Right. Thank you. This is session three in the European track here at the Jefferies Global Healthcare Conference in New York. It's my pleasure to have Sanofi here. We've got Aayam Lamichhane, who's the Global Head of Immunology Commercial, and we've got Thomas Triomphe, who's the Head of Vaccines North America. Little bit challenging because I've tried to bridge those two topics in 30 minutes. I'll try to make that work. Maybe if I could start to the both of you, the one or two commercial priorities you most want investors to understand for 2026 and 2027 in your respected areas, maybe starting with Aayam.
Yeah, I can kick off with immunology. One of the key takeaways for us is currently we are running five phase III in immunology, all publicly disclosed. Recently we had the data readouts from our bispecific program, lunsekimig. The data will be presented second half of the year. That was in CRSwNP and asthma, and hopefully moving that into phase III as well by end of this year. Plus an additional one, rilza. We've had the data out for a while. Looking at potentially another three more additional phase III starts this year, getting the total up to eight. For us, that's progress in pipeline, one way of looking at these many number of phase III starts.
Fantastic. Thomas?
Sure. For vaccine in terms of commercial priority, I will start with Beyfortus. As you know, Beyfortus is our MAB to protect all infant against RSV. We've had a great last years. I think right now we have still potential for continued growth over time, either with coverage rate and more importantly with geographic expansion. We're going to launch in 15 more countries in 2026. I think Beyfortus is an important asset to watch. Of course looking at flu, COVID, how it's going to evolve over the coming years. I think our strategy is working, showing the value beyond vaccines, protection beyond flu and value for Nuvaxovid vaccine. These are some of the top priorities we have commercially.
Yep. I'll definitely go back to some of those. Thank you. I think I'll go one for one immunology, one vaccine, see if that works. In immunology, if I had to ask you sort of the one slide strategy for Sanofi, how would you describe that?
We had the R&D day back in 2023, how we're going to really focus on our core therapeutic areas where we have core competency, and we defined that as dermatology, respiratory, and GI was the third one with our TL1A transaction where we are making an entry. In dermatology, as you know, we are the leaders in atopic dermatitis, so we created that market and maintaining the leadership is absolutely critical for us. Within that, we identified another opportunity where we could leverage our existing infrastructure, and we have identified that as HS, high unmet need disease, multiple programs in development, and we have disclosed, as you know, so far two programs in phase II-B. One is brivekimig and the other one is our IL-1R3 program. That's our dermatology.
In respiratory, again, we are the leaders in respiratory immunology today with asthma, nasal polyps, et cetera, and amlitelimab being the latest from a data standpoint, how do we bring the follow-on programs? COPD, of course, the first biologic to be approved was DUPIXENT. Again, how do we maintain those leadership? Those two, for us, that's our core competency areas. GI is the area we have really going in, making an entry, partly because that market is so dynamic, and it's forecasted to nearly double by 2035. The unmet need, the remission rates are still so low, and we saw an opportunity to make our entry with our TL1A assets, and you've seen the data so far. Those are our three core pillars, and then we continue to explore high unmet need diseases which are closely adjacent to those therapeutic areas.
That would be how we're approaching immunology.
Got it. Thank you. Thomas, I guess to you, we're in New York. We all know the sort of backdrop, the market backdrop in vaccines that we've had over the last 12 or so months. If you think about sort of demand drivers as you plan for the next one to two seasons, has anything structurally changed? How do you think about the variability? How do you do the planning? What do you think about vaccination rates, public sentiment?
Yeah. It's a great question. I think there's a difference to be made between short-term and the mid-long-term. On the short-term, of course, the policy in the U.S. is complexified a little bit. The coverage rate, but it's been worked on and I'm confident that the demand driver are there and they're very strong. There are a couple of them. One is, unfortunately, if you look at the infectious disease prevalence, they are still there and growing. Look at flu and COVID. Flu, we had the last two seasons were the worst of the last 15 years in terms of burden of disease. We have anywhere between 50,000 and 130,000 people dying from flu every year. This is massive. You look at COVID the same. You look at measles that's coming back. You see pertussis, you see meningitis, you see all these diseases unfortunately are coming back.
There's going to be a reaction to that. The only good reaction, vaccines, and people know it. That's my second point. If you look at the polls data, you look at what American people think of vaccines, they overwhelmingly support vaccines. Whatever the side of the political spectrum, you have more than 70%-75% of Americans who don't want anybody to touch access to vaccines, including people more on the MAGA side of the equation. These are some very, very strong drivers that over the mid, long term will play out for coverage rates to come back like we've seen before in the years. We just need to navigate the coming few quarters, as we discussed, but I'm very confident.
Maybe just a quick follow-up. Obviously, RSV, Beyfortus is one of the questions this year. At what point this year do you think you're going to have visibility and clarity on what the demand looks like?
Yeah. RSV for infant, I guess, which is where we are present with Beyfortus. We are right now in the midst of discussion with customers. The immunization will start after summer, so we will know about the year much later in the year because immunizations happen September and mostly October, November, December until March. I think we are working very hard with our customers as partners to increase coverage rate, working on protocols, working on all the high-tech tools that exist out there to drive immunization. Right now, RSV infant coverage rate in the U.S. is 55%. 45 points of this 55% uses Beyfortus. We think over three to four years, we can grow that 55%- 70%+ . There is room and there is a public health need.
It's just going to take some hard work that we're doing right now to keep growing immunization rates against RSV in infant.
Thank you. Then back to immunology, [Shaji]. You talked about rilzabrutinib. When I speak to investors, when they think about Sanofi and immunology, it's obviously mostly DUPIXENT that people talk about, which is clearly not correct, but that's their perception. It's an interesting twist around rilzabrutinib because you kind of went the rare disease-ish angle on that. Higher price, not the big prevalence, but the value of that franchise, I think, is underestimated by people. Is that more broadly applicable in the way you think about immunology? Does lunsekimig fit into that pocket as well? Is rilzabrutinib just a one-off because it offers itself as a more of a rare disease setting?
That's a really good question with rilzabrutinib. If you look at when we acquired Principia, the transaction, they had already started ITP studies and a typical biotech, they went after high unmet need, high value. In our hands, we followed the BTKi biology, first of all, we're looking at a dual brand strategy, without going into a lot of the details, we had different formulations to capture the rare disease, high-value disease areas. Also, if you want to take into a broader, like asthma immunology, we have a completely different formulation, different dose. We have a full strategy in place to capture both ends. Right now, we are following the science, the biology, to maximize the value. With rilzabrutinib, as you know, in rare, we have already disclosed ITP, wAIHA, and potentially exploratory on sickle cell.
We have all those opportunities, but we have the ability to flex two different formulations and two different doses. We can go both ends of the disease spectrums and value spectrum. That's a Rilzabrutinib. On the lunsekimig, it's very much a bispecific TSLP/IL-13, and we are following the science we have generated so far. We have data in nasal polyps, now asthma. Asthma data also informed us on our COPD program, which we announced we are going phase II-B/III straight into phase II-B/III in COPD. That informs us how the mechanism is working, and once we announce the data for asthma nasal polyps second half of this year, you'll see more clarity on what our thoughts are on that mechanism and where we can take it forward.
Yeah. Maybe a quick follow-up on the COPD push. Obviously, we haven't seen the detailed data yet for tozorakimab from AstraZeneca, which I guess we'll get at the ERS. Does that data change the way you think about lunsekimig? If that does work across EOS levels and across patient population, what does that do for your strategic options for?
No, I don't think that would change our thought because both TSLP and 13 are validated mechanism in COPD now, right? We've seen the tezepelumab data in COPD phase II. They're in phase III now, and that was a really good for us. We learned so much from that phase II data. We know the TSLP cutoff for 150 EOs, et cetera. You can see that from the phase III design. The 13 is a mechanism we already know. I think what we needed to know, we have the data in hand. Now we have our own phase II data in hand. I don't think it'll change our view now moving forward in COPD.
Got it. Thomas, back to you. You mentioned the COVID flu combo. Can you talk a little bit about sort of the coordination effort you have to have between COVID flu, RSV? On that respiratory side of things, like as it becomes a little more complex, is that something I need to think about as I think about the season this year into next year? Or is it more of a continuum?
I think there are two dimensions in your question. There's the value of combo itself, and then there's how it fits the overall schedule for adults and infants. I can start with the combo value itself. I think there is value in combination vaccines. We happen to be the world leaders in combination vaccines. If you look at pediatrics, we have VAXELIS, Hexaxim, you name it. In adults, there aren't combination vaccines right now. There are a few coming. Flu-COVID combo, we are working on it, working as well on an RSV plus HMPV combination vaccines, that the HMPV component would double the impact of the RSV component, that could be a great innovation. There's some room for combination vaccines. What combination vaccines do is they bring convenience and coverage rate. What they do not do is compensate for gaps in any of the components.
You want to combine only the best-in-class components. You can't put a subpar component in the combination vaccines because that won't work. If you look at flu and COVID, you need to have a flu component that is proven, that has what we call protection beyond flu, hospitalization data, multiple season, multiple strains. You need to have a great reactogenicity profile. If not, you're going to lose patients. You need to have a formulation that enables to be fridge stable, prefill syringe and work. These are three very important criteria. After that, you can start to discuss combination vaccines. There is room for combination vaccines in adults, for sure, as a complement to standalone, that are going to stay for quite a while as well. That's the combo piece to your question.
Now, on the schedule, I would say that for pediatric schedule, it's relatively easy. You get Beyfortus at birth or a few days or weeks after birth. Flu is six months after birth. You can get COVID as well for a stated population. It's relatively clarified and easy for providers. They know what they have to do. For adults, it's a bit more complex because the schedule is not as firm yet. It's being firmed up, at some point. I think as well, here it's relatively simple for providers. They know that when autumn comes, September, October, they have to do flu, they have to do COVID. They might do RSV. They can do it every three-five years, they don't have to do it in September. Out of season, they can do hep B for adults, they can do shingles, they can do PCV.
Somehow there is room for immunization all over the year, and providers like that because it means steady business for them. I think we have good clarity. Patients know what they need. Providers know what they have to do. Combo will help, but it's just one more brick to the immunization wall that is getting stronger and stronger for the future.
Very clear. Thank you. Back to immunology. Can we talk about learnings maybe over the last 12 months or so? I'm not sure there has been a radical change in launch performances, payer access, pricing, if I look at big launches in immunologic settings. Just your interpretation of has something changed? Does the political MFN overlay matter? Is there any dynamic that is different as I think about 2026 into 2027 versus maybe 2023 into 2024?
Absolutely. Most of our launches have been within the alliance, as you know, with DUPIXENT, our lead asset. By God, we are in the midst of a truly transformative time. I can pick three things, right? MFN for sure, the way LLMs are coming into play. 50% of US physicians now consult OpenEvidence before they prescribe a medicine. A whole model of data dissemination we have to rethink. Of course, we have to go through traditional congresses and conferences, but if they are relying on these Large Language Models, how do we adapt our data dissemination plans, et cetera? The PBM reform, and MFN, we are one of the companies that signed the agreement with the current government, and we really need to think through how that is going to play out, especially with the MFN eight countries announced.
Just those three things alone, as we have to really start planning, and we are. Today it might be OpenEvidence. Tomorrow it could be three different platforms. ChatGPT is already building their healthcare platform, so is Claude. How do we prepare for that? We are in the midst of that. Don't forget the patients. We study the patient journey so deep nowadays. We look at patient characteristics of a mild AD patient. What is their education level? What's their average household income? That will help us inform or that informs us where are they going for information. We are getting into that level of detail now, and we have to, it's not a choice anymore. Those three things alone, we have to rethink how we go to market with our future launches.
If I think about that from an Excel spreadsheet perspective, is that market expanding? Is that pricing pressure? Is that visibility is good for everybody? Where would you say we sit within that?
Yeah. It's all the above. The market expansion we hope, for example, in atopic dermatitis, even with all the number of mechanisms that's available, the advanced therapy penetration is still 20%. That means eight out of 10 patients who are actually eligible, their disease criteria or characteristic meets the requirement for an advanced therapy, are not on an advanced therapy. There's so much room to capture, and understanding that patient journey piece is absolutely critical. What is stopping the patient? Most people think it's just the prescription. It's not always the case. There are other things from a patient standpoint, when the physician recommends, "Hey, you're ready for advanced therapy," the patient is reluctant. Deep understanding of that will help us. That is the patient piece. As I mentioned, the physician piece, how are they consuming information?
Where are they getting their scientific? There's so much data coming out, and they can't be on top of everything, and they relied on congress attendance and all those things. Now LLMs are putting that data and ranking it for them at their fingertips, and how do we become part of that? The way the papers are written, the language has got to be different. You've got to tailor it for geo, the large language model. It shows up in the right language as well. You have to go into that level of detail. The MFN piece, obviously, that's from a pricing standpoint, how do we protect the value in the markets? Everything we do, it's about the patients and making sure when you bring innovative medicines, you need to make sure there's access for it as well.
How do we give optimal access in the right countries and right places, staying within the framework of MFN as well? All these things are going to have an interplay in the coming years.
Fantastic. Thank you. Back to Thomas. Can we talk about pneumococcal disease?
Of course.
Maybe just an update. Where are we on that? Kind of linking to what we talked about before, so the regulatory backdrop. Is it worth pursuing the way it was before? Yes or no? Where's the competition? I will ask you about Cidara later because I think people care, but let's do pneumococcal first.
Sure. Well, let's go to PCV. We have a PCV21 for pediatric, that's currently in phase III. As you know, we have actually seven studies ongoing. We're going to share that H2 2027. That product, if successful through phase III, will be a competitor to PCV20 today, which is the standard of care in pediatric. Let's see what the data bring. Let's see what role we can play. I think on PCV market, the market is evolving. I don't think there's going to be a winners take all in the future. It's been the case in the past because there was one option. Now there are more options. There will be more and more options for adults as well. That's where I think the commercial skills and capabilities will be essential. In pediatrics, for example, the portfolio you bring to customer is essential.
Customer don't want to buy from a zillion vaccines company. They want to get a trusted partner, do something deep on as many products as possible, and that's where we think we can play a part. We have VAXELIS, we have Beyfortus, we have the full primary series in our portfolio, which is a very strong asset with customers. Yes, there is competition. You've seen that two of our competitors at PCV program in pediatric that they postpone, and they go for higher valencies later, which gives us a bit more opportunity with our PCV21. We know Pfizer has accelerated their PCV25, which is fine. Again, it's going to be competitive market, and we have strong commercial capabilities.
That's the first coming wave in the next few years, and then there's going to be another wave potentially post 2030 with even more valences and we'll be part of that wave as well. We're very excited to enter this field. For us, it's on the upside.
Thank you. I wanted to touch on BD, and I'll start with immunology, and we could go on that on vaccines as well. I think it was you saying at some point that innovation doesn't happen in isolation. BD is clearly part of the game. Sanofi has that set up where there is the joint venture and you can't use the resources that are allocated to the JV for other assets. When you think about BD and assets coming into the mix, how do you think about that? What is it you're looking for?
For us, a lot of pharma companies do this. Everything we do starts with our therapeutic area strategy, and we update that every year. The first phase is right now, we start with the disease area strategy. A lot of companies make the mistake of looking at an asset going, "Oh, what can I address with this asset?" Whereas we start with a completely asset-agnostic view. We look at the disease area and go, "As a HCP, what are the things? What would be an optimal drug look like?" We ask patients the same question, "What is it that you need from this disease relief?" Then we rank them and look at it and go, "You know what? A disease modification or remission, that's a longer-term goal. We might not be able to address in the three years." We then classify those unmet needs.
We bring in our assets and say, "Okay, what assets do we have to address the needs five years, 10 years, and 15 years?" Most of the 15 years prioritization, we give it to a research organization because the lead time is 10- 12 years. We start mapping out in the five to 10-year gap, that's your phase II study. Do we have a gap mechanistically to address that unmet need? If we have internal gap, we put that on the BD M&A prioritization. Over the last three years, we really fine-tuned this under Paul's leadership. Before we get to JPMorgan, we've already ranked, mapped out the companies by our unmet need or our understanding of the disease unmet need, and based on which phase. We work with our BD team. To your point about Excel spreadsheet, we have a full Excel spreadsheet.
When I walk into a meeting, I know exactly where that asset would fit into my gap in our portfolio. That's how exactly. We don't think about alliance, X alliance at that point in time because we are purely following the science. We think immunology, our leadership in immunology as a totality, we can decide whether it goes to a partner, do we partner with a partner in the alliance, or do we take it on our own? Those decisions we make much later. Everything we do starts with the disease area strategy, then we build it into our therapeutic area strategy.
Got it. You can bring that spreadsheet to the Jefferies London conference. Just a follow-up to that. Just say hypothetically, if there's an asset that doesn't compete with DUPIXENT, so could in theory go into the joint venture and be synergistic from a therapeutic broadening perspective, but equally could fit into the organization because it's not competing with the joint venture, so it could fit with Sanofi outside of the JV. How is that decision made?
Without going into too much detail, there's always we want to maximize our partnership and the alliance, and there is a joint steer co within the alliance that these discussions takes place. As I mentioned, I was part of the alliance, then moved out to head up the non-alliance, the whole Sanofi pipeline. That discussion happens at the JC level, and those determinations are made after. Initially, it's all about the science and can we have a differentiated mechanism. That's our number one criteria. We have the discussions later on between where's the best fit for that asset. To your point, is it competing? Could it synergize with the existing infrastructure? Do we have all those things come into play afterwards and then we make the determination.
Got it. Thank you. Then Thomas, slightly different question on BD to you. Obviously there is sort of uncertainty in what's happening in the U.S. We talked about regulatory backdrop, the public perception. Is that helpful from a BD perspective? Are there deals you can do now because assets might be, I don't know, cheaper, more readily available because the regulatory uncertainty is there, or is that not the way to think about it?
Yeah. It doesn't really impact because it's right here, right now, there is this uncertainty, but over time, we're convinced that we're going to come back to something more normalized. Hopefully we start to see it. We'll see what comes in the next few months and quarters, but BD time and development time is a long time, as you know. I think we take into account, but it doesn't change decision-making now. The one thing I'll share on BD is, look, I've been 13 years in vaccines at Sanofi. I can tell you the last five years we've done so many more deals and moves than ever before, and it's playing out well if you look at our pipeline. We made the move with Translate Bio in mRNA. Now five years in the race, we have very promising data on mRNA.
We are where we wanted to be five years ago. You see the deal we did with Novavax. We now have NUVAXOVID in the bag. The deal with Vicebio, we now have another candidate for RSV + HMPV we talked about before. The deal with Dynavax, we just closed in Feb, going very well. I like this because it shows the investment we're making for the long term in vaccines. I like to see other players coming to the fun. I think it shows that you must be doing something right there. I think it's very exciting for the mid, long term.
Got it. Okay, we've got about two and a half minutes. Thomas, I promised to ask about Cidara. I've heard you talk about it before, obviously that's something that people wonder what does it do to the flu market?
Yeah
Sort of quick view on what does it mean.
No, look, it's a great move for Merck. Let's see where it goes. It's not competing with flu at all because it's a very specific population at risk. It's two to three doses. It's not given in the retail settings, given a very specific setting. If anything, it's positive because it's one more player to sing the song of flu that needs to be sung these days because people need to know how bad that disease is, and I think we want to continue the effort there. I'm glad that there's one more company joining that work, and I think it's a good complement.
Got it. That was very quick. Thank you. All right, last question for each of you. What do you think, maybe starting with Immunology, what do you think investors should listen out for over the next two to three quarters that will give them an idea whether the strategy is working? Obviously, there have been changes at Sanofi, what would you point people to, like, look, there's stuff in play that is actually working.
Yeah. Circle back to the phase III starts I mentioned, right? We have some, specifically as you asked, this next two quarters and maybe early next year. The data readouts on lunsekimig, CRSwNP and asthma will be presented second half of this year. We have ESTUARY data readout from amlitelimab on the durability of the mechanism. That's coming up. In the early part of next year, we have the RHS data. We have two mechanisms, as I mentioned, we have disclosed, and potentially maybe some LCM on duvakitug also, at TL1A. Those in the next three to four quarters, those are the things to watch out for.
Fantastic. Same question to Thomas.
Sure. Look, I'd be looking at how we deliver the performance Q3, Q4. It's always a big time for us in vaccines with flu, COVID, others. I think we guided for slightly decreasing sales in 2026. Let's deliver this year. Let's look at our strategy on protection beyond flu works out. Look as well at the integration of Dynavax. It's a big priority. It's going well. I think let's see this year. We're going to have some data on their shingles candidate, our shingle candidate, end of the year in 70 plus, just one more data point. Let's see what happens with PCV. It's H2 2027, but it could be an interesting addition to the portfolio as we shared.
Generally, you're going to hopefully observe how resilient vaccines are, how we're going to navigate the next few quarters, and how we build value for the mid, long term, which I'm convinced we are doing and will continue to do at Sanofi Vaccines.
Fantastic. Perfectly on time. Aayam, Thomas, thank you so much.
Thanks, Michael.
Thank you.