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Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for serious diseases, including eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases . The company operates in one business segment, encompassing all activities related to the discovery, development, and commercialization of these medicines . Regeneron's key products include EYLEA and Dupixent, which are critical to the company's revenue generation . The company also engages in collaborations with other pharmaceutical companies, such as Sanofi and Bayer, to develop and commercialize certain products .
- EYLEA - Treats various eye conditions and is a significant contributor to Regeneron's financial performance.
- Dupixent - Used for allergic and inflammatory diseases, playing a crucial role in the company's revenue generation.
- Collaborative Products - Developed and commercialized through partnerships with companies like Sanofi and Bayer, supporting Regeneron's revenue streams.
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Given the FDA's anticipated delay in approving linvoseltamab due to unresolved findings at a third-party manufacturer, how will this impact your timelines and strategies for bringing linvoseltamab to market, and what steps are you taking to mitigate these delays?
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With the DOJ investigation alleging violation of the False Claims Act related to EYLEA's marketing practices, can you provide clarity on potential impacts to your marketing strategies and whether this has affected prescriber behavior or market dynamics, as indicated by lower volumes and prices?
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Despite your strong balance sheet, you haven't made significant acquisitions to leverage your commercial presence, particularly in eye diseases; are there plans to pursue acquisitions of novel blockbuster therapies to bolster your pipeline and capitalize on existing synergies?
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Could you elaborate on the commercial opportunity for your Factor XI programs, specifically detailing how the distinct profiles of your two antibodies might position you competitively in the $20 billion direct oral anticoagulant market, and what are your future development plans in this space?
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Regarding DUPIXENT's potential in treating food allergies, can you quantify the target patient population and discuss how the benefit-risk profile of your approach might allow for broader application beyond the most severe cases?
Competitors mentioned in the company's latest 10K filing.
- Biocon Biologics Ltd: Competitor for EYLEA HD and EYLEA in the EU with Yesafili (aflibercept) .
- Novartis AG and Genentech/Roche: Competitors for EYLEA HD and EYLEA in the United States, EU, and Japan with Lucentis (ranibizumab injection) .
- Samsung Bioepis Co., Ltd. and Biogen Inc.: Competitors for EYLEA HD and EYLEA in the United States and EU with Byooviz (ranibizumab-nuna) .
- Xbrane Biopharma AB and Bausch + Lomb: Competitors for EYLEA HD and EYLEA in the EU with Ximluci (ranibizumab) .
- Formycon AG, Bioeq AG, Coherus BioSciences, Inc., and Teva Ltd.: Competitors for EYLEA HD and EYLEA in the United States and EU with Cimerli (ranibizumab-eqrn) .
- Genentech/Roche: Competitors for EYLEA HD and EYLEA in the United States with Susvimo (ranibizumab ocular implant) and Vabysmo (faricimab-svoa) in the United States, EU, and Japan .
- Novartis AG: Competitor for EYLEA HD and EYLEA in the United States, EU, and Japan with Beovu (brolucizumab) Injection .
- Allergan/AbbVie Inc.: Competitor for EYLEA HD and EYLEA in the United States and EU with Ozurdex (dexamethasone intravitreal implant) .
- Alimera Sciences, Inc.: Competitor for EYLEA HD and EYLEA in the United States and EU with Iluvien (fluocinolone acetonide intravitreal implant) .
- Pfizer Inc.: Competitor for Dupixent in the United States and EU with Eucrisa/Staquis (crisaborole) .
- Incyte Corporation: Competitor for Dupixent in the United States with Opzelura (ruxolitinib) .
- Eli Lilly and Company/Incyte Corporation: Competitors for Dupixent in the EU and Japan with Olumiant (baricitinib) .
- Pfizer: Competitor for Dupixent in the United States, EU, and Japan with Cibinqo (abrocitinib) .
- AbbVie: Competitor for Dupixent in the United States, EU, and Japan with Rinvoq (upadacitinib) .
- LEO Pharma Inc.: Competitor for Dupixent in the United States, EU, and Japan with Adbry/Adtralza (tralokinumab) .
- Almirall S.A.: Competitor for Dupixent in the EU with Ebglyss (lebrikizumab) .
- Japan Tobacco Inc./Torii Pharmaceutical Co., Ltd.: Competitors for Dupixent in Japan with Corectim (delgocitinib) .
- Maruho Co., Ltd./Chugai Pharmaceutical Co., Ltd.: Competitors for Dupixent in Japan with Mitchga (nemolizumab) .
- Roche/Novartis: Competitors for Dupixent in the United States, EU, and Japan with Xolair (omalizumab) .
- GlaxoSmithKline (GSK): Competitor for Dupixent in the United States, EU, and Japan with Nucala (mepolizumab) .
- Teva: Competitor for Dupixent in the United States and EU with Cinqair (reslizumab) .
- AstraZeneca: Competitor for Dupixent in the United States, EU, and Japan with Fasenra (benralizumab) .
- AstraZeneca/Amgen: Competitors for Dupixent in the United States, EU, and Japan with Tezspire (tezepelumab-ekko) .
- Merck & Co., Inc.: Competitor for Libtayo in the United States, EU, and Japan with Keytruda (pembrolizumab) .
- Bristol-Myers Squibb: Competitor for Libtayo in the United States, EU, and Japan with Opdivo (nivolumab) .
- Roche: Competitor for Libtayo in the United States, EU, and Japan with Tecentriq (atezolizumab) .
- AstraZeneca: Competitor for Libtayo in the United States, EU, and Japan with Imfinzi (durvalumab) .
- Pfizer/Merck KGaA: Competitors for Libtayo in the United States, EU, and Japan with Bavencio (avelumab) .
- GSK: Competitor for Libtayo in the United States and EU with Jemperli (dostarlimab) .
| Customer | Relationship | Segment | Details |
|---|---|---|---|
Besse Medical | Distributor (subsidiary of Cencora) that sells Regeneron's products to healthcare providers or pharmacies. | All | 51% of total gross product revenue in 2023, 55% in 2022, 30% in 2021. |
McKesson | Distributor that delivers Regeneron's products to healthcare providers or pharmacies. | All | 25% of total gross product revenue in 2023, 28% in 2022, 18% in 2021. |
U.S. Government | Agreements for the manufacture and delivery of REGEN-COV for COVID-19 response. | All | 43% of total gross product revenue in 2021, <10% in 2022 and 2023. |
Recent developments and announcements about REGN.
Financial Reporting
- EYLEA HD and EYLEA: Combined U.S. net product sales reached $6 billion in 2024, reflecting a 1% year-over-year growth. Q4 2024 sales were $1.5 billion, with EYLEA HD contributing $305 million and EYLEA contributing $1.19 billion.
- Libtayo: Achieved over $1 billion in annual sales for 2024, marking a significant milestone for Regeneron’s oncology portfolio.
- Dupixent: Global net sales for Q3 2024 were $3.8 billion, annualizing at over $15 billion, with continued growth across multiple indications.
- Acquired In-Process R&D Charge: A $14 million pre-tax charge was recorded for Q4 2024, impacting GAAP and non-GAAP net income per diluted share by approximately $0.11.
- Pre-Filled Syringe (PFS): FDA approval and U.S. launch expected by mid-2025.
- Extended Dosing Intervals: FDA review underway for dosing intervals up to 24 weeks for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), with a PDUFA date of April 20, 2025.
- New Indications: Supplemental Biologics License Application (sBLA) submissions for retinal vein occlusion (RVO) and every-4-week dosing planned for Q1 2025.
- COPD Launch: Approved in late 2024 for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. Coverage has been secured from top commercial and Medicare payers.
- Upcoming FDA Decisions: FDA decisions for chronic spontaneous urticaria (CSU) and bullous pemphigoid (BP) are expected by April 18, 2025, and later in 2025, respectively.
- Adjuvant Therapy for CSCC: Demonstrated a 68% reduction in the risk of disease recurrence or death in high-risk cutaneous squamous cell carcinoma (CSCC) in a Phase 3 study. FDA submission is planned for H1 2025.
- Itepekimab (IL-33): Phase 3 results for COPD expected in H2 2025, with potential to address broader respiratory indications.
- Fianlimab (LAG3): Phase 3 data for metastatic melanoma anticipated in H2 2025.
- Pozelimab + Cemdisiran: Phase 3 results for generalized myasthenia gravis expected in H2 2025.
- Linvoseltamab (BCMAxCD3): Biologics License Application (BLA) resubmitted, with launch anticipated in mid-2025.
- Regeneron continues to lead in the anti-VEGF category with EYLEA and EYLEA HD, despite increasing competition.
- The company is expanding its oncology portfolio, with Libtayo positioned as a foundational product.
- Dupixent remains a key growth driver, with new indications and global expansion contributing to its success.
Earnings Report
Regeneron Pharmaceuticals (REGN) Earnings and Business Updates
On January 13, 2025, Regeneron Pharmaceuticals released preliminary (unaudited) financial results for Q4 and FY 2024, alongside updates on its clinical pipeline and product performance. Below are the key highlights:
Financial Performance
Product and Pipeline Updates
EYLEA HD
Dupixent
Libtayo
Pipeline Highlights
Significant Trends
Looking Ahead
Regeneron is poised for further growth in 2025, with multiple FDA decisions, product launches, and pivotal trial results expected across its portfolio. The company’s robust pipeline and strategic focus on innovation position it well to address unmet medical needs in large commercial markets.
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