Good day, and thank you for standing by. Welcome to Valneva's Full Year 2025 Results and Business Update Conference Call and Webcast. [Operator Instructions] Please note that today's conference is being recorded. I would now like to turn the conference over to your speaker, Josh Drumm, VP of Investor 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 31, 2025, 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 Buhler, who'll 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, March 18, 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, remain agile and continue 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. These results reflect not only foreign exchange headwinds and the planned reduction in third 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 continues disciplined cash management. Most importantly so, 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 towards 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, and we will do so by leveraging our integrated business model. On the one hand side, commercial, manufacturing…

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 minus 3.3% over 2024 or minus 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 effects, grew by plus 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 minus 1.2%. At constant currency, DUKORAL sales grew by plus 1.8% year-over-year. Growth in sales was impacted by 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 French Island La Réunion in 2025. Finally, we reduced our third-party sales substantially year-over-year from EUR 33.2 million to 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 to EUR 16.8 million. The increase is driven by a EUR 10 million revenue recognition related to the Lyme agreement with Pfizer. These EUR 10 million were previously included in refund…

Thank you so much, Peter. Yes. Well, let me turn to Page 21 and talk a little bit about the future. Of course, 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 to become -- potentially becoming the first 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 kind of -- or 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. And 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.

[Operator Instructions] We are now going to proceed with our first question. The question come from the line of Maury Raycroft from Jefferies.

Looking forward to seeing the Lyme data soon. I know guidance is for first half '26, 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?

So Maury, the responder for the Phase III study is Pfizer. Pfizer, I don't 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. And of course, we can't say anything different. We are hoping so that the data will come around mid of H1, whenever this [indiscernible] But we -- I would like to remind everyone that there is only one official guidance, and that's the one from Pfizer.

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

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

Got it. Okay. And 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. So first of all, this is an excellent question. So 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 the different serotypes. We have a lot of grounds to believe that. But of course, as you know, Maury, outside of serotype 1, which was shown through LYMErix and ImuLyme, there is no data in humans today that bridges immunological response with efficacy. And even for LYMErix, there was never a formal correlate of protection established, but there has been a publication that summarized a correlation factor of 0.8, so 80% correlation in between immunological titers and protection. And 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, a LYMErix biosimilar. And this has been shown and published in different publications, as I said, not everything has been published. And we have seen across the border non-inferiority or superiority after three doses. And I think 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 that we will...

We are now going to proceed with our next question, and the questions come from the line of Brandon Folkes from H.C. Wainwright.

Congratulations on all the progress. 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. So how should we think about that aspect of the business?

Yes, Brandon, this is Peter. Well, look, I think it's important maybe to remind everyone that 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, probably 1.5 years away from now at least. So I mean, in terms of capital profile in the short term, it's not really going to change. And then I think we would certainly want to again accelerate and potentially augment our pipeline. And this will, of course, take time to do that, and we will consider carefully how we do that.

Great. And then 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 parts on that program?

Very good question, Brandon. So I would say the thing that we like about this program is that it includes a controlled human [ infection ] model in adults. So this means we will have adults challenged at least with one strain, namely [indiscernible] and we will see what we call pilot efficacy. So 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 to 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 going to see pilot efficacy, provided that we're going to 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 a program where you can really use a challenge model and see pilot efficacy ahead of extensive Phase III studies. Of course, we are planning for success. We are working on the development pathway going forward. And as I mentioned earlier, we expect data from both studies mid this year. And then we will, of course, inform the market about the next development.

We are now going to proceed with our next question, and the questions come from the line of Damien Choplain from Stifel.

Congrats on the good results. The first one is on the ACIP recommendation. So 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?

So first of all, I think it's fair to say that currently to predict ACIP meetings, to predict ACIP outcome, 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. And 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 going to see as part of the Phase III study. And on the other hand, the benefit of vaccination, which will be heavily driven also by the final efficacy that we're going to see in the different target groups and 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 cost of treating Lyme are very, very high. And therefore, we believe that the health economic benefit will be very favorable for that vaccine. Now favorable for people living in high-risk areas. So we are -- we know that there is a huge difference in Lyme incidents based on different geographies. And 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. What this means in detail, hard to predict at this point in time. But we are very positive about a broad recommendation provided data support, of course.

We are now going to proceed with our next question, and the question comes from the line of Vamil Divan from Guggenheim.

So two, if I could. One on back on Lyme and then one other topic. So on the Lyme, I appreciate everything you said around Pfizer running 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 endpoints or information is planning to be disclosed. So anything you could share would be helpful just ahead of -- release. And then the second one is on IXIARO. And this was a 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 where that might stand in terms of contract for this year or looking forward?

Well, of course, let me start with Lyme. So 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 their discretion. And Valneva is currently not in any possession of information regarding what else may or may not be included in the top Lyme release. When it comes to DoD, yes, we are expecting a new contract. It is a vaccine broadly used in the army that we are under a sole supplier contract with the DoD. It's the only licensed -- vaccine in the United States. And yes, we can expect a new contract this year.

Okay. Is there any timing around that like when that might happen or not, too early to tell?

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

We are now going to proceed with our next question, and the questions come from Rajan Sharma from Goldman Sachs.

Actually, first one for Peter. Could you maybe just help us understand the gross margin progression in 2026? It feels like there are a few moving parts in 2025. What are the pushes and pulls in '26? And how much of that EUR 10 million or so in idle capacity costs are likely to reoccur in 2026? Then 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 or segments of the market that you're likely to focus on, whether that's travel or otherwise? And then just one very quick follow-up on the DoD contract from the prior question. Is that assumed within your revenue guidance for 2026?

So where shall we start? Maybe we start off -- I start off with the pipeline evolution, and then I'll 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 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 vascularly transmitted diseases. And we will certainly go above and beyond travel. Because we believe, 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. And we have already given a focus area around enteric diseases in the context of AMR. But we have also started with our EBV program to build around a potential herpes franchise. And these are the key areas that we are currently contemplating. And again, we have a dedicated team, screening, scouting, evaluating. And we will decide on progressing internal or bringing in external opportunities in the coming months and years. Peter?

Yes. So on gross margin, Rajan, yes, there are a couple of things going on in 2025. We now when we -- I mean, I think the best way to look at it is by product. So when we look at IXIARO, it is relatively stable versus 2024. What happened in '25 is it was a bit adversely impacted by the change from the Manson facility over to the Almeda facility, so our 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 less effective overhead absorption. I think on DUKORAL, we had a very good gross margin up until the end of Q3. And then what we saw in Q4 is we had a couple of batch write-offs, which quickly has a quite a significant impact, and this adversely impacted our gross margin in DUKORAL. And I think on the [indiscernible] always primarily and that is, of course, a big hit on the cost of goods overall. Is the write-off we took on drug substance following the termination of the SII contract. And as I said, those doses are still available. I mean the product is good. It has quite a long shelf life. And if the -- if we manage to build a business in endemic market in Asia, those doses could still be written back basically and then sold. To your question on idle capacity, yes, I would say the EUR 10 million is probably a number that will -- unless there is a major change in how we make usage of our manufacturing facilities, which we right now don't see. It's probably going to stay for a while because we have overcapacities in both Sweden and Scotland. Yes. So military, what was your question on the DoD again and Russia, sorry?

It's just the guidance for 2026.

Absolutely. So it's included in the guidance in 2026 with the volume that we assume right now. So they order -- they have a right to order additional doses within the 12-month period, which they did and it's then shipped after 12 months, which is also why it's not because there's no new contract that there is no shipments. So shipments are continuing under the old one. And then as Thomas said, we expect the new contract and that all included in the guidance.

We are now going to proceed with our next question, and the questions come from the line of Simon Scholes from First Berlin.

I've just got two questions. The first is on chikungunya -- on the chikungunya vaccine and the status of 1555, which I think is the candidate for the local manufacturer in Brazil. And then 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.

So both excellent questions, I would say. So let me start with 1555. I mean, of course, the whole regulatory processes have slowed down the approval of 1555 by Anvisa. Now that we have concluded all the updates with the different regulatory authorities, including Anvisa, meaning sharpening the pencil on age ranges, sharpening the pencil on warnings and precussions, contraindications and all of that. There's no reason anymore for Anvisa to further slow down or wait for 1555 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 need outside of the Indian territory. And we are currently in the process of evaluating potential change of custody, evaluating potential partners, evaluating potential commercialization structures and evaluating potential manufacturing strategies. And we hope that we will be able to progress and announce that in the latter part of this year.

We are now going to proceed with our next question, and the questions come from the line of Suzanne van Voorthuizen from VLK.

It's [indiscernible] on for Suzanne. 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 peak season? And also what about the second cohort of participants? And we're also wondering at what point in time there will be booster data? And will the data be part of the filing?

So we have currently not included a so-called second booster or dose 5 because I'm assuming that you are referring to that, but we will in a success case augment and provide an additional booster dose. And 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 VLA.

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. It's been a pleasure. And as I said, we are looking forward to our Lyme data. So again, fingers crossed. I think Valneva has great prospects, great opportunities. And 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.