Sanofi

Hello, everyone. This is Thomas Grusazen from the Zenobia IRR team. Welcome to the Q1 2025 conference call for investors and analysts. As usual, you can find the slides on zenobia.com. Please turn to slide number three, please. Here we have the usual forward-looking statements. We'd like to remind you that information presented in this call contains forward-looking statements which are subject to substantial risk and uncertainties that may cause active results to deeper material. We encourage you to read the disclaimer in our slide presentation. In addition, we refer to our new Form 20F on file with the U.S. Agency in our Friends Registration Document, a description of these risk factors. As last quarter, financials reported are under the new reporting scope that excludes the appellate consumer health business. As usual, we will be making comments on our performance using constant exchange rates and other non-IFRS measures. Numbers used are millions of euros, and for Q1 2025, one is stated otherwise. Now please turn to slide number four. First, we have a presentation, then we'll take your questions. We have kept the presentation as shown as in the past, and other companies report today, and we aim at keeping the call to maximum one hour. With Q&A, we have Brian, Olivier, Thomas to cover our global businesses, as well as Roy, our general counsel, and Brendan, head of manufacturing, and Tobias. With the Q&A, you have two options in Zoom. Raise your hand or submit your question using the Q&A function. With this, I'll hand you over to Paul.

Well, thank you, Thomas. Nicely done. And hello, everyone on the call. We had a strong start to 2025 with a 9.7% sales growth in the first quarter. Our strategic focus on innovation continues to deliver, driven by pharma launches, D-PIX and Bayfordus in our vaccine portfolio. Let me highlight our performance of new launches on Flight 6. In Q1, our launches generated €1.1 billion in sales, contributing 11% of the total. This performance was driven by an element of Bay Fortis phasing and expansion in Europe and the rest of the world. Altubio benefited from continued patient switches and has the potential to become our next blockbuster this year. Of note, on March 28th, we obtained FDA approval for Cupipia in Haemophilia, one of three potential launches this year. with initial prescriptions already recorded in early Q2. Moving to side seven, Dupixent. Dupixent delivered strong growth of 20% in Q1, driven by broad-based demand, and reached €3.5 billion of sales. In the U.S., sales were €2.5 billion in the quarter, up 18%. Dupixent now also leads total prescription share across all approved indications. As usual in the first quarter, US sales reflected the impact from the annual reset of insurance deductibles, driving higher utilization of co-pay assistance. Outside the US, Dupixent sales exceeded €1 billion for the first time, supported by the contribution from Japan, China, and Germany. Looking at the remainder of the year, we will continue to drive Dupixent's growth across our markets and in all approved indications. As a reminder, biopenetration still remains quite low, We are excited about the U.S. approval for CSU last week and the upcoming regulatory decision in the U.S. for bolusamphigoid. These additional indications continue to expand our leadership across type 2 inflammatory diseases. On slide 8, let me briefly remind you of the high and met need among people with uncontrolled COPD, many of whom have resigned themselves to their condition. Epipsyn is the first biologic medicine approved in this disease. We have already launched CABD in eight countries, including the US, Germany, China, and Japan. Dupixin's value is being recognized by payers in key countries, ensuring access for all patients. To improve adoption, we focus on two main objectives. First, we continue to educate pulmonologists about Dupixin's benefits, the role of type 2 inflammation, and the urgency to treat patients. Second, to drive patient awareness. In April, we just launched our DTC campaign in the US. Moving to slide nine, our vaccine business delivered double-digit growth in Q1. This performance was driven by favorable Bayport phasing and new country launches. In the U.S., we are focused on improving the immunization rate to ensure infants born in late season are also immunized and protected. Turning to flu, our manufacturing is progressing as planned, following the WHO and FDA strain selection. As the world leader in flu vaccines, we continue to focus on improving the vaccination rate increasing awareness of the benefits of our differentiated flu vaccines. On our vaccines pipeline, we continue to push the boundaries of innovation, pioneering the development of a vaccine candidate for the prevention of chlamydia. In March, the US FDA granted fast-track designation and recognition of our commitment to improving public health and addressing high unmet medical needs. On Friday 10th, I'd like to introduce you to our updated sustainability strategy. focused on aligning health outcomes with environmental and social responsibility. Environmental challenges and human health, an estimated 3.6 billion people are living in climate-sensitive areas, with 6 million deaths reported annually from air pollution alone. That makes it clear people's health and environment aren't deeply linked. Our new air strategy focuses our efforts on three strategic imperatives, access to healthcare, environmental impact, and the resilience of healthcare systems. With over 70% of our portfolio and more than 75% of our pipeline involved in climate-related diseases, Synergy has a key role to play. And through AIR, we are furthering Synergy's commitment to global health by working to break the cycle of environmental decline and declining public health. Thank you. I'll now hand over to Francois, our CFO, for more details on the financials.

Thank you, Paul, and hello to everyone. As highlighted by Paul earlier, our net sales increased by 9.7% at constant exchange rates to 9.9 billion euros. This growth was primarily driven by Dupixent, by our new product launches, and by favorable phasing in vaccines. Growth margin improved significantly to 78% at 2.3 percentage points from the previous year, driven primarily by an improved product mix and by efficiencies. Our Q1 effective tax rate was 22.3% linked to a one-off item this quarter. We maintain our full year indication of a broadly stable effective tax rate versus 2024, which means around 20% for this current year. Business EPS was 1.79 euro, up 15.7%, reflecting our strong sales performance, our improved gross margin, and our operating leverage. This Q1 growth confirms our expected strong EPS rebound in 2025. Moving to Opella, we expect to close the transaction in the coming days. Sanofi will receive about €10 billion while retaining a significant stake in Opella to support the company in its journey to independence and to participate in its future value creation. The expected proceeds from this end will be reallocated in accordance with our capital allocation policy presented on the right-hand side of this slide. First, our primary focus is to invest in our business to drive organic growth, which means investing in R&D, sales and marketing, industrial assets, AI, and talent, just to name a few. Second, we continue to explore external growth opportunities through Bolton acquisitions, In March, for example, we agreed to acquire DR0201 from DrainBio. These promising molecules transcend our early pipeline in immunology. Third, we maintained our progressive dividend policy, and 2025 will mark our 30th consecutive year of dividend increase. Fourth, regarding value-enhancing share repurchases, we are executing our €5 billion share buyback program in 2025, with 76% already completed as of yesterday. We have repurchased 37.7 million shares at an average price of €101.5, all for the purpose of conservation. This underscores our commitment to delivering long-term shareholder value and partially mitigating the dilution from the Opela transaction. Looking ahead to the balance of 2025, I would like to remind you of some anticipated key business dynamics which may be helpful for modeling purposes. For Q2, please note that Lantus USA started to increase materially in Q2 2024 due to the unavailability of a competitor's product, representing a higher base of comparison for the next few quarters. Despite this higher baseline, we expect stable sales for launches in 2025 as we continue to capitalize on favorable market dynamics and competitive opportunities. In R&D, we remind you that we received, in Q2 2024, a wonderful payment from Sobi of about €200 million for the development of Altuvert at the time of approval in Europe. For the full year 2025, foreign exchange impact is moving against us, and it is now estimated to be around minus 1.5% on sales and around minus 2% on EPS. All other business dynamics remain unchanged compared to what we communicated at the beginning of the year. I now hand over to Oumad to provide an update on the progress of our innovative pipeline. Thank you, François.