BioMarin Reports Strong Second Quarter 2025 Results and Raises Full-year Guidance¹ for Total Revenues, Non-GAAP Operating Margin, and Non-GAAP Diluted EPS
BioMarin (NASDAQ:BMRN) reported strong Q2 2025 results with total revenues of $825 million, up 16% year-over-year. The company achieved GAAP EPS of $1.23 (+124% Y/Y) and Non-GAAP EPS of $1.44 (+50% Y/Y).
Key highlights include VOXZOGO revenue growth of 20% and Enzyme Therapies revenue growth of 15%. The company completed the acquisition of Inozyme in July 2025, adding BMN 401 to its portfolio. Additionally, BMN 333, their long-acting CNP for achondroplasia, showed promising results in healthy volunteer studies.
Based on strong performance, BioMarin raised its full-year 2025 guidance for Total Revenues, Non-GAAP Operating Margin, and Non-GAAP Diluted EPS. The company ended Q2 with $1.9 billion in cash and investments.
BioMarin (NASDAQ:BMRN) ha riportato solidi risultati nel secondo trimestre del 2025 con ricavi totali di 825 milioni di dollari, in crescita del 16% rispetto all'anno precedente. L'azienda ha raggiunto un EPS GAAP di 1,23 dollari (+124% su base annua) e un EPS Non-GAAP di 1,44 dollari (+50% su base annua).
I punti salienti includono una crescita del 20% dei ricavi di VOXZOGO e una crescita del 15% dei ricavi delle Terapie Enzimatiche. A luglio 2025, la società ha completato l'acquisizione di Inozyme, aggiungendo BMN 401 al proprio portafoglio. Inoltre, BMN 333, il loro CNP a lunga durata d'azione per l'acondroplasia, ha mostrato risultati promettenti negli studi su volontari sani.
Grazie alle solide performance, BioMarin ha rivisto al rialzo le previsioni per l'intero anno 2025 riguardanti i Ricavi Totali, il Margine Operativo Non-GAAP e l'EPS Diluido Non-GAAP. La società ha chiuso il secondo trimestre con 1,9 miliardi di dollari in liquidità e investimenti.
BioMarin (NASDAQ:BMRN) reportó sólidos resultados en el segundo trimestre de 2025 con ingresos totales de 825 millones de dólares, un aumento del 16% interanual. La compañía logró un EPS GAAP de 1,23 dólares (+124% interanual) y un EPS Non-GAAP de 1,44 dólares (+50% interanual).
Los aspectos destacados incluyen un crecimiento del 20% en los ingresos de VOXZOGO y un crecimiento del 15% en los ingresos de Terapias Enzimáticas. En julio de 2025, la empresa completó la adquisición de Inozyme, incorporando BMN 401 a su cartera. Además, BMN 333, su CNP de acción prolongada para acondroplasia, mostró resultados prometedores en estudios con voluntarios sanos.
Basándose en un desempeño sólido, BioMarin elevó sus previsiones para todo el año 2025 en ingresos totales, margen operativo Non-GAAP y EPS diluido Non-GAAP. La compañía terminó el segundo trimestre con 1.900 millones de dólares en efectivo e inversiones.
BioMarin (NASDAQ:BMRN)은 2025년 2분기에 총 매출 8억 2,500만 달러로 전년 대비 16% 증가한 강력한 실적을 보고했습니다. 회사는 GAAP EPS 1.23달러 (+124% 전년 대비)와 Non-GAAP EPS 1.44달러 (+50% 전년 대비)를 달성했습니다.
주요 내용으로는 VOXZOGO 매출이 20% 성장했고 효소 치료제 매출이 15% 증가했습니다. 2025년 7월에는 Inozyme 인수를 완료하여 BMN 401을 포트폴리오에 추가했습니다. 또한, 이들의 장기 작용형 CNP인 BMN 333은 정상 자원봉사자 대상 연구에서 유망한 결과를 보였습니다.
강력한 실적을 바탕으로 BioMarin은 2025년 전체 매출, Non-GAAP 영업 마진 및 Non-GAAP 희석 주당순이익에 대한 연간 가이던스를 상향 조정했습니다. 회사는 2분기 말에 19억 달러의 현금 및 투자 자산을 보유하고 있습니다.
BioMarin (NASDAQ:BMRN) a publié de solides résultats pour le deuxième trimestre 2025 avec un chiffre d'affaires total de 825 millions de dollars, en hausse de 16 % par rapport à l'année précédente. La société a réalisé un BPA GAAP de 1,23 $ (+124 % en glissement annuel) et un BPA Non-GAAP de 1,44 $ (+50 % en glissement annuel).
Les points clés incluent une croissance de 20 % des revenus de VOXZOGO et une croissance de 15 % des revenus des thérapies enzymatiques. En juillet 2025, la société a finalisé l'acquisition d'Inozyme, ajoutant BMN 401 à son portefeuille. De plus, BMN 333, leur CNP à action prolongée pour l'achondroplasie, a montré des résultats prometteurs dans des études sur des volontaires sains.
Sur la base de ces performances solides, BioMarin a relevé ses prévisions pour l'ensemble de l'année 2025 concernant le chiffre d'affaires total, la marge opérationnelle Non-GAAP et le BPA dilué Non-GAAP. La société a clôturé le deuxième trimestre avec 1,9 milliard de dollars en liquidités et investissements.
BioMarin (NASDAQ:BMRN) meldete starke Ergebnisse für das zweite Quartal 2025 mit Gesamtumsätzen von 825 Millionen US-Dollar, was einem Anstieg von 16 % im Jahresvergleich entspricht. Das Unternehmen erzielte ein GAAP-Gewinn je Aktie von 1,23 US-Dollar (+124 % J/J) und ein Non-GAAP-Gewinn je Aktie von 1,44 US-Dollar (+50 % J/J).
Zu den wichtigsten Highlights zählen ein Umsatzwachstum von 20 % bei VOXZOGO und ein Umsatzwachstum von 15 % bei Enzymtherapien. Im Juli 2025 schloss das Unternehmen die Übernahme von Inozyme ab und erweiterte damit sein Portfolio um BMN 401. Außerdem zeigte BMN 333, ihr langwirksames CNP zur Behandlung von Achondroplasie, vielversprechende Ergebnisse in Studien mit gesunden Freiwilligen.
Aufgrund der starken Leistung hob BioMarin seine Jahresprognose 2025 für Gesamtumsätze, Non-GAAP-Betriebsmarge und Non-GAAP verwässertes Ergebnis je Aktie an. Das Unternehmen beendete das zweite Quartal mit 1,9 Milliarden US-Dollar an Barmitteln und Investitionen.
- Total revenues increased 16% Y/Y to $825 million
- GAAP EPS grew 124% Y/Y to $1.23
- VOXZOGO revenue increased 20% Y/Y with presence in 51 countries
- Operating cash flows grew 55% Y/Y to $185 million
- GAAP Operating Margin expanded 16.6 percentage points Y/Y to 33.5%
- Strategic acquisition of Inozyme completed, adding BMN 401 to portfolio
- Company raised full-year 2025 guidance
- KUVAN revenue declined 7% Y/Y due to generic competition
- NAGLAZYME revenue decreased 2% Y/Y
- BMN 390 pre-clinical PKU treatment program discontinued due to immunogenicity issues
- Operating expenses expected to increase in second half of 2025
Insights
BioMarin shows strong growth with 16% revenue increase, raises guidance, and advances achondroplasia drug candidate BMN 333 toward pivotal trials.
BioMarin delivered an impressively strong Q2 2025 with
Their profitability metrics show dramatic improvement - GAAP diluted EPS of
The pipeline progress is equally compelling. BMN 333, their next-generation long-acting CNP for achondroplasia, achieved its targeted pharmacokinetic profile in healthy volunteer studies with AUC levels three times higher than other long-acting CNP candidates. This positions the company to begin pivotal Phase 2/3 studies in 1H 2026 with potential commercialization by 2030.
The recently completed Inozyme acquisition brings BMN 401, a potential first-in-disease treatment for ENPP1 Deficiency with pivotal data expected in 1H 2026 and potential launch in 2027. Their existing VOXZOGO franchise continues expansion into other indications with pivotal data in hypochondroplasia expected in 1H 2026.
Looking forward, management has raised full-year guidance for total revenues, non-GAAP operating margin, and non-GAAP diluted EPS. The consistent operational execution, expanding margins, and pipeline advancements collectively demonstrate BioMarin's transformation into a highly profitable commercial-stage biotech with multiple growth drivers across rare disease markets.
Second Quarter 2025 Total Revenues of
Second Quarter 2025 GAAP Diluted Earnings Per Share (EPS) of
Second Quarter 2025 Non-GAAP Diluted EPS of
BioMarin Completes Acquisition of Inozyme in July 2025; Pivotal Data from Lead Indication Expected 1H'26
BMN 333 Exceeds Targeted Exposures of Free C-type Natriuretic Peptide (CNP) in Healthy Volunteer Study; Pivotal Phase 2/3 Study with BMN 333 in Pediatric Achondroplasia Planned to Begin 1H'26
Conference Call and Webcast Scheduled Today at 4:30 p.m. ET
"We were very pleased with our second quarter performance across all aspects of the business, including strong growth, exciting pipeline progress, and delivery of our business development strategy," said Alexander Hardy, President and Chief Executive Officer of BioMarin.
Mr. Hardy continued, "In the quarter, global demand for BioMarin's innovative therapies resulted in double-digit year-over-year revenue growth and significant profitability expansion. In addition to these strong results, today, we are pleased to share early data for BMN 333, a potential new treatment option for children with achondroplasia. BMN 333, our long-acting CNP, achieved our targeted profile in the healthy volunteer study and is now expected to move into the pivotal study in 2026. Our goal is for BMN 333 to demonstrate superiority to VOXZOGO and set a new standard for the treatment of achondroplasia.
"We were also pleased to have delivered on our business development strategy with the acquisition of Inozyme, which closed on July 1st," Mr. Hardy added. "The acquisition strengthens our portfolio, adding a late stage enzyme replacement therapy, BMN 401, formerly INZ-701, for the treatment of ENPP1 Deficiency. In conclusion, with the first half of the year now complete, I am pleased with our progress and remain enthusiastic about our potential to deliver for patients, employees and our shareholders through the remainder of 2025 and beyond."
1Excludes the estimated impact of acquired in-process research and development (IPR&D) charges from BioMarin's acquisition of Inozyme Pharma, Inc. (Inozyme), which was completed on July 1, 2025. IPR&D charges are expected to be recorded in BioMarin's financial results in the third quarter of 2025. |
Second Quarter 2025 Financial Highlights
- Total Revenues for the second quarter of 2025 were
$825 million 16% compared to the same period in 2024, driven by strong20% year-over-year VOXZOGO revenue growth from new patients initiating therapy across all regions. In the quarter, revenues from BioMarin's Enzyme Therapies (ALDURAZYME®, BRINEURA®, NAGLAZYME®, PALYNZIQ and VIMIZIM®) increased15% compared to the second quarter of 2024, driven by a combination of increased patient demand in all regions and the timing of large government orders. The increase was partially offset by lower KUVAN® product revenues attributed to continued generic competition as a result of the loss of market exclusivity. - GAAP Net Income increased by
$134 million $241 million 125% , primarily attributed to higher gross profit driven by the factors noted above. The increase was also attributed to lower Selling, General and Administrative (SG&A) expense due to severance and restructuring costs incurred in 2024 and lower Research and Development (R&D) spend due to re-prioritization of investments associated with the company's portfolio strategy review announced in 2024. These increases were partially offset by higher tax provision primarily due to an increase in taxable income. - Non-GAAP Income increased by
$93 million $282 million 49% growth. The increase in Non-GAAP Income was primarily due to higher gross profit driven by the factors noted above. The increase was also attributed to lower R&D spend due to re-prioritization of R&D investments following the company's portfolio strategy review announced in 2024. These increases were partially offset by higher Non-GAAP SG&A spend in 2025 due to ongoing support of business initiatives.
Second Quarter 2025 Business Highlights
Innovation
- Skeletal Conditions: BioMarin announced today that Phase 1 data in its healthy volunteer study with BMN 333, BioMarin's long-acting C-type natriuretic peptide (CNP), demonstrated area-under-the-curve (AUC) pharmacokinetic (PK) levels greater than three times the levels observed in other long-acting CNP studies. No safety signals were noted. Based on these results, BioMarin is advancing plans to initiate the registration-enabling Phase 2/3 study in the first half of 2026. BMN 333 is on track for a potential 2030 launch, should data be supportive.
- In May, VOXZOGO data was presented at the Pediatric Endocrine Society (PES) Annual Meeting from the Phase 2 CANOPY clinical studies in younger children that assessed the impact of treatment on tibial bowing, an orthopedic complication and significant cause of pain in children with achondroplasia. Children who received VOXZOGO had a significant reduction in the magnitude of tibial bowing compared to children who received placebo. The study found that this improvement was sustained in children who received VOXZOGO treatment for several years. These findings further reinforce the growing body of evidence supporting VOXZOGO's therapeutic benefits, including improvements in craniofacial development, foramen magnum dimensions, body proportionality, quality of life, and durable increases in growth velocity—all while maintaining bone health and a consistent safety profile.
- During the quarter, BioMarin continued to advance its CANOPY clinical program studying VOXZOGO in additional indications, including hypochondroplasia, idiopathic short stature, Noonan syndrome, Turner syndrome, and SHOX deficiency. With VOXZOGO in hypochondroplasia, the company expects to share topline data from its pivotal study in the first half of 2026 and file submissions to global health authorities for approval in the second half of 2026, leading to a potential launch in 2027.
- Enzyme Therapies: In July 2025, BioMarin completed the acquisition of Inozyme, adding BMN 401 (formerly INZ-701), a potential first-in-disease treatment for ENPP1 Deficiency, to BioMarin's Enzyme Therapies portfolio. Initial pivotal data readout for the ENERGY 3 study in children ages 1–12 years is anticipated in the first half of 2026, with potential launch in 2027. BioMarin is committed to continue working with the patient and HCP communities to identify individuals with ENPP1 Deficiency who may benefit from treatment with BMN 401, in advance of a potential launch. BioMarin is progressing plans to advance BMN 401 for the treatment of ENPP1 Deficiency across additional age groups. The company is also evaluating BMN 401 for potential use in other indications.
- With PALYNZIQ for the treatment of adolescents between the ages of 12 and 17, BioMarin remains on track to submit applications in the second half of 2025 to expand PALYNZIQ age eligibility in
the United States andEurope , with potential approval in 2026. PALYNZIQ is the only enzyme substitute therapy for phenylketonuria (PKU) that lowers physiological blood Phe levels to within the normal range as well as allow for an unrestricted diet, regardless of patient phenotype. - Other Clinical Pipeline Programs: BMN 351, BioMarin's next generation oligonucleotide for Duchenne muscular dystrophy, and BMN 349, an oral therapeutic for alpha-1 antitrypsin deficiency (AATD)-associated liver disease, continue to advance. For BMN 351, the clinical study is progressing, and the company expects to share initial data by year-end. For BMN 349, the Phase 1 program is advancing, with the Phase 2 study expected to begin in the first half of 2026.
- During its regular evaluation of R&D programs, BioMarin determined that BMN 390, a pre-clinical candidate for the treatment of PKU, did not meet its target immunogenicity threshold for advancement. The program has been discontinued and employees working on the program have been redeployed within BioMarin. The company remains committed to developing new therapies for people with PKU, with other projects underway across the organization.
Growth
- Total VOXZOGO revenue in the second quarter increased
20% compared to the same period in 2024, driven by strong worldwide demand. As of the end of the quarter, children with achondroplasia in 51 countries around the world were being treated with VOXZOGO, representing strong progress towards the company's target of accessing more than 60 countries by 2027. - Global VOXZOGO Y/Y revenue growth in the quarter was led by
U.S. contributions, with the majority of new patient starts in the 0-4 year age group. Outside of theU.S. (OUS), Q2 revenue expansion was supported by deeper penetration in previously opened markets and incremental contributions from new country access. Increasing new patient starts, execution ofU.S. expansion initiatives, and ongoing OUS build-out are expected to drive higher VOXZOGO revenue in the second half of 2025 compared to the first half of 2025, and weighted to Q4. - Total Enzyme Therapies revenues grew
15% in the second quarter Y/Y. PALYNZIQ revenue increased20% Y/Y, and strength in the quarter was driven by greater numbers of patients titrating to daily maintenance dose and strong adherence. VIMIZIM revenue grew21% Y/Y in the quarter, driven by both ongoing patient demand and order timing. Total Enzyme Therapies revenues in the second half of 2025 are expected to remain robust, despite typical quarter-to-quarter order timing dynamics in the third and fourth quarters.
Value Commitment
- In the second quarter of 2025, BioMarin delivered expanding margins and increasing profitability. Second quarter GAAP Operating Margin of
33.5% expanded 16.6 percentage points Y/Y while GAAP Diluted EPS of$1.23 124% Y/Y. Second quarter Non-GAAP Operating Margin of39.9% expanded 8.7 percentage points Y/Y while Non-GAAP Diluted EPS of$1.44 50% Y/Y. These measures of profitability increased at rates faster than revenue growth, reflecting the company's implementation of operational efficiencies. - During the second quarter, GAAP and Non-GAAP R&D expenses were lower Y/Y, benefiting from focused R&D investment in prioritized assets following the results of last year's strategic portfolio review. GAAP SG&A decreased Y/Y due to higher 2024 restructuring expenses associated with the company's revamped operating model, and Non-GAAP SG&A increased Y/Y to support the company's ERP implementation and investment in business unit expansion initiatives. Operating expenses are expected to increase in the second half of 2025 vs. the first half of 2025 as clinical and commercial initiatives advance.
- As a result of the completed acquisition of Inozyme on July 1, 2025, BioMarin expects to account for the transaction as an asset purchase and record the impact of acquired in-process research and development (IPR&D) charges in its third quarter 2025 financial results, which are subject to BioMarin's financial statement closing procedures. The company expects to provide an update on full-year 2025 guidance items, including impact of the acquired IPR&D charges, in its third quarter 2025 earnings update.
- The company generated operating cash flows totaling
$185 million 55% compared to the same period in 2024. Total cash and investments at the end of the second quarter were approximately$1.9 billion - Today, BioMarin raised full-year 2025 guidance for Total Revenues, Non-GAAP Operating Margin, and Non-GAAP Diluted EPS. The improved guidance reflects continued growth in patient demand across the portfolio and the company's commitment to generate increasing profitability and cash flow to support reinvestment in innovation and growth. The guidance reflects the impact of tariffs that have already been enacted, and BioMarin expects that any new tariffs would have a limited impact in 2025. BioMarin has immaterial exposure to
U.S. tariffs forChina ,Mexico andCanada across its global supply chain operations and product sales.
Financial Highlights (in millions of | |||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
2025 | 2024 | % Change | 2025 | 2024 | % Change | ||||||
Total Revenues | 16 % | 15 % | |||||||||
Net Product Revenues by Product: | |||||||||||
VOXZOGO | 20 % | 29 % | |||||||||
Enzyme Therapies: | |||||||||||
VIMIZIM | 21 % | 9 % | |||||||||
NAGLAZYME | 129 | 132 | (2) % | 243 | 238 | 2 % | |||||
PALYNZIQ | 106 | 88 | 20 % | 199 | 164 | 21 % | |||||
ALDURAZYME | 56 | 39 | 44 % | 105 | 74 | 42 % | |||||
BRINEURA | 49 | 45 | 9 % | 89 | 84 | 6 % | |||||
Total Enzyme Therapies Revenue | 15 % | 12 % | |||||||||
KUVAN | (7) % | (20) % | |||||||||
ROCTAVIAN® | 29 % | 150 % | |||||||||
GAAP Net Income | 125 % | 117 % | |||||||||
Non-GAAP Income (1) | 49 % | 53 % | |||||||||
GAAP Operating Margin % (2) | 33.5 % | 16.9 % | 31.9 % | 15.4 % | |||||||
Non-GAAP Operating Margin % (1) | 39.9 % | 31.2 % | 37.9 % | 27.6 % | |||||||
GAAP Diluted Earnings per Share (EPS) | 124 % | 117 % | |||||||||
Non-GAAP Diluted EPS (1) | 50 % | 54 % | |||||||||
June 30, | December 31, | ||
Total cash, cash equivalents & investments | $ 1,941 | $ 1,659 |
(1) | Refer to Non-GAAP Information beginning on page 10 of this press release for definitions of Non-GAAP Income, Non-GAAP Operating Margin percentage and Non-GAAP Diluted EPS along with the related reconciliations to the comparable information reported under |
(2) | GAAP Operating Margin percentage is defined by the company as GAAP Income from Operations divided by Total Revenues. |
Forward-Looking Non-GAAP Financial Information
BioMarin does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the company is unable to predict with reasonable certainty the financial impact of changes resulting from its strategic portfolio and business operating model reviews; potential future asset impairments; gains and losses on investments; and other unusual gains and losses without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. As such, any reconciliations provided would imply a degree of precision that could be confusing or misleading to investors.
2025 Full-Year Financial Guidance (in millions, except % and EPS amounts)
Item | Provided on May 1, 2025 | Updated August 4, 2025 | ||||||||||
Total Revenues (1) | to | to | ||||||||||
Non-GAAP Operating Margin % (2)(4) | 32 % | to | 33 % | 33 % | to | 34 % | ||||||
Non-GAAP Diluted EPS (2)(3)(4) | to | to | ||||||||||
(1) | VOXZOGO contribution to full-year 2025 Total Revenues expected to be in the range of |
(2) | Refer to Non-GAAP Information beginning on page 10 of this press release for definitions of Non-GAAP Operating Margin and Non-GAAP Diluted EPS. |
(3) | Non-GAAP Diluted EPS guidance assumes approximately 200 million Weighted-Average Diluted Shares Outstanding. |
(4) | Excludes the estimated impact of acquired IPR&D charges from BioMarin's acquisition of Inozyme, which was completed on July 1, 2025. Accounting for the Inozyme transaction will be finalized and included in the company's third quarter financial results, which are subject to BioMarin's financial statement closing procedures. The company expects to provide an update on full-year 2025 guidance items, including impact of the acquired IPR&D charges, in its third quarter 2025 earnings update. |
While acquired IPR&D charges may be incurred upon execution of acquisitions, collaborations, licensing agreements, and other business development transactions, BioMarin does not forecast acquired IPR&D charges due to the uncertainty of the future occurrence, magnitude, and timing of these transactions in any given period. |
BioMarin will host a conference call and webcast to discuss second quarter 2025 financial results today, Monday, August 4, 2025, at 4:30 p.m. ET. This event can be accessed through this link or on the investor section of the BioMarin website at www.biomarin.com.
Replay Dial-in Number: 800-770-2030 | |
International Dial-in Number: 646-307-1963 | Replay International Dial-in Number: 609-800-9909 |
Conference ID: 6336054 | Conference ID: 6336054 |
About BioMarin
BioMarin is a global biotechnology company dedicated to translating the promise of genetic discovery into medicines that make a profound impact on the life of each patient. The
Forward-Looking Statements
This press release and the associated conference call and webcast contain forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including, without limitation, statements about: future financial performance, including the expectations of Total Revenues, Non-GAAP Operating Margin percentage, Non-GAAP Diluted EPS and Operating Cash Flow for, in certain instances, the full-year 2025 and future periods, as well as increasing growth and increasing operating expenses in the remainder of 2025, and the underlying drivers of those results, such as the revenue opportunity represented by treatments for Skeletal Conditions, namely VOXZOGO and VOXZOGO's contribution to full-year 2025 Total Revenues, the expected demand and continued growth of BioMarin's Enzyme Therapies portfolio, the anticipated benefits of BioMarin's acquisition of Inozyme Pharma, Inc. and the accounting treatment of such acquisition; the timing of orders for commercial products; BioMarin's ability to meet product demand; the timing of BioMarin's clinical development and commercial prospects, including announcements of data from clinical studies and trials; the clinical development and commercialization of BioMarin's product candidates and commercial products, including (i) expected advancements of pipeline candidates, including BMN 333, BMN 349, BMN 351 and BMN 401 (formerly INZ-701), the anticipated initial data read-out for BMN 351 by year-end, the expected Phase 2 study for BMN 349 in the first half of 2026, the anticipated initial readout for the BMN 401 ENERGY 3 study in the first quarter of 2026 and potential launch in 2027, plans to advance BMN 401 for the treatment of ENPP1 deficiency across additional age groups as well as potential use in other indications, and the expected data and data presentation for BMN 333 in the first half of 2026 and plans to initiate a registration-enabling study for BMN 333 in 2026 for a potential launch in 2030; (ii) plans to submit applications to expand PALYNZIQ age eligibility for the treatment of adolescents with phenylketonuria between the ages of 12 and 17 in the
These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: BioMarin's success in the commercialization of its commercial products; impacts of macroeconomic and other external factors on BioMarin's operations, the impact of new or increased tariffs, other trade protection measures, and escalating trade tensions; results and timing of current and planned preclinical studies and clinical trials and the release of data from those trials; BioMarin's ability to successfully manufacture its commercial products and product candidates; the content and timing of decisions by the
BioMarin®, BRINEURA®, KUVAN®, NAGLAZYME®, PALYNZIQ®, ROCTAVIAN®, VIMIZIM® and VOXZOGO® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. ALDURAZYME® is a registered trademark of BioMarin/Genzyme LLC. All other brand names and service marks, trademarks and other trade names appearing in this release are the property of their respective owners.
Contact: | ||
Investors: | Media: | |
Traci McCarty | Marni Kottle | |
BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
(415) 455-7558 | (650) 374-2803 |
BIOMARIN PHARMACEUTICAL INC. | |||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2025 | 2024 | 2025 | 2024 | ||||
REVENUES: | |||||||
Net product revenues | $ 812,982 | $ 702,129 | $ 1,547,626 | $ 1,339,944 | |||
Royalty and other revenues | 12,428 | 9,900 | 22,929 | 20,918 | |||
Total revenues | 825,410 | 712,029 | 1,570,555 | 1,360,862 | |||
OPERATING EXPENSES: | |||||||
Cost of sales | 150,090 | 130,459 | 301,648 | 255,639 | |||
Research and development | 161,308 | 183,787 | 320,039 | 388,774 | |||
Selling, general and administrative | 232,279 | 263,032 | 438,395 | 488,938 | |||
Intangible asset amortization | 4,846 | 14,299 | 9,693 | 28,597 | |||
Gain on sale of nonfinancial assets | — | — | — | (10,000) | |||
Total operating expenses | 548,523 | 591,577 | 1,069,775 | 1,151,948 | |||
INCOME FROM OPERATIONS | 276,887 | 120,452 | 500,780 | 208,914 | |||
Interest income | 18,827 | 19,785 | 37,840 | 39,150 | |||
Interest expense | (2,679) | (3,574) | (5,542) | (7,121) | |||
Other income (expense), net | 4,833 | (4,527) | 2,879 | (3,260) | |||
INCOME BEFORE INCOME TAXES | 297,868 | 132,136 | 535,957 | 237,683 | |||
Provision for income taxes | 57,336 | 24,962 | 109,739 | 41,847 | |||
NET INCOME | $ 240,532 | $ 107,174 | $ 426,218 | $ 195,836 | |||
EARNINGS PER SHARE, BASIC | $ 1.25 | $ 0.56 | $ 2.23 | $ 1.03 | |||
EARNINGS PER SHARE, DILUTED | $ 1.23 | $ 0.55 | $ 2.19 | $ 1.01 | |||
Weighted average common shares outstanding, basic | 191,907 | 190,114 | 191,440 | 189,490 | |||
Weighted average common shares outstanding, diluted | 197,091 | 200,505 | 196,643 | 200,137 | |||
BIOMARIN PHARMACEUTICAL INC. | |||
June 30, 2025 | December 31, 2024 ⁽¹⁾ | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 1,213,816 | $ 942,842 | |
Short-term investments | 218,309 | 194,864 | |
Accounts receivable, net | 855,855 | 660,535 | |
Inventory | 1,340,169 | 1,232,653 | |
Other current assets | 177,183 | 201,533 | |
Total current assets | 3,805,332 | 3,232,427 | |
Noncurrent assets: | |||
Long-term investments | 508,592 | 521,238 | |
Property, plant and equipment, net | 1,030,385 | 1,043,041 | |
Intangible assets, net | 239,620 | 255,278 | |
Goodwill | 196,199 | 196,199 | |
Deferred tax assets | 1,427,021 | 1,489,366 | |
Other assets | 249,192 | 251,391 | |
Total assets | $ 7,456,341 | $ 6,988,940 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable and accrued liabilities | $ 684,247 | $ 606,988 | |
Total current liabilities | 684,247 | 606,988 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 596,162 | 595,138 | |
Other long-term liabilities | 148,819 | 128,824 | |
Total liabilities | 1,429,228 | 1,330,950 | |
Stockholders' equity: | |||
Common stock, | 192 | 191 | |
Additional paid-in capital | 5,851,637 | 5,802,068 | |
Company common stock held by the Nonqualified Deferred Compensation Plan | (11,674) | (11,227) | |
Accumulated other comprehensive income (loss) | (44,565) | 61,653 | |
Retained earnings (accumulated deficit) | 231,523 | (194,695) | |
Total stockholders' equity | 6,027,113 | 5,657,990 | |
Total liabilities and stockholders' equity | $ 7,456,341 | $ 6,988,940 | |
(1) | December 31, 2024 balances were derived from the audited Consolidated Financial Statements included in the company's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 24, 2025. |
BIOMARIN PHARMACEUTICAL INC. | |||
Six Months Ended June 30, | |||
2025 | 2024 | ||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net income | $ 426,218 | $ 195,836 | |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 40,632 | 53,813 | |
Non-cash interest expense | 1,320 | 1,981 | |
Accretion of discount on investments | (2,717) | (4,678) | |
Stock-based compensation | 85,231 | 106,163 | |
Gain on sale of nonfinancial assets | — | (10,000) | |
Impairment of assets | 2,967 | 14,204 | |
Deferred income taxes | 61,771 | 1,537 | |
Unrealized foreign exchange gain | (5,306) | (19,958) | |
Other | (1,916) | (858) | |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (156,124) | (56,081) | |
Inventory | (72,462) | (47,409) | |
Other current assets | (15,092) | 1,615 | |
Other assets | (13,505) | (22,880) | |
Accounts payable and accrued liabilities | 3,111 | (54,261) | |
Other long-term liabilities | 5,537 | 6,709 | |
Net cash provided by operating activities | 359,665 | 165,733 | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property, plant and equipment | (33,869) | (47,431) | |
Maturities and sales of investments | 195,738 | 317,649 | |
Purchases of investments | (202,433) | (195,462) | |
Proceeds from sale of nonfinancial assets | — | 10,000 | |
Purchase of intangible assets | (266) | (8,512) | |
Net cash provided by (used in) investing activities | (40,830) | 76,244 | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercises of awards under equity incentive plans | 7,707 | 36,618 | |
Taxes paid related to net share settlement of equity awards | (51,089) | (66,739) | |
Other | — | (60) | |
Net cash used in financing activities | (43,382) | (30,181) | |
Effect of exchange rate changes on cash | (4,479) | 5,227 | |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 270,974 | 217,023 | |
Cash and cash equivalents: | |||
Beginning of period | $ 942,842 | $ 755,127 | |
End of period | $ 1,213,816 | $ 972,150 | |
Non-GAAP Information
The results presented in this press release include both GAAP information and Non-GAAP information. Non-GAAP Income is defined by the company as GAAP Net Income excluding amortization of intangible assets, stock-based compensation expense and, in certain periods, certain other specified items, as detailed below when applicable. The company also includes a Non-GAAP adjustment for the estimated tax impact of the reconciling items. Non-GAAP R&D expenses and Non-GAAP SG&A expenses are defined by the company as GAAP R&D expenses and GAAP SG&A expenses, respectively, excluding stock-based compensation expense and, in certain periods, certain other specified items, as detailed below when applicable. Non-GAAP Operating Margin percentage is defined by the company as GAAP Income from Operations, excluding amortization of intangible assets, stock-based compensation expense and, in certain periods, certain other specified items, divided by GAAP Total Revenues. Non-GAAP Diluted EPS is defined by the company as Non-GAAP Income divided by Non-GAAP Weighted-Average Diluted Shares Outstanding. Non-GAAP Weighted-Average Diluted Shares Outstanding is defined by the company as GAAP Weighted-Average Diluted Shares Outstanding, adjusted to include any common shares issuable under the company's equity plans and convertible debt in periods when they are dilutive under Non-GAAP. The company's presentation of percentage changes in total revenues at Constant Currency rates, which is computed using current period local currency sales at the prior period's foreign exchange rates, is also a Non-GAAP financial measure. This measure provides information about growth (or declines) in the company's total revenue as if foreign currency exchange rates had not changed between the prior period and the current period.
BioMarin regularly uses both GAAP and Non-GAAP results and expectations internally to assess its financial operating performance and evaluate key business decisions related to its principal business activities: the discovery, development, manufacture, marketing and sale of innovative biologic therapies. Because Non-GAAP Income, Non-GAAP R&D expenses, Non-GAAP SG&A expenses, Non-GAAP Operating Margin percentage, Non-GAAP Diluted EPS, Non-GAAP Weighted-Average Diluted Shares Outstanding and Constant Currency are important internal measurements for BioMarin, the company believes that providing this information in conjunction with BioMarin's GAAP information enhances investors' and analysts' ability to meaningfully compare the company's results from period to period and to its forward-looking guidance, and to identify operating trends in the company's principal business. BioMarin also uses Non-GAAP Income internally to understand, manage and evaluate its business and to make operating decisions, and compensation of executives is based in part on this measure.
Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for, or superior to comparable GAAP measures and should be read in conjunction with the consolidated financial information prepared in accordance with GAAP. Investors should note that the Non-GAAP information is not prepared under any comprehensive set of accounting rules or principles and does not reflect all of the amounts associated with the company's results of operations as determined in accordance with GAAP. Investors should also note that these Non-GAAP financial measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future there may be other items that the company may exclude for purposes of its Non-GAAP financial measures; likewise, the company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP financial measures. Because of the non-standardized definitions, the Non-GAAP financial measure as used by BioMarin in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
The following tables present the reconciliation of GAAP reported to Non-GAAP adjusted financial information:
Reconciliation of GAAP Reported Information to Non-GAAP Information (1) | |||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2025 | 2024 | 2025 | 2024 | ||||
GAAP Reported Net Income | $ 241 | $ 107 | $ 426 | $ 196 | |||
Adjustments | |||||||
Stock-based compensation expense - COS | 4 | 4 | 6 | 7 | |||
Stock-based compensation expense - R&D | 14 | 13 | 26 | 34 | |||
Stock-based compensation expense - SG&A | 30 | 31 | 53 | 66 | |||
Amortization of intangible assets | 5 | 14 | 10 | 29 | |||
Gain on sale of nonfinancial assets (2) | — | — | — | (10) | |||
Severance and restructuring costs (3) | — | 39 | — | 42 | |||
Loss on investments (4) | — | 5 | 3 | 5 | |||
Income tax effect of adjustments | (11) | (24) | (22) | (39) | |||
Non-GAAP Income | $ 282 | $ 189 | $ 502 | $ 329 | |||
Three Months Ended June 30, | |||||||
2025 | 2024 | ||||||
Dollar | Percentage | Dollar | Percentage | ||||
GAAP Change in Total Revenues | $ 113 | 16 % | $ 117 | 20 % | |||
Adjustment for unfavorable impact of foreign currency exchange rates on product sales denominated in currencies other than | 7 | 30 | |||||
Non-GAAP change in Total Revenues at Constant Currency | $ 120 | 17 % | $ 147 | 25 % | |||
Six Months Ended June 30, | |||||||
2025 | 2024 | ||||||
Dollar | Percentage | Dollar | Percentage | ||||
GAAP Change in Total Revenues | $ 210 | 15 % | $ 169 | 14 % | |||
Adjustment for unfavorable impact of foreign currency exchange rates on product sales denominated in currencies other than | 21 | 53 | |||||
Non-GAAP change in Total Revenues at Constant Currency | $ 231 | 17 % | $ 222 | 19 % | |||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2025 | 2024 | 2025 | 2024 | ||||||||||||
R&D | SG&A | R&D | SG&A | R&D | SG&A | R&D | SG&A | ||||||||
GAAP expenses | $ 161 | $ 232 | $ 184 | $ 263 | $ 320 | $ 438 | $ 389 | $ 489 | |||||||
Adjustments | |||||||||||||||
Stock-based compensation expense | (14) | (30) | (13) | (31) | (26) | (53) | (34) | (66) | |||||||
Severance and restructuring costs (3) | — | — | — | (39) | — | — | — | (42) | |||||||
Non-GAAP expenses | $ 147 | $ 203 | $ 171 | $ 193 | $ 294 | $ 385 | $ 355 | $ 381 | |||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
2025 | Percent | 2024 | Percent | 2025 | Percent | 2024 | Percent | ||||
GAAP Income from Operations | $ 277 | 33.5 % | $ 120 | 16.9 % | $ 501 | 31.9 % | $ 209 | 15.4 % | |||
Adjustments | |||||||||||
Stock-based compensation expense | 48 | 5.8 | 48 | 6.8 | 85 | 5.4 | 106 | 7.7 | |||
Amortization of intangible assets | 5 | 0.6 | 14 | 2.0 | 10 | 0.6 | 29 | 2.1 | |||
Gain on sale of nonfinancial assets (2) | — | — | — | — | — | — | (10) | (0.7) | |||
Severance and restructuring costs (3) | — | — | 39 | 5.5 | — | — | 42 | 3.1 | |||
Non-GAAP Income from Operations | $ 329 | 39.9 % | $ 222 | 31.2 % | $ 596 | 37.9 % | $ 376 | 27.6 % | |||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2025 | 2024 | 2025 | 2024 | ||||
GAAP Diluted EPS | $ 1.23 | $ 0.55 | $ 2.19 | $ 1.01 | |||
Adjustments | |||||||
Stock-based compensation expense | 0.24 | 0.24 | 0.43 | 0.53 | |||
Amortization of intangible assets | 0.03 | 0.07 | 0.05 | 0.14 | |||
Gain on sale of nonfinancial assets (2) | — | — | — | (0.05) | |||
Severance and restructuring costs (3) | — | 0.20 | — | 0.21 | |||
Loss on investments (4) | — | 0.02 | 0.02 | 0.02 | |||
Income tax effect of adjustments | (0.06) | (0.12) | (0.11) | (0.19) | |||
Non-GAAP Diluted EPS (5) | $ 1.44 | $ 0.96 | $ 2.57 | $ 1.67 | |||
(1) | Certain amounts may not sum or recalculate due to rounding. |
(2) | Represents a payment triggered by a third party's attainment of a regulatory approval milestone related to previously sold intangible assets. |
(3) | These amounts were included in SG&A and represent severance and restructuring costs related to the Company's 2024 corporate initiatives and the associated organizational redesign efforts. |
(4) | Represents impairment loss on non-marketable equity securities recorded in Other income (expense), net. |
(5) | Non-GAAP Weighted-Average Diluted Shares Outstanding were 197.1 million and 200.5 million shares for the three months ended June 30, 2025 and 2024, respectively, and 196.6 million and 200.1 million shares for the six months ended June 30, 2025 and 2024, respectively, which were equal to the respective GAAP Weighted-Average Diluted Shares Outstanding in the periods presented. |
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SOURCE BioMarin Pharmaceutical Inc.
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