Regeneron at Wells Fargo Conference: Strategic Insights on Growth

On Thursday, 04 September 2025, Regeneron Pharmaceuticals Inc (NASDAQ:REGN) presented at the Wells Fargo 20th Annual Healthcare Conference 2025, offering a strategic overview of its current performance and future outlook. The discussion highlighted strong growth in key products like EYLEA HD and DUPIXENT, while addressing challenges such as affordability and regulatory hurdles. The company emphasized its commitment to innovation and expanding its product portfolio amidst competitive pressures.

Key Takeaways

• EYLEA HD experienced a demand growth of 16%, with anticipated label enhancements expected to boost uptake.
• DUPIXENT continues to grow over 20%, leading in 7 US indications.
• Regeneron is advancing its pipeline with promising developments in C5 siRNA monotherapy for Myasthenia Gravis.
• The company is actively pursuing business development opportunities to strengthen its platform.
• Challenges include affordability issues for EYLEA and competition from biosimilars.

Financial Results

• EYLEA HD:

- Achieved a 16% demand growth last quarter, up from 5% in the previous quarter.

- EYLEA and EYLEA HD together make up 60% of the anti-VEGF branded market.

- RVO indication was valued at $1 billion in 2024.

• DUPIXENT:

- Continues to grow at over 20%, maintaining leadership in 7 US indications.

• C5:

- Sales reached $225 million in February 1930.

- The Myasthenia Gravis market, valued at $5 billion, is expected to double by February 1930.

Operational Updates

• EYLEA HD:

- Label enhancements including Q4 weekly dosing and a prefilled syringe are anticipated.

- PDUFA date for RVO and Q4 dosing SBLA delayed to Q4 due to manufacturing issues.

- Prefilled syringe submission expected in late October, with SBLA for dosing and RVO in late November.

• DUPIXENT:

- Recently launched in Chronic Spontaneous Urticaria (CSU).

• Myasthenia Gravis:

- Approval and market launch planning underway.

Future Outlook

• EYLEA HD:

- FDA approval for label enhancements is expected to drive further uptake.

• DUPIXENT:

- Plans to expand growth across existing indications, including COPD.

• C5 siRNA Monotherapy:

- Filing with the FDA for Myasthenia Gravis anticipated by 2026, with expansion plans for PNH and geographic atrophy.

• Fianlimab + Libtayo:

- Phase III melanoma data expected in late 2025 or early 2026.

• Itapacumab:

- Discussions with regulators on ERAFI I and II data to determine next steps, including a potential Phase III study.

Q&A Highlights

• EYLEA HD Affordability:

- Lower charitable contributions have impacted patient access due to out-of-pocket costs. Regeneron offers a matching program to assist.

• Biosimilar Competition:

- Payers have not favored biosimilars; retina practices prefer EYLEA or EYLEA HD.

• DUPIXENT Growth:

- Continues due to efficacy across multiple type 2 diseases.

• COPD Market:

- Strong payer and PBM coverage; used even with lower eosinophil levels if historically higher.

• BD Strategy:

- Focused on early-stage platforms that complement antibody strengths.

For more detailed insights, readers are encouraged to refer to the full transcript provided below.

Full transcript - Wells Fargo 20th Annual Healthcare Conference 2025:

Mohit Bansal, Biotech Analyst, Wells Fargo: 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 Regeneron management team. So we have Ben McCourt, the Head of Commercial at Roche, Regeneron and we have Ryan Kroth, he heads the IR operations here. And team Regeneron has been constant with us for the last four years.

So thank you very much for being ahead with us.

Ryan Kroth, Head of IR, Regeneron: 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. I’d like to remind you that our remarks made today may include forward looking statements about Regeneron.

Each forward 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.

Mohit Bansal, Biotech Analyst, Wells Fargo: Great. Awesome. So with a lot to talk about. There’s a lot of commercial execution going on, a lot coming up there. So great quarter with HydroXyla. So can you talk a little bit about the journey of high dose

EYLEA in the beginning? And then obviously, a lot changed with the charity thing under 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 ILIA.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: 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, 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, 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 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.

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 five percent, others ten percent, maybe fifteen percent, twenty percent. The fact is though the physicians don’t know when they’re administering product which patients are going to be the ones that need the shorting 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, fifty, eighty, hundreds 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. I’ll reference in 2024 that was a $1,000,000,000 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.

Ryan Kroth, Head of IR, Regeneron: And 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. 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. And historically, some patients have relied on charitable contributions to offset their out of pocket costs. These out of pocket 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 donor who would like to help these patients out.

Then 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, it requires more frequent injections, and so these patients need the better drugs and need help with their financial supporting them financially, which we intend to do, but with the help across the entire spectrum of potential donors.

Mohit Bansal, Biotech Analyst, Wells Fargo: So is it fair to say the 2Q strength you have seen in high dose EYLEA has not like, charity or the new contribution to foundation has not contributed to that yet. It is mostly the strength of the product at this point.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: So maybe let me take a start on that. What I would share is that the market is it’s complicated. It’s a large market. So EYLEA HD is a product that’s been in market now for about two years

Mohit Bansal, Biotech Analyst, Wells Fargo: Right.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: Is probably less impacted by the affordability challenge as EYLEA, which is a bigger product.

Mohit Bansal, Biotech Analyst, Wells Fargo: Right.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: 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 firstamab, as is Avastin.

Ryan Kroth, Head of IR, Regeneron: Right.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: So it it you really can’t just dissect one away from affordability, but I also would say that a larger product is going to be appreciating a greater impact from the affordability situation right now.

Mohit Bansal, Biotech Analyst, Wells Fargo: Got it.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: I hope that’s helpful. No.

Mohit Bansal, Biotech Analyst, Wells Fargo: That that’s very helpful. Thank you.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: I also will share, though, that the overall franchise performance of being 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.

Mohit Bansal, Biotech Analyst, Wells Fargo: 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 any base. 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 how are you competing against Eylea biosimilar, which is a very good product, actually?

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: So I would say the market again Yeah. To the 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 going to 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 financially motivations tie in, there may be some interest in using biosimilars episodically.

That followed in prior biosimilar participation opposite Lutcentis a couple of years ago in the marketplace.

Mohit Bansal, Biotech Analyst, Wells Fargo: Right.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: So we’ll watch all of this carefully and we’ll stay true to Regeneron, want to 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, physicians, many practices feel the same way.

Mohit Bansal, Biotech Analyst, Wells Fargo: 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? Do you want

Ryan Kroth, Head of IR, Regeneron: to take the second question first?

Mohit Bansal, Biotech Analyst, Wells Fargo: What’s the

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: important Well, the important speech, would say, they’re all important. So as I’m working closely with 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. 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.

Ryan Kroth, Head of IR, Regeneron: 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 was and 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 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.

Mohit Bansal, Biotech Analyst, Wells Fargo: And all three of these submissions are like there are two submissions, right, or in Yes. So they all got delayed for the manufacturing reasons at this point.

Ryan Kroth, Head of IR, Regeneron: Yes. Exactly. The prefilled syringe submission is under a different pathway than the q four 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. Right. The SBLA for every four week dosing and RVO, a twofer, if you will, is an efficacy supplement, and that is a a three month extension. So instead of a late August, it will be a late November Right. Decision 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 Novo are resolved, that the FDA will approve these, and we’ll be able to really, hopefully, reaccelerate EYLEA HD uptake in The U. S.

Mohit Bansal, Biotech Analyst, Wells Fargo: Got it. Very helpful. Do expect to do inspection at this point? Because inspection already happened, right?

Ryan Kroth, Head of IR, Regeneron: Unclear, and it would be totally up to the FDA, I don’t want to speculate on that. It.

Mohit Bansal, Biotech Analyst, Wells Fargo: Very helpful. I have to ask. Sorry. Fair enough. So okay.

So awesome. So this is very helpful. Moving on to the other product you have, small product called Dupixent. So I mean, amazing that after so many years of launch, you are still growing at 20% plus. So I mean, I ask this question every year.

Where would the extra next growth come from? So can you talk a little bit about that?

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: Well, I appreciate that question every year. So keep asking. But nerdapixon has been remarkable. Eight indications in The US, 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 older patients with DUPIXENT in a way where there’s been a 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. Esophagitis has been an amazing indication for patients who are unable to do something most of us take for granted, enjoying a meal with family or just everyday, you know, 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 US not only in new to brand scripts but also total scripts. So never want to 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.

Know, for our team, for my commercial team, our medical teams, everyone touching Dupixent has 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.

Mohit, to your point, we’re now eight years in the market with that indication. Yeah.

Mohit Bansal, Biotech Analyst, Wells Fargo: I know. I know. My boss is Robin’s kid was born on that day. So because I remember the day. Yeah.

So 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 you we are in, sport terminology at this point. So where I mean, you launched last year. So like how much more like, I know the growth has been really rapid there.

But I mean, it’s a big market. So how are you thinking about this

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: Of course. So PUD 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 and 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.

Mohit Bansal, Biotech Analyst, Wells Fargo: Got it. So you’ve got a very broad label there, right? I mean, label is not restricting on eosinophil as such. So do you see usage beyond the beyond, like, below 300 as well here in the real world?

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: So what I would share with you is that the level the 300 EO level is important. But when you look at these COPD patients that there 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.

Ryan Kroth, Head of IR, Regeneron: Got it.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: 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 corticosteroids, which naturally lowers it. But as long as the patient shows in their history, EO is at that level. So we have seen a lot of understanding, common test, you know, common language for both the prescribing physician and the payers.

Mohit Bansal, Biotech Analyst, Wells Fargo: Got it.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: What I would say is most important to them is the remarkable efficacy they see with DUPIXENT. And candidly, it’s not unlike when we launched into very different indication but related specialty. When we launched into asthma, we were the fourth product coming into a crowded market.

Mohit Bansal, Biotech Analyst, Wells Fargo: Right.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: It’s the efficacy. It’s the safety. It was the results they got at DUPIXENT that is made 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.

Mohit Bansal, Biotech Analyst, Wells Fargo: 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, have the IL-thirteen out on the market. I mean, none of them look better than Dupi. And they, at best, they look similar to Dupi’s clinical trial performance. But Dupi works really well in real world as well. So are you seeing them as a challenger?

Or are they, like, you are not seeing a

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: So I would say, 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 as I 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.

Mohit Bansal, Biotech Analyst, Wells Fargo: Got it. Very helpful. Another interesting readout last week from my senior gravis. So congratulations, first of all. So again, now you have a task at your hands, right?

So just 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. So how do you think about the market evolution? There’s a C5. There’s a FcRn.

So how do you position yourself?

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: So I think first and foremost, as you mentioned, we were very excited with the clinical data. And certainly, 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, as we all know, there still remains so much unmet need.

Ryan Kroth, Head of IR, Regeneron: Got it. And 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 semdisiran C5 siRNA monotherapy resulted in a two point three point placebo adjusted improvement in that scale, which would be the best among all of the C5s at week twenty six, and is competitive with even the FcRn 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, 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.

So we’re very excited about that as well.

Mohit Bansal, Biotech Analyst, Wells Fargo: 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?

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: We will have to put together the commercialization footprint. We look forward to that. And I would share with you, over the last many years now, as our portfolio and our in line brands have grown, obviously Eyleo 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 dermatology, gastroenterology, pulmonology. I won’t name them all.

And certainly, you’ve also seen us build with success in oncology organization, So now oncology and 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 headquarter 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 would expect that that will continue as we go into neurology and other therapeutic areas in the future.

Ryan Kroth, Head of IR, Regeneron: Yes. Maybe last point on this. 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 semdisiran with pozilimab, which hit all of the primary and key secondary endpoints as well. The efficacy results weren’t as impressive as semdisram monotherapy, but notwithstanding that, still showed 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 02/1930, they were like two hundred and twenty five million. And today, myasthenia gravis is something like a $5,000,000,000 market and expected to double between now and 02/1930.

So it’s an exceedingly low bar for Regeneron, I think, even in just myasthenia gravis, to exceed that. And we’re very excited about moving this forward and hopefully filing with the FDA by the 2026. Got it.

Mohit Bansal, Biotech Analyst, Wells Fargo: Right. Great. I mean, Awesome. So let let’s talk about two last topics before we conclude. So LAG-three, you have interesting data coming up later this year.

So, I mean, the but you have a great LAG-three and a great, great PD-one here, but you are comparing it against a PD-one, which is also a good PD-one. So can you talk a little bit about how you are thinking about what is meaningful here? Yeah, like, I mean, just Sure. At stage

Ryan Kroth, Head of IR, Regeneron: Yeah. So we have fianlimab, which is our LAG-three 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 four to five 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.

Fiamlimab plus Libtayo in three independent cohorts in phase one, when pooled, had a median PFS of twenty four months, and response rate in the upper 50s when pooled, as opposed to response rates in the low 30s for pembrolizumab. 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 20s here. The bar kind of, I think, for us is somewhere in the low to mid teens perhaps, and anything above that would 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 ’twenty five or potentially early twenty twenty six 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. You can interpret a slowdown in event rate accrual in a couple 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 we’re very excited about fiamimab and MAG-three in melanoma.

Mohit Bansal, Biotech Analyst, Wells Fargo: Uncertainty is the cell side dream. Yes. Awesome. So, like, this is very helpful. And then let’s just touch upon itapacumab here as well.

What are the next steps here? I’m sure you have done you’ve seen a lot more data now off the off 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 that?

Ryan Kroth, Head of IR, Regeneron: Yeah, us and Sanofi have had a very hard look at the data. Just to refresh everyone’s memory, we had a highly successful ERAFI I study, where there was a roughly 27% reduction in annualized exacerbation rate in former smokers. But in ERAFI II, 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 ARIFI-two 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 three study in terms of what that could look like, how to size it, how to power it, based on our learnings from ERAFI I and ERAFI II. But 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 time line for you today, Mohit.

Mohit Bansal, Biotech Analyst, Wells Fargo: Got it. Very helpful. One question on like, I mean, you have a very strong balance sheet. And I mean, Regeneron is a 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 has anything changed internally in terms of thought process around BD and use of cash in recent months, especially after a 02/2009?

Ryan Kroth, Head of IR, Regeneron: No. I mean, 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 going 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 we’ve always cast a pretty wide net.

Historically, we have focused on earlier stage opportunities and platforms that could complement our strengths in 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 later stage ones, and we don’t discount them because they’re 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, because not all deals come to fruition. But trust me, there’s a lot going on in the BD department at Regeneron.

Mohit Bansal, Biotech Analyst, Wells Fargo: Awesome. One last question I ask every year. One year down the line, I hope you are here, I hope I am here, What would make you look back at the year and say it was a great year for us?

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: Yeah. So I’ll start. And of course, with Regeneron, I have so many choices, which is amazing. Yeah. But I’ll stay a little bit near term focused.

Mohit Bansal, Biotech Analyst, Wells Fargo: Right.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: So I do think that the catalysts for 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 want to 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, would say linazific just launched in the marketplace for, you know, hematology patients, unique profile, efficacy, safety.

We talked a little before. You know, we’re off to 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.

Mohit Bansal, Biotech Analyst, Wells Fargo: Awesome.

Ryan Kroth, Head of IR, Regeneron: And in 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 fully launching the Factor XI program in anti in thrombosis, the obesity program we hope to launch with the in licensed asset from Hansel. 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 otoferlin, which is our hearing deaf, a rare disease for a genetic hearing loss, as well as some interesting opportunities in NASH and NASH. So all of those, we hope to have some more data on in the near term, along with the hem onc opportunities where we’re enrolling earlier stage studies in really large categories.

So overall, there’s a lot going on in Regeneron.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: I would add to Ryan’s comment and then kind of going back, Mohit, 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 successfully position ourselves for patients and our prescribers.

Mohit Bansal, Biotech Analyst, Wells Fargo: Awesome. On that high note, thank you very much. We appreciate it.

Ben McCourt, Head of Commercial at Roche, Regeneron, Regeneron: Thanks Thank you, everyone. Good to see you. Good to see you.

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