Regeneron Pharmaceuticals Inc Q3 2025 Earnings Call Transcript

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

Question: Akash Tewari - Jefferies - Analyst : Hey. Thanks so much. It seems like your team has retooled your commercial strategy on EYLEA and it seems related to kind of price. What are you doing on a ground level when it comes to volume-based discounts it's allowing you to take share from Roche and Amgen? And are you seeing more price erosion on EYLEA? Are we also seeing that discounting on high dose? And maybe just lastly, should we continue to see volume gains and revenue gains ahead of the label enhancement potentially midyear? Thanks so much. Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder Well, I think you may have set the record for the number of questions we're not going to answer. Not because we don't want to, Marion would love to, but I think that there's so many competitive issues ongoing there in terms of our strategy on the ground, our rebates, and so forth. So I'm not sure we're able to really help you out there. Marion, I don't know if you want to add anything?

Question: Geoffrey Meacham - Citi - Analyst : Morning, guys. Thanks for the question. I guess for Chris or Len, I'm utilizing the balance sheet, you guys haven't historically done larger scale BD and it seems like that's going to be the case going forward. But in manufacturing, what's the appetite to further expand your plans that you've announced just so you own all elements of manufacturing? Obviously, that would be viewed pretty favorably by the Trump administration as well. Thank you. Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder Yeah. Great question, Geoff. Just on whether or not we would use our balance sheet for large deals, we certainly have no allergy to doing that, if we saw the right opportunity. So it's not a question of philosophy there. It's really a question of what would make sense where we think we could create additional value. In terms of investing further in manufacturing, and as I said during our (inaudible), we've been talking about the need for domestic manufacturing since 2014, I think, in testimony before Congress. We mentioned the over $7 billion investment plan. But I think you do highlight one piece of the whole puzzle that we do not have adequate positioning in is the filling. But I'm pleased to say that we would expect our filling plant to come, which we've invested quite a bit in, Geoff, it's now ready to go, and we expect it to come online during the coming year. So that's a great question, and it should help us sort of control all aspects of the standard biologics manufacturing.

Question: Chris Raymond - Raymond James - Analyst : Thanks for taking the question. It's maybe a question on EYLEA HD, Marion, I think I've heard you talk a lot about the importance of the labeling enhancements and Len, I just heard your comment about share and how important they are. But I think we've come to understand maybe the REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 28, 2025 / 12:30PM, REGN.OQ - Q3 2025 Regeneron Pharmaceuticals Inc Earnings Call primary need here and the reason for these enhancements and why they're important is for certain clinics to have dosing flexibility so they can center their inventory around one drug. But just maybe, Marion, as you've seen this market evolve, can you talk about how that clinic inventory policies have evolved over time and especially how private equity in the space may be influencing this? Or is this really more of as you're looking to share with clinics that don't necessarily have relatively aggressive inventory policies.

Question: Terence Flynn - Morgan Stanley - Analyst : Hi. Thanks for taking the question. George, you mentioned, it sounds like, likely, you and Sanofi are going to do another Phase 3 trial here for IL-33 in COPD. Can you just talk about any new insights you might have learned that drove the differential outcome in the prior two Phase 3 trials? And then what you think you can change or optimize in a third trial here to improve the likelihood of success? Thank you.

Question: Tyler Van Buren - TD Cowen - Analyst : Good morning. Congratulations on the quarter. Can you elaborate on the probability of the late December decision on the RVO and every-four-week dosing filing with the new filler resulting in an approval? And just a quick follow-up would be, is this the same alternate filler that you use for the recent Libtayo adjuvant cutaneous squamous cell carcinoma approval? Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder No, it's a different filler. It's a complicated sort of timeline here. Because the new filler has to undergo its review and it probably in an inspection and review, and it's unclear when that would be done. Ideally, if that could get done before our November timeline for the approval, for the PDUFA date for the RVO q.4., that would really be perfect, and we could get it all wrapped up in late November. If it turns out that they have to go to December to get the filler approved, hopefully, that would be as far as they have to go. But of course, the FDA looks at all these things pretty carefully. This filler has a very good track record, but it's got to undergo the inspection and so forth. So I suspect that If they got through that in December, then we could rapidly resubmit or maybe the application would still be on file, we don't know exactly. We're going to have discussions with the FDA. But we believe that there is nothing left to do on that application other than to get the filler in place. So we think we've had very good discussions about label and indications and all, that's fine. But it's not over until it's over, obviously. But ideally, to summarize, if we could get the filler online before the late November date, it could all be wrapped up then. If not, we would expect and hope that that filler would get approved in December. And then rapidly, we would immediately resubmit and the FDA hopefully could act immediately. That's to-date that we can tell you.

Question: Evan Seigerman - BMO Capital Markets - Analyst : Hi, guys. Thank you so much for taking my question. Just taking a step back, can you walk me through some of the internal changes you've made with your regulatory manufacturing teams to prevent the CRLs that we've seen of recent and ensure that products that should be approved get approved and get the patients as quickly as possible? Thank you. Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder Now that's a very pointed question. And I really want to address it head on. The issues that we have had have not been internal regulatory problems. We have a terrific relationship with the FDA. Our regulatory team includes people who used to work at the FDA or people who've been in the industry doing this for decades. There's no shortage of expertise or relationships on a regulatory front. We've certainly asked that question, the Board always ask that question, and there's no issue there. On the manufacturing front, we recognize that it would be more ideal if we could have our own filling. We would have expected to have that by now, but we got delayed dramatically during COVID because of supply chain issues in manufacturing. As I said, we hope that filling will come online next year. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 28, 2025 / 12:30PM, REGN.OQ - Q3 2025 Regeneron Pharmaceuticals Inc Earnings Call In terms of getting backups and what have you, it's a relatively complicated situation. We've been working on backups for quite a long time now. The problem, as you might imagine, is that, for good reason, the FDA is very finicky about showing where you make, what's going to make the product, literally, what equipment it's going to touch, and then you have to do stability testing, and quality testing. All of that for a given filler. And that takes quite a bit of time, quite a bit of resources. So in summary, I don't want to sound offensive at all. We have looked at this. It is not a regulatory problem for us. It is, in some respects, a manufacturing issue in terms of getting online our own filling. Having backup fillers in place is complicated, we're trying to do that. But our biggest problem, frankly, is the FDA has now paid quite a bit close attention. And I might point out that the biggest companies in the world have had the same issue with fillers where even with the same filler, and they've called us to know how's it going? But they just don't talk about the CRLs that they get, and we know that they're out there. So I'm not sure that we're worse off in that regard. But wherever we are, I'm not happy about it and we're not happy about it, and we're trying to rectify the situation. I hope that gives you a glimpse into our thinking.

Question: Brian Abrahams - RBC Capital Markets - Analyst : Good morning. Thanks for taking my question. Just on the pipeline front on the Factor XI antibody program. I don't want you to front run your roundtable, but I know you guys recently started large Phase 2 study for the antibodies in afib. So I'm just curious what you guys are looking for out of that study and maybe out of other Factor XIs in development to move into registrationals in that and other large indications and really accelerate that program? Thanks.

Question: Carter Gould - Cantor Fitzgerald - Analyst : Good morning. Thanks for taking the question. Len, you highlighted the sort of the meager matching thus far with the foundation and I guess you framed it remaining committing to that funding until the end of the year, which I guess sort of allude to a potential terminus. At some point, maybe at the start of the year, does it warrant taking a different tact if you don't see any other people match your commitment? Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder Yeah. I mean, I'd like not to tell people don't bother to make a commitment because we're going to take care of it. That's not our approach. Our approach will be that we will look at it fresh next year and see what the best strategy is to help patients. Good question though.

Question: Cory Kasimov - Evercore ISI - Analyst : Good morning, guys. Thanks for taking the question. So on the heels of your positive Phase 3 data for cemdisiran, can you outline how you see the commercial opportunity evolving for gMG and what your plans are in Europe with this asset? Thank you. Leonard Schleifer - Regeneron Pharmaceuticals Inc - Co-Chairman of the Board, President, Chief Executive Officer, Founder Before we get to that, maybe, George, could you just remind everybody what's out there and what the limitations of the current therapies are? Because I'm not sure everybody's on the same page on that.

Question: Simon Baker - Rothschild & Co Redburn - Analyst : Thank you very much for taking my question. My first ever question on the call. I just wanted to go back to your comments, George, on intravitreally delivered CD3. You're trying it initially in uveitis. I just wonder what the scope of your ambition was in that setting given the role of T cell infiltration in glaucoma which is, obviously, a much bigger indication. Any thoughts on where this could go will be much appreciated. 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. OCTOBER 28, 2025 / 12:30PM, REGN.OQ - Q3 2025 Regeneron Pharmaceuticals Inc Earnings Call

Question: Simon Baker - Rothschild & Co Redburn - Analyst : So there's some evidence that glaucoma is caused, greater or less part, by T cell infiltration in the eye. So I just wondered if using CD3 antibodies in this setting would potentially encompass that indication as well as uveitis.

Question: Alexandria Hammond - Wolfe Research LLC - Analyst : Thanks for taking the question. On the upcoming Libtayo LAG-3 readout, it seems like the goal is to outperform Opdualag. But could you share your confidence in demonstrating a [staph] safe benefit against Keytruda? And as a follow-up, can you tell us a little bit more about the open-label Phase 3 trial you have ongoing against Opdualag? Is it just another show of confidence that your combo can be more potent than the currently approved option? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 28, 2025 / 12:30PM, REGN.OQ - Q3 2025 Regeneron Pharmaceuticals Inc Earnings Call

Question: Christopher Schott - JPMorgan - Analyst : Great. Thanks so much. Just a quick one on the launch of linvoseltamab. Just how's that progressing versus expectations? And can you just elaborate a bit on the timelines of when you could actually get this product into some of those earlier lines of therapy given the profile that seems to be shaping up here? Is there an ability to pull that forward or accelerate that all in terms of working with FDA, et cetera? Thank you.

Question: Salveen Richter - Goldman Sachs - Analyst : Good morning. Thanks for taking my question. You spoke to novel targets here in I&I and ophthalmology, on the GA program in particular, can you speak to what the FDA may be looking for potential study designs, whether it's slowing (inaudible) lesion growth or vision improvements and whether you need to evaluate against current agents? And just remind us on the I&I side when we might hear about these novel targets. Thank you.