Nyxoah S.A. (NASDAQ:NYXH) Q4 2023 Earnings Call Transcript

Olivier Taelman: Thank you, Ross, for the question. I mean, we are thinking and we are preparing a lot of different strategies on this point, but I can really be precise in the answer. So the U.S. market today is very concentrated. We plan a targeted launch focused on top accounts, which constitute over 85% of current HGNS sales in the U.S. We will have a dedicated sales force sized appropriately for a targeted launch. There will be targeted DTC focus on product differentiation and patient referral pathway. I think this will be a main differentiator to what is happening today. It will be really a targeted DTC focus. We will be engaging with sleep specialists, enabling a steady stream of patient referrals, scalable patient follow-up strategy and sales, marketing and private authorization teams ahead of launch, and more details I’m really happy to share later this year.

Ross Osborn: Okay. Great. And then maybe one more qualifying question on the ResMed partnership. Would you just remind us why they are incentivized to market Genio?

Olivier Taelman: Yes. So in fact, I — first of all, I would like to maybe — partnership because through this partnership, we really aim both ResMed and Nyxoah and our patient centric approach, developing a complete OSA ecosystem where patients can be guided to whichever OSA treatment best suits their needs. We will collaborate on DTC initiatives, sales and marketing efforts to target both sleep physicians and ENT surgeons. And I think the goal of this partnership or to expand OSA therapy penetration and increase of market share. Now what are the benefits? I think for Nyxoah, it’s pretty obvious that having access to patients who are quitting CPAP that can be offered Genio, this will drive share gains and strengthen our relationship with sleep specialists.

For ResMed, benefit from having access to more OSA patients through the ENT surgeons that we are having at Nyxoah also or helpline and increasing sleep specialist capacity by sending CPAP struggling patients who are time consuming to Genio. I think something also not to neglect is the healthcare system benefit, as untreated OSA patients are at high cost, ensuring these patients are optimally treated either with CPAP or with Genio will definitely have a positive impact on reducing healthcare spendings. And overall, this partnership will also increase OSA therapy penetration and will benefit patients.

Operator: Thank you. One moment for our next question, please. And it’s from the line of David Rescott with Baird. Please proceed.

David Rescott: Great. Thanks for taking the questions. I know you touched a little bit on the reimbursement landscape in the U.S. again, I know you mentioned that September of last year at AAO there was some discussions around new codes. Can you remind us what specifically are the next steps as you look out over the next several quarters or so around what we’ll find out and when we’re going to kind of find that update out around what a U.S. reimbursement code would look?

Olivier Taelman: Yes. No, no, definitely. So the next step will be very precise that the AAO will make a recommendation on CPT code to AMA. So from our side, we are working immediately to secure reimbursement from both CMS once we have FDA approval, so that we can immediately start commercializing. And in parallel, of course, preparing also commercial payers and educate and train them on products can also convince them to start reimbursing our technology. Now, our competitor, as you know has done a terrific job educating the commercial payers about the benefits of HGNS resulting in all having HGNS coverage policies. We have already engaged in an informal discussion with the payers and expect those policies. At launch, very precise, we anticipate being reimbursed to prior authorizations and would expect to be included in coverage policies with commercial payers within 12 months afterwards.

David Rescott: Okay. And then, you mentioned some investments in the sales force ahead of the U.S. launch. I heard you also mention some investments in manufacturing. I’m curious what specifically is going on from the manufacturing side? And historically I think you talked about this $4 million of quarterly cash burn. Is that kind of the right way to think about that into 2024? Or should there be some type of acceleration assuming that you continue to invest in some of the sales force and manufacturing capabilities ahead of a U.S. launch? Thank you.

Olivier Taelman: Yes. So, first part is on the manufacturing side, we really invested heavily. So we have now a complete approved site in Belgium manufacturing our products. And next to this, we are working with a service provider in the U.S. that will also manufacturing or will also manufacture our products. So with both sides, we do believe that we totally or completely have de-risked the manufacturing volume capacity, that we will be able to start building inventory before launch. So that at all time when we launch, we will have significant inventory in our possession that there will never be a product shortage in the first 12 months of launch. That is one thing. When it comes to the cost relating to this and the overall spend, Loïc, I’m sure that you would like to comment on this a little bit further.

Loïc Moreau: So you have seen that we burnt €4.9 million in the last quarter of 2023. When we look forward, we expect the burn rate to remain steady for the first half of the year, while we are in fact doing our pre-commercial investments and then when we starting this summer, we expect this burn rate to accelerate as we see more and more investments in U.S. commercialization activities.

Operator: Thank you. One moment for our next question, please. And it’s from the line of Adam Maeder with Piper Sandler. Please proceed.

Adam Maeder: Hi, good afternoon. Congrats on the nice finish for the year and the recent progress. And thank you for taking the questions. I wanted to start on the DREAM study and just the disclosure strategy around full DREAM results. So I heard the data should be communicated by early April. Olivier, are you able to talk a little bit more about exactly what’s going to be shared at that point in time? Is it simply the top-line information? Will we get additional details? I’m assuming it’s going to be messaged in the form of a press release, but maybe just talk about disclosure strategy. And then I have a follow-up. Thank you.