Sanofi (SNY) Earnings Call Transcript & Summary

My pleasure to kick off the next session. It's Sachin Jain here from European team at Bank of America. My pleasure to be hosting Paul Hudson, CEO of Sanofi, we have 40 minutes. I think, Paul, perhaps some interim commentary and then we'll get into Q&A. So with that, over to you.

So it's been an interesting year for me and for us. And while we've advanced the pipeline quite significantly. The only thing that's really irritating me was the itepekimab readout with 1 positive from 1 negative putting us in a complicated situation, we can get into that, just come from the EADV, very excited about brivekimig or bispecific NHS, the amlitelimab feedback was extraordinary, and we can get into that. It's -- I know that people accused me of being optimistic, but I do enjoy immunology marketplaces, share some of the insights, I picked up, if you like it. It was great for us. Tolebrutinib extension of PDUFA, I would rather they took longer to look at the data then made a decision with less data. So we will see how that plays out. Specifically, they will look at the GEMINI 1 and 2 data, which is good for us because you know the underlying disease, disability progression, impact with tole was almost as good as the secondary progressive population. We will see not in the FDA, but I'd rather it took longer and got to right conclusion. We're excited about where that will go post approval. The underlying performance is strong we're growing fast. We're trying to be more efficient. We could have been a bit clear at Q2 on an increase in leverage P&L, I decided that we had a debrief afterwards. I think we were not -- we haven't earned the right yet to be not specific with precision about how the P&L will evolve. We keep thinking we're there, we weren't there. So we took the hit. We'll be more precise at Q3 on how the year is going to finish and how we'll approach 2026. So feeling very good about the business, how we're operating. A lot of open questions about the U.S. administration and me as incoming Chair, replacing Albert in January. And what it means, and will there be anything left. So we will see how the plays out, happy to take questions on that. But it's been a bumpy year externally than internally for the company. We've got to just keep getting our work done, and we'll have to wait a bit longer to show you some proof points but it's part of the job.

Perfect. So I'll touch on all of those topics, actually. So if we kick off with the U.S. policy, we're expecting alleged leasing responses from yourselves and the peers by the end of this week. Should we expect responses or is this going to be, he said, she said and we'll fight it out and we'll see?

Well, I think we really -- I don't think -- we're all -- I think it's Monday, we're expected to respond I can't comment on other companies or us. But we are -- we took the letter very seriously. We did our analysis. I think all companies perhaps did the same. We have to decide what to do. However, the letter was not a legally binding set of orders nor executive orders aren't equally. So we understand where the government trying to go. We've had the dialogue that I think all companies have had with the administration independently. I don't see a clear path with how the requirements in the letter and how that can be delivered for the benefit of patients, for the benefit of equalizing prices and MFN. I don't see it myself. I think there has to be another way. We will find out who and how people respond next week. But I still think we are -- there's a danger of trying to address MFN and get the administration comfortable, but leaving up in the air, 232, IRA, tariffs, and I would hate to be in a situation where we think we've concluded MFN and then the tariff lever is waived in our face again, and here we go again, I think you have to try and bring a lot of things to a conclusion, which I know is very difficult for the administration, not the path to get a big win that's very public, they can be vocal about. So I don't know where that will play out. But I prefer to bring everything together. And I also think there should be some asks from the industry, which I know is not something said much, but I think the PBMs are not been included in this conversation. And I think the runaway train of 340B needs addressing. In my world, I would like to see a real price conversation take place, particularly for government patients and including that dialogue, some reflection on the role of the PBM, perhaps some type of transparency or capping or removing of duplicate discounts in 340B and a long-term view on the tariff placeholder of 15%. I don't know where we'll end up. We'll know more next week. It's -- one of the scenarios is that nobody responds, I don't know if that's real or not. And if that's the case, I'm sure the President will have some strong views on that. But we have time and as always with these things, many industries are event driven. So we'll see where everybody gets to by Monday.

Is it the base case expect nobody to respond because you didn't respond last time around. And so it's sort of we see you -- we don't know, you can do anything until legislation passes, so we're not going to give you anything. Is that sort of the attitude the industry is adopting?

Well, I think there's -- I think we could -- that people could take that approach. Again, there's nothing legally binding. But I think the President, whether you like the politics or not, is quite sophisticated in trying to get everybody off balance, trying to tip everybody into a voluntary response, which means he gets a quick win. And that may indeed be how it goes. I read, and I don't know, I didn't speak to Chris, but I read yesterday that, BMS will not launch drugs in the U.K. or wondering in particular, there is -- it will be the same price as the U.S., I think I read. So I only read it like you may have done, I haven't got any inside track. Those things are starting to happen. I don't know where it will play out or whether that's the thing the President is looking for. I think if the President doesn't feel he's got what he wants, he'll react in a certain way. And as most of us are now students of his deal-making approaches, it can be like this, and it can be unsettling for a period of time. but the win -- he will want a big win. I think personally, as incoming chair, we can get a big win for the President, but just not in the format as being requested. That's just my view.

I'll take one more question on this and we'll move on as we spend the entire 40 minutes. So I would say, this is my perception. Your commentary has been at the more cautious end of that last letter versus the other corporates on the 2Q calls, general message was, well MFN Medicaid, that's already in line. MFN pricing, DTC a couple of companies try it, doesn't really achieve anything that gives him the win and the new products launching, where we just weren't launching in the ex U.S. territory. So like why isn't this straightforward? Now I'm being super simplistic but apologies.

I understand it. Look, I joined health care to be in health care, I didn't join health care to decide not to bring innovation to European patients. That just seems like what -- however mercenary you all are, that just seems terrible. So I think we have to -- I'm in health care, and I fight for access all over the world. I don't choose to drop Europe just because my business is weighted to the U.S. It's not about Europe even. It's just about patients with unmet need, there is something morally and ethically responsible. I'm not saying we get it done. I'm just saying that I just -- I find it would be difficult for me to be in that camp. I think there's other ways. Maybe I get forced there. I don't know. I just think there's other ways of doing it. I'm not sure the fundamentals of how much prices are of properly understood yet. You know some of this data, but what they pay for government patients in the U.S., and I'll take the liberty of removing oncology for a moment because it's a protected class are between 20% and 40% more than what governments pay in Europe. That's like-for-like. That's like-for-like. It's not 4 and 5x. That's commercial patients. That's where the delta is. That's why I think PBMs should be involved. And I'm not saying it's easy. We're saying that's where it is. I'm happy to be seen as overly cautious. Thomas will be proud of me for the first time in a long time. I think nobody really knows what's going to happen. I think, after next week, we will know a bit more from the response, how we're feeling whether some companies chose different routes. I think it'd be a bit too casual of me to declare where I think it's going right now. I'm in health care for the right reasons. I do think there's a path to get it done and run an increasingly profitable business. It's not philanthropy, but I don't think we should just walk away from markets because we couldn't have the guts to get a deal done. But maybe I'm proven wrong.

Okay. Let's make Thomas a little bit more uncomfortable then. So what does the precision for 2026 mean in your mind?

You have to tune in Q3. We won't give '26 guidance until the beginning of '26, right? But I think what we reflected on because of the setback of itepekimab and I think it's just not high-quality thinking on how people have perceived amlitelimab. I think the questions move to, can you just make sure you get the P&L done over the science. And I think I misjudged that a little. I think I was still in the -- I didn't have any data is great. So it's hard for me to be disconnected from an unknown. I know immunology marketplaces. But -- so I think what we need to do at Q3 is to just say, look, these are the -- this is how we're going to get this year done. These are the moving parts for next year. And this is the type of approach you should expect from us. But for numbers, you'll have to wait until the beginning of next year.

So I'll take a couple of follow-ons. Where have you fallen out on R&D spend? So you obviously had the increase. I think there's been debate as to rate of increasing forward. Was it any cost line that you didn't really specify in the 2Q call, you're pretty clear on gross margin, pretty clear on G&A. Does that commentary still stand? And where do you stand in R&D?

It also sounds R&D will go up a little bit. The blend will be a bit different. Now we have more data. I think -- well, you know, but other people forget that as the time advances, good or bad, and our data matures, we can make better decisions because we -- I want to kick off all of our immunology drugs with this wider LCM strategy as possible. Now as the data matures, we get a chance to prune some LCM and know where our high-value indications will be and move that back to a 1, 2 indication play from 3, 4 because perhaps other people's efficacy has told us we don't need to be there or our own data. So there'll be some pruning just normal course of business and some reallocating as other data emerges from other areas that we think is exciting. That's fine. I think we have an internal objective on G&A and outside of the S of G&A, that it will be quite a demanding year, '26 for our organization. I won't declare which direction, but it will be high expectations of managing that. I think we deserve the S. I think our growth rate of high single digit didn't come by stumbling over it. We deployed it well for growth. We're one of the fastest-growing big pharmas, and we're pleased with that, and it's come in the launches. It's come in perfect execution. Dupixent in Q3, and you've seen the Ns and the Ts, you know it's growing faster than it has done in recent years in volume. That's incredible. That's amazing execution. So I think we're right on it, deploying S extraordinarily well, and we will invest to keep that growth rate high. We were on a drumbeat as a leadership team of top line pipeline, top line pipeline. And I think we felt that if we could get those delivered, the multiple would move with it, but stumble and a perceived stumble in R&D meant we have to go back and spend 6, 12 months, justifying our investments, we will do it because we know where we're heading. But it just looks like it was a big goal after Q2.

And my last question on the margin. So the moving parts...

And Amvuttra, we didn't -- maybe, you're going to get to that. But when I joined the company way about when and I was excited about fitusiran, Qfitlia and we had an opportunity because we have reciprocal royalties on Amvuttra and to try and harmonize it, and we decided just to leave it as it is both sides. Now the Amvuttra consensus is climbing continuously, and we have 30% over EUR 1.5 billion. And they have a follow-on. I'm not sure of the profile, I'm not in that area. I know 0 about that area. But I would imagine that the other income from Amvuttra will be around for quite a number of years, perhaps longer than forecast. We get that as the development balance for Dupi goes the other way. We've managed G&A. We're moving towards specialty care blend on our portfolio. So I think the leveraging of the P&L is moving in exactly in the right direction. And that didn't change for us. I just felt we were too loose with the narrative around Q2.

So it's going to be very specific. So a lot of the comments you've given there, all of those moving parts are 2Q, but where investors ended up focusing with the 2 or 3 questions around is margins up, down, flat next year, which CFO understandably at 2Q didn't want to answer. But when we put all these parts together, it seems to me that margin should be getting up this year. Is that fair or not?

Well, you'll find out in next year. I mean, we -- I we won't share an up or down or flat. But Q3, we'll just tell you those levers in a little bit more context of why we think that our underlying P&L performance will continue in a way that shows that we're still accruing positive sentiment in R&D, and we need to get our job done. So I think you should expect that. What that looks like, you have to wait. I understand the importance of the question, but we try not to miss on any number. We're right on track for where we wanted to be this year. We're feeling good about how we're going to exit. As said Dupi is moving faster, ALTUVIIIO blockbuster. We're really -- the Blueprint acquisition has turned out to be at a 27% premium, absolutely phenomenal. So we have quite a few things that are moving in our favor for next year, but we'll wait for the details until we get into our Q4 results.

On to tole, if you could touch on how I read the FDA looking at the RMS data for Gemini as part of an SPMS?

Well, they said need a longer to look at the data. And we asked them, what do you need, they said they're also going to take another look at Gemini 1 and 2. It's not because of relapsing, the ARR was difficult to be Aubagio, everybody has been down that path, and they're going to have to redefine a MS. The regulator is going to have to move the endpoint because innovation will start. We think frexa can blow through but I mean for the rest of the treatment has been very difficult. But you'll remember, we also captured the delay in disability progression in Gemini 1 and 2. And the data was extraordinary that's sort of closer to the PIRA population as being one of the newer definitions of MS. The progression independent of relapse that's in that sweet spot. I think the regulator is saying we may as well took it a wider data set in a patient population that's very close to the second reprogressive population, but not identical. Because why not? So it's a choice to make. I would rather just spend longer looking at the data, like I said earlier than not.

So tilting between efficacy, safety, patient population? Is it, again, just inferring, is it more patient population definition because there's nonetheless being SPMS is a new population for obviously indication. You sort of referenced the overlap with RMS, this is a continuum, so is that what the FDA is focused on?

I think as part of their job is to tell me who's the treatable population in the label, yes, so I think they'll take as much as time as they need. On the risk benefit profile tole has had a bumpy ride, but it's still there because it's just something that no other treatment does, is unmet need, no drugs approved. We know after we adjusted the protocol to a weekly blood draw for 90 days and then every 6 or 12 months meant that there was no new safety risk, so you could just enjoy the benefit of the efficacy we demonstrated that after we changed the protocol in the Phase III in the U.S. And so we want them to take a look at all of the data. We'll get PERSEUS end of the year. And that will be interesting data, but it's a very different population to -- in primary progressive to secondary progressive, there's many years between those 2. So I don't know exactly what they're trying to find. But I think we had 940 patients in GEMINI 1 and 2 that have safety and efficacy data, which may help them characterize who's best in secondary progressive. If I wanted to be optimistic, which I have been on occasion, I would say, oh, that's great. That might take us into a broader population. But I don't think that's our intent. I think their intent is solely to help us confirm who a secondary progressive patient is and attached the right safety and tolerability -- sorry, safety and efficacy profile to that.

How late in the cycle was the GEMINI data submitted?

I don't think we've shared that.

Is there any specific focus from them on the REMS? Or is it more focus on...

Well, it's been clear through the mid- and late-cycle reviews, the REMS was going to be important. And I was just saying to the group earlier, I was in the U.S. with our tolebrutinib team last week, and I said REMS is your objective. This, if we're approved in secondary progressive, and we're the only drug and likely to be the only drug, and I'm still not aware of anybody else trying to research in secondary progressive. So preserving the profile of this medicine at the premium end in the most difficult-to-treat patients, of which we think there's about 30% of the total whatever the REMS is given to us. We like what we did in the study and it supported that it was the right and safe thing to do. If it's that or some variation of that, our focus is to make that absolutely perfect. Absolutely perfect. I was asked earlier, is there a bolus of patients. There was absolutely a bolus, but perfect execution of REMS means that I'd rather take a slower uptake and a much bigger peak because of confidence of physicians must not compromise REMS, I've been around MS a long time. And as soon as somebody got a PML or something, everybody got twitchy, the peak softened and all of this. We just got to do this the right way, slow and steady. We did that. We've done a few good deals, I think, Blueprint, of course. But the Principia deal was -- we've just launched rilzabrutinib in ITP. We have waHA and other indications to come. We'll go into sickle cell. We may even go broader into other autoimmune diseases and tole comes out of the same stable. So we'd like to think we'll get both of those BTKs over the line. And there will be tremendous value for patients and frankly, because we're a business, it will help us grow the top line.

To amli, obviously, sound like a group upstairs, but I want to -- perhaps to kick off is how you're thinking about peak sales in the scenario of cost that sure was an interesting perspective.

Yes. Well, I just went to EADV. I met north of 20 dermatologists who are -- were excited more than a lot of our friends. This is a big deal. I spent quite a bit of time at the end of '23 in the slide deck on just using psoriasis as an analog to show how all boats rise in immunology, I had campaign this tirelessly because the data supports it. I don't find many people listening to it, but I find it's still important to do because it's an education on the future of autoimmune diseases and exactly what will happen. We said at the time, you get a standard of care, in this case to be a great drug, perhaps even better than HUMIRA was going to psoriasis, you get more selective you get new MOAs, you get longer interval and you get to an oral. That's how every autoimmune disease plays out, some stage of continuum. And penetration rises, rises, rises. It's only 2 years since I was here and people said, is Dupi finish lebri is launching. We said, no, actually, Dupi will grow faster when lebri launches because biologic penetration will go up. That's exactly what happened. It's exactly what happened. And as I said, Dupi and volume is growing faster than it's ever grown off a much higher base. And that's very important for you to understand the world that amli will launch into COAST 1 data was in many ways better than we expected. We did not expect at all an outright win on 212. We were absolutely thrilled to get that because we know interval is one of the main drivers of penetration in biologic marketplaces, perhaps rank 2 after selectivity. So we know that is a major win for us. It was unexpected. We knew that we were struggling, many of you told me that we would at 24 weeks, it was too soon for a drug with a slower onset. So we -- I would have liked to hire effect size because it would have kept everybody happy, but it wouldn't change the profile of the medicine just because we know that the efficacy accumulates. We'll get COAST 2 in the new year, early on. And if it's the same as COAST 1, I believe we'll be a EUR 3-plus billion drug in AD. If we get really lucky and ESTUARY shows us the increasing efficacy. This is by next summer, that it continues and it closes the gap on the effect size. It doesn't have to get all the way because the interval is important, then we're a 5-plus drug. Safety got to be maintained, what we saw in COAST 1 made us feel good about that, COAST 2, please reproduce it. We may take a look at ATLANTIS or open-label extension in early '26 which has patients that are out beyond a year just to help with the narrative and to provide some more data, but the randomized control ESTUARY will be the next piece. And then we'll present TIDE, the data on Asthma of ERS, I think, Sunday -- on the Sunday. Very interesting for us on that. We got dinged for that earlier on in the year. But I think what's really important is where it will be in a -- I won't go into the details now, but in a significant subgroup where we could have best in disease efficacy and exacerbation reduction. And so that may surprise people. And so it's building exactly as we thought it would be. And I was pissed with the market reaction, but it didn't change anything with us, with the OCEANA program, how it's been put together, what it will inform, why this drug will be big. We built that program to take advantage of everything we've learned from 25 years of biologics. And that -- and so I came away irritated that it was just going to take longer to show it because it's always nice to get, but so be it. Nothing changes for us. We talked earlier, I ran about 10% of patients with -- in the biologic naive in AD are highly inflamed, very symptomatic. I would imagine Dupi is -- if Dupi is going to grow until the end. I want that to be on record as Len comes hunting me down. But there is a group that will need immediate impact, and it might be with a JAK, it might be with steroids, it might be, whatever. But about 90% of patients in the moderate to severe group will be offered a 12 weekly injection of a new mechanism with a chance of drug-free remission a year or 2 later. That's a game-changing offer. Of course, as a new MOA, you get second line. But I needed to be reassured, and that's what I got out of the ADV, the number of physicians are, no, no, no. This will be first line. This is how we see the market moving around. I like that. And then make sure we get the data to show that it can be done. And that's the next big thing.

Can I pick a few things. So ESTUARY, just to make sure we get it right, what's the time frame for the endpoint? And what are you hoping to get to by then to sort of confirm the greater than EUR 5 billion.

The endpoint is 52 weeks, I think, in ESTUARY, you have to correct me. It was -- it's more -- we get a look at what happens to this progressive efficacy build beyond 24 weeks. That's all that's interesting. We know because we spend a lot of time on nemo and looking at -- I was showing the group earlier that nemo does very well because it hits it very quickly, but it doesn't really treat AD, which is why 40% of patients at 6 months have dropped out. They drop out because of the lack of efficacy or because they've made disease worse. And getting over itch is a big deal, but it's not enough on its own. We know from our own data that between weeks 4 and 5, you get a positive impact on itch with amlitelimab, which is great because the patient wants to know, is this working for me? That's sort of necessary. That's sort of necessary. And then we moved the chance of drug-free remission eventually, and the patient pool is so big, we can be even bigger than I expect. If the profile holds together, I had many profile that's just fallen apart sadly at the last moment, so I become a little bit wiser, but OCEANA was absolutely developed to go and get an outright win in AD and potentially asthma, and we're still on track to do that.

Last question. What's your sort of anecdotal doc feedback of what percentage of frontline this would get and what type of patient? And then similar question for second line versus the JAKs?

Well, I think the JAKs are doing well and as said it all along, we like the idea of orals prebiologic. We like that, not because they cannibalize, but because they pull moderate to mild to moderate just a little bit further forward. The pool gets significantly bigger. And I think they've done a good job. It's one of the reasons why we pursued oral TNF because we'd like to be in that space, but with a better safety profile. And if the RA data has been with oral TNF by the way, then I think- and we're doing very good. I'd like to see a positive efficacy at ACR 50 and 70. That's where the action is. That's the prebiologic action. That's where we got to go, we'll get that data soon and we'll know whether it can go mono or he has to go combo, we'll find out. For amli, when a physician is -- and remember, penetration of biologics in AD is 15% of the 100. So 85% of patients who should be on a biologic are not on a biologic. Lots of reasons for that. But I think what's going to happen is, physicians are going to look and say, Dupixent is tried, tested, it's got great efficacy, it's got great safety, it's well understood. It's every couple of weeks. Now you have an every 12-week play with a slightly slower onset but the chance of drug-free remission, that was a surprise for me, by the way, from EADV, the amount of people understood what the eventual payoff may be. But I have to accept that you don't get the highly inflamed patient upfront, so you lose the 10%, you're left with the 90%, you're now bifurcating by interval, which is often the case. Not everybody wants injections. Sadly, but that's how that goes. And interval is one in all the other biologic marketplaces. You see it, the data is there. As long as you haven't traded too much on efficacy. And then this chance of drug-free remission is -- had captured people's imagination more than I expected. What that looks like, maybe that's just a dream and it means they get initiated, I'm happy with that. So I would expect us to do very, very well. I won't give a percentage but very well in new patients and to do well by default, not because we're any good as a team, but just because of after the cytokine approach people will want to move to 40 ligand. It's exciting. It's really exciting.

Oral TNF, should we expect that with a 3Q release?

I don't know. I'm looking at Thomas for any incentive visible. Potentially, okay, potentially.

I'll just take a real big picture question now for me. So one of the debates for 3 or 4 years, Sanofi, it's been a fresh start for you it was delivering the financials, lots of good stuff going on in R&D, but the last year, the market has viewed it as a step back. So it's again, really big picture, you've been at CMD a couple of years ago, you framed the big assets you talked about. So just what do you remain excited to buy on a 2 to 3-year view in the pipeline as a big wins that will play through?

Yes. Well, it's -- as I was saying to some people that the only thing that's annoyed me this year is itepekimab. And it was not that it annoyed me, it annoyed me because we had a win or a loss. We just made a complicated choice, about what we do next. The Roche data was underwhelming. So one competitors disappeared. I think AZ is in all comers in COPD. If that's the case, they'll probably get the same result, and they just fail with FASENRA. So do we really want to do another Phase III, it's 3-plus years, but we might be the only game in town. And we still have the DP infrastructure and rebate to leverage. So it's a little later in the game than I would like, but maybe it's still valid. So we'll got ERS, see what Roche share. We'll get the bronchiectasis data because that could be a blockbuster indication on its own. If that's good, and we learned something from ERS and from our own analysis, we may push and do the other Phase III. That's a joint decision between us and Regeneron, we haven't done that. The rest of it, I was very pleased to hear, the amli data for us is right where it needs to be, so the interval upside was phenomenal. We just didn't expect to -- and we've moved along very nicely with the launches and the rest of the pipeline. Brivekimig data, we didn't get much coverage, which on paper at this in Phase II is better than BIMZELX, that's another option with a different mechanism. So that's going to do very well. Oral TNF will find out, I'd like that to be still there, rilzabrutinib is launched. We're just running through the big 12s. I think -- the industry has taken a hit this year in general. It used to be a safe place. It feels less safe. Again, this is more your world than mine. And we were seen as safe and boring and I think once we took more R&D on, people started to get a bit bipolar on what they felt. And we knew it would be bumpy. I didn't think this year as we've advanced the pipeline is as bumpy as it's being interpreted, but I understand that people can decide whatever they like. I just got to keep turning the cards over, accumulate the wins. I feel better about the year than others, except it's effect. E.Coli was a shot with J&J literally pumping the pump to other go at sepsis, and we should always take those, always take those. Frexa, next up, we're very happy with another year in the development journey is passing Bio, Frexa, we get closer to goal. Duvakitug with Teva, the TL1A another year has moved along the continuum. So we get closer to readouts. While it's been painful, the sort of -- we just march along trying to get to the toll gate. So I think that's quite nice. But I'm humbled by the reaction from the market when we get the data. It shows you how finely balanced we are. The company is 53 years old. It's never been famous for doing R&D. We could have stayed as we were as a dividend play and just put more reps on Lantus. We made a decision that there was -- we made a decision that -- maybe Plavix in China. And we decided that the company -- we owed the company a chance to break out from that. There's many things I've got wrong in this job, many things. I didn't describe how painful the journey would be at the beginning. I looked at Lilly and AZ and it was a 5- to 7-year R&D turnarounds. And I remember thinking at the time, we'll do better than that. I was completely wrong. Completely wrong. And I have huge respect for Dave and Pascale, I was completely wrong. And I should have signed upfront, that's exactly how long it's going to be. We didn't do any faster. It will be next year before people say, you know what, you can do a bit of R&D. I just thought we'd be faster. We weren't. That's on me, and I've led the organization with that drumbeat. So I take it on the chin. And I'm -- I think Lunsekimig, frexa, duvakitug, amlitelimab, we are right where we need to be and we're a little -- we're a year down the development journey, which while people think how do you cope with all those challenges, et cetera, I cope because when I reflect, we're a year down that journey, I can't make time pass by faster. So we're accumulating that. So we're happier inside than you guys are outside, but we know we still have some work to do.

DP LOE extension beyond '31. You sort of toy with the idea of potentially extending it or communicating just on market?

You guys get it. I think that's one of the reasons we got such a negative on amli, by the way, I think because we believe that it will play a big part in our life after Dupi. But I think because of the effect size, we got a disproportionate hit based on the replacement power of Dupi. We have all these drugs in play, which, let's say, 50% don't make it and 50% become $2 billion, $3 billion, $4 billion drug. So at this stage, we can put that number around and we may get positive or surprised. That's good enough for us to do what we need to do to be able to grow EPS through Dupi. But the reality is we have to earn the right to show that. The rest of the plans on Dupi and managing the end of exclusivity. We don't share and we won't share. It would be easier for me to tell you exactly what we're going to do and then everybody goes, oh, that's interesting. That's a bit more positive. I don't know whether you think that, I would like to think so. It's not in mind of the company's interest to show our hand with Sandoz, Teva. Even Teva, with people around who can move quickly to try and get a step ahead of us. So heads down get through the toll gates, launch the drugs with enough time for people to see that our run rate, of something of EUR 10 billion of new product sales by the end of the year -- sorry, by the end of the decade. And that's where we will be plus more wins. So we're in good shape. I hate waiting, I'm a very impatient person, but I'm learning to be better at that. So we'll see. We're in a good spot, and we'll have to prove ourselves. That's our job.

And we're on time. One question at the back, maybe? I should have taken earlier.

About vaccine, you have a partnership with Novavax. When do you think we'll get combine COVID and flu vaccine? And then on with Translate Bio, you made an acquisition several years ago, for EUR 3 billion. What are the main targets now with this new administration, please?

So we're passionate about the mRNA work. We went from 0. Remember, we did translate, I think Moderna was EUR 186 billion cap that week. We translate up for EUR 3 billion to get a slim shot on the mRNA piece. We wanted to make sure that if mRNA came something that we needed to participate in it. I think we've gone from nowhere to a season behind them on most of the mRNA programs, forgetting oncology. We understand this administration sensitivity to mRNA, works for us and against us. Our mRNA programs around acne, chlamydia, other things or after this administration. So we -- our timing was brilliant or lucky, let's take the last one. And so the Novavax deal, we knew Novavax was going to have the last approvable COVID vaccine, and it was non-mRNA. We got a very good deal on that. Nobody else wanted to be involved. We do the combination with high-dose flu. If we were really lucky, we'd be approved in '27, most likely '28. I think Moderna is at '27, but not with the flu efficacy that we'll have and their mRNA. I don't think there's anything wrong with their mRNA. We're in mRNA. But the sensitivities around that at this time and at that time, are still real for the administration and what's been happening. So again, luck or opportunity, I don't know, but a non-mRNA flu COVID without the reactogenicity we hope, delivered in '27 or '28 could be the premium end of the future for the over 55, 65s. It's great if we get there. I don't know, if we'll get there, but we got our mRNA. It's also later in the cycle of pipeline for us. and we've got the flu COVID. It was a good deal with some good deals, by the way, but that was another good one, and we'll see where that plays out.

Perfect. Well, I think we're on time. So Paul, thank you so much for your time.

Thank you.