BioMarin Announces 20% Y/Y Total Revenue Growth in the Second Quarter and Increase in Full-year 2024 Guidance
BioMarin reported a strong financial performance for Q2 2024, with total revenues reaching $712 million, a 20% increase year-over-year (Y/Y). The company also raised its full-year 2024 guidance. Key drivers include strong global demand for VOXZOGO, which saw a 73% Y/Y increase in the number of children receiving treatment, and robust performance of enzyme therapies. GAAP diluted EPS for the quarter was $0.55, a 90% Y/Y increase, while Non-GAAP diluted EPS was $0.96, up 78% Y/Y.
VOXZOGO contributions were significant, with nearly 900 new patient starts in the first half of 2024. BioMarin's enzyme therapies also showed strong growth, partially offset by lower revenues from KUVAN due to generic competition. GAAP net income for Q2 2024 increased by $51.2 million to $107.2 million. Non-GAAP income rose by $83.7 million to $188.9 million. Financial guidance for 2024 was updated to reflect these strong results.
BioMarin continued to make progress in its clinical programs and strategic priorities, including its supply chain efforts and development of new indications for VOXZOGO.
BioMarin ha riportato un forte risultato finanziario per il Q2 2024, con entrate totali che hanno raggiunto 712 milioni di dollari, un aumento del 20% rispetto all'anno precedente (Y/Y). L'azienda ha anche alzato le previsioni per l'intero anno 2024. I principali fattori trainanti includono una forte domanda globale per VOXZOGO, che ha visto un aumento del 73% nel numero di bambini sottoposti a trattamento, e un robusto andamento delle terapie enzimatiche. L'EPS diluito GAAP per il trimestre è stato di 0,55 dollari, con un incremento del 90% Y/Y, mentre l'EPS diluito Non-GAAP è stato di 0,96 dollari, con un aumento del 78% Y/Y.
Le contribuzioni di VOXZOGO sono state significative, con quasi 900 nuovi pazienti avviati nella prima metà del 2024. Le terapie enzimatiche di BioMarin hanno mostrato anche una forte crescita, parzialmente compensata da minori entrate da KUVAN a causa della concorrenza generica. Il reddito netto GAAP per il Q2 2024 è aumentato di 51,2 milioni di dollari, raggiungendo 107,2 milioni di dollari. Il reddito Non-GAAP è aumentato di 83,7 milioni di dollari, per un totale di 188,9 milioni di dollari. Le previsioni finanziarie per il 2024 sono state aggiornate per riflettere questi risultati positivi.
BioMarin ha continuato a fare progressi nei suoi programmi clinici e nelle sue priorità strategiche, comprese le iniziative nella catena di approvvigionamento e lo sviluppo di nuove indicazioni per VOXZOGO.
BioMarin reportó un sólido desempeño financiero para el Q2 2024, con ingresos totales que alcanzaron 712 millones de dólares, un aumento del 20% interanual (Y/Y). La compañía también elevó sus previsiones para todo el año 2024. Los principales impulsores incluyen una fuerte demanda global por VOXZOGO, que experimentó un aumento del 73% en el número de niños que recibieron tratamiento, y un sólido rendimiento de las terapias enzimáticas. El EPS diluido GAAP para el trimestre fue de 0,55 dólares, un incremento del 90% Y/Y, mientras que el EPS diluido No-GAAP fue de 0,96 dólares, un aumento del 78% Y/Y.
Las contribuciones de VOXZOGO fueron significativas, con casi 900 nuevos pacientes iniciados en la primera mitad de 2024. Las terapias enzimáticas de BioMarin también mostraron un fuerte crecimiento, parcialmente compensado por menores ingresos de KUVAN debido a la competencia genérica. El ingreso neto GAAP para el Q2 2024 aumentó en 51,2 millones de dólares, alcanzando 107,2 millones de dólares. El ingreso No-GAAP creció en 83,7 millones de dólares, totalizando 188,9 millones de dólares. Las previsiones financieras para 2024 se actualizaron para reflejar estos sólidos resultados.
BioMarin continuó avanzando en sus programas clínicos y prioridades estratégicas, incluyendo sus esfuerzos en la cadena de suministro y el desarrollo de nuevas indicaciones para VOXZOGO.
BioMarin은 2024년 2분기 동안 강력한 재무 실적을 보고했으며, 총 수익은 7억 1200만 달러로 전년 대비 20% 증가했습니다(Y/Y). 회사는 또한 2024년 전체 연간 가이던스를 상향 조정했습니다. 주요 원인은 VOXZOGO에 대한 전 세계적인 수요 증가로, 치료를 받는 아동의 수가 전년 대비 73% 증가하였으며, 효소 치료의 강력한 성과도 포함됩니다. 이번 분기의 GAAP 희석 주당순이익(EPS)은 0.55달러로, 전년 대비 90% 증가했고, Non-GAAP 희석 EPS는 0.96달러로 78% 증가했습니다.
VOXZOGO의 기여는 상당하여, 2024년 상반기 동안 거의 900명의 새로운 환자가 시작되었습니다. BioMarin의 효소 치료도 강력한 성장을 보였으나, KUVAN의 수익은 제네릭 경쟁으로 인해 다소 감소했습니다. 2024년 2분기 GAAP 순이익은 5120만 달러 증가하여 1억 720만 달러에 달했습니다. Non-GAAP 수익은 8370만 달러 증가하여 1억 8890만 달러에 달했습니다. 2024년 재무 가이던스는 이러한 강력한 결과를 반영하여 업데이트되었습니다.
BioMarin은 임상 프로그램 및 전략적 우선사항에서 계속 진전을 이루고 있으며, 공급망 노력 및 VOXZOGO의 새로운 적응증 개발을 포함하고 있습니다.
BioMarin a enregistré de solides performances financières pour le deuxième trimestre 2024, avec des recettes totales atteignant 712 millions de dollars, soit une augmentation de 20 % par rapport à l'année précédente (Y/Y). L'entreprise a également relevé ses prévisions pour l'année entière 2024. Les principaux moteurs comprennent une forte demande mondiale pour VOXZOGO, qui a connu une augmentation de 73 % du nombre d'enfants recevant un traitement, ainsi qu'une performance robuste des thérapies enzymatiques. Le résultat par action dilué selon les normes GAAP pour le trimestre était de 0,55 dollar, soit une augmentation de 90 % Y/Y, tandis que le résultat par action dilué non-GAAP était de 0,96 dollar, en hausse de 78 % Y/Y.
Les contributions de VOXZOGO ont été significatives, avec près de 900 nouveaux patients débutant au premier semestre 2024. Les thérapies enzymatiques de BioMarin ont également affiché une forte croissance, partiellement compensée par des revenus inférieurs provenant de KUVAN en raison de la concurrence générique. Le bénéfice net GAAP pour le deuxième trimestre 2024 a augmenté de 51,2 millions de dollars pour atteindre 107,2 millions de dollars. Le revenu non-GAAP a augmenté de 83,7 millions de dollars pour atteindre 188,9 millions de dollars. Les prévisions financières pour 2024 ont été mises à jour pour refléter ces solides résultats.
BioMarin a continué à progresser dans ses programmes cliniques et ses priorités stratégiques, y compris ses efforts en matière de chaîne d'approvisionnement et le développement de nouvelles indications pour VOXZOGO.
BioMarin meldete für das zweite Quartal 2024 eine starke finanzielle Leistung, mit Gesamtumsätzen von 712 Millionen Dollar, einem Anstieg von 20 % im Vergleich zum Vorjahr (Y/Y). Das Unternehmen hat auch die Prognose für das Gesamtjahr 2024 angehoben. Wichtige Treiber sind die starke globale Nachfrage nach VOXZOGO, die einen Anstieg von 73 % bei der Anzahl der Kinder, die behandelt werden, verzeichnete, sowie die robuste Leistung von Enzymtherapien. Der GAAP-verwässerte Gewinn je Aktie (EPS) für das Quartal lag bei 0,55 Dollar, was einem Anstieg von 90 % Y/Y entspricht, während der Non-GAAP-verwässerte EPS bei 0,96 Dollar lag, was einem Anstieg von 78 % Y/Y entspricht.
Die Beiträge von VOXZOGO waren erheblich, mit fast 900 neuen Patientenstarts im ersten Halbjahr 2024. Die Enzymtherapien von BioMarin zeigten ebenfalls starkes Wachstum, was teilweise durch geringere Einnahmen von KUVAN aufgrund von Generikakonkurrenz ausgeglichen wurde. Der GAAP-Nettoergebnis für das zweite Quartal 2024 stieg um 51,2 Millionen Dollar auf 107,2 Millionen Dollar. Das Non-GAAP-Einkommen stieg um 83,7 Millionen Dollar auf 188,9 Millionen Dollar. Die finanziellen Prognosen für 2024 wurden aktualisiert, um diese starken Ergebnisse widerzuspiegeln.
BioMarin machte weiterhin Fortschritte in seinen klinischen Programmen und strategischen Prioritäten, einschließlich seiner Anstrengungen in der Lieferkette und der Entwicklung neuer Indikationen für VOXZOGO.
- Total revenues for Q2 2024 increased by 20% Y/Y to $712 million.
- GAAP diluted EPS for Q2 2024 increased by 90% Y/Y to $0.55.
- Non-GAAP diluted EPS for Q2 2024 rose by 78% Y/Y to $0.96.
- Strong demand for VOXZOGO with a 73% Y/Y increase in the number of children receiving treatment.
- Significant contributions from enzyme therapies, with a 15% Y/Y growth.
- Increased full-year 2024 financial guidance.
- Lower KUVAN product revenues due to continued generic competition.
- Higher SG&A expenses primarily related to severance and restructuring costs.
- Higher R&D expenses due to expansion into new VOXZOGO indications.
BioMarin's Q2 2024 results demonstrate strong financial performance and growth. Key highlights include:
- Total revenues of
$712 million , up20% year-over-year - GAAP diluted EPS of
$0.55 , up90% year-over-year - Non-GAAP diluted EPS of
$0.96 , up78% year-over-year
The impressive growth was primarily driven by VOXZOGO, which saw a
BioMarin's Q2 results highlight the growing acceptance and efficacy of VOXZOGO in treating achondroplasia. The
BioMarin's Q2 results reveal strong market positioning and growth potential, particularly for VOXZOGO. The drug's rapid adoption, especially among younger patients in the U.S., suggests a growing market awareness and acceptance of early intervention for achondroplasia. The expansion into 44 countries indicates successful global market penetration. The company's pipeline strategy, focusing on additional growth-related conditions, could significantly expand VOXZOGO's market potential. However, ROCTAVIAN's slow uptake and the decision to focus on only three countries highlight challenges in the gene therapy market. The discontinuation of BMN 293 reflects a strategic shift towards more promising assets, potentially improving long-term market competitiveness. BioMarin's ability to secure ample VOXZOGO supply amid growing demand demonstrates effective supply chain management, important for maintaining market leadership in this rapidly growing segment.
Second Quarter 2024 Total Revenues of
Second Quarter 2024 GAAP Diluted EPS of
Second Quarter 2024 Non-GAAP Diluted Earnings per Share (EPS) of
Strong VOXZOGO® Demand in the Quarter Resulted in
Conference Call and Webcast Scheduled Today at 4:30 p.m. ET
"Strong execution across our business resulted in record double-digit revenue growth in the second quarter and first half of 2024. These top-line results, along with a focus on operational efficiency, resulted in a
Mr. Hardy added, "During the quarter, global demand for VOXZOGO continued to increase as more families sought treatment with the only approved and genetically-targeted medicine for achondroplasia. Approximately 3,500 children were receiving VOXZOGO by the end of the second quarter, with more than half of new treatment starts in
Financial Highlights:
- Total Revenues for the second quarter of 2024 were
$712.0 million 20% , compared to the same period in 2023, driven by strong VOXZOGO contributions from new patient starts, high compliance rates, and customer stock levels normalizing facilitated by ample supply. In the quarter, demand across BioMarin's enzyme therapies (VIMIZIM®, NAGLAZYME®, ALDURAZYME®, BRINEURA® and PALYNZIQ®) drove15% growth compared to the second quarter of 2023. This increase was partially driven by NAGLAZYME product revenues due to the timing of large government orders in certain regions outsidethe United States and higher PALYNZIQ revenues inthe United States driven by new patient starts. Partially offsetting the increase were lower KUVAN® product revenues attributed to continued generic competition as a result of the loss of market exclusivity. - GAAP Net Income increased by
$51.2 million $107.2 million - Non-GAAP Income increased by
$83.7 million $188.9 million
2Q Update on 2024 Strategic Priorities
In the second quarter, BioMarin continued to deliver on its four strategic priorities, first outlined in January, and focused on value creation through accelerating growth, optimizing efficiencies and driving operational excellence.
Accelerate and maximize the VOXZOGO opportunity
- During the second quarter, the number of children with achondroplasia benefiting from VOXZOGO treatment increased to approximately 3,500 across 44 countries. Global access to VOXZOGO from infancy had a significant impact on uptake as families pursued maximum therapeutic benefit by starting treatment early.
- In the
U.S. , the largest potential market, the majority of new patient starts in the quarter were for children under the age of 5 years. VOXZOGO's extensive safety and efficacy profile led more families to begin therapeutic intervention early to potentially impact greater improvements in craniofacial growth, foramen magnum compression, body proportionality and quality of life, in addition to durable increases in growth velocity. - During the quarter, new, multi-year data demonstrating that treating achondroplasia with VOXZOGO improved health related quality of life and proportionality, which are important benefits, beyond height, for affected children and their families. These results were presented at the Pediatric Endocrine Society (PES) annual meeting (press release), and the 2024 International Conference on Children's Bone Health (ICCBH) (press release). In addition, positive results with VOXZOGO from Phase 2 in children with Noonan Syndrome, idiopathic short stature and other growth-related conditions were presented.
- At PES on May 4, results from a Phase 3 extension study in children with achondroplasia who began VOXZOGO treatment at 10 years of age or older, demonstrated that meaningful height gains were observed despite the age of participants at treatment initiation. Results from a Phase 2 extension study showed that VOXZOGO maintained positive effects on linear growth over 4 years in children who began treatment under age five. Results from an investigator-sponsored Phase 2 in children 3-11 years old with several genetic growth-related conditions demonstrated marked improvement in annualized growth velocity and height standard deviation across all conditions studied.
- At ICCBH on June 17, a new investigator-led study showed VOXZOGO significantly increased bone length while maintaining bone strength through 5 years of observation in children with achondroplasia, an essential functional outcome for children receiving multi-year treatment. Phase 2 and Phase 3 data on VOXZOGO demonstrated durable safety and efficacy, and improvements on proportionality and health-related quality of life in children with achondroplasia.
- At PES on May 4, results from a Phase 3 extension study in children with achondroplasia who began VOXZOGO treatment at 10 years of age or older, demonstrated that meaningful height gains were observed despite the age of participants at treatment initiation. Results from a Phase 2 extension study showed that VOXZOGO maintained positive effects on linear growth over 4 years in children who began treatment under age five. Results from an investigator-sponsored Phase 2 in children 3-11 years old with several genetic growth-related conditions demonstrated marked improvement in annualized growth velocity and height standard deviation across all conditions studied.
- Building on its leadership in achondroplasia, BioMarin's clinical programs across multiple new growth-related conditions are underway. The pivotal study with VOXZOGO for hypochondroplasia is actively enrolling. Clinical programs in idiopathic short stature, Noonan Syndrome, Turner Syndrome and SHOX deficiency are all on track for enrollment later this year.
- During the second quarter, through extensive supply chain efforts, BioMarin secured ample VOXZOGO supply to support patient demand worldwide. As of the end of the quarter, the company was able to provide VOXZOGO supply to new patients immediately, as identified. Additionally, the company has ample supply capacity to support all ongoing VOXZOGO clinical programs in hypochondroplasia, idiopathic short stature, Noonan Syndrome, Turner Syndrome and SHOX deficiency, as well as expected commercial demand.
Establish ROCTAVIAN® opportunity
- Today, the company announced its updated strategy for ROCTAVIAN. The strategy will enable ROCTAVIAN to contribute to BioMarin's long-term profitability. By focusing commercial, research and manufacturing programs in three prioritized countries, including
the United States ,Germany andItaly , BioMarin anticipates reducing annual direct ROCTAVIAN expenses to approximately$60 million $60 million - During the quarter, BioMarin treated 3 patients in the
U.S. and 2 inItaly , generating$7 million U.S. ,Germany andItaly .
Focus R&D on the most promising assets
- During the quarter, BioMarin progressed development of its prioritized pipeline products: BMN 351, BMN 349, and BMN 333. BMN 351, BioMarin's next generation oligonucleotide for Duchenne Muscular Dystrophy, has completed enrollment of the first dose cohort, with data expected by year-end. With BMN 349, a potential best-in-class, oral therapeutic for Alpha-1 antitrypsin deficiency (AATD)-associated liver disease, the company will begin enrolling its first-in-human study with healthy volunteers later this year. BMN 333, a long-acting C-type natriuretic peptide (CNP) for multiple growth disorders, is completing IND-enabling activities and is expected to enter the clinic in early 2025.
- During the quarter, the company chose to discontinue development of BMN 293, a gene therapy for hypertrophic cardiomyopathy. Applying its focused approach to investing in only those assets that have the highest potential impact for patients, the time and resources anticipated to bring BMN 293 through development and to market no longer met BioMarin's high bar for advancement.
Accelerate EPS growth and expand margins
- Sustained strong performance in the second quarter highlighted BioMarin's ongoing execution of its financial strategy to drive year-over-year Non-GAAP Operating Margin expansion and Non-GAAP EPS growth faster than revenues.
- The company raised full-year 2024 guidance for Total Revenues, Non-GAAP Operating Margin, and Non-GAAP Diluted EPS. The improved guidance reflects the underlying strength of enzyme products and continued high demand for VOXZOGO, along with BioMarin's commitment to accelerate profitability while continuing to invest in innovation. BioMarin's updated full-year 2024 guidance does not reflect the impact of potential additional future business decisions that may result from its ongoing strategic business review.
Investor Day to be held Wednesday, September 4th. Event details will be available later in August.
Financial Highlights (in millions of | |||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
2024 | 2023 | % Change | 2024 | 2023 | % Change | ||||||
Total Revenues | 20 % | 14 % | |||||||||
Net Product Revenues by Product: | |||||||||||
VOXZOGO | 62 % | 67 % | |||||||||
VIMIZIM | 0 % | 1 % | |||||||||
NAGLAZYME | 47 % | 12 % | |||||||||
PALYNZIQ | 18 % | 20 % | |||||||||
BRINEURA | 19 % | 9 % | |||||||||
ALDURAZYME | (4) % | (1) % | |||||||||
KUVAN | (43) % | (36) % | |||||||||
ROCTAVIAN | $— | nm | $— | nm | |||||||
GAAP Net Income | 91 % | 83 % | |||||||||
Non-GAAP Income (1) | 80 % | 49 % | |||||||||
GAAP Operating Margin %(2) | 16.9 % | 11.0 % | 15.4 % | 10.7 % | |||||||
Non-GAAP Operating Margin %(2) | 31.2 % | 21.7 % | 27.6 % | 22.1 % | |||||||
GAAP Diluted Earnings per Share (EPS) | 90 % | 80 % | |||||||||
Non-GAAP Diluted EPS (3) | 78 % | 46 % | |||||||||
June 30, | December 31, | ||
Total cash, cash equivalents & investments | $ 1,781.4 | $ 1,684.9 |
(1) | Non-GAAP Income is defined by the company as reported GAAP Net Income, excluding amortization of intangible assets, stock-based compensation expense and, in certain periods, certain other specified items. The company also includes a Non-GAAP adjustment for the estimated income tax impact of reconciling items. Refer to Non-GAAP Information beginning on page 10 of this press release for a complete discussion of the company's Non-GAAP financial information and 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. 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 specified items divided by Total Revenues. |
(3) | Non-GAAP Diluted EPS is defined by the company as Non-GAAP Income divided by Non-GAAP diluted weighted-average 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. |
nm | Not meaningful |
2024 Full-Year Financial Guidance (in millions, except % and EPS amounts) (Updated)
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.
Item | Provided April 24, 2024 | Updated August 5, 2024 | ||||||||||
Total Revenues | to | to | ||||||||||
Non-GAAP Operating Margin % (1) | 24 % | to | 25 % | 26 % | to | 27 % | ||||||
Non-GAAP Diluted EPS (1)(2) | to | to | ||||||||||
(1) | 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. |
(2) | Non-GAAP Diluted EPS guidance assumes approximately 200 million weighted-average diluted shares outstanding. |
BioMarin will host a conference call and webcast to discuss second quarter 2024 financial results today, Monday, August 5, 2024, 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: 646-968-2525 | Replay International Dial-in Number: 609-800-9909 |
No Conference ID: 1816377 | Conference ID: 1816377 |
About BioMarin
Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of genetic conditions. BioMarin's robust research and development capabilities have resulted in multiple innovative commercial therapies for patients with rare genetic disorders. The company's distinctive approach to drug discovery has produced a diverse pipeline of commercial, clinical, and pre-clinical candidates that address a significant unmet medical need, have well-understood biology, and provide an opportunity to be first-to-market or offer a substantial benefit over existing treatment options. For additional information, please visit www.biomarin.com.
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, and Non-GAAP Diluted EPS for the full-year 2024 and the underlying drivers of those results; BioMarin's new corporate strategy, including the timing of the completion and announcement; BioMarin's ability to accelerate the VOXZOGO opportunity; the anticipated benefits from its ongoing strategic review and the associated organizational redesign efforts; BioMarin's updated strategy for ROCTAVIAN and its anticipated benefits, including BioMarin's expectations regarding reduction of annual direct ROCTAVIAN expenses beginning in 2025 and ROCTAVIAN being profitable by the end of 2025; 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) the potential to leverage VOXZOGO in conditions beyond achondroplasia, such as hypochondroplasia, idiopathic short stature, Noonan Syndrome, Turner Syndrome, SHOX deficiency and other genetic short stature pathway conditions, (ii) the expected expansion of VOXZOGO 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 March 31, 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.
Contact: | ||
Investors: | Media: | |
Traci McCarty | Marni Kottle | |
BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
(415) 455-7558 | (650) 374-2803 |
BIOMARIN PHARMACEUTICAL INC. | |||||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME | |||||||
Three and Six Months Ended June 30, 2024 and 2023 | |||||||
(In thousands of | |||||||
(Unaudited) | |||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
REVENUES: | |||||||
Net product revenues | $ 702,129 | $ 584,698 | $ 1,339,944 | $ 1,171,124 | |||
Royalty and other revenues | 9,900 | 10,577 | 20,918 | 20,566 | |||
Total revenues | 712,029 | 595,275 | 1,360,862 | 1,191,690 | |||
OPERATING EXPENSES: | |||||||
Cost of sales | 130,459 | 130,619 | 255,639 | 266,091 | |||
Research and development | 183,787 | 177,363 | 388,774 | 349,209 | |||
Selling, general and administrative | 263,032 | 206,103 | 488,938 | 417,126 | |||
Intangible asset amortization | 14,299 | 15,624 | 28,597 | 31,294 | |||
Gain on sale of nonfinancial assets | — | — | (10,000) | — | |||
Total operating expenses | 591,577 | 529,709 | 1,151,948 | 1,063,720 | |||
INCOME FROM OPERATIONS | 120,452 | 65,566 | 208,914 | 127,970 | |||
Interest income | 19,785 | 12,612 | 39,150 | 24,555 | |||
Interest expense | (3,574) | (3,755) | (7,121) | (7,458) | |||
Other expense, net | (4,527) | (3,613) | (3,260) | (17,500) | |||
INCOME BEFORE INCOME TAXES | 132,136 | 70,810 | 237,683 | 127,567 | |||
Provision for income taxes | 24,962 | 14,770 | 41,847 | 20,675 | |||
NET INCOME | $ 107,174 | $ 56,040 | $ 195,836 | $ 106,892 | |||
EARNINGS PER SHARE, BASIC | $ 0.56 | $ 0.30 | $ 1.03 | $ 0.57 | |||
EARNINGS PER SHARE, DILUTED | $ 0.55 | $ 0.29 | $ 1.01 | $ 0.56 | |||
Weighted average common shares outstanding, basic | 190,114 | 187,948 | 189,490 | 187,311 | |||
Weighted average common shares outstanding, diluted | 200,505 | 194,998 | 200,137 | 194,756 | |||
BIOMARIN PHARMACEUTICAL INC. | |||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||
June 30, 2024 and December 31, 2023 | |||
(In thousands of | |||
June 30, 2024 | December 31, 2023 ⁽¹⁾ | ||
ASSETS | (unaudited) | ||
Current assets: | |||
Cash and cash equivalents | $ 972,150 | $ 755,127 | |
Short-term investments | 252,201 | 318,683 | |
Accounts receivable, net | 691,232 | 633,704 | |
Inventory | 1,183,621 | 1,107,183 | |
Other current assets | 160,426 | 141,391 | |
Total current assets | 3,259,630 | 2,956,088 | |
Noncurrent assets: | |||
Long-term investments | 557,083 | 611,135 | |
Property, plant and equipment, net | 1,052,898 | 1,066,133 | |
Intangible assets, net | 265,533 | 294,701 | |
Goodwill | 196,199 | 196,199 | |
Deferred tax assets | 1,545,006 | 1,545,809 | |
Other assets | 190,772 | 171,538 | |
Total assets | $ 7,067,121 | $ 6,841,603 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable and accrued liabilities | $ 572,500 | $ 683,147 | |
Short-term convertible debt, net | 494,837 | 493,877 | |
Total current liabilities | 1,067,337 | 1,177,024 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 594,116 | 593,095 | |
Other long-term liabilities | 119,369 | 119,935 | |
Total liabilities | 1,780,822 | 1,890,054 | |
Stockholders' equity: | |||
Common stock, | 190 | 189 | |
Additional paid-in capital | 5,696,701 | 5,611,562 | |
Company common stock held by the Nonqualified Deferred Compensation Plan | (11,673) | (9,860) | |
Accumulated other comprehensive income (loss) | 26,799 | (28,788) | |
Accumulated deficit | (425,718) | (621,554) | |
Total stockholders' equity | 5,286,299 | 4,951,549 | |
Total liabilities and stockholders' equity | $ 7,067,121 | $ 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 U.S. Securities and Exchange Commission (SEC) on February 26, 2024. |
BIOMARIN PHARMACEUTICAL INC. | |||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||
Six Months Ended June 30, 2024 and 2023 | |||
(In thousands of | |||
(unaudited) | |||
Six Months Ended June 30, | |||
2024 | 2023 | ||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net income | $ 195,836 | $ 106,892 | |
Adjustments to reconcile net income to net cash used in operating activities: | |||
Depreciation and amortization | 53,813 | 51,840 | |
Non-cash interest expense | 1,981 | 2,058 | |
Accretion of discount on investments | (4,678) | (4,533) | |
Stock-based compensation | 106,163 | 103,857 | |
Gain on sale of nonfinancial assets | (10,000) | — | |
Impairment of assets and other non-cash adjustments | 14,204 | 12,650 | |
Deferred income taxes | 1,537 | (5,108) | |
Unrealized foreign exchange loss (gain) | (19,958) | 7,455 | |
Other | (858) | 361 | |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (56,081) | (145,831) | |
Inventory | (47,409) | (56,476) | |
Other current assets | 1,615 | (53,430) | |
Other assets | (22,880) | (5,616) | |
Accounts payable and other short-term liabilities | (54,261) | (25,093) | |
Other long-term liabilities | 6,709 | 7,104 | |
Net cash provided by (used in) operating activities | 165,733 | (3,870) | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property, plant and equipment | (47,431) | (46,039) | |
Maturities and sales of investments | 317,649 | 491,063 | |
Purchases of investments | (195,462) | (444,049) | |
Proceeds from sale of nonfinancial assets | 10,000 | — | |
Purchase of intangible assets | (8,512) | (1,457) | |
Net cash provided by (used in) investing activities | 76,244 | (482) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercises of awards under equity incentive plans | 36,618 | 50,193 | |
Taxes paid related to net share settlement of equity awards | (66,739) | (67,862) | |
Payments of contingent consideration | — | (9,475) | |
Principal repayments of financing leases | (60) | (1,635) | |
Net cash used in financing activities | (30,181) | (28,779) | |
Effect of exchange rate changes on cash | 5,227 | 2,981 | |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 217,023 | (30,150) | |
Cash and cash equivalents: | |||
Beginning of period | $ 755,127 | $ 724,531 | |
End of period | $ 972,150 | $ 694,381 | |
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 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 diluted shares outstanding. 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 Operating Margin percentage, Non-GAAP Diluted EPS, Non-GAAP 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 Income and its components 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 Net Income to Non-GAAP Income(1) | |||||||
(In millions of | |||||||
(unaudited) | |||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
GAAP Reported Net Income | $ 107.2 | $ 56.0 | $ 195.8 | $ 106.9 | |||
Adjustments | |||||||
Stock-based compensation expense - COS | 3.8 | 4.7 | 7.0 | 9.1 | |||
Stock-based compensation expense - R&D | 12.9 | 15.1 | 33.6 | 34.9 | |||
Stock-based compensation expense - SG&A | 31.2 | 30.4 | 65.6 | 59.9 | |||
Amortization of intangible assets | 14.3 | 15.6 | 28.6 | 31.3 | |||
Gain on sale of nonfinancial assets (2) | — | — | (10.0) | — | |||
Severance and restructuring costs (3) | 39.1 | (2.2) | 42.5 | (0.1) | |||
Loss on investments (4) | 4.5 | — | 4.5 | 12.6 | |||
Income tax effect of adjustments | (24.1) | (14.4) | (39.0) | (33.6) | |||
Non-GAAP Income | $ 188.9 | $ 105.2 | $ 328.6 | $ 221.0 | |||
Reconciliation of Certain GAAP Reported Information to Non-GAAP Information(1) | |||||||
(in millions of | |||||||
(unaudited) | |||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2024 | 2024 | ||||||
Dollar | Percentage | Dollar | Percentage | ||||
GAAP Change in Total Revenues | $ 116.7 | 20 % | $ 169.2 | 14 % | |||
Adjustment for unfavorable impact of foreign currency exchange rates on product sales denominated in currencies other than | 29.9 | 52.6 | |||||
Non-GAAP change in Total Revenues at Constant Currency | $ 146.6 | 25 % | $ 221.8 | 19 % | |||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||
2024 | Percent | 2023 | Percent | 2024 | Percent | 2023 | Percent | ||
GAAP Income from Operations | $ 120.5 | 16.9 % | $ 65.6 | 11.0 % | $ 208.9 | 15.4 % | $ 128.0 | 10.7 % | |
Adjustments | |||||||||
Stock-based compensation expense | 47.9 | 6.8 % | 50.2 | 8.5 % | 106.2 | 7.7 % | 103.9 | 8.8 % | |
Amortization of intangible assets | 14.3 | 2.0 % | 15.6 | 2.6 % | 28.6 | 2.1 % | 31.3 | 2.6 % | |
Gain on sale of nonfinancial assets (2) | — | — % | — | — % | (10.0) | (0.7) % | — | — % | |
Severance and restructuring costs (3) | 39.1 | 5.5 % | (2.2) | (0.4) % | 42.5 | 3.1 % | (0.1) | — % | |
Total Non-GAAP adjustments | 101.3 | 14.3 % | 63.6 | 10.7 % | 167.3 | 12.2 % | 135.1 | 11.4 % | |
Non-GAAP Income from Operations | $ 221.8 | 31.2 % | $ 129.2 | 21.7 % | $ 376.2 | 27.6 % | $ 263.1 | 22.1 % | |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
GAAP Diluted EPS | $ 0.55 | $ 0.29 | $ 1.01 | $ 0.56 | |||
Adjustments | |||||||
Stock-based compensation expense | 0.24 | 0.25 | 0.53 | 0.52 | |||
Amortization of intangible assets | 0.07 | 0.08 | 0.14 | 0.16 | |||
Gain on sale of nonfinancial assets (2) | — | — | (0.05) | — | |||
Severance and restructuring costs (3) | 0.20 | (0.01) | 0.21 | — | |||
Loss on investments (4) | 0.02 | — | 0.02 | 0.06 | |||
Income tax effect of adjustments | (0.12) | (0.07) | (0.19) | (0.16) | |||
Non-GAAP Diluted EPS | $ 0.96 | $ 0.54 | $ 1.67 | $ 1.14 | |||
(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 quarter of 2024. These amounts also include impairments of certain right-of-use and fixed assets. |
(4) | Represents a downward adjustment to non-marketable equity securities recorded in Other expense, net. |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
GAAP Weighted-Average Dilutive Shares Outstanding | 200.5 | 195.0 | 200.1 | 194.8 | |||
Adjustments | |||||||
Common stock issuable under the company's convertible debt (1) | — | 4.4 | — | 4.4 | |||
Non-GAAP Weighted-Average Dilutive Shares Outstanding | 200.5 | 199.4 | 200.1 | 199.2 | |||
(1) | Common stock issuable under the company's convertible debt was excluded from the computation of GAAP Weighted-Average Dilutive Shares Outstanding when they were anti-dilutive. If converted, for the prior year comparative period, the company would have issued 4.4 million shares under the convertible notes due in 2027. |
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SOURCE BioMarin Pharmaceutical Inc.
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