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Valneva SE
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Good day, and thank you for standing by. Welcome to the Valneva Q1 2022 Financial Results 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 speaker today, Thomas Lingelbach, CEO of Valneva. Please go ahead.
Good day, and welcome to our quarter 1 financial results and corporate update call. Pleasure to be with you again today. Yes. So basically, the quarter 1 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 U.S. FDA and again, 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 EUR 21.8 million in quarter 1 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 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 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, we have been able to determine also dose and schedule for the Phase III, which we expect to commence in the third quarter this year.
The vaccine is based on a multivalent recombinant subunit approach covering the 6 different serotypes prevalent in the Northern Hemisphere so that the vaccine is designed to protect against Lyme disease on both sides of the Atlantic. And the vaccine, as we reported many, many times in the past, is based on validated and proven mode of action.
Specifically on the news regarding pediatric data or first pediatric data, the first Phase II study that we conducted, study VLA15-221, included 625 participants aged 5 to 65 years of age. We saw both in the adult as well as in the under 18 year, which we call pediatric participants, a very strong immunogenicity profile, and we reported the 18-plus data already in February and now the 5 to 17 in April.
In the participants 5- to 17-year-olds, of course, as expected, the vaccine was found to be more immunogenic as compared to adults. And we even saw that we could already obtain a good level of immunogenicity after 2 doses of the final dose schedule that we have determined mainly a 3 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 III study is still planned to start in the third quarter this year. Please keep in mind, we are talking about a 3 dose priming, months 0, 2 and 6. So in order to have our study cohort fully vaccinated for the tick season 2023, we've got to start in the latter part of this year. And this is a study that would include participants all the way from 5 years on and apply the, as I said, the 3-dose primary vaccination schedule.
The clinical readout is achieved after one season already. It's projected by the end of 2023 or tick season nature should be feasible earlier. The Phase III start 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's the only program on the planet today that has shown positive pivotal Phase III data, final positive pivotal Phase III data and 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 topline data at this point only.
We have also initiated the adolescent Phase III trial. This is a post marketing activity. So we will seek initial licensure in everyone 18 years and above, and then 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 in the partnership with Instituto Butantan for 2 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 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, 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 as well -- existing commercial and manufacturing infrastructure in a market that we see clearly exceeding EUR 0.5 billion annually over time, of course.
What is the outlook? We have initiated the presubmission activities with the FDA. I mentioned already that we completed the final Phase III data readout, basically confirming what we saw already earlier, namely an excellent zero response rate close to 100% and we saw positive lot-to-lot consistency data. We wait for the follow-up. Then antibody persistence study is ongoing. We expect a subset of respective participants to be followed for up to 5 years because we hope, of course, that our vaccine will protect for a long time after a single shot. And I mentioned the adolescent Phase III 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 cold virus COVID-19 program in the clinics in Europe as we -- that the beginning partially already approved. It builds on our IXIARO manufacturing technology but combines this conventional approach with a modern Toll-like agonist in adjuvant CpG 1018 which is supposed to drive the immune response stronger towards CH1. We received, as mentioned, the MHRA conditional marketing authorization and of course, the emergency use authorization from the Bahrainian NHRA. And as I mentioned, during my introduction, EMA rolling review still ongoing.
I think we have reported in the past 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 supposed to still be delivered this year subject to product approval of course, and some of the deliveries that we have done already to Bahrain.
The basis for licensure is the immuno comparability. We showed superiority against AstraZeneca's product and a significantly more favorable tolerability profile. We also reported very positive topline homologous booster data showed in vitro neutralization against Omicron and Delta and other variants of concern. And we are in the process of expanding 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 to 55. In the U.K., we got 18 to 50. But then, 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 plus.
We reported last night that we initiated heterologous booster study. We understand that this is, of course, important that our vaccine can also use in people that got time before, be it through mRNA, multiple vaccinations or -- and/or natural infection. So this is the study that will, in the proper setting, evaluate that. And we are very glad that we have finally been able to initiate the study, not so easy these days in the environment of COVID.
So all the, what we would call the adult adolescent activities. So 2 to 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 and 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 get the necessary sample size and the necessary participants to the respective studies.
Yes, with that, general business update, I would like to hand over to Peter, who's going to 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 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 U.S. military. This decrease was anticipated according to the planned shipment schedule. As the footnote of the slide indicates, IXIARO/JESPECT sales outside of U.S. military performed much better than 1 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 1 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.
And finally, as already mentioned, we are able to report the first sale of our COVID-19 vaccine with the 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 release of provisions for share-based compensation at the related social security cost.
The cost of [indiscernible] share programs for certain employees as well as the cost of social security on our equity plans depend on the development of Valneva's 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 had 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 taxes 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 the 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 related 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. So 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-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 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 1 year ago and EUR 347 million at the end of 2021. We've set a 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 to EUR 590 million. The distribution of total revenues by category may, however, defer from the figures announced in February, given the uncertainty 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.
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.
[Operator Instructions] And the first question comes from the line of Samir Devani from Rx Securities.
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 EUR 160 million to EUR 200 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?
Samir, Thomas speaking.
So yes, we are expecting a second shipment to Bahrain later this year. Then on chik, the -- as you know, we have agreed with the FDA a surrogate marker. So there is -- so this means that the correlate of protection in a way is -- 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, we -- 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.
Yes. On the guidance on R&D, yes, we do maintain the guidance we gave early this year, it would be EUR 160 million to EUR 200 million, we maintain that one.
Next question is from the line of Maury Raycroft from Jefferies.
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?
Yes. 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 respective 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.
Next question comes from the line of Max Herrmann from Stifel.
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?
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, 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 -- 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.
Next question comes from the line of Seamus Fernandez from Guggenheim Securities.
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 -- 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.
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], 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 6 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 in 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.
[Operator Instructions] Next question comes from the line from Jean-Jacques Le Fur from Bryan Garnier.
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 U.S. military next IXIARO shipments, sorry, for U.S. military, if any, for the rest of the year?
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 noncirculating strain that was achieved by -- during a certain period of time in a specific trial have 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 U.S. military is due?
Yes. So it is planned for end Q3.
Thank you, Franck.
Next question comes from the line of Max Herrmann from Stifel.
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 outside 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.
Next question comes from the line of Sebastiaan van der Schoot from Kempen.
Two from our side. The first one is on the type of questions that we're seeing at PR. 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 U.K., the U.K. boost trial? Is there anything different in the regimen? And what will be the primary endpoint in that study?
Very good question, Sebastiaa. 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 across all the data sets measure both binding as well as neutralizing antibodies, for example, yes?
And also, both have shown to correlate highly, yes and the -- of course, one of the things where, for example, wants to have both, whereas others we are 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 6 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 the booster, you are addressing a very good question. And it's one of the questions that we are receiving on almost now on a permanent basis today after we filed the announcement last night that yes, there are potential differences.
Let me remind everyone about the COV-Boost study. The COV-Boost study was a study in the U.K. conducted at the moment in time where people have been primed around 3 months before they got the booster. So which means -- and this was -- and the COV-Boost had to be conducted at the time because it was designed to inform the JCVI in the U.K. about their decision, which vaccine candidate or which vaccine to use for the winter 2021, 2022.
So a, so people have still pretty high titers at the point they were boosted. The second was we had an elderly cohort. So the average age was above 70 years. And so now we have the setting that we are now seeing in our study is a more real-life setting. So, a, it is a setting where people will be immunologically in need of a booster. So this means at 6 months. So 6 months ago, either last vaccination or natural infection. On hand, immunologically, as I said, in need of a poster. And b, we will go across the entire age spectrum in order to also see potential differences in age. But these are the 2 major differences in between the COV-Boost study and what we are seeing today. As I said, one about the hematological booster need, the age and in reality, a third one, mainly that we include also the natural infection, which never was included in the COV-Boost study.
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 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 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.