BioMarin Announces Fourth Quarter and Full Year 2011 Financial Results
R&D Pipeline Advancing; Many Key Clinical Milestones in the Coming Year
Net Product Revenue Growth of 18 Percent in 2011
Conference Call and Webcast to be Held Today at 5:00 p.m. ET
Financial Highlights ($ in millions, except per share data, unaudited)
* Net product transfer revenue had a positive $8.6 million impact on net Aldurazyme revenue to BioMarin in 2011 and a positive $3.2 million impact on net Aldurazyme revenue to BioMarin in 2010.
** During the third quarter of 2010, the company reversed its deferred tax asset valuation allowance and recorded a one-time benefit of $223.1 million.
NOVATO, Calif., Feb. 16, 2012 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced financial results for the fourth quarter and full year 2011. GAAP net loss was $26.7 million ($0.23 per diluted share) for the fourth quarter of 2011, compared to GAAP net loss of $12.2 million ($0.11 per diluted share) for the fourth quarter of 2010. Non-GAAP adjusted EBITDA was a loss of $3.0 million for the fourth quarter of 2011, compared to non-GAAP adjusted EBITDA of $11.0 million for the fourth quarter of 2010. Non-GAAP adjusted EBITDA excludes depreciation and amortization, contingent consideration expense, interest income and expense, income taxes, stock compensation expense and material non-recurring items. The reconciliation of the non-GAAP measures to the comparable GAAP measure is detailed in the table provided near the end of the press release.
GAAP net loss for the year ended December 31, 2011 was $53.8 million ($0.48 per diluted share), compared to GAAP net income of $205.8 million ($1.73 per diluted share) for the year ended December 31, 2010. During the third quarter of 2010, the company reversed its deferred tax asset valuation allowance and recorded a one-time benefit of $223.1 million. Non-GAAP adjusted EBITDA was $34.5 million for the year ended December 31, 2011, compared to non-GAAP adjusted EBITDA of $62.0 million for the year ended December 31, 2010.
As of December 31, 2011, BioMarin had cash, cash equivalents and short and long-term investments totaling $289.5 million, as compared to $370.0 million on September 30, 2011. The decline in the cash balance is due to a payment of $81.0 million for the purchase of Naglazyme royalty rights from the Adelaide Health Authority in the fourth quarter of 2011.
"The successful execution of our R&D pipeline to deliver therapies that have a meaningful impact in the lives of patients remains the top priority for BioMarin in 2012. Our most advanced clinical program, the Phase 3 trial for MPS IVA, is progressing well, and we anticipate that over 160 patients will be enrolled by mid-March. This is a month earlier than previously communicated thanks to enthusiasm for the study in the MPS IV community," said Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin. "Our growing commercial portfolio is funding the majority of our R&D expenses, and we look forward to many key clinical milestones in the coming year, including data readouts for GALNS for MPS IVA, PEG-PAL for PKU, BMN-701 for Pompe disease and BMN-673 for solid tumors."
Net Product Revenue (in millions)
(1) Changes in foreign currency rates, net of hedges, had a negative $1.3 million impact on Naglazyme sales in the fourth quarter of 2011 and negative $0.2 million impact on Naglazyme sales for the year ended December 31, 2011. The number of Naglazyme patients increased 11.9 percent in the fourth quarter of 2011 compared to the fourth quarter of 2010. Naglazyme revenues experience quarterly fluctuations due to the timing of government ordering patterns in certain countries.
(2) The quantity of commercial tablets dispensed to patients in the U.S. increased 10.3 percent in the fourth quarter of 2011 compared to the fourth quarter of 2010.
(3) A product for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS) which was launched in the EU in April 2010.
(4) Changes in foreign currency rates caused a decrease to Aldurazyme sales by Genzyme of $0.6 million and an increase to Aldurazyme sales by Genzyme of $5.6 million for the three months and year ended December 31, 2011, respectively.
(5) To the extent units shipped to third party customers by Genzyme exceeded BioMarin inventory transfers to Genzyme, BioMarin will record a decrease in net product revenue from the royalty payable to BioMarin for the amount of previously recognized product transfer revenue. If BioMarin inventory transfers exceed units shipped to third party customers by Genzyme, BioMarin will record incremental net product transfer revenue for the period.
* Approximately $45 million of the $255 million to $265 million is for the production of drug supply for clinical studies.
** Net cash usage in 2011 includes a payment of $81 million for the purchase of Naglazyme royalty rights and a payment of $48.5 million related to the acquisition of the Shanbally manufacturing facility.
*** Cash balance includes cash, cash equivalents and short and long term investments.
Anticipated Upcoming Milestones
Research and Development Programs
BioMarin continues to make significant investments in research and development to ensure persistent growth for the company. The current pipeline includes programs in various stages of development that are focused on treating a range of serious unmet medical needs.
Advanced Clinical Programs
Mid-Stage Clinical Programs
Early-Stage Clinical Programs
Non-GAAP Financial Information and Reconciliation
The above results for the three months and year ended December 31, 2011 and December 31, 2010 and financial guidance for the year ending December 31, 2012 are presented both as determined in accordance with GAAP and on a non-GAAP basis. As used in this release, non-GAAP income is based on GAAP Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) adjusted to exclude non-cash stock compensation expense, contingent consideration expense and certain nonrecurring material items (Non-GAAP Adjusted EBITDA).
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, Aldurazyme and Firdapse 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 and uses the Non-GAAP Adjusted EBITDA methodology in establishing corporate goals for internal compensation programs.
Diluted Earnings Per Share Calculation
The following table sets for the computation of GAAP diluted earnings per share:
Conference Call Details
BioMarin will host a conference call and webcast to discuss fourth quarter and full year 2011 financial results today, Thursday, February 16, at 5:00 p.m. ET. This event can be accessed on the investor section of the BioMarin website at www.BMRN.com.
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® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan® (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse™ (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, amifampridine phosphate (3,4-diaminopyridine phosphate), which is currently in Phase III clinical development for the treatment of LEMS in the U.S., PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers, and BMN-111, a modified C-nutriuretic peptide, which is currently in Phase I clinical development for the treatment of achondroplasia. For additional information, please visit www.BMRN.com. Information on BioMarin's website is not incorporated by reference into this press release.
The BioMarin Pharmaceutical Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=11419
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, 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 GALNS, Firdapse, PEG-PAL, BMN-673, BMN-701, BMN-111 and other product candidates; the continued clinical development and commercialization of Aldurazyme, Naglazyme, Kuvan, Firdapse, and its product candidates; 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, 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, particularly with respect to GALNS, Firdapse, PEG-PAL, BMN-673, BMN-701 and BMN-111; 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 2010 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®, Naglazyme®, Kuvan® and Firdapse™ are registered trademarks of BioMarin Pharmaceutical Inc.
Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.
CONTACT: Investors Eugenia Shen BioMarin Pharmaceutical Inc. (415) 506-6570 Media Bob Purcell BioMarin Pharmaceutical Inc. (415) 506-3267
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