Valneva SE

Good day and thank you for standing by. Boniva presents its first quarter 2026 financial resorts. 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 this conference is being recorded. I would now like to hand the conference over to your speaker today, Joshua Drum, Vice President, Global Investor Relations. Please go ahead.

Hello, and thank you for joining us to discuss Valnevo's financial results for the first quarter to 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 Buehler, 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 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 13, 2026, and Belneva 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. Yeah, our first quarter was certainly dominated by the LIME 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 30 million euros. 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 facings, 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 Lime, 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 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 to 15% and aims to result in a significant 25 to 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 myths 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 we have observed fewer than anticipated Lyme disease cases that were agreed 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 authority. 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. Also, we all acknowledge that those reported numbers are probably heavily underreported. Clinically, Lyme comes with different clinical manifestations. Ten to 30% of the individuals develop either catiasis, neuroborreliosis, or arthritis. and some, namely 5% to 10%, 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 individuals in the study aged five years and above. And 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 regard. There is, of course, a strong strategic fit with Pfizer's existing business and franchise. And 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 egg-stick 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 it's progressing quite nicely. We have a very significant pilot vaccination campaign ongoing in Brazil. The vaccine is being given to adults 18 to 59 years of age. And the objective is to reach a 20 to 40% coverage within this target population across various municipalities in Brazil. We have already vaccinated more than 30,000 people to date. And 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, major achievement in the endeavor that is supported by CIPI and for which we are grateful on advancing this vaccine and advancing access into countries and for countries who can really benefit from it. A few words on Shigella and our Shigellosis program. It is certainly one of the most advanced, if not the most advanced, tetravalent vaccine candidates against Shigellosis. We are targeting the four most common pathogenic Shigella bacteria. And previously, our partner, Lima Tech, 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 pyrodificacy study, so-called controlled human infection model for both. We are expecting the first readouts or the readouts over the summer. And then, 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 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. So overall, a lot going on on our key R&D and business activities. And with that, I would like to hand over to Peter to provide us with the financial report.

Thank you, Thomas. Yes, so looking at the financial report for the first quarter of fiscal year 2026, product sales reached 30.5 million euros compared to 48.6 million euros one year ago. Ixiaro sales were 20.2 million euros compared to 27.5 million euros 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 US Department of Defense. Deliveries in the first quarter of 2026 have continued under the current contract signed in January 2025. Doucoural sales reached 8.6 million euros compared to 12.3 million euros 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, Ducoral 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 traveler's market. This change took effect from January 1 and included the transfer of residual inventories, which in the case of Ducoral were sufficient to satisfy the demand for the current first quarter. We expect new product deliveries to resume in the second quarter of 2026. XGIC sales reached 1.6 million euros compared to 3 million euros 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 as from travel sales in the United States. Third-party products were reduced to 100,000 euros compared to 5.8 million euros in last year's first quarter, and this decline reflects the intentional wind-down of third-party product distribution to increase the focus on our proprietary products. Now moving on to the income statement. We reported total revenues of 30.9 million euros versus 49.2 million euros in the first three months of 2025. Other revenues remained largely unchanged year over year. Cost of goods and services were 26.2 million euros versus 21.3 million euros in the prior year. The increased cost of goods, despite lower sales, were a result of several factors. Idle cost increased compared to one year ago, following the completion of the manufacturing transfer to the new Almeda facility. The cost related to failed batches and inventory provisions, in addition to onerous contracts related to Ixtric, 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, including Ixchic, was 45.2%, compared to 62.7% for the three months ended March 31st, 2025, or approximately 50% for the full year of 2025. Ixchiara's gross margin reached 50.8% compared to 72.6% in the first quarter of 2025, and the decline was driven by a higher manufacturing cost following the transfer of production to the Alameda 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 Xero gross margin reached 59.6%. The gross margin of XGIC 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 5 million euros. 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 remains stable year over year at 15.2 million euros, mainly representing investments into Ixtric and Shigella, as well as our preclinical EBV projects. Marketing and distribution expenses in the first quarter reached €7 million, compared to €10.4 million in the prior year. The decrease is mainly related to lower spend on XGIC, in particular in the United States. General and administrative costs decreased to €8.2 million, compared to €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 23.7 million euros driven by lower sales and gross margin. Net finance and income tax expense is reported at 8.4 million euros compared to 3.3 million euros in the prior year. The increased expense is driven by a foreign exchange loss of 3 million euros compared to foreign exchange gain of 3.7 million euros in the prior year. With this, the loss of the first quarter of fiscal year 2026 reached 32.1 million euros compared to 9.2 million euros 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 105 million euros compared to 110 million euros at the end of the prior fiscal year. In the first quarter of 2025, we continue 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. Now 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 135 to 150 million euros for the fiscal year 2026, and total revenues to 145 to 160 million euros. 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 and 15% and expect an overall reduction in our operating expense of about 25 to 35% compared to the level of 2025. This concludes the final section of this call, and I would like to hand back to Thomas.

Thank you so much, Peter. You have 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 LIME success, and we plan for a successful outcome of the LIME process that will be run by Pfizer with the respective regulatory authorities. And if successful, it would offer for 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 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, And you have seen that some of our preclinical activities, especially EBV and also the enteric disease focus point in already in this direction. And 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.

Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again.

One moment for our first question.

And this question comes from the line of Murray Rykoft from Jefferies. Please go ahead.

Hi. Thanks for taking my questions. I'll ask a couple on the LIME program. I know there's a degree of uncertainty there, but I'm 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. And 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.

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

Understood. Okay. And 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 have back in the queue.

Thank you. Our next question comes from the line of Susanne van Hoogtweesen from Kempen.

Please go ahead. Hi, this is Romy on for Susanne. Thanks for taking our questions. The first is on Exario growth dynamics. So I was wondering if the decline we saw for Q1 of this year was solely driven by phasing with the USDOD, or was there also contributions from the private travel markets? And then a follow-up there, for the full year 26 guidance adjustment, is this primarily based on your thinking of the general travel dynamics expected this year? Thank you.

So let me take the question first, and then possibly Peter can complement. So I think, as we said during our report, it's a combination of various factors. And certainly, the major contributing factor, as reported by Peter, has to do with facing of supplies to the DOD, our single largest customer for Xearo. You know, the supply schedule and the phasing is different year over year, and it's very hard to predict the exact supply schedule, and that makes always this quarter-to-quarter comparisons really difficult. There is, however, Also a contributing point around reduced travel. And Peter presented very clearly that this is the root cause and the major cause for why we have been taking a prudent stand and revised the guidance down by 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. And this is also supported by airline data. And we see this trend emerging. Um, so the, um, and that's, I think all we can say with regards to the dynamic of Xero and Peter, please jump in if you want to add anything.

Yeah, I think the only, the only other thing to add is, and to, to a lesser extent than, than, than the shipments to US military, there is this impact on, on the indirect markets with the, with the shifting of distributor, where we see a slight impact, not as much as on Ducoral, but we see a little impact also on,

on onyx era but this is more just you know technically the switch over from from to a new partner right thank you thank you we will now take our next question and this question comes from the line of family divine from guggenheim partners please go ahead

Great thanks for taking my questions and maybe a couple more on the on the line front and appreciate may not be able to answer all these fully right now, but what I'm curious when we would actually when you think the full data will be released for us to review it in totality. Second, I'm wondering, are there other examples you can point us to a vaccine 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 the still getting through? And then 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. And does that in any ways have an impact on what you think in terms of the commercial opportunity for this vaccine, sort of the interest in the amount of events that are happening in the community? Is there any change to your views based on what you saw in terms of how many people were acquiring the disease during the trial?

Thank you. Yeah, so let me start from the back to the front here a little bit. So, yeah, I mean, as we reported in the press release, the total end, meaning the total number of reported and adjudicated cases was certainly lower than anticipated, which resulted in this widespread confidence interval lower and upper. We don't necessarily see this with regards to what is happening in the high-risk areas of Lyme, and this is certainly something that we will need to look into, 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 two different channels, including social media, analyst reports, where people focused on 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, but 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. And 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 optimal way. To your question about where and when will the data in totality be presented, Pfizer stated that they will present the full data set 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 Chaplain from Stifel. Please go ahead.

Yes. Hello. Thank you for taking my questions. I have a couple questions on the restructuring plan. So 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&E? And the last one, when do you anticipate achieving full payback from the program? Thank you very much.

Yeah, thanks for the questions, Damien. So in terms of timing, you know, as we, you know, a lot of the redundancy we're looking at, when we look at people costs, a lot of the redundancy we're looking at are in Austria, and there's a clear legal process. So actually, this will continue for a while. And then, of course, similar to other European countries, there will be notice periods. So the full payback will certainly only be next year on that. We initiated the process now with the Austrian authorities. And I think information to staff will occur approximately in a month from now. I think when it comes to external spend, this is actually initiated now. and we do expect a significant savings for the remainder of 2026 and then of course carried over into 2027. And between R&D and SG&A, sorry, most of the savings we expect in R&D as opposed to, if you compare to 2025, right, in sales and marketing, it's going to be more or less cosmetic in line with kind of the adjustments we did to the top line. And then in G&A, it's in a way a continuation of savings we've already seen in 2025 versus prior year. And we will add on some savings, but it's not going to be as substantial as in R&D, of course.

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. And so to lay with the point 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? And then I had a couple of financial questions which I can follow up with.

So 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 at different time points as compared to the market.

Okay, got it. Thank you. And then a couple on the financials. So Peter, I think, well, you guided to normalize 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 10 million of idle capacity costs and you've reported 5 million already in first quarter of 26. I've I think at four-year results, you mentioned that idle capacity costs in 26 would be similar to 2025. So is that still the case? And then 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 implies around a 12% decline versus 25. In Q1 26, you've seen a 26% decline. And I think third-party products will trend down. And it sounds like the travel market slowdown that you mentioned was not fully realized in Q1. So, 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 a lot, Sean. So on gross margin, normalized gross margin, so I, you know, and it's it's of course it's 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 um in terms of idle capacity it is a bit higher than last year uh it's not the full five million so we said the five million is is uh idle plus some unallocated costs so most of the five million is is 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 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, 130 to 150. Where we will land in this range, we can't say, of course. That's why we gave the range. But right now, we feel comfortable that it's appropriate. 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... especially in the Middle East, gets worse and the travel market gets affected, you know, we cannot exclude it will have an impact. But as 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. And this question comes from the line of Brandon Foulkes from HC Wainwright. Please go ahead.

Hi, thanks for taking my questions. Just changing gears here a little bit and focusing on the Shigella Phase 2 readout. 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? And then maybe just looking a bit further out on this, if you were to commercialize that product, would you be selling to the same core points as Ducarol? Can you just talk about the commercials? 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.

Yeah, so first of all, the thing that we really like about this program is that through the controlled human infection model, that is currently run through at John Hopkins, we will get pilot efficacy. We are challenging people with one strain, namely the Shigella-Sona strain. And 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. And ideally, a first indication about the immunological threshold that needs to be reached in order to see protection. On the children's side, We hope to see that, you know, we see a solid immunogenicity profile, good seroresponse rates, and that we have a first idea about the schedule and whether this two-dose schedule in children will be sufficient or not. So this is what we expect to see from those studies. And then we're going to take it's hard to say, to predict right now what the outcome is going to be. But the good thing is you have a huge de-risking in case of positive data. And 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 those schedules 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 pacing or pace. associated with it as compared to previous hypothesis, but strategically and focus-wise, we don't see a real difference. Now, coming back to your question around commercialization, which is a very good one, Shigella and Shigellosis has two 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. you know, in the ideal world, one would target step-by-step a multivalent vaccine covering more than just triglycerides. So combination vaccines that could potentially also include, you know, ETAC, cholera, and other components. But as a second step, And I think those combination vaccines in the enteric disease field would certainly represent a huge commercial opportunity. And 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 Shigella vaccine in travelers. Again, 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. And in order to present the traveler's diarrhea vaccine, you will need to add additional antigens above and beyond even, you know, cholera and ETEC. But 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 going to focus on combination right away. It's something that we are exploring. And it will be part of our review in connection with the future development plan for Shigella. And 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 prod covering E-Tech vaccine, Helidate, for example, covering both LT as well as ST. And, 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 questions.

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

Thank you. As a reminder, to ask a question, you will need to press star 1 and 1 on your telephone. We are now going to take our next question. And this question comes from the line of Simon Scholes from First Berlin Equinity Research. Please go ahead.

Yes, hello. I've just got one question. You wrote in the 2025-20F that you'd received a letter from the FDA preventing you from using the Almeda facility to produce Ixiaro for distribution in the US. 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.

So, first of all, yes, you're right. We received 483 as part of the pre-approval inspection and the complete response letter with regards to the pre-approval supplement of Almeda as an alternative site for Ixiaro manufacturing. We have, however, received approvals for the new manufacturing site from all the other regulatory bodies. Now, we were smart enough to file Almeda as an additional manufacturing site, and the existing facility is still active. And I think this is important to note. And we are releasing product out of the previous facility or the existing facility called Menson into the US market as we speak. And of course, we are working with the FDA to address their concerns articulated in the 483. and we'll resubmit the pre-approval supplement process, you know, as soon as we can.

Okay, so you don't expect any impact from temporary inability to use Almeda on Xero 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 Dingerbach for closing remarks.

Thank you so much for your attendance today, great questions, and for following Valneva. And 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.