My pleasure to kick off the next session. It's Sachin Jain here from the 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 intro commentary, and then we'll get into Q&A. With that, over to you.
Good. I'm in the right seat.
Wherever you want.
It's been an interesting year for me and for us. While we've advanced the pipeline quite significantly, the only thing that's really irritated me was the Itepekimab readout with one positive from one negative, putting us in a complicated situation. We can get into that. Just come from EADV, very excited about Brivekimig. I'll buy specific NHS. The amivantamab feedback was extraordinary, and we can get into that. I know that people accuse 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 than made a decision with less data. We will see how that plays out.
Specifically, they'll look at the GEMINI I and II data, which is good for us because, you know, the underlying disease, disability, progression impact with tolebrunitib was almost as good as the secondary progressive population. We'll see. I'm not in the FDA, but I'd rather they took longer and got the right conclusion. We're excited about where that will go, post-approval. You know, the underlying performance is strong. We're growing fast. We're trying to be more efficient. We could have been a bit more clear at Q2 on an increasingly leveraged P&L. I decided that, you know, we had a debrief afterwards. I think 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. We took the hit.
We'll be more precise at Q3 on how the year's going to finish and how we'll approach 2026. 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. We will see how that plays out. Happy to take questions on that. It's been a bumpier year externally than internally for the company. We've got to just keep getting our work done. We'll have to wait a bit longer to show you some proof points, but it's part of the job.
Perfect. I'll touch on all of those topics, actually. If we kick off with U.S. policy, we're expecting allegedly some responses from yourselves and the peers by the end of this week. Should we expect responses, or is this going to be a he said, she said, and we'll fight it out?
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. 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. Remember, the letter was not a legally binding set of orders, nor are executive orders equally. We understand where the government's 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.
I still think there's a danger of trying to address MFN and get the administration comfortable, but leaving up in the air 232, IRA, tariffs. I would hate to be in a situation where we think we've concluded MFN and then the tariff lever is waved in our face again. 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 it. I don't know where that will play out, but I prefer to bring everything together. I also think there should be some asks from the industry, which I know is not something said much, but I think the PBMs have not been included in this conversation. 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 include in 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 at 15%. I don't know where we'll end up. We'll know more next week. If one of the scenarios is that nobody responds, I don't know if that's real or not. If that's the case, I'm sure the president will have some strong views on that. We have time, and as always with these things, many industries are event-driven. We'll see where everybody gets to by Monday.
Is it the base case to expect nobody to respond? Because you didn't respond last time around. It's sort of this, we see you, we don't think you can do anything, you know, until legislation passes. We're not going to give you anything. Is that sort of the attitude the industry's adopting?
I think we could, that approach, 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 at trying to get everybody off balance, trying to tip everybody into a voluntary response, which means he gets a quick win. 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 one drug in particular unless it'll be the same price as the U.S., I think I read. 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's looking for.
I think if the president doesn't feel he's got what he wants, he'll react in a certain way. As most of us are now students of his deal-making approaches, you know, it can be like this and it can be unsettling for a period of time. 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 opinion.
I'll take one more question on this and we'll move on as we spend the entire 40 minutes. I would say this is my perception. Your commentary has been at the more cautious end of that last letter versus the other corporate on the two key calls. General message was, MFN Medicaid, that's already in line. MFN pricing, DTC, a couple of companies try it, doesn't really achieve anything, but gives him the win. Then new products launch and we just won't launch in the ex-U.S. territory. Like, why isn't this straightforward? I am being super simplistic.
I understand it. Look, I joined healthcare to be in healthcare. I didn't join healthcare to decide not to bring innovation to European patients. That just seems like, however mercenary you all are, that just seems terrible. I think we have to, you know, I'm in healthcare 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 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 from them 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 4x and 5x . That's commercial patients. That's where the delta is. That's why I think PBMs should be involved. I'm not saying it's easy. I'm just 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 am in healthcare 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. Maybe I'm proven wrong.
Let's make Thomas a little bit more uncomfortable then. What does precision for 2026 mean in your mind?
We have to tune in at Q3. You know, we won't give 2026 guidance till the beginning of 2026, right? 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 amivantamab. I think the questions move to, can you just make sure you get the P&L done over the science? I think I'd misjudged that a little. I think I was still in the, amivantamab data is great, so it's hard for me to be disconnected from it. I know immunology marketplaces, 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. For numbers, you'll have to wait till the beginning of next year.
Can I say a couple of follow-ons? Where have you fallen out on R&D spend? You obviously had the increase. I think there's been debates as to rate of increase going forward. It was any cost line that you didn't really specify in the Q3 call. You're pretty clear on gross margin. You're pretty clear on G&A. Does that commentary all still stand? Where do you sit on R&D?
It all still stands. R&D will go up a little bit. The blend will be a bit different. Now we have more data. I think people, 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, you know, I want to kick off all of our immunology drugs with as wide an 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 one-two indication play from three-four because perhaps other people's efficacy has told us we don't need to be there or our own data. 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 is, that's fine.
I think we have an internal objective on G&A and outside of the S of G&A that it'll be quite a demanding year, 2026 for our organization. I won't declare which direction, but it'll be high expectations of managing of 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. You know, we're one of the fastest growing big pharmas, and we're pleased with that. 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. 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.
There's 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. A stumble and a perceived stumble in R&D meant we have to go back and spend six, twelve months justifying our investments. We will do it because we know where we're heading. It just was like, it was a big gulper there after Q2.
Sure. My last question on the margin, the moving parts.
Oh, and Amvuttra. We didn't, maybe you're going to get to that. I was going to get to that. When I joined the company way back when, I was excited about Fatou, Saran and we had an opportunity because we have reciprocal royalties on Amvuttra and to try and harmonize it. We decided just to leave it as it is, both sides. Now the Amvuttra consensus is climbing continuously. We have 30% over $1.5 billion, and they have a follow-on. I'm not sure of the profile. I'm not in that area. I know zero about that area. I would imagine that the other income from Amvuttra will be around for quite a number of years, perhaps longer than it's 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. I think the leveraging of the P&L is moving in exactly the right direction. That didn't change for us. I just felt we were too loose with the narrative around it at Q2.
It is going to be very specific. A lot of the comments you're giving there, you gave all of those moving parts at 2Q, but where investors ended up focusing was the two or three questions around, is margins up, down, flat next year, which CFO understandably at 2Q didn't want to answer. Yeah, but when we put all these parts together, it seems to me that margins should be going up next year. Is that fair or not?
You will find out in the next year. I mean, we won't share an up or a down or a flat, but at Q3, we'll just tell you those levers and 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. I think you should expect that. What that looks like, you'll have to wait.
Very clear.
I understand the importance of the question, but you know, 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 I said, Dupixent is moving faster. Amvuttra, blockbuster, you know, we're really, the Blueprint acquisition has turned out to be at a 27% premium, you know, absolutely phenomenal. 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 the Q4 results.
Very clear. Onto tolebrutinib, if you could touch on how I read the FDA looking at the RRMS data for GEMINI as part of a secondary progressive multiple sclerosis.
You know, they said they needed longer to look at the data. We asked them what do you need. They said they're also going to take another look at GEMINI I and II. It is not because of relapsing remittance. The ARR was difficult to beat, a bad show. Everybody's been down that path and they're going to have to redefine MS or the regulator is going to have to move the endpoint because innovation will stop. We think FREXA can blow through, but for the rest of the treatment, it's been very difficult. You'll remember we also captured the delay in disability progression in GEMINI I and II , and the data was extraordinary. In fact, that's a bit closer to the Pyra population, as 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 look at a wider data set in a patient population that's very close to the secondary progressive population, but not identical, because why not. It is the choice to make. I would rather they spend longer looking at data, like I said earlier, than not.
Tilting between efficacy, safety, patient population, is it again just inferring, is it more patient population definition because there's non-RS being SPMS is a new population for obviously an indication? You've sort of referenced the overlap with RMS and this is a continuum. 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. Yeah, I think they'll take as much time as they need. On the risk-benefit profile, you know, Tole's had a bumpy ride, but it's still there because it's just something that no other treatment does. 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. We want them to take a look at all of the data. We'll get PERSEUS, you know, end of the year.
That will be interesting data, but that's a very different population in primary progressive to secondary progressive. There are many years between those two. I don't know exactly what they're trying to find, but I think we had 940 patients in GEMINI I and II 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. I don't think that's their intent. I think their intent is solely to help us confirm who a secondary progressive patient is and attach 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 focused on this other thing?
It has been clear through the mid and late cycle reviews that REMS was going to be important. I was just saying to a group earlier, I was in the U.S. with our tolebrutinib team last week. I said, REMS is your objective. If we're approved in secondary progressive, and we're the only drug and likely to be the only drug, I'm still not aware of anybody else trying to research in secondary progressive. 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 in her case, and it's 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 is 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 a 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, you know, 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. The Principia deal was, we've just launched rilzabrutinib in ITP. We have Weihau and other indications to come. We'll go into sickle cell. We may even go broader into other autoimmune diseases. Tole comes out of the same stable. We like to think we'll get both of those BTKs over the line. They'll bring tremendous value for patients. Frankly, because we're a business, it will help us grow the top line.
Very true. Onto Amelior. I'm obviously starting that group upstairs, but one of the interesting, perhaps to kick off, is how you're thinking about peak sales in the story of Coast and Asher. I thought that was an interesting perspective.
Yeah, I just went to EADV. I met with 20 dermatologists who are way excited, more than a lot of our friends. This is a big deal. I spent quite a bit of time at the end of 2023 in the slide deck on using psoriasis as an analog to show how all boats rise in immunology. I campaigned this tirelessly because the data supports it. I don't find many people listen 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, Dupi, great drug, perhaps even better than Humira was going into 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 at some stage of the continuum, and penetration rises, rises, rises. It's only two years since I was here and people said, is Dupi finished? Lebri's launching. I said, no, actually, Dupixent will grow faster when Lebri launches because biologic penetration will go up. It's exactly what happened. It's exactly what happened. As I said, Dupit in volume is growing faster than it's ever grown off a much higher base. That's very important for you to understand the world that Amelior will launch into. Coast One data was in many ways better than we expected. We did not expect at all an outright win on Q12. We were absolutely thrilled to get that because we know interval is one of the main drivers of penetration in biologic marketplaces, perhaps ranked two after selectivity. 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 were at 24 weeks. It was too soon for a drug with a slower onset. I'd have liked a higher effect size because it would have kept everybody happy, but it wouldn't change the profile of the medicine. Just because, you know, we know that the efficacy accumulates. We'll get Coast Two in the new year early on, and if it's the same as Coast One, I believe we'll be a $3 billion+ drug in atopic dermatitis. 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 billion+ drug. Safety's got to be maintained.
What we saw in Coast One made us feel good about that. Coast Two, please reproduce it. We may take a look at Atlantis or open-label extension in early 2026, which has patients that are out beyond a year, just to help with the narrative and to provide some more data. The randomized control, ESTUARY , will be the next piece. We will present TIDE, the data in asthma at ERS, I think on Sunday. It's very interesting for us on that. You know, we got dinged for that earlier on in the year. I think what's really important is where it will be in a, we're not, I won't go into the details now, but in a significant subgroup where we could have best-in-disease efficacy and exacerbation reduction. That may surprise people. It's building exactly as we thought it would be.
I was pissed on 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. I came away irritated that it was just going to take longer to show it because, you know, it's always nicer to get, but so be it. Nothing changes for us. We talked earlier, I ran about 10% of patients with new biologic-naive in AD are highly inflamed, very symptomatic. I would imagine Dupixent is going to grow till the end. I want that to be on record as LEN comes hunting me down. 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.
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 two later. That's a game-changing offer. Of course, as a new MOA, you get second line. I needed to be reassured, and that's what I got out of EADV. The number of physicians like, oh no, no, this will be first line. This is how we see the market moving around. I like that. Make sure we get the data to show that it can be done. That's the next big thing.
Can I pick a few things? ESTUARY, just to make sure we get it right, what's the timeframe for the endpoint, and what are you hoping to get to by then to sort of confirm the greater than $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.
Okay.
We know, because we spend a lot of time on NEMO and looking at, and I was sharing with the group earlier that NEMO does very well because it hits itch very quickly, but it doesn't really treat AD , which is why 40% of patients at six months have dropped out. They drop out because of a lack of efficacy or because they've made disease worse. Getting over itch is a big deal, but it's not enough on its own. We know from our own data that between weeks four and five, you get a positive impact on itch with amivantamab, which is great because the patient wants to know, is this working for me? That's sort of necessary. That's sort of necessary. We move the chance of drug-free remission eventually. The patient pool is so big. We can be even bigger than I expect.
If the profile holds together, I've had many a profile that's just fallen apart, sadly, at the last moment. I've become a little bit wiser. OCEANA was absolutely developed to go and get an outright win in atopic dermatitis and potentially asthma. We're still on track to do that.
Last question. What's your sort of anecdotal doc feedback of what percentage of front line this would get and what type of patient? Then similar question for second line versus the JAKs.
I think the JAKs are doing well. You know, we've settled 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. 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. If the RA data is good with oral TNF, by the way, then I think we're doing good. I'd like to see, you know, 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 whether it has to go combo. We'll find out.
For Amelior, 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. 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 the surprise for me, by the way, from EADV, the amount of people that understood what the eventual payoff may be. I have to accept that you don't get the highly inflamed patient up front. 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. An interval is one in all the other biologic marketplaces. You see it, the data's there. As long as you haven't traded too much on efficacy. This chance of drug-free remission 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. I would expect us to do very, very well. I won't give you 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 toxically like and.
Very true.
It's exciting, it's really exciting. We'll see.
If you're on a TNF, should we expect that with a Q3 release?
I don't know. I'm looking at Thomas for any type of visible.
Potentially.
Okay, potentially.
I'll just take a real big picture question now for me. One of the debates for three or four years, sounds to be a little bit frustrating for you, is we deliver the financials, lots of good stuff going on in R&D, but the last year, the market has viewed it as a step back. Just again, really big picture, you know, CMD a couple of years ago, you framed the big assets you thought about. What do you remain excited by on a two to three of you in the pipeline as the big wins that will play through?
Yeah, as I was saying to some people, the only thing that's annoyed me this year is Itepekimab. It was not that it annoyed me. It annoyed me because we had a win and a loss. We just made a complicated choice about what we do next. The Roche data was underwhelming. One competitor's disappeared. I think AZ is in all comers and COPD. If that's the case, they'll probably get the same result. They just failed with FASENRA. Do we really want to do another phase III? It's three plus years, but we might be the only game in town. We still have the Dupi infrastructure and rebate to leverage. It's a little later in the game than I would like, but maybe it's still valid. We'll go to 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 learn something from ERS and from our analysis, we may push on 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 with the year. The Amelior data for us is right where it needs to be. The interval upside was phenomenal. We just didn't expect it. We moved along very nicely with the launches and the rest of the pipeline. Brivekimig data, which didn't get much coverage, on paper at this stage in phase II is better than Bimzelx. That's another option with a different mechanism. That's going to do very well. Oral TNF, we'll find out. I'd like that to be still there. Rilzabutinib 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. This is more your world than mine. We were seen as safe and boring. I think once we took more R&D on, people started to get a bit bipolar on what they felt. We knew it'd be bumpy. I didn't think this year, as we've advanced the pipeline, 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 for Itepekimab. E. coli was a shot with J&J, literally pollen the pond. I would 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 by. FREXA, we get closer to the goal.
Duvakitug with Teva, the Tier 1A, another year has moved along the continuum. We get closer to readouts. While it's been painful, we just march along trying to get to the toll gate. I think that's quite nice. I'm humbled by the reaction from the market when we get the data. It shows you how finely balanced we are. The company's 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, and maybe Plavix in China. We decided that the company, we owed the company a chance to break out from that. There are 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 five to seven-year R&D turnarounds. I remember thinking at the time, we'll do better than that. I was completely wrong. Completely wrong. I have huge respect for Dave and Pascale. I was completely wrong. I should have signposted in front. That's exactly how long it's going to take. We didn't do it any faster. It'll 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. I take it on the chin.
I think Lunsekimig, FREXA, Duvakitug, Amivantanab, we're right where we need to be, and we're a year down the development journey, which, while people think, how do you cope with all the challenges and et cetera, I cope because when I reflect, we're a year down that journey. I can't make time pass by faster. We're accumulating that. We're happier inside than you guys are outside, but we know we still have some work to do.
Dupi, LOE extension beyond 2030 or more. You sort of toyed with the idea of potentially extending it or communicating extensions to the market.
You know, you guys get it. I think that's one of the reasons we got such a negative on Amelior, by the way. I think because we believe that it'll play a big part in our life after Dupi. 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 drugs. At this stage, we can put that number around, and we may get positively surprised. That's good enough for us to do what we need to do to be able to grow EPS through Dupi. 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'd be easier for me to tell you exactly what we're going to do, and then everybody goes, oh, well, 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 mine or 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. Heads down, get through the toll gates, launch the drugs with enough time for people to see that our run rate, we're sipping up $10 billion of new product sales by the end of the year, sorry, by the end of the decade. That's where we will be, plus more wins. We're in good shape. I hate waiting. I'm a very impatient person, and I'm learning to be better at that. We'll see. We're in a good spot, and we'll have to prove ourselves. That's our job.
Perfect. I think we're on time. One question at the back, maybe? All right, I should have taken that earlier.
Thank you. About vaccine, you have a partnership with Novavax. When do you think we'll get COVID and flu vaccine? With Translate Bio, you made an acquisition several years ago for $3 billion. What are the main targets now with this new administration, please?
We're passionate about the mRNA. We went from zero. Remember when we did Translate? I think Moderna was $186 billion cap that week. We picked Translate up for $3 billion to get a slingshot on the mRNA piece. We wanted to make sure that if mRNA became 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's sensitivity to mRNA, which is forced against us. Our mRNA programs around acne, chlamydia, other things are after this administration. Our timing was brilliant or lucky. Let's take the last one. 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 2027, most likely 2028. I think Moderna's at 2027, but not with the flu efficacy that we'll have, and they're mRNA. I don't think there's anything wrong with mRNA. We're in mRNA. The sensitivities around that at this time and at that time are still real for the administration and what's been happening. Luck or opportunity, I don't know, but a non-mRNA flu COVID without the reactogenicity, we hope, delivered in 2027 or 2028 could be the premium end of the future for the over 55-65s. That's great if we get there. I don't know if we'll get there. We got our mRNA. It's all for later in the cycle of pipeline for us. We've got the flu COVID. It was a good deal. We did some good deals, by the way. That was another good one. We'll see where that plays out.
Perfect. I think we're on time. Paul, thank you so much for your time.
Thank you. Thank you.
Thank you.