NOVATO, Calif., Feb. 26 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. today announced financial results for the fourth quarter and full year ended December 31, 2007. Net income was $2.6 million ($0.03 per share) for the fourth quarter of 2007, compared to a net loss of $10.4 million ($0.11 per share) for the fourth quarter of 2006. Net income for the fourth quarter of 2007 includes the receipt of the $15.0 million milestone payment from Merck Serono related to the EMEA acceptance of the Kuvan filing for marketing approval. The net loss for the year ended December 31, 2007 was $15.8 million ($0.16 per share), compared to a net loss of $28.5 million ($0.34 per share) for the year ended December 31, 2006. Non-cash stock compensation expense for the three months and year ended December 31, 2007 was $5.5 million and $18.3 million, respectively, compared to $3.1 million and $9.6 million, respectively, for the three months and year ended December 31, 2006.
As of December 31, 2007, BioMarin had cash, cash equivalents, and short-term investments totaling $585.6 million.
“We achieved many significant milestones in 2007, most notably, the FDA approval of Kuvan and the filing of the IND for PEG-PAL for PKU,” said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. “We also continued building our pipeline with the in-licensing of promising compounds. As we look forward in 2008, we are focused on ensuring the successful commercial launch of Kuvan, further advancement of our research programs, and new in-licensing opportunities. Overall, we expect continued global expansion of Naglazyme and the U.S. launch of Kuvan to contribute to the improvement of our bottom line.”
Product Revenue
Net revenue from Naglazyme(R) (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), was $25.5 million for the fourth quarter of 2007, an increase of 56.4 percent compared to net revenue of $16.3 million for the fourth quarter of 2006. Net revenue from Naglazyme for the year ended December 31, 2007 was $86.2 million, an increase of 85.4 percent from net revenue of $46.5 million for the year ended December 31, 2006. BioMarin is commercializing Naglazyme in the United States, Europe, and Latin America, and through distributors in other international markets.
Net revenue from Aldurazyme(R) (laronidase), an enzyme replacement therapy for mucopolysaccharidosis I, (MPS I) recorded by BioMarin/Genzyme LLC increased by approximately 33.6 percent to $35.4 million for the fourth quarter of 2007, compared to $26.5 million in the fourth quarter of 2006. Net revenue from Aldurazyme for the year ended December 31, 2007 was $123.7 million, an increase of 28.5 percent compared to net revenue of $96.3 million for the year ended December 31, 2006. BioMarin’s share of the profit of BioMarin/Genzyme LLC was $9.4 million for the fourth quarter of 2007, compared to a profit of $5.7 million for the fourth quarter of 2006. For the year ended December 31, 2007, BioMarin’s share of the profit of BioMarin/Genzyme LLC was $30.5 million, compared to a profit of $19.3 million for the year ended December 31, 2006. Beginning January 1, 2008, as a result of the restructuring of the joint venture with Genzyme, BioMarin will receive 39.5 to 50 percent of worldwide net sales of Aldurazyme as product revenue and will also recognize additional product revenue related to the transfer of Aldurazyme inventory to Genzyme to meet future product demand.
Net product revenue from Kuvan(TM) (sapropterin dihydrochloride) Tablets, a product for the treatment of phenylketonuria (PKU), for the approximate two-week period after approval and launch in December 2007 was $0.4 million, which reflects initial shipments to a limited number of specialty pharmacies.
Collaborative Agreement Revenues
Collaborative agreement revenues for the fourth quarter of 2007 were $17.5 million, and include the $15 million milestone payment from Merck Serono for the filing of the MAA for Kuvan. Collaborative agreement revenues for the fourth quarter of 2006 were $4.9 million. Collaborative agreement revenues for the year ended December 31, 2007 were $28.3 million, compared to revenues of $18.7 million for the year ended December 31, 2006. Excluding the receipt of the $15 million milestone payment, collaborative agreement revenues decreased in 2007 as compared to 2006. This was due to decreased Kuvan research and development expenses reimbursable by Merck Serono resulting in decreased reimbursement revenue.
2008 Financial Guidance
BioMarin estimates 2008 net sales of Naglazyme will be in the range of $105 million to $116 million. BioMarin is updating its 2008 Kuvan net sales estimate to a range of $40 million to $70 million.
Net sales of Aldurazyme by Genzyme are estimated to be in the range of $135 million to $145 million. BioMarin’s revenue from Genzyme related to Aldurazyme is estimated to be between $68 million and $78 million, which includes both the royalty earned on net sales by Genzyme and additional product revenue related to the transfer of Aldurazyme inventory to Genzyme to meet future product demand. This guidance reflects the new arrangement with Genzyme and the related changes in BioMarin’s income statement presentation of Aldurazyme operations resulting from the restructuring of BioMarin/Genzyme LLC.
BioMarin estimates its Generally Accepted Accounting Principles (GAAP) net income for the fiscal year ending December 31, 2008 will be in the range of $20 million to $40 million which assumes that the $30 million milestone for EU Kuvan approval will be earned in 2008. The net income estimate includes approximately $27 million in non-cash stock compensation expense. Non-GAAP net income, excluding the impact of non-cash stock compensation, is estimated to be in the range of $47 million to $67 million.
Non-GAAP Financial Information and Reconciliation
The above 2008 financial guidance includes Management’s estimated net income determined in accordance with GAAP and non-GAAP net income, which is net income calculated in accordance with GAAP, but excluding Management’s estimate of non-cash stock compensation expense for 2008 of $27.0 million, a non-GAAP financial measure. The reconciliation of this measure to the estimated GAAP net income is as follows:
Management believes that this non-GAAP information is useful to investors, taken in conjunction with BioMarin’s GAAP net income guidance for 2008 because Management uses such information internally for its operating, budgeting and financial planning purposes, and to enhance investors’ overall understanding of the company’s prospects for the future.
BioMarin will host a conference call and webcast to discuss fourth quarter and full year 2007 financial results today, Tuesday, February 26, at 5:00 p.m. ET (22:00 CET). This event can be accessed on the investor section of the BioMarin website at http://www.BMRN.com.
About BioMarin
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio comprises three 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; and Kuvan(TM) (sapropterin dihydrochloride) Tablets, a product for the treatment of phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany. Other product candidates include 6R-BH4 for cardiovascular indications, which is currently in Phase 2 clinical development for the treatment of peripheral arterial disease and sickle cell disease, and PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of PKU. For additional information, please visit http://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, and Aldurazyme; the financial performance of the BioMarin as a whole; the timing of BioMarin’s clinical trials of 6R-BH4 for other indications and PEG-PAL; the continued clinical development and commercialization of Aldurazyme, Naglazyme, Kuvan, and 6R-BH4 for other indications; and actions by regulatory authorities. 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 and Kuvan; 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 and Kuvan; actual sales of Aldurazyme, Naglazyme and Kuvan; 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 2006 Annual Report on Form 10-K, as amended, and the factors contained in BioMarin’s reports on Form 10-Q and Form 8-K. 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) and Naglazyme(R) are a registered trademarks of BioMarin Pharmaceutical Inc.
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//
