Side B siRNA program for MASH
Q: Elizabeth Webster from Goldman Sachs asked how Regeneron frames the Side B clinical data in the context of the competitive landscape, where the asset will be positioned, and the key aspects of differentiation.
A: George Yancopoulos, President and Chief Scientific Officer, explained that competing approaches to MASH are indirect and do not target the fundamental genetic pathway, whereas Side B is a genetically validated target. He highlighted unprecedented liver fat reductions on the order of 70% achieved in just a few weeks from a single dose.
Cemdisiran prelaunch activities
Q: Brian Abrahams from RBC Capital Markets asked about prelaunch activities and learnings for cemdisiran in generalized myasthenia gravis, alongside the initial target audience and uptake expectations.
A: Marion McCourt, Executive Vice President of Commercial, stated that the neurology team is talented and experienced, launch preparation and activities are well underway, and the company is launch ready for the November PDUFA date.
Sanofi collaboration and oral agents
Q: Akash Tewari from Jefferies asked if an oral STAT6 agent delivering efficacy similar to Dupixent would be an asset Regeneron would be interested in adding to the ongoing collaboration with Sanofi.
A: Leonard Schleifer, Chief Executive Officer, noted that oral agents are a long way from matching the efficacy and safety of Dupixent pathway blockers, and that a daily pill does not offer a significant convenience advantage over an injection given once a quarter or every six months, though the alliance remains open to exploring opportunities.
Business development and pipeline strategy
Q: Tyler Van Buren from TD Cowen asked if Regeneron will become more aggressive in business development and at what stage of development acquiring external assets is ideal.
A: Leonard Schleifer, Chief Executive Officer, responded that the company evaluates overall spend on internal and external innovation and remains open to all opportunities at all stages, focusing primarily on the underlying science and platform potential.
Next-generation antibodies
Q: June Lee from UBS asked whether Regeneron needs all four next-gen antibodies from patent filings to succeed or if there are different plans for different indications.
A: George Yancopoulos, President and Chief Scientific Officer, stated that the development plan anticipates that some assets might be better tailored for specific settings compared to others.
Competitive landscape in type 2 inflammation
Q: Tazeen Ahmad from Bank of America asked for an updated view on the competitive landscape in atopic dermatitis, specifically whether long-acting treatment alone is sufficient to compete or if improved efficacy over Dupixent is needed.
A: Leonard Schleifer, Chief Executive Officer, drew parallels to Eylea, noting that improving upon a proven mechanism is difficult, and added that while others may pursue long-acting options, very few will match the collective experience and capabilities of Sanofi and Regeneron.
MASH antifibrotic mechanism and trials
Q: Eliana Merle from Barclays asked about the antifibrotic mechanism seen in the MASH program, the context versus the FGF21 class, and strategy regarding histologic versus noninvasive endpoints in registrational studies.
A: George Yancopoulos, President and Chief Scientific Officer, stated that the genetic pathway protects against multiple aspects of liver disease and that early clinical data mirror the genetics, with further details to be shared at the November 10 roundtable event.
Commercial versatility and obesity strategy
Q: Gregory Renza from Truth Securities asked at what stage breadth across therapeutic areas presents execution risks, and how the team is willing to invest in the obesity space.
A: Leonard Schleifer, Chief Executive Officer, acknowledged that managing multiple development and commercial efforts is a primary internal focus, but noted that Regeneron's diverse specialist experience prepares them well for execution.
Sanofi alliance strategy for next-gen antibodies
Q: Evan Seigerman from BMO Capital Markets asked what unmet need the expanded Sanofi alliance for next-gen type 2 inflammation antibodies aims to solve that Dupixent cannot, and whether they are franchise expansion or replacement products.
A: Leonard Schleifer, Chief Executive Officer, declined to unveil the strategy on the call, stating there is a better format to discuss these plans with Sanofi over time.
PNH combination therapy and patient switching
Q: Alexandria Hammond from Wolf Research asked about expectations for patient switching in PNH given the combination data and whether the patient population is considered sticky.
A: Marion McCourt, Executive Vice President of Commercial, stated that early clinical results are exciting and compelling, and the company looks forward to bringing the product and indication into the marketplace pending additional clinical data differentiation.

