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.