Q4 2023 Earnings Summary
- EYLEA HD is experiencing positive early adoption with significant physician confidence, driven by real-world data showing efficacy, safety, and durability. Anticipated factors such as the forthcoming permanent J-code on April 1 are expected to accelerate its uptake by enhancing reimbursement confidence among physicians.
- The anti-VEGF market remains healthy with growth opportunities, supported by increasing numbers of individuals diagnosed with diabetes and an aging population, which bodes well for EYLEA and EYLEA HD demand.
- Regeneron's innovative obesity pipeline, including the muscle-sparing myostatin program and targeting of the GPR75 receptor, has shown promising preclinical and early clinical results, with potential to significantly impact the obesity market in the next 1 to 1.5 years.
- Regeneron is experiencing price erosion and contracting revenues for the 2mg EYLEA format due to increasing competition in the anti-VEGF market, which may negatively impact overall revenues.
- The anti-VEGF market may be slowing down, as management noted a decline of a couple of points between last year and this year overall, indicating potential challenges for market growth.
- Adoption of EYLEA HD may be hindered until a permanent J-code for reimbursement is effective on April 1, with physicians hesitant to prescribe without it, potentially affecting near-term sales.
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EYLEA HD Uptake
Q: What factors will accelerate EYLEA HD conversion?
A: The early performance of EYLEA HD is encouraging, driven by clinical data showing efficacy, safety, and durability. Key factors that will accelerate conversion include physicians building on their early experience, the upcoming permanent J-code expected on April 1 , and progress in payer coverage. Reimbursement confidence is very important, as some physicians hesitate to prescribe without a permanent J-code. -
Obesity Program Differentiation
Q: How does your obesity portfolio stand out?
A: Our obesity program is unique because we discovered two key ligands controlling muscle size, Myostatin 1 and Myostatin 2, and have specific blocking antibodies for both. We're testing them individually and together to achieve muscle preservation during GLP-1 agonist treatment, while also ensuring safety. We're also developing unimolecular solutions combining tethered GLP-1 with antibodies for potential once-a-month dosing. -
EYLEA Pricing Outlook
Q: Do you expect further price erosion for 2 mg EYLEA?
A: We view the market as very competitive, and there has been some price erosion on products. With EYLEA HD, we believe we priced it well and it was received positively, matching on a yearly basis. We don't want to comment specifically on future pricing strategies. -
Linvoseltamab Commercialization
Q: How will you convert prescribers to linvoseltamab?
A: It starts with a best-in-class molecule; it's about the science. We've successfully launched into competitive categories before, like with EYLEA displacing Lucentis, and we're confident we can do it again with strong execution. Our oncology team is well-prepared, and we're excited to help patients with linvoseltamab. -
Capital Allocation Plans
Q: How will you use the growing cash balance?
A: Our top priority is to fully fund research and development, with 8 to 10 INDs coming. We're proud of our buybacks and will continue our methodology. Regarding business development, we'll remain prudent; any moves must fit our franchise and modalities, and be incremental to our current pipeline. -
Anti-VEGF Market Trends
Q: How is the anti-VEGF market trending?
A: The anti-VEGF category is overall healthy from a growth standpoint, driven by the number of individuals with diabetes and an aging population. There's variability between quarters and years, and recently there has been a decline of a couple of points between last year and this year. -
Muscle-Sparing Myostatin Program
Q: Concerns about muscle function with myostatin targeting?
A: Our studies show that the muscle is functional and important for metabolic and energy expenditure. There's variety in regulatory pathways; if we see increased weight loss, that might suffice as a strategy, or we might need to show functional outcomes in strength. Results from initial studies over the next year to 1.5 years will inform our path. -
Geographic Atrophy Program
Q: Why confidence in systemic approach for GA?
A: We believe we have the most effective way of blocking C5 activity by targeting it systemically, as C5 comes from the liver. Our Phase III PNH studies showed best-in-class activity in decreasing C5. Blocking at the source avoids local side effects like retinal vasculitis, but we need strategies to mitigate increased infection risks in the elderly. -
2seventy Deal Implications
Q: How does the 2seventy deal affect your strategy?
A: We've been long-standing partners with 2seventy, and now we're excited to combine our large portfolio of biologics in immunotherapy with their cell therapy capabilities. This allows us to pioneer new combination approaches against cancer, bringing a new level to the immunotherapy field. We believe we'll be unique in this capability.