Regeneron Pharmaceuticals (REGN) FY 2025 Annual General Meeting June 13, 2025 10:30 AM ET Speaker0 Good morning, and welcome to the twenty twenty five Annual Shareholder Meeting of Regeneron Pharmaceuticals. The meeting will begin after the following message. Speaker1 At Regeneron, we've always pursued bold science to drive our purpose, transforming lives through groundbreaking innovation. That principle is just as strong today as it was when the company was founded. Speaker2 We committed to not just treati ...

Core Insights - Regeneron Pharmaceuticals is actively discussing its current positioning in the market, particularly focusing on the EYLEA franchise dynamics and the outlook for Dupixent, along with its late-stage pipeline [3]. Group 1: Company Positioning - The company is emphasizing its strategic focus on the EYLEA franchise and Dupixent, indicating a strong commitment to these key products [3]. - There is a clear intention to enhance execution strategies over the next 12 to 18 months, which suggests a proactive approach to market challenges and opportunities [3]. Group 2: Conference Participation - The conference features key participants from Regeneron, including Christopher R. Fenimore, Executive VP of Finance & CFO, and Ryan Crowe, Senior VP of Investor Relations & Strategic Analysis, highlighting the company's leadership engagement with investors [1]. - The presence of analysts from Goldman Sachs, such as Salveen Jaswal Richter, indicates a significant interest from the investment community in Regeneron's future prospects [1].

Regeneron Pharmaceuticals (REGN) FY Conference Summary Company Overview - **Company**: Regeneron Pharmaceuticals (REGN) - **Date of Conference**: June 09, 2025 - **Key Speakers**: Chris Feinmore (CFO), Ryan Crow (Head of IR and Strategic Analysis) Core Business and Strategy - **EYLEA Franchise Dynamics**: Focus on executing the strategy for EYLEA, Libtayo, and Dupixent, with a strong emphasis on internal R&D capabilities and pipeline development [4][5][7] - **Dupixent Performance**: Leading in all indications except for CSU, with a successful COPD launch underway [6][39] - **Libtayo Growth**: Recently became second in NBRxs, with optimistic data presented for adjuvant CSC [6][7] - **Pipeline Investments**: Approximately 45 assets in the pipeline, with key readouts expected in the second half of the year, including metastatic melanoma and myasthenia gravis data [7][8] Financial and Business Development - **Balance Sheet Flexibility**: Regeneron has a strong balance sheet, allowing for potential business development transactions to supplement the product portfolio [11][12] - **23andMe Acquisition**: Ongoing engagement in the auction process for 23andMe, viewed as a strategic opportunity for identity and validation [13][14] - **Share Buyback Strategy**: Average buyback of $1 billion over the past two quarters, with ongoing evaluation of capital allocation strategies [15][16] Regulatory and Manufacturing Updates - **FDA Applications**: Resubmission of the prefilled syringe application for EYLEA, with a decision expected in late August [24][25] - **Manufacturing Enhancements**: Building a fill-finish facility in New York and entering a partnership with Fuji Diosynth to double U.S. manufacturing capacity [22][23] Market Dynamics and Competitive Landscape - **Policy Environment**: Monitoring the fluid policy situation, including potential impacts from tariffs and drug policies [20][21] - **Co-Pay Assistance Programs**: Innovative matching program for co-pay assistance to support patient access to therapies [30][31] - **Competitive Response**: Actively monitoring competitors like Amgen and Roche, focusing on maintaining market share and accelerating EYLEA HD uptake [32][33] Pipeline Highlights - **Key Pipeline Data**: Anticipated data readouts for EYLEA HD, including enhancements for retinal vein occlusion and every four-week dosing [27][28] - **Dupixent Lifecycle Management**: Ongoing exploration of extended dosing intervals and adjacent type two inflammatory pathways [44][45] - **Melanoma and Lung Cancer Programs**: Confidence in LAG-three data for melanoma, with ongoing studies for lung cancer [56][59] Future Outlook - **Obesity Program**: Focus on fat loss rather than weight loss, with promising phase two data from the triplet program [50][51] - **Upcoming PDUFA Dates**: Lenvosteltenab on July 10 and odranextamab on July 30, with potential for earlier lines of therapy [67][70] - **Broad Pipeline**: Over 45 programs in development, with a focus on innovation across various therapeutic areas [71] Conclusion - Regeneron Pharmaceuticals is strategically positioned with a robust pipeline and strong financial flexibility, focusing on internal R&D and market competitiveness while navigating regulatory challenges and market dynamics. The company is optimistic about upcoming data readouts and potential new product launches.

Core Insights - Dupixent has shown a significant efficacy in treating atopic dermatitis in patients with skin of color, achieving a 75% or greater improvement in overall disease severity in over 76% of treated patients [1][5] - The DISCOVER trial results highlight the importance of understanding chronic diseases in underserved populations, particularly in communities of color [1][2] Group 1: Clinical Trial Results - The DISCOVER Phase 4 trial involved 120 patients with atopic dermatitis and skin of color, with 82% being Black [2][5] - At 24 weeks, 76% of patients achieved a ≥75% improvement in overall disease severity (EASI-75), and 53% reported clinically meaningful improvement in itch [5][7] - Patients experienced a 53% reduction in post-inflammatory hyperpigmentation, with scores decreasing from 5.1 (moderate/marked) to 2.4 (mild) [5][6] Group 2: Safety Profile - The safety results from the DISCOVER trial were consistent with Dupixent's known safety profile, with an overall adverse event rate of 42% [3] - Common adverse events included headache (3%), upper respiratory tract infection (2%), and conjunctivitis (3%) [3] Group 3: Disease Characteristics - Atopic dermatitis presents differently in patients with skin of color, often leading to misdiagnosis or underestimation of disease severity [4] - Patients with darker skin tones are more likely to experience severe skin dryness, dyspigmentation, and hardened skin lesions compared to those with lighter skin [4] Group 4: Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways, addressing type 2 inflammation [8] - It has received regulatory approvals in over 60 countries for various indications, including atopic dermatitis and asthma, with over 1 million patients treated globally [9][11]

Group 1 - Hansoh Pharmaceutical granted Regeneron Pharmaceuticals exclusive overseas licensing for its GLP-1/GIP dual receptor agonist HS-20094, which has completed multiple Phase II clinical trials and is currently in Phase III trials in China [1][2] - The licensing agreement includes an upfront payment of $80 million, potential milestone payments of up to $1.93 billion, and double-digit royalties on future sales [2][3] - Recent licensing deals by Chinese pharmaceutical companies indicate a growing trend, with 33 license-out transactions completed in Q1 2025, totaling $36.633 billion, a year-on-year increase of approximately 258% [1][6] Group 2 - The licensing deal with Pfizer for the PD-1/VEGF dual antibody SSGJ-707 includes a record upfront payment of $1.25 billion, with potential milestone payments reaching $4.8 billion [3] - Other companies, such as Sinovant and Ansai, have also announced licensing agreements, indicating a robust market for Chinese pharmaceutical innovations [3][4] - The 2025 ASCO annual meeting showcased over 70 original research results from China, highlighting the international competitiveness of Chinese innovative drugs [4][5] Group 3 - The overall trend shows that Chinese innovative drugs are gaining global value, with a significant increase in licensing transactions and amounts [6][7] - The pharmaceutical industry is expected to see steady recovery, driven by the growing demand for innovative therapies and the improvement in the quality and quantity of domestic innovative drugs [7]

Core Insights - Regeneron Pharmaceuticals (REGN) has been in a downtrend for over 280 days, currently in the 10th Phase of its 18-Phase Adhishthana Cycle, indicating a significant structural breakdown rather than mere technical fluctuations [1][15]. Historical Performance - The current Adhishthana Cycle for Regeneron began on January 29, 2018, with the stock initially following expected market behaviors until Phase 9 [2]. - In Phase 2, Regeneron experienced a strong Rally of Buddhi, surging approximately 113% after a consolidation period of 37 bars [5]. - Phase 3 saw a slight rally followed by a rounded top, leading to a decline of about 33%, aligning with the Adhishthana framework [8]. - Phase 6 established a Nirvana Level at $671.41, which now serves as a valuation benchmark [10]. Phase 9 Breakdown - Phase 9 typically marks a breakout above the bullish "Cakra" channel, but Regeneron broke downwards, leading to a significant decline [13]. - This breakdown triggered the Move of Pralaya, resulting in a collapse of bullish sentiment and a stock price drop of approximately 54% since the break [14]. Future Outlook - Currently in Phase 10, Regeneron is in a state of structural limbo, with no meaningful recovery expected until it enters the Guna Triads (Phases 14, 15, and 16), which begin on February 7, 2028 [15]. - The current structure suggests continued weakness and uncertainty for the stock until the completion of the Guna Triads [15].

目前，HS-20094 正在中国进行 III 期临床试验，国内肥胖症的 3 期试验和糖尿病的 2b 期研究也在同步推进。若后续试验顺利完成，HS-20094 有望为全球众 多糖尿病及肥胖症患者带来全新的治疗选择。 根据协议，翰森制药将获得8000万美元首付款，并有资格根据该产品开发、注册审批和商业化进展收取最高19.3亿美元里程碑付款，以及未来潜在产品销售 的双位数百分比特许权使用费。（总包超20亿美元：8000万美元首付款＋19.3亿美元里程碑＋潜在销售双位数百分比）。 HS-20094：潜力巨大的在研药物 HS-20094是一款在研GLP-1/GIP双受体激动剂，已在多项 II 期临床试验中崭露头角，展现出积极的疗效和安全性数据。 它通过选择性激活 GLP-1 受体和 GIP 受体，能够促进胰岛素分泌，延缓胃排空，并抑制食欲减少进食量，进而产生控糖、减重及代谢改善等一系列生物学 效应。其给药方式为每周一次皮下注射，极大地方便了患者使用。 | HS-20094 | | | | --- | --- | --- | | | HS-20094 | | | 药品名称 | 研发代码:HS-20094 | | | | ...

整理 | GLP1减重宝典内容团队 再生元制药公司（NASDAQ: REGN）宣布与翰森制药集团有限公司（"翰森制药"）达成许可协议，再生元获得GLP-1/GIP双重受体激动剂 （HS-20094）在中国大陆、香港和澳门以外地区的独家临床开发和商业化权利。 该候选药物目前正处于三期临床试验阶段，作为每周一次的皮下注射方案，已在超过1,000名患者中进行测试，显示出良好的安全性和疗效，其 表现与目前美国FDA唯一批准的GLP-1/GIP双重受体激动剂相似。目前，该药正在中国进行一项治疗肥胖的三期临床试验以及一项糖尿病二期b 试验。 根据协议条款，再生元将向翰森制药支付8000万美元的预付款，并在开发、监管及销售里程碑达成时，可能额外支付最高19.3亿美元。此外，在 协议指定地区以外的全球销售收入中，翰森制药还将获得低双位数百分比的销售提成。 再生元内科临床开发高级副总裁Boaz Hirshberg医学博士补充道："获得这一处于后期开发阶段的药物，使我们有机会将其与自有在研药物进行 联合探索，进一步解决肌肉流失以及心血管疾病、肝脏疾病和糖尿病等肥胖并发症。这也与我们在肥胖治疗领域的整体战略相一致，例如我们正 在进 ...

Core Insights - The market is anticipating significant business development (BD) transactions at the upcoming ADA (American Diabetes Association) conference in late June 2025, particularly in the obesity treatment sector [9][11] - Regeneron and Hansoh Pharmaceutical have announced a major licensing deal for Hansoh's GLP-1/GIP dual receptor agonist HS-20094, indicating a strategic shift towards high-quality weight loss solutions [1][2] Group 1: Company Developments - Regeneron has committed to enhancing obesity treatment quality, focusing on sustainable weight loss and muscle preservation, as highlighted by their management during the Q1 2025 earnings call [2][3] - The licensing agreement for HS-20094 includes an upfront payment of $80 million and potential milestone payments totaling up to $1.93 billion, emphasizing the financial stakes involved in this partnership [1] - HS-20094 has shown promising results in Phase II trials, demonstrating significant weight loss comparable to existing treatments while currently undergoing Phase III and Phase IIb trials in China [1][3] Group 2: Industry Trends - The obesity treatment industry is transitioning from a focus on mere weight loss to a more nuanced approach that emphasizes fat loss without muscle loss, termed "weight loss 2.0" [4][5] - There is a growing emphasis on developing "muscle-friendly" weight loss drugs that not only reduce fat but also preserve or enhance muscle mass, addressing a significant unmet need in the market [4][6] - Multiple pharmaceutical companies are exploring various pathways to achieve muscle preservation during weight loss, with several candidates currently in development [5][7] Group 3: Future Outlook - The ADA 2025 conference is expected to showcase important research findings in weight management, potentially catalyzing further collaborations and transactions in the industry [9][10] - The trend of "conference-driven transactions" is anticipated to continue, with the ADA conference serving as a pivotal moment for innovation in obesity treatments [10][11] - The expansion of high-quality weight loss medications could broaden the market's reach, appealing to diverse patient populations, including the elderly and those with sarcopenic obesity [8][7]

Core Viewpoint - Regeneron Pharmaceuticals' stock has experienced a significant decline due to the failure of its COPD treatment, itepekimab, in a late-stage clinical trial, which was expected to be a blockbuster drug with peak sales projections between $2 billion and $6 billion [1][14]. Stock Performance - Regeneron shares fell 19% on May 30, trading at $490, which is a 60% decrease from its 52-week peak of approximately $1,200 [2]. - The stock has seen a notable drop of 25.8% from a peak of $738.84 on April 8, 2022, to $548.35 on June 14, 2022, compared to a 25.4% decline for the S&P 500 [13]. Financial Metrics - Regeneron has a price-to-sales (P/S) ratio of 4.6, a price-to-free cash flow (P/FCF) ratio of 16.4, and a price-to-earnings (P/E) ratio of 14.4, compared to 3.0, 20.5, and 26.4 for the S&P 500, respectively [8]. - The company's revenues have grown 7.5% from $13 billion to $14 billion in the past 12 months, while the S&P 500 saw a 5.5% growth [8]. - Regeneron's operating income over the last four quarters was $3.8 billion, with an operating margin of 27.2%, significantly higher than the S&P 500's 13.2% [12]. Profitability and Stability - Regeneron has demonstrated very strong profitability, with a net income margin of 31.9% compared to 11.6% for the S&P 500 [12]. - The company's balance sheet is robust, with a debt total of $2.7 billion and a market capitalization of $52 billion, resulting in a low debt-to-equity ratio of 4.2% [12]. Future Growth Potential - Despite the setback with itepekimab, Regeneron is expected to benefit from the strong growth of Dupixent, which saw sales rise 19% to $3.7 billion last quarter, with potential peak annual sales exceeding $20 billion [14]. - The company has a promising pipeline with over a dozen programs in late-stage trials, indicating future growth opportunities [14].