On February 26, 2026 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the fourth quarter and full year 2025.
"These strong financial results for the fourth quarter and full year 2025 underscore our continued evolution as a global oncology leader with durable competitive advantages in clinical development and manufacturing and one of the industry’s deepest and most differentiated pipelines," said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. "BRUKINSA has firmly established itself as the global leader in the BTK inhibitor class, distinguished by broad regulatory approvals, expanding geographic reach, strong physician adoption, and unmatched long-term efficacy and safety data in CLL. At the same time, we are securing new indications and expanded reimbursement for TEVIMBRA across key markets worldwide. With our late-stage, foundational hematology assets nearing commercialization and a robust solid tumor portfolio delivering encouraging data, we are well positioned to extend our leadership and drive the next phase of sustainable global growth."
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(Amounts in thousands of U.S. dollars full year GAAP amounts audited, all other amounts unaudited)
Fourth Quarter Full Year
2025 2024 % Change 2025 2024 % Change
Net product revenues $ 1,476,442 $ 1,118,035 32 % $ 5,282,061 $ 3,779,546 40 %
Other revenue $ 21,728 $ 9,789 122 % $ 60,972 $ 30,695 99 %
Total revenue $ 1,498,170 $ 1,127,824 33 % $ 5,343,033 $ 3,810,241 40 %
GAAP income (loss) from operations $ 185,035 $ (79,425) 333 % $ 447,136 $ (568,199) 179 %
Adjusted income from operations* $ 344,476 $ 78,603 338 % $ 1,099,962 $ 45,356 2325 %
GAAP net income (loss) $ 66,502 $ (151,881) 144 % $ 286,933 $ (644,786) 145 %
Adjusted net income (loss)* $ 224,979 $ 16,101 1297 % $ 917,601 $ (54,919) 1771 %
GAAP basic earnings (loss) per ADS $ 0.60 $ (1.43) 142 % $ 2.63 $ (6.12) 143 %
Adjusted basic earnings (loss) per ADS* $ 2.03 $ 0.15 1253 % $ 8.41 $ (0.52) 1717 %
GAAP diluted earnings (loss) per ADS $ 0.58 $ (1.43) 141 % $ 2.53 $ (6.12) 141 %
Adjusted diluted earnings (loss) per ADS* $ 1.95 $ 0.15 1200 % $ 8.09 $ (0.52) 1656 %
Free Cash Flow* $ 379,825 $ (17,320) 2293 % $ 941,741 $ (633,294) 249 %
* 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.
Fourth Quarter and Full Year 2025 Financial Results
Product Revenue, which represents 99% of total revenue, totaled $1.5 billion and $5.3 billion for the fourth quarter and full year of 2025, representing growth of 32% and 40%, compared to the prior-year periods.
•BRUKINSA: Global sales totaled $1.1 billion and $3.9 billion the fourth quarter and full year of 2025, representing growth of 38% and 49%, compared to the prior-year periods; U.S. sales of BRUKINSA totaled $845 million and $2.8 billion in the fourth quarter and full year of 2025, representing growth of 37% and 45%, compared to the prior-year periods.
•TEVIMBRA (tislelizumab): Global sales totaled $182 million and $737 million, in the fourth quarter and full year of 2025, representing growth of 18% and 19%, compared to the prior-year periods.
•Amgen in-licensed products: Global sales totaled $112 million and $486 million for the fourth quarter and full year of 2025, representing growth of 11% and 33%, compared to prior-year periods.
Gross Margin as a percentage of global product sales for the fourth quarter and full year of 2025 was 90.4% and 87.3%, compared to 85.6% and 84.3%, in the prior-year periods on a GAAP basis. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of global product sales increased to 90.7% and 87.8% for the fourth quarter and full year of 2025, compared to 87.4% and 85.5%, in the prior-year periods.
Operating Expenses
The following table summarizes operating expenses for the fourth quarter of 2025 and 2024:
GAAP Non-GAAP
(in thousands, except percentages) Q4 2025 Q4 2024 % Change Q4 2025 Q4 2024 % Change
Research and development $ 615,423 $ 542,012 14 % $ 544,823 $ 474,874 15 %
Selling, general and administrative $ 555,290 $ 504,677 10 % $ 471,468 $ 433,059 9 %
Total operating expenses $ 1,170,713 $ 1,046,689 12 % $ 1,016,291 $ 907,933 12 %
The following table summarizes operating expenses for the full year 2025 and 2024:
GAAP Non-GAAP
(in thousands, except percentages) FY 2025 FY 2024 % Change FY 2025 FY 2024 % Change
Research and development $ 2,145,868 $ 1,953,295 10 % $ 1,855,979 $ 1,668,368 11 %
Selling, general and administrative $ 2,081,489 $ 1,831,056 14 % $ 1,743,118 $ 1,549,864 12 %
Total operating expenses $ 4,227,357 $ 3,784,351 12 % $ 3,599,097 $ 3,218,232 12 %
Research and Development (R&D) Expenses increased for the fourth quarter and full year of 2025 compared to the prior-year periods on both a GAAP and adjusted basis. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled nil and $0.7 million in the fourth quarter and full year of 2025, compared to $63 million and $114 million in the prior-year periods.
Selling, General and Administrative (SG&A) Expenses increased for the fourth quarter and full year of 2025 compared to the prior-year periods on both a GAAP and adjusted basis. SG&A expenses as a percentage of product sales were 38% and 39% for the fourth quarter and full year of 2025, compared to 45% and 48% in the prior-year periods.
Net Income/(Loss) and Basic/Diluted Earnings Per Share
GAAP net income for the fourth quarter and full year of 2025 was $67 million and $287 million, an increase of $218 million and $932 million, over the prior-year periods, primarily attributable to revenue growth and improved operating leverage. Included within GAAP net income for full year 2025 were $76 million of equity investment impairment charges, $25 million of non-recurring tax expenses and $20 million of timing related tax expenses in certain jurisdictions, which were primarily incurred in the fourth quarter.
For the fourth quarter of 2025, basic and diluted earnings per share were $0.05 and $0.04 per share and $0.60 and $0.58 per American Depositary Share (ADS), compared to basic loss of $0.11 per share and $1.43 per ADS in the prior-year period. For the full year of 2025, basic and diluted earnings per share were $0.20 and $0.19 per share and $2.63 and $2.53 per ADS, compared to basic loss of $0.47 per share and $6.12 per ADS in the prior-year period.
Free Cash Flow for the fourth quarter of 2025 was $380 million, representing an increase of $397 million over the prior-year period. For the full year of 2025, free cash flow was $942 million, representing an increase of $1.6 billion over the prior-year period.
For further details on BeOne’s 2025 Financial Statements, please see BeOne’s Annual Report on Form 10-K for fiscal year 2025 filed with the U.S. Securities and Exchange Commission.
Full Year 2026 Guidance
BeOne’s financial guidance is summarized below:
FY 20261
Total revenue $6.2 – $6.4 billion
GAAP gross margin % High-80% range
GAAP operating expenses2
(combined R&D and SG&A)
$4.7 – $4.9 billion
GAAP operating income2
$700 – $800 million
Non-GAAP operating income2,3
$1.4 – $1.5 billion
1Assumes January 1, 2026 foreign exchange rates.
2Does not assume any potential new, material business development activity or unusual/non-recurring items.
3Non-GAAP operating income is a financial measure that excludes from the corresponding GAAP measure costs related to share-based compensation, depreciation and amortization expense. Guidance assumes that Non-GAAP expenses track overall expense growth.
BeOne’s total revenue guidance for full year 2026 of $6.2 billion to $6.4 billion includes expectations for strong revenue growth driven by BRUKINSA’s U.S. leadership position and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and a full year of 2026 productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage.
The Company is providing the following additional guidance on items impacting net income and earnings per ADS:
•Other income (expense): estimated range of $25 million to $50 million in expense, includes interest amortization from Royalty Pharma arrangement.
•Income tax outlook: earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized; the timing and magnitude of a potential reversal is uncertain; prior to reversal, income tax expense should trend with earnings per historical relationship.
•Diluted ADS outstanding: the Company expects diluted ADSs outstanding of approximately 118 million.
Fourth Quarter Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•Presented 6-year landmark results from the Phase 3 SEQUOIA trial and long-term results from the Phase 3 ALPINE trial at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, confirming sustained benefit for the treatment of adult patients with treatment-naïve (TN) and relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), respectively.
Sonrotoclax (BCL2 inhibitor)
•Received first global approvals in China for the treatment of adult patients with:
◦R/R mantle cell lymphoma (MCL) who have received at least two systemic therapies, including a Bruton tyrosine kinase (BTK) inhibitor;
◦and R/R CLL/SLL who have previously received at least one systemic therapy, including a BTK inhibitor.
•Granted U.S. Food and Drug Administration (FDA) priority review for the treatment of adult patients with R/R MCL.
•Submitted Marketing Authorization Application in the European Union for the treatment of adult patients with R/R MCL.
•Enrolled first subject in Phase 3 trial in combination with BRUKINSA as a fixed-duration regimen versus acalabrutinib plus venetoclax for the treatment of adult patients with TN CLL.
TEVIMBRA (tislelizumab)
•Presented full results in partnership with Jazz Pharmaceuticals and Zymeworks from the HERIZON-GEA-01 trial in combination with ZIIHERA (zanidatamab) and chemotherapy, demonstrating statistically significant and clinically meaningful improvement in overall survival versus trastuzumab plus chemotherapy for the first-line treatment of adult patients with HER2-positive gastroesophageal adenocarcinoma (GEA).
Select Clinical-Stage Programs
Hematology
•BGB-16673 (BTK chimeric degradation activation compound (CDAC)): Presented results at ASH (Free ASH Whitepaper) from the Phase 1 CaDAnCe-101 trial for the treatment of adult patients with R/R CLL.
Breast and Gynecologic Cancers
•BG-75202 (KAT6A/B inhibitor): Initiated first in human study.
•BG-75908 (CDK2 CDAC): Initiated first in human study.
Lung Cancer
•BG-C0902 (EGFRxMETxMET antibody-drug conjugate): Initiated first in human study.
Gastrointestinal Cancers
•BGB-B2033 (GPC3x41BB bispecific antibody): Granted FDA Fast Track Designation for the treatment of adult patients with hepatocellular carcinoma who experience disease progression on or after post-systemic therapy
Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•Phase 3 MANGROVE trial interim analysis in combination with rituximab versus bendustamine plus rituximab for the treatment of adult patients with first-line MCL.
1H 2026
TEVIMBRA
•Supplemental Biologics License Application submissions in U.S. and China for the treatment of adult patients with first-line HER2-positive GEA in combination with zanidatamab.
1H 2026
•Japan regulatory approval for the treatment of adult patients with first-line gastric cancer.
2H 2026
Hematology
•Sonrotoclax (BCL2 inhibitor):
◦FDA regulatory action on New Drug Application as monotherapy treatment of adult patients with R/R MCL.
1H 2026
◦Phase 3 trial initiation for the treatment of adult patients with R/R multiple myeloma t(11;14).
2H 2026
•BGB-16673 (BTK CDAC):
◦Phase 2 potential accelerated approval submission (if data support) for the treatment of adult patients with R/R CLL.
2H 2026
Breast/Gynecologic Cancers
•BGB-43395 (CDK4 inhibitor):
◦Phase 3 trial initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer.
1H 2026
Gastrointestinal Cancers
•BGB-B2033 (GPC3x41BB bispecific antibody):
◦Potentially registrational Phase 2 trial initiation.
2H 2026
Inflammation and Immunology
•BGB-45035 (IRAK4 CDAC):
◦Phase 1/2 trial data readout for the treatment of adult patients with rheumatoid arthritis.
2H 2026
•BGB-16673 (BTK CDAC):
◦Phase 1b trial data readout for the treatment of adult patients with moderate to severe chronic spontaneous urticaria.
1H 2026
BeOne’s Earnings Results Webcast
The Company’s earnings conference call for the fourth quarter and full year 2025 will be broadcast via webcast at 8:00 a.m. ET on Thursday, February 26, 2026, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available.
(Press release, BeOne Medicines, FEB 26, 2026, View Source [SID1234663052])