[starts abruptly] You have joined the meeting as an attendee and will be muted throughout the meeting. This meeting is being recorded. 2023 results followed by a Q&A session. As usual, you can find the slides to this call on the investors page of our website at sanofi.com. Moving to slide 3, I would like to remind you that information presented in this call contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. I refer you to our Form 20-F document on file with the SEC and also our Document d’Enregistrement Universel for a description of these risk factors. With this, please advance to slide 4. Our speakers on the call today are Paul Hudson, Chief Executive Officer, Jean-Baptiste de Chatillon, Chief Financial Officer, Houman Ashrafian, Global Head of R&D, and Julie Van Angeval, Global Business Unit Head, Consumer Health Care. The Global Business Unit Heads Brian Ford, Thomas Triomphe, and Olivier Charmeil will join for Q&A to which you have two options to participate. [Operator instructions]. And with that, I'd like to turn the call over to Paul.

Well, thank you, Eva, and thanks to everyone for joining our call today. Before we discuss this quarter's highlights, I want to start by updating you on other announcements we made this morning. We've reached an exciting moment in the transformation of our Company here at Sanofi. Our play to win strategy is working and we've made significant progress over the past years to transform our R&D efforts with a sharp focus on best in class or first in class medicines and vaccines. These efforts are reflected in our results. We're driving solid performance, seeing strong market demand for our recent launches, and advancing our innovative pipeline. Sanofi has delivered an unprecedented cadence of positive news and data readouts this year. We see significant growth potential in our pipeline on increasing our R&D investment accordingly to ensure we fully capitalize on the growth opportunities ahead of us. Houman Ashrafian, our new Head of R&D, will share his vision and first impressions in a few minutes. This morning, we're also announcing an important next step in our journey, our intention to separate the Sanofi consumer healthcare business at the earliest in Q4 2024, through the creation of a publicly listed entity headquartered here in Paris. This milestone is a win-win. It allows Sanofi to become a pure play by a pharma Company. We'll be more agile, more focused on our key areas of strength. At the same time, it allows Sanofi CHC to be in a better position to pursue its own business strategy, resourcing and capital allocation. You'll hear more from Julie van Ongevalle later on the call. We're excited by these new developments that will unlock value, coupled with the current strong business momentum with increasing sales from our growth drivers in specialty care and vaccines. No meaningful LOEs…

Yes. Thank you, Paul. Moving to Slide 13 and looking at our year-to-date performance. Sales grew 3.9%, driven by the strong performance of Dupixent Sarclisa, strong recovery of the booster vaccine franchise and by our six recent launches. R&D expenses grew 1.6% at constant exchange rate and benefited from a favorable comparison, as we booked some provisions following the termination of Amcenestrant program last year. The BOI margin decreased 0.6 percentage points to 31.4% due to the significant impact from the [ph] OVIGO LOE our last significant LOE until the end of the decade. We are also annualizing the Libtayo agreement, including a faster repayment of the antibody alliance development balance now at 20% of the Regeneron project. EPS was up 4.9% during the first nine months, helped also by the financial income due to higher interest rates on investments. On Slide 14, we are providing an updated H2 business outlook. We expect Dupixent to continue to grow driven by demand, while OVIGO sales are expected to be impacted by the entrance of generic players in Europe in Q4 on top of U.S. and Canada. Our expectations regarding the split of flu sales between Q3 and Q4 are now 70% on 30% compared to previously 2/3 and 1/3. Total net sales are expected to decline in the mid-single-digit range. Importantly, as mentioned by Paul earlier, we have raised our expectation for sales from our three new launches combined to exceed EUR 500 million. On the P&L, we expect the final COVID revenues of EUR 400 million in Q4 to be booked in the Vaccines other revenues line. OpEx should continue to grow at constant exchange rate driven by investments behind our key launches, increased R&D spend as well as costs related to CHG stand-alone. Unchanged are our expectations on capital gains on annual tax rate. In Q3, we recorded around EUR 100 million of capital gains. Based on the ongoing strong performance of the [ph] OVIGO LOE supported by the recent launches, more than offsetting the [ph] OVIGO LOE pricing headwinds especially in Genmab, we are reaffirming our full year 2023 guidance with EPS to grow mid-single digit at constant exchange rate. On a reported basis, we continue to experience headwinds from currency approximately minus 6% to minus 7% for the full year based on October average exchange rates. I now hand back the call to Paul.

Well, thank you, JB. Now let's turn to our next chapter of Play-to-Win. Since we outlined our Play to Win strategy in late 2019, we have delivered everything we said we would do. With Dupixent, we created a mega brand. In R&D, we lead in innovation based on our commitment to first -- best-in-class medicines, and we're building on our core key areas of strength around an industry-leading immunology pipeline. Our Vaccines business has delivered the mid- to high single-digit growth as per our guidance. And we have streamlined the Genmab portfolio, adjusted the geographic setup and go-to-market model. And we transformed the CHC business with the consumer at the center. Following this tremendous progress, we have now reached a point where we must accelerate our investments in R&D and with the proposed separation of Consumer Healthcare have an opportunity to take further steps towards becoming an R&D-driven pure play by a pharma Company. It's with great pleasure that I now hand over to Houman, Head of R&D, who will share more insights into our R&D journey and our pipeline's potential. Houman and I have been working closely together and the team and I value the unique and certainly fresh perspective he is already bringing to the Company. Houman?

Thank you, Paul. I'm thrilled to join Sanofi, and I'm looking forward to working closely with our teams, building on the significant progress that's been made over the last four years and actively we're shaping the discovery and development portfolio. It's been just over four weeks that I've been working at Sanofi. I'd like to use this opportunity to share some of my early observations on both the organization and the rich and diverse pipeline using Anetumab recent differentiating data presented at EADV, a couple of weeks ago as an illustration of how we are poised to embrace the next chapter of our accelerating growth journey. My focus as the new Head of R&D, is to ensure that we continue developing breakthrough medicines and vaccines to improve people's lives, while sustaining growth in our key therapeutic areas driving shareholder value. I also want to continue to position the Company and further focus it as a scientific and innovation leader, offering meaningful therapeutic and innovative options to patients globally, adding value to society. Our pipeline today is centered around six major therapeutic areas, benefiting from a broad range of proven mechanism of action and technology platforms. We are building on an industry-leading immunology pipeline with the ambition to be the leader for the next 25 years, but I'm equally excited about our presence in neurology, rare diseases and vaccines. This commitment is rich, thanks to our talented and dedicated international team, many of whom I've had the pleasure of meeting our various R&D sites and town-halls globally during my first few weeks on the job. Sanofi is strongly deploying AI, data science and computational expertise throughout the R&D engine to further accelerate our efforts and deliver better and faster options to the future. As part of these efforts, leveraging my recent…

Thank you, Houman. As I mentioned earlier, I want to say a bit more about our intention to separate our Consumer Healthcare business. So you see, we're set up as a business unit in 2014, followed by the integration of the Boehringer Ingelheim brands, until 2019 remain fully integrated into the pharma organization. You could say like prioritization, consumer centricity and kept performing below the market. Our decision to create a stand-alone unit four years ago enabled CC to set the right priorities, accelerate growth. Today, we've completed the stand-alone set up around a highly competitive portfolio and built a future-ready organization, consumer-focused and brand let. As a logical next step to fully unlock the value of the CHC business, we believe that the intended separation would equip it best to pursue its own business strategy, resourcing and capital allocation for sustainable growth. We are reviewing potential separation scenarios and believe that the path most likely to maximize shareholder value will be through a capital markets transaction. To create a publicly listed Company and headquartered in Paris, subject to market conditions, the separation could be achieved at the earliest in quarter four 2024. We're very excited about this announcement and the future prospects of both Sanofi and CHC. With this, I hand the call over to Julie to add her perspective.

Thank you, Paul. I am very proud of what the team has achieved since we embarked on our stand-alone journey, creating and embracing our complexity, elevating our consumer centricity and building our data in digital edge, all while creating our stand-alone. And today, we are ready for the next chapter. We are a global leading player with a strong focus on our 15 priority brands, all with global or local top three positions, of which most are holding number one positions in their respective markets. These 15 priority brands now represents 2/3 of our business and have generated 85% of our growth in the past three years. Important to note is that we're successfully operating in the attractive EUR 200 billion OTC and VMS market market, growing both in value and in volume year after year. Compared to other consumer markets, the VMS and OTC market enjoys attractive margins and rather high predictability. We have built a pure play leader with over 80% of our revenues from OTC and VMS, fully leveraging our diversified footprint across categories and geographies. With our clear strategy and consumer-focused brand-led organization in place, we believe the intended separation comes at the right time to further increase our focus, agility and speed and effectively leverage our industry trends. With that, I hand the call over to Jean-Baptiste for the financial update.

Thank you, Julie. On Slide 26, let me remind you of our success in delivering on our financial objectives during the first chapter of Plato Wind, 10 consecutive quarters of growth, 540 bps BOI margin improvement on EUR 2.7 billion of cost efficiencies, which we reinvested behind growth drivers on our pipeline. We also deployed cash in more than 25 value-creating transactions, securing access to external innovation in R&D. The digital transformation is a key area to enable further productivity, and we are today, employee insights from AI and predictive analytics across the organization. Today, Sanofi also benefits from a greatly improved cash flow generation. In December 2019, we outlined our capital allocation policy and have demonstrated discipline in executing on those priorities, investment into organic growth through our pipeline, our growth drivers remains our number one priority, followed by M&A and business development, focusing on bolt-on value-enhancing opportunities to drive leadership in core therapeutic areas. We continue to grow our dividend and expect to maintain that policy including in 2024 and regardless of the proposed CHC separation. In summary, I'm confirming that our capital allocation policy remains unchanged. On Slide 28, as Paul already mentioned, given the potential we see in our pipeline, we plan to grow our R&D spend in '24, up from around EUR 6.8 billion expected in '23. The spending level is already higher compared to EUR 5.5 billion in 2020 and is mainly driven by the investment in vaccines, R&D on the mRNA Center of Excellence. In pharma, we also benefited from reallocating investments, first from cardiometabolic and lately from oncology. We expect a further step-up in R&D spend in 2024 as we start a number of exciting mid- to late-stage programs in immunology, MS and vaccines. In 2025, we expect to be able to…

Thank you, JB. I want to conclude by stressing again the impressive progress we've made since the launch of our Play to Win strategy in 2019. We said we would deliver and we did. Today, we are reconfirming our 2030 goal to make Sanofi modern science-driven health care Company, an industry leader in immunology and in vaccines with greater than EUR 22 billion and EUR 10 billion of sales by 2030, respectively. We are confident in our improved R&D productivity, driving a pipeline made up of at least 70% biologics and the vast majority of products being best-in-class or first-in-class. This lays a promising foundation to bring three to 5 products to market with EUR two billion to EUR 5 billion peak sales potential each in the second half of the decade. We're in a unique position compared to our competitors with a portfolio uncompromised by a meaningful loss of exclusivity for the remainder of the decade. We are looking forward to the long-term growth prospects opened by our decision to increase our R&D investments. With that, let's open up the call for Q&A.

[Operator Instructions] The first question will be from Luisa Hector, Berenberg. Luisa?

Oh, hi there. Thank you for taking my questions. So, on the increased R&D investment, could you comment on essentially, why now? So why has it now become clear that you need to make this step up in your R&D spend? And can you give us any internal indicators reasons why we should be positive in this increased spend. Just sort of help us understand that the transformation is happening and that these dollars will be invested wisely. So that's the first question on the R&D investment. And then maybe on Dupixent, just you've got your guidance there for EUR 13 billion for next year. So could you comment on how the formulary negotiations have gone to date and your level of confidence in that EUR 13 billion clearly Dupixent performing very well.

Okay, Luisa. J.B., maybe you make a comment on the R&D investments first.

Yes. I guess the question is why now on -- is quite clear for us. We were committed to our 2025 BOI margin target since we announced it, and you have seen our journey towards it. As our successful readout of the past few months continued to come in, we worked on various options on how to develop them without wanting to take investments of our launches. And bearing in mind that the headwinds to Gen Med not being reversed. So those options included R&D phasing, selection, potential partnering. But we discussed various strategic options at our Board meeting yesterday, we decided to take on the option to accelerate and fund the full potential of our promising pipeline. We believe this is the best option for the long-term value of Sanofi, our shareholders and also for the patients who we serve.

And I'll come to you, Houman in a second. And of course, we come off the back of things like amitelimaba, EADV, [indiscernible] mentioned. We -- as you know, a lot of our development work is happening and discovery work is happening in immunology. And you know our probabilities -- is higher plus the importance to bring everything forward with some urgency is also there. So coupled with what JB said, I think the timing is good to say it now. Houman, maybe something confidence as well why do we believe it will be more successful?

Thanks, Paul. And thank you, Luisa, for your question. Coming into this with relatively fresh eyes and an objective perspective on the portfolio, we really have the opportunity to figure out exactly how we were going to move forward. And having evaluated, especially our leading product, I personally felt with the support of the Excom and the broader group that it was important that we should double down on many assets, which we really wholly own and which could be transformational. Importantly, moving these assets forward in the service of patients and our shareholders across a broad front, which is critically important at this point for many reasons, including the macro and some of the legislative changes that are coming in, in the future and have already come in; one thing I should reassure you to the second -- of your sentence was about how you can be reassured that we're thinking about spending every dollar wisely. Much of the expenditure will come through thoughtful reallocation towards the first and best-in-class assets. And we will ensure that every dollar is spent both in the service of our shareholders and importantly, in our patients really very carefully. And you'll see that peppered throughout the conversation thus far.

Yes. And of course, at R&D Day, we can really put our cards on the table. I think that's going to be important.

Yes, Paul, thanks for pointing to that. I invite you all at this point -- December 7 R&D Day, and we look forward to sharing the details with you in greater detail there.

Yes. And I think before I come -- I'll throw it to Brian on Dupixent in a second, but also, I think it might be worth recognizing although, we have a new head of R&D that has a more unique profile, both, if you like, skilled in science, but also in capital allocation, given its background. And it's unique, and I think that's already being put to work for us because there's a great awareness for how we spend and how we create a return firstly for patients and investors investment. Brian, $13 billion, And how confident are you of the formula status?

Thank you, Luisa, so much for the question. We've always had very good formulary status, and we've worked very closely from the very beginning with the strategy with the payers. And as we've said before, today, even we have more than 70% of our coverage is actually commercial coverage. And so we feel very good about the negotiations going into 2024. But I would start by saying, as we talk about the confidence, not only with the payers, but the companies we have in EUR 13 billion, it begins with the profile. We've got a profile that is quite unique, targeting IL-4, IL-13. We have 5 indications now in atopic dermatitis. We have 5 years' worth of data now in our label, both in the EU and in the U.S. We're down to the age of six months of age for young babies. So we have quite an incredible profile, and you look at the growth that we continue to generate year-on-year, it's quite impressive. And so be hard not to be confident in a brand like this. And so I think as we shared with you before, we shared with you, I think, back in 2019, the way point of EUR 10 billion first, we went back, it wasn't that long ago in 2022 -- the beginning of 2022, just over a year ago, we gave a new -- point of a little bit greater than EUR 13 billion. And now here we are talking about reaching close to EUR 13 billion next year. It's quite impressive. So we feel very confident, I think, in the continued growth of this brand and a leading profile across all the indications that we compete in. .

Thank you, Brian. Maybe just add then finally to that. With our delivery on Beyfortus and -- the great work that's been done to prepare ourselves for Tzield and the deliver on DUPIXENT. There's a sort of operational alpha about this Company, and it makes you feel very confident about money well spent bringing great medicines through can get launched really well in this Company. And I think it's important not to lose sight of that.

Next question is from Emily Field from Barclays.

Maybe just to piggyback on one of the last answers. You talked about doubling down on some of the programs that you're advancing. I was just wondering if we could get some more granularity on that because I think, at half year results, we talked about amatelimab and frexalimab going into Phase III. So are these studies going to be larger than initially planned? And then second question, just on Gen Med, if you could provide some color, I know you gave a number of products that you're targeting for '25, just maybe more on the sales expectation and just the impact of that sales expectation to overall BOI margin. Are those higher-margin products that are coming off just so we can think about the moving parts getting to 2025 BOI margin. .

Okay. Maybe just a quick response for me. The -- we'll go through this at R&D Day. I understand that why you asked the question, going more broadly with amnitelimab, potentially going more broadly with -- potentially, when we look at the oral small molecule TNF, we have only shared one piece of data, I think, in psoriasis from recollection with an intent to go to a couple of indications. When you look at the IRA, you look at a small -- you go, you know what, if we like the data, we're going to have to run parallel studies to bring this thing through to fully prosecute it. They're the sort of things that we're starting to say to ourselves that frexalimab beyond MS. These are the things we'll talk with you about at R&D Day in December. But these are not inexpensive things to do, but are two good opportunities to miss, particularly with our ability to deliver and to launch. So again, December 7, we have a few hours on this, and it will be up to us to demonstrate that to you. But I think you'll see it. I think when you may be asking the question, okay, why now, what's different? Its urgency, it's confidence, it's breadth and it's a sheer intent to go all in to create massive future value. And we can perhaps do it in an optimized fashion. It just is not worth it at this point. The big -- the win is too big over the longer term. I think, Olivier, there was a question around Gen Med?

Yes. So thank you, Emily, for your question. So we are going to continue to simplify our portfolio. We are a little bit in advance versus our plan. We are now aiming at 85 product families for 2025 when initially we were aiming at 125 coming more than 350. It's very much directed by profile and gross margin. We want to focus our resource on the drivers that are going to drive profitability and brands that are going to drive growth. . What does it lead to in terms of sales profile? As Jean-Baptiste mentioned, we are no longer aiming to maintain Gen Med sales into '25 at the level of 2020. But we remain very, very committed to our guidance in terms of BOI margin between 220 and 225 and we are well on track here due to, of course, the pressure we put on OpEx, the efforts that are done by our colleagues from manufacturing to improve the cost of goods.

Next question is from Peter Welford from Jefferies.

First question, I guess, is going back to a point you to some extent, already covered, but I guess just curious why the decision now to talk about 2024, 2025 EPS and highlight the increasing R&D. I guess we would never -- outside world have known the increase in R&D plans until potentially the seventh of December R&D Day. So I should just outline, you know, why disclose that, the spending sort of now, but then give the details of the seventh of December? What was the urgency, I guess, in this sort of six weeks, if you like, preview rather than necessarily giving us all the information together then at the Capital Markets event. And then just secondly, if I just come back to Gen Med. Obviously, you've done the Tzield deal. I mean you've actually upgraded the sales outlook for the flat portfolio of newly launched brands. We've also seen Resinrock launch as well. Can we just ask with regards to the change in the product families. And I appreciate that obviously, you're pruning the portfolio. But equally, obviously, there's a lot of growth assets within that. So could you just perhaps give us some sort of clarity in terms of what sort of growth we should profile or I think we should be looking for, for that business? I appreciate that on the stabilizing. Is this a business where you think the current trend is going to continue? Or is it likely to accelerate given the commentary in the outlook section about more aggressive pricing dynamics that you're seeing for that business?

Okay. Peter, thank you very much. Jean-Baptiste, a little comment on '24, perhaps even a comment on '25 and a little bit around why don't wait until R&D Day? .

Yes. Well, that's a great question. But I think I tried to answer it just before that once you've made a decision through the governance and we had our Board meeting yesterday, we had different options, but we opted for this doubling down in R&D and science. So it's good practice to communicate without differing. Then on 2025, as I said, and it's difficult to understand why the R&D would plateau in '25 versus '24. But you have to keep in mind that reallocation exercise we are doing now with Zuman,, I must say, but it will still deliver the bulk of it in '25, not in '24 so that will come to give more leeway to the development of our I&I pipeline and vaccine pipeline. You have also to think that the studies on COPD and tolebrutinib will be dwindling and these costs will disappear, giving more room also to embark spend for our I&I pipeline and vaccine pipeline, as I said. So this is one point. On COGS and Dupi, remember that we will have the full impact of the improvement of COGS in 2025. And globally, the other elements of our saving plan will also mainly deliver in '25. So that's why we are concluding that we will have a strong rebound in 2025.

Thank you, JB. Okay. To Gen Med, I'll throw it to you, Olivier for a second, but just the general context, I think you know this, you said it. You have pricing headwinds that are simply too strong to be offset by volume even though our volume performance is pretty phenomenal. And that's an industry phenomenon, by the way, that's not as a post pandemic sort of fiscal deficit -- attention. I think we've coped very well, but it won't offset. The Tzield and -- and the sort of growth profile of the segment at the core, if you like, of Gen Med, Olivier? .

So thank you for your question, Peter. On the -- our growth is going to be continued to be driven by the growth of the core assets. We are very happy with the performance of Rasuvo. We are well ahead of our plan. We think that it will continue. And we'll talk more about a function of indication during the R&D meeting in December. We continue to be happy with the very strong growth in the international region, including China, by -- of [indiscernible]. And of course, [indiscernible] is doing extremely well in Europe, where in a very growing market and we are able in some countries to continue to grow our market share. . Just to give a little bit of color. I'm just back from Ispat. I've met lot of key opinion leaders on Tzield that was with Paul. And we are really happy, we are in line with what we had initially planned. In the U.S., we knew that it would be a slow ramp up. We know that the feedback from key opinion leaders and the product is extremely high. We are working through a very focused approach on a limited number of centers, it's about cleaning, it's about ways of working. It's about getting organized. We now have a little bit more than 110 patients and we have done a lot of progress since we took over Provention Bio in terms of making much shorter the period of time between when patients enter into the funnel and what they get infused. So everything that we see and the action plans that we have put in place makes us comfortable that Tzield will be a multibillion asset.

Next question is from Graham Parry from BofA.

So first one is just I think clearly, the series of announcements this morning caught the market off guidance -- the share price reaction. And I think what would help is if you can help people with narrowing of the scenarios for the '25 earnings recovery. So you said flat absolute R&D because I think you even actually -- just based on the savings you're talking about, and as your cost savings come through as well. And given that you have this big step-up into 2024, that's clearly going to see earnings down. But is it fair to assume, therefore, that the cut to earnings that people will be putting through their models is going to be less in 2025 than '24 because you've got revenue growth in these other savings coming through. . And then secondly, just what sort of aspirational growth are you targeting post 2025 through these investments again, think that some sort of communication of great -- at the end of the decade would be helpful for investors as well. And then lastly, on consumer, clearly, the argument for value creation here would be that appears in consumer trade or much higher multiples in Sanofi. But that rationale goes out of the window if you sell it for cash and then reallocate that capital into another deal. So perhaps some comfort for investors here would be what the preference on options is a spin-off preferred here. Or if not, what are the return hurdles through a transaction on the other side? Would it be EPS accretion? Or would it be MPV positivity? Just help us with understanding that as well. .

Okay, JB this looks like a few for you you and I from Graham Parry. So why don't we start with a little bit of '24 and the shape.

Well, I think Graham [indiscernible] is hitting a very important point is that something we have not reminded enough is that we enjoy an incredible and pretty unique growth profile of our top line. And that's for the years to come. What we are doing today is having in mind that we want to deliver for '26 onwards, three to 5 launches of assets with EUR two billion to EUR 5 billion -- sales potential. And that's very important today to remind this player value creation to a greater value creation in the midterm. The top line growth is untouched in the years to come, and I think it's pretty easy to read and will not even be bolstered with success like the one you see on [indiscernible] should I say something about CHG .

Yes, '25, a little bit more color on '25.

Well, I think I give the -- that was a missing piece that was that we will be growing in '25. So there's a strong rebound fueled by late R&D savings, reallocation, improvement on COGS, deep transformation of the Company, a second step in this transformation. All of this is really leading to a strong demand as soon as 2025 with the growth profile, which is untouched -- I think it's really too early to be more precise. We said we had a preferred route. But whatever the route we take, we'll keep in mind the best interest of investors. .

Next question is from Tim Anderson from Wolfe .

I just want to, again, stay on the guidance. How much of the pressure to earnings in '24 and '25 from below the line items versus on the revenue side, you're talking about Gen Med guidance no longer being the same as what it was. That would suggest there's some portion revenue shortfall on the top on the revenue side that drives the earnings reduction as you're suggesting the Street build in for '24 and '25. So can you kind of apportion the lowering to revenue reduction versus things that are below the line. And then on the below-the-line stuff, it sounds like it's not just R&D, it's not just tax, but that's also stepped up promo of certain brands, and I'm wondering if you have specifics to share there.

Okay, JB. On the pressure on earnings from below the line. .

I think the -- is everything which is below the top line. I understood. Okay, got it. Yes. Well, yes, because top line is pretty clear, you're right, and it's growing steadily. So I tried to give you that this step up -- so many difference is really R&D. Of course, it's altered by the shape of the decrease in Gen Med but mainly, it's really this decision of going all in, in developing the pipeline. You've seen that we've not been shy or mainly we went just recently, you've seen two big deals appearing the]indiscernible] TL1, which is a great complement to our immunology story and also in vaccine, the [indiscernible] Paul just presented, there are big potential. So in this endeavor to look for EUR three billion to EUR 5 billion peak sales. That's where we are. It's R&D, the main driver of the change.

The tax regulation changes?

Well, tax regulation changes -- thank you, Eva. It's Pillar 2. As you know, we have a tax setup, which had really improved a lot in the past 5 years, very steadily, decreasing the effective tax rate. With this minimum 15% taxation, some of the players, and we are one of them are hit by this change in regulation. That's the way it is.

Next question from Peter Verdult from Citi.

Yes. Thanks. Pete Verdult, Citi. I wanted to talk more about the pipeline, but I'll probably -- to wait for December given share price reaction. So apologies team, it's to on financial and commercial. Just again, just to go back to the guidance. I know, Sanofi doesn't guide on revenues, but in your prepared remarks, you did call out revenue growth expectations in '24. Can I push my luck and explore your comfort or the upside potential to where market expectations are currently, which is around mid-single-digit growth in 2024. And then secondly, [indiscernible] JB, Beyfortus in September at the launch, the message was custodies are great. The demand has been phenomenal. [indiscernible] are now being reported. So I just want to gauge how quickly you can ramp the capacities further near term, given the analog benchmarks, you're using a clearly sort of undercooking what's happening in reality. .

Thank you. Pete, I look forward to questions in R&D Day. JB, I'm not sure there's much to add, frankly, on beyond 2024 on revenue growth. .

We're not guiding, but our confidence, I think you can feel it to the team. We are a growing story and a growth story and such will happen. No, I don't think we can be much more precise at that stage. But I think maybe [indiscernible] .

So Thomas, maybe give you a little bit of our time to talk about the incredible launch. .

Thank you very much, Pete. Great question. Yes, absolutely, we are very happy about the launch of -- extremely excited by the reception of the product by the whole community, be it the providers, the payers, the public or private stakeholders have all played their part to make sure that there could be an accelerated uptake of the product. . What does it mean concretely? It means that it's the unprecedented level of demand for any pediatric launch over the past 20 years. So what does that mean? That means that all infant protection strategy works, and that's what people want, which is not the same, but some of the product can provide. It also means that it fits exactly what we have said in terms of the ability to be at the right path to make sure that it's accessible for everybody. Now we are working for 2023 with the different stakeholders to make sure that the Beyfortus doses that are provided to the market are used and that the maximum -- is protected. And as you pointed out, this unprecedented level of demand has created a challenge to be able to cope with the supply, which is manufactured by partner AstraZeneca for the -- so right now, we're working with CDC and with the different countries like France and Spain to make sure that all the doses get allocated and used as fast as possible. And of course, we're working with our partner, Astrazeneca to make sure that we can extend the industrial network, identify further solutions to meet this exceptional demand, not just now but for the future. .

Yes, I mean, incredible launch, and we've prepared well, developed the market prepared well appetite is phenomenal. And we'll keep bringing more doses online. That's the plan. Okay. Next question. .

Next question from David Risinger from Leerink.

I have two questions, please, one on revenue and one on biopharma margins. So first, could you please frame late-decade revenue growth prospects from the 2025 base? Should we be anticipating low single-digit revenue growth or mid-single-digit revenue growth? And then second, excluding consumer, in light of the Company's biopharma operating margin as it stands today and also 2025 prospects, has management and the Board reconsidered operating its biopharma business in such a wide range of therapeutic areas, products, pipeline candidates and geographies and concentrating in more profitable biopharma franchises like biopharma peers. .

Okay. I mean in terms of revenue growth, I can hear your excitement, but there's nothing for us to share on that at all, certainly not at this stage. And then discussions around if I've interpreted this correctly, around just focusing further by geography and TA looks ...

I think being a ...

Yes, to step back, sorry, to clarify. The Company's biopharma operating margin is at the bottom end of peers globally. And so it seems like that's a business mix issue. And the Company has a very wide range of activities in various therapeutic areas, various drugs, a wide range of pipeline candidates, a wide range of geographies. I'm just wondering if greater concentration would enhance shareholder value in the biopharma business. .

David, thank you for the clarification. Then just a quick comment on this. We are focusing to be a pure-play biopharma. The first thing we did, as you'll appreciate, is we doubled down on the R&D in the areas where we're already deployed. So the marginal cost to launch incremental vaccines incremental beyond damnetelimab incremental biologics. Of course, Dupi has kept separate. We have a moment to be able to have a low marginal cost to launch these assets over the future. That is how we intend to play. And so we've made sure in R&D that we're laddering up behind infrastructure that we already have or can develop efficiently. In the business itself, and I think Olivier touched a little bit on this. He's got the launches and the core assets. And then if you like, the legacy portfolio, because we have a wide portfolio, if you like, given the history of the Company between divestments and moving to digital and putting on carryover, we're making sure that we're actually focusing our efforts on where the growth opportunities are. So we may look wide, but in terms of if you follow the dollar against where the opportunities are, it's a much narrower less. I understand it's hard for you to see from where you are. I think it's one of the incredible things that the Gen Med team have done a more than -- or close to 9,000 people have left Gen Med over the past two or three years as we've got in pursuit of making sure that we are laser guided on the group opportunities. So that's a continuous process. We like that because that closes the operating margin gap over time and gets us to a good place. We'll see how much progress we make.

Yes. Next question is from [indiscernible] from Exane BNP. Okay. .

We'll ask Gary.

Let's go to the next for now. Next question is from Florent Cespedes from Societe Generale .

First question on 2025 onwards. How confident are you to resume sustainable growth beyond 2025. In other words, any risk to see another massive increase of the R&D budget? And also, could you give us a little bit some color on the operating profit margin profile. We understand that you no longer anticipate the target of 32% in 2025. But do you envisage you see some margin improvement in 2025 versus 2024 or even versus 2023? And my second question for Julie. Could you please remind us where do you stand regarding the [indiscernible] to OTC switch, the two projects [indiscernible], if you will be ready to, let's say, file next year or in 2025? Where are the clinical trials ongoing, please? .

JB, a question about '25 and then also onwards. Do you think will improve our operating issues? I think that was the question in 2025 and beyond. .

I think you have seen in our deck on our presentation that we have released three buckets, and it's a second major step in the simplification and restructuring of the Company to make it leaner. We are things where we were late on developing like core process modeling through hubs. We have set up a specific position in our ExCom to develop this at speed, and that will bring a new wave of efficiency. We have also decided to significantly restructure our commercial operations in country to avoid duplication and be much more efficient. So those steps are very meaningful for -- and they will, of course, participate not just on improving short-term profitability, but they will stay with us for the long term to be a more efficient Company. .

Julie, on switches. .

So thank you, Florent, for your question. On the switches, first, maybe on Cialis, I mean, the update remains consistent with what I shared previously. The necessary studies are underway, and we plan to discuss them with the FDA when they are complete and the data has been analyzed. For Tamiflu, we had several engagements with the FDA where they provided import feedback on the required studies and the overall program, and we're working collaboratively to incorporate that feedback and determine any impact. But so far, I cannot give you any specific update, but it continues. It remains a priority. .

Yes. I think that there's still a great path forward for perhaps Cialis, we're a bit more -- can be more transparent about because we can see it clearly after the latest conversations and the market opportunity for both is significant. So as and when we get the updates for share, but I think also they're very important value credit moments in the future of CHC. So I think perhaps that's why you asked it, but that's still very real. .

Next question is from Simon Baker from Redburn.

Two, if I may, would revisit some earlier topics. On the issue of 2024 and the reduced expectations versus what we were looking for, you said that R&D was the major element. But I wonder if you could quantify or give us some idea of the split between the three areas of developing the pipeline commercialization and the Gen Med pricing headwinds. And within that R&D piece, are we really looking purely at increased spend on -- or are you convinced that you have the right research infrastructure for continued innovation within R&D? And then secondly, on consumer, going back to Florent's question. And in the past, some people have speculated that the timing of those RX-OTC switches would impact the timing of the consumer spend. Is that true? Has that changed? And if there is a question of capturing the upside from those switches, does that impact the pathway that you will take for the divestment of the Consumer business. So potentially, would you consider keeping a stake beyond an initial spin? .

And Simon, JB, the relative weight of the components on the '24 performance of R&D commercial investments, Gen Med pricing and perhaps even tax, which wasn't mentioned. .

Well, tax is 200 bps. So that's well publicized. I would say, on a repeat, the bulb of it is a pipeline. Of course, we have also some other topics around Gen Med, around as a stand-alone cost of consumer health, backing our launches, which are successful, so all of this play a part. But remember, top line growth is untouched. Strong rebound from '25 onwards. On the D versus R, I would say that that's an important point. And of course, it's maybe more an answer for -- but from a financial point of view, in terms of risk appraisal, you've noticed that the bulk of our I&I pipeline is in its D phase and we are going to double down on investing in a pretty high POS portfolio versus just increasing massively just R, so that's an important thing to keep in mind when you look at our risk profile. And regarding the switches, it's not so much a binary piece, but we'll keep in mind, everything you've said today, and it's an interesting feedback, but it's too early to say which we would take.

Thank you -- did you have anything?

Yes. quickly, Simon, thank you for the question. So there's no doubt that we're going to double down on D internally. We're excited about D, including molecules like [indiscernible] and small molecule TNF that Paul has already referred to. But I just want to double underline that actually, we have huge confidence in our early pipeline, both internally, but also our external media activity that will feed the pipeline. You'll have seen today at 7 a.m. ESG announcement from Chimera, one of our partners that the Chimera 474 molecules just gone into Phase II or -- inhibition, but had radenivis separativa So the short answer to your question is while we are confident about our late-stage development pipeline, we remain excited about our own internal and partnered activity, but we will be mindful through the reallocation of spending every dollar wisely. And that's the opportunity I've had when I started. Thank you. .

I think yes, we [indiscernible] just announced. Today, [indiscernible], that's great news. That's another shot on goal we've got as we go into Houman's in HS. Okay. Any other questions?

Yes. Next question is from Seamus Fernandez from Guggenheim.

Thanks for the question. So just two quick ones. Should we basically signal today's announcements as suggesting that you have enough in-house and that you're really investing on the internal side of the business going forward via the recently acquired pipeline or do you have further interest in going externally for deals. We've seen a lot of speculation that Sanofi has been extremely active in potential business development. And I guess the concern here is that, that could also contribute meaningfully to R&D spend should you move towards, especially high plus -- acquisitions that are potentially dilutive to the business. So should we be thinking about that as R&D-oriented deals or potentially accretive deals, if that's where Sanofi's plan? And then the second question is just really I think there's this assumption that you've basically kind of taken the consensus number for earnings down 13% to 15% in 2025. So I think a lot of the questions that folks are fielding right now, are trying to get a sense of the magnitude of that earnings rebound. And just how deep the BOI change is actually going. So if there's any color that you can offer on that, removing 32% doesn't necessarily mean that we're also guaranteeing about 31% or hopeful to achieve better than 30%. So any help there would be fantastic. .

Okay. Well, I think, firstly, on the question on the R&D spend. I think you sort of say is it internal programs or are we made provision, if you like, for to do M&A? I think it's just worth clarifying for everybody that we have as significantly increasing confidence in our own pipeline. We don't carry placeholders for just in case. We are very, very comfortable that we have a lot in our own pipeline that can deliver transformational value creation in the Company period. . But that said, we have to work very hard, like we did with the recent Teva deal on the TL1A or the E.coli deal with Janssen that we have to -- where we want to tuck something in, we have to make a little space for that to get it done. That's discipline. So I think it's also worth being clear because we haven't given a number for '25, yes, we've increased some flexibility for us, but it would be a mistake for people to think that we're not maintaining or increasing discipline. The discipline and to continue to improve the operational efficiency of the Company is an absolute priority. But what we didn't do was dimensionalize it because we want to get on with the work and create the value. So -- and I think you'll see that reveal itself over time, but today is not the day for that. So J.B., is there anything to add on.

I think it's important to repeat that we are keeping intact our capital allocation, of course, provide dividend and so on and so forth, but on the organic growth. And I think we've demonstrated in the last two years, that if we are looking at something opportunistic, it will not be idly dilutive and it has to be very well priced on value generative for shareholders as of day 1. So that's pretty clear. . On the margin, I think it's with a low decline -- a slow decline, a small decline, sorry, in '24 with -- on the flattish without effective tax rate impact, it gives a very clear view what -- from that base, 2025 would be meaningful on a very strong rebound. .

Yes. And that strong rebound. I don't know everybody is would like to see us put a number on it and dimensionalize it. And it's already been mentioned on the call, the 32%, which we guided back in 2019. If you think how far we've come, I think what management is saying fully supported by our Board is that we've earned the right for some flexibility, but it doesn't change our desire to run a more profitable more valuable Company. That simply hasn't changed. What we've done is given ourselves -- we've widened the bookends to create more value. So I think if you think it's freestyle. I just want to correct any misunderstanding about that because that is just simply not the case, if anything, for our leaders in the Company, there is an acute awareness of our ability to demonstrate year-on-year and a more interesting compelling operational story. So that is simply not going away. Recognizing in your world, you can't put that in a model, but you have to understand in my world, I need to create the most value for shareholders and patients that possibly can. And that's why we find ourselves probably saying the same thing without being able to give you a number to reassure you. But you -- we have to know that we're betting on ourselves in this moment. We have a lot of confidence in that. I think maybe we go to the last question. .

Last question from Richard Vosser from JPMorgan.

Two, please. Just on the EUR 500 million target. Maybe you could give us a little bit of color on the -- and the breakdown between Beyfortus -- and Tzield clearly mostly Beyfortus, but some idea there. And then just on Beyfortus. I think in the past, you've talked about 3-year ramp to peak sales. Is that still intact with the supply? Or can we accelerate it if you can get CDMOs to make more of the product? Just some thoughts there. .

So yes, we moved the number on sales from EUR 400 million to EUR 500 million. I think you've seen the...

Greater than.

Thank you, Eva. Greater than. You can't see this, but this is why she sits next to me to remind me of the things that I missed. Greater than EUR 500 million, and I think I'm glad to remind me of that. But you've seen the individual asset sales in Q3, and you can see the weight of them. And this is the magic about these three assets. The Beyfortus number could be very significant. But you go all the way through to Tzield, which at some point over the next year, two years, three years, when screening and everything is done, we'll start to become a big deal for this Company. So their trajectories, I think you alluded to the same part of the question, are not the same shape. So we've not said how we mix it up, but we just want you to know. I said a bit earlier on about how good we are operationally. We're doing that. That's H2 new sales of greater than EUR 500 million. This Company knows how to launch. I think there was some question mark about Dupixent whether there's some rust on the launch machine. There is no rust on launch machine, just to be clear. So we know exactly where we stand. Tom, I think the second part was really around there's time to the ramp to peak because vaccines is very specific as well. And will you be impacted by some precedented demand?

And a great question, John. You're rightfully pointing out to the fact that we said roughly three years or slightly more is about the big sales ramp-up for vaccines with the rate of take. I totally keep that in line. I think we are on a 3-year trajectory for -- so that's definitely concerned. What's new with this level of unprecedented demand and our launching capabilities is that maybe the way we were looking at pixels in the past is now to be updated. So definitely three years in terms of ramp-up, but maybe with a bigger potential in terms of pixels. .

Yes, it's interesting you say that because I think what we've learned -- of course, you'd rather have perfect supply. But what we learned from all the dialogue is the number of parents and even pediatricians recommending or choosing is more than you could possibly have expected, which tells us that the total is going to be very significant indeed. And the shape may have a little bit of give and take in it, but we'll get to a very different number than we imagined at the beginning. [indiscernible] Listen, by way of just closing this out for us, I think it's very important to be clear, and I said this to the Board just a day or two ago that we have reached the point where we believe we can create more value by taking this approach. And we understand there's some short-term disappointment. You want to be able to model, you want to have certainty. The price for certainty for us is not maximizing the long-term value of the Company. So we take it and we carry it. And I have to look at that and I look at the share price reaction. And whilst disappointing on the day, I have to fully understand our work is to get it done, to get to R&D Day to show you why we're excited, to show you what we bet because if you ask me, would I take this situation back in '19 when JB and I were rolling the strategy out. The answer is we would, but we've come a long way, but we still have a long way to go. And so while we have a lot to prove and we'll take it now, we have cost discipline. We believe in the long-term sales growth potential and those two things together with an improving -- of success in R&D and operational alpha on launches means that we can really do something very special here. So I accept that people have [indiscernible] of news, a lot to take in, but doubling down to become a pure-play biopharma and respectfully exiting consumer separating rather at some point is an important part of the sort of obsessive focus on creating value in pharma. That's where we are, it's the first time this Company will be able to be in that situation. So look, we take it what it is today, and we'll show you why it was the right decision. So thank you, everybody, for joining the call. Thank you.