I think we're gonna go ahead and get started. Thanks everybody for being here. My name is Chris Raymond. I'm one of the biotech analysts here at Piper Sandler. Welcome to the thirty-fifth annual Piper Sandler Healthcare Conference. It's my pleasure to introduce our keynote company for today, Regeneron Pharmaceuticals. Joining us, we have Regeneron's CFO, Bob Landry, along with Ryan Crowe, who heads up the investor relations effort at Regeneron. So just some logistical housekeeping issues maybe to cover. First, I wanted to thank, however, Bob for being here. I think this is likely your last investor conference before you formally work on your pickleball game and golf game and anything else you wanna do. Well-deserved and really enjoyed working with you the last several years here, appreciated. Maybe just to go over the format, we'll have a couple of minutes of introduction from Regeneron, some forward-looking statements, et cetera, and then we'll go into a fireside chat format with some more formal Q&A. I wanna keep this as informal as possible, so if you guys have any questions, raise your hand, I'll make sure it gets asked. If you don't wanna do that, just email me. I'll be checking my phone here as we go along. So maybe first, Ryan, if you wanna start with the forward-looking statements and then a quick introduction. Thanks for having us, Chris. Thirty-fifth annual, thirty-five years Regeneron's been in business. It was founded in 1988 as well. So, thanks for having us. Always great to be here. I'll just do this forward-looking statement, and we'll get started. I'd like to remind you that remarks made today may include forward-looking statements about Regeneron. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in such statements. Description of material risks and uncertainties can be found in Regeneron's SEC filings. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. Bob? Great, Chris, thank you for that warm introduction, and happy that it's with you as my last kind of stage appearance. So, 2-minute kind of recap, just to reset everybody. Had earnings kind of first week of November, and we were very, very pleased with earnings, you know. So we had a 15% top-line growth on net revenue. We had 4% EPS growth on the bottom line. We did have a $100 million IPR&D charge as a result of a payment we made to Alnylam with the success of our ALN-APP drug that's in phase I. And, you know, if you exclude that, I think we were up 11% with regards to EPS growth. All good. High-dose EYLEA got launched in the third week of August. I know there was a lot of a lot of attention paid to that, and we were pleased with the $43 million that we registered within kind of the first six weeks. That bodes very well for the drug, and it's off to a great start. I'm assuming we'll talk a little bit about that today. Also in the third quarter, we had good PULSAR data with regards to wet AMD. That's our two-year study that showed how good this drug is really gonna be in the VEGF category. We had big news yesterday, if you were paying attention. We got DUPIXENT got the COPD kind of interim analysis review, in which we are hastily, with Sanofi, going to file an sBLA by the end of the year. And again, this is an accelerated approach. As you know, we took an interim look, and all things were positive on that. In fact, the BOREAS trial was, with regards to exacerbations, the data was really fantastic. So this is gonna be our sixth indication with DUPIXENT, so the teams are working, working hard to get that filed by the end of the year. We have EoE, peds, PDUFA date, end of January. Again, just kind of another layer on the DUPIXENT story. All good on that front. With regards to HemOnc, so we are gonna become a HemOnc player, and it's gonna start with a PDUFA date with regards to our CD20, CD3, and lymphoma diseases, and that's gonna be March 31. So again, something to pay attention to. The team back in Tarrytown is working hard to make sure the filing for our BCMA drug is gonna be in place by the end of the year. Again, that's exciting. We're hoping for that to be kind of a late summer launch in HemOnc. So again, a lot of things happening at Tarrytown. We're very pleased with how things are going. Okay, Chris, with that... Yeah. So with all the activity, I've got about 2 hours' worth of questions, and I'm gonna try to boil down to 15 minutes here. So let's maybe just jump in. Sure. Maybe some CFO questions, if we can start. Sure ... with that. So maybe just, on the leverage, in just noting this, the Sanofi collaboration, you know, begins to provide significantly more P&L leverage once you guys repay your R&D obligations. I know you've talked about this. You signaled this pretty strongly to the Street, but by our reckoning and our model, anyway, this begins in 2026. Yeah, I think you guys noted, or you noted, Bob, on your last quarterly call, that that obligation is now just $2.5 billion. In your view, does the Street fully understand the magnitude of this, of this benefit, you know, in terms of what it means to your P&L? Chris, I think they're coming around. I think analysts are beginning to do a good job with regards to capturing this. And again, you know, to put a little background on what Chris is talking about, we have an off-balance sheet liability of $2.5 billion that has accumulated over time with regards to the development of DUPIXENT and PRALUENT and KEVZARA and linvoseltamab, in which, you know, we were in a 50/50 relationship, but we haven't been funding on a 50/50 basis. As a result of that, a development balance, off-balance sheet kind of builds up, and it's at $2.5 billion, and it was roughly, you know, let's say, $2.865 billion as we started the year. And we're continuing to pay this down, and we're paying it down based upon a percentage of the profits that we earn on DUPIXENT each quarter. Now, what Chris is referencing is eventually this will be paid off, and it will be a significant inflection to our earnings, to our margins when that time comes. As you heard Chris say, he's got 2026. You know, our last qualitative comment was basically in the next few years... certainly with the data coming from BOREAS, the COPD trial, if we can get that to market sooner, given the patients and, you know, the patient count within the COPD indication, we hope for that to be as soon as possible. So Chris, I do think people are coming around on it, and that is a big earnings inflection point for Regeneron, when we no longer have to pay. By the time, you know, at the end of that transaction, we could be paying somewhere between, I don't know, $600-$800 million to Sanofi on it. And again, that will kind of magically go away once that balance is paid off, and that profit will drop to the bottom line. So again, important to have that in your models- Yeah. Pretty directly going forward. So, there's another question I know you guys get a lot, and I'm gonna try to ask it in a novel way. But, on capital allocation, you know, you guys ended the quarter, third quarter with $13 billion. I think net cash of $13 billion. You're throwing off, you know, $1 billion-plus per quarter. That's you know, arguably accelerating, at least, you know, by our math. We have the business amassing some $28 billion or so in cash by 2026, unless, you know, something dramatic changes. So you know, again, I know you get this question all the time, and I've heard your answer. It's pretty consistent that you guys invest in R&D, and, you know, you, you've done a lot of very consistent deals, I think, in terms of, stuff that complements, you know, the science focus of the company, which is all great. But, you know, maybe more pointedly, you know, as I've seen Regeneron, evolve in your tenure, Bob, you know, you guys have gone from, "You know, Regeneron does not provide guidance," to, "You guys do provide now," you know, some guideposts anyway. You know, stock buy repurchases were not a thing, and now that's clearly, you know, part of your plan. You know, even with a steady state of tuck-in deals, you, you're going to have, you know, this enormous cash benefit potential, again, unless something dramatic changes. At what point, I guess, does it make sense to start talking about a dividend? Yeah, Chris, thanks. And we do get that question a lot, and, I mean, it. We are in a super envious position with regards to the strength of our balance sheet and the optionality it provides. You know, our job as kind of CFO and the management team is to make sure that we use it correctly. We've gotten a lot of kind of questions recently from our largest shareholders with regards to dividends. And again, these are shareholders that have kind of a fund-of-funds with regards to many funds under their umbrella, and they would love to open up Regeneron to more than just kind of growth funds or non-dividend paying funds. So that's where the pressure has come. So we took it upon ourselves to do a super deep dive, beginning in the summer between the IR department and the Treasury Department, and we brought in kind of three investment banks to kind of get their feeling with regards to what the timing is on this. And, you know, we used Amgen and Gilead as kind of analogs. You know, we did all this work. Again, I talked about this development balance inflection coming, you know, in the next few years, and the decision was, you know, not right now with regards to dividends. You know, I find it hard to kind of launch a dividend program when, you know, yields are at kind of north of 5%, when you probably can't give anything more than, you know, 50 bips or 75 bips, but, you know, that would be for a later date. So, you know, it's kind of on the horizon. You know, the new CFO in determination with the board and the new CE, and the old CEO, Len Schleifer, they'll make a determination on when timing is appropriate. But again, we are getting a lot of pressure on that front. And, you know, I personally think that it's probably in the foreseeable future in which Regeneron will become a dividend-paying stock. And again, to what Chris said on capital allocation, you know, not to make any kind of new news on my last kind of stage appearance, you know, we are gonna continue to invest in R&D. We're gonna drive that hard. We got 36 assets in the clinic. We have more and more, you know, INDs being put forth kind of every year. BD will continue to do tuck-in deals. Tuck-in deals may get a little bigger than what we've been doing with regards to Checkmate and Decibel. And then buybacks. You know, we've been kind of riding buybacks pretty hard. I think since our launch in November of 2019, we bought back $11.7 billion of stock. We did it at a handle of 555. We're pretty scientific. We do a lot of intrinsic valuation with regards to where we are buyers as compared to what the stock price is. So again, that's played, that's played pretty favorably, and you'll continue to see that coming out of our repertoire, going forward. Excellent. Okay, so let's maybe jump into some of the commercial push-pull, sort of dynamic. So maybe on, on EYLEA and the ophthalmology business. So, you guys had a really nice initial print for the 8-milligram, you know, the high-dose format for EYLEA. And I know you guys haven't wanted to give a ton of color, you know, in terms of patients, the source of patients or sampling efforts. I know you've, you've- Marion did mention that some of the patients, in that initial print for the HD format came from Avastin, some from the Vabysmo and so, and, and others. But it just... You know, from our survey work, at least, it seems that, it's not a one-for-one, you know, sort of switch. It's not just a cannibalization, and you're gonna switch out all the EYLEA patients for EYLEA HD, that there's a net gain for the franchise. I've spent the last couple of days getting calls from investors who are needling me for my street high estimates for this franchise. And noticing, actually, through some of those conversations, that there's a huge variance in terms of what people are modeling. And I know... Again, I know you guys don't give revenue guidance, but that seems to be, especially in 2024, like, we're talking $2.5 billion or so from high to low. At some point, does it make sense to provide at least some sort of guardrails, at least for folks? Especially as this important conversion of the market. Yeah, Chris, as we approach year-end, I mean, we'll see where the models are. It's probably unlikely that we're gonna do that. Again, I'll leave that to the new CFO working with Dr. Schleifer, in terms of what the approach would be. You know, I mean, it will be our job to make sure that we kind of message where this is going. We may not give kind of exact figures, but again, you know, we don't want it to be so asymmetric with regards to where things are going to play out. And with regards to high dose, you know, we think it's off to a great start. So, thanks, Chris, for saying that, you know, how good the print was. And again, you know, we're getting patients from kind of all over. We're getting kind of switches, naive patients, and recalcitrant patients, which is good, and it's coming in both wet AMD and DME, the two big indications there. And, you know, as you can expect, you know, Ryan and I, we kind of put our ears to the ground. What are we hearing from physicians? And, you know, we're at the stage now that we're having a lot of patients come back for kind of dose number two and dose number three. You know, we're hearing really good case studies about how, you know, physicians are having their, you know, recalcitrant patients come back, ones that they could never get dry, and probably those that were the frequent flyers, and they're seeing dryness for the first time, which is really kind of fantastic news, and I think that bodes well for kind of the future of, of the franchise. And Chris, to your point, you know, I talked about, you know, our buybacks. It's done on our intrinsic valuation. And I will tell you, and I got asked this question yesterday by someone: Where is the greatest separation between, you know, my intrinsic valuation and where the street is? And I would say it's the EYLEA franchise. You know, without getting into, without getting into specifics, I mean, we, we do not have, you know, the declines that we see within the franchise as that's coming out of the sell side reports that are there. Most of the sell-side. Most of the sell side. All right. So cool. Maybe one more sort of, EYLEA or ophthalmology question. So we've seen a lot of players sort of come and go. We've seen gene therapy approaches, sustained delivery of TKIs, you know, a bunch of different modalities. And to be fair, there's still a few standing, sustained delivery TKIs that are out there. But when you guys think about the landscape competitively, and you think about maybe five years from now, is there any modality, that you view that could be a game changer, that has maybe George, you know, up all night worrying about? I think George stays up all night worrying about a lot. But I don't think that we see anything really across the spectrum of ophthalmology and retinal disease therapies that is going to disrupt the current treatment landscape, which is focused on anti-VEGF. And we certainly keep our eyes on all of our competitors and all these competing modalities and gene therapies and implantables and sustained delivery. And, you know, I think our view is EYLEA HD addressed the primary unmet need in this space, which was duration. And Bob mentioned the PULSAR study. In the second year, by the end of the second year, almost half, 47% of patients were eligible for every 20-week or every 24-week dosing. That's pretty good, you know, when you're down to two or three injections per year, and I think doctors are going to want to see their patients at least a couple times a year to ensure that vision is not being lost, that they're not seeing fluid reaccumulate. So I think the unmet need has been met with EYLEA HD in large part. I'm interested to see how some of the science works out with some of these other modalities and mechanisms. But again, I think we've seen some implantables that have gone, that have tipped over. You know, I'm thinking of Susvimo. But we'll see how the others work out. To me, though, I think we're very comfortable with where EYLEA HD sits currently and in the future, and for retinal disease treatments. Okay, so one more ophthalmology question, and this is a topic that I'm actually kind of surprised it doesn't get more airtime. You guys allude to this and talk about it. It's your geographic atrophy program. And for folks who might not be aware of this, I know you guys talk about pozelimab and cemdisiran as a combo, IV combo, in geographic atrophy. You know, I think, you know, Ryan, you've articulated, you know, a plan to potentially be able to to start a phase III or a phase II/III trial- Yeah ... early next year. You know, this kind of intrigues me. You know, without really, you know, any human data, what is... First of all, what's the, the communication plan, I guess, of this, you know, in terms of what data you have that supports, you know, jumping into a, a later stage trial like that in, in such a time, such a fashion of timing? And, and maybe just give a preview of what you, how you plan to talk about this program. Sure. Yeah, it's very interesting, and I think we have some good tools to potentially address this disease, which the exact cause is not even really known, but it's believed to be complement-mediated. And the current therapies that have been recently approved by the FDA look to localize. They look to regulate complement in the eye with either C3 or C5 inhibitors. Our approach is going to be different, and it's going to be a systemic delivery, but it's going to be an every four-week subcutaneous, self-administered injection. So we are not looking to put any needles in eyeballs. This will be a self-injection every month. And the data that we've accumulated is in a PNH population, where we've seen rapid, complete, uninterrupted knockdown of C5. And the siRNA component of the combination kind of stops the manufacturing of C5 protein in the liver, where the majority of it is synthesized, and the antibody piece knocks out the circulating C5. So we hope to share that data very soon. I think everyone will kind of say, "Wow, that's an impressive knockdown." And we compared it against ravulizumab, and that's kind of considered the standard of care today for C5 inhibitors. And so we're looking forward to sharing that. And I think once people see that data, they'll understand our excitement around potentially developing a geographic atrophy asset, but also about the combination of other siRNAs and other antibodies for other disease types. So it really could open up a whole new flank for approaching different diseases that are currently have high unmet needs. Excellent. Okay, let's pivot in the minute and a half we have left, to Dupixent. So I had a bunch of questions here just asking about the risk-reward of taking the interim look on NOTUS. So, obviously, that's a foregone conclusion, and congrats on- Thank you ... on the data, and that's, that's just amazing. Maybe just a commercial question. I know you guys have said sales coverage isn't really an issue here since you already have the right folks on the ground. Maybe talk about- Mm-hmm ... the sales force allocation plan going forward, you know, assuming, you know, the regulatory path is what it looks like it should be. What activities you need to draw from to support COPD. I know you mentioned that a lot of education is required because docs aren't really used to, you know, biologics in this space. Yeah. I don't think we're gonna talk directly about how we're gonna allocate the sales force, but what we do have is an asthma sales force that's been on the market for several years and knows all the pulmonologists, and there's a lot of prescriber overlap between COPD and asthma. And I believe we're gonna be leveraging that sales force to launch the drug. I think we'll have a lot of success there. And I'd add that, you know, the results of NOTUS at a 34% reduction in exacerbations really affirm the high efficacy bar that was set by BOREAS, where we had a 30% reduction in annualized exacerbation rates. So this is a disease that has no available biologic therapies. Hopefully, DUPIXENT is the first. We plan to file by the end of the year, and with a priority review, could be approved by the middle part of next year and pulling forward that approval by at least six months, where we were previously expecting final results at the middle part of next year. Mm-hmm. So very excited to be bringing it to patients sooner. Yes, there was a little bit of risk involved in the interim analysis, but we had confidence that DUPIXENT would deliver, and it sure did. Okay. All right. Actually, we have more time than I thought. Our clock just started working back for five minutes. Oh, good. Anyway, so here we go. So maybe with that time, let's talk about atopic derm. Obviously, you know, a massive source of growth still with the new patient dynamic. But you, having invented essentially the market, you, as you guys have, you know, what is natural is you see a flow of competitors. You know, I think you talked about, even with the growing number of MOAs in the space, you know, exploring a combination strategy with DUPIXENT is not a priority. You know, dermatologists, however, do tend to like combination strategies, or approaches. Walk us through maybe sort of the remaining growth levers in atopic derm. I know you have expansion into the younger populations, and there is a rising tide, if you will, of new patients coming to therapy. Although interestingly, you know, from our work, atopic derm patient load within the physician office is, like, more than psoriasis now. How much more growth is there, you know, from some of these traditional levers? Yeah, I mean, that's the beauty about DUPIXENT, you know, five indications with a sixth indication coming. And then our largest indication, as Chris was alluding to, is AD. You know, we were talking yesterday with an investor, and we told them that, you know, within the AD category, it's not even a teenager yet, meaning that it hasn't even gotten to 13% with regards to penetration, and we think it can go to 25%. So, you know, just on the penetration alone. And think about it, I mean, it's the largest indication on a drug, you know, that's annualizing greater than $12 billion off of our latest quarter. And within the largest indication, we're not even kind of halfway there in terms of what we think we can do with regards to penetration. And I think psoriasis, as Chris referenced, is a good reference point to that. And then, you know, I mentioned in my opening comments, you know, that we have kind of, more indications coming for this, but certainly in the earlier age groups. I mean, to think that you can give a biologic to a six-month-old, you know, that, that's kind of unheard of. You would have never thought that, you know, a couple of years back, when we were able to get that indication. So there's still more and more and more younger kids, either peds or adolescents, that are, that are coming into the kind of this AD category. And then, you know, like with any indication, you start with your most severe, right? So from moderate to severe patients, you know, and we're taking care of the severe, but we do think there's just a whole host of other moderate patients that can kind of come into this category. So, you know, Sanofi and Regeneron, you know, we're far from thinking that, you know, we're done with regards to AD. We still think there's a ton of additional penetration that can be had in that marketplace. All right, one last topic, and it's a big one, obesity. So George has talked rightly about, you know, while GLP-1s are obviously revolutionary, there are some shortcomings as you start to see more patients coming off therapy, the lack of lean muscle or the loss of lean muscle, you know, is likely to be a more front and center, you know, sort of societal issue, I would argue. And I think you guys have been pretty vague about the clinical setup here. You've got a myostatin blocker, an activin A blocker. Maybe just give us a sense of, you know, the news flow and the clinical path, how you might define that. You know, maybe a Part B to that question, you know, obesity trials, obesity development is not a trivial, you know, spend proposition, you know, enough to give a CFO, you know, a lot of heartburn to think about - that kind of heavy lift. Is this some area where you think a partner actually might make sense? I'll start. Maybe Bob will add on that last bit. But for us, you know, we ran a study on obese non-human primates, and I think the next step, and we saw a lot of great results, which I'll discuss in a moment. The hope is we will launch a study early next year to hopefully replicate those results next year in obese people. So the non-human primate data that we presented at ADA this year combined semaglutide with two of our antibodies. One's a myostatin antibody called trevogrumab, and then there's an activin A antibody called garetosmab. So what we saw with these different arms of this study in these obese non-human primates was greater fat loss in both the activin and myostatin combination arms, combined when combined with semaglutide. In fact, in the myostatin semaglutide combination, they lost more weight, and it was all fat. They retained the lean muscle mass returned to baseline by week 20. The activin A component adds muscle, so the weight loss results were not as impressive over 20 weeks. But we think with longer duration, potentially higher metabolic rate with muscle, you could end up in the same place as a GLP-1 alone. So we're excited about what we saw in the non-human primates. We're gonna be launching a clinical study of these different antibodies with an incretin backbone early next year. And once we understand how this manifests in people, we'll go from there. A partner, I think, could make sense. We're certainly not averse to partnering with leaders in the space, but first, I think the goal is to figure out if these antibodies have an application in the obesity category. Awesome. Okay, well, we're out of time, so, please join me in thanking Regeneron for that great-