Spain’s credit rating upgraded to ’A+’ by S&P on strong growth
On Monday, 08 September 2025, Regeneron Pharmaceuticals (NASDAQ:REGN) presented at the Morgan Stanley 23rd Annual Global Healthcare Conference. The company discussed its robust pipeline, aiming to deliver over 10 blockbuster drugs, while also addressing challenges such as market undervaluation and manufacturing delays.
Key Takeaways
- Regeneron anticipates more than 10 blockbuster drugs emerging from its pipeline in the coming years.
- The company holds a strong cash position between $15 billion and $20 billion, supporting R&D investment and shareholder returns.
- DUPIXENT remains a leader in prescriptions across multiple indications, despite competitive pressures.
- Manufacturing challenges are being addressed with plans to insource filling processes.
- Regeneron is focused on strategic business development and capital allocation, including share buybacks.
Financial Results
- R&D spending is prioritized, with strategic partnerships supplementing internal efforts.
- In Q2, Regeneron repurchased $1.1 billion of its shares, totaling $2.2 billion in the first half of 2025, reducing shares outstanding by 3.2 million.
- The company has $2.8 billion authorized for future buybacks as of June 30th.
Operational Updates
- DUPIXENT leads in prescriptions for seven out of eight indications in the U.S., with significant unmet need in atopic dermatitis.
- Recent launches include CSU and CAPD, with strong performance across skin indications, asthma, and nasal polyps.
- In oncology, Ordspono has been launched in Europe, and Linozyvic is expected to launch soon, with progress in both academic and community settings.
- Manufacturing issues related to filling are being resolved with plans to establish four internal filling lines by next year.
Future Outlook
- Regeneron aims to develop more than 10 blockbuster drugs, focusing on cancer, hematologic tumors, complement-mediated programs, Factor 11, allergy, and MASH.
- The company is exploring combination therapies and novel approaches, such as Rituxan-free regimens in DLBCL.
- Strategic differentiation through head-to-head trials and targeting large market opportunities in diseases like myasthenia gravis and geographic atrophy.
Q&A Highlights
- Regeneron addressed competition for DUPIXENT, noting that competitor OX40 data has been disappointing.
- The company emphasized its focus on internal R&D investment and strategic business development.
- Discussions included the impact of regulatory efforts to lower drug prices and support for Medicare co-pay assistance.
For further details, please refer to the full transcript below.
Full transcript - Morgan Stanley 23rd Annual Global Healthcare Conference:
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Great, good morning everybody. I’m Terence Flynn, Morgan Stanley’s U.S. Biopharma Analyst, and I’m very pleased to be hosting Regeneron to kick off our 23rd annual Global Healthcare Conference this morning. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. Today from the company, we have Dr. Leonard Schleifer, who’s the Board Co-Chair, President and CEO; Marion McCourt, Head of Commercial; and Christopher Fenimore, the company’s CFO. With that, I’m going to turn it over to Chris, and then we’ll go over to Len for opening remarks.
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Thanks, Terence. Real quick, I would like to remind you that remarks made today may include forward-looking statements about Regeneron Pharmaceuticals, and 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 Pharmaceuticals’ SEC filings. Regeneron Pharmaceuticals does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Thanks, Chris. Thanks, Terence, for having us here. It’s good to be at the 23rd Morgan Stanley Conference. Chris started out with his statement about forward-looking statements. Usually, we kind of look backward, but I’ve decided today we’re going to really look forward and talk to you about what the future looks like. Everybody is familiar, I think everybody’s familiar with Regeneron’s story about EYLEA and DUPIXENT. I want to tell you that we think we can see the future where we can have significantly more than 10 blockbusters emerge in our trials over the coming years. I’d like to sort of highlight what some of those might be. If you start with our cancer program, LIBTAYO is already on its way to being a blockbuster. That’s our PD-1 blocker.
We have some very interesting data that Keytruda was not able to get in the adjuvant setting of the CSCC, that’s viewed by the FDA, which we think has a very large market potential, especially because Keytruda failed in that setting. We also have, beyond LIBTAYO or its monotherapy, a combination therapy with LAG3 in the melanoma setting. We’re looking forward to getting data from that. We turn to really our hematologic tumors. We have three really exciting drugs there, which we all think are going to be pretty special and all have blockbuster potential. Let me start with our Linozyvic, which has been approved for the treatment of advanced multiple myeloma. We think our data there is very compelling. We think its core study comparisons notwithstanding. We have really the best in class in terms of both efficacy and perhaps even safety and convenience in end-stage myeloma.
End-stage myeloma is a relatively small indication. We’re going to go for the whole enchilada, so to speak, in myeloma, where we’re going all the way to the very beginning, pre-malignant MGUS or light chain amyloidosis, sort of these pre-malignant conditions, all the way through first line, second line, and so forth. We are not range-bound to include Darzalex, as some of our competitors are. We think, in fact, monotherapy may be the way to go. We’ve got some pretty exciting early-stage data there that suggests that you can get dramatic, if not profound, responses with monotherapy with our Linozyvic, which is a BCMAxCD3 bispecific. We also have similar compelling efficacy with our two drugs for lymphoma, our two treatments for lymphoma. Ordspono, our CD20 bispecific, is pending approval.
We’re very excited about its potential, especially because we’ve got some very early-stage data now in frontline follicular, where we’ve been able to see in the first dozen or so patients we’ve treated 100% complete responses. We get that going. That’s a very significant and big opportunity. Same thing in DLBCL. We are not bound, as our competitors seem to be, to include Rituxan. In fact, we’re looking at Rituxan-free. The standard of care up front for DLBCL is typically Rituxan plus a chemotherapy regimen called CHOP. Our CHOP maybe gives about a 75% complete response rate. We’re looking at already in our first preliminary dozen or so patients 100%. We’re very excited about the prospects for our cancer program. Once again, we’ve got Libtayo, we’ve got Libtayo plus our LAG3, we’ve got Linozyvic, and we’ve got Ordspono. Really big opportunities there, which we’re working very hard on.
Beyond that, let’s take a look at some recent data we had in our complement-mediated program. As you know, we have both an siRNA, which will decrease complement, and we can combine that with a C5 antibody. The combination takes complement basically completely, inhibits it. If you look in patients with PNH, we can show clearly head-to-head that we’re able to treat patients better, looking at LDH, which is a measure of the complement-mediated destruction of red cells. We can completely normalize where the Soliris, seculizumab, can’t do that. In fact, the combination there is the best that’s been seen. We’re pursuing that in phase 3. In addition, we have our myasthenia gravis data of phase 3 that we released. In this case, it seems that monotherapy with the siRNA is all you really need, which could be very important because you don’t have to completely inhibit complement.
Therefore, you might get a safety benefit. The safety profile looked very good. The phase 3 data core study comparisons were best in class for the C5 class. I think, frankly, it can compete well. I know we’re competing in another room. Our genetics is talking. They’ve got a very interesting CRN story. If you look at their label, you don’t get complete clinical benefits. You sort of get a U-shaped, which you have to sort of cycle through. We get complete benefit. We’re very excited that we can compete against them. We can compete certainly against the C5 antibodies. We can compete in myasthenia. We can compete in PNH. Of course, the wild card is we think we might be able to have something special in geographic atrophy, which is another big opportunity for us. That’s plus the cancer, plus the C5.
We also have opportunity in our factor 11 program, which we’ve already shown in total knee replacement works very nicely and safely. We’re in phase 3 there. We’ll be looking at all sorts of different settings where you can perhaps do better than the DOACs on safety with less bleeding and equal or better efficacy. Phase 3 program is going to be very large for the factor 11 opportunity. We also, of course, have announced this morning our allergy program. We’re very committed to allergy. We’ve got a multi-prong strategy. Some stuff we haven’t even talked about, we think can totally eliminate allergy. This was an example today where we could treat specific allergies, both cat allergy, which is very common, birch allergy, which is very common. We can block more than 50% if you put the cat dander directly in somebody’s eye.
This is after a subcutaneous administration of these blocking antibodies. That’s really interesting. That might be a very important lifestyle drug. There are millions and millions of people who have both cat allergy and birch allergy. I won’t go through the rest of the program, but we also have very quickly in our metabolic area some exciting stuff you’re going to hear about in the very near future about MASH. We have, of course, our Praluent for cholesterol lowering, where we won that lawsuit against Amgen for antitrust. We’re waiting for the court to do some structural remedies, and we might be able to revive that into a fairly competitive program there as well. Lots, lots, and lots of stuff in the pipeline while Marion keeps the fires burning bright on DUPIXENT and EYLEA. Great. Thanks so much for framing all of that, Len.
I know we’re going to unpack a lot of this, but I guess just big picture, if I think back to DUPIXENT, you know we used to talk a long time ago about the size of this opportunity. You guys were always more optimistic than Wall Street. I think I remember I maybe had $2 billion in my model at some point, and you proved me wrong, proved my optimism wrong.
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Did we do that yesterday? No.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: As I look at kind of, you know, where the stock is now, look at these opportunities. As you go down this list, do you think the street is missing the commercial opportunity here? Is it POS? What is the street missing that you’re enthusiastic about? You kind of go down this list, but I’d argue a lot of this is not reflected in the current valuation. What do you think the street is missing as you go down this list in terms of commercial opportunity?
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: I think they’re missing the whole pipeline. I think there’s too bright of a light on what’s going on with DUPIXENT and EYLEA. To ask somebody, we have 45 things in the clinic. Probably we put another dozen or so every year into development. Under Dr. George Yancopoulos, who’s the Chief Scientific Officer of Regeneron Pharmaceuticals and the Board Co-Chair and the co-inventor of most of these programs, it’s the most prolific pipeline in the history of the industry, I would dare to say. I think it’s very hard. If you were to devote your time to look at 45 programs, you’d have nothing else, no time to do anything else. People have some inability, I think, to focus on the pipeline.
If you look at our cash position, which is somewhere between $15 billion and $20 billion, and you look at the cash flow just from DUPIXENT, I think it’s pretty clear evidence that the pipeline is being ignored. I think the pipeline is starting to deliver. We have more stuff coming out in the not-too-distant future. That’s what I think is going on.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Great. Maybe just a good segue into capital allocation. It seems like based on the pipeline you have, that there’d be limited interest for later-stage deals. As you think about the lens through which you apply business development, maybe you and Chris can kind of tag team this. How do you think about capital deployment here in the context of your pipeline, the investments that are required here, and also external opportunities?
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: I’ll let Chris dive into the details. Let me just say, we’ve done an analysis. People say you spend a lot of money on R&D. If you actually look at what we spend on R&D versus what a lot of other companies spend on R&D, when you add in when they buy R&D, that’s just spending on R&D, but it’s hidden someplace else on your financial statements. I don’t think we’re actually out of line at all. We can show you evidence that, yeah, we spend a lot, but we don’t spend nearly as much, or we don’t waste nearly as much. There have been some analyses that people have spent $100 billion to create $60 billion in value or something like that. This external purchasing is not something we’re against.
When it becomes just a crazy auction and people are buying things that are worth $5 and paying $10 for it, we don’t have any interest or need for something like that. I don’t think people are being fooled, frankly, by people who do that. You can look at some of these massive purchases, and we can go through them in a more less bright light environment so people don’t get mad at me. Some of these deals are pretty darn stupid. Chris can comment on our big picture deals.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: I think Len hit all the highlights. Obviously, first and foremost, our top priority is investing in our own internal R&D capabilities, supplementing that with some business development activity, and not just limited to M&A, Terence. Obviously, we do a lot on the partnership side as well. If you look at the last component of our capital allocation strategy, it’s returning capital to shareholders. We initiated a dividend earlier this year. The primary way of returning capital to shareholders is doing buybacks. We in Q2 bought back $1.1 billion of our shares. For the first half of the year, $2.2 billion, reduced shares outstanding by 3.2 million shares, and as of June 30, have $2.8 billion still authorized. We’re obviously, as Len said, with the amount of cash that we have, well-capitalized to execute on all of our plans.
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: To be clear, Terence, we do deals. We just do they’re less expensive because we tend to find things early that fit in nicely adjacent to what we do. We’re not averse to buying something, but we don’t want to spend shareholders’ money to decrease value.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Yep, understood. I know it’s something you don’t want to probably talk about too much, but again, it’s top of mind for everyone right now, just given where we are in the policy environment. Maybe you could just give us your perspective on kind of the tariff MFN situation, where we are, and are we getting closer to a resolution in your view? I know the other thing that you guys have talked a lot about is Medicare co-pay assistance as an opportunity to maybe lean into. Maybe give us a view on kind of both of those and where we stand right now.
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Right. I read my dear Len letter very carefully. I’ll say this. The administration has their focus on trying to lower drug prices. We have said that the problem is that somebody has to pay for innovation, and the Europeans aren’t paying for innovation. I have said that long before this administration. I’ve been saying this for a decade, that we have to do something about getting the Europeans to pay for innovation. That isn’t something one company can do. We go out there and say, we’re not going to sell it for less than we sell it in the U.S., then there are six other companies that will step in in front of you. It’s a very difficult situation. Plus, the public really doesn’t understand how can it be that we sell drugs for a third outside the United States.
They think we’re ripping off the people in the U.S. What’s going on actually is that Europeans are actually ripping us off. What’s the solution? That’s a structural problem that’s well beyond my pay grade. It’s way up in Washington to how you figure that out. There are some things that the administration can do with the stroke of a pen and put all this sort of chatter to bed. If you talk to people and you do surveys, people don’t care about the price of drugs. That’s just wrong. They don’t care about the price of drugs. They care what they pay, their portion for a drug. They don’t really care what their insurance company pays. They care what’s the co-pay. Seniors, for example, in part B drugs, part D is cut it down to $3,000, but part B, it’s sort of 20%.
That’s very, very, very onerous on a lot of people. With a stroke of a pen, the administration can basically say, let’s treat seniors the same way we treat people who are younger than 65 under commercial and let the companies bear the burden of the co-pay. The counterargument is that that’ll increase utilization and all that kind of stuff. Maybe people actually get treated better if they had full access to drugs. That can be worked out. This could all be put to bed by dealing with the co-pays because that’s the only thing patients actually really care about. I had a chance to talk to some colleagues on Martha’s Vineyard where I spent some silly vacation time. There’s an epidemic of alpha-gal there. Alpha-gal is meat allergy. It’s spreading around the country. It’s in North Carolina. Anyway, they asked, do you guys have a treatment?
I said, we do. They said, when can you get it? I said, you can. They said, why not? I said, we haven’t started development that soon, but I don’t think we’ll develop it because you guys don’t want to pay for drugs. That’s what pays for research. It sort of brought home the message. They all agreed, maybe they would pay for research if it hits home.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: All right. Maybe we’ll go back to some of the key kind of growth drivers here. I guess, you know, one question is we think about DUPIXENT. I know there was some competitor data out recently for another OX40. Maybe Marion, you could just give us kind of your view on kind of the key growth drivers for DUPIXENT here on the forward and how you think about this competitive landscape now that we have a little bit more visibility.
Marion McCourt, Head of Commercial, Regeneron Pharmaceuticals: Sure, very happy to. On DUPIXENT, eight indications in the U.S. marketplace. Seven of the eight, which is really impressive, are leading in both new-to-brand prescriptions and their total prescriptions. The only indication that isn’t at that status yet is CSU, which we only just launched but is off to a strong start. Other recent indication launch of CAPD going very well, helping a lot of patients with unmet need across all of our skin indications, biologic asthma, nasal polyps, eosinophilic esophagitis, all really strong performance. To your comment related to recent competitors, obviously, a number of companies have launched in the space of atopic dermatitis. The KOLs always tell me that DUPIXENT is first and best. I would share that the data and the performance we’re seeing reinforces that. As other companies are coming into the atopic dermatitis indication, they’re educating, they’re bringing more consumers into the fold.
That is really translating to more first-line business for DUPIXENT based on the efficacy, the safety, the convenience, and use. Indications obviously down for children as young as six months, older populations as well. With that really remarkable dual mechanism of action and the fact that we help across type 2 disease indications, it’s not uncommon for someone who suffers, for example, from asthma to also suffer from nasal polyps, atopic dermatitis, crossover with asthma as well. I think DUPIXENT really is helping a lot of patients. We still have a lot of unmet need, even in atopic dermatitis. We’re only probably penetrated to about 20% or so of the patients that we could help. To some of the recent data, I visited a couple of conference sessions last week, kind of live time hearing updates on Sanofi’s data. Sanofi is our partner with DUPIXENT, very important to us.
I do think most thought that the OX40 data was a disappointment based on efficacy, not unlike perhaps what Amgen had seen. Hopes were high that there might be differentiation there, but probably was a bit disappointing, not only in efficacy, safety, and certainly previously the OX40s have shown not to be efficacious in asthma.
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Time of onset was very, very late.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Just remind us the structure of that partnership. If Sanofi launches their OX40, they have to fund that fully separately.
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Fully leverage any of that, not leverage anything related. They can’t leverage the knowledge, the people, the product, no bundling or anything like that.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Would you be interested in a profit share if they approached you for that, so that you could leverage this across the portfolio?
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: I bet you in research in that bank.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: No answer. All right. The other focus asset in immunology that you guys have in your portfolio is itepekimab. Maybe just talk to us about how you potentially can leverage this on your existing infrastructure.
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Sure. Obviously, it was a disappointment that one of the trials conducted right in the middle of COVID didn’t confirm the other trial, which worked exactly the way we expected. We’re having conversations with the FDA. We’re trying to decide. In the meantime, we’re going forward with the nasal polyp story, which I think has a strong genetic backing and perhaps other indications. I think itepekimab is far from over. That is something that’s in the partnership, can be leveraged, and we will work together on.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: When will we get an update on the COPD side in terms of kind of go-forward strategy from you and Sanofi?
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Probably before the end of the year.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay. Could Marion speak to just some of the other opportunities in terms of the commercial set for that asset?
For garetosmab, sorry.
Marion McCourt, Head of Commercial, Regeneron Pharmaceuticals: Thank you. Obviously, tremendous opportunity. We are working with DUPIXENT now in the space of, you know, obviously, COPD and the understanding there. Different population for itepekimab. It would be very complementary and certainly a major opportunity. We look forward to the data, follow-up discussions with FDA. Certainly, the clinical data was interesting. Not complete. We have more work to do, but, you know, potentially a very important opportunity.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Yep. All right. Maybe we’ll pivot over to oncology now. You know, you mentioned a lot of the upcoming data sets here, Len, that you’re expecting. I think, you know, obviously, a lot of focus on LAG3 in general as a target. You guys are right here behind Bristol. As you think about the upcoming melanoma trial that we’re expecting data, I think, later this year, early next year, maybe just frame for us kind of what you want to see for success there and differentiation versus Opdualag. Maybe, Marion, you could just speak to the commercial opportunity in that setting.
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Yeah, I mean, I think we want to see a successful trial, which the primary would be against Keytruda, showing that we’re better than Keytruda in the combination. We’ll look at cross-study comparisons of what the combination of Opdualag looks like. First job, job number one is let’s win on the trial.
Marion McCourt, Head of Commercial, Regeneron Pharmaceuticals: The commercialization potential, certainly over the last several years, we’ve made a lot of progress with Libtayo in the marketplace, both U.S. and internationally. That footprint is important because, obviously, as we extend into hematology, as we have with Linozyvic, with Ordspono as well in the future, we’ve launched in Europe with Ordspono. We hope to launch Linozyvic in Europe shortly. In the U.S. marketplace, we’re making a lot of progress against both academic and community settings for oncology, which I think is really important, as we always said, for the platform of our future portfolio. We have additional clinical data following approvals. We have the commercialization footprint in the marketplace across many disease areas now and, hopefully, have shown you all the ability to commercialize successfully in the marketplace. As Len was talking about all of our future programs, we’re always working ahead on launch readiness.
Whether it’s a program in obesity, cardiometabolic, oncology, hematology, we’ll be at the ready to launch, often as we do today in very competitive marketplaces.
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: I mean, I can’t overemphasize. If you want to think about Regeneron Pharmaceuticals, of course, you’ve got to model EYLEA, and you’ve got to model DUPIXENT and think about what’s happening in those settings. That’s where you guys spend about 90% of your time. Where I spend an awful lot of time is on the pipeline. As I said, we believe we can deliver double-digit numbers of blockbuster drugs. We’ve got line of sight already into those. I’ve named about six or seven of them for you, and there’s more that we haven’t even talked about. We are very excited about that. We’re thinking about ways to get people to shine a light on that a little bit more. I’m not sure why people haven’t.
I mean, blaming you a little bit, Terence, and not you specifically, but your ilk because you guys do have an iceberg view of the world. It’s hard to chop down into 45 programs.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: As we think about maybe just LAG3, I know you guys have been optimistic you have a better antibody than Opdualag. As you think about read-through from melanoma to lung, I think that’s one of the other questions people have: how broad could this LAG3 opportunity be? When we see your melanoma data, how should we think about it in the context of the lung cancer opportunity? I think that’s one area in checkpoint inhibition that everyone’s been focused on for a long time, just trying to understand read-through from one indication to the next. Sometimes we’ve seen read-through, sometimes we haven’t. As we think about extrapolating to other indications, how excited or not should we be when we see this melanoma data?
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Yeah. I mean, I tend to be cautious in cancer about leading across indications. Obviously, I’m hopeful if you see strong data in one that it would lead to strong data in another, but I don’t think there’s a guarantee there. We certainly aren’t approaching that. You know, I think what you should see is we don’t like to make singular bets. At least we make them, but we like them to be part of 10 bets. If you think about what we’re trying to do here, we’ve created two of the biggest drugs in the history of the industry, internally discovered, internally developed, and marketed and developed with help from Sanofi. Those came out of our laboratories. To us, the way you have an evergreen company is to keep doing this. We did those on shoestring budgets, OK?
If you want to talk about read-through, the read-through ought to be, wow, Regeneron did this, EYLEA, and DUPIXENT on shoestring budgets, OK? The read-through ought to be when we say that we can produce another 10 or 15 blockbusters in a reasonable period of time because we already have the data and we have the know-how and the capabilities. I think that is really the most important read-through. Let me address some of this nonsense that I think is out there that Regeneron can’t get drugs approved and all that. There has been a big effort by the FDA to crack down on the filling component of manufacturing because a lot was exposed during the COVID era, how woefully inadequate the whole system might be. The FDA has been cracking down.
I wish we had, we got delayed building our own during COVID because a lot of long lead items we couldn’t get, but we’ll get our filling online next year. If you think about the setbacks we’ve had, for the most part, first of all, we’re very vocal and visible, you know, with us. Now you can look at all the other CRLs that people got because the FDA published it. With us, the big problem has been related to filling. We think that those problems should be fixed relatively soon.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: As you think about that filling opportunity, I know you guys have been moving this in-house, as you’ve alluded to. Is that going to be across the portfolio? What percentage of your filling can you ultimately accomplish as a result of this in-house effort?
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Let’s start with one line, which is a lot of big line, but there’s a lot of capacity that we’ll take back from Sanofi’s been doing most of the filling for DUPIXENT. We’ll take some of that back. That’ll take up a lot. We expect to put about four lines in place. Over time, it should handle our internal filling needs.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay, great. Maybe a little go back to the pipeline. You mentioned your C5 effort. You’ve got two different assets here, several different indications. I think this is one of those questions where the street’s debating the size of the, we know the established commercial opportunity, but how do you guys come in as a later entrant, differentiate, drive share, particularly if it’s, let’s say, PNH or MG? I think GA is still an open question. At least in those two, maybe you could talk to us about how you come in.
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Yeah, I don’t think it’s particularly hard. You think about what was paid for those assets, what Alexion went for. You can get an idea of what people think the value of that is. We did a head-to-head trial already. We know that we perform better than the other C5 antibodies. It’s just clear as day in the direct part of the study and in the crossover. I don’t know why none of you guys pay attention to it, but it’s out there for everybody to see, and that’s a big market. The myasthenia gravis, we have better data in terms of the efficacy. We are talking about a once every quarter self-administered versus a once a week or once every two weeks or whatever, or even once every eight weeks intravenous. You have to go to an infusion center, et cetera.
I think that efficacy and convenience and in myasthenia potentially safety because you’re not completely inhibiting the complement. I think that that’s going to win out. This isn’t, I don’t know why one would have a hard time thinking about that. That’s a well-differentiated product.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: How do you think about the size of the commercial, incremental commercial builds you guys need on this? Is there anything you can leverage currently, or do you need to build out de novo for these indications?
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Yeah, Mary.
Marion McCourt, Head of Commercial, Regeneron Pharmaceuticals: I can help on that. There are places where we do have some synergy. Now, across many therapeutic areas, for example, we’ve got a very strong market access and pricing team. We always build very carefully in a very lean kind of model, but we certainly have the skill set there to add in many future products in the portfolio. That certainly would be one. What we tend to do for the customer-facing model is we understand the program, the disease area, the customer needs, and then we build that model. You’ve seen us do that with Sanofi for DUPIXENT across indications. I’ll use an example. You made the comment about launching into a highly competitive market. Look at biologic asthma, where DUPIXENT came later. Ultimately, now with five competitors in the marketplace, it leads in new and total scripts.
It’s the strength of the product and the science for sure, but we also have been able to attract wonderful commercial talent to the organization on my team and our medical affairs team. I very much look forward to going to neurology, another specialty audience where you would have a fairly lean type of specialized model for promotion. We very much look forward to it. I’m thrilled with what I’m seeing in terms of the profile of our product for myasthenia gravis and then PNH in the future. GA, obviously, tremendous unmet need. The ophthalmology market is where we have so much heritage, reputation, and performance.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Great. Maybe just in the last couple of minutes, you guys did have a press release out this morning on some positive phase 3 data in your immunology setting. Maybe Len, you could just give us the highlights there. I guess the question I had is, are you able to file for approval on these two data sets?
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: Right. What Terence is referring to is that we showed that people who have cat allergy, and that’s a huge fraction of the population. Remember, you don’t have to own a cat to still get symptoms of cat allergy because cat dander is everywhere. Once there’s been a cat or somebody who’s had a cat comes into an environment, the dander is very sticky. People can be exposed even without going to cats. Plus, relationships break up over whether they get rid of the cat or not. Most of the time, the cat wins. I would say that cat allergy, what we showed there is that you give these antibodies that block the allergen, and you give it subcutaneously. You can wait a week. You can wait months.
What happens is if you put the dander in the eye, people get itchy, red, teary eyes, and you can have a p of less than 0.01 blockade of those effects. We do the same thing with birch. Whether or not we can file, I doubt we can file on these. We need probably a second study. I think the data was so strong. These programs have been dramatically de-risked. This needs to be, plus, you probably won’t get around to thinking about it, but it is pretty important how many people might have a cat allergy.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: How do you frame the commercial opportunity? Because that is one where there’s not a lot of analogues. I mean, maybe you could say like Xolair or peanut allergy. How do you think about the commercial opportunity?
Christopher Fenimore, CFO, Regeneron Pharmaceuticals: The way I think about it is how many people get cat allergy shots, which cost thousands of dollars a year and take years and years and years. They are very burdensome, and they do not work as well, I do not think, as this at work instantaneously. I think this could be a self-pay market. I do not know. We have not talked to the insurance, but certainly people, as I said, the cat usually wins. Whether you are throwing out the fiancé or the cat, the fiancé usually goes. I think that there is a real need for something like that.
Marion McCourt, Head of Commercial, Regeneron Pharmaceuticals: The early read in the market is that there certainly is payer reimbursement opportunity. To Len’s very good point, there also would be opportunity for consumer potentially in that space. These allergies can be remarkably severe for patients, and many, many patients going for regular treatments are not getting the results they need. These are life-threatening allergies.
Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Great. I think we’re up on time, but thank you so much, everyone. Really appreciate the time this morning. Thank you, Terence. Really appreciate it.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.