Regeneron (REGN) Q1 FY26 earnings call: guidance and Q&A

Discuss willingness to collaborate with Sanofi on next-gen DUPIXENT assets given its success and the upcoming patent cliff, or if Regeneron will pursue these independently.

Len thanked Paul Hudson and welcomed Belen Garijo. He stated Regeneron is open-minded to transactions leveraging its development and commercial capabilities, but can also pursue opportunities independently. He looks forward to discussions with Sanofi's new leadership.

“We are always open-minded to transactions certainly leveraging what we've built in terms of both development capabilities as well as commercial capabilities has merit to it. We can do these things ourselves. We've had interest for many different places to sort of take on some of the next opportunities with us.”

asked by Tyler Van Buren · answered by Leonard Schleifer

Is PFS differentiation enough for majority market share, or is OS data also needed?

George stated that it depends on the PFS results, but the study is designed to show a substantial OS benefit if one exists. The hope is to see both PFS and OS benefits.

“But the study is also designed so that -- if we have a substantial OS benefit, we will see that as well. And so the hope, of course, is that the study will show both the PFS and an OS benefit.”

asked by Chun Yu · answered by George Yancopoulos

Why did FDA miss the PDUFA date? Was the Catalent reinspection positive? What's the timing for approval?

Len stated that the FDA missed the PDUFA date and the application remains pending. He could not confirm if the reinspection was positive but indicated that based on conversations and the FDA's desire to get products out, they anticipate a regulatory decision on one or both applications during the current quarter (Q2 FY26).

“And the only thing I can say is that based on our conversations and how hard everybody is working at this and the FDA, I think, desire to get these sites up to the standards they want as well as get the products out there that are waiting that we anticipate action on one or both of these during this quarter.”

asked by Sam Lee · answered by Leonard Schleifer

How does Regeneron address concerns about infection risk with BCMA bispecifics, especially in earlier-stage patients, compared to existing standards of care?

George explained that the disease itself carries substantial infectious risk. He noted that in their studies, longer treatment and better disease control actually led to a decrease in infectious risk over time. He believes bispecifics, including Lynozyfic, will become the dominant class due to impressive efficacy and overall tolerability, including infectious risk profile.

“if you actually look at our detailed data and publications on the matter, it actually turns out that the longer you treat these patients, the more you control your disease, the more functional their bone marrow becomes actually infectious risk goes down over time, which is actually quite stunned.”

asked by Cory Kasimov · answered by George Yancopoulos

How to accelerate development and remain competitive in the rapidly evolving obesity market?

George highlighted the potential for a GLP that also lowers bad cholesterol by over 50% and reduces cardiovascular outcomes, positioning it as a preferred GLP. He noted positive cross-trial comparisons with tirzepatide from Chinese data. He emphasized the convenience of co-formulated auto-injectors and competitive pricing, arguing it's a "no-brainer" given the high comorbidity of cardiovascular risk and hyperlipidemia in the obese population. Len added that recommendations for lipid-lowering drugs are catching up to science, broadening the target population.

“imagine if you invented a GLP that was as good as the currently best-in-class agent, let's say, tirzepatide, and acted very much the same, but also lowered your bad cholesterol by more than 50% and was shown to decrease your risk of cardiovascular outcomes like heart attacks and death, that GLP would become the preferred GLP on the planet, especially if you priced it at a very similar price.”

asked by Evan Seigerman · answered by George Yancopoulos

Identify specific late-stage pipeline candidates expected to generate multi-billion dollar peak sales with near-term catalysts.

Len listed several programs: C5 franchise (cemdisiran), 11 Phase III anticoagulation trials (Factor XI), bispecifics in myeloma (Lynozyfic) and lymphoma (odronextamab), olatorepatide (GLP/GIP) and its Praluent combo, and fianlimab + Libtayo in metastatic melanoma. George added that past performance (two $10B+ blockbusters) indicates future success, and that the oncology programs, C5 franchise, Factor XI, and obesity opportunity all have multi-billion dollar potential.

“There's only one company in recent history that of its own labs produced two $10 billion plus blockbusters. And let me remind you that I think you and probably a lot of other investors never saw those coming or ignored what we were saying about them.”

asked by David Risinger · answered by Leonard Schleifer

Context for not moving to Phase III in lung, observations in data, and read-through to melanoma or other solid tumors.

George stated that they never indicated excitement for lung cancer, and earlier data always pointed to melanoma. He said the melanoma data will guide future decisions for other cancer settings. Len added there were no negative read-throughs from new side effects or unanticipated issues.

“we never had any reason to really believe that this was going to be a game changer in the lung cancer space.”

asked by Geoff Meacham · answered by George Yancopoulos