Q3 2025 Nyxoah SA Earnings Call

Speaker #1: by. Welcome to the Nyxoah third quarter 2025 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there'll be a question session, you'll need to press star 11 on your and answer session.

Speaker #1: telephone. You will then hear an automated message advising your hand is raised. To withdraw your finished. Please be advised that today's conference is being your speaker today, Pearson Dennis.

Speaker #1: recorded. I would now like to turn the call over to

Speaker #1: ahead.

Speaker #2: Thank you. Good

Speaker #2: afternoon, everyone, and I welcome you to our third quarter 2025 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive

Speaker #2: During the call, we will discuss our operating activities and review our third quarter 2025 financial results released after U.S. Officer, and John Landry, Chief Financial Officer. market closing today.

Speaker #2: During the call, we will discuss our operating activities and review our third quarter 2025 financial results released after U.S. Officer, and John Landry, Chief Financial Officer.

Speaker #2: answer session. The press release can be found on the investor relations section of our website. This call is being recorded which, we will host a question and section on the investor relations tab of our website.

Speaker #2: Before we begin, I would like to clarify that expectations or predictions of future events, market trends, and archived event results or performance are forward-looking statements.

Speaker #2: All forward-looking statements are based upon our current estimates and various assumptions. These forward-looking statements involve material events to materially differ from risks and uncertainties those anticipated or implied by these forward-looking statements.

Speaker #2: statements are based upon current available All forward-looking information. And the company assumes no obligation to update these statements. Accordingly, you should not that could cause actual results or place undue reliance on these forward-looking statements.

Speaker #2: For a list and uncertainties associated with our business, please refer to the risk factors section of our form 20F filed with the Securities and description of the risks and Exchange Commission on March 20th, 2025.

Speaker #2: With that, I will now turn the call over to

Speaker #3: Thank you, Pearson. Good

Speaker #3: day, everyone, and thank you for Olivier. quarter 2025 earnings joining us for the third call. Since at the approval on August 8th, our U.S.

Speaker #3: long GMO have generated strong enthusiasm across the EMP and sleep communities. Physicians welcome the long-awaited optionality now available to their OSA patients and the end of a single solution the recent International Surgical Sleep Society, IEEF meeting, our GMO market.

Speaker #3: case discussions and share perspectives. These discussions reflected what we continue to observe globally. Clinicians value choice in treating obstructive sleep apnea, and our differentiated bilateral patient-centric design resonates strongly with both surgeons and sleep were particularly encouraged by physicians.

Speaker #3: conversations with physicians During familiar with GMO's clinical performance in Europe as well as the We strong clinician results demonstrated in the Dream Study. Many providers highlighted the opportunity to tailor needs, and expressed treatment based on individual patients' appreciation for our approach to chronic disease management.

Speaker #3: Patients' feedback integration and multidisciplinary care pathways. Finally, our first commercial GMO completed as early as implant in the U.S. September, represented an important milestone for our teams and 231,00 0 U.S.

Speaker #3: dollars in revenue. During the third quarter and ahead of our expectations, early surgeons' feedback has emphasized streamlined patient management, closed collaboration between EMTs and sleep physicians, and strong patient follow-up still early, this partners.

Speaker #3: reinforces our confidence that with a compelling new engagement. While alternative. We are navigating the critical steps of early commercialization and the momentum we are Already generating generating in training physicians, committee approvals.

Speaker #3: reinforces our confidence that with a compelling new engagement. While alternative. We are navigating the critical steps of early commercialization and the momentum we are Already generating generating in training physicians, obtaining value analysis And securing coverage for major public and private payers strategy with 25 encouraging.

Speaker #3: Territory managers, we are extremely focused on the initial top 400, 125 of the high-volume hypoglossal nerve sites, representing roughly 75 to 80 percent of the total in our initial launch AGNS volume.

Speaker #3: We are actively tracking a number of leading indicators to measure our early progress. Since launch, until end of October, we can report that out of the 125 targeted accounts, 111 surgeons are already successfully been trained on leading indicator, 102 value analysis committee approvals have been received.

Speaker #3: Reimbursement has which already 35 been secured with Medicare GMO. and 10 private payers Second Shield, and Cigna. 63 prior authorizations were submitted; already. Including United percent success 21 approvals have been already the CPT code 64568 was accepted.

Speaker #3: 15 received, with 100 implants were already successfully performed across nine accounts in the ratio. Beginning In all of these approvals, on the road since the launch and interacting Healthcare, Blue Cross Blue I'm hearing.

Speaker #3: Surgeons are enthusiastic to finally with surgeons, I've been have second AGNS option to offer to their OSA patients. They commented that GMO is unique and differentiated as a solution which incredibly encouraged by feedback resonates very well with patients seeking therapy.

Speaker #3: They highlight the powerful and symmetric tongue protrusion achieved with bilateral stimulation. The report that the GMO procedure is efficient with procedure times up to 60 minutes on average.

Speaker #3: In conclusion, first interaction with GMO was positive; surgeons are excited to incorporate the GMO solution into their daily side, we have made practice. significant On the reimbursement progress.

Speaker #3: Our GMO access program provides dedicated support to our customers for prior authorizations. Each territory manager works with a dedicated case manager who interfaces between the clinical team and patient and sales team.

Speaker #3: The program includes a reimbursement helpline and communication portal for real-time tracking. To date, we have achieved 100 percent approval on all our prior authorization submissions through our GMO access program.

Speaker #3: Including with 10 key private payers such as United Healthcare, Blue Cross Blue Shield, Healthcare Service Corporation, Anthem, and Cigna. In addition, to providing this direct support to our customers, we are also seeing progress with commercial payer policy decisions.

Speaker #3: Healthcare Service Corporation or HCSC operates Blue Cross Blue Shield plans in Illinois, Texas, Oklahoma, New Mexico, and Montana. HCSC and Blue Cross Blue Shield of Michigan have updated their hypoglossal nerve stimulation medical policies to already include CPT code 64568 as a reference procedure code.

Speaker #3: While coverage of hypoglossal nerve stimulation was already established, the inclusion of this code provides additional clarity for providers and payers with the company expects will help reduce administrative barriers and streamline patient access.

Speaker #3: HCSC and BCBS of Michigan represent over 26 million members across six states. We continue engaging with additional commercial payers and expect continued progress on coverage decisions in the coming quarters.

Speaker #3: Looking ahead, our priorities are clear. We will continue expanding our U.S. commercial organization, adding territory managers, deepening coverage of high-volume implanting centers. Training programs are scheduled through year-end with a strong pipeline of surgeons requesting implant slots.

Speaker #3: Beyond the U.S., we are focused on driving deeper penetration in Germany and in the United Kingdom. Where we maintain a strong presence. And in the Middle East, where we hold exclusive status as the only available AGNS solution, while selectively expanding into additional geographies with strong demand for differentiated technology.

Speaker #3: This is an exciting time for Nyxoah. We have the team in place, we have surgeon demand, we have payer coverage, and most importantly, we have patients choosing GMO.

Speaker #3: In the fourth quarter, we are focused on execution, training more surgeons, activating more accounts, and treating more patients. With that, I will now turn the call over to our CFO, John Landry, for a financial update.

Speaker #2: Thank you, Olivier. We recorded revenue of 2 million euros in the third quarter of 2025 compared to 1.3 million in the third quarter of 2024, an increase of 56 percent.

Speaker #2: Gross margin in the third quarter of 2025 was 60.5 percent compared to 62 percent in the third quarter of 2024. Total operating loss for the third quarter of 2025 was 24.4 million euros versus 15 million in the third quarter of 2024.

Speaker #2: This was driven by the acceleration in the company's commercial investments in the U.S. in preparation for post-FDA commercial launch. Our cash position, including cash, cash equivalents, and financial assets, was 22.5 million euros at September 30th, 2025, compared to 43 million euros at June 30th, 2025.

Speaker #2: I'm excited to share, as we announced earlier today, that we've secured up to 77 million dollars of capital to bolster our balance sheet and help drive the commercialization of GMO in the U.S.

Speaker #2: This financing includes a private placement of equity of approximately 25 million dollars which included existing strategic investors Cochlear and ResMed as well as our chairman and management team members.

Speaker #2: It also includes a convertible bond which can provide us with up to 52 million dollars in two tranches. With the first tranche of 26 million dollars available upon closing of the convertible note.

Speaker #2: The second equally sized tranche can be drawn down at the company's discretion for the 30 days starting seven months after the closing of the transaction.

Speaker #2: We believe the proceeds of this transaction in conjunction with currently available capital provide us with cash runway into the first quarter of 2027. For the fourth quarter of 2025, we expect global revenue to be between 3.4 million euros and 3.6 million euros.

Speaker #2: With that, I'll now turn it back over to Olivier for some closing

Speaker #1: Thank you, John. As we close, I want to remind everyone what truly defines Nyxoah. The future of sleep medicine will be defined by those companies who understand and continuously learn from their patients.

Speaker #1: With GMO, we are not treating sleep apnea as a one-time event. We are managing a chronic condition. Our system learns from every breath, every night, turning data into insights and insights into better outcomes.

Speaker #1: We will be integrating the power of AI and self-learning in our next generation of GMO. Developing a therapy that adapts, evolves, and becomes more personal over time.

Speaker #1: It's not just about features of a device. It's about creating an ecosystem that empowers patients, physicians, and healthcare payers to manage sleep apnea smarter, simpler, and more sustainable.

Speaker #1: At Nyxoah, everything we do starts and ends with the patient. We will continue to empower them to effectively manage their OSA through our technology.

Speaker #1: We believe that our focus on innovation, supported by clinical evidence, drives progress. And that the winners will be the patients who finally get their night back through good sleep quality.

Speaker #1: And at Nyxoah, we are excited that we can finally offer this to patients in the United States. With that, I would now like to open the lines

Speaker #1: for Q&A. Thank you,

Speaker #3: ladies and gentlemen. If you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star 11 again.

Speaker #3: We'll pause for a moment while we compile our Q&A roster. Our first question comes from Ross Osborne with Cantor Fitzgerald. Your line is open.

Speaker #4: Hey guys, congrats on the progress. Excited to see the U.S. launch going well right off the bat. And thanks for taking our questions. So maybe starting off, and you know, more on the qualitative side, could you provide some feedback that you're hearing from docs as well as their patients on why they're choosing GMO versus other

Speaker #4: options? Yeah, you know, definitely also thank

Speaker #1: you for the question. So first of all, as I was mentioning, physicians are extremely excited that they have optionality. So that today they can offer their patients the GMO solution as well.

Speaker #1: And this is resonating extremely strong. Second thing that we are hearing as well that is always coming out is the fact that we offer a bilateral stimulation solution that is really respecting the anatomy of the hypoglossal nerve.

Speaker #1: And that is also resulting in an option to treat patients also with more complex airway obstructions. So those are the two main things that keep coming back and that you're hearing first.

Speaker #4: Okay, great. And then lastly, and apologies if I missed this, where do you stand on your Salesforce build-out?

Speaker #1: So as I was already earlier communicating, so we do a focused launch on the top 400 implant accounts in the U.S., so the high-volume AGNS sites.

Speaker #1: With our current Salesforce, we are covering the first 125 out of these 400. We will further scale by adding every quarter up to 15 territory managers that would represent them and other 75 implant sites.

Speaker #1: So if you do a little bit of calculation behind, after four quarters, we would be able to cover all under 400 high-volume implant sites even a little bit further and we would end up with a Salesforce of 85 people.

Speaker #4: Great. Thanks for taking our questions, and congrats on

Speaker #4: the progress. Thank

Speaker #3: One moment for our next you. question. Our next question comes from Adam Meter with Piper Stanley. Your line is open.

Speaker #5: Hi, good afternoon. Thank you for taking the questions and congrats on U.S. launch. A couple from me, if that's okay. And maybe just to start, Olivier, I think I had a bad connection.

Speaker #5: So I just wanted to double-check the number of implants that were done in the U.S. in Q3. Can you just give us that number again as well as the U.S.

Speaker #5: revenue in

Speaker #5: Q3?

Speaker #1: definitely. So we did 15 implants, spread over nine different accounts, and they were all done in the month of September. And we did 200 31,000 euros in

Speaker #1: revenue. So Okay, perfect. So just to be clear, Adam, that 15 was through the end of October. Sorry about that. 15 was through the end of October.

Speaker #1: And the two 31 was through the end of September for euro denominated revenue.

Speaker #4: I got it. Okay. That's helpful. And then I guess just, you know, kind of a related question, but as we think about models for Q4 and U.S.

Speaker #4: launch, appreciate, John, you gave us, you know, 3.4 to 3.6 million euro outlook for the overall business. Any finer point you want to put on U.S.

Speaker #4: versus OU.S. at this

Speaker #4: point? Yeah, I appreciate the question,

Speaker #1: Adam. You know, at this point, we're not going to break out the U.S. versus international in terms of guidance. We're still in the early phases here of the account activation ramp in the U.S.

Speaker #1: the continued acceleration of U.S. And that Q4 guidance really reflects implants as more accounts complete back approvals and prior authorizations. More surgeons are trained and we also see sustained growth in both Germany and the

Speaker #1: UK. Okay.

Speaker #4: Understood. And just one last one, if I may. Olivier, if I heard correctly, did you say the device is going to become potentially more proximal over time?

Speaker #4: Did I catch that remark correctly? And if so, you know, maybe just walk us through the appeal of going proximal versus distal. Thanks.

Speaker #1: Adam, I think you must have misheard this because I never talked about proximal versus going more distal when it comes to the use of our device.

Speaker #1: So I want to be very specific on this. We have our specific positioning where we place the panels on the nerve. And that is also very well patented.

Speaker #1: If I can refer to this, or if it's very clear that there are no changes at all that we are making. So maybe what you heard was when we were talking about the next generation that we are developing of the product, where, of course, we keep putting the patient at the center. We are talking about integrating self-learning into our device, becoming smaller and more autonomous so that patients also can get more control over their own technology.

Speaker #4: Okay. Thanks for clarifying, Olivier. Apologies about

Speaker #4: that. Thank you. No problem.

Speaker #1: No

Speaker #1: problem, Adam. One

Speaker #3: One moment for our next question. Our next question comes from Suresh Khalid with Oppenheimer. Your line is open.

Speaker #5: Hi, Olivier, John, can you hear me all right?

Speaker #1: Yes, thank you. Hi, nice hearing you,

Speaker #1: Suresh. Perfect.

Speaker #5: Hey, Olivier, I'll ask both my questions together. And pardon the background noise. I'm in an airport. So Olivier, of the current implants, admittedly they're very relatively a smaller quantity, right?

Speaker #5: Can you give us an idea of where the initial appeal is? Is it women? Is it CCC? Is it a lack of ICG pockets?

Speaker #5: Is it supine, non-supine? You know, again, with this initial cohort of implants, have you all seen any pull-through specifically in one category? And if I could just also lump in my second question quickly, Olivier, of the 100 plus sites that you're targeting, I appreciate you walking us through in terms of CBD codes and whatnot.

Speaker #5: That are getting through prior authorization. Olivier, how is GEO being slotted from a logistical perspective? Because most sites of these high-volume sites have these quote-unquote inspired days, right?

Speaker #5: And obviously the push is on to ramp up inspired five and put more. And is GEO slotted on inspired days or are you all seeing a separate at least from a logistical perspective?

Speaker #5: Gentlemen, thank you for taking my questions and congrats on the progress.

Speaker #1: It looks like one has completed and canceled because it was quite a long question and clear point at the sound quality wasn't as good as I would hope it to be.

Speaker #1: So first of all, I do want to emphasize how with GEO we are totally differentiated from a place pacemaker platform and technology. And this is also determining the choice of physicians.

Speaker #1: So I think the first part of the question was why GEO? And then who is using GEO and what is about female, male, and further differentiation?

Speaker #1: I do think that it's clear what we are seeing is that it's a real combination of male and female. So it's not that our technology is only beholden to treat one or the other.

Speaker #1: It's clear that it appeals very well to both males and females. What we're also seeing is that the average age is quite young.

Speaker #1: I mean, and young defined as 52 to 54 years old. And also people who are really consciously working with their health in the sense that they do value the power of not needing resurgery when a battery is depleted.

Speaker #1: Not needing resurgery to benefit from the latest and greatest software upgrades. And they embrace also the implant for life concept, knowing that once an implant is done, they are protected, regardless of what sleep position they are, they are protected, ed, regardless is the airway obstruction a little bit more complex.

Speaker #1: So this I would like to point out. Second, I was hearing also the CCC aspect in your question. It is clear that in our label, CCC is not a contraindication.

Speaker #1: It's under the warning, but it's also not yet on label because we're waiting for the access study data outcome, where we closed enrollment and what we expect to show next year around this period. We need to do a 12-month follow-up.

Speaker #1: So CCC is not contraindicated. It's under the warning and it can be chosen for a physician at physician's discretion, but it's not on label.

Speaker #1: So I want to be very clear on this. And then last, when we also talk about GEO and compare to also the logistics in the hospitals, so once we are working through the VAC committee, it's clear that we see that in the high-volume accounts, of course we break the monopoly that is currently there by giving options for choice.

Speaker #1: And we're also hearing through market research very encouraging signs that physicians are seeing this as becoming a market where it will end up in a 50-50 split or even with some playing out in our favor.

Speaker #1: So a lot of enthusiasm with clear differentiation versus pacemaker. A clear differentiation in patients choosing the implant for life. Approach with no need for resurgery going forward.

Speaker #1: And no differentiation between male, female. It's at this moment based on the numbers and the experience we build in the US, we see that both are really benefiting and then choosing for GEO.

Speaker #1: I hope that answers your

Speaker #1: question.

Speaker #5: Thank

Speaker #5: you. One moment for our next

Speaker #3: question. Our next question comes from John Block with Steeple. Your line is open.

Speaker #4: Thanks, guys. And good afternoon. John, maybe the first one for you. Just to level set, as we build out and refine our models, are these the KPIs that you're going to be providing on a quarterly sort of consistent basis?

Speaker #4: In other words, should we be focusing on the number of surgeons trained, the number of accounts that have implanted, the VAC figures? Is that the expectation that these will be the metrics and transparency with it every three months or so?

Speaker #4: For the short term, John, yes. I think over the short term, maybe the near-term, mid-term will provide these metrics as we become a more material revenue generator.

Speaker #4: We'll likely drop one of them, potentially the value analysis committee packages. They're submitted, and we'll probably do that. We'll obviously continue to provide updates on reimbursement and surgeons trained.

Speaker #4: But I think the one that over time will probably drop is value analysis committees. So we want to give everybody a sense as to the progress we're making based on these KPIs.

Speaker #4: And then as we become a revenue generator, we'll evaluate these going forward.

Speaker #5: Okay. That's helpful. And the second one is sort of a two-parter. Maybe the first one because we were sort of flip-flopping between September and October.

Speaker #5: So September, John, 231,000 euros implies, I don't know, 10 to 11 US implants in the month of September. And then is the number of implants total 15 through October?

Speaker #5: Do I have that correct?

Speaker #4: Yes, 15 implants. We're done through the end of October. Correct.

Speaker #5: Okay. So maybe you just want to talk about why the number of implants is going to get cut in half from September to October.

Speaker #5: Maybe that's just a stocking dynamic and how they go out to the facilities, but help us out there, please. And Olivier, more of a high-level question for you.

Speaker #5: I'm just curious, as you take a step back, and obviously you've been waiting for the U.S. launch for quite some time now. What was the biggest surprise in your view?

Speaker #5: From the US launch over the past couple of months? Thanks for your time.

Speaker #6: Yeah. Thank you, John, for the questions. I think I can handle part one and part two because they are a little bit late to each other.

Speaker #6: So when you say what was the biggest surprise, I never thought that we would advance so fast from a surgeon training all the way to a surgeon implant and knowing that we in between we had to get a VAC approval and we get to have a pre-authorization submission followed by a pre-authorization approval by a payer before we could do an implant.

Speaker #6: So that was, for me, a very positive surprise that we can move fast, and we see that we are continuing to move fast. And then the first part of the question, I think, is related to this.

Speaker #6: So if you see, and then why didn't we do more implants in this time frame? It has simply to do with the fact that we see on average when there is a pre-authorization submitted, it takes like two weeks to obtain an approval.

Speaker #6: Once you have an approval, it takes another two weeks before you generate revenue. So in total, we are talking about roughly four weeks. So if we then start looking when we did the submissions, because they are depending on the VAC committee approvals, that is also the phasing and then that will be answering the question why not more implants were done yet in the month of September and October.

Speaker #6: Although I would like to remind everyone that the sales team is doing extremely great and if you can say that you already have nine centers where active implants took place in seven weeks post-approval, I think this is a very encouraging result and I want to applaud my team for this.

Speaker #3: Thank you. One moment for our next question. Our final question comes from David Rescott with Baird. Your line is open.

Speaker #7: Great. Thanks for taking that launch. I wanted to follow up question, Steven. Congrats on the on a made relative couple points you to the Q4 guide.

Speaker #7: First, on pricing, I believe the math again based on the 10 to 12 implants or so in the quarter versus the reported US 25 grand ASP.

Speaker #7: number, So just wanted to confirm that that on a US dollar basis puts you at that 20 to was correct. And when we think about this number for Q4, again, we can see October and so that puts a bigger number in timeframe.

Speaker #7: number, So just wanted to confirm that that on a US dollar basis puts you at that 20 to was correct. And when we think about this number for Q4, again, we can see October and so that puts a bigger number in what's been done in So how do we think about that kind of November, December cadence to hit what this implied guide is for Q4, assuming that this step up is more based on the US the November, December

Speaker #7: number?

Speaker #4: Yeah. Sure, David. Thank you. Thanks for the

Speaker #4: question. So from a average selling price perspective, we're right in the zip code of 25,000 from an average selling price for our implants. There's not a one-for-one correlation with the revenue that's booked.

Speaker #4: We have, as we do in Europe, we defer a small piece of the revenue when we ship because we spread out the disposable exactly shipments over the course of the year.

Speaker #4: So the portion that we spread out over time. So there's that delta and then in terms of the guide, we don't necessarily, we're not breaking out US to three, four, and three, six.

Speaker #4: versus international here for the fourth quarter to get our number of cases we've done in October, as we look ahead to where we're going for cases that need to be performed in the months of November and December and in order to fulfill that demand for those cases, we would expect our US revenue to grow from October to November and then from But as we look at So that's how we're thinking about it.

Speaker #4: The visibility into the number in the remaining 60-ish days of the quarter here.

Speaker #7: Okay. That's helpful. I guess on more of the P&L side, I think gross margins

Speaker #7: were in the low 60s this quarter.

Speaker #7: rollout is impacting November again to December. that. But maybe can you give us a sense for into the fourth of cases that we're expecting here 2026, how we should be thinking about this contribution from the gross margin line as you scale up and more broadly

Speaker #4: Sure. the US rollout, maybe impacting Absolutely. So as we think about

Speaker #4: gross margins, long-term, we have an opportunity to get a gross margin into the 80% range. rollout? And I think it's really

Speaker #4: get there. One is we have our next-generation Genio 2.2, which will enhance the patient Thank you. experience. From an activation ship perspective, as well as disposable patch perspective, we're also significantly reduced the cost.

Speaker #4: So that's more of a tail-end in 26, early 27, but that'll be a meaningful step up in gross margin. From there, the other item is in terms of volume, as we scale our production volumes of our implant, we have different volume breakpoints in our contract manufacturing agreement.

Speaker #4: So as we drive volume, we'll see those continue to reduce over time. And then just overall working through supply chain and logistics as we're in the early stages of that right now and as those systems mature and we work through the flow of goods throughout the entire supply chain channel, that'll help be the final leg of the stool to get us up that 80-plus percent gross margin range so in the near term, i.e., fourth quarter of this year and 26, probably not many drivers in the way of moving gross margin up from where we are today.

Speaker #4: I'd expect that more towards tail-end of 26 going into 27.

Speaker #7: Okay. Perfect. Thank

Speaker #7: you. You're

Speaker #3: And pardon Mrs. Ockham, welcome. the operator. We did have some just a recently queue up. Did you want to go ahead and take that question?

Speaker #4: Yes.

Speaker #3: Okay. One

Speaker #3: moment. Our next question comes from Paige Chamberlain with Wolf Research. Your line is open.

Speaker #8: Hi guys. Good afternoon. Thank you for taking the questions and squeezing me in. I just have a couple on reimbursement. I appreciate the updates and the prepared remarks there.

Speaker #8: I guess ahead, I'm just wondering if you can help us frame how to think about the phasing of unlocking wider spread reimbursement in the US and how that progress should flow into our build of the US commercial ramp.

Speaker #8: And second question, I'll lump it in here on a similar note. Obviously, there have been some changes in moving parts around coding in the HGNS space, 64568 is the code you guys are using now.

Speaker #8: I'm wondering if that is still the code that is intended to be used in the long term. Thanks so much.

Speaker #4: Thank you. Thank you. And also, refreshing me in a new voice on during the analyst call. So thank you for the question on reimbursement.

Speaker #4: So first of all, to your point, the CPT code 64568, which is a recognized code by Medicare for OSA indication, it is the same code used currently for AGNS therapy being Genio or being the alternative therapy.

Speaker #4: And it's providing a clear pathway for reimbursement with both Medicare and also commercial payers. So in going forward, we do think that this will be the coding that will be further used and since we are only launching since August 8th, that is also the only code that we are using and have been using because it is the code that fits best also our technology and we're also now seeing that this is the coding also where the latest innovation is used for AGNS.

Speaker #4: So for us, this was a big win. Because we knew also that this was still a question that could only be answered once you submit a reimbursement file and you also actually receive payment and it's of course very rewarding for us to see that we did not only receive payment through Medicare but also through private payers as I was mentioning.

Speaker #4: Yeah. And I'd really like to point out and recognize our market access team that's doing a tremendous amount of work and doing a great job with our Genio access program to help work through this initial process.

Speaker #4: And I think the HDSC and Blue Cross Blue Shield of Michigan where we have 64568 is a reference procedure code. I think that's just sort of the start of it.

Speaker #4: I think over time, we'll have more and more of these payers included the 64568. It's a reference procedure code which will help facilitate the process.

Speaker #4: I think the thing that's very encouraging to us to see right now is that from a cycle time perspective, from a pre-authorization perspective, we're seeing roughly a two business week cycle time from the time of submission to approvals.

Speaker #4: And then on the back end, once the implants are done, we're seeing another two-week cycle time roughly for the facilities and physicians to get paid.

Speaker #4: So it's been pretty consistent and we're really very excited about that. And looking forward to seeing that continue. And And maybe to close on this one, as well if you see and look at the future of this going forward.

Speaker #4: So sometimes it's nice to be second because there was a lot of work done already and I think AGNS is already extremely well recognized through payer.

Speaker #4: So we do not need to do the work or have a listing with every single payer step by step because they are familiar with AGNS and what it can do in the treatment of moderate to severe

Speaker #4: OSA. Thank you.

Speaker #3: I'm not showing any further questions at this time. I'd like to turn the call back over to Olivier for any further comments.

Speaker #3: remarks. I would like to thank everyone for

Speaker #4: participating. Thank you for the good questions. As I was mentioning before, it's the most exciting time for the company. We've all been waiting and working hard to get through FDA approval.

Speaker #4: We obtained it, and now our focus is on launching, continuing to launch, opening more sites, treating more patients. This is, in fact, why we are in this business and what we want to do after this solution—to seriously impact patients' lives.

Speaker #4: So thank you and good afternoon, good evening, everyone.

Q3 2025 Nyxoah SA Earnings Call

Demo

Nyxoah

Earnings

Q3 2025 Nyxoah SA Earnings Call

NYXH

Thursday, November 13th, 2025 at 9:30 PM

Transcript

No Transcript Available

No transcript data is available for this event yet. Transcripts typically become available shortly after an earnings call ends.

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