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

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

“These strong second-quarter results underscore our continued growth as a global oncology leader. Our foundational hematology franchise, led by BRUKINSA, continues to gain momentum as we advance one of the industry’s deepest and most diverse pipelines. With differentiated capabilities spanning drug discovery, clinical development, manufacturing, and commercialization, we are well positioned for our next phase of global growth.”

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

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*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.

Second Quarter 2026 Financial Results

Product Revenue totaled $1.7 billion for the second quarter of 2026, representing growth of 29% compared to the prior-year period.

· BRUKINSA: Global sales totaled $1.2 billion for the second quarter of 2026, representing growth of 31% compared to the prior-year period; U.S. sales of BRUKINSA totaled $893 million in the second quarter of 2026, representing growth of 31% compared to the prior-year period.

· TEVIMBRA (tislelizumab): Global sales totaled $229 million in the second quarter of 2026, representing growth of 18% compared to the prior-year period.

· Amgen in-licensed products: Global sales totaled $157 million in the second quarter of 2026, representing growth of 25% compared to the prior-year period.

Gross Margin as a percentage of global product sales for the second quarter of 2026 was 90%, compared to 87% 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.

Operating Expenses

The following table summarizes operating expenses for the second quarter of 2026:

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Research and Development (R&D) Expenses increased for the second 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. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $23.3 million and $0.5 million in the second quarter of 2026 and 2025, respectively.

Selling, General and Administrative (SG&A) Expenses increased for the second quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support commercial growth. SG&A expenses as a percentage of product sales were 35% for the second quarter of 2026, compared to 41% in the prior-year period.

Net Income and Basic/Diluted Earnings Per Share

GAAP net income for the second quarter of 2026 was $237 million, an increase of $143 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage. Adjusted net income was $444 million, an increase of $192 million over the prior-year period.

For the second quarter of 2026, basic and diluted earnings per share were both $0.16 per share and $2.12 and $2.05 per American Depositary Share (ADS), respectively, compared to basic and diluted earnings per share of $0.07 and $0.06 per share and $0.87 and $0.84 per ADS in the prior-year period. On an adjusted basis, basic and diluted earnings per share was $0.31 and $0.30 per share and $3.98 and $3.84 per ADS, respectively, compared to $0.18 and $0.17 per share and $2.33 and $2.25 per ADS in the prior-year period.

Free Cash Flow for the second quarter of 2026 was $435 million, representing an increase of $216 million over the prior-year period.

For further details on BeOne’s Second Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the second quarter of 2026 filed with the U.S. Securities and Exchange Commission.

Updated Full Year 2026 Guidance

BeOne’s financial guidance is summarized below:

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BeOne’s total revenue guidance for full year 2026 of $6.6 billion to $6.8 billion includes expectations for strong revenue growth driven by BRUKINSA’s leadership position in the U.S. 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.

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. See Form 10-Q for additional updates on income tax uncertainties.

· Diluted ADS outstanding: The Company expects diluted ADSs outstanding of approximately 118 million.

Second Quarter 2026 Business Highlights

Core Marketed Products

BRUKINSA (zanubrutinib)

· Achieved positive topline results from the Phase 3 MANGROVE study in combination with rituximab demonstrating unprecedented progression-free survival (PFS) superiority versus bendamustine plus rituximab in adult patients with previously untreated mantle cell lymphoma (MCL).

· Reported long-term 78-month follow-up data from the Phase 3 SEQUOIA study, which continue to demonstrate sustained PFS benefit for the treatment of adult patients with treatment-naïve chronic lymphocytic leukemia (CLL), at the American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) annual meetings.

BEQALZI (sonrotoclax)

· Received U.S. Food and Drug Administration (FDA) accelerated approval for the treatment of adult patients with relapsed or refractory (R/R) MCL, after at least two lines of systemic therapy, including a BTK inhibitor.

TEVIMBRA (tislelizumab)

· Achieved Japan regulatory approval for the treatment of adult patients with first-line gastric cancer.

ZIIHERA (zanidatamab)

· Announced New England Journal of Medicine publication of full results from the Phase 3 HERIZON-GEA-01 study plus chemotherapy, with and without TEVIMBRA, versus trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ gastroesophageal adenocarcinoma (GEA).

Select Clinical-Stage Programs

Hosted an investor event at ASCO highlighting proof-of-concept data for three solid tumor programs, including BGB-43395 (CDK4 inhibitor), BGB-B2033 (GPC3x4-1BB bispecific antibody), and BG-C9074 (B7-H4 antibody-drug conjugate).

Hematology

· Tacabrutideg (BTK CDAC): Achieved last patient enrolled for Phase 3 CaDAnCe-303 (China-only) study (BGB-16673-303) in post-BTKi R/R CLL.

· BG-75202 (KAT6 A/B inhibitor): Achieved first patient enrolled into monotherapy cohort for Phase 1 study for the treatment of adult patients with acute myeloid leukemia.

Breast and Gynecological Cancers

· BGB-43395 (CDK4 inhibitor): Initiated Phase 3 study in combination with letrozole for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer.

Gastrointestinal Cancers

· BGB-58067 (MTA-cooperative PRMT5 inhibitor): Received U.S. FDA Orphan Drug Designation for the treatment of adult patients with pancreatic ductal adenocarcinoma.

Lung Cancer

· BON-110 (PD-1xVEGF-AxCTLA-4 trispecific antibody)1: Initiated first-in-human study.

Anticipated R&D Milestones

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Corporate Updates

· Announced a $300 million expansion of the Company’s flagship clinical and commercial-stage manufacturing and research and development center at the Princeton West Innovation Campus in Hopewell, New Jersey, to add small molecule manufacturing capabilities.

· Appointed Felix J. Baker, Ph.D.; Elizabeth F. Mooney; and Charles L. Sawyers, M.D., to the Company’s Board of Directors.

BeOne’s Earnings Results Webcast

The Company’s earnings conference call for the second quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, August 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 growth as a global oncology leader; BeOne’s pipeline catalysts; BeOne’s full year 2026 guidance; 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.

Condensed Consolidated Statements of Operations (U.S. GAAP)

(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data)

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Note Regarding Use of Non-GAAP Financial Measures

BeOne provides certain non-GAAP financial measures, including Adjusted Operating Expenses, Adjusted Operating Loss, 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.

RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES

(Amounts in thousands of U.S. Dollars, except for per share and per ADS data)

(unaudited)

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* BeOne has entered into an exclusive option with Huahui Health to license worldwide rights to HH160 (BON-110), a novel trispecific antibody targeting PD-1, VEGF-A and CTLA-4.

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