Thank you. Hello, and thank you for joining us to discuss Valneva’s Full Year 2024 Results and Corporate Update. It’s my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the 12 months ended December 31, 2024, 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 CFO, Peter Bühler, who will provide an overview and update on our business as well as our key financial results for 2024. 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’ll 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 20, 2025, and Valneva undertakes no obligation to revise or update forward-looking statements, except as required by applicable securities laws. With that, it’s my pleasure to introduce Thomas to begin today’s presentation.

Thank you so much, Josh. Good day to everyone. Yes, Valneva had another successful year in 2024, thanks to no small part to the dedication and skill of our in-house teams and lawyer partners. When we look at the key highlights of the year, we achieved our targeted double-digit year-on-year sales growth with sales above €160 million, aligned with our 2024 guidance. We managed to have a very solid cash position at year-end, close to €170 million, with a significantly lower operating cash burn. And of course, all augmented by our successful placement of almost €60 million and the sale of our priority review voucher. And Peter is going to provide more details, of course, on all the financial performance indicators. We had a very strong regulatory execution with three additional IXCHIQ approvals and a very significant number of upcoming label extensions around IXCHIQ. And of course, we achieved one of our strategic objectives to augment our pipeline with a leading Phase 2 Shigella program. When we really look at what have we achieved and what are we expecting for 2025, this is all shown on Page 5 of the presentation. As I said, substantial clinical and regulatory progress as well as financial strength, really the headlines for 2024. When we look at 2025 ahead, we expect multiple data readouts. We expect product approvals, we expect label extensions. So when we look at this a little bit more in detail, so we expanded access to IXCHIQ. We have launches underway in Canada, Europe and the United Kingdom. And we entered into a new Asian partnership for key endemic markets. And especially the low medium-income countries are very important for this product. We reported further key clinical findings that supported the label extensions for IXCHIQ into adolescents. We have clearly, with…

Many thanks Peter for this comprehensive financial report for the full year 2024. Yes, let me remind you one more time, where we see really the growth drivers for 2025 and a little bit beyond 2025, it’s about Lyme. As we mentioned in this presentation, again, it is certainly a very, very important asset for the company and with an expected first readout by the end of the year. This is of course something that’s going to have an enormous impact on the future development and prospects of the company. We have our commercial business, which has delivered quite nicely over the past years and we see this really continuing. As Peter mentioned, the shift from lower third-party product sales primarily given that our commercialization partnerships we with BN will come to an end and more focus on our proprietary vaccines will substantially increase cost margin and hence the overall commercial business already this year is expected to be cash generative and will continue to provide cash that we can reinvest in R&D. And we have very nice R&D assets that we would like to progress and we expect some meaningful clinical data readouts this year, especially around Shigella and Zika. With that, I would like to hand back to the operator to take your questions.

[Operator Instructions] And now we’re going to take our first question and it comes from the line of Suzanne Van Voorthuizen from Van Lanschot Kempen. Your line is open. Please ask your question.

Hi, this is Suzanne from Kempen. Thanks for taking my question. Peter, can you elaborate a bit on the cash burn guidance? The debt is going down by over 50%. What are the main drivers behind this? And with that, can you also give some context to the R&D expenses going up for the coming year? And then another question for Thomas, more of a vaccine sentiment question. What risks or opportunities do you see stemming from RFK’s role now in the administration? We’ve seen some changes implemented at the CDC and the ACIP. But on the other hand, he also specifically mentioned his experience with Lyme. Can you elaborate on this please? Thank you. Peter Bühler: Yes. So I can start with the cash burn. Suzanne by the way thanks for the question. I will start with your question on cash. So I think there are various reasons why and you saw, of course, with the sales growth that will contribute. But also I think we will focus on cost containment in 2025. Also we will look at – we will work on our working capital clearly. But also we have a couple of initiatives. With the end of the COVID program, for instance, the collection of the R&D tax credits took a little longer. So we will put – in 2025, we expect to have the exceptional year where we will actually collect two years’ worth of R&D tax credits. So all these are reasons why we actually see – we’ll see a much lower cash burn. And of course, as Thomas mentioned also the commercial business returning to profitability will of course help our cash. Does it answer your question, Suzanne?

Yes, for sure. But maybe in R&D going up, can you also elaborate on that? Peter Bühler: Yes. So R&D going up, I mean a very significant contribution of course to that is the chikungunya Phase 4 trial. The mandatory trials that we need to do under the approval we have in the U.S. So that is really going to – base costs are really going to ramp up in 2025. And then of course also the rest of the pipeline that we’re accelerating and also our new Shigella program that is adding on to the R&D activities.

Good. So – and it is worth mentioning, Suzanne, that we will have a – the Phase 4 program will also be augmented by the Phase 3 initiation in pediatrics, which is also mandatory, the mandatory post licensure activity. All that peaks a little bit in the latter part of this year. This is why you see this relatively high R&D cost. But as Peter said, this is substantial offset through the CEPI grant as well as the R&D tax credit that Peter mentioned. On RFK, well, you gave us, of course, the question that we are receiving all the time. So first of all, our position is let’s not speculate. I think it is important that we monitor the situation quite carefully. Of course, all vaccine companies have been concerned about ACIP getting delayed. Necessary things that were supposed to be discussed at ACIP could not be discussed. So we need to really evaluate the impact. We need to see how this is going to go and develop further going forward. With regards to our existing vaccines on the market, these are mostly vaccines that are being paid out of pocket. They are currently not subject to, I would say articulated criticism around vaccination. They are targeting areas of very high unmet medical need. The health economical analysis for those vaccines are very favourable online, the situation is that the ACIP – the draft ACIP agenda had the formation of a Lyme working group on its agenda. So we hope that this is going to come very soon. And then our view, and you and I had this discussion before, my personal view is science will prevail. And so therefore, if there was an efficacious and safe vaccine against a devastating disease like Lyme disease, why should it not be used and given to people who can benefit most of it.

Got it. Thank you very much.

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

Hi guys. Thanks for taking my questions. Let me just kick off perhaps with some number questions. Can you just confirm whether you took any price rises on IXIARO and DUKORAL in the beginning of this year? I guess that’s question one. And then I guess the only other one on the numbers is – maybe two on the numbers. There was an intangible spend up to end of September about €10 million. And it seems to have gone down to €2.5 million in the cash. I was just wondering what happened in the last quarter to do that. And you mentioned about the R&D tax credits that you’re expecting. Could you just maybe quantify that for us? Thanks very much.

So I start with the first part of your question – Hi, Samir, by the way. So we had no material price increases in 2024 for any of our products. So you have almost a like for like volume comparison. I’m sure that was your question.

Actually, Thomas, it was about 2025 rather than 2020 – at the beginning of the year you’ve taken it…

No, it is 2025, sorry, Samir. This is what I meant.

Yes. Okay.

So basically nothing at this point in time. And then, Peter, to your – to the other part of the question? Peter Bühler: Yes. So your question on intangible, Samir. So that was basically an upfront payment we had made to – for the in-licensing of the Shigella program. And as our partner, LimmaTech is executing some of the R&D work, we then brought some of the – there was – basically the cost that they are contributing to the Phase 2 right now, we actually moved out of the intangibles. So that’s why this...

Okay. Makes sense. Yes. Okay. Makes sense. And then just the one on the R&D tax credits, Peter, that you mentioned. What sort of quantity is that if you maybe can tell us that? Peter Bühler: Well, yes, we do not give guidance on the R&D tax credit. But when you look at our 2024 financial statements, you will see that out of the 20 million that you see in other income, about half of it is R&D tax credit and the other half is grant. So that gives you a rough idea of what the tax credit was that we collected in 2024. But as I said, for 2025, we have not given the detailed guidance.

Okay. And then just maybe if I could sneak one final one in. Just on the application for approval of IXCHIQ in Brazil. Is there any update as to when we might see that? Thanks very much.

Yes. So on Brazil, we are – that we had anticipated the approval in Brazil in the first quarter. The – we have been seeing some delays on the process. And basically, we have not received any further list of questions, so that – which means the review process is very close to its end. I mean our partner, Butantan are pushing hard on ANVISA right now. All the other steps have been successfully completed like pre-approval inspections and so on and so forth. That the approval, also it is a delay right now. The approval is not yet on the critical path. We need this approval to start the pilot vaccination program that we anticipate and will combine then with the Phase 4 requirements which is necessary to start in the rainy season, so which means we have a bit of buffer. And therefore, we hope that we’re going to get the approval very soon.

Right. Thanks very much.

You’re welcome.

Thank you. Now we’re going to take our next question. Just give us a moment. And the question comes from the line of Rajan Sharma from Goldman Sachs. Your line is open. Please ask the question.

Hi. Thanks for taking my questions. Just relating to IXCHIQ and maybe just following up on that policy question from earlier. Do you think the postponement of the February ACIP meeting could actually be beneficial for you near term given there was supposed to be a vote on your competitors’ chikungunya vaccine as well, I believe? And then secondly, just again, following up on IXCHIQ. Could you just talk to the market dynamics that you’re seeing so far? I appreciate it’s still relatively early, but in terms of the revenues that you have generated and the traction that the vaccines got, where is that coming from based on what you’re able to see? Thank you.

Let me start with the latter part because there’s not a lot I can say to the first part of your question. But let’s talk a little bit about IXCHIQ dynamic. So first of all, we are absolutely convinced that the IXCHIQ [ph] market will develop over time. We discussed it in the past. We were initially a bit too optimistic with regards to the ramp-up, but we are absolutely convinced that this product will lead to a good commercial opportunity. Why is that? Because chikungunya is a severe disease. And the more we see in terms of outbreaks, the more we see in terms of clinical manifestations, the more we get to the point of saying that and seeing that chikungunya is not just a flu-like symptom disease, but it comes with pretty severe health impairment, some of them pretty long-lasting. And what we see right now is that there is more and more disease awareness. So there is all the investments that we have been doing, that our competitors have been doing are really driving the general understanding around chikungunya. On top of that, we see outbreaks. I mean, you have all noticed that there is a pretty severe outbreak on La Réunion right now with more than 2,000 cases in a single week. We have published health economic analysis in a very renowned journal, which also shows that the health economical situation for chikungunya vaccination is very favorable. So all in all, to tell you that there is clearly a growing awareness. The growing awareness comes with growing demand. And we see, of course, substantial prospects in the low medium-income countries. Both of our partners have signaled quite substantial initial demand for their respective launch years, which in reality will be next year, but we will supply already drug substance to them this year. In the United States, we are still waiting for the MMWR. And you heard Suzanne’s question up at the beginning. I mean, there were many things that were supposed to be discussed at ACIP. We have been – this delay of MMWR does not help access to the retail channel. So all of that will hopefully be resolved soon and then drive uptake. The initial situation that we see in Europe. And thus far, we have launched in France. We have launched in Canada. We are going to launch in UK. The initial signs look good. And everyone can – based on our guidance and based on what we have said about the decline of third-party products and the increase of IXIARO and DUKORAL, everyone can make the math of what we have assumed in terms of IXCHIQ sales this year. And then from there, we have to see how it’s further going to develop. I think this is all I can say at this point in time about the IXCHIQ dynamic and the market dynamic around chikungunya.

Okay. Thank you.

Thank you. Now we’re going to take our next question. Just give us a moment. And the question comes from the line of Oscar Haffen Lamm from Bryan, Garnier. Your line is open. Please ask your question.

Hi team. Oscar here from BG. I believe most of my questions have been taken in, but maybe on Zika. I was curious what your view was on the evolution of the epidemiology and ultimately, how this would affect the potential continuation of the program into Phase 2? And then what – when would you expect the Phase 2 to start and your estimated cost on that one? Thank you.

You’re talking about Shigella Phase 2?

The Zika Phase 2.

The Zika Phase 2. No, on the – so basically, on the Zika, at this moment in time, we are with Zika in the Phase 1, as you know, we have a first data readout expected by the end of the year. This will then followed by an antibody persistence period. We want to really understand antibody persistence since this has been an issue in the past. And basically, then we will take it from there and talk to the authorities about the clinical development pathway. And I would say the earliest we could start a Phase 2 study if we decided to progress into Phase 2 would probably be at the end of 2026, early 2027. So this is the current time horizon.

Got it. Thank you.

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

Great. Thanks for hosting the call and taking my question. So a couple, I apologize if I missed this, but on the IXCHIQ, just the – you’ve talked previously about your midterm guidance and kind of being relooked at. I’m wondering just kind of given all the dynamics, when you think it’s an appropriate time for us to expect that to be announced? And then second, on Lyme, I know Pfizer, as you mentioned here, Pfizer aims to submit the application next year, assuming positive data. I’m just trying to get clarity on the exact timing for the data readout because Pfizer actually doesn’t list it as sort of a key event on their catalyst page for this year. I know you guys think it’s coming. So I’m just trying to clarify do you expect the data this – like end of this year? Or do you think the actual data readout itself may go into next year? And just kind of how we should think about that? Thank you. Peter Bühler: So, well, yes, thanks for the questions. So on IXCHIQ, yes, we did give indeed the midterm guidance in the past. We did say earlier on that we might have to revise that. And indeed, we think we have to revise it as you saw that the ramp-up of sales was lower than we had anticipated. We still believe in the potential of the product. And we still think that the guidance we gave in terms of level of sales is achievable, but it will certainly take a little longer. And as we said, we need a few more data points. The 2025 started, right, we just have two months now where we have more data points. and we’re launching a new territory. So I think we still need a bit of time to really confirm by when we will get to the critical number. But – and this is also why we have not decided to give a new midterm guidance at this stage. We will – we may, in the future, come back and give more indication, but it just requires a little more time. Thomas, on the timing of the data readout for Lyme?

Yes. So I mentioned at the beginning of the call and throughout the presentation that we are expecting first data readout at the end of 2025. This will be followed by further analysis, further secondary endpoint readout in the earlier part of 2026. We have previously in our joint press releases Pfizer said that we’re going to submit the regulatory submissions in 2026. And that we anticipate to ideally bring the product into the market in time so that people can benefit from it for the 2028 tick season.

Okay. All right. Thank you.

You’re more than welcome.

Thank you. [Operator Instructions] And now we’re going to take our next question. And the question comes from the line of Maury Raycroft from Jefferies. Your line is open. Please ask your question.

Hi, congrats on the progress and thanks for taking my questions. I was just going to – I’ll ask one on chikungunya. So with Bavarian Nordic recently approved, maybe just talk about that and how you plan to leverage your first-mover advantage and accelerate the launch in 2025? I’m also wondering if you still expect that the CDC will publish the MMWR this year and around July and how we should think about that as well?

So basically – so first of all, we are very careful right now in predicting any time lines when it comes to MMWR, CDC, ACIP processes because, I mean, realities have shown that we have big unknowns here. So we have to see really how this is going to evolve. But yes, our internal planning is still assuming that we’re going to get MMWR this year. When it comes to Bavarian, of course, I mean, what I said in the past, we’re not going to talk about competitor products and their dynamic and what it will do or not do. I mean the point is I believe that there is a strong share of voice because I mentioned a couple of times that for chikungunya, disease awareness is key. And I think the more we see their really work around further increasing the awareness of the disease, the better it is.

Understood. That makes sense. And also, I just wanted to see if there’s any additional perspective you can share related to the vaccinated subjects that were hospitalized after getting IXCHIQ and what your expectations or some scenarios that could come out of the discussion at the upcoming ACIP meeting?

Yes. So I think what we are seeing here is a normal process. Cases were reported under the VAERS system. The causality [ph] of those cases with the vaccination is being assessed. We have provided all the necessary information to ACIP, [indiscernible] CDC as well as FDA. We don’t want to speculate and we don’t want to say anything right now about how they conclude on the causality. We have, of course, our own opinion around that, but let the process reveal. So – and I think we take it from there whatever the outcome is going to be.

Makes sense. Okay. Thanks for taking my questions.

You’re more than welcome, Maury.

Thank you. [Operator Instructions] There are no further questions for today. I would now like to hand the conference over to the management team for any closing remarks.

Yes. Thanks a lot for your attendance today. Thanks a lot for your great questions as usual. We are looking ahead with confidence. We are looking ahead into a great 2025, knowing, of course, that 2025 is a transitional year for the company as we are moving towards Lyme data, which will be very critical for the further strategic development of the company. And as such, we are looking forward to some very interesting further readouts this year, as mentioned. And again, thank you so much for your attention. Thanks so much for your interest and support of the company and wishing you all the best for the rest of the day. Thank you.