Valneva SE

given that there was a competitive vaccine which was acquired by a private company who kind of talked about expanding global registrations of that vaccine. I was just wondering if you could discuss your thoughts on the market and how you are kind of able to defend your position there. Thanks.

So let me take a second question and then I will give to the first part to Peter. So, look, I mean, at this point in time, we have not seen any competitor for JE initiating the necessary clinical studies for a registration in Europe and US. And there is no way, you know, you can register this competitive product without a respective clinical study. And those will, you know, take time. And I think we got to deal with it when we see, you know, a potential competitor entry. In terms of positioning, our vaccine has more than 10 years history. It is a vaccine that is marked by excellent effectiveness and safety. And it is a very well-known and established brand. And as such, we feel strong about this product. We feel strong about its prospects. And we would also feel strong about it if we had a competitor interest. which is not on the horizon at this point in time from where we stand at this point. Peter, you want to say something about guidance?

Yeah, well, thanks, Rachon, for the question. Look, I think we're very optimistic when it comes to our sales. I think, as you said, with a very strong first quarter, actually in line with pre-pandemic level in Euro terms. So, of course, this is great for the rest of the year. Also, and as Thomas said, we still have some supply constraints in Q1 So we're very optimistic with regards to reaching our guidance. Whether it will be the upper part of the guidance, I think it's too early to tell, but we're certainly at a good start.

Thank you. Thank you.

Once again, if you would like to ask a question, please press star 1 and 1 on your telephone keypad. We will now take your next question. And your next question comes from the line of Samir Devani, RX Securities. Please go ahead.

Hi, guys. Thanks for taking my questions. I think I've got a couple. Just going back to the successful mid-cycle review, Thomas, I just wanted to get whether you got any more colour as to whether there was likely to be a VIRPAC meeting or not. I guess that's the first question. And then the second one is really just on... the Pfizer-Lyme collaboration, you haven't booked any or recognised any revenue in the P&L this quarter. So I was just wondering if you could help us understand whether we should still expect you to recognise anything for the remainder of the year. And if so, what sort of magnitude? And also, I think in the last call, you talked about your contribution coming out of refund liabilities. There doesn't seem to be much change in your refund liabilities on the balance sheet. Could you just confirm whether there's been a significant payment made during the quarter for that R&D contribution. Thanks.

Okay, so, Samir, again, mid-cycle review, we have not mentioned anything about a VRBPAC, and we have not mentioned anything about any ROPOC. This should be giving you the right answer, I think. And then on the regular recognition contribution liabilities, I hand over to Peter and his team.

Yeah, thank you. Hey, Samir. So on the revenue recognition, you're right. We have not recognized any revenue. There could still be going forward some revenue that we could recognize potentially, which we've decided not to do so far as long as the phase three trial is still you know, in the relatively early stage and ongoing. But we certainly have some amounts that we could potentially recognize going forward. I think on the refund liability, I think your observation is very good. So there was, I think, with the overall situation of the LIME, I think there were some, I would say, delays in issuing invoicing. So we indeed have not paid as much In Q1, we would have dissipated, and that's why probably you haven't seen a lot of movement in the refund liability. So there will be a catch-up in the later part of the year, but it doesn't change the overall cost base we had estimated earlier on.

Okay, that's very helpful. And then maybe I should just sneak in one more. Just on your third-party product sales, they were quite a lot lower than what they were in Q4. Could you just... Explain to us what's going on there and what we should expect for the rest of the year. Thanks.

Yeah, look, as I said before, I think when I look at it, we're in Euro terms in line with where we were pre-pandemic. So I think it's a very strong quarter. I think it's in line with our expectations. And we're optimistic for the rest of the year to deliver product sales within guidance, 130 to 150 million euros. Okay, that's great. Thank you very much.

Thank you. We'll now go to your next question. And your next question comes from the line of Simon Scholes, First Berlin. Please go ahead, your line is open.

Yes, hello, I've got two questions. I remember in the last call you were discussing that a more creative solution with the FDA might have allowed you to submit documentation already as early as 2025, despite the loss of trial participants. And I'd just be very curious if you could discuss what that creative solution might have entailed. And secondly, can you give us any indication, I mean, can you tell us whether you expect the supply constraints which hit the travel vaccine business in Q1 to ease in the current quarter? Thanks.

So, first of all, not so sure whether I recall having said created. I think you did. But yeah, well, I mean, as I mentioned, I answered the same question earlier on, right? I think we have evaluated the possibility to take special subcalls earlier. But after a careful risk benefit evaluation, we have decided that it is not in the interest of this program. um to um to increase its its risk profile um and that's why we have said we keep the original protocol as is um on the supply constraint side of things um you know yes we have um had supply issues uh in still in the first half of the year because demand has just exceeded um what we had anticipated um and you know we have a long lead time to produce the vaccines and when we saw last year that there was a big beginning recovery um we immediately started um but it takes time so we are currently anticipating no further supply constraints going forward from where we are today okay thanks very much thank you

There are currently no further questions. I will hand the call back to you.

I think with that, we would like to thank you for your participation today. Thank you for your support and for following Balneva. It's been a pleasure to provide you today's update. Have a good remainder of the day. Bye-bye.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.