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]

Core Viewpoint - Regeneron and Johnson & Johnson face challenges in the early intervention field for smoldering multiple myeloma (SMM), despite promising new data. The adoption of Regeneron's Lynozyfic and Johnson's Darzalex may be slow due to the need for physicians to balance the risks of overtreatment with the difficulty in identifying high-risk patients who may benefit [3][4]. Group 1: Regeneron's Lynozyfic - Lynozyfic shows a total response rate (ORR) of 100% and a complete response rate (CR) of 36.8% for high-risk SMM, but these rates may not be as significant for active myeloma. The key measure of success is whether the drug can delay disease progression and improve survival [4][5]. - The safety profile of Lynozyfic raises concerns, with a 12.5% incidence of grade 3-4 infections and a 25% incidence of grade 3-4 neutropenia, alongside a 42% occurrence of any grade cytokine release syndrome [4][5]. Group 2: Johnson & Johnson's Darzalex - The AQUILA trial indicates that Darzalex monotherapy extends progression-free survival (PFS) and overall survival (OS) for high-risk SMM patients, reducing disease progression rates from 41.8% in the observation group to 21.8%. This has led to EU approval and potential FDA approval [8]. - There are concerns regarding the definition of "high-risk" SMM in the AQUILA trial compared to existing SLiM standards, which may hinder the widespread application of Darzalex due to the asymptomatic nature of the disease [8]. Group 3: Patient Identification and Treatment Concerns - The Quiredex trial shows that lenalidomide combined with dexamethasone significantly delays the progression to multiple myeloma, with a PFS of 9.5 years compared to 2.1 years for the control group. However, many physicians remain cautious about early intervention due to overtreatment risks and challenges in accurately identifying high-risk patients [6][8]. - The use of circulating tumor DNA (ctDNA) detection technology is suggested to better identify patients at high risk of progressing to multiple myeloma, aiming to minimize overtreatment [6].

Core Insights - Regeneron Pharmaceuticals, Inc. is a biotechnology company focused on developing medicines for serious diseases, with a market cap of $59.1 billion, and is set to announce its fiscal Q3 earnings for 2025 on October 28 [1] Financial Performance - Analysts expect Regeneron to report a profit of $7.80 per share for Q3 2025, a decrease of 33.5% from $11.73 per share in the same quarter last year [2] - For fiscal 2025, the expected profit is $32.36 per share, down 16.2% from $38.62 per share in fiscal 2024, with a further decline of 2.4% anticipated for fiscal 2026 [3] Stock Performance - Regeneron's stock has declined 44.9% over the past 52 weeks, underperforming compared to the S&P 500 Index's 12.3% return and the Health Care Select Sector SPDR Fund's 8.6% drop [4] - Following a better-than-expected Q2 earnings release, Regeneron's shares surged 2.5%, with overall revenue improving 3.6% year-over-year to $3.7 billion, exceeding analyst expectations by 10.2% [5] Analyst Ratings - Wall Street analysts maintain a "Moderate Buy" rating for Regeneron, with 18 out of 27 analysts recommending "Strong Buy," and a mean price target of $729.85, indicating a potential upside of 29.5% from current levels [6]

Core Viewpoint - Investing in companies that have underperformed but show potential for long-term recovery can yield above-average market returns, exemplified by DexCom and Regeneron Pharmaceuticals, whose shares are down 17% and 21% this year respectively due to company-specific challenges [1]. DexCom - DexCom specializes in continuous glucose monitoring (CGM) systems for diabetes patients, facing challenges such as worse-than-expected financial results and a faster-than-anticipated rebate eligibility impacting revenue [3][4]. - In Q2, DexCom's revenue increased by 15% year-over-year to $1.2 billion, with non-GAAP net earnings per share at $0.48, reflecting an 11.6% increase compared to the previous year, indicating a rebound in financial performance [4]. - The CGM market presents significant growth opportunities, with over 4.5 million insulin patients in the U.S. eligible for coverage but not yet using CGM, and the launch of Stelo as an over-the-counter option for non-insulin patients further expands market potential [6][7]. - DexCom benefits from a network effect due to its large installed base and integration with third-party devices, which could help mitigate tariff threats through a multipronged strategy [7][8]. Regeneron Pharmaceuticals - Regeneron is working to overcome a recent patent cliff, indicating potential for future growth and recovery in its stock performance [8].

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] Group 1: DB-OTO Gene Therapy - 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, currently enrolling participants under 18 years across the U.S., U.K., Spain, and Germany [3] - The study consists of two parts: Part A involves a single intracochlear infusion of DB-OTO in one ear, while Part B involves administering DB-OTO in both ears at the selected dose from Part A [4] Group 2: Study Results - Out of 12 participants aged 10 months to 16 years, 11 experienced clinically meaningful hearing improvements, with three achieving normal hearing levels; eight participants with longer follow-up showed stability or continued improvement in hearing [5][7] - Among three participants who completed speech assessments, all showed substantial improvement, with one able to identify one- and two-syllable words without visual cues [6] - The trial met its primary endpoint, with nine participants showing hearing improvements at a threshold of ≤70 decibel hearing level (dBHL) at week 24 [6] Group 3: Regulatory and Market Context - DB-OTO has received Orphan Drug, Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy designations from the FDA, with the European Medicines Agency also granting Orphan Drug Designation [7] - REGN plans to submit regulatory filings for DB-OTO in the U.S. later this year, pending discussions with the FDA [8] Group 4: Portfolio Diversification - 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, helping to counter the decline in Eylea sales [13] - The company's oncology franchise has been bolstered by recent FDA approvals for Libtayo and linvoseltamab-gcpt, as well as Ordspono for treating certain types of lymphoma [15][16][17]

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the top stocks to buy in Michael Burry’s stock portfolio. On October 6, the company announced it is poised to incur an $83 million in-process research and development (IPR&D) charge. Regeneron Pharmaceuticals, Inc. (REGN) Prepares for $83M Charge Copyright: nexusplexus / 123RF Stock Photo The charge is related to an $80 million up-front payment made to Hansoh Pharmaceuticals Group Company Limited as part of a 2025 license agreement. In addition to ...