Financial Highlights ($ in millions, except per share data, unaudited) | |||
Item | Q2 2010 | Q2 2009 Comparison | |
Total BioMarin Revenue | $92.0 | 11.1% increase | |
Total Net Product Revenue | $90.6 | 11.2% increase | |
Naglazyme Net Product Revenue | $47.3 | 10.3% increase | |
Aldurazyme BioMarin Net Product Revenue* | $17.5 | $21.6 | |
Kuvan Net Product Revenue | $24.7 | 45.3% increase | |
Firdapse Net Product Revenue | $1.1 | NA | |
GAAP Net Income (Loss) | $(0.5) | $1.3 | |
GAAP Net Income (Loss) per share | $(0.00) (basic), | $0.01 (basic and diluted) | |
Non-GAAP Net Income | $8.6 | $9.0 | |
Non-GAAP Net Income per share | $0.08 (basic and diluted) | $0.09 (basic and diluted) | |
* Net product transfer revenue had a negative $0.2 million impact on net | |||
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced financial results for the second quarter of 2010. GAAP net loss was $0.5 million ($0.01 per diluted share) for the second quarter of 2010, compared to GAAP net income of $1.3 million ($0.01 per diluted share) for the second quarter of 2009. Non-GAAP net income was $8.6 million ($0.08 per diluted share) for the second quarter of 2010, compared to non-GAAP net income of $9.0 million ($0.09 per diluted share) for the second 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.
GAAP net income for the six months ended June 30, 2010 was $0.7 million ($0.01 per diluted share), compared to GAAP net loss of $11.8 million ($0.12 per diluted share) for the six months ended June 30, 2009. Non-GAAP net income was $17.4 million ($0.17 per diluted share) for the six months ended June 30, 2010, compared to non-GAAP net income of $18.4 million ($0.18 per diluted share) for the six months ended June 30, 2009.
As of June 30, 2010, BioMarin had cash, cash equivalents and short and long-term investments totaling $455.4 million, as compared to $452.4 million at the end of March 31, 2010.
"Our pipeline has advanced tremendously over the last few months with encouraging preliminary safety and efficacy data from the PEG-PAL trial, positive discussions with regulatory authorities regarding the GALNS Phase III trial design, a clear development strategy for Firdapse in the U.S. and initiation of the Kuvan outcomes study is expected imminently. Also, we generated operating cash flow of $22.2 million in the second quarter of 2010, compared to $3.3 million in the first quarter of 2010," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "With our solid commercial foundation and advancing pipeline, we believe that we are well-positioned for long-term growth. We look forward to many additional clinical milestones in the second half of the year and remain committed to investing in the pipeline to drive additional value for the company."
Net Product Revenue (in millions) | |||||||||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2009 | 2010 | $ Change | % Change | 2009 | 2010 | $ Change | % Change | ||||||||||||||||
Naglazyme (1) | $ | 42.9 | $ | 47.3 | $ | 4.4 | 10.3% | $ | 82.3 | $ | 95.9 | $ | 13.6 | 16.5% | |||||||||
Kuvan (2) | 17.0 | 24.7 | 7.7 | 45.3% | 32.5 | 45.9 | 13.4 | 41.2% | |||||||||||||||
Firdapse (3) | 1.1 | 1.1 | 100.0% | 1.2 | 1.2 | 100.0% | |||||||||||||||||
(1) Changes in foreign currency rates, net of hedges, had a $1.4 million and $1.5 million negative impact on Naglazyme sales in the three months and six months ended June 30, 2010, respectively. Naglazyme revenues experience quarterly fluctuations due to the timing of distributor purchases. The number of Naglazyme patients increased 4.9 percent in the second quarter of 2010, as compared to the first quarter of 2010, and increased 21.8 percent as compared to the second quarter of 2009.
(2) The quantity of commercial tablets dispensed to patients in the U.S., increased 36.6 percent in the second quarter of 2010 compared to the second quarter of 2009 and increased 14.7 percent in the second quarter of 2010 compared to the first quarter of 2010.
(3) A product for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS) which was launched in the EU in April 2010.
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||
2009 | 2010 | $ Change | % Change | 2009 | 2010 | $ Change | % Change | ||||||||||||||||||||
Aldurazyme revenue reported by Genzyme (4) | $ | 39.2 | $ | 43.7 | $ | 4.5 | 11.5% | $ | 76.0 | $ | 83.5 | $ | 7.5 | 9.9% | |||||||||||||
Royalties due from Genzyme | 15.5 | 17.7 | 2.2 | 30.0 | 33.7 | 3.7 | |||||||||||||||||||||
Incremental (previously recognized) Aldurazyme product transfer revenue | 6.1 |