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Sanofi
10/24/2025
This meeting is being recorded.
Hello, everyone. This is Thomas Gussleisen from the Zenobia IRT. Welcome to the Q3 2025 Conference Call for Investors and Analysts. As usual, you can find the slides on zenobia.com. Please turn to slide number three. Here we have the usual forward-looking statements. We would like to remind you that information presented in this call contains forward-looking statements that are subject to substantial risk and uncertainty that may cause actual results to differ materially, we encourage you to read the disclaimer in our slide presentation. In addition, we refer you to our Form 20F on file with the US SEC and our French Universal Registration document for description of these risk factors. As usual, we'll be making comments on our performance using constant exchange rates and other non-IFRS measures. Numbers used are usually in millions of euros, and for Q3 2025, unless we state otherwise. Please turn to slide number four. First, we have the presentation, and then we take your questions. As usual, we aim at keeping it all to one hour, including questions. For Q&A, we have Olivier, Brian, and Thomas to cover our global businesses, as well as Roy, our general counsel, and Brendan, head of manufacturing and supply. And for the Q&A, you have two options in two. Raise your hand, submit your question using the Q&A function. With this, I hand you over to Paul and my guest, I'm sorry.
Thomas. Thank you, everyone, for joining us today. Our growth momentum continued in Q3 with €12.4 billion in sales, up 7% over last year's high base of comparison. Sales growth was primarily driven by our new launches and the performance of DuPixent, which reached €4 billion in quarterly sales for the first time. After the third quarter performance, we're confident in the business outlook for the remainder of the year. and reiterate our full year 2025 sales guidance. This positive outlook includes our expectations for the business in the U.S., our largest market by sales. We continue to work with the administration and policymakers in the U.S. and around the world on policies that improve access to treatments, lower prices for patients, and improve health systems and protect science. Our recent announcement on the expansion of our patient affordability program Offering improved access to all our insulins is a great example of this work, which I'll discuss in a little more detail later in the presentation. Now, let me highlight the contribution of our new launches, which have been a significant driver of this quarter's strong performance. Our launches delivered 1.8 billion euros this quarter, through more than 40%, and now represent 15% of our total sales. To put this in perspective, our launches represent almost half of Dupixent's sales this quarter. demonstrating their significant contribution to our growth. We've strengthened our commercial portfolio with three new additions. Avakit, our medicine for both advanced and indolent systemic mastocytosis. The first, Sanobi cells of Nivaxavit, offering an important protein-based and non-mRNA alternative for COVID-19 vaccination. And Wayrills, our new BTK inhibitor designed as a multi-immune modulator. This innovative medicine provides a new option for patients with immune thrombocytopenia that extends beyond their platelet count needs to addressing quality-of-life burdens. We're seeing good attack across our portfolio of new medicines and vaccines. Bay Fortis, which achieved blockbuster status last year in its first full year of sales, continues its expansion into new geographies. Altuvio is on track to reach blockbuster status this year, and Abacate, to become our next blockbuster in 2026. Tupixent has reached a new milestone this quarter, exceeding €4 billion in quarterly sales for the first time. More than eight years after its initial launch in atopic dermatitis, we saw an increase of over 30% in the number of patients during the last 12 months. In the US, we've surpassed the €3 billion quarterly sales mark, maintaining leadership in both new and total prescriptions across established syndications, Our launches in the recently approved indications, COPD, CSU and BP, are progressing as planned. Outside the US, sales grew 21%, exceeding a billion euros in the course. We continue our efforts to make Dupixent available to more patients, helped by the positive CHMP recommendation for CSU in the EU and regulatory submission for CSU in children in the US and EU. Turning to our vaccine business, Q3 sales were 3.4 billion euros. This performance compares to a high base in the previous year and reflects the competitive price pressure as well as the lower flu immunization rate in the U.S. A new highlight among our respiratory vaccines is the early start of Novavaxibid, the only non-mRNA COVID-19 vaccine available in the U.S. and from our collaboration with Novavax. The shipments of Novavaxibid were delivered in the U.S. in September. In RSV, Bay Fortis continues its impressive expansion of 20% this quarter, and now available in 40 countries. As you may have seen in our press release this morning, we decided to discontinue our RSV toddler program. While the safety profile was acceptable, the predetermined criteria for efficacy was not met in the planned futility analysis. The PPH and booster franchise remains an important contributor to our vaccine business, with the performance in Q3 reflecting phasing in the first half of the year. Sanepi has a proud legacy in flu vaccines, and we remain committed on bringing innovation to strengthen our leadership in flu and to provide better protection for patients. Our Flu in a DHD study published in The Lancet last week demonstrated that our high-dose flu vaccines at Fluelda, known as Fluzone high-dose in North America, provided superior protection versus standardized vaccines on the sometimes devastating consequences of flu. Data showed an 8.8% reduction in pneumonia or flu hospitalizations, and an important 32% reduction in laboratory-confirmed flu hospitalizations versus standard-dose vaccines. And we're expanding access to this beneficial protection with positive Phase III data that support a label update extending the age down to 50 years for a flu elder whose own high dose. Looking ahead, we're advancing our flu pandemic preparedness with two programs, while improving vaccination convenience with positive data on flu-COVID combination vaccines. These achievements underscore our commitment to delivering enhanced protection against respiratory viruses to more people worldwide. In addition to our unwavering commitment to innovation in respiratory viruses, we're also steadfast in our commitment to improve patients' access to healthcare. Our global health unit has reached a remarkable milestone, a million patients treated for non-communicable diseases across more than 40 low- and middle-income countries since 2021, putting us on track to reach 2 million patients by 2030. We trained over 27,000 healthcare workers and reached 4 million people through our partnership programs during this same period. And we're not stopping there. In the U.S., we're expanding our Insulins Value Savings Program, to ensure every American has access to our insulin at just $35 per month. This initiative builds on S&OP's long-standing efforts to provide patients access to a reliable and affordable supply of critical medicines. Thank you, and I will now hand over to Francois, our CFO, for more details on the financials.
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