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BioMarin Announces Fourth Quarter and Full Year 2010 Financial Results
Date:2/17/2011

a non-GAAP adjusted EBITDA measure will be utilized, which is more aligned with management's internal goal setting process.  Non-GAAP information under the previous methodology for the fourth quarter and years ended 2010 and 2009, as well as the new adjusted EBITDA methodology for fiscal 2010 and guidance for 2011 is denoted on page 5 of this press release.  In addition, this non-GAAP adjusted EBITDA information has been provided on a pro-forma basis for the quarters and fiscal years for 2009 and 2010 in Appendix A for information purposes.   Anticipated Upcoming Milestones2Q 2011: Initiation of pivotal Phase III trial for Firdapse for LEMS in the U.S.Mid-2011: Top-line results from PEG-PAL Phase II trial, including daily dosing and formulation studiesLate 2011: 510k approval and commercial availability of the handheld blood Phe monitor for PKU1Q 2012: Initiation of Phase III PEG-PAL trial1Q 2012: Initiation of Phase I trial for BMN-111 for Achondroplasia1H 2012: NDA filing for Firdapse for LEMS in the U.S.2H 2012: Top-line results for Phase III trial for GALNS for MPS IVA2H 2012: Top-line results for PKU-016 Kuvan neurocognitive study4Q 2012: Approval of Firdapse for LEMS in the U.S.4Q 2012: Top-line results for Phase I/II trial for BMN-701 for Pompe disease4Q 2012/1Q 2013: Market authorization application filings for GALNS for MPS IVAResearch and Development ProgramsBioMarin continues to make significant investments in research and development to ensure continued growth of the company.  The current pipeline includes programs in various stages of development and is focused on treating a range of serious unmet medical needs.Advanced Clinical Programs

  • GALNS for MPS IVA: BioMarin initiated a randomized, double-blind, placebo-controlled Phase III study in early February 2011 with primary endpoint of six-minute walk distance, 24 weeks in treatment duration and treatment doses of two mg/kg/week and two mg/kg/every other week.  
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  • SOURCE BioMarin Pharmaceutical Inc.
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    2. BioMarin to Host Fourth Quarter and Full Year 2010 Financial Results
    3. BioMarin Initiates Phase 1/2 Trial for BMN 701 for the Treatment of Pompe Disease
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    5. BioMarin to Present at the J.P. Morgan 29th Annual Healthcare Conference
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    10. BioMarin Appoints William Young and Kenneth Bate to Its Board of Directors
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