SEC Comment Letter for PTC THERAPEUTICS, INC. (PTCT) (CIK 0001070081) (PTCT) — Dec 15, 2015
PTC THERAPEUTICS, INC. (PTCT) (CIK 0001070081)
Date: Dec. 15, 2015 · CIK: 0001070081 · Accession: 0000000000-15-057911
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File numbers found in text: 001-35969
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Mail Stop 4720 December 15, 2015 Via E -mail Mr. Shane Kovacs Chief Financial Officer PTC Therapeutics, Inc. 100 Corporate Court South Plainfield, New Jersey 07080 Re: PTC Therapeutics, Inc. Form 10-K for the Fiscal Year Ended December 31, 201 4 Filed March 2 , 2015 Form 10 -Q for the Quarterly Period Ended September 30, 2015 Filed November 9, 2015 File No. 001-35969 Dear Mr. Kovacs : We have limited our review of your filings to the financial statements and related disclosures and have the following comments . In our comment s, we ask you to provide us with information so we may better understand your disclosure. Please respond to th ese comment s within 10 busine ss days by providing the requested information or advis e us as soon as possible when you will respond . If you do not believe that a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to t hese comments , we may have additional comments. Form 10 -K for the Fiscal Year Ended December 31, 201 4 Item 6. Selected Financial Data, page 94 1. You present only three years of statements of operations data in your table. As information for 2011 was presented in your initial public offering registration statement on Form S -1, File Number 333 -193677, please represent to us that you will include fiv e years of information in your 2015 Form 10 -K as required by Item 301(a) of Regulation S - K. In addition, please represent that you will include the balance sheet information required by Instruction 2 to Item 301 of Regulation S -K in your 2015 Form 10 -K. Mr. Shane Kovacs PTC Therapeutics, Inc. Dece mber 15, 201 5 Page 2 Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical accounting policies and significant judgments and estimates Inventories and Cost of Product Revenues, page 100 2. Please tell us why you have not capitalized a ny inventory costs for Translarna product manufactured for sale in Europe under your conditional approval and reference for us the authoritative literature you relied upon to support your accounting. Please ensure your response also addresses the followin g: Tell us the amount of inventory costs you charged to expense in each fiscal year. Tell us the amount of inventory costs you charged to expense prior to receipt of conditional approval. Tell us why it is appropriate to charge inventory costs incurred aft er receipt of conditional approval to research and development expenses. Explain to us how the ultimate commercial sale of this product meets the definition of research or development under ASC 730 -10-20 by discovering new knowledge or translating that knowledge into new products, processes or techniques. Tell us the amount of royalties and other miscellaneous selling costs, as indicated on page 10 of your September 30, 2015 Form 10 -Q, associated with your product sales that you have charged to research and development costs. Explain to us how these costs meet the definition of research or development . Tell us the amount of zero -cost inventory you have on hand in terms of units, the number of units you have sold by reporting period through September 30, 2015 and why you do not provide any indication of the amount of this inventory on hand in your filings. Although you characterize the amount of cost of sales in 2014 as being insignificant, tell us what the cost of sales for 2014 and each quarter in 2015 would have been if you had not charged all your inventory costs to research and development expenses. Tell us your consideration for disclosing these amounts and why it is apparently not meaningful information for investors to understand the potential gro ss margins for Translarna. Form 10 -Q for the Quarterly Period Ended September 30, 2015 Notes to Consolidated Financial Statements Note 2: Summary of significant accounting policies Revenue Recognition Net Product Sales, page 11 3. Please tell us whether you grant the right of return to your Translarna customers. If so, please tell us the provisions of your return policy and demonstrate to us how you were able to make reasonable estimates of returns as required by ASC 605 -15-25-1f in order to record revenue upon product shipment effective January 1, 2015. In this regard, you disclose on page 4 of your 2014 Form 10 -K that Translarna is the first ever approved Mr. Shane Kovacs PTC Therapeutics, Inc. Dece mber 15, 201 5 Page 3 treatment for the underlying cause of nonsense mutation Duchenne muscular d ystrophy and that you did not launch Translarna on a commercial basis until December 2014. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing s to be certain that the filing s include all information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures th ey have made. In responding t o our commen ts, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing s; staff comment s or changes to disclosu re in response to staff comment s do not foreclose the Commission from taking any action with respect to the filing s; and the compa ny may not assert the staff comment s as a defense in any proceeding initiated by the Commission or any person under the federal secu rities laws of the United States. You may contact Mark Bru nhofer, Senior Staff Accountant, at (202) 551 -3638 or Sharon Blume, Accounting Branch Chief, at (202) 551 -3474 if you have questions regarding the comment s. In this regard, do not hesitate to contact me at (202) 551 -3679 . Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant Office of Healthcare and Insurance