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 June 30, 2007
Commission File No. 000-20989
UROPLASTY, INC.
(Name of Small Business Issuer in its Charter)
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Minnesota, U.S.A.
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41-1719250 |
(State or other jurisdiction of
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I.R.S. Employer |
incorporation or organization)
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(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 July 31, 2007 was
13,264,640.
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
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June 30, 2007 |
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(unaudited) |
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March 31, 2007 |
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Assets |
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|
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Current assets: |
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|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
3,204,684 |
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|
$ |
3,763,702 |
|
Short-term investments |
|
|
2,400,000 |
|
|
|
3,000,000 |
|
Accounts receivable, net |
|
|
1,775,607 |
|
|
|
1,240,141 |
|
Income tax receivable |
|
|
34,099 |
|
|
|
113,304 |
|
Inventories |
|
|
821,577 |
|
|
|
823,601 |
|
Other |
|
|
354,814 |
|
|
|
272,035 |
|
|
|
|
|
|
|
|
Total current assets |
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8,590,781 |
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|
9,212,783 |
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Property, plant, and equipment, net |
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1,459,165 |
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1,431,749 |
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|
|
|
|
|
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Intangible assets, net |
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4,845,177 |
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|
308,093 |
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|
|
|
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|
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Deferred tax assets |
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|
94,234 |
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|
93,819 |
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|
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|
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Total assets |
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$ |
14,989,357 |
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|
$ |
11,046,444 |
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|
See accompanying notes to the condensed consolidated financial statements.
Page 2
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
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June 30, 2007 |
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(unaudited) |
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March 31, 2007 |
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Liabilities and Shareholders Equity |
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Current liabilities: |
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Current maturities long-term debt |
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$ |
161,696 |
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$ |
78,431 |
|
Deferred rent current |
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|
35,000 |
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|
35,000 |
|
Accounts payable |
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|
449,635 |
|
|
|
544,507 |
|
Accrued liabilities |
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|
882,940 |
|
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|
1,347,670 |
|
|
|
|
|
|
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|
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|
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|
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Total current liabilities |
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1,529,271 |
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|
2,005,608 |
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Long-term debt less current maturities |
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411,935 |
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427,382 |
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Deferred rent less current portion |
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|
206,030 |
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214,381 |
|
Accrued pension liability |
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|
458,937 |
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596,026 |
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|
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|
|
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|
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Total liabilities |
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2,606,173 |
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3,243,397 |
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Shareholders equity: |
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Common stock $.01 par value;
40,000,000
shares authorized, 13,262,140 and
11,614,330 shares issued and
outstanding at June 30 and
March 31, 2007, respectively |
|
|
132,621 |
|
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|
116,143 |
|
Additional paid-in capital |
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|
29,382,285 |
|
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|
23,996,818 |
|
Accumulated deficit |
|
|
(16,851,625 |
) |
|
|
(16,010,990 |
) |
Accumulated other comprehensive loss |
|
|
(280,097 |
) |
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|
(298,924 |
) |
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|
|
|
|
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|
|
|
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|
|
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Total shareholders equity |
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12,383,184 |
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|
7,803,047 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total liabilities and shareholders equity |
|
$ |
14,989,357 |
|
|
$ |
11,046,444 |
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|
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|
|
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|
See accompanying notes to the condensed consolidated financial statements.
Page 3
UROPLASTY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended |
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June 30, |
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2007 |
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2006 |
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Net sales |
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$ |
2,948,674 |
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$ |
1,764,210 |
|
Cost of goods sold |
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594,212 |
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|
555,516 |
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Gross profit |
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2,354,462 |
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|
1,208,694 |
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Operating expenses |
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General and administrative |
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808,374 |
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|
857,572 |
|
Research and development |
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|
506,125 |
|
|
|
674,954 |
|
Selling and marketing |
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|
1,632,789 |
|
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|
1,232,587 |
|
Amortization of intangibles |
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|
216,521 |
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|
26,537 |
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|
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|
|
|
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3,163,809 |
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|
2,791,650 |
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Operating loss |
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|
(809,347 |
) |
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|
(1,582,956 |
) |
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|
|
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Other income (expense) |
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Interest income |
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|
76,383 |
|
|
|
19,507 |
|
Interest expense |
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|
(11,365 |
) |
|
|
(5,982 |
) |
Warrant benefit |
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|
327,732 |
|
Foreign currency exchange gain (loss) |
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|
(2,029 |
) |
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|
26,411 |
|
Other, net |
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|
1,879 |
|
|
|
4,800 |
|
|
|
|
|
|
|
|
|
|
|
64,868 |
|
|
|
372,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Loss before income taxes |
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|
(744,479 |
) |
|
|
(1,210,488 |
) |
|
|
|
|
|
|
|
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|
Income tax expense |
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|
96,156 |
|
|
|
30,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Net loss |
|
$ |
(840,635 |
) |
|
$ |
(1,241,239 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
Basic and diluted loss per common share |
|
$ |
(0.06 |
) |
|
$ |
(0.18 |
) |
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|
|
|
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|
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|
Weighted average common shares outstanding: |
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|
|
|
|
|
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|
Basic and diluted |
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|
12,981,466 |
|
|
|
6,952,167 |
|
See accompanying notes to the condensed consolidated financial statements.
Page 4
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS EQUITY AND COMPREHENSIVE LOSS
Three months ended June 30, 2007
(Unaudited)
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Accumulated |
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Additional |
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Other |
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Total |
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Common Stock |
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Paid-in |
|
|
Accumulated |
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|
Comprehensive |
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|
Shareholders |
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Shares |
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Amount |
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|
Capital |
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|
Deficit |
|
|
Loss |
|
|
Equity |
|
Balance at March 31, 2007 |
|
|
11,614,330 |
|
|
$ |
116,143 |
|
|
$ |
23,996,818 |
|
|
$ |
(16,010,990 |
) |
|
$ |
(298,924 |
) |
|
$ |
7,803,047 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Issuance of common stock
in connection with the
purchase of
intellectual property |
|
|
1,417,144 |
|
|
|
14,171 |
|
|
|
4,644,690 |
|
|
|
|
|
|
|
|
|
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|
4,658,861 |
|
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|
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|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
Proceeds from exercise
of warrants |
|
|
50,000 |
|
|
|
500 |
|
|
|
149,500 |
|
|
|
|
|
|
|
|
|
|
|
150,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Proceeds from exercise
of stock options |
|
|
180,666 |
|
|
|
1,807 |
|
|
|
424,191 |
|
|
|
|
|
|
|
|
|
|
|
425,998 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Share-Based Consulting
and Compensation |
|
|
|
|
|
|
|
|
|
|
167,086 |
|
|
|
|
|
|
|
|
|
|
|
167,086 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
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|
Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(840,635 |
) |
|
|
18,827 |
|
|
|
(821,808 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2007 |
|
|
13,262,140 |
|
|
$ |
132,621 |
|
|
$ |
29,382,285 |
|
|
$ |
(16,851,625 |
) |
|
|
($280,097 |
) |
|
$ |
12,383,184 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 5
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Three Months Ended June 30, 2007 and 2006
(Unaudited)
|
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|
Three Months Ended |
|
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|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(840,635 |
) |
|
$ |
(1,241,239 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
274,189 |
|
|
|
72,462 |
|
Gain on disposal of equipment |
|
|
(2,771 |
) |
|
|
(4,800 |
) |
Warrant benefit |
|
|
|
|
|
|
(327,732 |
) |
Stock-based consulting expense |
|
|
14,067 |
|
|
|
11,007 |
|
Stock-based compensation expense |
|
|
153,019 |
|
|
|
299,595 |
|
Deferred income taxes |
|
|
572 |
|
|
|
(21,495 |
) |
Deferred rent |
|
|
(8,750 |
) |
|
|
(5,833 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(524,327 |
) |
|
|
(178,338 |
) |
Inventories |
|
|
10,651 |
|
|
|
76,937 |
|
Other current assets and income tax receivable |
|
|
(926 |
) |
|
|
59,400 |
|
Accounts payable |
|
|
(97,291 |
) |
|
|
35,354 |
|
Accrued liabilities |
|
|
(472,737 |
) |
|
|
(207,646 |
) |
Accrued pension liability, net |
|
|
(145,556 |
) |
|
|
27,025 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(1,640,495 |
) |
|
|
(1,405,303 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Proceeds from sale of short-term investments |
|
|
600,000 |
|
|
|
1,137,647 |
|
Purchases of property, plant and equipment |
|
|
(89,287 |
) |
|
|
(91,825 |
) |
Proceeds from sale of equipment |
|
|
9,952 |
|
|
|
4,800 |
|
Payments for intangible assets |
|
|
(89,725 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
430,940 |
|
|
|
1,050,622 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from long-term obligations |
|
|
178,374 |
|
|
|
210,999 |
|
Repayment of long-term obligations |
|
|
(115,067 |
) |
|
|
(36,374 |
) |
Proceeds from issuance of common stock, warrants and option exercise |
|
|
575,998 |
|
|
|
12,798 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
639,305 |
|
|
|
187,423 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
11,232 |
|
|
|
(1,869 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
559,018 |
|
|
|
(169,127 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
3,763,702 |
|
|
|
1,563,433 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
3,204,684 |
|
|
$ |
1,394,306 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
9,099 |
|
|
$ |
7,081 |
|
Cash paid during the period for income taxes |
|
|
15,573 |
|
|
|
23,121 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash financing and investing activities: |
|
|
|
|
|
|
|
|
Employee retirement savings plan contribution issued in common shares |
|
|
|
|
|
$ |
44,408 |
|
Property, plant and equipment additions funded by lessor allowance and
classified as deferred rent |
|
|
|
|
|
|
280,000 |
|
Purchase of intellectual property funded by issuance of stock |
|
$ |
4,658,861 |
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
Page 6
UROPLASTY, INC. AND SUBSIDIARIES
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. Basis of Presentation
We have prepared our condensed consolidated financial statements included in this Form 10-QSB,
without audit, pursuant to the rules and regulations of the Securities and Exchange Commission.
Certain information and footnote disclosures normally included in the consolidated financial
statements prepared in accordance with accounting principles generally accepted in the United
States of America have been condensed or omitted, pursuant to such rules and regulations. The
consolidated results of operations for any interim period are not necessarily indicative of results
for a full year. These condensed consolidated financial statements should be read in conjunction
with the consolidated financial statements and related notes included in our Annual Report on Form
10-KSB for the year ended March 31, 2007.
The condensed consolidated financial statements presented herein as of June 30, 2007 and for the
three-month periods ended June 30, 2007 and 2006 reflect, in the opinion of management, all
material adjustments consisting only of normal recurring adjustments necessary for a fair
presentation of the consolidated financial position, results of operations and cash flows for the
interim periods.
We have identified certain accounting policies that we consider particularly important for the
portrayal of our results of operations and financial position and which may require the application
of a higher level of judgment by our management, and as a result are subject to an inherent level
of uncertainty. These are characterized as critical accounting policies and address revenue
recognition, accounts receivable, inventories, foreign currency translation and transactions,
impairment of long-lived assets, share-based compensation and income taxes, each of which is more
fully described in our Annual Report on Form 10-KSB for the year ended March 31, 2007. Based upon
our review, we have determined that these policies remain our most critical accounting policies for
the three month period ended June 30, 2007, and we have made no changes to these policies during
fiscal 2008.
2. Nature of Business, Sales of Common Stock and Corporate Liquidity
We are a medical device company that develops, manufactures and markets innovative, proprietary
products for the treatment of voiding dysfunctions. We offer minimally invasive products to treat
urinary and fecal incontinence and overactive bladder symptoms. In addition, we market soft tissue
bulking material for additional indications, including the treatment of vocal cord rehabilitation,
fecal incontinence and soft tissue facial augmentation. We sell our products in and outside of the
United States. In fiscal 2007, we expanded our sales, marketing and reimbursement organizations in
the U.S. to market the products directly to the customers.
In October 2006, we received from the FDA pre-market approval for Macroplastique®, a minimally
invasive, implantable soft tissue bulking agent for the treatment of urinary incontinence, sold in
over 40 countries outside the United States since 1991. We began marketing this product in the
United States in early 2007.
The majority of our revenue is from products sold outside of the United States. We have
established a sales force in the United States to commercialize these products and anticipate
increasing our sales and marketing organization. We expect our sales in the U.S. to grow faster
than the overall sales growth in the next few years.
Our future liquidity and capital requirements will depend on numerous factors including: acceptance
of our products, and the timing and cost involved in manufacturing scale-up and in expanding our
sales, marketing and distribution capabilities, in the United States markets; the cost and
effectiveness of our marketing and sales efforts with respect to our existing products in
international markets; the effect of competing technologies and market and regulatory developments;
and the cost involved in protecting our proprietary rights. Because we have yet to achieve
profitability and generate positive cash flows, we will need to raise additional debt or equity
financing to continue funding for product development, to continue expansion of our sales and
marketing activities and for planned growth activities beyond fiscal 2008. There can be no
guarantee that we will be successful, as we currently have no committed sources of, or other
arrangements with respect to, additional equity or debt financing, aside from the recently
established credit lines. We therefore cannot ensure that we will obtain additional financing on
acceptable terms, or at all. Ultimately, we will need to achieve profitability and generate
positive cash flow from operations to fund our operations and grow our business.
Page 7
In May 2007, we amended our business loan agreement with Venture Bank. The agreement, expiring in
May 2008, provides for a credit line of up to $1 million secured by our assets. We may borrow up
to 50% (to a maximum of $500,000) of the value of our eligible inventories on hand in the U.S. and
80% of our eligible U.S. accounts receivable value. To borrow any amount, we must maintain
consolidated net equity of at least equal to $3.5 million as well as maintain certain other
financial covenants on a quarterly basis. The bank charges interest on the loan at a per annum
rate of the greater of 7.5% or one percentage point over the prime rate (8.25% on June 30, 2007).
In addition, Uroplasty BV, our subsidiary, entered into an agreement with Rabobank of The
Netherlands for a 500,000 (approximately $667,000) credit line. The bank charges interest on
the loan at the rate of one percentage point over the Rabobank base interest rate (5.25% on June
30, 2007), subject to a minimum interest rate of 3.5% per annum. At June 30, 2007, we had no
borrowings outstanding under any of our credit lines.
3. Short-term Investments
At June 30, 2007, short-term investments consisted of certificates of deposit of which $1,200,000
will mature in the second quarter of fiscal 2008 and $1,200,000 will mature in the third quarter of
fiscal 2008.
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:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
March 31, 2007 |
|
Raw materials |
|
$ |
239,026 |
|
|
$ |
254,988 |
|
Work-in-process |
|
|
26,249 |
|
|
|
20,773 |
|
Finished goods |
|
|
556,302 |
|
|
|
547,840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
821,577 |
|
|
$ |
823,601 |
|
|
|
|
|
|
|
|
5. Intangible Assets
Intangible assets are comprised of patents, trademarks and licensed technology which are amortized
on a straight-line basis over their estimated useful lives or contractual terms, whichever is less.
In April 2007, we acquired from CystoMedix, Inc. certain intellectual property assets related to
the Urgent PC® neuromodulation system, which was previously licensed to us. In consideration, we
issued CystoMedix 1,417,144 shares of our common stock. We have capitalized $4.7 million of the
acquisition costs as patents and inventions.
The following is a summary of intangible assets at June 30, 2007 and March 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
|
Estimated |
|
|
Gross |
|
|
|
|
|
|
|
|
|
Useful Lives |
|
|
Carrying |
|
|
Accumulated |
|
|
|
|
|
|
(Years) |
|
|
Amount |
|
|
Amortization |
|
|
Net value |
|
Licensed technology |
|
5 |
|
|
$ |
26,290 |
|
|
$ |
26,290 |
|
|
$ |
|
|
Patents and inventions |
|
6 |
|
|
|
5,461,486 |
|
|
|
616,309 |
|
|
|
4,845,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
|
|
|
|
$ |
5,487,776 |
|
|
$ |
642,599 |
|
|
$ |
4,845,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2007
|
|
|
|
|
|
|
|
Licensed technology |
|
5 |
|
|
$ |
26,290 |
|
|
$ |
26,290 |
|
|
$ |
|
|
Patents and inventions |
|
6 |
|
|
|
712,900 |
|
|
|
404,807 |
|
|
|
308,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
|
|
|
|
$ |
739,190 |
|
|
$ |
431,097 |
|
|
$ |
308,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Page 8
Estimated annual amortization for these assets for the fiscal years ended March 31 is as follows:
|
|
|
|
|
Remainder of fiscal 2008 |
|
$ |
634,505 |
|
2009 |
|
|
845,903 |
|
2010 |
|
|
843,619 |
|
2011 + |
|
|
2,521,150 |
|
|
|
|
|
|
|
$ |
4,845,177 |
|
|
|
|
|
6. Deferred Rent
We entered into an 8-year operating lease agreement, effective May 2006, for our corporate
facility. As part of the agreement, the landlord provided an incentive of $280,000 for leasehold
improvements. This incentive was recorded as deferred rent and is being amortized as reduction in
lease expense over the lease term in accordance to SFAS 13, Accounting for Leases and FASB
Technical Bulletin 88-1, Issues Relating to Accounting for Leases. The leasehold improvements
are amortized and charged to expense over the shorter of asset life or the lease term.
7. Comprehensive Loss
Comprehensive loss consists of net loss, translation adjustments and additional pension liability
as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
Net loss |
|
$ |
(840,635 |
) |
|
$ |
(1,241,239 |
) |
Items of other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
22,127 |
|
|
|
96,589 |
|
Pension related |
|
|
(3,300 |
) |
|
|
(11,403 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(821,808 |
) |
|
$ |
(1,156,053 |
) |
|
|
|
|
|
|
|
8. Net Loss per Common Share
The following options and warrants outstanding at June 30, 2007 and 2006, to purchase shares of
common stock, were excluded from diluted loss per common share because of their anti-dilutive
effect:
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Range of Exercise |
|
|
|
Options/Warrants |
|
|
Prices |
|
For the three months ended: |
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
4,131,178 |
|
|
$1.10 to $5.30 |
June 30, 2006 |
|
|
4,038,460 |
|
|
$0.90 to $10.50 |
9. Warrants
As of June 30, 2007, we had issued and outstanding warrants to purchase an aggregate of
2,166,478 common shares, at a weighted average exercise price of $3.81.
In connection with our equity offerings of April 2005 private placement, August 2006 private
placement and December 2006 follow-on public offering, we issued five-year warrants to purchase
1,180,928, 764,500 and 121,050 common shares, respectively, at exercise prices of $4.75, $2.50 and
$2.40 per share, respectively.
Page 9
As part of a consulting agreement, we have outstanding five-year warrants, issued in November 2003
to CCRI Corporation, to purchase 50,000 shares of common stock at a per share price of $5.00.
Proceeds from the exercise of warrants were $150,000 for the three months ended June 30, 2007.
10. Share-based Compensation
As of December 31, 2006, we had one active plan (2006 Stock and Incentive Plan) for share-based
compensation awards. Under the plan, if we have a change in control, all outstanding awards,
including those subject to vesting or other performance targets, fully vest immediately. We have
reserved 1,200,000 shares of our common stock for stock-based awards under this plan, and as of
June 30, 2007, we had granted awards for 401,000 options. We generally grant option awards with an
exercise price equal to the closing market price of our stock at the date of the grant.
We account for share-based compensation costs under Statement of Financial Accounting Standards No.
123(R), Share-Based PaymentRevised 2004. We incurred a total of approximately $153,000 and
$300,000 in compensation expense for the three months ended June 30, 2007 and 2006, respectively.
Proceeds from the exercise of stock options were $426,000 for the three months ended June 30, 2007.
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
months ended June 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
June 30, 2007 |
|
|
June 30, 2006 |
|
|
|
|
Expected life in years |
|
|
4.35 |
|
|
|
8.97 |
|
Risk-free interest rate |
|
|
4.67 |
% |
|
|
5.06 |
% |
Expected volatility |
|
|
108.28 |
% |
|
|
100.26 |
% |
Expected dividend yield |
|
|
0 |
|
|
|
0 |
|
Weighted-average fair value |
|
|
3.34 |
|
|
|
2.18 |
|
The expected life selected for options granted during the quarter represents the period of time
that we expect our options to be outstanding based on historical data of option holder exercise and
termination behavior for similar grants. The risk-free interest rate for periods within the
contractual life of the option is based on the U.S. Treasury rate over the expected life at the
time of grant. Expected volatilities are based upon historical volatility of our stock. We
estimate the forfeiture rate for stock awards of up to 10.9% in 2008 based on the historical
employee turnover rates. The expected life of the options is based on the historical life of
previously granted options, which are generally held to maturity.
As of June 30, 2007, we had approximately $639,000 of unrecognized compensation cost related to
share-based payments that we expect to recognize over a weighted-average period of 1.64 years.
The following table summarizes the activity related to our stock options during the three months
ended June 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Avg. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Contractual |
|
|
Aggregate |
|
|
|
|
|
|
|
Avg. Exercise |
|
|
Life |
|
|
Intrinsic |
|
|
|
Number of Shares |
|
|
Price |
|
|
(Years) |
|
|
Value |
|
Options outstanding at beginning of period |
|
|
2,169,866 |
|
|
$ |
3.62 |
|
|
|
4.93 |
|
|
|
|
|
Options granted |
|
|
35,000 |
|
|
|
4.40 |
|
|
|
4.87 |
|
|
|
|
|
Options exercised |
|
|
(180,666 |
) |
|
|
2.36 |
|
|
|
|
|
|
|
|
|
Options surrendered |
|
|
(9,500 |
) |
|
|
2.49 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at end of period |
|
|
2,014,700 |
|
|
$ |
3.75 |
|
|
|
5.05 |
|
|
$ |
1,969,850 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of period |
|
|
1,638,199 |
|
|
$ |
4.01 |
|
|
|
4.86 |
|
|
$ |
1,347,916 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Page 10
11. Savings and Retirement Plans
We sponsor various plans for eligible employees in the United States, the United Kingdom (UK), and
The Netherlands.
Our retirement savings plan in the United States conforms to Section 401(k) of the Internal Revenue
Code and participation is available to substantially all employees. We made no discretionary
contributions in association with these plans in the United States for the quarter ended June 30,
2007. For the quarter ended June 30, 2006, we made a contribution of $44,408 in the form of our
fully vested common stock.
Our international subsidiaries have defined benefit retirement plans for eligible employees. These
plans provide benefits based on the employees years of service and compensation during the years
immediately preceding retirement, termination, disability, or death, as defined in the plans. We
froze the UK subsidiarys defined benefit plan on December 31, 2004 and established a defined
contribution plan on March 10, 2005. Effective April 1, 2005, we closed The Netherlands
subsidiarys defined benefit retirement plan for new participants and established a defined
contribution plan for new employees.
The cost for our defined benefit retirement plans in The Netherlands and the United Kingdom
includes the following components for the three months ended June 30, 2007 and 2006:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
Gross service cost |
|
$ |
21,258 |
|
|
$ |
50,542 |
|
Interest cost |
|
|
22,485 |
|
|
|
30,413 |
|
Expected return on assets |
|
|
(16,578 |
) |
|
|
(17,444 |
) |
Amortization |
|
|
1,590 |
|
|
|
10,431 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic retirement cost |
|
$ |
28,755 |
|
|
$ |
73,942 |
|
|
|
|
|
|
|
|
Major assumptions used in the above calculations include:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
Discount rate |
|
|
4.90-5.30 |
% |
|
|
4.25-5.50 |
% |
Expected return on assets |
|
|
4.90-5.00 |
% |
|
|
4.00-5.00 |
% |
Expected rate of increase in future
compensation: |
|
|
|
|
|
|
|
|
General |
|
|
3 |
% |
|
|
3 |
% |
Individual |
|
|
0%-3 |
% |
|
|
0%-3 |
% |
12. Foreign Currency Translation
We translate all assets and liabilities using period-end exchange rates. We translate statements
of operations items using average exchange rates for the period. We record the resulting
translation adjustment within accumulated other comprehensive loss, a separate component of
shareholders equity. We recognize foreign currency transaction gains and losses in our
consolidated statements of operations, including unrealized gains and losses on short-term
intercompany obligations using period-end exchange rates. We recognize unrealized gains and losses
on long-term intercompany obligations within accumulated other comprehensive loss, a separate
component of shareholders equity.
We recognize exchange gains and losses primarily as a result of fluctuations in currency rates
between the U.S. dollar (the functional reporting currency) and the Euro and British pound
(currencies of our subsidiaries), as well as their effect on the dollar denominated intercompany
obligations between us and our foreign subsidiaries. All intercompany balances are revolving in
nature and we do not deem them to be long-term balances. For the three months ended June 30, 2007
and 2006, we recognized foreign currency gain (loss) of $(2,029) and $26,411, respectively.
Page 11
13. Income Tax Expense
During the three months ended June 30, 2007 and 2006, our Dutch subsidiaries recorded income tax
expense of $95,856 and $30,751, respectively. During the three months ended June 30, 2007 and
2006, our U.S. organization recorded income tax expense of $300 and $0, respectively. We cannot
use our U.S. net operating loss carry forwards to offset taxable income in foreign jurisdictions.
Effective January 1, 2007, the maximum Dutch income tax rate is 25.5% for taxable income in excess
of 60,000.
Effective April 1, 2007, we adopted FASB Interpretation No. 48 (FIN 48), Accounting for
Uncertainty in Income Taxes an Interpretation of FASB Statement 109, which prescribes a
recognition threshold and a measurement attribute for financial statement recognition of tax
positions taken or expected to be taken in a tax return. It is managements responsibility to
determine whether it is more-likely than-not that a tax position will be sustained upon
examination, including resolution of any related appeals or litigation processes, based on the
technical merits of the position. At the adoption date of April 1, 2007, we had no unrecognized
tax benefits which needed to be adjusted for. As of June 30, 2007, we reviewed all income tax
positions taken or expected to be taken for all open tax years and determined that our income tax
positions are appropriately stated and supported for all open years and that the adoption of FIN 48
did not have a material effect on the our financial statements for the three months ended June 30,
2007.
We would recognize interest and penalties accrued on unrecognized tax benefits as well as interest
received from favorable tax settlements within income tax expense. At the adoption date of April
1, 2007, we recognized no interest or penalties related to uncertain tax positions. As of June 30,
2007, we recorded no accrued interest or penalties related to uncertain tax positions.
The fiscal tax years 2004 through 2007 remain open to examination by the Internal Revenue Service
and various state taxing jurisdictions to which we are subject. In addition, we are subject to
examination by certain foreign taxing authorities for which the fiscal years 2005 through 2007
remain open for examination.
We expect no significant change in the amount of unrecognized tax benefit, accrued interest or
penalties within the next 12 months.
14. Business Segment and Geographic Information
We are a medical device company that develops, manufactures and markets innovative, proprietary
products for the treatment of voiding dysfunctions. We offer minimally invasive products to treat
urinary incontinence and overactive bladder symptoms, as well as products to treat fecal
incontinence. We market our soft tissue bulking material for additional indications, including the
treatment of vocal cord rehabilitation and soft tissue facial augmentation. In addition, we
distribute specialized wound care products in The Netherlands and United Kingdom. We sell our
products in and outside of the United States. We recently expanded our sales, marketing and
reimbursement organizations in the U.S.
Based upon the above, we operate in only one reportable segment consisting of medical products,
primarily for the voiding dysfunctions market served by urologists, urogynecologists,
gynecologists and colorectal surgeons.
Information regarding operations in different geographies for the three months ended June 30, 2007
and 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United |
|
The |
|
United |
|
|
|
|
|
|
States |
|
Netherlands |
|
Kingdom |
|
Eliminations * |
|
Consolidated |
Fiscal 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, three months
ended June 30, 2007 |
|
$ |
1,350,794 |
|
|
$ |
1,736,778 |
|
|
$ |
515,653 |
|
|
$ |
(654,551 |
) |
|
$ |
2,948,674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense,
three months ended
June 30, 2007 |
|
|
300 |
|
|
|
95,856 |
|
|
|
|
|
|
|
|
|
|
|
96,156 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss),
three months ended
June 30, 2007 |
|
|
(1,197,344 |
) |
|
|
290,366 |
|
|
|
(62,735 |
) |
|
|
129,078 |
|
|
|
(840,635 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets
At June 30, 2007 |
|
|
5,562,951 |
|
|
|
734,575 |
|
|
|
6,816 |
|
|
|
|
|
|
|
6,304,342 |
|
Page 12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United |
|
The |
|
United |
|
|
|
|
|
|
States |
|
Netherlands |
|
Kingdom |
|
Eliminations * |
|
Consolidated |
Fiscal 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, three months
ended June 30, 2006 |
|
$ |
298,300 |
|
|
$ |
1,163,129 |
|
|
$ |
529,437 |
|
|
$ |
(226,656 |
) |
|
$ |
1,764,210 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense,
three months ended
June 30, 2006 |
|
|
|
|
|
|
30,751 |
|
|
|
|
|
|
|
|
|
|
|
30,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss),
three months ended
June 30, 2006 |
|
|
(1,347,945 |
) |
|
|
107,927 |
|
|
|
(57,675 |
) |
|
|
56,454 |
|
|
|
(1,241,239 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets
At June 30, 2006 |
|
|
1,079,198 |
|
|
|
747,365 |
|
|
|
4,282 |
|
|
|
|
|
|
|
1,830,845 |
|
|
|
|
* |
|
The information in the column entitled Eliminations represents intercompany transactions. |
15. Recently Issued Accounting Standards
In September 2006, the Financial Accounting Standards Board, or FASB, issued SFAS No. 157, Fair
Value Measurements (SFAS No. 157). SFAS No. 157 establishes a common definition for fair value to
be applied to US GAAP guidance requiring use of fair value, establishes a framework for measuring
fair value, and expands disclosure about such fair value measurements. SFAS No. 157 is effective
for fiscal years beginning after November 15, 2007. We are currently assessing the impact of SFAS
No. 157 but do not believe the adoption will have a significant impact on our financial position
and results of operations.
On February 15, 2007, the FASB, issued SFAS No. 159, The Fair Value Option for Financial Assets
and Financial Liabilities. Under SFAS No. 159, we may elect to report financial instruments and
certain other items at fair value on a contract-by-contract basis with changes in value reported in
earnings. This election is irrevocable. SFAS No. 159 provides an opportunity to mitigate
volatility in reported earnings that is caused by measuring hedged assets and liabilities that were
previously required to use a different accounting method than the related hedging contracts when
the complex hedge accounting provisions of SFAS No. 133, Accounting for Derivative Instruments and
Hedging Activities, are not met. SFAS No. 159 is effective for years beginning after November 15,
2007. If we adopt this standard, it does not expect to have a material effect on our financial
statements.
Page 13
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We recommend that you read this Report on Form 10-QSB in conjunction with our Annual Report on Form
10-KSB for the year ended March 31, 2007.
Forward-looking Statements
We may from time to time make written or oral forward-looking statements, including our
statements contained in this filing with the Securities and Exchange Commission and in our reports
to stockholders, as well as elsewhere. Forward-looking statements are statements such as those
contained in projections, plans, objectives, estimates, statements of future economic performance,
and assumptions related to any of the foregoing, and may be identified by the use of
forward-looking terminology, such as may, expect, anticipate, estimate, goal, continue,
or other comparable terminology. By their very nature, forward-looking statements are subject to
known and unknown risks and uncertainties relating to our future performance that may cause our
actual results, performance, or achievements, or industry results, to differ materially from those
expressed or implied in any such forward-looking statements. Any such statement is qualified by
reference to the following cautionary statements.
Our business operates in highly competitive markets and is subject to changes in general economic
conditions, competition, customer and market preferences, government regulation, the impact of tax
regulation, foreign exchange rate fluctuations, the degree of market acceptance of products, the
uncertainties of potential litigation, as well as other risks and uncertainties detailed elsewhere
herein and from time to time in our Securities and Exchange Commission filings.
In this filing, the section entitled Managements Discussion and Analysis of Financial Condition
and Results of Operations contains forward-looking statements. Various factors and risks (not all
of which are identifiable at this time) could cause our results, performance, or achievements to
differ materially from that contained in our forward-looking statements, and investors are
cautioned that any forward-looking statement contained herein or elsewhere is qualified by and
subject to the warnings and cautionary statements contained above and in our other filings with the
Securities and Exchange Commission.
We do not undertake, nor assume obligation, to update any forward-looking statement that we may
make from time to time.
Overview
We are a medical device company that develops, manufactures and markets innovative, products
for the treatment of voiding dysfunctions. Our minimally invasive products treat urinary and fecal
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 continuing to expand 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 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 markets, the U.S. is a significant opportunity for future sales of our
products. In order to grow our U.S. business, we have expanded our sales organization
(consisting of direct field personnel and independent sales
representatives) and marketing organization, and reimbursement department 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 14
|
|
|
|
Educate physicians and patients about the benefits of our Urgent PC neuromodulation
system. We believe education of physicians and patients regarding the benefits of our
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. 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 Implants is a minimally invasive, implantable soft tissue bulking agent for the
treatment of urinary incontinence. When Macroplastique is injected into tissue around the urethra,
it stabilizes and bulks tissues close to the urethra, thereby providing the surrounding muscles
with increased capability to control the release of urine. Macroplastique has been sold for
urological indications in over 40 countries outside the United States since 1991. In October 2006,
we received from the FDA pre-market approval for Macroplastique. We began marketing this product
in the United States in early calendar 2007. We cannot assure that we can market Macroplastique
profitability in the U.S. Our other proprietary, implantable soft tissue bulking agents that we
sell outside the United States include PTQ Implants for fecal incontinence, VOX Implants for vocal
cord rehabilitation and Bioplastique Implants for dermal augmentation.
The Urgent PC neuromodulation system is a minimally invasive device designed for office-based
treatment of overactive bladder symptoms of urinary 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
launched our second generation Urgent PC product in calendar 2006.
I-StopTM 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. We stopped selling this product in the U.S. in March
2007, but continue selling it in the United Kingdom.
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
direct field sales personnel and independent sales representatives), a marketing organization and a
reimbursement department to market our products directly to our customers. By continuing to expand
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 sales organization in the United Kingdom and primarily
through distributors in other markets.
Page 15
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 recognize revenue upon shipment of product to
our distributors and direct customers. We have no customer acceptance provisions or installation
obligations. Our sales terms to our distributors and customers provide no right of return outside
of our standard warranty, and payment terms consistent with industry standards apply. Sales terms
and pricing to our distributors are governed by the respective distribution agreements. Our
distributors purchase our products to meet the sales demand of their end-user customers as well as
to fulfill their internal requirements associated with the sales process and, if applicable,
contractual purchase requirements under the respective distribution agreements. Internal and other
requirements include purchases of products for training, demonstration and evaluation purposes,
clinical evaluations, product support, establishing inventories, and meeting minimum purchase
commitments. As a result, the level of our net sales during any period is not necessarily
indicative of our distributors sales to end-user customers during that period, which we estimate
are not substantially different than our sales to those distributors in each of the three-month
periods ended June 30, 2007 and 2006. Our distributors level of inventories of our products,
their sales to end-user customers and their internal product requirements may impact our future
revenue growth.
Accounts Receivable. We carry our accounts receivable at the original invoice amount less an
estimate made for doubtful receivables based on a periodic review of all outstanding amounts. We
determine the allowance for doubtful accounts based on customer health, and both historical and
expected credit loss experience. We write off our accounts receivable when we deem them
uncollectible. We record recoveries of accounts receivable previously written off when received.
Inventories. We state inventories at the lower of cost or market using the first-in, first-out
method. We provide lower of cost or market reserves for slow moving and obsolete inventories based
upon current and expected future product sales and the expected impact of product transitions or
modifications. While we expect our sales to grow, a reduction in sales could reduce the demand for
our products and may require additional inventory reserves.
Foreign Currency Translation/Transactions. We translate the financial statements of our foreign
subsidiaries in accordance with the provisions of SFAS No. 52 Foreign Currency Translation.
Under this Statement, we translate all assets and liabilities using period-end exchange rates, and
we translate statements of operations items using average exchange rates for the period. We record
the resulting translation adjustment within accumulated other comprehensive loss, a separate
component of shareholders equity. We recognize foreign currency transaction gains and losses in
the statement of operations, including unrealized gains and losses on short-term intercompany
obligations using period-end exchange rates, resulting in an increase in the volatility of our
consolidated statements of operations. We recognize unrealized gains and losses on long-term
intercompany obligations within accumulated other comprehensive loss, a separate component of
shareholders equity.
Impairment of Long-Lived Assets. Long-lived assets at June 30, 2007 consist of property, plant and
equipment and intangible assets. We review our long-lived assets for impairment whenever events or
business circumstances indicate that the carrying amount of an asset may not be recoverable. We
measure the recoverability of assets to be held and used by a comparison of the carrying amount of
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, or
SFAS 123(R). SFAS 123(R) requires that we recognize the compensation cost relating to share-based
payment transactions, including grants of employee stock options, in our financial statements. We
measure that cost based on the fair value of the equity or liability instruments issued. SFAS
123(R) covers a wide range of share-based compensation arrangements including stock options,
restricted share plans, performance-based awards, share appreciation rights, and employee share
purchase plans.
Page 16
This Statement requires us to measure the cost of employee services received in exchange for stock
options based on the grant-date fair value of the award, and to recognize the cost over the period
we require our employee to provide services for the award.
Defined Benefit Pension Plans. We have a liability attributed to defined benefit pension plans we
offered to certain former and current employees prior to April 2005. We pay premiums to an
insurance company to fund annuities and are responsible for funding additional annuities based on
continued service and future salary increases for these employees pension benefit. The liability
is dependent upon numerous factors, assumptions and estimates, and the continued benefit costs we
incur may be significantly affected by changes in key actuarial assumptions such as the discount
rate, compensation rates, or retirement dates used to determine the projected benefit obligation.
Additionally, changes made to the provisions of the plans may impact current and future benefit
costs. In accordance with accounting rules, changes in benefit obligations associated with these
factors may not be immediately recognized as costs on the income statement, but are recognized in
future years over the remaining average service period of plan participants.
Income Taxes. We recognize deferred tax assets and liabilities for future tax consequences
attributable to differences between the financial carrying amounts of existing assets and
liabilities and their respective tax bases. We measure deferred tax assets and liabilities using
enacted tax rates we expect to apply to taxable income in the years in which we expect to recover
or settle those temporary differences. As of March 31, 2007, we have generated approximately $18
million in U.S. net operating loss carryforwards that we cannot use to offset taxable income in
foreign jurisdictions. We recognize a valuation allowance when we determine it is more likely than
not that we will not realize 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, future utilization of NOL carryforwards are subject to certain limitations under
Section 382 of the Internal Revenue Code. This section generally relates to a 50 percent change in
ownership of a company over a three-year period. We believe that the issuance of our common stock
in the December 2006 follow-on public offering resulted in an ownership change under Section 382.
Accordingly, our ability to use NOL tax attributes generated prior to December 2006 may be
limited.
Set forth below is managements discussion and analysis of the financial condition and results of
operations for the three months ended June 30, 2007 and 2006. See Note 14 to our condensed
consolidated financial statements for business segment information.
Results of Operations
Three months ended June 30, 2007 compared to three months ended June 30, 2006
Net Sales: During the three months ended June 30, 2007, net sales were $2.9 million, representing
a $1.2 million or a 67% increase compared to net sales of $1.8 million for the three months ended
June 30, 2006. Excluding the impact of fluctuations in foreign currency exchange rates, sales
increased by approximately 62%. We attribute approximately three-fourths of the $1.2 million
increase to the growth in sales to our customers in the U.S.
We attribute the increase in sales primarily to our U.S. sales organization, and the continued
growth in sales of our Urgent PC product. Also, in the first quarter of fiscal 2008, sales outside
of the U.S. of our Macroplastique product increased, which we attribute to our increased marketing
focus.
Sales to customers in the U.S. for the first quarter of fiscal 2008 increased to $1.0 million from
$103,000 in the first quarter of fiscal 2007. Sales for the three months ended June 30, 2007,
represent a sequential, quarter-to-quarter increase from $705,000 in the previous quarter. We
attribute this growth primarily to the Urgent PC product and the fully established sales
organization. During the first quarter of fiscal 2008, we had minimal sales of our Macroplastique
product in the U.S., which we launched in early 2007, and the I-Stop product, which we
discontinued.
Gross Profit: Gross profit was $2.4 million and $1.2 million for the three months ended June 30,
2007 and 2006, respectively, or 80% and 69% of net sales in the respective periods. We attribute
the lower gross profit percentage in the first quarter of fiscal 2007 primarily to lower
manufacturing capacity utilization due to decline in Macroplastique sales, duplicate manufacturing
facilities in the U.S. pending completion of our relocation to our new corporate headquarters,
higher costs for our new facility, write-off of our first generation UPC products and an increase
in personnel-related costs. We attribute the higher gross profit percentage in the first quarter
of fiscal 2008 primarily to a favorable impact of approximately 3 percentage point due to increased
manufacturing capacity utilization as a result of increased sales, savings of
Page 17
approximately
$90,000 due to the closing of our Eindhoven, The Netherlands manufacturing facility, and an
increase in average selling price for our UPC product group. We expect the gross profit percentage
to be in the range of 73% to 78%, excluding any unusual charges, in the remaining quarters of the
current fiscal year, though change in the product mix we sell can shift the overall gross margin.
General and Administrative Expenses (G&A): G&A expenses decreased from $858,000 during the three
months ended June 30, 2006 to $808,000 during the same period in 2007. Included in the first
quarter of fiscal 2007 is a $266,000 non-cash, SFAS 123(R) charge for share-based employee
compensation, compared with a charge of $93,000 in the first quarter of fiscal 2008. Excluding
share based compensation charges, G&A expenses increased by $123,000, primarily because of an
increase in personnel-related costs and professional fees, offset by a reduction in rent expense
for our leased facilities in the United Kingdom and the U.S.
Research and Development Expenses (R&D): R&D expenses decreased from $675,000 during the three
months ended June 30, 2006 to $506,000 during the same period in 2007. We attribute the decrease
primarily to reduced consulting expense of $110,000. During the three months ended June 30, 2006,
we incurred consulting expense associated with introducing our second generation Urgent PC product
and regulatory expenses related to the relocation of our facility in Minnesota.
Selling and Marketing Expenses (S&M): S&M expenses increased from $1.2 million during the three
months ended June 30, 2006 to $1.6 million during the same period in 2007. We attribute the
increase to a $100,000 increase in compensation-related costs, primarily as a result of increased
salaries and bonuses, and a $230,000 increase in commissions for sales agents and independent sales
representatives.
Amortization of Intangibles: Amortization of intangibles increased from $27,000 during the three
months ended June 30, 2006 to $217,000 during the same period in 2007. In April 2007, we acquired
from CystoMedix, Inc., certain intellectual property assets related to the Urgent PC
neuromodulation system for $4.7 million. We are amortizing the intellectual property assets
acquired over six years starting in April 2007.
Other Income (Expense): Other income (expense) includes interest income, interest expense, warrant
benefit, foreign currency exchange gains and losses and other non-operating costs when incurred.
Other income was $65,000 and $372,000 for the three months ended June 30, 2007 and 2006,
respectively, with $328,000 of the change resulting from no warrant benefit in the three months
ended June 30, 2007
In May 2002, we conducted a public rights offering. In the rights offering, we issued to those
shareholders who exercised their rights three shares of our common stock and a warrant, exercisable
through July 2004, to purchase an additional share of our common stock. We registered with the SEC
the issuance of the shares, the warrants and the shares underlying the warrants. In July 2004, we
suspended the right to exercise the warrants shortly before their scheduled expiration date because
we announced a planned restatement of our fiscal 2004 financial statements. In November 2004, we
became current with our SEC filings. In April 2005, we chose to issue like-kind replacement
warrants to the holders of the expired warrants. The terms for the replacement warrants required
that we issue shares covered by a registration statement and maintain the effectiveness of the
registration (by making timely SEC filings) for the warrant holders to receive registered shares
upon exercise of the warrants. In April 2005, we recognized a liability and equity charge of $1.4
million associated with the grant of these warrants, and subsequently recognized in other income
(expense) the change in fair value of the warrants due to the change in the value of our common
stock issuable upon exercise of these warrants. We determined the fair value of the warrants using
the Black-Scholes option-pricing model. The period to exercise the warrants ended in March 2007.
We recognized a net warrant benefit of $328,000 in the first quarter of fiscal 2007.
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 $(2,000) and $26,000 for the three months ended June 30, 2007 and 2006,
respectively.
Income Tax Expense: During the three months ended June 30, 2007 and 2006, our Dutch subsidiaries
recorded income tax expense of $95,856 and $30,751, respectively. During the three months ended
June 30, 2007 and 2006, our U.S. organization recorded income tax expense of $300 and $0,
respectively. We cannot use our U.S. net operating loss carry forwards to offset taxable income
in foreign jurisdictions. Effective January 1, 2007, the maximum Dutch income tax rate is 25.5%
for taxable income in excess of 60,000.
Non-GAAP Financial Measures. In addition to disclosing the financial results for the three months
ended June 30, 2007 and 2006, calculated in accordance with U.S. generally accepted accounting
principles (GAAP), our discussion of the results of operations above contains non-GAAP
Page 18
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 June 30, 2007, our cash and cash equivalents balances totaled $3.2 million and our short-term
investments totaled $2.4 million.
At June 30, 2007, we had working capital of approximately $7.1 million. For the three months ended
June 30, 2007, we used $1.6 million of cash in operating activities, compared to $1.4 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 receivables due to our sales growth and to other
investments in working capital.
Sources of Liquidity.
In August 2006, we entered into a securities purchase agreement with certain investors
pursuant to which we sold approximately 1.4 million shares of our common stock for $1.50 per share,
together with warrants to purchase 695,000 shares of our common stock, for an aggregate purchase
price of approximately $2.1 million. After offset for our estimated costs of
$183,000, we received net proceeds of approximately $1.9 million. The warrants are exercisable for
five years (but commencing 181 days after closing) at an exercise price of $2.50 per share.
In December 2006, we conducted a follow-on public offering in which we sold 2,430,000 shares of our
common stock at a price per share of $2.00, resulting in net proceeds of approximately $4.3
million.
In May 2007, we amended our business loan agreement with Venture Bank. The agreement, expiring in
May 2008, provides for a credit line of up to $1 million secured by our assets. We may borrow up
to 50% (to a maximum of $500,000) of the value of our eligible inventory on hand in the U.S. and
80% of our eligible U.S. accounts receivable value. To borrow any amount, we must maintain
consolidated net equity of at least equal to $3.5 million as well as maintain certain other
financial covenants on a quarterly basis. The bank charges interest on the loan at a per annum
rate of the greater of 7.5% or one percentage point over the prime rate (8.25% on June 30, 2007).
In addition, Uroplasty BV, our subsidiary, entered into an agreement with Rabobank of The
Netherlands for a 500,000 (approximately $667,000) credit line. The bank charges interest on
the loan at the rate of one percentage point over the Rabobank base interest rate (5.25% on June
30, 2007), subject to a minimum interest rate of 3.5% per annum. At June 30, 2007, we had no
borrowings outstanding under any of our credit lines.
Because we have yet to achieve profitability and generate positive cash flows, we will need to
raise additional debt or equity financing to continue funding for product development, continued
expansion of our sales and marketing activities and planned growth activities beyond fiscal 2008.
There can be no guarantee that we will be successful, as we currently have no committed sources of,
or other arrangements with respect to, additional equity or debt financing.
We therefore cannot ensure that we will obtain additional financing on
acceptable terms, or at all. If we are unable to raise the needed funds, we will need to curtail
our operations including product development, clinical studies and sales and marketing activities.
This would adversely impact our future business and prospects. Ultimately, we will need to achieve
profitability and generate positive cash flows from operations to fund our operations and grow our
business.
Page 19
For the balance of fiscal 2008, we expect to incur additional research and development expenses,
including those in connection with clinical trials for the Urgent PC and FDA-required post-approval
studies to obtain market feedback on safety and effectiveness of Macroplastique. We also expect
that during the balance of fiscal 2008, we will continue to incur significant expenses as we fund
our selling and marketing organization in the U.S. to market our products.
We have an exclusive distribution agreement effective May 2005 (a one-year agreement with automatic
renewal for up to two years) with CL Medical, allowing us to market and sell the I-Stop urethral
sling in the United Kingdom. Under the agreement, we are required to purchase a minimum of
$350,000 of units in the first 12-month period following January 1, 2007, increasing to $674,000 of
units in the fourth year of the agreement, for an aggregate commitment of approximately $2 million
of units over the remaining agreement period, subject to periodic adjustment based on the value of
the euro.
Under a royalty agreement we pay royalties, in the aggregate, of three to five percent of net sales
of Macroplastique, Bioplastique, and PTQ Implants subject to a monthly minimum of $4,500. The
royalties payable under this agreement will continue until the patent referenced in the agreement
expires in 2010. Under a license agreement for the Macroplastique Implantation System, we pay a
royalty of 10 British pounds for each unit sold during the life of the patent.
We have a pension plan covering eight employees in The Netherlands, reported as a defined benefit
plan. We pay premiums to an insurance company to fund annuities for these employees. However, we
are responsible for funding additional annuities based on continued service and future salary
increases. We closed this defined benefit plan for new employees in April 2005. As of that date,
the Dutch subsidiary established a defined contribution plan that now covers new employees. We
also closed our UK subsidiarys defined benefit plan to further accrual for all employees effective
December 31, 2004, and, effective March 2005, established a defined contribution plan that now
covers new employees.
In January 2006, we entered into a long-term lease with Liberty Property Limited Partnership for an
18,258 square foot facility for our U.S. headquarters located at 5420 Feltl Road, Minnetonka,
Minnesota. The lease effective date was May 1, 2006, has a term of 96 months, requires average
annual minimum rent payments of approximately $140,000 and requires payments for operating expenses
we estimated at approximately $82,000 over 12 months.
Repayments of our contractual obligations as of June 30, 2007, consisting of royalties, notes
payable (inclusive of interest), and operating leases, are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Remainder |
|
|
Fiscal |
|
|
Fiscal |
|
|
Fiscal |
|
|
|
|
|
|
|
of Fiscal |
|
|
2009 and |
|
|
2011 and |
|
|
2013 and |
|
|
|
Total |
|
|
2008 |
|
|
2010 |
|
|
2012 |
|
|
thereafter |
|
Minimum royalty payments |
|
$ |
180,000 |
|
|
$ |
40,500 |
|
|
$ |
108,000 |
|
|
$ |
31,500 |
|
|
$ |
|
|
Minimum purchase agreement |
|
|
2,329,911 |
|
|
|
732,013 |
|
|
|
1,092,575 |
|
|
|
505,323 |
|
|
|
|
|
Notes payable, including
interest |
|
|
600,403 |
|
|
|
77,420 |
|
|
|
161,230 |
|
|
|
103,606 |
|
|
|
258,147 |
|
Operating lease commitments |
|
|
1,308,241 |
|
|
|
203,492 |
|
|
|
427,332 |
|
|
|
370,108 |
|
|
|
307,309 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
4,418,555 |
|
|
$ |
1,053,425 |
|
|
$ |
1,789,137 |
|
|
$ |
1,010,537 |
|
|
$ |
565,456 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITEM 3. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls Procedures. Within the 90 days prior to the date of this report,
our President and Chief Executive Officer and Chief Financial Officer carried out an evaluation of
the effectiveness of the design and operation of our disclosure controls and procedures pursuant to
Rule 13a-15b under the Securities Exchange Act of 1934. Based on this evaluation, these officers
concluded that, as of the end of the period covered by this report, our disclosure controls and
procedures are effective to ensure that information required to be disclosed by us in the reports
we file or submit under the Exchange Act is accumulated and communicated to our management,
including such officers, to allow timely decisions regarding disclosure, and is recorded,
processed, summarized and reported within the time periods specified in Securities and Exchange
Commission rules and forms.
Page 20
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 June 30, 2007, or thereafter, that have
materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
Any control system, no matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system are met. The design of a control
system inherently has limitations, and the benefits of
controls must be weighed against their costs. Additionally, controls can be circumvented by the
individual acts of some persons, by collusion of two or more people, or by management override of
the control. Therefore, no evaluation of a cost-effective system of controls can provide absolute
assurance that all control issues and instances of fraud, if any, will be detected.
Page 21
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 June 30, 2007.
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 6. EXHIBITS.
(a) Exhibits
31.1 Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
32.1 Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (this Exhibit is furnished pursuant to SEC rules,
but is deemed not filed)
Page 22
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: August 13, 2007
|
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By:
|
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/s/ DAVID B. KAYSEN
|
|
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|
|
David B. Kaysen
President and Chief Executive Officer |
|
|
|
|
|
|
|
|
|
Date: August 13, 2007
|
|
By:
|
|
/s/ MAHEDI A. JIWANI
|
|
|
|
|
Mahedi A. Jiwani
Chief Financial Officer |
|
|
Page 23