TARRYTOWN, N.Y. and WASHINGTON, D.C., May 17, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Society for Science (the Society) announced that Grace Sun, 16, of Lexington, Kentucky, won the $75,000 top award, the George D. Yancopoulos Innovator Award, named in honor of the pioneering drug researcher and Regeneron co-Founder, Board co-Chair, President and Chief Scientific Officer, in the 2024 Regeneron International Science and Engineering Fair (Regeneron ISEF), the world's largest ...

TARRYTOWN, N.Y. and WASHINGTON, D.C., May 17, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Society for Science (the Society) announced that Grace Sun, 16, of Lexington, Kentucky, won the $75,000 top award, the George D. Yancopoulos Innovator Award, named in honor of the pioneering drug researcher and Regeneron co-Founder, Board co-Chair, President and Chief Scientific Officer, in the 2024 Regeneron International Science and Engineering Fair (Regeneron ISEF), the world’s larges ...

Regeneron Pharmaceuticals Inc (NASDAQ:REGN) RBC Capital Markets Global Healthcare Conference May 14, 2024 9:00 AM ET Company Participants Ryan Crowe - Senior Vice President of Investor Relations & Strategic Analysis Chris Fenimore - Senior VP of Finance & CFO Conference Call Participants Brian Abrahams - RBC Brian Abrahams All right. Let's get started. Welcome, everyone. I'm Brian Abrahams, senior biotech analyst here at RBC Capital Markets. Really pleased to have Regeneron here, represented by the CFO, Chr ...

If approved, Dupixent would be the first treatment in the U.S. indicated for adolescents aged 12-17 years with inadequately controlled CRSwNP, a condition driven in part by underlying type 2 inflammation that obstructs the sinuses and nasal passages and can lead to a loss of sense of smell Current treatment options for adolescents with CRSwNP leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps TARRYTOWN, N.Y. and PARIS, May 13, 2024 (GLOBE NEWSWIRE) -- Regeneron ...

Preliminary data detailed in an ASGCT oral presentation include results for one of the youngest children in the world to receive a gene therapy for genetic deafness Ongoing Phase 1/2 CHORD trial is currently enrolling infants and children in the U.S., UK and Spain TARRYTOWN, N.Y., May 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced that the investigational gene therapy DB-OTO improved hearing to normal levels in one child (dosed at 11 months of age) within 24 weeks ...

Financial Data and Key Metrics Changes - First quarter 2024 revenues increased by 7% year-over-year to $3.1 billion, excluding last year's COVID antibody contributions [10][42] - Diluted net income per share was $9.55, with net income of $1.1 billion [42] - Gross margin on net product sales was approximately 89%, impacted by startup costs for the fill/finish manufacturing facility [45] Business Line Data and Key Metrics Changes - Dupixent global net product sales reached $3.1 billion, up 24%, with strong growth across all approved indications [10][37] - Libtayo global net sales were $264 million, up 44% on a constant currency basis, driven by skin and lung cancer markets [41] - EYLEA HD generated $200 million in its second full quarter on the U.S. market, with a 63% sequential growth [34] Market Data and Key Metrics Changes - EYLEA and EYLEA HD combined U.S. net sales were $1.4 billion, securing 45% of the anti-VEGF category share [35] - Dupixent leads in new-to-brand prescription share across all five FDA approved indications [37] - Approximately 300,000 patients in the U.S. with uncontrolled COPD show evidence of Type 2 inflammation, representing a significant market opportunity if Dupixent is approved for this indication [39] Company Strategy and Development Direction - The company is focused on expanding its pipeline with over 35 programs in clinical development across various therapeutic areas [17] - Regeneron aims to position EYLEA HD as the new standard of care for retinal diseases, leveraging direct-to-consumer marketing strategies [36] - The company is preparing for the potential launch of Dupixent in COPD, emphasizing education and alignment with reimbursement strategies [88] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Dupixent, particularly with potential new indications [40] - The company anticipates significant growth opportunities in the COPD market, with a focus on addressing unmet patient needs [39] - Management highlighted the importance of maintaining a strong pipeline and executing well in competitive categories [17] Other Important Information - Regeneron announced a new $3 billion share repurchase program, enhancing its capital return strategy [46] - The company expects R&D expenses for 2024 to be in the range of $4.4 billion to $4.6 billion, reflecting ongoing investments in its pipeline [47] Q&A Session Summary Question: Can you discuss the differentiation of your muscle-sparing obesity program compared to competitors? - Management highlighted that their program targets specific members of the BMP, GDF family involved in muscle preservation, aiming for a better safety profile compared to broader approaches [50] Question: What endpoints do you think the FDA would accept for muscle-sparing approaches in obesity? - Management indicated that while weight loss might be the simplest regulatory endpoint, they would also consider metabolic parameters and functional outcomes as the program evolves [54] Question: How do you see the recent consolidation in the retina market affecting your go-to-market strategy? - Management noted that the inventory drawdown was market-wide and emphasized their effective commercialization approach to adapt to market changes [59] Question: Could you elaborate on the potential for restrictions to specific subpopulations in the COPD program? - Management expressed confidence that the data supports broad approval for Dupixent in eosinophilic COPD, with ongoing analyses to ensure comprehensive understanding [62] Question: What are your thoughts on the linvoseltamab launch as you approach the August PDUFA? - Management is preparing for the potential launch, emphasizing the product's best-in-class potential for late-stage myeloma patients [96]

Regeneron Pharmaceuticals, Inc. (REGN) delivered lower-than-expected first-quarter 2024 results due to declining sales of its lead drug, Eylea (aflibercept).  The company reported earnings per share (EPS) of $9.55, which missed the Zacks Consensus Estimate of $10.20. The company recorded EPS of $10.09 in the year-ago period.Higher expenses and lower revenues adversely impacted the bottom line.Total revenues declined 1% year over year to $3.14 billion, which also missed the Zacks Consensus Estimate of $3.19 ...

For the quarter ended March 2024, Regeneron (REGN) reported revenue of $3.15 billion, down 0.5% over the same period last year. EPS came in at $9.55, compared to $10.09 in the year-ago quarter.The reported revenue represents a surprise of -1.53% over the Zacks Consensus Estimate of $3.19 billion. With the consensus EPS estimate being $10.20, the EPS surprise was -6.37%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expe ...

Regeneron C or porat e P res ent at ion M A Y 2 0 2 4 This non-promotional presentation contains investigational data as well as forward-looking statements; actual results may vary materially. Note regarding forward-looking statements and non-GAAP financial measures Thispresentationincludesforward-lookingstatementsthatinvolverisksanduncertaintiesrelatingtofutureeventsandthefutureperformanceofRegeneronPharmaceuticals,Inc.("Regeneron"orthe"Company"),andactualeventsor resultsmaydiffermateriallyfromtheseforward ...

Financial Performance - Regeneron reported revenues of $3,145.0 million for the three months ended March 31, 2024, a decrease of 0.5% from $3,162.1 million in the same period of 2023[105]. - Net income for the quarter was $722.0 million, down 11.7% from $817.8 million year-over-year[105]. - Diluted net income per share decreased to $6.27, compared to $7.17 in the prior year, reflecting a decline of 12.5%[105]. - Revenues for the three months ended March 31, 2024, were $3,145.0 million, a decrease of 0.5% from $3,162.1 million in the same period of 2023[140]. - Net product sales for EYLEA in the U.S. decreased to $1,401.6 million, down 32.2% from $1,433.8 million year-over-year[142]. - Collaboration revenue from Sanofi increased to $909.8 million, up 13.9% from $798.4 million in the prior year[144]. - Regeneron's share of profits from Dupixent and Kevzara net product sales was $925.9 million, an increase of 30.1% from $711.4 million year-over-year[147]. - Total operating expenses for the three months ended March 31, 2024, were $2,393.6 million, an increase of 8.0% from $2,215.4 million in the same period of 2023[151]. - Cash flows provided by operating activities were $1,512.5 million for the three months ended March 31, 2024, an increase of $144.9 million from $1,367.6 million in the same period of 2023[165]. - Cash flows used in investing activities significantly increased to $(1,687.1) million in Q1 2024, compared to $(235.7) million in Q1 2023, indicating a change of $(1,451.4) million[165]. - As of March 31, 2024, the company had cash and cash equivalents of $2,602.0 million, down from $2,730.0 million at the end of 2023, a decrease of $128.0 million[164]. - The company reported unrealized losses on equity securities of $(196.2) million for Q1 2024, compared to $(164.7) million in Q1 2023[159]. - The effective tax rate for the three months ended March 31, 2024, was (3.0%), compared to 4.7% in the same period of 2023, positively impacted by stock-based compensation and income earned in lower-tax jurisdictions[161]. Product Development and Pipeline - The company continues to focus on developing treatments for serious diseases, including eye diseases, cancer, and rare diseases, leveraging its integrated biotechnology capabilities[104]. - Regeneron emphasizes the importance of maintaining a strong foundation in scientific research and discovery-enabling technologies to support its product pipeline[104]. - The company is actively pursuing regulatory approvals for its late-stage product candidates, which may impact future revenue streams[105]. - The company plans to initiate a Phase 3 study for EYLEA HD in RVO by mid-2024 and submit a supplemental Biologics License Application for wAMD and DME[116]. - Dupixent has received FDA approval for EoE in pediatrics, with an EC decision on regulatory submission expected in the second half of 2024[116]. - The company anticipates a decision from the FDA on the sBLA for Dupixent by June 27, 2024, and an EC decision for COPD regulatory submission in the second half of 2024[117]. - Upcoming milestones include reporting results from ongoing Phase 3 trials in CSU and bullous pemphigoid in late 2024[117]. - The company is developing multiple product candidates in clinical phases, with uncertainties related to safety, efficacy, and regulatory requirements impacting timelines[113]. - The company initiated a Phase 1 study of linvoseltamab in combination with dupilumab for severe food allergy in 2024[123]. - The company is expected to report results from the Phase 2 study of REGN9933 in thrombosis in the second half of 2024[119]. - The company plans to report initial data from the Phase 2/3 study in first-line advanced NSCLC in the second half of 2024[118]. - The company has a target action date of August 22, 2024, for the FDA decision on the BLA for relapsed/refractory multiple myeloma[118]. - The company will present updated data from the Phase 1/2 trial of DB-OTO at the May 2024 ASGCT annual conference[123]. - The company has expanded its collaboration with Intellia to develop additional in vivo CRISPR-based gene editing therapies[132]. Collaborations and Partnerships - Regeneron collaborates with Bayer and Sanofi for various products, which may influence market expansion and product availability[109]. - The company has a contingent reimbursement obligation to Sanofi of approximately $2.200 billion as of March 31, 2024, related to development expenses[124]. - The company authorized a new share repurchase program in April 2024 to repurchase up to an additional $3.0 billion of its common stock, with $1.233 billion remaining available under the previous program as of March 31, 2024[169]. - Collaboration revenue from Bayer was $356.0 million, slightly down from $356.9 million in the prior year[148]. - Regeneron's share of profits in connection with commercialization of antibodies increased to $804.0 million, up 26.3% from $636.5 million year-over-year[144]. Operational and Regulatory Considerations - Ongoing regulatory obligations and potential delays from governmental authorities could affect the commercialization of Regeneron's products[105]. - The company is focused on managing supply chains effectively to ensure the availability of its products in the market[105]. - Total direct research and development expenses for the three months ended March 31, 2024, were $408.3 million, an increase of 85.9 million or 26.7% compared to $322.4 million in the same period of 2023[154]. - Total research and development expenses, including stock-based compensation, amounted to $1,248.4 million for the three months ended March 31, 2024, up from $1,101.2 million in 2023, reflecting an increase of $147.2 million or 13.4%[154]. - Selling, general, and administrative expenses increased due to commercialization-related expenses for EYLEA HD and higher headcount costs, totaling $86.2 million in stock-based compensation for Q1 2024, compared to $76.8 million in Q1 2023[155]. - The company conducted an evaluation of its disclosure controls and procedures, concluding they were effective as of the end of the reporting period[175]. - There were no changes in internal control over financial reporting during the quarter ended March 31, 2024, that materially affected or are likely to affect internal controls[176]. - The company referenced its market risks and management strategies in its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, with no material changes noted as of March 31, 2024[173].