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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.
What went well
- EYLEA HD is experiencing strong launch momentum, with net sales increasing by 52% sequentially in its third full quarter, and continues to gain market share, including among treatment-naive patients whose usage doubled from the prior quarter.
- The EYLEA franchise has maintained its leading 45% category share despite increased competition, demonstrating Regeneron's strong market position in retinal diseases.
- Regeneron's Factor XI programs have the potential to tap into the $20 billion anticoagulant market by offering similar or better efficacy with improved safety profiles, representing a significant future growth opportunity.
What went wrong
- Regeneron may be missing growth opportunities by not pursuing large-scale acquisitions despite having a strong balance sheet, particularly in the eye disease area where substantial external innovation is happening.
- Potential delays in the approval and launch of linvoseltamab due to third-party manufacturing issues, including FDA reinspection requirements, could impact near-term revenue growth.
- The retinal disease market is growing at mid-single digits rather than the expected 10%, which could limit the growth potential of EYLEA HD and the overall EYLEA franchise.
Q&A Summary
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EYLEA HD Market Share and Growth
Q: Is EYLEA HD mature enough to stabilize market share and growth?
A: Management reports $1.54 billion in total net sales this quarter, a 2.4% increase year-over-year. EYLEA HD net sales increased by 52%, adding $100 million from the prior quarter. They are encouraged by switches from competitors and note that use in treatment-naive patients doubled from the prior quarter , suggesting EYLEA HD could become the new standard of care. Overall market growth is tracking mid single-digits, not 10%. -
EYLEA HD Access Barriers and J-code
Q: How are access barriers impacting EYLEA HD post permanent J-code?
A: Management states that for fee-for-service Medicare patients, there's open access. In areas with payer impact, they've secured coverage for over 80% of patient lives. While some utilization management exists, they are addressing these issues. Overall, EYLEA HD has strong payer coverage. -
linvoseltamab Launch and Manufacturing Issues
Q: Can you elaborate on linvo's launch prep and third-party facility issues?
A: FDA observations at a third-party filler for a different product require reinspection, likely delaying linvoseltamab's approval past the PDUFA date. Management believes the issues have been remediated and is working with the FDA for a quick resolution. They emphasize linvo's differentiated efficacy and safety profile and plan to move into earlier lines of therapy. -
Factor XI Program Development and Opportunity
Q: Can you discuss your Factor XI antibodies and their potential?
A: Regeneron has two best-in-class antibodies targeting different parts of Factor XI to optimize efficacy and safety profiles. They expect proof-of-concept data by year's end to decide directions. With the $20 billion anticoagulant market in mind, they aim to deliver similar or better efficacy with improved safety. -
DOJ Investigation into EYLEA Marketing Practices
Q: Has the DOJ investigation affected practices or prescribers?
A: Management asserts there's nothing to the lawsuit, they've not changed their practices, and intend to fight it vigorously. They see no market impact related to this issue. -
Obesity Program with Leptin Combination
Q: What's the rationale for leptin Phase II with tirzepatide?
A: Regeneron believes that after weight loss, falling leptin levels may drive increased feeding behavior. By adding leptin to tirzepatide, they aim to overcome weight loss plateaus and achieve further weight loss. Studies are in collaboration with Lilly. -
Potential Acquisitions in Eye Disease
Q: Are there opportunities to acquire novel therapies for eye disease?
A: Management considers opportunities daily but currently sees no large-scale acquisitions that fit their strategy. They remain open to leveraging their capabilities but find no significant late-stage products to acquire at this time. -
DUPIXENT in Food Allergy Market
Q: How many patients could benefit if data supports DUPIXENT for food allergy?
A: The potential market is large, starting with the most severe food-allergic patients. If proven safe and effective, the treatment could expand to milder allergies, benefiting patients already using DUPIXENT for other allergic diseases. Management notes the numbers could be staggering, with hundreds of thousands of emergency visits for food-based allergies annually. -
EYLEA HD Conversion and Uptake
Q: How should we think about EYLEA HD conversion pace and uptake?
A: Management is pleased with progress, noting that utilization among treatment-naive patients doubled from the prior quarter. They are seeing ongoing switches from EYLEA, faricimab, and Avastin, with increased use in naive patients. They continue to see EYLEA HD prescribing evolve positively. -
VABYSMO Pre-filled Syringe Competition
Q: Will EYLEA HD launch momentum be disrupted by VABYSMO's pre-filled syringe?
A: Management anticipates launching their own pre-filled syringe in early 2025, only months apart from competition. They believe this won't significantly impact the market, as physicians focus on EYLEA HD's profile, durability, and established safety. -
Myostatin Program and Combination Approach
Q: What's your preference for doublet vs. triplet in myostatin trials?
A: Regeneron aims to optimize pathways by precisely dissecting mechanisms. They focus on combining weight loss agents with myostatin pathway blockers to maximize fat loss while preserving muscle. Their approach may provide a safer and more effective solution than other methods.
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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?
Q2 2024 Earnings Call
- Issued Period: Q2 2024
- Guided Period: FY 2024
- Guidance:
- Gross Margin: Expected to be approximately 89%, reflecting anticipated changes in product mix and higher non-product specific costs, including start-up costs for their fill/finish facility .
- Sanofi Development Balance: Anticipated to be fully reimbursed to Sanofi by the end of 2026 .
Q1 2024 Earnings Call
- Issued Period: Q1 2024
- Guided Period: FY 2024
- Guidance:
- R&D Expense: Expected to be in the range of $4.4 billion to $4.6 billion, due to the inclusion of operating expenses associated with the acquisition of 2seventy bio development programs .
- U.S. Net Sales of Praluent: Expected to be modestly higher in 2024 compared to 2023, primarily due to a gross to net adjustment related to a true-up of rebates due to an adverse change in payer coverage .
Q4 2023 Earnings Call
- Issued Period: Q4 2023
- Guided Period: FY 2024
- Guidance:
- R&D Expense: Expected to be in the range of $4.3 billion to $4.5 billion .
- SG&A Expense: Expected to be in the range of $2.5 billion to $2.65 billion .
- COCM (Cost of Collaboration Manufacturing): Expected to be in the range of $850 million to $910 million .
- Gross Margin on Net Product Sales: Expected to be in the range of 89% to 91% .
- Effective Tax Rate: Expected to be in the range of 10% to 12% .
- Capital Expenditures: Expected to be in the range of $825 million to $950 million .
- U.S. Net Product Sales of Praluent: Expected to be lower in 2024 compared to 2023 due to changes in payer coverage .
- Net Product Sales for Inmazeb: Expected to be in line with 2023 revenues, with nearly all 2024 revenues expected to be recorded in the fourth quarter .
- Other Revenue: Expected to be in line with 2023, with the second half expected to be higher than the first half .
Q3 2024 Earnings Call
- Issued Period: Q3 2024
- Guided Period: N/A
- Guidance: The documents do not provide information on the guidance given during Regeneron's Q3 2024 earnings call. The available data only covers up to Q2 2024.
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) .
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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