Summary of BeOne Medicines FY Conference Call Company Overview - **Company**: BeOne Medicines (NasdaqGS:BGNE) - **Event**: 46th Annual Healthcare Conference from TD Cowen - **Date**: March 02, 2026 Key Points Financial Guidance and Revenue - **Revenue Guidance**: BeOne Medicines provided a revenue guidance of **$6.2 billion to $6.4 billion** for FY 2026, reflecting a **$1 billion year-over-year growth** [6][9] - **Q4 Performance**: The company reported a strong exit from Q4, with significant growth across all geographies, particularly in the US and China markets [7][13] - **Market Dynamics**: The guidance considers competitive dynamics, including stable net pricing in the US market [8][12] Competitive Landscape - **Competitors**: The company acknowledged competition from AVEO and Jaypirca, noting that AVEO was not approved, which positively impacts BeOne's market position [11] - **Market Leadership**: BRUKINSA was established as the **number 1 BTK globally** in 2025, with a **14% sequential growth** in Q4 compared to Q3, while competitors grew by only **4%** [13][14] Regional Growth - **US and China**: Strong growth was noted in both the US and China, with BRUKINSA leading in these markets [13] - **Europe and Rest of World**: The European business nearly tripled in 2024 and grew over **70%** in 2025, while the rest of the world markets grew by more than **100%** [14] Research and Development (R&D) - **Pipeline Expansion**: The company is expanding its pipeline with multiple programs in various phases, including BCL-2 and BTK degrader [20][24] - **Investment Strategy**: BeOne Medicines is committed to both growth and margin expansion, having generated over **$940 million in free cash** in 2025 [24] - **Partnership Considerations**: The company is evaluating potential partnerships for certain assets but has the capability to develop most of its programs independently [26] Clinical Trials and Drug Development - **CDK4 Program**: The CDK4 program is set to start trials, with a focus on operational excellence and rapid enrollment [35][38] - **GPC3 and CEA-ADC**: The GPC3 ADC has shown promising results, with FDA granting Fast Track designation, and plans for registrational studies are underway [51][55] - **B7H4 ADC**: The B7H4 ADC is in development, with initial studies planned for breast or gynecologic cancers [57][62] Market Potential and Strategy - **BCL-2 Class**: The BCL-2 class, particularly with sonrotoclax, is expected to unlock significant market potential due to its usability and safety profile compared to existing treatments like Venetoclax [73][74] - **Multiple Myeloma Opportunity**: Plans to initiate a phase 3 study in multiple myeloma are in place, targeting patients with specific genetic translocations [76] Future Outlook - **Regulatory Engagement**: The company is actively engaging with regulatory authorities to expedite the development of its promising candidates [51] - **Data Disclosures**: BeOne Medicines plans to share data from various programs at major medical congresses throughout the year, indicating a robust pipeline and ongoing commitment to transparency [43][55] Additional Insights - **Operational Efficiency**: The company has demonstrated a high success rate in moving molecules from early to late-stage development, with a focus on stopping underperforming programs [31] - **Innovative Approaches**: BeOne Medicines is leveraging its unique clinical development model to enhance efficiency and reduce costs in drug development [23] This summary encapsulates the key insights and strategic directions discussed during the conference call, highlighting BeOne Medicines' strong market position, growth potential, and commitment to innovation in oncology.

Financial Data and Key Metrics Changes - In Q4 2025, product revenue reached $1.5 billion, representing a 32% year-over-year growth [24] - BRUKINSA global revenues totaled $1.1 billion in Q4, growing 38%, with full-year revenues of $3.9 billion, a 49% increase [24] - Gross margin improved to 87% from approximately 84% in the prior year, reflecting favorable product mix and cost efficiencies [26][27] - Operating expenses grew by 12% to $4.2 billion, with income from operations totaling $447 million, showcasing profitability [28] Business Line Data and Key Metrics Changes - BRUKINSA established itself as the leading BTK inhibitor globally, with U.S. sales of $845 million in Q4, driven by a volume growth of approximately 30% [24] - TEVIMBRA reported an 18% increase in revenue, reflecting continued market leadership in China [25] - In-licensed products showed a 9% year-over-year growth, contributing to solid execution across geographies [25] Market Data and Key Metrics Changes - The U.S. remains the largest market, generating $850 million with a year-over-year growth of 38% [25] - China revenue totaled $399 million, an 11% increase compared to Q4 2024, supported by market leadership of TEVIMBRA and BRUKINSA [26] - Europe contributed $174 million, with a 53% year-over-year growth, as BRUKINSA continues its launch trajectory [26] Company Strategy and Development Direction - The company aims to deepen its leadership in CLL and expand across hematological malignancies and solid tumors [37] - Plans to advance one to two cornerstone immunology assets towards registration, indicating a strategic shift towards immunology [37] - The company believes it can move faster and achieve better outcomes across other diseases, leveraging its foundational CLL franchise [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the differentiated value proposition of BRUKINSA, emphasizing its safety profile and long-term efficacy [52] - The company anticipates continued strong demand growth in the U.S. with stable net pricing, projecting 2026 revenue between $6.2 billion and $6.4 billion [30] - Management highlighted the importance of addressing unmet medical needs with new product launches, including sonrotoclax and zanidatamab [30] Other Important Information - The company reported a non-recurring $40 million equity investment impairment in Q4, impacting net income [28] - Free cash flow was over $940 million for the full year 2025, indicating strong cash generation [29] - The company is optimistic about the potential of its new pipeline assets, including a proprietary off-the-shelf iPSC-derived gamma delta T-cell therapy [40] Q&A Session Summary Question: Potential net pricing development in the BTK inhibitor market - Management emphasized BRUKINSA's differentiated value proposition and its best-in-class status, which should mitigate pricing pressures from competitors entering the market [51][52] Question: Guidance assumptions regarding competition from AV or Jaypirca - Management noted that AV's clinical profile does not meet the standards for treatment in CLL, and they remain confident in BRUKINSA's position [56] Question: Strategy for immunology pipeline development - The company aims to identify 1 or 2 cornerstone assets in immunology over the next few years, with a focus on being first or best in class [61][63] Question: Impact of ZS becoming the fixed duration regimen of choice on BRUKINSA revenues - Management explained that the combination of sonrotoclax and zanubrutinib would open up a new market segment, potentially expanding overall market share [68][70] Question: Update on BTK degrader approval timeline - Management confirmed that there has been no change in the timing for the BTK degrader's approval, with plans to interact with the FDA midyear [76]

Financial Data and Key Metrics Changes - In Q4 2025, product revenue reached $1.5 billion, representing a 32% year-over-year growth [24] - BRUKINSA global revenues totaled $1.1 billion in Q4, growing 38%, with full-year revenues of $3.9 billion, reflecting a 49% increase [24][30] - Gross margin improved to 87% from approximately 84% in the prior year, driven by favorable product mix and cost efficiencies [26][27] - Operating expenses grew by 12% to $4.2 billion, while income from operations totaled $447 million, indicating profitability [28] Business Line Data and Key Metrics Changes - BRUKINSA established itself as the leading BTK inhibitor globally, with a significant gap widening against competitors [6] - TEVIMBRA reported an 18% increase in revenue, reflecting continued market leadership in China [25] - In the U.S., BRUKINSA sales in Q4 were $845 million, driven by volume growth of approximately 30% [24] Market Data and Key Metrics Changes - The CLL market is valued at $12 billion and is growing due to therapeutic innovations [7] - China revenue totaled $399 million, an 11% increase compared to Q4 2024, supported by market leadership of TEVIMBRA and BRUKINSA [26] - Europe contributed $174 million, with 53% year-over-year growth, as BRUKINSA continues its launch trajectory [26] Company Strategy and Development Direction - The company aims to deepen its leadership in CLL and expand into hematological malignancies and solid tumors [37] - Plans include advancing one to two cornerstone immunology assets towards registration [37] - The company is focused on developing a more efficacious fixed-duration regimen that addresses unmet needs in the market [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the differentiated value proposition of BRUKINSA, emphasizing its safety and efficacy compared to competitors [52] - The company anticipates continued strong demand growth in the U.S. and stable net pricing, projecting 2026 revenue between $6.2 billion and $6.4 billion [30][31] - Management highlighted the importance of addressing the unmet needs in the CLL market and the potential for BRUKINSA to serve as a foundational therapy [38] Other Important Information - The company achieved significant product revenue growth, GAAP profitability, and meaningful cash flow generation in 2025 [6] - The R&D pipeline saw major advancements, with five assets achieving clinical proof of concept in 2025 [34] - The company is leveraging AI and automation to enhance clinical trial execution and data analysis [46] Q&A Session Summary Question: Can you comment on potential net pricing development in the BTK inhibitor market? - Management highlighted BRUKINSA's differentiated value proposition and its best-in-class status, indicating confidence in maintaining its market position despite competitive pressures [52] Question: What are the assumptions regarding competition from AV or Jaypirca? - Management noted that AV was studied in a limited patient population and expressed confidence in BRUKINSA's clinical profile, suggesting that AV does not meet the necessary treatment criteria [56] Question: Can you elaborate on the strategy for immunology beyond hematology and solid tumors? - Management indicated that approximately 20% of their assets are focused on immunology, with plans to identify one or two cornerstone assets in the next 2-3 years [62] Question: How will the introduction of ZS as a fixed-duration regimen affect BRUKINSA's revenues? - Management explained that the combination of sonrotoclax and zanubrutinib would open up a new market segment, allowing for growth without sacrificing existing revenues from continuous use [68]

Financial Data and Key Metrics Changes - In Q4 2025, product revenue reached $1.5 billion, representing a 32% year-over-year growth [23] - BRUKINSA global revenues totaled $1.1 billion in Q4, growing 38%, with full-year revenues of $3.9 billion, a 49% increase [23] - Gross margin improved to 87% from approximately 84% in the prior year, driven by favorable product mix and cost efficiencies [25] - Operating expenses grew by 12% to $4.2 billion, while income from operations totaled $447 million, indicating profitability [26] - Non-GAAP net income for 2025 was $918 million, translating to diluted non-GAAP earnings per ADS of $8.09 [27] Business Line Data and Key Metrics Changes - BRUKINSA established itself as the leading BTK inhibitor globally, capturing approximately half of the continuous BTK segment of the market [21] - TEVIMBRA reported an 18% increase in revenue, reflecting continued market leadership in China [24] - In the U.S., BRUKINSA sales in Q4 were $845 million, driven by volume growth of approximately 30% [23] - China revenue totaled $399 million, an 11% increase, supported by TEVIMBRA and BRUKINSA's market leadership [25] Market Data and Key Metrics Changes - The CLL market is valued at $12 billion and is growing due to therapeutic innovations [5] - The U.S. remains the largest market for BRUKINSA, generating $850 million with year-over-year growth of 38% [24] - Europe contributed $174 million, with 53% year-over-year growth, as BRUKINSA continues its launch trajectory [25] - Rest of world markets grew 74%, driven by market expansion and new launches [25] Company Strategy and Development Direction - The company aims to deepen its leadership in CLL with three foundational medicines and expand into hematological malignancies and solid tumors [35] - Plans include advancing one to two potential cornerstone immunology assets towards registration [35] - The company is focused on developing a more efficacious, time-limited regimen that addresses unmet needs in the CLL market [19] - The strategy includes leveraging the differentiated clinical data of BRUKINSA to maintain a competitive edge [48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued demand for BRUKINSA and stable net pricing in the U.S. market [28] - The company anticipates revenue growth between $6.2 billion and $6.4 billion for 2026, driven by global expansion and new product launches [29] - Management highlighted the importance of clinical data in establishing BRUKINSA as a best-in-class product [48] Other Important Information - The company initiated three phase 3 studies for its BTK degrader and made significant progress in solid tumors [33] - The company is advancing a proprietary off-the-shelf iPSC-derived gamma delta T-cell therapy, which is designed to overcome limitations of existing therapies [38] - The global clinical development superhighway is a core competitive advantage, enabling faster and more efficient clinical trials [42] Q&A Session Summary Question: Can you comment on potential net pricing development in the BTK inhibitor market? - Management emphasized BRUKINSA's differentiated value proposition and its best-in-class status, which supports its pricing strategy despite competition [47][48] Question: What are the assumptions regarding competition from AV or Jaypirca? - Management expressed confidence in BRUKINSA's clinical profile and its positioning against competitors, noting that AV does not meet the necessary treatment standards [50][52] Question: Can you clarify the strategy for immunology beyond hematology and solid tumors? - Management indicated that about 20% of their assets are focused on immunology, with plans to identify one or two cornerstone assets in the next 2-3 years [57][59] Question: How will ZS impact continuous BRUKINSA revenues if it becomes the fixed duration regimen of choice? - Management explained that the combination of sonrotoclax and zanubrutinib would open up a new market segment, expanding overall market opportunities rather than cannibalizing existing revenues [61][63] Question: What is the status of the BTK degrader and its potential approval timeline? - Management confirmed that there has been no change in the timing for the BTK degrader's approval, with plans to interact with the FDA midyear [70][71]

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, ...

Core Insights - BeOne Medicines AG (NASDAQ:ONC) is highlighted as a promising healthcare stock for 2026, showcasing significant advancements in its pipeline development [1] Pipeline Development - The company’s BRUKINSA, a tyrosine kinase inhibitor, has demonstrated a 74% six-year progression-free survival rate in treatment-naïve chronic lymphocytic leukemia (CLL), significantly outperforming the 32% rate of bendamustine plus rituximab [2] - Sonrotoclax, a BCL2 inhibitor, has received regulatory approval with an impressive overall response rate of 86% in heavily pretreated CLL patients [2] - BeOne Medicines is advancing 15 new molecular entities into clinical trials and plans to introduce an additional 8 to 10 candidates [2] Market Performance and Projections - Citizens has reiterated a Market Perform rating for BeOne Medicines with a price target of $396, citing strong efficacy data from a phase 3 trial in gastric cancer patients [3] - The anticipated approval of sonrotoclax is expected to lead to further global approvals, while Brukinsa is projected to generate $3.8 billion in revenue by 2025 [3] Company Overview - BeOne Medicines AG is a biotechnology firm focused on the discovery, development, and commercialization of innovative and affordable oncology treatments, known for products like Brukinsa and Tevimbra [4]

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]

Core Viewpoint - BeiGene (06160) reported a 43.3% increase in Q3 revenue to $3.8 billion, with adjusted net profit of $693 million, exceeding both the firm's and market expectations [2] Financial Performance - Q3 revenue reached $3.8 billion, marking a 43.3% year-over-year increase [2] - Adjusted net profit was $693 million, surpassing expectations [2] Future Guidance - The company raised its revenue guidance for 2025 while slightly lowering cost forecasts [2] - Strong sales outlook for BRUKINSA and improved operational efficiency are expected to drive steady profit and cash flow growth [2] Research and Development - Efficient R&D progress is anticipated to support future product launches, contributing to sustainable long-term growth [2] Investment Rating - The stock maintains a "Buy" rating, with the H-share target price increased from HKD 240 to HKD 252 [2]

Core Viewpoint - BeiGene (06160) reported a 43.3% increase in Q3 revenue to $3.8 billion, with adjusted net profit of $693 million, exceeding both the firm's and market expectations [1] Financial Performance - Q3 revenue increased by 43.3% to $3.8 billion [1] - Adjusted net profit reached $693 million, surpassing expectations [1] Future Guidance - The company raised its revenue guidance for 2025 while slightly lowering cost forecasts [1] - Strong sales outlook for BRUKINSA and improved operational efficiency are expected to drive steady profit and cash flow growth [1] Research and Development - Efficient R&D progress is anticipated to support sustainable long-term growth through future product launches [1] Stock Rating - The stock is maintained with a "Buy" rating, and the target price for H-shares has been raised from HKD 240 to HKD 252 [1]