SEC Company Response from SINOVAC BIOTECH LTD (SVA) (CIK 0001084201) (SVA) — Nov 28, 2005
SINOVAC BIOTECH LTD (SVA) (CIK 0001084201)
Date: Nov. 28, 2005 · CIK: 0001084201 · Accession: 0001127855-05-000757
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CORRESP 1 filename1.htm r>3C//DTD HTML 4.01 Transitional//EN"> Untitled Page Vancouver Office: D E V L I N P.O. Box 12077 J E N S E N Suite 2550 Barristers & Solicitors 555 West Hastings St. Vancouver, B.C. Canada V6B 4N5 Tel: (604) 684-2550 Fax: (604) 684-0916 E-mail: mshannon@devlinjensen.com File Reference: 4020\045a Via EDGAR October 3, 2005 SECURITIES AND EXCHANGE COMMISSION 450 Fifth Street, N.W. Washington, D.C. U.S.A., 20549-0405 Attention: Mr. Mark Brunhofer, Staff Accountant, Division of Corporation Finance Dear Mr. Brunhofer: Re: Sinovac Biotech Ltd. (the “Company”) File No. 1-32371 E-MAIL CORRESPONDENCE BETWEEN THE COMPANY AND THE SEC We are counsel for the above-referenced Company and are writing on its behalf. With respect to our telephone conversation on September 29, 2005, we have compiled the additional information set forth below relating to the SEC's further concerns and requests for information on the accounting treatment of the Licenses and Permits for Sinovac Biotech Ltd.'s recently filed Form 20-F/A-2. Association of Law Corporations Securities and Exchange Commission October 3, 2005 Page 2 When we acquired our vaccine licenses, we capitalized the excess of the purchase price over the fair value of the net tangible assets acquired (“purchased R&D costs”). The SEC has questioned whether or not the purchased R&D costs relating to the vaccines should have been capitalized, suggesting instead that expensing the costs would have been more appropriate. The SEC has further questioned when amortization of any capitalized costs should begin. Our policy is to commence amortization when production begins, but an alternative would be to commence amortization on the purchase of the vaccines. This discussion does not address the issue of amortization period. In principle, FASB Statement No. 2 requires that research and development expenses be expensed, unless alternative future use tests can be met. FASB Interpretation No. 4 provides further guidance in this regard with regard to purchased R&D costs. For purchased R&D costs to be recorded as an asset, there must be a “probable future economic benefit” (FASB Concepts Statement No. 6). In practical terms, we understand that normal US practice is to expense purchased R&D costs unless the drug in question has received FDA approval. In Sinovac’s case, we have to relate this test to the Chinese approval process which has four main elements: Clinical trial approval New drug certificate Production license GMP certification Sinovac Experience In general, under the Chinese system, we believe that there is a probable future economic benefit associated with a vaccine once the new drug certificate has been awarded. Obtaining a production license is straightforward when the new drug certificate requirements have been met, and is more related to production than the merits of the drug as such. The GMP certification relates more to the production facility than the vaccine itself. Once the new drug certificate has been received, the vaccine could be sold or licensed to a third party, which could in turn manufacture it. Of the three vaccines, we only had the new drug certificate at the purchase date for the hepatitis A vaccine: Securities and Exchange Commission October 3, 2005 Page 3 Milestone Hepatitis A Hepatitis A&B Influenza Purchase / contribution date April 2001 April 2002 March 2003 Clinical trial approval April 1998 March 2002 February 2003 New drug certificate December 1999 January 2005 February 2005 Production license May 2002 January 2005 July 2005 GMP certificate March 2002 May 2003 TBA Date amortization began July 2002 April 2005 TBA There are, however, other circumstances that affect Sinovac’s decision to capitalize the hepatitis A&B and influenza vaccine purchase costs. The hepatitis A&B vaccine is based on a combination of the company’s proprietary hepatitis A vaccine, which received its new drug certificate in 1999, and a third party’s hepatitis B vaccine which was already being marketed. Since the hepatitis A&B vaccine was a combination of two approved products, it believed that the test necessary to record an asset had been met. The influenza vaccine had been developed using a recognized production technique and accordingly, the Company believed there was a probable future benefit to be derived from this vaccine. Conclusion We hope that this information more fully explains the Chinese regulatory process and risk associated with the commercialization of Sinovac’s vaccines. We would like the opportunity to talk with you regarding your interpretation of this additional material. Yours very truly, DEVLIN JENSEN Per: /s/ Mike Shannon MICHAEL T. SHANNON