BeOne Medicines (ONC) Investor Update summary

Strategic approach and pipeline evolution

• Focuses on early-stage discovery, rapid clinical proof of concept, and disciplined late-stage development, supported by 1,100 researchers and a CRO-free, tech-enabled model for speed and cost efficiency.

• Leverages advanced technology platforms, including degraders, ADCs, bispecifics, and innovative modalities such as small molecules, biologics, cell therapy, and mRNA, to address undruggable targets and diversify the portfolio.

• Pipeline has rapidly expanded, with 16 novel molecules entering the clinic in 18 months since 2020 and 69 preclinical programs as of November 2024.

Solid tumor and breast cancer franchise updates

• CDK4 selective inhibitor BGB-43395 shows rapid enrollment, favorable PK, low hematologic toxicity, and promising early efficacy in HR+/HER2- breast cancer.

• Early pharmacodynamic data indicate strong and sustained TK1 suppression, supporting further development and phase 3 planning in first- and second-line HR+ breast cancer.

• Five abstracts presented at SABCS, including first clinical data for BGB-43395 and progress on CDK2 and B7-H4 ADC programs.

• The breast/gynecologic portfolio leverages CDK4i as a backbone for combination therapies across multiple lines and tumor types.

Hematology and CLL leadership

• BRUKINSA (zanubrutinib) maintains best-in-class status with broad global approval, superior efficacy, and favorable safety profile in CLL, including high-risk subgroups and low rates of atrial fibrillation and hypertension.

• Sonrotoclax, a potent BCL2 inhibitor, demonstrates deep, durable responses and is advancing in pivotal trials for CLL and other B-cell malignancies, with best-in-class potential and improved safety.

• BTK degrader (CDAC/BGB-16673) shows high response rates and durable efficacy in heavily pretreated, high-risk CLL and other B-cell malignancies, including those with BTKi resistance, with a favorable safety profile.

• Combination regimens such as BOVen and sonrotoclax+zanubrutinib achieve high uMRD rates and deep, durable responses in TN CLL, with manageable safety and no tumor lysis syndrome.

• Multiple presentations at ASH highlight sustained efficacy, high MRD negativity, and safety across cornerstone assets.