BeOne Medicines NASDAQ: ONC reported second-quarter revenue of $1.7 billion, up 30% from a year earlier, and GAAP earnings per ADS of $2.05, up 144%, as sales of its BTK inhibitor BRUKINSA continued to expand across approved indications and global markets.
Chief Executive Officer John Oyler said the company raised its 2026 guidance for revenue and GAAP operating income, citing stronger-than-expected commercial performance and continued progress across its hematology and solid-tumor pipeline.
BRUKINSA Drives Commercial Growth
BRUKINSA generated more than $1.2 billion in global revenue during the quarter, an increase of 31% year over year. U.S. BRUKINSA sales totaled $893 million, also up 31%. Oyler said the drug recorded its highest sustained level of new patient starts since launch, more than six years after its initial introduction.
Chief Financial Officer Aaron Rosenberg said growth was supported by demand in chronic lymphocytic leukemia, or CLL, as well as the drug’s non-CLL indications. BRUKINSA is approved in five B-cell malignancies, including mantle cell lymphoma, Waldenstrom’s macroglobulinemia, marginal zone lymphoma and follicular lymphoma.
Rosenberg said non-CLL indications represent about one-third of the total prevalence across BRUKINSA’s five approved uses and that the company has strong share in those settings. He also cited potentially favorable treatment duration, real-world evidence on treatment discontinuation and improved patient adherence following the launch of a tablet formulation late last year.
The company said it was not yet seeing a meaningful impact in the U.S. from the launch of acalabrutinib plus venetoclax. Oyler said it was still early to determine how the competitive situation could evolve.
BRUKINSA has treated more than 300,000 patients in more than 80 markets, according to the company. Oyler said BeOne believes the medicine’s clinical and real-world evidence supports its position as the leading BTK inhibitor.
Financial Results and Raised Outlook
BeOne reported gross profit of CNY 1.5 billion and a gross margin of just under 90%, benefiting from product mix and productivity improvements for BRUKINSA and TEVIMBRA. Operating expenses were CNY 1.2 billion, up 13%, reflecting clinical-development and commercial investments.
GAAP income from operations was CNY 325 million, while net income was CNY 237 million. Net income included an approximately CNY 60 million impact from a previously disclosed tax audit settlement. Adjusted income from operations rose more than 80% year over year to CNY 503 million, while adjusted diluted earnings per ADS increased to $3.84 from $2.25.
Free cash flow doubled from the prior-year period to CNY 435 million, Rosenberg said.
The company increased its full-year revenue outlook by CNY 300 million to a range of CNY 6.6 billion to CNY 6.8 billion. It now expects GAAP operating income of CNY 1 billion to CNY 1.1 billion and non-GAAP operating income of CNY 1.7 billion to CNY 1.8 billion, representing a CNY 250 million increase in operating-income guidance across the range.
BeOne expects gross margin to remain in the high-80% range and operating expenses to total CNY 4.8 billion to CNY 5 billion for the year. Rosenberg said expenses could continue growing year over year in 2027 at a rate similar to the past two years as key pipeline assets progress.
Hematology Pipeline Milestones
During the quarter, the FDA approved Beqalzi for relapsed or refractory mantle cell lymphoma, making it the first approved BCL-2 inhibitor in that disease, according to the company.
BeOne also highlighted positive results from its Phase III MANGROVE trial evaluating BRUKINSA plus rituximab in previously untreated mantle cell lymphoma. Chief Medical Officer of Hematology Amit Agarwal said the chemotherapy-free regimen was superior to bendamustine plus rituximab, with a hazard ratio of 0.57 favoring the BRUKINSA-based regimen.
The company plans global regulatory submissions for the MANGROVE regimen in the second half of 2026 and expects to present full data at an upcoming medical meeting. Agarwal said physician and key opinion leader feedback on the findings has been positive, particularly because the regimen could reduce exposure to chemotherapy and rituximab infusions.
BeOne’s CELESTIMO-301 study of zanubrutinib plus sonrotoclax did not achieve statistical superiority over venetoclax plus obinutuzumab in an undetectable minimal residual disease analysis. However, President and Global Head of Research and Development Lai Wang said the independent data monitoring committee recommended continuing the trial toward its primary progression-free survival endpoint.
The company also said its BTK degrader tacabrutideg remains on track for a potential accelerated-approval submission in relapsed or refractory CLL by the end of 2026, if data support filing. A Phase III trial comparing tacabrutideg with pirtobrutinib is ongoing, and BeOne plans to begin a tacabrutideg-sonrotoclax Phase III combination study in relapsed or refractory CLL in 2027.
Solid-Tumor Programs Advance
TEVIMBRA generated $229 million in global sales, up 18% year over year. The FDA accepted and granted priority review to BeOne’s application for TEVIMBRA in combination with ZIIHERA and chemotherapy for first-line HER2-positive gastroesophageal adenocarcinoma. China’s drug regulator also accepted submissions involving TEVIMBRA and ZIIHERA.
In development, BeOne said its CDK4 inhibitor BGB-43395 has entered Phase III development in breast cancer. At the Phase III dose, the drug combined with letrozole produced an objective response rate of about 70% in first-line HR-positive, HER2-negative metastatic breast cancer, according to Wang. At 400 milligrams, overall neutropenia was 21%, with no grade 3 or higher events reported.
The company expects to begin pivotal trials by year-end for its GPC3 4-1BB bispecific antibody in second-line hepatocellular carcinoma and its B7-H4 antibody-drug conjugate in first-line maintenance ovarian cancer. BeOne also plans to present initial proof-of-concept data at ESMO for its PRMT5 inhibitor and CEA-targeting antibody-drug conjugate.
Oyler also said BeOne plans a $300 million expansion of its U.S. manufacturing site in Hopewell, New Jersey.
About BeOne Medicines (NASDAQ:ONC)
BeOne Medicines Ltd. 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. The firm portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The company was founded by Xiao Dong Wang and John V. Oyler on October 28, 2010 and is headquartered in Basel, Switzerland.
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