SEC Comment Letter for NOVARTIS AG (NVS, NVSEF) (CIK 0001114448) (NVS) — Jun 22, 2009
NOVARTIS AG (NVS, NVSEF) (CIK 0001114448)
Date: June 22, 2009 · CIK: 0001114448 · Accession: 0000000000-09-032778
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File numbers found in text: 001-15024
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Via Facsimile and U.S. Mail Mail Stop 4720 June 11, 2009 Dr. Daniel Vasella, M.D. Chairman and Chief Executive Officer Novartis, Inc. Lichtstrasse 35 4056 Basel, Switzerland Re: Novartis, Inc. Form 20-F for the Fiscal Year Ended December 31, 2008 Filed January 28, 2009 File No. 001-15024 Dear Dr. Vasella: We have reviewed your filing and have the following comments. We have limited our review to your financial statements a nd related disclosures and do not intend to expand our review to other portions of your document. In our comments, we ask you to provide us with information to better unde rstand your disclosure. Where a comment requests you to revise disclosure, the information you provide should show us what the revised disclosure will look like and identify the annual or quarterly filing, as applicable, in which you intend to first include it. If you do not believe that revised disclosure is necessary, explain the reason in your response. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. 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. Item 5. Operating and Financial Review and Prospects 5.C Research & Development, Patents and Licenses, page 140 1. You disclose the expiration of patents protecting a number of the top 20 products in your Pharmaceuticals Division, expected “at risk” launches of generic products Dr. Daniel Vasella, M.D. Novartis, Inc. June 11, 2009 Page 2 and ongoing competition from approved ge neric products, which will lead to significant decreases in y our net sales. Also, you disclose substantive compound development activities in your Pharmaceuti cals Division that a ppear to indicate likely future product launches. Please revi se your disclosure to identify those compounds in development that are reasonabl y likely to result in future product launches and quantify the related market oppor tunities that you e xpect to exploit. In addition for each of these compounds in development, disclose the anticipated completion dates and estimated costs to complete development and the period in which resulting net cash inflows are expect ed to commence. To the extent that you are unable to provide this information, disclose those facts and circumstances indicating the uncertain ties that preclude you from making a reasonable estimate. Item 18. The Novartis Group Consolidated Financial Statements Notes to the Novartis Group Cons olidated Financial Statements 1. Accounting policies Research & development, page F-17 2. Please provide us with an analysis that demonstrates how your policy for capitalizing initial upfront payments and subsequent milestone payments, once the required criteria are met, complies with paragraph 57 of IAS 38. Revise your disclosure to describe “re quired criteria” and how the cr iteria are applied (i.e. on a payment-by-payment basis). 3. Revise your disclosure to describe the factors that you consider in determining that R&D activity has produced a “saleable product.” 4. Please explain to us how your recognition of non-qualifying R&D expenses on a percentage-of-completion basis complies w ith IAS 38. Revise your disclosure to explain how this policy is applied. 11. Deferred tax assets a nd liabilities, page F-41 5. Based on your history of profits, please re vise your disclosure to clarify why you believe that it is not probable that future taxable profits will be available to utilize the losses not capitalized. In particular , ensure that your revised disclosure addresses the guidance in para graphs 24 and 44 of IAS 12. * * * * Dr. Daniel Vasella, M.D. Novartis, Inc. June 11, 2009 Page 3 Please respond to these comments within 10 business days or tell us when you will provide us with a response. Your letter should key your responses to our comments. Detailed letters greatly facilitate our revi ew. Please furnish your letter on EDGAR under the form type label CORRESP. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes all in formation required under the Securities Exchange Act of 1934 and th at they have provided all information investors require for an informed invest ment decision. Since the company and its management are in possession of all facts re lating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In connection with responding to our co mments, please provide, in your letter, a statement from the company acknowledging that: • the company is responsible for the adequacy and accuracy of the disclosure in the filing; • 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; and • the company may not assert staff comme nts as a defense in any proceeding initiated by the Commission or any person under the federal secu rities laws of the United States. In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Divi sion of Corporation Fi nance in our review of your filing or in response to our comment on your filing. Please contact Frank Wyman, Staff A ccountant, at (202) 551-3660 or Don Abbott, Senior Staff Accountant, at (202) 551-3608, if you have any questions regarding these comments. In this regard, do not he sitate to contact me, at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant