BeiGene Announces Fourth Quarter and Full Year 2024 Financial Results and Business Updates
BeiGene (NASDAQ: ONC) reported strong financial results for Q4 and full year 2024, with total global revenues reaching $1.1 billion in Q4 (78% increase) and $3.8 billion for the full year (55% increase). Their flagship product BRUKINSA generated revenues of $828 million in Q4 and $2.6 billion annually, showing remarkable growth of 100% and 105% respectively.
The company provided 2025 revenue guidance of $4.9-5.3 billion and expects positive GAAP operating income and cash flow. BRUKINSA has become the market leader in new CLL patient starts in the U.S., with U.S. sales reaching $616 million in Q4 and $2.0 billion for the full year. European sales showed strong growth at $113 million in Q4 and $359 million annually.
The company advanced 13 New Molecular Entities into clinical trials during 2024 and anticipates multiple data readouts for innovative solid tumor programs in 1H 2025. BeiGene plans to change its name to BeOne Medicines , reflecting its evolution as a global oncology powerhouse.
BeiGene (NASDAQ: ONC) ha riportato risultati finanziari solidi per il quarto trimestre e per l'intero anno 2024, con ricavi globali totali che hanno raggiunto 1,1 miliardi di dollari nel quarto trimestre (incremento del 78%) e 3,8 miliardi di dollari per l'intero anno (incremento del 55%). Il loro prodotto di punta BRUKINSA ha generato ricavi di 828 milioni di dollari nel quarto trimestre e 2,6 miliardi di dollari annualmente, mostrando una crescita notevole del 100% e del 105% rispettivamente.
L'azienda ha fornito una previsione di ricavi per il 2025 di 4,9-5,3 miliardi di dollari e si aspetta un reddito operativo GAAP positivo e un flusso di cassa. BRUKINSA è diventato il leader di mercato per i nuovi pazienti CLL negli Stati Uniti, con vendite negli Stati Uniti che hanno raggiunto 616 milioni di dollari nel quarto trimestre e 2,0 miliardi di dollari per l'intero anno. Le vendite in Europa hanno mostrato una forte crescita a 113 milioni di dollari nel quarto trimestre e 359 milioni di dollari annualmente.
L'azienda ha avanzato 13 Nuove Entità Molecolari in studi clinici durante il 2024 e prevede molteplici letture di dati per programmi innovativi sui tumori solidi nel primo semestre del 2025. BeiGene prevede di cambiare il suo nome in BeOne Medicines, riflettendo la sua evoluzione come potenza globale nell'oncologia.
BeiGene (NASDAQ: ONC) reportó resultados financieros sólidos para el cuarto trimestre y el año completo 2024, con ingresos globales totales que alcanzaron 1.1 mil millones de dólares en el cuarto trimestre (aumento del 78%) y 3.8 mil millones de dólares para el año completo (aumento del 55%). Su producto insignia BRUKINSA generó ingresos de 828 millones de dólares en el cuarto trimestre y 2.6 mil millones de dólares anuales, mostrando un crecimiento notable del 100% y del 105% respectivamente.
La compañía proporcionó una guía de ingresos para 2025 de 4.9-5.3 mil millones de dólares y espera un ingreso operativo GAAP positivo y flujo de efectivo. BRUKINSA se ha convertido en el líder del mercado en nuevos pacientes con CLL en EE. UU., con ventas en EE. UU. alcanzando 616 millones de dólares en el cuarto trimestre y 2.0 mil millones de dólares para el año completo. Las ventas en Europa mostraron un fuerte crecimiento de 113 millones de dólares en el cuarto trimestre y 359 millones de dólares anuales.
La compañía avanzó 13 Nuevas Entidades Moleculares a ensayos clínicos durante 2024 y anticipa múltiples lecturas de datos para programas innovadores de tumores sólidos en la primera mitad de 2025. BeiGene planea cambiar su nombre a BeOne Medicines, reflejando su evolución como una potencia global en oncología.
BeiGene (NASDAQ: ONC)는 2024년 4분기 및 전체 연도에 대한 강력한 재무 결과를 보고했으며, 글로벌 총 수익이 4분기 11억 달러에 도달했으며(78% 증가) 전체 연도는 38억 달러에 달했습니다(55% 증가). 그들의 주력 제품 BRUKINSA는 4분기에 8억 2800만 달러의 수익을 올렸고, 연간 26억 달러를 기록하여 각각 100% 및 105%의 놀라운 성장을 보였습니다.
회사는 2025년 수익 가이드를 49억-53억 달러로 제공했으며, 긍정적인 GAAP 운영 수익 및 현금 흐름을 기대하고 있습니다. BRUKINSA는 미국에서 새로운 CLL 환자 시작의 시장 리더가 되었으며, 미국 판매는 4분기에 6억 1600만 달러, 전체 연도에는 20억 달러에 도달했습니다. 유럽 판매도 4분기에 1억 1300만 달러, 연간 3억 5900만 달러로 강력한 성장을 보였습니다.
회사는 2024년에 13개의 새로운 분자 개체를 임상 시험으로 진전시켰으며, 2025년 상반기에 혁신적인 고형 종양 프로그램에 대한 여러 데이터 공개를 예상하고 있습니다. BeiGene은 글로벌 종양학 강국으로서의 진화를 반영하여 BeOne Medicines로 이름을 변경할 계획입니다.
BeiGene (NASDAQ: ONC) a rapporté de solides résultats financiers pour le quatrième trimestre et l'année entière 2024, avec des revenus globaux totaux atteignant 1,1 milliard de dollars au quatrième trimestre (augmentation de 78%) et 3,8 milliards de dollars pour l'année entière (augmentation de 55%). Leur produit phare BRUKINSA a généré des revenus de 828 millions de dollars au quatrième trimestre et 2,6 milliards de dollars annuellement, montrant une croissance remarquable de 100% et 105% respectivement.
L'entreprise a fourni une prévision de revenus pour 2025 de 4,9-5,3 milliards de dollars et s'attend à un revenu opérationnel GAAP positif ainsi qu'à un flux de trésorerie positif. BRUKINSA est devenu le leader du marché pour les nouveaux patients CLL aux États-Unis, avec des ventes aux États-Unis atteignant 616 millions de dollars au quatrième trimestre et 2,0 milliards de dollars pour l'année entière. Les ventes en Europe ont montré une forte croissance à 113 millions de dollars au quatrième trimestre et 359 millions de dollars annuellement.
L'entreprise a avancé 13 Nouvelles Entités Moléculaires dans des essais cliniques en 2024 et anticipe plusieurs publications de données pour des programmes innovants sur les tumeurs solides au premier semestre 2025. BeiGene prévoit de changer son nom en BeOne Medicines, reflétant son évolution en tant que puissance mondiale en oncologie.
BeiGene (NASDAQ: ONC) berichtete über starke finanzielle Ergebnisse für das vierte Quartal und das gesamte Jahr 2024, wobei die globalen Gesamteinnahmen im vierten Quartal 1,1 Milliarden US-Dollar erreichten (78% Steigerung) und 3,8 Milliarden US-Dollar für das gesamte Jahr (55% Steigerung). Ihr Flaggschiffprodukt BRUKINSA erzielte Einnahmen von 828 Millionen US-Dollar im vierten Quartal und 2,6 Milliarden US-Dollar jährlich, mit bemerkenswertem Wachstum von 100% bzw. 105%.
Das Unternehmen gab eine Umsatzprognose für 2025 von 4,9-5,3 Milliarden US-Dollar bekannt und erwartet ein positives GAAP-Betriebsergebnis sowie einen positiven Cashflow. BRUKINSA ist zum Marktführer bei neuen CLL-Patienten in den USA geworden, mit einem Umsatz von 616 Millionen US-Dollar im vierten Quartal und 2,0 Milliarden US-Dollar für das gesamte Jahr. Die europäischen Verkäufe zeigten ein starkes Wachstum von 113 Millionen US-Dollar im vierten Quartal und 359 Millionen US-Dollar jährlich.
Das Unternehmen hat 2024 insgesamt 13 neue molekulare Entitäten in klinische Studien vorangebracht und erwartet mehrere Datenveröffentlichungen für innovative Programme zu soliden Tumoren im ersten Halbjahr 2025. BeiGene plant, seinen Namen in BeOne Medicines zu ändern, um seine Entwicklung zu einem globalen Onkologie-Powerhouse widerzuspiegeln.
- Record BRUKINSA sales growth: 100% Q4 increase to $828M, 105% annual increase to $2.6B
- Strong total revenue growth: 78% Q4 increase to $1.1B, 55% annual increase to $3.8B
- Market leadership in CLL new patient starts in U.S.
- Improved gross margin to 85.6% in Q4 2024
- Positive 2025 guidance: $4.9-5.3B revenue expected
- Operating losses still present (though narrowing)
- R&D expenses increased due to clinical program advancement
- Patent settlement allows generic BRUKINSA entry by June 2037
Insights
BeiGene's Q4 and FY2024 results showcase exceptional growth with total revenues surging 78% to $1.1 billion for Q4 and 55% to $3.8 billion for the full year. This performance significantly outpaces the broader oncology sector's typical growth rate of 15-20%, positioning BeiGene among the fastest-growing mid-cap oncology companies.
BRUKINSA continues to be the primary growth catalyst, with revenues doubling year-over-year to $828 million in Q4 and $2.6 billion for the full year. The drug has captured market leadership in new CLL patient starts in the U.S., demonstrating successful commercial execution against entrenched competitors. The patent settlement with MSN Pharmaceuticals secures market exclusivity until at least 2037, effectively removing a significant long-term risk factor and providing over a decade of protected revenue potential.
Gross margin expansion to 85.6% in Q4 (from 83.2% in Q4 2023) reflects both favorable product mix and operational efficiency gains, despite absorbing
The company's 2025 guidance of
The pipeline progression, with 13 new molecular entities entering the clinic in 2024 and multiple potential catalysts in 2025, provides significant optionality beyond the core BRUKINSA franchise. The company's strategic pivot toward building solid tumor franchises in breast, lung, and gastrointestinal cancers represents a substantial market expansion opportunity that could drive the next wave of growth as the hematology portfolio matures.
BeiGene's clinical portfolio demonstrates remarkable breadth and strategic focus on mechanistically differentiated approaches across both hematologic and solid tumors. BRUKINSA's commercial success stems from its pharmacokinetic advantages that enable complete and sustained BTK inhibition with minimal off-target effects, resulting in superior tolerability while maintaining efficacy. This has translated to real-world leadership in new CLL patient starts and provides a strong foundation for combination approaches.
Their hematology pipeline shows particular promise with sonrotoclax, a BCL2 inhibitor designed to overcome the limitations of venetoclax. The ASH data revealed not only absence of progression in treatment-naïve CLL patients when combined with BRUKINSA, but also encouraging complete response rates without the tumor lysis syndrome concerns that complicate venetoclax administration. This potentially eliminates the need for complex dose ramp-up protocols that burden both patients and healthcare systems.
The BTK CDAC (BGB-16673) represents a fundamentally different approach to BTK inhibition through protein degradation rather than just enzymatic inhibition. This mechanism can potentially overcome the C481S and other mutations that drive resistance to covalent BTK inhibitors while also addressing the gatekeeper mutations that limit noncovalent inhibitors like pirtobrutinib. The planned head-to-head trial against pirtobrutinib will be particularly informative.
In solid tumors, BeiGene is strategically focusing on three key areas with significant unmet needs. Their lung cancer approach with the EGFR CDAC (BG-60366) targets a fundamental limitation of current EGFR inhibitors by completely abolishing EGFR signaling rather than just inhibiting kinase activity, potentially addressing both on-target and bypass resistance mechanisms. The combination of PRMT5 inhibition (BGB-58067) with MAT2A inhibition (BG-89894) exploits synthetic lethality in MTAP-deleted tumors, which represent approximately 15% of all human cancers.
Their breast cancer strategy with selective CDK4 inhibition (BGB-43395) aims to maintain efficacy while reducing the neutropenia associated with dual CDK4/6 inhibition, potentially enabling more effective combinations with endocrine therapy. The B7H4 ADC program targets a highly tumor-selective antigen with minimal normal tissue expression, potentially offering a wider therapeutic window than current ADC approaches.
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Total global revenues of
$1.1 billion $3.8 billion 78% and55% , respectively; narrowed GAAP operating loss and achieved full-year positive non-GAAP operating income -
Global BRUKINSA revenues of
$828 million $2.6 billion 100% and105% , respectively; progressed pivotal-stage programs for BCL2 inhibitor sonrotoclax and BTK CDAC BGB-16673 - Advanced six and 13 New Molecular Entities (NMEs) into the clinic in the fourth quarter and full year, respectively; anticipate multiple data readouts for innovative solid tumor programs in 1H 2025
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Full year 2025 revenue guidance of
$4.9 billion $5.3 billion
(Graphic: Business Wire)
“Our fourth quarter and full year results demonstrate our tremendous growth as a global oncology powerhouse, reinforced by the continued success of BRUKINSA and the development of one of the most prolific solid tumor pipelines in oncology with multiple data readouts expected this year,” said John V. Oyler, Co-Founder, Chairman, and CEO at BeiGene. “BRUKINSA is now the unequivocal leader in new CLL patient starts in the
Fourth Quarter and Full Year 2024 Financial Snapshot
(Amounts in thousands of
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Fourth Quarter |
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Full Year |
|
|
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|
|
2024 |
|
2023 |
|
% Change |
|
2024 |
|
2023 |
|
% Change |
||||||||||
Net product revenues |
|
$ |
1,118,035 |
|
|
$ |
630,526 |
|
|
77 |
% |
|
$ |
3,779,546 |
|
|
$ |
2,189,852 |
|
|
73 |
% |
Net revenue from collaborations |
|
$ |
9,789 |
|
|
$ |
3,883 |
|
|
152 |
% |
|
$ |
30,695 |
|
|
$ |
268,927 |
|
|
(89 |
)% |
Total revenue |
|
$ |
1,127,824 |
|
|
$ |
634,409 |
|
|
78 |
% |
|
$ |
3,810,241 |
|
|
$ |
2,458,779 |
|
|
55 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
GAAP loss from operations |
|
$ |
(79,425 |
) |
|
$ |
(383,795 |
) |
|
(79 |
)% |
|
$ |
(568,199 |
) |
|
$ |
(1,207,736 |
) |
|
(53 |
)% |
Adjusted income (loss) from operations* |
|
$ |
78,603 |
|
|
$ |
(267,224 |
) |
|
129 |
% |
|
$ |
45,356 |
|
|
$ |
(752,473 |
) |
|
106 |
% |
* For an explanation of our use of non-GAAP financial measures refer to the "Note Regarding Use of Non-GAAP Financial Measures" section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release.
Key Business Updates
BRUKINSA® (zanubrutinib) is an orally available, small molecule inhibitor of BTK designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. The BRUKINSA clinical development program includes approximately 7,100 patients enrolled to date in more than 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 70 markets, and more than 180,000 patients have been treated globally.
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U.S. sales of BRUKINSA totaled$616 million $2.0 billion 97% and106% , respectively, over the prior-year periods, with more than60% of the quarter-over-quarter demand growth coming from expanded use in chronic lymphocytic leukemia (CLL) as BRUKINSA continued to gain share as the leader in new patient starts in theU.S. in CLL and all other approved indications; BRUKINSA sales inEurope totaled$113 million $359 million 148% and194% , respectively, compared to the prior-year periods, driven by increased market share across all major markets, includingGermany ,Italy ,Spain ,France and theUK ; and -
Entered into a patent litigation settlement agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories Private Ltd. granting MSN the right to sell a generic version of BRUKINSA in the
U.S. no earlier than June 15, 2037, subject to potential acceleration or extension under circumstances customary for settlement of this type.
TEVIMBRA® (tislelizumab) is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1; it is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. TEVIMBRA is the foundational asset of BeiGene’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 counties and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 45 markets, and more than 1.3 million patients have been treated globally.
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Sales of tislelizumab totaled
$154 million $621 million 20% and16% , respectively, compared to the prior-year periods; -
Received
U.S. Food and Drug Administration (FDA) approval in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (≥1); and - Received European Commission (EC) approval in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma.
Key Pipeline Highlights
BeiGene’s portfolio strategy emphasizes rapid generation of early-stage clinical proof-of-concept data enabled by its speed- and cost-advantaged (“Fast to Proof of Concept”) approach to global development operations. The Company’s in-house global research and development team, including clinical operations and development, is comprised of nearly 3,700 colleagues conducting trials across six continents and striving to ensure rigorous data quality through collaborations with regulators and investigators in over 45 countries. This strategic approach maximizes resources by channeling data-gated investments into the most promising clinically differentiated candidates quickly and de-prioritizing others. With one of the largest oncology research teams in the industry, BeiGene has demonstrated strengths in translational small molecule and biologics discovery, including three platform technologies: multi-specific antibodies, chimeric degradation activation compounds (CDACs), and antibody-drug conjugates (ADCs).
Hematology
BRUKINSA
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At the American Society of Hematology (ASH) Annual meeting, presented 5-year follow-up from SEQUOIA study; with adjustment for COVID-19 impact, the study demonstrated treatment with BRUKINSA reduced the risk of progression or death by
75% compared to bendamustine-rituximab in patients with treatment-naïve (TN) CLL; - Anticipate FDA and EC approvals of BRUKINSA tablet formulation in the second half of 2025;
- Anticipate an interim analysis of progression-free survival for the Phase 3 MANGROVE study in TN mantle cell lymphoma (MCL) in the second half of 2025; and
- Anticipate completing enrollment for the relapsed/refractory (R/R) follicular lymphoma portion of the Phase 3 MAHOGANY study in the second half of 2025.
Sonrotoclax (BCL2 inhibitor)
- Planned data readouts in R/R CLL and R/R MCL Phase 2 trials and potential accelerated approval submissions in the second half of 2025;
- At ASH, presented data from the 320 mg expansion cohort of a Phase 1/1b study at a median follow-up of 1.5 years demonstrating no progression in patients with TN CLL in combination with BRUKINSA;
- More than 1,800 patients enrolled to date across the program;
- Completed enrollment in Phase 3 CELESTIAL study in TN CLL;
- Anticipate enrolling first subjects in global Phase 3 trials in R/R CLL and R/R MCL in the first half of 2025; and
- Continued enrollment in global Phase 2 trial in Waldenström’s macroglobulinemia.
BGB-16673 (BTK CDAC)
- Continued to enroll potentially registration enabling R/R CLL Phase 2 study with data readout expected in 2026;
- More than 500 patients enrolled to date across the program;
- Anticipate initiation of Phase 3 trial in R/R CLL compared to physician’s choice in the first half of 2025; and
- Anticipate initiation of Phase 3 head-to-head trial against noncovalent BTK inhibitor pirtobrutinib in R/R CLL in the second half of 2025.
Solid Tumors
Anticipate data readouts for BGB-43395 (CDK4 inhibitor), BG-68501 (CDK2 inhibitor) and BG-C9074 (B7H4 ADC) in the first half of 2025, and internal proof-of-concept data for BG-60366 (EGFR CDAC), BGB-53038 (panKRAS inhibitor), BG-C137 (FGFR2b ADC), BGB-C354 (B7H3 ADC), and BG-C477 (CEA ADC) in the second half of 2025.
Lung Cancer
- Tarlatamab (AMG757, DLL3xCD3 BiTE): anticipate data readout from Phase 3 study in second-line small cell lung cancer in the first half of 2025;
- Advan-TIG-302 (TIGIT antibody): anticipate interim data readout from Phase 3 study in first-line PD(L)1-high non small cell lung cancer in the second half of 2025;
- BG-60366 (EGFR CDAC): entered into the clinic in the fourth quarter of 2024; differentiated degrader mechanism to completely abolish EGFR signaling; highly potent across osimertinib-sensitive and resistant EGFR mutations; strong preclinical efficacy data with oral and daily dosing;
- BG-89894 (MAT2A inhibitor): entered dose escalation in fourth quarter of 2024; potential best-in-class characteristics with superior potency and brain penetration; strong synergy between PRMT5i and MAT2Ai in preclinical models;
- BGB-58067 (MTA-cooperative PRMT5 inhibitor): entered into the clinic in the beginning of January 2025; best-in-class potential with high potency, selectivity, and brain penetrability; and
- BG-T187 (EGFR x MET trispecific antibody): initiated dose escalation in fourth quarter of 2024; differentiated MET biparatopic design with optimal MET inhibitory activity to pursue best-in-class opportunity.
Breast and Gynecologic Cancers
- BGB-43395 (CDK4 inhibitor): continued dose escalation in monotherapy and in combination with fulvestrant and letrozole in the anticipated efficacious dose range; more than 180 patients enrolled to date and proof-of-concept expected in the first half of 2025; planning underway for Phase 3 trial in second-line HR+/HER2- metastatic breast cancer in combination with endocrine therapy; and
- BG-68501(CDK2 inhibitor) and BG-C9074 (B7H4 ADC): continued monotherapy dose escalation; more than 50 patients and more than 70 patients enrolled to date, respectively.
Gastrointestinal Cancers
- Zanidatamab (HER2 bispecific antibody) in combination with tislelizumab and chemotherapy: anticipate primary PFS data readout from Phase 3 study in first-line HER2-positive gastroesophageal adenocarcinoma in the second half of 2025; and
-
NMEs advanced into the clinic in the fourth quarter of 2024:
- BGB-53038 (panKRAS inhibitor): highly potent and selective with broad activity against KRAS mutations in multiple tumor types; limits toxicity by sparing other RAS proteins; KRAS mutations are present in 19 percent of cancers; and
- BG-C137 (FGFR2b ADC): potential first-in-class ADC for a validated target in upper gastrointestinal and breast cancers; potential superior efficacy compared to leading monoclonal antibody in both high- and medium-expression models.
Inflammation and Immunology
BGB-45035 (IRAK4 CDAC): currently in dose escalation in both SAD and MAD cohorts with more than 130 subjects enrolled; potent and selective degrader that targets both kinase and scaffold functions of IRAK4 for complete target degradation; Phase 2 study planned in 2025; proof-of-concept for tissue IRAK4 degradation in the second half of 2025.
Corporate Updates
- Announced intent to change the Company’s name to BeOne Medicines, pending shareholder approval; the new name reflects the Company’s commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible;
-
Announced a global licensing agreement with CSPC Zhongqi Pharmaceutical Technology (
Shijiazhuang ) Co., Ltd. for SYH2039 (BG-89894), a novel MAT2A inhibitor being explored for solid tumors as monotherapy and in combination with BGB-58067 (MTA-cooperative PRMT5 inhibitor); - Changed the Company’s Nasdaq stock ticker from “BGNE” to “ONC”; and
- Hosted an investor webinar on December 16, 2024, highlighting key data from the hematology franchise from the ASH 2024 and the 2024 San Antonio Breast Cancer Symposium and presented at the 2025 J.P. Morgan Healthcare Conference on January 13, 2025. Replays and materials can be found at the Investor Events and Presentations section of the Company’s website.
Fourth Quarter and Full Year 2024 Financial Highlights
Revenue for the fourth quarter and full year 2024 was
Product Revenue totaled
Gross Margin as a percentage of global product sales for the fourth quarter and full year 2024 was
Operating Expenses
The following table summarizes operating expenses for the fourth quarter 2024 and 2023, respectively:
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(in thousands, except percentages) |
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Q4 2024 |
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Q4 2023 |
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Q4 2024 |
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Q4 2023 |
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Research and development |
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Selling, general and administrative |
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Total operating expenses |
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The following table summarizes operating expenses for the full year 2024 and 2023, respectively:
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(in thousands, except percentages) |
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FY 2023 |
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FY 2024 |
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FY 2023 |
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Research and development |
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Selling, general and administrative |
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Total operating expenses |
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Research and Development (R&D) Expenses increased for the fourth quarter and full year 2024 compared to the prior-year periods on both a GAAP and adjusted basis primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled
Selling, General and Administrative (SG&A) Expenses increased for the fourth quarter and full year 2024 compared to the prior-year periods on both a GAAP and adjusted basis due to continued investment in the global commercial launch of BRUKINSA primarily in the
Net Loss
GAAP net loss improved for the fourth quarter and full year 2024, as compared to the prior-year periods, primarily attributable to reduced operating losses.
For the fourth quarter of 2024, net loss per share was
Cash Provided by Operations for the fourth quarter 2024 was
For further details on BeiGene’s 2024 Financial Statements, please see BeiGene’s Annual Report on Form 10-K for fiscal year 2024 filed with the
Full Year 2025 Guidance
BeiGene’s financial guidance is summarized below:
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GAAP Operating Expenses (R&D and SG&A) |
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|
|
|||
Additional: |
GAAP Gross Margin Percentage in mid |
|
||
Positive Full Year GAAP Operating Income |
|
|||
|
Generation of Positive Cash Flow from Operations |
|
||
1 Does not assume any potential new, material business development activity or unusual/non-recurring items. Assumes January 31, 2025 foreign exchange rates.
BeiGene’s total revenue guidance for full year 2025 of
Conference Call and Webcast
The Company’s earnings conference call for the fourth quarter and full year 2024 will be broadcast via webcast at 8:00 a.m. ET on Thursday, February 27, 2025, and will be accessible through the Investors section of BeiGene’s website, www.beigene.com. Supplemental information in the form of a slide presentation and a replay of the webcast will also be available.
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.
BeiGene intends to use the Investors section of its website, its X (formerly known as Twitter) account at x.com/BeiGeneGlobal, its LinkedIn account at linkedin.com/company/BeiGene, its Facebook account at facebook.com/BeiGeneGlobal, and its Instagram account at instagram.com/BeiGeneGlobal to disclose material information and to comply with its disclosure obligations under Regulation FD. Accordingly, investors should monitor BeiGene’s website, its X account, its LinkedIn account, its Facebook account, and its Instagram account in addition to BeiGene’s press releases, SEC filings, public conference calls, presentations, and webcasts.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding timing of proof-of-concept data readouts, clinical trial activities and readouts, study enrollment, and regulatory approvals; BeiGene’s future revenue, operating income, cash flow, operating expenses and gross margin percentage; the future of BeiGene’s solid tumor pipeline and its ability to address unmet patient need across multiple disease areas and therapeutic modalities; the future success of BeiGene’s clinical trials and new molecular entities; and BeiGene’s plans, commitments, aspirations and goals under the caption “About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the
Condensed Consolidated Statements of Operations ( |
||||||||
(Amounts in thousands of |
||||||||
|
Fourth Quarter |
|
Full Year |
|||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
(unaudited) |
|
(audited) |
|||||
Revenue |
|
|
|
|
|
|
|
|
Product revenue, net |
|
|
|
|
|
|
|
|
Collaboration revenue |
9,789 |
|
3,883 |
|
30,695 |
|
268,927 |
|
Total revenues |
1,127,824 |
|
634,409 |
|
3,810,241 |
|
2,458,779 |
|
Cost of sales - products |
160,560 |
|
105,832 |
|
594,089 |
|
379,920 |
|
Gross profit |
967,264 |
|
528,577 |
|
3,216,152 |
|
2,078,859 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
542,012 |
|
493,987 |
|
1,953,295 |
|
1,778,594 |
|
Selling, general and administrative |
504,677 |
|
418,385 |
|
1,831,056 |
|
1,508,001 |
|
Total operating expenses |
1,046,689 |
|
912,372 |
|
3,784,351 |
|
3,286,595 |
|
Loss from operations |
(79,425) |
|
(383,795) |
|
(568,199) |
|
(1,207,736) |
|
Interest income , net |
7,808 |
|
16,274 |
|
47,836 |
|
74,009 |
|
Other (expense) income, net |
(13,734) |
|
16,749 |
|
(12,638) |
|
307,891 |
|
Loss before income taxes |
(85,351) |
|
(350,772) |
|
(533,001) |
|
(825,836) |
|
Income tax expense |
66,530 |
|
16,781 |
|
111,785 |
|
55,872 |
|
Net loss |
(151,881) |
|
(367,553) |
|
(644,786) |
|
(881,708) |
|
|
|
|
|
|
|
|
|
|
Net loss per share |
|
|
|
|
|
|
|
|
Weighted-average shares outstanding—basic and diluted |
1,381,378,234 |
|
1,353,005,058 |
|
1,368,746,793 |
|
1,357,034,547 |
|
|
|
|
|
|
|
|
|
|
Net loss per American Depositary Share (“ADS”) |
|
|
|
|
|
|
|
|
Weighted-average ADSs outstanding—basic and diluted |
106,259,864 |
|
104,077,312 |
|
105,288,215 |
|
104,387,273 |
|
Select Condensed Consolidated Balance Sheet Data ( |
||||
(Amounts in thousands of |
||||
|
|
|
|
|
|
As of |
|||
|
December 31, |
|
December 31, |
|
|
2024 |
|
2023 |
|
|
(audited) |
|||
Assets: |
|
|
|
|
Cash, cash equivalents and restricted cash |
|
|
|
|
Accounts receivable, net |
676,278 |
|
358,027 |
|
Inventories, net |
494,986 |
|
416,122 |
|
Property, plant and equipment, net |
1,578,423 |
|
1,324,154 |
|
Total assets |
|
|
|
|
Liabilities and equity: |
|
|
|
|
Accounts payable |
|
|
|
|
Accrued expenses and other payables |
803,713 |
|
693,731 |
|
R&D cost share liability |
165,440 |
|
238,666 |
|
Debt |
1,018,013 |
|
885,984 |
|
Total liabilities |
2,588,688 |
|
2,267,948 |
|
Total equity |
|
|
|
|
Select Unaudited Condensed Consolidated Statements of Cash Flows ( |
||||||||||||||||
(Amounts in thousands of |
||||||||||||||||
|
|
Fourth Quarter |
|
Full Year |
||||||||||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||||||
|
|
(unaudited) |
|
(audited) |
||||||||||||
Cash, cash equivalents and restricted cash at beginning of period |
|
$ |
2,713,428 |
|
|
$ |
3,080,892 |
|
|
$ |
3,185,984 |
|
|
$ |
3,875,037 |
|
Net cash provided by (used in) operating activities |
|
|
75,160 |
|
|
|
(221,638 |
) |
|
|
(140,631 |
) |
|
|
(1,157,453 |
) |
Net cash (used in) provided by investing activities |
|
|
(93,605 |
) |
|
|
(62,584 |
) |
|
|
(548,350 |
) |
|
|
60,004 |
|
Net cash (used in) provided by financing activities |
|
|
(4,523 |
) |
|
|
347,048 |
|
|
|
193,449 |
|
|
|
416,478 |
|
Net effect of foreign exchange rate changes |
|
|
(51,713 |
) |
|
|
42,266 |
|
|
|
(51,705 |
) |
|
|
(8,082 |
) |
Net (decrease) increase in cash, cash equivalents and restricted cash |
|
|
(74,681 |
) |
|
|
105,092 |
|
|
|
(547,237 |
) |
|
|
(689,053 |
) |
Cash, cash equivalents and restricted cash at end of period |
|
$ |
2,638,747 |
|
|
$ |
3,185,984 |
|
|
$ |
2,638,747 |
|
|
$ |
3,185,984 |
|
Note Regarding Use of Non-GAAP Financial Measures
BeiGene provides certain non-GAAP financial measures, including Adjusted Operating Expenses and Adjusted Operating Loss and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeiGene’s operating performance. Adjustments to BeiGene’s GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. BeiGene maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeiGene believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeiGene’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Company’s historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators BeiGene’s management uses for planning and forecasting purposes and measuring the Company’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies.
RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES |
||||||||
(Amounts in thousands of |
||||||||
(unaudited) |
||||||||
|
|
Fourth Quarter |
|
Full Year |
||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Reconciliation of GAAP to adjusted cost of sales - products: |
|
|
|
|
|
|
|
|
GAAP cost of sales - products |
|
|
|
|
|
|
|
|
Less: Depreciation |
|
18,089 |
|
1,898 |
|
42,707 |
|
8,578 |
Less: Amortization of intangibles |
|
1,183 |
|
1,119 |
|
4,729 |
|
3,739 |
Adjusted cost of sales - products |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to adjusted research and development: |
|
|
|
|
|
|
|
|
GAAP research and development |
|
|
|
|
|
|
|
|
Less: Share-based compensation expenses |
|
44,992 |
|
39,424 |
|
186,113 |
|
163,550 |
Less: Depreciation |
|
22,146 |
|
17,180 |
|
98,814 |
|
56,084 |
Adjusted research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to adjusted selling, general and administrative: |
|
|
|
|
|
|
|
|
GAAP selling, general and administrative |
|
|
|
|
|
|
|
|
Less: Share-based compensation expenses |
|
62,790 |
|
53,328 |
|
255,680 |
|
204,038 |
Less: Depreciation |
|
8,811 |
|
1,784 |
|
25,417 |
|
15,774 |
Less: Amortization of intangibles |
|
17 |
|
1,838 |
|
95 |
|
3,500 |
Adjusted selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to adjusted operating expenses |
|
|
|
|
|
|
|
|
GAAP operating expenses |
|
1,046,689 |
|
912,372 |
|
3,784,351 |
|
3,286,595 |
Less: Share-based compensation expenses |
|
107,782 |
|
92,752 |
|
441,793 |
|
367,588 |
Less: Depreciation |
|
30,957 |
|
18,964 |
|
124,231 |
|
71,858 |
Less: Amortization of intangibles |
|
17 |
|
1,838 |
|
95 |
|
3,500 |
Adjusted operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to adjusted loss from operations: |
|
|
|
|
|
|
|
|
GAAP loss from operations |
|
|
|
|
|
|
|
|
Plus: Share-based compensation expenses |
|
107,782 |
|
92,752 |
|
441,793 |
|
367,588 |
Plus: Depreciation |
|
49,046 |
|
20,862 |
|
166,938 |
|
80,436 |
Plus: Amortization of intangibles |
|
1,200 |
|
2,957 |
|
4,824 |
|
7,239 |
Adjusted income (loss) from operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20250227911272/en/
Investor Contact
Liza Heapes
+1 857-302-5663
ir@beigene.com
Media Contact
Kyle Blankenship
+1 667-351-5176
media@beigene.com
Source: BeiGene, Ltd.
FAQ
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What is BeiGene's (ONC) total global revenue for full year 2024?
