Valneva SE (NASDAQ:VALN) Q3 2022 Earnings Call Transcript

So which means we will and are conducting studies in additional younger age groups. And this is €“ and one of the very important studies is the study that we are currently conducting in Brazil through our partner Butantan. And this data is expected to complement and change or just the label from a U.S. perspective. We also expect that this data that we generate in Brazil will be filed together with the existing package so that we may have broader labels right from the start in terms of age group. All the other studies that I mentioned on the slide, for example, co-vaccination studies, all and the like are voluntary studies. So these are studies that are not required from a regulatory perspective, but may provide us with additional data to potentially further differentiate and further increase potential uptake on the vaccine in the future.

And those are, for example, co-vaccination studies. Then of course you have for every vaccine, we have the typical post-licensure Phase 4 commitments in our case an infield effectiveness study that is of course a regulatory requirement post-licensure, which will be conducted.

Evan Wang: Great. And then can you talk about some of the competitive dynamics in the market? I think there are other trials ongoing I think that expected first half next year. I guess in terms of the 2024 HCIP, are you expecting multiple vaccines to be discussed at this point? And can you talk about how you’re thinking about kind of competitive dynamics? Thanks.

Thomas Lingelbach: Very good question. So let me start with the latter part first. We do not expect that at the FDA pre-meeting other chikungunya vaccines will be ready for discussion. So at this point in time as you know, there is only one additional program in Phase 3 in the €œwestern world€. And this program is in two Phase 3 studies, to our knowledge one study that for which, enrollment completion was just recently announced and another study to complement the upper age range for which to our knowledge recruitment is still ongoing. So we expect with regards to competition, with regards to licensure to be well ahead of any competition.

Evan Wang: Great. Thanks, guys.

Operator: Thank you. One moment for our next question. Our next question will come from the line of Max Herrmann from Stifel. Your line is open.

Max Herrmann: Hi. It’s Max Herrmann here from Stifel. Thanks very much for taking my questions. A few of them may. Firstly, just wanted to understand a little bit about comment about completion of recruitment of the VLA15 study, the VALOR study in Q2. If you are recruiting or completing recruitment at that stage, will that enable you to recruit all the patients in time for the €“ season for the 2023 Lyme disease season? That’s my first question.

Thomas Lingelbach: Yes. So basically Max, first of all, hi, and very good question. You know, that the season starts in March, April and goes all the way until September, depending on the area €“ September, October. So of course and the second quarter is long, right? So it’s not €“ it doesn’t necessarily say that we are recruiting till the end of the second quarter. But basically of course, we are anticipating that we are doing the enrollment as quickly as possible so that we can get the 100% of the anticipated people into the first season.

Max Herrmann: Because obviously you’ve got a six month period vaccination period to get the three doses in and so even if you start in April, you’ll only just be finishing that those patients that will finally in April, in October timeframe.

Thomas Lingelbach: You will have a number of patients that you will only catch toward the end of the season.