Biomarin Pharmaceutical Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 4 May 2026: press release. Guidance figures: 2 raised, 1 lowered, 4 new, 3 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Revenue rose to $766 million: Total revenues were $766 million, up $21 million. Management attributed the rise to timing of government orders outside the U.S. and higher Enzyme Therapies demand, partly offset by lower ROCTAVIAN revenue. Source
• GAAP net income fell 43%: GAAP net income was $106 million, against $186 million, and GAAP diluted EPS was $0.54, against $0.95. Management tied the decline to higher SG&A, a $31 million charge and higher R&D. Source
• Children treated with VOXZOGO up 20%: The number of children treated with VOXZOGO rose more than 20% year over year, with new patients starting therapy across all regions. Source
• BMN 333 study enrolling first patient: The first patient enrolled in April in the registration-enabling Phase 2/3 study of BMN 333, a long-acting CNP for achondroplasia. Source
• NAGLAZYME manufacturing charge of $31 million: Cost of sales rose mainly on a $31 million charge for an unsuccessful process qualification campaign to expand NAGLAZYME manufacturing. It reduced EPS by about $0.12 year over year. Source
• SG&A rose on pre-close and corporate costs: SG&A rose to $258 million from $206 million, reflecting Amicus pre-close costs, corporate initiatives, and higher sales and marketing spend on VOXZOGO, PALYNZIQ and VIMIZIM. Source
• Amicus closed, adding two therapies: The Amicus acquisition is complete, adding GALAFOLD for Fabry disease and POMBILITI + OPFOLDA for Pompe disease to the portfolio. Post-close contributions began April 27, 2026. Source
• About $3.7 billion of debt secured: The company secured about $3.7 billion of non-convertible debt in the first quarter to support the Amicus acquisition, at favorable pricing across the capital structure. Source

“With the acquisition of Amicus Therapeutics complete, the addition of GALAFOLD and POMBILITI + OPFOLDA to our commercial portfolio allows us to reach patients with Fabry and Pompe diseases and meaningfully strengthens and accelerates our near-to-mid-term growth rates,”

Alexander Hardy, President and Chief Executive Officer of BioMarin

Guidance

What changed from last quarter

• Guidance raised: 2026 Total Revenues guidance raised to $3.825 billion to $3.925 billion from $3.325 billion to $3.425 billion. Source
• Guidance raised: 2026 Enzyme Therapies revenue guidance raised to $2.725 billion to $2.775 billion from $2.225 billion to $2.275 billion. Source
• Guidance lowered: 2026 Non-GAAP Diluted EPS guidance lowered to $4.85 to $5.05 from $4.95 to $5.15. Source
• New guidance: Q2 2026 Non-GAAP Diluted EPS expected to be modestly higher than Q1. Source
• New guidance: About two-thirds of 2026 Non-GAAP Diluted EPS expected in the second half. Source
• New: Amicus acquisition completed, with post-close contributions from April 27, 2026. The February release had expected the close in Q2 2026. Source
• New: First patient enrolled in April in the registration-enabling Phase 2/3 study of BMN 333. The February release planned to initiate it in 1H 2026. Source
• New: U.S. sNDA for full approval of VOXZOGO in achondroplasia submitted in April. The February release planned the submission for Q2 2026. Source

Results and growth drivers

• Revenue rose to $766 million: Total revenues were $766 million, up $21 million. Management attributed the rise to timing of government orders outside the U.S. and higher Enzyme Therapies demand, partly offset by lower ROCTAVIAN revenue. Source
• GAAP net income fell 43%: GAAP net income was $106 million, against $186 million, and GAAP diluted EPS was $0.54, against $0.95. Management tied the decline to higher SG&A, a $31 million charge and higher R&D. Source
• Non-GAAP income fell 33%: Non-GAAP income was $149 million, against $221 million, and non-GAAP diluted EPS was $0.76, against $1.13. The company attributed the decline to the same factors as the GAAP decline. Source

Enzyme Therapies and VOXZOGO

• Enzyme Therapies grew 6%: Enzyme Therapies revenue was $514 million, up 6%, driven by VIMIZIM, NAGLAZYME and BRINEURA. ALDURAZYME fell 24% and PALYNZIQ fell 3% year over year. Source
• PALYNZIQ enrollments rose after label: Underlying PALYNZIQ demand rose through more enrollments and new starts in patients under 18 after the February label expansion. Source
• Children treated with VOXZOGO up 20%: The number of children treated with VOXZOGO rose more than 20% year over year, with new patients starting therapy across all regions. Source
• ROCTAVIAN revenue fell after withdrawal: ROCTAVIAN revenue fell 73% to $3 million after its voluntary withdrawal from the market. KUVAN revenue fell 4% to $24 million. Source

“We expect these high-growth assets to support our strongest financial performance yet in 2026.”

Alexander Hardy, President and Chief Executive Officer of BioMarin

Pipeline and regulatory progress

• VOXZOGO full-approval filing made: In April the company submitted a U.S. sNDA for full approval of VOXZOGO in achondroplasia. Source
• BMN 333 study enrolling first patient: The first patient enrolled in April in the registration-enabling Phase 2/3 study of BMN 333, a long-acting CNP for achondroplasia. Source
• BMN 351 early dystrophin data: Initial Phase 1/2 data for BMN 351 showed dose-dependent dystrophin increases at Week 25 in the 6 and 9 mg/kg cohorts. Creatine kinase declines suggested muscle health gains beyond Week 25. Source
• PALYNZIQ approved for adolescents: The U.S. FDA approved PALYNZIQ for adolescents aged 12 and older with PKU in February. EU approval for that group is expected in 2026. Source
• Long-term VOXZOGO height gains: In children starting VOXZOGO after age 5, mean height gains were +10.60cm after six years and +13.59cm after eight years, compared with natural history data. Source

Costs, margins and EPS

• NAGLAZYME manufacturing charge of $31 million: Cost of sales rose mainly on a $31 million charge for an unsuccessful process qualification campaign to expand NAGLAZYME manufacturing. It reduced EPS by about $0.12 year over year. Source
• SG&A rose on pre-close and corporate costs: SG&A rose to $258 million from $206 million, reflecting Amicus pre-close costs, corporate initiatives, and higher sales and marketing spend on VOXZOGO, PALYNZIQ and VIMIZIM. Source
• R&D higher on BMN 401: R&D expense was $179 million against $159 million, reflecting support for BMN 401, a late-stage program acquired in the third quarter of 2025. Source
• Amicus costs cut EPS by $0.07: Pre-close integration costs in SG&A and Amicus-related interest expense together reduced EPS by approximately $0.07. Source
• Operating margins fell year over year: GAAP operating margin was 16.9%, against 30.0%, and non-GAAP operating margin was 24.3%, against 35.7%. Source

“With a faster-growing commercial portfolio, together with two near-term Phase 3 data readouts and ongoing pipeline progress expected over the coming quarters, we are well-positioned to drive innovation, create shareholder value, and improve outcomes for patients worldwide.”

Alexander Hardy, President and Chief Executive Officer of BioMarin

Demand and patient uptake

• Patient demand drove Enzyme and VOXZOGO revenue: Management cited higher patient demand for Enzyme Therapies and new patients starting VOXZOGO across all regions as drivers of revenue growth. Source
• Large VOXZOGO orders in Q4 2025: Management said the large VOXZOGO orders in the fourth quarter of 2025 were expected and left first-quarter growth modest at 3%. Source
• PALYNZIQ revenue to rise with titration: Management expects PALYNZIQ revenue to rise over time as new adult and adolescent patients titrate up to maintenance dosing. Source

Amicus acquisition and integration

• Amicus closed, adding two therapies: The Amicus acquisition is complete, adding GALAFOLD for Fabry disease and POMBILITI + OPFOLDA for Pompe disease to the portfolio. Post-close contributions began April 27, 2026. Source
• Amicus accounted as a business combination: Amicus will be accounted for as a business combination. Intangible amortization will affect GAAP results and is excluded from non-GAAP results. Source
• Plans to leverage global scale: Management said it plans to use BioMarin's global scale to expand the potential of the acquired therapies. Source

Capital, cash and debt

• About $3.7 billion of debt secured: The company secured about $3.7 billion of non-convertible debt in the first quarter to support the Amicus acquisition, at favorable pricing across the capital structure. Source
• $850 million debt proceeds in cash flow: Q1 cash flow shows $850 million of debt proceeds and $8.7 million of debt issuance costs paid. Source
• Operating cash flow of $221 million: Operating cash flow was $221 million, up from $174 million a year earlier. Management expects continued increases to support investment in innovation and future growth. Source
• Total cash about $2 billion: Total cash was approximately $2 billion at quarter end, which management said supports sustained investment in innovation and future growth. Source
• Capital expenditure of $21 million: Purchases of property, plant and equipment were $21 million in the quarter, against $17 million a year earlier. Source

Organization and compensation

• Severance from organizational redesign: Severance charges of $8 million were recorded in SG&A under a plan to simplify organizational design and strategic initiatives. Source
• Pay tied partly to non-GAAP income: Management said executive compensation is based in part on Non-GAAP Income, which the company also uses internally to run the business. Source
• Stock-based compensation rose to $44 million: Stock-based compensation was $44 million, against $37 million, including $28 million in SG&A and $12 million in R&D. Source

Coming up, as management said on 4 May 2026

• Amicus integration update next quarter: Management plans to update its longer-term plans for the Amicus integration next quarter. Source
• BMN 401 filings and launch timing: If the BMN 401 data are supportive, regulatory submissions are anticipated in 2H 2026, with a potential first-in-disease launch in 2027. Source
• VOXZOGO hypochondroplasia filings and launch timing: If the hypochondroplasia data are supportive, regulatory submissions are anticipated in 2H 2026, with a potential first-in-class launch in 2027. Source
• SNDA acceptance notice expected: The company expects to be notified of acceptance of the VOXZOGO sNDA by Q3 2026. Source
• BMN 351 12 mg/kg data by year-end: The 12 mg/kg cohort continues to enroll, and a data update is expected by year-end 2026. Source
• BMN 333 data update in 2027: A data update from the BMN 333 registration-enabling study is expected in 2027. Source

Figures management reported

Risks management discussed

• Operational: A failed process qualification campaign for NAGLAZYME manufacturing expansion produced a $31 million charge in cost of sales. Source
• Financial: Management said guidance is subject to change as purchase accounting is finalized and integration activities are completed. Source
• Demand: More than 55% of 2026 revenue is expected in the second half, so results depend on the timing of revenue. Source
• Financial: Pre-close integration costs and Amicus-related interest expense reduced Q1 EPS by about $0.07. Source

Earlier plans management reported on

• Not stated: The February release expected the Amicus deal to close in Q2 2026. The May release reports the acquisition complete.
• Not stated: The February release placed BMN 401 Phase 3 topline data in 1H’26. The May release says the company expects to share it in the second quarter. Source
• Not stated: The February release placed hypochondroplasia Phase 3 data in 1H’26. The May release says the company expects to share it in the second quarter. Source
• Not stated: The February release planned to initiate the registration-enabling study in 1H’26. The first patient was enrolled in April. Source
• Not stated: The February release planned the U.S. sNDA for full approval in Q2 2026. The company reports the submission in April. Source

Other quarters

• Q2 FY2026 earnings call
• Q4 FY2025 earnings call
• Q3 FY2025 results
• Q2 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.