Now, some of you will have an older version of the itinerary and will realize that I don't have Bill Sibold sitting next to me. But rather than just canceling on us after Bill's amicable departure last week, Sanofi really stepped up and have given us two speakers. Really topical. Brian Foard, who did run Dupixent, and some of you have met him at the Immunology session last year. He's now the Head of Specialty Care, North America, and Country Head for the US. And Kim Tutwiler, Head of RSV Development. So very timely to have both of you here, and thank you very much for not just pulling out and coming. So, I'll try and make this as interactive as possible. Those that know me will know I always say this: Here to moderate, not monopolize.
If any of you want to ask questions, shout out, stick your hand up, or actually, I've been told in the back, wait for the mic before you ask a question. But before we do that, I think Brian wants to make some opening remarks, and then we'll go into some Q&A. So Brian, Kim, thank you. Over to you.
Yeah. First and foremost, a huge thank you. Thank you for having us. We're, we're really excited to be here. It is an important part of our journey with Sanofi, and it's a really exciting time to be at Sanofi. I think as we crossed the end of 2022, we were through the first three years of what was laid out, I guess it was in December of 2019, on the Play to Win strategy by Paul Hudson, that he laid out. So as we crossed the end of 2022, you know, we had marked kind of the end of the first half. And now 2023 is really a cornerstone year for us as well. And actually, if you think about what we accomplished before that, it was 10 quarters of growth. Obviously, our pipeline continuing to develop.
At the time, as we started this year, we actually put out a new or we actually said we would likely achieve the waypoint, the first waypoint of over $10 billion for Dupixent this year. We saw the first half of this year, actually, the pipeline continuing to develop with approvals, but also really positive readouts. So this was a really pivotal year for us as well. And so as we look forward in kind of the next chapter of this, Play to Win strategy, you know, that's a lot of what we're talking about here. Where are we going with Beyfortus? Where are we going with Altuviiyo? Where are we going with what our future pipeline looks like with amlitelimab and CD40 ligand and so on and so forth. So I'd say, really exciting time. I'm happy that I can fill in for Bill.
I've got the same haircut, luckily, so, so that was a pretty easy switch. But, but we really are excited to be here and answer all of your questions. I will make one last plug because some of the answers. Some of the questions we may get, might be better answered even in our December the seventh R&D Day. So we are gonna be having another, R&D Day, and it's a great opportunity for us to really go deeper into our pipeline, contextualize how we're thinking about each of the assets, contextualize the size of the market, the competitors, so on and so forth. So I'll make a plug for that as well.
Very good. Okay, so I have to do it differently. Everyone will want me or expect me to start with Dupixent, but, you know, you-- let's not do that for a change. But don't get-- I won't ignore it. Don't worry, Brian. But you know, in all the years I've covered Sanofi, I can't recall, you know, many drug launches, let alone three at the same time. And the one that I wanna kick off with, with you here, Kim, is Beyfortus, because ... And feel free to do your lap of your victory lap, but that ACIP meeting pretty much went best case scenario. So just to make sure everyone in the room is on the same speed as you, where are we? How did you feel? How do you feel about how that went?
What have you been doing from a launch perspective? And then I have a few follow-ups after that.
Sure, sure. So thank you for the opportunity to talk with all of you today. I'm very excited to be able to talk about Beyfortus. So this is a, a huge, this is a huge priority for us, and it's a huge passion for us because we set out on this journey a few years ago to try to figure out how to protect all infants from RSV. Because in the past, in the past 20, 30 years, it's really been thought of as just a disease that impacts premature babies and youngest babies, and the truth is, it impacts every baby. And so we set on this journey to get to exactly where we are today. We were really excited by the ACIP meeting, as you mentioned. I think this went ... But to be honest, we expected this.
We were confident that this is the way this would go, with a recommendation for all infants, and I'll contextualize that in a moment, just explain a bit about how that works. The Vaccines for Children funding, because the goal of this is to take a monoclonal antibody and to have it treated and used like a vaccine, so that it can have the impact across the broad population of all infants. That's never been done before, but in this case, medically, it's the right thing to do, because we need a solution for all infants for RSV, and this is the right way to do that. So to give a little bit about ... I'm just gonna describe quickly on the, on the market, and then I'll talk about what we've been doing in terms of preparation.
When you think about the market, the pediatric market of infants for RSV, there's really three groups of babies to think about. The first are the babies who are born during the season. The RSV season is November to March, and these babies need to be protected immediately at birth because they're born in the thick of the RSV season with the virus circulating. The second group are the babies who are born before the season begins. Think of a baby born in June, and by the time they get to October, they're a few months old, but they're still very naive to the RSV virus. They have no experience with it, they have no, no immunity to it, and they still need to be protected as they come into that RSV season.
And the third are babies that are born prematurely or preterm, so they need to be protected, and it's a bit. You can't predict that because you don't know exactly when they'll be born. The beautiful thing about a mAb as a routine immunization, a long-acting mAb, that is, is that it can protect all three of those groups, and that's exactly what Beyfortus does. And so one of the key things that we've been doing in terms of preparation for launch, this has been several years long. It's just making sure that that priority is known, that the education around which babies need protection, it's an easy answer. It's all of them that need it. But why? And helping to kind of explain that and make sure that's clear.
Since the ACIP meeting, what we've been focused on is making sure that providers are ready. We have had a several year-long journey with key opinion leaders. We have good support. I think they really understand the medical piece of this, and they also have a lot of passion for making sure that babies are protected. So we have a good core group of KOLs that are helping. We've also been working with our large, customers, our largest health systems, hospital systems, pediatric groups, to make sure that they're ready. Obviously, we're in close partnership with the CDC. The Vaccines for Children program is critical to this product being able to be used equitably across all infants. And so we're in close partnership with them and getting ready.
I think there's a couple of wins that have happened even, you know, kind of, as we come into the ACIP meeting and since, that are going to help the implementation. Some of the logistics of how you record an immunization being given, this has been worked out in good time and is very much like the traditional process for a vaccine. Same thing is true for coding and reimbursement. Those elements really matter for physicians to be able to use the product easily. So we have good progress and really fast progress there. And I think we're getting a lot of enthusiasm from physicians and from healthcare providers who are ready to get this done for the season. So what we anticipate is there'll be a catch-up period.
That's probably in October and into early November, where the babies that have been born so far this year get a catch-up dose. You know, they get immunized with Beyfortus to make sure they're protected for the season that is coming. That'll be in the pediatrician office. And then, starting with the in-season, babies born during the season, we have two opportunities to catch them. One is in the hospital, and that's for baby to be immunized before discharge, and so we'll work with the hospital systems for that. In the U.S. market, there's actually a very good opportunity. A few days after birth, baby goes to the pediatrician office. So if they somehow don't get immunized in the hospital, I do think the hospital segment will take a little bit to get up and running because that's a bigger change for them.
The pediatric office can catch that, a couple of days later, and baby is still protected. So we feel good about our ability to cast a good net. I'm asked often, you know, how do we see the trajectory and sort of how do we see the launch? So I'll say it because he's gonna ask me in a minute anyway, so I'm just gonna go ahead and go there. We have a couple of analogs that we've used 'cause we're trying to predict it just as you are. So the analogs that we've used are really Rota and Prevnar, to kind of look at historical first-year pediatric launch performance. These are very successful pediatric immunization launches, and so that's what we have looked at. And it's always gonna be progressive.
So as several of you have heard me say this maybe earlier today, but it's not like turning the faucet on, and everything automatically happens at 100%. It's gonna build over some time. But I will say that I think we have seen a lot of enthusiasm and a lot of energy, which we're really excited about because we have a lot of passion for this mission of all-infant protection with Beyfortus. So I'll pause there just on opening things, and we'll see what else Peter wants to do.
I've got a few. I've got a few. So then one thing you haven't touched upon is capacities, because I think we all know the numbers, 4 million, both birth cohort per annum in the U.S., something similar in Europe. There's China, 16 long term. Yeah, and also the mechanism, because now that this is on the national immunization program, forgive me, I'm not American, but, I believe the payers have a year before they, before they have to make it available. So it's not... You know, let's not get carried away, but if you do the simple math, which I'm good at, $400-$500, which is a price that was discussed at ACIP, ACIP, that was seen as sensible, I mean, you're looking at a couple of billion opportunity alone in the U.S.
The question is: How quickly can it get there? But also, can you on top of that, how limited, how limiting or not, is the capacity? And how will Beyfortus roll out beyond the U.S.? 'Cause you've got the approval in Europe as well.
Hmm. Yes, all good questions. So, two comments in terms of capacity. We don't anticipate any capacity limitations as we go. So we have a... You know, this is a partnership with our friends at AstraZeneca. I think we have a really good ongoing relationship on this point, so we don't anticipate any issues there. So I think that's the first piece. I think it will be progressive across all markets, not just the U.S. So what you'll see in this first year, in 2023, France and Spain will come on board with both all-infant programs in both these countries. We're really excited about that because those are also both heavily accelerated.
That really shows the passion, and I think the excitement and the energy that those countries had, 'cause normally, and if you've followed the French market, you know, it usually takes quite some time to get there. And I think they have really done the job of saying, "This is important. We need to accelerate it. We need to do it quickly." And so we're very excited about that for both France and Spain. We're obviously we have ambitions across the rest of Europe. I think we'll see a lot more of those countries come on board next season. I think we'll see countries throughout Asia and throughout Latin America, South America, come on board next season. The 2 next big ones are probably China and Japan, and so we anticipate those in the next couple of years.
China is probably the most interesting market because it's the one market that doesn't have Synagis. So they have the lowest RSV awareness, I think, around the world, because they have not had a solution that's been available to them. The other markets have had Synagis available, which, although it's just for extremely premature and high risk, there's some awareness about RSV, and so you just need to kind of help reset the thinking and the boundary on that. But China really is a bit new. But we will start a pilot there, a very, very small one, kind of a concierge-level pilot there this year. And we're excited about that because it will give us some experience in that market and start to help us understand exactly how we unlock there. But that's clearly a big priority for us.
Felix won't like me saying this, so the bar's been set by Sanofi in terms of the new launches, over $400 million, and the grading has been Altuviiyo, Beyfortus, nirsevimab. But from everything you're saying, it doesn't feel that you've set the bar particularly high, should we say? I mean, that it does feel that that is a, you're gonna smash through that, basically. I realize you can't comment and give forward-looking statements, but I just want to—given everything you've said, where am I wrong in terms of coming to that conclusion?
I think, in general, you're not wrong in terms of things that we got the recommendation, but those things were already baked in, to be honest. We were pretty bullish in the assumptions that we were making about that piece of it, to be clear. However, I think probably what we have to see, usually you do have a progressive uptake, so it does not go as quickly as you might imagine. So all the things that we're seeing are very good, and that's exactly what you want. I think it's going to help make sure that that curve goes as we expect, and we don't hit sort of snags along the way. I don't think it's gonna happen overnight. Would I be happy if it did? Of course I would.
But I don't think you're gonna see that overnight. So I'm not trying to say that it's different than what the guidance or the expectations you have. It isn't. We baked those assumptions in, but we were also pretty bullish with the assumptions we baked in.
Okay. Okay. And then just, finally, just to round out the discussion on Beyfortus, you've got your friends at Pfizer with their,
Yeah.
their maternal vaccine. I'd love you to... Yeah, how you're thinking about the positioning relative market shares or just what the advantages are. And then just generally speaking, I mean, there's a little bit of COVID fatigue, right, in terms of vaccination rates. Is it just because it's involving kids that you think that's going to be less of a barrier or there'll be less inertia? Or do you, do you accept that that will probably be something that holds you back initially in terms of raising awareness and getting people, getting buy-in from doctors and, and new mothers?
Yeah. Both good questions. So I'll start, actually, I'll start with the what, with the second part, just to round out the coverage rate immunization expectations, and then I'll talk about competition. So yes, we do anticipate that part of turning the faucet on is not just the logistics and the providers, but it's also the making sure that the willingness is there, and that you don't have any sort of big resistance. With pediatric vaccines and pediatric immunizations, what we have typically seen is the pediatrician recommendation usually wields the most power. So it's a little less if it's adult immunizations. Adults make their own mind up at that level. So I do think you see a lot more COVID fatigue there.
I think you see less of it in the pediatric space, but I do think it's still there, and I think probably more so about questions. And in fact, one of the things that we've been working closely to prepare for customers and, and to make sure folks are ready is: how do they explain this is new, what is it? And how do they explain it in the right language, in the way that makes mom very comfortable with, with what they're getting? So I do think that will be a factor in terms of the, the curve, a little less so in pediatrics than adults. On competition: So the Pfizer maternal vaccine will have a recommendation from ACIP later this month. I think many of you probably know.
What I would say is I'll give just a view of what can and can't be, just from the profiles of the products, and then I'll talk about what we've heard ACIP say so far. It remains to be seen what they'll say in September. I mentioned earlier that there are three groups of babies to think about in the pediatric market: born in season, born out of season, premature. A maternal vaccine has the ability to protect babies born in season. It does not have the ability to protect babies born out of season or premature babies. And that's because it's timed to the birth and not the season itself, and the duration of protection is not long enough to last. So that's a class effect, I would say, from a maternal immunization.
Pfizer specific product, I'll let them, I'll let them speak to that. I think there have been some questions from a safety perspective, and the label is pretty narrow in terms of the period of time when mom can get immunized. And so practically and pragmatically, I think that's a bit of a challenge, but let's see how that plays out. What ACIP has said, when they talked in June about both products being considered together in terms of the guidance, is basically that there are scenarios where if a maternal vaccine was given, you'd still need to, you would have either the freedom or maybe you would want to also give Beyfortus. If you can't validate that mom was vaccinated, if you're not sure when she was vaccinated, was it in the right amount of time for antibodies to build and be transferred?
Do you feel the baby is, for any reason, at high risk? So there's a bit of a judgment call. I don't think anyone would say from a health economic standpoint, that it makes sense for both products to be used together all the time. But what I would say, practically speaking, is this: if you're a physician, you will always need to have Beyfortus on hand. You do not need to have a maternal vaccine on hand because all three groups can be addressed by Beyfortus, but all three groups cannot be addressed by a maternal vaccine, if that makes sense. So let's see what their guidance is. We feel confident.
Most of the time, a recommendation is obviously the really important driver, but also the profile of the product and the efficacy and the safety of the product are critically important to getting choice from providers. So we feel really confident with the profile of Beyfortus. So I don't know if that helps, but just an overview.
Very clear. I'm gonna pause before I move off, just to let the audience, if there any final questions on Beyfortus. Okay, no. Brian, back to you then. So Dupixent, lots to discuss. I won't throw a sort of multi-part questions. Can we, you mentioned you're already well on track to be over EUR 10 billion this year based on the H1 numbers. Could you just brief the audience, the trends that you're currently seeing, whether it's atopic dermatitis, asthma, but just current trends, how you're feeling about how the second half has started for Dupixent.
Yeah. So again, it's another interesting asset where, you know, the science leads us. You know, I mean, at the end of the day, and that's what we're continuing to see as we've rolled out. You know, this year is a lot about those foundation indications, which we've already been indicated for, so atopic dermatitis, asthma, and nasal polyps. But it's also about, it's still really the first full year of launching continually in EoE and prurigo nodularis. That speaks specifically in the U.S., and we're now starting to see some of those approvals around the world and launches around the world in those indications. So it's kind of the... We're still just as we like to say, we're still just getting started. So the growth rates, where is our sources of growth coming from?
Well, first and foremost, it's coming from there's low advanced therapy penetration, which we've pretty consistently said is first and foremost in those foundation indications. So atopic dermatitis. Still roughly around 12%, if you think about it, in the adult population. If you look at the overall population, now we're down to 6 months of age, it's still roughly just over 9%. So that's a long way to go before where we, we think it's going to get to roughly 25%-30% when it's all said and done. We're going to see that continue to, continue to grow. So that's a big source of growth. And then when you think about market share, you know, again, we get a lot of questions about the competitive landscape. It's like, oh, the atopic dermatitis market's about to get competitive.
Well, we've seen some incredible players come into the space with multiple assets over the last several years in atopic dermatitis, and what we still see there is, as we've, you know, indicated before, we continue to see that Dupixent is the preference of... You know, when the physicians reach for the therapy of choice, it's going to be Dupixent for these patients, and it's based on both an efficacy and safety profile that's extremely well balanced for this patient population. So I don't see that changing. So as you look to the second half of the year, what we've continued to communicate is that our growth is going to come from continued growth in the indications that have been out there for a while, complemented with the new indications that we've just launched in. So eosinophilic esophagitis, prurigo nodularis, kind of adding on top of things.
And then the geographic, you know, side of things. So the wave of kind of, we're seeing kind of consistent trends as you would typically see as you launch around the world. You know, every time that we launch a new indication, it starts back in the U.S. first, and then you launch around the world, and so you continue to see that kind of wave indication by indication. So we're seeing really positive growth ex-U.S. as well. We've seen, you know, Europe is, is well on track to be, their now run rate is over EUR 1 billion. You see ex-U.S. is well over EUR 2 billion now, run rate-wise. So, we're very confident and we're seeing very good trends about how it's rolling out.
Pretty typical to what you would see, with any other kind of advanced therapy like this from a, where is your growth coming from? So still feel very good about, Dupixent. Still the beginning of the journey.
And then just on COPD, let's not talk. I think everyone around the room knows the BOREAS data. Let's not repeat that. But I think the questions that everyone wants to ask are the obvious ones. Number 1 , every time since that data dropped, it was great data, people have asked, "Are you going to be able to just file on a single study?" And it's been, well, we have to have those conversations with the FDA. So given I've got an opportunity, you're here next to me, have those con- where are we on that? Or is there no change? Number 2, on NOTICE.
Mm-hmm.
Now, I believe BOREAS was done during COVID, NOTICE wasn't. Apart from that, they are pretty much a clone of a trial, but just, what you don't want to see is, one, BOREAS great and suddenly a mismatch. So if anything gives you confidence that that will not happen. And then just from a commercial perspective, I mean, as you said yourself, Dupixent's now $10 billion. It's accretive to the BOI margin after the pay away. When you launch- when you think about the commercial footprint and, and your, your area of expertise is North America, do you need to add to that to launch in COPD, or does your asthma team get you- I mean, can you leverage the asthma team, or does that require another field force to add on top? So a few questions there, but let's, let's-
Yeah, and I'll kind of start with the strategy first, which will start to address your last part of your question. I'll kind of come back around that way. It is if you think about this asset, again, first and foremost, we, you know, this is living that kind of first-in-class, best-in-class type of breakthrough science that's going to transform patients' lives. You know, this is really at the foundation of Play to Win, if you think about it, even though that was rolled out shortly after we had launched Dupixent. We've really followed the science there, and we've learned as we've gone. Really, it is about treating those diseases that are driven by underlying Type 2 inflammation. And so again, if you thought about if...
Again, the way we articulated this before in the past was there were some anchor indications that we went after, so such as atopic dermatitis and asthma, and then very quickly, we moved to this whole host of other disease states that would be adjacent. So we thought about it very strategically, that would drive efficiencies as well. You didn't just, we didn't do kind of a string-of-pearls strategy of wherever it works, we're going to go. It's very much a dermatology strategy. It was very much a respiratory strategy and very much then we've moved into gastro. So kind of to answer your question on COPD, you know, we thought about that with COPD whenever we took the bold move to go straight into a phase III, even in COPD. And lo and behold, obviously, it worked, the science worked.
So that community has known us for a while. You know, those individuals that are treating those patients, those respiratory patients, asthma patients, the pulmonologists, we've now been in their offices for quite some time. But I will tell you, I'd be remiss if I didn't say: Will we invest behind this launch? Absolutely. You know, we've invested behind each launch, but there are efficiencies there across the alliance which make a lot of sense. But this is a community that knows us, that trusts us, that we've built that over time.
And so I feel like we're in an excellent position, not only in the U.S., but other major markets around the world, that when that indication does come, we will be extremely well positioned to maximize it without it being, "Hey, you know, nice to meet you for the first time." You know, as you think about just a bunch of big questions, I'd say, first and foremost, it starts with, again, this was a bold type of move to go into this disease state. Third leading cause of death. Nothing's really worked in this particular space. It's kind of a graveyard of previous assets that have tried it, and our trial is on top of background therapies, and this gets to the confidence of the drug with a second trial. You know, those other agents that these patients were on are very effective in COPD.
They're triple agents and so on and so forth. It's about as severe as you can get or effective therapies as you can get before going to a potential biologic like this, which they just don't simply have. So the fact that the data was that good on top of that, really, almost no matter when the trial ran, gave us a great degree of confidence that, you know, you've got a second trial, that, yes, there are some differences between the time period, and we'll have to see what that, kind of how that plays out in the trial. But we're very confident in, in the, in the data, I'd say, in, in a second trial.
When you're talking about a 30% improvement in exacerbation rate, annual exacerbation rate on top, you see the lung function improvement, you see quality of life improvement, the hierarchy really didn't break. So, that coupled with then getting to the FDA discussion was, of course, then they wanted to talk to us. And so across the lines, we had the discussions with them, and they gave us breakthrough designation, which what that means is, of course, we get to talk to them more. You know, we get to have that conversation back and forth. The base case scenario is still remains the same, is that they expect us to have two replicate trials to file with.
So that means NOTICE will be done. We'll be filing, so we'll see the readout in the first half of 2024, file second half of 2024. That's kind of the base case. But of course, we're having discussions with the FDA to say, okay? What would be acceptable? Would there be some type of interim analysis that we could possibly run? Would that be acceptable to you? Then we'd have to be comfortable with the risk that might be associated with doing something like that before we would ever consider doing anything like that. So again, base case remains, but the Breakthrough Designation is an important thing to open up that dialogue, because we do share, and the FDA was very clear about that.
We do share a common interest of bringing an innovative medicine to patients who, today, really, there's not many options past the therapies that they're on and still exacerbated.
Clear. Just it's a Dupixent-related question, but I want to come to another comment, because we are at this sort of transition period where some of the, you know, Sanofi's about to step into a new paradigm in terms of outlook on, on top-line growth, driven by the growth drivers and, the new products and some of the, you know, the headwinds, like Aubagio and insulin pricing, going into the rearview mirror. But the one—when I think about the, the market, a key debate in the market, with investors, particularly for next year, is this, you know, Mepolizumab launching, the underappreciated threat from an aggressive bridging program. I mean, if I look—we look at the net price of Dupixent over the last five years, it's been rock solid. It's been pretty stable.
So the idea that we hear the argument about where penetration is on the market, the breadth of indication, I get that, but just the loss of patients to a very aggressive bridging program. So could you just give your perspective as to, you know, whether that is... Again, we reflect some of that in our numbers. We still get to a huge number long term, but it does lead to an impact in growth the next year. But just whether you think that is a misplaced concern, and if so, why?
You know, again, I think it's always going to be a concern anytime you have a new competitor, and that's kind of why I said what I said at the beginning, is that we've seen competitors come into the place. We had some of the same questions. You know, each of these other competitors knew the space. They all came with the correct types of programs at the very beginning to gain trials from the physicians and from patients. We've seen those. We have similar programs, by the way. I mean, it's just as easy to go to the clinic right now and get Dupixent. You know, we have great coverage, great bridge. We have a great option for them as far as free goods goes or program that we have.
Patients that have, you know, lower economic status, they can actually get Dupixent as well. So we have great coverage. Pretty easy to get Dupixent if that is what, in fact, the doctor believes is right for you today. So it's hard to believe that no matter what type of program a company would put out there, that would make it that much easier to get another product, quite frankly, and we've seen that before with the other agents. So that's why it gives us a great deal of confidence with that. Again, but I still do come back to it, that we've seen the analogs with psoriasis as well. Every time a new asset comes into the marketplace, we're hoping for that part of the market growth. I think I got challenged in one of these meetings one time.
It was, aren't you hoping for competitors because they will help grow the marketplace? And that is true. You know, they will. We've seen that. But at the end of the day, it still will come down to why would I choose one versus the other? This one, it's as we have said before, same thing with Tralokinumab. We've seen another IL-13 come into the marketplace for over a year now. This is coming from a dermatology company, with LEO, so they know the dermatologist community quite well. They had an aggressive bridging program as well, from the very beginning, and, you know, we've seen what that asset has done over time. So it's still... The mechanism is just incomplete at the end of the day. So we're very confident with where we are, but we're not going to take them lightly.
Lilly's a great company.
Okay, last two on Dupixent. I'm just pausing any questions in the room. The last two questions on Dupixent, they're probably not your wheelhouse, but is there anything to say? I mean, Jean-Baptiste mentioned a couple of years ago, and Paul likes to tell everyone that wants to listen, that you got the Humira lawyers looking, the lawyers that did the Humira IP now looking at Dupixent. Is there any word or developments on the IP situation on Dupixent? And then from a strategy perspective, yeah, we're going to see more OX40 data. Sanofi is very keen to highlight that as being maybe not first in class, but definitely best in class.
Mm-hmm.
Yeah. How does that fit into, you know, if you have Dupixent and now an OX40, maybe even a BTK, how you think about the positioning of those respective assets within immunology?
Yeah, and really, as it relates to IP, I mean, obviously, this is something very, something very important to us. I'll let the lawyers and others sort that out, but we still got, like we said, we're still very much at the beginning of the journey. We've got some time, but we've been thinking about that, and that leads to the kind of the OX40 ligand discussion. We've been thinking about this journey for a long time because we've seen other companies go through it. You have the great success of an asset, and you need to already be thinking about what life might be like after that asset.
And again, I can't imagine life after Dupixent, quite frankly, today, and luckily, we don't have to for quite some time, but we have to think about it for a while, up to and including the types of deals that we did, the Kymab deal that we got, that we did to achieve or to acquire Amlitelimab. So, IP, IP aside, we've got quite a good runway still to go there, and I'm sure there'll be updates on that as kind of how the lawyers, I'll look to Roy and those guys to sort that out, and across the lines. As it relates to, you know, OX40 ligand and Amlitelimab, I think it first and foremost starts again, back to the science.
We had a brilliant group of research, a research group that was a precision immunology group that really looked at this and said, "Hey, this is based upon everything we know about atopic dermatitis disease state. We know about the science here. You know, this is gonna be an interesting mechanism," you know, because it's a very heterogeneous disease state, and we're learning a lot about atopic dermatitis. It's a big patient pool that is still, like I said, massively underpenetrated, but it's extremely heterogeneous. So we think, you know, having an asset like this that is, and again, specifically as it targets the ligand, it's a little broader than Dupixent from a mechanism of action standpoint, but very specific on the ligand, bringing these patients back to kind of homeostasis.
You could be looking at an agent that actually more broadly treats, but beyond the type two patient population from an atopic dermatitis standpoint. So then, number 1 , it's a little broader patient population. Number 2 , because of the mechanism there, we actually believe you could have a durability of effect that's quite substantial. You know, you could be thinking about much less frequent intervals of dosing to where patients can almost forget they have the disease for a period of time, which would be incredibly pleasant, I think, for the patients, while achieving a certain level of efficacy. And then, like I said, I always come back to, you know, this is going to be a marketplace that's always going to have a big spot for Dupixent. Like I said, I can't imagine it without it because it's such a big marketplace.
I foresee Dupixent continuing to grow, and OX40 ligand will be just another class that comes in that helps us grow that penetration rate that we've been talking about. Kind of like what you've seen, frankly, in the psoriasis space.
When you talk about durability or the treatment frequency, are you talking scarcity like once every three months or beyond that?
Could be. I mean, we'll have to see. The data will have to sort that out, but that is absolutely what we are. We believe the mechanism could do. And again, that could be something that the marketplace would see as valuable later on in, in the development of this marketplace.
Great. We won't ask you or grill you on to the other, unless you want to say anything, but Altuviiyo, I realize it's not your wheelhouse, but it is a, it's an area of focus.
Yes.
It's topical, given the launch and upcoming datasets with Fitusiran and the gene therapy story. Just as a shameless plug, we're hosting Professor Gary Kupfer after this session in the governor's room to talk all things great and beautiful about hemophilia. But anything you're willing to say on how that launch is going? Anything that you would like to share with the audience?
I'd say before, I know you mentioned to me it's not in my wheelhouse. You know, obviously being at Sanofi and talking about being the world leaders in immunology, I think Tzield is a really interesting immunology asset. You know, this is that first-in-class, best-in-class type of therapy that we're thinking about.
I'm going to switch mics.
Yeah, please. No problem. It's okay? Good. So before I leave that again, I'm not the subject matter expert to go too deep on that by any stretch of the imagination, but that is very much in line as we talked about our kind of leadership in immunology around the world. That is an interesting type of asset where, again, very high medical need patient population, first-in-class, best-in-class, and with dosing, could you actually delay the onset of, of type one diabetes? That's a pretty interesting... Now we've got to unlock the marketplace, reeducate the marketplace, as we've seen in a lot of different areas. But, I think that's also one that fits very nicely into our strategy. As it relates to Altuviiyo, yeah, this is very much in my wheelhouse now, in my, in my, my old new job.
My old new job in the U.S. actually was right at the time that we were launching Altuviiyo in the United States. And so, yes, I've entered into the, to the rare blood space, and it's been really exciting, to be quite frank. I have not worked in that space in my career, and what I've seen is it is a community. I mean, it is a really impressive community, whether it's the physicians, whether it's the individuals that have chosen professionally to work in that space, the patient population. And so we're very pleased with the launch of Altuviiyo thus far. Now, again, this is a patient population, this is a physician population that is... Again, as I said, these patients are on therapy, so that's a switch market.
And so we've really had to go in there, as we said from the very beginning, and really point out the difference of this particular agent. You know, with the once-weekly infusion, bringing patients to near normal factor levels, to where for most of the week, to where they can really live their life and be active and not worry about those breakthrough bleeds the same way that they have with most of the therapies out there. And you can see that's really starting to cut through. What we're seeing so far is that we said this even in Q2, was our target audiences, which is a pretty target-rich audience. Over 80% of them have already prescribed Altuviiyo, number 1. Number 2 , about 70% of the switches from factors are going to Altuviiyo, so it's already now the choice from a switch standpoint.
Two-thirds of our switches are actually coming from competitors, as we also, I think, previously communicated, and actually 10% of that is actually Hemlibra. So factors make the most obvious switch sense. Hemlibra, though, we've seen the, obviously, the efficacy message is holding, or it's become very important for both the patient and the physician community to see that type of switch as well from Hemlibra. So we're very, very pleased with the launch thus far. Still a lot of work to do. It was a busy summer, but, but off to a very good start.
Good pause here. Any questions before I change subjects? As we enter sort of the final five minutes, just a couple of high level, and I'm not realizing you can go give the definitive answer, but I would be interested. I mean, IRA, right, hit the here and now of it. IRA is not, you know, Sanofi is probably more on the least impacted end of the scale than the most impacted. But it's more than just the here and now. It's about how it's, how it's changing the discussions that you're having as teams, thinking about, you know, pipeline, capital allocation, BD. So can you just share with us, sort of, you know, not the, the ins and outs, but just how it has changed the thinking within Sanofi about, going forward, capital allocation, et cetera?
Yeah, I think first and foremost, as you said, you know, Sanofi is... We're not one of the drugs listed in the first ten group. Certainly as we think about the future, we have a low exposure from a government reimbursement standpoint, so we're in a really good spot, as you said. But I'd say how it's, how it changed is it's in every conversation like this. It's in every strategic conversation that we have. It is a part of now how we have to think for the future. We have to think about, you know, what does this mean for that particular patient population?
Because, again, we're concerned about, you know, how do we get innovation to these patients still at the end of the day, but how do you do it in a way in which it's gonna still be adding, you know, value from an organization like ourselves? So I'd say it's in every strategic discussion, but every one is a little bit different based upon where the disease state is, where the science is heading, and so on and so forth. But, put it this way, there's very few conversations that it's not a part of anymore in strategy, and it just simply wasn't the case before that happened.
And then this is a cheeky question. The R&D there, you gave it a plug. You want to talk about the science. There's an opportunity for the new head of R&D to, you know, to sort of, make his mark. I think he starts as early as October. But we're now four years since Paul and Jean-Baptiste and the team stood up and talked about, you know, BOI margins and free cash flow. And given where you, you said yourself, that was the first half transition year in 2023, new story in 2024. So just feels a little bit backward-looking to have midterm targets for BOI margin and free cash flow focus. So-...
Dare I ask, you know, at what point do you think Sanofi will choose to perhaps, you know, provide a new outlook to the market as to what their aspirations are and move away from margins and free cash flow to perhaps growth top line?
Yeah, and again, I think I'll you know, I'm very fresh into this interim role, so I'll try and keep it that way. So I won't say anything necessarily outside of what's already been publicly communicated, which is, you know, whenever we see the valuations of Sanofi continue to change, like, in other words, each and every one of you say that it's working, what you're doing is working, and the valuation comes a little bit more in line with what we think it is. You know, I think that's what Paul has articulated before in the past. It's almost like when you tell us that it's the right time to stop talking about that, then we will. But I do. I will say that I'll go back to it.
It's less about the number for us and how we operate on a day-to-day basis, is we have started thinking about the modernization of the company, and you think about the types of assets that we're now launching versus the Sanofi type of assets that we were launching back in the day. And it is a different type of organization that's required to do that. First-in-class, best-in-class type agents, sometimes really competitive marketplaces. And I think that is as much about the margin side of things as it is, are we fit for purpose for being able to launch these types of assets? So that's kind of my extra point that I would add to that.
And that actually feels quite good from a cultural standpoint, having been in the company now a little over six years, to see that transformation, which we don't talk a lot about here, because culture is one of those things that you kind of feel when you're inside of it. That's as much about that journey as it is, I'd say, you know, what we say as far as margin goes.
Very fair. I've been cheating you, given your new role is only about a week; it's a bit unfair. But look, you wrote one area, obviously Specialty Care, neurology. We've got Aubagio coming off. There's even tolebrutinib next year. The CD40 data did look pretty cool, and that's going into phase three. Now, Sanofi was mentioned as a potential bidder for Reata. You're not going to comment on that, I know that. But, yeah, from my perspective, you've got a period, you've got Aubagio going now, and you've got Tolebrutinib and even CD40 post-2026. So having a neuro asset to sort of bide the time, so to speak, is sensible. But given your new role, how are you thinking about neurology now?
It's a bit of an unfair curveball to throw at you, but, look, it's, it's an important part of the, the story, so anything you want to say on that would be helpful.
Well, not, not unfair at all. I mean, actually, in my U.S. role, we were thinking about... You know, we talk about this a lot, and actually, I don't, I'm not sure how we've talked about that before in the past, but I think what you can see, just what we've shared up here on the stage today, and there's a lot more behind this of other team members that have a lot to share about what's going on in the organization. There is a lot to do in our organization now. That's why I say it's very exciting. It's not like, you know, our growth rates are... You, you've seen them, right? Looking backwards. And we're very bullish about what they might look like moving forward.
So I would say it this way: we need talent, and there is plenty to do in this organization, and that team has proven that they're incredibly talented, and they know what to do with great assets. They helped build, quite frankly, what Sanofi became, I think, in Specialty Care, with moving into a very competitive neurology space in MS. So we have found, in the lack of them needing to do what they were doing before, in most cases, we have found incredible things for the ways to deploy them in little drugs like Dupixent, and, actually cross GBUs. We've actually had some talent go across GBUs. So we don't let go of talent very easily. We find things for that talent to do that makes the most sense at that moment.
It's again, another really great thing I think about our culture, is, we try and repurpose that when it makes sense to repurpose it, as opposed to saying, "You know, we're done with that for right now. We'll see if we can find you a little later on." Now, the good news is, we know where to find them whenever we need them again in neurology space, which, if you look at how our pipeline is developing, we will need them again before too awful long.
Any final questions from the audience before we wrap up? No? No problem. Kim, Brian, thank you very much. Good luck in your... Well, you're established role, but good luck in your new role, and look forward to charting your progress over the coming quarters. Thank you.
Thank you very much.
Thank you .