Good morning, good afternoon and good evening to everyone. Thank you for joining us to review Sanofi's Second Quarter 2023 Results followed by Q&A session. As usual, you can find the slides to this call on the Investors page on our website at sanofi.com. Moving to Slide 3, I would like to remind you that information presented in this call contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially. I refer you to our Form 20-F document on file with the SEC, and also our Document d’Enregistrement Universel for a description of these risk factors. With that, please advance to Slide 4. Our speakers on the call today are Paul Hudson, Chief Executive Officer; Dietmar Berger, Global Head of R&D ad interim; the Global Business Unit Heads, Bill Sibold, Thomas Triomphe, Olivier Charmeil, and Julie van Ongevalle; and Jean-Baptiste de Chatillon, the Chief Financial Officer. [Operator Instructions] And with that, I'd like to turn the call over to Paul.

Well, thank you, Eva, and thanks to everyone for joining our call today. Together with members of the executive team, I'll take you through Sanofi’s business and financial performance in the second quarter of 2023. Starting with our sales performance on Slide 6, we delivered another quarter of growth in Q2 with Specialty Care and Vaccine as the key drivers. In Specialty Care, sales were up double-digit in the quarter, driven mainly by Dupixent which continues its outstanding growth trajectory. Vaccine sales were up by more than 9%, and we shared with you our excitement for this growing business at our Vaccine investor event last month in London. The approval of Beyfortus in the US earlier in July and the ACIP meeting taking place next week give us strong confidence to continue to deliver mid-to-high single-digit sales growth in vaccines as previously guided. Core assets in General Medicines and Consumer Healthcare also continued to grow. Aubagio, our last meaningful LOE in the decade, as well as non-core assets in GenMed declined as anticipated. In summary, based on solid performance and expected healthy underlying momentum in the second half of 2023, we upgrade our financial guidance for the full year. On the next slide, well, let's have a look at the sales performance in the first half as it looks beyond some impacts from quarterly phasing. Combined, our key growth drivers were up more than 15%, which we believe is a great emerging proof point of our successful portfolio transformation towards innovative medicines. Of note, our standalone Consumer Healthcare business grew 6% in the first half, while we continue to streamline the CHC product portfolio and divest smaller non-strategic brands. Now, on the next slide, let me take a moment to discuss how we continue to drive shareholder value for our…

Thank you, Paul. Let's take a closer look at some of the recent pipeline successes with our innovative assets across key therapeutic areas. Starting with neurology on slide 12, let me first focus on multiple sclerosis. MS is a condition that often strikes early in life and creates a high burden on patients, families, and payers. Frexalimab, our second generation investigational anti-CD40 ligand antibody is implicated in the CD40 ligand pathway appearing to be involved in the MS related inflammatory process. The inhibition of the CD40, CD40 ligand axis in the periphery, upstream of T cell interaction with B-cells, dendritic cells and microglia prevents activation of these cells and may block the inflammation that drives MS disease progression. We presented exciting Phase 2 data of Frexalimab in the first CD40 ligand inhibitor randomized controlled study in RMS at a late breaking session of the 2023 CMSC Annual Meeting. The data highlighted that following 12 weeks of therapy, the number of new gadolinium-enhancing T1 lesions in the MRI was reduced by 89% and 79% in the higher and lower dose treatment arms, respectively, compared with placebo, meeting the study's primary endpoint. At week 24, 96% of participants in the higher dose Frexalimab arm were free of new gadolinium-enhancing T1 lesions. Based on these unprecedented results, we plan to advance Frexalimab into pivotal trials in MS in the first half of next year. Turning to immunology. We have recently announced positive Phase 2b data for Amlitelimab in moderate to severe atopic dermatitis. Amlitelimab is a fully human, non-depleting monoclonal antibody that binds to OX40 ligand, a key immune regulator. It has the potential to be a first-in-class treatment for a range of immune mediated diseases and inflammatory disorders including atopic dermatitis and asthma. Amlitelimab acts more upstream than Dupixent and aims to…

Thank you, Dietmar. Now looking at Specialty Care where we delivered yet another strong quarter with solid double-digit growth despite the anticipated impact from generics on Aubagio in the US, which started in the second half of March. Dupixent performance was excellent in the quarter with demand driven growth across all approved indications and geographies. In rare diseases, our Fabry and Pompe franchises reported near double digit growth in the second quarter with Nexviazyme as one of the key contributors. We are very pleased with the launch of the Nexviazyme in the US and ex-US markets where we continue to successfully drive switches to Nexviazyme as the next standard of care in Pompe disease with an established efficacy and safety profile. Now moving to my next slide. Dupixent sales were up 34%, reaching almost EUR2.6 billion in a single quarter. As highlighted on the slide, the brand drove continuous robust growth in both the US and ex-US geographies. Roughly six years after the initial launch of Dupixent in AD in the US, we remain very excited about the outlook for the brand's outstanding commercial success and expect across the EUR10 billion mark this year. Our key 2023 regulatory milestones are on track and provide additional sources of significant future growth. For example, we talked to you about the filing an upcoming PDUFA date for Dupixent and CSU which is a significant opportunity for expansion into a large population of 300,000 patients in the US alone. Outside the US, we continue to roll out -- the rollout of additional approved indications and additional patient populations in key markets such as Japan and China. Moving to Slide 20. Let's take a closer look at the impressive performance of Dupixent over time. The brand continues to grow its leadership as the number one…

Thank you, Bill. In the second quarter, Vaccine sales were up 9%, driven by PPH performance with strong Pentaxim sales in China and the Hexaxim introduction in new public markets in our rest of the world region. PPH also benefited from favorable phasing. As I highlighted before, in the US, Vaxelis continues to expand and gain market share from pentavalent vaccines, and these sales are not booked in the Sanofi top-line. Meningitis, travel and endemic franchise decreased by minus 6% due to the divestment of Japanese encephalitis vaccine last year. Excluding JEV sales, the franchise performance was stable, signaling that travel and endemic vaccinations are back to their pre-pandemic level. Of note, in Q2, we recorded an additional EUR59 million sales linked to the remaining European shipments of our COVID-19 booster VidPrevtyn Beta. It's not worth it. But during the spring booster campaign in the UK, about half of the COVID-19 doses used were Sanofi boosters. Overall, Vaccines debuted delivered a very strong first half performance with plus 12% growth. Moving now to flu on Slide 23. We do expect to achieve in 2023 the same record sales of last year at constant exchange rate, thanks to the recognized quality of our differentiated influenza portfolio. From a phasing perspective, we currently anticipate an H2 flu sales split between Q3 and Q4 of two-thirds to one-third. The expansion in Europe of Efluelda, a high dose influenza vaccine gaining market share versus standard dose vaccines will be a primary driver as well as the conversion from trivalent to quadrivalent vaccines all over the world. In parallel, we continue to observe relatively low vaccination rates due to post-pandemic vaccination fatigue and some price erosion in the standard dose due to ample supply. But overall, the elderly demographics remains very positive. And based on…

Thank you, Thomas. General Medicine sales in the second quarter were EUR3.1 billion. Our core assets grew 2.4%, driven by double-digit growth of Toujeo and Rezurock, partially offset by lower sales of Lovenox due to competition and the absence of COVID-19 related demand compared to the same period last year. Toujeo Q2 sales grew by 15%, driven by solid volume growth, mainly in the rest of the world markets, including China, which we consider to be a key market for this product going forward. Rezurock continues to grow in the US based on an increased number of patients and a larger pool of prescribing specialists. Sales of non-core assets decreased mainly due to launches, which continue to be impacted by unfavorable US channel mix and a related true-up adjustment in the second quarter. In addition, sales in China were lower to VBP implementation in May last year. In summary, we confirm our full year 2023 objective and expect GenMed sales to decline at a low single-digit rate compared to last year. Turning now to Tzield. Payers have responded favorably with more than 200 million lives in the US now covered, and we are encouraged by the number of enrollments into our patient support program. Improved family support and a shorter time between enrollment and infusion are expected to further drive positive outcomes for at-risk individuals and accelerate the uptake of this innovative therapy. At the same time, scientific organization, patient groups and policymakers have started to highlight the need to screen for Type 1 diabetes proactively. Importantly, at this year's American Diabetes Association meeting, the ADA updated its guidelines to now include a recommendation for Tzield as a therapy for delaying the onset of Stage 3 autoimmune Type 1D in Stage 2 patients. With this, I'm handing it over to Julie.

Thank you, Olivier. Sanofi CHC sales in the second quarter were up 0.7%, negatively impacted by the inventory phasing related to the upgrade of our ERP system in the US and Brazil, as I showed last quarter. While the market continues to grow at a dynamic pace, driven by price and mix, digestive wellness and cough and cold categories continued to perform strongly with double-digit growth. And when looking at the first half sales performance, I'm glad to highlight that all categories reported growth, except for pain care, which was down versus the exceptional COVID-related demand last year. Sales of others were down 13.4% in Q2 as we continue to streamline our portfolio and divest smaller non-strategic brands. In the past three years, we have successfully simplified our brand portfolio and have halved our number of brands. And over the last two months alone, we completed one divestment in Europe and signed a second in Japan. Excluding divestments, our organic growth was almost 2% in Q2 and 7.5% in the first half. In parallel, we're regularly assessing growth opportunities to strengthen and scale our portfolio of brands and geographic footprint. As Paul introduced earlier, I'm very happy to present to you our acquisition of Qunol. Once the acquisition closes, Qunol will allow us to participate in the VMS category, one of the biggest and fastest-growing categories in the world's largest market, which is the US. Qunol is focused on healthy aging, one of the most dynamic segments within VMS and is the number one brand in the US of CoQ10 for heart health as the number one brand of Turmeric for joint health. With a strong science-backed product portfolio, Qunol enjoys above category brand loyalty and has delivered double-digit sales growth due to its premium positioning. Qunol will be joining…

Thank you very much, Julia. And well done, both for Qunol and the B Corp certification is really great. On Slide 31, before taking the P&L perspective, let me highlight the underlying sales performance in H1 by separating out some of the special current drivers. We reported sales of EUR19.7 billion in the first half of '22. When taking out sales lost due to product divestments, Aubagio LOE on EuroAPI carve-out, the base becomes just under EUR19 billion. From there, we added almost EUR1.7 billion in H1 this year, a growth rate of 8.9% at constant exchange rate. Dupixent, across its multiple indication is a key contributor, but I'm also encouraged to see that the recent launches in Specialty Care plus Rezurock in GenMed are starting to play a more significant role. Vaccines remain strong on sales were additionally supported by COVID vaccine sales this year. And in totality, we are offsetting the decline in the US glargine business. On Slide 32, when we look at the Q2 group P&L, we see again a slight improvement in gross margin due to favorable Specialty Care product mix, efficiency gains in manufacturing and supply on COVID vaccine contracts. This was partially offset by generic competition for Aubagio on lower net pricing of launches in the US. R&D expenses were up slightly driven by the growing vaccines pipeline. Pharma R&D spending was lower in Q2 due to a high base effect as several mid to late-stage oncology trials were still in progress in the same period last year. BOI grew 6.6% to EUR2.7 billion this quarter, and it included higher capital gains related to portfolio streamlining compared to the same period last year. More importantly, we continue to benefit from the increased share of profit that is paid by Regeneron towards development cost…

We will now open the call to your questions. [Operator Instructions] Please go ahead.

The first question will be with Emily Field from Barclays. Emily?

Hi. Thanks for taking my question. I'll just ask two. On the first one, we've been getting a lot of questions about how a potential competitor entrant in atopic dermatitis could influence Dupixent, particularly from a pricing perspective. I was just wondering if you could provide some thoughts there and sort of your share expectations moving into the back half of the year? And then also just on flu, what impact are you expecting vaccine fatigue to have on volumes for 2023? And then just any other color you can provide there would be great. Thank you.

Well, thank you -- thank you, Emily. Bill, pricing?

Well, look, thanks for the question, first of all, Emily. And we're excited about the quarter that we've had. We're excited about the future, and we're excited about the competition coming actually. I think it helps us grow the market. I think one of the key things that you have to remember that the future growth is partially driven by bio penetration. And when we have more products there, it helps drive that bio penetration. Now the other side of that is that the best profile wins. And we have the best profile. I think anything you look at that's coming in the pipeline is either incomplete or just inadequate to compete with what Dupixent has already shown in well over 500,000 patients already globally. So I think anyone coming in has a tough time competing just against the best profile, as I said in the remarks, the gold standard. However, it is a competitive market. And whenever you have a competitive market over time, there's always some impact on price. But we've taken all the competition, the new indications, everything into consideration, and it's all considered in our strong growth that we expect for the future.

Thanks, Bill, and very well said. There is -- people forget we already have a lot of competition, and they're doing a really great job and maintaining the right price and the right balance. So thanks, Bill. Thomas, over to you. volumes for flu.

As a segue, talking about competitive fields where we have a great product. I think flu is a very good example. Thanks for your question, Emily. It's difficult to quantify what's going to be in volume, the vaccine fatigue impact. But traditionally, you know that we are not communicating specifically a number of flu doses in terms of volumes but rather on flu sales. Why? Because we are differentiating our portfolio and that's the strategy that has been successful for many years. We focus on products that provide protection beyond flu and that's why we are able to really move the market to superior product and to a superior here. That's why in a competitive field, we are doing very well. And of course, we remain totally ready to take any opportunity in the market. We know very well it's a changing market and should the epidemiology during the flu season be strong and we will be ready to move forward.

Thank you. Thank you, Thomas.

Next question is from Richard Vosser from JPMorgan. Richard?

Thanks for taking my question. Just one more on Dupixent just on the quarter. The growth rate in the US fell a bit more in line with the TRx growth. So -- is that -- the mix is now stabilizing in terms of Medicaid and commercial patients? Or is there a little bit more price pressure or a rebate adjustment? Just some idea of what's going on in the quarter. And then secondly, on the CD40 ligand, efficacy clearly looks pretty good. How differentiated is this? Could this be on safety, convenience, just versus some of the high efficacy products that are clearly taking over the market in MS? Thanks very much.

Okay. Thank you, Richard. So maybe Bill, just a short one, just to cover that off.

Yes, sure. Thanks, Richard. So the US, it's 70% commercial, right? And that's been incredibly stable over time. Look, if you're looking at the quarter versus Q1, gross net unchanged and versus last year, there is some additional contracting and rebating built in there but it's all anticipated. And as I said, we've taken [Technical Difficulty] for the future growth that we expect.

Thank you, Bill. And maybe, Dietmar, CD40 Ligand, and how it will be differentiated?

Richard, thank you for the question. I mean, obviously, there are different medicines available right in MS. The data that we've presented at the MS conference at the MS centers conference actually, we feel is unprecedented, right? When we look at the -- when we look at the efficacy, when we look at the reduction in the gadolinium-enhancing lesions, especially the 96% reduction, that really provides a lot of potential benefit for patients. On the positive side as well, when we look at the safety profile that we've also presented at the same conference, it actually looks very, very well tolerable. So we feel we have both on the safety and the efficacy side, a really important new product, a really important new option for patients. It's a new mechanism. You know that patients do develop resistance, do develop progression to the currently available mechanisms and bringing this new mechanism with this profile to patients will be a real benefit. So really looking forward to that.

Thanks, Dietmar. I was about to tell that actually, that patients still progress, even with standard of care. And we know there's always enthusiasm for a different level of efficacy with the right balance on safety and this will be first and best-in-class. So I think it's pretty exciting for us, the data certainly supports that at this point. Next question?

Next question is from Peter Welford from Jefferies. Peter?

Hi. Thanks for taking my questions. I've got two. Firstly, on Beyfortus. I wonder if you could just talk a little bit about ahead of the ACIP meeting, your thoughts on the pricing that you'll disclose to ACIP and also how we should think about for the ACIP what a positive, I guess, recommendation and vote looks like. And I say that just because there was some confusion, I guess, after the meeting for the adult vaccines as to the implications of it. So I wonder if you could just set up [indiscernible] that would be and what a positive outcome looks like from your perspective? And then if I could just go back to the CD40 ligand, just curious, could you talk a little bit about what the Phase 3 plan is going to be in that study in terms of -- does a Phase III trial now in that setting, do you have to look at CD20s as the comparator -- or what sort of comparison arms can you use in a study like that now for ethical grounds? Thank you.

Thank you, Peter. Maybe Beyfortus ACIP right around the corner, Thomas.

Yes, right around the corner. As you know, very well, registered July 17, ACIP next week, August third. We are very excited and confident about the forthcoming recommendation and the voting. Why? I think I want to explain that there has been great work with the ACIP over the past few weeks, and we've been really reassured by the ACIP recognition of the burden of RSV disease for all infants. So a clear recommendation for all infants is critical and will be successful in my view, to ensure equitable access across the population, which is a very important part to look at when it comes to prevention. So during ACIP meetings in the past, key stakeholders have clearly expressed their interest in ensuring that broad and equitable access and therefore, that gives us confidence. Similarly, we expect inclusion into the VFC program because this decision is critical, again, to ensure equitable access for all infants. So moving forward, we are confident about ACIP.

Thomas, right in saying that we're the only preventative RSV on the agenda at ACIP?

We are, absolutely. And the second part of the question, sorry, Peter, was on price. Very similar to what we said in the past, we want to ensure -- and that's very much linked to the ACIP recommendation. So both go together. If there is a broad ACIP recommendation, we want to ensure there is equitable access for this product to everyone. And therefore, it will be a premium innovative vaccine price, well aligned with what was discussed in terms of pricing during the previous ACIP meetings.

Thank you, Thomas. Dietmar, Peter had some ideas on how you should run the Phase 3 for the CD40 ligand. So over to you.

No, thank you for the question, Peter. I mean we're obviously looking at what the right studies are. We will communicate as soon as we have really taken those decisions and have discussed them also with regulatory authorities. Let me just point out that this is an important new mechanism. And looking at the role that CD40 plays, now as we have a molecule that has that right safety and benefit ratio, right, we will really look at what are the right studies across the spectrum of MS, right? So there's definitely broad potential for the medicine. And I also want to highlight that CD40 ligand is implied across a variety of diseases, right? So this is a major opportunity for us, not only in neurology, but more broadly really in inflammatory diseases.

Thank you, Dietmar.

Next question is from Seamus Fernandez from Guggenheim.

Great. Thank you. So just a follow-up on Beyfortus and sort of the growth expectations based on the ACIP recommendation and the opportunity in hospitals. Just hoping to understand the trajectory of growth. I think historically, for pediatric vaccines, we've seen a substantial uptake, perhaps even approaching peak penetration within three to four years. So just trying to get a better understanding of your thoughts on the trajectory of growth there? And then Separately, on amlitelimab, just trying to get a better understanding. You're speaking about a broad mechanism of action, longer-acting potential as well as competitive efficacy results in that patient population in atopic dermatitis. Just trying to get a better understanding of how long a duration you're looking at, and also differentiation from other OX40 targeted agents that you've discussed outside of this, where safety of targeting the ligand was viewed to be a potential advantage Thanks.

Okay. Thank you, Seamus. Thank you for raising the expectations for Thomas on the launch of Beyfortus. So, Thomas, I'm interested in the shape of the curve, too. So maybe you can answer that.

Always appreciative. Thank you, Seamus. The important thing, first. We're really ready to launch. And again, you will know that it's the first time ever there will be a broad preventive measure to avoid RSV and bronchiolitis in newborns. So very exciting, obviously. Now when it comes to the curve of that launch, a bit early to say, Seamus. We're first going to get this ACIP recommendation. Those two votes as per [Technical Difficulty] are obviously very important. If we go for an equitable and broad access, which we count on, I believe that it will take, as always, vaccines a few years to reach excess. It tends to be a steady, progressive ramp-up over a certain number of years. But again, we are talking here altogether about a EUR2.5 billion market, and we believe there is no asset like Beyfortus in this market. So we are confident about our trajectory for blockbuster.

Great. Well said. Deitmar, amlitelimab, some questions about differentiation against between OX40 ligand and maybe an OX40 and then maybe some suggestion about interval?

Yeah, the -- I mean obviously, we have not communicated the full data yet. They will be at a conference later this year. But even if you look at, if you step back and look at the mechanism, when you look at the data that we have communicated up to now, there is clear differentiation, first of all, from how is the molecule designed. It takes the OX40 ligand, right? It doesn't OX40. It's a nondepleting monoclonal antibody, whereas others that are actually depleting and in that sense, then can lead to, for example, autoimmune phenomena, which we have not seen in the studies that we've communicated so far. OX40 ligand, the OX40, OX40 ligand axis, again is broadly implicated in different types of diseases in immunology and in inflammatory disorders, but it actually acts more upstream, right, as I said before. So it really gets to that homeostasis between pro-inflammatory and regulatory T cells. And you get that specifically when you hit the ligand, not so much when you hit OX40 itself, and that really gets to this distinction between do you see our immune phenomenon, do you get the right benefit risk, et cetera, et cetera. What we're also really interested in, and what we were -- what we're looking forward to further discuss then is, by targeting OX40, can you actually also lead to a reset of the immune system somewhat? Do you have an extended effect, which I think is really important with this medicine. and then how often do you have to dose? And I think you're going well beyond with this, well beyond, like, for example, four to eight-weekly application then. So I think that’s -- there's a lot of really positive potential characteristics to this molecule, and we are very much looking forward to share the full data set later during this year.

And maybe later this year, get also to give more specifics on interval, for example, which could be a significant opportunity, we'll find out. I don't want to miss the sort of last bit on -- we have a readout coming on the OX40 ligand TNF in HS. And I think that's also a little bit of something that could be a new standard. Of course, we don't know. But I think we're trying to do something that's not been done before.

Which is part of an antibody platform.

Yeah. Exactly. Exactly. Okay. Thank you.

Next question is from Peter Verdult from Citi. Peter?

Thank you. Pete Verdult, Citi. Two questions. On Tzield, I don't know whether this question is for Paul or Olivier or Bill, physician feedback on the drug is pretty impressive in the current indication. So just can I push you on any further launch metrics, number of patients on treatment, number of sites that you've got open in the US to offer this 14-day infusion treatment. And then Paul, on PROTECT, I mean, the primary endpoint was positive in recently diagnosed patients, but it was only a numerically trend -- numerical trend on time and range and interim use. I'm just trying to work out sort of over and above that EUR2 billion peak sales. Is that proposition still intact without those secondary end points. And then Bill, I apologize, I'm going to come back to Dupixent only because it's probably near term, going to be an area of focus. I mean a lot of people talk about rebating in price, but I'm just more interested in just Dupixent today in the US, what is the split between commercial and Part D? I'm just trying to work out -- we all know that Dupixent is going to be a huge drug based on where penetration is today in the current indications and the label expansion plans you've got -- but what we -- we need to balance that with potential short-term volume pressures in terms of your competitor -- the only thing they can do is do a very aggressive bridge program. So commercial patients, high deductible plans, would that create some sort of short-term volume pressure on the Dupixent franchise. So if you can explore that a little bit in a little detail, that would be great. Thank you.

Okay. So two questions, it became three. So thank you, Peter. So Olivier, any more color you want to add on Tzield launch?

Yeah. Peter, I think you said it right. The interest around Tzield with our customers with the opinion leaders has surpassed our expectation. Some of us are just back from San Diego. And we have been very impressed by the excitement within the Type 1 diabetes community. We are, of course, very happy with the recent update of the ADA guidelines that we were not expecting so early. We know that, of course, we still have a lot of work to do, and we took the product beginning of May, and we are getting structured. We need to work, and we had it in mind from the beginning of course, on the screening programs in order to make sure that they are consistent. There are a lot of initiatives that are emerging, both in the US but also outside of the US. In the past, there was no, of course, a limited interest to screening, but it's clear that since the registration of teplizumab, the interest of screening has increased dramatically and even some countries are going to go in the direction of systematic maybe baby born screening in the upcoming years. We'll need to work, of course, in order to make sure that there is a limited time line between the intent to prescribe and infusion. So we are conscious that it's a slow, of course, very excited and very impressed, of course, by the positive feedback on the -- from KOL. Continuous rollout in terms of education, in terms of understanding the different stages of type 1 diabetes, Stage 2, Stage 3, that is not always fully understand -- understood. So we will provide you more detail during the call in the next quarter. What I can say about PROTECT is that we have a positive trial with a strong result on primary endpoint of preservation of C-peptide. With KOL, firming at ADA that protecting the beta cell mass for as long, of course, is a clinical benefit. So more to come in the upcoming weeks. But for the time being, very impressed by the initial feedback of the Type 1 diabetes community and KOL.

Dietmar might add something maybe about time and range or some of the nuances.

Yeah. Peter, I think this is really important, right, to discuss this because when you step back, we are really blazing new trails with this program. How long have we waited to have a medicine available for patients with Type 1 diabetes, right? And the initial data delaying on -- delay of onset, were already unprecedented. And now having positive data in the setting of early intervention is another really important data set. And very clear data on the primary endpoint, that's important. The study is positive. The secondary end points describe more the clinical benefit. And when you look at time and range, when you look at insulin use, that's really what gets people excited. We've had discussions at the ADA meeting, very, very positive feedback as you have heard yourself, right? So when we look at the totality of data, this is a very convincing package, and we're really looking forward to discussing those data further.

Yeah. Thanks, Dietmar. I think both summed it up very well. We said when we took this asset that we had some work to do in terms of building the infrastructure and helping support patients. So I think that's going to be a journey for us, but a positive one given the scale of the unmet need and the lack of competition through the rest of the decade. I think Olivier said it really well. I think we've all been very pleasantly surprised by the demand and what that can mean. It's very early days, but I think it's really great to see so many centers wanting to get started. Bill, the Dupixent question.

Thanks, Peter. So just specifically, it's 70%, 7-0 percent commercial in the US. And that's -- I'll remind you now that we have five indications in the US, also multiple age ranges. And I think the thing to take into consideration here as you look ahead and just where we are today are kind of two key numbers. Atopic dermatitis Biopen is 12%. Asthma Biopen is 22%, and we have three other indications beyond that and other indications coming. You've heard me say it now for a bunch of years that we are kind of at the beginning. Still in many ways we are at the beginning. We're at the beginning of the new indications, new age groups, new geographies. So I think there's still a lot ahead of Dupixent. We're really excited about it. You've heard me describe it as a rocket ship, it's a rocket ship.

Thank you. Very clear.

Thank you, Bill. I mean I understand, particularly when people have been over-interpreting the immunology marketplace through Q1 and Q2 in other disease areas that there's a heightened level of questioning, but you have to understand we already have competition in both AD and as -- as Bill said, we have three more indications where first and only pretty much. And then we have this low penetration as Bill said, the market opportunity is so vast and frankly, because so many patients are suffering, let's not forget that, we have so much work to do on that, there's such a pull. So we really are still only at the beginning, and I think people have to really understand it that way. And it's exciting, a 33% growth. I think it was Q2 on a medicine of this size. I think -- and for us to be talking in these terms is really a privilege to be involved in it. Okay. So next question.

Next question is from Thibault Boutherin from Morgan Stanley. Thibault?

Yes. Thank you for taking my questions. I just have two, please. The first one on the -- on US insulins and launches. You highlighted the step-down in sales this quarter for US launches due to net price decline. Was there a specific negative cost rate adjustment in the quarter or any other one-off -- negative one-off? Or should we consider that the sales this quarter in the US for launches is a good proxy for what to expect in the future? And then the second question on the COVID-19 one-off revenues. Can you confirm that these revenues are relating to agreements previously made with European countries? Your slide indicates that you will book them -- the revenues in other revenues. What margin should we assume on these revenues? Is it just a usual vaccines gross margin? And so just a quick follow-up on that. Should we expect that these revenues will not persist beyond 2023? Thank you.

Okay. So JB will come to you on COVID-19 one-offs. And Tom, you put your hand up if you want to add something, Olivier, insulin?

Yeah. So Thibault, thank you for your question. Yes, there was some gross to net elements in the Q2. So the Q2 is not a good proxy for the end of the year. you could use as a good proxy, more of first half decline, which is a little bit above 55%. Even if we think that we are going to do better in the second part of the year, we are in a declining market as large industry to 4% and of course, you know that the volumes are holding pretty well. Our market share has been pretty stable on the [indiscernible] market, 33% to 34%, very consistent across the last five or six quarters. But of course, more sales in the channels that IB discounted, 340B and, of course, Medicare coverage gap. So overall, you should expect a much better second part of the year on Lantus in the US.

Thank you, Olivier. It's -- I touched on it in my presentation about the sort of transformation of the portfolio we're on. The team has done exceptionally well with Lantus. But it very much were the Lantus company for a very long time. And as we transition our portfolio and our pipeline Dupixent beyond, it gets -- Tzield is a good example of that. We're becoming a new company in a new portfolio. And I think it shouldn't be lost as we move from one horse to the other, which is pretty much what our job is to do is to make that successful transition. I think the team, Olivier's team did a really outstanding job on that. So JB, COVID?

Yeah. COVID revenues, I confirm that [50 -- EUR 400] (ph) million will be booking other revenues. And as a proxy, you can take the average gross margin of vaccine applied to that as it is normal.

Maybe the only thing I will add is that Thibault no, we don't expect 2024 similar revenues. So we expect it to be real one-off in '23.

Great. Thank you.

Thank you.

Next question is from Graham Parry from BofA. Graham?

Great. Thanks for taking my questions. So first one is just on your guidance for launch products for Beyfortus, ALTUVIIIO, Tzield of EUR400 million in the second half. I think consensus sales for those is around EUR275 million at the moment. So just where are you more optimistic there? Is this -- are you anticipating a faster launch of Beyfortus than the 150-ish that consensus is forecasting at the moment or an acceleration in ALTUVIIIO, for example? And then secondly, on the Tzield PROTECT study, you sort of seem to shied away from saying whether you think you can file or not. So just to be clear, do you intend to take this data to regulators? And is it your expectation at the moment that to file in that indication you may need more data or a new trial looking at insulin use and time in target glucose range? Thank you.

Graham, thank you very much. The difference, I think, between what you're having consensus and what we put out there for the launches. Firstly, to remind you that -- we wanted to give some type of number to give you a sense of how quickly we're transforming the portfolio. I mentioned that a moment or two ago. I think perhaps one of the biggest gaps in -- versus consensus on Beyfortus and I think we can really close some of that with the end market performance.

Especially after its recommendation.

If we get the recommendation next week, I think back to your original question about shape of launch, I think we'd expect to do certainly, close to consensus -- sorry, better than consensus on Beyfortus. I don't know whether -- I mean, Olivier has already touched on Tzield. I don't know whether -- we'll come back to PROTECT in a moment. But Bill, do you want to add anything other than you've already said on ALTUVIIIO, I mean?

No, look, it's early days, but it is a great product, and it really has the potential to redefine what is possible for Hemophilia A patients because it does get their factor level to normal or near normal. So that takes some time for the community to digest, if you will. But out of the gates, I think we're really strong and really excited. This is kind of the factor and there's been a lot of questions about does it start to make gains with other competitors, non-factors, for instance. And as I said, about 10% of the switches are coming from Hemlibra. And it's not a question of frequency. And I think some of our competitors may make that comment or have. It depends if patients want what is possible from a factor level. And ultimately, why don't they deserve the same right to be closer to normal, like a non-Hemophilia A patients. So we think it's going to take some time for the market to get used to having that possibility and reimagine what's possible. So very excited about that launch.

And Dietmar, anything on the filing?

Yes. I mean the -- again, stepping back for a second, right? You have a positive study. You have preservation of beta cell mass, which is really important for this disease. You have secondary endpoints that show a positive trend that really show that there's clinical benefit. We talked about time in range. We talked about insulin use. And keep in mind, this is on top of continuous glucose monitoring. So this is on top of the best available therapy that these patients can have these days, right? They have the continuous glucose monitor on one arm and the insulin pump on the other arm and they're treating themselves continuously, which means showing additional benefit on top of that is really important, right, for patients. And I'm looking forward to discussing these data with regulators to say it very clearly.

I mean we are spending some time looking at the data because I think you've said it very well. These patients were effectively very well managed. So to show the difference was always a high bar, but there are differences. And I think we hope to get to that point where we can do that. I just want to go back just quickly. I mentioned upfront that -- last year, we see very important medicines, but smaller potentials, Xenpozyme, Enjaymo, Cablivi. This year, it’s ALTUVIIIO, Beyfortus and Tzield, much bigger potential. And as we keep getting into the launch sequence here, we'll be getting to the Amlitelimab and big indications like Dupixent COPD. You're seeing the order of magnitude as the pipeline matures, become much more significant, and that's our role, is to deliver that and to show how that cuts off the things that have been in decline for a number of years. And that -- again, that transition is management responsibility. We're really happy about how that's trending so far. Maybe take another question? We have time.

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

Yes. Thanks very much. I have two questions, Paul, please. So just to follow on what you just mentioned, could you discuss the opportunity for accelerating sales growth prospects following the annualization of Aubagio generic impacts in 2024? And second, could you comment on the outcome of your discussions with the FDA regarding a potential early filing of Dupi for COPD? Thanks very much.

Okay. Thank you, David. Thank you for pointing out that Aubagio is our last meaningful LOE of the decade. So anniversarying that is going to be quite important moment for us -- it's been -- it's a great medicine and it's been giving a lot to the company, but it's our last meaningful LOE. Not sure about the suggestions for growth next year on the back of that. JB, do you want to make a comment?

Well, what we -- what we see when -- when you look at what we published at Q1, looking at having drugs, really blockbuster to launch post '26 going to this area of Dupixent. We are really looking at the growth profile by having three to five drugs in EUR2 billion to EUR5 billion potential sales. So it's really when you take this potential for growth. Of course, we are aiming at growth and that's what we want to deliver. Don't forget that our underlying growth right now is quite impressive already and which gives us a big, great opportunity to deliver. Just if you look at H1 2023, when you take just our growth drivers, Dupixent, Specialty Care products and when you [Technical Difficulty] Gen-med on the Vaccine sales, it's 15.3% just in H1 2023. And I was also showing when you take out the divestments on the LOE of Aubagio on EUROAPI carve-out, we are already enjoying a great growth. We want to stimulate that. We want to be a growth company. Yes, and that's what we do every day.

Thank you, JB. It's quite an important point, and we did put it in the deck for that reason that I didn’t come into this Q&A to talk to about our transition, but we want to make quite clear that 15-plus-percent we recognized, that it's taking off things that are coming to the end of their journey. But the reality is that's a big number. Well, I am not suggesting what it is for next year, you can see where our ambition lies with accelerating the underlying to get to something that we would hope to compete with the best in the industry. So that's what we think. Dupi COPD filing, Dietmar, anything you want to add?

David, thank you for the question. I would love to tell you more, but we're still ahead of those discussions. Right? But let me again also just briefly step back here because I think the BOREAS data in COPD are very important for patients, for us, for the community. What we've seen there in efficacy with a with a well-known safety file is just an -- and will just be an entire change, right, in in how these patients are treated. So I think it's very important that we have those discussions with regulatory authorities, the unmet medical need for patients with COPD is very high. So it's the third most important reason for death on a global basis And we're coming back from the ATS meeting, from the American Thoracic Society meeting, right, where we had the discussion of the data where we presented the data with very positive feedback from the community and key opinion leaders. So we are very much looking forward to have those discussions with the regulatory authorities.

Okay. Thank you. And just to keep making it clear, since Q1 update, I think you've touched on this a little bit, we're still ahead of any significant regulatory conversation. So nothing has changed for us on that, so we remain very enthusiastic. I think it's just worth saying. And I think you touched on it, but in Q2, we had the chance to be at ATS and meet a lot of opinion leaders. And this is very exciting. Let's be honest. This is unmet need for advanced therapy. And so, you should you should know that we will bring our best forward in that regulatory interaction. Okay.

Next question is from Gary Steventon from Exane BNP.

Hi there. Thanks for taking the questions. Firstly, just on the guidance. I guess, how should we think about your ability to continue to ramp up investment in R&D and behind new launches over the mid to near-term? Commentary on growth and the contribution from the new launches is pretty encouraging. So I'm just wondering of how close or not you might be to a point where it's more difficult to reinvest that near-term growth given that the extra COVID vaccine revenues seem to have supported the guidance upgrade? And then secondly, just on consumer, actually, and the strategic priorities here, I mean, you've slimmed down the number of brands, improved growth, we've got the divisional P&L, and today's deal helps to strengthen that US presence. So other than making progress on the OTC switches, and I think an update there would also be very much appreciated? What do you see really as the next steps for consumer on that roadmap? And then just quickly, you mentioned the new deal being a top five product, so any further quantification there would also be helpful. Thank you.

Okay, Gary. Thank you. JB, how are you threading the needle.

Well, we've been studying it for a while. And each time we have this challenge to do new arbitrage, to do one in one out, we improve permanently our growth profile in our pipeline. And as you hear me say often, we still have a lot to do in our transformation and the cost base is still presenting a lot of opportunities. Some are longer to deliver. We are doing a deep work with all our M&S manufacturing and supply team to improve some basics. And we know also that we will have some trade-offs within our own portfolio because that's a story that we are in. To build the growth we need to thread that needle. We reinvest in R&D. That's why we are here.

Yeah. Maybe I also could just add there is, with the management team that we’ve done a lot of great work on reallocating or adding -- giving back to the bottom line. I think we're now working transversely on other sort of structural or systemic opportunities to try and free up more resources. And I think we have a good plan, and I think there's some confidence in the team to be able to do that. Nothing too crazy, but definitely enough to be able to make sure we don't miss a value creation opportunity. Julie, a whole host of things for you to answer ranging from -- don't forget the switches, maybe make a comment about the top five? And what sort of -- what's the next big moment for you and the team?

First of all, Gary, thank you so much for the question because this quarter is a big moment for CHC. And I overall, what I can say is that our ultimate goal is to maximize the value creation of CHC. And what we've been doing in the past [few] (ph) years, we really focus on our existing portfolio, divesting for pruning and divesting a part of it, double downing on the brands that we believe had the most potential And today, we are ready to welcome a new brand that is helping us to really fill one of our strategic gaps and strengthen our geographic footprint. And that's really what we want to continue to do, obviously, is to everything that will drive max value creation for CHC. On Qunol, specifically, again, high quality assets, strong science, in a very special healthy aging segment and one -- it already enjoys high category I mean, brand loyalty. Top five brand means that, again, it has a brand that still has a lot of potential also in the future because it has a premium positioning and also because of it's in its category, but also because of its model and that we believe there's opportunities potentially for other chronic diseases. So a lot of, obviously, looking forward to welcome the brand at closing and to expand it. Then on switches, there is nothing new. Obviously, we continue to work with the FDA on the approval of the switches, and we're advancing on the execution of the -- on their strategy to get the clinical hold, including the generation of the necessary data, and I hope that we'll have more information in -- by the end of the year.

Yeah. So that's part of our next steps. Of course, we would like to unlock the value of those switches and it's still on. We will work on it and apart from that, we have not departed from what we said in December '19, we want to grow consumer health. We want to maximize the value. We want really to give the management teams the maximum opportunity to grow this value. So that's where we are.

Okay. Thank you. Thank you, Julie, JB.

Last question from Jo Walton from Credit Suisse. Jo?

Jo? Maybe on mute.

Yeah. You need to unmute your line.

Apologies for that. I just have two questions, please. I noticed that Dietmar isn't on the Executive Committee just looking at the -- on your website. I wonder if you could tell us when you're going to be in a position to announce the head -- a new permanent head of R&D? And could I just ask related, another R&D-related question. It's a couple of years now since you bought Title IP for the targeted delivery CAR-T, certain cell types? I wonder -- this area still looks to be facing real challenges. Is it still an area of focus for you? Can you tell us when we may hear next steps on it please?

Okay, Jo. Thank you. As with all internal announcements, we'll communicate them when we communicate them. So thank you for the update there. Dietmar, Tidal, I think the question was?

Yes, Tidal. That is a very interesting program within our oncology research at this point in time. It is the approach to use mRNA-based therapeutics to generate CAR-T cells in vivo basically, give the mRNA and generate the CAR-T cells within the patient, which could be entirely disruptive as you know, Joe, right, for the CAR-T cell space. We are progressing that program, is moving forward. We'll give an update once we can. But let me just tell you that this is part of our broader genomic medicines unit and our genomic medicines initiatives that we have and also synergies that we realized with our mRNA center of excellence. And our first product from this genomic medicines unit is actually coming into the clinic this year. It's not a Tidal program, but it's really showing you that progress that we're making on the genomic medicine side. And so far, the program is actually moving forward very well in the research area, and I'm looking forward to bringing that closer to the clinic.

Okay, thank you. Yeah. So thank you. Maybe just a last couple of comments. I think we said upfront, it's a solid quarter. We've given an upgrade to guidance. We've advanced the pipeline. We are reallocating resources to R&D and growth opportunities. I think this is the work that needs to be done, and I think we're really happy with the progress that we're making. Of course, we expect to see an even better performance in some areas as we get through the rest of the year, but time will tell. But we're -- we're very excited about the progress we are making in the company. So thank you to everybody for dialing in and making time for asking questions, and we look forward to reconnecting at the next available opportunity. And, hopefully, many of you just made a note for December the 7th, New York City. I think that would be a good day, quite. Thank you very much.