e10qsb
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, 2007
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.) |
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
large accelerated filer, an accelerated filer, or a non-accelerated filer. See definitions
of accelerated filer and large accelerated filer in Rule 12b-2 of the
Exchange Act.
|
|
|
|
|
Large Accelerated Filer o |
|
Accelerated Filer o |
|
Non-accelerated Filer þ |
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 31, 2008 was 14,916,540.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
|
|
|
|
|
(unaudited) |
|
|
March 31, 2007 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
7,858,814 |
|
|
$ |
3,763,702 |
|
Short-term investments |
|
|
2,448,447 |
|
|
|
3,000,000 |
|
Accounts receivable, net |
|
|
1,837,827 |
|
|
|
1,240,141 |
|
Income tax receivable |
|
|
|
|
|
|
113,304 |
|
Inventories |
|
|
832,771 |
|
|
|
823,601 |
|
Other |
|
|
207,364 |
|
|
|
272,035 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
13,185,223 |
|
|
|
9,212,783 |
|
|
|
|
|
|
|
|
|
|
Property, plant, and equipment, net |
|
|
1,553,000 |
|
|
|
1,431,749 |
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
4,426,101 |
|
|
|
308,093 |
|
|
|
|
|
|
|
|
|
|
Deferred tax assets |
|
|
96,399 |
|
|
|
93,819 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
19,260,723 |
|
|
$ |
11,046,444 |
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 2
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
|
March 31, 2007 |
|
|
|
(unaudited) |
|
|
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Current maturities long-term debt |
|
$ |
82,744 |
|
|
$ |
78,431 |
|
Deferred rent current |
|
|
35,000 |
|
|
|
35,000 |
|
Accounts payable |
|
|
653,982 |
|
|
|
544,507 |
|
Accrued liabilities |
|
|
1,705,592 |
|
|
|
1,347,670 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,477,318 |
|
|
|
2,005,608 |
|
|
|
|
|
|
|
|
|
|
Long-term debt less current maturities |
|
|
405,761 |
|
|
|
427,382 |
|
Deferred rent less current portion |
|
|
189,329 |
|
|
|
214,381 |
|
Accrued pension liability |
|
|
346,838 |
|
|
|
596,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
3,419,246 |
|
|
|
3,243,397 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Common stock $.01 par value; 40,000,000
shares authorized, 14,916,540 and
11,614,330 shares issued and
outstanding at December 31 and
March 31, 2007, respectively |
|
|
149,165 |
|
|
|
116,143 |
|
Additional paid-in capital |
|
|
34,863,978 |
|
|
|
23,996,818 |
|
Accumulated deficit |
|
|
(19,136,685 |
) |
|
|
(16,010,990 |
) |
Accumulated other comprehensive loss |
|
|
(34,981 |
) |
|
|
(298,924 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
15,841,477 |
|
|
|
7,803,047 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
19,260,723 |
|
|
$ |
11,046,444 |
|
|
|
|
|
|
|
|
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, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net sales |
|
$ |
3,729,314 |
|
|
$ |
2,158,273 |
|
|
$ |
9,717,531 |
|
|
$ |
5,683,253 |
|
Cost of goods sold |
|
|
789,955 |
|
|
|
752,181 |
|
|
|
2,053,208 |
|
|
|
1,760,553 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
2,939,359 |
|
|
|
1,406,092 |
|
|
|
7,664,323 |
|
|
|
3,922,700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
799,193 |
|
|
|
707,288 |
|
|
|
2,755,000 |
|
|
|
2,365,574 |
|
Research and development |
|
|
460,374 |
|
|
|
424,987 |
|
|
|
1,393,496 |
|
|
|
1,758,350 |
|
Selling and marketing |
|
|
2,399,227 |
|
|
|
1,301,575 |
|
|
|
6,006,598 |
|
|
|
3,837,858 |
|
Amortization of intangibles |
|
|
209,862 |
|
|
|
25,210 |
|
|
|
632,865 |
|
|
|
78,323 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,868,656 |
|
|
|
2,459,060 |
|
|
|
10,787,959 |
|
|
|
8,040,105 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(929,297 |
) |
|
|
(1,052,968 |
) |
|
|
(3,123,636 |
) |
|
|
(4,117,405 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
74,928 |
|
|
|
15,776 |
|
|
|
216,550 |
|
|
|
53,592 |
|
Interest expense |
|
|
(6,497 |
) |
|
|
(8,671 |
) |
|
|
(27,141 |
) |
|
|
(25,136 |
) |
Warrant benefit |
|
|
|
|
|
|
522,995 |
|
|
|
|
|
|
|
150,315 |
|
Foreign currency exchange gain (loss) |
|
|
(37,632 |
) |
|
|
4,413 |
|
|
|
(53,538 |
) |
|
|
34,376 |
|
Other, net |
|
|
2,134 |
|
|
|
|
|
|
|
4,014 |
|
|
|
3,585 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32,933 |
|
|
|
534,513 |
|
|
|
139,885 |
|
|
|
216,732 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(896,364 |
) |
|
|
(518,455 |
) |
|
|
(2,983,751 |
) |
|
|
(3,900,673 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
4,004 |
|
|
|
44,802 |
|
|
|
141,944 |
|
|
|
62,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(900,368 |
) |
|
$ |
(563,257 |
) |
|
$ |
(3,125,695 |
) |
|
$ |
(3,963,386 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share |
|
$ |
(0.06 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.51 |
) |
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
14,119,583 |
|
|
|
8,555,586 |
|
|
|
13,482,928 |
|
|
|
7,766,463 |
|
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, 2007
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Shareholders |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Loss |
|
|
Equity |
|
Balance (deficit)
at March 31, 2007 |
|
|
11,614,330 |
|
|
$ |
116,143 |
|
|
$ |
23,996,818 |
|
|
$ |
(16,010,990 |
) |
|
$ |
(298,924 |
) |
|
$ |
7,803,047 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common
stock in connection
with the purchase
of intellectual
property |
|
|
1,417,144 |
|
|
|
14,171 |
|
|
|
4,644,690 |
|
|
|
|
|
|
|
|
|
|
|
4,658,861 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from
secondary offering,
net of issuance
costs of $526,465 |
|
|
1,466,400 |
|
|
|
14,664 |
|
|
|
4,591,271 |
|
|
|
|
|
|
|
|
|
|
|
4,605.935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Registration costs
private placement |
|
|
|
|
|
|
|
|
|
|
(17,000 |
) |
|
|
|
|
|
|
|
|
|
|
(17,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from
exercise of
warrants |
|
|
50,000 |
|
|
|
500 |
|
|
|
149,500 |
|
|
|
|
|
|
|
|
|
|
|
150,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from
exercise of stock
options |
|
|
368,666 |
|
|
|
3,687 |
|
|
|
631,611 |
|
|
|
|
|
|
|
|
|
|
|
635,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
consulting and
compensation
expense |
|
|
|
|
|
|
|
|
|
|
867,088 |
|
|
|
|
|
|
|
|
|
|
|
867,088 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,125,695 |
) |
|
|
263,943 |
|
|
|
(2,861,752 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance(deficit) at
December 31, 2007 |
|
|
14,916,540 |
|
|
$ |
149,165 |
|
|
$ |
34,863,978 |
|
|
$ |
(19,136,685 |
) |
|
$ |
(34,981 |
) |
|
$ |
15,841,477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 2007 and 2006
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,125,695 |
) |
|
$ |
(3,963,386 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
796,748 |
|
|
|
223,048 |
|
Gain on disposal of equipment |
|
|
(2,769 |
) |
|
|
(3,576 |
) |
Warrant benefit |
|
|
|
|
|
|
(150,315 |
) |
Stock-based consulting expense |
|
|
37,942 |
|
|
|
48,043 |
|
Stock-based compensation expense |
|
|
829,146 |
|
|
|
587,904 |
|
Deferred income taxes |
|
|
7,113 |
|
|
|
(64,694 |
) |
Deferred rent |
|
|
(26,250 |
) |
|
|
(23,333 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(534,542 |
) |
|
|
(365,812 |
) |
Inventories |
|
|
64,390 |
|
|
|
(149,247 |
) |
Other current assets and income tax receivable |
|
|
191,921 |
|
|
|
288,974 |
|
Accounts payable |
|
|
94,198 |
|
|
|
91,619 |
|
Accrued liabilities and income tax payable |
|
|
312,158 |
|
|
|
(24,069 |
) |
Accrued pension liability, net |
|
|
(247,388 |
) |
|
|
214,909 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(1,603,028 |
) |
|
|
(3,289,935 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Proceeds from sale of short-term investments |
|
|
4,200,000 |
|
|
|
1,137,647 |
|
Purchase of short-term investments |
|
|
(3,648,447 |
) |
|
|
|
|
Purchases of property, plant and equipment |
|
|
(210,875 |
) |
|
|
(150,578 |
) |
Proceeds from sale of equipment |
|
|
4,811 |
|
|
|
4,294 |
|
Payments for intangible assets |
|
|
(92,013 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
253,476 |
|
|
|
991,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from financing obligations |
|
|
178,374 |
|
|
|
210,999 |
|
Repayment of debt obligations |
|
|
(239,872 |
) |
|
|
(158,820 |
) |
Net proceeds from issuance of common stock, warrants and option exercise |
|
|
5,374,233 |
|
|
|
6,393,795 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
5,312,735 |
|
|
|
6,445,974 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
131,929 |
|
|
|
3,663 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
4,095,112 |
|
|
|
4,151,065 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
3,763,702 |
|
|
|
1,563,433 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
7,858,814 |
|
|
$ |
5,714,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
25,204 |
|
|
$ |
22,011 |
|
Cash paid during the period for income taxes |
|
|
87,900 |
|
|
|
93,935 |
|
Supplemental disclosure of non-cash financing and investing activities: |
|
|
|
|
|
|
|
|
Employee retirement savings plan contribution issued in common shares |
|
|
|
|
|
|
44,385 |
|
Property, plant and equipment additions funded by lessor allowance and
classified as deferred rent |
|
|
|
|
|
|
280,000 |
|
Purchase of intellectual property funded by issuance of stock |
|
|
4,658,861 |
|
|
|
|
|
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, 2007.
The condensed consolidated financial statements presented herein as of December 31, 2007 and for
the three- and nine-month periods ended December 31, 2007 and 2006 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, defined benefit pension plans and income
taxes, each of which is described in our Annual Report on Form 10-KSB for the year ended March 31,
2007. 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, 2007, and we have made
no changes to these policies during fiscal 2008.
2. Nature of Business, Sales of Common Stock and Corporate Liquidity
Overview
We are a medical device company that develops, manufactures and markets innovative proprietary
products for the treatment of voiding dysfunctions. Our primary focus is the commercialization of
our Urgent® PC system, which we believe is the only FDA-approved non-surgical
neurostimulation therapy for the treatment of overactive bladder symptoms (OAB). We also offer
Macroplastique® Implants, a bulking agent for the treatment of urinary incontinence. We
believe that physicians prefer our products because they offer an effective therapy for the
patient, can be administered in office-based settings and, with reimbursement in place, provide the
physicians a new profitable recurring revenue stream. We believe that patients prefer our products
because they are non-surgical treatment alternatives that do not have the side effects associated
with pharmaceutical treatment options.
Strategy
Our goal is to become the leading provider of non-surgical neurostimulation solutions for patients
who suffer from OAB symptoms. We also plan to market other innovative products to physicians
focused on office-based procedures for the treatment of urinary incontinence. We believe that,
with our Urgent PC and Macroplastique products, we will increasingly garner the attention of key
physicians, independent sales representatives and distributors to grow revenue. The key elements
of our strategy are to:
|
|
|
educate physicians about the benefits of our Urgent PC neurostimulation system; |
|
|
|
|
build patient awareness of office-based solutions; |
|
|
|
|
focus on office-based solutions for physicians; |
|
|
|
|
increase market coverage in the United States and internationally; and |
|
|
|
|
develop, license or acquire new products. |
Page 7
Our Products
The Urgent PC neurostimulation system is a minimally invasive device designed for office-based
treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary
frequency. The treatment can be administered by qualified office-based staff under the supervision
of a physician. The system uses percutaneous tibial nerve stimulation to deliver an electrical
pulse that travels to the sacral nerve plexus, a control center for bladder function. We have
received regulatory approvals for sale of the Urgent PC system in the United States, Canada and
Europe. We launched sales of our second generation Urgent PC system in late 2006.
Macroplastique is a minimally invasive, implantable soft tissue bulking product 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 the use of Macroplastique to treat female stress
incontinence. We began marketing this product in the United States in early 2007.
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 have expanded our sales organization, consisting of direct
field sales and independent sales representatives, marketing organization and reimbursement
department to market our products directly to our customers. By expanding our United Sates
presence, we intend to develop long-standing relationships with leading physicians treating
overactive bladder symptoms and incontinence.
Sales of Common Stock and Corporate Liquidity
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.
We believe we have sufficient liquidity to meet our needs over the next twelve months. However, we
may need to raise additional financing to support our operations and planned growth activities in
the future as we have yet to achieve profitability and generate positive cash flows. To achieve
profitability, we must generate substantially more revenue than we have this year or in prior
years. Our ability to achieve significant revenue growth will depend, in large part, on our
ability to achieve widespread market acceptance for our products and successfully expand our
business in the U.S., which we cannot guarantee will happen. There can be no guarantee that we
will be successful at raising additional equity or debt financing, as we currently have no
committed sources.
In November 2007, we conducted a follow-on public offering in which we sold 1,466,400 shares of our
common stock at a price per share of $3.50, for an aggregate purchase price of approximately $5.1
million. The stock sale proceeds are offset by costs of approximately $526,000, resulting in net
proceeds of approximately $4.6 million.
3. Short-term Investments
At December 31, 2007, short-term investments consisted of $2,448,447 of certificates of deposit
maturing in the fourth quarter of fiscal 2008.
4. Inventories
Inventories are stated at the lower of cost (first-in, first-out method) or market (net realizable
value). The reserve for slow moving and obsolete inventories was $59,000 and $229,000 at December
31, 2007 and March 31, 2007, respectively. Inventories, net of reserve, consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
|
March 31, 2007 |
|
Raw materials |
|
$ |
273,263 |
|
|
$ |
254,988 |
|
Work-in-process |
|
|
15,298 |
|
|
|
20,773 |
|
Finished goods |
|
|
544,210 |
|
|
|
547,840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
832,771 |
|
|
$ |
823,601 |
|
|
|
|
|
|
|
|
Page 8
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.
In April 2007, we acquired from CystoMedix, Inc. certain intellectual property assets related to
the Urgent PC system, which was previously licensed to us. In consideration, we issued CystoMedix
1,417,144 shares of our common stock. We have capitalized $4.7 million of the acquisition costs as
patents and inventions.
The following is a summary of intangible assets at December 31, 2007 and March 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
|
|
Estimated |
|
|
Gross |
|
|
|
|
|
|
|
|
|
Useful Lives |
|
|
Carrying |
|
|
Accumulated |
|
|
|
|
|
|
(Years) |
|
|
Amount |
|
|
Amortization |
|
|
Net value |
|
Licensed technology |
|
|
5 |
|
|
$ |
26,290 |
|
|
$ |
26,290 |
|
|
$ |
|
|
Patents and inventions |
|
|
6 |
|
|
|
5,463,774 |
|
|
|
1,037,673 |
|
|
|
4,426,101 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
|
|
|
|
$ |
5,490,064 |
|
|
$ |
1,063,963 |
|
|
$ |
4,426,101 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2007 |
|
Licensed technology |
|
|
5 |
|
|
$ |
26,290 |
|
|
$ |
26,290 |
|
|
$ |
|
|
Patents and inventions |
|
|
6 |
|
|
|
712,900 |
|
|
|
404,807 |
|
|
|
308,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
|
|
|
|
$ |
739,190 |
|
|
$ |
431,097 |
|
|
$ |
308,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated annual amortization for these assets for the fiscal years ended March 31 is as follows:
|
|
|
|
|
Remainder of fiscal 2008 |
|
$ |
211,564 |
|
2009 |
|
|
846,152 |
|
2010 |
|
|
843,869 |
|
2011 |
|
|
840,899 |
|
2012 |
|
|
840,500 |
|
Thereafter |
|
|
843,117 |
|
|
|
|
|
|
|
$ |
4,426,101 |
|
|
|
|
|
6. Deferred Rent and Leasehold Improvements
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
improvements. We recorded this incentive as deferred rent and are amortizing it as a 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. We are amortizing the
leasehold improvements over the shorter of the asset life or the lease term.
Page 9
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, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net loss |
|
$ |
(900,368 |
) |
|
$ |
(563,257 |
) |
|
$ |
(3,125,695 |
) |
|
$ |
(3,963,386 |
) |
Items of other
comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
97,349 |
|
|
|
77,297 |
|
|
|
276,378 |
|
|
|
155,394 |
|
Pension related |
|
|
(771 |
) |
|
|
(8,792 |
) |
|
|
(12,435 |
) |
|
|
(20,611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(803,790 |
) |
|
$ |
(494,752 |
) |
|
$ |
(2,861,752 |
) |
|
$ |
(3,828,603 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
8. Net Loss per Common Share
The following options and warrants outstanding at December 31, 2007 and 2006, 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 nine months ended: |
|
|
|
|
|
|
December 31, 2007
|
|
|
4,147,528 |
|
|
$1.82 to $5.30 |
December 31, 2006
|
|
|
4,953,679 |
|
|
$1.10 to $5.30 |
9. Warrants
As of December 31, 2007, we had issued and outstanding warrants to purchase an aggregate of
2,116,928 common shares, at a weighted average exercise price of $3.81.
In connection with our private equity offerings in April 2005 and August 2006 and our December 2006
follow-on public offering, we issued five-year warrants to purchase 1,180,928, 764,500 and 121,500
common shares, respectively, at exercise prices of $4.75, $2.50 and $2.40 per share, respectively.
As part of a consulting agreement, we have outstanding five-year warrants, issued in November 2003
to CCRI Corporation, to purchase 50,000 shares of common stock at a per share price of $5.00.
Proceeds from the exercise of warrants were $150,000 for the nine months ended December 31, 2007.
10. Share-based Compensation
As of December 31, 2007, we had one active plan (2006 Stock and Incentive Plan) for share-based
compensation grants. Under the plan, if we have a change in control, all outstanding grants,
including those subject to vesting or other performance targets, fully vest immediately. Under
this plan, we had reserved 1,200,000 shares of our common stock for stock-based grants, and as of
December 31, 2007, we had remaining 532,000 shares available for grant. We generally grant option
awards with an exercise price equal to the closing market price of our stock at the date of the
grant.
We account for share-based compensation costs under Statement of Financial Accounting Standards No.
123(R), Share-Based PaymentRevised 2004. We incurred a total of approximately $829,000 and
$588,000 in share-based compensation expense for the nine months ended December 31, 2007 and 2006,
respectively.
Proceeds from the exercise of stock options were $635,000 for the nine months ended December 31,
2007.
Page 10
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 following
periods:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, 2007 |
|
|
December 31, 2006 |
|
|
|
|
Expected life in years |
|
|
4.08 |
|
|
|
7.40 |
|
Risk-free interest rate |
|
|
4.57 |
% |
|
|
4.96 |
% |
Expected volatility |
|
|
91.88 |
% |
|
|
100.26 |
% |
Expected dividend yield |
|
|
0 |
|
|
|
0 |
|
Weighted-average fair value |
|
$ |
2.84 |
|
|
$ |
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. We
estimate a forfeiture rate for stock awards of up to 10.9% in 2008 based on the historical employee
turnover rates. The expected life of the options is based on the historical life of previously
granted options, which are generally held to maturity.
As of December 31, 2007, we had approximately $701,000 of unrecognized compensation cost related to
share-based payments that we expect to recognize over a weighted-average period of 1.41 years.
The following table summarizes the activity related to our stock options during the nine months
ended December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Avg. |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number of |
|
|
Avg. Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Price |
|
|
Life (Years) |
|
|
Value |
|
Options outstanding at beginning of period |
|
|
2,169,866 |
|
|
$ |
3.62 |
|
|
|
|
|
|
|
|
|
Options granted |
|
|
312,500 |
|
|
|
4.23 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(368,666 |
) |
|
|
1.72 |
|
|
|
|
|
|
|
|
|
Options surrendered |
|
|
(83,100 |
) |
|
|
4.66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at end of period |
|
|
2,030,600 |
|
|
$ |
4.01 |
|
|
|
5.11 |
|
|
$ |
1,349,450 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of period |
|
|
1,571,596 |
|
|
$ |
4.25 |
|
|
|
5.04 |
|
|
$ |
852,732 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 made no discretionary
contributions in association with these plans in the United States for the three- and nine-month
periods ended December 31, 2007. For the nine months ended December 31, 2006, we made a
contribution of $44,408, substantially all of which was in the form of our fully vested common
stock.
Our international subsidiaries have defined benefit retirement plans for eligible employees. These
plans provide benefits based on the employees years of service and compensation during the years
immediately preceding retirement, termination, disability, or death, as defined in the plans. We
froze the UK subsidiarys defined benefit plan on December 31, 2004 and established a defined
contribution plan on March 10, 2005. Effective April 1, 2005, we closed The Netherlands
subsidiarys defined benefit retirement plan for new participants and established a defined
contribution plan for new employees.
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-months ended December 31, 2007 and 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Gross service cost |
|
$ |
22,841 |
|
|
$ |
51,882 |
|
|
$ |
65,768 |
|
|
$ |
153,727 |
|
Interest cost |
|
|
23,837 |
|
|
|
31,355 |
|
|
|
69,232 |
|
|
|
92,710 |
|
Expected return on assets |
|
|
(17,560 |
) |
|
|
(18,017 |
) |
|
|
(51,029 |
) |
|
|
(53,224 |
) |
Amortization |
|
|
1,646 |
|
|
|
10,737 |
|
|
|
4,856 |
|
|
|
31,772 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic retirement cost |
|
$ |
30,764 |
|
|
$ |
75,957 |
|
|
$ |
88,827 |
|
|
$ |
224,985 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Major assumptions used in the above calculations include:
|
|
|
|
|
|
|
|
|
|
|
Nine |
|
|
Months Ended |
|
|
December 31, |
|
|
2007 |
|
2006 |
Discount rate |
|
|
4.90-5.30 |
% |
|
|
4.25-5.50 |
% |
Expected return on assets |
|
|
4.90-5.00 |
% |
|
|
4.00-5.00 |
% |
Expected rate of increase in future
compensation: |
|
|
|
|
|
|
|
|
General |
|
|
3 |
% |
|
|
3 |
% |
Individual |
|
|
0%-3 |
% |
|
|
0%-3 |
% |
We made contributions of approximately $381,000 and $6,000, respectively, during the nine-month
periods ended December 31, 2007 and 2006 to The Netherlands and to the United Kingdom defined
benefit pension plans. For the remainder of the fiscal year we expect to make approximately
$10,000 in additional contributions for the two plans.
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,
2007 and 2006, we recognized foreign currency (loss) gain of $(37,600) and $4,400, respectively.
For the nine months ended December 31, 2007 and 2006, we recognized foreign currency (loss) gain of
$(53,500) and $34,400, respectively.
13. Income Tax Expense
During the three months ended December 31, 2007 and 2006, our Dutch subsidiaries recorded income
tax expense of $3,000 and $44,800, respectively. During the nine months ended December 31, 2007
and 2006, our Dutch subsidiaries recorded income tax expense of $140,600 and $62,700, respectively.
During the three months ended December 31, 2007 and 2006, our U.S. organization recorded income
tax expense of $1,000 and $0, respectively. During the nine months ended December 31, 2007 and
2006, our U.S. organization recorded income tax expense of $1,300 and $0, respectively. We cannot
use our
Page 12
U.S. net operating loss carry forwards to offset taxable income in foreign jurisdictions.
Effective January 1, 2007, the maximum Dutch income tax rate is 25.5% for taxable income in excess
of 60,000.
Effective April 1, 2007, we adopted FASB Interpretation No. 48 (FIN 48), Accounting for
Uncertainty in Income Taxes an Interpretation of FASB Statement 109, which prescribes a
recognition threshold and a measurement attribute for financial statement recognition of tax
positions taken or expected to be taken in a tax return. It is managements responsibility to
determine whether it is more-likely than-not that a tax position will be sustained upon
examination, including resolution of any related appeals or litigation processes, based on the
technical merits of the position. At adoption on April 1, 2007, we had no unrecognized tax
benefits which needed adjustment. We reviewed all income tax positions taken or that we expect to
be taken for all open tax years and determined that our income tax positions are appropriately
stated and supported for all open years and that the adoption of FIN 48 did not have a significant
effect on our consolidated financial statements.
Under our accounting policies we would recognize interest and penalties accrued on unrecognized tax
benefits as well as interest received from favorable tax settlements within income tax expense. At
the adoption date of April 1, 2007, we recognized no interest or penalties related to uncertain tax
positions. As of December 31, 2007, we recorded no accrued interest or penalties related to
uncertain tax positions.
The fiscal tax years 2004 through 2007 remain open to examination by the Internal Revenue Service
and various state taxing jurisdictions to which we are subject. In addition, we are subject to
examination by certain foreign taxing authorities for which the fiscal years 2005 through 2007
remain open for examination.
We expect no significant change in the amount of unrecognized tax benefit, accrued interest or
penalties within the next 12 months.
14. Geographic Information
We are a medical device company that develops, manufactures and markets innovative proprietary
products for the treatment of voiding dysfunctions. Our primary focus is the commercialization of
our Urgent PC system, which we believe is the only FDA-approved non-surgical neurostimulation
therapy for the treatment of overactive bladder symptoms (OAB). We also offer Macroplastique, a
bulking agent for the treatment of urinary incontinence.
Based upon the above, we operate in only one reportable segment consisting of medical products,
primarily for the voiding dysfunctions market served primarily by urologists, urogynecologists and
gynecologists.
Page 13
Information regarding operations in different geographies for the three months ended December 31,
2007 and 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United |
|
The |
|
United |
|
|
|
|
|
|
States |
|
Netherlands |
|
Kingdom |
|
Eliminations * |
|
Consolidated |
Fiscal 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, three months
ended December 31,
2007 |
|
$ |
2,636,412 |
|
|
$ |
1,351,179 |
|
|
$ |
697,757 |
|
|
$ |
(956,034 |
) |
|
$ |
3,729,314 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense,
three months ended
December 31, 2007 |
|
|
1,000 |
|
|
|
3,004 |
|
|
|
|
|
|
|
|
|
|
|
4,004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss),
three months ended
December 31, 2007 |
|
|
(755,496 |
) |
|
|
4,001 |
|
|
|
(80,637 |
) |
|
|
(68,236 |
) |
|
|
(900,368 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets
At December 31, 2007 |
|
|
5,185,339 |
|
|
|
788,816 |
|
|
|
4,947 |
|
|
|
|
|
|
|
5,979,101 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, three months
ended December 31,
2006 |
|
$ |
737,391 |
|
|
$ |
1,586,040 |
|
|
$ |
531,876 |
|
|
$ |
(697,034 |
) |
|
$ |
2,158,273 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense,
three months ended
December 31, 2006 |
|
|
|
|
|
|
44,802 |
|
|
|
|
|
|
|
|
|
|
|
44,802 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss),
three months ended
December 31, 2006 |
|
|
(796,316 |
) |
|
|
145,649 |
|
|
|
128,873 |
|
|
|
(41,463 |
) |
|
|
(563,257 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets
At December 31, 2006 |
|
|
1,007,348 |
|
|
|
749,890 |
|
|
|
5,242 |
|
|
|
|
|
|
|
1,762,480 |
|
Information regarding operations in different geographies for the nine months ended December 31,
2007 and 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United |
|
The |
|
United |
|
|
|
|
|
|
States |
|
Netherlands |
|
Kingdom |
|
Eliminations * |
|
Consolidated |
Fiscal 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, nine months ended
December 31, 2007 |
|
$ |
5,840,807 |
|
|
$ |
4,569,333 |
|
|
$ |
1,861,670 |
|
|
$ |
(2,554,279 |
) |
|
$ |
9,717,531 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense,
nine months ended
December 31, 2007 |
|
|
1,300 |
|
|
|
140,644 |
|
|
|
|
|
|
|
|
|
|
|
141,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss), nine
months ended December
31, 2007 |
|
|
(3,241,509 |
) |
|
|
389,828 |
|
|
|
(233,776 |
) |
|
|
(40,238 |
) |
|
|
(3,125,695 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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,
nine months ended
December 31, 2006 |
|
|
|
|
|
|
62,713 |
|
|
|
|
|
|
|
|
|
|
|
62,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss), nine
months ended December
31, 2006 |
|
|
(4,151,691 |
) |
|
|
254,859 |
|
|
|
29,530 |
|
|
|
(96,084 |
) |
|
|
(3,963,386 |
) |
|
|
|
* |
|
The information in the column entitled Eliminations represents intercompany transactions. |
Page 14
15. Recently Issued Accounting Standards
In September 2006, the Financial Accounting Standards Board, or FASB, issued SFAS No. 157, Fair
Value Measurements (SFAS No. 157). SFAS No. 157 establishes a common definition for fair value to
be applied to US GAAP guidance requiring use of fair value, establishes a framework for measuring
fair value, and expands disclosure about such fair value measurements. SFAS No. 157 is effective
for fiscal years beginning after November 15, 2007. We are currently assessing the impact of SFAS
No. 157 but do not believe the adoption will have a significant impact on our financial position
and results of operations.
On February 15, 2007, the FASB, issued SFAS No. 159, The Fair Value Option for Financial Assets
and Financial Liabilities. Under SFAS No. 159, we may elect to report financial instruments and
certain other items at fair value on a contract-by-contract basis with changes in value reported in
earnings. This election is irrevocable. SFAS No. 159 provides an opportunity to mitigate
volatility in reported earnings caused by measuring hedged assets and liabilities that were
previously required to use a different accounting method than the related hedging contracts when
the complex hedge accounting provisions of SFAS No. 133, Accounting for Derivative Instruments and
Hedging Activities, are not met. SFAS No. 159 is effective for years beginning after November 15,
2007. If we adopt this standard, we do not expect it to have a material effect on our financial
statements.
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, 2007.
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 primary focus is the commercialization of
our Urgent PC system, which we believe is the only FDA-approved non-surgical neurostimulation
therapy for the treatment of overactive bladder (OAB) symptoms. We also offer Macroplastique, a
bulking agent for the treatment of urinary incontinence. We believe that physicians prefer our
products because they offer an effective therapy for the patient, can be administered in
office-based settings and, with reimbursement in place, provide the physicians a new profitable
recurring revenue stream. We believe that patients prefer our products because they are
non-surgical treatment alternatives that do not have the side effects associated with
pharmaceutical treatment options.
The Urgent PC neurostimulation system is a minimally invasive device designed for office-based
treatment of OAB symptoms of urge incontinence, urinary urgency and urinary frequency. The
treatment can be administered by qualified office-based staff under the supervision of a physician.
The Urgent PC system uses percutaneous tibial nerve stimulation to deliver an electrical pulse
that travels to the sacral nerve plexus, a control center for bladder function. We have received
regulatory approvals for sale of the Urgent PC system in the United States, Canada and Europe. We
launched sales of our second generation Urgent PC system in late 2006.
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 the use of Macroplastique to treat female stress
incontinence. We began marketing Macroplastique in the United States in early 2007.
We are focusing our sales and marketing efforts primarily on urologists, urogynecologists and
gynecologists with significant office-based and outpatient surgery-based patient volume. We
believe the United States is a significant opportunity for future
Page 16
sales of our products. In order to grow our United States business, we recently established a
sales organization, consisting of direct field sales personnel 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 OAB symptoms and incontinence.
Critical Accounting Policies
We prepare our consolidated financial statements in accordance with accounting principles
generally accepted in the U.S., 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 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
distributors purchase our products to meet the 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
were not substantially different than our sales to those distributors in each of the three- and
nine-month periods ended December 31, 2007 and 2006. 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 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 component of comprehensive
loss reflected as a separate item in shareholders equity.
Impairment of Long-Lived Assets. Long-lived assets at December 31, 2007 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 assets 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.
Page 17
Share-Based Compensation. FASB published Statement No. 123 (revised 2004), Share-Based Payment, or
SFAS 123(R). 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
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 arrangements including stock options,
restricted share plans, performance-based awards, share appreciation rights, and employee share
purchase plans.
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.
Defined Benefit Pension Plans. We have a liability attributed to defined benefit pension plans we
offered to certain former and current employees prior to April 2005. We pay premiums to an
insurance company to fund annuities and are responsible for funding additional annuities based on
continued service and future salary increases for these employees pension benefit. The liability
is dependent upon numerous factors, assumptions and estimates, and the continued benefit costs we
incur may be significantly affected by changes in key actuarial assumptions such as the discount
rate, compensation rates, or retirement dates used to determine the projected benefit obligation.
Additionally, changes made to the provisions of the plans may impact current and future benefit
costs. In accordance with accounting rules, we may not immediately recognize changes in benefit
obligations associated with these factors as costs on the income statement, but may recognize them
in future years over the remaining average service period of plan participants.
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 March 31, 2007, we have generated approximately $18
million 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 all or a portion of the deferred tax asset. We have established a
valuation allowance for all 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, future utilization of NOL carryforwards is subject to certain limitations under
Section 382 of the Internal Revenue Code. This section generally relates to a 50 percent change in
ownership of a company over a three-year period. We believe that the issuance of our common stock
in the December 2006 and November 2007 follow-on public offerings resulted in an ownership change
under Section 382. Accordingly, our ability to use NOL tax attributes generated prior to these
offerings will likely be limited.
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, 2007 and 2006. See Note 14 to our
condensed consolidated financial statements for geographic information.
Results of Operations
Three months ended December 31, 2007 compared to three months ended December 31, 2006
Net Sales: During the three months ended December 31, 2007, net sales of $3.7 million represented
a $1.6 million, or a 73% increase, over net sales of $2.2 million for the three months ended
December 31, 2006. Excluding the translation impact of fluctuations in foreign currency exchange
rates, sales increased by approximately 65%. We attribute this growth in sales to our customers in
the U.S. as a result of our expanded U.S. sales organization and the continued growth in sales of
our Urgent PC system.
Sales to customers in the U.S. in the three months ended December 31, 2007 increased to $2.0
million from $396,000 in the three months ended December 31, 2006. Sales for the three months
ended December 31, 2007, represent a sequential, quarter-to-quarter increase from $1.2 million in
the previous quarter. We attribute this growth primarily to the Urgent PC system and the expanded
sales organization. During the three months ended December 31, 2007, we had minimal sales of our
Macroplastique product in the U.S., which we launched in the U.S. early in 2007.
Sales to customers outside the U.S. for the three months ended December 31, 2007 and 2006 were $1.8
million in each period. Excluding the translation impact of fluctuations in foreign currency
exchange rates, sales declined by approximately 10%. We attribute the decline primarily to the
decline in sales of our Macroplastique-related products.
Page 18
Gross Profit: Gross profit was $2.9 million and $1.4 million for the three months ended December
31, 2007 and 2006, respectively, or 79% and 65% of net sales in the respective periods. In the
three months ended December 31, 2006 we incurred $107,000 of charges related to rework, scrap and
warranty for one of our new products and an estimated $60,000 of costs related to underutilization
of the manufacturing facility as we shifted production to the earlier quarter to accommodate the
manufacturing transition to the new facility and charges for duplicate facilities in the U.S. We
attribute the higher gross profit percentage in the three months ended December 31, 2007, to the
increase in manufacturing capacity utilization, savings of approximately $99,000 (offset by
$122,000 of rent and lease exit charges) due to the discontinuation of manufacturing at our
Eindhoven, The Netherlands facility. We also realized a favorable impact of approximately two
percentage points in gross margin during the 2007 period due to an increase in the average selling
price in the U.S. of the lead sets used with our Urgent PC system and a favorable product mix. We
estimate that, during the 2007 period, increased manufacturing capacity utilization, as a result of
increased sales, added approximately five to six percentage points to our gross margin.
General and Administrative Expenses (G&A): G&A expenses increased from $707,000 during the three
months ended December 31, 2006 to $799,000 during the same period in 2007. Included in the
three-month period ended December 31, 2006 is a $127,000 non-cash, SFAS 123 (R) charge for
share-based employee compensation, compared with a charge of $101,000 in the three-month period
ended December 31, 2007. Excluding share-based compensation charges, G&A expenses increased by
$118,000, primarily because of an increase in personnel-related costs and consulting fees primarily
related to Sarbanes-Oxley compliance.
Research and Development Expenses (R&D): R&D expenses increased from $425,000 during the three
months ended December 31, 2006 to $460,000 during the same period in 2007. We attribute the
increase primarily to increase in spending of $105,000 for clinical studies, partially offset by a
decrease in personnel-related costs of $44,000.
Selling and Marketing Expenses (S&M): S&M expenses increased from $1.3 million during the three
months ended December 31, 2006 to $2.4 million during the same period in 2007. We attribute the
increase to a $742,000 increase primarily for commissions to independent sales representatives and
compensation-related costs for our expanded sales organization, an $92,000 charge related to
severance expense, a $50,000 increase in costs to attend tradeshows, an $133,000 increase in travel
related costs, and an increase in other costs to support our expanded sales organization and
marketing activities.
Amortization of Intangibles: Amortization of intangibles increased from $25,000 during the three
months ended December 31, 2006 to $210,000 during the same period in 2007. In April 2007, we
acquired from CystoMedix, Inc., certain intellectual property assets related to the Urgent PC
system for $4.7 million. We began amortizing the intellectual property assets acquired over six
years starting in April 2007.
Other Income (Expense): Other income (expense) includes interest income, interest expense, warrant
expense, foreign currency exchange gains and losses and other non-operating costs when incurred.
Other income was $33,000 and $535,000 for the three months ended December 31, 2007 and 2006,
respectively, with $523,000 of the change resulting from a warrant benefit in the three months
ended December 31, 2006.
In May 2002, we conducted a public rights offering. In the rights offering, we issued to those
shareholders who exercised their rights three shares of our common stock and a warrant, exercisable
through July 2004, to purchase an additional share of our common stock. We registered with the SEC
the issuance of the shares, the warrants and the shares underlying the warrants. In July 2004, we
suspended the right to exercise the warrants shortly before their scheduled expiration date because
we announced a planned restatement of our fiscal 2004 financial statements. In November 2004, we
became current with our SEC filings. In April 2005, we chose to issue like-kind replacement
warrants to the holders of the expired warrants. The terms for the replacement warrants required
that we issue shares covered by a registration statement and maintain the effectiveness of the
registration (by making timely SEC filings) for the warrant holders to receive registered shares
upon exercise of the warrants. In April 2005, we recognized a liability and equity charge of $1.4
million associated with the grant of these warrants, and subsequently recognized in other income
(expense) the change in fair value of the warrants due to the change in the value of our common
stock issuable upon exercise of these warrants. We determined the fair value of the warrants using
the Black-Scholes option-pricing model. The period to exercise the warrants ended in March 2007.
We recognized a net warrant benefit of $523,000 in the quarter ended December 31, 2006.
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
(loss) gain of $(37,600) and $4,400 for the three months ended December 31, 2007 and 2006,
respectively.
Page 19
Income Tax Expense: During the three months ended December 31, 2007 and 2006, our Dutch
subsidiaries recorded income tax expense of $3,000 and $44,800, respectively. During the three
months ended December 31, 2007 and 2006, our U.S. organization recorded income tax expense of
$1,000 and $0, respectively. We cannot use our U.S. net operating loss carry forwards to offset
taxable income in foreign jurisdictions. Effective January 1, 2007, the maximum Dutch income tax
rate is 25.5% for taxable income in excess of 60,000.
Nine months ended December 31, 2007 compared to nine months ended December 31, 2006
Net Sales: During the nine months ended December 31, 2007, net sales of $9.7 million represented a
$4.0 million, or a 71% increase, over net sales of $5.7 million for the nine months ended December
31, 2006. Excluding the translation impact of fluctuations in foreign currency exchange rates,
sales increased by approximately 64%. We attribute this growth primarily to an increase in sales
to our customers in the U.S. as a result of our expanded U.S. sales organization, and the continued
growth in sales of our Urgent PC system.
Sales to customers in the U.S. increased to $4.2 million during the nine months ended December 31,
2007, from $752,000 in the same period last year. We attribute this growth primarily to the Urgent
PC system and the expanded sales organization. During the nine months ended December 31, 2007, we
had minimal sales of our Macroplastique product in the U.S., which we launched in the U.S. early in
2007, and the I-Stop product, which we discontinued.
Sales to customers outside the U.S. for the nine months ended December 31, 2007 were $5.5 million,
representing a $585,000 or 12% increase, compared to $4.9 million for the nine months ended
December 31, 2006. Excluding the translation impact of fluctuations in foreign currency exchange
rates, sales increased by approximately 4%. We attribute the increase primarily to the increase in
sales of our Macroplastique-related products.
Gross Profit: Gross profit was $7.7 million and $3.9 million for the nine months ended December
31, 2007 and 2006, respectively, or 79% and 69% of net sales in the respective periods. We
attribute the lower gross profit percentage for the nine months ended December 31, 2006 primarily
to the $107,000 of charges related to rework, scrap and warranty for one of our new products and an
estimated $72,000 of costs associated duplicate manufacturing facilities in the U.S. We attribute
the higher gross profit percentage for the nine months ended December 31, 2007 to the increase in
manufacturing capacity utilization, and savings of approximately $260,000 (offset by $122,000 of
rent and lease exit charges) due to the discontinuation of manufacturing at our Eindhoven, The
Netherlands facility. During the 2007 period, we also realized a favorable impact of
approximately one percentage point in gross margin due to an increase in the average selling price
in the U.S. of the lead sets used with our Urgent PC system and a favorable product mix. We
estimate that, during the 2007 period, the increased manufacturing capacity utilization, as a
result of increased sales, added approximately five percentage points to our gross margin.
General and Administrative Expenses (G&A): G&A expenses increased from $2.4 million during the
nine months ended December 31, 2006 to $2.8 million during the same period in 2007. Included in
the nine-month period ended December 31, 2006 is a $519,000 non-cash, SFAS 123 (R) charge for
share-based employee compensation, compared with a charge of $565,000 in the nine-month period
ended December 31, 2007. Excluding share-based compensation charges, G&A expenses increased by
$344,000, primarily because of an increase in personnel-related costs and consulting fees, offset
by a reduction in rent expense for our leased facilities in the United Kingdom and the U.S.
Research and Development Expenses (R&D): R&D expenses decreased from $1.8 million during the nine
months ended December 31, 2006 to $1.4 during the same period in 2007. We attribute the decrease
primarily to reduced consulting expense of $245,000 and a decrease in personnel-related costs of
$175,000. During the nine months ended December 31, 2006, we incurred consulting expense
associated with the development of our second generation Urgent PC system and preparation for a
clinical study.
Selling and Marketing Expenses (S&M): S&M expenses increased from $3.8 million during the nine
months ended December 31, 2006 to $6.0 million during the same period in 2007. We attribute the
increase primarily to a $1.5 million increase in commissions for independent sales representatives
and compensation-related costs for our expanded sales organization, an $92,000 charge related to
severance expense, a $131,000 increase in costs to attend tradeshows, a $201,000 increase in travel
related costs, and an increase in other costs to support our expanded sales organization and
marketing activities.
Amortization of Intangibles: Amortization of intangibles increased from $78,000 during the nine
months ended December 31, 2006 to $633,000 during the same period in 2007. In April 2007, we
acquired from CystoMedix, Inc., certain intellectual
Page 20
property assets related to the Urgent PC system for $4.7 million. We began amortizing the
intellectual property assets acquired over six years starting in April 2007.
Other Income (Expense): Other income (expense) includes interest income, interest expense, warrant
expense, foreign currency exchange gains and losses and other non-operating costs when incurred.
Other income was $140,000 and $217,000 for the nine months ended December 31, 2007 and 2006,
respectively, with $150,000 of the change resulting from a warrant benefit in the nine months ended
December 31, 2006.
In May 2002, we conducted a public rights offering. In the rights offering, we issued to those
shareholders who exercised their rights three shares of our common stock and a warrant, exercisable
through July 2004, to purchase an additional share of our common stock. We registered with the SEC
the issuance of the shares, the warrants and the shares underlying the warrants. In July 2004, we
suspended the right to exercise the warrants shortly before their scheduled expiration date because
we announced a planned restatement of our fiscal 2004 financial statements. In November 2004, we
became current with our SEC filings. In April 2005, we chose to issue like-kind replacement
warrants to the holders of the expired warrants. The terms for the replacement warrants required
that we issue shares covered by a registration statement and maintain the effectiveness of the
registration (by making timely SEC filings) for the warrant holders to receive registered shares
upon exercise of the warrants. In April 2005, we recognized a liability and equity charge of $1.4
million associated with the grant of these warrants, and subsequently recognized in other income
(expense) the change in fair value of the warrants due to the change in the value of our common
stock issuable upon exercise of these warrants. We determined the fair value of the warrants using
the Black-Scholes option-pricing model. The period to exercise the warrants ended in March 2007.
We recognized a net warrant benefit of $150,000 during the nine months ended December 31, 2006.
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 $(54,000) and $34,000 for the nine months ended December 31, 2007 and 2006,
respectively.
Income Tax Expense: During the nine months ended December 31, 2007 and 2006, our Dutch
subsidiaries recorded income tax expense of $140,600 and $62,700, respectively. During the nine
months ended December 31, 2007 and 2006, our U.S. organization recorded income tax expense of
$1,300 and $0, respectively. We cannot use our U.S. net operating loss carry forwards to offset
taxable income in foreign jurisdictions.
Non-GAAP Financial Measures. The following table reconciles our financial results calculated in
accordance with accounting principles generally accepted in the U.S. (GAAP) to non-GAAP financial
measures that exclude non cash charges attributed to stock options under SFAS 123 (R), and
deprecation and amortization expenses from gross profit, operating expenses and operating loss.
The non-GAAP financial measures used by management and disclosed by us are not a substitute for, or
superior to, financial measures and consolidated financial results calculated in accordance with
GAAP, and you should carefully evaluate our reconciliations to non-GAAP. 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.
Management uses our non-GAAP financial measures, and in particular non-GAAP operating loss, for
internal managerial purposes because we believe such measures are one important indicator of the
strength and the performance of our business because they provide a link to operating cash flow.
We also believe that analysts and investors use such measures to evaluate the overall operating
performance of companies in our industry, including as a means of comparing period-to-period
results and as a means of evaluating our results with those of other companies.
Our non-GAAP operating loss of approximately $466,000 and $1.5 million for the three and six months
ended December 31, 2007, respectively, declined from $820,000 and $3.3 million for the respective
prior year periods. Included in the three and nine months ended December 31, 2007 is a $214,000
charge attributed to rent and cost to exit the lease for our manufacturing facility in Eindhoven,
The Netherlands and severance pay. We attribute the decline in non-GAAP operating loss primarily
to the increase in sales and an improvement in gross margin rate, offset partially by an increase
in cash operating expenses.
Page 21
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Gross Profit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP gross profit |
|
$ |
2,939,359 |
|
|
$ |
1,406,092 |
|
|
$ |
7,664,323 |
|
|
$ |
3,922,700 |
|
% of sales |
|
|
79 |
% |
|
|
65 |
% |
|
|
79 |
% |
|
|
69 |
% |
SFAS 123 (R) stock option charges |
|
|
9,008 |
|
|
|
|
|
|
|
18,695 |
|
|
|
1,361 |
|
Depreciation expenses |
|
|
13,277 |
|
|
|
12,330 |
|
|
|
41,882 |
|
|
|
36,358 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP gross profit |
|
|
2,961,644 |
|
|
|
1,418,422 |
|
|
|
7,724,900 |
|
|
|
3,960,419 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP operating expenses |
|
|
3,868,656 |
|
|
$ |
2,459,060 |
|
|
$ |
10,787,959 |
|
|
$ |
8,040,105 |
|
SFAS 123 (R) stock option charges |
|
|
187,438 |
|
|
|
158,770 |
|
|
|
848,394 |
|
|
|
634,585 |
|
Depreciation expenses |
|
|
43,842 |
|
|
|
37,015 |
|
|
|
122,001 |
|
|
|
108,367 |
|
Amortization expenses |
|
|
209,862 |
|
|
|
25,210 |
|
|
|
632,865 |
|
|
|
78,323 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP operating expenses |
|
|
3,427,514 |
|
|
|
2,238,065 |
|
|
|
9,184,699 |
|
|
|
7,218,830 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP operating loss |
|
|
(929,297 |
) |
|
|
(1,052,968 |
) |
|
|
(3,123,636 |
) |
|
|
(4,117,405 |
) |
SFAS 123 (R) stock option charges |
|
|
196,446 |
|
|
|
158,770 |
|
|
|
867,089 |
|
|
|
635,946 |
|
Depreciation expenses |
|
|
57,119 |
|
|
|
49,345 |
|
|
|
163,883 |
|
|
|
144,725 |
|
Amortization expenses |
|
|
209,862 |
|
|
|
25,210 |
|
|
|
632,865 |
|
|
|
78,323 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP operating loss |
|
$ |
(465,870 |
) |
|
$ |
(819,643 |
) |
|
$ |
(1,459,799 |
) |
|
$ |
(3,258,411 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Liquidity and Capital Resources
Cash Flows.
As of December 31, 2007, our cash and cash equivalents balances totaled $7.9 million and our
short-term investments totaled $2.4 million.
At December 31, 2007, we had working capital of approximately $10.7 million. For the nine months
ended December 31, 2007, we used $1.6 million of cash in operating activities, compared to $3.3
million of cash used in the same period a year ago. We attribute the decrease in cash used in
operating activities primarily to the increase in sales and an improvement in gross profit rate,
offset partially by increase in cash operating expenses.
Sources of Liquidity.
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 $275,000, we received net
proceeds of approximately $1.8 million. The warrants are exercisable for five years (commencing
181 days after closing) at an exercise price of $2.50 per share.
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, resulting in net proceeds of approximately $4.3
million.
Page 22
In November 2007, we conducted an additional follow-on public offering in which we sold 1,466,400
shares of our common stock at price of $3.50 per share, for an aggregate purchase price of
approximately $5.1 million. The stock sale proceeds are offset by costs of approximately $526,000,
resulting in net proceeds of approximately $4.6 million.
For the nine months ended December 31, 2007, proceeds from exercise of warrants and options were
$785,000.
In May 2007, we amended our business loan agreement with Venture Bank. The agreement, expiring in
May 2008, provides for a credit line of up to $1 million secured by our assets. We may borrow up
to 50% (to a maximum of $500,000) of the value of our eligible inventory on hand in the U.S. and
80% of our eligible U.S. accounts receivable value. To borrow any amount, we must maintain
consolidated net equity of at least equal to $3.5 million as well as maintain certain other
financial covenants on a quarterly basis. The bank charges interest on the loan at a per annum
rate of the greater of 7.5% or one percentage point over the prime rate (7.25% prime rate on
December 31, 2007). In addition, Uroplasty BV, our subsidiary, entered into an agreement with
Rabobank of The Netherlands for a 500,000 (approximately $736,000) credit line. The bank charges
interest on the loan at the rate of one percentage point over the Rabobank base interest rate
(5.25% base rate on December 31, 2007), subject to a minimum interest rate of 3.5% per annum. At
December 31, 2007, we had no borrowings under any of our credit lines.
We believe we have sufficient liquidity to meet our needs over the next twelve months. However, we
may need to raise additional financing to support our operations and planned growth activities in
the future as we have yet to achieve profitability and generate positive cash flows. To achieve
profitability, we must generate substantially more revenue than we have this year or in prior
years. Our ability to achieve significant revenue growth will depend, in large part, on our
ability to achieve widespread market acceptance for our products and successfully expand our
business in the U.S., which we cannot guarantee will happen. If we are unable to raise the needed
funds, we may 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 2008, 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 2008, we will continue to incur significant expenses as we fund
our selling and marketing organization in the U.S. to market our products.
Under a 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 commitments, generally for periods less than twelve months, to purchase from various
vendors finished goods and manufacturing components under issued purchase orders.
We have a pension plan covering seven 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, and, effective March 2005, established a defined contribution plan that now
covers new employees.
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
we estimated at approximately $89,0000 over 12 months.
Page 23
Repayments of our contractual obligations as of December 31, 2007, consisting of royalties, notes
payable (inclusive of interest), and operating leases, are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Remainder |
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
|
|
|
|
|
of Fiscal |
|
|
2009 and |
|
|
2011 and |
|
|
2013 and |
|
|
|
Total |
|
|
2008 |
|
|
2010 |
|
|
2012 |
|
|
thereafter |
|
Minimum royalty payments |
|
$ |
153,000 |
|
|
$ |
13,500 |
|
|
$ |
108,000 |
|
|
$ |
31,500 |
|
|
$ |
|
|
Purchase order commitments |
|
|
433,058 |
|
|
|
253,723 |
|
|
|
179,335 |
|
|
|
|
|
|
|
|
|
Notes payable, including interest |
|
|
594,449 |
|
|
|
27,182 |
|
|
|
171,839 |
|
|
|
113,251 |
|
|
|
282,177 |
|
Operating lease commitments |
|
|
968,694 |
|
|
|
51,473 |
|
|
|
336,048 |
|
|
|
284,557 |
|
|
|
296,616 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
2,149,201 |
|
|
$ |
345,878 |
|
|
$ |
795,222 |
|
|
$ |
429,308 |
|
|
$ |
578,793 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 nine months ended December 31, 2007, 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 nine months ended December 31, 2007.
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.
|
|
|
|
|
|
UROPLASTY, INC.
|
|
Date: February 11, 2008 |
By: |
/s/ DAVID B. KAYSEN
|
|
|
David B. Kaysen |
|
|
President and Chief Executive Officer |
|
|
|
|
|
Date: February 11, 2008 |
By: |
/s/ MAHEDI A. JIWANI
|
|
|
Mahedi A. Jiwani |
|
|
Chief Financial Officer |
|
|
Page 26