Regeneron Pharmaceuticals Inc Q2 2025 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Timothy Anderson - BofA Global Research - Analyst : Good Q2 results, but I have a policy question that's on MSN and the (inaudible) letters that were sent out. Three of those letters had the CEO names crossed out, replaced with first names that were kind of penciled over. That was Lilly, Pfizer and Regeneron, and it makes me wonder, is there a closer relationship between those CEOs and Trump? I know Lilly and Pfizer have been the (inaudible) a lot to influence policy. So my question is, Len, have you been down there frequently as well? I asked because of common assumption, is that MSN might play out through a CMMI demo product. EYLEA is a big part -- the drug. Could that get wrapped into it or not because there's a biosimilar. So some visibility. Any (inaudible) on any of this would be appreciated. Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder Yes. Thanks. I've been down there frequently. I think President probably knows Regeneron and my first name, given that it was Regeneron's cocktail for COVID that may have saved his life. Beyond that, I don't have any great insights to the policies. I have been and the company has been outspoken that we agree with the President that the Europeans are not paying their fair share of innovation and some way that needs to change. It's complicated and it does have to be done in a trade and policy level because it can't be done at an individual company level. It's very difficult, but we certainly agree that it's not right. The Americans, American consumers should not be paying for all of the innovation. The solution is simply not to lower cost -- prices in the US without some calibrating in Europe because then there'll be no innovation. But the answer to your question is I don't have any unique insight because my first name was used.

Question: Tyler Van Buren - TD Cowen - Analyst : So there's a great quarter-over-quarter rebound in EYLEA HD. So curious to hear what would attribute that to. And regarding the (inaudible) site inspection issue, can you provide additional color on the nature of the issue? And if there's present for how long it might take to resolve it or how long the potential HD approvals will be pushed back by? Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder I'll let Marion get into more details about the -- what was driving the quarter for HD. In terms of Catalent, really need to direct those calls to Novo. What we can say in a broad sense that these were not structural changes that are being requested by the FDA. It's not like they have to rebuild something or something of that. They're mainly process procedural, those sorts of things. As we said in our remarks, we do think that they'll provide a robust response. Novo's CEO wrote directly to the FDA and said they're going to elevate all this to the standards of Novo. I believe that we may not be the only (inaudible) because they do -- as I said, they do work for virtually all the bio-pharmaceutical companies. They filled, Catalent filled in its fiscal year '24, something like 70 million or 80 billion unit doses. So I think that this has a good chance of being done expeditiously. But more specifically than that, it's a little early. When we know a little more, we'll get that information out to you. I'll turn it over to Marion to comment on driving of sales for HD.

Question: Christopher Schott - JPMorgan - Analyst : Just a couple more EYLEA ones as well. Just on the PDUFA beyond the manufacturing dynamics, is there anything else pending with these three filings based on your discussion with FDA? Or are you otherwise confident that once the manufacturing is addressed, we'll be seeing approvals here? And just the second one, two-part on EYLEA. Just can you talk a little bit about the branded share erosion you're seeing in the category to Avastin? Is that starting to stabilize at all? And how quickly do you expect to recapture some of that lost share once the affordability issues have been addressed. Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 01, 2025 / 12:30PM, REGN.OQ - Q2 2025 Regeneron Pharmaceuticals Inc Earnings Call Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder Yes. So I'll comment on the PDUFA and Marion to comment a little bit on the share issues. As far as the PDUFAs go, based on our discussions, we believe that there's nothing significant left to be done. Obviously, some details, but we are expecting once the resolution of the filling issues has occurred to receive favorable action, we hope from the FDA.

Question: Geoffrey Meacham - Citi - Analyst : Morning, guys. Long-time listener, first-time caller. Thanks for the question. Len upfront. Internal R&D is really the best use of capital. You got 45 assets already in development. So what's the ROI calculus on how you guys are prioritizing? I wasn't sure if our licensing non-core assets is reasonable, especially given the innovation as a premium now? Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder Geoff, it is for first time, call, it's a good question. I think we certainly have a broad and big pipeline. We have discussed whether or not on occasion, it makes sense to turn over some of those assets. We've done that with our IL-1 blocker and seen pretty good results from our partner who has driven results in pericarditis, which is going very well. We do think there is a potential, but there are some areas where you don't want to do one-offs like oncology, I think what you heard from George, is that part of his original strategy was to have a menu of agents that might be useful to combine. So we probably wouldn't want to do something in that area. But it's a fair point, and we do spend a lot of money on internal R&D, and if it makes sense to partner or out-license, we're certainly not structurally adverse to that.

Question: Carter Gould - Cantor Fitzgerald - Analyst : Good morning. Thanks for taking the question. I know it's only been a month since you formally launched the matching program with Good Days, but can you help us think about if there's been -- if you've delivered any matching fund yet and the extent to which you expect this to, I guess, return as a tailwind to your commercial performance in the back half of the year? Thank you. Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder I think it's still early for the program since it's only been in place for about a month. And therefore, I don't think we have any useful information to share. We'll get to that later this quarter or at the end of the quarter. But we haven't heard through the grapevine of any major contributions yet. But we're watching this space very closely. We really do hope that our contribution in a matching form will stimulate others to contribute. But thus far, we don't have a lot to report.

Question: Cory Kasimov - Evercore ISI - Analyst : Good morning, guys. Thanks for taking the question. Curious as to your thoughts on the competitive OX40-ligand data shared thus far and how you believe this potentially competes with Dupixent's overall profile? Thank you. Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder George, do you want to cover that?

Question: Evan Seigerman - BMO Capital Markets - Analyst : Hi guys. Thank you so much for taking my question. I want to touch on some thoughts around MFN. So with some of your key products marketed outside of the United States by partners, specifically European partners, what mechanisms or abilities do you have to impact pricing OUS? Is there anything you can really do to force a higher price from a partner? Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder Yeah. It's a great question. I think that one of the issues and that new contracts will -- since this is going to apply mainly to new drugs according to the letter -- Dear Len Letter, as it's being known in the industry now. The Dear Len Letter suggested that you have to do this on new products, it's not an old products. And one of the reasons may be because of that complication. I suspect a lot of new contracts we'll have to deal with the contingency of what happens when -- if you license something to Europe. But Evan, it's really a great question because, for example, we don't control the pricing of EYLEA outside the United States. That's controlled by Bayer. So these are some of the wrinkles that are going to have to be figured out. Thanks for pointing that out.

Question: Akash Tewari - Jefferies - Analyst : Hey. Thanks so much. On Pavblu, we were internally going to see the ASP decline to kind of reflect Amgen's volume-based discounts and we felt like that would then, in turn, drop physician demand like we've seen with Cimerli. Interestingly, the ASP actually hasn't declined that much, REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 01, 2025 / 12:30PM, REGN.OQ - Q2 2025 Regeneron Pharmaceuticals Inc Earnings Call suggesting Amgen may be offering deferred discounts. So for the Regeneron team, how does the prolonged run rate for Pavblu impact your outlook for EYLEA? You mentioned continued decline. And number two, are there any options you're exploring here to combat this strategy? Thank you. Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder I don't want to get into practices that some might deem inappropriate, in terms of deferring of rebates. But that's something we're sort of looking into as to whether that is driving some of their success. At the end of the day, you have a product that globally has probably had something like 100 million injections. It's not just the product, but it's also the surety of how you make it and how doctors trust it and so on and so forth. But Pavblu is a competitor, and we're out there. We think that HD is the real answer to that. And as many people has experienced with it, we think that's going to be a much preferred drug than EYLEA or Pavblu.

Question: Terence Flynn - Morgan Stanley - Analyst : Great. Thanks for taking the question. You mentioned in the fianlimab first line melanoma study that the event rate is slowing. So just wondering if you could speculate on reasons there and just speak to your confidence level in showing a positive readout here and remind us what the efficacy bars that you're looking for and hoping to show. Thank you.

Question: David Risinger - Leerink Partners - Analyst : Thanks very much and thanks for all the updates. I guess my question is for Len and George. So there's a tremendous disconnect between Regeneron management's view of its pipeline and Wall Street's views. I think that the company is spending about $5 billion a year on R&D and 2032 consensus pipeline estimates are about $3.5 billion. So maybe you could share some light on the event path ahead for Regeneron to shine better light on the commercial value of its pipeline? Thank you. Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder Sure. David, thanks for your question. It's a fair question. I think I would say two things before turning it over to George. First, I would say that history frequently is a good indicator. Our research organization has produced two of the most important drugs in the history of the industry, including EYLEA and Dupixent. And I think that that's the first thing I would say. The second thing I would say is that you should perhaps listen very carefully and maybe George can reiterate some of what he said on the call today about just as an example of one area of our pipeline, which was really new and exciting on these data in early-stage myeloma, (inaudible) myeloma and early-stage DLBCL lymphoma are really quite, quite encouraging for us and we are going full steam ahead into myeloma. We're going to probably have somewhere in the neighborhood of eight different Phase 3s going by next year. That's a $30 billion market. And it will grow substantially as it moves into the premalignant stage. Big opportunities. So George, you want to add anything there?

Question: Alexandria Hammond - Wolfe Research LLC - Analyst : Thanks for taking the question. And I got a lot of focus on the pipeline, to Len's point. So one of the lesser talked about programs is Regeneron's (inaudible) readout in gMG. So as that readout approaches, can you just remind us again of the bar for success? I guess, what do you think you need to be commercially successful there? Thank you.

Question: Brian Abrahams - RBC Capital Markets - Analyst : Hey. Good morning. Thanks for taking my question and, congrats on the quarter. On itepekimab, just wondering if you had any new insights on why the AERIFY-2 study didn't hit its primary endpoint and the feasibility of mitigating that in future studies? And then maybe any potential adjustments you may consider to the ongoing studies in other indications? Thanks.

Question: Salveen Richter - Goldman Sachs - Analyst : Good morning. Thanks for taking my question. With regard to business development, you spoke to the flexibility today and the fact that you're considering differentiated later-stage opportunities in areas with high unmet need. Can you just help us understand how you think about that in the context of your overall business? Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder Yeah. We spent a lot of time looking at a lot of things. And one of the metrics that we're developing, which we hope maybe some analysts will adopt and investors might adopt, is combining the money spent by a company in research and development and acquiring research and development through a variety of deals, transactions, acquisitions, licensing, milestones and so forth. And I think you might find out and you might be surprised that we don't spend that much more, perhaps, on overall acquisition of products through research. We just spend more of it internally because our research efforts are so productive. But once again, we want the best stuff for patients. And so we go outside and look and look and look. And occasionally, we do find stuff. And if we have to do it, we have a lot of flexibility to do it, Salveen. But we don't -- to us, it's not a lifeline like it is for so many companies. And even though people think it's their lifeline, I think more often, they're pulling on threads and it's not really pulling them up anywhere because it's very hard to be successful buying things from the outside where you really don't know all the nitty-gritty, warts, and so forth. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 01, 2025 / 12:30PM, REGN.OQ - Q2 2025 Regeneron Pharmaceuticals Inc Earnings Call But having said all that, every day, we approach it with an open mind, and look at tons of stuff.