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.