
|
|
$
|
2,543
|
|
|
$
|
(4,636
|
)
|
|
$
|
866
|
|
|
$
|
(4,825
|
)
|
|
$
|
(4,208
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these combined financial statements.
F-43
MEDISYSTEMS
GROUP
COMBINED STATEMENTS OF CASH FLOWS
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended
|
|
|
For The Year Ended
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM OPERATING
ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
1,937
|
|
|
$
|
189
|
|
|
$
|
5,691
|
|
|
$
|
(617
|
)
|
|
$
|
(353
|
)
|
Adjustments to reconcile net
income (loss) to net cash provided by operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
418
|
|
|
|
452
|
|
|
|
917
|
|
|
|
1,069
|
|
|
|
1,366
|
|
Loss (gain) on disposal of
assets net
|
|
|
13
|
|
|
|
|
|
|
|
2
|
|
|
|
1
|
|
|
|
(23
|
)
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
trade
|
|
|
(189
|
)
|
|
|
(740
|
)
|
|
|
(3,249
|
)
|
|
|
1,722
|
|
|
|
(2,239
|
)
|
Accounts receivable
affiliates
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
other
|
|
|
5,876
|
|
|
|
201
|
|
|
|
(5,980
|
)
|
|
|
546
|
|
|
|
(196
|
)
|
Inventories
|
|
|
(814
|
)
|
|
|
1,046
|
|
|
|
(192
|
)
|
|
|
(1,023
|
)
|
|
|
(335
|
)
|
Other current assets
|
|
|
(257
|
)
|
|
|
(133
|
)
|
|
|
67
|
|
|
|
(65
|
)
|
|
|
135
|
|
Other assets
|
|
|
5
|
|
|
|
42
|
|
|
|
42
|
|
|
|
(10
|
)
|
|
|
(7
|
)
|
Accounts payable
|
|
|
562
|
|
|
|
1,094
|
|
|
|
1,212
|
|
|
|
(1,556
|
)
|
|
|
(606
|
)
|
Accounts payable
affiliates
|
|
|
(6,752
|
)
|
|
|
775
|
|
|
|
2,296
|
|
|
|
50
|
|
|
|
4,350
|
|
Accrued expenses
|
|
|
(773
|
)
|
|
|
(1,669
|
)
|
|
|
(64
|
)
|
|
|
469
|
|
|
|
328
|
|
Other liabilities
|
|
|
(12
|
)
|
|
|
53
|
|
|
|
60
|
|
|
|
(53
|
)
|
|
|
137
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in)
operating activities
|
|
|
14
|
|
|
|
1,310
|
|
|
|
802
|
|
|
|
533
|
|
|
|
2,557
|
|
F-44
MEDISYSTEMS
GROUP
COMBINED
STATEMENTS OF CASH FLOWS (Continued)
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended
|
|
|
For The Year Ended
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING
ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(705
|
)
|
|
|
(495
|
)
|
|
|
(1,796
|
)
|
|
|
(852
|
)
|
|
|
(746
|
)
|
Proceeds from sale of property and
equipment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing
activities
|
|
|
(705
|
)
|
|
|
(495
|
)
|
|
|
(1,796
|
)
|
|
|
(852
|
)
|
|
|
(722
|
)
|
CASH FLOWS FROM FINANCING
ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends paid
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,400
|
)
|
Bank overdrafts
|
|
|
|
|
|
|
(74
|
)
|
|
|
(74
|
)
|
|
|
74
|
|
|
|
|
|
Additional investment by
stockholder
|
|
|
|
|
|
|
|
|
|
|
123
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used) in
financing activities
|
|
|
|
|
|
|
(74
|
)
|
|
|
49
|
|
|
|
74
|
|
|
|
(3,400
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation
effect on cash flows
|
|
|
10
|
|
|
|
36
|
|
|
|
66
|
|
|
|
(172
|
)
|
|
|
87
|
|
NET INCREASE (DECREASE) IN CASH
AND CASH EQUIVALENTS
|
|
|
(681
|
)
|
|
|
(777
|
)
|
|
|
(879
|
)
|
|
|
(417
|
)
|
|
|
(1,478
|
)
|
CASH AND CASH EQUIVALENTS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beginning of year
|
|
|
1,622
|
|
|
|
2,501
|
|
|
|
2,501
|
|
|
|
2,918
|
|
|
|
4,396
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
End of year
|
|
$
|
941
|
|
|
$
|
3,278
|
|
|
$
|
1,622
|
|
|
$
|
2,501
|
|
|
$
|
2,918
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of
cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for
income taxes
|
|
|
73
|
|
|
|
106
|
|
|
|
288
|
|
|
|
217
|
|
|
|
322
|
|
Cash paid during the year for
interest
|
|
|
15
|
|
|
|
2
|
|
|
|
14
|
|
|
|
5
|
|
|
|
5
|
|
Supplemental disclosures of
non-cash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared
|
|
|
330
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spin-off of MTC
|
|
|
70
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these combined financial statements.
F-45
MEDISYSTEMS
GROUP
NOTES TO COMBINED FINANCIAL STATEMENTS
(Information as of June 30, 2007 and for the Six Months
Ended
June 30, 2007 and 2006 is Unaudited)
(Dollars in thousands)
|
|
1.
|
SIGNIFICANT
ACCOUNTING POLICIES
|
Nature of Operations Medisystems Group
companies are involved in the design, manufacture, assembly,
import, export, and distribution of disposable medical devices
primarily for use in dialysis and related blood therapies.
Certain members of the Medisystems Group represent contract
manufacturers that sell their products exclusively to other
members of the Medisystems Group.
Organization and Principles of Combination
The Medisystems Group is composed of various domestic and
foreign corporations that are related through common ownership,
management control, incorporation of certain technology used in
the manufacture of products and the interdependence of operating
activities. The Medisystems Group is under the common ownership
and management control of a sole stockholder who directly or
indirectly owns all of the outstanding stock of the Medisystems
Group.
The combined financial statements for the Medisystems Group
include the accounts of the following entities:
Medisystems Corporation, or MDS Originally
formed in the state of California in 1981 and subsequently
incorporated in the state of Washington in 1993, this subchapter
S corporation is involved in the design, import, and
distribution of the Medisystems Groups products.
MDSs principal location is in Seattle, Washington, with a
customer service office near Denver, Colorado. MDS owns
equipment located in Italy and Mexico that is utilized in the
manufacturing and assembly operations of other members of the
Medisystems Group.
Medisystems Technology Corporation, or MTC
Formed in 1998, this state of Nevada subchapter
S corporation receives all of its revenue from royalties
under the terms of license agreements with MDS. MTC in turn pays
license fees to DSU Medical under the terms of its license
agreement with DSU Medical, and is responsible for securing
intellectual property licenses for the components utilized in
the Medisystems Groups products. MTCs operations are
located in Las Vegas, Nevada. In May, 2007, MTC merged into DSU
Medical, another entity under the control of its sole
shareholder, Mr. Utterberg, with DSU Medical being the
surviving entity. The accounts of MTC are included in the
Medisystems Group through May 31, 2007, the date of merger.
The impact of removing MTC from the Medisystems Groups
financial statements was immaterial given all significant
accounts were inter-company in nature and, as such, were
eliminated in combination.
Medisystems Research Corporation, or MRC
Formed in 1995, this state of Illinois subchapter
S corporation performs research and development activities
aimed at developing new products and improvements to existing
products for the Medisystems Group. MRCs facility is
located near Chicago, Illinois.
Medisystems Services Corporation, or MSC
Formed in 1998, this state of Nevada subchapter
S corporation provides contract employee services
exclusively to other Medisystems Group companies. MSCs
operations are located in Las Vegas, Nevada.
Lifestream Medical Corporation, or LSM Formed
in 1996, this state of Nevada subchapter S corporation was
created in anticipation of the possible future reorganization of
the Medisystems Groups U.S. operations. LSM presently
has no operations of significance.
Infusion Care Services, Inc., or ICS Formed
in 1991 and without any activity or initial capitalization until
1997, this state of Delaware subchapter S corporation is
involved in specific product sourcing transactions. ICS
presently has no operations of significance.
F-46
MEDISYSTEMS
GROUP
NOTES TO
COMBINED FINANCIAL
STATEMENTS (Continued)
Medimexico, S. de R.L. de C.V., or MDM Formed
in 1993 and a subsidiary of MDS since 1998, this Mexican
corporation provides manufacturing and assembly services of
components and finished products to MDS under a Maquiladora
contract. All of MDMs production is sold to MDS under this
Maquiladora contract. In its operations, MDM utilizes certain
manufacturing and assembly equipment owned by MDS. MDMs
facility is located in Tijuana, Baja California, Mexico.
Medisystems Europe S.p.A., or MDE Formerly
known as Amtech, S.r.l. and formed in 1991, this Italian
corporation manufactures medical device components for MDS. All
of MDEs production is sold under a contract manufacturing
agreement to MDS for inclusion in its final product. In its
operations, MDE also utilizes certain manufacturing and assembly
equipment owned by MDS. MDEs facility is located in
Sorbara, Modena, Italy.
The commonality of ownership among the members of the
Medisystems Group as of June 30, 2007, and
December 31, 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007
|
|
|
December 31, 2006
|
|
|
|
Percent Owned
|
|
|
|
|
|
Percent Owned
|
|
|
|
|
|
|
by a Common
|
|
|
Remainder
|
|
|
by a Common
|
|
|
Remainder
|
|
Entity
|
|
Stockholder
|
|
|
Owned by
|
|
|
Stockholder
|
|
|
Owned by
|
|
|
MDS
|
|
|
100.0
|
%
|
|
|
N/A
|
|
|
|
100.0
|
%
|
|
|
N/A
|
|
MRC
|
|
|
100.0
|
|
|
|
N/A
|
|
|
|
100.0
|
|
|
|
N/A
|
|
MTC
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
100.0
|
|
|
|
N/A
|
|
MSC
|
|
|
100.0
|
|
|
|
N/A
|
|
|
|
100.0
|
|
|
|
N/A
|
|
LSM
|
|
|
100.0
|
|
|
|
N/A
|
|
|
|
100.0
|
|
|
|
N/A
|
|
ICS
|
|
|
100.0
|
|
|
|
N/A
|
|
|
|
100.0
|
|
|
|
N/A
|
|
MDM
|
|
|
0.3
|
|
|
|
MDS
|
|
|
|
0.3
|
|
|
|
MDS
|
|
MDE
|
|
|
90.0
|
|
|
|
MDS
|
|
|
|
90.0
|
|
|
|
MDS
|
|
The combined financial statements do not include the accounts of
DSU Medical, another entity under the control of the sole
shareholder of the Medisystems Group that owns intellectual
property licensed to MDS and provides consulting services to the
Medisystems Group. DSU Medical is not included in the combined
Medisystems Group since its activities are substantially
unrelated to the Medisystems Groups activities and revenue
generated from the Medisystems Group member companies is not
significant in relation to DSUs operating revenue and as
such, DSU Medical is not economically dependent on revenue from
the Medisystems Group. In May 2007, MTC merged into DSU Medical,
with DSU Medical being the surviving entity.
Unaudited Interim Financial Information
The accompanying interim combined balance sheet as of
June 30, 2007, the combined statements of income,
comprehensive income (loss), and retained earnings (deficit) and
of cash flows for the six months ended June 30, 2007 and
2006 are unaudited. The unaudited interim combined statements
have been prepared in accordance with U.S. Generally
Accepted Accounting Principles, or GAAP, and in the opinion of
the Medisystems Groups management have been prepared on
the same basis as the audited combined financial statements as
of and for the year ended December 31, 2006, 2005 and 2004
and include all adjustments, consisting of normal recurring
adjustments and accruals, necessary for the fair presentation of
the Medisystems Groups financial position at June 30,
2007 and its results of operations and its cash flows for the
six months ended June 30, 2007 and 2006. The results for
the six months ended June 30, 2007 are not necessarily
indicative of the results to be expected for the year ending
December 31, 2007.
Use of Estimates The preparation of
financial statements in conformity with GAAP requires management
to make estimates and assumptions that affect amounts reported
in the combined financial statements and accompanying notes. The
most significant estimates relate to future customer rebates,
sales returns,
F-47
MEDISYSTEMS
GROUP
NOTES TO
COMBINED FINANCIAL
STATEMENTS (Continued)
inventory obsolescence, depreciation and useful lives of
depreciable assets. Actual results could differ from those
estimates.
Cash Equivalents Short-term
investments with an original maturity of three months or less
are considered to be cash equivalents. Cash equivalents are
carried at cost, which approximates market value. Approximately
$587,000, $454,000 and $510,000 was deposited with foreign banks
at June 30, 2007, December 31, 2006 and 2005,
respectively.
Trade Accounts Receivable Trade
accounts receivable are stated at the amount the Medisystems
Group expects to collect. The Medisystems Group maintains
allowances for doubtful accounts for estimated losses resulting
from the inability of its customers to make required payments.
The Medisystems Group management considers the following factors
when determining the collectibility of specific customer
accounts: customer credit-worthiness, past transaction history
with the customer, current economic industry trends, and changes
in customer payment terms and the length of time the receivable
is past due. Based on the Medisystems Group managements
assessment, the Medisystems Group provides for estimated
uncollectible amounts through a charge to earnings and a credit
to a valuation allowance. Balances that remain outstanding after
the Medisystems Group has used reasonable collection efforts are
written off through a charge to the valuation allowance and a
credit to accounts receivable.
Fair Value of Financial Instruments
The carrying value for cash, cash equivalents, accounts
receivable and accounts payable approximates fair value because
of the short maturity of these instruments.
Other Receivables Other receivables
consist primarily of advanced deposits with customers,
refundable value-added tax payments in Italy and Mexico,
refundable income tax payments and proceeds from legal
settlement. A lawsuit for patent infringement was settled in
December 2006 and proceeds of $5,629,000 were outstanding at
December 31, 2006 and received in February 2007 and are
included in other income for the year ended December 31,
2006.
Inventories Inventories are stated at
the lower of cost
(first-in,
first-out basis) or market.
Property, Equipment and Leasehold
Improvements Property, equipment and
leasehold improvements are stated at cost, less accumulated
depreciation. Depreciation for property and equipment is
calculated primarily on a straight-line basis over the estimated
useful lives of the related assets, ranging from 3 to
15 years. Depreciation for leasehold improvements is
calculated primarily on a straight-line basis over the estimated
useful life of the asset or over the remaining portion of the
lease, whichever is less.
Long-Lived Assets Management
periodically reevaluates long-lived assets consisting primarily
of property, equipment, and leasehold improvements to determine
whether there has been any impairment of the value of these
assets and the appropriateness of their estimated remaining
lives. No such impairment was recognized as of June 30,
2007, December 31, 2006 and 2005, respectively.
Revenue Recognition The Medisystems
Group recognizes revenue when persuasive evidence of an
arrangement exists, delivery has occurred, the sales price is
fixed and determinable, and collectibility is reasonably
assured. The Medisystems Group sells its goods based on terms
which define transfer of title and risk of loss at a specific
location, typically FOB destination. In addition, the
Medisystems Group periodically evaluates whether an allowance
for sales returns is necessary. Historically, the level of
returns has been insignificant.
Customer Rebates Customer rebates are
accounted for under the provisions of
EITF 01-09
Accounting for Consideration Given by a Vendor to a
Customer (Including a Reseller of the Vendors
Products). The amount of future rebates on applicable
sales is estimated based on factors such as estimated inventory
on hand with distributors, historical volume of rebates and the
terms of rebate agreements. Customer rebates are included as a
reduction of sales and accounts receivable.
F-48
MEDISYSTEMS
GROUP
NOTES TO
COMBINED FINANCIAL
STATEMENTS (Continued)
Significant Customers The Medisystems
Groups sales are concentrated among a few large customers,
distributors and NxStage. For the six months ended June 30,
2007 and 2006 and the years ended December 31, 2006, 2005,
and 2004, the percentage of sales to these customers is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the
|
|
|
|
|
|
|
six months
|
|
|
|
|
|
|
ending
|
|
|
For the year ending
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
Customer #1
|
|
|
66
|
%
|
|
|
66
|
%
|
|
|
65
|
%
|
|
|
66
|
%
|
|
|
61
|
%
|
Customer #2
|
|
|
11
|
|
|
|
20
|
|
|
|
17
|
|
|
|
23
|
|
|
|
29
|
|
Customer #3
|
|
|
11
|
|
|
|
4
|
|
|
|
7
|
|
|
|
2
|
|
|
|
1
|
|
Customer #4
|
|
|
7
|
|
|
|
7
|
|
|
|
8
|
|
|
|
7
|
|
|
|
2
|
|
All other customers
|
|
|
5
|
|
|
|
3
|
|
|
|
3
|
|
|
|
2
|
|
|
|
7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100
|
%
|
|
|
100
|
%
|
|
|
100
|
%
|
|
|
100
|
%
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Medisystems Group sells to its largest customers under
long-term supply contracts that are subject to renewal at
various dates in future years. The contract with the third
largest customer expired in February 2007 and was not renewed by
Medisystems. Remaining contracts expire on various dates through
January 2014. Under the terms of the long-term contracts,
customers are required to purchase certain minimum quantities
that increase yearly throughout the contract period.
The accounts receivable balances consist primarily of
receivables from these significant customers. Sales are made
without collateral, and the Medisystems Groups
credit-related losses have been insignificant. The percentage of
receivables for customers #1, #2, and #3 were
25%, 42% and 22% as of June 30, 2007, 16%, 42% and 23%, as
of December 31, 2006 and 0%, 47% and 18%, as of
December 31, 2005, respectively.
Greater than 98% of the Medisystems Groups sales for each
period presented were made to customers located in the United
States of America.
Vendors The Medisystems Group
purchases a majority of its bloodlines and substantially all of
its needle sets from Kawasumi Laboratories, Inc., a Japanese
contract manufacturer. This purchase arrangement is covered by
formal contracts expiring in June 2008 for bloodlines and
February 2011 for needle sets. At June 30, 2007,
December 31, 2006 and 2005, approximately $7,562,000,
$7,756,000 and $7,943,000, respectively, was owed to this
supplier and is included in accounts payable and accrued
expenses.
Under the terms of the manufacturing agreement, the Medisystems
Group agrees to purchase from this supplier an annual quantity
at least equal to 80% of the goals established by both parties
for each 12 month period commencing February 1. The
Medisystems Group has not experienced any losses as a result of
this commitment and does not expect any losses over the
remaining term of this annual agreement. If the parties cannot
agree on new goals for an upcoming year at least 4 months
prior to the start of the contract year, the agreement will be
terminated at the conclusion of such contract year.
Shipping and Handling The Medisystems
Groups shipping and handling costs are included in cost of
sales for all periods presented. Freight charged to customers is
included in net sales.
Foreign Currency Translation Assets
and liabilities of Medisystems Groups foreign operations
are translated into US Dollars at the exchange rate in
effect at the balance sheet date. Revenue and expenses are
translated at average rates in effect during the period. The
resulting translation adjustment is reflected as accumulated
Other Comprehensive Income, a separate component of
Stockholders Equity. Realized and unrealized gains
(losses) on foreign currency transactions are included in Other
Income (Expense). The Medisystems Group recognized $10,000
and $36,000 of foreign exchange translation gains for the six
months ended June 30, 2007 and 2006, respectively, and
$66,000, ($172,000) and $87,000 of foreign exchange
F-49
MEDISYSTEMS
GROUP
NOTES TO
COMBINED FINANCIAL
STATEMENTS (Continued)
transaction gains (losses) for the years ended December 31,
2006, 2005 and 2004, respectively, which are included in Other
Income in the combined Statement of Income.
Research and Development Costs
Research and development costs are charged to operations as
incurred.
Income Taxes MDS, MRC, MTC, MSC, LSM
and ICS are subchapter S corporations for federal income
tax purposes. Accordingly, the companies taxable income or
loss is reported on their sole shareholders personal tax
return, and no provision for income tax is reflected in these
financial statements.
The Medisystems Group accounts for foreign income taxes under
the asset and liability method whereby deferred income taxes are
recorded for the temporary differences between the amounts of
assets and liabilities for financial reporting purposes and
amounts as measured for tax purposes.
Comprehensive Income (Loss)
Comprehensive income (loss) consists of net income (loss)
and other comprehensive income (loss). Other comprehensive
income (loss) includes certain changes in equity, such as
foreign currency translation adjustments, that are excluded from
results of operations.
Reclassifications Certain
reclassifications were made to prior periods to conform to
current year presentation.
New Accounting Pronouncements On
November 24, 2004, the FASB issued Statement No. 151
(FAS 151), Inventory Costs, an amendment of ARB
No. 43, Chapter 4 which clarifies the accounting for
abnormal amounts of idle facility expense, freight handling
costs and wasted material. FAS 151 requires that abnormal
items be recognized as current-period charges, as well as
unallocated overheads recognized in the period in which they are
incurred. The provisions of this statement are effective for
costs incurred during fiscal periods beginning after
June 15, 2005. The adoption of this statement on
January 1, 2006 had no impact to the Medisystems
Groups financial statements.
Inventories consist of the following at June 30, 2007 and
at December 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
(Dollars in thousands)
|
|
|
Raw materials
|
|
$
|
4,003
|
|
|
$
|
3,165
|
|
|
$
|
2,856
|
|
Work in progress
|
|
|
597
|
|
|
|
476
|
|
|
|
510
|
|
Finished goods
|
|
|
4,068
|
|
|
|
4,213
|
|
|
|
4,296
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
8,668
|
|
|
$
|
7,854
|
|
|
$
|
7,662
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-50
MEDISYSTEMS
GROUP
NOTES TO
COMBINED FINANCIAL
STATEMENTS (Continued)
|
|
3.
|
PROPERTY,
EQUIPMENT, AND LEASEHOLD IMPROVEMENTS
|
Property, equipment, and leasehold improvements are physically
located in various countries and consist of the following at
June 30, 2007 and at December 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007
|
|
Italy
|
|
|
Mexico
|
|
|
United States
|
|
|
Total
|
|
|
|
(Dollars in thousands)
|
|
|
Machinery and equipment
|
|
$
|
9,923
|
|
|
$
|
6,244
|
|
|
$
|
887
|
|
|
$
|
17,054
|
|
Furniture and fixtures
|
|
|
290
|
|
|
|
299
|
|
|
|
561
|
|
|
|
1,150
|
|
Leasehold improvements
|
|
|
1,715
|
|
|
|
2,419
|
|
|
|
473
|
|
|
|
4,607
|
|
Vehicles
|
|
|
97
|
|
|
|
57
|
|
|
|
|
|
|
|
154
|
|
Computer software &
hardware
|
|
|
781
|
|
|
|
692
|
|
|
|
1,550
|
|
|
|
3,023
|
|
Equipment under construction
|
|
|
301
|
|
|
|
302
|
|
|
|
|
|
|
|
603
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
13,107
|
|
|
|
10,013
|
|
|
$
|
3,471
|
|
|
$
|
26,591
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less accumulated depreciation and
amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,865
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
3,726
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006
|
|
Italy
|
|
|
Mexico
|
|
|
United States
|
|
|
Total
|
|
|
|
(Dollars in thousands)
|
|
|
Machinery and equipment
|
|
$
|
9,368
|
|
|
$
|
6,527
|
|
|
$
|
909
|
|
|
$
|
16,804
|
|
Furniture and fixtures
|
|
|
281
|
|
|
|
299
|
|
|
|
561
|
|
|
|
1,141
|
|
Leasehold improvements
|
|
|
1,035
|
|
|
|
2,419
|
|
|
|
473
|
|
|
|
3,927
|
|
Vehicles
|
|
|
95
|
|
|
|
47
|
|
|
|
|
|
|
|
142
|
|
Computer software &
hardware
|
|
|
799
|
|
|
|
692
|
|
|
|
1,550
|
|
|
|
3,041
|
|
Equipment under construction
|
|
|
738
|
|
|
|
37
|
|
|
|
2
|
|
|
|
777
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
12,316
|
|
|
$
|
10,021
|
|
|
$
|
3,495
|
|
|
$
|
25,832
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less accumulated depreciation and
amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,382
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
3,450
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005
|
|
Italy
|
|
|
Mexico
|
|
|
United States
|
|
|
Total
|
|
|
|
(Dollars in thousands)
|
|
|
Machinery and equipment
|
|
$
|
8,486
|
|
|
$
|
6,859
|
|
|
$
|
1,208
|
|
|
$
|
16,553
|
|
Furniture and fixtures
|
|
|
245
|
|
|
|
299
|
|
|
|
561
|
|
|
|
1,105
|
|
Leasehold improvements
|
|
|
928
|
|
|
|
2,419
|
|
|
|
473
|
|
|
|
3,820
|
|
Vehicles
|
|
|
86
|
|
|
|
47
|
|
|
|
|
|
|
|
133
|
|
Computer software
|
|
|
282
|
|
|
|
181
|
|
|
|
1,047
|
|
|
|
1,510
|
|
Equipment under construction
|
|
|
611
|
|
|
|
9
|
|
|
|
121
|
|
|
|
741
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
10,638
|
|
|
$
|
9,814
|
|
|
$
|
3,410
|
|
|
$
|
23,862
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less accumulated depreciation and
amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,289
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
2,573
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense for the six months ended June 30, 2007
and 2006 was $418,000 and $452,000, respectively. Depreciation
expense for the years ended December 31, 2006, 2005 and
2004 was $917,000, $1,069,000 and $1,366,000, respectively.
F-51
MEDISYSTEMS
GROUP
NOTES TO
COMBINED FINANCIAL
STATEMENTS (Continued)
|
|
4.
|
NONCURRENT
LIABILITIES
|
Noncurrent liabilities consisted of the following at
June 30, 2007 and December 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
(Dollars in thousands)
|
|
|
Future severance payable under
Italian law
|
|
$
|
716
|
|
|
$
|
689
|
|
|
$
|
570
|
|
Deferred Rent
|
|
|
34
|
|
|
|
73
|
|
|
|
132
|
|
Lease deposits
|
|
|
23
|
|
|
|
23
|
|
|
|
23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
773
|
|
|
$
|
785
|
|
|
$
|
725
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Medisystems Group has noncancellable operating leases for
research and development facilities, manufacturing and assembly
facilities and corporate offices. The research facility is
located in the United States. The lease expires in 2007 with an
option to renew for two additional two-year extensions. The
manufacturing and assembly facilities are located in Mexico and
Italy. The Mexico facility lease expires through 2011 with
various renewal options to extend through 2016. The Italy
facility lease expires through 2012 with various renewal options
to extend through 2018. The Medisystems Group also has lease
commitments for corporate offices in the United States. These
leases expire through 2007 and have five-year renewal options.
The Medisystems Group has also subleased excess office space
through 2007. The Medisystems Group is also required to pay
taxes, insurance, and repairs and maintenance on the majority of
its facility and office leases.
Rent expense net of sublease income under the operating leases
for the six months ended June 30, 2007 and 2006 totaled
$707,000 and $685,000 respectively, and for the year ended
December 31, 2006, 2005 and 2004 totaled $1,316,000,
$1,268,000 and $1,303,000, respectively. Minimum future rental
payments required under the lease agreements are as follows at
December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sublease
|
|
|
|
|
|
|
MRC
|
|
|
MDE
|
|
|
MDM
|
|
|
MDS
|
|
|
Income
|
|
|
Total
|
|
|
2007
|
|
|
35
|
|
|
|
125
|
|
|
|
677
|
|
|
|
688
|
|
|
|
(170
|
)
|
|
|
1,355
|
|
2008
|
|
|
|
|
|
|
127
|
|
|
|
697
|
|
|
|
|
|
|
|
|
|
|
|
824
|
|
2009
|
|
|
|
|
|
|
130
|
|
|
|
718
|
|
|
|
|
|
|
|
|
|
|
|
848
|
|
2010
|
|
|
|
|
|
|
133
|
|
|
|
739
|
|
|
|
|
|
|
|
|
|
|
|
872
|
|
2011
|
|
|
|
|
|
|
135
|
|
|
|
567
|
|
|
|
|
|
|
|
|
|
|
|
702
|
|
Thereafter
|
|
|
|
|
|
|
49
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
49
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Minimum future payments, net
|
|
$
|
35
|
|
|
$
|
699
|
|
|
|
3,398
|
|
|
$
|
688
|
|
|
$
|
(170
|
)
|
|
$
|
4,650
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6.
|
EMPLOYEE
BENEFIT PLANS
|
The Medisystems Group maintains a qualified defined contribution
401(k) profit sharing plan, or the Plan, covering
U.S. domiciled employees of MDS, MRC and MSC. The Plan
covers substantially all employees upon date of hire.
Participants vest in the Groups contributions ratably over
six years. The Plan allows for employee contributions of up to
the annual Internal Revenue Service, or the IRS, maximum
deferral amount. Employee contributions to the Plan are matched
by MDS, MRC and MSC at a rate of 50% of the employees
contributions. These employer contributions are limited to an
annual maximum of 3% of the employees base pay. Employer
contributions for the six months ended June 30, 2007 and
2006 totaled $27,000 and $47,000 respectively, and for the year
ended December 31, 2006, 2005 and 2004 totaled $85,000,
F-52
MEDISYSTEMS
GROUP
NOTES TO
COMBINED FINANCIAL
STATEMENTS (Continued)
$77,000 and $75,000, respectively. In addition, the Medisystems
Group made a discretionary profit sharing contribution in the
amount of $208,000, $99,000 and $154,000 in 2006, 2005 and 2004
respectively.
Italian law provides for severance payments to employees upon
dismissal, resignation, retirement or other termination of
employment. Accruals are computed as of the date of the
financial statements based upon category of personnel, length of
service with the Medisystems Group, cost of living index and
compensation. Accruals are charged directly to income and are
not funded. Amounts payable at June 30, 2007 of $716,000
and at December 31, 2006 and 2005 of $689,000 and $570,000,
respectively, are included in non-current liabilities.
|
|
7.
|
RELATED
PARTY TRANSACTIONS
|
The underlying technology included in the products and
components produced by the Medisystems Group are covered by
patents developed and owned by DSU Medical, a separate company
owned by the Medisystems Groups sole stockholder, but not
included in the Medisystems Groups combined financial
statements. Through a series of license and sublicense
agreements executed in 1998, DSU Medical granted MTC a
nonexclusive license to this technology, which in turn granted a
nonexclusive sublicense to the technology to MDS. The sublicense
agreement, with an effective date of October 1, 1998, calls
for annual royalty payments from MDS of $5,700,000, payable in
quarterly installments, in advance. During April 2001, both the
license and sublicense agreements were amended to grant
exclusive right and license to practice the inventions of
certain subject patents referenced in the original license and
sublicense agreements. These amendments also increased the
annual royalty payment from MDS under the sublicense agreement
from $5,700,000 to $5,800,000. The license agreement, also dated
October 1, 1998, requires MTC to pay a royalty to DSU
Medical in an amount ranging from 75% to 100% of any sublicense
royalties received by MTC.
For the period January 1, 2007 through May 31, 2007,
at the discretion of the sole stockholder and in contemplation
of renegotiation of existing agreements, DSU Medical did not
charge royalty payments to MTC and MTC, in turn, did not charge
royalty to MDS.
Effective June 1, 2007, DSU Medical and MDS terminated the
royalty sublicense agreement to MDS for consideration of
$2,661,000 to be paid to DSU Medical. A new, royalty free
license agreement between DSU Medical and MDS was entered into
effective June 1, 2007.
As of and for the six months ended June 30, 2007,
under these license and royalty agreements, MDS incurred royalty
expense of $2,661,000 in consideration of termination of the
royalty-bearing sublicense agreement and establishment of the
royalty-free license agreement and owed $4,494,000 payable to
DSU Medical.
As of and for the period ended December 31, 2006, under
these license and royalty agreements, MDS incurred royalty
expense of $5,800,000 and owed $5,806,000 payable to MTC, and
MTC incurred royalty expense of $4,350,000 but owed $11,150,000
payable to DSU Medical.
As of and for the period ended December 31, 2005, under
these license and royalty agreements, MDS incurred royalty
expense of $5,800,000 and owed $12,650,000 payable to MTC, and
MTC incurred royalty expense of $4,350,000 and owed $8,750,000
payable to DSU Medical.
As of and for the period ended December 31, 2004, under
these license and royalty agreements, MDS incurred royalty
expense of $5,800,000 and owed $11,150,000 payable to MTC and
MTC incurred royalty expense of $4,350,000 and owed $8,700,000
payable to DSU Medical.
All royalty amounts paid and received between MDS and MTC under
their sublicense agreement have been eliminated in the
accompanying financial statements.
F-53
MEDISYSTEMS
GROUP
NOTES TO
COMBINED FINANCIAL
STATEMENTS (Continued)
The Medisystems Group has an amount payable to DSU Medical of
$45,000 at June 30, 2007 and $121,000 at December 31,
2006 for reimbursement of travel expenses paid on behalf of MDS
during 2006.
The Medisystems Group has an amount payable to
Mr. Utterberg of $0 and $55,000 at June 30, 2007 and
December 31, 2006, respectively, and an amount receivable
from Mr. Utterberg of $83,000 at December 31, 2005.
The Medisystems Group made sales of $3,682,000 and $1,260,000
for the six months ended June 30, 2007 and 2006,
respectively, and $4,560,000, $1,042,000 and $277,000 for the
years ended December 31, 2006, 2005 and 2004, respectively
to NxStage Medical, Inc., or NxStage, which is partly owned by
Mr. Utterberg, the sole stockholder of the Medisystems
Group. The accounts receivable balance from NxStage as of
June 30, 2007 was $906,000 and as of December 31, 2006
and 2005 was $1,056,000 and $256,000, respectively.
MDM and MDE are subject to taxation on income in their
respective countries. For the six months ended June 30,
2007 and 2006, the provision for foreign income taxes for MDM
was $31,000 and $38,000, respectively, and for MDE was $95,000
and $53,000, respectively. For the year ended December 31,
2006, 2005 and 2004 the provision for foreign income taxes for
MDM was $70,000, $12,000 and ($50,000), respectively, and for
MDE was $129,000 and $163,000 and $190,000, respectively.
Deferred income tax assets or liabilities, related to MDM and
MDE, consist predominantly of the temporary differences between
the tax basis of equipment and leasehold improvements and the
corresponding financial statement amounts. As of June 30,
2007 and December 31, 2006 and 2005, MDM had total deferred
tax assets of $173,000, $173,000 and $194,000, respectively, and
MDE had net deferred tax liabilities of $28,000, $28,000 and
$26,000 as of June 30, 2007, December 31, 2006 and
December 31, 2005, respectively.
The capital stock of the Medisystems Group at June 30, 2007
and at December 31, 2006 and 2005 is as follows:
June 30,
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
Medisystems Corporation, no par
value authorized, 100,000 shares; issued and
outstanding, 5,500 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Medisystems Research Corporation,
no par value authorized, 100,000 shares; issued
and outstanding, 5,000 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Medisystems Services Corporation,
no par value authorized, 25,000 shares; issued
and outstanding, 5,000 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Lifestream Medical Corporation, no
par value authorized, 5,000 shares; issued and
outstanding, 5,000 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Infusion Care Services, Inc., no
par value authorized, 1,000 shares; issued and
outstanding, 1,000 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Medimexico, S. de R.L. de C.V.,
one equity participation of fixed stock capital with a value of
$45,000 Mexican pesos
|
|
|
|
|
|
|
|
|
|
|
|
|
Medisystems Europe, S.p.A., par
value, 1.00 per share; issued and outstanding,
93,132 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
F-54
MEDISYSTEMS
GROUP
NOTES TO
COMBINED FINANCIAL
STATEMENTS (Continued)
December 31,
2006 and 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
Medisystems Corporation, no par
value authorized, 100,000 shares; issued and
outstanding, 5,500 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Medisystems Research Corporation,
no par value authorized, 100,000 shares; issued
and outstanding, 5,000 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Medisystems Technology
Corporation, no par value authorized,
25,000 shares; issued and outstanding, 5,000 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Medisystems Services Corporation,
no par value authorized, 25,000 shares; issued
and outstanding, 5,000 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Lifestream Medical Corporation, no
par value authorized, 5,000 shares; issued and
outstanding, 5,000 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Infusion Care Services, Inc., no
par value authorized, 1,000 shares; issued and
outstanding, 1,000 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Medimexico, S. de R.L. de C.V.,
one equity participation of fixed stock capital with a value of
$45,000 Mexican pesos
|
|
|
|
|
|
|
|
|
|
|
|
|
Medisystems Europe, S.p.A., par
value, 1.00 per share; issued and outstanding,
93,132 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
During 2006, Mr. Utterberg, the sole shareholder of
Lifestream Medical Corporation and Infusion Care Service Inc.
contributed capital of $125,000 and $8,000, respectively.
In January 2003, the Medisystems Group secured a $10,000,000
credit commitment from KeyBank National Association, or the
Bank, expiring January 31, 2006. The commitment consisted
of an $8,500,000 revolving line of credit and a $1,500,000
letter of credit facility. Through amendments in December 2003
and August 2004, the Bank reduced its combined credit commitment
to the Medisystems Group to $5,000,000, consisting of a
$3,500,000 revolving line of credit and a $1,500,000 demand line
of credit. The agreement was renewed in January 2006 and will
expire January 2009. The interest on outstanding borrowings is
equal to a Prime-Based Rate (minus 0.75%) or a London Inter-Bank
Offered Rate, or LIBOR, Based Rate (plus 1.75%) depending on
whether a LIBOR Rate Election has been made in accordance with
provisions of the respective Promissory Notes supporting the
Credit Loan Agreement. Prime rate at June 30, 2007 and at
December 31, 2006 was 8.25% and the LIBOR range was 5.3195%
for 1 month to 5.4256% for 12 months at June 30,
2007 and was 5.3256% for 1 month to 5.32938% for
12 months at December 31, 2006, according to published
sources. As of June 30, 2007, there were no outstanding
amounts due under the revolving line of credit. The accounts
receivable, inventory, and property of the Medisystems Group
have been pledged as collateral for the aforementioned credit
commitment. As of June 30, 2007, the Medisystems Group had
issued 781,000 ($1,056,000) of standby letters of credit
expiring through December 2010.
At June 30, 2007 and December 31, 2006, MDE had three
separate working capital lines of credit from two Italian banks
totaling 432,000 ($584,000) and 432,000 ($570,000),
respectively, and bearing interest ranging from 8.85% to 11.625%
at June 30, 2007 and 8.35% to 11.125% at December 31,
2006. The lines of credit have no stated expiration. There were
no amounts outstanding under these lines of credit as of
June 30, 2007 and December 31, 2006. MDE had one loan
outstanding as of June 30, 2007 totaling 173,000
($234,000) and as of December 31, 2006 totaling
191,000 ($252,000) which expires in September, 2011 and is
included in accrued liabilities. The interest on outstanding
borrowings is equal to EURIBOR for 3 months (plus 1.15%),
subject to an interest rate swap agreement at rates greater than
4%. When EURIBOR (3 months) plus 1.15% exceeds 4%, interest
is calculated on a blended basis, with 50% of the nominal value
of the loan subject to a fixed rate of 4%, and the remaining 50%
subject to the EURIBOR (3 months) plus 1.15%,
F-55
MEDISYSTEMS
GROUP
NOTES TO
COMBINED FINANCIAL
STATEMENTS (Continued)
EURIBOR for six months at June 30, 2007 and
December 31, 2006 was 4.175% and 3.725%, respectively,
according to published sources. Interest expense reflects the
applied blended interest rate calculation.
The Medisystems Group had total commitments to purchase capital
assets of approximately $519,000 at June 30, 2007 and
$414,000 at December 31, 2006.
In June 2007, the common stockholder of the Medisystems Group
entered into an agreement with NxStage, pursuant to which
NxStage has agreed to purchase the issued and outstanding shares
of MDS, MSC, MDE and MDM. The transaction is expected to close
in 2007.
F-56
ANNEX
A
STOCK
PURCHASE AGREEMENT, AS AMENDED
STOCK
PURCHASE AGREEMENT
BETWEEN
DAVID S. UTTERBERG
AND
NXSTAGE MEDICAL, INC.
June 4, 2007
TABLE OF
CONTENTS
|
|
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|
|
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|
Page
|
|
ARTICLE I PURCHASE AND SALE
OF THE SHARES
|
|
|
A-1
|
|
|
1.1
|
|
|
Purchase of the Shares from the
Stockholder
|
|
|
A-1
|
|
|
1.2
|
|
|
Further Assurances
|
|
|
A-1
|
|
|
1.3
|
|
|
Purchase Price
|
|
|
A-1
|
|
|
1.4
|
|
|
Payment of Base Purchase Price
|
|
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A-2
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|
|
1.5
|
|
|
Post-Closing Adjustments
|
|
|
A-2
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|
|
1.6
|
|
|
Escrow Account
|
|
|
A-4
|
|
|
1.7
|
|
|
The Closing
|
|
|
A-4
|
|
|
1.8
|
|
|
Stock Transfer Documents
|
|
|
A-4
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|
|
1.9
|
|
|
Allocation
|
|
|
A-4
|
|
|
|
|
|
|
ARTICLE II REPRESENTATIONS OF
THE STOCKHOLDER REGARDING THE SHARES
|
|
|
A-5
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|
|
2.1
|
|
|
Title
|
|
|
A-5
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|
|
2.2
|
|
|
Authority
|
|
|
A-5
|
|
|
2.3
|
|
|
Noncontravention
|
|
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A-5
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|
|
2.4
|
|
|
Approvals
|
|
|
A-5
|
|
|
2.5
|
|
|
Brokers
|
|
|
A-5
|
|
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2.6
|
|
|
Residency
|
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|
A-5
|
|
|
|
|
|
|
ARTICLE III REPRESENTATIONS
AND WARRANTIES OF THE STOCKHOLDER REGARDING THE COMPANIES
|
|
|
A-6
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|
|
3.1
|
|
|
Organization, Qualification and
Corporate Power
|
|
|
A-6
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|
|
3.2
|
|
|
Capitalization
|
|
|
A-6
|
|
|
3.3
|
|
|
Authorization of Transaction
|
|
|
A-7
|
|
|
3.4
|
|
|
[Intentionally Deleted]
|
|
|
A-7
|
|
|
3.5
|
|
|
Subsidiaries
|
|
|
A-7
|
|
|
3.6
|
|
|
Financial Statements
|
|
|
A-7
|
|
|
3.7
|
|
|
Absence of Certain Changes
|
|
|
A-7
|
|
|
3.8
|
|
|
Undisclosed Liabilities
|
|
|
A-7
|
|
|
3.9
|
|
|
Tax Matters
|
|
|
A-8
|
|
|
3.10
|
|
|
Assets
|
|
|
A-10
|
|
|
3.11
|
|
|
Owned Real Property
|
|
|
A-10
|
|
|
3.12
|
|
|
Real Property Leases
|
|
|
A-10
|
|
|
3.13
|
|
|
Intellectual Property
|
|
|
A-10
|
|
|
3.14
|
|
|
Inventory
|
|
|
A-12
|
|
|
3.15
|
|
|
Contracts
|
|
|
A-13
|
|
|
3.16
|
|
|
Accounts Receivable
|
|
|
A-14
|
|
|
3.17
|
|
|
Powers of Attorney
|
|
|
A-14
|
|
|
3.18
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|
|
Insurance
|
|
|
A-14
|
|
|
3.19
|
|
|
Litigation
|
|
|
A-14
|
|
|
3.20
|
|
|
Warranties
|
|
|
A-15
|
|
|
3.21
|
|
|
Employees
|
|
|
A-15
|
|
|
3.22
|
|
|
Employee Benefits
|
|
|
A-16
|
|
|
3.23
|
|
|
Environmental Matters
|
|
|
A-17
|
|
|
3.24
|
|
|
Legal Compliance
|
|
|
A-18
|
|
|
3.25
|
|
|
Customers and Suppliers
|
|
|
A-19
|
|
|
3.26
|
|
|
Permits
|
|
|
A-20
|
|
A-i
|
|
|
|
|
|
|
|
|
|
|
|
|
Page
|
|
|
3.27
|
|
|
Certain Business Relationships
With Affiliates
|
|
|
A-20
|
|
|
3.28
|
|
|
Brokers Fees
|
|
|
A-20
|
|
|
3.29
|
|
|
Books and Records
|
|
|
A-20
|
|
|
3.30
|
|
|
Disclosure
|
|
|
A-20
|
|
|
3.31
|
|
|
Controls and Procedures
|
|
|
A-20
|
|
|
3.32
|
|
|
[Intentionally Deleted]
|
|
|
A-21
|
|
|
3.33
|
|
|
Government Contracts
|
|
|
A-21
|
|
|
3.34
|
|
|
Questionable Payments
|
|
|
A-21
|
|
|
3.35
|
|
|
Personally Identifiable
Information and Privacy
|
|
|
A-21
|
|
|
3.36
|
|
|
Customs Matters
|
|
|
A-21
|
|
|
|
|
|
|
ARTICLE IV REPRESENTATIONS
AND WARRANTIES OF THE BUYER
|
|
|
A-22
|
|
|
4.1
|
|
|
Organization, Standing and Power
|
|
|
A-22
|
|
|
4.2
|
|
|
Capitalization
|
|
|
A-22
|
|
|
4.3
|
|
|
Authority; No Conflict; Required
Filings and Consents
|
|
|
A-23
|
|
|
4.4
|
|
|
Reports and Financial Statements
|
|
|
A-24
|
|
|
4.5
|
|
|
Absence of Certain Changes
|
|
|
A-24
|
|
|
|
|
|
|
ARTICLE V COVENANTS
|
|
|
A-24
|
|
|
5.1
|
|
|
Closing Efforts
|
|
|
A-24
|
|
|
5.2
|
|
|
Governmental and Third-Party
Notices and Consents
|
|
|
A-24
|
|
|
5.3
|
|
|
Special Meeting,
S-4
Registration Statement and Proxy Statement Prospectus
|
|
|
A-25
|
|
|
5.4
|
|
|
Operation of Business
|
|
|
A-25
|
|
|
5.5
|
|
|
Access to Information
|
|
|
A-26
|
|
|
5.6
|
|
|
Notice of Stockholder Changes
|
|
|
A-27
|
|
|
5.7
|
|
|
Exclusivity
|
|
|
A-27
|
|
|
5.8
|
|
|
Expenses
|
|
|
A-27
|
|
|
5.9
|
|
|
Listing of Buyer Shares
|
|
|
A-27
|
|
|
5.10
|
|
|
S-X Financial Statements
|
|
|
A-27
|
|
|
5.11
|
|
|
FIRPTA Tax Certificates
|
|
|
A-28
|
|
|
5.12
|
|
|
[Assignment and] License of IP
|
|
|
A-28
|
|
|
5.13
|
|
|
Notice of Buyer Changes
|
|
|
A-28
|
|
|
5.14
|
|
|
Elimination of Certain Items
|
|
|
A-28
|
|
|
5.15
|
|
|
Releases
|
|
|
A-29
|
|
|
|
|
|
|
ARTICLE VI CONDITIONS TO
CONSUMMATION OF THE TRANSACTIONS
|
|
|
A-29
|
|
|
6.1
|
|
|
Conditions to Obligation of the
Buyer
|
|
|
A-29
|
|
|
6.2
|
|
|
Conditions to Obligation of the
Stockholder
|
|
|
A-30
|
|
|
|
|
|
|
ARTICLE VII INDEMNIFICATION
|
|
|
A-31
|
|
|
7.1
|
|
|
Indemnification by the Stockholder
|
|
|
A-31
|
|
|
7.2
|
|
|
Indemnification by the Buyer
|
|
|
A-31
|
|
|
7.3
|
|
|
Indemnification Claims
|
|
|
A-31
|
|
|
7.4
|
|
|
Survival of Representations and
Warranties
|
|
|
A-33
|
|
|
7.5
|
|
|
Limitations
|
|
|
A-34
|
|
|
7.6
|
|
|
Purchase Price Adjustment
|
|
|
A-35
|
|
|
|
|
|
|
ARTICLE VIII OTHER AGREEMENTS
|
|
|
A-35
|
|
|
8.1
|
|
|
Proprietary Information
|
|
|
A-35
|
|
|
8.2
|
|
|
No Solicitation or Hiring of
Former Employees
|
|
|
A-35
|
|
A-ii
|
|
|
|
|
|
|
|
|
|
|
|
|
Page
|
|
|
8.3
|
|
|
Payment of Outstanding Amounts
|
|
|
A-35
|
|
|
8.4
|
|
|
Resale Limitations
|
|
|
A-35
|
|
|
8.5
|
|
|
Standstill Agreement
|
|
|
A-36
|
|
|
8.6
|
|
|
Nomination of Director
|
|
|
A-36
|
|
|
8.7
|
|
|
Further Assurances
|
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A-37
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8.8
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Employee Matters and Transition
Services
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A-37
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8.9
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Insurance
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A-38
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ARTICLE IX TAX MATTERS
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A-38
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9.1
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Preparation and Filing of Tax
Returns; Payment of Taxes
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A-38
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9.2
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Tax Contests; Withholding Taxes;
Clearance Certificates and Other Matters
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A-39
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ARTICLE X REGISTRATION RIGHTS
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A-40
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10.1
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Piggyback Registrations
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A-40
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10.2
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Assignment of Rights
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A-40
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10.3
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Legends
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A-40
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ARTICLE XI TERMINATION
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A-41
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11.1
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Termination of Agreement
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A-41
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11.2
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Effect of Termination
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A-41
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ARTICLE XII DEFINITIONS
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A-41
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ARTICLE XIII MISCELLANEOUS
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A-49
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13.1
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Press Releases and Announcements
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A-49
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13.2
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No Third Party Beneficiaries
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A-49
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13.3
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Entire Agreement; Attachments
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A-49
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13.4
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Successors and Assigns
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A-50
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13.5
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Notices
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A-50
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13.6
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Governing Law
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A-50
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13.7
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Amendments and Waivers
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A-50
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13.8
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Severability
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A-51
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13.9
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Submission to Jurisdiction
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A-51
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13.10
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Specific Performance
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A-51
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13.11
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Section Headings
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A-51
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13.12
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Governing Document
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A-51
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13.13
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Exchange Rates
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A-51
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13.14
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Counterparts and Facsimile
Signature
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A-51
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A-iii
STOCK
PURCHASE AGREEMENT
Agreement (the Agreement) entered into as of
June 4, 2007 between NxStage Medical, Inc., a Delaware
corporation (the Buyer), and David S. Utterberg (the
Stockholder).
Preliminary
Statement
1. The Stockholder owns (a) all of the issued and
outstanding shares of each of Medisystems Services Corporation,
a Nevada corporation (MDS Services), and Medisystems
Corporation, a Washington corporation (MDS),
(b) 90% of the issued and outstanding shares of Medisystems
Europe S.p.A., a company organized under the laws of Italy
(MDS Italy), and (c) 0.273% of the value of the
issued and outstanding equity participation of Medimexico s. de
R.L. de C.V., a company organized under the laws of Mexico
(MDS Mexico).
2. MDS owns 10% of the issued and outstanding shares of MDS
Italy and 99.727% of the value of the issued and outstanding
equity participation of MDS Mexico.
3. The Buyer desires to purchase, and the Stockholder
desires to sell, (a) all of the issued and outstanding
shares of each of MDS Services and MDS, (b) all of the
issued and outstanding shares of MDS Italy held by the
Stockholder, and (c) the issued and outstanding equity
participation of MDS Mexico held by the Stockholder (the shares
and equity participation specified in clauses (a), (b) and
(c) of this sentence, the Shares) for the
consideration set forth below, subject to the terms and
conditions of this Agreement (the Transaction).
4. For federal income tax purposes, it is intended that the
Transaction qualify as a reorganization within the meaning of
Section 368(a)(1)(B) of the Code.
NOW, THEREFORE, in consideration of the representations,
warranties and covenants herein contained, the Parties agree as
follows:
ARTICLE I
PURCHASE AND
SALE OF THE SHARES
1.1 Purchase of the Shares from the
Stockholder. Subject to and upon the terms
and conditions of this Agreement, at the Closing the Stockholder
shall sell, transfer, convey, assign and deliver to the Buyer,
and the Buyer shall purchase, acquire and accept from the
Stockholder, all of the Shares. At the Closing, the Stockholder
shall deliver to the Buyer certificates evidencing the Shares
duly endorsed in blank or with stock powers duly executed by the
Stockholder, or such other documentation as may be required
under relevant local laws to transfer title to Shares to the
Buyer.
1.2 Further Assurances. At
any time and from time to time after the Closing, at the
Buyers request and without further consideration, the
Stockholder shall promptly execute and deliver such instruments
of sale, transfer, conveyance, assignment and confirmation, and
take all such other action as the Buyer may reasonably request,
to transfer, convey and assign to the Buyer, and to confirm the
Buyers title to, all of the Shares, to put the Buyer in
actual possession of the assets, properties and businesses of
the Companies to assist the Buyer in exercising all rights with
respect thereto and to carry out the purpose and intent of this
Agreement.
1.3 Purchase Price. The base
purchase price to be paid by the Buyer to the Stockholder for
the Shares (the Base Purchase Price) shall consist
of the Buyer Shares. If, prior to the Closing, there is any
stock dividend, stock split or other change in the character or
amount of the outstanding Buyer Common Stock, then in such event
any and all new, substituted or additional shares of voting
stock of the Buyer to which the Stockholder would have been
entitled by reason of his ownership of the Buyer Shares had the
Closing occurred prior to such event shall be considered Buyer
Shares for purposes of this Agreement and the consideration to
be received by the Stockholder shall be adjusted accordingly.
The Base Purchase Price shall be payable in the manner described
in Section 1.4. No fraction of a share of Buyer Common
Stock shall be
A-1
issued, and any fractional share thereof shall be rounded to the
nearest whole number. The Base Purchase Price shall be subject
to adjustment after the Closing Date pursuant to the provisions
of Section 1.5.
1.4 Payment of Base Purchase
Price.
(a) At the Closing, the Buyer shall deliver:
(i) to the Stockholder, certificate(s) for the number of
Buyer Shares minus the Escrow Shares; and
(ii) to the Escrow Agent, a certificate representing the
Escrow Shares, to be held pursuant to the terms of the Escrow
Agreement, as a reserve for all or part of any adjustments
pursuant to Section 1.5 and to satisfy all or part of any
claims for indemnity pursuant to Article VII hereof.
1.5 Post-Closing
Adjustments. The Base Purchase Price shall be
subject to adjustment after the Closing Date as follows:
(a) Within 60 days after the Closing Date, the Buyer
shall prepare and deliver to the Stockholder the Draft Closing
Balance Sheet and a certificate based on such Draft Closing
Balance Sheet setting forth Buyers calculation of the
Closing Working Capital (the Working Capital
Certificate). The Buyer shall prepare the Draft Closing
Balance Sheet and Working Capital Certificate in accordance with
GAAP applied on a basis consistent with the application of GAAP
to the preparation of the Financial Statements.
(b) At all reasonable times during the 90 days
immediately following Stockholders receipt of the Draft
Closing Balance Sheet and the Working Capital Certificate,
Stockholder and his representatives shall be permitted to review
the records of the Companies relating to the Draft Closing
Balance Sheet and the Working Capital Certificate, and the Buyer
shall direct any accountants engaged to prepare the Draft
Closing Balance Sheet and the Working Capital Certificate, upon
receipt of customary waivers, to permit Stockholder and his
representatives to review such accountants work papers, if
any, relating to the Draft Closing Balance Sheet and the Working
Capital Certificate, in each case reasonably requested by
Stockholder, and the Buyer shall make reasonably available to
the Stockholder and his representatives the individuals employed
by the Buyer and responsible for the preparation of the Draft
Closing Balance Sheet and the Working Capital Certificate, in
order to respond to the inquiries of the Stockholder relating
thereto. The Stockholder shall deliver to the Buyer, by the
Objection Deadline Date, either a notice indicating that the
Stockholder accepts the Draft Closing Balance Sheet and the
Buyers calculation of the Closing Working Capital
delivered pursuant to Section 1.5(a) or a detailed
statement describing its objections (if any) to the Draft
Closing Balance Sheet
and/or the
calculation of the Closing Working Capital. If the Stockholder
delivers to the Buyer a notice accepting the Draft Closing
Balance Sheet and the Buyers calculation of the Closing
Working Capital, or the Stockholder does not deliver a written
objection to the Draft Closing Balance Sheet or the calculation
of the Closing Working Capital by the Objection Deadline Date,
then, effective as of either the date of delivery of such notice
of acceptance or as of the close of business on the Objection
Deadline Date, the Draft Closing Balance Sheet shall be deemed
to be the Final Closing Balance Sheet and the amount of Closing
Working Capital as shown on the Working Capital Certificate
shall be deemed to be the Final Closing Working Capital. If the
Stockholder timely objects to the Draft Closing Balance Sheet or
the Buyers calculation of the Closing Working Capital,
such objections shall be resolved as follows:
(i) The Buyer and the Stockholder shall first use
reasonable efforts to resolve such objections.
(ii) If the Buyer and the Stockholder do not reach a
resolution of all objections set forth on the Stockholders
statement of objections within 30 days after delivery of
such statement of objections, the Buyer and the Stockholder
shall, within 30 days following the expiration of such
30-day
period, engage the Accountant, pursuant to an engagement
agreement executed by the Buyer, the Stockholder and the
Accountant, to resolve the Unresolved Objections.
(iii) The Buyer and the Stockholder shall jointly submit to
the Accountant, within 10 days after the date of the
engagement of the Accountant (as evidenced by the date of the
engagement agreement), a copy of the Draft Closing Balance Sheet
and the Working Capital Certificate, a copy
A-2
of the statement of objections delivered by the Stockholder to
the Buyer, and a statement setting forth the resolution of any
objections agreed to by the Buyer and the Stockholder. Each of
the Buyer and the Stockholder shall submit to the Accountant
(with a copy delivered to the other Party on the same day),
within 45 days after the date of the engagement of the
Accountant, a memorandum (which may include supporting exhibits)
setting forth their respective positions on the Unresolved
Objections. Each of the Buyer and the Stockholder may (but shall
not be required to) submit to the Accountant (with a copy
delivered to the other Party on the same day), within
75 days after the date of the engagement of the Accountant,
a memorandum responding to the initial memorandum submitted to
the Accountant by the other Party. Unless requested by the
Accountant in writing, neither Party may present any additional
information or arguments to the Accountant, either orally or in
writing.
(iv) Within 100 days after the date of its engagement
hereunder, the Accountant shall determine whether or to what
degree the objections raised by the Stockholder are correct and
shall issue a ruling which shall include (A) a balance
sheet, consisting of the Draft Closing Balance Sheet as adjusted
pursuant to any resolutions to objections agreed upon by the
Buyer and the Stockholder and pursuant to the Accountants
resolution of the Unresolved Objections and (B) a
calculation of the Closing Working Capital based on the balance
sheet described in clause (A) of this sentence. Such
balance sheet shall be deemed to be the Final Closing
Balance Sheet and the amount of Closing Working Capital
calculated based on such balance sheet shall be deemed to be the
Final Closing Working Capital.
(v) The resolution by the Accountant of the Unresolved
Objections shall be conclusive and binding upon the Buyer and
the Stockholder. The Buyer and the Stockholder agree that the
procedure set forth in this Section 1.5(b) for resolving
disputes with respect to the Draft Closing Balance Sheet
and/or the
Working Capital Certificate shall be the sole and exclusive
method for resolving any such disputes; provided that this
provision shall not prohibit either Party from instituting
litigation to enforce the ruling of the Accountant.
(vi) MDS or the Stockholder shall pay the fees and expenses
of the Accountant based upon the difference between the Draft
Closing Balance Sheet and the Final Closing Balance Sheet or
between the Working Capital Certificate and the Closing Working
Capital, as follows: (1) if either of such difference is
less than $50,000, the fees and expenses of the Accountant shall
be solely borne by the Stockholder; and (2) if either of
such difference exceeds $50,000, the fees and expenses of the
Accountant shall be solely borne by MDS.
(c) Immediately upon the expiration of the Objection
Deadline Date, if no objection to the Draft Closing Balance
Sheet or the calculation of the Closing Working Capital is made,
or upon notification by the Stockholder to the Buyer that no
objection to the Draft Closing Balance Sheet or the calculation
of the Closing Working Capital will be made, or immediately upon
final resolution of any dispute in connection with the
determination of the Closing Working Capital pursuant to this
Section 1.5, the Base Purchase Price shall be adjusted as
follows:
(i) If the Final Closing Working Capital is less than the
Target Amount by $250,000 or more, such deficiency shall be
deducted from the Base Purchase Price (at which point such
deduction shall equal the entire amount of the deficiency, and
not just amounts in excess of $250,000).
(ii) If the Final Closing Working Capital is greater than
the Target Amount by $250,000 or more, such excess shall be
added to the Base Purchase Price (at which point such addition
shall equal the entire amount of the excess, and not just
amounts in excess of $250,000).
(d) The amount, if any, to be paid pursuant to
Section 1.5(c)(i) shall be paid by the Stockholder to the
Buyer not later than two business days following the
Determination Date, first by delivery to Buyer of a number of
Escrow Shares determined by dividing the amount of such
deficiency by the Closing Price, to the extent a sufficient
number of Escrow Shares are available, and the balance, if any,
shall then be payable to the Buyer directly by the Stockholder
in shares of Buyer Common Stock (at an assumed
A-3
value per share equal to the Closing Price with any fractional
share rounded to the nearest whole share)
and/or in
cash, by cashiers or certified check or by wire transfer
of immediately available funds to an account designated by the
Buyer.
(e) The amount, if any, to be paid pursuant to
Section 1.5(c)(ii) shall be paid by the Buyer to the
Stockholder not later than two business days following the
Determination Date in shares of Buyer Common Stock (at an
assumed value per share equal to the Closing Price with any
fractional share rounded to the nearest whole share).
1.6 Escrow Account. The
Escrow Shares shall be held by the Escrow Agent under the terms
of the Escrow Agreement for the purpose of securing the
indemnification obligations of the Stockholder pursuant to
Article VII and any adjustments to the Base Purchase Price
pursuant to Section 1.5. The Escrow Shares shall be held as
a trust fund and shall not be subject to any lien, attachment,
trustee process or any other judicial process of any creditor of
any party, and shall be held and disbursed solely for the
purposes and in accordance with the terms of the Escrow
Agreement.
1.7 The Closing. The Closing
shall take place at the offices of WilmerHale, 60 State Street,
Boston, Massachusetts commencing at 9:00 a.m., local time,
on the Closing Date. The transfer of the Shares by the
Stockholder to the Buyer and the payment of the Base Purchase
Price by the Buyer to the Stockholder shall be deemed to occur
at 9:00 a.m., local time, on the Closing Date.
1.8 Stock Transfer
Documents. At or before the Closing, the
Stockholder shall, and shall cause the relevant Companies to,
enter into and deliver separate stock purchase agreements, share
transfer forms, powers of attorney, stock powers, deeds and any
other documents as may be required under relevant local law to
transfer title to the Shares to the Buyer under this Agreement
(Stock Transfer Documents), with only such
modifications as are necessary in order to maintain
substantially the same legal meaning and effect under local law
as provided in this Agreement, including but not limited to the
following:
(a) Italy.
(i) the share certificates of MDS Italy representing the
entire authorized and issued corporate capital of MDS Italy duly
endorsed to the Buyer before a notary;
(b) Mexico.
(i) a short-form equity participation purchase and sale
agreement between the Stockholder and the Buyer;
(ii) the certificate of contribution representing the
Shares of MDS Mexico owned by the Stockholder; and
(iii) evidence of the entry of the Buyer into MDS
Mexicos partners registry as the new owner of the MDS
Mexico Shares.
1.9 Allocation. The Base
Purchase Price shall be allocated among the Shares of each
Company in a manner that will be mutually agreed by the parties,
in good faith, as soon as practicable following the execution of
this Agreement but in no event later than five (5) business
days prior to Closing. In an event that an adjustment to the
Base Purchase Price is made pursuant to Section 1.5 of this
Agreement, the allocation of the Base Purchase Price shall be
amended to allocate such adjustment to the Shares of such
Company to which such adjustment is attributable. The parties
shall report the Tax consequences of the transactions
contemplated by this Agreement in a manner consistent with the
allocation agreed under this Section 1.9.
A-4
ARTICLE II
REPRESENTATIONS
OF THE STOCKHOLDER REGARDING THE SHARES
The Stockholder represents and warrants to the Buyer that the
statements contained in this Article II are true and
correct as of the date of this Agreement and will be true and
correct as of the Closing as though made as of the Closing.
2.1 Title. The Stockholder
has good and marketable title to the Shares which are to be
transferred to the Buyer by the Stockholder pursuant hereto,
free and clear of any and all covenants, conditions,
restrictions, voting trust arrangements, liens, charges,
encumbrances, options and adverse claims or rights whatsoever.
Schedule I sets forth a true and correct description
of all Shares owned by the Stockholder.
2.2 Authority. The
Stockholder has the full capacity, right, power and authority to
enter into this Agreement, to consummate the transactions
contemplated hereby and to transfer, convey and sell to the
Buyer, at the Closing, the Shares. Upon consummation of the
purchase contemplated hereby, the Buyer will acquire from the
Stockholder good and marketable title to the Shares, free and
clear of all covenants, conditions, restrictions, voting trust
arrangements, liens, charges, encumbrances, options and adverse
claims or rights whatsoever. This Agreement has been duly and
validly executed and delivered by the Stockholder and
constitutes a valid and binding obligation of the Stockholder,
enforceable against the Stockholder in accordance with its
terms, subject to the Bankruptcy Exception. Each of the Related
Agreements to be entered into by the Stockholder, upon execution
thereof by the Stockholder, will constitute a valid and binding
obligation of the Stockholder enforceable against the
Stockholder in accordance with its terms, subject to the
Bankruptcy Exception.
2.3 Noncontravention. Subject
to compliance with the applicable requirements of the Hart-Scott
Rodino Act, neither the execution and delivery by the
Stockholder of this Agreement or any of the Related Agreements
to be entered into by the Stockholder, nor the consummation by
the Stockholder of the transactions contemplated hereby or
thereby, will (a) conflict with or violate any provision of
the Certificate of Incorporation, by-laws or other
organizational document of any of the Companies,
(b) require on behalf of any of the Companies any notice to
or filing with, or any permit, authorization, consent or
approval of, any Governmental Entity, (c) except as set
forth in Section 2.3 of the Company Disclosure Schedule,
conflict with, result in a breach of, constitute (with or
without due notice or lapse of time or both) a default under,
result in the acceleration of obligations under, create in any
party the right to terminate, modify or cancel, or require any
notice, consent or waiver under, any contract or instrument to
which any of the Companies is a party or by which any of the
Companies is bound or to which any of their respective assets is
subject, (d) result in the imposition of any Security
Interest upon any assets of any of the Companies or
(e) violate any order, writ, injunction, decree, statute,
rule or regulation applicable to any of the Companies or any of
their respective properties or assets, except in the case of
clauses (c), (d) and (e) of this Section 2.3 for
any such conflicts, violations, breaches, defaults,
terminations, cancellations, accelerations or losses that,
individually or in the aggregate, are not reasonably likely to
have a Company Material Adverse Effect.
2.4 Approvals. The
Stockholder is not a party to, subject to or bound by any
agreement or any judgment, order, writ, prohibition, injunction
or decree of any court or other governmental body which would
prevent the execution or delivery of this Agreement by the
Stockholder or the transfer, conveyance and sale of the Shares
to the Buyer pursuant to the terms hereof.
2.5 Brokers. The Stockholder
has no liability or obligation to pay any fees or commissions to
any broker, finder or agent with respect to the transactions
contemplated by this Agreement.
2.6 Residency. The
Stockholder is not a resident of Italy or Mexico.
A-5
ARTICLE III
REPRESENTATIONS
AND WARRANTIES OF THE STOCKHOLDER REGARDING THE COMPANIES
The Stockholder represents and warrants to the Buyer that,
except as expressly set forth in the Company Disclosure
Schedule, the statements contained in this Article III are
true and correct as of the date of this Agreement and will be
true and correct as of the Closing as though made as of the
Closing, except to the extent such representations and
warranties are specifically made as of a particular date (in
which case such representations and warranties will be true and
correct as of such date). The Company Disclosure Schedule shall
be arranged in sections and subsections corresponding to the
numbered and lettered sections and subsections contained in this
Article III. An item of disclosure in any section or
subsection of the Company Disclosure Schedule shall be deemed to
be a disclosure in any other individual schedule of the Company
Disclosure Schedule as to which the applicability of such item
is readily apparent in light of the disclosure made. For
purposes of this Article III, the phrase to the
knowledge of the Companies or any phrase of similar import
shall be deemed to refer to the actual knowledge of the
Stockholder and each of the following individuals: Gus Azel,
Jorge Celiceo, Melanie Imperial and Luigi Tagliavini (after
reasonable inquiry and investigation).
3.1 Organization, Qualification and Corporate
Power. Each of MDS, MDS Services and MDS
Italy is a corporation duly organized, validly existing and in
corporate and tax good standing, or local equivalent, under the
laws of the jurisdiction of its incorporation. MDS Mexico is a
limited liability company duly organized, validly existing and
in corporate and tax good standing, or local equivalent, under
the laws of Mexico. Each of the Companies is duly qualified to
conduct business and is in corporate and tax good standing, or
local equivalent, under the laws of each jurisdiction listed in
Section 3.1 of the Company Disclosure Schedule, which
jurisdictions constitute the only jurisdictions in which the
nature of the Companies businesses or the ownership or
leasing of their properties requires such qualification, except
for such failures to be so organized, qualified or in good
standing, individually or in the aggregate, that have not had,
and are not reasonably likely to have, a Company Material
Adverse Effect. Each of the Companies has all requisite
corporate power and authority to carry on the businesses in
which it is engaged and to own and use the properties owned and
used by it. Each of the Companies has furnished to the Buyer
complete and accurate copies of its Certificate of Incorporation
and by-laws or other organizational documents, each as amended,
in accordance with applicable local law. None of the Companies
is in default under or in violation of any provision of its
Certificate of Incorporation, by-laws or other organizational
documents.
3.2 Capitalization.
(a) The authorized, issued and paid-in share or equity
participation capital of each of the Companies is as set forth
in Section 3.2(a) of the Company Disclosure Schedule.
(b) Section 3.2(b) of the Company Disclosure Schedule
sets forth a complete and accurate list, as of the date of the
Agreement, of the holders of capital stock or equity
participation in each Company showing the number of shares of
capital stock or equity participation, and the class or series
of such shares or equity participation, held by each stockholder
and (for shares other than common stock) the number of common
shares (if any) into which such shares are convertible.
Section 3.2(b) of the Company Disclosure Schedule also
indicates all outstanding common shares that constitute
restricted stock or that are otherwise subject to a repurchase
or redemption right, indicating the name of the applicable
stockholder, the vesting schedule (including any acceleration
provisions with respect thereto), and the repurchase price
payable by the applicable Company. All of the issued and
outstanding shares or equity participation of capital stock of
each Company have been duly authorized and validly issued and
are fully paid and nonassessable, or local equivalent. All of
the issued and outstanding shares or equity participation of
capital stock of each Company have been offered, issued and sold
by such Company in compliance with all applicable federal and
state securities laws in the relevant jurisdiction.
(c) There are no Company Stock Plans. None of the Companies
has any outstanding Options or Warrants.
A-6
(d) No subscription, warrant, option, convertible security
or other right (contingent or otherwise) to purchase or acquire
any shares or equity participation of capital stock any Company
is authorized or outstanding. No Company has any obligation
(contingent or otherwise) to issue any subscription, warrant,
option, convertible security or other such right, or to issue or
distribute to holders of any shares or equity participation of
its capital stock any evidences of indebtedness or assets of
such Company. No Company has any obligation (contingent or
otherwise) to purchase, redeem or otherwise acquire any shares
or equity participation of its capital stock or any interest
therein or to pay any dividend or to make any other distribution
in respect thereof. There are no outstanding or authorized stock
appreciation, phantom stock or similar rights with respect to
any Company.
(e) There is no agreement, written or oral, between any of
the Companies and any holder of their securities, or, to the
best of the Companies knowledge, among any holders of
their securities, relating to the sale or transfer (including
agreements relating to rights of first refusal, co-sale rights
or drag-along rights), registration under the
Securities Act, or voting, of the capital stock of any of the
Companies.
3.3 Authorization of
Transaction. Each of the Companies has all
requisite power and authority to execute and deliver each of the
Related Agreements to which such Company is a party and to
perform its obligations thereunder. The execution and delivery
by each Company of each of the Related Agreements to be entered
into by such Company and the consummation by each Company of the
transactions contemplated hereby and thereby have been duly and
validly authorized by all necessary corporate action on the part
of each such Company. Each of the Related Agreements to be
entered into by a Company will, upon execution thereof by such
Company, constitute a valid and binding obligation of such
Company, enforceable against such Company in accordance with its
terms, subject to the Bankruptcy Exception.
3.4 [Intentionally Deleted]
3.5 Subsidiaries. Except as
set forth in Section 3.5 of the Company Disclosure
Schedule, none of the Companies has any Subsidiaries nor
controls directly or indirectly or has any direct or indirect
equity participation or similar interest in any corporation,
partnership, limited liability company, joint venture, trust or
other business association or entity.
3.6 Financial
Statements. The Companies have provided to
the Buyer the Financial Statements. The Financial Statements
(i) comply as to form in all respects with applicable
accounting requirements, (ii) were prepared in accordance
with GAAP applied on a consistent basis throughout the periods
covered thereby (except as may be indicated in the notes to such
financial statements) and (iii) fairly present the
consolidated financial position of the Companies as of the dates
thereof and the consolidated results of their operations and
cash flows for the periods indicated, consistent with the books
and records of the Medisystems Operating Companies, except that
the unaudited interim financial statements are subject to normal
and recurring year-end adjustments which will not be material in
amount or effect and do not include footnotes.
3.7 Absence of Certain
Changes. Since the Most Recent Balance Sheet
(a) there has occurred no event or development which,
individually or in the aggregate, has had, or could reasonably
be expected to have in the future, a Company Material Adverse
Effect, and (b) except as set forth in Section 3.7 of
the Company Disclosure Schedule, none of the Companies has taken
any of the actions set forth in paragraphs (a) through
(n) of Section 5.4.
3.8 Undisclosed
Liabilities. None of the Companies has any
liability (whether known or unknown, whether absolute or
contingent, whether liquidated or unliquidated and whether due
or to become due), except for (a) liabilities shown on the
Most Recent Balance Sheet, (b) liabilities which have
arisen since the Most Recent Balance Sheet Date in the Ordinary
Course of Business (including in connection with agreements
entered into in the Ordinary Course of Business) or otherwise in
accordance with the terms and conditions of this Agreement,
(c) liabilities under agreements listed in
Section 3.15(a) of the Company Disclosure Schedule, and
(d) liabilities under agreements which are not required to
be disclosed in the Company Disclosure Schedule and which
liabilities, in the aggregate, are not material.
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3.9 Tax Matters.
(a) Each of the Companies has properly filed on a timely
basis (taking account of extensions) all Tax Returns that it was
required to file, and all such Tax Returns were true, correct
and complete in all material respects. No Company is or has ever
been a member of a group of corporations with which it has filed
(or been required to file) consolidated, combined or unitary Tax
Returns, other than a group of which the common parent is a
Company. Each of the Companies has paid on a timely basis all
Taxes that were due and payable. Except as set forth in
Section 3.9(a) of the Company Disclosure Schedule, the
unpaid Taxes of the Companies for Tax periods through the Most
Recent Balance Sheet Date do not exceed the accruals and
reserves for Taxes (excluding accruals and reserves for deferred
Taxes established to reflect timing differences between book and
Tax income) set forth on the Most Recent Balance Sheet and all
unpaid Taxes of the Companies for all Tax periods commencing
after the date of the Most Recent Balance Sheet Date arose in
the Ordinary Course of Business and are of a type consistent
with, and in an amount commensurate with, Taxes attributable to
prior similar periods (with due regard to intervening changes in
applicable law or administrative practice). None of the
Companies (i) has any actual or potential liability as a
transferee or successor, pursuant to any contractual obligation,
or otherwise for any Taxes of any person other than a Company or
(ii) is a party to or bound by any Tax indemnity, Tax
sharing, Tax allocation or similar agreement. All Taxes that any
of the Companies was required by law to withhold or collect have
been duly withheld or collected and, to the extent required,
have been properly paid to the appropriate Governmental Entity.
(b) The Companies have delivered or made available to the
Buyer (i) complete and correct copies of all Tax Returns of
the Companies relating to Taxes for all taxable periods for
which the applicable statute of limitations has not yet expired
and (ii) complete and correct copies of all private letter
rulings, revenue agent reports to any Company, information
document requests, notices of proposed deficiencies, deficiency
notices, protests, petitions, closing agreements, settlement
agreements, pending ruling requests and any similar documents
submitted by, received by, or agreed to by or on behalf of the
Companies or any of them relating to Taxes for all taxable
periods for which the statute of limitations has not yet
expired. The federal income Tax Returns of the Companies have
been audited by the Internal Revenue Service, or equivalent
Governmental Entity in the relevant
non-U.S. jurisdiction,
or are closed by the applicable statute of limitations for all
taxable years through the taxable year specified in
Section 3.9(b)(i) of the Company Disclosure Schedule.
Except as set forth in Section 3.9(b)(ii) of the Company
Disclosure Schedule, no examination or audit of any Tax Return
of any Company by any Governmental Entity is currently in
progress or, to the knowledge of the Companies, threatened or
contemplated. None of the Companies has been informed by any
jurisdiction that the jurisdiction believes that such Company
was required to file any Tax Return that was not filed. Except
as set forth in Section 3.9(b)(ii) of the Company
Disclosure Schedule, none of the Companies has (x) waived
any statute of limitations with respect to Taxes or agreed to
extend the period for assessment or collection of any Taxes,
(y) requested any extension of time within which to file
any Tax Return, which Tax Return has not yet been filed, or
(z) executed or filed any power of attorney with any taxing
authority.
(c) None of the assets of the Companies (i) is
property that is required to be treated as being owned by any
other person pursuant to the provisions of former Section
168(f)(8) of the Internal Revenue Code of 1954, (ii) is
tax-exempt use property within the meaning of
Section 168(h) of the Code, (iii) directly or
indirectly secures any debt the interest on which is tax exempt
under Section 103(a) of the Code or (iv) is subject to
a lease under Section 7701(h) of the Code or under any
predecessor section.
(d) There are no adjustments under Section 481 of the
Code (or any similar adjustments under any corresponding
foreign, state or local Tax laws) that are required to be taken
into account by the Companies in any period ending after the
Closing Date by reason of a change in method of accounting in
any taxable period ending on or before the Closing Date or as a
result of the consummation of the transactions contemplated by
this Agreement.
(e) None of the Companies (i) is a consenting
corporation within the meaning of former
Section 341(f) of the Code, and none of the assets of the
Companies is subject to an election under former
Section 341(f) of the Code or (ii) has been a United
States real property holding corporation within the meaning of
Section 897(c)(2) of the Code during the applicable period
specified in Section 897(c)(l)(A)(ii) of the Code.
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(f) None of the Companies has ever participated in an
international boycott as defined in Section 999 of the Code.
(g) None of the Companies is a party to a lease that is
treated as a Section 467 rental agreement
within the meaning of Section 467(d) of the Code.
(h) None of the Companies has distributed to its
shareholders or security holders stock or securities of a
controlled corporation, nor has stock or securities of any
Company been distributed, in a transaction to which
Section 355 of the Code applies (i) in the two
(2) years prior to the date of this Agreement or
(ii) in a distribution that could otherwise constitute part
of a plan or series of related
transactions (within the meaning of Section 355(e) of
the Code) that includes the transactions contemplated by this
Agreement.
(i) No Company owns any interest in an entity that is
characterized as a partnership for federal income Tax purposes.
(j) Section 3.9(j) of the Company Disclosure Schedule
sets forth each jurisdiction (other than United States federal)
in which any Company files or filed a Tax Return and each
jurisdiction that has sent notices or communications of any kind
requesting information relating to any Companys nexus with
such jurisdiction.
(k) None of the Companies is or has been a passive foreign
investment company within the meaning of Section 1297 of
the Code.
(l) None of the Companies has incurred (or been allocated)
an overall foreign loss as defined in
Section 904(f)(2) of the Code which has not been previously
recaptured in full as provided in Sections 904(f)(1)
and/or
904(f)(3) of the Code.
(m) None of the Companies is a party to a gain recognition
agreement under Section 367 of the Code.
(n) None of the Companies will be required to include any
item of income in, or exclude any item of deduction from,
taxable income for any period (or any portion thereof) ending
after the Closing Date as a result of any (i) closing
agreement as described in Section 7121 of the Code (or any
corresponding or similar provision of state, local or foreign
Tax law) executed on or prior to the Closing Date,
(ii) installment sale or other open transaction disposition
made on or prior to the Closing Date or (iii) prepaid
amount received on or prior to the Closing Date.
(o) There are no liens or other encumbrances with respect
to Taxes upon any of the assets or properties of the Companies,
other than with respect to Taxes not yet due and payable.
(p) None of the Shares held by the Stockholder that are
shares of common stock of a Company are non-transferable and
subject to a substantial risk of forfeiture within the meaning
of Section 83 of the Code with respect to which a valid
election under Section 83(b) of the Code has not been made.
(q) None of the Companies is or ever has been a party to a
transaction or agreement that is in conflict with the Tax rules
on transfer pricing then in effect in any relevant jurisdiction
and MDS Mexico has complied with all applicable Mexican transfer
pricing rules and other Mexican tax obligations that are
specifically applicable to Mexican corporations doing business
under a maquila program authorization issued by the
Ministry of Economy in Mexico.
(r) None of the Companies has engaged in any
reportable transaction for purposes of Treasury
Regulation
sections 1.6011-4(b)
or Code Section 6111 or any analogous provision of state or
local law.
(s) At all times since its formation, each of MDS Services
and MDS has validly been treated for federal income tax purposes
as an S corporation within the meaning of
Section 1361(a) of the Code and has validly been treated in
a similar manner for purposes of the income tax laws of all
states in which it has been subject to taxation.
(t) None of the Companies has a permanent establishment in
any country (determined under the laws of such country) other
than its country of incorporation or formation.
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3.10 Assets.
(a) Each Company is the true and lawful owner, and has good
title to, all of the material tangible assets owned by such
Company, free and clear of all Security Interests. Except for
the assets described in Section 3.10(a) of the Company
Disclosure Schedule, the Companies own, lease or possess under a
bailment or other agreement all material tangible assets
currently used in all businesses of the Companies, and such
material tangible assets are sufficient for the conduct of the
Companies businesses. Each such material tangible asset is
free from material defects, has been maintained in accordance
with normal industry practice, is in good operating condition
and repair (subject to normal wear and tear) and is suitable for
the purposes for which it presently is used.
(b) Section 3.10(b) of the Company Disclosure Schedule
lists individually (i) all fixed assets (within the meaning
of GAAP) of the Companies having a book value greater than
$5,000, indicating the cost, accumulated book depreciation (if
any) and the net book value of each such fixed asset as of the
Most Recent Balance Sheet Date, and (ii) all other assets
of a tangible nature (other than inventories) of the Companies
whose book value exceeds $5,000.
3.11 Owned Real
Property. None of the Companies owns or has
ever owned any Real Property.
3.12 Real Property
Leases. Section 3.12 of the Company
Disclosure Schedule lists all Leases and lists the term of each
such Lease, any extension and expansion options, and the rent
payable thereunder. The Companies have delivered to the Buyer
complete and accurate copies of the Leases. With respect to each
Lease:
(a) such Lease is legal, valid, binding, enforceable and in
full force and effect;
(b) such Lease will continue to be legal, valid, binding,
enforceable and in full force and effect immediately following
the Closing in accordance with the terms thereof as in effect
immediately prior to the Closing;
(c) neither the applicable Company nor, to the knowledge of
the Companies, any other party, is in breach or violation of, or
default under, any such Lease, and no event has occurred, is
pending or, to the knowledge of the Companies, is threatened,
which, after the giving of notice, with lapse of time, or
otherwise, would constitute a breach or default by the
applicable Company or, to the knowledge of the Companies, any
other party under such Lease;
(d) there are no disputes, oral agreements or forbearance
programs in effect as to such Lease;
(e) the applicable Company has not assigned, transferred,
conveyed, mortgaged, deeded in trust or encumbered any interest
in the leasehold or subleasehold;
(f) to the knowledge of the Companies, all facilities
leased or subleased thereunder are supplied with utilities and
other services adequate for the operation of said facilities and
the businesses of the Companies;
(g) the Companies are not aware of any Security Interest,
easement, covenant or other restriction applicable to the real
property subject to such lease which would reasonably be
expected to materially impair the current uses or the occupancy
by the applicable Company of the property subject thereto;
(h) the Companies are not in discussions with any landlords
or lessors regarding potential changes to rental payments,
duration of term or other material terms of the Leases; and
(i) this Transaction will not trigger any consent
and/or
notice requirements under any of the Leases.
3.13 Intellectual Property
(a) Company
Registrations. Section 3.13(a) of the
Company Disclosure Schedule lists all Registered Company
Intellectual Property, in each case enumerating specifically the
applicable filing or registration number, title, jurisdiction in
which filing was made or from which registration issued and date
of filing or issuance. To the knowledge of the Companies and
except as otherwise indicated in Section 3.13(a) of the
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Company Disclosure Schedule, all registered copyrights and
trademarks included in the Registered Company Intellectual
Property are valid and enforceable and the Companies have not
received any written notice that any issued Patent included
therein is invalid or unenforceable. To the knowledge of the
Companies and except as otherwise indicated in
Section 3.13(a) of the Company Disclosure Schedule, all
issuance, renewal, maintenance and other payments that are or
have become due with respect to the Registered Company
Intellectual Property have been timely paid.
(b) Prosecution Matters. None of the
Companies nor DSU has received any written notice of, and, to
the knowledge of the Companies, there are no inventorship
challenges, opposition or nullity proceedings, reexaminations,
reissues or interferences that have been declared or instituted
by the patent or trademark office of any jurisdiction, and none
of the Companies or DSU has received any written notice
threatening any such action, in each case, with respect to any
Patent included in the Registered Company Intellectual Property.
The Companies and DSU have complied with their duty of candor
and good faith to the United States Patent and Trademark Office
and any relevant foreign patent office with respect to all
patent and trademark applications included in the Registered
Company Intellectual Property and have not intentionally made
any material misrepresentation in such applications.
(c) Ownership and Right to Use. Each item
of Company Intellectual Property will be available for use by
the Buyer and the Companies immediately following the Closing on
substantially identical terms and conditions as it was available
for use immediately prior to the Closing. As of the Closing
Date, the Companies will exclusively own or otherwise have the
right to use all Intellectual Property used in connection with
the conduct of the businesses as conducted by the Companies
immediately prior to the Closing Date. The Companies are the
sole and exclusive owner of all Intellectual Property included
within the Company Owned Intellectual Property, free and clear
of any Security Interests. The Company Intellectual Property
that is licensed to or exclusively owned by the Companies as of
the Closing Date, or which the Companies otherwise have the
right to use as of the Closing Date, constitutes all
Intellectual Property (other than the Excluded Intellectual
Property) used by the Companies in connection with the conduct
of the Companies business, in all material respects, in
the manner done so by the Companies immediately prior to the
Closing Date.
(d) Reasonable Protection Measures. The
applicable Company has taken commercially reasonable measures to
maintain the confidentiality of the trade secrets and other
material non-public information owned by the Company, or
received from third parties which the Company is obligated to
treat as confidential. To the knowledge of the Companies, there
has been no: (i) material unauthorized disclosure of any
third party proprietary or confidential information in the
possession, custody or control of any Company, or
(ii) material breach of any Companys security
procedures wherein confidential information has been disclosed
to a third person.
(e) Infringement by Companies. To the
knowledge of the Companies, neither the manufacture, use, sale,
offering for sale or importation of the Products by the
Companies, nor any other activity of the Companies in connection
with the operation of their businesses, infringes, violates, or
constitutes a misappropriation of, any Intellectual Property
rights of any third party. To the knowledge of the Companies,
there are no pending claims (and the Companies and DSU have not
received written notice of any threatened claims) by any person
alleging infringement by the Companies of any third party
Intellectual Property. Section 3.13(e) of the Company
Disclosure Schedule lists, and each Company has provided to the
Buyer copies of, any complaint, claim or written notice, or
written threat of any of the foregoing (including any written
notification that a license under any patent is offered or
available, or is or may be required). The representations set
forth in Section 3.13(a), (e) and (f) which are
made to the Companies
and/or
DSUs knowledge are made only to the actual knowledge of
the Companies
and/or DSU
without any requirement of inquiry into the actions or
intellectual property rights of third parties.
(f) Infringement of Company Rights. To
the knowledge of the Companies and except as otherwise indicated
in Section 3.13(f) of the Company Disclosure Schedule, no
person (including, without limitation, any current or former
employee, contractor or consultant of any Company) is infringing
or misappropriating any of the Company Owned Intellectual
Property or any Company Licensed Intellectual Property which is
exclusively licensed to any Company. Each Company has provided
to the Buyer copies of all written notices
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provided by the Company or DSU to third parties and claims filed
by the Company or DSU against third parties alleging
infringement of the Company Owned Intellectual Property or any
Company Licensed Intellectual Property exclusively licensed to
any Company.
(g) Outbound IP
Agreements. Section 3.13(g) of the Company
Disclosure Schedule identifies each agreement pursuant to which
any Company has assigned, transferred, licensed, or otherwise
granted any right to any person, or covenanted not to assert any
right, with respect to any Registered Company Intellectual
Property.
(h) Inbound IP
Agreements. Section 3.13(h) of the Company
Disclosure Schedule identifies each agreement pursuant to which
any Company has been granted or has otherwise acquired any
rights with respect to any Registered Company Intellectual
Property (excluding commercially available software programs).
(i) Products. Except as set forth in
Schedule 3.13(i) of the Company Disclosure Schedule, the
manufacture, use, sale, offering for sale and importation of the
Products by the Companies as conducted immediately prior to the
Closing Date is not covered by any claims of any Excluded
Intellectual Property and does not constitute the practice
outside of the Field of inventions, methods or processes claimed
or disclosed in the Licensed Class B Patents. In the event
that this Section 3.13(i) is inaccurate, the sole and
exclusive remedy therefor, shall be that (i) such claims of
Excluded Intellectual Property shall automatically be licensed
under the License Agreement as if such claims were included in
the Licensed Class B Patents thereunder and (ii) MDS
shall have the worldwide, perpetual, irrevocable, fully paid up,
sublicensable right and license under such Excluded Intellectual
Property or Licensed Class B Patents to continue to make,
have made, sell, offer for sale and import such Products in the
manner conducted by the Companies immediately prior to the
Closing Date.
(j) Limitations. The representations and
warranties set forth in this Sections 3.13(c) and
(e) above do not extend to any activities, Products or
portion of the business relating to the Excluded Intellectual
Property or to the practice outside of the Field of the
inventions, methods and processes claimed or disclosed in the
Licensed Class B Patents.
(k) [Intentionally Deleted]
(l) Assignment of Patent Rights. Except
as otherwise indicated in Section 3.13(l) of the Company
Disclosure Schedule, each employee of the Companies has executed
a valid and binding written agreement expressly assigning to
such Company, to the extent legally permissible, all right,
title and interest in any inventions, trade secrets and works of
authorship, whether or not patentable, invented, created,
developed, conceived
and/or
reduced to practice during the term and in the course of such
employees employment for such Company, and all
Intellectual Property rights therein.
(m) Government Support and
Funding. Except as set forth in
Section 3.13(m) of the Company Disclosure Schedule, the
Companies have not created or reduced to practice any inventions
claimed in the Patents included within the Company Licensed
Intellectual Property using any federal funding, or facilities
of any university, college, or other educational institution or
research center.
3.14 Inventory. All
inventory of the Companies consists of a quality and quantity
usable and saleable in the Ordinary Course of Business, except
for obsolete items and items of below-standard quality, all of
which, to the extent reflected on the Most Recent Balance Sheet,
have been written-off or written-down to net realizable value.
All such inventories of the Companies that have not been
written-off have been priced at the lower of cost or net
realizable value on a
first-in,
first-out basis. The quantities of each type of inventory of the
Companies, whether raw materials,
work-in-process
or finished goods, are not excessive in the present
circumstances of the Companies.
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3.15 Contracts.
(a) Section 3.15(a) of the Company Disclosure Schedule
lists the following agreements (written or oral) to which any
Company is a party as of the date of this Agreement under which
any of the Companies has any ongoing or surviving obligations or
rights:
(i) any agreement (or group of related agreements) for the
lease of personal property from or to third parties providing
for lease payments in excess of $10,000 per annum or having a
remaining term longer than six months;
(ii) any agreement (or group of related agreements) for the
purchase or sale of products (including yet to be developed
products) or for the furnishing or receipt of services
(A) which calls for performance over a period of more than
six months, (B) which involves more than the sum of
$50,000, or (C) in which any Company has granted
manufacturing rights, most favored nation pricing
provisions or marketing or distribution rights relating to any
products or territory or has agreed to purchase a minimum
quantity of goods or services or has agreed to purchase goods or
services exclusively from a certain party;
(iii) any agreement concerning the establishment or
operation of a partnership, joint venture or limited liability
company;
(iv) any agreement (or group of related agreements) under
which it has created, incurred, assumed or guaranteed (or may
create, incur, assume or guarantee) indebtedness (including
capitalized lease obligations) or under which it has imposed (or
may impose) a Security Interest on any of its assets, tangible
or intangible, and the amount of indebtedness outstanding as of
the date of this Agreement under each such agreement;
(v) any agreement for the disposition of any significant
portion of the assets or business of any Company (other than
sales of products in the Ordinary Course of Business) or any
agreement for the acquisition of the assets or business of any
other entity (other than purchases of inventory or components in
the Ordinary Course of Business);
(vi) any agreement concerning confidentiality;
(vii) any employment or consulting agreement;
(viii) any agreement involving any current or former
officer, director or stockholder of any Company or an Affiliate
of any Company (other than any agreements with former officers
or former employees in the standard form of the Medisystems
Employment Agreement or the MDS Mexico Employment Agreement,
copies of which are included in Section 3.15(a) of the
Company Disclosure Schedule);
(ix) any agreement under which the consequences of a
default or termination would reasonably be expected to have a
Company Material Adverse Effect;
(x) any agreement which contains any provisions requiring
any Company to indemnify any other party;
(xi) any agreement that could reasonably be expected to
have the effect of prohibiting or impairing the conduct of the
businesses of any Company or the Buyer or any of its
subsidiaries as currently conducted and as currently proposed to
be conducted by the Stockholder;
(xii) any agreement under which any Company is restricted
from selling, licensing or otherwise distributing any of its
technology or products, or providing services to, customers or
potential customers or any class of customers, in any geographic
area, during any period of time or any segment of the market or
line of business;
(xiii) any agreement which would entitle any third party to
receive a license or any other right to intellectual property of
the Buyer or any of the Buyers Affiliates (other than any
Company) following the Closing;
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(xiv) any business associate agreements, under HIPAA;
(xv) any maquila, bailment or other inter-company
agreements; and
(xvi) any other agreement (or group of related agreements)
either involving more than $50,000 or not entered into in the
Ordinary Course of Business.
(b) The Companies have delivered to the Buyer a complete
and accurate copy of each agreement listed in Section 3.13
or Section 3.15(a) of the Company Disclosure Schedule. With
respect to each agreement so listed: (i) the agreement is
legal, valid, binding and enforceable and in full force and
effect, subject to the Bankruptcy Exception; (ii) the
agreement will continue to be legal, valid, binding and
enforceable and in full force and effect immediately following
the Closing in accordance with the terms thereof as in effect
immediately prior to the Closing, subject to the Bankruptcy
Exception; and (iii) none of the Companies nor, to the
knowledge of the Companies, any other party, is in breach or
violation of, or default under, any such agreement, and no event
has occurred, is pending or, to the knowledge of the Companies,
is threatened, which, after the giving of notice, with lapse of
time, or otherwise, would constitute a breach or default by any
Company or, to the knowledge of the Companies, any other party
under such agreement.
3.16 Accounts
Receivable. All accounts receivable of the
Companies reflected on the Most Recent Balance Sheet (other than
those paid since such date) are valid receivables subject to no
setoffs or counterclaims and are current and collectible, net of
the applicable reserve for bad debts on the Most Recent Balance
Sheet. A complete and accurate list of the accounts receivable
reflected on the Most Recent Balance Sheet, showing the aging
thereof, is included in Section 3.16 of the Company
Disclosure Schedule. All accounts receivable of the Companies
that have arisen since the Most Recent Balance Sheet Date are
valid receivables subject to no setoffs or counterclaims and are
collectible, net of a reserve for bad debts in an amount
proportionate to the reserve shown on the Most Recent Balance
Sheet. None of the Companies has received any written notice
from an account debtor stating that any account receivable in an
amount in excess of $10,000 is subject to any contest, claim or
setoff by such account debtor.
3.17 Powers of
Attorney. There are no outstanding powers of
attorney executed on behalf of any Company or the Stockholder
relating to any Company other than those listed in
Section 3.17 of the Company Disclosure Schedule.
3.18 Insurance. Section 3.18
of the Company Disclosure Schedule lists each insurance policy
(including fire, theft, casualty, comprehensive general
liability, workers compensation, business interruption,
environmental, product liability and automobile insurance
policies and bond and surety arrangements) to which any Company
is a party, all of which are in full force and effect. All
applications for insurance of the Companies were truthful,
accurate and complete as of the date of each such application.
Such insurance policies are of the type and in amounts
customarily carried by organizations conducting businesses or
owning assets similar to those of the Companies. There is no
material claim pending under any such policy as to which
coverage has been questioned, denied or disputed by the
underwriter of such policy. All premiums due and payable under
all such policies have been paid, none of the Companies may be
liable for retroactive premiums or similar payments, and the
Companies are otherwise in compliance in all material respects
with the terms of such policies. The Companies have no knowledge
of any threatened termination of, or premium increase with
respect to, any such policy, other than any termination due to a
change of control provision in any such policy. Subject to
Section 8.9 herein, each such policy will continue to be
enforceable and in full force and effect immediately following
the Closing in accordance with the terms thereof as in effect
immediately prior to the Closing. Section 3.18 of the
Company Disclosure Schedule lists all customs bonds currently in
effect for each Company in the amount as determined by the
U.S. Customs and Border Protection Agency (CBP)
to be necessary and proper for the purpose of making customs
entries by the relevant Company.
3.19 Litigation. There is no
Legal Proceeding which is pending or has been threatened in
writing against any Company which (a) seeks either damages
in excess of $25,000 or equitable relief or (b) in any
manner challenges or seeks to prevent, enjoin, alter or delay
the transactions contemplated by this Agreement. There are no
judgments, orders or decrees outstanding against any Company.
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3.20 Warranties. No
agreement of the Companies provides that any product or service
manufactured, sold, leased, licensed or delivered by any Company
is subject to any guaranty, warranty, right of return, right of
credit or other indemnity other than (i) the applicable
terms and conditions of sale or lease of the applicable Company,
which are set forth in the agreements described in
Section 3.15(a) of the Company Disclosure Schedule,
(ii) the applicable labeling, including Instructions
for Use of the Products of the applicable Company, which
have heretofore been provided to the Buyer and
(iii) manufacturers warranties for which none of the
Companies has any liability.
3.21 Employees.
(a) Section 3.21(a) of the Company Disclosure Schedule
contains a list of all employees of each Company employed as of
May 14, 2007 whose annual rate of compensation exceeds
$50,000 per year, along with the position, date of hire, and the
base annual rate of compensation of each such person. Except as
set forth in Section 3.21(a) of the Company Disclosure
Schedule, each current employee of MDS and MDS Services and each
former employee of MDS and MDS Services within the last three
(3) years has entered into a Medisystems Employment
Agreement with the applicable Company, a copy or form of which
has previously been made available to the Buyer. Except as set
forth in Section 3.21(a) of the Company Disclosure
Schedule, each current employee of MDS Mexico whose annual base
rate of compensation exceeds $50,000 per year has entered into
an MDS Mexico Employment Agreement, a copy or form of which has
previously been made available to the Buyer. Each of the current
employees of MDS Italy has entered into an MDS Italy Employment
Agreement, a copy or form of which has previously been made
available to the Buyer. Section 3.21(a) of the Company
Disclosure Schedule contains a list of all employees of each
Company who are a party to a non-competition agreement with such
Company; copies of such agreements have previously been made
available to the Buyer. All of the agreements referenced above
in this Section 3.21(a) will continue to be legal, valid,
binding and enforceable and in full force and effect immediately
following the Closing in accordance with the terms thereof as in
effect immediately prior to the Closing. To the knowledge of the
Companies, as of the date of this Agreement, none of the
employees who are party to such non-competition agreements have
engaged in any activities prohibited by such agreements.
Section 3.21(a) of the Company Disclosure Schedule contains
a list of all employees of each Company as of May 14, 2007
whose home office or employment location is in the United States
who are not citizens of the United States. To the knowledge of
the Companies, no key employee or group of employees has any
plans to terminate employment with any Company. The Companies
have been and are in compliance with all applicable laws and
with all applicable provisions of collective and individual
agreements relating to the hiring and employment of all current
and past employees relating to all aspects of employment,
including, but not limited to, their search, hiring, employment
relationship, and termination.
(b) MDS Italy has been, and is currently in, compliance
with all applicable laws and with all applicable provisions of
collective and individual agreements related to activities that
are performed for MDS Italy by individuals who are not employees
of MDS Italy, including, but not limited to, the past or current
performance by or in favor of MDS Italy, of contratti
dappalto under article 1655 of the Italian
Civil Code and article 29 of Italian Legislative Decree No
276 of September 10, 2003, all past and current performance
of activities under contratti di somministrazione di
manodopera (lending of workmanship), all past and
current performance of activities by lavoratori a
progetto (workers by project) and generally all types
of non-employed providers of services. As of Closing, there are
no pending claims, or grounds for the initiation of claims,
against MDS Italy under article 29 of Italian Legislative
Decree No 276 of September 10, 2003, related to any
contratto dappalto.
(c) Except as set forth in Section 3.21(c) of the
Company Disclosure Schedule, none of the Companies is party to
or bound by any labor or collective bargaining agreement, nor
has any of them experienced, within the last two (2) years,
any strikes, work stoppages, work slowdowns or lockouts,
grievances, complaints, claims of unfair labor practices or
other collective bargaining disputes, and with respect to MDS
Italy, any anti-union behavior (comportamento
antisindacale). The Companies have no knowledge of any
union organization campaigns with regard to any employees of the
Companies and no organizational effort has been made or
threatened, either currently or within the past two years, by or
on behalf of any labor union with respect to any employee or
group of employees of any Company. The Companies have no
obligation either by
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contract or under applicable Laws and Regulations, to inform
and/or
consult with the employees
and/or their
representatives, or to issue any related notices or obtain any
related consents before Closing, regarding the transaction
contemplated by this Agreement.
3.22 Employee Benefits.
(a) Section 3.22(a) of the Company Disclosure Schedule
contains a complete and accurate list of all material Company
Plans other than Company Plans that are government mandated or
disclosed in, or provided pursuant to,
non-U.S. collective
bargaining agreements (made available to the Buyer). Complete
and accurate copies of (i) all Company Plans which have
been reduced to writing, (ii) written summaries of all
unwritten material Company Plans, (iii) all related trust
agreements, insurance contracts and summary plan descriptions,
all as currently in effect, and (iv) all annual reports
filed on IRS Form 5500, 5500C or 5500R and (for all funded
plans) all plan financial statements for the last three plan
years for each Company Plan, have been made available to the
Buyer.
(b) Each Company Plan has been administered in all material
respects in accordance with its terms, and each of the Companies
and the ERISA Affiliates has in all material respects met its
obligations with respect to each Company Plan and has made all
required contributions thereto. Each Company, each ERISA
Affiliate (with respect to each Company Plan) and each Company
Plan is in compliance in all material respects with the
currently applicable provisions of ERISA and the Code and the
regulations thereunder (including Section 4980B of the
Code, Subtitle K, Chapter 100 of the Code and
Sections 601 through 608 and Section 701 et seq. of
ERISA). No Company Plan that is subject to ERISA has assets that
include securities issued by any Company or any ERISA Affiliate.
(c) There are no Legal Proceedings (except claims for
benefits payable in the normal operation of the Company Plans
and proceedings with respect to qualified domestic relations
orders) against or involving any Company Plan or asserting any
rights or claims to benefits under any Company Plan that could
reasonably be expected to give rise to any material liability to
the Companies.
(d) Each Company Plan that is intended to be qualified
under Section 401(a) of the Code has received a
determination letter from the Internal Revenue Service to the
effect that such Company Plan is qualified and the plan and the
trust related thereto are exempt from federal income taxes under
Sections 401(a) and 501(a), respectively, of the Code, no
such determination letter has been revoked and revocation has
not been threatened.
(e) No Company Plan is subject to Section 412 of the
Code or Title IV of ERISA. No liability under Title IV
of ERISA has been incurred by the Company or any ERISA Affiliate
that has not been satisfied in full, and no condition exists
that presents a material risk to the Company or any ERISA
Affiliate of incurring a liability under such Title.
(f) No Company Plan is a multiemployer plan (as
defined in Section 4001(a)(3) of ERISA).
(g) Except as reflected in the Financial Statements, there
are no unfunded obligations of the Companies under any Company
Plan providing benefits after termination of employment to any
employee of the Companies (or to any beneficiary of any such
employee), including but not limited to retiree health coverage
and deferred compensation, but excluding continuation of health
coverage required to be continued under Section 4980B of
the Code or other applicable law and insurance conversion
privileges under state law.
(h) No act or omission has occurred and no condition exists
with respect to any Company Plan that would reasonably be
expected to subject any of the Companies to (i) any
material fine, penalty, tax or liability of any kind imposed
under ERISA or the Code or (ii) any obligations to pay a
material amount pursuant to any contractual indemnification or
contribution obligation protecting any fiduciary, insurer or
service provider with respect to any Company Plan.
(i) No Company Plan is funded by or related to a
voluntary employees beneficiary association
within the meaning of Section 501(c)(9) of the Code.
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(j) Section 3.22(j) of the Company Disclosure Schedule
discloses each: (i) agreement between any Company and any
stockholder, director, executive officer or other key employee
of any Company (A) the benefits of which are contingent, or
the terms of which are altered, upon the occurrence of the
transactions contemplated by this Agreement, (B) providing
any term of employment or compensation guarantee or
(C) providing severance benefits or other benefits after
the termination of employment of such director, executive
officer or key employee and (ii) Company Plan, any of the
benefits of which provided thereunder will be increased, or the
vesting of the benefits of which will be accelerated, by the
occurrence of any of the transactions contemplated by this
Agreement or the value of any of the benefits of which provided
thereunder will be calculated on the basis of any of the
transactions contemplated by this Agreement.
(k) Section 3.22(k) of the Company Disclosure Schedule
sets forth the policy of each Company with respect to accrued
vacation, accrued sick time and earned time off and the amount
of such liabilities as of March 31, 2007. With respect to
all employees of MDS Italy, Section 3.22(k) of the Company
Disclosure Schedule also sets forth details of accrued and
unused annual vacation, public holidays, any other paid leaves,
T.F.R. Trattamento di Fine Rapporto, monthly
wages in addition to the twelve calendar monthly wages,
seniority increases, contributions to Employee Benefit Plans and
all allowances and indemnities to which employees are entitled
to under applicable laws, collective agreements and company
policies or practices.
(l) Each Company Plan that is a nonqualified deferred
compensation plan (as defined in Code
Section 409A(d)(1)) has been operated since January 1,
2005 in good faith compliance with Code Section 409A, to
the extent applicable.
3.23 Environmental Matters.
The representations and warranties set forth in this
Section 3.23 shall be the sole representations and
warranties by the Stockholder with respect to matters arising
under or governed by Environmental Laws or relating to Materials
of Environmental Concern, and no other representations and
warranties shall be deemed to apply to such matters.
(a) Each Company is and, has been in compliance in all
material respects with all applicable Environmental Laws. There
is no pending or, to the knowledge of the Companies, written or
oral threat of civil or criminal litigation, written notice of
violation, formal administrative proceeding, formal
investigation or written information request by any Governmental
Entity, relating to the violation of or liability under any
Environmental Law involving any Company.
(b) None of the Companies has any liabilities or
obligations arising from the release by the Companies or any
third party of any Materials of Environmental Concern into the
environment.
(c) None of the Companies is a party to or bound by any
court order, administrative order, consent order or other
written agreement (excluding, however, Permits required under
Environmental Laws, which are addressed in Section 3.23(f)
hereof) between any such Company and any Governmental Entity
whose primary purpose is to impose or confirm legal obligations
or liabilities arising under any Environmental Law.
(d) Set forth in Section 3.23(d) of the Company
Disclosure Schedule is a list of all documents (whether in hard
copy or electronic form) whose primary purpose is to provide
information on the presence of Materials of Environmental
Concern in the soil
and/or
groundwater at premises currently or previously owned or
operated by a Company (whether conducted by or on behalf of such
Company or a third party, and whether done at the initiative of
such Company or directed by a Governmental Entity or other third
party) which such Company has possession of. A complete and
accurate copy of each such document has been provided to the
Buyer.
(e) There is no material environmental liability of any
solid or hazardous waste transporter or treatment, storage or
disposal facility that has been used by any Company and for
which such Company is legally responsible.
(f) Section 3.23(f) of the Company Disclosure Schedule
sets forth a list of all material Permits required by
Environmental Laws issued to or held by any Company. Such listed
Permits are the only material Permits required by Environmental
Laws that are required for the Companies to conduct their
respective businesses.
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Each such Permit is in full force and effect; the applicable
Company is, and at all times has been, in compliance with the
terms of each such Permit; and, to the knowledge of the
Companies, no suspension or cancellation of such Permit is being
threatened in writing or orally. Each such Permit will continue
in full force and effect immediately following the Closing.
3.24 Legal Compliance.
(a) Each Company is conducting and has conducted its
business and operations in compliance in all material respects
with all applicable U.S. and
non-U.S. regional,
federal, state and local laws, regulations, rules, decrees,
writs and orders (Laws and Regulations), including
without limitation the rules and regulations of the United
States Food and Drug Administration (FDA). None of
the Companies has, within the last three (3) years,
received any notice or communication from any Governmental
Entity alleging noncompliance with any applicable Laws and
Regulations. No civil, criminal or administrative action, suit,
demand, claim, complaint, hearing, investigation, notice, demand
letter, warning letter, inquiry, proceeding or request for
information is pending or to the knowledge of the Companies,
threatened against any Company and none of the Companies
currently has any liability (whether actual or contingent) for
failure to comply with any Laws and Regulations. There is no
act, omission, event, or circumstance of which the Companies
have knowledge that would reasonably be expected to give rise to
any such action, suit, demand, claim, complaint, hearing,
investigation, notice, demand letter, warning letter, inquiry,
proceeding or request for information or any such liability. To
the knowledge of the Companies, there has not been any violation
of any Laws and Regulations by any Company in its product
development efforts, submissions or reports to any Governmental
Entity that could reasonably be expected to require
investigation, corrective action or enforcement action. None of
the Companies has ever been or is now subject to FDAs
Applications Integrity Policy (AIP). To the
Companies knowledge, the Companies have not made any false
statements on, or material omissions from, any applications,
approvals, reports, or other submissions to any Governmental
Entity, or made any false statements on, or material omissions
from, any other records and documentation prepared or maintained
to comply with the requirements of any Governmental Entity.
(b) Except for MDS Italy, the Companies facilities
are registered, as required, and each product manufactured by or
on behalf of any Company for commercial distribution in the
United States that is required to be listed (the
Products) with the FDA under Section 510 of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
§ 301 et seq. (the FD&C Act), and the
applicable rules and regulations thereunder, is so listed. Each
Product in current commercial distribution is either a
Class I or Class II medical device as defined under
21 U.S.C. § 360c(a)(1)(A) and (B), and applicable
rules and regulations thereunder and was first marketed under,
and is covered by, an FDA order of substantial equivalence in
response to a premarket notification submitted in compliance
with 21 U.S.C. § 360(k) and the applicable rules
and regulations thereunder, or is exempt from such premarket
notification in accordance with 21 U.S.C.
§ 360(l) or (m) and applicable rules and
regulations thereunder. Each Company is, and at all times has
been, in compliance with, and each Product in current commercial
distribution is designed, manufactured, prepared, assembled,
packaged, labeled, stored and processed in compliance with the
applicable requirements of the Quality System Regulation set
forth in 21 C.F.R. Part 820. Each Company is, and at
all times has been, in compliance with the written procedures,
record-keeping and FDA reporting requirements for Medical Device
Reporting set forth in 21 C.F.R. Part 803. None of the
Companies is subject to any enforcement proceedings by the FDA
and, to the Companies knowledge, no such proceedings have
been threatened. None of the Companies has introduced in
commercial distribution during the period of three calendar
years immediately preceding the date hereof any Products which
were upon their shipment by any Company adulterated or
misbranded in violation of 21 U.S.C. §331.
(c) None of the Companies has received or possesses any of
the following documents: (i) 510(k) rescission letters,
(ii) notice of FDA regulatory actions against any Company
including notice of adverse findings, regulatory, untitled or
warning letters or mandatory recalls, (iii) documentation
related to voluntary or mandatory recalls of any products of the
Companies, (iv) reports of removals or corrections or
correspondence to and from the FDA concerning such reports and
all related investigations or (v) safety alerts.
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(d) Each Company has provided the Buyer a true and correct
copy of each of the following with respect to the last three
calendar years and year-to-date 2007: (i) a list of all
products marketed by such Company or any predecessor thereto,
and for each such product, the legal basis for distributing the
product in interstate commerce, (ii) all justifications by
such Company or any predecessor thereto for not filing a 510(k)
for a change or modification to a marketed device,
(iii) all substantially equivalent or not substantially
equivalent letters received by such Company or any predecessor
to such Company, (iv) all correspondence, meeting notes or
minutes, or related documents concerning material communications
between the FDA and such Company or any predecessor thereto as
they relate to 510(k) submissions, including requests for
additional information and responses thereto, and compliance
matters (v) all management review reports of such Company,
(vi) all documents in response to actual or proposed FDA
regulatory action(s), including all documents showing corrective
actions undertaken by such Company or any predecessor thereto in
response to FDA regulatory action(s), (vii) all FDA reports
of inspection (Establishment Inspection Reports and
Form FDA 483s) and FDA inspection reports of such Company
evaluating compliance with Good Manufacturing Practices
(GMP) or analogous procedures from other
Governmental Entities, including foreign regulatory authorities,
(viii) all Medical Device Reports (MDRs) filed
by such Company or any predecessor to such Company,
(ix) all MedWatch forms received by such Company or any
predecessor thereto, and (x) all written reports of GMP
audits of such Company or any predecessor thereto and their
suppliers in the Companys possession or control. Each
Company has provided the Buyer a true and correct copy of all
product labeling and advertising currently in use, including
that posted on such Companys website and in such
Companys users manuals.
(e) None of the Companies nor, to the knowledge of the
Companies, any other person (i) who has a direct or
indirect ownership interest (as those terms are defined in
42 C.F.R. Section 1001.1001(a)(2)) in any of the
Companies, or (ii) who has an ownership or control interest
(as defined in 42 C.F.R. Section 420.201) in any of
the Companies, or (iii) who is an officer, director, agent
(as defined in 42 C.F.R. Section 1001.1001(a)(2)) or
managing employee (as defined in 42 C.F.R.
Section 420.201) of any of the Companies, has engaged in
any activities which are prohibited, or are cause for civil
penalties or mandatory or permissive exclusion from Medicare,
Medicaid, or any other State Health Care Program or Federal
Health Care Program (as those terms are defined in
42 C.F.R. Section 1001.2) under 42 U.S.C.
Sections 1320a-7,
1320a-7a,
1320a-7b, or
1395nn, or the Federal False Claim Act, 31. U.S.C.
Section 3729, or the regulations promulgated pursuant to
such statutes.
(f) MDS Mexicos maquila program and activities
are in compliance with all applicable Laws and Regulations in
all material respects, and MDS Mexico has obtained all
extensions required for MDS Mexico to carry out its activities
as historically and currently conducted.
(g) MDS Mexico submitted its Sectoral Promotion Programs
(PROSEC) applications to Mexicos Ministry of Economy. The
Ministry of Economy has approved the PROSEC and a true, correct
and complete copy of the application and approval has been
delivered to the Buyer.
(h) All temporarily imported goods that are used by or
located at MDS Mexicos facility are included in MDS
Mexicos maquila program and have been and remain
legally imported in Mexico, and no goods have remained in Mexico
longer than the relevant authorized period.
3.25 Customers and
Suppliers. Section 3.25 of the Company
Disclosure Schedule sets forth a list of (a) each customer
that accounted for more than 1% of the consolidated revenues of
the Companies during the last full fiscal year or the interim
period through the Most Recent Balance Sheet Date and the amount
of revenues accounted for by such customer during each such
period and (b) each supplier that is the sole supplier of
any significant product or service to any Company. No such
customer or supplier has indicated within the past year that it
will stop, or decrease the rate of, buying products or supplying
products, as applicable, to any Company and the Companies have
no reason to believe that any of the foregoing is likely to
occur as a result of the transactions contemplated by this
Agreement or for any other reason within the next
12 months. No unfilled customer order or commitment
obligating any Company to process, manufacture or deliver
products or perform services will result in a loss to such
Company upon completion of performance. No purchase order or
commitment of any Company is in excess of normal requirements,
nor are prices provided therein in excess of current market
prices for the products or services to be provided thereunder.
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3.26 Permits. Section 3.26
of the Company Disclosure Schedule sets forth a list of all
material Permits issued to or held by any Company. Such listed
Permits are the only material Permits that are required for the
Companies to conduct their respective businesses (in the case of
MDS Italy, as required within the last three (3) years).
Each such Permit is in full force and effect; the applicable
Company is, and with respect to each Company other than MDS
Italy, at all times has been and, with respect to MDS Italy,
within the last three (3) years has been, in compliance
with the terms of each such Permit; and, to the knowledge of the
Companies, no suspension or cancellation of such Permit is
threatened and there is no basis for believing that such Permit
will not be renewable upon expiration. Each such Permit will
continue in full force and effect immediately following the
Closing.
3.27 Certain Business Relationships With
Affiliates. Except for (i) the business
relationships between MDS Mexico and certain of its Affiliates
with respect to MDS Mexicos maquila program and
activities as set forth in Section 3.27 of the Company
Disclosure Schedule, (ii) rights pursuant to the License
Agreement and the Consulting Agreement and (iii) payments
and expenses set forth in Section 3.27 of the Company
Disclosure Schedule, no Affiliate of any Company (other than an
Affiliate that is one of the Companies) (a) owns any
property or right, tangible or intangible, which is used in the
business of any Company and which will survive the Closing,
(b) has any claim or cause of action against any Company,
or (c) owes any money to, or is owed any money by, any
Company, which right or obligation will survive the Closing.
Section 3.27 of the Company Disclosure Schedule describes
any transactions or relationships between any Company, on the
one hand, and any Affiliate of such Company (other than any
Affiliate that is one of the Companies), which occurred or have
existed since the beginning of the time period covered by the
Financial Statements and which would have the effect of either
(i) overstating operating income of the Companies if the
parties had not been Affiliates or (ii) understating
operating expense of the Companies if the parties had not been
Affiliates.
3.28 Brokers
Fees. None of the Companies has any liability
or obligation to pay any fees or commissions to any broker,
finder or agent with respect to the transactions contemplated by
this Agreement.
3.29 Books and Records. The
minute books and other similar records of each Company contain
complete and accurate records of all actions taken at any
meetings of such Companys stockholders, Board of Directors
or any committee thereof, and of all written consents executed
in lieu of the holding of any such meeting. The books and
records of each Company accurately reflect in all material
respects the assets, liabilities, business, financial condition
and results of operations of such Company and have been
maintained in accordance with good business and bookkeeping
practices. Section 3.29 of the Company Disclosure Schedule
contains a list of all bank accounts and safe deposit boxes of
the Companies and the names of persons having signature
authority with respect thereto or access thereto.
3.30 Disclosure. No
representation or warranty by any Company contained in this
Agreement (including the Company Disclosure Schedule) omits to
state any material fact necessary, in light of the circumstances
under which it was made, in order to make the statements herein
or therein not misleading. No statement contained in any other
document, certificate or other instrument delivered by or on
behalf of any Company pursuant to this Agreement, contains any
untrue statement of a material fact or omits to state any
material fact necessary, in light of the circumstances under
which it was made, in order to make the statements herein or
therein not misleading.
3.31 Controls and
Procedures.
(a) Each Company maintains accurate books and records
reflecting its assets and liabilities and maintains proper and
adequate internal control over financial reporting which provide
assurance that (i) transactions are executed with
managements authorization, (ii) transactions are
recorded as necessary to permit preparation of the consolidated
financial statements of the Companies and to maintain
accountability for the consolidated assets of the Companies,
(iii) access to assets of such Company is permitted only in
accordance with managements authorization, (iv) the
reporting of assets of such Company is compared with existing
assets at regular intervals and (v) accounts, notes and
other receivables and inventory were recorded accurately, and
proper and adequate procedures are implemented to effect the
collection thereof on a current and timely basis.
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(b) The Companies have not, since July 30, 2002,
extended or maintained credit, arranged for the extension of
credit, modified or renewed an extension of credit, in the form
of a personal loan or otherwise, to or for any director or
executive officer of any of the Companies. Section 3.31(b)
of the Company Disclosure Schedule identifies any loan or
extension of credit maintained by any Company to which the
second sentence of Section 13(k)(1) of the Exchange Act
would apply.
3.32 [Intentionally
Deleted].
3.33 Government
Contracts. None of the Companies is or has
been party to any contract, subcontract, agreement or commitment
with any Governmental Entity.
3.34 Questionable
Payments. None of the Companies (nor, to the
Companies knowledge, any of their respective officers,
directors, executives, representatives, agents or employees)
(a) has used or is using any corporate funds for any
illegal contributions, gifts, entertainment or other unlawful
expenses relating to political activity, (b) has used or is
using any corporate funds for any direct or indirect unlawful
payments to any foreign or domestic government officials or
employees, (c) has violated or is violating any provision
of the Foreign Corrupt Practices Act of 1977, (d) has
established or maintained, or is maintaining, any unlawful fund
of corporate monies or other properties or (e) has made any
bribe, unlawful rebate, payoff, influence payment, kickback or
other unlawful payment of any nature.
3.35 Personally Identifiable Information and
Privacy. Except as set forth in
Section 3.35 of the Company Disclosure Schedule, none of
the Companies is currently or has ever been a business
associate as such term is defined under HIPAA.
3.36 Customs Matters.
(a) Each of the Companies has filed all necessary documents
with CBP and other customs authorities in each of the countries
in which the Companies have imported merchandise, and none of
the Companies has received any notices from CBP or other customs
authorities with regard to the correctness of any such filings.
(b) None of the Companies is the subject of any ongoing
audits, Focused Assessments, investigations or other reviews by
CBP or other customs authorities in any of the countries in
which any Company operates or imports merchandise.
(c) None of the Companies has made any prior disclosures or
other types of voluntary disclosures relating to its import or
export activities in any country during the last three
(3) years.
(d) Within the last three (3) years, none of the
Companies have been asked to provide, nor have they provided, a
statute of limitations waiver in response to any requests from
customs authorities in any country in which any Company imports
or operates.
(e) All powers of attorney currently in existence that have
been granted by each of the Companies to customs brokers are
listed in Section 3.36(e) of the Company Disclosure
Schedule.
(f) Each Company has the appropriate customs bond or other
necessary security in place in each of the countries in which it
operates in order to import merchandise.
(g) During the last three (3) years, none of the
Companies has received any notice of any kind from CBP, or any
other customs authority in any country in which any Company
imports or operates, that any additional duties are, or may be,
due; that a seizure of merchandise has occurred; that liquidated
damages or penalties of any kind are, or may be, due.
(h) None of the products exported by the Companies is the
subject of any controls in place by any countries from which any
Company exports product. To the extent that any of the
merchandise exported by any of the Companies is subject to
specific export regulations or export controls of any kind, each
of the Companies is in full compliance with all applicable laws
and regulations. Any necessary permits, licenses or similar
governmental approvals for the exportation of its products have
been obtained.
(i) Within the last three (3) years, none of the
Companies has been denied a license, permit or other
authorization to export products from any of the countries in
which it operates.
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(j) To the extent that each of the Companies utilizes free
trade agreements, including the North American Free Trade
Agreement, in its export and import activities, each of the
Companies is in full compliance with, and have issued
and/or
received necessary certificates of origin in order to claim
preferential duty treatment for the importations.
(k) Within the last three (3) years, none of the
Companies has received any rulings of any kind from any customs
authorities in any countries in which it imports or exports
merchandise.
ARTICLE IV
REPRESENTATIONS
AND WARRANTIES OF THE BUYER
The Buyer represents and warrants to the Stockholder that,
except as expressly set forth in the Buyer Disclosure Schedule,
the statements contained in this Article IV are true and
correct as of the date of this Agreement and will be true and
correct as of the Closing as though made as of the Closing,
except to the extent such representations and warranties are
specifically made as of a particular date (in which case such
representations and warranties will be true and correct as of
such date). The Buyer Disclosure Schedule shall be arranged in
sections and subsections corresponding to the numbered and
lettered sections and subsections contained in this
Article IV. Any item of disclosure in any section or
subsection of the Buyer Disclosure Schedule shall be deemed to
be a disclosure in any other individual schedule of the Buyer
Disclosure Schedule as to which the applicability of such item
is readily apparent in light of the disclosure made.
4.1 Organization, Standing and
Power. The Buyer is a corporation duly
organized, validly existing and in good standing under the laws
of the jurisdiction of its incorporation, has all requisite
corporate power and authority to own, lease and operate its
properties and assets and to carry on its business as now being
conducted and as proposed to be conducted, and is duly qualified
to do business and is in good standing as a foreign corporation
in each jurisdiction in which the character of the properties it
owns, operates or leases or the nature of its activities makes
such qualification necessary, except for such failures to be so
organized, qualified or in good standing, individually or in the
aggregate, that have not had, and are not reasonably likely to
have, a Buyer Material Adverse Effect.
4.2 Capitalization.
(a) The authorized capital stock of the Buyer consists of
100,000,000 shares of Buyer Common Stock and
5,000,000 shares of preferred stock, $.001 par value
per share (the Buyer Preferred Stock), which shares
may be issued in one or more series from time to time by the
Buyers Board of Directors. The rights and privileges of
each class of the Buyers capital stock are set forth in
the Buyers Certificate of Incorporation. As of the close
of business on May 30, 2007, 29,925,152 shares of
Buyer Common Stock were issued and outstanding and no shares of
Buyer Preferred Stock were issued and outstanding. No material
change in such capitalization has occurred between May 30,
2007 and the date of this Agreement.
(b) Section 4.2(b) of the Buyer Disclosure Schedule
lists the number of shares of Buyer Common Stock reserved for
future issuance as of May 30, 2007 pursuant to equity plans
of the Buyer (collectively, Buyer Stock Plans), and
the total number of outstanding options to purchase shares of
the Buyer Common Stock (such outstanding options, Buyer
Stock Options) under Buyer Stock Plans as of the close of
business on May 30, 2007.
(c) Section 4.2(c) of the Buyer Disclosure Schedule
shows the number of shares of Buyer Common Stock reserved for
future issuance pursuant to warrants or other outstanding rights
(other than Buyer Stock Options) to purchase shares of Buyer
Common Stock outstanding as of May 30, 2007 (such
outstanding warrants or other rights, the Buyer
Warrants).
(d) All outstanding shares of Buyer Common Stock are, and
all shares of Buyer Common Stock subject to issuance as
specified in Sections 4.2(b) and 4.2(c) or pursuant to
Article I, upon issuance on the terms and conditions
specified in the instruments pursuant to which they are
issuable, will be, duly authorized, validly issued, fully paid
and nonassessable and not subject to or issued in violation of
any purchase option, call option, right of first refusal,
preemptive right, subscription right or any similar right under
any provision of the
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DGCL, the Buyers Certificate of Incorporation or By-laws
or any agreement to which the Buyer is a party or is otherwise
bound.
4.3 Authority; No Conflict; Required Filings
and Consents.
(a) The Buyer has all requisite corporate power and
authority to enter into this Agreement and the Related
Agreements and, subject only to the Buyer Stockholder Approval,
to consummate the transactions contemplated by this Agreement
and the Related Agreements. The execution and delivery of this
Agreement and the Related Agreements and the consummation of the
transactions contemplated by this Agreement and the Related
Agreements by the Buyer have been duly authorized by all
necessary corporate action on the part of the Buyer, subject
only to the required receipt of the Buyer Stockholder Approval.
This Agreement has been duly executed and delivered by the Buyer
and constitutes the valid and binding obligation of the Buyer,
enforceable against the Buyer in accordance with its terms,
subject to the Bankruptcy Exception. Each of the Related
Agreements to be entered into by the Buyer, upon execution
thereof by the Buyer, will constitute the valid and binding
obligation of the Buyer, enforceable against the Buyer in
accordance with its terms, subject to the Bankruptcy Exception.
(b) The execution and delivery of this Agreement and the
Related Agreements by the Buyer do not and will not, and the
consummation by the Buyer of the transactions contemplated by
this Agreement and the Related Agreements shall not,
(i) conflict with, or result in any violation or breach of,
any provision of the Certificate of Incorporation or By-laws of
the Buyer, (ii) conflict with, or result in any violation
or breach of, or constitute (with or without notice or lapse of
time, or both) a default (or give rise to a right of
termination, cancellation or acceleration of any obligation or
loss of any material benefit) under, require a consent or waiver
under, constitute a change in control under, require the payment
of a penalty under or result in the imposition of any Security
Interest on the Buyers assets under, any of the terms,
conditions or provisions of any note, bond, mortgage, indenture,
lease, license, contract or other agreement, instrument or
obligation to which the Buyer is a party or by which the Buyer
or any of its properties or assets may be bound, or
(iii) subject to obtaining the Buyer Stockholder Approval
and compliance with the requirements specified in
clauses (i) through (vi) of Section 4.3(c),
conflict with or violate any permit, concession, franchise,
license, judgment, injunction, order, decree, statute, law,
ordinance, rule or regulation applicable to the Buyer or any of
its properties or assets, except in the case of
clauses (ii) and (iii) of this Section 4.3(b) for
any such conflicts, violations, breaches, defaults,
terminations, cancellations, accelerations or losses that,
individually or in the aggregate, are not reasonably likely to
have a Buyer Material Adverse Effect.
(c) No consent, approval, license, permit, order or
authorization of, or registration, declaration, notice or filing
with, any Governmental Entity is required by or with respect to
the Buyer in connection with the execution and delivery of this
Agreement or any Related Agreement by the Buyer or the
consummation by the Buyer of the transactions contemplated by
this Agreement or any Related Agreement, except for (i) the
pre-merger notification requirements under the HSR Act,
(ii) the filing of the Registration Statement with the SEC
in accordance with the Securities Act, (iii) the filing of
the Proxy Statement/Prospectus with the SEC in accordance with
the Exchange Act, (iv) the filing of such reports,
schedules or materials under Section 13 of or
Rule 14a-12
under the Exchange Act and materials under Rule 165 and
Rule 425 under the Securities Act as may be required in
connection with this Agreement and the transactions contemplated
hereby, (v) such consents, approvals, orders,
authorizations, registrations, declarations and filings as may
be required under applicable state securities laws and such
other consents, licenses, permits, orders, authorizations,
filings, approvals and registrations which, if not obtained or
made, would not be reasonably likely, individually or in the
aggregate, to have a Buyer Material Adverse Effect, and
(vi) the filing with the NASDAQ Global Market of (A) a
Notification Form for Listing of Additional Shares and
(B) a Notification Form for Change in the Number of Shares
Outstanding, with respect to the shares of Buyer Common Stock
issuable pursuant to the terms of this Agreement.
(d) The affirmative vote of the holders of a majority of
the shares of Buyer Common Stock present or represented by proxy
and voting at the Buyer Meeting (the Buyer Stockholder
Approval) is the only vote of the holders of any class or
series of the Buyers capital stock or other securities
necessary for approval of the issuance of the Buyer Shares and
for the consummation by the Buyer of the other transactions
contemplated
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by this Agreement. There are no bonds, debentures, notes or
other indebtedness of the Buyer having the right to vote (or
convertible into, or exchangeable for, securities having the
right to vote) on any matters on which stockholders of the Buyer
may vote.
4.4 Reports and Financial
Statements. The Buyer has previously
furnished or made available to the Stockholder complete and
accurate copies, as amended or supplemented, of the Buyer
Reports. The Buyer Reports constitute all of the documents
required to be filed by the Buyer under Section 13 or
subsections (a) or (c) of Section 14 of the
Exchange Act with the SEC from January 1, 2006 through the
date of this Agreement, except for any current reports on
Form 8-K
relating to events occurring during the Buyers current
fiscal quarter, the failure of which to report would not result
in the Buyers failure to be eligible to register its
shares on a
Form S-3
Registration Statement, provided that any such missed reports
are filed with the SEC prior to the filing of the
Form S-3
Registration Statement or the required disclosure is included in
the Buyers
Form 10-Q
for the current fiscal quarter. The Buyer Reports complied in
all material respects with the requirements of the Exchange Act
and the rules and regulations thereunder when filed. As of their
respective dates, the Buyer Reports did not contain any untrue
statement of a material fact or omit to state a material fact
required to be stated therein or necessary to make the
statements therein, in light of the circumstances under which
they were made, not misleading. The audited financial statements
and unaudited interim financial statements of the Buyer included
in the Buyer Reports (i) complied as to form in all
material respects with applicable accounting requirements and
the published rules and regulations of the SEC with respect
thereto when filed, (ii) were prepared in accordance with
GAAP applied on a consistent basis throughout the periods
covered thereby (except as may be indicated therein or in the
notes thereto, and in the case of quarterly financial
statements, as permitted by
Form 10-Q
under the Exchange Act), and (iii) fairly present the
consolidated financial condition, results of operations and cash
flows of the Buyer as of the respective dates thereof and for
the periods referred to therein.
4.5 Absence of Certain
Changes. Since December 31, 2006, there
has occurred no event or development which, individually or in
the aggregate, has had, or could reasonably be expected to have
in the future, a Buyer Material Adverse Effect.
ARTICLE V
COVENANTS
5.1 Closing Efforts. Each of
the Parties shall use his or its Reasonable Best Efforts to take
all actions and to do all things necessary, proper or advisable
to consummate the transactions contemplated by this Agreement,
including using its Reasonable Best Efforts to ensure that
(i) his or its representations and warranties remain true
and correct in all material respects through the Closing Date
and (ii) the conditions to the obligations of the other
Party to consummate the transactions contemplated hereby are
satisfied.
5.2 Governmental and Third-Party Notices and
Consents.
(a) Each Party shall use its Reasonable Best Efforts to
obtain, at its expense, all waivers, permits, consents,
approvals or other authorizations from Governmental Entities,
and to effect all registrations, filings and notices with or to
Governmental Entities, as may be required for such Party to
consummate the transactions contemplated by this Agreement and
to otherwise comply with all applicable laws and regulations in
connection with the consummation of the transactions
contemplated by this Agreement. Without limiting the generality
of the foregoing, each of the Parties shall promptly file any
Notification and Report Forms and related material that it may
be required to file with the Federal Trade Commission and the
Antitrust Division of the United States Department of Justice
under the
Hart-Scott-Rodino
Act, shall use its Reasonable Best Efforts to obtain an early
termination of the applicable waiting period, and shall make any
further filings or information submissions pursuant thereto that
may be necessary, proper or advisable; provided, however, that
notwithstanding anything to the contrary in this Agreement, the
Buyer shall not be obligated (A) to respond to formal
requests for additional information or documentary material
pursuant to 16 C.F.R. 803.20 under the
Hart-Scott-Rodino
Act except to the extent it elects to do so in its sole
discretion or (B) to sell or dispose of
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or hold separately (through a trust or otherwise) any assets or
businesses of the Buyer or its Affiliates, including the
Companies.
(b) The Stockholder shall use its Reasonable Best Efforts
to obtain, at its expense, all such waivers, consents or
approvals from third parties, and to give all such notices to
third parties, as are required to be listed in the Company
Disclosure Schedule.
5.3 Special Meeting,
S-4
Registration Statement and Proxy
Statement/Prospectus.
(a) The Buyer shall use its Reasonable Best Efforts to
obtain, as promptly as practicable, the approval of the issuance
of shares of Buyer Common Stock pursuant to the terms of this
Agreement by the stockholders of the Buyer at a special meeting
of the stockholders of the Buyer (the Buyer
Meeting), as required by the rules of the NASDAQ Global
Market, in accordance with the applicable requirements of the
DGCL. In connection therewith, the Buyer shall prepare, with the
assistance and cooperation of the Stockholder, the
S-4
Registration Statement and the Proxy Statement/Prospectus. The
Buyer shall file the
S-4
Registration Statement with the SEC and shall, with the
assistance of the Stockholder, promptly respond to any SEC
comments on the
S-4
Registration Statement and shall otherwise use its Reasonable
Best Efforts to have the
S-4
Registration Statement declared effective under the Securities
Act as promptly as practicable. Promptly following such time as
the S-4
Registration Statement is declared effective, the Buyer shall
distribute the Proxy Statement/Prospectus to its stockholders.
(b) The Buyer, acting through its Board of Directors, shall
include in the Proxy Statement/Prospectus the recommendation of
its Board of Directors (the Buyer Board) that the
stockholders of the Buyer vote in favor of the approval of the
issuance of shares of Buyer Common Stock pursuant to the terms
of this Agreement. Notwithstanding the foregoing, the obligation
set forth in the foregoing sentence shall not apply (and the
Buyer Board shall be permitted to modify or withdraw any such
recommendation previously made) if the Buyer Board reasonably
concludes, after consultation with its outside legal counsel,
that the fiduciary duties of the Buyer Board under applicable
law prohibit it from fulfilling the obligations in the foregoing
sentence.
(c) The Buyer shall ensure that the
S-4
Registration Statement does not contain an untrue statement of a
material fact or omit to state a material fact required to be
stated therein or necessary to make the statements therein not
misleading (provided that the Buyer shall not be responsible for
the accuracy or completeness of any information relating to the
Stockholder or any of the Companies or furnished by the
Stockholder or any of the Companies in writing for inclusion in
the S-4
Registration Statement).
(d) The Stockholder shall, and shall cause the Companies
to, ensure that any information relating to any of them or
furnished by any of them to the Buyer in writing for inclusion
in the S-4
Registration Statement does not contain an untrue statement of
material fact or omit to state a material fact required to be
stated therein or necessary to make the statements therein not
misleading.
5.4 Operation of
Business. Except as contemplated by this
Agreement during the period from the date of this Agreement to
the Closing, the Stockholder shall cause each of the Companies
to conduct its operations in the Ordinary Course of Business and
in compliance with all applicable laws and regulations and, to
the extent consistent therewith, use its Reasonable Best Efforts
to preserve intact its current business organization, keep its
physical assets in good working condition, keep available the
services of its current officers and employees and preserve its
relationships with customers, suppliers and others having
business dealings with it to the end that its goodwill and
ongoing business shall not be impaired in any material respect.
Without limiting the generality of the foregoing, except as set
forth on Schedule 5.4 attached hereto, prior to the
Closing, the Stockholder shall cause each of the Companies not
to without the written consent of the Buyer:
(a) issue or sell any stock, or equity participation or
other securities of any Company or any options, warrants or
rights to acquire any such stock, or equity participation or
other securities, or repurchase or redeem any stock, or equity
participation or other securities of any Company;
(b) split, combine or reclassify any shares of or equity
participation in its capital stock; or declare, set aside or pay
any dividend or other distribution (whether in cash, stock or
property or any combination thereof) in respect of its capital
stock;
A-25
(c) create, incur or assume any indebtedness (including
obligations in respect of capital leases); assume, guarantee,
endorse or otherwise become liable or responsible (whether
directly, contingently or otherwise) for the obligations of any
other person or entity; or make any loans, advances or capital
contributions to, or investments in, any other person or entity;
(d) enter into, adopt or amend any Employee Benefit Plan or
any employment or severance agreement or arrangement of the type
described in Section 3.22(j) or (except for normal
increases in the Ordinary Course of Business for employees who
are not Affiliates) increase in any manner the compensation or
fringe benefits of, or materially modify the employment terms
of, its directors, officers or employees, generally or
individually, or pay any bonus or other benefit to its
directors, officers or employees (except for existing payment
obligations listed in Section 3.22 of the Company
Disclosure Schedule) or hire any new officers or (except in the
Ordinary Course of Business) any new employees;
(e) acquire, sell, lease, license or dispose of any assets
or property (including any shares or other equity interests in
or securities of any Subsidiary or any corporation, partnership,
association or other business organization or division thereof),
other than purchases and sales of assets in the Ordinary Course
of Business;
(f) mortgage or pledge any of its property or assets or
subject any such property or assets to any Security Interest;
(g) discharge or satisfy any Security Interest or pay any
obligation or liability other than in the Ordinary Course of
Business;
(h) amend its charter, by-laws or other organizational
documents;
(i) change its accounting methods, principles or practices,
except insofar as may be required by a generally applicable
change in GAAP, or make any new elections, or changes to any
current elections, with respect to Taxes;
(j) enter into, amend, terminate, take or omit to take any
action that would constitute a violation of or default under, or
waive any rights under, any contract or agreement of a nature
required to be listed in Section 3.12, Section 3.13,
Section 3.15(a) or Section 3.21 of the Company
Disclosure Schedule;
(k) make or commit to make any capital expenditure in
excess of $10,000 per item or $50,000 in the aggregate, other
than amounts set forth in the capital budget of the Companies
for 2007, a copy of which is attached to
Schedule 5.4 to this Agreement;
(l) institute or settle any Legal Proceeding;
(m) take any action or fail to take any action permitted by
this Agreement with the knowledge that such action or failure to
take action would result in (i) any of the representations
and warranties of the Stockholder set forth in this Agreement
becoming untrue or (ii) any of the conditions set forth in
Section 6.1 not being satisfied; or
(n) agree in writing or otherwise to take any of the
foregoing actions.
5.5 Access to Information.
(a) The Stockholder shall, and shall cause each of the
Companies to, permit representatives of the Buyer to have full
access (at all reasonable times, and in a manner so as not to
interfere with the normal business operations of the Companies)
to all premises, properties, financial, Tax and accounting
records (including the work papers of the independent
accountants of the Companies), contracts, other records and
documents, and personnel, of or pertaining to any of the
Companies.
(b) Within 20 days after the end of each month ending
prior to the Closing, beginning with June 2007, the Stockholder
shall furnish to the Buyer an unaudited income statement of each
Company for such month and a balance sheet of each Company as of
the end of such month, prepared on a basis consistent with the
Financial Statements. Such financial statements shall present
fairly the financial condition and results of
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operations of the Companies on a consolidated basis as of the
dates thereof and for the periods covered thereby, and shall be
consistent with the books and records of the Companies.
5.6 Notice of Stockholder
Changes. From the date of this Agreement
through the Closing Date, the Stockholder shall promptly advise
the Buyer in writing of (a) any event occurring subsequent
to the date of this Agreement that would render any
representation or warranty of the Stockholder contained in
Article II or III to be untrue or inaccurate such that
the condition set forth in Section 6.1(d) would not be
satisfied; (b) any breach of any covenant or obligation of
the Stockholder under this Agreement such that the condition set
forth in Section 6.1(e) would not be satisfied; and
(c) any Company Material Adverse Effect.
5.7 Exclusivity.
(a) The Stockholder shall not, and shall cause each of the
Companies not to, and shall cause each of the Companies to
require each of its officers, directors, employees,
representatives and agents not to, directly or indirectly,
(i) initiate, solicit, encourage or otherwise facilitate
any inquiry, proposal, offer or discussion with any party (other
than the Buyer) concerning any merger, reorganization,
consolidation, recapitalization, business combination,
liquidation, dissolution, share exchange, sale of stock, sale of
material assets or similar business transaction involving any of
the Companies or any division of any of the Companies,
(ii) furnish any non-public information concerning the
business, properties or assets of any of the Companies or any
division of any of the Companies to any party (other than the
Buyer) or (iii) engage in discussions or negotiations with
any party (other than the Buyer) concerning any such transaction.
(b) The Stockholder shall, and shall cause each of the
Companies to, immediately notify any party with which
discussions or negotiations of the nature described in paragraph
(a) above were pending that the Stockholder or such
Company, as the case may be, is terminating such discussions or
negotiations. If the Stockholder or any of the Companies
receives any inquiry, proposal or offer of the nature described
in paragraph (a) above, the Stockholder shall or shall
cause such Company, as the case may be, to, within one business
day after such receipt, notify the Buyer of such inquiry,
proposal or offer, including the identity of the other party and
the terms of such inquiry, proposal or offer.
5.8 Expenses. Except as set
forth in Article VII, Section 1.5 or Section 11.2
hereof and in the Escrow Agreement, the Buyer shall bear its own
costs and expenses (including legal and accounting fees and
expenses) incurred in connection with this Agreement and the
transactions contemplated hereby, and the Stockholder shall bear
the costs and expenses (including legal and accounting fees and
expenses) of the Stockholder and the Companies incurred in
connection with this Agreement and the transactions contemplated
hereby.
5.9 Listing of Buyer
Shares. The Buyer shall file with the NASDAQ
Global Market (a) a Notification Form for Listing
Additional Shares and (b) a Notification Form for Change in
the Number of Shares Outstanding, with respect to the shares of
Buyer Common Stock issuable pursuant to the terms of this
Agreement.
5.10 S-X Financial
Statements.
(a) Prior to the Closing, the Stockholder shall, and shall
cause the Companies to, (i) provide such information,
assistance and cooperation as the Buyer may reasonably request
in connection with any offering or Buyer filings under the
Exchange Act, including, without limitation, assisting with the
preparation of the Proxy Statement/Prospectus and all other
registration statements filed under the Securities Act and
reports under the Securities Act (the Public
Filings), (ii) cooperate with the Buyer so the Buyer
can obtain information sufficient for the Buyer to comply with
the requirements for the Managements Discussion and
Analysis portion of the Public Filings, (iii) use
commercially reasonable efforts to cause the officers of the
Companies to execute any reasonably necessary officers
certificates or management representation letters to the
Companies accountants to issue unqualified reports with
respect to the financial statements to be included in any Public
Filings, (iv) upon reasonable prior notice, use
commercially reasonable efforts to make senior management and
other representatives of the Companies available to participate
in the preparation of any Public Filings or related materials
and (v) request from the present and former independent
accountants of the Companies that they (A) cooperate with
and assist the Buyer in preparing financial statements with
respect to
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the businesses of the Companies for inclusion by the Buyer in
the Public Filings, including in compliance with the applicable
provisions of
Regulation S-X,
Form 8-K,
Form S-3
and
Form S-4,
(B) participate in drafting sessions related to the
preparation of the Public Filings, (C) make work papers
available to the Buyer and its representatives (subject to Buyer
entering into any agreements reasonably required or requested by
the accountants in connection with the provision of such work
papers), (D) deliver comfort-letters in
customary form in connection with any offering, and
(E) deliver consents to the inclusion of financial
statements required in connection with any Public Filing.
(b) Without limiting the foregoing, the Stockholder shall,
and/or shall
cause the Companies to, deliver to the Buyer historical
financial statements for the businesses of the Companies for
fiscal years 2004, 2005 and 2006 (or the applicable portions
thereof), each of the fiscal quarters ended September 30,
2006 and December 31, 2006, and any other financial
information with respect to the businesses of the Companies
required by Item 9.01 of
Form 8-K
and
Regulation S-X
of the SEC for a business acquisition required to be described
in answer to Item 2.01 of
Form 8-K,
including information required in order for the Buyer to prepare
the pro forma financial information required by Item 9.01
of
Form 8-K.
(c) Not later than forty (40) days after the
completion of each fiscal quarter of the Companies that occurs
during the period from the date of this Agreement through the
Closing Date, the Stockholder shall,
and/or shall
cause the Companies to, deliver to the Buyer quarterly financial
statements for the businesses of the Medisystems Operating
Companies (together with any required notes), which financial
statements shall include a balance sheet, statement of
operations and statement of cash flows prepared in a manner
consistent with the Financial Statements.
5.11 FIRPTA Tax
Certificates. Prior to the Closing, the
Stockholder shall cause each Company to deliver to Buyer a
notice that its Shares are not U.S. real property
interests in accordance with Treasury Regulations under
Sections 897 and 1445 of the Code, together with evidence
reasonably satisfactory to Buyer that such Company has provided
notice to the Internal Revenue Service in accordance with the
provisions of
Section 1.897-2(h)(2)
of the Treasury Regulations. If Buyer does not receive the
notice described above prior to the Closing Date, Buyer shall be
permitted to withhold from the payments to be made pursuant to
this Agreement any required withholding Tax under
Section 1445 of the Code.
5.12 [Intentionally Deleted.]
5.13 Notice of Buyer
Changes. From the date of this Agreement
through the Closing Date, the Buyer shall promptly advise the
Stockholder in writing of (a) any event occurring
subsequent to the date of this Agreement that would render any
representation or warranty of the Buyer contained in
Article IV to be untrue or inaccurate such that the
condition set forth in Section 6.2(e) would not be
satisfied; (b) any breach of any covenant or obligation of
the Buyer under this Agreement such that the condition set forth
in Section 6.2(f) would not be satisfied; and (c) any
Buyer Material Adverse Effect.
5.14 Elimination of Certain
Items. Notwithstanding the provisions of
Section 5.4 of this Agreement, prior to the Closing, the
Stockholder shall, subject to Section 8.3 of this
Agreement, (a) cause the Companies to pay, to the extent
not previously paid (i) all accrued royalties owed by the
Companies as of December 31, 2006 under the Non-Exclusive
License to Inventions Sub-License & Royalty Agreement,
dated as of October 1, 1998, between MDS and DSU (as
successor-in-interest
to MTC), as amended, plus all royalties owed by the Companies as
of the effective date of the License Agreement, and (ii) a
cash dividend equal to $55,000.00 per month for each month from
January 1, 2007 through the Closing Date plus a cash
dividend equal to 35% of the Companies net income for the
period from January 1, 2007 through the Closing Date to
reimburse the Shareholder for his tax liability with regards to
the Companies, less the amount of the royalty payable under the
License Agreement as of its effective date, and (b) cause
all other trade payables and trade receivables between any
Company, on the one hand, and all Affiliates of such Company
(other than an Affiliate that is one of the Companies), on the
other hand, to be cancelled; provided, however,
that the aggregate payments to be made under clause (a) of
this sentence shall in no event exceed the cash on hand of the
Companies as of immediately before the Closing Date; and
provided, further, that any shortfall in the
required payments hereunder resulting from the application of
the limitation contained in the preceding proviso shall be paid
by MDS as promptly as possible after the Closing Date out of its
operating income earned after the Closing Date
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and before any amount is paid by any Company to Buyer or any
Affiliate of Buyer. Prior to any payment pursuant to this
Section 5.14, the Stockholder shall provide notice to the
Buyer of the proposed payment (including the amount and
documentation showing the calculation of the amount in a form
reasonably requested by the Buyer, the name of the payee and the
proposed payment date). The Stockholder shall provide to the
Buyer evidence of all payments made pursuant to this
Section 5.14 promptly upon such payment.
5.15 Releases. Effective
upon the Closing Date, to the maximum extent permitted by
applicable law, Stockholder, on behalf of himself and each of
the Medisystems Operating Companies and DSU, hereby irrevocably
releases, acquits and forever discharges the Companies, and each
of them, and their respective employees, directors, officers,
agents, successors, assigns, heirs, executors and administrators
from any and all claims or liability for infringement of any
Intellectual Property or any unauthorized use or disclosure of
trade secrets of the Medisystems Operating Companies and DSU by
any such parties occurring prior to the Closing Date. Effective
upon the Closing Date, to the maximum extent permitted by
applicable law, each of the Companies, hereby irrevocably
releases, acquits and forever discharges the Medisystems
Operating Companies and DSU and each of their respective
employees, directors, officers, agents, successors, assigns,
heirs, executors and administrators from any and all claims or
liability for infringement of any Intellectual Property or any
unauthorized use or disclosure of trade secrets of any of the
Companies by any such parties occurring prior to the Closing
Date.
ARTICLE VI
CONDITIONS
TO CONSUMMATION OF THE TRANSACTIONS
6.1 Conditions to Obligation of the
Buyer. The obligation of the Buyer to
consummate the transactions contemplated by this Agreement is
subject to the satisfaction (or waiver by the Buyer) of the
following conditions:
(a) all applicable waiting periods (and any extensions
thereof) under the
Hart-Scott-Rodino
Act shall have expired or otherwise been terminated;
(b) the issuance of the Buyer Shares to the Stockholder
pursuant to the terms of this Agreement shall have obtained the
Buyer Stockholder Approval;
(c) the Stockholder shall have obtained at his own expense
(and shall have provided copies thereof to the Buyer) all of the
waivers, permits, consents, approvals or other authorizations,
and effected all of the registrations, filings and notices,
referred to in Section 5.2 which are required on the part
of the Stockholder and any of the Companies;
(d) the representations and warranties of the Stockholder
set forth in Article II, the first sentence of
Section 3.1 and in Section 3.3 and any representations
and warranties of the Stockholder set forth in this Agreement
that are qualified as to materiality shall be true and correct
in all respects, and all other representations and warranties of
the Stockholder set forth in this Agreement shall be true and
correct in all material respects, in each case as of the date of
this Agreement and as of the Closing as though made as of the
Closing, except to the extent such representations and
warranties are specifically made as of a particular date (in
which case such representations and warranties shall be true and
correct as of such date);
(e) the Stockholder shall have performed or complied with
his agreements and covenants required to be performed or
complied with under this Agreement as of or prior to the Closing;
(f) no Legal Proceeding shall be pending or threatened in
writing wherein an unfavorable judgment, order, decree,
stipulation or injunction would (i) prevent consummation of
the transactions contemplated by this Agreement, (ii) cause
the transactions contemplated by this Agreement to be rescinded
following consummation or (iii) have, individually or in
the aggregate, a Company Material Adverse Effect, and no such
judgment, order, decree, stipulation or injunction shall be in
effect;
(g) the Stockholder shall have delivered to the Buyer the
Company Certificate;
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(h) the Buyer shall have received the financial statements,
information and other documents required to be provided under
Section 5.10;
(i) the Stockholder shall have caused each Company to hold
a meeting of its stockholder(s) to approve the resignation of
the outgoing directors and officers of each Company and the
appointment of incoming directors and officers, as specified by
Buyer, effective as of the Closing;
(j) the Buyer shall have received copies of the
resignations, effective as of the Closing, of each director and
officer (in the case of MDS Italy, this will include the Board
of Statutory Auditors), of each of the Companies (other than any
such resignations which the Buyer designates, by written notice
to the Stockholder, as unnecessary), and such other
documentation that may be required under relevant local law or
reasonably requested by Buyer to implement the resignation of
the outgoing directors and officers and the appointment of the
incoming directors and officers as specified by Buyer, including
but not limited to full waivers from the outgoing directors
releasing the Companies from any claims, in accordance with text
to be provided by Buyer;
(k) the Buyer shall have received (i) the Escrow
Agreement, duly executed by the Stockholder and the Escrow
Agent; and (ii) the Consulting Agreement, duly executed by
DSU and the Stockholder;
(l) the Buyer shall have received such other certificates
and instruments (including certificates of good standing of each
of the Companies in their jurisdiction of organization and the
various foreign jurisdictions in which they are qualified,
certified charter documents, certificates as to the incumbency
of officers and the adoption of authorizing resolutions) as it
shall reasonably request in connection with the Closing.
6.2 Conditions to Obligation of the
Stockholder. The obligation of the
Stockholder to consummate the transactions contemplated by this
Agreement is subject to the satisfaction of the following
conditions:
(a) all applicable waiting periods (and any extensions
thereof) under the
Hart-Scott-Rodino
Act shall have expired or otherwise been terminated;
(b) the
S-4
Registration Statement shall have become effective in accordance
with the provisions of the Securities Act, and there shall not
be in effect any stop order suspending the effectiveness of the
S-4
Registration Statement or any proceedings seeking such a stop
order;
(c) the Buyer shall have filed with the NASDAQ Global
Market (a) a Notification Form for Listing of Additional
Shares and (b) a Notification Form for Change in the Number
of Shares Outstanding, with respect to the shares of Buyer
Common Stock issuable pursuant to the terms of this Agreement;
(d) the Buyer shall have effected all of the registrations,
filings and notices referred to in Section 5.2 which are
required on the part of the Buyer;
(e) The representations and warranties of the Buyer set
forth in the first sentence of Section 4.1 and in
Section 4.3 and any representations and warranties of the
Buyer set forth in this Agreement that are qualified as to
materiality shall be true and correct in all respects, and all
other representations and warranties of the Buyer set forth in
this Agreement shall be true and correct in all material
respects, in each case as of the date of this Agreement and as
of the Closing as though made as of the Closing, except to the
extent such representations and warranties are specifically made
as of a particular date (in which case such representations and
warranties shall be true and correct as of such date);
(f) the Buyer shall have performed or complied with its
agreements and covenants required to be performed or complied
with under this Agreement as of or prior to the Closing;
(g) no Legal Proceeding shall be pending or threatened in
writing wherein an unfavorable judgment, order, decree,
stipulation or injunction would (i) prevent consummation of
the transactions contemplated by this Agreement, (ii) cause
the transactions contemplated by this Agreement to be rescinded
following consummation or (iii) have, individually or in
the aggregate, a Buyer Material Adverse Effect, and no such
judgment, order, decree, stipulation or injunction shall be in
effect;
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(h) the Buyer shall have delivered to the Stockholder the
Buyer Certificate;
(i) the Stockholder shall have received (i) the Escrow
Agreement, duly executed by the Buyer and the Escrow Agent; and
(ii) the Consulting Agreement, duly executed by the Buyer
or an Affiliate thereof; and
(j) the Stockholder shall have received such other
certificates and instruments (including certificates of good
standing of the Buyer in its jurisdiction of organization,
certified charter documents, certificates as to the incumbency
of officers and the adoption of authorizing resolutions) as it
shall reasonably request in connection with the Closing.
ARTICLE VII
INDEMNIFICATION
7.1 Indemnification by the
Stockholder. The Stockholder shall indemnify
the Buyer in respect of, and hold it harmless against, any and
all Damages incurred or suffered by the Buyer or any Affiliate
thereof resulting from, relating to or constituting:
(a) any breach, as of the date of this Agreement or as of
the Closing Date, of any representation or warranty of the
Stockholder contained in this Agreement or any other agreement
or instrument executed by the Stockholder or any of the
Companies to the Buyer pursuant to this Agreement;
(b) any failure to perform any covenant or agreement of the
Stockholder contained in this Agreement or any agreement or
instrument furnished by the Stockholder or any of the Companies
to the Buyer pursuant to this Agreement; or
(c) any failure of the Stockholder to have good, valid and
marketable title to the Shares, free and clear of all Security
Interests.
7.2 Indemnification by the
Buyer. The Buyer shall indemnify the
Stockholder in respect of, and hold him harmless against, any
and all Damages incurred or suffered by the Stockholder
resulting from, relating to or constituting:
(a) any breach, as of the date of this Agreement or as of
the Closing Date, of any representation or warranty of the Buyer
contained in this Agreement or any other agreement or instrument
executed by the Buyer to the Stockholder pursuant to this
Agreement; or
(b) any failure to perform any covenant or agreement of the
Buyer contained in this Agreement or any agreement or instrument
furnished by the Buyer to the Stockholder pursuant to this
Agreement.
7.3 Indemnification Claims.
(a) An Indemnified Party shall give written notification to
the Indemnifying Party of the commencement of any Third Party
Action. Such notification shall be given within 20 days
after receipt by the Indemnified Party of notice of such Third
Party Action, and shall describe in reasonable detail (to the
extent known by the Indemnified Party) the facts constituting
the basis for such Third Party Action and the amount of the
claimed Damages; provided, however, that no delay or failure on
the part of the Indemnified Party in so notifying the
Indemnifying Party shall relieve the Indemnifying Party of any
liability or obligation hereunder except to the extent of any
Damages caused by or arising out of such failure. Within
20 days after delivery of such notification, the
Indemnifying Party may, upon written notice thereof to the
Indemnified Party, assume control of the defense of such Third
Party Action with counsel reasonably satisfactory to the
Indemnified Party; provided that (i) the Indemnifying Party
may only assume control of such defense if (A) it
acknowledges in writing to the Indemnified Party that any
damages, fines, costs or other liabilities that may be assessed
against the Indemnified Party in connection with such Third
Party Action constitute Damages for which the Indemnified Party
shall be indemnified pursuant to this Article VII and
(B) the amount claimed as Damages is less than or equal to
the amount of Damages for which the Indemnifying Party is liable
under this Article VII and (ii) the Indemnifying Party
may not assume control of the defense of a Third Party Action
involving
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criminal liability or in which equitable relief (provided, that
this clause shall not apply to equitable relief for the
remediation of contamination of environmental media including
soils, sediments, surface water and groundwater) is sought
against the Indemnified Party. If the Indemnifying Party does
not, or is not permitted under the terms hereof to, so assume
control of the defense of a Third Party Action, the Indemnified
Party shall control such defense. The Non-controlling Party may
participate in such defense at its own expense. The Controlling
Party shall keep the Non-controlling Party advised of the status
of such Third Party Action and the defense thereof and shall
consider in good faith recommendations made by the
Non-controlling Party with respect thereto. The Non-controlling
Party shall furnish the Controlling Party with such information
as it may have with respect to such Third Party Action
(including copies of any summons, complaint or other pleading
which may have been served on such party and any written claim,
demand, invoice, billing or other document evidencing or
asserting the same) and shall otherwise cooperate with and
assist the Controlling Party in the defense of such Third Party
Action. The fees and expenses of counsel to the Indemnified
Party with respect to a Third Party Action shall be considered
Damages for purposes of this Agreement if (i) the
Indemnified Party controls the defense of such Third Party
Action pursuant to the terms of this Section 7.3(a) or
(ii) the Indemnifying Party assumes control of such defense
and the Indemnified Party reasonably concludes that the
Indemnifying Party and the Indemnified Party have conflicting
interests or different defenses available with respect to such
Third Party Action. The Indemnifying Party shall not agree to
any settlement of, or the entry of any judgment arising from,
any Third Party Action without the prior written consent of the
Indemnified Party, which shall not be unreasonably withheld,
conditioned or delayed. The Indemnified Party shall not agree to
any settlement of, or the entry of any judgment arising from,
any such Third Party Action without the prior written consent of
the Indemnifying Party, which shall not be unreasonably
withheld, conditioned or delayed. In the event that the Damages
require remediation of releases of Materials of Environmental
Concern at properties of the Companies, the Indemnifying Party
shall be entitled to remediate such releases pursuant to the
least stringent standards consistent with the land use and the
lease obligations existing at such properties as of the Closing
Date, provided further, than any such remediation shall not
adversely affect on-going commercial operations at the property.
(b) In order to seek indemnification under this
Article VII, an Indemnified Party shall deliver a Claim
Notice to the Indemnifying Party. If the Indemnified Party is
the Buyer and is seeking to enforce such claim pursuant to the
Escrow Agreement, the Indemnifying Party shall also deliver a
copy of the Claim Notice to the Escrow Agent.
(c) Within 20 days after delivery of a Claim Notice,
the Indemnifying Party shall deliver to the Indemnified Party a
Response, in which the Indemnifying Party shall: (i) agree
that the Indemnified Party is entitled to receive all of the
Claimed Amount, (ii) agree that the Indemnified Party is
entitled to receive the Agreed Amount; or (iii) dispute
that the Indemnified Party is entitled to receive any of the
Claimed Amount. In connection with any Response delivered
pursuant to (i) or (ii) in the first sentence of this
paragraph (c), the Indemnifying Party shall pay the Claimed
Amount (in the case of clause (i)) or the Agreed Amount (in the
case of clause (ii)) by delivering to the Indemnified Party such
number of shares of Buyer Common Stock (or, in the case of a
claim against the Stockholder, instructions to the Escrow Agent
to release such number of Escrow Shares) as have an aggregate
Value equal to the Claimed Amount or the Agreed Amount, as the
case may be. In the case of such Response regarding a Claim
Notice against the Stockholder, the Stockholder shall
(A) deliver to the Escrow Agent a written notice executed
by both Parties instructing the Escrow Agent to distribute to
the Buyer the appropriate number of Escrow Shares and
(B) to the extent there are insufficient or no remaining
Escrow Shares, deliver to the Buyer original stock certificates
representing the appropriate number of shares of Buyer Common
Stock, together with duly executed and completed stock powers
and written representations relating to ownership of and title
to such shares as reasonably requested by the Buyer. For
purposes of this Article VII, the Value of any
Escrow Shares or other shares of Buyer Common Stock delivered in
satisfaction of an indemnity claim shall be the average of the
last reported sale prices per share of the Buyer Common Stock on
the NASDAQ Global Market over the five consecutive trading days
ending two trading days before such Escrow Shares are
distributed by the Escrow Agent to the Buyer or such other
shares of Buyer Common Stock are delivered to the Indemnified
Party, as applicable, as provided above (subject to equitable
adjustment in the event of any stock split, stock dividend,
reverse stock split or similar event affecting the Buyer Common
Stock since the beginning of such
five-day
period), multiplied by the number of
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such Escrow Shares or such other shares of Buyer Common Stock
are delivered to the Indemnified Party. In the case of any such
shares of Buyer Common Stock that are delivered to the
Stockholder by the Buyer, such shares of Buyer Common Stock
shall not be registered under the Securities Act and shall bear
the following legend:
The shares represented by this certificate have not been
registered under the Securities Act of 1933, as amended, and may
not be offered, sold or otherwise transferred, pledged or
hypothecated unless and until such shares are registered under
such Act or an opinion of counsel satisfactory to the Company is
obtained to the effect that such registration is not
required.
In addition, and notwithstanding any other terms hereof, in no
event shall Buyer be obligated to issue or deliver to
Stockholder, pursuant to this Article VII or the Consulting
Agreement, an aggregate number of shares of Buyer Common Stock
representing twenty percent (20%) or more of the
then-outstanding shares of Buyer Common Stock without the prior
approval of Buyers stockholders.
(d) During the
30-day
period following the delivery of a Response that reflects a
Dispute, the Indemnifying Party and the Indemnified Party shall
use good faith efforts to resolve the Dispute. If the Dispute is
not resolved within such
30-day
period, such Dispute shall be resolved in a state or federal
court sitting in the State of Delaware, in accordance with
Section 13.9. If the Indemnified Party is the Buyer and is
seeking to enforce the claim that is the subject of the Dispute
pursuant to the Escrow Agreement, the Indemnifying Party and the
Indemnified Party shall deliver to the Escrow Agent, promptly
following the resolution of the Dispute (whether by mutual
agreement, arbitration, judicial decision or otherwise), a
written notice executed by both Parties instructing the Escrow
Agent as to what (if any) portion of the Escrow Shares shall be
distributed to the Buyer
and/or the
Stockholder (which notice shall be consistent with the terms of
the resolution of the Dispute).
(e) Notwithstanding the other provisions of this
Section 7.3, if a customer, distributor, supplier or vendor
of the Companies asserts (other than by means of a lawsuit) that
an Indemnified Party is liable to such customer, distributor,
supplier or vendor for a monetary or other obligation which may
constitute or result in Damages for which such Indemnified Party
may be entitled to indemnification pursuant to this
Article VII, and such Indemnified Party reasonably
determines that it has a valid business reason to fulfill such
obligation, then (i) such Indemnified Party shall be
entitled to satisfy such obligation, without prior notice to or
consent from the Indemnifying Party, (ii) such Indemnified
Party may subsequently make a claim for indemnification in
accordance with the provisions of this Article VII, and
(iii) such Indemnified Party shall be reimbursed, in
accordance with the provisions of this Article VII, for any
such Damages for which it is entitled to indemnification
pursuant to this Article VII (subject to the right of the
Indemnifying Party to dispute both the Indemnified Partys
entitlement to indemnification and the amount for which it is
entitled to indemnification, under the terms of this
Article VII).
7.4 Survival of Representations and
Warranties. All representations and
warranties that are covered by the indemnification agreements in
Section 7.1(a) and Section 7.2(a) shall
(a) survive the Closing and (b) shall expire on the
date 24 months following the Closing Date, except that
(i) the representations and warranties set forth in
Article II and Sections 3.1 (Organization,
Qualification and Corporate Power), 3.2 (Capitalization), 3.3
(Authorization of Transaction), 4.1 (Organization, Standing and
Power), 4.2 (Capitalization) and 4.3 (Authority; No Conflict;
Required Filings and Consents) shall survive the Closing without
limitation; (ii) the representations and warranties set
forth in Sections 3.9 (Tax Matters), 3.22 (Employee
Benefits), and 3.36 (Customs Matters) shall survive until
30 days following expiration of all statutes of limitation
applicable to the matters referred to therein and (iii) the
representations and warranties set forth in Section 3.23
(Environmental Matters) shall expire on the date 36 months
following the Closing Date. If an Indemnified Party delivers to
an Indemnifying Party, before expiration of a representation or
warranty, either a Claim Notice based upon a breach of such
representation or warranty, or an Expected Claim Notice based
upon a breach of such representation or warranty, then the
applicable representation or warranty shall survive until, but
only for purposes of, the resolution of any claims arising from
or related to the matter covered by such notice. If the legal
proceeding or written claim with respect to which an Expected
Claim Notice has been given is definitively withdrawn or
resolved in favor of the Indemnified Party, the Indemnified
Party shall promptly so
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notify the Indemnifying Party; and if the Indemnified Party has
delivered a copy of the Expected Claim Notice to the Escrow
Agent and Escrow Shares have been retained in escrow after the
Termination Date (as defined in the Escrow Agreement) with
respect to such Expected Claim Notice, the Indemnifying Party
and the Indemnified Party shall promptly deliver to the Escrow
Agent a written notice executed by both parties instructing the
Escrow Agent to distribute such retained Escrow Shares to the
Stockholder in accordance with the terms of the Escrow
Agreement. The rights to indemnification set forth in this
Article VII shall not be affected by (i) any
investigation conducted by or on behalf of an Indemnified Party
or any knowledge acquired (or capable of being acquired) by an
Indemnified Party, whether before or after the date of this
Agreement or the Closing Date, with respect to the inaccuracy or
noncompliance with any representation, warranty, covenant or
obligation which is the subject of indemnification hereunder or
(ii) any waiver by an Indemnified Party of any closing
condition relating to the accuracy of representations and
warranties or the performance of or compliance with agreements
and covenants.
7.5 Limitations.
(a) Notwithstanding anything to the contrary herein,
(i) the aggregate liability of the Stockholder for Damages
under Section 7.1(a) shall not exceed (x) 50% of the
Closing Value minus (y) $1,250,000 (such resulting amount,
the Cap Amount) and (ii) the Stockholder shall
not be liable under Section 7.1(a) unless and until the
aggregate Damages for which he would otherwise be liable under
Section 7.1(a) exceed $1,250,000 (the
Deductible) (at which point the Stockholder shall
become liable for the Damages under Section 7.1(a) that are
in excess of the Deductible); provided, that the limitations set
forth in this sentence shall not apply to a claim pursuant to
Section 7.1(a) relating to a breach of the representations
and warranties set forth in Article II or Sections 3.1
(Organization, Qualification and Corporate Power), 3.2
(Capitalization), 3.3 (Authorization of Transaction), 3.9 (Tax
Matters), 3.22 (Employee Benefits) or 3.36 (Customs Matters), or
the first or second sentence of Section 3.10(a) (Assets).
For purposes solely of this Article VII, all
representations and warranties of the Stockholder in
Articles II and III (other than Sections 3.7
(Absence of Certain Changes) and 3.30 (Disclosure)) shall be
construed as if the term material and any reference
to Company Material Adverse Effect (and variations
thereof) were omitted from such representations and warranties.
(b) Notwithstanding anything to the contrary herein,
(i) the aggregate liability of the Buyer for Damages under
Section 7.2(a) shall not exceed the Cap Amount, and
(ii) the Buyer shall not be liable under
Section 7.2(a) unless and until the aggregate Damages for
which it would otherwise be liable under Section 7.2(a)
exceed the Deductible (at which point the Buyer shall become
liable for the Damages under Section 7.2(a) that are in
excess of the Deductible); provided, that the limitations set
forth in this sentence shall not apply to a claim pursuant to
Section 7.2(a) relating to a breach of the representations
and warranties set forth in Sections 4.1 (Organization,
Standing and Power), 4.2 (Capitalization) or 4.3 (Authority; No
Conflict; Required Filings and Consents). For purposes solely of
this Article VII, all representations and warranties of the
Buyer in Article IV shall be construed as if the term
material and any reference to Buyer Material
Adverse Effect (and variations thereof) were omitted from
such representations and warranties.
(c) The Escrow Agreement is intended to secure the
indemnification obligations of the Stockholder under this
Agreement. However, the rights of the Buyer under this
Article VII shall not be limited to the Escrow Shares nor
shall the Escrow Agreement be the exclusive means for the Buyer
to enforce such rights; provided that the Buyer shall not
attempt to collect any Damages directly from the Stockholder
unless there are no remaining Escrow Shares held in escrow
pursuant to the Escrow Agreement.
(d) Except with respect to claims based on fraud or willful
misrepresentation, or claims for willful breach of any covenant
or agreement contained in any of the provisions referenced in
Section 13.10 of this Agreement, after the Closing, the
rights of the Indemnified Parties under this Article VII
and the Escrow Agreement shall be the exclusive remedy of the
Indemnified Parties with respect to claims resulting from or
relating to any misrepresentation, breach of warranty or failure
to perform any covenant or agreement contained in this
Agreement, and the Indemnified Parties agree to release and
relinquish any and all other claims that they may have with
respect to such matters, regardless of whether such claims arise
by statute, in equity or at law.
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(e) The Stockholder shall have no right of contribution
against the Companies with respect to any breach by any of the
Companies of any of its representations, warranties, covenants
or agreements.
7.6 Purchase Price
Adjustment. The Buyer and the Stockholder
agree to treat each indemnification payment pursuant to this
Article VII as an adjustment to the Base Purchase Price for
all Tax purposes and shall take no position contrary thereto
unless required to do so by applicable Laws and Regulations.
ARTICLE VIII
OTHER
AGREEMENTS
8.1 Proprietary Information.
(a) Except as otherwise provided in the Consulting
Agreement, the Stockholder and each of his Affiliates shall hold
in confidence and shall use their best efforts to have all
officers, directors and personnel who continue after the Closing
to be employed by the Stockholder or any Affiliate thereof to
hold in confidence all knowledge and information of a secret or
confidential nature with respect to the business of any Company
prior to Closing and not to disclose, publish or make use of the
same without the prior written consent of the Buyer, except to
the extent that such information shall have become public
knowledge other than by breach of this Agreement by the
Stockholder or any such Affiliate.
(b) If (i) the employment of an officer, director or
other employee of the Stockholder or any Affiliate thereof, to
whom secret or confidential knowledge or information concerning
the business of any Company prior to Closing has been disclosed,
is terminated and (ii) such individual is subject to an
obligation to maintain such knowledge or information in
confidence after such termination, the Stockholder shall, upon
request by the Buyer, take all reasonable steps at his expense
to enforce such confidentiality obligation in the event of an
actual or threatened breach thereof. Any legal counsel retained
by the Stockholder in connection with any such enforcement or
attempted enforcement shall be selected by the Stockholder, but
shall be subject to the approval of the Buyer, which approval
shall not be unreasonably withheld.
(c) The Stockholder agrees that the remedy at law for any
breach of this Section 8.1 would be inadequate and that the
Buyer shall be entitled to injunctive relief in addition to any
other remedy it may have upon breach of any provision of this
Section 8.1.
8.2 No Solicitation or Hiring of Former
Employees. Except as provided by law, for a
period of two (2) years after the Closing Date, neither the
Stockholder nor any Affiliate thereof shall (a) solicit any
person who was an employee of any Company on the date hereof or
the Closing Date to terminate his employment with the Buyer (or
any Company, as the case may be) or to become an employee of the
Stockholder or any Affiliate of the Stockholder, or
(b) hire any person who was an employee of any Company on
the date hereof or the Closing Date; provided, however,
that it shall not be a violation of this Section 8.2 for
the Stockholder or any Affiliate thereof (either directly or
through another entity) to (y) advertise employment
opportunities in newspapers, trade publications or other media
not targeted specifically at any such employees of the Buyer or
any Company or (z) solicit
and/or hire
any employee who has ceased to be employed by the Buyer or any
Company for a period of at least six months.
8.3 Payment of Outstanding
Amounts. To the extent not fully paid at or
prior to the Closing as promptly as practicable but not less
than 60 days following the Closing Date, the Buyer shall
cause the Companies to pay to the Stockholder (or to an
Affiliate of the Stockholder designated by the Stockholder) all
amounts required to be paid pursuant to Section 5.14 hereof
subject to the limitation set forth therein.
8.4 Resale Limitations. From
and after the Closing Date until the second anniversary thereof,
the Stockholder shall not sell or otherwise dispose of the Buyer
Shares in (a) short sales or (b) without the
Buyers prior written consent, which consent shall not be
unreasonably withheld, in trades to a single party exceeding
250,000 Buyer Shares. The provisions of this Section 8.4
shall terminate upon the consummation of a Change in Control of
the Buyer. For purposes of this Article VIII, Change
in Control of the Buyer means any transaction or any event
as a result of which (i) any one or more persons or
entities, acting as a group, acquires or, for the first time,
controls or is able to vote (directly or through nominees or
beneficial
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ownership), after the Closing Date, 50% or more of the capital
stock of the Buyer outstanding at the time ordinarily having
power to vote for directors (Voting Stock) of the
Buyer, provided, however, any acquisition directly from the
Buyer shall not constitute a Change in Control, or (ii) the
consummation of a merger, consolidation, reorganization or
recapitalization involving the Buyer or the disposition of all
or substantially all of the assets of the Buyer (a
Business Combination), unless, immediately following
such Business Combination, each of the following two conditions
is satisfied: (A) all or substantially all of the persons
and entities who beneficially owned the Voting Stock of the
Buyer outstanding immediately prior to such Business Combination
beneficially own, directly or indirectly, 50% or more of the
Voting Stock of the resulting or acquiring corporation
outstanding at the time, in substantially the same proportions
as their ownership of the Buyers Voting Stock outstanding
immediately prior to such Business Combination, and (B) no
person or entity beneficially owns, directly or indirectly, 50%
or more of the outstanding Voting Stock of the resulting or
acquiring corporation.
8.5 Standstill Agreement.
(a) From and after the Closing Date until the second
anniversary thereof, except with the prior consent of the Buyer
Board, the Stockholder shall not, and shall not permit any
entity owned or controlled directly or indirectly by him, to:
(i) directly or indirectly acquire, announce its intention
to acquire, make any proposal to acquire, agree or offer to
acquire ownership of any shares of Buyer Common Stock, or any
other securities convertible into, or any options, warrants or
rights to acquire any shares of Buyer Common Stock or any assets
of Buyer (other than property acquired in the ordinary course of
business) from the Buyer or any other person or entity;
(ii) solicit or propose to solicit
or participate in any solicitation of any,
proxy (as such term is defined in
Regulation 14A under the Exchange Act) from any holder of
shares of Buyer Common Stock, become a participant
in a solicitation in opposition to any matter that
has been recommended by a majority of the members of the Buyer
Board, propose or otherwise solicit stockholders of Buyer for
approval of any stockholder proposal, or otherwise seek to
influence or control the management or policies of Buyer in his
capacity as a stockholder of the Buyer; (iii) nominate for
election as a director of the Buyer, or vote his Buyer Shares
for election as a director of the Buyer, any person who is not
nominated by the then incumbent directors of the Buyer;
(iv) vote his Buyer Shares against any proposal or matter
recommended by a majority of the members of the Buyer Board for
approval by the stockholders of the Buyer; (v) take any
action to form, join in or in any way participate in any
partnership, limited partnership or other Group (as such term is
defined under the Exchange Act) with respect to shares of Buyer
Common Stock; or (vi) assist or announce his intention to
assist any other person or entity in doing any of the foregoing.
(b) The provisions of Section 8.5(a) shall not apply
to any actions, determinations or decisions taken or made by the
Stockholder, in his capacity as a director of the Buyer and
shall terminate upon the consummation of a Change in Control of
the Buyer. Nothing contained in this Section 8.5 shall
restrict or impede the Stockholders ability in carrying
out his duties and obligations as a director of the Buyer.
8.6 Nomination of
Director. In the event the Stockholder ceases
to serve as a director of the Buyer, if the Stockholder
nominates an individual (which may include himself) for election
as a director of the Buyer (the Stockholder Nominee)
at any annual meeting of stockholders of the Buyer, the Buyer
Board shall (a) nominate the Stockholder Nominee for
election to the Buyer Board, and (b) recommend that the
Stockholder Nominee be elected to the Buyer Board and such
recommendation shall be included in any proxy statement of the
Buyer relating to the annual meeting at which the stockholders
of the Buyer will consider and act upon such nomination.
Notwithstanding the foregoing, the Buyer shall have no
obligation under this Section 8.6 unless all of the
following conditions are met: (x) the Stockholder Nominee
(i) is willing to serve as a Director of the Buyer;
(ii) is and has been at all times in compliance with
Buyers Code of Business Conduct and Ethics;
(iii) satisfies the criteria/qualifications for service on
the Buyer Board; and (iv) for any Stockholder Nominee other
than the Stockholder, is independent under the
applicable rules of the NASDAQ Global Market; (y) the
director nomination complies with the applicable provisions of
the Buyers Bylaws, as then in effect; and (z) the
Stockholder is not in breach of any covenant or agreement of the
Stockholder contained in this Agreement or any Related
Agreement. The provisions of this Section 8.6 shall
terminate upon the consummation of a Change in Control of the
Buyer.
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8.7 [Intentionally Deleted]
8.8 Employee Matters and Transition
Services.
(a) Subject to the provisions of Section 8.8(b) below
and without prejudice to Buyers right to operate the
business of the Companies in the Buyers sole discretion
after Closing, the Buyer agrees that all persons who are
employees of the Companies immediately prior to the Closing (the
Company Employees) shall (i) continue as
employees of the Companies following the Closing on terms and
conditions which, in the aggregate, are reasonably comparable to
those in effect for similarly situated employees of the
applicable Buyer Affiliate in the relevant jurisdiction, and
(ii) receive benefits which, in the aggregate, are
reasonably comparable to those in effect for similarly situated
employees of the applicable Buyer Affiliate in the relevant
jurisdiction. To the extent that there is no applicable Buyer
Affiliate in the relevant jurisdiction, the Company Employees
shall (x) continue as employees of the Companies following
the Closing on terms and conditions which, in the aggregate, are
reasonably comparable to those currently in effect for such
Company Employees, and (y) receive benefits which, in the
aggregate, are reasonably comparable to those currently in
effect for such Company Employees. Each Company Employee who
remains in the employment of any Company following the Closing
shall be referred to as a Continuing Employee. To
the extent permitted by the Buyer Benefit Plans or by amendment
of the Buyer Benefit Plans (other than any amendment that would
require the approval of the Buyers stockholders), the
Buyer shall, or shall cause an Affiliate of the Buyer to,
recognize and credit each Continuing Employee for the service
with any of the Companies (and any predecessor employer to the
extent previously credited under the Company Plans) for purposes
of participation and vesting under the Buyer Benefit Plans and
for purposes of benefit level under vacation and severance
plans, but not where giving such credit would result in a
duplication of benefits. The Buyer shall use commercially
reasonable efforts to cause to be provided to the Continuing
Employees credit for any co-payments, deductibles and offsets
(or similar payments) made with respect to Company Plans
providing medical or dental benefits during the plan year
including the Closing Date, for the purposes of satisfying any
applicable deductible, out-of-pocket or similar requirements
under corresponding Buyer Benefit Plans. Any waiting periods,
pre-existing condition exclusions and requirements to show
evidence of good health contained in any Buyer Benefit Plans
providing medical, dental or other welfare benefits shall be
waived with respect to the Continuing Employees and their
dependents. Prior to the Closing Date, the Companies shall
cooperate with the Buyer so as to allow the Buyer or the
applicable Buyer Affiliate to meet with the Continuing Employees
(at such times and locations as reasonably agreed to by the
Companies and the Buyer), to conduct an open enrollment period
to enable the Continuing Employees to make benefit enrollment
elections under the Buyer Benefit Plans.
(b) Prior to the Closing Date, MDS and MDS Services shall
(i) contribute to the Medisystems Corporation 401(k) Profit
Sharing Plan (the Company 401(k) Plan) a profit
sharing contribution for the 2006 plan year in an aggregate
amount not in excess of $165,000, (ii) contribute to the
Company 401(k) Plan a pro-rated profit sharing contribution for
the 2007 plan year in an aggregate amount not in excess of
$165,000, and (iii) take all such actions as may be
necessary to cause the Continuing Employees to become fully
vested, immediately prior to the Closing Date, in their account
balances and accrued benefits under the Company 401(k) Plan.
(c) Prior to the Closing Date, the Stockholder shall take
or cause to be taken all necessary action to cause the Companies
to cease to be participating employers in the Company Plans
listed on Schedule 8.8(c) attached hereto, effective
immediately prior to the Closing Date. It is understood that the
Continuing Employees will continue under the other benefit plans
listed in Section 3.22(a) of the Company Disclosure
Schedule at the expense of MDS until December 31, 2007.
(d) Nothing contained in this Agreement shall be
interpreted to impose any limits on the authority of Buyer, in
its sole discretion, to make any change to the terms or
conditions of, or terminate, the employment of any employees of
any Companies or to terminate or amend any Buyer Benefit Plan.
Section 8.8(a) and 8.8(b) above shall not apply to MDS
Italy employees or MDS Mexico employees to the extent such
Section would conflict with the requirements of a national
collective agreement, individual work contract, applicable law
or the current practices of MDS Italy or MDS Mexico.
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8.9 Insurance.
(a) At the Closing, the Buyer shall cause the Companies to
purchase insurance that will provide for product liability
insurance that will survive the Closing for a period of six
(6) years after the Closing, covering all products of the
Companies manufactured prior to the Closing Date on
substantially the same terms and conditions as in effect
immediately prior to the Closing.
(b) For a period of six (6) years after the Closing,
the Buyer shall cause the Companies to maintain in effect
product liability insurance covering all products of the
Companies manufactured after the Closing Date on a claims-made
basis on substantially the same terms and conditions as in
effect as of December 31, 2006.
(c) Buyer agrees that all rights to indemnification now
existing in favor of the directors, officers or employees of any
of the Companies (including, without limitation, any person who
was or becomes a director, officer or employee prior to the
Closing Date) under the applicable local law or as provided in
each Companies Certificate of Incorporation, by-laws or
other organizational document with respect to matters occurring
on or prior to the Closing shall survive the Closing and shall
continue in full force and effect for a period of not less than
six (6) years after the Closing (or, in the case of claims
or other matters occurring on or prior to the expiration of such
six (6) year period which have not been resolved prior to
the expiration of such six (6) year period, until such
matters are finally resolved) and Buyer shall honor, and shall
cause each of the Companies to honor, all such rights. Prior to
the Closing, the Stockholder shall cause the Companies to
purchase and pay in full a policy of directors and
officers liability insurance and errors and omissions
insurance that will survive the Closing for a period of six
(6) years after the Closing. Buyer shall not cancel the
insurance policy purchased by the Companies pursuant to the
immediately preceding sentence.
ARTICLE IX
TAX MATTERS
9.1 Preparation and Filing of Tax Returns;
Payment of Taxes.
(a) To the extent not previously prepared and filed, the
Stockholder shall prepare and timely file or shall cause to be
prepared and timely filed (i) all Tax Returns for any
Income Taxes of MDS Services and MDS for all taxable periods
that end on or before the Closing Date, and (ii) and cause
to be prepared and timely filed all other Tax Returns of any
other Company required to be filed (taking into account
extensions) prior to the Closing Date. The Stockholder shall
make or cause to be made all payments required with respect to
any such Tax Returns. The Buyer shall cooperate fully with the
Stockholder in connection with the preparation and filing of
such Tax Returns. The Stockholder will promptly provide or make
available to the Buyer copies of all such Tax Returns.
(b) The Buyer shall prepare and timely file or shall cause
to be prepared and timely filed all other Tax Returns for the
Companies. The Buyer shall make all payments required with
respect to any such Tax Returns; provided, however, that the
Stockholder shall promptly reimburse the Buyer to the extent any
payment the Buyer is required to make relates to the operations
of any Company for any period ending (or deemed pursuant to
Section 9.1(d) to end) on or before the Closing.
(c) The Buyer and the Stockholder agree that if any Company
is permitted but not required under applicable foreign, state or
local Tax laws to treat the Closing Date as the last day of a
taxable period, the Buyer and the Stockholder shall treat such
day as the last day of a taxable period.
(d) The portion of any Taxes for a taxable period beginning
before and ending after the Closing allocable to the portion of
such period ending on the Closing Date shall be deemed to equal
(i) in the case of Taxes that (x) are based upon or
related to income or receipts or (y) imposed in connection
with any sale or other transfer or assignment of property, other
than Taxes described in Section 9.1(e), the amount which
would be payable if the taxable year ended with the Closing
Date, and (ii) in the case of other Taxes imposed on a
periodic basis (including property Taxes), the amount of such
Taxes for the entire period multiplied by a fraction the
numerator of which is the number of calendar days in the period
ending with the Closing Date and the denominator of which is the
number of calendar days in the entire period. For purposes of
the
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provisions of this Section 9.1(d), each portion of such
period shall be deemed to be a taxable period (whether or not it
is in fact a taxable period). For purposes of
Section 9.1(d)(i)(x), any exemption, deduction, credit or
other item that is calculated on an annual basis shall be
allocated pro rata per day between the period ending on the
Closing Date and the period beginning the day after the Closing
Date.
(e) The Stockholder shall be responsible for the payment of
any transfer, sales, use, stamp, conveyance, value added,
recording, registration, documentary, filing and other
non-Income Taxes and administrative fees (including, without
limitation, notary fees) arising in connection with the
consummation of the transactions contemplated by this Agreement
whether levied on the Buyer, the Stockholder, any Company, or
any of their respective Affiliates (Transfer Taxes).
The Base Purchase Price shall be exclusive of any Transfer Taxes.
9.2 Tax Contests; Withholding Taxes; Clearance
Certificates and Other Matters.
(a) The Stockholder shall have the right to control, at his
own expense, any Tax audit, initiate any claim for refund,
contest, resolve and defend against any assessment, notice of
deficiency, or other adjustment or proposed adjustment relating
to any and all Taxes for any taxable period or portion thereof
ending on or prior to the Closing Date with respect to any
Company to the extent that the Stockholder may have either
(i) a Tax liability (whether as a shareholder of any
Company or otherwise) by reason of such assessment, deficiency
or adjustment or (ii) an indemnification obligation
hereunder with respect; provided, that, the Buyer
shall have the right to participate in any Tax proceeding
concerning such matters at its own expense directly or through
counsel. The Stockholder shall not agree to any settlement of,
or entry of any judgment arising from, any such Tax proceeding
without the prior written consent of the Buyer, which consent
shall not be unreasonably withheld, conditioned or delayed, if
any such settlement or entry of judgment would be reasonably
expected to increase the Tax liability of the Buyer or of any
Company in any taxable period beginning after or including the
Closing Date. The Buyer and the Stockholder shall cooperate in
the preparation of all Tax Returns and the conduct of all Tax
Audits or other administrative or judicial proceedings relating
to the determination of any Tax for any Tax periods for which
one Party could reasonably require the assistance of the other
Party in obtaining any necessary information. Such cooperation
shall include, but not be limited to, furnishing prior
years Tax Returns or return preparation packages to the
extent related to the Companies or any Subsidiary illustrating
previous reporting practices or containing historical
information relevant to the preparation of such Tax Returns, and
furnishing such other information within such Partys
possession requested by the Party filing such Tax Returns as is
relevant to their preparation. Such cooperation and information
also shall include without limitation provision of powers of
attorney for the purpose of signing Tax Returns and defending
audits and promptly forwarding copies of appropriate notices and
forms or other communications received from or sent to any
Taxing Authority which relate to the Companies or any
Subsidiary, and providing copies of all relevant Tax Returns to
the extent related to the Companies or any Subsidiary, together
with accompanying schedules and related workpapers, documents
relating to rulings or other determinations by any Taxing
Authority and records concerning the ownership and Tax basis of
property, which the requested Party may possess.
(b) The Buyer shall have the right to control any other Tax
audit, initiate any other claim for refund, contest, resolve and
defend against any other assessment, notice of deficiency, or
other adjustment or proposed adjustment relating to any and all
Taxes for any taxable period at its own expense. The Buyer shall
not agree to any settlement of, or entry of any judgment arising
from, any such Tax proceeding without the prior written consent
of the Stockholder, which consent shall not be unreasonably
withheld, conditioned or delayed, if any such settlement or
entry of judgment would be reasonably expected to increase
either (i) the Tax liability of the Stockholder in any
taxable period, or (ii) the liability of the
Stockholder pursuant to its indemnification obligation hereunder.
(c) Notwithstanding any other provision in this Agreement,
the Buyer and each Company shall have the right, on or after the
Closing Date, to deduct and withhold Taxes from any payments to
be made hereunder if such withholding is required by law and to
collect any necessary Tax forms, including
Form W-9
or the appropriate series of
Form W-8,
as applicable, or any similar information, from the Stockholder
and any other recipients of payments hereunder. To the extent
that amounts are so withheld, such withheld amounts shall be
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treated for all purposes of this Agreement as having been
delivered and paid to the Stockholder or other recipient of
payments in respect of which such deduction and withholding was
made.
(d) If, prior to the Closing, the Stockholder shall cause a
Company to deliver to Buyer a clearance certificate or similar
document(s) which may be required or permitted by any Tax
Authority to relieve Buyer of any obligation to withhold Taxes
in connection with the Transactions, Buyer shall not withhold
any such Taxes.
(e) [Intentionally Deleted]
(f) If required by Mexican Tax law, the Stockholder shall
timely pay any capital gains Tax on the transfer of his MDS
Mexico equity participation to the Buyer. The Stockholder shall
deliver a copy of the corresponding Mexican Tax Return and
certified public accountants report (dictamen), if
any (or documentary evidence, satisfactory to the Buyer, of not
being subject to Mexican capital gains Tax), to the Buyer,
within the twenty (20) calendar days following the Closing
Date, for MDS Mexico to be able to record the Buyer as the new
owner of the Stockholders equity participation in the
Partners Registry Book of MDS Mexico without MDS Mexico
incurring joint liability with respect to the Stockholders
Mexican Tax obligations associated with the transfer of such
equity participation.
(g) The Parties intend that the Transaction shall
constitute a reorganization within the meaning of
Section 368(a)(1)(B) of the Code. The Parties adopt this
Agreement as a plan of reorganization within the
meaning of
Sections 1.368-2(g)
and 1.368-3(a) of the U.S. Income Tax Regulations.
ARTICLE X
REGISTRATION
RIGHTS
10.1 Piggyback
Registrations. Following the Closing Date, if
the Buyer proposes to register any Buyer Common Stock under the
Securities Act at any time (other than a registration statement
relating solely to employee benefit plans or a registration
relating to a Rule 145 transaction on
Form S-4
or similar forms promulgated in the future) and the registration
form to be used may be used for the registration of Buyer
Shares, whether or not for sale for Buyers own account,
the Buyer will give prompt written notice at least 30 days
prior to the anticipated effective date of the registration
statement relating to such registration (the Company
Registration) to the Stockholder. The Stockholder may
elect, for purposes of such Company Registration only, to have
all the rights and obligations of a Holder under
Section 2.3 of the Investor Rights Agreement solely with
respect to the Buyer Shares held by him, and, to the extent
applicable to Section 2.3 thereof only, Sections 2.5,
2.6, 2.7, 2.8, 2.9 and 2.11 of the Investor Rights Agreement;
provided, however, that under
Section 2.3(a) thereof the underwriters may reduce the
number of Buyer Shares to be included in such registration
statement to not less than 20% of the total number of Buyer
Shares requested to be included in such registration;
and, provided, further, that as a condition
to the Stockholders participation in such Company
Registration, the Stockholder must also agree not to sell any
shares of Buyer Common Stock held by the Stockholder from the
date of the filing of such registration statement until
30 days following the effective date of such registration
statement, other than in connection with such Company
Registration. For the avoidance of doubt, the Stockholder shall
have no rights or obligations in connection with any offering by
the Buyer nor shall he have any rights or obligations, as a
Holder or otherwise, under the Investor Rights Agreement.
10.2 Assignment of
Rights. The Stockholder may not assign any of
his rights under this Article X except in connection with
the transfer of some or all of the Buyer Shares to a child or
spouse, or trust for their benefit, provided each such
transferee agrees in a written instrument delivered to the Buyer
to be bound by the provisions of this Article X.
10.3 Legends. The Buyer
shall be entitled to place appropriate legends on the
certificates evidencing the Buyer Shares for purposes of
Rule 145 under the Securities Act reflecting the
restrictions set forth in Rule 145 and the restrictions
imposed by Section 8.4 and to issue appropriate stop
transfer instructions to the transfer agent for Buyer Common
Stock.
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ARTICLE XI
TERMINATION
11.1 Termination of
Agreement. The Stockholder and the Buyer may
terminate this Agreement prior to the Closing (whether before or
after Buyer Stockholder Approval), as provided below:
(a) the Stockholder and the Buyer may terminate this
Agreement by mutual written consent;
(b) the Buyer may terminate this Agreement by giving
written notice to the Stockholder in the event the Stockholder
is in breach of any representation, warranty or covenant
contained in this Agreement, and such breach
(i) individually or in combination with any other such
breach, would cause the conditions set forth in clauses (d)
or (e) of Section 6.1 not to be satisfied and
(ii) is not cured within 20 days following delivery by
the Buyer to the Stockholder of written notice of such breach;
(c) the Stockholder may terminate this Agreement by giving
written notice to the Buyer in the event the Buyer is in breach
of any representation, warranty or covenant contained in this
Agreement, and such breach (i) individually or in
combination with any other such breach, would cause the
conditions set forth in clauses (e) or (f) of
Section 6.2 not to be satisfied and (ii) is not cured
within 20 days following delivery by the Stockholder to the
Buyer of written notice of such breach;
(d) either the Buyer or the Stockholder may terminate this
Agreement by giving written notice to the other Party at any
time after the stockholders of the Buyer have voted on whether
to approve the issuance of the Buyer Shares in the event the
proposed issuance of the Buyer Shares failed to receive the
Buyer Stockholder Approval;
(e) the Buyer may terminate this Agreement by giving
written notice to the Stockholder if the Closing shall not have
occurred on or before December 31, 2007 by reason of the
failure of any condition precedent under Section 6.1
(unless the failure results primarily from a breach by the Buyer
of any representation, warranty or covenant contained in this
Agreement); or
(f) the Stockholder may terminate this Agreement by giving
written notice to the Buyer if the Closing shall not have
occurred on or before December 31, 2007 by reason of the
failure of any condition precedent under Section 6.2
(unless the failure results primarily from a breach by the
Stockholder of any representation, warranty or covenant
contained in this Agreement).
11.2 Effect of
Termination. If any Party terminates this
Agreement pursuant to Section 11.1, all obligations of the
Parties hereunder shall terminate without any liability of any
Party to any other Party (except for any liability of any Party
for willful breaches of this Agreement prior to such
termination); provided, that, in the event this
Agreement is terminated by either the Buyer or the Stockholder
pursuant to Section 11.1(d) hereof as a result of the Buyer
Boards modification or withdrawal of its recommendation to
the Buyers stockholders in accordance with
Section 5.3(b) hereof, the Buyer shall reimburse the
Stockholder for up to an aggregate of $600,000 in reasonable
documented expenses of the Stockholder actually incurred
relating to the transactions contemplated by this Agreement
prior to such termination (excluding any discretionary fees paid
to any financial advisors of the Stockholder or the Companies).
The expenses payable pursuant to this Section 11.2 shall be
paid by wire transfer of
same-day
funds within five (5) business days after demand therefor.
ARTICLE XII
DEFINITIONS
For purposes of this Agreement, each of the following terms
shall have the meaning set forth below.
Accountant shall mean an independent
accountant selected by the Stockholder and reasonably approved
by the Buyer.
Affiliate shall mean any affiliate, as
defined in
Rule 12b-2
under the Securities Exchange Act of 1934.
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Agreed Amount shall mean part, but not
all, of the Claimed Amount.
Agreement shall have the meaning set
forth in the first paragraph of this Agreement.
AIP shall have the meaning set forth
in Section 3.24(a).
Bankruptcy Exception means, in respect
of any agreement, contract or commitment, any limitation thereon
imposed by any bankruptcy, insolvency, fraudulent conveyance,
reorganization, moratorium or similar law affecting
creditors rights and remedies generally and, with respect
to the enforceability thereof, by general principles of equity,
including principles of commercial reasonableness, good faith
and fair dealing (regardless of whether enforcement is sought in
a proceeding at law or in equity).
Base Purchase Price shall have the
meaning set forth in Section 1.3.
Business Combination shall have the
meaning set forth in Section 8.4.
Buyer shall have the meaning set forth
in the first paragraph of this Agreement.
Buyer Assigned Patent shall have the
meaning set forth in Section 5.13.
Buyer Benefit Plans shall mean the
employee benefit plans, programs and policies of the Buyer and
its Affiliates.
Buyer Board shall have the meaning set
forth in Section 5.3(b).
Buyer Certificate shall mean a
certificate to the effect that each of the conditions specified
in clauses (a) through (g) (insofar as clause (g)
relates to Legal Proceedings involving the Buyer) of
Section 6.2 is satisfied in all respects.
Buyer Common Stock shall mean the
shares of voting common stock, $.001 par value per share,
of the Buyer.
Buyer Disclosure Schedule shall mean
the disclosure schedule provided by the Buyer to the Stockholder
on the date hereof and accepted in writing by the Stockholder.
Buyer Material Adverse Effect shall
mean any material adverse change, event, circumstance or
development with respect to, or any material adverse effect on,
(i) the business, assets, liabilities, capitalization,
condition (financial or other), or results of operations of the
Buyer and its Subsidiaries, taken as a whole or (ii) the
ability of the Buyer to consummate the transactions contemplated
by this Agreement. An adverse change in stock price of Buyer
Common Stock shall not, in and of itself, be deemed to have a
Buyer Material Adverse Effect.
Buyer Meeting shall have the meaning
set forth in Section 5.3(a).
Buyer Preferred Stock shall have the
meaning set forth in Section 4.2(a).
Buyer Reports shall mean (a) the
Buyers Annual Report on Form 10 K for the fiscal year
ended December 31, 2006, as filed with the SEC, and
(b) all other reports filed by the Buyer under
Section 13 or subsections (a) or (c) of
Section 14 of the Exchange Act with the SEC since
January 1, 2006.
Buyer Shares shall mean
6,500,000 shares of Buyer Common Stock.
Buyer Stock Option shall have the
meaning set forth in Section 4.2(b).
Buyer Stock Plans shall have the
meaning set forth in Section 4.2(b).
Buyer Stockholder Approval shall have
the meaning set forth in Section 4.3(d).
Buyer Warrants shall have the meaning
set forth in Section 4.2(c).
Cap Amount shall have the meaning set
forth in Section 7.5(a).
CBP shall have the meaning set forth
in Section 3.18.
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CERCLA shall mean the federal
Comprehensive Environmental Response, Compensation and Liability
Act of 1980, as amended.
Change in Control shall have the
meaning set forth in Section 8.4.
Claim Notice shall mean written
notification which contains (i) a description of the
Damages incurred or reasonably expected to be incurred by the
Indemnified Party and the Claimed Amount of such Damages, to the
extent then known, (ii) a statement that the Indemnified
Party is entitled to indemnification under Article VII for
such Damages and a reasonable explanation of the basis therefor,
and (iii) a demand for payment in the amount of such
Damages.
Claimed Amount shall mean the amount
of any Damages incurred or reasonably expected to be incurred by
the Indemnified Party.
Closing shall mean the closing of the
transactions contemplated by this Agreement.
Closing Date shall mean the date two
business days after the satisfaction or waiver of all of the
conditions to the obligations of the Parties to consummate the
transactions contemplated hereby (excluding the delivery at the
Closing of any of the documents set forth in Article VI),
or such other date as may be mutually agreeable to the Parties.
Closing Price shall mean the average
closing price of Buyer Common Stock for the five trading days
ending on the second trading day immediately preceding the
Closing, as reported by the NASDAQ Global Market.
Closing Value shall mean the average
of the last reported sale prices per share of the Buyer Common
Stock on the NASDAQ Global Market over the five consecutive
trading days ending two trading days before the Closing Date
(subject to equitable adjustment in the event of any stock
split, stock dividend, reverse stock split or similar event
affecting the Buyer Common Stock since the beginning of such
five-day
period), multiplied by the number of Buyer Shares.
Closing Working Capital shall mean as
of Closing, (i) total current assets of the Companies as of
such date, minus (ii) total current liabilities (including
accrued royalties) of the Companies as of such date, each as
calculated in accordance with GAAP.
Code shall mean the Internal Revenue
Code of 1986, as amended.
Companies shall mean MDS Services,
MDS, MDS Italy and MDS Mexico, collectively.
Company shall mean any of MDS
Services, MDS, MDS Italy and MDS Mexico.
Company Certificate shall mean a
certificate to the effect that each of the conditions specified
in clauses (a) through (f) (insofar as clause (f)
relates to Legal Proceedings involving any of the Companies) of
Section 6.1 is satisfied in all respects.
Company Disclosure Schedule shall mean
the disclosure schedule provided by the Stockholder to the Buyer
on the date hereof and accepted in writing by the Buyer.
Company Employees shall have the
meaning set forth in Section 8.8.
Company Intellectual Property shall
mean the Company Owned Intellectual Property and the Company
Licensed Intellectual Property.
Company Licensed Intellectual Property
shall mean all Intellectual Property that is licensed to any
of the Companies as of the Closing Date. For the avoidance of
doubt, Company Licensed Intellectual Property shall not include
any (a) Excluded Intellectual Property, and (b) any
Intellectual Property that is no longer licensed to any of the
Companies as of the Closing Date.
Company Material Adverse Effect shall
mean any material adverse change, event, circumstance or
development with respect to, or material adverse effect on,
(a) the business, assets, liabilities, capitalization,
condition (financial or other), or results of operations of the
Companies, taken as a whole, (b) the ability of
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the Stockholder or the Companies to consummate the transactions
contemplated by this Agreement, (c) the ability of the
Buyer to operate the businesses of the Companies immediately
after the Closing or (d) the ability of the officers of the
Buyer, following the Closing, to certify without qualification
to the Buyers financial statements or SEC reports as they
relate to the businesses or operations previously conducted by
the Companies; provided, that, in each case a
Company Material Adverse Effect shall not be deemed
to include effects or circumstances resulting from (i) any
changes in general economic, business, political or financial
conditions (except for any such change, event, circumstance,
development or effect that disproportionately affects the
Companies relative to other industry participants),
(ii) any changes in the industry in which the Companies
operate (except for any such change, event, circumstance,
development or effect that disproportionately affects the
Companies relative to other industry participants); or
(iii) the announcement of this Agreement or the
transactions contemplated hereby or the identity of the Buyer.
For the avoidance of doubt, the Parties agree that the terms
material, materially or
materiality as used in this Agreement with an
initial lower case m shall have their respective
customary and ordinary meanings, without regard to the meaning
ascribed to Company Material Adverse Effect.
Company Owned Intellectual Property
shall mean all Intellectual Property owned, in whole or in
part, by any of the Companies as of the Closing Date. For the
avoidance of doubt, Company Owned Intellectual Property shall
not include any (a) Excluded Intellectual Property, and
(b) any Intellectual Property that is no longer owned by
any of the Companies as of the Closing Date.
Company Plan shall mean any Employee
Benefit Plan maintained, or contributed to, by any of the
Companies or any ERISA Affiliate for the benefit of any current
or former employee of any of the Companies, but excluding
government-sponsored or government-affiliated Employee Benefit
Plans.
Company 401(k) Plan shall have the
meaning set forth in Section 8.8(b).
Company Registration shall have the
meaning set forth in Section 10.1.
Company Stock Plan shall mean any
stock option plan or other stock or equity-related plan of any
Company.
Consulting Agreement shall mean the
consulting agreement to be entered into by the Stockholder, DSU,
and the Buyer or an Affiliate thereof in the form attached
hereto as Exhibit C.
Continuing Employees shall have the
meaning set forth in Section 8.8.
Controlling Party shall mean the party
controlling the defense of any Third Party Action.
Damages shall mean any and all debts,
obligations and other liabilities (whether absolute, accrued,
contingent, fixed or otherwise, or whether known or unknown, or
due or to become due or otherwise), diminution in value,
monetary damages, fines, fees, penalties, interest obligations,
deficiencies, losses and expenses (including amounts paid in
settlement, interest, court costs, costs of investigators, fees
and expenses of attorneys, accountants, financial advisors and
other experts, and other expenses of litigation, arbitration or
other dispute resolution proceedings relating to a Third Party
Action or an indemnification claim under Article VII),
other than those fees and expenses of the Accountant set forth
in and governed by Section 1.5(b)(vi).
Deductible shall have the meaning set
forth in Section 7.5(a).
Determination Date shall mean
(a) the Objection Deadline Date, if no objection to the
Draft Closing Balance Sheet or the calculation of the Closing
Working Capital is made pursuant to Section 1.5(c),
(b) the date on which the Buyer receives notification from
the Stockholder that no objection to the Draft Closing Balance
Sheet and the calculation of the Closing Working Capital will be
made, or (c) the date on which final resolution of any
dispute in connection with the determination of the Closing
Working Capital pursuant to Section 1.5 is achieved.
Dispute shall mean the dispute
resulting if the Indemnifying Party in a Response disputes its
liability for all or part of the Claimed Amount.
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DGCL shall mean the General
Corporation Law of the State of Delaware.
Draft Closing Balance Sheet shall mean
the balance sheet of the Companies as of the Closing Date
prepared and delivered by the Buyer pursuant to
Section 1.5(a).
DSU shall mean DSU Medical
Corporation, a Nevada corporation.
Employee Benefit Plan shall mean any
employee pension benefit plan (as defined in
Section 3(2) of ERISA), any employee welfare benefit
plan (as defined in Section 3(1) of ERISA), and any
other written or oral plan, agreement or arrangement involving
direct or indirect compensation, including insurance coverage,
severance benefits, disability benefits, deferred compensation,
bonuses, stock options, stock purchase, phantom stock, stock
appreciation or other forms of incentive compensation or
post-retirement compensation.
Environmental Law shall mean
(a) any United States federal, state or local law, statute,
rule, order, directive, judgment, Permit or regulation or the
common law in effect up to and through the Closing Date relating
to the environment, occupational health and safety, the
potential toxic material content of any product or exposure of
persons or property to Materials of Environmental Concern passed
or issued by any Governmental Entity, including any statute,
regulation, administrative decision or order pertaining to:
(i) the presence of or the treatment, storage, disposal,
generation, transportation, manufacture, processing, use,
import, export, labeling, recycling, registration, investigation
or remediation of Materials of Environmental Concern or
documentation related to the foregoing; (ii) air, water and
noise pollution; (iii) groundwater and soil contamination;
(iv) the release, threatened release, or accidental release
into the environment, the workplace or other areas of Materials
of Environmental Concern, including emissions, discharges,
injections, spills, escapes or dumping of Materials of
Environmental Concern; (v) transfer of interests in or
control of real property which may be contaminated;
(vi) community or worker right-to-know disclosures with
respect to Materials of Environmental Concern; (vii) the
protection of wild life, marine life and wetlands, and
endangered and threatened species; (viii) storage tanks,
vessels, containers, abandoned or discarded barrels and other
closed receptacles; and (ix) health and safety of employees
and (b) any Mexican or Italian national, state, provincial
or local law, statute, rule, order, directive, judgment, Permit
or regulation or the common law in effect up to and through the
Closing Date analogous or comparable to the topics or issues set
forth in sub-section (a) of this definition. As used above,
the term release shall have the meaning set forth in
CERCLA.
ERISA shall mean the Employee
Retirement Income Security Act of 1974, as amended.
ERISA Affiliate shall mean any entity
which is, or at any applicable time was, a member of (1) a
controlled group of corporations (as defined in
Section 414(b) of the Code), (2) a group of trades or
businesses under common control (as defined in
Section 414(c) of the Code), or (3) an affiliated
service group (as defined under Section 414(m) of the Code
or the regulations under Section 414(o) of the Code), any
of which includes or included any of the Companies.
Escrow Agreement shall mean an escrow
agreement in substantially the form attached hereto as
Exhibit A.
Escrow Agent shall mean Computershare
Services, Inc.
Escrow Shares shall mean
1,000,000 shares of Buyer Common Stock.
Exchange Act shall mean the Securities
Exchange Act of 1934, as amended.
Excluded Intellectual Property shall
mean the Intellectual Property set forth in Exhibit C of
the License Agreement.
Expected Claim Notice shall mean a
notice that, as a result of a legal proceeding instituted by or
written claim made by a third party, an Indemnified Party
reasonably expects to incur Damages for which it is entitled to
indemnification under Article VII.
Exploit shall mean develop, design,
test, modify, make, use, sell, have made, used and sold, import,
reproduce, market, distribute, commercialize, support, maintain,
correct and create derivative works of.
FDA shall have the meaning set forth
in Section 3.24(a).
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FD&C Act shall have the meaning
set forth in Section 3.24(b).
Field shall have meaning set forth in
the License Agreement.
Final Closing Balance Sheet shall have
the meaning set forth in Section 1.5(b).
Final Closing Working Capital shall
have the meaning set forth in Section 1.5(b).
Financial Statements shall mean:
(a) the unaudited consolidated balance sheets and
statements of income, changes in stockholders equity and
cash flows of each of the Medisystems Operating Companies as at
December 31, 2006,
(b) the audited consolidated balance sheets and statements
of income, changes in stockholders equity and cash flows
of each of the Medisystems Operating Companies as at
December 31, 2005 and December 31, 2004, and
(c) the Most Recent Balance Sheet and the unaudited
consolidated statements of income, changes in stockholders
equity and cash flows for the three months ended as of the Most
Recent Balance Sheet Date.
Focused Assessments shall mean a Risk
Based Approach to Audit as set forth by CBP that
concentrates on a companys internal compliance procedures
while also addressing areas of risk identified by CBP.
GAAP shall mean United States
generally accepted accounting principles.
Governmental Entity shall mean any
court, arbitrational tribunal, administrative agency or
commission or other governmental or regulatory authority or
agency, including any central or local governmental,
administrative or judicial entity, body, agency, inspectorate or
office of any jurisdiction where any Company is based or
operates, as far as applicable mutatis mutandis.
Hart-Scott-Rodino Act shall mean the
Hart-Scott-Rodino
Antitrust Improvements Act of 1976, as amended.
HIPAA shall mean the Health Insurance
Portability and Accountability Act of 1996, Public Law
104-191.
Income Taxes shall mean any Taxes
imposed upon or measured by net income.
Indemnified Party shall mean a party
entitled, or seeking to assert rights, to indemnification under
Article VII.
Indemnifying Party shall mean the
party from whom indemnification is sought by the Indemnified
Party.
Intellectual Property shall mean the
following subsisting throughout the world:
(a) Patents;
(b) Trademarks and all goodwill in the Trademarks;
(c) copyrights, designs, data and database rights and
registrations and applications for registration thereof,
including moral rights of authors;
(d) inventions, invention disclosures, statutory invention
registrations, trade secrets and confidential business
information, know-how, manufacturing and product processes and
techniques, research and development information, financial,
marketing and business data, pricing and cost information,
business and marketing plans and customer and supplier lists and
information, whether patentable or nonpatentable, whether
copyrightable or noncopyrightable and whether or not reduced to
practice; and
(e) other proprietary rights relating to any of the
foregoing (including remedies against infringement thereof and
rights of protection of interest therein under the laws of all
jurisdictions).
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Investor Rights Agreement shall mean
the Investor Rights Agreement, dated as of June 30, 1999,
by and between the Buyer and the investors listed therein, as
the same may be amended from time to time (the Investor
Rights Agreement)
Laws and Regulations shall have the
meaning set forth in Section 3.24(a).
Lease shall mean any lease or sublease
pursuant to which any Company leases or subleases from another
party any real property.
Legal Proceeding shall mean any
action, suit, proceeding, claim, arbitration or investigation
before any Governmental Entity or before any arbitrator.
License Agreement shall mean the
license agreement entered into by DSU and MDS dated as of
June 1, 2007.
Licensed Class B Patents shall
have the meaning set forth in the License Agreement.
Materials of Environmental Concern
shall mean any: pollutants, contaminants or hazardous
substances (as such terms are defined under CERCLA), pesticides
(as such term is defined under the Federal Insecticide,
Fungicide and Rodenticide Act), solid wastes and hazardous
wastes (as such terms are defined under the Resource
Conservation and Recovery Act), other hazardous, radioactive or
toxic materials, oil, petroleum and petroleum products (and
fractions thereof), or any other material or chemical (or
article containing such material or chemical) listed or subject
to regulation under any law, statute, rule, regulation, order,
Permit, or directive passed or issued by any Governmental Entity
due to its potential, directly or indirectly, to harm the
environment, public health or worker health and safety.
Medisystems Employment Agreement shall
mean the Medisystems Employment Agreement between MDS or MDS
Services, on the one hand, and any employee of MDS or MDS
Services, on the other hand.
MDS Italy Employment Agreement shall
mean the MDS Italy Employment Agreement between MDS Italy,
on the one hand, and any employee of MDS Italy, on the other
hand.
MDS Mexico Employment Agreement shall
mean the MDS Mexico Employment Agreement between MDS Mexico, on
the one hand, and any employee of MDS Mexico, on the other hand.
Medisystems Operating Companies shall
mean collectively, the Companies, MRC, MTC (until May 31,
2007, the effective date of its merger into DSU), LifeStream
Medical Corporation, a Nevada corporation and Infusion Care
Services, Inc., a Delaware corporation.
Most Recent Balance Sheet shall mean
the unaudited consolidated balance sheet of the Companies as of
the Most Recent Balance Sheet Date.
Most Recent Balance Sheet Date shall
mean March 31, 2007.
MRC shall mean Medisystems Research
Corp., an Illinois corporation.
MTC shall mean Medisystems Technology
Corporation, a Nevada corporation.
Non-controlling Party shall mean the
party not controlling the defense of any Third Party Action.
Objection Deadline Date shall mean the
date 30 days after delivery by the Buyer to the Stockholder
of the Draft Closing Balance Sheet.
Option shall mean each option to
purchase or acquire shares of any Company, whether issued by a
Company pursuant to a Company Stock Plan or otherwise.
Ordinary Course of Business shall mean
the ordinary course of business consistent with past custom and
practice (including with respect to frequency and amount).
Parties shall mean the Buyer and the
Stockholder.
Patents shall mean all patents and
patent applications filed with the United States Patent and
Trademark office or other Governmental Entity.
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Permits shall mean all permits,
licenses, registrations, certificates, orders, approvals,
franchises, variances and similar rights issued by or obtained
from any Governmental Entity (including those issued or required
under Environmental Laws and those relating to the occupancy or
use of owned or leased real property).
Products shall have the meaning set
forth in Section 3.24(b).
Proxy Statement/Prospectus shall mean
the proxy statement/prospectus included as part of the
S-4
Registration Statement, together with any accompanying letter to
stockholders, notice of meeting and form of proxy or written
consent.
Public Filings shall have the meaning
set forth in Section 5.10(a).
Reasonable Best Efforts shall mean
best efforts, to the extent commercially reasonable.
Registered Company Intellectual Property
shall mean Registered Intellectual Property that is owned by
any Company as of the Closing Date or licensed to any Company
pursuant to the License Agreement.
Registered Intellectual Property shall
mean all Patents, registered Trademarks, registered copyrights
and designs, and all applications filed with the United States
Patent and Trademark Office and all foreign equivalent offices
for each of the foregoing.
Related Agreements shall mean the
Escrow Agreement, the Consulting Agreement, and the Stock
Transfer Documents.
Response shall mean a written response
containing the information provided for in Section 7.3(c).
SEC shall mean the Securities and
Exchange Commission.
S-4 Registration Statement shall mean
a registration statement of the Buyer on
Form S-4
for the purposes of (1) registering the Buyer Shares under
the Securities Act and (2) soliciting proxies from the
stockholders of the Buyer for the purpose of obtaining the
approval by the stockholders of the Buyer of the issuance of
shares of Buyer Common Stock pursuant to the terms of this
Agreement.
Securities Act shall mean the
Securities Act of 1933, as amended.
Security Interest shall mean any
mortgage, pledge, security interest, encumbrance, charge or
other lien (whether arising by contract or by operation of law),
other than (i) mechanics, materialmens, and
similar liens, (ii) liens arising under workers
compensation, unemployment insurance, social security,
retirement, and similar legislation and (iii) liens on
goods in transit incurred pursuant to documentary letters of
credit, in each case arising in the Ordinary Course of Business
of the applicable Company and not material to such Company.
Shares shall have the meaning set
forth in the Preliminary Statement of this Agreement.
Specified Sections shall have the
meaning set forth in Section 13.10.
Stock Transfer Documents shall have
the meaning set forth in Section 1.8.
Stockholder shall have the meaning set
forth in the first paragraph of this Agreement.
Stockholder Nominee shall have the
meaning set forth in Section 8.6.
Subsidiary shall mean any corporation,
partnership, trust, limited liability company, branch,
representative office or other non-corporate business enterprise
in which any Company holds stock or other ownership interests
representing (a) more than 50% of the voting power of all
outstanding stock or ownership interests of such entity or
(b) the right to receive more than 50% of the net assets of
such entity available for distribution to the holders of
outstanding stock or ownership interests upon a liquidation or
dissolution of such entity.
Target Amount shall equal negative
$1,850,000, which amount shall be increased by the sum of the
amount of the Companies net income plus depreciation plus
amortization for the period from January 1, 2007 through
the Closing Date and decreased by the sum of the amounts of
(a) the royalties payable under the
A-48
License Agreement, (b) the cash dividends payable pursuant
to Section 5.14(a)(ii) and (c) the amount of the
Companies capital expenditures permitted under the terms
of this Agreement for the period from January 1, 2007
through the Closing Date.
Taxes shall mean any and all taxes,
charges, fees, duties, contributions, levies or other similar
assessments or liabilities in the nature of a tax, including,
without limitation, income, gross receipts, corporation, ad
valorem, premium, value-added, net worth, capital stock, capital
gains, documentary, recapture, alternative or add-on minimum,
disability, estimated, registration, recording, excise, real
property, personal property, sales, use, license, lease,
service, service use, transfer, withholding, employment,
unemployment, insurance, social security, national insurance,
business license, business organization, environmental, workers
compensation, payroll, profits, severance, stamp, occupation,
windfall profits, customs duties, franchise and other taxes of
any kind whatsoever imposed by the United States of America or
any state, local or foreign government, or any agency or
political subdivision thereof, and any interest, fines,
penalties, assessments or additions to tax imposed with respect
to such items or any contest or dispute thereof.
Tax Returns shall mean any and all
reports, returns, declarations, extension requests or statements
relating to Taxes, including any schedule or attachment thereto
and any related or supporting workpapers or information with
respect to any of the foregoing, including any amendment thereof.
Third Party Action shall mean any suit
or proceeding by a person or entity other than a Party for which
indemnification may be sought by a Party under Article VII.
Trademarks shall mean all registered
trademarks and service marks, logos, Internet domain names,
corporate names and doing business designations and all
registrations and applications for registration of the
foregoing, common law trademarks and service marks and trade
dress.
Transaction shall have the meaning set
forth in the Preliminary Statement of this Agreement.
Transfer Taxes shall have the meaning
set forth in Section 9.1(e).
Unresolved Objections shall mean any
objections set forth in the Stockholders statement of
objections that remain unresolved 30 days after delivery of
such statement of objections.
Value of Escrow Shares shall have the
meaning set forth in Section 7.3(c).
Voting Stock shall have the meaning
set forth in Section 8.4.
Warrant shall mean each warrant or
other contractual right to purchase or acquire any shares of any
Company, provided that Options shall not be considered Warrants.
Working Capital Certificate shall have
the meaning set forth in Section 1.5(a).
ARTICLE XIII
MISCELLANEOUS
13.1 Press Releases and
Announcements. No Party shall issue any press
release or public announcement relating to the subject matter of
this Agreement without the prior written approval of the other
Parties; provided, however, that any Party may
make any public disclosure it believes in good faith is required
by applicable law, regulation or stock market rule (in which
case the disclosing Party shall use reasonable efforts to advise
the other Parties and provide them with a copy of the proposed
disclosure prior to making the disclosure).
13.2 No Third Party
Beneficiaries. This Agreement shall not
confer any rights or remedies upon any person other than the
Parties and their respective heirs, executors, personal and
legal representatives, successors and permitted assigns.
13.3 Entire Agreement;
Attachments. This Agreement, all Schedules
and Exhibits hereto, and all agreements and instruments to be
delivered by the Parties pursuant hereto represent the entire
understanding and agreement between the Parties hereto with
respect to the subject matter hereof and supersede all prior
oral
A-49
and written and all contemporaneous oral negotiations,
commitments and understandings between such Parties. If the
provisions of any Schedule or Exhibit to this Agreement are
inconsistent with the provisions of this Agreement, the
provisions of the Agreement shall prevail. The Exhibits and
Schedules attached hereto or to be attached hereafter are hereby
incorporated as integral parts of this Agreement.
13.4 Successors and
Assigns. This Agreement shall be binding upon
and inure to the benefit of the Parties hereto and their
respective heirs, executors, personal and legal representatives,
successors and assigns, except that the Buyer, on the one hand,
and the Stockholder, on the other hand, may not assign their
respective obligations hereunder without the prior written
consent of the other Party; provided, however,
that the Buyer may assign its rights to acquire all or any
portion of the Shares hereunder, to a subsidiary or Affiliate of
the Buyer. Any assignment in contravention of this provision
shall be void. No assignment shall release the Buyer or the
Stockholder from any obligation or liability under this
Agreement.
13.5 Notices. All notices,
requests, demands, claims, and other communications hereunder
shall be in writing. Any notice, request, demand, claim or other
communication hereunder shall be deemed duly delivered four
business days after it is sent by registered or certified mail,
return receipt requested, postage prepaid, or one business day
after it is sent for next business day delivery via a reputable
nationwide overnight courier service, in each case to the
intended recipient as set forth below:
|
|
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To the Buyer or any of the
Companies (following the Closing Date):
|
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NxStage Medical, Inc.
439 South Union Street
5th Floor, Lawrence, MA 01843
Attn: Chief Executive Officer
|
|
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With a copy to:
|
|
NxStage Medical, Inc.
439 South Union Street
5th Floor, Lawrence, MA 01843
Attn: General Counsel
|
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|
|
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Wilmer Hale
60 State Street
Boston, MA 02109
Attn: Susan Murley
|
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To the Stockholder:
|
|
David S. Utterberg
2033
1st
Avenue, #3
Seattle, WA 98121
|
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With a copy to:
|
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John A. Willett or
Christine D. Rogers
Arnold & Porter LLP
399 Park Avenue
New York, NY 10022-4690
|
Any Party may give any notice, request, demand, claim or other
communication hereunder using any other means (including
personal delivery, expedited courier, messenger service,
telecopy, ordinary mail or electronic mail), but no such notice,
request, demand, claim or other communication shall be deemed to
have been duly given unless and until it actually is received by
the party for whom it is intended. Any Party may change the
address to which notices, requests, demands, claims, and other
communications hereunder are to be delivered by giving the other
Parties notice in the manner herein set forth.
13.6 Governing Law. All
matters arising out of or relating to this Agreement and the
transactions contemplated hereby (including without limitation
its interpretation, construction, performance and enforcement)
shall be governed by and construed in accordance with the
internal laws of Delaware without giving effect to any choice or
conflict of law provision or rule (whether of Delaware or any
other jurisdiction) that would cause the application of laws of
any jurisdictions other than those of Delaware.
13.7 Amendments and
Waivers. The Buyer, by the consent of its
Board of Directors or officers authorized by such Board, and the
Stockholder may amend or modify this Agreement, in such manner
as may be agreed upon, by a written instrument executed by the
Buyer and the Stockholder. No waiver of any right or
A-50
remedy hereunder shall be valid unless the same shall be in
writing and signed by the Party giving such waiver. No waiver by
any Party with respect to any default, misrepresentation or
breach of warranty or covenant hereunder shall be deemed to
extend to any prior or subsequent default, misrepresentation or
breach of warranty or covenant hereunder or affect in any way
any rights arising by virtue of any prior or subsequent such
occurrence.
13.8 Severability. Any term
or provision of this Agreement that is invalid or unenforceable
in any situation in any jurisdiction shall not affect the
validity or enforceability of the remaining terms and provisions
hereof or the validity or enforceability of the offending term
or provision in any other situation or in any other
jurisdiction. If the final judgment of a court of competent
jurisdiction declares that any term or provision hereof is
invalid or unenforceable, the Parties agree that the court
making the determination of invalidity or unenforceability shall
have the power to limit the term or provision, to delete
specific words or phrases, or to replace any invalid or
unenforceable term or provision with a term or provision that is
valid and enforceable and that comes closest to expressing the
intention of the invalid or unenforceable term or provision, and
this Agreement shall be enforceable as so modified.
13.9 Submission to
Jurisdiction. Each Party (a) submits to
the jurisdiction of any state or federal court sitting in the
State of Delaware in any action or proceeding arising out of or
relating to this Agreement, (b) agrees that all claims in
respect of such action or proceeding may be heard and determined
in any such court, (c) waives any claim of inconvenient
forum or other challenge to venue in such court, (d) agrees
not to bring any action or proceeding arising out of or relating
to this Agreement in any other court and (e) waives any
right it may have to a trial by jury with respect to any action
or proceeding arising out of or relating to this Agreement. Each
Party agrees to accept service of any summons, complaint or
other initial pleading made in the manner provided for the
giving of notices in Section 13.5, provided that nothing in
this Section 13.9 shall affect the right of any Party to
serve such summons, complaint or other initial pleading in any
other manner permitted by law.
13.10 Specific
Performance. Each Party acknowledges and
agrees that the other Party or Parties would be damaged
irreparably in the event any of the provisions contained in
Article I or any of Sections 5.2, 5.3, 5.7, 5.10,
5.12, 5.13, 8.1, 8.2, 8.4, 8.5, 8.6 and 8.7 (the Specified
Sections) of this Agreement are not performed in accordance with
their specific terms or otherwise are breached. Accordingly,
each Party agrees that the other Party or Parties may be
entitled to an injunction or injunctions to prevent breaches of
the provisions contained in Article I and the Specified
Sections of this Agreement and to enforce specifically the terms
and provisions of Article I and the Specified Sections in
any action instituted in any court of the United States or any
state thereof having jurisdiction over the Parties and the
matter.
13.11 Section Headings. The
section headings are for the convenience of the Parties and in
no way alter, modify, amend, limit, or restrict the contractual
obligations of the Parties.
13.12 Governing Document. To
the extent of any inconsistency between this Agreement and the
Stock Transfer Documents, the provisions of this Agreement shall
govern.
13.13 Exchange Rates. To the
extent that any U.S. dollar amounts need to be converted
into local currency as a result of the transactions contemplated
by this Agreement, the Parties shall use the currency exchange
trading among banks of $1 million and more rate
published in The Wall Street Journal on the first
business day prior to the Closing.
13.14 Counterparts and Facsimile
Signature. This Agreement may be executed in
two or more counterparts, each of which shall be deemed an
original but all of which together shall constitute one and the
same instrument. This Agreement may be executed by facsimile
signature.
[Signatures
appear on following page]
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IN WITNESS WHEREOF, the Parties have executed this Agreement as
of the date first above written.
BUYER:
NXSTAGE MEDICAL, INC.
By: /s/ Jeffrey H. Burbank
Title: President and CEO
STOCKHOLDER:
/s/ David S. Utterberg
David S. Utterberg
A-52
AMENDMENT
NO. 1 TO STOCK PURCHASE AGREEMENT
This Amendment No. 1
(the Amendment) to the Stock Purchase
Agreement dated as of June 4, 2007 (the
Agreement), between NxStage Medical Inc., a Delaware
corporation (Buyer), and David S. Utterberg (the
Stockholder) is entered into as of August 27,
2007 by the Buyer and the Stockholder. Capitalized terms used
but not defined herein shall have the meanings assigned to them
in the Agreement.
Introduction
WHEREAS, the Buyer and the Stockholder desire to amend the
Agreement pursuant hereto to reflect, among other things,
certain changes to the obligations of the Buyer under the
Agreement and certain changes to the rights of the Stockholder
under the Agreement.
NOW, THEREFORE, in consideration of the mutual promises and
covenants contained in this Amendment and other good and
valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the parties hereto, intending to be legally
bound, agree as follows:
1. Amendments. Each of the
Buyer and the Stockholder agree to the following amendments to
the Agreement:
(a) Clause (ii) of Section 4.3(c) is hereby
deleted in its entirety and replaced with the following:
[Intentionally Omitted]
(b) Section 5.3(a) is hereby amended and restated to
read in its entirety as follows:
Section 5.3 Special Meeting and
Proxy Statement.
(a) The Buyer shall use its Reasonable Best Efforts to
obtain, as promptly as practicable, the approval of the issuance
of shares of Buyer Common Stock pursuant to the terms of this
Agreement by the stockholders of the Buyer at a special meeting
of the stockholders of the Buyer (the Buyer
Meeting), as required by the rules of the NASDAQ Global
Market, in accordance with the applicable requirements of the
DGCL. In connection therewith, the Buyer shall prepare, with the
assistance and cooperation of the Stockholder, the Proxy
Statement. The Buyer shall file the preliminary Proxy Statement
with the SEC and shall, with the assistance of the Stockholder,
promptly respond to any SEC comments. Promptly following such
response and any applicable waiting period pursuant to SEC
rules, the Buyer shall file the definitive proxy statement with
the SEC and shall distribute the definitive Proxy Statement to
its stockholders.
(c) Section 5.3(c) is hereby amended and restated to
read in its entirety as follows:
The Buyer shall ensure that the Proxy Statement does not
contain an untrue statement of a material fact or omit to state
a material fact required to be stated therein or necessary to
make the statements therein not misleading (provided that the
Buyer shall not be responsible for the accuracy or completeness
of any information relating to the Stockholder or any of the
Companies or furnished by the Stockholder or any of the
Companies in writing for inclusion in the Proxy Statement).
(d) Section 5.3(d) is hereby amended and restated to
read in its entirety as follows:
The Stockholder shall, and shall cause the Companies to,
ensure that any information relating to any of them or furnished
by any of them to the Buyer in writing for inclusion in the
Proxy Statement does not contain an untrue statement of material
fact or omit to state a material fact required to be stated
therein or necessary to make the statements therein not
misleading.
(e) Section 5.3(e) is hereby inserted to read in its
entirety as follows:
If the Stockholder is no longer a director of the Buyer at
the time the Shares are to be issued pursuant to the Agreement,
the Stockholder shall confirm in writing to the Buyer his status
as an Accredited Investor (as defined in Rule 501 under the
Securities Act) in such form as is reasonably requested by the
Buyer.
A-53
(f) Subpart A of clause (v) of Section 5.10(a) is
hereby amended and restated to read in its entirety as follows:
(A) cooperate with and assist the Buyer in preparing
financial statements with respect to the businesses of the
Companies for inclusion by the Buyer in the Public Filings,
including in compliance with the applicable provisions of
Regulation S-X,
Form 8-K,
Form S-3
and Schedule 14A
(g) The text of Section 6.2(b) is deleted in its
entirety and replaced with the following: the issuance of
the Buyer Shares to the Stockholder pursuant to the terms of
this Agreement shall have obtained the Buyer Stockholder
Approval;
(h) Section 10.3 is hereby amended and restated to
read in its entirety as follows:
Legends. The Buyer Shares shall
be issued in a transaction exempt from registration under the
Securities Act of 1933, as amended, by reason of
Section 4(2) thereof. The Buyer shall be entitled to place
appropriate legends on the certificates evidencing the Buyer
Shares for purposes of Rule 144 under the Securities Act
reflecting the restrictions set forth in Rule 144 and the
restrictions imposed by Section 8.4 and to issue
appropriate stop transfer instructions to the transfer agent for
Buyer Common Stock.
(i) Section 10.4 is hereby inserted to read in its
entirety as follows:
Resale Registration
Statement. If, prior to the time the holding
period under Rule 144(k) promulgated under the Securities
Act has lapsed as to the Buyer Shares, the Stockholder ceases to
be an affiliate of the Buyer, the Buyer agrees to file, at the
Stockholders request and with his cooperation, a
registration statement registering for resale any Buyer Shares
then held by the Stockholder, and to use its Reasonable Best
Efforts to have the registration statement declared effective
under the Securities Act as promptly as practicable;
provided, however, the Buyer shall not be required
to file any such registration statement prior to the first
anniversary of the Closing. For purposes of this
Section 10.4, the Stockholder agrees that he will continue
to be considered an affiliate at least for so long as he
continues to remain a director of the Buyer
and/or
beneficially owns 10% or more of the outstanding shares of Buyer
Common Stock.
(j) ARTICLE XII DEFINITIONS is hereby
amended as follows:
(i) The definition of Proxy
Statement/Prospectus is amended and restated to read in
its entirety as follows:
Proxy Statement shall mean
the proxy statement soliciting proxies from the stockholders of
the Buyer for the purpose of obtaining the approval by the
stockholders of the Buyer of the issuance of shares of Buyer
Common Stock pursuant to the terms of this Agreement together
with any accompanying letter to stockholders, notice of meeting
and form of proxy or written consent.
and all appearances of Proxy Statement/Prospectus in
the Agreement (unless otherwise explicitly modified by this
Amendment) shall mean and refer to Proxy Statement.
(ii) The definition of
S-4
Registration Statement is deleted in its entirety.
2. Entire Agreement. By
execution of this Amendment, the Buyer and the Stockholder
executing the same, constituting all parties under the
Agreement, agree that the provisions set forth in the Agreement
are hereby amended as set forth herein. The Agreement, as
amended by this Amendment, contains the entire agreement among
the parties with respect to the subject matter thereof and
hereof. Except to the extent amended hereby, all of the terms,
provisions and conditions of the Agreement are hereby ratified
and confirmed and shall remain in full force and effect as of
the date specified therein.
A-54
3. Counterparts. This
Amendment may be executed in any number of counterparts by
original or facsimile signature, each such counterpart shall be
an original instrument, and all such counterparts together shall
constitute one and the same agreement.
[Remainder
of page intentionally left blank]
A-55
The parties have executed this Amendment as of the day and year
first written above.
NxStage Medical, Inc.
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By:
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/s/ Jeffrey
H. Burbank
Name: Jeffrey
H. Burbank
Title: President and CEO
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/s/ David
S. Utterberg
David
S. Utterberg
A-56
ANNEX B
Investment Banking
Corporate and Institutional
Client Group
World Financial Center
North Tower
New York, New York 10281-1330
212 449 1000 Main
June 4, 2007
Board of Directors
NxStage Medical, Inc.
439 South Union Street
Lawrence, MA 01843
Members of the Board of Directors:
NxStage Medical, Inc. (the Acquiror), and David S.
Utterberg (the Seller) are entering into a Stock
Purchase Agreement dated as of June 4, 2007 (the
Agreement), pursuant to which the Acquiror will
purchase, directly or indirectly, all of the issued and
outstanding shares of each of Medisystems Services Corporation
(MDS Services), Medisystems Corporation
(MDS), Medisystems Europe S.p.A. (MDS
Italy) and Medimexico s. de R.L. de C.V. (MDS
Mexico and, together with MDS Services, MDS and MDS Italy,
the Companies) for consideration (the
Consideration) consisting of 6,500,000 shares
of Common Stock, $0.001 par value, of the Acquiror (the
Acquiror Shares), subject to adjustment if the Final
Closing Working Capital (as defined in the Agreement) is greater
or less by $250,000 or more than the Target Amount (as defined
in the Agreement). The acquisition transaction contemplated by
the Agreement is referred to herein as the
Transaction.
You have asked us whether, in our opinion, the Consideration to
be paid by the Acquiror pursuant to the Transaction is fair from
a financial point of view to the Acquiror.
In arriving at the opinion set forth below, we have, among other
things:
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(1)
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Reviewed certain publicly available business and financial
information relating to the Acquiror that we deemed to be
relevant;
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(2)
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Reviewed certain information, including financial forecasts,
relating to the business, earnings, cash flow, assets,
liabilities and prospects of the Companies and the Acquiror;
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(3)
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Conducted discussions with members of senior management of the
Companies and the Acquiror concerning the matters described in
clauses 1 and 2 above, as well as their respective
businesses and prospects before and after giving effect to the
Transaction;
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(4)
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Reviewed the market prices and valuation multiples for the
Acquiror Shares and for certain publicly traded companies that
we deemed to be relevant;
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(5)
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Reviewed the results of operations of the Companies and compared
them with those of certain publicly traded companies that we
deemed to be relevant;
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(6)
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Compared the proposed financial terms of the Transaction with
the financial terms of certain other transactions that we deemed
to be relevant;
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(7)
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Participated in certain discussions and negotiations among
representatives of the Companies and the Acquiror and their
financial and legal advisors;
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(8)
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Reviewed the potential pro forma impact of the Transaction on
the Acquiror;
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(9)
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Reviewed the Agreement, the License Agreement dated June 1,
2007 between DSU Medical Corporation (DSU) and MDS,
and the form of Consulting Agreement to be entered into by and
among the Acquiror, DSU and the Seller (the Consulting
Agreement); and
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(10)
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Reviewed such other financial studies and analyses and took into
account such other matters as we deemed necessary, including our
assessment of general economic, market and monetary conditions.
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In preparing our opinion, we have assumed and relied on the
accuracy and completeness of all information supplied or
otherwise made available to us, discussed with or reviewed by or
for us, or publicly available, and we have not assumed any
responsibility for independently verifying such information or
undertaken an independent evaluation or appraisal of any of the
assets or liabilities of the Companies or the Acquiror, or been
furnished with any such evaluation or appraisal, nor have we
evaluated the solvency or fair value of the Companies or the
Acquiror under any state or federal laws relating to bankruptcy,
insolvency or similar matters. In addition, we have not assumed
any obligation to conduct any physical inspection of the
properties or facilities of the Companies or the Acquiror. With
respect to the financial forecast information furnished to or
discussed with us by the Companies or the Acquiror, we have
assumed that they have been reasonably prepared and reflect the
best currently available estimates and judgement of the
Companies or the Acquirors management as to the
expected future financial performance of the Companies or the
Acquiror, as the case may be.
Our opinion is necessarily based upon market, economic and other
conditions as they exist and can be evaluated on, and on the
information made available to us as of, the date hereof. We have
assumed that in the course of obtaining the necessary regulatory
or other consents or approvals (contractual or otherwise) for
the Transaction, no restrictions, including any divestiture
requirements or amendments or modifications, will be imposed
that will have a material adverse effect on the contemplated
benefits of the Transaction. We have also assumed that the
representations and warranties of each party contained in the
Agreement are true and correct as of the date of the Agreement,
that each party will perform all of its respective covenants and
agreements contained in the Agreement and that the Transaction
will be consummated in accordance with the terms of the
Agreement without waiver, modification or amendment. We are not
rendering any accounting, legal, tax or intellectual property
advice and understand that the Acquiror is relying upon its own
accounting, legal, tax and intellectual property advisors as to
accounting, legal, tax and intellectual property matters in
connection with the Transaction.
We are acting as financial advisor to the Acquiror in connection
with the Transaction and will receive a fee from the Acquiror
for our services, which is contingent upon the consummation of
the Transaction. In addition, the Acquiror has agreed to
indemnify us for certain liabilities arising out of our
engagement. We have, in the past, provided financial advisory
and financing services to the Acquiror and may continue to do so
and have received, and may receive, fees for the rendering of
such services. In addition, in the ordinary course of our
business, we may actively trade securities of the Acquiror for
our own account and for the accounts of customers and,
accordingly, may at any time hold a long or short position in
such securities.
This opinion is for the use and benefit of the Board of
Directors of the Acquiror. Our opinion does not address the
merits of the underlying decision by the Acquiror to engage in
the Transaction and does not constitute a recommendation to any
stockholder of the Acquiror as to how such stockholder should
vote on the issuance of the Acquiror Shares contemplated by the
Agreement or any matter related thereto. In addition, you have
not asked us to address, and this opinion does not address, the
fairness to, or any other consideration of, the holders of any
class of securities, creditors or other constituencies of the
Acquiror.
We are not expressing any opinion herein as to the prices at
which the Acquiror Shares will trade following the announcement
or consummation of the Transaction.
On the basis of and subject to the foregoing, we are of the
opinion that, as of the date hereof, the Consideration to be
paid by the Acquiror pursuant to the Transaction is fair from a
financial point of view to the Acquiror.
Very truly yours,
/s/ Merrill
Lynch, Pierce, Fenner & Smith Incorporated
MERRILL LYNCH, PIERCE, FENNER & SMITH
INCORPORATED
ANNEX C
AMENDMENT
NO. 1 TO
2005 STOCK INCENTIVE PLAN
OF
NxSTAGE MEDICAL, INC.
The 2005 Stock Incentive Plan (the Plan) of NxStage
Medical, Inc. is hereby amended as follows:
Section 4(a) is deleted in its entirety and the following
is substituted in its place:
(a) Number of Shares. Subject to adjustment
under Section 9, Awards may be made under the Plan for up
to an aggregate of 7,401,457 shares of common stock,
$0.001 par value per share, of the Company (the
Common Stock); provided, however, that of the
3,800,000 shares of Common Stock added to the Plan as of
the Stockholder Approval Date, the maximum number of shares with
respect to which Restricted Stock, Restricted Stock Units and
Other Stock-Based Awards may be granted shall be 1,500,000.
For purposes of counting the number of shares available for the
grant of Awards under the Plan and under the sublimits contained
in Section 4(a) and 4(b), (i) all shares of Common
Stock covered by independent SARs shall be counted against the
number of shares available for the grant of Awards; provided,
however, that independent SARs that may be settled in cash only
shall not be so counted; (ii) if any Award (A) expires
or is terminated, surrendered or canceled without having been
fully exercised or is forfeited in whole or in part (including
as the result of shares of Common Stock subject to such Award
being repurchased by the Company at the original issuance price
pursuant to a contractual repurchase right) or (B) results
in any Common Stock not being issued (including as a result of
an independent SAR that was settleable either in cash or in
stock actually being settled in cash), the unused Common Stock
covered by such Award shall again be available for the grant of
Awards; provided, however, in the case of Incentive Stock
Options (as hereinafter defined), the foregoing shall be subject
to any limitations under the Code; and provided further, in the
case of independent SARs, that the full number of shares subject
to any stock-settled SAR shall be counted against the shares
available under the Plan and against the sublimits listed in the
first clause of this Section regardless of the number of shares
actually used to settle such SAR upon exercise;
(iii) shares of Common Stock tendered to the Company by a
Participant to (A) purchase shares of Common Stock upon the
exercise of an Award or (B) satisfy tax withholding
obligations (including shares retained from the Award creating
the tax obligation) shall not be added back to the number of
shares available for the future grant of Awards; and
(iv) shares of Common Stock repurchased by the Company on
the open market using the proceeds from the exercise of an Award
shall not increase the number of shares available for future
grant of Awards.
Section 5(c) is deleted in its entirety and the following
is substituted in its place:
(c) Exercise Price. The Board shall establish
the exercise price of each Option and specify the exercise price
in the applicable option agreement. The exercise price shall be
not less than 100% of the Fair Market Value (as defined below)
on the date the Option is granted; provided that if the Board
approves the grant of an Option with an exercise price to be
determined on a future date, the exercise price shall be not
less than 100% of the Fair Market Value on such future date. The
Fair Market Value of a share of Common Stock for
purposes of the Plan will be determined as follows: (i) if
the Common Stock trades on a national securities exchange, the
closing sale price (for the primary trading session) on the date
of grant; or (ii) if the Common Stock does not trade on any
such exchange, the average of the closing bid and asked prices
as reported by an authorized OTCBB market data vendor as listed
on the OTCBB website (otcbb.com) on the date of grant; or
(iii) if the Common Stock is not publicly traded, the Board
will determine the Fair Market Value for purposes of the Plan
using any measure of value it determines to be appropriate
(including, as it considers appropriate, relying on appraisals)
in a manner consistent with the valuation principles under Code
Section 409A, except as the Board or Committee may
expressly determine otherwise.
C-1
Section 5(d) is deleted in its entirety and the following
is substituted in its place:
(d) Duration of Options. Each Option
shall be exercisable at such times and subject to such terms and
conditions as the Board may specify in the applicable option
agreement; provided, however, that no Option will be granted
with a term in excess of 10 years.
A new Section 5(h) is hereby added to the Plan, as follows:
(h) Limitation on Repricing. Unless such
action is approved by the Companys stockholders:
(1) no outstanding Option granted under the Plan may be
amended to provide an exercise price per share that is lower
than the then-current exercise price per share of such
outstanding Option (other than adjustments pursuant to
Section 9) and (2) the Board may not cancel or
repurchase for cash any outstanding option (whether or not
granted under the Plan) and grant in substitution therefor new
Awards under the Plan covering the same or a different number of
shares of Common Stock and having an exercise price per share
lower than the then-current exercise price per share of the
cancelled option.
A new Section 6(d) is hereby added to the Plan, as follows:
(d) Exercise Price. The Board shall
establish the exercise price of each SAR and specify the
exercise price in the applicable SAR agreement. The exercise
price shall not be less than 100% of the Fair Market Value of
our common stock on the date the SAR is granted; provided that
if the Board approves the grant of a SAR with an exercise price
to be determined on a future date, the exercise price shall be
not less than 100% of the Fair Market Value of our common stock
on such future date.
A new Section 6(e) is hereby added to the Plan, as follows:
(e) Limitation on Repricing. Unless such
action is approved by the Companys stockholders:
(1) no outstanding SAR granted under the Plan may be
amended to provide a exercise price per share that is lower than
the then-current exercise price per share of such outstanding
SAR (other than adjustments pursuant to Section 9) and
(2) the Board may not cancel any outstanding SAR (whether
or not granted under the Plan) and grant in substitution
therefor new Awards under the Plan covering the same or a
different number of shares of Common Stock and having a exercise
price per share lower than the then-current exercise price per
share of the cancelled SAR.
Except as set forth above, the remainder of the Plan remains in
full force and effect.
Adopted by the Board of Directors on July 25, 2007.
Adopted by the Stockholders
on ,
2007
(the Stockholder Approval Date)
C-2
NxSTAGE
MEDICAL, INC.
2005 STOCK INCENTIVE PLAN
The purpose of this 2005 Stock Incentive Plan (the
Plan) of NxStage Medical, Inc., a Delaware
corporation (the Company), is to advance the
interests of the Companys stockholders by enhancing the
Companys ability to attract, retain and motivate persons
who are expected to make important contributions to the Company
and by providing such persons with equity ownership
opportunities and performance-based incentives that are intended
to align their interests with those of the Companys
stockholders. Except where the context otherwise requires, the
term Company shall include any of the Companys
present or future parent or subsidiary corporations as defined
in Sections 424(e) or (f) of the Internal Revenue Code
of 1986, as amended, and any regulations promulgated thereunder
(the Code) and any other business venture
(including, without limitation, joint venture or limited
liability company) in which the Company has a controlling
interest, as determined by the Board of Directors of the Company
(the Board).
All of the Companys employees, officers, directors,
consultants and advisors are eligible to receive options, stock
appreciation rights, restricted stock, restricted stock units
and other stock-based awards (each, an Award) under
the Plan. Each person who receives an Award under the Plan is
deemed a Participant.
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3.
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Administration
and Delegation
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(a) Administration by Board of
Directors. The Plan will be administered by the
Board. The Board shall have authority to grant Awards and to
adopt, amend and repeal such administrative rules, guidelines
and practices relating to the Plan as it shall deem advisable.
The Board may correct any defect, supply any omission or
reconcile any inconsistency in the Plan or any Award in the
manner and to the extent it shall deem expedient to carry the
Plan into effect and it shall be the sole and final judge of
such expediency. All decisions by the Board shall be made in the
Boards sole discretion and shall be final and binding on
all persons having or claiming any interest in the Plan or in
any Award. No director or person acting pursuant to the
authority delegated by the Board shall be liable for any action
or determination relating to or under the Plan made in good
faith.
(b) Appointment of Committees. To the
extent permitted by applicable law, the Board may delegate any
or all of its powers under the Plan to one or more committees or
subcommittees of the Board (a Committee). All
references in the Plan to the Board shall mean the
Board or a Committee of the Board to the extent that the
Boards powers or authority under the Plan have been
delegated to such Committee.
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4.
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Stock
Available for Awards
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(a) Number of Shares. Subject to
adjustment under Section 9, Awards may be made under the
Plan for up to the number of shares of common stock,
$0.001 par value per share, of the Company (the
Common Stock) that is equal to the sum of:
(1) such number of shares of Common Stock as is equal to
the sum of (x) the number of shares of Common Stock reserved for
issuance under the Companys 1999 Stock Option and Grant
Plan (the Existing Plan) that remain available for
grant under the Existing Plan immediately prior to the closing
of the Companys initial public offering and (y) the
number of shares of Common Stock subject to awards granted under
the Existing Plan which awards expire, terminate or are
otherwise surrendered, canceled, forfeited or repurchased by the
Company at their original issuance price pursuant to a
contractual repurchase right (subject, however, in the case of
Incentive Stock Options (as hereinafter defined) to any
limitations of the Code); plus
(2) an annual increase to be added on the first day of each
of the Companys fiscal years during the period beginning
in fiscal year 2007 and ending on the second day of fiscal year
2015 equal to the lesser
C-3
of (i) 600,000 shares of Common Stock, (ii) 3% of
the outstanding shares on such date or (ii) an amount
determined by the Board.
Notwithstanding clause (2) above, in no event shall the
number of shares available under this Plan be increased as set
forth in clause (2) to the extent such increase, in
addition to any other increases proposed by the Board in the
number of shares available for issuance under all other employee
or director stock plans, would result in the total number of
shares then available for issuance under all employee and
director stock plans exceeding 30% of the outstanding shares of
the Company on the first day of the applicable fiscal year.
If any Award expires or is terminated, surrendered or canceled
without having been fully exercised or is forfeited in whole or
in part (including as the result of shares of Common Stock
subject to such Award being repurchased by the Company at the
original issuance price pursuant to a contractual repurchase
right) or results in any Common Stock not being issued, the
unused Common Stock covered by such Award shall again be
available for the grant of Awards under the Plan. Further,
shares of Common Stock tendered to the Company by a Participant
to exercise an Award shall be added to the number of shares of
Common Stock available for the grant of Awards under the Plan.
However, in the case of Incentive Stock Options (as hereinafter
defined), the foregoing provisions shall be subject to any
limitations under the Code. Shares issued under the Plan may
consist in whole or in part of authorized but unissued shares or
treasury shares.
(b) Per-Participant Limit. Subject to
adjustment under Section 9, for Awards granted after the
Common Stock is registered under the Securities Exchange Act of
1934 (the Exchange Act), the maximum number of
shares of Common Stock with respect to which Awards may be
granted to any Participant under the Plan shall be 1,000,000(1)
per calendar year. For purposes of the foregoing limit, the
combination of an Option in tandem with an SAR (as each is
hereafter defined) shall be treated as a single Award. The
per-Participant limit described in this Section 4(b) shall
be construed and applied consistently with Section 162(m)
of the Code or any successor provision thereto, and the
regulations thereunder (Section 162(m)).
(a) General. The Board may grant options
to purchase Common Stock (each, an Option) and
determine the number of shares of Common Stock to be covered by
each Option, the exercise price of each Option and the
conditions and limitations applicable to the exercise of each
Option, including conditions relating to applicable federal or
state securities laws, as it considers necessary or advisable.
An Option which is not intended to be an Incentive Stock Option
(as hereinafter defined) shall be designated a
Nonstatutory Stock Option.
(b) Incentive Stock Options. An Option
that the Board intends to be an incentive stock
option as defined in Section 422 of the Code (an
Incentive Stock Option) shall only be granted to
employees of NxStage, any of NxStages present or future
parent or subsidiary corporations as defined in
Sections 424(e) or (f) of the Code, and any other
entities the employees of which are eligible to receive
Incentive Stock Options under the Code, and shall be subject to
and shall be construed consistently with the requirements of
Section 422 of the Code. The Company shall have no
liability to a Participant, or any other party, if an Option (or
any part thereof) that is intended to be an Incentive Stock
Option is not an Incentive Stock Option or for any action taken
by the Board pursuant to Section 10(f), including without
limitation the conversion of an Incentive Stock Option to a
Nonstatutory Stock Option.
(c) Exercise Price. The Board shall
establish the exercise price of each Option and specify such
exercise price in the applicable option agreement.
(d) Duration of Options. Each Option
shall be exercisable at such times and subject to such terms and
conditions as the Board may specify in the applicable option
agreement.
(e) Exercise of Option. Options may be
exercised by delivery to the Company of a written notice of
exercise signed by the proper person or by any other form of
notice (including electronic notice) approved by the Board
together with payment in full as specified in Section 5(f)
for the number of shares for which the Option is exercised.
Shares of Common Stock subject to the Option will be delivered
by the Company following exercise either as soon as practicable
or, subject to such conditions as the Board shall specify, on a
C-4
deferred basis (with the Companys obligation to be
evidenced by an instrument providing for future delivery of the
deferred shares at the time or times specified by the Board).
(1) After giving effect to the proposed reverse stock split
of the Companys Common Stock in anticipation of the
initial public offering.
(f) Payment Upon Exercise. Common Stock
purchased upon the exercise of an Option granted under the Plan
shall be paid for as follows:
(1) in cash or by check, payable to the order of the
Company;
(2) except as the Board may otherwise provide in an option
agreement, by (i) delivery of an irrevocable and
unconditional undertaking by a creditworthy broker to deliver
promptly to the Company sufficient funds to pay the exercise
price and any required tax withholding or (ii) delivery by
the Participant to the Company of a copy of irrevocable and
unconditional instructions to a creditworthy broker to deliver
promptly to the Company cash or a check sufficient to pay the
exercise price and any required tax withholding;
(3) when the Common Stock is registered under the Exchange
Act, by delivery of shares of Common Stock owned by the
Participant valued at their fair market value as determined by
(or in a manner approved by) the Board (Fair Market
Value), provided (i) such method of payment is then
permitted under applicable law, (ii) such Common Stock, if
acquired directly from the Company, was owned by the Participant
for such minimum period of time, if any, as may be established
by the Board in its discretion and (iii) such Common Stock
is not subject to any repurchase, forfeiture, unfulfilled
vesting or other similar requirements;
(4) to the extent permitted by applicable law and by the
Board, by (i) delivery of a promissory note of the
Participant to the Company on terms determined by the Board, or
(ii) payment of such other lawful consideration as the
Board may determine; or
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(5)
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by any combination of the above permitted forms of payment.
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(g) Substitute Options. In connection
with a merger or consolidation of an entity with the Company or
the acquisition by the Company of property or stock of an
entity, the Board may grant Options in substitution for any
options or other stock or stock-based awards granted by such
entity or an affiliate thereof. Substitute Options may be
granted on such terms as the Board deems appropriate in the
circumstances, notwithstanding any limitations on Options
contained in the other sections of this Section 5 or in
Section 2. Substitute Options shall not count against the
overall share limit set forth in Section 4(a), except as
may be required by reason of Section 422 and related
provisions of the Code.
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6.
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Stock
Appreciation Rights
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(a) General. A Stock Appreciation Right,
or SAR, is an Award entitling the holder, upon exercise, to
receive an amount of Common Stock determined by reference to
appreciation, from and after the date of grant, in the fair
market value of a share of Common Stock. The date as of which
such appreciation or other measure is determined shall be the
exercise date.
(b) Grants. Stock Appreciation Rights may
be granted in tandem with, or independently of, Options granted
under the Plan.
(1) Rules Applicable to Tandem
Awards. When Stock Appreciation Rights are
expressly granted in tandem with Options, (i) the Stock
Appreciation Right will be exercisable only at such time or
times, and to the extent, that the related Option is exercisable
(except to the extent designated by the Board in connection with
a Reorganization Event or a Change in Control Event) and will be
exercisable in accordance with the procedure required for
exercise of the related Option; (ii) the Stock Appreciation
Right will terminate and no longer be exercisable upon the
termination or exercise of the related Option, except to the
extent designated by the Board in connection with a
Reorganization Event or a Change in Control Event and except
that a Stock Appreciation Right granted with respect to less
than the full
C-5
number of shares covered by an Option will not be reduced until
the number of shares as to which the related Option has been
exercised or has terminated exceeds the number of shares not
covered by the Stock Appreciation Right; (iii) the Option
will terminate and no longer be exercisable upon the exercise of
the related Stock Appreciation Right; and (iv) the Stock
Appreciation Right will be transferable only with the related
Option.
(2) Exercise of Independent SARs. A Stock
Appreciation Right not expressly granted in tandem with an
Option will become exercisable at such time or times, and on
such conditions, as the Board may specify in the SAR Award.
(c) Exercise. Stock Appreciation Rights
may be exercised by delivery to the Company of a written notice
of exercise signed by the proper person or by any other form of
notice (including electronic notice) approved by the Board,
together with any other documents required by the Board.
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7.
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Restricted
Stock; Restricted Stock Units
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(a) General. The Board may grant Awards
entitling recipients to acquire shares of Common Stock
(Restricted Stock), subject to the right of the
Company to repurchase all or part of such shares at their issue
price or other stated or formula price (or to require forfeiture
of such shares if issued at no cost) from the recipient in the
event that conditions specified by the Board in the applicable
Award are not satisfied prior to the end of the applicable
restriction period or periods established by the Board for such
Award. Instead of granting Awards for Restricted Stock, the
Board may grant Awards entitling the recipient to receive shares
of Common Stock to be delivered at the time such shares of
Common Stock vest (Restricted Stock Units)
(Restricted Stock and Restricted Stock Units are each referred
to herein as a Restricted Stock Award).
(b) Terms and Conditions. The Board shall
determine the terms and conditions of a Restricted Stock Award,
including the conditions for repurchase (or forfeiture) and the
issue price, if any.
(c) Stock Certificates. Any stock
certificates issued in respect of a Restricted Stock Award shall
be registered in the name of the Participant and, unless
otherwise determined by the Board, deposited by the Participant,
together with a stock power endorsed in blank, with the Company
(or its designee). At the expiration of the applicable
restriction periods, the Company (or such designee) shall
deliver the certificates no longer subject to such restrictions
to the Participant or if the Participant has died, to the
beneficiary designated, in a manner determined by the Board, by
a Participant to receive amounts due or exercise rights of the
Participant in the event of the Participants death (the
Designated Beneficiary). In the absence of an
effective designation by a Participant, Designated
Beneficiary shall mean the Participants estate.
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8.
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Other
Stock-Based Awards
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Other Awards of shares of Common Stock, and other Awards that
are valued in whole or in part by reference to, or are otherwise
based on, shares of Common Stock or other property, may be
granted hereunder to Participants (Other Stock Unit
Awards), including without limitation Awards entitling
recipients to receive shares of Common Stock to be delivered in
the future. Such Other Stock Unit Awards shall also be available
as a form of payment in the settlement of other Awards granted
under the Plan or as payment in lieu of compensation to which a
Participant is otherwise entitled. Other Stock Unit Awards may
be paid in shares of Common Stock or cash, as the Board shall
determine. Subject to the provisions of the Plan, the Board
shall determine the conditions of each Other Stock Unit Award,
including any purchase price applicable thereto.
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9.
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Adjustments
for Changes in Common Stock and Certain Other Events
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(a) Changes in Capitalization. In the
event of any stock split, reverse stock split, stock dividend,
recapitalization, combination of shares, reclassification of
shares, spin-off or other similar change in capitalization or
event, or any distribution to holders of Common Stock other than
an ordinary cash dividend, (i) the number and class of
securities available under this Plan, (ii) the
per-Participant limit set forth in Section 4(b),
(iii) the number and class of securities and exercise price
per share of each outstanding Option, (iv) the share- and
per-share provisions of each Stock Appreciation Right,
(v) the repurchase price per share subject to each
C-6
outstanding Restricted Stock Award, and (vi) the share- and
per-share-related provisions of each outstanding Other Stock
Unit Award, shall be appropriately adjusted by the Company (or
substituted Awards may be made, if applicable) to the extent
determined by the Board.
(b) Reorganization and Change in Control Events
(1) Definitions
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(a)
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A Reorganization Event shall mean:
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(i)
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any merger or consolidation of the Company with or into another
entity as a result of which all of the Common Stock of the
Company is converted into or exchanged for the right to receive
cash, securities or other property or is cancelled;
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(ii) any exchange of all of the Common Stock of the Company
for cash, securities or other property pursuant to a share
exchange transaction; or
(iii) any liquidation or dissolution of the Company.
(b) A Change in Control Event shall mean:
(i) the acquisition by an individual, entity or group
(within the meaning of Section 13(d)(3) or 14(d)(2) of the
Exchange Act) (a Person) of beneficial ownership of
any capital stock of the Company if, after such acquisition,
such Person beneficially owns (within the meaning of
Rule 13d-3
promulgated under the Exchange Act) 50% or more of either
(x) the then-outstanding shares of common stock of the
Company (the Outstanding Company Common Stock) or
(y) the combined voting power of the then-outstanding
securities of the Company entitled to vote generally in the
election of directors (the Outstanding Company Voting
Securities); provided, however, that for purposes of this
subsection (i), the following acquisitions shall not
constitute a Change in Control Event: (A) any acquisition
directly from the Company or (B) any acquisition by any
corporation pursuant to a Business Combination (as defined
below) which complies with clauses (x) and (y) of
subsection (iii) of this definition; or
(ii) such time as the Continuing Directors (as defined
below) do not constitute a majority of the Board (or, if
applicable, the Board of Directors of a successor corporation to
the Company), where the term Continuing Director
means at any date a member of the Board (x) who was a
member of the Board on the date of the initial adoption of this
Plan by the Board or (y) who was nominated or elected
subsequent to such date by at least a majority of the directors
who were Continuing Directors at the time of such nomination or
election or whose election to the Board was recommended or
endorsed by at least a majority of the directors who were
Continuing Directors at the time of such nomination or election;
provided, however, that there shall be excluded from this
clause (y) any individual whose initial assumption of
office occurred as a result of an actual or threatened election
contest with respect to the election or removal of directors or
other actual or threatened solicitation of proxies or consents,
by or on behalf of a person other than the Board; or
(iii) the consummation of a merger, consolidation,
reorganization, recapitalization or share exchange involving the
Company or a sale or other disposition of all or substantially
all of the assets of the Company (a Business
Combination), unless, immediately following such Business
Combination, each of the following two conditions is satisfied:
(x) all or substantially all of the individuals and
entities who were the beneficial owners of the Outstanding
Company Common Stock and Outstanding Company Voting Securities
immediately prior to such Business Combination beneficially own,
directly or indirectly, more than 50% of the then-outstanding
shares of common stock and the combined voting power of the
then-outstanding securities entitled to vote generally in the
election of directors, respectively, of the resulting or
acquiring corporation in such Business Combination (which shall
include, without limitation, a corporation which as a result of
such transaction owns the Company or substantially all of the
Companys assets either directly or through one or more
subsidiaries) (such resulting or acquiring corporation is
referred to herein as the Acquiring Corporation) in
substantially the same proportions as their ownership of the
Outstanding Company
C-7
Common Stock and Outstanding Company Voting Securities,
respectively, immediately prior to such Business Combination and
(y) no Person (excluding any employee benefit plan (or
related trust) maintained or sponsored by the Company or by the
Acquiring Corporation) beneficially owns, directly or
indirectly, 50% or more of the then-outstanding shares of common
stock of the Acquiring Corporation, or of the combined voting
power of the then-outstanding securities of such corporation
entitled to vote generally in the election of directors (except
to the extent that such ownership existed prior to the Business
Combination); or
(iv) the liquidation or dissolution of the Company.
(c) Good Reason shall mean any significant
diminution in the Participants title, authority, or
responsibilities from and after such Reorganization Event or
Change in Control Event, as the case may be, or any reduction in
the annual cash compensation payable to the Participant from and
after such Reorganization Event or Change in Control Event, as
the case may be, or the relocation of the place of business at
which the Participant is principally located to a location that
is greater than 50 miles from its location immediately
prior to such Reorganization Event or Change in Control Event.
(d) Cause shall mean any (i) willful
failure by the Participant, which failure is not cured within
30 days of written notice to the Participant from the
Company, to perform his or her material responsibilities to the
Company or (ii) willful misconduct by the Participant which
affects the business reputation of the Company. The Participant
shall be considered to have been discharged for
Cause if the Company determines, within 30 days
after the Participants resignation, that discharge for
Cause was warranted.
(2) Effect on Options
(a) Reorganization Event. Upon the
occurrence of a Reorganization Event (regardless of whether such
event also constitutes a Change in Control Event), or the
execution by the Company of any agreement with respect to a
Reorganization Event (regardless of whether such event will
result in a Change in Control Event), the Board shall provide
that all outstanding Options shall be assumed, or equivalent
options shall be substituted, by the acquiring or succeeding
corporation (or an affiliate thereof); provided that if such
Reorganization Event also constitutes a Change in Control Event,
except to the extent specifically provided to the contrary in
the instrument evidencing any Option or any other agreement
between a Participant and the Company (A) one-half of the
number of shares subject to the Option which were not already
vested shall be exercisable upon the occurrence of such
Reorganization Event and, subject to (B) below, the
remaining one-half of such number of shares shall continue to
become vested in accordance with the original vesting schedule
set forth in such option, with one-half of the number of shares
that would otherwise have become vested on each subsequent
vesting date in accordance with the original schedule becoming
vested on each subsequent vesting date and (B) such assumed
or substituted options shall become immediately exercisable in
full if, on or prior to the first anniversary of the date of the
consummation of the Reorganization Event, the Participants
employment with the Company or the acquiring or succeeding
corporation is terminated for Good Reason by the Participant or
is terminated without Cause by the Company or the acquiring or
succeeding corporation. For purposes hereof, an Option shall be
considered to be assumed if, following consummation of the
Reorganization Event, the Option confers the right to purchase,
for each share of Common Stock subject to the Option immediately
prior to the consummation of the Reorganization Event, the
consideration (whether cash, securities or other property)
received as a result of the Reorganization Event by holders of
Common Stock for each share of Common Stock held immediately
prior to the consummation of the Reorganization Event (and if
holders were offered a choice of consideration, the type of
consideration chosen by the holders of a majority of the
outstanding shares of Common Stock); provided, however, that if
the consideration received as a result of the Reorganization
Event is not solely common stock of the acquiring or succeeding
corporation (or an affiliate thereof), the Company may, with the
consent of the acquiring or succeeding corporation, provide for
the consideration to be received upon the exercise of Options to
consist solely of common stock of the acquiring or succeeding
corporation (or an affiliate thereof) equivalent in value (as
determined by the Board) to the per share consideration received
by holders of outstanding shares of Common Stock as a result of
the Reorganization Event.
C-8
Notwithstanding the foregoing, if the acquiring or succeeding
corporation (or an affiliate thereof) does not agree to assume,
or substitute for, such Options, or in the event of a
liquidation or dissolution of the Company, the Board shall, upon
written notice to the Participants, provide that all then
unexercised Options will become exercisable in full as of a
specified time prior to the Reorganization Event and will
terminate immediately prior to the consummation of such
Reorganization Event, except to the extent exercised by the
Participants before the consummation of such Reorganization
Event; provided, however, that in the event of a Reorganization
Event under the terms of which holders of Common Stock will
receive upon consummation thereof a cash payment for each share
of Common Stock surrendered pursuant to such Reorganization
Event (the Acquisition Price), then the Board may
instead provide that all outstanding Options shall terminate
upon consummation of such Reorganization Event and that each
Participant shall receive, in exchange therefor, a cash payment
equal to the amount (if any) by which (A) the Acquisition
Price multiplied by the number of shares of Common Stock subject
to such outstanding Options (whether or not then exercisable),
exceeds (B) the aggregate exercise price of such Options.
(b) Change in Control Event that is not a Reorganization
Event. Upon the occurrence of a Change in Control
Event that does not also constitute a Reorganization Event,
except to the extent specifically provided to the contrary in
the instrument evidencing any Option or any other agreement
between a Participant and the Company, the vesting schedule of
such Option shall be accelerated in part so that one-half of the
number of shares that would otherwise have first become vested
on any date after the date of the Change in Control Event shall
immediately become exercisable. The remaining one-half of such
number of shares shall continue to become vested in accordance
with the original vesting schedule set forth in such Option,
with one-half of the number of shares that would otherwise have
become vested on each subsequent vesting date in accordance with
the original schedule becoming vested on each such subsequent
vesting date; provided, however, that each such Option shall be
immediately exercisable in full if, on or prior to the first
anniversary of the date of the consummation of the Change in
Control Event, the Participants employment with the
Company or the acquiring or succeeding corporation is terminated
for Good Reason by the Participant or is terminated without
Cause by the Company or the acquiring or succeeding corporation.
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(3)
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Effect on Restricted Stock Awards
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(a) Reorganization Event that is not a Change in Control
Event. Upon the occurrence of a Reorganization
Event that is not a Change in Control Event, the repurchase and
other rights of the Company under each outstanding Restricted
Stock Award shall inure to the benefit of the Companys
successor and shall apply to the cash, securities or other
property which the Common Stock was converted into or exchanged
for pursuant to such Reorganization Event in the same manner and
to the same extent as they applied to the Common Stock subject
to such Restricted Stock Award.
(b) Change in Control Event. Upon the
occurrence of a Change in Control Event (regardless of whether
such event also constitutes a Reorganization Event), except to
the extent specifically provided to the contrary in the
instrument evidencing any Restricted Stock Award or any other
agreement between a Participant and the Company, the vesting
schedule of all Restricted Stock Awards shall be accelerated in
part so that one-half of the number of shares that would
otherwise have first become free from conditions or restrictions
on any date after the date of the Change in Control Event shall
immediately become free from conditions or restrictions. Subject
to the following sentence, the remaining one- half of such
number of shares shall continue to become free from conditions
or restrictions in accordance with the original schedule set
forth in such Restricted Stock Award, with one-half of the
number of shares that would otherwise have become free from
conditions or restrictions on each subsequent vesting date in
accordance with the original schedule becoming free from
conditions or restrictions on each subsequent vesting date. In
addition, each such Restricted Stock Award shall immediately
become free from all conditions or restrictions if, on or prior
to the first anniversary of the date of the consummation of the
Change in Control Event, the Participants employment with
the Company or the acquiring or succeeding corporation is
terminated for Good Reason by the Participant or is terminated
without Cause by the Company or the acquiring or succeeding
corporation.
C-9
(4) Effect on Stock Appreciation Rights and Other Stock
Unit Awards.
The Board may specify in an Award at the time of the grant the
effect of a Reorganization Event and Change in Control Event on
any SAR and Other Stock Unit Award.
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10.
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General
Provisions Applicable to Awards
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(a) Transferability of Awards. Except as
the Board may otherwise determine or provide in an Award, Awards
shall not be sold, assigned, transferred, pledged or otherwise
encumbered by the person to whom they are granted, either
voluntarily or by operation of law, except by will or the laws
of descent and distribution or, other than in the case of an
Incentive Stock Option, pursuant to a qualified domestic
relations order, and, during the life of the Participant, shall
be exercisable only by the Participant. References to a
Participant, to the extent relevant in the context, shall
include references to authorized transferees.
(b) Documentation. Each Award shall be
evidenced in such form (written, electronic or otherwise) as the
Board shall determine. Each Award may contain terms and
conditions in addition to those set forth in the Plan.
(c) Board Discretion. Except as otherwise
provided by the Plan, each Award may be made alone or in
addition or in relation to any other Award. The terms of each
Award need not be identical, and the Board need not treat
Participants uniformly.
(d) Termination of Status. The Board
shall determine the effect on an Award of the disability, death,
retirement, authorized leave of absence or other change in the
employment or other status of a Participant and the extent to
which, and the period during which, the Participant, or the
Participants legal representative, conservator, guardian
or Designated Beneficiary, may exercise rights under the Award.
(e) Withholding. Each Participant shall
pay to the Company, or make provision satisfactory to the
Company for payment of, any taxes required by law to be withheld
in connection with an Award to such Participant. Except as the
Board may otherwise provide in an Award, for so long as the
Common Stock is registered under the Exchange Act, Participants
may satisfy such tax obligations in whole or in part by delivery
of shares of Common Stock, including shares retained from the
Award creating the tax obligation, valued at their Fair Market
Value; provided, however, except as otherwise provided by the
Board, that the total tax withholding where stock is being used
to satisfy such tax obligations cannot exceed the Companys
minimum statutory withholding obligations (based on minimum
statutory withholding rates for federal and state tax purposes,
including payroll taxes, that are applicable to such
supplemental taxable income). Shares surrendered to satisfy tax
withholding requirements cannot be subject to any repurchase,
forfeiture, unfulfilled vesting or other similar requirements.
The Company may, to the extent permitted by law, deduct any such
tax obligations from any payment of any kind otherwise due to a
Participant.
(f) Amendment of Award. The Board may
amend, modify or terminate any outstanding Award, including but
not limited to, substituting therefor another Award of the same
or a different type, changing the date of exercise or
realization, and converting an Incentive Stock Option to a
Nonstatutory Stock Option, provided that the Participants
consent to such action shall be required unless the Board
determines that the action, taking into account any related
action, would not materially and adversely affect the
Participant.
(g) Conditions on Delivery of Stock. The
Company will not be obligated to deliver any shares of Common
Stock pursuant to the Plan or to remove restrictions from shares
previously delivered under the Plan until (i) all
conditions of the Award have been met or removed to the
satisfaction of the Company, (ii) in the opinion of the
Companys counsel, all other legal matters in connection
with the issuance and delivery of such shares have been
satisfied, including any applicable securities laws and any
applicable stock exchange or stock market rules and regulations,
and (iii) the Participant has executed and delivered to the
Company such representations or agreements as the Company may
consider appropriate to satisfy the requirements of any
applicable laws, rules or regulations.
C-10
(h) Acceleration. The Board may at any
time provide that any Award shall become immediately exercisable
in full or in part, free of some or all restrictions or
conditions, or otherwise realizable in full or in part, as the
case may be.
(a) No Right To Employment or Other
Status. No person shall have any claim or right
to be granted an Award, and the grant of an Award shall not be
construed as giving a Participant the right to continued
employment or any other relationship with the Company. The
Company expressly reserves the right at any time to dismiss or
otherwise terminate its relationship with a Participant free
from any liability or claim under the Plan, except as expressly
provided in the applicable Award.
(b) No Rights As Stockholder. Subject to
the provisions of the applicable Award, no Participant or
Designated Beneficiary shall have any rights as a stockholder
with respect to any shares of Common Stock to be distributed
with respect to an Award until becoming the record holder of
such shares. Notwithstanding the foregoing, in the event the
Company effects a split of the Common Stock by means of a stock
dividend and the exercise price of and the number of shares
subject to such Option are adjusted as of the date of the
distribution of the dividend (rather than as of the record date
for such dividend), then an optionee who exercises an Option
between the record date and the distribution date for such stock
dividend shall be entitled to receive, on the distribution date,
the stock dividend with respect to the shares of Common Stock
acquired upon such Option exercise, notwithstanding the fact
that such shares were not outstanding as of the close of
business on the record date for such stock dividend.
(c) Effective Date and Term of Plan. The
Plan shall become effective on the date on which it is adopted
by the Board. No Awards shall be granted under the Plan after
the completion of 10 years from the earlier of (i) the
date on which the Plan was adopted by the Board or (ii) the
date the Plan was approved by the Companys stockholders,
but Awards previously granted may extend beyond that date.
(d) Amendment of Plan. The Board may
amend, suspend or terminate the Plan or any portion thereof at
any time; provided that, to the extent determined by the Board,
no amendment requiring stockholder approval under any applicable
legal, regulatory or listing requirement shall become effective
until such stockholder approval is obtained.
(e) Authorization of Sub-Plans. The Board
may from time to time establish one or more sub-plans under the
Plan for purposes of satisfying applicable blue sky, securities
or tax laws of various jurisdictions. The Board shall establish
such sub-plans by adopting supplements to this Plan containing
(i) such limitations on the Boards discretion under
the Plan as the Board deems necessary or desirable or
(ii) such additional terms and conditions not otherwise
inconsistent with the Plan as the Board shall deem necessary or
desirable. All supplements adopted by the Board shall be deemed
to be part of the Plan, but each supplement shall apply only to
Participants within the affected jurisdiction and the Company
shall not be required to provide copies of any supplement to
Participants in any jurisdiction which is not the subject of
such supplement.
(f) Compliance with Code
Section 409A. No Award shall provide for
deferral of compensation that does not comply with
Section 409A of the Code, unless the Board, at the time of
grant, specifically provides that the Award is not intended to
comply with Section 409A of the Code.
(g) Governing Law. The provisions of the
Plan and all Awards made hereunder shall be governed by and
interpreted in accordance with the laws of the State of
Delaware, excluding choice-of-law principles of the law of such
state that would require the application of the laws of a
jurisdiction other than such state.
Adopted by the Board of Directors on September 7, 2005
Approved by the stockholders on October 14, 2005
C-11
ANNEX
D
THIS
PROXY IS SOLICITED ON BEHALF OF THE BOARD OF DIRECTORS
NXSTAGE
MEDICAL, INC.
SPECIAL
MEETING OF STOCKHOLDERS
,
2007
Those signing on the reverse side, revoking any prior proxies,
hereby appoint(s) Robert S. Brown and Winifred L. Swan, or each
of them, with full power of substitution, as proxies for those
signing on the reverse side to act and vote at the Special
Meeting of Stockholders of NxStage Medical, Inc. and at any
adjournments thereof as indicated upon all matters referred to
on the reverse side and described in the proxy statement for the
special meeting, and, in their discretion, upon any other
matters which may properly come before the special meeting.
THIS PROXY, WHEN PROPERLY EXECUTED, WILL BE VOTED AS DIRECTED
BY THE UNDERSIGNED STOCKHOLDER.
Please sign this proxy exactly as your name appears hereon.
Joint owners should each sign personally. Trustees and other
fiduciaries should indicate the capacity in which they sign. If
a corporation or partnership, this signature should be that of
an authorized officer who should state his or her title.
UNLESS
YOU INTEND TO VOTE YOUR SHARES BY INTERNET OR
TELEPHONE, PLEASE MARK, SIGN, DATE, AND RETURN THIS PROXY
CARD
PROMPTLY IN ENCLOSED REPLY ENVELOPE
ADDRESS CHANGES/COMMENTS?
(If you noted any address changes/comments above, please mark
corresponding box on other side)
CONTINUED AND TO BE SIGNED ON REVERSE SIDE
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NXSTAGE
439 SOUTH UNION ST., 5th FLR
LAWRENCE, MA 01843
ATTN:
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VOTE BY INTERNET
www.investorvote.com. Use the Internet to transmit your
voting instructions and for electronic delivery of information
up until 11:59 p.m. Eastern Time the day before the
cut-off date or meeting date. Have your proxy card in hand when
you access the website and follow the instructions to obtain
your records and to create an electronic voting instruction form
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VOTE BY PHONE
1-800-652-VOTE
(8683)
Use any touch-tone telephone to transmit your voting
instructions up until 11:59 p.m. Eastern Time the day
before the cut-off date or meeting date. Have your proxy card in
hand when you call and then follow the instructions
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VOTE BY MAIL
Mark, sign and date your proxy card and return it in the
postage-paid envelope we have provided or return it to NxStage
Medical, Inc.,
c/o Computershare
Investor Services, PO Box 43010, Providence, RI
02940-3010
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TO VOTE, MARK BLOCKS IN BLUE OR
BLACK INK AS FOLLOWS
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KEEP
THIS PORTION FOR YOUR RECORDS
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DETACH AND RETURN THIS PORTION ONLY
THIS PROXY CARD IS VALID ONLY WHEN SIGNED AND DATED.
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FOR
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AGAINST
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ABSTAIN
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1.
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To approve the issuance of
6,500,000 shares of our common stock, plus any additional
shares of common stock issuable pursuant to a post-closing
working capital adjustment, pursuant to the stock purchase
agreement, and any additional shares of our common stock that we
may be required to issue in the future to satisfy any
indemnification obligations under the stock purchase agreement
or consulting agreement.
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FOR
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AGAINST
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ABSTAIN
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2.
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To amend our 2005 Stock Incentive
Plan to increase the number of shares of our common stock which
may be issued pursuant to the plan by an additional
3,800,000 shares, of which no more than
1,500,000 shares shall be granted as restricted stock,
restricted stock units and other stock-based awards.
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3.
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To transact such other business as
may properly come before the meeting or any adjournment thereof.
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For address changes/comments, please check this box and write
them on the back where
indicated o
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Signature:
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Date:
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Signature:
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Date:
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D-2