On November 5, 2026 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the third quarter of 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:

"Our strong third quarter results and raised full-year guidance reflect continued rapid global growth and leadership in hematology, anchored by our foundational BTK inhibitor BRUKINSA, which drives powerful and sustained responses in patients, and now joined by our next-generation BCL2 inhibitor BEQALZI. We look forward to multiple catalysts in the coming months from one of the deepest pipelines in oncology, spanning hematology and solid tumors, accelerated by our differentiated capabilities in R&D, manufacturing, and commercialization."

(Amounts in thousands of U.S. dollars and unaudited)

Three Months Ended Nine Months Ended
September 30, September 30,
2026 2025 % Change 2026 2025 % Change
Net product revenues $ 1,855,057 $ 1,395,013 33 % $ 5,022,180 $ 3,805,619 32 %
Other revenue $ 34,758 $ 17,271 101 % $ 86,144 $ 39,244 120 %
Total revenue $ 1,889,815 $ 1,412,284 34 % $ 5,108,324 $ 3,844,863 33 %
GAAP income from operations $ 418,675 $ 163,114 157 % $ 993,624 $ 262,101 279 %
Adjusted income from operations* $ 612,226 $ 341,184 79 % $ 1,529,649 $ 755,486 102 %
GAAP net income $ 384,706 $ 124,841 208 % $ 849,070 $ 220,431 285 %
Adjusted net income* $ 538,735 $ 303,663 77 % $ 1,358,274 $ 692,622 96 %
GAAP basic EPS per ADS $ 3.38 $ 1.13 199 % $ 7.58 $ 2.03 273 %
Adjusted basic EPS per ADS* $ 4.74 $ 2.76 72 % $ 12.12 $ 6.38 90 %
GAAP diluted EPS per ADS $ 3.28 $ 1.09 201 % $ 7.30 $ 1.96 272 %
Adjusted diluted EPS per ADS* $ 4.59 $ 2.65 73 % $ 11.68 $ 6.14 90 %
Free Cash Flow* $ 473,532 $ 354,469 34 % $ 1,069,423 $ 561,916 90 %

Third Quarter 2026 Financial Results
Product Revenue totaled $1.9 billion for the third quarter of 2026, representing growth of 33% compared to the prior-year period.
•BRUKINSA: Global sales totaled $1.4 billion for the third quarter of 2026, representing growth of 34% compared to the prior-year period; U.S. sales of BRUKINSA totaled $1.0 billion in the third quarter of 2026, representing growth of 36% compared to the prior-year period.
•TEVIMBRA (tislelizumab): Global sales totaled $243 million in the third quarter of 2026, representing growth of 28% compared to the prior-year period.
•Amgen in-licensed products: Global sales totaled $167 million in the third quarter of 2026, representing growth of 26% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the third quarter of 2026 was 88%, compared to 86% 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 the Company’s portfolio. Gross margin also benefited from productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA, which was offset by a non-cash intangible asset impairment charge of $22 million associated with our decision to discontinue promotion of POBEVCY. On an adjusted basis, which does not include depreciation and amortization, or the impairment charge, gross margin as a percentage of product sales increased to 90%, from 86% in the comparable period of the prior year.
Operating Expenses
The following table summarizes operating expenses for the third quarter of 2026:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q3 2026 Q3 2025 % Change Q3 2026 Q3 2025 % Change
Research and development $ 660,784 $ 523,662 26 % $ 586,168 $ 445,904 31 %
Selling, general and administrative $ 593,460 $ 528,998 12 % $ 503,719 $ 434,484 16 %
Total operating expenses $ 1,254,244 $ 1,052,660 19 % $ 1,089,887 $ 880,388 24 %

The following table summarizes operating expenses for the year-to-date period ended September 30, 2026, and 2025:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q3 YTD 2026 Q3 YTD 2025 % Change Q3 YTD 2026 Q3 YTD 2025 % Change
Research and development $ 1,814,288 $ 1,530,445 19 % $ 1,586,022 $ 1,311,156 21 %
Selling, general and administrative $ 1,741,771 $ 1,526,199 14 % $ 1,476,386 $ 1,271,650 16 %
Total operating expenses $ 3,556,059 $ 3,056,644 16 % $ 3,062,408 $ 2,582,806 19 %

Research and Development (R&D) Expenses increased for the third quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to advancing early clinical programs into late stage and preclinical programs into the clinic.
Selling, General and Administrative (SG&A) Expenses increased for the third quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support commercial growth.
Net Income and Basic/Diluted Earnings Per Share
GAAP net income for the third quarter of 2026 was $385 million, an increase of $260 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage. Adjusted net income was $539 million, an increase of $235 million over the prior-year period.

For the third quarter of 2026, basic and diluted earnings per share were $0.26 and $0.25 per share and $3.38 and $3.28 per American Depositary Share (ADS), respectively, compared to $0.09 and $0.08 per share and $1.13 and $1.09 per ADS in the prior-year period. On an adjusted basis, basic and diluted earnings per share was $0.36 and $0.35 per share and $4.74 and $4.59 per ADS, respectively, compared to $0.21 and $0.20 per share and $2.76 and $2.65 per ADS in the prior-year period.
Free Cash Flow for the third quarter of 2026 was $474 million, representing an increase of $119 million over the prior-year period.
For further details on BeOne’s Third Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the third quarter of 2026 filed with the U.S. Securities and Exchange Commission.
Full Year 2026 Guidance
BeOne’s financial guidance is summarized below:
Prior FY 2026 Guidance
Current FY 2026 Guidance1
Total revenue $6.6B – $6.8B $6.9B – $7.0B
GAAP gross margin % High-80% range High-80% range
GAAP operating expenses2
(combined R&D and SG&A)
$4.8B – $5.0B $4.9B – $5.0B
GAAP operating income2
$1.0B – $1.1B $1.2B – $1.3B
Non-GAAP operating income2,3
$1.7B – $1.8B $1.9B – $2.0B

1 Assumes November 1, 2026 foreign exchange rates.
2 Does not assume any potential new, material business development activity or unusual/non-recurring items.
3 Non-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 $6.9 billion to $7.0 billion reflects performance through the third quarter and the Company’s expectations for the remainder of the year. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth.
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 the 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 Company continues to evaluate and assess the magnitude but expects the reversal will occur in the fourth quarter of 2026. See Form 10-Q for additional updates.
•Diluted ADS outstanding: The Company expects diluted ADSs outstanding of approximately 118 million.
Third Quarter 2026 Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•Received U.S. Food and Drug Administration (FDA) Priority Review designation for the Phase 3 MANGROVE filing.
•Completed Phase 3 MANGROVE regulatory submissions in the EU and China.
•29 abstracts accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2026 Annual Meeting, including interim analysis results from the Phase 3 MANGROVE study in first-line mantle cell lymphoma (MCL) to be presented during the Plenary Scientific Session.

BEQALZI (sonrotoclax)
•10 abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2026.
TEVIMBRA (tislelizumab)
•Received Japan regulatory approval for the treatment of adult patients with first-line nasopharyngeal cancer.

ZIIHERA (zanidatamab) for which BeOne holds commercialization rights in select markets
•Presented Phase 3 survival data reinforcing benefit of ZIIHERA-containing regimens in first-line HER2+ gastroesophageal adenocarcinoma (GEA) at the European Society for Medical Oncology Congress 2026 (ESMO 2026).
•Received U.S. Food and Drug Administration (FDA) approval for TEVIMBRA-based regimen for first-line HER2+ GEA.

Select Clinical-Stage Programs
Hematology
•6 Tacabrutideg abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2026.
•Tacabrutideg (BTK CDAC): Pivotal Phase 2 portion of CaDAnCe-101 met its primary endpoint of overall response rate in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
•BG-75202 (KAT6 A/B inhibitor): First patient enrolled into monotherapy cohort for the Phase 1 study for the treatment of adult patients with acute myeloid leukemia.
Gastrointestinal Cancers
•BGB-B2033 (GPC3x4-1BB bispecific antibody):
◦Updated data presented at ESMO (Free ESMO Whitepaper) 2026.
◦Received Orphan Drug Designation from the European Commission and awarded Innovation Passport, enabling entry to the UK’s Innovative Licensing and Access Pathway, in hepatocellular carcinoma (HCC).
•BG-85738 (RAS ONi): First patient enrolled in the Phase 1 study of advanced solid tumors with RAS mutations.
Lung Cancer
•BG-C477 (CEA ADC):
◦Disclosed first clinical data at ESMO (Free ESMO Whitepaper) 2026.
◦Received FDA Fast Track Designation for the treatment of patients with advanced or metastatic CEA-high non-small cell lung cancer whose disease has progressed following prior systemic therapy.
•BGB 58067 (MTA-cooperative PRMT5 inhibitor): Disclosed first clinical data at ESMO (Free ESMO Whitepaper) 2026.

Breast and Gynecological Cancers
•BG-C9074 (B7-H4 ADC): Initiated Starstone-301 Phase 3 study in combination with bevacizumab for the treatment of adult patients with first-line ovarian cancer in maintenance setting.

Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•Regulatory submission in Japan for the treatment of adult patients with first-line MCL.
Q4 2026
TEVIMBRA
•China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy.
1H 2027
ZIIHERA
•China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA.
1H 2027
Tacabrutideg(BGB-16673)
•Phase 2 potential submission for the treatment of adult patients with R/R CLL.
Mid 2027
•CaDAnCe-306: Phase 3 study initiation for R/R CLL in combination with BEQALZI
1H 2027
BGB-B2033
(GPC3x4-1BB bispecific antibody)
•GroundBBreaker-301 Phase 3 study initiation in second-line or later hepatocellular carcinoma.
Q4 2026
•GroundBBreaker-201 potentially pivotal single-arm Phase 2 study initiation in second-line or later hepatocellular carcinoma.
Q4 2026
•GroundBBreaker-302 pivotal Phase 3 study initiation in first-line hepatocellular carcinoma
1H 2027

Corporate Updates
•Announced a multi-part collaboration with Revolution Medicines, including a clinical collaboration to evaluate drug combinations incorporating select clinical-stage oncology assets from BeOne with any of Revolution Medicines’ four clinical RAS(ON) inhibitors, and a separate regional rights agreement granting BeOne exclusive development and commercialization rights to these Revolution Medicines assets in select Asian markets.

•Announced a voluntary agreement with the U.S. Government to expand access to innovative cancer medicines for American patients while strengthening the Company’s U.S manufacturing footprint.
•Announced the renewal of a partnership with the BeOne Care Foundation and The Max Foundation, a leading global health nonprofit organization, to expand access to BRUKINSA for the treatment of adult patients with CLL in low- and middle-income countries through 2028.

BeOne’s Earnings Results Webcast

The Company’s earnings conference call for the third quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Thursday, November 5, 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, NOV 5, 2026, View Source [SID1234674298])