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Sanofi

Q32024

10/25/2024

speaker
Moderator
Investor Relations

Welcome to the Q3 2024 Conference Call for Investors and Analysts. As usual, you can find the slides on tenube.com. Please turn to slide number three. 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 risk and uncertainties that may cause active results to differ materially. We encourage you to read the disclaimer in our slide presentation. In addition, we refer you to our phone 20F on file with the US SEC and our friend's 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 in million euros and for Q3 2024, unless stated otherwise. Please turn to slide number four. 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 ended up keeping the call to about one hour. Q&A, we have Brian, Olivier, Thomas, and Julie to cover the global business, and Roy, our general counsel. For the Q&A, you have two options in Zoom. Raise your hand or submit your question using the Q&A function. With this, I'll now hand you over to Paul.

speaker
Paul Hudson
Chief Executive Officer

Thank you, Thomas. Nicely done. Thank you and hello everyone on the call. We reaffirm strong sales performance this year. The total of Q3 sales of 13.4 billion euro, a 16% increase in CR and estimated 11% excluding the impact of phasing. This robust double-digit growth illustrates the underlying strength of our portfolio. Tupixen continues to be driven by global volume growth across all indications and geographies, now reaching close to 3.5 billion euro in the quarter. Our vaccines business grew 26%. This increase benefited from an element of phasing in flu and Bayforda sales. However, the global rollout of Bayforda has 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. Appella's 8% growth was predominantly driven by the strategic acquisition of QNOL 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 six, Depixen 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 number one 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 euros 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 CAPD 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 redoubts in bullous phantagoid and chronic spontaneous urticaria will also, if approved, create additional near-term growth opportunities. Turning to slide seven, 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 CAGA 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 in the first nine months, our launches have become significant contributors to Sanofi's accelerated top-line growth profile. Bay Fortis leads the way with sales of €645 million 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 €172 million, Altuveo further established its position as the new high efficacy standard of care in haemophilia treatment, demonstrated by patient switches from other factor and non-factor medicines. Other innovative medicines continue to perform well and are contributing to a total of 1.4 billion euro 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 nine, our leading respiratory vaccines have established new standards of efficacy. Beginning with Bay Fortis 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 Bay Fortis 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 in reduction of hospitalization rates This reinforces the real-world effectiveness that Bay Fortis 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 Bay Fortis is currently launched. To summarize, we're on our way to making Bay Fortis 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 flu zone 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. That, and I hand over to Francois, our CFO.

speaker
François
Executive Vice President & 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 opera 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 13.4 billion euros. This performance was partially supported by the early shipments in the flu season and before too 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 mixed effect, partly offset by currency impact, and the obligio 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 efficiencies. 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 one less invoicing than in the U.S. in Q4 versus Q3. Befortus Q4 sales are projected to be in line with their Q3 level, supported by the approved additional industrial capacity. We expect Befortus 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 margins. We confirm our full-year guidance to increase R&D costs by around 700 million euros this year, and we will also marginally increase our investments 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 vaccine franchise is now expected to grow by a high single-digit percentage. Our insulin franchise, more specifically Luntus, 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. Growth margin is expected to decline slightly in Q4 and for the full year due to one-offs last year, such as COVID revenues and Obagio 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 outlook. Turning now to Opela, 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 CDNR to sell a controlling stake of Opela. Sanofi will keep a significant stake in the company to support Opela 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 easy 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 Opela, as this will be a significant investment on our balance sheet. That concludes my presentation. I now hand over to Oman for further positive news on the pipeline. Thanks, Francois.

speaker
Oman
Executive Vice President, Research & Development

We've achieved several milestones this quarter, showing our continuous strong pace of delivery. Tupixent 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 Sarklesa in the U.S. for adult patients with newly diagnosed multiple myeloma ineligible for transplantation. It's the first anti-CD38 with a stator in this setting. Finally, we've shared several positive Phase III readouts, including Tolibrutinib, 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 effort to continually access promising, scientific developments into replenish our pipeline. We invested in Myra GTX with high interest in their technology within immunology and urology. We've invested in Ventix focused in autoimmune and inflammatory disorders with an LRP3 inhibitor in phase two. Another biotech company that piqued our interest focused on immunology with an Aptis Bio with its potential best-in-class phase 2B PD-1 agonist tested in RA and UC and in vitals with our potential best-in-class phase IIb angiotensin II type II receptor agonist in IPF. Lastly, we completed a licensing agreement with Radiomedics and Oranamed for Alphamedics, 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 XTMS conference, we presented tolibrutinib's phase three data in RMS and NR-SPMS. We didn't meet the primary endpoint in the relapsing multivirus study. However, pooled analysis of six-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, tolibrutinib delayed the onset delayed the time to onset of six-month CPP by 31%, with further analysis secondary endpoints showing the number of participants who experienced confirmed disability improvement increased by nearly two-fold, with a significant effect on the lowering of the annualized rate of new or enlarging T2 lesions compared to preceded. Liver enzyme nominations are common to the BTKI class. In our study, 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 tolerabrutinib for SVMS patients, which could offer a first option where no effective treatment helping improve visibility has yet been approved. Turning to amlitilamab, 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 center 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 followed after 16 weeks. Throughout the 68 weeks, animal telomere demonstrated a pleasing safety profile, with most patients reporting PAEs 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. Turability was demonstrated with a sustained percentage of EFI change after amlatilumab cessation. Potential dating interval of up to 12 weeks with a potential for disease modification and therapy-free remission, not seen with any current medicine, is envisioned. All phase three studies in the OCEANA program are ongoing. That's the 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 medicine. Each of these diseases has distinct characteristics leading to the informed use of our medicine in specific progression stages 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 three 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 this. And regrettably, not everything will work. But I am optimistic about this unique pipeline and our core focus 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.

speaker
Paul Hudson
Chief Executive Officer

Well, thank you, Hooman. When I have the call to your questions, as a reminder, we would like to limit your questions to one or two each. We say that every time. I'm not sure anybody hears it, but we'll say it anyway. You'll be notified when your line is open to ask a question. At that time, please make sure you unmute your microphone or option to 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.

speaker
Hooman

Yes, first question from Richard Vosser from J.P. Morgan. Richard?

speaker
Richard Vosser

Hopefully you can hear me. It's Richard Vosser from J.P. Morgan. Two questions, please. First question on Bear Fortis. How are you thinking about the commercial potential beyond this season following the ACIP meeting discussing the Merck Klesvorumab? I can never say it. data this year. Just to continue with that. And then second question is just on the appellate deal. You know, how should we think about the high single digit billion proceeds? How much of that would be realized by debt passed through from appellate, passed down to the appellate? Thanks.

speaker
Paul Hudson
Chief Executive Officer

Thank you, Richard. They force us. It's very easy to say. Toma?

speaker
Thomas Triomphe
Executive Vice President & Global Head of Commercial

I can't say the other one.

speaker
spk00

Yes.

speaker
Thomas Triomphe
Executive Vice President & Global Head of Commercial

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 with when it comes to 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 have two, it will be more than one. to actually sing that song and make sure that more and more babies get protected 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 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 three 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 two products.

speaker
Paul Hudson
Chief Executive Officer

Thank you, Thomas. Francois, Opela deal and proceeds.

speaker
François
Executive Vice President & Chief Financial Officer

Yes, so on the Opela 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 amount. It's equivalent to the disposal of slightly more than 50% stake in the company. We will get the benefit of the debt pushdown 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, we don't expect to get them the earliest in Q2, so it's a little bit early to talk about that. Obviously, the use will be fully in line with our capital allocation policy, which 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 Bolton acquisitions. We are not talking of large acquisitions as evidenced by the fact that we gave some assurance on our intention to retain a double A rating. We will maintain our dividend policy to increase our dividend in absolute value in Euro as we have 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, 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. Thank you. Next question, please.

speaker
Hooman

Yes, next question is from Emily Field from Barclays. Emily?

speaker
spk01

Hi, Emily Field from Barclays. Thanks for taking my question. I'll ask two questions. First one on DIPICS, and I was just wondering, I know it's very early days for the launch in COPD. You know, if you could give us any sort of early metrics about how you're seeing that launch and this new indication and just how you're thinking about the swiftness of the launch card now that you're, you know, 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 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.

speaker
Paul Hudson
Chief Executive Officer

Thank you, Emily. Brian, Doopey, any thoughts on COPD launch?

speaker
Brian
Executive Vice President, Specialty Care

Yeah, 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. 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. 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've talked about before. This is just the beginning of our COPD journey. So we have another pipeline asset as well that's coming directly behind this, and I think the early feedback gives us even more confidence in that and the guidance that we previously provided that the two of those will likely be somewhere in the range of $5 billion a peak.

speaker
François
Executive Vice President & Chief Financial Officer

Okay, on the use of the dilution, let me clarify something first, because I saw some analysis saying that the dilution linked to the separation of Opela was 11%. It is linked to the year 2023. Actually, 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 dilution and the anti-dilution 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 anti-dilution activities that we could go for. So our business EPS will increase, I must just say, 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. Thank you. Next question, please.

speaker
Hooman

Yes. Graham Perry from BOFA. Graham?

speaker
Graham Perry

Great. Thanks for taking my question. Firstly, on Bay Fortress, 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 US, 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 targets? that you have from the board and how much of that is left to execute and independence of Appella 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. Okay, thank you.

speaker
Thomas Triomphe
Executive Vice President & Global Head of Commercial

I mean, Graham, thank you. Yeah, pay for this, countries. Graham, so as we indicated, we launched in 2024 in close to 20 countries, which includes, of course, North America, Western Europe, because markets, of course, last year, you know, whether 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 hemisphere countries that were also disclosed in previous earnings. So most of the current launch has been done in those markets. So really focusing on North America and Western Europe. And there are more markets in which we launch next year.

speaker
Paul Hudson
Chief Executive Officer

Thank you, Thomas. And then to the other part about the buyback. Just as you would imagine, particularly having entered into this period with Apella, 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. Okay, next question.

speaker
Hooman

Yes, next question from Chimus Fernandez from Guggenheim. Chimus?

speaker
Chimus Fernandez

Oh, thanks for the question. So just a couple. First, on your strategy with amlitalimab, 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 timeframe 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. You know, 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.

speaker
Paul Hudson
Chief Executive Officer

Okay, Seamus. Why don't we start with Hooman on aminotelomab and asthma and the OX40 ligand TNF, and then Francois will ask you to comment on the strong tail breathing mixture and the numbers, which I'm unfamiliar with that you mentioned.

speaker
Oman
Executive Vice President, Research & Development

Seamus, thank you for the question. We're more confident than ever about the importance of the 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 a 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 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 amlitilumab will, in due course next year, provide 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. The first is linsecumig, again showing you our community asthma. We look forward to the results of the double punch of blocking TNF and OPS40 in a disease that we know is from a credentialing perspective, influenced by TMS. Both of those results will come in the first half of next year, and we look forward to discussing.

speaker
Paul Hudson
Chief Executive Officer

Thank you, Oum, and yeah, I mean, AD is obviously a huge opportunity for Amitama, but asthma, based on the interval, if we can get there, would be a really great play. Okay, so Francois, strong growth recovery.

speaker
François
Executive Vice President & 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 gross 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 percent 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. Okay, thank you. Next question.

speaker
Hooman

Yes, next question from Joe Walton from UBS. Joe?

speaker
Joe Walton

Thank you. Just to clarify, to confirm that when you present your full year 24 numbers, they'll be on the new basis. So we won't be, at least on the headline basis, seeing the sales of Appella and all the earnings through. That will all be just a single discontinued line item that won't be in your business EPS.

speaker
Paul Hudson
Chief Executive Officer

Absolutely correct, Joe.

speaker
Joe Walton

Excellent. And the other clarification, if you could give us any help on the tax rate that might be expected in FY25, 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 US? Other companies have said that the loss of rebates particularly in immunology because of the loss of the humira rebates has made pbms particularly um uh hard in their negotiations for 2025 for rebates and of course we note that dupixen gets the first sort of proper competitor with ebglis 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 um

speaker
Paul Hudson
Chief Executive Officer

So just to be clear, because we sort of talked as well while you were talking, no appellate in the full year results.

speaker
François
Executive Vice President & Chief Financial Officer

Yes, so that I confirmed already. And maybe, François, I can give you a little bit more color on the tax rate. As you probably saw, with the new scope without appellate, our underlying tax rate will go down from 21% with the form 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 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 a mix of our geographies and activities, we should be able to maintain in 2025 with what we know today. the tax rate to around 20% next year.

speaker
Paul Hudson
Chief Executive Officer

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

speaker
Brian
Executive Vice President, Specialty Care

Yeah, I'm happy to tackle it overall. So first and foremost, Joe, 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, 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 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're 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. Thank you, Brian. Next question, please.

speaker
Hooman

Yes, next question from Peter Wentford from Jefferies.

speaker
Peter Wentford

Hi, thanks so much for taking my question. 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 a Pella 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 three 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 VIRBAC meeting, I think, that's been called 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 three pediatric RSV vaccine currently that is in the clinic. Thank you.

speaker
Paul Hudson
Chief Executive Officer

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

speaker
François
Executive Vice President & Chief Financial Officer

Stranded costs, no, there will be some, but there is nothing material on any stranded costs. By definition, we will have to eliminate them over time. So, I would not be specifically worried about that. 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. Thank you.

speaker
Thomas Triomphe
Executive Vice President & Global Head of Commercial

Thomas, Novavax and PID RSV December meeting. So thanks for the question. So the PID 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 total vaccines, which is currently in phase three, going very strongly with the enrollment, I think we are very well positioned for that field, pending, of course, the phase three outcome. Second point you were mentioning, Novavax, our strategy is absolutely the same as the first day on. We are moving forward to start a phase one, two 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 three assuming phase one, two positive data. Thank you. Next question, please.

speaker
Hooman

Next question from Louisa Hector from Bernberg. Reza?

speaker
spk17

Hi there. Thank you for taking my question. The first one for Thomas is to continue on the flu franchise. How soon do you expect a COVID flu with an ASIC 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 sanity 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 Huma 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? Thank you.

speaker
Paul Hudson
Chief Executive Officer

Okay, woof. A mid-year report, apparently. Okay, so a flu COVID.

speaker
Thomas Triomphe
Executive Vice President & Global Head of Commercial

Yes, thanks for the question, Louisa. 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 start by that because, as you know very well, it's our intention to move the vaccine forward. Now, you also know that there are some competitors that are moving forward on this. Interestingly, Moderna, not to name it, has recognized that they need to provide efficacy data as by the regulator on the flu component. You've seen that they are engaging on a very large phase scale to show if there is or not superiority clinically demonstrated with clinical outcomes. 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 above in the US. 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 through 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 the marketplace and have strong ability to have very good efficacy and very good durability. Will they be there in 2026 or later on? We still need to see the data, which is still not coming.

speaker
Paul Hudson
Chief Executive Officer

Thank you, Thomas. For me, it's an interesting question. 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 as the beginning now of that journey, more proof points, more chances for success rather than failure. But we 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 know, you're as good as your next success or failure. So we've got our heads down. We're doing hard work. I think our internal governances under humans' 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, 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. Okay, next question.

speaker
Hooman

Next question from Thibault Boutrin from Morgan Stanley. Thibault.

speaker
spk04

Yes, thank you. Just a couple of questions on radioliguants. You in-licensed a project for JetNet. There is already a radioliguant 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 Radioligant, if you could comment more broadly on your ambitions here. You also invested in a joint venture with Oranomed. So if you could comment on, you know, 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. your ambitions on the space. Thank you.

speaker
Paul Hudson
Chief Executive Officer

Okay, thank you. Human, 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.

speaker
Oman
Executive Vice President, Research & Development

Yeah, thanks, Paul. I'll start and hand it over to my great colleague, Brendan. 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 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 the 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 over-performing. And in this case, the way this is manifest is in GEPnet. 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 have the right to play and offers superior clinical benefits as well as limiting damage to adjacencies to these GetMets and other tumors. With respect to supply chain, Brendan, I wonder whether you could help. Sure.

speaker
Brendan
Vice President, Radioligand Partnerships

So yeah, getting treatment to patients in a timely, efficient manner obviously is paramount. And in that regard, we're working with Oranamed, 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, taurium-232, available, which we've covered multiple, multiple years. And the process from which we then extract the isotope of interest, which is lead-212, does not, you know, 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 points of treatment, close to major distribution hubs, which will allow us to secure the availability of product within the timelines that are required for treatment. So in summary, we're very, very confident in Oranamed and the provisions they're putting in place.

speaker
Oman
Executive Vice President, Research & 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. And I think we're very proud to be working with this partner.

speaker
Paul Hudson
Chief Executive Officer

Yeah, and I think that on the last point, because it was asked, but you were 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. Okay, next question.

speaker
Hooman

Yes, next question is from Simon Baker from Redburn. Simon?

speaker
Simon Baker

Thank you very much for taking my questions. Two if I may, please. Firstly, on Bay Fortis, could you just remind us where we currently are, where you currently are with capacity and how that will evolve in 2025 and 2026? And then the second question, going back to Apella, I wanted to ask about the influence that BPI France will have. specifically any influence they have beyond their one board seat. Thanks so much.

speaker
Paul Hudson
Chief Executive Officer

Okay. Thank you, Simon.

speaker
Thomas Triomphe
Executive Vice President & Global Head of Commercial

I'm happy for this capacity. Great. There has been a lot of work that has been done by our manufacturing partner and all stakeholders involved. As you know very well, we've added two 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 2025 or 2026.

speaker
François
Executive Vice President & Chief Financial Officer

Okay, thank you. François, come on. On the BPI, so the fact that BPI is joining us shows the of the business case as far as Opela is concerned. Typically, I mean, when you have 1% to 2% shareholding in a company, 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%.

speaker
Paul Hudson
Chief Executive Officer

Okay. Next question.

speaker
Hooman

Next question is from Steve Calla from TD Com. Steve? Yeah.

speaker
Steve

Can you hear me? Yeah. Yeah. Thank you. Does Sanofi have any efficacy data for bifortis, 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 three trials for its 21-valent pneumococcal vaccine this year? and is it still commercially viable given the competitor's 31-valent data?

speaker
Paul Hudson
Chief Executive Officer

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

speaker
Thomas Triomphe
Executive Vice President & Global Head of Commercial

That'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 these 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 if you 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 B42 is compared to Clisrovimab. which I would recommend to look at a couple of points. I would suggest that people look at the available data that are linked 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 computer will need to show the Kaplan-Meyers curves of their Phase III efficacy data, that will show what is the number of new cases and the associated protection in the month of fourth month, fifth month, and sixth month, which will be very different, we believe, than what we have observed with B40s, because we believe that most of the cases in our competitors' phase three 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 years. Thank you. And then you, Mikako. 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 three 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 And the first ever pediatric pneumoconjugate vaccine product with more than 20,000 available on the marketplace. And from that first base, that will already be a 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. Thank you. Very clear.

speaker
Paul Hudson
Chief Executive Officer

Next question, please.

speaker
Hooman

Next question is from .

speaker
spk13

Yes. Can you hear me okay? Yes. Great. So congrats on the financial results. I have two 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 amletelamab efficacy? And then lastly, 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 two data readouts, which will be, you know, important proof of concepts? Thank you.

speaker
Paul Hudson
Chief Executive Officer

Okay. Thank you, David. So comments, human, on OX40 ligand and the sort of the results from Amjad? Yeah, so thanks so much for the question.

speaker
Oman
Executive Vice President, Research & Development

We remain very excited about the OX40 pathway in general. We were very detailed in our credential in the 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 retraining 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. To give you a very simple and clear summary, we think the presence of another molecule, the time raises all boats. It's great to have other players in the atopic dermatitis space because it allows a much greater education of the population. and a greater biopenetration. 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, 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.

speaker
Paul Hudson
Chief Executive Officer

Thank you. Next question.

speaker
Hooman

Next question is from Richard Parks from UNP Exxon. Richard.

speaker
Richard

Hi, thanks very much for taking my questions. Just coming back to Bay Fortis 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 materialise, 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 stay a couple of years ago, you put up slide implying RSV infant market forecast of 2.4 billion by 2030. I'm sure your thinking's evolved since then. So could you just update us on your current thinking over the total commercial potential? Thank you.

speaker
Paul Hudson
Chief Executive Officer

Okay. Thank you for that, Richard. So bait for this market, how's it going to develop?

speaker
Thomas Triomphe
Executive Vice President & Global Head of Commercial

No significant change on our RSV overall market. anticipation for 2030. You also notice, though, that on top of the RSV newborn, there will be the RSV infant, the so-called RSV toddler 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 competitors, let me be very clear. I might have missed it in the first time, but With or without competitors, 2025 will be a year of growth for B4-2s. 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 other. 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 a competitor. And therefore, with or without a competitor, Bay Fortress will grow in 2025.

speaker
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. Okay, next question, please.

speaker
Hooman

Next question is from Rajesh Kumar from HSDC.

speaker
Rajesh Kumar

Hi, thanks for taking my question. Another one on Bay Fortis versus Klesrovimab. When, you know, 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. 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.

speaker
Paul Hudson
Chief Executive Officer

Okay, thanks, Raj. They forwarded stocking.

speaker
Thomas Triomphe
Executive Vice President & Global Head of Commercial

Yeah, so the matter on those, I'm coming back to that in a second, Rajesh, but as you started to have in your question, indeed, it's two monoclonal antibodies that are both targeting RSD, but there are significant differences. I think the coming ACIP meeting will be very interesting to highlight those. First and foremost, Bayfortus has demonstrated RSD protection in the real world and had 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, again, RSV, medically attended, LRT disease, with the usual caveat, of course, that when you're comparing across trials, you've seen that BESR2 has shown a higher efficacy estimate point around 75% versus Clifcovimab at 60%. I do believe it's important because while we absolutely want to make sure that we prevent 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 have with Veportuse 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. 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 cascomimab 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, having 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 those doses in the hospital channel or within a maternity setting. On the other end, 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 setup. So each channel has a very well-corresponding specific dosage that goes very well. And finally, on the dosage point, I think it might 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. I think we have good arguments on those points, too. Thank you very much, François.

speaker
François
Executive Vice President & Chief Financial Officer

Yes, on the tax, now on the amount of cash that we will receive at the earliest in Q2 2025 for Opelaz, we're going to find it's a high single-digit number in billions of euros, net of tax, net of any other costs, such as transaction costs as well. This is really a net chance policy that we will get at the earliest in the future.

speaker
Paul Hudson
Chief Executive Officer

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

speaker
Hooman

Yes. Next question is from Eric Le Berrigo from CIFOL. Eric.

speaker
Eric

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 the BigSense 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 off to peak cent. 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 when can we expect some phase two updates on that specific asset? Thank you. Okay.

speaker
Paul Hudson
Chief Executive Officer

Thank you. Roy, over to you on Dupuy loss of exclusivity.

speaker
Roy
General Counsel & Corporate Secretary

So the Dupuy compound patent 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.

speaker
Paul Hudson
Chief Executive Officer

Okay. Thank you, Roy. And our strategies are, you know, internal because, of course, lots of people are interested in which way we decide to go. Okay. And then, Huma, anti-TL1A? Briefly, thanks for the question.

speaker
Oman
Executive Vice President, Research & Development

As you've seen in the deck, Duvacutib, as it's now known, and the RNTTL1A 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.

speaker
Paul Hudson
Chief Executive Officer

Okay, thank you. And I think it may be the last question, so it's not...

speaker
Hooman

Yes, last question from Florent Cespedes from Bernstein.

speaker
spk06

Good afternoon, Florent Cespedes from Bernstein. Two quick questions, please. First, for women on hydrodinitis suppurativa. In fact, next year, first half, you will have three phase two trials. We'll read out on this for this indication with three different kinds 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 on the market are quite successful. So some thoughts on this would be great and also in terms of potential of this market. And my second question is for Thomas. It's a follow-up on before too. So I was just wondering if we could have a little bit more color about manufacturing capacity 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 to quantify this. Many thanks.

speaker
Paul Hudson
Chief Executive Officer

Thank you, Florent. HS, Koeman and Brian, if you have a comment that you can start with.

speaker
Oman
Executive Vice President, Research & Development

Yeah, Florent, thank you 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 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 use the well-credentialed target of oxfoli ligand in this situation as part of our signal-seeking and life cycle management strategy with amlitilumab. We have always said that we want to go by and better by 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 biobatter as well as the anti-TNF, which is already on the market, and amlitilamab. 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 in small molecule. That's why our IRAC4 degrader, which we work very closely with our partner, gives us further optionality in this space. And we look forward to seeing what the data in this space shows. So when we think about HS, we think about franchises, we think about stratification, or we think about optionality to ensure that we serve the whole strata of every patient.

speaker
Paul Hudson
Chief Executive Officer

OK, great. Thank you very much. I think on Bay Fortis.

speaker
Thomas Triomphe
Executive Vice President & Global Head of Commercial

On Bay Fortis 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 Bay Fortis 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 2025 and beyond. In addition, I think you are 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 a 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 a North America increase, I would say penetration of non-contributives, but also an increase of B40s in Europe and in the international zones with more countries we're going to launch into.

speaker
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 CERF. 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.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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