Filed
Pursuant to Rule 424(b)(3)
Registration
Statement No. 333-128069
PROSPECTUS
RITA
MEDICAL SYSTEMS, INC.
2,406,947
Shares of Common Stock
This
prospectus relates to the resale of up to 2,406,947 shares of our common
stock,
par value $0.001 per share, issuable upon conversion of subordinated senior
convertible notes held by the selling securityholder identified on page 10
of
this prospectus. See “Plan of Distribution” on page 11 of this prospectus for a
description of the manner in which shares of common stock may be offered
and
sold by the selling securityholder under this prospectus. The selling
securityholder may be deemed to be an “underwriter,” as such term is defined in
the Securities Act of 1933.
The
selling securityholder identified on page 10 of this prospectus may offer
and
sell the shares of common stock covered by this prospectus from time to time.
We
will not receive any of the proceeds from the sale of the shares by the selling
securityholder. The selling securityholder will receive all of the proceeds
from
the sale of the shares and will pay all underwriting discounts and selling
commissions, if any, applicable to the sale of the shares. We will pay the
expenses of registration of the sale of the shares.
Our
common stock trades on the Nasdaq National Market under the symbol “RITA”. On
September 12, 2005, the last reported sale price of our common stock on the
Nasdaq National Market was $3.79 per share.
Beginning
on page 3 of this prospectus, we have listed several “RISK FACTORS” which you
should consider. You should read the entire prospectus carefully before you
make
your investment decision.
___________________
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or passed upon the accuracy or
adequacy of this prospectus. Any representation to the contrary is a criminal
offense.
___________________
The
date
of this prospectus is September 13, 2005.
TABLE
OF CONTENTS
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Page
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ABOUT
THIS PROSPECTUS
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i
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CAUTIONARY
STATEMENT REGARDING FORWARDING LOOKING STATEMENTS
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1
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THE
COMPANY
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2
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RISK
FACTORS
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3
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USE
OF PROCEEDS
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9
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TRANSACTIONS
WITH SELLING SECURITYHOLDER
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9
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SELLING
SECURITYHOLDER
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10
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PLAN
OF DISTRIBUTION
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11
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LEGAL
MATTERS
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12
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EXPERTS
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12
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WHERE
YOU CAN FIND MORE INFORMATION
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12
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INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
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13
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This
prospectus is part of a registration statement that we filed with the Securities
and Exchange Commission, or SEC, using a “shelf” registration or continuous
offering process. Under this shelf registration process, the selling
securityholder may from time to time sell the securities described in this
prospectus in one or more offerings.
This
prospectus provides you with a general description of the securities that
the
selling securityholder may offer. The selling securityholder may be required
to
provide you with a prospectus supplement containing specific information
about
the selling securityholder and the terms of the securities being offered.
That
prospectus supplement may include additional risk factors or other special
considerations applicable to those securities. A prospectus supplement may
also
add, update or change information in this prospectus. If there is any
inconsistency between the information in this prospectus and any prospectus
supplement, you should rely on the information in that prospectus supplement.
You should read both this prospectus and any prospectus supplement together
with
the additional information described under the heading “Where You Can Find More
Information.”
Unless
we
have indicated otherwise, references in this prospectus to “RITA,”“we,”“us” and
“our” or similar terms are to RITA Medical Systems, Inc. and its consolidated
subsidiaries, and references to “Horizon” are to Horizon Medical Products, Inc.
CAUTIONARY
STATEMENT CONCERNING
FORWARD-LOOKING
STATEMENTS
This
prospectus and the other documents incorporated by reference into this
prospectus contain forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Statements in this prospectus and
the
other documents incorporated into this prospectus by reference that are not
historical facts are identified as “forward-looking statements” for the purpose
of the safe harbor provided by Section 21E of the Securities Exchange Act
of
1934, as amended, or the Exchange Act, and Section 27A of the Securities
Act of
1933, as amended, or the Securities Act. Forward-looking statements include
projections, assumptions or information concerning possible or assumed future
actions, events or our results of operations. These statements involve estimates
and assumptions based on the judgment of the company’s management. A number of
risks and uncertainties may cause actual results to differ materially from
those
suggested by the forward-looking statements.
Forward-looking
statements include the information in this prospectus and the other documents
incorporated by reference into this prospectus. These statements may be made
regarding the business, operations, financial performance and condition,
earnings, our prospects and products, as well as regarding our industry
generally. These statements may be preceded by, followed by or include the
words
“believes,”“expects,”“anticipates,”“intends,”“plans,”“estimates,”“should” or
similar expressions. We claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities Litigation
Reform
Act of 1995 for all forward-looking statements. We do not undertake any
obligation to publicly update any forward-looking statements to reflect
subsequent events or circumstances.
Forward-looking
statements are not guarantees of performance. You should understand that
these
factors, in addition to those discussed in “Risk Factors” above and elsewhere in
this document, and in the documents that are incorporated by reference into
this
prospectus, could affect our future results and could cause those results
or
other outcomes to differ materially from those expressed or implied in any
forward-looking statement.
THE
COMPANY
We
develop, manufacture and market innovative products for cancer patients
including radiofrequency ablation, or RFA, systems for treating cancerous
tumors
as well as percutaneous vascular and spinal access systems. Our oncology
product
lines include implantable ports, some of which feature our proprietary VTX(R)
technology; tunneled central venous catheters; and stem-cell transplant
catheters used primarily in cancer treatment protocols. The proprietary RITA
system uses radio frequency energy to heat tissue to a high enough temperature
to ablate it or cause cell death. In March 2000, we became the first RFA
company
to receive specific U.S. Food and Drug Administration, or FDA, clearance
for
unresectable liver lesions in addition to our previous general FDA clearance
for
the ablation of soft tissue. In October 2002, we again became the first company
to receive specific FDA clearance, this time, for the palliation of pain
associated with metastatic lesions involving bone.
We
are a
Delaware corporation and are headquartered in Fremont, California with
operations in Fremont, California, Manchester, Georgia and Atlanta, Georgia.
Our
principal executive offices are located at 46421 Landing Parkway, Fremont,
California 94538, and our telephone number is (510) 771-0400. Our internet
website is www.ritamedical.com. Information set forth on our website is not
incorporated by reference into this prospectus.
RISK
FACTORS
In
addition to the other information included in this prospectus, including
the
matters addressed in “Cautionary Statement Concerning Forward-Looking
Statements,” you should consider carefully the following risks related to our
common stock before deciding to invest in our shares of common stock. These
factors, among others, may cause actual results, events or performance to
differ
materially from those expressed in any forward-looking statements we make
in
this prospectus.
We
have limited experience manufacturing our RFA and SAC disposable devices
in
substantial quantities, and if we are unable to hire sufficient additional
personnel or to purchase additional equipment or are otherwise unable to
meet
customer demand, our business could suffer. Also, we have consolidated our
manufacturing operations at our Manchester, Georgia location, and, prior
to
September 30, 2004, personnel at that location had essentially no
experience in manufacturing our radiofrequency ablation disposable devices.
To
be
successful, we must manufacture our products in substantial quantities in
compliance with regulatory requirements at acceptable costs. If we do not
succeed in manufacturing quantities of our disposable devices that meet customer
demand, we could lose customers and our business could suffer. At the present
time, we have limited high-volume manufacturing experience. Our manufacturing
operations are currently focused on the in-house assembly of our disposable
devices. As we increase our manufacturing volume and the number of product
designs for our disposable devices, the complexity of our manufacturing
processes will increase. Because our manufacturing operations are primarily
dependent upon manual assembly, if demand for our system increases we will
need
to hire additional personnel and may need to purchase additional equipment.
If
we are unable to sufficiently staff and equip our manufacturing operations,
or
are otherwise unable to meet customer demand for our products, our business
could suffer.
If
we become unable to meet customer demand through disruption of manufacturing
operations, our business could suffer.
We
have
transitioned our California-based manufacturing operations to our Manchester,
Georgia location. We have incurred low product yields in our initial production
runs of RFA products in Georgia. If we become unable to meet customer demand
for
our products, or if the high initial costs associated with manufacture of
our
RFA products in Georgia do not abate, our business could suffer.
We
have identified material weaknesses in our internal control over financial
reporting. Failure to remediate these weaknesses could impact the reliability
of
our financial reporting.
To
date,
we have identified material weaknesses in our procurement process which did,
prior to adjustment, or could otherwise, result in a material misstatement
of
our annual or interim financial statements. As a result of these material
weaknesses, we have determined that we did not maintain effective internal
control over financial reporting as of December 31, 2004. See our disclosure
in
“Status of Management’s Report on Internal Control over Financial Reporting”
included in our annual report on Form 10-K, as amended, for the year ended
December 31, 2004 for further discussion of these material weaknesses.
We
may be unable to realize all of the anticipated benefits of our merger with
Horizon Medical Products.
Our
merger with Horizon involved the integration of two companies that previously
have operated independently, a complex, costly and time-consuming process.
The
difficulties of combining the companies’ operations have included, among other
things:
• coordinating
geographically disparate organizations, systems and facilities;
• integrating
personnel with diverse business backgrounds;
• consolidating
corporate and administrative functions;
• consolidating
research and development, and manufacturing operations;
• coordinating
sales and marketing functions;
• retaining
key employees; and
• preserving
research and development, collaboration, distribution, marketing, promotion
and
other important relationships of the companies.
We
believe that the integration of the two companies was essentially complete
as of
June 30, 2005. However, as of June 30, 2005, we have less than a full year
of
combined operations, and we may, in the future, encounter again any or all
of
the difficulties in operational integration we have faced in the period since
the merger. These difficulties could include an interruption of, or loss
of
momentum in, the activities of the combined company’s business and the loss of
key personnel. Further, the diversion of our management’s attention and any
delays or difficulties encountered in connection with the operation of our
geographically disparate organization could harm our business, results of
operations, financial condition or prospects.
We
will be heavily dependent on the RITA system and our line of specialty access
catheters in order to achieve our sales goals and our profitability targets.
Failure to achieve and grow market acceptance for either product line could
harm
our business.
The
majority of our sales will come from the sale of the RITA system and our
line of
specialty access catheters. Our financial performance will depend upon physician
adoption and patient awareness of these products. If we are unable to convince
physicians to use these products, we may not be able to generate sales because
we do not have alternative products.
We
have a history of losses and may never achieve profitability.
We
incurred net losses of $3.1 million during the first six months of 2005,
$9.3
million in 2004, $11.1 million in 2003, $13.5 million in 2002, $13.0 million
in
2001, $12.8 million in 2000 and $7.5 million in 1999. At June 30, 2005, we
had
an accumulated deficit of $91.4 million. To become profitable we must increase
our sales and continue to limit the growth of our operating expenses. If
our
sales do not grow, or if expenses grow excessively, we may not be able to
achieve or maintain profitability in the future.
Because
we face significant competition from companies with greater resources than
we
have, we may be unable to compete effectively.
The
market for our products is intensely competitive, subject to rapid change
and
significantly affected by new product introductions and other market activities
of industry participants.
In
the
market for radiofrequency ablation products, we compete directly with two
companies both domestically and internationally: RadioTherapeutics Corporation,
a division of Boston Scientific, and Radionics, Inc., a division of Tyco
Healthcare, which is a division of Tyco International. Boston Scientific
and
Tyco International are publicly traded companies with substantially greater
resources than we have. Both RadioTherapeutics and Radionics sell products
that
use radiofrequency energy to ablate soft tissue. Furthermore, in April 2003,
we
entered into a license agreement with Boston Scientific, its affiliates and
licensors, pursuant to which we granted Boston Scientific rights to manufacture
and sell products using our infusion technology after October 5, 2004. As
a
result, Boston Scientific may develop and sell some competing products that
would, in the absence of this license agreement, infringe our patents.
In
the
market for specialty access catheters and ports, we compete directly with
C.R.
Bard Inc. C.R. Bard is a publicly traded company with substantially greater
resources than we have.
We
are
also aware of several companies in international markets that sell products
that
compete directly with ours. These companies are affecting our international
market share and may erode that share in the future. In addition, one of
these
companies, Berchtold Corporation, has received FDA clearance for using
radiofrequency energy to ablate soft tissue.
Alternative
therapies could prove to be superior to our radiofrequency ablation system
or
our implantable specialty access products, and physician adoption of our
products could be negatively affected.
In
addition to competing against other companies offering products that use
radiofrequency energy to ablate soft tissue or implantable vascular products,
we
also compete against companies developing, manufacturing and marketing
alternative therapies that address solid cancerous and benign tumors. If
these
alternative therapies prove to offer treatment options that are perceived
to be
superior to our products or to have less severe side effects than those
resulting from our products, physician adoption of our products could be
negatively affected and our sales could decline.
We
currently lack long-term data regarding the safety and efficacy of our
radiofrequency ablation products and may find that long-term data does not
support our short-term clinical results or that further short or long-term
studies do not support the safety and efficacy of our radiofrequency ablation
products in various applications. If the safety or efficacy of our
radiofrequency ablation products is questioned, our sales could decline.
Our
radiofrequency ablation products are supported by clinical follow-up data
in
published clinical reports or scientific presentations covering periods from
five months to five years after radiofrequency ablation. If additional studies
in liver cancer or in other applications fail to confirm or demonstrate the
effectiveness of our radiofrequency ablation products, our sales could decline.
If longer-term patient follow-up or clinical studies indicate that our
procedures cause unexpected, serious complications or other unforeseen negative
effects, we could be subject to significant liability. Further, because some
of
our data has been produced in studies that were retrospective, not randomized,
or included small patient populations and because, in certain circumstances,
we
rely on clinical data developed by independent third party physicians, our
clinical data may not be reproduced in wider patient populations.
If
we are unable to protect our intellectual property rights or if we are found
to
infringe the rights of others, we may lose market share to our competitors
and
our business could suffer.
Our
success depends significantly on our ability to protect our proprietary rights
to the technologies used in our products, and yet we may be unable to do
so. A
number of companies in our market, as well as universities and research
institutions, have issued patents and have filed patent applications that
relate
to the use of radiofrequency energy to ablate soft tissue or to the design
or
manufacture of implantable vascular products. Under certain circumstances
these
patent applications could result in lawsuits against us. Our pending United
States and foreign patent applications may not issue or may issue and be
subsequently successfully challenged by others. In addition, our pending
patent
applications include claims to material aspects of our products that are
not
currently protected by issued patents. Both the patent application process
and
the process of managing patent disputes can be time consuming and expensive.
In
the
event a competitor infringes on our patent or other intellectual property
rights, enforcing those rights may be difficult and time consuming. Even
if
successful, litigation to enforce our intellectual property rights or to
defend
our patents against challenge could be expensive and time consuming and could
divert management’s attention. We may not have sufficient resources to enforce
our intellectual property rights or to defend our patents against a challenge.
In addition, confidentiality agreements executed by our employees, consultants
and advisors may not be enforceable or may not provide meaningful protection
for
our trade secrets or other proprietary information in the event of unauthorized
use or disclosure. If we are unable to protect our intellectual property
rights,
we could lose market share to our competitors and our business could suffer.
Our
dependence on international revenues, which account for a significant portion
of
our total revenues, could harm our business.
Because
our future profitability will depend in part on our ability to increase product
sales in international markets, we are exposed to risks specific to business
operations outside the United States. These risks include:
• the
challenge of managing international sales without direct access to the end
customer;
• lower
average selling prices for our products, due to distributor discounts;
• the
risk
of inventory build-up by our distributors which could negatively impact sales
in
future periods;
• obtaining
reimbursement for procedures using our devices in some foreign markets;
• the
burden of complying with complex and changing foreign regulatory requirements;
• longer
accounts receivable collection time;
• significant
currency fluctuations, which could cause our distributors to reduce the number
of products they purchase from us because the cost of our products to them
could
increase relative to the price they could charge their customers;
• reduced
protection of intellectual property rights in some foreign countries; and
• contractual
provisions governed by foreign laws.
We
are substantially dependent on our Italian distributor and if we lose this
distributor, or if this distributor significantly reduces its product demand,
our international and total sales could decline.
We
are
substantially dependent on M.D.H. s.r.l. Forniture Ospedaliere, our distributor
in Italy, which accounted for 18% of our international sales in the first
six
months of 2005 and 19% of our international sales for the year ended December
31, 2004. International sales accounted for 16% of our total sales in the
first
six months of 2005 and 16% of our total sales for the year ended December
31,
2004. The loss of this distributor, or a significant decrease in demand from
this distributor, could cause our sales to decline substantially.
Our
relationships with third-party distributors could negatively affect our sales.
We
sell
our products in international markets and selected domestic markets through
third-party distributors over whom we have limited control, and, if they
fail to
adequately support our products, our sales could decline. In the past, we
have
terminated agreements with distributors and although we contracted with
replacement distributors, we expended significant time and resources in doing
so, and our sales in the affected markets suffered during the transition
period
that lasted approximately nine months. If our distributors or we terminate
other
distributor agreements, we could incur similar or more burdensome expenses,
we
could expend significant time and resources in finding replacement distributors
or in establishing a direct sales force, and our sales could decrease during
any
related transition period.
We
are
aware that some of our distributors have, in the past, built up inventory
of our
products. As a result, future sales to these distributors could be negatively
impacted. Sales to our Japanese distributor in 2004 and 2003 and to a domestic
distributor in the three months ended September 30, 2004 were so affected.
In
addition, while our distributors have no price protection and may only return
undamaged products per our return policies, if we permit the return of products
in excess of our provision for returns, we will have to adjust our revenues
relating to these products. This may also impact our revenue recognition
policy
on future distributor sales.
In
2002,
we significantly increased our allowance for doubtful accounts to address
the
risk associated with longer collection periods that have arisen principally
with
our European distributors. Although the deterioration we experienced in
international collections in 2002 stabilized in 2003, and has remained stable
in
2004 and 2005, we may encounter new difficulties with collections that require
further increases in our allowance for doubtful accounts in the future, and
we
may require specific accounts to post letters of credit or pay in advance
to
minimize our credit risk. Further, we may, in the future, terminate
relationships with some of our distributors, making collection of accounts
receivable with these customers difficult. We believe our allowance for doubtful
accounts sufficiently reflects this possibility, but additional provisions
to
the allowance for doubtful accounts are could be required. Additional future
increases in our allowance for doubtful accounts would reduce our
profits.
If
customers in markets outside the United States experience difficulty obtaining
reimbursement for procedures using our products, international sales could
decline.
Certain
of the markets outside the United States in which we sell our products require
that specific reimbursement codes be obtained before reimbursement for
procedures using our products can be approved. As a result, in countries
where
specific reimbursement codes are strictly required and have not yet been
issued,
reimbursement has been denied on that basis. If our distributors or we are
unable to either obtain the required reimbursement codes or develop an effective
strategy to resolve the reimbursement issue, physicians in foreign markets
may
be unwilling to purchase our products, negatively impacting our international
revenues.
Our
business is dependent upon reimbursement from government programs, such as
Medicare and Medicaid, and we may face limitations on such third-party
reimbursement, which could harm our operating results.
In
the
United States, our products are purchased primarily by hospitals and medical
clinics, which then bill various third-party payors, such as Medicare, Medicaid
and other government programs and private insurance plans, for the healthcare
services provided to patients. Government agencies, private insurers and
other
payors determine whether to provide coverage for a particular procedure and
reimburse hospitals for medical treatment at a fixed rate based on the
diagnosis-related group, or DRG, established by the United States Centers
for
Medicare and Medicaid Services, or CMS. The fixed rate of reimbursement is
based
on the procedure performed and is unrelated to the specific devices used
in that
procedure. If a procedure is not covered by a DRG, payors may deny
reimbursement. In addition, third-party payors may deny reimbursement if
they
determine that the device used in a treatment was unnecessary, inappropriate
or
not cost-effective, experimental or used for a non-approved indication.
There
can
be no assurance that reimbursement for the use of our products will continue
at
current levels, or that future reimbursement policies of third-party payors
will
not adversely affect our ability to sell our products on a profitable basis.
Failure by hospitals and other users of our products to obtain reimbursement
from third-party payors, or changes in government and private third-party
payors’ policies toward reimbursement for procedures employing our products,
would have a material adverse effect on our business, results of operations
and
financial condition.
We
depend on key employees in a competitive market for skilled personnel and
without additional employees we cannot grow or achieve profitability.
We
are
highly dependent on the principal members of our management team, including
our
Chief Executive Officer as well as key staff in the areas of finance, operations
and research and development. During our second quarter ended June 30, 2005,
our
Chief Financial Officer announced his resignation effective as of October
2005,
and a search is being conducted for a replacement. Our future success will
depend in part on the continued service of our staff and our ability to
identify, hire and retain additional personnel. The markets for qualified
management personnel in Northern California, where our headquarters are located,
and Georgia, where are primary operating facilities are located, are competitive
and expected to remain so. Because the environment for qualified personnel
is
so
competitive, costs related to compensation may increase significantly. If
we are
unable to attract and retain both the management team and key personnel we
need
to support and grow our business, our business will suffer.
We
are subject to, and may in the future be subject to, costly and time-consuming
product liability actions.
We
manufacture medical devices that are used on patients in both minimally invasive
and open surgical procedures and, as a result, we are and may in the future
be
subject to product liability lawsuits. 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 coverage in the future.
In
addition, we could have to pay any amount awarded by a court in excess of
policy
limits. Finally, even a meritless or unsuccessful product liability claim
could
be time consuming and expensive to defend and could result in the diversion
of
management’s attention from managing our core business.
Any
failure in our physician training efforts could result in lower than expected
product sales.
It
is
critical to our sales effort to train a sufficient number of physicians and
to
instruct them properly in the procedures that utilize our products. We have
established formal physician training programs and rely on physicians to
devote
adequate time to understanding how and when our products should be used.
If
physicians are not properly trained, they may misuse or ineffectively use
our
products. Such use may result in unsatisfactory patient outcomes, patient
injury
and related liability or negative publicity that could have an adverse effect
on
our product sales.
We
may incur significant costs related to a class action lawsuit due to the
likely
volatility of our stock.
Our
stock
price is likely to fluctuate owing to market uncertainty about our ability
to
successfully integrate the operations of Horizon and manage our cash. Our
stock
price may also fluctuate for a number of other reasons including:
• our
ability to repay debt;
• our
ability to successfully commercialize our products;
• our
ability to comply with Section 404 of the Sarbanes-Oxley Act of 2002;
• conclusions
that our internal control over financial reporting are ineffective;
• announcements
regarding patent litigation or the issuance of patents to us or our competitors;
• quarterly
fluctuations in our results of operations;
• announcements
of technological or competitive developments by us or our competitors;
• product
liability claims;
• regulatory
developments regarding us or our competitors;
• acquisitions
or strategic alliances by us or our competitors;
• changes
in estimates of our financial performance or changes in recommendations by
securities analysts; and
• general
market conditions, particularly for companies with small market capitalizations.
Securities
class action litigation is often brought against a company after a period
of
volatility in the market price of its stock. If our future quarterly operating
results are below the expectations of securities analysts or investors, the
price of our common stock would likely decline. Stock price fluctuations
may be
exaggerated if the trading volume of our common stock is low. Any securities
litigation claims brought against us could result in substantial expense
and
divert management’s attention from our core business.
We
are dependent on two suppliers as the only sources of a component that we
use in
our radiofrequency ablation disposable devices, and any disruption in the
supply
of this component could negatively affect our business.
Until
2003, there was only one supplier available to provide us with a component
that
we include in our disposable devices. During the quarter ended September
30,
2003, we qualified a second supplier. However, a disruption in the supply
of
this component is still possible and could negatively affect revenues. If
we
were unable to remedy a disruption in supply of this component within twelve
months, we could be required to redesign the handle of our RFA disposable
devices, which could divert engineering resources from other projects or
add to
product costs. In addition, a new or supplemental filing with applicable
regulatory authorities may require clearance prior to our marketing a product
containing new materials. This clearance process may take a substantial period
of time, and we may be unable to obtain necessary regulatory approvals for
any
new material to be used in our products on a timely basis, if at all.
We
are dependent on one supplier as our only source of an accessory device used
in
conjunction with our Starburst XLi and Xlie lines of disposable devices,
and any
disruption in the supply of this device could negatively affect our sales.
In
the
past, we have experienced shortages in the supply of accessory infusion pumps
used in conjunction with our Starburst Xli and Starburst Xlie lines of
disposable radiofrequency devices. We currently have one supplier for our
accessory infusion pumps and, although we believe this supplier to be reliable,
future disruptions in supply are possible. In that event, our business could
suffer due to lower sales or higher costs.
We
are dependent on two third-party contractors for the supply of our generators,
and any failure to deliver generators to us could result in lower than expected
sales.
We
are
dependent on two third-party suppliers to produce our RFA generators. While
we
have agreements with both of these suppliers, any delay in shipments of
generators to us could result in our failure to ship generators to customers
and
could negatively affect sales.
Complying
with the FDA and other domestic and foreign regulatory authorities is an
expensive and time-consuming process, and any failure to comply could result
in
substantial penalties.
We
are
subject to a host of federal, state, local and foreign regulations regarding
the
manufacture and marketing of our products. In particular, our failure to
comply
with FDA regulations could result in, among other things, seizures or recalls
of
our products, an injunction, substantial fines and/or criminal charges against
our employees and us. The FDA’s medical device reporting regulations require us
to report any incident in which our products may have caused or contributed
to a
death or serious injury, or in which our products malfunctioned in a way
that
would be likely to cause or contribute to a death or serious injury if the
malfunction recurred.
Sales
of
our products outside the United States are subject to foreign regulatory
requirements that vary from country to country. The time required to obtain
approvals from foreign countries may be longer than that required for FDA
approval or clearance, and requirements for foreign licensing may differ
from
FDA requirements. For example, some of our newer RFA products have not received
approval in Japan. Any failure to obtain necessary regulatory approvals for
our
new products in foreign countries could negatively affect revenues.
Product
introductions or modifications may be delayed or canceled as a result of
the FDA
regulatory process, which could cause our revenues to be below expectations.
Unless
we
are exempt, we must obtain the appropriate FDA approval or clearance before
we
can sell a new medical device in the United States. Obtaining this approval
or
clearance can be a lengthy and time-consuming process. To date, all of our
products have received clearances from the FDA through premarket notification
under Section 510(k) of the Federal Food, Drug and Cosmetic Act. However,
if the
FDA requires us to submit a new premarket notification under Section 510(k)
for
modifications to our existing products, or if the FDA requires us to go through
a lengthier, more rigorous examination than we now expect, our product
introductions or modifications could be delayed or canceled which could cause
our revenues to be below expectations. The FDA may determine that future
products will require the more costly, lengthy and uncertain premarket approval
process.
In
addition, modifications to medical device products cleared via the 510(k)
process may require a new 510(k) submission. We have, in the past, made minor
modifications to the RITA system and to our implantable vascular products.
Using
the guidelines established by the FDA, we have determined that some of these
modifications do not require us to file new 510(k) submissions. If the FDA
disagrees with our determinations, we may not be able to sell the RITA system
or
our implantable vascular products until the FDA has cleared new 510(k)
submissions for these modifications, or it may require us to recall previously
sold products. In addition, we intend to request additional label indications,
such as approvals or clearances for the ablation of tumors in additional
organs,
including lung, uterus and breast, for our current products. The FDA may
either
deny these requests outright, require additional extensive clinical data
to
support any additional indications or impose limitations on the intended
use of
any cleared product as a condition of approval or clearance. Therefore,
obtaining necessary approvals or clearances for these additional applications
could be an expensive and lengthy process. In addition, in the course of
the FDA
process leading to clearance or approval for a new indication, the FDA may
request an advisory panel meeting or meetings to discuss the clinical data,
the
appropriate study design or other criteria for clearance or approval. In
the
event that the advisory panel advises FDA that the clinical data are inadequate
or the study design or other criteria are inappropriate, and the FDA concurs,
the FDA clearance or approval process could be lengthened and anticipated
revenues from that new indication would be delayed.
We
may acquire technologies or companies in the future, which could result in
the
dilution of our stockholders and disruption of our business, and reduce our
revenues.
We
are
continually evaluating business alliances and external investments in
technologies related to our business. Acquisitions of companies, divisions
of
companies, businesses or products entail numerous risks, any of which could
materially harm our business in several ways, including:
• diversion
of management’s attention from our core business objectives and other business
concerns;
• failure
to integrate efficiently businesses or technologies acquired in the future
with
our pre-existing business or technologies;
• potential
loss of key employees from either our pre-existing business or the acquired
business;
• dilution
of our existing stockholders as a result of issuing equity securities; and
• assumption
of liabilities of the acquired company.
Some
or
all of these problems may result from future acquisitions or investments.
Furthermore, we may not realize any value from such acquisitions or investments.
We
may need to raise additional capital in the future resulting in dilution
to our
stockholders.
We
may
need to raise additional funds for our business operations and to execute
our
business strategy. We may seek to sell additional equity or debt securities
or
to obtain an additional credit facility. The sale of additional equity or
convertible debt securities could result in additional dilution to our
stockholders. If additional funds are raised through the issuance of debt
securities, these securities could have rights that are senior to holders
of
common stock and could contain covenants that would restrict our operations.
Any
additional financing may not be available in amounts or on terms acceptable
to
us, if at all. Failure to obtain sufficient funds on acceptable terms when
needed or to make timely debt payments may require us to curtail operations,
perhaps to a significant extent.
Our
executive officers and directors could exert significant influence over matters
requiring stockholder approval.
Our
executive officers and directors, and their respective affiliates, own
approximately 4.6% of our outstanding common stock as of June 30, 2005. These
stockholders may, as a practical matter, be able to exert significant influence
over matters requiring approval by our stockholders, including the election
of
directors and the approval of mergers or other business combinations. This
concentration of voting stock could have the effect of delaying or preventing
a
merger or acquisition or other change of control that a stockholder may consider
favorable.
The
proceeds from the sale of the shares of common stock offered pursuant to
this
prospectus are solely for the account of the selling securityholder. As such
we
will not receive any of the proceeds from the sale of these shares. As of
September 12, 2005, the last sale price of our common stock on the Nasdaq
National Market was $3.79.
TRANSACTIONS
WITH SELLING SECURITYHOLDER
On
August
5, 2005, we issued in a private placement subordinated Senior Convertible
Notes
with an aggregate principal amount of $9.7 million to Atlas Master Fund,
Ltd.
The notes are convertible into shares of our common stock at an initial
conversion price of $4.03 per share of common stock. The conversion price
is
subject to adjustment in certain circumstances. The
notes
bear interest at a rate of 6.5% per year, which interest is payable
semi-annually on December 15 and June 15 each year, beginning December 15,
2005,
and are due on August 5, 2008. During the occurrence of an “Event of Default”
under the notes, the notes will bear interest at a rate of 12% per year.
The
notes are subordinate in right of payment to our existing “Senior Debt”, which
as of September 1, 2005 consists of the
Agreement by and among Steven Picheny, Howard Fuchs and the Company dated
as of
March 14, 2002, as amended. The notes will also be subordinate in right of
payment to a working capital line in an amount not to exceed $10 million
into
which we may enter in the future.
If
on the
maturity date of the notes, the closing price of our common stock has been
at or
above 102% of the then current conversion price for at least 10 consecutive
business days immediately preceding August 5, 2008, then any remaining principal
outstanding under the notes shall automatically be converted into shares
of our
common stock, subject to certain conditions set forth in the
notes.
SELLING
SECURITYHOLDER
The
following table sets forth certain information as of August 26, 2005 with
respect to the selling securityholder. We are unable to determine the exact
number of shares that actually will be sold by the selling securityholder.
We do
not know how long the selling securityholder will hold the shares before
selling
them. We assume the selling securityholder will sell all shares offered by
such
selling securityholder in this prospectus.
We
have
determined beneficial ownership in accordance with the rules of the Securities
and Exchange Commission. Except as indicated by the footnotes below, we believe,
based on the information furnished to us, that entity named in the table
below
have sole voting and investment power with respects to all shares of common
stock that it beneficially owns, subject to applicable community property
laws.
We have based our calculation of the percentage of beneficial ownership on
41,827,313 shares of common stock outstanding on August 26, 2005.
Except
as
indicated in “Transactions with Selling Securityholder” on page 9 of this
prospectus, or by the footnotes below, the selling securityholder has not
had
any material relationship with us or any of our predecessors or affiliates
within the last three years. Except as indicated by the footnotes below,
the
selling securityholder is not a broker-dealer or affiliate of broker-dealers.
The selling securityholder acquired the shares being offered in this prospectus
in the ordinary course of business and at the time of acquisition the selling
securityholder had no direct or indirect agreements or understandings with
any
person to distribute such shares. Information about the selling securityholder
may change over time. Any changed information given to us by the selling
securityholder will be set forth in prospectus supplements if and when
necessary.
| |
|
Percentage
of Shares of
Common
Stock Owned
|
|
|
Selling
Securityholder (1)
|
|
Number
of Shares of
Common
Stock
Beneficially
Owned
Before
the Offering (2)
|
|
Number
of Shares of
Common
Stock to be
Resold
in the Offering (3)
|
Shares
Offered
by
this
Prospectus
|
Before
Offering
of
the
Resale Shares
|
|
After
Offering of
the
Resale
Shares
(4)
|
|
|
Atlas
Master Fund, Ltd. (5)
c/o
Walkers SPV Limited
Walker
House, Mary Street
P.O.
Box 908 GT
Georgetown,
Grand Cayman
Cayman
Islands
|
|
3,911,345
|
|
2,406,947
|
2,406,947
|
8.8%
|
|
3.4%
|
|
|
*
|
|
Less
than 1.0%
|
|
|
(1)
|
|
This
table is based upon information supplied to us by the selling
securityholder as well as information set forth in the selling
securityholder’s Schedule 13G filed with the SEC on or about August 15,
2005.
|
|
|
(2)
|
|
Under
the rules of the SEC, a person is deemed to be a “beneficial owner” of a
security if that person has or shares “voting power”, which includes the
power to vote or to direct the voting of such security, or “investment
power,” which includes the power to dispose of or to direct the
disposition of such security. Under these rules, more than one
person may
be deemed to be a beneficial owner of the same securities and
a person may
be deemed to be a beneficial owner of securities as to which
he or she has
no economic or pecuniary interest. Except as set forth in the
footnotes
below, the selling stockholder has sole voting and investment
power with
respect to all shares of our common stock shown as being beneficially
owned by it. A person also is deemed to be a beneficial owner
of any
securities which that person has the right to acquire within
60 days.
|
|
|
(3)
|
|
Represents
shares of common stock issuable upon the conversion of subordinated
senior
convertible notes issued in connection with the private placement
transaction described under “Transactions with Selling Securityholder” on
page 9 of this prospectus.
|
|
|
(4)
|
|
For
the purposes of computing the number of shares of common stock
to be held
by the selling securityholder after the conclusion of the offering,
we
have assumed for purposes of the table above that the selling
securityholder named above will sell all of the shares of common
stock
issuable upon conversion of the subordinated senior convertible
notes
offered by this prospectus, and that any other shares of common
stock
beneficially owned by the selling securityholder will continue
to be
beneficially owned.
|
|
|
(5)
|
|
The
figure shown includes 2,406,947 shares issuable upon conversion
of
subordinated senior convertible notes issued in connection with
the
private placement transaction described under “Transactions with Selling
Securityholder” on page 9 of this prospectus, which notes are convertible
within 60 days after August 15, 2005. Atlas Global, LLC, a Delaware
limited liability company (“AG”), owns 19.1% of the equity interests in
the selling stockholder and may be deemed to beneficially own
all shares
of our common stock shown as beneficially owned by the selling
securityholder. Atlas Global Investments, Ltd., a Cayman Islands
corporation (“AGI1”), owns 73.4% of the equity interests in the selling
stockholder and may be deemed to beneficially own all shares
of our common
stock shown as beneficially owned by the selling securityholder.
Atlas
Global Investments II, Ltd., a Cayman Islands corporation (“AGI2”), owns
7.5% of the equity interests in the selling stockholder and may
be deemed
to beneficially own all shares of our common stock shown as beneficially
owned by the selling securityholder. Balyasny Asset Management
L.P., a
Delaware limited partnership (“BAM”), is the sole managing member of AG
and is the investment manager to each of AG, AGI1 and AGI2. By
virtue of
its position as investment manager of each of AG, AGI1 and AGI2
and its
role as sole managing member of AG, BAM may be deemed to beneficially
own
all shares of our common stock shown as beneficially owned by
the selling
securityholder. Dmitry Balyasny is the sole managing member of
the general
partner of BAM and as such, Mr. Balyasny may be deemed to beneficially
own
all shares of our common stock shown as beneficially owned by
the selling
securityholder.
|
|
We
are
registering shares on behalf of the selling securityholder. We are required
to
keep the Registration Statement on Form S-3 of which this prospectus is a
part
effective until the earlier of (i) the date when the selling securityholder
has
sold all the shares pursuant to the Registration Statement on Form S-3, (ii)
the
date on which all of the shares may be sold pursuant to Rule 144 under the
Securities Act or (iii) August 5, 2007. As used in this prospectus, “selling
securityholder” includes donees and pledgees selling shares received from the
named selling securityholder after the date of this prospectus. The shares
of
common stock offered hereby may be sold from time to time by the selling
securityholder for its own account. We will receive none of the proceeds
from
this offering. We will bear substantially all costs and expenses incident
to the
offering and sale of the shares to the public, including legal fees and
disbursements of counsel, “blue sky” expenses, accounting fees and filing fees,
but excluding any brokerage commissions, discounts or similar charges.
Resale
of
the shares by the selling securityholder is not subject to any underwriting
agreement. The shares of common stock covered by this prospectus may be sold
by
the selling securityholder or by its permitted pledgees, donees, transferees,
beneficiaries, distributees or successors-in-interest selling shares received
after the date of this prospectus from a selling securityholder as a gift,
pledge, partnership distribution or other non-sale related transfer. In
addition, certain of the selling securityholders are corporations or
partnerships which may, in the future, distribute their shares to their
stockholders or partners, respectively. Those shares may later be sold by
those
stockholders or partners. The selling securityholder will act independently
of
us in making decisions with respect to the timing, manner and size of each
sale.
The shares offered by each selling securityholder may be sold from time to
time:
| · |
at
market prices prevailing at the time of
sale,
|
| · |
at
prices relating to such prevailing market prices,
or
|
Such
sales may be effected in the over-the-counter market, on the Nasdaq National
Market, or on any exchange on which the shares may then be listed. We will
supply the selling securityholder with reasonable quantities of this prospectus.
The shares may be sold by one or more of the following:
| · |
one
or more block trades in which a broker or dealer so engaged will
attempt
to sell all or a portion of the shares held by the selling securityholders
as agent but may position and resell a portion of the block as
principal
to facilitate the transaction;
|
| · |
purchases
by a broker or dealer as principal and resale by such broker or
dealer for
its account pursuant to this
prospectus;
|
| · |
ordinary
brokerage transactions and transactions in which the broker solicits
purchasers;
|
| · |
in
negotiated transactions; and
|
To
the
extent permitted by law, the selling securityholder may enter into hedging
transactions when selling the shares. For example, the selling securityholder
may:
| · |
sell
shares short and redeliver such shares to close out its short
positions;
|
| · |
enter
into transactions involving short sales by the brokers or
dealers;
|
| · |
enter
into option or other types of transactions that require the selling
securityholder to deliver shares to a broker or dealer, who then
resells
or transfer the shares under this prospectus;
or
|
| · |
loan
or pledge the shares to a broker or dealer, who may sell the loaned
shares
or, in the event of default, sell the pledged
shares.
|
There
is
no assurance that the selling securityholder will sell any or all of the
shares
offered by it.
The
selling securityholder may effect sales through customary brokerage channels,
either through broker-dealers acting as agents or brokers, or through
broker-dealers acting as principals, who may then resell the shares, or at
private sales or otherwise, at market prices prevailing at the time of sale,
at
prices related to such prevailing market prices or at negotiated prices.
The
selling securityholder may effect such transactions by selling shares to
or
through broker-dealers, and such broker-dealers may receive compensation
in the
form of underwriting discounts, concessions, commissions or fees from the
selling securityholders and/or purchasers of the shares for whom such
broker-dealers may act as agent or to whom they sell as principal, or both
(which compensation to a particular broker-dealer might be in excess of
customary commissions). The selling securityholder may further agree to
indemnify any broker-dealer or agent against certain liabilities related
to the
selling of the common stock, including liabilities arising under the Securities
Act. Any broker-dealers that participate with the selling securityholder
in the
distribution of the shares may be deemed to be underwriters, and any commissions
received by them and any profit on the resale of the shares positioned by
them
might be deemed to be underwriting compensation, within the meaning of the
Securities Act, in connection with such sales. To the extent required, this
prospectus may be amended or supplemented from time to time to describe a
specific plan of distribution.
Any
shares covered by the prospectus that qualify for resale pursuant to Rule
144
under the Securities Act may be sold under Rule 144 rather than pursuant
to this
prospectus. In addition to selling the shares of common stock, the selling
securityholder may transfer the shares by gift, distribution or other transfer
not involving market makers or established trading markets.
The
shares of common stock offered pursuant to this prospectus will be originally
issued by us to the selling securityholder upon conversion of subordinated
senior convertible notes which were originally issued by us to the selling
securityholder in a private placement transaction on August 5, 2005. As part
of
that transaction, we agreed to indemnify the selling securityholder against
certain liabilities, including liabilities arising under the Securities Act
that
could arise in connection with the sale of the shares by the selling
securityholders. The selling securityholder has also agreed to indemnify
us
against certain liabilities arising under the Securities Act.
The
validity of the issuance of the common stock offered hereby will be passed
upon
for us by Heller Ehrman LLP, 275 Middlefield Road, Menlo Park, California
94025.
Mark B. Weeks, a shareholder of Heller Ehrman LLP, is our Secretary.
The
consolidated financial statements and management’s assessment of the
effectiveness of internal control over financial reporting (which is included
in
Management’s Report on Internal Control over Financial Reporting) incorporated
in this prospectus by reference to the Annual Report on Form 10-K and Form
10-K/A for the year ended December 31, 2004 have
been
so incorporated in reliance on the reports (which contain an adverse opinion
on
the effectiveness of internal controls over financial reporting) of
PricewaterhouseCoopers LLP, an independent registered public accounting firm,
given on the authority of said firm as experts in auditing and
accounting.
The
consolidated financial statements and the related financial statement schedule
of Horizon Medical Products, Inc. as of December 31, 2002 and 2003 and for
each
of the two years in the period ended December 31, 2003 incorporated by reference
in this prospectus have been audited by Grant Thornton LLP, an independent
registered public accounting firm, as stated in their report, given on the
authority of said firm as experts in auditing and accounting.
The
consolidated financial statements and the related financial statement schedule
of Horizon Medical Products, Inc. for the year ended December 31, 2001
incorporated in this Prospectus by reference to the Current Report on Form
8-K
of RITA Medical Systems, Inc. dated July 29, 2004 have been so incorporated
in
reliance on the reports of PricewaterhouseCoopers LLP, an independent registered
public accounting firm, given on the authority of said firm as experts in
auditing and accounting.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
We
file
annual, quarterly and current reports, proxy statements and other information
with the Securities and Exchange Commission. You may read and copy any of
these
reports, statements or other information at the Securities and Exchange
Commission’s public reference room located at 450 Fifth Street, N.W., Washington
D.C. 20549. Please call the Securities and Exchange Commission at 1-800-SEC-0330
for further information on the public reference room. Our Securities and
Exchange Commission filings are also available to the public from commercial
document retrieval services and at the web site maintained by the Securities
and
Exchange Commission at www.sec.gov.
We
also
make our annual, quarterly and current reports and proxy statements available
free of charge as soon as reasonably practicable after we file these reports
with the Securities and Exchange Commission. Our internet website is
www.ritamedical.com. Information on our web site is not incorporated by
reference into this prospectus.
Our
common stock is quoted on the Nasdaq National Market. Reports, proxy and
information statements and other information concerning us may be inspected
at
the Nasdaq Stock Market at 1735 K Street, NW, Washington, D.C. 20006.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
Securities and Exchange Commission allows us to “incorporate by reference”
information into this prospectus, meaning that we can disclose important
information by referring to another document filed separately with the
Securities and Exchange Commission. The information incorporated by reference
is
deemed to be part of this prospectus, except for any information superseded
by
information in, or incorporated by reference in, this prospectus. This
prospectus incorporates by reference the documents set forth below that we
have
previously filed with the Securities and Exchange Commission.
|
SECURITIES
AND EXCHANGE
COMMISSION
FILINGS
|
|
PERIOD
/ FILING DATE
|
|
| |
|
|
|
|
Annual
Report on Form 10-K, as amended (including the Annual Report on
Form 10-K
and the Annual Report on Form 10-K/A)
|
|
Fiscal
Year ended December 31, 2004
|
|
|
Quarterly
Report on Form 10-Q
|
|
Three
months ended March 31, 2005 and three months ended June 30, 2005
|
|
|
Definitive
Proxy Statement on Schedule 14A
|
|
Filed
on May 2, 2005 for our Annual Meeting of Stockholders held on June
8,
2005
|
|
|
Current
Reports on Form 8-K
|
|
Filed
on August 9, 2004, January 7, 2005, January 21, 2005, January 31,
2005,
February 16, 2005, April 4, 2005, April 4, 2005, April 7, 2005,
April 20,
2005, May 24, 2005, May 27, 2005, June 24, 2005, July 5, 2005,
July 28,
2005, August 9, 2005, and August 9, 2005
|
|
|
The
description of our common stock contained in the Registration Statement
on
Form 8-A filed pursuant to Section 12 of the Exchange Act, and
any
amendment or report filed with the Securities and Exchange Commission
for
the purpose of updating such description.
|
|
Filed
on July 7, 2000
|
|
|
The
description of our Preferred Share Purchase Rights contained in
the
Registration Statement on Form 8-A filed pursuant to Section 12
of the Exchange Act, and any amendment or report filed with the
Securities
and Exchange Commission for the purpose of updating such description.
|
|
Filed
on August 7, 2001
|
|
We
are
also incorporating by reference additional documents that we have filed with
the
Securities and Exchange Commission under Section 13(a), 13(c), 14 or 15(d)
of
the Exchange Act (i) after the initial filing of the registration
statement
that contains this prospectus and prior to effectiveness of such registration
statement, and (ii) from the date of this prospectus until the selling
securityholder has sold all the shares of common stock; provided, however,
that
we are not incorporating any information furnished pursuant to Item 9 or
Item 12
(or, as of and after August 23, 2004, Item 7.01 or Item 2.02) of any current
report on Form 8-K. These documents incorporated herein by reference may
include
annual reports on Form 10-K, quarterly reports on Form 10-Q
and
current reports on Form 8-K, as well as proxy statements.
You
can
obtain any of these documents through us or the Securities and Exchange
Commission. Documents incorporated by reference are available from us without
charge. You may obtain documents incorporated by reference in this prospectus
by
requesting them in writing or by telephone from us at the following address:
RITA
Medical Systems, Inc.
46421
Landing Parkway
Fremont,
CA 94538
Attention:
Corporate Secretary
(510)
771-0400
WE
HAVE NOT AUTHORIZED ANY DEALER, SALES PERSON OR OTHER PERSON TO GIVE ANY
INFORMATION OR TO MAKE ANY REPRESENTATIONS OTHER THAN THOSE CONTAINED IN
THIS
PROSPECTUS OR ANY PROSPECTUS SUPPLEMENT. YOU MUST NOT RELY ON ANY UNAUTHORIZED
INFORMATION. THIS PROSPECTUS IS NOT AN OFFER OF THESE SECURITIES IN ANY STATE
WHERE AN OFFER IS NOT PERMITTED. THE INFORMATION IN THIS PROSPECTUS AS OF
THE
DATE ON THE FRONT OF THIS DOCUMENT. YOU SHOULD NOT ASSUME THAT THIS PROSPECTUS
IS ACCURATE AS OF ANY OTHER DATE.