Good day, and thank you for standing 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-and-answer session. To ask a question during the session, you'll need to press star one-one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one-one again. Please be advised that today's conference is being recorded. I will now extend 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 20th, 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 8th, 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 pivotal study. Many providers highlighted the opportunity to tailor treatment based on individual patients' 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 $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 for 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%-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 sites that 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 United HealthCare, Blue Cross Blue Shield, and Cigna. 63 prioritizations 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 nine accounts in the first four weeks. Beginning on the road since the launch and interacting with surgeons, I've been incredibly encouraged by 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 interaction with Genio was 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 helpline 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 United HealthCare, 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 their 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 Blue Cross Blue Shield 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. 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, where 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 post-FDA commercial launch. Our cash position, including cash, cash equivalents, and financial assets, was EUR 22.5 million at September 30th, 2025, compared to EUR 43 million at June 30th, 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 two 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 seven months after the closing of the transaction. 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 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 from 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 healthcare 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's back through good sleep quality. 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. Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star one one on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star one one again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Ross Osborn with Cantor Fitzgerald. Your line is open. 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. 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? Yeah, no, definitely. Also, thank you for the question. 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 strong. The 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, and that is also resulting in an option to treat patients also with more complex airway obstructions. Those are the two main things that keep coming back and that you're hearing first. Okay, great. Lastly, and apologies if I missed this, where do you stand on your sales force build-out? 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 them and over 75 implant sites. If you do a little bit of calculation behind, after four quarters, we would be able to cover all of the 400 high-volume implant sites, even a little bit further, and we would end up with a sales force of 85 people. Great. Thanks for taking our questions and congrats on the progress. Thank you. One moment for our next question. Our next question comes from Adam Maeder with Piper Sandler. Your line is open. Hi, good afternoon. Thank you for taking the questions and congrats on U.S. launch. A couple from me, if that's okay. 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. We did 15 implants spread over nine different accounts, and they were all done in the month of September. We did EUR 231,000 in revenue. Okay. So just to be clear, Adam, that 15 was through the end of October. Sorry about that. The 15 was through the end of October, and the EUR 231 was through the end of September for Euro denominated revenue. I got it. Okay, that's helpful. And then I guess just kind of a related question, but as we think about models for Q4 and U.S. launch, appreciate, John, you gave us a EUR 3.4 million-EUR 3.6 million outlook for the overall business. Any finer point you want to put on U.S. versus OUS at this point? Yeah, 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. That Q4 guidance really reflects the continued acceleration of U.S. 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 U.K. Okay, understood. 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? If so, maybe just walk us through the appeal of going proximal versus distal. Thanks. 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. 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. If I can refer to this, it is very clear that there are no changes at all that we are making. 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 smaller and more autonomous so that patients also can get more control about their own technology. Okay, thanks for clarifying, Olivier. Apologies about that. Thank you. No problem. No problem, Adam. One moment for our next question. Our next question comes from Suraj Kalia with Oppenheimer. Your line is open. Hi, Olivier, John, can you hear me all right? Yes, thank you. Hi, nice evening to you, Suraj. Perfect. Hey, Olivier, I'll ask all of my questions together. And pardon the background noise, I'm at an airport. So Olivier, of the current implants, admittedly, they're relatively a smaller quantity, right? Can you give us an idea of where the initial appe3al is? Is it women? Is it CCC? Is it lack of ICG pockets? Is it supine, non-supine? 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+ sites that you all are targeting, I appreciate you walking us through in terms of CVV codes and whatnot that are getting through prior authors. Olivier, how is Genio being slotted from a logistical perspective? Because most sites of these high-volume sites have these quote-unquote Inspire days, right? Obviously, the push is on to ramp up Inspire V and put more. Is Genio slotted on Inspire days, or are you all seeing this separate, at least from a logistical perspective? Gentlemen, thank you for taking my questions, and congrats on the progress. I would like to emphasize completely that I can't surprise because it was quite a long question on to your point, and the sound quality wasn't as good as I would hope it to be. 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. I think the first part of the question was, why Genio, and then who is using Genio, and what is it 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. It's not that our technology is only, I really, to treat one or the other. It's clear that it applies and appeals very well with both males and females. What we're also seeing is that the average age, it's quite young. I mean, and young defined as 52-54 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 and greatest software upgrades. 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. 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. It is also not yet on label because that is 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 is under the warning, and it can be chosen for a physician at physician's discretion, but it is not on label. I want to be very clear on this. Last, when we also talk about Genio and compare to also the logistics in the hospitals, once we are working through the VAC committees, it is 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. We're also hearing through market research very encouraging sounds that physicians are seeing this as becoming a market where it will end up in a 50/50 or even with some may play out in our favor. A lot of enthusiasm, a clear differentiation versus pacemakers, a clear differentiation in patients choosing the implant for life approach with no need for resurgery going forward, and no differentiation between male, female. It's at this moment based on the numbers and the experience we build in the U.S., we see that both are really benefiting and choosing for Genio. I hope that answers your question. Thank you. One moment for our next question. Our next question comes from Jon Block with Stifel. Your line is open. 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? 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? For the short term, Jon, yes. I think over the short term, maybe 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. I think the one that over time will probably drop is value analysis committees. We want to give everybody a sense as to the progress we're making based on these KPIs. As we become a revenue generator, we'll evaluate these going forward. Okay, that's helpful. The second one is sort of a two-parter. Maybe the first one, because we were sort of flip-flopping between September and October. September, John, EUR 231,000 implies, I don't know, 10-11 U.S. implants in the month of September. 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. Maybe you just want to talk about why the number of implants sort of get cut in half from September to October. Maybe that's just a stocking dynamic in how they go out to the facilities, but help us out there, please. 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? Thanks for your time. Yeah. No, thank you, Jon, for the questions. I think I can handle part one and part two because they are a little bit linked to each other. 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 in between we had to get a VAC approval and we got to have a pre-authorization submission followed by a pre-authorization approval by a payer before we could do an implant. That was, for me, a very positive surprise that we can move fast and we see that we are continuing moving fast. The first part of the question, I think it is related to this. If you see, and why did not 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. Once you have an approval, it takes another two weeks before you generate revenue. In total, we are talking about roughly four weeks. If we then start looking when we did the submissions because they are depending on the VAC committee approvals, that is also the failing, and then that will be answering the question why not more implants were done yet in the months of September and October. Although I would like to remind everyone that the sales team is doing extremely great. 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. Thank you. One moment for our next question. Our final question comes from David Rescott with Baird. Your line is open. Great. Thanks for taking the questions here and congrats on the launch. I wanted to follow up on a couple points you made relative to the Q4 guide. First, on pricing, I believe the math, again, based on the 10-12 implants or so in the quarter versus the reported U.S. number puts you at that $20,000-$25,000 ASP. Just wanted to confirm that that on a U.S. dollar basis was correct. When we think about this number for Q4, again, we can see what's been done in October, and that puts a bigger number in the November, December time frame. 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 U.S. number? Yeah, sure, David. Thank you. Thanks for the question. 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 a one-for-one correlation with the revenue that's booked. 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. The portion that we spread out over time, there's that delta. In terms of the guide, we're not breaking out U.S. versus international here for the fourth quarter to get to 3.4-3.6. 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, and 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. That is how we're thinking about it and put the visibility into the number of cases that we're expecting here in the remaining 60-ish days of the quarter here. Okay. That's helpful. I guess on more of the P&L side, I think gross margins were in the low 60% this quarter. I'm guessing some of the rollout is impacting that. 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 rollout? Thank you. Sure, absolutely. As we think about gross margins, long-term, we have an opportunity to get our gross margins into the 80% range. I think it's really a multi-point 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 disposal patch perspective. It will also significantly reduce the cost. That is more of a tail end of 2026, early 2027, 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 unit. As we drive volume, we will see those continue to reduce over time. Then just overall working through supply chain and logistics as we are 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'll help be the final leg of the stool to get us up to that 80%+ gross margin range. In the near term, i.e. fourth quarter this year and 2026, probably not many drivers in the way of moving gross margin up from where we are today. I'd expect that more towards tail end of 2026 going into 2027. Okay, perfect. Thank you. You're welcome. Pardon me, this is Ockham, the operator. We did have some just recently queue up. Did you want to go ahead and take that question? Yes. Okay, one moment. Our next question comes from Paige Chamberlain with Wolfe Research. Your line is open. 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. I guess ahead, I'm just wondering if you can help us frame how to think about the phasing of unlocking widespread reimbursement in the U.S. and how that progress should flow into our build of the U.S. commercial ramp. 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. Thanks so much. Thank you. Thank you. And also refreshing me in a new voice during the analyst call. Thank you for the question on reimbursement. 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. It is providing a clear pathway for reimbursement with both Medicare but also commercial payers. In going forward, we do think that this will be the coding that will be further used. 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. We are also now seeing that this is the coding also where the latest innovation is used for HGNS. 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. It is, 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. 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. I think the HCSC and Blue Cross Blue Shield of Michigan, where we have CPT code 64568, is 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 pre-authorization perspective, we're seeing roughly a two-business-week cycle time from the time of submission to approvals. 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. It has been pretty consistent, and we're really very excited about that and look forward to seeing that continue. Maybe to close on this one, as well as you see and look at the future of this 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. We do not need to do the work on every listing with every single payer step by step because they are familiar with HGNS and what it can do in the treatment of more than just the OSA. Thank you. 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've all 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. This is, in fact, why we were in this business and what we want to do, offer this solution to seriously impact patients' lives. Thank you, and good afternoon and 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.