SEC Comment Letter for VERTEX PHARMACEUTICALS (VRTX) — Jun 27, 2012
VERTEX PHARMACEUTICALS INC / MA (VRTX) (CIK 0000875320)
Date: June 27, 2012 · CIK: 0000875320 · Accession: 0000000000-12-033558
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File numbers found in text: 000-19319
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June 26, 2012 Via E -mail Ian F. Smith Executive V ice President , And Chief Financial Officer Vertex Pharmaceuticals I ncorporated 130 Waverly Street Cambridge, Massachusetts 02139 Re: Vertex Pharmaceuticals Incorporated Form 10-K for the Fiscal Year Ended December 31 , 201 1 Filed February 22, 201 2 Form 10 -Q for the Quarterly Period Ended March 31, 2012 Filed May 10, 2012 Form 8 -K dated April 26, 2012 Filed April 26, 2012 Form 8 -K dated February 2, 2012 Filed February 2, 2012 File No. 000-19319 Dear Mr. Smith: We have limited our review to only your financial statements and related disclosures and do not intend to expand our review to other portions of your document . In our comment s, we ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe a comment appl ies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your response s to our comment s. After reviewing the informati on provided, we may have additional comments and/or request that you amend your filing s. Form 8 -K filed February 2, 2012 and Form 8 -K filed April 26, 2012 Exhibit 99.1 1. In these exhibits you present entire statements of operations to reconcile your GAAP earnings to non -GAAP earnings. Please represent to us that you will no longer present these tables in future Item 2.02 Form s 8-K or elsewhere. Please see Question 102.10 of our Compliance & Disclosure Interpretations for Non -GAAP Financial Measures 5 Ian F. Smith Executive Vice President , And Chief Financial Officer Vertex Pharmaceuticals Incorporated June 26, 2012 Page 2 (http://www.sec.gov/divisions/corpfin/guidance/nongaapinterp.htm ). Please also see Instruction 2 to Item 2.02 of Form 8 -K which indicates that the provisions of Item 10(e)(1)(i) app ly to these public disclosures. Form 10 -K for the Fiscal Year Ended December 31, 201 1 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations Results Of Operations Operating Costs and Expenses Cost of product revenues, page 63 2. You state herein t hat you expensed most of the manufacturing costs of INCIVEK sold in 2011 as research and development expenses in periods prior to January 1, 2011 and expect your cost of INCIVEK to increase as a percentage of net sales in future periods. In your Form 10 -Q for the quarterly period ended March 31, 2012, you indicate that you expensed most of the manufacturing costs of INCIVEK and KALYDECO sold in the first quarter as research and development expenses in prior periods and expect your cost of revenues to increase as a percentage of net sales in future periods. Please tell us the nature and amount of the manufacturing costs that you expensed as research and development expenses for each of the following periods: prior to Jan uary 1, 2011 ; the year ended December 31, 2011; and the quarter ended March 31, 2012. Reconcile these amounts to the “drug supply cost” in comment 4 below and for any differences, provide us your analysis supporting classification as research and develop ment expense . Also , for the year ended December 31, 2011 and the quarter ended March 31, 2012, tell us the amount of third -party royalties included in cost of product revenues for each period . 3. It appears your cost of product revenues (including third party royalty expense on net sales) was only 6.7% of net product revenues for year 2011 and 6.9% for the quarter ended March 31, 2012 . Please tell us, by product (i.e. INCIVEK, KALYDECO) the amount of estimated revenues represented by inventory on hand at December 31, 2011 and March 31, 2012 for which manufacturing costs were expensed in prior periods as research and development expenses. Tell us when you expect to finish selling these inventories. 5 Ian F. Smith Executive Vice President , And Chief Financial Officer Vertex Pharmaceuticals Incorporated June 26, 2012 Page 3 Critical Accounting Policies And Estimates Revenue Recognition Product Revenues, Net , page 71 4. Although you discuss certain the aspects of health care reform legislation that affect the company (page 23), you do not quantify its historical impact on your financial statements for year 2011, particularly as to “rebates” expensed, nor do you disclose an estimate or range of estimates for the impact for year 2012. In this regard, please provide us proposed revised disclosure for year 2011 and for the quarterly period ended March 31, 2012 to be included in fu ture periodic reports, indicating the amount of the reduction to revenues for the increased Medicaid rebate and for additional rebates associated with the Medicare Part D “donut hole”. Also, include in your proposed revised disclosure the amount of the b randed prescription drug fee, if any, you recorded in your statement of earnings in 2011, in which line item it is classified therein and highlight that this fee is not tax deductible. Finally, if you believe that the expected effects of health care refor m legislation in 2012 and beyond will be materially different than the 2011 trends, include the expected effects in the proposed revised disclosure. Research and Development Expenses, page 76 5. It appears from the Table (page 65) that you expensed, as R&D Expenses, “ drug supply costs” of $8.0 million, $34.1million, $65.9 million and $21. 6 million in the quarter ended March 31, 2012 and the years 2011, 2010 and 2009 respectively. You further state that “Our total development expenses have been affected by t he variable level of drug supply costs, which include costs of raw materials and work in process that are incurred before we begin capitalizing inventories for a drug candidate and costs of manufacturing services that we provided our collaborators through our third -party manufacturing network.” Please tell us, citing specific authoritative literature, the basis for classifying “drug supply costs” as R&D expenses . Quantify and address in your analysis each type or category of cost. We urge all persons wh o are responsible for the accuracy and adequacy of the disclosure in the filing s to be certain that the filing s include the 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 they have made. In responding to our comment s, please provide a written statement from the company acknowledging t hat: the company is responsible for the adequacy and accuracy of the disclosure in the filing s; 5 Ian F. Smith Executive Vice President , And Chief Financial Officer Vertex Pharmaceuticals Incorporated June 26, 2012 Page 4 staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing s; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact James Peklenk, Staff Accountant, at (202) 551 -3661 or Lisa Vanjoske, Assistant Chief Accountant, at (202) 551 -3614 if you have any 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