Thomas Lingelbach: Loud and clear.
Damien Choplain: Yes, yes. Thank you for taking my questions. First on Zika, please. So, why do you need to conduct a new Phase 1? Why don’t you directly move to – into Phase 2 trial? First question. And what would be the market potential for this vaccine?
Thomas Lingelbach: Yes. So, let me start to expand a little bit what we’re going to do. So, basically, what we – in the Phase 1 study, we saw very nice immunogenicity data. We saw very good safety data. But we did not reach immunological plateau, so which means, we have not yet with the formulation that we used in the Phase 1 study, maximized the potential of the vaccine. So, hence, what we’re going to do here is, we’re going to update the formulation of the vaccine. We’re also going to bring it onto the platform that we further enhanced for VLA2001, because we want to have the platform advantage, and by the end of the day, we want to have a highly differentiated vaccine. We want to have an inactivated vaccine that is going to be best-in-class and therefore, we decided, we could have done a kind of a hybrid Phase 1/2 thing, but we decided that it’s better to go for a new Phase 1 protocol, which in reality is a quite a large Phase 1 protocol, but technically it’s a Phase 1 protocol.
With regards to market size, it is very difficult to quantify at this point in time. And this is also the reason for why we clearly articulated in our H1 report that we’re going to have another review time-point on Zika at the end of the next clinical study. There is clearly a huge unmet medical need and we see again, emerging outbreaks around Zika, but for outbreak diseases, it is not trivial to really quantify the market potential and we need to understand three things. Number one, we need to understand, will we be able to deliver a best-in-class vaccine. And you remember that our inactivated approach here follows really WHO guidance, who clearly ruled out certain other technologies for a vaccine that will target vaccination of women in childbearing age and/or pregnant women in an outbreak situation.
And the second part is really, we need to understand what is the potential under the – under a normal kind of travel sector’s view. And thirdly, is there a possibility to enter into respective partnerships which could help improving the overall financials around it, as we did for Chikungunya with our partnership with CEPI. All that will be further evaluated as we go along. For the time being, as I said, we see a huge unmet medical need. We see the opportunity that Valneva could provide a best-in-class vaccine solution and a vaccine solution that complies fully with the expectations of the medical and scientific community. More, we have to see when we need to decide you know whether – on the basis of data, whether we would proceed then or not.
Damien Choplain: Maybe just a quick one on your guidance. Can you just confirm that you – it still includes the sale of the potential – PRV in 2023, despite the fact that the approval of the chik vaccine has been delayed?
Peter Buhler: Yes. Yes, Damien. Thanks for the question. Yes, indeed it still includes the – under other income, we expect – the expected proceeds from the PRV, despite the fact that the PDUFA date is now a bit later.
Damien Choplain: Okay. Thanks.
Operator: We are now going to proceed with our next question. And the questions come from the line of Evan Wang from Guggenheim Securities. Please ask your question.
Evan Wang: Hi, guys. Thanks for taking the question. Two from me. First on Lyme. Just with the update, the ongoing trial, I know it’s in the hands of Pfizer, but you know, interested here, you know, what the companies are seeing in terms of, you know, incident rate of cases, and you know, Lyme serotypes, both in the Europe and U.S., is it kind of consistent with what you guys are expecting? And second on chikungunya, you know, happy to see some of the durability data showed, or the earlier time point data showed. I was just wondering if there is thoughts on including maybe a subset of patients in either the Phase 4 or other studies to maybe evaluate an earlier time point titer in a larger patient population. Thanks.
Thomas Lingelbach: Yes. Both excellent questions. Let me start with the second one first, because it’s one of the questions that for reasons that you perfectly understand, we are getting all the time onset of immunity. I mean, as I said, we were the first ones to develop the vaccine. We agreed at the time with the authorities on the readout at day 29. Of course, we have a bunch of datasets as we presented today that clearly indicates that the vaccine has a full onset above the seroresponse level very early on. We will – and I mentioned this during my presentation, include those earlier time points as part of studies that we are initiating, be it under Phase 3 or under Phase 4 protocol for sure. And there is absolutely no reason for us not to do this, and there is absolutely no reason to believe that we should not have a fantastic onset of immunity above seroresponse level early on.
So, on Lyme itself, Pfizer conducted an EP study in Europe and the U.S. before the Phase 3 study got even initiated. There have been partial disclosures around the results from this EP study at different conferences. Overall, this EP study confirmed the distribution of the different serotypes on the both sides of the Atlantic that we presented at different occasions and that has been – that can be found in literature within reason I would say, and within you know, variabilities but overall no surprises on that front. With regards to the overall case count, that is of course being monitored at this point in time. There’s nothing we can say. But also, the EP studies confirm the overall incidence rates that has been used to also power the study.
So, so far so good. I would say, everything is working as expected and we have – and Pfizer has no issues in attracting and precluding the respective target population into the study.
Evan Wang: Thanks, guys.
Operator: [Operator Instructions] Thank you. We are now going to proceed with our next question. And the questions come from the line of Suzanne Van Voorthuizen from VLK. Please go ahead with your question.
Suzanne Van Voorthuizen: Hi there. Good afternoon, team. A couple of questions from my side. To start off with the product sales that are growing quite nicely again, can you remind us what the seasonality is that we could – should keep in mind for IXIARO and DUKORAL? Which quarters are typically stronger given the travel patterns and what to expect for chikungunya over time? And then I have a follow-up.
Thomas Lingelbach: Yes. Excellent question. So, I would say, basically, if you look at prior years, you typically see a dip during the summer time. You’ll see higher uptake earlier in the year and later in the year. This has to do with the travel pattern to Southeast Asia. You see a seasonality pattern also for DUKORAL given that the single largest market for DUKORAL is Canada and you see typically a strong, strong demand early on in the year. So, at the end of the year, early on in the year, Canadians like to travel to warmer regions when it’s cold in Canada. So, basically, this is something that we have seen in prior years. It is extremely difficult to model it precisely because we have seen, I would say, variabilities across the years.
But overall, there is a model that we have in place that kind of mimics the seasonality and which of course we also use when we prepare our, you know, year-end projections and latest estimates. But as I said, that’s the reason for why we have said we stick entirely to guidance. With regards to chikungunya and your question about seasonality, chikungunya, that’s an excellent one too. So, I would say, we have slightly different, I would say, territories for chikungunya as compared to Japanese encephalitis, some are the same, some are very different, and so, there are – our current hypothesis is that they will probably kind of balance each other out. So, we are currently not necessarily modeling yet a strong seasonality profile around chikungunya, but of course, when you are pioneering in a brand new indication with brand new vaccines, you learn along the way.
But that’s our current hypothesis.
Suzanne Van Voorthuizen: Got it. Okay. That’s very helpful. And then maybe continuing on the chik vaccine, you started to invest a little bit in preparation for the launch. Can you remind us what gross margin you believe is feasible on this product and how we should look at your sales and marketing expenses for the launch and the long-term run rate?
