On November 6, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the third quarter of 2025.
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"These strong financial results reinforce our position as a global oncology leader with exceptional topline growth and a strong balance sheet," said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. "BRUKINSA is now the global revenue leader in the BTKi class, supported by long-term efficacy and safety data and a growing body of evidence reinforcing its scientific hypothesis of sustained BTK inhibition. Our late-stage hematology portfolio continues to advance with sonrotoclax, a potentially best-in-class BCL2 inhibitor that has demonstrated impressive clinical results, and our BTK CDAC BGB-16673, further strengthening our leadership in B cell malignancies, including CLL. With one of the most promising oncology pipelines in the industry, we are poised to deliver multiple data and regulatory milestones that will drive long-term value."
(Amounts in thousands of U.S. dollars and unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 % Change 2025 2024 % Change
Net product revenues $ 1,395,013 $ 993,447 40 % $ 3,805,619 $ 2,661,511 43 %
Other revenue $ 17,271 $ 8,152 112 % $ 39,244 $ 20,906 88 %
Total revenue $ 1,412,284 $ 1,001,599 41 % $ 3,844,863 $ 2,682,417 43 %
GAAP income (loss) from operations $ 163,114 $ (120,265) 236 % $ 262,101 $ (488,774) 154 %
Adjusted income (loss) from operations* $ 341,184 $ 65,630 420 % $ 755,486 $ (33,247) 2372 %
GAAP net income (loss) $ 124,841 $ (121,350) 203 % $ 220,431 $ (492,905) 145 %
Adjusted net income (loss)* $ 303,663 $ 51,582 489 % $ 692,622 $ (71,020) 1075 %
GAAP basic EPS per ADS $ 1.13 $ (1.15) 198 % $ 2.03 $ (4.71) 143 %
Adjusted basic EPS per ADS* $ 2.76 $ 0.49 463 % $ 6.38 $ (0.68) 1038 %
GAAP diluted EPS per ADS $ 1.09 $ (1.15) 195 % $ 1.96 $ (4.71) 142 %
Adjusted diluted EPS per ADS* $ 2.65 $ 0.48 452 % $ 6.14 $ (0.68) 1003 %
Free Cash Flow* $ 354,469 $ 54,714 548 % $ 561,916 $ (615,974) 191 %
Third Quarter 2025 Financial Results
Revenue for the third quarter of 2025 was $1.4 billion, compared to $1.0 billion in the prior-year period driven primarily by growth in BRUKINSA product sales in the U.S. and Europe.
Product Revenue totaled $1.4 billion for the third quarter of 2025 compared to $993 million in the prior-year period. The increase in product revenue was primarily attributable to increased sales of BRUKINSA. The U.S. continued to be the Company’s largest market, with product revenue of $743 million compared to $504 million in the prior-year period. In-licensed products from Amgen and TEVIMBRA (tislelizumab) also contributed to product revenue growth.
•U.S. sales of BRUKINSA totaled $739 million in the third quarter of 2025, representing growth of 47% over the prior-year period driven primarily by robust demand growth across all indications and modest benefit due to net pricing. BRUKINSA continues to maintain its leading new patient share across the BTKi class due to its differentiated, best-in-class clinical profile. BRUKINSA sales in Europe totaled $163 million in the third quarter of 2025, representing growth of 68% compared to the prior-year period, driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.
•Sales of TEVIMBRA totaled $191 million in the third quarter of 2025, representing growth of 17% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the third quarter of 2025 was 85.9% compared to 82.8% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in our portfolio. Gross margin also benefited from production productivity improvements for both BRUKINSA and TEVIMBRA. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 86.3% for the third quarter of 2025, compared to 84.9% in the prior-year period.
Operating Expenses
The following table summarizes operating expenses for the third quarter of 2025:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q3 2025 Q3 2024 % Change Q3 2025 Q3 2024 % Change
Research and development $ 523,662 $ 496,179 6 % $ 445,904 $ 405,545 10 %
Selling, general and administrative $ 528,998 $ 455,223 16 % $ 434,484 $ 380,737 14 %
Total operating expenses $ 1,052,660 $ 951,402 11 % $ 880,388 $ 786,282 12 %
The following table summarizes operating expenses for the year-to-date period ended September 30, 2025 and 2024:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q3 YTD 2025 Q3 YTD 2024 % Change Q3 YTD 2025 Q3 YTD 2024 % Change
Research and development $ 1,530,445 $ 1,411,283 8 % $ 1,311,156 $ 1,193,494 10 %
Selling, general and administrative $ 1,526,199 $ 1,326,379 15 % $ 1,271,650 $ 1,116,805 14 %
Total operating expenses $ 3,056,644 $ 2,737,662 12 % $ 2,582,806 $ 2,310,299 12 %
Research and Development (R&D) Expenses increased for the third quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage, and offset by lower development upfront and milestone fees. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $0.2 million and $5 million in the third quarter of 2025 and 2024, respectively.
Selling, General and Administrative (SG&A) Expenses increased for the third quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment in global commercial expansion, primarily in the U.S. and Europe. SG&A expenses as a percentage of product sales were 38% for the third quarter of 2025, compared to 46% in the prior-year period.
Net Income/(Loss) and GAAP/Non-GAAP Earnings Per Share
GAAP net income for the third quarter of 2025 was $125 million, an increase of $246 million over the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.
For the third quarter of 2025, basic and diluted earnings per share was $0.09 and $0.08 per share and $1.13 and $1.09 per American Depositary Share (ADS), respectively, compared to basic loss of $0.09 per share and $1.15 per ADS in the prior-year period.
Free Cash Flow for the third quarter of 2025 was $354 million, an increase of $300 million over the prior-year period.
For further details on BeOne’s Third Quarter 2025 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the third quarter of 2025 filed with the U.S. Securities and Exchange Commission.
Full Year 2025 Guidance
BeOne has updated its full year 2025 revenue and expense guidance. Guidance is summarized below:
Prior FY 2025 Guidance1
Current FY 2025 Guidance1
Total Revenue $5.0 – $5.3B $5.1 – $5.3B
GAAP Operating Expenses
(R&D and SG&A) $4.1 – $4.4B $4.1 – $4.3B
GAAP Gross Margin % Mid to high -80% range Unchanged
GAAP Operating Income Positive FY 2025 Unchanged
Cash Flow Positive FY 2025 free
cash flow Unchanged
1 Does not assume any potential new, material business development activity or unusual/non-recurring items. Assumes September 30, 2025, foreign exchange rates.
BeOne’s total revenue guidance for full year 2025 of $5.1 billion to $5.3 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 mid- to high-80% range due to mix and production efficiencies as compared to 2024. BeOne’s 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. Non-GAAP operating expenses, which exclude costs related to share-based compensation, depreciation and amortization expense, are expected to track with GAAP operating expenses, with reconciling items unchanged from existing practice. Operating expense guidance does not assume any potential new, material business development activity or unusual/non-recurring items.
Third Quarter Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•Approved in 75 markets globally with reimbursement in 57 markets.
•Received European Commission (EC) approval of a film-coated tablet formulation of for all approved indications; launched tablet formulation in the U.S.
TEVIMBRA (tislelizumab)
•Approved in 47 markets globally with reimbursement in 16 markets.
•Received EC approval in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by TEVIMBRA monotherapy as adjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
•Achieved first subject enrolled in Phase 3 trial for subcutaneous formulation for the treatment of first-line gastric cancer (GC).
•Achieved submission in Japan for the treatment of first-line GC.
Select Clinical-Stage Programs
Hematology
•Sonrotoclax (BCL2 inhibitor):
◦Received FDA Breakthrough Therapy Designation as a treatment for adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
◦Completed enrollment of Phase 2 trial for the treatment of adult patients with R/R Waldenstrom’s macroglobulinemia (WM), which is potentially registration enabling.
•BGB-16673 (BTK CDAC):
◦Achieved first subject enrolled in global Phase 3 head-to-head study versus noncovalent BTK inhibitor pirtobrutinib for the treatment of adult patients with R/R CLL.
Breast/Gynecologic Cancers
•BC-C9074 (B7-H4 ADC): Achieved proof-of-concept.
Lung Cancer
•BG-58067 (MTA-cooperative PRMT5 inhibitor): Achieved proof-of-concept.
•Tarlatamab (AMG 757): Achieved first subject enrolled in global Phase 3 trial for the treatment of first-line extensive-stage small cell lung cancer.
GI Cancers
•BGB-B2033 (GPC3x41BB bispecific antibody): Achieved proof-of-concept.
Inflammation & Immunology
•BGB-45035 (IRAK4 CDAC):
◦Achieved proof-of-concept for target tissue degradation in healthy volunteers.
◦Achieved first subject enrolled in Phase 2 trial for the treatment of moderate to severe rheumatoid arthritis.
•BGB-16673:Achieved first subject enrolled in Phase 1b trial for the treatment of chronic spontaneous urticaria.
Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•Orphan Drug Designation and regulatory submission in Japan for the treatment of marginal zone lymphoma.
1H 2026
TEVIMBRA
•Anticipate Japan approval for the treatment of first-line gastric cancer.
2H 2026
Hematology
•Sonrotoclax (BCL2 inhibitor):
◦Initiate enrollment of Phase 3 trial in combination with BRUKINSA versus acalabrutinib+venetoclax (AV).
1H 2026
◦Initiate enrollment in Phase 3 trial for the treatment of multiple myeloma.
2H 2026
•BGB-16673 (BTK CDAC):
◦Data readout for potential accelerated approval submission for the treatment of R/R CLL.
1H 2026
Breast/Gynecologic Cancers
•BGB-43395 (CDK4 inhibitor):
◦Initiate Phase 3 trial for the treatment of first-line HR-positive, HER2-negative metastatic breast cancer.
1H 2026
GI Cancers
•Zanidatamab (HER2-targeting bispecific antibody) for the treatment of first-line HER2-positive gastroesophageal adenocarcinoma:
◦Readout of primary progression-free survival data from Phase 3 trial (Herizon GEA-301) in collaboration with Zymeworks/Jazz.
2H 2025
Inflammation and Immunology
•BGB-45035 (IRAK4 CDAC):
◦Initiate Phase 2 trial for the treatment of atopic dermatitis.
1H 2026
Other Highlights
•Entered into an agreement with Royalty Pharma to sell royalty rights on the worldwide sales, excluding China, of Amgen’s IMDELLTRA (tarlatamab-dlle) for up to $950 million.
•Announced Pharmacyclics’ decision not to appeal a U.S. Patent and Trademark Office Final Written Decision invalidating all claims of Pharmacyclics’ U.S. Patent No. 11,672,803 related to BRUKINSA, which fully resolved the patent infringement lawsuit brought by Pharmacyclics.
Conference Call and Webcast
The Company’s earnings conference call for the third quarter 2025 will be broadcast via webcast at 8:00 a.m. ET on Thursday, November 6, 2025, 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 and a replay of the webcast will also be available.
(Press release, BeOne Medicines, NOV 6, 2025, View Source [SID1234659553])