BioMarin Reports Fourth Quarter and Full Year 2024 Results; Sets Full Year 2025 Guidance
BioMarin Pharmaceutical (NASDAQ: BMRN) reported robust financial results for Q4 and FY 2024, with total revenues of $747 million for Q4 (+16% Y/Y) and $2.85 billion for the full year (+18% Y/Y). The growth was driven by strong contributions from VOXZOGO and Enzyme Therapies. GAAP net income for Q4 increased by $105 million to $125 million, while non-GAAP income rose by $85 million to $180 million. The company projects double-digit revenue and profitability growth in 2025, with total revenues expected to grow by 10% Y/Y.
Key developments include the advancement of pipeline candidates such as BMN 351 for Duchenne Muscular Dystrophy and BMN 333 for skeletal conditions, with significant clinical data expected in 2025. VOXZOGO saw a 42% increase in Q4 and 56% in FY 2024, and is on track to be available in over 60 countries by 2027.
BioMarin's full-year GAAP operating margin expanded by 9.3 percentage points to 17.0%, with a GAAP diluted EPS of $2.21 (+154% Y/Y). The company expects a non-GAAP operating margin of 40% by 2026. Operating cash flows for FY 2024 totaled $573 million, a 260% increase Y/Y, with total cash and investments at $1.7 billion. BioMarin targets over $1.25 billion in operating cash flows annually starting in 2027.
BioMarin Pharmaceutical (NASDAQ: BMRN) ha riportato risultati finanziari solidi per il quarto trimestre e l'anno fiscale 2024, con ricavi totali di 747 milioni di dollari per il Q4 (+16% rispetto all'anno precedente) e 2,85 miliardi di dollari per l'intero anno (+18% rispetto all'anno precedente). La crescita è stata sostenuta da forti contributi di VOXZOGO e Terapie Enzimatiche. L'utile netto GAAP per il Q4 è aumentato di 105 milioni di dollari, raggiungendo i 125 milioni di dollari, mentre l'utile non-GAAP è salito di 85 milioni di dollari, arrivando a 180 milioni di dollari. L'azienda prevede una crescita a doppia cifra dei ricavi e della redditività nel 2025, con ricavi totali attesi in crescita del 10% rispetto all'anno precedente.
Sviluppi chiave includono il progresso dei candidati in pipeline come BMN 351 per la Distrofia Muscolare di Duchenne e BMN 333 per condizioni scheletriche, con dati clinici significativi attesi nel 2025. VOXZOGO ha visto un aumento del 42% nel Q4 e del 56% nell'anno fiscale 2024, ed è sulla buona strada per essere disponibile in oltre 60 paesi entro il 2027.
Il margine operativo GAAP di BioMarin per l'intero anno è aumentato di 9,3 punti percentuali, raggiungendo il 17,0%, con un utile per azione diluito GAAP di 2,21 dollari (+154% rispetto all'anno precedente). L'azienda prevede un margine operativo non-GAAP del 40% entro il 2026. I flussi di cassa operativi per l'anno fiscale 2024 hanno totalizzato 573 milioni di dollari, con un aumento del 260% rispetto all'anno precedente, e un totale di liquidità e investimenti pari a 1,7 miliardi di dollari. BioMarin punta a superare i 1,25 miliardi di dollari di flussi di cassa operativi annuali a partire dal 2027.
BioMarin Pharmaceutical (NASDAQ: BMRN) reportó resultados financieros sólidos para el cuarto trimestre y el año fiscal 2024, con ingresos totales de 747 millones de dólares para el Q4 (+16% interanual) y 2.85 mil millones de dólares para el año completo (+18% interanual). El crecimiento fue impulsado por contribuciones fuertes de VOXZOGO y Terapias Enzimáticas. La ganancia neta GAAP para el Q4 aumentó en 105 millones de dólares, alcanzando los 125 millones de dólares, mientras que la ganancia no GAAP creció en 85 millones de dólares, llegando a 180 millones de dólares. La compañía proyecta un crecimiento de ingresos y rentabilidad de dos dígitos en 2025, con ingresos totales esperados en crecimiento del 10% interanual.
Los desarrollos clave incluyen el avance de candidatos en la pipeline como BMN 351 para la Distrofia Muscular de Duchenne y BMN 333 para condiciones esqueléticas, con datos clínicos significativos esperados en 2025. VOXZOGO vio un aumento del 42% en el Q4 y del 56% en el año fiscal 2024, y está en camino de estar disponible en más de 60 países para 2027.
El margen operativo GAAP de BioMarin para el año completo se expandió en 9.3 puntos porcentuales, alcanzando el 17.0%, con un EPS diluido GAAP de 2.21 dólares (+154% interanual). La compañía espera un margen operativo no GAAP del 40% para 2026. Los flujos de efectivo operativos para el año fiscal 2024 totalizaron 573 millones de dólares, un aumento del 260% interanual, con un total de efectivo e inversiones de 1.7 mil millones de dólares. BioMarin tiene como objetivo más de 1.25 mil millones de dólares en flujos de efectivo operativos anuales a partir de 2027.
BioMarin 제약 (NASDAQ: BMRN)은 2024년 4분기 및 전체 연도에 대해 강력한 재무 결과를 보고했습니다. 4분기 총 수익은 7억 4,700만 달러로 전년 대비 16% 증가했고, 전체 연도 수익은 28억 5천만 달러로 전년 대비 18% 증가했습니다. 성장은 VOXZOGO와 효소 요법의 강력한 기여에 의해 촉진되었습니다. 4분기 GAAP 순이익은 1억 5백만 달러 증가하여 1억 2천5백만 달러에 도달했으며, 비GAAP 수익은 8천5백만 달러 증가하여 1억 8천만 달러에 도달했습니다. 회사는 2025년에 수익과 수익성의 두 자릿수 성장을 예상하고 있으며, 총 수익은 전년 대비 10% 증가할 것으로 보입니다.
주요 개발 사항으로는 듀셴 근육 위축증을 위한 BMN 351 및 골격 조건을 위한 BMN 333과 같은 파이프라인 후보의 발전이 포함되며, 2025년에 중요한 임상 데이터가 기대됩니다. VOXZOGO는 4분기에 42% 증가하고 2024년 전체 연도에 56% 증가했으며, 2027년까지 60개국 이상에서 사용 가능할 예정입니다.
BioMarin의 전체 연도 GAAP 운영 마진은 9.3 포인트 증가하여 17.0%에 도달했으며, GAAP 희석 EPS는 2.21달러로 전년 대비 154% 증가했습니다. 회사는 2026년까지 비GAAP 운영 마진이 40%에 이를 것으로 예상하고 있습니다. 2024년 전체 연도의 운영 현금 흐름은 5억 7천3백만 달러로 전년 대비 260% 증가했으며, 총 현금 및 투자액은 17억 달러입니다. BioMarin은 2027년부터 연간 운영 현금 흐름이 12억 5천만 달러를 초과할 것으로 목표하고 있습니다.
BioMarin Pharmaceutical (NASDAQ: BMRN) a rapporté des résultats financiers robustes pour le quatrième trimestre et l'année fiscale 2024, avec des revenus totaux de 747 millions de dollars pour le Q4 (+16% par rapport à l'année précédente) et 2,85 milliards de dollars pour l'année entière (+18% par rapport à l'année précédente). La croissance a été soutenue par des contributions solides de VOXZOGO et des thérapies enzymatiques. Le bénéfice net GAAP pour le Q4 a augmenté de 105 millions de dollars pour atteindre 125 millions de dollars, tandis que le bénéfice non-GAAP a progressé de 85 millions de dollars pour atteindre 180 millions de dollars. L'entreprise prévoit une croissance à deux chiffres des revenus et de la rentabilité en 2025, avec des revenus totaux attendus en hausse de 10% par rapport à l'année précédente.
Les développements clés incluent l'avancement de candidats dans le pipeline comme BMN 351 pour la dystrophie musculaire de Duchenne et BMN 333 pour des conditions squelettiques, avec des données cliniques significatives attendues en 2025. VOXZOGO a connu une augmentation de 42% au Q4 et de 56% pour l'année fiscale 2024, et est en bonne voie pour être disponible dans plus de 60 pays d'ici 2027.
La marge opérationnelle GAAP de BioMarin pour l'année entière s'est élargie de 9,3 points de pourcentage pour atteindre 17,0%, avec un BPA dilué GAAP de 2,21 dollars (+154% par rapport à l'année précédente). L'entreprise prévoit une marge opérationnelle non-GAAP de 40% d'ici 2026. Les flux de trésorerie opérationnels pour l'année fiscale 2024 ont totalisé 573 millions de dollars, ce qui représente une augmentation de 260% par rapport à l'année précédente, avec un total de liquidités et d'investissements de 1,7 milliard de dollars. BioMarin vise à dépasser 1,25 milliard de dollars de flux de trésorerie opérationnels annuels à partir de 2027.
BioMarin Pharmaceutical (NASDAQ: BMRN) berichtete über robuste Finanzzahlen für das vierte Quartal und das Geschäftsjahr 2024, mit Gesamterlösen von 747 Millionen Dollar für das Q4 (+16% im Vergleich zum Vorjahr) und 2,85 Milliarden Dollar für das gesamte Jahr (+18% im Vergleich zum Vorjahr). Das Wachstum wurde durch starke Beiträge von VOXZOGO und Enzymtherapien vorangetrieben. Der GAAP-Nettoertrag für das Q4 stieg um 105 Millionen Dollar auf 125 Millionen Dollar, während der Non-GAAP-Ertrag um 85 Millionen Dollar auf 180 Millionen Dollar zunahm. Das Unternehmen prognostiziert ein zweistelliges Wachstum von Umsatz und Rentabilität im Jahr 2025, wobei die Gesamterlöse voraussichtlich um 10% im Vergleich zum Vorjahr steigen werden.
Wichtige Entwicklungen umfassen den Fortschritt von Pipeline-Kandidaten wie BMN 351 für die Duchenne-Muskeldystrophie und BMN 333 für Skelettzustände, wobei signifikante klinische Daten für 2025 erwartet werden. VOXZOGO verzeichnete im Q4 einen Anstieg von 42% und im Geschäftsjahr 2024 von 56% und wird voraussichtlich bis 2027 in über 60 Ländern verfügbar sein.
Die GAAP-Betriebsgewinnmarge von BioMarin für das gesamte Jahr erweiterte sich um 9,3 Prozentpunkte auf 17,0%, mit einem GAAP verwässerten EPS von 2,21 Dollar (+154% im Vergleich zum Vorjahr). Das Unternehmen erwartet bis 2026 eine Non-GAAP-Betriebsgewinnmarge von 40%. Die operativen Cashflows für das Geschäftsjahr 2024 beliefen sich auf insgesamt 573 Millionen Dollar, was einem Anstieg von 260% im Vergleich zum Vorjahr entspricht, bei einem Gesamtbetrag von 1,7 Milliarden Dollar an Bargeld und Investitionen. BioMarin strebt an, ab 2027 jährlich über 1,25 Milliarden Dollar an operativen Cashflows zu erzielen.
- Q4 2024 total revenues increased by 16% Y/Y to $747 million.
- FY 2024 total revenues grew by 18% Y/Y to $2.85 billion.
- GAAP net income for Q4 increased by $105 million to $125 million.
- Non-GAAP income for Q4 rose by $85 million to $180 million.
- VOXZOGO revenues grew by 42% in Q4 and 56% in FY 2024.
- Full-year GAAP operating margin expanded by 9.3 percentage points to 17.0%.
- GAAP diluted EPS increased by 154% Y/Y to $2.21.
- Operating cash flows for FY 2024 increased by 260% to $573 million.
- Total cash and investments at the end of Q4 were approximately $1.7 billion.
- Higher SG&A expenses due to increased bad debt expense.
Insights
BioMarin's Q4 and FY2024 results reveal a company executing exceptionally well on both operational and strategic fronts. The
VOXZOGO's performance is especially noteworthy, with its
The company's financial health is robust, with
Looking ahead, BioMarin's pipeline advances in multiple indications, particularly with BMN 351 for Duchenne Muscular Dystrophy and the CANOPY clinical program, provide multiple catalysts for growth. The company's cost transformation initiative targeting
Strong Execution and Operational Transformation in 2024 Delivered Record Full Year Results and Provides Momentum for Double-Digit Revenue and Profitability Growth in 2025
4Q 2024 Total Revenues of
Conference Call and Webcast Scheduled Today at 4:30 p.m. ET
"Our operational transformation and strong financial execution in 2024 is the first step in BioMarin's ambitious multiyear growth plan," said Alexander Hardy, President and Chief Executive Officer of BioMarin. "We begin 2025 ready to build on our leadership in treating genetically defined conditions and deliver breakthrough medicines to the patients we serve. This year, we expect a number of innovative pipeline candidates to advance, including BMN 351 for Duchenne Muscular Dystrophy, and BMN 333 for multiple skeletal conditions, that will yield early clinical data read-outs, as well as results from the Phase 3 PALYNZIQ® study for the treatment of adolescents with phenylketonuria between the ages of 12 and 17. We plan to submit applications to expand the age eligibility in
Mr. Hardy continued, "We expect 2025 to be another year of strong execution and growth in our Skeletal Conditions business unit, led by the continued global expansion of VOXZOGO for achondroplasia. Across our Enzyme Therapies, we are implementing new initiatives to reach an even greater number of patients around the world. In addition to this commercial performance, we intend to execute on our business development strategy as well as advance five new VOXZOGO indications within our CANOPY clinical program. In summary, we expect continued high performance as we benefit from BioMarin's revamped corporate strategy and operating model in 2025 and beyond."
Fourth Quarter Financial Highlights:
- Total Revenues for the fourth quarter of 2024 were
$747 million 16% , compared to the same period in 2023, driven by strong VOXZOGO contributions from new patient starts in all regions. In the quarter, revenues from BioMarin's Enzyme Therapies (ALDURAZYME®, BRINEURA®, NAGLAZYME®, PALYNZIQ and VIMIZIM®) increased9% compared to the fourth quarter of 2023. The increase in revenues from Enzyme Therapies was driven by a combination of increased patient demand in all regions and the timing of large government orders in certain regions outside theU.S. - GAAP Net Income increased by
$105 million $125 million - Non-GAAP Income increased by
$85 million $180 million
Fourth Quarter and Full-year 2024 Highlights and 2025 Outlook
Innovation
- Skeletal Conditions: Recently published data highlight the importance of early treatment with VOXZOGO. As published in the December 2024 issue of MED, VOXZOGO contributes to benefits beyond height, a key area of focus for caregivers and health care professionals. With three years of follow-up, VOXZOGO-treated children had statistically significant improvements in body proportionality compared with untreated children of the same age range and gender. VOXZOGO is the only treatment for achondroplasia to have demonstrated, and been published in a peer-reviewed journal, statistically significant improvement in proportionality versus an untreated control arm.
- In January 2025, new international treatment guidelines were published in the journal Nature Reviews Endocrinology recommending early screening for achondroplasia followed by VOXZOGO treatment soon after diagnosis to provide children with the maximal opportunity for clinical benefit. These guidelines are expected to provide health care professionals and families confidence in VOXZOGO as the treatment of choice when making the important decision to pursue therapy, from infancy, for children with achondroplasia.
- Also in January 2025, dosing was initiated for the first-in-human study with BMN 333, a long-acting C-type natriuretic peptide (CNP). Initial pharmacokinetic (PK) data is expected by year-end 2025, with detailed data to be presented at a scientific conference in the first half of 2026. BioMarin is encouraged by the pre-clinical profile of BMN 333 in non-human primates, where sustained 100 pM concentrations for free CNP were observed, representing an approximate 2-3 fold increase versus published data in an analogous pre-clinical model for other long-acting CNP analogs.
- During the quarter, BioMarin also advanced development across its CANOPY clinical program with VOXZOGO in hypochondroplasia, idiopathic short stature, Noonan syndrome, Turner syndrome, and SHOX deficiency. The pivotal study in hypochondroplasia is expected to complete enrollment in the first half of 2025 and remains on track to launch in 2027.
- Other Clinical Pipeline Programs: BioMarin's next generation oligonucleotide for Duchenne Muscular Dystrophy, BMN 351, is expected to report initial proof-of-concept data at a scientific congress in the second half of 2025 (including muscle dystrophin levels after 25 weeks of dosing). Results from the phase 3 study with PALYNZIQ in adolescents ages 12-17 are expected in mid-2025 to support potential submissions for age label expansions in the
U.S. andEurope in the second half of the year. With BMN 349, an oral therapeutic for Alpha-1 antitrypsin deficiency (AATD)-associated liver disease, the single-ascending dose (SAD) phase of the first-in-human study is complete and dosing in the multiple-ascending dose (MAD) phase of the study began in December 2024.
Growth
- In 2024, strong global demand drove
42% fourth quarter growth and56% full-year growth for VOXZOGO revenues, compared to the same periods in 2023. VOXZOGO's extensive safety and efficacy profile led more families to begin therapeutic intervention early to potentially improve craniofacial volume, foramen magnum area, body proportionality and quality of life, in addition to durable increases in growth velocity. As of the end of 2024, 47 countries were contributing to VOXZOGO's global revenues, and the company expects VOXZOGO to be available in more than 60 countries by 2027. With its expected growth trajectory, VOXZOGO is on track to achieve a revenue compound annual growth rate (CAGR) exceeding25% for the period 2023 - 2027. - To provide additional insight into the dynamics of VOXZOGO's ongoing global expansion, today BioMarin provided the percentage of actual total VOXZOGO revenues split between the
U.S. and the combined contributions from outside of theU.S. (OUS). In fourth quarter 2024, VOXZOGO global revenues were$208 million 26% contribution from theU.S. and a74% contribution from OUS. In the full year 2024, VOXZOGO global revenues were$735 million 24% contribution from theU.S. and a76% contribution from OUS. - In the
U.S. , the largest single market opportunity for achondroplasia, the majority of new patient starts in the quarter were for children under the age of 5 years. In 2025, launch momentum across theU.S. is expected to contribute meaningfully to the continued global expansion of VOXZOGO across all ages from infancy. - Enzyme Therapies continue to be a significant driver of growth, with revenues increasing
9% in the fourth quarter and12% for the full-year 2024, compared to the same periods in 2023. 2024 benefited from the timing of ALDURAZYME orders, resulting in40% Y/Y revenue growth in ALDURAZYME. Enzyme Therapies excluding ALDURAZYME contributed10% Y/Y growth in full year 2024. Double-digit increases in PALYNZIQ revenue throughout 2024, and solid growth from BioMarin's other enzyme treatments are expected to continue into 2025, with Enzyme Therapies on track toward its long-term growth outlook of high single-digit CAGR.
Value Commitment
- In 2024, BioMarin delivered record performance across the business. Total revenues for the full-year 2024 grew
18% . BioMarin's full-year GAAP Operating Margin of17.0% expanded 9.3 percentage points Y/Y while GAAP Diluted EPS of$2.21 154% Y/Y. Full-year Non-GAAP Operating Margin of28.6% expanded 9.2 percentage points Y/Y while Non-GAAP Diluted EPS of$3.52 69% Y/Y. These measures of profitability increased at rates faster than revenue growth, representing the company's focus on operational efficiency. - In 2025, the company will continue to implement additional components of the
$500 million 40% Non-GAAP Operating Margin in 2026. - In 2025, full year Total Revenues guidance represents
10% Y/Y growth at the mid-point, expected to be driven by VOXZOGO's continued global expansion and solid demand across Enzyme Therapies. The company is on track to deliver its previously targeted Total Revenues of approximately$4 billion 14% (3.9 percentage points) Y/Y at the mid-point of guidance and Non-GAAP Diluted EPS is expected to increase22% Y/Y at the mid-point of guidance, as a result of continued strong commercial execution and focus on operational efficiencies across the business. - The company generated operating cash flows totaling
$573 million 260% compared to full year 2023. Total cash and investments at the end of the fourth quarter were approximately$1.7 billion $1.25 billion
Financial Highlights (in millions of
| |||||||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||
2024 | 2023 | % Change | 2024 | 2023 | % Change | ||||||
Total Revenues | 16 % | 18 % | |||||||||
Net Product Revenues by Product: | |||||||||||
VOXZOGO | 42 % | 56 % | |||||||||
Enzyme Therapies: | |||||||||||
VIMIZIM | 9 % | 6 % | |||||||||
NAGLAZYME | 110 | 98 | 12 % | 480 | 420 | 14 % | |||||
PALYNZIQ | 100 | 88 | 14 % | 355 | 304 | 17 % | |||||
BRINEURA | 48 | 44 | 9 % | 169 | 162 | 4 % | |||||
ALDURAZYME | 39 | 43 | (9) % | 184 | 131 | 40 % | |||||
Total Enzyme Therapies Revenue | 9 % | 12 % | |||||||||
KUVAN | (24) % | (33) % | |||||||||
ROCTAVIAN® | 267 % | 767 % | |||||||||
GAAP Net Income | 525 % | 154 % | |||||||||
Non-GAAP Income (1) | 89 % | 69 % | |||||||||
GAAP Operating Margin % (2) | 21.6 % | 4.2 % | 17.0 % | 7.7 % | |||||||
Non-GAAP Operating Margin % (1) | 31.1 % | 17.2 % | 28.6 % | 19.4 % | |||||||
GAAP Diluted Earnings per Share (EPS) | 482 % | 154 % | |||||||||
Non-GAAP Diluted EPS (1) | 88 % | 69 % | |||||||||
December 31, | December 31, | ||
Total cash, cash equivalents & investments | $ 1,659 | $ 1,685 |
(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 | 2025 Guidance | |||||
Total Revenues (1) | to | |||||
Non-GAAP Operating Margin % (2) | 32 % | to | 33 % | |||
Non-GAAP Diluted EPS (2)(3) | 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. |
BioMarin will host a conference call and webcast to discuss fourth quarter and full-year 2024 financial results today, Wednesday, February 19, 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: 1878833 | Conference ID: 1878833 |
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 double-digit revenue and profitability growth in 2025, and the underlying drivers of those results, such as the revenue opportunity represented by treatments for Skeletal Conditions, namely VOXZOGO, the expected demand and continued growth potential of BioMarin's Enzyme Therapies portfolio, including PALYNZIQ, and the expectation regarding the full realization of the benefits of BioMarin's cost transformation program and the integration of efficiencies; plans regarding BioMarin's revamped corporate strategy and operating model in 2025 and beyond, including expected growth in the Skeletal Conditions business unit and execution of BioMarin's business development strategy, and its anticipated benefits; expectations regarding the Revenue Compound Annual Growth Rate (CAGR) of VOXZOGO and Enzyme Therapies for future periods; 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 and BMN 351, and expected early clinical data read-outs in 2025 for BMN 333 and BMN 351; (ii) expected results from Phase 3 PALYNZIQ study for the treatment of adolescents with phenylketonuria between the ages of 12 and 17 in 2025 and plans to submit applications to expand age eligibility 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; 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 Food and Drug Administration, the European Commission and other regulatory authorities concerning each of the described products and product candidates; the market for each of these products; actual sales of BioMarin's commercial products; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
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.
BIOMARIN PHARMACEUTICAL INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME Three and Twelve Months Ended December 31, 2024 and 2023 (In thousands of (Unaudited)
| |||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
REVENUES: | |||||||
Net product revenues | $ 735,634 | $ 633,148 | $ 2,809,445 | $ 2,372,538 | |||
Royalty and other revenues | 11,679 | 13,059 | 44,470 | 46,688 | |||
Total revenues | 747,313 | 646,207 | 2,853,915 | 2,419,226 | |||
OPERATING EXPENSES: | |||||||
Cost of sales | 136,139 | 137,930 | 580,235 | 532,062 | |||
Research and development | 173,509 | 206,250 | 747,184 | 746,773 | |||
Selling, general and administrative | 266,607 | 259,512 | 1,009,025 | 892,406 | |||
Intangible asset amortization | 9,651 | 15,236 | 43,257 | 62,211 | |||
Gain on sale of nonfinancial assets | — | — | (10,000) | — | |||
Total operating expenses | 585,906 | 618,928 | 2,369,701 | 2,233,452 | |||
INCOME FROM OPERATIONS | 161,407 | 27,279 | 484,214 | 185,774 | |||
Interest income | 17,680 | 18,044 | 74,883 | 58,339 | |||
Interest expense | (2,577) | (6,098) | (12,666) | (17,335) | |||
Other expense, net | (6,871) | (19,898) | (4,668) | (38,215) | |||
INCOME BEFORE INCOME TAXES | 169,639 | 19,327 | 541,763 | 188,563 | |||
Provision for (benefit from) income taxes | 44,696 | (1,048) | 114,904 | 20,918 | |||
NET INCOME | $ 124,943 | $ 20,375 | $ 426,859 | $ 167,645 | |||
EARNINGS PER SHARE, BASIC | $ 0.66 | $ 0.11 | $ 2.25 | $ 0.89 | |||
EARNINGS PER SHARE, DILUTED | $ 0.64 | $ 0.11 | $ 2.21 | $ 0.87 | |||
Weighted average common shares outstanding, basic | 190,688 | 188,479 | 190,027 | 187,834 | |||
Weighted average common shares outstanding, diluted | 196,581 | 191,838 | 196,708 | 191,595 | |||
BIOMARIN PHARMACEUTICAL INC. CONDENSED CONSOLIDATED BALANCE SHEETS December 31, 2024 and 2023 (In thousands of (Unaudited)
| |||
December 31, 2024 | December 31, 2023 ⁽¹⁾ | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 942,842 | $ 755,127 | |
Short-term investments | 194,864 | 318,683 | |
Accounts receivable, net | 660,535 | 633,704 | |
Inventory | 1,232,653 | 1,107,183 | |
Other current assets | 201,533 | 141,391 | |
Total current assets | 3,232,427 | 2,956,088 | |
Noncurrent assets: | |||
Long-term investments | 521,238 | 611,135 | |
Property, plant and equipment, net | 1,043,041 | 1,066,133 | |
Intangible assets, net | 255,278 | 294,701 | |
Goodwill | 196,199 | 196,199 | |
Deferred tax assets | 1,489,366 | 1,545,809 | |
Other assets | 251,391 | 171,538 | |
Total assets | $ 6,988,940 | $ 6,841,603 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable and accrued liabilities | $ 606,988 | $ 683,147 | |
Short-term convertible debt, net | — | 493,877 | |
Total current liabilities | 606,988 | 1,177,024 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 595,138 | 593,095 | |
Other long-term liabilities | 128,824 | 119,935 | |
Total liabilities | 1,330,950 | 1,890,054 | |
Stockholders' equity: | |||
Common stock, | 191 | 189 | |
Additional paid-in capital | 5,802,068 | 5,611,562 | |
Company common stock held by the Nonqualified Deferred Compensation Plan | (11,227) | (9,860) | |
Accumulated other comprehensive income (loss) | 61,653 | (28,788) | |
Accumulated deficit | (194,695) | (621,554) | |
Total stockholders' equity | 5,657,990 | 4,951,549 | |
Total liabilities and stockholders' equity | $ 6,988,940 | $ 6,841,603 | |
(1) | December 31, 2023 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, 2023, filed with the SEC on February 26, 2024. |
BIOMARIN PHARMACEUTICAL INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS Twelve Months Ended December 31, 2024 and 2023 (In thousands of (Unaudited)
| |||
Twelve Months Ended December 31, | |||
2024 | 2023 | ||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net income | $ 426,859 | $ 167,645 | |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 96,426 | 104,386 | |
Non-cash interest expense | 3,359 | 4,188 | |
Amortization of premium (accretion of discount) on investments | (8,345) | (9,228) | |
Stock-based compensation | 201,571 | 207,099 | |
Gain on sale of nonfinancial assets | (10,000) | — | |
Impairment of assets and other non-cash adjustments | 19,889 | 38,608 | |
Deferred income taxes | 56,096 | (44,981) | |
Unrealized foreign exchange loss (gain) | (16,753) | 28,446 | |
Other | 20,135 | (365) | |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (57,909) | (190,435) | |
Inventory | (63,530) | (157,058) | |
Other current assets | (3,778) | (50,335) | |
Other assets | (73,700) | (31,149) | |
Accounts payable and other short-term liabilities | (32,240) | 68,853 | |
Other long-term liabilities | 14,761 | 23,585 | |
Net cash provided by operating activities | 572,841 | 159,259 | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property, plant and equipment | (85,424) | (96,691) | |
Maturities and sales of investments | 633,018 | 864,863 | |
Purchases of investments | (410,250) | (868,496) | |
Proceeds from sale of nonfinancial assets | 10,000 | — | |
Purchase of intangible assets | (11,994) | (10,920) | |
Other | 1,141 | — | |
Net cash provided by (used in) investing activities | 136,491 | (111,244) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercises of awards under equity incentive plans | 49,277 | 69,353 | |
Taxes paid related to net share settlement of equity awards | (77,560) | (76,319) | |
Repayments of convertible debt | (494,987) | — | |
Payments of contingent consideration | — | (9,475) | |
Other | (3,177) | (2,286) | |
Net cash used in financing activities | (526,447) | (18,727) | |
Effect of exchange rate changes on cash | 4,830 | 1,308 | |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 187,715 | 30,596 | |
Cash and cash equivalents: | |||
Beginning of period | $ 755,127 | $ 724,531 | |
End of period | $ 942,842 | $ 755,127 | |
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) (In millions of (unaudited)
| |||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
GAAP Reported Net Income | $ 125 | $ 20 | $ 427 | $ 168 | |||
Adjustments | |||||||
Stock-based compensation expense - COS | 3 | 5 | 15 | 18 | |||
Stock-based compensation expense - R&D | 14 | 16 | 60 | 66 | |||
Stock-based compensation expense - SG&A | 34 | 34 | 127 | 124 | |||
Amortization of intangible assets | 10 | 15 | 43 | 62 | |||
Gain on sale of nonfinancial assets (2) | — | — | (10) | — | |||
Severance and restructuring costs (3) | 10 | — | 96 | (1) | |||
Asset impairments (4) | — | 14 | — | 14 | |||
Loss on investments (5) | — | 12 | 5 | 25 | |||
Income tax effect of adjustments | (16) | (21) | (76) | (70) | |||
Non-GAAP Income | $ 180 | $ 95 | $ 686 | $ 405 | |||
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
2024 | 2024 | ||||||
Dollar | Percentage | Dollar | Percentage | ||||
GAAP Change in Total Revenues | $ 101 | 16 % | $ 435 | 18 % | |||
Adjustment for unfavorable impact of foreign currency | 33 | 108 | |||||
Non-GAAP change in Total Revenues at Constant Currency | $ 134 | 21 % | $ 543 | 22 % | |||
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
R&D | SG&A | R&D | SG&A | R&D | SG&A | R&D | SG&A | ||||||||
GAAP expenses | $ 174 | $ 267 | $ 206 | $ 260 | $ 747 | $ 1,009 | $ 747 | $ 892 | |||||||
Adjustments | |||||||||||||||
Stock-based compensation expense | (14) | (34) | (16) | (34) | (60) | (127) | (66) | (124) | |||||||
Severance and restructuring costs (3) | — | (10) | — | — | — | (96) | — | — | |||||||
Asset impairments (4) | — | — | — | (14) | — | — | — | (14) | |||||||
Non-GAAP expenses | $ 159 | $ 222 | $ 190 | $ 212 | $ 688 | $ 786 | $ 681 | $ 755 | |||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||
2024 | Percent | 2023 | Percent | 2024 | Percent | 2023 | Percent | ||
GAAP Income from Operations | $ 161 | 21.6 % | $ 27 | 4.2 % | $ 484 | 17.0 % | $ 186 | 7.7 % | |
Adjustments | |||||||||
Stock-based compensation expense | 51 | 6.8 | 55 | 8.5 | 202 | 7.1 | 207 | 8.6 | |
Amortization of intangible assets | 10 | 1.3 | 15 | 2.3 | 43 | 1.5 | 62 | 2.6 | |
Gain on sale of nonfinancial assets (2) | — | — | — | — | (10) | (0.4) | — | — | |
Severance and restructuring costs (3) | 10 | 1.3 | — | — | 96 | 3.4 | (1) | — | |
Asset impairments (4) | — | — | 14 | 2.2 | — | — | 14 | 0.6 | |
Non-GAAP Income from Operations | $ 232 | 31.1 % | $ 111 | 17.2 % | $ 815 | 28.6 % | $ 469 | 19.4 % | |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
GAAP Diluted EPS | $ 0.64 | $ 0.11 | $ 2.21 | $ 0.87 | |||
Adjustments | |||||||
Stock-based compensation expense | 0.26 | 0.27 | 1.03 | 1.04 | |||
Amortization of intangible assets | 0.05 | 0.08 | 0.22 | 0.31 | |||
Gain on sale of nonfinancial assets (2) | — | — | (0.05) | — | |||
Severance and restructuring costs (3) | 0.05 | — | 0.49 | — | |||
Asset impairments (4) | — | 0.07 | — | 0.07 | |||
Loss on investments (5) | — | 0.06 | 0.03 | 0.12 | |||
Income tax effect of adjustments | (0.08) | (0.10) | (0.39) | (0.33) | |||
Non-GAAP Diluted EPS | $ 0.92 | $ 0.49 | $ 3.52 | $ 2.08 | |||
(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 portfolio strategy review and the associated organizational redesign efforts announced in the second and third quarters of 2024. These amounts also include impairments of certain right-of-use and fixed assets. |
(4) | Represents the write-off of capitalized tooling and fixed assets in SG&A associated with the company's decision to cease development of the first generation VOXZOGO pen device in the fourth quarter of 2023. |
(5) | The current period represents a downward adjustment to non-marketable equity securities recorded in Other income (expense), net in the first quarter of 2024. The prior year represents the impairment losses on an investment in non-marketable equity securities and a convertible note recorded in Other expense, net in the first and fourth quarter of 2023, respectively. |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
GAAP Weighted-Average Diluted Shares Outstanding | 196.6 | 191.8 | 196.7 | 191.6 | |||
Adjustments | |||||||
Common stock issuable under the company's convertible debt (1) | — | 8.4 | — | 8.4 | |||
Non-GAAP Weighted-Average Diluted Shares Outstanding | 196.6 | 200.2 | 196.7 | 200.0 | |||
(1) | Common stock issuable under the company's convertible debt was excluded from the computation of GAAP Weighted-Average Diluted Shares Outstanding when they were anti-dilutive. If converted, for the prior year comparative period, the company would have issued approximately 4.4 million shares under the convertible notes due in 2027 and 4 million shares under the convertible notes that matured on August 1, 2024. |
Contact: | ||
Investors: | Media: | |
Traci McCarty | Marni Kottle | |
BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
(415) 455-7558 | (650) 374-2803 |
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SOURCE BioMarin Pharmaceutical Inc.
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