Valneva SE

Good day and welcome to our quarter one financial results and corporate update call. Pleasure to be with you again today. Yeah, so basically the quarter one has again been marked by excellent progress on our clinical programs. We have been able to report further positive phase two 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 VLA 2001, we received MHRA conditional marketing authorization in April, NHRI emergency use authorization, including First vaccination in Bahrain. And the EMEA 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 going to go more into the details of the program. With regard to our top line and cash position, we have recorded total revenues of 21.8 million euros in quarter one 2022. We had actually first sales from first COVID shipments into Bahrain. And we see some positive signals in the travel vaccine market. And again, Peter will detail it a bit further. And our cash position remains strong at 311.3 million euros at the end of March. With that, I would like to go into the details of the programs. 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 path track designation granted, exclusive worldwide partnership with Pfizer. And we have gone through a number of phase one, phase two trials, to determine final dose and final schedule. And 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 of 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. And 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 third phase two study that we conducted, study VLA15221, 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 two doses of the final dose schedule that we have determined, namely 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 three-dose priming, months zero, two, and six. In order to have our study cohort fully vaccinated for the tick season 2023, we got to start in the latter part of this year. This is a study that would include participants all the way from five years on and apply, as I said, the three-dose primary vaccination schedule. The clinical readout is achieved after one season already is projected by the end of 2023, or a six-season later should it not be feasible earlier. The phase restart will trigger a $25 million milestone payment by Pfizer to Valmiva. Moving on to chikungunya, you also are well aware of the fact that our chikungunya vaccine candidate called VLA-1553 is the most clinically advanced chikungunya vaccine program worldwide. It is the only program on the planet today that has shown positive pivotal phase 3 data, final positive pivotal phase 3 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 top-line data at this point only. We have also initiated the Adolescence Case Retrial. 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 TIPI and a partnership with Instituto Butantan for two reasons. Number one, to help conducting those studies, which are, of course, conducted under IND, 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, Brexit therapy, fast-track, EMA prime designation, and of course, as we have expressed many, many times, the first company to achieve VLA approval will potentially be eligible for a 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 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 zero response rate, close to 100%. And we saw positive flow-to-lot consistency data. We wait for the follow-up. Then, 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. And 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. BLA 2001, our COVID vaccine candidate, it is still the only inactivated old virus COVID-19 program in the clinics in Europe as we said at the beginning partially already approved. It builds on our manufacturing technology but combines this conventional approach with a modern agonist which is supposed to drive the immune response stronger towards PH1. We received, as mentioned, 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 is 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 is 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 immunocompatibility. We showed superiority against AstraZeneca's product and a significantly more favorable tolerability profile. We also reported very positive top-line hemologous booster data, showed in vitro neutralization against Omicron and Delta and other variants of concern. And we are in the process of extending our label gradually, which is expected post the initial licensure of the vaccine. It's being shown on page 11 of the presentation, initial licensure, primary immunization 18 to 55. In the UK, 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 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, 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 two 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. 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 €21.8 million, down €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 VLA 2001, 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. Ixiara 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, Ixiara chest bag sales outside of U.S. military performed much better than one year ago and almost quadrupled. For Ducoral, we can also report a significant recovery of our business, with sales reaching 2.5 million euros compared to 100,000 euros one year ago, or a total of 2.4 million euros for the full year of 2021. The increase in sales of Ixiara outside the U.S. military and Ducoral is a result of a recovering travel market, which presumably also includes some inventory replenishment in the distribution chain. Third-party products, more than double versus prior year, reaching sales of 5.6 million euros. The main drivers for this increase are higher sales of the Bavarian Nordic products, Ensipur and Rabipur, across primarily UK, France and Austria, where we started to distribute these products at the end of fiscal year 2020. And finally, as already mentioned, we are able to report the first sales 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 5.6 million euros. This line primarily includes revenues from the FISA R&D collaboration for lime, as well as manufacturing services provided to third parties. Looking at our cost, 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 at 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 Valdeneva's share price. In total, in Q1 of 2022, we recognized an income of 11.7 million euro that was offset against the different expense lines. This compares to a cost of 4.8 million euros in Q1 of 2021, so a year-over-year comparison, we have a positive delta of 16.5 million euros. Excluding that special effect, our Q1 cost would be broadly in line with prior year. Financial expense and income tax is reported at 7.6 million euros compared to an income of 3.4 million euros 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 26 million euros is 1.7 million lower than in the prior year, while EBITDA reached 13.3 million euros compared to 28.3 million euros 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 exceeds sales, which is mainly driven by ramp up cost as we start commercial manufacturing. We invested 21 million euros in R&D for COVID, following an R&D investment of 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 311 million euros compared to 236 million euros one year ago and 347 million euros 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 430 to 590 million euros. 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 catalyst 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 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 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 approval specifically for the EMA. You know, 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 may be deemed sufficient to grant a conditional marketing authorization of positive CHMP opinion this quarter. And, yeah, 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 and we are working on the additional clinical studies the one that we announced yesterday evening for example 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'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 1 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 1 if you wish to ask a question. And the first question comes from the line of Samir Devani from RE 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. Other shipments are left to fulfill the Bahrain order, and 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 R&D previously guided at 160 to 200 million, is that range still applicable? And then the final question is just on the Chikungunya trial in adolescence 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, Samia. Thomas speaking. So yes, we are expecting a second shipment to Bahrain later this year. Then on CHIC, as you know, we have agreed with the FDA a surrogate marker. So this means that the correlate of protection, in a way, has been derived through passive transfer and non-human climate. So there is a technological threshold that determines, in a way, what we called in the old days, zero protection, which, of course, is, at this point in time, now basically called zero response in the new regulatory language, but it is basically the indicator for efficacy. So, yes, an immunological endpoint. On the execution timeline and the readout, you have, of course, perfectly noted that we have not given guidance right now on the execution timeline of the study and quite frankly speaking, we do not feel comfortable to do that at this point in time. As I said, we are not doing it directly ourselves. We are working through a partner and we are at the beginning of the whole trial setting. We have not yet enough visibility to really say how long it will take, but we hope that we will get this visibility very soon and then We will, of course, update our guidance accordingly. Let me hand over to Peter to take the financial question.

Yeah, thank you, Thomas. Yeah, on the guidance on R&D, yes, we do maintain the guidance we gave early this year of €260 million to €200 million. 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 30th deadline, and how these timelines are affected by current dialogue with EMA.

Yeah. Excellent question, Marie, of course, as expected. I mean, as you all know, we have filed in our respective documentation, including URD and 20S, that the European Commission and its member states have certain rights to terminate and or reduce orders if the 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, who then 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. 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, 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 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. 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 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, you know, make or provide any expectation at this point in time when this is going to be.

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

Thank you. Next question comes from the line of Marks Herman from Stifel. Please go ahead.

Great. Thanks very much for taking my questions. Actually, most have been asked, but one question just on VLA 1553. Could you give us a little bit of detail what the pre-submission areas of discussion are with the FDA or give us a bit more clarity in terms of what that process entails. Thank you.

Hi, Max. Good to hear your voice. So, yeah, 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 and how is super critical, and this is exactly where we are at this point in time. And this is what we are doing. It's not on the what, I would say, it's more how.

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

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

Okay, great. Thank you very much. You're welcome.

Thank you. Next question comes from the line of Simus Fernandes from Guggenheim Securities. Please go ahead.

Hi, this is Evan Wang on for Samus. I want to follow up on the EC conversations. Do you remain confident in the full purchase of the 24 million doses in 2022 and up to 60 million in 2022 to 2023? And as a second question, on the heterologous boost 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 in? Thanks.

Yeah. Yeah. So let me start probably with the second part of your question first, if I may. So, yes, 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 parenthesis, ready to be boosted. So 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 COFUS study, for example. And so... 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. And 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. And then there is, for us, there is not really an added value of an active comparator in a 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 amnestic response in a heterologous setting and that we are 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 DEC in the past. As I mentioned earlier to one of your questions, the dialogue has been initiated. We are in the midst of this process. We have at this point in time no further insight.

Got it. Thank you.

Thank you. As a reminder, if you wish to ask a question, please press star one. Next question comes to the line from Jean-Jacques Lefour from Brian Garnier. 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 mRNA vaccines, for example, the 70%, 90% and so on. How do you think the label could look like for your vaccine? And do you think it could be harder to promote your vaccine without this simple figure? This is my, or not difficult, sorry. This is my first question. And the second one is, when could we expect the next shipments for US military next Xero shipment, sorry, for U.S. military, if any, for the rest of the year. Thank you.

So let me start with the first question and then I'm going to hand over to Frank 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 am more than 30 years in the vaccine business. I don't think that a percentage of a of, let's say, effectiveness against a non-circulating strain that was achieved during a certain period of time in a specific trial as 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. Frank, do you have any answer with regards to when the next shipment, the U.S. military, is due?

Yes. So it is planned for NQ3. Thank you, Frank.

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 Herman from Stiesel. Please go ahead.

Great. Thanks very much for taking a follow-up question. It was just on following the MHRA approval of the LA 2001. Has that changed sort of negotiations with other potential partners? vaccine purchases 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. And 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.

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

We are working on it. Max, we have not yet. This is the reason why we have not provided guidance yet. Because, 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.

Thank you. Next question comes from Sebastian from Kempen. Please go ahead.

Hi guys, thank you for taking my questions to from our side. The first one is on the type of questions that the CMHP asked. The PAR mentioned that the email did not consider the submission sufficient. Was it based on the efficacy data set or something else or CMC? And then regarding the new trial, the heterologous boosting trial, how does that exactly differ from the trial that you did with the UK, the UK boost trial? Is there anything different in the regimen and what will be the primary endpoint in that study? Thank you.

Very good question, Sebastian. So basically, as we said in the past, we have pre-agreed a pivotal study for COVID. And we have pre-agreed the endpoints with both regulatory agencies and the MHRA as well as FEMA. Since we have delivered on all endpoints in the study, so which means we met all endpoints in the study, And this means the primary endpoints, the secondary and the tertiary endpoints, 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 immunocompatibility. 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 used an example that, and of course, we cannot disclose all the level of details, but we used 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, measures both binding as well as neutralizing antibodies, for example. And also, both have shown to correlate highly. And, you know, of course, one of the things where, you know, for example, the EMR wants to have both, whereas others were okay with just one. And then we have a few other things where we are now seeing additional requests, for example, on CMC. But as I said earlier, we have responded to all of the questions received. We responded to it in six working days, and we hope that with what we have submitted at this point in time, it's good enough for the EMA to finally assess this product candidate hopefully in 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 a almost now on a permanent basis today after we filed the announcement last night. Yes, there are substantial differences. Let me remind everyone about the COFU study. The COFU 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 vaccine. So which means, and this was, and the proof booster 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 stroke 2022. So A, so people had still pretty high titers at the point they were boosted The second was we had an elderly cohort. So the average age was about 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 after six months, so six months, a go either last vaccination or lateral infection. So, hence, immunologically, as I said, in need of a booster. And B, we would go across the entire age spectrum in order to also see potential differences in age. So, these are the two major differences in between the COVBOOST 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 COF-BOOST study.

Okay. Great. Thank you very much.

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

For further remarks, thanks a lot. Again, thanks a lot for following us so closely. We look forward to continuing our close dialogues here and will update you as soon as we can, especially on the process and progress in connection with VLA 2001. With that, again, many thanks and have a good remainder of the day. Bye-bye.