Summary of BeOne Medicines FY Conference Call Company Overview - **Company**: BeOne Medicines (NasdaqGS:BGNE) - **Industry**: Biotechnology, specifically focused on oncology and cancer treatment Key Points and Arguments Financial Performance - BeOne achieved significant product revenue growth, GAAP profitability, and meaningful cash flow generation in 2025, fulfilling commitments made at the previous conference [4][32] - Generated over $350 million in free cash flow in Q3 2025 and has a solid balance sheet with over $4 billion in cash [32] Product Development and Pipeline - **BRUKINSA**: Became the number one BTK inhibitor in the U.S. and globally, setting a new standard for efficacy and safety in Chronic Lymphocytic Leukemia (CLL) treatment with six-year progression-free survival (PFS) and overall survival (OS) rates of 74% and 84%, respectively [4][9] - **Sonro**: Received breakthrough designation and priority review in the U.S. for relapsed Mantle Cell Lymphoma (MCL) and had four regulatory approval submissions in 2025 [4] - **Tisli-Zanny**: Positive results in first-line HER2-positive gastric cancer, showing clinically meaningful improvement over standard care [5] - **Pipeline Expansion**: Five new molecules entered clinical trials, and six assets achieved proof of concept across four modalities [5] Market Insights - The CLL market is currently valued at $12 billion and is expected to grow due to therapeutic innovations [5][36] - Continuous BTK therapy is currently dominated by three major players, with BeOne positioned as the number one player [37] Safety and Efficacy Comparisons - BRUKINSA demonstrated superior efficacy and a more favorable safety profile compared to Ibrutinib and Acala, addressing issues such as cardiac toxicity [9][16] - Fixed-duration therapies currently available have shown underwhelming efficacy and safety concerns, which may limit their adoption [17][19] Future Outlook - BeOne plans to continue its focus on innovation, with expectations for a milestone-rich 2026, including phase three data from the Brukinza-Mangrove trial and initial global launches for Sonro [26][32] - The company aims to redefine treatment paradigms in CLL with a combination of BRUKINSA and a more selective BCL-2 inhibitor, Sonrotoclax, which is expected to deliver on the promise of fixed-duration therapy [21][22] R&D Capabilities - BeOne has a large R&D team of approximately 4,800 people, making it one of the largest oncology-focused teams globally [26] - The company has a unique integrated in-house model for drug development, which enhances speed and efficiency compared to traditional CRO-based models [30] Additional Important Insights - The company emphasizes the importance of patient stories, such as that of Lynn, a CLL patient thriving on BRUKINSA, highlighting the human impact of their innovations [10][11] - BeOne's commitment to addressing unmet medical needs in both frontline and relapse settings is evident in their development of a first-in-class BTK CDAC for relapsed CLL [23][24] This summary encapsulates the critical aspects of BeOne Medicines' FY conference call, focusing on financial performance, product development, market insights, safety comparisons, future outlook, and R&D capabilities.

Summary of BeOne Medicines FY Conference Call Company Overview - **Company**: BeOne Medicines (NasdaqGS:BGNE) - **Industry**: Biotechnology - **Key Achievement**: First year of profitability and recognized as one of the fastest-growing large biotech companies [3][4] Competitive Advantages - **Integrated Development**: Fully integrated CRO-free clinical development organization with over 3,600 professionals [4] - **Product Pipeline**: Deep product pipeline with 10 internally developed New Molecular Entities (NMEs) entering the clinic in 2024 and 16 to date [3] - **Cost Efficiency**: 70% of the cost to develop medicines is in clinical development; BeOne aims to reduce this through its integrated approach [4] Product Performance - **Brukinsa**: - Leading market share in the BTK inhibitor market with 47% year-over-year growth in the U.S. and 71% growth in Europe [6][8] - Demonstrated durable progression-free survival (PFS) with 74% landmark PFS at 72 months [6][7] - Significant real-world impact and prescription growth globally [8][9] Market Dynamics - **Fixed Duration Treatments**: - BeOne supports finite treatments that meet four criteria: deep response, sustained PFS, acceptable safety profile, and convenience [10][11] - Current market dynamics show continuous use BTK inhibitors capturing about 50% of the market, with opportunities for growth through fixed-duration offerings [11][12] Pipeline Developments - **Sonrotoclax**: - Designed to be more potent and selective than venetoclax, with a half-life of five hours [14][15] - Breakthrough designation in relapsed refractory MCL, with plans for global filing based on upcoming data [30] - Phase 3 study planned for multiple myeloma, targeting the translocation 11;14 population [32][33] - **BDK CDAC**: - A degrader molecule with a different mechanism, potentially effective against mutations that standard inhibitors cannot target [24][25] - Phase 2 cohort fully enrolled, with data expected in the first half of next year [26] Competitive Landscape - **Comparison with Competitors**: - BeOne's zanubrutinib shows superior response rates compared to pirtobrutinib and acalabrutinib in specific patient populations [20][21] - Ongoing head-to-head studies to validate BeOne's offerings against competitors [16][17] Future Outlook - **Clinical Trials**: - Upcoming data presentations at ASH for various products, including BDK CDAC and sonrotoclax [28][29] - Commitment to advancing solid tumor pipeline, particularly CDK4/6 inhibitors, with a focus on first-line breast cancer [34][36] Conclusion - BeOne Medicines is positioned strongly within the biotechnology sector with a robust product pipeline, innovative clinical development strategies, and a commitment to addressing patient needs through differentiated therapies. The company is actively pursuing growth opportunities in both hematology and solid tumors while maintaining a competitive edge against established players in the market.