BeOne Medicines Announces Third Quarter 2026 Financial Results and Business Updates

• Total global revenues of $1.9 billion for the third quarter, an increase of 34% from the prior year
• BRUKINSA (zanubrutinib) global revenues of $1.4 billion for the third quarter, an increase of 34% from the prior year
• Diluted GAAP Earnings per American Depository Share (ADS) of $3.28 for the third quarter; non-GAAP diluted Earnings per ADS of $4.59 for the third quarter
• Raised 2026 total revenue guidance to $6.9 to $7.0 billion; GAAP operating income of $1.2 to $1.3 billion, non-GAAP operating income of $1.9 to $2.0 billion

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

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.”

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:

The following table summarizes operating expenses for the year-to-date period ended September 30, 2026, and 2025:

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:

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) 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 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 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 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 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 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

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.

About BeOne

BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

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: BeOne’s continued rapid global growth and leadership in hematology; future catalysts for BeOne’s business; BeOne’s full year 2026 guidance; BeOne’s expectations regarding certain valuation allowances; BeOne’s expectations regarding continued global expansion and investment to support growth; upcoming R&D milestones to be achieved by BeOne; the timing of clinical and regulatory developments and data readouts; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’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; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’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 BeOne’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”), as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties.

Note Regarding Use of Non-GAAP Financial Measures

BeOne provides certain non-GAAP financial measures, including Adjusted Cost of Sales- Product, Adjusted Operating Expenses, Adjusted Income from Operations, Adjusted Income Tax Expense, Adjusted Net Income, Adjusted Earnings Per Share, Free Cash Flow 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 BeOne’s operating performance. Adjustments to BeOne’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. Non-GAAP adjustments are tax effected to the extent there is U.S. GAAP current tax expense. The Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects. BeOne 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. BeOne believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeOne’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of BeOne’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 BeOne’s management uses for planning and forecasting purposes and measuring BeOne’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 BeOne may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies.

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