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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BioMarin Pharmaceutical Inc. revenues for Q3 of 2022 came in at $505.3 million, which was a year-over-year growth of 24%. It has potential to receive U.S. marketing approval of ROCTAVIAN for the treatment of adults with severe Hemophilia A; PDUFA date established for March 31, 2023.

BioMarin: Opportunity To Score Home Run With Latest Regulatory Advancements

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- Mean Annualized Bleed Rate Reduced by 80% from Baseline and Factor VIII Usage Reduced by 94% in Year 3 Compared to Baseline   - 92% of Patients off Prophylaxis at the End of Year 3 - First Outcomes-Based Agreement (OBA) Recently Signed in Germany; Additional Agreements Expected to be Signed in Coming Weeks  - U.S. Food and Drug Administration Pre-License Inspection of Manufacturing Facility Complete   SAN RAFAEL, Calif. , Jan. 8, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced positive results from more than three years of follow up from its ongoing global Phase 3 GENEr8-1 study of ROCTAVIANTM (valoctocogene roxaparvovec), an investigational one-time gene therapy for the treatment of adults with severe hemophilia A.

BioMarin Announces Stable and Durable Annualized Bleed Control for ROCTAVIAN™ in Largest Phase 3 Gene Therapy Study in Adults with Severe Hemophilia A; 134-Participant Study Met All Primary and Secondary Efficacy Endpoints at 3-Year Analysis

The EMA validates BioMarin's (BMRN) label expansion filing for Voxzogo to treat children under two years with achondroplasia. BMRN submits a filing for using Voxzogo in children under five years.

BioMarin's (BMRN) Voxzogo Expanded Label Filing Accepted by EMA

SAN RAFAEL, Calif. , Jan. 4, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer, will present at  the 41st Annual J.P.

BioMarin to Present at 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9, at 10:30 am PT /1:30 pm ET, in San Francisco, CA

BioMarin Submits Supplemental New Drug Application to U.S. Food and Drug Administration to Expand Label to Treat Children with Achondroplasia Under the Age of 5 Submissions Based on Favorable Results from Global Randomized Phase 2 Study in Infants and Young Children Demonstrating Increase of Growth Velocity in All Cohorts by Age Potential to Benefit More than 1,000 Eligible Children in U.S. and Europe Action by Health Authorities Expected in 2H 2023 SAN RAFAEL, Calif. , Jan. 3, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, announced today that the European Medicines Agency (EMA) validated its Type II Variation application to extend the indication for VOXZOGO® (vosoritide) for injection to treat children with achondroplasia under the age of 2.

European Medicines Agency Validates Application for Extension of Indication for VOXZOGO® (vosoritide) for injection to Treat Children with Achondroplasia Under the Age of 2

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BioMarin Pharmaceutical - Solutions For Rare Illnesses

BioMarin broke out after the FDA said it wouldn't hold an advisory committee meeting on its hemophilia A gene therapy. The post Biotech Stock BioMarin Scores Breakout After FDA Announcement appeared first on Investor's Business Daily.

Biotech Stock BioMarin Scores Breakout After FDA Announcement

BioMarin (BMRN) reported earnings 30 days ago. What's next for the stock?

Why Is BioMarin (BMRN) Up 14.1% Since Last Earnings Report?

The FDA decides not to hold an advisory committee meeting for BioMarin Pharmaceuticals' (BMRN) regulatory filing seeking approval for hemophilia A gene therapy, valrox.

BioMarin (BMRN) Up After FDA Scraps AdCom Meet for BLA Filing

Biomarin Pharmaceutical Inc (NASDAQ: BMRN) shares are trading higher by 6.97% to $97.54 Wednesday morning after the company announced advancements in the FDA review of ROCTAVIAN for adults with severe hemophilia A. What Else?

Why Biomarin Pharmaceutical Stock Hit A New 52-Week High Today - Biomarin Pharmaceutical (NASDAQ:BMRN)

FDA No Longer Plans to Hold an Advisory Committee Meeting, as Previously Planned, to Discuss the Biologics License Application (BLA) BioMarin Remains on Track to Host Scheduled Manufacturing Inspections by FDA in the Coming Weeks SAN RAFAEL, Calif. , Nov. 23, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced advancements in the U.S. Food and Drug Administration (FDA) review of the Biologics License Application (BLA) of ROCTAVIAN™ (valoctocogene roxaparvovec AAV gene therapy) for adults with severe hemophilia A.

BioMarin Announces Advancements in FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) for Adults with Severe Hemophilia A

FDA Pre-Licensure Inspection of Gene Therapy Manufacturing Facility Scheduled FDA Requests Submission of Upcoming 3-Year Data Analysis from Phase 3 GENEr8-1 Study Current PDUFA Target Action Date of March 31, 2023, Could Be Extended by 3 Months, If 3-Year Data Submission Deemed a Major Amendment SAN RAFAEL, Calif. , Nov. 7, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today a progress update on its Biologics License Application (BLA) for valoctocogene roxaparvovec AAV gene therapy for adults with severe Hemophilia A that is currently under review by the U.S. Food and Drug Administration (FDA).

BioMarin Announces Incremental Progress on Biologics License Application (BLA) Review for Valoctocogene Roxaparvovec AAV Gene Therapy for Adults with Severe Hemophilia A Program

Credit Suisse 31st Annual Healthcare Conference 2022: November 8th, 8:35amPT/11:35amET, in Rancho Palos Verdes, CA 13th Annual Jefferies Global Healthcare Conference 2022: November 16th, 8:35amGMT, in London, England SAN RAFAEL, Calif. , Nov. 3, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that management will present at two upcoming investor conferences.

BioMarin to Participate in Two Upcoming Investor Conferences

Investors were expecting better top-line numbers from the company's earnings report.

Why BioMarin Pharmaceuticals Fell 6.9% on Thursday

BioMarin Pharmaceutical's (BMRN) third-quarter 2022 earnings beat estimates, but sales slightly miss the mark.

BioMarin (BMRN) Q3 Earnings Beat, Sales Miss, Ups Voxzogo View

Biomarin Pharmaceutical, Inc. (NASDAQ:BMRN ) Q3 2022 Earnings Conference Call October 26, 2022 4:30 PM ET Company Participants Traci McCarty - VP, IR J.J. Bienaime - Chairman & CEO Jeffrey Ajer - EVP & Chief Commercial Officer Henry Fuchs - President, Worldwide Research & Development Brian Mueller - EVP, Finance & CFO Conference Call Participants Philip Nadeau - Cowen and Company Salveen Richter - Goldman Sachs Jessica Fye - JPMorgan Chase & Co. Srikripa Devarakonda - Truist Securities Paul Matteis - Stifel, Nicolaus & Company Robert Finke - Guggenheim Securities Joseph Schwartz - SVB Securities Lachlan Brown - William Blair & Company Gena Wang - Barclays Bank Joel Beatty - Robert W.

Biomarin Pharmaceutical, Inc. (BMRN) Q3 2022 Earnings Call Transcript

BioMarin (BMRN) delivered earnings and revenue surprises of 21.62% and 1.53%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?

BioMarin Pharmaceutical (BMRN) Surpasses Q3 Earnings Estimates

VOXZOGO® $48 Million Contribution in the Quarter Results in BioMarin Raising Full-year 2022 VOXZOGO Net Product Revenue Guidance to Between $140 Million and $170 Million U.S. Biologics Application for ROCTAVIAN™ Accepted by U.S. Food and Drug Administration (FDA); Prescription Drug User Fee Act (PDUFA) Target Action Date is March 31, 2023; Commercial Launch of ROCTAVIAN Underway in the European Union (EU) Following August 24, 2022 Approval Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 % Change 2022 2021 % Change Total Revenues $       505.3 $       408.7 24 % $    1,558.5 $    1,396.5 12 % Net Product Revenues Marketed by BioMarin (1) $       464.3 $       369.5 26 % $    1,425.7 $    1,245.8 14 % VIMIZIM® Net Product Revenues $       155.5 $       136.9 14 % $       511.7 $       466.8 10 % NAGLAZYME® Net Product Revenues $         99.5 $         71.2 40 % $       343.3 $       297.3 15 % PALYNZIQ® Net Product Revenues $         66.2 $         60.7 9 % $       182.7 $       173.7 5 % KUVAN Net Product Revenues $         57.0 $         67.7 (16) % $       174.0 $       217.3 (20) % VOXZOGO Net Product Revenues $         48.3 $            0.1 nm(2) $       102.3 $            0.1 nm(2) BRINEURA® Net Product Revenues $         37.8 $         32.9 15 % $       111.7 $         90.6 23 % ALDURAZYME® Net Product Revenues $         29.0 $         24.4 19 % $         90.8 $       102.5 (11) % GAAP Net Income (Loss) $          (6.7) $        (36.5) $       141.8 $          (6.2) GAAP Net Income (Loss) per Share – Basic $        (0.04) $        (0.20) $         0.77 $        (0.03) GAAP Net Income (Loss) per Share – Diluted $        (0.04) $        (0.20) $         0.75 $        (0.03) Non-GAAP Income (3) $         82.7 $         33.5 $       297.2 $       235.7 September 30, 2022 December 31, 2021 Total cash, cash equivalents & investments $               1,646.1 $               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 nine months ended September 30, 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 Third Quarter 2022 Year-over-Year Total Revenue Growth of 24% (31% Excluding KUVAN®)

BioMarin (BMRN) has an impressive earnings surprise history and currently possesses the right combination of the two key ingredients for a likely beat in its next quarterly report.

Can BioMarin (BMRN) Keep the Earnings Surprise Streak Alive?

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If approved, BioMarin's (BMRN) valoctocogene roxaparvovec will become the first gene therapy for treating hemophilia A in the United States. A decision from the FDA is due on Mar 31, 2023.

BioMarin (BMRN) Hemophilia Gene Therapy BLA Gets FDA Acceptance

If Approved, Would Be 1st Gene Therapy in U.S. for Treatment of Severe Hemophilia A PDUFA Target Action Date is March 31, 2023 SAN RAFAEL, Calif. , Oct. 12, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the U.S. Food and Drug Administration (FDA) accepted the Company's resubmission of the Biologics License Application (BLA) for its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A.

News for BioMarin Pharmaceutical Stock (BMRN)