Regeneron Pharmaceuticals, Inc. (REGN) 2024 Q2 Earnings Call Summary

Optimistic Highlights

• EYLEA HD Launch Success: EYLEA HD generated $304 million in its third full quarter on the US market, showcasing strong launch trajectory and maintaining a combined EYLEA HD and EYLEA market share of 45%.

• DUPIXENT Global Growth: DUPIXENT global revenues grew 29% on a constant currency basis to $3.56 billion, reflecting strong growth across all approved indications, age groups, and geographies.

• LIBTAYO Performance: LIBTAYO global net product sales were $297 million in the second quarter, an increase of 43% on a constant currency basis, maintaining leadership in non-melanoma skin cancers and making inroads in non-small cell lung cancer.

• Pipeline Progress: Over 35 programs in clinical development across several therapeutic areas, with significant upcoming readouts expected to support long-term growth opportunities.

• Financial Strength: Second quarter 2024 total revenues grew 12% to $3.55 billion, with double-digit revenue and earnings growth.

Pessimistic Highlights

• Linvoseltamab Approval Delay: Potential FDA approval for linvoseltamab is likely to be delayed beyond the August 22 PDUFA date due to third-party fill/finish manufacturer issues.

Company Outlook

• EYLEA HD Pre-filled Syringe Launch: Tracking towards a potential pre-filled syringe launch by early 2025, aiming to position EYLEA HD as the new standard-of-care for retinal diseases.

• DUPIXENT Expansion: Continued growth expected with the recent European Commission approval for COPD and anticipation of FDA decision by the September 27 PDUFA date.

• LIBTAYO and Linvoseltamab Opportunities: Prepared for potential US launch of DUPIXENT in COPD and awaiting FDA and EU decisions for linvoseltamab in late-stage myeloma.

Q & A Highlights

• Q: Regarding the EYLEA franchise, is EYLEA HD reaching a stage of maturity in its launch to maintain overall category share and participate in market growth? (Tyler Van Buren, TD Cowen)

  A: EYLEA HD continues its launch momentum, with net product sales representing 52% sequential growth. The market is tracking more on single-digit growth in the category. (Marion McCourt)

• Q: Can you discuss the rationale for moving the leptin program to Phase II and its potential versus other combination approaches in obesity? (Evan Seigerman, BMO Capital Markets)

  A: The rationale is based on the hypothesis that leptin levels drop with profound weight loss, potentially limiting further weight loss. The study with Lilly's tirzepatide aims to explore if adding leptin can drive further weight loss. (George Yancopoulos)

• Q: As you prepare for the potential launch of linvoseltamab, what feedback are you getting from doctors on its positioning relative to existing therapies? (Brian Abrahams, RBC Capital Markets)

  A: The differentiated clinical efficacy and safety profile of linvoseltamab is recognized, with a highly experienced hematology team in place for the launch. (Leonard Schleifer and George Yancopoulos)

• Q: Can you speak to the differences between your two Factor XI antibodies and the key aspects you'll be focused on in upcoming readouts? (Cory Kasimov, Evercore ISI)

  A: The two antibodies target different domains of Factor XI, potentially offering distinct efficacy and safety profiles. Upcoming readouts will inform future development plans and commercial opportunities. (George Yancopoulos)

• Q: On EYLEA HD, can you discuss the dynamic with Medicare Advantage plans and access barriers even with the J-code change? (Chris Raymond, Piper Sandler)

  A: EYLEA HD has strong payer coverage, covering over 80% of patient lives, with ongoing efforts to work through utilization management or step edits. (Marion McCourt)