Valneva SE

Good day and thank you for standing by. Boniva presents its first quarter 2026 financial resorts. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again. Please be advised that this conference is being recorded. I would now like to hand the conference over to your speaker today, Joshua Drum, Vice President, Global Investor Relations. Please go ahead.

Hello, and thank you for joining us to discuss Valnevo's financial results for the first quarter to 2026 and corporate update. It's my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the three months ended March 31st, 2026, which were published earlier today, available within the financial reports section on our investor website. I'm joined today by Valneva's CEO, Thomas Lingelbach, and our CFO, Peter Buehler, who will provide an overview and update on our business, as well as our financial results. There will be an analyst Q&A session at the conclusion of the prepared remarks. Before we begin, I'd like to remind listeners that during this presentation, we will be making forward-looking statements, which are subject to certain risks to differ materially from those expressed or implied by these forward-looking statements. You can find additional information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French Market Authority, which are listed on our company website. Please note that today's presentation includes information provided as of today, May 13, 2026, and Belneva undertakes no obligation to revise or update forward-looking statements except as required by applicable securities laws. With that, it's my pleasure to introduce Thomas to begin today's presentation.

Thank you, Josh. Good day, everyone. Yeah, our first quarter was certainly dominated by the LIME Phase III readout. With the strong efficacy observed, the first pre-specified statistic criterion not met, but the second one met, Pfizer is planning for submissions to regulatory authorities. On financials, we reported a top line of approximately 30 million euros. A year-on-year, quarter-to-quarter comparison is, however, with regards to this first quarter, not really meaningful because of various factors, including a different business setup, supply facings, one-off effects on the expense side. All of that will be elaborated by Peter during his respective financial report. Given the level of uncertainty around Lime, Our strong focus is on cash containment and management. We reported a strong cash position, which excludes the proceeds from the recent financing, more than 100 million total cash at the end of the first quarter, and launched a comprehensive program to reduce our operating expenses, which also includes reduction of global workforce by approximately 10 to 15% and aims to result in a significant 25 to 35% reduction in our operating expenses as compared to last year. With that, let me turn to our programs and to our key business activities. I reported already about the statistical myths and the fact that the second pre-specified statistical criteria met the lower bound. Overall, the efficacy, as you can see on the slide, is above 70%, which is really strong. The vaccine was well tolerated. There were no safety concerns identified at the time of analysis. The reason for all of that is we have observed fewer than anticipated Lyme disease cases that were agreed over the study period. Given, however, the clinically meaningful efficacy and the fact that the 95% confidence interval lower bound was above 20 in the second pre-specified analysis, Pfizer is confident in the vaccine's potential and hence, as mentioned earlier, is planning submissions to regulatory authority. Lyme represents a major medical need and hence market opportunity. There is no vaccine currently available to prevent Lyme disease in humans. And we see a continuous rise of the annual burden of disease. We have here in this slide reported the numbers of people who live in high-risk areas of Lyme disease, almost 90 million in North America, more than 200 million in Europe, and an annual disease burden of a reported 500,000 cases in the U.S., more than 100,000 in Europe. Also, we all acknowledge that those reported numbers are probably heavily underreported. Clinically, Lyme comes with different clinical manifestations. Ten to 30% of the individuals develop either catiasis, neuroborreliosis, or arthritis. and some, namely 5% to 10%, the cases continue to have persistent symptoms even following treatment. As such, we see VLA15 or LB6V, using the Pfizer terminology, as a compelling opportunity in a highly underserved market. It is the only Lyme disease vaccine candidate in such a stage of development in nearly 30 years. It's highly differentiated. We built on a proven mode of action, but with a broad coverage addressing all the prevalent serotypes prevalent on both sides of the Atlantic. It is a modern, state-of-the-art recombinant protein-based subunit vaccine. We tested individuals in the study aged five years and above. And as I mentioned, we continue seeing a growing disease burden across high-risk areas. And some of you have recently seen, again, articles in this regard. There is, of course, a strong strategic fit with Pfizer's existing business and franchise. And overall, we really see a prophylactic solution as the solution of choice for this disease. As such, we remain confident. We remain confident in the prospect of this vaccine to ultimately make its way to patients or to people who are in need of it. Turning over to chikungunya, our egg-stick product, you know, is continuing its path through different R&D activities besides, you know, limited commercial sales in travel. The overall market evolution, market development and access in emerging markets and low-medium income countries is, however, quite remarkable and it's progressing quite nicely. We have a very significant pilot vaccination campaign ongoing in Brazil. The vaccine is being given to adults 18 to 59 years of age. And the objective is to reach a 20 to 40% coverage within this target population across various municipalities in Brazil. We have already vaccinated more than 30,000 people to date. And we are aiming for much more than 100,000 overall. There is also additional work ongoing to prepare for post-marketing effectiveness in Brazil and in other jurisdictions. Currently, we are focusing on creating a strong safety database with our study 406, which is well advanced and is nearing completion of the enrollment. We are working on ensuring greater access to this vaccine in endemic countries. We have a project ongoing to expand the network of manufacturing and distribution partners in those countries, and we are making good progress. We reported very recently through our different social media channels that the locally produced chikungunya vaccine by Butantan, called Butantan Chik, achieved licensure in Brazil. This has been a major, major achievement in the endeavor that is supported by CIPI and for which we are grateful on advancing this vaccine and advancing access into countries and for countries who can really benefit from it. A few words on Shigella and our Shigellosis program. It is certainly one of the most advanced, if not the most advanced, tetravalent vaccine candidates against Shigellosis. We are targeting the four most common pathogenic Shigella bacteria. And previously, our partner, Lima Tech, reported positive initial Phase I-II data. We have currently two studies ongoing, one in children in Africa, and the other one is an immunogenicity and pyrodificacy study, so-called controlled human infection model for both. We are expecting the first readouts or the readouts over the summer. And then, as we discussed and reported previously, we will decide on next development steps for this program and for this program addressing a global market that is expected north of half a billion annually. Given the severity of shigellosis, especially the fact that it is the second leading cause of fatal diarrhea in children. And it therefore has been prioritized by WHO and other funding institutions. So overall, a lot going on on our key R&D and business activities. And with that, I would like to hand over to Peter to provide us with the financial report.