e424b3
|
|
|
PROSPECTUS SUPPLEMENT NO. 18 |
|
Filed pursuant to Rule 424(b)(3) |
(To Prospectus dated May 1, 2006) |
|
Registration No. 333-133072 |
UROPLASTY, INC.
1,918,809 Shares of Common Stock
and
1,180,928 Shares of Common Stock
Issuable Upon Exercise of Warrants
This prospectus supplement relates to shares of our common stock that may be sold at various times
by certain selling shareholders. You should read this prospectus supplement no. 18, the prior
prospectus supplements and the prospectus dated May 1, 2006, which are to be delivered with this
prospectus supplement. Our May 1, 2006 prospectus is a combined prospectus under Rule 429(a) of
the Securities Act of 1933, as amended, with our prior prospectus dated July 29, 2005 and
supplements thereto (See Registration No. 333-126737 filed with the Securities and Exchange
Commission on July 20, 2005 and declared effective on July 29, 2005).
This prospectus supplement contains our
Quarterly Report on Form 10-QSB for the third quarter of
fiscal 2007 ended December 31, 2006. This report was filed with the Securities and Exchange
Commission on February 12, 2007. The attached information supplements and supersedes, in part, the
information contained in the prospectus.
Our common stock is traded on the
American Stock Exchange under the symbol UPI. On February 9,
2006, the closing price of our common stock on the American Stock Exchange was $2.64 per share.
This investment is speculative and
involves a high degree of risk. See Risk Factors on page 6 of
the prospectus to read about factors you should consider before buying shares of the common stock.
Neither the SEC nor any state
securities commission has approved or disapproved these securities or
passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a
criminal offense.
Prospectus Supplement
dated February 12, 2007
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-QSB
Quarterly Report Under section 13 or 15(d) of the Securities Exchange Act of 1934
For the Quarterly Period Ended December 31, 2006
Commission File No. 000-20989
UROPLASTY, INC.
(Name of Small Business Issuer in its Charter)
|
|
|
Minnesota, U.S.A.
(State or other jurisdiction of
incorporation or organization)
|
|
41-1719250
(I.R.S. Employer
Identification No.) |
5420 Feltl Road
Minnetonka, Minnesota, 55343
(Address of principal executive offices)
(912) 426-6140
(Issuers telephone number, including area code)
Securities registered under Section 12(g) of the Exchange Act: Common Stock, $.01 par value (Title of class)
Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the
past 12 months (or for such shorter period that the Company was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days.
YES þ NO o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act:
YES o NO þ
The number
of shares outstanding of the issuers only class of common stock
on January 24, 2007 was 10,946,442.
Transitional Small Business Disclosure Format:
YES o NO þ
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 (unaudited) |
|
|
March 31, 2006 |
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,714,498 |
|
|
$ |
1,563,433 |
|
Short-term investments |
|
|
|
|
|
|
1,137,647 |
|
Accounts receivable, net |
|
|
1,156,166 |
|
|
|
716,587 |
|
Income tax receivable |
|
|
154,780 |
|
|
|
270,934 |
|
Inventories |
|
|
990,230 |
|
|
|
757,062 |
|
Other |
|
|
212,230 |
|
|
|
353,178 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
8,227,904 |
|
|
|
4,798,841 |
|
|
|
|
|
|
|
|
|
|
Property, plant, and equipment, net |
|
|
1,429,199 |
|
|
|
1,079,438 |
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
333,281 |
|
|
|
411,604 |
|
|
|
|
|
|
|
|
|
|
Deferred tax assets |
|
|
188,455 |
|
|
|
111,361 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
10,178,839 |
|
|
$ |
6,401,244 |
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 2
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006
(unaudited) |
|
|
March 31, 2006 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Current maturities long-term debt |
|
$ |
45,409 |
|
|
$ |
41,658 |
|
Deferred rent current |
|
|
35,000 |
|
|
|
|
|
Notes payable |
|
|
29,345 |
|
|
|
|
|
Accounts payable |
|
|
616,495 |
|
|
|
506,793 |
|
Accrued liabilities |
|
|
874,240 |
|
|
|
917,981 |
|
Warrant liability |
|
|
515,041 |
|
|
|
665,356 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,115,530 |
|
|
|
2,131,788 |
|
|
|
|
|
|
|
|
|
|
Long-term debt less current maturities |
|
|
445,920 |
|
|
|
389,241 |
|
Deferred rent less current portion |
|
|
222,732 |
|
|
|
|
|
Accrued pension liability |
|
|
742,083 |
|
|
|
473,165 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
3,526,265 |
|
|
|
2,994,194 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Common stock $.01 par value;
40,000,000
shares authorized, 10,944,388 and
6,937,786 shares issued and
outstanding at December 31 and
March 31, 2006, respectively |
|
|
109,444 |
|
|
|
69,378 |
|
Additional paid-in capital |
|
|
21,865,848 |
|
|
|
14,831,787 |
|
Accumulated deficit |
|
|
(14,997,486 |
) |
|
|
(11,034,100 |
) |
Accumulated other comprehensive loss |
|
|
(325,232 |
) |
|
|
(460,015 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
6,652,574 |
|
|
|
3,407,050 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
10,178,839 |
|
|
$ |
6,401,244 |
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 3
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
2,158,273 |
|
|
$ |
1,592,526 |
|
|
$ |
5,683,253 |
|
|
$ |
4,793,134 |
|
Cost of goods sold |
|
|
752,181 |
|
|
|
391,163 |
|
|
|
1,760,553 |
|
|
|
1,274,308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
1,406,092 |
|
|
|
1,201,363 |
|
|
|
3,922,700 |
|
|
|
3,518,826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
732,498 |
|
|
|
859,321 |
|
|
|
2,443,897 |
|
|
|
2,294,752 |
|
Research and development |
|
|
424,987 |
|
|
|
700,203 |
|
|
|
1,758,350 |
|
|
|
2,361,609 |
|
Selling and marketing |
|
|
1,301,575 |
|
|
|
852,483 |
|
|
|
3,837,858 |
|
|
|
2,321,122 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,459,060 |
|
|
|
2,412,007 |
|
|
|
8,040,105 |
|
|
|
6,977,483 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(1,052,968 |
) |
|
|
(1,210,644 |
) |
|
|
(4,117,405 |
) |
|
|
(3,458,657 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
15,776 |
|
|
|
52,511 |
|
|
|
53,592 |
|
|
|
107,507 |
|
Interest expense |
|
|
(8,671 |
) |
|
|
(12,767 |
) |
|
|
(25,136 |
) |
|
|
(22,091 |
) |
Warrant benefit |
|
|
522,995 |
|
|
|
560,048 |
|
|
|
150,315 |
|
|
|
575,471 |
|
Foreign currency exchange gain
(loss) |
|
|
4,413 |
|
|
|
(7,374 |
) |
|
|
34,376 |
|
|
|
(15,779 |
) |
Other |
|
|
|
|
|
|
438 |
|
|
|
3,585 |
|
|
|
438 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
534,513 |
|
|
|
592,856 |
|
|
|
216,732 |
|
|
|
645,546 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(518,455 |
) |
|
|
(617,788 |
) |
|
|
(3,900,673 |
) |
|
|
(2,813,111 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
44,802 |
|
|
|
39,942 |
|
|
|
62,713 |
|
|
|
42,648 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(563,257 |
) |
|
$ |
(657,730 |
) |
|
$ |
(3,963,386 |
) |
|
$ |
(2,855,759 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share |
|
$ |
(0.07 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.51 |
) |
|
$ |
(0.43 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
8,555,586 |
|
|
|
6,878,251 |
|
|
|
7,766,463 |
|
|
|
6,695,674 |
|
See accompanying notes to the condensed consolidated financial statements.
Page 4
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS EQUITY AND COMPREHENSIVE LOSS
Nine months ended December 31, 2006
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Accumulated |
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Accumulated |
|
|
Other |
|
|
Shareholders |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Comprehensive Loss |
|
|
Equity |
|
Balance at March
31, 2006 |
|
|
6,937,786 |
|
|
$ |
69,378 |
|
|
$ |
14,831,787 |
|
|
$ |
(11,034,100 |
) |
|
$ |
(460,015 |
) |
|
$ |
3,407,050 |
|
|
Proceeds from
private placement,
net of costs of $274,825 |
|
|
1,389,999 |
|
|
|
13,900 |
|
|
|
1,796,324 |
|
|
|
|
|
|
|
|
|
|
|
1,810,224 |
|
|
Proceeds from
follow-on offering,
net of costs of $564,044 |
|
|
2,430,000 |
|
|
|
24,300 |
|
|
|
4,271,706 |
|
|
|
|
|
|
|
|
|
|
|
4,296,006 |
|
|
Warrant
registration costs |
|
|
|
|
|
|
|
|
|
|
(11,872 |
) |
|
|
|
|
|
|
|
|
|
|
(11,872 |
) |
|
Exercise of Stock
Options |
|
|
168,849 |
|
|
|
1,688 |
|
|
|
297,749 |
|
|
|
|
|
|
|
|
|
|
|
299,437 |
|
|
Employee Retirement
Savings Plan
Contribution |
|
|
17,754 |
|
|
|
178 |
|
|
|
44,207 |
|
|
|
|
|
|
|
|
|
|
|
44,385 |
|
|
Share-Based
Compensation |
|
|
|
|
|
|
|
|
|
|
635,947 |
|
|
|
|
|
|
|
|
|
|
|
635,947 |
|
|
Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,963,386 |
) |
|
|
134,783 |
|
|
|
(3,828,603 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December
31, 2006 |
|
|
10,944,388 |
|
|
$ |
109,444 |
|
|
$ |
21,865,848 |
|
|
$ |
(14,997,486 |
) |
|
|
($325,232 |
) |
|
$ |
6,652,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 5
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Nine Months Ended December 31, 2006 and 2005
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,963,386 |
) |
|
$ |
(2,855,759 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
222,547 |
|
|
|
178,130 |
|
Loss (Gain) on disposal of equipment |
|
|
(3,576 |
) |
|
|
478 |
|
Warrant benefit |
|
|
(150,315 |
) |
|
|
(575,471 |
) |
Stock-based consulting expense |
|
|
48,043 |
|
|
|
|
|
Stock-based compensation expense |
|
|
587,904 |
|
|
|
|
|
Deferred income taxes |
|
|
(64,694 |
) |
|
|
4,420 |
|
Deferred rent |
|
|
(23,333 |
) |
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(365,812 |
) |
|
|
(58,490 |
) |
Inventories |
|
|
(149,247 |
) |
|
|
(353,351 |
) |
Other current assets and income tax receivable |
|
|
288,974 |
|
|
|
(57,414 |
) |
Accounts payable |
|
|
91,619 |
|
|
|
37,554 |
|
Deferred rent |
|
|
281,065 |
|
|
|
|
|
Accrued liabilities |
|
|
(24,633 |
) |
|
|
275,446 |
|
Accrued pension liability |
|
|
214,909 |
|
|
|
(12,581 |
) |
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(3,009,935 |
) |
|
|
(3,417,038 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Proceeds from sale of short-term investments |
|
|
1,137,647 |
|
|
|
|
|
Purchases of property, plant and equipment |
|
|
(430,578 |
) |
|
|
(180,745 |
) |
Proceeds from sale of property, plant and equipment |
|
|
4,294 |
|
|
|
|
|
Payments for intangible assets |
|
|
|
|
|
|
(391,667 |
) |
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
711,363 |
|
|
|
(572,412 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from long-term obligations |
|
|
210,999 |
|
|
|
|
|
Repayment of long-term obligations |
|
|
(158,820 |
) |
|
|
(31,535 |
) |
Proceeds from issuance of common stock and warrants |
|
|
6,393,795 |
|
|
|
6,683,333 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
6,445,974 |
|
|
|
6,651,798 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
3,663 |
|
|
|
(95,995 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
4,151,065 |
|
|
|
2,566,353 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
1,563,433 |
|
|
|
1,492,684 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
5,714,498 |
|
|
$ |
4,059,037 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
22,011 |
|
|
$ |
14,253 |
|
Cash paid during the period for income taxes |
|
|
93,935 |
|
|
|
62,608 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash financing and investing activities: |
|
|
|
|
|
|
|
|
Shares issued for 401(k) plan profit sharing contribution |
|
$ |
44,385 |
|
|
$ |
|
|
Property, plant and equipment additions funded by lessor allowance and
classified as deferred rent |
|
|
280,000 |
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 6
UROPLASTY, INC. AND SUBSIDIARIES
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. Basis of Presentation
We have prepared our condensed consolidated financial statements included in this Form 10-QSB,
without audit, pursuant to the rules and regulations of the Securities and Exchange Commission.
Certain information and footnote disclosures normally included in the consolidated financial
statements prepared in accordance with accounting principles generally accepted in the United
States of America have been condensed or omitted, pursuant to such rules and regulations. The
consolidated results of operations for any interim period are not necessarily indicative of results
for a full year. These condensed consolidated financial statements should be read in conjunction
with the consolidated financial statements and related notes included in our Annual Report on Form
10-KSB for the year ended March 31, 2006.
The condensed consolidated financial statements presented herein as of December 31, 2006 and for
the three and nine-month periods ended December 31, 2006 and 2005 reflect, in the opinion of
management, all material adjustments consisting only of normal recurring adjustments necessary for
a fair presentation of the consolidated financial position, results of operations and cash flows
for the interim periods.
We have identified certain accounting policies that we consider particularly important for the
portrayal of our results of operations and financial position and which may require the application
of a higher level of judgment by our management, and as a result are subject to an inherent level
of uncertainty. These are characterized as critical accounting policies and address revenue
recognition, accounts receivable, inventories, foreign currency translation and transactions,
impairment of long-lived assets, share-based compensation and income taxes, each of which is more
fully described in our Annual Report on Form 10-KSB for the year ended March 31, 2006. Based upon
our review, we have determined that these policies remain our most critical accounting policies for
the three and nine-month periods ended December 31, 2006, and we have made no changes to these
policies during fiscal 2007.
2. Nature of Business, Sales of Common Stock and Corporate Liquidity
We are a medical device company that develops, manufactures and markets innovative, proprietary
products for the treatment of voiding dysfunctions. Our minimally invasive products treat urinary
incontinence and overactive bladder symptoms. We offer a diverse set of products to address the
various preferences of doctors and patients, as well as the quality of life issues presented by
voiding dysfunctions. We currently offer three medical devices for the treatment of incontinence
and overactive bladder symptoms: Macroplastique®, a minimally invasive, implantable soft tissue
bulking agent for the treatment of urinary incontinence; I-StopTM Mid-Urethral Sling, a
minimally invasive biocompatible, polypropylene, tension-free sling for the treatment of female
urinary incontinence; and the Urgent® PC neuromodulation system, a minimally invasive device
designed for office-based treatment of overactive bladder symptoms of urge incontinence, urinary
urgency and urinary frequency.
In October 2006, we received from the FDA pre-market approval for Macroplastique, a minimally
invasive, implantable soft tissue bulking agent for the treatment of urinary incontinence, sold in
over 40 countries outside the United States since 1991. We began marketing this product in the
United States in early 2007.
The majority of our revenue is from products sold outside of the United States. We have
established a sales force in the United States to commercialize these products and anticipate
increasing our sales and marketing organization.
Our future liquidity and capital requirements will depend on numerous factors including: acceptance
of our products, and the timing and cost involved in manufacturing scale-up and in expanding our
sales, marketing and distribution capabilities, in the United States markets; the cost and
effectiveness of our marketing and sales efforts with respect to our existing products in
international markets; the effect of competing technologies and market and regulatory developments;
and the cost involved in protecting our proprietary rights. Because we have yet to achieve
profitability and generate positive cash flows, we will need to raise additional debt or equity
financing to continue funding for product development, continued expansion of our sales and
marketing activities and planned growth activities beyond fiscal 2008. There can be no guarantee
that we will be successful, as we currently have no committed sources of, or other arrangements
with respect to, additional equity or debt financing, aside from the recently established credit
lines. We therefore cannot ensure that we will obtain additional
Page 7
financing on acceptable terms, or
at all. Ultimately, we will need to achieve profitability and generate positive cash flows from
operations to fund our operations and grow our business.
In October 2006, we amended our business loan agreement with Venture Bank. The amended agreement
provides for a credit line of up to $500,000 secured by substantially all of our assets. We may
borrow up to 50% of the value of the inventory on hand in the U.S. and 75% of the U.S. accounts
receivable value. The bank charges us interest on the loan at the rate of 1 percentage point over
the prime rate (8.25% at December 31, 2006) subject to a minimum interest rate of 7% per annum.
In June 2006, we entered into a $100,000 3-year, term loan agreement with Venture Bank, at an
interest rate of 8.25% per annum. In addition, Uroplasty BV, our subsidiary, entered into an
arrangement with Rabobank of The Netherlands for a 200,000 (approximately $264,000) credit line.
At December 31, 2006, we had no borrowings against any of our credit lines.
3. Short-term Investments
At March 31, 2006, short-term investments consisted of certificates of deposit that matured in the
first quarter of fiscal 2007.
4. Inventories
Inventories are stated at the lower of cost (first-in, first-out method) or market (net realizable
value) and consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
March 31, 2006 |
|
|
Raw materials |
|
$ |
335,847 |
|
|
$ |
340,268 |
|
Work-in-process |
|
|
6,454 |
|
|
|
26,183 |
|
Finished goods |
|
|
647,929 |
|
|
|
390,611 |
|
|
|
|
|
|
|
|
|
|
|
$ |
990,230 |
|
|
$ |
757,062 |
|
|
|
|
|
|
|
|
5. Intangible Assets
Intangible assets are comprised of patents, trademarks and licensed technology which are amortized
on a straight-line basis over their estimated useful lives or contractual terms, whichever is less.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
|
Estimated Lives |
|
Gross Carrying |
|
|
Accumulated |
|
|
|
|
|
|
(Years) |
|
Amount |
|
|
Amortization |
|
|
Net value |
|
|
Licensed technology |
|
5 |
|
$ |
501,290 |
|
|
$ |
184,624 |
|
|
$ |
316,666 |
|
Patents and inventions |
|
6 |
|
|
237,900 |
|
|
|
221,285 |
|
|
|
16,615 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
|
|
$ |
739,190 |
|
|
$ |
405,909 |
|
|
$ |
333,281 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2006 |
|
Licensed technology |
|
5 |
|
$ |
501,290 |
|
|
$ |
111,183 |
|
|
$ |
390,107 |
|
Patents and inventions |
|
6 |
|
|
237,900 |
|
|
|
216,403 |
|
|
|
21,497 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
|
|
$ |
739,190 |
|
|
$ |
327,586 |
|
|
$ |
411,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Page 8
Estimated annual amortization for these assets for the fiscal years ended March 31 is as follows:
|
|
|
|
|
Remainder of fiscal 2007 |
|
$ |
25,189 |
|
2008 |
|
|
100,756 |
|
2009 |
|
|
100,652 |
|
2010 |
|
|
98,369 |
|
2011 |
|
|
8,315 |
|
|
|
|
|
|
|
$ |
333,281 |
|
|
|
|
|
6. Deferred Rent
We entered into an 8-year operating lease agreement, effective May 2006, for our corporate
facility. As part of the agreement, the landlord provided an incentive of $280,000 for leasehold
improvement. This incentive is recorded as deferred rent and amortized as reduction in lease
expense over the lease term in accordance to SFAS 13, Accounting for Leases and FASB Technical
Bulletin 88-1, Issues Relating to Accounting for Leases. The leasehold improvements are
amortized and charged to expense over the shorter of asset life or the lease term.
7. Comprehensive Loss
Comprehensive loss consists of net loss, translation adjustments and additional pension liability
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
Net loss |
|
$ |
(563,257 |
) |
|
$ |
(657,730 |
) |
|
$ |
(3,963,386 |
) |
|
$ |
(2,855,759 |
) |
Items of other comprehensive
income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
77,297 |
|
|
|
(49,309 |
) |
|
|
155,394 |
|
|
|
(264,181 |
) |
Additional pension liability |
|
|
(8,792 |
) |
|
|
1,101 |
|
|
|
(20,611 |
) |
|
|
5,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(494,752 |
) |
|
$ |
(705,938 |
) |
|
$ |
(3,828,603 |
) |
|
$ |
(3,114,227 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
8. Options and Warrants
The following options and warrants outstanding at December 31, 2006 and 2005 to purchase shares of
common stock were excluded from diluted loss per common share because of their anti-dilutive
effect:
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
Range of Exercise |
|
|
Options/Warrants |
|
Prices |
|
For the three and nine months ended: |
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
4,953,229 |
|
$1.10 to $5.30 |
December 31, 2005 |
|
|
3,764,139 |
|
$0.90 to $10.50 |
9. Shareholders Equity
Warrants
As a result of the suspension of the exercise of the 706,218 warrants we originally issued in July
2002, we granted a like number of new common stock purchase warrants to the holders of the expired
warrants in April 2005. The U.S. Securities and Exchange Commission declared the registration
statement for the resale of the shares underlying these warrants effective on December 19, 2006.
The new warrants are exercisable at $2.00 per share at any time up to March 19, 2007. In April
2005, we recognized a liability and a charge to equity of approximately $1.4 million associated
with the grant of these new
Page 9
warrants. We determined the fair value of these warrants using the Black-Scholes option-pricing
model. We have since reduced the reported liability to approximately $515,000 due to the decrease
in the fair value of these warrants from their date of issuance through December 31, 2006. We
recorded a warrant benefit of approximately $523,000 and $560,000 for the three months ended
December 31, 2006 and 2005, respectively, and $150,000 and $575,000 for the nine months ended
December 31, 2006 and 2005, respectively. In accordance with EITF 00-19, we recognized the
liability associated with the grant of the new warrants and we will continue to remeasure the value
of this liability in relation to its fair value and adjust accordingly until such time as the
warrants are exercised or expire.
We used the following assumptions to remeasure the value the warrants at December 31, 2006:
|
|
|
|
|
Expected life in years |
|
|
0.2137 |
|
Risk-free interest rate |
|
|
4.98 |
% |
Expected volatility |
|
|
111.19 |
% |
Expected dividend yield |
|
|
0 |
|
The expected life represents the remaining period of time we expect the warrants to be outstanding.
The risk-free interest rate is based on the U.S. Treasury rate over the expected life at December
31, 2006, the measure date. The expected volatility is based upon the historical volatility of our
stock.
In connection with our April 2005 private placement, we issued 1,180,928 warrants to purchase
shares of common stock and registered the public resale of the underlying shares for the security
holders. The warrants are exercisable for five years at an exercise price of $4.75.
As part of a consulting agreement with CCRI Corporation, we issued a warrant to purchase 50,000
shares of common stock at a price of $3.00 per share on April 1, 2003, and an additional warrant to
purchase 50,000 shares at a price of $5.00 on November 2, 2003. At June 30, 2006, all of these
warrants were outstanding and expire five years from the date of issue. We have registered the
public resale of the underlying shares.
In connection with our August 2006 private placement, we issued 695,000 warrants to purchase shares
of our common stock. We also sold to the placement agent a warrant to purchase 69,500 shares of
our common stock. We registered the public resale of the underlying shares for the security
holders. The warrants are exercisable for five years, beginning on February 4, 2007, at an
exercise price of $2.50 per share.
In connection with our December 27, 2006 follow-on stock offering, we sold to the placement agent a
warrant to purchase 121,050 shares of our common stock. We registered the public resale of the
underlying shares for the security holder. The warrants are exercisable for five years at an
exercise price of $2.40 per share.
10. Share-based Compensation
As of December 31, 2006, we had one active plan (2006 Stock and Incentive Plan) for share-based
compensation awards. Under the plan, if we have a change in control, all outstanding awards,
including those subject to vesting or other performance targets, fully vest immediately. We have
reserved 1,200,000 shares of our common stock for stock-based awards under this plan, and as of
December 31, 2006, we had granted awards for 223,000 options. We generally grant option awards
with an exercise price equal to the closing market price of our stock at the date of the grant.
On April 1, 2006, we adopted Statement of Financial Accounting Standards No. 123(R), Share-Based
PaymentRevised 2004 (SFAS No. 123(R)), using the modified prospective transition method.
Prior to the adoption of SFAS No. 123(R), we accounted for stock option grants in accordance with
APB Opinion No. 25, Accounting for Stock Issued to Employees (the intrinsic value method), and
accordingly, recognized no compensation expense for stock option grants.
Under the modified prospective method, we recognize share-based employee compensation cost using
the fair-value based method for all new awards granted on or after April 1, 2006 and to awards
granted prior to April 1, 2006 that we subsequently modify, repurchase or cancel. We recognize
compensation costs for unvested stock options and awards that were outstanding as of the April 1,
2006 adoption date, over the remaining requisite service period based on the grant-date fair value
of those options and awards as previously calculated under the pro-forma disclosures pursuant to
Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation
(SFAS No. 123). We were not required to restate prior periods to reflect the impact of adopting
the new standard. We incurred a total of approximately $140,000 and $588,000 in compensation
expense for the three and nine months ended December 31, 2006, respectively, as a result of our
adoption of SFAS No. 123(R).
Page 10
Proceeds from the exercise of stock options were $152,280 and $299,437 for the three and nine
months ended December 31, 2006.
The following table illustrates the effect on operating results and per share loss had we accounted
for stock-based compensation in accordance with SFAS No. 123(R) for the three and nine months ended
December 31, 2005.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, 2005 |
|
|
December 31, 2005 |
|
|
|
|
|
|
|
|
|
|
Net loss As reported |
|
$ |
(657,730 |
) |
|
$ |
(2,855,759 |
) |
Deduct: Pro forma stock-based employee
compensation expense determined under
fair value-based method |
|
|
(274,235 |
) |
|
|
(1,268,423 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss Pro forma |
|
$ |
(931,965 |
) |
|
$ |
(4,124,182 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share As reported: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.10 |
) |
|
$ |
(0.43 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share Pro forma: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.14 |
) |
|
$ |
(0.62 |
) |
We determined the fair value of our option awards using the Black-Scholes option pricing model. We
used the following weighted-average assumptions to value the options granted during the three and
nine months ended December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, 2006 |
|
|
December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
Expected life in years |
|
|
3.18 |
|
|
|
7.40 |
|
Risk-free interest rate |
|
|
4.74 |
% |
|
|
4.96 |
% |
Expected volatility |
|
|
100.26 |
% |
|
|
100.26 |
% |
Expected dividend yield |
|
|
0 |
|
|
|
0 |
|
Weighted-average fair value |
|
|
1.84 |
|
|
|
1.95 |
|
The expected life selected for options granted during the quarter represents the period of time
that we expect our options to be outstanding based on historical data of option holder exercise and
termination behavior for similar grants. The risk-free interest rate for periods within the
contractual life of the option is based on the U.S. Treasury rate over the expected life at the
time of grant. Expected volatilities are based upon historical volatility of our stock.
As of December 31, 2006, we had approximately $522,967 of unrecognized compensation cost related to
share-based payments that we expect to recognize over a weighted-average period of 1.54 years.
Page 11
The following table summarizes activity related to our stock options during the nine months ended
December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Avg. |
|
|
|
|
|
|
Weighted Avg. |
|
Remaining |
|
|
Number of Shares |
|
Exercise Price |
|
Contract Life |
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at beginning of
period |
|
|
1,888,327 |
|
|
$ |
3.80 |
|
|
|
4.48 |
|
Options granted |
|
|
543,000 |
|
|
|
2.32 |
|
|
|
6.92 |
|
Options exercised |
|
|
(168,849 |
) |
|
|
1.77 |
|
|
|
|
|
Options surrendered |
|
|
(181,945 |
) |
|
|
2.98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at end of period |
|
|
2,080,533 |
|
|
$ |
3.66 |
|
|
|
5.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at end of period |
|
|
1,686,615 |
|
|
$ |
3.95 |
|
|
|
4.70 |
|
11. Savings and Retirement Plans
We sponsor various plans for eligible employees in the United States, the United Kingdom (UK), and
The Netherlands. Our retirement savings plan in the United States conforms to Section 401(k) of
the Internal Revenue Code and participation is available to substantially all employees. We may
also make discretionary contributions ratably to all eligible employees. We made no discretionary
contributions in association with these plans in the United States for the three and nine month
periods ended December 31, 2006 and 2005, respectively.
Our international subsidiaries have defined benefit retirement plans for eligible employees. These
plans provide benefits based on each employees years of service and compensation during the years
immediately preceding retirement, termination, disability, or death, as defined in the plans. We
invest pension plan assets in insurance contracts. We closed the defined benefit plan in The
Netherlands for new employees effective April 2005. At that time, our Dutch subsidiary established
a defined contribution plan. We froze our UK subsidiarys defined benefit plan on December 31,
2004. On March 10, 2005, our UK subsidiary established a defined contribution plan.
The cost for our defined benefit retirement plans in The Netherlands and the United Kingdom
includes the following components for the three and nine-month periods ended December 31, 2006 and
2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross service cost |
|
$ |
51,882 |
|
|
$ |
48,134 |
|
|
$ |
153,727 |
|
|
$ |
148,359 |
|
Interest cost |
|
|
31,355 |
|
|
|
24,406 |
|
|
|
92,710 |
|
|
|
75,216 |
|
Expected return on assets |
|
|
(18,017 |
) |
|
|
(14,081 |
) |
|
|
(53,224 |
) |
|
|
(43,396 |
) |
Amortization |
|
|
10,737 |
|
|
|
6,869 |
|
|
|
31,772 |
|
|
|
21,172 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic retirement cost |
|
$ |
75,957 |
|
|
$ |
65,328 |
|
|
$ |
224,985 |
|
|
$ |
201,351 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Page 12
Major assumptions used in the above calculations include:
|
|
|
|
|
|
|
|
|
|
|
Three and Nine Months |
|
|
|
Ended |
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
Discount rate |
|
|
4.255.50 |
% |
|
|
4.505.25 |
% |
Expected return on assets |
|
|
4.005.00 |
% |
|
|
4.005.00 |
% |
Expected rate of increase in future compensation: |
|
|
|
|
|
|
|
|
General |
|
|
3 |
% |
|
|
3 |
% |
Individual |
|
|
0%3 |
% |
|
|
0%3 |
% |
12. Foreign Currency Translation
We translate all assets and liabilities using period-end exchange rates. We translate statements
of operations items using average exchange rates for the period. We record the resulting
translation adjustment within accumulated other comprehensive loss, a separate component of
shareholders equity. We recognize foreign currency transaction gains and losses in our
consolidated statements of operations, including unrealized gains and losses on short-term
intercompany obligations using period-end exchange rates. We recognize unrealized gains and losses
on long-term intercompany obligations within accumulated other comprehensive loss, a separate
component of shareholders equity.
We recognize exchange gains and losses primarily as a result of fluctuations in currency rates
between the U.S. dollar (the functional reporting currency) and the euro and British pound
(currencies of our subsidiaries), as well as their effect on the dollar denominated intercompany
obligations between us and our foreign subsidiaries. All intercompany balances are revolving in
nature and we do not deem them to be long-term balances. For the three months ended December 31,
2006 and 2005, we recognized foreign currency gain (loss) of $4,413 and $(7,374), respectively.
For the nine months ended December 31, 2006 and 2005, we recognized foreign currency gain (loss) of
$34,376 and $(15,779), respectively.
13. Income Tax Expense
During the three months ended December 31, 2006 and 2005, our Dutch subsidiaries recorded income
tax expense of $44,802 and $39,942, respectively. During the nine months ended December 31, 2006
and 2005, our Dutch subsidiaries recorded income tax expense of $62,713 and $42,648, respectively.
We cannot use our U.S. net operating loss carry forwards to offset taxable income in foreign
jurisdictions.
14. Business Segment and Geographic Information
We sell proprietary products for the treatment of voiding dysfunctions. Our minimally invasive
products treat urinary incontinence and overactive bladder symptoms. We currently offer three
medical devices for the treatment of incontinence and overactive bladder symptoms: Macroplastique,
a minimally invasive, implantable soft tissue bulking agent for the treatment of urinary
incontinence; I-Stop Mid-Urethral Sling, a minimally invasive biocompatible, polypropylene,
tension-free sling for the treatment of female urinary incontinence; and the Urgent PC
neuromodulation system, a minimally invasive device designed for office-based treatment of
overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency.
In October 2006, we received from the FDA pre-market approval for Macroplastique, a minimally
invasive, implantable soft tissue bulking agent for the treatment of urinary incontinence, sold in
over 40 countries outside the United States since 1991. We began marketing this product in the
United States in early 2007.
The Macroplastique product line accounted for 52% and 68%, respectively, of total net sales for the
nine months ended December 31, 2006 and 2005, respectively.
Based upon the above, we operate in only one reportable segment consisting of medical products for
the treatment of voiding dysfunctions primarily for the urology market.
Page 13
Information regarding operations in different geographies for the three and nine months ended
December 31, 2006 and 2005 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United |
|
The |
|
United |
|
|
|
|
|
|
States |
|
Netherlands |
|
Kingdom |
|
Eliminations * |
|
Consolidated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, three months ended
December 31, 2006 |
|
$ |
737,391 |
|
|
$ |
1,586,040 |
|
|
$ |
531,876 |
|
|
$ |
(697,034 |
) |
|
$ |
2,158,273 |
|
Sales, nine months ended
December 31, 2006 |
|
$ |
1,743,424 |
|
|
$ |
4,001,621 |
|
|
$ |
1,484,583 |
|
|
$ |
(1,546,375 |
) |
|
$ |
5,683,253 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense, three
months ended December 31,
2006 |
|
|
|
|
|
|
44,802 |
|
|
|
|
|
|
|
|
|
|
|
44,802 |
|
Income tax expense, nine
months ended December 31,
2006 |
|
|
|
|
|
|
62,713 |
|
|
|
|
|
|
|
|
|
|
|
62,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss), three
months ended December 31,
2006 |
|
|
(796,316 |
) |
|
|
145,649 |
|
|
|
128,873 |
|
|
|
(41,463 |
) |
|
|
(563,257 |
) |
Net income (loss), nine
months ended December 31,
2006 |
|
|
(4,151,691 |
) |
|
|
254,859 |
|
|
|
29,530 |
|
|
|
(96,084 |
) |
|
|
(3,963,386 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets
At December 31, 2006 |
|
|
1,007,348 |
|
|
|
749,890 |
|
|
|
5,242 |
|
|
|
|
|
|
|
1,762,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, three months ended
December 31, 2005 |
|
$ |
202,471 |
|
|
$ |
1,279,265 |
|
|
$ |
397,904 |
|
|
$ |
(287,114 |
) |
|
$ |
1,592,526 |
|
Sales, nine months ended
December 31, 2005 |
|
|
537,368 |
|
|
|
3,855,471 |
|
|
|
1,316,432 |
|
|
|
(916,137 |
) |
|
|
4,793,134 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense, three
months ended December 31,
2005 |
|
|
|
|
|
|
39,942 |
|
|
|
|
|
|
|
|
|
|
|
39,942 |
|
Income tax expense, nine
months ended December 31, 2005 |
|
|
|
|
|
|
42,648 |
|
|
|
|
|
|
|
|
|
|
|
42,648 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss), three
months ended December 31,
2005 |
|
|
(941,090 |
) |
|
|
212,498 |
|
|
|
(32,398 |
) |
|
|
103,260 |
|
|
|
(657,730 |
) |
Net income (loss), nine
months ended December 31,
2005 |
|
|
(3,238,877 |
) |
|
|
77,714 |
|
|
|
(662 |
) |
|
|
306,066 |
|
|
|
(2,855,759 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets
At December 31, 2005 |
|
|
688,264 |
|
|
|
709,035 |
|
|
|
6,775 |
|
|
|
|
|
|
|
1,404,074 |
|
|
|
|
* |
|
The information in the column entitled Eliminations represents intercompany transactions. |
15. Recently Issued Accounting Standards
In
July 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxesan
Interpretation of FASB Statement 109, or FIN 48, which clarifies the accounting for uncertainty in
tax positions. FIN 48 provides that the tax effects from an uncertain tax position be recognized
in financial statements, only if the position is more likely than not of being sustained on audit,
based on the technical merits of the position. The provisions of FIN 48 are effective as of the
beginning of our fiscal year 2008, with the cumulative effect of the change in accounting principle
recorded as an adjustment to opening retained earnings. We are currently evaluating the impact, if
any, of adopting FIN 48 on our financial statements.
In
September 2006, the FASB issued Statement 157, Fair Value
Measurements, or SFAS 157, which
defines fair value and establishes a framework for measuring fair value in generally accepted
accounting principles. SFAS 157 sets forth a standard definition of fair value as it applies to
assets or liabilities, the principal market (or most advantageous market) for determining fair
value (price), the market participants, inputs and the application of the derived fair value to
those assets and liabilities. The effective date of this pronouncement is for all full fiscal and
interim periods beginning after November 15, 2007. We are currently evaluating the impact, if any,
of adopting FASB Statement 157 on our financial statements.
In
September 2006, the FASB issued SFAS 158, Employers Accounting for Defined Benefit Pension and
Other Postretirement Plans (SFAS 158). SFAS 158 amends SFAS
No. 87, Employers Accounting for
Pensions, SFAS No. 88 Employers Accounting for Settlements and Curtailments of Defined Benefit
Pension Plans and for Termination Benefits, SFAS No. 106, Employers Accounting for Postretirement
Benefits Other than Pensions and SFAS 132, Employers
Page 14
Disclosures
about Pensions and Other Postretirement Benefits. The amendments retain most of the
existing measurement and disclosure guidance and will not change the amounts recognized in the
Companys statement of operations. SFAS 158 requires companies to recognize a net asset or
liability with an offset to equity, for the amount by which the defined-benefit-postretirement
obligation is over or under-funded. SFAS 158 requires prospective application, and the recognition
and disclosure requirements will be effective for our annual financial statements for the fiscal
year ending March 31, 2007. We are currently evaluating the impact, if any, of adopting SFAS 158
will have on our consolidated balance sheets.
In
September 2006, the SEC staff issued Staff Accounting Bulletin
(SAB) No. 108, Considering the
Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial
Statements (SAB 108). SAB 108 was issued in order to eliminate the diversity of practice in how
public companies quantify misstatements of financial statements, including misstatements that were
not material to prior years financial statements. We will initially apply the provisions of SAB
108 in connection with the preparation of our annual financial statements for the fiscal year
ending March 31, 2007. We do not believe the adoption of SAB 108 will have a material impact on
our financial statements.
16. Subsequent Events
In January 2007, Uroplasty BV, our subsidiary, amended its credit line agreement with Rabobank of
The Netherlands. The amended agreement increases the credit line, secured by a lien on our
facility in Geleen, The Netherlands, to 500,000 (approximately $660,000). The agreement requires
us to pay an annual credit facility fee of 0.4% of the credit line, and charges us interest on the
outstanding balance at the greater of 3.5 percent per annum or one percentage point above the
Rabobank base rate. At the date of the agreement, the Rabobank base rate was 4.25 percent per
annum.
In January 2007, in an effort to reduce costs and streamline our operations, our Board of Directors
approved a plan to close our manufacturing facility in Eindhoven, The Netherlands, and transfer the
production to our Minnetonka, Minnesota facility. We expect to complete the transition to, and
obtain the necessary regulatory approvals of, our manufacturing facility in Minnetonka in the
second half of 2007. The restructuring will result in the termination of employment of three
employees and the lease of the Eindhoven facility. We anticipate incurring approximately $315,000
to $445,000 of one-time, pre-tax exit charges during 2007, including approximately $10,000 to
$15,000 of non-cash charges related to asset impairment.
Page 15
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We recommend that you read this Report on Form 10-QSB in conjunction with our Annual Report on Form
10-KSB for the year ended March 31, 2006.
Forward-looking Statements
We may from time to time make written or oral forward-looking statements, including our
statements contained in this filing with the Securities and Exchange Commission and in our reports
to stockholders, as well as elsewhere. Forward-looking statements are statements such as those
contained in projections, plans, objectives, estimates, statements of future economic performance,
and assumptions related to any of the foregoing, and may be identified by the use of
forward-looking terminology, such as may, expect, anticipate, estimate, goal, continue,
or other comparable terminology. By their very nature, forward-looking statements are subject to
known and unknown risks and uncertainties relating to our future performance that may cause our
actual results, performance, or achievements, or industry results, to differ materially from those
expressed or implied in any such forward-looking statements. Any such statement is qualified by
reference to the following cautionary statements.
Our business operates in highly competitive markets and is subject to changes in general economic
conditions, competition, customer and market preferences, government regulation, the impact of tax
regulation, foreign exchange rate fluctuations, the degree of market acceptance of products, the
uncertainties of potential litigation, as well as other risks and uncertainties detailed elsewhere
herein and from time to time in our Securities and Exchange Commission filings.
In this filing, the section entitled Managements Discussion and Analysis of Financial Condition
and Results of Operations contains forward-looking statements. Various factors and risks (not all
of which are identifiable at this time) could cause our results, performance, or achievements to
differ materially from that contained in our forward-looking statements, and investors are
cautioned that any forward-looking statement contained herein or elsewhere is qualified by and
subject to the warnings and cautionary statements contained above and in our other filings with the
Securities and Exchange Commission.
We do not undertake, nor assume obligation, to update any forward-looking statement that we may
make from time to time.
Overview
We are a medical device company that develops, manufactures and markets innovative,
proprietary products for the treatment of voiding dysfunctions. Our minimally invasive products
treat urinary incontinence and overactive bladder symptoms. We believe that our company is uniquely
positioned because we offer a broad and diverse set of products to address the various preferences
of doctors and patients, as well as the quality of life issues presented by voiding dysfunctions.
We currently offer three medical devices for the treatment of incontinence and overactive bladder
symptoms.
Strategy
Our goal is to gain market share in the voiding dysfunction market by expanding our portfolio of
minimally invasive products for the treatment of voiding dysfunctions, with a particular focus on
products and applications for outpatient and office-based procedures. We believe that, with a
suite of innovative products, we can increasingly garner the attention of key physicians, our
independent sales representatives and distributors to enhance market acceptance of our products.
The key elements of our strategy are to:
|
|
|
Focus on office-based solutions for physicians. We believe that our company is uniquely
positioned to provide a broad product offering of office-based solutions for physicians.
By expanding our U.S. presence, we intend to develop long-standing relationships with
leading physicians treating incontinence and overactive bladder symptoms. These
relationships will provide us with a source of new product ideas and a conduit through
which to introduce new products. We have also intend to develop marketing programs to
assist physicians in marketing their practices and to provide innovative programs focused
on helping physicians attract patients and develop referral networks. Building these
relationships is an important part of our growth strategy, particularly for the development
and introduction of new products. |
|
|
|
|
Grow our U.S. sales and international distribution. We believe that in addition to
international market, the U.S. is a significant opportunity for future sales of our
products. In order to grow our U.S. business, we recently created our sales organization,
consisting of a direct field sales management team and independent sales representatives,
and a |
Page 16
|
|
|
marketing organization to market our products directly to our customers. We anticipate
further increasing, as needed, our sales and marketing organization in the United States to
support our sales growth. In addition, we intend to expand our European presence by
creating new distribution partnerships. |
|
|
|
Educate physicians and patients about the benefits of Urgent PC. We believe education
of physicians and patients regarding the benefits of Urgent PC is critical to the
successful adoption of this product. To this end, we have initiated a clinical trial,
which is a U.S. multi-center randomized prospective study comparing the Urgent PC device to
the most commonly prescribed pharmaceutical treatment for OAB symptoms. We believe the
results of this and other studies, if successful, will allow us to expand our marketing and
sales efforts. These sales and marketing efforts may include physician training and
education programs which will emphasize the clinical efficacy and ease of use of our Urgent
PC product as well as patient-oriented marketing materials for physicians to use to inform
patients of the availability and potential benefits of our Urgent PC product. |
|
|
|
|
Provide patient-driven alternatives. Patients often weigh the quality of life benefits
of electing to undergo a surgical procedure against the invasiveness of the procedure. We
intend to continue to expand our marketing efforts to build patient awareness of these
treatment alternatives and encourage patients to see physicians. We believe this will help
physicians build their practices and simultaneously increase sales of our products. |
|
|
|
|
Develop, license or acquire products. We believe that our broad and diverse product
offering is an important competitive advantage because it allows us to address the various
preferences of doctors and patients, as well as the quality of life issues presented by
voiding dysfunctions. Consolidation among hospital buying groups has reduced the number of
suppliers from which hospitals purchase products, providing an advantage to suppliers
offering a broad range of products. An important part of our growth strategy is to broaden
our product line further to meet customer needs by developing new products internally,
licensing or acquiring new products through acquisitions. |
Our Products
Macroplastique is a minimally invasive, implantable soft tissue bulking agent for the
treatment of urinary incontinence. When Macroplastique is injected into tissue around the urethra,
it stabilizes and bulks tissues close to the urethra, thereby providing the surrounding muscles
with increased capability to control the release of urine. Macroplastique has been sold for
urological indications in over 40 countries outside the United States since 1991. In October 2006,
we received from the FDA pre-market approval for Macroplastique. We began marketing this product
in the United States in early 2007. Following market introduction, we will conduct customary,
FDA-required post-approval studies to obtain market feedback on safety and effectiveness of the
product. We cannot assure that we can market Macroplastique profitability in the U.S.
I-Stop is a minimally invasive biocompatible, polypropylene, tension-free sling for the
treatment of female urinary incontinence. Our I-Stop sling can correct stress urinary incontinence
by providing tension-free hammock-type support for the urethra to prevent its downward movement and
the associated leakage of urine. In August 2005, FDA granted 510(k) clearance for the sale of
I-Stop within the United States.
The Urgent PC neuromodulation system is a minimally invasive device designed for office-based
treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary
frequency. This product uses percutaneous tibial nerve stimulation to deliver an electrical pulse
that travels to the sacral nerve plexus, a control center for bladder function. We received
regulatory approvals for the sale of Urgent PC in the United States and Canada in October 2005, and
in Europe in November 2005. Subsequently, we launched the product for sale in those markets. We
developed a second generation Urgent PC product during 2006. Following CE mark approval and 510(k)
clearance, we launched this product for sale in Europe in September 2006 and in the United States
in October 2006.
Sales and Marketing
We are focusing our sales and marketing efforts primarily on office-based and outpatient
surgery-based urologists, urogynecologists and gynecologists with significant patient volume. We
believe the United States is a significant opportunity for future sales of our products. In order
to grow our United States business, we recently established a sales organization, consisting of a
direct field sales management team and independent sales representatives, and a marketing
organization to market our products directly to our customers. By expanding our United States
presence, we intend to develop long-standing relationships with leading physicians treating
incontinence and overactive bladder symptoms. Outside of the United States, we sell our products
primarily through a direct and independent sales organization in the United Kingdom and primarily
through distributors in other markets.
Page 17
Critical Accounting Policies
We prepare our consolidated financial statements in accordance with U.S. generally accepted
accounting principles, which require us to make estimates and assumptions in certain circumstances
that affect amounts reported. In preparing these consolidated financial statements, we have made
our best estimates and judgments of certain amounts, giving due consideration to materiality. We
believe that of our significant accounting policies, the following are particularly important to
the portrayal of our results of operations and financial position. They may require the
application of a higher level of judgment by Uroplasty management, and as a result are subject to
an inherent degree of uncertainty.
Revenue Recognition. The Securities and Exchange Commissions Staff Accounting Bulletin (SAB) No.
104, Revenue Recognition in Financial Statements, provides guidance on the application of generally
accepted accounting principles to selected revenue recognition issues. We believe our revenue
recognition policies comply with SAB 104. We market and distribute our products primarily through
our direct and independent sales organization in the United States and the United Kingdom, and
primarily through distributors in our other markets. We recognize revenue upon shipment of product
to our distributors and direct customers. We have no customer acceptance provisions or
installation obligations. Our sales terms to our distributors and customers provide no right of
return outside of our standard warranty, and payment terms consistent with industry standards
apply. Sales terms and pricing to our distributors are governed by the respective distribution
agreements. Our distribution partners purchase the Uroplasty products to meet sales demand of
their end-user customers as well as to fulfill their internal requirements associated with the
sales process and, if applicable, contractual purchase requirements under the respective
distribution agreements. Internal and other requirements include purchases of products for
training, demonstration and evaluation purposes, clinical evaluations, product support,
establishing inventories, and meeting minimum purchase commitments. As a result, the level of our
net sales during any period is not necessarily indicative of our distributors sales to end-user
customers during that period, which we estimate are not substantially different than our sales to
those distributors in each of the last two years. Our distributors level of inventories of our
products, their sales to end-user customers and their internal product requirements may impact our
future revenue growth.
Accounts Receivable. We carry our accounts receivable at the original invoice amount less an
estimate made for doubtful receivables based on a periodic review of all outstanding amounts. We
determine the allowance for doubtful accounts based on customer health, and both historical and
expected credit loss experience. We write off our accounts receivable when we deem them
uncollectible. We record recoveries of accounts receivable previously written off when received.
Inventories. We state inventories at the lower of cost or market using the first-in, first-out
method. We provide lower of cost or market reserves for slow moving and obsolete inventories based
upon current and expected future product sales and the expected impact of product transitions or
modifications. While we expect our sales to grow, a reduction in sales could reduce the demand for
our products and may require additional inventory reserves.
Foreign Currency Translation/Transactions. The financial statements of our foreign
subsidiaries were translated in accordance with the provisions of SFAS No. 52, Foreign Currency
Translation. Under this Statement, we translate all assets and liabilities using period-end
exchange rates, and we translate statements of operations items using average exchange rates for
the period. We record the resulting translation adjustment within accumulated other comprehensive
loss, a separate component of shareholders equity. We recognize foreign currency transaction
gains and losses in the statement of operations, including unrealized gains and losses on
short-term intercompany obligations using period-end exchange rates, resulting in an increase in
the volatility of our consolidated statements of operations. We recognize unrealized gains and
losses on long-term intercompany obligations within accumulated other comprehensive loss, a
separate component of shareholders equity.
Impairment of Long-Lived Assets. Long-lived assets at December 31, 2006 consist of property, plant
and equipment and intangible assets. We review our long-lived assets for impairment whenever events
or business circumstances indicate that the carrying amount of an asset may not be recoverable. We
measure the recoverability of assets to be held and used by a comparison of the carrying amount of
an asset to future undiscounted net cash flows expected to be generated by the asset. If we
consider such assets impaired, we measure the impairment to be recognized by the amount by which
the carrying amount of the assets exceeds the fair value of the assets. We report assets to be
disposed of at the lower of the carrying amount or fair value less costs to sell.
Share-Based Compensation. FASB published Statement No. 123 (revised 2004), Share-Based Payment
(SFAS 123(R) or the Statement). SFAS 123(R) requires that we recognize the compensation cost
relating to share-based payment transactions, including grants of employee stock options, in our
financial statements. We must measure that cost based on the fair value of the equity or liability
instruments issued. SFAS 123(R) covers a wide range of share-based compensation
Page 18
arrangements including stock options, restricted share plans, performance-based awards, share
appreciation rights, and employee share purchase plans. SFAS 123(R) is a replacement of Statement
No. 123, Accounting for Stock-Based Compensation, and supersedes APB 25, and its related
interpretive guidance.
This Statement requires us to measure the cost of employee services received in exchange for stock
options based on the grant-date fair value of the award, and to recognize the cost over the period
we require our employee to provide services for the award. We adopted SFAS 123(R) for the first
time beginning April 1, 2006, under the modified prospective transition method. We calculated the
pro forma compensation costs presented previously and in our prior filings using a Black-Scholes
option pricing model. These compensation costs may not be indicative of amounts which we will
incur in future years.
Income Taxes. We recognize deferred tax assets and liabilities for future tax consequences
attributable to differences between the financial carrying amounts of existing assets and
liabilities and their respective tax bases. We measure deferred tax assets and liabilities using
enacted tax rates we expect to apply to taxable income in the years in which we expect to recover
or settle those temporary differences. As of December 31, 2006, we have generated approximately
$15,423,000 in U.S. net operating loss carryforwards that we cannot use to offset taxable income in
foreign jurisdictions. We recognize a valuation allowance when we determine it is more likely than
not that we will not realize a portion of the deferred tax asset. We have established a valuation
allowance for U.S. and certain foreign deferred tax assets due to the uncertainty that we will
generate enough income in those taxing jurisdictions to utilize the assets.
In addition, U.S. tax rules impose limitations on the use of net operating loss following certain
changes in ownership. Such a change in ownership may limit the amount of these benefits that would
be available to offset future taxable income each year, starting with the year of ownership change.
Set forth below is managements discussion and analysis of the financial condition and results of
operations for the three and nine-months ended December 31, 2006 and 2005.
Results of Operations
Three months ended December 31, 2006 compared to three months ended December 31, 2005
Net Sales: During the three months ended December 31, 2006, net sales were $2.2 million,
representing a $566,000 or a 36% increase compared to net sales of $1.6 million for the three
months ended December 31, 2005. Excluding the impact of fluctuations in foreign currency exchange
rates, sales increased by approximately 29%. Sales of our Urgent PC product more than offset the
4% decline in sales of our Macroplastique products. During the three months ended December 31,
2005, we had minimal sales of the Urgent PC.
We attribute the decline in sales of the Macroplastique products primarily due to adverse changes
in the implementation of reimbursement policies by the governments in countries outside the U.S.,
and the increase in pricing competition. We expect this to adversely impact our future sales in
those markets. In response, we have implemented targeted volume price reductions, have increased
the number of training workshops targeted to our distributors and key incontinence surgeons, and
are sponsoring scientific podium presentations and seminars at the most highly recognized
international incontinence congresses. We cannot assure that these initiatives will increase
Macroplastique sales.
Sales to customers in the U.S. during the three months ended December 31, 2006 increased to
$396,000 from $62,000 in the same quarter of 2005. Sales for the three months ended December 31,
2006 represent a sequential increase from $253,000 in the previous quarter. We attribute the sales
increase to our U.S. sales organization which we fully established during the quarter ended
December 31, 2006. During 2006, we sold only the Urgent PC and the I-Stop to customers in the U.S.
Gross Profit: Gross profit was $1.4 million and $1.2 million for the three months ended December
31, 2006 and 2005, respectively, or 65% and 75% of net sales in the respective periods. In the
third quarter of fiscal 2007, we incurred $107,000 of charges related to rework, scrap and warranty
for one of our new products. Also, in the U.S. we incurred charges in the third quarter of fiscal
2007 to facilitate relocation of our manufacturing operations (including charges to duplicate our
manufacturing facilities prior to the move). In addition, manufacturing capacity utilization
declined in the third quarter of fiscal 2007, as we had stepped up production during the previous
quarter to meet our product needs during the manufacturing facility transition period. We
anticipate FDA qualification of our new manufacturing operations in the U.S. in the second half of
2007.
Page 19
General and Administrative Expenses (G&A): G&A expenses decreased from $859,000 during the three
months ended December 31, 2005 to $732,000 during the same period in 2006. Included in the 2006
period is a $127,000 non-cash, SFAS
123(R) charge for share-based employee compensation. Excluding this charge, G&A expenses declined
by $254,000, primarily because of a decrease in personnel-related costs. Further, during the three
months ended December 31, 2005, we incurred certain charges to install our new information system.
Research and Development Expenses (R&D): R&D expenses decreased from $700,000 during the three
months ended December 31, 2005 to $425,000 during the same period in 2006. Included in the 2006
period is a $4,000 non-cash, SFAS 123(R) charge for share-based employee compensation. We
attribute the decrease to reduced consulting expense of $330,000. During the three months ended
December 31, 2005, we incurred consulting expense primarily for the development of our second
generation Urgent PC product.
Selling and Marketing Expenses (S&M): S&M expenses increased from $852,000 during the three months
ended December 31, 2005 to $1.3 million during the same period in 2006. Included in the 2006
period is a $10,000 non-cash, SFAS 123(R) charge for share-based employee compensation. We
attribute the increase to the $130,000 increase in compensation-related costs, primarily for our
U.S. direct sales force and marketing organization, the $110,000 increase in commissions for sales
agents and independent sales representatives, the $60,000 increase in travel-related costs, the
$30,000 increase in promotional activities and an increase in other costs to support our expanded
sales organization and marketing activities.
Other Income (Expense): Other income (expense) includes interest income, interest expense, warrant
benefit, foreign currency exchange gains and losses and other non-operating costs when incurred.
Our financial results are subject to material fluctuations based on changes in currency exchange
rates. Other income was $535,000 and $593,000 for the three months ended December 31, 2006 and
2005, respectively.
As a result of the suspension of the exercise of the 706,218 warrants we originally issued in July
2002, we granted a like number of new common stock purchase warrants to the holders of the expired
warrants in April 2005. The U.S. Securities and Exchange Commission declared the registration
statement for these warrants effective on December 19, 2006. The new warrants are exercisable at
$2.00 per share at any time up to March 19, 2007. In April 2005, we recognized a liability and a
charge to equity of approximately $1.4 million associated with the grant of these new warrants. We
determined the fair value of these warrants using the Black-Scholes option-pricing model. We have
since reduced the reported liability to $515,000 due to the decrease in the fair value of these
warrants from their date of issuance through December 31, 2006. We recorded a warrant benefit of
$523,000 and $560,000 for the three months ended December 31, 2006 and 2005 , respectively.
We recognize exchange gains and losses primarily as a result of fluctuations in currency rates
between the U.S. dollar (the functional reporting currency) and the euro and British pound
(currencies of our subsidiaries), as well as their effect on the dollar denominated short-term
intercompany obligations between us and our foreign subsidiaries. We recognized foreign currency
gains (losses) of $4,000 and $(7,000) for the three months ended December 31, 2006 and 2005,
respectively.
Income Tax Expense: Our Dutch subsidiaries recorded income tax expense of $45,000 and $40,000 for
the three months ended December 31, 2006 and 2005, respectively. For fiscal 2007, the Dutch income
tax rate is 25.5% for 22,689 (approximately $29,000) of profit and 29.6% for amounts above 22,689
compared to 27% and 31.5% in fiscal 2006, respectively.
Nine months ended December 31, 2006 compared to nine months ended December 31, 2005
Net Sales: During the nine months ended December 31, 2006, net sales were $5.7 million,
representing a $890,000 or a 19% increase when compared to net sales of $4.8 million for the nine
months ended December 31, 2005. Excluding the impact of fluctuations in foreign currency exchange
rates, sales increased by approximately 14%. Sales of our Urgent PC product, and an increase in
sales of the I-Stop product, more than offset the 9% decline in sales of Macroplastique products.
During the nine months ended December 31, 2005, we had minimal sales of the Urgent PC and the
I-Stop products.
We attribute the decline in sales of the Macroplastique products primarily due to adverse changes
in the implementation of reimbursement policies by the governments in countries outside the U.S.,
and the increase in pricing competition. We expect this to adversely impact our future sales in
those markets. In response, we have implemented targeted volume price reductions, have increased
the number of training workshops targeted to our distributors and key incontinence surgeons, and
are sponsoring scientific podium presentations and seminars at the most highly recognized
international incontinence congresses. We cannot assure that these initiatives will increase
Macroplastique sales.
Sales to customers in the U.S. during the nine months ended December 31, 2006 increased to $752,000
from $63,000 in the for the same period in 2005. For the nine months ended December 31, 2006,
sales to customers in the U.S. accounted for approximately 13 percent of our consolidated sales, up
from one percent for the same period in 2005. We attribute the sales
increase to our U.S. sales organization which we fully established during the quarter ended
December 31, 2006. During 2006, we sold only the Urgent PC and the I-Stop to customers in the U.S.
Page 20
Gross Profit: Gross profit was $3.9 million and $3.5 million for the nine months ended December
31, 2006 and 2005, respectively, or 69% and 73% of net sales in the respective periods. In the
third quarter of fiscal 2007, we incurred $107,000 of charges related to rework, scrap and warranty
for one of our new products. Also, in the U.S. we incurred charges in the third quarter of fiscal
2007 to facilitate relocation of our manufacturing operations (including charges to duplicate our
manufacturing facilities prior to the move). We anticipate FDA qualification of our new
manufacturing operations in the U.S. in the second half of 2007.
General and Administrative Expenses (G&A): G&A expenses increased from $2.3 million during the
nine months ended December 31, 2005 to $2.4 million during the same period in 2006. Included in
the 2006 period is a $519,000 non-cash, SFAS 123(R) charge for share-based employee compensation.
Excluding this charge, G&A expenses in the 2006 period declined by $370,000, in part due to a
$180,000 decrease in personnel-related costs, offset by increased rent expense. In addition,
during the nine months ended December 31, 2005, we incurred $160,000 of charges to install our new
information system and for AMEX listing fees, offset by a $145,000 reversal of bad debt expense.
Research and Development Expenses (R&D): R&D expenses decreased from $2.4 million during the nine
months ended December 31, 2005 to $1.8 million during the same period in 2006. Included in the 2006
period is a $21,000 non-cash, SFAS 123(R) charge for share-based employee compensation. We
attribute the decrease to the $290,000 decrease for personnel-related costs and the $450,000
decrease for consulting expense, offset by the $130,000 increase in clinical costs for ongoing
post-market clinical studies for our PTQ product and for comparing the efficacy of the Urgent PC
against a leading drug therapy for treatment of overactive bladder symptoms. During the nine
months ended December 31, 2005, we incurred consulting expense primarily for the development of our
second generation Urgent PC product and a $205,000 expense related to severance compensation for
our former Vice President of Research and Development and Managing Director of our United Kingdom
subsidiary.
Selling and Marketing Expenses (S&M): S&M expenses increased from $2.3 million during the nine
months ended December 31, 2005 to $3.8 million during the same period in 2006. Included in the
2006 period is a $46,000 non-cash, SFAS 123(R) charge for share-based employee compensation. We
attribute the increase to the $720,000 increase in compensation-related costs, primarily for our
U.S. direct sales force and marketing organization, the $200,000 increase in commissions for sales
agents and independent sales representatives, the $290,000 increase in travel-related costs and an
increase in other costs to support our expanded organization and marketing activities.
Other Income (Expense): Other income (expense) includes interest income, interest expense, warrant
expense or benefit, foreign currency exchange gains and losses and other non-operating costs when
incurred. Our financial results are subject to material fluctuations based on changes in currency
exchange rates. Other income was $217,000 and $646,000 for the nine months ended December 31, 2006
and 2005, respectively.
As a result of the suspension of the exercise of the 706,218 warrants we originally issued in July
2002, we granted a like number of new common stock purchase warrants to the holders of the expired
warrants in April 2005. The U.S. Securities and Exchange Commission declared the registration
statement for these warrants effective on December 19, 2006. The new warrants are exercisable at
$2.00 per share at any time up to March 19, 2007. In April 2005, we recognized a liability and a
charge to equity of approximately $1.4 million associated with the grant of these new warrants. We
determined the fair value of these warrants using the Black-Scholes option-pricing model. We have
since reduced the reported liability to $515,000 due to the decrease in the fair value of these
warrants from their date of issuance through December 31, 2006. We recorded a warrant benefit of
$150,000 and 575,000 for the nine months ended December 31, 2006 and 2005, respectively.
We recognize exchange gains and losses primarily as a result of fluctuations in currency rates
between the U.S. dollar (the functional reporting currency) and the euro and British pound
(currencies of our subsidiaries), as well as their effect on the dollar denominated short-term
intercompany obligations between us and our foreign subsidiaries. We recognized foreign currency
gains (losses) of $34,000 and $(16,000) for the nine-months ended December 31, 2006 and 2005,
respectively.
Income Tax Expense: Our Dutch subsidiaries recorded income tax expense of $63,000 and $43,000 for
the nine months ended December 31, 2006 and 2005, respectively. For fiscal 2007, the Dutch income
tax rate is 25.5% for 22,689 (approximately $29,000) of profit and 29.6% for amounts above 22,689
compared to 27% and 31.5% in fiscal 2006, respectively.
Page 21
Non-GAAP Financial Measures. In addition to disclosing the financial results for the three and
nine months ended December 31, 2006 calculated in accordance with U.S. generally accepted
accounting principles (GAAP), our discussion of the results of operations above contains non-GAAP
financial measures that exclude the effects of share-based employee compensation under the
requirements of FAS 123(R). The non-GAAP financial measures used by management and disclosed by us
exclude the income statement effects of share-based employee compensation under the requirements of
FAS 123(R). The non-GAAP financial measures disclosed by us should not be considered a substitute
for, or superior to, financial measures calculated in accordance with GAAP, and the consolidated
financial results calculated in accordance with GAAP and reconciliations to those financial
statements should be carefully evaluated. We may calculate our non-GAAP financial measures
differently from similarly titled measures used by other companies. Therefore, our non-GAAP
financial measures may not be comparable to those used by other companies. We have described the
reconciliations of each of our non-GAAP financial measures above to the most directly comparable
GAAP financial measures.
Because we excluded FAS 123(R) share-based employee compensation expense in some of our discussion
above, these financial measures are treated as a non-GAAP financial measure under Securities and
Exchange Commission rules. Management uses our non-GAAP financial measures for internal managerial
purposes, including as a means to compare period-to-period results on a consolidated basis and as a
means to evaluate our results on a consolidated basis compared to those of other companies.
We disclose this information to the public to enable investors who wish to more easily assess our
performance on the same basis applied by management and to ease comparison on both a GAAP and
non-GAAP basis among peer companies.
Liquidity and Capital Resources
Cash Flows. As of December 31, 2006, our cash and cash equivalents balances totaled $5.7 million.
At December 31, 2006, we had working capital of approximately $6.1 million. For the nine months
ended December 31, 2006, we used $3.0 million of cash in operating activities, compared to $1.8
million of cash used in the same period a year ago. We attribute the increase in the use of cash
for operating activities primarily to the increase in loss and investment in working capital.
Sources of Liquidity. In April 2005, we conducted a private placement in which we sold 2,147,142
shares of our common stock at a price per share of $3.50, together with warrants to purchase
1,180,928 shares of our common stock, for an aggregate purchase price of approximately $7.5
million. The stock sale proceeds are offset by costs of approximately $935,000, resulting in net
proceeds of approximately $6.6 million. The warrants are exercisable for five years at an exercise
price of $4.75 per share.
In May 2006, we also entered into a $100,000 3-year, term loan agreement with Venture Bank, at an
interest rate of 8.25% per annum. We used these proceeds for certain capital expenditures relating
to the relocation of our facility to our Minnetonka, Minnesota location.
In August 2006, we entered into a securities purchase agreement with certain investors pursuant to
which we sold approximately 1.4 million shares of our common stock for $1.50 per share, together
with warrants to purchase 695,000 shares of our common stock, for an aggregate purchase price of
approximately $2.1 million. After offset for our estimated costs of $183,000, we received net
proceeds of approximately $1.9 million. The warrants are exercisable for five years (but
commencing 181 days after closing) at an exercise price of $2.50 per share.
In October 2006, we amended our business loan agreement with Venture Bank. The amended agreement
provides for a credit line of up to $500,000 secured by our assets and will expire in April 2007 if
not renewed. We may borrow up to 50% of the value of the inventory on hand in the U.S. and 75% of
the U.S. accounts receivable value. The bank charges interest on the loan at the rate of 1
percentage point over the prime rate (8.25% on December 31, 2006), subject to a minimum interest
rate of 7% per annum. In addition, Uroplasty BV, our subsidiary, entered into an arrangement with
Rabobank of The Netherlands for a 200,000 (approximately $264,000) credit line. At December 31,
2006, we had no borrowings under any of our credit lines.
In December 2006, we conducted a follow-on public offering in which we sold 2,430,000 shares of our
common stock at a price per share of $2.00, for an aggregate purchase price of approximately $4.9
million. The stock sale proceeds are offset by costs of approximately $564,000, resulting in net
proceeds of approximately $4.3 million.
Page 22
Because we have yet to achieve profitability and generate positive cash flows, we will need to
raise additional debt or equity financing to continue funding for product development, continued
expansion of our sales and marketing activities and planned growth activities beyond fiscal 2008.
There can be no guarantee that we will be successful, as we currently have no committed sources of,
or other arrangements with respect to, additional equity or debt financing.
We therefore cannot ensure that we will obtain additional financing on
acceptable terms, or at all. If we are unable to raise the needed funds, we will need to curtail
our operations including product development, clinical studies and sales and marketing activities.
This would adversely impact our future business and prospects. Ultimately, we will need to achieve
profitability and generate positive cash flows from operations to fund our operations and grow our
business.
For the balance of fiscal 2007, we expect to incur additional research and development expenses,
including those in connection with clinical trials for the Urgent PC and FDA-required post-approval
studies to obtain market feedback on safety and effectiveness of Macroplastique. We also expect
that during the balance of fiscal 2007, we will continue to incur significant expenses as we fund
our selling and marketing organization in the U.S. to market our products.
In April 2005, we entered into an exclusive manufacturing and distribution agreement with
CystoMedix for the Urgent PC product. The agreement required us to pay CystoMedix an initial
payment of $225,000 and an additional payment of $250,000 in 12 monthly installments of $20,833,
with the last installment payment made in the first quarter of fiscal 2007. We capitalized the
aggregate amount as licensed technology and are amortizing it over the term of the agreement. We
will also pay CystoMedix a 7% royalty on product sales. However, the 7% royalty is first offset
against the monthly royalty installments. Currently we do not project making any additional
royalty payments to CystoMedix in fiscal 2007.
CystoMedix has also granted us an exclusive option to acquire its assets. The purchase price is
$3,485,000, reduced by up to $50,000 of liabilities assumed by us. However, the $3,485,000 amount
used to compute the purchase price will increase at a rate of 10% per year after April 2007. The
purchase price is payable in shares of our common stock valued at the average of the closing bid
price of our shares for the 20 trading days prior to our exercise of the option. We may exercise
the option until June 2008. If we exercise the option, we will also assume up to $1.4 million of
bridge loan advances made to CystoMedix by its Chairman. We would repay up to $1.1 million of the
bridge loan advances at closing and would issue our common stock for the balance of the bridge loan
based on the above option price. We also have certain rights of first refusal to acquire
CystoMedixs assets in the event CystoMedix receives a third party offer in advance of any exercise
of our option. We will need to raise additional equity or debt funds in order to consummate the
CystoMedix acquisition, should we elect to do so.
We have two exclusive distribution agreements with CL Medical allowing us to market and sell the
I-Stop urethral sling: effective February 2006, a six-year agreement, with a right to renew it for
successive five-year terms, for distribution in the United States and, effective May 2005, a
one-year agreement with automatic renewal for up to two years, for distribution in the United
Kingdom. Under the agreements, we are required to purchase a minimum of $527,000 of units in the
first 12-month period following January 1, 2006, increasing to $2.9 million of units in the fifth
year of the agreement, for an aggregate commitment of approximately $6.6 million of units over the
remaining agreement period, subject to periodic adjustment based on the value of the euro.
We were obligated to pay royalties of 5% of net sales of Macroplastique products in the U.S. with a
minimum of $50,000 per year. This royalty agreement expired on May 1, 2006. Under another royalty
agreement we pay royalties, in the aggregate, of three to five percent of net sales of
Macroplastique, Bioplastique, and PTQ Implants subject to a monthly minimum of $4,500. The
royalties payable under this agreement will continue until the patent referenced in the agreement
expires in 2010. Under a license agreement for the Macroplastique Implantation System, we pay a
royalty of 10 British pounds for each unit sold during the life of the patent.
We have a pension plan covering 14 employees in The Netherlands, reported as a defined benefit
plan. We pay premiums to an insurance company to fund annuities for these employees. However, we
are responsible for funding additional annuities based on continued service and future salary
increases. We closed this defined benefit plan for new employees in April 2005. As of that date,
the Dutch subsidiary established a defined contribution plan that now covers new employees. We also
closed our UK subsidiarys defined benefit plan to further accrual for all employees effective
December 31, 2004. In March 2005, the UK subsidiary established a defined contribution plan that
now covers new employees. As of December 31, 2006, we had an accrued pension liability of $742,000.
In January 2006, we entered into a long-term lease with Liberty Property Limited Partnership for an
18,258 square foot facility for our U.S. headquarters located at 5420 Feltl Road, Minnetonka,
Minnesota. The lease effective date was May 1,
2006, has a term of 96 months, requires average annual minimum rent payments of approximately
$140,000 and requires payments for operating expenses estimated to be approximately $82,000 in the
first 12 months.
Page 23
Repayments of our contractual obligations as of December 31, 2006, consisting of royalties, notes
payable (inclusive of interest), and operating leases, are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Remainder |
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
|
|
|
|
|
of Fiscal |
|
|
2008 and |
|
|
2010 and |
|
|
2012 and |
|
|
|
Total |
|
|
2007 |
|
|
2009 |
|
|
2011 |
|
|
thereafter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Minimum royalty payments |
|
$ |
207,000 |
|
|
$ |
13,500 |
|
|
$ |
108,000 |
|
|
$ |
85,500 |
|
|
$ |
|
|
Minimum purchase agreement |
|
|
6,616,050 |
|
|
|
148,534 |
|
|
|
2,189,744 |
|
|
|
4,277,772 |
|
|
|
|
|
Notes payable, including
interest |
|
|
632,777 |
|
|
|
25,828 |
|
|
|
197,260 |
|
|
|
111,127 |
|
|
|
298,562 |
|
Operating lease commitments |
|
|
1,408,927 |
|
|
|
65,611 |
|
|
|
481,429 |
|
|
|
371,396 |
|
|
|
490,491 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
8,864,754 |
|
|
$ |
253,473 |
|
|
$ |
2,976,433 |
|
|
$ |
4,845,795 |
|
|
$ |
789,053 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITEM 3. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls Procedures. Within the 90 days prior to the date of this report,
our President and Chief Executive Officer and Chief Financial Officer carried out an evaluation of
the effectiveness of the design and operation of our disclosure controls and procedures pursuant to
Rule 13a-15b under the Securities Exchange Act of 1934. Based on this evaluation, these officers
concluded that, as of the end of the period covered by this report, our disclosure controls and
procedures are effective to ensure that information required to be disclosed by us in the reports
we file or submit under the Exchange Act is accumulated and communicated to our management,
including such officers, to allow timely decisions regarding disclosure, and is recorded,
processed, summarized and reported within the time periods specified in Securities and Exchange
Commission rules and forms.
Internal Control Matters. We also maintain a system of internal accounting controls designed to
provide reasonable assurance that our books and records accurately reflect our transactions and
that our policies and procedures are followed. There have been no changes in our internal control
over financial reporting during the three months ended December 31, 2006, or thereafter, that have
materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
Any control system, no matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system are met. The design of a control
system inherently has limitations, and the benefits of controls must be weighed against their
costs. Additionally, controls can be circumvented by the individual acts of some persons, by
collusion of two or more people, or by management override of the control. Therefore, no
evaluation of a cost-effective system of controls can provide absolute assurance that all control
issues and instances of fraud, if any, will be detected.
Page 24
PART II. OTHER INFORMATION
Except as indicated below, none of the items contained in PART II of Form 10-QSB are applicable to
us for the three months ended December 31, 2006.
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 6. EXHIBITS.
(a) Exhibits
31.1 Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
32.1 Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (this Exhibit is furnished pursuant to SEC rules,
but is deemed not filed)
Page 25
SIGNATURES
In accordance with the requirements of the Securities Exchange Act of 1934, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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UROPLASTY, INC.
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Date: February 12, 2007 |
By: |
/s/ DAVID B. KAYSEN
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David B. Kaysen |
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President and Chief Executive Officer |
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Date: February 12, 2007 |
By: |
/s/ MAHEDI A. JIWANI
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Mahedi A. Jiwani |
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Chief Financial Officer |
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Exhibit 31.1
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, David B. Kaysen, certify that:
1. I have reviewed this report on Form 10-QSB for the quarterly period ended December 31, 2006 of
Uroplasty, Inc. (the Small Business Issuer);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the Small Business Issuer as of, and for, the periods presented in this report;
4. The Small Business Issuers other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the Small Business Issuer and have:
(a) designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information relating to
the Small Business Issuer, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
(b) evaluated the effectiveness of the Small Business Issuers disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report, based on such evaluation; and
(c) disclosed in this report any change in the Small Business Issuers internal control over
financial reporting that occurred during the Small Business Issuers most recent fiscal quarter
(the Small Business Issuers fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the Small Business Issuers
internal control over financial reporting; and
5. The Small Business Issuers other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the Small Business Issuers
auditors and the audit committee of the Small Business Issuers board of directors (or persons
performing the equivalent functions):
(a) all significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the Small Business
Issuers ability to record, process, summarize and report financial information; and
(b) any fraud, whether or not material, that involves management or other employees who have a
significant role in the Small Business Issuers internal control over financial reporting.
Date: February 12, 2007
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By |
/s/ DAVID B. KAYSEN
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David B. Kaysen, President and Chief Executive Officer |
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CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Mahedi A. Jiwani, certify that:
1. I have reviewed this report on Form 10-QSB for the quarterly period ended December 31, 2006 of
Uroplasty, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the Small Business Issuer as of, and for, the periods presented in this report;
4. The Small Business Issuers other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the small business issuer and have:
(a) designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information relating to
the Small Business Issuer, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
(b) evaluated the effectiveness of the Small Business Issuers disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report, based on such evaluation; and
(c) disclosed in this report any change in the Small Business Issuers internal control over
financial reporting that occurred during the Small Business Issuers most recent fiscal quarter
(the Small Business Issuers fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the Small Business Issuers
internal control over financial reporting; and
5. The Small Business Issuers other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the small business issuers
auditors and the audit committee of the Small Business Issuers board of directors (or persons
performing the equivalent functions):
(a) all significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the Small Business
Issuers ability to record, process, summarize and report financial information; and
(b) any fraud, whether or not material, that involves management or other employees who have a
significant role in the Small Business Issuers internal control over financial reporting.
Date: February 12, 2007
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By |
/s/ MAHEDI A. JIWANI
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Mahedi A. Jiwani, Chief Financial Officer |
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Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Uroplasty, Inc. (the Company) on Form 10-QSB for the
quarterly period ended December 31, 2006 as filed with the Securities and Exchange Commission on
the date hereof (the Report), I, David B. Kaysen, President and Chief Executive Officer of the
Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley
Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities
Exchange Act of 1934 and
(2) The information contained in the Report fairly presents, in all material respects, the
financial condition and result of operations of the Company.
/s/ DAVID B. KAYSEN
David B. Kaysen
Chief Executive Officer
Dated: February 12, 2007
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Uroplasty, Inc. (the Company) on Form 10-QSB for the
quarterly period ended December 31, 2006 as filed with the Securities and Exchange Commission on
the date hereof (the Report), I, Mahedi A. Jiwani, Chief Financial Officer of the Company,
certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of
2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities
Exchange Act of 1934 and
(2) The information contained in the Report fairly presents, in all material respects, the
financial condition and result of operations of the Company.
/s/ MAHEDI A. JIWANI
Mahedi A. Jiwani
Chief Financial Officer
Dated: February 12, 2007