Company Overview - Regeneron Pharmaceuticals, Inc. is participating in the BofA Securities 2025 Healthcare Conference, with key speakers including Marion McCourt, Executive Vice President of Commercial, and Ryan Crowe, Senior Vice President of Investor Relations and Strategic Analysis [1][2]. Financial Performance - The company reported challenges in the retina space but showed strength across its overall commercial portfolio in the first quarter results released two weeks prior to the conference [4]. Product Insights - EYLEA and EYLEA HD are experiencing typical seasonality headwinds associated with the first quarter, along with significant impacts from inventory for EYLEA two milligram [5].

Summary of Regeneron Conference Call Company Overview - **Company**: Regeneron Pharmaceuticals - **Key Speakers**: - Marianne McCourt, Executive Vice President of Commercial - Ryan Crow, Senior Vice President, Investor Relations and Strategic Analysis Industry Context - **Industry**: Biopharmaceuticals - **Key Products**: EYLEA, DUPIXENT, Libtayo Core Points and Arguments Financial Performance - **EYLEA**: Experienced challenges in the retina space, with Q1 sales impacted by seasonality and inventory issues. Sales dropped from $6 billion last year to an expected $4 billion this year due to biosimilar competition [3][29]. - **DUPIXENT**: Grew 19% globally, leading in prescription share across approved indications, except for Chronic Spontaneous Urticaria (CSU) which was recently approved [3][50]. - **Libtayo**: Grew 21% in the US, now second in new to brand share in advanced lung cancer [4]. Pipeline Developments - Upcoming pivotal readouts include: - Itapakimab for COPD in former smokers [4]. - Combination of LAG-three antibody fianlimab with Libtayo for advanced melanoma [5]. - Pivotal readout for semdisiran in generalized myasthenia gravis [5]. - PDUFA dates for limboceltimab and rotranextamab in July [5]. Capital Allocation - Regeneron is investing approximately $7 billion in R&D and manufacturing capabilities in the US. A dividend program was initiated to return capital to shareholders alongside a buyback program [6]. Regulatory Environment - The company is assessing the impact of the Most Favored Nation (MFN) executive order and potential tariffs on its operations. Regeneron aims to engage with the administration to navigate these changes [8][9]. - The company emphasizes the importance of innovation and patient access to medicines amidst regulatory changes [13][14]. Mergers and Acquisitions (M&A) - Regeneron does not plan to change its conservative approach to M&A, focusing on organic growth and partnerships rather than transformative acquisitions [11][12]. EYLEA Challenges - EYLEA faces competition from biosimilars and affordability issues, leading to increased prescribing of Avastin. Despite a disappointing Q1, EYLEA HD showed a 5% increase in demand [31][32]. - The upcoming approval of a prefilled syringe and new indications are expected to enhance EYLEA's market position [33]. DUPIXENT Launch and Market Dynamics - DUPIXENT is performing well with strong uptake in COPD, achieving 85-90% payer access. The product is expected to reach $20 billion in sales by 2030 [50][52]. - The company is optimistic about the upcoming itapacumab product, which targets a different COPD patient population [53][55]. Competitive Landscape - Regeneron acknowledges competition in the atopic dermatitis market, particularly from Lilly's new product, but maintains confidence in DUPIXENT's established position [61][62]. Additional Important Insights - The company is adapting its copay assistance strategy, moving towards a matching donation model to support patient access [45][46]. - Regeneron is focused on maintaining its commitment to innovation while navigating the complexities of the US healthcare system [14][22]. This summary encapsulates the key points discussed during the Regeneron conference call, highlighting the company's current performance, pipeline developments, regulatory challenges, and strategic direction.

Industry Overview - The bear market caused by the Federal Reserve's monetary tightening ended in 2023, but the biotech sector continues to lag behind the broader market, with the SDPR S&P Biotech ETF trading at levels similar to 2017 [1] - Despite the skepticism surrounding biotech stocks post-COVID-19 pandemic, there are signs of potential recovery in 2025, driven by companies making progress on new drugs and innovative therapies [2] Company Highlights Vertex Pharmaceuticals - Vertex Pharmaceuticals has been a leader in developing cystic fibrosis treatments, including Kalydeco and Trikafta, and has recently gained FDA approval for Journavx, a novel non-opioid pain medication [6][7] - Despite a recent 15% stock decline and an earnings miss, Vertex is still rated as a Moderate Buy with an average price target of $515, indicating potential upside [8] Regeneron Pharmaceuticals - Regeneron Pharmaceuticals, known for its blockbuster drug Eyelea, reported over $14 billion in sales last year and has expanded its portfolio with drugs like Dupixent and Kevzara [9][10] - Although Regeneron's stock has dropped over 45% in the past year, analysts maintain a consensus Moderate Buy rating with an average price target of $892, suggesting significant upside potential [12] Akero Therapeutics - Akero Therapeutics focuses on liver disease treatments, particularly efruxifermin for metabolic dysfunction-associated steatohepatitis (MASH), currently in Phase 3 trials [13][14] - The stock saw a significant increase in January following positive Phase 2 trial results, and analysts unanimously rate it as a Buy, with a consensus price target of $76, indicating over 90% upside potential [14]

Group 1 - Albert Anthony is a Croatian-American media personality and analyst for financial media platforms Investing.com and Seeking Alpha, focusing on dividend stocks and general market commentary [1] - Since 2023, Albert Anthony has gained over 1,000 followers and has covered more than 200 companies across multiple sectors [1] - He has experience as an analyst in the IT sector and was part of the IT team at a top 10 financial firm in the US [1] Group 2 - Albert Anthony holds a B.A. from Drew University and has completed coursework through the Corporate Finance Institute and Coursera [1] - In 2025, he plans to launch a new book on Amazon discussing his methodology as an analyst and how he rates stocks [1] - The Albert Anthony brand is owned by Albert Anthony & Co., a sole proprietorship registered in Austin, Texas [1]

Core Insights - Regeneron Pharmaceuticals is set to present new data from its oncology and hematology portfolio at the 2025 ASCO Annual Meeting, focusing on checkpoint inhibitors and bispecific antibodies for difficult-to-treat cancers [1][2][3] Oncology Developments - The company will showcase 18 presentations, including updates on the PD-1 inhibitor Libtayo and the investigational bispecific antibody linvoseltamab, which has shown promise in relapsed or refractory multiple myeloma [1][2] - Notable presentations include the Phase 3 C-POST trial results for Libtayo in high-risk cutaneous squamous cell carcinoma, scheduled for an oral session on May 31 [2][3] - Investigational combinations of linvoseltamab with proteasome inhibitors will also be highlighted in rapid oral presentations on June 2 [3] Hematology Insights - Regeneron will debut results from the LINKER-MM2 trial, exploring linvoseltamab combinations with carfilzomib or bortezomib in relapsed/refractory multiple myeloma [3][4] - The company will present findings from a randomized Phase 2 trial of vidutolimod in combination with anti-PD-1 therapy for stage 3 resectable melanoma on June 3 [4] Pipeline Overview - Regeneron's oncology pipeline includes a range of investigational therapies targeting over 30 types of solid tumors and blood cancers, with nearly half of its pipeline dedicated to oncology assets [11][26] - The company emphasizes its commitment to transforming cancer treatment through innovative therapies and collaborations [12][26] Regulatory Status - Libtayo is currently FDA-approved for several indications, while linvoseltamab and odronextamab are under review with target action dates of July 10, 2025, and July 30, 2025, respectively [9][11]

Core Insights - Regeneron Pharmaceuticals is set to present 24 abstracts on Dupixent at the American Thoracic Society International Conference 2025, focusing on its clinical data and real-world analyses in chronic obstructive pulmonary disease (COPD) and asthma [1][2][3] COPD Insights - The data from pivotal Phase 3 trials (BOREAS and NOTUS) will demonstrate Dupixent's effectiveness in reducing exacerbations and improving lung function in COPD patients, including those with and without emphysema [3][4] - The majority of patients in these trials had chronic bronchitis (≥95%) and over 30% had emphysema, with Dupixent showing sustained improvements in multiple spirometry measures over 52 weeks compared to placebo [3] - A late-breaking poster will present a win-ratio analysis assessing the likelihood of avoiding severe events such as death and hospitalization in COPD patients treated with Dupixent versus placebo [4] Asthma Insights - Late-breaking data will highlight Dupixent's impact on mucus burden and its efficacy in reducing exacerbations in children aged 6 to 11 years, regardless of disease duration [6][7] - The safety profile of Dupixent in asthma trials aligns with its known profile, with common adverse events including injection site reactions and viral infections [7] Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways, addressing type 2 inflammation in various chronic diseases [13][14] - It has received regulatory approvals in over 60 countries for multiple indications, including COPD, asthma, and other allergic conditions, with more than 1 million patients currently treated globally [14][16] Development and Research - Dupixent is being jointly developed by Regeneron and Sanofi, with ongoing studies exploring its efficacy in a range of diseases driven by type 2 inflammation [16][17] - The Dupixent development program has involved over 60 clinical trials with more than 10,000 patients, demonstrating significant clinical benefits [16]

Core Insights - Regeneron Pharmaceuticals reported a decline in first-quarter adjusted earnings per share to $8.22, down 14% year-over-year, missing the consensus estimate of $8.82 [1] - The company's sales for the first quarter were $3.03 billion, a 4% decrease from the previous year, also falling short of the consensus of $3.29 billion [1] - U.S. net sales for Eylea HD and Eylea decreased by 26% year-over-year to $1.04 billion, which included $307 million from Eylea HD [1] Sales Performance - Net product sales of Eylea HD increased in the first quarter of 2025 compared to the first quarter of 2024, primarily due to higher sales volumes [2] - However, Eylea's net product sales were negatively impacted by increased competition from other anti-VEGF products and the transition of patients to Eylea HD [2][7] Collaboration Revenue - Sanofi collaboration revenue increased in the first quarter of 2025, driven by higher profits from the commercialization of antibodies, amounting to $1.018 billion compared to $804 million in the first quarter of 2024 [3] Manufacturing Expansion - Regeneron announced a significant expansion of its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotechnologies to produce bulk drug products at their North Carolina campus [4] - The company revised its 2025 GAAP gross margin guidance to 83%-84%, down from 84%-85%, and adjusted gross margin guidance to 86%-87%, down from 87%-88% [4] Regulatory Developments - The European Commission granted conditional marketing approval to Regeneron's Lynozyfic (linvoseltamab) for treating adults with relapsed and refractory multiple myeloma [5] - The FDA accepted the Biologics License Application for linvoseltamab in the U.S., with a target action date of July 10, 2025 [5] Stock Performance - Following the announcements, Regeneron stock experienced a decline of 6.38%, trading at $571.90 [5]

Core Viewpoint - Regeneron Pharmaceuticals reported disappointing first-quarter 2025 results, with adjusted EPS of $8.22, missing estimates and down 14% year-over-year, primarily due to lower revenues and higher operating expenses [1][2][17] Financial Performance - Total revenues decreased 4% year-over-year to $3 billion, missing the Zacks Consensus Estimate of $3.27 billion, driven by lower sales of Eylea and Libtayo [2][17] - Eylea sales in the U.S. plummeted 39% year-over-year to $736 million, impacted by increased competition and market share loss [4][17] - Total Eylea and Eylea HD sales in the U.S. were $1 billion, down 26% year-over-year, also missing estimates [7][17] - Collaboration revenues from Sanofi and Bayer totaled $1.53 billion, up 20.9% year-over-year, exceeding estimates [8][9] Product Performance - Sanofi's collaboration revenues increased 30% to $1.2 billion, driven by higher Dupixent sales, which rose 19% year-over-year to $3.7 billion [9] - Libtayo sales were $285.1 million, up 8% year-over-year, but missed estimates [10] - Eylea HD generated $307 million in revenues, a 54% increase year-over-year, but total Eylea and Eylea HD sales were still down significantly [6][7] Cost and Expenses - Gross margin decreased to 85% from 89% due to higher inventory write-offs and reserves [11] - Adjusted R&D expenses rose 6% year-over-year to $1.2 billion, while adjusted SG&A expenses decreased 8% to $537 million [11] Shareholder Actions - The board authorized a new share repurchase program for up to $3 billion, with $1.052 billion repurchased in Q1 2025 [12] - A cash dividend of $0.88 per share was declared in April 2025 [12] Regulatory Updates - The FDA approved a label expansion for Dupixent and accepted applications for Eylea HD and other drugs, but also issued complete response letters for some applications [13][14][15][16] Strategic Developments - Regeneron entered a 10-year agreement with Fujifilm Diosynth Biotechnologies to enhance manufacturing capacity in the U.S. [19]

Financial Data and Key Metrics Changes - In Q1 2025, total revenues were $3 billion, driven by higher collaboration revenue from Sanofi and increased U.S. net sales of EYLEA HD compared to the prior year [41] - Diluted net income per share was $8.22, with net income of $928 million [42] - Gross margin on net product sales was 85%, reflecting higher inventory write-offs and a change in product mix [45] - Free cash flow generated in Q1 was $816 million, with cash and marketable securities totaling $17.6 billion and debt of approximately $2.7 billion [46] Business Line Data and Key Metrics Changes - EYLEA U.S. net sales were $736 million, down 39% year-over-year, primarily due to lower physician demand and increased competition [7][29] - EYLEA HD U.S. sales were $307 million, up 54% year-over-year, with physician unit demand growing by 5% [8][30] - DUPIXENT achieved global net sales of $3.7 billion, representing a 20% year-over-year increase, with U.S. sales growing 19% [32] - Libtayo's global net sales grew 8% year-over-year to $285 million, with U.S. sales reaching $193 million, up 21% [38] Market Data and Key Metrics Changes - The branded anti-VEGF category contracted due to increased usage of low-cost off-label repackaged Avastin, which gained approximately 6 percentage points in market share [7][28] - EYLEA and EYLEA HD captured 41% of the anti-VEGF category, maintaining market leadership despite competitive pressures [28] - DUPIXENT continues to lead in new-to-brand prescription share across all approved indications, except for chronic spontaneous urticaria [11][34] Company Strategy and Development Direction - The company aims to capitalize on multiple near-term opportunities across its portfolio, including product enhancements and new medicine launches [27] - Significant investments in R&D are planned, with approximately 45 product candidates in clinical development [12][41] - The company is focused on maintaining leadership in the anti-VEGF category while promoting the adoption of EYLEA HD as the new standard of care [30] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a mixed performance in Q1 2025, with challenges in the retinal franchise but positive developments in other commercial areas and pipeline advancements [6][7] - The company remains committed to investing heavily in R&D and delivering scientific breakthroughs while maximizing growth opportunities from existing brands [13] - Management expressed confidence in the potential for EYLEA HD and DUPIXENT to continue delivering significant growth [12][34] Other Important Information - The company plans to return capital to shareholders through share repurchases and dividends, with $1.1 billion worth of shares repurchased in Q1 [48] - A new agreement with Fujifilm Diosynth Biotechnologies will invest over $3 billion to nearly double U.S. large-scale manufacturing capacity [46][47] - The company updated its 2025 gross margin guidance to be in the range of 86% to 87% due to higher-than-expected inventory write-offs [49] Q&A Session Summary Question: Can you elaborate on the EYLEA HD CRL for the prefilled syringe? - Management explained that the FDA's questions relate to a third-party component supplier, and they believe the key issue is being addressed. They expect a resolution could be quick, similar to previous CRLs [52][56] Question: How does the company prioritize indications for Factor XI antibodies? - The company prioritizes indications based on the potential to demonstrate benefits in anticoagulation and bleeding risk profiles, with plans to enroll in phase three studies this year [61][63] Question: What are the updated thoughts on foundation funding for EYLEA? - Management discussed the complexities of patient assistance funding and the potential for a matching program to stimulate contributions from others, emphasizing the need for broader support [66][71] Question: Is there acknowledgment of unsatisfactory regulatory performance? - Management took responsibility for the CRLs, attributing them to increased scrutiny by the FDA on contract manufacturers and expressing confidence in their regulatory team's capabilities [87][90]

Company Performance - Regeneron reported quarterly earnings of $8.22 per share, missing the Zacks Consensus Estimate of $8.43 per share, and down from $9.55 per share a year ago, representing an earnings surprise of -2.49% [1] - The company posted revenues of $3.03 billion for the quarter, missing the Zacks Consensus Estimate by 7.53%, and down from $3.15 billion year-over-year [2] - Over the last four quarters, Regeneron has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times [2] Stock Outlook - Regeneron shares have declined approximately 14.3% since the beginning of the year, compared to a 6% decline in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is $10.12 on revenues of $3.52 billion, and for the current fiscal year, it is $38.75 on revenues of $14.32 billion [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Regeneron belongs, is currently in the top 31% of over 250 Zacks industries, indicating a favorable industry outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that the industry outlook can significantly impact stock performance [5][8]