Q2 2024 Nyxoah SA Earnings Call
Operator: The press release can be found in the Investor Relations section of our website.
Operator: With that, I'm pleased to turn the call over to our CFO, Loic Moreau, who will provide a financial update.
Olivier Taelman: Now other things, to your point, where we see the European experience showing our ability to take shares. Just as a reminder, we had 27% of the German market share for the second year of the launch. I think that is also something that exceeded our expectations. 9 out of the 10 German accounts are implanting Genio, and we estimate that we will go a minimum above 30%, and in some of those top centers, you are even the market leader after 24 months.
Olivier Taelman: So that is also a very concrete learning that is giving us confidence for the US launch. But if you look at, and we feel that it's more accurate, look at our performance in the first half of the year, where we were still up by almost 30% versus the first half. So I do think overall we are pleased with what we see in Germany. We will take the lessons learned, helping us prepare for a successful U.S. launch.
Operator: It comes from the line of Edward White with H.C. Wainwright.
Operator: Thank you. Thank you. One moment for our next question, which comes from the line of John Block with Stiesel.
Jonathan Block: So, first of all, let me start by saying that competition is good for a market.
Olivier Taelman: Yes, definitely. So, to your point, we have a molar PMA. You know that after you submit the fourth and final module, there is a 180 days time clock that is currently activated. I can already share that there is a lot of activity from FDA, and we have had very positive engagements with them so far. And if you then do the simple math, we should be good to have FDA approval by the end of 2024.
Olivier Taelman: So, we are still very confident that this will happen. However, I want to be a little bit prudent in the sense that I'm not controlling the FDA timeline completely. So, that's why sometimes we're also mentioning up to early 2025. But if you just stick to the math, we see the interaction, all the work has been done, the files have been submitted, everything interactive, reviews ongoing, and site visits taking place. So, we are very confident that by the end of this year, we could have FDA approval.
Olivier Taelman: And what really, really gave me great confidence is just seeing the high number of spontaneous applications that we are getting. And I do not want to, I mean, start throwing in numbers, but there are really a high number of people reaching out that want to be part of it.
Operator: Thank you all.
Olivier Taelman: Out of this number, we will be focusing on 150 from the beginning. We will be doing this in a scalable way, meaning with our 15 sails up in quarter one off launch, they will go after the first.
James: Hi, this is James on behalf of Adam. Thanks for taking the question.
Operator: I wanted to give you guys the opportunity to comment on the Surmount OSA study that was recently released at ADA. We're just curious to get your reactions to that data and if there's been any change to how you guys are thinking about GLP-1s and the impact on your business. Thanks.
Operator: Thank you. As I see no further questions in the queue, I will conclude the session and conference for today. Thank you all who participated, and you may now disconnect.