NOVATO, Calif., April 29 /PRNewswire-FirstCall/ --

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced financial results for the first quarter of 2010. GAAP net income was $1.2 million ($0.01 per diluted share) for the first quarter of 2010, compared to GAAP net loss of $13.2 million ($0.13 per diluted share) for the first quarter of 2009. Non-GAAP net income was $8.8 million ($0.08 per diluted share) for the first quarter of 2010, compared to non-GAAP net income of $9.3 million ($0.09 per diluted share) for the first quarter of 2009. Non-GAAP net income excludes non-cash stock compensation expense, certain nonrecurring material items and the tax effect of the adjustments. The reconciliation of the non-GAAP measures to the GAAP net income is detailed in the table provided near the end of the press release.

As of March 31, 2010, BioMarin had cash, cash equivalents and short and long-term investments totaling $452.4 million.

“The year 2010 is off to a solid start, with several milestones already reached, including the recent launch of Firdapse in the EU and positive results from the Phase I/II trial for GALNS for the treatment of MPS IVA, with details in a separate press release issued this afternoon,” said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. “In addition to the positive results from the Morquio Phase I/II trial released today, we also look forward to additional clinical milestones in 2010 including results from the Phase I trial of BMN-195 for DMD in the second quarter of 2010, results from the Phase II PEG-PAL trial in the third quarter of 2010, the IND filing for BMN-673 and the initiation of the Phase III trial for GALNS in the fourth quarter of 2010.”

Net Product Revenue

Net product revenue from Naglazyme (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), was $48.6 million for the first quarter of 2010, an increase of 23.4 percent compared to Naglazyme net product revenue of $39.4 million for the first quarter of 2009. Naglazyme sales in the three months ended March 31, 2010 were not significantly impacted by changes in foreign currency rates, net of hedges.

Net sales of Aldurazyme (laronidase), an enzyme replacement therapy for mucopolysaccharidosis I (MPS I) recorded by Genzyme, were $39.9 million for the first quarter of 2010, an increase of 8.4 percent compared to net sales of Aldurazyme by Genzyme of $36.8 million for the first quarter of 2009. Changes in foreign currency rates caused an increase to Aldurazyme sales by Genzyme of $1.7 million in the three months ended March 31, 2010.

Net product revenue to BioMarin related to Aldurazyme was $14.2 million for the first quarter of 2010, compared to net product revenue to BioMarin of $17.0 million for the first quarter of 2009. During the first quarter of 2010, units shipped to third party customers by Genzyme exceeded BioMarin inventory transfers to Genzyme, which resulted in a decrease in BioMarin net product revenue from the royalty payable to BioMarin by Genzyme of $1.7 million. During the first quarter of 2009, BioMarin inventory transfers exceeded units shipped to third party customers by Genzyme, which resulted in an increase of $2.5 million in BioMarin net product revenue from the royalty payable to BioMarin by Genzyme.

Net product revenue from Kuvan (sapropterin dihydrochloride) Tablets, a product for the treatment of phenylketonuria (PKU), was $21.2 million for the first quarter of 2010, an increase of 36.8 percent compared to $15.5 million for the first quarter of 2009. The quantity of commercial tablets dispensed to patients in the U.S., increased 36.9 percent in the first quarter of 2010 compared to the first quarter of 2009 and decreased 7.2 percent in the first quarter of 2010 compared to the fourth quarter of 2009. Kuvan sales and patient referral trends improved in April, and the company continues to expect that 2010 Kuvan revenue will be in the range of $98 million to $108 million.

Firdapse Launch Update

BioMarin launched Firdapse for LEMS in the EU in mid-April, starting with Germany and the UK. Firdapse pricing has been filed in Germany at 23 Euros per 10mg tablet. Since dosages can range from 15 mg to 60 mg a day, the annual cost of therapy can vary widely from patient to patient. BioMarin estimates that the annual cost will range between 10,000 and 50,000 Euros per year.