Regeneron (REGN) Q2 FY26 earnings call: guidance and Q&A

Given significant cash on hand and the Sanofi obligation rolling off, how does Regeneron balance robust internal investment with M&A, especially considering past 'aversion' to overpaying?

Len clarified that he is not averse to M&A but is disciplined about valuation. He stated that Regeneron's R&D spend (internal and external) is in line with peers, but they prioritize internal R&D. They are open to small or large external opportunities if they make financial sense for shareholders.

“I don't think I expressed the conversion to M&A. I think I expressed the inversion to overpaying in M&A settings.”

asked by Chris Raymond · answered by Leonard Schleifer

What are the latest thoughts on expanding the Sanofi collaboration for additional I&I assets, and how can development be accelerated?

Len confirmed productive early discussions with Sanofi regarding follow-on Dupixent opportunities, including the long-acting IL-13 antibody. George emphasized their track record of innovative development with Dupixent and their ability to be innovative with next-gen assets. They aim for a relationship reflecting the current standing of both companies.

“We have had productive early discussions. The new CEO, and I have talked multiple times, we are looking to see what might make sense and what kind of transaction might make sense for the 2 companies to get together on further assets.”

asked by Taylor Hanley · answered by Leonard Schleifer

Provide details on the EYLEA HD PFS review, the goal of year-end approval, and clarify if 'multiple contract manufacturers' means a third CMO is involved and which one is most likely for approval.

Len acknowledged FDA changes and renewed discussions. He stated they are 'leaving no stone unturned' and 'multiple and that means more than two' CMOs are in the mix. He expressed optimism for approval by year-end or sooner, emphasizing the product's strong performance even without PFS.

“multiple and that means more than two are in the mix. We could always use backups if we succeed on 1 3, 1 and 2, 2 and 3 or 3 and so forth. But we're doing everything we can.”

asked by Tyler Van Buren · answered by Leonard Schleifer

What percentage of the GMG market is currently served by IV C5 therapies, and what is the expected switch market development for cemdisiran?

Marion stated it's early to predict uptake specifics but highlighted cemdisiran's efficacy, safety, and convenient dosing as key differentiators. Len added that the switch population is a 'lower-hanging fruit,' but cemdisiran can compete across all segments due to its continuous effect and infrequent dosing, contrasting with the cycling seen with FcRN approaches.

“We think that the unpredictable nature of all that compared to giving something every quarter by a simple injection is really going to be changing the practice and the way patients think about it.”

asked by Unknown Analyst · answered by Leonard Schleifer

How will Regeneron's ceRNA programs for MASH differentiate from approved agents like resmetirom, and what is the commercial opportunity, especially with GLP-1 uptake?

George explained that Regeneron's agents directly address the genetic mechanisms of NASH, aiming to reverse the disease more quickly and deeply, unlike other agents that work indirectly (e.g., by decreasing food intake). He emphasized that their approach is based on genetic discoveries.

“All other agents in this in this field are not really directly addressing the mechanism of NASH itself... we discovered actual genetic mechanisms that are protective for the actual basis of this disease.”

asked by Salveen Richter · answered by George Yancopoulos

What incremental data points beyond LDH control and transfusion avoidance are needed for a best-in-class label claim, and what is the regulatory/commercial path and timeline?

George stated that improved control of intravascular hemolysis is the most relevant and validated endpoint, directly reflecting the C5 mechanism and preventing devastating consequences like thrombosis. He believes this would demonstrate differentiation and potential superiority, alongside a more convenient dosing regimen.

“We strongly believe that improved control of intravascular hemolysis is the most relevant and validated endpoint because it's directly reflects to C5 mechanism of action and it's directly related to preventing what are the most devastating consequences of these disease, which is thrombosis and clotting and so forth.”

asked by Alexandria Hammond · answered by George Yancopoulos

What is the realistic timeline for the GLP-1/GIP and Praluent combination, and how will it differentiate to carve out market share?

George stated Phase III initiation for oloreptitide is in the next few months, and the combination is advancing. He emphasized differentiation by addressing comorbidities (e.g., lowering cholesterol by 50-60% with Praluent) and countering side effects like muscle loss, rather than just incremental weight loss.

“everybody is trying to compete by getting a few more percentage points of weight loss... what we're trying to do is provide a fundamentally a substantially different profile.”

asked by Gregory Renza · answered by George Yancopoulos

Following samimab setbacks and slow progress, is Regeneron reassessing its solid tumor portfolio, and will it continue to warrant the same spend and attention?

George acknowledged cancer's challenges and samimab's numerical activity despite missing the primary endpoint. He affirmed continued excitement and investment in their broad oncology pipeline (solid and liquid tumors), taking 'more shots in many different ways' with unique agents, despite the field's difficulty.

“We have a lot of programs, many programs both in solid and liquid tumors -- we continue to be very excited about them and moving them forward. And if anything, we are continue to advance and continue to take more shots in many different ways.”

asked by Carter Gould · answered by George Yancopoulos