e424b3
|
|
|
PROSPECTUS SUPPLEMENT NO. 10
(To Prospectus dated July 29, 2005)
|
|
Filed pursuant to Rule 424(b)(3)
Registration No. 333-126737 |
UROPLASTY, INC.
2,147,142 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. 10 together
with the prior prospectus supplements and prospectus dated July 29, 2005, which are to be delivered
with this prospectus supplement.
This prospectus supplement contains our Quarterly Report on Form 10-QSB for the quarter ended
December 31, 2005. This report was filed with the Securities and Exchange Commission on February
14, 2006. 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 13,
2006, the closing price of our common stock on the American Stock Exchange was $2.70 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 14, 2006
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, 2005
Commission File No. 000-20989
UROPLASTY, INC.
(Name of Small Business Issuer in its Charter)
|
|
|
Minnesota, U.S.A.
|
|
41-1719250 |
(State or other jurisdiction of
|
|
(I.R.S. Employer |
incorporation or organization)
|
|
Identification No.) |
2718 Summer Street NE
Minneapolis, Minnesota 55413-2820
(Address of principal executive offices)
(612) 378-1180
(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 February 1, 2006 was 6,880,405.
Transitional Small Business Disclosure Format:
YES o NO þ
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
UROPLASTY, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 |
|
|
March 31, 2005 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
2,532,823 |
|
|
$ |
1,492,684 |
|
Short-term investments |
|
|
1,526,214 |
|
|
|
|
|
Accounts receivable, net |
|
|
920,020 |
|
|
|
944,527 |
|
Inventories |
|
|
812,299 |
|
|
|
547,476 |
|
Income tax receivable |
|
|
123,744 |
|
|
|
114,189 |
|
Other |
|
|
174,723 |
|
|
|
161,920 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
6,089,823 |
|
|
|
3,260,796 |
|
|
|
|
|
|
|
|
|
|
Property, plant, and equipment, net |
|
|
1,032,196 |
|
|
|
1,040,253 |
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
371,878 |
|
|
|
39,100 |
|
|
|
|
|
|
|
|
|
|
Deferred tax assets |
|
|
88,984 |
|
|
|
103,075 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
7,582,881 |
|
|
$ |
4,443,224 |
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the condensed interim consolidated financial statements. |
Page 2
UROPLASTY, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 |
|
|
March 31, 2005 |
|
|
|
(unaudited) |
|
|
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Current maturities long-term debt |
|
$ |
40,721 |
|
|
$ |
44,606 |
|
Accounts payable |
|
|
383,485 |
|
|
|
362,994 |
|
Accrued liabilities |
|
|
717,994 |
|
|
|
478,682 |
|
Warrant liability |
|
|
797,205 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
1,939,405 |
|
|
|
886,282 |
|
|
|
|
|
|
|
|
|
|
Long-term debt less current maturities |
|
|
390,665 |
|
|
|
461,265 |
|
Accrued pension liability |
|
|
264,486 |
|
|
|
303,781 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
2,594,556 |
|
|
|
1,651,328 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Common stock $.01 par value;
20,000,000 shares authorized,
6,880,405 and 4,699,597 shares issued
and outstanding at December 31 and
March 31, 2005, respectively |
|
|
68,804 |
|
|
|
46,996 |
|
Additional paid-in capital |
|
|
14,655,492 |
|
|
|
9,366,644 |
|
Accumulated deficit |
|
|
(9,347,146 |
) |
|
|
(6,491,387 |
) |
Accumulated other comprehensive loss |
|
|
(388,825 |
) |
|
|
(130,357 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
4,988,325 |
|
|
|
2,791,896 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
7,582,881 |
|
|
$ |
4,443,224 |
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the condensed interim consolidated financial statements. |
Page 3
UROPLASTY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Net sales |
|
$ |
1,592,526 |
|
|
$ |
1,609,692 |
|
|
$ |
4,793,134 |
|
|
$ |
5,012,912 |
|
Cost of goods sold |
|
|
391,163 |
|
|
|
383,573 |
|
|
|
1,274,308 |
|
|
|
1,317,303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
1,201,363 |
|
|
|
1,226,119 |
|
|
|
3,518,826 |
|
|
|
3,695,609 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
859,321 |
|
|
|
504,390 |
|
|
|
2,294,752 |
|
|
|
1,403,762 |
|
Research and development |
|
|
700,203 |
|
|
|
558,719 |
|
|
|
2,361,609 |
|
|
|
1,724,488 |
|
Selling and marketing |
|
|
852,483 |
|
|
|
416,886 |
|
|
|
2,321,122 |
|
|
|
1,535,642 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,412,007 |
|
|
|
1,479,995 |
|
|
|
6,977,483 |
|
|
|
4,663,892 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(1,210,644 |
) |
|
|
(253,876 |
) |
|
|
(3,458,657 |
) |
|
|
(968,283 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant benefit |
|
|
560,048 |
|
|
|
|
|
|
|
575,471 |
|
|
|
|
|
Interest income |
|
|
52,511 |
|
|
|
8,015 |
|
|
|
107,507 |
|
|
|
23,093 |
|
Interest expense |
|
|
(12,767 |
) |
|
|
(5,361 |
) |
|
|
(22,091 |
) |
|
|
(15,682 |
) |
Foreign currency exchange loss |
|
|
(7,374 |
) |
|
|
(6,478 |
) |
|
|
(15,779 |
) |
|
|
(20,564 |
) |
Other |
|
|
438 |
|
|
|
|
|
|
|
438 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
592,856 |
|
|
|
(3,824 |
) |
|
|
645,546 |
|
|
|
(13,153 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(617,788 |
) |
|
|
(257,700 |
) |
|
|
(2,813,111 |
) |
|
|
(981,436 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
39,942 |
|
|
|
86,311 |
|
|
|
42,648 |
|
|
|
138,540 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(657,730 |
) |
|
$ |
(344,011 |
) |
|
$ |
(2,855,759 |
) |
|
$ |
(1,119,976 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share |
|
$ |
(0.10 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
6,878,251 |
|
|
|
4,670,522 |
|
|
|
6,695,674 |
|
|
|
4,638,628 |
|
|
|
|
|
|
See accompanying notes to the condensed interim consolidated financial statements. |
Page 4
UROPLASTY,
INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF SHAREHOLDERS EQUITY AND COMPREHENSIVE LOSS
Nine months ended December 31, 2005
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Shareholders |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Loss |
|
|
Equity |
|
Balance at March 31, 2005 |
|
|
4,699,597 |
|
|
$ |
46,996 |
|
|
$ |
9,366,644 |
|
|
$ |
(6,491,387 |
) |
|
$ |
(130,357 |
) |
|
$ |
2,791,896 |
|
Proceeds from Private
Placement |
|
|
2,147,142 |
|
|
|
21,471 |
|
|
|
7,493,526 |
|
|
|
|
|
|
|
|
|
|
|
7,514,997 |
|
Costs of Private Placement |
|
|
|
|
|
|
|
|
|
|
(856,040 |
) |
|
|
|
|
|
|
|
|
|
|
(856,040 |
) |
Reissuance of Warrants |
|
|
|
|
|
|
|
|
|
|
(1,372,676 |
) |
|
|
|
|
|
|
|
|
|
|
(1,372,676 |
) |
Warrant registration costs |
|
|
|
|
|
|
|
|
|
|
(21,324 |
) |
|
|
|
|
|
|
|
|
|
|
(21,324 |
) |
Exercise of Stock Options |
|
|
33,666 |
|
|
|
337 |
|
|
|
45,362 |
|
|
|
|
|
|
|
|
|
|
|
45,699 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,855,759 |
) |
|
|
|
|
|
|
(2,855,759 |
) |
Translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(264,181 |
) |
|
|
(264,181 |
) |
Additional pension
liability |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,713 |
|
|
|
5,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,114,227 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2005 |
|
|
6,880,405 |
|
|
$ |
68,804 |
|
|
$ |
14,655,492 |
|
|
$ |
(9,347,146 |
) |
|
$ |
(388,825 |
) |
|
$ |
4,988,325 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the condensed interim consolidated financial statements.
Page 5
UROPLASTY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
Nine Months Ended December 31, 2005 and 2004
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,855,759 |
) |
|
$ |
(1,119,976 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
178,130 |
|
|
|
122,869 |
|
Loss on disposal of assets |
|
|
478 |
|
|
|
3,987 |
|
Warrant benefit |
|
|
(575,471 |
) |
|
|
|
|
Deferred tax assets |
|
|
4,420 |
|
|
|
(19,053 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(58,490 |
) |
|
|
(18,397 |
) |
Inventories |
|
|
(353,351 |
) |
|
|
23,603 |
|
Other current assets and income tax receivable |
|
|
(57,414 |
) |
|
|
43,963 |
|
Accounts payable |
|
|
37,554 |
|
|
|
(3,734 |
) |
Accrued liabilities |
|
|
275,446 |
|
|
|
(76,513 |
) |
Accrued pension liability |
|
|
(12,581 |
) |
|
|
9,821 |
|
Additional pension liability |
|
|
|
|
|
|
(996 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(3,417,038 |
) |
|
|
(1,034,426 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Payments for property, plant and equipment |
|
|
(180,745 |
) |
|
|
(61,304 |
) |
Payments for intangible assets |
|
|
(391,667 |
) |
|
|
(7,277 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(572,412 |
) |
|
|
(68,581 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Repayment of long-term debt |
|
|
(31,535 |
) |
|
|
(32,032 |
) |
Net proceeds from issuance of common stock and warrants |
|
|
6,683,333 |
|
|
|
204,812 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
6,651,798 |
|
|
|
172,780 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
(95,995 |
) |
|
|
118,314 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
2,566,353 |
|
|
|
(811,913 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
1,492,684 |
|
|
|
2,697,670 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
4,059,037 |
|
|
$ |
1,885,757 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
14,253 |
|
|
$ |
16,583 |
|
Cash paid during the period for income taxes |
|
|
62,608 |
|
|
|
113,136 |
|
|
|
|
|
|
See accompanying notes to the condensed interim consolidated financial statements. |
Page 6
UROPLASTY, INC. AND SUBSIDIARIES
Notes to the Condensed Interim Consolidated Financial Statements
(Unaudited)
1. Basis of Presentation
We have prepared our condensed interim 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 interim consolidated 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, 2005.
The condensed interim consolidated financial statements presented herein as of December 31, 2005
and for the three and nine-month periods ended December 31, 2005 and 2004 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, inventories, foreign currency translation and transactions, and impairment of
long-lived assets, each of which is more fully described in our Annual Report on Form 10-KSB for
the year ended March 31, 2005. 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, 2005, and we have made no changes to these policies during fiscal 2006.
2. Nature of Business, Sales of Common Stock and Corporate Liquidity
The majority of our products are sold primarily outside of the United States. We received the
510(K) premarket clearance from the U.S. Food and Drug Administration (FDA) in August 2005 for our
I-STOP(TM) Mid-Urethral Sling, a biocompatible, tension-free sling used to treat female urinary
incontinence. In October 2005 we received the 510(K) premarket
clearance for our Urgent® PC
Neurostimulation System, a proprietary, minimally invasive nerve stimulation device designed for
office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and
urinary frequency. We have established a sales force in the United States to commercialize these
products and anticipate increasing our sales and marketing organization. We continue to pursue
regulatory approvals to market other products in the United States. The FDA approval process can
be costly, lengthy and uncertain.
In March 2005, we entered into a business loan agreement with Venture Bank, pursuant to which we
may borrow up to $500,000 on a revolving basis. All amounts which the bank advances to us are due
in March 2006, unless the bank renews the agreement. Amounts advanced to us accrue interest at a
variable rate of 1% in excess of the published prime rate in the Wall Street Journal, with a
minimum rate of 6% per annum. We are obligated to pay interest monthly on the outstanding
principal balance. Advances under this agreement are secured by substantially all our assets. At
both December 31, 2005 and March 31, 2005, we had no outstanding balance under the agreement.
In April 2005, we conducted a private placement of common stock in which we sold 2,147,142 shares
of our common stock, together with warrants to purchase 1,180,928 shares of common stock, at a
price per share of $3.50, for an aggregate purchase price of approximately $7.5 million. The stock
sale proceeds were offset by costs of approximately $856,000, resulting in net proceeds of
approximately $6.7 million. The warrants are exercisable for five years at an exercise price of
$4.75 per share.
In connection with our April 2005 private placement, we agreed to file a registration statement
with the SEC covering the resale of the shares (including those underlying the warrants) that we
sold. We also agreed that, for each month after May 21, 2005, that we failed to file this
registration statement, and for each month after July 20, 2005 that the SEC did not declare it
effective, we would pay liquidated damages at a rate of 1% of the aggregate investment. We filed
the registration statement on July 20, 2005 and the SEC declared it effective on July 29, 2005.
Accordingly, we owe approximately $173,000 of liquidated damages and interest to the investors,
which will continue to accrue interest at 10% per annum until paid. We have
Page 7
offered these investors our common stock in lieu of cash, but we cannot assure that all or any of
the investors will accept our offer. We recorded a liability in our financial statements beginning
in the first quarter of fiscal 2006 related to these liquidated damages.
We believe that our current
resources, funds generated from the sale of our products and the remaining proceeds received from the private placement completed
earlier this year will be adequate to meet our cash flow needs, including regulatory activities
associated with existing products, through the next 12 months.
Ultimately, we will need to raise additional debt or equity financing achieve
profitability and generate positive cash flows from operations to fund our operations and grow our business
beyond the next twelve months.
3. Short-term Investments
At December 31, 2005, short-term investments
consist of certificates of deposit that mature within the next twelve
months. Based on the short-term nature of these investments their cost approximates their fair
market value.
Page 8
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, 2005 |
|
|
March 31, 2005 |
|
Raw materials |
|
$ |
384,921 |
|
|
$ |
216,723 |
|
Work-in-process |
|
|
55,611 |
|
|
|
75,337 |
|
Finished goods |
|
|
426,382 |
|
|
|
299,992 |
|
Reserve |
|
|
(54,615 |
) |
|
|
(44,576 |
) |
|
|
|
|
|
|
|
|
|
$ |
812,299 |
|
|
$ |
547,476 |
|
|
|
|
|
|
|
|
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, 2005 |
|
|
|
Estimated Lives |
|
|
Gross Carrying |
|
|
Accumulated |
|
|
|
|
|
|
(Years) |
|
|
Amount |
|
|
Amortization |
|
|
Net value |
|
Licensed technology |
|
|
5 |
|
|
$ |
417,957 |
|
|
$ |
70,333 |
|
|
$ |
347,624 |
|
Patents and inventions |
|
|
6 |
|
|
|
237,900 |
|
|
|
213,646 |
|
|
|
24,254 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
|
|
|
|
$ |
655,857 |
|
|
|
283,979 |
|
|
$ |
371,878 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2005 |
|
Licensed technology |
|
|
5 |
|
|
$ |
26,290 |
|
|
$ |
19,718 |
|
|
$ |
6,572 |
|
Patents and inventions |
|
|
6 |
|
|
|
237,900 |
|
|
|
205,372 |
|
|
|
32,528 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
|
|
|
|
$ |
264,190 |
|
|
$ |
225,090 |
|
|
$ |
39,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated annual amortization for these assets for the fiscal years ended March 31, is as follows:
|
|
|
|
|
Remainder of fiscal 2006 |
|
$ |
20,000 |
|
2007 |
|
|
89,000 |
|
2008 |
|
|
86,000 |
|
2009 |
|
|
86,000 |
|
2010 |
|
|
84,000 |
|
Thereafter |
|
|
7,000 |
|
|
|
|
|
|
|
$ |
372,000 |
|
|
|
|
|
Page 9
6. 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, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Net loss |
|
$ |
(657,730 |
) |
|
$ |
(344,011 |
) |
|
$ |
(2,855,759 |
) |
|
$ |
(1,119,976 |
) |
Items of other comprehensive
income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
(49,309 |
) |
|
|
253,170 |
|
|
|
(264,181 |
) |
|
|
285,164 |
|
Additional pension liability |
|
|
1,101 |
|
|
|
(9,129 |
) |
|
|
5,713 |
|
|
|
(10,117 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(705,938 |
) |
|
$ |
(99,970 |
) |
|
$ |
(3,114,227 |
) |
|
$ |
(844,929 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
7. Options and Warrants
The following options and warrants outstanding at December 31, 2005 and 2004 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 months ended: |
|
|
|
|
|
|
|
December 31, 2005
|
|
|
3,764,139 |
|
|
$0.90 to $10.50 |
December 31, 2004
|
|
|
2,046,576 |
|
|
$0.90 to $10.50 |
|
|
|
|
|
|
|
For the nine months ended: |
|
|
|
|
|
|
December 31, 2005
|
|
|
|
3,764,139 |
|
|
$0.90 to $10.50 |
December 31, 2004
|
|
|
|
2,046,576 |
|
|
$0.90 to $10.50 |
8. Shareholders Equity
Warrants
As a result of our suspension of the exercise of the 706,218 warrants 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 new warrants will be exercisable at $2.00 per share for 90 days after
the effective date of a new registration statement covering the resale of the shares underlying
these warrants. We have filed a registration statement on Form SB-2 with the Securities and
Exchange Commission (SEC), expect to file an amendment to the registration statement in February
2006 covering the warrant shares, and anticipate the effectiveness of the registration statement to
be in March 2006, subject entirely to the action taken by the SEC on our registration statement.
In April 2005, we recognized a liability of $1.4 million associated with the grant of these new
warrants by a charge to paid-in capital. We have reported a year-to-date net warrant benefit of
approximately $575,000 due to the decrease, since April 2005, in the fair value of the common stock
which may be acquired by the exercise of these warrants.
Page 10
9. Stock-based Compensation
We apply the intrinsic-value method to account for employee stock-based compensation. As such,
compensation expense, if any, is recorded on the date of grant if the current market price of the
underlying stock exceeds the exercise price.
We account for stock-based instruments granted to non-employees under the fair value method of
Financial Accounting Standards Board (FASB) Statement No. 123 and Emerging Issues Task Force (EITF)
96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or
in Conjunction with Selling, Goods or Services. Under Statement
No. 123 we record options at their
fair value on the measurement date, which is typically the vesting date.
Had we determined compensation cost based on the fair value at the grant date for our stock options
issued to employees under SFAS 123, Accounting for Stock-Based Compensation, our net loss and per
common share amounts would have increased to the pro forma amounts shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Net loss As reported |
|
$ |
(657,730 |
) |
|
$ |
(344,011 |
) |
|
$ |
(2,855,759 |
) |
|
$ |
(1,119,976 |
) |
Deduct: Total
stock-based employee
compensation expense
determined under fair
value based method
for all awards |
|
|
(274,235 |
) |
|
|
(1,465,167 |
) |
|
|
(1,268,423 |
) |
|
|
(1,514,498 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss Pro forma |
|
$ |
(931,965 |
) |
|
$ |
(1,809,178 |
) |
|
$ |
(4,124,182 |
) |
|
$ |
(2,634,474 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share As reported: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.10 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share Pro forma: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.14 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.62 |
) |
|
$ |
(0.57 |
) |
On February 2, 2006, our Board of Directors approved a plan to accelerate, effective February 2,
2006, the vesting of out-of-the-money, unvested stock options previously granted to our employees,
officers and directors. An option was considered out-of-the-money if the stated exercise price
exceeded $2.85, the closing price of our common stock on February 2, 2006. Pursuant to this
action, options to purchase approximately 0.4 million shares of our common stock with a weighted
average exercise price of $4.49 per share became exercisable immediately.
The purpose of accelerating the vesting of these options was to minimize the amount of compensation
expense we must recognize upon adoption of SFAS No. 123(R). None of these options had intrinsic
value on February 2, 2006 under APB 25. The acceleration of the vesting of these options is
estimated to reduce our pre-tax stock option expense, calculated using the Black-Scholes option
valuation model, by approximately $1.4 million, in the aggregate, over the next three fiscal years,
upon adoption of SFAS No. 123R. We will include the charge attributed to the accelerated vesting
of the options in the pro forma disclosures to our consolidated financial statements and Form
10-KSB for the fiscal year ended March 31, 2006. We do not
expect the remaining options, except those with a cashless exercise
provision, to result in a significant charge to compensation expense
upon adoption of SFAS 123(R) under the modified prospective
application method. However, certain already-granted options, that
permit cashless exercise of the options, could result in significant
charge to compensation expense, as those options will need to be
marked to fair value at each reporting period until settlement. Also, additional options as
granted to attract or retain new employees could result in significant charge to compensation
expense.
10. 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, 2005 and 2004, 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. As of that date, 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.
Page 11
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, 2005 and
2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Gross service cost |
|
$ |
47,882 |
|
|
$ |
41,098 |
|
|
$ |
148,107 |
|
|
$ |
118,351 |
|
Interest cost |
|
|
22,755 |
|
|
|
22,817 |
|
|
|
73,565 |
|
|
|
65,860 |
|
Expected return on assets |
|
|
(12,710 |
) |
|
|
(14,335 |
) |
|
|
(42,025 |
) |
|
|
(41,442 |
) |
Amortization |
|
|
6,869 |
|
|
|
14,317 |
|
|
|
21,172 |
|
|
|
41,835 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic retirement cost |
|
$ |
64,796 |
|
|
$ |
63,897 |
|
|
$ |
200,819 |
|
|
$ |
184,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Major assumptions used in the above calculations include:
|
|
|
|
|
|
|
|
|
|
|
Three and Nine Months Ended |
|
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Discount rate |
|
|
4.50-5.25 |
% |
|
|
5.25-5.50 |
% |
Expected return on assets |
|
|
4.00-5.00 |
% |
|
|
4.50-5.00 |
% |
Expected rate of increase in future
compensation: |
|
|
|
|
|
|
|
|
General |
|
|
3 |
% |
|
|
3 |
% |
Individual |
|
|
0%-3 |
% |
|
|
0%-3 |
% |
11. 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 are not deemed to be long-term balances. For the three-months ended December 31, 2005
and 2004, we recognized foreign currency losses of $7,374 and $6,478, respectively. For the
nine-months ended December 31, 2005 and 2004, we recognized foreign currency losses of $15,779 and
$20,564, respectively.
12. Income Tax Expense
During the quarters ended December 31, 2005 and 2004, our Dutch subsidiaries recorded income tax
expense of $39,942 and $86,311, respectively. For the nine-months ended December 31, 2005 and 2004,
our Dutch subsidiaries recorded income tax expense of $42,648 and $138,540, respectively. We cannot
use our U.S. net operating loss carry forwards to offset taxable income in foreign jurisdictions.
Page 12
13. Business Segment and Geographic Information
We sell proprietary products for the treatment of voiding dysfunctions. Our primary product is
Macroplastique®, a soft tissue bulking material used for the treatment of urinary incontinence
and vesicoureteral reflux. In addition, we market our soft tissue bulking material for additional
indications, including the treatment of vocal cord rehabilitation, fecal incontinence and soft
tissue facial augmentation. At this time, all sales for the tissue bulking agent products are
outside the United States. Our Macroplastique product line accounted for 68% and 77% of total net
sales for the nine months ended December 31, 2005 and 2004, respectively.
In August 2005, we received U.S. Food and Drug Administration (FDA) 510(k) premarket clearance of
our I-Stop polypropylene, tension-free, mid-urethral sling for the treatment of female urinary
incontinence. We distribute this product in the United States and the United Kingdom. In October
2005, we received U.S. FDA 510(k) premarket clearance of our
Urgent® PC Neuromodulation System,
the only minimally invasive nerve stimulation device designed for office-based treatment of
overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency. We
started selling the Urgent PC device in November 2005 in the United States, and in December 2005 in
Europe and Canada. The Urgent PC is also indicated for the treatment of fecal incontinence outside
the United States. In addition, we sell specialized wound care products in The Netherlands and
United Kingdom as a distributor.
Based upon the above, we operate in only one reportable segment consisting of medical products
primarily for the urology market.
Information regarding operations in different geographies for the three and nine-months ended
December 31, 2005 and 2004 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments |
|
|
|
|
|
|
United |
|
|
The |
|
|
United |
|
|
and |
|
|
|
|
|
|
States |
|
|
Netherlands |
|
|
Kingdom |
|
|
Eliminations |
|
|
Consolidated |
|
Fiscal 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales to customers,
three-months ended
December 31, 2005 |
|
$ |
62,065 |
|
|
$ |
1,279,265 |
|
|
$ |
397,904 |
|
|
$ |
(146,708 |
) |
|
$ |
1,592,526 |
|
Sales to customers,
nine-months ended
December 31, 2005 |
|
|
63,415 |
|
|
|
3,855,471 |
|
|
|
1,316,432 |
|
|
|
(442,184 |
) |
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales to customers,
three-months ended
December 31, 2004 |
|
$ |
|
|
|
$ |
1,394,658 |
|
|
$ |
391,419 |
|
|
$ |
(176,385 |
) |
|
$ |
1,609,692 |
|
Sales to customers,
nine-months ended
December 31, 2004 |
|
|
|
|
|
|
4,255,905 |
|
|
|
1,264,274 |
|
|
|
(507,267 |
) |
|
|
5,012,912 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense,
three-months ended
December 31, 2004 |
|
|
|
|
|
|
86,311 |
|
|
|
|
|
|
|
|
|
|
|
86,311 |
|
Income tax expense,
nine-months ended
December 31, 2004 |
|
|
|
|
|
|
138,540 |
|
|
|
|
|
|
|
|
|
|
|
138,540 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss),
three-months ended
December 31, 2004 |
|
|
(520,693 |
) |
|
|
165,788 |
|
|
|
14,178 |
|
|
|
(3,284 |
) |
|
|
(344,011 |
) |
Net income (loss),
nine-months ended
December 31, 2004 |
|
|
(1,495,654 |
) |
|
|
271,347 |
|
|
|
8,773 |
|
|
|
95,558 |
|
|
|
(1,119,976 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets
At December 31,
2004 |
|
|
294,293 |
|
|
|
832,063 |
|
|
|
14,961 |
|
|
|
|
|
|
|
1,141,317 |
|
14. Subsequent Event
On January 20, 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 is May 1, 2006, has a term of 96 months, requires
average annual minimum rent payments of $140,358 and requires payments for operating expenses
estimated to be $81,978 in the first 12 months.
Page 13
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, 2005.
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. We have developed, and are developing,
minimally invasive products primarily for the treatment of urinary and fecal incontinence and
overactive bladder symptoms.
Our primary product is Macroplastique, a soft tissue bulking material, used for the treatment of
urinary incontinence and vesicoureteral reflux. In addition, we market our soft tissue bulking
material for additional indications, including for the treatment of vocal cord rehabilitation,
fecal incontinence and soft tissue facial augmentation. We have received CE marking for European
market clearance on all tissue bulking products we currently sell. At this time, all sales for the
tissue bulking agent products are outside the United States in approximately 40 countries,
including Europe, Canada, Australia and Latin America.
In August 2005, we received U.S. Food and Drug Administration 510(k) premarket clearance of our
I-STOP polypropylene, tension-free, mid-urethral sling for the treatment of female urinary
incontinence. We distribute this product in the United States and the United Kingdom. In October
2005, we received U.S. FDA 510(k) premarket clearance of our
Urgent® PC Neuromodulation System,
the only minimally invasive nerve stimulation device designed for office-based treatment of
overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency. We
started selling the Urgent PC device in November 2005 in the United States, and in December 2005 in
Europe and Canada. The Urgent PC is also indicated for the treatment of fecal incontinence outside
the United States. In addition, we sell specialized wound care products in The Netherlands and
United Kingdom as a distributor.
Our goal is to develop and commercialize a portfolio of minimally invasive products for the
treatment of voiding dysfunctions. We believe that, with a suite of innovative products, we can
increasingly garner the attention of key physicians and distributors and enhance market acceptance
of our products. The key elements of our strategy are to:
|
|
|
Pursue regulatory approval in the U.S. for our Macroplastique product line. |
Page 14
|
|
|
Successfully market and sell Urgent PC and I-Stop products by building our own U.S.
marketing and sales organization, using a combination of direct and independent sales
representatives; |
|
|
|
|
Expand distribution of our products outside of the U.S.; and |
|
|
|
|
Acquire or license complimentary products if appropriate opportunities arise. |
In furtherance of our first key strategy above, we are concluding a multi-center human clinical
trial using Macroplastique in a minimally invasive, office-based procedure for treating adult
female stress urinary incontinence resulting from intrinsic sphincter deficiency. This is the
weakening of the muscles that control the flow of urine from the bladder. We filed a pre-market
approval (PMA) submission with the FDA describing Macroplastique use for this indication. In July
2005, the FDA recommended we conduct further testing, which we expect will delay possible approval
of Macroplastique until late 2007. We will incur substantial expense in connection with these
regulatory activities. For the I-Stop tape, we have an exclusive distribution agreement with the
product manufacturer, CL Medical. We are also responsible for obtaining and/or maintaining FDA and
foreign regulatory approvals for the Urgent PC system.
In the United States,
we have incurred significant expenses during fiscal 2006 to build our direct
sales and marketing organizations to market our products and support our distributor organizations.
We will incur significant additional expenses and will need to raise
additional debt or equity financing as we further expand our sales and marketing
organizations.
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. We market and distribute our products through a network of distributors and
through direct sales to end-users in the United Kingdom, The Netherlands and the United States. 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. Our respective distribution agreements govern sales terms and
pricing to our distributors. 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. However, during each of the last two years, we believe these two
sales measures were not substantially different. 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 financial 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. We translate the financial
statements of our foreign subsidiaries in accordance with the provisions of FASB Statement 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,
Page 15
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, 2005 consist of property, plant
and equipment and intangible assets. We review our long-lived assets for impairment whenever events
or business circumstances indicate that we may not recover the carrying amount of an asset. 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 recognize as impairment 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.
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, 2005 and 2004.
Results of Operations
Three-month period ended December 31, 2005 compared to three-month period ended December 31, 2004
Net Sales: In the third quarter ended December 31, 2005, net sales of all products were $1.6
million, representing a $17,000 or 1% decrease when compared to net sales of $1.6 million for the
quarter ended December 31, 2004. Excluding fluctuations in foreign currency exchange rates, we had
a sales increase of approximately 7%. The Macroplastique product line accounted for 64% and 76% of
total net sales, respectively, for the quarters presented. Two of our former top six distributor
markets generated minimal sales in the quarter ended December 31, 2005, due in part to changes in
reimbursement policies of the insurers. We expect these reimbursement changes
and increase in pricing competition in our other markets
to adversely impact
our future sales in those markets. In such markets we have launched a strategy to increase sales of
our existing products, and to expand our platform of products for the treatment of voiding
dysfunctions. We are conducting training workshops targeted to our sales personnel, distributors
and key incontinence surgeons, and we are sponsoring scientific podium presentations and seminars
at key international incontinence congresses. We are also seeking to broaden our patient base to
include Urgent PC treatment for symptoms of overactive bladder (OAB), the I-STOP sling procedure
for treatment of female stress urinary incontinence (SUI) and hypermobility and PTQ Implants and
Urgent PC treatments for fecal incontinence. We cannot assure that these initiatives will increase
sales.
Gross Profit: Gross profit was $1.2 million for both quarters ended December 31, 2005 and 2004,
respectively, or 75% and 76% of net sales in the periods presented. Gross profit as a percentage of
net sales between periods fluctuates based on the following factors: our unit sales, our
utilization of manufacturing capacity, the mix of products sold with different gross margins, the
mix of customers (and different discounts to them), the mix of direct sales versus sales through
distributors (with higher margins on direct sales), and currency fluctuations. Historically, our
gross margin has ranged from approximately 70-80% of net sales.
General and Administrative Expenses: General and administrative expenses increased from $504,000
during the third quarter of fiscal 2005 to $859,000 during the third quarter of fiscal 2006. The
increase in expenses is attributed to $190,000 of increase in salary costs, including $100,000 for
severance pay to a former executive, $62,000 of increase in information (IT) consulting expense,
and general price increases and fluctuations in foreign currency exchange rates. The IT consulting
expense relates to the implementation of a new computer software system, including for training and
post-implementation support.
Research and Development Expenses: Research and development expenses increased from $559,000
during the third quarter of fiscal 2005 to $700,000 during the third quarter of fiscal 2006. The
increase in expenses is attributed to $360,000 of consulting expenses for product development and
regulatory approvals, offset by a reduction in costs for clinical trials and testing.
Selling and Marketing Expenses: Selling and marketing expenses increased from $417,000 during the
third quarter of fiscal 2005 to $852,000 during the third quarter of fiscal 2006. The increase in
expenses is attributed to $288,000 for expansion of our direct sales force and marketing
organizations in the U.S., $60,000 for increase in costs for travel, trade-shows and conventions,
and general price increases and fluctuations in foreign currency exchange rates.
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
Page 16
material fluctuations based on changes in currency
exchange rates. Other income (expense) was $593,000 and $(3,824) for the third quarter ended
December 31, 2005 and 2004, respectively.
In July 2002, we conducted a rights offering pursuant to which our stockholders purchased certain
units consisting of shares of our common stock and common stock purchase warrants exercisable for
two years at $2.00 per share. However, we suspended the exercise of the warrants when we delayed
the filing of our annual report on Form 10-KSB for the fiscal year ended March 31, 2004. As a
result, 706,218 of the warrants lapsed unexercised at July 31, 2004. In April 2005, we granted a
like number of new common stock purchase warrants to the holders of the expired warrants. The new
warrants will be exercisable at $2.00 per share for 90 days after the effective date of a new
registration statement covering the resale of the shares underlying these warrants. We have filed
a registration statement on Form SB-2 with the Securities and Exchange Commission (SEC), expect to
file an amendment to the registration statement in February 2006 covering the warrant shares, and
anticipate the effectiveness of the registration statement to be in March 2006, subject entirely to
the action taken by the SEC on our registration statement. In April 2005, we recognized a
liability of $1.4 million associated with the grant of these warrants. We reported a benefit of
$560,000 in the third quarter, a benefit of $701,000 in the second quarter and an expense of
$686,000 in the first quarter due to the changes in the fair value of the common stock which may be
acquired by exercise of these warrants at December 31, 2005, September 30, 2005 and June 30, 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
losses of $7,374 and $6,478 for the third quarter ended December 31, 2005 and 2004, respectively.
Income Tax Expense: Our Dutch subsidiaries recorded income tax expense of $39,942 and $86,311 for
the quarters ended December 31, 2005 and 2004, respectively. For fiscal 2006, the Dutch income tax
rate is 27% for 22,689 (approximately $27,000) of profit and
31.5% for amounts above 22,689
compared to 29% and 34.5% in fiscal 2005, respectively.
Nine-month period ended December 31, 2005 compared to nine-month period ended December 31, 2004
Net Sales: During the nine months ended December 31, 2005, net sales of all products were $4.8
million, representing a $220,000 or 4% decrease when compared to net sales of $5.0 million for the
nine months ended December 31, 2004. Excluding fluctuations in foreign currency exchange rates, we
had a sales decrease of approximately 3%. The Macroplastique product line accounted for 68% and 77%
of total net sales, respectively, for the periods presented. In the United Kingdom, we did not
achieve our forecasted rate for converting physician use of competitive sling devices to our I-Stop
product. In addition, two of our former top six distributor markets generated minimal sales in the
nine months ended December 31, 2005, due in part to changes in reimbursement policies of the
insurers. We expect these reimbursement changes to adversely impact our future sales in those
markets. In such markets we have launched a strategy to increase sales of our existing products,
and to expand our platform of products for the treatment of voiding dysfunctions. We are
conducting training workshops targeted to our sales personnel, distributors and key incontinence
surgeons, and we are sponsoring scientific podium presentations and seminars at key international
incontinence congresses. We are also seeking to broaden our patient base to include Urgent PC
treatment for symptoms of overactive bladder (OAB), the I-STOP sling procedure for treatment of
female stress urinary incontinence (SUI) and hypermobility and PTQ Implants and Urgent PC
treatments for fecal incontinence. We can not assure that these initiatives will increase sales.
Gross Profit: Gross profit was $3.5 million and $3.7 million for the nine months ended December
31, 2005 and 2004, respectively, or 73% and 74% of net sales in the periods presented. Gross profit
as a percentage of net sales between periods fluctuates based on the following factors: our unit
sales, our utilization of manufacturing capacity, the mix of products sold with different gross
margins, the mix of customers (and different discounts to them), the mix of direct sales versus
sales through distributors (with higher margins on direct sales), and currency fluctuations.
Historically, the gross margin has ranged from approximately 70-80% of net sales.
General and Administrative Expenses: General and administrative expenses increased from $1.4
million during the nine months ended December 31, 2004 to $2.3 million during the same period of
fiscal 2006. The increase in expense is attributed to $340,000 of increase in salary costs,
including $100,000 for severance pay for a former executive, $166,000 increase in information
(IT) consulting expense, $110,000 increase in legal and accounting fees, $60,000 increase in
recruiting costs, and general price increases and fluctuations in foreign currency exchange rates.
The IT consulting expense relates to the implementation of a new computer software system,
including for training and post-implementation support.
Research and Development Expenses: Research and development expenses increased from $1.7 million
during the nine-months ended December 31, 2004 to $2.4 million during the nine months ended
December 31, 2005. The increase in expense
Page 17
is attributed $499,000 for consulting expense for
product development and regulatory approvals and $219,000 for severance pay for a former executive,
offset by a reduction in costs for clinical trials and testing.
Selling and Marketing Expenses: Selling and marketing expenses increased from $1.5 million during
the nine months ended December 31, 2004 to $2.3 million during the nine months ended December 31,
2005. The increase in expenses is attributed to $380,000 for expansion of our direct sales force
and marketing organizations in the U.S., $120,000 for increase in costs for travel, trade-shows and
conventions, and general price increases and fluctuations in foreign currency exchange rates.
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 (expense) was $645,546 and $13,153 for the nine months ended December
31, 2005 and 2004, respectively.
In July 2002, we conducted a rights offering pursuant to which our stockholders purchased certain
units consisting of shares of our common stock and common stock purchase warrants exercisable for
two years at $2.00 per share. However, we suspended the exercise of the warrants when we delayed
the filing of our annual report on Form 10-KSB for the fiscal year ended March 31, 2004. As a
result, 706,218 of the warrants lapsed unexercised at July 31, 2004. In April 2005, we granted a
like number of new common stock purchase warrants to the holders of the expired warrants. The new
warrants will be exercisable at $2.00 per share for 90 days after the effective date of a new
registration statement covering the resale of the shares underlying these warrants. We have filed
a registration statement on Form SB-2 with the Securities and Exchange Commission (SEC), expect to
file an amendment to the registration in February 2006 covering the warrant shares and anticipate
the effectiveness of the registration statement to be in March 2006, subject entirely to the action
taken by SEC on our registration statement. In April 2005, we recognized a liability of $1.4
million associated with the grant of these warrants. We reported a net warrant benefit of $575,000
for the first nine months of fiscal 2006, representing the change in the fair value of the common
stock which may be acquired by the exercise of these warrants since issuance.
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
losses of $15,779 and $20,564 for the nine-months ended December 31, 2005 and 2004, respectively.
Income Tax Expense: Our Dutch subsidiaries recorded income tax expense of $42,648 and $138,540 for
the nine-months ended December 31, 2005 and 2004, respectively. We cannot use the U.S. net
operating loss carry forwards to offset taxable income in foreign jurisdictions. In fiscal 2006,
the Dutch income tax rate is 27% for 22,689 (approximately $27,000) of profit and 31.5% for
amounts above 22,689 compared to 29% and 34.5% in fiscal 2005, respectively.
Liquidity and Capital Resources
Cash Flows. As of December 31, 2005, our cash and cash equivalent balances totaled $4.1 million.
At December 31, 2005, we had working capital of approximately $4.2 million. During the nine months
ended of fiscal 2006, we used $3.4 million of cash in operating
activities, compared to $1.0 million
of cash used in the same period of fiscal 2005. The usage of cash over the nine months was
primarily attributable to the net loss incurred of $2.9 million. Inventory increased by $350,000,
due to production planning requirements, manufacturing lead times and additional products being
added. Accounts receivable, other current assets, accounts payable and accrued expenses fluctuated
due to the timing of payments and fluctuations in foreign currency exchange rates.
Fluctuations in foreign currency exchange
rates, weak economic conditions in foreign markets
where we sell and distribute our products, changes in regulatory
environment and changes in third-party reimbursement policies could materially affect our financial condition and
results of operations. The effects of these conditions could include reduced unit sales and
reduced sales in dollars when converted from foreign currency amounts and material gains and losses
on transactions denominated in foreign currencies. Furthermore, because our U.S. operations are
funded by sales denominated in foreign currency, strengthening of the U.S. dollar against the euro
and/or the British pound could have an adverse effect on our cash flow and results of operations.
Sources of Liquidity. In March 2005, we entered into a business loan agreement with Venture Bank,
pursuant to which we may borrow up to $500,000 on a revolving basis. All amounts which the bank
advances to us are due in March 2006, unless the bank renews the agreement. Amounts advanced to us
accrue interest at a variable rate of 1% in excess of the published prime rate in the Wall Street
Journal, with a minimum rate of 6% per annum. We are obligated to pay interest monthly on the
Page 18
outstanding principal balance. Advances under this agreement are secured by substantially all our
assets. At December 31, 2005 we had no outstanding balance under the agreement.
In April 2005, we conducted a private placement of common stock 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 common stock, for an aggregate purchase price of approximately $7.5 million. The stock
sale proceeds are offset by costs of approximately $856,000, resulting in net proceeds of
approximately $6.7 million. The warrants are exercisable for five years at an exercise price of
$4.75 per share.
In connection with our April 2005 private placement, we agreed to file a registration statement
with the SEC covering the resale of the shares (including those underlying the warrants) that we
sold. We also agreed that, for each month after May 21, 2005, that we failed to file this
registration statement, and for each month after July 20, 2005 that the SEC did not declare it
effective, we would pay liquidated damages at a rate of 1% of the aggregate investment. We filed
the registration statement on July 20, 2005 and the SEC declared it effective on July 29, 2005.
Accordingly, we owe approximately $173,000 of liquidated damages and interest to the investors,
which will continue to accrue interest at 10% per annum until paid. We have offered these investors
our common stock in lieu of cash, but we cannot assure that all or any of the investors will accept
our offer. We recorded a liability in our financial statements beginning in the first quarter of
fiscal 2006 related to these liquidated damages.
Commitments and Contingencies. We believe that our current resources, funds generated from sale of
our products and remaining proceeds from the private
placement completed earlier this year will be adequate to meet our cash flow needs, including
regulatory activities associated with existing products, through the
next twelve months. Ultimately, we will
need to raise additional debt or equity financing, achieve
profitability and generate positive cash flows from operations to fund our operations and
grow our business beyond the next twelve months.
We expect to continue to incur significant costs for regulatory activities associated with
obtaining regulatory approval in the United States for Macroplastique. For the remainder of fiscal
2006 and in fiscal 2007, we expect to incur significant Research and Development expenses,
including those we expect to incur in connection with the regulatory approval activities for
Macroplastique. We also expect that during fiscal 2006, we will continue to incur significant
expenses as we expand our selling and marketing organization in the U.S. to market our products.
In addition, we expect general and administrative expenses in fiscal 2007 to increase as we
complete installation of our new accounting software and increasingly prepare to implement the
provisions of Section 404 of the Sarbanes-Oxley Act of 2002.
In April 2005, we entered into an exclusive manufacturing and distribution agreement with
CystoMedix for the Urgent PC product. We paid CystoMedix an initial payment of $225,000, which we
capitalized as licensed technology and are amortizing over the term of the agreement. We are paying
an additional $250,000 in 12 monthly installments of $20,833. We will also pay CystoMedix a 7%
royalty on product sales. However, the 7% royalty is first offset against the monthly royalty
installments.
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 between January 2006 and 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 are obligated to pay royalties of 5% of net sales of Macroplastique products in the U.S. with a
minimum of $50,000 per year. The duration of this royalty agreement is through 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 16 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
Page 19
based on continued service and future salary
increases. This defined benefit plan is closed for new employees effective 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.
We have two exclusive distribution agreements with CL Medical allowing us to market and sell the
I-Stop urethral sling: a five-year agreement for United States distribution and a one-year
agreement for the United Kingdom distribution. We also have specified minimum purchase
requirements in the United States of $320,000 of units in the first year, increasing to
approximately $1.9 million of units over a five-year period, for a total commitment of $4.7 million
over the five-year period, subject to periodic adjustment based on the value of the euro.
On January 20, 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 is May 1, 2006, has a term of 96 months, requires
average annual minimum rent payments of $140,358 and requires payments for operating expenses
estimated to be $81,978 in the first 12 months.
Repayments of our contractual
obligations as of December 31, 2005, consisting of royalties, notes payable, and operating
leases including the January 20, 2006 lease noted above, are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by
Period |
|
|
|
|
|
|
|
Remainder |
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
|
|
|
|
|
of Fiscal |
|
|
2007 to |
|
|
2009 to |
|
|
2011 and |
|
|
|
Total |
|
|
2006 |
|
|
2009 |
|
|
2011 |
|
|
thereafter |
|
Minimum royalty payments |
|
$ |
394,333 |
|
|
$ |
76,000 |
|
|
$ |
178,833 |
|
|
$ |
108,000 |
|
|
$ |
31,500 |
|
Minimum purchase agreement |
|
|
4,658,024 |
|
|
|
98,040 |
|
|
|
1,093,328 |
|
|
|
2,826,656 |
|
|
|
640,000 |
|
Notes payable |
|
|
431,386 |
|
|
|
10,180 |
|
|
|
81,442 |
|
|
|
71,530 |
|
|
|
268,234 |
|
Operating lease commitments |
|
|
1,234,180 |
|
|
|
75,708 |
|
|
|
472,806 |
|
|
|
308,118 |
|
|
|
377,548 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
6,717,923 |
|
|
$ |
259,928 |
|
|
$ |
1,826,409 |
|
|
$ |
3,314,304 |
|
|
|
1,317,282 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITEM 3. CONTROLS AND PROCEDURES.
Disclosure Controls and 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 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 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 quarter ended December 31, 2005, 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 20
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, 2005.
ITEM 1. LEGAL PROCEEDINGS
On July 15, 2005, our former Vice President of Research and Development and Managing Partner of our
United Kingdom subsidiary filed a petition in Dutch court. The petition requested the Dutch court
to terminate his employment agreement with us and made a claim for severance compensation as well
as other damages. In August 2005, the Dutch court granted a total award to the former employee
of approximately $219,000, which we accrued in the second quarter consolidated financial statements
and paid in the third quarter.
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 21
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.
|
|
|
|
|
|
|
UROPLASTY, INC. |
|
|
|
|
|
|
|
Date: February 14, 2006 |
|
by: /s/ SAM B. HUMPHRIES |
|
|
|
|
|
|
|
|
|
|
|
Sam B. Humphries |
|
|
|
|
President and Chief Executive Officer |
|
|
|
|
|
|
|
|
|
Date: February 14, 2006 |
|
by: /s/ MAHEDI A. JIWANI |
|
|
|
|
|
|
|
|
|
|
|
Mahedi A. Jiwani |
|
|
|
|
Chief Financial Officer |
|
|
Page 22
Exhibit 31.1
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Sam B. Humphries, certify that:
1. I have reviewed this report on Form 10-QSB for the quarterly period ended December 31, 2005 of
Uroplasty, Inc. (the Registrant);
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 Registrant as of, and for, the periods presented in this report;
4. The Registrants 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)) for
the Registrant 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 Registrant, 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 Registrants 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 Registrants internal control over financial
reporting that occurred during the Registrants most recent fiscal quarter that has materially
affected, or is reasonably likely to materially affect, the Registrants internal control over
financial reporting; and
5. The Registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the Registrants auditors and the audit
committee of the Registrants board of directors (or persons performing the equivalent function):
(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 Registrants
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 Registrants internal control over financial reporting.
|
|
|
|
|
Date: February 14, 2006
|
|
|
|
|
|
|
By
|
|
/s/ SAM B. HUMPHRIES |
|
|
|
|
|
|
|
|
|
Sam B. Humphries, President and Chief Executive Officer |
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, 2005 of
Uroplasty, Inc. (the Registrant);
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 Registrant as of, and for, the periods presented in this report;
4. The Registrants 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)) for
the Registrant 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 Registrant, 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 Registrants 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 Registrants internal control over financial
reporting that occurred during the Registrants most recent fiscal quarter that has materially
affected, or is reasonably likely to materially affect, the Registrants internal control over
financial reporting; and
5. The Registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the Registrants auditors and the audit
committee of the Registrants board of directors (or persons performing the equivalent function):
(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 Registrants
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 Registrants internal control over financial reporting.
|
|
|
|
|
Date: February 14, 2006
|
|
|
|
|
|
|
By
|
|
/s/ MAHEDI A. JIWANI |
|
|
|
|
|
|
|
|
|
Mahedi A. Jiwani, Chief Financial Officer |
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, 2005 as filed with the Securities and Exchange Commission on
the date hereof (the Report), I, Sam B. Humphries, 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/ SAM B. HUMPHRIES
Sam B. Humphries
Chief Executive Officer
Dated: February 14, 2006
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, 2005 as filed with the Securities and Exchange Commission on
the date hereof (the Report), I, Daniel G. Holman, 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 14, 2005