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 Ltd. reported a revenue of $1.41 billion for the quarter ended September 2025, reflecting a 41% increase year-over-year and a surprise of +5.36% over the Zacks Consensus Estimate of $1.34 billion [1] - The company's EPS for the quarter was $1.09, a significant improvement from -$1.15 in the same quarter last year, resulting in an EPS surprise of +51.39% compared to the consensus estimate of $0.72 [1] Revenue Breakdown - Product Revenue from TEVIMBRA was $190.62 million, slightly below the average estimate of $198.95 million from three analysts [4] - Product Revenue from BRUKINSA (Zanubrutinib) reached $1.04 billion, exceeding the three-analyst average estimate of $1.01 billion [4] - Net product revenues totaled $1.4 billion, surpassing the average estimate of $1.35 billion and representing a +40.4% change compared to the year-ago quarter [4] - Product Revenue from KYPROLIS was $18.37 million, below the average estimate of $20.11 million based on two analysts [4] - Product Revenue from BLINCYTO was $30.48 million, exceeding the two-analyst average estimate of $25.67 million [4] - Product Revenue from POBEVCY was $10.5 million, below the two-analyst average estimate of $12.33 million [4] - Product Revenue from Other sources was $20.11 million, slightly above the average estimate of $17.76 million from two analysts [4] - Product Revenue from XGEVA was $84.24 million, significantly above the average estimate of $66.23 million based on two analysts [4] Stock Performance - Over the past month, shares of BeOne Medicines Ltd. have returned -8.5%, contrasting with the Zacks S&P 500 composite's +1.3% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Core Insights - BeOne Medicines Ltd. reported a revenue of $1.41 billion for the quarter ended September 2025, marking a 41% increase year-over-year and exceeding the Zacks Consensus Estimate by 5.36% [1] - The company's EPS for the quarter was $1.09, a significant improvement from -$1.15 in the same quarter last year, resulting in an EPS surprise of 51.39% compared to the consensus estimate of $0.72 [1] Revenue Breakdown - Product Revenue from TEVIMBRA was $190.62 million, slightly below the estimated $198.95 million [4] - Product Revenue from BRUKINSA (Zanubrutinib) reached $1.04 billion, surpassing the average estimate of $1.01 billion [4] - Net product revenues totaled $1.4 billion, representing a 40.4% increase compared to the previous year and exceeding the estimated $1.35 billion [4] - Product Revenue from KYPROLIS was $18.37 million, below the average estimate of $20.11 million [4] - Product Revenue from BLINCYTO was $30.48 million, exceeding the average estimate of $25.67 million [4] - Product Revenue from POBEVCY was $10.5 million, below the average estimate of $12.33 million [4] - Product Revenue from Other sources was $20.11 million, slightly above the estimated $17.76 million [4] - Product Revenue from XGEVA was $84.24 million, significantly higher than the average estimate of $66.23 million [4] Stock Performance - Over the past month, BeOne Medicines Ltd. shares have returned -8.5%, contrasting with the Zacks S&P 500 composite's +1.3% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [3]

Investment Rating - The report maintains a "Buy" rating for the company and raises the target prices for its US, Hong Kong, and A-shares [1][10]. Core Insights - The company's Q2 2025 performance exceeded expectations, leading to a slight upward revision of its 2025 revenue, gross margin, and cash flow guidance [1][3]. - The strong performance is attributed to better-than-expected overseas sales of Zepzelca, particularly in the US market, which is the largest driver of growth [2][4]. Financial Performance Summary - Q2 2025 total revenue reached $1.315 billion, representing a 41.6% year-over-year increase and a 17.7% quarter-over-quarter increase, with product revenue at $1.302 billion [2]. - The GAAP operating profit was $87.89 million, and the adjusted operating profit was $275 million, both exceeding previous expectations [2]. - The GAAP net profit was $94.32 million, with an adjusted net profit of $253 million, marking two consecutive quarters of positive GAAP operating profit and net profit [2]. - The product gross margin improved to 87.4%, up 2.4 percentage points year-over-year and 2.2 percentage points quarter-over-quarter [2]. Guidance Adjustments - The company slightly raised its 2025 total revenue guidance from $4.9-5.3 billion to $5-5.3 billion, and the GAAP gross margin guidance from the mid-range of 80%+ to the upper mid-range [3]. - The cash flow guidance was adjusted from positive operating cash flow to positive free cash flow, while GAAP operating expenses and operating profit guidance remain unchanged [3]. Sales Performance - Zepzelca's sales in Q2 2025 reached $950 million, a 49% year-over-year increase and a 20% quarter-over-quarter increase, with US sales being the primary growth driver [4]. - US sales of Zepzelca amounted to $684 million, reflecting a 42.7% year-over-year increase and a 21.4% quarter-over-quarter increase [4]. - European sales reached $150 million, up 84.9% year-over-year, while sales in China grew to $83.3 million, a 31% year-over-year increase [4]. Research and Development Outlook - The company has a rich pipeline of catalysts expected in the second half of 2025 and 2026, including multiple NDA submissions and clinical trial initiations for various products [9].

Group 1 - BeOne Medicines Ltd. reported $1.32 billion in revenue for the quarter ended June 2025, a year-over-year increase of 41.6% [1] - The earnings per share (EPS) for the same period was $0.84, compared to -$1.15 a year ago, indicating a significant turnaround [1] - The reported revenue exceeded the Zacks Consensus Estimate of $1.24 billion by 6.17%, and the EPS surprise was 75% above the consensus estimate of $0.48 [1] Group 2 - Key product revenue included BRUKINSA at $949.84 million, TEVIMBRA at $193.52 million, and total product revenue net at $1.3 billion, all surpassing analyst estimates [4] - Collaboration revenue reached $13.22 million, a 64.9% increase compared to the year-ago quarter, exceeding the average estimate of $7.59 million [4] - Other notable product revenues included KYPROLIS at $19.42 million, BLINCYTO at $25.59 million, and XGEVA at $81.32 million, all of which met or exceeded analyst expectations [4] Group 3 - BeOne Medicines Ltd. shares have returned +25.7% over the past month, significantly outperforming the Zacks S&P 500 composite's +0.5% change [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Financial Performance - BeOne reported Q2 2025 revenue of $1.3 billion, a 42% year-over-year increase[13] - BRUKINSA U S revenue reached $684 million, representing a 43% year-over-year growth[16] - TEVIMBRA revenue increased by 22% year-over-year[45] - GAAP earnings per ADS were $0.84, while non-GAAP earnings per ADS were $2.25[13] - GAAP operating cash flow was $264 million, and free cash flow was $220 million[13] BRUKINSA Highlights - BRUKINSA is the U S revenue leader among BTK inhibitors and the fastest-growing brand[15] - BRUKINSA demonstrated an overall response rate (ORR) ranging from 76.3% to 88.4% across different follow-up periods in the ALPINE trial[23] - In the ALPINE trial, BRUKINSA showed progression-free survival (PFS) superiority over ibrutinib in relapsed/refractory CLL patients, with a hazard ratio of 0.66 (95% CI: 0.52, 0.84)[26] Pipeline Development - Registrational filings for Sonro in China for R/R CLL and R/R MCL have been submitted[13] - Phase 3 trials have been initiated for Sonro in combination with CD20 antibody[13] - Global registrational filings for Sonro in R/R MCL are expected in the second half of 2025[13]