Regeneron Pharmaceuticals Inc at Cantor Global Healthcare Conference Transcript

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

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : All right. That's perfect. So I think as most companies, most investors were not at their desk in the back half of August, you guys had a number of data updates, which kept us on our toes. Maybe let's focus first on the MD data. So interestingly, for an asset -- set of assets that aren't really in Street models, you guys put out positive data. And I guess, first off, as you think about cemdisiran and sort of the ability -- the data, maybe help frame it as well as how you guys think about the potential to compete with the FcRns in the space.

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : And is this, I mean, predominantly just a share gain? Or is it really an opportunity to grow the broader class -- or the broader market, excuse me?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. And maybe just sticking with MG for a second. As you guys think about commercialization, this require its own separate neurology sales force, another Regeneron sales force? Or are there existing commercialization capabilities you think you'll be able to leverage?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. And maybe somewhat lost in the data or maybe lost a bit on the focus on MG is what the data of the combination arm sort of read through to PNH. Maybe help frame that for folks and why that maybe bolsters your confidence gives you -- maintains the confidence you have on the combo.

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. And that PNH study, I think it's ACES-1. Maybe just kind of where that stands and when we can expect it? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 03, 2025 / 5:35PM, REGN.OQ - Regeneron Pharmaceuticals Inc at Cantor Global Healthcare Conference

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : And I guess on the back of the MG data, are there other indications you guys are contemplating? Or should we expect an expansion? Is that fair?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. Maybe switch gears to the other bit of news that happened in late August was the updates on the PDUFA for EYLEA. So you got the three-month push. But I guess what gives you confidence we're going to get to an answer in that time frame, just given kind of how this continues to get drawn out?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. And should we still think that just level of confidence that the decisions on both fronts, both the prefilled syringe and the eight-week -- or the four-week and RVO are sort of -- will come in tandem or that it will align? Any reason why you could get a differential outcome?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. That's helpful. I guess as this started to play out over the course of the summer, it brought up this recurring question around what else can Regeneron do to maybe get ahead of some of these issues in terms of bringing different capabilities in-house, expanding, et cetera. You guys have REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 03, 2025 / 5:35PM, REGN.OQ - Regeneron Pharmaceuticals Inc at Cantor Global Healthcare Conference talked about that at like a high level, but are there specific things or efforts you could point to, to maybe underscore the point around maybe taking a different tact here than you have in the past?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. Maybe sticking with EYLEA. I think one of the key questions is, particularly after the pushing on the the action dates has been sort of the growth that you highlighted in 2Q to the extent that, that's sustainable even with the PDUFA stuff sort of PDUFA updates sort of unresolved for now. Anything you can say on that side? And just again, around the sustainability of the growth you saw kind of strong in 2Q?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Anything else you can say on that competitive pressure? I mean, obviously, we have PABlu out there, and then there were a couple of other biosimilars that got approved or launching...

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. So we got through a lot of the pipeline updates of late. Those are great questions. Those were interesting topics. But the one I really want to ask you, Chris, is the one really around sort of the pace of R&D growth here. I think investors understand Regeneron is going to invest in R&D. The track record is there. The pipeline breadth is there. The leadership has echoed that repeatedly. R&D has doubled since 2021. At the same time, Street models always seem to sort of imply this great moderation in Regeneron R&D spend that never really comes. And this is particularly before the next wave of your pipeline launches. So I guess -- to what extent does showing EPS growth in '26 influence the pace of R&D growth, particularly after '25 in which EPS growth -- EPS didn't grow. I guess it's a long way of saying how important is showing EPS growth?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. And maybe coming back to capital allocation, which you sort of teed up earlier. To what extent does having sort of better visibility on EYLEA from a regulatory perspective and some of the external uncertainties that have been hovering around the space the past couple of months I guess to what extent has that been a limiting factor in maybe making bolder capital allocation decisions, recognizing at the same time, you did buy back a lot of stock in the first half of the year.

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. Maybe switching gears to some of the pipeline -- we'll start off with the pipeline. You had a sort of a high profile miss earlier in the year with itepekimab. And I think at that time, the expectation was for any sort of path to approval was going to likely require an additional study. It seems like there's been maybe a little bit of evolution there and -- or maybe just -- maybe more openness to potentially doing that study. I don't know. But maybe just at this point, how you think about itepekimab and the path forward?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Is that something you think we'll get clarity on before year-end?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : All right. Maybe alongside that, you obviously have the Dupi COPD launch, which everybody is always slicing and dicing the IQVIA data to try to figure out how well this is going. Maybe just I'll go straight to you guys and ask you how you think about the COPD launch, the extent to which that sort of the very strong growth we saw throughout, let's call it, the past 9, 12 months continues to sustain.

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : And I think one of the things we often get questions around is just sort of the ability to continue to -- longer term, I'm not going to ask you for a market size question because you can kind of answer that. But just as you think about the broader opportunity within COPD maybe relevant to some of the other indications you've played in and obviously had success in.

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. So as we look out, obviously, Dupi is going to continue to get bigger. But there is that question around life post-Dupi. And as CFO, how do you approach the balance of the decade knowing the noise around life post-Dupi is only going to rise with the context of the company's historical track record around the name. You touched on this a little bit, but I think the question is still pertinent.

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Right. So visibility on those INDs in the next six to nine months?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : Okay. Something to look forward to. Okay. And then maybe in the last minute or so, LAG-3, you had the update, which seem to have this cautionary appendage around maybe data getting pushed into first quarter next year. I guess just bigger picture, to what extent does just the slower event rate maybe cause a little bit of concern. The Phase II data looked very strong on a relative basis to your competitor, but this event rate, to what extent does that mean sort of the underlying assumptions might be off?

Question: Carter Gould - Cantor Fitzgerald LP - Analyst : All right. Perfect. Well, there's a light blinking. I think we need to wrap up. But Regeneron, thank you very much for joining us.