Core Viewpoint - The U.S. stock market is stabilizing after a tech-led sell-off, with investors focusing on futures movements, economic data, and corporate news amid concerns about AI stock valuations and Federal Reserve interest rate policy [1]. Premarket Activity and Futures Movements - U.S. stock futures are trending higher, indicating a potential rebound after Thursday's declines, with Nasdaq 100 futures up 0.17%, S&P 500 futures up 0.31%, and Dow Jones Industrial Average futures up 0.43% [2]. Major Market Indexes - Major U.S. indexes experienced significant losses on Thursday, with the Nasdaq Composite down 2.15%, S&P 500 down 1.56%, and Dow Jones down 0.84%, marking a 2.25-month low for the S&P 500 and a 5-week low for the Dow [4]. Upcoming Market Events and Economic Data - Key economic data releases on November 21 include Johnson/Redbook Weekly Sales, NAHB Housing Market Index, Net Long-term TIC Flows, and preliminary Manufacturing and Services PMI data for various regions [6]. Federal Reserve Interest Rate Expectations - Market sentiment suggests a reduced likelihood of a rate cut in December, with only a 35% chance of a 25-basis-point cut, down from 63.8% a week prior [7]. Major Stock News and Corporate Announcements - Gap shares surged 5.6% due to strong comparable sales, while Intuit gained 3% after reporting strong fiscal results despite light guidance [9]. - Walmart's shares rose over 6% after raising its 2026 net sales forecast, and Regeneron Pharmaceuticals climbed over 4% following FDA approval for its drug [10]. - PACS Group saw a significant jump of over 55% after completing restatements, while Solventum rose over 2% after an acquisition [10][11]. Notable Declines in the Tech Sector - Nvidia shares fell 3.2% despite better-than-expected Q3 results, amid concerns over AI stock valuations, with other major tech stocks also closing lower [12]. - Bath & Body Works plummeted over 24% after missing Q3 sales expectations, and Jacobs Solutions fell over 10% due to disappointing revenue [13].

US Sep average hourly earnings remained unchanged from Aug at +3.8% y/y, stronger than expectations of +3.7% y/y.US Sep nonfarm payrolls rose by +119,00 beating expectations of +51,000 and signaling a stronger labor market000. The Sep unemployment rate unexpectedly rose by +0.1 to a nearly four-year high of 4.4%, showing a weaker labor market than expectations of no change at 4.3%.US weekly initial unemployment claims fell by -8,000 to 220,000, showing a stronger labor market than expectations of 227,000. H ...

Hawkish comments today from Cleveland Fed President Beth Hammack were bearish for stocks, as she said, "Lowering interest rates to support the labor market risks prolonging this period of elevated inflation, and it could also encourage risk-taking in financial markets."The US Nov Philadelphia Fed business outlook survey rose +11.1 to -1.7, weaker than expectations of +1.0.US Sep average hourly earnings remained unchanged from Aug at +3.8% y/y, stronger than expectations of +3.7% y/y.US Sep nonfarm payrolls ...

Financial Data and Key Metrics Changes - Regeneron reported total revenues of $3.8 billion for Q3 2025, reflecting a 1% increase compared to the prior year, driven by higher collaboration revenue from Sanofi and growth in net sales of Dupixent and Libtayo, partially offset by lower EYLEA sales [39][40] - Diluted net income per share was $11.83, with net income reaching $1.3 billion [39] - Gross margin on net product sales was 86%, lower than the previous year due to a changing product mix and increased investments in manufacturing operations [41] Business Line Data and Key Metrics Changes - Dupixent achieved worldwide net sales of $4.9 billion in Q3 2025, a 26% increase on a constant currency basis compared to the prior year, with U.S. sales growing 28% to $3.6 billion [35][39] - Libtayo's global net sales were $365 million, up 24% year-over-year on a constant currency basis, with U.S. sales growing 12% [36][39] - EYLEA HD U.S. net sales reached $431 million, an all-time high, while EYLEA sales decreased 10% to $681 million due to competitive dynamics and patient affordability issues [10][32] Market Data and Key Metrics Changes - Dupixent is positioned to address over 4 million patients in the U.S., with more than 1.3 million patients currently being treated globally [8] - Libtayo is the market leader in advanced non-melanoma skin cancers and has recently been approved for high-risk adjuvant cutaneous squamous cell carcinoma, with an estimated 10,000 eligible patients in the U.S. [9][37] - EYLEA HD now represents approximately 40% of Regeneron's U.S. retina franchise, with expectations for moderate to high single-digit demand growth in the upcoming quarter [32] Company Strategy and Development Direction - Regeneron is focused on maximizing growth from existing brands while launching new products and indications, with significant investments in R&D to support its innovative pipeline [16][39] - The company is engaged in discussions with the U.S. government to lower drug costs while preserving innovation and has committed to investing over $7 billion in infrastructure and manufacturing facilities [15][39] - The pipeline includes advancements in immunology, oncology, and rare diseases, with multiple positive Phase III data readouts expected to drive future growth [12][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing discussions with the U.S. government regarding drug pricing and the importance of equitable global systems for innovation [14][15] - The company anticipates continued growth across its commercial portfolio, particularly from Dupixent, Libtayo, and EYLEA HD, while preparing for upcoming label enhancements [16][32] - Regeneron expects a mid-teens percentage increase in R&D expenses in 2026 to support its innovative pipeline [43] Other Important Information - The FDA issued a complete response letter for EYLEA HD's prefilled syringe supplemental BLA due to unresolved inspection findings at a contract manufacturing facility [11] - Regeneron has made significant progress in its clinical trials for various programs, including a promising Phase III trial for a treatment addressing fibrodysplasia ossificans progressiva [30] Q&A Session Summary Question: Changes in EYLEA's commercial strategy and pricing - Management acknowledged competitive issues and emphasized the importance of EYLEA HD's clinical efficacy and safety in driving its performance [45][48] Question: Future manufacturing expansion plans - Management indicated openness to using the balance sheet for large deals if the right opportunity arises and highlighted ongoing investments in domestic manufacturing [54][56] Question: Importance of label enhancements for EYLEA HD - Management noted that label enhancements are crucial for providing dosing flexibility and improving market share [59][60] Question: Insights from previous IL-33 trials for COPD - Management refrained from commenting on specific insights but mentioned upcoming discussions with the FDA to guide future strategies [63][64] Question: Probability of approval for RVO and four-week dosing filing - Management discussed the complexities of the approval timeline and the need for the new filler to undergo review before resubmission [66][68] Question: Changes to regulatory manufacturing teams to prevent CRLs - Management clarified that issues were not due to internal regulatory problems but rather manufacturing challenges, emphasizing the need for their own filling capabilities [72][74] Question: Factor XI antibody program and future opportunities - Management highlighted the focus on understanding the benefit-risk ratio for their antibodies and the potential for broader applications beyond current indications [78][80]

Financial Data and Key Metrics Changes - Regeneron reported total revenues of $3.8 billion for Q3 2025, reflecting a 1% increase compared to the prior year, driven by higher collaboration revenue from Sanofi and growth in net sales of Dupixent and LIBTAYO, partially offset by lower EYLEA sales [39][40] - Diluted net income per share was $11.83, with net income reaching $1.3 billion [39] - Gross margin on net product sales was 86%, lower than the previous year due to a changing product mix and increased investments in manufacturing operations [41] Business Line Data and Key Metrics Changes - Dupixent achieved worldwide net sales of $4.9 billion in Q3 2025, a 26% increase year-over-year at constant currency, with U.S. sales growing 28% [7][35] - LIBTAYO's global net sales were $365 million, up 24% on a constant currency basis, with U.S. sales growing 12% [9][36] - EYLEA HD reached U.S. net sales of $431 million, an all-time high, while EYLEA sales decreased 10% to $681 million due to competitive dynamics and patient affordability issues [10][33] Market Data and Key Metrics Changes - Dupixent is positioned to address over 4 million patients in the U.S., with more than 1.3 million patients currently treated globally [8] - LIBTAYO is the market leader in advanced non-melanoma skin cancers and has recently been approved for high-risk adjuvant cutaneous squamous cell carcinoma, with an estimated 10,000 eligible patients in the U.S. [9][37] - EYLEA HD now represents approximately 40% of Regeneron's U.S. retina franchise, with expectations for moderate to high single-digit demand growth in the upcoming quarter [34] Company Strategy and Development Direction - Regeneron is focused on maximizing growth from existing brands while launching new products and indications, with significant investments in R&D to support its pipeline [16][39] - The company is engaged in discussions with the U.S. government to lower drug costs while preserving innovation and has committed over $7 billion to infrastructure and manufacturing in the U.S. [15][39] - The pipeline includes advancements in immunology, oncology, and rare diseases, with positive Phase III data for several programs [12][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing discussions with the U.S. government regarding drug pricing and the importance of U.S. manufacturing for national security [15] - The company anticipates continued growth across its commercial portfolio, with a focus on addressing unmet patient needs and expanding treatment options [16][39] - Regeneron expects to advance multiple registrational programs in 2026, with a mid-teens percentage increase in R&D expenses planned [43] Other Important Information - The FDA issued a complete response letter for the prefilled syringe supplemental BLA for EYLEA HD due to unresolved inspection findings at a third-party facility [11] - Regeneron is advancing its siRNA portfolio and has made significant progress in clinical trials for various conditions, including ultra-rare diseases [29][30] Q&A Session Summary Question: Changes in EYLEA commercial strategy and pricing - Management acknowledged competitive issues and emphasized the importance of EYLEA HD's clinical efficacy and safety in driving its performance [45][48] Question: Future balance sheet utilization for large deals - Management indicated openness to using the balance sheet for strategic opportunities and highlighted ongoing investments in domestic manufacturing [54][56] Question: Importance of label enhancements for EYLEA HD - Management noted that label enhancements are crucial for providing dosing flexibility and improving market share [59][60] Question: Insights from IL-33 COPD trials - Management refrained from commenting on specific insights but indicated plans for further discussions with the FDA [63][64] Question: Probability of approval for RVO and dosing filing - Management discussed the complexities of the approval process and the timeline for the new filler, expressing cautious optimism [66][68] Question: Internal changes to prevent CRLs - Management clarified that issues were not due to internal regulatory problems but rather manufacturing challenges, emphasizing ongoing efforts to rectify the situation [72][75] Question: Factor XI antibody program and future opportunities - Management highlighted the focus on understanding the benefit-risk ratio and the potential for broader applications of the Factor XI antibodies [78][80]

Financial Data and Key Metrics Changes - Regeneron reported total revenues of $3.8 billion for Q3 2025, reflecting a 1% increase compared to the prior year, driven by higher collaboration revenue from Sanofi and growth in net sales of Libtayo and EYLEA HD, partially offset by lower EYLEA sales [34][35] - Diluted net income per share was $11.83, with net income of $1.3 billion [34] - Gross margin on net product sales was 86%, lower than the previous year due to a changing product mix and higher investments in manufacturing operations [36] Business Line Data and Key Metrics Changes - Dupixent achieved worldwide net sales of $4.9 billion, growing 26% year-over-year at constant currency, with U.S. sales reaching $3.6 billion, reflecting a 28% increase [28][29] - Libtayo's global net sales were $365 million, up 24% on a constant currency basis, with U.S. sales growing 12% year-over-year [27][30] - EYLEA HD U.S. net sales reached $431 million, an all-time high, driven by robust physician demand, while EYLEA sales decreased 10% to $681 million [27][28] Market Data and Key Metrics Changes - Dupixent is positioned to address over 4 million patients in the U.S., with more than 1.3 million patients currently treated globally [6] - Libtayo is now the second most commonly prescribed immunotherapy for newly diagnosed lung cancer patients, with strong demand in non-melanoma skin cancers [31] - EYLEA HD represents approximately 40% of Regeneron's U.S. retina franchise, with expectations for continued demand growth [28] Company Strategy and Development Direction - Regeneron is focused on maximizing growth from existing brands while launching new products and indications, with significant investments in R&D to support its pipeline [13][39] - The company is committed to discussions with the U.S. government to lower drug costs while preserving innovation and has plans to invest over $7 billion in manufacturing infrastructure [12][39] - Future product enhancements for EYLEA HD are anticipated to unlock its commercial potential, including a four-week dosing interval and new indications [8][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about ongoing discussions with the U.S. administration regarding drug pricing and the importance of U.S. manufacturing for national security [12] - The company expects continued growth in its commercial portfolio, driven by strong performance across Dupixent, Libtayo, and EYLEA HD [13][39] - Regeneron anticipates a mid-teens percentage increase in R&D expenses in 2026 to support its innovative pipeline [39] Other Important Information - Regeneron generated $3.2 billion in free cash flow through the first nine months of 2025 and repurchased approximately $2.8 billion of its shares [37] - The company plans to submit a U.S. regulatory application for cimdisiren in the first quarter of 2026, pending FDA discussions [22] Q&A Session Summary Question: Changes in EYLEA commercial strategy and pricing - Management acknowledged competitive issues and emphasized the importance of EYLEA HD's clinical efficacy and safety in driving its performance [41][43][45] Question: Future manufacturing expansion plans - Management indicated openness to using the balance sheet for large deals if the right opportunity arises and highlighted ongoing investments in domestic manufacturing [50][52] Question: Importance of label enhancements for EYLEA HD - Management noted that label enhancements are crucial for clinics to have dosing flexibility and improve inventory management [55][56] Question: Insights from IL-33 COPD trials - Management refrained from commenting on specific insights but mentioned upcoming discussions with the FDA to determine the strategy for future trials [59][60] Question: Probability of approval for RVO and dosing filing - Management discussed the complexities of the approval timeline and the need for the new filler to undergo review before resubmission [62][63] Question: Changes to regulatory manufacturing teams - Management clarified that issues were not due to internal regulatory problems but rather manufacturing challenges, emphasizing the need for their own filling capabilities [66][68]

Third quarter 2025 revenues increased 1% to $3.75 billion versus third quarter 2024Dupixent® global net sales (recorded by Sanofi) increased 27% to $4.86 billion EYLEA HD® U.S. net sales increased 10% to $431 million; total EYLEA HD and EYLEA® U.S. net sales decreased 28% to $1.11 billion GAAP EPS of $13.62 and non-GAAP EPS(a) of $11.83; third quarter 2025 includes unfavorable $0.68 impact from acquired IPR&D chargeFDA approved Libtayo® as the first and only immunotherapy for high-risk adjuvant cutaneous sq ...

Regeneron Pharmaceuticals FY Conference Summary Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Date of Conference**: September 24, 2025 Key Points Commercial Performance - **EYLEA HD Performance**: - 5% sequential growth in demand in Q1 and 16% in Q2 attributed to effective commercial execution and physician-patient education [4][5] - Demand is expected to increase further once headwinds are resolved, particularly regarding reimbursement and prefilled syringe preferences [5][6] - Upcoming PDUFA dates: late October for prefilled syringe and late November for RVO and Q4 dosing [8] Pipeline Developments - **DUPIXENT**: - Strong performance across all eight approved indications, with ongoing growth in established indications like asthma and new launches in COPD, CSU, and bullous pemphigoid [15][16] - 70% of top-tier pulmonologists have prescribed DUPIXENT for COPD, indicating positive reception [18] - Strategic focus on lifecycle opportunities and adjacent type 2 pathways to maintain growth post-DUPIXENT exclusivity expiration in 2031 [21][23] - **Oncology Pipeline**: - Recent approvals for bispecifics, with a focus on Linezyth for multiple myeloma [24] - Plans to launch studies in earlier lines of treatment, combining Linezyth with carfilzomib, expected by the end of 2025 [26][28] - **Complement and Factor XI Programs**: - Promising data in myasthenia gravis (MG) with a focus on quarterly dosing advantages [35] - Factor XI program aims to reduce bleeding risks associated with anticoagulants, with ongoing Phase 3 studies [39][40] R&D and Capital Allocation - **R&D Investment Strategy**: - Focus on internal R&D as a primary capital allocation priority, with a robust pipeline driving long-term shareholder value [50][52] - Share repurchase program and dividend implementation to enhance shareholder returns [51] - **External Innovation**: - Active exploration of licensing and collaboration opportunities, though M&A remains a secondary focus [50][55] Market Outlook and Strategic Vision - **Pipeline Potential**: - The breadth and depth of the pipeline are viewed as unprecedented, with confidence in the ability to drive future growth [57][58] - Ongoing preclinical opportunities in various therapeutic areas, including genetics and rare diseases, are expected to yield significant advancements [59] Regulatory and Competitive Landscape - **Biosimilars Impact**: - Gradual uptake of existing biosimilars noted, with potential for increased pricing pressure as more entrants are expected in 2026 [11][12] - **DTC Advertising Restrictions**: - Generalized communication from the administration regarding DTC advertising, with no specific implications for Regeneron noted [19] Conclusion - Regeneron Pharmaceuticals is positioned for continued growth through its strong product pipeline, strategic R&D investments, and proactive market engagement. The company remains focused on addressing competitive pressures while leveraging its innovative capabilities to enhance patient outcomes and shareholder value.

Core Viewpoint - The U.S. FDA issued a Complete Response Letter (CRL) for Scholar Rock's apitegromab Biologics License Application (BLA) due to observations from a routine inspection of Catalent Indiana LLC, which is not specific to the drug itself [1][2]. Group 1: FDA Response and Observations - The CRL did not raise any concerns regarding the efficacy and safety data of apitegromab or the third-party drug substance manufacturer [2]. - Catalent Indiana submitted a comprehensive response to the FDA's observations in early August 2025 and is actively working on corrective actions [4]. - Scholar Rock plans to resubmit the apitegromab BLA following Catalent Indiana's remediation of the FDA observations [4]. Group 2: Market Authorization and Future Plans - Outside the U.S., the apitegromab marketing authorization application (MAA) is under review by the European Medicines Agency, with a decision expected by mid-2026 [5]. - The European launch of apitegromab is anticipated in the second half of 2026, with Germany expected to be the first market for patient access [5]. Group 3: Related Industry Developments - Regeneron Pharmaceuticals anticipates delays in regulatory approvals for its EYLEA HD applications due to observations from an FDA inspection at Catalent Indiana, which also affects Scholar Rock [6]. - Scholar Rock's stock price increased by 1.24% to $32.99 following the news [7].

Financial Data and Key Metrics Changes - Regeneron reported a strong quarter with EYLEA HD showing the strongest growth in the branded category within the anti-VEGF category, with demand growth of approximately 16% in the quarter compared to 5% in the previous quarter [7][12] - The overall franchise performance of EYLEA and EYLEA HD accounts for 60% of the anti-VEGF branded category, indicating a stable growth trajectory [25] Business Line Data and Key Metrics Changes - EYLEA HD has been in the market for about two years and is less impacted by affordability challenges compared to EYLEA, which is a larger product [15][21] - The introduction of a prefilled syringe for EYLEA HD is expected to enhance convenience for busy retina practices, which treat many patients daily [10][33] Market Data and Key Metrics Changes - The market for EYLEA HD is complicated, with affordability issues affecting the branded category due to high out-of-pocket costs for patients on Medicare plans [12][21] - Regeneron has launched a program to match donations to help patients offset these costs, although contributions have been lower than in previous years [12][13] Company Strategy and Development Direction - Regeneron aims to broaden the label for EYLEA HD, including potential enhancements such as Q4 weekly dosing and the RVO indication, which was a $1 billion indication for EYLEA in 2024 [11][34] - The company is focused on maintaining competitive readiness across its product lines, particularly with DUPIXENT, which continues to grow despite increasing competition [46][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of EYLEA HD and DUPIXENT, highlighting the importance of upcoming regulatory approvals and market expansions [41][86] - The company is actively working on resolving manufacturing issues with its partner, Catalent, to ensure timely FDA approvals for new product submissions [35][36] Other Important Information - Regeneron is exploring additional indications for its C5 franchise, with ongoing studies in myasthenia gravis and geographic atrophy, indicating a strong pipeline for future growth [70] - The company is also considering a potential third Phase III study for itapacumab, pending discussions with regulatory authorities [76] Q&A Session Summary Question: How has the strength of high dose EYLEA been impacted by charity contributions? - Management indicated that the strength seen in high dose EYLEA is primarily due to the product's performance rather than charity contributions, which have not yet significantly impacted sales [14][15] Question: How is Regeneron addressing competition from biosimilars? - Management noted that while there is selective interest in biosimilars, many practices prefer EYLEA and EYLEA HD due to their established efficacy and safety profiles [27][30] Question: What are the expectations for upcoming PDUFAs? - Management confirmed that all submissions for Q4 dosing, RVO, and prefilled syringe approvals have been delayed due to manufacturing issues, but they remain confident in the outcomes once resolved [35][40] Question: What is the growth outlook for DUPIXENT? - Management highlighted that DUPIXENT continues to grow at over 20%, with multiple indications contributing to its success, and they expect this trend to continue [43][46] Question: How does Regeneron plan to position its new product in a crowded market? - Management expressed excitement about the clinical data for their new product and emphasized the importance of efficacy and convenience in positioning against competitors [63][64]