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Sanofi SA
Earnings Call Analysis
Q3-2024 Analysis
Sanofi SA
In Q3 2024, Sanofi reported sales of EUR 13.4 billion, reflecting a solid growth of 16% at constant exchange rates. This growth is underpinned by the strength of their portfolio, with sales growth estimated at approximately 11% when excluding phasing effects from the flu season and other factors. Dupixent continues to be a key driver, generating nearly EUR 3.5 billion in revenue, marking its significant contribution as it maintains a leading position in the new-to-brand prescription market share in the U.S. and approaches blockbuster status outside of the U.S.
Sanofi's vaccines business grew impressively by 26% in the quarter, assisted by phasing benefits and the successful launch of Beyfortus, which contributed EUR 645 million in Q3 alone. The company has now realized a cumulative sales of nearly EUR 3 billion from its recent pharmaceutical launches, highlighting an exceptional growth profile. These newly launched medicines, alongside Beyfortus, are pivotal for Sanofi's acceleration in revenue growth.
The company raised its business earnings per share (EPS) guidance for 2024, predicting a growth of at least a low single-digit percentage at constant exchange rates. This is a notable change from previous guidance, which expected flat growth. The increase is attributed to the strong performance observed over the past two quarters, further bolstered by initiatives to control operating costs. Gross margin improved by one percentage point, reflecting positive mix effects despite currency challenges.
Looking ahead, Sanofi anticipates continued solid year-on-year growth, although at a lower pace than Q3. For Q4, Beyfortus is expected to maintain Q3 sales levels at around EUR 1.5 billion for the year 2024. However, due to one-off COVID revenues in the previous year, sales are expected to decline slightly. Overall, the total vaccines franchise is projected to grow by a high single-digit percentage, while the insulin product line, particularly Lantus, continues to stabilize.
Sanofi announced exclusive negotiations to sell a controlling stake in Opella, expecting net proceeds in the high single-digit billions by Q2 2025. This strategic move is expected to enhance value for shareholders by offloading a segment that isn't central to Sanofi’s operations as it pivots towards being a pure-play biopharma company. This transaction is projected to close by mid-2025, with an attractive valuation set at EUR 16 billion and a multiple of 14x estimated 2024 EBITDA. Proceeds will be reinvested following Sanofi's capital allocation policy.
Sanofi remains optimistic about its pipeline, particularly with Dupixent, which is expanding into new indications like COPD, supported by recent approvals in the U.S. and China. The company is aiming for substantial revenue associated with Dupixent, with a targeted sales figure of EUR 13 billion for the full year 2024. Management is confident that Dupixent could achieve a compounded annual growth rate in the low double digits through 2030, amidst potential growth in new indications and geographic expansion.
As part of ongoing efforts to innovate, Sanofi has committed to increasing research and development costs by around EUR 700 million in 2024. This mirrors a growing focus on creating new therapeutics, backing the portfolio that continues to register significant sales growth. The ongoing investment strategy supports Sanofi’s ambition to improve both growth and margin profiles without sacrificing operational efficiency.
With the introduction of new competitors in the market, Sanofi is aware of the potential pressures on pricing and market share, particularly within the respiratory medication sector. However, management believes that the company’s existing frameworks and innovative medicines, such as Beyfortus and Dupixent, coupled with a strong safety profile, will sustain competitive advantages despite the evolving landscape.
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Welcome to the Q3 2024 conference call for investors and analysts. As usual, you can find the slides on sanofi.com.
Please turn to Slide #3. Here, we have the usual forward-looking statements. We would like to remind you that information presented in this call contains forward-looking statements which are subject to substantial risks and uncertainties that may cause actual results to differ materially. We encourage you to read the disclaimer in our slide presentation. In addition, we refer you to our Form 20-F on file with the U.S. SEC and our French registration document for a description of these risk factors.
As usual, we'll be making comments on our performance using constant exchange rates and other non-IFRS measures. Numbers used are million euros and for Q3 2024 unless stated otherwise.
Please turn to Slide #4. First, we have a presentation, then we'll take your questions. As last time, we kept the presentation on the shorter side to allow for more questions, and we aim at keeping the call to about 1 hour.
For Q&A, we have Brian, Olivier, Thomas and Julie to cover the global business; and Roy, our General Counsel. [Operator Instructions]
With this, I'll now hand you over to Paul.
Thank you, Thomas. Nicely done. Thank you, and hello, everyone on the call.
We reaffirmed strong sales performance this year. The total of Q3 sales of EUR 13.4 billion, a 16% increase at CER and an estimated 11% excluding the impact of phasing. This robust double-digit growth illustrates the underlying strength of our portfolio.
Dupixent continued to be driven by global volume growth across all indications and geographies, now reaching close to EUR 3.5 billion in the quarter.
Our vaccines business grew 26%. This increase benefited from an element of phasing in flu and Beyfortus sales. However, the global rollout of Beyfortus provided a strong contribution as well.
Our pharma launches have been performing very well with a 67% increase in sales. This is a result of strong performance across all 8 medicines that we have recently launched and a clear illustration of the value these medicines bring to health care systems and patients.
Opella's 8% growth was predominantly driven by the strategic acquisition of Qunol in the U.S., which has bolstered our presence in the consumer health care market.
That is why, with confidence, that we have once again raised our business EPS guidance for 2024 on Monday. This reflects our continued momentum and our commitment to delivering value to our stakeholders.
On Slide 6. Dupixent delivered another quarter of strong growth. It also reached a major milestone of improving the lives of more than 1 million patients currently on treatment around the world across approved indications, age groups and geographies. Dupixent continues to hold the #1 new-to-brand prescription market share across all its approved indications in the U.S. Outside the U.S., Dupixent is now approaching blockbuster status in a single quarter. This remarkable performance reinforces our confidence in our sales ambition of around EUR 13 billion for the full year 2024.
The recent consecutive approvals of the COPD indication in the U.S. and China on the heels of the EU approval 4 months ago speaks volumes of our ability to move decisively, execute and meet the need for more treatment options. The expansion of Dupixent COPD will give hundreds of thousands of additional patients who are living with this devastating disease the chance to potentially improve breathing and a life with fewer exacerbations. Additional positive Phase III readouts in bullous pemphigoid and chronic spontaneous urticaria will also, if approved, create additional near-term growth opportunities.
Turning to Slide 7. We will continue to execute on the 3 commercial levers that will propel Dupixent's volume demand and its growth longer term. First, the steady increase in the penetration of advanced therapies within the biologic-eligible patient population. New market entrants of other biologics are expected to help drive market growth through improved awareness and adoption.
Second, the geographic expansion with around 30 potential country launches across existing indications by 2026.
Third, the expansion into new indications with high unmet need for large biologic-eligible patient populations, like COPD and CSU. Specifically in the U.S. market, we continue to strengthen patient access to support new indication expansion, including COPD and other new indications, and expand access across both commercial and government channels.
We remain excited by the opportunities ahead of us and in the strong growth outlook for Dupixent, for which we continue to target a low double-digit sales increase -- at CAGR between 2023 and 2030 at constant exchange rate.
Now on Slide 8. Our strong growth in the quarter was accelerated by the outstanding performance of our newly launched medicines. With almost EUR 3 billion in the first 9 months, our launches have become significant contributors to Sanofi's accelerated top line growth profile.
Beyfortus leads the way with sales of EUR 645 million in Q3, a showing an exceptional market uptake in its second season and underscoring the critical role that it plays in All Infant Protection.
With sales of EUR 172 million, Altuviiio further established its position as the new high-efficacy standard of care in hemophilia A treatment, demonstrated by patient switches from other factor and nonfactor medicines.
Other innovative medicines like Nexviazyme, Rezurock and Sarclisa continued to perform well and are contributing to a total of EUR 1.4 billion in sales for this quarter alone. These results show the power of our launch engine and how, with the right focus and sharp execution, we are increasingly delivering transformative treatments to patients around the world.
Moving to Slide 9. Our leading respiratory vaccines, Beyfortus and Fluzone High-Dose, have established new standards of efficacy. Beginning with Beyfortus on the left side, we continue to build an outstanding body of evidence to further strengthen our position as a market leader in All Infant Protection.
A recent study demonstrates that Beyfortus continues to protect infants against RSV hospitalization over a full 6-month duration without waning efficacy. Furthermore, in the U.S., real-world evidence showed an 87% efficacy and reduction of hospitalization rates. This reinforces the real-world effectiveness that Beyfortus has consistently showed with more than an 80% hospitalization reduction in over 75,000 infants.
Importantly, we've been able to secure supply to extend protection against RSV to millions of infants in about 20 countries where Beyfortus is currently launched.
To summarize, we are on a way to making Beyfortus our next blockbuster, thanks to its unique ability to provide All Infant Protection.
Transitioning to influenza. We are glad to see that regulators have increased their focus on the quality of studies supporting the efficacy of flu vaccines by requiring large-scale randomized controlled trials against standard dose. As a reminder, this is what we have done for Fluzone High-Dose, the only vaccine that has demonstrated statistically superiority to standard dose with a 24% superior efficacy in a randomized controlled trial with 32,000 participants. In contrast, the adjuvanted and mRNA flu vaccines of other companies still must pass that high bar with their ongoing studies.
On my last slide, let me conclude with how we advance our ESG commitments in and beyond the workplace. As a responsible employer across the world, we're committed to ensuring a living wage for all our employees. This is why we've adopted the recognized standard of the Fair Wage Network, which guarantees wages above local benchmarks. And going beyond our workforce, our commitment extends to our key supply chain partners. By taking direct responsibility for our employees and partners, we are improving employee well-being and strengthening local economies.
As always, when it comes to our commitment to society and our industry leadership, we hope that others will follow and help set new standards.
With that, I now hand over to François, our CFO.
Thank you, Paul. Good morning, and good afternoon to all. Before I start, let me clarify that financials for this quarter include Opella operations.
Now let me discuss our strong sales momentum. Our top line growth was strong at 15.7% in Q3 at constant exchange rates with sales reaching EUR 13.4 billion. This performance was partially supported by the early shipments in the flu season and Beyfortus strong momentum. Excluding this phasing benefit, we still achieved an underlying double-digit growth estimated to be around 11%, similar to what we achieved in Q2.
Our solid growth in Q3 was broad-based across businesses and geographies. The strategic decisions we have made across our business units are delivering attractive results and give us confidence to continue delivering strong performance in the coming quarters.
Now moving to the group P&L. Gross margin improved by a full percentage point in the quarter, driven by positive mix effects, partly offset by currency impacts and the Aubagio loss of exclusivity.
Higher R&D expenses are in line with our committed increase for 2024, reflecting our continued investment in innovation. SG&A grew substantially less than sales, underscoring our focus on operational efficiency.
Business operating income saw a significant increase of 19.9% in the quarter, primarily driven by higher gross profit and operating leverage. Our business EPS increased by 17.6% in Q3.
Previewing our business outlook for Q4. We expect continued solid year-on-year growth, although at a lower level than in Q3. Do remember that there is 1 less invoicing day in the U.S. in Q4 versus Q3.
Beyfortus Q4 sales are projected to be in line with their Q3 level, supported by the approved additional industrial capacity. We expect Beyfortus sales to reach around EUR 1.5 billion in 2024, a remarkable performance in its first full year of marketing.
For Q4, please remember that we had around EUR 400 million of one-off COVID revenues in Q4 2023 as well as the associated margin. We confirm our full year guidance to increase R&D costs by around EUR 700 million this year, and we will also marginally increase our investment in sales and marketing to support sales growth with a specific focus on digital investments.
For the full year 2024, we expect flu sales to decline by a low single-digit percentage due to a soft vaccination rate while we continue to gain market share. The total vaccines franchise is now expected to grow by a high single-digit percentage. Our insulin franchise, more specifically Lantus, is very resilient, and sales are stabilizing. We expect divestments to reduce sales by about EUR 300 million in 2024. And we anticipate capital gains from divestments to be around EUR 400 million in biopharma only.
Gross margin is expected to decline slightly in Q4 and for the full year due to one-offs last year, such as COVID revenues and Aubagio sales.
As disclosed earlier this week, we upgraded our guidance with 2024 business EPS expected now to grow by at least a low single-digit percentage at constant exchange rates from previously around flat. This reflects a strong business performance over the last 2 quarters, and this reflects our confidence in our [indiscernible].
Turning now to Opella. This transaction marks an important strategic step for Sanofi to become a pure-play and science-focused biopharma leader. On Monday, we announced that we entered exclusive negotiations with CD&R to sell a controlling stake of Opella. Sanofi will keep a significant stake in the company to support Opella in their independence journey and to retain part of their future value creation.
We eventually selected the private option, namely partnering with a world-class PE firm, as it creates the highest value for our shareholders. The valuation at EUR 16 billion EV is very attractive. The 14x 2024 estimated EBITDA is equivalent to the trading multiples of industry peers. We expect the transaction to close in the second quarter of 2025 at the earliest. The expected proceeds from these sales will be redeployed in accordance with our capital allocation policy, ensuring we continue to invest in growth assets and deliver value to our shareholders.
Regarding share repurchases. We are fully aware of shareholders' expectations, and we will provide more specific details as we get closer to the receipt of the cash proceeds. On the other hand, we always look at external growth opportunities to complement our attractive pipeline. We are more thinking of bolt-on acquisitions, and we are not working on any large acquisitions, as evidenced by our willingness to maintain our current strong credit rating, basically AA -- and A1 now, almost AA. We will also consider how to inform investors and analysts in the future about the business performance of Opella as this will be a significant investment on our balance sheet.
That concludes my presentation. I now hand over to Houman for further positive news on the pipeline.
Thanks, François. We've achieved several milestones this quarter, showing our continued strong pace of delivery. Dupixent is now approved for COPD in more than 30 countries, including the U.S. and China, where COPD is a huge unmet medical need due to widespread smoking in the local population.
Another great milestone is the approval of Sarclisa in the U.S. for adult patients with newly diagnosed multiple myeloma ineligible for transplantation. It's the first anti-CD38 with this data in this setting.
Finally, we've shared several positive Phase III readouts, including tolebrutinib, one of our BTK inhibitors which is notable for its effect on disability improvement in MS. Business development, including strategic investments in external innovation, is a well-integrated part of the Sanofi efforts to continually access promising scientific developments and to replenish our pipeline.
We invested in MeiraGTx with high interest in their technology within immunology and neurology. We've invested in Ventyx, focused on autoimmune and inflammatory disorders with an NLRP3 inhibitor in Phase II.
Another biotech company that piqued our interest focused on immunology, was an Anaptys Bio with its potential best-in-class Phase IIb PD-1 agonist tested RA and UC; and in Vicore, with our potential best-in-class Phase IIb angiotensin II type 2 receptor agonist in IPF.
Lastly, we completed a licensing agreement with RadioMedix and Orano Med for AlphaMedix, a best-in-class radioligand based on alpha-emitting isotopes for rare cancers.
We will keep you updated as we continue to access a still optionality for our pipeline and complement the work we're doing internally in research.
On the next slide, last month at the ECTRIMS conference, and presented tolebrutinib's Phase III data in RMS and nrSPMS. We didn't meet the primary endpoint in the relapsing multiple sclerosis study. However, pooled analysis of 6-month data to CDW, this key secondary endpoint, showed a considerable delay in time to onset, which supported the impressive results in non-relapsing secondary progressive, SPMS.
In SPMS, tolebrutinib delayed the onset -- delayed the time to onset of 6-month CDP back 31% with further analysis secondary endpoints showing that the number of participants who experienced confirmed disability improvement increased by nearly twofold through a significant effect on the lowering of the annualized rate of new or enlarging T2 lesions compared to placebo.
Liver enzyme elevations are common to the BTKI class. In our studies, most cases resulted without sequelae. They all occurred in the 90 days. Accordingly, we focused our intense liver monitoring in that period. I'm confident in tolebrutinib for SPMS patients, which could offer a first option where no effective treatment helping improve disability has yet been approved.
Turning to amlitelimab, our OX40-Ligand inhibitor molecule. We recently presented new Phase IIb atopic dermatitis data from the 68-week STREAM-AD study at the EADV conference. The study had 3 parts. The first one was the primary endpoint, a percent of change in EASI, was met at 16 weeks; followed by a second part for 28 weeks, where most patients saw a durability of clinical response after withdrawal at 24 weeks; and the safety follow up at 16 weeks.
Throughout the 68 weeks, amlitelimab demonstrated a pleasing safety profile with most patients reporting TEAEs which were very mild or moderate in severity, and none led to discontinuation of the treatment, emphasizing the differentiated safety profile complementing its confirmed efficacy.
Durability was demonstrated with a sustained percentage of EASI change after amlitelimab cessation. Potential dosing interval of up to 12 weeks with the potential for disease modification and therapy-free remission, not seen with any current medicine, is ambitioned. All Phase III studies in the OCEANA program are ongoing. Readouts are planned in 2026.
The objective of the next slide is to present our work in immunology to the community, where we present the breadth of our immunology portfolio, where we persist with innovation to serve patients' needs. We're increasingly focused across all stages and grades of diseases and patients we serve which are being addressed by approved in-development medicines.
Each of these diseases have distinct characteristics leading to the informed use of our medicines in the specific progression stage of disorders. Increasing options can only be beneficial to patients in areas where there is still significant unmet need.
I'd like to conclude with my signature slide displaying our 18-month news flow, which continues to evolve, and highlights the exciting progress supporting our increased R&D productivity that keeps on delivering. We plan 6 Phase III readouts, 11 submissions and 10 regulatory positions in multiple countries, and we look forward to keeping you updated on progress.
We are humble in the face of disease, and regrettably, not everything will work. But I am optimistic about this unique pipeline and our core focused therapeutic areas carriers in the service of patients.
Before handing back to Paul, I would like to extend a warm welcome to our new Head of Research, Michael Quigley. I'm eagerly anticipating our future collaboration and confident that his expertise will contribute to our continued efforts to enhance our R&D productivity and the quality of our pipeline over time.
With this, I hand back to Paul for Q&A.
Well, thank you, Houman. We'll now have the call to your questions. [Operator Instructions]
Now we take the first question, please. Go ahead.
First question from Richard Vosser from JPMorgan.
Hopefully you can hear me. It's Richard Vosser from JPMorgan. Two questions, please.
First question on Beyfortus. How are you thinking about the commercial potential beyond this season following the ACIP meeting discussing the Merck clesvorimab, I can never say it, data this year? Just to continue with that.
And then second question is just on the Opella deal. How should we think about the high single-digit billion proceeds? How much of that would be realized by debt pass-through from -- pass-down to Opella?
Thank you, Richard, Beyfortus is very easy to say. Thomas?
No, I can't say the other one, either. Thanks for the question, Richard. A very good point, indeed. A few first point to start with. First of all, there's still a lot to go with the monoclonal antibody penetration. So we really welcome that there is more players to come because it will increase the size of the play field, basically.
What is very important is that monoclonal antibodies have shown they are the only pathway to be able to really protect all infants. And if we are 2, we'll be more than 1 to actually sing that song and make sure that more and more babies get protected [indiscernible].
Now in terms of the ACIP presentation, as you were pointing out, too, they were showing still some important differences between the 2 products. It's still early data for our competitor. We've seen just some data, not all of it. We're very confident in the data that we have demonstrated in both our Phase III and our real world evidence data, be it in actual efficacy, or in its pristine safety, or the duration of protection.
So looking forward, and I'm sure we'll have many opportunities, we'll be able to show the differences between the 2 products.
François, Opella deal and proceeds?
Yes. So on the Opella deal, indeed, I confirm that we expect to receive at the earliest in Q4 2025 the high single-digit number in billions of euros. Once again, not earlier than Q2.
Just one small comment on the amount. It's equivalent to the disposal of slightly more than 50% stake in the company. We will get the benefit of the debt push down because, obviously, the company will be fairly highly leveraged. Minus, we need to pay taxes, and there are some transaction costs as well.
The cash proceeds, so we don't expect to get them, the earliest in Q2. So it's a little bit early to talk about that. Obviously, we -- the use will be fully in line with our capital allocation policy. It is essentially around investing in our business, which is already what we do.
On the M&A side, we keep on looking at opportunities in the market. We are talking essentially on bolt-on acquisitions. We are not talking of large acquisitions, as evidenced by the fact that we gave some assurance on our intention to retain AA rating. We will maintain our dividend policy to increase our dividend in absolute value in euro, as we have always done -- already done over the last 30 years. And we will obviously look at anti-dilutive share buybacks.
We heard loud and clear our shareholder expectation regarding share repurchases, so -- which is something that we have discussed in the past. So we heard very, very clearly the appetite of our shareholders for that part of our capital allocation.
Next question is from Emily Field from Barclays.
Emily Field from Barclays. I'll ask 2. First 1 on Dupixent. I was just wondering, I know early days for the launch in COPD. If you could give us any sort of early metrics about how you're seeing that launch in this new indication and just how you're thinking about the [ swiftness ] of the launch curve now that you're out there in the field.
And then that was a very helpful answer on use of proceeds from Opella, but I just wanted to see if I could get perhaps a little bit more color just because one of the questions that we've been getting frequently this week is with regards to just how much of the dilution from the sale of Opella could be offset with a share repurchase? So I was just wondering if perhaps you could provide any more specific comments on that point, that would be very helpful.
Thank you, Emily. Brian, Dupi, early thoughts on COPD launch?
Yes. Emily, thank you so much for the question. Obviously, we share your excitement for COPD, as has the marketplace as we've seen it. Now it's very early days, so we're just under a month of being out there in the United States. But as we had articulated before, this is a disease state, third-leading cause of death worldwide. No new meaningful innovation in the past 10 years. So you can imagine the marketplace is very excited.
It's too early to comment on trends. But what I can tell you is that the feedback has been extremely positive in the marketplace. And this really sets us up very nicely. I think as we talked about before, this is just the beginning of our COPD journey. So we've made another pipeline asset as well that's coming directly behind this. And I think the early feedback gives us even more confidence in that, in the guidance that we previously provided, that the 2 of those will likely be somewhere in the range of $5 billion at peak.
Emily, on the use of proceed on the dilution, let me clarify something first because I saw some analysis saying that the dilution linked to the separation of Opella was 11%, it is linked to the year 2023. Truly, for 2024, it will be closer to 9% given that our biopharma business has grown quite a lot in the meantime.
I'm not going to provide you more color on the antidilution activities that we could do, and especially share buyback and the portion of it that will mitigate the dilution. What I can tell you, though, is that don't be too worried about the dilution in 2024 because our business EPS in 2025 will increase over 2024 in absolute value regardless of -- I mean, even before any antidilution activities that we could go for.
So our business EPS will increase not just in -- at constant exchange, right, will increase in 2025 over 2024. And it will increase over '24 even with or without Opella. So the dilution will be anywhere even before anti-dilution activities will be absorbed.
Yes. Graham Parry from BofA.
Firstly on Beyfortus, just wondered, of the EUR 1.5 billion guidance that you're pointing to for the year now, just which countries are assumed in that? And roughly what sort of penetration do you target in key markets, such as U.S., France, Germany? And are there any more markets to come still that are not mentioned in the press release today?
And then secondly, on buybacks, just could you remind us of your current buyback authority that you have from the Board? And how much of that is left to execute independent of Opella or any cash receipts there? Is there anything that stops Sanofi from executing a buyback today or before Q2 next year, for example?
Okay. Thank you. I mean -- Graham, thank you. Yes, Beyfortus countries?
Graham. So as we indicated, we launched in 2024 in close to 20 countries, which includes, of course, North America. Western Europe, biggest market. Of course, last year, you know very well that we launched in Spain and in France. But we expanded to various markets, including, and we talked about it in the past before, [indiscernible]. I think it was Germany, Italy, Belgium and a few others. And we had a couple of South [ Emisa ] countries that we also have disclosed in previous earnings.
So most of the -- with the current launch has been done in those markets. So really focusing in North America and Western Europe. And there are more markets in which we'll launch next year.
Thank you, Thomas. And then the other part about the buyback. Just as you would imagine, particularly having entered into this period with Opella. We have an ongoing and active conversation with the Board on buybacks, as you would expect. And when we're ready to communicate our capital allocation decisions, we will of course share that with you immediately.
Next question from Seamus Fernandez from Guggenheim.
So just a couple. First on your strategy with amlitelimab. Just wanted to get a better sense of the importance of asthma in that data set.
And then also, how you're deciding to move forward with your OX40 TNF, given the data that are coming roughly around a similar time frame for that bispecific antibody?
And then incremental to some of the questions that have been asked. Just wanted to get a better sense of your commitment to the strong growth recovery that you've talked about in the past. I think now the consensus expectation is for anywhere from 15% to 18% growth year-over-year. And it seems like there's a potential acceleration in the overall biopharma business that could be coming with the removal of Opella from the base business. So just wanted to get a better sense of how we're thinking about the year-over-year growth expectation and opportunity there.
Okay, Seamus. Well, why don't we start with Houman on amlitelimab and asthma, and for the ligand TNF? And then François, could you comment on the strong recovery for next year, and the numbers which I'm unfamiliar, but that you mentioned.
Seamus, thank you for the question. We're more confident than ever about the importance of the OX40, OX40-Ligand pathway, in disease, as you've seen from our data in atopic dermatitis. We feel that we are best in class by virtue of targeting the ligand, which gives us biological distinction, both from a durability and efficacy perspective, but also from a safety perspective, to mitigate, for example, chills and other impacts.
Specifically with respect to asthma. OX40-Ligand is a apical node in many inflammatory processes. We have a great target credentialing across multiple indications. And we have been deeply committed to patients with asthma already with Dupixent and a number of other agents. We are committed to the asthma franchise, and we hope that amlitelimab will, in due course next year, provide the data for the forward motion in that position.
A short comment on your bispecifics. Thank you for bringing that into focus. Of course, they're internally developed molecules. We're confident now about our internal research and discovery activity. We're humble in the face of disease. We're not complacent. But we're excited to be generating a suite of internal molecules.
This one is, of course, the second one. You know about the first with lunsekimig, again, showing you -- with asthma. We look forward to the results of the double punch of blocking TNF and OX40 in a disease that we know is, from a credentialing perspective, influenced by TNF and OX40. Both of those results will come in the first half of next year, and we look forward to discussing them.
Thank you, Houman. Yes. I mean, AD is obviously a huge opportunity for amlitelimab. But asthma, based on the interval, if we can get there, would be a really great play. Okay, so François on...
Yes, Seamus. On the -- first and foremost, what is important to understand is exactly what you said, which is, with Sanofi as a pure biopharma company, we'll have a better growth profile and margin profile without Opella.
We confirm as well the fact that we expect a strong rebound in business EPS in 2025. The figure you mentioned is significantly above the consensus, which is around 12% to 13% for the time being.
Don't forget one thing, is that we have accelerated already in 2024, our business EPS. We revised our guidance upwards twice at the end of Q2 and just now at the end of Q3. So we are bringing forward to a certain extent the rebound. That being said, we do confirm still a strong rebound for 2025, but over a higher base in 2024, given that we have accelerated the rebound already starting in 2024.
Next question from Jo Walton from UBS.
Just to clarify, to confirm that when you present your full year '24 numbers, they will be on the new basis. So we won't be, at least on a headline basis, seeing the sales of Opella and all the earnings through. That will all be just a single discontinued line item that won't be in your business EPS...
Essentially correct, jo.
Excellent. And the other clarification, if you could give us any help on the tax rate that might be expected in FY '25, just given the comments about potential higher tax in France. If you could just give us a sense of what that might do.
But my main question is, please, any help you can give us on negotiations for IRA for next year in the U.S. Other companies have said that the loss of rebates, particularly in immunology because of the loss of the HUMIRA rebates, has made PBMs particularly hard in their negotiations for 2025 for rebates.
And of course, we note that Dupixent gets the first sort of proper competitor with Ebglyss from a major player that can also give heavy rebates for next year. So I wonder if you could talk a little bit about that, please.
So just to be clear, because we've sort of talked as well while you were talking. No Opella in the full year results. All right?
Yes.
Yes. So that, I confirmed already. And maybe also I can give you a little bit more color on the tax rate. As you probably saw, with the new scope without Opella, our underlying tax rate will go down from 21% with the former scope to about 20% with the new scope.
I want to mention as well that, with the new tax laws in France, we do expect an increase of our taxes in France. You may have seen that some of our peers in the CAC 40 have already disclosed significant amounts of tax increases. We will be probably at the lower end of some of the figures that have been mentioned by some of our peers in France.
And I want to reassure you as well that we do expect that probably in 2025, with what we know today, it's still early, that our underlying tax rate should remain relatively similar globally in spite of what's happening in France. Similar to what we expect in 2024, around 20%, given that we have ways to mitigate it outside of France. And we have some other countries that are reducing their tax rates and so forth. And with the mix of our geographies and activities, we should be able to maintain in 2025, with what we know today, the tax rate around 20% next year.
Thank you, François. Maybe, Brian, do you want to respond to the IRA question?
Yes, I'm happy to tackle it overall. So first and foremost, Jo, I think from an environment standpoint, the Inflation Reduction Act, there's a couple of things in there. And as we've said before, our position is it's not really good for innovation just in general, the Inflation Reduction Act.
That said, there are some pieces in there that we do agree with, which -- one of which is actually quite good for patients, is the no more than $2,000 out of pocket, and the ability to spread that across the months, could potentially allow these patients to have access to medicines that they haven't had before in the past. And we think that that's a good thing. So that's a positive side of things.
From an IRA standpoint, our portfolio actually lends us very well to this because we have an innovative portfolio, we have an innovative pipeline coming. And that's what we see, is the U.S. marketplace really values innovation. And so we don't really see any meaningful impact on our portfolio there for any reason for that matter, especially in relation to how -- the pricing provisions that are in place.
Now it relates to overall negotiation with payers. Again, I'll remind you specifically now on Dupixent because that was where the question was coming from, probably. We find ourselves in an excellent position. First and foremost, we have great underlying demand growth. That's where our growth is coming from. And we find ourselves in a good position because we've been executing a very clear strategy with the payers for quite some time to ensure, as we expand indications, that we are able to gain access, whether it's new channels.
And we find ourselves in a good position, and this is all taken into our guidance as we've provided to you for $13 billion this year as a target, or around $13 billion, and a double-digit CAGR growth from '23 through 2030.
Next question from Peter Welford from Jefferies.
I have two. One, first of all, coming back to the 2025. I wonder if you could provide perhaps a little bit more help for us on a few items that would help perhaps narrow the range a bit for consensus.
Firstly, is there any potential stranded costs that we should think about from the Opella in 2025 that will then become freed in -- perhaps in 2026?
And also, just you made the comment on the sales and marketing, that you've brought forward some of the investments to support the launches. How should we think about that, perhaps, going into 2025?
And then the second question is on Phase III trials for new vaccines. And I guess the question here is, first of all, with the Novavax and the deal you've done for the combination flu, would your intention be to run an efficacy study as you talked about for that?
And similarly, there's an FDA VRBPAC meeting, I think it's been callid on the 12th of December, to discuss pediatric RSV. Curious if you've been asked to participate in that. Because as far as I'm aware, you're the only Phase III pediatric RSV vaccine currently that is in the clinic.
Okay. Peter, thank you very much. So François, stranded cost, and anything they need to know about the Opella?
Yes, stranded cost. No, there will be some, but there is nothing material in any way stranded cost. By definition, we will have to limit them over time. So I would not be specifically worried about that. We can absorb them even including in 2025.
In sales and marketing, as you can see, we invest a little bit more than we originally planned, but given that we'll have a very strong momentum on the top line, I'm comfortable with it. I think it makes sense anyway. And we are -- so I think that there will be probably a bit of it in 2025 as well, but nothing major.
Thank you. Thomas, Novavax and ped RSV December meeting?
So thanks for the question. So the ped RSV meeting that was called for, you probably have seen the invitation. It's a very generic one, so we've not been particularly invited. But we will show up at the gate and we'll be there.
And as you mentioned, with our RSV toddler vaccines, which is currently in Phase III, going very strongly with the enrollment, I think we are very well positioned for that field, pending of course the Phase III outcome.
Second point you were mentioning. Novavax, our strategy is absolutely the same as the first day on. We are moving forward to start the Phase I/II this year, where we want to showcase that we can do our flu with Novavax COVID-19 together in a combination vaccine that does not compromise, neither on safety nor on efficacy. And our intention is, once we have results, if positive, we will immediately move next year towards Phase III, assuming Phase I/II positive data.
Next question from Luisa Hector from Berenberg.
The first one for Thomas, just to continue on the flu franchise. How soon do you expect a COVID-flu with an ACIP recommendation to be on the market?
And then second question is for Paul. 5 years, well done. So you've made enormous progress transforming the Sanofi business. But looking forward, R&D is the outstanding challenge. So what or when do you see as the most critical inflection points for determining progress in the R&D transformation? And how is the organization positioned to really maximize on pipeline successes, but as Houman mentioned, the inevitable failures that come with the territory? So essentially, is the pipeline big enough? And is the spend, both internal and external, sufficient?
Okay. My mid-year report, apparently. Okay. So flu, COVID, ACIP?
Yes. Thanks for the question, Luisa. A bit early to say. Again, what I think is very important to think is combination vaccines have a place moving forward, and we believe in it, provided and assuming that those combination vaccines do not have any compromise on safety or efficacy. I stand by that because, as you know very well, it's our intention, and has been for a while.
Now you also know that there are some competitors that are moving forward on this. Interestingly, Moderna, no name yet, has recognized that they need to provide efficacy data asked by the regulator on the flu component. You've seen that they are engaging on a very large Phase III scale to show if there is or not superiority, clinically demonstrated with clinical outcome, against standard of flu.
And I think it's going to be very important because you need to demonstrate clinical, statistically meaningful, superior efficacy versus standard flu to have a chance to be in the ACIP recommendation for 65 and above in the U.S.
So let's put things first in order. First, we need to see what is the efficacy bar they can pass with their product. Second, they will need to go indeed to registration and through ACIP recommendation. In any case, I don't see them as any competitor being there in 2025. We will be there, and our vaccines are leading in the marketplace and have shown a strong ability to have very good efficacy and very good tolerability. Will they be there in 2026 or later on? We still need to see the data which is still not coming.
Thank you, Thomas. For me, it's an interesting question. I mean, we studied a lot, particularly in the early part of the strategy of play to win, how long it takes to do an R&D turnaround. And it was sort of 5 to 7 years, was the average, if you look at some of the success stories. You know me a little bit now, and I'd like to have been faster. It wasn't to be.
And so we're literally -- we see ourselves at the beginning now of that journey. More proof points, more chances for success, rather than failure. But we -- and we built the pipeline that well, particularly in areas that we really know, like immunology and neurology vaccines, rare. And I think there's quite a bit to come.
I think the reason we changed the guidance last year is because we knew '24 and '25 were going to be important years for really seeing how far we have come.
Now of course, internally, we can be optimistic, but we're never far from people saying, "You're as good your success or failure." So we've got our heads down. We're doing hard work. I think our internal governances under Houman's leadership are much more demanding so that we try not to stub our toe on that journey, we've got more chance of really following the pathway and seeing if it gets done.
Of course, there's some really exciting assets in the pipeline, but they're still early. Some of the TNF, for example. So if we can get these things advanced, I think it really does change the nature of the company. And I've sort of learned over time in this job, that it's about getting more successes than failures. And it's such a balance. It's been a journey for me personally as a leader, but also I think for the organization as it's pivoted towards R&D.
So too early to say, I guess. Are we -- do we think we're there? I think we're not. But I do think we have more shots on goal that are better governed, that have better profiles, and that we've improved our POS. And if we can turn that into readouts, then I think we'll be extremely well positioned for the company and versus our peers.
Next question from Thibault Boutherin from Morgan Stanley.
Just a couple of questions on radioligands. You in-licensed projects for GEP-NETs. There is already a radioligand in this indication. So just wonder if you could comment on the positioning versus the standard of care and what you think you can achieve here.
And second question, still related to radioligand. If you could comment more broadly on your ambitions here. You also invested in a joint venture with Orano Med. So if you could comment on, is this kind of a one-off because you saw something specific here? Or is it a way for Sanofi to maybe be more present in the oncology space in a targeted way?
And also, if you could comment on anything regarding the supply chain for this, how it's handled between you and your partner? And your ambition on the space?
Okay. Thank you. Houman, radioligand, is it a one-off? What truth to it? And what about supply chain? And maybe Brendan has a view on that, I don't know.
Yes. Thanks, Paul. I'll start and hand over to my great colleague, Brendan. Here we go. So simple question, simple answer. The radioligand space has been validated by others with different modalities of treatment. We are extremely excited about developing innovative treatments for patients with large unmet medical needs.
Lead-212 is a particularly interesting modality within our perimeter that has both direct effects on tumors, but also in line with our adjacencies in immunoscience, is a way of activating immune response in tumors. So it has a double punch, again, a theme that is beginning to come through in our strategy in Sanofi.
So we're excited by the modality. We're excited by lead-212. Investing in promising innovative drugs is at the core of our strategy. And I have to say we are increasingly focused on under-delivering and overperforming. And in this case, the way this is manifest is in GEP-NET. The lead-212 molecule that we've started looking at has really very promising data in this rare form of cancer that, again, fits onto our rare disease franchise.
So the beauty of this opportunity is it knits together many of the areas in which we are -- we have the right to play and offer superior clinical benefits as well as limiting damage to adjacencies to these GEP-NETs and other tumors.
With respect to supply chain, Brendan, I wonder whether you can help.
Sure. So yes, getting treatment to patients in a timely and efficient manner obviously is paramount. And in that regard, we're working with Orano Med, who are true experts in this space. And we're quite confident in our ability to meet the supply requirements.
We have ample quantities of the base isotope, thorium-232, available, which will cover multiple, multiple years. And the process from which we then extract the isotope of interest, which is lead-212, does not -- it's a very robust chemical process. Does not rely on nuclear reactors or particle accelerators or any complex technology like that. So we're quite confident in their ability to secure a seamless supply chain.
We're building specialist alpha therapy labs close to the point of treatment, close to major distribution hubs, which will allow us to secure the availability of product within the time lines that are required for treatment. So in summary, we're very, very confident in Orano Med and the provisions they're putting in place.
Just one other comment, Brendan. One of the things we're incredibly proud of is the ability to leverage talent and technology in France, which is a unique differentiator we have. And the ability to work with a French leader in nuclear technology is something that is uniquely available to us as Sanofi. We're very proud to be working with this partner.
Yes, I think the last one because it was asked, but Thibault, about supply, I think it's sort of noticed, isn't it, that it's one of the more difficult things to do. Because they're all advances, frankly. So hopefully, we can take advantage of that with that technical capability, too.
Next question is from Simon Baker from Redburn.
Two if I may, please. Firstly, on Beyfortus. Could you just remind us where we currently are, where you currently are, with capacity. And how that will evolve in '25 and '26.
And then the second question, going back to Opella. I wanted to ask about the influence that Bpifrance will have. Specifically, any influence they have beyond their one board seat.
Okay. Thank you, Simon. Beyfortus capacity?
Great. Has been a lot of work that has been done by our manufacturing partners and all stakeholders involved. As you know very well, we've added 2 filling lines up and running, and we're going full speed. So with the 20 markets we just launched in 2024, we don't see any capacity limitation. And we'll grow that supply for next year and the year after to make sure that there will be, again, no supply constraints anticipated at all in '25, '26.
Okay. Thank you. François to comment on Bpi?
On the Bpi. So the fact that Bpi is joining us show the attractiveness of the business case as far as Opella is concerned. Typically, I mean, when you have 1% to 2% shareholding in the company, I mean, the governance attached to it is relatively limited. So this is a classical -- this is what happens in that case. It's in line with market practice for a stake of around 1% to 2%.
Next question is from Steve Scala from TD Cowen.
Can you hear me?
Yes.
Does Sanofi have any efficacy data for Beyfortus which supports protection through 6 months? And what percent of RSV cases fall between 5 and 6 months? This would appear to be 1 advantage that Merck may indeed have.
And then second, is Sanofi on track to initiate Phase III trials for its 21-valent pneumococcal vaccine this year? And is it still commercially viable given the competitor's 31-valent data?
Thank you, Steve. Excellent questions. Thomas on durability.
It's a great question. First of all, do we have data over 6 months? Absolutely. And we made the reference in a slide that is today into this presentation. We've just made this data published and they are available.
And as you will see, what's very nice with this data is that there is no waning efficacy after 6 months. We still see 83% efficacy against hospitalization after 6 full months. And we are very confident that we have kept running for another data point after that, the efficacy will still go very well.
So I actually believe that duration of protection is significantly in favor of Beyfortus compared to clesvorimab, which I would recommend to look at a couple of points. I would suggest that people look at the available data regarding to the half-life of both products where you see a significant difference. One is above 40 days, the other one is about 70 days half life. So a significant difference between both products.
And I also remind everyone that for the coming ACIP discussions, our competitor will need to show the Kaplan-Meier curves of their Phase III efficacy data that we show what is the number of new cases and the associated protections in the month of fourth month, fifth month and sixth months, which will be very different, we believe, than what we have observed with Beyfortus because we believe that most of the cases in our competitors' Phase III were in the very early phases. So I do believe that duration is going to be a very important point to look at in the coming period.
Thank you. And pneumococcal?
And on PCV21, thank you very much because it's a very important product for our pediatric portfolio. We are fully on track to start Phase III in 2024. I confirm that.
And the next part of your question was, is it a viable product? Absolutely. And you fully understand that our goal is not just to do the PCV21, stop, and that's it. Our goal is to have the first-ever pediatric pneumo-conjugate vaccine product with more than 20 valence available on the marketplace. And from that first base, that would already be the first milestone, then we will be further with additional serotypes. So we will -- once you're in that race, you always want to remain competitive.
Next question from is from David Risinger, Leerink.
Yes. Can you hear me okay?
Yes.
Great. So congrats on the financial results. I have 2 questions. First, regarding Amgen's OX40 Phase III efficacy. Since it was lower than expected, did the weak efficacy results impact your expectations for forthcoming amlitelimab efficacy?
And then -- sorry about the noise. Second, Sanofi has several I&I pipeline readouts over the next year. Could you please provide a framework on how the company plans to disclose the slew of results that are coming, including 4 Phase II data readouts which will be important proof of concepts?
Okay. Thank you, David. So comments, Houman, on OX40-Ligand and the sort of the results from Amgen?
Yes. So thanks much for the question. We remain very excited about the OX40 pathway in general. We were very detailed in our credentialing this target before we went into the space. And all the publicly available data to support an even stronger perspective on the importance of the OX40 pathway.
However, the differentiation of the OX40 receptor versus the ligand may be manifest in the data that's come from Amgen. What I'm confident in being able to say is that targeting the ligand with its impact on not diluting T cells, but retaining them, may well, and is likely to, translate in greater durability and higher efficacy. But also, it's now very clear that the side effect profile of the ligand is much better than the receptor.
But to give you a very simple and clear summary. We think the presence of another molecule, the tide raises all boats. It's great to have other players in atopic dermatitis space because it allows a much greater education of the population and a greater bio penetration. However, I think targeting the ligand has now been shown to be a better, more effective intervention.
And extremely quickly to your second question. You are right. We are blessed to have a number of very significant readouts coming out in the next year. We will focus on presenting and disclosing our results in the appropriate form, most of which will be in scientific congresses. We are, however, deeply conscious of our compliance responsibilities and our responsibilities to The Street. And if they are material, of course, we will hasten to convey them to the street as quickly as possible.
Next question is from Richard Parkes from BNP Exane.
Just coming back to Beyfortus and expectations into 2025, I wondered if we could just push you a little bit more on that. If, in the worst case, competition does materialize, just wondering whether you would be willing to commit to still being able to grow the franchise even with or without competition, maybe through international launches?
And then related to that, I think of the Vaccines Day a couple of years ago, you put up a slide implying RSV infant market forecast of EUR 2.4 billion by 2030. I'm sure your thinking has evolved since then. So could you just update us on your current thinking over the total commercial potential?
Okay. Thank you for that, Richard. So Beyfortus market, how's it going to develop?
No significant change on our RSV overall market anticipation for 2030. You also noticed, though, that on top of the RSV in newborn, there will be the RSV infant and the so-called RSV toddler vaccines coming down the road for kids to be protected at age 1 and above. So that will, of course, be a very interesting path for us.
But back to the initial part of your question. On the 2025 outlook and what's the outlook with or without competitor? Let me be very clear because I might have missed it in the first time. But with or without competitors, 2025 will be a year of growth for Beyfortus.
Again, there is a significant number of newborns that do require RSV protections. We believe that it's not reasonable, and it's totally unfair from an ethical perspective to make sure that there is RSV protection for some baby and not for some others. That's why we're 100% on All Infant Protection.
All Infant Protection can only be provided by monoclonal antibodies and not maternal immunization. That's why it's very good to have further voices pushing on All Infant Protection. The playing field will increase with or without the competitor. And therefore, with or without the competitor, Beyfortus will grow in 2025.
Thank you. And thanks, Richard, for going back and looking at that deck. It was a good deck with a lot of nuggets in there about how things would develop. We should probably take another look at that, too.
Next question is from Rajesh Kumar from HSBC.
Another one on Beyfortus versus clesvorimab. One of the points which Merck are making is the stocking up is much easier if the dose is body weight -- not dependent on the body weight. So how do you help the providers with stocking of inventory for different body weight infants? And how can you ensure that doesn't become a significant disadvantage for you? Obviously, efficacy and all the data points you've made are well noted. So -- but this aspect of practical ordering might be helpful to understand.
And just a clarification on Opella. Can you just run through in terms of the cash proceeds you've guided to? That's after tax or before tax?
Okay. Thanks, Raj. Beyfortus stocking?
Yes. So the matter on those, and I'm coming back to that in a second, Rajesh. But as you started to add in your question, indeed, it's 2 monoclonal antibodies now both targeting RSV, but there are significant differences. I think in the coming years, I believe it can be very interesting to highlight hose.
First and foremost, Beyfortus has demonstrated RSV protection in the real world and has been studied in more than 75,000 infants. That's a very significant number of kids. Showing a very high bar.
Second of all, when you look specifically at the efficacy for the primary endpoint against RSV, medically attended RSV disease, with the usual caveat, of course, that when you have -- when you're comparing across trials, you've seen that Beyfortus has shown a higher efficacy of the said endpoint at around 75% versus clesvorimab at 60%.
I do believe it's important because while we absolutely want to make sure that we present hospitalization, one of the most severe outcomes, we also want to make sure, and I'm sure parents want to make sure, that they can increase their chance of not missing 1, 2 or 3 days of work in order to have to bring their newborn at multiple doctor visits. So I think that we have with Beyfortus the product that has shown high efficacy against both severe and less severe outcomes.
And finally, the safety profile is a very important point. This is the newborn population. That's the most fragile part of the population. And we've shown a pristine safety profile year-on-year and a very high duration with 180 days.
Now back to your question, does that mean that the dosage on clesvorimab is a significant differentiator? Actually, we don't think this is an issue at all.
First of all, because we've talked a lot about this. Adding 2 doses -- or 2 dosages, should I say, is important because the right dose is fitting the right channel. The smallest babies typically at newborn time are weighing less than 5 kilograms. They should receive a 50-milligram dose. These babies usually do get those doses in the hospital channel or within a maternity setting.
On the other hand, babies that are weighing more than 5 kilograms should receive a 100-milligram dose, which are normally older babies that get it within the pediatrician clinic setups. So each channel has a very well corresponding specific dosage that goes very well.
And finally on the dosage point. I think it's going to be very interesting for doctors to see that our findings in clinical studies is that 50-milligram doses for our product for newborns is exactly the right choice as it delivers the best efficacy with the smallest possible dose for newborn babies. And we have good arguments on those points, too.
Thank you very much. François?
Yes. On the tax -- on the amount of cash that we will receive at the earliest in Q2 2025 for Opella. It's a high single-digit number in billions of euros net of tax, net of any other cost, the transaction costs as well. This is really a net kind of deposit, at the earliest in Q2.
Thank you. I think we have 2 questions left. I think Eric and Florent. So over to the next question.
Yes. Next question is from Eric Berrigaud from Stifel.
Yes. Two questions. First, in recent interactions with investors, it looks like there's a topic that comes through more often around Dupixent LoE extension. I'm unclear whether it comes from you, from your partner or from any other source. But maybe you can update us on where you stand about extending LoE of Dupixent.
And the second question. Maybe I missed it, but I don't see any updates into your pipeline agenda about the anti-TL1A. Do you expect this to come from Teva? Or what can you -- what -- when can we expect some Phase II update on that specific asset?
Okay, thank you. Roy, over to you on Dupi loss of exclusivity.
Sure. The Dupixent compound product expires in the U.S. in March 2031. This is the patent term extended expiration date. In Europe, it's March 2033, which is the SPC extended expiration date with pediatric facility, which is in the process of being granted across EU member states. We are referring to these compound patent expiration dates as the LOE dates.
On top of that, in both the U.S. and Europe, there's further patent applications covering inventions related to Dupixent which have expiration dates ranging from '32 to '44. It is too early to speculate on later LOE dates for Dupixent at this stage.
Okay. Thank you, Roy. And our strategies are internal because, of course, lots of people are interested in which way we decide to go. Okay. And then Houman, anti-TL1A?
Briefly. Thanks for the question. As you've seen in the deck, you back it to -- as it's well known, that our anti-TL1A reads out in H2 2024. You should expect a comment from our partner, Teva, and ourselves later this year or early next year. And we'll be very excited to share that with you when we see the data.
Okay, thank you. And I think it may be the last question for Florent.
Yes. Last question from Florent Cespedes from Bernstein.
Florent Cespedes from Bernstein. Two quick questions, please. First, for Houman on hidradenitis suppurativa. In fact, next year, first half, you will have 3 Phase II trials that will read out on this -- for this indication with 3 different mechanism of action. I was just wondering if you could give us a little bit more color on your strategy on this population as you have already your products in the market. They are quite successful. So some thoughts on this would be great, and notably also in terms of potential of this market.
And my second question is for Thomas. It's a follow-up on Beyfortus. I was just wondering if we could have a little bit more color about manufacturing capacities for 2025. Is there a third manufacturing line that will be ready next year? And when you mentioned, Thomas, that there will be growth in 2025, I was just wondering if you could give us a little bit more color on this. Can you quantify this?
Thank you, Florent. HS, Houman and Brian, if you have a comment. But certainly, Houman to start with.
Yes. Florent, thanks for the question. Thank you for focusing the lens on HS, which is a highly unmet medical need, highly heterogeneous condition with multiple stages of that. The early stage being inflammatory, and later on having multiple fistulas disease with -- requiring surgical debridement. It's a complicated disorder with substantial stratification. And as you know, I was involved with the first-generation molecules in HS.
HS really does exemplify our strategy very clearly. Firstly, we are committed to franchises rather than individual molecules. We want to serve our patients and the physicians in all stages and grades of disease.
In this case, we used the well credentialed target of OX40-Ligand in this situation as part of our signal-seeking life cycle management strategy with amlitelimab. We have always said that we want to go bio and better bio, understanding the targets more clearly and leveraging our internal technologies here, combining TNF, highly validated, and OX40-Ligand, which is preclinically credentialed. Putting those together using our own Ablynx technology. The nanobody technology gives us an opportunity to serve patients with a bio better, as well as the anti-TNF, which is already on the market, and amlitelimab.
And then moving one step forward, we've always expressed a view that, as well as antibody, we go out to provide optionality for patients with a small molecule. That's why our IRAK4 degrader, which we work very closely with our partner, gives us further optionality in the space. And we look forward to seeing what the data in the space shows.
So when we think about HS, we think about franchises, we think about stratification, and we think about optionality to ensure that we serve the whole strata of every patient.
Okay. Great. Thank you very much. I think on Beyfortus.
On Beyfortus capacity, Florent. As you know very well, we are shooting and we've communicated this to triple capacity in 2024, and we've done that. So you were talking about a third line. Let me be very clear. We have already started to release and distribute Beyfortus already from the third line as we speak already. So this is already installed, and that's why I'm very confident that there is no supply challenges that I can talk in terms of constraints for '25 and beyond.
In addition, I think you were going back to the growth in 2025. A bit too early to give you some further color on this. As you know very well, when it comes to immunization schedule, first, there needs to be recommendation set up by the new countries in which we're going to launch. And then we'll be able to see more clearly the overall landscape we have for '25.
Where I do see growth coming down the road is a North America increase, I would say, penetration of monoclonal antibodies, but also an increase of Beyfortus in Europe and in the international zones with more countries we're going to launch into.
Brilliant, Thomas. Well, thanks for that, the last question.
Our strong business momentum continued in the third quarter with an estimated underlying 11% growth at CER. We continued to execute on our launches. We kept advancing our pipeline of new medicines. And we recently upgraded our 2024 EPS guidance. I'm pleased with our progress in becoming a pure play and science-focused biopharma company committed to serving patients and accelerating growth.
And thanks to all of you for your interest in Sanofi.