NOVATO, Calif., Feb. 23 /PRNewswire-FirstCall/ --
BioMarin Pharmaceutical Inc. today announced financial results for the fourth quarter and year ended December 31, 2009. GAAP net income was $4.7 million ($0.05 per diluted share) for the fourth quarter of 2009, compared to GAAP net income of $24.5 million ($0.21 per diluted share) for the fourth quarter of 2008, which included a $30.0 million payment from Merck Serono related to the approval of Kuvan in the EU. Non-GAAP net income was $13.5 million ($0.13 per diluted share) for the fourth quarter of 2009, compared to non-GAAP net income of $8.0 million ($0.08 per diluted share) for the fourth quarter of 2008. 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 estimated GAAP net income is detailed in the table provided at the end of the press release.
GAAP net loss for the year ended December 31, 2009 was $0.5 million ($0.00 per diluted share), compared to GAAP net income of $30.8 million ($0.29 per diluted share) for the year ended December 31, 2008. Non-GAAP net income was $47.1 million ($0.46 per diluted share) for the year ended December 31, 2009, compared to non-GAAP net income of $30.0 million ($0.29 per diluted share) for the year ended December 31, 2008.
As of December 31, 2009, BioMarin had cash, cash equivalents and short and long-term investments totaling $470.5 million.
“Robust product sales of Naglazyme and Kuvan drove profitability in the fourth quarter and a strong finish to 2009. Commercially, we continue to aggressively pursue expansion of the Naglazyme and Kuvan markets and look forward to launching Firdapse in the EU in late March,” said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. “We also have much to look forward to in terms of clinical milestones in 2010, including results from the Phase I/II trial of GALNS for MPS IVA in the second quarter, results from the Phase II PEG-PAL trial in the third quarter of 2010, results from the Phase I trial of BMN 195 for DMD in the third quarter of 2010 and the IND filing for the recently acquired PARP inhibitor from LEAD Therapeutics. Even after factoring in the Huxley and LEAD acquisitions, we expect to be slightly cash flow positive in 2010.”
Net Product Revenue
Net product revenue from Naglazyme (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), was $44.4 million for the fourth quarter of 2009, an increase of 21.6 percent compared to Naglazyme net product revenue of $36.5 million for the fourth quarter of 2008. Net product revenue from Naglazyme for the year ended December 31, 2009 was $168.7 million, an increase of 27.1 percent from net product revenue of $132.7 million for the year ended December 31, 2008. Changes in foreign currency rates, net of hedges, caused an increase to Naglazyme sales of $0.6 million in the three months ended December 31, 2009 and a decrease of $4.4 million for the year ended December 31, 2009.
Net sales of Aldurazyme (laronidase), an enzyme replacement therapy for mucopolysaccharidosis I (MPS I) recorded by Genzyme, were $38.7 million for the fourth quarter of 2009, an increase of 2.9 percent compared to net sales of Aldurazyme by Genzyme of $37.6 million for the fourth quarter of 2008. Net sales of Aldurazyme recorded by Genzyme for the year ended December 31, 2009 were $155.1 million, compared to $151.3 million for the year ended December 31, 2008. Changes in foreign currency rates caused an increase to Aldurazyme sales by Genzyme of $2.4 million in the three months ended December 31, 2009 and a decrease of $6.3 million for the year ended December 31, 2009.
Net product revenue to BioMarin related to Aldurazyme was $16.8 million for the fourth quarter of 2009, compared to net product revenue to BioMarin of $14.4 million for the fourth quarter of 2008. During the fourth quarter of 2009, BioMarin transferred more inventory to Genzyme compared to units shipped to third party customers by Genzyme, which resulted in an increase in BioMarin net product revenue from the royalty payable to BioMarin by Genzyme. During the fourth quarter of 2008, BioMarin transferred less inventory to Genzyme compared to units shipped to third party customers by Genzyme, which resulted in a reduction in BioMarin net product revenue from the royalty payable to BioMarin by Genzyme. Net product revenue to BioMarin related to Aldurazyme was $70.2 million for the year ended December 31, 2009, compared to $72.5 million for the year ended December 31, 2008.
Net product revenue from Kuvan (sapropterin dihydrochloride) Tablets, a product for the treatment of phenylketonuria (PKU), was $22.7 million for the fourth quarter of 2009, compared to $15.1 million for the fourth quarter of 2008. Net product revenue from Kuvan for the year ended December 31, 2009 was $76.8 million, compared to net revenue of $46.7 million for the year ended December 31, 2008. The quantity of commercial tablets dispensed to patients in the U.S., the best metric to track true patient demand, increased 17.8 percent in the fourth quarter of 2009 compared to the third quarter of 2009.
Firdapse Launch Update
BioMarin is on track to launch Firdapse for LEMS in the EU on a country by country basis beginning in late March. Firdapse pricing has been filed in Germany at 23 Euros per 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 be between 10,000 and 50,000 Euros per year.
Research and Development Programs
BioMarin continues to make significant investments in research and development to ensure continued growth of the company. The current pipeline includes programs which are in various stages of development and are focused on treating a range of unmet medical needs. BioMarin is making significant investments in manufacturing and laboratory facilities to support the advancement of these programs.
Advanced Programs
Mid-Stage Programs
Preclinical Programs
Non-GAAP Financial Information and Reconciliation
The above results for the quarter and year ended December 31, 2009 and 2008 and financial guidance for 2010 are presented both as determined in accordance with GAAP and on a non-GAAP basis. As used in this release, non-GAAP income is calculated in accordance with GAAP, but excludes non-cash stock compensation expense, certain nonrecurring material items and the tax effect of the adjustments. The following tables detail the reconciliation of non-GAAP to GAAP financial metrics:
BioMarin believes that this non-GAAP information is useful to investors, taken in conjunction with BioMarin’s GAAP information because it provides additional information regarding the performance of BioMarin’s core ongoing business, Naglazyme, Kuvan and Aldurazyme and development of its pipeline. By providing information about both the overall GAAP financial performance and the non-GAAP measures that focus on continuing operations, the company believes that the additional information enhances investors’ overall understanding of the company’s business and prospects for the future. Further, the company uses both the GAAP and the non-GAAP results and expectations internally for its operating, budgeting and financial planning purposes.
Diluted Earnings Per Share Calculation
The calculation of GAAP diluted earnings per share for the fourth quarter of 2008 and non-GAAP diluted earnings per share for the fourth quarter of 2009 includes 26.3 million shares related to the outstanding convertible debt. The calculation of non-GAAP diluted earnings per share for full year 2009 includes 16.0 million shares associated with the 2017 notes but excludes the 10.3 million shares associated with the 2013 notes as their impact is considered anti-dilutive. These calculations reflect the exclusion of the interest expense from net earnings that would no longer be incurred if the Company’s convertible notes were converted into shares.
Conference Call Details
BioMarin will host a conference call and webcast to discuss fourth quarter and full year 2009 financial results today, Tuesday, February 23, at 5:00 p.m. ET. This event can be accessed on the investor section of the BioMarin website at www.BMRN.com.
About BioMarin
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine phosphate), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Other product candidates include PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU; GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase I/II clinical development for the treatment of MPS IVA and BMN 195, which is currently in Phase I clinical development for the treatment of Duchenne Muscular Dystrophy. For additional information, please visit www.BMRN.com. Information on BioMarin’s website is not incorporated by reference into this press release.
Forward-Looking Statement
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the expectations of revenue and sales related to Naglazyme, Kuvan, Firdapse, and Aldurazyme; the financial performance of the BioMarin as a whole; the timing of BioMarin’s clinical trials of PEG-PAL, GALNS, BMN-195 and other product candidates; the continued clinical development and commercialization of Aldurazyme, Naglazyme, Kuvan, Firdapse, and its product candidates; and actions by regulatory authorities, particularly with respect to the recently acquired Firdapse. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: our success in the continued commercialization of Naglazyme, Kuvan, and Firdapse; Genzyme Corporation’s success in continuing the commercialization of Aldurazyme; results and timing of current and planned preclinical studies and clinical trials; our ability to successfully manufacture our products and product candidates; the content and timing of decisions by the U.S. Food and Drug Administration, the European Commission and other regulatory authorities concerning each of the described products and product candidates; the market for each of these products and particularly Aldurazyme, Naglazyme, Kuvan and Firdapse; actual sales of Aldurazyme, Naglazyme Kuvan and Firdapse; Merck Serono’s activities related to Kuvan; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s 2008 Annual Report on Form 10-K, and the factors contained in BioMarin’s reports on Form 10-Q. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin(R), Naglazyme(R) and Kuvan(R) are registered trademarks of BioMarin Pharmaceutical Inc.
Firdapse(TM) is a trademark of BioMarin Huxley Ltd.
Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC.
CONTACT: Investors, Eugenia Shen, +1-415-506-6570, or Media, Susan Berg,
+1-415-506-6594, both of BioMarin Pharmaceutical Inc.
Web site: http://www.bmrn.com/
