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, 2010
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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 (§232.405 of this chapter) during the preceding 12 months (or for such
shorter period that the registrant was required to submit and post such files). 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
(Do not check if a smaller reporting company)
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Smaller Reporting Company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)
YES o NO þ
As of January 25, 2011 the registrant had 20,634,332 shares of common stock outstanding.
Table of Contents
INDEX
UROPLASTY INC. AND SUBSIDIARIES
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3 |
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3 |
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5 |
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6 |
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7 |
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8 |
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16 |
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22 |
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22 |
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22 |
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22 |
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22 |
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22 |
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22 |
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22 |
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22 |
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23 |
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Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to Section 302 |
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Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to Section 906 |
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EX-31.1 |
EX-32.1 |
EX-99.1 |
Page 2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
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December 31, 2010 |
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March 31, 2010 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
5,044,741 |
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$ |
2,311,269 |
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Short-term investments |
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9,777,894 |
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3,500,000 |
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Accounts receivable, net |
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1,547,665 |
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1,287,440 |
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Inventories |
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592,181 |
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341,497 |
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Income tax receivable |
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23,820 |
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Other |
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308,137 |
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237,321 |
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Total current assets |
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17,270,618 |
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7,701,347 |
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Property, plant, and equipment, net |
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1,133,179 |
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1,230,771 |
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Intangible assets, net |
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1,911,887 |
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2,533,095 |
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Long-term investments |
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6,009,337 |
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Deferred tax assets |
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112,907 |
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108,530 |
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Total assets |
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$ |
26,437,928 |
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$ |
11,573,743 |
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See accompanying notes to the condensed consolidated financial statements.
Page 3
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
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December 31, 2010 |
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March 31, 2010 |
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Liabilities and Shareholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
489,093 |
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$ |
485,594 |
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Current portion deferred rent |
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35,000 |
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35,000 |
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Income tax payable |
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12,487 |
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10,000 |
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Accrued liabilities: |
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Compensation |
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1,476,238 |
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903,057 |
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Other |
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251,455 |
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212,028 |
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Total current liabilities |
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2,264,273 |
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1,645,679 |
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Deferred rent less current portion |
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86,079 |
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112,500 |
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Accrued pension liability |
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578,262 |
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601,037 |
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Total liabilities |
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2,928,614 |
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2,359,216 |
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Commitments and Contingencies |
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Shareholders equity: |
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Common stock $.01 par value; 40,000,000
shares authorized, 20,634,332 and
14,946,540 shares issued and
outstanding at December 31, 2010 and
March 31, 2010, respectively |
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206,343 |
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149,465 |
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Additional paid-in capital |
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53,794,136 |
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36,178,126 |
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Accumulated deficit |
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(29,937,072 |
) |
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(26,617,161 |
) |
Accumulated other comprehensive loss |
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(554,093 |
) |
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(495,903 |
) |
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Total shareholders equity |
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23,509,314 |
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9,214,527 |
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Total liabilities and shareholders equity |
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$ |
26,437,928 |
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$ |
11,573,743 |
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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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2010 |
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2009 |
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2010 |
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2009 |
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Net sales |
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$ |
3,492,067 |
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$ |
3,068,142 |
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$ |
9,772,389 |
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$ |
8,880,546 |
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Cost of goods sold |
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604,566 |
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505,399 |
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1,709,731 |
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1,592,443 |
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Gross profit |
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2,887,501 |
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2,562,743 |
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8,062,658 |
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7,288,103 |
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Operating expenses |
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General and administrative |
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861,183 |
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639,608 |
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2,608,868 |
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2,201,199 |
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Research and development |
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423,794 |
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401,481 |
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1,296,431 |
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1,365,194 |
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Selling and marketing |
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2,871,456 |
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1,702,900 |
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6,877,402 |
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5,728,242 |
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Amortization |
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211,058 |
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211,189 |
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632,508 |
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634,505 |
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4,367,491 |
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2,955,178 |
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11,415,209 |
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9,929,140 |
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Operating loss |
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(1,479,990 |
) |
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(392,435 |
) |
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(3,352,551 |
) |
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(2,641,037 |
) |
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Other income (expense) |
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Interest income |
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21,135 |
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21,468 |
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52,762 |
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77,097 |
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Interest expense |
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(652 |
) |
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(1,291 |
) |
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(4,537 |
) |
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(10,986 |
) |
Foreign currency exchange gain (loss) |
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503 |
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(8,335 |
) |
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12,867 |
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(23,030 |
) |
Other, net |
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(192 |
) |
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(183 |
) |
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20,986 |
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11,842 |
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60,900 |
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42,898 |
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Loss before income taxes |
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(1,459,004 |
) |
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(380,593 |
) |
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(3,291,651 |
) |
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(2,598,139 |
) |
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Income tax expense |
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8,927 |
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6,143 |
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28,260 |
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29,030 |
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Net loss |
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$ |
(1,467,931 |
) |
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$ |
(386,736 |
) |
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$ |
(3,319,911 |
) |
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$ |
(2,627,169 |
) |
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Basic and diluted loss per common share |
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$ |
(0.07 |
) |
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$ |
(0.03 |
) |
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$ |
(0.18 |
) |
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$ |
(0.18 |
) |
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Weighted average common shares
outstanding: |
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Basic and diluted |
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20,514,530 |
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14,946,540 |
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18,314,157 |
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14,943,638 |
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See accompanying notes to the condensed consolidated financial statements.
Page 5
UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERSEQUITY AND COMPREHENSIVE LOSS
Nine Months Ended December 31, 2010
(Unaudited)
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Accumulated |
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Additional |
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Accumulated |
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Other |
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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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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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Loss |
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Equity |
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Balance at March 31, 2010 |
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14,946,540 |
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$ |
149,465 |
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$ |
36,178,126 |
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$ |
(26,617,161 |
) |
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$ |
(495,903 |
) |
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$ |
9,214,527 |
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Proceeds from public
offering, net of costs
of $1,182,941 |
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4,600,000 |
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46,000 |
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14,871,059 |
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14,917,059 |
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Share-based consulting
and compensation |
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72,900 |
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|
729 |
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|
288,093 |
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288,822 |
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Proceeds from exercise
of warrants |
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886,000 |
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|
8,860 |
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|
2,190,322 |
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2,199,182 |
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Proceeds from exercise
of stock options, net of
1,608 shares returned
for payment of related
income taxes |
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|
128,892 |
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|
1,289 |
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|
266,536 |
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|
267,825 |
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Comprehensive loss |
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(3,319,911 |
) |
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|
(58,190 |
) |
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|
(3,378,101 |
) |
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|
Balance at December 31,
2010 |
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|
20,634,332 |
|
|
$ |
206,343 |
|
|
$ |
53,794,136 |
|
|
$ |
(29,937,072 |
) |
|
$ |
(554,093 |
) |
|
$ |
23,509,314 |
|
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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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|
2010 |
|
|
2009 |
|
Cash flows from operating activities: |
|
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|
|
|
|
|
|
Net loss |
|
$ |
(3,319,911 |
) |
|
$ |
(2,627,169 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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|
|
|
|
|
|
Depreciation and amortization |
|
|
848,385 |
|
|
|
852,370 |
|
Loss on disposal of equipment |
|
|
192 |
|
|
|
183 |
|
Amortization of premium on marketable securities |
|
|
7,226 |
|
|
|
|
|
Share-based consulting expense |
|
|
9,739 |
|
|
|
|
|
Share-based compensation expense |
|
|
279,083 |
|
|
|
356,583 |
|
Deferred income taxes |
|
|
(5,863 |
) |
|
|
(5,299 |
) |
Deferred rent |
|
|
(26,421 |
) |
|
|
(26,250 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(261,136 |
) |
|
|
71,404 |
|
Inventories |
|
|
(248,656 |
) |
|
|
112,460 |
|
Other current assets and income tax receivable |
|
|
(48,492 |
) |
|
|
(44,238 |
) |
Accounts payable |
|
|
4,474 |
|
|
|
(324,094 |
) |
Accrued liabilities |
|
|
610,710 |
|
|
|
(221,266 |
) |
Accrued pension liability, net and income tax payable |
|
|
(10,783 |
) |
|
|
(20,141 |
) |
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(2,161,453 |
) |
|
|
(1,875,457 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Proceeds from maturity of marketable securities |
|
|
4,000,000 |
|
|
|
3,000,000 |
|
Purchases of marketable securities |
|
|
(16,311,352 |
) |
|
|
(2,000,000 |
) |
Purchases of property, plant and equipment |
|
|
(128,935 |
) |
|
|
(70,354 |
) |
Purchase of intangible assets |
|
|
(11,300 |
) |
|
|
|
|
Proceeds from sale of property, plant and equipment |
|
|
|
|
|
|
2,000 |
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
|
(12,451,587 |
) |
|
|
931,646 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Net proceeds from public offering of common stock |
|
|
14,917,059 |
|
|
|
|
|
Net proceeds from exercise of warrants and options |
|
|
2,467,007 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
17,384,066 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
(37,554 |
) |
|
|
70,644 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
2,733,472 |
|
|
|
(873,167 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
2,311,269 |
|
|
|
3,276,299 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
5,044,741 |
|
|
$ |
2,403,132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
|
|
|
$ |
6,145 |
|
Cash paid during the period for income taxes |
|
|
9,633 |
|
|
|
121,655 |
|
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, 2010.
The condensed consolidated financial statements presented herein as of December 31, 2010 and for
the three and nine month periods ended December 31, 2010 and 2009 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,
2010. 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, 2010 and 2009, and we
have made no changes to these policies during fiscal 2011.
2. Cash Equivalents and Marketable Securities
We consider all highly liquid investments with original maturities of three-months or less when
purchased to be cash equivalents. We classify marketable securities having original maturities of
one year or less, but more than three months, as short-term investments and marketable securities
with maturities of more than one year as long-term investments. We further classify marketable
securities as either held-to-maturity or available-for-sale. We classify marketable securities as
held-to-maturity when we believe we have the ability and intent to hold such securities to their
scheduled maturity dates. All other marketable securities are classified as available-for-sale.
We have not designated any of our marketable securities as trading securities.
We carry held-to-maturity marketable securities at their amortized cost and available-for-sale
marketable securities at their fair value and report any unrealized appreciation or depreciation in
the fair value of available-for-sale marketable securities in accumulated other comprehensive
income. We monitor our investment portfolio for any decline in fair value that is
other-than-temporary and record any such impairment as an impairment loss. We recorded no
impairment losses for other-than-temporary declines in the fair value of marketable securities for
the three and nine months ended December 31, 2010 and December 31, 2009.
Cash and cash equivalents include highly liquid money market funds of $3.8 million and $1.4 million
as of December 31, 2010 and March 31, 2010, respectively.
As of March 31, 2010, we did not have any available-for-sale marketable securities. The amortized
cost and fair value of our marketable securities classified as available-for-sale as of December
31, 2010 are summarized as follows:
Page 8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government
and Agency debt
securities |
|
$ |
5,282,014 |
|
|
$ |
|
|
|
$ |
4,120 |
|
|
$ |
5,277,894 |
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government
and Agency debt
securities |
|
|
6,022,112 |
|
|
|
|
|
|
|
12,775 |
|
|
|
6,009,337 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
11,304,126 |
|
|
$ |
|
|
|
$ |
16,895 |
|
|
$ |
11,287,231 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments include held to maturity certificates of deposit with maturities of less
than twelve months of $4.5 million and $3.5 million as of December 31, 2010 and March 31, 2010,
respectively. Due to the negligible risk of changes in value due to changes in interest rates and
the short-term nature of these investments, their cost approximates their fair market value.
3. Fair Value Measurements
Estimates of fair value for financial assets and liabilities are based on the framework established
in the accounting guidance for fair value measurements. The framework defines fair value, provides
guidance for measuring fair value and requires certain disclosures. The framework prioritizes a
fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize
the use of unobservable inputs when measuring fair value. The following three broad levels of
inputs may be used to measure fair value under the fair value hierarchy:
Level 1 Quoted prices available in active markets for identical assets or liabilities at the
measurement date.
Level 2 Significant other observable inputs available at the measurement date, other than quoted
prices included in Level 1, either directly or indirectly, including:
|
|
|
Quoted prices for similar assets or liabilities in active markets; |
|
|
|
|
Quoted prices for identical or similar assets in non-active markets; |
|
|
|
|
Inputs other than quoted prices that are observable for the asset or liability; and |
|
|
|
|
Inputs that are derived principally from or corroborated by other observable market
data. |
Level 3 Significant unobservable inputs that cannot be corroborated by observable market data and
reflect the use of significant management judgment. These values are generally determined using
pricing models for which the assumptions utilize managements estimates of market participant
assumptions.
If the inputs used to measure the financial assets and liabilities fall within more than one of the
different levels described above, the categorization is based on the lowest level input that is
significant to the fair value measurement of the instrument.
The following table provides the assets carried at fair value measured on a recurring basis as of
December 31, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Prices |
|
|
|
|
|
|
|
|
|
|
|
|
|
in Active |
|
|
|
|
|
|
|
|
|
|
|
|
|
Markets for |
|
|
Significant Other |
|
|
Significant |
|
|
|
|
|
|
|
Identical |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
|
|
|
Assets |
|
|
Inputs |
|
|
Inputs |
|
Asset Class |
|
Fair Value |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
3,840,022 |
|
|
$ |
3,840,022 |
|
|
$ |
|
|
|
$ |
|
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
4,500,000 |
|
|
|
4,500,000 |
|
|
|
|
|
|
|
|
|
U.S.
Government and Agency
debt securities |
|
|
5,276,868 |
|
|
|
499,540 |
|
|
|
4,777,328 |
|
|
|
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government and
Agency debt securities |
|
|
6,010,363 |
|
|
|
|
|
|
|
6,010,363 |
|
|
|
|
|
Pension plan assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested Benefit
Obligation
(Netherlands Plan) |
|
|
1,252,104 |
|
|
|
|
|
|
|
|
|
|
|
1,252,104 |
|
Deposit Administration
Contract (U.K. Plan) |
|
|
476,784 |
|
|
|
|
|
|
|
476,784 |
|
|
|
|
|
Page 9
Money market funds. Highly liquid investments with original maturities of three months or less
when purchased. They present negligible risk of changes in value due to changes in interest rates,
and their cost approximates their fair market value.
Certificates of deposit. Our certificates of deposit are held-to-maturity and mature within the
next twelve months. Based on the negligible risk of changes in value due to changes in interest
rates and the short-term nature of these investments, their cost approximates their fair market
value.
U.S. Government and U.S. Government Agency debt securities. Our debt securities consist of bonds,
notes and treasury bills with risk ratings of AAA/Aaa and maturity dates within two years from date
of purchase. The estimated fair value of these securities is based on valuations provided by
external investment managers.
Pension assets. The market value (Vested Benefit Obligation, or VBO) of our Netherlands pension
plan assets is determined using the discounted stream of guaranteed benefit payments at a market
rate, and other unobservable assumptions such as mortality rates. Accordingly, we have classified
the VBO as a Level 3 asset. The market value of the U.K. plan reflects the value of our
contributions to the plan and accrued interest credited to the plan assets at the rate specified in
the Deposit Administration Contract.
Measurements to fair value on a nonrecurring basis relate primarily to our tangible fixed assets
and other intangible assets and occur when the derived fair value is below carrying value on our
condensed consolidated balance sheet. We had no significant remeasurements of such assets or
liabilities to fair value for the three and nine months ended December 31, 2010 and December 31,
2009.
Our financial instruments, other than those presented in the disclosures above, include cash,
receivables, inventories, accounts payable and other payables, and their carrying values
approximate their fair values based of the short-term nature of these instruments.
4. 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 $11,000 at December 31, 2010 and March 31, 2010, respectively.
5. Inventories
Inventories are stated at the lower of cost (first-in,
first-out method) or market (net realizable value).
Inventories consist of the following:
Page 10
|
|
|
|
|
|
|
|
|
|
|
December 31, 2010 |
|
|
March 31, 2010 |
|
Raw materials |
|
$ |
204,048 |
|
|
$ |
158,942 |
|
Work-in-process |
|
|
37,928 |
|
|
|
28,935 |
|
Finished goods |
|
|
350,205 |
|
|
|
153,620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
592,181 |
|
|
$ |
341,497 |
|
|
|
|
|
|
|
|
6. Intangible Assets
Our intangible assets are comprised of patents which we amortize on a straight-line basis over their estimated useful
lives of six years.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
|
|
carrying |
|
|
Accumulated |
|
|
|
|
|
|
amount |
|
|
amortization |
|
|
Net value |
|
December 31, 2010 |
|
$ |
5,510,102 |
|
|
$ |
3,598,215 |
|
|
$ |
1,911,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2010 |
|
$ |
5,472,512 |
|
|
$ |
2,939,417 |
|
|
$ |
2,533,095 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated annual amortization for these assets for the fiscal years ending March 31, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Remainder of 2011 |
|
|
|
|
|
|
|
|
|
$ |
211,000 |
|
2012 |
|
|
|
|
|
|
|
|
|
|
844,000 |
|
2013 |
|
|
|
|
|
|
|
|
|
|
844,000 |
|
2014 |
|
|
|
|
|
|
|
|
|
|
6,000 |
|
2015 and beyond |
|
|
|
|
|
|
|
|
|
|
7,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,912,000 |
|
|
|
|
|
|
|
|
|
|
|
|
7. 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. We are amortizing the leasehold improvements over
the shorter of the asset life or the lease term.
8. Comprehensive Loss
Comprehensive loss includes our net loss, accumulated translation adjustment, unrealized loss on
available for sale investments, and change in minimum pension obligation as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31 |
|
|
December 31 |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Net loss |
|
$ |
(1,467,931 |
) |
|
$ |
(386,736 |
) |
|
$ |
(3,319,911 |
) |
|
$ |
(2,627,169 |
) |
Items of other comprehensive
income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
(39,155 |
) |
|
|
(30,808 |
) |
|
|
(39,657 |
) |
|
|
145,259 |
|
Unrealized loss on
available for sale
investments |
|
|
(16,895 |
) |
|
|
|
|
|
|
(16,895 |
) |
|
|
|
|
Pension related |
|
|
9,334 |
|
|
|
1,475 |
|
|
|
(1,638 |
) |
|
|
(3,242 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(1,514,647 |
) |
|
$ |
(416,069 |
) |
|
$ |
(3,378,101 |
) |
|
$ |
(2,485,152 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Page 11
Other accumulated comprehensive loss at December 31, 2010 totaled $554,093 and consists of $157,402
for accumulated translation adjustment, $16,895 for unrealized loss on available for sale
investments and $379,796 for accumulated additional pension liability.
9. Net Loss per Common Share
The following unvested restricted stock, options and warrants
outstanding at December 31, 2010 and 2009, to purchase shares
of common stock, were excluded from diluted loss per common
share because of their anti-dilutive effect:
|
|
|
|
|
|
|
|
|
Number of unvested |
|
|
|
|
restricted stock/ |
|
Range of |
|
|
options/warrants |
|
exercise prices |
December 31, 2010
|
|
|
2,155,200 |
|
$0.71 to $5.64 |
December 31, 2009
|
|
|
4,141,928 |
|
$0.71 to $5.19 |
10. Credit Facilities
Uroplasty BV, our subsidiary, has an agreement with Rabobank of The Netherlands for a 500,000
(approximately $663,000 as of December 31, 2010) credit line. The bank charges interest on the
loan at the rate of one percentage point over the Rabobank base interest rate (4.25% base rate on
December 31, 2010), subject to a minimum interest rate of 3.50% per annum. We had no borrowings
outstanding on this credit line at December 31, 2010 and March 31, 2010.
11. Warrants
The following table summarizes the activity during the nine
months ended December 31, 2010 related to warrants to purchase
our common shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
average |
|
|
|
Number of |
|
|
exercise |
|
|
|
shares |
|
|
price |
|
Outstanding at March 31, 2010
|
|
|
2,066,928 |
|
|
$ |
3.78 |
|
Warrants expired
|
|
|
(1,180,928 |
) |
|
|
4.75 |
|
Warrants exercised
|
|
|
(886,000 |
) |
|
|
2.49 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine months ended December 31, 2010, we received
proceeds of approximately $2.2 million from the exercise of
warrants.
12. Share-based Compensation
As of December 31, 2010, 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, 2010, we had 1,264,700 shares remaining that were 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 incurred approximately $289,000 and $357,000 in share-based compensation expense (inclusive of
$10,000 and $0, respectively, for option grants to consultants) for the nine months ended December
31, 2010 and 2009, respectively.
Page 12
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, 2010 |
|
|
December 31, 2009 |
|
Expected life in years |
|
|
5.33 |
|
|
|
4.83 |
|
Risk-free interest rate |
|
|
1.76 |
% |
|
|
2.74 |
% |
Expected volatility |
|
|
90.89 |
% |
|
|
94.21 |
% |
Expected dividend yield |
|
|
0 |
|
|
|
0 |
|
Weighted-average fair value |
|
$ |
3.45 |
|
|
$ |
0.60 |
|
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 13.80% based on
our historical experience.
The following table summarizes the activity related to our stock options during the nine months ended December 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
average |
|
|
average |
|
|
Aggregate |
|
|
|
Number of |
|
|
exercise |
|
|
remaining |
|
|
intrinsic |
|
|
|
shares |
|
|
price |
|
|
life in years |
|
|
value |
|
Outstanding at March 31, 2010 |
|
|
2,037,500 |
|
|
$ |
3.14 |
|
|
|
4.00 |
|
|
$ |
506,000 |
|
Options granted |
|
|
215,300 |
|
|
|
4.88 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(130,500 |
) |
|
|
2.11 |
|
|
|
|
|
|
|
|
|
Options surrendered |
|
|
(40,000 |
) |
|
|
4.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2010 |
|
|
2,082,300 |
|
|
$ |
3.36 |
|
|
|
3.81 |
|
|
$ |
2,208,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2010 |
|
|
1,769,498 |
|
|
$ |
3.33 |
|
|
|
3.51 |
|
|
$ |
1,883,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our 2006 Stock and Incentive Plan also allows for our Compensation Committee to grant other stock-based benefits, including restricted shares.
Restricted shares are subject to risk of forfeiture for termination of employment. The forfeiture risk generally lapses over a period of four years.
The following table summarizes the activity related to our restricted shares during the nine months
ended December 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
average |
|
|
average |
|
|
Aggregate |
|
|
|
Number of |
|
|
grant date |
|
|
remaining |
|
|
intrinsic |
|
|
|
Shares |
|
|
fair value |
|
|
life in years |
|
|
value |
|
Balance at March 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares granted |
|
|
72,900 |
|
|
$ |
4.76 |
|
|
|
|
|
|
|
|
|
Shares vested |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2010 |
|
|
72,900 |
|
|
$ |
4.76 |
|
|
|
1.45 |
|
|
$ |
347,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
Page 13
As of December 31, 2010, we had approximately $947,000 of unrecognized share-based compensation
expense, net of estimated forfeitures, related to stock options and restricted shares that we
expect to recognize over a weighted-average period of 2.14 years.
13. Savings and Retirement Plans
We sponsor various plans for eligible employees in the United States, the United Kingdom (UK), and
The Netherlands. Our retirement savings plan in the United States conforms to Section 401(k) of the
Internal Revenue Code and participation is available to substantially all employees. We may also
make discretionary contributions ratably to all eligible employees. We made no discretionary
contributions to the U.S. plan for the nine months ended December 31, 2010 and made discretionary
contributions of $105,000 for the nine months ended December 31, 2009.
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 a
defined contribution plan for them.
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, 2010 and
2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31 |
|
|
December 31 |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Gross service cost |
|
$ |
24,614 |
|
|
$ |
16,692 |
|
|
$ |
71,076 |
|
|
$ |
48,278 |
|
Interest cost |
|
|
29,136 |
|
|
|
24,152 |
|
|
|
84,404 |
|
|
|
70,205 |
|
Expected return on assets |
|
|
(12,746 |
) |
|
|
1,579 |
|
|
|
(37,026 |
) |
|
|
4,188 |
|
Amortization |
|
|
4,285 |
|
|
|
(117 |
) |
|
|
12,481 |
|
|
|
(337 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic retirement cost |
|
$ |
45,289 |
|
|
$ |
42,306 |
|
|
$ |
130,935 |
|
|
$ |
122,334 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Major assumptions used in the above calculations include:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
December 31 |
|
|
|
2010 |
|
|
2009 |
|
Discount rate |
|
|
4.70-5.50 |
% |
|
|
6.60-6.70 |
% |
Expected return on assets |
|
|
4.70-5.00 |
% |
|
|
5.00-6.60 |
% |
Expected rate of increase
in future compensation: |
|
|
|
|
|
|
|
|
General |
|
|
3.00 |
% |
|
|
3.00 |
% |
Individual |
|
|
0.00-3.00 |
% |
|
|
0.00-3.00 |
% |
Both the Netherlands and United Kingdom pension plans are in an underfunded position and the funded
status of the plans is shown as accrued pension liability. We made aggregate contributions of
approximately $144,000 and $142,000, respectively, during the nine months ended December 31, 2010
and 2009 to the two defined benefit plans.
14. Equity Offering
We completed a public offering of 4.6 million shares of our common stock at $3.50 per share in July
2010, generating gross proceeds of $16.1 million, and net proceeds, after fees and expenses, of
approximately $14.9 million. We anticipate using
Page 14
the proceeds to expand our U.S. sales and marketing organization to support our Urgent PC business and for clinical studies, working capital
and general corporate purposes.
15. 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 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,
2010 and 2009, we recognized foreign currency exchange gain of $503 and foreign currency exchange
loss of $8,335, respectively. For the nine months ended December 31, 2010 and 2009, we recognized
currency exchange gain of $12,867 and currency exchange loss of $23,030, respectively.
16. Business Segment Information
We aggregate our operating segments into one reportable segment in accordance with the objectives
and principles of the applicable guidance.
Sales to customers outside the United States for the three months ended December 31, 2010 and 2009 represented 42% and 51%,
respectively, of our consolidated sales. Sales to customers outside the United States for the nine months ended December 31, 2010
and 2009 represented 44% and 50%, respectively, of our consolidated sales. Information regarding sales to customers by geographic
area for the three- and nine- month periods ended December 31 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All Other |
|
|
|
|
|
|
United |
|
|
United |
|
|
Foreign |
|
|
|
|
|
|
States |
|
|
Kingdom |
|
|
Countries |
|
|
Consolidated |
|
Three months ended
December 31, 2010 |
|
$ |
2,010,062 |
|
|
$ |
379,356 |
|
|
$ |
1,102,649 |
|
|
$ |
3,492,067 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
December 31, 2009 |
|
$ |
1,514,489 |
|
|
$ |
372,701 |
|
|
$ |
1,180,952 |
|
|
$ |
3,068,142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
December 31, 2010 |
|
$ |
5,475,888 |
|
|
$ |
1,115,749 |
|
|
$ |
3,180,752 |
|
|
$ |
9,772,389 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
December 31, 2009 |
|
$ |
4,477,944 |
|
|
$ |
1,156,412 |
|
|
$ |
3,246,190 |
|
|
$ |
8,880,546 |
|
Information regarding location of our long-lived assets by geographic area at December 31, 2010 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United |
|
|
United |
|
|
The |
|
|
|
|
|
|
States |
|
|
Kingdom |
|
|
Netherlands |
|
|
Consolidated |
|
|
|
$ |
473,102 |
|
|
$ |
2,282 |
|
|
$ |
657,795 |
|
|
$ |
1,133,179 |
|
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.
17. Income Tax Expense
Page 15
As of March 31, 2010, we have generated approximately $25 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 is subject to certain limitations under
Section 382 of the Internal Revenue Code. This section generally relates to a 50 percent change in
ownership of a company over a three-year period. We believe that the issuance of our common stock
in the July 2010 public offering resulted in an ownership change under Section 382. Accordingly,
our ability to use NOL tax attributes generated prior to July 2010 may be limited.
During the three months ended December 31, 2010 and 2009, we recorded income tax expense of
approximately $9,000 and $6,000, respectively, for foreign income taxes, and for required minimum
payments for U.S. income taxes. During the nine months ended December 31, 2010 and 2009, we
recorded income tax expense of approximately $28,000 and $29,000, respectively.
On December 31, 2010 we had a deferred tax asset of $113,000. 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.
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. We have 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, we
have no reserve for uncertain tax positions recorded in our consolidated financial statements.
Under our accounting policies, we recognize interest and penalties accrued on unrecognized tax
benefits as well as interest received from favorable tax settlements within income tax expense.
The tax returns for fiscal years ended March 31, 2008 through March 31, 2010 remain open to
examination by the Internal Revenue Service and tax returns for fiscal years ended March 31, 2007
through March 31, 2010 remain open to examination by 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 2008 through 2010 remain open for examination.
18. Recently Issued Accounting Standards
In January 2010, the Financial Accounting Standards Board issued Accounting Standards Update
(ASU) No. 2010-06, Fair Value Measurements and Disclosures : Improving Disclosures about Fair
Value Measurements (ASU 2010-06). This update provides amendments to ASC 820-10 that require new
disclosures and clarify existing disclosures. Part of the ASU was effective for the fourth quarter
of our fiscal 2010. The adoption did not have an impact on our financial position or results of
operations. The disclosures about purchase, sales, issuances, and settlements in the roll forward
of activity in level 3 fair value measurements become effective starting our fourth quarter of
fiscal 2011. We do not anticipate adoption to have an impact on our financial position or results
of operations.
19. Subsequent events
We evaluated all subsequent events to ensure that we have included in this Form 10-Q appropriate
disclosure of events both recognized in the financial statements as of December 31, 2010 and events
which occurred subsequent to December 31, 2010 but were not recognized 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, 2010.
Forward-looking Statements
Page 16
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,
2010.
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,
2010. Based upon our review, we have determined that these policies remain our most critical
accounting policies for the nine-month period ended December 31, 2010, and we have made no changes
to these policies during fiscal 2011.
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: the Urgent® PC Neuromodulation System, which we believe is the only
FDA-cleared 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 minimally invasive, soft-tissue urethral bulking
agent for the treatment of adult female stress urinary incontinence primarily due to intrinsic
sphincter deficiency. Outside of the U.S., our Urgent PC is also approved for treatment of fecal
incontinence, and our soft tissue bulking agent is also approved for treatment of male incontinence
and vesicoureteral reflux.
Our sales growth during fiscal 2007 and 2008 was largely attributable to rapid market acceptance of
our Urgent PC product in the U.S. However, our sales performance in the U.S. was impacted by the
American Medical Associations (AMA) advice to the medical community, during our first fiscal
quarter of 2009, that the previously recommended unique, listed Current Procedure Technology (CPT)
code for reimbursement for Percutaneous Tibial Nerve Stimulation (PTNS) treatments using our Urgent
PC be replaced with an unlisted code. As a result, some third-party insurers delayed or denied
reimbursement while other third party payers continued to provide reimbursement for PTNS treatments
under published positive coverage policy or on a case-by-case basis, and our Urgent PC sales in the
U.S. declined from a peak of about $2 million in the first fiscal quarter of 2009 to a range of
$0.9 million to $1million per quarter thereafter.
A major part of our strategy to reverse this trend, supported by publication of clinical studies in
peer-reviewed journals in the U.S., was to obtain a unique, listed category I CPT code for PTNS
treatments, which was granted to us by the AMA and becomes effective in January 2011.
Additionally, in order for our business to grow, we will need to expand third-party reimbursement
coverage for PTNS treatments. Our initial focus for expanding reimbursement coverage is on
Medicare carriers, but we also expect to target selected private payers. Accordingly, we
instituted a comprehensive program designed to educate Medicare carriers and private payer medical
directors about the benefits and clinical study results of PTNS treatments using Urgent PC that we
anticipate will help us secure reimbursement coverage.
As of January 2011, we have information that nine regional Medicare carriers representing 29
states, with approximately 28 million covered lives, have indicated they will provide insurance
coverage for PTNS treatments, and one regional Medicare carrier representing five states, with
approximately two million covered lives, has indicated they will cover on a case-by-case basis.
Three regional Medicare carriers representing 16 states, with approximately 17 million covered
lives, continue to
Page 17
decline reimbursement coverage for PTNS treatments. We are working to change the case-by-case
coverage to routine coverage and to have the decision to deny coverage be reversed. Our plans are
to meet with the Medical directors of these respective carriers to present additional data that we
believe justifies a change in their coverage decision and, if need be, initiate a formal appeal
process. We do not anticipate this process to be completed in our current fiscal year and cannot
be assured that we will be successful in causing the carriers to change their decisions.
We believe the availability of a unique, listed Category I CPT code for PTNS treatments will
encourage broader use of our Urgent PC product, but there is no assurance that additional payers
will agree to create coverage policies. Further, we cannot be certain that the reimbursement
payments the physicians receive from private payers or under Medicare for PTNS treatments will be
adequate to justify the cost of our product.
In anticipation of increased interest in our Urgent PC after the new CPT code is effective, we have
expanded our U.S. field sales and support organization. On December 31, 2010, we had 31 employed
sales representatives and 2 independent manufacturers representatives, up from 19 employed sales
representative and 4 independent manufacturers representatives on September 30, 2010. Our
employed sales representatives generated approximately 89% of our U.S. sales in the third quarter
of fiscal 2011. We expect our employed sales representatives to generate a greater portion of our
sales in the future. We anticipate we will continue to expand our U.S. field sales organization in
the future, depending upon the potential market acceptance of our Urgent PC.
To assist with the funding of these increased sales expenses and working capital, we completed a
public offering of 4.6 million shares of our common stock at $3.50 per share in July 2010,
generating gross proceeds of $16.1 million, and net proceeds, after fees and expenses, of
approximately $14.9 million.
Results of Operations
Three and nine months ended December 31, 2010 compared to three and nine months ended December 31,
2009
Net Sales: During the three months ended December 31, 2010, net sales of $3.5 million represented
a $424,000, or a 14% increase, over net sales of $3.1 million for the three months ended December
31, 2009. Excluding the translation impact of fluctuations in foreign currency exchange rates,
sales increased by approximately 17%. During the nine months ended December 31, 2010, net sales of
$9.8 million represented an increase of $892,000, or 10%, over net sales of $8.9 million for the
nine months ended December 31, 2009. Excluding the translation impact of fluctuations in foreign
currency exchange rates, sales increased by approximately 14%.
Sales to customers in the U.S. of $2.0 million during the three months ended December 31, 2010,
represented an increase of $496,000, or 33%, over net sales of $1.5 million for the three months
ended December 31, 2009. During the nine months ended December 31, 2010 sales to customer in the
U.S. totaled $5.5 million, representing a 22% increase, over net sales of $4.5 million for the nine
months ended December 31, 2009.
Sales in the U.S. of our Urgent PC product, increased 10% to $1.0 million for three months ended
December 31, 2010, from $934,000 for the same year-ago period, and for the nine months ended
December 31, 2010 increased 1% to approximately $3 million. Sales of our Urgent PC system have
declined from a peak of about $2.0 million in the first fiscal quarter of 2009 to approximately $.9
million to $1 million per quarter thereafter because of the reimbursement-related issues noted
previously.
In the third quarter ended December 31, 2010 in the U.S., we sold 1,379 Urgent PC lead set boxes to
236 customers compared to 1,355 boxes to 185 customers in the second quarter ended September 30,
2010. We saw an increase in the number of customers in the third quarter, particularly in late
December, as customers have started to ramp-up their practice in light of the decision by several
Medicare carriers to cover PTNS treatments.
Sales in the U.S. of our Macroplastique product, increased 64% to $925,000 for the three months
ended December 31, 2010, from $565,000 for the same year-ago period, and for the nine months ended
December 31, 2010 increased 60% to $2.4 million from $1.5 million for the same year-ago period.
Sales of our Macroplastique product increased over the corresponding year-ago period because of our
increased sales and marketing focus of this product.
Sales to customers outside the U.S. for the three months ended December 31, 2010 and 2009 were $1.5
million and $1.6 million, respectively, a decrease of 5%. Excluding the translation impact of
fluctuations in foreign currency exchange rates, sales increased by approximately 2%. For the nine
months ended December 31, 2010 and 2009 sales were $4.3 million and $4.4 million, respectively, a
decrease of 2%. Excluding the translation impact of fluctuations in foreign currency exchange
rates, sales increased by approximately 5%.
Page 18
Gross Profit: Gross profit was $2.9 million and $2.6 million for the three months ended December
31, 2010 and 2009, respectively, or 83% and 84% of net sales, respectively. Gross profit was $8.1
million and $7.3 million for the nine months ended December 31, 2010 and 2009, respectively, or 83%
and 82% of net sales, respectively. We attribute the slight decline in the gross profit percentage
for the three months December 31, 2010 primarily to the negative impact of changes in the currency
exchange rates from our foreign currency-denominated sales, offset partially by the favorable
impact of increase in manufacturing capacity utilization. We attribute the slightly higher gross
profit percentage for the nine months ended December 31, 2010 primarily to the favorable impact of
an increase in manufacturing capacity utilization as a result of the increased sales. This
favorable impact was offset partially by the negative impact of the additional costs associated
with the sourcing of our Urgent PC lead sets from a secondary supplier for part of our first and
second quarter of fiscal year 2011. We estimate this negative impact to be approximately one
percentage point in the nine-month period ended December 31, 2010.
General and Administrative Expenses (G&A): G&A expenses of $861,000 during the three months ended
December 31, 2010, increased $221,000 from $640,000 during the same period in 2009. Included in
the three-month period ended December 31, 2010 is a $100,000 non-cash, share-based compensation
expense, compared with a similar charge of $25,000 in the three-month period ended December 31,
2009. Excluding share-based compensation charges, G&A expenses increased by $147,000, primarily
because of a $44,000 increase in investor relations and related travel expenses, and a recovery of
$48,000 in fiscal 2010 of previously recorded bad debt expense. G&A expenses of $2.6 million
during the nine months ended December 31, 2010, increased $408,000 from $2.2 million during the
same period in 2009. G&A expenses increased primarily because of a $137,000 increase in
compensation and bonus costs, a $156,000 increase in investors relations and related travel
expenses, a $29,000 increase in legal fees, and a recovery of $48,000 in fiscal 2010 of previously
recorded bad debt expense.
Research and Development Expenses (R&D): R&D expenses increased to $424,000 during the three
months ended December 31, 2010 from $401,000 during the same period in 2009. The increase is
attributed primarily to an increase in product design and regulatory expenses. R&D expenses
decreased to $1.3 million during the nine months ended December 31, 2010 from $1.4 million during
the same period in 2009. Included in the nine-month period ended December 31, 2010 is a $20,000
non-cash, share-based compensation expense, compared with a similar charge of $42,000 in the
nine-month period ended December 31, 2009. Excluding share-based compensation charges, R&D
expenses decreased by $47,000. The decrease is attributed primarily to a $131,000 decrease in
spending for clinical studies, offset partially by an increase of $28,000 in compensation and bonus
costs, and an increase of $53,000 in product design and regulatory costs. We expect to spend a
total of approximately $350,000 in fiscal 2011 for ongoing clinical studies to support marketing
efforts and to meet regulatory requirements.
Selling and Marketing Expenses (S&M): S&M expenses of $2.9 million during the three months ended
December 31, 2010, increased $1.2 million from $1.7 million during the same period in 2009. S&M
expenses during the three months ended December 31, 2010, increased primarily because of a $654,000
increase in compensation costs as a result of the increase in our U.S. field sales organization, an
increase in travel expense of $184,000, an increase in commission expenses of $125,000, an increase
in consulting expense of $101,000, and an increase of $76,000 related to marketing activities. S&M
expenses of $6.9 million during the nine months ended December 31, 2010, increased $1.2 million
from $5.7 million during the same period in 2009. S&M expenses during the nine months ended
December 31, 2010, increased primarily because of a $725,000 increase in compensation costs as a
result of the increase in our U.S. field sales organization, an increase in travel expense of
$226,000, and an increase in commission expenses of $226,000. In anticipation of increased
interest in our Urgent PC after the new CPT code is effective in January 2011, we expanded our U.S.
field sales and support organization in our third quarter. Accordingly, we incurred increased S&M
expenses during the third quarter and expect to incur increased expenses during the remaining three
months of our current fiscal year.
Amortization of Intangibles: Amortization of intangibles was $211,000 for the three months ended
December 31, 2010 and 2009, and was $633,000 and $635,000 for the nine months ended December 31,
2010 and 2009, 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 $21,000 and $12,000 for the three months ended December 31, 2010 and 2009, respectively, and
was $61,000 and $43,000 for the nine months ended December 31, 2010 and 2009, respectively.
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 gain of $1,000 and foreign currency exchange loss of $8,000
for the three months ended December 31, 2010 and 2009, respectively, and foreign currency exchange
gain of $13,000 and foreign currency exchange loss of $23,000 for the nine months ended December
31, 2010 and 2009, respectively.
Income Tax Expense: During the three months ended December 31, 2010 and 2009, we recorded income
tax expense of $9,000 and $6,000, respectively, and $28,000 and $29,000 for the nine months ended
December 31, 2010 and 2009, 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 these
measures to evaluate the overall operating performance of companies in our industry, including as a
means of comparing period-to-period results and as a means of evaluating our results with those of
other companies.
Our non-GAAP operating loss during the three months ended December 31, 2010 and 2009 was approximately
$1,059,000 and $42,000, respectively. Our non-GAAP operating loss during the nine months ended
December 31, 2010 and 2009 was approximately $2.2 million and $1.4 million, respectively.
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Three Months Ended |
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Nine Months Ended |
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December 31 |
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December 31 |
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2010 |
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2009 |
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2010 |
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2009 |
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Gross Profit |
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GAAP gross profit |
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$ |
2,887,501 |
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$ |
2,562,743 |
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$ |
8,062,658 |
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$ |
7,288,103 |
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% of sales |
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83 |
% |
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|
84 |
% |
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83 |
% |
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|
82 |
% |
Share-based compensation |
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|
4,184 |
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|
|
4,771 |
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|
12,851 |
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|
23,218 |
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Depreciation expense |
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|
12,007 |
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|
14,481 |
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43,470 |
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42,780 |
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Non-GAAP gross profit |
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2,903,692 |
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2,581,995 |
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8,118,979 |
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7,354,101 |
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Operating Expenses |
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GAAP operating expenses |
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4,367,491 |
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2,955,178 |
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|
11,415,209 |
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9,929,140 |
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Share-based compensation |
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135,947 |
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60,351 |
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|
275,971 |
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|
333,365 |
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Depreciation expense |
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|
57,745 |
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|
59,462 |
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172,407 |
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|
175,085 |
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Amortization expense |
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211,057 |
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211,189 |
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632,508 |
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634,505 |
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Non-GAAP operating expenses |
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3,962,742 |
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|
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2,624,176 |
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|
|
10,334,323 |
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|
8,786,185 |
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Operating Loss |
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GAAP operating loss |
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(1,479,990 |
) |
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(392,435 |
) |
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(3,352,551 |
) |
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(2,641,037 |
) |
Share-based compensation |
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|
140,131 |
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|
|
65,122 |
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|
|
288,822 |
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|
356,583 |
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Depreciation expense |
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|
69,752 |
|
|
|
73,943 |
|
|
|
215,877 |
|
|
|
217,865 |
|
Amortization expense |
|
|
211,057 |
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|
|
211,189 |
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|
|
632,508 |
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|
|
634,505 |
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|
|
|
|
Non-GAAP operating loss |
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|
($1,059,050 |
) |
|
|
($42,181 |
) |
|
|
($2,215,344 |
) |
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|
($1,432,084 |
) |
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Page 20
Liquidity and Capital Resources
Cash Flows.
At December 31, 2010, our cash and cash equivalents and short-term investments balances totaled
$14.8 million. Our long-term investments at December 31, 2010 were $6.0 million.
At December 31, 2010, we had working capital of approximately $15.0 million. For the nine months
ended December 31, 2010, we used $2.2 million of cash in operating activities, compared to $1.9
million of cash used in the same period a year ago. We attribute the increase in cash used in
operating activities primarily to the increase in the operating loss, an increase in inventories
and receivables due to the increase in sales, offset partially by an increase in accrued
liabilities, primarily related to accruals of compensation-related expenses.
For the nine months ended December 31, 2010, we used $129,000 in investing activities to purchase
property, plant and equipment compared with approximately $70,000 for the same period a year ago.
For the nine months ended December 31, 2010 we generated proceeds from financing activities of
approximately $17.4 million, consisting of approximately $14.9 million net proceeds from the
offering of our common stock and approximately $2.5 million from the exercise of warrants and
options. In July 2010, in a public offering of our common stock, we issued 4.6 million shares
(inclusive of the over-allotment exercised by the underwriters) at $3.50 per share, for gross
proceeds of $16.1 million, and net proceeds, after fees and expenses, of approximately $14.9
million. We anticipate using the proceeds to expand our U.S. sales and marketing organization to
support our Urgent PC business and for clinical studies, working capital and general corporate
purposes. In anticipation of increased interest in our Urgent PC after the new CPT code is
effective, we have already started to expand our U.S. field sales and support organization.
Sources of Liquidity.
Uroplasty BV, our subsidiary, has an agreement with Rabobank of The Netherlands for a 500,000
(approximately $663,000) credit line secured by our facility in Geleen, The Netherlands. The bank
charges interest on the loan at the rate of one percentage point over the Rabobank base interest
rate (4.250% base rate on December 31, 2010), subject to a minimum interest rate of 3.50% per
annum. We had no borrowings outstanding on this credit line at December 31, 2010.
We believe we have sufficient liquidity to meet our needs for beyond the next twelve months.
Although we have historically not generated cash from operations because we have yet to achieve
profitability, we anticipate that we will become profitable and generate excess cash from
operations prior to the full use of the current available cash and investments. To achieve this
however, 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 fail to meet our projections of profitability and cash flow, or determine to use cash for
matters we have not currently projected, we may need to again seek financing to meet our cash
needs. We cannot assure you that such financing, if needed, will be available to us on acceptable
terms, or at all.
Commitments and Contingencies.
We discuss our commitments and contingencies in our Annual Report on Form 10-K for the year ended
March 31, 2010. There have been no significant changes in our commitments for capital expenditure
and contractual obligations since March 31, 2010.
We expect to continue to incur costs for clinical studies to support our ongoing marketing efforts
and to meet regulatory requirements. We also expect to continue to incur significant expenses to
support our U.S. sales and marketing organization, and for regulatory activities.
Page 21
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, 2010 that have materially affected, or are reasonably likely to materially affect our
internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1A. RISK FACTORS
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, 2010.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None during the quarter ended December 31, 2010.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. (REMOVED AND RESERVED)
ITEM 5. OTHER INFORMATION
We issued our earnings release with respect to the quarter ended December 31, 2010 on January 27,
2011. A copy of that earnings release is furnished (but not filed) as an exhibit to this
Quarterly Report on Form 10-Q.
ITEM 6. EXHIBITS
Exhibits
31.1 Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
32.1 Certifications by the Chief Executive Officer and the Chief Financial Officer pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (this Exhibit is furnished pursuant to SEC rules,
but is deemed not filed)
99.1 Press Release dated January 27, 2011
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: January 27, 2011 |
By: |
/s/ DAVID B. KAYSEN
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David B. Kaysen |
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President and Chief Executive Officer |
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Date: January 27, 2011 |
By: |
/s/ MAHEDI A. JIWANI
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Mahedi A. Jiwani |
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Chief Financial Officer |
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Page 23