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spk04: Thank you for joining us to discuss Velneva's nine-month 2023 results and corporate update. It's my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the nine months ended September 30th, 2023, which were published earlier today, available within the financial reports section on our investor website. As always, I'm joined by Valneva's CEO, Thomas Lingelbach, and CFO Peter Buehler, who will provide an overview and update of our business, as well as our key financial results for the first nine months of the year. There will be an analyst Q&A session at the conclusion of the prepared remarks. Before we begin, I'd like to remind listeners quickly that during this presentation, we'll be making forward-looking statements, which are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these forward-looking statements. You can find additional information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French Market Authority, which are listed on our company website. Please note that today's presentation includes information provided as of today, November 9th, 2023, and Valneva undertakes no obligation to revise or update forward-looking statements, except as required by applicable securities laws. With that, it's my pleasure to introduce Thomas to begin today's presentation.
spk08: Thank you so much, George, and good day. Welcome to our nine-month financial report and general business update. Let me start with our R&D highlights. We are progressing full steam towards potential licensure of the world's first chikungunya vaccine, where we still see the PDUFA date towards the end of this month. On Lyme disease, the phase three study Valor with Pfizer continues. Cohort one completed the first six seasons, and current cohort two is nicely enrolling. As previously discussed, we have reinitiated the Zika vaccine development and anticipate a clinical trial start early next year. On the commercial business, with total product revenues of more than 100 million euros, we have seen an almost two weeks increase on non-COVID sales as compared to prior year period. And as such, we are on track to meet our 2023 sales guidance of 130 to 150 million euros. We remain to have a strong cash position with cash of €171.3 million at the end of September. Let me go straight to chikungunya. As you know, this is our product candidate called BLA-1553, a live attenuated vaccine candidate under FDA priority review. It is the first chikungunya vaccine that reported positive phase III data at all trial endpoints. We submitted the BLA. In the meantime, also filed with the European Medicines Agency and Health Canada. And the vaccine has very distinct features. We demonstrated long-lasting high-zero response after a single shot. We see already 100% response after 14 days and a favorable safety profile, regardless of prior infections, as recently reported as part of the study in children in Brazil. We are preparing for launch. We are investing in making sure that we can supply the product as early as possible. And as previously described, BLA 1553, especially from a traveler's perspective, fits perfectly within our existing commercial infrastructure, but also in the industrial infrastructure. By way of reminder, we see different markets on that, non-endemic, meaning travelers, military, and outbreak preparedness in the Western world, and endemic use in LMRC, where we have partners with CIPI and Instituto Butantan. You may remember that, of course, the single largest short-term reward on this development program is the potential award and sale of the PRV upon VLA approval. which we have still included in our financial projections, the level of roughly $100 million. The ongoing study in Brazil in adolescents, we reported already the positive initial safety data and final immunogenicity and safety data on the so-called Part A is still expected this month. With regards to the development outlook, we continue to work collaboratively with FDA to align on our post-approval phase four program. And we have additional studies ongoing, meaning antibody persistence study that we will really follow through for at least five years. And the two-year time point is still expected towards the latter part of this year. And the adolescent trial data is expected to support the potential label expansion in licensure Brazil, but also supported to really add on to the existing licensure processes, especially with the European-made medicines agencies. Anticipated future trials will include co-vaccination, pediatric special population, and as mentioned, phase four effectiveness. Turning on to Lyme, page number eight, This is our multivalent recombinant protein-based vaccine candidate addressing Lyme disease. It's the only Lyme disease program in advanced clinical development today. It's exclusively worldwide partnered with Pfizer. And we have the phase three well underway, which is sponsored by Pfizer and supported by positive results for three phase two clinical studies including the first pediatric and elder lessons data, including prime boost and anamnestic response data. It is, as we have reported multiple times, hexavalent or six-valent vaccine that addresses the most prevalent serotypes causing Lyme disease in the Northern Hemisphere. And that's why this vaccine really targets people living in risk areas of Lyme disease on both sides of the Atlantic. It is a rather de-risk program since it follows established modes of action for Lyme disease vaccine candidates that were shown earlier on. It's FAST-TRACK designated by US FDA. The phase three efficacy study, we have shown it in the past, 9,000 participants in the final target population, meaning everyone about five years of age. Randomized one-to-one vaccine against placebo in two-to-one in between North American and European sites. Primary endpoint, rate of confirmed Lyme disease after two consecutive tick seasons, meaning after prime boost. And secondary endpoint includes the rate of Lyme disease after the initial first Lyme season, meaning primary vaccination, or in other words, three primary doses. and then other secondary endpoints as defined in the SIN3 protocol. We have two cohorts. As mentioned before, the cohort one is entirely enrolled, is now expecting the next booster shot prior to the season 2024, and the enrollment of cohort two is well underway. If everything goes to plan, Pfizer aims to submit regulatory applications in the United States and Europe in 2026. In terms of trial updates, we have two studies that are currently ongoing. The Valor vaccine efficacy study, as I just described, and basically here we expect the last subject out towards the end of tick season 2025 when the first initial readout is expected. In parallel, there's also a pediatric safety study ongoing with the first subject achieved in December last year. The enrollment was completed in the summer of this year. It's more than 3,000 children there, and we target completion by the end of this year. then there will be the follow-through period as well. Turning to Zika, page 11 of the presentation, we have decided to reactivate this development of a Zika virus vaccine candidate following the theme and our experience on vector-transmitted diseases, but also diseases that may be developed under an accelerated approval pathway. Zika viral disease remains a significant, a very significant unmet medical need. And we believe that given this special target population for a potential Zika vaccine that our technology leveraging the proven and licensed platforms for ICSIARO on the one hand side, but also the COVID vaccine by the year 2001 may provide an excellent vaccine solution for this disease. And as mentioned before, we plan to reinitiate phase one early next year based on updated formulations that we have. Looking overall at the pipeline of Valneva, page 12, you see we focus strongly on the two late-stage assets that we just mentioned, put Zika back into the active clinical development program, We continue to evaluate partnerships for our HMPV candidate that successfully completed the preclinical proof of concept and are currently focusing our preclinical resources mainly on the Epstein-Barr virus. And with that overall business update, especially focusing on R&D, I would like to hand over to Peter.
spk07: Thank you, Thomas, and good morning and good afternoon to all of you. Now let's look at the financial review for the third quarter of fiscal year 2023. Product sales reached 106.1 million euros and grew 42.6% over the same period in the prior year. At constant currency, product sales grew 45.8%. The strong growth is driven by all product lines, with Xero growing at 119.4% over prior year or 126.7% at constant currency. Ducoral at 142.7% at constant currency, and third-party products at 61.1%. This excellent sales performance is primarily driven by the recovery of the private travel market, but also by price increases across the board. COVID-19 vaccine sales at the end of September are unchanged from the end of June and relate to a pre-existing contract with the Kingdom of Bahrain. Moving on to the income statement, total revenues reached 111.8 million euros versus 249.9 million euros in the first nine months of 2022. In the prior year, Valneva had recognized significant other revenues derived from its COVID program, which explains this decrease. Looking at expenses, we observed a significant decrease in cost of goods and services from over 200 million euros in the nine months of 2022 to 74.8 million euros at the end of September 2023. Prior years, cost of goods and services were heavily impacted by one-off items related to the wind-down of our COVID-19 program. The gross margin of both Ixiaro and Ducoral is still below pre-COVID levels, but improved versus the first half year. Cost of goods are adversely impacted by Ixiaro batch write-offs in our Scottish manufacturing sites, and high sales volumes in indirect markets, where our average selling price is lower than in direct markets. In addition, cost of goods include a total of 9.3 million euros related to the launch preparation of the company's chikungunya vaccine candidate. Research and development expense decreased from 75.4 million euros in the first nine months of 2022 to 42.2 million euros in the current year. That decrease is exclusively driven by the lower spend on Valneva's COVID vaccine program, At the same time, the cost rated to the Zika vaccine candidate increased as the company has been working to its re-initiation of a clinical development program. Marketing and distribution expense increased significantly year over year from 13.1 million euros to 33.9 million euros. The increase is mainly related to higher pre-launch costs for our COVID-approved chikungunya vaccine candidate that more than tripled versus prior year. In addition, prior years spent had a positive impact related to employee share-based compensation. G&A's expense increased from 23.3 million euros in 2022 to 35.1 million euros in 2023. In the prior year, all expense lines had a favorable effect for a total of 30.5 million euros related to employee share-based compensation driven by the share price development. The increase in other income from 7.5 million euros to 17 million euros is mainly related to the recognition of the grant received from Scottish Enterprise. The company's operating loss is stable versus last year at negative 57 million euros. Net finance and tax income expense is reported at negative 0.1 million euros versus negative 42 million euros in the prior year. The lower cost is related to high unrealized exchange losses in the first nine months of the prior year. Total loss for the year reached negative 69 million euros, 30 million less than in the prior year. Finally, we reported cash and cash equivalents at September 30th, 2023 of 171 million euros compared to 289 million euros at the end of December 2022. This position includes an additional $50 million drawdown on the existing credit facility with Deerfield and Orbimed and takes into account significant payments made to Pfizer in relation to the phase three line study, Valor. Now moving on to slide 17 to review our guidance for the fiscal year. We reiterate our guidance for revenues and other income communicated earlier this year. We expect product sales to reach between 130 to 150 million euros and other income to reach between 90 and 110 million euros, assuming a sale of the Chikungunya PRV in the fiscal year 2023. We reduce our guidance on R&D investment to 60 to 70 million euros versus 70 to 90 million euros previously. This concludes the finance section of this call, and I would like to hand back to Thomas for the upcoming catalyst.
spk08: Thank you so much, Peter. Yeah, so this brings me to the point of summarizing really what we have to expect over the course of the coming months. On Chicken Gouda, first of all, and most importantly, the Biduva Action Date with the potential PLA approval by the end of this month. Still on track for that. The adolescents immunogenicity and final safety data for Part A, also still this month. Then the additional two-year antibody persistence data, please be reminded that we reported the one-year follow-up data, the persistence data last December, so therefore we expect also data on the two-year time point in December. And then the ACIP recommendation, um that is still you know planned for february 2024 which of course is critical um for the future potential commercial success of chicken guinea especially travelers and u.s records um online um continued trial execution it's very critical that that we have the enrollment completed for the core tools so that we have all necessary know subject in the study ahead of the 2024 tick season and then the next real catalyst for Lyme will come at the end of tick season 2025 with the readout of the primary endpoint and at least one or two of the first secondary endpoint Additional new flows include the potential granting and sale of the FDA for Health Review Voucher upon approval of VLA553, the initiation of our Zika vaccine development with a new phase 1 start early next year, and further advancement and acceleration of selected preclinical programs. With that, we are concluding that part of the presentation. When we look at the future strategic development of the company, we see really very potential strategic growth opportunity for Valneva. This includes, on the one hand side, maximizing the existing travel vaccines, leveraging continuous recovery of travel to pre-COVID levels and beyond from a volume perspective. Then, of course, the potential label expansion for VLA553 or chikungunya vaccine candidates after initial approval in adults and approvals in all the necessary markets. And as we have said multiple times, we are also looking into opportunities potentially in licensing or partnering or acquiring additional clinical stage assets to leverage our proven and excellent R&D capability. And with that, I would like to conclude our presentation and hand back to the operator to take your questions. Thank you.
spk09: Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. Please stand by as we complete a Q&A roster. Our first question comes from the line of Maury Raycroft of Jefferies. Please go ahead. Your line is open.
spk05: Hi. Thanks for taking my questions, and congrats on the progress. I was going to ask one about chikungunya. So, at the recent October ACIP meeting, the chikungunya committee draft recommended vaccination to adults traveling to outbreak areas. However, they expressed some concern over the size of the safety population to detect rare adverse events, as well as the use of immunogenicity as the endpoint. The post-marketing outbreak study should address both of these points. But I'm wondering if size of the safety population is also something being discussed with FDA heading into the PDUFA. And separately, will the outbreak study being in the works be sufficient ahead of the February ACIP vote? or will ACIP want additional progress or evidence before they make that vote?
spk08: So, Maury, of course, excellent question. So, first of all, the safety database is supporting licensure, and otherwise we would not be where we are at this point in time. Of course, the program is or will be licensed under the Accelerated Approval Pathway. So this means the Accelerated Approval Pathway by definition uses a surrogate and therefore immunogenicity data, there is nothing one can do about it. But of course, we're gonna prove real-world effectiveness as part of the phase four. And of course, there will be also dedicated past studies or safety follow-up once the product is used in a, I would say, larger cohort. And this is all being part of the ongoing discussions and part of the ongoing process with the FDA and will, of course, form the basis for the anticipated licensure. the agreement on phase four protocol and conceptual design is mandatory for licensure and therefore the exact design will be also available to ACRP and as such will also make clear to ACRP what they will and can expect in the years to come around the variance of the chikungunya VLA 1553.
spk05: Got it. That makes sense. So having the study designed for ACIP should be sufficient for them ahead of their vote. This is our current working hypothesis, yes. Okay. Makes sense. Is there any other perspective you can share on interactions with FDA and frequency of interactions ahead of the approval as it relates to the outbreak study and potential label discussions? I just wanted to check if you're saying anything on that.
spk08: No, I think, of course, I mean, you will understand, Murray. You know this business well enough. We can and will not comment on ongoing interactions with the agency. It is fair to say that, of course, as we are now on the, what I say to the team all the time, on the last mile of the marathon, we have very intense and high frequency interactions with the agency as we jointly try to conclude this entire process on time.
spk05: Got it. Makes sense. And maybe last question for me, just for Lyme cohort two, it sounds like enrollment is going well there. When should you have the cohort fully enrolled in order to get the required initial doses for tick season one for that cohort? I guess, is there any perspective on timing that you can share on that?
spk08: So basically, there is not necessarily a hard drop date on all of that. But I think, as you know, we aim to have people fully immunized and having, you know, ideally peak titers optimized against the peak of the tick season. And this gives you a little bit of a perspective given the schedule, 0-2 ticks, and the fact that we see then antibody titers at highest level around month seven. And this gives you a little bit of a prospect. And given that the tick season, yes, has a peak, but there is also the shoulder fraction left and right. So this gives you a little bit of flexibility around that. So into early next year, I would say.
spk05: Got it. Okay. Thanks for taking my questions.
spk09: Thank you. We will now take our next question. Please stand by. Our next question comes from the line of Ed White of HC Wainwright. Please go ahead. Your line is open.
spk10: Good morning. Thanks for taking my questions. So just on the travel market, maybe I can ask a big picture question. And you continue to say you're seeing recovery in the travel market. Can you give us a good comparison on your thoughts for 2024 versus pre-COVID levels? And then also just on Exario, with the $32 million DOD contract, were any sales recorded in this quarter, if you could break that out for us, and also how we should be thinking about the cadence of that contract. Should it be fulfilled by the end of this year, or should we see the impact going into next year as well?
spk08: Thank you. No, I think so. So basically, let me answer the travel market question first. This is a very good question indeed. And as we have said multiple times, when we look at, and Peter reported this also, when we look at volume, because as we have also been able to leverage price increases. We need to look at volume and prepare this to pre-COVID levels. There are countries where it's being sold, where we are indeed back to pre-COVID volume levels already today. There are also countries where we are above pre-COVID volume levels today. And there are other countries where we are not yet at pre-COVID volumes. And there's a lot to do with travel behaviour. Generally, we see a trend towards higher awareness. But it is very difficult to clearly model. I mean, we really do hope that we're going to see next year in the vast majority of countries volumes back or above pre-COVID levels. and this is really the outlook that we're going to take. On the military contract, and I'll let Peter then say something about what sales numbers we have recognized in the military, but generally, the contract with the DoD is a one-year supply contract, and therefore, the supply schedule, and by the way, we have already done first shipments, but the supply schedule is, of course, a supply schedule that spans over one year and not necessarily a fiscal year. And this supply plan is also subject to potential changes, which we continue to respond to upon the request of the DOD.
spk07: Peter, are the numbers? Yeah, maybe just, so we had a first shipment to the U.S. military, indeed, in the third quarter. We have not disclosed the number in this quarter, and as Thomas said, we are actually now aligning with the U.S. military on the supply schedule for the rest of the contract, and we might disclose numbers in the fourth quarter, but so far we haven't done it.
spk10: Okay. Thanks for taking my question.
spk09: Thank you. We will now take our next question. Please stand by. Our next question comes from the line of Evan Wang of Guggenheim Securities. Please go ahead. Your line is open.
spk03: Hey, guys. Happy to see the team and draft recommendation at ASAP. That looks encouraging in our view, particularly with implications for, I guess, both risk-based and exposure risk. That seems to be positive for military use. But interested in hearing your thoughts on the draft recommendation as well as how you're thinking about, you know, the recommendation will look internationally?
spk08: Well, this is a little bit, what you're asking is a little bit crystal ball reading. So first of all, I mean, on a positive note, as you rightly pointed out, ACRP recommended vaccination, right? Which, of course, is already in its draft recommendations. It's great news. They have in the draft included a few caveats to it and defined what really people at risk of chikungunya may mean. But please keep in mind these are draft recommendations and so this is an ongoing process and it should be an ongoing independent process and not something where we are intimately involved. We provide information, we provide the science, we provide the data. But overall, we see this going into the right direction. With regards to other regulatory bodies, other recommendation bodies, I mean, first of all, you know that every single regulatory authority is taking, you know, a slightly different stance when it comes to interpretation of data. So, therefore, I think the basis for potential recommendations may be different in different geographies. On top of that, we have learned, and I personally have learned this through my more than 30 years in the vaccine industry that, you know, also different recommendation bodies take very different approaches. So it's very difficult to predict at this point in time how other regulatory bodies, you know, be it in Canada or be it in Europe or even be it in other territories will position chikungunya. We continue to believe that chikungunya is representing a major unmet medical need. And therefore, we see a benefit to provide a vaccine solution.
spk03: Great. And as a follow-up in terms of the HMPV asset, I know you guys are seeking a partner there. We're seeing a pretty robust initial launch in RSV. It seems like HMPV could be a very interesting program. Can you help us think about, you know, how you're thinking about partnering discussions and, you know, what scope and type of agreements you're looking at? Thanks.
spk08: Yeah. This is also, of course, a very good question. I think, as you have rightly pointed out, I think the RSV market is expected to, you know, transition towards an RSV-HMPV combination market when it comes to vaccination strategies and vaccination solutions, vaccine solutions. And therefore, we decided not to develop HMPV as a standalone clinical asset. Right now we are looking at different partnership opportunities and this spans across a pure straight out licensing all the way into potential other sets of joint development structures and the like. But it is too early at this point in time to guide really what it's going to be. What we can say is we have multiple parties under CDA, and we are exploring opportunities here. Hello?
spk09: Thank you. We will now take our next question. Please stand by. Our next question comes from the line of Simon Scholz of First Berlin. Please go ahead. Your line is open.
spk02: Yes, good afternoon. Congratulations on the strong numbers. I was just wondering if you could let me know which of your planned future chikungunya trials will generate 15-day onset of immunity data for inclusion on the label subject to approval and how soon you might be able to get that data onto the label.
spk08: Yes. So right now, I mean, as you know, when we started the development of chikungunya, we had agreed a standard endpoint, meaning a month after vaccination. Of course, we have already published data that show an early onset. However, this data was generated from earlier studies, and therefore, As soon as we're going to start the next study, and the next study is probably going to be a study in immunocompromised, we will include an earlier immunological endpoint in order to verify what we have seen already in prior studies, namely that we got to have an immunogenicity level above the anticipated protective threshold somewhere in between day eight and day 14. And we will, of course, include that so that we can use this data from a well-controlled phase three study in order to amend the label as soon as possible.
spk02: Okay. Thanks very much.
spk09: Thank you. We will now take our next question. Please stand by. Our next question comes from the line of Samir Devani from RxSecurities. Please go ahead. Your line is open.
spk06: Hi, guys. Thanks for taking my questions. Congrats on a good quarter. Congrats on the ASIP draft recommendation. I've got a few questions. I'll probably kick off on that first. One of the bullets highlights that it's recommended for somebody traveling to a territory where there is a chikungunya outbreak. And I'm just wondering, as we sit today, which territory would you say is the most important that's currently exhibiting a chikungunya outbreak? So I guess that's the first question.
spk08: Samir, excellent question. So I think, first of all, I mean, the question is, is it an area where there has been an outbreak? Or is there an area where there is an actual outbreak? Or is it an area where there might be an outbreak coming up very soon? It is not 100% clear from what has been drafted thus far. And it is also not clear how outbreak is defined. And so basically today, as you know, we have seen outbreak literally in every single country in South America. But we have also seen geographically I would say distinct outbreaks in the southern part of Europe. We have seen it in France, we have seen it in Italy, we have seen it in Spain. So I think this whole definition around outbreak, outbreak risk, I think there is a need for refinement and for precision, I would say. And we hope that this will come as part of the further ACIP process leading then finally to a vote in February, hopefully.
spk06: Is there a resource where a traveler can go online and know if they're going somewhere that there's a chikungunya outbreak?
spk08: In terms of actual outbreak, I mean, the only thing that I'm aware of is that WHO reports generally outbreaks, but also here we have seen different definitions of outbreak. So I'm not aware that there is a real standardized kind of
spk06: information platform but i will be very happily take this as a follow-up action samir and and get back to you on that one okay that's great thanks very much um and then maybe a couple of questions for peter um there's a significant reduction in the refund liabilities on the balance sheet and obviously a significant payment was made in the quarter i'm assuming it looks like there's going to be a similar payment made for Q4, just correct me if I'm wrong on that, and then once that payment's been made, how far are you away from being capped out in terms of your liability to Pfizer?
spk07: Yes, Amir, thanks. Great question, obviously. As we said, when I talked about cash, I did mention that this cash situation at the end of September takes into account significant payments. Now, you see how the refund liability in our balance sheet is reduced. Now, how much we pay in Q4 and thereafter, we have not guided, and so I cannot disclose it, of course, in this call. But we've always said we will be done paying for Lime in the first half year of 2024.
spk06: Okay, great. And then final question, just on the finance expense, Peter, in Q3, specifically Q3, that went up quite a lot. And is that just, I think Preet, you talked about non-euro cash assets, I assume. Is that just a translation effect again in Q3?
spk07: Yeah, that's absolutely correct. It's a translation effect. It's basically the effect between US dollar and euros.
spk06: Okay, that's great. All right, thanks very much.
spk09: Thank you. We will now take our next question. Please stand by. Our next question comes from the line of Max Herman of Stifel. Please go ahead. Your line is open.
spk01: Great. Thanks very much for taking my questions. Three, if I may. Firstly, just on the Chikungunya program. Conceptually, how would you just... I'm trying to get my head around trying to understand this phase four commitment and how would you conduct logistically a... an outbreak study in Chikungunya, given the infrequency and the uncertainty about which region it will be? That's the first question. Second is just on, again, trying to get conceptually about the booster dose with the Lyme disease, VLA-15. Do you think, and do you have any data whether this would be a seasonal booster that you would need or how frequently. I know obviously the trial design requires boosters in the second year, but do you think that is the right way to go forward or where would you need the booster? And then finally, just on Zika, just in terms of reinstigating that program, what was the kind of commercial evaluation that was done in order to, you know, re-instigate that program? What are the metrics you've used to believe that there's a significant commercial opportunity there? Thank you.
spk08: So, a number of good questions. Max, let me start with Chikungunya. I mean, of course, as you rightly pointed out, effectiveness means that you need to provide the vaccine in a country where or in a region where you have either an actual outbreak or where the virus is really prevalent and you see a high chance of an outbreak. This is why we are partnering with Instituto Punatan and CEPI because we believe that the best feasibility for all of that will be Brazil and we are And this is also part of the protocol and it takes into consideration that you have a certain setup ready and that you then go into a real outbreak life situation with the study. On your question around booster, of course, this is a very important question. I mean, you know that the Booster vaccination, as shown in the follow-up studies from phase two, generates a very high anamnestic response with immunogenicity levels significantly, very significantly above priming. So this means whether we will need a booster every year or every other year or every third year or or what it's really going to mean is only this question can only be answered post-efficacy study and once we see hopefully a correlation in between immunogenicity and efficacy and that will then inform what kind of immunological levels need to be reached in order to have a meaningful predictive efficacy And that's why we continue doing the antibody persistence studies with primarily the phase two cohorts to inform us about this situation. On Zika, I would like to remind everyone, so what is really the, and we have been explaining this all along a couple of times. So point number one, is we have decided to reinitiate for two main reasons. Number one is we see an emerging epidemiological development around Zika. You see, for example, in India, Zika cases significantly have arisen. You see also you know, here and there, spot rises on Zika virus prevalence in other countries. And the WHO issued a blueprint and a white paper around the fact that for Zika vaccines, they recommend inactivated whole virus and or recommend protein-based vaccines. given the tolerability profile for vaccines of that class. So that's the reason why we said, let us go into that. We have also said that we're going to monitor the, I would say, the medical or the unmet medical needs, meaning the real development of the epidemiology over the course of next year. We have built certain commercial models, but we need to refine those models. And we said only if there is a continuous development on the medical need side and subsequently a favorable commercial opportunity, we will continue clinical development post the initial phase one. And this we have also publicly disclosed.
spk01: All right. Thanks very much. Just in terms of the field study, just to understand a little bit more, and I know you obviously have been having lots of detailed discussions with the FDA about this, but are you thinking about choosing a region where there have been recurrent chicken infections and then setting up a program there and kind of waiting for... an outbreak or are you looking at some sort of quick response to an outbreak where you can vaccinate the population there?
spk08: In reality, you can think about it. It's almost a combination of the two things that you have just said, but this is the way you can think about it.
spk01: Okay. I appreciate that. Thanks very much.
spk09: Thank you. There are no further questions. Speakers, please continue.
spk04: Well, that concludes our presentation today. Thank you all for your participation. Just note that there will be an archived version of the webcast available on our website later today. Thank you, everybody.
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