BeOne Medicines (NasdaqGS:BGNE) Q4 2025 Earnings call February 26, 2026 08:00 AM ET Company ParticipantsAaron Rosenberg - CFOAmit Aggarwal - Chief Medical Officer of HematologyDan Maller - VP of Investor RelationsJohn V. Oyler - Co-Founder, Chairman and CEOLai Wang - President and Global Head of Research & DevelopmentMark Lanasa - SVP and Chief Medical OfficerMatt Shaulis - General Manager of North AmericaSean Laaman - Executive DirectorXiaobin Wu - President and COOZhihong Chen - Managing DirectorNone - Co ...

BeOne Medicines (NasdaqGS:BGNE) Q4 2025 Earnings call February 26, 2026 08:00 AM ET Company ParticipantsAaron Rosenberg - CFOAmit Aggarwal - Chief Medical Officer of HematologyDan Maller - VP of Investor RelationsJohn V. Oyler - Co-Founder, Chairman and CEOLai Wang - President and Global Head of Research & DevelopmentMark Lanasa - SVP and Chief Medical OfficerMatt Shaulis - General Manager of North AmericaSean Laaman - Executive DirectorXiaobin Wu - President and COOZhihong Chen - Managing DirectorNone - Co ...

BeOne Medicines (NasdaqGS:BGNE) Q4 2025 Earnings call February 26, 2026 08:00 AM ET Speaker10Good day, everyone. Welcome to BeOne Medicines Q4 and full year 2025 earnings call webcast. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. At this time, I would like to turn the call over to the company.Speaker3Hello and welcome. Thanks for joining us today. I'm Dan Maller, Head of Investor Relations at BeOne Medicines. Be ...

Q4 and Full Year 2025 Results Conference call and webcast for investors and analysts FEBRUARY 26, 2026 Disclosures Certain statements contained in this presentation and in the accompanying oral presentation, other than statements of fact that are independently verifiable at the date hereof, constitute forward looking statements. Examples of such forward-looking statements include statements regarding BeOne's research, discovery, preclinical and clinical programs and plans, including proof of concept timing, ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37686 BEONE MEDICINES LTD. (Exact Name of Registrant as Specified in its Charter) Switzerland 98-1209416 (State or ...

Exhibit 99.1 "These strong financial results for the fourth quarter and full year 2025 underscore our continued evolution as a global oncology leader with durable competitive advantages in clinical development and manufacturing and one of the industry's deepest and most differentiated pipelines," said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. "BRUKINSA has firmly established itself as the global leader in the BTK inhibitor class, distinguished by broad regulatory approvals, expanding geographic ...

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.

Company Performance & Financials - BeOne Medicines delivered significant product revenue growth, with a 43% increase in the first three quarters of 2025 [17] - BRUKINSA rapidly became the global BTKi leader, showing a 51% increase in approved indications [20] - The company's pipeline achieved proof of concept for 6 assets across 4 modalities and brought 5 new molecular entities (NMEs) to the clinic in 2025 [22] CLL Treatment Landscape & BRUKINSA - BRUKINSA demonstrates progression-free survival (PFS) superiority to ibrutinib, with a hazard ratio (HR) of 069 (95% CI: 055, 087), p-value: 00014 [53] - Recent competitor efficacy data does not indicate a change to the CLL treatment landscape, with Pirtobrutinib showing a HR of 0845 (95% CI: 0566-1262), p-value: 04102 [60] - In the ALPINE trial, Zanubrutinib had a lower rate of adverse events (AEs) leading to treatment discontinuation at 77% compared to ibrutinib at 130% [65] ZS (Zanubrutinib + Sonrotoclax) Regimen - ZS (Zanubrutinib + sonrotoclax) is poised to be a fixed duration regimen with a 91% undetectable minimal residual disease (uMRD) rate [74] - ZS showed a 100% 36-month PFS rate (at 30 months) [74] - The company is initiating a Phase 3 trial of ZS vs AV in 1L CLL in H1 2026 [101] Pipeline & Future Milestones - The company has approximately 8-10 new molecular entities (NMEs) per year in its pipeline [105] - BeOne is the only company with best-in-class foundational medicines across the three key mechanisms of action (MOAs) in CLL [99] - The company anticipates several milestones in H1 and H2 2026, including Phase 3 data for BRUKINSA+R vs BR in 1L MCL and a potential R/R MCL U S approval for Sonro [101]

Summary of BeOne Medicines Conference Call Company Overview - **Company**: BeOne Medicines (NasdaqGS:BGNE) - **Key Personnel**: John Euler (CEO), Aaron Rosenberg (CFO), Mark Lanesa (Chief Medical Officer of Solid Tumor) [2][4] Industry Insights - **Sector**: Biotechnology, specifically oncology - **Market Position**: BeOne is recognized as one of the fastest-growing biotech companies, achieving profitability and leading global revenue with its BTK inhibitor, Brukenza [2][4] Core Strategies and Unique Infrastructure - **R&D Approach**: BeOne has built its own infrastructure, termed the "B1 global superhighway," consisting of 6,000 personnel globally, with 2,000 in manufacturing and 4,000 in clinical trials across 40-50 countries [4][5] - **Cost Efficiency**: The company aims to reduce the high costs associated with clinical trials, which typically account for 75-90% of oncology medicine expenses [4][5] - **Research Output**: In the last two years, BeOne has introduced 16 new molecular entities into clinical trials, with a focus on hematology and solid tumors [5][6] Financial Performance - **Revenue Breakdown**: As of Q3 2025, 52% of revenue is from the U.S., with European sales growing 71% year-over-year, now accounting for 12% of total sales. The rest of the world saw a 133% year-over-year growth [11][12] - **Manufacturing Investment**: Over $800 million has been invested in a biologics facility in New Jersey, which will support production for Tovembara, a PD-1 therapy [14] CLL Franchise - **Key Products**: Brukenza is the leading BTK inhibitor globally, with a six-year milestone PFS of 74%, outperforming other monotherapy BTKs [15][16] - **Clinical Strategy**: BeOne is conducting head-to-head trials against competitors to validate the efficacy of its therapies [23][24] - **Future Prospects**: Anticipated approvals for Synrodoclaix in 2026 and the BTK degrader in 2027, aiming to expand treatment options for CLL patients [29] Solid Tumor Pipeline - **CDK4 Inhibitors**: BeOne plans to initiate a phase three trial for a CDK4 inhibitor in frontline HR-positive HER2-negative breast cancer, expecting superior PFS compared to existing treatments [30][32] - **PRMT5 Inhibitor**: The PRMT5 inhibitor is noted for its potency and CNS penetration, showing promise in various tumor types [33][34] Degrader Platforms - **BTK Degrader**: The BTK degrader is in phase three studies, with additional programs for KRAS and EGFR degraders progressing well [36][37] R&D Investment Strategy - **Financial Discipline**: BeOne aims for sustainable growth while maintaining a high bar for R&D investments, with $125 million in net income and $354 million in free cash flow reported [39][40] AI in Drug Development - **AI Utilization**: BeOne is exploring AI for drug discovery and clinical trials, recognizing the potential for improved efficiency but acknowledging challenges due to fragmented data [42][45] Conclusion - BeOne Medicines is positioned as a leader in the biotech sector with a robust pipeline, innovative R&D strategies, and a commitment to expanding its global footprint while maintaining financial discipline and exploring new technologies like AI for drug development.

Investment Rating - The report indicates a positive outlook for Chinese stocks, with Goldman Sachs expecting 10.4% annualized total returns over the next decade [1]. Core Insights - The report highlights that MXCN gained 1% while A-shares slipped 1%, with October credit and activity data broadly missing expectations [1]. - The PBOC adopted a less dovish tone in its Q3 monetary policy report, leading to a revision in policy rate cut expectations [1]. - The report notes that Alibaba is launching the "Qwen" personal AI assistant project to compete with ChatGPT, indicating a focus on technological advancements [1]. - Southbound Connect saw US$3.2 billion inflows this week, reflecting investor interest in Chinese equities [1]. - Real export growth is expected to be 5-6% year-on-year in the coming years, despite uncertainties surrounding US tariff policies [1]. Performance Summary - MXCN/CSI300 12-month forward P/Es are reported at 13.0x and 14.6x respectively, with EPS growth estimates for 2025/26 at 2%/16% for MXCN and 14%/14% for CSI300 [8]. - The report emphasizes that AI beneficiaries have significantly contributed to North Asia's year-to-date performance, with Taiwan, Korea, and China showing strong gains [11]. - The report suggests that A shares are likely to modestly outperform H shares in the next three months [22]. Sector and Market Insights - The report identifies key sectors for investment, favoring Internet/Media/Entertainment, Consumer Retail & Durables, and Tech Hardware & Semiconductors, while being underweight on Telecom Services and Utilities [10]. - The macro backdrop is seen as favorable for global and domestic cyclicals along with dollar-sensitive sectors [10]. - The report indicates that 83% of all China-listed companies have reported earnings so far, with 9M/3Q25 earnings rising 6%/11% year-on-year [20].