证券研究报告 | 医药生物 | 2026年1月24日 www.hczq.com | 华创医药团队： | | | --- | --- | | 首席分析师 郑辰 | 执业编号：S0360520110002 邮箱：zhengchen@hcyjs.com | | 联席首席分析师 刘浩 | 执业编号：S0360520120002 邮箱：liuhao@hcyjs.com | | 医疗器械组组长 李婵娟 | 执业编号：S0360520110004 邮箱：lichanjuan@hcyjs.com | | 中药和流通组组长 高初蕾 | 执业编号：S0360524070002 邮箱：gaochulei@hcyjs.com | | 分析师 王宏雨 | 执业编号: S0360523080006 邮箱: wanghongyu@hcyjs.com | | 分析师 朱珂琛 | 执业编号：S0360524070007 邮箱：zhukechen@hcyjs.com | 本报告由华创证券有限责任公司编制 报告仅供单创证券有限责任公司的客户使用，本公司不会因按人找到不报告而视其为客户。 华创证券的这些信息的准确性和完整也不作任何保证。报告中的内容 ...

Summary of Sanofi's Presentation at JP Morgan Healthcare Conference Company Overview - **Company**: Sanofi - **Event**: JP Morgan Healthcare Conference - **Key Speakers**: Paul Hudson (CEO), François-Xavier Roger (CFO), Houman Ashrafian Core Industry Insights - **Growth Rate**: Sanofi reported an 8.7% growth through Q3, with expectations of approaching double-digit growth in the near future, potentially maintaining this for over five years [8][9] - **Blockbuster Products**: The company has launched Altuvio, generating close to $4 billion in revenue, aimed at offsetting potential losses from Dupixent [8] - **R&D Challenges**: Sanofi acknowledged challenges in R&D but emphasized ongoing transformation and modernization efforts [9] Financial Outlook - **Earnings Growth**: The company aims to grow EPS despite the anticipated loss of exclusivity (LOE) for Dupixent [9] - **Diversified Growth Profile**: Growth is expected to be well-diversified, with Dupixent contributing about one-third, existing marketed products another third, and new launches the final third [24] - **Profitability Focus**: Sanofi is committed to profitable growth, with expectations for gross margin increases and disciplined spending [24][25] Pipeline and R&D Developments - **Upcoming Trials**: Significant readouts are expected in immunology, including Amlitelimab and Dupixent data later in the year [10][12] - **Combination Therapies**: Sanofi is exploring combination therapies in asthma and other areas, indicating a strong commitment to rare diseases and oncology [11][12] - **New Mechanisms**: The company is open to adding new mechanisms to its portfolio, including bispecifics and other innovative treatments [46][47] Regulatory and Market Challenges - **U.S. Pricing Policy**: Sanofi is navigating complex U.S. pricing negotiations, with a focus on maintaining manageable impacts on their business [15][16] - **Vaccine Policy**: The company is adapting to changing vaccine policies, particularly regarding Beyfortus and RSV, emphasizing the importance of real-world evidence for market acceptance [20][21][70][71] Product Launches and Market Performance - **Beyfortus**: Lauded as the most successful pediatric vaccination launch, with strong efficacy and quick market acceptance due to its cost-effectiveness for healthcare systems [71][72] - **Dupixent**: Continues to show strong growth, with expectations of maintaining its position as a dominant player in the market [62][63] - **Altuvio**: Positioned to become a blockbuster, offering a unique treatment option for patients with hemophilia [66][68] Strategic Business Development - **M&A Discipline**: Sanofi remains disciplined in business development and M&A, focusing on high-quality programs and maintaining a strong balance sheet [30][31] - **Future Investments**: The company is looking to invest in therapeutic areas and potentially white spaces, with no immediate pressure to act [30] Conclusion Sanofi is positioned for sustained growth through a diversified product pipeline, strategic R&D investments, and a focus on profitability. The company is navigating regulatory challenges while capitalizing on successful product launches and maintaining a disciplined approach to business development.

Financial Data and Key Metrics Changes - Company revenue increased from EUR 33 billion to approximately EUR 45 billion since the CEO's appointment, reflecting significant growth [2] - The workforce reduced from 118,000 in 2019 to around 72,000, indicating a focus on efficiency [2] - Manufacturing sites decreased from over 70 to 38, showcasing a modernization effort [2] - In Q3, the company reported an 8.8% growth in revenue, 9.7% growth in BOI, and 12.4% growth in EPS, with a 10.2% growth excluding buybacks [17][18] Business Line Data and Key Metrics Changes - Dupixent experienced a 26% growth in Q3, demonstrating strong commercial capabilities despite competitive threats [3] - The company is focusing on advancing its R&D pipeline, with several drugs in various stages of development, including Tolebrutinib and Amlitelimab [4][5] Market Data and Key Metrics Changes - The U.S. market is projected to face loss of exclusivity (LOE) in 2031, while Europe is expected to follow in 2033 [3] - The company anticipates significant growth opportunities in specialty care, which is becoming a larger part of its portfolio [17] Company Strategy and Development Direction - The company aims to transition into an R&D-led pharmaceutical entity, having exited the consumer health sector [2] - There is a commitment to enhancing the internal pipeline, with a recognition that the current preclinical and early-stage programs are insufficient compared to peers [5] - The acquisition of Blueprint is seen as a strategic move to support top-line growth through the LOE of Dupixent [4][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to commercialize new drugs effectively, despite challenges in R&D [3][4] - There is a cautious outlook for 2027, primarily due to the anticipated loss of R&D offsets from Regeneron [15][17] - The company is focused on maintaining a leveraged P&L while ensuring efficient operations and continued investment in R&D [19][21] Other Important Information - The company is actively pruning its R&D portfolio to focus on high-value indications, which is expected to enhance overall efficiency [43] - Management highlighted the importance of understanding patient demographics and treatment paradigms in immunology to drive future success [69][70] Q&A Session Summary Question: How does the company plan to navigate the LOE in 2031? - The company has a strategy to launch new medicines and has several patents and ideas in development to mitigate the impact of LOE [3] Question: What is the balance between internal pipeline and M&A? - The company acknowledges a shortfall in high-quality preclinical programs and is looking to enhance its pipeline through both internal development and potential acquisitions [5] Question: How does the company view margin progression? - Management indicated that while there are challenges, they expect to maintain efficiency and drive growth in margins through strategic investments and operational improvements [15][17] Question: What is the outlook for Dupixent amidst new competitors? - Management believes Dupixent will continue to grow due to low current biologic penetration in the market, indicating strong future demand [71] Question: What are the expectations for Tolebrutinib's approval? - The company is optimistic about Tolebrutinib's potential market size and is focused on ensuring a perfect REMS for its launch [92][96]

Financial Data and Key Metrics Changes - Company revenue increased from EUR 33 billion to approximately EUR 45 billion since 2019, indicating significant growth [2] - The workforce reduced from 118,000 in 2019 to around 72,000, reflecting a strategic shift towards modernization [2] - Manufacturing sites decreased from over 70 to 38, showcasing efforts to streamline operations [2] - In Q3, the company reported an 8.8% growth in revenue, 9.7% growth in BOI, and 12.4% growth in EPS, excluding buybacks [16] Business Line Data and Key Metrics Changes - Dupixent sales grew by 26% in Q3, demonstrating strong commercial capabilities despite competitive threats [3] - The company is focusing on advancing its pipeline, with key drugs like Tolebrutinib and Amlitelimab expected to contribute to future growth [4][5] Market Data and Key Metrics Changes - The U.S. market is projected to face LOE in 2031, while Europe is expected to follow in 2033, with the company holding numerous patents to mitigate risks [3] - The company anticipates significant growth opportunities in specialty care, which is becoming a larger part of its portfolio [16] Company Strategy and Development Direction - The company aims to transform into an R&D-led pharmaceutical entity, having exited consumer products to focus on high-quality drug development [2] - There is an emphasis on filling the pipeline with high-quality preclinical and phase one programs, as the current pipeline is considered insufficient [5] - The acquisition of Blueprint is seen as a strategic move to support top-line growth through the upcoming LOE of Dupixent [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to commercialize new drugs effectively, despite challenges in R&D [3][4] - There is a cautious outlook for 2027, primarily due to the anticipated loss of R&D offsets from Regeneron [14] - The company is committed to maintaining R&D investment while ensuring financial efficiency and growth [16][21] Other Important Information - The company is actively pruning its R&D portfolio to focus on high-value indications, which is expected to enhance overall efficiency [40] - Management highlighted the importance of understanding patient populations and market dynamics in immunology to drive future success [57] Q&A Session Summary Question: How does the company plan to navigate the LOE in 2031? - The company has a robust pipeline and numerous patents, with plans to launch new medicines to sustain revenue post-LOE [3] Question: What is the company's strategy regarding internal pipeline versus M&A? - The company acknowledges a shortfall in high-quality preclinical programs and is looking to enhance its pipeline through strategic acquisitions [5] Question: How does the company view margin progression and R&D spending? - Management indicated that while R&D spending is crucial, the focus will be on ensuring that investments yield returns and contribute to overall financial health [21][23] Question: What are the expectations for Dupixent's growth in the face of competition? - Management believes Dupixent will continue to grow, supported by a large untapped patient population and the company's strong commercial execution [68] Question: How does the company assess the potential of Amlitelimab? - Amlitelimab is viewed as a potential blockbuster, with management expressing confidence in its market positioning and efficacy [45][51]

AbCellera Biologics Conference Call Summary Company Overview - **Company**: AbCellera Biologics (NasdaqGS: ABCL) - **Date**: November 13, 2025 - **Key Focus**: Transition from a partnership-focused model to developing its own clinical assets [8][12][14] Core Points and Arguments Transition to Internal Development - AbCellera has shifted from primarily building capabilities through partnerships to developing its own clinical assets, completing this transition in 2025 with two wholly owned assets entering the clinic [12][14] - The company aims to retain more economic value from its assets, moving towards co-development models with partners [7][9][12] Partnership Strategy - AbCellera has worked on over 100 programs with partners, focusing on scientific merit, commercial opportunity, and differentiation when selecting partnership opportunities [18][19] - The company continues to engage with strategic partners like Lilly and AbbVie, leveraging its capabilities to enhance their programs [11][21] Clinical Pipeline - **ABCL635**: An antibody targeting the NK3R for treating hot flashes associated with menopause. The company believes it has a significant commercial opportunity due to the large unmet medical need [35][36] - The preferred administration method is a monthly injectable, which over 50% of surveyed women preferred over daily oral options [44] - The clinical development path is straightforward, with a proof of concept study expected to start in early 2026 [60][62] - **ABCL575**: An OX40 ligand antagonist, positioned to potentially outperform existing treatments by targeting upstream pathways [88][90] - **ABCL688**: Another candidate targeting GPCRs, expected to enter clinical trials mid-next year [102][107] Market Dynamics - The market for non-hormonal treatments for menopause is expanding, with competitors like Astellas and Bayer already establishing a presence. AbCellera aims to enter this market with a differentiated product [68][75][80] - The company estimates a $6 billion addressable market for non-hormonal treatments, with significant unmet needs among women contraindicated for hormone replacement therapy [74][76] Financial Position - AbCellera reported over $500 million in cash and equivalents, with total available liquidity around $700 million, providing sufficient resources for at least the next three years [108][109] Additional Important Insights - The company has received government funding to support clinical trials, which has facilitated the establishment of trial sites in Canada without delays [53][54] - The focus on difficult antibody discovery programs has positioned AbCellera as a leader in the field, with a strong reputation among partners [31][32] - The anticipated readouts for the first clinical assets are expected in 2026, which could significantly impact the company's valuation and market perception [14][12]

Core Viewpoint - Ariel Investments' "Ariel Global Fund" reported a +7.38% return in Q2 2025, underperforming compared to the MSCI ACWI Index (+11.53%) and MSCI ACWI Value Index (+5.84%) [1] Group 1: Fund Performance - The second quarter of 2025 was marked by volatility, with stocks initially falling after the "Liberation Day" tariff announcement and then rebounding due to a pause in tariff implementation [1] - Enthusiasm for AI-themed stocks and strong corporate earnings contributed to new highs in global and U.S. indices [1] Group 2: Sanofi (NASDAQ:SNY) Analysis - Sanofi's stock experienced a one-month return of -7.26% and a 52-week decline of 18.46%, closing at $46.86 with a market capitalization of $114.201 billion on September 16, 2025 [2] - Concerns over potential U.S. tariffs on European pharmaceutical imports and mixed results from Phase 3 trials of Itepekimab negatively impacted Sanofi's performance [3] - Despite challenges, the company’s immunology pipeline is viewed as undervalued, with optimism surrounding the growth of Dupixent and upcoming Phase 3 outcomes for Amlitelimab [3] Group 3: Hedge Fund Interest - Sanofi was held by 24 hedge fund portfolios at the end of Q2 2025, a decrease from 27 in the previous quarter [4] - While Sanofi is recognized for its potential, certain AI stocks are considered to offer greater upside potential with less downside risk [4]

Group 1 - Sanofi is recognized as one of the best low-cost stocks to buy according to analysts, with a maintained Buy rating from Leerink Partners analyst David Risinger [1] - The company faces challenges with Amlitelimab in its Phase 3 trial, as results did not meet the high benchmark set by Dupixent, but there is still potential for Amlitelimab to achieve its primary and secondary endpoints [2] - Amlitelimab's novel mechanism and quarterly dosing convenience may help it stand out in the competitive market, and its safety profile shows a low rate of adverse events, leading to optimism for ongoing and upcoming trials [3] Group 2 - Sanofi is a France-based healthcare company involved in researching, developing, manufacturing, and marketing therapeutic solutions [4]

Core Viewpoint - Sanofi announced that the Phase III COAST 1 study of Amlitelimab for the treatment of atopic dermatitis has met all primary and secondary endpoints [1] Group 1: Drug Information - Amlitelimab is a fully human non-T cell depleting monoclonal antibody targeting OX40L, developed by Sanofi [1] - The drug works by blocking the interaction between the key immune regulatory factor OX40L and its receptor OX40, maintaining the balance between pro-inflammatory T cells and regulatory T cells [1] - Amlitelimab is currently the only OX40L antibody in Phase III development [1] Group 2: Therapeutic Applications - The drug is intended for the treatment of a range of immune and inflammatory diseases, including atopic dermatitis, asthma, and hidradenitis suppurativa [1]

Group 1 - The ADP employment number in the US increased by 54,000 in August, which is below market expectations, leading traders to maintain their interest rate cut bets unchanged [1] - The US stock market opened with mixed results, with the Nasdaq up 0.15%, the S&P 500 up 0.11%, and the Dow Jones down 0.06% [1] Group 2 - Salesforce, a customer relationship management software giant, saw its stock drop over 7% as it expects a slowdown in revenue growth for Q3, which is below expectations [1] - Sanofi's stock fell by 8.6% despite its Amlitelimab treatment for atopic dermatitis meeting all primary and secondary endpoints in Phase III studies, as the results did not meet market expectations [1] - Figma, a UI design software developer, experienced a drop of over 19% after its first earnings report post-IPO fell short of expectations, with guidance only slightly exceeding forecasts [1] - American Eagle, a US apparel retailer, surged over 33% after reporting Q2 results that exceeded expectations and reissuing its full-year guidance [1]

Group 1 - In August, the number of layoffs in the U.S. reached 85,979, the highest for the same period since 2020 [1] - The U.S. ADP employment numbers increased by 54,000 in August, below the market expectation of 65,000 [2] - Initial jobless claims in the U.S. for the week ending August 30 recorded 237,000, the highest since June 2025 [2] Group 2 - Nasdaq plans to modify listing rules for small IPOs and Chinese companies, raising the listing threshold [2] - Nvidia is reportedly planning to launch a new chip, B30A, in the Chinese market, potentially priced at twice that of H20 [2] - Apple is expected to introduce an AI network search tool next year to compete with OpenAI and Perplexity AI [2] Group 3 - Eli Lilly's Olomorasib received breakthrough therapy designation from the FDA for lung cancer treatment [2] - Novo Nordisk is researching the effects of Ozempic on Alzheimer's disease, with results expected this fall [2] - Sanofi's Amlitelimab for atopic dermatitis achieved all primary and secondary endpoints in Phase III trials, but results fell short of market expectations [2] Group 4 - Goldman Sachs and T. Rowe Price have established a strategic partnership to provide innovative public-private investment solutions [2] - Unilever plans to reassess 200 executive positions and will lay off 25% of its workforce [2] - WeRide's Robotaxi GXR has commenced 24-hour fully autonomous commercial operations in Guangzhou Huangpu [2] Group 5 - Seagate's Q2 revenue increased by approximately 9.8% year-over-year to $10.24 billion, with adjusted earnings per share of $2.91, exceeding expectations [2] - American Eagle's Q2 revenue reached $1.28 billion, with net profit increasing by 15% year-over-year to $77.6 million, also surpassing expectations [2]