Key Takeaways Regeneron reported positive data from the CHORD study on its investigational gene therapy DB-OTO.DB-OTO improved hearing in 11 of 12 participants, with 3 achieving normal hearing levels.The therapy was well tolerated and met its primary endpoint; U.S. filings are planned later this year.Regeneron Pharmaceuticals, Inc. (REGN) announced updated data on its investigational gene therapy DB-OTO from the CHORD study.This gene therapy is being evaluated for profound genetic hearing loss due to varian ...

Core Insights - Regeneron Pharmaceuticals (REGN) shares have declined by 21.1% year-to-date, underperforming the industry growth of 5.2% and the S&P 500 Index [1][8] - The lead drug Eylea has faced significant sales pressure due to competition from Roche's Vabysmo, impacting investor sentiment [2][6] - Despite challenges, Regeneron's oncology portfolio shows promise with recent approvals and strong sales growth in certain products [8][14] Company Performance - Eylea, the primary revenue driver, has seen declining sales due to competition, although Eylea HD sales in the U.S. increased by 29% in Q2 2025 [5][6] - The FDA has extended the review periods for Eylea HD submissions to Q4 2025, causing further uncertainty [7][10] - Dupixent continues to perform well, contributing positively to Regeneron's top line, with recent label expansions expected to drive sales growth [12][13] Oncology Portfolio - Regeneron's oncology franchise, including Libtayo, has shown strong performance with sales of $661.6 million in the first half of 2025, up 18% year-over-year [14] - Recent FDA approvals for Lynozyfic and Ordspono enhance the oncology portfolio, although Ordspono faced a setback with a complete response letter from the FDA [16][17] - The company is actively expanding its oncology pipeline, which is expected to diversify revenue sources [25] Future Outlook - Regeneron is exploring opportunities in the obesity market through a licensing agreement with Hansoh Pharmaceuticals, which could enhance its clinical-stage portfolio [19] - The company is also developing investigational allergen-blocking antibodies, with positive results from phase III studies [20] - Current valuation metrics indicate that REGN shares are trading at a price/earnings ratio of 17.87X forward earnings, higher than the large-cap pharma industry average [21] Challenges - Pipeline setbacks, particularly related to the mixed results from late-stage studies on itepekimab, pose risks to the company's near-term outlook [26] - The transition from Eylea to Eylea HD is expected to take time, creating additional pressure on the stock [25][27]

Core Insights - Regeneron's performance has been lackluster in 2023, with Eylea sales under pressure, but the company achieved revenue growth in Q2, providing some relief to investors [1][2] Eylea Performance - Eylea, a key drug for Regeneron, has faced declining sales due to competition from Roche's Vabysmo, which has seen significant uptake [3][4] - Eylea HD sales in the U.S. increased by 29% in Q2, driven by higher sales volumes and demand [4] - Regulatory approvals for Eylea HD are expected to be delayed until August 2025 due to issues identified during an FDA site inspection [5] Dupixent Contributions - Dupixent sales have positively impacted Regeneron's top line, with the drug approved for multiple conditions, including atopic dermatitis and asthma [7][8] - Recent label expansions for Dupixent are expected to further boost sales, with strong demand trends noted [11] Oncology Portfolio Expansion - Regeneron is expanding its oncology portfolio, with Libtayo sales reaching $561.3 million in the first half of 2025, an 18% year-over-year increase [12] - The FDA has accepted a supplemental biologics license application for Libtayo, with a target action date in October 2025 [13] - Recent FDA approvals for linvoseltamab (Lynozyfic) and odronextamab (Ordspono) have strengthened the oncology franchise, although odronextamab faced a setback due to a complete response letter from the FDA [14][15] Future Outlook - The progress in the oncology portfolio and consistent label expansions for Dupixent are expected to support Regeneron's top-line growth [16][17] - Pipeline setbacks, particularly related to the studies on itepekimab for COPD, have raised concerns among investors [18]

Core Insights - Investors are focusing on profits from asthma drug Dupixent and sales of Eylea HD as Regeneron Pharmaceuticals prepares to report Q2 2025 results on August 1, 2025, with revenue estimates at $3.34 billion and earnings at $8.15 per share [1][9] Financial Performance - Regeneron has a history of earnings surprises, beating estimates in three of the last four quarters with an average surprise of 4.20%, although it missed by 2.49% in the last quarter [2] - The earnings ESP for Regeneron is +7.62%, indicating a potential earnings beat, supported by a Zacks Rank of 3 (Hold) [4][3] Product Sales - Eylea, a significant revenue source, has faced sales pressure due to competition from Vabysmo, with estimates for Q2 sales in the U.S. at $1 billion [5][6][7] - The introduction of Eylea HD has seen strong initial uptake, which may help offset the decline in legacy Eylea sales [7] - Dupixent is expected to drive growth, with sales estimates at $4.2 billion, bolstered by strong prescription trends across various indications [10][8] Pipeline and Regulatory Updates - Regeneron is diversifying its revenue base to reduce dependence on Eylea, with ongoing efforts to expand its oncology franchise, including Libtayo, which has sales estimates of $322 million [11][12] - Recent approvals for Dupixent and linvoseltamab-gcpt (Lynozyfic) enhance Regeneron's pipeline, with Lynozyfic receiving accelerated approval for treating relapsed or refractory multiple myeloma [16][17] Operating Expenses and Share Repurchase - Operating expenses are expected to rise due to pipeline advancements and commercialization efforts for Eylea HD [14] - A new share repurchase program of up to $3 billion was authorized, with $3.874 billion remaining available as of March 31, 2025 [15] Stock Performance - Regeneron's shares have declined by 20.5% year-to-date, contrasting with a 3.3% decline in the industry [18]

Core Viewpoint - Regeneron Pharmaceuticals, Inc. (REGN) has underperformed the medical sector and S&P 500 Index, with shares down 22.6% year to date, while the industry has grown by 0.6% [1][2]. Sales Performance - The decline in sales of the lead drug Eylea has significantly impacted the company's top-line growth, as Eylea accounts for a majority of REGN's sales [1][5]. - Eylea's sales have faced pressure due to competition from Roche's Vabysmo, which has seen strong uptake, and the emergence of biosimilars [4][9]. Pipeline Developments - Regeneron is attempting to diversify its revenue and develop its oncology franchise, but recent pipeline setbacks have negatively affected investor sentiment [3][9]. - The FDA accepted a supplemental biologics license application (sBLA) for Eylea HD, with a target action date of August 19, 2025, but a complete response letter (CRL) was issued for the pre-filled syringe of Eylea HD due to issues with a third-party supplier [6][7]. Dupixent and Oncology Focus - Dupixent has been a strong contributor to REGN's top line, with ongoing label expansions and solid sales trends [12][14]. - The oncology franchise includes Libtayo and odronextamab, with recent approvals and ongoing efforts to strengthen this segment, although there have been setbacks in the U.S. approval process for odronextamab [15][18][17]. New Ventures - Regeneron is exploring the obesity market through a licensing agreement for an obesity drug with Hansoh Pharmaceuticals, aiming to expand its clinical-stage obesity portfolio [19][20]. Valuation and Estimates - REGN shares are currently trading at a price/earnings ratio of 18.27X forward earnings, slightly below its historical mean but above the large-cap pharma industry's average of 15.04X [21]. - The bottom-line estimate for 2025 has decreased by $0.57 to $36.15 over the past 60 days, indicating a downward trend in earnings expectations [23].

Core Insights - Regeneron Pharmaceuticals, Inc. (REGN) received FDA approval for linvoseltamab-gcpt, branded as Lynozyfic, for treating relapsed or refractory multiple myeloma (MM) after at least four prior therapies [1][6][7] - Lynozyfic is a bispecific antibody that connects B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells, leading to T-cell activation and cancer cell destruction [2][5] - The approval was based on the LINKER-MM1 trial, which showed a 70% objective response rate and a 45% complete response rate, marking it as one of the most effective bispecific antibodies for this patient group [4][7] Regulatory Approval - Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody with a dosing schedule of every two weeks starting at week 14, and every four weeks if a very good partial response is achieved after 24 weeks of therapy [5][7] - The approval addresses a significant unmet need for patients with late-stage MM, who have limited treatment options [6] Market Context - MM is the second most common blood cancer, with over 36,000 new cases expected in the US by 2025 [5] - REGN's shares have declined by 22.9% year-to-date, contrasting with a 0.6% decline in the industry [2] Oncology Portfolio Development - The approval of Lynozyfic enhances REGN's oncology portfolio, which includes Libtayo for various cancers [9] - REGN is also pursuing the approval of odronextamab for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma, with a target action date for resubmission set for July 30, 2025 [10][11] Competitive Landscape - REGN faces challenges with its lead drug Eylea, which is experiencing declining sales due to competition from Roche's Vabysmo, impacting its market share [11][12]