 | Gibson, Dunn & Crutcher LLP
555 Mission Street San Francisco, CA 94105-0921 Tel 415.393.8200 www.gibsondunn.com | |
Ryan A. Murr Direct: +1 415.393.8373 Fax: +1 415.374.8430 RMurr@gibsondunn.com | ||
July 17, 2014
VIA EDGAR
Jim B. Rosenberg
Senior Assistant Chief Accountant
U.S. Securities and Exchange Commission
100 F Street, N.E.
Mail Stop 3030
Washington, D.C. 20549
| Re: | Avanir Pharmaceuticals, Inc. |
Form 10-K for the Fiscal Year Ended September 30, 2013
Filed December 11, 2013
File No. 001-15803
Dear Mr. Rosenberg:
On behalf of Avanir Pharmaceuticals, Inc. (“Avanir” or the “Company”), we are responding to the Staff’s oral comment from July 7, 2014 (the “Comment”), relating to the above-referenced filing on Form 10-K. For your convenience, we have repeated the Comment below inbold face type before the Company’s response, which is set forth initalics.
| 1. | We note your proposed enhanced research and development disclosure. Please confirm that you will also provide the research and development expenses by product candidate for each period presented in the financial statements and the inception-to-date period, in addition to the periods proposed. |
The Company confirms that it will provide the enhanced disclosure for the periods presented in the applicable periodic report, as well as from inception to date, to the extent that such information is readily available. As discussed with the Staff, the Company does not have R&D expense information broken out by programfor AVP-923prior to approximatelyOctober 1, 2000.Although the Company began developingAVP-923 in approximately 1999, the Company does not have access to itemized R&D expense information for this programprior to approximatelyOctober 1, 2000. Thus, as indicated in the draft disclosure below, the Company proposes to present the available inception-to-date information, and disclose the limitations on the available data where the presentation has been truncated or understated. The Company will providedevelopment expenseinformation for allother productsfor the periods presented in the applicable periodic report, as well as from inception to date.
Beijing • Brussels • Century City • Dallas • Denver • Dubai • Hong Kong • London • Los Angeles • Munich
New York • Orange County • Palo Alto • Paris • San Francisco • São Paulo • Singapore • Washington, D.C.
July 17, 2014
Page 2
The following table presents the Company’s proposed revised disclosure, which: (i) covers a three-year period (reflecting presentation in the Company’s annual report; for quarterly reports on Form 10-Q, the presentation would reflect a two-year period),(ii) reflects the inception-to-date data and (iii) provides certain supplemental disclosure. In addition, the Company has added a line titled “All other costs” to account for costs that are not allocated by product, such as payroll costs and certain consulting costs.
Year Ended | ||||||||||||||||
| Inception to Date (1) | September 30, | |||||||||||||||
| (In millions) | 2013 | 2012 | 2011 | |||||||||||||
Product candidateAVP-923(2) | $ | [XX | ] | $ | [XX | ] | $ | [XX | ] | $ | [XX | ] | ||||
Product candidateAVP-786(2) | [XX | ] | [XX | ] | [XX | ] | [XX | ] | ||||||||
Product candidateAVP-825(2) | [XX | ] | [XX | ] | [XX | ] | [XX | ] | ||||||||
Approved product(s) (2) | [XX | ] | [XX | ] | [XX | ] | ||||||||||
All other costs (3) | [XX | ] | [XX | ] | [XX | ] | ||||||||||
Total | $ | [XX | ] | $ | [XX | ] | $ | [XX | ] | |||||||
| (1) | The date of inception varies for each product candidate. For AVP-923, the table includes development costs from October 1, 2000 to present date. However, the development of AVP-923 commenced in 1999. |
For AVP-786, the date of inception occurred in the second fiscal quarter of 2012. For AVP-825, date of inception occurred in the fourth fiscal quarter of 2013.
| (2) | Includes costs such as non-clinical, clinical research, regulatory, supply chain, etc. |
| (3) | Includes unallocated costs such as salaries and wages and certain consulting costs, other outside expenses and medical affairs. |
The Company intends to include this R&D expense table in the Company’s quarterly report on Form 10-Q for the quarter ending June 30, 2014.
* * * * *
July 17, 2014
Page 3
We appreciate the Staff’s assistance with respect to the Company’s filing and look forward to resolving any concerns the Staff may have. If you have any questions, please contact me at (415) 393-8373.
| Sincerely, |
| /s/ Ryan A. Murr |
| Ryan A. Murr |
| Gibson, Dunn & Crutcher LLP |
| cc: | Christine G. Ocampo, Avanir Pharmaceuticals, Inc. |