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BeOne Medicines Announces Second Quarter 2025 Financial Results and Business Updates

• Second quarter total revenues increased 42% to $1.3 billion versus second quarter 2024
• Global BRUKINSA revenues increased 49% to $950 million versus second quarter 2024
• Reported diluted GAAP Earnings per American Depositary Share (ADS) of $0.84, non-GAAP diluted Earnings per ADS of $2.25
• Anticipate 20+ milestones in next 18 months across hematology and solid tumor pipeline

SAN CARLOS, Calif.--(BUSINESS WIRE)-- (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the second quarter of 2025.

鈥淥ur strong second quarter performance reinforces our trajectory as a global oncology powerhouse and underscores our proven ability to deliver sustainable, long-term growth,鈥� said John V. Oyler, Co-Founder, Chairman and CEO of BeOne. 鈥淲e are executing with purpose and advancing our mission to deliver transformative medicines to more patients worldwide. BRUKINSA, the backbone of our hematology franchise, continues to set the standard as the best-in-class BTK inhibitor with the most approved indications and market leader in the US, a position earned from superior efficacy, favorable safety, and positive patient outcomes across its five indications. Building on this momentum, our two additional Phase 3 hematology assets, BCL2 inhibitor sonrotoclax and BTK CDAC BGB-16673, have the potential to further expand our franchise leadership with pivotal data readouts and new trial initiations anticipated in the near-term. At our recent Investor R&D Day, we outlined a bold path forward with more than 20 expected R&D milestones in the next 18 months. This includes potentially promising advances across our expansive solid tumor pipeline, where we are building future global franchises targeting a range of highly prevalent cancers.鈥�

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

Second Quarter 2025 Financial Results

Revenue for the second quarter of 2025 was $1.3 billion, compared to $929 million in the prior-year period driven primarily by growth in BRUKINSA (zanubrutinib) product sales in the U.S. and Europe.

Product Revenue totaled $1.3 billion for the second quarter of 2025 compared to $921 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鈥檚 largest market, with product revenue of $685 million compared to $479 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 $684 million in the second quarter of 2025, representing growth of 43% 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 $150 million in the second quarter of 2025, representing growth of 85% 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 $194 million in the second quarter of 2025, representing growth of 22% compared to the prior-year period.

Gross Margin as a percentage of global product sales for the second quarter of 2025 was 87.4% compared to 85.0% 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 cost of sales 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 88.1% for the second quarter of 2025, compared to 85.4% in the prior-year period.

Operating Expenses

The following table summarizes operating expenses for the second quarter of 2025:

The following table summarizes operating expenses for the first half of 2025:

Research and Development (R&D) Expenses increased for the second 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 $0.5 million and $12 million in the second quarter of 2025 and 2024, respectively.

Selling, General and Administrative (SG&A) Expenses increased for the second 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 41% for the second quarter of 2025, compared to 48% in the prior-year period.

Net Income/(Loss) and GAAP/Non-GAAP Earnings Per Share

GAAP net income for the second quarter of 2025 was $94 million, an increase of $215 million over the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.

For the second quarter of 2025, basic and diluted earnings per share was $0.07 and $0.06 per share and $0.87 and $0.84 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 second quarter of 2025 was $220 million, an increase of $425 million over the prior-year period.

For further details on BeOne鈥檚 Second Quarter 2025 Financial Statements, please see BeOne鈥檚 Quarterly Report on Form 10-Q for the second quarter of 2025 filed with the U.S. Securities and Exchange Commission.

Full Year 2025 Guidance

BeOne has updated its full year 2025 revenue guidance and maintained its expense guidance. Guidance is summarized below:

BeOne鈥檚 total revenue guidance for full year 2025 of $5.0 billion to $5.3 billion includes expectations for strong revenue growth driven by BRUKINSA鈥檚 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鈥檚 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.

Second Quarter Business Highlights

Core Marketed Products

BRUKINSA (zanubrutinib)

• BRUKINSA is now approved in 75 markets globally with five new or expanded reimbursements in the quarter.
• Received U.S. Food and Drug Administration (FDA) approval and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of a new film-coated tablet formulation for all approved indications.

TEVIMBRA (tislelizumab)

• TEVIMBRA is now approved in 47 markets globally with 20 new reimbursements in the quarter, including in Japan, Europe and Australia.
• Received European Commission (EC) approval in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma.
• Received EC approval for the treatment of first-line extensive-stage small cell lung cancer.
• Received a positive CHMP opinion recommending approval of TEVIMBRA in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
• Received FDA approval of alternative dosing regimens of 150 Q2W and 300 Q4W for the treatment of first-line gastric cancer and second-line esophageal squamous cell carcinoma.

Select Clinical-Stage Programs

Hematology

• Sonrotoclax (BCL2 inhibitor):

• Achieved acceptance of submissions in China with priority reviews for the treatment of relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R mantle cell lymphoma (MCL).
• Achieved first subject enrolled in global Phase 3 trial in combination with CD20 antibody for the treatment of R/R CLL.
  

• BGB-16673 (BTK CDAC):

• Received EMA PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom鈥檚 macroglobulinemia (WM) previously treated with a BTK inhibitor.
• Achieved first subject enrolled for global Phase 3 BGB-16673-302 trial for the treatment of R/R CLL.
• Achieved first subject enrolled for China Phase 3 BGB-16673-303 trial for the treatment of R/R/ CLL.
• Initiated enrollment of potentially registration enabling Phase 2 trial for the treatment of R/R WM.

Lung Cancer

• Tarlatamab (AMG 757):
  • Achieved acceptance of BLA and priority review in China for the treatment of 3L+ small cell lung cancer (SCLC).
  • Achieved acceptance of BLA in China for the treatment of 2L SCLC.

GI Cancers

• Zanidatamab (HER2-targeting bispecific antibody): Received regulatory approval and achieved commercial launch in China for the treatment of second-line HER2-high-expression biliary tract cancer.

Inflammation & Immunology

• BGB-45035 (IRAK4 CDAC): Achieved first subject enrolled in Phase 1b trial for the treatment of atopic dermatitis and prurigo nodularis.
• BGB-16673 (BTK CDAC): Achieved first subject enrolled in Phase 1 trial for the treatment of chronic spontaneous urticaria.

Anticipated R&D Milestones

Other Highlights

• Completed renaming to BeOne Medicines Ltd., and redomiciliation to Switzerland.

Conference Call and Webcast

The Company鈥檚 earnings conference call for the second quarter 2025 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, August 6, 2025, and will be accessible through the Investors section of BeOne鈥檚 website at . Supplemental information in the form of a slide presentation and a replay of the webcast will also be available.

About BeOne

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to 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. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

To learn more about BeOne, please visit and follow us on , , and .

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: upcoming R&D milestones to be achieved by BeOne; the timing of clinical developments and data readouts; BeOne鈥檚 expectations regarding continued global expansion and investment to support growth; BeOne鈥檚 ability to bring transformative medicines to more patients worldwide; BeOne鈥檚 future revenue, operating income, cash flow, free cash flow, operating expenses, and gross margin percentage; and BeOne鈥檚 plans, commitments, aspirations and goals under the caption 鈥淎bout BeOne鈥�. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne鈥檚 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鈥檚 ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne鈥檚 ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne鈥檚 reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne鈥檚 limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne鈥檚 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 鈥淩isk Factors鈥� in BeOne鈥檚 most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne鈥檚 subsequent filings with the U.S. Securities and Exchange Commission. 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鈥檚 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 Operating Expenses, Adjusted Operating Loss, Adjusted Net Income, Adjusted Earnings Per Share 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鈥檚 operating performance. Adjustments to BeOne鈥檚 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鈥檚 operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of BeOne鈥檚 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鈥檚 management uses for planning and forecasting purposes and measuring BeOne鈥檚 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.

1. Tax effect of Non-GAAP adjustments is based on the statutory tax rate in the relevant tax jurisdiction. Please note that the Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects.
2. For the second quarter of 2024, GAAP diluted loss per ADS includes $0.02 loss per ADS attributable to the dilutive ADS outstanding for purposes of this reconciliation. As the Company was in a GAAP net loss position no diluted weighted average shares outstanding were calculated for US GAAP purposes.

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Source: BeOne Medicines Ltd.