Valneva SE
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Good day, and thank you for standing by. Welcome to the Valneva Reports Q1 2021 Financial Results and Business update conference call. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your first speaker today, Mr. Thomas Lingelbach. Please go ahead. .
Very good day. Welcome to our quarter 1 results and business update call. So yes, so the quarter 1, 2021 has been marked by excellent progress on our clinical programs. We have been able to initiate an additional Phase II study on Lyme to accelerate the pediatric development within our partnership with Pfizer. We transitioned our COVID vaccine candidate into Phase III and started the Phase III trial for the vaccine against COVID-19, and we completed the enrollment of our chikungunya Phase III study. So all 3 assets where we will -- where we are either the only in class, best-in-class or first-in-class, and we are very pleased with this progress. Of course, the key event also, not a quarter 1 event, has been very recently our successful NASDAQ listing. And one more time, I would like to thank everyone who contributed to this outstanding success. In terms of financials, Manfred and David will give more details around our financial performance. We had cash and cash equivalents of more than EUR 200 million at the end of March, and this excludes the proceeds from our global offering that we did very recently. Yes, our revenues and particularly here, the product sales are still low and affected -- universally affected by the global pandemic, so we all see now a light at the end of the tunnel and, certainly, people will travel again when travel will be feasible again. With that short introduction, let me start by giving you an update on our clinical programs. I think we talked a lot about our multivalent Lyme disease vaccine candidate in the past. By way of reminder, you know that it is the only program in clinical development today worldwide. We reported good Phase II data following the 2 studies that optimized dose and schedule, and we accelerated, as mentioned during my introduction, the pediatric development in March this year in order to test in this study, children 5 years and above, with the objective to bring the future total population eligible for that vaccine into the placebo-controlled field efficacy study. Yes, this is summarized also on Page 7 of the presentation and provided solid and good data here. We are expecting to progress into Phase III towards the end of next year, which will allow us then to have the efficacy readout based on a single tick season within the tick season 2023. That's, in a nutshell, where we are online. On our COVID program, I would like to spend a little bit more time on since we had not the chance to go through all the data in detail. Again, here, the highlights on the program shown on Page 8 of the presentation, you know that we have an existing U.K. government deal worth up to EUR 1.4 billion for that vaccine, which is the only inactivated vaccine in clinical development in Europe today. We have been able to leverage our existing platform, our existing manufacturing process that we developed for IXIARO, a product that we developed all the way from bench to global licensure. And we combine the inactivated approach with a modern adjuvant, namely Dynavax's CPG 1018. We will go through the key Phase I/II results during this presentation again, and you know that the Phase III is well underway with recruitment reaching almost 80% of our targeted recruitment. Page 9 shows a summary of the safety profile that we observed in the Phase I/II study. And in summary, one can conclude here that the safety profile is as expected for an inactivated vaccine. You know that inactivated vaccines are on the market for more than 50 years already. We see that the product candidate was well tolerated across all the dose groups. We had no safety concerns identified by the independent DSMB. No statistically significant differences between the dose groups, low, medium, high. And actually, also no differences in between first and second vaccine vaccination. So all in all, the safety profile confirms that inactivated vaccines are very nicely tolerated vaccines across the entire portfolio of vaccines that are in the market today. When we look at the immunogenicity on Page 10, you see that we reached, after the second dose, in more than 90% of all trial participants across all the 3 dose groups, significant levels of antibodies to the SARS-CoV-2 virus spike protein. The seroconversion rates in the high dose were 100% and, basically, the geometric mean fold rises from baseline in the high dose was 86 fold. When we look at Page 11 and look at the functional antibodies, you see a very nice dose response on the top left-hand side of the graph, in between the low, the medium and the high dose. So the high dose clearly performed best, giving functional antibody titer levels at or above the level of standardized panel of convalescent sera, for which vaccine efficacy has been reported above 80%. We have been extremely pleased with those results, confirming our development hypothesis. We also saw cellular responses. And here, clearly, T-cell responses by interferon Gamma ELISpot analysis against the S, the M and the N protein. T-cell analysis are still ongoing, but this is also a very positive outcome of this Phase I/II data. On the basis of that data set, we have been able to progress into Phase III, with the Phase III trial ongoing in the U.K. as we speak. And it is the first time that the company is aiming to show effectiveness by immunological comparison against a licensed vaccine. So we are having, here, more than 4,000 adult immunocomparability study. And our endpoint is GMT ratio superiority of our vaccine in a 2-dose immunization schedule, 4 weeks apart against the active comparator. I mentioned already, the study is conducted in the U.K. Of course, protocol is agreed with MHRA, and we are in the process of aligning the development path also with other regulatory authorities. You have seen that Valneva participates in the first -- world's first COVID-19 vaccine booster trial in the U.K. 7 different vaccines are being tested for boostering after different -- after priming with different vaccines, 3 out of the 7 with different dose levels, including ours. And we are very pleased to be part of that and, of course, we are planning additional studies. For us, this is an important point, especially because we see inactivated approach and our approach complementing very nicely in the booster strategies that different companies -- different countries have established and of course, also as an ideal platform for variants. And here, it is important to note that we have already developed viral seed banks, including the seed banks against the South African or the Kent variant. So we are in a position to switch manufacturing and to start manufacturing of variant-based vaccines imminently. Yes, that's our COVID-19 vaccine candidate on chikungunya. Again, by way of reminder, we have the only ones in Phase III today in the world, and we have already enrolled our pivotal Phase III trial fully. The endpoint of this study will be based on an immunological endpoint, so it's 0 protection levels. So we use a surrogate marker. This surrogate marker has been confirmed by the FDA. And this is the so-called accelerated approval pathway. And of course, the first company to get BLA approval in the United States will be eligible for a Priority Review Voucher, which represents, for us, the single largest short-term commercial return. We are differentiating by applying a single-shot life attenuated prophylactic vaccine profile here. And of course, this vaccine fits nicely within our existing commercial and manufacturing capabilities. You'll also remember that we have partnered this vaccine, which is, on the first hand, a vaccine for travelers traveling to areas where chikungunya outbreaks occur, but also, of course, for people living in those areas, and here, we have partnered with CEPI and through CEPI with Instituto Butantan to access the low and medium income countries. In terms of next steps, we have initiated 2 flanking studies. One is the lot-to-lot consistency study in about 400 subjects, and the other one is the antibody persistence follow-up trial. All that will form the basis for our licensure package in adults, and we expect to submit next year. And yes, and then in parallel, we're going to continue the pediatric route, and this will then lead to a label extension post licensure. Yes. So with that update on our 3 highly differentiated and very unique R&D programs, I would like to hand over to David.
Thank you, Thomas. So good afternoon or good morning, everyone, depending on where you are. I'm just going to say a few words and talk to a couple of slides before handing over to Manfred to do the financial report. So Slide 17, I think Thomas mentioned upfront, and I just want to emphasize what a strong cash position we have right now. So we have EUR 235 million at the end of Q1. Our cash business is higher than it was at the end of 2020, and that's based on continuing to collect payments from the U.K. relating to our COVID partnership. No statements have been triggered by the ongoing excellent execution of the COVID program, including the Phase I/II results that Thomas has explained earlier. The cash position is also supported by a funding mechanism for the ongoing capital investment in our Livingston plant in Scotland and the U.K. clinical trials. As Thomas said, we are absolutely delighted by the recent U.S. IPO, something that Thomas and I are personally working on for some time and many of you will appreciate. I would like to continue to also emphasize our thanks to the internal team and also to the banks and lawyers who provided excellent support. In a market or a capital market, it's not quite as frothy as it was for most of last year. We raised more than $100 million, and those funds are not included in the cash -- on the cash number for Q1. So in summary there, we are continuing to be well positioned to execute on our strategy, including acceleration of our key clinical programs. So next slide, please, that's Slide 18. So I want to highlight some key dynamics that relate both to our commercial operations and to guidance. There'll be no surprise to you that the key factors here both related to COVID. So firstly, on the commercial business, and Thomas did make a comment earlier, whilst we are seeing some small improvements in our IXIARO volumes, the recovery of the travel industry seems to still be some way off. The factors highlighted on this slide are widely known, of course. These factors mean that we want to be even more conservative with our guidance. The pandemic just hasn't gone away, as we all know, but we also know that the vaccine -- that vaccines are the light at the end of the tunnel, and we are pleased to be a part of that. On this slide, I probably don't have to highlight, the terrible havoc that's ongoing in India while they deal with the outbreaks there and try to roll out their vaccine program. And we see some inconsistency from country to country, obviously, where Canada is now catching up, but the -- was way behind the U.S. in terms of its rollout. And Canada was a key market for us, for example, for DUKORAL.So secondly, and then this is consistent with what we've said before. We're not giving guidance on COVID for now. Thomas reported the excellent progress that we're making with our vaccine. Phase III equipment is going well. We have a clear plan with the MHRA, which is the U.K. regulator. And then what's happening in time though to the ongoing execution is that we're having other discussions outside the U.K., both in terms of supply deals and in terms of the clinical and regulatory pathway. And within all of that, we're reviewing the outlook for both boosters and variants. And the announcement this morning was a very important announcement. So we will participate in the U.K. booster study. And we'll participate both at a full dose and a half dose level. In turn, and in addition to those of dynamics, we've got to decide, in conjunction with our key customers, if we might want to switch at some stage to a variant-based vaccine. And of course, that could impact supplies and time lines. And therefore, I hope you understand and agree that for the time being, we can't give clear guidance. But rest assured, we're making the best decisions we can to address the evolving COVID situation. And when we are in a position to do so, we will give COVID guidance. So we have basically brought down our revenue guidance as a consequence for the time being. We feel that's a prudent and conservative position to take. And hopefully, what I've said will help you understand the reasons for that and also set the tone for the rest of the financial report. So I'd like to hand over to Manfred.
Yes. Thank you, David. And also from my side, good morning, good afternoon to everyone on the phone. I would like to continue the finance section with providing a bit more details on the Q1 product sales, which in totally amounted to EUR 16.1 million. Sales of third-party products for the first time included revenues from Encepur and Rabipur, which was sold by our commercial infrastructure in line with the distribution agreement signed with Bavarian Nordic by the end of 2020, and that contributed a solid EUR 2.7 million to our Q1 top line. IXIARO sales to U.S. military still related to the base year of the contract signed in September 2020, and delivered about EUR 12.3 million of sales during Q1. As we continued seeing the travel industry being impacted by COVID-19-related restrictions, our Q1 sales of DUKORAL and IXIARO were still relatively muted, and in combination, added about EUR 1.1 million to our top line. When you look to the chart on the right, you can see that our overall product sales were quarter-on-quarter down by about 48% at constant exchange rates. And almost all of our sales were delivered through our own commercial infrastructure. Gross margin on product sales ended up at around 41.7%, impacted by compressed product sales and some idle capacity costs during the first quarter. Next slide, please. Here, I want to briefly walk you through the Q1 profit and loss statement. I want to highlight those areas with the most significant changes to previous year. We already, I think, sufficiently covered the product sales part, and I wanted to highlight that we saw a sizable increase in the revenues generated from collaboration and licensing agreements, growing from EUR 2.5 million to EUR 7.1 million during the first quarter of 2021. This included about EUR 2.6 million of revenues generated through the collaboration with Pfizer on really 15 line. And also saw about EUR 1 million incremental revenues related to the agreement recently signed with Instituto Butantan in relation to the chikungunya program for the low- and medium-income countries. In this context, we also reported our COGS line, which is now showing all the splits between cost of goods sold and cost of services in order to better reflect the impact of the growing nonproduct-related sales on this P&L position, which also clearly shows declining cost of goods in line with lower product sales and the effect of higher collaboration service revenues on the cost of services line. Our R&D investments continued growing significantly and more than doubled during the first quarter of 2021, in line with our R&D portfolio progressing into late-stage clinical development, but primarily impacted by incremental COVID-19-related R&D spend amounting to more than EUR 15 million during Q1. Marketing and distribution expenses declined considerably compared to the first quarter of 2020, in line with lower sales. And I think here, it's important to also note that in Q1 2021 only about EUR 1.2 million of incremental launch preparation and market access spend related to the chikungunya program was included. So on a like-for-like basis, marketing distribution spend reduced by about 40%. Our G&A spend continued increasing materially, mainly driven by nonoperational costs, mostly related to the corporate projects such as the U.S. IPO preparation as well as including some noncash effects related to the company's stock option program. And the GLA line also captures many of our senior management, including [ indi ] so the share price appreciation also drove some higher share-based compensation. A few more words regarding the net income reported on the financial results. This was driven by foreign currency valuation gains, primarily related to the British pound denominated cash and balance sheet positions, which more than offset increased interest charges related to the debt financing agreement with OrbiMed and Deerfield as well as the interest charges related to the refund liabilities. In combination, the finance results contributed a net income of EUR 3.4 million to the Q1 2021 P&L. And finally, EBITDA level shows a total loss of EUR 28.3 million, which is mostly driven by the high level of R&D investments and by compressed product sales. On the next slide, I want to show the additional impact of the COVID-19 activities on the company's income statement, also showing that a large part of the Q1 EBITDA is attributable to the COVID-19-related investments in R&D. And from the total EBITDA of EUR 28.3 million, about EUR 20 million related to the COVID business, leaving about EUR 8 million related to Valneva's core business, excluding COVID. Also important to note that no COVID revenue has yet been recognized to date. And also any payments received for the clinical trial activities as part of the U.K.-COVID agreement are not yet recorded in the company's income statement. On the next slide, we thought it would also be helpful to also add a few comments on the Q1 balance sheet. And here I want to focus on some of the most material movements compared to the position we presented for the full year 2020 financials. And while this slide shows the entire balance sheet, I will want to highlight those areas to also help better understanding some of those movements on our balance sheet. First, I wanted to highlight that the significant increase in inventories, growing from about EUR 27 million to a level of EUR 97 million in Q1 was a result of building COVID-related inventories for commercial manufacturing. The third increase in our cash position had been mentioned previously already by Thomas and David. And also worth noting that we will see net proceeds from the recent global offering, further increasing our cash position by the end of the second quarter of 2021. In addition, I would like to highlight the further increase in contract liabilities, which related to cash considerations received from the U.K. government related to the COVID supply agreement. And as we start supplying COVID vaccines to the U.K. government, we will gradually see these contract liabilities moving into the P&L. We this, I want to conclude the finance section. And I would like to hand back to Thomas to give an update.
Thank you so much, Manfred. Thanks a lot for the report. With that, I come to Page 24 of the presentation. And here, we would like to summarize the key upcoming catalysts and potential inflection points. For Lyme, what are we expecting this year? We are expecting, during the year 2021, some follow-up time points from the ongoing Phase II studies. Of course, we expect the progression into the full children age groups because we go HD escalation right now on the study [ Phase 221 ]. For chikungunya, of course, this is the single largest short-term trigger, and this is clearly on the R&D side, here the Phase III data. And in the Phase III data, we expect, as announced previously, mid of the year. We have completed the enrollment. Testing is ongoing. Of course, there's still a bit of uncertainty around the exact timing, but mid of the year is certainly still confirmed. And on the COVID-19 activities, let me start also here with the R&D part of things. We are expecting Phase III data in the third quarter. This will be then followed by regulatory submissions. And we are expecting, of course, assuming clinical data positive, an approval thereafter. And we have already announced earlier that we're going to initiate additional trials to strengthen our product candidates differentiation. You've seen one announcement today, with the participation in the booster study of boost, and there will be more that we are currently evaluating. And as David mentioned during his initial update, on the commercial side, we are expecting further supply deals, of course, all subject to negotiations and available capacities. With that, I would like to hand back to the operator to take your questions.
[Operator Instructions] And your first question comes from the line of Max Herrmann at Stifel.
Congratulations on, obviously, completion of the NASDAQ IPO. I actually got 4 questions, if I may. Firstly, on the financials, first quarter results. You've obviously successfully completed the Phase I/II results, I think, early April. Is any of the payments reflecting sort of that milestone in the first quarter? Or is that all to be received subsequently? Second question is just on VLA15. You talked a lot about the pediatric acceleration, but I think, perhaps, you also have a year longer to wait before you can initiate the Phase III. So I wonder whether the real impact there is the commercial potential relevant sort of 2-dose regimen versus the 3 dose that you were going to go for originally. And then maybe just third question, which is we've just seen Sanofi and GSK announced successful Phase I/II data. They're going for a field study. So I wonder whether there's any thoughts in your mind about whether any of the regulators will require that. Why are they required -- being required to do a field study with -- see they need to do a field study, when you are not going the field study route.
Okay. Good. A lot of very interesting questions, Max, as usual. So maybe I'll start with the 2 latter questions and let David talk a little bit about the financials. And let me start with Lyme. It is that, basically, we -- the study 202 revealed that the longer schedule, 0 to 6 substantially improved the immune profile, immunogenicity profile over the study 201, meaning this original schedule 012. With this longer schedule and the necessary follow-up period of 6 months prior to granting an end of Phase II meeting, there would have been no way to start the field efficacy trial this year. So this means anyhow, since we are talking a seasonal thing here, we are at trial initiation for the Phase III in 2022. Therefore, there's no delay caused by the study 221 in connection with Lyme. So we plugged this study in, and it's -- because we have the time to do that, number one; number two, because it gives us the opportunity to have the full target population in the Phase III, which, in turn, will allow to get the full target population into the label right from the start. Whether the 026 versus 06 is an exploratory arm in this study, which may or may not result in a 2-dose regime and the question whether this is increasing the commercial value of the product, is still under discussion, I would say. And this is a question that, of course, our commercial partner has to answer. On a personal note, I don't think so. And this is maybe on the Lyme side of things. When we come to the COVID part, you will certainly understand, Max, that we're not going to comment on development strategies of other companies. We have concluded that a field efficacy in a placebo-controlled field efficacy study, from an ethical standpoint and from a technical feasibility standpoint in a situation of heavily shifting, drifting epidemiology, is infeasible, considering a reasonable chance to succeed our probability of success. And 1 [indiscernible] authorities have followed our line of argumentation and have consented to an immunocomparability approach, which is not -- which is an approach that is existing in regulatory guidelines. And that's all we can say to -- and want to say on that very topic. David?
Can I just on that point, just a follow-up one thing on the Lyme disease. So you've completed the phase -- the earlier Phase II studies last year. So I'm just trying to understand the 026 schedule, why that would have meant it's not possible this year to have maybe initiated the dosing in the Phase III, had you chosen to ].
So in order to -- so let me calculate backwards to take you through the logic here. In order to have people being protected in a tick season, take whatever tick season you can think about, yes? So let's say, if you want to have people vaccinated and protected for a tick season, you got to have them vaccinated in the September the year before the tick season starts. And this means you need to start the Phase III with all its preparatory activities, with rollouts and so on and so forth, in the early summer. In order to do that, you need to have the end of Phase II meeting in the spring. And we did -- and the end of Phase II meeting requires that you have your 6-month follow-up immunogenicity data fully analyzed and reported, and we don't have that.
Okay. Understood.
Yes. So 201 and 202, we've reported the top line data.
Yes. That's not the follow-up data. Yes.
Yes. So just and on the -- obviously, if we trigger a milestone payment with the Phase I/II data, if we did that, then you would expect the results in payment would arrive in Q2, not Q1.
And your next question comes from the line of Samir Devani at Rx Securities.
I've got 3. I think one on the finances, and then just one on chikungunya and the COVID vaccine. So just starting on the finances. I just wanted to -- just to clarify something on the revenue recognition from for the Pfizer Lyme collaboration. I think previously, you talked in your guidance that you're expecting EUR 20 million to EUR 25 million of recognition this year. I think you mentioned EUR 2.6 million went to the top line in Q1. So are you just confirming that you still expect EUR 20 million to EUR 25 million recognized this year. So that's just on the numbers. Then in -- on 2001, can you just remind me, Thomas, the 2 doses that you're testing from the -- which are they from the low, mid and high, from the Phase I and II? Can you just clarify that for me? And then just on chikungunya, can you confirm whether the single study that's ongoing will suffice for the European regulator? And you mentioned filing in 2022, just wanted to understand what you need to be post reporting the Phase III mid this year before you file?
Okay. Let me -- Samir, very good question. So let me start with the last one first, probably. So basically, what we're going to do for chikungunya is -- on chikungunya, so first of all, we have agreed with both authorities that the accelerated approval pathway will be the one to go. We -- so this means immunological surrogate. The surrogate as the fixed number, has been agreed with the FDA already, and we are still awaiting the final clearance from the European authorities. But we have no doubt that this will be reached very, very soon and before the readout of the study will come. The -- in terms of what is needed for licensure, let me refer back to the slide that I showed about the next development steps. It's -- we have initiated a clinical -- the lot-to-lot consistency study. You know this is a requirement for licensure. You need to show the 3 consecutive manufacturing lots behave identical in the clinic. This study is ongoing and runs in parallel, while the Phase III is being analyzed. The other one is the 6-month follow-up. We are following up people as part of the antibody persistence study for a long time. We are -- we let the study run for up to 5 years because we hope that our vaccine will give a very long protection with a single shot up to 5 years even. And -- but we need according to guidelines, a 6-month follow-up antibody persistence from the people in the 301 study for the filing. And these are the 3 pieces, if I may say so, which are required for that. Do you want to take the other question?
I think Manfred will talk about the revenue guidance and the piece that we didn't talk about.
Yes. I'm happy to take that question, and thank you for it, Samir. So I think overall, when we're looking at Lyme, I think the way to describe this is that revenue recognition is driven on, say, on a cost-to-cost principle, which means, ultimately, it's going to be dependent on how much money we spend. And here, we would still expect to be ballpark in the area we mentioned, potentially a little bit on the lower end of the guidance. But overall, given that we only have recognized EUR 2.6 million in the first quarter, we would still expect to reach the lower end of the guidance we had given in EUR 20 million to EUR 25 million.
[Operator Instructions] And your next question comes from the line of Sebastiaan van der Schoot at Kempen.
My question is regarding chikungunya, the first one. I was wondering if you could provide some guidance on how long those lot-to-lot consistency studies will approximately take. And can you also maybe remind us of whether you'd looked in earlier trials at antibody persistence? And if you could comment on that. And then for the COVID-19, can you maybe expand on how the booster trial is designed? Will there be specific combinations tested? Or is it all randomized? And will the initial prime dose be already accepted for the vaccine, or can it also be investigation of vaccine?
Good. So let me start with the chikungunya part first, Sebastiaan. So basically, on chikungunya, so we are running this trial in parallel. We hope to see a readout on the lot-to-lot consistency in the third quarter this year. We are -- we have shown, as part of our Phase I cohort -- remember in chikungunya, we went straight from Phase I into Phase III because we had this intrinsic viral challenge, homologous challenge, which enabled us to pass the end of Phase II meeting right away. So we showed seroconversion and antibody titers even 12 months after the primary immunization, and they were sustained at the same levels. But unfortunately, regulatory guidelines, as you need to do this, you need to show 6 months also from your final pivotal study cohort. But it's going to be, of course, not something that we are worried about, given that we have shown already a 12-month antibody persistence before. So this is basically where we are on chikungunya, I hope this answers your question. On COVID, well, I mean, David, do you want to take that? Yes, well, I think it's -- yes, it's not that the booster design. We need to think a little bit about what we -- what we can disclose and what we cannot disclose here. So these are not studies, as you have seen that Valneva is sponsoring. And so what has been presented thus far is that these are people who have been primed with different vaccines. And they are being given a booster, so meaning a third shot, homologous, same strains from either of the 7 vaccines. And as David mentioned -- I mentioned it, too, for 3 vaccines also with different dose levels. And by the way, this reminds me that I forgot the question from Samir, on the dose, it's half dose, half volume. And so -- yes, so that's the way that the trial is designed. We cannot -- and I've quickly check, but I don't think that we can say more at this point.
And there is a follow-up question from Samir Devani at Rx Securities.
Actually, the 2001 question wasn't regarding the booster. It's actually regarding the Phase III that's going on now, which of the low, mid and high doses are you testing in that Phase III vis-à-vis the Phase I/II? And while I want, can I also ask -- you mentioned there was a higher share-based payment charge this quarter. Could you just tell us how much that was, please?
In the -- Samir, in the Phase III, we are only testing one dose, and this is the high dose.
One dose, high dose. Perfect.
Yes. So this -- so David, you want to -- or Manfred, you want to take the financial part? Manfred, you can take that one, probably.
Yes. I would probably need a minute to take this information out, but I can come back in a second here.
Okay. Good. So maybe we can then move on to the next question while Manfred is checking your specific point, Samir?
[Operator Instructions] And there is another follow-up question from Max Herrmann of Stifel.
Just a follow-up, just interested in your thoughts about vaccine persistency in COVID and whether there's any -- how do you judge, obviously, before you have data, which approaches might have more persistency? Is there any route to that? Or is it just -- we just have to wait for the data to see, obviously, the definitive answer. But is there a rationale for why you might get a different type of persistency from an mRNA vaccine to inactivated viral vector, or no-vector type approach.
So, very good question, Max. I would say, in general, I mean, science will win and data will drive decisions. It is fair to say that I -- to my knowledge, Pfizer and Moderna reported very recently that they expect to have a booster need after approximately 9 months. Of course, it's the first time that there is -- that the world is seeing antibody persistence data on mRNA stroke on SARS-CoV-2. The 12 months is -- of course, antibody persistence depends a lot on both, on the antigen, on the pathogen itself. So it is -- to draw conclusions on platforms is very difficult. And also, one may expect that activated approaches would have an advantage when it comes to antibody assistance. At least this is something that we have seen in other indications. One has to prove it. And the data has to show it. Yes.
And there are no further questions at this time. Therefore, I would like to hand back to the speakers.
Thank you. Manfred, have you been able, in the meantime, to dig this information out for Samir?
Yes. Yes, I can answer that now. So I think it's in the range of below EUR 5 million. I think that would be a fair guidance.
Good. So again, we had great questions. Thanks a lot for following up. Thanks a lot for following Valneva, for supporting Valneva. And we would -- we look very much forward to speaking again soon. Have a good day.
Thank you speakers. Please stand by.