On August 6, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the second quarter of 2025 (Press release, BeOne Medicines, AUG 6, 2025, View Source [SID1234654860]).
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"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 %
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 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’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.
2H 2025
•Interim analysis of Phase 3 MANGROVE trial for the treatment of treatment-naïve MCL.
2H 2025
TEVIMBRA
•EU approval for the treatment of neoadjuvant and adjuvant early stage NSCLC.
2H 2025
•Initiate Phase 3 trial for subcutaneous formulation.
2H 2025
Hematology
•Sonrotoclax: Data readout of Phase 2 trial and potential global accelerated approval submissions for the treatment of R/R MCL.
2H 2025
•BGB-16673: Initiate Phase 3 head-to-head trial compared to noncovalent BTK inhibitor pirtobrutinib for the treatment of R/R CLL.
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.
2026
◦Initiate Phase 3 trial for the treatment of first-line hormone receptor-positive, HER2-negative metastatic breast cancer.
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.
2H 2025
◦Proof-of-concept data for tissue IRAK4 degradation.
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 www.beonemedicines.com. Supplemental information in the form of a slide presentation and a replay of the webcast will also be available.