Sanofi

Hello everyone, this is Thomas Kudsk Larsen from the Zenofi IR team. Welcome to the second quarter 2026 conference call for investors and analysts. Fires can be found on zenofi.com. Please turn to slide number three. Here are the forward-looking statements. We would 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 actual results to differ materially. We encourage you to read the disclaimer in the presentation. We also refer you to our Form 20F on file with the US SEC and our French Universal Registration Document. We're going to make comments on our performance using constant exchange rates and other non-IFRS measures. Numbers used are in millions of euros and for the second quarter, unless we state it otherwise. Please turn to slide number four. Here is the agenda for today. We are welcoming Berlin for the first quarterly conference call since joining Sanofi. Berlin will cover our business and its first reflections as a new CEO. You'll also hear from our CFO, François, and our head of research, Mike, on the pipeline. We've expanded to one hour and 15 minutes to allow for the new CEO update and plenty of Q&A. For the Q&A, we also have the support of Manuela, Olivier and Thomas to cover our global business, as well as Roy, our general counsel. You can participate in two ways, either raise your hand in Zoom or submit your question using the Q&A feature. And with this, I now hand over to Belen.

Thank you, Thomas. Welcome, everybody, also from my side. As you can imagine, I'm excited to return to Sanofi, ready to drive the necessary improvement and lead the organization in its next phase of growth. I'm also looking forward to reconnecting with all of you on these calls and through our wider investor relations engagement with transparency and trust. Over the past 12 weeks, I have listened, I have learned, and I have completed the critical phase of my diagnosis. We have already started translating those conclusions into decisions and importantly on near-term priorities. Our teams continue to deliver quarter over quarter as seen by the results. At the same time, I have to fully recognize the challenges confronting us and the need to build strategy that delivers on meet and long-term growth. And I can assure you that this is going to be our focus and we will do it with the right sense of urgency. At the end of the presentation, I will further share my reflections since rejoining Sanofi. And now I will focus on our Q2 headlines. Number one, we delivered strong performance with a double digit sales increase. supported by disciplined cost management leading to double digit EPS growth. Based on our strong performance in H1 and as we plan further sales and EPS growth in H2, albeit with a lower level of growth, we are upgrading our guidance for full year 2026 and François will provide additional detail around this Transitioning to slide number six to go through our quarterly results. In Q2, we continued to deliver very strong growth with a double-digit sales increase, and this is driven by both pharma launches and the continued strength of 2%. Sales from our pharma launches were up by nearly 50%, led by IVA Kit, Altuvio and Sarclisa. Established medicines were stable in the portal. 2% continued its very strong growth, up 37% in Q2, and that was driven largely by volume, that means more patients receiving it. Vaccines declined slightly, mainly impacted by a high comparable from last year's influenza sales. and that was offset by solid Befortus and Eplisa B performance. Overall, we saw good momentum across our portfolio and we are confident in our growth trajectory. Turning to recent launches on slide number seven. Our launch portfolio is a key growth driver. These medicines represent already 13% of our sales and grew over 60% in Q2. Let me walk you through the key contributors. Altuveo continued its strong momentum in hemophilia A and remains the top choice for patient switches in the US. Ivacate continues to expand in systemic mastocytosis driven by continued growth in the number of patients treated and duration of treatment. Sarclisa is performing well in multiple myeloma and we are pleased with the recent subcutaneous regulatory approval that is providing greater convenience for patients. We saw a significant contribution from the EPLISA-B vaccine, one of our latest additions, and the recently launched rare disease medicines, Whey Reels and Cufitlia, are starting to show momentum. What is particularly encouraging is the breadth of this performance, coming from multiple disease areas and the continued growth of both early and new launches. Looking ahead, we have additional launches for these medicines and vaccines in new geographies, and thus we expect this portfolio to continue driving meaningful growth. Turning to immunology on slide number 8. Dupixen has more than 1.5 million patients currently under treatment globally and sales exceeded 5 billion euros in the quarter for the first time. Growth was driven by robust demand across indications and geographies. The U.S. also benefited from a favorable adjustment of gross-to-net deductions in the quarter that François will also detail. As shared previously, we anticipate the growth rate to moderate in the second half of the year as newly launched indications annualize and comparables become tougher. In the U.S., Dupixent remains the number one prescribed biologic across important prescriber groups. With the recent US approval in chronic spontaneous urticaria for children, we continue to expand the depth of indications. Therefore, we have upgraded our 2030 ambition for Dupixent to around 25 billion euro sales, a reflection of the continued strong momentum. Turning to rare diseases on slide number nine, This is an area where I see potential for greater opportunity in the future. Rare diseases sit at the heart of the Sanofi's priorities. Sales in rare reach nearly 1.9 billion euros, up by 24%, and this is driven by IVA kit and Altuvio. Most medicines across the franchise grew in volume. meaning that more patients are being treated for their rare disease conditions. We recognize that some conditions are more prevalent in specific communities and this is why we have tailored our portfolio for China and recently launched two innovative medicines there. Mike Corso, a cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy, and Robert D. C. Dinit, the first ROC-JAC dual-acting inhibitor for myelofibrosis. We will continue to partner with the rare disease communities, communities that we serve, and continue to bring transformative medicines to patients worldwide. Moving to vaccines, on slide number 10, on vaccines, sales reached 1.15 billion euros in the second quarter, 5% lower than last year. And this reflects the high 2025 comparison base in influenza. Influenza vaccine sales declined as anticipated due to the 2025 one-offs and a lower southern hemisphere season. But this was offset by the solid growth of our launches. First, the Fortu sales grew by 54% to 108 million euros, driven by a late US season and continued geographic expansion. Second, Eplisap B grew by 43% on a pro forma basis to 113 million euros, offsetting the expected impact of birth cohort dynamics of the pediatric franchise. Overall, the performance of the Fortus and Eplizab B shows the resilience of our vaccines franchise. Moving to slide number 11, let me speak a bit about our Sanofi Global Health Unit. As you know, around the world, millions of people still lack access to the medicines they need the most. and Sanofi's Global Health Unit is changing that. Through IMPACT, our non-for-profit brand of WHO essential medicines, our medicines are now available in 30 underserved countries. This is a major milestone on our journey to reach 2 million patients suffering from non-communicable diseases by 2030. But access to medicines is only part of the story because the unit is also building stronger healthcare systems across 40 countries with the highest unmet medical needs. Through strategic partnership, we have reached 6.6 million beneficiaries, 6.5 million people have been screened, 1.1 diagnosed, and nearly half a million linked to care. and we have trained over 40,000 healthcare professionals and supported more than 1,000 pharmacies and clinics. Stronger systems, sustained care, this is our commitment. I will now hand over to François, our CFO, for more details on our financials.

Thank you, Belen, and hello everyone. Starting with slide 13, which is illustrating our strong growth, Q2 net sales grew 17.8% to 11.6 billion euros. This growth was primarily volume driven and included as well a couple of hundred millions of positive adjustments in growth to net. Dupixent saw strong and continued patient adoptions and our launches continued to experience solid momentum. Restating for Dynavax and Blueprint sales last year, sales growth would have been around 15%. Our growth margin increased by 3.7 percentage points. This improvement benefited from the reversal of inventory provisions following Sarklissa's sub-Q regulatory approval. Excluding this item, the increase of our underlying gross margin was around 1.7 percentage point, driven by favorable product mix and efficiency. Operating expenses increased by 13.1%, primarily driven by the Blueprint and Dynavax acquisitions. Excluding the impact of this acquisition on one-off costs, OPEX grew at a moderate single-digit rate. As a percentage of sales, OPEX declined by 1.5 percentage points, demonstrating the strengths of our cost discipline. BOI increased by 35.8%, with BOI margin expanding by 3.8 percentage points, driven by gross leverage, cost discipline, and some favorable phasing of capital gains, which were roughly 80 million euros higher this quarter compared to last year. Underlying BOI growth was around 20%. Finally, business EPS grew strongly at 33.3%, excluding share buyback and one-off items, the underlying business EPS growth reached 21%, supported by solid operational leverage. Now turning to H1, sales growth was 15.7% and business EPS was 22.7%, partly driven by the impact of acquisition as far as sales growth is concerned, and by positive run-offs for EPS. Underlying sales growth was around 13%. We will face tougher comps in H2 and we anticipate some deceleration of our sales growth. Indeed, we will lap in H2 against a strong sales momentum last year from Dupixent's new indication as well as a consolidation of Evakit which began in July 2025. Looking further down the P&L, in H2, we expect fewer one-off benefits to gross margin. We don't expect any further Regeneron Development Balance reimbursement, and we will have reduced benefits from share buyback. Turning to our 2026 business dynamics on slide 15, we expect vaccine sales growth to be slightly negative in 2026, mainly crystallizing in H2 due to the usual seasonality of this business. For Q3 specifically, we expect a low to mid-teens sales decrease, reflecting a different distribution between Q3 and Q4 of our respiratory vaccine sales compared to last year. We now anticipate for the full year 2026 a tax rate of around 21%, reflecting the non-deductibility of certain impairment losses on intangible assets linked to recent pipeline decisions. Q2 marks the end of the Regeneron Development Balance reimbursement. For the full year 2026, the increase of Amvutra royalties will fully offset this negative BOI impact. Next year, in 27, we will see a negative 200 million euro BOI gap between these two items. Indeed, we expect a final negative BOI impact from the Regeneron reimbursement of about 600 million euros year-on-year from 26 to 27, while Ambutra Realty's income is expected to increase at the same time by about 400 million euros year-on-year as well. We are also introducing on the right side of the slide the AMVU trial URLT projections until 2030 based on VARA consensus. We take note of recent competitor data which supports our confidence in the long-term potential of this medicine. Flight17, we are upgrading our 2026 guidance to reflect a strong business momentum to date. We now expect sales growth of around 10% at constant exchange rates, with business EPS growing slightly faster than sales. Before concluding, I also want to update our 2030 ambition, originally provided in 2023. Before reviewing the details, a quick word on foreign exchange. When we set this ambition three years ago, we used the euro-dollar rate at that time as our constant currency baseline. Today, we are presenting these updated ambitions still at constant exchange rates, but with today's rate, which is less favorable than it was in 2023. With that context in mind, I'm pleased to confirm that we are upgrading our sales ambition for the three items combined by almost 10% on a like-for-like basis at constant exchange rates. We raised our Dupixent sales ambition for 2030, which is now expected to reach about 25 billion euros, driven by growth across all indications. Our ambitions for pharmaceutical launches remains unchanged and should generate about 10 billion euros in sales, reflecting the strength and diversity of our launch portfolio. And finally, our vaccine business is expected to reach about 9 billion euros in sales thanks to our differentiated portfolio and innovation. The 1 billion euro reduction is split equally between a currency impact and market dynamics. These ambitions reflect our strong commercial capabilities. Let me now hand over to Mike to cover the pipeline section.