Thomas Lingelbach
Analyst · Jefferies
Thank you. Hello, and thank you for joining us today. As we reflect on 2025, I'm proud to say that Valneva once again demonstrated resilience, discipline and an unwavering sense of purpose. In a year marked by geopolitical uncertainty, rising vaccine hesitancy and further consolidation in the biotech sector, we stayed focused, remain agile and continue strengthening our position as an innovative and recognized vaccine company. Our financial performance was solid. Total revenues exceeded EUR 170 million, slightly above 2024 levels, including almost EUR 160 million in product sales. These results reflect not only foreign exchange headwinds and the planned reduction in third product sales, but also growth in our proprietary travel vaccine portfolio. We closed the year with a cash position of nearly EUR 110 million and further enhanced our financial flexibility through a successful debt refinancing. We also achieved more than a 20% reduction in operating cash burn, driven by our continues disciplined cash management. Most importantly so, together with our partner, Pfizer, we further advanced our Lyme disease vaccine candidate. This program represents an important opportunity for Valneva and for the millions of people at risk of Lyme disease, and we are looking forward and crossing fingers for the pivotal Phase III results. Turning to how we see Valneva's strategic evolution. Our strategy is geared towards becoming the leading vaccine biotech company based on three important pillars: On the one hand side, we expect to further grow our commercial business and to optimize the cash generation through the commercial business. We will certainly continue maximizing R&D upside for our investors, leveraging our proven track record in R&D progression in our ability to bring products from bench to global licensure, and we will do so by leveraging our integrated business model. On the one hand side, commercial, manufacturing and development, which can be beneficial to advance and augment programs in our R&D pipeline. Let's look a little bit at the different programs in our portfolio. And I'm now starting, of course, with the leading Lyme disease vaccine candidate in the world, VLA15. So if you look at Page 8 of the presentation, this is a summary that shows you the growing and emerging problem that Lyme disease represents. There is currently no vaccine available to prevent Lyme disease, and also treatments are somewhat suboptimal. We are seeing a growing annual burden of the disease with reported almost 500,000 cases in the United States annually. And in Europe, it's probably going to be the same order of magnitude also the reported and the officially reported cases are a bit more than 130,000 annually. The important thing about Lyme disease is its severe clinical manifestations. 10% to 30% of cases develop many different clinical manifestations, which can be categorized in three buckets: carditis, neuroborreliosis and arthritis. And most importantly, 5% to 10% of the cases continue to have persistent symptoms following treatment with antibiotics. We are evaluating VLA15 right now in a placebo-controlled field efficacy study called VALOR. This study includes approximately 10,000 individuals. It's a study that is randomized 1:1 placebo against vaccine, 2:1 U.S. versus European sites or per site North American versus European sites. And the primary endpoint is disease prevention after 3 plus 1 doses, namely in season 2, which we have also tested as part of this study. We completed last year all vaccinations and we are now in the process of testing and evaluating the data. And as I said earlier, we hope that we're going to get, of course, good data, and we have guided for data in the first half of this year. So in summary, VLA15 is a compelling opportunity in a really underserved market. It will be definitely the first vaccine if approved to address this disease. It is a highly differentiated vaccine state-of-the-art when it comes to the vaccine composition addressing the main and predominant serotypes of Lyme borreliosis in the Northern Hemisphere. It is -- will be representing a compelling target population and a use case with a broad addressable population. We have tested in the study people above 5 years of age. And we see really an opportunity here to address a very, very large target population. Of course, there is also a strategic fit within Pfizer's vaccine franchise, and we are very pleased to have a strong partner with Pfizer for the future, commercial opportunities ahead for this vaccine. And of course, there is a clearly attractive commercial dynamic. Prophylactics are always cheaper than therapy and a potential inclusion in some of the routine immunization schedules for high-risk areas would really be a perfect opportunity. So with that, we see a unique and compelling opportunity that, of course, could be transformational for Valneva. So again, we are looking forward to the data, fingers crossed. So if we turn to IXCHIQ, you know that we are still investing in the further development of what we call VLA1553 or the marketed trade name, IXCHIQ. Currently, we have three major R&D activities on IXCHIQ. We are very glad that we have been able to initiate a pilot vaccination campaign which is ongoing in Brazil. We launched it in February with our partner Instituto Butantan, selected municipalities in Brazil. We cover the age range currently licensed by Anvisa in Brazil, namely 18 to 59 years of age. And the objective is really to achieve a 20% to 40% coverage within the target population. And right now, the vaccination uptake is quite compelling. We are further investing in post-marketing effectiveness studies to confirm the effectiveness and to optimize the description of the safety profile. And this is a pragmatic randomized controlled effectiveness and safety study in adults and adolescents in endemic countries. And of course, we continue to work on ensuring greater access to address the unmet medical need in endemic countries. And we are in the process of expanding our network of manufacturing and distribution partners in low and middle income countries. So overall, I would say, IXCHIQ did not have a great start in the travel segment, but we have been able to refine our labels and discussions. And we are now focusing mainly on post-marketing effectiveness and global market access. Turning to shigellosis. So our program called S4V2 is a vaccine that targets shigellosis. It's a tetravalent Shigella vaccine candidate that we in-licensed from LimmaTech, and it's currently the clinically most advanced Shigella vaccine candidate. And therefore, we see here an opportunity to develop a first-in-class vaccine in a really life-threatening disease. When you look at the market opportunity and more importantly, the clinical and medical need, you need to recognize that it is currently representing the second leading cause of fatal diarrhea, especially in children. And therefore, it has been identified as a priority vaccine by WHO. Valneva has worldwide commercial rights upon potential approval. And we see here really two major markets. On the one hand side, travel. This is certainly a vaccine that could complement our travel portfolio in the adult sector. And probably more importantly, children in low, medium-income countries. We launched two parallel studies, two Phase II studies, one in infants. The other one is a combined immunogenicity and challenge study, a so-called controlled human infection model. Both are right now ongoing, and we expect for both data mid of the year. So again, a very important milestone for the company. And subject to data, we're going to decide on the program development pathway forward. With that brief update on our portfolio and our key activities, I would like to turn over to Peter to provide us with the financial report.