SEC Comment Letter for Sonoma Pharmaceuticals, Inc. (SNOA) (CIK 0001367083) (SNOA) — Jul 28, 2006
Sonoma Pharmaceuticals, Inc. (SNOA) (CIK 0001367083)
Date: July 28, 2006 · CIK: 0001367083 · Accession: 0000000000-06-035553
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File numbers found in text: 333-135584
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Mail Stop 6010 July 28, 2006 Hojabr Alimi Chief Executive Officer and President Oculus Innovative Sciences, Inc. 1129 N. McDowell Blvd. Petaluma, California 94954 Re: Oculus Innovative Sciences, Inc. Registration Statement on Form S-1 Filed July 3, 2006 File No. 333-135584 Dear Mr. Alimi: We have reviewed your registration stat ement and have the following comments. Where indicated, we think you should revise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Pl ease be as detailed as necessary in your explanation. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. After reviewing this information, we may raise additional comments. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. General 1. Please confirm that any preliminary prosp ectus you circulate will include all non- Rule 430A information. This includes the price range and related information based on a bona fide estimate of the public offering w ithin that range. Also, in the next amendment, please fill in the blanks throughout the filing, and note that we may have additional comments after you do so. 2. Please provide us with copies of any gra phics or artwork that you intend to use in your prospectus. We may have further co mment after reviewing those materials. Hojabr Alimi Oculus Innovative Sciences, Inc. July 28, 2006 Page 2 3. We note that on your website you referen ce distribution of your products in Iran, Sudan, and Syria, countries identified by the U.S. State Department as state sponsors of terrorism, and subject to U.S. economic sanctions. Please describe for us the extent and nature of your past, cu rrent, and anticipated contacts with those countries, whether through subsidiaries, dist ributors, affiliates or other direct or indirect arrangements. Discuss sales or other contacts with the governments of these countries, including government-own ed or controlled entities, and private parties. Please also describe any po tential or actual military uses of your products, other than wound care. 4. Discuss for us the materiality to you of your contacts with Iran, Sudan, and Syria, individually and in the aggr egate, and whether those cont acts, individually or in the aggregate, constitute a material investment risk for your security holders. Please address materiality in quantitative terms, including the dollar amounts of any associated assets and liabilities, and revenues. Please also address materiality in terms of qualitative fact ors that a reasonable investor would deem important in making an investment decision, including the potential impact of corporate activities upon a company’s re putation and share value. We note, for example, that Arizona and Louisiana have adopted legislation that requires their state retirement systems to prepare reports rega rding state pension fund assets invested in, and/or permits divestment of state pension fund assets from, companies that do business with U.S.-designated state sponsors of terrorism. The Pennsylvania legislature has adopted a resolution directing its Legislative Budget and Finance Committee to report annually to the General Assembly regarding state funds invested in companies that have ties to terrorist- sponsoring countries. The Missouri Invest ment Trust has established an equity fund for the investment of certain state-he ld monies that screens out stocks of companies that do business with U.S.-des ignated state sponsor s of terrorism. Illinois, Maine, New Jersey and Ore gon have adopted legislation requiring reporting of interests in, or divestment from, companies that do business with Sudan, and similar legislation has been pr oposed by several other states. Finally, Harvard University, Yale University, Stan ford University, and other educational institutions have adopted policies prohi biting investment in, and/or requiring divestment from, companies that do bus iness with Sudan. Your materiality analysis should address the potential imp act of the investor sentiment evidenced by such actions directed toward companies that operate in Iran, Sudan, and Syria. Hojabr Alimi Oculus Innovative Sciences, Inc. July 28, 2006 Page 3 Prospectus Summary, page 1 Oculus Innovative Sciences, Inc., page 1 5. Please clarify your disclosure in the final two paragraphs of this section so that potential investors can more readily identify the products you are currently marketing, those for which you are seeking or plan to seek regulatory approval, and the geographic markets for each. Cons ider presenting this information in bullet point or tabular format. 6. Please tell us whether all of the sources of the data cited in the prospectus have consented to your use of their data an d whether any reports were prepared specifically for your use. 7. Please revise the “Principal Risks” s ubsection of your summary to present the information disclosed using bullet points, subcaptions or another more readable format. The Offering, page 4 8. Please expand your disclosure to address the treatment of shares reserved for future grants under your 2006 stock incentive plan. Summary Consolidated Fi nancial Data, page 5 9. Please revise the table in footnote (1) on page 5 and footnote (1) on page 30 to remove the caption which currently shows the totals of the stock-based compensation expense amounts presented in the individual inco me statement line items. We refer you to Section I.C.2 of the 12/1/05 Current Accounting and Disclosures Issues in the Division of Co rporation Finance, which can be accessed at http://www.sec.gov/divisi ons/corpfin/acctdis120105.pdf . Risk Factors, page 7 10. If true, please add a risk factor that addresses the fact th at your Articles of Incorporation will authorize the issu ance of 100,000,000 shares of common stock and 5,000,000 shares of preferred stock, that authorized but unissued shares may be issued without further shareholder approval and that these shares may be granted rights and preferences that are greater than t hose of common shares being offered pursuant to this prospectus. Hojabr Alimi Oculus Innovative Sciences, Inc. July 28, 2006 Page 4 We may incur significant li abilities . . ., page 9 11. Please disclose whether you are aware of th e Mexican Ministry of Health’s intent to pursue claims against you. Also disclose the statute of limitations, if any, that would limit the MOH’s ability to bring claims in the future. 12. Please revise the MD&A to discuss your relationship with MOH. We note the first and last sentences of this risk factor. We are in a dispute with the licensor …, page 12 13. Please disclose the material amount of your revenues from the patent license. Also, clarify whether the loss of the pa tent licenses may affect sales of your products outside of Japan. In addition, file the agreement as an exhibit. Capitalization, page 25 14. Please revise to remove the caption rela ting to cash and cash equivalents from your presentation of capitalization. Management’s Discussion and Analysis . . ., page 31 15. We note your discussion of the need to perform clinical trials on your Microcyn platform technology and your disclosure on pa ge 3 that clinical trials will be “lengthy and expensive.” We furthe r note your reference on page 18 to development of a compound with potentia l applications in oncology. Provide more details of the specific plans to pursue commercialization of the your products and product candidates, quantify the estimated costs and discuss the expected funding/ financing sources. You should also discuss the expected timing of these events. Discontinued Operations, page 33 16. Please file as exhibits the agreements with Quimica Pasteur. Comparison of Years Ended March 31, 2006 and March 31, 2005, page 36 Cost of Revenues, pages 36 and 38 17. Please revise to discuss the specific r easons for the significant gross loss each period and your plans and efforts to generate gross profit from your products and services. In addition, discuss the expected impact to Oculus Innovative Sciences if you are not able to do this. Hojabr Alimi Oculus Innovative Sciences, Inc. July 28, 2006 Page 5 Liquidity and Capital Resources, page 39 18. Please tell us how you will account for the warrants issued in connection with the Loan and Security Agreement entered into in June 2006. Business, page 44 19. Please file the consents required by Rule 436 for the physician clinical studies summarized in your prospectus. Overview, page 44 20. Please revise the first paragraph here a nd in the summary to clarify that you do not have the necessary regulatory approva ls to market Microcyn in the United States as a drug. Our Products – Microcyn Platform, page 49 21. Please clarify how each of the products listed in the table differ. We note, for example, the varying indications for “Dermacyn Wound Care” in the United States, European Union and Canada. Are these different products? Also, please reconcile your product indicat ion descriptions here with your disclosure on page 3, which implies that the United States and European Union versions of Dermacyn are identical to one another and to Microyn60 in Mexico. 22. Please explain technical terms, such as “stasis ulcers.” Clinical Trials and Physician Studies, page 51 Completed Trials and Studies, page 51 23. Please specify which of the studies you sponsored and disclose the details of your sponsorship, quantifying the extent of your sponsorship if possible. 24. Revise your disclosure to identify Dr. Luca Dalla Paola as a member of your business and medical advisory board. 25. Tell us how you selected the physician c linical studies to highlight in your prospectus and provide us with details regarding the seven additional studies not summarized in the prospectus. Hojabr Alimi Oculus Innovative Sciences, Inc. July 28, 2006 Page 6 Sales and Marketing, page 54 26. Please file all material agreements re quired by Item 601(b) of Regulation S-K, including any material di stribution agreement. 27. Please revise the last paragraph of this section to specify th e regulatory approvals needed and disclose the steps you have taken to receive those approvals. Other Market Opportunities, page 55 28. Please disclose the amount of material revenues from each of the other market opportunities, such as the percentage of revenues from veterinary medicine. 29. Please expand the second paragraph on page 55 to identify the leading manufacturer. Also, file th e agreement as an exhibit. 30. Please expand the third full paragraph on page 56 to specify the regulatory approvals needed. Research and Development, page 56 31. Please expand your disclosure to explain what your “L3 anti-viral compound” is and to provide details of the referenced pr eclinical studies. Please reconcile your development of this compound with your statement in the first sentence of this section regarding the goals of your re search and development program. Intellectual Property, page 57 32. Please clarify the signifi cance of having (i) filed pr ovisional, as opposed to non- provisional, patent applications and (ii) received a no tice of allowance from the U.S. Patent and Trademark Office. Foreign Regulation, page 65 33. Please disclose in greater detail the gove rnment regulatory approval processes for those jurisdictions in which you manufact ure, market or sell your products, including, for example, Mexico. Executive Officers, Key Employees and Directors, page 67 34. Please discuss the business experience during the past five years of Mr. Alimi. Hojabr Alimi Oculus Innovative Sciences, Inc. July 28, 2006 Page 7 Employment, Severance and Change of Control Arrangements, page 74 35. Please tell us how you will account for the additional options that will be granted upon completion of the offering discussed on page 74. Equity Compensation Plans, page 75 36. Please summarize the material terms of your 2006 Stock Incentive Plan. Physician Advisors, page 79 37. Please clarify how you compensate your clinical investigational board. 38. Please clarify the role of the business and medical advisory board and the clinical investigational board by in cluding specific information regarding their activities for your company. 39. Please tell us whether the physicians disclo sed in this section have consented to the description of their role with you. Related Party Transactions, page 81 40. Please disclose the payments to date to White Moon Medical. 41. Please clarify why all options held by your directors will vest upon completion of this offering. For example, was this a term of their original option agreements or plan? Change in Independent Registered Public Accounting Firm, page 93 42. Please revise to provide all disclosure s required by Item 304 of Regulation S-K and the Exhibit 16 letter from PricewaterhouseCoopers. Financial Statements, page F-1 43. Please update the financial statements as required by Rule 3-12 of Regulation S- X. 44. Include updated accountants’ consents with all amendments to the filing. Hojabr Alimi Oculus Innovative Sciences, Inc. July 28, 2006 Page 8 Consolidated Statements of Cash Flows, page F-7 45. We note that the effect of exchange rates on cash of $144, $(127), and $(14) for fiscal 2006, 2005 and 2004, respectively, are the same as the foreign currency translations on your consolidated statements of stockholders’ equity (deficit). Please tell us whether you prepared the statement of cash flows for your foreign operations using the exchange rates in e ffect at the time of the cash flows in accordance with paragraph 25 of SF AS 95. Revise as necessary. Note 3 – Summary of Significant Accounting Policies, page F-8 Accounts Receivable, page F-10 46. Please clarify the nature of the govern ment charge-backs and how these are recorded in your financial statements. Note 8 – Accrued Expenses and Other Current Liabilities, page F-19 47. Please tell us the nature of the accrual for stock option rescission. Note 9 – Long-Term Debt, page F-19 48. We note that you allocated a portion of the proceeds from your debt financings to warrants. Please revise to disclose the significant assumptions used to value the warrants. Note 12 – Stockholders’ Equity, page F-24 Valuation of Common Stock, page F-27 49. Provide us with an itemized chronologi cal schedule detailing each issuance of your preferred shares, ordinary shares, st ock options and warrants during the last 12 months. Include the following information for each issuance or grant date: a. Number of shares issued or issuable in the grant b. Purchase price or exercise price per share c. Any restriction or vesting terms d. Management’s fair value per share estimate e. How management determined the fair value estimate f. Identity of the recipient a nd relationship to the company g. Nature and terms of any concurrent transactions with the recipient h. Amount of any recorded compensation element and accounting literature relied upon Hojabr Alimi Oculus Innovative Sciences, Inc. July 28, 2006 Page 9 In the analysis requested a bove, highlight any transacti ons with unrelated parties believed by management to be particularly evident of an objective fair value per share determination. Progressively bri dge management’s fair value per share determinations to the current estimated IPO price per share, identifying all material po