SEC Comment Letter for NOVARTIS AG (NVS, NVSEF) (CIK 0001114448) (NVS) — Sep 9, 2011
NOVARTIS AG (NVS, NVSEF) (CIK 0001114448)
Date: Sept. 9, 2011 · CIK: 0001114448 · Accession: 0000000000-11-054164
AI Filing Summary & Sentiment
Letter
September 9, 2011 Via E-mail Mr. Jonathan Symonds Chief Financial Officer Novartis AG Lichtstrasse 35 4056 Basel, Switzerland
Re: Novartis AG Form 20-F for Fiscal Year Ended December 31, 2010 Filed January 27, 2011 File No. 1-15024
Dear Mr. Symonds: We have reviewed your August 26, 2011 re sponse to our July 29, 2011 comment letter and have the following comment. We c ontinue to evaluate your responses to prior comments three and four and may have additional comments. Please respond to this letter within te n business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe the comment applies to your fact s and circumstances, please tell us why in your response. Please furnish us a le tter on EDGAR under the form type label CORRESP that keys your response to our comment. After reviewing the information provi ded, we may raise additional comments and/or request that you amend your filing. Item 4.B Business Overview
Pharmaceuticals Compounds in Development, page 38
1. We have reviewed the information provi ded in your response to prior comment two. We acknowledge that you are unable to estimate the remaining patent life of your confirmatory development project s without making significant judgments and assumptions and your concern that disclosure of identifying information about your patents could cause competi tive harm. Based on the information in your response, however, it appears that th at there is information available to understand potential exclusivity periods within a reasonable range for those development compounds in phase III on pa ges 38-42. Please provide us revised proposed disclosure to disclose info rmation for each development compound
Mr. Jonathan Symonds Novartis AG September 9, 2011 Page 2 designated as approved or in registrati on. These ranges could be expressed as a “floor-to-ceiling” exclusivity range based on currently known information, indicating the extent that th e range represents exclusivit y due to patents, without indicating the name or othe r identifying information about the patent, versus other exclusivity available, and indicating unde r what conditions and to what extent each “floor-to-ceiling” may be affected by fu ture delays in the approval process or by other factors. Also, we believe that si milar disclosure at the aggregate level for all development projects in Phase III not ye t in registration would be informative. Please revise your proposed disclosure accordingly by providing a separate narrative section discussing generally the floors and cei lings associated with exclusivity for these projects and indicating the factors that may effect the ceilings and floors. To the extent there may be outliers not covered by the general narrative, identify them and expl ain the reasons therefore. Please contact Frank Wyman, Staff Acc ountant, at (202) 551-3660 or Mark Brunhofer, Senior Staff Acc ountant, at (202) 551-3638, if you have any questions regarding this comment. In th is regard, do not hesitate to contact me at (202) 551-3679.
Sincerely, /s/ Jim B. Rosenberg
Jim B. Rosenberg
Senior Assistant Chief
Accountant
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September 9, 2011 Via E-mail Mr. Jonathan Symonds Chief Financial Officer Novartis AG Lichtstrasse 35 4056 Basel, Switzerland Re: Novartis AG Form 20-F for Fiscal Year Ended December 31, 2010 Filed January 27, 2011 File No. 1-15024 Dear Mr. Symonds: We have reviewed your August 26, 2011 re sponse to our July 29, 2011 comment letter and have the following comment. We c ontinue to evaluate your responses to prior comments three and four and may have additional comments. Please respond to this letter within te n business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe the comment applies to your fact s and circumstances, please tell us why in your response. Please furnish us a le tter on EDGAR under the form type label CORRESP that keys your response to our comment. After reviewing the information provi ded, we may raise additional comments and/or request that you amend your filing. Item 4.B Business Overview Pharmaceuticals Compounds in Development, page 38 1. We have reviewed the information provi ded in your response to prior comment two. We acknowledge that you are unable to estimate the remaining patent life of your confirmatory development project s without making significant judgments and assumptions and your concern that disclosure of identifying information about your patents could cause competi tive harm. Based on the information in your response, however, it appears that th at there is information available to understand potential exclusivity periods within a reasonable range for those development compounds in phase III on pa ges 38-42. Please provide us revised proposed disclosure to disclose info rmation for each development compound Mr. Jonathan Symonds Novartis AG September 9, 2011 Page 2 designated as approved or in registrati on. These ranges could be expressed as a “floor-to-ceiling” exclusivity range based on currently known information, indicating the extent that th e range represents exclusivit y due to patents, without indicating the name or othe r identifying information about the patent, versus other exclusivity available, and indicating unde r what conditions and to what extent each “floor-to-ceiling” may be affected by fu ture delays in the approval process or by other factors. Also, we believe that si milar disclosure at the aggregate level for all development projects in Phase III not ye t in registration would be informative. Please revise your proposed disclosure accordingly by providing a separate narrative section discussing generally the floors and cei lings associated with exclusivity for these projects and indicating the factors that may effect the ceilings and floors. To the extent there may be outliers not covered by the general narrative, identify them and expl ain the reasons therefore. Please contact Frank Wyman, Staff Acc ountant, at (202) 551-3660 or Mark Brunhofer, Senior Staff Acc ountant, at (202) 551-3638, if you have any questions regarding this comment. In th is regard, do not hesitate to contact me at (202) 551-3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant