VALN

Good day, thank you for standing by. Valneva presents its first quarter 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 one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one 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, Vice President, Global Investor Relations. Please go ahead.

Hello, and thank you for joining us to discuss Valneva's financial results for the first quarter 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 Bühler, 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 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 13th, 2026, 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. Good day, everyone. Our first quarter was certainly dominated by the Lyme 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 EUR 30 million. 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 pacings, 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 Lyme, 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 EUR 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%-15% and aims to result in a significant 25%-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 miss 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 that we have observed fewer than anticipated Lyme disease cases that were grouped 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 authorities. 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. We all acknowledge that those reported numbers are probably heavily underreported. Clinically, Lyme comes with different clinical manifestations. 10%-30% of the individuals develop either carditis, neuroborreliosis, or arthritis. Some, namely 5%-10% of 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, you know, individuals in the study aged 5 years and above. 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 regards. There is, of course, a strong strategic fit with Pfizer's existing business and franchise.

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 IXCHIQ 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 is progressing quite nicely. We have a very significant pilot vaccination campaign ongoing in Brazil. The vaccine is being given to adults age 18-59 years of age, and the objective is to reach a 20%-40% coverage within this target population across various municipalities in Brazil.

We have already vaccinated more than 30,000 people to date. 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 achievement in the endeavor that is supported by CEPI and for which we are grateful on advancing this vaccine and advancing access into countries and for countries who can really benefit from it. Few words on Shigella and our shigellosis program. It is certainly one of the most advanced, if not the most advanced, tetravalent vaccine candidate against shigellosis. We are targeting the four most common pathogenic Shigella bacteria. Previously, our partner LimmaTech 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 pilot efficacy study, so-called controlled human infection model. For both, we are expecting the first readouts or the readouts over the summer.

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, that 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. Overall, a lot going on on our, you know, key R&D and business activities. With that, I would like to hand over to Peter to provide us with the financial report.

Thank you, Thomas. Looking at the financial report for the first quarter of fiscal year 2026. Product sales reached EUR 30.5 million compared to EUR 48.6 million one year ago. IXIARO sales were EUR 20.2 million compared to EUR 27.5 million in the first quarter of 2025. The year-over-year decline is primarily a result of a difference in the phasing of scheduled deliveries to the U.S. Department of Defense. Deliveries in the first quarter of 2026 have continued under the current contract signed in January 2025. DUKORAL sales reached EUR 8.6 million compared to EUR 12.3 million in the first quarter of last year. The prior year included one-off sales related to the supply of doses to Mayotte following a local cholera outbreak.

In addition, DUKORAL sales in the first quarter were adversely impacted by the change in our distribution partner for certain EU countries, mainly Germany, which represents a substantial travelers market. This change took effect from January 1 and included the transfer of residual inventories, which in the case of DUKORAL, were sufficient to satisfy the demand for the current first quarter. We expect new product deliveries to resume in the second quarter of 2026. IXCHIQ sales reached EUR 1.6 million compared to EUR 3 million in the first quarter of 2025, which had benefited from first treatment of doses to French island La Réunion in response to a major outbreak, as well from travel sales in the U.S.

Third-party products were reduced to EUR 100,000 compared to EUR 5.8 million in last year's first quarter. This decline reflects the intentional wind down of third-party product distribution to increase the focus on our proprietary products. Now with moving on to the income statement. We reported total revenues of EUR 30.9 million versus EUR 49.2 million in the first three months of 2025. Other revenues remained largely unchanged year-over-year. cost of goods and services were EUR 26.2 million versus EUR 21.3 million in the prior year. The increased cost of goods, despite lower sales, were a result of several factors. Idle costs increased compared to one year ago following the completion of the manufacturing transfer to the new Almeida facility.

The cost related to failed batches and inventory provisions, in addition to onerous contracts related to IXCHIQ, significantly exceeded the cost observed in the first quarter of the prior year. Additionally, cost of goods in the first quarter of last year were particularly low due to positive impact related to standard cost adjustment. In the first quarter of 2026, the gross margin on commercial product sales, excluding IXCHIQ, was 45.2% compared to 62.7% for the three months ended March 31st, 2025, or approximately 50% for the full year of 2025. IXIARO's gross margin reached 50.8% compared to 72.6% in the first quarter of 2025. The decline was driven by higher manufacturing costs following the transfer of production to the Almeida facility, increased batch write-offs, and lower overhead absorption due to lower sales.

In addition, as already mentioned, last year's first quarter had a significant positive impact related to standard cost revaluation. For the full year of 2025, the IXIARO gross margin reached 59.6%. The gross margin of IXCHIQ was negative, impacted by cancellation fees related to external manufacturing commitments following lower than anticipated sales. Additionally, cost of goods include idle capacity cost and cost not allocated to products of EUR 5 million. We expect gross margin to normalize and improve following one-off effects in the first quarter of 2026. Research and development expense for the first quarter remained stable year-over-year at EUR 15.2 million, mainly representing investments into IXCHIQ and Shigella, as well as our preclinical EBV project. Marketing and distribution expenses in the first quarter reached EUR 7 million compared to EUR 10.4 million in the prior year.

The decrease is mainly related to lower spend on IXCHIQ, in particular in the U.S. General and administrative costs decreased to EUR 8.2 million compared to EUR 9 million in the prior year. The decrease is related to lower people cost as well as savings in professional services. The operating loss for the first quarter of 2026 is reported at minus EUR 23.7 million, driven by lower sales and gross margin. Net finance and income tax expense is reported at EUR 8.4 million compared to EUR 3.3 million in the prior year. The increased expense is driven by a foreign exchange loss of EUR 3 million compared to foreign exchange gain of EUR 3.7 million in the prior year.

With this, the loss of the first quarter of fiscal year 2026 reached EUR 32.1 million compared to EUR 9.2 million in the prior year. A word on cash. As mentioned at the beginning of this presentation, total cash and cash equivalents at the end of March were EUR 105 million compared to EUR 110 million at the end of the prior year's fiscal year. In the first quarter of 2025, we continued to reduce the cash used in operations compared to the prior year. Cash at the end of March does not yet include initial proceeds from our successful reserved offering completed in April 2026. Moving to the next slide to review our guidance for the fiscal year.

In light of emerging adverse trends in travel vaccine uptakes across our key markets driven by geopolitical factors, we adjust our product sales guidance to EUR 135 million-EUR 150 million for the fiscal year 2026, and total revenues to EUR 145 million-EUR 160 million. In April 2026, we initiated a restructuring plan to streamline our business operations and focus our resources on key projects. As a result, we plan a global workforce reduction between 10%-15%, and expect an overall reduction in our operating expense of about 25%-35% compared to the level of 2025. This concludes the finance section of this call. I would like to hand back to Thomas.

Thank you so much, Peter. Yeah, to conclude our presentation, talking a little bit about the future. Of course, and as I mentioned during the introduction, and Peter reiterated this during the financial report, while we are living through the period of uncertainty regarding the Lyme vaccine candidate, we will of course do everything to focus on our base business to make sure that we advance the key strategic projects and activities, and that we contain cash to the maximum level possible. However, we plan for Lyme success, and we plan for a successful outcome of the Lyme process that will be run by Pfizer with the respective regulatory authorities. If successful, it would offer Valneva very significant strategic growth opportunities.

In such a case, we want to leverage our core strength in vaccine development, because this is where we believe we will be able to deliver greater long-term value. Our focus will be to build scale in the R&D pipeline, post VLA15 and post successful, you know, approval and commercialization. We'll do this by combination of organic and inorganic, meaning strategic growth in the pipeline. We clearly would like to expand and extend beyond our initial investment thesis when we created the company, namely vector-borne diseases. You have seen that some of our preclinical activities, especially EBV and also the enteric disease focus, point in, already in this direction.

Of course, we will continue, as we have done last year, and we will do so this year again, to optimize our business operations, be it on the commercial, but also be it on the manufacturing and supply side, all to generate as much cash with the commercial business as possible. With this, I would like to conclude our update and give back to the operator to take your questions.

This question comes from the line of Maury Raycroft from Jefferies. Please go ahead.

Hi. Thanks for taking my questions. I'll ask a couple on the Lyme program. I know there's a degree of uncertainty there, but wondering if there's any perspective you can provide on the status of Pfizer's pre-BLA meeting request with FDA and whether a meeting date's been scheduled and potentially what timing for that meeting could look like.

Hi, Maury. Thanks for the question. You know, Pfizer are preparing for respective meetings. More we cannot state and say at this point in time, unfortunately.

Okay. Understood. Wondering if you can help us understand how Pfizer plans to present the totality of clinical evidence to FDA, including cases that were adjudicated out, and whether there's been any discussion around reevaluating outcomes under less restrictive clinical criteria. We've discussed how you guys have used a stringent definition, and so wondering if there's any perspective on that.

Maury, unfortunately, I can't comment to that.

Understood. Okay. Maybe one other quick clarification question. Once Pfizer has the BLA meeting scheduled, they have the BLA meeting, do you know if there will be a disclosure around the BLA acceptance or how logistics could work going forward?

Our current hypothesis is that file acceptance will be disclosed.

Got it. Okay. Thanks for taking my questions. I’ll hop back in the queue.

Thank you. Our next question comes from the line of Suzanne van Voorthuizen from Kempen. Please go ahead.

Hi, this is Romy on for Suzanne . Thanks for taking our questions. The first is on IXIARO growth dynamics. I was wondering if the decline we saw for Q1 of this year was solely driven by phasing with the U.S. DOD, or was there also contributions from the private travel markets? A follow-up there, for the full year 2026 guidance adjustment, is this primarily based on your thinking of the general travel dynamics expected this year? Thank you.

Let me take the question first and then, you know, possibly Peter can complement. I think as we said during our report, it's a combination of various factors. Certainly the major contributing factor, as reported by Peter, has to do with phasing of supplies to the DOD, our single largest customer for IXIARO. You know, the supply schedule and the phasing is different year-over-year, and it's very hard to predict the exact supply schedule. That makes always this quarter-to-quarter comparisons really difficult. There is, however, also a contributing point around reduced travel.

Peter presented very clearly that this is the root cause for and the major cause for why we have been taking a prudent stand and revised the guidance down by EUR 10 million. It is not that we see already a huge impact in quarter one, but what we are observing is really a reduced level of travel into the geographies which are very important for our travel vaccines. This is also supported by airline data, and we see this trend emerging. So the, that's, I think, all we can say with regards to the dynamic of IXIARO. Peter, please jump in if you wanna add anything.

Yeah. I think the only other thing to add is, and to a lesser extent than the shipments to U.S. military, there is this impact on the indirect markets with the shifting of distributors, where we see a slight impact, not as much as in DUKORAL, but we see a little impact also on IXIARO. This is more just, you know, technically the switchover from to a new partner, right?

Thank you.

Thank you. We will now take our next question. This question comes from the line of Vamil Divan from Guggenheim Partners. Please go ahead.

Great. Thanks for taking my questions. Maybe a couple more on the Lyme front, and appreciate you may not be able to answer all these fully right now. One, I'm curious when you think the full data would be released for us to review it in totality. Second, I'm wondering, are there other examples you can point us to with vaccines where there's been this situation where the pre-specified or first primary endpoint of the trial was not met in terms of the confidence interval, and the vaccine was still approved? Are there any sort of comps that you can point us to to give confidence on this still getting through?

Just on the event rate, I'm curious if you can comment on the event rate being lower than what you saw or what you expected. Does that in any way sort of impact what you think in terms of the commercial opportunity for this vaccine or the interest in the amount of events that are about happening in the community? Is there any change to your views based on what you saw in terms of how many people, you know, acquiring the disease during the trial? Thank you.

Let me start from the back to the front here a little bit. I mean, as we reported in the press release, the total N, meaning the total number of reported, and adjudicated cases, was certainly lower than anticipated, which resulted in this wide, spread, confident, interval, lower and upper. We don't necessarily, see this with regards to what is happening in, the high-risk areas of Lyme and Pfizer are certainly doing that, as we speak.

With regards to, you know, other vaccines, there are, you know, there are a few reports and publications that were made in, you know, in two different channels, including social media, analyst reports, where people focused on, you know, situations that may have been not similar but probably comparable. I mean, there were reports around a flu vaccine called Fluad. There were reports around one of the RSV vaccines. There were also references made to the, you know, immunobridging in the pneumo development areas. You know, we don't think that I mean, all of that is certainly Probably indicative. By the end of the day, I don't think that there is something that one can really compare like for like. In the world of vaccine development, you need to really review whether the results are clinically meaningful, and this is certainly the case. Then, you know, it's a review of the totality of clinical evidence and data that will certainly be facilitated by Pfizer in the best possible and you know, optimal way. To your question about where and when will the data in totality be presented, Pfizer stated that they will present the full dataset at a forthcoming conference. To my knowledge, it has not yet been confirmed which one this is going to be.

Okay. Thanks for the information. Thanks.

Thank you. Our next question comes from the line of Damien Choplain from Stifel. Please go ahead.

Yes, hello. Thank you for taking my questions. I have a couple of questions on the restructuring plan. Can you elaborate on how the savings will phase through the year, and how should we think about the split of savings between R&D and SG&A? The last one, when do you anticipate achieving full payback from the program? Thank you very much.

Thanks for the questions, Damien. In terms of timing, a lot of the redundancy we're looking at or when we look at people cost, a lot of the redundancy we're looking at are in Austria, there's a clear legal process. Actually this will continue for a while. Similar to other European countries, there will be notice periods. The full payback will certainly only be that next year on that. We initiated the process now with the Austrian authorities, I think information to staff will occur approximately in 1 month from now.

I think when it comes to external spend, this is actually initiated now, and we will, we do expect a significant savings for the, for the remainder of 2026 and then of course carried over into 2027. Between R&D and SG&A, sorry, most of the savings we'll expect in R&D, as opposed to if we compare to 2025, right? In, in sales and marketing, it's gonna be more or less cosmetic in line with kind of the adjustments we did to the top line. In G&A, it's in a way a continuation of savings we've already seen in 2025 versus prior year.

we will add on some savings, but it's not gonna be as substantial as in R&D of course.

Okay. Thank you very much, Peter.

Thank you. Our next question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead.

Hi. I've got a couple of questions. Sorry to labor the point on the, on the Pfizer part, but I was just wondering what level of insight do you actually have into Pfizer's FDA discussions? Is it essentially the same as everybody else in the market where you get the update when Pfizer discloses it? I had a couple of financial questions which I can follow up with.

We are not actively involved in the preparations or discussions in between Pfizer and regulatory authorities. But we have a process to be informed through existing steering structures, you know, at different time points than as compared to the market.

Okay. Got it. Thank you. Couple on the financials. Peter, I think, well, you guided to normalized gross margin for 2026. Could you just help us understand what a normalized gross margin is for Valneva and what the impact of idle capacity costs might be? In 2025, you had EUR 10 million of idle capacity costs and you've reported EUR 5 million already in first quarter of 2026. I think at full year results you mentioned that idle capacity costs in 2026 will be similar to 2025. Is that still the case? Secondly, just on the outlook for revenues, can you just help us understand or reassure that there's no further downside there? Looking at the midpoint of your new guidance range, that's about implies around a 12% decline versus 2025.

In Q1 2026, you've seen a 26% decline, I think third party products will trend down. It sounds like the travel market slowdown that you mentioned was not fully realized in Q1. Yeah, could you just help us understand those dynamics and provide some reassurance that there's not further downside there? Thank you.

Yeah. Thank you, Rajan. On gross margin, normalized gross margin. You know, it's of course work in progress in a way, but we would expect that we probably get close to where we were for the full year 2025 for the rest of the year. In terms of idle capacity, it is a bit higher than last year. It's not the full EUR 5 million. We said the EUR 5 million is idle plus some unallocated costs. Most of the EUR 5 million is It is idle and it is higher than last year just because we transitioned over to Almeida and are now fully utilizing the Almeida facility, which increased, you know, part of the idle capacity because of the pure size of this manufacturing site. When it comes to revenues, I mean, we think we have a realistic guidance now. The range we gave, EUR 130-EUR 150. You know, where we will land in this range, we can't say, of course, that's why we gave the range. Right now we feel comfortable that it's appropriate. You know, what happens for the remainder of the year in terms of geopolitical situation, we can of course not give any guarantee.

I mean, if the overall situation in, especially in the Middle East, gets worse and the travel market gets affected, you know, we cannot exclude it will have an impact. As for from where we stand today, we think it's a realistic assumption, you know, the range.

Thank you.

Thank you. We are now going to take our next question. This question comes from the line of Brandon Folkes from H.C. Wainwright. Please go ahead.

Hi, thanks for taking my questions. Just changing gears here a little bit, and focusing on the Shigella phase II readouts. You know, what are you looking for in this readout? How will you assess the go-forward decision, and has that bar changed given the focus on OpEx reduction? You know, maybe just looking a bit further out on this, you know, if you were to commercialize that product, would you be selling to the same core points as DUKORAL? Can you just talk about the commercial synergies of a Shigella and cholera product? Thank you.

Thank you so much. Glad that we are able to talk a little bit about Shigella for a change. First of all, you know, the thing that we really like about this program is that through the controlled human infection model that is currently run through at Johns Hopkins, we will get title efficacy. We are challenging people with one strain, namely the Shigella sonnei strain. What we hope to see is, A, that the challenge model works, meaning that people above a certain immunological titer are being protected and others not. That we see really an effect on placebo versus vaccine in this model.

Ideally, a first indication about the immunological threshold that needs to be reached in order to see protection. On the children side, we hope to see that, you know, we see a solid immunogenic immunogenicity profile, good zero response rates, and that we have a first idea about the schedule and whether this two-dose schedule in children will be sufficient or not. This is what we expect to see from those studies. It is hard to say, to predict right now what the outcome is going to be. The good thing is, you have a huge de-risking in case of positive data.

Therefore, you know, once we see the data, we are currently anticipating that we will need to turn an additional round around, you know, optimizing probably dose, schedule and so on and so forth, and anticipate those things to commence literally next year. I think there is currently no strategic change with regards to the Shigella program in connection with our restructuring activities. I would say there is probably a bit of a different phasing or pace associated with it as compared to, you know, previous hypothesis. Strategically, and focus-wise, we don't see a real, you know, difference. Now, coming back to your question around commercialization, which is a very good one. You know, Shigella, and shigellosis, has 2 key potential markets.

By far the largest medical need and commercial opportunity sits in emerging countries and in low, medium income countries where, you know, this is a disease with a huge mortality burden, and therefore a very, very relevant risk-benefit and health economical benefit. Here, you know, in the ideal world, one would target step-by-step a multivalent vaccine covering more than just shigellosis. Combination vaccines that could potentially also include, you know, ETEC, cholera, and other components. But as a second step. I think those combination vaccines in the enteric disease field is would certainly represent a huge commercial opportunity. We see the introduction in those emerging markets as a first step, really as a stepping stone. The second part is travelers.

There is a clear need for a Shigella vaccine in travelers. Again, you know, in the ideal world, you would have a combination vaccine to create more and more coverage in order to be able to provide a quote-unquote traveler's diarrhea vaccine. In order to present a traveler's diarrhea vaccine, you will need to add additional antigens above and beyond even, you know, cholera and ETEC. Again, it's a stepwise approach. Whether or not Shigella, standalone, will be, you know, directly, you know, licensed and commercialized in travelers or whether we're gonna focus on combination right away is something that we are exploring. It will be part of our review in connection with the future development plan for Shigella.

Please keep in mind that we announced previously that we are working on enteric diseases also in our preclinical arena. We are working on a broad covering ETEC vaccine candidate, for example, covering both LT as well as ST. Of course, with that, plus our cholera vaccine in hand, we in a way set ourselves up for potential combination vaccines in the traveler's diarrhea environment. I hope this answers your question.

Yes, that was very helpful. Thank you very much.

Thank you. As a reminder, to ask a question, you will need to press star one and one on your telephone. We are now going to take our next question. This question comes from the line of Simon Scholz from First Berlin Equity Research. Please go ahead.

Yes. Hello. I've just got one question. You wrote in the 2025 20-F that you'd received a letter from the FDA, preventing you from using the Almeida facility to produce IXIARO for distribution in the U.S. I was just wondering if you could outline current measures to mitigate that and also give us some idea as to whether this will impact sales of IXIARO or your capacity to supply the Department of Defense with IXIARO.

First of all, yes, you're right. We received a Form 483 as part of the pre-approval inspection and a complete response letter with regards to the pre-approval supplement of Almeida as an alternative site for IXIARO manufacturing. We have, however, received approvals for the new manufacturing site from all the other, you know, regulatory bodies. We were, you know, kinda smart enough to, you know, file Almeida as an additional manufacturing site, and the existing facility is still active. I think this is important to note, and we are releasing product out of the previous facility or the existing facility called Solna into the U.S. market as we speak.

Of course, we are working with the FDA to address their concerns articulated in the Form 483, and we'll resubmit the pre-approval supplement process, you know, as soon as we can.

Okay. You don't expect any impact from temporary inability to use Almeida on IXIARO itself in the U.S.?

Not at this point in time.

Okay. Thanks very much.

Thank you. That was our final question for today. I will now hand the call back to Thomas Lingelbach for closing remarks.

Thank you so much for your attendance today, great questions, and for following Valneva. As we said during the call today, we are looking forward, especially to the next steps in connection with the Lyme vaccine. I'm confident in the prospect of not only Lyme, but also Valneva. Thanks a lot.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Good day, and thank you for standing by. Welcome to Valneva's full year 2025 results and business update 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 one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please note that today's conference is being recorded. I would now like to hand the conference over to your speaker, Joshua Drumm, VP of Global Investor Relations. Please go ahead.

Hello, and thank you for joining us to discuss Valneva's financial results for the full year 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 year ended December 31st, 2025, which were published earlier today, available within the financial report section on our investor website. I'm joined today by Valneva's CEO, Thomas Lingelbach, and our CFO, Peter Bühler, 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 additional information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the Autorité des marchés financiers, which are listed on our company website. Please note that today's presentation includes information provided as of today, March 18th, 2026, 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. 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, remained agile, and continued 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. This result reflects not only foreign exchange headwinds and supply reduction in third party 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 continuous disciplined cash management. Most importantly, 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 toward 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.

We will do so by leveraging our integrated business model. On the one hand side, you know, 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. 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. In Europe, it's probably gonna be the same order of magnitude also.

The reported and officially reported cases are a bit more than 130,000 annually. The important thing about Lyme disease is its severe clinical manifestation. 10%-30% of cases develop, you know, many different clinical manifestations, which can be categorized in three buckets, carditis, neuroborreliosis, and arthritis. Most importantly, 5%-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 one-to-one placebo against vaccine, two-to-one U.S. versus European sites, or to be precise, North American versus European sites. The primary endpoint is disease prevention after 3 + 1 doses, namely in season two, 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. As I said earlier, we hope that we're gonna get, of course, good data, and we have guided for data in the first half of this year. 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 really representing a compelling target population and a use case with a broad addressable population. We have tested in the study people above five years of age.

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. Of course, you know, there is a clearly attractive commercial dynamic. Prophylactics are always cheaper than therapy. A potential inclusion in some of the routine immunization schedules for high-risk areas would really be a perfect opportunity. With that, we see a unique and compelling opportunity that of course could be transformational for Valneva. Again, we are looking forward to the data being approved.

If we turn to IXCHIQ, you know that we are still investing in the further development of what we call VLA 1553, 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, in selected municipalities in Brazil. We covered the age range currently licensed by Anvisa in Brazil, namely 18-59 years of age. The objective is really to achieve a 20%-40% coverage within the target population. 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. This is a pragmatic, randomized, controlled effectiveness and safety study in adults and adolescents in endemic countries. Of course, we continue to work on ensuring greater access to address the unmet medical needs in endemic countries. We are in the process of expanding our network of manufacturing and distribution partners in low and middle income countries. 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 precautions. We are now focusing mainly on post-marketing effectiveness and global market access. Turning to shigellosis. 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. 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. Therefore, it has been identified as a priority vaccine by WHO. Valneva has worldwide commercial rights upon potential approval. 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. Probably more importantly, children in low and 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. Again, a very important milestone for the company and subject to data, we're gonna 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.

Thank you, Thomas, and good morning or good afternoon to all of you. Now moving on to the financial review, starting with details on our top line on slide 16. Total product sales reached EUR 157.9 million, in line with our guidance, and decreasing by -3.3% over 2024 or -1.3% at constant currency. The decrease in sales is primarily a result of the planned reduction in third-party sales and to a lesser extent, of adverse currency impact. As mentioned by Thomas at the beginning of the call, proprietary product sales, excluding currency effect, grew by +9% year-over-year. IXIARO sales reached EUR 98.4 million compared to EUR 94.1 million in 2024, representing a growth of 4.6% or 7.2% at constant currency.

The growth in IXIARO sales was driven by the travel segment. Dukoral sales were essentially flat at EUR 31.9 million compared to EUR 32.3 million in the previous year, a decline of -1.2%. At constant currency, Dukoral sales grew by +1.8% year-over-year. Growth in sales was impacted by a distributor change in Germany, a key indirect market. IXCHIQ sales reached EUR 8.4 million compared to EUR 3.7 million in the prior year. This includes the supply of 40,000 doses to the French island La Réunion in 2025. Finally, we reduced our third-party sales substantially year-over-year from EUR 33.2 million-EUR 19.2 million.

As discussed previously, this decrease was the result of planned termination of our existing distribution contracts for third-party products in order to focus on our proprietary products. Moving on to slide 17, looking at the P&L. Other revenues increased from EUR 6.3 million-EUR 16.8 million. The increase is driven by a EUR 10 million revenue recognition related to the license agreement with Pfizer. These ten million were previously included in refund liability on our balance sheet and represent the amount Valneva no longer expects to owe through future payments to Pfizer. Looking at our expense, cost of goods and services increased by EUR 8.6 million. Cost of goods in the fourth quarter were adversely impacted by a EUR 8.5 million inventory write-off, mainly related to Zika, following the termination of the contract with the Serum Institute of India.

We're talking here about an accounting write-down. The product is still available and could potentially be used for supply under future contracts in the endemic markets. Cost of goods also include approximately EUR 10.8 million of idle costs. IXIARO cost of goods remains stable versus prior year, while Dukoral gross margin deteriorated due to the failure of manufacturing batches in the fourth quarter. Research and development expenses increased from EUR 74.1 million in 2024 to EUR 85.3 million in 2025. This increase is in line with our guidance and is driven by higher spend on our phase II Shigella vaccine candidate. Additionally, we increased our R&D investment in our chikungunya vaccine as we are executing on our post-marketing obligations. Marketing and distribution expense amounted to EUR 37.4 million compared to EUR 62.4 million in 2024.

This significant decrease is a result of our reduced IXCHIQ spend compared to significant investments in prior launch years. G&A expenses decreased from EUR 42.8 million-EUR 37.3 million as a result of our continued initiatives to decrease administrative spend across the company. In 2024, Valneva sold a priority review voucher obtained with the approval of IXCHIQ in the United States, which net of expenses resulted in proceeds of EUR 90.8 million. Other income and expense decreased year-over-year by roughly 60% as a result of lower R&D tax credits and to a lesser extent, due to lower grant income in Scotland. In 2025, Valneva reports an operating loss of EUR 82.1 million compared with an operating profit of EUR 13.3 million.

The operating profit in 2024 was substantially driven by the non-recurring income statement of the sale of the priority review voucher. Finance expense includes the cost to refinance our debt with BioPharma Credit with a new five-year product loan with Pharmakon. Valneva's loss for the period reached EUR 115.2 million, while the Adjusted EBITDA is reported at EUR -51.4 million. Now moving on to the financial outlook. In 2026, we expect total product sales of EUR 145 million-EUR 160 million, and total revenues of EUR 155 million-EUR 170 million. The overall decrease versus 2025 is related to further planned reduction in third-party product sales, offsetting continued growth from our proprietary products.

We expect to progress in enhancing our R&D pipeline of differentiated vaccine candidates, and cash will continue to be a focus with an emphasis on reducing our operating cash burn. Subject to a successful Lyme disease vaccine approval and commercialization, we expect to become financially self-sustainable and potentially profitable. With that, I'll hand the call back to Thomas to look at our future value drivers.

Thank you so much, Peter. Yeah, well, let me turn to page 21 and talk a little bit about the future. Of course, you know, it will heavily depend on Lyme and what is the significance of the phase III results for Valneva. Well, positive results could be transformational, delivering substantial commercial milestone and royalty revenue to fund further pipeline development and value creation. It would also further validate Valneva's position as a leading vaccine biotech company, potentially becoming the fourth vaccine we have developed from bench to market. When we look at our key initiatives and what we really would like to do going forward, on the one hand side, we would like to build scale in our R&D pipeline.

This includes a potential strategic in-licensing to augment our in-house pipeline, while creating a risk-balanced portfolio of innovative specialty life cycle and high-value vaccine assets. We created Valneva 13 years ago, with an investment theme and focus on vector-borne diseases. We would like to expand now beyond vector-borne diseases, targeting assets based on defined criteria. We have a couple of quite interesting programs in preclinical. They are all, you know, well, some of them associated with AMR, but we have also a very interesting EBV program. All of that, we expect to accelerate and bring into clinical development subject to positive Lyme data. Of course, there is room to optimize our integrated operations to control our value chain by investing in enhancing our end-to-end capabilities and to structure our commercial model to optimize and maximize cash.

With that outlook, hopefully an outlook based on positive data, I would like to turn back to the operator to take your questions.

Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Once again, please press star one one to ask a question and wait for your name to be announced. To withdraw your question, please press star one one again. Thank you. We are now going to proceed with our first question. The question comes from the line of Maury Raycroft from Jefferies. Please ask your question.

Hi. Thanks for taking my questions. Looking forward to seeing the Lyme data soon. I know guidance is for first half 2026, but you recently said you expect the data soon. Do you still see potential for a readout by end of first quarter, or is it likely could it get pushed to the second quarter? And also, can you talk about your involvement in the data analysis? I'm wondering if you have access to the data room and can see real-time updates on the number of adjudicated Lyme cases. And do you see the split between the vaccine and placebo?

Maury, the sponsor for the phase III study is Pfizer. Pfizer are in total control with regards to the execution of the study, and we are, at this point, fully blinded. There is an official guidance from Pfizer with regards to the data readout in H1. Of course, we can't say anything different. We are hoping though, that the data will come around mid of H1, whenever this mid is. I would like to remind everyone that there is only one official guidance, and that's the one from Pfizer.

Got it. Understood. Can you comment on when the last time was that you spoke with Pfizer on the program, and what's the latest they're communicating to you based on status and timing?

We have a joint development structure. We have a governance as per contract, which includes you know, a couple of formalized bodies. I would say we have weekly interaction, frequent interaction, and so far, so good.

Got it. Okay. Maybe just last question, just if you can remind us what gives you confidence that VLA15 will be equally efficacious in serotypes 2 through 6 versus serotype 1? Wondering if you tested serotypes 2 through 6 in preclinical challenge models similar to the 2024 publication that you had.

Yes. First of all, this is an excellent question. In preclinical models, different preclinical models, some of which have been published, others not yet. We have done passive and active immunization, and tested against all serotypes. What we don't know is whether the immunological protection levels in humans will be identical across different serotypes. We have a lot of grounds to believe that, but of course, as you know, Maury, you know, outside of serotype one, which was shown through LYMErix and ImuLyme, there is no data in humans today that bridges immunological response with efficacy. Even for LYMErix, there was never a formal correlate of protection established.

There has been a publication that summarized a correlation factor of 0.8, so 80% correlation between immunological titers and protection. Of course, we hope to see the same. What gives us confidence is that in different models, different animal models, we have compared VLA15 against, I would call it an LYMErix biosimilar. And this has been shown in, you know, and published in different publications. As I said, not everything has been published. And we have seen across the board non-inferiority or superiority after, you know, three doses. And I think that that is mainly what gives us confidence in addition, of course, to the immunological profile that we have observed across many different clinical studies. By the end of the day, data will tell, and data will hopefully come soon, and then we will know.

Got it. All helpful. Thanks for taking my questions.

We are now going to proceed with our next question. The question comes from the line of Brandon Folkes from H.C. Wainwright. Please ask your question.

Hi. Thanks for taking my questions, and congratulations on all the progress. You know, maybe just staying on Lyme, how do you think about capital allocation going forward if Lyme is successful? That obviously changes your capital profile potentially quite significantly. How should we think about that aspect of the business?

Yeah. Brandon, hey, this is Peter. Well, look, I think it's important maybe to remind everyone that, you know, upon positive phase III data, we will not get any milestones under the program. The next milestones will be due upon first commercial sales. Essentially, it's first commercial sales in Europe and in the U.S., and it's a combined milestone of $143 million. But that's about, I would say, you know, probably a year and a half away from now at least. I mean, in terms of capital profiles over the short term, it's not really gonna change. Then I think, you know, we would certainly want to again accelerate and potentially augment our pipeline. And this will of course take time to do that, and we'll consider carefully how we do that.

Great. Thanks very much. Maybe just on Shigella, S4V2. When we see the phase II data later this year, sort of how should we think about the threshold there for Valneva moving forward with full development responsibility, or sort of perhaps other development paths on that program? Thank you.

Very good question, Brandon. I would say the thing that we like about this program is that it includes a controlled human infection model in adults. This means we will have adults challenged at least with one strain, namely Sonnei, and we will see what we call pilot efficacy. We will see whether people are protected and to which level they are protected, and more importantly, if there is an indication around what level of immunogenicity is required for them to be protected. This gives us, based on prior data, also a first hint into the children population, because there, of course, we don't challenge, but we will have also a good understanding about the immunological threshold.

Provided that we're gonna see pilot efficacy, provided that we're gonna see a decent level of, let's say, correlation also, it's not a statistical correlation, in between immunological titer, immunological response, and protection, we will progress this program further. If not, we have failed, and we have failed rather cheap. Which is the advantage of, you know, a program where you can really use a challenge model and see pilot efficacy, ahead of expensive phase III studies. Of course, we are planning for success. We are working on, you know, the development pathway going forward. As I mentioned earlier, we expect data from both studies mid this year. You know, we will of course inform the market about the next development steps.

Great. Thank you very much.

We are now going to proceed with our next question. The question comes from the line of Damien Choplain from Stifel. Please ask your question.

Yes, hello. Congrats on the good results, and thank you for taking my question. The first one is on ACIP recommendation. When do you expect to receive an ACIP recommendation for VLA15 if approved? And do you believe a broad recommendation is achievable for this vaccine? And if so, what would be the key criteria to get such recommendation? Thank you.

First of all, I think it's fair to say that currently to predict ACIP meetings, to predict ACIP outcomes, to predict ACIP dynamics, is probably a mission impossible, given the geopolitical environment in the United States. Having said that, we believe that Pfizer will progress fast post-approval into the ACIP process. ACIP, at least in the past, have reviewed a couple of major criteria. One, risk-benefit. This considers, of course, the safety profile that we're gonna see as part of the phase III study. On the other hand, the benefit of vaccination, which will be heavily driven also by the final efficacy we're gonna see in the different target groups. Probably also importantly, against serotype 1, which is the most prevalent serotype in the United States.

The other criteria is the health economic benefit. Well, we know that the costs of treating Lyme are very, very high and therefore, we believe that the health economic benefit will be very favorable for the vaccine. Now favorable for people living in high-risk areas. We know that there is a huge difference in Lyme incidence based on different geographies. We hope that we will get a broad recommendation for people living in high-risk areas and representing a high-risk population in those areas. You know, what this means in detail, hard to predict at this point in time. But we are very positive about a broad recommendation, provided data supports, of course.

Okay, thank you very much.

We are now going to proceed with our next question. The question comes from the line of Ami Fadia from Guggenheim. Please ask your question.

Great. Thanks so much for taking our question. Two if I could, one on back on Lyme and then one other topic. On the Lyme, appreciate everything you said around Pfizer running, you know, the trial here. Just curious if you know what actually would be in the top line press release, what should we expect in terms of what, you know, endpoint or information is planning to be disclosed. Anything you could share would be helpful just ahead of the release. The second one is on IXIARO. This is a question-specific question here just around the DoD contract, because that has been an important source of revenues for that vaccine in the past.

Do you have any information on sort of, you know, where that might stand in terms of contract for this year or looking forward?

Well, of course. Let me start with Lyme. We have previously communicated that we expect Pfizer to release top-line data. Well, top-line data, as you know, is something that is not clearly defined what it really means. What it means definitely is the primary endpoint. It is safety. Whether Pfizer will decide to announce more than that, this is at their discretion, and Valneva is currently not in any possession of information regarding what else may or may not be included in the top-line release. When it comes to DoD, yes, we are expecting a new contract. It is a vaccine broadly used in the Army in that we are under a sole supplier contract with the DoD. It's the only licensed JE vaccine in the United States. Yes, we can expect a new contract this year.

Okay. Is there any timing around that? Like when that might happen or no? Too early to tell.

I don't want to predict the timing because, again, we are talking government. We have intentionally not guided on any timeline associated with this.

Okay. All right. Thank you.

We are now going to proceed with our next question. The question's come from the line of Rajan Sharma from Goldman Sachs. Please ask your question.

Hi. Thanks for taking my question. Actually, first one for Peter. Could you maybe just help us understand the gross margin progression in 2026? Feels like there are a few moving parts in 2025. What are the pushes and pulls in 2026, and how much of that EUR 10 million or so in idle capacity costs are likely to reoccur in 2026? Also on the in-licensing and M&A that you mentioned as part of the strategy to rebuild the R&D pipeline, could you just discuss what that could look like in terms of size, structure, and if there are any specific areas of all segments of the market that you're likely to focus on, whether that's travel or otherwise?

Just one very quick follow-up on the DoD contract, and from the prior question, is that assumed within your revenue guidance for 2026? Thank you.

Where shall we start? Maybe we start off, I start off with the pipeline evolution, and then I let Peter talk about all the financial questions that you had. As I mentioned previously, we have also last year already initiated a process to look at external opportunities in the same way we are looking at internal co-opportunities. This resulted, for example, in the in-licensing of our Shigella vaccine candidate, and we will continue doing that. As I mentioned, we will definitely now go above and beyond vector transmitted diseases, and we will certainly go above and beyond travel. Because we believe, and again, planning for success, of course, that there are many, many potential vaccine preventable diseases that are currently not covered by the big vaccine players.

We have already given a focus area around enteric diseases in the context of AMR. We have also started with our EBV program to build around a potential herpes franchise. These are the key areas that we are currently contemplating. We have a dedicated team screening, scouting, evaluating, and we will decide, you know, on, you know, progressing internal or bringing in external opportunities in the coming months and years. Peter.

Yeah. On gross margin, Rajan, yes, there were a couple of things going on in 2025. I mean, I think the best way to look at it is by product. When we look at IXIARO, it is relatively stable versus 2024. What happened in 2025 is it was a bit adversely impacted by the change from the Manson building over to the Almeida facility, so a new manufacturing site in Scotland. And also related to that, because of this transfer, a bit of lower volume in manufacturing, which of course leads to a bit, you know, less effective overhead absorption. I think on Dukoral, we had a very good gross margin up until the end of Q3.

Then what we saw in Q4 is we had a couple of batch write-offs, which, you know, quickly had a quite a significant impact. This adversely impacted our gross margin in Dukoral. I think on IXIARO, you know, it's primarily, and that is of course a big hit on the cost of goods overall. It's the write-off we took on drug substance following the termination of the SII contract. As I said, those doses are still available. I mean, the product is good. It has quite a long shelf life.

If we manage to build a business in endemic market in Asia, those could still be written back basically and then sold. To your question on idle capacity. Yeah, I would say the EUR 10 million is probably a number that will, unless there is a major change in, you know, how we will make use of our manufacturing facilities, which we right now don't see, it's probably gonna stay a while, for a while, because we have over capacities in both Sweden and Scotland. Oh, yes. On military, what was your question on the DoD again? Sorry.

It's just whether that's in your guidance for 2026.

Absolutely. It's included in the guidance in 2026, you know, with the volume that we assume right now. They order, you know, they have a right to order additional doses within their 12-month period which they did, and it's then shipped after the 12 months, which is also why, you know, it's not because there's no new contract that there is no shipment. Shipments are continuing under the old one. As Thomas said, we expect the new contract and that will include a new guidance.

Thank you.

We are now going to proceed with our next question. The questions come from the line of Simon Scholes from First Berlin. Please ask your question.

Yes. Good afternoon. I've just got two questions. The first is on chikungunya, on the chikungunya vaccine and the status of VLA1553, which I think is the candidate for local manufacture in Brazil. Secondly, following the suspension of the SII licensing deal, I was wondering if you could just outline your next steps in Asia with regard to IXCHIQ.

Both excellent questions, I would say. Let me start with VLA1553. I mean, of course, the whole regulatory processes have slowed down the approval of VLA1553 by Anvisa. Now that we have concluded all the updates with the different regulatory authorities, including Anvisa, meaning, you know, sharpening the pencil on age ranges, sharpening the pencil on warnings and precautions, contraindications and all of that, there's no reason anymore for Anvisa to further slow down or wait for VLA1553 approval. Hence, we are expecting it quite soon. When it comes to our LMIC strategy in Asia, we decided to take control over the commercialization but also manufacturing of the product in Asia, given the growing medical needs outside of the Indian territory.

We are currently in the process of, you know, evaluating potential change of custody, evaluating potential partners, evaluating potential commercialization structures, and evaluating potential, you know, manufacturing strategies. We hope that we will be able to, you know, progress and announce that in the latter part of this year.

Okay, thanks very much. That's very helpful.

We are now going to proceed with our next question. The questions come from the line of Susanne van der Laan from VLK. Please ask your question.

Hi, it's Pauline on for Susanne. I have two questions regarding Lyme. For Lyme, could you clarify if the first cohort of participants in the phase III received a booster prior to the last tick season? Also, what about the second cohort of participants? We're also wondering at what point in time there will be booster data, and will the data be part of the filing? Thank you.

We have currently not included a so-called second booster or dose five because I'm assuming that you are referring to that. We will in a success case augment and provide an additional booster dose. Our current hypothesis is, as we presented, I think already a while ago at our R&D day in New York, that we will not be part of the initial licensure process, but for example, a supplemental BLA.

Thank you so much.

We have no further questions at this time, so I'll hand back to you for closing remarks.

Thank you very much for having joined us today. Been a pleasure. As I said, we are looking forward to our Lyme data. Again, fingers crossed. I think Valneva has great prospects, great opportunities. With that, stay tuned. Thank you so much.

This concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you.