Regeneron(REGN)

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Dupixent® (dupilumab) Late-Breaking Data from NOTUS Confirmatory Phase 3 COPD Trial Presented at ATS and Published in The New England Journal of Medicine
Newsfilter· 2024-05-20 18:15
NOTUS results confirm landmark data from the Phase 3 BOREAS trial and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD TARRYTOWN, N.Y. and PARIS, May 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: ...
More than $9 Million Awarded to High School Scientists and Engineers at the Regeneron International Science and Engineering Fair 2024
Newsfilter· 2024-05-17 17:45
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 ...
More than $9 Million Awarded to High School Scientists and Engineers at the Regeneron International Science and Engineering Fair 2024
globenewswire.com· 2024-05-17 17:45
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 (REGN) RBC Capital Markets Global Healthcare Conference (Transcript)
2024-05-14 16:42
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 ...
Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of Adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)
Newsfilter· 2024-05-13 05:00
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 ...
Latest DB-OTO Results Show Dramatically Improved Hearing to Normal Levels in a Child with Profound Genetic Deafness within 24 Weeks and Initial Hearing Improvements in a Second Child at 6 Weeks
Newsfilter· 2024-05-08 10:00
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 ...
Regeneron(REGN) - 2024 Q1 - Earnings Call Transcript
2024-05-02 16:28
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 (REGN) Q1 Earnings, Sales Miss on Lower Eylea Sales
Zacks Investment Research· 2024-05-02 15:06
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 ...
Regeneron (REGN) Reports Q1 Earnings: What Key Metrics Have to Say
Zacks Investment Research· 2024-05-02 14:36
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(REGN) - 2024 Q1 - Earnings Call Presentation
2024-05-02 12:29
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 ...