BioMarin has posted GAAP net income of $1.3m ($0.01 per diluted share) for the second quarter of 2009, compared to GAAP net income of $3.8m ($0.04 per diluted share) for the second quarter of 2008. Non-GAAP net income was $9.0m ($0.09 per diluted share) for the second quarter of 2009, compared to non-GAAP net income of $9.7m ($0.09 per diluted share) for the second quarter of 2008.
GAAP net loss for the six months ended June 30, 2009 was $11.8m ($0.12 per diluted share), compared to GAAP net income of $5.5m ($0.05 per diluted share) for the six months ended June 30, 2008. Non-GAAP net income was $18.4m ($0.18 per diluted share) for the six months ended June 30, 2009, compared to non-GAAP income of $13.8m ($0.13 per diluted share) for the six months ended June 30, 2008.
Jean-Jacques Bienaime, chief executive officer of BioMarin, said: During the quarter, we reported encouraging results from the Phase I PEG-PAL study, initiated the Phase I/II study for GALNS for MPS IVA and recently completed enrollment for this study, a noteworthy milestone for this program. On the commercial front, we announced earlier today the issuance of patents covering stable tablet formulation and the once daily dosing regimen for Kuvan, which we believe will be significant in extending patent protection an additional ten years beyond orphan drug market exclusivity. In addition, yesterday, we submitted the Kuvan NDS to Health Canada. With priority review status, we anticipate marketing approval in the first half of 2010. Also, during the quarter, we received approval for Naglazyme in Russia, which is especially significant as Russia influences many countries in Eastern Europe. In order to support the projected commercial needs for Naglazyme, Aldurazyme, GALNS and PEG-PAL through at least 2016, we are making significant investments to double our manufacturing capacity.
Based on our performance to date, we feel confident in meeting our overall top and bottom line financial objectives for 2009 and have narrowed the guidance range on a few items to reflect increased visibility into the year. 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.