BeOne Medicines (ONC) investor relations material

Financial performance and guidance

• Revenue guidance for 2026 is set at $6.2–$6.4 billion, reflecting $1 billion year-over-year growth, with confidence in continued momentum from strong Q4 results and global demand creation.

• Growth is driven by strong performance in China and the U.S., with BRUKINSA established as the top BTK globally and significant sequential growth in Q4; Europe and rest of world are earlier in the launch cycle but show rapid expansion.

• Seasonality affects quarterly performance, with Q2 and Q4 typically strongest in the U.S., while China and other regions have different patterns; Q1 is impacted by insurance resets and fewer shipment weeks.

• R&D expenses are increasing but revenue growth is outpacing OpEx, supporting margin expansion and profitability, with over $940 million in free cash generated in 2025.

• The company maintains flexibility in asset partnerships, leveraging a strong balance sheet to advance most programs internally while evaluating value-maximizing options for each asset.

Pipeline and clinical development

• Over 200 early-phase cohorts were progressed in 2024–2025 at a median of 6–7 weeks per cohort, with six or seven programs discontinued for not meeting internal criteria.

• Five programs have a clear path to registrational studies, including assets like BG-T187 (EGFR MET trispecific) and FGFR2b ADC, with high success rates expected for transition from early to late development.

• The CDK4 inhibitor (BGB-43395) phase III trial is designed for head-to-head superiority over CDK4/6, with operational excellence expected to expedite progress; combination strategies with SERDs and PIK3CA inhibitors are under consideration.

• Data disclosures for CDK4, B7H4, and GPC3-41BB are planned for Q2, while PRMT5 and CEA-ADC data will be shared in the second half of the year; IRAK4 CDAC data in rheumatoid arthritis is also expected later in the year.

• The GPC3-41BB bispecific has shown promising responses in HCC with a favorable safety profile, earning FDA fast track designation and moving toward registrational studies; CEA-ADC is showing responses across colorectal, gastric, and lung cancers.

Hematology pipeline and competitive positioning

• Sonrotoclax, a next-generation BCL-2 inhibitor, is more potent and selective than venetoclax, with a shorter half-life, aiming to improve usability and expand the market, especially in community settings.

• Early data for zanubrutinib and sonrotoclax combination show high MRD rates and strong PFS, with no deaths due to adverse events; phase III in multiple myeloma is planned for 2026.

• Initial U.S. approval for sonrotoclax is expected in MCL in the first half of the year, with China already approved for several indications.

• The BTK degrader is positioned for later-line use, with head-to-head phase III trials against Jaypirca and investigator choice underway; operational and molecular advantages are claimed over competitors like Nurix.

• The company is open to moving the degrader into earlier lines or combinations, but remains committed to frontline BRUKINSA and exploring potent later-line combinations.