Nyxoah S.A. (NASDAQ:NYXH) Q3 2023 Earnings Call Transcript

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Olivier Taelman: Yes. So let me start with, first with some facts. So in the ACCESS study, that protocol [indiscernible] up to 40 sites that were implanted, although we do not anticipate activating that many, we have so far activated four sites, but we can go up to 40. That’s that one. Second fact is that we are feeling comfortable that we will close the enrollment by the end of 2024. Everything is going in this direction. So it’s trending really in a positive way. Now another fact is that in the ACCCESS study of BMI — the patient’s BMI cannot be above 35. I think this is important, as I already was commenting earlier, we believe, and we see this in clinical literature that to have an optimal therapeutic effect from HGNS, a patient should not be having a BMI that is higher than 35.

What we also learned in this that patients suffering from CCC and also the correlation with their BMI is present. So we see that we have a lot of patients with the BMI somewhere in the range of 30 to 35. Now what you can expect is that there are also quite some patients with a BMI above 35 that are suffering from CCC. And that is precisely where we are seeing a very positive impact from GLP-1s because — and if you speak to KOLs, what we did extensively, we’re also hearing there, but it’s clear that lower the BMI that is above 35, bring the patient in the range of 30 to 35 implant with HGNS and have a successful therapeutic response. Physicians are more behind that concept than increasing of implanting patients with a BMI above 35. And where there is a risk that there will be not a strong therapeutic response.

So I’m welcoming mostly the GLP-1 impact too low and to bring those really obese patients into this range below 35%. And then regardless, if they suffer from CCC or non-CCC, with Genio, we know that we can offer them a successful therapeutic solution.

Operator: Our next question comes from Ross Osborn with Cantor Fitzgerald.

Ross Osborn: In terms of commercialization activities outside of Germany, would you provide an update on how Spain is receiving your system following first implants this summer? Additionally, I would be curious to hear what other countries you had implants in during the quarter, in addition to Italy? And where we should be thinking about for the balance of this year and 2024?

Olivier Taelman: Yes. So to your point, so today, we are reimbursed in Spain, in Switzerland and also, of course, in Germany, where we generate like 95% of our revenue. And going forward, we did first Italy, because in Italy, in order to obtain reimbursement, there was a demand for country-specific data, and that’s why we did the first patients already. We are going up to 10 patients in Italy. And then based on these data, we will submit them together with the existing data. And hopefully, this will result also in a reimbursement in Italy. In the Nordic countries, same thing goes for Finland. So there we did some implants already. And based on these data, we are trying to secure hospital reimbursement hospital by hospital, and also we generate more commercial implants in Finland.

And what I was mentioning earlier on, I think a very important market will be the U.K. First step to enter the U.K. is to being allowed by NHS to participate in a tender. We have received this official communication that we are. Now the next steps will be how to compete in this tender and how to make our case strong, so we can enter. So that’s in a nutshell where we are and where you can expect us to be reimbursed shortly.

Operator: Thank you very much for your questions. I am showing no further questions at this time. Thank you for your participation in today’s conference. This does conclude the program. Enjoy your evening. And you may now disconnect.

Olivier Taelman: Thank you.

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