Sanofi Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
October 25, 2024

There are 24 speakers on the call.

Operator

can find the slides on cenuvi.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 are subject to substantial risks and uncertainties that may cause actual results to differ materially. We encourage you to read the disclaimer in our slide presentation.

Operator

In addition, we refer you to our Form 20 F on file with the U. S. SEC and our France 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 €1,000,000 and for Q3 2024, unless stated otherwise.

Operator

Please turn to Slide 4. First, we have a presentation, then we'll take your questions. As last time, we kept the presentation on the shorter side to allow for more questions and we aim at keeping the call to about 1 hour. Q and A, we have Brian, Olivier, Thomas and Julie to cover the Global Business and Roy, our General Counsel. For the Q and A, you have two options in Zoom.

Operator

With this, I'll now hand you over to Paul.

Speaker 1

Thank you, Thomas. Nicely done. Thank you, and hello, everyone, on the call. We reaffirmed strong sales performance this year with a total of Q3 sales of €13,400,000,000 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.

Speaker 1

Dupixent continued to be driven by global volume growth across all indications and geographies, now reaching close to €3,500,000,000 in the quarter. Our Vaccines business grew 26%. This increase benefited from an element of phasing in flu and Bay Fortis sales. However, the global rollout of Bay Fortis provided a strong contribution as well. Our pharma launches have been performing very well with a 67% increase in sales.

Speaker 1

This is a result of strong performance across all 8 medicines that we have recently launched and a clear illustration of the value those medicines bring to healthcare systems and patients. APELLA's 8% growth was predominantly driven by the strategic acquisition of Cunol in the U. S, which has bolstered our presence in the consumer health care market. That is why with confidence that we have once again raised our business EPS guidance for 2024 on Monday, this reflects our continued momentum and our commitment to delivering value to our stakeholders. On Slide 6, Dupixent delivered another quarter of strong growth.

Speaker 1

It also reached the major milestone of improving the lives of more than 1,000,000 patients currently on treatment around the world across approved indications, age groups and geographies. DUPIXENT continues to hold the number 1 unibrand 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.

Speaker 1

This remarkable performance reinforces our confidence in our sales ambition of around €13,000,000,000 for the full year 2024. The recent consecutive approvals of the COPD indication in the U. S. And China, on the heels of the EU approval 4 months ago, speaks volumes of our ability to move decisively, execute and meet the need for more treatment options. The expansion of Dupixent COPD will give hundreds of thousands of additional patients who are living with this devastating disease the chance of potentially improved breathing and a life with fewer exacerbations.

Speaker 1

Additional positive Phase III readouts in bullous femtogoid and chronic spontaneous urticaria will also, if approved, create additional near term growth opportunities. Turning to Slide 7. We will continue to execute on the 3 commercial levers that will propel Dupixent's volume demand and its growth longer term. First, the steady increase in the penetration of advanced therapies within the biologic eligible patient population. New market entrants of other biologics are expected to help drive market growth through improved awareness and adoption second, the geographic expansion with around 30 potential country launches across existing indications by 2026 3rd, the expansion into new indications with high unmet need for large biologic eligible patient populations like COPD and CSU.

Speaker 1

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 2,030 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.

Speaker 1

With almost €3,000,000,000 in the 1st 9 months, our launches have become significant contributors to Sanofi's accelerated top line growth profile. Bay Fortis leads away with sales of €645,000,000 in Q3, showing an exceptional market uptake in its 2nd season and underscoring the critical role it plays in all infant protection. With sales of €172,000,000 Altuveo further established its position as the new high efficacy standard of care in hemophilia A treatment, demonstrated by patient switches from other factor and non factor medicines. Other innovative medicines like Nexviozyme, Resorog and Sarclisa continue to perform well and are contributing to a total of €1,400,000,000 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.

Speaker 1

Moving to Slide 9. Our leading respiratory vaccines, Bayfordis and Fluzone High Dose, have established new standards of efficacy. Beginning with Bayfordis on the left side, we continue to build an outstanding body of evidence to further strengthen our position as market leader in oral infant protection. A recent study demonstrates that BayFortis continues to protect infants against RSV hospitalization over a full 6 month duration without waning efficacy. Furthermore, in the U.

Speaker 1

S, real world evidence showed an 87% efficacy and reduction of hospitalization rates. This reinforces the real world effectiveness that Bayfordis 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 BayFortis is currently launched. To summarize, we're on our way to making BayFortis 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.

Speaker 1

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 Fair Wage Network, which guarantees wages above local benchmarks.

Speaker 1

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.

Speaker 2

Thank you, Paul. Good morning and good afternoon to all. Before I start, let me clarify that financials for these quarters include operator 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 €13,400,000,000 This performance was partially supported by the early shipments in the flu season and therefore too strong momentum.

Speaker 2

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 and L. Gross margin improved by a full percentage point in the quarter, driven by a positive mix effects, partly offset by currency impact on the ObAgio loss of exclusivity.

Speaker 2

Higher R and D expenses are aligned with our committed increase for 2024, reflecting our continued investment in innovation. SG and 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.

Speaker 2

Do remember that there is one less invoicing there 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 €1,500,000,000 in 2024, a remarkable performance in its 1st full year of marketing.

Speaker 2

For Q4, please remember that we had around €400,000,000 of 1 off COVID revenues in Q4 2023 as well as the associated margin. We confirm our full year guidance to increase R and D cost by around €700,000,000 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 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.

Speaker 2

We expect divestments to reduce sales by about €300,000,000 in 2024, and we anticipate capital gains from divestments to be around €400,000,000 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 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.

Speaker 2

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 €16,000,000,000 EV is very attractive.

Speaker 2

The 14 times 2024 estimated EBITDA is equivalent to the trading multiples of industry peers. We expect the transaction to close in the Q2 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.

Speaker 2

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 Uman for further positive news on the pipeline.

Speaker 3

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 US and China where COPD is a huge unmet medical need due to widespread smoking in the local population. Another great milestone is the approval of sarclisa in the US for adult patients with newly diagnosed multiple myeloma ineligible for transplantation. It's the first anti hulie38 with this data in this setting.

Speaker 3

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 Myra GTX with high interest in their technology within immunology and neurology. We've invested in Ventix focused in autoimmune and inflammatory disorders with an LRP3 inhibitor in Phase 2. Another biotech company that piqued our interest focused on immunology was Anapetus Bio with its potential best in class Phase 2b PD-one agonist tested in RA and UC and in Vicol with our potential best in class Phase 2b angiotensin II Type II receptor agonist in IPF.

Speaker 3

Lastly, we completed a licensing agreement with Radiometics and OranoMed 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 XTRIMS conference, we presented tolebrutinib Phase III data in RMS and R SPMS. We didn't meet the primary endpoint in the relapsing multiple sclerosis study. However, pooled analysis of 6 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.

Speaker 3

In SPMS, Toll Britain delayed the onset to on delayed the time to onset of 6 month CDP by 31%, with further analysis of secondary endpoints showing the number of participants who experienced confirmed disability improvement increased by nearly twofold, with a significant effect on the lowering of the annualized rate of new or enlarging T2 lesions compared to placebo. Liver enzyme animations are common to the BTKI class. In our studies, most cases resolved without sequelae. They all occurred in the 1st 90 days. Accordingly, we focused our intense liver monitoring in that period.

Speaker 3

I'm confident in tolebrutinib for SBMS patients, which could offer a first option where no effective treatment helping improve disability has yet been approved. Turning to amlutilumab, our OX40 ligand inhibitor molecule, we recently presented new Phase IIb atopic dermatitis data from the 68 week STREAM AD study at the EADV conference. The study had 3 parts. The first one, the primary endpoint percentage change in EASI was met at 16 weeks, followed by a second pump 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, enamrilatinib demonstrated a pleasing safety profile with most patient reporting TAEs 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.

Speaker 3

Durability was demonstrated with a sustained percentage of EFSI change after amlutilumab 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, 3 dots are planned in 2026. The objective of the next slide is to present our work in immunology to the community where we present the breadth of our immunology portfolio, where we persist with innovation to serve patients' needs. We're increasingly focused across all stages and grades of diseases and patients we serve, which are being addressed by approved in development medicines.

Speaker 3

Each of these diseases has 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 and D productivity that keeps on delivering. We plan 6 Phase 3 readouts, 11 submissions and 10 regulatory positions in multiple countries and we look forward to keeping you updated on progress. We are humble in the face of disease and regrettably not everything will work.

Speaker 3

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 and D productivity and the quality of our pipeline over time. With this, I hand back to Paul for Q and A.

Speaker 1

Well, thank you, Hooman. We'll now open the call to questions. As a reminder, we would like to limit your questions to 1 or 2 each. We say that every time. I'm not sure anybody hears it, but say it anyway.

Speaker 1

You'll be notified when your line is open to ask a question. Now we take the first question, please. Go ahead.

Speaker 4

Yes. First question from Richard Vosser from JPMorgan. Richard?

Speaker 5

Hopefully, you can hear me. It's Richard Vosser from JPMorgan. 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, clasvoramab, I can never say it, data this year, Just to continue with that.

Speaker 5

And then second question is just on the Appellate deal. How should we think about the high single digit $1,000,000,000 proceeds? How much of that would be realized by debt pass through from a pass through pass down to a pillar? Thanks.

Speaker 1

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

Speaker 6

No, I can't say the other one neither. 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 when it comes to Merkel anti polypunitization.

Speaker 6

So we really welcome, that there is more players to come because it will increase the size of the playfield basically. What is very important is that monoclonal antibodies have shown they are the only pathway to be able to really protect all infant. And if we are to, we'll be more than one 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 to, they were showing still some important differences between the two product. It's still early data for our competitors.

Speaker 6

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 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 1

Thomas? Francois, Opela deal and proceed.

Speaker 2

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 1,000,000,000 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.

Speaker 2

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, which is essentially around investing in our business, which is already what we do. On the M and A side, we keep on looking at opportunities in the market. We are talking essentially on bolt on acquisitions.

Speaker 2

We are not talking of large acquisitions, as evidenced by the fact that we gave some assurance on our intention to retain a double layer ratio. We will maintain our dividend policy to increase our dividend in absolute value in euros, as we have always done already done over the last 30 years. And we will obviously look at anti dilutive share buybacks. We heard loud and clear 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.

Speaker 2

Thank you. Next question, please.

Speaker 4

Yes. Next question is from Emily Field from Barclays. Emily?

Speaker 7

Hi. Emily Field from Barclays. Thanks for taking my question. I'll ask 2. First one on Dupixent.

Speaker 7

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 card 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 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.

Speaker 7

Thank you.

Speaker 1

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

Speaker 8

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, 3rd leading cause of death worldwide. No new meaningful innovation in the past 10 years.

Speaker 8

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.

Speaker 8

So we've got another pipeline asset as well that's coming directly behind this. And I think the early feedback gives us even more confidence in that in the guidance that we previously provided that the 2 of those will likely be somewhere in the range of 5,000,000,000 a peak.

Speaker 2

Okay. Yes. Milley, 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 Opelae was 11%. It is linked to the year 2023. For 2024, it will be closer to 9%, given that our biopharma business has grown quite a lot in the meantime.

Speaker 2

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, in at constant exchange rate, will increase in 2025 over 2024. And it will increase over 2024 even with or without Opelon. So the dilution will be anywhere even before anti dilution activities will be absorbed.

Speaker 1

Thank you. Next question, please.

Speaker 4

Yes. Graham Perry from Roufah. Graham?

Speaker 9

Great. Thanks for taking my question. So firstly, on BAPORT, just wondered of the €1,500,000,000 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.

Speaker 9

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 and independence of Appelo 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.

Speaker 1

Okay. Thank you. I mean, Graham, thank you. Yes, Pay Fortis countries? Graham,

Speaker 6

so as we indicated, we launched in 20 24 in close to 20 countries, which includes, of course, North America, Western Europe, because market, of course, last year, we do know whether we're going to relaunch in Spain, in France, but we expanded to various markets, including and we talked about it in the past before, that includes part together, that includes Germany, that includes Italy, that includes Belgium and a few others. And we had a couple of South Hemisphere countries that we also have disclosed in previous earnings. So most of the, I would say, current launch has been done in those markets. So really focusing in North America and Western Europe. And there are more markets in which we'll launch next year.

Speaker 1

Thank you, Thomas. And then to the other part about the buyback. Just as you would imagine, particularly having entered into this period with Appellate, 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 4

Yes. Next question from Thomas Vermundes from Guggenheim. Thomas?

Speaker 10

Thanks for the question. So, just a couple. First on your strategy with amlutelimab, just wanted to get a better sense of, the importance of asthma in that, dataset? 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, you know, 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.

Speaker 10

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 Opela 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 1

Okay, Seamus. Well, why don't we start with Hooman on amlutelimab and asthma and the X4D ligand TNF? And then Francois asked you to comment on the strong recovery for next year and the numbers which I'm unfamiliar with that you mentioned.

Speaker 3

Seamus, thank you for the question. We're more confident than ever about the importance of the OX40 OX40 Ligand pathway in disease as you've seen from our data in atopic dermatitis. We feel that we are best in class by virtue of targeting the ligand, which gives us biological distinction both from a durability and efficacy perspective, but also from a safety perspective to mitigate for example chills and other impacts. Specifically with respect to asthma, OX40 ligand is 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.

Speaker 3

We are committed to the asthma franchise and we hope that emilotilumab 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 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 to do in 2nd MIG, again showing you our human asthma. We look forward to the results of the double punch blocking TNF and OX40 and a disease that we know is, from a credentialing perspective, influenced by TNF and OX40.

Speaker 3

Both of those results will come in the first half of next year, and we look forward to discussing.

Speaker 1

Thank you, Hooman. Yes, I mean, AD is obviously a huge opportunity for amelizumab. But asthma, based on the interval, if we can get there, would be a really great play. Okay. So Francois, from this growth recovery.

Speaker 2

Yes. And foremost, what is important to understand is exactly what you said, which is with Sanofi

Speaker 11

as

Speaker 2

a pure biopharma company, we'll have a better growth profile and margin profile as without Opelar. 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 2020 for our business EPS. We revised our guidance upwards twice at the end of Q2 and just now and at the end of Q3.

Speaker 2

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.

Speaker 4

Okay. Thank you. Next question? Yes. Next question from Jo Walton from UBS.

Speaker 4

Jo?

Speaker 12

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 the headline basis, seeing the sales of Appellate and all the earnings through. That will all be just a single discontinued line item that won't be in your business EPS?

Speaker 2

Through the collector, Joe.

Speaker 12

Excellent. And the other clarification, if you could give us any help on the tax rate that might be expected in FY 'twenty five, 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, you 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 hard in their negotiations for 2025 for rebates.

Speaker 12

And of course, we note that Dupixent gets the 1st sort of proper competitor with Eblis 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.

Speaker 1

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

Speaker 2

Yes. So that I confirmed already. And maybe Francois speaking. I can give you a little bit more color on the tax rate. As you probably saw with the new scope without Opelar, our underlying tax rate will go down from 21% with the strong scope to about 20% with the new scope.

Speaker 2

I want to mention as well that with the new tax laws in France, we do expect an increase of 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.

Speaker 2

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.

Speaker 1

Thank you, Francois. And maybe, Brian, you want to respond to the RA question?

Speaker 8

Yes. I'm happy to tackle it overall. So first and foremost, Joe, I think as from an environment standpoint, the Inflation Reduction Act, there's a couple of things

Speaker 11

in there.

Speaker 8

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. Ability to spread that across the months could potentially allow these patients to have access to medicines that they haven't had before in the past and we think that that's a good thing. So that's a positive side of things. From an IRA standpoint, our portfolio actually lends us very well to this because we have an innovative portfolio, we have an innovative pipeline coming and that's what we see is the UDS marketplace really values innovation.

Speaker 8

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. 1st and foremost, we have great underlying demand growth.

Speaker 8

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

Speaker 11

a good position. And this is all taken into

Speaker 8

our guidance as we've provided to you for $13,000,000,000 this year as a target or around $13,000,000,000 and a double digit CAGR growth from $23,000,000 through 2,030.

Speaker 1

Thank you, Brian. Next question please.

Speaker 4

Yes. Next question from Peter Wentford from Jefferies.

Speaker 1

Peter?

Speaker 13

Hi. Thanks very much for taking my questions. 2. 1, 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.

Speaker 13

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 III trials for new vaccines. And I guess the question here is, first of all, with the Novavax and the deal you've done for the combination flu, would your intention be to run an efficacy study as you talked about for that?

Speaker 13

And similarly, there's an FDA VIRBAC meeting, I think, that's been called on the 12th 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.

Speaker 1

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

Speaker 2

Yes. Stranded costs, no, there will be some. But it's there is nothing material on any stranded costs by definition. We will have to eliminate them over time. So would not be specifically worried about that.

Speaker 2

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.

Speaker 1

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

Speaker 6

Yes. So thanks for the question. So the PD RSV meeting that was called for, you probably have seen the invitation, is 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 todial vaccines, which is currently in Phase 3, doing very strongly with the enrollment, I think we are very well positioned for that field pending, of course, the Phase 3 outcome.

Speaker 6

2nd point you were mentioning, Novavax, Our strategy is absolutely the same as the first day on. We are moving forward to start a Phase onetwo this year where we want to showcase that we can do outflow with Novavax COVID-nineteen together in a combination vaccine that does not compromise neither on safety nor on efficacy. And our intention is once we have results, if positive, we will immediately move next year towards Phase III by assuming Phase onetwo positive data.

Speaker 4

Next question from Luisa Hector from Berenberg. Luisa?

Speaker 14

The first one for Thomas, just to continue on the flu franchise. How soon do you expect a COVID flu with an ACIP recommendation to be on the market? And then second question is for Paul. 5 years, well done. So you've made enormous progress transforming the Sanofi business.

Speaker 14

But looking forward, R and D is the outstanding challenge. So what or when do you see as the most critical inflection points for determining progress in the R and D transformation? And how is the organization positioned to really maximize on pipeline successes, but as Huwman 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 1

Okay. My mid year report apparently. Okay. So a flu COVID, Asap?

Speaker 6

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 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 know that I can move forward.

Speaker 6

Now you also know that there are some competitors that are moving forward on this. Interestingly, Moderna has recognized that they need to provide efficacy data asked by the regulator on the flu component. You've seen that they are engaging on a very large face rescale to show if there is or not superiority clinically demonstrated with clinical outcome against standard of flu. And I think it's going to be very important because you need to demonstrate clinical statistically meaningful superior efficacy versus standard dose to have a chance to be in the ACIP recommendation for 65 and above in the U. S.

Speaker 6

So let's put things first in order. First, we need to see what is the efficacy bar they can pass with their product. 2nd, 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 the marketplace and have shown strong ability to have very good efficacy and very good tolerability.

Speaker 6

Will they be there in 2026 or later on? We still need to see the data, which is still not coming.

Speaker 1

Thank you, Tom. 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 and D turnaround. And it was sort of 5 to 7 years was the average if you look at some of the success stories. You know me a little bit now, and I'd like to have been faster.

Speaker 1

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 'twenty four and 'twenty five were going to be important years for really seeing how far we have come.

Speaker 1

Now of course, internally, we can be optimistic, but we're never far from people saying 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 governance is under Hooman'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.

Speaker 1

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 towards R and D. So too early to say, I guess.

Speaker 1

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. Okay, next question?

Speaker 4

Next question from Thibault Boutran from Morgan Stanley. Thibault?

Speaker 11

Yes, thank you. Just a couple of questions on the high yield grants. You in licensed projects for JetNet. There is already a highly relevant syndication. So just wonder if you could comment on the positioning versus the standard of care and what you think you can achieve here.

Speaker 11

And second question still related to highly relevant. If you could comment more broadly on your ambitions here, You also invested in the in the joint venture with 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 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 for this, how it's handled between you and your partner and and, yeah, your, your ambition on the, on the space.

Speaker 11

Thank you.

Speaker 1

Okay. Thank you. Human, radio ligand, is it a one off? What drew us to it? And what about supply chain?

Speaker 1

And maybe Brendan has a view on that? I don't know.

Speaker 3

Yeah thanks Paul, I'll start and hand it over to my great colleague Brendan. So simple question, the radio, 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. LED-two twelve is a particularly interesting modality, is 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 LED-two twelve, 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 GEP NET, the led-two twelve 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.

Speaker 3

So the beauty of this opportunity is it knits together many of the areas in which we are uh-uh we have the right to play, and offer superior clinical benefits as well as limiting damage to adjacencies to these GAT nets and other tumors. With respect to supply chain, Brendan, I wonder whether you can help.

Speaker 1

Sure.

Speaker 15

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 Torium-two thirty two available which will cover multiple, multiple years. And the process from which we then extract the isotope interest, which is led-two twelve does not it's a very robust chemical process, does not rely on nuclear reactors or particle accelerators or any complex technology like that. So we're quite confident in their ability to secure a seamless supply chain.

Speaker 15

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 Orenomib and the provisions they're putting in place.

Speaker 3

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 1

Yes. 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 4

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

Speaker 16

Thank you very much for taking my questions. 2, 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 Appella, I wanted to ask about the influence that BPI France will have, specifically any influence they have beyond their 1 board seat? Thanks very much.

Speaker 1

Okay. Thank you, Simon. That big forward is capacity.

Speaker 6

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 2 filling lines up and running and we're going full speed. So with the 20 markets we just launched in 2024, we don't see any capacity limitation and we'll grow that supply for next year and the year after to make sure that there will be again no supply constraints anticipated at all in 2025 or 2026.

Speaker 1

Okay. Thank you. Franck, you're going to comment. On the

Speaker 2

BPI, so the fact that BPI is joining us shows the attractiveness of the business case as far as Opera is concerned. Typically, I mean, when you have 1% to 2% shareholding in a company, I mean, the governance attached to it is relatively limited. So this is a classical this is what happens in that case. It's in line with market practice for a stake of around 1% to 2%.

Speaker 1

Okay. Next question?

Speaker 4

Yes. Next question is from Steve Kala from TDQM. Steve?

Speaker 3

Steve, do

Speaker 1

you have a bit?

Speaker 17

Can you hear me?

Speaker 1

Yes. Thank

Speaker 17

you. Does Sanofi have any efficacy data for Bifortis, which supports protection through 6 months? And what percent of RSV cases fall between 5 6 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?

Speaker 17

And is it still commercially viable given the competitors' 31 valent data?

Speaker 1

Thank you, Steve. Excellent questions. Thomas, on durability? It's a great question.

Speaker 6

First of all, do we have data over 6 months? Absolutely. And we made the reference in a slide that is today in today's 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 6 months.

Speaker 6

We still see 83% efficacy against hospitalization after 6 full months and we are very confident that we have kept running for another data points after that. The efficacy will still go very well. So I actually believe that duration of protection is significantly in favor of Bifortus compared to kezorimab, 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 product where you see a significant difference. One is above 40 days, the other one is above 70 days, half life.

Speaker 6

So a significant difference between both product. And I remind also everyone that for the coming ACIP discussions, our computer, we need to show the Kaplan Meier's curves of the Phase 3 efficacy data that will show what is the number of new cases and the associated protections in the month of 4th month, 5th month and 6th month, which will be very different we believe than what we have observed with Bifortus because we believe most of the cases in our competitor Phase 3, we're 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

Speaker 1

few years. And Pneumococcal?

Speaker 6

And on PCV21, thank you very much because it's a very important product for our pediatric portfolio. We are fully on track to start Phase III in 2024. I confirm that. And the next part of your question was, is it a viable product? Absolutely.

Speaker 6

And you fully understand that our goal is not just to do the facility in 2021 stop and that's it. Our goal is to have the first and the first ever pediatric non conjugate vaccines product with more than 20 available on the marketplace. And from that first base that will already be the 1st milestone then we will be further with additional cell types. So we will once you're in that race, you

Speaker 1

always want to remain competitively. Thank you.

Speaker 4

Very clear. Next question, please. Next question is from David

Speaker 11

Risingeroy. David?

Speaker 18

Yes. Can you hear me okay?

Speaker 11

Yes.

Speaker 18

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 amlatelimab efficacy? And then sorry about the noise.

Speaker 18

2nd, Sanofi has several I and 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.

Speaker 1

Okay. Thank you, David. So comments human on OX40 ligand and the sort of the results from Anja?

Speaker 3

Yes. So, thank you so much for the question. We remain very excited about the OX40 pathway in general. We were very detailed in our credentialing this target before we went into the space and all the publicly available data to support an even stronger perspective on the importance of the OX40 pathway. However, the differentiation of the OX40 receptor versus the ligand may be manifest in the data that's come from Amgen.

Speaker 3

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 a 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. That to give you a very simple and clear summary, we think the presence of another molecule, the tide raises all boats, it's great to have other players in the atopic dermatitis space because it allows a allows a much greater education of the population and a greater biopetration, however I think targeting the Ligand has now been shown to be a better more effective intervention, and extremely quickly to your second question, you are right, we are blessed to have a number of very significant readouts coming out in the next year, we will focus on presenting and disclosing our results in the appropriate form, most of which will be in scientific congresses. We are however deeply conscious of our compliance responsibilities and our responsibilities to the street and if they are material of course we will hasten to convey them to the street as quickly as possible.

Speaker 1

Thank you. Next question.

Speaker 4

Next question is from Richard Parks from UMP Exane. Richard.

Speaker 19

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 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 stay a couple of years ago, you put up slide implying RSV infant market forecast of 2,400,000,000 by 2,030.

Speaker 19

I'm sure your thinking has evolved since then. So could you just update us on your current thinking over the total commercial potential?

Speaker 1

Okay. Thank you for that, Richard. So Bay Forest market, how is it going to develop?

Speaker 6

No significant change on our RSV overall market anticipation for 2,030. You also noticed, though, that on top of the RSV newborn, there will be the RSV infant IRR, the so called RSV toddler vaccines coming down the road for kids to be protected at age 1 and above. So that will of course be a very interesting 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, but I might have missed it in the first time. But with or without competitors, 2025 will be a year of growth

Speaker 15

for the Portuguese.

Speaker 6

Again, there is a significant number of new brands 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 healthy 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 methanol immunization. That's why it's very good to have further voices pushing on all infant protection.

Speaker 6

The playing field will increase with or without a competitor and therefore with or without a competitor before just we move in 2025.

Speaker 1

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 4

Next question is from Rajesh Kumar from HSBC.

Speaker 20

Hi, thanks for taking my question. Another one on Bifortus versus chlestrovimab. 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 bodyweight infants? And how can you ensure that doesn't become a significant disadvantage for you?

Speaker 20

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 Opela. 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 1

Okay. Thanks, Raj. They've fought us stocking.

Speaker 6

Yes. So the matter on those, I'm coming back to that in a second, Rajesh. But as you started to have in your questions, indeed, it's 2 monoclonal antibodies now both targeting as these but there are significant differences. I think the coming SAP meeting could be very interesting to highlight those. 1st and foremost, before this as demonstrated the protection in the real world and it's been studied in more than 75,000 infants.

Speaker 6

That's a very significant number of kids showing a very high bar of efficacy. 2nd 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 Bifertus has shown a higher efficacy estimate points around 75% versus 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 outcome, we also want to make sure and I'm sure parents want to make sure that they can increase their chance of not missing 12 or 3 days of work in order to have to bring their newborn at multiple doctors visits. So I think that we have with the produce a product that has shown efficacy against both severe and less severe outcomes. And finally, the safety profile is a very important point.

Speaker 6

This is the new born 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 casolomimab is a significant differentiator? Actually, we don't think this is an issue at all. First of all, because we thought a lot about this, having 2 doses or 2 dosages should I say is important because the right dose is fitting the right channel.

Speaker 6

The smallest babies typically at newborn time are weighing less than 5 kilograms, they should receive a 50 milligram dose. These babies usually do get those doses in the hospital channel or within a maternity setting. On the other hand, babies that are weighing more than 5 kilograms should receive 100 milligram dose which are normally older babies but get it within the pediatrician clinic setups. So each channel has a very well corresponding specific dosage that goes there. And finally on the dosage point, I think it's going to be very interesting for doctors to see that our findings in clinical studies is that 50 milligram doses for our product for newborns is exactly the right choice as it delivers the best efficacy with the smallest possible dose for new born babies.

Speaker 6

I think we have good arguments on the point too.

Speaker 1

Thank you very much, Francois.

Speaker 2

Yes, on the tax, not on the amount of cash that we will receive at the earliest in Q2, 2025 for Opelas, we confirm it's a high single digit number in 1,000,000,000 of euros net of tax, net of any other cost such as transaction cost as well. So this is really a net charge policy that we will get at the earliest in Q2.

Speaker 1

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

Speaker 4

Yes. Next question is from Erik Huberico from CIFO. Erik?

Speaker 21

Yes. Thank you. Good afternoon. Two questions. First, in recent interactions with investors, it looks like there's a topic that come through more often around Dupixent LOE extension.

Speaker 21

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 when can we expect some Phase 2 update on that specific assets? Thank you.

Speaker 1

Okay, Eric. Thank you. Roy, over to you on GP loss of exclusive.

Speaker 22

Sure. The Dupixent compound patent expires in the U. S. In March 2031. This is the patent term extended expiration date.

Speaker 22

In Europe, it's March 2033, which is the SPC extended expiration date with pediatric exclusivity, which is in the process 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 US 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 the PIKSON at this stage.

Speaker 1

Okay. Thank you, Roy. And our strategies are internal because, of course, lots of people are interested in which way we decide to go. Okay. And then Hooman, antitill1a.

Speaker 1

Briefly, thanks

Speaker 3

for the question. As you've seen in the deck, duvacitel, as it's now known, antitill1a 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 1

Okay. Thank you. And I think it may be the last question for the floor.

Speaker 4

Yes. Last question from Florent Cespedes from Bernstein.

Speaker 23

Good afternoon. Florent Cespedes from Bernstein. Two quick questions, please. First, for human on heidradenitis, in fact, next year, first half, you will have 3 phase 2 trials. We read out on this, on this and before the syndication with 3 different runs mechanism of action.

Speaker 23

We're just wondering if you could give us a little bit more color on your strategy on this population as you have already, you price 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 before too. So I was just wondering if we could have a little bit more color about manufacturing capacities for, for 2025. Is there a third, manufacturing line that will be ready next year?

Speaker 23

And when you mentioned Thomas that there will be growth in 2025, or we're just wondering if you could give us a little bit more color on this, if you can't refinance. Many thanks.

Speaker 1

Thank you, Florent. HS, Kooman and Brian, if you have a comment, but certainly who needs to start with.

Speaker 3

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'll know I was involved with the 1st 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.

Speaker 3

In this case, we used a well credentialed target of oxfordly ligand in this situation as part of our signal seeking a life cycle management strategy with amlutilumab. We have always said that we want to go and buy and better by understanding the targets more clearly and leveraging our internal technologies, here combining TNF, highly validated, and OX40 Ligand, which is pre clinically credentialed, putting those together using our own ablibs technology, the nanobody technology, gives us an opportunity to serve patients with a bio batter as well as the anti TNF which is already on the market and amlutelumab and then moving one step forward, we've always expressed a view that as well as antibodies we'd like to provide optionality for patients in small molecule that's why IRAC4 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, we think about optionality to ensure that we serve the whole strata of every pension.

Speaker 1

Okay, great. Thank you very much. I think on behalf of this.

Speaker 6

On behalf of this capacity, Florent. As you know very well, we are shooting and we've committed this to triple capacity in 2024 and we've done that. So you were talking about 3rd line. Let me be right here. We have already started to release and distribute B40's disease from the third line as we speak already.

Speaker 6

So this is already installed and that's why I'm very confident that there is no supply challenges that I can trust in terms of constraint for 25 and beyond. In addition, I think you were going back to the growth in 2025, a bit too early to give you some further color on this. As you know very well when it comes to immunization schedule, first there needs to be recommendation set up by the new countries in which we're going to launch and then we'll be able to see more clearly the overall landscape we are for 2025. Where I do see growth coming down the road is North America increased, I would say, penetration of monoclonal antibodies, but also an increase of in Europe and in the international zones with more countries we're going to launch into.

Speaker 1

Thank you, Thomas. Well, thanks for that. The last question, our strong business momentum continued in the Q3 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.

Speaker 1

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.

Powered by Quartr
Earnings Conference Call
Sanofi Q3 2024
00:00 / 00:00