BeOne Medicines (ONC) investor relations material

Clinical strategy and pipeline prioritization

• Five cornerstone solid tumor programs prioritized for phase III, with three highlighted at ASCO and three deprioritized due to unmet criteria.

• Go/no-go decisions are based on clear, indication-specific criteria for differentiation, efficacy, and safety established at first-in-human studies.

• CDK4 and GPC3 programs exceeded go criteria, showing strong efficacy and favorable safety, supporting advancement to phase III.

• Global development model enables rapid, robust data generation across regions, ensuring regulatory alignment and minimizing regional bias.

• Business development is globally focused, leveraging innovation from China and other regions, with recent deals in IO and trispecifics.

Financial performance and guidance

• Upgraded 2026 EBIT guidance from $750M to $850M, with Q1 EBIT at $250M, reflecting strong operating leverage.

• Full-year revenue guidance raised by $100M to $6.3B–$6.5B, with GAAP operating income guidance up by $50M to $800M–$850M.

• Continued investment in commercial and clinical opportunities, with OpEx guidance affirmed for the year.

Product performance and market expansion

• BRUKINSA is the global leader in BTK inhibitors, with over 35% global share and strong growth in the US, EU, and rest-of-world markets.

• European BRUKINSA sales grew ~60%, outpacing US growth due to earlier launch stage; rest-of-world markets doubled in Q1.

• SEQUOIA data at ASCO showed 72% PFS at 6.5 years, supporting continued market uptake.