Sanofi

Good morning, good afternoon, and good evening to everyone. Thank you for joining us to review Sanofi's first 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, Nipma Berger, Global Head of RMD at Interim, the Global Business Unit heads Bill Stibble, Thomas Triomphe, Olivier Charmet, and Julie Van Angeval, and Jean-Baptiste de Chatillon, Chief Financial Officer. For the Q&A, 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 for joining our call today. Together with members of the executive team, I'll take you through CEMAPI's business and financial performance in the first quarter of 2023. We had a strong start to the year, reporting first quarter sales of 10.2 billion euros, an increase of 5.5%, and delivering double-digit growth across three out of our four businesses. Our specialty care business continues to grow strongly, driven by Dupixent across all geographies, indications, and demographics. We also saw good business momentum from launches in the rare disease franchises, with Nexviazyme increasing its patient share in Pompe. The consistent performance in specialty care is expected to more than offset the decline of Avazio following loss of exclusivity, which we expect to become more meaningful throughout the remainder of the year. Vaccines reported a particularly strong quarter as we keep delivering on our COVID-19 contracts in Europe. In addition, sales of travel and endemic vaccines continue to recover post-pandemic. In general medicines, we continue to execute on our strategy by investing in transplants and other growth assets. while rapidly divesting declining non-core products. Our GenMed core assets continue to grow driven by solid demand. The consumer healthcare business did have a double-digit growth in the quarter across key franchises such as digestive wellness, allergy, and carbon coal. Advancing to slide seven, I'd like to highlight and provide some context around important achievements of the quarter. We have just launched Altubio in the U.S., a best-in-class factor treatment for hemophilia A, with the potential to set a new efficacy standard. The rollout is progressing well and we continue to receive positive feedback from physicians and, importantly, patient communities. Bill will touch more on this in his section. For vituceran, the PACE-3 results were published in The Lancet last month. Scientific evidence is growing that vituceran can become an important addition to the transforming landscape of hemophilia treatments, with as few as six subcutaneous injections per year. For Dupixent, we delivered the first phase three pivotal study in COPD, achieving clinical outcomes never previously seen with a biologic. Remember, in 2019, we outlined our bold approach with our direct to phase three program, shaving years off standard clinical development timelines, And thanks to this, Dupixent is today positioned to be potentially the first approved biologic in a disease marked by a very high unmet need and with huge medical costs that could be offset. COPD today is what atopic dermatitis was six or seven years ago. No advanced therapies, no recent innovation, but with a significant difference. That's that the patient population is already well-identified. We are looking forward to sharing the data with the broader scientific community next month. DeepMath will provide more details in just a moment. Switching gears and moving to another innovation, the acquisition of PreventionBio, which we expect to close today, with T-Zield as its first-in-class therapy to change the course of type 1 diabetes. T-Zield is a great fit to our GenMed business as it provides us with the opportunity to leverage our expertise in diabetes and the existing prescriber network, our strategic focus in immunology, coupled with our deep knowledge in identifying patients with rare diseases, will be critical to the successful launch execution and effective use of patient screening programs. With TSEALD, we are adding another potential blockbuster to our growing GMED core asset portfolio. Coming back to our strategic framework and reminding you of how we continue to execute on our growth strategy as exemplified by the pipeline advances and launches in the first quarter. We are increasingly confident in our ability to fuel our next chapter of growth with innovative compounds and new launches from our pipeline. Specifically in immunology, we are aspiring for industry leadership with an outstanding portfolio of novel molecules. Our immunology assets cover a broad spectrum of inflammatory diseases in areas of high unmet medical need, supporting our ambition to achieve more than 22 billion euros of sales by 2030, generating potential breakthroughs in COPD and acquiring T-Zield with two significant steps towards our goal of launching three to five products with two to five billion euro peak sales potential, each in the second half of the decade. Advancing to slide 9, before I hand over to Dietmar for the R&D update, I want to highlight our upcoming investor events. On May 22nd, we will host an investor call in conjunction with ATF, where the full DUPIX and COPD data will be presented for the first time. We'll combine this occasion with a broader discussion of our growing pipeline in respiratory diseases in vaccine, sorry, in vaccines. Thomas and his leadership team will host an in-person event in London on June the 29th to update you on the progress we're making and our ambition to double vaccine sales by 2030. And finally, we also plan for an R&D day in the second half of this year to provide a comprehensive overview of our early to mid-stage pipeline set to deliver on our ambition to transform the practice of medicine. Imah, over to you.

Thank you, Paul. Now, starting on slide 10, let me give you some additional insights into the recent progress we have made in advancing our innovative pipeline across core therapeutic areas. We are extremely proud of the progress we've made in immunology, with the success of Dupixent and the leadership we have built in type 2 inflammatory diseases. Huge potential remains on slide 11 to transform the practice of medicine for patients suffering from diseases driven by type 2 inflammation. We are determined to expand our immunology portfolio beyond type 2 and to drive innovation by deploying disruptive technologies for the development of first and best in class medicines. On slide 12, let me expand on Paul's earlier comments regarding the truly impressive results from Boreas. a randomized phase three double-blind placebo-controlled trial evaluating the efficacy and safety of dupixent in 939 adults who were current or former smokers aged 40 to 80 years with moderate to severe COPD. All patients in the BORIS trial had evidence of type 2 inflammation as measured by blood eosinophils of greater or equal to 300 cells per microliter. Importantly, they all were on triple standard therapy and still had uncontrolled disease. This means they still experience exacerbations and each exacerbation may leave behind permanent irreversible lung damage. During the 52-week treatment period, patients received Dupixent or placebo every two weeks added to their triple standard therapy. Double maintenance therapy was allowed if inhaled corticosteroids were contraindicated. Primary and all secondary endpoints of the study were met, validating the role type 2 inflammation plays in driving COPD in these patients. It also underscores Dupixen's unique profile. It is the first and only biologic to demonstrate clinically meaningful and statistically significant reduction in exacerbations compared to placebo. Exacerbations were reduced by 30%. a rate of reduction not seen before with biologics in these patients that have exhausted all currently available treatment options. And it is the first and only biologic to show rapid and significant improvement of more than 80 milliliters in lung function compared to placebo. The data also showed significant improvements in quality of life and respiratory symptoms with a safety profile consistent with findings in earlier studies. COPD is an urgent and costly global health concern and a difficult-to-treat disease due to its heterogeneity. We are thrilled to share the full data with the medical community at the American Thoracic Society Conference next month, and we invite you to discuss with us the details of the clinical outcomes achieved with Dupixent in this patient population. Now on slide 13, I'd like to remind you that we are developing not one, but two unique targeted therapies with the potential to build clear leadership in COPD. The mechanisms of action are different, and together they are addressing more than 80% of the COPD population with the highest unmet medical needs. This accounts for approximately 2 million patients in the G7 countries alone. Itopekimab is the second biologic we're developing in COPD in collaboration with our partners at Regeneron. We are studying itopekimab across a spectrum of moderate to severe COPD because of the known effects of IL-33 on both type 2 and non-type 2 inflammation. This is supported by published data demonstrating that IL-33 levels in advanced COPD patients who are former smokers are elevated compared to healthy controls. In our phase 2 study published in The Lancet in 2021, itopecumab reduced COPD exacerbations by more than 40% in former smokers. And importantly, this effect was similar in patients with type 2 and non-type 2 inflammation. We hope that itopecumab may become the best-in-class and first-in-class IL-33 treatment option in COPD. The chart on the right side of the slide summarizes our expected timelines for data readouts and subsequent submissions to regulatory authorities in the U.S. and Europe. Notice the second replicate phase three trial for Dupixent COPD is about to finish recruitment and will read out next year. It's a PECIMAB received FDA fast track designation in January 2023. Results of the pivotal trials ARIFI 1 and 2 are due sometime in 2025, and both trials are reading out concurrently. Turning to slide 14, we are also encouraged by recent results of some earlier stage molecules in our immunology pipeline. We introduced these two highly innovative compounds at our immunology event in March last year. Firstly, SARS-764. a nanobody targeting both IL-13 and TSLP delivered Phase 1b results that will be shared very soon at the upcoming ATS conference as well. The target selection was based on the rationale that blocking IL-13 potentially enhances the more modest impact of anti-TSLP blockade on lung function, while anti-TSLP targeting provides the opportunity to treat a range of asthma subtypes. Targeting IL-13 and TSLP in one molecule promises the potential of enhanced efficacy in a broad range of asthma patients with largely de-risked mechanisms of action. Based on the data we now have in-house, we are moving to phase two in asthma in the coming months. We also have data in-house for SAR-566, our oral TNF alpha inhibitor, potentially addressing the largest therapeutic class in immunology. This inhibitor benefits from its unique molecular design. It binds the TNF trimer and then selectively inhibits TNFR1 signaling, but not TNFR2 signaling. That is important because TNFR1 signaling is pro-inflammatory, while TNFR2 signaling is involved in tissue repair and regulatory T cell expansion. The data set that we have generated so far is pointing to a drug profile that is both safe and efficacious. We plan to present the Phase 1b data in psoriasis at a conference later this year. We are now moving to Phase 2 in psoriasis and look forward to updating you on the potential target profile across a spectrum of inflammatory diseases in the future. Concluding my comments on the progress of the immunology pipeline, the table on slide 15 illustrates how we position our industry-leading portfolio of novel molecules in the highly attractive and growing immunology market. With 12 molecules across key inflammatory disease areas, we are laying the foundation today for our ambition to be the leader in immunology. Switching to neurology on slide 16, let me focus on multiple sclerosis and how we are applying our expertise in understanding MS to develop new treatments. MS is a condition that often strikes early in life, is debilitating and ever-progressing, with a very high burden to patients, families, and payers. Significant unmet need remains, most notably the smoldering neuroinflammation and progressive forms of MS. Starting with tolobrutinib, our brain penetrant and bioactive bruton tyrosine kinase inhibitor. Only tolobrutinib achieves CSF concentration sufficient to modulate B lymphocytes and microglial cells. Data shared today at AAN 2023 showed tolobrutinib to be between 10 to 15 times more potent than other BTKIs currently tested in MS. These data also show that holibrutinib inhibits BTK at least 60 times faster. The combination of sub-nanomolar potency, fast reaction rate, and CNS exposure that exceeds the IC50 suggests a unique ability to engage CNS-resident microglia and lymphocytes, the cells that are thought to drive disability accumulation in MS. Our Phase II clinical data, as well as available Phase II data of competitors, have shown clear signs of efficacy. Recent evidence suggests that the rare liver injury cases observed are likely a class effect, which appears not to be linked to potency. We have currently the broadest pivotal program in place to develop BTKI in MS, with three or four studies recruited, and we expect first results in our MS either later this year or early next year. More importantly, Tolibrutinib is the only BTK inhibitor that is currently tested in secondary progressive MS. The pivotal study is fully recruited, while recruitment in the PPMS study continues, mostly in major European countries. Considering the advanced recruitment status of our pivotal studies, we are currently not largely impacted by the ongoing partial hold in the U.S. We're working on a risk mitigation strategy to allow for safe initiation of the drug, which we expect will be ultimately informed by the efficacy data and the overall risk-benefit profile. Beyond BTK, the CD40 ligand pathway also plays a significant role in the regulation of both humoral and cell-mediated immunity and appears to be involved in the MS-related inflammatory process. Inhibition of CD40, CD40 ligand in the periphery upstream of T cell interactions with B cells, dendritic cells, and microglia prevents activation of these cells and may block the inflammation that drives MS progression. Brexalimab is a second-generation antibody against CD40 ligand and, importantly, does not deplete B or T cells. We are excited to present our Phase II data of the randomized controlled study in RMS, at an upcoming medical congress. Lastly, SAR820 is a first-in-class brain penetrant RIPK1 inhibitor. RIPK1 is a newly described pathway and different from apoptosis and necrosis. It is activated in several neurodegenerative and neuroinflammatory conditions, including ALS, Alzheimer, and MS. SAR820 has demonstrated robust target engagement and CNS penetration at doses that were generally well tolerated in healthy volunteers, and is currently in phase two development in ALS. A phase two study in patients with RMS has just started. Moving on to oncology, I'm delighted to see that the work we initiated in research in 2019 is now starting to be presented at important conferences such as AACR. Today, I want to highlight the NTC Chem 5 Topo 1 antibody drug conjugate. You may remember that 2-sumitamab-reftansin, the anti-CCAM5-DM4, is currently studied in non-small cell lung cancer and other cancers where antituvalin agents have been proven to work. In colorectal cancer, the rate of CCAM5 expression is among the highest, around 90%, and the compound delivers a cytotoxic topoisomerase 1 inhibitor payload to the targeted cells. The data recently generated in mouse xenograft models were just presented at AACR, showing a response rate of more than 50%. We're looking forward to moving this asset into the clinic later this year. And with this, I will hand the call over to Bill.