Thank you. Hello, and thank you for joining us to discuss Valneva's first quarter 2025 results 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 31, 2025, which were published earlier today, available within the Financial Reports section of our investor website. I'm joined today by Valneva's CEO, Thomas Lingelbach; and CFO, Peter Bühler, who will provide an overview and update on our business as well as our key financial results for Q1 2025. 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 the 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, May 7, 2025, and Valneva 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 and good day to all of you. Pleasure to provide the update during today's earnings call. Yeah, the first quarter 2025 was a solid quarter with strong overall financial performance. Total revenues reached almost €50 million. The reduction in operating cash burn is reflecting our continuous focus on cash and cash management. And this is also shown in the cash position north of €150 million, excluding the recent proceeds from our April ATM transaction. And in quarter one, we also made progress on the regulatory front predominantly around IXCHIQ label extensions and further approvals. When we look a little bit more into the details of the first quarter 2025 we got a new IXIARO contract awarded by the US Department of Defense. We responded to the French government's call for IXCHIQ to combat the chikungunya outbreaks in La Réunion and Mayotte. And we responded to the cholera outbreak in Mayotte by supplying doses of DUKORAL. So all in line with our mission to address unmatched medical needs. With regards to the key regulatory achievements that I mentioned earlier, we got the marketing authorization for IXCHIQ in the UK, in individuals 18 years of age and older, and we also submitted the respective adolescent label extension application. We got the IXCHIQ label extension in Europe for individuals 12 years of age and older by the European Medicines Agency. And the IXCHIQ marketing authorization in Brazil represents the first approval of the chikungunya vaccine in an endemic country. On clinical data and pipeline progress, we reported high sustained immune response in adolescents one year after IXCHIQ vaccination with a single dose and as part of our Phase 3. We reported positive Phase 2 pediatric results for IXCHIQ and as such, could decide the dose for the planned Phase 3…

Thank you so much, Peter, for this comprehensive financial report. Turning to Page 24 of the presentation, looking a little bit into our expected growth drivers for 2025 and beyond, of course, it's all about Lyme for the time being. And therefore, we are very much looking forward to the results of VLA15 and, hopefully, its success, which, as Peter pointed out, has the potential for sustained profitability upon approval and commercialization of course, driven by the substantial milestones and royalties kicking in towards the latter part of 2027, according to current timelines and expectations. When we look at the commercial business, we have shown that we have been able to optimize and grow our commercial business. And we expect, in the near-term, continued growth for both of the existing older brands like IXIARO and DUKORAL, but also expect IXCHIQ to gain further global traction. When we look at the future pipeline, we expect really value creation through new pipeline programs and ongoing programs that we have already in the pipeline, including Shigella and Zika. And our goal, as communicated previously, is to have a next Phase 3 program ready post the successful introduction of the Lyme vaccine. With that, we see overall a really good prospect for our business, with, of course, major growth drivers around Lyme, but also major growth expected from our commercial business and upside from future or existing clinical and pre-clinical R&D assets. With that, we would like to conclude our presentation, and hand back to the operator, to take your questions.

Thank you. [Operator Instructions] And now we're going to take our first question and it comes from the line of Maury Raycroft from Jefferies. Your line is open, please ask your question.

Hi. Congrats on the progress and thanks for taking my questions. I'll ask a quick one on IXCHIQ first and then one on Lyme. I guess for IXCHIQ, just wondering what are the next steps regarding the label? Wondering if you've heard back from the FDA regarding the label extension application for adolescents that was submitted a couple of months ago. And then what are the next steps regarding potential need to add new language?

Yes. Thanks for your question Maury. So, I'll start with the last one first. The review with the FDA is still ongoing. So, we have submitted as you rightly pointed out and we are waiting for their reply and hopefully soon, the adoption of the label to include the 12 and above. Yes, the current situation and next steps. At this stage, we have seen changes to the recommendation. You know that we are absolutely committed to the highest standards of safety. So, the investigations are ongoing. We know that all of that has occurred in frail older individuals. We have strongly recommended and continue to do so that health care providers apply individualized clinical judgment when determining the appropriateness of IXCHIQ for elderly frail patients. And we are supporting the regulatory authorities as much as we can on evaluating those cases and we'll review also whether certain additional precautions or contraindications in specific population groups may be warranted.

Got it. Okay. That makes sense. And then for the Phase 3 Lyme study can you remind me what the p-value threshold is for the primary endpoint of confirmed Lyme cases? And when considering GMT from historical studies, how are you setting expectations for the bar and what antibody titer you will need to achieve to get sufficient protection?

So, unfortunately, I can't disclose the p-value for the Phase 3 study, but it is sufficiently powered according to the expectations and according to the I would say epi studies and disease burden evaluations, which most of them got published by Pfizer. And I think that's basically what we can say. I would like to point your attention to a publication -- a joint publication that we also referenced by Pfizer and Valneva where I would say a potential protective immunological threshold has been hypothesized I would say. I think we discussed in length in the past, Maury, that it is very difficult. At this point in time, there has never been an immunological correlate for Lyme. And of course, assays are very different. I mean -- and we can, of course, send you again the link to the respective publication.

Okay. That’s sounds good and that would be helpful. Okay, thanks for taking my questions. I'll hop back in the queue.

Thank you. Now, we're going to take our next question and it comes from the line of Rajan Sharma from Goldman Sachs. Your line is open, please ask your question.

Hi, thanks for taking my question. So, just one on Lyme actually. So, I think you do $143 million in milestones from Pfizer as an initial milestone, I was wondering is that part -- would part of that be due with a potential positive Phase 3? Or is that related specifically to approvals whether that's in the U.S. or elsewhere? And then secondly, I was just wondering if you could just comment on tariffs, which is obviously a focus in the sector at the minute. It would be helpful just to get your perspectives on potential impact for Valneva. Could you just help us understand your manufacturing footprint and any potential mitigations you may have? Thank you.

Peter? Peter Bühler: Yes, hey Rajan it's Peter. Thanks for the questions. So, yes, you're absolutely right. We will -- there is a milestone of $143 million that Pfizer would pay us upon first commercialization. So, it's not at the end of Phase 3, it's -- there are basically three triggers for that -- there are three parts of the $143 million. There is first commercial sales in the U.S., first commercial sales in Europe, and ACIP opinion. And all three events are supposed to happen in 2027 basically. On tariffs -- just to add maybe that there is another -- there will be another $100 million commercial milestones afterwards based on sales thresholds -- cumulative sales thresholds and royalty rates of between 14% and 22% just to remind everybody. On tariffs, it's obviously something we're closely following. I think right now it's difficult to express an opinion on it because nothing has been defined in terms of tariffs. So too many unknowns. We are of course looking at potential mitigation strategy or initiatives. To your question on our manufacturing footprint, so our vaccines are basically all manufactured in Europe. So drug substance for IXCHIQ is manufactured in Scotland and then fill finishing happens in Germany. And as far as DUKORAL is concerned it's all produced in Sweden and the IP is also in Europe.

Okay. Thank you.

Thank you. Now we're going to take our next question and it comes from the line of Vamil Divan from Guggenheim Securities. Your line is open. Please ask your question.

Great. Thanks for taking my question. Maybe a couple on the financial side. So one the sales this quarter were quite a bit higher than consensus to maintain your full year guidance. So I'm just trying to get a sense of the nuances there maybe relative to what you see from consensus estimates right now. Just one in terms of sequencing of the DoD sales that drove the first quarter for IXIARO maybe is that a reason to not be too optimistic on the readthrough to the rest of the year? Or is there maybe some IXCHIQ conservatism built in given some of the label updates that are coming on that front? And then second question just more on the gross margin side. You talked about kind of getting back to these pre-pandemic levels. I think IXCHIQ are one of the key drivers there. Just if there was a shift in sort of uptake of that vaccine, given some of the new label and safety questions, do you still feel comfortable getting to the pre-pandemic levels on gross margins even again if your product mix maybe shifts a little bit? Thanks.

Yes. Thanks for the question. So starting with sales yes, absolutely our first quarter revenues are above the consensus. I think it was expected by us. And as I said in the call, so we did see strong growth in particular on IXIARO on both travel and also DoD. But as I mentioned last year was very heavily impacted by restricted supply that was resolved in April of last year. So you will see this year a slightly different phasing which is also why we do not see right now any change to our guidance. So first quarter for us was in line with what we had anticipated. As you know on sales to the Department of Defense, so we have not published the number. But as you saw we signed a new contract and our supply is ongoing according to plan and it has indeed – has also increased versus prior year. In terms of gross margin, we said in the past that we expect IXCHIQ to over time to yield a better gross margin than the other products. I think that's – we're still looking at – we're still considering this of course. This has not changed. I think overall Q1 gross margin was very good. And you're right we did say in the past we expect to reach a pre-pandemic level although, we have not defined it for 2025, we have not guided on gross margin for 2025. But of course, we're very pleased to see where we were in Q1.

Okay. Thank you.

Thank you. Now we're going to take our next question and it comes from the line of Samir Devani from Rx Securities. Your line is open. Please ask your question.

Hi, guys. Thanks for taking my questions and congrats on a good quarter. Have you now fulfilled the Mayotte order in this quarter?

What did you say?

Did the Mayotte order.

Mayotte yes, so that was the DUKORAL. Yes that was actually fulfilled in the first quarter.

Okay. Fine. And then just on the La Réunion order. Can you help us in terms of thinking how we should phase this in terms of our modeling for IXCHIQ? Is it going to lead to a reasonable spike in the next quarter and then a sort of fall away in Q3? Peter Bühler: Yes. So as we said, we supplied a small number of doses at the end of Q1 and the remaining part will be supplied in Q2 or was already supplied in Q2, I should say.

Okay. And then finally just on the mechanism for IXCHIQ and it being alive attenuated. I'm just wondering Thomas, if you could comment on – has this made you reconsider the sort of dose that you might use in the pediatric studies in light of the potential adverse events you're seeing in the elderly?

It's a quite good question. So we don't see at this point in time any unexpected safety profile in younger, adults or even adolescents. So at this point in time we have not reconsidered the dose for the Phase 3 infant study that we had previously announced but as I said at this point in time. So that's all I can say for now.

Okay. That's great. Thanks very much.

Thank you. Now we'll proceed with our next question and the question comes from the line of Suzanne Van Voorthuizen from Van Lanschot Kempen. Your line is open. Please ask your question.

Hello. This is Samuel on for Suzanne. For the Lyme Phase III program and the last tick season now starting can you provide some color on the infection rate so far in the study? And is this monitored and in line with the company's expectations? And secondly with the study consisting of two sequential cohorts of subjects is the first cohort receiving a second booster this season already? And will you report data on this too at the year-end readout? And then lastly regarding the latest news that came from vaccine policymakers could you comment which elements may or may not affect your vaccine business? And do you see particular risks or opportunities there?

So many questions. So thank you for that. So I would say, we have not -- yes, we are of course monitoring on an ongoing basis the overall Lyme cases during the study. We are and will not comment on those other than we have seen the overall profile over the past couple of years being pretty consistent in terms of number of line cases. And we see at this point in time no concerns. With regards to the study cohorts the answer is no. With regards to the other activities that you were mentioning mainly impact on the business. I mean, at this point in time probably no one is able to really say what all these political dynamics in the United States mean with regards to any of the vaccines on the market or in development. And I think we should probably not speculate about that. And will it have an impact? Probably yes, probably not. So I think, we have to wait until certain things become more defined and turn into real requirements or policies.

Thank you. Now we will take our next question and it comes from the line of Oscar Haffen Lamm from Bryan, Garnier & Co. Please ask your question.

Thank you for taking my On the first one on IXIARO. Relative to Q4 last year sales roughly similar. So I was just wondering if there were any seasonality effects seen during this first quarter. And then maybe how do you forecast the growth of the asset for the remaining of the year? Peter Bühler: So on IXIARO like I said, the impact is more quarter-over-quarter. I don't think there is any particular seasonality impact in Q1 except as I mentioned also, particularly in one of our indirect markets there's probably some stocking effect. But in the overall picture, I would not say, it's absolutely material. And I'm sorry, I didn't get the second question. Can you maybe repeat that one? Q – Oscar Haffen Lamm: Yes. Just how do you forecast the growth of IXIARO for the remaining of the year? Peter Bühler: Yes. So, we have not guided specifically on IXIARO. But what we did say is, we expect IXIARO to continue to grow a double-digit CAGR, which we would expect for this year double-digit growth. But we have not guided specifically, on the number for IXIARO. Q – Oscar Haffen Lamm: Okay. Thanks and maybe quickly a second question this time on IXCHIQ. I was wondering, if following the updated recommendation from the French HAS, there could be a potential impact related to the order book of vaccines that were ordered for the outbreak in La Réunion.

We have at this point in time confirmed the 40,000 dose order and we delivered the 40,000 dose order and all the rest we have to see. Q – Oscar Haffen Lamm: Okay. Thank you.

Thank you. [Operator Instructions] And the question comes from the line of Simon Scholes from First Berlin. Your line is open, please ask your question. Q – Simon Scholes: Yes. Good afternoon. Thanks for taking my questions. I've got three. First of all, I was wondering if you could give us some color on the idle capacity costs, and your efforts to reduce these. And secondly on the IXIARO gross margin, which was 73% in Q1. I mean, do you think the gross margin on IXIARO is sustainable at this level? And on the DUKORAL gross margin, do you expect that to be able to get that closer to 60% over time? Thanks. Peter Bühler: Yes. So let me start with the gross margin questions. So on IXIARO, we do think that Q1 was probably not representative where it will be for the full year. We do expect an improvement of course versus prior year. But I think north of 70%, I think is probably not what we will see for the full year. I think on DUKORAL, we haven't -- I haven't yet guided on their gross margin, but I think the Q1 gross margin is probably roughly representative. On the idle cost, so for the first quarter I would say, it was probably roughly around €2 million. And so this is primarily related of course one, because we have large capacity but also because some of the -- especially the new manufacturing site in Scotland we are in progress of transferring over production. So over time we will see a reduction in that idle cost of course. Q – Simon Scholes: Okay. Thanks very much.

Thank you. Dear speakers, there are no further questions for today. I would now like to hand the conference over to the management team for any closing remarks.

Thank you so much for your attention today. Good questions as usual, and your interest in following the company closely and we are looking forward to staying closely in touch, while we are focusing on our execution this year to build strategic value for the future. Thank you so much.