e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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Quarterly Report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the Quarterly Period Ended December 31, 2009
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o |
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Transition Report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the Transition Period from to .
Commission File No. 001-32632
UROPLASTY, INC.
(Exact name of registrant as specified in its Charter)
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Minnesota, U.S.A.
(State or other jurisdiction of
incorporation or organization)
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41-1719250
(I.R.S. Employer
Identification No.) |
5420 Feltl Road
Minnetonka, Minnesota, 55343
(Address of principal executive offices)
(952) 426-6140
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. YES þ NO o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S. YES o NO o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
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Large Accelerated Filer o
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Accelerated Filer o
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Non-Accelerated Filer o
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Smaller Reporting Company þ |
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(Do not check if a smaller reporting company)
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act)
YES o NO þ
As of January 31, 2010 the registrant had 14,946,540 shares of common stock outstanding.
Table of Contents
INDEX
UROPLASTY INC. AND SUBSIDIARIES
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3 |
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5 |
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6 |
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7 |
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15 |
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20 |
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20 |
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21 |
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21 |
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21 |
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21 |
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21 |
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21 |
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21 |
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22 |
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Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to Section 302 |
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23 |
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Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to Section 906 |
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25 |
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EX-31.1 |
EX-32.1 |
Page 2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
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December 31, 2009 |
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March 31, 2009 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
2,403,132 |
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$ |
3,276,299 |
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Short-term investments |
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3,500,000 |
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4,500,000 |
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Accounts receivable, net |
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1,204,466 |
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1,214,049 |
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Inventories |
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416,632 |
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495,751 |
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Other |
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266,901 |
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279,898 |
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Total current assets |
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7,791,131 |
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9,765,997 |
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Property, plant, and equipment, net |
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1,311,307 |
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1,401,229 |
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Intangible assets, net |
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2,744,143 |
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3,378,648 |
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Prepaid pension asset |
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93,040 |
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66,130 |
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Deferred tax assets |
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79,946 |
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68,793 |
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Total assets |
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$ |
12,019,567 |
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$ |
14,680,797 |
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See accompanying notes to the condensed consolidated financial statements.
Page 3
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
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December 31, 2009 |
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March 31, 2009 |
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(unaudited) |
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Liabilities and Shareholders Equity |
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Current liabilities: |
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Current portion deferred rent |
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$ |
35,000 |
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$ |
35,000 |
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Accounts payable |
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292,087 |
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604,593 |
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Income tax payable |
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56,785 |
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Accrued liabilities: |
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Compensation |
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888,083 |
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983,052 |
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Other |
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181,611 |
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248,568 |
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Total current liabilities |
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1,396,781 |
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1,927,998 |
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Deferred rent less current portion |
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121,307 |
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147,576 |
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Accrued pension liability |
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321,471 |
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296,646 |
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Total liabilities |
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1,839,559 |
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2,372,220 |
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Commitments and Contingencies |
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Shareholders equity: |
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Common stock $.01 par value;
40,000,000
shares authorized, 14,946,540
shares issued and outstanding
at December 31 and March 31,
2009 |
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149,465 |
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149,465 |
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Additional paid-in capital |
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36,120,202 |
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35,763,619 |
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Accumulated deficit |
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(26,040,519 |
) |
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(23,413,350 |
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Accumulated other comprehensive
loss |
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(49,140 |
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(191,157 |
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Total shareholders equity |
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10,180,008 |
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12,308,577 |
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Total liabilities and shareholders equity |
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$ |
12,019,567 |
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$ |
14,680,797 |
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See accompanying notes to the condensed consolidated financial statements.
Page 4
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended |
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Nine Months Ended |
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December 31, |
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December 31, |
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2009 |
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2008 |
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2009 |
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2008 |
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Net sales |
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$ |
3,068,142 |
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$ |
3,387,285 |
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$ |
8,880,546 |
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$ |
11,833,422 |
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Cost of goods sold |
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505,399 |
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533,987 |
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1,592,443 |
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1,791,153 |
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Gross profit |
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2,562,743 |
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2,853,298 |
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7,288,103 |
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10,042,269 |
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Operating expenses |
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General and administrative |
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639,608 |
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713,545 |
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2,201,199 |
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2,670,653 |
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Research and development |
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401,481 |
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723,673 |
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1,365,194 |
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1,457,170 |
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Selling and marketing |
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1,702,900 |
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2,125,274 |
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5,728,242 |
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7,250,906 |
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Amortization |
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211,189 |
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211,626 |
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634,505 |
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633,567 |
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2,955,178 |
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3,774,118 |
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9,929,140 |
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12,012,296 |
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Operating loss |
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(392,435 |
) |
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(920,820 |
) |
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(2,641,037 |
) |
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(1,970,027 |
) |
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Other income (expense) |
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Interest income |
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21,468 |
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24,001 |
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77,097 |
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162,657 |
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Interest expense |
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(1,291 |
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(1,787 |
) |
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(10,986 |
) |
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(15,372 |
) |
Foreign currency exchange loss |
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(8,335 |
) |
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(23,030 |
) |
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(731 |
) |
Other, net |
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(183 |
) |
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(4,687 |
) |
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11,842 |
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22,214 |
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42,898 |
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141,867 |
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Loss before income taxes |
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(380,593 |
) |
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(898,606 |
) |
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(2,598,139 |
) |
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(1,828,160 |
) |
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Income tax expense (benefit) |
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6,143 |
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(4,684 |
) |
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|
29,030 |
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33,374 |
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Net loss |
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$ |
(386,736 |
) |
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$ |
(893,922 |
) |
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$ |
(2,627,169 |
) |
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$ |
(1,861,534 |
) |
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Basic and diluted loss per common share |
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$ |
(0.03 |
) |
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$ |
(0.06 |
) |
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$ |
(0.18 |
) |
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$ |
(0.12 |
) |
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Weighted average common shares
outstanding: |
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Basic and diluted |
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14,946,540 |
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14,924,540 |
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14,943,638 |
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14,919,216 |
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See accompanying notes to the condensed consolidated financial statements.
Page 5
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS EQUITY AND COMPREHENSIVE LOSS
Nine months ended December 31, 2009
(Unaudited)
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Additional |
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Accumulated |
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Total |
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Common Stock |
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Paid-in |
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Accumulated |
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Other 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 |
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Income (loss) |
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Equity |
Balance at March
31, 2009 |
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14,946,540 |
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$ |
149,465 |
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$ |
35,763,619 |
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$ |
(23,413,350 |
) |
|
$ |
(191,157 |
) |
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$ |
12,308,577 |
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Share-based
compensation |
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356,583 |
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356,583 |
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Comprehensive loss |
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(2,627,169 |
) |
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|
142,017 |
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|
(2,485,152 |
) |
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Balance at December
31, 2009 |
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14,946,540 |
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|
$ |
149,465 |
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$ |
36,120,202 |
|
|
$ |
(26,040,519 |
) |
|
$ |
(49,140 |
) |
|
$ |
10,180,008 |
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See accompanying notes to the condensed consolidated financial statements.
Page 6
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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Nine Months Ended |
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December 31, |
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2009 |
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|
2008 |
|
Cash flows from operating activities: |
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|
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|
Net loss |
|
$ |
(2,627,169 |
) |
|
$ |
(1,861,534 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
|
|
852,370 |
|
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|
849,933 |
|
Loss on disposal of equipment |
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|
183 |
|
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|
4,687 |
|
Share-based consulting expense |
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|
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|
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|
52,567 |
|
Share-based compensation expense |
|
|
356,583 |
|
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|
583,013 |
|
Deferred income taxes |
|
|
(5,299 |
) |
|
|
(11,531 |
) |
Deferred rent |
|
|
(26,250 |
) |
|
|
(26,250 |
) |
Changes in operating assets and liabilities: |
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|
|
|
|
|
|
Accounts receivable |
|
|
71,404 |
|
|
|
668,510 |
|
Inventories |
|
|
112,460 |
|
|
|
(34,427 |
) |
Other current assets and income tax receivable |
|
|
(44,238 |
) |
|
|
8,173 |
|
Accounts payable |
|
|
(324,094 |
) |
|
|
(91,686 |
) |
Accrued liabilities |
|
|
(221,266 |
) |
|
|
(802,027 |
) |
Accrued pension liability, net and income tax payable |
|
|
(20,141 |
) |
|
|
(7,585 |
) |
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(1,875,457 |
) |
|
|
(668,157 |
) |
|
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|
Cash flows from investing activities: |
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|
|
|
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|
Proceeds from sale of short-term investments |
|
|
3,000,000 |
|
|
|
14,157,410 |
|
Purchase of short-term investments |
|
|
(2,000,000 |
) |
|
|
(7,891,373 |
) |
Purchases of property, plant and equipment |
|
|
(70,354 |
) |
|
|
(181,354 |
) |
Proceeds from sale of property, plant and equipment |
|
|
2,000 |
|
|
|
|
|
Payments for intangible assets |
|
|
|
|
|
|
(23,282 |
) |
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
931,646 |
|
|
|
6,061,401 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Repayment of debt obligations |
|
|
|
|
|
|
(455,913 |
) |
|
|
|
|
|
|
|
Net cash used in financing activities |
|
|
|
|
|
|
(455,913 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
70,644 |
|
|
|
(255,095 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
(873,167 |
) |
|
|
4,682,236 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
3,276,299 |
|
|
|
3,880,044 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
2,403,132 |
|
|
$ |
8,562,280 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
6,145 |
|
|
$ |
13,612 |
|
Cash paid during the period for income taxes |
|
|
121,655 |
|
|
|
53,739 |
|
See accompanying notes to the condensed consolidated financial statements.
Page 7
UROPLASTY, INC. AND SUBSIDIARIES
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. Basis of Presentation
We have prepared our condensed consolidated financial statements included in this Form 10-Q,
without audit, pursuant to the rules and regulations of the Securities and Exchange Commission.
Certain information and footnote disclosures normally included in the consolidated financial
statements prepared in accordance with accounting principles generally accepted in the United
States of America have been condensed or omitted, pursuant to such rules and regulations, although
we believe that our disclosures are adequate to make the information not misleading. The
consolidated results of operations for any interim period are not necessarily indicative of results
for a full year. These condensed consolidated financial statements should be read in conjunction
with the audited consolidated financial statements and related notes included in our Annual Report
on Form 10-K for the year ended March 31, 2009.
The condensed consolidated financial statements presented herein as of December 31, 2009 and for
the three- and nine-month periods ended December 31, 2009 and 2008 reflect, in the opinion of
management, all material adjustments, consisting only of normal recurring adjustments, necessary
for a fair presentation of the consolidated financial position, results of operations and cash
flows for the interim periods.
We have identified certain accounting policies that we consider particularly important for the
portrayal of our results of operations and financial position and which may require the application
of a higher level of judgment by our management, and as a result are subject to an inherent level
of uncertainty. These are characterized as critical accounting policies and address revenue
recognition, accounts receivable, inventories, foreign currency translation and transactions,
impairment of long-lived assets, share-based compensation, defined benefit pension plans and income
taxes, each of which is described in our Annual Report on Form 10-K for the year ended March 31,
2009. Based upon our review, we have determined that these policies remain our most critical
accounting policies for the three- and nine-month periods ended December 31, 2009, and we have made
no changes to these policies during fiscal 2010.
2. Short-term Investments
Short-term investments consist of certificates of deposit held-to-maturity that mature within the
next twelve months. Based on the short-term nature of these investments, their cost approximates
their fair market value. We have determined that short-term investments and cash and cash
equivalents are Level 1 inputs within the fair value hierarchy of Accounting Standards Codification
(ASC 820), Fair Value Measurements and Disclosures.
3. Accounts Receivable
We grant credit to our customers in the normal course of business and, generally, do not require
collateral or any other security to support amounts due. If necessary, we have an outside party
assist us with performing credit and reference checks and establishing credit limits for the
customer. Accounts outstanding longer than the contractual payment terms, are considered past due.
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 by considering a number of factors, including the length of time accounts
receivables are past due, customer financial condition and ability to pay the obligation,
historical and expected credit loss experience, and the condition of the general economy and the
industry as a whole. We write off accounts receivable when deemed uncollectible. We record
recoveries of accounts receivable previously written off when received. We are not always able to
timely anticipate changes in the financial condition of our customers and if circumstances related
to these customers deteriorate, our estimates of the recoverability of accounts receivable could be
materially affected and we may be required to record additional allowances. Alternatively, if more
allowances are provided than are ultimately required, we may reverse a portion of such provisions
in future periods based on the actual collection experience. Historically, the accounts receivable
balances we have written off have generally been within our expectations. The allowance for
doubtful accounts was $18,000 and $114,000 at December 31, 2009 and March 31, 2009, respectively.
Page 8
4. Inventories
Inventories are stated at the lower of cost (first-in, first-out method) or market (net realizable
value). Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009 |
|
|
March 31, 2009 |
|
Raw materials |
|
$ |
167,423 |
|
|
$ |
227,054 |
|
Work-in-process |
|
|
37,633 |
|
|
|
23,326 |
|
Finished goods |
|
|
211,576 |
|
|
|
245,371 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
416,632 |
|
|
$ |
495,751 |
|
|
|
|
|
|
|
|
5. Intangible Assets
Intangible Assets. Our intangible assets are comprised of patents and licensed technology which
we amortize on a straight-line basis over their estimated useful lives or contractual terms,
whichever is less.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
|
|
Estimated |
|
|
Carrying |
|
|
Accumulated |
|
|
|
|
|
|
Lives (Years) |
|
|
Amount |
|
|
Amortization |
|
|
Net value |
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
Patents and licensed technology |
|
|
6 |
|
|
$ |
5,472,512 |
|
|
$ |
2,728,369 |
|
|
$ |
2,744,143 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
Patents and licensed technology |
|
|
6 |
|
|
$ |
5,472,512 |
|
|
$ |
2,093,864 |
|
|
$ |
3,378,648 |
|
Estimated annual amortization for these assets for the years ending March 31, is as follows:
|
|
|
|
|
Remainder of 2010 |
|
$ |
211,000 |
|
2011 |
|
|
843,000 |
|
2012 |
|
|
842,000 |
|
2013 |
|
|
842,000 |
|
2014 |
|
|
4,000 |
|
2015 and beyond |
|
|
2,000 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,744,000 |
|
|
|
|
|
6. Deferred Rent and Leasehold Improvements
We entered into an 8-year operating lease agreement, effective May 2006, for our corporate facility
in Minnesota. As part of the agreement, the landlord provided an incentive of $280,000 for
leasehold improvements. We recorded this incentive as deferred rent and are amortizing it as a
reduction in lease expense over the lease term in accordance to ASC 840, Leases. We are
amortizing the leasehold improvements over the shorter of the asset life or the lease term.
Page 9
7. Comprehensive Loss
Comprehensive loss includes our net loss, accumulated translation adjustment, and change in minimum
pension obligation as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Net loss |
|
$ |
(386,736 |
) |
|
$ |
(893,922 |
) |
|
$ |
(2,627,169 |
) |
|
$ |
(1,861,534 |
) |
Items of other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated translation adjustment |
|
|
(30,808 |
) |
|
|
(115,013 |
) |
|
|
145,259 |
|
|
|
(432,881 |
) |
Minimum pension obligation |
|
|
1,475 |
|
|
|
4,094 |
|
|
|
(3,242 |
) |
|
|
15,889 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(416,069 |
) |
|
$ |
(1,004,841 |
) |
|
$ |
(2,485,152 |
) |
|
$ |
(2,278,526 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other accumulated comprehensive income (loss) at December 31, 2009 totalled $(49,140) and consists
of $2,870 for accumulated translation adjustment and $(52,010) for accumulated additional pension
liability.
8. Net Loss per Common Share
The following restricted stock, options and warrants outstanding at December 31, 2009 and 2008, to
purchase shares of common stock, were excluded from diluted loss per common share because of their
anti-dilutive effect:
|
|
|
|
|
|
|
|
|
|
|
Number of Restricted |
|
|
Range of |
|
|
|
Stock/Options/Warrants |
|
|
Exercise Prices |
|
December 31, 2009 |
|
|
4,141,928 |
|
|
$ |
0.71 to $5.19 |
|
December 31, 2008 |
|
|
4,282,028 |
|
|
$ |
1.82 to $5.30 |
|
9. Credit Facilities
Uroplasty BV, our subsidiary, has an agreement with Rabobank of The Netherlands for a 500,000
(approximately $717,000) credit line. The bank charges interest on the loan at the rate of one
percentage point over the Rabobank base interest rate (4.85% base rate on December 31, 2009),
subject to a minimum interest rate of 3.5% per annum. At December 31, 2009, we had no borrowings
outstanding on this credit line.
On October 30, 2009 we entered into a one-year business loan agreement with Venture Bank. The
agreement provides for a credit line of up to $2 million secured by the assets of our company. We
may borrow up to 50% (to a maximum of $500,000) of the value of our eligible inventory on hand and
80% of the value of our eligible U.S. accounts receivable; provided, however, our total
liabilities, inclusive of the amount borrowed, may not exceed our tangible net worth. To be
eligible to borrow any amount, we must maintain a minimum tangible net worth of $5 million. At
December 31, 2009 we had no borrowings outstanding under this agreement, but we estimate we had a
borrowing capacity of approximately $0.5 million. Interest on the outstanding borrowings is charged
at a per annum rate of the greater of 7.5% or one percentage point over the prime rate (3.25% prime
rate on December 31, 2009).
10. Warrants
As of December 31, 2009, we had issued and outstanding warrants to purchase an aggregate of
2,066,928 common shares, at a weighted average exercise price of $3.78.
In connection with the equity offerings of April 2005 private placement, August 2006 private
placement and December 2006 follow-on offering, we issued five-year warrants to purchase 1,180,928,
764,500, 121,500 common shares, respectively, at exercise prices of $4.75, $2.50 and $2.40 per
share, respectively.
Page 10
11. Share-based Compensation
As of December 31, 2009, we had one active plan (2006 Amended Stock and Incentive Plan) for
share-based compensation grants. Under the plan, if we have a change in control, all outstanding
grants, including those subject to vesting or other performance targets, fully vest immediately.
Under this plan, we had reserved 2,700,000 shares of our common stock for share-based grants. As
of December 31, 2009, we had remaining 1,500,000 shares available for grant. We 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 ASC 718, Compensation Stock Compensation.
We incurred a total of approximately $357,000 and $636,000 in share-based compensation expense
(inclusive of $0 and $53,000, respectively, for option grants to consultants) for the nine months
ended December 31, 2009 and 2008, respectively.
We determined the fair value of our option awards using the Black-Scholes option pricing model. We
used the following weighted-average assumptions to value the options granted during the following
periods:
|
|
|
|
|
|
|
|
|
|
|
Nine months Ended |
|
|
Nine months Ended |
|
|
|
December 31, 2009 |
|
|
December 31, 2008 |
|
|
|
|
Expected life in years |
|
|
4.83 |
|
|
|
4.06 |
|
Risk-free interest rate |
|
|
2.74 |
% |
|
|
3.13 |
% |
Expected volatility |
|
|
94.21 |
% |
|
|
82.70 |
% |
Expected dividend yield |
|
|
0 |
|
|
|
0 |
|
Weighted-average fair value |
|
$ |
0.60 |
|
|
$ |
1.88 |
|
The expected life selected for options granted during the quarter represents the period of time
that we expect our options to be outstanding based on historical data of option holder exercise and
termination behavior for similar grants. The risk-free interest rate for periods within the
contractual life of the option is based on the U.S. Treasury rate over the expected life at the
time of grant. Expected volatilities are based upon historical volatility of our stock. We
estimate a forfeiture rate for stock awards of up to 14.5% based on our historical experience.
The following table summarizes the activity related to our stock options during the nine months
ended December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
average |
|
|
Aggregate |
|
|
|
Number of |
|
|
average |
|
|
remaining life |
|
|
intrinsic |
|
|
|
shares |
|
|
exercise price |
|
|
in years |
|
|
value |
|
|
|
|
Options outstanding at March 31, 2009 |
|
|
2,134,500 |
|
|
$ |
3.93 |
|
|
|
4.02 |
|
|
$ |
|
|
Options granted |
|
|
380,000 |
|
|
|
0.83 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options expired and cancelled |
|
|
(439,500 |
) |
|
|
4.97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at December 31, 2009 |
|
|
2,075,000 |
|
|
$ |
3.14 |
|
|
|
4.16 |
|
|
$ |
251,725 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2009 |
|
|
1,777,662 |
|
|
$ |
3.41 |
|
|
|
4.16 |
|
|
$ |
120,407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value for the outstanding options as of March 31, 2009 was zero because all
the grants were out-of-the-money based on the closing price of our Companys common stock on March
31, 2009. As of December 31, 2009, we had approximately $156,000 of unrecognized share-based
compensation expense, net of estimated forfeitures, related to options that we expect to recognize
over a weighted-average period of 1.22 years.
Page 11
The following table summarizes the activity related to our restricted shares during the nine months
ended December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted average |
|
|
Aggregate |
|
|
|
Number of |
|
|
average grant |
|
|
remaining life in |
|
|
intrinsic |
|
|
|
Shares |
|
|
date fair value |
|
|
years |
|
|
value |
|
|
|
|
Balance at March 31, 2009 |
|
|
14,000 |
|
|
$ |
3.15 |
|
|
|
0.16 |
|
|
$ |
44,100 |
|
Shares granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares vested |
|
|
14,000 |
|
|
|
3.15 |
|
|
|
|
|
|
|
|
|
Shares cancelled |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value represents the total pre-tax value of restricted stock that holders
would have received (based on the closing price of our Companys common stock on the grant date)
had all restricted stock vested and if we had issued common stock to the holders on the grant date.
As of December 31, 2009, all of the restricted shares have fully vested and we had no unrecognized
compensation expense related to restricted stock.
12. 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 contributions to
the U.S. plan of $105,000 and $0 for the nine months ended December 31, 2009 and 2008,
respectively.
Our international subsidiaries have defined benefit retirement plans for eligible employees. These
plans provide benefits based on the employees years of service and compensation during the years
immediately preceding retirement, termination, disability, or death, as defined in the plans. We
froze the UK subsidiarys defined benefit plan on December 31, 2004. On March 10, 2005, we
established a defined contribution plan for the UK subsidiary. As of April 1, 2005 we closed The
Netherlands subsidiarys defined benefit retirement plan for new employees and established for them
a defined contribution plan.
The cost for our defined benefit retirement plans in The Netherlands and the United Kingdom
includes the following components for the three and nine-month periods ended December 31, 2009 and
2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Gross service cost |
|
$ |
16,692 |
|
|
$ |
15,276 |
|
|
$ |
48,278 |
|
|
$ |
50,933 |
|
Interest cost |
|
|
24,152 |
|
|
|
21,350 |
|
|
|
70,205 |
|
|
|
71,868 |
|
Expected return on assets |
|
|
1,579 |
|
|
|
3,934 |
|
|
|
4,188 |
|
|
|
12,454 |
|
Amortization |
|
|
(117 |
) |
|
|
914 |
|
|
|
(337 |
) |
|
|
3,041 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic retirement cost |
|
$ |
42,306 |
|
|
$ |
41,474 |
|
|
$ |
122,334 |
|
|
$ |
138,296 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Major assumptions used in the above calculations include:
|
|
|
|
|
|
|
|
|
|
|
Nine months Ended |
|
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Discount rate |
|
|
6.60-6.70 |
% |
|
|
6.10-6.70 |
% |
Expected return on assets |
|
|
5.00-6.60 |
% |
|
|
5.00-6.10 |
% |
Expected rate of increase in future
compensation: |
|
|
|
|
|
|
|
|
General |
|
|
3 |
% |
|
|
3 |
% |
Individual |
|
|
0-3 |
% |
|
|
0-3 |
% |
Page 12
The United Kingdom pension plan is in an over funded position and its funded status is shown
as a prepaid pension asset. The Netherlands pension plan is in an under funded position and its
funded status is shown as accrued pension liability.
We made aggregate contributions of approximately $154,000 and $151,000, respectively, during the
nine months ended December 31, 2009 and 2008 to the two defined benefit plans. We made aggregate
contributions of approximately $12,000 and $31,000 , respectively, during the nine months ended
December 31, 2009 and 2008 to the two defined contribution plans.
13. Foreign Currency Translation
We translate all assets and liabilities using period-end exchange rates. We translate statements
of operations items using average exchange rates for the period. We record the resulting
translation adjustment within accumulated other comprehensive loss, a separate component of
shareholders equity. We recognize foreign currency transaction gains and losses in our
consolidated statements of operations, including unrealized gains and losses on short-term
intercompany obligations using period-end exchange rates. We recognize unrealized gains and losses
on long-term intercompany obligations within accumulated other comprehensive loss, a separate
component of shareholders equity.
We recognize exchange gains and losses primarily as a result of fluctuations in currency rates
between the U.S. dollar (the functional reporting currency) and the Euro and British pound
(currencies of our subsidiaries), as well as their effect on the dollar denominated intercompany
obligations between us and our foreign subsidiaries. All intercompany balances are revolving in
nature and we do not deem them to be long-term balances. For the three months ended December 31,
2009 and 2008, we recognized foreign currency exchange loss of $8,335 and $0, respectively. For
the nine months ended December 31, 2009 and 2008, we recognized foreign currency exchange loss of
$23,030 and $731, respectively.
14. Business Segment Information
ASC 280, Segment Reporting, establishes disclosure standards for segments of a company based on
managements approach to defining operating segments. In accordance with the objective and basic
principles of the standard we aggregate our operating segments into one reportable segment.
Information regarding our geographic operations for the three- and nine-month periods ended
December 31, 2009 and 2008 is as follows:
|
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|
|
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|
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|
|
United |
|
|
The |
|
|
United |
|
|
|
|
|
|
States |
|
|
Netherlands |
|
|
Kingdom |
|
|
Consolidated |
|
Three months ended December 31, 2009 |
|
|
|
|
|
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|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales to customers |
|
$ |
1,514,489 |
|
|
$ |
1,180,952 |
|
|
$ |
372,701 |
|
|
$ |
3,068,142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended December 31, 2009 |
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales to customers |
|
$ |
4,477,944 |
|
|
$ |
3,246,190 |
|
|
$ |
1,156,412 |
|
|
$ |
8,880,546 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets at December 31, 2009 |
|
|
3,313,103 |
|
|
|
738,669 |
|
|
|
96,718 |
|
|
|
4,148,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales to customers |
|
$ |
1,945,508 |
|
|
$ |
1,010,201 |
|
|
$ |
431,576 |
|
|
$ |
3,387,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales to customers |
|
$ |
6,377,191 |
|
|
$ |
3,915,638 |
|
|
$ |
1,540,593 |
|
|
$ |
11,833,422 |
|
Accounting policies of the operations in the various geographic areas are the same as those
described in Note 1. Sales attributed to each geographic area are net of intercompany sales. No
single customer represents 10% or more of our consolidated net sales. Long-lived assets consist of
property and equipment, intangible assets and certain other assets.
Page 13
15. Income Tax Expense
As of March 31, 2009, we have generated approximately $23 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
During the three months ended December 31, 2009 and 2008, we recorded income tax expense (benefit)
of approximately $6,000 and $(5,000), respectively. During the nine months ended December 31, 2009
and 2008, we recorded income tax expense of approximately $29,000 and $33,000, respectively.
On December 31, 2009 and 2008 we had a deferred tax asset of $80,000 and $69,000, respectively. 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.
Effective April 1, 2007, we adopted ASC 740, Income Taxes, which prescribes a recognition
threshold and a measurement attribute for financial statement recognition of tax positions we take
or expect to take in a tax return. It is managements responsibility to determine whether it is
more-likely-than-not that a taxing authority will sustain a tax position upon examination,
including resolution of any related appeals or litigation processes, based on the technical merits
of the position. At adoption on April 1, 2007, we had no unrecognized tax benefits which needed
adjustment. We reviewed all income tax positions taken or that we expect to take for all open tax
years and determined that our income tax positions are appropriately stated and supported for all
open years. Accordingly, adoption of ASC 740 did not have a significant effect on our consolidated
financial statements.
Under our accounting policies we would recognize interest and penalties accrued on unrecognized tax
benefits as well as interest received from favorable tax settlements within income tax expense. At
the adoption date of April 1, 2007, we recognized no interest or penalties related to uncertain tax
positions. As of December 31, 2009, we recorded no accrued interest or penalties related to
uncertain tax positions.
The fiscal tax years 2005 through 2008 remain open to examination by the Internal Revenue Service
and various state taxing jurisdictions to which we are subject. In addition, we are subject to
examination by certain foreign taxing authorities for which the fiscal years 2007 through 2009
remain open for examination.
16. Recently Issued Accounting Standards
In August 2009, the FASB issued Accounting Standards Update No. 2009-05, Measuring
Liabilities at Fair Value (ASU 2009-05). This Standards Update provides amendments to ASC Topic
820, Fair Value Measurements and Disclosure for the fair value measurement of liabilities when a
quoted price in an active market is not available. This ASU was effective for our third quarter of
our fiscal 2010 and the adoption did not have an impact on our financial position or results of
operations.
In June 2009, the FASB issued SFAS No. 168, The FASB Accounting Codification and the Hierarchy of
Generally Accepted Accounting Principles. SFAS 168 replaced FASB Statement No. 162, The
Hierarchy of Generally Accepted Accounting Principles, and establishes the FASB Accounting
Standards Codification TM (Codification) as the source of authoritative
accounting principles recognized by the FASB to be applied by nongovernmental entities in the
preparation of financial statements in conformity with generally accepted accounting principles
(GAAP). SFAS 168 was effective for interim and annual periods ending after September 15, 2009. We
now use the new Codification when referring to GAAP in our interim financial statements. The
adoption of the SFAS 168 changes our references to U.S. GAAP, but does not have an impact on our
financial position or results of operations.
In May 2009, the FASB issued ASC 855, Subsequent Events. This Statement incorporates guidance
into accounting literature that was previously addressed only in auditing standards. The statement
refers to subsequent events that provide
Page 14
additional evidence about conditions that existed at the balance-sheet date as recognized subsequent events. Subsequent events which provide evidence
about conditions that arose after the balance sheet date but prior to the issuance of the financial
statements are referred to as non-recognized subsequent events. It also requires companies to
disclose the date through which subsequent events have been evaluated and whether this date is the
date the financial statements were issued or the date the financial statements were available to be
issued. We adopted this standard effective April 1, 2009 see Note 17.
In December 2008, the FASB issued additional guidance on an employers disclosures about plan
assets of a defined benefit pension or other postretirement plan. The requirements, effective for
fiscal years beginning after December 15, 2009, pertain only to the disclosures and do not affect
the accounting for defined benefit pensions or other postretirement plans. We do not anticipate
adoption of the new guidance to have an impact on our financial position or results of operations.
17. Subsequent events
We evaluated all subsequent events through February 1, 2010, the filing date of this Form 10-Q with
the Securities and Exchange Commission, to ensure that this Form 10-Q includes appropriate
disclosure of events both recognized in the financial statements as of December 31, 2009, and
events which occurred subsequent to December 31, 2009 but were not recognized in the financial
statements. As of February 1, 2010, we had no subsequent events which required recognition in the
financial statements.
|
|
|
ITEM 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
We recommend that you read this Report on Form 10-Q in conjunction with our Annual Report on Form
10-K for the year ended March 31, 2009.
Forward-looking Statements
This Form 10-Q contains forward-looking statements relating to projections, plans, objectives,
estimates, and other statements of future economic performance. These forward-looking statements
are subject to known and unknown risks and uncertainties relating to our future performance that
may cause our actual results, performance, or achievements, or industry results, to differ
materially from those expressed or implied in any such forward-looking statements. Our business
operates in highly competitive markets and is subject to changes in general economic conditions,
competition, reimbursement levels, customer and market preferences, government regulation, the
impact of tax regulation, foreign exchange rate fluctuations, the degree of market acceptance of
products, the uncertainties of potential litigation, as well as other risks and uncertainties
detailed elsewhere herein and in our Annual Report filed on Form 10-K for the year ended March 31,
2009.
We do not undertake, nor assume obligation, to update any forward-looking statement that we may
make from time to time.
Critical Accounting Policies
We prepare our consolidated financial statements in accordance with U.S. generally accepted
accounting principles, which require us to make estimates and assumptions in certain circumstances
that affect amounts reported. In preparing these consolidated financial statements, we have made
our best estimates and judgments of certain amounts, giving due consideration to materiality.
We have identified certain accounting policies that we consider particularly important for the
portrayal of our results of operations and financial position and which may require the application
of a higher level of judgment by our management, and as a result are subject to an inherent level
of uncertainty. These are characterized as critical accounting policies and address revenue
recognition, accounts receivable, inventories, foreign currency translation and transactions,
impairment of long-lived assets, share-based compensation, defined benefit pension plans and income
taxes, each of which is described in our Annual Report on Form 10-K for the year ended March 31,
2009. Based upon our review, we have determined that these policies remain our most critical
accounting policies for the nine-month period ended December 31, 2009, and we have made no changes
to these policies during fiscal 2010.
Page 15
Overview
We are a medical device company that develops, manufactures and markets innovative,
proprietary products for the treatment of voiding dysfunctions. Our primary focus is on two
products: our Urgent PC® system, which we believe is the only FDA-approved minimally
invasive, office-based neuromodulation therapy for the treatment of urinary urgency, urinary
frequency, and urge incontinence symptoms often associated with overactive bladder (OAB); and
Macroplastique®, a urethral bulking agent for the treatment of adult female stress
urinary incontinence primarily due to intrinsic sphincter deficiency (ISD). We believe physicians
prefer our products because they offer an effective therapy for the patient, can be administered in
office-based settings and, to the extent reimbursement is in place, provide the physicians a new
recurring revenue stream. We believe patients prefer our products because they are minimally
invasive treatment alternatives that do not have the side effects associated with pharmaceutical
treatment options nor the morbidity associated with surgery.
Outside of the U.S., our Urgent PC is also approved for treatment of fecal incontinence, and
Macroplastique is also approved for treatment of male stress incontinence and vesicoureteral
reflux.
Our sales performance has been greatly influenced by the sales in the U.S. of our Urgent PC system.
Starting in the second half of fiscal 2009, sales over corresponding year-ago periods of our
Urgent PC system declined and continued to do so in the first half of fiscal 2010 because of
reimbursement-related issues, although sales have stabilized at around $900,000 to $1 million per
quarter in each of the last three quarters. The American Medical Association (AMA) advised the
medical community during our first fiscal quarter of 2009 that their previously recommended
listed Current Procedure Technology (CPT) code for reimbursement of Urgent PC treatments should
be replaced with an unlisted code. As a result, some third-party insurance carriers are now
denying reimbursement while certain other carriers are reassessing their coverage and reimbursement
policies for Urgent PC treatments. However, many other third party payers, under a published
positive coverage policy or on a case-by-case basis, continue to provide reimbursement for Urgent
PC treatments.
A major part of our strategy, supported by publication of clinical studies in peer-reviewed
journals in the U.S., is to obtain a listed CPT code for percutaneous tibial nerve stimulation, and
expand third-party reimbursement coverage of Urgent PC treatments in the U.S. Additionally, we
continue to implement a comprehensive program designed to educate Medicare carriers and private
payer medical directors around the country about the benefits and clinical study results of Urgent
PC. The medical directors have asked for additional peer-reviewed publications in U.S. medical
journals and to date five new articles have been published. The most recent publication on the
results of the long-term phase of our earlier OrBIT clinical trial was published in the January
2010 issue of The Journal of Urology® and the results of our 12-week SUmiT
trial are expected to be published in the April 2010 issue of this journal.
We have submitted our application to the AMA, for consideration at their February 2010 meeting, for
a listed CPT code, which if granted would be effective in January 2011. We believe the
availability of a listed CPT code will encourage broader use of our Urgent PC. We expect that
Urgent PC sales will not return to prior historical sales levels in the U.S. until after a new
listed CPT code is assigned and payers create coverage policies that provide adequate
reimbursement.
Our results are also impacted by the steadily increasing sales in the U.S. of our Macroplastique
product because of our increased sales and marketing focus. Sales of our Macroplastique product in
the U.S., accounting for $1.5 million through nine months of our current fiscal year, have about
doubled over the corresponding year-ago quarter.
Our net loss for the nine months ended December 31, 2009 increased because of a decline in sales
and a decline in gross margin, primarily because of lower capacity utilization, offset partially by
a reduction in operating expenses. In the three months ended December 31, 2009, our net loss was
cut to less than one-half of the loss in the corresponding year-ago period because of a reduction
in spending.
Results of Operations
Three and nine months ended December 31, 2009 compared to three and nine months ended December 31,
2008
Net Sales: During the three months ended December 31, 2009, net sales of $3.1 million represented
a $319,000 or a 9% decrease, over net sales of $3.4 million for the three months ended
December 31, 2008. Excluding the translation impact of fluctuations in foreign currency exchange
rates, sales decreased by approximately 14%. During the nine months ended December 31, 2009, net
sales of $8.9 million represented a $2.9 million, or a 25% decrease, over net sales of $11.8
million for the nine months ended December 31, 2008. Excluding the translation impact of
fluctuations in foreign currency exchange rates, sales decreased by approximately 23%.
Sales to customers in the U.S. during the three months ended December 31, 2009 totaled $1.5
million, representing a $431,000, or a 22% decrease, over net sales of $1.9 million for the three
months ended December 31, 2008. During the nine
Page 16
months ended December 31, 2009 sales to customers in the U.S. totaled $4.5 million, representing a 30% decrease, over net sales of $6.4 million for
the nine months ended December 31, 2008.
Sales in the U.S. of our Urgent PC product, decreased 42% to $934,000 for three months ended
December 31, 2009, from $1.6 million for the same year-ago period, and for the nine months ended
December 31, 2009 decreased 48% to $2.9 million from $5.6 million for the same year-ago period.
The trend in decline of our Urgent PC sales over corresponding year-ago periods began in the second
half of fiscal 2009 due to reimbursement related issues. Sales have stabilized at around $900,000
to $1 million per quarter in each of the last three quarters.
Sales in the U.S. of our Macroplastique product, increased 76% to $565,000 for three months ended
December 31, 2009, from $321,000 for the same year-ago period, and for the nine months ended
December 31, 2009 increased 99% to $1.5 million from $762,000 for the same year-ago period. Sales
of our Macroplastique product have about doubled over the corresponding year-ago period because of
our increased sales and marketing focus.
Sales to customers outside the U.S. for the three months ended December 31, 2009 and 2008 were $1.6
million and $1.4 million, respectively, an increase of 8%. Excluding the translation impact of
fluctuations in foreign currency exchange rates, sales decreased by approximately 2%. For the nine
months ended December 31, 2009 and 2008 sales to customers outside of the U.S. were $4.4 million
and $5.5 million, respectively, a decrease of 19%. Excluding the translation impact of fluctuations
in foreign currency exchange rates, sales decreased by approximately 15%. We believe the sales
decrease for the nine months is mainly attributed to increased competition from a newly-introduced
product against our Macroplastique product. In addition, in fiscal year 2010 we discontinued in
the United Kingdom our I-Stop urethral sling product which accounted for approximately $135,000 in
sales for the nine months ended December 31, 2008 and $191,000 in sales in fiscal 2009.
Gross Profit: Gross profit was $2.6 million and $2.9 million for the three months ended December
31, 2009 and 2008, respectively, or 84% of net sales both periods. Gross profit was $7.3 million
and $10.0 million for the nine months ended December 31, 2009 and 2008, respectively, or 82% and
85% of net sales in the respective periods. We attribute the lower gross profit percentage in the
nine months ended December 31, 2009 primarily to a decrease in manufacturing capacity utilization
as a result of the decreased sales, changes in sales product mix, and the negative impact of
changes in the currency exchange rates from our foreign currency-denominated sales. The first two
factors each had an approximately one percentage point negative effect on the gross profit
percentage, and the last factor had a negative effect of about 0.5 percentage point on the gross
profit percentage.
General and Administrative Expenses (G&A): G&A expenses decreased $74,000 from $714,000 during
the three months ended December 31, 2008 to $640,000 during the same period in 2009. Expenses
decreased $469,000 from $2.7 million during the nine months ended December 31, 2008 to $2.2 million
during the same period in 2009. Included in the three-month period ended December 31, 2008 is
$45,000 non-cash, share-based compensation expense, compared with a charge of $25,000 in the
three-month period ended December 31, 2009. Excluding share-based compensation charges, G&A
expenses decreased by $54,000 during the three months ended December 31, 2009 from the three months
ended December 31, 2008. Included in the nine-month period ended December 31, 2008 is $262,000
non-cash, share-based compensation expense, compared with a charge of $169,000 in the nine-month
period ended December 31, 2009. Excluding share-based compensation charges, G&A expenses decreased
by $376,000 during the nine months ended December 31, 2009 from the nine months ended December 31,
2008. G&A expenses decreased primarily because of a $186,000 decrease in professional and
consulting fees, a $44,000 recovery of a customer receivable which we had reserved for in the prior
fiscal year, a $26,000 decrease in travel costs, and other reductions as we implemented cost
reduction measures. We have implemented concentrated efforts to reduce expenses until
reimbursement in the U.S. for Urgent PC recovers and the economy improves.
Research and Development Expenses (R&D): R&D expenses decreased from $724,000 during the three
months ended December 31, 2008 to $401,000 during the same period in 2009. Expenses decreased from
$1.5 million during the nine months ended December 31, 2008 to $1.4 million during the same period
in 2009. The decrease during the quarter is attributed primarily to a decrease in spending for
clinical studies. The decrease for the nine months ended December 31, 2009 is attributed to a
$59,000 decrease in spending for clinical studies, a $37,000 decrease in travel costs, a $29,000
decrease in consulting expense, a $11,000 decrease in regulatory expenses, offset partially by an
$67,000 increase in compensation related costs. We have undertaken clinical studies that we
anticipate may assist us in obtaining a specific listed CPT code that will encourage broader use
of our Urgent PC. We spent approximately $1.3 million in fiscal 2009, have spent approximately
$364,000 in the nine months ended December 31, 2009 and anticipate spending approximately $100,000
in the remainder of the current fiscal year for such clinical studies.
Selling and Marketing Expenses (S&M): S&M expenses decreased from $2.1 million during the three
months ended December 31, 2008 to $1.7 million during the same period in 2009. Expenses decreased
from $7.3 million during the nine
Page 17
months ended December 31, 2008 to $5.7 million during the same period in 2009. We attribute the decrease during the nine months ended December 31, 2009 to a
$372,000 decrease in commissions due to the decrease in sales, a $378,000 decrease in compensation
related costs on lower headcount and share-based charges, a $273,000 decrease in travel costs, a
$228,000 decrease in cost to support our marketing activities and a $131,000 decrease in
consultancy costs, mainly related to reimbursement. Although we have maintained our assembled U.S.
sales force and redirected some of their effort to our Macroplastique product line until
reimbursement for Urgent PC stabilizes, we have taken steps to control other sales and marketing
expenses.
Amortization of Intangibles: Amortization of intangibles was $211,000 and $212,000 for the three
months ended December 31, 2009 and 2008, respectively, and was $635,000 and $634,000 for the nine
months ended December 31, 2009 and 2008, respectively. In April 2007, we acquired from CystoMedix,
Inc., certain intellectual property assets related to the Urgent PC system for $4.7 million, which
we are amortizing over six years.
Other Income (Expense): Other income (expense) includes interest income, interest expense, foreign
currency exchange gains and losses and other non-operating costs when incurred. Net other income
was $12,000 and $22,000 for the three months ended December 31, 2009 and 2008, respectively, and
was $43,000 and $142,000 for the nine months ended December 31, 2009 and 2008, respectively. The
decline in net other income is attributed primarily to the decline in interest income on lower cash
balance and interest rates.
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
exchange loss of $8,000 and $0 for the three months ended December 31, 2009 and 2008, respectively,
and $23,000 and $731 for the nine months ended December 31, 2009 and 2008, respectively.
Income Tax Expense (Benefit): During the three months ended December 31, 2009 and 2008, we
recorded income tax expense (benefit) of $6,000 and $(5,000), respectively, and $29,000 and $33,000
for the nine months ended December 31, 2009 and 2008, respectively.
Non-GAAP Financial Measures: The following table reconciles our operating loss calculated in
accordance with accounting principles generally accepted in the U.S. (GAAP) to non-GAAP financial
measures that exclude non-cash charges for share-based compensation, and depreciation and
amortization expenses from gross profit, operating expenses and operating loss. The non-GAAP
financial measures used by management and disclosed by us are not a substitute for, or superior to,
financial measures and consolidated financial results calculated in accordance with GAAP, and you
should carefully evaluate our reconciliations to non-GAAP. We may calculate our non-GAAP financial
measures differently from similarly titled measures used by other companies. Therefore, our
non-GAAP financial measures may not be comparable to those used by other companies. We have
described the reconciliations of each of our non-GAAP financial measures described above to the
most directly comparable GAAP financial measures.
We use these non-GAAP financial measures, and in particular non-GAAP operating loss, for internal
managerial purposes and incentive compensation for senior management
because we believe such measures are one important
indicator of the strength and the operating performance of our business. Analysts and investors
frequently ask us for this information. We believe that they use such measures to evaluate the
overall operating performance of companies in our industry, including as a means of comparing
period-to-period results and as a means of evaluating our results with those of other companies.
Page 18
Our non-GAAP operating loss of approximately $42,000 for the three months ended December 31, 2009
was less than the $492,000 operating loss in same period in fiscal 2009. Our non-GAAP operating
loss was approximately $1.4 million for the nine months ended December 31, 2009 compared to an
operating loss of $485,000 in same period fiscal in 2009. We attribute the increased operating
loss during the nine months ended December 31, 2009 primarily to the decrease in sales and a lower
gross margin rate, offset partially by a decrease in cash operating expenses. With continued focus
on spending reductions, we reduced the operating loss for the three months ended December 31, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Gross Profit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP gross profit |
|
$ |
2,562,743 |
|
|
$ |
2,853,298 |
|
|
$ |
7,288,103 |
|
|
$ |
10,042,269 |
|
% of sales |
|
|
84 |
% |
|
|
84 |
% |
|
|
82 |
% |
|
|
85 |
% |
Share-based compensation |
|
|
4,771 |
|
|
|
8,879 |
|
|
|
23,218 |
|
|
|
34,132 |
|
Depreciation expense |
|
|
14,481 |
|
|
|
12,436 |
|
|
|
42,780 |
|
|
|
38,283 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP gross profit |
|
|
2,581,995 |
|
|
|
2,874,613 |
|
|
|
7,354,101 |
|
|
|
10,114,684 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP operating expenses |
|
|
2,955,178 |
|
|
|
3,774,118 |
|
|
|
9,929,140 |
|
|
|
12,012,296 |
|
Share-based compensation |
|
|
60,351 |
|
|
|
136,701 |
|
|
|
333,365 |
|
|
|
601,448 |
|
Depreciation expense |
|
|
59,462 |
|
|
|
58,922 |
|
|
|
175,085 |
|
|
|
178,083 |
|
Amortization expense |
|
|
211,189 |
|
|
|
211,626 |
|
|
|
634,505 |
|
|
|
633,567 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP operating expenses |
|
|
2,624,176 |
|
|
|
3,366,869 |
|
|
|
8,786,185 |
|
|
|
10,599,198 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP operating loss |
|
|
(392,435 |
) |
|
|
(920,820 |
) |
|
|
(2,641,037 |
) |
|
|
(1,970,027 |
) |
Share-based compensation |
|
|
65,122 |
|
|
|
145,580 |
|
|
|
356,583 |
|
|
|
635,580 |
|
Depreciation expense |
|
|
73,943 |
|
|
|
71,358 |
|
|
|
217,865 |
|
|
|
216,366 |
|
Amortization expense |
|
|
211,189 |
|
|
|
211,626 |
|
|
|
634,505 |
|
|
|
633,567 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP operating loss |
|
$ |
(42,181 |
) |
|
$ |
(492,256 |
) |
|
$ |
(1,432,084 |
) |
|
$ |
(484,514 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Liquidity and Capital Resources
Cash Flows.
At December 31, 2009, our cash and cash equivalent and short-term investments balances totaled $5.9
million.
At December 31, 2009, we had working capital of approximately $6.4 million. For the nine months
ended December 31, 2009, we used $1.9 million of cash in operating activities, compared to $0.7
million of cash used in the same period a year ago. We attribute the increase in cash used in
operating activities primarily to the decrease in sales, and a decrease of the gross profit rate,
offset partially by a decrease in cash operating expenses.
For the nine months ended December 31, 2009 we used approximately $70,000 to purchase property,
plant and equipment compared with approximately $181,000 for the same period a year ago.
For the nine months ended December 31, 2008 we used cash in financing activities of approximately
$456,000 to repay debt obligations. In the third quarter of fiscal 2009 we fully retired the debt.
We used no cash in financing activities during the nine months ended December 31, 2009.
Page 19
Sources of Liquidity.
Uroplasty BV, our subsidiary, has an agreement with Rabobank of The Netherlands for a 500,000
(approximately $717,000) credit line. The bank charges interest on the loan at the rate of one
percentage point over the Rabobank base interest rate (4.85% base rate on December 31, 2009),
subject to a minimum interest rate of 3.5% per annum. At December 31, 2009, we had no borrowings
outstanding on this credit line.
On October 30, 2009 we renewed our credit line with Venture Bank. The agreement provides for a
credit line of up to $2 million secured by the assets of our company. We may borrow up to 50% (to
a maximum of $500,000) of the value of our eligible inventory on hand and 80% of the value of our
eligible U.S. accounts receivable; provided, however, our total liabilities, inclusive of the
amount borrowed, may not exceed our tangible net worth. To be eligible to borrow any amount, we
must maintain a minimum tangible net worth of $5 million. At December 31, 2009 we had no
borrowings outstanding under this agreement, but we estimate we had a borrowing capacity of
approximately $0.5 million. Interest on the loan is charged at a per annum rate of the greater of
7.5% or one percentage point over the prime rate (3.25% prime rate on December 31, 2009).
We believe we have sufficient liquidity to meet our needs over the next twelve months. However, we
may need to raise additional financing to support our operations and planned growth activities in
the future as we have yet to achieve profitability and generate positive cash flows. To achieve
profitability, we must generate substantially more revenue than we have this year or in prior
years. Our ability to achieve significant revenue growth will depend, in large part, on our
ability to achieve widespread market acceptance for our products and successfully expand our
business in the U.S., which in turn may be partially dependent upon re-establishing broad
reimbursement for our Urgent PC product and successfully demonstrating the superiority of our
Macroplastique product to clinicians. We cannot guarantee that we will be entirely successful in
either of these pursuits. If we are unable to raise the needed funds, we may need to curtail our
operations including product development, clinical studies and sales and marketing activities.
This would adversely impact our future business and prospects. Ultimately, we will need to achieve
profitability and generate positive cash flows from operations to meet our cash needs and grow our
business.
Commitments and Contingencies.
We discuss our commitments and contingencies in our Annual Report on Form 10-K for the year ended
March 31, 2009. There have been no significant changes in our commitments for capital expenditure
and contractual obligations since March 31, 2009.
We may continue to incur significant costs for clinical studies, beyond those we have expensed to
date, to support broader marketing of our Urgent PC System in the U.S. We expect that in fiscal
2010 we will spend approximately $0.5 million for such clinical studies. We also expect to
continue to incur significant expenses to support our U.S. sales and marketing organization.
|
|
|
ITEM 3. |
|
Quantitative and Qualitative Disclosures about Market Risk |
Not applicable due to our status as a Smaller Reporting Company.
|
|
|
ITEM 4. |
|
Controls and Procedures |
Disclosure Controls and Procedures.
Under the supervision and with the participation of our management, including, our President and
Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of the design
and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e)) under the
Securities Exchange Act of 1934 (the Exchange Act). Based on this evaluation, our Chief
Executive Officer and Chief Financial Officer concluded that, as of the end of the period covered
by this report, our disclosure controls and procedures are effective in ensuring that the
information required to be disclosed by us in the reports that we file or submit under the Exchange
Act is recorded, processed, summarized and reported within the time periods specified in applicable
rules and forms and that such information is accumulated and communicated to our management,
including our Chief Executive Officer and Chief Financial Officer, in a manner that allows timely
decisions regarding required disclosure.
Internal Control Over Financial Reporting.
There were no changes in our internal control over financial reporting during the quarter ended
December 31, 2009, that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
Page 20
PART II. OTHER INFORMATION
|
|
|
ITEM 1. |
|
Legal Proceedings |
None.
There have been no material changes from the risk factors set forth in our Annual Report on Form
10-K for the fiscal year ended March 31, 2009.
|
|
|
ITEM 2. |
|
Unregistered Sales of Equity Securities and Use of Proceeds. |
None.
|
|
|
ITEM 3. |
|
Defaults upon Senior Securities |
None.
|
|
|
ITEM 4. |
|
Submission of Matters to a Vote of Security Holders |
None
|
|
|
ITEM 5. |
|
Other Information |
None.
Exhibits
31.1 Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
32.1 Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (this Exhibit is furnished pursuant to SEC rules,
but is deemed not filed)
Page 21
SIGNATURES
In accordance with the requirements of the Securities Exchange Act of 1934, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
|
UROPLASTY, INC.
|
|
Date: February 1, 2010 |
By: |
/s/ DAVID B. KAYSEN
|
|
|
|
David B. Kaysen |
|
|
|
President and Chief Executive Officer |
|
|
|
|
|
Date: February 1, 2010 |
By: |
/s/ MAHEDI A. JIWANI
|
|
|
|
Mahedi A. Jiwani |
|
|
|
Chief Financial Officer |
|
|
Page 22