Key Takeaways:
BeOne Medicines reported second-quarter revenue of $1.7 billion, up 30% from a year earlier, as Brukinsa (zanubrutinib) global sales jumped 31% to $1.2 billion.
"These strong second-quarter results underscore our continued growth as a global oncology leader," John V. Oyler, co-founder, chairman and CEO of BeOne, said.
GAAP net income rose to $237 million from $94.3 million, with diluted earnings per ADS of $2.05 versus $0.84. Gross margin widened to 90% from 87%, helped by a higher sales mix of Brukinsa and manufacturing efficiencies for both Brukinsa and Tevimbra (tislelizumab). Free cash flow doubled to $435 million.
BeOne raised its full-year 2026 revenue guidance to $6.6 billion to $6.8 billion, up from $6.3 billion to $6.5 billion, and lifted GAAP operating income guidance to $1 billion to $1.1 billion. CLSA raised its price target on the U.S.-listed shares to $522.5 from $501.3, maintaining an Outperform rating, after the results beat market expectations. The broker estimated Brukinsa's U.S. market share expanded to 43.1% in the second quarter from 42% in the first.
U.S. sales of Brukinsa, a Bruton's tyrosine kinase inhibitor approved in five B-cell malignancies, totaled $893 million, up 31%. Tevimbra generated $229 million globally, up 18%, after receiving regulatory approval in Japan for first-line gastric cancer. The company said Brukinsa has treated more than 300,000 patients across 80-plus markets.
The quarter included several regulatory and clinical milestones. The FDA granted accelerated approval to Beqalzi (sonrotoclax) for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of therapy, including a BTK inhibitor. Positive topline results from the Phase 3 MANGROVE study showed Brukinsa combined with rituximab delivered superior progression-free survival versus bendamustine plus rituximab in previously untreated mantle cell lymphoma, with a hazard ratio of 0.57 favoring the Brukinsa-based regimen. BeOne plans global regulatory submissions for first-line mantle cell lymphoma in the second half of 2026.
Long-term data from the Phase 3 SEQUOIA study, presented at the American Society of Clinical Oncology and European Hematology Association meetings, continued to show a sustained progression-free survival benefit for Brukinsa in treatment-naive chronic lymphocytic leukemia at 78 months of follow-up. Full results from the Phase 3 HERIZON-GEA-01 study, evaluating Ziihera (zanidatamab) plus chemotherapy with and without Tevimbra against trastuzumab plus chemotherapy in HER2-positive gastroesophageal adenocarcinoma, were published in the New England Journal of Medicine.
Earlier-stage programs advanced as well. BeOne started a Phase 3 study of its CDK4 inhibitor BGB-43395 combined with letrozole as a first-line treatment for HR-positive, HER2-negative metastatic breast cancer, and initiated a first-in-human study of BON-110, a PD-1, VEGF-A and CTLA-4 trispecific antibody, in lung cancer. The FDA granted Orphan Drug Designation to BGB-58067 for pancreatic ductal adenocarcinoma.
The guidance raise reflects Brukinsa's leadership position in the U.S. and continued expansion in Europe and other markets outside the U.S. Investors will watch for the FDA decision on Tevimbra for first-line HER2-positive gastric cancer, expected in the second half of 2026, and the planned global MANGROVE submissions, which could expand Brukinsa's label into frontline mantle cell lymphoma.
This article is for informational purposes only and does not constitute investment advice.
