Regeneron (REGN) Q4 FY25 earnings call: guidance and Q&A

Seeking more specific timing for metastatic and adjuvant melanoma data for LIBTAYO plus fianlimab beyond the first half of 2026, and if the adjuvant interim update will coincide with the metastatic readout.

Management reiterated that the first half of 2026 is the best estimate for both metastatic and adjuvant melanoma readouts, noting they may or may not coincide, and data will be released shortly after it's available.

“We don't really have any additional clarity right now on the timing for the advanced melanoma readout. First half is the best estimate at this time. In terms of the adjuvant timing, that's also in the first half. They may coincide, they may not.”

asked by Alexandria Hammond · answered by Ryan Crowe

Asked for Regeneron's commentary on Sanofi's recent statements regarding extending DUPIXENT's IP runway to 2040 or beyond.

Len Schleifer deferred to Sanofi's comments. George Yancopoulos highlighted Regeneron's pipeline of long-acting IL-13, IL-4, and IL-4/IL-13 bispecifics, and a 'supi-dupi' molecule, emphasizing DUPIXENT's unique efficacy and safety profile due to its specific targeting of allergic disease pathways without generalized immunosuppression.

“I think we should highlight the fact that we have also a lot of exciting follow-on opportunities in this space, particularly with our collection of what we hope will prove to be the best-in-class long-acting IL-13, IL-4 and IL-4/IL-13 bispecifics as well as what we call a new supi-dupi molecule that is a new version of DUPIXENT that was naturally selected that might have even more improved properties.”

asked by Christopher Raymond · answered by George Yancopoulos

Inquired about the expected hazard ratio bar for the frontline metastatic melanoma data and commentary on PD-L1 expression levels in the patient population.

George Yancopoulos stated the study is powered for a PFS effect analogous to the current standard of care, with hopes for better, and is also powered to demonstrate an overall survival benefit. Ryan Crowe clarified that PD-L1 status is not an inclusion/exclusion criterion, aiming for a true first-line advanced melanoma population.

“This study is largely powered to get an effect in terms of the primary endpoint, which is the PFS analogous to the current combination standard of care. I hope -- of course, we hope that we might actually achieve better. We have 2 dose groups in the study and so forth. But we're also powered that if we were to hit at that level as the current standard of care, we would also hope to demonstrate a benefit in the study is appropriately powered to pick up an overall survival benefit.”

asked by Salveen Richter · answered by George Yancopoulos

Asked about the differentiation of Regeneron's GA program compared to existing approved drugs, and whether a visual acuity benefit is necessary or if slowing vision loss with a better safety profile would suffice.

George Yancopoulos emphasized the potential for more profound C5 blockade with their technologies, exploring both systemic and local approaches to avoid blinding risks associated with current therapies. He also noted the flexibility of testing monotherapy (cemdisiran) and combination (cemdisiran + pozelimab). Len Schleifer added that C5 is systemically produced. Ryan Crowe confirmed a prospective secondary endpoint for 15-letter visual acuity loss.

“So one possibility and opportunity, of course, is that by providing more profound blockade, one might actually see better benefit. Another, of course, important aspect of our program is we are trying both systemic blockade as well as local blockade.”

asked by Tazeen Ahmad · answered by George Yancopoulos

Inquired about the co-formulation technology enabling both PCSK9 and GLP/GIP agonist in a single auto-injector and the potential for partnering this asset to share development costs.

Len Schleifer stated they are open to deals but do not comment on specific discussions. George Yancopoulos attributed the co-formulation success to their formulations group, enabling delivery of both an antibody and a peptide in a single auto-injector. He highlighted the differentiated benefit of combining profound weight loss with 50-60% LDL cholesterol lowering for obese patients with hyperlipidemia.

“But as you touched on it, that's the magic, and that's the secret of our capabilities, best-in-class formulations group that delivered unprecedented formulation capability with EYLEA and EYLEA HD, it's the same people doing the same things that have figured out how to magically be able to get into an auto-injector, a very similar autoinjector that's used just for your GLP in a similar sort of volume, both the antibody and a peptide.”

asked by Akash Tewari · answered by George Yancopoulos

Asked what Regeneron will focus on in Bayer's upcoming Phase III data for their oral Factor XI inhibitor, asundexian, in relation to Regeneron's Factor XI antibody program.

George Yancopoulos stated that while there will be some read-through, it's difficult to compare small molecules to antibodies due to differences in specificity and off-target effects. He believes Regeneron's Factor XI antibody will offer a substantially differentiated profile with better anticoagulation and less bleeding, potentially allowing for convenient, occasional or monthly dosing, unlike oral small molecules.

“I mean it is very hard to compare these small molecules with antibodies. As we know, historically, and it's the case here, small molecules suffer from both lack of specificity, we know they inhibit multiple proteases, including the target of interest here. And they also have off-target effects as well.”

asked by Terence Flynn · answered by George Yancopoulos

Asked about the confidence in moving the GLP-1/GIP into Phase III trials given the evolving market, and its differentiation from current and advanced assets.

Len Schleifer emphasized the key differentiation is the ability to combine the GLP-1/GIP with their PCSK9 inhibitor in a single syringe, targeting obese patients with hyperlipidemia. George Yancopoulos added that olatorepatide has shown tirzepatide-like efficacy and safety in China, and the strategy is to provide a completely new benefit (50-60% LDL lowering) on top of weight loss, rather than just competing on incremental weight loss.

“So I think if you go back and listen carefully to what George was saying that the biggest advance here from our perspective is the ability to combine this with our PCSK9 inhibitor. There are only 2 approved PCSK9 antibodies and the ability to combine this antibody with these peptides in the same syringe at the same dosing interval, I think that's highly differentiated for the 15% -- 50% or more of people who are obese and have high cholesterol.”

asked by Evan Seigerman · answered by Leonard Schleifer