BeOne Medicines — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total global revenue for Q3 2026 was $1.9 billion, a 34% increase year-over-year compared to $1.4 billion in Q3 2025.
• Net product revenues were $1.86 billion (33% YoY growth), while other revenue was $35 million (101% YoY growth).
• GAAP diluted earnings per ADS (ADS) were $3.28 for Q3 2026, up 201% from $1.09 in Q3 2025.
• Non-GAAP diluted earnings per ADS were $4.59 for Q3 2026, up 73% from $2.65 in Q3 2025.
• GAAP net income was $385 million for Q3 2026, a 208% increase from $125 million in Q3 2025.
• Adjusted net income was $539 million for Q3 2026, a 77% increase from $304 million in Q3 2025.
• Free cash flow was $474 million for Q3 2026, a 34% increase from $354 million in Q3 2025.
• Gross margin as a percentage of global product sales was 88% in Q3 2026, up from 86% in Q3 2025.
• Adjusted gross margin (excluding depreciation, amortization, and impairment) was 90% in Q3 2026, up from 86% in Q3 2025.
• GAAP operating expenses were $1.25 billion in Q3 2026 (19% increase YoY), while non-GAAP operating expenses were $1.09 billion (24% increase YoY).
• Research and development expenses were $661 million in Q3 2026 (26% increase YoY).
• Selling, general, and administrative expenses were $593 million in Q3 2026 (12% increase YoY).
• GAAP income from operations was $419 million in Q3 2026, a 157% increase from $163 million in Q3 2025.
• Adjusted income from operations was $612 million in Q3 2026, a 79% increase from $341 million in Q3 2025.
• Cash, cash equivalents, and restricted cash totaled $5.87 billion as of September 30, 2026, compared to $4.61 billion as of December 31, 2025.
• Total debt was $1.07 billion as of September 30, 2026, compared to $1.02 billion as of December 31, 2025.

Guidance and Future Outlook:

• Raised full-year 2026 total revenue guidance to $6.9 billion to $7.0 billion (previously $6.6 billion to $6.8 billion).
• Raised full-year 2026 GAAP operating income guidance to $1.2 billion to $1.3 billion (previously $1.0 billion to $1.1 billion).
• Raised full-year 2026 non-GAAP operating income guidance to $1.9 billion to $2.0 billion (previously $1.7 billion to $1.8 billion).
• Maintained full-year 2026 GAAP gross margin guidance in the high-80% range.
• Maintained full-year 2026 GAAP operating expenses guidance at $4.9 billion to $5.0 billion (previously $4.8 billion to $5.0 billion).
• Expects other income (expense) to be an expense of $25 million to $50 million for the full year 2026.
• Anticipates a potential reversal of certain valuation allowances in Q4 2026, resulting in a material tax benefit.
• Expects diluted ADS outstanding to be approximately 118 million for the full year 2026.

Business Segments and Product Lines:

• BRUKINSA (zanubrutinib) global sales reached $1.4 billion in Q3 2026, a 34% increase YoY; U.S. sales were $1.0 billion (36% increase YoY).
• TEVIMBRA (tislelizumab) global sales were $243 million in Q3 2026, a 28% increase YoY.
• Amgen in-licensed products generated $167 million in global sales in Q3 2026, a 26% increase YoY.
• BRUKINSA received FDA Priority Review designation for the Phase 3 MANGROVE filing.
• Completed Phase 3 MANGROVE regulatory submissions in the EU and China for BRUKINSA.
• TEVIMBRA received Japan regulatory approval for first-line nasopharyngeal cancer.
• Received FDA approval for a TEVIMBRA-based regimen for first-line HER2+ gastroesophageal adenocarcinoma (GEA).
• Tacabrutideg (BTK CDAC) met the primary endpoint of overall response rate in the pivotal Phase 2 portion of the CaDAnCe-101 study for relapsed/refractory CLL.
• BG-75202 (KAT6 A/B inhibitor) enrolled the first patient in a Phase 1 monotherapy study for acute myeloid leukemia.
• BGB-B2033 (GPC3x4-1BB bispecific antibody) received Orphan Drug Designation from the European Commission and an Innovation Passport for hepatocellular carcinoma (HCC).
• BG-85738 (RAS ONi) enrolled the first patient in a Phase 1 study for advanced solid tumors with RAS mutations.
• BG-C477 (CEA ADC) received FDA Fast Track Designation for advanced or metastatic CEA-high non-small cell lung cancer.
• BGB 58067 (MTA-cooperative PRMT5 inhibitor) disclosed first clinical data at ESMO 2026.
• BG-C9074 (B7-H4 ADC) initiated the Starstone-301 Phase 3 study for first-line ovarian cancer.
• Announced a multi-part collaboration with Revolution Medicines for clinical combinations and exclusive regional rights to RAS(ON) inhibitors in select Asian markets.

Market and Competitive Landscape:

• The company reports continued rapid global growth and leadership in hematology.
• Gross margin improvement was driven by a higher sales mix of BRUKINSA compared to other portfolio products.
• Productivity improvements contributed to lower costs for BRUKINSA and TEVIMBRA.

Risks and Challenges:

• A non-cash intangible asset impairment charge of $22 million was recorded related to the decision to discontinue promotion of POBEVCY.
• Forward-looking statements note risks regarding clinical results, regulatory approvals, commercial success, intellectual property protection, and reliance on third parties.

Management Commentary and Tone:

• CEO John V. Oyler stated that strong Q3 results and raised guidance reflect continued rapid global growth anchored by BRUKINSA and the next-generation BCL2 inhibitor BEQALZI.
• Management expressed confidence in multiple catalysts from a deep pipeline spanning hematology and solid tumors, accelerated by differentiated R&D, manufacturing, and commercialization capabilities.
• The tone indicates optimism regarding the pipeline's potential and the company's ability to reach more patients globally.

Other Key Points:

• Announced a voluntary agreement with the U.S. Government to expand access to innovative cancer medicines and strengthen the U.S. manufacturing footprint.
• Renewed a partnership with the BeOne Care Foundation and The Max Foundation to expand access to BRUKINSA for CLL treatment in low- and middle-income countries through 2028.
• 29 abstracts were accepted for presentation at the ASH 2026 Annual Meeting, including interim analysis from the MANGROVE study.
• 10 abstracts were accepted for BEQALZI at ASH 2026.
• 6 abstracts were accepted for Tacabrutideg at ASH 2026.
• Anticipated R&D milestones include a BRUKINSA regulatory submission in Japan for first-line MCL in Q4 2026 and the initiation of the GroundBBreaker-301 Phase 3 study for HCC in Q4 2026.
• China regulatory actions for TEVIMBRA and ZIIHERA in first-line HER2+ GEA are expected in the first half of 2027.