8 January 2026 | 5:01AM EST Equity Research Americas Healthcare: Biotechnology: Constructive backdrop for 2026 Following strong performance for the sector exiting 2025 (XBI +35% vs. S&P 500 +16%), driven by the convergence of a number of key factors, notably, broader market dynamics (e.g., macro/AI-trade rotations and rates), easing policy risks (e.g., Most-Favored-Nations (MFN) drug pricing deals), and improving fundamentals (e.g., stable/upward large-cap estimate revisions and SMID catalyst execution), we ...

Could the tide be turning for Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) after a surprising shift in analyst sentiment?As investors digest the latest upgrade, what factors are driving this newfound optimism for the biotech giant?Bank of America (BofA) Securities on Wednesday upgraded Regeneron Pharmaceuticals, citing several factors, including higher sales for key products.Analyst Tazeen Ahmad upgraded Regeneron from Underperform to Buy, and raised the price forecast from $627 to $860.BofA's prior Underpe ...

Core Viewpoint - BofA Securities upgraded Regeneron Pharmaceuticals from Underperform to Buy and raised its price target to $860.00 from $627.00, leading to a more than 2% increase in stock price during pre-market trading [1] Group 1: Eylea and Dupixent Outlook - BofA's previous bearish stance on Eylea SD has largely played out, with consensus expectations declining [2] - The firm is more optimistic about Eylea HD following multiple label updates, with estimates now significantly above consensus [2] - Additional growth potential is anticipated from Dupixent, which is marketed in partnership with Sanofi [2] Group 2: Pipeline and Future Catalysts - The analyst pointed out pipeline optionality for 2026, including a Phase 3 melanoma readout for fianlimab, a LAG-3 antibody, expected in the first half of the year [3] - Potential positive updates at a competitor conference in January are seen as another catalyst for Regeneron [3] - BofA expects a favorable outcome from Regeneron's MFN agreement with the White House, which may alleviate any remaining MFN-related concerns, including a likely exemption from MFN CMMI demonstration projects [3]

Core Insights - The medical sector is increasingly adopting artificial intelligence (AI), enhancing drug synthesis, device creation, and diagnostic accuracy [2][3] Group 1: Eli Lilly and Co. (LLY) - Eli Lilly focuses on cardiometabolic health, neuroscience, oncology, and immunology, which are high-growth areas with significant commercial potential [5] - Demand for LLY's GLP-1 drugs, Mounjaro and Zepbound, remains strong, contributing to robust sales in 2025 [6] - LLY is advancing its pipeline with an oral GLP-1 obesity pill, orforglipron, expected to launch next year [7] - Eli Lilly is collaborating with OpenAI for novel medicine discovery and invested $409 million in Genetic Leap for AI-driven drug discovery [7] - The company is building a supercomputer with NVIDIA to enhance its AI capabilities, with expected revenue and earnings growth rates of 22.3% and 41.3% respectively for the current year [8] - LLY has a return on equity (ROE) of 109.5%, significantly higher than the industry average of 37% [9] Group 2: Medtronic plc (MDT) - Medtronic is integrating AI into its solutions to improve patient care and operational efficiency, including an AI-powered surgical video management platform [10] - The GI Genius project enhances colorectal cancer detection, increasing survival rates by identifying polyps that may be missed [11] - Medtronic's partnerships leverage AI to optimize cardiac procedures and improve diagnostic precision, driving growth in the medtech sector [12] - The company has an expected revenue and earnings growth rate of 7.5% and 2.7% respectively for the current year [14] - MDT has a ROE of 14.9%, outperforming the industry average of -2.5% [14] Group 3: Intuitive Surgical Inc. (ISRG) - Intuitive Surgical is embedding AI into its robotic systems, providing objective performance indicators for surgeons [15] - The company is piloting telecollaboration for remote surgical support, enhancing training and decision-making [16] - ISRG's revenue and earnings growth rates are expected to be 14.3% and 11.1% respectively for the current year [19] - ISRG has a ROE of 15.1%, compared to the industry's ROE of -18.7% [19] Group 4: Regeneron Pharmaceuticals Inc. (REGN) - Regeneron utilizes AI and machine learning for drug target identification, clinical trial optimization, and precision medicine [20] - The company has seen revenue growth driven by strong performance from Dupixent and Libtayo, despite declining sales of Eylea [21] - REGN's expected revenue and earnings growth rates are 4.9% and -0.4% respectively for the current year [23] - REGN has a ROE of 13.8%, significantly higher than the industry's ROE of -65.41% [23] Group 5: Johnson & Johnson (JNJ) - Johnson & Johnson's MedTech division is focused on AI technologies for surgical robotics and digital surgery analytics [24] - The company has developed the Ottava robotic surgery platform and the Caresurgical/VELYS digital surgery systems, enhancing procedure planning [25] - JNJ has an expected revenue and earnings growth rate of 5% and 5.7% respectively for the current year [26] - JNJ has a ROE of 32.7%, compared to the industry's ROE of 37% [26]

Core Insights - The medical sector is rapidly adopting artificial intelligence (AI), significantly transforming diagnostics, treatment, and operational efficiency in 2024 [1] - AI-powered diagnostics have become central to enhancing accuracy and speed in medical practices [1] Group 1: AI Adoption in Healthcare - The healthcare sector is typically defensive, characterized by low-beta and dividend-paying stocks, but AI has turned several stocks into potential high-growth providers [2] - Key stocks benefiting from AI integration include Eli Lilly and Co. (LLY), Medtronic plc (MDT), Intuitive Surgical Inc. (ISRG), Regeneron Pharmaceuticals Inc. (REGN), and Johnson & Johnson (JNJ) [2] Group 2: Eli Lilly and Co. (LLY) - Eli Lilly focuses on cardiometabolic health, neuroscience, oncology, and immunology, which are high-growth areas with significant commercial potential [5] - Strong demand for LLY's GLP-1 drugs, Mounjaro and Zepbound, is driving top-line growth, supported by international market launches and increased production [6] - LLY is advancing its pipeline in obesity and diabetes, with an oral GLP-1 obesity pill expected to launch next year [7] - The company is collaborating with OpenAI and investing in AI-driven biotech initiatives, including a $409 million investment in Genetic Leap [9] - LLY has an expected revenue growth rate of 22.3% and earnings growth rate of 41.3% for the current year, with a beta of 0.35 and a dividend yield of 0.6% [9][10] Group 3: Medtronic plc (MDT) - Medtronic is integrating AI into its surgical systems and endoscopy to enhance patient care and operational efficiency [11] - The GI Genius project uses AI algorithms to detect colorectal polyps during colonoscopies, improving cancer survival rates [12] - MDT's partnerships leverage AI to optimize cardiac procedures and improve diagnostic precision, positioning the company for growth in medtech innovation [13] - Medtronic has an expected revenue growth rate of 7.5% and earnings growth rate of 2.7% for the current year, with a beta of 0.71 and a dividend yield of 3% [15] Group 4: Intuitive Surgical Inc. (ISRG) - Intuitive Surgical is embedding AI and digital tools into its robotic ecosystem, enhancing surgical performance metrics [16] - The company is piloting telecollaboration through Intuitive Telepresence, allowing remote surgical support [17] - ISRG has an expected revenue growth rate of 14.3% and earnings growth rate of 11.1% for the current year, with a beta of 0.39 and an ROE of 15.1% [20] Group 5: Regeneron Pharmaceuticals Inc. (REGN) - Regeneron utilizes AI and machine learning for drug target identification, clinical trial optimization, and precision medicine [21] - The company has seen revenue growth driven by strong performance from drugs like Eylea HD and Dupixent, despite declining sales of its lead drug [22] - REGN has an expected revenue growth rate of 4.9% and earnings growth rate of -0.4% for the current year, with a beta of 0.39 and a dividend yield of 0.5% [24] Group 6: Johnson & Johnson (JNJ) - Johnson & Johnson's MedTech division applies AI technologies for surgical robotics and digital surgery analytics [25] - The company has developed the Ottava robotic surgery platform and the Caresurgical/VELYS digital surgery systems, enhancing procedure planning and real-time data sharing [26] - JNJ has an expected revenue growth rate of 5% and earnings growth rate of 5.7% for the current year, with a beta of 0.34 and a dividend yield of 2.5% [27]

Core Insights - Regeneron Pharmaceuticals (REGN) has experienced a strong performance over the past six months, with shares rising 41%, significantly outperforming the industry growth of 22.4% [1][9] - The stock reached a 52-week high of $792.77 on December 24, 2025, indicating robust investor sentiment [1][9] Pipeline and Regulatory Developments - Positive developments in Regeneron's pipeline, particularly the FDA approval of Eylea HD for treating macular edema following retinal vein occlusion (RVO), have bolstered investor confidence [5][9] - Eylea HD sales in the U.S. increased by 10% in Q3 2025, driven by higher volumes and demand, which is crucial as Eylea faces competition from Roche's Vabysmo [10][11] Oncology Portfolio Growth - Regeneron's oncology franchise, led by the PD-1 inhibitor Libtayo, generated $1.03 billion in sales during the first nine months of 2025, reflecting a 21% year-over-year increase [13] - Recent label expansions for Libtayo in Europe and the U.S. enhance its market position and support long-term growth in oncology [14][15] - The FDA's accelerated approval of linvoseltamab-gcpt for multiple myeloma and Ordspono for lymphoma further strengthens Regeneron's oncology portfolio [16][17] Dupixent Sales and Market Expansion - Dupixent continues to be a significant revenue driver for Regeneron, with ongoing label expansions contributing to strong sales growth [18][23] - The recent approval for Dupixent to treat chronic spontaneous urticaria in patients aged 12 and above highlights its expanding market potential [19] Financial Performance and Valuation - Regeneron's shares currently trade at a price/earnings ratio of 22.21X forward earnings, higher than its historical mean of 19X and the large-cap pharma industry's average of 19.26X [20] - The bottom-line estimate for 2025 has decreased, while the estimate for 2026 has increased by $1.97, indicating mixed expectations for future performance [21] Strategic Outlook - Regeneron is diversifying its revenue streams through its oncology portfolio and ongoing label expansions for Dupixent, which reduces reliance on any single product [23] - The company is also exploring opportunities in the obesity market, having entered into an in-licensing agreement to expand its pipeline [24] - Recent positive momentum in the pipeline and regulatory developments has improved the overall outlook for Regeneron, making it an attractive investment opportunity [25]

Financial Data and Key Metrics Changes - The company announced a $7 billion commitment to expand R&D capabilities and domestic manufacturing [6] - The cash balance remains substantial, with ongoing dividends and buybacks, but the company is open to M&A opportunities if the right conditions arise [11][12] Business Line Data and Key Metrics Changes - Eylea HD received recent approvals for RVO and Q4 dosing, with expectations for commercial impact starting in 2026 [17] - Dupixent continues to grow robustly, treating over 1.3 million patients globally, with significant market expansion opportunities in atopic dermatitis and asthma [30][31] Market Data and Key Metrics Changes - The company is actively monitoring the impact of biosimilars on Eylea, noting that any conversions to biosimilars still position patients as candidates for Eylea HD [24] - The COPD launch has shown strong performance, with Dupixent being the best-performing respiratory launch for the company [34] Company Strategy and Development Direction - The company is committed to domestic manufacturing and enhancing internal capabilities while exploring external opportunities for growth [6][12] - The focus remains on investing in the pipeline and fostering innovation to drive long-term shareholder value [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, particularly regarding the Eylea HD enhancements and the ongoing growth of Dupixent [21][30] - The company is closely watching policy changes related to drug pricing and their potential impact on Eylea and other products [26] Other Important Information - The company is preparing for a submission for a prefilled syringe for Eylea HD, expected in the second quarter [18] - Linvoseltamab has shown promising data in the myeloma market, with plans for further studies in earlier lines of therapy [63] Q&A Session Summary Question: Update on policy and macro environment - The company has committed to domestic manufacturing and is in active negotiations regarding drug pricing policies [6][9] Question: Thoughts on M&A and business development - The company is open to M&A opportunities but prioritizes internal investments and collaborations [12][13] Question: Eylea HD commercial impact and competition - Eylea HD enhancements are expected to drive growth starting in 2026, despite current payer issues [21][24] Question: Dupixent growth drivers - Dupixent is benefiting from market expansion in atopic dermatitis and asthma, with significant room for growth [30][31] Question: Linvoseltamab in myeloma - Linvoseltamab has shown best-in-class data among BCMA bispecifics, with ongoing studies to simplify treatment algorithms [62][63]

Financial Data and Key Metrics Changes - The company announced a $7 billion commitment to expand R&D capabilities and domestic manufacturing, indicating a strong focus on internal growth and innovation [6][9] - The company has a substantial cash balance and has initiated dividends and buybacks, reflecting a solid financial position [11] Business Line Data and Key Metrics Changes - Eylea HD received recent approvals for RVO and Q4 dosing, with expectations for commercial impact starting in 2026 [17][18] - Dupixent continues to grow robustly, treating over 1.3 million patients globally, with significant market expansion opportunities in atopic dermatitis and asthma [30][31] Market Data and Key Metrics Changes - The company is actively monitoring the impact of biosimilars on Eylea, noting that while they present challenges, Eylea HD remains a strong competitor [24] - The COPD launch has been successful, with Dupixent showing a significant reduction in exacerbation rates compared to competitors [33][34] Company Strategy and Development Direction - The company is committed to domestic manufacturing and enhancing its R&D capabilities, aiming to meet the demands of its growing pipeline [6][15] - There is an openness to exploring external opportunities for M&A, although the focus remains on internal capabilities and collaborations [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the alignment with government goals regarding drug pricing and innovation, emphasizing the importance of fostering a supportive environment for the industry [9] - The company is optimistic about the future growth of its products, particularly with the enhancements to Eylea and the ongoing success of Dupixent [22][30] Other Important Information - The company is awaiting the first round of Part B IRA drug selections, which could impact Eylea's market position [26][28] - Linvoseltamab is showing promising results in a crowded myeloma market, with best-in-class data among BCMA bispecifics [62] Q&A Session Summary Question: Update on manufacturing and policy context - The company has committed to expanding domestic manufacturing and is in active negotiations regarding drug pricing with the administration [6][7] Question: Future M&A considerations - The company is open to external opportunities but prioritizes internal investments and collaborations [12][13] Question: Eylea HD commercial impact - Eylea HD enhancements are expected to have a significant impact starting in 2026, with ongoing efforts to convert patients from Eylea 2 mg to Eylea HD [21][22] Question: Competition from biosimilars - Biosimilars present challenges, but Eylea HD is positioned as a strong competitor with unique advantages [24] Question: Growth drivers for Dupixent - Dupixent continues to grow due to its market-leading position and under-penetrated opportunities in atopic dermatitis and asthma [30][31] Question: COPD launch and patient adoption - The COPD launch has been successful, with significant patient adoption and positive feedback on efficacy [33][34] Question: Future pipeline developments - The company is focused on advancing its pipeline, including LAG-3 and Linvoseltamab, with promising data expected in the near future [40][62]

Financial Data and Key Metrics Changes - The company announced a $7 billion commitment to expand R&D capabilities and domestic manufacturing, indicating a strong focus on internal growth and innovation [6][8] - The company has a substantial cash balance and has initiated dividends and buybacks, but historically has not engaged in significant M&A activity [10][12] Business Line Data and Key Metrics Changes - Eylea received recent approvals for RVO and Q4 dosing, with expectations for commercial impact starting in 2026 [17][18] - Dupixent is actively treating over 1.3 million patients globally, with significant growth potential in atopic dermatitis and asthma markets [30][31] - Linvoseltamab has shown best-in-class data among BCMA bispecifics, with response rates around 70% and complete response rates around 50% [63] Market Data and Key Metrics Changes - The company is expanding its manufacturing capabilities in the U.S. to meet growing pipeline demands, including a fill-finish facility to diversify supply chain risks [6][7] - The company is closely monitoring the impact of biosimilars on Eylea, particularly in the context of competition from products like Vabysmo [22][23] Company Strategy and Development Direction - The company is committed to investing in internal capabilities while remaining open to external opportunities for M&A, focusing on late-stage opportunities with high revenue potential [11][12] - The strategy includes enhancing the Eylea brand through new product enhancements and addressing patient affordability issues [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term shareholder value driven by investments in the pipeline and domestic manufacturing [6][9] - The company is aligned with government goals regarding drug pricing and innovation, indicating a proactive approach to policy changes [8][9] Other Important Information - The company is awaiting the first round of Part B IRA drug selections, which could impact Eylea's market position [25][27] - Upcoming data presentations from ongoing studies, including those for Linvoseltamab and LAG-3, are anticipated to provide insights into future growth opportunities [66][71] Q&A Session Summary Question: What is the company's approach to M&A and external opportunities? - The company is open to exploring external opportunities for M&A, focusing on late-stage opportunities that align with their internal capabilities and scientific rigor [11][12] Question: How does the company plan to address competition from biosimilars? - The company believes that Eylea HD's differentiated profile and dosing flexibility will help it compete effectively against biosimilars [23][24] Question: What are the growth drivers for Dupixent moving forward? - Dupixent continues to benefit from market expansion in atopic dermatitis and asthma, with significant room for growth due to low penetration rates [30][31] Question: What is the outlook for Linvoseltamab in the myeloma market? - Linvoseltamab has shown compelling efficacy and safety data, positioning it well in a competitive myeloma landscape [63][64] Question: How is the company preparing for upcoming regulatory decisions? - The company is actively preparing for FDA submissions and anticipates positive outcomes from ongoing studies, which will inform future strategies [42][66]

Core Insights - Regeneron Pharmaceuticals has entered a collaboration agreement with Tessera Therapeutics to jointly develop TSRA-196, a gene editing therapy for Alpha-1 Antitrypsin Deficiency (AATD) [1][3][4] - AATD is a genetic disorder affecting approximately 200,000 individuals in the U.S. and Europe [1] Collaboration Details - The collaboration will leverage Regeneron's expertise in genetics and clinical development alongside Tessera's Gene Writing and non-viral delivery platforms [3] - Regeneron will provide Tessera with $150 million, which includes an upfront cash payment and equity investment, plus up to $125 million in milestone payments [4] - Tessera will conduct the initial clinical trial, after which Regeneron will take over global development and commercialization [4] Clinical Development - Tessera plans to file an investigational new drug application and multiple clinical trial applications for TSRA-196 with the FDA by the end of this year [5] - Preclinical data presented by Tessera indicates effective genome editing of the SERPINA1 locus in animal models, supporting the advancement of TSRA-196 into clinical development [5][8] Financial Performance - Regeneron stock has increased by 5.3% year-to-date, while the industry has seen a growth of 20.3% [2] - The company has faced challenges with its lead drug Eylea due to competition, prompting the development of a higher dose formulation, Eylea HD [10][12] - Regeneron's revenue is also supported by its share of profits from Dupixent, which continues to perform well despite the decline in Eylea sales [13]