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 ...

Core Viewpoint - Regeneron Pharmaceuticals (REGN) stock is considered a value investment opportunity as it is trading nearly 38% lower than its one-year peak and at a price to sales multiple below the average of the past three years, while maintaining reasonable fundamentals for its current valuation [1][7]. Company Overview - Regeneron Pharmaceuticals develops innovative medicines globally, focusing on therapies for eye diseases, atopic dermatitis, asthma, and rheumatoid arthritis through discovery, development, manufacturing, and commercialization processes [4]. Product Pipeline and Market Position - The company's core approved medicines, such as Dupixent and Eylea, hold strong market positions. Dupixent is an anti-inflammatory therapy for eczema, asthma, and other allergic conditions, while Eylea is a leading treatment for macular degeneration and diabetic eye disease. Regeneron's pipeline includes multiple therapeutic areas like oncology, rare diseases, immunology, and allergies, with several drugs in late-stage trials indicating significant future growth potential [3][4]. Financial Performance - Regeneron has shown reasonable revenue growth of 5.4% over the last twelve months and an average of 0.3% over the past three years. The company has a free cash flow margin of approximately 25.0% and an operating margin of 27.0% for the last twelve months. There have been no major margin shocks in the past year, and REGN stock is trading at a modest PE multiple of 13.6, which is lower compared to the S&P [7]. Competitive Advantage - Compared to the S&P, Regeneron presents a lower valuation, higher revenue growth, and superior margins, indicating a competitive advantage in the market [7].

Summary of Key Points from the Conference Call on China's Healthcare Industry and Emerging Oral GLP-1 Pipelines Industry Overview - The report focuses on the **emerging oral GLP-1 pipeline** within the **China healthcare industry** and discusses the potential market size exceeding **$45 billion** [1][8][14]. Core Insights and Arguments - The global oral GLP-1 market is projected to peak between **$45 billion and $75 billion**. Recent clinical data from leading companies indicate that emerging pipelines still have opportunities for market entry [8][14]. - Over **20 oral GLP-1 candidates** from Chinese biopharmaceutical companies are in development, with most retaining global rights. This suggests significant potential for future licensing and partnerships [8][18]. - Companies such as **Hengrui/Kailera**, **Huadong Medicine**, and **Regor Therapeutics** are leading in clinical progress and data maturity, with several key catalytic events expected in the next six months [8][18]. - The emerging pipeline is diverse, including candidates from **Hansoh Pharmaceutical**, **China Biologic Products**, **Sino Biopharma**, and several private companies [8][18]. - Variations in patient baseline characteristics and dose escalation strategies complicate direct data comparisons across clinical trials. Other critical factors include data integrity for indications beyond obesity, scalability of production, and patent reviews [8][18]. Additional Important Insights - The oral GLP-1 market is evolving towards a more fragmented competitive landscape, contrary to the previously expected oligopolistic structure. Recent clinical results from leading candidates suggest new entry opportunities for emerging pipelines [15][18]. - The report outlines the competitive landscape and potential collaboration opportunities, highlighting that the U.S. biopharma sector is actively seeking partnerships with Chinese companies due to the evolving market dynamics [18][20]. - The report includes a detailed table of oral GLP-1 candidates, their development phases, and licensing status, providing a comprehensive overview of the competitive landscape [3][20]. Conclusion - The oral GLP-1 market presents a significant opportunity for both established and emerging players, particularly from China. The evolving clinical data and competitive dynamics suggest a promising future for innovative therapies in this space [8][14][15].

​Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the Most Undervalued Long Term Stocks to Buy Right Now. On October 17, Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced that the European Medicines Agency adopted a positive opinion for its Libtayo, which treats adults with cutaneous squamous cell carcinoma. Earlier this month, Libtayo was approved by the FDA to treat patients with cutaneous squamous cell carcinoma who are at high risk of recurrence after surgery and radiation. Management exp ...

Core Insights - Longleaf Partners Fund reported a return of -0.33% in Q3 2025, underperforming the S&P 500's 8.12% and the Russell 1000 Value's 5.33% [1] - The fund focuses on investments in real assets and brands that generate growing free cash flow (FCF) per share, with an expectation that the FCF multiple could rise from ~10x to the mid-teens [1] Fund Performance - The fund's performance in Q3 2025 was disappointing, with a return of -0.33% compared to significant gains in broader indices [1] - The firm is implementing strategies to improve margins and increase share repurchases to enhance future performance [1] Regeneron Pharmaceuticals, Inc. Insights - Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) had a one-month return of 3.19% but experienced a significant decline of 37.64% over the past 52 weeks, closing at $575.69 per share with a market cap of $61.316 billion on October 23, 2025 [2] - The fund views Regeneron as having regained value per share and highlights its strong pipeline candidates and share repurchase activity [3] Market Position and Revenue - Regeneron Pharmaceuticals, Inc. was held by 73 hedge fund portfolios at the end of Q2 2025, an increase from 66 in the previous quarter [4] - The company reported total revenues of $3.7 billion in Q2 2025, reflecting a 4% growth year-over-year [4]

Core Insights - Investors are focusing on profits from asthma drug Dupixent and sales of Eylea HD as Regeneron Pharmaceuticals prepares to report its third-quarter 2025 results on October 28, 2025, with revenue estimates at $3.60 billion and earnings at $9.54 per share [1] Financial Performance - Regeneron has a history of earnings surprises, beating estimates in three of the last four quarters with an average surprise of 16.99%, including a 60.52% beat in the last reported quarter [2] - The Earnings ESP for Regeneron is -0.63%, indicating a potential earnings miss, with the Zacks Consensus Estimate at $9.54 per share and the Most Accurate Estimate at $9.48 [4] Product Sales - Eylea, a significant revenue source for Regeneron, has faced declining sales due to competition from Vabysmo, with U.S. sales estimated at $686 million for Q3 [6] - Eylea HD, a higher dose version, is expected to see strong sales, estimated at $414 million, potentially offsetting declines in Eylea sales [7] - Dupixent sales are projected to rise by 26.2% in Q3, driven by strong demand across multiple approved indications, contributing to Regeneron's profits [9] Oncology Franchise - Regeneron is diversifying its revenue base to reduce dependence on Eylea, with growth in its oncology franchise driven by Libtayo and the newly approved Lynozyfic [10][12] - Libtayo sales are estimated at $370 million, benefiting from increased demand for non-melanoma skin indications [11] Operating Expenses and Share Buybacks - Operating expenses are likely to have increased due to pipeline advancements and commercialization efforts for Eylea HD [13] - A decrease in outstanding shares from a $3.0 billion share repurchase program may positively impact the bottom line [14] Regulatory Updates - Investors will be looking for updates on key pipeline and regulatory developments, including the recent FDA approval for Libtayo's label expansion [15] Stock Performance - Regeneron's shares have declined by 18.8% year-to-date, contrasting with the industry's growth of 11.1% [16]

Core Insights - Analysts project Regeneron (REGN) will report quarterly earnings of $9.54 per share, reflecting a year-over-year decline of 23.4% [1] - Revenue is expected to reach $3.6 billion, down 3.3% from the same quarter last year [1] Earnings Estimates - The consensus EPS estimate has been revised downward by 2% over the past 30 days, indicating a collective reassessment by analysts [2] - Revisions to earnings estimates are significant indicators for predicting investor actions regarding the stock [3] Revenue Projections - Analysts estimate 'Revenues- Libtayo- Total' at $370.10 million, a year-over-year increase of 28.2% [5] - 'Revenues- Other Revenue' is projected at $131.84 million, reflecting a 15.5% increase from the previous year [5] - 'Revenues- Net product sales' are expected to be $1.57 billion, showing a decline of 19.3% year over year [5] Specific Product Revenues - 'Revenues- Collaboration' is estimated at $1.85 billion, indicating an 11.6% year-over-year increase [6] - 'Revenues- Eylea (Aflibercept)- US' is projected at $1.09 billion, down 28.9% from the year-ago quarter [6] - 'Revenues- Dupixent (dupilumab)- US' is expected to reach $3.40 billion, reflecting a 20.4% increase year over year [8] Market Performance - Over the past month, Regeneron shares have returned +1.3%, outperforming the Zacks S&P 500 composite's +0.2% change [8] - Currently, REGN holds a Zacks Rank 3 (Hold), suggesting its performance may align with the overall market in the near future [9]

Core Opinion - Regeneron Pharmaceuticals received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for Libtayo as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation [1][2] Clinical Trial Results - The Phase 3 C-POST trial demonstrated that Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo, with a hazard ratio of 0.32 and a p-value of less than 0.0001 [1][2] - In the trial, locoregional or distant recurrence rates were lower in the Libtayo group (4% vs. 17% for locoregional and 5% vs. 13% for distant recurrence) compared to placebo [2] Safety Profile - The safety profile of Libtayo in this trial was consistent with its known safety profile in advanced cancers, with adverse events occurring in 91% of patients receiving Libtayo and 89% in the placebo group [3] - Grade ≥3 adverse events were reported in 24% of the Libtayo group compared to 14% in the placebo group, with hypertension being the only grade ≥3 adverse event occurring in more than 2% of patients in the Libtayo arm [3] Trial Design - The C-POST trial was a randomized, placebo-controlled, double-blind, multicenter global study involving 415 patients at high risk of CSCC recurrence [4][5] - Participants received either Libtayo or placebo for up to 48 weeks, with specific dosing regimens outlined [5] About CSCC - Cutaneous squamous cell carcinoma (CSCC) is a common type of non-melanoma skin cancer, with a projected 40% increase in incidence in the EU by 2040 [6] Regeneron's Commitment to Cancer Treatment - Regeneron aims to develop transformative medicines for cancer, leveraging scientific innovation and a deep understanding of biology and genetics [7][8] - The company has a robust pipeline focused on various solid tumors and blood cancers, with Libtayo being a key asset [8][27]

Core Insights - Regeneron Pharmaceuticals, Inc. (REGN) announced updated data on its investigational gene therapy DB-OTO from the CHORD study, which targets profound genetic hearing loss due to variants of the otoferlin (OTOF) gene [1][9] - The latest data was presented at the annual American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNSF) meeting and published in The New England Journal of Medicine [1] Gene Therapy Details - DB-OTO is a cell-selective, dual adeno-associated virus (AAV) vector gene therapy designed to provide durable hearing to individuals with profound, congenital hearing loss caused by OTOF gene variants [2] - The CHORD study is a registrational phase I/II multicenter, open-label study evaluating the safety, tolerability, and efficacy of DB-OTO in infants, children, and adolescents with OTOF-related hearing loss [3] Study Design and Results - The study consists of two parts: Part A involves a single intracochlear infusion of DB-OTO in one ear, while Part B involves administration in both ears at the selected dose from Part A [4] - Results showed that 11 out of 12 participants experienced clinically meaningful hearing improvements, with three achieving normal hearing levels [5][9] - Among the three participants who completed speech assessments, all showed substantial improvement [6] Long-term Efficacy and Tolerability - Hearing improvements remained stable or continued to improve in eight participants with follow-up visits of 36 weeks or more [7] - Both the surgical procedure and DB-OTO were well tolerated across all participants [7] Regulatory Status and Future Plans - DB-OTO has received multiple designations from the FDA, including Orphan Drug and Fast Track status, and the European Medicines Agency granted Orphan Drug Designation [7] - REGN plans to submit regulatory filings for DB-OTO in the United States later this year, pending discussions with the FDA [8] Portfolio Diversification Efforts - REGN is diversifying its portfolio as its lead drug Eylea faces competition from Roche's Vabysmo, which has seen significant uptake [10] - Eylea HD sales surged 29% in the second quarter due to increased demand [13] - The company's oncology franchise has been bolstered by recent FDA approvals for Libtayo and linvoseltamab-gcpt [15][16]

Core Insights - Regeneron Pharmaceuticals announced new data from the Phase 3 C-POST trial for Libtayo (cemiplimab), focusing on a patient-centric every 6-week dosing regimen for high-risk cutaneous squamous cell carcinoma (CSCC) [1][2] Group 1: Clinical Data and Trial Results - The C-POST trial data will be presented at the ESMO 2025 Meeting, highlighting the efficacy and safety of Libtayo as an adjuvant treatment for CSCC [1][2] - Patients in the trial initially received 350 mg of Libtayo every 3 weeks for 12 weeks, with most switching to every 6-week dosing thereafter, while the safety profile remained consistent with previous findings [2] Group 2: Regulatory and Approval Status - The new data supports the FDA approval of Libtayo as the first immunotherapy for adjuvant treatment of adult patients with high-risk CSCC following surgery and radiation [2] Group 3: Company Overview and Pipeline - Regeneron is focused on developing therapies for over 30 types of solid tumors and blood cancers, with nearly half of its pipeline dedicated to oncology assets [6][26] - Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint, approved in over 30 countries for various indications, including advanced CSCC and non-small cell lung cancer [8][9]