Sanofi

Good morning, good afternoon, and good evening to everyone. Thank you for joining us to review Sanofi's second quarter 2023 results, followed by a 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 three, 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 20F 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 four. Our speakers on the call today are Paul Hudson, Chief Executive Officer, Dietmar Berger, Global Head of R&D at Interim, the Global Business Unit Heads, Bill Sibbold, Thomas Triomphe, Olivier Charmet, and Julie Van Angeval, and Jean-Baptiste de Chatillon, the Chief Financial Officer. For the Q&A later, you have two options to participate. Option one, click the raise hand icon at the bottom of your screen, or option two, submit your question by clicking the Q&A icon at the bottom of the screen. And with that, I'd like to turn the call over to Paul.

Well, thank you, Eva, and thanks 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 six, 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 Bayfordus 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. Obagio, our last meaningful LOE in the decade, as well as non-core assets in GEMED declined as anticipated. In summary, based on our 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 my next slide, let me take a moment to discuss how we continue to drive shareholder value for our CHC business. Since we embarked on our play to win strategy, it has always been our objective to maximize the value of CHC by bringing it back to growth. Julie and the team have successfully executed on their strategic priorities over the last two years. And as a result, the business has returned to growth in line with the market and delivering 8% organic growth annually. At this point, sustaining growth is critical to further drive the value of this attractive business and to further accelerate the strategic execution. In the US, the world's largest OTC and VMS market, Sanofi CHC has a historically lower revenue base compared to other leading players. The targeted acquisition of QNOL that we announced this morning is addressing the strategic gap in one of the fastest growing VMS categories and has the potential to unlock the additional value. Julie will tell you more about the acquisition in just a few moments. On capital allocation priorities, they remain unchanged, focused on investments into science and innovation, specifically across specialty care and vaccines. Continuing with our biopharma business on slide nine, we are laser focused on the three key launches this year, with each of them representing significant blockbuster potential, addressing high unmet needs in large markets. As a reminder, you'll recall that last year we launched three highly innovative products in specialty care, which we believe we have a potential of up to €1 billion of peak sales combined. Those three products, Zempozyme and J-Mo and Cablivy, were above €250 million in sales in aggregate the first year of their launch. This year, we're launching another three innovative products, each of them with significant blockbuster potential. We believe Altuvio, Bayfordus and T-Zield together can add up to at least 5 billion euros in peak sales. The sales of these important products will build over time, and we are very encouraged by the early launch indicators. Before I let Deepmar dive deeper into the science behind our recent positive R&D readouts, I would like to take a moment and highlight the extraordinary cadence of positive pipeline catalysts, which we've shared with you during the first half of the year. All these pipeline successes have strengthened our confidence in delivering highly innovative medicines, which have the potential to become significant future growth drivers. We look forward to the PDUFA date for Dupixent in CSU in October this year, potentially adding 300,000 biologic eligible patients to the broad label of Dupixent. For T-Zield, well, we made it clear when we acquired Prevention Bio earlier this year that we based the value of the acquisition on the already approved indication and that any additional indications will be further upside. We now have the results of the Phase III PROTECT study in-house. The study met its primary endpoint of preservation of C-peptide and showed encouraging trend in the clinical secondary endpoints. At the American Diabetes Association Congress in June, key opinion leaders confirmed to us that protecting as much of the beta cell mass for as long as possible is a critical clinical benefit for patients. We believe that the totality of the data is compelling and look forward to presenting the full data set at the Medical Congress in the second half of this year. Given the wealth of news and a series of more readouts expected in the coming months, we decided to host an R&D day on December the 7th in New York City to discuss with you these exciting data in much more detail. We want to showcase the progress of our key innovative molecules from our growing pharmaceutical pipeline and further dimensionalize their future commercial potential to help you understand our growth trajectory until the end of the decade.

Dietmar, over to you. 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. Fraxelimab, 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 two data of Rexelimab in the first CD4-delicant 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 increased 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 frexelimab arm were free of new gadolinium-enhancing T1 lesions. Based on these unprecedented results, we plan to advance frexelimab into pivotal trials in MS in the first half of next year. Turning to immunology, we have recently announced positive phase 2b data for amlitalimab in moderate to severe atopic dermatitis. Amlitalimab is a fully human, non-depleting, monoclonal antibody that binds to Oxford 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. Amlitalimab acts more upstream than Dupixent and aims to restore immune homeostasis between pro-inflammatory and regulatory T-cells. In this dose-ranging phase 2b study, treatment with amlitalimab resulted in statistically significant improvements in the average eczema area and severity index, or EZ, score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied. Biomarker results support an effect on both type 2 and non-type 2 pathways. Based on these top-line data, we are particularly excited by MLITELMA's potential for disease modification and infrequent dosing, and we look forward to sharing the full results later this year. We are preparing for Phase 3 studies in atopic dermatitis to begin in the first half of next year. Moving on to my next slide, at our investor call during the ATS meeting in May, we highlighted very positive results from some of our early stage molecules in immunology, including SAR443765 in asthma. SAR765 is a bispecific nanobody that targets both IL-13 and TSLP. With its unique two binding domains, we see this molecule producing a synergistic effect compared to both anti-TSLP and anti-IL-13, as illustrated on the chart on the right. Its target profile has the potential to become the most potent anti-Type II agent with coverage of non-Type II patients as well. Based on this exciting early data, we plan to initiate the Phase IIb program by the second half of the year. Now on slide 15, our regulatory and R&D milestones. As Paul highlighted earlier, we made great progress on delivering our pipeline, including the landmark Boreas results in COPD and the approvals of L2VO and Bayfordus in the US, to name just a few. As we have moved to the second half of 2023, let me also update you on tolobrutinib. As you know, we currently have four phase three studies ongoing, of which three are fully recruited. The Tolibrutinib phase 3 trials are event-driven and powered based on reaching a predefined number of clinical events, defined as six-month confirmed disability worsening or progression. We used historical data to estimate event rates that led to the original projected timelines. As far as the readouts of the trials Gemini 1 and 2 in RMS are concerned, the current actual event rate occurs at a pace that makes us confident that the readouts will occur in the middle of next year. In addition, based likewise on event rate analysis, we now expect the results of the non-relapsing SPMS trial called Hercules earlier than expected, also in the middle of 2024. Importantly, we remain on track for our planned submission timeline of tolibrutinib in 2024, as previously stated, but now with the added opportunity to file both RMS and SPMS together for a more complete data package. Concerning the ongoing partial U.S. clinical hold on the recruitment of new patients for the Perseus study, We are actively working to better understand the tolerabrutinib safety profile and are in communication with the FDA regarding this work. We will update you once we have meaningful new information. And on my last slide, let me finish with a topic that is close to my heart and aims at the inclusion of communities that are historically underrepresented in the development of pharmaceutical innovation. We have embarked on a major journey to design and conduct clinical trials with clearly defined diversity goals, which are representative of disease population demographics. Sanofi's efforts in R&D strive to have these communities represented in our clinical trial programs as much as possible. It is our responsibility as a leading biopharmaceutical company to recognize any difference in the safety and efficacy of our drugs and vaccines that may exist between different populations of people. We will continue to address as many of these access barriers as possible at the earliest stages of study design to advance toward a world where the research we conduct and the data we generate are more representative of the patients we aim to help. And with that, I hand it over to Bill.

Thank you, Dimar. Now, looking at specialty care, where we delivered yet another strong quarter with solid double-digit growth, despite the anticipated impact from generics on Abagio in the U.S., 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 Fabre and Pompey 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 U.S. and ex-U.S. markets, where we continue to successfully drive switches to Nexviazyme as the next standard of care in Pompey disease with an established efficacy and safety profile. Now moving to my next slide, Dupixent sales were up 34%, reaching almost 2.6 billion euros 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 remained very excited about the outlook for the brand's outstanding commercial success and expect to cross the 10 billion Euro 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 and 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 in 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 MBRX across all specialties in the US market. In dermatology, Dupixent is the gold standard in AD across all age groups. Our strong execution of launches has been recognized by Spheric's Global Insights. The report highlights Dupixent and Pregonodularis as the number one recent dermatology launch based on dermatologist familiarity and user base three months after launch. PN has further strengthened our position with dermatologists, reinforcing Dupixent's strong efficacy, including on itch, across multiple inflammatory skin diseases. With the positive experiences in AD down to the age of six months and approval in Pareto nodularis, dermatologists continue to build their strong confidence and familiarity with the brand. In respiratory, Dupixent continues to demonstrate its leadership position in the U.S. asthma market, holding the number one MBRX share in respiratory biologics for the last three quarters among pulmonologists and allergists combined. As you know, advanced therapy penetration is an important marker of both potential and success in these markets. The penetration data on this slide will remind you of the very significant growth potential which remains in AD and asthma for approved therapies, and we are more confident than ever that Dupixent will continue to take the largest share. Now on my next slide, let's switch to Altubio, another exciting launch in specialty care. As Paul mentioned earlier, we are on track to unlock the full potential of this important new therapy in hemophilia A. We are already seeing very encouraging early launch indicators and strong momentum going into Q3. L2VO is capturing an increasing share of switches and has quickly positioned itself as the factor of choice, capturing over 70% of all switches to factor products, with over 250 patients already prescribed L2VO in the U.S., While still early in the launch, switches are mostly coming from HEMA competitor products, including approximately 10% of switches from Hemlibra. We believe this positive trend will continue as more patients gain firsthand experience with the benefits of high sustained factor levels in the normal to near normal range. Commercially, we are making fast progress as well. Over 80% of our priority accounts, who represent the majority of volume share in the Hime market, have already prescribed the product. And from a market access perspective, we have received very favorable feedback from payers. granting coverage aligned with label and no step edits for more than 150 million lives. Importantly, we have implemented a robust patient support program, including reimbursement education and a 30-day free trial program to help accelerate patients starting L2VO while their insurance coverage is verified. With this, I'm handing it over to Thomas.

Thank you, Bill. In the second quarter, vaccine sales were up 9%, driven by PPH performance, with strong Pantaxim sales in China and the exact same 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 Pantavlan 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 GEV cells, 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 59 million euro cells linked to the remaining European shipments of our COVID-19 booster with Preston Beta. It's not worthy that during the spring booster campaign in the UK, about half of the COVID-19 doses used were Sanofi boosters. Overall, the vaccines GBU 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 cell split between Q3 and Q4 of two-thirds to one-third. The expansion in Europe of FLU-ELDA, our 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 market due to ample supply. Overall, the elderly demographics remains very positive, and based on historical data, we generally expect a rebound in flu vaccination rates in the coming years, similar to what was observed after the H1N1 flu pandemic. And on my last slide, I'd really like to underscore that we are advancing our new vaccines candidates and reported rich flow of data from our pipeline in the first half of the year. Following strong Phase 1-2 data, our PCV21 candidate, SP0202, is expected to enter Phase 3 in H1 2024, ambitions to be the first pediatric vaccines with more than 20 serotypes, and has clear blockbuster potential. Similarly, We plan to initiate in H1 2024 the phase 3 of SP0125, our RSV total vaccine candidate, designed to protect children entering their second RSV season. Most importantly, we are fully on track to launch Bay Fortis this fall to protect babies going through their first RSV season and to relieve parents and the healthcare systems from the heavy burden of RSV disease. In the U.S., Bay Fortis was approved on July 17th for the prevention of RSV, lower respiratory tract disease in infants. Building up on this key milestone, an ad hoc ACIP meeting is now set for early next week on August 3rd to discuss nircevim abuse for the coming season, with both a recommendation vote and a vaccines for children program inclusion vote scheduled. Momentum is also very strong in Europe, with medical agencies in France and Spain having published broad infant recommendations for BFortis, and where specific budgets have been set to ensure BFortis coverage for the 2023 RSV season. With this, I hand the call over to Olivier.

Thank you, Thomas. General medicine sales in the second quarter were 3.1 billion euros. Our core assets grew 2.4%, driven by WGD growth of 2G0 and Resuroc, 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. 2G OQ2 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. Resurope continues to grow in the U.S. based on an increased number of patients and a larger pool of prescribing specialists. Sales of non-core assets decreased mainly due to Lantus, which continued 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 TZILS, payers have responded favorably with more than 200 million lives in the U.S. 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 organizations, patient groups, and policy makers 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 T-ZIL 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 CHT seals 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 shared last quarter, while the market continues to grow at a dynamic pace driven by price and mix. Digestive wellness and cough and cold categories continue 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 QNOL. Once the acquisition closes, QNOL 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. QNOL is focused on healthy aging, one of the most dynamic segments within VMS, and is the number one brand in the U.S. of CoQ10 for heart health, as well as the number one brand of turmeric for joint health. With a strong science-backed product portfolio, QNIL enjoys above-category brand loyalty and has a delivered double-digit sales growth due to its premium positioning. QNIL will be joining Sanofi CHE top five brands in sales. Integrating this brand into our existing U.S. commercial infrastructure will enable us to unlock future value within the healthy aging segment. Continuing on our ambition in North America, I'm also extremely happy to announce that Sanofi CHC U.S. and Canada were recently granted the B-Corp certification. As you may know, B-Corp is recognized to be a gold standard among ESG certifications and awarded to companies who have achieved verified high social and environmental standards. This certification will help us to continuously progress and is fully aligned with our ambitious sustainability strategy, which is focused on better self-care and goes hand in hand with healthier communities and a healthier planet. This achievement also enables us to further connect our brands with consumers. As we know that despite high inflation, 66% of Americans and 80% of young Americans aged between 18 and 34 are willing to pay more for sustainable products. We also have seen that products marketed as sustainable grew two times faster than those that were not. We are the first large healthcare company to be B Corp certified in North America, and I hope many others will follow. With this, I'm handing it over to Jean-Baptiste, our CFO.

Thank you very much, Juliane. Well done, both for Kunal and the B Corp. The application 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 19.7 billion euros in the first half of 22. When taking out sales lost due to product divestments or by your LOE on your API carve out, the base becomes just under 19 billion euros. From there, we added almost 1.7 billion in H1 this year, a growth rate of 8.9% at constant exchange rate. The big cent, across its multiple indication, is a key contributor, but I'm also encouraged to see that the recent launches in specialty care plus Resurock and GenMed are starting to play a more significant role. Vaccines remain strong on sales, where additionally supported by COVID vaccine sales this year, and in totality, we're offsetting the decline in the U.S. collagen 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 Obagio on lower net pricing of Lantus in the US. And the 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. BUI grew 6.6%, 2.7 billion euros 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 the development cost of the antibody alliance. In Q3 this year, there will be an inverse effect, as in Q3 2022, we recorded a true-up related to Q2 2022 development balance. On slide 33, let me briefly comment on the CHC P&L. As already signaled in Q1, we expected a softer quarter. This was mainly due to the inventory built in the two largest markets in anticipation of an important software switch linked to ordering and billing. As anticipated, the G&A also continued to grow because of further implementation of the standalone organization. The CRS Q2 was also supported by a meaningful capital gain linked to product divestment. To summarize, we finished the first half-growing EPS again, almost double-digit. This was supported by a strong underlying sales performance when excluding Obagio. The improvement in profitability was further supported by COVID vaccines-related sales and revenues, capital gains phasing, and last year's amended antibody alliance. That more than offset our investments in launchers on the CHE standalone organization. Let's move to the outlook. On slide 36, we are recapping the H2 business outlook. Upixent is expected to continue its strong performance thanks to its many indications and also the still low biologics penetration, especially in atopic dermatitis. We assume a high rate of generic erosion for Obagio, with the product also going yellow in Europe in Q4. Flu cells in the northern hemispheres are expected to be similar to prior year level, and then genmed cell decline is expected to decelerate. We also expect significant contribution from our three innovative launches this year, mainly Altuvio and Befortius, which combined could be over €400 million in cells in H2, based on our plans. On the P&L side, we expect our last COVID vaccine revenues of approximately 400 million euros in H2 to be reported in the other revenues line. Capital gains in the second half will be most likely lower than in H1 and could reach around 200 million euros. This brings me to my final slide, the full year outlook. Based on our resilient business performance in the first half on our COVID-19 revenues, we are raising guidance and expect now EPS to grow mid-single digit at constant exchange rate. We continue to experience headwinds from currency, approximately minus 6.5% to minus 7.5% for full year based on July average exchange rate. Let's now move to Q&A.

We will now open the call to your questions. As a reminder, we would like to ask you to limit your questions to two each. For the Q&A, you have two options to participate. Option one, click the raise hand icon at the bottom of your screen. You will be notified when your line is open to ask a question. At that time, please make sure you unmute your microphone. Or option two, submit your question by clicking the Q&A icon at the bottom of the screen. And your question will be read by our panelists. 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, you know, we've been getting a lot of questions about how a potential competitor entrant in atopic dermatitis could influence dupixin, particularly from a pricing perspective. I was just wondering if you could provide some thoughts there and, you know, sort of your share expectations moving into back half of the year and then and then also just um um on on flu um what impact are you expecting vaccine fatigue to have on volumes for 2023 um and then just any other color you can provide um there would be great thank you well thank you thank you emily uh bill um pricing

Well, look, thanks for the question, first of all, Emily. And, you know, 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 biopenetration. And when we have more products there, it helps drive that biopenetration. 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, you know, 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 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. 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 great products, 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 focused on products that provide protection beyond flu. And that's why we are able to really move the market to a superior product and to a superior care. 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 do very well. It's a changing market. And should the epidemiology during the flu season be strong, we'll be ready to move forward. Thank you. Thank you, Thomas.

Next question is from Richard Vosser from J.P. Morgan.

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 stabilising 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 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.

Yeah, sure. Thanks, Richard. So, you know, the U.S., it's 70% commercial, right? And that's been incredibly stable over time. You know, look, if you're looking at the quarter versus Q1, gross net unchanged, and versus last year, there's some additional contracting and rebating built in there. But, you know, it's all anticipated. And as I said, we've taken 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 center's conference, actually, We feel it's unprecedented, right? 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, you know, 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, Dima. And, you know, I was about to add 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. Thank you.

Next question is from Peter Welford from Jefferies. Peter?

Hi, thanks for taking my questions. I've got two. Firstly, on Bay Fortis, 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 because just because there was there was some confusion, I guess, after the meeting for the adult vaccines as to the implications of it. So if you could just set up your settings as the sort of debates that will be and what a positive outcome looks like from your perspective. Then if I could just go back to the CD40 ligand. Can you talk a little bit about what the phase three plan is going to be in that study in terms of does a phase three trial now in that setting, do you have to look at CD40 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. Thank you, Peter. Maybe bait for this ASIP right around the corner, Tom.

Yes, right around the corner, as you know very well, registered July 17th, ACIP next week, August 3rd. 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 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 with confidence towards ASAP.

Tom, am I right in saying that we're the only preventative for RSV on the agenda at ASAP?

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 SAP 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 three 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've 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 CD4D plays, now as we have a molecule that has that right safety and benefit ratio, we will really look at what are the right studies across the spectrum of MS. So there's definitely broad potential for the medicine. And I also want to highlight that, you know, CD4-delegant 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 Simus Fernandez from Guggenheim.

Oh, great. Thank you. So just to follow up on Bay Fortis 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 amlitalimab, 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 Toma. So Toma, I'm interested in the shape of the curve too. So maybe you could answer that.

Always appreciated. Thank you, Seamus. Now, the important thing first. We are 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 the SAP recommendation. Those two votes, as per the... 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 for vaccines, a few years to reach pixels. It tends to be steady, progressive ramp up over a certain number of years. But again, we're talking here all together about a 2.5 billion market, and we believe there's no asset like B40s in this market. So we're confident about our trajectory for Blockbuster.

Yeah, good. Well said. Timo, I'm going to tell them some questions about differentiation between an OX40 ligand, maybe an OX40, and then maybe some suggestion about interval.

Yeah. 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, you know, how's the molecule designed? It hits the OX40 ligand, right? It doesn't hit OX40. It's a non-depleting monoclonal antibody, whereas others that are actually depleting and in that sense then can lead to, you know, 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 autoimmune phenomena, 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, you know, well beyond like, for example, a four to eight weekly dose. application then. So I think there's a lot of really positive potential characteristics to this molecule and we're looking forward to share the full data set later during this year.

And maybe later this year 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, you know, 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. Exactly. But I think we're trying to do something that's not been done before. Which is part of a nanobody platform. Yeah, exactly. Exactly. Okay. Thank you.

Next question is from Peter Verdult from Citi.

Peter? Thank you. Peter Verdult, Citi. Two questions. On to Zeal. I don't know whether this question is for Paul or Olivier or Bill. position 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 U S to offer this 14 day infusion treatment and then pull on protect. I mean, the, the primary endpoint was positive, um, in recently diagnosed patients, but it was only a numerically trend, numerical trend on time and range and, and interesting use. I'm just trying to work out sort of over and above that 2 billion peak sales. Um, is that proposition still intact without those secondary endpoints? And then Bill apologizes. I'm going to come back to depiction only because it's probably near term going to be an area of focus. I mean, a lot of people talk about rebating and price, but I'm just more interested in just depiction today in the U S what is the split between commercial and part D I'm just trying to work out. We all can, we all know that depiction is going to be a huge drug based on where penetration is today in the, in the current indications and the label expansion plans you've got. But we need to balance that with potential short-term volume pressures in terms of 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 depiction franchise? So we can explore that a little bit in a bit more detail. That'd be great.

Thanks. Two questions that I think became three. So thank you, Peter. So, Olivia, any more colour you want to add on TZ and Launch?

Yeah, Peter, I think you said it right. The interest around T-Zildan 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 screen, but it's clear that since the registration of tebuzimab, the interest of screening has increased dramatically, and even some countries are going to go in the direction of systematic baby-born screening in the upcoming years. We need to work, of course, in order to make sure that there is a limited timeline between the intent to prescribe and infusion. So we are conscious that it's a slow process. Of course, very excited and very impressed, of course, by the positive feedback 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 understood. 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 affirming 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 NKOL.

I think we might want to add something maybe about time and range or some of the other nuances.

Yeah. Peter, I think that this is really important 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 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 endpoints describe more the clinical benefit, and when you look at time in 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.

Thanks, Dietmar. I think... They both summed it up very well. You know, we said when we took this asset that we knew we had some work to do in terms of building the infrastructure and helping support patients. So I think that 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, you know, 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 centres wanting to get started. Bill, the Dupixent question.

Thanks, Peter. So just specifically, it's 70 percent, seven zero percent commercial in the U.S. And, you know, that's, you know, remind you now that we have five indications in the U.S., also multiple age ranges. And I think the thing to take into consideration here is as you look ahead and just where the 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 new indications, new age groups, new geographies. So I think there's still a lot ahead of Dupixen. We're really excited about it. You've heard me describe it as a rocket ship. It's a rocket ship.

Thank you. Thank you. 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 high level of questioning. But you have to understand we already have competition in both AD and S. But as Bill said, we have three more indications. We're first and only, pretty much. And then we have this low penetration. 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, you know, we really are still only at the beginning. And I think people have to really understand it that way. And it's exciting. 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, the next question.

Yes, next question is from Thibaut Boutrin from Morgan Stanley. Thibaut.

Yes, thank you for taking my questions. I just have two, please. The first one on U.S. insulins and Lantus. You highlighted the step down in sales this quarter for U.S. Lantus due to net price decline. Was there a specific negative gross lead adjustment in the quarter or any other one-off, negative one-off? Or should we consider that the sales this quarter in the U.S. for Lantus 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 the usual vaccines gross margin? And also just a quick note 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 officer told me 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 growth 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, you know, our 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, large in 3% to 4%. And, of course, you know that the volume are holding pretty well. Our market share has been pretty stable on the battle plus market, 33% to 34%, very consistent across the last five or six quarters. But, of course, more sales in the channels that I 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. You know, I touched on it in my upfront presentation about the sort of transformation of the portfolio we're on. The team have done exceptionally well with Lantus, but very much we were the Lantus company for a very long time. And, you know, as we transition, you know, our portfolio and our pipeline, do picks and beyond, you know, it gets, TZL is a good example of that. We're becoming a new company, 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, Livia's team, are doing a really outstanding job on that. So, JB, COVID-19.

Yeah, COVID revenues. I confirm that $5,400 million will be booked in 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 really a one-off in 2023.

Great, thank you.

Next question is from Graham Barry from Beaufort.

Great, thanks for the questions. So first one is just on your guidance for launch products for BayFort to sell to VATs yield of 400 million in the second half. I think consensus sales for those is around 275 at the moment. So just where are you more optimistic there? Are you anticipating a a faster launch of Bay Fortis than the 150-ish that ConsenSys is forecasting at the moment or an acceleration in Altuvia, for example. And then secondly, on the TZIL Protect study, you seem to have 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.

Thank you very much. The difference, I think, between what you have in 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 Bay Fortis. And I think we can really close some of that gap. you know, with the in-market performance. Especially after the recommendation. Yeah, if we get the recommendation next week, I think that's the original question about shape of launch. I think we'd expect to do certainly better or closer consensus, sorry, better than consensus on paid forwarders. I don't know whether, I mean, Olivia's already touched on 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 L2BO?

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 patients because it does get their factor level to higher. near normal or near normal. So, you know, that takes some time for the community to digest, if you will. But, you know, out of the gates, I think we're real strong and really excited. This is, you know, kind of the factor. And, you know, 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 non-hemophilia 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 we're very excited about that launch.

And Dietmar, anything on the filing? 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, you know, show a positive trend that really show that there's clinical benefit. We talked about time and 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 their continuous glucose monitor on one arm and their insulin pump on the other arm. And they're treating themselves continuously, which means, you know, showing additional benefit on top of that is really important, right, for patients. And I'm looking forward to discuss this data with regulators to say it very clearly.

And 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, you know, we hope to get to that point where we can do that. You know, I just want to go back and just quickly, you know, I mentioned it up front that last year it was three very important medicines, but smaller potentials, Zambazam and J-Mocablivi. This year it's Altuvio, Bayfordus and T-Zield, much bigger potential. And as we keep getting into the launch sequence here, You know, we'll be getting to the amlitellamabs and big indications like Dupix and COPD. You know, you're seeing the order of magnitude as the pipeline matures become much more significant. And, you know, that's our role is to deliver that and to show how that cuts off the things that have been in declining for a number of years. And that, again, that transition is management's responsibility. And we're really happy about how that's trending so far. Maybe take another question. We have time. Yes.

Next question is from David Reisinger from Learing. David?

Yes, thanks very much. I have two questions, Paul, please. So just to follow on on what you just mentioned, could you discuss the opportunity for accelerating sales growth prospects following the annualization of Obagio 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. Thank you, David. Thank you for pointing out that Obagio is our last meaningful LOE. of the decade, so anniversarying that is going to be quite an important moment for us because it's a great medicine and it's been given 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 see when you look at what we published at Q1, looking at... having drugs really blockbuster to launch post-26, going to the salary of the big size, we are really looking at a growth profile by having three to five drugs and two to five 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 It's quite impressive already, which gives us a great opportunity to deliver. If you look at H1 2023, when you take just our growth drivers, the big sense, specialty care products, and when you... of GenMed on the vaccine cells, it's 15.3% just in H1-2023. And I was also showing when you take out the divestments on the LOE of Obagio, on your API carve-out, we are already enjoying a great growth. We want to stimulate that. We want to be a growth company. Yes, 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 start talking about our portfolio transition, but we wanted to make it quite clear. that 15 plus percent, we recognize that it's taking off things that are coming to the end of their journey. But the reality is that's a big number. And while we're not suggesting what it is for next year, you can see where our ambition lies with accelerating the underlying to get it to something that we would hope to compete with the best in the industry. So that's what we think. Do PCOPD filing, Deepmar, 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 well-known safety profile will just be an entire change in how these patients are treated. 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. It's the third most important reason for death on a global basis. And we are 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, yeah, thank you.

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

Next question is from Gary Stevenson from Exxon 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 near term? Commentary on growth and the contribution from the new launch is pretty encouraging. So I'm just wondering kind 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 EOTC 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, to improve permanently our growth profile and our pipeline. And as you hear me say often, we still have a lot to do in our transformation on the cost basis. It's still presenting a lot of opportunities. Some are are longer to deliver. We are doing 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 the 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 also I could just add that there is a management team that we've done a lot of great work on reallocating or adding, you know, giving back to the bottom line. I think we're now working transversely on other sort of structural 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 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, you know, don't forget the switches, maybe make a comment about the top five. And 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 CHE. And I think overall, what I can say is that our ultimate goal is to maximize the value creation of CHG. And what we've been doing in the past two years, we really focus on our existing portfolio, divesting, pruning and divesting a part of it, double downing on the brands that we believe have 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 CHE. On QNOL specifically, again, high quality assets, strong science in a very special healthy aging segment. And what it really enjoys high category, I mean, brand loyalty category. 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 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 on their strategy to give the clinical hold, including the generation of the necessary data. And I hope that we'll have more information 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. 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 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 Joe Walton from Credit Suisse.

Joe, maybe you're 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 on your website. I wonder if you could tell us when you're going to be in a position to announce a new permanent head of R&D. And could I just ask another R&D-related question? It's a couple of years now since you bought Tidal IP for the targeted delivery, you know, 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. Dima, title, I think the question was?

Yeah, title. 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. It's 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 there that we realize 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 title 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 arena, and I'm looking forward to bring that closer to the clinic.

Okay, thank you. Yeah, so thank you. Maybe just the last couple of comments. I think we said up front, it's a solid quarter. We've given an upgrade to the 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 you know, an even better performance in some areas as we get through the rest of the year, but time will tell. But we're, no, we're very excited about the progress we're making in the company. So thank you to everybody for dialing in, for 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. All right. Thank you very much.