SEC Comment Letter for InspireMD, Inc. (NSPR) (CIK 0001433607) (NSPR) — Sep 15, 2011
InspireMD, Inc. (NSPR) (CIK 0001433607)
Date: Sept. 15, 2011 · CIK: 0001433607 · Accession: 0000000000-11-055213
AI Filing Summary & Sentiment
File numbers found in text: 333-174948
Show Raw Text
September 15, 2011 Via E-mail Ofir Paz Chief Executive Officer InspireMD, Inc. 3 Menorat Hamaor St. Tel Aviv, Israel 67448 Re: InspireMD, Inc. Amendment No. 1 to Registrati on Statement on Form S-1 Filed August 26, 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 note that your disclosure of revenues in the opening paragraph should be balanced by disclosure of your net income or net loss for the completed fiscal year and stub period. Revise accordingly. 2. Revise the prospectus, where appropriate, to expand your discussion of the transactions related to the share exchange , including your transactions with former chief executive officer Lynn Briggs and your escrow arrangement. 3. We note your response to prior comment 2. Please provide marked pages from the journals and articles mentione d in the first and fifth paragr aphs of this section supporting your disclosure. Ofir Paz InspireMD, Inc. September 15, 2011 Page 2 4. Please clarify the reference in the sixth pa ragraph of this sec tion to “percutaneous coronary intervention.” 5. We note your response to prior comment 4, in cluding the final sentence of the third paragraph on page 2. However, your statem ent that one trademark (MGuard) refers to another (MGuard Prime) is not clear. Therefore, we reissu e the comment. With a view to disclosure, please tell us whether you will need to secure an additional CE mark for MGuard Prime. We expect to derive our revenues from sa les of our MGuard stent products, page 5 6. We note that in response to prior comment 5 you expanded the bullet points in this risk factor to include cross-references to other ri sk factor headings. This response does not address our request that you expand your disclosure of the bulleted risks or provide appropriate discussion of such risks under separate headings. Therefore, we reissue prior comment 5. We may have violated Israel i securities laws, page 14 7. We note your response to prior comment 8. Plea se expand this risk factor to disclose when you applied for a no-action determinati on, the status of your application and the fines and penalties that may be applicable. Management’s Discussion and Analysis, page 18 Results of Operations, page 20 Six Months Ended June 30, 2011 Compared to Six Months Ended June 30, 2010, page 23 8. Please refer to our prior comment 12. We note your revised disclosure that explains that deferred revenue decreased by approximately 80% and this was offset by an increase in gross revenues of 93%, however, your discussi on of the changes in deferred revenue to various distributors and the gross revenue to various di stributors does not provide investors with the underlying reasons for the changes in revenues between periods. In light of the significant recogni tion of revenues during the si x months period ended June 30, 2011 that were previously deferred, expl ain what events occurred during the six months period ended June 30, 2011 that resu lted in the recognition of the related revenues. In addition, provide insight as to the underlying reasons for the increases in gross revenues to your various distributors durin g the period. Furthermore, as previously requested, please discuss and quantify each fact or that caused the decrease in revenue between the six months ended June 30, 2011 and the six months ended June 30, 2010. Ofir Paz InspireMD, Inc. September 15, 2011 Page 3 Liquidity and Capital Resources, page 25 9. Please tell us where you have discussed your factoring arra ngement in this section. Our Industry, page 29 10. We note your response to prior comment 15. Please tell us how you confirmed that the market data presented on pages 29, 30 and 38 reflects the most recent available data. Also, please provide marked pages from the re ports mentioned in this section supporting your disclosure. Our Products, page 29 11. Please clarify the references to “myocardial blush grade” and “restenosis rates” in the second and third paragraphs on page 30, resp ectively. Also, clarify why the results of your clinical studies “suggest ” higher levels of MBG and lo wer rates of adverse cardiac events and why, if true, these findings would give you a competitive advantage. Product Development and Critical Milestones, page 31 Pre-Clinical Studies, page 31 12. We note that certain information related to FDA Approval, U.S. Sales, Start of Study and End of Study remained “To be determined” as of the date of the initial filing of the registration statement. We also note that in this amendment to the registration statement you have revised your disclosure to reflect that the same inform ation is “Not applicable.” With a view to disclosure, please explai n the bases for the changed disclosure. 13. We note your disclosure on pages 9 and 10 of your Form 8-K filed on April 6, 2011. However, your tabular disclosure in this sec tion appears to indicate that the start and end of the studies have been delayed. With a vi ew to disclosure, pleas e explain the reasons for the delays. Ongoing Clinical Trials, page 34 14. We note your response to prior comment 19 and reissue. With a view to disclosure, please provide the staff with a clear explan ation as to the differing results of your 2005 and 2006 studies. 15. We note that on page 34 you disclose the number of patients in your studies as of June 1, 2011. We also note that you have disclosed on page 36 your plan to launch a study in the second fiscal quarter of 2011. Please revise the prospectus to update your disclosure. Ofir Paz InspireMD, Inc. September 15, 2011 Page 4 Future Clinical Trials, page 36 16. We note your response to prior comments 16. We also note your revised disclosure under “Government Regulation” on page 41. Please reconcile your disclosure of the countries in which you will seek approval and provide a discussion of the necessary steps and timeline for approval in these countries , including applicable local requirements. 17. In this regard, it is unclear why you have elected not to discuss your plans for product approval in China given your disclosure in the prospectus that you are “aggressively pursuing additional registrations” in China as we ll as other countries. We also note your disclosure that you have filed fo r intellectual property protecti on in China. Please revise your prospectus accordingly. Manufacturing and Suppliers, page 42 18. We note your response to prior comments 17 and 24. Please expand your discussion of the material terms of your license agreement to include a description of term, termination and indemnification provisions, if any. To the extent there ar e additional material provisions, please describe. Al so, provide similarly expanded discussion of the material terms of the other manufacturing and supply agreements disclosed in this section. Selling Stockholders, page 51 19. We note your response to prior comment 27. Gi ven the nature of the transaction being registered, please advise the staff of the company’s basis for determining that the transaction is appropriately char acterized as a transaction that is eligible to be made on a shelf basis under Rule 415(a)(1)(i). Financial Statements for the Years Ended December 31, 2010 and 2009 Note 2 – Significant Accounting Policies, page F-8 l. Revenue Recognition, page F-10 20. We note from your response to our prior co mment 33 that you provide free products as incentives to certain distribut ors but see you indicate you wi ll provide disclosures of credits, rebates, price protection and other similar incentives if relevant. We also note from the Addendum to the Distribution Agr eement with Hand-Prod (filed as exhibit 10.28) that it appears that you offer this distri butor free stents as indicated in the tabular summary. Please explain if th ese incentives are material an d explain your response that you will disclose if relevant. 21. In this regard, we note from the tabular su mmary provided as part of the Addendum to the Distribution Agreement that the stents will be placed in a special warehouse and Ofir Paz InspireMD, Inc. September 15, 2011 Page 5 shipped when the order to send the stents is received. Please tell us more about the storage and delivery process and specify at which point you rec ognize revenue for the stents. Please refer to the applicable guid ance in SAB 104 as part of your response. 22. Additionally, we note from the tabular summar y provided as part of the Addendum to the Distribution Agreement that Hand Prod will pre pa y for orders or pay after the invoice is received. Please tell us if these payments are for multiple deliverables or are only for the stents. Note 8 – Long-Term Loan, page F-17 23. Please refer to our prior comment 37. While we see your disclosure that the bank asked you to grant additional fixed liens in N ovember 2010, we do not see where you explain the underlying reason for that request. As previously requeste d, please revise your disclosure accordingly. Note 10 – Commitments and Con tingent Liabilities, page F-20 c. Litigation, page F-21 24. Please refer to our prior comment 38. While we note your revised disclosure in 10.c. 1) and other similar subsequent listings in this litigation disclosure se ction that you have not recorded an expense related to damages becau se management is of the opinion that a loss is neither probable nor estimable, in our pr ior comment we specifically referred to the disclosure requirements rega rding a reasonably possible loss or range of loss. For each claim that no accrual is made for loss continge ncy or an exposure to loss exists in excess of the amount accrued, please expl ain to us if there is at leas t a reasonable possibility that a loss or an additional loss may have b een incurred and your reasons for such conclusion. Please note that for unrecognized contingencies associated to each claim listed on page F-21 and F-46 that meet th e criteria in paragra ph 3 of ASC 450-20-50 you are required to disclose (i) the nature of the contingency, and (ii) the possible loss or range of loss or provide a statement that su ch an estimate cannot be made. Please revise your disclosure accordingly. 25. Please refer to our prior comment 39. Pleas e further explain why you allocated the $134,000 expense to the year ended December 31, 2006 when the claim was submitted in November 2010. In this regard, please tell us how much of the total expense was recorded in 2005 and 2006, and explain why you be lieve it is appropriate to adjust prior financial statements to record this expens e when the claim was submitted in November 2010. Please provide a similar explanation as it relates to Note 10 c. 6. We also noted that your revised disclosures in c.5) and c.6) eliminated the date the claim was filed, i.e. November 2010. Please explain your rationale fo r this revision. We will continue to review your response to our prior comme nt 39 upon receipt of the aforementioned information. Ofir Paz InspireMD, Inc. September 15, 2011 Page 6 26. We note from your response to our prior comme nt 39 that the fair value of the stock options with respect to the litigation described in Note 10c.4 was $2.5 million using the Black-Scholes valuation model, as of May 2009, which was the period for which the claimant claims these stock options. In this regard, please ex plain to us how you accounted for these stock options at the in itial recognition of this claim and your accounting or planned accounting between the initial recognition of this claim and the date that the actual stock op tions are granted. Please provide references to the authoritative literature, which supports your accounting. Additionally, please clarify for us if any of the stock options have been granted, providing as part of your response the grant dates and number of stock options. Pleas e provide a similar expl anation as it relates to the stock options discussed in Note 10c.3 and 10c.5. 27. Please refer to our prior comment 40. It appe ars you have revised this disclosure to change the $1,020 thousands in cl aims to $20,000. Please explain. 28. We note that you have recorded provisions relating to claims made against you based upon the opinion of your legal counsel. We al so see that you have not recorded an expense related to damages in connecti on with certain other matters because management, after consultation with legal couns el, is of the opini on that the ultimate resolution of these claims will not result in a loss to the Company. Please refer to Question 233.02 of the Compliance and Disclo sure Interpretations on Securities Act Rules, which can be found at http://www.sec.gov/divisions/corpfin/guida nce/securitiesactrule s-interps.htm and describe to us and revise this note to clar ify the nature and extent of your reliance on legal counsel in determining whether a liabil ity was required and the amount of each of the provisions you recorded. In particular, please differentiate be tween those instances where you relied exclusively on the opinion of legal counsel to provide you the amount of the required liability versus the instances where the opinion of legal counsel was one of other factors considered by mana gement in reaching its conclusion. Note 13 – Supplementary Financial Statement Information, page F-30 f. Financial expenses (income), net, page F-31 29. Please refer to our prior comment 41. We note from your disclosure in footnote 7 that your initial valuation of th e beneficial conversion feature was $308,000. Please further explain in your disclosure how you determined that the intrin sic value of the beneficial conversion feature at the time of extinguishme nt was equal to the original beneficial conversion feature in the amount of $308,000. Additionally, tell us whether you made any prior payments on the loan, and how you included this as part of your analysis. 30. In this regard, based on the guidance of FA SB ASC 470-20-40-3, it appears that any gain recognized should be recorded as a gain or lo ss on extinguishment of the convertible debt security. Please revise y our disclosures accordingly. Ofir Paz InspireMD, Inc. September 15, 2011 Page 7 We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing incl udes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disc losure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request accelera tion of the effective date of the pending registration statement please pr ovide a written statement from the company acknowledging that: should the Commission or the staff, acting pursua nt to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not re lieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing;