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

Thomas Lingelbach: Hi, Samir. So let me start with the COVID question and then I will give the floor to Peter who can explain again, how we are €“ how our payment with regards to our lion share to the Phase 3 works following the last amendment that we did with Pfizer. So on the inventory, yes, you’re absolutely right. We previously confirmed 8 million to 10 million doses. This is absolutely correct. We have this inventory in our warehouses and we have at this point in time, no confirmed orders above and beyond EC and the existing Bahrain orders. But as I said, we are active right now in seeking regulatory approvals in territories where we feel that there is a demand and where we have ongoing discussions with regards to potentially deploying that inventory. And we will, of course, as something like that materializes immediately inform the markets. With that Peter, you may want to explain how our lion cost contributions work and why it’s 2022-2023.

Peter Buhler: Yes, of course. Thanks. Samir, well, basically the way the Pfizer amendment works is that we pay 40% of the total cost, but our 40% are front loaded. So essentially almost all the €“ all our contribution will be paid during 2022 and 2023. There might be a small residual amount kicking in later, but basically after the end of 2023 it will be Pfizer covering their 60% of the total cost, and we will not have any further cash out. So that’s how it works. And I just also take advantage to remind you that what we pay to Pfizer is basically going against our balance sheet so it goes against our contract liability and not through the P&L.

Samir Devani: Okay. That’s very helpful. And maybe just on clarification, the EC contract and the Bahrain contract, do they have €“ is there any sales anticipated from either of those contracts in 2023?

Thomas Lingelbach: There might be small amount related to the Bahrain contract but not to the EC contract.

Samir Devani: Okay. That’s very helpful. Thanks very much.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Evan Wang from Guggenheim Partners. Your line is open.

Evan Wang: Hi. Thanks for taking my question. Can you help €“ first question I have is on 1553. Can you help understand some of the additional trials or analysis that could open additional opportunities, I guess in settings like military, pediatrics, stock time opportunities. Are there additional trials needed to kind of conduct and any kind of timelines or expectations we can think there? And then I have a follow up.

Thomas Lingelbach: Okay, good. So yes, so let me remind you about the overall development program for chikungunya. So conducted two pivotal Phase 3 trials, one the Phase 3 immunogenicity trial to determine safety and effectiveness of the vaccine in adults above 18 years of age and alongside with that clinical lot to lot consistency study also needed for licensure. So with these two studies, we expect the vaccine to be approved in the United States for everyone above 18 years of age. There is no additional study required to support the €“ let’s say, the market launch in all the segments that you have mentioned from a U.S. perspective. Of course, we want this vaccine to be available for everyone about probably two years of age.