抗凝药物升级窗口已至，下一代药物箭在弦上 国泰海通发布研报称，人口老龄化与心血管疾病患病率攀升推动抗血栓药物市场持续扩容，其中抗凝药 物作为核心品类，市场需求稳步增长，中国市场增速尤为显著，为新型抗凝药物研发与商业化奠定了广 阔的市场基础。凭借"精准抗凝、低出血风险"的独特优势，FXI成为下一代抗凝药的理想靶点，目前全 球有多款FXI/FXIa抑制剂进入注册性临床阶段，涵盖小分子、大分子单抗、siRNA等多种技术路线，覆 盖房颤、卒中预防、静脉血栓栓塞等多个适应症。 国泰海通主要观点如下： 抗血栓药物市场需求扩容，格局待新 血栓性疾病成为全球主要死亡原因之一，人口老龄化与心血管疾病患病率攀升推动抗血栓药物市场持续 扩容，2023年全球市场规模已达529亿美元，预计2033年将突破1100亿美元。其中抗凝药物作为核心品 类，市场需求稳步增长，中国市场增速尤为显著，为新型抗凝药物研发与商业化奠定了广阔的市场基 础。 2)大分子FXI单抗中，诺华的Abelacimab已获得FDA两项快速通道资格，分别针对房颤卒中预防及肿瘤 相关血栓，目前正在推进III期临床；再生元双管线布局FXI单抗，直接阻断FXI的催化结构域的 ...

从靶点到管线，FXI 引领抗凝产业新变革 [Table_Industry] 医药 FXI/FXIa 抑制剂行业研究报告 | [Table_Invest] | | | --- | --- | | 评级： | 增持 | | | | | [姓名table_Authors] | 电话 | 邮箱 | 登记编号 | | --- | --- | --- | --- | | 彭娉(分析师) | 021-23185619 | pengping@gtht.com | S0880525040080 | | 余文心(分析师) | 021-38676666 | yuwenxin@gtht.com | S0880525040111 | 本报告导读： 靶向 FXI 的药物可在不显著增加出血风险的前提下防治血栓，有望为患者提供更安 全的抗凝选择。当前该领域的研发活跃，2026 年起预计有多个药物进入关键数据读 出的阶段，静待抗凝领域新一代"大药"的诞生。 投资要点： [Table_Report] 相关报告 医药《医疗设备招采规模高基数影响部分回落， 关注手术机器人市场机遇》2026.02.09 医药《高景气延续，持续推荐创新药械产业链》 2 ...

Financial Data and Key Metrics Changes - In Q4 2025, total revenue was approximately $12.5 billion, flat year-over-year, while the growth portfolio revenue increased by 15% to $7.4 billion, representing nearly 60% of total revenue [14][15] - For the full year, the growth portfolio grew 17%, offsetting a decline of roughly $4 billion in revenue from the legacy portfolio [6][7] - Adjusted diluted earnings per share for Q4 were $1.26, and for the full year, it was $6.15, both including a net charge related to in-process R&D and licensing income [20] Business Line Data and Key Metrics Changes - Opdivo revenue grew 7% to nearly $2.7 billion in Q4, driven by new indications and share growth in first-line non-small cell lung cancer [15] - Reblozyl achieved 21% growth, reflecting solid uptake across MDS-associated anemia patients [16] - Breyanzi's revenue increased by 47% in Q4, driven by strong demand across its approved indications [16] - Eliquis revenue was nearly $3.5 billion in Q4, up 6%, supported by demand growth and market share gains [16] Market Data and Key Metrics Changes - The U.S. market for Eliquis saw a 4% revenue increase, contributing to its overall growth [16] - Camzyos revenue grew 57% to $353 million in Q4, benefiting from global demand growth [17] - Sotyktu's global revenue grew 3%, with upcoming PDUFA dates for psoriatic arthritis and phase III readouts for lupus and Sjögren's disease [17] Company Strategy and Development Direction - The company aims to deliver industry-leading sustainable growth into the 2030s, focusing on executing its growth strategy and advancing its pipeline [11][23] - A multi-year plan is in place to rewire the company for long-term growth, with expectations to introduce over 10 new medicines and 30 meaningful launch opportunities by 2030 [9][10] - The company is expanding the use of AI to enhance operational efficiency and reinvest strategically in growth [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth portfolio's ability to drive revenue despite anticipated declines in the legacy portfolio due to ongoing LOE impacts [12] - The company expects 2026 revenue in the range of $46-$47.5 billion, with a projected decline of 12%-16% in the legacy portfolio [12][21] - Management highlighted the importance of maintaining a strong say-to-do ratio and delivering on commitments as part of the company culture [11] Other Important Information - The company completed a targeted $10 billion debt paydown ahead of schedule and generated strong cash flow from operations of approximately $2 billion in Q4 [20] - The effective tax rate for Q4 was 22.1%, reflecting a one-time non-tax deductible in-process R&D charge related to the Orbital acquisition [19] Q&A Session Summary Question: Insights on pivotal catalysts for 2026 - Management highlighted the potential for over 10 phase III data readouts this year, with a focus on products like Milvexian and Admilparant [25][28] Question: Eliquis dynamics for 2026 - Eliquis is expected to grow 10%-15% in 2026, driven by market share gains and pricing strategy adjustments [39] Question: Business development priorities - The company is focused on deepening its presence in existing therapeutic areas while remaining opportunistic for new opportunities [37] Question: Milvexian AFib study updates - The study is progressing well, with a focus on demonstrating non-inferiority to Eliquis and potential benefits in bleeding risks [46] Question: Admilparant's hypotension risk - Management indicated that the hypotension risk is being well managed in the phase three studies, with a focus on higher dosing [89]

Financial Data and Key Metrics Changes - In Q4 2025, worldwide sales reached $24.6 billion, a 7.1% increase despite a 650 basis point headwind from Stelara [17] - For the full year 2025, worldwide sales were $94.2 billion, reflecting a 5.3% increase, with U.S. growth at 6.9% and international growth at 3.4% [18] - Net earnings for Q4 were $5.1 billion, with diluted earnings per share at $2.10, compared to $1.41 a year ago [18] - Full year 2025 net earnings were $26.8 billion, with diluted earnings per share at $11.03, significantly up from $5.79 the previous year [19] Business Line Data and Key Metrics Changes - Innovative Medicine reported Q4 sales of $15.8 billion, a 7.9% increase, with notable growth in oncology and immunology [20] - In oncology, Darzalex grew 24.1%, while Carvykti achieved sales of $555 million with a growth of 63.2% [20] - Immunology saw Tremfya grow 65.4%, while Stelara declined 48.6% due to biosimilar competition [21] - MedTech sales for the year were $34 billion, with operational growth of 5.4%, driven by cardiovascular and surgical segments [13] Market Data and Key Metrics Changes - U.S. sales growth was 7.5% in Q4, while international sales grew by 6.6% [17] - The cardiovascular segment delivered 15% operational sales growth, with Abiomed and Shockwave showing strong performance [13] - Surgical vision grew 10.8%, driven by new product innovations and demand for premium intraocular lenses [24] Company Strategy and Development Direction - The company plans to separate its orthopedics business by mid-2027, focusing on high-growth areas [30] - Investments of over $32 billion in R&D and M&A were made in 2025, including acquisitions of Intra-Cellular Therapies and HALDA Therapeutics [6] - The company aims for double-digit growth by the end of the decade, supported by a strong portfolio and pipeline [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving faster growth in 2026 compared to 2025, with a line of sight to double-digit growth [6] - The company anticipates operational sales growth in 2026 to be between 5.7% and 6.7%, with a midpoint of $100 billion [31] - Management highlighted the strength of their portfolio and pipeline as key drivers for future growth [41] Other Important Information - The company ended 2025 with approximately $20 billion in cash and marketable securities, and $48 billion in debt [30] - A net interest expense of $300 million to $400 million is expected for 2026 [33] - The effective tax rate is projected to be between 17.5% and 18.5% for 2026 [34] Q&A Session Summary Question: Overview of growth prospects and key levers for double-digit growth - Management highlighted the strength of the portfolio and pipeline, focusing on oncology, immunology, and MedTech as key growth areas [40][41] Question: MedTech market dynamics and growth expectations - Management does not expect the loss of ACA subsidies to materially impact MedTech performance, with a focus on clinical capacity driving growth [48] Question: Margin progression and relationship to top-line growth - Management indicated that margin improvements will align with sales growth, with expectations for at least 50 basis points of improvement in 2026 [55] Question: Vision care market health and performance - Management noted strong underlying demand in the contact lens category, with robust growth driven by new product launches [58][59]

Summary of Bristol-Myers Squibb Company (NYSE:BMY) FY Conference Call Company Overview - **Company**: Bristol-Myers Squibb Company (BMY) - **Event**: 44th Annual JPMorgan Healthcare Conference - **Date**: January 12, 2026 Core Industry Insights - **Focus**: The company aims to build a financially strong organization capable of delivering sustainable growth into the 2030s and beyond [2][16] - **Growth Portfolio**: Increased by 17% in the first nine months of 2025, with four products each generating over $1 billion in annual sales [3][2] - **Key Products**: - Opdualag (melanoma) - Breyanzi (CAR-T therapy for lymphoma) - Camzyos (treatment for obstructive HCM) - Reblozyl (annualizing over $2 billion in sales) [3][2] Financial Performance - **Debt Management**: Achieved a $10 billion debt paydown ahead of schedule, resulting in a stronger balance sheet [5][4] - **Cost Optimization**: On track to deliver $2 billion in cost savings, enhancing financial discipline [4][18] - **Shareholder Returns**: Returned over $22 billion to shareholders in the last three years and increased dividends for 17 consecutive years [15][16] Pipeline and R&D Developments - **Pipeline Progress**: Significant advancements in the pipeline with multiple late-stage assets expected to deliver value [5][11] - **Key Late-Stage Assets**: - **Cobenfy**: Approved for schizophrenia; pivotal studies in Alzheimer's disease psychosis expected to read out this year [6][11] - **Milvexian**: A Factor XIa inhibitor with potential in atrial fibrillation and secondary stroke prevention; phase III results anticipated [6][11] - **Admilparant**: Targeting pulmonary fibrosis with phase III results expected [7][11] - **Iberdomide and Mezigdomide**: Oral CELMoDs in multiple myeloma, with promising data leading into phase III trials [9][11] Strategic Focus Areas - **Business Development**: Completed $30 billion in deals over the past 24 months, with a focus on enhancing the growth profile [16][26] - **Execution and R&D**: Emphasis on improving execution across the organization, leveraging AI and machine learning to enhance R&D efficiency [13][30] - **Therapeutic Areas**: Continued focus on building depth in core therapeutic areas while exploring opportunities in adjacent markets [27][28] Market Position and Competitive Landscape - **Confidence in Product Portfolio**: Strong confidence in the existing product portfolio, with Eliquis continuing to perform well despite patent expirations [21][22] - **Diversified Pipeline**: The company has a diversified set of assets, reducing reliance on any single product for growth [23][24] - **Regulatory Engagement**: Positive engagement with the administration regarding Medicaid and pricing strategies, aiming to simplify the healthcare ecosystem [49][50] Conclusion - **Outlook for 2026**: The company is positioned for a busy year with multiple data readouts and product launches expected, focusing on commercial execution and maintaining financial discipline [47][48] - **Long-Term Vision**: Aiming for sustained growth through a diversified portfolio and strategic investments in R&D and business development [12][16]

Financial Data and Key Metrics Changes - The company reported a strong year in 2025, with over 50% of the business transitioning to a growth portfolio that grew by 18% in the most recent quarter [23] - The growth portfolio now includes four products that are annualizing over $1 billion, with Reblozyl annualizing over $2 billion [23][24] - The company achieved a reduction in its expense base from $17.8 billion last year to $16.5 billion this year, with a target of an additional $1 billion in savings for 2026 and 2027 [26][27] Business Line Data and Key Metrics Changes - Cobenfy, a product for schizophrenia, has surpassed 2,700 TRXs weekly and is approaching 3,000 TRXs, significantly exceeding other recent schizophrenia launches [10][11] - Camzyos is annualizing over $1 billion, with expectations for continued significant growth as awareness and diagnosis rates improve [76] - The company is focusing on expanding its pipeline with multiple studies in areas such as Alzheimer's disease, bipolar disorder, and autism irritability [17][21] Market Data and Key Metrics Changes - The company has established a strong access position in Medicaid, Medicare, and commercial settings for Cobenfy, which is critical given the dominance of government payers in this space [10] - The launch of Cuvantic has seen a strong conversion from IV to subcutaneous administration, with expectations that 30%-40% of the IV business will convert by 2028 [44] Company Strategy and Development Direction - The company aims to continue driving its growth portfolio and executing against its pipeline, with a focus on operational efficiencies and cash flow generation [25][27] - The company is leveraging AI to enhance efficiency in drug development and manufacturing processes, which is expected to drive shareholder value [29][30] - The company is actively seeking partnerships and acquisitions in therapeutic areas with high unmet needs, particularly in immunology and oncology [39][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory and operational efficiencies, with a strong cash position of $17 billion at the end of Q3 [28] - The company is optimistic about upcoming data readouts and the potential for new product launches, particularly in the areas of atrial fibrillation and Alzheimer's disease [66][70] Other Important Information - The company is engaging with policymakers on tariff and healthcare policy issues, emphasizing the importance of access to medicines and the normalization of cost differentials [94][95] - The company has implemented direct-to-patient initiatives, significantly reducing costs for patients, which aligns with broader industry trends [97][98] Q&A Session Summary Question: Can you discuss the recent developments in the COVID study? - The company announced that the ADEPT 2 study will continue with additional patient enrollment after addressing irregularities found during clinical trial site reviews [5][6] Question: What is the current status of Cobenfy in the market? - Cobenfy has achieved strong access in Medicaid, Medicare, and commercial settings, with TRXs approaching 3,000 weekly, indicating significant market traction [10][11] Question: How is the company leveraging AI for efficiencies? - AI is being used to enhance drug development processes, improve manufacturing efficiency, and streamline internal operations, which is expected to drive shareholder value [29][30] Question: What are the company's plans for future product development? - The company has multiple studies underway in various therapeutic areas, including Alzheimer's disease and bipolar disorder, and is confident in the potential for positive outcomes [17][21] Question: How is the company addressing the competitive landscape in oncology? - The company is focusing on partnerships and acquisitions in areas with high unmet needs, particularly in immunology and oncology, to strengthen its market position [39][40]

Financial Data and Key Metrics Changes - The company reported a strong year in 2025, with the growth portfolio now comprising over 50% of the business and growing at 18% [30] - The growth portfolio includes four products annualizing over $1 billion, with Reblozyl exceeding $2 billion [31] - The company achieved a reduction in expense base from $17.8 billion last year to $16.5 billion this year, with an additional $1 billion in savings expected for 2026 and 2027 [33] Business Line Data and Key Metrics Changes - Cobenfy has surpassed 2,700 TRXs weekly, approaching 3,000 TRXs, significantly exceeding other recent schizophrenia launches [12] - Camzyos is annualizing over $1 billion, with expectations for continued significant growth as awareness and diagnosis rates improve [87] - The Cuvantic launch has seen strong conversion from IV to subcutaneous administration, with expectations of 30%-40% conversion of IV business by 2028 [51] Market Data and Key Metrics Changes - The company has a strong access position in Medicaid, Medicare, and commercial settings, which is critical in the schizophrenia market [12] - The company is seeing broad utility across various tumor types for Cuvantic, indicating a strong market presence [50] - The company is actively pursuing opportunities in China, recognizing the increasing percentage of INDs coming from that region [75] Company Strategy and Development Direction - The focus for 2026 is to continue driving the growth portfolio and executing against the pipeline, with a strong emphasis on operational efficiencies [32] - The company is leveraging AI to enhance drug development processes and improve operational efficiencies [35] - The company is committed to exploring high unmet needs in therapeutic areas where they have scientific expertise and commercial acumen [42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ADEPT program and the broader Cobenfy development program, projecting positive outcomes from ongoing studies [7] - The company is optimistic about the upcoming phase 3 data readouts and the potential for new NMEs by the end of the decade [32] - Management highlighted the importance of direct-to-patient initiatives to improve access and affordability of medications [114] Other Important Information - The company is actively engaging with policymakers regarding tariffs and supply chain flexibility, emphasizing the importance of access to medicines [108] - The company has made significant investments in AI to enhance efficiency in drug development and manufacturing processes [35] - The company is exploring partnerships and acquisitions in areas with high unmet medical needs, particularly in immunology and oncology [45] Q&A Session Summary Question: What is the outlook for the ADEPT studies? - Management is confident in the ADEPT program and has already initiated studies in various indications, including Alzheimer's and bipolar disorder [22][24] Question: How is the company leveraging AI for efficiencies? - AI is being used to accelerate drug development, improve site selection, and enhance manufacturing processes, driving overall efficiency [35][36] Question: What is the strategy for capital deployment moving forward? - The company will continue to focus on high unmet needs within existing therapeutic areas while also exploring new opportunities for partnerships and acquisitions [42][45] Question: How is the Cuvantic launch performing? - The Cuvantic launch has seen strong conversion rates and broad utility across multiple tumor types, with expectations for continued growth [50][51] Question: What are the expectations for Camzyos? - Camzyos is expected to see significant growth as awareness and diagnosis rates improve, with a focus on expanding its use in community cardiology [87][90]

Core Viewpoint - Bristol Myers Squibb (BMY) is expanding patient enrollment in the ADEPT-2 Phase 3 study for Cobenfy, a drug aimed at treating psychosis associated with Alzheimer's disease dementia, following a recommendation from the Data Monitoring Committee (DMC) after an interim analysis [1][6]. Study Details - The ADEPT-2 study is a multicenter, randomized, double-blind, placebo-controlled trial focused on assessing the safety and efficacy of Cobenfy in patients with Alzheimer's-related psychosis [2]. - The primary endpoint of the study is the change in the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score, while the key secondary endpoint is the Clinical Global Impression-Severity (CGI-S) [3]. Clinical Trial Adjustments - Irregularities were identified in the clinical trial execution at a few study sites, leading the company to exclude data from these sites from the primary analysis after consulting with the FDA [4][5]. - The DMC recommended continuing the study with additional patient enrollment, and Bristol Myers will proceed as advised while remaining blinded to the study data [6]. Market Reaction and Analyst Insights - Analysts view the ADEPT-2 study as crucial due to the significant market opportunity and the need for positive momentum following recent setbacks in other late-stage programs [7]. - The backing from the DMC and FDA for continued enrollment is seen as a potentially positive signal, especially given the pressure on Bristol Myers shares [7][8]. - Additional results from the ADEPT program, including ADEPT-1 and ADEPT-4, are expected to be released by the end of 2026, which is later than previously anticipated [8]. Stock Performance - Bristol Myers Squibb shares experienced a 5.77% increase, reaching $51.03 at the time of publication [10].

Regeneron Pharmaceuticals Conference Call Summary Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Event**: 2025 Conference on November 17, 2025 Key Industry Insights - **Eylea Performance**: - High-dose Eylea (Eylea HD) has shown significant growth with demand increasing by 5% in Q1, 16% in Q2, and 18% in Q3 [4][5][6] - Anticipated growth for Q4 is expected to moderate to high single digits due to competitive market pressures [5] - The competitive landscape includes pricing pressures, with an 8% price impact noted in Q3 [9] - **Market Dynamics**: - Regeneron is focused on differentiating Eylea through real-world efficacy and durability, which is resonating with physicians [4] - The company is addressing reimbursement confidence among physicians to ensure continued prescribing of Eylea HD [5][6] - **Patient Assistance Programs**: - Regeneron has instituted a matching program to support patient assistance organizations, aiming to match contributions up to $200 million, but has seen disappointing participation [12][13] - Concerns exist regarding the impact of patients not receiving supplemental insurance, with an expected 10% impact on patient access [11] Product Development and Regulatory Updates - **Label Enhancements**: - Regeneron is working on label enhancements for Eylea HD, with a PDUFA date later this month for RVO and Q4 dosing [18][19] - The company is optimistic about potential approvals by year-end, contingent on successful inspections of alternative fillers [19][20] - **Pipeline and Future Opportunities**: - Regeneron is exploring opportunities in obesity treatments, including the Hanmi GLP-1 asset, which could be a significant player in the market [31][32] - The company is also investigating Myostatin and its potential applications in obesity and related comorbidities [35][37] Financial Strategy and Shareholder Value - **Capital Deployment**: - Regeneron emphasizes investing in internal capabilities and expanding manufacturing, with a $2 billion investment in New York State [26][27] - The company has a share repurchase program and initiated a dividend program earlier this year [27] - **Cash Management**: - Regeneron is focused on deploying cash effectively to enhance shareholder value, with a cautious approach to accumulating excessive cash reserves [30] Conclusion - Regeneron Pharmaceuticals is navigating a competitive landscape with Eylea while focusing on patient access and assistance programs. The company is actively pursuing label enhancements and exploring new market opportunities in obesity treatments. Financially, Regeneron is committed to strategic investments and maintaining shareholder value through capital deployment and cash management strategies.

Core Viewpoint - Sirius Therapeutics has submitted its listing application to the Hong Kong Stock Exchange, with a valuation of approximately $253 million after its Series B funding round in April 2025, backed by prominent investors [1][2]. Group 1: Company Overview - Sirius Therapeutics was established in 2021 and focuses on developing siRNA therapies [1]. - The company is co-founded by top healthcare investment firms OrbiMed Entities and Creacion Ventures, holding over 40% of shares, with Tencent's investment arm holding 8.14% and Hancan Capital holding over 13% [1]. - The company reported a net loss of 309 million yuan and 342 million yuan for 2023 and 2024, respectively, totaling 651 million yuan in losses [3]. Group 2: Financial Performance - In the first half of 2025, Sirius Therapeutics achieved a net profit of 34.46 million yuan, marking its first profitable period, primarily driven by non-recurring income [3][4]. - The company generated 144 million yuan in other income, a significant increase from 4.51 million yuan in the same period last year, largely due to a strategic partnership with CRISPR Therapeutics [3][4]. Group 3: Product Pipeline and Challenges - The core product, SRSD107, is in Phase II clinical trials for venous thromboembolism, while two key products, SRSD216 and SRSD384, are also in various stages of development [5][6]. - The company faces significant competition in the FXI/FXIa inhibitor space, with several competitors already in Phase III trials, including drugs from Novartis, Bayer, and Johnson & Johnson [7][8]. - Sirius Therapeutics has 65 patents and applications, but only one has been granted, with 32 critical patents pending, posing potential risks in a competitive biopharmaceutical landscape [9].