Hello, and welcome to Nyxoah's Second Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will 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 again. I will now like to turn the conference over to Pearson Dennis. You may begin. Thank you. Good afternoon, everyone, and I welcome you to our second 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 second 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 our 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 our Second Quarter 2025 Earnings Call. I'm extremely proud to announce that we received FDA PMA approval for our Genio system in the U.S. This result was the culmination of persistent, strong regulatory and clinical execution supported by the entire passionate and committed Nyxoah team. For U.S. patients suffering from obstructive sleep apnea or OSA, the Genio system provides them with a significant advantage from currently available treatment options. For physicians, they now have a choice to select the optimal AGNS therapy for their patients. For Nyxoah, it marks the beginning of an exciting journey in the U.S. This PMA approval confirms the safety and effectiveness of our innovative technology and authorized commercial distribution in the U.S., which now has actively begun. The Genio system becomes the first and only bilateral AGNS therapy approved in the U.S. for treatment of OSA. It's also important to note that the Genio system is not contraindicated for patients suffering from complete concentric collapse or CCC. Another key differentiator represented in our label highlights our ability to treat patients with positional OSA. This is important as, according to published data, a patient's AHI score can double when a patient sleeps in a supine position or on their back. Having this in our label serves as a validation of the clinical outcomes from our pivotal dream study, which met its primary endpoints regardless of a patient's sleep position. Also, note that complete concentric collapse or CCC is not contraindicated but is included as a warning in the company's label, as the safety and effectiveness for patients suffering from CCC has not yet been established for the Genio system based on U.S.-specific clinical data. Our goal is, however, to make Genio available for U.S. patients suffering from CCC as soon as possible. Therefore, we strategically elected to stop enrollment in the ACCESS study. We believe that the number of patients enrolled in ACCESS will have enough statistical power to draw meaningful conclusions on our effectiveness for complete concentric collapse patients. In addition, we see great results in real-life data from patients in Europe, where our CE marker already includes an indication for CCC patients. I'm also pleased to report that our DREAM study was published by the Journal of Clinical Sleep Medicine, which is a leading journal for the sleep community. I'd like to highlight a couple of data points that were published for the first time, which demonstrate a high level of patient satisfaction. The device demonstrated compliance of 85.9%, and a patient satisfaction was scored at 90%. This data confirms our early experience in Europe, and we believe the publication of the DREAM study will strengthen our U.S. launch and will also give us access to new international markets. Immediately upon receiving FDA approval, we started our focused U.S. launch with a commercial organization with over 50 highly talented and experienced professionals. This team is now executing on our two-pronged launch strategy. They will target high-volume hypoglossal nerve stimulation implanting centers, where they will position Genio as a differentiated option for patients suffering from OSA, and they will focus on developing strong referral networks with sleep physicians managing large populations of moderate to severe OSA patients who quit CPAP but are in need for treatment. Our U.S. sales team is already actively engaging with these targeted sites, working through the value analysis committee and pre-authorization approval processes. From a launch execution perspective, I am very pleased to report that already in the first week, we received several VAC and pre-authorization approvals. It's also very exciting to see multiple physicians with patients lined up who are running quickly to become the first to implant Genio commercially in the U.S. Regarding reimbursement, we have identified the use of CPT code 64568, which has been recognized by commercial and government payers for the OSA indication. This is the same CPT code used by our competitor, and we feel confident that we will be able to differentiate ourselves via our unique technology benefits and patient focus. As a result of our ongoing work with the American Academy of Otolaryngology and participation in the FDA's Early Payer Feedback Program educating CMS and major commercial payers on the clinical impact GENEOS can have on their OSA patients, positions us well for acceptance of pre-authorization submissions in the near term and favorable coverage decisions in the long term. With over 100 physicians in the U.S. already trained and additional weekly training sessions scheduled, there is strong momentum building in the medical community. Our initial traction in the marketplace is demonstrated by the many physicians lining up patients for a Genio implant in just our first week of commercialization. This early interest gives us confidence in the success of our U.S. launch. We have also identified demand from patients who are hesitant about receiving an implanted battery, which requires the need for subsequent surgery to replace this battery. The Genio system addresses this need with its unique and less invasive design. There has recently been a lot of discussion on the potential impact of GLP-1 on the AGNS market. Contrary to our competitor, we have strategically limited our patient population to those with a BMI below 32, since that is where the efficacy for Genio is proven. As a result, we believe that the eligible Genio patient population will grow, not shrink. This belief is based on several study data showing GLP-1's ability to bring patients with high BMIs of 37 and above down to a BMI level where clinical data demonstrates that Genio is effective. Without GLP-1, we would never be able to treat this high BMI patient population. While there might be patients with lower BMIs dropping out of the potential AGNS patient population, this will be outweighed by a significant number who become eligible for AGNS. On another topic, prior to Genio FDA approval, Inspire Medical initiated a patent lawsuit against Nyxoah. Since Nyxoah was founded, we have invested significantly in our IP portfolio, and we will vigorously defend ourselves in this matter and have the means to do so. This patent lawsuit will not impact our U.S. commercial launch, which is already underway and generating a lot of enthusiasm in the marketplace. To conclude my opening remarks, I want to emphasize that the FDA approval marks a pivotal moment for Nyxoah. Our bilateral stimulation technology offers a truly differentiated solution that makes us unique for patients. We believe Genio can fundamentally improve the quality of life for OSA patients by giving them a good night's sleep. With the current ongoing momentum and physicians already lining up patients for Genio, we are confident in our ability to execute a successful U.S. launch. With that, I'll turn the call over to our CFO, John Landry, for a financial update. Thank you, Olivier. We recorded revenue of EUR 1.3 million in the second quarter of 2025, compared to EUR 800,000 in the second quarter of 2024, for an increase of 73.8%. Gross margin in the second quarter of 2025 was 63.4%, or essentially flat to the second quarter of 2024. Total operating loss for the second quarter of 2025 was EUR 19.9 million versus EUR 13.3 million in the second 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 equivalent, and financial assets, was EUR 43 million at June 30, 2025, compared to EUR 63 million at March 31, 2025. We also have EUR 27.5 million available to us under our term-debt facility, which can be drawn down in two equal tranches of EUR 13.75 million each, which are subject to certain milestones. With that, I'd now like to hand the call back to Olivier to discuss his thoughts on the remainder of 2025. Olivier? Thank you, John. Before we conclude, I want to emphasize that this FDA approval represents a truly historic move for Nyxoah. I would like to thank all Nyxoah employees for their persistence and effort in making this happen. We have now officially entered the U.S. OSA market with our innovative GENEOS solution, and the launch is actively ongoing. The enthusiastic response from physicians and their patients reinforces our confidence in the success of this U.S. launch. We believe the remainder of 2025 will be a transformative period as we establish Genio in the U.S. market and advance our mission of making sleep simple for patients worldwide. We look forward to updating you on our progress on our next earnings calls. With that, I would now like to open the line for question and answer. Thank you. Ladies and gentlemen, as a reminder, to ask questions, please press star one one on your telephone and then wait for your name to be announced. To withdraw your questions, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of John Block with Stifel. Your line is open. Thank you. Hey, guys. Good afternoon. Olivier and John, obviously, a big congratulations to you and the team. I'll start off just any year-end 2025 metrics, you know, industry needs to focus on. Trade positions, I don't know, I'll throw that one out there, even though I know you said you already have, I think it was over 100. Can we be paying attention to that? The number of certified centers, the number of implants. I know it's early days, but just as we think about over the next three or four months, you know, where our eyes or where our focus should be as we think about exiting 2025 in regards to the Genio launch. Thank you. Yeah, thanks for the question, John. In terms of some of the leading indicators that we're tracking, obviously, we mentioned today the number of physicians trained. That's going to be something that we keep a close eye on, as that's obviously a leading indicator. We'll also be looking at the number of value analysis committee applications that we submit to the various institutions over time, as that's also another leading indicator. I think over time, we'll be looking at some other metrics, vis-à-vis maybe the number of accounts opened or pre-authorization approvals received. However, at this point in time, we're still working through that, and we'll share more on our next quarterly call with all of you. Fair enough. Thanks for that. I'll sort of pivot. Olivier, this one might be for you, but just, you know, obviously, there was the approval, but then there was also, I don't know, maybe call it like the favorable label that went along with the approval. Can you talk about how you expect to leverage the differentiated label, you know, such as no CCC contraindication, the sleep positional data? I know if it's more of a commercial question, if you would, but how do you expect to capitalize on that in the go-to-market when we think about over the next handful of quarters? Thank you. Thank you, John, for this question as well. Yeah, clear, it was for us a bit important win to also see this differentiation reflected in the label. As our mission is always make sleep simple, and that starts also by being certain that we can protect patients throughout the entire night, regardless in what sleep position they are. That is why positional OSA is so important that also there we can continue showing a highly effective technology and therapy. So far, Genio is the only technology that is offering this. That comes to the supine data and the positional OSA. When it comes to CCC, of course, there it's extremely encouraging to see that also FDA is recognizing this by not giving us a contraindication contrary to competition. As you know, with ACCESS, there we also did great work. We had our PIs implanting a significant number. Now we can closely, we can stop the enrollment earlier because also there we would like to advance on bringing this and making it available for CCC patients in the U.S. Both are reflected in the label. I know that you and many of your colleagues had questions on this in the past. Again, it is confirming what we were telling you, that bilateral stimulation is making a difference compared to unilateral stimulation and that this definitely will also help convincing physicians when they have to choose between the two available AGNS technologies. All right. Great caller. Thanks. I got more, but I'll hop back in the queue for now. Thanks, guys. Thank you, John. Please stand by for our next question. Our next question comes from the line of Adam Mater with Piper Sandler. Your line is open. This is Kyle on for Adam. Thanks for taking the questions, and we extend our congrats on FDA approval as well. Maybe just first to double-click a little bit on the commercial strategy that you discussed in your prepared remarks. I was hoping to get an idea of like which accounts you're kind of aiming to target first. Are they, you know, kind of centers from the DREAM pivotal study, some of the high-volume implanters? Could you just give us kind of any color around the accounts and the strategy there? Thanks. Yeah. No, no, definitely. As I mentioned in the script, we have a two-pronged approach. First of all, we go and our sales team will focus on high-volume hypoglossal nerve stimulation implanting accounts. Maybe as a quick reminder to this, you know that in the U.S., there are roughly 1,400 implanting accounts offering AGNS, but it stays a very concentrated market, meaning that 350 - 400 of these are high-volume accounts and are representing 75% - 80% of the total revenue. Those are the accounts the team will be focused on. We start with a team of 50 commercial people, of which 25 are territory managers. They will all have four to six of these accounts. We have built what we call a scalable technology. Every quarter, we will add a number of territory managers and increase the number of accounts so that we can cover as soon as possible all 400 of those high-volume implanting accounts. That is what we call our focused launch. Next, and I think as important, is also strengthening the referral paths. The way we are doing this at Nyxoah, it's totally different compared to the way it's done in the past in the sense that we will focus on patients that have moderate to severe OSA and that are quitting CPAP. Also, focusing on those specific patient groups will definitely strengthen the trust and confidence of sleep physicians and will also further make sure that patients in need for treatment will get a sleep surgeon that can help them with the Genio solution. That's how we plan to go forward with our launch strategy. That's super helpful. Thanks. Thanks Thanks for the color there. Maybe just for my second question, to shift over to reimbursement a little bit, how do you plan to go about that process here looking forward? Is there any logistical considerations around the work that you're doing with the different payers? More specifically, when can we expect to see some onboarding of some of the larger payers? Would it be fair by the end of this year, or is it kind of more of a 2026 story? Thanks again, guys. Yeah, thanks, Kyle. I can take this question. In terms of our reimbursement strategy, we have a comprehensive reimbursement strategy. We're using, as you may be aware, an established CPT code. At launch, we're using the 64568 code. We've worked closely with the AAO on that particular code. We've participated in the FDA's Early Payer Feedback Program. We've also been working with engaging CMS and major commercial payers in the U.S. around this particular code. As we work through this multifaceted approach and strategy, we expect these decisions will start coming in first for the pre-authorizations. We'd expect some of those to come in this year, clearly. I think we mentioned we had our first one now, but we expect more of those to come in over the balance of the year. As we start moving into more of the coverage decisions, if you will, that'll be probably more of a 2026 item, Kyle. Perfect. Thank you. You're welcome. Please stand by for our next question. Our next question comes from the line of Suraj Kalia with Oppenheimer. Your line is open. Hey, Olivier, John. Can you hear me all right? Yes, we can. Hello, Suraj. Perfect. Gentlemen, congrats on the approval. I know it's been a long time coming and on the label. Olivier, a quick one. Let me start out. You mentioned ACCESS enrollment has been stopped. I presume the DSME chimed in and helped you all reach that decision? Yes. When it comes to the ACCESS study, in fact, we reach a significant number of patients that are already implanted. That gives us the confidence that if we have to draw statistically conclusions that are statistically powered enough, I like to use this terminology, that we have more than enough patients. Maybe to give you some background, Suraj, on this, and I'm looking also at what is going on, what is happening in the Osprey study. We know that the number of patients that we are having, we have already more than doubled the number of patients that have an Osprey, where they're also looking at CCC patients. That's just as a side comment, but I think important information for you to know as well. The next thing on this, why we made this decision is we want to help patients with CCC in the U.S. as well, like we're doing in Europe in a very successful way, like we demonstrated in Australia in the Better Sleep study. Therefore, here, we cannot wait. When you have enough patients implanted, we do think it is a well-calculated decision to stop earlier, and that we can activate the 12-month follow-up timeframe. By the same time, same period next year, we will be able to publish those data. Then we submit a PMA supplement, and we should already be able to, end of 2026, beginning 2027, also to add this to our label in the U.S. and be able to help CCC patients that are currently contraindicated for AGNS. Got it. Olivier, I'll question rules. Just the second one from me. Olivier, how are you thinking about patient outreach and practice in the products specifically to find CCC, lack of battery, whatnot? How are you thinking about targeting this? Do you think launching that, given it's the same Inspire DS, makes sense, or are you intending on launching a targeted approach for bilateral stimulus? First of all, Suraj, we will further leverage on our clinical data. I think this is really important so that we look at patient phenotypes where we know we are extremely efficient, you know, the adult patient population. When it comes to AHI, and I would like to point this out in DREAM, our AHI range is 15- 65, which is already different compared to competition where it's 20- 50. We are already able to start to demonstrate a strong number, 15 - 65. That is one aspect. Another aspect is what we learned in market research is that for physicians, it's extremely important to know that their patients will be protected throughout the entire night. This is something that is not only resonating well with ENT surgeons, but it's very well resonating with sleep physicians who have to refer patients because they see this effect. When they start studying polysomnography sleep exams, they see exactly when a patient is in what position. It's a great benefit being able to show protection throughout the night for a sleep physician, providing them confidence when they refer a specific patient all the way to an ENT surgeon for a Genio. Last, when it comes to the outreach, yes, we have a focused launch. We start with 25 territory managers. They all cover four to six centers. I think I already explained how concentrated the business still is in the U.S., and we will scale quarter after quarter by adding roughly 50 new territory managers and each time adding up to 75 new implant sites. That, to John's point, will also become one of our key metrics in measuring our success going forward. It gives us the ability in short term also to reach all 350- 400 high-volume sites. I hope this is answering your question. Thank you. Please stand by for our next question. Our next question comes from the line of Ross Osborn with Cantor Fitzgerald. Your line is open. Hey, guys. This is Matt Park on for Ross today. Thanks for taking the questions and congrats again on FDA approval. Starting off with Olivier on VAC approvals, how should we think about a reasonable pace for account openings through the remainder of 2025 and into 2026? Are there any headwinds here that we should be mindful of? Yeah, Matt, it's an excellent question in the sense that what the team did really successfully is start segmenting also the VAC committees by time they need in order to reach a decision. What we learned is you have some that go extremely fast. As I already mentioned, we have the first, we have several of those fast VAC committees where we already passed the VAC committee. You also have a number of VAC committees that will really take their time, and time can go up to nine months in some cases. Here, we will focus and follow the segmentation. The fastest, of course, there we are present immediately, and that's how we further scale up. I do not want to set expectations on saying this is the precise number that we will achieve by the end of this year, but it is clear that in our targeted approach, all the hospitals that we are targeting, they also will go through the VACs, and we expect all of them to gain us an approval in the coming six months. Got it. That's super helpful. That one for John here. You know, as we're thinking about spending the back half of the year and into 2026, as you guys build out your commercial infrastructure in the U.S., can you kind of walk us through some of the puts and takes around operating leverage that we should be mindful of? Sure. Absolutely. From an OpEx perspective, we don't provide specific guidance, but maybe we can provide some color in terms of how we're thinking about the investment levels. For the back half of this year, in terms of OpEx spend, we'd expect to see R&D continue at a pretty consistent rate and then maybe be a little bit up year- over- year, considering some of the investments that we're making in the IP litigation front. From an SG&A perspective, that will be up, obviously, year- over- year, considering the investments that we've made in our sales and commercial efforts in the U.S. with the 50 highly talented professionals we have in that organization. As we look at 2026, from an overall investment level perspective, we'd expect the majority of the increase next year to be in the way of SG&A as we increase the size of the commercial organization again by expanding it by those scalable units of 15 territory managers over the course of the year. We could expect to see potentially the SG&A spend nearly double in 2026 over the level seen in 2025. Got it. Thanks for the color. Congrats again, guys. Thank you. Please stand by for our next question. Our next question comes from the line of David Rescott with Baird. Your line is open. Great. Thanks for taking the questions and congrats on the approval here. I wanted to ask first on reimbursement, the VAC, the prior auth processes that you've called out in the prepared remarks. I guess, can you just help us understand what considerations go into those VAC and prior auth conversations. Are you definitively kind of locked into reimbursement there? Is that fully ironed out? Just how do we think about what the prior auth and VAC processes are relative to what the line CPT code and commercial coverage has? Sure. Yeah. Thanks for the question, David. Yeah. Early on, it's clearly early on in the process, but in terms of the approvals that we receive vis-à-vis the VAC and/or the pre-authorizations, the answer is yes. We've gone through the process. I think really what we're looking to do there is demonstrate the clinical efficacy and the effectiveness of the technology, certainly utilizing the HGNS code, the 64568 code on the CPT side. We've been able to have success in demonstrating that, at least in this early stage, to those hospitals and accounts and centers where we've completed the VAC. As Olivier mentioned, there are various lengths of process for these VACs as well as the pre-authorization process. The VAC approvals can range anywhere from very short periods of time up to nine months. In the pre-authorization process, it's extended as well. That's where we're at at this point in time and look forward to continuing to build this body of approvals. Yeah. Maybe in addition to this, if you allow me to add, AGNS, there is no longer one company that is offering an AGNS solution. I mean, with Genio, we entered the market. There is now an option to choose. That is why today, as of today, there is an AGNS treatment solution, and there are different companies offering this. I think that's also important. The previous work done in the past was also linked to AGNS. All the VAC quantities recognize this, and they know what it is and what it can do. As of today, there are two companies who can offer a solution, and it's up to their physicians that will decide together with the patient what solution they will choose. Okay. Great. Maybe on the CCC patient population, you know, you've got the no contraindication. There's the warning that it wasn't tested, but you have ACCESS that is coming. I guess I don't know if you called out a timeline. I might have missed it on the ACCESS side for when that data should read out. How do we think about the patients that are on the CCC side that can get treated today versus those that you can kind of go after and target once you have ACCESS fully in hand? When it comes to the ACCESS study, we stopped the enrollment. The time clock for 12 months can start. Twelve months from now, we will have the data of all ACCESS patients. Based on this study data, we will submit a PMA supplement. Normally, this takes roughly another six months before they grant you a supplement. If you do the math, the earliest end of Q4 2026, beginning Q1 2027, we could have CCC patients added to the label. Today, with having no contraindication, we are very proud that FDA is recognizing already that CCC is something where they would like to see U.S.-specific data before adding the label, but where they also recognize the fact that CCC should not be a contraindication. I think that's an important first step in the direction in opening it up in the U.S. market for patients, OSA patients suffering from CCC. Okay. Would it be fair to assume that you can start treating CCC patients since there is no contraindication and maybe pump the gas on that once you have ACCESS out and the PMA supplement in, or in the near term, are you really kind of just waiting for the ACCESS results? Thank you. In the near term, we are waiting for the ACCESS results. Let me be very clear on this one. We would never promote an off-label indication. Today's CCC, it's also for Genio off-label in the U.S. We would never, ever promote this. On the other hand, it is clear that it's not a contraindication, and it is in the warning section of our labeling. Physicians know what this means. Okay. Perfect. Thank you. Thank you. Please stand by for our next question. Our next question comes from the line of Michael Pollock with Wolfe Research. Line is open. Hey, good afternoon. I have two. First one, pricing. Can you confirm, as you launch now in the U.S., intent to price at Inspire's level, $25,000, or has the thought process on pricing changed? No, indeed. We use the same CPT code, and we are following also the price strategy that comes with the CPT code to your point. Okay. That's what I figured. Just thought it worth clarifying as we go into launch. My second question is, as you look to open accounts, is there an ask you're making of these surgeons? You invest in them. You train them. They're going to be, you know, bargaining and competing for patients on their behalf. That's an investment that you make. What kind of return do you ask of these initial centers, if anything? I'm just thinking like, look, they're all in the business of hypoglossal nerve stim. They have large wallets. What is a share of wallet that you're wanting? Kind of a maybe not a firm commitment, but a soft commitment from these surgeons as you get going in this initial cohort. Is it 10%, 20%? Is it more? I'd love a feel for how you go about those initial conversations and signing up this initial group of implanters. Thank you. No, no, no. Thank you, Mike, for this question. It's also a question, of course, as you can imagine, that we internally discussed as well because we have a lot of demand from physicians who are reaching out to be trained on the Genio system, and we can, unfortunately, not train all of them at the same time. What we are asking is, before a physician is eligible to join a training or invited for a training, they need to come with five patients, clearly defined patients, and we use the criteria as the same criteria as in the DREAM study. We ask them to come with five patient cases. Then they get a training. We can already discuss those five patients so they can be implanted right after they go back after being trained. That's what we do. When it comes to market share, because you were alluding also, do you ask 10% or 20% market share? Honestly, we don't at this stage. We do think that if they are well trained, high-quality training, they do their five cases, meaning that they will all go through their surgical learning curve, we are convinced that they will make the right decision when patients are coming. Patients will know if they can choose a bilateral stimulation with a single incision. You know, all the different differentiating factors, full body MRI compatibility, that we will be able to capture a lot of patients with our Genio technology. Thank you for the color. Thank you. Ladies and gentlemen, that concludes our question and answer session. I will now turn the call back over to Olivier Taelman for closing remarks. Thank you again for your time today and your continued support of Nyxoah. As I mentioned in the beginning, this is the most exciting time in our company history. We are so excited to be able to launch in the U.S. I would also not forget our international markets where we're also making good progress, but it's clear that the market is in the U.S. Finally, after so many months, years of hard work, I'm pleased that we can enter this, and the entire team is extremely excited. You will, and I will look forward also to updating you on our progress in the coming months. Thank you all again, and have a nice day. Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.