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BioMarin Pharmaceutical Inc. Reports Operating Results (10-K)

February 24, 2011 | About:
10qk

10qk

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BioMarin Pharmaceutical Inc. (BMRN) filed Annual Report for the period ended 2010-12-31.

Biomarin Pharmaceutical Inc. has a market cap of $2.66 billion; its shares were traded at around $25.99 with and P/S ratio of 7.1. Hedge Fund Gurus that owns BMRN: Stanley Druckenmiller of Duquesne Capital Management, LLC, Bruce Kovner of Caxton Associates, Jim Simons of Renaissance Technologies LLC, Steven Cohen of SAC Capital Advisors. Mutual Fund and Other Gurus that owns BMRN: Columbia Wanger of Columbia Wanger Asset Management, Richard Aster Jr of Meridian Fund, PRIMECAP Management, RS Investment Management, Pioneer Investments, Chuck Royce of Royce& Associates.

Highlight of Business Operations:

Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date: 110,723,087 shares common stock, par value $0.001, outstanding as of February 15, 2011. The aggregate market value of the voting and non-voting stock held by non-affiliates of the registrant as of June 30, 2010 was $1,026.3 million.

Naglazyme received marketing approval in the United States (U.S.) in May 2005, in the European Union (EU) in January 2006 and subsequently in other countries. Kuvan was granted marketing approval in the U.S. and EU in December 2007 and December 2008, respectively. In December 2009, the European Medicines Agency (EMEA) granted marketing approval for Firdapse, which was launched in the EU in April 2010. Aldurazyme, which was developed in collaboration with Genzyme Corporation (Genzyme) was approved in 2003 for marketing in the U.S., EU and subsequently other countries. Net product revenues for 2010 for our approved products, Naglazyme, Kuvan, Firdapse and Aldurazyme were $192.7 million, $99.4 million, $6.4 million and $71.2, respectively.

Naglazyme was granted marketing approval in the U.S. in May 2005 and in the EU in January 2006. We market Naglazyme in the U.S., EU, Canada, Latin America, and Turkey using our own sales force and commercial organization. Additionally, we use local distributors in several other regions to help us pursue registration and/or market Naglazyme on a named patient basis. Naglazyme net product sales for 2010 totaled $192.7 million, as compared to $168.7 million for 2009. Naglazyme net product sales for 2008 were $132.7 million.

Kuvan was granted marketing approval for the treatment of PKU in the U.S. in December 2007. We market Kuvan in the U.S. and Canada using our own sales force and commercial organization. Kuvan has been granted orphan drug status in the U.S., which confers seven years of market exclusivity in the U.S for the treatment of PKU, expiring in 2014. We expect that our patents will provide market exclusivity beyond the expiration of orphan status. Kuvan net product sales for 2010 were $99.4, as compared to $76.8 million for 2009. Kuvan net product sales for the 2008 were $46.7 million.

In May 2005, we entered into an agreement with Merck Serono for the further development and commercialization of Kuvan and any other product containing 6R-BH4, and PEG-PAL for PKU. Through the agreement, as amended in 2007, Merck Serono acquired exclusive rights to market these products in all territories outside the U.S., Canada and Japan, and we retained exclusive rights to market these products in the U.S. and Canada. We and Merck Serono currently share equally all development costs following successful completion of Phase 2 clinical trials for each product candidate in each indication. Merck Serono launched Kuvan in the EU in the second quarter of 2009 and they are launching in other countries. Under the agreement with Merck Serono, we are entitled to receive royalties, on a country-by-country basis, until the later of the expiration of patent right licensed to Merck or ten years after the first commercial sale of the licensed product in such country. Over the next several years, we expect a royalty of approximately 4% on net sales of Kuvan by Merck Serono. We also sell Kuvan to Merck Serono at near cost, and Merck Serono resells the product to end-users outside the U.S., Canada and Japan. The royalty earned from Kuvan product sold by Merck Serono in the EU is included as a component of net product revenues in the period earned. In 2010, we earned $0.9 million in net royalties on net sales of $23.7 million of Kuvan by Merck Serono, compared to 2009 when we earned $0.3 million in net royalties on net sales of $6.9 million. We recorded collaborative agreement revenue associated with Kuvan in the amounts of $0.7 million in 2010, $2.4 million in 2009 and $38.9 million in 2008.

Aldurazyme net product revenues totaled $71.2 million for 2010 as compared to $70.2 million for 2009 and $72.5 million for 2008. The net product revenues for 2010, 2009 and 2008 include $68.0 million, $61.8 million and $60.1 million, respectively, of royalty revenue on net Aldurazyme sales by Genzyme. Royalty revenue from Genzyme is based on 39.5% to 44.0% of net Aldurazyme sales by Genzyme, which totaled $166.8 million for 2010, $155.1 million for 2009 and $151.3 million for 2008. Incremental Aldurazyme net product transfer revenue of $3.2 million, $8.4 million and $12.4 million for 2010, 2009 and 2008, respectively, reflect incremental shipments of Aldurazyme to Genzyme to meet future product demand. In the future, to the extent that Genzyme Aldurazyme inventory quantities on hand remain consistent, we expect that our total Aldurazyme revenues will approximate the 39.5% to 50% royalties on net product sales by Genzyme.

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