May 6, 2026 — Leads & Copy — BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) has released its financial results and corporate updates for the first quarter of 2026, showcasing significant growth and progress in its oncology programs.
According to John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, the company’s strong first-quarter results underscore its position as a global oncology leader, fueled by disciplined commercial execution and a robust pipeline in hematology and solid tumors. He emphasized the competitive advantages of BeOne’s global clinical development and manufacturing capabilities.
BRUKINSA, BeOne’s BTK inhibitor, has become a foundational treatment for CLL, demonstrating long-term efficacy and safety data. It is the only BTKi with proven efficacy superiority over ibrutinib, leading to global revenue leadership. The combination of sonrotoclax and BRUKINSA is emerging as a potential standard-of-care in first-line CLL, with BTK CDAC BGB-16673 showing promise as a first-in-class therapy in relapsed or refractory settings. BeOne will present over 20 abstracts across its hematology and solid tumor pipeline at ASCO.
Key financial highlights from the first quarter of 2026 include:
- Total revenue increased by 35% to $1.51 billion, compared to $1.12 billion in the prior-year period.
- Net product revenues grew by 34% to $1.49 billion.
- GAAP income from operations surged by 2,151% to $249.9 million.
- Adjusted income from operations increased by 197% to $414.4 million.
- GAAP net income reached $227.4 million, a substantial increase from $1.3 million in the prior-year period.
- Adjusted net income rose by 175% to $375 million.
- GAAP basic EPS per ADS was $2.05, compared to $0.01 in the prior-year period.
- Adjusted basic EPS per ADS was $3.38, compared to $1.27 in the prior-year period.
- Free Cash Flow was $160.5 million, a significant increase from $(12.3) million in the prior-year period.
Product-specific revenue highlights include:
- BRUKINSA: Global sales totaled $1.1 billion, a 38% increase year-over-year, with U.S. sales reaching $761 million, a 35% increase.
- TEVIMBRA (tislelizumab): Global sales totaled $206 million, a 20% increase year-over-year.
- Amgen in-licensed products: Global sales totaled $142 million, a 25% increase year-over-year.
The gross margin for the first quarter of 2026 was 89%, compared to 85% in the prior-year period, driven by a higher sales mix of BRUKINSA and productivity improvements for BRUKINSA and TEVIMBRA.
Operating expenses for the first quarter of 2026 were:
- Research and Development (R&D): GAAP expenses increased by 12% to $541.2 million; Non-GAAP expenses increased by 11% to $465.9 million.
- Selling, General, and Administrative (SG&A): GAAP expenses increased by 21% to $555.1 million; Non-GAAP expenses increased by 19% to $472 million.
BeOne has updated its full-year 2026 financial guidance, with total revenue now projected to be between $6.3 billion and $6.5 billion, up from the previous guidance of $6.2 billion to $6.4 billion. GAAP operating income is expected to be between $750 million and $850 million, and non-GAAP operating income is projected to be between $1.45 billion and $1.55 billion.
Business highlights for the first quarter of 2026 include:
- BRUKINSA: Received Orphan Drug Designation in Japan for relapsed or refractory marginal zone lymphoma (MZL) and submitted a New Drug Application in Japan for R/R MZL and a tablet formulation.
- Sonrotoclax: Launched in China for R/R mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and included in ESMO guidelines as a third-line treatment for R/R MCL.
- TEVIMBRA: Received acceptance of a sBLA by the FDA with Priority Review and by the CDE in China for first-line HER2-positive gastroesophageal adenocarcinoma (GEA) in combination with ZIIHERA (zanidatamab) and chemotherapy.
- ZIIHERA: Received acceptance of sBLA by the CDE in China for first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA.
Select Clinical-Stage Programs highlights:
- BGB-16673 (BTK CDAC): Initiated Phase 2 cohorts in R/R MZL and Richter’s Transformation.
- BGB-43395 (CDK4 inhibitor) and BG-C9074 (B7-H4 ADC): Received acceptance of Phase 1 study data as poster/oral presentations at ASCO.
- BGB-B2033 (GPC3x41BB bispecific antibody): Received FDA Orphan Drug Designation for hepatocellular carcinoma (HCC) and initiated a potentially registrational study in patients with HCC.
- BG-C0979 (ADAM9-targeting ADC) and BG-A3004 (KLRG1 mAb): Initiated first-in-human studies.
Anticipated R&D Milestones include interim analysis of the Phase 3 MANGROVE study for BRUKINSA in first-line MCL (1H 2026), regulatory action in Japan for BRUKINSA in first-line gastric cancer (1H 2026), and FDA regulatory action for TEVIMBRA in first-line HER2-positive GEA (2H 2026).
Corporate Updates: BeOne entered into an exclusive option with Huahui Health to license worldwide rights to HH160 (BON-110), a novel trispecific antibody targeting PD-1, VEGF-A and CTLA-4.
The company’s earnings conference call will be broadcast via webcast at 8:00 a.m. ET on Wednesday, May 6, 2026, accessible through the Investors section of BeOne’s website.
BeOne Medicines is dedicated to discovering and developing innovative treatments for cancer patients worldwide, with a diverse pipeline of novel therapeutics.
Source: www.businesswire.com
