GAAP net loss for the nine months ended September 30, 2009 was $5.2 million ($0.05 per diluted share), compared to GAAP net income of $6.3 million ($0.06 per diluted share) for the nine months ended September 30, 2008. Non-GAAP net income was $33.9 million ($0.33 per diluted share) for the nine months ended September 30, 2009, compared to non-GAAP net income of $21.9 million ($0.21 per diluted share) for the nine months ended September 30, 2008.
As of September 30, 2009, BioMarin had cash, cash equivalents and short and long-term investments totaling $491.8 million.
"During the quarter, we continued to advance our clinical pipeline as we completed enrollment for the Phase I/II study of GALNS for MPS IVA and initiated the Phase II trial of PEG-PAL for PKU. On the commercial front, we were issued patents covering stable tablet formulation and the once daily dosing regimen for Kuvan, and received claims covering the approved administration of Kuvan with food. We believe that these patents are significant in extending protection beyond orphan drug market exclusivity," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "Based on our performance to date, we have narrowed the guidance range on a few items to reflect increased visibility into the year, including improved expectations for the bottom line. Our commercial products are performing well, and we continue to carefully manage expenses. We are also carefully evaluating both internal pipeline programs and external product opportunities to maximize long-term value for both the company and our shareholders. Also, as announced earlier this week, we acquired Huxley Pharmaceuticals, which is developing a proprietary form of 3,4-DAP for the rare autoimmune disease Lambert Eaton Myasthenic Syndrome. A positive opinion was issued by the EMEA last week, and we expect to launch this product in the EU in the first quarter of 2010. This low-risk deal le
|SOURCE BioMarin Pharmaceutical Inc.|
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