First quarter 2024 revenues increased 7% year-over-year, driven by Sanofi collaboration revenues and Libtayo sales growth. Dupixent global net sales reached $3.1 billion, up 24%.
EYLEA HD generated $200 million in its second full quarter on the U.S. market.
Operating expenses for Q1: R&D grew 17% to $1.1 billion, and SG&A increased 13% to $544 million.
First quarter diluted net income per share was $9.55.
Free cash flow for Q1 was $1.4 billion, with cash and marketable securities less debt at approximately $14.8 billion.
Product and Pipeline Updates
EYLEA HD is positioned as the new standard of care for retinal diseases, with improving payer coverage and direct-to-consumer promotion.
Dupixent for COPD with type 2 inflammation is under FDA priority review with a PDUFA date of June 27. Additional efficacy analyses requested by the FDA.
Itepekimab, an IL-33 antibody for COPD, remains on track for results and potential global regulatory filings in the second half of next year.
Linvoseltamab, a BCMAxCD3 bispecific antibody, is under review for multiple myeloma and is being evaluated for severe allergy in combination with Dupixent.
Fianlimab and libtayo combination shows promise in metastatic melanoma.
Odronextamab and linvoseltamab continue to demonstrate potential in hematology oncology.
Commercial Performance
EYLEA HD U.S. net sales grew 63% sequentially to $200 million.
Dupixent global net sales grew 25% to $3.1 billion, with the U.S. contributing $2.2 billion.
Libtayo global net sales were $264 million, up 44% from the previous year.
Strategic Initiatives and Outlook
Regeneron announced a new $3 billion share repurchase program, demonstrating confidence in its ability to return capital to shareholders.
Minor changes to full-year 2024 financial guidance, with R&D expense now expected to be in the range of $4.4 billion to $4.6 billion.
Question and Answer
Differentiation of Muscle-Sparing Obesity Program
Question
How does Regeneron’s muscle-sparing obesity program, specifically the antibodies targeting BMP and GDF family members, differentiate from competitor programs like bimagrumab?
Answer
Regeneron’s program targets two specific members of the BMP and GDF family that are involved in muscle preservation, potentially avoiding harm from blocking a broader range of factors.
This targeted approach is believed to offer a better safety profile and potentially lead to improved quality of weight loss by preserving muscle and promoting fat loss.
FDA Acceptance of Endpoints for Muscle-Sparing Obesity
Question
What endpoints related to muscle-sparing approaches in obesity does Regeneron believe the FDA would accept, considering the current focus on weight loss as the primary endpoint?
Answer
While weight loss remains a straightforward regulatory endpoint, Regeneron believes the FDA may also consider endpoints such as metabolic parameters, muscle function, and the quality of weight loss (fat versus muscle preservation) as the field evolves.
Demonstrating the quality of weight loss, particularly muscle preservation and increased fat loss, is seen as crucial for potential long-term benefits and differentiation from other weight loss approaches.
Impact of Retina Practice Consolidation on EYLEA Franchise
Question
How does the consolidation of retina practices, such as through private equity acquisitions and GPO purchases, impact the practice of ophthalmology in the U.S. and Regeneron’s go-to-market strategy for the EYLEA franchise?
Answer
Regeneron acknowledges the evolving landscape of retina practice consolidation and its potential impact on the ophthalmology market.
The company’s commercialization approach for EYLEA has been effective in addressing market changes, and it will continue to adapt its strategies to ensure alignment with customer needs and market dynamics.
Potential Labeling and Subpopulation Analysis for COPD Program
Question
Are there any potential restrictions to specific subpopulations in the approval or labeling of Regeneron’s COPD program, despite the consistent data across subgroups in the BLA submission?
Answer
Regeneron believes the data broadly supports the entire BLA for the COPD program, including all subpopulation analyses, and anticipates approval for eosinophilic COPD.
While the FDA rigorously evaluates potential subpopulation effects in new biologic classes, Regeneron’s analyses show consistent and clinically meaningful reductions in COPD exacerbations across all subgroups, suggesting no need for specific restrictions or labeling changes.
Early Clinical Proof of Concept for Severe Food Allergy Study
Question
What specific indicators will be reported in the initial severe food allergy study results by year-end, and what would constitute early clinical proof of concept for linvoseltamab in this indication? How long might patients need to stay on Dupixent to maintain low or no IgE levels?
Answer
The study will initially focus on biomarkers such as IgE levels and skin prick tests to evaluate the potential reversal of severe food allergy.
If early results show dramatic responses in these allergy-causing markers, the study may progress to allergen challenge tests in patients.
The duration of treatment with Dupixent to maintain low or no IgE levels in food allergy patients is still under investigation, with possibilities ranging from relatively short-term to longer-term use, considering the drug’s safety profile and potential benefits for atopic patients.
LAG-3 Program and Implications of Bristol’s Lung Cancer Data
Question
In light of Bristol Myers Squibb’s data suggesting a signal in a subset of lung cancer patients benefiting from PD-1 and LAG-3 combination therapy, what are Regeneron’s latest thoughts on its LAG-3 program and the upcoming Phase II data?
Answer
Regeneron is encouraged by the high levels of activity observed in its LAG-3 program, particularly in melanoma, compared to other LAG-3 programs.
The company is eager to see follow-up details on the BMS data, which may provide insights into specific subpopulations that benefit from LAG-3/PD-1 combinations, potentially guiding Regeneron’s own studies.
The hope is that if LAG-3 is indeed more active in certain settings like melanoma, it will demonstrate broader efficacy across various cancer types and settings, including melanoma and lung cancer.
Safety and Dosing Considerations for Food Allergy Program
Question
Could you comment on the dose of linvoseltamab being tested in the initial severe food allergy study compared to the myeloma setting and what gives confidence in the safety profile? If a patient misses a Dupixent dose, would they need to restart linvoseltamab treatment?
Answer
Regeneron is starting with lower doses of linvoseltamab in the food allergy study compared to the myeloma setting, with an intrapatient dose escalation process to ensure safety.
The company’s confidence in the safety profile stems from data showing that normal plasma cells are more susceptible to bispecific targeting than malignant myeloma cells, as well as the lower incidence of Grade 3 events observed in the myeloma program.
Regeneron anticipates that a short course of treatment with linvoseltamab may be sufficient to achieve the desired effect in food allergy patients, and missing a Dupixent dose likely would not require restarting linvoseltamab treatment due to the gradual reduction of IgE levels.
Bispecifics in Autoimmune Diseases and T Cell Engagers
Question
Given the rise of CAR-T and ADC approaches in lupus and other autoimmune disorders, is Regeneron leveraging its bispecific expertise to explore T cell engagers in these areas?
Answer
Regeneron is actively exploring the potential of bispecifics in autoimmune diseases, including lupus, through its collaboration with 2seventy, which had CAR-T programs targeting these conditions.
The company is now directly comparing CAR-T and bispecific approaches in autoimmune settings to assess the advantages of bispecifics, such as off-the-shelf availability and the ability to spare normal cells while effectively targeting autoantibodies.
Regeneron has initiated studies on bispecifics targeting autoantibodies in autoimmune diseases and is evaluating them in direct comparison with CAR-T approaches through its internal Regeneron cell medicines group.
Education and Uptake for Dupixent in COPD
Question
How much education does Regeneron anticipate will be required for the introduction of Dupixent in COPD, a new space for biologics, and how might the availability of other biologics impact the long-term market and Dupixent’s positioning?
Answer
Regeneron recognizes the need for education and awareness initiatives to support the potential launch of Dupixent in COPD, considering the unmet need in eosinophilic COPD and the novelty of biologic treatments in this area.
The company’s experienced team is already working on launch preparations, applying best practices from previous Dupixent launches and ensuring alignment with reimbursement, affordability, and physician education strategies.
Regeneron will be thoughtful in its approach to reaching physicians and addressing market dynamics to maximize the potential of Dupixent in the COPD market.
Disease Modification and Markets for Itepekimab
Question
Is there potential for disease modification with itepekimab, and what markets beyond exacerbation are being considered for Phase III trials?
Answer
Disease modification is always a possibility with immunomodulatory therapies like itepekimab, and Regeneron believes that both Dupixent in asthma and itepekimab in COPD may have this potential, as suggested by early data on lung function preservation.
The company will assess itepekimab’s impact on long-term disease progression and lung function loss in COPD patients, similar to the approach taken with Dupixent in asthma.
Lenvima Launch and MRD Negativity in Myeloma
Question
How is Regeneron preparing for the potential launch of linvoseltamab in myeloma, and how might the endorsement of MRD negativity as a surrogate endpoint impact the drug’s positioning and future studies in earlier lines of therapy?
Answer
Regeneron is actively preparing for the potential launch of linvoseltamab in myeloma, leveraging the recent data that reinforces its potential as a best-in-class treatment for late-stage myeloma patients.
The endorsement of MRD negativity provides an opportunity to explore linvoseltamab in earlier lines of therapy and different settings, and the company looks forward to applying this approach in future studies.
