U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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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 Quarter ended December 31, 2006
OR
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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 number 001-33216
OCULUS INNOVATIVE SCIENCES, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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68-0423298 |
(State or other jurisdiction of
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(I.R.S Employer |
incorporation or organization)
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Identification No.) |
1129 N. McDowell Blvd.
Petaluma, CA 94954
(Address of principal executive offices) (Zip code)
Registrants telephone number, including area code (707) 782-0792
Indicate by check 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 filings requirements for the past 90 days. Yes o No þ
Indicate by check mark whether the registrant is a large accelerated filter, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer in Rule 12b-2 of the Exchange
Act (Check One):
Large Accelerated Filer o Accelerated Filer o Non-Accelerated Filer 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 February 21, 2007 the number of shares outstanding of the registrants Common Stock, $0.0001
par value, was 11,753,334.
OCULUS INNOVATIVE SCIENCES, INC.
Index
OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
PART I: FINANCIAL INFORMATION
Item 1. Financial Statements
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Pro Forma |
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December 31, |
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March 31, |
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December 31, |
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2006 |
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2006 |
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2006 |
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(unaudited) |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
2,520 |
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$ |
7,448 |
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$ |
27,202 |
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Accounts receivable, net |
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1,612 |
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|
1,076 |
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1,612 |
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Inventories |
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423 |
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317 |
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423 |
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Prepaid expenses and other current assets |
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550 |
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1,386 |
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550 |
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Total current assets |
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5,105 |
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10,227 |
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29,787 |
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Property and equipment, net |
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2,160 |
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1,940 |
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2,160 |
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Restricted cash |
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47 |
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44 |
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47 |
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Deferred offering costs |
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1,516 |
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478 |
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Debt issue costs, net |
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972 |
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972 |
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Total assets |
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$ |
9,800 |
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$ |
12,689 |
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$ |
32,966 |
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LIABILITIES |
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Current liabilities: |
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Accounts payable |
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$ |
2,003 |
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$ |
2,774 |
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$ |
2,003 |
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Accrued expenses and other current liabilities |
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1,246 |
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1,686 |
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1,791 |
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Dividends payable |
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484 |
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121 |
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484 |
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Current portion of long-term debt |
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5,630 |
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504 |
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5,630 |
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Current portion of capital lease obligations |
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16 |
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15 |
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16 |
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Total current liabilities |
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9,379 |
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5,100 |
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9,924 |
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Long-term debt, less current portion |
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2,425 |
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210 |
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2,425 |
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Capital lease obligations, less current portion |
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29 |
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41 |
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29 |
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Total liabilities |
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11,833 |
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5,351 |
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12,378 |
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Commitments and Contingencies |
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Stockholders Equity (Deficit) |
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Convertible preferred stock, $0.0001 par value; 30,000,000 shares authorized, |
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Series A 1,347,709 shares issued and outstanding at
December, 31, 2006 (unaudited) and March 31, 2006 |
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6,668 |
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6,668 |
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Series B 2,635,744 shares issued and outstanding at
December 31, 2006 (unaudited) and March 31, 2006 |
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43,722 |
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43,722 |
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Series C 193,045 shares issued and outstanding at
December 31, 2006 (unaudited) |
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2,903 |
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Common stock, $0.0001 par value; 100,000,000 shares authorized,
4,223,286 and 4,218,981 shares issued and outstanding
at December 31, 2006 (unaudited) and March 31, 2006,
respectively, and 11,753,334 shares issued and
outstanding pro forma at December 31, 2006
(unaudited) |
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3,408 |
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3,399 |
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2 |
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Additional paid-in capital |
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6,057 |
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4,644 |
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85,377 |
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Deferred compensation |
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(798 |
) |
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Accumulated
other comprehensive income (loss) |
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(636 |
) |
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3 |
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(636 |
) |
Accumulated deficit |
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(64,155 |
) |
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(50,300 |
) |
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(64,155 |
) |
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Total stockholders equity (deficit) |
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(2,033 |
) |
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7,338 |
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20,588 |
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Total liabilities and stockholders equity (deficit) |
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$ |
9,800 |
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$ |
12,689 |
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$ |
32,966 |
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See accompanying notes to condensed consolidated financial statements
3
OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated
Statements of Operations
(In thousands, except share and per share amounts)
(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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2006 |
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2005 |
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2006 |
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2005 |
|
Revenues |
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Product |
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$ |
801 |
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$ |
416 |
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$ |
2,742 |
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$ |
1,222 |
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Service |
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|
251 |
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|
165 |
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|
639 |
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|
440 |
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Total revenues |
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1,052 |
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581 |
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3,381 |
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1,662 |
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Cost of revenues |
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Product |
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542 |
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|
1,571 |
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|
|
1,584 |
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|
2,920 |
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Service |
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|
218 |
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|
259 |
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|
641 |
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|
757 |
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Total cost of revenues |
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|
760 |
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|
1,830 |
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|
2,225 |
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3,677 |
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Gross profit (loss) |
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292 |
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(1,249 |
) |
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1,156 |
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(2,015 |
) |
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Operating expenses |
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Research and development |
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795 |
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737 |
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2,390 |
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|
1,700 |
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Selling, general and administrative |
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4,614 |
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|
3,878 |
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12,480 |
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11,584 |
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Total operating expenses |
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5,409 |
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|
4,615 |
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|
14,870 |
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13,284 |
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Loss from operations |
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|
(5,117 |
) |
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|
(5,864 |
) |
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|
(13,714 |
) |
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|
(15,299 |
) |
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Interest expense |
|
|
(305 |
) |
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|
(17 |
) |
|
|
(565 |
) |
|
|
(120 |
) |
Interest income |
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|
30 |
|
|
|
103 |
|
|
|
130 |
|
|
|
172 |
|
Other income (expense), net |
|
|
565 |
|
|
|
111 |
|
|
|
657 |
|
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|
10 |
|
|
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Net loss from continuing operations |
|
|
(4,827 |
) |
|
|
(5,667 |
) |
|
|
(13,492 |
) |
|
|
(15,237 |
) |
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Loss from operations of discontinued business |
|
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(413 |
) |
|
|
|
|
|
|
(587 |
) |
|
|
|
|
|
|
|
|
|
|
|
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Net loss |
|
|
(4,827 |
) |
|
|
(6,080 |
) |
|
|
(13,492 |
) |
|
|
(15,824 |
) |
|
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|
|
|
|
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|
|
|
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|
|
|
|
|
|
Preferred stock dividends |
|
|
(121 |
) |
|
|
|
|
|
|
(363 |
) |
|
|
|
|
|
|
|
|
|
|
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|
|
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|
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|
Net loss available to common stockholders |
|
$ |
(4,948 |
) |
|
$ |
(6,080 |
) |
|
$ |
(13,855 |
) |
|
$ |
(15,824 |
) |
|
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Net loss per common share: basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
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Continuing operations |
|
$ |
(1.17 |
) |
|
$ |
(1.35 |
) |
|
$ |
(3.28 |
) |
|
$ |
(3.69 |
) |
Discontinued operations |
|
|
|
|
|
|
(0.10 |
) |
|
|
|
|
|
|
(0.14 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(1.17 |
) |
|
$ |
(1.45 |
) |
|
$ |
(3.28 |
) |
|
$ |
(3.83 |
) |
Weighted-average number of shares used in per common share calculations: |
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|
|
|
|
|
|
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|
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|
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Basic and diluted |
|
|
4,223 |
|
|
|
4,210 |
|
|
|
4,222 |
|
|
|
4,128 |
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Other comprehensive loss, net of tax |
|
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|
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|
|
|
|
|
|
|
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|
Net loss |
|
$ |
(4,827 |
) |
|
$ |
(6,080 |
) |
|
$ |
(13,492 |
) |
|
$ |
(15,284 |
) |
Foreign currency translation adjustments |
|
|
(496 |
) |
|
|
(144 |
) |
|
|
(639 |
) |
|
|
(122 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(5,323 |
) |
|
$ |
(6,224 |
) |
|
$ |
(14,131 |
) |
|
$ |
(15,406 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed consolidated financial statements
4
OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Statement of Stockholders Equity (Deficit)
(In thousands, except share amounts)
(unaudited)
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Accumu |
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Deferred |
|
|
lated |
|
|
|
|
|
|
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|
|
Convertible Preferred Stock |
|
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|
|
|
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Stock- |
|
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Other |
|
|
|
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|
|
|
|
|
Series A ($0.0001) |
|
|
Series B ($0.0001) |
|
|
Series C ($0.0001) |
|
|
Common Stock ($0.0001) |
|
|
Additional |
|
|
Based |
|
|
Compre- |
|
|
Accumu |
|
|
|
|
|
|
par value |
|
|
par value |
|
|
par value |
|
|
par value |
|
|
Paid in |
|
|
Compen- |
|
|
hensive |
|
|
lated |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Sation |
|
|
Income |
|
|
Deficit |
|
|
Total |
|
Balance, April 1, 2006 |
|
|
1,347,709 |
|
|
$ |
6,668 |
|
|
|
2,635,744 |
|
|
$ |
43,722 |
|
|
|
|
|
|
$ |
|
|
|
|
4,218,981 |
|
|
$ |
3,399 |
|
|
$ |
4,644 |
|
|
$ |
(798 |
) |
|
$ |
3 |
|
|
$ |
(50,300 |
) |
|
$ |
7,338 |
|
Amortization of
stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
156 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
156 |
|
Non-employee stock-based
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8 |
|
Stock-based compensation related to fair value adjustment of common warrants with service conditions |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
80 |
|
Amortization of fair value
of common warrants issued
to consultant |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29 |
|
Fair value of common
warrants issued in
settlement of litigation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
365 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
365 |
|
Issuance of common stock
in exchange for services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,750 |
|
|
|
|
|
|
|
43 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43 |
|
Issuance of
Series B warrants in connection
with line of credit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,046 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,046 |
|
Issuance of common stock
warrants in connection
with line of credit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
105 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
105 |
|
Issuance of common stock
in connections with
exercise of warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
555 |
|
|
|
9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9 |
|
Issuance of Series C
convertible preferred
stock, net of offering
costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
193,045 |
|
|
|
2,903 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,903 |
|
Employee stock-based
compensation expense
recognized under SFAS No.
123R, net of forfeitures |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
379 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
379 |
|
Dividend payable to Series
A preferred stockholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(363 |
) |
|
|
(363 |
) |
Reclassification of
deferred stock-based
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(798 |
) |
|
|
798 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(639) |
|
|
|
|
|
|
|
(639 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,492 |
) |
|
|
(13,492 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2006 |
|
|
1,347,709 |
|
|
$ |
6,668 |
|
|
|
2,635,744 |
|
|
$ |
43,722 |
|
|
|
193,045 |
|
|
$ |
2,903 |
|
|
|
4,223,286 |
|
|
$ |
3,408 |
|
|
$ |
6,057 |
|
|
$ |
|
|
|
$ |
(636 |
) |
|
$ |
(64,155 |
) |
|
$ |
(2,033 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes to condensed consolidated financial statements
5
OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(In thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
Net loss from continuing operations |
|
$ |
(13,492 |
) |
|
$ |
(15,237 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
498 |
|
|
|
482 |
|
Stock-based compensation |
|
|
1,060 |
|
|
|
491 |
|
Non-cash interest expense |
|
|
256 |
|
|
|
|
|
Unrealized foreign exchange (gain) loss |
|
|
(694 |
) |
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(500 |
) |
|
|
(442 |
) |
Inventories |
|
|
(84 |
) |
|
|
366 |
|
Prepaid expenses and other current assets |
|
|
839 |
|
|
|
(741 |
) |
Accounts payable |
|
|
(787 |
) |
|
|
1,312 |
|
Accrued expenses and other liabilities |
|
|
(461 |
) |
|
|
(1,088 |
) |
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(13,365 |
) |
|
|
(14,857 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(653 |
) |
|
|
(491 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(653 |
) |
|
|
(491 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Deferred offering costs |
|
|
(1,036 |
) |
|
|
(457 |
) |
Proceeds from issuance of common stock upon exercise of stock options and warrants |
|
|
10 |
|
|
|
298 |
|
Proceeds
from issuance of convertible preferred stock |
|
|
2,903 |
|
|
|
27,026 |
|
Debt issue costs |
|
|
(75 |
) |
|
|
|
|
Proceeds from issued debt |
|
|
8,381 |
|
|
|
79 |
|
Principal payments on debt |
|
|
(1,040 |
) |
|
|
(818 |
) |
Payments on capital lease obligations |
|
|
(12 |
) |
|
|
(16 |
) |
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
9,131 |
|
|
|
26,112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from discontinued operations |
|
|
|
|
|
|
|
|
Operating cash flows |
|
|
|
|
|
|
(587 |
) |
Investing cash flows |
|
|
|
|
|
|
(666 |
) |
|
|
|
|
|
|
|
Net cash used in discontinued operations |
|
|
|
|
|
|
(1,253 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate on cash and cash equivalents |
|
|
(41 |
) |
|
|
(122 |
) |
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
(4,928 |
) |
|
|
9,389 |
|
Cash and equivalents, beginning of period |
|
|
7,448 |
|
|
|
3,287 |
|
|
|
|
|
|
|
|
Cash and equivalents, end of period |
|
$ |
2,520 |
|
|
$ |
12,676 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
271 |
|
|
$ |
93 |
|
|
|
|
|
|
|
|
Conversion of note into Series A convertible preferred stock |
|
$ |
|
|
|
$ |
40 |
|
|
|
|
|
|
|
|
Fair value
of Series B and common stock warrants issued with debt |
|
$ |
1,151 |
|
|
$ |
|
|
|
|
|
|
|
|
|
See
accompanying notes to condensed consolidated financial statements
6
OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 1. Organization and Summary of Significant Accounting Policies
Organization
Oculus Innovative Sciences, Inc. (the Company) was incorporated under the laws of the State
of California in April 1999 and was reincorporated under the laws of the State of Delaware in
December 2006. The Companys principal office is located in Petaluma, California. The Company
develops, manufactures and markets a family of products intended to prevent and eliminate infection
in acute and chronic wounds. The Companys platform technology, Microcyn, is a non-irritating,
superoxidized water-based solution that is designed to eliminate a wide range of bacteria, viruses,
fungi and spores without promoting the development of resistant strains of pathogens. The Company
conducts its business worldwide, with significant operating subsidiaries in Europe and Mexico.
Delaware Reincorporation
On December 15, 2006, the Company merged into OIS Reincorporation Sub, Inc., a Delaware
corporation (the Delaware Company). Pursuant to the Merger Agreement, an amendment to the
certificate of incorporation was filed pursuant to which (i) each four shares of outstanding
Company common stock were converted into one share of the Delaware Companys common stock ($0.0001
par value), (ii) each four shares of the Companys outstanding Series A convertible preferred stock
were converted into one share of the Delaware Companys Series A convertible preferred stock
($0.0001 par value), (iii) each four shares of the Companys outstanding Series B convertible
preferred stock were converted into one share of the Delaware Companys Series B convertible
preferred stock ($0.0001 par value), and (iv) each four shares of the California Companys
outstanding Series C convertible preferred stock were converted into one share of the Delaware
Companys Series C convertible preferred stock ($0.0001 par value). In addition, all options,
warrants or rights to purchase shares of Company common stock or Company convertible preferred
stock outstanding immediately prior to the Reincorporation were converted into options, warrants or
rights to purchase an equivalent number of shares of the Delaware Companys common stock or
convertible preferred stock, as the case may be, and those securities will continue to vest upon
the same terms and conditions as existed immediately prior to the Reincorporation.
Incorporation of Oculus Japan
In October 2006, the Company incorporated Oculus Japan KK, a wholly owned subsidiary. The
Japanese subsidiary will primarily conduct research and development activities.
Oculus Japan is insignificant with respect to the Companys
condensed consolidated operating results for the three and nine months ended December 31, 2006.
Reverse Stock Split
On December 15, 2006, the Company effected a 1-for-4 reverse stock split of its common stock.
All common shares and per share amounts have been retroactively restated in the accompanying
condensed consolidated financial statements and notes for all periods presented.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements as of December 31, 2006
and for the three and nine months ended December 31, 2006 have been prepared on the same basis as
the annual audited financial statements. The unaudited condensed consolidated balance sheet as of
December 31, 2006 and condensed consolidated statements of operations for the three and nine months
ended December 31, 2006 and 2005 and the condensed consolidated
statement of stockholders equity (deficit) for the nine months ended
December 31, 2006 and the condensed consolidated statements of cash flows for the
nine months ended December 31, 2006 and 2005 are unaudited, but include all adjustments, consisting
only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the
financial position, operating results and cash flows for the periods presented. The results for the
three and nine months ended December 31, 2006 are not necessarily indicative of results to be
expected for the year ending March 31, 2007 or for any future interim period. The consolidated
balance sheet at March 31, 2006 has been derived from audited statements. However, it does not
include all of the information and notes required by accounting principles generally accepted in the United States for complete
consolidated financial statements. The accompanying condensed consolidated financial statements should be
read in conjunction with the consolidated financial statements and notes thereto included in the
Companys Registration Statement on Form S-1, as amended, which was declared effective by the
Securities and Exchange Commission on January 24, 2007.
7
Unaudited Pro Forma Information
The
unaudited pro forma information(i) gives effect to the automatic
conversion of all the Companys convertible preferred stock that
was outstanding at the time of its initial public offering into
4,176,498 shares of common stock on January 30, 2007, (ii) the net proceeds from the offering of $22.3 million
(after deducting underwriting discounts, commissions and non-accountable
expenses), (iii) the exercise of 328,550
shares of the underwriters over-allotment option on February 16, 2006, and the net proceeds from
the exercise of the over-allotment of $2.4 million (after deducting underwriting commissions and
non-accountable expenses), and (iv) $2.1 million of
deferred offering costs paid, or to be paid, presented as a reduction to additional paid-in capital.
Stock-Based Compensation
Prior to April 1, 2006, the Company accounted for stock-based employee compensation
arrangements in accordance with the provisions of APB No. 25, Accounting for Stock Issued to
Employees, and its related interpretations and applied the disclosure requirements of SFAS No.
148, Accounting for Stock-Based Compensation-Transition and Disclosure, an amendment of FASB
Statement No. 123. The Company used the minimum value method to measure the fair value of awards
issued prior to April 1, 2006 with respect to its application of the disclosure requirements under
SFAS 123.
The following table illustrates the effect on net loss as if the Company had applied the fair
value recognition provisions of SFAS 123 to stock-based compensation arrangements (in thousands,
except per share data):
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Nine Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2005 |
|
|
2005 |
|
Net loss available to common stockholders, as reported |
|
$ |
(6,080 |
) |
|
$ |
(15,824 |
) |
Add: Total stock-based employee
compensation expenses included in
net loss |
|
|
61 |
|
|
|
217 |
|
Deduct: Total stock-based employee
compensation determined
under the fair-value based method
for all awards |
|
|
(144 |
) |
|
|
(372 |
) |
|
|
|
|
|
|
|
Net loss available to common stockholders, pro forma |
|
$ |
(6,163 |
) |
|
$ |
(15,979 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted: |
|
|
|
|
|
|
|
|
As reported |
|
$ |
(1.45 |
) |
|
$ |
(3.83 |
) |
Pro forma |
|
$ |
(1.46 |
) |
|
$ |
(3.87 |
) |
Effective April 1, 2006, the Company adopted SFAS No. 123(R) Share Based Payment (SFAS
123(R)). This statement is a revision of SFAS Statement No. 123, and supersedes APB Opinion No.
25, and its related implementation guidance. SFAS 123(R) addresses all forms of share based payment
(SBP) awards including shares issued under employee stock purchase plans, stock options,
restricted stock and stock appreciation rights. Under SFAS 123(R), SBP awards result in a cost that
will be measured at fair value on the awards grant date, based on the estimated number of awards
that are expected to vest and will result in a charge to operations.
The Company had a choice of two attribution methods for allocating compensation costs
under SFAS 123(R): the straight-line method, which allocates expense on a straight-line basis
over the requisite service period of the last separately vesting portion of an award, or the
graded vesting attribution method, which allocates expense on a straight-line basis over the
requisite service period for each separately vesting portion of the award as if the award was, in
substance, multiple awards. The Company chose the former method and amortized the fair value of
each option on a straight-line basis over the requisite period of the last separately vesting
portion of each award.
8
Under SFAS 123(R), nonpublic entities, including those that become public entities after
June 15, 2005, that used the minimum value method of measuring equity share options and similar
instruments for either recognition or pro forma disclosure purposes under Statement 123 are
required to apply SFAS 123(R) prospectively to new awards and to awards modified, repurchased, or
cancelled after the date of adoption. In addition, SFAS 123(R), requires such entities to continue
accounting for any portion of awards outstanding at the date of initial application using the
accounting principles originally applied to those awards. Accordingly, stock-based compensation
expense relating to awards granted prior to April 1, 2006 that are expected to vest in periods
ending after April 1, 2006 are being recorded in accordance with the provisions of APB 25 and its
related interpretive guidance.
The Company has adopted the prospective method with respect to accounting for its transition
to SFAS 123(R). Accordingly, the Company recognized in salaries and related expense in the
condensed consolidated statement of operations $52,000 of stock-based compensation expense in the three months ended
December 31, 2006 and $156,000 in the nine months ended December 31, 2006, which represents the
intrinsic value amortization of options granted prior to April 1, 2006 that the Company is
continuing to account for using the recognition and measurement principles prescribed under APB 25.
The Company also recognized in salaries and related expense in the condensed consolidated statement
of operations $335,000 of stock-based compensation expense in the three months ended December 31,
2006 and $379,000 in the nine months ended December 31, 2006, which represents the amortization of
the fair value of options granted subsequent to adoption of SFAS 123(R). In the current fiscal year
the Company reclassified certain components of its stockholders equity section to reflect the
elimination of deferred compensation arising from unvested share-based compensation pursuant to the
requirements of Staff Accounting Bulletin No. 107, regarding Statement of Financial Accounting
Standards No. 123(R), Share-Based Payment. This deferred compensation was previously recorded as
an increase to additional paid-in capital with a corresponding reduction to stockholders equity
for such deferred compensation. This reclassification has no effect on net income or total
stockholders equity as previously reported. The Company will record an increase to additional
paid-in capital as the share-based payments vest.
Recent Accounting Pronouncements
The
Financial Accounting Standards Board (FASB) issued FASB Interpretation No. (FIN) 48, Accounting for Uncertainty in Income
Taxes, on July 13, 2006. The new rules will be effective for the Company in fiscal 2008. At this
time, the Company has not completed its review and assessment of the impact of the adoption of FIN
48.
In September 2006, the FASB issued SFAS No. 157, Accounting for Fair Value Measurements
(SFAS 157). SFAS 157 defines fair value, and establishes a framework for measuring fair value in
generally accepted accounting principles and expands disclosure about fair value measurements. SFAS
157 is effective for financial statements issued subsequent to November 15, 2007. The Company does
not expect the new standard to have any material impact on the Companys financial position,
results of operations or cash flows.
In September 2006, the Securities and Exchange Commission (SEC) issued Staff Accounting
Bulletin 108, Considering the Effects on Prior Year Misstatements when Quantifying Misstatements in
Current Year Financial Statements, (SAB 108). SAB 108 requires registrants to quantify errors
using both the income statement method (i.e. iron curtain method) and the rollover method and
requires adjustment if either method indicates a material error. If a correction in the current
year relating to prior year errors is material to the current year, then the prior year financial
information needs to be corrected. A correction to the prior year results that are not material to
those years, would not require a restatement process where prior financials would be amended. SAB
108 is effective for fiscal years ending after November 15, 2006. The Company does not anticipate
that SAB 108 will have a material effect on its financial position, results of operations or cash
flows.
Other accounting standards that have been issued or proposed by the FASB or other
standards-setting bodies that do not require adoption until a future date are not expected to have
a material impact on the consolidated financial statements upon adoption.
Net Loss per Share
The Company computes net loss per share in accordance with SFAS No. 128 Earnings Per
Share and has applied the guidance enumerated in Staff Accounting Bulletin No. 98 (SAB Topic 4D)
with respect to evaluating its issuances of equity securities during all periods presented.
9
Under SFAS No. 128, basic net loss per share is computed by dividing net loss per share
available to common stockholders by the weighted average number of common shares outstanding for
the period and excludes the effects of any potentially dilutive securities. Diluted earnings per
share, if presented, would include the dilution that would occur upon the exercise or conversion of
all potentially dilutive securities into common stock using the treasury stock and/or if
converted methods as applicable. The computation of basic loss per share excludes potentially
dilutive securities because their inclusion would be anti-dilutive.
In addition to the above, the SEC (under SAB Topic 4D) requires new registrants to
retroactively include the dilutive effect of common stock or potential common stock issued for
nominal consideration during all periods presented in its computation of basic earnings (loss) per
share and diluted earnings (loss) per share as if they were, in substance, recapitalizations. The
Company evaluated all of its issuances of equity securities and determined that it had no nominal
issuances of common stock or common stock equivalents to include in its computation of loss per
share for any of the periods presented.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Historical |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common stockholders |
|
$ |
(4,948 |
) |
|
$ |
(6,080 |
) |
|
$ |
(13,855 |
) |
|
$ |
(15,824 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding for
basic and diluted loss per common share |
|
|
4,223 |
|
|
|
4,210 |
|
|
|
4,222 |
|
|
|
4,128 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share |
|
$ |
(1.17 |
) |
|
$ |
(1.45 |
) |
|
$ |
(3.28 |
) |
|
$ |
(3.83 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Anti-dilutive securities not included in historical
basic and diluted net loss per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options to purchase common stock |
|
|
2,043 |
|
|
|
1,963 |
|
|
|
2,043 |
|
|
|
1,963 |
|
Warrants to purchase common stock |
|
|
1,060 |
|
|
|
517 |
|
|
|
1,060 |
|
|
|
517 |
|
Convertible preferred stock
(as if converted) |
|
|
4,153 |
|
|
|
3,965 |
|
|
|
4,045 |
|
|
|
3,383 |
|
Warrants to purchase convertible preferred stock
(as if converted) |
|
|
88 |
|
|
|
17 |
|
|
|
88 |
|
|
|
17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,344 |
|
|
|
6,462 |
|
|
|
7,236 |
|
|
|
5,880 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent to December 31, 2006, the Company issued common stock in connection with the
conversion of its convertible preferred stock to common stock at the close of its initial public
offering, sold common stock in its initial public offering, and sold common stock in connection
with its underwriters partial exercise of their over-allotment option. These transactions
resulted in significant additional dilution. Following is a roll-forward showing the effect of the
Companys common stock transactions from December 31, 2006 to February 21, 2007 (in thousands):
|
|
|
|
|
Common stock outstanding at December 31, 2006 |
|
|
4,223 |
|
Common stock issued upon conversion of convertible preferred stock |
|
|
4,176 |
|
Common stock
sold in initial public offering |
|
|
3,025 |
|
Common stock sold in connection with exercise of over-allotment option |
|
|
329 |
|
|
|
|
|
Common stock
outstanding February 21, 2007 |
|
|
11,753 |
|
|
|
|
|
10
Preferred Stock
The Company applies the guidance enumerated in SFAS No. 150 Accounting for Certain Financial
Instruments with Characteristics of both Liabilities and Equity and EITF Topic D-98
Classification and Measurement of Redeemable Securities, when determining the classification and
measurement of preferred stock. Preferred shares subject to mandatory redemption (if
any) are classified as liability instruments and are measured at fair value in accordance with SFAS
150. All other issuances of preferred stock are subject to the classification and
measurement principles of EITF Topic D-98. Accordingly the Company classifies redeemable preferred
shares (if any), which includes preferred shares that feature redemption rights that are either
within the control of the holder or subject to redemption upon the occurrence of uncertain events
not solely within the Companys control, as temporary equity. At all other times, the Company
classifies its preferred shares in stockholders equity.
The
Companys convertible preferred shares do not feature any redemption rights
within the control of the holders or conditional redemption features not within its control as of March 31, 2006 or December
31, 2006. Accordingly all issuances of convertible preferred stock are presented as a component of stockholders
equity (deficit).
Convertible Instruments
The Company evaluates and accounts for conversion options embedded in its convertible
instruments in accordance with SFAS No. 133 Accounting for Derivative Instruments and Hedging
Activities (SFAS 133) and EITF 00-19 Accounting for Derivative Financial Instruments Indexed
to, and Potentially Settled in, a Companys Own Stock (EITF 00-19).
SFAS 133 generally provides three criteria that, if met, require companies to bifurcate
conversion options from their host instruments and account for them as free standing derivative
financial instruments in accordance with EITF 00-19. These three criteria include circumstances in
which (a) the economic characteristics and risks of the embedded derivative instrument are not
clearly and closely related to the economic characteristics and risks of the host contract, (b) the
hybrid instrument that embodies both the embedded derivative instrument and the host contract is
not remeasured at fair value under otherwise applicable generally accepted accounting principles
with changes in fair value reported in earnings as they occur and (c) a separate instrument with
the same terms as the embedded derivative instrument would be considered a derivative instrument
subject to the requirements of SFAS 133. SFAS 133 and EITF 00-19 also provide an exception to this
rule when the host instrument is deemed to be conventional (as that term is described in the
implementation guidance to SFAS 133 and further clarified in EITF 05-2 The Meaning of
Conventional Convertible Debt Instrument in Issue No. 00-19).
The Company accounts for convertible instruments (when it has determined that the
embedded conversion options should not be bifurcated from their host instruments) in accordance
with the provisions of EITF 98-5 Accounting for Convertible Securities with Beneficial Conversion
Features, (EITF 98-5) and EITF 00-27 Application of EITF 98-5 to Certain Convertible
Instruments. Accordingly, the Company records when necessary discounts to convertible notes for
the intrinsic value of conversion options embedded in debt instruments based upon the differences
between the fair value of the underlying common stock at the commitment date of the note
transaction and the effective conversion price embedded in the note. Debt discounts under these
arrangements are amortized over the term of the related debt to their earliest date of redemption.
The Company also records when necessary deemed dividends for the intrinsic value of conversion
options embedded in preferred shares based upon the differences between the fair value of the
underlying common stock at the commitment date of the note transaction and the effective conversion
price embedded in the note.
The Company evaluated the conversion option embedded in its convertible instruments
during each of the reporting periods presented and has determined, in accordance with the
provisions of these statements, that it does not meet the criteria requiring bifurcation of these
instruments. Additionally, the Companys conversion options, if free standing, would not be
considered derivatives subject to accounting guidelines prescribed under SFAS 133.
The characteristics of common stock that is issuable upon a holders exercise of
conversion options embedded in the Companys convertible preferred shares are deemed to be clearly and closely
related to the characteristics of the preferred shares (as that term is clarified in paragraph 61 l of the implementation guidance included in
Appendix A of SFAS 133). The Company did not record deemed dividends during any of the periods
presented because the
effective conversion price of the convertible preferred shares exceeded the fair value of
the Company common stock at the respective dates of issuance.
11
Common Stock Purchase Warrants and Other Derivative Financial Instruments
The Company accounts for the issuance of common stock purchase warrants issued and other
free standing derivative financial instruments in accordance with the provisions of EITF 00-19.
Based on the provisions of EITF 00-19, the Company classifies as equity any contracts that (i)
require physical settlement or net-share settlement or (ii) gives the Company a choice of net-cash
settlement or settlement in its own shares (physical settlement or net-share settlement). The
Company classifies as assets or liabilities any contracts that (i) require net-cash settlement
(including a requirement to net cash settle the contract if an event occurs and if that event is
outside the control of the Company) or (ii) gives the counterparty a choice of net-cash settlement
or settlement in shares (physical settlement or net-share settlement).
Note 2. Liquidity and Financial Condition
The
Company incurred net losses available to common stockholders $13,855,000 for the nine months ended December 31, 2006. At
March 31, 2006 and December 31, 2006, the Companys accumulated deficit amounted to $50,300,000 and
$64,155,000, respectively.
Through March 31, 2006, the Company raised, net of offering costs, an aggregate of
$56,368,000 in various equity financing transactions that, together with the proceeds of certain
debt financing transactions, enabled it to sustain operations while attempting to execute its
business plan. The Company had $5,127,000 of working capital as of March 31, 2006 and a working
capital deficiency of $(4,274,000) as of December 31, 2006. In addition, in June 2006, the Company
entered into a $5,000,000 credit facility from which it drew $4,182,000, to fund its operations,
and invest in new equipment. In addition, on November 7, 2006, the Company entered into a $4.0
million loan agreement which becomes due and payable with accrued interest of $280,000 on November 7, 2007.
The Companys Board of Directors and stockholders approved an amendment to the Articles
of Incorporation (that became effective on August 28, 2006) to authorize the issuance of up to
875,000 shares of Series C convertible preferred stock. On
September 14, 2006 and October 20, 2006 the Company sold
an aggregate of 193,045 units, consisting of 193,045 shares of Series C convertible preferred stock and warrants to
purchase 38,604 shares of the Companys common stock, for gross
proceeds of $3,474,000 ($2,903,000
net of offering costs).
On January 30, 2007 the Company completed an initial public offering of 3,025,000 shares of
its common stock at $8.00 per share. Net proceeds from the offering, after deducting underwriting
discounts, commissions, and non-accountable expenses paid to the underwriters were $22.3 million.
On the closing of the Companys initial public offering on January 30, 2007, all of the convertible
preferred stock outstanding automatically converted into 4,176,498
shares of common stock (Note 10).
On
February 16, 2007 the underwriters of the Companys initial
public offering exercised part of their
over-allotment option and purchased 328,550 shares of the Companys
common stock resulting in net proceeds
of $2.4 million after deducting
underwriting discounts, commissions, and non-accountable expenses
(Note 10).
The
Company currently intends to use the proceeds of the initial public
offering to fund its sales and marketing activities, clinical
trials and related research. The remaining proceeds are to be used
for general corporate purposes including, working capital. The Company anticipates it will incur significant costs in connection with
Sarbanes-Oxley compliance and other costs associated with reporting as a public entity.
Management
believes that the Company, through the funds it raised in the initial public offering,
sale of over-allotment shares and funds it expects to generate from operations,
will have sufficient liquidity to sustain the business through December 31,
2007.
12
Note 3. Balance Sheet
Inventories
Inventories consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
|
|
2006 |
|
|
2006 |
|
Raw materials |
|
$ |
360 |
|
|
$ |
267 |
|
Finished goods |
|
|
130 |
|
|
|
1,046 |
|
|
|
|
|
|
|
|
|
|
|
490 |
|
|
|
1,313 |
|
Less: inventory allowances |
|
|
(67 |
) |
|
|
(996 |
) |
|
|
|
|
|
|
|
|
|
$ |
423 |
|
|
$ |
317 |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
Prepaid expenses and other current assets consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
|
|
2006 |
|
|
2006 |
|
Prepaid expenses |
|
$ |
308 |
|
|
$ |
304 |
|
Value added tax receivable |
|
|
164 |
|
|
|
722 |
|
Other current assets |
|
|
78 |
|
|
|
360 |
|
|
|
|
|
|
|
|
|
|
$ |
550 |
|
|
$ |
1,386 |
|
|
|
|
|
|
|
|
Debt Issue Costs
Debt
issue costs consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
2006 |
|
|
|
|
|
Fair value
of common stock purchase warrants issued to Brookstreet Securities
Corporation in connection with a Bridge Loan transaction |
|
$ |
1,046 |
|
|
|
|
|
Fair value
of preferred stock purchase warrants issued to Western Technologies,
Inc. in connection with a Line of Credit facility |
|
|
105 |
|
|
|
|
|
Cash paid
for debt offering expenses |
|
|
77 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,228 |
|
|
|
|
|
Less:
amortization recorded as non-cash interest expense |
|
|
(256 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
972 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
|
|
2006 |
|
|
2006 |
|
Accrued salaries |
|
$ |
418 |
|
|
|
267 |
|
Accrued professional fees |
|
|
203 |
|
|
|
673 |
|
Estimated liability for pending litigation |
|
|
250 |
|
|
|
300 |
|
Accrued value added tax payable |
|
|
|
|
|
|
220 |
|
Deferred revenue |
|
|
76 |
|
|
|
156 |
|
Accrued other |
|
|
299 |
|
|
|
70 |
|
|
|
|
|
|
|
|
|
|
$ |
1,246 |
|
|
$ |
1,686 |
|
|
|
|
|
|
|
|
Note 4. Notes Payable
In June 2006, the Company entered into a credit facility with a financial institution,
providing it with up to $5,000,000 of available credit. The facility permitted the Company to
borrow up to a maximum of $2,750,000 for growth capital, $1,250,000 for working capital based on
eligible accounts receivable and $1,000,000 in equipment financing. During the nine months ended
December 31, 2006, the Company drew an aggregate of $4,182,000 of borrowings under this facility.
These borrowings are payable in 30 to 33 fixed monthly installments with interest at
rates ranging from 12.4% to 12.7% per annum, maturing at various times through April 9, 2009.
13
The
Company also issued to the lender warrants to purchase up to 71,534 shares of its
Series B convertible preferred stock upon originating the loan. Upon closing of the Companys IPO
on January 30, 2006, the warrants to purchase Series B convertible preferred stock automatically
converted to warrants to purchase common stock. In addition, the Company will issue warrants to
purchase up to 3,466 additional shares of common stock if it makes additional draws on the line of
credit. The Companys ability to draw on the credit facility expires on March 31, 2007. The
aggregate fair value of all warrants issued to the lender under this arrangement amounted to
$1,046,000. This amount was recorded as debt issue costs and is being amortized as interest expense
over the term of the credit facility. In the three and nine months ended December 31, 2006, the
Company recorded non-cash interest expense related to the amortization of the debt issue costs of
$105,000 and $227,000, respectively.
Borrowings under the growth capital line are collateralized by the total assets of the
Company including the Companys intellectual property. The security interest may be removed from
the intellectual property under certain circumstances. Borrowings under the equipment line are
collateralized by the underlying assets funded, and borrowings under the working capital line are
collateralized by eligible accounts receivable. On a monthly basis, the Company must maintain a 1:1
ratio of borrowings under the working capital line to eligible accounts receivable. The Company has
30 days from each measurement date to either increase eligible accounts receivable or pay the
excess principal in the event that the ratio is less than 1:1. No restrictive covenants exist for
either the equipment line or the growth capital line. The Company
made $336,000 and $505,000 of principal
payments and paid $122,000 and $222,000 of interest on these notes
during the three and nine months ended December 31,
2006, respectively. The Company is not required to direct customer remittances to a lock box, nor does the credit
agreement provide for subjective acceleration of the loans. The aggregate remaining principal
balance under this facility amounted to $3,677,000, including $1,455,000 in the current portion of
long-term debt in the accompanying condensed consolidated balance sheet at December 31, 2006.
In June 2006, the Company entered into a note agreement for $69,000 with interest rate of
7.94% percent per annum. The proceeds of this note were used to purchase an automobile. This note
is payable in monthly installments of $1,200 through May 2012. The Company made principal payments
of $2,200 and $5,100 and interest payments of $1,400 and $3,300 in the
three and nine months ended December 31, 2006, respectively. The
remaining balance of this note amounted to $64,000 at
December 31, 2006, including $9,500 in the
current portion of long-term debt in the accompanying condensed consolidated balance sheet.
From July 2006 to September 2006, the Company entered into note agreements for $129,000 with
interest rates ranging from 9.6% to 9.7% percent per annum. The proceeds of these notes were used
to finance insurance premiums. These notes are payable in monthly installments of $11,400 through
June 2007. The Company made principal payments of $31,600 and
$72,000 and interest payments of $2,400 and $3,200 in the
three and nine months ended December 31, 2006, respectively. The remaining balance of these notes amounted to $57,000 at
December 31, 2006, and is included in the current portion of long-term debt in the accompanying
condensed consolidated balance sheet.
On November 7, 2006, the Company signed a loan agreement with Robert Burlingame, one of the
Companys directors, in the amount of $4,000,000, which was
received on November 10, 2006 and which
accrues interest at an annual rate of 7%. Concurrently, Mr. Burlingame became a consultant to the
Company under a two-year consulting agreement, and was appointed to fill a vacancy on the Companys
Board of Directors. The principal and all accrued interest under the loan agreement will become due
and payable in full with interest on November 10, 2007. The loan
is secured by all the Companys assets,
other than our intellectual property, but will be subordinate to the security interest held by our
secured lender. At the time the principal was advanced to the
Company, Brookstreet Securities Corporation, who acted as the agent
in this transaction, was paid a fee of $50,000 and was granted a warrant to purchase 25,000 shares
of the Companys common stock at an exercise price of $18.00 per share. The aggregate fair value
of all warrants issued to the lender under this arrangement amounts to $104,500. This amount in
addition to the $50,000 cash payment was recorded as debt issue costs in the December 31, 2006
condensed consolidated balance sheet and is being amortized as
interest expense over the term of the loan.
In the three and nine months ended December 31, 2006, the Company
recorded non-cash interest expense of $23,000 related to the
amortization of the debt issue costs. In the three and nine months
ended December 31, 2006, the Company recorded interest expense of
$39,000.
The $4,000,000 loan is included in the current portion of long-term debt in the accompanying
condensed consolidated balance sheet at December 31, 2006.
14
Note 5. Commitments and Contingencies
Legal Matters
In
April 2005, the Company was named as a defendant in an employment related matter under a complaint
filed by one of its former employees in the Superior Court of the
State of California, in the County
of Sonoma, in April 2005. The Company entered into a settlement agreement with the plaintiff in
November 2006, which provides for the payment of $250,000 and the issuance of a warrant to purchase
50,000 shares of the Companys common stock exercisable at $3.00 per share. The warrants, which are
non-forfeitable at the date of issuance, were recorded at fair value which resulted in expense of
$365,000. The expense was recorded in the three months ended December 31, 2006 in selling, general
and administrative expense. The issuance of the warrants was subject to the Company obtaining
appropriate waivers from the Companys convertible preferred stockholders which was obtained in December
2006. The cash payment was made in February 2007. Under the terms of the agreement, the
plaintiff has agreed to dismiss his claim and has waived any other previous claims against the
Company. A $300,000 reserve was established at March 31, 2006 based on the Companys best estimate
of the potential loss. The reserve was reduced to the cash liability of $250,000 at December 31,
2006 and is a component of accrued expenses and other current liabilities in the accompanying
condensed consolidated balance sheet.
In November 2005, the Company identified a possible criminal misappropriation of its
technology in Mexico, and it notified the Mexican Attorney Generals office. The Company believes
the Mexican Attorney General is currently conducting an investigation.
On March 14, 2006, the Company filed suit in the U.S. District Court for the Northern
District of California against Nofil Corporation and Naoshi Kono, Chief Executive Officer of Nofil,
for breach of contract, misappropriation of trade secrets and trademark infringement. The Company
believes that Nofil Corporation violated key terms of both an exclusive purchase agreement and
non-disclosure agreement by contacting and working with a potential competitor in Mexico. In the
complaint, the Company seeks damages of $3,500,000 and immediate injunctive relief. On February
13, 2007, the Company received the defendants answer and cross-complaint. The cross-complaint,
which alleges fraudulent inducement to enter contracts, breach of non-disclosure contract, trade
secret misappropriation, conversion and violation under civil RICO statutes by the Company, seeks
damages in excess of $4,500,000. The Company believes that the cross-complaint, and
allegations therein, are without merit. No trial date has been set.
The Company cannot predict the outcome of this matter nor can it estimate a
range of possible loss. While the Company does not anticipate that
the outcome of this matter is likely to result in a material loss,
there can be no assurance that such outcome will not have a material
adverse effect on the Companys financial condition or results
of operations.
The Company is currently a party in two trademark matters asserting confusion in
trademarks with respect to the Companys use of the name Microcyn60 in Mexico. Although the Company
believes that the nature and intended use of its products are different from those with the similar
names, it has agreed with one of the parties to stop using the name Microcyn60 by September 2007.
Although such plaintiff referred the matter to the Mexico Trademark Office, the Company is not
aware of a claim for monetary damages. Company management believes that the name change will
satisfy an assertion of confusion; however, Company management believes that the Company could
incur a possible loss of approximately $100,000 for the use of the name Microcyn60 during the
year following the date of settlement.
In June 2006, the Company received a written communication from the grantor of a license to an
earlier version of its technology indicating that such license was terminated due to an alleged
breach of the license agreement by the Company. The license agreement extends to the Companys use
of the technology in Japan only. While the Company does not believe that the grantors revocation
is valid under the terms of the license agreement and no legal claim has been threatened to date,
the Company cannot provide any assurance that the grantor will not take legal action to restrict
the Companys use of the technology in the licensed territory. While the Company management does
not anticipate that the outcome of this matter is likely to result in a material loss, there can be
no assurance that if the grantor pursues legal action, such legal action would not have a material
adverse effect on the Companys consolidated financial position or results of operations.
In August 2006, the Company received a show cause letter from the U.S. Environmental
Protection Agency (EPA), which stated that, in tests conducted by the EPA, Cidalcyn was found to
be ineffective in killing certain specified pathogens when used according to label directions.
Based on its results, the EPA strongly recommended that the Company immediately recall all Cidalcyn
distributed on and after September 28, 2005. Accordingly, the Company has commenced a voluntary
recall of Cidalcyn. Although the Company has not marketed Cidalcyn on a large commercial scale, it
has provided it in small quantities to numerous hospitals solely for use in product evaluation
exercises. In a second letter, the EPA stated it intended to file a civil administrative complaint
against the
15
Company for violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Under FIFRA, the EPA could assess civil penalties related to the sale and distribution of a
pesticide product not meeting the labels claims as a broad-spectrum hospital disinfectant. The
Company believes that such civil penalties could be up to $200,000. The Company does not believe this
issue will have a material impact on future operations. The amount of expense incurred with
regard to the recall of the product was not significant because the product was not
commercialized and the number of samples distributed was minimal. For these reasons, the Company has not established an accrual
for the product recall. The Company is currently in negotiation with the EPA and believes the
actual loss will not have a material impact on the Companys operating results.
In September 2006, a consulting firm in Mexico City contacted the Company threatening
legal action in Mexico, alleging breach of contract and claiming damages of $225,000. In December
2006, the Company entered into a settlement agreement with the consulting firm where the Company
paid $115,000 and their claim and waiver of any previous claims were dismissed.
The Company, on occasion, is involved in legal matters arising in the ordinary course of
its business. While management believes that such matters are currently insignificant, there can be
no assurance that matters arising in the ordinary course of business for which the Company is or
could become involved in litigation will not have a material adverse effect on its business,
financial condition or results of operations
Other Matters
On June 16, 2005, the Company entered into a series of agreements with Quimica Pasteur, or QP,
a Mexico-based company engaged in the business of distributing pharmaceutical products to hospitals
and health care entities owned or operated by the Mexican Ministry of Health. These agreements
provided, among other things, for QP to act as the Companys exclusive distributor of Microcyn to
the Mexican Ministry of Health for a period of three years. In
connection with these agreements, the Company was concurrently granted
an option to acquire
all except a minority share of the equity of QP directly
from its principals in exchange for 150,000 shares of common stock, contingent upon QPs attainment
of certain financial milestones. The Companys distribution and related agreements were cancelable
by the Company on thirty days notice without cause and included certain provisions to hold the
Company harmless from debts incurred by QP outside the scope of the distribution and related
agreements. The Company terminated these agreements on March 26, 2006 without having exercised the option.
Due to its liquidity circumstances, QP was unable to sustain operations without the
Companys subordinated financial and management support. Accordingly, QP was deemed to be a
variable interest entity in accordance with FIN 46(R) and its results were consolidated with the
Companys consolidated financial statements for the period of June 16, 2005 through March 26, 2006, the
effective termination date of the distribution and related agreement
without such option having been exercised.
Subsequent to having entered into the agreements with QP, the Company became aware of an
alleged tax avoidance scheme involving the principals of QP. The audit committee of the Companys
Board of Directors engaged an independent counsel, as well as tax counsel in Mexico to investigate
this matter. The audit committee of the Board of Directors was advised that QPs principals could
be liable for up to $7,000,000 of unpaid taxes; however, the Company is unlikely to have any loss
exposure with respect to this matter because the alleged tax omission occurred prior to the
Companys involvement with QP. The Company has not received any communications to date from Mexican
tax authorities with respect to this matter.
Based on an opinion of Mexico counsel, the Company management and the audit committee of
the Board of Directors do not believe that the Company is likely to experience any loss with
respect to this matter. However, there can be no assurance that the Mexican tax authorities will
not pursue this matter and, if pursued, that it would not result in a material loss to the Company.
16
Note 6. Stockholders Equity (Deficit)
Authorized Capital
The Company is authorized to issue up to 100,000,000 shares of common stock and
30,000,000 shares of preferred stock of which 1,375,000 shares have been designated as Series A
preferred stock, 2,805,555 shares have been designated as Series B preferred stock and 875,000
shares have been designated Series C preferred stock. The Company reincorporated in Delaware on
December 15, 2006 and had at December 31, 2006 common stock,
Series A convertible preferred stock, Series B convertible preferred stock and
Series C convertible preferred stock, each with a par value of $0.0001 per share.
Rights
of
Common Stock
Each share of common stock has the right to one vote. The holders of common stock are
entitled to dividends when funds are legally available and when and
if declared by the Board of Directors,
subject to the prior right of the Series A convertible preferred stockholders to cumulative dividends that
accrue beginning January 1, 2006.
Convertible Preferred Stock
On
September 14, 2006 and October 20, 2006, the Company issued in a private placement
transaction, an aggregate of 193,045 shares of its Series C convertible preferred stock for net
proceeds of $2,903,000 (gross proceeds of $3,474,000 less placement agent commissions and other
offering costs of $571,000).
The Series A convertible preferred stock is convertible into common stock at any time, at
the option of the holder at a conversion price of $6.00 per share. The Series B and Series C
convertible preferred stock is convertible into common stock at any time, at the option of the
holder, at a conversion price of $18.00 per share.
The conversion prices of the Series A, Series B and Series C convertible preferred stock is
subject to adjustment for stock splits, stock dividends, recapitalizations, dilutive issuances and
other anti-dilution provisions, including circumstances in which the Company, at its discretion,
issues equity securities or convertible instruments that feature prices lower than the conversion
prices specified in the Series A, B and C convertible preferred stock. The Series A, Series B and
Series C convertible preferred stock are also automatically convertible into shares of the
Companys common stock, at the then applicable conversion price, (i) in the event that the holders
of two-thirds of the outstanding shares of Series A, Series B and Series C convertible preferred
stock consent to such conversion; or (ii) upon the closing of a firm commitment underwritten public
offering of shares of common stock of the Company yielding aggregate proceeds of not less than $20
million (before deduction of underwriters commissions and expenses); or (iii) upon the Company
going public by means of a merger or acquisition which has a resultant market capitalization of
greater than $75 million.
The Company has reserved 5,055,555 shares of its common stock for issuance upon the
conversion of its convertible preferred stock.
Each share of Series A, Series B and Series C convertible preferred stock has voting
rights equal to an equivalent number of common shares into which it is convertible and votes
together as one class with common stock. The holders of the Series A convertible preferred stock
are entitled to receive cumulative dividends in preference to any dividend on the common stock at
the rate of 6% per annum on the initial investment amount which
commenced
January 1, 2006. The dividends are payable in cash or stock. Dividends
accrued but unpaid with respect to this feature amounted to $121,000 for both the three months
ended December 31, 2006 and $363,000 for the nine months ended December 31, 2006, and is presented
as an increase in net loss available to the common stockholders. The Company has the option of
paying the dividend in either common stock or cash. The holders of Series B convertible preferred
stock are entitled to receive non-cumulative dividends when and if declared by the Board. The
holders of Series C convertible preferred stock are entitled to non-cumulative dividends when and
if declared by the Board and only after the Series A convertible preferred stock have been paid all
accrued but unpaid dividends and any dividends declared by the Board and payable to the Series B
convertible preferred stock have been paid. The holders of Series A, Series B and Series C
convertible preferred stock are also entitled to participate pro rata in any dividends paid on the
common stock, if declared by the Board of Directors on an as converted basis.
In the event of any liquidation or winding up of the Company, the holders of the Series A
convertible preferred stock shall be entitled to participate in the ratable distribution of the
assets of the Company until the holders of the Series A convertible preferred stock have received a
per share amount equal to $12.00 plus any declared but unpaid dividends. The holders of Series B
convertible preferred stock are entitled to participate in the ratable distribution of the assets
of the Company after the holders of Series A convertible preferred stock have received a per share
amount equal to $12.00 and holders of Series B convertible preferred stock have received a per
share amount equal to
17
$22.50, plus any declared but unpaid dividends. The holders of Series C convertible preferred
stock are entitled to participate in the ratable distribution of the assets of the Company after
the holders of Series A convertible preferred stock have received a per share amount equal to
$12.00, Series B convertible preferred stock have received a per share amount equal to $22.50 and
Series C convertible preferred stock have received a per share amount equal to $22.50, plus any
declared but unpaid dividends. Thereafter, any remaining assets would be distributed ratably to the
holders of common stock until the common stockholders have received a per share amount equal to
$12.00. Any remaining assets of the Company thereafter would be distributed ratably to the Series A
convertible preferred stockholders, Series B convertible preferred stockholders, Series C
convertible preferred stockholders and to the common stockholders, on
an as if converted basis.
Liquidation events include (i) a final dissolution or winding up of the Companys affairs
requiring a liquidation of all classes of stock, (ii) a merger, consolidation or similar event
resulting in a more than 50% change in control, (iii) the sale of all or substantially all of the
Companys assets and (iv) the effectuation (at the Companys election) of any transaction or series
of transactions resulting in a more than 50% change in control.
Under the terms of Series A, Series B and Series C convertible preferred stock investors
rights agreements between the Company and its convertible preferred stockholders, any time after
six months following the Companys initial public offering holders of a specified percentage of
the Series A, Series B and Series C convertible preferred stock may request that the Company file
a registration statement covering the public sale of the underlying common stock under
the Securities Act of 1933, as amended (the 1933 Act) with limited rights to delay by the
Company. Those investors are also entitled to unlimited piggyback registration rights on all 1933
Act registrations of the Company (except for registrations relating to employee benefit plans on
Form S-8 and corporate reorganizations on Form S-4). The foregoing demand and piggyback
registration rights terminate on the earlier of (i) one year after the Companys initial public
offering or (ii) such time as Rule 144 or another similar exemption under the 1933 Act is available
for sale of all of an Investors shares during a three-month period without registration. The
investors rights agreement also places certain restrictions on the convertible preferred
stockholders from selling their shares and provides them with certain rights of first refusal,
co-sale and drag along and tag along rights for sales effectuated under certain circumstances.
The Company applies the classification and measurement principles enumerated in EITF
Topic D-98 with respect to accounting for its issuances of the Series A, Series B and Series C
convertible preferred stock. The Company is required, under California law, to obtain the approval
of its Board of Directors in order to effectuate a merger, consolidation or similar event resulting
in a more than 50% change in control or a sale of all or substantially all of its assets. The Board
of Directors is then required to submit proposals to enter into these types of transactions to its
stockholders for their approval by majority vote. The Companys convertible preferred stockholders
do not (i) have control of the Companys Board of Directors and (ii) currently do not have
sufficient voting rights to control a redemption of these shares by either of these events. In
addition the effectuation of any transaction or series of transactions resulting in a more than 50%
change in control of the Company can be made only by the Company at its own election. Based on
these provisions, the Company classified its Series A,
Series B and Series C convertible preferred shares in
stockholders equity (deficit) in the accompanying
condensed consolidated balance sheet at December 31, 2006 because the
liquidation events are deemed to be within the Companys control in accordance with the provisions
of EITF Topic D-98.
Also as described in Note 1, the Company evaluated the conversion options embedded in the
Series A, Series B and Series C convertible preferred
stock securities to determine (in accordance with SFAS 133 and EITF
00-19) whether they should be bifurcated from their host instruments and accounted for as separate
derivative financial instruments. The Company determined, in accordance with SFAS 133, that the
risks and rewards of the common shares underlying the conversion feature are clearly and closely
related to those of the host instrument. Accordingly the conversion features, which are not deemed
to be beneficial at the commitment dates of these financing transactions, are being accounted for
as embedded conversion options in accordance with EITF 98-5 and EITF 00-27.
The Company evaluates the Series A, Series B and Series C convertible preferred stock at
each reporting date for appropriate balance sheet classification.
At the close of the Companys initial public offering on January 30, 2007, all of the
outstanding shares of convertible preferred stock were converted into 4,176,498 shares of common
stock.
18
Stock Purchase Warrants Issued in Financing Transactions
In June 2006, the Company issued warrants to purchase 71,534 shares of Series B preferred stock at an
exercise price of $ 18.00 per share in connection with the new financing facility described in Note 9. The warrants
were valued using the Black-Scholes pricing model. Assumptions used were as follows: Fair value of the underlying
stock $18.00; risk-free interest rate 5.15% percent; contractual life of 11 years; dividend yield of 0%; and volatility
of 70%. The fair value of the warrants, which amounted to $1,047,000, was recorded as deferred debt issue costs and
is being amortized as interest expense over the term of the credit
facility. Amortization of the these costs amounted
to $125,000 and is included as a component of interest expense in the accompanying statement of operations for the
six months ended September 30, 2006.
In
September 2006, the Company issued a warrant to purchase 10,567 shares of common stock at an exercise
price of $18.00 per share to the placement agent of the Series C stock offering. The warrants were fully
exercisable at the date of issuance with no future performance obligations by the placement agent and expire
five years from the date of issuance.
In
September 2006, the Company issued warrants to purchase 16,907 shares of common stock at an exercise
price of $18.00 per share to investors in conjunction with the purchase of Series C stock units. The warrants require settlement in shares of the Companys common stock. The Company accounts for the issuance of common
stock purchase warrants issued in connection with sales of its Units in accordance with the provisions of EITF
00-19 Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Companys
Own Stock. Based on the provisions of EITF 00-19, the Company classified the warrants as equity. In
addition, the Company determined the preferred stock was issued with no effective beneficial conversion
feature and therefore it was not necessary to record a deemed dividend.
In
October 2006, the Company issued a warrant to purchase
13,560 shares of common stock at an exercise price of $18.00 per share to the placement agent of
the Series C convertible preferred stock offering. The warrants were fully exercisable at the date of issuance with no
future performance obligations by the placement agent and expire five years from the date of
issuance.
In
October 2006, the Company issued warrants to purchase
21,697 shares of common stock at an exercise price of $18.00 per share to investors in conjunction
with the purchase of Series C convertible preferred stock units. The Series C convertible
stock units consist of one warrant for every five shares of
Series C convertible preferred stock units
purchased. The warrants require settlement in shares of the Companys common stock. The Company
accounts for the issuance of common stock purchase warrants issued in connection with sales of its
units in accordance with the provisions of EITF 00-19 Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Companys Own Stock. Based on the provisions
of EITF 00-19, the Company classified the warrants as equity. In addition, the Company determined
the convertible preferred stock was issued with no effective beneficial conversion feature and
therefore it was not necessary to record a deemed dividend.
In November 2006, Brookstreet was granted a warrant to purchase 25,000 shares of the Companys
common stock at an exercise price of $18.00 per share in connection with a finders fee for the
Robert Burlingame Bridge Loan, which funded in November 2006 (Note 4). The warrants were valued
using the Black-Scholes pricing model. The fair value of the warrants, which amounted to $105,000,
was recorded as debt issue costs in the accompanying condensed
consolidated balance sheet as of
December 31, 2006 and will be amortized as interest expense over the term of the loan. The Company
amortized $16,000 of interest related to this note in the three months ended December 31, 2006.
Common Stock and Common Stock Purchase Warrants Issued to Non-Employees for Services
In June 2006, the Company issued 3,750 shares of common stock to a consultant in exchange for
services provided. The fair value of the underlying stock was valued at $11.28 per share. The
shares were fully vested and were non-forfeitable when issued with no future performance obligation
by the consultant. The aggregate fair value of the shares, which amounted to $43,000, was recorded
as a selling, general and administrative expense in the accompanying condensed consolidated
statement of operations for the nine months ended December 31, 2006.
In November 2006, the Company entered into a two-year consulting agreement with its new
director, Robert Burlingame. Under the terms of the agreement, the Company issued the director a
warrant to purchase 75,000 shares of the Companys common stock, exercisable at a price equal to
the Companys common stock in its initial public offering in consideration of corporate advisory
services. The warrants were fully exercisable and non-forfeitable at date of issuance. The
warrants were valued using the Black-Scholes option pricing model. Assumptions used were as follows: Fair
value of the underlying stock of $9.00, which represented the expected mid-point of the IPO at the
December 31, 2006 reporting date; risk-free interest rate of 4.70% percent; contractual life of 5
years; dividend yield of 0%; and volatility of 70%. The fair value of the warrants amounted to
$416,000. Following the guidance enumerated in Issue 2 of EITF 96-18, the Company will amortize
the fair value of the warrants over the two year term of the consulting agreement which is
consistent with its treatment of similar cash transactions. For the three months ended December
31, 2006, the amortized fair value of the warrants amounted to
$29,000 and was recorded as selling, general
and administrative expense in the accompanying condensed consolidated statements of operations.
In November 2006, the Company entered into a settlement agreement with a former director and
chief operating officer. Pursuant to the settlement agreement the plaintiff was provided a warrant
to purchase 50,000 shares of the Companys common stock at an exercise price of $3.00 per share.
The warrants are non-forfeitable at date of issuance. The warrants were valued using the
Black-Scholes option pricing model. Assumptions used were as follows: Fair value of the underlying stock
$9.00; risk-free interest rate 4.70% percent; contractual life of 5 years; dividend yield of 0%;
and volatility of 70%. The fair value of the warrants amounted to $365,000 and was
recorded as selling, general and administrative expense in the accompanying condensed
consolidated statement of operations for the three months ended December 31, 2006.
19
During
the three and nine months ended December 31, 2006, the Company
recorded expense of $10,000 and
$80,000, respectively, for the adjusted fair value of warrants with service conditions issued in
prior periods. During the three and nine months ended December 31, 2005, the Company recorded expense
of $33,000 and $114,000, respectively, for the adjusted fair value of warrants with service
conditions. The non-vested portion of the warrants were adjusted to fair value at December 31,
2006 using the Black Scholes option pricing model with the following weighted average assumptions: Fair
value of the underlying stock $9.00; risk-free interest rate 4.74% percent; contractual life of 5.7
years; dividend yield of 0%; and volatility of 70%.
Note 7. Stock Compensation
Reverse
Stock Split
On December 15, 2006, the Company effected a equity restructuring through a 1-for-4 reverse
stock split of its common stock. The Company split adjusted both the exercise price and number of
shares underlying its outstanding employee stock options in accordance with stock plan equity
restructuring provisions, which include adjustments for stock splits, contained in the
Companys stock option plans. The Company applied the guidance specified in paragraph 54 and the
related implementation guidance included in Appendix A of SFAS 123(R) to evaluate whether the
equity restructuring and modification of awards resulted in an increase in the fair value of such
awards and whether additional compensation cost should be recognized. In accordance with SFAS
123(R) awards that are modified in equity restructurings pursuant to existing anti-dilution
provisions generally do not result in the recognition of additional compensation cost. The Company
evaluated the effect of the reverse-split on the fair value of existing stock options before and
after the equity restructuring in accordance with the equity restructuring guidelines. As a
result, the Company determined that it is not required to record
additional stock-based compensation cost.
2006 Stock Plan
On November 7, 2006, the Board authorized and reserved 1,250,000 shares for issuance of
options that may be granted under the Companys 2006 Stock Incentive Plan (the 2006 Plan), which
was previously adopted by the Board of Directors in August 2006. On December 14, 2006 the
stockholders approved the Companys 2006 Plan which became effective at the close of the Companys
initial public offering.
The 2006 Plan provides for the granting of incentive stock options to employees and the
granting of nonstatutory stock options to employees, non-employee directors, advisors, and
consultants. The 2006 Plan also provides for grants of restricted stock, stock appreciation rights
and stock units awards to employees, non-employee directors, advisors and consultants.
In accordance with the 2006 Plan, the stated exercise price shall not be less than 100% and
85% of the estimated fair market value of common stock on the date of grant for ISOs and NSOs,
respectively, as determined by the Board of Directors at the date of grant. With respect to any 10%
stockholder, the exercise price of an ISO or NSO shall not be less than 110% of the estimated fair
market value per share on the date of grant.
Options issued under the 2006 Plan have a ten-year term and generally become exercisable
over a five-year period.
Shares subject to awards that expire unexercised or are forfeited or terminated will again
become available for issuance under the 2006 Plan. No participant in the 2006 Plan can receive
option grants, restricted shares, stock appreciation rights or stock units for more than 750,000
shares in the aggregate in any calendar year.
Stock-Based Compensation Before Adoption of SFAS No. 123(R)
As described in Note 1, prior to April 1, 2006, the Company accounted for stock-based employee
compensation arrangements in accordance with the provisions of APB No. 25, Accounting for Stock
Issued to Employees, and its related interpretations and applied the disclosure requirements of
SFAS No. 148. The Company used the minimum value method to measure the fair value of awards issued
prior to April 1, 2006 with respect to its application of the disclosure requirements under SFAS
123.
20
The Company recognized in salaries and related expense in the condensed consolidated statement
of operations $52,000 and $61,000 of stock-based compensation expense in the three months ended
December 31, 2006 and 2005, respectively, and $156,000 and $217,000 in the nine months ended
December 31, 2006, and 2005, respectively, which represents the intrinsic value amortization of
options granted prior to April 1, 2006 that the Company is continuing to account for using the
recognition and measurement principles prescribed under APB 25. At December 31, 2006, there was
$534,000 of unrecognized compensation cost related to options that the Company accounted for under
APB 25 through March 31, 2006. These costs are expected to be recognized over a weighted average
amortization period of 1.79 years.
In accordance with the provisions of SFAS No. 123, the fair value of each employee option
granted in reporting periods prior to the adoption of SFAS 123(R) was estimated on the date of
grant using the minimum value method with the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
December 31, 2005 |
|
December 31, 2005 |
Estimated life |
|
|
6 yrs |
|
|
6 yrs |
Risk-free interest rate |
|
|
4.28 |
% |
|
|
4.18 |
% |
Dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
The weighted-average estimated minimum values of options granted was $9.04 per share for the
three months ended December 31, 2005 and $12.68 per share for the nine months ended December 31,
2005.
Stock-Based Compensation After Adoption of SFAS 123(R)
As described in Note 1, effective April 1, 2006, the Company adopted SFAS No. 123(R),
Share-Based Payment, using the prospective transition method, which requires the measurement and
recognition of compensation expense for all share-based payment awards granted, modified and
settled to the Companys employees and directors after
April 1, 2006. The Companys condensed consolidated financial
statements as of and for the three and nine months ended December 31, 2006 reflect the impact of SFAS No.
123(R). In accordance with the prospective transition method, the
Companys consolidated financial statements
for prior periods have not been restated to reflect, and do not include, the impact of SFAS No.
123(R).
The effect of the change of recording stock-based compensation expense from the original
provisions of APB No. 25 to the provisions of SFAS
No. 123(R) is as follows (in thousands, except per share
amounts) (unaudited):
|
|
|
|
|
|
|
|
|
|
|
For Three |
|
|
For Nine |
|
|
|
Months Ended |
|
|
Months Ended |
|
|
|
December 31, 2006 |
|
|
December 31, 2006 |
|
Cost of revenues-service |
|
$ |
1 |
|
|
$ |
3 |
|
Selling, general and administrative |
|
|
334 |
|
|
|
376 |
|
|
|
|
|
|
|
|
Total stock-based compensation |
|
$ |
335 |
|
|
$ |
379 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect on basic and diluted net
loss per common share |
|
$ |
(0.08 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
No income tax benefit has been recognized relating to stock-based compensation expense and no
tax benefits have been realized from exercised stock options. The implementation of SFAS No. 123(R)
did not have an impact on cash flows from financing activities during the nine months ended
December 31, 2006.
21
The Company estimated the fair value of employee stock options using the Black-Scholes option
pricing model. The fair value of employee stock options is being amortized on a straight-line basis
over the requisite service period of the awards. The fair value of employee stock options was
estimated using the following weighted-average assumptions (unaudited):
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
Nine Months |
|
|
Ended |
|
Ended |
|
|
December 31, 2006 |
|
December 31, 2006 |
Expected life |
|
2 yrs |
|
5 yrs |
Risk-free interest rate |
|
|
4.70 |
% |
|
|
4.63 |
% |
Dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
Volatility |
|
|
70 |
% |
|
|
70 |
% |
The estimated expected life of stock options represents the average period the stock options
are expected to remain outstanding and is based on the expected term calculated using the approach
prescribed by SAB 107 for plain vanilla options. The Company used this approach as it did not
have sufficient historical information to develop reasonable expectations about future exercise
patterns and post-vesting employment termination behavior. The expected stock price volatility for
the Companys stock options for the nine months ended December 31, 2006 was determined by examining
the historical volatilities for industry peers and using an average of the historical volatilities
of the Companys industry peers as the Company did not have any trading history for the Companys
common stock. The Company will continue to analyze the historical stock price volatility and
expected term assumption as more historical data for the Companys common stock becomes available.
The risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was
consistent with the expected term of the Companys stock options. The expected dividend assumption
is based on the Companys history and expectation of dividend
payments.
In addition, SFAS No. 123(R) requires forfeitures to be estimated at the time of grant and
revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
Forfeitures were estimated based on historical experience. Prior to the adoption of SFAS No.
123(R), the Company accounted for forfeitures as they occurred.
A summary of all option activity as of December 31, 2006 and changes during the nine month
period ended December 31, 2006 is presented below (unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Weighted- |
|
|
Aggregate |
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Exercise |
|
|
Contractual |
|
|
Value |
|
Options |
|
(000) |
|
|
Price |
|
|
Term |
|
|
($000) |
|
Outstanding at April 1, 2006 |
|
|
1,969 |
|
|
$ |
4.22 |
|
|
|
|
|
|
|
|
|
Granted (unaudited) |
|
|
245 |
|
|
|
12.31 |
|
|
|
|
|
|
|
|
|
Forfeited or expired (unaudited) |
|
|
(171 |
) |
|
|
3.57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2006 (unaudited) |
|
|
2,043 |
|
|
|
5.25 |
|
|
|
7.02 |
|
|
$ |
9,209 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2006 (unaudited |
|
|
1,209 |
|
|
$ |
2.71 |
|
|
|
5.92 |
|
|
$ |
8,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value is calculated as the difference between the exercise price of
the underlying stock options and the fair value of the Companys common stock ($9.00) for stock
options that are in-the-money as of December 31, 2006.
During the three and nine months ended December 31, 2006, the Company granted stock
options to employees with a weighted-average grant date fair value of
$5.30 and $7.12 per share,
respectively. At December 31, 2006, there was unrecognized compensation costs of $1,229,000 related
to these stock options. The cost is expected to be recognized over a weighted-average amortization
period of 4.57 years.
During
the nine months ended December 31, 2006, the Company modified stock
options granted to employees and non-employees under share based
arrangements in connection with the reverse-stock split equity restructuring. As described previously, the Company was not required to record any
additional compensation in connection with the reverse-stock split. The
Company did not capitalize any cost
associated with stock-based compensation.
The Company issues new shares of common stock upon exercise of stock options.
22
Non-Employee Options
The Company believes that the fair value of the stock options issued to non-employees is
more reliably measurable than the fair value of the services received. The fair value of the stock
options granted was calculated using the Black-Scholes option-pricing model as prescribed by SFAS
No. 123(R) using the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
December 31, 2006 |
|
December 31, 2006 |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Estimated life |
|
7.67 yrs |
|
8.12 yrs |
|
8.31 yrs |
|
8.58 yrs |
Risk-free interest rate |
|
|
4.70 |
% |
|
|
4.45 |
% |
|
|
4.68 |
% |
|
|
4.11 |
% |
Dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
|
|
0.00 |
% |
|
|
0.00 |
% |
Volatility |
|
|
70.0 |
% |
|
|
70.0 |
% |
|
|
70.0 |
% |
|
|
70.0 |
% |
Stock-based compensation expense will fluctuate as the fair market value of the common stock
fluctuates. In connection with stock options granted to non-employees, the Company recorded
$(2,500) and $3,900 of stock-based compensation expense during the three months ended December 31,
2006 and 2005, respectively, and $7,700 and $26,000 for the nine months ended December 31, 2006 and
2005, respectively.
Note 8. Income Taxes
The Company experienced substantial ownership changes in connection with financing
transactions it completed through the year ended March 31, 2006. Accordingly, the Companys
utilization of its net operating loss and tax credit carryforwards against taxable income in future
periods, if any, is subject to substantial limitations under the Change in Ownership rules of
Section 382 of the Internal Revenue Code. The Company, after considering all available evidence,
fully reserved for these and its other deferred tax assets since it is more likely than not such
benefits will not be realized in future periods. The Company has incurred losses for both financial
reporting and income tax purposes for the three months and nine months ended December 31, 2006 and
anticipates it will incur such losses for the year ending March 31, 2007. Accordingly, the Company
is continuing to fully reserve for its deferred tax assets. The Company will continue to evaluate
its deferred tax assets to determine whether any changes in circumstances could affect the
realization of their future benefit. If it is determined in future periods that portions of the
Companys deferred income tax assets satisfy the realization standard of SFAS No. 109, the
valuation allowance will be reduced accordingly.
23
Note 9. Segment and Geographic Information
The Company is organized primarily on the basis of operating units which are segregated
by geography.
The following tables present information about reportable segments (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S |
|
Europe |
|
Mexico |
|
Total |
Three months ended December
31, 2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
$ |
51 |
|
|
$ |
91 |
|
|
$ |
659 |
|
|
$ |
801 |
|
Service revenues |
|
|
251 |
|
|
|
|
|
|
|
|
|
|
|
251 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
302 |
|
|
|
91 |
|
|
|
659 |
|
|
|
1,052 |
|
Depreciation expense |
|
|
95 |
|
|
|
56 |
|
|
|
21 |
|
|
|
172 |
|
Loss from operations |
|
|
(3,243 |
) |
|
|
(790 |
) |
|
|
(1,084 |
) |
|
|
(5,117 |
) |
Interest expense |
|
|
(305 |
) |
|
|
|
|
|
|
|
|
|
|
(305 |
) |
Interest income |
|
|
30 |
|
|
|
|
|
|
|
|
|
|
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S |
|
Europe |
|
Mexico |
|
Total |
Three months ended December
31, 2005: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
$ |
6 |
|
|
|
|
|
|
$ |
410 |
|
|
$ |
416 |
|
Service revenues |
|
|
165 |
|
|
|
|
|
|
|
|
|
|
|
165 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
171 |
|
|
|
|
|
|
|
410 |
|
|
|
581 |
|
Depreciation expense |
|
|
122 |
|
|
|
23 |
|
|
|
35 |
|
|
|
180 |
|
Loss from operations |
|
|
(3,164 |
) |
|
|
(563 |
) |
|
|
(2,137 |
) |
|
|
(5,864 |
) |
Interest expense |
|
|
(17 |
) |
|
|
|
|
|
|
|
|
|
|
(17 |
) |
Interest income |
|
|
103 |
|
|
|
|
|
|
|
|
|
|
|
103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S |
|
Europe |
|
Mexico |
|
Total |
Nine months ended December 31, 2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
$ |
106 |
|
|
$ |
920 |
|
|
$ |
1,716 |
|
|
$ |
2,742 |
|
Service revenues |
|
|
639 |
|
|
|
|
|
|
|
|
|
|
|
639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
745 |
|
|
|
920 |
|
|
|
1,716 |
|
|
|
3,381 |
|
Depreciation expense |
|
|
284 |
|
|
|
148 |
|
|
|
66 |
|
|
|
498 |
|
Loss from operations |
|
|
(8,990 |
) |
|
|
(959 |
) |
|
|
(3,765 |
) |
|
|
(13,714 |
) |
Interest expense |
|
|
(565 |
) |
|
|
|
|
|
|
|
|
|
|
(565 |
) |
Interest income |
|
|
130 |
|
|
|
|
|
|
|
|
|
|
|
130 |
|
24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S |
|
Europe |
|
Mexico |
|
Total |
Nine months ended December 31, 2005: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
$ |
94 |
|
|
$ |
64 |
|
|
$ |
1,064 |
|
|
$ |
1,222 |
|
Service revenues |
|
|
440 |
|
|
|
|
|
|
|
|
|
|
|
440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
534 |
|
|
|
64 |
|
|
|
1,064 |
|
|
|
1,662 |
|
Depreciation expense |
|
|
349 |
|
|
|
58 |
|
|
|
75 |
|
|
|
482 |
|
Loss from operations |
|
|
(8,684 |
) |
|
|
(1,476 |
) |
|
|
(5,139 |
) |
|
|
(15,299 |
) |
Interest expense |
|
|
(120 |
) |
|
|
|
|
|
|
|
|
|
|
(120 |
) |
Interest income |
|
|
172 |
|
|
|
|
|
|
|
|
|
|
|
172 |
|
For the three and nine months ended December 31, 2006, sales to a customer in India were
$24,000 and $604,000, respectively. These sales are reported as part of the Europe segment.
The
following table shows long-lived net asset balances by segment (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
December
31, 2006 |
|
March
31, 2006 |
U.S. |
|
$ |
886 |
|
|
$ |
930 |
|
Europe |
|
|
894 |
|
|
|
639 |
|
Mexico |
|
|
380 |
|
|
|
371 |
|
|
|
|
|
|
Total |
|
$ |
2,160 |
|
|
$ |
1,940 |
|
|
|
|
|
|
The
following table shows total net asset balances by segment (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
December
31, 2006 |
|
March
31, 2006 |
U.S. |
|
$ |
6,104 |
|
|
$ |
8,977 |
|
Europe |
|
|
1,726 |
|
|
|
1,652 |
|
Mexico |
|
|
1,970 |
|
|
|
2,060 |
|
|
|
|
|
|
Total |
|
$ |
9,800 |
|
|
$ |
12,689 |
|
|
|
|
|
|
Note 10. Subsequent Events
Initial Public Offering
The
Companys Registration Statement on Form S-1, Amendment No. 7, (File No. 333-135584) related to our initial
public offering was declared effective by the SEC on January 24, 2007. A total of 3,025,000 shares
of the Companys common stock were registered with the SEC. All of these shares were registered on the Companys
behalf. The offering commenced on January 25, 2007 and 3,025,000 shares of common stock offered
were sold on January 30, 2007 for an aggregate offering price of
$24.2 million through the managing
underwriters: Roth Capital Partners, Maxim LLC and Brookstreet Securities Corporation.
The Company paid to the underwriters underwriting discounts, commissions and non-accountable
expenses totaling $1.9 million in connection with the initial public offering. In addition, the
Company incurred or may incur additional expenses of approximately $2.8 million in connection with
the initial public offering, which when added to the underwriting discounts, commissions and
non-accountable expenses paid by the Company amounts to total expenses of $4.7 million. Thus the
net offering proceeds to the Company (after deducting underwriting discounts and commissions and
offering expenses) were approximately $19.5 million. No offering expenses were paid directly or
indirectly to any of the Companys directors or officers (or their associates), persons owning ten
percent (10%) or more of any class of the Companys equity securities or to any other affiliates.
All of the net proceeds from the initial public offering were received on January 30, 2007,
after the close of the quarter. All net proceeds have been invested in interest bearing,
investment-grade securities. The Company has used the net proceeds of the public offering primarily for
general corporate purposes. The Company intends to use the net proceeds from the initial public offering to
finance our sales and marketing capabilities, our clinical trials and related research, and for
general corporate purposes. The amounts and timing of our actual expenditures will depend upon
numerous factors, including our sales and marketing activities, status of our clinical trials and
related research and the amount of cash generated by the
Companys operations, if any.
Underwriter
Partial Exercise of Over-allotment Option
On February 16, 2007 the underwriters of the Companys initial public offering exercised a
portion of their over-allotment option and purchased 328,550 shares of the Companys common stock
in accordance with the terms of the underwriting agreement resulting
in gross proceeds of $2.6 million and net proceeds of $2.4
million after deducting underwriting discounts, commissions, and non-accountable expenses.
Underwriter Warrants
On January 30, 2007, under the terms of the Underwriting Agreement and in connection with the
closing of the Companys IPO, the Company issued to the underwriters warrants to purchase an
aggregate of 211,750 shares of common stock at an exercise price of $13.20. On February 16,
2007, under the terms of the Underwriting Agreement and in connection with the closing of the
exercise of a portion of the underwriters over-allotment option, the Company issued to the
underwriters warrants to purchase an aggregate of 22,998 shares of the common stock of the Company
at an exercise price of $13.20.
25
Cancellation and Reissuance of Warrants
As
described in Note 6, the Company issued to its new director a warrant to purchase 75,000 shares of
common stock at an exercise price of $9.00, which was equal to the midpoint of the then
assumed price per share of the Companys common stock in the
initial public offering. This warrant was cancelled in
January 2007 and a new warrant, having an exercise price of $8.00 per share, but otherwise having
terms identical to the original warrant, was issued to the consultant.
Stock Unit Grant to Officer
On
October 1, 2005, the Board authorized the grant to one of the
Companys officers at the closing of
our initial public offering of an option under the 2004 Stock Option Plan to purchase 60,000 shares
of the Companys common stock at an exercise price of $3.00 per share. Due to the Boards subsequent
decision not to grant additional options under the 2004 Stock Option Plan, the adoption by the
Board and approval by the stockholders of the Companys 2006 Stock Incentive Plan, and certain
regulatory developments, on February 15, 2007, in lieu of the award of an option, the Compensation
Committee authorized the award to the officer of 60,000 stock units. Each stock unit represents
the right to receive a share of the Companys common stock, in consideration of past services rendered and
the payment by the officer of $3.00 per share, upon the settlement of the stock unit on a fixed
date in the future. Half of the stock units, representing 30,000 shares, will be settled on
January 15, 2009 and the remaining 30,000 will be settled on January 15, 2010.
Commercial Agreement
In
February 2007, Oculus Innovative Sciences Netherlands B.V., and Dancohr Corporation B.V., a
manufacturer and wholesaler of cosmetics and salon equipment to beauty, manicure, pedicure and hair
dressing professionals, entered into an exclusive agreement for
Dancohr to distribute Courtin(TM)
super-oxidized solution (formulated with Oculus Microcyn Technology) in the U.K., The
Netherlands, and other European Union Member States. Under terms of the agreement, Dancohr will distribute
Oculus Microcyn Technology under the brand name Courtin to Dancohrs network of cosmetology
professionals. The terms of the agreement provide for minimum purchases by Dancohr of approximately
$10 million of Oculus product over the five-year term of the agreement with the majority of
payments to be made in the final three years of the agreement. The agreement provides Oculus the
right to terminate the contract if minimum purchase volumes are not met.
Series A Convertible Preferred Stock
Dividend Payment
On
February 15, 2007 the Board of Directors authorized payment of dividends
to the persons who were holders of the Series A
convertible preferred stock immediately prior to the close of the IPO.
The Company will issue 87,494 shares of common stock in payment of the
dividend. The Company previously accrued $484,000 related to this dividend which is included in
the accompanying condensed consolidated balance sheet at December 31, 2006.
Lawsuit served on QP
On February 7, 2007, the
Companys Mexico subsidiary served Quimica Pasteur, a former
distributor of the Companys products in Mexico, with a claim alleging breach of contract under a note made by QP.
A trial date has not yet been set.
Item 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and results of operations should be
read in conjunction with the condensed consolidated financial statements and notes to those
statements included elsewhere in this Quarterly Report on Form 10-Q as of December 31, 2006 and our
audited consolidated financial statements for the year ended March 31, 2006 included in our
Registration Statement on Form S-1, as amended, which
was declared effective by the Securities and Exchange Commission on
January 24, 2007.
This Report contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. When used in this Report, the words expects, anticipates,
intends, estimates, plans, projects, continue, ongoing, potential, expect,
predict, believe, intend, may, will,
26
should, could, would and similar expressions
are intended to identify forward-looking statements. These are statements that relate to future
periods and include statements about, but not limited to: the progress and timing of our
development programs and regulatory approvals for our products; the benefits and effectiveness of
our products; the development of protocols for clinical studies; enrollment in clinical studies;
the progress and timing of clinical trials and physician studies; our expectations related to the
use of our proceeds from our initial public offering; our ability to manufacture sufficient amounts
of our product candidates for clinical trials and products for commercialization activities; the
outcome of discussions with the FDA and other regulatory agencies; the content and timing of
submissions to, and decisions made by, the FDA and other regulatory agencies, including
demonstrating to the satisfaction of the FDA the safety and efficacy of our products; the ability
of our products to meet existing or future regulatory standards; the rate and causes of infection;
the accuracy of our estimates of the size and characteristics of the markets which may be addressed
by our products; our expectations and capabilities relating to the sales and marketing of our
current products and our product candidates; the execution of distribution agreements; the
expansion of our sales force and distribution network; the establishment of strategic partnerships
for the development or sale of products; the timing of commercializing our products; our ability to
protect our intellectual property and operate our business without infringing on the intellectual
property of others; our ability to continue to expand our intellectual property portfolio; our
expectations about the outcome of litigation and controversies with third parties; our ability to
attract and retain qualified directors, officers, employees and advisory board members; our
relationship with Quimica Pasteur; our ability to compete with other companies that are developing
or selling products that are competitive with our products; the ability of our products to become
the standard of care for controlling infection in chronic and acute wounds; our ability to expand
to and commercialize products in markets outside the wound care market; our estimates regarding
future operating performance, earnings and capital requirements; our expectations with respect to
our microbiology contract testing laboratory; our expectations relating to the concentration of our
revenue from international sales; and the impact of the Sarbanes-Oxley Act of 2002 and any future
changes in accounting regulations or practices in general with respect to public companies
Forward-looking statements are subject to risks and uncertainties that could cause actual
results to differ materially from those projected. These risks and uncertainties include, but are
not limited to, those risks discussed below, as well as our ability to develop and commercialize
new products; the risk of unanticipated delays in research and development efforts; the risk that
we may not obtain reimbursement for our existing test and any future products we may develop; the
risks and uncertainties associated with the regulation of our products by the U.S. Food and Drug
Administration; the ability to compete against third parties; our ability to obtain capital when
needed; our history of operating losses and the risks set forth under Risks Related to our
Business. These forward-looking statements speak only as of the date hereof. The Company expressly
disclaims any obligation or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change in the Companys expectations
with regard thereto or any change in events, conditions or circumstances on which any such
statement is based..
In the section of this report entitled Managements Discussion and Analysis of Financial
Condition and Results of OperationsFactors that May Affect Results, all references to Oculus,
we, us, or our mean Oculus Innovative Sciences, Inc.
Business Overview
We have developed and manufacture and market a family of products intended to help prevent and
treat infections in chronic and acute wounds. Infection is a serious potential complication in both
chronic and acute wounds, and controlling infection is a critical step in wound healing. Our
platform technology, called Microcyn, is an electrically charged, or super-oxidized water-based
solution, that is designed to treat a wide range of pathogens, including viruses, fungi, spores and
antibiotic resistant strains of bacteria such as Methicillin-resistant Staphylococcus aureus, or
MRSA, and Vancomycin-resistant Enterococcus, or VRE, in wounds.
Microcyn has received CE Mark approval for wound cleaning and reduction of microbial loads,
three U.S. FDA 510(k) clearances as a medical device in wound debridement, lubricating, moistening
and dressing. Microcyn has also been granted approvals for use as an antiseptic, disinfectant and
sterilant in Mexico, approval for use in cleaning and debriding in wound management in India, and
approval for moistening, irrigating, cleansing and debriding skin lesions in Canada. In addition,
our 510(k) product label states that our 510(k) product is non-irritating and non-sensitizing to
skin and eyes and no special handling precautions are required. We do not have the necessary
regulatory approvals to market Microcyn in the United States as a drug, nor do we have the
necessary regulatory clearance or approval to market Microcyn in the U.S. as a medical device for a
wound healing indication.
27
We believe that Microcyn may be the first topical product that is effective against a broad
range of bacteria and other infectious microbes without causing toxic side effects on, or
irritation of, healthy tissue. Unlike most antibiotics, including antibiotic resistant strains,
such as MRSA and VRE, we believe Microcyn does not target specific strains of bacteria, a practice
which has been shown to promote the development of resistant bacteria. In addition, our products
are shelf stable, require no special preparation and are easy to use.
We currently sell Microcyn in the United States through a small commercial team and through
one national and five regional distributors. In Europe, we have a small direct sales force and
exclusive distribution agreements with four distributors, all of which are experienced suppliers to
the wound care market. In Mexico, we sell through a dedicated contract sales force, including
salespeople, nurses and clinical support staff, and a network of distributors to both the public
and private sector. The Mexican Ministry of Health, which approves product selection and
procurement for government hospitals and healthcare institutions, has approved reimbursement for
Microcyn. In India we sell through a national distributor, and in Canada, we have entered into a
distribution agreement under which distribution will commence upon
required regulatory approvals. We are currently assessing our costs
and results in Mexico and the Netherlands. We intend to reduce our
work force in the Netherlands and we may decide to reduce our sales
force in Mexico.
Clinical testing we conducted in connection with our 510(k) submissions to the FDA, as well as
physician clinical studies, suggest that our 510(k) product may help reduce a wide range of
pathogens. These physician clinical studies suggest that our 510(k) product is easy to use and
complementary to most existing treatment methods in wound care. Physician clinical studies also
suggest that our 510(k) Microcyn product may shorten hospital stays, lower aggregate patient care
costs and, in certain cases, reduce the need for system-wide or, systemic, antibiotics. Physicians
in several countries have also conducted studies in which Microcyn was used to treat infection in a
variety of wounds, including hard-to-treat wounds such as diabetic ulcers and burns, and, in some
cases, reduced the need for systemic antibiotics. The clinical testing and the physician studies
described above were not intended to be rigorously designed or controlled clinical trials and, as
such, did not have all of the controls required for clinical trials used to support a new drug
application to the FDA.
In July 2006, we completed a controlled clinical trial for pre-operative skin preparation.
After completion of this trial, the FDA advised us that it is considering adopting new heightened
performance requirements for evaluating efficacy of products designed to be used in pre-operative
skin preparation such as ours. In discussions with the FDA, the FDA has not provided us with the
definitive timing for, or parameters of, any such new requirements, and has informally stated that
it is uncertain during what time frame it will be able to do so. We plan to continue our
discussions with the FDA regarding the possible timing and parameters of any new guidelines for
evaluating efficacy for pre-operative skin preparations. Depending on the ultimate position of the
FDA regarding the performance criteria for pre-operative skin preparations, we may reassess our
priorities, clinical timelines and schedules for pursuing a pre-operative skin preparation
indication or may decide not to pursue this indication.
We intend to conduct a pilot study in early 2007 to evaluate the effectiveness of Microcyn in
patients with open wounds. Following completion of the pilot study, we intend to establish a
protocol for a pivotal clinical trial in a similar patient population, which we intend to begin in
mid to late 2007. We anticipate this trial to last approximately 12 months. We anticipate this
clinical trial to be completed in late 2008.
We are also conducting laboratory and animal testing to assess potential applications for
Microcyn in several other markets, including respiratory, dermatology, dental and veterinary
markets. FDA or other governmental approvals may be required for any potential new products or new
indicators.
In the event we choose to pursue a partnering arrangement to commercialize products, we would
expect a larger portion of our revenues would be derived from
licensing as opposed to direct sales. We will be evaluating the use
of partners especially outside the U.S. to reduce the costs and to
accelerate commercialization of Microcyn.
We also operate a microbiology contract testing laboratory division that provides consulting
and laboratory services to companies that design and manufacture biomedical devices, as well as
testing on our products and potential products. Our testing laboratory complies with U.S. good
manufacturing practices and quality systems regulation. We are in the process of transitioning our
business away from providing laboratory services to others, as we continue to focus our efforts on
commercializing Microcyn.
We have incurred significant net losses since our inception and had an accumulated deficit of
$64.2 million as of December 31, 2006. We expect to incur significant expenses in the foreseeable
future as we seek to commercialize our products, and we cannot be sure that we will achieve
profitability.
28
Financial Operations Overview
Revenues
We derive our revenues from product sales and service arrangements. Product revenues are
generated from the sale of Microcyn to hospitals, medical centers, doctors, pharmacies,
distributors and strategic partners, and are generally recorded upon shipment following receipt of
a purchase order or upon obtaining proof of sell-through by a distributor. Historically, a
significant amount of our product sales have been in Mexico, and more recently in India as well.
Service revenues are derived from consulting and testing contracts. Service revenues are
generally recorded upon performance under the service contract. Revenues generated from testing
contracts are recorded upon completion of the test and when the final report is sent to the
customer. We have refocused our business efforts away from consulting and testing services toward
the commercialization of Microcyn. As a result, we expect service revenues to continue to
significantly decline in future periods.
Cost of Revenues
Cost of product revenues represents the costs associated with the manufacturing of our
products, including expenses for our various facilities which are fixed, and related personnel cost
and the cost of materials used to produce our products. Cost of service revenues consists primarily
of personnel related expenses and supplies.
Research and Development Expense
Research and development expenses consists of costs related to the research and development of
Microcyn and our manufacturing process, the development of new products and new delivery systems
for our products and to carry
out preclinical studies and clinical trials to obtain various regulatory approvals. Research
and development expense is expensed as incurred.
Selling, General and Administrative Expense
Selling, general and administrative expenses consists of personnel related costs, including
salaries and sales commissions, and education and promotional expenses associated with Microcyn and
costs related to administrative personnel and senior management. These expenses also include the
costs of educating physicians and other healthcare professionals regarding our products and
participating in industry conferences and seminars. Selling, general and administrative expenses
also includes travel costs, outside consulting services, legal and accounting fees and other
professional and administrative costs.
Long-lived Assets in Geographic Regions
Our long-lived assets are located in three countries: the United States, the Netherlands, and
Mexico. The following table shows our net long-lived asset balances by country (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
|
|
2006 |
|
|
2006 |
|
U.S. |
|
$ |
886 |
|
|
$ |
930 |
|
Mexico |
|
|
380 |
|
|
|
371 |
|
Europe |
|
|
894 |
|
|
|
639 |
|
|
|
|
|
|
|
|
Total |
|
$ |
2,160 |
|
|
$ |
1,940 |
|
|
|
|
|
|
|
|
Our international operations are subject to risks, including difficulties and costs of
staffing and managing operations in certain foreign countries and in collecting accounts
receivables on a timely basis or at all. We plan to continue to market and sale our products
internationally to respond to customer requirements and market opportunities. However, until a
payment history is established over time with customers in a new geography or region, the
likelihood of collecting receivables generated by such operations could be less than our
expectations. As a result, there is a greater risk that reserves set with respect to the collection
of such receivables may be inadequate.
29
Because of our international operations, we generate revenues in foreign currencies and
are subject to the effects of exchange rate fluctuations. We are also exposed to foreign currency
risk related to our intercompany receivables. Any appreciation or devaluation of the Euro or
Mexican Peso will result in a gain or loss to the condensed consolidated statements of operations.
Further, if the effective price of our products were to increase as a result of fluctuations in
foreign currency exchange rates, demand for our products could decline and adversely affect our
results of operations and financial condition.
In addition, changes in policies or laws of the United States or foreign governments resulting
in, among other things, changes in regulations and the approval process, higher taxation, currency
conversion limitations, restrictions on fund transfers or the expropriation of private enterprises,
could reduce the anticipated benefits of our international expansion.
Discontinued Operations
On June 16, 2005, we entered into a series of agreements with Quimica Pasteur, or QP, a
Mexico-based distributor of pharmaceutical products to hospitals and health care entities owned
and/or operated by the Mexican Ministry of Health, or MOH. These agreements provided, among other
things, for QP to act as our exclusive distributor of Microcyn to the MOH for a period of three
years.
In connection with these agreements, we were granted an option to acquire all except a
minority share of the equity of QP directly from its principals in exchange for 150,000 shares of
our common stock, contingent upon QPs attainment of certain financial milestones. Two of our
employees were appointed as officers of QP, which resulted in the establishment of financial
control of QP by our company under applicable accounting literature. In addition, due to its
liquidity circumstances, QP was unable to sustain operations without our financial and management
support. Accordingly, QP was deemed to be a variable interest entity in accordance with FIN 46(R)
and the results of QP were therefore consolidated with our consolidated financial statements for
the period from June 16, 2005 through March 26, 2006, the effective termination date of the
distribution and related agreements.
In connection with an audit of QPs financial statements in late 2005, we were made aware of a
number of facts that suggested that QP or its principals may have engaged in some form of
fraudulent tax avoidance practice prior to the execution of the agreements between our company and
QP. We did not discover these facts prior to our execution of these agreements or for several
months thereafter. Our prior independent auditors informed us that we did not have effective
anti-fraud programs designed to detect the activities in which QPs principals engaged or the
personnel to effectively evaluate and determine the accounting for non-routine or complex
accounting transactions. Our audit committee engaged an outside law firm to conduct an
investigation whose findings implicated QPs principals in a systemic tax avoidance practice prior
to June 16, 2005. Based on the results of this investigation, we terminated our agreements with QP
on March 26, 2006. We estimate that QPs liability for taxes, interest and penalties related to
these practices could amount to $7 million or more. QP had a well-established relationship with the
MOH. Although we lost the benefit of this relationship when we terminated our agreements with QP,
we continue to sell to the MOH through our dedicated direct sales force and through other
distributors. As of December 31, 2006, our sales to the MOH were not negatively affected by the
termination of our relationship with QP and we do not expect that it will have a significant effect
on sales to the MOH in the future.
In accordance with SFAS 144, we have reported QPs results for the period of June 16, 2005
through March 26, 2006 as discontinued operations because the operations and cash flows of QP have
been eliminated from our ongoing operations as a result of the termination of these agreements. We
no longer have any continuing involvement with QP as of the date on which the agreements were
terminated. Amounts associated with the loss upon the termination of the agreements with QP, which
consisted of funds we advanced to QP to provide it with working capital, are presented separately
from our operating results.
Critical Accounting Policies
The preparation of our consolidated financial statements in conformity with United States
generally accepted accounting principles requires management to exercise its judgment. We exercise
considerable judgment with respect to establishing sound accounting polices and in making estimates
and assumptions that affect the reported
amounts of our assets and liabilities, our recognition of revenues and expenses, and
disclosure of commitments and contingencies at the date of the consolidated financial statements.
On an ongoing basis, we evaluate our estimates and judgments. Areas in which we exercise
significant judgment include, but are not necessarily limited to, our valuation of accounts
receivable, inventories, depreciation, amortization, recoverability of long-lived assets, income
30
taxes, equity transactions (compensatory and financing) and contingencies. We have also adopted
certain polices with respect to our recognition of revenue that we believe are consistent with the
guidance provided under Securities and Exchange Commission Staff Accounting Bulletin No. 104.
We base our estimates and judgments on a variety of factors including our historical
experience, knowledge of our business and industry, current and expected economic conditions, the
attributes of our products, regulatory environment, and in certain cases, the results of outside
appraisals. We periodically re-evaluate our estimates and assumptions with respect to these
judgments and modify our approach when circumstances indicate that modifications are necessary.
While we believe that the factors we evaluate provide us with a meaningful basis for
establishing and applying sound accounting policies, we cannot guarantee that the results will
always be accurate. Since the determination of these estimates requires the exercise of judgment,
actual results could differ from such estimates.
Descriptions of significant accounting policies that require us to make estimates and
assumptions in the preparation of our consolidated financial statements are as follows:
Revenue Recognition and Accounts Receivable
We generate product revenues from sales of our products to hospitals, medical centers,
doctors, pharmacies, distributors and strategic partners. We sell our products directly to third
parties and to distributors through various cancelable distribution agreements. We have also
entered into an agreement to license our products.
We apply the revenue recognition principles set forth in Securities and Exchange Commission
Staff Accounting Bulletin, or SAB, 104 Revenue Recognition, with respect to all of our revenues.
Accordingly, we record revenues when persuasive evidence of an arrangement exists, delivery has
occurred, the fee is fixed or determinable, and collectability of the sale is reasonable assured.
We require all of our product sales to be supported by evidence of a sale transaction that
clearly indicates the selling price to the customer, shipping terms and payment terms. Evidence of
an arrangement generally consists of a contract or purchase order approved by the customer. We have
ongoing relationships with certain customers from which we customarily accept orders by telephone
in lieu of a purchase order.
We recognize revenues at the time in which we receive a confirmation that the goods were
either tendered at their destination when shipped FOB destination, or transferred to a shipping
agent when shipped FOB shipping point. Delivery to the customer is deemed to have occurred when
the customer takes title to the product. Generally, title passes to the customer upon shipment, but
could occur when the customer receives the product based on the terms of the agreement with the
customer.
While we have a policy of investigating the creditworthiness of our customers, we have, under
certain circumstances, shipped goods in the past and deferred the recognition of revenues when
available information indicates that collection is in doubt. We establish allowances for doubtful
accounts when available information causes us to believe that a credit loss is probable.
We market a substantial portion of our goods through distributors. In Europe, we defer
recognition of distributor-generated revenues until the time we confirm that distributors have sold
these goods. Although our terms provide for no right of return, our products have a finite shelf
life and we may, at our discretion, accommodate distributors by accepting returns to avoid the
distribution of expired goods.
Service revenues are recorded upon performance of the service contracts. Revenues generated
from testing contracts are recorded when the test is completed and the final report is sent to the
customer.
Inventories and Cost of Revenues
We
state our inventories at the lower of cost, determined using the first-in, first-out method,
or market, based on standard costs. Establishing standard manufacturing costs requires us to make
estimates and assumptions as to the
quantities and costs of materials, labor and overhead that are required to produce a finished
good. Cost of service revenues is expensed when incurred.
31
Income Taxes
We are required to determine the aggregate amount of income tax expense or loss based upon tax
statutes in jurisdictions in which we conduct business. In making these estimates, we adjust our
results determined in accordance with United States generally accepted accounting principles for items that are
treated differently by the applicable taxing authorities. Deferred tax assets and liabilities, as a
result of these differences, are reflected on our consolidated balance sheet for temporary
differences in loss and credit carryforwards that will reverse in subsequent years. We also
establish a valuation allowance against deferred tax assets when it is more likely than not that
some or all of the deferred tax assets will not be realized. Valuation allowances are based, in
part, on predictions that management must make as to our results in future periods. The outcome of
events could differ over time which would require that we make changes in our valuation allowance.
Equity Transactions
Under United States generally accepted accounting principles, we have the ability to choose
between two alternative methods of accounting for employee stock-based compensation: the intrinsic
value method or the fair value method. Although we have adopted the intrinsic value method, the
results we could derive under the fair value method could differ significantly. In addition, since
our common stock was not publicly traded through December 31,
2006 , we must estimated its fair value. We have used outside valuation
specialists that have relied upon information provided by management to determine value of our
common stock and have also made valuation estimates based on concurrent sales of equity securities for
cash and other business related information.
Stock-Based Compensation Expense
Prior to April 1, 2006, we accounted for stock-based employee compensation arrangements in
accordance with the provisions of Accounting Principles Board Opinion No. 25, or APB No. 25,
Accounting for Stock Issued to Employees, and its interpretations and applied the disclosure
requirements of SFAS No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure,
an amendment of FASB Statement No. 123. We used the minimum value method to measure the fair value
of awards issued prior to April 1, 2006 with respect to its application requirements under SFAS No.
123.
Effective April 1, 2006, we adopted SFAS No. 123(R) Share Based Payment, or SFAS 123(R).
This statement is a revision of SFAS Statement No. 123, Accounting for Stock-Based Compensation
and supersedes APB Opinion No. 25, and its related implementation guidance. SFAS 123(R) addresses
all forms of share-based payment, or SBP, awards including shares issued under employee stock
purchase plans, stock options, restricted stock and stock appreciation rights. Under SFAS 123(R),
SBP awards result in a cost that will be measured at fair value on the awards grant date, based on
the estimated number of awards that are expected to vest and will result in a charge to operations.
Under SFAS 123(R), nonpublic entities, including those that become public entities after June
15, 2005, that used the minimum value method of measuring equity share options and similar
instruments for either recognition or pro forma disclosure purposes under Statement 123 are
required to apply SFAS 123(R) prospectively to new awards and to awards modified, repurchased or
cancelled after the date of adoption. In addition, SFAS 123(R) requires such entities to continue
accounting for any portion of awards outstanding at the date of initial application using the
accounting principles originally applied to those awards. Accordingly, we record stock-based
compensation expense relating to awards granted prior to April 1, 2006 that are expected to vest in
periods ended after April 1, 2006 in accordance with the provisions of APB No. 25 and related
interpretive guidance.
We have adopted the prospective method with respect to accounting for its transition to SFAS
123(R). Accordingly, we recognized in salaries and related expense in the condensed consolidated
statement of operations $52,000 of stock-based compensation expense in the three months ended
December 31, 2006 and $156,000 in the nine months ended December 31, 2006, which represents the
intrinsic value amortization of options granted prior to April 1, 2006 that the we are continuing
to account for using the recognition and measurement principles prescribed under APB 25. We also
recognized in salaries and related expense in the condensed consolidated statement of operations
$336,000 of stock-based compensation expense in the three months ended December 31, 2006 and
$378,000 in the nine months ended December 31, 2006, which represents the amortization of the fair
value of
options granted subsequent to adoption of SFAS 123(R). In the current fiscal year we have
reclassified certain components of our stockholders equity section to reflect the elimination of
deferred compensation arising from unvested share-based compensation pursuant to the requirements
of Staff Accounting Bulletin No. 107, regarding Statement of Financial Accounting Standards No.
123(R), Share-Based Payment. This deferred compensation was previously recorded as an increase to
additional paid-in capital with a corresponding reduction to stockholders equity for such deferred
compensation. This reclassification has no effect on net loss or total stockholders equity
32
as
previously reported. We will record an increase to additional paid-in capital and a compensation
charge as the share-based payments vest.
The following table shows our non-cash stock-based compensation expenses as booked in our
condensed consolidated statements of operations (in thousandss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Cost of revenues |
|
$ |
1 |
|
|
$ |
1 |
|
|
$ |
2 |
|
|
$ |
2 |
|
Research and development |
|
|
20 |
|
|
|
20 |
|
|
|
61 |
|
|
|
32 |
|
Selling, general and administrative |
|
|
769 |
|
|
|
204 |
|
|
|
997 |
|
|
|
457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
790 |
|
|
$ |
225 |
|
|
$ |
1,060 |
|
|
$ |
491 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparison of Three Months Ended December 31, 2006 and 2005
Revenues
Revenues increased $471,000 or 81%, to $1.1 million for the three months ended December 31,
2006, from $581,000 for the three months ended December 31, 2005. During the three months ended
December 31, 2006, product revenues were $801,000 and service revenues were $251,000. During the
three months ended December 31, 2005, product revenues were $416,000 and service revenues were
$165,000. The $385,000, or 93%, increase in product revenues was primarily due to the penetration
by our direct sales forces into hospital and pharmacy markets, primarily in Mexico.
The following table shows our product revenues by country (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
U.S. |
|
$ |
51 |
|
|
$ |
6 |
|
Mexico |
|
|
659 |
|
|
|
410 |
|
India |
|
|
24 |
|
|
|
|
|
Europe |
|
|
67 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
801 |
|
|
$ |
416 |
|
|
|
|
|
|
|
|
Cost of Revenues
Cost of revenues decreased $1.1 million, or 58%, to $760,000 for the three months ended
December 31, 2006, from $1.8 million for the three months ended December 31, 2005. During the
three months ended December 31, 2006, cost of revenues from product sales were $542,000 and cost of
revenues from services were $218,000. During the three months ended December 31, 2005, cost of
revenues from product sales were $1.6 million and cost of revenues from services were $259,000.
Cost of revenues from product sales decreased $1.0 million, or 65%, for the three months ended
December 31, 2006 as compared to the three months ended December 31, 2005. Cost of revenues from
product sales in the United States decreased $179,000 due to the shifting of focus in our United
States facility from manufacturing to activities related to the research and development of new
Microcyn products. As a result, we began classifying the expense associated with our United States
facility as a research and development expense, and therefore our fixed cost of
33
product revenues
decreased accordingly. Cost of revenues from product sales in Europe
stayed relatively consistent from period to period. Cost of revenues from
product sales in Mexico decreased $828,000 primarily due to the
$922,000 write-off of inventory, during the three months ended
December 31, 2005, due to product labeling issues and expiring
shelf life of products as a result of a one-time build-up of excess
product inventory.
Our gross margin
increased to a profit of $292,000, or 28% of revenues, for the three months
ended December 31, 2006, from a gross loss of $1.2 million
for the three months ended December 31,
2005. Our gross margins from product sales increased to a gross profit of $259,000, or 32% of
product revenues, for the three months ended December 31, 2006, from a gross loss from product
sales of $1.2 million for the three months ended December 31, 2005. Primarily this improvement in
our margins was due to the decrease in our fixed cost of product manufacturing, primarily in
Mexico, while our product revenues increased over the same period.
We
experienced gross margins of 28% during the three months ended December 31, 2006, and
expect to experience positive gross margins in future periods as well. If we fail to increase our
sales volume to sufficient levels in the future, we may have to examine strategies to reduce our
recurring fixed costs of manufacturing. We expect that cost of revenues will continue to increase
in absolute dollars as product sales increase in future periods.
Research
and Development Expense
Research and development expense increased $58,000, or 8%, to $795,000 for the three months
ended December 31, 2006, from $737,000 for the three months ended December 31, 2005. This increase
was primarily the result of $277,000 in higher personnel and facility costs associated with the
expansion of our research and development teams. The expansion of these teams was through both an
internal shift of focus in our United States operations from manufacturing to research and
development, as well as through the hiring of additional personnel. The expansion of the research
and development teams helped support our increased attention to product development, clinical trials
and the management of regulatory trials designed to obtain FDA drug approvals for our Microcyn
products. This increase was offset by $232,000 in lower clinical trial expense, as we were
conducting our clinical trial on pre-operative skin preparation during the three months ended
December 31, 2005, which was completed in June 2006.
We
expect that research and development expense will continue to increase substantially in
future periods as we seek additional regulatory approvals of our Microcyn products, including the
beginning of our FDA related drug trials.
Selling,
General and Administrative Expense
Selling, general and administrative expense increased $736,000, or 19%, to $4.6 million for
the three months ended December 31, 2006, from $3.9 million for the three months ended December 31,
2005. Primarily this increase was due to $769,000 in non-cash stock-based compensation charges
incurred during the three months ended December 31, 2006, an increase of $565,000 over the non-cash
stock-based compensation charges incurred during the three months ended December 31, 2005. These
charges were primarily incurred for the options and warrants issued to a new board member, which
are amortized over the 2-year agreement, and for warrants issued for the settlement of litigation
with a past employee.
We
expect that selling, general and administrative expense will increase in the future as we
expand our infrastructure to support the requirements of being a public company.
Interest Expense and Interest Income
Interest expense increased $288,000 to $305,000 for the three months ended December 31,
2006, from $17,000 for the three months ended December 31, 2005. This increase was primarily the
result of a greater amount of debt during the three months ended December 31, 2006. Interest income
decreased $73,000 to $30,000 for the three months ended December 31, 2006, from $103,000 for the
three months ended December 31, 2005. This decrease was primarily the result of lower amounts of
interest-bearing instruments during the three months ended December 31, 2006.
34
Other Income (Expense), Net
Other income (expense), net was $565,000 net income for the three months ended December
31, 2006, compared with $111,000 net income for the three months ended December 31, 2005. This
change was primarily attributable to a $575,000 gain on foreign exchange translation for the three
months ended December 31, 2006, as compared to a gain of $82,000 for the three months ended
December 31, 2005.
Discontinued Operations
Loss from operations of discontinued business was $413,000 for the three months ended December
31, 2005. This charge represents the net loss associated with the entity QP which was consolidated
with our financial statements as required by FIN 46(R), and later deemed to be a discontinued
operation. As no relationship existed with this entity following the year ended March 31, 2006, no
charges were recognized during the three months ended December 31, 2006.
Comparison of Nine Months Ended December 31, 2006 and 2005
Revenues
Revenues increased $1.7 million, or 103%, to $3.4 million for the nine months ended December
31, 2006, from $1.7 million for the nine months ended December 31, 2005. During the nine months
ended December 31, 2006, product revenues were $2.7 million and service revenues were $639,000.
During the nine months ended December 31, 2005, product revenues were $1.2 million and service
revenues were $440,000. The $1.5 million, or 124%, increase in product revenues was primarily due
to the penetration by our direct sales forces into hospital and pharmacy markets, primarily in
Mexico, and from $604,000 in sales to our distributor in India.
The following table shows our product revenues by country (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
U.S. |
|
$ |
106 |
|
|
$ |
94 |
|
Mexico |
|
|
1,716 |
|
|
|
1,064 |
|
India |
|
|
604 |
|
|
|
|
|
Europe |
|
|
316 |
|
|
|
64 |
|
|
|
|
|
|
|
|
Total |
|
$ |
2,742 |
|
|
$ |
1,222 |
|
|
|
|
|
|
|
|
Cost of Revenues
Cost of revenues decreased $1.5 million, or 39%, to $2.2 million for the nine months ended
December 31, 2006, from $3.7 million for the nine months ended December 31, 2005. During the nine
months ended December 31, 2006, cost of revenues from product sales were $1.6 million and cost of
revenues from services were $641,000. During the nine months ended December 31, 2005, cost of
revenues from product sales were $2.9 million and cost of revenues from services were $757,000.
Cost of revenues from
product sales decreased $1.3 million for the nine months ended
December 31, 2006 as compared to the nine months ended December 31, 2005. Cost of revenues from
product sales in the United States decreased $790,000 due to the shifting of focus in our United
States facility from manufacturing to activities related
to the research and development of new Microcyn products. As a result, we began classifying
the expense associated with our United States facility as a research and development expense, and
therefore our fixed cost of product revenues decreased accordingly. Cost of revenues from product
sales in Europe increased $420,000 as our European manufacturing center expanded production
capacity and the associated fixed costs grew accordingly. Cost of revenues from product sales in
Mexico decreased $963,000 primarily due to the $931,000 write-off of
inventory, during the nine months ended December 31, 2005, due
to product labeling issues and expiring shelf-life of products as a
result of a one-time build-up of excess product inventory.
35
Our gross margin increased to a profit of $1.2 million, or 34% of revenues, for the nine
months ended December 31, 2006, from a gross loss of
$2.0 million for the nine months ended
December 31, 2005. Our gross margin from product sales increased to a profit of $1.2 million, or
42% of product revenues, for the nine months ended December 31, 2006, from a gross loss of $1.7
million for the nine months ended December 31, 2005. Primarily this improvement in our margins was
due to the decrease in our fixed cost of product manufacturing, in the U.S. and in Mexico, while
our product revenues increased over the same period.
Research and Development Expense
Research
and development expense increased $690,000, or 41%, to $2.4 million for the nine
months ended December 31, 2006, from $1.7 million for the nine months ended December 31, 2005.
This increase was primarily the result of $861,000 in higher personnel costs associated with the
expansion of our research and development teams. The expansion of these teams was through both an
internal shift of focus in our United States operations from manufacturing to research and
development, as well as through the hiring of additional personnel. The expansion of the research
and development teams helps support our increased attention to product development, clinical trials
and the management of regulatory trials designed to obtain FDA drug approvals for our Microcyn
products. This increase was offset by lower clinical trial expense, as we were conducting our
clinical trial on pre-operative skin preparation during the nine months ended December 31, 2005,
which was completed in June 2006.
Selling, General and Administrative Expense
Selling, general and administrative expense increased $896,000, or 8%, to $12.5 million for
the nine months ended December 31, 2006, from $11.6 million for the nine months ended December 31,
2005. Primarily this increase was due to $996,000 in non-cash stock-based compensation charges
incurred during the nine months ended December 31, 2006, an increase of $540,000 over the non-cash
stock-based compensation charges booked in the nine months ended December 31, 2005. These charges
were primarily incurred for the options and warrants issued to a new board member, which are
amortized over the 2-year agreement, and for the warrants issued for the settlement of litigation
with a past employee.
Interest Expense and Interest Income
Interest expense increased $445,000 to $565,000 for the nine months ended December 31,
2006, from $120,000 for the nine months ended December 31, 2005. This increase was primarily the
result of a greater debt balance during the nine months ended December 31, 2006. Interest income
decreased $42,000 to $130,000 for the nine months ended December 31, 2006, from $172,000 for the
nine months ended December 31, 2005. This increase was primarily the result of lower balances of
interest-bearing instruments during the nine months ended December 31, 2006.
Other Income (Expense), Net
Other income (expense), net was $657,000 net income for the nine months ended December
31, 2006, compared with $10,000 net income for the nine months ended December 31, 2005. Primarily
this increase is due to a $714,000 gain on foreign exchange translation during the nine months
ended December 31, 2006, as compared to a loss of $20,000 for the nine months ended December 31,
2005.
Discontinued Operations
Loss from operations of discontinued business was $587,000 for the nine months ended December
31, 2005. This charge represents the net loss associated with the entity QP which was consolidated
with our financial statements as required by FIN 46(R), and later deemed to be a discontinued
operation. As no relationship existed with this entity following the year ended March 31, 2006, no
charges were recognized during the nine months ended December 31, 2006.
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Liquidity and Capital Resources
Since our inception, we have incurred significant losses and, as of December 31, 2006, we
had an accumulated deficit of approximately $64.2 million. We have not yet achieved profitability.
We expect that our research and development and selling, general and administrative expenses will
continue to increase and, as a result, we will need to generate significant product revenues to
achieve profitability. We may never achieve profitability.
Sources of Liquidity
Since our inception, substantially all of our operations have been financed through the
sale of our common and convertible preferred stock. Through December 31, 2006, we had received net
proceeds of $3.5 million from the sale of common stock, $6.6 million from the sale of Series A
convertible preferred stock, $43.7 million from the sale of Series B convertible preferred stock,
$3.1 million from our Series C convertible preferred stock and $304,000 from the issuance of common
stock to employees, consultants and directors in connection with the exercise of stock options. We
have received additional funding through loans and capital equipment leases, as described below. We
have also used our collections of accounts receivable from revenues to date as a source of additional liquidity. As of December 31, 2006,
we had cash and cash equivalents of $2.5 million and debt under our notes payable and equipment
loans of $8.1 million.
On January 30, 2007, we closed the initial public offering of our common stock, raising gross
proceeds of $24.2 million. The net proceeds after commissions, underwriting discounts and non
accountable expenses paid to underwriters were $22.3 million.
On February 16, 2007, the underwriters of our initial public offering exercised their
option to purchase a portion of the over-allotment of shares per the terms of our underwriting
agreement. This purchase of common stock raised gross proceeds of $2.6 million. The net proceeds
after commissions, underwriting discounts and non accountable expenses paid to underwriters were
$2.4 million.
Cash Flows
As of December 31, 2006, we had cash and cash equivalents of $2.5 million, compared to
$12.7 million at December 31, 2005.
Net cash used in operating activities was $12.7 million for the nine months ended December 31,
2006, compared to $14.9 million for the nine months ended December 31, 2005. Net cash used in each
of these periods primarily reflects net loss for these periods, offset in part by non-cash charges
in operating assets and liabilities, non-cash stock-based
compensation and depreciation.
Net cash used in investing activities was $653,000, for the nine months ended December
31, 2006, compared to $491,000 for the nine months ended December 31, 2005. Cash was used primarily
to invest in property and equipment to support increased personnel and
manufacturing facility expansion in Europe and Mexico.
Net cash provided by financing activities was $9.1 million for the nine months ended
December 31, 2006, compared to $26.1 million for the nine months ended December 31, 2005. The net
cash provided by financing activities for nine months ended December 31, 2006 was primarily
attributable to the issuance of $8.4 million in debt and to a lesser extent the sale of $3.1
million of convertible preferred stock. These cash inflows were offset during the period by $1.0
million in payments on debt. The net cash provided by financing activities for nine months ended
December 31, 2005 was primarily attributable to the sale of convertible preferred stock, which
generated $27.0 million during that period.
Operating Capital and Capital Expenditure Requirements
We expect to continue to incur substantial operating losses in the future and to make
capital expenditures to support the expansion of our research and development programs and to
support our commercial operations. We anticipate using a portion of the proceeds from the initial
public offering to finance these activities. We expect it to take several years to obtain the
necessary regulatory approvals to commercialize Microcyn as a drug in the United States.
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We currently anticipate that our cash balance at December 31, 2006 and the proceeds from
our initial public offering and subsequent sale of over-allotment shares, together with our future
revenues and interest we earn, will be sufficient to meet our anticipated cash requirements through
at least the next 12 months.
Our future funding requirements will depend on many factors, including:
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the scope, rate of progress and cost of our clinical trials and other research and development activities; |
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future clinical trial results; |
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the terms and timing of any collaborative, licensing and other arrangements that we may establish; |
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the cost and timing of regulatory approvals; |
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the cost and delays in product development as a result of any changes in regulatory oversight applicable
to our products; |
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the cost and timing of establishing sales, marketing and distribution capabilities; |
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the effect of competing technological and market developments; |
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the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual
property rights; and |
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the extent to which we acquire or invest in businesses, products and technologies. |
If we are unable to generate a sufficient amount of revenues to finance our operations,
research and development and regulatory plans, we may seek to raise additional funds through public
or private equity offerings, debt financings, capital lease transactions, corporate collaborations
or other means. We may seek to raise additional capital due to favorable market conditions or
strategic considerations even if we have sufficient funds for planned operations. The sale of
additional equity or convertible debt securities could result in dilution to our stockholders. To
the extent that we raise additional funds through collaborative arrangements, it may be necessary
to relinquish some rights to our technologies or grant licenses on terms that are not favorable to
us. We do not know whether additional funding will be available on acceptable terms, or at all. A
failure to secure additional funding when needed may require us to curtail certain operational
activities, including regulatory trials, sales and marketing, and international operations and
would have a material adverse effect on our future business and financial condition.
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Market Risk
Our exposure to interest rate risk is confined to our excess cash in highly liquid money
market funds denominated in U.S. dollars. The primary objective of our investment activities is to
preserve our capital to fund operations. We also seek to maximize income from our investments
without assuming significant risk. We do not use derivative financial instruments in our investment
portfolio. Our cash and investments policy emphasizes liquidity and preservation of principal over
other portfolio considerations.
Foreign Currency Market Risks
We have two significant subsidiaries, one each in Europe and Mexico. Revenues and expenses
associated with these subsidiaries are denominated in foreign currency. Accordingly, our operating
results are affected by exchange
rate fluctuations between the U.S. dollar and these foreign currencies In order to mitigate
our exposure to foreign currency rate fluctuations, we maintain minimal cash balances in the
foreign subsidiaries. However, if we are successful in our efforts to grow internationally, our
exposure to foreign currency rate fluctuations, primarily the Euro and Mexican Peso, may increase.
We are also exposed to foreign currency risk related to the Euro denominated and Mexican Peso
denominated intercompany receivables. Because our intercompany receivables are accounted for in
Euros and US dollars, any appreciation or devaluation of the Euro or Mexican Peso will result in a
gain or loss to the consolidated statements of operations.
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We do not currently enter into forward exchange contracts to hedge exposure denominated in
foreign currencies or any other derivative financial instrument for trading or speculative
purposes. In the future, if we believe our currency exposure merits, we may consider entering into
transactions to help mitigate the risk.
Item 4. Controls and Procedures
(a) Evaluation of disclosure controls and procedures. We maintain disclosure controls and
procedures, as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934
(the Exchange Act), that are designed to ensure that information required to be disclosed by us
in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and
reported within the time periods specified in Securities and Exchange Commission rules and forms,
and that such information is accumulated and communicated to our management, including our chief
executive officer and chief financial officer, as appropriate, to allow timely decisions regarding
required disclosure. In designing and evaluating our disclosure controls and procedures, management
recognized that disclosure controls and procedures, no matter how well conceived and operated, can
provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and
procedures are met. In response to comments from our auditors and our own investigations, our disclosure controls and procedures have been designed to meet, and
management believes that they meet, reasonable assurance standards. Additionally, in designing
disclosure controls and procedures, our management necessarily was required to apply its judgment
in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The
design of any disclosure controls and procedures also is based in part upon certain assumptions
about the likelihood of future events, and there can be no assurance that any design will succeed
in achieving its stated goals under all potential future conditions. Based on their evaluation as
of the end of the period covered by this Quarterly Report on Form 10-Q, our chief executive officer
and chief financial officer have concluded that, subject to the limitations noted above, our
disclosure controls and procedures were effective to ensure that material information relating to
us, including our consolidated subsidiaries, is made known to them by others within those entities,
particularly during the period in which this Quarterly Report on Form 10-Q was being prepared.
(b) Changes in internal controls. In the quarter ending December 31, 2006, we continued to
make improvements to our internal control structure and financial reporting processes, including
revising our authorization matrix and our inventory control segregation policy in The Netherlands;
establishing fixed closing and reporting deadlines and fixed budgeting and forecasting schedules;
refining our procedures for calculating and recording bad debt reserves and potential revenue
adjustments; establishing procedures for sell-through method in The Netherlands; revising certain
aspects of our purchasing policy and procedures; conducting an actuarial study of our social
retirement funding in Mexico; and formalizing procedures to ensure that all significant
transactions undergo a legal and accounting review and are reviewed and approved by our board of directors.
Other than these changes, there were no significant changes in our internal control over
financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) identified in connection
with the evaluation described in Item 4(a) above that occurred during our last fiscal quarter that
has materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
Legal Matters
In
April 2005, the Company was named as a defendant in an employment related matter under a complaint
filed by one of its former employees in the Superior Court of the State of California in the County
of Sonoma in April 2005. The Company entered into a settlement agreement with the plaintiff in
November 2006, which provides for the payment of $250,000 and the issuance of a warrant to purchase
50,000 shares of our common stock exercisable at $3.00 per share. The warrants, which are
non-forfeitable at the date of issuance, were recorded at fair value which resulted in expense of
$365,000. The expense was recorded in the three months ended December 31, 2006 in selling, general
and administrative expense. The issuance of the warrants was subject to the Company obtaining
appropriate waivers from our convertible preferred stockholders which was obtained in December
2006. The cash payment was made in February 2006. Under the terms of the agreement, the
plaintiff has agreed to dismiss his claim and has waived
any other previous claims against us. A $300,000 reserve was
established at March 31, 2006
based on the Companys best estimate of the potential loss. The reserve was reduced to the cash
liability of $250,000 at December 31, 2006 and is a component of accrued expenses and other current
liabilities in the accompanying condensed consolidated balance sheet.
In November 2005, the Company identified a possible criminal misappropriation of its
technology in Mexico, and it notified the Mexican Attorney Generals office. The Company believes
the Mexican Attorney General is currently conducting an investigation.
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On March 14, 2006, the Company filed suit in the U.S. District Court for the Northern
District of California against Nofil Corporation and Naoshi Kono,
Chief Executive Officer of Nofil for breach of contract, misappropriation of trade secrets and trademark infringement. The Company
believes that Nofil Corporation violated key terms of both an exclusive purchase agreement and
non-disclosure agreement by contacting and working with a potential competitor in Mexico. In the
complaint, the Company seeks damages of $3,500,000 and immediate
injunctive relief. On February 13, 2007, Nofil filed an answer and
cross-complaint. The cross-complaint, which alleges fraudulent
inducement to enter contracts, breach of non-disclosure contract,
trade secret misappropriation, conversion and violation under civil
RICO statutes by the Company, seeks damages of $4.5 million and
equitable relief. The Company believes that Nofils claims are
without merit and intends to defend its position with respect to this
matter. No trial date
has been set.
The Company is currently a party in two trademark matters asserting confusion in
trademarks with respect to the Companys use of the name Microcyn60 in Mexico. Although the Company
believes that the nature and intended use of its products are different from those with the similar
names, it has agreed with one of the parties to stop using the name Microcyn60 by September 2007.
Although such plaintiff referred the matter to the Mexico Trademark Office, the Company is not
aware of a claim for monetary damages. Company management believes that the name change will
satisfy an assertion of confusion; however, Company management believes that the Company could
incur a possible loss of approximately $100,000 for the use of the name Microcyn60 during the
year following the date of settlement.
In June 2006, the Company received a written communication from the grantor of a license
to an earlier version of its technology indicating that such license was terminated due to an
alleged breach of the license agreement by the Company. The license agreement extends to the
Companys use of the technology in Japan only. While the Company does not believe that the
grantors revocation is valid under the terms of the license agreement and no legal claim has been
threatened to date, the Company cannot provide any assurance that the grantor will not take legal
action to restrict the Companys use of the technology in the licensed territory.
While the Company management does not anticipate that the outcome of this matter is
likely to result in a material loss, there can be no assurance that if the grantor pursues legal
action, such legal action would not have a material adverse effect on the Companys financial
position or results of operations.
In August 2006, the Company received a show cause letter from the U.S. Environmental
Protection Agency (EPA), which stated that, in tests conducted by the EPA, Cidalcyn was found to
be ineffective in killing certain specified pathogens when used according to label directions.
Based on its results, the EPA strongly recommended that the Company immediately recalled all
Cidalcyn distributed on and after September 28, 2005. Accordingly, the Company has commenced a
voluntary recall of Cidalcyn. Although the Company has not marketed Cidalcyn on a large commercial
scale, it has provided it in small quantities to numerous hospitals solely for use in product
evaluation exercises. In a second letter, the EPA stated it intended to file a civil administrative
complaint against the Company for violation of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). Under FIFRA, the EPA could assess civil penalties related to the sale and
distribution of a pesticide product not meeting the labels claims as a broad-spectrum hospital
disinfectant. The Company believes that such civil penalties could be up to $200,000. The Company
currently cannot estimate the actual amount of penalties which may be incurred. The Company does
not believe this issue will have a material impact on future operations. The amount of expense to
be incurred with regard to the recall of the product is currently not estimable, however, the
Company believes any potential expense would be insignificant because the product was not
commercialized and the number of samples distributed was minimal. For these reasons, the Company
has not established an accrual for the product recall.
In September 2006, a consulting firm in Mexico City contacted the Company threatening
legal action in Mexico, alleging breach of contract and claiming damages of $225,000. A formal
compliant has not been served and no trial date has been set. In December 2006, the Company entered
into a settlement agreement with the consulting firm where the Company paid $115,000 for the
dismissal of their claim and waiver of any previous claims against the Company.
The
Company, on occasion, is involved in legal matters arising in the ordinary
course of its business. While management believes that such matters are currently insignificant,
there can be no assurance that matters
arising in the ordinary course of business for which the Company is or could become involved
in litigation, will not have a material adverse effect on its business, financial condition or
results of operations.
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Item 1A. Risk Factors
Factors that May Affect Results
Risks Related to Our Business
We have a history of losses, we expect to continue to incur losses and we may never achieve
profitability.
We have incurred significant net losses in each fiscal year since our inception,
including losses of $7.3 million, $16.5 million, $23.1 million and $13.5 million for the years
ended March 31, 2004, 2005 and 2006 and the nine months ended December 31, 2006, respectively. Our
accumulated deficit as of December 31, 2006 was $64.2 million. We have yet to demonstrate that we
can generate sufficient sales of our products to become profitable. The extent of our future
operating losses and the timing of profitability are highly uncertain, and we may never achieve
profitability. Even if we do generate significant revenues from our product sales, we expect that
increased operating expenses will result in significant operating losses in the near term as we,
among other things:
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finance our sales and marketing capabilities in the United States and internationally; |
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conduct preclinical studies and clinical trials on our products and product candidates; |
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seek FDA clearance to market Microcyn as a drug in the United States; |
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increase our research and development efforts to enhance our existing products,
commercialize new products and develop new product candidates; and |
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establish additional and expand existing manufacturing facilities. |
As a result of these activities, we will need to generate significant revenue in order to
achieve profitability and may never become profitable. We must also maintain specified cash
reserves in connection with our loan and security agreement which may limit our investment
opportunities. Failure to maintain these reserves could result in our lender foreclosing against
our assets or imposing significant restrictions on our operations. Even if we do achieve
profitability, we may not be able to sustain or increase profitability on an ongoing basis.
Without completion of our initial public offering, or the raise of capital through an
alternate funding source, we would curtail certain operational activities in order to reduce costs.
In the event that we are required to raise additional capital, we cannot provide any assurance
that we will secure any commitments for new financing on acceptable terms, if at all.
Because all of our products are based on our Microcyn platform technology, we will need to
generate sufficient revenues from the sale of Microcyn to execute our business plan.
All of our products are based on our Microcyn platform technology, and we do not have any
non-Microcyn product candidates that will generate revenues in the foreseeable future. Accordingly,
we expect to derive substantially all of our future revenues from sales of our current Microcyn
products. We have only been selling our products since July 2004, and substantially all of our
historical product revenues have been from sales of Microcyn in Mexico. Although we began selling
in Europe in October 2004, in the United States in June 2005, and in India in July 2006, our
product revenues outside of Mexico were not significant prior to our current fiscal year. For
example, product revenues from countries outside of Mexico were just 9% of our product revenues for
the year ended March 31, 2006, but 37% of our product revenues for the nine months ended December
31, 2006 were from countries outside Mexico. Microcyn has not been adopted as a standard of care
for wound treatment in any country and may not gain acceptance among physicians, nurses, patients,
third-party payors and the medical community.
Existing protocols for wound care are well established within the medical community and tend
to vary geographically, and healthcare providers may be reluctant to alter their protocols to
include the use of Microcyn. If Microcyn does not achieve an adequate level of acceptance, we will
not generate sufficient revenues to become profitable.
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One of our non-commercialized products, when recently tested by the U.S. Environmental
Protection Agency, or EPA, did not meet certain efficacy standards based on an EPA test protocol
that used parameters that differed from those parameters previously used by us when we originally
registered this product as an EPA registered disinfectant product. As a result, we have
discontinued sampling, promotion and all distribution of this non-commercialized product.
In October 2004, after EPA review of our registration filing, including the results of
disinfectant efficacy testing conducted by an independent laboratory retained by us, we obtained
EPA authorization, or registration, for the distribution and sale of our Microcyn-based product,
which we call Cidalcyn, as a hospital grade disinfectant. Although we have not commercialized
Cidalcyn, we previously provided samples to potential marketing partners and other entities for
product evaluation. Subsequently, in July 2006, we were informed by the EPA that in more recent
tests conducted by the EPA, Cidalcyn did not meet efficacy standards when tested against three
specified pathogens (Pseudomonas aeruginosa, Staphylococcus aureus and Mycobacterium tuberculosis)
when used according to label directions. These new results prevent us from marketing Cidalcyn as a
hospital grade disinfectant. We believe the EPA test protocol utilizes a bacterial culture to
challenge a disinfectant in a test method which does not replicate a human wound environment and
which is not used to evaluate the safety or efficacy of wound care products by the FDA or CE Mark.
We believe the EPA test made use of a bacterial culture which contained a significantly higher
concentration of pathogens than the culture used in the independent test, the results of which we
submitted to the EPA for registration purposes. This increased concentration of bacteria might have
overwhelmed our Cidalcyn product. Subsequent testing we have conducted appears to have confirmed
the EPAs results against two of the three pathogens. Based on the EPAs own testing, the EPA
strongly recommended that we immediately recall all Cidalcyn distributed on and after September 28,
2005. Accordingly, we promptly and voluntarily ceased all distribution of Cidalcyn to end users,
and we are not providing the product to distributors or retailers for re-distribution to third
parties or end users; we have ceased promoting Cidalcyn; and we have contacted the entities and
small number of individuals in the United States who are not our employees, to whom the Cidalcyn
product had been provided for evaluation purposes during the one-year period (the products
shelf-life) prior to our receipt of the EPAs recent notification to ensure they have been informed
not to use any remaining quantities they might have in their possession. In August 2006, we
received a show cause letter from the EPA stating that it was prepared to file a civil
administrative complaint against us for violation of federal pesticide legislation in connection
with the sale or distribution of a pesticide that did not meet the labels efficacy claims, and it
gave us the opportunity to advise the EPA of any factors we believe the EPA should consider before
issuing a civil complaint. We have engaged in discussions with the EPA since that time and are
working cooperatively with the EPA to resolve this matter. We believe that any civil penalties that
might be assessed against us in connection with such a civil complaint would not be in a material
amount. Unless and until we provide new information to support the original label claims of
Cidalcyn to the EPA, there will not be any sales or other distributions of the product in the
United States as a hospital grade disinfectant.
We do not have the necessary regulatory approvals to market Microcyn as a drug in the United
States.
We have obtained three 510(k) clearances in the United States that permit us to sell
Microcyn as a medical device to clean, moisten and debride wounds. However, we do not have the
necessary regulatory approvals to market Microcyn in the United States as a drug, which we will
need to obtain in order to execute our business plan. Before we are permitted to sell Microcyn as a
drug in the United States, we must, among other things, successfully complete additional
preclinical studies and well-controlled clinical trials, submit a New Drug Application, or NDA, to
the FDA and obtain FDA approval. In July 2006, we completed a controlled clinical trial for
pre-operative skin preparation. After completion of this trial, the FDA advised us that it is
considering adopting new heightened performance requirements for evaluating efficacy of products
designed to be used in pre-operative skin preparation such as ours. In discussions with the FDA,
the FDA has not provided us with the definitive timing for, or parameters of, any such
requirements, and has informally stated that it is uncertain during what time frame it will be able
to do so. We plan to continue our discussions with the FDA regarding the possible timing and
parameters of any new guidelines for evaluating efficacy for pre-operative skin preparations.
Depending on the ultimate position of the
FDA regarding performance criteria for pre-operative skin preparations, we may reassess our
priorities, clinical timelines and schedules for pursuing a pre-operative skin preparation
indication or may decide not to pursue this indication. We also intend to seek FDA approval for the
use of Microcyn to treat infections in wounds.
We have sponsored the majority of physicians performing physician clinical studies of
Microcyn and in some cases, the physicians who performed these studies also hold equity in our
company. The physician clinical studies were performed in the United States, Mexico and Italy, and
used various endpoints, methods and controls. These studies were not intended to be rigorously
designed or controlled clinical trials and, as such, did not have all of the
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controls required for
clinical trials used to support an NDA submission to the FDA in that they did not include blinding,
randomization, predefined clinical endpoints, use of placebo and active control groups or U.S. good
clinical practice requirements. Consequently, the results of these physician clinical studies may
not be used by us to support an NDA submission for Microcyn to the FDA. In addition, any results
obtained from clinical trials designed to support an NDA submission for Microcyn to the FDA may not
be as favorable as results from such physician clinical studies and otherwise may not be sufficient
to support an NDA submission or FDA approval of any Microcyn NDA.
The FDA approval process is expensive and uncertain, requires detailed and comprehensive
scientific and other data and generally takes several years. Despite the time and expense exerted,
approval is never guaranteed. We do not know whether we will obtain favorable results in our
preclinical and clinical studies or whether we will obtain the necessary regulatory approvals to
market Microcyn as a drug in the United States. We anticipate that obtaining approval for the use
of Microcyn to treat infections in wounds in the United States will take several years. Even if we
obtain FDA approval to sell Microcyn as a drug, we may not be able to successfully commercialize
Microcyn as a drug in the United States and may never recover the substantial costs we have
invested in the development of our Microcyn products.
Our inability to raise additional capital on acceptable terms in the future may cause us to
curtail certain operational activities, including regulatory trials, sales and marketing, and
international operations, in order to reduce costs and sustain the business, and would have a
material adverse effect on our business, and financial condition.
We expect capital outlays and operating expenditures to increase over the next several
years as we work to commercialize our products and expand our infrastructure. We have entered into
debt financing arrangements which are secured by all of our assets. We may need to raise additional
capital to, among other things:
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sustain commercialization of our current products or new products; |
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increase our sales and marketing efforts to drive market adoption and address competitive developments; |
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fund our clinical trials and preclinical studies; |
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expand our manufacturing capabilities; |
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acquire or license technologies; and |
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finance capital expenditures and our general and administrative expenses. |
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Our present and future funding requirements will depend on many factors, including: |
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the progress and timing of our clinical trials; |
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the level of research and development investment required to maintain and improve our technology position; |
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cost of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; |
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our efforts to acquire or license complementary technologies or acquire complementary businesses; |
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changes in product development plans needed to address any difficulties in commercialization; |
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competing technological and market developments; and |
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changes in regulatory policies or laws that affect our operations. |
If we raise additional funds by issuing equity securities, dilution to our stockholders
could result. Any equity securities issued also may provide for rights, preferences or privileges
senior to those of holders of our common stock. If we raise additional funds by issuing debt
securities, these debt securities would have rights, preferences and privileges senior to those of
holders of our common stock, and the terms of the debt securities issued could impose significant
restrictions on our operations. If we raise additional funds through collaborations and licensing
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arrangements, we might be required to relinquish significant rights to our technologies or
products, or grant licenses on terms that are not favorable to us. A failure to obtain adequate
funds may cause us to curtail certain operational activities, including regulatory trials, sales
and marketing, and international operations, in order to reduce costs and sustain the business, and
would have a material adverse effect on our business and financial condition.
Delays or adverse results in clinical trials could result in increased costs to us and delay
our ability to generate revenue.
Clinical trials can be long and expensive, and the outcome of clinical trials is
uncertain and subject to delays. It may take several years to complete clinical trials, if at all,
and a product candidate may fail at any stage of the clinical trial process. The length of time
required varies substantially according to the type, complexity, novelty and intended use of the
product candidate. Interim results of a preclinical study or clinical trial do not necessarily
predict final results, and acceptable results in preclinical studies or early clinical trials may
not be repeatable in later subsequent clinical trials. The commencement or completion of any of our
clinical trials may be delayed or halted for a variety of reasons, including the following:
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FDA requirements for approval, including requirements for testing efficacy or safety, may change; |
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the FDA or other regulatory authorities do not approve a clinical trial protocol; |
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patients do not enroll in clinical trials at the rate we expect; |
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delays in reaching agreement on acceptable clinical trial agreement terms with prospective sites; |
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delays in obtaining institutional review board approval to conduct a study at a prospective site; |
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third party clinical investigators do not perform our clinical trials on our anticipated
schedule or consistent with the clinical trial protocol and good clinical practices, or the
third party organizations do not perform data collection and analysis in a timely or accurate
manner; |
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governmental regulations or administrative actions are changed; and |
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insufficient funds to continue our clinical trials. |
We do not know whether our existing or any future clinical trials will demonstrate safety
and efficacy sufficiently to result in additional FDA approvals. While a number of physicians have
conducted clinical studies assessing the safety and efficacy of Microcyn for various indications,
the data from these studies is not sufficient to support approval of Microcyn as a drug in the
United States. In addition, further studies and trials could show
different results. For example, in an independent physician study of
10 patients in which procedures were not fully delineated, published in February 2007, four patients discontinued
treatment with Demacyn due to pain, and beneficial change in wound
microbiology was found in only one of the six remaining patients. We will be required to conduct additional clinical trials prior to seeking approval
of Microcyn for additional indications. Our failure to adequately demonstrate the safety and
efficacy of our product candidates to the satisfaction of the FDA will prevent our receipt of FDA
approval for additional indications and, ultimately, impact commercialization of our products in
the United States. If we experience significant delays or adverse results in clinical trials, our
financial results and the commercial prospects for products based on Microcyn will be harmed, our
costs would increase and our ability to generate revenue would be delayed.
If we fail to obtain, or experience significant delays in obtaining additional regulatory
clearances or approvals to market our current or future products, we may be unable to commercialize
these products.
Developing, testing, manufacturing, marketing and selling of medical technology products
are subject to extensive regulation by numerous governmental authorities in the United States and
other countries. The process of obtaining regulatory clearance and approval of medical technology
products is costly and time consuming. Even though the underlying product formulation may be the
same or similar, our products are subject to different regulations and approval processes depending
upon their intended use. In the United States, use of Microcyn to cleanse and debride a wound comes
within the medical device regulation framework, while use of Microcyn to treat infections in wounds
will require us to seek FDA approval of Microcyn as a drug in the United States.
To obtain regulatory approval of our products as drugs in the United States, we must
first show that our products are safe and effective for target indications through preclinical
studies (laboratory and animal testing) and clinical trials (human testing). The FDA generally
clears marketing of a medical device through the 510(k) pre-
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market clearance process if it is
demonstrated that the new product has the same intended use and the same or similar technological
characteristics as another legally marketed Class II device, such as a device already cleared by
the FDA through the 510(k) premarket notification process, and otherwise meets the FDAs
requirements. Product modifications, including labeling the product for a new intended use, may
require the submission of a new 510(k) clearance and FDA approval before the modified product can
be marketed.
We do not know whether our products based on Microcyn will receive approval from the FDA
as a drug. The data from clinical studies of Microcyn conducted by physicians to date will not
satisfy the FDAs regulatory criteria for approval of an NDA. In order for us to seek approval for
the use of Microcyn as a drug in the treatment of infections in wounds, we will be required to
conduct additional preclinical and clinical trials and submit applications for approval to the FDA.
For example, we are currently planning to conduct a pilot study of Microcyn for the treatment of
wound infections, and we will need to conduct additional non-clinical and well-controlled clinical
trials in order to generate data to support FDA approval of Microcyn for this indication.
The outcomes of clinical trials are inherently uncertain. In addition, we do not know
whether the necessary approvals or clearances will be granted or delayed for future products. The
FDA could request additional information or clinical testing that could adversely affect the time
to market and sale of products as drugs. If we do not obtain the requisite regulatory clearances
and approvals, we will be unable to commercialize our products as drugs or devices and may never
recover any of the substantial costs we have invested in the development of Microcyn.
Distribution of our products outside the United States is subject to extensive government
regulation. These regulations, including the requirements for approvals or clearance to market, the
time required for regulatory review and the sanctions imposed for violations, vary from country to
country. We do not know whether we will obtain regulatory approvals in such countries or that we
will not be required to incur significant costs in obtaining or maintaining these regulatory
approvals. In addition, the export by us of certain of our products that have not yet been cleared
for domestic commercial distribution may be subject to FDA export restrictions. Failure to obtain
necessary regulatory approvals, the restriction, suspension or revocation of existing approvals or
any other failure to comply with regulatory requirements would have a material adverse effect on
our future business, financial condition, and results of operations.
If our products do not gain market acceptance, our business will suffer because we might not
be able to fund future operations.
A number of factors may affect the market acceptance of our products or any other
products we develop or acquire, including, among others:
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the price of our products relative to other treatments for the same or similar treatments; |
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the perception by patients, physicians and other members of the health care community of
the effectiveness and safety of our products for their indicated applications and
treatments; |
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our ability to fund our sales and marketing efforts; and |
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the effectiveness of our sales and marketing efforts. |
If our products do not gain market acceptance, we may not be able to fund future
operations, including developing, testing and obtaining regulatory approval for new product
candidates and expanding our sales and marketing efforts for our approved products, which would
cause our business to suffer.
We may incur significant liabilities in connection with our relationship with a former
distributor in Mexico, and our results of operations may be negatively affected by the termination
of this relationship.
On June 16, 2005, we entered into a series of agreements with Quimica Pasteur, or QP, a
Mexico-based distributor of pharmaceutical products to hospitals and health care entities owned or
operated by the Mexican Ministry of Health, or MOH. These agreements provided, among other things,
for QP to act as our exclusive distributor of Microcyn to the MOH for a period of three years. We
were granted an option to acquire all except a minority share of the equity of QP directly from its
principals. In addition, two of our employees were appointed as officers of QP, which resulted in
the establishment of financial control of QP by our company under applicable accounting literature.
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As a result of our agreements, we were required to consolidate QPs operations with our
financial results. In connection with our audit of QPs financial statements in late 2005, we were
made aware of a number of facts that suggested that QP or its principals may have engaged in some
form of tax avoidance practice prior to the execution of the agreements between our company and QP.
We did not discover these facts prior to our execution of these agreements or for several months
thereafter. Our prior independent auditors informed us that we did not have effective anti-fraud
programs designed to detect the type of activities in which QPs principals engaged or the
personnel to effectively evaluate and determine the appropriate accounting for non-routine or
complex accounting transactions. Our audit committee engaged an outside law firm to conduct an
investigation whose findings implicated QPs principals in a systemic tax avoidance practice prior
to June 16, 2005. We estimate that QPs liability for taxes, interest and penalties related to
these practices could amount to $7 million or more. Based on the results of this investigation, we
terminated our agreements with QP effective March 26, 2006.
Although we do not believe that we are responsible for any tax avoidance practices of
QPs principals prior to June 16, 2005, the Mexican taxing authority could make a claim against us
or our Mexican subsidiary. We have been informed by counsel in Mexico that the statute of
limitations, including for actions for fraud, is five years from March 31, 2006. QP had a well-established relationship with the MOH. We lost the benefit
of this relationship when we terminated our agreements with QP.
Our former independent registered public accounting firm has notified us of a number of reportable
events constituting a material weakness over financial reporting which, if not successfully
remedied, may among other things, impact our ability to develop reliable financial statements and
comply with our reporting obligations as a public company.
In August 2006, our former independent registered public accounting firm,
PricewaterhouseCoopers LLP, or PWC, notified us of a number of deficiencies it believes comprise
reportable events that may, among other things, impact our ability to develop reliable financial
statements. In its letter, PWC stated that it had advised our audit committee of the following:
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the absence of financial accounting personnel with
sufficient skills and experience to effectively evaluate
and determine the appropriate accounting for non-routine
and/or complex accounting transactions consistent with
accounting principles generally accepted in the United
States, which resulted in a number of material audit
adjustments to the financial statements during the course
of audit procedures; |
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the failure to maintain effective controls to ensure the
identification of accounting issues related to and the
proper accounting for stock options with the right of
rescission that were granted under certain stock option
plans that required registration or qualification under
federal and state securities laws primarily due to
insufficient oversight and lack of personnel in the
accounting and finance organization with the appropriate
level of accounting knowledge, experience and training; |
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the failure to maintain an effective anti-fraud program
designed to detect and prevent fraudulent activities in QP; |
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the need to expand significantly the scope of the audit of
QP to assess the impact of identified fraudulent activities
on our financial statements, in which regard PWC advised
our audit committee that the results of the fraud
investigation may cause PWC to be unwilling to be
associated with our financial statements; |
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the tone at the top set by our senior management does not
appear to encourage an attitude within our company that
controls are important or that established controls cannot
be circumvented; |
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we did not have the appropriate financial management and
reporting infrastructure in place to meet the demands that
will be placed upon us as a public company, including the
requirements of the Sarbanes-Oxley Act of 2002, and that we
will be unable to report our financial results accurately
or in a timely manner; and |
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significant control deficiencies, when considered in the
aggregate, constituted a material weakness over financial
reporting. |
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We have filed a copy of the letter from PWC as an exhibit to the registration statement
of which this prospectus forms a part. For additional information, please see Change in
Independent Registered Public Accounting Firm.
Our
current independent registered public accounting firm also identified
matters relating to the our need to evaluate the structure of our
accounting department, standardize asset custody, recordkeeping and authorization
procedures, and institute uniform systems designed to ensure our
ability to meet the reporting and financial statement disclosures
requirements.
We have agreed to change the brand name of our product in Mexico, which may result in the loss
of any brand recognition that we have established with users of our products.
In accordance with the settlement of a trademark infringement lawsuit filed against us in
Mexico, we have agreed to stop using the name Microcyn60 in Mexico by September 2007. In addition,
in May 2006, a complaint was filed against us for trademark confusion in connection with the same
tradename, and we are in settlement negotiations concerning such claim. We have marketed our
products in Mexico under the brand name of Microcyn60 since 2004. In the nine months ended December
31, 2006, 63% of our product revenues were derived from Mexico. As a result of our agreement to
change our product name, we may lose the benefit of the brand name recognition we have generated in
the region and our product sales in Mexico could decline. In locations where we have distributed
our products, we believe that the brand names of those products have developed name recognition
among consumers who purchase them. Any change to the brand name of our other products may cause us
to lose such name recognition, which may lead to confusion in the marketplace and a decline in
sales of our products.
If our competitors develop products similar to Microcyn, we may need to modify or alter our
business strategy, which may delay the achievement of our goals.
Competitors may develop products with similar characteristics as Microcyn. Such similar
products marketed by larger competitors can hinder our efforts to penetrate the market. As a
result, we may be forced to modify or alter our business and regulatory strategy and sales and
marketing plans, as a response to changes in the market, competition and technology limitations,
among others. Such modifications may pose additional delays in achieving our goals.
If we are unable to expand our direct domestic sales force, we may not be able to successfully
sell our products in the United States.
We currently sell Microcyn in the United States through a network of one national and
five regional distributors and our medical and clinical employees. We plan to sell directly into
the United States markets and we plan to expand our domestic sales force. Developing a sales force
is expensive and time consuming, and the lack of qualified sales personnel could delay or limit the
success of our product launch. Our domestic sales force, if established, will be competing with the
sales operations of our competitors, which are better funded and more experienced. We may not be
able to develop domestic sales capacity on a timely basis or at all.
Our dependence on distributors for sales could limit or prevent us from selling our products
and from realizing long-term revenue growth.
We currently depend on distributors to sell Microcyn in the United States, Europe and
other countries and intend to continue to sell our products primarily through distributors in
Europe and the United States for the foreseeable future. In addition, if we are unable to expand
our direct sales force, we will continue to rely on
distributors to sell Microcyn. Our existing distribution agreements are generally short-term
in duration, and we may need to pursue alternate distributors if the other parties to these
agreements terminate or elect not to renew their agreements. If we are unable to retain our current
distributors for any reason, we must replace them with alternate distributors experienced in
supplying the wound care market, which could be time-consuming and divert managements attention
from other operational matters. In addition, we will need to attract additional distributors to
expand the geographic areas in which we sell Microcyn. Distributors may not commit the necessary
resources to market and sell our products to the level of our expectations, which could harm our
ability to generate revenues. In addition, some of our distributors may also sell products that
compete with ours. In some countries, regulatory licenses must be held by residents of the country.
For example, the regulatory approval for one product in India is owned and held by our Indian
distributor. If the licenses are not in our name or under our control, we might not have the power
to ensure their ongoing effectiveness and use by us. If current or future distributors do not
perform adequately, or we are unable to locate distributors in particular geographic areas, we may
not realize long-term revenue growth.
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We depend on a contract sales force to sell our products in Mexico.
We currently depend on a contract sales force to sell Microcyn in Mexico. Our existing
agreement is short-term in duration and can be terminated by either party upon 30 days written
notice. If we are unable to retain our current agreement for any reason, we may need to build our
own internal sales force or find an alternate source for contract sales people. We may be unable to
find an alternate source, or the alternate sources sales force may not generate sufficient
revenue. If our current or future contract sales force does not perform adequately, we may not
realize long-term revenue growth in Mexico.
We intend to license or collaborate with third parties in various potential markets, and
events involving these strategic partners or any future collaborations could delay or prevent us
from developing or commercializing products.
Our business strategy and our short- and long-term operating results will depend in part
on our ability to execute on existing strategic collaborations and to license or partner with new
strategic partners. We believe collaborations allow us to leverage our resources and technologies
and to access markets that are compatible with our own core areas of expertise while avoiding the
cost of establishing a direct sales force in each market.
To penetrate our target markets, we may need to enter into additional collaborative agreements
to assist in the development and commercialization of future products. For example, depending upon
our analysis of the time and expense involved in obtaining FDA approval to sell a product to treat
open wounds, we may choose to license our technology to a third party as opposed to pursuing
commercialization ourselves. Establishing strategic collaborations is difficult and time-consuming.
Potential collaborators may reject collaborations based upon their assessment of our financial,
regulatory or intellectual property position and our internal capabilities. Our discussions with
potential collaborators may not lead to the establishment of new collaborations on favorable terms.
We have limited control over the amount and timing of resources that our current collaborators or
any future collaborators devote to our collaborations or potential products. These collaborators
may breach or terminate their agreements with us or otherwise fail to conduct their collaborative
activities successfully and in a timely manner. Further, our collaborators may not develop or
commercialize products that arise out of our collaborative arrangements or devote sufficient
resources to the development, manufacture, marketing or sale of these products. By entering into a
collaboration, we may preclude opportunities to collaborate with other third parties who do not
wish to associate with our existing third party strategic partners. Moreover, in the event of
termination of a collaboration agreement, termination negotiations may result in less favorable
terms.
If we fail to comply with ongoing regulatory requirements, or if we experience unanticipated
problems with our products, these products could be subject to restrictions or withdrawal from the
market.
Regulatory approvals or clearances that we currently have and that we may receive in the
future are subject to limitations on the indicated uses for which the products may be marketed, and
any future approvals could contain requirements for potentially costly post-marketing follow-up
studies. If the FDA determines that our promotional materials or activities constitute promotion of
an unapproved use or we otherwise fail to comply with FDA regulations, we may be subject to
regulatory enforcement actions, including a warning letter, injunction, seizure, civil fine or
criminal penalties. In addition, the manufacturing, labeling, packaging, adverse event reporting,
storage, advertising, promotion, distribution and record-keeping for approved products are subject
to extensive regulation. Our manufacturing facilities, processes and specifications are subject to
periodic inspection by the FDA, European
and other regulatory authorities and from time to time, we may receive notices of deficiencies
from these agencies as a result of such inspections. Our failure to continue to meet regulatory
standards or to remedy any deficiencies could result in restrictions being imposed on products or
manufacturing processes, fines, suspension or loss of regulatory approvals or clearances, product
recalls, termination of distribution or product seizures or the need to invest substantial
resources to comply with various existing and new requirements. In the more egregious cases,
criminal sanctions, civil penalties, disgorgement of profits or closure of our manufacturing
facilities are possible. The subsequent discovery of previously unknown problems with Microcyn,
including adverse events of unanticipated severity or frequency, may result in restrictions on the
marketing of our products, and could include voluntary or mandatory recall or withdrawal of
products from the market.
New government regulations may be enacted and changes in FDA policies and regulations,
their interpretation and enforcement, could prevent or delay regulatory approval of our products.
We cannot predict the likelihood, nature or extent of adverse government regulation that may arise
from future legislation or administrative action, either in the United States or abroad. Therefore,
we do not know whether we will be able to continue to comply with any regulations or that the costs
of such compliance will not have a material adverse effect on our future business, financial
condition, and results of operations. If we are not able to maintain regulatory compliance, we will
not be permitted to market our products and our business would suffer.
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We may experience difficulties in manufacturing Microcyn, which could prevent us from
commercializing one or more of our products.
The machines used to manufacture our Microcyn-based products are complex, use complicated
software and must be monitored by highly trained engineers. Slight deviations anywhere in our
manufacturing process, including quality control, labeling and packaging, could lead to a failure
to meet the specifications required by the FDA, the EPA, European notified bodies, Mexican
regulatory agencies and other foreign regulatory bodies, which may result in lot failures or
product recalls. In August 2006, we received a show cause letter from the EPA, which stated that,
in tests conducted by the EPA, Cidalcyn was found to be ineffective in killing specified pathogens
when used according to label directions. We have begun gathering records for review to determine if
there might have been any problems in production of the lot tested by the EPA. We have also
quarantined all remaining quantities of the production lot in question. If we are unable to obtain
quality internal and external components, mechanical and electrical parts, if our software contains
defects or is corrupted, or if we are unable to attract and retain qualified technicians to
manufacture our products, our manufacturing output of Microcyn, or any other product candidate
based on our platform that we may develop, could fail to meet required standards, our regulatory
approvals could be delayed, denied or revoked, and commercialization of one or more of our
Microcyn-based products may be delayed or foregone. Manufacturing processes that are used to
produce the smaller quantities of Microcyn needed for our clinical test and current commercial
sales may not be successfully scaled up to allow production of significant commercial quantities.
Any failure to manufacture our products to required standards on a commercial scale could result in
reduced revenues, delays in generating revenue and increased costs.
Our competitive position depends on our ability to protect our intellectual property and our
proprietary technologies.
Our ability to compete and to achieve and maintain profitability depends on our ability
to protect our intellectual property and proprietary technologies. We currently rely on a
combination of patents, patent applications, trademarks, trade secret laws, confidentiality
agreements, license agreements and invention assignment agreements to protect our intellectual
property rights. We also rely upon unpatented know-how and continuing technological innovation to
develop and maintain our competitive position. These measures may not be adequate to safeguard our
Microcyn technology. In addition, we granted a security interest in our assets, including our intellectual property, under a loan and
security agreement. If we do not protect our rights adequately,
third parties could use our technology, and our ability to compete in the market would be reduced.
Although we have filed U.S. and foreign patent applications related to our Microcyn based
products, the manufacturing technology for making the products, and their uses, only one patent has
been issued from these applications to date.
Our pending patent applications and any patent applications we may file in the future may
not result in issued patents, and we do not know whether any of our in-licensed patents or any
additional patents that might ultimately be issued by the U.S. Patent and Trademark Office or
foreign regulatory body will protect our Microcyn technology.
Any claims that issue may not be sufficiently broad to prevent third parties from producing
competing substitutes and may be infringed, designed around, or invalidated by third parties. Even
issued patents may later be found to be invalid, or may be modified or revoked in proceedings
instituted by third parties before various patent offices or in courts.
The degree of future protection for our proprietary rights is more uncertain in part
because legal means afford only limited protection and may not adequately protect our rights, and
we will not be able to ensure that:
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we were the first to invent the inventions described in patent applications; |
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we were the first to file patent applications for inventions; |
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others will not independently develop similar or alternative technologies or
duplicate our products without infringing our intellectual property rights; |
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any patents licensed or issued to us will provide us with any competitive advantages; |
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we will develop proprietary technologies that are patentable; or |
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the patents of others will not have an adverse effect on our ability to do business. |
The policies we use to protect our trade secrets may not be effective in preventing
misappropriation of our trade secrets by others. In addition, confidentiality and invention
assignment agreements executed by our employees, consultants and advisors may not be enforceable or
may not provide meaningful protection for our trade secrets or other proprietary information in the
event of unauthorized use or disclosures. We cannot be certain that the steps we have taken will
prevent the misappropriation and use of our intellectual property, particularly in foreign
countries where the laws may not protect our proprietary rights as fully as in the United States.
For example, one of our former contract partners, Nofil Corporation, whom we relied upon to
manufacture our proprietary machines had access to our proprietary information and we believe
undertook the development and manufacture of the machines to be sold to third parties in violation
of our agreement with such company. We have brought a claim against Nofil Corporation in the U.S.
District Court for the Northern District of California. We believe that a former officer of our
Mexico subsidiary collaborated in these acts, misappropriated our trade secrets, and is currently
selling products in Mexico that are competitive with our products. In addition, we believe that,
through the licensor of the patents that we in-license and who has also assigned patents to us, a
company in Japan obtained one of our patent applications, translated it into Hangul and filed it
under such companys and the licensors name in South Korea. These and any other leak of
confidential data into the public domain or to third parties could allow our competitors to learn
our trade secrets.
We are in a dispute with the Japanese entity that licenses to us certain rights under Japanese
patents, which could result in our losing such rights and may have a material adverse impact on our
business opportunities in Japan.
In March 2003, we obtained an exclusive license to six issued Japanese patents and five
Japanese published pending patent applications owned by Coherent Technologies. The issued Japanese
patents and pending Japanese patent applications relate to an earlier generation of super-oxidized
water product with an acidic pH and not the current commercialized Microcyn. The patents that cover
the method and apparatus for the production of the earlier generation of super-oxidized water will
expire between 2011 and 2014. In June 2006, we received written notice from Coherent Technologies
advising us that the patent license was terminated, citing various reasons with which we disagree.
Since that time we have engaged Coherent Technologies in discussions concerning the license
agreement and our continued business relationship. Although we do not believe Coherent Technologies
has grounds to terminate the license, we may have to take legal action to preserve our rights under
the license and to enjoin Coherent Technologies from breaching its terms. We do not know whether we
would prevail in any such action, which would be costly and time consuming, and we could lose our
rights under the license, which could have a material adverse impact on our business opportunities
in Japan. In addition, we could have to defend ourselves against infringement claims from Coherent
Technologies in Japan based on their position on termination of the license.
We may face intellectual property infringement claims that could be time-consuming, costly to
defend and could result in our loss of significant rights and, in the case of patent infringement
claims, the assessment of treble damages.
On
occasion, we may receive notices of claims of infringement, misappropriation or
misuse of other parties proprietary rights. We may have disputes regarding intellectual property
rights with the parties that have licensed those rights to us. Some claims received from third
parties may lead to litigation. We cannot assure you that we will prevail in these actions, or that
other actions alleging misappropriation or misuse by us of third-party trade secrets, infringement
by us of third-party patents and trademarks or the validity of our patents, will not be asserted or
prosecuted against us. We may also initiate claims to defend our
intellectual property. For example, we brought a claim against Nofil
Corporation for misappropriation of our trade secrets and Nofil
Corporation filed a cross-complaint against us in February 2007
claiming ownership of our technology.
Intellectual property litigation, regardless of outcome, is expensive and time-consuming, could
divert managements attention from our business and have a material negative effect on our
business, operating results or financial condition. In addition, the
outcome of such litigation may be unpredictable. If there is a successful claim of infringement
against us, we may be required to pay substantial damages (including treble damages if we were to
be found to have willfully infringed a third partys patent) to the party claiming infringement,
develop non-infringing technology, stop selling our products or using technology that contains the
allegedly infringing intellectual property or enter into royalty or license agreements that may not
be available on acceptable or commercially practical terms, if at all. Our failure to develop
non-infringing technologies or license the proprietary
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rights on a timely basis could harm our
business. In addition, modifying our products to include the non-infringing technologies could
require us to seek re-approval or clearance from various regulatory bodies for our products, which
would be costly and time consuming. Also, we may be unaware of pending patent applications that
relate to our technology. Parties making infringement claims on future issued patents may be able
to obtain an injunction that would prevent us from selling our products or using technology that
contains the allegedly infringing intellectual property, which could harm our business.
In September 2005, a complaint was filed against us in Mexico claiming trademark
infringement with respect to our Microcyn60 mark. To settle this claim we have agreed to cease
marketing our product in Mexico under the name Microcyn60 by September 2007. A second unrelated
claim was filed against us in Mexico in May 2006, claiming trademark infringement with respect to
our Microcyn60 mark in Mexico. We are in discussions with the claimant to settle the matter.
In addition to the infringement claims in Mexico, we are currently involved in several
pending trademark opposition proceedings in connection with our applications to register the marks
Microcyn, Oculus Microcyn and Dermacyn in the European Union, Argentina, Guatemala, Honduras,
Nicaragua and Paraguay. If we are unable to settle these disputes or prevail in these opposition
proceedings, we will not be able to obtain registrations for the Microcyn, Oculus Microcyn and
Dermacyn marks in those countries, and that may impair our ability to enforce our trademark rights
against infringers in those countries. Although no such legal proceedings have been brought or
threats of such legal proceedings have been made, we cannot rule out the possibility that any of
these opposing parties will also file a trademark infringement lawsuit seeking to prevent our use
and seek monetary damages based on our use of the Microcyn, Oculus Microcyn and Dermacyn marks in
the European Union, Argentina, Guatemala, Honduras, Nicaragua and Paraguay.
We have also entered into agreements with third parties to settle trademark opposition
proceedings in which we have agreed to certain restrictions on our use and registration of certain
marks. In March 2006, we entered into an agreement with an opposing party that places restrictions
on the manner in which we can use and register our Microcyn and Microcyn60 marks in countries where
the opposing party has superior rights, including in Europe and Singapore. These restrictions
include always using Microcyn along with the word technology and another distinctive trademark
such as Cidalcyn, Dermacyn and Vetericyn. In addition, we have entered into an agreement with an
opposing party in which we agreed to limit our use and registration of the Microcyn mark in Uruguay
to disinfectant, antiseptic and sterilizing agents. Moreover, we have entered into an agreement
with an opposing party in Europe in which we agreed to specifically exclude ophthalmologic products
for our Oculus Microcyn application in the European Union.
Our ability to generate revenue will be diminished if we are unable to obtain acceptable
prices or an adequate level of reimbursement from third-party payors of healthcare costs.
The continuing efforts of governmental and other third-party payors, including managed
care organizations such as health maintenance organizations, or HMOs, to contain or reduce costs of
health care may affect our future revenue and profitability, and the future revenue and
profitability of our potential customers, suppliers and collaborative or license partners and the
availability of capital. For example, in certain foreign markets, pricing or
profitability of prescription pharmaceuticals is subject to government control. In the United
States, governmental and private payors have limited the growth of health care costs through price
regulation or controls, competitive pricing programs and drug rebate programs. Our ability to
commercialize our products successfully will depend in part on the extent to which appropriate
coverage and reimbursement levels for the cost of our Microcyn products and related treatment are
obtained from governmental authorities, private health insurers and other organizations, such as
HMOs.
There is significant uncertainty concerning third-party coverage and reimbursement of
newly approved medical products and drugs. Third-party payors are increasingly challenging the
prices charged for medical products and services. Also, the trend toward managed healthcare in the
United States and the concurrent growth of organizations such as HMOs, as well as legislative
proposals to reform healthcare or reduce government insurance programs, may result in lower prices
for or rejection of our products. The cost containment measures that health care payors and
providers are instituting and the effect of any health care reform could materially and adversely
affect our ability to generate revenues.
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In addition, given ongoing federal and state government initiatives directed at lowering the
total cost of health care, the United States Congress and state legislatures will likely continue
to focus on health care reform, the cost of prescription pharmaceuticals and the reform of the
Medicare and Medicaid payment systems. While we cannot predict whether any proposed
cost-containment measures will be adopted, the announcement or adoption of these proposals could
reduce the price that we receive for our Microcyn products in the future.
We could be required to indemnify third parties for alleged infringement, which could cause us
to incur significant costs.
Some of our distribution agreements contain commitments to indemnify our distributors
against liability arising from infringement of third party intellectual property such as patents.
We may be required to indemnify our customers for claims made against them or license fees they are
required to pay. If we are forced to indemnify for claims or to pay license fees, our business and
financial condition could be substantially harmed.
A significant part of our business is conducted outside of the United States, exposing us to
additional risks that may not exist in the United States, which in turn could cause our business
and operating results to suffer.
We have international operations in Mexico and Europe. For the fiscal years ended March
31, 2004, 2005 and 2006 and the nine months ended December 31, 2006, approximately 10%, 35%, 75%
and 78%, respectively, of our total revenue was generated from sales outside of the United States.
Our business is highly regulated for the use, marketing and manufacturing of our Microcyn products
both domestically and internationally. Our international operations are subject to risks,
including:
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local political or economic instability; |
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changes in governmental regulation; |
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changes in import/export duties; |
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trade restrictions; |
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lack of experience in foreign markets; |
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difficulties and costs of staffing and managing operations in certain foreign countries; |
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work stoppages or other changes in labor conditions; |
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difficulties in collecting accounts receivables on a timely basis or at all; and |
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adverse tax consequences or overlapping tax structures. |
We plan to continue to market and sale our products internationally to respond to
customer requirements and market opportunities. We currently have international manufacturing
facilities in Mexico and The Netherlands. Establishing operations in any foreign country or region
presents risks such as those described above as well as risks specific to the particular country or
region. In addition, until a payment history is established over time with customers in a new
geography or region, the likelihood of collecting receivables generated by such operations could be
less than our expectations. As a result, there is a greater risk that reserves set with respect to
the collection of such receivables may be inadequate. If our operations in any foreign country are
unsuccessful, we could incur significant losses and we may not achieve profitability.
In addition, changes in policies or laws of the United States or foreign governments
resulting in, among other things, changes in regulations and the approval process, higher taxation,
currency conversion limitations, restrictions on fund transfers or the expropriation of private
enterprises, could reduce the anticipated benefits of our international expansion. If we fail to
realize the anticipated revenue growth of our future international operations, our business and
operating results could suffer.
Our sales in international markets subject us to foreign currency exchange and other risks and
costs which could harm our business.
A substantial portion of our revenues are derived from outside the United States,
primarily from Mexico. We anticipate that revenues from international customers will continue to
represent a substantial portion of our revenues
52
for the foreseeable future. Because we generate
revenues in foreign currencies, we are subject to the effects of exchange rate fluctuations. The
functional currency of our Mexican subsidiary is the Mexican Peso, and the functional currency of
our subsidiary in The Netherlands is the Euro. For the preparation of our consolidated financial
statements, the financial results of our foreign subsidiaries are translated into U.S. dollars on
average exchange rates during the applicable period. If the U.S. dollar appreciates against the
Mexican Peso or the Euro, as applicable, the revenues we recognize from sales by our subsidiaries
will be adversely impacted. Foreign exchange gains or losses as a result of exchange rate
fluctuations in any given period could harm our operating results and negatively impact our
revenues. Additionally, if the effective price of our products were to increase as a result of
fluctuations in foreign currency exchange rates, demand for our products could decline and
adversely affect our results of operations and financial condition.
The loss of key members of our senior management team, one of our directors or our inability
to retain highly skilled scientists, technicians and salespeople could adversely affect our
business.
Our success depends largely on the skills, experience and performance of key members of
our executive management team, including Hojabr Alimi, our Chief Executive Officer, and Akihisa
Akao, a member of our Board of Directors and one of our consultants. The efforts of these people
will be critical to us as we continue to develop our products and attempt to commercialize products
in the chronic and acute wound care market. If we were to lose one or more of these individuals, we
may experience difficulties in competing effectively, developing our technologies and implementing
our business strategies.
Our research and development programs depend on our ability to attract and retain highly
skilled scientists and technicians. We may not be able to attract or retain qualified scientists
and technicians in the future due to the intense competition for qualified personnel among medical
technology businesses, particularly in the San Francisco Bay Area. We also face competition from
universities and public and private research institutions in recruiting and retaining highly
qualified personnel. In addition, our success depends on our ability to attract and retain
salespeople with extensive experience in wound care and close relationships with the medical
community, including physicians and other medical staff. We may have difficulties locating,
recruiting or retaining qualified salespeople, which could cause a delay or decline in the rate of
adoption of our products. If we are not able to attract and retain the necessary personnel to
accomplish our business objectives, we may experience constraints that will adversely affect our
ability to support our research, development and sales programs.
We maintain key-person life insurance only on Mr. Alimi. We may discontinue this
insurance in the future, it may not continue to be available on commercially reasonable terms or,
if continued, it may prove inadequate to compensate us for the loss of Mr. Alimis services.
We may be unable to manage our future growth effectively, which would make it difficult to
execute our business strategy.
We may experience periods of rapid growth as we expand our business, which will likely
place a significant strain on our limited personnel and other resources. Any failure by us to
manage our growth effectively could have an adverse effect on our ability to achieve our
commercialization goals.
Furthermore, we conduct business in a number of geographic regions and are seeking to
expand to other regions. We have not established a physical presence in many of the international
regions in which we conduct or plan to conduct business, but rather we manage our business from our
headquarters in Northern California. As a result, we conduct business at all times of the day and
night with limited personnel. If we fail to appropriately target and increase our presence in these
geographic regions, we may not be able to effectively market and sell our Microcyn products in
these locations or we may not meet our customers needs in a timely manner, which could negatively
affect our operating results.
Future growth will also impose significant added responsibilities on management,
including the need to identify, recruit, train and integrate additional employees. In addition,
rapid and significant growth will place strain on our administrative and operational
infrastructure, including sales and marketing and clinical and regulatory personnel. Our ability to
manage our operations and growth will require us to continue to improve our operational, financial
and management controls, reporting systems and procedures. If we are unable to manage our growth
effectively, it may be difficult for us to execute our business strategy.
53
The wound care industry is highly competitive and subject to rapid technological change. If
our competitors are better able to develop and market products that are less expensive or more
effective than any products that we may develop, our commercial opportunity will be reduced or
eliminated.
The wound care industry is highly competitive and subject to rapid technological change.
Our success depends, in part, upon our ability to stay at the forefront of technological change and
maintain a competitive position.
We compete with large healthcare, pharmaceutical and biotechnology companies, along with
smaller or early-stage companies that have collaborative arrangements with larger pharmaceutical
companies, academic institutions, government agencies and other public and private research
organizations. Many of our competitors have significantly greater financial resources and expertise
in research and development, manufacturing, pre-clinical testing, conducting clinical trials,
obtaining regulatory approvals and marketing approved products than we do. Our competitors may:
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develop and patent processes or products earlier than we will; |
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develop and commercialize products that are less expensive or more efficient
than any products that we may develop; |
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obtain regulatory approvals for competing products more rapidly than we will; and |
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improve upon existing technological approaches or develop new or different
approaches that render our technology or products obsolete or non-competitive. |
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As a result, we may not be able to successfully commercialize any future products. |
The success of our research and development efforts may depend on our ability to find suitable
collaborators to fully exploit our capabilities. If we are unable to establish collaborations or if
these future collaborations are unsuccessful, our research and development efforts may be
unsuccessful, which could adversely affect our results of operations and financial condition.
An important element of our business strategy will be to enter into collaborative or
license arrangements under which we license our Microcyn technology to other parties for
development and commercialization. We expect that while we may initially seek to conduct initial
clinical trials on our drug candidates, we may need to seek collaborators for a number of our
potential products because of the expense, effort and expertise required to continue additional
clinical trials and further develop those potential products candidates. Because collaboration
arrangements are complex to negotiate, we may not be successful in our attempts to establish these
arrangements. Also, we may not have products that are desirable to other parties, or we may be
unwilling to license a potential product because the party interested in it is a competitor. The
terms of any arrangements that we establish may not be favorable to us. Alternatively, potential
collaborators may decide against entering into an agreement with us because of our
financial, regulatory or intellectual property position or for scientific, commercial or other
reasons. If we are not able to establish collaborative agreements, we may not be able to develop
and commercialize new products, which would adversely affect our business and our revenues.
In order for any of these collaboration or license arrangements to be successful, we must
first identify potential collaborators or licensees whose capabilities complement and integrate
well with ours. We may rely
on these arrangements for, not only financial resources, but also for expertise or economies of
scale that we expect to need in the future relating to clinical trials, manufacturing, sales and
marketing, and for licenses to technology rights. However, it is likely that we will not be able to
control the amount and timing of resources that our collaborators or licensees devote to our
programs or potential products. If our collaborators or licensees prove difficult to work with, are
less skilled than we originally expected, or do not devote adequate resources to the program, the
relationship will not be successful. If a business combination, involving a collaborator or
licensee and a third party were to occur, the effect could be to diminish, terminate or cause
delays in development of a potential product.
We may acquire other businesses or form joint ventures that could harm our operating results,
dilute your ownership of us, increase our debt or cause us to incur significant expense.
As part of our business strategy, we may pursue acquisitions of complementary businesses
and assets, as well as technology licensing arrangements. We also intend to pursue strategic
alliances that leverage our core technology
54
and industry experience to expand our product offerings
or distribution. We have no experience with respect to acquiring other companies and limited
experience with respect to the formation of collaborations, strategic alliances and joint ventures.
If we make any acquisitions, we may not be able to integrate these acquisitions successfully into
our existing business, and we could assume unknown or contingent liabilities. Any future
acquisitions by us also could result in significant write-offs or the incurrence of debt and
contingent liabilities, any of which could harm our operating results. Integration of an acquired
company also may require management resources that otherwise would be available for ongoing
development of our existing business. We may not identify or complete these transactions in a
timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated
benefits of any acquisition, technology license, strategic alliance or joint venture.
To finance any acquisitions, we may choose to issue shares of our common stock as
consideration, which would dilute your ownership interest in us. If the price of our common stock
is low or volatile, we may not be able to acquire other companies for stock. Alternatively, it may
be necessary for us to raise additional funds for acquisitions through public or private
financings. Additional funds may not be available on terms that are favorable to us, or at all.
If we are unable to comply with broad and complex federal and state fraud and abuse laws,
including state and federal anti-kickback laws, we could face substantial penalties and our
products could be excluded from government healthcare programs.
We are subject to various federal and state laws pertaining to healthcare fraud and
abuse, which include, among other things, anti-kickback laws that prohibit payments to induce the
referral of products and services, and false claims statutes that prohibit the fraudulent billing
of federal healthcare programs. Our operations are subject to the federal anti-kickback statute, a
criminal statute that, subject to certain statutory exceptions, prohibits any person from knowingly
and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, to
induce or reward a person either (i) for referring an individual for the furnishing of items or
services for which payment may be made in whole or in part by a government healthcare program such
as Medicare or Medicaid, or (ii) for purchasing, leasing, or ordering or arranging for or
recommending the purchasing, leasing or ordering of an item or service for which payment may be
made under a government healthcare program. Because of the breadth of the federal anti-kickback
statute, the Office of Inspector General of the U.S. Department of Health and Human Services, or
the OIG, was authorized to adopt regulations setting forth additional exceptions to the
prohibitions of the statute commonly known as safe harbors. If all of the elements of an
applicable safe harbor are fully satisfied, an arrangement will not be subject to prosecution under
the federal anti-kickback statute.
We have agreements to pay compensation to our advisory board members and physicians who
conduct clinical trials or provide other services for us. The agreements may be subject to
challenge to the extent they do not fall within relevant safe harbors under federal and similar
state anti-kickback laws. If our past or present operations, including, but not limited to, our
consulting arrangements with our advisory board members or physicians conducting clinical trials on
our behalf, or our promotional or discount programs, are found to be in violation of
these laws, we or our officers may be subject to civil or criminal penalties, including large
monetary penalties, damages, fines, imprisonment and exclusion from government healthcare program
participation, including Medicare and Medicaid.
In addition, if there is a change in law, regulation or administrative or judicial
interpretations of these laws, we may have to change our business practices or our existing
business practices could be challenged as unlawful, which could have a negative effect on our
business, financial condition and results of operations.
Healthcare fraud and abuse laws are complex and even minor, inadvertent irregularities
can potentially give rise to claims that a statute or regulation has been violated.
The frequency of suits to enforce these laws have increased significantly in recent years
and have increased the risk that a healthcare company will have to defend a false claim action, pay
fines or be excluded from the Medicare, Medicaid or other federal and state healthcare programs as
a result of an investigation arising out of such action. We cannot assure you that we will not
become subject to such litigation. Any violations of these laws, or any action against us for
violation of these laws, even if we successfully defend against it, could harm our reputation, be
costly to defend and divert managements attention from other aspects of our business. Similarly,
if the physicians or other providers or entities with whom we do business are found to have
violated abuse laws, they may be subject to sanctions, which could also have a negative impact on
us.
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Our efforts to discover and develop potential products may not lead to the discovery,
development, commercialization or marketing of actual drug products.
We are currently engaged in a number of different approaches to discover and develop new
product applications and product candidates. At the present time, we have one Microcyn-based drug
candidate in clinical trials. We also have a non-Microcyn-based compound in the research and
development phase. We believe this compound has potential applications in oncology. Discovery and
development of potential drug candidates are expensive and time-consuming, and we do not know if
our efforts will lead to discovery of any drug candidates that can be successfully developed and
marketed. If our efforts do not lead to the discovery of a suitable drug candidate, we may be
unable to grow our clinical pipeline or we may be unable to enter into agreements with
collaborators who are willing to develop our drug candidates.
We must implement additional and expensive finance and accounting systems, procedures and
controls as we grow our business and organization and to satisfy new reporting requirements, which
will increase our costs and require additional management resources.
As a public reporting company, we will be required to comply with the Sarbanes-Oxley Act
of 2002 and the related rules and regulations of the Securities and Exchange Commission, or the
Commission, including expanded disclosures and accelerated reporting requirements and more complex
accounting rules. Compliance with Section 404 of the Sarbanes-Oxley Act of 2002 and other
requirements will increase our costs and require additional management resources. In a letter
following their dismissal, our prior independent auditors informed us that we did not have the
appropriate financial management and reporting structure in place to meet the demands of a public
company and that our accounting and financial personnel lacked the appropriate level of accounting
knowledge, experience and training. We recently have been upgrading our finance and accounting
systems, procedures and controls and will need to continue to implement additional finance and
accounting systems, procedures and controls as we grow our business and organization, enter into
complex business transactions and take actions designed to satisfy new reporting requirements.
Specifically, our experience with QP indicated that we need to better plan for complex transactions
and the application of complex accounting principles relating to those transactions. If we are
unable to complete the required Section 404 assessment as to the adequacy of our internal control
over financial reporting, if we fail to maintain or implement adequate controls, or if our
independent registered public accounting firm is unable to provide us with an unqualified report as
to the effectiveness of our internal control over financial reporting as of the date of our second
Annual Report on Form 10-K for which compliance is required and thereafter, our ability to obtain
additional financing could be impaired. In addition, investors could lose confidence in the
reliability of our internal control over financial reporting and in the accuracy of our periodic
reports filed under the Securities Exchange Act of 1934. A lack of investor confidence in the
reliability and accuracy of our public reporting could cause our stock price to decline.
We may not be able to maintain sufficient product liability insurance to cover claims against us.
Product liability insurance for the healthcare industry is generally expensive to the
extent it is available at all. We may not be able to maintain such insurance on acceptable terms or
be able to secure increased coverage if the commercialization of our products progresses, nor can
we be sure that existing or future claims against us will be covered by our product liability
insurance. Moreover, the existing coverage of our insurance policy or any rights of indemnification
and contribution that we may have may not be sufficient to offset existing or future claims. A
successful claim against us with respect to uninsured liabilities or in excess of insurance
coverage and not subject to any indemnification or contribution could have a material adverse
effect on our future business, financial condition, and results of operations.
Risks Related to Our Common Stock
Our operating results may fluctuate, which could cause our stock price to decrease.
Fluctuations in our operating results may lead to fluctuations, including declines, in
our share price. Our operating results and our share price may fluctuate from period to period due
to a variety of factors, including:
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demand by physicians, other medical staff and patients for our Microcyn products; |
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reimbursement decisions by third-party payors and announcements of those decisions; |
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clinical trial results and publication of results in peer-reviewed journals or the presentation
at medical conferences; |
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the inclusion or exclusion of our Microcyn products in large clinical trials conducted by others; |
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actual and anticipated fluctuations in our quarterly financial and operating results; |
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developments or disputes concerning our intellectual property or other proprietary rights; |
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issues in manufacturing our product candidates or products; |
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new or less expensive products and services or new technology introduced or offered by our
competitors or us; |
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the development and commercialization of product enhancements; |
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changes in the regulatory environment; |
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delays in establishing new strategic relationships; |
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introduction of technological innovations or new commercial products by us or our competitors; |
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litigation or public concern about the safety of our product candidates or products; |
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changes in recommendations of securities analysts or lack of analyst coverage; |
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failure to meet analyst expectations regarding our operating results; |
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additions or departures of key personnel; and |
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general market conditions. |
Variations in the timing of our future revenues and expenses could also cause significant
fluctuations in our operating results from period to period and may result in unanticipated earning
shortfalls or losses. In addition, the Nasdaq Global Market, in general, and the market for life
sciences companies, in particular, have experienced
significant price and volume fluctuations that have often been unrelated or disproportionate
to the operating performance of those companies.
If an active, liquid trading market for our common stock does not develop, you may not be able
to sell your shares quickly or at or above the initial offering price.
Prior to our initial public offering, there has not been a public market for our common
stock. Although we have applied to have our common stock listed on the Nasdaq Global Market, an
active and liquid trading market for our common stock may not develop or be sustained following our
initial public offering. You may not be able to sell your shares quickly or at or above the initial
offering price if trading in our stock is not active. The initial public offering price may not be
indicative of prices that will prevail in the trading market.
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Future sales of shares by our stockholders could cause the market price of our common stock to
drop significantly, even if our business is doing well.
We
currently have 11,753,334 outstanding shares of common stock-based on the number of
shares outstanding at December 31, 2006 on a pro-forma basis. This includes the 3,025,000 shares that we sold in our
initial public offering, and 328,550 shares we sold in connection with the underwriters
partial exercise of their over-allotment option, which (other than shares purchased by our affiliates) may be resold in the
public market immediately. The remaining shares will become available for resale in the public
market as shown in the chart below.
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Number of Restricted Shares and % of |
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Total Outstanding Following Offering |
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Date Available for Sale Into Public Market |
229,025 shares, or 2%
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Immediately |
7,976,604
shares, or 68%
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Immediately upon expiration of
the 180-day lock up period |
193,580 shares, or 2%
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At some point after expiration
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We do not expect to pay dividends in the foreseeable future. As a result, you must rely on stock
appreciation, if any, for a return on your investment.
We do not anticipate paying cash dividends on our common stock in the foreseeable future.
Any payment of cash dividends will also depend on our financial condition, results of operations,
capital requirements and other factors and will be at the discretion of our Board of Directors.
Accordingly, you will have to rely on appreciation in the price of our common stock, if any, to
earn a return on your investment in our common stock. Furthermore, we may in the future become
subject to contractual restrictions on, or prohibitions against, the payment of dividends.
We may allocate net proceeds from our initial public offering in ways with which you may not
agree.
Our management will have broad discretion in using the proceeds from our initial public
offering and may use the proceeds in ways with which you may disagree. Because we are not required
to allocate the net proceeds from the offering to any specific investment or transaction, you
cannot determine at this time the value or propriety of our application of the proceeds. Moreover,
you will not have the opportunity to evaluate the economic, financial or other information on which
we base our decisions on how to use our proceeds. We may use the proceeds for corporate
purposes that do not immediately enhance our prospects for the future or increase the value of
your investment. As a result, you and other stockholders may not agree with our decisions.
Anti-takeover provisions in our charter, by-laws and Delaware law may make it more difficult for
you to change our management and may also make a takeover difficult.
Our corporate documents and Delaware law contain provisions that limit the ability of
stockholders to change our management and may also enable our management to resist a takeover.
These provisions include:
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the ability of our Board of Directors to issue and designate the rights of,
without stockholder approval, up to 5,000,000 shares of preferred stock, which
rights could be senior to those of common stock; |
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limitations on persons authorized to call a special meeting of stockholders; and |
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advance notice procedures required for stockholders to make nominations of
candidates for election as directors or to bring matters before an annual
meeting of stockholders. |
These provisions might discourage, delay or prevent a change of control in our
management. These provisions could also discourage proxy contests and make it more difficult for
you and other stockholders to elect directors and cause us to take other corporate actions. In
addition, the existence of these provisions, together with Delaware law, might hinder or delay an
attempted takeover other than through negotiations with our Board of Directors.
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Our stockholders may experience substantial dilution in the value of their investment if we
issue additional shares of our capital stock.
Our charter documents allow us to issue up to 100,000,000 shares of our common stock and to
issue and designate the rights of, without stockholder approval, up to 5,000,000 shares of
preferred stock. In the event we issue additional shares of our capital stock, dilution to our
stockholders could result. In addition, if we issue and designate a class of preferred stock, these
securities may provide for rights, preferences or privileges senior to those of holders of our
common stock.
Item 2. Unregistered Sales of Securities and Use of Proceeds
The following information gives effect to our one-for-four reverse stock split effected on December
15, 2006.
Exercises of Stock Options
On various dates between January 14, 2002 and December 31, 2006, we sold 333,729 shares of our
common stock to employees and directors pursuant to the exercise of options granted under our 1999,
2000, 2003 and 2004 stock plans. The exercise prices per share ranged from $0.12 to $3.00, for an
aggregate consideration of $297,585.
The sales of the above securities were considered to be exempt from registration under the
Securities Act in reliance on Rule 701 promulgated under Section 3(b) of the Securities Act, as
transactions under compensatory benefit plans and contracts relating to compensation as provided
under Rule 701. The sale of the above securities in a 12 months period did not exceed the greater
of (a) $1,000,000, (b) 15% of total assets as of our most recent balance sheet or (c) 15% of the
number of outstanding shares of our common stock sold in reliance on this Rule.
Issuances of Capital Stock in Financing Rounds
In
September and October 2006, we sold 193,045 units, consisting of 193,045 shares of Series C
convertible preferred stock at a per unit price of $18.00, and warrants to purchase 38,604 shares
of common stock at $18.00 per share, for aggregate gross proceeds of
$3,474,000 to one qualified
institutional buyer and one institutional accredited investor. In connection with this sale, we
paid to Brookstreet, as placement agent, an aggregate of $347,000 in
commissions and issued to Brookstreet Securities Corporation fully vested warrants to purchase an aggregate of 24,128
shares of our common stock.
The sales of the above securities were considered to be exempt from registration under the
Securities Act in reliance on Rule 506 of Regulation D promulgated under the Securities Act, as
transactions by an issuer not involving a public offering. The purchasers of these securities were
qualified institutional buyers or institutional accredited investors, represented their intention
to acquire the securities for investment only and not with a view to or for sale with any
distribution thereof, and appropriate legends were affixed to the share certificates and
instruments issued in the transaction. All purchasers had adequate access, through their
relationship with us, to information about the Company.
Issuance of Securities to Consultant
In November 2006, we issued a warrant to purchase an aggregate of 75,000 shares of our common
stock at an exercise price equal to the price per share of our common stock in our initial public
offering, which, for purposes of this disclosure, we assumed to be the midpoint of $9.00 per share,
to a consultant providing consulting services for us. The warrant was cancelled in January 2007 and
a new warrant, having an exercise price of $8.00 per share but otherwise having terms identical to
the original warrant, was issued to the consultant. The sale of these securities was considered to
be exempt from registration under the Securities Act in reliance on Rule 506 of Regulation D
promulgated under the Securities Act, as a transaction by an issuer not involving a public
offering. The purchaser is an accredited investor, who represented his intention to acquire the
securities for investment only and not with a view to sell with any distribution thereof, and
appropriate legends were affixed to the instruments issued in the transaction. The purchaser had
access, through its relationship with us, to information about the Company.
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Issuance of Securities for Finders Fee
In November 2006, we signed a loan agreement with Robert Burlingame, one of our directors,
under which Mr. Burlingame advanced to us $4.0 million, which accrues interest at an annual rate of
7% (the Bridge Loan). The principal and all accrued interest under the loan agreement, which is
available to us as working capital, will become due and payable in full on November 10, 2007. The
loan is secured by all of our assets, other than our intellectual property, but is subordinate to
the security interest in all of our assets, including our intellectual property, held by our
secured lender. In connection with this Bridge Loan, we paid to Brookstreet, as finder, a fee in
the amount of $50,000 and granted Brookstreet a warrant to purchase 25,000 shares of the our common
stock at an exercise price of $18.00 per share. The sale of the above securities was considered to
be exempt from registration under the Securities Act in reliance on Rule 506 of Regulation D
promulgated under the Securities Act, as transactions by an issuer not involving a public offering.
The purchaser of the securities was an accredited investor, represented its intention to acquire
the securities for investment only and not with a view to or for sale with any distribution
thereof, and appropriate legends were affixed to the share certificates and instruments issued in
the transaction. The purchaser had adequate access, through its relationship with the us, to
information about the Company.
Initial Public Offering
The
Companys Registration Statement on Form S-1, Amendment No. 7, (File No. 333-135584) related to our initial
public offering was declared effective by the SEC on January 24, 2007. A total of 3,025,000 shares
of the Companys Common Stock were registered with the SEC. All of these shares were registered on
the Companys behalf. The offering commenced on January 25, 2007 and 3,025,000 shares of common
stock offered were sold on January 30, 2007 for an aggregate offering price of $22.3 million
through the managing underwriters: Roth Capital Partners, Maxim LLC and Brookstreet Securities
Corporation.
The Company paid to the underwriters underwriting discounts, commissions and non-accountable
expenses totaling $1.9 million in connection with the initial public offering. In addition, the
Company incurred or may incur additional expenses of approximately $2.8 million in connection with
the initial public offering, which when added to the underwriting discounts, commissions and
non-accountable expenses paid by the Company amounts to total expenses of $4.7 million. Thus the
net offering proceeds to the Company (after deducting underwriting
discounts, commissions non-accountable expenses and estimated
offering expenses to be paid by the us) were approximately $19.5 million. No offering expenses were paid directly
or indirectly to any of the Companys directors or officers (or their associates), persons
owning ten percent (10%) or more of any class of the Companys equity securities or to any other
affiliates.
All of the net proceeds from the initial public offering were received on January 30, 2007,
after the close of the quarter. All net proceeds have been invested in interest bearing,
investment-grade securities. We have used the net proceeds of the public offering primarily for
general corporate purposes. We intend to use the net proceeds from the initial public offering to
finance our sales and marketing capabilities, our clinical trials and related research, and for
general corporate purposes. The amounts and timing of our actual expenditures will depend upon
numerous factors, including our sales and marketing activities, status of our clinical trials and
related research and the amount of cash generated by our operations, if any.
On February 16, 2007 the underwriters of the Companys initial public offering exercised their
option to purchase 328,550 shares of the over-allotment of the Companys common stock per the terms
of our underwriting agreement. This purchase of common stock raised net proceeds of $2.4 million
after deducting underwriting discounts, commissions, and non-accountable expenses.
60
Item 4. Submission of Matters to a Vote of the Security Holders
On December 14, 2006, the shareholders of Oculus Innovative Sciences, Inc., a California
corporation (the California Corporation), acted by written consent.
|
|
|
|
|
|
|
|
|
|
|
|
|
Vote Solicited |
|
For |
|
|
Against |
|
|
Abstain |
|
Approve Reincorporation from
California to Delaware |
|
|
5,720,139 |
|
|
|
54,278 |
|
|
|
114,912 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Approve a 1-for-4 reverse stock split |
|
|
5,718,056 |
|
|
|
54,278 |
|
|
|
116,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Approve form of Restated Certificate
of Incorporation to be filed with the
Secretary of State for the State of
Delaware contemporaneously with the
closing of the Companys initial
public offering |
|
|
5,716,417 |
|
|
|
45,500 |
|
|
|
127,412 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorize OIS Reincorporation Sub,
Inc., the Delaware company into which
the California Corporation was merged,
to enter into indemnification
agreements with its directors and
certain of its officers |
|
|
5,626,903 |
|
|
|
66,528 |
|
|
|
195,898 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Approve the adoption of our 2006 Stock
Incentive Plan |
|
|
5,710,111 |
|
|
|
59,140 |
|
|
|
129,079 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Elect and ratify the appointment of
Robert Burlingame as the Series A
Convertible preferred stock director
(Series A class vote) |
|
|
703,968 |
|
|
|
9,167 |
|
|
|
22,917 |
|
|
|
|
|
|
|
|
|
|
Vote Solicited |
|
Waive |
|
|
Do Not Waive |
|
Waive any anti-dilution rights and rights of
first refusal that could be applicable to the
issuance of a warrant to purchase shares of the
Companys common stock as a part of a
settlement of litigation filed against the
Company |
|
|
5,702,823 |
|
|
|
186,506 |
|
|
|
|
|
|
Acknowledge |
|
|
|
|
Vote Solicited |
|
and Agree |
|
|
Do Not Agree |
|
Acknowledge and agree to the lock-up
provisions requested by the underwriter in
the Companys initial public offering and
the substitution of Roth Capital Partners as
the representative of the underwriters |
|
|
5,634,107 |
|
|
|
255,233 |
|
There were no broker non-votes.
The terms in office as directors of Hojabr Alimi, Akihisa Akao, Richard Conley, Greg French, Edward
Brown and James Schutz continued after the meeting.
61
Item 6. Exhibits
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
31.1
|
|
|
Rule 13a-14(a) Certification of Chief Executive Officer |
|
|
|
|
31.2
|
|
|
Rule 13a-14(a) Certification of Chief Financial Officer |
|
|
|
|
32.1#
|
|
|
Statement of Chief Executive Officer under Section 906 of the
Sarbanes-Oxley Act of 2002 (18 U.S.C. §1350) |
|
|
|
|
32.2#
|
|
|
Statement of Chief Financial Officer under Section 906 of the
Sarbanes-Oxley Act of 2002 (18 U.S.C. §1350) |
|
|
|
# |
|
In accordance with Item 601(b)(32)(ii) of Regulation SK and SEC Release Nos. 33-8238 and
34-47986, Final Rule: Managements Reports on Internal Control Over Financial Reporting and
Certification of Disclosure in Exchange Act Periodic Reports, the certifications furnished in
Exhibits 32.1 and 32.2 hereto are deemed to accompany this Form 10-Q and will not be deemed filed
for purposes of Section 18 of the Exchange Act. Such certifications will not be deemed to be
incorporated by reference into any filing under the Securities Act. |
62
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the undersigned thereunto duly
authorized.
|
|
|
|
|
|
Oculus Innovative Sciences, Inc.
|
|
|
By: |
/s/ Hojabr Alimi
|
|
Date: February 21, 2007 |
|
Hojabr Alimi |
|
|
Its: |
Chairman of the Board of Directors and
Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
|
|
|
|
|
|
By: |
/s/ Robert Miller
|
|
Date: February 21, 2007 |
|
Robert Miller |
|
|
Its: |
Chief Financial Officer
(Principal Financial
Officer and Accounting Officer) |
|
|
63
EXHIBIT
INDEX
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
31.1
|
|
|
Rule 13a-14(a) Certification of Chief Executive Officer |
|
|
|
|
31.2
|
|
|
Rule 13a-14(a) Certification of Chief Financial Officer |
|
|
|
|
32.1#
|
|
|
Statement of Chief Executive Officer under Section 906 of the
Sarbanes-Oxley Act of 2002 (18 U.S.C. §1350) |
|
|
|
|
32.2#
|
|
|
Statement of Chief Financial Officer under Section 906 of the
Sarbanes-Oxley Act of 2002 (18 U.S.C. §1350) |
|
|
|
# |
|
In accordance with Item 601(b)(32)(ii) of Regulation SK and SEC Release Nos. 33-8238 and
34-47986, Final Rule: Managements Reports on Internal Control Over Financial Reporting and
Certification of Disclosure in Exchange Act Periodic Reports, the certifications furnished in
Exhibits 32.1 and 32.2 hereto are deemed to accompany this Form 10-Q and will not be deemed filed
for purposes of Section 18 of the Exchange Act. Such certifications will not be deemed to be
incorporated by reference into any filing under the Securities Act. |