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biomarin pharmaceutical inc (BM8) Snapshot

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09/19/13 - €63.51
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biomarin pharmaceutical inc (BM8) Details

BioMarin Pharmaceutical Inc. develops and commercializes biopharmaceuticals for serious diseases and medical conditions in the United States, Europe, Latin America, and internationally. Its commercial products include Naglazyme, a recombinant form of N-acetylgalactosamine 4-sulfatase enzyme for the treatment of mucopolysaccharidosis VI; Kuvan, a proprietary synthetic oral form of 6R-BH4 used to treat patients with phenylketonuria (PKU), a metabolic disease; Aldurazyme used for the treatment of mucopolysaccharidosis I, a genetic disease; Firdapse used to treat Lambert Eaton Myasthenic Syndrome, an autoimmune disease; and Vimizim, an enzyme replacement therapy to treat MPS IVA, a lysosomal storage disorder. The company also develops PEG-PAL, an enzyme substitution therapy that is under Phase III clinical trial to treat PKU; BMN-701, an enzyme replacement therapy, which is under Phase I/II clinical trial for Pompe disease, a glycogen storage disorder; BMN-673, a poly ADP-ribose polymerase inhibitor that is in Phase III clinical trial to treat germline BRCA breast cancer; and BMN-111, a C-natriuretic peptide that is under Phase I clinical trial to treat achondroplasia. In addition, it develops BMN 190, a recombinant human tripeptidyl peptidase-1 in Phase 1 clinical trial to treat late-infantile neuronal ceroid lipofuscinosis, a form of Batten Disease; BMN 270, an AAV-factor VIII vector to treat hemophilia A; and BMN 250, a novel fusion of alpha-N-acetyglucosaminidase to treat MPS IIIB. The company sells its Naglazyme, Kuvan, and Firdapse products to specialty pharmacies and end-users, such as hospitals and foreign government agencies, which act as retailers; and Naglazyme products to distributors and pharmaceutical wholesalers. It has a collaboration agreement with Genzyme Corporation; and an agreement with Merck Serono S.A. BioMarin Pharmaceutical Inc. was founded in 1996 and is headquartered in San Rafael, California.

Founded in 1996

biomarin pharmaceutical inc (BM8) Top Compensated Officers

Chief Executive Officer and Director
Total Annual Compensation: $868.8K
Chief Financial Officer and Executive Vice Pr...
Total Annual Compensation: $457.8K
Chief Medical Officer and Executive Vice Pres...
Total Annual Compensation: $631.9K
Senior Vice President, Secretary and General ...
Total Annual Compensation: $409.6K
Chief Commercial Officer and Executive Vice P...
Total Annual Compensation: $332.6K
Compensation as of Fiscal Year 2013.

biomarin pharmaceutical inc (BM8) Key Developments

BioMarin Pharmaceutical Revised Earnings Guidance for 2014

BioMarin Pharmaceutical Inc. announced its sale of the Rare Pediatric Disease Priority Review Voucher (the PRV) that the Company received in connection with the approval of VIMIZIM . In consideration for the sale of the PRV, the Company received $67.5 million from Regeneron Ireland (Regeneron), an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals Inc. The Company also announced in the Press Release updated full year 2014 revenue guidance, as of July 30, 2014, which included proceeds from the one-time sale of the PRV to Regeneron. The Company has since completed its evaluation of the transaction under the relevant U.S. Generally Acceptance Accounting Principles (U.S. GAAP) guidance and has determined that the appropriate classification of the transaction is a Gain on the Sale of Intangible Assets within the operating section of the Company's Statement of Comprehensive Loss for the period. As a result of this determination, the Company is adjusting previously announced full year 2014 revenue guidance to exclude from Total BioMarin Revenues the $67.5 million gain from the sale of the PRV. As a result of this adjustment, Total BioMarin Revenues decreased from a range of $745 million to $765 million to a range of $680 million to $700 million, inclusive of the Company's net product revenues, collaboration agreement revenues, royalty, license and other revenues. This change does not impact product revenue, GAAP or Non-GAAP earnings guidance, only the 2014 Total BioMarin Revenue guidance.

BioMarin Pharmaceutical Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2014; Revises Earnings Guidance for the Year 2014

BioMarin Pharmaceutical Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2014. For the quarter, the company reported total revenues of $191,787,000 against $136,810,000 a year ago. Loss from operations from operations was $18,882,000 against $20,052,000 a year ago. Loss before income taxes was $27,728,000 against $20,291,000 a year ago. Net loss was $33,502,000 against $21,533,000 a year ago. Basic and diluted loss per share was $0.23 against diluted loss per share of $0.16 a year ago. Non-GAAP net income was $10,800. Non-GAAP net loss per diluted share was $0.06. EBITDA loss was $9,300 against $26,700 a year ago. For the six months, the company reported total revenues of $343,339,000 against $264,738,000 a year ago. Loss from operations from operations was $45,338,000 against $52,973,000 a year ago. Loss before income taxes was $62,352,000 against $64,812,000 a year ago. Net loss was $71,617,000 against $61,343,000 a year ago. Diluted loss per share was $0.50 against $0.46 a year ago. Non-GAAP net income was $91,000 against non-GAAP net loss of $8,000 a year ago. Non-GAAP net income per diluted share was $0.05 against non-GAAP net loss per diluted share of $0.06 a year ago. EBITDA loss was $44,900 against $106,100 a year ago. For the year 2014, the company revises total company revenues to be $745,000 to $765,000 against $650,000 to $680,000. GAAP net loss expected to be $180,000 to $195,000 against $255,000 to $285,000. Non-GAAP net loss is expected to be $60,000 to $80,000 against $100,000 to $130,000. The company increasing Naglazyme net product revenue from the previous range of $290,000 to $310,000 now to a higher range of $305,000 to $320,000.

BioMarin Pharmaceutical Inc. and Sarah Cannon Research UK Collaborate on Ongoing Phase 3 Clinical Trial of its PARP Inhibitor

BioMarin Pharmaceutical Inc. and Sarah Cannon Research UK announced a collaboration to enroll patients in an ongoing Phase 3 clinical trial of its PARP inhibitor, BMN 673, for the treatment of hereditary breast cancer with a BRCA mutation. This ongoing Phase 3 trial has recently been named EMBRACA. Sarah Cannon Research UK enrolled the first patient outside of the United States, expanding the trial internationally. The EMBRACA Phse 3 study began in the United states in the fall of 2013 and has expanded internationally. BioMarin plans to enroll patients from sites around the world and to work with partners outside of the United States. The EMBRACA Phase 3 study is an open-label, randomized, parallel, two-arm, multi-center study of BMN 673 versus physician's choice in approximately 430 germline BRCA mutation patients with locally advanced and/or metastatic breast cancer, who have received no more than two prior chemotherapy regimens for metastatic disease. The primary objective of the study is to measure progression free survival (PFS). Secondary objectives include evaluating the objective response rate (ORR) and the overall survival (OS). BRCA1 and BRCA2 are human genes that belong to a class of genes known as tumor suppressors. Mutation of these genes has been linked to hereditary breast and ovarian cancer. A woman's risk of developing breast and/or ovarian cancer is greatly increased if she inherits a deleterious (harmful) BRCA1 or BRCA2 mutation. Men with these mutations also have an increased risk of breast cancer. Both men and women who have harmful BRCA1 or BRCA2 mutations may also be at increased risk of other cancers.


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