Sanofi (SNY) Q3 2024 Earnings Call Transcript

Sanofi (SNY 3.94%)
Q3 2024 Earnings Call
Oct 25, 2024, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Thomas Kudsk Larsen — Head of Investor Relations

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 number 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 is 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 on d’Enregistrement 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 in million euros and for Q3 2024 unless stated otherwise. Please turn to Slide number 4. [Operator instructions] For Q&A, we have Brian, Olivier, Thomas, and Julie to cover the global business and Roy, our general counsel.

[Operator instructions] And with this I’ll now hand you over to Paul.

Paul Hudson — Chief Executive Officer

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 13.4 billion euro, a 16% increase in CER and 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 EUR3.5 billion in the quarter. Our Vaccine business grew 26%.

This increase benefited from an element of phasing in the 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 eight medicines that we have recently launched and a clear illustration of the value those medicines bring to healthcare 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 healthcare 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 the 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 No. 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 13 billion euro 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 four months ago, speaks volumes of our ability to move decisively, execute, and meet the need for more treatment options. The expansion of Dupixent and 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 3 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 three 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 3 billion euro in the first nine months, our launches have become significant contributors to Sanofi’s accelerated top line growth profile. Beyfortus leads the way with sales of 645 million euro in Q3 showing an exceptional market uptake in its second season and underscoring the critical role it plays in all infant protection.

With sales of a 172 million euros ALTUVIIIO further established its position as the new high efficacy standard of care in hemophilia A demonstrated by patient switches from other factor and non-factor medicines. Other innovative medicines like Nexviazyme, Rezurock, and Sarclisa continue to perform well and are contributing to a total of 1.4 billion euros 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 market leader in all infant protection. A recent study demonstrates that Beyfortus continues to protect infants against RSV hospitalization over a full six 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 shown 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’re on our 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’ve 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 Fairwage 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 Francois, our CFO.

Francois Roger — Chief Financial Officer

Thank you, Paul. Good morning and good afternoon to all. Before I start, let me clarify that financials for this quarter include 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 EUR13.4 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 a positive mix effects partly offset by currency impacts on the Aubagio loss of exclusivity. Higher R&D expenses are aligned 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. Free viewing 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 one less invoicing 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 1.5 billion euros in 2024, a remarkable performance in its first full year of marketing.

For Q4, please remember that we had around 400 million euros of one-off COVID revenues in Q4 2023 as well as the associated margin. We confirm our full-year guidance to increase R&D cost by around 700 million euros 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 300 million euros in 2024 and we anticipate capital gains from divestments to be around 400 million euros 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 two quarters, and this reflects our confidence in our view. 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 negotiation 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 16 billion euros EV is very attractive. The 14 times 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 or 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.

Houman Ashrafian — Global Head of Research and Development

Thanks, Francois. We’ve achieved several milestones this quarter showing our continuous 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 with 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 3 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 in autoimmune and inflammatory disorders with an NLRP3 inhibitor in phase 2. Another biotech company that piqued our interest focused on immunology was AnaptysBio with its potential best-in-class phase 2b PD1 agonist tested in RA and UC and in Vicore with our potential best-in-class phase 2b angiotensin 2 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 external optionality for our pipeline and complement the work we’re doing internally in research. On the next slide, last month at the ECTRIMS conference, we presented tolebrutinib’s phase 3 data in RMS and nrSPMS. We didn’t meet the primary endpoint in the relapsing multiple sclerosis study.

However, pooled analysis of six months 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 time to onset of SIX month CDP by 31% with further analysis of secondary endpoints showing the number of participants who experienced confirmed disability improvement increased by nearly two-fold. So 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 resolved without sequelae they all occurred in the first 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 2b atopic dermatitis data from the 68-week STREAM-AD study at the EADV conference.

The study had three parts. The first one, the primary endpoint percentage change in EASI was made at 16 weeks, followed by a second path for 28 weeks where most patients saw a durability of clinical response after withdrawal at 24 weeks. And the safety follow-up is 16 weeks. Throughout the 68 weeks, amlitelimab demonstrated a pleasing safety profile with most patient reporting TEAEs which were very mild or moderate in severity and none led to discontinuation of the treatment, emphasizing a differentiated safety profile complementing its confirmed efficacy.

Durability was demonstrated with a sustained percentage of AESI 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 envisioned. All phase 3 studies in the OCEANA program are ongoing. Readouts plan 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 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 six phase 3 readouts, 11 submissions, and 10 regulatory decisions 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 in our core focused therapeutic areas 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.

Paul Hudson — Chief Executive Officer

Well, thank you, Houman. We’ll now have the call to questions. As a reminder, we would like you to limit your questions to one or two each. We say that every time.

I’m not sure anybody hears it, but say it anyway. You’ll be notified when your line is open to ask your question. At that time, please make sure you unmute your microphone or option two, submit your question by clicking the Q&A icon at the bottom of the screen. Your question will be read by our panelists.

Now we take the first question, please. Go ahead.

Questions & Answers:

Operator

Yes. First question from Richard Vosser from J.P. Morgan. Richard?

Richard Vosser — Analyst

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 Clesrovimab. 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 Opella — pass down to Opella? Thanks.

Paul Hudson — Chief Executive Officer

Thank you, Richard. Beyfortus is very easy to say. Thomas?

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

No, I can’t say the other one. Thanks for the question, Richard. Very good point indeed. A few first points to start with.

First of all, there’s still a lot to go in terms of monoclonal antibody penetration. So we really welcome, but 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 to, we’ll be more than one to actually sing that song and make sure that more and more babies get productive moving forward.

Now in terms of the ACIP presentation, as you were pointing out too, they were showing still some important differences between the two products. It’s still early data for our competitors. We’ve seen just some data, not all of it. We are very confident in the data that we have demonstrated in both our phase 3 and our reward evidence data, be it in actual efficacy, not 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 two products.

Paul Hudson — Chief Executive Officer

Francois, Opella deal and proceeds.

Francois Roger — Chief Financial Officer

Yes. So on the Opella deal, indeed I confirm that we expect to receive at the earliest in Q4 2025, a high-single-digit number in billions of euros, once again not earlier than Q2. Just one small comment on the amounts. 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 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 double rate. We will maintain our dividend policy to increase our dividend in absolute value in euro as we have always — already done over the last 30 years and we will obviously look at anti-dilutive share buybacks.

We heard loud and clear the shareholder — 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.

Paul Hudson — Chief Executive Officer

Thank you. Next question, please.

Operator

Yes. Next question is from Emily Field from Barclays.

Emily Field — Barclays — Analyst

Hi. Emily Field from Barclays. Thanks for taking my question. I’ll ask two.

First one on Dupixent. I was just wondering, I know it’s very 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 for 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 the 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.

Paul Hudson — Chief Executive Officer

Thank you, Emily. Brian, Dupi, early thoughts on COPD launch?

Brian Foard — Global Business Unit Head, Specialty Care

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 be 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 two of those will likely be somewhere in the range of $5 billion at peak.

Paul Hudson — Chief Executive Officer

OK. Yes, Francois.

Francois Roger — Chief Financial Officer

Emily, on the use of proceeds 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. 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 dilution and the anti-dilution activity 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 anti-dilution activities that we could go for. So our business EPS will increase I must just say in at constant exchange rate will increase in 2025 over 2024. And it will increase over 2024 even with or without Opella. So the dilution will be anywhere even before anti-dilution activities will be absorbed.

Paul Hudson — Chief Executive Officer

Thank you. Next question, please.

Operator

Yes. Graham Parry from BofA. Graham?

Graham Parry — Analyst

Great. Thanks for taking my question. So firstly, on Beyfortus just wondered of the 1.5 billion euro 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 an independence 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? Thank you.

Paul Hudson — Chief Executive Officer

OK. Thank you. I mean, Graham, thank you. Yes, Beyfortus, countries?

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

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 where we launched in Spain, in France, but we expanded to various markets, including and we talked about it in the past before, that includes Portugal, that includes Germany, that includes Italy, that includes Belgium and a few others. And we had a couple of South America countries that was disclosed in previous earnings.

So most of the current launch have been done in those markets, so refocusing in North America and Western Europe. And there are more markets in which we’ll launch next year.

Paul Hudson — Chief Executive Officer

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.

OK. Next question.

Operator

Yes. Next question from Seamus Fernandez from Guggenheim. Seamus?

Seamus Fernandez — Analyst

Thanks for the question. 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. Thanks so much.

Paul Hudson — Chief Executive Officer

OK, Seamus. Well, why don’t we start with Houman on amlitelimab and asthma and for the ligand TNF and then Francois to comment on the strong recovery for next year and the numbers which are unfamiliar that you mentioned.

Houman Ashrafian — Global Head of Research and Development

Seamus, thanks 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 and 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 an 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, provided the data to support 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 lunsekimig again showing you coming with asthma. We look forward to the results of the double punch of blocking TNF and OX40. And the 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.

Paul Hudson — Chief Executive Officer

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. OK.

So Francois?

Francois Roger — Chief Financial Officer

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.

Paul Hudson — Chief Executive Officer

OK. Thank you. Next question?

Operator

Yes. Next question from Jo Walton from UBS. Jo?

Jo Walton — UBS — Analyst

Thank you. 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.

Paul Hudson — Chief Executive Officer

Correct.

Jo Walton — UBS — Analyst

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 rebate 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.

Francois Roger — Chief Financial Officer

Hi, Jo. So just to be clear because we’ve sort of talked as well while you were talking no Opella in the full year results, right. Yes, that I confirmed already. And maybe, Francois, 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 strong 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.

Paul Hudson — Chief Executive Officer

Thank you, Francois. Maybe, Brian, do you want to respond to the RA question?

Brian Foard — Global Business Unit Head, Specialty Care

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 as 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 of around $13 billion and a double-digit CAGR growth from ’23 through 2030.

Paul Hudson — Chief Executive Officer

Thank you, Brian. Next question, please.

Operator

Yes. Next question from Peter Welford from Jefferies. Peter?

Peter Welford — Jefferies — Analyst

Hi. Thanks so much for taking my questions. 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 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 3 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, been calls 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 3 pediatric RSV vaccine currently that is in the clinic. Thank you.

Paul Hudson — Chief Executive Officer

OK. Peter, thank you very much. So, Francois, stranded costs, anything they need to know about the development?

Francois Roger — Chief Financial Officer

Yes, stranded costs, no, there will be some, but there is nothing material on U.S. stranded costs 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 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.

Paul Hudson — Chief Executive Officer

Thank you. Thomas, Novavax and PED RSV December billing.

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

Yeah. 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 polio vaccines, which is currently in phase 3, going very strongly with the environment. I think we are very well-positioned for that field pending, of course, the phase 3 outcome.

Second point you were mentioning Novavax. Our strategy is absolutely the same as the first day one. We are moving forward to start the phase 1/2 this year where we want to showcase that we can do outflow with Novavax COVID-19 together in a combination vaccine that does not compromise neither on safety no on efficacy. And our intention is once we have results, if positive, we will immediately move next year toward phase 3, assuming phase 1/2 positive data.

Paul Hudson — Chief Executive Officer

Thank you. Next question, please.

Operator

Next question from Luisa Hector from Berenberg. Luisa?

Luisa Hector — Berenberg Capital Markets — Analyst

Hi, there. Thank you for taking my question. 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.

Five 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? Thanks.

Paul Hudson — Chief Executive Officer

OK. I made your report apparently. OK. So flu COVD, ACIP?

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

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 commission vaccines do not have any compromise on safety or efficacy.

I start by that because as you know very well, it’s our intention to move vaccine forward. Now you also know that there are some competitors that are moving forward on this. Interestingly, Moderna not to name it, has recognize 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 3 scale to show if there is or not superiority, clinically demonstrated with clinical outcome against standard dose flu.

And I think it’s going to be very important because you need to demonstrate clinical statistically meaningful superior efficacy versus standard dose to have a chance to be in the ACIP recommendation for 65 and 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 SAP 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 be there in 2026 or later on. We still need to see the data, which is still not coming.

Paul Hudson — Chief Executive Officer

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 five to seven 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’ve built the pipeline that well, particularly in areas that we really know like immunology, 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 as you next 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 and 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 toward 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. OK.

Next question.

Operator

Next question from Thibault Boutherin from Morgan Stanley. Thibault?

Thibault Boutherin — Morgan Stanley — Analyst

Yes. Thank you. Just a couple of questions on radioligand. You in-licensed a project for GEP-NET.

There is already a radioligand 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 presence 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? Thank you.

Paul Hudson — Chief Executive Officer

OK. Thank you. Houman, radioligand, is it a one-off? What drew us to it? And what about supply chain? And maybe Brendan has a view on that, I don’t know.

Houman Ashrafian — Global Head of Research and Development

Yes. Thanks, Paul. I’ll start and hand over to my great colleague, Brendan as 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 as an alpha emitter 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 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-NET and other tumors. With respect to supply chain, Brendan, I wonder whether you can help.

Brendan O’Callaghan — Head of Industrial Affairs

Sure. So yes, getting treatment to patients in a timely, 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 you’ve covered multiple, multiple years and the process from which we then extract the isotope interest, which is Lead-212 does not — it’s a very robust chemical process does not rely on nuclear reactors or practical accelerators or any complex technology like that.

So we’re quite confident in their ability to secure seemless supply chain. We’re building specialist alpha therapy labs close to the points of treatment, close to major distribution hubs, which you 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.

Houman Ashrafian — Global Head of Research and Development

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 in Sanofi. We’re very proud to be working with this partner.

Paul Hudson — Chief Executive Officer

Yes, I think, on the last point because it was asked, 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. OK.

Next question.

Operator

Yes. Next question is from Simon Baker from Redburn. Simon?

Simon Baker — Analyst

Thank you very much for taking my questions. Two if I may please. Firstly, on Beyfortus. Could you just remind us where we currently or 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 BPI France will have. Specifically, any influence they have beyond the one board seat. Thanks very much.

Paul Hudson — Chief Executive Officer

OK. Thank you, Simon. Beyfortus capacity.

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

Great. There 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 two filling lines up and running, and we’re doing 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.

Paul Hudson — Chief Executive Officer

OK. Thank you. Francois, any comment on the BPI?

Francois Roger — Chief Financial Officer

On the BPI, so the fact that BPI is joining us for 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 prices for a stake of around 1% to 2%.

Paul Hudson — Chief Executive Officer

OK. Next question.

Operator

Yes. Next question is from Steve Scala from TD Cowen. Steve?

Steve Scala — Analyst

Can you hear me?

Paul Hudson — Chief Executive Officer

Yeah.

Steve Scala — Analyst

Thank you. Does Sanofi have any efficacy data for Beyfortus, which supports protection through six months and what percent of RSV cases fall between five and six months. This would appear to be one advantage that Merck may indeed have. And then second is Sanofi on track to initiate phase 3 trials for its 21-valent pneumococcal vaccine this year? And is it still commercially viable given the competitor’s 31-valent data?

Paul Hudson — Chief Executive Officer

Thank you, Steve. Excellent questions. Thomas, on durability.

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

It’s a great question. First of all, do we have data over six 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 winning efficacy after six months. We still see 83% efficacy against hospitalization after six 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 Iscalimab, which I would recommend to look at a couple of points. I would suggest that people look at the available data returning to the half-life of both products where you see a significant difference.

One is above 40 days. The other one is above 70 days half-life. So a significant difference between both products. And I remind also everyone that for the coming ACIP discussions, our competitor will need to show the Kaplan-Meier curves of their phase 3 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 3 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 periods.

Paul Hudson — Chief Executive Officer

Thank you and pneumococcal.

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

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 3 in 2024. I confirm that and the next part of your question was, is it a variable product? Absolutely. And you fully understand that our goal is not just to do a PCV21 stuff and that’s it.

Our goal is to have the first and the first ever pediatric pneumo conjugate vaccines product with more than 20-valent available on the marketplace. And from that first base, that will 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 competitively.

Paul Hudson — Chief Executive Officer

Thank you. Very clear. Next question, please

Operator

Yes. Next question is from David Risinger, Leerink. David?

David Risinger — Analyst

Yes. Can you hear me OK?

Paul Hudson — Chief Executive Officer

Yes.

David Risinger — Analyst

Great. So congrats on the financial results. I have two questions. First, regarding Amgen’s OX40 phase 3 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 for phase 2 data readouts, which will be important proof-of-concepts. Thank you.

Paul Hudson — Chief Executive Officer

OK. Thank you, David. So, Thomas on OX40 ligand and the sort of the results from Amgen.

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

Yes. So thanks much for the question. We remain very excited about the OX40 pathway in general. We were very detailed in our credential in 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 deleting 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 your boat. It’s great to have other players in atopic dermatitis space because it allows a much greater education of the population and a greater biopeneration. 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 the 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.

Paul Hudson — Chief Executive Officer

OK. Thank you. Next question.

Operator

Yes. Next question is from Richard Parkes from BNP Exane. Richard?

Richard Parkes — Analyst

Hi. Thanks very much for taking my questions. 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, at the Vaccine Day a couple of years ago, you put a slide implying RSV infant market forecast of 2.4 billion euro 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? Thank you.

Paul Hudson — Chief Executive Officer

OK. Thank you for that, Richard. So Beyfortus market, how’s it going to develop?

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

No significant change on our RSV overall market antipation for 2030. You also noticed though that on top of the RSV newborn, there will be the RSV infant RF. The so-called RSV total vaccines coming down the road for kids to be protected at age one and above. So that will, of course, be a very interesting part 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 a IV 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 move in 2025.

Paul Hudson — Chief Executive Officer

Thank you, and thanks, Richard for going back and looking at that deck. It was a good deck with other nuggets in there about how things would develop. We should probably take another look at that too. OK.

Next question, please.

Operator

Next question is from Rajesh Kumar from HSBC.

Rajesh Kumar — HSBC — Analyst

Hi. Thanks for taking my question. Another one on Beyfortus versus Clesrovimab. When 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 up 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? Thank you.

Paul Hudson — Chief Executive Officer

OK. Thanks, Rajesh. They offered us a stocking.

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

Yeah. So the matter on those, I’m coming back to that in a second, Rajesh. But as you started to add in your question, indeed, it’s two monoclonal antibodies, both targeting RSV, but there are significant differences. I think in the coming ACIP meeting will be very interesting to highlight those.

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 of efficacy. Second of all, when you look specifically at the efficacy for the primary endpoint against RSV, medically attended LRT 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 estimated point around 75% versus Clesrovimab 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 one, two or three days of work in order to have to bring their newborn at multiple doctor visits. So I think that we had with Beyfortus a 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, but the most fragile part of the population, and we’ve shown a pristine safety profile year on year and very high duration with 180 days.

Now back to your question, does that mean that the dosage on Clesrovimab is a significant differentiator. Actually, we don’t think this is an issue at all. First of all, because we’ve thought a lot about this. Adding two doses or two 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 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 but getting within the efficient 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 new born is exactly the right choice as it delivers the best efficacy with the smallest possible dose for newborn babies. I think we have good arguments on those point too.

Paul Hudson — Chief Executive Officer

Thank you very much, Francois.

Francois Roger — Chief Financial Officer

Yeah. On the tax — on the amount of cash that we will receive at the earliest in Q2 2025 for Opella, we confirm it’s a high-single-digit number in billions of euros net of tax, net of any other cost such as transaction costs as well. So this is really a net tax possibly that we will get at the earliest in Q2.

Paul Hudson — Chief Executive Officer

Thank you. I think we have two questions left. I think Eric from Florent. So over to the next question.

Operator

Yes. Next question is from Eric Le Berrigaud from Stifel. Eric?

Eric Le Berrigaud — Stifel Financial Corp. — Analyst

Yes. Thank you. Good afternoon. 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 update 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 2 update on that specific assets? Thank you.

Paul Hudson — Chief Executive Officer

OK. Thank you. Roy, over to you on Dupi loss of exclusivity.

Roy Papatheodoru — Executive Vice President, General Counsel

Sure. The Dupixent compound partner 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 exclusivity, 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 and patent applications covering inventions related to Dupixent which have expiration dates ranging from 33% to 44%.

It is too early to speculate on later LOE dates for Dupixent at this stage.

Paul Hudson — Chief Executive Officer

OK. Thank you, Roy. And our strategies are internal because, of course, lots of people are interested in which way we decide to go. OK.

And then Houman on anti-TL1A.

Houman Ashrafian — Global Head of Research and Development

Briefly, thanks for the question. As you’ve seen in the deck [Inaudible] as it’s now known and 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.

Paul Hudson — Chief Executive Officer

OK. Thank you. And I think it may be the last question for Florent.

Operator

Yes. Last question from Florent Cespedes from Bernstein.

Florent Cespedes — Analyst

Good afternoon. Florent Cespedes from Bernstein. Two quick questions, please. First, for Houman on Hidradenitis suppurativa.

In fact, next year, first half, you will have three phase 2 trials readout on this — for this indication with three 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 products on the market 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 [Inaudible].

Many thanks.

Paul Hudson — Chief Executive Officer

Thank you, Florent. HS, Houman, and Brian if you have any comment that certainly you can start with.

Houman Ashrafian — Global Head of Research and Development

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 a well-credentialed target of OX40 ligand in this situation as part of our signal seeking lifecycle management strategy with amlitelimab. We have always said that we want to go and buy a better by understanding the targets more clearly and leveraging our internal technologies here, combining TNF, highly validated and OX40 ligand which is preclinically credential, putting those together using our own Ablynx technology, is a nanobody technology gives us an opportunity to serve patients with a BioBetter 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’d like to provide optionality for patients with small molecule.

That’s why 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 finishing.

Paul Hudson — Chief Executive Officer

OK. Great. Thank you very much. I think on Beyfortus.

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

On this 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 third line. Let me be very clear. We have already started to release and distribute Beyfortus 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 foresee in terms of constraints for ’25 and beyond. In addition, I think you are going back to the growth in 2025, a bit too early to give you some sort of 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 2025. Where I do see growth coming down the road is North America increase, I would say, penetration of antibodies but also an increase of Beyfortus in Europe and in the international zones with more countries we’re going to launch into.

Paul Hudson — Chief Executive Officer

Thank you, 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.

Duration: 0 minutes

Call participants:

Thomas Kudsk Larsen — Head of Investor Relations

Paul Hudson — Chief Executive Officer

Francois Roger — Chief Financial Officer

Houman Ashrafian — Global Head of Research and Development

Richard Vosser — Analyst

Thomas Triomphe — Executive Vice President, Sanofi Pasteur

Emily Field — Barclays — Analyst

Brian Foard — Global Business Unit Head, Specialty Care

Graham Parry — Analyst

Seamus Fernandez — Analyst

Jo Walton — UBS — Analyst

Peter Welford — Jefferies — Analyst

Luisa Hector — Berenberg Capital Markets — Analyst

Thibault Boutherin — Morgan Stanley — Analyst

Brendan O’Callaghan — Head of Industrial Affairs

Simon Baker — Analyst

Steve Scala — Analyst

David Risinger — Analyst

Richard Parkes — Analyst

Rajesh Kumar — HSBC — Analyst

Eric Le Berrigaud — Stifel Financial Corp. — Analyst

Roy Papatheodoru — Executive Vice President, General Counsel

Florent Cespedes — Analyst

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