Valneva SE

Good day and thank you for standing by. Welcome to the Verliva nine-month 2025 financial results conference call and webcast. 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, please 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 note that today's conference is being recorded. I would now like to have the conference over to your first speaker, George Drum. Please go ahead.

Thank you. Hello, and thank you for joining us to discuss Del Nivo's financial results for the first nine months of 2025 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 nine months ended September 30th, 2025, which were published earlier today, available within the financial reports section of our investor website. I'm joined today by Vanneva's CEO, Thomas Lingelbach, and our CFO, Peter Buehler, who will provide an overview and update of 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 and uncertainties that could cause actual results 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, November 20th, 2025, and Veneva 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 so much, Josh. Good day, everyone. Welcome to our nine months call. So before we go into the business highlights and also Peter will provide a very detailed financial report, I would like to start off by providing a couple of key financial management highlights. Total revenues reached 127 million euros at the nine month time point. which is this essential growth of almost 9% despite of some headwinds, be it from a geopolitical perspective, but also from an industry perspective in particular. And we are very glad that we have been able to deliver on that growth year to date. We have also been able to significantly reduce our operating cost cash burn which has been one of our key objectives in continuously improving efficiency of our operations. This resulted in a cash position of more than 140 million euros, which includes also the net proceeds from different ATM transactions. Peter will further detail. And most importantly, we successfully managed completed our debt refinancing, which, of course, enhances substantially our financial flexibility. And we are very glad that we have found in Pharmacon a new partner to support Valneva in the years to come. Recapping a little bit on the first nine months, keep this in the highlights. Around ICCHEC, we responded to significant unmet medical needs on the La Réunion and Mayotte, the respective outbreaks. We also responded to a cholera outbreak in Mayotte by supplying doses of Ducoral. And we again finalized the new ICCHERO U.S. Department of Defense contract. All of that supporting our mission in targeting unmet medical needs. On the regulatory and commercial side of things, we secured additional marketing organizations for H-CHIC in the UK and Brazil, label extensions for adolescents 12 years of age and older in Europe and Canada. And we announced an exclusive vaccine marketing and distribution agreement for Germany with CSL Sequerius replacing Bavarian Nordic by the end of this year for our established brands, and they already started distributing Ixchic in Germany. Of course, on the clinical side, it's all about Lyme right now. We completed all vaccinations in the Valor phase three study according to plan. We also reported further positive safety and immunogenicity data following the third annual booster as part of our phase three follow-up study, VLA 15 221. On ixchic, the vaccine profile got further substantiated with the antibody persistence data now after four years still showing the 95% zero response rate after a single shot, which is the key differentiation for this live attenuated single shot vaccine. We further reported, you know, immune response in adolescents and positive pediatric safety and immunogenicity data Last but not least, we also reported positive phase one results from our second generation Zika vaccine candidate VLA-1601. Going a little bit into the details of the individual programs, I would like to start off with Lyme. We've been talking a lot about Lyme and we will be talking a lot about Lyme. The Lyme continues representing a major unmet medical need, enhanced market opportunity, close to half a million cases every year confirmed in the United States. Probably now in Europe, the same order of magnitude, although there are limited reporting systems available. Remember that we have about 90 million US citizens living in high-risk areas of Lyme disease, and in Europe, more than 200 million in those endemic regions. Most importantly, the health economic benefit for potential vaccination against Lyme disease is considered extremely favorable. Why? Because you have very severe manifestations in connection with Lyme disease, 10 to 30% of people develop either carditis, neuropoleiosis, or arthritis, and 5 to 10% persistent symptoms, even following treatment with respective antibiotics. By way of reminder, around the phase three study that is currently ongoing, Pfizer reconfirmed that they're going to submit regulatory applications in the US and Europe in 2026. The Valor study has been executed according to plan. And basically Pfizer guided for readout in the first half of 2026. And the study, of course, is now going through its follow-up period since the official case count ended at the end of October. Then we run the normal process through case adjudication, further testing activities, database cleanings, and all of that before the results will be announced in the first half of next year. Most importantly, The time point for which we expect the product to be launched hasn't changed. It is important for us and our colleagues that the product can be launched in the autumn of 2027, well ahead of the 2028 tick season. It is important to get really people protected for the tick season. As such, we are very, very much looking forward to the data, which hopefully are going to be positive and hence provide a pathway for a vaccine that could really address a huge unmet medical need. Turning to our highly differentiated single-shot Chikungunya vaccine VLA1553 or iX-Chik. You know, where are we at this point in time? Of course, we have on the regulatory side still the situation that the product is suspended in the United States, and we are still awaiting further information from FDA, which we haven't received at all at this moment in time. In all the other countries, we are working on the basis of updated prescribing formations or SMPCs, and we are seeing that the product is being administered, and we are trying to focus substantially on the expansion into LMRC territories and are working with existing and hopefully future partners in this regard. The most imminent point now to consider in this program that is supported by CIPI are our post-marketing effectiveness studies, the phase fours, which are about to commence with an observational effectiveness study in Brazil with pragmatic randomized control effectiveness safety studies in adolescents and adults, including elderly, in various endemic countries, and then later a prospective safety core study and surveillance in Brazil as well. Of course, I mentioned already the label expansions and, you know, the reports on the positive data, which we will further submit and hopefully be granted in the different product labels. We see clearly the product differentiation for XGIC, which, of course, is Super important for a potential outbreak disease and for people who are planning multiple trips into areas where there is a high risk of a potential outbreak. Shigella. You may recall that we in-licensed the vaccine through a partnership with Lima Tech, the program called S4V2. is the world's most technically advanced tetravalent Shigella vaccine candidate. It addresses the four most common serotypes of the Shigella bacteria. The program reported earlier positive 1, 2 clinical data in different age groups. In terms of medical needs, Shigella represents the second leading cause of fatal diarrhea, and here especially in infants below five years of age. The global market is expected on the one hand side in LMICs, in particular the target population that I just mentioned, but also it represents significant opportunity for travelers and military Given the overall medical need and also the diarrheal diseases to be seen in the context of antibiotic resistance, the Shigella development or vaccine development against Shigellosis has been identified as a priority by WHO. We have currently a couple of studies ongoing. We have the phase two. In instance, for which we expect results still this year, and we have the phase 2B controlled human infection model study in adults, where we changed some of the, you know, data, time points, the clinical design in order to extend the period of immunogenicity where we had the opportunity to optimize those and schedule. And we expect the pilot efficacy data next year with immunogenicity data coming in earlier upon success. And please remember that we have intentionally set up the clinical design and clinical pathway in a way that the program is highly de-risked from a capital allocation perspective. So based on positive data, based on our respective goal decisions, we will assume full accountability for the program following those two studies, which are still sponsored by LIMASEC. With this update on our operational business and R&D in particular, I would like to hand over to Peter to provide you the financial report for the nine-month period.