Valneva SE

Good day and thank you for standing by. Valneva presents its half-year 2026 financial results. 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 today's conference is being recorded. I would now like to hand the conference over to your speaker today, Joshua Drumm, VP of Investor Relations. Please go ahead.

Hello, and thank you for joining us to discuss Belneva's financial results for the first half of 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 six months ended June 30th, 2026, which were published earlier today, available within the financial report section on our investor website. I'm joined today by Velneva's CEO, Thomas Lingelbach, and our CFO, Peter Buhler, 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 and uncertainties that could cause actual results to differ materially from those expressed or implied by these forward-looking statements. You can find 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, August 13, 2026, and Velneva 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. Let me start off with a couple of introductory remarks. The first half of 2026 has certainly been marked on our effort to focus on enhancing our financial position, especially after the initial Lime Phase III Valor results and the resulting uncertainty. And we have been able to generate a strong cash position with more than 120 million euros in cash. This is a result of our disciplined cash management and the proceeds from the recent offering. We also included a broad restructuring program and we expect the positive P&L and cash flow impacts in the second half of this year and of course beyond. This included A reduction in our workforce, a reprioritization of projects, activities, and a focus on our core operational business. When we look at our general commercial business performance, we generated more than 60 million in total product sales. We have reaffirmed the guidance because the half year sales performance is in line with our anticipated pacing of product sales throughout the year We have had a number of adverse EBIT impacts in the first half of the year. Peter will explain those in greater detail. Most of them are really one-off effects and are non-recurrent. But the most important thing and the most exciting thing is that Pfizer continues to be very positive about the prospect of the Lyme disease vaccine. and they recently announced during their earnings that they expect regulatory decisions for the Lyme disease vaccine candidate in the next 12 months which is really great news. Now turning to our general business update and of course I would like to start with Lyme. You know that the vaccine showed a very strong point efficacy, greater than 70%, a very good safety profile and As we discussed multiple times, we had a miss on the lower bound of the 95% confidence interval. However, we have to note that we see here with this product candidate a very significant, meaningful efficacy and we had also 95% confidence interval lower bound greater than 20% in the second pre-specified analysis. All of that in combination with the huge unmet medical need, the totality of clinical evidence, and the fact that we really expect a positive health economic benefit for a potential prophylactic solution increases our confidence in the future prospect of a potential Lyme vaccine. There is a huge unmet medical need. We have discussed this many times in the past The annual burden of disease is increasing, and we have been noting recently close to 500,000 cases in the United States. Europe, I mean, numbers are, you know, kind of still significantly underreported because not all countries have respective surveillance systems, but certainly north of 100,000 cases every year. Some of them come along with very severe manifestations in the order of 10 to 30% caditis, neuroboriosis, arthritis. And unfortunately, 5 to 10% of cases continue to have persistent symptoms even following treatment. As such, we really believe that LB6V, how it's called now, is a compelling opportunity in a highly underserved market. We could really leverage a first mover advantage. The perception around a need for Lyme vaccination is high. We have the only Lyme disease vaccine candidate in late stage clinical development. And it could become, if licensed, the first potential Lyme vaccine in nearly 30 years. The vaccine is based on a proven mode of action. We cover the six key serotypes prevalent in the Northern Hemisphere, and the technology is based on modern state-of-the-art recombinant protein technology. We have a broad, addressable population. At this point in time, we showed in the study results for people above five years of age, I mentioned already that we see a growing disease burden and of course with global warming the tick population across all the high-risk areas of Lyme disease are steadily increasing. We have an excellent partner and there is a huge strategic fit with Pfizer's vaccine franchise and hence we anticipate a very attractive commercial prospect and dynamic. So all in all, we share Pfizer's positivity on the prospects of that vaccine, and we really hope that we can get this vaccine to licensure on both sides of the Atlantic. On HCHIC, as part of our overall restructuring process and also reprioritization of our key strategic focus area, We shift more and more towards the ixchic access in countries where there is highest risk for chikungunya infection, meaning primarily low and medium income countries. And we are currently executing on a significant number of post-marketing activities. all supported by our great partner CIPI. We have a pilot vaccination campaign ongoing in Brazil. We have more than 50,000 people already vaccinated today. These are adults 18 to 59 years of age. We have a study ongoing to confirm effectiveness and optimize description of the safety profile, which of course over time could potentially even lift the highly restrictive warnings, precautions, and other indications we have right now in our label for travel. All of that, of course, to ensure greater access, and we are focusing a lot right now on expanding our network of manufacturing distribution card partners in low- and middle-income countries and we hope that we will be able to even announce something towards the latter part of the year. The locally manufactured vaccine in Brazil by our partner Butantan has now been approved and is expected to be incorporated into Brazil's public health system in the near future. We in-license an interesting candidate against Shigellosis. It's the most clinically advanced tetravalent Shigella vaccine candidate. Right now, we are running two studies, one in infants, the other one in adults. One is an immunogenicity and safety study. The other one is a controlled human infection model study, so pilot efficacy through human challenge. We expect for both studies results in the coming months. And of course, based on the results, we will decide on the next development steps for that vaccine. Of course, there is still a significant market opportunity for shigellosis, especially given that it's the second leading cause of fatal diarrheal disease and estimated with 165 million cases and 600 deaths annually. Mostly, of course, in children in LMIC countries, but there is also a very interesting opportunity to either in a standalone setting or in a combination vaccine setting to work towards a product covering diarrheal vaccine for travelers. With this short update on our core R&D activities and general business development, I would like to hand over to Peter to provide you with the financial report.