Good day, and thank you for standing by. Welcome to the Nyxoah Third Quarter 2025 Earnings Conference Call. Please be advised that today's conference is being recorded. I would now like to turn the call over to your speaker today, Pearson Dennis. Please go ahead.

Thank you. Good afternoon, everyone, and I welcome you to our third quarter 2025 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our third quarter 2025 financial results released after U.S. market closing today, after which we will host a question-and-answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section on the Investor Relations tab of our website. Before we begin, I'd like to remind you that any statements that relate to expectations or predictions of future events, market trends, results or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these forward-looking statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F filed with the Securities and Exchange Commission on March 20, 2025. With that, I will now turn the call over to Olivier.

Thank you, Pearson. Good day, everyone, and thank you for joining us for the third quarter 2025 earnings call. Since FDA approval on August 8, our U.S. launch activities following FDA approval of Genio have generated strong enthusiasm across the ENT and sleep communities. Physicians welcome the long-awaited optionality now available to their OSA patients and the end of a single solution market. During the recent International Surgical Sleep Society, ISSS meeting, our Genio Symposium and educational event drew a full room of clinicians eager to engage with real-world 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 physicians. We were particularly encouraged by conversations with physicians familiar with Genio's clinical performance in Europe, as well as the strong clinician results demonstrated in the DREAM study. Many providers highlighted the opportunity to tailor treatment based on individual patient needs and expressed appreciation for our approach to chronic disease management, patient feedback integration, and multidisciplinary care pathways. Finally, our first commercial Genio implant in the U.S. completed as early as September represented an important milestone for our teams and partners, already generating USD 231,000 in revenue during the third quarter and ahead of our expectations. Early surgeon feedback has emphasized streamlined patient management, close collaboration between ENTs and sleep physicians, and strong patient follow-up engagement. While still early, this reinforces our confidence that Genio is well positioned to serve U.S. OSA patients with a compelling new alternative. We are navigating the critical steps of early commercialization, and the momentum we are generating in training physicians, obtaining value analysis committee approvals, and securing coverage from major public and private payers is extremely encouraging. In our initial launch strategy with 25 territory managers, we are focused on the initial 125 of the top 400 high-volume hypoglossal nerve sites, representing roughly 75% to 80% of the total HGNS volume. 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 have already successfully been trained on Genio. Second leading indicator, 102 value analysis committee submissions have been completed, of which already 35 approvals have been received. Reimbursement has been secured with Medicare and 10 private payers already, including UnitedHealthcare, Blue Cross Blue Shield, and Cigna. 63 prior authorizations were submitted, 21 approvals have been already received with a 100% success ratio. In all of these approvals, the CPT Code 64568 was accepted. 15 implants were already successfully performed across 9 accounts in the first 12 weeks. Beginning on the road since the launch and interacting with surgeons, I've been incredibly encouraged by the feedback I'm hearing. Surgeons are enthusiastic to finally have a second HGNS option to offer to their OSA patients. They commented that Genio is unique and differentiated as a solution, which resonates very well with patients seeking therapy. They highlight the powerful and symmetric tongue protrusion achieved with bilateral stimulation. They report that the Genio procedure is efficient with procedure times up to 60 minutes on average. In conclusion, first interactions with Genio were positive. Surgeons are excited to incorporate the Genio solution into their daily practice. On the reimbursement side, we have made significant progress. Our Genio 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, patient, and sales team. The program includes a reimbursement outline and communication portal for real-time tracking. To date, we have achieved 100% approval on all our prior authorization submissions through our Genio Access Program, including with 10 key private payers such as UnitedHealthcare, Blue Cross Blue Shield, Health Care 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. Health Care 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 the hypoglossal nerve stimulation medical policies to already include CPT Code 64568 as a reference procedure code. While coverage of hypoglossal nerve stimulation was already established, the inclusion of this code provides additional clarity for providers and payers, which the company expects will help reduce administrative barriers and streamline patient access. HCSC and BCBS of Michigan represent over 26 million members across 6 states. We continue engaging with additional commercial payers and expect continued progress on coverage decisions in the coming quarters. Looking ahead, our priorities are clear. We will continue expanding our U.S. commercial organization, adding territory managers to deepen coverage of high-volume implanting centers. Training programs are scheduled through year-end with a strong pipeline of surgeons requesting implant slots. 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, we hold exclusive status as the only available HGNS solution while selectively expanding into additional geographies with strong demand for differentiated technology. 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 Genio. 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.

Thank you, Olivier. We recorded revenue of EUR 2 million in the third quarter of 2025 compared to EUR 1.3 million in the third quarter of 2024, an increase of 56%. Gross margin in the third quarter of 2025 was 60.5% compared to 62% in the third quarter of 2024. Total operating loss for the third quarter of 2025 was EUR 24.4 million versus EUR 15 million in the third quarter of 2024. This was driven by the acceleration in the company's commercial investments in the U.S. in preparation for the post-FDA commercial launch. Our cash position, including cash, cash equivalents, and financial assets was EUR 22.5 million at September 30, 2025, compared to EUR 43 million at June 30, 2025. I'm excited to share, as we announced earlier today, that we secured up to $77 million of capital to bolster our balance sheet and help drive the commercialization of Genio in the U.S. This financing includes a private placement of equity of approximately $25 million, which included existing strategic investors, Cochlear and ResMed as well as our Chairman and management team members. It also includes a convertible bond, which can provide us with up to $52 million in 2 tranches, with the first tranche of $26 million available upon closing of the convertible note. The second equally sized tranche can be drawn down at the company's discretion for the 30 days starting 7 months after the closing of the transaction. We believe the proceeds of this transaction in conjunction with currently available capital provides us with cash runway into the first quarter of 2027. For the fourth quarter of 2025, we expect global revenue to be between EUR 3.4 million and EUR 3.6 million. With that, I'll now turn it back over to Olivier for some closing remarks.

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 for their patients. With Genio, 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. We will be integrating the power of AI and self-learning in our next generation of Genio, developing a therapy that adapts, evolves, and becomes more personal over time. It's not just about features of a device; it’s about creating an ecosystem that empowers patients, physicians, and health care payers to manage sleep apnea smarter, simpler, and more sustainably. At Nyxoah, everything we do starts and ends with the patient, and we will continue to empower them to effectively manage their OSA through our technology. 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. 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 for Q&A.

Our first question comes from Ross Osborn with Cantor Fitzgerald.

Congrats on the progress. Excited to see the U.S. launch going well right off the bat. So maybe starting off and 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 Genio versus other options?

Definitely, Ross, thank 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 Genio solution as well, and this is resonating extremely strongly. 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 expecting the anatomy of the hypoglossal nerve and that is also resulting in an option to treat patients also with more complex airway obstructions. So those are the 2 main things that keep coming back and that you are hearing first.

Okay. Great. And then lastly, and apologies if I missed this, where do you stand on your sales force build-out?

So as I was already earlier communicating, we do a focused launch on the top 400 implant accounts in the U.S., so the high-volume HGNS sites. With our current sales force, 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 another 75 implant sites. So if you do a little bit calculation behind after 4 quarters, we would be able to cover all of these 400 high-volume implant sites. Speed a little bit further, and we will end up with a sales force of 85 people.

Our next question comes from Adam Maeder with Piper Sandler.

Congrats on U.S. launch. A couple for me, if that's okay. And maybe just to start, Olivier, I think I had a bad connection. 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. revenue in Q3?

Yes, definitely. So we did 15 implants spread over 9 different accounts, and they were all done in the month of September. And we did EUR 231,000 in revenue.

Just to be clear, Adam, that 15 was through the end of October. Sorry about that. 15 was through the end of October. And the EUR 231,000 was through the end of September for euro-denominated revenue.

I got it. Okay. And then I guess just kind of a related question. But as we think about models for Q4 and U.S. launch, I appreciate, John, you gave us EUR 3.4 million to EUR 3.6 million outlook for the overall business. Any finer point you want to put on U.S. versus OUS at this point?

Yes. I appreciate the question, Adam. 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. And that Q4 guidance really reflects the continued acceleration of U.S. implants as more accounts complete VAC approvals and prior authorizations, more surgeons are trained and we also see sustained growth in both Germany and the U.K.

Okay. 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? Did I catch that remark correctly? And if so, maybe just walk us through the appeal of going proximal versus distal?

Adam, I think you must have misheard it because I never talked about proximal versus going more distal when it comes to the use of our device. So I want to be very specific on this. We have a specific positioning where we place the pedals on the nerve, and that is also very well adapted, if I can refer to this. So 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 product, where, of course, we keep putting the patient at the center, and then we are talking about integrating self-learning into our device, becoming smarter and more autonomous so that patients also can get more control over their technology.

Our next question comes from Suraj Kalia with Oppenheimer.

Olivier, John, can you hear me all right?

Yes. Nice to hear you, Suraj.

Perfect. Olivier, I'll ask both my questions together and apologize for the background noise as I'm at the airport. Regarding the current implants, they are admittedly a smaller quantity. Can you give us an idea of where the initial interest lies? Is it among women, CCC, or is it due to the lack of IPG target? Is it related to supine or non-supine usage? With this initial group of implants, have you observed any specific pull-through in one category? Additionally, of the 100-plus sites you are targeting, I appreciate your insights on the CPT codes and the prior authorization process. How is Genio being integrated from a logistical standpoint? Most of these high-volume sites have 'Inspire Days,' and there's a push to ramp up Inspire V. Is Genio scheduled on those Inspire Days, or is it being handled separately from a logistical perspective? Congrats on the progress.

I will try to answer as completely as I can, Suraj, because it was quite a long question, and to your point, the sound quality wasn't as good as I would hope it to be. So first of all, I do want to emphasize how with Genio, we are totally differentiated from a pacemaker platform technology. And this is also determining the choice of physicians. So I think the first part of the question was why Genio and who is using Genio and what is about female, male, and further differentiation. 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 revolved to treat one or the other. It's clear that it applies and appeals very well with both male and female. What we're also seeing is that the average age is quite young. I mean, 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, not needing resurgery to benefit from the latest integrated 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 regardless if the airway obstruction is a little bit more complex. 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. It's under the warning, but it's also not yet on label because that's where we are waiting for the ACCCESS study data outcome where we closed enrollment and what we expect to show next year around this period because we need to do a 12-month follow-up. So CCC is not contraindicated; it's under the warning, and it can be chosen for a physician at physician discretion, but it's not on label. So I want to be very clear on this. And then last, when we also talk about Genio and compared to 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 are breaking the monopoly that is currently there by giving options of choice. And we're also hearing through market research, a very encouraging sign that physicians are seeing this as becoming a market where it will end up in a 50-50 or even with some maybe playing out in our favor. So a lot of enthusiasm, a clear differentiation versus pacemaker, a clear differentiation in patients choosing the implant for life approach with no need for resurgery going forward and no differentiation between male and female. It's at this moment, based on the numbers and the experience we built in the U.S., we see that both are really benefiting and choosing Genio. I hope that answers your question.

Our next question comes from Jon Block with Stifel.

John, maybe the first one for you. Just to level set, like 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? 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 3 months or so?

For the short term, Jon, yes. I think over the short term, maybe in the near term, midterm, we'll provide these metrics. As we become a more material revenue generator, we'll probably likely drop one of them, potentially the value analysis committee packages that are submitted. We'll probably do that. We'll obviously continue to provide updates on reimbursement and surgeons trained. But I think the one that over time will probably drop is value analysis committee. So we want to give everybody a sense as to the progress we're making based on these KPIs. And then as we become a revenue generator, we'll evaluate these going forward.

Okay. And the second one is sort of a 2-parter. Maybe the first one, because we were sort of flip-flopping between September and October. So September, John, EUR 231,000 implies, I don't know, 10 to 11 U.S. implants in the month of September. And then is the number of implants total 15 through October? Do I have that correct?

Yes, 15 implants were done through the end of October. Correct.

Okay. So maybe you just want to talk about why the number of implants sort of got cut in half from September to October. 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. 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 from the U.S. launch over the past couple of months?

Yes. No, thank you, Jon, for the questions. And I think I can handle part 1 and part 2 because they're a little bit linked to each other. 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, knowing that in between we had to get the VAC approval and we had to have a preauthorization submission followed by a preauthorization approval by the payer before we could do an implant. 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 it is related to this. So if you see - and 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 preauthorization submitted, it takes like 2 weeks to obtain an approval. Once you have an approval, it takes another 2 weeks before we generate revenue. So in total, we're talking about roughly 4 weeks. So if we then start looking at 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? Although I would like to remind everyone that the sales team is doing extremely great. If you can say that we already have 9 centers where active implants took place in 7 weeks post-approval, I think this is a very encouraging result, and I want to applaud my team for this.

Our final question comes from David Rescott with Baird.

Congrats on the launch. I wanted to follow up on a couple of points you made relative to the Q4 guide. First, on pricing, I believe the math again, based on the 10 to 12 implants or so in the quarter versus the reported U.S. number puts you at that $20,000 to $25,000 ASP. So just wanted to confirm that, that on a U.S. dollar basis was correct. And when we think about this number for Q4, again, we can see what's been done in October. And so that puts a bigger number in the November-December timeframe. So how do we think about that kind of November-December cadence to hit what this implied guide is for Q4, assuming that the step-up is more based on the U.S. number?

Yes, sure, David. Thank you. Thanks for the question. So from an 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 exactly one-for-one correlation with the revenue that's booked. We have, as we do in Europe, we defer a small piece of the revenue when we ship because we spread out the disposable shipments over the course of the year. So a portion of it that we spread out over time. So there's that delta. And then in terms of the guide, we aren't necessarily — we're not breaking out U.S. versus international here for the fourth quarter to get to EUR 3.4 million to EUR 3.6 million. But as we look at 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 in order to fulfill that demand for those cases, we would expect our U.S. revenue to grow from October to November and then from November again to December. So that's how we're thinking about it and get the visibility into the number of cases that we expect here in the remaining 60-ish days of the quarter.

Okay. I guess on more of the P&L side, I think gross margins were in the low 60s this quarter. I'm guessing some of the rollout is impacting that. But maybe can you give us a sense for, into the fourth quarter, into 2026, how we should be thinking about this contribution from the U.S. rollout maybe impacting the gross margin line as you scale up and more broadly roll out?

Sure, absolutely. So as we think about gross margins, long term, we have an opportunity to get our gross margins into the 80% range. And I think it's really a multipoint program to get there. One is we have our next-generation Genio 2.2, which will enhance the patient experience from an activation ship perspective as well as a disposable patch perspective but also significantly reduce the cost. So that's more of a tailwind in '26, early '27, but that will 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. 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. As those systems mature and we work through the flow of goods throughout the entire supply chain channel, that will help be the final leg of the stool to get us up to that 80-plus percent gross margin range. So in the near term, i.e., fourth quarter this year and '26, probably not many drivers in the way of moving gross margin up from where we are today. I'd expect that more towards the tail end of '26 going into '27.

And pardon, this is Kevin, the operator. We did have some just recently queue up. Did you want to go ahead and take that question?

Yes.

Our next question comes from Paige Chamberlain with Wolfe Research.

I just have a couple on reimbursement. I appreciate the updates in the prepared remarks there. 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 U.S. and how that progress should flow into our build of the U.S. commercial ramp? And second question, I'll lump it in here. On a similar note, obviously, there have been some changes and moving parts around coding in the HGNS space, 64568 is the code you guys are using now. I'm wondering if that is still the code that is intended to be used in the long term.

Thank you. And also refreshing hearing a new voice during the analyst call. So thank you for the question on reimbursement. 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 HGNS therapy being Genio or being the alternative therapy, and it's providing a clear pathway for reimbursement with both Medicare but also commercial payers. So going forward, we do think that this will be the coding that will be further used. And since we are only launching since August 8, that is also the only code that we are using and have been using because it's 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 HGNS. 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.

Yes. And I'd really like to point out and recognize our market access team is doing a tremendous amount of work and doing a great job with our Genio Access Program to help work through this initial process. And I think the HCSC and Blue Cross Blue Shield of Michigan, where we have 64568 as a reference procedure code, I think that's just sort of the start of it. I think over time, we'll have more and more of these payers included, including the 64568. It's a reference procedure code, which will help facilitate the process. I think the thing that's very encouraging to us to see right now is that from a cycle time perspective, from a preauthorization perspective, we're seeing roughly a 2 business week cycle time from the time of submission to approvals. And then on the back end, once the implants are done, we're seeing another 2-week cycle time roughly for the facilities and physicians to get paid. So it's been pretty consistent, and we're really very excited about that and look forward to seeing that continue.

And maybe to close on this one as well, if you see and look at the future of Nyxoah going forward. Sometimes it's nice to be second because there was a lot of work done already, and I think HGNS is already extremely well recognized through payers. So we do not need to do the heavy lifting with every single payer step by step because they are familiar with HGNS and what it can do in the treatment of moderate to severe OSA.

I'm not showing any further questions at this time. I'd like to turn the call back over to Olivier for any further remarks.

I would like to thank everyone for participating. Thank you for the good questions. As I was mentioning before, it's the most exciting time for the company. We have been waiting and working hard to get to FDA approval. We obtained it, and our focus is launching, continue launching, opening more sites, treating more patients. And this is, in fact, why we were in this business and what we want to do: offer this solution to seriously impact patients' lives. So thank you, and good afternoon, good evening, everyone.

Ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.