Sonoma Pharmaceuticals, Inc. - Quarter Report: 2009 June (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 June 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 (State or other jurisdiction of incorporation or organization) |
68-0423298 (I.R.S Employer 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)
Registrants telephone number, including area code (707) 782-0792
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 | Smaller reporting company þ | |||
(Do not check if a smaller reporting company) |
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 August 4, 2009 the number of shares outstanding of the registrants common stock, $0.0001 par
value, was 23,036,342.
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)
(In thousands, except share and per share amounts)
PART I: FINANCIAL INFORMATION
Item 1. | Financial Statements |
June 30, | March 31, | |||||||
2009 | 2009 | |||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 2,053 | $ | 1,921 | ||||
Accounts receivable, net |
1,293 | 923 | ||||||
Inventories |
355 | 340 | ||||||
Prepaid expenses and other current assets |
667 | 758 | ||||||
Total current assets |
4,368 | 3,942 | ||||||
Property and equipment, net |
1,350 | 1,432 | ||||||
Deferred offering costs |
54 | | ||||||
Other assets |
104 | 73 | ||||||
Total assets |
$ | 5,876 | $ | 5,447 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,319 | $ | 1,565 | ||||
Accrued expenses and other current liabilities |
1,440 | 853 | ||||||
Current portion of long-term debt |
175 | 255 | ||||||
Current portion of capital lease obligations |
4 | 6 | ||||||
Total current liabilities |
2,938 | 2,679 | ||||||
Deferred revenue |
401 | 425 | ||||||
Long-term debt, less current portion |
65 | 74 | ||||||
Derivative liability |
1,531 | | ||||||
Total liabilities |
4,935 | 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 June 30, 2009
(unaudited) and March 31, 2009 |
| | ||||||
Common stock, $0.0001 par value; 100,000,000
shares authorized, 20,572,619 and 18,402,820
shares issued and outstanding at June 30,
2009 (unaudited) and March 31, 2009,
respectively |
2 | 2 | ||||||
Additional paid-in capital |
116,268 | 113,803 | ||||||
Accumulated other comprehensive loss |
(2,983 | ) | (3,054 | ) | ||||
Accumulated deficit |
(112,346 | ) | (108,482 | ) | ||||
Total stockholders equity |
941 | 2,269 | ||||||
Total liabilities and stockholders equity |
$ | 5,876 | $ | 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)
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended | ||||||||
June 30, | ||||||||
2009 | 2008 | |||||||
Revenues |
||||||||
Product |
$ | 1,567 | $ | 1,007 | ||||
Service |
280 | 204 | ||||||
Total revenues |
1,847 | 1,211 | ||||||
Cost of revenues |
||||||||
Product |
527 | 438 | ||||||
Service |
215 | 198 | ||||||
Total cost of revenues |
742 | 636 | ||||||
Gross profit |
1,105 | 575 | ||||||
Operating expenses |
||||||||
Research and development |
721 | 2,321 | ||||||
Selling, general and administrative |
2,685 | 3,328 | ||||||
Total operating expenses |
3,406 | 5,649 | ||||||
Loss from operations |
(2,301 | ) | (5,074 | ) | ||||
Interest expense |
(4 | ) | (162 | ) | ||||
Interest income |
1 | 76 | ||||||
Change in
fair value of derivative instruments |
(1,208 | ) | | |||||
Other expense, net |
(29 | ) | (39 | ) | ||||
Net loss |
$ | (3,541 | ) | $ | (5,199 | ) | ||
Net loss per common share: basic and diluted |
$ | (0.18 | ) | $ | (0.33 | ) | ||
Weighted-average number of shares used in per common share calculations: |
||||||||
Basic and diluted |
19,388 | 15,924 | ||||||
Other comprehensive loss, net of tax |
||||||||
Net loss |
$ | (3,541 | ) | $ | (5,199 | ) | ||
Foreign currency translation adjustments |
71 | 18 | ||||||
Other comprehensive loss |
$ | (3,470 | ) | $ | (5,181 | ) | ||
See accompanying notes
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OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(In thousands)
(In thousands)
(Unaudited)
Three Months Ended | ||||||||
June 30, | ||||||||
2009 | 2008 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (3,541 | ) | $ | (5,199 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
123 | 248 | ||||||
Stock-based compensation |
465 | 456 | ||||||
Change in
the fair value of derivative liability |
1,208 | | ||||||
Non-cash interest expense |
| 107 | ||||||
Foreign currency transaction (gains) losses |
(16 | ) | 5 | |||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
(306 | ) | (67 | ) | ||||
Inventories |
2 | (17 | ) | |||||
Prepaid expenses and other current assets |
114 | 2 | ||||||
Accounts payable |
(273 | ) | (1,188 | ) | ||||
Accrued expenses and other liabilities |
530 | (1,115 | ) | |||||
Net cash used in operating activities |
(1,694 | ) | (6,768 | ) | ||||
Cash flows from investing activities: |
||||||||
Changes in restricted cash |
| 24 | ||||||
Changes in long-term deposits |
(26 | ) | | |||||
Purchases of property and equipment |
(15 | ) | (183 | ) | ||||
Net cash used in investing activities |
(41 | ) | (159 | ) | ||||
Cash flows from financing activities: |
||||||||
Proceeds from the issuance of common stock, net of offering costs |
2,000 | 36 | ||||||
Deferred offering costs |
(54 | ) | | |||||
Principal payments on debt |
(89 | ) | (464 | ) | ||||
Payments on capital lease obligations |
(2 | ) | (4 | ) | ||||
Net cash provided by (used in) financing activities |
1,855 | (432 | ) | |||||
Effect of exchange rate on cash and cash equivalents |
12 | (9 | ) | |||||
Net increase (decrease) in cash and cash equivalents |
132 | (7,368 | ) | |||||
Cash and equivalents, beginning of period |
1,921 | 18,823 | ||||||
Cash and equivalents, end of period |
$ | 2,053 | $ | 11,455 | ||||
Supplemental disclosure of cash flow information: |
||||||||
Cash paid for interest |
$ | 4 | $ | 59 | ||||
See accompanying notes
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OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(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 June 30, 2009 and
for the three 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 June 30, 2009, condensed consolidated
statements of operations for the three months ended June 30, 2009 and 2008, and the condensed
consolidated statements of cash flows for the three months ended June 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 months ended June 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 $58,000 and $55,000, which are included in accounts receivable, net in the
accompanying June 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 Statement of Financial Accounting Standard (SFAS) No. 52, Foreign Currency Translation
(SFAS 52). 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 June 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 $16,000
and $(5,000) for the three months ended June 30, 2009 and 2008, respectively. The related gains
(losses) were
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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 SFAS No. 128, basic net loss per
share is computed by dividing net loss per share available to common stockholders by the weighted
average number of common shares outstanding for the period and excludes the effects of any
potentially dilutive securities. Diluted earnings per share, if presented, would include the
dilution that would occur upon the exercise or conversion of all potentially dilutive securities
into common stock using the treasury stock and/or if converted methods as applicable. The
computation of basic loss per share for the three months ended June 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):
June 30, | ||||||||
2009 | 2008 | |||||||
Options to purchase common stock |
3,929 | 2,694 | ||||||
Restricted stock units |
30 | 60 | ||||||
Warrants to purchase common stock |
9,407 | 3,321 | ||||||
13,366 | 6,075 | |||||||
Common Stock Purchase Warrants and Other Derivative Financial Instruments
The Company accounts for the issuance of common stock purchase warrants issued and other free
standing derivative financial instruments in accordance with the provisions of EITF 00-19
Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a
Companys Own Stock (EITF 00-19). Based on the provisions of EITF 00-19, the Company classifies
as equity any contracts that (i) require physical settlement or net-share settlement or (ii) gives
the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or
net-share settlement). The Company classifies as assets or liabilities any contracts that (i)
require net-cash settlement (including a requirement to net cash settle the contract if an event
occurs and if that event is outside the control of the Company) or (ii) gives the counterparty a
choice of net-cash settlement or settlement in shares (physical settlement or net-share
settlement). 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 June 30,
2009 and March 31, 2009 other than certain warrants that contain reset provisions that the Company
classified as derivative liabilities upon its adoption of EITF 07-5 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 Statement of Financial Accounting Standards No. 157, Fair Value Measurements (Statement No.
157) which defines fair value, establishes a framework for measuring fair value, and expands
disclosures about fair value measurements. Effective April 1, 2009, the Company adopted the
provisions of Statement No. 157 for financial assets and liabilities, as well as for any other
assets and liabilities that are carried at fair value on a recurring basis.
Statement No. 157 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. Statement No. 157 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. Statement No. 157 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 | |||
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) |
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Financial liabilities measured at fair value on a recurring basis are summarized below:
Fair value measurements at June 30, 2009 using | ||||||||||||
Quoted prices in | Significant | |||||||||||
active markets | other | Significant | ||||||||||
for | observable | unobservable | ||||||||||
June 30, | identical assets | inputs | inputs | |||||||||
2009 | (Level 1) | (Level 2) | (Level 3) | |||||||||
Liabilities: |
||||||||||||
Fair value of warrant obligations (Note 5)
|
1,531,000 | | | 1,531,000 |
Subsequent
Events
Management has evaluated
subsequent events or transactions occurring through August 7, 2009, the date the financial statements were issued.
Recent Accounting Pronouncements
In May 2008, the FASB issued FASB Staff Position (FSP) APB 14-1, Accounting for Convertible
Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement)
This FSP clarifies that convertible debt instruments that may be settled in cash upon conversion
(including partial cash settlement) are not addressed by paragraph 12 of APB Opinion No. 14,
Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants. Additionally, this
FSP specifies that issuers of such instruments should separately account for the liability and
equity components in a manner that will reflect the entitys nonconvertible debt borrowing rate
when interest cost is recognized in subsequent periods. This FSP is effective for financial
statements issued for fiscal years beginning after December 15, 2008, and interim periods within
those fiscal years. The adoption of this FSP did not have an impact on the Companys condensed
consolidated financial statements.
In June 2008, the FASB issued FSP EITF 03-6-1, Determining Whether Instruments Granted in
Share-Based Payment Transactions Are Participating Securities. This FSP addresses whether
instruments granted in share-based payment transactions are participating securities prior to
vesting and, therefore, need to be included in the earnings allocation in computing earnings per
share (EPS) under the two-class method described in paragraphs 60 and 61 of FASB Statement No. 128,
Earnings per Share. FSP EITF 03-6-1 is effective for financial statements issued for fiscal years
beginning after December 15, 2008, and interim periods within those years. The adoption of this FSP
did not have an impact on the Companys condensed consolidated financial statements.
In December 2008, the FASB ratified EITF Issue No. 07-5, Determining Whether an Instrument
(or Embedded Feature) Is Indexed to an Entitys Own Stock. 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 EITF 07-5 in its June 30, 2009
condensed consolidated financial statements (Note 5).
In April 2009, the FASB issued
FSP SFAS 157-4, Determining Whether a Market Is Not
Active and a Transaction Is Not Distressed,
(FSP FAS 157-4)
which provides guidelines for making fair value measurements more consistent with the principles presented in SFAS 157.
FSP FAS 157-4 provides additional authoritative guidance in determining whether a market is active or inactive and
whether a transaction is distressed, is applicable to all assets and liabilities (i.e. financial and nonfinancial)
and will require enhanced disclosures. This standard is effective for periods ending after June 15, 2009. The
adoption of this policy did not have a material impact on the Company's condensed consolidated financial position
and condensed consolidated results of operations.
In April 2009, the FASB issued FSP SFAS 107-1 and APB 28-1,
Interim Disclosures about Fair Value of Financial
Instruments, (FSP FAS 107-1 and
APB 28-1). FSP FAS 107-1 and
APB 28-1 amends SFAS No. 107, Disclosures about Fair
Value of Financial Instruments, to require disclosures about
fair value of financial instruments in interim as well as in annual
financial statements. FSP FAS 107-1 and APB 28-1
amends APB Opinion No. 28, Interim Financial
Reporting, to require those disclosures in all interim financial statements.
This standard is effective for periods ending after June 15, 2009. The adoption of this policy did not have a material
impact on the Companys condensed consolidated financial position and condensed consolidated results of operations.
In May 2009, the FASB issued
SFAS 165, Subsequent Events (SFAS 165), which provides guidance on events that occur after the balance sheet date
but prior to the issuance of the financial statements. SFAS 165 distinguishes events requiring recognition in the
financial statements and those that may require disclosure in the financial statements. Furthermore, SFAS 165 requires
disclosure of the date through which subsequent events were evaluated. SFAS 165 is effective for interim and annual
periods after June 15, 2009. The adoption of this policy did not have a material impact on the Companys condensed
consolidated financial position and condensed consolidated results of
operations.
In July 2009, the FASB issued
Statement of Financial Accounting Standards No. 168, The FASB Accounting Codification and the Hierarchy of Generally
Accepted Accounting Principles (SFAS. 168). Statement No. 168 supersedes Statement No. 162 issued in May 2008.
Statement No. 168 will become the source of authoritative U.S. generally accepted accounting principles (GAAP) recognized
by the FASB to be applied by nongovernmental entities. Rules and interpretive releases of the Securities and Exchange
Commission (SEC) under authority of federal securities laws are also sources of authoritative GAAP for SEC registrants.
On the effective date of this Statement, the Codification will supersede all then-existing non-SEC accounting and
reporting standards. All other nongrandfathered non-SEC accounting literature not included in the Codification will
become nonauthoritative. This Statement is effective for our quarterly reporting period ending September 30, 2009.
The adoption of Statement No. 168 is not expected to have any impact the Company's condensed consolidated financial
position or condensed consolidated results of operations.
Other accounting standards that have been issued or proposed by the FASB, the EITF, the 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 net losses of $3,541,000 for the three months ended June 30, 2009. At
June 30, 2009, the Companys accumulated deficit amounted to $112,346,000. The Company had working
capital of $1,430,000 as of June 30, 2009.
On June 1, 2009, the Company issued the remaining securities related to 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
1,227,000 shares of common stock at an exercise price of $3.3875 per share for gross proceeds of
$6,012,000 (net proceeds of $5,411,000 after deducting the placement agents commissions).
The Company currently anticipates that its cash and cash equivalents, the proceeds from the
July 30, 2009 registered direct offering 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 June 30, 2010. However, in order to execute the 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.
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The Company has used, or intends to use, the proceeds from the offerings described above
principally for general corporate purposes, including working capital.
Note 3. Condensed Consolidated Balance Sheet
Inventories
Inventories consisted of the following (in thousands):
June 30, | March 31, | |||||||
2009 | 2009 | |||||||
Raw materials |
$ | 313 | $ | 277 | ||||
Finished goods |
137 | 134 | ||||||
450 | 411 | |||||||
Less: inventory allowances |
(95 | ) | (71 | ) | ||||
$ | 355 | $ | 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 June 30, 2009, the Company made principal and interest
payments related to these notes in the amounts of $89,000 and $4,000, respectively. The remaining
balance of these notes amounted to $240,000 at June 30, 2009 of which $175,000 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.
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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 June 30, 2009, the Company has entered into 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 June 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 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 the first cash installments which were due May 1, 2009.
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 June 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 June 30, 2009 and 2008, the Company amortized $24,000 of
deferred revenue related to these agreements which is 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 space from September 30, 2010 to September 30, 2011. The
Company also agreed to provide the property owner a settlement in the
form of a cash payment
of $50,000 no later than August 14, 2009 and at the option of the Company, no later
than August 17, 2009, the property owner will either receive 53,847 shares of the Companys common
stock or a $70,000 cash payment. The value of the settlement will be
amortized on a straight-line basis over the remaining term of the
lease, or September 30, 2011.
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.
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Due to its liquidity circumstances, QP was unable to sustain operations without the Companys
subordinated financial and management support. Accordingly, QP was deemed to be a variable interest
entity in accordance with FIN 46(R) and its results were consolidated with the Companys
consolidated financial statements for the period of 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 June 2008, the FASB finalized Emerging Issues Task Force (EITF) 07-05, Determining
Whether an Instrument (or Embedded Feature) is indexed to an Entitys Own Stock. Under EITF
07-05, 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. 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 EITF 07-05, the warrants were recognized as a derivative instrument
and have been re-characterized as derivative liabilities. SFAS No. 133, Accounting for Derivative
Instruments and Hedging Activities (FAS 133) 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:
June 30, | April 1, | |||||||
2009 | 2009 | |||||||
Expected life |
3.12 years | 3.37 years | ||||||
Risk-free interest rate |
1.64 | % | 1.15 | % | ||||
Dividend yield |
0.00 | % | 0.00 | % | ||||
Volatility |
85 | % | 84 | % | ||||
Warrants issued with private placement |
953,752 | 953,752 | ||||||
Fair value of warrants |
$ | 1,531,000 | $ | 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 $1,531,000 as of June 30, 2009. Accordingly, the Company increased the derivative liability by
$1,208,000 to reflect the change in fair value for the three months ended June 30, 2009. This
amount is included as a loss on derivative instruments in the accompanying condensed consolidated
statement of operations for the three months ended June 30, 2009.
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Note 6. Stockholders Equity
Common Stock Issued to Non-Employee 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 Issue 2 of EITF 96-18
Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services, 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 $475,000 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 months ended June
30, 2009, the Company recorded $238,000 in selling, general and administrative expense in the
accompanying condensed consolidated statement 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. Additionally, the
Company agreed to issue the CSO 7,000 shares of common stock each month as compensation for their
services. On May 27, 2009, the Company issued 24,500 shares of common stock in connection with
this agreement that represents compensation through July 31, 2009. The Company has determined the
fair value of the common stock, which will be calculated as shares are issued, will be more readily
determinable than the fair value of the services rendered. Accordingly, the Company will record
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 months ended June 30, 2009, the Company recorded
$26,000 in selling, general and administrative expense in the accompanying condensed consolidated
statement 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.
Anti-dilution adjustment
Pursuant to an anti-dilution provision contained in both the August 13, 2007 private placement
investor and placement agent warrant agreements, during the three months ended June 30, 2009, the
Company was required to adjust the exercise price and the number of warrants held by each warrant
holder. The adjustment was the result of the issuance of 480,397 shares of common stock to certain
consultants in consideration for their services. The exercise price for the warrants was adjusted
from $5.03 to $4.94 and an additional 17,425 warrants were issued.
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Note 7. Stock-Based Compensation
Prior to April 1, 2006, the Company accounted for stock-based employee compensation
arrangements in accordance with the provisions of APB No. 25, Accounting for Stock Issued to
Employees, (APB 25) and its related interpretations and applied the disclosure requirements of
SFAS No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure, an amendment of
Statement of Financial Accounting Standard No. 123 Share-Based Payments (SFAS 123). The
Company used the minimum value method to measure the fair value of awards issued prior to April 1,
2006 with respect to its application of the disclosure requirements under SFAS 123.
The Company recognized in salaries and related expense in the condensed consolidated
statements of operations $7,600 and $36,000 of stock-based compensation expense during the three
months ended June 30, 2009 and 2008, respectively, which represents the intrinsic value
amortization of options granted prior to April 1, 2006 that the Company is continuing to account
for using the recognition and measurement principles prescribed under APB 25. At June 30, 2009,
there was $17,000 of unrecognized compensation cost related to options that the Company accounted
for under APB 25 through March 31, 2006. These costs are expected to be recognized over a weighted
average remaining amortization period of one-third year.
Effective April 1, 2006, the Company adopted Statement of Financial Accounting Standard No.
123(R) Share Based Payment (SFAS 123(R)) using the prospective transition method, which
requires the fair value measurement and recognition of compensation expense for all share-based
payment awards granted, modified and settled to the Companys employees and directors after April
1, 2006. The Companys condensed consolidated financial statements as of March 31, 2009 and for the
three months ended June 30, 2009 and 2008, reflect the impact of SFAS 123(R).
The effect of recording stock-based compensation expense in accordance with the provisions of
SFAS 123(R) is as follows (in thousands, except per share amounts):
Three Months | ||||||||
Ended | ||||||||
June 30, | ||||||||
2009 | 2008 | |||||||
Cost of service revenue |
$ | 4 | $ | 3 | ||||
Research and development |
29 | 52 | ||||||
Selling, general and administrative |
160 | 321 | ||||||
Total stock-based compensation |
$ | 193 | $ | 376 | ||||
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 Company estimated the fair value of employee stock awards using the Black-Scholes option
pricing model. The fair value of employee stock options is being amortized on a straight-line basis
over the requisite service period of the awards. The fair value of employee stock options for the
three months ended June 30, 2009 was estimated using the following weighted-average assumptions:
expected term of 6.5 years, risk-free interest rate of 3.28%, and dividend yield of 0.00% and
volatility of 76%. There were no options granted during the three months ended June 30, 2009.
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 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.
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In addition, SFAS No. 123(R) requires forfeitures to be estimated at the time of grant and
revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
Forfeitures were estimated at 5% based on historical experience. Prior to the adoption of SFAS No.
123(R), the Company accounted for forfeitures as they occurred.
A summary of all option activity as of June 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 |
| | ||||||||||||||
Exercised |
| | ||||||||||||||
Forfeited or expired |
(35 | ) | 6.72 | |||||||||||||
Outstanding at June 30, 2009 |
3,929 | $ | 3.25 | 6.73 | $ | 6,949 | ||||||||||
Exercisable at June 30, 2009 |
2,083 | $ | 4.51 | 4.71 | $ | 2,628 | ||||||||||
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 (3.52) for stock
options that were in-the-money as of June 30, 2009.
At June 30, 2009, there was unrecognized compensation costs of $1,673,000 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 2.57 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). Remaining shares authorized for issuance from the 2006 Plan at June
30, 2009 was 991,000.
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 June 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 SFAS No. 109, the valuation allowance will be reduced accordingly.
In June 2006, the Financial Accounting Standards Board (FASB) issued Interpretation 48,
Accounting for Uncertainty in Income Taxes (FIN 48), which became effective for the Company
beginning April 1, 2007. FIN 48 addresses how tax benefits claimed or expected to be claimed on a
tax return should be recorded in the financial statements. Under FIN 48, 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. The adoption of FIN 48 had no impact on the Companys financial
condition, results of operations or cash flows.
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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 FIN 48 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 FIN 48, 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 June 30, 2009 | U.S. | ROW | Mexico | Total | ||||||||||||
Product revenues |
$ | 131 | $ | 228 | $ | 1,208 | $ | 1,567 | ||||||||
Service revenues |
280 | | | 280 | ||||||||||||
Total revenues |
411 | 228 | 1,208 | 1,847 | ||||||||||||
Depreciation and amortization expense |
(75 | ) | (26 | ) | (22 | ) | (123 | ) | ||||||||
Profit (loss) from operations |
(2,540 | ) | (99 | ) | 338 | (2,301 | ) | |||||||||
Interest expense |
(4 | ) | | | (4 | ) | ||||||||||
Interest income |
1 | | | 1 |
Europe/ | ||||||||||||||||
Three months ended June 30, 2008 | U.S. | ROW | Mexico | Total | ||||||||||||
Product revenues |
$ | 65 | $ | 184 | $ | 758 | $ | 1,007 | ||||||||
Service revenues |
204 | | | 204 | ||||||||||||
Total revenues |
269 | 184 | 758 | 1,211 | ||||||||||||
Depreciation and amortization expense |
104 | 60 | 84 | 248 | ||||||||||||
Loss from operations |
(4,839 | ) | (164 | ) | (71 | ) | (5,074 | ) | ||||||||
Interest expense |
(162 | ) | | | (162 | ) | ||||||||||
Interest income |
76 | | | 76 |
Sales by geography reported in the Europe/ROW segment is as follows (in thousands):
Three Months | ||||||||
Ended | ||||||||
June 30, | ||||||||
2009 | 2008 | |||||||
India |
$ | 29 | $ | 27 | ||||
China |
106 | | ||||||
Europe and other |
93 | 157 | ||||||
Total Europe/ROW |
$ | 228 | $ | 184 | ||||
The following table shows property and equipment balances by segment (in thousands):
June 30, | March 31, | |||||||
2009 | 2009 | |||||||
U.S. |
$ | 863 | $ | 931 | ||||
Europe/ROW |
301 | 322 | ||||||
Mexico |
186 | 179 | ||||||
$ | 1,350 | $ | 1,432 | |||||
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The following table shows total asset balances by segment (in thousands):
June 30, | March 31, | |||||||
2009 | 2009 | |||||||
U.S. |
$ | 3,555 | $ | 3,543 | ||||
Europe/ROW |
731 | 841 | ||||||
Mexico |
1,590 | 1,063 | ||||||
$ | 5,876 | $ | 5,447 | |||||
Note 10. Subsequent Events
Registered Direct Offering
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
1,227,000 shares of common stock at an exercise price of $3.3875 per share for gross proceeds of
$6,012,000 (net proceeds of $5,411,000 after deducting the placement agents commissions).
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 June 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. These are statements
that relate to future periods and include statements about, but not limited to: the progress and
timing of our development programs and regulatory approvals for our products; the benefits and
effectiveness of our products; the ability of our products to meet existing or future regulatory
standards; the progress and timing of clinical trials and physician studies; our expectations
related to the use of our cash reserves; our expectations and capabilities relating to the sales
and marketing of our current products and our product candidates; our ability to compete with other
companies that are developing or selling products that are competitive with our products; the
establishment of strategic partnerships for the development or sale of products; the timing of
commercializing our products; our relationship with Quimica Pasteur; our ability to penetrate
markets through our sales force, distribution network, and strategic business partners and generate
attractive margins; the expansion of our sales force and distribution network; the ability to
attain specified revenue goals within a specified time frame, if at all, or to reduce costs; the
outcome of discussions with the FDA and other regulatory agencies; the content and timing of
submissions to, and decisions made by, the FDA and other regulatory agencies, including
demonstrating to the satisfaction of the FDA the safety and efficacy of our products; our ability
to manufacture sufficient amounts of our product candidates for clinical trials and products for
commercialization activities; our ability to protect our intellectual property and operate our
business without infringing on the intellectual property of others; our ability to continue to
expand our intellectual property portfolio; our expectations about the outcome of litigation and
controversies with third parties; our ability to attract and retain qualified directors, officers
and employees; our expectations relating to the concentration of our revenue from international
sales; our ability to expand to and commercialize products in markets outside the wound care
market; and the impact of the Sarbanes-Oxley Act of 2002 and any future changes in accounting
regulations or practices in general with respect to public companies.
Forward-looking statements are subject to risks and uncertainties that could cause actual
results to differ materially from those projected. These risks and uncertainties include, but are
not limited to 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; the 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 risks set forth under Part
II, Item 1A, Risk Factors, included in this Quarterly Report on
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Form 10-Q. 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. These are discussed in greater detail under Current Regulatory
Approvals and Clearances.
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 $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.
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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. The new 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.
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
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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.
The FDA requirements for device and drug clearances are discussed in greater detail under
Government Regulation, Medical Device Regulation, Pharmaceutical Product Regulation and Other
Regulation in the United States.
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 a partnership with
Advocos, a specialty U.S. contract sales organization. In the quarter ending December 31, 2008, we
initiated an aggressive 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. Additionally, we are in the
process
of introducing Microcyn-based consumer healthcare products both in the United States and abroad.
Initially, these will include an oral care rinse, nasal care wash and a skin hydrogel.
On January 26, 2009, we announced a strategic revenue-sharing partnership with Vetericyn, Inc.
Pursuant to this agreement, we granted Vetericyn, 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.
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 samples broadly to many hospitals
and doctors throughout many provinces in China in anticipation of a product launch after approval
for reimbursement has 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.
Comparison of Three Months Ended June 30, 2009 and 2008
Revenues
We experienced a 56% growth in product revenues and a 37% growth in our services business,
resulting in total revenues of $1,847,000 during the quarter ended June 30, 2009 compared to
$1,211,000 in the prior year period. The $560,000 increase in product revenues was due primarily to
$451,000 higher sales in Mexico, up 59% compared to the same period last year. Without the 29% drop
in the value of the peso during the quarter, the product growth in Mexico would have been 104% and
product growth worldwide would have been 89%. As a result of the swine flu epidemic in Mexico and
normal growth, unit sales of our 240-milliliter presentation, sold mostly to pharmacies in Mexico
increased 100% over the prior year to a monthly average of 57,000 units, up from 35,000 last
quarter and 28,000 in the same quarter last year and unit sales to hospitals increased 101%,
partially offset by lower selling prices. Normal growth of the 240 ml bottles represent about
38,000 to 40,000 units per month, while the units above that reflect one time purchases related to
the swine flu concerns during the quarter. Europe/ROW sales increased $44,000, up 24%, over the
prior year due to $100,000 order to China, which did not occur in the same period last year.
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The following table shows our product revenues by geographic region (in thousands):
Three Months | ||||||||||||||||
Ended June 30, | ||||||||||||||||
2009 | 2008 | Increase | Increase | |||||||||||||
U.S. |
$ | 131 | $ | 65 | $ | 66 | 103 | % | ||||||||
Europe/ROW |
228 | 184 | 44 | 24 | % | |||||||||||
Mexico |
1,208 | 758 | 450 | 59 | % | |||||||||||
Total |
$ | 1,567 | $ | 1,007 | $ | 560 | 56 | % | ||||||||
The $76,000 increase in service revenues was due to an increase in the number of tests
provided by our services business.
Gross Profit
We reported gross profit from our Microcyn products business of $1,040,000, or 66% of product
revenues, during the three months ended June 30, 2009, compared a gross profit of $569,000, or 57%,
in the prior year period. This increase was primarily due to lower costs in Europe and higher unit
volume in Mexico. Mexicos margins improved to 82% during the quarter ended June 30, 2009,
compared to 67% in the prior year period. Gross margins in Europe and US are relatively low as we
are transferring our manufacturing from Europe to the US, sustaining costs in both locations and
including severance costs in European cost of goods sold.
Research and Development Expense
Research and development expense declined $1,600,000, or 69%, to $721,000 for the three months
ended June 30, 2009, compared to $2,321,000 in the prior year period. Most of the decrease was
attributable to the elimination of the larger clinical team and related expenses, which supported
the completion of the Phase II clinical trial last year. 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 $643,000, or 19%, to $2,685,000 during
the three months ended June 30, 2009, from $3,328,000 during the three months ended June 30, 2008.
Primarily, this decrease was due to 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 U.S. and Mexico.
We expect these expenses to grow slightly in future periods as we spend more money on
expanding the sales in the U.S. market.
Interest income and expense and other income and expense, net
Interest expense decreased $158,000 to $4,000 for the three months ended June 30, 2009, from
$162,000 in the prior year period, due to the payments made on debt over the prior year. Total
outstanding debt decreased to $244,000 at June 30, 2009, from $335,000 at March 31, 2009. Interest
income decreased $75,000, to $1,000 for the three months ended June 30, 2009, from $76,000 in the
prior year period, primarily due to the decrease in our interest bearing cash balance.
Other income and expense, net decreased $10,000 to net other expense of 29,000 for the three
months ended June 30, 2009, from net other expense of $39,000 for the same period last year.
Loss on derivative liability
As a result of our adoption of EITF 07-05 on April 1, 2009, for the three months ended June
30, 2009 we incurred a loss on derivative liabilities of $1,208,000. For the three months ended
June 30, 2008 we did not record a loss related to derivative instruments.
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Net Loss
Net loss for the three months ended June 30, 2009 was $3,541,000, down $1,658,000 from
$5,199,000 for the same period in the prior year. Stock compensation expense for the quarter ended
June 30, 2009 and 2008 were $465,000 and $456,000, respectively. Also, the accounting loss of
$1,208,000 relating to the adoption of EITF 07-05 was a non-cash charge.
Liquidity and Capital Resources
At June 30, 2009, our
accumulated deficit amounted to $112,346,000. We had working capital of
$1,430,000 as of June 30, 2009. We currently anticipate that our cash and cash equivalents, the
proceeds we received from the July 30, 2009 registered direct offering 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 June 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 June 30, 2009, we had unrestricted cash and cash equivalents of $2,053,000. 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 $105,061,000 (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 and net proceeds of
$948,000 from a private placement on February 24, 2009 and proceeds of $2,000,000 from a private
placement on June 1, 2009.
On July 30, 2009, we 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 1,227,000
shares of common stock at an exercise price of $3.3875 per share for gross proceeds of $6,012,000
(net proceeds of $5,411,000 after deducting the placement agents commissions).
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 June 30, 2009, we had unrestricted cash and cash equivalents of $2,053,000, compared to
$1,921,000 at March 31, 2009.
Net cash used in operating activities during the three months ended June 30, 2009 was
$1,694,000, primarily due to the $3,541,000 net loss for the period, and to a $273,000 decrease in
accounts payable, and a $306,000 increase in accounts receivable. These uses of cash were offset in
part by non-cash charges during the year ended June 30, 2009, including $1,208,000 loss on the fair
value of warrants, $465,000 of stock-based compensation, $123,000 of depreciation and amortization,
and an increase in accrued and other liabilities of $530,000. Net cash used in operating activities
during the quarter ended June 30, 2008 was $6,768,000, primarily due to the $5,199,000 net loss for
the period, $1,188,000 decrease in accounts payable, a decrease of $1,115,000 in accrued expenses
and
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slight increases in accounts receivables and inventories. These uses of cash were offset in
part by non-cash charges during the quarter ended June 30, 2008,
including $456,000 of stock-based compensation, $248,000 of depreciation and amortization and
$107,000 of non-cash interest expense.
Net cash used in investing activities was $41,000 and $159,000 for the three months ended June
30, 2009 and 2008, respectively.
Net cash provided by financing activities was $1,855,000 for the three months ended June 30,
2009. Stock was issued for $2,000,000, offset by $54,000 of deferred offering costs, and $89,000 of
outstanding debt was paid off during the period. Net cash used in financing activities was $432,000
for the quarter ended June 30, 2008. This involved debt payments totaling $468,000, 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 $3,541,000
for the quarter ended June 30, 2009. At June 30, 2009 our
accumulated deficit amounted to $112,346,000. At June 30, 2009, our working capital amounted to
$1,430,000.
We currently anticipate that our
cash and cash equivalents, the proceeds we received from the
July 30, 2009 registered direct offering 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 June 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. |
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
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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 the 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, the 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 were no changes in our internal control over financial
reporting that occurred during the fiscal quarter ended June 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
The Company, on occasion, is involved in legal matters arising in the ordinary course of its
business. While management believes that such matters are currently insignificant, there can be no
assurance that matters arising in the ordinary course of business for which the Company is or could
become involved in litigation will not have a material adverse effect on its business, financial
condition or results of operations.
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 $3,541,000
for the three months ended June 30, 2009. At June 30,
2009, our accumulated deficit amounted to $112,346,000. During the three months ended June 30,
2009, net cash used in operating activities amounted to $1,694,000. At June 30, 2009, our working
capital amounted to $1,430,000. 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.
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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.
Item 3. Default Upon Senior Securities
We did not default upon any senior securities during the quarter ended June 30, 2009.
Item 4. Submission of Matters to a Vote of the Security Holders
We did not submit any matters to a vote of security holders during the quarter ended June 30, 2009.
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. |
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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. | |
# | 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. |
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Date: August 7, 2009 | By: | /s/ Hojabr Alimi | ||
Hojabr Alimi | ||||
Its: Chairman of the Board of Directors and Chief Executive Officer (Principal Executive Officer) |
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Date: August 7, 2009 | By: | /s/ Robert Miller | ||
Robert Miller | ||||
Its: Chief Financial Officer (Principal Financial Officer) | ||||
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