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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.
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Leonard S. Schleifer ExecutiveBoard | President and CEO | None | Founder of Regeneron in 1988, instrumental in developing 11 FDA-approved drugs and foundational technologies. | View Report → |
Christopher Fenimore Executive | Senior Vice President, Finance and CFO | None | Joined Regeneron in 2003, became CFO in January 2024, previously held various finance roles. | |
Daniel P. Van Plew Executive | Executive Vice President and General Manager, Industrial Operations and Product Supply | None | Joined Regeneron in 2007, oversees industrial operations and product supply, previously at Crucell and Chiron. | |
Jason Pitofsky Executive | Vice President, Controller | None | Joined Regeneron in 2011, transitioned to VP, Controller in February 2024, CPA in New York. | |
Marion McCourt Executive | Executive Vice President, Commercial | None | Joined Regeneron in 2018, promoted to EVP in 2021, previously held senior roles at Axovant, Medivation, Amgen, and AstraZeneca. | |
Arthur F. Ryan Board | Independent Director, Chair of the Corporate Governance and Compliance Committee | None | Director since 2003, former CEO of Prudential Financial, significant experience in financial strategy. | |
Christine A. Poon Board | Director, Lead Independent Director | Director at Prudential Financial, The Sherwin-Williams Company, Neurocrine Biosciences | Director since 2010, extensive experience in pharmaceutical industry, former executive at Johnson & Johnson and Bristol-Myers Squibb. | |
George L. Sing Board | Director | CEO of GanD, Inc., Chair of Grace Science, LLC | Director since 1988, healthcare venture capital investor, significant governance and financial oversight expertise. | |
Michael S. Brown Board | Director | Academic roles at University of Texas Southwestern Medical Center | Nobel Prize laureate, director since 1991, significant contributions to cholesterol metabolism research. |
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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.
| Company | Description |
|---|---|
Genentech/Roche | Competes with EYLEA and EYLEA HD in one or more of its approved indications with other VEGF inhibitors such as Vabysmo and Susvimo. Ophthalmologists are also using off-label, third-party repackaged versions of their approved VEGF antagonist, bevacizumab, for the treatment of certain of EYLEA's and EYLEA HD's respective indications. |
Competes with EYLEA and EYLEA HD with products like Lucentis and Beovu. They are also involved in patent litigation proceedings related to EYLEA. | |
Commercializes biosimilar versions of Lucentis in the United States, competing with EYLEA and EYLEA HD. | |
Sandoz Group AG | Commercializes biosimilar versions of Lucentis in the United States, competing with EYLEA and EYLEA HD. |
Launched a biosimilar version of EYLEA called Pavblu in the United States. They are also involved in an antitrust lawsuit with the company regarding Praluent. | |
Competes with EYLEA and EYLEA HD with their product Ozurdex for DME and RVO. | |
Alimera Sciences, Inc. | Competes with EYLEA and EYLEA HD with their product Iluvien for DME. |
Competes with Dupixent with their product Ebglyss for moderate-to-severe atopic dermatitis. | |
Competes with Dupixent with their product Rinvoq for moderate-to-severe atopic dermatitis. | |
Galderma | Competes with Dupixent with their product Nemluvio/Mitchga for moderate-to-severe atopic dermatitis and pruritus associated with atopic dermatitis. |
LEO Pharma Inc. | Competes with Dupixent with their product Adbry/Adtralza for moderate-to-severe atopic dermatitis. |
Competes with Dupixent with their product Cibinqo for moderate-to-severe atopic dermatitis. | |
Competes with Dupixent with their product Tezspire for asthma. | |
Competes with Libtayo with their product Keytruda for various cancers. | |
Competes with Libtayo with their product Opdivo for various cancers. | |
Competes with Libtayo with their product Unloxcyt for CSCC. |
| 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. |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
2seventy bio, Inc. | 2024 | In April 2024, Regeneron acquired full development and commercialization rights to 2seventy bio, Inc.'s oncology and autoimmune cell therapy pipeline for an up-front payment of $5 million, assuming ongoing costs and milestone-based royalties, complemented by sublease agreements. |
Decibel Therapeutics, Inc. | 2023 | Regeneron completed the acquisition of Decibel Therapeutics at a total equity value of approximately $109 million (potentially up to $213 million with CVR milestones), strengthening its gene therapy and auditory programs with three ongoing gene therapy initiatives, including lead candidate DB-OTO. |
Checkmate Pharmaceuticals, Inc. | 2022 | Completed in May 2022 for a total equity value of about $250 million, the acquisition focused on obtaining vidutolimod for oncology, recorded as an asset acquisition with a $195 million IPR&D charge to enhance Regeneron’s combination-ready oncology portfolio. |
Recent press releases and 8-K filings for REGN.
- Phase III COPD catalyst: The call highlighted progress on itepekimab for COPD, with an interim efficacy analysis that met its hurdle, bolstering confidence in the study's trajectory.
- Oncology advancements: The discussion emphasized a strong oncology pipeline, including the combination of PD-1 (Libtayo) and LAG-3 (fianlimab) for metastatic melanoma and promising bispecifics in myeloma with superior response rates.
- Innovative anticoagulation strategy: Regeneron is advancing two Factor XI antibodies aimed at reducing bleeding risks, potentially expanding anticoagulation therapy usage by improving safety profiles.
- Genetics-driven R&D: The robust Regeneron Genetics Center was underscored as a key asset, leveraging an extensive sequencing database to guide drug discovery and supporting strategic moves like the pending acquisition of 23andMe.
- Regeneron executives discussed the dynamic U.S. pricing environment including MFN policy changes, tariffs, and how these factors might influence their business operations, emphasizing a focus on innovation and careful policy evaluation.
- EYLEA and EYLEA HD were highlighted, detailing competitive pressures from biosimilars and inventory adjustments in Q1, with upcoming catalysts such as a prefilled syringe and enhanced dosing flexibility to reinforce market position.
- Dupixent’s expansion into COPD was mentioned along with promising Phase II results for the pipeline candidate itepekimab, which showed significant reductions in exacerbation rates in specific patient populations.
- Total Q1 2025 revenue reached $3.03B with GAAP diluted EPS of $7.27 and non-GAAP diluted EPS of $8.22, including a 12% YoY GAAP net income increase .
- Dupixent global net sales totaled approximately $3.7B, up 19–20% YoY and serving ~1.2M patients across seven indications, reinforcing its market leadership .
- U.S. EYLEA HD net sales surged 54% to $307M, while total EYLEA sales declined due to competitive pressures and lower inventory levels .
- Pipeline advancements include pivotal clinical readouts and regulatory submissions for Dupixent and EYLEA HD enhancements (prefilled syringe), as well as milestones for LIBTAYO and itepekimab in COPD, with approvals for Dupixent in CSU and Japan’s COPD indication .
- New capital actions announced include a $3.0B share repurchase program and a $0.88 dividend per share, alongside significant investments of over $7B in U.S. manufacturing and R&D expansion .
- Sanofi development balance reimbursement progress featured a ~$180M Q1 reduction, with full completion expected by the end of 2026 to boost collaboration revenue and cash flow .
- EYLEA Franchise Focus: Management detailed plans to enhance the EYLEA portfolio through a prefilled syringe launch, dosing flexibility improvements, and expansion of its label to include RVO, while addressing competitive pressures with modest price increases (2.5% for EYLEA and 2% for EYLEA HD).
- Capital Return Strategy: The company reaffirmed its commitment to shareholder returns, highlighting an increased buyback capacity now at $4.5 billion and the initiation of a $400 million annual dividend.
- Robust Pipeline Update: Several pipeline candidates were discussed, including pivotal Phase II/III data on oncology programs (e.g., cemiplimab, Libtayo, CD3 bispecifics) and new anticoagulation approaches in Factor XI using dual antibodies.