Good day, and thank you for standing by. Welcome to the Valneva Q1 2022 financial results conference call. At this time, all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Thomas Lingelbach, CEO of Valneva. Please go ahead.
Good day, and welcome to our quarter one financial results and corporate update call. Pleasure to be with you again today. The quarter one has again been marked by excellent progress on our clinical programs. We have been able to report further positive phase two results for our Lyme vaccine candidates, including quite exciting first pediatric data, first ever in the world of Lyme vaccine development. On COVID-19, our program, VLA2001, we received MHRA conditional marketing authorization in April, NHRA emergency use authorization, including first vaccination in Bahrain. 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 recorded final positive pivotal phase three data and we initiated the pre-submission process with the U.S. FDA, and again, I'm gonna go more into the details of those programs. With regards to our top line and cash position, we have recorded total revenues of EUR 21.8 million in Q 1 2022. We had actually first sale from first COVID shipment into Bahrain, and we see some positive signals in the travel vaccine market, and again, Peter will detail it a bit further. Our cash position remains strong at EUR 311.3 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. We have gone through a number of phase one, phase two trials to determine final dose and final schedule. With that, we have been able to determine also dose and schedule for the phase three, which we expect to commence in the third quarter this year. The vaccine is based on a multivalent recombinant subunit approach, covering the six different serotypes prevalent in the northern hemisphere, so that the vaccine is designed to protect against Lyme disease on both sides of the Atlantic.
The vaccine, as we reported many, many times in the past, is based on a validated and proven mode of action. Specifically on the news regarding pediatric data or first pediatric data, the Phase two study that we conducted, study VLA15-221, included 625 participants aged 5- 65 years of age. We saw both in the adult as well as in the under eighteen year, which we call pediatric, participants, a very strong immunogenicity profile. We reported the 18+ data already in February and now the 5- 17 in April. In the participants 5- 17-year-olds, of course, as expected, the vaccine was found to be more immunogenic as compared to adults.
We even saw that we could already obtain a good level of immunogenicity after two doses of the final dose schedule that we have determined, maybe a three-dose schedule. Which will certainly have a value in a later post initial licensure setting and when it comes to recommendations and uptake. The phase three study is still planned to start in the third quarter this year. Please keep in mind we are talking about a three-dose priming, month zero, two, and six. In order to have our study cohort fully vaccinated for the tick season 2023, we've got to start in the latter part this year.
This is a study that will include participants all the way from five years on and apply, as I said, the 3-dose primary vaccination schedule. The clinical readout, you know, if achieved after one season already, is projected by the end of 2023 or a sixth season later should it not be feasible earlier. The phase restart will trigger a $25 million milestone payment by Pfizer to Valneva. Moving on to chikungunya. You also are well aware of the fact that our chikungunya vaccine candidate, called VLA1553, is the most clinically advanced chikungunya vaccine program worldwide. It is the only program on the planet today that has shown positive pivotal phase three data, final positive pivotal phase three data.
We have complemented that also with the lot to lot data. At this point in time we are still in the follow-up period, so this means we have reported top-line data at this point only. We have also initiated the adolescent phase three trial. This is a post-marketing activity, so we will seek initial licensure in everyone 18 years and above and then, you know, supplement and extend the label later, post initial licensure. This development is being conducted in Brazil. You know that we have a grant with CEPI and a partnership with Instituto Butantan for two reasons.
Number one, to help conducting those studies, which are of course conducted under IND and, but also to make the product available to low medium income countries at a certain point in time. On the program, we have literally all, you know, regulatory benefits that you can think of at this point in time, Breakthrough Therapy, Fast Track, EMA PRIME designation and of course, as we have expressed many times, the first company to achieve BLA approval will potentially be eligible for priority review voucher, and here Valneva is certainly in the pole position.
By way of strategic reminder, we see this vaccine providing an excellent fit both within our existing commercial and manufacturing infrastructure in a market that we see clearly exceeding EUR half a billion annually over time, of course. You know, what is the outlook? We have initiated the pre-submission activities with the FDA. I mentioned already that we completed the final phase three data readout, basically confirming what we saw already earlier, namely an excellent seroresponse rate close to 100%. We saw positive lot to lot consistency data. We wait for the follow-up. You know, antibody persistence study is ongoing.
We expect a subset of respective participants to be followed for up to five years because we hope, of course, that our vaccine will protect for a long time after a single shot. I mentioned the adolescent phase three trial that we already initiated. With all that, we are really gearing up towards FDA submission process, BLA submission process, in the second half of this year. VLA2001, our COVID vaccine candidate, it is still the only inactivated whole virus COVID-19 program in the clinic in Europe, as we said at the beginning, partially already approved.
It builds on our IXIARO manufacturing technology that combines this conventional approach with a modern toll-like agonist, an adjuvant CpG 1018, which is supposed to drive the immune response stronger toward Th1. We received, as mentioned, MHRA conditional marketing authorization and, of course, the emergency use authorization from the Bahraini NHRA. As I mentioned, Peter mentioned, our ongoing EMA rolling review still ongoing. I think we have reported in the past that at this moment in time we have one major supply contract with the European Commission up to 60 million doses, of which a bit less than half of that is supposed to still be delivered this year, subject to product approval, of course. Some of the deliveries that we have done already to Bahrain.
The basis for licensure is the immunocomparability. We showed superiority against AstraZeneca's product and a significantly more favorable tolerability profile. We also reported very positive top-line homologous booster data, showed in vitro neutralization against Omicron and Delta and other variants of concern. We are in the process of extending our label gradually, which is expected post the initial licensure of the vaccine. Being shown on page 11 of the presentation, the initial licensure primary immunization 18-55. In the UK, we got 18-50. Of course, as soon as we have data available from our elderly study that was conducted in New Zealand, including booster follow-up, we expect to extend the label towards 50 or 55+.
We reported last night that we initiated a heterologous booster study. We understand that this is, of course, important that our vaccine can also use in people that got primed before, be it through mRNA, multiple vaccinations or and/or natural infection. This is the study that will, in the proper setting, evaluate that. We are very glad that we have finally been able to initiate the study. Not so easy these days in the environment of COVID. All the what we would call the adult adolescent activities, so 2-70 years of age, those activities have all been initiated, or at least the first part has been initiated, second part is about to be initiated.
This will of course take longer to get respective data in children because we had also now to conduct to move outside of Europe in order to to get the necessary sample size and the necessary participants to the respective studies. Yeah, with that general business update, I would like to hand over to Peter, who's gonna provide you with the financial report.
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 EUR 21.8 million, down EUR 1.4 million or 5.9% versus the Q1 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 prior year. IXIARO sales are significantly down versus prior year, and this is purely driven by lower sales to U.S. military.
This decrease was anticipated according to the planned shipment schedule. As the footnote of this slide indicates, IXIARO six-pack sales outside of U.S. 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 EUR 2.5 million compared to EUR 100,000 one year ago, or a total of EUR 2.4 million for the full year of 2021. The increase in sales of IXIARO outside the U.S. 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 EUR 5.6 million.
The main drivers for this increase are higher sales of the Bavarian Nordic products, Encepur and Rabipur, across primarily U.K., France and Austria, where we started to distribute these products at the end of fiscal year 2020. Finally, as already mentioned, we are able to report the first sales of our COVID-19 vaccine with a shipment to the Kingdom of Bahrain. Moving on to slide 15 and looking at the P&L. We already covered product sales. Other revenues decreased by 20% versus prior year to reach EUR 5.6 million. This line primarily includes revenues from the Pfizer R&D collaboration for Lyme, as well as manufacturing services provided to third parties. Looking at our costs, you can see that each expense line is significantly down versus the prior year.
Overall, this decrease is to a large extent attributed to a release of provisions for share-based compensation and the related social security cost. The cost of phantom share programs for certain employees, as well as the cost of social security on our equity plans, depend on the development of our Valneva share price. In total, in Q1 of 2022, we recognized an income of EUR 11.7 million that was offset against the different expense lines. This compares to a cost of EUR 4.8 million in Q1 of 2021, so a year-over-year comparison, we have a positive delta of EUR 16.5 million. Excluding that special effect, our Q1 cost would be broadly in line with prior year.
Financial expense and income tax is reported EUR 7.6 million compared to an income of EUR 3.4 million in Q1 of 2021. The difference is due to foreign exchange gains reported in the prior year, while in this year's first quarter, we had to report a foreign exchange loss. The total loss for the period of EUR 26 million is EUR 1.7 million lower than in the prior year, while EBITDA reached EUR 13.3 million compared to EUR 28.3 million in prior year. Here again, the main driver of the difference relates to the provision release related to share-based compensation. Slide 16 provides a waterfall reconciliation of the operating loss of Q1, 2021 to Q1 of 2022. This illustration shows clearly that the variance is by and large due to the release of provisions related to the share plans.
Slide 17 shows our P&L for Q1 with the separation of the COVID business versus the rest of the group. Looking at our COVID business, cost of goods exceed sales, which is mainly driven by ramp-up costs as we start commercial manufacturing. We invested EUR 21 million in R&D for COVID, following an R&D investment of EUR 114 million for the full year of 2021. As you can see, we continue to invest significantly into the development of our COVID vaccine. The R&D spend in the first quarter includes clinical trial costs, as well as costs related to tech transfer to our manufacturing partner. Again, all cost lines are positively impacted by the previously mentioned income derived from the share pay-based compensation, which essentially explains the positive R&D expense for our business excluding COVID.
Finally, before moving to the guidance, I would like to comment on our share cash situation. As reported in this morning's press release, we closed the quarter with a total cash of EUR 311 million compared to EUR 236 million one year ago and EUR 347 million at the end of 2021. With this very strong cash position, we have the necessary financial resource to execute on our plans in 2022. The reported cash position at the end of March does, of course, not yet include the increased financing arrangement with Deerfield and OrbiMed. With this, let's move on to guidance on slide 19. We maintain our full year total revenue guidance in the range of EUR 430 million-EUR 590 million.
The distribution of total revenues by category may, however, differ from the figures announced in February, given the uncertainties on the timing of product deliveries. This concludes the financial section of this call, and I would like to hand back to Thomas for the upcoming catalysts.
Thank you so much, Peter. Yeah, on page 21 of the presentation, you see a summary of the upcoming catalysts and our expected news flow in 2022. Very few changes compared to when we spoke last. On Lyme, 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 two, we expect, of course, the phase three trial initiation in the third quarter this year. On chikungunya, we expect the final lot-to-lot phase three data following the follow-up period, still this quarter. As I mentioned, the BLA submission in the second half of this year. On COVID, we of course are still waiting for the regulatory approval, specifically, for the EMA.
You know, we have reported earlier that we have now responded again against the respective list of questions received. We are still at this point in time confident that what we have submitted at this point in time may be deemed sufficient to grant a Conditional Marketing Authorization or positive CHMP opinion this quarter. Yeah, we may see additional regulatory approvals, of course, in other jurisdictions and territories, and we are working on further supply and potential purchase agreements. We are working on the additional clinical studies, the one that we announced yesterday evening, for example, also the others that I showed you on the slide that are designed to support the label extension post initial licensure.
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's 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. As a reminder, if you wish to ask a question, please press star one on your telephone keypad and wait for your name to be announced. If you wish to cancel your request, please press the hash key. Once again, please press star one if you wish to ask a question. 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 it's obviously positive to see the first order come through from Bahrain. How many shipments are left to fulfill the Bahrain order, and is that all expected this year? I guess that's question one. Just a clarification on the guidance. I just wanted to make sure that your R&D previously guided at EUR 160 million-EUR 200 million, is that range still applicable? The final question is just on the chikungunya trial in adolescents that was started in January. I was just wondering when is that due to report, and is that using an immunological endpoint? Thanks very much.
Hi, Samir, Thomas speaking. Yes, we are expecting a second shipment to Bahrain later this year. On chikungunya, as you know, we have agreed with the FDA a surrogate marker. This means that the correlate of protection in a way is has been derived through passive transfer and non-human primates. There is immunological threshold that determines in a way what we called in the old days zero protection, and which of course is at this point in time now basically called zero response in the new regulatory language. It is basically the indicator for efficacy. Yes, an immunological endpoint on the execution timeline and the readout.
You have, of course, perfectly noted that we have not given a guidance right now on the execution timeline of the study. 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 question.
Yeah. Thank you, Thomas. Yeah, on the guidance on R&D, yes, we do maintain the guidance we gave early this year of EUR 262 million, but we maintain that one.
That'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 thirtieth 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 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 respective member states, with the EC team of course, who then, you know, contact and work with the respective member states.
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 its clear benefit, namely, A, convincing people to still get vaccinated, and B, having a potential additional booster solution or repeat priming solution for the forthcoming fall and winter season, is still given. That's why we remain positive about the dialogue that we have ongoing.
Got it. Okay. 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. 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, you know, 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 a positive CHMP opinion in April based on what we had understood was requested. 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. 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 gonna 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. We will not, you know, make or provide any expectation 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.
Yeah.
Thank you. Next question comes from the line of Max Herrmann from Stifel. Please go ahead.
Great. 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. Yeah, basically a couple of things. 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. This means that the alignment on the timelines on what will be submitted by when and how is super critical, and this is exactly where we are at this point in time. This is what we are doing. It's not on the what, I would say. It's more how.
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 Langan on for Seamus. 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 2023, 2022-2023? As a second question, on the heterologous boost study, can you talk about the choice of study design, namely the single arm versus or without a comparator, and what geographies do you believe the study combined with your other booster studies can support approval in? Thanks.
Yeah. Let me start probably with the second part of your question first, if I may. 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 infected, but who are from an immunological standpoint, in parentheses, ready to be boosted. This means you need a respective time point, because if not, you get again, you know, very difficult to interpret results like the ones that we saw a year ago in the COV-BOOST study, for example. We had to use such design.
At the same time, we wanted to mimic also what we see in real life right now, namely that some people got, you know, vaccinated and then, you know, naturally infected. If they are, you know, for example, if this happened six months ago, you know, this would be another setting where a booster could make sense. There is, for us, not really an added value of an active comparator in the booster because we do not want to show, you know, the booster ability against an active comparator. We want to be, and this for a very simple reason, because, you know, who knows what is a good enough booster answer.
What we want to see is that we create an anamnestic 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 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 input. Got it. Thank you.
Thank you. As a reminder, if you wish to ask a question, please press star one. Next question comes to the line from Jean-Jacques Le Fur from Bryan, Garnier & Co. Please go ahead.
Good morning. Thank you for taking my questions, too, actually. The first one is regarding the potential label for your COVID vaccine. Without any mention of any efficacy percentage, like we saw with the mRNA vaccine, 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 first question. The second one is, when could we expect the next shipments for U.S. Military, next IXIARO shipment, sorry, for U.S. Military, if any, for the rest of the year? Thank you.
Let me start with the first question, and then I'm gonna 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. 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 shown in the label? I don't think so. I have. I'm 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 during a certain period of time in a specific trial has any, you know, 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. This is how we will position our vaccine. Franck, do you have any answer with regards to when the next shipment to the U.S. military is due? Yes. It is planned for in Q3.
Okay. Thank you, Franck.
Thank you. Next question.
Thank you. Crystal clear answers as usual. Thank you very much.
You're more than welcome. Pleasure.
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. It was just on following the MHRA approval of VLA2001. Has that changed sort of negotiations with other potential vaccine purchasers since the approval?
It has, of course, I would say, stimulated more conversations and we are advancing more conversations following this first approval by a Western regulatory agency. Of course, as we discussed already last time, we will also use this now as the backbone for the WHO pre-qualification process, which again will then trigger discussions with additional parties outside of Europe.
Just as a follow-up, do you have a timing on the WHO approval or inclusion?
We are working, Max. 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.
Thank you very much.
That's to inform the markets immediately. Yeah.
Thank you. Next question comes from the line of Sebastian Bray from Kempen & Co. 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 the CHMP asked actually. The PR mentioned that the EMA did not consider the submission sufficient. Was that 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.
Mm-hmm. Mm-hmm. Very good question, Sebastian. So basically, as we said in the past, we have pre-agreed a pivotal study, phase three study for COVID, and we have pre-agreed the endpoints with both regulatory agencies and the MHRA as well as EMA. Since we have delivered on all endpoints in the study, which means we match 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 immunobridging. Otherwise, MHRA could not have approved that vaccine either. Mm-hmm.
Basically, the nature of the request that we have, as we have tried to indicate in our regulatory update, is. I use an example that, and of course, we cannot disclose all the level of details, but we use an example. We have in many additional analysis and subsets on immunological data, we have not in all areas and across all the data sets measured both binding as well as neutralizing antibodies, for example. Also both have shown to correlate highly. You know, of course, one of the things where, you know, for example, the EMA wants to have both, whereas others, we're okay with just one.
We have a few other, you know, things where we are now seeing an additional request, for example, on CMC. As I said earlier, we have responded to all of the questions received. We responded to it in, you know, six working days, and we hope that with what we have submitted on time is good enough for the EMA to finally assess this product candidate, hopefully in a positive way.
With regard to the booster, you are addressing a very good question and, it's one of the questions that we are receiving, you know, on almost a permanent basis now after we filed the announcement last night. Yes, there are potential differences. Let me remind everyone about the COV-BOOST study. The COV-BOOST study was a study in the UK conducted at the moment in time where people had been primed around three months before they got the booster. Which means, and this was.
The COV-BOOST study had to be conducted at the time because it was designed to inform the JCVI in the UK about their decision which vaccine candidate or which vaccine to use for the winter 2021-2022. People had still pretty high titers at the point they were boosted. The second was, we had an elderly cohort, the average age was about 70 years. We have the setting that we are now seeing in our study is a more real-life setting. It is a setting where people will be immunologically in need of a booster. This means after six months, six months ago, either last vaccination or natural infection. Hence, immunologically, as I said, in need of a booster.
B, we would go across the entire age spectrum in order to also see potential differences in age. These are the two major differences between the COV-BOOST study and what we are seeing today. As I said, one about the immunological booster need, the age, and in reality a third one, namely that we include also the natural infection which never was included in the COV-BOOST study. 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.
No further remarks. Thanks a lot. Again, thanks a lot for following us so closely. We look forward 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 the VLA2001. With that, again, many thanks and have a good remainder of the day. Bye-bye.
That does conclude our conference for today. Thank you for participating. You may all disconnect.