10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
|
|
|
þ |
|
Quarterly Report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the Quarterly Period Ended September 30, 2008
|
|
|
o |
|
Transition Report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the Transition Period from to .
Commission File No. 000-20989
UROPLASTY, INC.
(Exact name of registrant as specified in its Charter)
|
|
|
|
|
Minnesota, U.S.A.
|
|
|
|
41-1719250 |
(State or other jurisdiction of
incorporation or organization)
|
|
|
|
(I.R.S. Employer
Identification No.) |
5420 Feltl Road
Minnetonka, Minnesota, 55343
(Address of principal executive offices)
(912) 426-6140
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the registrant 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, a non-accelerated filer, or a smaller reporting
company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
|
|
|
|
|
|
|
Large accelerated filer o
|
|
Accelerated filer o
|
|
Non-accelerated filer o
|
|
Smaller Reporting Company
þ |
|
|
|
|
(Do not check if a smaller reporting company) |
|
|
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
As of October 31, 2008 the registrant had 14,946,540 shares of common stock outstanding.
Table of Contents
INDEX
UROPLASTY INC. AND SUBSIDIARIES
Page 2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
September 30, 2008 |
|
|
|
|
|
|
(unaudited) |
|
|
March 31, 2008 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
3,675,592 |
|
|
$ |
3,880,044 |
|
Short-term investments |
|
|
5,349,105 |
|
|
|
6,266,037 |
|
Accounts receivable, net |
|
|
1,690,285 |
|
|
|
2,318,604 |
|
Income tax receivable |
|
|
34,445 |
|
|
|
50,841 |
|
Inventories |
|
|
527,460 |
|
|
|
558,657 |
|
Other |
|
|
359,598 |
|
|
|
244,517 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
11,636,485 |
|
|
|
13,318,700 |
|
|
|
|
|
|
|
|
|
|
Property, plant, and equipment, net |
|
|
1,546,601 |
|
|
|
1,638,953 |
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
3,778,949 |
|
|
|
4,200,890 |
|
|
|
|
|
|
|
|
|
|
Prepaid pension asset |
|
|
36,482 |
|
|
|
26,482 |
|
|
|
|
|
|
|
|
|
|
Deferred tax assets |
|
|
105,961 |
|
|
|
105,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
17,104,478 |
|
|
$ |
19,290,323 |
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 3
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
September 30, 2008 |
|
|
|
|
|
|
(unaudited) |
|
|
March 31, 2008 |
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Current maturities long-term debt |
|
$ |
|
|
|
$ |
84,879 |
|
Deferred rent current |
|
|
35,000 |
|
|
|
35,000 |
|
Accounts payable |
|
|
504,126 |
|
|
|
661,624 |
|
Accrued liabilities: |
|
|
|
|
|
|
|
|
Compensation |
|
|
952,034 |
|
|
|
1,471,950 |
|
Other |
|
|
339,260 |
|
|
|
486,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
1,830,420 |
|
|
|
2,739,933 |
|
|
|
|
|
|
|
|
|
|
Long-term debt less current maturities |
|
|
|
|
|
|
413,279 |
|
Deferred rent less current portion |
|
|
164,277 |
|
|
|
180,979 |
|
Accrued pension liability |
|
|
290,744 |
|
|
|
353,411 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
2,285,441 |
|
|
|
3,687,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Common stock
$.01 par value; 40,000,000 shares authorized, 14,946,540
shares issued and outstanding at
September 30, 2008 and
14,916,540 shares issued and
outstanding at March 31, 2008 |
|
|
149,465 |
|
|
|
149,165 |
|
Additional paid-in capital |
|
|
35,504,014 |
|
|
|
35,014,313 |
|
Accumulated deficit |
|
|
(20,802,842 |
) |
|
|
(19,835,230 |
) |
Accumulated other comprehensive
income (loss) |
|
|
(31,600 |
) |
|
|
274,473 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
14,819,037 |
|
|
|
15,602,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
17,104,478 |
|
|
$ |
19,290,323 |
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 4
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net sales |
|
$ |
3,920,516 |
|
|
$ |
3,039,543 |
|
|
$ |
8,446,138 |
|
|
$ |
5,988,217 |
|
Cost of goods sold |
|
|
549,199 |
|
|
|
669,041 |
|
|
|
1,257,166 |
|
|
|
1,263,253 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
3,371,317 |
|
|
|
2,370,502 |
|
|
|
7,188,972 |
|
|
|
4,724,964 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
918,394 |
|
|
|
1,147,432 |
|
|
|
1,957,108 |
|
|
|
1,955,806 |
|
Research and development |
|
|
327,978 |
|
|
|
426,997 |
|
|
|
733,498 |
|
|
|
933,122 |
|
Selling and marketing |
|
|
2,505,598 |
|
|
|
1,974,583 |
|
|
|
5,125,632 |
|
|
|
3,607,372 |
|
Amortization of intangibles |
|
|
210,966 |
|
|
|
206,482 |
|
|
|
421,941 |
|
|
|
423,003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,962,936 |
|
|
|
3,755,494 |
|
|
|
8,238,179 |
|
|
|
6,919,303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(591,619 |
) |
|
|
(1,384,992 |
) |
|
|
(1,049,207 |
) |
|
|
(2,194,339 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
63,542 |
|
|
|
65,239 |
|
|
|
138,656 |
|
|
|
141,622 |
|
Interest expense |
|
|
(6,750 |
) |
|
|
(9,279 |
) |
|
|
(13,585 |
) |
|
|
(20,644 |
) |
Foreign currency exchange gain (loss) |
|
|
5,038 |
|
|
|
(13,877 |
) |
|
|
(732 |
) |
|
|
(15,906 |
) |
Other, net |
|
|
(4,687 |
) |
|
|
|
|
|
|
(4,687 |
) |
|
|
1,880 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57,143 |
|
|
|
42,083 |
|
|
|
119,652 |
|
|
|
106,952 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(534,476 |
) |
|
|
(1,342,909 |
) |
|
|
(929,555 |
) |
|
|
(2,087,387 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
26,487 |
|
|
|
41,783 |
|
|
|
38,057 |
|
|
|
137,940 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(560,963 |
) |
|
$ |
(1,384,692 |
) |
|
$ |
(967,612 |
) |
|
$ |
(2,225,327 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share |
|
$ |
(0.04 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.17 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
14,916,540 |
|
|
|
13,342,284 |
|
|
|
14,916,540 |
|
|
|
13,162,862 |
|
See accompanying notes to the condensed consolidated financial statements.
Page 5
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS EQUITY AND COMPREHENSIVE LOSS
Six months ended September 30, 2008
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Shareholders |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Income (loss) |
|
|
Equity |
|
Balance at March
31, 2008 |
|
|
14,916,540 |
|
|
$ |
149,165 |
|
|
$ |
35,014,313 |
|
|
$ |
(19,835,230 |
) |
|
$ |
274,473 |
|
|
$ |
15,602,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
consulting and
compensation |
|
|
30,000 |
|
|
|
300 |
|
|
|
489,701 |
|
|
|
|
|
|
|
|
|
|
|
490,001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(967,612 |
) |
|
|
(306,073 |
) |
|
|
(1,273,685 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
September 30, 2008 |
|
|
14,946,540 |
|
|
$ |
149,465 |
|
|
$ |
35,504,014 |
|
|
$ |
(20,802,842 |
) |
|
$ |
(31,600 |
) |
|
$ |
14,819,037 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 6
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Six Months Ended September 30, 2008 and 2007
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(967,612 |
) |
|
$ |
(2,225,327 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
566,949 |
|
|
|
529,766 |
|
(Gain) Loss on disposal of equipment |
|
|
4,687 |
|
|
|
(2,771 |
) |
Share-based consulting expense |
|
|
36,409 |
|
|
|
26,005 |
|
Share-based compensation expense |
|
|
453,592 |
|
|
|
644,637 |
|
Deferred income taxes |
|
|
(10,164 |
) |
|
|
2,474 |
|
Deferred rent |
|
|
(17,500 |
) |
|
|
(17,500 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
537,959 |
|
|
|
(498,578 |
) |
Inventories |
|
|
(11,128 |
) |
|
|
(16,176 |
) |
Other current assets and income tax receivable |
|
|
(108,041 |
) |
|
|
64,660 |
|
Accounts payable |
|
|
(145,610 |
) |
|
|
190,508 |
|
Accrued liabilities |
|
|
(634,851 |
) |
|
|
(80,460 |
) |
Accrued pension liability, net |
|
|
(44,772 |
) |
|
|
(305,435 |
) |
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(340,082 |
) |
|
|
(1,688,197 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Proceeds from sale of short-term investments |
|
|
8,808,304 |
|
|
|
1,800,000 |
|
Purchase of short-term investments |
|
|
(7,891,373 |
) |
|
|
(1,200,000 |
) |
Purchases of property, plant and equipment |
|
|
(130,421 |
) |
|
|
(135,984 |
) |
Proceeds from sale of equipment |
|
|
|
|
|
|
4,417 |
|
Payments for intangible assets |
|
|
|
|
|
|
(89,725 |
) |
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
786,510 |
|
|
|
378,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from financing obligations |
|
|
|
|
|
|
178,374 |
|
Repayment of debt obligations |
|
|
(455,913 |
) |
|
|
(184,458 |
) |
Net proceeds from issuance of common stock, warrants and option exercise |
|
|
|
|
|
|
768,298 |
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
(455,913 |
) |
|
|
762,214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
(194,967 |
) |
|
|
93,320 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(204,452 |
) |
|
|
(453,955 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
3,880,044 |
|
|
|
3,763,702 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
3,675,592 |
|
|
$ |
3,309,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
13,612 |
|
|
$ |
17,024 |
|
Cash paid during the period for income taxes |
|
|
35,474 |
|
|
|
38,923 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash financing and investing activities: |
|
|
|
|
|
|
|
|
Purchase of intellectual property funded by issuance of stock |
|
$ |
|
|
|
$ |
4,658,861 |
|
See accompanying notes to the condensed consolidated financial statements.
Page 7
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-Q,
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 audited consolidated financial statements and related notes included in our Annual Report
on Form 10-K for the year ended March 31, 2008.
The condensed consolidated financial statements presented herein as of September 30, 2008 and for
the three and six-month periods ended September 30, 2008 and 2007 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-K for the year ended March 31,
2008. Based upon our review, we have determined that these policies remain our most critical
accounting policies for the three and six-month periods ended September 30, 2008, and we have made
no changes to these policies during fiscal 2009.
2. Short-term Investments
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.
3. Inventories
Inventories are stated at the lower of cost (first-in, first-out method) or market (net realizable
value). Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2008 |
|
|
March 31, 2008 |
|
Raw materials |
|
$ |
186,815 |
|
|
$ |
215,378 |
|
Work-in-process |
|
|
29,870 |
|
|
|
15,438 |
|
Finished goods |
|
|
310,775 |
|
|
|
327,841 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
527,460 |
|
|
$ |
558,657 |
|
|
|
|
|
|
|
|
We purchase several medical grade materials and other components for use in our finished products
from single source suppliers meeting our quality and other requirements. Although we believe our
supply sources could be replaced if necessary without due disruption, the process of qualifying new
suppliers could cause an interruption in our ability to manufacture our products, which could have
a negative impact on sales.
Page 8
4. Intangible Assets
Intangible Assets. Our intangible assets are comprised of patents and licensed technology which
we amortize on a straight-line basis over their estimated useful lives or contractual terms,
whichever is less.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2008 |
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
|
|
Estimated |
|
|
Carrying |
|
|
Accumulated |
|
|
|
|
|
|
Lives (Years) |
|
|
Amount |
|
|
Amortization |
|
|
Net value |
|
Licensed technology |
|
|
5 |
|
|
$ |
26,290 |
|
|
$ |
26,290 |
|
|
$ |
|
|
Patents and inventions |
|
|
6 |
|
|
|
5,449,230 |
|
|
|
1,670,281 |
|
|
|
3,778,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,475,520 |
|
|
$ |
1,696,571 |
|
|
$ |
3,778,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2008 |
|
Licensed technology |
|
|
5 |
|
|
$ |
26,290 |
|
|
$ |
26,290 |
|
|
$ |
|
|
Patents and inventions |
|
|
6 |
|
|
|
5,449,230 |
|
|
|
1,248,340 |
|
|
|
4,200,890 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,475,520 |
|
|
$ |
1,274,630 |
|
|
$ |
4,200,890 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In April 2007, we acquired from CystoMedix patents and certain intellectual property assets related
to the Urgent PC product and terminated the April 2005 exclusive manufacturing and distribution
agreement. In consideration, we issued CystoMedix 1,417,144 shares of common stock valued at
approximately $4.7 million. We have capitalized the consideration plus approximately $77,000 of
costs related to the transaction as patents and inventions.
Estimated annual amortization for these assets for the years ending March 31, is as follows:
|
|
|
|
|
Remainder of 2009 |
|
$ |
422,000 |
|
2010 |
|
|
840,000 |
|
2011 |
|
|
839,000 |
|
2012 |
|
|
839,000 |
|
2013 |
|
|
839,000 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,779,000 |
|
|
|
|
|
5. Deferred Rent and Leasehold Improvements
We entered into an 8-year operating lease agreement, effective May 2006, for our corporate facility
in Minnesota. 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
6. Comprehensive Loss
Comprehensive loss consists of net loss, translation adjustments and additional pension liability
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net loss |
|
$ |
(560,963 |
) |
|
$ |
(1,384,692 |
) |
|
$ |
(967,612 |
) |
|
$ |
(2,225,327 |
) |
Items of other
comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
(326,738 |
) |
|
|
156,903 |
|
|
|
(317,868 |
) |
|
|
179,030 |
|
Pension related |
|
|
11,774 |
|
|
|
(8,365 |
) |
|
|
11,795 |
|
|
|
(11,665 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(875,927 |
) |
|
$ |
(1,236,154 |
) |
|
$ |
(1,273,685 |
) |
|
$ |
(2,057,962 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other accumulated comprehensive income (loss) at September 30, 2008 totalled $(31,600) and consists
of $94,241 for accumulated translation adjustment and $(125,841) for accumulated additional pension
liability.
7. Net Loss per Common Share
The following restricted stock, options and warrants outstanding at September 30, 2008 and 2007, to
purchase shares of common stock, were excluded from diluted loss per common share because of their
anti-dilutive effect:
|
|
|
|
|
|
|
|
|
|
|
Number of Restricted |
|
|
Range of Exercise |
|
|
|
Stock/Options/Warrants |
|
|
Prices |
|
For the six months ended: |
|
|
|
|
|
|
|
|
September 30, 2008 |
|
|
4,340,361 |
|
|
$ |
1.82 to $5.30 |
|
September 30, 2007 |
|
|
4,119,578 |
|
|
$ |
1.82 to $5.30 |
|
8. Credit Facilities
In September 2008 we entered into a one-year business loan agreement with Venture Bank. The
agreement provides for a credit line of up to $2 million secured by the assets of our company. We
may borrow up to 50% (to a maximum of $500,000) of the value of our eligible inventory on hand and
80% of the value of our eligible U.S. accounts receivable; provided, however, our total
liabilities, inclusive of the amount borrowed, may not exceed our tangible net worth. To be
eligible to borrow any amount, we must maintain a minimum tangible net worth of $5 million.
Interest on the loan is charged at a per annum rate of the greater of 7.5% or one percentage point
over the prime rate (5.00 % prime rate on September 30, 2008). At September 30, 2008, we had no
borrowing outstanding on this credit line.
Uroplasty BV, our subsidiary, has an agreement for an indefinite term with Rabobank of The
Netherlands for a 500,000 (approximately $720,000) credit line. The bank charges interest on the
loan at the rate of one percentage point over the Rabobank base interest rate (5.85% base rate on
September 30, 2008), subject to a minimum interest rate of 3.5% per annum. At September 30, 2008,
we had no borrowings outstanding on this credit line.
9. Warrants
As of September 30, 2008, 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 the equity offerings of April 2005 private placement, August 2006 private
placement and December 2006 follow-on 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.
Page 10
Under a now expired consulting agreement for investor relations services with C.C.R.I. Corporation,
we have outstanding five-year warrants, expiring in November 2008, to purchase 50,000 of our shares
at an exercise price of $5.00 per share.
10. Share-based Compensation
As of September 30, 2008, we had one active plan (2006 Amended 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 2,700,000 shares of our common stock for share-based grants. On
September 18, 2008 our shareholders amended this plan to increase the number of reserved shares of
our common stock, and as of September 30, 2008, we had remaining 1,819,167 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 $490,000 and
$671,000 in share-based expense (inclusive of approximately $36,000 and $26,000, respectively, for
option grants to consultants) for the six months ended September 30, 2008 and 2007, respectively.
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:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, 2008 |
|
|
September 30, 2007 |
|
Expected life in years |
|
|
4.08 |
|
|
|
4.03 |
|
Risk-free interest rate |
|
|
3.16 |
% |
|
|
4.61 |
% |
Expected volatility |
|
|
82.76 |
% |
|
|
91.47 |
% |
Expected dividend yield |
|
|
0 |
|
|
|
0 |
|
Weighted-average fair value |
|
$ |
1.90 |
|
|
$ |
2.85 |
|
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 14% based on the historical employee turnover
rates.
The following table summarizes the activity related to our stock options for the six months ended
September 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Avg. |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number of |
|
|
Avg. Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Price |
|
|
Life (Years) |
|
|
Value |
|
Options outstanding at beginning of period |
|
|
2,038,100 |
|
|
$ |
4.01 |
|
|
|
|
|
|
$ |
|
|
Options granted |
|
|
232,000 |
|
|
|
3.05 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options cancelled |
|
|
(76,667 |
) |
|
|
3.93 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at end of period |
|
|
2,193,433 |
|
|
$ |
3.91 |
|
|
|
4.44 |
|
|
$ |
78,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of period |
|
|
1,877,178 |
|
|
$ |
4.01 |
|
|
|
4.46 |
|
|
$ |
78,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value represents the total pre-tax value of in-the-money options that
holders would realize based on an exercise price equal to the closing price of our Companys common
stock on September 30, 2008. As of September 30, 2008, we had approximately $520,400 of
unrecognized share-based compensation expense, net of estimated forfeitures, related to options
that we expect to recognize over a weighted-average period of 1.37 years.
Page 11
The following table summarizes the activity related to our restricted stock for the six months
ended September 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted Avg. |
|
|
|
|
|
|
|
|
|
|
Avg. Grant |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number of |
|
|
Date Fair |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Value |
|
|
Life (Years) |
|
|
Value |
|
Shares unvested at beginning of period |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
Shares granted |
|
|
30,000 |
|
|
|
3.11 |
|
|
|
|
|
|
|
|
|
Shares vested |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares cancelled |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares unvested at end of period |
|
|
30,000 |
|
|
$ |
3.11 |
|
|
|
0.38 |
|
|
$ |
93,220 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value represents the total pre-tax value of restricted stock that holders
would have received (based on the closing price of our Companys common stock on the grant date)
had all restricted stock vested and if we had issued common stock to the holders on the grant date.
As of September 30, 2008, we had $41,200 of total unrecognized compensation expense, net of
estimated forfeitures, related to restricted stock awards that we expect to recognize over a
weighted-average period of 0.38 years.
11. Savings and Retirement Plans
We sponsor various plans for eligible employees in the United States (U.S.), the United Kingdom
(UK), and The Netherlands. Our retirement savings plan in the U.S. 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 did not make any
contribution to the U.S. plan for the six months ended September 30, 2008 and 2007.
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. On March 10, 2005, we
established a defined contribution plan for the UK subsidiary. We closed The Netherlands
subsidiarys defined benefit retirement plan for new employees, as of April 1, 2005. On April 1,
2005, we established a defined contribution plan for new employees for The Netherlands subsidiary.
The cost for our defined benefit retirement plans in The Netherlands and the United Kingdom
includes the following components for the three and six-months ended September 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Gross service cost |
|
$ |
17,494 |
|
|
$ |
21,670 |
|
|
$ |
35,657 |
|
|
$ |
42,927 |
|
Interest cost |
|
|
24,778 |
|
|
|
22,910 |
|
|
|
50,518 |
|
|
|
45,395 |
|
Expected return on assets |
|
|
4,187 |
|
|
|
(16,891 |
) |
|
|
8,520 |
|
|
|
(33,469 |
) |
Amortization |
|
|
1,044 |
|
|
|
1,619 |
|
|
|
2,127 |
|
|
|
3,209 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic retirement cost |
|
$ |
47,503 |
|
|
$ |
29,308 |
|
|
$ |
96,822 |
|
|
$ |
58,062 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Page 12
Major assumptions used in the above calculations include:
|
|
|
|
|
|
|
|
|
|
|
Six |
|
|
|
Months Ended |
|
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
Discount rate |
|
|
6.10-6.70 |
% |
|
|
4.90-5.30 |
% |
Expected return on assets |
|
|
5.00-6.10 |
% |
|
|
4.90-5.00 |
% |
Expected rate of increase in future compensation:
|
|
|
|
|
|
|
|
|
General |
|
|
3 |
% |
|
|
3 |
% |
Individual |
|
|
0%-3 |
% |
|
|
0%-3 |
% |
The United Kingdom pension plan is in an over funded position and its funded status is shown as a
prepaid pension asset. The Netherlands pension plan is in an under funded position and its funded
status is shown as accrued pension liability.
We made aggregate contributions of approximately $144,000 and $371,000, respectively, for the six
months ended September 30, 2008 and 2007 to the two defined 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 income (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 September 30,
2008 and 2007, we recognized foreign currency exchange gain (loss) of $5,038 and $(13,877),
respectively. For the six months ended September 30, 2008 and 2007, we recognized foreign currency
exchange loss of $732 and $15,906, respectively.
13. Income Tax Expense
For the three months ended September 30, 2008 and 2007, our Dutch subsidiary recorded income tax
expense of $26,487 and $41,783, respectively. For the six months ended September 30, 2008 and
2007, our Dutch subsidiary recorded income tax expense of $38,057 and $137,640, respectively. We
cannot use our U.S. net operating loss carry forwards to offset taxable income in foreign
jurisdictions. Effective January 1, 2008, the maximum Dutch income tax rate is 25.5% for taxable
income in excess of 200,000.
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 we take or expect to take in a tax return. It is managements responsibility to
determine whether it is more-likely-than-not that a taxing authority will sustain a tax position
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
take for all open tax years and determined that our income tax positions are appropriately stated
and supported for all open years. Accordingly, 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 September 30, 2008, we recorded no accrued interest or penalties related to
uncertain tax positions.
Page 13
The fiscal tax years 2004 through 2008 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 2003 through 2008
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. Recently Issued Accounting Standards
In December 2007, the FASB issued SFAS 141(R), Business Combinations, which requires the
acquiring entity in a business combination to recognize and measure all assets and liabilities
assumed in the transaction and any non-controlling interest in the acquiree at fair value as of the
acquisition date. SFAS 141(R) also establishes guidance for the measurement of the acquirer shares
issued in consideration for a business combination, the recognition of contingent consideration,
the accounting treatment of pre-acquisition gain and loss contingencies, the treatment of
acquisition related transaction costs and the recognition of changes in the acquirers income tax
valuation allowance and deferred taxes. SFAS 141(R) is effective for fiscal years beginning after
December 15, 2008 and is applied prospectively as of the beginning of the fiscal year in which the
statement is applied. Early adoption is not permitted.
In December 2007, the FASB issued SFAS 160, Noncontrolling Interest in Consolidated Financial
Statements An Amendment of ARB 51, which establishes accounting and reporting standards that
require reporting of noncontrolling interests as a component of equity. SFAS 160 also requires
that a parent account as equity transactions, changes in ownership interest while it retains its
controlling interest. SFAS 160 further requires that a parent initially measure at fair value any
retained noncontrolling equity investment upon the deconsolidation of a subsidiary. SFAS 160 is
effective for fiscal years beginning after December 15, 2008 and is applied prospectively as of the
beginning of the fiscal year in which the statement is applied.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements", which defines fair
value, establishes a framework for measuring fair value under generally accepted accounting
principles, and expands disclosure about fair value measurements. In February 2007, the FASB
issued SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities", which
permits entities to choose to measure many financial instruments and certain other items at fair
value. SFAS 157 and SFAS 159 were effective beginning with our current quarter. The adoption of
these two statements did not have an impact on our financial position or results of operations.
ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
We recommend that you read this Report on Form 10-Q in conjunction with our Annual Report on Form
10-K for the year ended March 31, 2008.
Forward-looking Statements
This Form 10-Q contains forward-looking statements relating to projections, plans, objectives,
estimates, and other statements of future economic performance. These 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. Our business
operates in highly competitive markets and is subject to changes in general economic conditions,
competition, reimbursement levels, 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 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.
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 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
Page 14
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-K for the year
ended March 31, 2008. Based upon our review, we have determined that these policies remain our
most critical accounting policies for the six month period ended September 30, 2008, and we have
made no changes to these policies during fiscal 2009.
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 continued
commercialization of our Urgent PC system, which we believe is the only FDA-approved minimally
invasive, office-based neurostimulation therapy for the treatment of urinary urgency, urinary
frequency, and urge incontinence symptoms often associated with overactive bladder (OAB). We
also offer Macroplastique, a urethral bulking agent for the treatment of adult female stress
urinary incontinence primarily due to intrinsic sphincter deficiency (ISD). We believe physicians
prefer our products because they offer an effective therapy for the patient, can be administered in
office-based settings and, to the extent reimbursement is in place, provide the physicians a new
profitable recurring revenue stream. We believe patients prefer our products because they are
minimally invasive treatment alternatives and they do not have the side effects associated with
pharmaceutical treatment options.
Our net sales have increased significantly during the first six months ended September 30, 2008
over the corresponding year ago period, as our UrgentPC System has begun to be adopted by a larger
number of physicians in the United States. We have also realized increased sales of our
Macroplastique product, which we introduced in the U.S. market in late 2007. With the growth in
our Urgent PC sales and the benefit of increased manufacturing capacity utilization, we have
realized increased gross margins. Although we have incurred increased sales and marketing
expenses, primarily to support the growth in our U.S. business, the increased sales and the
improvement in gross margins, together with relatively stable general and administrative expenses
and decrease in research and development expenses, have allowed us to significantly decrease our
net loss in the past six months.
During the past few months, our Urgent PC sales in the U.S. have moderated, primarily because of
reimbursement related issues for Urgent PC treatments . The American Medical Association has
advised the medical community that their previously recommended listed CPT code for reimbursement
of Urgent PC treatments be replaced with an unlisted code. Some third-party insurance carriers
are now reassessing their coverage and reimbursement policies for Urgent PC treatments. However,
many other third party payors, including Aetna, under its national policy, and several local Blue
Cross/Blue/Shield plans across the U.S., as well as many other carriers on a case-by-case basis,
continue to cover Urgent PC treatments. We are working with third party payors to clarify the
reimbursement process and have commissioned an additional clinical study that we anticipate may
assist in obtaining the specific listed CPT code that will encourage broader use of our Urgent
PC. We anticipate spending $1.0 million to $1.4 million for this clinical study, substantially all
of it in the second half of our current fiscal year.
Results of Operations
Three months ended September 30, 2008 compared to three months ended September 30, 2007
Net Sales: During the three months ended September 30, 2008, net sales of $3.9 million represented
a $0.9 million or a 29% increase over net sales of $3.0 million for the three months ended
September 30, 2007. Excluding the translation impact of fluctuations in foreign currency exchange
rates, sales increased by approximately 27%. 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 growth in sales of our Urgent
PC system.
Sales to customers in the U.S. in the three months ended September 30, 2008 of $2.2 million
increased 83% from $1.2 million in the three months ended September 30, 2007. We attribute this
growth primarily to the Urgent PC system and the expanded sales organization. During the three
months ended September 30, 2008, we had sales of $254,000 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 September 30, 2008 and 2007 were
$1.7 and $1.8 million, respectively, a decrease of 7%. Excluding the translation impact of
fluctuations in foreign currency exchange rates, sales decreased by approximately 10%. We
attribute the decrease primarily to a decrease in sales of our Macroplastique-related and I-Stop
products, offset by an increase in sales of our the Urgent PC system.
Page 15
Gross Profit: Gross profit was $3.4 million and $2.4 million for the three months ended September
30, 2008 and 2007, respectively, or 86% and 78% of net sales in the respective periods. We
attribute the higher gross profit percentage in the three months ended September 30, 2008 primarily
to the favorable product mix, cost reductions and an increase in the average selling price
attributed to our Urgent PC system, as well as to higher manufacturing capacity utilization.
General and Administrative Expenses (G&A): G&A expenses decreased from $1.1 million during the
three months ended September 30, 2007 to $0.9 million during the same period in 2008. Included in
the three-month period ended September 30, 2007 is a $370,000 non-cash, SFAS 123 (R) charge for
share-based employee compensation, compared with a charge of $94,000 in the three-month period
ended September 30, 2008. Excluding share-based compensation charges, G&A expenses increased by
$47,000.
Research and Development Expenses (R&D): R&D expenses decreased from $427,000 during the three
months ended September 30, 2007 to $328,000 during the same period in 2008. We attribute the
decrease primarily to a decrease in personnel-related costs, a $25,000 decrease in SFAS 123 (R)
non-cash charges for share-based employee compensation, and a $65,000 decrease in spending for
clinical studies and related consulting expense. We expect our R&D spending to increase from our
current level as we ramp up for a new clinical study.
Selling and Marketing Expenses (S&M): S&M expenses increased from $2.0 million during the three
months ended September 30, 2007 to $2.5 million during the same period in 2008. We attribute the
increase primarily to a $424,000 increase in commissions to independent sales representatives and
compensation-related costs for our expanded sales organization, a $82,000 increase in travel
related costs, an increase in other costs to support our expanded sales organization and marketing
activities and a $69,000 charge for severance pay, offset by a $94,000 decrease in costs to attend
tradeshows.
Amortization of Intangibles: Amortization expenses of intangibles were $211,000 and $206,000 during
the three months ended September 30, 2008 and 2007, respectively. In April 2007, we acquired from
CystoMedix, Inc., certain intellectual property assets related to the Urgent PC system for $4.7
million, which we are amortizing over six years.
Other Income (Expense): Other income (expense) includes interest income, interest expense, foreign
currency exchange gains and losses and other non-operating costs when incurred. Net other income
was $57,000 and $42,000 for the three months ended September 30, 2008 and 2007, respectively.
We recognize foreign currency 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 exchange gain (loss) of $5,000 and $(14,000) for the three months ended September 30, 2008
and 2007, respectively.
Income Tax Expense: During the three months ended September 30, 2008 and 2007, our Dutch
subsidiary recorded income tax expense of $26,000 and $42,000, respectively. We cannot use our
U.S. net operating loss carry forwards to offset taxable income in foreign jurisdictions.
Effective January 1, 2008, the maximum Dutch income tax rate is 25.5% for taxable income in excess
of 200,000.
Six months ended September 30, 2008 compared to six months ended September 30, 2007
Net Sales: During the six months ended September 30, 2008, net sales were $8.4 million,
representing a $2.5 million or a 41% increase compared to net sales of $6.0 million for the six
months ended September 30, 2007. Excluding the translation impact of fluctuations in foreign
currency exchange rates, sales increased by approximately 36%. We attribute the vast majority of
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. Also, in the six months
ended September 30, 2008, sales of our Macroplastique product increased, which we attribute to our
increased marketing focus in the U.S.
Sales to customers in the U.S. increased to $4.4 million during the six months ended September 30,
2008, from $2.2 million in the same period last year. We attribute this growth primarily to the
Urgent PC system and the expanded sales organization. During the six months ended September 30,
2008, we had sales of $441,000 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 six months ended September 30, 2008 were $4.0 million,
representing a $0.3 million or 7% increase, compared to $3.8 million for the six months ended
September 30, 2007. Excluding the translation impact of fluctuations in foreign currency exchange
rates, sales decreased by approximately 1%.
Page 16
Gross Profit: Gross profit was $7.2 million and $4.7 million for the six months ended September
30, 2008 and 2007, respectively, or 85% and 79% of net sales in the respective periods. We
attribute the higher gross profit percentage in the six months ended September 30, 2008 primarily
to the favorable product mix, cost reductions and an increase in the average selling price
attributed to our Urgent PC system, as well as to higher manufacturing capacity utilization.
General and Administrative Expenses (G&A): G&A expenses were $2.0 million during the six months
ended September 30, 2008 and 2007. Included in the six-month period ended September 30, 2007 is a
$464,000 non-cash, SFAS 123 (R) charge for share-based employee compensation, compared with a
charge of $217,000 in the six-month period ended September 30, 2008. Excluding share-based
compensation charges, G&A expenses increased by $247,000, primarily because of an increase in
personnel-related costs.
Research and Development Expenses (R&D): R&D expenses decreased from $933,000 during the six
months ended September 30, 2007 to $733,000 during the same period in 2008. We attribute the
decrease primarily to a decrease in personnel-related costs, and a decrease in spending of $111,000
for clinical studies and related consulting expense. We expect our R&D spending to increase from
our current level as we ramp up for a new clinical study.
Selling and Marketing Expenses (S&M): S&M expenses increased from $3.6 million during the six
months ended September 30, 2007 to $5.1 million during the same period in 2008. We attribute the
increase to a $665,000 increase in compensation-related costs, primarily as a result of increased
salaries and bonuses, a $270,000 increase in commissions for sales agents and independent sales
representatives, a $69,000 charge for severance pay, and an increase in other costs to support our
expanded sales organization and marketing activities.
Amortization of Intangibles: Amortization expenses of intangibles were $422,000 and $423,000
during the six months ended September 30, 2008 and 2007, respectively. 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, foreign
currency exchange gains and losses and other non-operating costs when incurred. Net other income
was $120,000 and $107,000 for the six months ended September 30, 2008 and 2007, respectively.
We recognize foreign currency 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 exchange losses of $1,000 and $16,000 for the six months ended September 30, 2008 and
2007, respectively.
Income Tax Expense: During the six months ended September 30, 2008 and 2007, our Dutch
subsidiaries recorded income tax expense of approximately $38,000 and $138,000, respectively. We
cannot use our U.S. net operating loss carry forwards to offset taxable income in foreign
jurisdictions. Effective January 1, 2008, the maximum Dutch income tax rate is 25.5% for taxable
income in excess of 200,000.
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 for share-based compensation under SFAS 123 (R), and
depreciation 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 as 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.
Page 17
Our non-GAAP operating performance improved from a loss of approximately $616,000 and $994,000,
respectively, for the three and six months ended September 30, 2007 to a (loss) gain of
approximately ($98,000) and $8,000, respectively, for the three and six months ended September 30,
2008. We attribute this improvement in non-GAAP operating performance to the increase in sales and
an improvement in gross margin rate, offset partially by an increase in cash operating expenses.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Gross Profit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP gross profit |
|
|
3,371,317 |
|
|
$ |
2,370,502 |
|
|
|
7,188,972 |
|
|
$ |
4,724,964 |
|
% of sales |
|
|
86 |
% |
|
|
78 |
% |
|
|
85 |
% |
|
|
79 |
% |
SFAS 123 (R) share-based
compensation |
|
|
8,879 |
|
|
|
9,107 |
|
|
|
25,253 |
|
|
|
9,686 |
|
Depreciation expenses |
|
|
13,057 |
|
|
|
13,054 |
|
|
|
25,847 |
|
|
|
28,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP gross profit |
|
|
3,393,253 |
|
|
|
2,392,663 |
|
|
|
7,240,072 |
|
|
|
4,763,254 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP operating expenses |
|
|
3,962,936 |
|
|
|
3,755,494 |
|
|
|
8,238,179 |
|
|
$ |
6,919,303 |
|
SFAS 123 (R) share-based
compensation |
|
|
198,131 |
|
|
|
494,449 |
|
|
|
464,748 |
|
|
|
660,956 |
|
Depreciation expenses |
|
|
62,104 |
|
|
|
46,379 |
|
|
|
119,161 |
|
|
|
78,159 |
|
Amortization expenses |
|
|
210,966 |
|
|
|
206,482 |
|
|
|
421,941 |
|
|
|
423,003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP operating expenses |
|
|
3,491,735 |
|
|
|
3,008,184 |
|
|
|
7,232,329 |
|
|
|
5,757,185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP operating loss |
|
|
(591,619 |
) |
|
|
(1,384,992 |
) |
|
|
(1,049,207 |
) |
|
|
(2,194,339 |
) |
SFAS 123 (R) share-based
compensation |
|
|
207,010 |
|
|
|
503,556 |
|
|
|
490,001 |
|
|
|
670,642 |
|
Depreciation expenses |
|
|
75,161 |
|
|
|
59,433 |
|
|
|
145,008 |
|
|
|
106,763 |
|
Amortization expenses |
|
|
210,966 |
|
|
|
206,482 |
|
|
|
421,941 |
|
|
|
423,003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP operating gain (loss) |
|
|
(98,482 |
) |
|
$ |
(615,521 |
) |
|
|
7,743 |
|
|
$ |
(993,931 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Liquidity and Capital Resources
Cash Flows.
At September 30, 2008, our cash and cash equivalent and short-term investments balances totaled
$9.0 million.
At September 30, 2008, we had working capital of approximately $9.8 million. For the six months
ended September 30, 2008, we used $340,000 of cash in operating activities, compared to $1.7
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 an increase in cash operating expenses.
For the six months ended September 30, 2008 we used approximately $130,000 to purchase property,
plant and equipment compared with approximately $136,000 for the same period a year ago.
For the six months ended September 30, 2008 we used approximately $456,000 for financing activities
(retirement of debt), while for the same period a year ago we generated approximately $762,000,
primarily because of approximately $768,000 we generated from exercise of warrants and options.
Page 18
Sources of Liquidity.
In September 2008 we entered into a business loan agreement with Venture Bank. The agreement
provides for a credit line of up to $2 million secured by the assets of our company. We may borrow
up to 50% (to a maximum of $500,000) of the value of our eligible inventory on hand and 80% of the
value of our eligible U.S. accounts receivable; provided, however, our total liabilities, inclusive
of the amount borrowed, may not exceed our tangible net worth. To be eligible to borrow any
amount, we must maintain a minimum tangible net worth of $5 million. Interest on the loan is
charged at a per annum rate of the greater of 7.5% or one percentage point over the prime rate
(5.00 % prime rate on September 30, 2008). At September 30, 2008, we had no borrowing outstanding
on this credit line.
Uroplasty BV, our subsidiary, has an agreement with Rabobank of The Netherlands for a 500,000
(approximately $720,000) credit line. The bank charges interest on the loan at the rate of one
percentage point over the Rabobank base interest rate (5.85% base rate on September 30, 2008),
subject to a minimum interest rate of 3.5% per annum. At September 30, 2008, we had no borrowings
outstanding on this credit line.
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.
Commitments and Contingencies.
We expect to continue to incur significant costs for clinical studies to support the marketing of
our products and for regulatory activities associated with the FDA-required, post-market studies in
the United States for the Macroplastique product. We also expect that during the remainder of
fiscal 2009, we will continue to incur significant expenses to support our U.S. selling and
marketing organization.
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 defined benefit pension plan covering seven employees in The Netherlands. 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 us to pay annual operating
expenses that we estimate to be $89,000 each year.
Page 19
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk
Foreign Currency Risk
Due to the global nature of our operations, we are subject to exposures resulting from foreign
currency exchange fluctuations in the normal course of business. Our primary exchange rate
exposures are with the Euro and the British pound. The direct financial impact of foreign currency
exchange includes the effect of translating profits from local currencies to U.S. dollars, the
impact of currency fluctuations on the transfer of goods between our operations in the United
States and abroad and transaction gains and losses. In addition to the direct financial impact,
foreign currency exchange has an indirect financial impact on our results, including the effect on
sales volumes within local economies and the impact of any pricing actions taken as a result of
foreign exchange rate fluctuations. Because our products are currently manufactured or sourced
primarily from the United States, a stronger dollar generally has a negative impact on results from
operations outside the United States, while a weaker dollar generally has a positive effect. We
could experience favorable or unfavorable foreign exchange effects for the remainder of our current
fiscal year, compared with prior year results.
Other Matters
Management regularly reviews our business operations, processes and overall organizational
structure with the objective of improving our financial performance. As a result of this ongoing
process to improve financial performance, we may incur restructuring charges in the future which,
if taken, could be material to our financial results.
ITEM 4. Controls and Procedures
(a) Evaluation of Disclosure Controls Procedures. Under the supervision and with the
participation of our management, including, our President and Chief Executive Officer and Chief
Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure
controls and procedures (as defined in Rule 13a-15(e)) under the Securities Exchange Act of 1934
(the Exchange Act). Based on this evaluation, our Chief Executive Officer and Chief Financial
Officer concluded that, as of the end of the period covered by this report, our disclosure controls
and procedures are effective in ensuring that the information required to be disclosed by us in the
reports that we file or submit under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in applicable rules and forms and that such information
is accumulated and communicated to our management, including our Chief Executive Officer and Chief
Financial Officer, in a manner that allows timely decisions regarding required disclosure.
(b) Changes in Internal Controls. 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 were no changes in our
internal controls over financial reporting during the three months ended September 30, 2008, 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
ITEM 1. Legal Proceedings
None.
ITEM 1A. Risk Factors
The discussion of our business and operations should be read together with the risk factors
contained in Item 1A of our Annual Report on Form 10-K for the fiscal year ended March 31, 2008
filed with the Securities and Exchange Commission, which describe various risks and uncertainties
to which we are or may become subject. These risks and uncertainties have the potential to affect
our business, financial condition, results of operations, cash flows, strategies or prospects in a
material and adverse manner.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
ITEM 3. Defaults upon Senior Securities
None.
ITEM 4. Submission of Matters to a Vote of Security Holders
On September 18, 2008 we held our 2008 Annual Meeting. At the meeting the shareholders approved
(i) a proposal to reelect as directors Sven A. Wehrwein and R. Patrick Maxwell to three-year terms
expiring on the date of our 2011 annual shareholders meeting, and (ii) an amendment to our 2006
stock and incentive plan increasing the number of common shares reserved for issuance thereunder by
1,500,000. A summary of the voting is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Votes |
|
Votes |
|
Votes |
|
|
|
|
|
Broker |
|
|
For |
|
Against |
|
Withheld |
|
Abstentions |
|
Non-Votes |
Proposal 1 Election of
Directors: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sven A. Wehrwein |
|
|
12,263,415 |
|
|
|
|
|
|
|
1,385,744 |
|
|
|
|
|
|
|
382,088 |
|
R. Patrick Maxwell |
|
|
13,471,675 |
|
|
|
|
|
|
|
177,484 |
|
|
|
|
|
|
|
382,088 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proposal 2 Amendment
of the 2006 Stock and
Incentive Plan: |
|
|
6,697,556 |
|
|
|
2,652,079 |
|
|
|
|
|
|
|
30,065 |
|
|
|
4,650,577 |
|
ITEM 5. Other Information
None.
ITEM 6. Exhibits
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: November 3, 2008
|
|
By:
|
|
/s/ DAVID B. KAYSEN
|
|
|
|
|
David B. Kaysen |
|
|
|
|
President and Chief Executive Officer |
|
|
|
|
|
|
|
|
|
Date: November 3, 2008
|
|
By:
|
|
/s/ MAHEDI A. JIWANI |
|
|
|
|
|
|
|
|
|
|
|
Mahedi A. Jiwani |
|
|
|
|
Chief Financial Officer |
|
|
Page 22