NASDAQ:BMRN

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BioMarin Pharmaceutical said it will discontinue dosing and enrollment in Phase 2 trials of VOXZOGO for Turner syndrome, SHOX-deficiency and Aggrecan (ACAN) deficiency after several slipped capital femoral epiphysis (SCFE) events were reported in two investigator-sponsored studies.

The company noted that SCFE events were not observed in BioMarin’s own Phase 2 trials for these conditions, nor among more than 5,000 infants and children treated with VOXZOGO for achondroplasia across roughly 10,000 patient-years of safety data. No cases have also been reported in BioMarin’s clinical trials for hypochondroplasia.

Other VOXZOGO studies will continue as planned, including Phase 2 CANOPY trials in children with Noonan syndrome and in those with idiopathic short stature without ACAN deficiency, which accounts for about 95% of participants in the idiopathic short stature study.
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WS Investor 03-16-26
BioMarin Pharmaceutical Inc. announced the pricing of a major debt financing package to support its pending acquisition of Amicus Therapeutics.

The company priced an $850 million private offering of 5.500% senior unsecured notes due 2034, issued at par, with closing expected on February 12, 2026. In parallel, BioMarin completed the syndication of a new $2 billion senior secured Term Loan B facility, in addition to an existing $800 million Term Loan A facility and a planned $600 million senior secured revolving credit facility.

BioMarin plans to use the proceeds from the notes, term loans, and cash on hand to fund the Amicus acquisition and related transaction costs. The notes will be placed into escrow and are subject to mandatory redemption if the acquisition is not completed by December 19, 2026. The debt will be guaranteed by certain BioMarin subsidiaries, including Amicus following the transaction, and will include customary restrictive covenants.

Source: PRNewswire
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WS Investor 01-30-26
Veeva Systems and BioMarin Pharmaceutical have formed a long-term enterprise strategic partnership, expanding their existing relationship. The agreement is designed to help BioMarin increase speed, agility, and operational efficiency across drug development and commercialization by further leveraging Veeva’s software, data, services, and consulting capabilities, with the aim of bringing innovative therapies to patients more quickly.

Source: Veeva Systems, PR Newswire
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WS Investor 01-08-26
BioMarin Posts Strong Q2 2025 Results, Raises Full-Year Guidance

BioMarin Pharmaceutical (NASDAQ: BMRN) reported Q2 2025 revenue of $825 million, up 16% year-over-year, and GAAP EPS of $1.23, more than double last year’s figure. Non-GAAP EPS was $1.44, up 50%. The company also raised full-year guidance for revenue, operating margin, and EPS.

Key Highlights:
• VOXZOGO revenue rose 20% Y/Y, driven by strong demand globally and new patients, particularly in the U.S.
• Enzyme therapies revenue grew 15% Y/Y, with strong performances from PALYNZIQ (+20%) and VIMIZIM (+21%).
• GAAP operating margin expanded to 33.5% (+16.6 pts Y/Y); non-GAAP margin at 39.9% (+8.7 pts Y/Y)
• Net income: $241 million GAAP, up 125% Y/Y; Non-GAAP income: $282 million, up 49% Y/Y
• Operating cash flow rose 55% Y/Y to $185 million; cash & investments totaled $1.9 billion
Pipeline and Strategic Developments:
• BMN 333 (long-acting CNP) showed strong Phase 1 results; pivotal pediatric study to begin 1H 2026
• Inozyme acquisition completed July 1, adding BMN 401 (enzyme therapy for ENPP1 Deficiency); data expected 1H 2026
• VOXZOGO expanding into additional indications (e.g., hypochondroplasia, Noonan, Turner syndromes)
• BMN 351 (Duchenne) and BMN 349 (AATD) progressing toward key milestones
• BMN 390 for PKU discontinued

CEO Alexander Hardy expressed confidence in BioMarin’s ability to deliver continued growth, innovation, and shareholder value, noting solid execution across business operations and a strengthened pipeline heading into 2026.
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European Investor 08-05-25
BioMarin to Acquire Inozyme for $4.00/Share in All-Cash Deal

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced it has entered into a definitive merger agreement to acquire Inozyme Pharma, Inc. for $4.00 per share in cash, valuing the deal at approximately $140 million. The acquisition will occur via a tender offer, followed by a merger, and is expected to close in the coming months.

BioMarin will initiate the tender offer by June 2, 2025, and it will remain open for 20 business days. Closing is subject to customary conditions, including a majority of shares tendered and regulatory approvals.

If successful, Inozyme will become a wholly-owned subsidiary of BioMarin. In connection with the deal, Inozyme’s board unanimously approved the transaction and recommended shareholders tender their shares.

As part of the agreement, certain Inozyme shareholders holding 11.2% of shares have already committed to tendering. A breakup fee of $8.7 million will be payable to BioMarin if Inozyme terminates the deal for a superior offer.

BioMarin sees Inozyme’s lead asset, INZ-701, as a strong strategic fit, with the potential to become the first approved therapy for ENPP1 Deficiency. Phase 3 pediatric trial data is expected soon, and approval could follow in 2027.
This acquisition expands BioMarin’s enzyme therapy portfolio and supports its external innovation strategy.
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Global Finance News 05-18-25
BioMarin Pharmaceutical Inc. reported strong fourth-quarter and full-year 2024 results, driven by significant revenue growth, operational transformation, and advancements in its pipeline. Fourth-quarter revenue reached $747 million, a 16% increase year-over-year, while full-year revenue totaled $2.85 billion, up 18% from 2023. Growth was led by the continued expansion of VOXZOGO, which saw a 56% increase in revenue for the year, as well as steady gains in BioMarin’s enzyme therapies.

The company reported a fourth-quarter GAAP net income of $125 million, up $105 million from the prior year, and a non-GAAP income of $180 million. Full-year GAAP operating margin improved to 17%, and diluted EPS increased 154% to $2.21. BioMarin also continued executing its $500 million cost transformation program, with full benefits expected by 2026.

Pipeline advancements included the initiation of clinical trials for BMN 351 for Duchenne muscular dystrophy and BMN 333 for skeletal conditions, along with progress in expanding VOXZOGO's indications through the CANOPY program. The company also expects Phase 3 results for PALYNZIQ in adolescent phenylketonuria patients by mid-2025, potentially leading to regulatory submissions.

Looking ahead, BioMarin expects 10% revenue growth in 2025, with VOXZOGO’s global expansion and enzyme therapies as key drivers. The company remains on track to reach $4 billion in revenue by 2027, with a targeted 40% non-GAAP operating margin and over $1.25 billion in annual operating cash flow by that time.
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Global Finance News 02-20-25