BioMarin Pharmaceutical

BioMarin Pharmaceutical, Inc. engages in the development and commercialization of therapies for people with serious and life-threatening rare diseases and medical conditions. Its pipeline products include Valoctocogene roxaparvovec, Vosoritide, and BMN 307. The company was founded by John C. Klock, Christopher M. Starr and Grant W. Denison on March 21, 1997, and is headquartered in San Rafael, CA.

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BioMarin excels in Q4 with record revenues and gene therapy launch

BioMarin Pharmaceutical reported strong financial results in Q4 2022, achieving revenue growth, profitability, and successful introduction of the ROCTAVIAN gene therapy for hemophilia A.
The company's performance highlights its R&D capabilities, market positioning, and strategic readiness for upcoming product launches, positioning BioMarin for continued growth and innovation.
While facing challenges in reimbursement processes and regulatory requirements, BioMarin has opportunities to drive revenue expansion, market penetration, and address unmet medical needs through its innovative pipeline.

BioMarin reports strong Q1 earnings, eyes blockbuster status for ROCTAVIAN

BioMarin Pharmaceuticals had a robust Q1 2023, focusing on revenue growth, profitability, and commercial readiness for key drug launches. While facing challenges in Germany, the company is optimistic about the potential of ROCTAVIAN and VOXZOGO in driving future growth.

BioMarin excels in Q2 with record revenues and treatment milestones

BioMarin's strong Q2 performance, driven by record revenues and product demand, positions the company for growth.
Challenges like supply issues and site readiness are being addressed, while opportunities in new programs and markets are promising.
Overall, BioMarin's focus on compliance, expansion, and pipeline development sets a positive trajectory for future success.

BioMarin reports strong Q3 revenue growth, eyes Roctavian expansion

BioMarin's Q3 performance showed revenue growth driven by Voxzogo, with strong expectations for 2024 revenue.
New CEO Alexander Hardy is set to continue the core strategy, focusing on Roctavian's global launch and Voxzogo's growth potential.
Challenges include delays in Roctavian's takeoff and supply constraints for Voxzogo, but efforts are underway to address these issues.
Opportunities lie in Roctavian's revenue contribution, Voxzogo's U.S. growth potential, and leveraging CNP for stature improvements.

BioMarin posts robust Q4 earnings, eyes expansion in gene therapy

BioMarin Pharmaceutical delivered strong financial results in Q4 2023, driven by revenue growth and increased earnings per share. The company's focus on high-impact medicines and gene therapy expertise positions it well for future growth.
While facing challenges related to analyst inquiries and market adoption of key products like Roctavian and Voxzogo, BioMarin remains committed to innovation and optimizing its business model.
Opportunities lie in expanding product reach, maximizing shareholder value through strategic capital allocation, and driving innovation in transformative programs. BioMarin's long-term strategy and growth potential remain promising.

BioMarin reports record revenue, focuses on key assets for growth

BioMarin Pharmaceutical's Q1 2024 performance reflects strong revenue growth and financial stability, driven by key product demand.
While facing challenges such as revenue impact and supply constraints, the company's strategic focus on key assets and cost reduction initiatives bode well for future growth.
Opportunities lie in expanding Voxzogo's market reach, optimizing manufacturing capabilities, and maintaining a competitive edge in innovative treatments.

BioMarin Pharmaceuticals reports record revenue and profitability outlook for 2024

BioMarin Pharmaceuticals delivered strong financial performance in Q2 2024, driven by robust revenue growth and strategic decisions. The company's focus on profitability, expansion of key treatments, and progress in R&D highlight a promising outlook. Addressing analyst inquiries and leveraging upcoming events can further enhance investor confidence and market positioning.

BioMarin reports record Q3 revenues, eyes long-term growth targets

BioMarin Pharmaceuticals showcased robust financial performance and raised full-year guidance.
The company remains optimistic about its long-term growth prospects and is committed to defending its IP.
Strategic focus on expanding global reach and driving growth in enzyme therapies portfolio.

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Growth of VOXZOGO® Accelerated with Rapid Uptake in Japan and Brazil Resulting in Increased Full-year 2023 Guidance Full-year 2023 Top-line and Bottom-line Financial Guidance Reaffirmed; ROCTAVIAN™ Net Product Revenue Guidance Adjusted for Full-year 2023 In Germany, Growing Pipeline of People with Severe Hemophilia A Getting Tested for ROCTAVIAN Treatment Eligibility; ROCTAVIAN U.S. Launch Preparations Underway Ahead of June 30 Prescription Drug User Fee Act (PDUFA) Target Action Date Financial Highlights  (in millions of U.S. dollars, except per share data, unaudited) Three Months Ended March 31, 2023 2022 % Change Total Revenues $       596.4 $       519.4 15 % Total Enzyme Product Revenues (1) $       448.1 $       426.5 5 % VIMIZIM® Net Product Revenues $       189.2 $       183.0 3 % NAGLAZYME® Net Product Revenues $       123.0 $       128.0 (4) % VOXZOGO Net Product Revenues $         87.8 $         19.7 346 % PALYNZIQ® Net Product Revenues $         62.4 $         54.9 14 % KUVAN® Net Product Revenues $         50.5 $         59.3 (15) % BRINEURA® Net Product Revenues $         39.1 $         36.2 8 % ALDURAZYME® Net Product Revenues $         34.4 $         24.4 41 % GAAP Net Income (2) $         50.9 $       120.8 Non-GAAP Income (3) $       115.8 $         98.8 GAAP Diluted Earnings per Share (EPS) $         0.27 $         0.63 Non-GAAP Diluted EPS (4) $         0.60 $         0.52   March 31, 2023 December 31, 2022 Total cash, cash equivalents & investments $               1,492.7 $               1,625.4 (1) Enzyme-based products include ALDURAZYME, BRINEURA, NAGLAZYME, PALYNZIQ, and VIMIZIM. (2) GAAP Net income in the first quarter of 2022, included a $89.0 million net gain, net of taxes related to the sale of the Rare Pediatric Disease Priority Review Voucher (PRV) the Company received from the U.S. Food and Drug Administration (FDA) in connection with U.S. approval of VOXZOGO.

BioMarin Announces Record Breaking First Quarter 2023 Results, Including 15% Year-over-year Growth of Total Revenues

LONDON--(BUSINESS WIRE)--MiNA Therapeutics, the pioneer of small activating RNA (RNAa) therapeutics, today announced a multi-target research collaboration and option licensing agreement with BioMarin Pharmaceutical Inc. The collaboration will allow for the discovery, and potential development and commercialization of RNAa therapeutic candidates targeting a number of rare genetic diseases. Under the agreement, BioMarin will employ MiNA Therapeutics' proprietary RNAa algorithm and technology plat.

MiNA Therapeutics Enters Research Collaboration with BioMarin Pharmaceutical to Advance RNAa Platform Research in Rare Genetic Diseases

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BioMarin presents with attractive business economics that warrants a constructive view. The firm's revenue ramp looks steep and this could pull through to strong owner earnings to drive value for shareholders.

BioMarin: Growth Could Come With Tremendous Profit Potential

SAN RAFAEL, Calif. , April 13, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Wednesday, April 26, at 4:30 p.m.

BioMarin to Host First Quarter 2023 Financial Results Conference Call and Webcast on Wednesday, April 26, at 4:30pm ET

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New Analyses from Phase 2 and Phase 3 Extension Studies Continue to Demonstrate Sustained Improvement in Growth with no Change in Safety Profile SAN RAFAEL, Calif. , March 14, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, will present updated data demonstrating the long-term benefit of treatment with VOXZOGO® (vosoritide) and new observational data on disease burden in children with achondroplasia.

BioMarin to Share Updated Data at 2023 American College of Medical Genetics and Genomics (ACMG) Meeting Demonstrating Commitment to Understanding Long-Term Benefit of VOXZOGO® in Children with Achondroplasia

The FDA accepts BioMarin's (BMRN) label-expansion filing for Voxzogo to treat children under five years with achondroplasia. The agency extends the review period for Roctavian BLA.

BioMarin (BMRN) Provides FDA Filing Update for Gene Therapies

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The Supplemental New Drug Application is Based on Positive Results from Global Randomized Phase 2 Study in Infants and Young Children FDA set PDUFA Target Action Date of October 21, 2023 SAN RAFAEL, Calif. , March 7, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for injection to expand treatment in the United States to include children with achondroplasia under the age of 5.

FDA Accepts BioMarin's Supplemental New Drug Application to Expand Use of VOXZOGO® (vosoritide) for Injection to Treat Children with Achondroplasia Under the Age of 5

BioMarin Pharmaceutical Inc. BMRN, -6.82% said Tuesday that the Food and Drug Administration pushed back the deadline to make a decision whether to approve the company's experimental gene therapy for adults with severe hemophilia A to June 30. BioMarin told investors that the regulator considers a three-year data analysis from the Phase 3 clinical trial to be a major amendment to the submission.

FDA now set to decide on BioMarin's hemophilia drug by June 30

FDA Extends PDUFA Target Action Date to June 30, 2023 SAN RAFAEL, Calif. , March 6, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that it received notice this afternoon from the U.S. Food and Drug Administration (FDA) that the agency has extended review of the company's Biologics License Application (BLA) for ROCTAVIAN™ (valoctocogene roxaparvovec) gene therapy for adults with severe hemophilia A.

BioMarin Provides Update on FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) Gene Therapy for Adults with Severe Hemophilia A

Shares of BioMarin Pharmaceutical Inc. BMRN, +1.08% were down about 6.0% in premarket trading on Monday after BridgeBio Pharma Inc. BBIO, -0.09% shared positive Phase 2 clinical data about its experimental dwarfism drug, which could compete with BioMarin's Voxzogo if and when it's approved. BioMarin received Food and Drug Administration approval for Voxzogo as a treatment for some children 5 years old and older with achondroplasia in late 2021.

BioMarin's stock falls after another company's dwarfism drug moves into Phase 3 clinical trials

Cowen Healthcare Conference on March 8 in Boston Barclays Global Healthcare Conference on March 15 in Miami Jefferies Biotech on the Bay Summit on March 16 in Miami SAN RAFAEL, Calif. , March 2, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that management will participate in three upcoming investor conferences in March.

BioMarin to Participate in Three Investor Conferences in March

BioMarin (BMRN) reports mixed Q4 results as it misses estimates for earnings but beats the same for sales. Its 2023 sales guidance falls short slightly

BioMarin (BMRN) Q4 Earnings Miss, Sales Beat, Stock Down

The headline numbers for BioMarin (BMRN) give insight into how the company performed in the quarter ended December 2022, but it may be worthwhile to compare some of its key metrics to Wall Street estimates and the year-ago actuals.

Compared to Estimates, BioMarin (BMRN) Q4 Earnings: A Look at Key Metrics

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN ) Q4 2022 Results Conference Call February 28, 2023 4:30 PM ET Company Participants Traci McCarty - Group VP, IR JJ Bienaimé - Chairman and CEO Jeff Ajer - EVP and Chief Commercial Officer Hank Fuchs - President, Worldwide R&D Greg Guyer - EVP and Chief Technical Officer Brian Mueller - EVP and CFO Conference Call Participants Salveen Richter - Goldman Sachs Geoff Meacham - Bank of America Phil Nadeau - Cowen and Company Jessica Fye - JPMorgan Chase Chris Raymond - Piper Sandler Matthew Harrison - Morgan Stanley Paul Matteis - Stifel Lachlan Hanbury-Brown - William Blair Josh Schimmer - Evercore ISI Operator Welcome to the BioMarin Fourth Quarter Investor Update Call. Hosting the conference call today from BioMarin is Traci McCarty, Group Vice President of Investor Relations.

BioMarin Pharmaceutical Inc. (BMRN) Q4 2022 Earnings Call Transcript

BioMarin (BMRN) delivered earnings and revenue surprises of -7.69% and 0.69%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

BioMarin Pharmaceutical (BMRN) Q4 Earnings Lag Estimates

VOXZOGO $169 Million Contribution Drives Record Full Year 2022 Total Revenues of $2.1 Billion In 2023, More than 15% Growth in Total Revenues and Approximately 30% Growth in Net Income Expected Based on Mid-point of Today's Full-year Guidance; VOXZOGO Revenues Expected to More than Double ROCTAVIAN European Commercial Launch and U.S. Launch Preparations Both Underway; 3-year Analysis from Phase 3 ROCTAVIAN Study in Adults with Severe Hemophilia A Recently Submitted to the FDA Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) Three Months Ended December 31, Twelve Months Ended December 31, 2022 2021 % Change 2022 2021 % Change Total Revenues $       537.5 $        449.8 19 % $    2,096.0 $     1,846.3 14 % Net Product Revenues Marketed by BioMarin (1) $       487.9 $        414.9 18 % $    1,913.6 $     1,660.7 15 % VIMIZIM® Net Product Revenues $       152.1 $        156.3 (3) % $       663.8 $        623.1 7 % NAGLAZYME® Net Product Revenues $       100.5 $          83.1 21 % $       443.8 $        380.4 17 % PALYNZIQ® Net Product Revenues $         72.3 $          63.8 13 % $       255.0 $        237.5 7 % VOXZOGO Net Product Revenues $         66.8 $            5.8 1,052 % $       169.1 $            5.9 2,766 % KUVAN® Net Product Revenues $         53.6 $          68.5 (22) % $       227.6 $        285.8 (20) % BRINEURA® Net Product Revenues $         42.6 $          37.4 14 % $       154.3 $        128.0 21 % ALDURAZYME® Net Product Revenues $         37.6 $          20.3 85 % $       128.4 $        122.8 5 % GAAP Net Income (Loss) $          (0.2) $         (57.9) $       141.6 $         (64.1) GAAP Earnings (Loss) per Share – Basic $        (0.00) $         (0.32) $         0.76 $         (0.35) GAAP Earnings (Loss) per Share – Diluted $        (0.00) $         (0.32) $         0.75 $         (0.35) Non-GAAP Income (2) $         67.4 $            7.1 $       364.6 $        242.8 December 31, 2022 December 31, 2021 Total cash, cash equivalents & investments $              1,625.4 $               1,521.7 (1) Net Product Revenues Marketed by BioMarin is the sum of revenues from VIMIZIM, NAGLAZYME, PALYNZIQ, KUVAN, VOXZOGO and BRINEURA for the three and twelve months ended December 31, 2022 and 2021, each calculated in accordance with Generally Accepted Accounting Principles in the United States (U.S. GAAP). Sanofi is BioMarin's sole customer for ALDURAZYME and is responsible for marketing and selling ALDURAZYME to third parties.

BioMarin Announces Record Fourth Quarter and Full Year 2022 Total Revenues Driven by Strong Global Demand for VOXZOGO® and Steady Growth of Enzyme Business

SAN RAFAEL, Calif. , Feb. 14, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer and Brian Mueller, Executive Vice President, Chief Financial Officer of BioMarin will participate virtually in the SVB Securities Global Biopharma Conference on Thursday, February 16, 2023, at 11:20 a.m.

BioMarin to Participate Virtually at SVB Securities Global Biopharma Conference on February 16, 2023

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SAN RAFAEL, Calif. , Feb. 7, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Monday, February 27, at 4:30 p.m.

BioMarin to Host Fourth Quarter and Full-Year 2022 Financial Results Conference Call and Webcast on Monday, February 27, at 4:30 p.m. ET

With subsequent follow-through days mounting and stocks refusing to give up ground, this rally is showing it might be for real. The post BMRN Stock An Example Of Stock Market Character Change appeared first on Investor's Business Daily.

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BioMarin has a core cadre of molecules with modestly growing revenues. Its VOXZOGO has clear blockbuster potential.

News for BioMarin Pharmaceutical Stock (BMRN)