SEC Comment Letter for InspireMD, Inc. (NSPR) (CIK 0001433607) (NSPR) — Jul 13, 2011
InspireMD, Inc. (NSPR) (CIK 0001433607)
Date: July 13, 2011 · CIK: 0001433607 · Accession: 0000000000-11-042497
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File numbers found in text: 333-174948
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July 13, 2011 Via E-mail Ofir Paz Chief Executive Officer InspireMD, Inc. 3 Menorat Hamaor St. Tel Aviv, Israel 67448 Re: InspireMD, Inc. Registration Statement on Form S-1 Filed June 16, 2011 File No. 333-174948 Dear Mr. Paz: We have reviewed your registration statem ent and have the following comments. In some of our comments, we may ask you to provi de us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your re gistration statement and the information you provide in response to these comments , we may have additional comments. Overview, page 1 1. Please revise the opening paragraph to disclo se your revenues for the most recently completed fiscal year and stub period, as applicable. 2. Please provide objective support fo r your statement in the final paragraph of this section that cobalt-chromium stents are “generally known in the i ndustry to provide better deliverability and possibly even a reduc tion in major adverse cardiac events.” 3. We note that this section fo cuses extensively on the streng ths of your product. Please revise the Summary and Business sections to add balancing disclo sure addressing any drawbacks or competitive disadvantages facing your products. Ofir Paz InspireMD, Inc. July 13, 2011 Page 2 4. We note in the second-to-last pa ragraph of this section that your current CE mark covers your first generation product, MGuard Coronar y. With a view to disclosure, please tell us whether the MGuard Prime will require you to secure an additional CE Mark. We expect to derive our revenue from sa les of our MGuard stent products, page 4 5. If the bulleted risks listed in the second paragraph are materi al, please expand your disclosure of the risks under this heading or provide appropriate di scussion of the risks under separate risk factor headings. Clinical trials necessary to support a pre-market approval application, page 6 6. Please revise to clarify whet her the Cypher and Taxus Expre ss2 stents are your products. If we fail to maintain or establish sati sfactory agreements w ith suppliers, page 10 7. Please confirm that you have filed all materi al agreements with QualiMed Innovative Medizinprodukte GmbH, MeKo Laserstrahl-Ma terialbearbeitung and Natec Medical Ltd. We may have violated Israel i securities law, page 13 8. With a view to disclosure, please tell us when you applied for a no-action determination from the Israel Security Authority. In your re sponse, please also provide the staff with an update of the current status of your request a nd describe the fines and other penalties to which you may be subject. Because we became public by means of a “reverse merger”.., page 14 9. Please expand this risk factor to further disc uss the risk presented. For instance, clarify the meaning of your statement that brokerage firms have “no incentive”’ to cover your common stock. Use of Proceeds, page 17 10. Revise the second paragraph to quantif y the maximum amount of proceeds you may expect to receive if the warrants are exercised on a cash basis. Ofir Paz InspireMD, Inc. July 13, 2011 Page 3 Management’s Discussion and Analysis of Financ ial Condition and Results of Operations, page 18 Critical Accounting Policies, page 18 Inventory, page 19 11. Please revise to include your policy regarding your review for obsolescence and the way in which you write inventory down to market value. Results of Operations, page 20 Three Months Ended March 31, 2011 Compared to Three Months Ended March 31, 2010, page 20 12. We note that your revenues have decreased by approximately 20% and noted from your disclosure that the decrease is primarily related to the rec ognition of previously recorded deferred revenues in the fi rst quarter of 2010 for which there was no comparable revenues in 2011, which appears to be more of a timing issue rather than an explanation of the underlying reason for the d ecrease in sales. In light of the significant decrease in revenues your MD&A disclosure does not appear to provid e investors with a thorough analysis that provides reader s a view of the company through the eyes of management. When individual line items, disclosed in your statements of operations, significantly fluctuate in comparison to the comparable prior period, please quan tify, and disclose the nature of each item that caused the significan t change. For example, please quantify each material factor, i.e. such as price changes and / or volume changes by type of product, disclose separately the effect on operations attributable to each factor causing the aggregate change from year to year and disclo se the nature of or reason for each factor causing the aggregate change. The analysis s hould reveal underlyi ng material causes of the factors described and any future impact on operating results. Please incorporate the above comment to all of the disclosures in th e analysis of your results of operations in MD&A, including operating expenses. For furt her guidance, please refer to Item 303 and the related instructions in Regulations S-K as well as SEC Interpretive Release No. 33- 8350. 13. In this regard, we also noted that desp ite the decrease in sales your gross margin percentage increased more than 10 percenta ge points, from 36.2% to 46.7%. Please revise to explain how you were able to obtain significant in creases in your gross margins and more efficient manufacturing and economies of scale when sales levels had actually decreased. Please quantify the increase in aver age selling prices and the number of units purchased as part of your disclosure and explain how the increased purchasing volumes you refer to relate to the overall decrease in sales during the period. Ofir Paz InspireMD, Inc. July 13, 2011 Page 4 14. Where changes in financial statement line items are the result of several factors, each significant factor should be separately quantified and discussed. For example, you say that the increase in general and administrative expense was primarily due to an increase in investor related activities and provisi ons for pending litigation. However, you do not quantify the impact of each of th ese factors. Please revise yo ur disclosure to address our concerns. Business, page 24 15. Regarding the market data that you disc lose in this sec tion, please tell us: how you confirmed that the data used in th e registration statement reflects the most recent available information; whether all of the data is publicly available; whether you paid for the comp ilation of any of the data; whether any of the data was prepared for your use in the registration statement; and whether the authors of the data consented to your use of such data in the registration statement. If you are affiliated with the preparation of any of the da ta, please ensure that your disclosure clearly indicates the nature of all such affiliations. 16. We note your discussion of pre-cl inical and clinical studies. However, this information is not presented within th e context of your curr ent and planned operations. With a view to disclosure, please provide a detailed discussion the necessary steps and associated costs required in order to receive approval to sell your products in the United States, China and other new markets into which you currently in tend to expand. Please provide the staff with a discussion of the number, size and complexity of the trials that must be completed as well as the expected timeframe for completion. 17. Please tell us where you have discussed th e terms and significance of the company’s license agreement to use the MGuard Prime stent design. Our Products, page 26 18. Please revise to further explain how your products differ from, and improve upon, existing products in the marketplace. Fo r example, your references to MGuard Coronary’s “enhanced clinical profile” and “enhanced bio-absorbability” and MGuard Carotid’s “superior embolic protection characteristics” are overly vague. Revise accordingly. Ofir Paz InspireMD, Inc. July 13, 2011 Page 5 Comparison of Clini cal Trials, page 31 19. We note the difference between the results of your 2005 and 2006 studies and the results of the trials described in this section. With a view to disc losure, please tell us whether your product underwent design changes or othe rwise explain the basis for the differing results. Product Positioning, page 34 20. Please quantify the market penetration describe d in the first paragraph of this section. Government Regulation, page 35 21. Please expand this section to disclose the material regulatory requirements for the international markets th at you are targeting. Customers, page 36 22. Please clarify whether you have a written agreement with Hand-Prod Sp. Z.o.o. and file such agreement as an exhibit. Also, disc uss the material terms of the agreement. Manufacturing and Suppliers, page 36 23. Please discuss the availability of raw materials. 24. Please expand your discussion of the materi al terms of your agreements with the companies mentioned in this section, in cluding any provision s related to term, termination, exclusivity or incen tive programs. Provide similar disclosure of the material terms of your distribution agreements. Executive Officers and Directors, page 38 25. For each director, please discuss clearly the sp ecific experience, qualifications, attributes or skills that lead to the conclusion that the person shoul d serve as a director for the registrant at this time in light of the registrant’s business and structure. 26. Please tell us why you do not discuss in th is filing your Scientific Advisory Board mentioned in exhibit 99.1 of your Form 8-K filed on April 6, 2011. Ofir Paz InspireMD, Inc. July 13, 2011 Page 6 Selling Stockholders, page 43 27. Please tell us whether any of the selling stoc kholders are broker-deale rs or affiliates of a broker-dealer. Any selling stockholder who is a broker-dealer must be identified in the prospectus as an underwriter. In addition, each selling stockholder who is an affiliate of a broker-dealer must be identified in the prospectus as an underwriter unless that selling stockholder is able to make the followi ng representations in the prospectus: The selling stockholder purchased the shares being registered for resale in the ordinary course of business. At the time of the purchase, the se lling stockholder had no agreements or understandings, directly or i ndirectly, with any person to distribute th e securities. Please revise as appropriate. 28. Please disclose the natural person or persons who have voting and/ or investment power for the shares held by the selling stockholders. Financial Statements for the Years Ended December 31, 2010 and 2009 29. Consideration should be given on an ongoing ba sis to the updating re quirements of Rule 8-08 of Regulation S-X. An updated accountant’s consent should also be included with any amendment to the filing Report of Independent Registered Public Accounting Firm, page F-2 30. It does not appear that your auditors’ report incl udes the appropriate electronic signature form. Please ask your auditors to provide a revised report with the appropriate electronic signature in your next amendment. Note 2 – Significant Accounting Policies, page F-8 l. Revenue Recognition, page F-10 31. We note your disclosure that when returns canno t be reliably estimated both revenues and related direct costs are eliminated, and the products are deemed unsold, you defer revenues and indicate the inve ntory as held on consignment as part of your financial statements. Please tell us why you refer to sales of items where the returns cannot be estimated to be inventory on consignment. Also explain your classification and cite the accounting guidance upon which you based your accounting. 32. In this regard, please revise to more fully explain your return policy, including the term of the return period. Additionally, please explain to us why you record your provision for Ofir Paz InspireMD, Inc. July 13, 2011 Page 7 sale returns and related costs as “account s payable and accruals” and “inventory on consignment”, respectively. Also, tell us wh en you realize the related deferred revenues. Please quantify the aforementioned amounts as part of your response for each period presented. 33. Please expand your disclosure to describe your revenue recognition policy in greater detail. To the extent that the policy differs among customer categories, please make your disclosure product line specific. Details shou ld be provided to the extent that policy differs among the various marketing venues us ed by the Company, i.e. distributors and direct sales. Also, if the po licies vary in different parts of the world, those differences should be discussed. Provide details of di scounts, post shipment obligations, customer acceptance, warranties, credits, rebates, a nd price protection or similar privileges and how these impact revenue recognition. n. Share-Based Comp ensation, page F-11 34. We noted your disclosure that you elected to recognize compensation expense for awards with only service conditions that have grad ed vesting schedules using the accelerated multiple option approach. With regards to what you refer to as your election, please clarify for us if you have awards other than those with service conditions and tell us how you determine and recognize related compensation expense. v. Factoring of Receivables, page F-13 35. We note your disclosures that you factored cert ain of your trade rece ivables. Please tell us the amounts factored and explain whet her you have any ongoing obligations or recourse related to those factored receivables. Note 8 – Long-Term Loan, page F-17 36. We note your disclosure that the first loan totaled $750 thousand, you did not receive the second loan, and the credit line was not utilize d. Please tell us the ba lance due on the loan as of December 31, 2009 and 2010 and how you have included those liabilities on the balance sheet for each period. 37. Revise to explain why you were required to grant additional fixed liens in November 2010 and again at December 31, 2010. Note 10 – Commitments and Con tingent Liabilities, page F-20 c. Litigation, page F-21 38. We see you indicate herein that you are involv ed as defendants in va rious litigations. For those claims that no accrual is made for loss contingency or if an exposure to loss exists Ofir Paz InspireMD, Inc. July 13, 2011 Page 8 in excess of the amount accrued, please revise to explain if there is at least a reasonable possibility that a loss or an additional loss may have been incurred and your reasons for such conclusion. Please note that for unrecogniz ed contingencies that meet the criteria in paragraph 3 of ASC 450-20-50 you are required to disclosure (i) the nature of the contingency, and (ii) the possibl e loss or range of loss or provide a statement that such an estimate cannot be made. Please revise your disc losure to provide the required disclosure, if applicable. 39. Reference is made to the litigation describe d in Note 10 c. 4 and 5. Please revise to disclose the fair value of the stock op tions in both claims, and the method and assumptions used to estimate such fair value. Additionally, clarify for use the period in which you recorded the provisions associated to each claim. As part of your response, please explain why you would record the $20,000 provision as described in Note 10 c. 4 in 2009 when the claim was submitted in Nove mber 2010. Additionall