Sanofi SA

PAR:SAN

Earnings Call Analysis

Sanofi Q3 2023: Growth and Innovation

Sanofi's third quarter of 2023 showcased solid performance and strategic execution with strong demand for its Specialty Care products and Vaccines, notably Dupixent's exceptional growth, with sales on track to exceed EUR 11 billion annually. Specialty Care and Vaccines now account for almost two-thirds of total sales, underpinning robust quarter results despite generic competition for Aubagio. The company has increased sales expectations for three innovative medicines to surpass EUR 500 million in the latter half of the year. Flu vaccine sales are projected to be among the highest in Sanofi's history. Year-to-date sales rose by 3.9%, while R&D expenses saw a modest increase of 1.6%, and earnings per share (EPS) improved by 4.9% in the first nine months.

Strategic Transformation and R&D Focus Bear Fruit

Sanofi's 'play-to-win' strategy underscores its progress, specifically in R&D, pivoting towards top-tier or market-first remedies and inoculations. The transformation has led to robust sales growth within Speciality Care and Vaccines segments, substantiated by breakthroughs like Dupixent. With no significant patent cliffs looming until decade's end and promising returns from increasing R&D outlays, the company is on a trajectory of sustained growth. In a striking move to streamline focus, Sanofi plans to split from its Consumer Healthcare business by Q4 of 2024, aiming for greater agility and market adherence.

Specialty Care and Vaccines Drive Growth

The company has witnessed a double-digit surge in Specialty Care, with Dupixent's success and rare diseases treatments making significant contributions. Meanwhile, Vaccines have crossed EUR 3 billion in sales, bolstered by high demands for products like Beyfortus. However, the General Medicines segment faced headwinds, primarily due to price declines and strategic product divestitures. Nonetheless, the robust performance of the growth segments compensated for these challenges, now constituting nearly two-thirds of Sanofi's total sales.

Impressive Launch Uptake and Raised Sales Expectations

Sanofi's new launches have exhibited striking uptake, particularly Altuviiio, securing 40% of U.S. hemophilia A market switches and approval in Japan and Taiwan. Beyfortus is making history with rapid pediatric immunization rates, and Tzield shows promise in slowing Type 1 diabetes progression. Due to these successes, Sanofi anticipates combined sales of these three medicines to exceed EUR 500 million in the second half of 2023. Dupixent maintains its growth trajectory, with Q3 sales topping EUR 2.8 billion and annual sales now exceeding EUR 11 billion.

Collaborations and Agreements Bolster Pipeline

Seeking innovative treatments for large markets with unmet medical needs, Sanofi has engaged in collaborations with Teva and Janssen Pharmaceuticals. Teva's partnership focuses on a novel anti-TL1A therapy that could be a game-changer for inflammatory bowel diseases. At the same time, Janssen's agreement revolves around a candidate vaccine against E. coli, which could be pathbreaking given the bacteria's increasing impact, especially on the aging population.

Financial Performance and Guidance

The financials reflect a 3.9% sales increase credited to products like Dupixent and Sarclisa, while R&D expenditures rose by 1.6%. The operating margin declined slightly to 31.4%, attributed to the loss of exclusivity for Aubagio. Nevertheless, the company forecasts a mid-single-digit EPS growth for full-year 2023 at a constant exchange rate, despite facing currency headwinds estimated at 6% to 7% based on October's averages.

Earnings Call Transcript 2023-Q3

[Eva Schaefer-Jansen, executive]

Good morning, good afternoon, and good evening to everyone. Thank you for joining us to review Sanofi's third quarter 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 involves 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 [Foreign Language] 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 Ongevalle, Global Business Unit Head, Consumer Healthcare. The Global Business Unit heads, Brian Foard, 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.

[Paul Hudson, executive]

Well, thank you, Eva, and thanks to everyone for joining our call today. Before I discuss this quarter's highlights, I want to start by updating you on other announcements we made this morning. We have 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 in Paris. This milestone is a win-win. It allows Sanofi to become a pure-play biopharma company, will 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 until the end of the decade and expected benefits from accelerated investments in R&D.

We will discuss these strategic announcements in more details later on the call, but let me now turn to a brief review of the quarter 3 results that exemplify our successful strategy execution towards sustainable growth from innovative medicines. We delivered another quarter of double-digit growth in Specialty Care, mainly driven by the outstanding success of Dupixent and our performance in rare diseases.

In Vaccines, sales exceeded EUR 3 billion in the quarter, supported by the unprecedented demand for Beyfortus. We continue to lead the influenza vaccines market with our successful differentiation strategy around premium products such as Fluzone High-Dose.

General Medicines sales were lower due to price erosion in most markets, including in the U.S., and we continue to divest nonstrategic products. Our stand-alone consumer health care business continued its positive performance in past quarters.

In summary, the underlying strength of our growth drivers more than offset the expected impact from Aubagio generic entries. As a result of our continued strategic execution, almost 2/3 of sales are now coming from Specialty Care and Vaccines.

Moving to Slide 8, on the impressive uptake of our key launches. Altuviiio is capturing 40% of all the switches in the U.S. hemophilia A market at the end of Q3. And the number of total patients more than doubled versus Q2. During the quarter, Altuviiio was also approved in Japan and Taiwan.

There is tremendous momentum for Beyfortus, which we believe to be one of the fastest uptake of any pediatric immunization ever, and it has resulted in unprecedented demand across the launch regions. Our teams are working round-the-clock in contact with all the stakeholders to secure supply to protect all infants against RSV.

For Tzield, we are making steady progress around patient screening and enrollment in our support program. This month, Phase III data from the PROTECT study was presented at ISPAD in Rotterdam, showing the potential to slow the progression of Stage 3 type 1 diabetes. The full data set was also simultaneously published in the New England Journal of Medicine. We are hopeful to be able to expand Tzield's current label leading also to a significant upside of Tzield's commercial potential.

As a result of the successful sales ramp-up in the quarter, we're raising our sales expectations for these 3 innovative medicines to exceed EUR 500 million combined in the second half of 2023.

With sales of more than EUR 2.8 billion in Q3, Dupixent reported another quarter of impressive growth. The strong brand performance continues to be fueled by demand across all geographies, newly approved indications and demographics. Total sales are now annualizing at more than EUR 11 billion. And we remain very excited about the growth outlook for this unique medicine. As many as 750,000 patients are now benefiting from access to therapy with Dupixent, drawing more than 6 years since its initial launch in AD, Dupixent has set a very high bar for both efficacy and safety, including for patients as young as 6 months. We continue to build on this remarkable body of evidence with the recent inclusion of 5-year atopic dermatitis safety data in the U.S. and EU labels. And we are persistent in our ambition to lead with science to address larger patient populations through label expansion into new indications based on our deep understanding of the type 2 inflammatory pathway with Dupixent.

On Slide 10, we continue to drive growth with our differentiated flu vaccines that now make up more than 70% of the total flu sales. As highlighted during our Q2 call, the flu vaccines market is increasingly competitive, especially for standard dose flu vaccines, coupled with vaccination rates that remain below the pre-pandemic level. Despite these unfavorable market dynamics, we expect to deliver flu sales in 2023 at a level that will be among the top 3 in Sanofi's history. We remain confident in future sales dynamics driven by the demand for vaccines that offer protection against the severe consequences of flu.

Moving to Slide 11. We continue to leverage external innovation building up our leadership in immunology. Earlier this month, we announced a major collaboration with Teva on a novel anti-TL1A therapy with a differentiated target profile. Phase IIb is currently ongoing. And while time will tell if we deliver on the target product profile, we believe this molecule has the potential to be best-in-class treatment to address unmet medical need in a large market of inflammatory bowel diseases.

Similarly, in Vaccines, we entered into an agreement with Janssen Pharmaceuticals earlier this month to develop and commercialize a potential first-in-class candidate against extra intestinal pathogenic E. coli, also known as ExPEC. A large Phase III trial is already ongoing. E. coli is a significant cause of sepsis, mortality and antimicrobial resistance in old adults. As the number of cases is rising in an aging population a novel ExPEC vaccine represents an excellent strategic fit with our portfolio of marketed products and pipeline candidates. We aim to leverage our expertise in vaccines to make this solution available to protect a broad population of seniors above 60 in the future, comparable to the protection of adults against shingles or PCV, for example, today.

I now hand over to Jean-Baptiste for a brief look at the Q3 financials.

[Jean-Baptiste de Chatillon, executive]

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 6 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 Aubagio LOE, our last significant LOE till 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 profit. EPS was up 4.9% during the first 9 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 Aubagio 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 GenMed 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 3 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 CHC 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 [ business ] supported by the recent launches, more than offsetting the Aubagio LOE of the pricing headwinds especially in GenMed, 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.

[Paul Hudson, executive]

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 of best-in-class medicines, and we're building on our core key area 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 GenMed 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 toward 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?

[Houman Ashrafian, executive]

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 4 years and actively we're shaping the discovery and development portfolio.

It's been just over 4 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 amlitelimab, 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 6 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 reachable, thanks to our talented and dedicated international team, many of whom I've had the pleasure of meeting at 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 [Technical Difficulty]. As part of these efforts, leveraging my recent background, tapping external innovation, especially for the early to mid-stage assets will be thoughtfully considered, while ensuring strategic, scientific, and financial rationale remains stacked up.

As you'll see on Slide 19, as we transform and modernize the company for the long term, the teams also keep delivering clinical performance and creating value in the short term. We are extremely proud of the progress we made in immunology with the success of Dupixent and the leadership we've built in type 2 inflammatory disease. We are determined to expand our immunology portfolio beyond type 2 and to drive the innovation by deploying disruptive technologies for the development of first and best-in-class medicines. We continue to reinforce our development organization to drive these programs relentlessly, through executional efficiency.

And as you can see on Slide 20, I'm happy to share with you some of the recent positive data that were delivered at the time that I just arrived. Amlitelimab's positive Phase IIb data recently presented at the EADV Congress where the scientific community has been impressed by both a strong efficacy and safety data. Amlitelimab has a unique nondepleting mechanism of action targeting OX40-Ligand with the potential to restore immune homeostasis with a sustained effect and with infrequent dosing. In this Phase IIb study, amlitelimab showed statistically significant improvements in the primary endpoint, a percentage change in Eczema Area and Severity Index, otherwise known as EASI, score at weeks 16 and 24 as well as clinically meaningful, a nominally significant improvement across all key secondary endpoints at week 16 and notably, maintained at 24 weeks.

As indicated in this slide, 45% of patients treated with amlitelimab, 250 milligrams with a loading dose achieved IGA 0/1 at 24 weeks. These strong efficacy results, combined with a reassuring safety profile improve our confidence in amlitelimab's potentially best-in-class profile for the treatment of AD, providing a signal to pursue a differentiated dosing regimen that could be very meaningful to patients with moderate to severe atopic dermatitis. These data from the -- form the basis for our advancement into Phase III clinical development, which we expect to begin in the first half of 2024.

Slide 21. As you can see, the company has made tremendous progress with its R&D transformation over the past 2 years -- over the past few years. Clearly, we have now arrived at a point where our innovative pipeline requires increased funding to fully exploit the potential of these transformative assets and to make them available to patients as soon as possible. We look forward to sharing more of our excitement by the recent flow of positive pipeline environment at the upcoming R&D Day on December 7.

And with that, back to you, Paul.

[Paul Hudson, executive]

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 it remained fully integrated into the former organization. You could say like prioritization, consumer centricity, and kept performing below the market. Our decision to create a stand-alone unit 4 years ago enabled CHC 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-led.

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 4 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.

[Julie Van Ongevalle, executive]

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 age, 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 3 positions, of which most are holding #1 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 3 years.

Important to note is that we're successfully operating in the attractive EUR 200 billion OTC and VMS 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 90% 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.

[Jean-Baptiste de Chatillon, executive]

Thank you, Julie. On Slide 26, let me remind you of our success in delivering on our financial objectives during the first chapter of Play to Win, 10 consecutive quarters of growth, 540 bps BOI margin improvement and 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 employing insights from AI and predictive analytics across the organization.

Today, Sanofi also benefits from a greatly improved cash flow generation. In December of 2019, we outlined our capital allocation policy and have demonstrated discipline in executing on those priorities, investment into organic growth through our pipeline, and growth drivers remains our #1 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 reallocate spending from completed Phase III programs such as tolebrutinib under COPD programs to new programs either internally derived or from business development.

The simplification and streamlining of the GenMed portfolio continue at pace. We reached the target number of around 100 branded product families this year, 2 years earlier than initially guided at our Capital Markets Day in December 2019.

More than EUR 1.9 billion of cash proceeds were generated. Due to continued pricing headwinds across the portfolio of other products and increased competition in the heparin market, we will no longer aim to stabilize GenMed sales in 2025 at the 2020 level, but instead, we'll continue to reduce the portfolio to around 85 branded product families, thus allowing for further efficiencies.

On Slide 30, we are launching efficiency initiatives, targeting up to EUR 2 billion savings across Sanofi to free up operational resources and support the accelerated R&D investments. We will be prioritizing our oncology R&D program and focus on those with first or best-in-class potential, reallocating resources on growth drivers and strategic TAs. We will also leverage procurement to generate additional savings.

Lastly, we will modernize the commercial delivery by optimizing our country setup, expanding the hub strategy to increase centralization, while refocusing R&D on most critical sites on technology platforms.

On Slide 31, we are providing a first outlook for '24 and '25. For '24 and '25, we expect continued sales growth supported by our leading franchise on launches for Dupixent based on the strong double-digit growth rate that we report again today. We expect sales to reach close to EUR 13 billion in 2024. Vaccine sales are expected to grow mid- to high single digit in both years as per our prior guidance.

On the P&L side, OpEx is expected to grow in 2024 due to a step-up in R&D investments. Capital gains from product divestments are expected at a similar level as in 2023. Due to changes to global tax regulation, the company's effective tax rate is expected to increase to 21%.

Looking further out into 2025, we expect to see the full benefit from the reallocation of our planned efficiencies initiative on a relatively stable R&D expenses year-on-year as several large Phase III trials in MS and COPD will mature over the period.

As a result, business EPS in 2024 is expected to decline low single digit at constant exchange rate or remain roughly stable, excluding the impact of the expected tax rate change, followed by a strong business EPS rebound in 2025.

So Paul, back to you to conclude.

[Paul Hudson, executive]

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 a 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 3 to 5 products to market, with EUR 2 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.

[Eva Schaefer-Jansen, executive]

As a reminder, we would like to ask you to limit your questions to 2 each. You have the 2 options to participate, option 1, click the Raise Hand icon at the bottom of your screen. You will be notified when your line is open to ask your question. And at that time, please make sure you unmute your microphone.

Our option 2, submit your question by clicking the Q&A icon at the bottom of the screen and your question will be read out by our panelists.

[Operator]

The first question will be from Luisa Hector from Berenberg.

[Luisa Hector, analyst]

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 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.

[Paul Hudson, executive]

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

[Jean-Baptiste de Chatillon, executive]

Yes. I guess the question is why now on -- it's 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 readouts 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 GenMed -- from GenMed were not being reversed.

So those option 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.

[Paul Hudson, executive]

And I'll come to you, Houman in a second. And of course, we come off the back of things like amlitelimab, EADV, it's Houman 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 set 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 on confidence as well why do we believe it will be more successful?

[Houman Ashrafian, executive]

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 [ Ex com ] 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 -- 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.

[Paul Hudson, executive]

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.

[Houman Ashrafian, executive]

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.

[Paul Hudson, executive]

Yes. And I think before I -- I'll throw it to Brian on Dupixent in a second, but also, I think it might be worth recognizing although you know, 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 his background.

And it's unique, and I think that's already pudding 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 spend -- investments Brian? EUR 13 billion and how confident are you on the formulary status.

[Brian Foard, executive]

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 actually, as we talk about the confidence, not only with the payers, but the confidence 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 6 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 it would 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 waypoint 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 -- waypoint of a little bit greater than EUR 13 billion. And now here we are talking about again 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.

[Paul Hudson, executive]

Thank you, Brian. Maybe just add then finally to that. With our delivery on Beyfortus and Altuviiio, the great work that's been then to prepare ourselves for Tzield and the delivery 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.

[Operator]

Next question is from Emily Field from Barclays.

[Emily Field, analyst]

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 amlitelimab and Frexalimab going into Phase III. So are these studies going to be larger than initially planned?

And then second question, just on GenMed, 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.

[Paul Hudson, executive]

Okay. Maybe just a quick response from me. We'll go through this at R&D Day. I understand that why you asked the question. Going more broadly with amlitelimab, potentially going more broadly with rilzabrutinib, 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 margin -- you go, you know what, if we like the data, we're going to have to run parallel studies to bring this in 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 too 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 are 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 GenMed?

[Olivier Charmeil, executive]

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 100 in 2025 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 GenMed sales into 2025 at the level of 2020. But we remain very, very committed to our guidance in terms of BOI margin between 2020 and 2025 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.

[Operator]

Next question is from Peter Welford from Jefferies.

[Peter Welford, analyst]

First question, I guess, it's coming back to a point you to some extent, already covered, but I guess just curious why the decision now to get to talk about 2024, 2025 EPS and highlight the increasing R&D.

I guess we would never in the outside world have known the increase in R&D plans until potentially the 7th of December R&D Day. So want to just highlight to you, why you disclosed that -- the spendings sort of now, but then give the details on the 7th of December. What was the urgency, I guess, in this sort of 6 weeks, if you like, preview rather than to certainly giving us all the information together then at the Capital Markets event.

And then just secondly, if you just come back to GenMed. Obviously, you've done the Tzield deal. I mean you've actually upgraded the sales outlook for the product portfolio of newly launched brands. We've also seen Rezurock 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? And appreciate then on the stabilizing business -- we think 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?

[Paul Hudson, executive]

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?

[Jean-Baptiste de Chatillon, executive]

Yes. Well, that's a good 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 deferring.

Then on 2025, it's all pull and pushes 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 Houman, with great speed, 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 or vaccine pipeline as I said. So this is one point. On COGS and Dupit, remember, I said, 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.

[Paul Hudson, executive]

Thank you, JB. Okay. To GenMed, I'll throw it to you, Olivier for a second, but just the general context, I think you know this, I think you said it. Your pricing your 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 -- that's the post pandemic sort of fiscal deficit -- attention. I think we've coped very well, but it won't offset.

For Tzield and Rezurock and the sort of growth profile of the segment at the core, if you like, of GenMed, Olivier?

[Olivier Charmeil, executive]

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 Rezurock. 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 [ Tzield ]. And of course, [tolebrutinib] 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 ISPAD. I've met lot of key opinion leaders on Tzield, I was with Paul. And we are really happy, we are in line now with what we had initially planned in the U.S., and 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 when they get infused. Now 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.

[Operator]

Next question is from Graham Parry from BofA.

[Graham Parry, analyst]

So first one is just I think clearly, the series of announcements this morning caught the market off-guard. We see them, 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 thought 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 earnings and the 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, I think in that some sort of communication grow -- to 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 are 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.

[Paul Hudson, executive]

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

[Jean-Baptiste de Chatillon, executive]

Well, I think Graham, 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, 3 to 5 launches of assets with EUR 2 billion to EUR 5 billion peak sales potential. .

And that's very important today to remind just 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 Beyfortus -- you want to talk about -- but, should I say something about CHC .

[Paul Hudson, executive]

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

[Jean-Baptiste de Chatillon, executive]

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 flat 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 rebound as soon as 2025 with the growth profile, which is untouched. CHC, 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.

[Operator]

Next question is from Tim Anderson from Wolfe .

[Timothy Anderson, analyst]

I just want to, again, stay on the guidance. How much of the pressure to earnings in '24 and '25 is from below the line items versus on the revenue side. You're talking about GenMed 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.

[Paul Hudson, executive]

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

[Jean-Baptiste de Chatillon, executive]

I think it was amazing -- everything which is below the top line, if I understood well?

[Paul Hudson, executive]

Yes.

[Jean-Baptiste de Chatillon, executive]

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 main difference is really R&D. Of course, it's altered by the shape of the decrease in GenMed. 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 2 big deals appearing, the one on TLA1, which is a great complement to our immunology story and also in vaccine, the E. Coli, Paul, just presented. There are big potential. So in this endeavor to look for [ EUR 3 billion to EUR 5 billion -- EUR 2 billion to EUR 5 billion ] peak sales. That's where we are. It's R&D, the main driver of the change.

[Eva Schaefer-Jansen, executive]

The tax regulation changes?

[Jean-Baptiste de Chatillon, executive]

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. Yes. That's the way it is.

[Operator]

Next question from Peter Verdult from Citi.

[Peter Verdult, analyst]

Yes. Pete Verdult, Citi. I wanted to talk more about the pipeline, but I'll probably have to wait for December, given the share price reaction. So apologies team. It's 2 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, Paul or JB, Beyfortus in September at the launch, the message was capacities are great. The demand has been phenomenal. Shortages are now being reported. So I just want to gauge how quickly you can ramp the capacities further near term, given the maybe analog benchmarks, you're using are clearly sort of undercooking. What's happening in reality.

[Paul Hudson, executive]

Thank you, Pete. 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.

[Jean-Baptiste de Chatillon, executive]

We're not guiding, but our confidence, I think you can feel it through 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 on Beyfortus?

[Paul Hudson, executive]

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

[Thomas Triomphe, executive]

Thank you very much, Pete. Great question. Yes, absolutely, we are very happy about the launch of Beyfortus. 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 for the product.

What does it mean really? 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 number of it 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 partnership. 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.

[Paul Hudson, executive]

Thank you, Thomas. 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.

[Operator]

Next question from David Risinger from Leerink.

[David Risinger, analyst]

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.

[Paul Hudson, executive]

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 in TA looks...

[Jean-Baptiste de Chatillon, executive]

I think being a...

[David Risinger, analyst]

Well, sorry to -- 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.

[Paul Hudson, executive]

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 amlitelimab, incremental biologics. Of course, Dupixent 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 it efficiently.

In the business itself, and I think Olivier touched a little bit on this. He's got the launches on 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 GenMed team have done. More than -- or close to 9,000 people have left GenMed over the past 2 or 3 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.

[Operator]

Next question is from Gary Steventon from Exane BNP.

[Paul Hudson, executive]

We lost Gary?

[Operator]

He's with the phone so maybe. Next question is from Florent Cespedes from Societe Generale.

[Florent Cespedes, analyst]

Can you hear me?

[Paul Hudson, executive]

Yes. We got you.

[Florent Cespedes, analyst]

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 a risk to OTC switch, the 2 projects on Tamiflu and Cialis. If you will be ready to, let's say, file next year or in 2025? Where are the clinical trials ongoing, please? .

[Paul Hudson, executive]

JB, a question about '25 and then also onwards. Do you think we'll improve our operating efficiency. I think that was the question? In 2025 and beyond.

[Jean-Baptiste de Chatillon, executive]

Yes. I think you have seen in our deck on our presentation that we have released 3 buckets, and it's a second major step in the simplification and restructuring of the company to make it leaner. We are -- since 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 Florent. 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.

[Paul Hudson, executive]

Julie, on switches. .

[Julie Van Ongevalle, executive]

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 important 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.

[Paul Hudson, executive]

Yes. I think that there's still a great path forward...

[Julie Van Ongevalle, executive]

Yes.

[Paul Hudson, executive]

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 we'll 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.

[Operator]

Next question is from Simon Baker from Redburn.

[Simon Baker, analyst]

Two, if I may, which 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 3 areas of developing the pipeline, commercialization and the GenMed pricing headwinds. And within that R&D piece, are we really looking purely at increased spend on [ D ] -- 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 spend?

[Paul Hudson, executive]

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

[Jean-Baptiste de Chatillon, executive]

Well, tax is 200 bps. So that's well publicized. I would say, on a repeat, so bulk of it is a pipeline. Of course, we have also some other topics around GenMed, around as a stand-alone cost of consumer health, backing our launches, which are successful, so all of this will 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 Houman -- 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 the 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 route we would take.

[Paul Hudson, executive]

Houman, did you have anything to add?

[Houman Ashrafian, executive]

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 amlitelimab 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 BD activity that will feed the pipeline. You'll have seen today at 7 a.m. EST announcement from Kymera, one of our partners that the Kymera 474 molecules just gone into Phase II IRAK4 inhibition for Hidradenitis Suppurativa.

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 and spending every dollar wisely. And that's the opportunity I've had when I started this.

[Paul Hudson, executive]

I think yes, with -- IRAK4 they've just announced. Today, Kymera. That's great news. That's another shot on goal we've got as we go into humans in HS. Okay. Any other questions?

[Operator]

Yes. Next question is from Seamus Fernandez from Guggenheim.

[Seamus Fernandez, analyst]

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-cost I&I 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 playing?

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 from 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.

[Paul Hudson, executive]

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 -- 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 JB, is there anything to add on '25.

[Jean-Baptiste de Chatillon, executive]

I think it's important to repeat that we are keeping intact our capital allocation, of course, provisional 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 which is -- from that base, 2025 would be a meaningful on a very strong rebound.

[Paul Hudson, executive]

Yes. And that strong rebound. I 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 I 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.

[Operator]

Last question from Richard Vosser from JPMorgan.

[Richard Vosser, analyst]

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, Altuviiio 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.

[Paul Hudson, executive]

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

[Eva Schaefer-Jansen, executive]

Greater than.

[Paul Hudson, executive]

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 miss.

Greater than EUR 500 million, and I think I'm glad you reminded me of that. You've seen the 3 -- you've seen the individual asset sales in Q3, and you can see the weight of them. And this is the magic about these 3 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, 2 years, 3 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 the 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?

[Thomas Triomphe, executive]

No, great question, Richard. And you're rightfully pointing out to the fact that we said roughly 3 years or slightly more is about the peak sales ramp-up for vaccines with the rate uptake. I totally keep that in line. I think we are on a 3-year trajectory for peak sales. So that's definitely confirmed.

What's new with this level of unprecedented demand and our launching capabilities is that, maybe the way we were looking at peak sales in the past is now to be updated. So definitely 3 years in terms of ramp-up, but maybe with a bigger potential in terms of peak sales.

[Paul Hudson, executive]

Yes, it's interesting you said it out because I think what we've learned -- of course, you 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. I think that's fair, right?

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 proven probability 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 said this all, 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. And 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.