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 September 30, 2006
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 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 October 24, 2006 was 8,411,188.
Transitional Small Business Disclosure Format:
YES o NO þ
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
September 30, 2006 |
|
|
|
|
|
|
(unaudited) |
|
|
March 31, 2006 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
1,983,303 |
|
|
$ |
1,563,433 |
|
Short-term investments |
|
|
|
|
|
|
1,137,647 |
|
Accounts receivable, net |
|
|
1,123,388 |
|
|
|
716,587 |
|
Income tax receivable |
|
|
195,348 |
|
|
|
270,934 |
|
Inventories |
|
|
1,026,045 |
|
|
|
757,062 |
|
Other |
|
|
327,502 |
|
|
|
353,178 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
4,655,586 |
|
|
|
4,798,841 |
|
|
|
|
|
|
|
|
|
|
Property, plant, and equipment, net |
|
|
1,425,102 |
|
|
|
1,079,438 |
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
358,491 |
|
|
|
411,604 |
|
|
|
|
|
|
|
|
|
|
Deferred tax assets |
|
|
159,743 |
|
|
|
111,361 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
6,598,922 |
|
|
$ |
6,401,244 |
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 2
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
September 30, 2006 |
|
|
|
|
|
|
(unaudited) |
|
|
March 31, 2006 |
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Current maturities long-term debt |
|
$ |
43,640 |
|
|
$ |
41,658 |
|
Deferred
rent current |
|
|
35,000 |
|
|
|
|
|
Notes payable |
|
|
64,050 |
|
|
|
|
|
Accounts payable |
|
|
734,457 |
|
|
|
506,793 |
|
Accrued liabilities |
|
|
799,275 |
|
|
|
917,981 |
|
Warrant liability |
|
|
1,038,036 |
|
|
|
665,356 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,714,458 |
|
|
|
2,131,788 |
|
|
|
|
|
|
|
|
|
|
Long-term debt less current maturities |
|
|
450,000 |
|
|
|
389,241 |
|
Deferred rent less current portion |
|
|
231,082 |
|
|
|
|
|
Accrued pension liability |
|
|
641,598 |
|
|
|
473,165 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
4,037,138 |
|
|
|
2,994,194 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Common stock $.01 par value;
20,000,000
shares authorized, 8,411,188 and
6,937,786 shares issued and
outstanding at September 30 and
March 31, 2006, respectively |
|
|
84,112 |
|
|
|
69,378 |
|
Additional paid-in capital |
|
|
17,305,638 |
|
|
|
14,831,787 |
|
Accumulated deficit |
|
|
(14,434,229 |
) |
|
|
(11,034,100 |
) |
Accumulated other comprehensive loss |
|
|
(393,737 |
) |
|
|
(460,015 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
2,561,784 |
|
|
|
3,407,050 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
6,598,922 |
|
|
$ |
6,401,244 |
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 3
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net sales |
|
$ |
1,760,771 |
|
|
$ |
1,554,955 |
|
|
$ |
3,524,980 |
|
|
$ |
3,200,608 |
|
Cost of goods sold |
|
|
452,857 |
|
|
|
462,317 |
|
|
|
1,008,372 |
|
|
|
883,145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
1,307,914 |
|
|
|
1,092,638 |
|
|
|
2,516,608 |
|
|
|
2,317,463 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
827,290 |
|
|
|
744,867 |
|
|
|
1,711,399 |
|
|
|
1,435,431 |
|
Research and development |
|
|
658,409 |
|
|
|
1,030,808 |
|
|
|
1,333,363 |
|
|
|
1,661,406 |
|
Selling and marketing |
|
|
1,303,696 |
|
|
|
804,606 |
|
|
|
2,536,283 |
|
|
|
1,468,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,789,395 |
|
|
|
2,580,281 |
|
|
|
5,581,045 |
|
|
|
4,565,476 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(1,481,481 |
) |
|
|
(1,487,643 |
) |
|
|
(3,064,437 |
) |
|
|
(2,248,013 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
18,308 |
|
|
|
27,616 |
|
|
|
37,815 |
|
|
|
54,996 |
|
Interest expense |
|
|
(10,483 |
) |
|
|
(4,515 |
) |
|
|
(16,465 |
) |
|
|
(9,324 |
) |
Warrant benefit (expense) |
|
|
(700,412 |
) |
|
|
701,718 |
|
|
|
(372,680 |
) |
|
|
15,423 |
|
Foreign currency exchange gain
(loss) |
|
|
3,553 |
|
|
|
(7,206 |
) |
|
|
29,964 |
|
|
|
(8,405 |
) |
Other |
|
|
(1,216 |
) |
|
|
|
|
|
|
3,585 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(690,250 |
) |
|
|
717,613 |
|
|
|
(317,781 |
) |
|
|
52,690 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(2,171,731 |
) |
|
|
(770,030 |
) |
|
|
(3,382,218 |
) |
|
|
(2,195,323 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense (benefit) |
|
|
(12,841 |
) |
|
|
(34,314 |
) |
|
|
17,911 |
|
|
|
2,706 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,158,890 |
) |
|
$ |
(735,716 |
) |
|
$ |
(3,400,129 |
) |
|
$ |
(2,198,029 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share |
|
$ |
(0.28 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.33 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
7,784,118 |
|
|
|
6,853,783 |
|
|
|
7,376,900 |
|
|
|
6,603,887 |
|
See accompanying notes to the condensed consolidated financial statements.
Page 4
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS EQUITY AND COMPREHENSIVE LOSS
Six months ended September 30, 2006
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Shareholders |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Loss |
|
|
Equity |
|
Balance at March 31, 2006 |
|
|
6,937,786 |
|
|
$ |
69,378 |
|
|
$ |
14,831,787 |
|
|
$ |
(11,034,100 |
) |
|
$ |
(460,015 |
) |
|
$ |
3,407,050 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from private
placement, net of costs
of $260,832 |
|
|
1,389,999 |
|
|
|
13,900 |
|
|
|
1,810,317 |
|
|
|
|
|
|
|
|
|
|
|
1,824,217 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant registration costs |
|
|
|
|
|
|
|
|
|
|
(4,351 |
) |
|
|
|
|
|
|
|
|
|
|
(4,351 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of Stock Options |
|
|
65,649 |
|
|
|
656 |
|
|
|
146,501 |
|
|
|
|
|
|
|
|
|
|
|
147,157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee Retirement
Savings Plan Contribution |
|
|
17,754 |
|
|
|
178 |
|
|
|
44,207 |
|
|
|
|
|
|
|
|
|
|
|
44,385 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation |
|
|
|
|
|
|
|
|
|
|
477,177 |
|
|
|
|
|
|
|
|
|
|
|
477,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,400,129 |
) |
|
|
66,278 |
|
|
|
(3,333,851 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30,
2006 |
|
|
8,411,188 |
|
|
$ |
84,112 |
|
|
$ |
17,305,638 |
|
|
$ |
(14,434,229 |
) |
|
|
($393,737 |
) |
|
$ |
2,561,784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 5
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Six Months Ended September 30, 2006 and 2005
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,400,129 |
) |
|
$ |
(2,198,029 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
147,989 |
|
|
|
116,565 |
|
Gain on disposal of furniture |
|
|
(3,584 |
) |
|
|
|
|
Warrant expense (benefit) |
|
|
372,680 |
|
|
|
(15,423 |
) |
Stock-based consulting expense |
|
|
29,524 |
|
|
|
|
|
Stock-based compensation expense |
|
|
447,652 |
|
|
|
|
|
Deferred income taxes |
|
|
(42,976 |
) |
|
|
(48,160 |
) |
Deferred rent |
|
|
(14,583 |
) |
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(368,428 |
) |
|
|
47,762 |
|
Inventories |
|
|
(221,587 |
) |
|
|
(195,071 |
) |
Other current assets and income tax receivable |
|
|
121,808 |
|
|
|
(58,945 |
) |
Accounts payable |
|
|
216,037 |
|
|
|
212,759 |
|
Deferred rent |
|
|
280,666 |
|
|
|
|
|
Accrued liabilities |
|
|
(86,062 |
) |
|
|
271,288 |
|
Accrued pension liability |
|
|
142,780 |
|
|
|
39,226 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(2,378,213 |
) |
|
|
(1,828,028 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Proceeds from sale of short-term investments |
|
|
1,137,647 |
|
|
|
|
|
Payments for property, plant and equipment |
|
|
(406,740 |
) |
|
|
(170,602 |
) |
Proceeds from sale of property, plant and equipment |
|
|
4,294 |
|
|
|
|
|
Payments for intangible assets |
|
|
|
|
|
|
(329,167 |
) |
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
735,201 |
|
|
|
(499,769 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from financing obligations |
|
|
210,999 |
|
|
|
|
|
Repayment of long-term obligations |
|
|
(104,656 |
) |
|
|
(21,650 |
) |
Proceeds from issuance of common stock and warrants |
|
|
1,967,023 |
|
|
|
6,768,191 |
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
2,073,366 |
|
|
|
6,746,541 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
(10,484 |
) |
|
|
(88,451 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
419,870 |
|
|
|
4,330,293 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
1,563,433 |
|
|
|
1,492,684 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
1,983,303 |
|
|
$ |
5,822,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
14,615 |
|
|
$ |
9,803 |
|
Cash paid during the period for income taxes |
|
|
58,335 |
|
|
|
37,598 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash financing and investing activities: |
|
|
|
|
|
|
|
|
Shares issued for 401(k) plan profit sharing contribution |
|
$ |
44,385 |
|
|
$ |
|
|
Property, plant and equipment additions funded by lessor allowance and
classified as deferred rent |
|
|
280,000 |
|
|
|
|
|
See accompanying notes to the condensed interim consolidated financial statements.
Page 6
UROPLASTY, INC. AND SUBSIDIARIES
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. Basis of Presentation
We have prepared our condensed consolidated financial statements included in this Form 10-QSB,
without audit, pursuant to the rules and regulations of the Securities and Exchange Commission.
Certain information and footnote disclosures normally included in the consolidated financial
statements prepared in accordance with accounting principles generally accepted in the United
States of America have been condensed or omitted, pursuant to such rules and regulations. The
consolidated results of operations for any interim period are not necessarily indicative of results
for a full year. These condensed consolidated financial statements should be read in conjunction
with the consolidated financial statements and related notes included in our Annual Report on Form
10-KSB for the year ended March 31, 2006.
The condensed consolidated financial statements presented herein as of September 30, 2006 and for
the three and six-month periods ended September 30, 2006 and 2005 reflect, in the opinion of
management, all material adjustments consisting only of normal recurring adjustments necessary for
a fair presentation of the consolidated financial position, results of operations and cash flows
for the interim periods.
We have identified certain accounting policies that we consider particularly important for the
portrayal of our results of operations and financial position and which may require the application
of a higher level of judgment by our management, and as a result are subject to an inherent level
of uncertainty. These are characterized as critical accounting policies and address revenue
recognition, accounts receivable, inventories, foreign currency translation and transactions,
impairment of long-lived assets, share-based compensation and income taxes, each of which is more
fully described in our Annual Report on Form 10-KSB for the year ended March 31, 2006. Based upon
our review, we have determined that these policies remain our most critical accounting policies for
the three and six-month periods ended September 30, 2006, and we have made no changes to these
policies during fiscal 2007.
2. Nature of Business, Sales of Common Stock and Corporate Liquidity
The majority of our revenue is from products sold outside of the United States. The U.S. Food and
Drug Administration (FDA) granted 510(k) premarket clearance in August 2005 for our
I-StopTM Mid-Urethral Sling, a biocompatible, tension-free sling used to treat female
urinary incontinence. In October 2005 and July 2006, we received the 510(k) premarket clearances
for, respectively, the original and enhanced versions of our Urgent® PC Neurostimulation System, a
proprietary, minimally invasive nerve stimulation device designed for office-based treatment of
overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency. In
October 2006 we received from the FDA pre-market approval for Macroplastique®, a minimally
invasive, implantable soft tissue bulking agent for the treatment of urinary incontinence. We
expect to begin marketing this product in the United States in early 2007. We have established a
sales force in the United States to commercialize these products and anticipate increasing our
sales and marketing organization.
Our future liquidity and capital requirements will depend on numerous factors including: the
timing and cost associated with FDA-required post approval studies to obtain market feedback on
safety and effectiveness on Macroplastique; the timing and cost involved in manufacturing scale-up
and in expanding our sales, marketing and distribution capabilities in the United States markets;
the cost and effectiveness of our marketing and sales efforts with respect to our existing products
in international markets; the effect of competing technologies and market and regulatory
developments; and the cost involved in protecting our proprietary rights. Because we
have yet to achieve profitability and generate positive cash flows, we need to raise additional
debt or equity financing in fiscal 2007 to continue funding for product
development and continued expansion of our sales and marketing activities. There can be no
guarantee that we will be successful, as we currently have no committed sources of, or other
arrangements with respect to, additional equity or debt financing. We
therefore cannot ensure that we will obtain additional financing on acceptable
terms, or at all. Aside from the recently established credit lines indicated below and proceeds
from our August 2006 private placement, we have no committed resources of, or other arrangements
with respect to, additional financing. If we are unable to raise substantial funds in fiscal 2007,
we will need to rely on our existing credit facilities and curtail our operations including product
development, clinical studies and sales and marketing activities in order to conserve cash and
maintain our operations through the balance of fiscal 2007. This would adversely impact our future
business and prospects. In any event, because we are not profitable, we will need to raise
substantial additional financing to support our operations and planned growth activities in fiscal
2008 and beyond.
Ultimately, we will need to achieve profitability and generate positive cash flows from operations
to fund our operations and grow our business.
Page 7
In October 2006, we amended our business loan agreement with Venture Bank. The amended agreement
provides for a credit line of up to $500,000 secured by substantially all of our assets. We may
borrow up to 50% of the value of the inventory on hand in the U.S. and 75% of the U.S. accounts
receivable value. The bank charges us interest on the loan at the rate of 1 percentage point over
the prime rate (8.25% at September 30, 2006) subject to a minimum interest rate of 7% per annum.
In June 2006, we entered into a $100,000 3-year, term loan agreement with Venture Bank, at an
interest rate of 8.25% per annum. In addition, Uroplasty BV, one of our subsidiaries entered into
an arrangement with Rabobank of The Netherlands for a 200,000 (approximately $258,500) credit
line.
At September 30, 2006, we had no borrowings against any of our credit lines.
3. Short-term Investments
At March 31, 2006, short-term investments consisted of certificates of deposit that matured in the
first quarter of fiscal 2007.
4. Inventories
Inventories are stated at the lower of cost (first-in, first-out method) or market (net realizable
value) and consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2006 |
|
|
March 31, 2006 |
|
Raw materials |
|
$ |
368,435 |
|
|
$ |
340,268 |
|
Work-in-process |
|
|
46,806 |
|
|
|
26,183 |
|
Finished goods |
|
|
610,804 |
|
|
|
390,611 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,026,045 |
|
|
$ |
757,062 |
|
|
|
|
|
|
|
|
5. Intangible Assets
Intangible assets are comprised of patents, trademarks and licensed technology which are amortized
on a straight-line basis over their estimated useful lives or contractual terms, whichever is less.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2006 |
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
|
|
Estimated |
|
Carrying |
|
|
Accumulated |
|
|
|
|
|
|
Lives (Years) |
|
Amount |
|
|
Amortization |
|
|
Net value |
|
Licensed technology |
|
5 |
|
$ |
501,290 |
|
|
$ |
160,874 |
|
|
$ |
340,416 |
|
Patents and inventions |
|
6 |
|
|
237,900 |
|
|
|
219,825 |
|
|
|
18,075 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
|
|
$ |
739,190 |
|
|
$ |
380,699 |
|
|
$ |
358,491 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2006 |
|
Licensed technology |
|
5 |
|
$ |
501,290 |
|
|
$ |
111,183 |
|
|
$ |
390,107 |
|
Patents and inventions |
|
6 |
|
|
237,900 |
|
|
|
216,403 |
|
|
|
21,497 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
|
|
$ |
739,190 |
|
|
$ |
327,586 |
|
|
$ |
411,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Page 8
Estimated annual amortization for these assets for the fiscal years ended March 31 is as follows:
|
|
|
|
|
Remainder of fiscal 2007 |
|
$ |
50,399 |
|
2008 |
|
|
100,756 |
|
2009 |
|
|
100,652 |
|
2010 |
|
|
98,369 |
|
2011 |
|
|
8,315 |
|
|
|
|
|
|
|
$ |
358,491 |
|
|
|
|
|
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, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net loss |
|
$ |
(2,158,890 |
) |
|
$ |
(735,716 |
) |
|
$ |
(3,400,129 |
) |
|
$ |
(2,198,029 |
) |
Items of other comprehensive
income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
(18,492 |
) |
|
|
(6,713 |
) |
|
|
78,097 |
|
|
|
(214,872 |
) |
Additional pension liability |
|
|
(416 |
) |
|
|
203 |
|
|
|
(11,819 |
) |
|
|
4,612 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(2,177,798 |
) |
|
$ |
(742,226 |
) |
|
$ |
(3,333,851 |
) |
|
$ |
(2,408,289 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
7. Basic and Diluted Net Loss per Common Share.
We have excluded the following options and warrants outstanding at September 30, 2006 and 2005 to
purchase shares of common stock from diluted loss per common share as they have an anti-dilutive
effect because the Company had a loss in each of those periods:
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
Range of Exercise |
|
|
Options/Warrants |
|
Prices |
For the three and six months ended
September 30: |
|
|
|
|
|
|
|
|
2006 |
|
|
4,967,380 |
|
|
$ 0.90 to $5.30 |
2005 |
|
|
3,597,705 |
|
|
$0.90 to $10.50 |
8. Shareholders Equity
Warrants
As a result of the suspension of the exercise of the 706,218 warrants we originally issued in July
2002, we granted a like number of new common stock purchase warrants to the holders of the expired
warrants in April 2005. The new warrants are exercisable at $2.00 per share for 90 days after the
effective date of a registration statement covering the shares underlying these warrants. Although
as of September 30, 2006, we had filed this registration statement, the U.S. Securities and
Exchange Commission had not declared it effective. We anticipate seeking effectiveness of the
registration statement before the end of calendar year 2006. In April 2005, we recognized a
liability and a charge to equity of approximately $1.4 million associated with the grant of these
new warrants. We determined the fair value of these warrants using the Black-Scholes
option-pricing model. We have since reduced the reported liability to approximately $1.0 million
due to the decrease in the fair value of these warrants from their date of issuance through
September 30, 2006. We recorded a warrant (expense) benefit of $(700,000) and $702,000 for the
three months ended September 30, 2006 and 2005, respectively,
and $(373,000) and $15,000 for the six months ended September 30,
2006 and 2005, respectively. We will continue to remeasure the value
of this liability in relation to its fair value and adjust
accordingly until such time as the warrants are exercised or expire.
Page 9
In connection with our April 2005 private placement, we issued 1,180,928 warrants to purchase
shares of common stock and registered the public resale the underlying shares for the security
holders. The warrants are exercisable for five years at an exercise price of $4.75.
As part of a consulting agreement with CCRI Corporation, we issued a warrant to purchase 50,000
shares of common stock at a price of $3.00 per share on April 1, 2003, and an additional warrant to
purchase 50,000 shares at a price of $5.00 on November 2, 2003. At September 30, 2006, all of
these warrants were outstanding and expire five years from the date of issue.
In connection with our August 2006 private placement, we issued 695,000 warrants to purchase shares
of our common stock. We also sold to the placement agent a warrant to purchase 69,500 shares of
our common stock. We registered the public resale of the underlying shares for the security
holders. The warrants are exercisable for five years, beginning on February 4, 2007, at an
exercise price of $2.50 per share.
Authorized Common Shares
At our annual shareholders meeting in October 2006, our shareholders approved the proposal to amend
our Restated Articles of Incorporation to increase the number of authorized common shares from
20,000,000 to 40,000,000.
9. Share-based Compensation
As of September 30, 2006, we had one active plan (2006 Stock and Incentive Plan) for share-based
compensation awards. Under the plan, if we have a change in control, all outstanding awards,
including those subject to vesting or other performance targets, fully vest immediately. We have
reserved 1,200,000 shares of our common stock for stock-based awards under this plan, and as of
September 30, 2006, we had granted awards for 173,000 options. We generally grant option awards
with an exercise price equal to the market price of our stock at the date of the grant.
On April 1, 2006, we adopted Statement of Financial Accounting Standards No. 123(R), Share-Based
PaymentRevised 2004 (SFAS No. 123(R)), using the modified prospective transition method. Prior
to the adoption of SFAS No. 123(R), we accounted for stock option grants in accordance with APB
Opinion No. 25, Accounting for Stock Issued to Employees (the intrinsic value method), and
accordingly, recognized no compensation expense for stock option grants.
Under the modified prospective method, we recognize share-based employee compensation cost using
the fair-value based method for all new awards granted after April 1, 2006 and to awards
outstanding on April 1, 2006 that we subsequently modify, repurchase or cancel. We recognize
compensation costs for unvested stock options and awards that are outstanding as of the April 1,
2006 adoption date, over the remaining requisite service period based on the grant-date fair value
of those options and awards as previously calculated under the pro-forma disclosures pursuant to
Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation
(SFAS No. 123). We were not required to restate prior periods to reflect the impact of adopting
the new standard. We incurred a total of $148,000 and $448,000 in compensation expense for the
three and six months ended September 30, 2006, respectively, as a result of our adoption of SFAS
No. 123(R).
As a result of adopting SFAS No. 123(R), for the three and six months ended September 30, 2006, our
loss before taxes, net loss, and basic and diluted loss per share were higher than if we had
continued to account for stock-based compensation under APB Opinion No. 25 for our stock option
grants (see chart below).
Page 10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, 2006 |
|
|
September 30, 2006 |
|
|
|
|
|
|
|
Proforma |
|
|
|
|
|
|
Proforma |
|
|
|
|
|
|
|
Under |
|
|
|
|
|
|
Under |
|
|
|
As Reported |
|
|
APB 25 |
|
|
As Reported |
|
|
APB 25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes |
|
$ |
(2,171,731 |
) |
|
$ |
(2,171,731 |
) |
|
$ |
(3,382,218 |
) |
|
$ |
(3,382,218 |
) |
Add back compensation expense |
|
|
|
|
|
|
148,056 |
|
|
|
|
|
|
|
447,652 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted loss before taxes |
|
|
(2,171,731 |
) |
|
|
(2,023,675 |
) |
|
|
(3,382,218 |
) |
|
|
(2,934,566 |
) |
Income tax expense (benefit) |
|
|
(12,841 |
) |
|
|
(12,841 |
) |
|
|
17,911 |
|
|
|
17,911 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,158,890 |
) |
|
$ |
(2,010,834 |
) |
|
$ |
(3,400,129 |
) |
|
$ |
(2,952,477 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share
basic and diluted |
|
$ |
(0.28 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.40 |
) |
Proceeds from the exercise of stock options were $134,359 and $147,158 for the three and six months
ended September 30, 2006.
The following table illustrates the effect on operating results and per share information had we
accounted for stock-based compensation in accordance with SFAS No. 123(R) for the three and six
months ended September 30, 2005, and reported compensation expense of $425,000 and $858,000,
respectively. We intend to show similar pro forma information in our future fiscal 2007 reports
because we believe this presentation facilitates a quarter-to-quarter understanding of the effect
of SFAS No. 123(R) on our fiscal 2007 results.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net loss As reported |
|
$ |
(2,158,890 |
) |
|
$ |
(735,716 |
) |
|
$ |
(3,400,129 |
) |
|
$ |
(2,198,029 |
) |
Deduct: Pro forma
stock-based employee
compensation expense
determined under fair
value-based method |
|
|
|
|
|
|
(424,902 |
) |
|
|
|
|
|
|
(858,333 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
Pro forma |
|
$ |
(2,158,890 |
) |
|
$ |
(1,160,618 |
) |
|
$ |
(3,400,129 |
) |
|
$ |
(3,056,362 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share As reported: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.28 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.33 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share Pro forma: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.28 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.46 |
) |
Page 11
We determined the fair value of our option awards using the Black-Scholes option pricing model. We
used the following weighted-average assumptions to value the options granted during the three and
six-months ended September 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, 2006 |
|
|
September 30, 2006 |
|
Expected life in years |
|
|
5.00 |
|
|
|
7.88 |
|
Risk-free interest rate |
|
|
4.77 |
% |
|
|
4.98 |
% |
Expected volatility |
|
|
100.26 |
% |
|
|
100.26 |
% |
Expected dividend yield |
|
|
0 |
|
|
|
0 |
|
Weighted-average fair value |
|
|
1.396 |
|
|
|
1.964 |
|
The expected life selected for options granted during the quarter represents the period of time
that we expect our options to be outstanding based on historical data of option holder exercise and
termination behavior for similar grants. The risk-free interest rate for periods within the
contractual life of the option is based on the U.S. Treasury rate over the expected life at the
time of grant. Expected volatilities are based upon historical volatility of our stock.
As of September 30, 2006, we had approximately $635,244 of unrecognized compensation cost related
to share-based payments that we expect to recognize over a weighted-average period of 1.68 years.
The following table summarizes activity related to our stock options during the six months ended
September 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Avg |
|
|
|
|
|
|
|
Weighted Avg |
|
|
Remaining |
|
|
|
Number of Shares |
|
|
Exercise Price |
|
|
Contract Life |
|
|
|
|
Options outstanding at beginning of
period |
|
|
1,888,327 |
|
|
$ |
3.80 |
|
|
|
4.48 |
|
Options granted |
|
|
493,000 |
|
|
|
2.32 |
|
|
|
7.60 |
|
Options exercised |
|
|
(65,649 |
) |
|
|
2.24 |
|
|
|
|
|
Options surrendered |
|
|
(99,944 |
) |
|
|
2.89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at end of period |
|
|
2,215,734 |
|
|
$ |
3.56 |
|
|
|
4.97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at end of period |
|
|
1,811,416 |
|
|
$ |
3.82 |
|
|
|
4.57 |
|
10. Savings and Retirement Plans
We sponsor various plans for eligible employees in the United States, the United Kingdom (UK), and
The Netherlands. Our retirement savings plan in the United States conforms to Section 401(k) of
the Internal Revenue Code and participation is available to substantially all employees. We may
also make discretionary contributions ratably to all eligible employees. We made no discretionary
contributions in association with these plans in the United States for the three and six-month
periods ended September 30, 2006 and 2005, respectively.
Our international subsidiaries have defined benefit retirement plans for eligible employees. These
plans provide benefits based on each employees years of service and compensation during the years
immediately preceding retirement, termination, disability, or death, as defined in the plans. We
invest pension plan assets in insurance contracts. We closed the defined benefit plan in The
Netherlands for new employees effective April 2005. At that time, our Dutch subsidiary established
a defined contribution plan. We froze our UK subsidiarys defined benefit plan on December 31,
2004. On March 10, 2005, our UK subsidiary established a defined contribution plan.
Page 12
The cost for our defined benefit retirement plans in The Netherlands and the United Kingdom
includes the following components for the three and six-month periods ended September 30, 2006 and
2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Gross service cost |
|
$ |
51,303 |
|
|
$ |
43,436 |
|
|
$ |
101,845 |
|
|
$ |
88,297 |
|
Interest cost |
|
|
30,941 |
|
|
|
24,975 |
|
|
|
61,354 |
|
|
|
50,810 |
|
Expected return on assets |
|
|
(17,764 |
) |
|
|
(14,403 |
) |
|
|
(35,208 |
) |
|
|
(29,314 |
) |
Amortization |
|
|
10,604 |
|
|
|
7,037 |
|
|
|
21,035 |
|
|
|
14,303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic retirement cost |
|
$ |
75,084 |
|
|
$ |
61,045 |
|
|
$ |
149,026 |
|
|
$ |
124,096 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Major assumptions used in the above calculations include:
|
|
|
|
|
|
|
|
|
|
|
Three and Six Months |
|
|
|
Ended |
|
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
Discount rate |
|
|
4.255.50 |
% |
|
|
4.505.25 |
% |
Expected return on assets |
|
|
4.005.00 |
% |
|
|
4.005.00 |
% |
Expected rate of increase in future compensation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General |
|
|
3 |
% |
|
|
3 |
% |
Individual |
|
|
0%3 |
% |
|
|
0%3 |
% |
11. Foreign Currency Translation
We translate all assets and liabilities using period-end exchange rates. We translate statements
of operations items using average exchange rates for the period. We record the resulting
translation adjustment within accumulated other comprehensive loss, a separate component of
shareholders equity. We recognize foreign currency transaction gains and losses in our
consolidated statements of operations, including unrealized gains and losses on short-term
intercompany obligations using period-end exchange rates. We recognize unrealized gains and losses
on long-term intercompany obligations within accumulated other comprehensive loss, a separate
component of shareholders equity.
We recognize exchange gains and losses primarily as a result of fluctuations in currency rates
between the U.S. dollar (the functional reporting currency) and the euro and British pound
(currencies of our subsidiaries), as well as their effect on the dollar denominated intercompany
obligations between us and our foreign subsidiaries. All intercompany balances are revolving in
nature and we do not deem them to be long-term balances. For the three months ended September 30,
2006 and 2005, we recognized foreign currency gain (loss) of $3,553 and $(7,206), respectively.
For the six months ended September 30, 2006 and 2005, we recognized foreign currency gain (loss) of
$29,964 and $(8,405), respectively.
12. Income Tax Expense
During the three months ended September 30, 2006 and 2005, our Dutch subsidiaries recorded income
tax benefit of $12,841 and $34,314, respectively. During the six months ended September 30, 2006
and 2005, our Dutch subsidiaries recorded income tax expense of $17,911 and $2,706, respectively.
We cannot use our U.S. net operating loss carry forwards to offset taxable income in foreign
jurisdictions.
Page 13
13. Business Segment and Geographic Information
We sell proprietary products for the treatment of voiding dysfunctions. Our current primary
product is Macroplastique®, a soft tissue bulking material used for the treatment of urinary
incontinence and vesicoureteral reflux. In addition, we market soft tissue bulking material for
additional indications, including the treatment of vocal cord rehabilitation, fecal incontinence
and soft tissue dermal augmentation. At this time, all sales for the tissue bulking agent products
are outside the United States. The Macroplastique product line accounted for 56% and 70%, respectively, of total net sales for the
six months ended September 30, 2006 and 2005, respectively.
The U.S. Food and Drug Administration (FDA) granted 510(k) premarket clearance for the I-Stop
polypropylene, tension-free, mid-urethral sling for the treatment of female urinary incontinence in
August 2005. We have exclusive distribution rights for this product in the United States and the
United Kingdom. In October 2005 and July 2006, we received U.S. FDA 510(k) premarket clearance
for, respectively, the original and enhanced versions of our Urgent® PC Neuromodulation System, a
minimally invasive nerve stimulation device designed for office-based treatment of overactive
bladder symptoms of urge incontinence, urinary urgency and urinary frequency. We started selling
the Urgent PC device in November 2005 in the United States and in December 2005 in Europe and
Canada. The Urgent PC is also indicated for the treatment of fecal incontinence outside the United
States. In October 2006 we received from the FDA pre-market approval for Macroplastique. We
expect to begin marketing this product in the United States in early 2007. In addition, we are a
distributor of specialized wound care products in The Netherlands and United Kingdom.
Based upon the above, we operate in only one reportable segment consisting of medical products
primarily for the urology market.
Information regarding operations in different geographies for the three and six months ended
September 30, 2006 and 2005 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments |
|
|
|
|
|
|
United |
|
|
The |
|
|
United |
|
|
and |
|
|
|
|
|
|
States |
|
|
Netherlands |
|
|
Kingdom |
|
|
Eliminations |
|
|
Consolidated |
|
Fiscal 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, three months
ended September 30,
2006 |
|
$ |
707,733 |
|
|
$ |
1,252,452 |
|
|
$ |
423,270 |
|
|
$ |
(622,684 |
) |
|
$ |
1,760,771 |
|
Sales, six months
ended September 30,
2006 |
|
|
1,006,033 |
|
|
|
2,415,581 |
|
|
|
952,707 |
|
|
|
(849,341 |
) |
|
|
3,524,980 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit,
three months ended
September 30, 2006 |
|
|
|
|
|
|
(12,841 |
) |
|
|
|
|
|
|
|
|
|
|
(12,841 |
) |
Income tax expense,
six months ended
September 30, 2006 |
|
|
|
|
|
|
17,911 |
|
|
|
|
|
|
|
|
|
|
|
17,911 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss),
three months ended
September 30, 2006 |
|
|
(2,007,429 |
) |
|
|
1,283 |
|
|
|
(41,669 |
) |
|
|
(111,075 |
) |
|
|
(2,158,890 |
) |
Net income (loss),
six months ended
September 30, 2006 |
|
|
(3,355,374 |
) |
|
|
109,210 |
|
|
|
(99,344 |
) |
|
|
(54,621 |
) |
|
|
(3,400,129 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets
At September 30, 2006 |
|
|
1,047,566 |
|
|
|
730,261 |
|
|
|
5,766 |
|
|
|
|
|
|
|
1,783,593 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, three months
ended September 30,
2005 |
|
$ |
194,076 |
|
|
$ |
1,238,605 |
|
|
$ |
460,758 |
|
|
$ |
(338,484 |
) |
|
$ |
1,554,955 |
|
Sales, six months
ended September 30,
2005 |
|
|
334,897 |
|
|
|
2,576,206 |
|
|
|
918,528 |
|
|
|
(629,023 |
) |
|
|
3,200,608 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit,
three months ended
September 30, 2005 |
|
|
|
|
|
|
(34,314 |
) |
|
|
|
|
|
|
|
|
|
|
(34,314 |
) |
Income tax expense,
six months ended
September 30, 2005 |
|
|
|
|
|
|
2,706 |
|
|
|
|
|
|
|
|
|
|
|
2,706 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss),
three months ended
September 30, 2005 |
|
|
(641,312 |
) |
|
|
(122,681 |
) |
|
|
(12,678 |
) |
|
|
40,955 |
|
|
|
(735,716 |
) |
Net income (loss),
six months ended
September 30, 2005 |
|
|
(2,297,787 |
) |
|
|
(134,784 |
) |
|
|
31,736 |
|
|
|
202,806 |
|
|
|
(2,198,029 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets
At September 30, 2005 |
|
|
668,167 |
|
|
|
733,711 |
|
|
|
4,884 |
|
|
|
|
|
|
|
1,406,762 |
|
Page 14
14. Recently Issued Accounting Standards
In July 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxesan
Interpretation of FASB Statement 109, or FIN 48, which clarifies the accounting for uncertainty in
tax positions. FIN 48 requires that we recognize the tax effects from an uncertain tax position
in our financial statements only if the position is more likely than not of being sustained on
audit, based on the technical merits of the position. The provisions of FIN 48 are effective as of
the beginning of our fiscal 2008, with the cumulative effect of the change in accounting principle
recorded as an adjustment to opening retained earnings. We are currently evaluating the impact, if
any, of adopting FIN 48 on our financial statements.
In September 2006, the FASB issued Statement 157, Fair Value Measurements, or SFAS 157, which
defines fair value and establishes a framework for measuring fair value in generally accepted
accounting principles. SFAS 157 sets forth a standard definition of fair value as it applies to
assets or liabilities, the principal market (or most advantageous market) for determining fair
value (price), the market participants, inputs and the application of the derived fair value to
those assets and liabilities. The effective date of this pronouncement is for all full fiscal and
interim periods beginning after November 15, 2007. We are currently evaluating the impact, if any,
of adopting FASB Statement 157 on our financial statements.
In September 2006, FASB issued Statement 158, Employers Accounting for Defined Benefit Pension and
Other Postretirement Plans, or SFAS 158, which requires employers to recognize the overfunded or
underfunded status of a defined benefit postretirement plan as an asset or liability in its
financial statements and to recognize changes in that funded status in the year in which the
changes occur. The Statement is effective for us as of March 31, 2007. We are currently
evaluating the impact, if any, of adopting SFASB 158 on our financial statements.
In September 2006, the SEC staff issued Staff Accounting Bulletin (SAB) No. 108, Considering the
Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial
Statements (SAB 108). SAB 108 was issued in order to eliminate the diversity of practice in how
public companies quantify misstatements of financial statements, including misstatements that were
not material to prior years financial statements. We will initially apply the provisions of SAB
108 in connection with the preparation of our annual financial statements for the fiscal year
ending March 31, 2007. We do not believe the adoption of SAB 108 will have a material impact on
our financial statements.
15. Subsequent Event
In October 2006, we retained Craig-Hallum Capital Group LLC to act as our selling agent in
connection with a public offering of up to $12 million of our common stock. The selling agent is
not required to sell any specific number or dollar amount of securities in this offering, but will
use its best efforts to sell the securities offered.
Page 15
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We recommend that you read this Report on Form 10-QSB in conjunction with our Annual Report on Form
10-KSB for the year ended March 31, 2006.
Forward-looking Statements
We may from time to time make written or oral forward-looking statements, including our
statements contained in this filing with the Securities and Exchange Commission and in our reports
to stockholders, as well as elsewhere. Forward-looking statements are statements such as those
contained in projections, plans, objectives, estimates, statements of future economic performance,
and assumptions related to any of the foregoing, and may be identified by the use of
forward-looking terminology, such as may, expect, anticipate, estimate, goal, continue,
or other comparable terminology. By their very nature, forward-looking statements are subject to
known and unknown risks and uncertainties relating to our future performance that may cause our
actual results, performance, or achievements, or industry results, to differ materially from those
expressed or implied in any such forward-looking statements. Any such statement is qualified by
reference to the following cautionary statements.
Our business operates in highly competitive markets and is subject to changes in general economic
conditions, competition, customer and market preferences, government regulation, the impact of tax
regulation, foreign exchange rate fluctuations, the degree of market acceptance of products, the
uncertainties of potential litigation, as well as other risks and uncertainties detailed elsewhere
herein and from time to time in our Securities and Exchange Commission filings.
In this filing, the section entitled Managements Discussion and Analysis of Financial Condition
and Results of Operations contains forward-looking statements. Various factors and risks (not all
of which are identifiable at this time) could cause our results, performance, or achievements to
differ materially from that contained in our forward-looking statements, and investors are
cautioned that any forward-looking statement contained herein or elsewhere is qualified by and
subject to the warnings and cautionary statements contained above and in our other filings with the
Securities and Exchange Commission.
We do not undertake, nor assume obligation, to update any forward-looking statement that we may
make from time to time.
Overview
We are a medical device company that develops, manufactures and markets innovative,
proprietary products for the treatment of voiding dysfunctions. Our minimally invasive products
treat urinary incontinence and overactive bladder symptoms. We believe that our company is uniquely
positioned because we offer a broad and diverse set of products to address the various preferences
of doctors and patients, as well as the quality of life issues presented by voiding dysfunctions.
We currently offer three medical devices for the treatment of incontinence and overactive bladder
symptoms.
Strategy
Our goal is to gain market share in the voiding dysfunction market by expanding our portfolio of
minimally invasive products for the treatment of voiding dysfunctions, with a particular focus on
products and applications for outpatient and office-based procedures. We believe that, with a
suite of innovative products, we can increasingly garner the attention of key physicians, our
independent sales representatives and distributors to enhance market acceptance of our products.
The key elements of our strategy are to:
|
|
|
Focus on office-based solutions for physicians. We believe that our company is uniquely
positioned to provide a broad product offering of office-based solutions for physicians.
By expanding our U.S. presence, we intend to develop long-standing relationships with
leading physicians treating incontinence and overactive bladder symptoms. These
relationships will provide us with a source of new product ideas and a conduit through
which to introduce new products. We have also intend to develop marketing programs to
assist physicians in marketing their practices and to provide innovative programs focused
on helping physicians attract patients and develop referral networks. Building these
relationships is an important part of our growth strategy, particularly for the development
and introduction of new products. |
|
|
|
|
Grow our U.S. sales and international distribution. We believe that in addition to
international market, the U.S. is a significant opportunity for future sales of our
products. In order to grow our U.S. business, we recently created our sales organization,
consisting of a direct field sales management team and independent sales representatives,
and a
marketing organization to market our products directly to our customers. We anticipate
further increasing, as
needed, our sales and marketing organization in the United States to
support our sales growth. In addition, we intend to expand our European presence by
creating new distribution partnerships. |
Page 16
|
|
|
Educate physicians and patients about the benefits of Urgent PC. We believe education
of physicians and patients regarding the benefits of Urgent PC is critical to the
successful adoption of this product. To this end, we have initiated a clinical trial,
which is a U.S. multi-center randomized prospective study comparing the Urgent PC device to
the most commonly prescribed pharmaceutical treatment for OAB symptoms. We believe the
results of this and other studies, if successful, will allow us to expand our marketing and
sales efforts. These sales and marketing efforts may include physician training and
education programs which will emphasize the clinical efficacy and ease of use of our Urgent
PC product as well as patient-oriented marketing materials for physicians to use to inform
patients of the availability and potential benefits of our Urgent PC product. |
|
|
|
|
Provide patient-driven alternatives. Patients often weigh the quality of life benefits
of electing to undergo a surgical procedure against the invasiveness of the procedure. We
intend to continue to expand our marketing efforts to build patient awareness of these
treatment alternatives and encourage patients to see physicians. We believe this will help
physicians build their practices and simultaneously increase sales of our products. |
|
|
|
|
Develop, license or acquire products. We believe that our broad and diverse product
offering is an important competitive advantage because it allows us to address the various
preferences of doctors and patients, as well as the quality of life issues presented by
voiding dysfunctions. Consolidation among hospital buying groups has reduced the number of
suppliers from which hospitals purchase products, providing an advantage to suppliers
offering a broad range of products. An important part of our growth strategy is to broaden
our product line further to meet customer needs by developing new products internally,
licensing or acquiring new products through acquisitions. |
Our Products
Macroplastique is a minimally invasive, implantable soft tissue bulking agent for the
treatment of urinary incontinence. When Macroplastique is injected into tissue around the urethra,
it stabilizes and bulks tissues close to the urethra, thereby providing the surrounding muscles
with increased capability to control the release of urine. Macroplastique has been sold for
urological indications in over 40 countries outside the United States since 1991. In October 2006,
we received from the FDA pre-market approval for Macroplastique. We expect to begin marketing this
product in the United States in early 2007. However, we cannot assure that we can market
Macroplastique profitability in the U.S.
I-Stop is a minimally invasive biocompatible, polypropylene, tension-free sling for the
treatment of female urinary incontinence. Our I-Stop sling can correct stress urinary incontinence
by providing tension-free hammock-type support for the urethra to prevent its downward movement and
the associated leakage of urine. In August 2005, FDA granted 510(k) clearance for the sale of
I-Stop within the United States.
The Urgent PC neuromodulation system is a minimally invasive device designed for office-based
treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary
frequency. This product uses percutaneous tibial nerve stimulation to deliver an electrical pulse
that travels to the sacral nerve plexus, a control center for bladder function. We received
regulatory approvals for the sale of Urgent PC in the United States and Canada in October 2005, and
in Europe in November 2005. Subsequently, we launched the product for sale in those markets. We
developed a second generation Urgent PC product during 2006. Following CE mark approval and 510(k)
clearance, we launched this product for sale in Europe in September 2006 and in the United States
in October 2006.
Sales and Marketing
We are focusing our sales and marketing efforts primarily on office-based and outpatient
surgery-based urologists, urogynecologists and gynecologists with significant patient volume. We
believe the United States is a significant opportunity for future sales of our products. In order
to grow our United States business, we recently established a sales organization, consisting of a
direct field sales management team and independent sales representatives, and a marketing
organization to market our products directly to our customers. By expanding our United States
presence, we intend to develop long-standing relationships with leading physicians treating
incontinence and overactive bladder symptoms. Outside of the United States, we sell our products
primarily through a direct and independent sales organization in the United Kingdom and primarily
through distributors in other markets.
Page 17
Critical Accounting Policies
We prepare our consolidated financial statements in accordance with U.S. generally accepted
accounting principles, which require us to make estimates and assumptions in certain circumstances
that affect amounts reported. In preparing these consolidated financial statements, we have made
our best estimates and judgments of certain amounts, giving due consideration to materiality. We
believe that of our significant accounting policies, the following are particularly important to
the portrayal of our results of operations and financial position. They may require the
application of a higher level of judgment by Uroplasty management, and as a result are subject to
an inherent degree of uncertainty.
Revenue Recognition. The Securities and Exchange Commissions Staff Accounting Bulletin (SAB) No.
104, Revenue Recognition in Financial Statements, provides guidance on the application of
generally accepted accounting principles to selected revenue recognition issues. We believe our
revenue recognition policies comply with SAB 104. We market and distribute our products primarily
through our direct and independent sales organization in the United States and the United Kingdom,
and primarily through distributors in our other markets. We recognize revenue upon shipment of
product to our distributors and direct customers. We have no customer acceptance provisions or
installation obligations. Our sales terms to our distributors and customers provide no right of
return outside of our standard warranty, and payment terms consistent with industry standards
apply. Sales terms and pricing to our distributors are governed by the respective distribution
agreements. Our distribution partners purchase the Uroplasty products to meet sales demand of
their end-user customers as well as to fulfill their internal requirements associated with the
sales process and, if applicable, contractual purchase requirements under the respective
distribution agreements. Internal and other requirements include purchases of products for
training, demonstration and evaluation purposes, clinical evaluations, product support,
establishing inventories, and meeting minimum purchase commitments. As a result, the level of our
net sales during any period is not necessarily indicative of our distributors sales to end-user
customers during that period, which we estimate are not substantially different than our sales to
those distributors in each of the last two years. Our distributors level of inventories of our
products, their sales to end-user customers and their internal product requirements may impact our
future revenue growth.
Accounts Receivable. We carry our accounts receivable at the original invoice amount less an
estimate made for doubtful receivables based on a periodic review of all outstanding amounts. We
determine the allowance for doubtful accounts based on customer health, and both historical and
expected credit loss experience. We write off our accounts receivable when we deem them
uncollectible. We record recoveries of accounts receivable previously written off when received.
Inventories. We state inventories at the lower of cost or market using the first-in, first-out
method. We provide lower of cost or market reserves for slow moving and obsolete inventories based
upon current and expected future product sales and the expected impact of product transitions or
modifications. While we expect our sales to grow, a reduction in sales could reduce the demand for
our products and may require additional inventory reserves.
Foreign Currency Translation/Transactions. The financial statements of our foreign
subsidiaries were translated in accordance with the provisions of SFAS No. 52 Foreign Currency
Translation. Under this Statement, we translate all assets and liabilities using period-end
exchange rates, and we translate statements of operations items using average exchange rates for
the period. We record the resulting translation adjustment within accumulated other comprehensive
loss, a separate component of shareholders equity. We recognize foreign currency transaction
gains and losses in the statement of operations, including unrealized gains and losses on
short-term intercompany obligations using period-end exchange rates, resulting in an increase in
the volatility of our consolidated statements of operations. We recognize unrealized gains and
losses on long-term intercompany obligations within accumulated other comprehensive loss, a
separate component of shareholders equity.
Impairment of Long-Lived Assets. Long-lived assets at September 30, 2006 consist of property, plant
and equipment and intangible assets. We review our long-lived assets for impairment whenever events
or business circumstances indicate that the carrying amount of an asset may not be recoverable. We
measure the recoverability of assets to be held and used by a comparison of the carrying amount of
an asset to future undiscounted net cash flows expected to be generated by the asset. If we
consider such assets impaired, we measure the impairment to be recognized by the amount by which
the carrying amount of the assets exceeds the fair value of the assets. We report assets to be
disposed of at the lower of the carrying amount or fair value less costs to sell.
Share-Based Compensation. FASB published Statement No. 123 (revised 2004), Share-Based Payment
(SFAS 123(R) or the Statement). SFAS 123(R) requires that we recognize the compensation cost
relating to share-based payment transactions, including grants of employee stock options, in our
financial statements. We must measure that cost based on the fair value of the equity or liability
instruments issued. SFAS 123(R) covers a wide range of share-based compensation arrangements
including stock options, restricted share plans, performance-based awards, share appreciation
rights, and
employee share purchase plans. SFAS 123(R) is a replacement of Statement No. 123, Accounting for
Stock-Based Compensation, and supersedes APB 25, and its related interpretive guidance.
Page 18
This Statement requires us to measure the cost of employee services received in exchange for stock
options based on the grant-date fair value of the award, and to recognize the cost over the period
we require our employee to provide services for the award. We adopted SFAS 123(R) for the first
time in the first quarter of fiscal year 2007. We adopted the Statement beginning April 1, 2006,
under the modified prospective transition method. We calculated the pro forma compensation costs
presented previously and in our prior filings using a Black-Scholes option pricing model. These
compensation costs may not be indicative of amounts which we will incur in future years.
Income Taxes. We recognize deferred tax assets and liabilities for future tax consequences
attributable to differences between the financial carrying amounts of existing assets and
liabilities and their respective tax bases. We measure deferred tax assets and liabilities using
enacted tax rates we expect to apply to taxable income in the years in which we expect to recover
or settle those temporary differences. We have generated approximately $15,423,000 in U.S. net
operating loss carryforwards that we cannot use to offset taxable income in foreign jurisdictions.
We recognize a valuation allowance when we determine it is more likely than not that we will not
realize a portion of the deferred tax asset. We have established a valuation allowance for U.S. and
certain foreign deferred tax assets due to the uncertainty that we will generate enough income in
those taxing jurisdictions to utilize the assets.
In addition, U.S. tax rules impose limitations on the use of net operating loss following certain
changes in ownership. Such a change in ownership may limit the amount of these benefits that would
be available to offset future taxable income each year, starting with the year of ownership change.
Set forth below is managements discussion and analysis of the financial condition and results of
operations for the three and six-months ended September 30, 2006 and 2005.
Results of Operations
Three months ended September 30, 2006 compared to three months ended September 30, 2005
Net Sales: During the three months ended September 30, 2006, net sales were $1.8 million,
representing a $206,000 or a 13% increase compared to net sales of $1.6 million for the three
months ended September 30, 2005. Excluding the impact of fluctuations in foreign currency exchange
rates, sales increased by approximately 9%. A 14% decline in sales of Macroplastique products was
more than offset by sales of the Urgent PC. During the three months ended September 30, 2005, we
had no sales of the Urgent PC.
We attribute the decline in sales of the Macroplastique products primarily due to adverse changes
in the implementation of reimbursement policies by the governments in countries outside the U.S.,
and the increase in pricing competition. We expect this to adversely impact our future sales in
those markets. In response, we have implemented targeted volume price reductions, have increased
the number of training workshops targeted to our distributors and key incontinence surgeons, and
are sponsoring scientific podium presentations and seminars at the most highly recognized
international incontinence congresses. We cannot assure that these initiatives will increase
Macroplastique sales.
Gross Profit: Gross profit was $1.3 million and $1.1 million for the three months ended September
30, 2006 and 2005, respectively, or 74% and 70% of net sales in the respective periods. We
attribute the increase in gross profit percent primarily to increased manufacturing capacity
utilization, as we stepped up production to build inventory to meet our needs during the transition
period when we relocate our manufacturing operations to our new corporate headquarters in
Minnetonka, MN. We expect to relocate the manufacturing operations in our third fiscal quarter and
anticipate FDA qualification of our new manufacturing operations in early 2007.
General and Administrative Expenses (G&A): G&A expenses increased from $745,000 during the three
months ended September 2005 to $827,000 during the same period in 2006. Included in the 2006
period is a $126,000 non-cash, SFAS 123(R) charge for share-based employee compensation. Excluding
this charge, G&A expenses declined by $44,000, because of decreased personnel-related costs and
because during the three months ended September 2005, we incurred certain charges related to the
installation of our new information system and AMEX listing fees, offset by a $145,000 reversal of
bad debt expense.
Page 19
Research and Development Expenses (R&D): R&D expenses decreased from $1.0 million during the three
months ended September 2005 to $658,000 during the same period in 2006. Included in the 2006
period is an $8,000 non-cash, SFAS
123(R) charge for share-based employee compensation. We attribute the decrease to reduced
personnel costs of $248,000 and consulting expense of $163,000, offset by increased clinical costs
of $67,000 for an ongoing clinical study for our PTQ product and a study we launched during the
three months ended September 30, 2006 to compare the efficacy of the Urgent PC against a leading
drug therapy for treatment of overactive bladder symptoms. During the three months ended September
30, 2005, we incurred consulting expense primarily for the development of our second generation
Urgent PC product and a $205,000 expense related to severance compensation for our former Vice
President of Research and Development and Managing Director of our United Kingdom subsidiary.
Selling and Marketing Expenses (S&M): S&M expenses increased from $805,000 during the three months
ended September 30, 2005 to $1.3 million during the same period in 2006. Included in the 2006
period is a $13,000 non-cash, SFAS 123(R) charge for share-based employee compensation. We
attribute the increase to the $233,000 increase in compensation-related costs, primarily for our
U.S. direct sales force and marketing organization, the $105,000 increase in travel-related costs,
the $46,000 increase in promotional activities and an increase in other costs to support our
expanded sales organization and marketing activities.
Other Income (Expense): Other income (expense) includes interest income, interest expense, warrant
expense or benefit, foreign currency exchange gains and losses and other non-operating costs when
incurred. Our financial results are subject to material fluctuations based on changes in currency
exchange rates. Other income (expense) was $(690,000) and $718,000 for the three months ended
September 30, 2006 and 2005, respectively.
As a result of the suspension of the exercise of the 706,218 warrants we originally issued in July
2002, we granted a like number of new common stock purchase warrants to the holders of the expired
warrants in April 2005. The new warrants will be exercisable at $2.00 per share for 90 days after
the effective date of a registration statement covering the shares underlying these warrants.
Although as of September 30, 2006, we had filed this registration statement, the U.S. Securities
and Exchange Commission had not declared it effective. We anticipate seeking effectiveness of the
registration statement before the end of calendar year 2006. In April 2005, we recognized a
liability and a charge to equity of approximately $1.4 million associated with the grant of these
new warrants. The Company determined the fair value of these warrants using the Black-Scholes
option-pricing model. We have since reduced the reported liability by approximately $362,000 due
to the decrease in the fair value of these warrants from their date of issuance through September
30, 2006. We recorded a warrant expense of $700,000 for the three months ended September 30, 2006
and a warrant benefit of $702,000 for the three months ended September 30, 2005. We will continue
to remeasure the value of this liability in relation to its fair value and adjust accordingly until
such time as the warrants are exercised or expire.
We recognize exchange gains and losses primarily as a result of fluctuations in currency rates
between the U.S. dollar (the functional reporting currency) and the euro and British pound
(currencies of our subsidiaries), as well as their effect on the dollar denominated short-term
intercompany obligations between us and our foreign subsidiaries. We recognized foreign currency
gains (losses) of $4,000 and $(7,000) for the three months ended September 30, 2006 and 2005,
respectively.
Income Tax Expense: Our Dutch subsidiaries recorded income tax benefit of $13,000 and $34,000 for
the three months ended September 30, 2006 and 2005, respectively. For fiscal 2007, the Dutch income
tax rate is 25.5% for 22,689 (approximately $29,000) of profit and 29.6% for amounts above 22,689
compared to 27% and 31.5% in fiscal 2006, respectively.
Six months ended September 30, 2006 compared to six months ended September 30, 2005
Net Sales: During the six months ended September 30, 2006, net sales were $3.5 million,
representing a $324,000 or a 10% increase when compared to net sales of $3.2 million for the
six-months ended September 30, 2005. Excluding the impact of fluctuations in foreign currency
exchange rates, sales increased by approximately 7%. An 11% decline in sales of Macroplastique
products was more than offset by sales of the Urgent PC and an increase in sales of the I-Stop. In
the six months ended September 30, 2005, we had no sales of the Urgent PC and had minimal sales of
the I-Stop.
We attribute the decline in sales of the Macroplastique products primarily due to adverse changes
in the implementation of reimbursement policies by the governments in countries outside the U.S.,
and the increase in pricing competition. We expect this to adversely impact our future sales in
those markets. In response, we have implemented targeted volume price reductions, have increased
the number of training workshops targeted to our distributors and key incontinence surgeons, and
are sponsoring scientific podium presentations and seminars at the most highly recognized
international incontinence congresses. We cannot assure that these initiatives will increase
Macroplastique sales.
Page 20
Gross Profit: Gross profit was $2.5 million and $2.3 million for the six months ended September
30, 2006 and 2005, respectively, or 71% and 72% of net sales in the respective periods. We
attribute the decline in gross profit percent to lower manufacturing capacity utilization in the
first fiscal quarter due to the decline in Macroplastique sales and duplicate manufacturing
facilities in the U.S., offset partially by increased manufacturing capacity utilization in the
second fiscal quarter, as we stepped up production to build inventory to meet our needs during the
transition period when we relocate our manufacturing operations to our new corporate headquarters
in Minnetonka, MN. We expect to relocate the manufacturing operations in our third fiscal quarter
and anticipate FDA qualification of our new manufacturing operations in early 2007.
General and Administrative Expenses (G&A): G&A expenses increased from $1.4 million during the six
months ended September 30, 2005 to $1.7 million during the same period in 2006. Included in the
2006 period is a $392,000 non-cash, SFAS 123(R) charge for share-based employee compensation.
Excluding this charge, G&A expenses declined by $116,000, because of decreased personnel-related
costs offset by increased rent expense and because during the six months ended September 2005, we
incurred certain charges related to the installation of our new information system and AMEX listing
fees, offset by a $145,000 reversal of bad debt expense.
Research and Development Expenses (R&D): R&D expenses decreased from $1.7 million during the six
months ended September 30, 2005 to $1.3 million during the same period in 2006. Included in the
2006 period is a $17,000 non-cash, SFAS 123(R) charge for share-based employee compensation. We
attribute the decrease to decreased personnel-related costs of $213,000 and consulting expense of
$126,000, offset by increased clinical costs of $125,000 for an ongoing clinical study for our PTQ
product and for a study we launched during the three months ended September 30, 2006 to compare the
efficacy of the Urgent PC against a leading drug therapy for treatment of overactive bladder
symptoms. During the six months ended September 30, 2005 we incurred consulting expense primarily
for the development of our second generation Urgent PC product and a $205,000 expense related to
severance compensation for our former Vice President of Research and Development and Managing
Director of our United Kingdom subsidiary.
Selling and Marketing Expenses (S&M): S&M expenses increased from $1.5 million during the six
months ended September 30, 2005 to $2.5 million during the same period in 2006. Included in the
2006 period is a $37,000 non-cash, SFAS 123(R) charge for share-based employee compensation. We
attribute the increase to the $571,000 increase in compensation-related costs, primarily for our
U.S. direct sales force and marketing organization, the $176,000 increase in travel-related costs
and an increase in other costs to support our expanded organization and marketing activities.
Other Income (Expense): Other income (expense) includes interest income, interest expense, warrant
expense or benefit, foreign currency exchange gains and losses and other non-operating costs when
incurred. Our financial results are subject to material fluctuations based on changes in currency
exchange rates. Other income (expense) was $(318,000) and $53,000 for the six months ended
September 30, 2006 and 2005, respectively.
As a result of the suspension of the exercise of the 706,218 warrants we originally issued in July
2002, we granted a like number of new common stock purchase warrants to the holders of the expired
warrants in April 2005. The new warrants will be exercisable at $2.00 per share for 90 days after
the effective date of a registration statement covering the shares underlying these warrants.
Although as of September 30, 2006, we had filed this registration statement,, the U.S. Securities
and Exchange Commission had not declared it effective. We anticipate seeking effectiveness of the
registration statement before the end of calendar year 2006. In April 2005, we recognized a
liability and a charge to equity of approximately $1.4 million associated with the grant of these
new warrants. The Company determined the fair value of these warrants using the Black-Scholes
option-pricing model. We have since reduced the reported liability by approximately $362,000 due
to the decrease in the fair value of these warrants from their date of issuance through September
30, 2006. We recorded a warrant expense of $373,000 for the six months ended September 30, 2006
and a warrant benefit of $15,000 for the six months ended September 30, 2005. We will continue to
remeasure the value of this liability in relation to its fair value and adjust accordingly until
such time as the warrants are exercised or expire.
We 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 $30,000 and $(8,000) for the six-months ended September 30, 2006 and 2005,
respectively.
Income Tax Expense: Our Dutch subsidiaries recorded income tax expense of $18,000 and $3,000 for
the six-months ended September 30, 2006 and 2005, respectively. For fiscal 2007, the Dutch income
tax rate is 25.5% for 22,689 (approximately $29,000) of profit and 29.6% for amounts above 22,689
compared to 27% and 31.5% in fiscal 2006, respectively.
Page 21
Non-GAAP Financial Measures. In addition to disclosing the financial results for the three and six
months ended September 2006 calculated in accordance with U.S. generally accepted accounting
principles (GAAP), our discussion of the results of operations above contains non-GAAP financial
measures that exclude the effects of share-based employee compensation under the requirements of
FAS 123(R). The non-GAAP financial measures used by management and disclosed by us exclude the
income statement effects of share-based employee compensation under the requirements of FAS 123(R).
The non-GAAP financial measures disclosed by us should not be considered a substitute for, or
superior to, financial measures calculated in accordance with GAAP, and the consolidated financial
results calculated in accordance with GAAP and reconciliations to those financial statements should
be carefully evaluated. We may calculate our non-GAAP financial measures differently from
similarly titled measures used by other companies. Therefore, our non-GAAP financial measures may
not be comparable to those used by other companies. We have described the reconciliations of each
of our non-GAAP financial measures above to the most directly comparable GAAP financial measures.
Because we excluded FAS 123(R) share-based employee compensation expense in some of our discussion
above, these financial measures are treated as a non-GAAP financial measure under Securities and
Exchange Commission rules. Management uses our non-GAAP financial measures for internal managerial
purposes, including as a means to compare period-to-period results on a consolidated basis and as a
means to evaluate our results on a consolidated basis compared to those of other companies.
We disclose this information to the public to enable investors who wish to more easily assess our
performance on the same basis applied by management and to ease comparison on both a GAAP and
non-GAAP basis among peer companies.
Liquidity and Capital Resources
Cash Flows. As of September 30, 2006, our cash and cash equivalents balances totaled $2.0 million.
At September 30, 2006, we had working capital of approximately $1.9 million. For the six months
ended September 2006, we used $2.4 million of cash in operating activities, compared to $1.8
million of cash used in the same period a year ago. We attribute the increase in the use of cash
for operating activities primarily to the increase in loss and investment in working capital.
Sources of Liquidity. In April 2005, we conducted a private placement in which we sold 2,147,142
shares of our common stock at a price per share of $3.50, together with warrants to purchase
1,180,928 shares of our common stock, for an aggregate purchase price of approximately $7.5
million. The stock sale proceeds are offset by costs of approximately $935,000, resulting in net
proceeds of approximately $6.6 million. The warrants are exercisable for five years at an exercise
price of $4.75 per share.
In October 2006 we amended our business loan agreement with Venture Bank. The amended agreement
provides for a credit line of up to $500,000 secured by our assets and will expire in April 2007 if
not renewed. We may borrow up to 50% of the value of the inventory on hand in the U.S. and 75% of
the U.S. accounts receivable value. The bank charges interest on the loan at the rate of 1
percentage point over the prime rate (8.25% on September 30, 2006), subject to a minimum interest
rate of 7% per annum. In addition, Uroplasty BV, one of our subsidiaries entered into an
arrangement with Rabobank of The Netherlands for a 200,000 (approximately $258,500) credit line.
At September 30, 2006, we had no borrowings under any of our credit lines.
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 proceeds of
approximately $2.1 million. After offset for our estimated costs of $183,000, we received net
proceeds of $1.9 million. The warrants are exercisable for five years (but commencing 181 days
after closing) at an exercise price of $2.50 per share.
In May 2006, we also entered into a $100,000 3-year, term loan agreement with Venture Bank, at an
interest rate of 8.25% per annum. We used these proceeds for certain capital expenditures relating
to the relocation of our facility to our Minnetonka, Minnesota location.
Because we have yet to achieve profitability and generate positive cash flows, we need to raise
additional debt or equity financing in fiscal 2007 to continue funding for
product development and continued expansion of our sales and marketing activities. There can be
no guarantee that we will be successful, as we currently have no committed sources of, or other
arrangements with respect to, additional equity or debt financing. We
therefore cannot ensure that we will obtain additional financing on acceptable
terms, or at all. If we are unable to raise substantial funds in fiscal 2007, we will need to rely
on our
existing credit facilities and curtail our operations including product development, clinical
studies and sales and marketing activities in order to conserve cash and maintain our operations
through the balance of fiscal 2007. This would adversely impact our future business and prospects.
In any event, because we are not profitable, we will need to raise substantial additional
financing to support our operations and planned growth activities in fiscal 2008 and beyond.
Ultimately, we will need to achieve profitability and generate positive cash flows from operations
to fund our operations and grow our business.
Page 22
For the balance of fiscal 2007, we expect to incur significant research and development expenses,
including those in connection with clinical trials for the Urgent PC. We also expect that during
the balance of fiscal 2007, we will continue to incur significant expenses as we fund our selling
and marketing organization in the U.S. to market our products.
In April 2005, we entered into an exclusive manufacturing and distribution agreement with
CystoMedix for the Urgent PC product. The agreement required us to pay CystoMedix an initial
payment of $225,000 and an additional payment of $250,000 in 12 monthly installments of $20,833,
with the last installment payment made in the first quarter of fiscal 2007. We capitalized the
aggregate amount as licensed technology and are amortizing it over the term of the agreement. We
will also pay CystoMedix a 7% royalty on product sales. However, the 7% royalty is first offset
against the monthly royalty installments. Currently we do not project making any additional
royalty payments to CystoMedix in fiscal 2007.
CystoMedix has also granted us an exclusive option to acquire its assets. The purchase price is
$3,485,000, reduced by up to $50,000 of liabilities assumed by us. However, the $3,485,000 amount
used to compute the purchase price will increase at a rate of 10% per year after April 2007. The
purchase price is payable in shares of our common stock valued at the average of the closing bid
price of our shares for the 20 trading days prior to our exercise of the option. We may exercise
the option until June 2008. If we exercise the option, we will also assume up to $1.4 million of
bridge loan advances made to CystoMedix by its Chairman. We would repay up to $1.1 million of the
bridge loan advances at closing and would issue our common stock for the balance of the bridge loan
based on the above option price. We also have certain rights of first refusal to acquire
CystoMedixs assets in the event CystoMedix receives a third party offer in advance of any exercise
of our option. We will need to raise additional equity or debt funds in order to consummate the
CystoMedix acquisition, should we elect to do so.
We have two exclusive distribution agreements with CL Medical allowing us to market and sell the
I-Stop urethral sling: effective February 2006, a six-year agreement, with a right to renew it for
successive five-year terms, for distribution in the United States and, effective May 2005, a
one-year agreement with automatic renewal for up to two years, for distribution in the United
Kingdom. Under the agreements, we are required to purchase a minimum of $527,000 of units in the
first 12-month period following January 1, 2006, increasing to $2.7 million of units in the fifth
year of the agreement, for an aggregate commitment of approximately $6.9 million of units over the
five-year period, subject to periodic adjustment based on the value of the euro.
We were obligated to pay royalties of 5% of net sales of Macroplastique products in the U.S. with a
minimum of $50,000 per year. This royalty agreement expired on May 1, 2006. Under another royalty
agreement we pay royalties, in the aggregate, of three to five percent of net sales of
Macroplastique, Bioplastique, and PTQ Implants subject to a monthly minimum of $4,500. The
royalties payable under this agreement will continue until the patent referenced in the agreement
expires in 2010. Under a license agreement for the Macroplastique Implantation System, we pay a
royalty of 10 British pounds for each unit sold during the life of the patent.
We have a pension plan covering 14 employees in The Netherlands, reported as a defined benefit
plan. We pay premiums to an insurance company to fund annuities for these employees. However, we
are responsible for funding additional annuities based on continued service and future salary
increases. We closed this defined benefit plan for new employees in April 2005. As of that date,
the Dutch subsidiary established a defined contribution plan that now covers new employees. We also
closed our UK subsidiarys defined benefit plan to further accrual for all employees effective
December 31, 2004. In March 2005, the UK subsidiary established a defined contribution plan that
now covers new employees. As of September 30, 2006, we had an accrued pension liability of
$642,000.
In January 2006, we entered into a long-term lease with Liberty Property Limited Partnership for an
18,258 square foot facility for our U.S. headquarters located at 5420 Feltl Road, Minnetonka,
Minnesota. The lease effective date was May 1, 2006, has a term of 96 months, requires average
annual minimum rent payments of approximately $140,000 and requires payments for operating expenses
estimated to be approximately $82,000 in the first 12 months.
Page 23
Repayments of our contractual obligations as of September 30, 2006, consisting of royalties, notes
payable (inclusive of interest), and operating leases, are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Remainder |
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
|
|
|
|
|
of Fiscal |
|
|
2008 and |
|
|
2010 and |
|
|
2012 and |
|
|
|
Total |
|
|
2007 |
|
|
2009 |
|
|
2011 |
|
|
thereafter |
|
Minimum royalty payments |
|
$ |
220,500 |
|
|
$ |
27,000 |
|
|
$ |
108,000 |
|
|
$ |
85,500 |
|
|
$ |
|
|
Minimum purchase agreement |
|
|
6,601,542 |
|
|
|
377,587 |
|
|
|
2,112,719 |
|
|
|
4,111,236 |
|
|
|
|
|
Notes payable, including
interest |
|
|
672,860 |
|
|
|
86,363 |
|
|
|
192,522 |
|
|
|
107,045 |
|
|
|
286,930 |
|
Operating lease commitments |
|
|
1,453,844 |
|
|
|
128,535 |
|
|
|
471,504 |
|
|
|
366,330 |
|
|
|
487,475 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
8,948,746 |
|
|
$ |
619,485 |
|
|
$ |
2,884,745 |
|
|
$ |
4,670,111 |
|
|
$ |
774,405 |
|
|
|
|
|
|
|
|
|
|
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ITEM 3. CONTROLS AND PROCEDURES.
Disclosure Controls and Procedures. Within the 90 days prior to the date of this report, our
President and Chief Executive Officer and Chief Financial Officer carried out an evaluation of the
effectiveness of the design and operation of our disclosure controls and procedures pursuant to
Rule 13a-15b under the Securities Exchange Act of 1934. Based on this evaluation, these officers
concluded that our disclosure controls and procedures are effective to ensure that information
required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in Securities and Exchange
Commission rules and forms.
Internal Control Matters. We also maintain a system of internal accounting controls designed to
provide reasonable assurance that our books and records accurately reflect our transactions and
that our policies and procedures are followed. There have been no changes in our internal control
over financial reporting during the three months ended September 30, 2006, or thereafter, that have
materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
Any control system, no matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system are met. The design of a control
system inherently has limitations, and the benefits of controls must be weighed against their
costs. Additionally, controls can be circumvented by the individual acts of some persons, by
collusion of two or more people, or by management override of the control. Therefore, no evaluation
of a cost-effective system of controls can provide absolute assurance that all control issues and
instances of fraud, if any, will be detected.
Page 24
PART II. OTHER INFORMATION
Except as indicated below, none of the items contained in PART II of Form 10-QSB are applicable to
us for the three months ended September 30, 2006.
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On October 24, 2006 we held our 2006 Annual Meeting. At the meeting the shareholders approved the
proposals for the election of directors and amendment to our Restated Articles of Incorporation to
increase the number of authorized common shares from 20,000,000 to 40,000,000. A summary of the
voting is as follows:
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Abstentions |
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And |
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Votes |
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Votes |
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Votes |
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Broker Non- |
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For |
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Against |
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Withheld |
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Votes |
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Proposal 1 Election of
Directors: |
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David B. Kaysen |
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6,463,626 |
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27,800 |
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322,285 |
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Lee A. Jones |
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6,471,671 |
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19,755 |
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322,285 |
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Sven A. Wehrwein |
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6,263,822 |
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227,604 |
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322,285 |
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James P. Stauner |
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6,263,822 |
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227,604 |
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322,285 |
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Proposal 2 Amendment to
Restated Articles of
Incorporation: |
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6,158,706 |
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31,750 |
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300,968 |
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322,287 |
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ITEM 6. EXHIBITS.
(a) Exhibits
31.1 Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
32.1 Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (this Exhibit is furnished pursuant to SEC rules,
but is deemed not filed)
Page 25
SIGNATURES
In accordance with the requirements of the Securities Exchange Act of 1934, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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UROPLASTY, INC. |
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Date: November 9, 2006
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By:
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/s/ DAVID B. KAYSEN
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David B. Kaysen |
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President and Chief Executive Officer |
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Date: November 9, 2006
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By:
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/s/ MAHEDI A. JIWANI |
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Mahedi A. Jiwani |
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Chief Financial Officer |
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Page 26