Awesome. Thank you very much for joining us today. Welcome to my second session of the day. I'm Mohit Bansal, one of the biotech analysts here at Wells Fargo, and I'm joined by the Regeneron management team. We have Marion McCourt, the Head of Commercial at Regeneron, and Ryan Crowe. He heads Investor Relations. Team Regeneron has been consistent with us for the last four years, so thank you very much for being here with us.
Thanks, thanks for having us, Mohit. It's always a pleasure to attend your conference. Great venue, always great, well attended, so outstanding. I'll just read this forward-looking statement, we'll get right to your questions.
Sure.
I'd like to remind you that our 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. A 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. Back to you, Mohit.
Great, awesome. So we'd like to talk about there's a lot of commercial execution going on, a lot coming up there. So great quarter with high-dose EYLEA. So can you talk a little bit about the journey of high-dose EYLEA, the beginning, and then obviously a lot changed with the shortage thing earlier this year, and then you are reinvesting in that. So there's a lot of... There are a lot of questions there, but just talk a little bit about the journey in last six months and then the outlook as well here with the high-dose EYLEA.
Sure, Mohit. Very happy to. Good morning to everyone. I'll cover the commercial aspects of EYLEA HD, EYLEA, and then let Ryan talk a little bit more about some of the factors of affordability. But to start with, with EYLEA HD, you know, certainly last quarter, we were very pleased with sharing with you our performance of EYLEA HD, having the strongest growth in the branded category within the anti-VEGF category. We talked about demand growth in the quarter of about 16%, the prior quarter U.S. for a six-month view. If I go back a quarter, fourth to first quarter was about 5%. As we think about EYLEA HD, the trajectory of the brand, I think the most important thing I share with you is that the retina community really likes EYLEA HD. They have confidence in Regeneron, even more importantly, experience with EYLEA.
So frequently, we hear EYLEA HD is described as EYLEA made better because it really is the product that's showing that level of durability, the ability to elongate dosing intervals for patients, but still give them the efficacy and the safety that they've come to appreciate with EYLEA over fourteen years now. And, you know, so many injections in the eye, helping so many patients and across indications, giving them that ability to have confidence in their vision, their lives, and their families. What I'll share with you, though, is really exciting and we're trying to be patient. We look forward to some enhancements to our label.
You know, we do, and Ryan will talk a bit more about the timing and the expectation there, but consider that EYLEA HD performance in the category has been without a couple of key ingredients that we very much look forward to. Q4 weekly dosing is not something that every patient needs, but there's a portion of patients. For some practices, it might be 5%, others, 10%, maybe, maybe 15%, 20%. The fact is, though, the physicians don't know when they're administering product, which patients are gonna be the ones that need the shorter dosing interval. So Q4 weekly dosing is an option in the label, like we have with EYLEA. Nothing more than that. It's just the potential to use Q4 weekly dosing will be most helpful. Prefilled syringe is a tremendous convenience factor.
Our busy retina practices are treating, you know, 50, 80, 100s of patients, sometimes across a practice in a given day. Prefilled syringe will be important, and certainly, we look forward to the potential inclusion and potential approval also of the RVO indication of reference in 2024 . That was a $1 billion indication for EYLEA. So those elements are important. I would say that the way I would think of it now is I'm seeing with my team a stable, steady growth of EYLEA HD, very strong performance in what is a very competitive category. A lot of different elements going on, but a product profile that really has the opportunity to be the standard of care as we broaden the label.
That growth is notwithstanding some of the challenges that the branded category has had due to some affordability issues that have been encountered this year. The wet AMD is a disease of the elderly, and a lot of these patients are on Medicare plans and Medicare Advantage plans that require large out-of-pocket costs. Historically, some patients have relied on charitable contributions to offset their out-of-pocket costs. These charitable contributions are done by third-party foundations, and the contributions this year have been significantly lower than in years past. To help ameliorate this, Regeneron has offered a potential solution to match donations from any other donor who would like to help these patients out.
But and this was a program that launched this summer, but so far, we have yet to see any meaningful contributions that Regeneron could match. So we continue to hope that there is going to be some donations made in the second half of this year that can help these patients get the drugs that they need, because moving to Avastin is gonna lead to worse visual outcomes for these patients. It's been shown time and time again that Avastin is an inferior product that requires more frequent injections. And so these patients need the better drugs and need help with supporting them financially, which we intend to do, but with the help across the entire spectrum of potential donors.
Is it fair to say the 2Q strength you have seen in high-dose EYLEA has not, like, carried over or the new formulation has not contributed to that yet? It is mostly the strength of the product at this point.
So maybe let me take a start on that. What I would share is that the market is, you know, it's, it's complicated.
Right.
It's a large market. So EYLEA HD, as a product that's been in market now for about two years-
Right.
Is probably less impacted by the affordability challenge as EYLEA, which is a bigger product.
Right.
However, I wanna be candid, there's an interplay because EYLEA HD is a source of growth for... Excuse me, EYLEA is a source of growth for EYLEA HD, as is Vabysmo, as is Avastin.
Right.
You really can't just dissect one away from affordability, but I also would say that a larger product is gonna be appreciating a greater impact from the affordability situation right now.
Got it.
I hope that's helpful.
No, that's very helpful. Thank you.
I also will share, though, that, you know, the overall franchise performance of EYLEA and EYLEA HD, 60% of the anti-VEGF branded category, is very important, and it bodes well for the ability for EYLEA HD to continue to perform well in the market.
Got it. So, I mean, how are you seeing the competition from biosimilars at this point? So I ask this because, I mean, as... Like, people do not appreciate that this category has been actively managed with Avastin anyways, right? It's not that starting this year, it has been managed, right? I mean, there have been prior ops before that as well. So are there prior ops there with EYLEA biosimilar? Or, like, what... How are you competing against EYLEA biosimilar, which is a very good product, actually?
I would say the market, again.
Yeah.
D ue to complications in the market at this time, at this stage, payers have not gotten involved with utilization management favoring a biosimilar in the anti-VEGF category. And then within retina practice, there's selective interest. Some are not particularly enthusiastic about a biosimilar because they already have that product available in EYLEA, or in some cases, they've already decided EYLEA HD is gonna be their go-to for all the reasons we mentioned with durability, better profile, you know, next standard of care. There may be situations where if financial motivations tie in, there may be some interest in using biosimilars episodically. That followed in prior biosimilar participation opposite Lucentis a couple of years ago in the marketplace.
Right.
So we'll watch all of this carefully, and we'll stay true to Regeneron, wanna bring the best products in the marketplace, and realizing the opportunity that's most exciting to us is helping patients and prescribers with a better product for their patients going into the future, and that's what we believe we have with EYLEA HD. And fortunately, many physicians, many practices feel the same way.
Got it. Very helpful. And then let's just talk a little bit about the upcoming PDUFAs for some of those expansions. So first of all, how do you feel about this now that you got, like, the PDUFA, new PDUFA, number one? And number two, there are three different things, like Q4 dosing, RVO, and PFS, prefilled syringe approval. So can you just think about... Help us understand the importance of each of them here.
You want to take the second question first, about the importance of each?
The importance of each, I would say, they're all important. So as I'm working closely with our, you know, our regulatory team and Ryan and across the business, all are important because they're different. So as we mentioned on the Q4 weekly dosing, that gives an opportunity for dosing flexibility that you don't need all the time, but you really like to have when you need it, and it gives you confidence for not only your patient care, but also reimbursement. Some practices, frankly, it doesn't stop at all because they see the durability in EYLEA HD, and they have the confidence. Others, they really like to have that safety of being able to have the flexibility. It's important.
Right.
Prefilled syringe, convenience factor, busy practices. Again, I couldn't be more proud of how well EYLEA HD has performed in the marketplace for two years now, not having a prefilled syringe. We know it is the preference. Having it is going to be very attractive to many of our prescribers. And then, of course, the RVO indication, where EYLEA really is the standard of care, and then some, the clinical data with EYLEA HD looks very exciting. We've got a lot of interest in the marketplace for that indication. We don't have the approval yet, but we look forward to that addition to the label.
Yeah, and with regard to the regulatory status of those applications, as we previewed on our second quarter earnings call, we had anticipated a delay in the decision from the FDA due to a manufacturing issue at Novo, Catalent, who is the filler of EYLEA HD vials, as well as the proposed filler for the prefilled syringe. There was an inspection conducted in June, concluded in July, that resulted in observations. Since the inspection concluded, Novo has provided a very comprehensive and robust response to the FDA. And on our PDUFA date for the RVO, and Q4 dosing sBLA, we received a major amendment, which cited this response that Novo made regarding these manufacturers, which pushed out the PDUFA date into the fourth quarter. So this was a good outcome for us.
It suggests that perhaps the FDA believes that these inspection-related issues can be resolved within a three-month window, and hopefully, Catalent is able to resolve it. We certainly are working closely with them, and they are working closely with the FDA. There's been a lot of back and forth between them and we believe they're on the right track. But a lot of this is out of our hands, unfortunately. But we're gonna continue to support Catalent, along with working on backup options, should Catalent not be able to fix their issues in a timely manner.
And all three of these submissions are... There are two submissions, right?
Yes.
I mean, one is so that they all got delayed for the manufacturing reasons at this point.
Yes, exactly. The prefilled syringe submission is under a different pathway than the Q4 and RVO submission. The prefilled syringe is a manufacturing supplement, and a normal course review for a manufacturing supplement is a four-month review. The extension is only two months for that application. So instead of a late August decision, we're now anticipating a late October decision. The sBLA for every four-week dosing and RVO, a twofer, if you will, is an efficacy supplement and that is a three-month extension.
So instead of a late August, it will be a late November d ecision point. And we feel very confident about everything that we have submitted to the FDA with regard to all of those filings. And we believe that once these manufacturing issues at Catalent and Novo are resolved, that the FDA will approve these, and we'll be able to really, hopefully, re-accelerate EYLEA HD uptake in the U.S.
Got it. Very helpful. Do you, do you expect to re-inspection at this point? Because inspection already happened, right? So...
Unclear, and it would be totally up to the FDA- and I don't wanna speculate on that.
Got it. Very helpful. I have to ask, sorry.
Fair enough.
Okay. Awesome. So this is very helpful. Moving on to the other product you have, small product called Dupixent. I mean, amazing that after so many years of launch, you are still growing at 20%+ . I mean, I ask this question every year: Where would the extra... next growth come from? Can you talk a little bit about that?
I appreciate that question every year. Keep asking. No, Dupixent has been remarkable. Eight indications in the U.S., four at blockbuster status. I look forward to growing that number. Most recently, we just launched CSU. Early start with new-to-brand experience has been very favorable. We obviously have a lot of work to do. COPD continues to perform very well in the marketplace, helping, you know, older patients with Dupixent in a way where there's been a you know meaningful unmet need, and we hear remarkable stories of patients that are having much better lung function, not relying on their medications, oxygen therapy, living fuller lives. The stories we get every day on atopic dermatitis patients go on.
Eosinophilic esophagitis has been an amazing indications for patients who were, you know, unable to do something most of us take for granted, enjoying a meal with family or just every day, you know, interactions. Remarkable and certainly in the very competitive asthma biologics category, Dupixent, like so many of the indications, in fact, we lead now... I hate to be boastful, but I have to in this case for you with Dupixent. We lead across seven indications in the U.S., not only in new-to-brand scripts, but also total scripts.
So never wanna get ahead of ourselves, but the growth story on Dupixent has been remarkable, helping, you know, children as young as six months now to older patients as well, you know, across so many disease areas, which is such a differentiated product in terms of its mechanism of action, its tremendous efficacy across type two disease, helping many patients who have concomitant disease as well. Nasal polyps has been a remarkable indication for patients who so suffered with basically feeling like they had a severe sinus infection and not being able to taste or smell every day to normal life. It, you know, it's. For our team, for my commercial team, our medical teams, everyone touching Dupixent, it's really been an amazing product, like EYLEA and EYLEA HD, you know, life-changing for patients to participate. So I think the go-forward picture looks strong.
We obviously have competition coming into many of our indication areas. Across all of our brands at Regeneron, we practice tremendous competitive readiness so that there's great understanding on where our product fits. And I would share so far in the case of, for example, very strong competitors coming into atopic dermatitis, it's helped to grow the market. But because Dupixent is seen as the product with the, you know, go-to first profile, first and best is what I often hear from the KOL community. It probably is helping the growth trajectory of atopic dermatitis. Mo, to your point, we're now eight years in the market with that indication.
Right. Yeah, I know. I know. My boss's, Robin's kid was born on that day, so that's why I remember the day.
Yeah.
So, um-
Yeah, good day.
Yeah. So, awesome. So, great. So let's just talk about COPD a little bit. You have seen a very good traction in the beginning. In what inning are we in, or terminology at this point? So where, I mean, you launched last year, so like, how much more? Like, how, I know the growth has been really rapid there, but, I mean, it's a big market, so how are you thinking about this trajectory.
Of course. COPD is a big market. You know, we launched as the only systemic biologic therapy in COPD. The uptake has been quite strong. We've also. I would say what's very important in the COPD population, it's the one indication where there's not only a commercial population, but there's also the older Part D population. The payer and PBM coverage for COPD is quite strong, and certainly, you know, we're still early, you know, just coming into year plus of launch. So, you know, we continue to see uptake in the indication. But I would share with you, we've seen a steady growth. It's not like we had a lack of growth as we were getting payer coverage. I give a lot of praise to the team and frankly, to the payer community for recognizing the importance of Dupixent in COPD as a game changer.
It's actually really attractive to them because when COPD patients have exacerbations, they go in the hospital. They're not short stays, like so often with asthma patients, it's ER, and you go home. COPD patients go in, and they're usually hospitalized for a long period of time. Not good for them, not good for their payers. So there's been a lot of uptake and recognition of the importance of Dupixent for COPD.
Got it. So you got a very broad label there, right? I mean, the label is not restricting on eosinophilic asthma as such. So do you see usage beyond, like, below three hundred as well here in the real world?
What I would share with you is that the level, the 300 E O level, is important. But when you look at these COPD patients, that they are the appropriate candidates for Dupixent therapy, when their pulmonologists often look into the history of their data, the patients do have history of EOs at this level.
Got it.
So we have not seen... We've seen the importance of education. We've seen the importance of making sure prescribers and offices understand they need to look at the patient history, not what the EO level is on triple therapy or on corticosteroid, which naturally lowers it, but as long as the patient shows in their history, EOs at that level. So we have seen a lot of understanding, common test, y ou know, common language for both the prescribing physician and the payers.
Got it.
But what I would say is most important to them is the remarkable efficacy they see with Dupixent.
Right.
Candidly, it's not unlike when we launched into very different indication, but related specialty. When we launched into asthma, you know, we were the fourth product coming into a crowded market.
Right.
It's the efficacy, it's the safety, it was the results they got at Dupixent that has made it the leading product in the category. Similarly, in COPD, it's not a problem if you have competition as long as your product performs better.
Right. That's for sure. Very helpful. Thank you for that. So, let's just talk about some of the competition out there. So, I mean, we have IL-13 out on the market. I mean, none of them look better than Dupi, and they... At best, they look similar to Dupixent clinical trial performance, but Dupi works really well, in real world as well. So are you seeing them as a challenger, or they, like, you are not seeing them as a threat?
So, I would say, you know, as I was making the comment, we do look at competitors always to make sure that our teams are prepared, our teams are educated, so that if a competitive product comes up, they know how to respond, how to educate. But, you know, as I've mentioned before, and we so often hear, Dupixent is so often viewed first and best, that growing the market because of competition coming in actually is quite favorable for patients. But certainly, the profile of Dupixent is one we all can feel very confident in based on the results it's produced in the market.
Got it. Very helpful. Another interesting readout last week from myasthenia gravis. So congratulations, first of all. So again, now you have a task at your hand, right? Trying to understand, like, help us understand, like, how do you plan to position the product here? And, I mean, it is a crowded market, but then at the same time, it is a growing market as well. How do you think about the market evolution? There's a C5, there is the FCRN, so how do you position your product?
So I think first and foremost, as you mentioned, we were very excited with the clinical data and c ertainly, we are looking forward to planning for and being ready for an approval and then a launch into the marketplace. The data suggests we've got a really nice opportunity in the C5 portion of the marketplace, based on what we're seeing so far, and obviously, more work to be done within the clinical profile of efficacy, safety, and very important in this case, the dosing convenience. So certainly look forward to preparing for a launch in this really important area for gMG patients, where, you know, as we all know, there still remains so much unmet need.
Got it.
Yeah, maybe I'll just highlight some of the clinical data that we reported. In terms of efficacy, the primary endpoint was the myasthenia gravis activities of daily living scale, where the cemdisiran, C5 siRNA monotherapy, resulted in a 2.3-point placebo-adjusted improvement in that scale, which would be the best among all of the C5s at week 26, and is competitive with even the FCRNs at a different time point, but again, it's about the durability of this product and the convenience of the administration being a subcutaneous quarterly injection that ultimately will be self-administered. Probably not at launch, but shortly thereafter, we intend to introduce a prefilled syringe for at-home or HCP administration, so this could be game-changing, and you don't have the cycling on and cycling off of drug.
You have sustained efficacy, and we look forward to presenting that data at an upcoming medical meeting where everyone can see the profound impact it has, not only over the duration of twenty-six weeks, but how quickly the onset is. We're very excited about that as well.
Got it. So this is the sales force you do not have at this point, right? So this is something you'll have to build up.
We will have to put together the commercialization footprint. We look forward to that.
Right.
I would share with you, you know, over the last, you know, many years now, as our portfolio and our in-line brands have grown, you know, obviously, EYLEA was long ago established for ophthalmology and then similar footprint, combined footprint and expertise for EYLEA HD. But think across Dupixent, we've built out, you know, dermatology, gastroenterology, pulmonology. I won't name them all, and certainly, you've also seen us build with success in oncology organization, now oncology and hematology.
So we've deliberately, in the commercial organization, had talent at Regeneron or brought talent into the organization that has had experience across multiple therapeutic areas and also internationally, so that we're at the ready and thrilled as we have the opportunities to bring in products from more therapeutic areas. We'll always build out the commercialization, not only the headquarters strategy execution team, but the customer-facing model that matches the needs of that product.... In some places, we're able to take a portfolio approach, like our market access payer teams, but then we'll also build specific to that specialty, so we make sure we make the most meaningful impact.
I'll share as an example, when we build out our oncology team, we had some Regeneron colleagues who had depth of oncology experience, so they were potentially very strong candidates for roles if they were interested. But then also we brought in industry best, and fortunately, and I'm thrilled about this, we've had a lot of people who've wanted to join Regeneron because of the reputation, because of the science, because of the culture of the company. So I, I would expect that that will continue as we go into neurology and other therapeutic areas in the future.
Yeah, maybe last point on this, you know, this is just the first of three potential indications with the C5 franchise. So we saw success in myasthenia gravis with not only the monotherapy but also the combination of cemdisiran with pozelimab, which hit all of the primary and key secondary endpoints as well. The efficacy results weren't as impressive as cemdisiran monotherapy, but, notwithstanding that, still showed great efficacy. We have an ongoing Phase III study in PNH as well as in geographic atrophy, and in geographic atrophy, we're looking at both the combination as well as the siRNA monotherapy. So there's a lot more opportunity here, and when we looked at street numbers for C5, in 2030, they were like $225 million.
Today, myasthenia gravis is something like a $5 billion market and expected to double between now and 2030. It's an exceedingly low bar for Regeneron, I think, even in just myasthenia gravis, to exceed that. We're very excited about moving this forward and hopefully filing with the FDA by the first quarter of 2026.
Got it. Very great. I mean, awesome. Let's talk about two last topics before we conclude. LAG-3, you have interesting data coming up later this year. I mean, they... But you have great LAG-3 and good, great PD-1 here, but you are comparing it against a PD-1, which is also a good PD-1. Can you talk a little bit about how you are thinking about what is meaningful here, and yeah, like, I mean, just- At this stage here.
Yeah. So, we have fianlimab, which is our LAG-3 antibody, combined with Libtayo in an ongoing Phase III study in first-line advanced melanoma with pembrolizumab or Keytruda as the comparable arm. Keytruda, historically, at least in its label, has performed somewhere around three to four months of median PFS. We've seen some studies have a little more, some studies have a little less. We don't really know what to expect from pembrolizumab beyond what the historical analogs are, and that would probably put us somewhere in the mid to high single digit months. Fianlimab plus Libtayo in three independent cohorts in Phase I, when pooled, had a median PFS of 24 months, and a response rate in the upper 50s when pooled, as opposed to response rates, you know, in the low 30s for pembrolizumab.
So all of that is very encouraging, but of course, we need to get the results here. And I think for differentiation, you don't need to get into the twenties here. The bar kind of, I think, for us, is somewhere in the low to mid-teens perhaps, and anything above that would be exceedingly differentiated from the other approved advanced melanoma therapies in the market. We announced on our second quarter earnings call that we expect this data in late 2025 or potentially early 2026 due to a slowing of events. This is an event-driven study, and we need a certain number of events in order to conduct the final analysis on progression-free survival.
Can interpret a slowdown in event rate accrual, you know, in a couple of ways, whether it's outperformance by the comparable arm or whether patients that are responding to the active arm are having very long and durable responses, which is certainly what we hope for. We'll get our answer in a few months. I don't know how else to. I'll let you guys speculate on what that's gonna look like, but we're very excited about fianlimab and LAG-3 in melanoma.
Uncertainty is the self-identity.
Yes.
So, awesome. So, like, this is very helpful. And then, let's just touch upon itepekimab here as well. What are the next steps here? I'm sure you've seen a lot more data now after the top line. And then there's a partner as well, so you have to think about that as well. So how do you think about it?
Yeah, us and Sanofi have had a very hard look at the data. And just to refresh everyone's memory, we had a highly successful AERIFY-1 study where there was a roughly 27% reduction in annualized exacerbation rate in former smokers. But in AERIFY-2, we had a very underwhelming result and one that did not meet statistical significance, mainly because we saw an attenuation of effect in the second half of the AERIFY-2 study. So we've been scratching our heads and looking very hard at what could have driven that. We have a few ideas, but I would say we're not ready to share them at this point.
The next steps are for us to sit down with regulators, the FDA, the European regulators, other global regulatory authorities, explain the data set, and understand what potential next steps would need to be taken to have a filing that could be approvable. In the background, I'd say we are contemplating another Phase III study in terms of what that could look like, how to size it, how to power it, based on our learnings from AERIFY-1 and AERIFY-2. No final decision on whether or not we're going to conduct that third Phase III has been made, and it will be a joint decision between Regeneron and Sanofi, but probably not until we have those discussions with regulators.
I would expect this decision to be made certainly before the end of this year, but I don't have a more precise timeline for you today, Mohit.
Got it. Very helpful. A nd one question on, like, I mean, you have a very strong balance sheet. And, I mean, like, Regeneron is a very innovative company. Any other company, people would be just clamoring for BD, but, I mean, I'm sure you are getting those questions as well at this point. So, has anything changed internally in terms of thought process around BD and use of cash in recent months, especially after Dupixent?
No, I mean, I think one benefit we have at Regeneron is Len and George have they founded the company and have a long-term vision for where we're going, and there's not gonna be a knee-jerk reaction because the second half of one study failed. So we continue to have that long-term view, but we also don't have blinders on about the innovation that's going on in the rest of biotech and pharma. So I think we are, you know. We've always cast a pretty wide net. Historically, we have focused on earlier stage opportunities and platforms that could complement our strengths and antibodies.
I think we've seen a lot of good results from that, quite frankly, between this latest result with the C5 siRNA that we in-licensed from Alnylam to the ongoing gene editing TTR gene editing opportunity at Intellia in TTR cardiomyopathy. So we have a lot of, I think, successes to talk about with those earlier opportunities. But we also understand that there is sometimes more of a focus on the later stage ones, and we don't discount them because they're, you know, past proof of concept. We just don't wanna overpay for something that may not be truly differentiated. So we continue to look. We're very active. Don't always see that activity 'cause not all deals come to fruition, but trust me, there's a lot going on in the BD department at Regeneron.
Awesome. One last question I ask every year. One year down the line, I hope you are here. I hope I'm here. What would make you look back at the year and say, "It was a great year for us?
Yeah. So I'll start, and of course, with Regeneron, I have so many choices, which is amazing b ut I'll stay a little bit near-term focused. So I do think that the catalysts for our EYLEA HD are very important. They're very near term, and we just recently have launched new indications in Dupixent, and we have many. We will continue to make those perform well. We haven't talked about Libtayo today yet but I do wanna share that we thought the data for cutaneous squamous cell, adjuvant therapy was very exciting and, you know, potentially an indication launch coming there, next year.
Beyond that, I would say dinaciclib just launched in the marketplace for, you know, hematology patients. Unique profile, efficacy, safety. We talked a little before, and we're off to a, an early start, just having launched within the last, you know, couple of months, but early days, strong indicators, and certainly that is such a meaningful and large potential marketplace for the future.
Awesome.
And then, the next year for us, I think it's really about getting some of these regulatory issues fixed, and hopefully, that can even happen in the next few months. But in addition to that, advancing the pipeline more broadly, whether it's, you know, fully launching the factor XI program in anti-thrombosis. The obesity program, we hope to launch with the in-licensed asset from Hansoh. We look to read out the fianlimab Libtayo melanoma data, as well as some, maybe under the radar opportunities in allergy with birch and cat readouts coming in the near term.
As well as in the genetics medicine division, where we have, you know, Otoferlin, which is our hearing deafness, a rare disease for a genetic hearing loss, as well as some interesting opportunities in NASH and MASH. So all of those, we hope to have some more data on in the near term, along with, you know, the hemonc opportunities, where we're enrolling earlier stage studies in really large categories. So overall there's a lot going on at Regeneron.
Yeah. I would add to Ryan's comment, and then kind of going back a little bit to one of your comments, from a commercialization standpoint, in all these areas, we already have existing experience or new indications. We would be thrilled for cardiometabolic, obesity, certainly commercialization opportunity there. So whether a current therapeutic area or a future, we are very much prepared to bring that into the marketplace and, you know, successfully position ourselves for patients and our prescribers.
Awesome. On that high note, thank you very much. Really appreciate it.
Thanks, everyone.
Thank you, everyone. Good to see you.
Good to see you too.