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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Activist investor Elliott has reportedly built a $1 billion stake in BioMarin Pharmaceutical, Reuters reported Tuesday as BMRN stock rocketed.

BioMarin Surges As Activist Investor Elliott Reportedly Builds $1 Billion Stake

Activist investor Elliott Investment Management has built a stake in BioMarin Pharmaceutical and has been in discussions with the biotechnology company for months about its future, according to two people familiar with the matter.

Exclusive: Activist investor Elliott targets drugmaker BioMarin -sources

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BioMarin's (BMRN) Q3 earnings are in line with estimates but miss the mark on sales. The company lowered its 2023 guidance due to global pricing and reimbursement delays for Roctavian.

BioMarin (BMRN) Q3 Earnings in Line, Sales Miss, '23 View Cut

Biomarin Pharmaceutical, Inc. (NASDAQ:BMRN ) Q3 2023 Earnings Conference Call November 1, 2023 4:30 PM ET Company Participants Traci McCarty - Head of Investor Relations Jean-Jacques Bienaime - Chairman and Chief Executive Officer Jeffrey Ajer - Chief Commercial Officer Henry Fuchs - President, Worldwide Research and Development Brian Mueller - Chief Financial Officer Greg Guyer - Chief Technical Officer, Manufacturing and Technical Operations Conference Call Participants Salveen Richter - Goldman Sachs Geoff Meacham - Bank of America Phil Nadeau - TD Cowen Robyn Karnauskas - Truist Joseph Schwartz - Leerink Partners Chris Raymond - Piper Sandler Paul Matteis - Stifel Jessica Fye - JPMorgan Ellie Merle - UBS Operator Hello and welcome to the BioMarin Pharmaceutical Third Quarter 2023 Conference Call. All lines have been placed on meet to prevent any background noise.

Biomarin Pharmaceutical, Inc. (BMRN) Q3 2023 Earnings Call Transcript

• Full-year 2023 Total Revenues and Earnings Per Share Financial Guidance Narrowed; VOXZOGO® and ROCTAVIAN® Net Product Revenue Guidance Adjusted for Full-year 2023 • VOXZOGO Now Approved for Children without Age Restrictions in the United States and for Children Aged 4 Months and Older in Europe • ROCTAVIAN Reimbursement Network On-track to Support Global Patient Access and Treatment in 2024 and Beyond; Final German and Italian Prices Expected in 2023; Over 100 Treatment Eligible Companion Diagnostic Tests Completed Globally • For Full-year 2024, BioMarin Expects Revenues to Approach $3 Billion Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 % Change 2023 2022 % Change Total Revenues $        581.3 $        505.3 15 % $     1,773.0 $    1,558.5 14 % Total Enzyme Product Revenues (1) $        401.5 $        388.0 3 % $     1,270.4 $    1,240.2 2 % VIMIZIM® Net Product Revenues $        158.9 $        155.5 2 % $        525.6 $       511.7 3 % VOXZOGO Net Product Revenues $        123.1 $          48.3 155 % $        324.2 $       102.3 217 % NAGLAZYME® Net Product Revenues $        108.9 $          99.5 9 % $        322.0 $       343.3 (6) % PALYNZIQ® Net Product Revenues $          78.9 $          66.2 19 % $        216.1 $       182.7 18 % KUVAN® Net Product Revenues $          42.9 $          57.0 (25) % $        144.0 $       174.0 (17) % BRINEURA® Net Product Revenues $          41.0 $          37.8 8 % $        118.2 $       111.7 6 % ALDURAZYME® Net Product Revenues $          13.8 $          29.0 (52) % $          88.5 $         90.8 (3) % ROCTAVIAN Net Product Revenues $            0.8 $              — nm $            0.8 $             — nm GAAP Net Income (Loss) (2) $          40.4 $           (6.7) $        147.3 $       141.8 Non-GAAP Income (3) $          89.5 $          52.0 $        310.5 $       227.6 GAAP Diluted Earnings (Loss) per Share (EPS) $          0.21 $        (0.04) $          0.77 $         0.75 Non-GAAP Diluted EPS (4) $          0.46 $          0.27 $          1.60 $         1.20 September 30, 2023 December 31, 2022 Total cash, cash equivalents & investments $               1,673.8 $               1,625.4 (1) Enzyme Products include ALDURAZYME, BRINEURA, NAGLAZYME, PALYNZIQ, and VIMIZIM. (2) GAAP Net Income in the nine months ended September 30, 2022 included a $89.0 million 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 Strong Third Quarter 2023 Results, Including Continued Profitability, and 15% Total Revenue Growth Year Over Year

Mr. Hardy Brings More than 30 Years of Industry Experience, Most Recently as CEO of Genentech Mr. Bienaimé Served as CEO for 18 Years and as Chairman since 2015, Steering BioMarin to Profitability with Major Expansion of Commercial Portfolio Richard A.

BioMarin Announces Retirement of Jean-Jacques Bienaimé; Appoints Alexander Hardy President and Chief Executive Officer

BioMarin (BMRN) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

BioMarin Pharmaceutical (BMRN) Reports Next Week: Wall Street Expects Earnings Growth

The U.S. Food and Drug Administration (FDA) on Friday approved the expanded use of BioMarin Pharmaceutical's once-daily injection to treat children under the age of 5 with the most common form of short-limbed dwarfism.

U.S. FDA approves expanded use of BioMarin's dwarfism therapy

Expanded Indication in the U.S. Now Includes Children of all ages with Achondroplasia SAN RAFAEL, Calif. , Oct. 20, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) to increase linear growth in pediatric patients with achondroplasia with open epiphyses (growth plates).

U.S. Food and Drug Administration Approves BioMarin's VOXZOGO® (vosoritide) for Children Under 5 Years with Achondroplasia

During Q2 2023, BioMarin Pharmaceutical's revenues for the quarter has reached $595.3 million, a 12% YoY increase. The company's drug pipeline includes promising candidates for the treatment of rare diseases, such as severe hemophilia A and achondroplasia.

BioMarin: Growth Drivers Remain Intact

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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.

Why BioMarin (BMRN) Could Beat Earnings Estimates Again

SAN RAFAEL, Calif. , Oct. 17, 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, November 1, at 4:30 p.m.

BioMarin to Host Third-Quarter 2023 Financial Results Conference Call and Webcast on Wednesday, November 1, at 4:30pm ET

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Label Expansion Decisions Expected from U.S. and European Regulatory Authorities in Q4 SAN RAFAEL, Calif. , Sept. 21, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that new data on VOXZOGO® (vosoritide) in children with achondroplasia will be presented at the 61st Annual European Society for Paediatric Endocrinology (ESPE) Meeting in The Hague, Netherlands.

BioMarin to Present Data Showing Long-Term Benefit of VOXZOGO® (vosoritide) on Growth in Children with Achondroplasia at 2023 European Society for Paediatric Endocrinology (ESPE) Meeting

A final decision study on BioMarin's (BMRN) Voxzogo to treat children above four months with achondroplasia is expected before year's end.

CHMP Endorses BioMarin's (BMRN) Voxzogo for Use in Infants

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European Commission Approval Decision Expected Q4 2023 Opinion Based on Positive Results from Global Phase 2 and Ongoing Extension Study  U.S. Food and Drug Administration PDUFA Target Action Date for Supplemental New Drug Application for VOXZOGO for Children Under 5 is Oct. 21, 2023 SAN RAFAEL, Calif., Sept. 15, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization to expand the indication for VOXZOGO® (vosoritide) for injection to treat children with achondroplasia aged 4 months and older whose epiphyses (growth plates) are not closed.

BioMarin Receives Positive CHMP Opinion in Europe to Expand Use of VOXZOGO® (vosoritide) to Treat Children Aged 4 Months and Older with Achondroplasia

Live Audio Webcast to Begin at 8:00 a.m. Eastern Time SAN RAFAEL, Calif.

BioMarin to Present Innovative Pipeline at R&D Day on September 12th in New York

BioMarin Leadership and External Medical Experts to Discuss 7 Product Candidates in Clinical Development as well as ROCTAVIAN and VOXZOGO New Indication Opportunities R&D Day to be Webcast Beginning at 8:00 a.m. Eastern Time September 12 th SAN RAFAEL, Calif.

BioMarin to Present Pipeline at Upcoming R&D Day on Tuesday, September 12th

First Person Treated in Germany; Reimbursement Discussions on Track in France and Italy In the U.S., ROCTAVIAN Now Commercially Available and Hemophilia Treatment Centers Have Begun Screening Eligible Individuals SAN RAFAEL, Calif. , Aug. 30, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that an individual in Germany with severe hemophilia A was treated with ROCTAVIAN ®  (valoctocogene roxaparvovec-rvox), marking the first time that the gene therapy has been given commercially in Europe.

BioMarin Announces First Person Treated Commercially with ROCTAVIAN® (valoctocogene roxaparvovec-rvox) for Severe Hemophilia A in Europe

BioMarin's 2Q23 revenue rose 12% YoY to $595 million, with adjusted EBITDA at $135 million. Revenues of the mucopolysaccharidosis drug portfolio decreased 6% YoY, but Voxzogo's quarterly sales were $113 million, up 29% QoQ. Voxzogo and ValRox remain the biggest BMRN's revenue drivers.

BioMarin: Q2 2023 Confirmed My Bullish View

BioMarin (BMRN) beats on earnings and sales estimates in the second quarter on the back of robust demand for Voxzogo.

BioMarin (BMRN) Q2 Earnings & Sales Top, Voxzogo Drives Sales

Although the revenue and EPS for BioMarin (BMRN) give a sense of how its business performed in the quarter ended June 2023, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.

News for BioMarin Pharmaceutical Stock (BMRN)