Okay, perfect. Let's get started. So, good afternoon, everyone. I'm Sarita, a Equity Research Analyst at Morgan Stanley, and I'm very pleased to have Paul with us today, the CEO of Sanofi. Thank you very much for being here. We're delighted to have you.
Very happy to be here.
Just before we get started, some housekeeping. Apologies if you've heard me repeat this multiple times, but this presentation is for Morgan Stanley Institutional Clients and Employees only. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. With that, let's get straight into it. I thought perhaps we could start with an update on U.S. policy, albeit I'm sure you're sick of talking about it. On tariffs, we're still awaiting the specifics, but how should we think about Sanofi's potential exposure to U.S. tariffs? Could you give us an indication of the percentage of U.S. sales driven by U.S. manufacturing?
Very happy to be here. Great first question. For tariffs, I think most of us have a placeholder of around 15% for 2025, and that's roughly what has been mooted. We haven't really given guidance, which is manageable for us. We haven't really given guidance for 2026 yet, so that gives us some time to see where these things turn out and how we're going to approach it. We've done the scenario work, and we feel comfortable with that. Like most companies, a significant part of the revenue and indeed the profit comes from the U.S., so it's in everybody's interest to take care of it. There's a few things up in the air at the moment.
We want to help the administration get done what they want to get done, but do it in a way that works for us, of course, for patients, for everybody in between. We hope there's a way to do that, and for my sins, I'll be incoming Chair of PhRMA in January after Albert Bourla, so I'm hoping Albert gets everything resolved beautifully between now and then.
In terms of the $20 billion investment that Sanofi has pledged, when should we expect those investments to come online? To the extent that you can share, what type of exemptions, if any, should we be thinking about for companies that have pledged?
I think we all pledged quite early on. I think the sentiment was shared by everybody, a mixture of what is planned investment, what will be additional investment, and it was never really separated out by line. It was just more an accumulation of what it will look like. For us, it was over a four- or five-year period and starting up ahead of us, but with the normal caveat that as long as the U.S. retains the attractiveness that it retains, then I think we're all likely to continue to make the investment. That was put on the table very early, and yet we still have a few open questions. Tariffs is one, and MFN and other things.
I would like to think that as we get to a final conclusion, that we can bring everything together rather than leave some whack-a-mole pieces that are still to be resolved.
Sure. And you mentioned the second policy risk in terms of MFN. So President Trump has been very vocal around bringing U.S. drug prices down and raising ex-U.S. prices. Paul, you penned a letter addressing ex-U.S. pricing and the need for Europe to perhaps pay for innovation. But do you see Europe accepting higher prices?
I think we all know that Europe should pay more, should pay for value. That was never really in doubt. Most of us have been in the industry a long time, have been communicating that for a decade plus. I think there's a few things to watch out for. One is that the prices might be a little bit lower, but the true apples-to-apples comparison between what the government pays in the U.S., the V.A., Medicare, Medicaid, etc., and what is paid by the government in Europe are not wildly apart. The real difference comes out of the commercial patients and the 4%, 5%, 6%, 700% difference, and often that is driven by the dynamics between PBMs, the companies, etc. I think the real issue is in Europe that 54% of medicines that are approved by the European Medicines Agency simply aren't reimbursed in Europe.
So it's a sort of a well-kept secret, good or bad, in Europe that medicines that are innovative from breakthrough aren't necessarily available, and patients often just simply don't know. You go and see your physician, and you say, "What is my treatment plan? I've been through radiotherapy. Where do I go next? I'm going to give you this med," and you say, "Is that the best?" And the physician may say, "It's the best I can give you." So we have to be a little bit careful talking about access and price and what that looks like because so few medicines are available in Europe. Lastly, we've had a lot of very lively conversations with the heads of state in Europe over the last weeks and months, and particularly since this new administration. It's often a zero-sum game in terms of healthcare budgets. So if prices are to go up in Europe, which perhaps they should, the pot stays the same, and fewer people get medicines.
Sure.
So I don't think it's as simple as a headline of, "Europe should pay more, declare it," etc. It's also not the NATO example where if you don't put more in as a percentage of GDP, will the U.S. be there to protect you? There wasn't quite that level of challenge coming from the U.S. So should Europe pay more? Absolutely. Will they? I'm not sure, although we keep pressing. Will the president's urgency and insistence have an impact? I would like to think that it will. It may not. And we should then focus our attention squarely on what does it take to make sure patients understand how to reduce out-of-pocket in the U.S. and things like that.
Sure. And of the various aspects outlined in President Trump's letter to the industry, where do you see the most tension? Which of those are easiest to implement in your view?
I was the, should I say, proud recipient of a letter from the President. It's a very detailed breakdown of, and followed with more pages, in fact, of the specifics of how to manage MFN and perhaps even into Medicaid. The devil is in the detail. And while I think I understand what's trying to be achieved, personally, for Sanofi, I want to make sure that we don't resolve a piece and leave other pieces open, and that we try and bring all of it to the table.
And while we have a lot of empathy for the President's determination to bring prices down, etc., I think we also have to be honest with ourselves that letters and executive orders are not legislation. There's still a long way to go to try and make changes. I think the PhRMA and the members need to work very hard to help give the administration what it needs, but also be fully aware of the consequences and not leave too many gaps in what could come next and around the edges. That's still not resolved.
Sure. And Sanofi outlined, going back to the 2023 R&D Day, nine assets where you saw peak sales potential of $2 billion -$5 billion or $5 billion plus. And we started this year to see updates from that pipeline. So while we investors appreciate that R&D is, of course, inherently high risk, could you speak to your confidence in the internal pipeline moving forward?
I can speak very specifically to my confidence. For me, I think we've had quite a challenging year. We advanced the pipeline great. We're growing high single digit. We have a great balance sheet. We're more modernized and smaller, 40,000 people smaller, in fact, than when I joined. We're doing all those things correctly, but I think the Sanofi story still hangs in the balance of can we get the R&D done. And the company has not had a rich history of doing research and development. We're one of the youngest big Pharma companies, but still, we haven't seen a drumbeat of successes. I'm very proud of ALTUVIIIO and Hemophilia A, Beyfortus, the progress made there. You've seen the Dupixent development, incredible what we've gone on to do there. But we recently had our IL-33 at Itepekimab. We had one big success pivotal and one failed pivotal.
That's perhaps one of the most challenging situations of all because we still have to make a decision which way to go through. I think we will go forward. We just haven't decided the way to execute that yet. And we still think we can be extremely competitive should we do that. But there's still some decisions to take because if we do go forward, we want to make sure it will read out positively. A third study. It's a big investment, and it's a number of years, so we want to get it right. So we still believe in it. And that medicine, of course, has bronchiectasis readout in the next 12 months or what have you as well, so not too bad. Last week, I thought we took quite a bit of heat over Amlitelimab that read out OX40-Ligand, the first of the pivotal trials.
And I've got to be brutally honest with you. We got the data, and we were really pleased with the data. Of course, the street was less excited about the data, and we spent some time thinking about that. We met all primary and secondary endpoints. We even delivered a Q12 dosing interval. We had a great safety profile. But I think the street expected at a 24-week time period for us to blow past Dupixent and the data that it had. And perhaps an even higher bar for us than for other companies because it's seen as a Dupixent to Amlitelimab switch. All boats rise in immunology. I've spent many hours already today reminding people that almost every injectable drug in immunology is a blockbuster and that there are IL-31s and other things that have consensus numbers, 3, 4, 5 billion that don't even have the profile of Amlitelimab.
But I think the bar is high for us. Internally, we're absolutely thrilled with the data that we have, and it has to be reproduced. Externally, I think we need to prove with COVID-19 in the new year and then with the efficacy data that showed that the efficacy lasts for and that gets closer to Dupixent over a year. I think then people will start to understand that we're in very good shape on that. And we were pleased with the data, but we have to show everybody else why we're excited and why we believe. But that's going to come over a little bit of time.
Sure. I do want to go into Amlitelimab and into Itepekimab in more detail, but before we get there, have the updates that you spoke to this year changed the conviction in the ability to grow through the Dupixent patent expiry?
We're looking at 2031, 2032 for Dupixent LOE. Of course, we have strategies like you would expect of us, and those strategies are not shared, but you should assume we're doing a lot of important work to make sure that we live as long as is necessary. I think that we said all along back in 2019 we need enough assets in launch mode to be able to cross the line of Dupixent at some point. Bearing in mind we only take 50% of the profit of Dupixent, so we really need around about 10-11 billion EUR worth of revenue from new product launches from this pipeline in particular that we get 100% of. We still believe we're in that situation. We're pleased with the Amlitelimab data, less pleased with the Itepekimab, but we think we can get there.
In flight with Beyfortus, ALTUVIIIO, Tolebrutinib, Rilzabrutinib, and then Lunsekimig and the oral TNF behind those in the pipeline. That should be enough, but we just have to be aware of the roulette of R&D in our industry. We probably have to add a few more earlier assets to add to that. Outside of that, there's the inorganic M&A, Blueprint, and other things that we've done to try and make sure that people can understand how the math works and stay in the sweet spots where we'd like to play with low marginal cost to deploy.
Sure. Very clear. And you touched on some, but what do you think the most important assets in the pipeline or the two or three that you think are most important to replacing Dupixent revenues?
I think if the Amlitelimab Phase 3 data and the second Phase 3 pivotal are positive, we can see a $3+ billion revenue in AD. If the asthma data and the population that we think we can target the high eosinophils and the full elevated neutral population, those two things together could take us 4, 5, 6 billion. Now, of course, ifs and buts, I accept that. On the low end of these things, but our profile we believe can get us there. Then Lunsekimig seems to be the standard of care in efficacy in asthma. That's an IL-13 TSLP. Frexalimab in the CD40 in MS, we think that's a blockbuster. We have our collaboration with Teva on the TL1A to TEV'574. I think that's in the blockbuster category. Then we have a few things further back.
As always, I'll add something I haven't come to address here afterwards, but I think I'm excited about the $2-$5 billion medicines that we know how to commercialize. I think people accept Sanofi knows how to commercialize, but people would like to see us get our medicines through the phase 3s and submit it successfully.
Great. And Paul, you mentioned BD, and we've seen a number of in-licensing acquisitions this year: Dren Bio, Vicore, and then the larger Blueprint. So how should we think about BD priorities moving forward in terms of deal size, therapeutic area, stage of commercialization? Perhaps Blueprint was a slight shift in strategy to a later stage commercial deal. Should we expect more of these as we move closer to the Dupixent LOE and given pipeline updates?
We've guided for the last 5-6 years on the $2-5 billion range, and I think the biggest deal we've done before Blueprint was maybe close to $4 billion for Principia for the two BTKs, Rilzabrutinib and Tolebrutinib. I think we felt quite comfortable there. We had no desire to even go as high as Blueprint, but it became clear very quickly a couple of things. Ayvakit was going to be a success. They'd already launched it with de-risked, and an estimate behind it was a great transition so that we wouldn't have to face an LOE cliff in the next decade plus. With a shot on goal of 808, the promising kit that they had in their pipeline. It fit together very well for us in terms of our rare stroke immunology pipeline, and we have expertise there.
Something else that came with it, and particularly now that we have Amly data for COVID-19, is our ability to use the infrastructure in the key markets, the U.S. principally, through the U.K. and U.S., to be our immunology backbone so that using the Blueprint infrastructure, we could put Amlitelimab in and then Lunsekimig in. Yes, we would grow that infrastructure a little bit, but not disproportionately. So our marginal cost in pulling through the assets in that infrastructure would be much more positive for us because I think many of you know, my good friend Len will often share, we can't use the Regeneron Alliance for our own assets because they sit outside the Alliance. So we wanted to do that on the back of a Blueprint. So we guided that we might go as high as high single digit with Amly to Blueprint.
There are very few targets of that ilk around that would get us excited and that would be right in our sweet spot. If we get the transition of the phase 2s and 3s and the submissions as expected, you'll see us move earlier and earlier in the acquisition, so preclinical phase 1 and maybe as late as early phase 2 or phase 2 ready because we don't need to pay huge premiums. We do need to keep adding to the pipeline, expecting that there's some risk around some of the programs, but we feel less necessary to be revenue-generating assets going forward, and we are one of the fastest growing companies as we are, so it's better just to focus on how we can create future value and future growth.
Paul, you touched on the Regeneron collaboration and perhaps not being able to use the Dupixent strong position as you come to launch Amly pending COVID-19. So how should we think about the collaboration moving forward? Is there scope for this to be renegotiated and for assets to enter?
Look, the contract and the opportunity to renegotiate is there. It's always been there. And I think my good friend Len Schleifer would like nothing better than to negotiate. So we have a great relationship. We have a great asset in Dupixent. We hope Topekamab can make it through as well and get the benefits of that. But it's interesting, right? And I asked myself a little bit why after the Amritelamab data last week was there such a difficult negative reaction. And I think it's because of the perception of those that observe our industry that we need to be able to get into a switch mindset: Dupixent to Amritelamab. First of all, that's just never the intent. It's just not necessary. Dupixent will grow to its very last day. It is growing faster now as two new drugs have entered the market.
It's growing faster than it's ever grown. That's quite interesting because biologic penetration of the eligibles is only 15%. So 85% of the patients that should receive Dupixent do not receive it. We'll be heading towards EUR 22 billion in 2030, and still penetration will be very low. There's so much room for everybody that as each new entrant comes, new mechanism, new interval, everything goes. All boats rise. It's actually not a switch strategy. It never was. It's complementary. We can launch Amlitelimab, make it a big success, and the sheer fact of doing that on our own will make Dupixent rise bigger because the pie got bigger. I think everybody wins. I think perhaps last week it was not well understood that you don't need to switch one for the other. You need to see both succeed. In these autoimmune marketplaces with heterogeneous patients, highly symptomatic, highly mobile and active, that can be achieved.
I'm conscious you've spoken to the fact that there's scope for market expansion, that there can be multiple blockbuster medicines in AD, and you've articulated very clearly about the building blocks for taking Amly to the $5 billion-plus drug. In terms of other potential upside drivers on Amly, how important do you think the 12-week dosing is from a differentiation standpoint? I think this was a bright spot perhaps in the data that people didn't anticipate. Then secondly, how important is the plateau? We haven't seen one yet, and do you think that by week 48 with the EASI data next year we could see more Dupixent-like efficacy? You alluded to it perhaps earlier.
I like your summary. I think that we know OX40 ligand and have a slower onset. We know that certainly for Amlitelimab, you start to see an impact on itch quite early in the four- to five-week timeframe. The patient gets that reinforcement they need to know that they're on the right treatment. Patients will often accept that if they think it's a very long interval. If you're doing four injections a year, that will be the standard in terms of convenience. I think why Amlitelimab will do well is because people are starting to understand that as you sort of reset Tregs, there is a chance to come off medicines eventually. You'll get to do a little bit of homeostasis. You will get to a point where patients can be symptom-free.
In our open label extension of patients that have had a year's treatment, 70% of them that were a year off drugs still had not got symptoms. So we think Amly's position will be just very different than others in the market, but that over time people will see it as extremely attractive to have a long interval and to not know where the plateau is. Dupi onset of action is very fast. I don't even need to make a comparison. Dupi's the winner in AD, but at 24 weeks it's not an entirely fair comparison.
We'll get to the EASI data. We will see. Again, we don't seek to compete with Dupixent. There's just simply no need. We seek to get the biologic penetrations of the eligibles to 30%, 40%, 50%, more like psoriasis and rheumatoid arthritis. In that expansion, which would put the market at threefold what it is today (imagine that), we will participate in that successfully. That's what's exciting for us.
Very clear. And I appreciate there's many more pipeline and products to go through, but I did want to switch to margins. Alongside Amlitelimab, it has been a source of investor focus. Sanofi has previously highlighted and committed to growing absolute business operating income year over year. But how should we think about the margin trajectory for the business?
Well, we did a Q2 earnings, and we took a little bit of criticism for how we articulated the margin opportunity. I think we're rarely. I don't have any quarters. I've done like 24 quarters. And it was the first time I was a little bit taken by surprise and the reaction, principally because while we're doing a lot of great work to ensure we're becoming increasingly more profitable, we felt that we didn't need to answer that, not answer that question, provide content on that for the quarter. It was a mistake. It was a mistake. And I think after Itepekimab had failed one of its pivotal trials, people quickly said, "Well, can we just go back to banking and improving financial performance while you come with other data?" Not unrealistic. I thought we handled the question badly in the call.
I think we still felt that this was known and understood, and it simply wasn't, and so we've gone to great lengths. You'll see us very explicitly, I hope, at Q3, trying to help people understand that we're going to share with you the work we're doing to get there, so we've talked about it earlier, but we're almost 40,000 people less than we were. A third of our manufacturing sites have been divested. We're using AI at scale, and we can talk about that if we have time. We have got a mixed opportunity as we move the portfolio more towards specialty from primary after all of these years. The Dupixent improvement in manufacturing process has meant a significant decrease in cost of goods, and now that's fully annualized, so now we're starting to get the real benefit from that.
There is, of course, and as everybody's been asking me today, there is the Amvuttra royalty of 30% beyond EUR 1.5 billion. And as we said at Q2, we take the Evaluate number. We look at that and consensus. We don't forecast it ourselves, and we don't have any special insights from our lineup, so don't ask. We know that it's doing well and sooner than expected, but we also know we lose the Dupixent development balance.
So we think converging all of these things together gives us a chance to become increasingly profitable, expand the margin, and show people that we can flatten G&A but still invest in it where we think the opportunity for growth exists. And we are deploying well on the growth side. We've seen that with a double-digit top line. We still can squeeze further on G&A and other things and all the list I've just mentioned, and that's our job, and I think we're comfortable getting there, and we'll share a bit more explicitly about that at Q3.
Perfect. You preempted my next question, which was on Amvuttra. So in terms of 2026 guidance, Paul, you spoke about Evaluate consensus and perhaps not fully appreciating the Amvuttra opportunity. So would you use consensus as the basis for 2026 guidance?
I can only tell you what we shared at Q2, which was the Evaluate numbers. It's in the deck. You can go and take a look, and that's all we publicly communicated. I've not had to say too much about it. I know that everybody's been telling me it's been better than you communicated. Let's wait and see, and let's see where we get to. It's clear that it's a significant opportunity for other income for us. We wish them well and success with all of that. It comes at a good time for us in our journey. We take that. We hope that they reach for the stars. When we're ready to communicate any different number, we do that publicly when we feel ready.
Sure. And in terms of, I'll speak to my estimate. So in terms of my peak on the Amvuttra royalty stream, we're looking at something like $1.8 billion type of tailwind on the P&L. We are aware that Sanofi don't have the rights to the next generation, our Alnylam medicine Necritoran, which they're looking to launch in 2018 and PN in 2030 and CM. So is there scope to renegotiate to gain those royalty rights? And how do you see managing the loss of the income at a time perhaps where you will manage the Dupi loss through the P&L as well?
I think it's a fair question, but a little bit ahead of yourself given that we've just had all the questions on are we pleased with the performance. I think I haven't spent a lot of time studying the follow-on, but my appreciation for it is it's designed to be slightly more infrequent, and who knows how that will look. I think a company in our shape with our pipeline and our mid-late-stage pipeline and assets that are launching 2027, 2028, 2029, it's in our interest to enjoy the relationship as it is right now. But of course, we never say never.
Okay. Perfect. And perhaps we can switch on to some of the other key upcoming new launches. So we're expecting Tolebrutinib and SPMS, and one area of focus has been the label and what we can expect in terms of liver monitoring and precautionary statements on the FDA. Should we expect this to trend in line with what we've seen in the phase 3 trials? And how do you then manage perhaps the liver monitoring with the bolus of SPMS patients that we're expecting to come through?
We'll wait and see what the label looks like. There's no point trying to get ahead of ourselves. We're not that far away from the PDUFA, and this is the only drug with real data in non-relapsing secondary progressive MS. It's a 30% reduction in disability progression. We believe at the beginning 10%-20% of MS patients fell into this category. We're now looking at chart audits and things. We think it's more than 30-plus%. We know that many physicians in the U.S. will not write up a patient as being non-relapsing SPMS because that means their insurer won't cover them for their Ocrevus that they may currently be on. So we know it's underreported, and that's quite a big deal. Let's assume we don't know, but the protocol for monitoring is similar to what we were executing in the pivotal program.
That was weekly monitoring for the first 90 days. That seems very sensible to us. It was a choice that we made to go to weekly monitoring. It's something that's manageable for patients. We know where there were some cases of elevated liver that were picked up in the monitoring within a week that returned to normal. So that seems to be the most responsible way to approach it. We will see if the FDA thinks that is also the most responsible way to approach it. We don't know. The bolus, therefore, which I think is significant, either not correctly diagnosed or deliberately not diagnosed, and given the level of progression and what it means to patients is so terrible, we think there is a bolus.
But I think, and I've said this to a few people today on Feditoro and team, the real priority is making sure the monitoring is as perfect as we can possibly make it. So we're the only medicine. We're already growing double-digit as an organization. So let's do this nice and calmly and perfectly. Let's make sure that we execute it seamlessly on a weekly monitoring if that's what the FDA gives us so that every patient gets the absolute most perfect care, then goes on to get the benefit. There's plenty of patients and plenty of time to get that right. I think I'm not saying that it's one or the other, that if there's a bolus that you don't execute monitoring correctly, but I just want to make sure monitoring is the priority in the short to medium term while we establish that. From there, we will grow very nicely.
Okay. Thank you. Do you think that there's upside on street launch expectation? It's set less than $50 million this year.
I think it'll depend a little bit on the label, and if the label is in good shape and monitoring is manageable, then we will see.
Okay. I had to try. In terms of the vaccine business, Sanofi have guided the flu sales to decline mid-teens this year. How should we think about the vaccine business moving forward, managing some of these pricing headwinds? What type of growth outlook should we expect?
It's clear in flu on the commodity side of it, the standard dose, it literally is a commodity. We've also seen one organization decide to externalize its vaccine business because it is extremely competitive. We've enjoyed incredible success in the high-dose flu vaccine segment, and the data supports the fact that you will protect more lives doing it that way with Efluelda or high-dose flu. We're very comfortable with how that premium segment we've managed to achieve a great deal of success. It is also true that coverage rates have declined slightly, and we will see how we look for the season, but coverage rates have declined slightly. There's a little bit of legacy fatigue from COVID and everything else, or people making a choice between COVID and flu and not wanting two injections. We get all of that.
We do believe that the premium segment of flu will fragment again with flu-COVID combos in the 2027, 2028 horizon. We signposted that quite a long time ago, but I think we see that we got perhaps a little bit fortunate. We were able to pick up the Novavax COVID-19 recombinant target reasonably efficiently for not a significant amount of money and then drive the combination with our standard of care in the high-dose segment. We could offer a non-mRNA flu-COVID combo. While perhaps that shouldn't be a big deal, I think this administration in particular would like to see a non-COVID, sorry, a non-mRNA flu-COVID. Of course, we've all had our own experiences.
We're in mRNA too, so please don't misquote me, but we know the reactogenicity in some of the adverse events that people had. We know that's critical, particularly in times of pandemic. Expectations now in peacetime with flu-COVID are very different, so we think the established platforms may go on to be the winners. We think that could be us in the 2027, 2028 horizon.
Very clear, and I appreciate I haven't left you very much time to answer this question, but as a final wrap-up, what do you think, and we touched on the Amly data, but what do you think that the market is misunderstanding about the Sanofi story? Where should we be focused that we aren't currently, and what are we as sell-side analysts getting wrong?
I think that we work very hard to turn ourselves into an R&D-led bioPhRMA company. You don't need to worry about that. That was our job. We've done that, and we've shown that we can execute and commercialize medicines. They taught us ALTUVIIIO, Dupixent. We've shown we have commercial chops when you get things done. What we're waiting, and I think the market is waiting to see, is a series of pipeline successes that they can understand. I think we were dinged a little bit too heavily last week, but I think it's because the expectation of Dupi to Amlie. I think what you need to think about is how big can Amlie be with this profile?
You can't, in the same individual sometimes, disconnect, say, an ALTUVIIIO at $3-$5 billion, depending on who you are, with the worst profile from an Amlitelimab, which has got so much promise ahead of it in disease modification. I think just ask for a bit of balance, but you don't have to do that, right? You can wait and do what you want. No LOE till 2031. Great balance sheet, great top-line growth, free shot with the pipeline as we're valued right now. We're excited about what it's going to mean over the next sort of 6-12 months as we get those rebounds.
Perfect. I'm overworked, so.
Yes. No.
I hope we can't do that.
Yeah. Thank you.
But thank you very much for this great chat.
That was fantastic.
Thank you so much.
Thank you.