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Business Upturn
06-08-2025
- Business
- Business Upturn
BeOne Medicines Announces Second Quarter 2025 Financial Results and Business Updates
By Business Wire India Published on August 6, 2025, 18:56 IST Business Wire India 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 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 2025. 'Our strong second quarter performance reinforces our trajectory as a global oncology powerhouse and underscores our proven ability to deliver sustainable, long-term growth,' said John V. Oyler, Co-Founder, Chairman and CEO of BeOne. 'We 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.' (Amounts in thousands of U.S. dollars and unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 % Change 2025 2024 % Change Net product revenues $ 1,302,076 $ 921,146 41 % $ 2,410,606 $ 1,668,064 45 % Net revenue from collaborations $ 13,224 $ 8,020 65 % $ 21,973 $ 12,754 72 % Total revenue $ 1,315,300 $ 929,166 42 % $ 2,432,579 $ 1,680,818 45 % GAAP income (loss) from operations $ 87,885 $ (107,161 ) 182 % $ 98,987 $ (368,509 ) 127 % Adjusted income (loss) from operations* $ 274,945 $ 48,464 467 % $ 414,302 $ (98,877 ) 519 % GAAP net income (loss) $ 94,320 $ (120,405 ) 178 % $ 95,590 $ (371,555 ) 126 % Adjusted net income (loss)* $ 252,822 $ 23,294 985 % $ 388,959 $ (122,602 ) 417 % GAAP basic EPS per ADS $ 0.87 $ (1.15 ) 176 % $ 0.89 $ (3.56 ) 125 % Adjusted basic EPS per ADS* $ 2.33 $ 0.22 959 % $ 3.61 $ (1.17 ) 409 % GAAP diluted EPS per ADS $ 0.84 $ (1.15 ) 173 % $ 0.85 $ (3.56 ) 124 % Adjusted diluted EPS per ADS* $ 2.25 $ 0.22 923 % $ 3.48 $ (1.17 ) 397 % Free Cash Flow* $ 219,772 $ (205,538 ) 207 % $ 207,447 $ (670,688 ) 131 % * 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 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's 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: GAAP Non-GAAP (unaudited, in thousands, except percentages) Q2 2025 Q2 2024 % Change Q2 2025 Q2 2024 % Change Research and development $ 524,896 $ 454,466 15 % $ 444,057 $ 382,509 16 % Selling, general and administrative $ 537,913 $ 443,729 21 % $ 441,655 $ 363,922 21 % Total operating expenses $ 1,062,809 $ 898,195 18 % $ 885,712 $ 746,431 19 % The following table summarizes operating expenses for the first half of 2025: GAAP Non-GAAP (unaudited, in thousands, except percentages) Q2 YTD 2025 Q2 YTD 2024 % Change Q2 YTD 2025 Q2 YTD 2024 % Change Research and development $ 1,006,783 $ 915,104 10 % $ 865,252 $ 787,949 10 % Selling, general and administrative $ 997,201 $ 871,156 14 % $ 837,166 $ 736,068 14 % Total operating expenses $ 2,003,984 $ 1,786,260 12 % $ 1,702,418 $ 1,524,017 12 % 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's Second Quarter 2025 Financial Statements, please see BeOne's 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: Prior FY 2025 Guidance1 Current FY 2025 Guidance1 Total Revenue $4.9 – $5.3B $5.0 – $5.3B GAAP Operating Expenses (R&D and SG&A) $4.1 – $4.4B $4.1 – $4.4B GAAP Gross Margin % Mid-80% range Mid to high-80% range GAAP Operating Income Positive FY 2025 Positive FY 2025 Cash Flow Positive FY 2025 cash flow from operations Positive FY 2025 free cash flow 1 Does not assume any potential new, material business development activity or unusual/non-recurring items. Assumes June 30, 2025 foreign exchange rates. BeOne's total revenue guidance for full year 2025 of $5.0 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. 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. Received EMA PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom's 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 Programs Milestones Timing BRUKINSA EC approval of tablet formulation. Interim analysis of Phase 3 MANGROVE trial for the treatment of treatment-naïve MCL. 2H 2025 2H 2025 TEVIMBRA EU approval for the treatment of neoadjuvant and adjuvant early stage NSCLC. Initiate Phase 3 trial for subcutaneous formulation. 2H 2025 2H 2025 Hematology Sonrotoclax: Data readout of Phase 2 trial and potential global accelerated approval submissions for the treatment of R/R MCL. BGB-16673: Initiate Phase 3 head-to-head trial compared to noncovalent BTK inhibitor pirtobrutinib for the treatment of R/R CLL. 2H 2025 2H 2025 Breast Cancer BGB-43395 (CDK4 inhibitor): Initiate Phase 3 trial for the treatment of second-line hormone receptor-positive, HER2-negative metastatic breast cancer. Initiate Phase 3 trial for the treatment of first-line hormone receptor-positive, HER2-negative metastatic breast cancer. 2026 2026 Lung Cancer BGB-58067 (PRMT5 inhibitor) and BG-89894 (MAT2A inhibitor): Anticipate first subject enrolled in combination trial. 2H 2025 GI Cancers Zanidatamab (HER2-targeting bispecific antibody): Readout of primary progression-free survival data from Phase 3 trial in collaboration with Zymeworks/Jazz for the treatment of first-line HER2-positive gastroesophageal adenocarcinoma. 2H 2025 Inflammation and Immunology BGB-45035 (IRAK4 CDAC): Anticipate first subject enrolled in Phase 2 trials. Proof-of-concept data for tissue IRAK4 degradation. 2H 2025 2H 2025 Other Highlights Completed renaming to BeOne Medicines Ltd., and redomiciliation to Switzerland. Conference Call and Webcast The Company's 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's 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 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: upcoming R&D milestones to be achieved by BeOne; the timing of clinical developments and data readouts; BeOne's expectations regarding continued global expansion and investment to support growth; BeOne's ability to bring transformative medicines to more patients worldwide; BeOne's future revenue, operating income, cash flow, free cash flow, operating expenses, and gross margin percentage; 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 quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's 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'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) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 (Unaudited) (Unaudited) Revenues Product revenue, net $ 1,302,076 $ 921,146 $ 2,410,606 $ 1,668,064 Collaboration revenue 13,224 8,020 21,973 12,754 Total revenues 1,315,300 929,166 2,432,579 1,680,818 Cost of sales – products 164,606 138,132 329,608 263,067 Gross profit 1,150,694 791,034 2,102,971 1,417,751 Operating expenses: Research and development 524,896 454,466 1,006,783 915,104 Selling, general and administrative 537,913 443,729 997,201 871,156 Total operating expenses 1,062,809 898,195 2,003,984 1,786,260 Income (loss) from operations 87,885 (107,161 ) 98,987 (368,509 ) Interest income, net 3,497 13,225 9,345 29,385 Other income (expense), net 8,167 (11,984 ) 12,117 (10,222 ) Income (loss) before income taxes 99,549 (105,920 ) 120,449 (349,346 ) Income tax expense 5,229 14,485 24,859 22,209 Net income (loss) $ 94,320 $ (120,405 ) 95,590 (371,555 ) Earnings (loss) per share Basic $ 0.07 $ (0.09 ) 0.07 (0.27 ) Diluted $ 0.06 $ (0.09 ) 0.07 (0.27 ) Weighted-average shares outstanding—basic 1,408,166,754 1,361,082,567 1,399,159,898 1,358,315,145 Weighted-average shares outstanding—diluted 1,463,277,401 1,361,082,567 1,454,296,475 1,358,315,145 Earnings (loss) per American Depositary Share (ADS) Basic $ 0.87 $ (1.15 ) 0.89 (3.56 ) Diluted $ 0.84 $ (1.15 ) 0.85 (3.56 ) Weighted-average ADSs outstanding—basic 108,320,520 104,698,659 107,627,684 104,485,780 Weighted-average ADSs outstanding—diluted 112,559,800 104,698,659 111,868,960 104,485,780 Select Condensed Consolidated Balance Sheet Data (U.S. GAAP) (Amounts in thousands of U.S. Dollars) As of June 30, December 31, 2025 2024 (unaudited) (audited) Assets: Cash, cash equivalents and restricted cash $ 2,786,086 $ 2,638,747 Accounts receivable, net 770,776 676,278 Inventories 502,867 494,986 Property, plant and equipment, net 1,615,792 1,578,423 Total assets 6,298,394 5,920,910 Liabilities and equity: Accounts payable 360,783 404,997 Accrued expenses and other payables 908,882 803,713 R&D cost share liability 119,871 165,440 Debt 954,485 1,018,013 Total liabilities 2,527,919 2,588,688 Total equity $ 3,770, 475 $ 3,332,222 Select Unaudited Condensed Consolidated Statements of Cash Flows (U.S. GAAP) (Amounts in thousands of U.S. Dollars) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 (unaudited) (unaudited) Cash, cash equivalents and restricted cash at beginning of period $ 2,530,591 $ 2,807,436 $ 2,638,747 $ 3,185,984 Net cash provided by (used in) operating activities 263,598 (95,588 ) 307,680 (404,160 ) Net cash used in investing activities (66,605 ) (111,032 ) (188,546 ) (320,863 ) Net cash provided by financing activities 35,025 23,017 1,248 185,310 Net effect of foreign exchange rate changes 23,477 (5,902 ) 26,957 (28,340 ) Net increase (decrease) in cash, cash equivalents, and restricted cash 255,495 (189,505 ) 147,339 (568,053 ) Cash, cash equivalents and restricted cash at end of period $ 2,786,086 $ 2,617,931 $ 2,786,086 $ 2,617,931 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'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) (unaudited) Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 Reconciliation of GAAP to adjusted cost of sales – products: GAAP cost of sales – products $ 164,606 $ 138,132 $ 329,608 $ 263,067 Less: Depreciation 3,321 2,684 5,934 5,029 Less: Amortization of intangibles 5,749 1,177 6,922 2,360 Less: Other 893 — 893 — Adjusted cost of sales – products $ 154,643 $ 134,271 $ 315,859 $ 255,678 Reconciliation of GAAP to adjusted research and development: GAAP research and development $ 524,896 $ 454,466 $ 1,006,783 $ 915,104 Less: Share-based compensation cost 64,392 55,406 106,159 93,451 Less: Depreciation 16,447 16,551 35,372 33,704 Adjusted research and development $ 444,057 $ 382,509 $ 865,252 $ 787,949 Reconciliation of GAAP to adjusted selling, general and administrative: GAAP selling, general and administrative $ 537,913 $ 443,729 $ 997,201 $ 871,156 Less: Share-based compensation cost 86,161 75,288 139,845 125,957 Less: Depreciation 10,086 4,519 20,162 9,131 Less: Amortization of intangibles 11 — 28 — Adjusted selling, general and administrative $ 441,655 $ 363,922 $ 837,166 $ 736,068 Reconciliation of GAAP to adjusted operating expenses GAAP operating expenses $ 1,062,809 $ 898,195 $ 2,003,984 $ 1,786,260 Less: Share-based compensation cost 150,553 130,694 246,004 219,408 Less: Depreciation 26,533 21,070 55,534 42,835 Less: Amortization of intangibles 11 — 28 — Adjusted operating expenses $ 885,712 $ 746,431 $ 1,702,418 $ 1,524,017 Reconciliation of GAAP to adjusted income (loss) from operations: GAAP income (loss) from operations $ 87,885 $ (107,161 ) $ 98,987 $ (368,509 ) Plus: Share-based compensation cost 150,553 130,694 246,004 219,408 Plus: Depreciation 29,854 23,754 61,468 47,864 Plus: Amortization of intangibles 5,760 1,177 6,950 2,360 Plus: Other 893 — 893 — Adjusted income (loss) from operations $ 274,945 $ 48,464 $ 414,302 $ (98,877 ) Reconciliation of GAAP to adjusted net income (loss): GAAP net income (loss) $ 94,320 $ (120,405 ) $ 95,590 $ (371,555 ) Plus: Share-based compensation expenses 150,553 130,694 246,004 219,408 Plus: Depreciation 29,854 23,754 61,468 47,864 Plus: Amortization of intangibles 5,760 1,177 6,950 2,360 Plus: Other 893 — 893 — Plus: Impairment of equity investments 3,118 — 15,494 — Plus: Discrete tax items (14,210 ) 1,513 (8,737 ) 2,403 Plus: Income tax effect of non-GAAP adjustments1 (17,466 ) (13,439 ) (28,703 ) (23,082 ) Adjusted net income (loss) $ 252,822 $ 23,294 $ 388,959 $ (122,602 ) Reconciliation of GAAP to adjusted EPS – basic GAAP earnings (loss) per share – basic $ 0.07 $ (0.09 ) $ 0.07 $ (0.27 ) Plus: Share-based compensation expenses 0.11 0.10 0.18 0.16 Plus: Depreciation 0.02 0.02 0.04 0.04 Plus: Amortization of intangibles 0.00 0.00 0.00 0.00 Plus: Other 0.00 0.00 0.00 0.00 Plus: Impairment of equity investments 0.00 0.00 0.01 0.00 Plus: Discrete tax items (0.01 ) (0.00 ) (0.01 ) 0.00 Plus: Income tax effect of non-GAAP adjustments1 (0.01 ) (0.01 ) (0.02 ) (0.02 ) Adjusted earnings (loss) per share – basic $ 0.18 $ 0.02 $ 0.28 $ (0.09 ) Reconciliation of GAAP to adjusted EPS – diluted GAAP earnings (loss) per share – diluted $ 0.06 $ (0.09 ) $ 0.07 $ (0.27 ) Plus: Share-based compensation expenses 0.10 0.09 0.17 0.16 Plus: Depreciation 0.02 0.02 0.04 0.04 Plus: Amortization of intangibles 0.00 0.00 0.00 0.00 Plus: Other 0.00 0.00 0.00 0.00 Plus: Impairment of equity investments 0.00 0.00 0.01 0.00 Plus: Discrete tax items (0.01 ) 0.00 (0.01 ) 0.00 Plus: Income tax effect of non-GAAP adjustments1 (0.01 ) (0.01 ) (0.02 ) (0.02 ) Adjusted earnings (loss) per share – diluted $ 0.17 $ 0.02 $ 0.27 $ (0.09 ) Reconciliation of GAAP to adjusted earnings (loss) per ADS – basic GAAP earnings (loss) per ADS – basic $ 0.87 $ (1.15 ) $ 0.89 $ (3.56 ) Plus: Share-based compensation expenses 1.39 1.25 2.29 2.10 Plus: Depreciation 0.28 0.23 0.57 0.46 Plus: Amortization of intangibles 0.05 0.01 0.06 0.02 Plus: Other 0.01 0.00 0.01 0.00 Plus: Impairment of equity investments 0.03 0.00 0.14 0.00 Plus: Discrete tax items (0.13 ) 0.01 (0.08 ) 0.02 Plus: Income tax effect of non-GAAP adjustments1 (0.16 ) (0.13 ) (0.27 ) (0.22 ) Adjusted earnings (loss) per ADS – basic $ 2.33 $ 0.22 $ 3.61 $ (1.17 ) Reconciliation of GAAP to adjusted earnings (loss) per ADS – diluted GAAP earnings (loss) per ADS – diluted2 $ 0.84 $ (1.13 ) $ 0.85 $ (3.56 ) Plus: Share-based compensation expenses 1.34 1.23 2.20 2.10 Plus: Depreciation 0.27 0.22 0.55 0.46 Plus: Amortization of intangibles 0.05 0.01 0.06 0.02 Plus: Other 0.01 0.00 0.01 0.00 Plus: Impairment of equity investments 0.03 0.00 0.14 0.00 Plus: Discrete tax items (0.13 ) 0.01 (0.08 ) 0.02 Plus: Income tax effect of non-GAAP adjustments1 (0.16 ) (0.13 ) (0.26 ) (0.22 ) Adjusted earnings (loss) per ADS – diluted $ 2.25 $ 0.22 $ 3.48 $ (1.17 ) 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. 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. Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Free Cash Flow (Non-GAAP): Net cash provided by (used in) operating activities (GAAP) $ 263,598 $ (95,588 ) $ 307,680 $ (404,160 ) Less: Purchases of property, plant and equipment (43,826 ) (109,950 ) (100,233 ) (266,528 ) Free Cash Flow (Non-GAAP) $ 219,772 $ (205,538 ) $ 207,447 (670,688 ) View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire India. Business Upturn take no editorial responsibility for the same. Ahmedabad Plane Crash Business Wire India, established in 2002, India's premier media distribution company ensures guaranteed media coverage through its network of 30+ cities and top news agencies.
National Post
06-08-2025
- Business
- National Post
BeOne Medicines Announces Second Quarter 2025 Financial Results and Business Updates
Article content 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 Article content SAN CARLOS, Calif. — 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 2025. Article content 'Our strong second quarter performance reinforces our trajectory as a global oncology powerhouse and underscores our proven ability to deliver sustainable, long-term growth,' said John V. Oyler, Co-Founder, Chairman and CEO of BeOne. 'We 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.' Article content Second Quarter 2025 Financial Results Article content Revenue Article content 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. Article content Product Revenue Article content 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's 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. Article content 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. Article content Gross Margin Article content 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. Article content The following table summarizes operating expenses for the first half of 2025: Article content 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. Article content Selling, General and Administrative (SG&A) Expenses Article content 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. Article content Net Income/(Loss) and GAAP/Non-GAAP Earnings Per Share Article content 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. Article content 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. Article content Free Cash Flow Article content for the second quarter of 2025 was $220 million, an increase of $425 million over the prior-year period. Article content For further details on BeOne's Second Quarter 2025 Financial Statements, please see BeOne's Quarterly Report on Form 10-Q for the second quarter of 2025 filed with the U.S. Securities and Exchange Commission. Article content BeOne has updated its full year 2025 revenue guidance and maintained its expense guidance. Guidance is summarized below: Article content BeOne's total revenue guidance for full year 2025 of $5.0 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. Article content BRUKINSA Article content (zanubrutinib) Article content 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. Article content TEVIMBRA Article content (tislelizumab) Article content 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. Article content Select Clinical-Stage Programs Article content Hematology Article content Sonrotoclax (BCL2 inhibitor): Article content 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. Article content BGB-16673 (BTK CDAC): Article content Received EMA PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom's 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. Article content Lung Cancer Article content GI Cancers Article content 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. Article content Inflammation & Immunology Article content 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. Article content Anticipated R&D Milestones Article content Other Highlights Article content Completed renaming to BeOne Medicines Ltd., and redomiciliation to Switzerland. Article content Conference Call and Webcast Article content The Company's 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's website at Supplemental information in the form of a slide presentation and a replay of the webcast will also be available. Article content About BeOne Article content 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. Article content Forward-Looking Statements Article content 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's expectations regarding continued global expansion and investment to support growth; BeOne's ability to bring transformative medicines to more patients worldwide; BeOne's future revenue, operating income, cash flow, free cash flow, operating expenses, and gross margin percentage; 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 quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's 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's financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Article content Note Regarding Use of Non-GAAP Financial Measures Article content 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'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. Article content Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 Reconciliation of GAAP to adjusted cost of sales – products: GAAP cost of sales – products $ 164,606 $ 138,132 $ 329,608 $ 263,067 Less: Depreciation 3,321 2,684 5,934 5,029 Less: Amortization of intangibles 5,749 1,177 6,922 2,360 Less: Other 893 — 893 — Adjusted cost of sales – products $ 154,643 $ 134,271 $ 315,859 $ 255,678 Reconciliation of GAAP to adjusted research and development: GAAP research and development $ 524,896 $ 454,466 $ 1,006,783 $ 915,104 Less: Share-based compensation cost 64,392 55,406 106,159 93,451 Less: Depreciation 16,447 16,551 35,372 33,704 Adjusted research and development $ 444,057 $ 382,509 $ 865,252 $ 787,949 Reconciliation of GAAP to adjusted selling, general and administrative: GAAP selling, general and administrative $ 537,913 $ 443,729 $ 997,201 $ 871,156 Less: Share-based compensation cost 86,161 75,288 139,845 125,957 Less: Depreciation 10,086 4,519 20,162 9,131 Less: Amortization of intangibles 11 — 28 — Adjusted selling, general and administrative $ 441,655 $ 363,922 $ 837,166 $ 736,068 Reconciliation of GAAP to adjusted operating expenses GAAP operating expenses $ 1,062,809 $ 898,195 $ 2,003,984 $ 1,786,260 Less: Share-based compensation cost 150,553 130,694 246,004 219,408 Less: Depreciation 26,533 21,070 55,534 42,835 Less: Amortization of intangibles 11 — 28 — Adjusted operating expenses $ 885,712 $ 746,431 $ 1,702,418 $ 1,524,017 Reconciliation of GAAP to adjusted income (loss) from operations: GAAP income (loss) from operations $ 87,885 $ (107,161 ) $ 98,987 $ (368,509 ) Plus: Share-based compensation cost 150,553 130,694 246,004 219,408 Plus: Depreciation 29,854 23,754 61,468 47,864 Plus: Amortization of intangibles 5,760 1,177 6,950 2,360 Plus: Other 893 — 893 — Adjusted income (loss) from operations $ 274,945 $ 48,464 $ 414,302 $ (98,877 ) Reconciliation of GAAP to adjusted net income (loss): GAAP net income (loss) $ 94,320 $ (120,405 ) $ 95,590 $ (371,555 ) Plus: Share-based compensation expenses 150,553 130,694 246,004 219,408 Plus: Depreciation 29,854 23,754 61,468 47,864 Plus: Amortization of intangibles 5,760 1,177 6,950 2,360 Plus: Other 893 — 893 — Plus: Impairment of equity investments 3,118 — 15,494 — Plus: Discrete tax items (14,210 ) 1,513 (8,737 ) 2,403 Plus: Income tax effect of non-GAAP adjustments 1 (17,466 ) (13,439 ) (28,703 ) (23,082 ) Adjusted net income (loss) $ 252,822 $ 23,294 $ 388,959 $ (122,602 ) Reconciliation of GAAP to adjusted EPS – basic GAAP earnings (loss) per share – basic $ 0.07 $ (0.09 ) $ 0.07 $ (0.27 ) Plus: Share-based compensation expenses 0.11 0.10 0.18 0.16 Plus: Depreciation 0.02 0.02 0.04 0.04 Plus: Amortization of intangibles 0.00 0.00 0.00 0.00 Plus: Other 0.00 0.00 0.00 0.00 Plus: Impairment of equity investments 0.00 0.00 0.01 0.00 Plus: Discrete tax items (0.01 ) (0.00 ) (0.01 ) 0.00 Plus: Income tax effect of non-GAAP adjustments 1 (0.01 ) (0.01 ) (0.02 ) (0.02 ) Adjusted earnings (loss) per share – basic $ 0.18 $ 0.02 $ 0.28 $ (0.09 ) Reconciliation of GAAP to adjusted EPS – diluted GAAP earnings (loss) per share – diluted $ 0.06 $ (0.09 ) $ 0.07 $ (0.27 ) Plus: Share-based compensation expenses 0.10 0.09 0.17 0.16 Plus: Depreciation 0.02 0.02 0.04 0.04 Plus: Amortization of intangibles 0.00 0.00 0.00 0.00 Plus: Other 0.00 0.00 0.00 0.00 Plus: Impairment of equity investments 0.00 0.00 0.01 0.00 Plus: Discrete tax items (0.01 ) 0.00 (0.01 ) 0.00 Plus: Income tax effect of non-GAAP adjustments 1 (0.01 ) (0.01 ) (0.02 ) (0.02 ) Adjusted earnings (loss) per share – diluted $ 0.17 $ 0.02 $ 0.27 $ (0.09 ) Reconciliation of GAAP to adjusted earnings (loss) per ADS – basic GAAP earnings (loss) per ADS – basic $ 0.87 $ (1.15 ) $ 0.89 $ (3.56 ) Plus: Share-based compensation expenses 1.39 1.25 2.29 2.10 Plus: Depreciation 0.28 0.23 0.57 0.46 Plus: Amortization of intangibles 0.05 0.01 0.06 0.02 Plus: Other 0.01 0.00 0.01 0.00 Plus: Impairment of equity investments 0.03 0.00 0.14 0.00 Plus: Discrete tax items (0.13 ) 0.01 (0.08 ) 0.02 Plus: Income tax effect of non-GAAP adjustments 1 (0.16 ) (0.13 ) (0.27 ) (0.22 ) Adjusted earnings (loss) per ADS – basic $ 2.33 $ 0.22 $ 3.61 $ (1.17 ) Reconciliation of GAAP to adjusted earnings (loss) per ADS – diluted GAAP earnings (loss) per ADS – diluted 2 $ 0.84 $ (1.13 ) $ 0.85 $ (3.56 ) Plus: Share-based compensation expenses 1.34 1.23 2.20 2.10 Plus: Depreciation 0.27 0.22 0.55 0.46 Plus: Amortization of intangibles 0.05 0.01 0.06 0.02 Plus: Other 0.01 0.00 0.01 0.00 Plus: Impairment of equity investments 0.03 0.00 0.14 0.00 Plus: Discrete tax items (0.13 ) 0.01 (0.08 ) 0.02 Plus: Income tax effect of non-GAAP adjustments 1 (0.16 ) (0.13 ) (0.26 ) (0.22 ) Adjusted earnings (loss) per ADS – diluted $ 2.25 $ 0.22 $ 3.48 $ (1.17 ) Article content 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. 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. Article content Article content Article content Article content Article content Contacts Article content Investor Contact Article content Article content Liza Heapes Article content Article content +1 857-302-5663 Article content Article content ir@ Article content Media Contact Article content Article content Kyle Blankenship Article content Article content Article content
Business Upturn
14-07-2025
- Business
- Business Upturn
Waldenstrom Macroglobulinemia Market Sees Surging Demand Across the 7MM Amid BTK Inhibitor Advancements
New York, USA, July 14, 2025 (GLOBE NEWSWIRE) — Waldenstrom Macroglobulinemia Market Sees Surging Demand Across the 7MM Amid BTK Inhibitor Advancements | DelveInsight The Waldenstrom macroglobulinemia market is witnessing steady growth driven by advances in targeted therapies, particularly BTK inhibitors like IMBRUVICA and BRUKINSA. Rising awareness, improved diagnostic techniques, and increasing clinical trial activity are further propelling market expansion. DelveInsight's Waldenstrom Macroglobulinemia Market Insights report includes a comprehensive understanding of current treatment practices, emerging Waldenstrom macroglobulinemia drugs, market share of individual therapies, and current and forecasted Waldenstrom macroglobulinemia market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Waldenstrom Macroglobulinemia Market Report According to DelveInsight's analysis, the total Waldenstrom macroglobulinemia market size is expected to grow positively by 2034. The United States accounts for the largest market size of Waldenstrom macroglobulinemia, in comparison to EU4 (Germany, Italy, France, and Spain) and the UK, and Japan. Waldenström macroglobulinemia affects about 1 in 3.4 million American males and about half that number of American females. The incidence of waldenström macroglobulinemia is estimated to be about 5 per 1,000,000 people over the age of 50. American males and about half that number of American females. The incidence of waldenström macroglobulinemia is estimated to be about people over the age of 50. Prominent companies, including Cellectar Biosciences, Merck Sharp & Dohme, BeiGene, Nurix Therapeutics, Ascentage Pharma, TransThera Biosciences, and others, are actively working on innovative Waldenstrom macroglobulinemia drugs. and others, are actively working on innovative Waldenstrom macroglobulinemia drugs. Some of the key Waldenstrom macroglobulinemia therapies in the pipeline include Iopofosine, Nemtabrutinib, Sonrotoclax, NX-5948, Lisaftoclax, TT-01488 , and others. These novel Waldenstrom macroglobulinemia therapies are anticipated to enter the Waldenstrom macroglobulinemia market in the forecast period and are expected to change the market. , and others. These novel Waldenstrom macroglobulinemia therapies are anticipated to enter the Waldenstrom macroglobulinemia market in the forecast period and are expected to change the market. In June 2025, Cellectar Biosciences announced that the US FDA granted Breakthrough Therapy Designation (BTD) for iopofosine I 131 in Waldenstrom macroglobulinemia. announced that the US FDA granted Breakthrough Therapy Designation (BTD) for iopofosine I 131 in Waldenstrom macroglobulinemia. In June 2025, BeiGene showcased encouraging Phase I/II (CaDAnCe-101) results for BGB-16673 in waldenström macroglobulinemia at EHA 2025. showcased encouraging Phase I/II (CaDAnCe-101) results for BGB-16673 in waldenström macroglobulinemia at EHA 2025. In March 2025, the US FDA granted orphan drug designation to bexobrutideg (NX-5948) for the treatment of Waldenstrom macroglobulinemia. Discover which Waldenstrom macroglobulinemia medications are expected to grab the market share @ Waldenstrom Macroglobulinemia Market Report Waldenstrom Macroglobulinemia Overview Waldenstrom macroglobulinemia is a rare, slow-growing type of non-Hodgkin lymphoma characterized by the excessive production of abnormal white blood cells that secrete large amounts of a monoclonal IgM protein. These abnormal cells accumulate in the bone marrow and can interfere with the normal production of blood cells. The exact cause of Waldenstrom macroglobulinemia is not fully understood, but it is believed to arise due to genetic mutations, most commonly in the MYD88 gene, and possibly immune system dysregulation. Risk factors may include age, male gender, family history, and certain inherited conditions. Symptoms of Waldenstrom macroglobulinemia can vary significantly and often develop gradually. Common clinical signs include fatigue, weight loss, night sweats, and swollen lymph nodes. The excess IgM protein can cause hyperviscosity syndrome, leading to headaches, vision problems, dizziness, and bleeding issues. Some patients may also experience neuropathy, cold sensitivity, or enlargement of the spleen and liver. Diagnosis typically involves a combination of blood tests, bone marrow biopsy, and molecular testing to identify MYD88 or CXCR4 mutations. Imaging may also be used to assess organ involvement. Early and accurate diagnosis is key to managing this indolent but complex hematologic malignancy. Waldenstrom Macroglobulinemia Epidemiology Segmentation The Waldenstrom macroglobulinemia epidemiology section provides insights into the historical and current Waldenstrom macroglobulinemia patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Waldenstrom macroglobulinemia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Waldenstrom Macroglobulinemia Gender-specific Cases of Waldenstrom Macroglobulinemia Age-specific Cases of Waldenstrom Macroglobulinemia Gene Mutations in Waldenstrom Macroglobulinemia Download the report to understand which factors are driving Waldenstrom macroglobulinemia epidemiology trends @ Waldenstrom Macroglobulinemia Treatment Algorithm Waldenstrom Macroglobulinemia Treatment Market Significant progress has been made in the treatment of Waldenström macroglobulinemia, a rare form of cancer, with therapies increasingly tailored to its unique clinical challenges. The Waldenström macroglobulinemia treatment landscape is primarily led by BTK inhibitors such as IMBRUVICA and BRUKINSA, alongside rituximab-based regimens and BCL-2 inhibitors like VENETOCLAX, which serve as complementary options. These targeted therapies have revolutionized clinical outcomes by extending progression-free survival and enhancing response rates, while maintaining manageable side effects. BRUKINSA (zanubrutinib) from BeiGene represents a next-generation BTK inhibitor, engineered for improved selectivity and reduced off-target activity compared to earlier BTK inhibitors. It received U.S. FDA approval in 2021 for treating adults with Waldenström macroglobulinemia and has also been authorized by the EMA and other global regulatory bodies for use in this and other B-cell malignancies. IMBRUVICA (ibrutinib), developed by Janssen and AbbVie, was the first BTK inhibitor to gain FDA approval in 2015 for adult patients with Waldenström macroglobulinemia. As a pioneering agent in its class, it transformed the treatment approach by disrupting B-cell signaling pathways that drive malignant cell growth. That same year, the European Commission also approved its use. Rituximab remains the most commonly used monoclonal antibody for treating Waldenström macroglobulinemia. It works by binding to the CD20 protein found on the surface of lymphoma cells, triggering their destruction. Administered via intravenous infusion in clinical settings, rituximab may be used as a standalone therapy or in combination with chemotherapy, targeted treatments, or other agents. Learn more about the Waldenstrom macroglobulinemia treatment options @ Waldenstrom Macroglobulinemia Treatment Guidelines Waldenstrom Macroglobulinemia Emerging Drugs and Companies The potential drugs in the pipeline include Iopofosine (Cellectar Biosciences), Nemtabrutinib (Merck Sharp & Dohme), Sonrotoclax (BeiGene), NX-5948 (Nurix Therapeutics), Lisaftoclax (Ascentage Pharma), TT-01488 (TransThera Biosciences), and others. Iopofosine is a small-molecule Phospholipid Drug Conjugate (PDC) engineered to deliver iodine-131 directly to cancer cells in a targeted manner. It was recently assessed in the pivotal Phase II CLOVER-WaM study involving patients with relapsed/refractory Waldenstrom macroglobulinemia (R/R WM). The U.S. FDA has granted Fast Track Designation to iopofosine for use in patients with lymphoplasmacytic lymphoma (LPL) and Waldenstrom macroglobulinemia who have undergone at least two prior therapies. Furthermore, the drug has received Orphan Drug Designation (ODD) for LPL/WM. In the European Union, the European Commission has granted ODD for relapsed/refractory multiple myeloma and WM, along with PRIME designation specifically for WM, acknowledging its potential to address significant unmet clinical needs. In June 2025, the FDA also awarded Breakthrough Therapy Designation (BTD) to iopofosine I-131 for treating R/R WM. Nemtabrutinib is an experimental, reversible, non-covalent BTK inhibitor under investigation for its ability to block oncogenic B-cell receptor signaling. It is active against both wild-type BTK and BTK pathway mutations. Ongoing Phase II trials are evaluating its effectiveness in hematologic cancers, including chronic lymphocytic leukemia (CLL) and Waldenstrom macroglobulinemia. Unlike conventional BTK inhibitors, nemtabrutinib retains activity even against BTK proteins that have developed mutations. Sonrotoclax is a BH3 mimetic designed to inhibit BCL2, a protein that enables cancer cell survival. By mimicking natural signals that promote cell death, sonrotoclax induces apoptosis in B-cell malignancies. Preclinical and early clinical studies have demonstrated that it is a potent and selective BCL2 inhibitor, characterized by a short half-life and no accumulation in the body. It has shown encouraging clinical results across multiple B-cell cancers, with over 1,300 patients treated globally. The U.S. FDA has granted Fast Track Designation to sonrotoclax for treating Waldenstrom macroglobulinemia. The anticipated launch of these emerging Waldenstrom macroglobulinemia therapies are poised to transform the Waldenstrom macroglobulinemia market landscape in the coming years. As these cutting-edge Waldenstrom macroglobulinemia therapies continue to mature and gain regulatory approval, they are expected to reshape the Waldenstrom macroglobulinemia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about new treatment for Waldenstrom macroglobulinemia, visit @ Waldenstrom Macroglobulinemia Management Waldenstrom Macroglobulinemia Market Dynamics The Waldenstrom macroglobulinemia market dynamics are anticipated to change in the coming years. The availability of targeted therapies such as BTK inhibitors (IMBRUVICA, BRUKINSA) and monoclonal antibodies (rituximab), along with the identification of MYD88 L265P and CXCR4 mutations, enables more personalized and effective treatment approaches, while emerging options like novel BTK inhibitors, CAR-T therapies, bispecific antibodies, and the development of new drug classes and combination regimens hold promise for significantly enhancing treatment outcomes. Furthermore, many potential therapies are being investigated for the treatment of Waldenstrom macroglobulinemia, and it is safe to predict that the treatment space will significantly impact the Waldenstrom macroglobulinemia market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the Waldenstrom macroglobulinemia market in the 7MM. However, several factors may impede the growth of the Waldenstrom macroglobulinemia market. Targeted therapies like BTK inhibitors are often expensive, creating accessibility and reimbursement challenges, especially in lower-income countries, while resistance or intolerance to existing treatments like IMBRUVICA and BRUKINSA further necessitate alternative options, yet stringent approval processes and high clinical trial costs can significantly delay the launch of these new therapies. Moreover, Waldenstrom macroglobulinemia treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Waldenstrom macroglobulinemia market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Waldenstrom macroglobulinemia market growth. Waldenstrom Macroglobulinemia Report Metrics Details Study Period 2020–2034 Waldenstrom Macroglobulinemia Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Waldenstrom Macroglobulinemia Companies Cellectar Biosciences, Merck Sharp & Dohme, BeiGene, Nurix Therapeutics, Ascentage Pharma, TransThera Biosciences, BioGene, Janssen, AbbVie, and others Key Waldenstrom Macroglobulinemia Therapies Iopofosine, Nemtabrutinib, Sonrotoclax, NX-5948, Lisaftoclax, TT-01488, BRUKINSA, IMBRUVICA, and others Scope of the Waldenstrom Macroglobulinemia Market Report Waldenstrom Macroglobulinemia Therapeutic Assessment: Waldenstrom Macroglobulinemia current marketed and emerging therapies Waldenstrom Macroglobulinemia current marketed and emerging therapies Waldenstrom Macroglobulinemia Market Dynamics: Conjoint Analysis of Emerging Waldenstrom Macroglobulinemia Drugs Conjoint Analysis of Emerging Waldenstrom Macroglobulinemia Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Waldenstrom Macroglobulinemia Market Access and Reimbursement Discover more about Waldenstrom macroglobulinemia drugs in development @ Waldenstrom Macroglobulinemia Clinical Trials Table of Contents 1. Waldenstrom Macroglobulinemia Market Key Insights 2. Waldenstrom Macroglobulinemia Market Report Introduction 3. Waldenstrom Macroglobulinemia Market Overview at a Glance 4. Waldenstrom Macroglobulinemia Market Executive Summary 5. Disease Background and Overview 6. Waldenstrom Macroglobulinemia Treatment and Management 7. Waldenstrom Macroglobulinemia Epidemiology and Patient Population 8. Patient Journey 9. Waldenstrom Macroglobulinemia Marketed Drugs 10. Waldenstrom Macroglobulinemia Emerging Drugs 11. Seven Major Waldenstrom Macroglobulinemia Market Analysis 12. Waldenstrom Macroglobulinemia Market Outlook 13. Potential of Current and Emerging Therapies 14. KOL Views 15. Unmet Needs 16. SWOT Analysis Related Reports Waldenstrom Macroglobulinemia Pipeline Waldenstrom Macroglobulinemia Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Waldenstrom macroglobulinemia companies, including BeiGene, Cellectar Biosciences, Inc., Nurix Therapeutics, Inc., VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), Schrodinger, Inc., Loxo Oncology, Inc., Nkarta, Inc., Merck Sharp & Dohme LLC, ADC Therapeutics S.A., Bio-Path Holdings, Inc., Millennium Pharmaceuticals, Inc., Carna Biosciences, Inc., among others. Non-Hodgkin's Lymphoma Market Non-Hodgkin's Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NHL companies, including AbbVie, Genmab, Novartis, Angiocrine Bioscience, Autolus, Zentera Therapeutics, Jiangsu Hengrui Medicine, among others. Non-Hodgkin's Lymphoma Pipeline Non-Hodgkin's Lymphoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key NHL companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc., among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Sanofi, Karyopharm Therapeutics, AbbVie, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key DLBCL companies, including Roche (Genentech), Biogen, Nektar Therapeutics, Merck, Allogene Therapeutics, Miltenyi Biomedicine, AstraZeneca, BioVaxys, ImmunoVaccine Technologies, Cellectar Biosciences, Galapagos, Novartis, Lyell, ImmPACT Bio, Pfizer, Kartos Therapeutics, 2seventy bio, Regeneron Pharmaceuticals, BeiGene, Ranok Therapeutics, Constellation Pharmaceuticals, Genmab, IDP Discovery Pharma S.L., Immunitas Therapeutics, Monte Rosa Therapeutics, SymBio Pharmaceuticals, AVM Biotechnology, Autolus Therapeutics, Kymera Therapeutics, Otsuka Pharmaceutical, Caribou Biosciences, Adicet Bio, Gilead Sciences, Xynomic Pharmaceuticals, Amgen, among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Connect with us on LinkedIn|Facebook|Twitter Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Business Wire
25-06-2025
- Business
- Business Wire
BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA ®
BASEL, Switzerland--(BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of a new film-coated tablet formulation of BRUKINSA ® (zanubrutinib) for all approved indications. The CHMP positive opinion will now be reviewed by the European Commission, which will grant the marketing authorization for the tablet formulation in the European Union and in the European Economic Area countries Norway and Iceland. 'The CHMP's positive opinion of our new tablet formulation of BRUKINSA is an important step toward bringing this thoughtful, patient-centered innovation to people facing certain B-cell cancers across Europe,' said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. 'We look forward to a potential approval later this year and remain committed to delivering our impactful medicines to more patients in the region.' The BRUKINSA tablets have been shown to be bioequivalent to the BRUKINSA capsules based on the results of two single-dose, open-label, randomized Phase 1 crossover studies in healthy subjects. The recommended dose of BRUKINSA remains – 320 mg daily. The BRUKINSA tablets are 160 mg each, allowing patients to halve their daily pill intake and take two tablets daily. The new tablet formulation maintains BRUKINSA's dosing flexibility by providing patients and prescribers with the option of once- or twice-daily dosing and is designed to simplify management of dose reductions as per label recommendation. Additionally, the BRUKINSA tablets are smaller than the capsules and have a film coat, which makes them easier to swallow. BeOne Medicines will begin to convert BRUKINSA from capsules to tablets in regions outside China in 2025 as part of our commitment to sustainable business practices, including reducing our impact on the environment. This adjustment will decrease the bottle size by ~70% while also enabling the shipment of this medication with reduced temperature controls, which we expect to reduce energy needs, greenhouse gas emissions, and global transport costs. Today's announcement follows the U.S. Food and Drug Administration (FDA) approval of the new tablet formulation of BRUKINSA for all five approved indications earlier this month. In the U.S., BRUKINSA is the leader in new patient starts for chronic lymphocytic leukemia (CLL) across all lines of therapy, and for the first time, has become the overall BTK inhibitor market share leader. 1 Important Safety Information The current European Summary of Product Characteristics (SmPC) of BRUKINSA is available from the website of the European Medicines Agency. This information is intended for a global audience. Product indications vary by region. About BeOne Medicines 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 LinkedIn, X, Facebook and Instagram. Forward-Looking Statement 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 the future potential approval of the tablet formulation of BRUKINSA by the European Commission and the timing of such approval; and BeOne's plans, commitments, aspirations, and goals under the heading '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 and its ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's 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. To access BeOne media resources, please visit our Newsroom.
Business Wire
12-06-2025
- Business
- Business Wire
BeOne Medicines Showcases Breakthrough Data in CLL and MCL at EHA 2025
SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will present new clinical data from three cornerstone hematology assets at the European Hematology Association (EHA) Congress. Four oral presentations highlight the promising clinical activity of BeOne's next-generation BCL2 inhibitor sonrotoclax, BTK protein degrader BGB-16673, and the backbone of our hematology franchise, BTK inhibitor BRUKINSA (zanubrutinib), which has the broadest label globally of any approved BTK inhibitor. These data reinforce the company's strategic vision to redefine the standard of care for B-cell malignancies. 'The data presented at EHA 2025 underscore the strength of BeOne's comprehensive hematology pipeline, built on the success of BRUKINSA, the only BTK inhibitor to demonstrate superior progression-free survival over ibrutinib in a Phase 3 trial, 1 ' said Lai Wang, Ph.D. Global Head of R&D at BeOne. 'With our potentially best-in-class BCL2 inhibitor, sonrotoclax, and first-in-class BTK degrader, BGB-16673, we are advancing innovative therapies aimed at addressing resistance mechanisms and improving outcomes for patients with B-cell malignancies.' The data presented at EHA 2025 support the ongoing advancement of sonrotoclax and BGB-16673 into Phase 3 studies and lay the groundwork for BeOne's first regulatory submissions for these programs. The company's integrated development approach—anchored in differentiated mechanisms and translational science—positions its programs to address key areas of unmet need in hematologic oncology. 'While existing therapies have improved outcomes in CLL and related malignancies, many patients still relapse or develop resistance and continue to face limited options,' said Stephan Stilgenbauer, Professor of Medicine and Medical Director of the Comprehensive Cancer Center Ulm (CCCU), Head of the Early Clinical Trials Unit (ECTU), and Head of the Division of CLL Dept. of Internal Medicine III at Ulm University. 'The updated data presented at EHA underscore the potential of novel approaches, including BTK degradation and BCL2-based combinations, to overcome known mechanisms of resistance and expand treatment options for patients.' Sonrotoclax + BRUKINSA Demonstrates Deep Responses in CLL and MCL BeOne's data will highlight the emerging potential of its next-generation assets to address the unmet needs of patients with B-cell malignancies. Updated results from Phase 1 studies evaluating sonrotoclax in combination with BRUKINSA in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and with R/R mantle cell lymphoma (MCL) demonstrated consistent, deep responses and a manageable safety profile. Sonrotoclax is well-positioned to improve key aspects of the BCL2 inhibitor class and has demonstrated robust and durable antitumor activity and a tolerable safety profile across all dose levels. Robust Early Results in CLL and WM with Potentially First-in-Class BTK Degrader As the most clinically advanced BTK degrader, BGB-16673 continues to show potential in patients with various hematological malignancies. Updated data from the ongoing Phase 1 CaDAnCe-101 study of BGB-16673 in R/R CLL/SLL and R/R Waldenström macroglobulinemia (WM) showed substantial antitumor activity and a tolerable safety profile across heavily pretreated populations. BRUKINSA Monotherapy Showed Sustained OS and PFS Benefit Data from Arm D of the SEQUOIA Phase 3 trial will also be presented at the meeting (Abstract PS1566), demonstrating that treatment with BRUKINSA plus venetoclax has the potential to drive progression-free survival and overall deep and durable responses across the frontline CLL patient spectrum, including patients with high-risk mutational status. SEQUOIA Arm D investigated BRUKINSA plus venetoclax in 114 patients with treatment-naïve (TN) CLL / SLL with or without del(17p) and/or TP53 high-risk mutations. At a median follow-up of 31.2 months, the combination induced a high 24-month progression-free survival (PFS) rate of 92% (95% CI, 85-96%) and an impressive overall response rate (ORR) of 97%. The 24-month overall survival (OS) rate was 96% (95% CI, 90%-98%). Notably, these benefits were observed regardless of del(17p)/ TP53 mutational status. The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. Arm C of the SEQUOIA study investigated BRUKINSA monotherapy in patients with TN CLL / SLL and del(17p) mutations, representing the largest prospective cohort of CLL/SLL patients with del(17p), will be presented at EHA (Abstract: PS1565). At a median follow-up of over 5.5 years (65.8 months), most patients remained progression-free. Notably, at 60 months, 72.2% of patients who received BRUKINSA remained progression-free (95% CI, 62.4, 79.8). When adjusted for the impact of the COVID-19 pandemic, 73.0% of patients in the cohort remained progression-free (95% CI, 63.3, 80.6) at 60 months. The 60-month OS rate was 85.1% (95% CI, 76.9, 90.6) and 87.0% (95% CI, 79.0, 92.1) when adjusted for COVID-19. At the time of data cut-off, the ORR was 97.3%, and 62.2% of patients were still receiving treatment with BRUKINSA. The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. BeOne will host an investor R&D Day on June 26 at 8:30 am ET covering our deep and broad global innovation pipeline and platforms, as well as the Company's vision, differentiated capabilities, and value creation drivers. The live webcast can be accessed from the investors section of BeOne's website at or An archived replay will be available to investors for 90 days following the event. About Sonrotoclax (BGB-11417) Sonrotoclax is designed to block the B-cell lymphoma 2 (BCL2) protein, which is one of several proteins that help cancer cells survive. It is part of a group of drugs called BH3 mimetics, which mimic natural cell death signals. Studies in the lab and during early drug development have shown that sonrotoclax is a potent and specific inhibitor of BCL2 with a short half-life and no accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, and more than 1,900 patients have been enrolled to date across the global development program. The U.S. Food and Drug Administration (FDA) granted sonrotoclax Fast Track Designation for the treatment of adult patients with mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM). About BGB-16673 BGB-16673 is an orally available Bruton's tyrosine kinase (BTK) targeting protein degrader from BeOne's chimeric degradation activation compound (CDAC) platform. BGB-16673 is designed to promote the degradation, or breakdown, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease. BGB-16673 is the most advanced BTK protein degrader in the clinic, with an extensive global clinical development program. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BGB-16673 for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL). About BRUKINSA ® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton's tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is also the only BTK inhibitor to demonstrate PFS superiority to a first-generation BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved for at least one indication in more than 75 markets, and more than 200,000 patients have been treated globally. Select Important Safety Information Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury). In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Please see full U.S. Prescribing Information including U.S. Patient Information. The information provided in this press release is intended for a global audience. Product indications vary by region. 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 LinkedIn, X, Facebook and Instagram. Forward-Looking Statement 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 the strength of BeOne's hematology pipeline; BeOne's ability to advance innovative therapies and improve outcomes for patients with B-cell malignancies; the ability of BeOne's assets to address unmet needs of patients with B-cell malignancies and areas of hematologic oncology; the ability of sonrotoclax to improve the BCL2 inhibitor class and the asset's future capabilities; the future potential of BGB-16673 in patients with hematological malignancies; the ability for BTK degradation and BCL2-based combinations to expand treatment options for patients; and BeOne's plans, commitments, aspirations, and goals under the heading '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 and its ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's 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. 1 Brown, Jennifer R et al. 'Sustained benefit of zanubrutinib vs ibrutinib in patients with R/R CLL/SLL: final comparative analysis of ALPINE.' Blood
