Sonoma Pharmaceuticals, Inc. - Quarter Report: 2009 September (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2009
or
o | 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)
Delaware | 68-0423298 | |
(State or other jurisdiction of | (I.R.S Employer | |
incorporation or organization) | Identification No.) |
1129 N. McDowell Blvd.
Petaluma, CA 94954
(Address of principal executive offices) (Zip Code)
Petaluma, CA 94954
(Address of principal executive offices) (Zip Code)
(707) 782 0792
Registrants telephone number, including area code
Registrants telephone number, including area code
Indicate by checkmark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate website, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or
for such shorter period that the registrant was required to submit and post such files). Yes
o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of November 9, 2009 the number of shares outstanding of the registrants common stock, $0.0001
par value, was 24,542,931.
OCULUS INNOVATIVE SCIENCES, INC.
Index
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OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
PART I: FINANCIAL INFORMATION
Item 1. Financial Statements
September 30, | March 31, | |||||||
2009 | 2009 | |||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 6,452 | $ | 1,921 | ||||
Accounts receivable, net |
1,022 | 923 | ||||||
Inventories, net |
505 | 340 | ||||||
Prepaid expenses and other current assets |
611 | 758 | ||||||
Total current assets |
8,590 | 3,942 | ||||||
Property and equipment, net |
1,273 | 1,432 | ||||||
Other assets |
107 | 73 | ||||||
Total assets |
$ | 9,970 | $ | 5,447 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,129 | $ | 1,565 | ||||
Accrued expenses and other current liabilities |
988 | 853 | ||||||
Current portion of long-term debt |
98 | 255 | ||||||
Current portion of capital lease obligations |
2 | 6 | ||||||
Total current liabilities |
2,217 | 2,679 | ||||||
Deferred revenue |
377 | 425 | ||||||
Long-term debt, less current portion |
107 | 74 | ||||||
Derivative liability |
1,080 | | ||||||
Total liabilities |
3,781 | 3,178 | ||||||
Commitments and Contingencies |
||||||||
Stockholders Equity: |
||||||||
Convertible preferred stock, $0.0001 par
value; 5,000,000 shares authorized, no shares
issued and outstanding at September 30, 2009
(unaudited) and March 31, 2009 |
| | ||||||
Common stock, $0.0001 par value; 100,000,000
shares authorized, 24,542,931 and 18,402,820
shares issued and outstanding at September
30, 2009 (unaudited) and March 31, 2009,
respectively |
2 | 2 | ||||||
Additional paid-in capital |
123,367 | 113,803 | ||||||
Accumulated other comprehensive loss |
(2,941 | ) | (3,054 | ) | ||||
Accumulated deficit |
(114,239 | ) | (108,482 | ) | ||||
Total stockholders equity |
6,189 | 2,269 | ||||||
Total liabilities and stockholders equity |
$ | 9,970 | $ | 5,447 | ||||
See accompanying notes
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OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Revenues |
||||||||||||||||
Product |
$ | 1,403 | $ | 1,212 | $ | 2,970 | $ | 2,219 | ||||||||
Service |
269 | 269 | 549 | 473 | ||||||||||||
Total revenues |
1,672 | 1,481 | 3,519 | 2,692 | ||||||||||||
Cost of revenues |
||||||||||||||||
Product |
601 | 446 | 1,128 | 884 | ||||||||||||
Service |
258 | 251 | 473 | 449 | ||||||||||||
Total cost of revenues |
859 | 697 | 1,601 | 1,333 | ||||||||||||
Gross profit |
813 | 784 | 1,918 | 1,359 | ||||||||||||
Operating expenses |
||||||||||||||||
Research and development |
583 | 2,367 | 1,304 | 4,688 | ||||||||||||
Selling, general and administrative |
2,485 | 5,262 | 5,170 | 8,590 | ||||||||||||
Total operating expenses |
3,068 | 7,629 | 6,474 | 13,278 | ||||||||||||
Loss from operations |
(2,255 | ) | (6,845 | ) | (4,556 | ) | (11,919 | ) | ||||||||
Interest expense |
(3 | ) | (149 | ) | (7 | ) | (311 | ) | ||||||||
Interest income |
| 56 | 1 | 132 | ||||||||||||
Income (loss) on derivative instruments |
451 | | (757 | ) | | |||||||||||
Other (expense) income, net |
(86 | ) | 26 | (115 | ) | (13 | ) | |||||||||
Net loss |
$ | (1,893 | ) | $ | (6,912 | ) | $ | (5,434 | ) | $ | (12,111 | ) | ||||
Net loss per common share: basic and diluted |
$ | (0.08 | ) | $ | (0.43 | ) | $ | (0.26 | ) | $ | (0.76 | ) | ||||
Weighted-average number of shares used in per common share calculations: |
||||||||||||||||
Basic and diluted |
22,750 | 15,924 | 21,078 | 15,924 | ||||||||||||
Other comprehensive loss, net of tax |
||||||||||||||||
Net loss |
$ | (1,893 | ) | $ | (6,912 | ) | $ | (5,434 | ) | $ | (12,111 | ) | ||||
Foreign currency translation adjustments |
42 | (207 | ) | 113 | (189 | ) | ||||||||||
Other comprehensive loss |
$ | (1,851 | ) | $ | (7,119 | ) | $ | (5,321 | ) | $ | (12,300 | ) | ||||
See accompanying notes
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OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Six Months Ended | ||||||||
September 30, | ||||||||
2009 | 2008 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (5,434 | ) | $ | (12,111 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
237 | 444 | ||||||
Stock-based compensation |
906 | 1,911 | ||||||
Change in fair value of derivative liability |
757 | | ||||||
Non-cash interest expense |
| 214 | ||||||
Foreign currency transaction losses (gains) |
26 | (60 | ) | |||||
Loss on disposal of assets |
125 | 217 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
(42 | ) | (165 | ) | ||||
Inventories |
(148 | ) | (25 | ) | ||||
Prepaid expenses and other current assets |
172 | 395 | ||||||
Accounts payable |
(11 | ) | (1,676 | ) | ||||
Accrued expenses and other liabilities |
57 | (809 | ) | |||||
Net cash used in operating activities |
(3,355 | ) | (11,665 | ) | ||||
Cash flows from investing activities: |
||||||||
Change in restricted cash |
23 | |||||||
Change in long-term deposits |
(33 | ) | | |||||
Purchases of property and equipment |
(68 | ) | (276 | ) | ||||
Net cash used in investing activities |
(101 | ) | (253 | ) | ||||
Cash flows from financing activities: |
||||||||
Proceeds from the issuance of common stock, net of offering costs |
7,159 | 36 | ||||||
Proceeds from the exercise of common stock options and warrants |
1,053 | | ||||||
Principal payments on debt |
(224 | ) | (940 | ) | ||||
Payments on capital lease obligations |
(4 | ) | (14 | ) | ||||
Net cash provided by (used in) financing activities |
7,984 | (918 | ) | |||||
Effect of exchange rate on cash and cash equivalents |
3 | (15 | ) | |||||
Net increase (decrease) in cash and cash equivalents |
4,531 | (12,851 | ) | |||||
Cash and equivalents, beginning of period |
1,921 | 18,823 | ||||||
Cash and equivalents, end of period |
$ | 6,452 | $ | 5,972 | ||||
Supplemental disclosure of cash flow information: |
||||||||
Cash paid for interest |
$ | 7 | $ | 105 | ||||
Equipment financed |
$ | 100 | $ | | ||||
Obligations settled with stock |
$ | 447 | $ | | ||||
See accompanying notes
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OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
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 treat infections in
chronic and acute wounds. The Companys platform technology, called Microcyn, is a proprietary
oxychlorine small molecule formulation that is designed to treat a wide range of organisms that
cause disease, or pathogens, including viruses, fungi, spores and antibiotic resistant strains of
bacteria. The Company conducts its business worldwide, with significant subsidiaries in Europe and
Mexico.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements as of September 30,
2009 and for the three and six months then ended have been prepared in accordance with the
accounting principles generally accepted in the United States of America for interim financial
information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the
Securities and Exchange Commission (SEC) and on the same basis as the annual audited consolidated
financial statements. The unaudited condensed consolidated balance sheet as of September 30, 2009,
condensed consolidated statements of operations for the three and six months ended September 30,
2009 and 2008, and the condensed consolidated statements of cash flows for the six months ended
September 30, 2009 and 2008 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 six months ended September 30, 2009 are not necessarily indicative of results to be
expected for the year ending March 31, 2010 or for any future interim period. The condensed
consolidated balance sheet at March 31, 2009 has been derived from audited consolidated financial
statements. However, it does not include all of the information and notes required by accounting
principles generally accepted in the United States of America for complete consolidated financial
statements. The accompanying condensed consolidated financial statements should be read in
conjunction with the consolidated financial statements for the year ended March 31, 2009, and notes
thereto included in the Companys Form 10-K, which was filed with the SEC on June 11, 2009.
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosures of
contingent liabilities at the dates of the condensed consolidated financial statements and the
reported amounts of revenues and expenses during the reporting periods. Periodically, the Company
evaluates and adjusts estimates accordingly. The allowance for uncollectible accounts receivable
balances amounted to $62,000 and $51,000, which are included in accounts receivable, net in the
accompanying September 30, 2009 and March 31, 2009 condensed consolidated balance sheets,
respectively.
Foreign Currency Reporting
The consolidated financial statements are presented in United States Dollars in accordance
with FASB Accounting Standards Codification (ASC) 830 Foreign Currency Matters. Accordingly,
the Companys subsidiaries, Oculus Technologies of Mexico, S.A. de C.V. (OTM) uses the local
currency (Mexican Pesos) as its functional currency, and Oculus Innovative Sciences Netherlands,
B.V. (OIS Europe) uses the local currency (Euro) as its functional currency. Assets and
liabilities are translated at exchange rates in effect at the balance sheet date, and revenue and
expense accounts are translated at average exchange rates during the period. Resulting translation
adjustments were recorded in accumulated other comprehensive loss in the accompanying condensed
consolidated balance sheets at September 30, 2009 and March 31, 2009.
Foreign currency transaction gains (losses) relate primarily to trade payables and receivables
between subsidiaries OTM and OIS Europe. These transactions are expected to be settled in the
foreseeable future. The Company recorded foreign currency transaction gains (losses) of $26,000
and $(60,000) for the three months ended September 30, 2009 and 2008, respectively. The related
gains
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(losses) were recorded in other income (expense) in the accompanying condensed consolidated
statements of operations. Loans made to its subsidiaries OTM and OIS Europe are expected be paid
back to the Company as cash flows sufficient to repay the loans are generated.
Net Loss per Share
The Company computes net loss per share in accordance with ASC 260 Earnings per Share, 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 for the three months ended September 30, 2009 and 2008,
excludes potentially dilutive securities because their inclusion would be anti-dilutive.
The following securities were excluded from basic and diluted net loss per share calculation
because their inclusion would be anti-dilutive (in thousands):
September 30, | ||||||||
2009 | 2008 | |||||||
Options to purchase common stock |
3,219 | 2,631 | ||||||
Restricted stock units |
30 | 60 | ||||||
Warrants to purchase common stock |
10,624 | 3,321 | ||||||
13,873 | 6,012 | |||||||
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 applicable provisions of ASC 815
Derivatives and Hedging (ASC 815). Based on the provisions of ASC 815, 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). The Company assesses classification of its freestanding derivatives at each reporting
date to determine whether a change in classification between assets and liabilities is required.
The Company determined that its freestanding derivatives, which principally consist of warrants to
purchase common stock, satisfied the criteria for classification as equity instruments at September
30, 2009 and March 31, 2009 other than certain warrants that contain reset provisions that the
Company classified as derivative liabilities as more fully described in Note 5.
Fair Value of Financial Assets and Liabilities
Financial instruments, including cash and cash equivalents, accounts payable and accrued
liabilities are carried at cost, which management believes approximates fair value due to the
short-term nature of these instruments. The fair value of capital lease obligations and equipment
loans approximates its carrying amounts as a market rate of interest is attached to their
repayment.
The Company measures the fair value of financial assets and liabilities based on the guidance
of ASC 820 Fair Value Measurements and Disclosures which defines fair value, establishes a
framework for measuring fair value, and expands disclosures about fair value measurements on April
1, 2009, the Company adopted the new standard for financial assets and liabilities, as well as for
any other assets and liabilities that are carried at fair value on a recurring basis.
The standard defines fair value as the exchange price that would be received for an asset or
paid to transfer a liability (an exit price) in the principal or most advantageous market for the
asset or liability in an orderly transaction between market participants on the measurement date.
The standard also establishes a fair value hierarchy, which requires an entity to maximize the use
of observable inputs and minimize the use of unobservable inputs when measuring fair value. The
standard describes three levels of inputs that may be used to measure fair value:
Level 1 quoted prices in active markets for identical assets or liabilities
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Level 2 quoted prices for similar assets and liabilities in active markets or inputs that
are observable
Level 3 inputs that are unobservable (for example cash flow modeling inputs based on
assumptions)
Financial liabilities measured at fair value on a recurring basis are summarized below:
Fair value measurements at September 30, 2009 using | ||||||||||||||||
Significant | ||||||||||||||||
Quoted prices in | other | Significant | ||||||||||||||
active markets for | observable | unobservable | ||||||||||||||
September 30, | identical assets | inputs | inputs | |||||||||||||
2009 | (Level 1) | (Level 2) | (Level 3) | |||||||||||||
Liabilities: |
||||||||||||||||
Fair value of warrant obligations (Note 5) |
1,080,000 | | | 1,080,000 |
Subsequent Events
Management has evaluated subsequent events or transactions occurring through November 9, 2009,
the date the financial statements were issued.
Recent Accounting Pronouncements In December 2008, the FASB issued ASC 815-40 Contracts in
Entitys own Equity. This issue addresses the determination of whether an instrument (or an
embedded feature) is indexed to an entitys own stock, which is the first part of the scope
exception in paragraph 11(a) of Statement 133. This issue is effective for financial statements
issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal
years. The Company has included the impact of ASC 815-40 in its June 30, 2009 condensed
consolidated financial statements (Note 5).
In April 2009, the FASB issued ASC 820-10-65 Determining Fair Value When the Volume and Level
of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions
That Are Not Orderly. Based on the guidance, if an entity determines that the level of activity
for an asset or liability has significantly decreased and that a transaction is not orderly,
further analysis of transactions or quoted prices is needed, and a significant adjustment to the
transaction or quoted prices may be necessary to estimate fair value in accordance with Statement
of Financial Accounting Standards ASC 820-10 Fair Value Measurements. This is to be applied
prospectively and is effective for interim and annual periods ending after June 15, 2009 with early
adoption permitted for periods ending after March 15, 2009. The Company adopted this guidance for
its quarter ended June 30, 2009. The adoption has no impact on the Companys condensed consolidated
financial statements.
In April 2009, the FASB issued ASC 825, Financial Instruments (ASC 825). This standard
extends the disclosure requirements concerning the fair value of financial instruments to interim
financial statements of publicly traded companies. This guidance is effective for interim or annual
financial periods ending after June 15, 2009, and as such, became effective for the Company in the
quarter ended June 30, 2009. The adoption of ASC 855 had no material impact on the Companys
consolidated financial position, results of operations or cash flows.
In May 2009, the FASB issued guidance now codified as ASC Topic 855, Subsequent Events. ASC
Topic 855 establishes standards for the disclosure of events that occur after the balance sheet
date, but before financial statements are issued or are available to be issued. ASC Topic 855
introduces the concept of financial statements being available to be issued. It requires the
disclosure of the date through which an entity has evaluated subsequent events and the basis for
that date. The disclosure should alert all users of financial statements that an entity has not
evaluated subsequent events after that date in the set of financial statements being presented.
The Company adopted ASC Topic 855 for the period ended June 30, 2009. The adoption of ASC Topic
855 had no material impact on the Companys consolidated financial position, results of operations
or cash flows.
In July 2009, the FASB issued ASC 105, Generally Accepted Accounting Principles (ASC 105).
ASC 105 identifies the sources of accounting principles and the framework for selecting the
principles used in the preparation of financial statements of nongovernmental entities that are
presented in conformity with Generally Accepted Accounting Principles (GAAP) in the United States
(the GAAP hierarchy). ASC 105 is effective for financial statements issued for interim and annual
periods ending after September 15, 2009. Adoption of the standard did not have an impact on the
Companys condensed consolidated financial statements.
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In August 2009, the FASB issued ASU No. 2009-05, Fair Value Measurements and Disclosures
(Topic 820) Measuring Liabilities at Fair Value. This Accounting Standards Update amends
Subtopic 820-10, Fair Value Measurements and Disclosures > Overall, to provide guidance on the
fair value measurement of liabilities. The adoption of ASU 2009-05 is not expected to have a
material impact on our condensed consolidated financial statements.
Other
accounting standards that have been issued or proposed by the FASB
and SEC and/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.
Note 2. Liquidity and Financial Condition
The Company incurred a net loss of $1,893,000 and $5,434,000 for the three and six months
ended September 30, 2009, respectively. At September 30, 2009, the Companys accumulated deficit
amounted to $114,239,000. During the six months ended September 30, 2009, net cash used in
operating activities amounted to $3,355,000. At September 30, 2009, the Companys working capital
amounted to $6,373,000.
On June 1, 2009, the Company issued the final tranche from the February 24, 2009 private
placement (Note 6). The issuance comprised of an aggregate of 1,709,402 shares of common stock,
Series A Warrants to purchase an aggregate of 1,000,000 shares of common stock and Series B
Warrants to purchase an aggregate of 1,333,333 shares of common stock to the Investors pro rata to
the investment amount of each Investor. The Company received $2,000,000 in connection with this
transaction.
On July 30, 2009, the Company closed a registered direct placement of 2,454,000 shares of its
common stock at a purchase price of $2.45 per share, and warrants to purchase an aggregate of
1,226,991 shares of common stock at an exercise price of $3.3875 per share for gross proceeds of
$6,012,000 (net proceeds of $5,159,000 after deducting the placement agents commissions and other
offering costs).
During the three months ended September 30, 2009, the Company received $1,053,000 in
connection with the exercise of 780,000 common stock purchase warrants and the exercise of 521,110
stock options.
The Company currently anticipates that its cash and cash equivalents, the proceeds from the
July 30, 2009 registered direct offering, proceeds received from the exercise of common stock
purchase warrants and option exercises during the six months ended September 30, 2009, and revenues
it expects to generate will be sufficient to meet its anticipated cash requirements to continue its
sales and marketing and some research and development through at least September 30, 2010. However,
in order to execute the Companys Microcyn product development strategy and to penetrate new and
existing markets, the Company may need to raise additional funds, through public or private equity
offerings, debt financings, corporate collaborations or other means. The Company has implemented
cost cutting initiatives while continuing to increase revenue in an effort to reach cash breakeven.
The Company may raise additional capital to pursue its product development initiatives and
penetrate markets for the sale of its products.
Management believes that the Company has access to capital resources through possible public
or private equity offerings, debt financings, corporate collaborations or other means; however, the
Company has not secured any commitment for new financing at this time, nor can it provide any
assurance that new financing will be available on commercially acceptable terms, if needed. If the
Company is unable to secure additional capital, it may be required to curtail its research and
development initiatives and take additional measures to reduce costs in order to conserve its cash.
The Company has used, or intends to use, the proceeds from the offerings described above
principally for general corporate purposes, including working capital.
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Note 3. Condensed Consolidated Balance Sheet
Inventories
Inventories consisted of the following (in thousands):
September 30, | March 31, | |||||||
2009 | 2009 | |||||||
Raw materials |
$ | 320 | $ | 277 | ||||
Finished goods |
237 | 134 | ||||||
557 | 411 | |||||||
Less: inventory allowances |
(52 | ) | (71 | ) | ||||
$ | 505 | $ | 340 | |||||
Notes Payable
From February 7, 2005 to February 16, 2009, the Company entered into eight separate note
agreements for aggregate principal amounting to $596,000 with interest rates ranging from 3.99% to
14.44% per annum. These instruments are mostly connected to automobile and insurance premium
financing. During the three months ended September 30, 2009, the Company made principal and
interest payments related to these notes in the amounts of $133,000 and $3,000, respectively.
During the six months ended September 30, 2009, the Company made principal and interest payments
related to these notes in the amounts of $223,000 and $7,000, respectively. The remaining balance
of these notes amounted to $106,000 at September 30, 2009 of which $79,000 is included in the
current portion of long-term debt in the accompanying condensed consolidated balance sheet.
On August 29, 2009, the Company entered into a note agreement for principal amounting to
$100,000 with an interest rate of 2.90% per annum. This instrument is connected to financing an
automobile. During the three months ended September 30, 2009, the Company made principal and
interest payments related to this note in the amounts of $1,000 and $0, respectively. The
remaining balance of these notes amounted to $99,000 at September 30, 2009 of which $19,000 is
included in the current portion of long-term debt in the accompanying condensed consolidated
balance sheet.
Note 4. Commitments and Contingencies
Legal Matters
In February 2007, the Companys Mexico subsidiary served Quimica Pasteur (QP), 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.
The Company, from time to time, is involved in legal matters arising in the ordinary course of
its business including matters involving proprietary technology. While management believes that
such matters are currently not material, 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.
Employment Agreements
As of September 30, 2009, the Company had employment agreements with five of its key
executives. The agreements provide, among other things, for the payment of six to twenty-four
months of severance compensation for terminations under certain circumstances. With respect to
these agreements, at September 30, 2009, potential severance amounted to $1,305,000 and aggregated
annual salaries amounted to $1,840,000.
Board Compensation
On April 26, 2007, the Companys board of directors adopted a Non-Employee Director
Compensation Package (the Compensation Package) to provide members of the board and its
committees with regular compensation. The Compensation Package provides for cash compensation in
the amount of $25,000 to each non-employee member of the board of directors, and annual payments
ranging from $2,000 to $5,000 for participation on board committees. Employee directors do not
receive any form of compensation for their board
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participation. Additionally, on an annual basis the board members are automatically granted
15,000 stock options. The Company plans to issue stock options to the board members in lieu of cash
installments.
Commercial Agreements
On May 8, 2007, and June 11, 2007, the Company entered into separate commercial agreements
with two unrelated customers granting such customers the exclusive right to sell the Companys
products in specified territories or for specified uses. Both customers are required to maintain
certain minimum levels of purchases of the Companys products in order to maintain the exclusive
right to sell the Companys products. Up-front payments amounting to $625,000 paid under these
agreements have been recorded as deferred revenue. The short-term portion of the deferred revenue
related to these agreements amounted to $97,500 which is included in accrued expenses and other
current liabilities in the accompanying condensed consolidated balance sheet at September 30, 2009.
The up-front fees are being amortized on a straight-line basis over the terms of the underlying
agreements. For the three months ended September 30, 2009 and 2008, the Company amortized $24,000
and $24,000, respectively, and for the six months ended September 30, 2009 and 2008 the Company
amortized $48,000 and $48,000, respectively, related to these agreements. These amounts are
included in product revenue in the accompanying condensed consolidated statement of operations.
Amendment to Petaluma Building Lease
On May 1, 2009, the Company amended its lease for its facility in Petaluma which resulted in a
reduction of the Companys monthly lease payment. Pursuant to the amendment, the Company agreed to
surrender 8,534 square feet of office space and extended the lease expiration on the remaining
lease to September 30, 2011. The Company also agreed to provide the property owner a cash payment
of $50,000 no later than August 14, 2009. Additionally, on August 28, 2009 the property owner
received 53,847 shares of the Companys common stock (Note 6).
Agreements with Related Party
On January 26, 2009, the Company entered into a commercial agreement with Vetericyn, Inc., a
California corporation wholly-owned by the Companys director, Robert Burlingame, to market and
sell its Vetericyn products. Vetericyn, Inc. later changed its name to V&M Industries (V&M),
which remains wholly-owned by Mr. Burlingame. Additionally, Mr. Burlingame holds a significant
position in the Companys common stock. This agreement was amended on February 24, 2009 and on
July 24, 2009. Pursuant to the agreement, the Company provides V&M with bulk product and V&M
bottles, packages, and sells Vetericyn products. The Company receives a fixed amount for each
bottle of Vetericyn V&M sells. On September 15, 2009, V&M and the Company amended this agreement
whereby the Company granted V&M a non-exclusive right to market the Companys Microcyn
over-the-counter (OTC) liquid and gel products. . The Company manufactures the Microcyn OTC
products and will continue to bear all inventory and collection risks related to most of these
sales. Accordingly, the Company records most of this revenue on the gross basis and records
expenses related to V&Ms marketing efforts in selling, general and administrative expenses. In
addition, once certain milestones are met by V&M, the Company will share revenue generated by V&M
related to Vetericyn and Microcyn OTC sales. During the three and nine months ended September 30,
2009, the Company recorded $47,000 and $78,000, respectively, of revenue related to these
agreements. The revenue is recorded in product revenues in the accompanying condensed consolidated
statements of operations.
Other Matters
On September 16, 2005, the Company entered into a series of agreements with 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
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consolidated with the Companys consolidated financial statements for the period of
September 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 Companys 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.
Note 5. Derivative Liability
In accordance with the applicable provisions of Asc 815-40, Contracts in Entitys Own Equity,
financial instruments which do not have fixed settlement provisions are deemed to be derivative
instruments. The common stock warrants issued with the Companys August 13, 2007 private
placement, and the common stock warrants issued to the placement agent in the transaction, do not
have fixed settlement provisions because their exercise prices may be lowered if the Company issues
securities at lower prices in the future (Note 6). The Company was required to include the reset
provisions in order to protect the warrant holders from the potential dilution associated with
future financings. In accordance with ASC 815, the warrants were recognized as a derivative
instrument and have been re-characterized as derivative liabilities. ASC 815 requires that the fair
value of these liabilities be re-measured at the end of every reporting period with the change in
value reported in the statement of operations.
The derivative liabilities were valued using the Black-Scholes option valuation model and the
following assumptions on the following dates:
September 30, | April 1, | |||||||
2009 | 2009 | |||||||
Expected life |
2.87 years | 3.37 years | ||||||
Risk-free interest rate |
1.45 | % | 1.15 | % | ||||
Dividend yield |
0.00 | % | 0.00 | % | ||||
Volatility |
85 | % | 84 | % | ||||
Warrants issued with private placement |
1,105,502 | 953,752 | ||||||
Fair value of warrants |
$ | 1,080,000 | $ | 323,000 |
Effective April 1, 2009 the Company reclassified the fair value of these common stock purchase
warrants from equity to liability as if these warrants were treated as a derivative liability since
their date of issue. On April 1, 2009, the Company recorded a $323,000 derivative liability and a
corresponding charge to its accumulated deficit to recognize the cumulative effects of having
adopted this accounting policy. The fair value of these common stock purchase warrants increased
to $1,080,000 at September 30, 2009 from $323,000 at April 1, 2009. Accordingly, the Company
increased the derivative liability by $757,000 to reflect the change in fair value for the six
months ended September 30, 2009. This amount is included as a change in the fair value of
derivative instruments in the accompanying condensed consolidated statement of operations for the
six months ended September 30, 2009. Additionally, during the three months ended September 30,
2009, the Company recorded gains of $451,000 related to its derivative liabilities. This amount
represents a decrease in the fair value of its derivative liabilities from $1,531,000 at June 30,
2009 to $1,080,000 at September 30, 2009. This amount is included as income on derivative
instruments in the accompanying condensed consolidated statement of operations for the three months
ended September 30, 2009
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Note 6. Stockholders Equity
Common Stock Issued to Director
On April 1, 2009, the Company entered into a six month consulting agreement with a member of
its Board of Directors, Mr. Bob Burlingame. Pursuant to the agreement, Mr. Burlingame will provide
the Company with sales and marketing expertise and services. In consideration of his services,
the Company agreed to issue Mr. Burlingame 435,897 unregistered shares of its common stock. The
Company issued the shares on June 12, 2009. The shares were fully vested and non-forfeitable at
the time of issuance. The fair value of the common stock was more readily determinable than the
fair value of the services rendered. Following the guidance enumerated in ASC 505 Equity-Based
Payments to Non-Employees, the Company is amortizing the fair value of the warrants over the six
month term of the consulting agreement which is consistent with its treatment of similar cash
transactions. Accordingly, the Company will record $476,000 of stock compensation expense related
to this agreement which will be recognized on a straight-line basis over the six month term of the
agreement (April 1, 2009 to October 1, 2009). During the three and six months ended September 30,
2009, the Company recorded $238,000 and $476,000 of compensation expense, respectively. These
expenses were recorded as selling, general and administrative expense in the accompanying condensed
consolidated statements of operations.
Common Stock Issued to Service Provider
On April 24, 2009, the Company entered into an agreement with a contract sales organization
(CSO) that will serve as the Companys sales force for the sale of wound care products in the
United States. Pursuant to the agreement, the Company agreed to pay the CSO a monthly fee and
potential bonuses that will be based on achievement of certain levels of sales. The Company agreed
to issue the CSO shares of common stock each month as compensation for its services. During the
three and six months ended September 30, 2009, the Company issued 5,600 and 24,500 shares of common
stock, respectively, in connection with this agreement. The Company has determined the fair value
of the common stock, which was calculated as shares were issued, is more readily determinable than
the fair value of the services rendered. Accordingly, the Company recorded the fair market value
of the stock as compensation expense. The expense will be recognized as the shares of stock are
earned. During the three and six months ended September 30, 2009, the Company recorded $14,000 and
$40,000 of compensation expense, respectively. These expenses were recorded as selling, general
and administrative expense in the accompanying condensed consolidated statements of operations.
Common Stock Issued in Private Placement
On February 24, 2009, the Company entered into a Purchase Agreement with Robert Burlingame, a
director of the Company, and an accredited investor. Pursuant to the terms of the Purchase
Agreement, the investors agreed to make a $3,000,000 investment in the Company. The investors paid
$1,000,000 (net proceeds of $948,000 after deducting offering expenses) for 854,701 shares of
common stock on February 24, 2009 and paid $2,000,000 for 1,709,402 shares of common stock on June
1, 2009. In addition, the Company issued to the investors Series A Warrants to purchase a total
of 1,500,000 shares of common stock pro rata to the number of shares of common stock issued on each
closing date at an exercise price $1.87 per share. The Series A Warrants are exercisable after six
months and will have a five year term. The Company also issued to the investors Series B Warrants
to purchase a total of 2,000,000 shares of common stock pro rata to the number of shares of common
stock issued on each closing date at an exercise price of $1.13 per share. The Series B Warrants
are exercisable after six months and will have a three year term. In addition, for every two shares
of common stock the investor purchases upon exercise of a Series B Warrant, the investor will
receive an additional Series C Warrant to purchase one share of common stock. The Series C Warrant
shall be exercisable after six months and will have an exercise price of $1.94 per share and a five
year term. The Company will only be obligated to issue Series C Warrants to purchase up to
1,000,000 shares of common stock.
Registered Direct Offering
On July 30, 2009, the Company closed a registered direct placement of Units of its common
stock to certain accredited investors. For each Unit purchased in this offering, the investors
received one share of the Companys common stock and a warrant to purchase one half of one share of
common stock. The offering price of each Unit was $2.45 per Unit. The Company sold 2,454,000
Units consisting of 2,454,000 shares of common stock and 1,226,991 warrants to purchase common
stock. The exercise price of each warrant is $3.3875 per share, the warrants become exercisable
six months following the close of the offering and expire five years following the close of the
offering. The Company received gross proceeds of $6,012,000 (net proceeds of $5,159,000 after
deducting the placement agents commissions and other offering costs) from this offering.
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Common Stock Issued to Settle Obligations
During the three months ended September 30, 2009, the Company issued shares of common stock to
various vendors to settle outstanding accounts payables. The Company entered into settlement
agreements with these vendors and issued a total of 155,755 shares with a fair value equal to the
outstanding payables or $377,000. Additionally, the Company issued the property owner of its
Petaluma, CA facility 53,847 shares with a fair value of $70,000. These shares were issued as
partial settlement in connection with the renegotiation of the lease and will be amortized on a
straight-line basis over the remaining term of the lease which expires on September 30, 2011.
Anti-dilution Adjustments
Pursuant to an anti-dilution provision contained in both the August 13, 2007 private placement
investor and placement agent warrant agreements, for various transactions during the six months
ended September 30, 2009, the Company was required to adjust the exercise price and the number of
warrants held by each warrant holder under these agreements. These adjustments were the result of
the issuance of the 2,454,000 Units issued in connection with the registered direct offering closed
on July 30, 2009, the issuance of 465,997 shares of common stock to certain consultants in
consideration for their services, and 209,602 shares of common stock issued in connection with the
settlement of certain obligations. The exercise price for the warrants was adjusted from $5.03 to
$4.34 and an additional 151,750 warrants were issued. At September 30, 2009, the total number of
warrants outstanding subject to adjustment was 1,105,502.
Note 7. Stock-Based Compensation
The Company accounts for share-based awards exchanged for employee services in accordance with
ASC 718 Compensation-Stock Compensation (ASC 718) under which share-based compensation expense
is measured at the grant date, based on the estimated fair value of the award. The Company
estimates the fair value of employee stock awards using the Black-Scholes option pricing model. The
Company amortizes the fair value of employee stock options on a straight-line basis over the
requisite service period of the awards.
The effect of recording stock-based compensation expense in accordance with the applicable
provisions of ASC 718 is as follows (in thousands, except per share amounts):
Three Months | Six Months | |||||||||||||||
Ended | Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Cost of service revenue |
$ | 5 | $ | 3 | $ | 10 | $ | 7 | ||||||||
Research and development |
17 | 19 | 46 | 70 | ||||||||||||
Selling, general and administrative |
167 | 1,358 | 334 | 1,679 | ||||||||||||
Total stock-based compensation |
$ | 189 | $ | 1,380 | $ | 390 | $ | 1,756 | ||||||||
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 fair value of employee stock options was estimated using the following weighted-average
assumptions:
Three Months | Six Months | |||||||||||||||
Ended | Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Expected life |
6.0 years | 5.5 years | 6.0 years | 6.1 years | ||||||||||||
Risk-free interest rate |
1.65 | % | 3.00 | % | 1.65 | % | 3.18 | % | ||||||||
Dividend yield |
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % | ||||||||
Volatility |
85 | % | 73 | % | 85 | % | 75 | % |
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The expected term 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 110 for plain vanilla options. The Company used this approach
as it did not have sufficient historical exercise 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 was determined by examining the
historical volatilities for industry peers and using an average of the historical volatilities of
the Companys industry peers. The Company will continue to analyze the stock price volatility and
expected term assumptions as more data for the Companys common stock and exercise patterns 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 payouts.
In addition, ASC 718 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 at 5% based on historical experience.
A summary of all option activity as of September 30, 2009 and changes during the nine months
then ended is presented below:
Weighted- | Weighted- | Aggregate | ||||||||||||||
Average | Average | Intrinsic | ||||||||||||||
Shares | Exercise | Contractual | Value | |||||||||||||
Options | (000) | Price | Term | ($000) | ||||||||||||
Outstanding at April 1, 2009 |
3,964 | $ | 3.28 | |||||||||||||
Granted |
150 | 2.18 | ||||||||||||||
Exercised |
(521 | ) | 0.33 | |||||||||||||
Forfeited or expired |
(374 | ) | 8.25 | |||||||||||||
Outstanding at September 30, 2009 |
3,219 | $ | 3.14 | 7.77 | $ | 3,028 | ||||||||||
Exercisable at September 30, 2009 |
1,523 | $ | 4.58 | 6.24 | $ | 778 | ||||||||||
In addition to the above option activity, on April 26, 2007, an award of 60,000 stock units
was issued to an officer of the Company. 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, were forfeited on January 15, 2009 and the
remaining 30,000 will be settled on January 15, 2010.
The aggregate intrinsic value is calculated as the difference between the exercise price of
the stock options and the underlying fair value of the Companys common stock (2.43) for stock
options that were in-the-money as of September 30, 2009.
At September 30, 2009, there was unrecognized compensation costs of $1,630,000 related to
stock options accounted for in accordance with the provisions of SFAS 123(R). The cost is expected
to be recognized over a weighted-average amortization period of 2.39 years.
The Company issues new shares of common stock upon exercise of stock options.
As provided under the Companys 2006 Stock Incentive Plan (2006 Plan), the aggregate number
of shares authorized for issuance as awards under the 2006 Plan automatically increased on April 1,
2009 by 920,141 shares (which number constitutes 5% of the outstanding shares on the last day of
the year ended March 31, 2009). Additionally, by a vote of the shareholders of the Company the
shares authorized for issuance under the plan was increased by 1,000,000. Remaining shares
authorized for issuance from the 2006 Plan at September 30, 2009 was 2,039,000.
Note 8. Income Taxes
The Company has completed a study to assess whether a change in control has occurred or
whether there have been multiple changes of control since the Companys formation. The study
concluded that no change in control occurred for purposes of Internal Revenue Code section 382. 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 ended September 30, 2009. 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 ASC 740 Income Taxes (ASC 740), the valuation allowance will be reduced
accordingly.
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ASC 740 addresses how tax benefits claimed or expected to be claimed on a tax return should be
recorded in the financial statements. Under ASC 740, the tax benefit from an uncertain tax position
can be recognized only if it is more likely than not that the tax position will be sustained on
examination by the taxing authorities, based on the technical merits of the position. The tax
benefits recognized in the financial statements from such a position are measured based on the
largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate
resolution. ASC 740 had no impact on the Companys financial condition, results of operations or
cash flows.
The Company has identified its federal tax return and its state tax return in California as
major tax jurisdictions. The Company is also subject to certain other foreign jurisdictions,
principally Mexico and The Netherlands. The Companys evaluation of ASC 740 tax matters was
performed for tax years ended through March 31, 2009. Generally, the Company is subject to audit
for the years ended March 31, 2008, 2007 and 2006 and maybe be subject to audit for amounts
relating to net operating loss carryforwards generated in periods prior to March 31, 2005. The
Company has elected to retain its existing accounting policy with respect to the treatment of
interest and penalties attributable to income taxes in accordance with ASC 740, and continues to
reflect interest and penalties attributable to income taxes, to the extent they arise, as a
component of its income tax provision or benefit as well as its outstanding income tax assets and
liabilities. The Company believes that its income tax positions and deductions would be sustained
on audit and does not anticipate any adjustments, other than those identified above that would
result in a material change to its financial position.
Note 9. Segment and Geographic Information
The Company is organized primarily on the basis of operating units which are segregated by
geography, United States (U.S.), Europe and Rest of the World (Europe/ROW) and Mexico.
The following tables present information about reportable segments (in thousands):
Europe/ | ||||||||||||||||
Three months ended September 30, 2009 | U.S. | ROW | Mexico | Total | ||||||||||||
Product revenues |
$ | 160 | $ | 353 | $ | 890 | $ | 1,403 | ||||||||
Service revenues |
269 | | | 269 | ||||||||||||
Total revenues |
429 | 353 | 890 | 1,672 | ||||||||||||
Depreciation and amortization expense |
83 | 9 | 23 | 115 | ||||||||||||
Profit (loss) from operations |
(2,411 | ) | 78 | 78 | (2,255 | ) | ||||||||||
Interest expense |
(3 | ) | | | (3 | ) | ||||||||||
Interest income |
| | | |
Europe/ | ||||||||||||||||
Three months ended September 30, 2008 | U.S. | ROW | Mexico | Total | ||||||||||||
Product revenues |
$ | 68 | $ | 233 | $ | 911 | $ | 1,212 | ||||||||
Service revenues |
269 | | | 269 | ||||||||||||
Total revenues |
337 | 233 | 911 | 1,481 | ||||||||||||
Depreciation and amortization expense |
103 | 60 | 32 | 195 | ||||||||||||
Loss from operations |
(6,674 | ) | (170 | ) | (1 | ) | (6,845 | ) | ||||||||
Interest expense |
(149 | ) | | | (149 | ) | ||||||||||
Interest income |
56 | | | 56 |
Europe/ | ||||||||||||||||
Six months ended September 30, 2009 | U.S. | ROW | Mexico | Total | ||||||||||||
Product revenues |
$ | 289 | $ | 583 | $ | 2,098 | $ | 2,970 | ||||||||
Service revenues |
549 | | | 549 | ||||||||||||
Total revenues |
838 | 583 | 2,098 | 3,519 | ||||||||||||
Depreciation and amortization expense |
158 | 35 | 44 | 237 | ||||||||||||
Profit (loss) from operations |
(4,948 | ) | (22 | ) | 414 | (4,556 | ) | |||||||||
Interest expense |
(7 | ) | | | (7 | ) | ||||||||||
Interest income |
1 | | | 1 |
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Six months ended September 30, 2008 | U.S. | Europe/ ROW | Mexico | Total | ||||||||||||
Product revenues |
$ | 132 | $ | 418 | $ | 1,669 | $ | 2,219 | ||||||||
Service revenues |
473 | | | 473 | ||||||||||||
Total revenues |
605 | 418 | 1,669 | 2,692 | ||||||||||||
Depreciation and amortization expense |
207 | 122 | 115 | 444 | ||||||||||||
Loss from operations |
(11,516 | ) | (333 | ) | (70 | ) | (11,919 | ) | ||||||||
Interest expense |
(311 | ) | | | (311 | ) | ||||||||||
Interest income |
132 | | | 132 |
Sales by geography reported in the Europe/ROW segment is as follows (in thousands):
Three Months | Six Months | |||||||||||||||
Ended | Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
India |
$ | 50 | $ | 32 | $ | 79 | $ | 59 | ||||||||
China |
103 | 79 | 209 | 79 | ||||||||||||
Europe and other |
200 | 122 | 295 | 280 | ||||||||||||
Total Europe/ROW |
$ | 353 | $ | 233 | $ | 583 | $ | 418 | ||||||||
The following table shows property and equipment balances by segment (in thousands):
September 30, | March 31, | |||||||
2009 | 2009 | |||||||
U.S. |
$ | 1,031 | $ | 931 | ||||
Europe/ROW |
42 | 322 | ||||||
Mexico |
200 | 179 | ||||||
$ | 1,273 | $ | 1,432 | |||||
The following table shows total asset balances by segment (in thousands):
September 30, | March 31, | |||||||
2009 | 2009 | |||||||
U.S. |
$ | 7,999 | $ | 3,543 | ||||
Europe/ROW |
542 | 841 | ||||||
Mexico |
1,429 | 1,063 | ||||||
$ | 9,970 | $ | 5,447 | |||||
Note 10.
Subsequent Events
Stock
Option Grants to Directors
On November 6, 2009, the Company granted its director Greg French a
option to purchase 75,000 shares of the Companys common stock
at an exercise price of $1.89 per share. The options will vest over a
three year period and will expire on November 6, 2019. Additionally,
on November 6, 2009, the Company granted its director Jay Birnbaum a
option to purchase 50,000 shares of the Companys common stock
at an exercise price of $1.89 per share. The options will vest over a
six month period and will expire on November 6, 2019.
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 September 30, 2009 and our audited
consolidated financial statements for the year ended March 31, 2009 included in our report on Form
10-K, that was filed with the Securities and Exchange Commission on June 11, 2009.
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,
suggests, believes, intends, estimates, plans, projects, continue, ongoing,
potential, expect, predict, believe, intend, may, will, should, could, would
and similar expressions are intended to identify forward-looking statements.
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Forward-looking statements are subject to risks and uncertainties that could cause our actual
results to differ materially from those projected. These risks and uncertainties include, but are
not limited to the risks described in our Annual Report on Form 10-K including our ability to
develop and commercialize new products; the risks in obtaining patient enrollment for our studies;
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 FDA; our ability to compete
against third parties; our ability to obtain capital when needed; our history of operating losses;
the risks associated with protecting our intellectual property; and the additional risks set forth
under Part II, Item 1A, Risk Factors, included in this Quarterly Report on Form 10-Q as well s
other risks disclosed in our SEC filings from time to time. These forward-looking statements speak
only as of the date hereof. We expressly disclaim any obligation or undertaking to release publicly
any updates or revisions to any forward-looking statements contained herein to reflect any change
in our expectations with regard thereto or any change in events, conditions or circumstances on
which any such statement is based, except as required by law.
Our Business
We develop, manufacture and market, a family of products intended to prevent and treat
infections in chronic and acute wounds while concurrently enhancing wound healing through modes of
action unrelated to the treatment of infection. 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 a proprietary solution of electrically charged
oxychlorine small molecules designed to treat a wide range of organisms that cause disease
(pathogens). These include 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.
We do not have the necessary regulatory approvals to market Microcyn in the United States as a
drug. In the United States our device product does, however, have five clearances as a 510(k)
medical device for the following summary indications: 1) Moistening and lubricating absorbent wound
dressings for traumatic wounds requiring a prescription: 2) Moistening and debriding acute and
chronic dermal lesions requiring a prescription: 3) Moistening absorbent wound dressings and
cleaning minor cuts as an over the counter product: 4) Management of exuding wounds such as leg
ulcers, pressure ulcers, diabetic ulcers and for the management of mechanically or surgically
debridement of wounds in a gel form and required as a prescription: 5) Debridement of wounds, such
as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second burns,
grafted and donor sites as a preservative, which can kill listed bacteria such as MRSA & VRE and
required as a prescription. We do not have the necessary regulatory clearance or approval to market
Microcyn in the U.S. as a medical device for an antimicrobial or wound healing indication. In the
future we expect to apply with the FDA for clearance as an antimicrobial in a liquid and a gel form
and as conducive to wound healing via a 510(k) medical clearance.
Outside the United States our product has a CE Mark device approval in Europe for debriding,
irrigating and moistening acute and chronic wounds in comprehensive wound treatment by reducing
microbial load and creating moist environment. In Mexico we are approved as a drug as antiseptic
treatment of wounds and infected areas. In India our product has a drug license for cleaning and
debriding in wound management while in China there is a medical device approval by the State Food
and Drug Administration or SFDA, for reducing the propagation of microbes in wounds and creating a
moist environment for wound healing.
While in the U.S. we do not have the necessary regulatory clearance for an antimicrobial or
wound healing indication, clinical and laboratory testing we conducted in connection with our
submissions to the FDA, as well as physician clinical studies and scientific papers, suggest that
our Microcyn-based product may help reduce a wide range of pathogens from acute and chronic wounds
while curing or improving infection and concurrently enhancing wound healing through modes of
action unrelated to the treatment of infection. These physician clinical studies suggest that our
Microcyn-based product is safe, easy to use and complementary to many existing treatment methods in
wound care. Physician clinical studies and usage in the United States suggest that our 510(k)
product may shorten hospital stays, lower aggregate patient care costs and, in certain cases,
reduce the need for systemic antibiotics. We are also pursuing the use of our Microcyn platform
technology in other markets outside of wound care, including in the respiratory, ophthalmology,
dental and dermatology markets.
In 2005, chronic and acute wound care represented an aggregate of $9.6 billion in global
product sales, of which $3.3 billion was spent for the treatment of skin ulcers, $1.6 billion to
treat burns and $4.7 billion for the treatment of surgical and trauma wounds, according to Kalorama
Information, a life sciences market research firm. In the Kalorama Information we believe the
markets most related to our product involve approximately $1.3 billion for the treatment of skin
ulcers, $300 million for the treatment of burns and
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$700 million for the treatment of surgical and
trauma wounds. Common methods of controlling infection, including topical antiseptics
and antibiotics, have proven to be only moderately effective in combating infection in the
wound bed. However, topical antiseptics tend to inhibit the healing process due to their toxicity
and may require specialized preparation or handling. Antibiotics can lead to the emergence of
resistant bacteria, such as MRSA and VRE. Systemic antibiotics may be less effective in controlling
infection in patients with disorders affecting circulation, such as diabetes, which are commonly
associated with chronic wounds. As a result, no single treatment is used across all types of wounds
and stages of healing.
We believe Microcyn is the only known stable, anti-infective therapeutic available in the
world today that simultaneously cures or improves infection while also promoting wound healing
through increased blood flow to the wound bed and reduction of inflammation. Also, we believe
Microcyn provides significant advantages over current methods of care in the treatment of a wide
range of chronic and acute wounds throughout all stages of treatment. These stages include
cleaning, debridement, prevention and treatment of infections and wound healing. We believe that
unlike antibiotics, antiseptics, growth regulators and other advanced wound care products, Microcyn
is the only stable wound care solution that is safe as saline, and also cures infection while
simultaneously accelerating wound healing. Also, unlike most antibiotics, 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.
Our goal is to become a worldwide leader as the standard of care in the treatment and
irrigation of open wounds. We currently have, and intend to seek additional, regulatory clearances
and approvals to market our Microcyn-based products worldwide. In July 2004, we began selling
Microcyn in Mexico after receiving approval from the Mexican Ministry of Health, or MOH, for the
use of Microcyn as an antiseptic, disinfectant and sterilant. Since then, physicians in the United
States, Europe, India, Pakistan, China and Mexico have conducted more than 28 physician clinical
studies assessing Microcyns use in the treatment of infections in a variety of wound types,
including hard-to-treat wounds such as diabetic ulcers and burns. Most of these studies 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, or NDA,
submission to the FDA. A number of these studies did not include blinding, randomization,
predefined clinical end points, use of placebo and active control groups or U.S. good clinical
practices requirements. We used the data generated from some of these studies to support our
application for the CE Mark, or European Union certification, for wound cleaning and reduction of
microbial load. We received the CE Mark in November 2004 and additional international approvals in
China, Canada, Mexico and India. Microcyn has also received five FDA 510(k) clearances for use as a
medical device in wound cleaning, or debridement, lubricating, moistening and dressing, including
traumatic wounds and acute and chronic dermal lesions. Most recently, on May 27, 2009, we received
a 510(k) clearance from the FDA to market our Microcyn Skin and Wound Gel as both a prescription
and over-the-counter formulation Additionally, on June 4, 2009, we received an expanded 510(k)
label clearance from the FDA to market our Microcyn Skin and Wound Cleanser with preservatives as
both a prescription and over-the-counter formulation. This prescription product is indicated for
use by health care professionals to manage the debridement of wounds such as stage I-IV pressure
ulcers, diabetic foot ulcers, post-surgical wounds, first- and second-degree wounds, grafted and
donor sites.
In the fourth quarter of 2007, we completed a Phase II randomized clinical trial, which was
designed to evaluate the effectiveness of Microcyn in mildly infected diabetic foot ulcers with the
primary endpoint of clinical cure or improvement in signs and symptoms of infection according to
guidelines of Infectious Disease Society of America. We used 15 clinical sites and enrolled 48
evaluable patients in three arms, using Microcyn alone, Microcyn plus an oral antibiotic and saline
plus an oral antibiotic. We announced the results of our Phase II trial in March 2008. In the
clinically evaluable population of the study, the clinical success rate at visit four (test of
cure) for patients treated with Microcyn alone was 93.3% compared to 56.3% for the Levofloxacin
plus saline-treated patients. This study was not statistically powered, but the high clinical
success rate (93.3%) and the p-value (0.033) would suggest the difference is meaningfully positive
for the Microcyn-treated patients. Also, for this set of data, the 95.0% confidence interval for
the Microcyn-only arm ranged from 80.7% to 100.0% while the 95.0% confidence interval for the
Levofloxacin and saline arm ranged from 31.9% to 80.6%; the confidence intervals do not overlap,
thus indicating a favorable clinical success for Microcyn compared to Levofloxacin. At visit three
(end of treatment) the clinical success rate for patients treated with Microcyn alone was 77.8%
compared to 61.1% for the Levofloxacin plus saline-treated patients.
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We conducted a review meeting with the FDA in August 2008 to discuss the results of our Phase
II trial and our future clinical
program. Following a review of the Phase II data on Microcyn Technology for the treatment of
mildly infected diabetic foot ulcers, the FDA agreed:
| We may move forward into the pivotal phase of our U.S. clinical program for Microcyn Technology. | ||
| There were no safety issues relative to moving into this next clinical phase immediately, and carcinogenicity studies will not be required for product approval; and | ||
| Clinical requirements for efficacy and safety for a new drug application, or NDA, will be appropriately accounted for within the agreed upon pivotal trial designs. |
Two pivotal clinical trials must be completed for submission to the FDA of an NDA, for the
treatment of mildly infected diabetic foot ulcers. Commencement of these trials will be dependent
upon the support of a strategic partner. In the event that we successfully complete clinical trials
and obtain drug approval from the FDA, we may seek clearance for treatment of other types of
wounds. We are currently pursuing strategic partnerships to assess potential applications for
Microcyn in several other markets and therapeutic categories, including respiratory, ophthalmology,
dermatology, dental and veterinary markets. FDA or other governmental approvals will be required
for any potential new products or new indications.
We currently make Microcyn available, both as a prescription and over-the-counter product,
under our five 510(k) clearances in the United States, primarily through Advocos, a specialty U.S.
contract sales organization. In the quarter ending December 31, 2008, we initiated
commercialization into the podiatry market in the United States. In the second calendar quarter of
2009, we expanded this sales effort to include wound care centers, hospitals, nursing homes, urgent
care clinics and home healthcare.
On January 26, 2009, we announced a strategic revenue-sharing partnership with V&M Industries,
Inc., whose principal is one of our directors. Pursuant to this agreement we granted V&M
Industries, Inc. exclusive rights to market the Microcyn Technology in the North American animal
healthcare market. As part of this agreement, we will not incur marketing or sales expenses, but
will share in all revenues. On September 15, 2009, the agreement with V&M Industries, Inc. was
modified to include a non exclusive right to sell the Microcyn OTC into the human healthcare market
on terms similar to those in the original agreement.
Our partner, Union Springs Pharmaceuticals, a subsidiary of the Drug Enhancement Company of
America, or DECA, has marketed MyClyns, an over-the-counter first responder pen application, with
Microcyn in the United States since January 2008.
We have announced the development of a Microcyn hydrogel which received a 510(k) approval in
the U.S. We will pursue additional approvals in Europe, China, India and Mexico and we will
initiate commercialization upon obtaining these approvals.
We currently rely on exclusive agreements with country-specific distributors for the sale of
Microcyn-based products in Europe. In Mexico, we sell Microcyn through a network of distributors
and through a contract sales force dedicated exclusively to selling Microcyn, including
salespeople, nurses and clinical support staff. In India, we sell through Alkem, the fifth largest
pharmaceutical company in India. The first full year of Microcyn product distribution in India was
in 2008. In China, we signed a distribution agreement with China Bao Tai, which secured marketing
approval from the SFDA in March 2008. China Bao Tai is working with Sinopharm, the largest
pharmaceutical group in China, to distribute Microcyn-based products to hospitals, doctors and
clinics. China Bao Tai and Sinopharm are in process of providing product broadly to many hospitals
and doctors throughout many provinces in China for completion of trials in anticipation of a
product launch after pricing registration and reimbursement approval have been obtained.
We also operate a microbiology contract testing laboratory division that provides consulting
and laboratory services to medical companies that design and manufacture biomedical devices and
drugs, as well as testing on our products and potential products. Our testing laboratory complies
with U.S. good manufacturing practices and quality systems regulation.
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Comparison of Three Months Ended September 30, 2009 and 2008
Revenues
Total revenues were $1,672,000 during the quarter ended September 30, 2009 compared to
$1,481,000 in the prior year period. Product revenues increased $191,000 due to higher sales in
Europe, US, China, India and Singapore. In local currency, product revenue growth in Mexico was 26%
while it was down slightly when translated to dollars due to a 29% decrease in the value of the
peso. Without the drop in the value of the peso during the quarter, product growth in Mexico would
have been 26% and product growth worldwide would have been 37%. Unit sales of our 240-milliliter
presentation, sold mostly to pharmacies in Mexico increased 6% over the prior year to a monthly
average of 33,000 units compared to 31,000 units in the same quarter last year; unit sales to
hospitals increased 38%, partially offset by lower selling prices. Europe/ROW sales increased
$120,000 up 52%, over the prior year due to higher sales in Europe, China, India and Singapore.
Sales in the US increased $92,000 with strong increases in human and animal wound care, related
mostly to TV advertising and programs, sponsored by V&M, Industries, Inc..
The following table shows our product revenues by geographic region:
Three Months | ||||||||||||||||
Ended September 30, | ||||||||||||||||
2009 | 2008 | Increase | Increase | |||||||||||||
U.S. |
$ | 160,000 | $ | 68,000 | $ | 92,000 | 135 | % | ||||||||
Europe/ROW |
353,000 | 233,000 | 120,000 | 52 | % | |||||||||||
Mexico |
890,000 | 911,000 | (21,000 | ) | (2 | %) | ||||||||||
Total |
$ | 1,403,000 | $ | 1,212,000 | $ | 191,000 | 16 | % | ||||||||
Service revenue was about flat compared to same quarter last year with the focus on the
product revenue.
Gross Profit
We reported gross profit from our Microcyn products business of $802,000, or 57% of product
revenues, during the three months ended September 30, 2009, compared a gross profit of $766,000, or
63%, in the prior year period. This decrease was primarily due to higher costs in Europe and U.S.
as we were transferring our manufacturing from Europe to the US during the current quarter while
sustaining costs in both locations. We also incurred shipping costs of equipment and non cash
losses due to the write off of equipment and some inventory. Mexicos margins were about the same
at 79% during the quarter ended September 30, 2009, compared to 78% in the prior year period.
Research and Development Expense
Research and development expense declined $1,784,000, or 75%, to $583,000 for the three months
ended September 30, 2009, compared to $2,367,000 in the prior year period. Most of the decrease was
attributable to the elimination of the larger clinical team in the quarter ended September 30,
2008, which had supported the completion of the Phase II clinical trial last year and related
expenses. As a result of shifting our strategy to find a strategic partner to conduct the Phase III
trials, we significantly reduced the number of people in research and development and clinical
activities.
We expect that our research and development expense will remain fairly flat over the next few
quarters.
Selling, General and Administrative Expense
Selling, general and administrative expense decreased $2,777,000, or 53%, to $2,485,000 during
the three months ended September 30, 2009, from $5,262,000 during the three months ended September
30, 2008. Primarily, this decrease was due to stock compensation expense of $1,454,000 recorded
during the three months ended September 30, 2008, an overall reduction in headcount and related
expenses, and lower legal and accounting fees. These decreases were partially offset by higher
sales and marketing expenses associated with our wound care product launch in U.S. and Mexico.
We expect selling, general and administrative expenses to grow slightly in future periods as
we spend more money on expanding sales in the U.S. market.
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Interest income and expense and other income and expense, net
Interest expense decreased $146,000 to $3,000 for the three months ended September 30, 2009,
from $149,000 in the prior year period, due to the payments made on debt over the prior year. Total
outstanding debt decreased to $207,000 at September 30, 2009, from $335,000 at March 31, 2009.
Interest income decreased $55,000 from the prior year period, primarily due to the decrease in our
interest bearing average cash balance.
Other income and expense, net increased $112,000 to net other expense of $86,000 for the three
months ended September 30, 2009, from net other income of $26,000 for the same period last year.
Gain on derivative liability
During the three months ended September 30, 2009 we incurred a reduction in our derivative
liabilities of $451,000 and as a result we recorded this amount as income in our statement of
operations for this period. For the three months ended September 30, 2008 we did not record a loss
or gain as it was not required.
Net Loss
Net loss for the three months ended September 30, 2009 was $1,893,000, down $5,019,000 from
$6,912,000 for the same period in the prior year. Stock compensation expense for the quarter ended
September 30, 2009 and 2008 was $441,000 and $1,454,000, respectively.
Comparison of Six Months Ended September 30, 2009 and 2008
Revenues
Total revenues were $3,519,000 during the six months ended September 30, 2009, up 31%,
compared to $2,692,000 in the prior year period. The $751,000 increase in product revenues was due
primarily to higher sales in the U.S., Europe and Mexico, up 34% compared to the same period last
year. Without the 28% drop in the value of the peso during the six months ended September 30, 2009,
product growth in Mexico would have been 61% and product growth worldwide would have been 61%. As
a result of the swine flu epidemic in Mexico and normal growth, unit sales for six months ended
September 30, 2009, of our 240-milliliter presentation, sold mostly to pharmacies in Mexico,
increased 57% over the prior year to a monthly average of 47,000 units, up from 30,000 in the same
period last year; unit sales to hospitals increased 68%, partially offset by lower selling prices.
Europe/ROW sales increased $165,000, up 39%, over the prior year with higher sales from China,
India and Singapore. Sales in the U.S. increased $157,000 with strong increases in human and
animal wound care, related mostly to television advertising and other programs sponsored by V&M
Industries, Inc.
The following table shows our product revenues by geographic region (in thousands):
Six Months | ||||||||||||||||
Ended September 30, | ||||||||||||||||
2009 | 2008 | Increase | Increase | |||||||||||||
U.S. |
$ | 289,000 | $ | 132,000 | $ | 157,000 | 119 | % | ||||||||
Europe/ROW |
583,000 | 418,000 | 165,000 | 39 | % | |||||||||||
Mexico |
2,098,000 | 1,669,000 | 429,000 | 26 | % | |||||||||||
Total |
$ | 2,970,000 | $ | 2,219,000 | $ | 751,000 | 34 | % | ||||||||
The $76,000 increase in service revenues was due to an increase in the number of tests
provided by our services business.
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Gross Profit
We reported gross profit from our Microcyn products business of $1,842,000, or 62% of product
revenues, during the six months ended September 30, 2009, compared to a gross profit of $1,335,000,
or 60%, in the prior year period. Mexicos margins improved to
81% during the six months ended September 30, 2009, compared to 73% in the prior year period
with higher unit volume in the first quarter due the swine flu epidemic. During the six months
ended September 30, 2009, gross margins in Europe and U.S. are relatively low as we are
transferring our manufacturing from Europe to the U.S., sustaining costs in both locations and
including severance costs in European cost of goods sold.
Research and Development Expense
Research and development expense declined $3,384,000, or 72%, to $1,304,000 for the six months
ended September 30, 2009, compared to $4,688,000 in the prior year period. Most of the decrease was
attributable to the elimination of the larger clinical team and related expenses durig the six
months ended September 30, 2009, which supported the completion of the Phase II clinical trial. As
a result of shifting our strategy to find a strategic partner to conduct the Phase III trials, we
significantly reduced the number of people in research and development and clinical activities.
We expect that our research and development expense will remain fairly flat over the next few
quarters.
Selling, General and Administrative Expense
Selling, general and administrative expense decreased $3,420,000, or 40%, to $5,170,000 during
the six months ended September 30, 2009, from $8,590,000 during the six months ended September 30,
2008. Primarily, this decrease was due to a $1,188,000 reduction in stock compensation charges,
lower legal and accounting fees and an overall reduction in headcount and related expenses. These
decreases were partially offset by higher sales and marketing expenses associated with our wound
care product launch in the U.S. and Mexico.
We expect selling, general and administrative expenses to grow slightly in future periods as
we spend more money on expanding sales in the U.S. market.
Interest income and expense and other income and expense, net
Interest expense decreased $304,000 to $7,000 for the six months ended September 30, 2009,
from $311,000 in the prior year period, due to the payments made on debt over the prior year.
Interest income decreased $131,000, to $1,000 for the six months ended September 30, 2009, from
$132,000 in the prior year period, primarily due to the decrease in our interest bearing cash
balance.
Other income and expense, net increased $102,000 to net other expense of $115,000 for the six
months ended September 30, 2009, from net other expense of $13,000 for the same period last year.
Loss on derivative liability
During the six months ended September 30, 2009 we incurred an increase in derivative
liabilities of $757,000 and as a result recorded a loss in our statement of operations for this
period. For the six months ended September 30, 2008 we did not record a loss or gain as it was not
required.
Net Loss
Net loss for the six months ended September 30, 2009 was $5,434,000, down $6,677,000 from
$12,111,000 for the same period in the prior year. Stock compensation expense for the six months
ended September 30, 2009 and 2008 was $906,000 and $1,911,000, respectively. Also, the loss
related to our derivative liabilities of $757,000 was a non-cash charge.
Liquidity and Capital Resources
At September 30, 2009, our accumulated deficit amounted to $114,239,000. We had working
capital of $6,373,000 as of September 30, 2009. We currently anticipate that our cash and cash
equivalents, the proceeds we received from the July 30, 2009 registered direct offering, proceeds
we received from the exercise of common stock purchase warrants and option exercises and revenues
we expect to
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generate will be sufficient to meet our anticipated cash requirements to continue sales
and marketing and some research and development through September 30, 2010. However, in order to
execute our Microcyn product development strategy and to penetrate new and existing markets, we may
need to raise additional funds, through public or private equity offerings, debt financings,
corporate collaborations or other means. We have implemented cost cutting initiatives while
continuing to increase revenue in an effort to reach cash breakeven.
We believe that we have access to capital resources through possible public or private equity
offerings, debt financings, corporate collaborations or other means; however, we have not secured
any commitment for new financing at this time, nor can we provide any assurance that new financing
will be available on commercially acceptable terms, if needed. If we are unable to secure
additional capital, we may be required to curtail our research and development initiatives and take
additional measures to reduce costs in order to conserve cash.
Sources of Liquidity
As of September 30, 2009, we had unrestricted cash and cash equivalents of $6,452,000. Since
our inception, substantially all of our operations have been financed through sales of equity
securities. Other sources of financing that we have used to date include our revenues, as well as
various loans.
Since our inception, substantially all of our operations have been financed through the sale
of $111,525,000 (net proceeds) of our common and convertible preferred stock. This includes:
| net proceeds $21,936,000 raised in our initial public offering on January 30, 2007; | ||
| net proceeds of $9,124,000 raised in a private placement of common shares on August 13, 2007; | ||
| net proceeds of $12,613,000 raised through a registered direct placement from March 31, 2008 to April 1, 2008; | ||
| net proceeds of $1,514,000 raised through a private placement on February 6, 2009; | ||
| net proceeds of $948,000 from a private placement on February 24, 2009; | ||
| net proceeds of $2,000,000 from a private placement on June 1, 2009; | ||
| net proceeds of $5,411,000 from a registered direct offering on July 30, 2009; and | ||
| $1,053,000 received from the exercise of common stock purchase warrants and options during the three months ended September 30, 2009. |
In June 2006, we entered into a loan and security agreement with a financial institution to
borrow a maximum of $5,000,000. Under this facility we borrowed $4,182,000. The loan was repaid in
full at March 31, 2009.
Cash Flows
As of September 30, 2009, we had cash and cash equivalents of $6,452,000, compared to
$1,921,000 at March 31, 2009.
Net cash used in operating activities during the six months ended September 30, 2009 was
$3,355,000, primarily due to the $5,434,000 net loss for the period. These uses of cash were offset
in part by non-cash charges during the year ended September 30, 2009, including $757,000 loss on
the fair value of warrants, $906,000 of stock-based compensation, and $237,000 of depreciation and
amortization.
Net cash used in operating activities during the six months ended September 30, 2008 was
$11,665,000 primarily due to the $12,111,000 net loss for the period, and to a $1,676,000 decrease
in accounts payable, primarily the result of payments made for the placement fee of our registered
direct fundraising in March 2008 that were outstanding at March 31, 2008, and to a lesser extent a
$809,000 decrease in accrued expenses, related to the payments made on accrued bonuses earned
during the fiscal year ended March 31, 2008. These uses of cash were offset in part by non-cash
charges during the six months ended September 30, 2008, including $1,911,000 of stock-based
compensation, $444,000 of depreciation and amortization and $214,000 of non-cash interest expense,
and $217,000 of loss on the disposal of capital equipment.
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Net cash used in investing activities was $101,000 and $253,000 for the six months ended
September 30, 2009 and 2008, respectively.
Net cash provided by financing activities was $7,984,000 for the six months ended September
30, 2009. We received net proceeds
from the sale of common stock during this period of $7,159,000. Additionally, we received
proceeds of $1,053,000 related to the exercise of common stock purchase warrants and stock options.
Net cash used in financing activities was $918,000 for the six months ended September 30, 2008.
This involved debt payments totaling $940,000 and $36,000 of net funds received in connection with
the issuance of common stock.
Operating Capital and Capital Expenditure Requirements
We incurred a net loss of $5,434,000 for the six months ended September 30, 2009. At September
30, 2009 our accumulated deficit amounted to $114,239,000. At September 30, 2009, our working
capital amounted to $6,373,000.
We currently anticipate that our cash and cash equivalents, the proceeds we received from the
July 30, 2009 registered direct offering, the proceeds we received from the exercise of common
stock purchase warrants and option exercises during the six months ended September 30, 2009, and
revenues we expect to generate will be sufficient to meet our anticipated cash requirements to
continue sales and marketing and some research and development through September 30, 2010. However,
in order to execute our Microcyn product development strategy and to penetrate new and existing
markets, we may need to raise additional funds, through public or private equity offerings, debt
financings, corporate collaborations or other means. We have implemented cost cutting initiatives
while continuing to increase revenue in an effort to reach cash breakeven. We may raise additional
capital to pursue its product development initiatives and penetrate markets for the sale of its
products.
We believe that we have access to capital resources through possible public or private equity
offerings, debt financings, corporate collaborations or other means; however, we have not secured
any commitment for new financing at this time, nor can we provide any assurance that new financing
will be available on commercially acceptable terms, if needed. If we are unable to secure
additional capital, we may be required to curtail our research and development initiatives and take
additional measures to reduce costs in order to conserve cash.
Our future funding requirements will depend on many factors, including:
| the scope, rate of progress and cost of our research and development activities; | ||
| future clinical trial results; | ||
| the terms and timing of any collaborative, licensing and other arrangements that we may establish; | ||
| the cost and timing of regulatory approvals; | ||
| the cost and delays in product development as a result of any changes in regulatory oversight applicable to our products; | ||
| the cost and timing of establishing sales, marketing and distribution capabilities; | ||
| the effect of competing technological and market developments; | ||
| the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and | ||
| the extent to which we acquire or invest in businesses, products and technologies. |
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosures of
contingent liabilities at the dates of the consolidated financial statements and the reported
amounts of revenues and expenses during the reporting periods. Actual results could differ from
these estimates. These estimates and assumptions include reserves and write-downs related to
receivables and inventories, the recoverability of long-term assets, deferred taxes and related
valuation allowances and valuation of equity instruments.
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Off-Balance Sheet Transactions
We currently have no off-balance sheet arrangements that have or are reasonably likely to have
a current or future material effect on our financial condition, changes in financial condition,
revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Smaller reporting companies are not required to provide the information required by this Item.
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,
or 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. Our disclosure controls and procedures have been designed to 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.
Under the supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, we have evaluated the effectiveness of our
disclosure controls and procedures as required by Exchange Act Rule 13a-15(b) as of the end of the
period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief
Financial Officer have concluded that these disclosure controls and procedures are effective at the
reasonable assurance level.
(b) Changes in internal controls. There was no changes in our internal control over financial
reporting that occurred during the fiscal quarter ended September 30, 2009 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
Our Company, on occasion, may be involved in legal matters arising in the ordinary course of
its business. While management believes that such matters are currently insignificant, matters
arising in the ordinary course of business for which we are or could become involved in litigation
may have a material adverse effect on its business, financial condition or results of operations.
ITEM 1A: Risk Factors
There have been no material changes from risk factors previously disclosed in our Annual
Report on Form 10-K for the fiscal year ended March 31, 2009, as filed with the SEC on June 11,
2009, except as follows:
We have a history of losses, we expect to continue to incur losses and we may never achieve
profitability.
We incurred a net loss of 1,893,000 and $5,434,000 for the three and six months ended
September 30, 2009, respectively. At September 30, 2009, our accumulated deficit amounted to
$114,239,000. During the three months ended September 30, 2009, net cash
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used in operating
activities amounted to $3,355,000. At September 30, 2009, our working capital amounted to
$6,373,000. We may need
to raise additional capital from external sources. We expect to continue incurring losses for
the foreseeable future and may raise additional capital to pursue product development initiatives
and penetrate markets for the sale of our products. We may not raise additional capital. We believe
that we have access to capital resources through possible public or private equity offerings, debt
financings, corporate collaborations or other means. If the economic climate in the U.S. does not
improve or continues to deteriorate, our ability to raise additional capital could be negatively
impacted. If we are unable to secure additional capital, we may be required to curtail our research
and development initiatives and take additional measures to reduce costs in order to conserve cash.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On February 24, 2009, we entered into a Purchase Agreement with Robert Burlingame, our
director, and an accredited investor (the Investors). Pursuant to the terms of the Purchase
Agreement, the Investors agreed to make a $3,000,000 investment. The Investors paid $1,000,000 on
February 24, 2009 and paid the remaining $2,000,000 on June 1, 2009. In exchange for this
investment, we issued to the Investors a total of 2,564,103 shares of our common stock in two
tranches, pro rata to the investment amounts paid by the Investor on each date the Investor
provided funds. In connection with this offering, we issued 854,701 shares of our common stock on
February 27, 2009 and 1,709,402 shares of our common stock on June 1, 2009. In addition, we issued
to the Investors Series A Warrants, exercisable after six months for a five year term, to purchase
a total of 1,500,000 shares of our common stock at an exercise price of $1.87 per share and Series
B Warrants, exercisable after six months for a three year term, to purchase a total of 2,000,000
shares of our common stock at an exercise price of $1.13 per share. Both the Series A and Series B
Warrants are exercisable in tranches, pro rata to the investment amounts paid by the Investors on
the closing dates. In connection with this placement, we paid Merriman Curhan Ford and Co. a fee of
$50,000 for their assistance with the transaction.
We have used, or intend to use, the proceeds from the offerings described above principally
for general corporate purposes, including working capital.
On May 27, 2009, we issued 24,500 shares of common stock to Advocos in connection with an
agreement whereby Advocos will provide product sales services.
On June 12, 2009, we issued Robert Burlingame, a member of our board of directors, 435,897
shares of our common stock pursuant to a consulting agreement entered into on April 1, 2009,
whereby Mr. Burlingame provides us with sales and marketing expertise and other services.
On September 24, 2009, we issued 5,600 shares of common stock to Advocos as compensation for
product sales services performed in connection with an agreement between us and Advocos.
With respect to the sale of our common stock described above, we relied on the Section 4(2)
exemption from securities registration under the federal securities laws for transactions not
involving any public offering. No advertising or general solicitation was employed in offering the
shares. The shares were sold to accredited investors. The shares were offered for investment
purposes only and not for the purpose of resale or distribution, and the transfer thereof was
appropriately restricted by us.
Item 3. Default Upon Senior Securities
We did not default upon any senior securities during the quarter ended September 30, 2009.
Item 4. Submission of Matters to a Vote of the Security Holders
On September 10, 2009 we held our 2009 Annual Meeting of Stockholders where our stockholders
voted on the following matters:
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Election of Directors to the Board of Directors
Our stockholders re-elected Robert Burlingame and James Schutz to serve as directors on our
board of directors. The voting information is as follows:
Robert Burlingame |
||||
FOR |
15,953,520 | |||
WITHHELD |
538,909 | |||
James Schutz |
||||
FOR |
15,976,145 | |||
WITHHELD |
516,284 |
In addition to the nominees re-elected to serve on the board, the following directors continued to
serve on the board following the Annual Meeting: Hojabr Alimi, Gregg Alton, Jay Birnbaum, Richard
Conley and Gregory French.
Approval of the Amendment to our Amended and Restated 2006 Stock Incentive Plan
Our stockholders approved the amendment to our Amended and Restated 2006 Stock Incentive Plan
pursuant to which the number of shares available for issuance was increased from 3,557,641 to
4,557,641. The voting information on the matter is as follows:
FOR |
6,919,499 | |||
AGAINST |
827,171 | |||
ABSTAIN |
91,607 |
Ratification of the Appointment by the Audit Committee of the Board of Directors of Marcum LLP as
our Independent Registered Public Accountants
Our stockholders ratified the appointment by our audit committee of the board of directors of
Marcum LLP as our independent registered public accountants for the 2010 fiscal year. The voting
information on the matter is as follows:
FOR |
16,293,355 | |||
AGAINST |
136,662 | |||
ABSTAIN |
62,412 |
Item 5. Other Information
None.
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Item 6. Exhibits
Exhibit | ||
Number | Description | |
3.1(i)
|
Restated Certificate of Incorporation of Registrant (incorporated by reference to the exhibit of the same number filed with the Companys Annual Report on Form 10-K (File No. 001-3216) for the year ended March 31, 2007). | |
3.1(ii)
|
Amended and Restated Bylaws of Registrant, as amended effective June 11, 2008 (incorporated by reference to the exhibit of the same number filed with the Companys Annual Report on Form 10-K (File No. 001-3216) for the year ended March 31, 2007). | |
4.1
|
Specimen Common Stock Certificate (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.2
|
Warrant to Purchase Series A Preferred Stock of Registrant by and between Registrant and Venture Lending & Leasing III, Inc., dated April 21, 2004 (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.3
|
Warrant to Purchase Series B Preferred Stock of Registrant by and between Registrant and Venture Lending & Leasing IV, Inc., dated June 14, 2006 (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.4
|
Form of Warrant to Purchase Common Stock of Registrant (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.5
|
Form of Warrant to Purchase Common Stock of Registrant (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.6
|
Amended and Restated Investors Rights Agreement, effective as of September 14, 2006 (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.7
|
Form of Promissory Note issued to Venture Lending & Leasing III, Inc. (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.8
|
Form of Promissory Note (Equipment and Soft Cost Loans) issued to Venture Lending & Leasing IV, Inc. (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.9
|
Form of Promissory Note (Growth Capital Loans) issued to Venture Lending & Leasing IV, Inc. (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.10
|
Form of Promissory Note (Working Capital Loans) issued to Venture Lending & Leasing IV, Inc. (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.11
|
Form of Warrant to Purchase Common Stock of Registrant (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.12
|
Form of Warrant to Purchase Common Stock of Registrant (incorporated by reference to the exhibit of the same number filed with Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007). | |
4.13
|
Form of Warrant to Purchase Common Stock of Registrant (incorporated by reference to exhibit 10.3 to the Companys Current Report on Form 8-K filed August 13, 2007). | |
4.14
|
Form of Warrant to Purchase Common Stock of Registrant (incorporated by reference to exhibit 4.1 to the Companys Current Report on Form 8-K filed March 28, 2008). | |
4.15
|
Form of Common Stock Purchase Warrant for July 2009 offering (included as exhibit 4.15 to the Form S-1 filed July 9, 2009 and incorporated herein by reference). | |
4.16
|
Warrant issued to Dayl Crow, dated March 4, 2009 (included as exhibit 4.16 to the Form 10-K filed June 11, 2009 and incorporated herein by reference). | |
31.1*
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2*
|
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1*#
|
Certification of Officers pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
* | Filed herewith. |
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# | In accordance with Item 601(b)(32)(ii) of Regulation S-K 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 Exhibit 32.1 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. |
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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. |
||||
Date: November 9, 2009 | By: | /s/ Hojabr Alimi | ||
Hojabr Alimi | ||||
Its: | Chairman of the Board of Directors and Chief Executive Officer (Principal Executive Officer) | |||
Date: November 9, 2009 | By: | /s/ Robert Miller | ||
Robert Miller | ||||
Its: | Chief Financial Officer (Principal Financial Officer) |
|||
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