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    REGENERON PHARMACEUTICALS (REGN)

    Q1 2024 Earnings Summary

    Reported on Jan 10, 2025 (Before Market Open)
    Pre-Earnings Price$903.48Last close (May 1, 2024)
    Post-Earnings Price$900.00Open (May 2, 2024)
    Price Change
    $-3.48(-0.39%)
    • Linvoseltamab, Regeneron's potential best-in-class product for late-stage myeloma patients, has an upcoming PDUFA date on August 22. The company is preparing for its potential launch, which could extend their oncology franchise into a new disease area.
    • Regeneron is preparing for the potential launch of Dupixent in COPD, addressing significant unmet needs in eosinophilic COPD patients. Their experienced team is confident in helping these patients and building on their success in asthma.
    • Regeneron is confident that Dupixent shows a consistent and clinically meaningful reduction in COPD exacerbations across all subgroups, supporting broad approval for eosinophilic COPD.
    • Challenges in launching Dupixent for COPD due to required physician education and competition. The need to educate physicians in a new space for biologics might affect initial uptake of Dupixent, and other biologics showing promise could impact its long-term market positioning.
    • Regulatory uncertainty regarding acceptable endpoints for muscle-sparing obesity treatments. FDA's acceptance of endpoints beyond weight loss is uncertain, potentially complicating development and approval of Regeneron's muscle-sparing obesity program.
    • Difficulty differentiating muscle-sparing obesity program amid competition. Competitors have muscle-sparing programs, and Regeneron may face challenges in differentiating its approach from others.
    1. Dupixent in COPD Approval
      Q: Could there be subpopulation restrictions for Dupixent in COPD?
      A: Management believes the data supports approval of Dupixent for eosinophilic COPD without restrictions. They have conducted extensive analyses showing consistent and clinically meaningful reductions in COPD exacerbations across all subgroups and plan to submit these ahead of schedule.

    2. Linvoseltamab Launch Strategy
      Q: How are you preparing for the linvoseltamab launch and earlier myeloma lines?
      A: They are preparing for the potential launch of linvoseltamab with an August 22 PDUFA date, excited by recent data reinforcing it as potentially a best-in-class product for late-stage myeloma patients. Management is considering minimal residual disease (MRD) negativity as a surrogate endpoint to move into earlier lines of therapy faster.

    3. Obesity Program Differentiation
      Q: How does your muscle-sparing obesity program differ from competitors?
      A: Their program targets only two specific members of a large family involved in muscle preservation, potentially offering better safety by avoiding blocking over a dozen factors like competitors do. This selective approach aims to preserve muscle while increasing fat loss, improving weight loss quality.

    4. Dupixent COPD Launch Preparation
      Q: Will physician education affect Dupixent's COPD launch and competition?
      A: The team is experienced with Dupixent launches and is applying best practices for the COPD indication. Many physicians are already familiar with Dupixent's benefits. They aim to ensure reimbursement and affordability, anticipating strong uptake despite potential competition from other biologics.

    5. EYLEA Inventory and Market Changes
      Q: Did market consolidation affect EYLEA inventory or strategy?
      A: There was a $40 million reduction in wholesaler inventory due to a sequential drawdown of EYLEA, partly offset by an increase in EYLEA HD inventory ahead of a new J-Code. Management remains effective in addressing market evolution, including consolidation of retina practices by entities like McKesson.

    6. Food Allergy Study Expectations
      Q: What do you expect from the initial severe food allergy study results?
      A: They hope to see meaningful indicators of reversing severe food allergy by reducing IgE levels. Depending on results, they may proceed with allergen-challenge tests. Treatment duration with Dupixent could be short-term or longer, but it is considered safe and potentially beneficial for patients with atopic diseases.

    7. Bispecifics in Autoimmune Diseases
      Q: Are you leveraging bispecific expertise in autoimmune conditions like lupus?
      A: Yes, they are exploring bispecific antibodies in autoimmune diseases, comparing them directly to CAR-T approaches. Through their acquisition of 2seventy, they're conducting studies to assess efficacy and safety, believing bispecifics could be more convenient and safer than CAR-T therapies.

    8. LAG-3 Program and Lung Cancer
      Q: How do Bristol's findings on PD-1 and LAG-3 affect your program?
      A: They are excited about their own program's unprecedented activity in melanoma and hope it translates to other cancers, including lung cancer. They look forward to seeing more data from Bristol and comparing it within their studies, particularly in specific subpopulations.

    9. Itepekimab's Disease Modification Potential
      Q: Could itepekimab offer disease modification in COPD beyond exacerbations?
      A: Management believes there's potential for disease modification, similar to Dupixent in asthma. They are examining long-term preservation of lung function and prevention of lung capacity loss in COPD patients, which could indicate modifying the disease course.

    10. Linvoseltamab in Food Allergy
      Q: How does linvoseltamab dosing in food allergy compare to myeloma?
      A: They are starting at much lower doses than in myeloma, with an intrapatient dose escalation. They believe normal plasma cells are more susceptible, expecting better safety with lower doses. Missing a Dupixent dose likely doesn't require restarting treatment, as IgE levels take time to rebound.

    Research analysts covering REGENERON PHARMACEUTICALS.