Good day, and welcome to our quarter one Financial Results and Corporate Update Call. Pleasure to be with you again today. Yeah. So basically, the quarter one has again been marked by excellent progress on our clinical programs. We have been able to report further positive Phase II results for our Lyme vaccine candidates, including quite exciting first pediatric data, first ever in the world of Lyme vaccine development. And on COVID-19, our program VLA2001, we received MHRA conditional marketing authorization in April. MHRA Emergency use authorization, including first vaccination in Bahrain. And the EMA rolling review process is still ongoing. We had hoped that to conclude in a similar way that we were able to conclude MHRA, but the process is still ongoing. On chikungunya, we reported final positive pivotal Phase III data, and we initiated the presubmission process with the US FDA, and I'm going to go more into the details of this program. With regards to our topline and cash position, we have recorded total revenues of EUR21.8 million in quarter one 2022. We had actually first sales from first COVID shipments into Bahrain and we see some positive signals in the travel vaccine market. And again, Peter will detail a little bit further. And our cash position remains strong at EUR311.3 million at the end of March. With that, I would like to go into the details of the program. On our Lyme vaccine, by way of reminder, as you know, we are working on a multivalent Lyme vaccine candidate. It is the only Lyme disease program in advanced clinical development today worldwide, FDA fast track designation granted, exclusive worldwide partnership with Pfizer and we have gone through a number of Phase I, Phase II trials to determine final dose and final schedule. And with that,…

Thank you, Thomas, and good morning or good afternoon to everyone. Let's go straight into the financial review of our first quarter of fiscal year 2022. Our total revenues reached EUR21.8 million, down EUR1.4 million or 5.9% versus the first quarter of 2021, while our total product sales are broadly in line with prior year. As previously communicated, we shipped the first doses of VLA2001, our whole virus inactivated vaccine against COVID-19 to the Kingdom of Bahrain in March. This accounted for almost 25% of our product sales in the first quarter. Moving on to slide 14, where you will see that the composition of our product sales has changed versus high yield. IXIARO sales are significantly down versus prior year, and this is purely driven by lower sales to US military. This decrease was anticipated according to the planned shipment schedule. As the footnote of the slide indicates, IXIARO/JESPECT sales outside of US military performed much better than one year ago and almost quadrupled. For DUKORAL, we can also report a significant recovery of our business with sales reaching EUR2.5 million compared to EUR100,000 one year ago or a total of EUR2.4 million for the full year of 2021. The increase in sales of IXIARO outside the US military and DUKORAL is a result of a recovering travel market, which presumably also includes some inventory replenishment in the distribution chain. Third-party products more than doubled versus prior year, reaching sales of EUR5.6 million. The main drivers for this increase are higher sales of the Bavarian Nordic products, Encepur and Rabipur, across primarily UK, France, and Austria, where we started to distribute these products at the end of fiscal year 2020. And finally, as already mentioned, we are able to report the first sale of our COVID-19 vaccine with the…

Thank you so much, Peter. Yes. On page 21 of the presentation, you see a summary of the upcoming catalysts and our expected news flow in 2022. So very few changes compared to when we spoke last. Online, of course, the most important one is now that we have delivered on all our, I would say, clinical endpoints and expectations in the Phase II. We expect, of course, the Phase III trial initiation in the third quarter this year. On chikungunya, we expect the final lot-to-lot Phase III data following the follow-up period till this quarter. And then as I mentioned, the BLA submission in the second half of this year. On COVID, we of course, are still waiting for the regulatory approvals, specifically for the EMA. We have reported earlier that we have now responded again against the respective list of questions received. So we are still, at this point in time, confident that what we have submitted at this point in time, maybe being sufficient to grant conditional marketing authorization or positive CHMP opinion this quarter. And yes, we may see additional regulatory approvals, of course, in other jurisdictions and territories and we are working on further supply and potential purchase agreement. And we are working on the additional clinical studies. The one that we announced yesterday evening, for example, but also the others that I showed you on the slide that are designed to support the label extension post initial licensure. So a lot going on, a lot that we expect for this year. Many things that get us all excited. Of course, it is a lot of execution challenge around that, but we feel that there is significant news flow and upside coming in the rest of the year. With that, I would like to hand back to the operator to take your questions.

Thank you. We will now begin the question-and-answer session. [Operator instructions] And the first question comes from the line of Samir Devani from Rx Securities. Please go ahead.

Hi, everyone. Thanks for taking my questions. I think I've got three. I guess, obviously, positive to see the first order come through from Bahrain, the shipments are left to fulfill the Bahrain order? Is that all expected this year? I guess that's question one. And then just a clarification on the guidance, I just wanted to make sure that your R&D previously guided at EUR160 million to EUR200 million. Is that range still applicable? And then the final question is just on the chikungunya trial in adolescents that was started in January. So, I was just wondering when is that due to report? And is that using an immunological endpoint? Thanks very much.

Hi, Samir. Thomas speaking. So yes, we are expecting a second shipment to Bahrain later this year. Then on chik, as you know, we have agreed with the FDA a surrogate marker. So this means that the correlate of protection in a way has been derived through passive transfer in nonhuman primates, so there is a logical threshold that determine in a way what we called in the old day zero protection and which, of course, is at this point in time now basically called zero response in the new regulatory language, but it is basically the indicator for efficacy. So yes, an immunological endpoint on the execution timeline and the readout, you have, of course, perfectly noted that we have not given guidance right now on the execution timeline of the study. And quite frankly speaking, we do not feel comfortable to do that at this point in time. As I said, we are not doing it directly ourselves. We are working through a partner, and we are at the beginning of the whole trial setting. We have not yet enough visibility to really say how long it will take. But we hope that we will get this visibility very soon, and then we will, of course, update our guidance accordingly. Let me hand over to Peter to take the financial questions.

Yes. Thank you, Thomas. Yeah. On the guidance on R&D, yes, we do maintain the guidance we gave early this year, it would be EUR160 million to EUR200 million, we maintain that one.

It's great. Thanks very much.

Thank you. Next question is from the line of Maury Raycroft from Jefferies. Please go ahead.

Hi. Good morning and thanks for taking my questions. I'm wondering if you can talk about the current timelines outlined in the COVID EC supply agreement, including the prior April 30 deadline and how these timelines are affected by current dialogue with EMA?

Yeah. Excellent question, Maury, of course, as expected. I mean, as you all know, we have filed in our respective documentation, including URD and 20-F that there -- the European Commission and its member states have certain rights to terminate and/or reduce orders if we are not able to achieve respective approval by a given date. Now with the unexpected delays that we are experiencing in the EMA approval process, we have, of course, initiated dialogue with the member states with the team, of course, we then contact and work with the respective member states. We -- this is a process that is ongoing. And of course, we do hope that the member states largely concur with us that there is still a potential need for such a vaccine. And that even if the vaccine came a bit later than originally expected, its medical need is still there, and it's a clear benefit, namely, A, convincing people to still get vaccinated, and B, having a potential additional booster solution or repeat driving solution for the forthcoming fall and winter season is still given. And that's why we remain positive about the dialogue that we have ongoing.

Got it. Okay. So just to clarify, I guess, is there an extension to the deadline then? Or nothing has been finalized at this point?

It's not finalized at this point, but discussions are ongoing.

Okay. Okay. And then, I also just wanted to ask for the CHMP recommendation. Is it possible to put any more of a finer point on when that could happen in potentially May versus June, I guess, any other thoughts on that?

Well, I mean, Maury, it's a very difficult situation for a company and for Valneva in this particular situation to provide any guidance and to predict any regulatory timelines and processes. We had originally hoped to see positive CHMP opinion in April, based on the -- on what we had understood was requested. The -- we got another round of list of questions. We responded to the list of questions to our best knowledge, and to the best extent we could do. And so with that, we are, of course, triggering another process. We have right now in our last press release where we provided the regulatory update. We have said that we are expecting a positive CHMP opinion in the second quarter. We have currently not given any projection whether it's going to be May or June. In reality, we expect probably that it does not make a big difference in terms of the use of the vaccine and all the processes that we have to undergo now with the EC. So we will not make or provide any expectations at this point in time when this is going to be.

Okay. Okay. That makes sense. Thanks for taking my questions. I'll hop back in the queue.

Thank you. Next question comes from the line of Max Herrmann from Stifel. Please go ahead.

Hi. Thanks very much for taking my questions. Actually, most have been asked. But one question just on VLA1553. Could you give us a little bit of detail what the pre-submission areas of discussion are with the FDA or give us a bit more clarity in terms of what that process entails? Thank you

Hi, Max. Good to hear your voice. So yes, basically, a couple of things. So first of all, it is the agreement of the submission procedure, so rolling versus non-rolling. The second point is the timeline and the cadence of submission of the different modules. You are certainly aware of the fact that the regulatory authorities are super busy with COVID-related activities, which still are being prioritized. So this means that the alignment on the timelines on what will be submitted by when is -- and how is supercritical and this is exactly where we are at this point in time. And this is what we are doing. It's not on the what, I would say, it's more how.

So how much clarity do you have in terms of your ability to file in the second half of this year for chikungunya?

We have a very high degree of visibility. Otherwise, we would not give this guidance.

Okay. Great. Thank you very much.

You're welcome.

Thank you. Next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.

Hi. This is Evan Wang on for Seamus. I wanted to follow up on the EC conversations. Do you remain confident in the purchase of the -- full purchase of the 24 million doses in 2022 and 60 million - and up to 60 million in '23 -- '22 to '23? And then as a second question, on the heterologous booster study, can you talk about the choice of study design, namely the single arm versus without a comparator? And what geographies do you believe the study combined with your other booster studies can support approval on? Thanks.

Yes. So let me start probably with the second part of your question first, if I may. So yes, so first of all, it is not easy to conduct at this point in time booster studies that allow a meaningful readout because by the end of the day, you need to find people who have been vaccinated or naturally impacted, but who are from an immunological standpoint in [indiscernible] is ready to be boosted. So this means you need a respective time point, because if not, you get again very difficult to interpret results like the ones that we saw a year ago in the COV-Boost study, for example. And so, we had to use such a design. At the same time, we wanted to mimic also what we see in real life right now, namely that some people got vaccinated and then naturally impacted. And if they are -- for example, if this happened six months ago, this would be another setting where a booster could make sense. And then there is -- for us, there is not really an added value of an active comparator in the booster because we do not want to show the booster ability against the active comparator, we want to be -- and this for a very simple reason because who knows what is a good enough booster? And so what we want to see is that we create an immune response in a heterologous setting and that we are respectively setting up an immune response level that is certainly above the level that we achieved after priming with our vaccine, which showed to be a level good enough in terms of both protection as well as safety. To your first question, at this point in time we have no reason to not to be confident on anything that we have negotiated with the EC in the past. As I mentioned earlier to one of your questions, the dialogue has been initiated. We are in the midst of this process. We have, at this point in time, no further insight.

Got it. Thank you.

Thank you. [Operator Instructions] Next question comes from the line from Jean-Jacques Le Fur from Bryan Garnier. Please go ahead.

Good morning. Thank you for taking my questions. Two actually. The first one is regarding the potential label for your COVID vaccine. Without any mention of any efficacy percentage like we saw with an RNA, I think, for example, the 70%, 90% and so on. How you think the label could look like for your vaccine? And do you think it could be harder to promote your vaccine without this simple figure? This is my -- or not difficult, sorry. This is my first question. And the second one is, when could we expect the next shipments for US military next IXIARO shipments, sorry, for US military, if any, for the rest of the year? Thank you.

So let me start with the first question, and then I'm going to hand over to Franck for the second question because I'm not sure whether I've got the exact timing of the shipment for the next military shipment in my mind. So well, I mean, do you I'm assuming that you are getting an annual flu shot. Have you ever looked at the percentage of effectiveness on the flu shot that is showed in the label, I don't think so. I have -- I am more than 30 years in the vaccine business. I don't think that a percentage of, let's say, effectiveness against a non-circulating strain that was achieved by -- during a certain period of time in a specific trial has any promotional effect. I think by the end of the day, regulatory authorities have to assess whether a product is efficacious and whether a product is safe, and this is what they conclude and that's all what they conclude. And this is how we will position our vaccine. Franck, do you have any answer with regards to when the next shipment, the US military is due?

Yes. So it is planned for end Q3.

Okay. Thank you, Franck.

Thank you. Crystal clear answers as usual. Thank you very much.

You're more than welcome.

Thank you. Next question comes from the line of Max Herrmann from Stifel. Please go ahead.

Great. Thanks very much for taking a follow-up question. Just on -- following the MHRA approval of VLA2001, has that changed sort of negotiations with other potential vaccine purchases since the approval?

It has, of course, I would say, stimulated more conversations, and we are advancing more conversations following this approval by -- this first approval by Western regulatory agency. And of course, as we discussed already last time, we have also -- we will also use this now as the backbone for the WHO prequalification process, so which, again, will then trigger discussions with additional parties out of Europe.

And just as a follow-up, do you have a timing on the WHO approval?

We have not yet -- this is the reason why we have not provided guidance yet. As you know, we will only provide guidance when we have clarity on the timeline. At this point in time, we don't have yet, but we will have soon I think from the market immediately.

Thank you very much.

Thank you. Next question comes from the line of Sebastiaan van der Schoot from Kempen. Please go ahead.

Hi, guys. Thank you for taking my questions. Two from our side. The first one is on the type of questions that we're seeing at PR actually. The PR mentioned that the EMA did not consider the submission sufficient, wasn't based on the efficacy data set? Or is that something else or CMC? And then regarding the new trial, the heterologous boosting trial, how does that exactly differ from the trial that you did with the UK, the UK boost trial? Is there anything different in the regimen? And what will be the primary endpoint in that study? Thank you.

Very good question, Sebastiaan. So basically, as we said in the past, we have pre-agreed a pivotal study Phase III for COVID and we have cleared the endpoints with both regulatory agencies and the MHRA as well as EMA. Since we have delivered on all endpoints on -- in the study, so which means we met all endpoints in the study. And this means the primary endpoint, the secondary and the tertiary endpoint, it means automatically that there's no questioning about the pivotal character and the readout of the study and its eligibility to prove effectiveness by way of immuno comparability. The nature of the -- and otherwise, MHRA could not have approved that vaccine either. So basically, the nature of the request that we have -- as we have tried to indicate in our regulatory update is, and I use an example that -- and of course, we cannot disclose all the level of details. But we use an example. So we have in many additional analysis and subsets on immunological data, we have not in all areas and all the data sets measure both binding as well as neutralizing antibodies, for example, yes? And also, both have shown to correlate highly, and the -- of course, one of the things where, for example, wants to have both, whereas others were okay with just one. And then we have a few other things where we are now seeing additional request, for example, on P&C. But as I said earlier, we have responded to all of the questions received. We responded to it in six working days, and we hope that with what we have submitted at this point in time, is good enough for the EMA to finally assess this product candidate, hopefully, a positive way. With regards to…

Okay. Great. Thank you very much.

Thank you. There are no more questions at this time. I would like to hand back over to the speakers for final remarks.

For further remarks, thanks a lot. Again, thanks a lot for following us so closely. We look to continuing our close dialogues here and we'll update you as soon as we can, especially on the process and progress in connection with VLA2001. With that, again, many thanks, and have a good remainder of the day. Bye-bye.