Nyxoah SA Aktie

I'm on the medtech team here at Bank of America. Really happy to introduce our next presenter, Nyxoah. We have CEO, Olivier Taelman, to present.

Good afternoon, everyone. First of all, thank you, and thank you, Bank of America, for having us and to be able to explain a little bit and talk a little bit more about the Nyxoah story. When we talk about Nyxoah, we are talking about obstructive sleep apnea and the treatment of obstructive sleep apnea by offering a neuromodulation solution.

Before I dig in a little bit further into our technology, I would like to talk a little bit more about the market space. I think everyone is familiar with someone who is struggling from sleep apnea wearing a CPAP mask. It is a huge market in the U.S. It's a huge market globally. But when we focus on the U.S., we are talking about a $10 billion market opportunity or roughly 500,000 patients that are annually eligible for treatment because they suffer from moderate to severe obstructive sleep apnea.

What we offer as Nyxoah? We offer a totally differentiated and unique neuromodulation solution. And I will be walking you through this in a couple of slides and showing also the technology. We have compelling clinical evidence that resulted in FDA approval. We obtained FDA approval last year in August, and we are currently actively launching. Yesterday, in fact, I did the earnings call for our Q1 results now 6 months post FDA approval. In the meantime, we treated over 1,200 patients in Europe to be very precise and the longest implanted patient with our Genio technology is already more than 7 years benefiting from the technology and as I was mentioning, I think the most exciting point that we are currently going through in the stage of company is that we fully transitioned from a clinical stage company into a commercial stage company in the U.S., but also in other countries around the globe.

Now before I continue and go a little bit more in depth on the technology as such. I make it like a case of honor to start by saying why are people in need for treatment when you suffer from obstructive sleep apnea. And to make a long story short, every time when you go to bed and you start sleeping, you will have an airway obstruction that can be 15, 20, 30, 40 times every hour, and that is causing a lack of oxygen to your vital organs. So what you see is when you are not treated for your obstructive sleep apnea, that the risk for comorbidity significantly increases, the risk of cardiovascular incidents go up by 5, the risk of heart failure almost triples and the risk of stroke doubles.

There is also a clear link with a high prevalency in other key chronic diseases. I'd like to point out diabetes type 2 because we're also seeing that this is a fast-growing business in the current society globally. And there, we already know that 72% of all type 2 diabetes patients are also suffering from obstructive sleep apnea. When you look at obstructive sleep apnea, there is clearly a graduation linked to the severity. If you have 15 or more obstructions every hour, you are a moderate obstructive sleep apnea patient and you are in need for medical treatment. If you have more than 30 obstructions every hour, you become a severe patient and you definitely are in need for treatment. Sometimes, and it's a little anecdote, people are always talking. Will this also help against the snoring? The answer is yes, because every obstructive sleep apnea is snoring, but it's not because you snore occasionally that you suffer from obstructive sleep apnea.

The treatment options, as I mentioned before, the golden standard still is the CPAP mask. Besides the CPAP mask, there are also mandibular advancement devices, mainly prescribed by a dentist. What we are seeing is that they are more focusing on soft or less than moderate obstructive sleep apnea and also from a clinical evidence perspective, they are not so backed up. It's also highly costly. It's all out-of-pocket pay and for those who can benefit from them, the better. But it's not the kind of treatment option that you use if you're suffering from moderate to severe OSA.

There was traditional surgery. It's highly painful. We're also seeing that success rate is relatively low. And we see also that it's more something that is done with the old generation of ENT surgeons and that with the younger generation is no longer part of their treatment palette.

Now when we dig in a little bit deeper to Genio and our solution, I was talking about a totally differentiated solution. So we have 2 components. There is 1 implantable aspect, the implantable stimulator as you can see on the bottom right, it's a passive device. There is no battery implanted. And it has 2 pedal electrodes. Why 2? Because if you look at the hypoglossal nerve, it also splits in 2 branches. And we are the only company with a technology that is stimulating both branches. Now why is this important? Two reasons. One, it will give you a strong therapeutic effect. And second, it also will consume less energy. And why is this so important? Because when a patient is sleeping, the last thing you want to do is wake the patient up by stimulating too strong or too intense. When you have a bilateral stimulation, you get the same strong effect with less stimulation needs from electric pulses.

Because it's a passive device, it also automatically generates a full body MRI compatibility. As I touched earlier, a lot of the people are having other comorbidity factors. So it's also important that you know when you're implanted, you never need to worry when there is an MRI scan that is needed.

Now going to the second part, it's the external or the smart wearable component. As you can see, the gentleman in the drawing is wearing this under the chin. So it's a very small wearable component that is containing 2 things: battery and through induction, it will activate the passive implant and it also contains software. Now, we call it smart because it understands what kind of stimulation it needs to send through to have an effect on the airway opening of the patient. And also by having an external battery, there is no need for repetitive surgery replacing a pacemaker that could be depleted. There is also no need for repetitive surgery when there is a software upgrade, we simply push it through like people are used to with their smartphone.

In the morning, when you wake up, you just open the app on your phone and you get a lot of information on your sleep quality. And we also learned that this is something that is highly valued by patients because it gives them not only more comfort, but it also give them a kind of involvement and a kind of power of their technology and seeing that their sleep quality is increasing. As a medtech device with an implantable component, it's clear, everything starts with robust clinical evidence. I will not go too much in depth on this one, but I would like to highlight 2 aspects. One, there is the effectiveness of your technology. So we reach our primary and secondary endpoints, expressed in an index, the hypopnea index and oxygen desaturation index. So we met all our primary endpoints. And then the next aspect important for physicians and patients is, is it a safe technology when you implant and also there with 8.7% severe adverse event rate, it brings us and makes us one of the lowest or one of the technologies with the highest safety profile that you can find in neuromodulation.

Important, once you are implanted is that we see that 82% of all patients implanted with Genio, we are able to reduce their AHI below 15. As I mentioned before, 15 is the cutoff point for the need for surgical treatment. If you are below 15, your risk of cardiovascular stroke et cetera, is identical to people who are not suffering from OSA. So 82% of all our patients implanted or having an AHI that is being reduced below 15 and bringing them back to normal standards.

Commercialization. And I was mentioning FDA approval, the U.S. is the largest market for obstructive sleep apnea. So it has been our goal from the beginning to enter this market and to try to be successful. If you look at our commercialization strategy, we are using a so-called smart follower strategy. On one hand, we focus on where the patients are, and they are in high-volume hypoglossal nerve stimulation center with ENT surgeons that are very familiar also with our competitive or with competitive technology. That's where we go with our sales force, position our technology as a totally differentiated technology and then also go after patients that are showing up and being referred by sleep medicine.

It brings me to the second part of the strategy. We will immediately from the beginning, also try to partner a sleep doctor with the ENT surgeon colleague so that when it comes to patient phenotyping identification, the sleep physicians, they have a crucial role because they are also the CPAP prescribers. And then once the surgery is done, we also make sure that they stay involved also in managing, in fact, the implanted patient with their technology. So that's how we launch in the U.S. We learned that in the U.S., you have roughly 400 implant sites that are generating 70% of the total volume in hypoglossal nerve stim. So it's a very concentrated. The 400 accounts, they are generating, if I would put some dollar amounts behind more or less $600 million to $700 million on annual basis.

I have a team, commercial team in the U.S. of 60 dedicated people. 40 of them are the sales reps, then we have roughly 10, 15 field engineers. There is some marketing, market access people and there are also some clinical and training education people. Reimbursement-wise, has been a hot topic lately in hypoglossal nerve space. I think finally, there is clarity. And I'm also extremely pleased that we were not directly impacted with all the changes and the unclarity that was taking place.

Let us look at some results and some numbers. So 6 months post launch, we were able to train in the U.S. 207 surgeons with our Genio system coming out of 125 high-volume sites. We had 62 surgeons trained in Q1, just to give you an indication, how fast it's growing and how fast the uptake is. We have currently 91 active sites, all of the 125 high volume sites we targeted. 34 new accounts were activated in Q1. What do we mean with an active account? There are 2 parameters, the surgeon needs to be trained and also the value analysis committees need to give them their approval, there need to be a price in place so that we can do business. Once all this is in place, we can start recruiting patients. And exiting the first quarter, next to the implants we did, we have 241 patients lined up with a full prior authorization file submitted to a commercial payer that will be implanted in the quarter going forward.

We also invested in some more feet on the street. We hired 15 more sales reps so that in total, we have now 40 people that can cover all of the 400 high-volume accounts. From a finance perspective, in Q1, we generated EUR 6.4 million. Apologies, I have to talk in euros, but we are still at headquartered in Belgium, and that's why we use the euro amount still today when we report our finance. You can see it was a nice growth, 13% global growth versus Q4 knowing that Q4 always is followed by Q1, where you see a lot of seasonality, 13% growth was a very strong result. But I think what was even more stronger and everyone is looking for is, how is the U.S. growing. And there, we generated EUR 4.3 million of showing a 25% growth over Q4. So if you combine everything, we can speak about a successful first 6 months. And we know that there were a lot of more patients that are lined up to be implanted. So the next quarters will be -- continue to be strong. We gave guidance up to 30% growth versus Q1 in the second quarter.

Our cash and our balance sheet, we are still EUR 26 million on the balance sheet. We will draw down a loan from the European Investment Bank of another EUR 13.8 million. If you look at the guidance, I was already referring to this, we are giving 25% to 30% guidance for the second quarter in the U.S. over the first quarter. If you look at the annual revenue target first year of launch, we are forecasting to be between EUR 36 million to EUR 40 million. And I do think that is a strong uptake in the first year of launch in the medtech company, gross margin 60% to 62%. They will further increase to 80% when volume also will start increasing and our total operating expenses will be between EUR 97 million to EUR 99 million.

Briefly, international markets, and I will not bother you too long with this, but I just would like to share that we did our first commercial efforts in Germany. And Germany was not incidentally picked. We went there because competition was there as well, and we did a commercial proof of concept. What have we learned? We learned 3 things: one, that when we entered first year, we were able to take 20% market share. Second thing we learned in this that when we went into the second year of launch with our referral strategy, the market share increased to 25%. And the last thing we learned in this in 3 years, we were able to go from launch all the way to profitability in 3 years already.

I think my time is also up. So this is the last slide. What can you expect from us going forward? We will selectively invest in innovative leadership. So we're talking about smart wearables and intuitive apps. We are working on a cloud-based solution and telemedicine and of course, since we are increasing volume and we are capturing all data, we also will incorporate AI tools to make sure we can learn and we can learn fast.

With this, I would like to thank you. I will not go too much over time. And once again, I hope it was interesting listening to this. And if you have someone who is suffering from the obstructive sleep apnea, you know where to find us. Thank you.

Good day, and thank you for standing by. Welcome to the Nyxoah First Quarter 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I'd now like to turn the conference over to your speaker today, Pearson Dennis. Please go ahead.

Thank you. Good afternoon, everyone, and I welcome you to our first quarter 2026 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 first quarter 2026 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 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, which was filed with the Securities and Exchange Commission on March 26, 2026.

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 first quarter 2026 earnings call. Let me start with the Q1 2026 overview. The first quarter of '26 marked our second full quarter of U.S. commercialization, and we are encouraged by the strong execution of our U.S. launch. Specifically, we delivered on our commitment to drive 25% sequential U.S. revenue growth in the first quarter of '26 versus the fourth quarter of '25. In the U.S., we are seeing consistent momentum across our key commercial indicators, including surgeon training, account activation, patient prior authorization submissions and procedure volumes. Internationally, our revenue in the first quarter of '26 was consistent with the fourth quarter of '25, which represents strong performance as we were able to grow the business and avoid the typical sequential quarter decline from the fourth quarter to the first quarter. On a worldwide basis, I'm pleased to report that we grew our revenue by sequentially by 13% sequentially over the fourth quarter of 2025.

Let's now dig in, in the U.S. commercial update. The U.S. launch remains the primary driver of our worldwide revenue growth and our key priority. During the quarter, we continued to execute on our focused commercial launch strategy and further expanded our U.S. commercial field presence with an extra 15 sales reps who are now fully operational, enabling us to cover up to 200 high-volume hypoglossal nerve stimulation accounts ending Q2. I'm pleased to report on our U.S. launch key performance indicators as of March 31, 2026. We have trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained on the Genio system.

We have activated 34 new accounts in Q1, bringing the total of 91 active accounts out of our 125 targeted accounts. Active accounts are defined as surgeons trained and VAC committee approved. We have 241 new patients submitted under prior-authorization and still pending at the end of Q1.

We have trained 50 new sales reps, bringing the total to 40 fully operational sales reps as we enter Q2. 6 months post launch in the accounts where we are already active, we estimate our market share to be between 12% to 14% on average. With the addition of 50 new sales representatives in the U.S. who are fully trained in Q1, we will be able to cover 200 out of the 400 high-volume AS accounts beginning in Q2. We also recently conducted a market research study of 100 U.S. hypoglossal nerve stimulation implanters. We learned that 88% of ENTs believe it is important to have multiple hypoglossal nerve stimulation options for their patients.

All Genio trained surgeons plan to adopt Genio in their practice. The top-sided reasons for adopting Genio were bilateral stimulation, no implanted battery and offering an alternative option. Sleep medicine is the single biggest source of their patient referrals and 84% of surgeons collaborate with sleep medicine colleagues to manage AGNS patients. The result of this market research confirms that our focused launch strategy on high-volume hypoglossal nerve stimulation implant centers in combination with building sleep physician partnerships will drive further Genio adoption.

Let me now cover one of the hot topics of Q1, the hypoglossal nerve stimulation reimbursement landscape. In order to provide you with a structured update, I would like to split it up between commercial payers, Medicare and the WISeR program. Starting with commercial payers. They represent approximately 90% of our cases in Q1. Coverage is broad and stable. Genio claims continue to be processed under the CPT code 64568 or even under the CPT code 64582, depending on payer policy and individual case review.

For example, UnitedHealthcare recently added CPT 64568 back to their existing AGNS policy in parallel to CPT 64582. So both codes are available for AGS. UnitedHealthcare represents one of several commercial payers, which have both CPT 64568 and the 64582 listed as available codes for AGNS procedures, including Genio.

Through the end of the first quarter, we maintained a approval 100% approval rate on reviewed prior authorization submissions. Now moving into the Medicare side, which only represents approximately 10% of our cases in Q1. The year started with coding uncertainty negatively impacting AGNS implants. On February 26, however, CMS provided clarity by issuing AGNS-specific C-codes for facilities.

Claims for Genio implantations are submitted under the C-code C8011. This code represents a facility fee mapped to the APC Level 5 at $31,526 in the hospital outpatient setting and $27,563 in the ASC setting. This is equivalent to the existing CPT code 64582 in hospital settings and slightly higher than the CPT code 64582 in the ASC setting. This results also in price parity at facility level for Genio and competition. Next, from a physician fee perspective, claims continue being submitted under CPT64582 at $722. When it comes to the use of modifiers, let me reiterate that it is a physician decision based on the specific surgeon work performed and that Nyxoah is not advising to use of a modifier.

As to the newly established WISeR program being an AI-supported prioritization tool rolled out by CMS in six different states since January 1, 2026, we have achieved a 100% approval rate of our submitted Medicare patients. The fact that reimbursement didn't hinder our Q1 launch momentum is the result of the expertise of our market access team, the collaborations with experts in that field, our participation in the FDA early payer feedback program and the proactive education of all our customers. Because of these factors, we expect continuity for '26 and into 2027.

As part of the ongoing CPT editorial panel discussion regarding the future of AGNS coding, the panel has indicated that there is no intention to lease any AGNS technology or fund without appropriate coding. For 2028, we understand that there are currently 2 parts to support continued coding being dedicated CPT codes for the different AGNS technologies or creating a comprehensive AGNS coding set. Following the model laid out in the CMS C codes, we learned that competition has chosen to seek its own dedicated code, which we are prepared for as well. Alternatively, specialty societies may seek to engage in a broader exercise to provide further clarity regarding coding in the AGNS space, creating a comprehensive AGNS code set. We will take our lead from the specialty societies, including AAO, [ HNS ] since their actions are driven by the physicians performing these procedures.

Let me now move to an international update. Internationally, we are seeing continued growth, and we managed to overcome seasonality versus Q4 '25. This was driven by a strong performance in Germany, where we are going deeper in existing accounts, continued therapy adoption in the Middle East and successful entries in the U.K. and the Netherlands. However, we maintained a disciplined financial approach focused on reaching breakeven as demonstrated in Germany, 3 years post launch.

With that, I will now turn the call over to John for a detailed overview of our financial results.

Thank you, Olivier. For the first quarter of 2026, gross revenue was EUR 6.7 million before EUR 300,000 in deferrals due to the delivery of disposable patches, which are delivered over time, resulting in net revenue of approximately EUR 6.4 million. This represents 13% sequential worldwide growth compared to the fourth quarter of 2025. U.S. net revenue was EUR 4.3 million, representing approximately 25% sequential growth compared to EUR 3.4 million in the fourth quarter of 2025.

Our U.S. revenue growth reflects continued expansion in account activation, increasing procedure volumes and growing surgeon adoption. Gross margin in the first quarter of 2026 was 57% as compared to 62% in the first quarter of 2025. The decrease in gross margin was due to production yield issues in the quarter, which have been addressed.

Operating expenses were EUR 24.2 million in the first quarter of 2026 as compared to EUR 21.4 million in the first quarter of 2025. The increase in operating expenses was driven by increased investment in the U.S. commercial organization, including sales, marketing and market access functions. Non-GAAP cash operating expenses were EUR 21.7 million in the first quarter of 2026 as compared to EUR 19.5 million in the first quarter of 2025. The increase in non-GAAP cash operating expenses also reflects increased investment in the U.S. commercial organization. As of March 31, 2026, cash and cash equivalents and financial assets totaled EUR 25.9 million. In the second quarter of 2026, we expect to draw approximately EUR 13.8 million from the second tranche of our European Investment Bank loan.

Now let's turn to guidance. We expect U.S. net revenue for the second quarter of 2026 to grow approximately 25% to 30% sequentially over the first quarter of 2026. For the full year 2026, we expect worldwide net revenue in the range of EUR 36 million to EUR 40 million. We expect gross margin in the range of 60% to 62%. We expect total operating expenses in the range of EUR 97 million to EUR 99 million. We expect total non-GAAP cash operating expenses in the range of EUR 88 million to EUR 90 million.

Please note that our total non-GAAP cash operating expenses for full year 2026 reflect a 5% to 8% sequential increase over non-GAAP cash operating expenses of EUR 83.5 million for fiscal year 2025. Strategically, we will focus our investments in supporting our U.S. commercial activities, including sales, marketing and market access as well as key R&D initiatives, including our Genio 2.2 upgrade, which includes a new suite wearable with upgraded software and a low-cost disposable patch to be launched in early 2027. We decreased our total non-GAAP cash operating expenses by EUR 300,000 to EUR 21.7 million from the fourth quarter of 2025 to the first quarter of 2026.

We also decreased our non-GAAP cash R&D expenses by EUR 2.9 million sequentially from the fourth quarter of 2025 and reallocated this capital into our U.S. commercialization efforts. We are applying the same principle for the G&A portion of our SG&A operating expenses, which if we were to break them out separately, you'd be able to see the transition from G&A-related expenses to U.S. commercial activities. Long term, we expect to drive gross margins over 80%, and we will continue to manage our non-GAAP cash operating expenses tightly while investing in growth and gross margin improvement drivers.

We believe this disciplined approach will allow us to achieve revenue breakeven below EUR 150 million in revenue. With that, I'd now like to turn the call back over to Olivier.

Thank you, John. As we enter Q2, our priorities remain clear: further execute on the current launch momentum in the U.S. capture greater market share in our targeted high-volume accounts, maintain a disciplined financial approach to OpEx and cash management.

Before closing, I would like to thank the Nyxoah employees for their contribution in making Q1 a successful quarter.

With that, I would like to open the line for question and answers.

[Operator Instructions] Our first question today will be coming from the line of Adam Meter of Piper Sandler.

Congrats on the solid progress. Two from me. The first one is on the guidance front. I wanted to ask about the full year '26 revenue guidance that you provided, and that is above where the Street is currently sitting. If you look at kind of where you've guided Q2 U.S. revs, it does imply a bit of a step-up in the back half of the year. I know Q4 is typically a seasonally stronger quarter, but maybe just talk about the confidence in achieving the full year outlook, especially in light of the ongoing reimbursement situation and talk about some of the kind of key drivers of the ramp. And any help on quarterly phasing would be appreciated.

So let me start by answering the question. So first of all, as we already communicated, we continued adding salespeople into our -- into the field. So we added 50 new sales reps, bringing the total to 40 salespeople, which enable us to cover 200 out of the 400 high-volume accounts. As you also know, surgeons, when they start implanting, they go through their surgical learning curve. This takes roughly 2 to 4 implants. And then you also see that they are scaling up. What we have learned in Q4 and in Q1 is that we got a lot of positive feedback from surgeons after their first cases.

And on top, after seeing the first patient activations, what was confirming the strong away openings that they saw during the surgery gave them even more confidence in start treating immediately more new patients. So that's one aspect. So you have more feet on the street and you also have more experienced surgeons. In parallel, the VAC approvals, you know that we cannot control the time lines. Sometimes it varies from 1 week to 2 weeks all the way up to a couple of months. Also here, we are seeing great progress made, and we have now 91 active accounts already out of the 125 targeted sites with our initial 25 sales reps.

So also this is driving an acceleration in adoption. And of course, in the end, there is also the patients and also the patient referral part coming from sleep physicians. I'm extremely pleased also that I was able to announce that we have 241 real patients with a submitted prior authorization file to a commercial payer while exiting entering Q2 exiting Q1. So if you add those leading indicators up, that is giving us confidence of showing continued strong double-digit growth, even further accelerating in the second half of the year. But now John will add some numbers to this as well to answer your question completely.

Excellent. Yes. In terms of where we're at and what we're looking for productivity, we expect in the back half of the year, to your point, we expect to see our revenue growth accelerate given the fact that we have our new training class that's now productive in the second quarter this year and then we will ramp up over the rest of the year. So the sequential growth rate I mentioned, 25% to 30% in the second quarter, we would see that accelerate in the third quarter. probably about the 40 -- low 40% to 45% range and then in the 50% range into the fourth quarter of the year, which, as you know, is a seasonally stronger year, especially in the U.S. as people have fully exhausted their deductibles. So when you run that math, that's what helps provide some of that back-end growth that you'll see in the model to achieve that U.S. revenue target.

And maybe last on this one, let's also not forget that I think we can say that reimbursement is fully clear and supported from both CMS with the C codes and also from commercial payers. So also this is definitely not a hindering factor as we experienced already in Q1, not to be a hindering factor.

Okay. Fantastic. That's a lot of very helpful color. I appreciate all that. For the follow-up, I wanted to switch over to reimbursement, everyone's favorite topic. Olivier, I guess the question is really around kind of the longer-term strategy for Genio and how you're thinking about a permanent CPT code. And I know in your prepared remarks, you mentioned the AMA CPT panel meeting earlier this month.

We did see the proposed meeting agenda, and there was a hypoglossal nerve stimulation code on that agenda. But from our vantage point, that actually seemed to kind of describe the competitor device versus Genio. So would you agree or disagree with that assessment? And then just any help that you can give us in terms of pathway forward to kind of a more permanent reimbursement coding solution and time lines for Genio would be appreciated.

So I do think that for 2026, everything is very clear now. CMS has the C codes. We know the WISeR program. There we have obtained 100% approval prior authorization approval ratio. And we also know with commercial payers that we are both covered under the CPT 64568 and 64582. So 2026, I do think is crystal clearing going forward and is completely derisked. Now we were also participating during the editorial CPT panel discussion. And of course, there, we were listening and actively participating in this discussion focused on 2027 and even 2028.

So for 2027, we expect no change on the Medicare side. The C-code framework and the physician payment under the CPT 64582 in place and operational. On the commercial side for 2027, just listening to what was discussed and also talking with experts, we do think that the CPT 64568 will be revised and will apply solely to the vagus nerve stimulation, directing all AGNS procedures away from that code and the code would migrate into 64582 code.

Now in going to 2028, and that's also touching to the remark that there was a competitor CPT application for a dedicated new CPT code, which is correct. I mean that was part of the agenda of the editorial panel discussion. So for '28, what we are hearing is that there are two roads in going forward.

One would be there is the move in the direction of CPT codes, dedicated CPT codes for all reimbursed AGNS technologies. The second road would be that there would be a more comprehensive AGNS coding set where also all reimbursed AGNS technologies would fall over. But that needs to be further clarified. Now when it comes to Genio, when we go to a CPT dedicated code, we intentionally did not yet submit this on the agenda of the editorial panel, but we are well prepared, and we will be submitting this going forward.

On the other hand, we will always take a lead from specialty societies, including AGNS since their actions are driven by physicians performing procedures. So the conclusion is 2026, we know that everything is derisked reimbursement-wise. '27, we see it the same way.

Medicare side completely clear from the commercial payers, there are coding in place. It might be that everything is more migrated to the 64582 code. And in 2028, I'm sure that editorial panel will continue discussing. They made it already clear that there will be no orphan AGNS technology and whether it evolves into dedicated codes, we will be prepared for this, whether it evolves to a more comprehensive AGNS coding set, we will follow the lead from society in this. I hope this is answering your question.

[Operator Instructions] Our next question will be coming from the line of John Block of Stifel.

Olivier, the first one is the 241 patients submitted under prior authorization at the end of the first quarter of 2026, can you remind us what that number was at the end of the fourth quarter of 2025, sort of apples-to-apples? And then how long does it take to get those patients through the approval process, which I believe you said is still sitting at around 100% from your vantage point?

Yes. So for leaving Q1, as I was saying, 241 -- when we were leaving Q4, we had approximately 116 patients under prior authorization. And how long does it take? I mean commercial payers, they have up to 30 days to come back with the approval. As a reminder, so far, we have a 100% prior authorization approval rate. And then it depends hypoglossal site to hypoglossal site because we are talking about high-volume sites in getting OR time planned, also getting surgical time because it's not only the site that is high-volume site, also the surgeon is a high-volume surgeon doing other procedures as well next to the hypoglossal stimulation of the Genio procedure. So we see that this varies between 1-month to 3 months before those patients are getting implanted.

Okay. That's helpful color. And then maybe just to pivot, John, pro forma for the European second tranche I think you've got about EUR 40 million, call it, cash, the roughly EUR 26 million plus the EUR 14 million. Maybe if you can remind us what the breakeven point for the company is, your views on cash burn going forward? And then just to tack on the gross margin continues to perplex me. When I look at the P&L, when you guys had EUR 4 million in 2023, your gross margin was 62%. And here we are approaching EUR 40 million in 2026, and it can't get out of its own way in the sort of low 60% range plus.

So what is preventing gross margins from improving as the company has sort of improved the top line? And then how do we think about it going forward and sort of that inflection that you guys anticipate is going to take place in subsequent years?

Sure. So let me start with gross margin. So with regard to gross margin, we did have some issues with production yields in the quarter due to some turnover and some training issues, which have been all resolved at this point. So we expect to see our gross margins increase going forward beginning in the second quarter and for the rest of the year. I think, as I mentioned on the last call, we have our Genio 2.2 new disposal patch and activation chip, which will be a major step function improvement in our gross margin profile. That will be coming online in early 2027. So that will provide us that uplift from the low 60s to north of 70% at that point in time with that improved patient experience plus significantly cost reduced [ profile ] as well. So that's how we're thinking about gross margin.

Then also in terms of the next step-up in gross margin improvement will be driven by the cost reduction on the implants, which we have contractual volume-based pricing as we hit different volume milestones in our contract with our contract manufacturers. So that's the gross margin outlook and that we have a high degree of confidence we'll get to 8-plus percent in our gross margin profile on the back largely of those two initiatives.

In terms of cash burn, we're very focused on managing our cash burn. So as you can see, we held our cash operating expenses actually slightly decreased them from the fourth quarter to the first quarter of 2026, and that's reflective of the incremental 15 sales reps that we added in the U.S.

So we've been very focused on making sure that we're investing strongly in the U.S. commercialization efforts, reallocating capital to that from other parts of the business and really want to basically extend our cash runway as long as possible while supporting the investments in the U.S. commercial organization, which is the growth engine for us and not sacrificing the improvements in gross margin drivers. So that's how we're thinking about it.

As we think about cash operating expenses going forward, we will be -- we mentioned a 5% to 8% sequential increase this year. We would expect somewhat similar increases going forward, although we're not providing guidance, but as we're thinking about it, we want to be very mindful of our cash operating expense. That way, we can get to a revenue breakeven point approximately EUR 150 million in revenue, that allows us at that point to have an 80% gross margin, margin plus through tight cash OpEx management that to get to breakeven and knock down the total cash that we need to get to that point to somewhere in the range of EUR 100 million to get there. So that's how we're thinking about it and looking at managing our P&L levers that we have available to us.

[Operator Instructions] Our next question is coming from the line of Suraj Kalia of Oppenheimer.

John, can you hear me all right?

We can hear you, well, Suraj.

Congrats on a strong start to the year. Olivier, I want to follow up on John's question earlier, right? Your Q2 guidance, U.S. guidance is plus 25% to 30%, 241 patients in the queue as of the end. Obviously, you guys are going to add more patients as Q2 works its way. If we assume 100% approval, just the patients at the end of Q1 would imply about $6 million in U.S. revenues, and that's a 50% sequential jump.

So maybe you can -- if you could thread the needle for us as to what are your core assumptions here? Also, Olivier, maybe, John, in terms of your Medicare patient funnel, what are your expectations for the full year? And I have a follow-up.

Yes. So Suraj, let me start by commenting on the first part of the question. And I think you're totally correct. So we are seeing a strong ramp-up. And I'm not going into Q2 already, but it's clear that with the patient funnel and the pre-authorization in place and also the spillover from Q4 in Q1 and from Q1 and Q2, we already saw this translated in a very strong April. So that is correct.

Now how fast will we continue ramping up further? Again, as I was mentioning, it will all be also defined by the surgical time, the time that we can get because once again, we are working with high-volume sites and high-volume surgeons. But to your point, April already very strong on this one, and it's showing already that the ramp is kicking in.

The other part, I will turn it over to John to answer this one.

In terms of the ramp, I think we're looking at, again, stepping up the ramp in the back half of the year with regard to sequential quarter growth. So as we think about it, first -- second quarter, we're looking at 25% to 30% sequential growth and bumping that up to low 40s and then upper 40s, pushing 50% in the fourth quarter to get to our total number for the year. So that's how we're thinking about the staging of that, Suraj. Hope that answers your question.

And then the Medicare percentage that was the last part of the question. So in Q1, it's around 10% to 12%, still not a minority. We also see that this will continue growing and we are scaling up. And I do think that towards year-end, this will also be more in the range of 20%. But our commercial payers will stay predominant, will be the biggest part of the business, but also with the C-coding in place, I do think that is also completely derisked.

And we already had the two first [ MACs ] that I were very positive, integrating all the C-codes in their policy as well. So we are looking with a lot of confidence into the next quarters of 2026.

Got it. And Olivier, in terms of Genio and Inspire V, what is the dynamic in the field in terms of selection of the device? Because a lot of sites have these Inspire days booked I guess what I'm trying to understand is, do you all see any early signs of patient selection migrating towards Genio? And by the same token, how do you squeeze your way in with Genio? Is it displacing an Inspire case on these AGNS days? Or help us understand the dynamic as it stands currently?

Okay. So Suraj, that was also one of the reasons we recently conducted a market research study with 100 U.S. AGNS implants also to, in fact, do a sanity check whether our launch strategy and more specifically also the referral strategy is really the right approach and is making sense that impacting -- and it was really to our pleasure to see that I do think we can say that by involving sleep physicians in the management of patients, and that starts with patient selection, so CPAP quitting patients, but it also continues post-surgery in patient management. And what we are doing, we go even one step further. When we train physicians, we do not only train surgeons.

We combine this surgeon training together with their sleep physician partners. Now the dynamics between competition and Genio, it's also clear that for now, our investments in DTC are extremely limited. So the majority of patients that are arriving in hospital, they are coming for an AGNS solution, but they are not coming to DTC or Genio at this moment. So where the convert takes place is when they are in the site, and they are explained the different optionalities that currently are, we see that there is already a high percentage that automatically or spontaneously goes to Genio driven by not having an implanted battery, driven also by the bilateral station and software upgrades. So those are the main components that was confirmed in our market research as well.

Now going forward, we will continue focusing on sleep medicine involvement. We see also that we did the first therapy and the first patient activation that this is going extremely fast -- that we don't need to search to find the correct titration that in the majority of patients, the settings are exactly the same as they were seen during the surgery. And this is also giving a lot of confidence to sleep physicians also to refer for the patients.

So if you combine all this strategy is focused on high-volume implanters. We partner them up with their sleep medicine from the beginning. Then we make sure that there is a clearly defined role in patient phenotyping by sleep physicians before patients are selected after clearing their sleep up. And we make sure the sleep physician is actively involved also in post-surgery patient management.

And then, of course, by seeing the first activations, also the ease of finding the correct titration settings, this is giving a lot of confidence. So we will continue with this strategy, and we'll keep our DTC spending very limited.

[Operator Instructions] And our next question will be coming from the line of David Rescott of Baird.

John, I wanted to follow up on the comments around gross margin. I believe you said there was a production yield issue maybe in the quarter that has since been fixed or alleviated. And I guess depending on where you shake out for the year, I guess first part is, is that impact expected to continue into Q2 and then fully revert back in the back half of the year? And I ask that in the context of, again, where you shake out for the full year, you could be somewhere in the mid-60s by the end of the year if you're getting to the upper end of that 60% to 62% range. So just trying to get a sense for what the adjusted maybe cadence looks like as you get through the year on the gross margin? And then I had a follow-up.

Sure. So yes, thanks for the question, David. In terms of the gross margin impact, there will be a slight gross margin impact in Q2 because some of those units that were built in Q1 will run through our P&L in Q2, there will be a slight impact there. The rest of the year, we'll start to see it get back to where essentially we were in Q3, Q4 time frame, which was in the 63%, 64% type range from a gross margin perspective. And then we'll hang out there for the back half of 2026 before we implement the Genio 2.2 disposal patch and activation chip, which will again provide a step function improvement in the first quarter of 2027 up into the low 70s.

Okay. And then I guess just sticking on the P&L here, looking at this adjusted OpEx number for Q1 relative to the guidance for the full year, you annualize the Q1 number, and you're pretty much getting toward that low end of what the full year non-GAAP guide is. So just trying to get a sense for why we shouldn't be anticipating maybe a bigger step-up on a sequential basis as you go through the year on the OpEx line. Is it fair to assume that a lot of this SG&A investment is already in the business? Or is it more of a, hey, we'll step up SG&A as sales increase, but you now have some offsetting factors more on the R&D front? And then as that relates into where you step off when you look into the 2027 time frame?

Sure. Absolutely. So again, we've been thoughtful about managing our cash runway and being disciplined with our cash operating expenses. So from the large driver of OpEx growth is really regarding the investments we made in the U.S. commercial organization. Those have largely been made in the first quarter of 2027. So that will run pretty consistent over the course of the year, which leads to the essentially the 4x on Q1 results on the low end of the guide.

We will make selected investments over the course of the year, maybe being at the low end to somewhere in the middle of that range from an OpEx perspective. But again, we'll be thoughtful and disciplined in our approach there. And there are a number of items in the business that we made significant investments in 2025 across the board, across a number of supporting functions throughout the organization that we fully expect to leverage in 2026 as the organization scales using the existing infrastructure that's been built out in 2025, which then doesn't require incremental investments here in 2026.

So as we think again about 2027, we want to take the same approach into 2027 and try and redeploy as much capital as we can and leverage the noncommercial parts of the organization that have been built out and have the scale and capability to continue to support the business and redeploy that capital into the growth drivers vis-a-vis revenue and/or margin improvement initiatives. That's how we're thinking about it, and we want to be conscientious of that.

I think that was answering the question since the silent. So I don't know, operator, if there are more people lined up for questions.

That concludes today's Q&A session. And this also concludes today's program. You may all disconnect.

Thank you.

Thank you.

Good day, and thank you for standing by. Welcome to the Nyxoah Fourth Quarter Full Year 2025 Earnings Conference Call. [Operator Instructions] Please be advised that today's call is being recorded.

I'd now like to hand over to our first speaker today, Pearson Dennis, Investor Relations Associate. Please go ahead.

Thank you. Good afternoon, everyone, and I welcome you to our fourth quarter and full year 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 fourth 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, which will be filed with the Securities and Exchange Commission.

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 fourth quarter and full year 2025 earnings call. Let me start by our '25 key milestones and highlights. '25 was a transformative year for Nyxoah. We achieved several defining milestones during the year. In early 2025, in anticipation of FDA approval, we hired and trained our U.S. commercial team, including our first 25 sales reps. We developed our strategic launch plan, worked on securing market access and mapped out target accounts focused on the top 400 highest volume hypoglossal nerve stimulation accounts around the U.S. On August 8, we received U.S. FDA approval for Genio, followed by actively launching our product. We secured reimbursement for Genio across both Medicare and commercial payers, resulting already in first implants and revenue as early as September 2025. We successfully executed on our focused launch in the United States. We trained 145 surgeons in 125 high-volume hypoglossal nerve stimulation accounts, of which 57 already received positive value analysis committee approval, resulting in $4.5 million of revenue generated in Q4. This translates into $720,000 annualized sales rep productivity,during the first full quarter of launch.

From a clinical data perspective, the DREAM pivotal study was published in the Journal of Clinical Sleep Medicine. These data demonstrated Genio's clinical efficacy in both supine and non-supine positions as reflected in our labeling and differentiating us from competition.

Internationally, we continued driving growth in selected markets, including Germany, United Kingdom and the Middle East. We closed 2025 with a global gross revenue of EUR 11 million, driven by strong Q4 U.S. launch momentum.

Now let me dig in deeper, starting with our commercial update. The fourth quarter marked our first full quarter of U.S. commercialization following FDA approval, and we are excited with the first launch results. Let me share with you the key leading indicators that we are tracking to. As of December 31, 2025, with our 25 sales reps, we focused on 125 out of the 400 top HGNS accounts in the U.S. From these accounts, 145 surgeons were trained. We completed 120 value analysis committee submissions and received 57 approvals already with no VAC rejections to date. U.S. reimbursement has been consistent for Medicare and large commercial payers to date. For the past months, I've had the chance to meet multiple surgeons and fleet customers across the U.S., hearing consistent positive feedback on Genio's unique approach and the optionality we now offer to patients and physicians. Surgeons are attracted by the bilateral stimulation, the single incision procedure and the consistent therapy efficacy across all sleeping positions, which makes Genio unique on the market. In their interactions with patients, they highlight the patient-centric design, including the batteries-free implantable, full-body MRI compatibility and no need for resurgery due to battery depletion or software upgrades.

In addition, sleep physicians note that the first wave of activated patients in the U.S. are providing strong positive feedback on therapy outcomes. From a reimbursement perspective, ahead of FDA approval, we worked to align Genio coverage with the broad framework of hypoglossal nerve stimulation therapies across both commercial payers and Medicare. I'm pleased to report that Genio has been consistently reimbursed by both commercial payers, which represents approximately 90% of our business and Medicare, which represents the remaining 10% of the Genio business during Q4. Recently, there has been a lot of discussion and communication regarding HGNS reimbursement overall. As is typical for a relatively new product category, in combination with an expanding landscape where Genio enters the market, procedural coding practices continue to mature. In February 2026, CMS established new interim C-codes for HGNS that facilities will use when billing for traditional Medicare patients, including specific codes, 8011, 12 and 13, which apply to external power devices, including of Genio osystem. Last Friday, CMS indicated that the new C-code 8011 used for the Genio implant would be reimbursed in the hospital outpatient department at $31,526, in line with 2026 coverage for CPT code 64582. This also means that there is no reimbursement difference between the Genio system and competition. Staying with Medicare, the introduction of C codes does not change how surgeons build their physician fee for Medicare procedures. Surgeons are responsible for selecting the appropriate CPT code and potential modified use. Given recent CMS guidance, we expect surgeons will elect to use CPT 64582 for the physician fee.

Let us now to commercial payers, which represent approximately 90% of our business. Claims continue to be processed on the CPT Code 64582 or 64568, depending on payer policy, contractual terms, documentation and individual case review. To date, we have seen strong trial authorization outcomes across cases submitted to commercial payers, including many of the largest in the United States.

In conclusion, we view the current reimbursement agreement as a normal maturation of an established therapy. With the recent clarity on the facility fee of $31,526 for the Genio C code, we are confident that it will not have any negative impact on further Genio adoption in going forward. We remain actively engaged with specialty societies and coding authorities to support long-term dedicated HGNS CPT codes.

From an internal update perspective, while the U.S. is the growth driver, international markets continue to provide a consistent revenue contribution. Our goal is to ensure each of our international markets are profitable with Germany being the first that has achieved this goal.

In summary, entering the U.S. market in 2025, which is the largest HGNS market in the world, completes our transition to a commercial organization. The momentum we see in the U.S. launch reinforces our confidence in the opportunity ahead.

With that, I will now turn the call over to John for a detailed overview of our financial results.

Thank you, Olivier. Starting with the fourth quarter of gross revenue was EUR 6.3 million before EUR 700,000 of revenue deferrals, mainly due to disposable patches, which are delivered over time, resulting in net revenue of EUR 5.6 million compared to EUR 1.3 million in the fourth quarter of 2024. This growth was driven by our U.S. commercial launch, which resulted in approximately EUR 3.5 million of net revenue in the fourth quarter of 2025.

Gross margin was 64% in the fourth quarter. Total operating loss for the fourth quarter of '25 was EUR 18.6 million compared to EUR 18.3 million in the fourth quarter of 2024. Notably, operating loss remained relatively stable year-over-year despite significant commercial investments made to support our U.S. commercial launch.

Now let's turn to the full year 2025 results. Gross revenue was EUR 11 million before EUR 1 million of revenue deferrals mainly due to disposable patches, resulting in net revenue of EUR 10 million compared to EUR 4.5 million in 2024 or 122% year-over-year growth.

Gross margin for the full year of '25 was 63%. Total operating loss for the full year 2025 was EUR 83.5 million compared to EUR 58.8 million in 2024. The increase in total loss reflects the acceleration of U.S. commercialization activities in preparation for commercial launch.

Our cash position as on December 31, 2025, which includes cash, cash equivalents and financial assets totaled EUR 48 million.

Now as we turn to revenue guidance, we expect U.S. net revenue for both the first and second quarters of 2026 to grow 25% sequentially. This sequential growth in the U.S. reflects continued surgeon training, additional value analysis committee approvals and growing surgeon adoption. International revenue is expected to follow typical seasonal patterns.

With that, I'll now turn the call back to Olivier for closing remarks.

Thank you, John. For 2026, our priority is clear, continue executing on our U.S. commercial launch. To that end, we increased already our sales force by 15 sales reps and 3 sales directors in the first quarter of 2026, bringing us to a total of 40 sales reps, covering 200 of the top 400 hypoglossal nerve stimulation account.

During 2026, from a clinical perspective, we are looking forward to see our 12-month ACCCESS study data on complete concentric collapse and subsequent PMA supplement submission, potentially leading to a U.S. label expansion in early 2027. As a fast-growing company, we are expanding our internal manufacturing footprint to further strengthen our competitive position and improve our gross margins. We expect our 2026 execution to translate into a very strong financial profile as we gain market share in the U.S. Thank you for listening, and your continued interest and support for Nyxoah.

With that, I would now like to open the lines for questions and answers.

[Operator Instructions] Our first question comes from the line of Adam Maeder from Piper Sandler.

Congrats on the progress. 2 questions for me. The first one is just on some of the leading indicators or metrics that you shared Olivier, if I heard correctly, you have 120 VAC submissions that were made, I think, as of December 31, last year, and I think 57 accounts activated. Can you just kind of help bridge us for the remaining 60 or 63 VAC processes and kind of where those stand? When should we expect more accounts to go active? And just talk about the funnel for new accounts as we move towards that 400 of hypoglossal stimulation account target? And then I have a follow-up.

Thank you, Adam. So to your point, we have submitted 120 VAC submissions, already 57 are approved. The other ones, they will be approved, and we already saw the first ones being approved in Q1. As you know, not every hospital has the same time line when it comes to VAC approvals, but we were extremely pleased to see already the first 57 during Q4. So you can expect the remaining to start being approved during Q1. So that is already, I think, answering the first part of your question.

The second one is regarding to the sales force and how many accounts we are covering, many new accounts we will open in going forward. As I mentioned during my call as well, we already increased our hiring of 15 additional sales reps. So we went from 25 to 40. And with that, on average, each of those 15 will add 5 new accounts, so that can go up to 75 additional accounts, resulting in 200 out of the 400 high-volume accounts that we will be covering during Q1 and during also Q2. Hope this is answering your question.

Very helpful, Olivier. For the follow-up, I guess I'm going to ask about complete concentric collapse and the ACCCESS study. And if I heard correctly, I think you're targeting early approval in 2027. Maybe just help us understand when we're actually going to see that data presented. I assume that's this year. And if you could just maybe put a finer point on submission timing. I think that's a PMA supplement, but wanted to confirm that.

Yes. So yes, it is a PMA supplement that we will be submitting. Now coming back on timing, we had to wait for 12-month data. So by the end of June, we will have 12-month data of all patients. Then we will go into the analysis of the clinical data that will take up to 30 days. So by the end of July, we should really have a good view on the data are looking like and also using this to prepare our PMA supplement submission. There, we are confronted with the regulatory time line that we cannot really change and influence. So that's why we calculate it more or less 1 quarter, so 90 days, that we will do once we have submitted our data, and that's how we end up entering Q1 2027 to obtain the approval. When we will we publishing the data? I mean, this is something we have to submit. We will do this as soon as we have our data. So by somewhere July and then depending on the acceptance in the journal, we will definitely publish this data and present them during one of the congresses that we will attempt.

Our next question will come from line of Jon Block from Stifel.

John, maybe I can just start with you. I mean, obviously, helpful on some of the guidance figures. But any more color you can give us around the cash burn rate either for the quarter, 1Q even on an annual basis when we start thinking about 2026? And then I'll just ask a follow-up.

Sure, Jon. Thanks for the question. In terms of cash burn, we're looking at approximately EUR 20 million cash burn here in the per quarter in the near term. We -- recall in the fourth quarter, we raised capital vis-a-vis PIPE as well as convertible debt provided us additional cash to get into the first quarter of 2027. So with the capital we have on the balance sheet, and the cash burn, which, again, EUR 20 million here in the near term, which will decrease as we gain revenue traction here in the U.S. that will provide us the capital again into the first quarter of '27.

Okay. Got it. Very helpful. And then let me pivot. Olivier, maybe for you, maybe I could throw a couple of questions your way. The first 1 is, I think your compeititor has been pretty transparent about pursuing their own code and maybe going down that road for Jan 1 of 2028. I think the C codes bridge you for a little while, but your thoughts on pursuing your own code, what that will entail and what that may mean. And then can you give us an implant number, the number of implants that were done maybe as of the end of the year or any even color that you're willing to give us into 2026, because clearly, of those 57 accounts activated as you should be. I mean you're selling into the shelf a little bit when we start thinking about the revenue number.

Yes. Thank you, Jon. So yes, when it comes to the reimbursement coding, I'm finally pleased that we see that there is progress made that there is clarity also on the facility fee and that we fully understand what the use of Code or an interim C code means and how it's impacting also business going forward. Yes, also on the fact that we would like to evolve to our own coding, and there, we are following, in fact, the same pathway forward as competition is doing as well. And I do think listening carefully and interacting with AMA and also listening carefully to what is going on is that there will be a dedicated coding for Genio also in place, most likely somewhere beginning 2028. But in the meantime, facility fee is clear. We are now waiting for the physician fee, also although physicians and experts are telling us there that they don't expect many differences to how it used to be, meaning using the previous CPT 64582 coding also to calculate the physician fee. So that is one aspect.

Second, number of implants. We decided in our leading indicators not to communicate on the precise number of implants. But on the other hand, I do think it is relatively easy also to get a good estimate when you know that we generated $4.5 million of revenue in the U.S. in Q4. And you also know what the average prices is for the system being $25,000. So that's also, I think, an easy way forward to get your answer there. But in our KPIs, we don't give and we do not provide clear implants numbers. I hope this is answering your question, Jon?

Yes. Okay. I mean I get the math of the ASP and the revenue, and I can do that. But again, some are sitting on the shelf, right? So you were previously giving implants. I guess I'm trying to just get more granular on how many implants were done, not how many units were sold, of which a subset is sitting on the shelf. But I could follow up with you offline.

No, no, but I can -- I think it's an important question and topic that you mentioned. I do not want to avoid this. So first of all, it's clear that we have no policy in putting products on the shelf. We also clearly don't do any consignment. I just want to point out that there is also no consignment. And the way we -- our sales force is operating in the field on business. When we train surgeons, they come with pre-identified patients. Once they have these patients, most of the times, they are coming with 3 to 5 patients. And based on this, we make sure that we provide them with that number of implants, and we always at 1, maximum 2 implants depending whether it's 3 or 5 cases [ they're ] prepared so that there is some backup in case something will go wrong. And I think -- I hope to answer your question more clear in that sense, Jon, because I do think it's important. We are not lowering shelves. We are implanting patients.

Our next question will come from the line of Suraj Kalia from Oppenheimer.

Olivier, can you hear me all right?

Yes, perfect.

Perfect. Olivier, congrats on all the progress. Olivier, I just wanted to follow up on the previous question, so that I get my bearings right. Your competitors' key approach. I hope you can hear me, there's some background noise.

Yes, there's some police cars driving by. My apologies.

So your competitors' approach has been like to have minimum 4 to 5 units upfront sale when a new site is added on. And the larger sites, our field checks tell you can have 10, 12 implants on the shelves. So Olivier, when you say a new site comes online with the 3 identified patients, is your approach also really about 4 to 5 unit upfront sales, really for that matter? That's the right way to think about it. And by the same token, I'm curious how in the high-volume centers as LivaNova also comes online, do you think this dynamic is sustainable of respective inventory of each player on the shelf. I know it was a long question. Hopefully, you've got the gist of it.

No, I will start by answering the first part. So as I was saying, we treat patients, and we do not want to load shelves. I keep insisting on this. And with the example that you used, when we have 3 patients that are lined up for implants, we are selling 4, maximum 5 devices depending on what the surgeon prefers as a potential backup. So that's what we are doing. So we are not additionally selling more devices that are sitting there on the shelf. We are not doing this. So I do think your calculation in the example was correct, 3 patients lined up for implant. We sell 4, maximum 5, just to make sure there is some backup just in case. That is one aspect.

Second thing, you touched on LivaNova. So I was also carefully reading and hearing today's announcement, and I want to congratulate them with this. But it also means that they are not launching actively currently, but they are waiting till somewhere Q1, if my information is correct, or somewhere beginning '27 to launch. Now what we do expect, if you look a little bit at the technology is that you will have a clear differentiation, there is Genio, bilateral stimulation, external variable component, single incision, and then there will be 2 players with a pacemaker platform that will be more alike and most likely also more be considered when a compact physician in making patient choices or selection, which patients will get what. But I feel very confident with our Genio differentiated approach that we can continue also rolling out successfully in going forward and that patients also will know what to choose, a single incision with bilateral stim versus a pacemaker.

Fair enough. And 1 follow-up, Olivier. The 57 or so sites that you all have trained, Olivier, admittedly, it is early. But what are you seeing as the key driver for Genio in these sites? Like what is the key reason that physicians are asking, hey, I need this also on the shelves. And the reason I ask is, look, there have been a chatter about men with beards not having -- not wanting Genio so on and so forth. So just give us an idea about what you're seeing in the field to set the stage for market share approximations, at least between the 2 current players?

Thank you, Suraj. So maybe starting by clarifying something. So we have trained more than 57 accounts in the U.S., just to be very clear about this. we have already 145 surgeons and they represent or they're active in 120 accounts of the 125 high-volume accounts that we are targeting. So we're trained in 120 accounts, the 57 number is the number where we already have a full approval, where the VAC is approved, and where we actively were doing business during Q4. Just to clarify this one.

Then answering the question on why are surgeons choosing Genio, and I think you can summarize it in 3 major buckets. First of all, there is the optionality that we are providing by breaking the monopoly that was existing and not all patients like or accept a pacemaker. Second, there is the Genio differentiation. So a clear single incision implant technique, something that resonates extremely well with surgeons to having a single incision compared to multiple incisions. And then last, for the surgeon, also the bilateral stimulation and the related quality of airway opening with a beautiful [ tongue hold ] solution. This is something that we are hearing back constantly also with staying efficient in complex airway obstruction. So those are the 3 things. I hope this is answering your question.

Yes. Thank you.

[Operator Instructions] Our next question will come from the line of David Rescott from Baird.

This is Tommy Han on for Dave. I was wondering if you guys would like to put a finer point on your assumptions and guidance around new account adds versus increasing utilization in your existing accounts relative to the Q4 exit rate?

So as I was mentioning, we have a focused approach with the 24 salespeople starting immediately post FDA approval, we were able to reach 125 out of the 400 high volume. Today, we added 15 reps. So now we are already reaching out 200 out of the 400 accounts. Then next to this is we have already trained 145 surgeons. We have surgeons lined up for training. There are even a waiting list. So we are doing trading almost every weekend across the U.S., and we will also significantly increase the number of accounts we can do business with, and we can implant patients. So that can go up all the way to 200. But in the meantime, of course, there is each time the VAC submission that takes place, it is depending a little bit on by account by account, how fast it can go. We see that it can happen sometimes in 2 weeks, sometimes it takes a month, sometimes even longer. But what you can expect and gradually scaling up is that over time, and when I define overtime, by the end of Q1, we should be covering all the way up to potentially 200 implants accounts where w'ere present.

Great. And I was wondering if you guys wanted to provide a little bit more color around OpEx guidance and gross margin guidance for '26, and what the drivers are behind that? And separately, maybe for procedures performed so far, can you help us understand where those patients are coming from? Is it those who are expecting to get another HGNS device or more so people who have been waiting on the sidelines?

Yes. So I will take the last part of the question and the first part, I will hand over to our CFO, to John. So the last part, where those patients are coming from? It is clear that in those high-volume accounts, there are well-established referral networks, and we see patients being referred the moment that they arrive with the surgeon. So today, with Genio, there is optionality, patients are proposed both technologies, and we see that a high number of these patients are choosing for Genio, for the reasons I mentioned from a surgeon perspective. But when it comes to patients, what is driving them is that, in fact, Genio is designed, so patients can forget they even have an implant. So it's a very minimum invasive surgery, and it's also designed to [ evolve ] with patients. As an example, upgradable software, an intuitive patient app and no need for resurgery. So that is where we see a lot of patients being very appealed by when they're confronted and being proposed and explained what Genio can do. So that is one aspect. And going forward, it's also clear that we are establishing strong relationships with sleep physicians and that we are also working on referring our own Genio patients. John, with that, maybe on the gross margin.

Yes. Thanks for the question there, Tommy, on the model. In regards to gross margin, I would expect gross margin to increase slightly over the balance of the year, really due to increased sales volume and being able to spread the overhead over more units. So you'll see a slight increase in 2026 as we move through the year. The major step function increase in gross margin that you can expect to see is probably more in early 2027 when we launch our next-generation disposable patch activation chip or Genio 2.2 specifically, that will allow us to have an enhanced patient experience plus also allows us to significantly reduce the cost of the disposable patch going forward. So the next step function up. into, say, the 70% range will come in 2027.

In terms of OpEx, we don't provide specific OpEx numbers in terms of guidance, but let me give you some color here, if I can, to provide some direction. In terms of our R&D expense, which includes things like quality, regulatory, medical affairs, clinical, in addition to the true R&D spend, what you're going to expect to see there is that number to go down over the course of 2026 sequentially on a quarterly basis as some of the investments that we made in 2025, getting ready for commercialization will start to fall off over the course of 2026.

In regards to SG&A, the main driver there, Tommy, is really around U.S. sales expansion. So as Olivier mentioned, we expanded by 15 sales reps in 2026 in the first quarter. So you can expect our Q3, Q4 run rate to increase due to the increase of these 15 sales reps as well as their 3 respective sales directors. So that would be the major investments we make in the SG&A sphere this year, all the other infrastructure investments, we're going to leverage those as we build those out in 2025. So hopefully, that's helpful as you think about the model, and that's what we're looking at for 2026.

I'm not showing any further questions at this time. With that, this concludes the question and answer session. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.

Good morning, everyone, and welcome to the 44th Annual JPMorgan Healthcare Conference. My name is Varun, and it is my pleasure to invite on stage today Nyxoah, represented by their CEO, Olivier Taelman. Please put your hands together for Olivier.

Thank you. Let me start by thanking JPMorgan for the invitation. My name is Olivier Taelman. I am the CEO of Nyxoah. Nyxoah, a medtech company offering an innovative solution by neurostimulation to help patients suffering from obstructive sleep apnea. We are listed on both Nasdaq and Euronext under the ticker NYXH. Currently, we are going through the most exciting time in company history since we have obtained in August last year, FDA approval, and we are actively launching our product to help patients in the U.S. suffering from obstructive sleep apnea.

Our vision is to make sleep simple. Now before I will walk you through the technology, the commercial updates, et cetera, I would like to start by sharing how we at Nyxoah, how we see sustained value creation. Everything starts with the addressable market. And if you look at obstructive sleep apnea, it is a huge market. There are a lot of people, and we are talking up to 450,000 to 500,000 people that are eligible for the Genio technology in the U.S. only. That represents roughly $10 billion market opportunity. If we would have been in pharma, we would talk about blockbuster potential.

Next to this, it's also a largely underpenetrated market. Today, not more than 8% of the total eligible to treat patient population will actually get therapy. It's a fast-growing market. And we as Nyxoah, as I was already saying, we are currently actively launching as a second player in the space in the U.S. With Genio, we have a completely differentiated patient-first technology with a unique bilateral mode of action. I will come back to this later in my presentation in more details. Of course, we do have robust compelling clinical evidence coming from our clinical pivotal study called DREAM.

In the meantime, we already treated more than 1,000 patients outside of the U.S., across Europe and in the international business. We are commercially available in both Germany and U.K. and also recently in the Netherlands and in the UAE. And as I started my presentation by saying it is the most exciting time for our company because we are heavily -- we are intensively launching in the U.S. In the U.S., we already can also say that we have a reimbursement code secured, and we have both received already coverage from private payers and also from CMS.

Now before we talk a little bit more about why do patients need treatment when they suffer from obstructive sleep apnea, it also starts by touching a little bit further on what is exactly sleep apnea. It is a chronic disease. It, in fact, enable the patient during the night to breathe properly because they will have several collapses of the upper airway that can vary from 10, 15, 20, 30 all the way up to 60 obstructions of their upper airway every hour during the night. This all is categorized in mild sleep apnea, then we talk 5 to 14 obstructions every hour. You become moderate once you have 15 all the way up to 30 obstructions and you get to severe apnea once you have more than 30 obstructions every hour.

As you can understand and imagine, this is also associated with a higher mortality risk. And linked to the higher mortality, there is also the increased risk of comorbidities. And that is the main reason why patients suffering from OSA, as we like to refer to when we talk about obstructive sleep apnea, need treatment. The risk of stroke doubles, cardiovascular risk is going up by 5 and the risk of heart failure simply triples. Next to this, there is also a high prevalence in other key chronic diseases. I always like to highlight one. I'm sure you can see there are more than one, but I'd like to highlight one, and that is type 2 diabetes because up to 72% of all type 2 diabetes patients are suffering from OSA.

Also, there is a clear need to further invest and investigate clinically what the effect would be if we were able to stabilize the OSA of these patients during the night, give them back a good night sleep with a good oxygen flow, also on the glucose levels in managing their diabetic disease. But more to come on this one later. Now we know and understand why patients need treatment. But the next question is, what are the current existing treatment options. CPAP, and I'm sure you all know someone who is wearing a mask, a CPAP mask still is the golden standard in the treatment.

Next to CPAP, there are mandibular advanced devices. What we see with the Mandibular Advanced devices is that the predictivity of the efficacy of the therapy is rather low, and we also see that it's associated with a high out-of-pocket cost for patients. When we talk about CPAP, I think there, the biggest issue is compliance. There is a patient quitting percentage going all the way described in literature from 29% all the way up to 83%. On average, we see that up to 50% is quitting using their CPAP on annual level.

Next to the CPAP and the Mandibular Advanced devices, there is traditional surgery. What we learned with traditional surgery is that it's highly invasive. It's an extremely painful surgery or more specific the recovery after the surgery. The success rate is rather low, 30% to 60%. And we also are seeing that it's reoccurring. So once you have surgery, over time, you will be in need for again having surgery. And we're also seeing that with the younger generation of ENT surgeons, this is no longer applied so much.

And then, of course, there is unilateral hypoglossal nerve stimulation. Unilateral hypoglossal nerve stimulation, today, it's associated with an implantable battery, a kind of pacemaker platform technology. And just by saying this, this is already one of the hindering factors that patients will get a battery implanted on the chest, and that goes hand-in-hand with MRI compatibility restrictions. Now -- these are the options. And as you can understand, there is a clear need for a totally differentiated patient first technology. And that is the gap that we are filling with our Genio technology.

A little bit more details on Genio. So first of all, the Genio technology contains 2 key components. You have the implantable or the implantable stimulator as we like to refer to, and then there is the smart wearable component. If we focus a little bit first on the implantable stimulator, and you can see it on the slide, bottom right, you can see that it's a very elegant device. It offers bilateral stimulation. So we have 2 peddles, a left and a right peddle. There is no implanted battery. The technology of the implant is totally passive, and that brings immediately a huge advantage for the patient that it's offering them a full body MRI compatibility.

Next, driven by the bilateral stimulation, we also learned that we are the only company with a clearly differentiated clinical evidence showing that we maintain our efficacy also with more difficult airway obstructions. But I will touch a little bit more on this once we are touching the clinical evidence in the upcoming slides. Single incision, minimally invasive. It takes less than 60 minutes for the surgeon to implant skin to skin. After the implant, that is done in a daily hospital visit, you come in, in the morning, you leave the same day, less than 60 minutes, as that was already mentioned, patient goes back home, the wound or the incision is healing and roughly 5 to 7 weeks later, the patient is coming back to get the technology activated.

And in order to activate the technology, we are talking about a smart sleep wearable. Again, as you can see on the drawing, the patient is wearing his sleep wearable under the chin. It is attached to the body with an adhesive. In the morning, of course, the adhesive is removed and the wearable component will be charged and will be good to go for the next evening. If you compare this with a CPAP mask, if you compare this with a pacemaker technology implant, I'm sure you all agree that this is the most elegant and also the least invasive solution that currently is available on the market.

I was referring to a smart sleep wearable and why is it smart? It is smart because it is containing the software or the intelligence of the system, which is providing control for the physician when they start programming, but it's also providing a further optionality for patients once they are implanted. It's also capturing the data that patients are getting and also the impact on how they get their sleep quality back.

Next, it's also containing the battery. So the implantable part, as I was referring to earlier, is a total passive device that is activated once there is true induction and energy transfer coming from the smart wearable, activating the device once patients are sleeping. Now next to the wearable component, the patient also has access to what we refer to as an intuitive app. And what can they expect from the app? First of all, it's monitoring them during the sleep. Next, that it's capturing data, data that can be sent back to the physician, data that can be sent back and used by the company to further innovate and data that can even be used for health care economic figures to also see what it means when you start treating patients and you give them back a good night sleep and to give you one of the most obvious examples also how patients are returning to work or no longer suffer from daily sleepiness.

And then last, there is even the option for a patient to personalize his or her stimulation. And when I'm saying this, it is in predefined boundaries, of course, always controlled by the physician, but it gives them a little bit more option to find their optimal comfort. And by doing so, we are really empowering the patient and definitely it helps driving compliance. Just to give you some background on compliance, we already recorded more than 87% compliance data from patients and also 92% patient satisfaction.

Last, and I think also not to be neglected, people suffering from obstructive sleep apnea, they move, they travel, they want to go out with friends and family. So if you look at the device that they are carrying with them, it is the wearable component, weighting less than 12 grams. And you also have the charging unit comparable in fact, like sometimes when you put your phone in a charging unit. We have an implant for life concept, meaning that the implantable stimulator who is ceramic encoated, guarantees already a longevity of 15 years.

And that is only what we measure today. So it definitely doesn't mean that the device will stop working after 15 years, but that is what is reflected in the label. So that is the implant for life concept we refer to. And then there is a scalable technology platform. I talked already about smart wearable. Now what is the key advantage of a smart wearable is that there is no longer need for resurgery when there is, for example, a software upgrade available. The patient can simply have this push through to the smart wearable, a little bit comparable like what we do with smartphones when there is an upgrade available.

All this, I hope you agree, is bringing back to a totally differentiated, but patient-first technology. Now once we describe the technology, I think the next thing for a med tech company, which is crucial is building robust clinical evidence. So here, we have our pivotal study that was conducted in the U.S. We call it and refer to this as a DREAM study. It is published in the Journal of Clinical Sleep Medicine. And the 2 major outcomes that I would like to share already in the beginning is safety and efficacy.

When we look at efficacy, it's clear that we touched our primary and secondary endpoints in both the responding rate for the AHI, apnea hypopnea index and also the oxygen desaturation index. So there, we see results up to 64% and more than 71% for both. So the conclusion is Genio reached its primary and secondary endpoints in the clinical pivotal study.

Now from a safety perspective, which is also important, you see an overall serious adverse event ratio of 8.7%. Now putting the 8.7% a little bit in perspective, comparing with other neuromodulation solutions, there we see that it's a very low severe adverse event rate because on average, we see SAEs between 15% all the way up to 22%. So with 8.7%, I think it's clearly linked also to the fact that we have a single incision procedure that is also associated with less adverse events. If we look at the most common AEs, they can be brought back to the fact that it stays the surgery with an incision of roughly 4 to 5 centimeters in the chin fold, but we also see that those side effects that they are vanishing roughly 2 to 4 weeks post surgery.

So conclusion on this one is we have compelling evidence and we reached both the safety and efficacy primary and secondary endpoints. Now what is important for patients? And what is important for physicians when they are offering or making, in fact, the choice for their technology. What is crucial is, of course, that you get rid of your obstructions that you get back to a normal sleep. And what we are seeing is that we have a median AHI reduction after 12 months of more than 70%. I was mentioning that with Genio, we are the only ones who can guarantee also an efficacy in more complex airway obstructions.

And this is what you can see in this clinical study also when patients are sleeping on their back or in a supine position, we can also guarantee a very high reduction of airway obstructions all the way up to 67%. And then last for a patient, it's crucial that you are protected from your comorbidities, your risk for stroke, your cardiovascular risk. And we see that 82% of all patients treated with Genio, we are able to bring their AHI back below 15. And why is this 15 such a magical number? Once you are below 15, in fact, your morbidity is related or is exactly the same as people who are not suffering from obstructive sleep apnea. And that's what Genio can offer in 82% of all implanted patients after 12 months.

That brings me to the next chapter in our company history, and that is commercialization. So when we look at commercialization, we did our commercial proof of concept in Germany, in the international markets. And I will keep it also very high level. But what we did is everything starts by obtaining reimbursement for your technology. In Germany, we managed to get reimbursed, but not only reimbursed, we got exactly the same reimbursement as competition, which gives us immediately the big advantage that we can differentiate on technology and that we will also, through the reimbursement, will align on pricing.

Now the next commercial strategy that we applied was how can we enter the market as a smart follower, meaning we go where there is already a lot of experience with hypoglossal nerve stimulation. We position our technology, and we see how the uptake is and the embracement of Genio with surgeons and patients. And guess what? By doing so, in less than 24 months, we were able to capture 25% market share in high-volume competitive centers where we simply entered and positioned our technology. We did not invest at that moment in any DTC activities. It was mainly driven by giving surgeons, physicians and patients optionality and option to choose. It resulted already in 25% market share in high-volume competitive sites.

Now next, we are selectively expanding internationally. Next to Germany, you have the surrounding countries like Switzerland. We also started in '25 in the U.K., in the Netherlands, in UAE. But our aim stays focused on the U.S. and why? Because the U.S. today is simply representing the largest market opportunity with close to $1 billion of sales already coming from hypoglossal nerve stimulation.

And that brings me to the next slide, how do we enter the U.S. market. So we took the learnings internationally under our belt. We kept going for a smart follower strategy with a focused launch where we are focused on 2 key pillars. One is the high implanting ENT surgeon. We learned that in the U.S., you have approximately 400 sites that are generating 70% of the total HGNS revenue. So that's where we want to go and where we will, in fact, be present.

The next thing that we also saw was that patients are referred by sleep physicians or sleep pulmonologists to be more precise. And what we did and differentiated also from competition is that when we train our ENT surgeon, we do this hand-in-hand with their key or their most largest sleep physicians by bringing them together to the training, discussing patient phenotyping and then making sure that also the sleep physician understands what his or her role is post implant.

We have Nyxoah dedicated commercial team. Today, we are roughly 60 people. Of the 60 people, we have 40 territory managers, sales reps, whatever you would like to call them, we like to refer them as territory managers. And with those 40, we can already cover 200 high-volume sites in the U.S. out of the 400 high-volume sites that are existing. Our plan is to scale up on a quarterly base and to each quarter add a cohort of new territory managers so that by the end of the year, we can cover all 400 high-volume sites in the U.S.

Next to the territory managers, we have a dedicated market access team that is focused on helping also on the reimbursement preparation with the hospitals that also helps in the value analysis committees preparation. There is also a small marketing team. And of course, there is a field training and education team that is ensuring high-quality implants and also helping sleep physicians with the correct patient phenotyping.

Reimbursement has been a hot topic in the last days. There was a lot of questions around reimbursement. What we did at Genio is we start preparing our reimbursement already in 2024. And I'm happy to say that we have established a CPT code 64568 that is recognized by payers for HGNS. Today, when we look at the commercial payers and just to quote a couple of the big names that already reimbursed our technology, Blue Cross Blue Shield, United, Anthem, Cigna. So far, we have 100% acceptance of all the pre-authorization files that we have submitted.

And if we look at CMS, also there, we can say the same thing that we have obtained reimbursement from the majority of the MACs already where we did our submissions. So I do think we can conclude by saying that we also derisked the reimbursement. I'm coming -- I'm getting close to the end of my presentation, but I do think it's very important to share with you what you can expect from Genio and from Nyxoah in going forward.

And I would like to start in the middle of the slide with FDA approval. Once again, we have obtained this in August last year, and we have just released our first full quarter of results in the U.S. And I can tell you, they were extremely exciting. Extremely exciting, we see that we have trained close to 150 surgeons. We have happy patients. We see the patients that are activated already reaching out to their surgeons saying how pleased they were and how happy they were that they have chosen for Genio.

But in going forward, we also invested in a clinical study, very much focused on a specific patient population called CCC or complete concentric collapse patients. They represent roughly 30% of the entire OSA patient population. And currently, they are contraindicated for HGNS. With Genio, we already have them on label, so we are treating them outside of the U.S. In the U.S., we just closed the enrollment in a trial that we called ACCCESS. We will be showing 12-month results in June this year, and that should also result into a label expansion for U.S. patients as well suffering from CCC. There is further geographic expansion. And then, of course, there is innovative leadership.

So today, we are actively investing in incorporating the learnings and in making sure that by enhancing and advancing our technology, we can even continue increasing the respond rate with Genio. We are looking at the wearable component to make it even more patient ergonomic. We are looking how can we further stimulate different nerves like the Ansa Cervicalis stimulation, for example, also to increase the current patients that are not yet responding to hypoglossal nerve stimulation. So a lot of excitement ahead of us.

And my last slide, and I'd like to start -- or I'd like to end with the same slide as I started with, how do we believe of Nyxoah's future success in creating sustained value. Now obstructive sleep apnea, a huge market, $10 billion market opportunity in the U.S. alone, underpenetrated, fast growing. Nyxoah entered as a second participant, and we are breaking a monopoly, a differentiated technology. So we are bringing optionality to patients, and we see the first very successful momentum built in the U.S. We have evolved as a company from a clinical stage all the way into a fully commercial global public company. We are definitely not experimental because we already treated more than 1,000 patients in Europe.

And then, of course, you have the FDA approval that is finally unlocking the Genio potential for U.S. patients. We shared our numbers on Monday. And as I was saying again, I think we have beaten all expectations in the first quarter, and we do realize that it's just a start. But as we like to say, it's better to start strong than to start weak, and we are extremely excited in looking forward what 2026 will bring. Thank you for your attention, and it was a pleasure talking and doing this presentation.

Thank you, Olivier. I think we've got a few questions that have come in online. and I'll read them out. So the first question is asking more about the initial U.S. commercial outcomes. Would you potentially want to make a comment on that? And are you pleased with what you've been seeing there?

Yes. So the short answer is yes. And I think I already alluded to this that the first full quarter, it was a pleasure to see all the excitement with surgeons. We have trained almost like 150 U.S. surgeons in all those high-volume implant sites. We have already sold in the U.S. in the first quarter, $4.5 million. We see the first positive patient reactions after being activated. So the short answer is yes. There is a lot of momentum, and extremely excited.

That's amazing to hear. The next question we have is, who are the typical patients who are getting Genio? And are there any specific patient demographics that stand out at this point? Are the patients asking for the device? Or is it more of the physicians steering the patients towards the device at the moment?

Yes. No, and it's an excellent question. So first, who are the patients that we are seeing. It starts by what we refer to as low-hanging fruit. We have a high number and that it goes from 15% all the way to 20% of patients that are simply saying, I do not want to have an implanted battery on my chest. I don't like this at all. So they have now the option to go for Genio. So that's already a first group.

The second group are the patients who are saying, what about clinical evidence? What about the fact when I sleep on my back? What about the fact when I have a lateral wall collapse, can I be protected? So that's the second group, driven by clinical superiority, if I can say it like this. And then the third group that we are seeing, it's more linked, in fact, to the elegance or the minimum invasiveness of our technology. And there, we see women that are saying, I don't -- again, do not want to have a visible scar on my chest.

Summer when I go to the beach, I don't want to be looked at as someone who has a pacemaker. We also see younger patients who are saying, I do realize what it means to get an upgradable platform. I don't want to go back to the hospital. I don't want to be explanted and implanted with something new in order to -- just to benefit from software upgrades. So that's also what we are seeing. And then, of course, last, and I think it's also part of the question, we see that when a physician is giving the patient the choice by showing actually the 2 available technologies, we also see that spontaneously Genio is winning this.

I think -- and one of the questions that I have personally as well is based off of your presentation, when you mentioned type 2 diabetes being one of the comorbidities or the issues that do come up with it. So then the question then leads to the GLP-1 weight reduction drugs. What role do you think that they play when it comes to sleep apnea? And how do you think about potential near-term and long-term impact of GLP-1s to the specific space?

Yes. So from day 1 at Nyxoah, we have been saying that we welcome GLP-1 to our space for the simple reason that it will further expand the eligible to treat number of patients. And why is this? If you look at clinical evidence for hypoglossal nerve stimulation, we see that we are extremely efficient or if he has -- when the BMI is limited up to 32. That's where all the clinical evidence is taking place.

Now with GLP-1s, we are going to the extreme obese patients with BMI of 35 all the way up to 40. Those patients, we would never be able to treat until GLP-1s came in play. So what we are seeing is that by losing weight, there is also a direct correlation on the severity of OSA, but we are seeing that the new patients coming in with a BMI up to 32 are still in need for treatment. And that's a complete new cohort that we would never be able to touch if there would not have been GLP-1s. So there is -- I think there is a short-term, midterm and long-term positive effect on GLP-1s.

Perfect. I'll just quickly check in the room if there are any questions in person. Otherwise, we can continue with the online questions. Perfect. So the next question that we have online is regarding reimbursement, are you still tracking to 100% prior authorized approvals? And how quickly is the prior authorization process going?

Yes. So I think it was one of the most heated topics during JPMorgan when it came to HGNS. I can confirm what we also were saying in the beginning. We started building our reimbursement strategy already in '24. We followed the correct traditional path working with the medical association, AAO. Then there was a recommendation made by AMA to CMS. CMS accepted coverage. Today, we are in policy for this. And so far, we have seen both with private payers as with CMS, a 100% exception.

So for us, the way we are doing this with private payers, we work with preauthorizations. With CMS and with local MACs, we work with manual reviews, which is a little bit comparable to preauthorizations. And we have seen no change, in fact, in how we ended the year in the month of October, November, December. So for us, so far, so good.

Next question is, when do you expect FDA approval for the complete concentric collapse indication?

Yes. So first of all, we need to have 12-month data. These data we will have available in June. Based on this, it will take a little time to analyze this and to put it in the correct format to submit to FDA for a supplement and for a label expansion. We do think that end of Q4, but most likely beginning Q1 in '27, we will have this on label as well.

And how should investors look at the rest of the Nyxoah pipeline?

Yes. So as I was mentioning, we have a scalable technology platform, and we do put the patient first. So in going forward, we are coming with our second generation of wearable component. What does it mean concretely? It means that we are adding features to the -- to the smart wearable component in order to even capturing more live data.

Next, we're also investing in increasing our gross margins by having a new -- how do you say this, a new adhesive where the disposal or where the smart wearable will be connected to, that will have a direct positive impact on gross margins. So that's what investors can expect in 2026, also into 2027. And then more on the longer run, of course, we are further exploring how we can make our system even more intelligent, how can we integrate AI, for example, in capturing data, eventually resulting in a complete smart system that knows when to activate, knows what waveforms to use when and also maintaining, protecting patients really in function of their specific needs.

And do you have any update on the Ansa Cervicalis pipeline initiative? And where does the program stand today?

I mean with the Ansa Cervicalis, and I do realize that we are an early stage company, but we already looked at the future from day 1. So it's a collaboration that we have with the Vanderbilt University in the U.S. And in fact, what we try to do is we try to understand what it would -- what would happen if you stimulate the hypoglossal nerve and then you start adding on a second of a new nerve being the Ansa in order how this could help patients because there are still roughly 15% of patients that are nonresponders today, how we could help them as well and further expand the total eligible to treat patient population.

And I think this is the last question that we've got online is with the majority focus, and this was the prior slide as well on the U.S., what about your international business? And what are the key drivers for international growth that you see in the next 1 year?

Yes. So I think you pointed out correctly. As a company of our stage, we need to make strategic choices. And of course, the focus is the U.S. for a simple reason that it's a huge market, 97% of currently HGNS treatment or revenue is generated in the U.S., and we want to have a piece of this.

Next, internationally, besides Europe, we also entered the UAE. So we will be very selective. We will not go everywhere. But where we go, we need to fulfill a couple of criteria. First, it is obtaining reimbursement. Second one, having enthusiastic surgeons that we can train and also having the correct patients identified so that we can guarantee high-quality implants resulting also in high-quality patient outcomes.

Perfect. And with that, thank you so much, Olivier. Thank you for your time.

Thank you. Thank you for having me.

Good day, and thank you for standing by. Welcome to the Nyxoah Third Quarter 2025 Earnings Conference Call. [Operator Instructions] 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 feedback I'm hearing. Surgeons are enthusiastic to finally have 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 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 has 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 call -- 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 owe 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 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 onetime 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 sustainable.

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.

[Operator Instructions] 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 strong. Second thing that we are hearing as well that is always coming out is the fact that we offer a bilateral stimulation solution that is really 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, so 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 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.

[Operator Instructions] 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 about their technology.

[Operator Instructions] 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 pardon the background noise. I'm in the airport. So Olivier, of the current implants, admittedly, they are very -- relatively a smaller quantity, right? Can you give us an idea of where the initial appeal is? Is it women? Is it CCC? Is the lack of IPG target? 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-plus sites that you are targeting, I appreciate you walking us through in terms of CPT codes and whatnot that are getting through prior auth. Olivier, how is Genio being slotted from a logistical perspective? Because most sites of these high-volume sites have these "Inspire Days", right? And obviously, the push is on to ramp up Inspire V and put more. And is Genio slotted on Inspire Days? Or are you all seeing it separate at least 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 also the logistics in the hospitals. So once we are working through the VAC committee, it's clear that we see that in the high-volume accounts. Of course, we 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, 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.

[Operator Instructions] 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 get 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 and knowing that we -- in between, we had to get the VAC approval and we get 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 -- continue moving 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 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. And 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.

[Operator Instructions] 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 time frame. 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 don'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 here.

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. And 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 8-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 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.

[Operator Instructions] 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 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 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 ] go forward. So 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 work on 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.

Excellent. Thank you, everyone, for joining us. Before we begin, I'll give the standard disclosure. For important disclosures, please see the Morgan Stanley research disclosure website at morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative.

With that, thanks, everyone, for joining us. We are here with the CEO of Nyxoah. Thanks for being with us here, Olivier.

Yes. So first of all, thank you for having us and giving us the opportunity to interact and meet with investors, highly appreciate it.

Yes, absolutely. So maybe to kick it off, for those in the audience unfamiliar with Nyxoah, could you please provide a brief overview of how Nyxoah is changing the obstructive sleep apnea landscape?

Yes. No, no, definitely. So with Nyxoah, we are offering an innovative next-generation neuromodulation solution, more specific hypoglossal nerve stimulation to treat moderate-to-severe OSA patients. I do think we can say we have a totally differentiated technology driven by bilateral stimulation, single-incision implant.

Next to the bilateral stimulation and single incision, it's also clear that we go with full body MRI compatibility from the beginning for the simple reason that we do not have an implantable battery. When we look at the wearable component, so the piece that the patient will wear when he's or she is sleeping, the wearable component is containing the battery, but also the software of the system. And one of the big advantages when you do not have an implantable battery is that there is no need for resurgery when the battery is depleted, but there is also no need for resurgery when, for example, we have an upgrade in software that we want to push through that like that your iPhone, we can do this even without seeing the patient in the hospital.

If you combine all of these things, I do think we can conclude that we are very differentiated to what is currently out there, which is a base metric platform technology that we are looking forward to launch in the U.S. as it is happening today.

Yes, absolutely. We'll definitely hit on that. Before we touch on the launch, maybe could you talk a little bit about your DREAM study? You showed some pretty differentiated data. Could you give us the highlights and why they matter so much to patients and physicians?

Yes. So I think it's truly important that you have robust clinical evidence. So when you look at the study protocol of DREAM, so we had a primary endpoint, a reduction of Apnea-Hypopnea Index. So we had to reduce the number of events or obstructions with at least 50%, and we had to bring the overall number of events below 20. So those are the so-called Sher criteria.

Next, there is also the oxygen desaturation expressed in an oxygen desaturation index, where we also had to show a significant relief in the oxygen desaturation index. I'm pleased, first of all, that we met all primary and secondary endpoints. I think that's an important one.

Next, if you drill a little bit deeper and you look also what is important for the patient, but also for the physician and the selection coming from clinical evidence, I think -- and this is also supporting our vision in making sleep simple, a physician, he wants to have a safe product. So from a severe adverse events percentage, we had 8.7%. If you compare and put it a little bit in perspective also towards competition, it was close to 20%. I do think we have a safe product, and it's also driven by the single incision compared to multiple incisions.

If you go a little bit further in the efficacy perspective, there, I think it's important to see that, first, you can reduce, of course, the number of events, but also looking at the median reduction, important for the physician knowing what to expect regardless what the stages of events like if you have someone with extreme severe OSA, 60 events an hour or someone with more moderate OSA, 20 events an hour, what can you expect from a median reduction and there we showed 70%.

More important, we even showed 82% of people that we were able to bring back an AHI below 15%. And 15% is a little bit a magic number because below 15%, you're officially not in need for treatment. Once you go above 15, you become eligible for treatment. So 82% of all our participants, we were able to bring down to below 15, and that is great.

Then another one being ease of use for the physician is positional OSA. Very short, when you go in a supine position of sleeping on your back, the number of AHI can double and it can also -- and it will definitely significantly increase. We are probably the only company with proven clinical evidence that we maintain the same area opening as when you were in a non-supine position. That is also reflected in our label. And I do think for a physician and for the patient, important in their decision-making of what therapy they would like to have.

So those are more or less the big things that are coming out of the study, safe positional OSA, reduction of about 80% below 15%, and we hope that this is resonating well with the clinical audiences.

Yes, absolutely. And I think you mentioned your label. That obviously came fairly recently. We just got approval in the U.S. Can you maybe talk about the specifics of the approval and what it means for patients wanting alternative OSA treatment?

Yes. No, no, definitely. So we got approval on August 8, we'll never forget a Friday. We have been working quite long in order to get the PMA approved, and I'm extremely pleased that the team and the team integrated in achieving this.

Now when we look at our label, we see the position of OSA reflected in the label, but there is also another specific patient population with extremely difficult away openings to treat, and those are the patients suffering from complete concentric collapse.

It's contraindicated for current HGNS technology, but we already were able to show positive data in our Australian study. In Europe, we already had the notified body accepting this and adding to our label. And we see in the U.S. that we did not receive a contraindication. And that's already, I think, an important sign from FDA that they are trusting the data that we showed. And we are specifically also doing a clinical study related on CCC patients in the U.S. where we hope them to be able to further expand our label in the near future.

So those are, I think, 2 major differentiation points when you compare the Genio label compared with competitive labels. Next, what do we expect? I think nobody likes a monopoly to be very straightforward. When we talk to physicians, they like to be given an alternative, patients like to have an option to choose, and we are the ones who are breaking the current monopoly in HGNS. And I think that's very positively perceived because you have patients and it's measured up to 15% saying, I do not want to have a battery in my body. I refused simply to have this.

So far, there was no alternative, no, there is. So I think that's a good thing. We learned, and I think we can maybe talk a little bit more about this later, but also in our German experience that once you break the monopoly of 2 companies talking and positioning their technology in HGNS that you also see the overall therapy penetration increasing. And I think also that is very important.

Yes, absolutely. We'll definitely hit. I think you hit a lot of super interesting points. ACCCESS, we definitely want to talk a bit about that later. I'll definitely ask you about some of the German experience. But maybe now that you have the approval in hand, how are you planning on prosecuting the U.S. launch to make it as impactful as possible?

Yes. So we obtained on a Friday, the approval and on Monday morning, the sales team was launching. I think we took a little bit gamble by hiring already last year December, our commercial team. We currently have 50, 55 people to be precise in the commercial team. We have 25 different territory managers. We focus on high-volume HGNS implanting accounts and then the people are doing great.

We are now more or less 3 weeks after the FDA approval. We already have strong results in our leading indicators, number of surgeons trained, for example. We also went to the value analysis committees already with a high number of sites. We see the first approvals coming in.

Next, we are working with preauthorizations for PI for commercial payers also there, we have close to 20 already after 10 days of launch of preauthorizations that are submitted. We see the positive reactions with surgeons. So there's a lot of positive energy and people are excited.

Great. I think one of the things that we've heard in the way that you've set up your commercial strategy is that you're targeting primarily sleep physicians as opposed to ENTs, which maybe some people would say that should be the target. So why do you think that's the right strategy? Why target the sleep physician?

So first of all, I would like to highlight we have a two-pronged launch strategy where the ENT surgeons are playing an important role. On the other hand, we believe that a sleep provider or sleep physician is really central in the management of the obstructive sleep apnea patients. Very simple. They are the ones identifying in PSGs like how severe is the condition. They are the ones also working with CPAP as gold standard.

But they are also the ones that are seeing CPAP patients coming back saying, I'm looking for an alternative. I don't tolerate my CPAP, I'm about to quit, I want something else. So therefore, I do think it's a role in educating those physicians one on how to position, what is the correct phenotyping for successful Genio treatment.

But also second, and I think this is so crucial, what is their role in patient management post surgery. Because today, sometimes you see that they're a little bit confused, not knowing exactly what to accept and how to -- what to expect, sorry, and how to contribute.

So by educating and training them in how to stimulate patients, how to adapt stimulation, also how to gather data by working, for example, with home sleep test, seeing and evaluating the kind of technology and how well their patients are doing, will give them the option, first of all, to see themselves, what it can do to help also getting better in defining what is the correct and the best patient phenotype, but also to provide us with data that we can learn from and that we can also develop over time health economic data.

So for us, the sleep doctor has a crucial role and a central role in the patient management. The ENT doctor has more of a technical role in doing high-quality implants and making sure that we can do a lot of implants and doesn't need to worry in post-surgery management of patients that this is done by other experts. And that's how we see the future of HGNS significantly increasing.

Fair enough. So I think you said you've had the approval for a couple of weeks now. Pre-approval, we have heard that there is a lot of pent-up enthusiasm for Genio. As you look forward over the coming months, what are some of the key leading indicators you're focused on to sort of measure the enthusiasm translating into commercial success?

Yes. No, no, an excellent question. So first of all, we focused on the high-volume sites. If you look in the U.S., you have roughly 400 implanting sites that are representing around 80% of the total volume. So we want to reach those 400 as soon as possible.

With our current sales force, we can already reach 125. We will be scaling up every quarter. We are adding more sales reps. We were opening more territories. So from a leading indicator perspective, it starts with surgeons trained. Then we have the value analysis committees approving and accepting our technology, and there are the preauthorizations.

And then, of course, we call it a full active site where the surgeon is trained, where the VACs have approved, where we have patients identified. And that's all the leading indicators before we will start generating revenue and also start communicating on and giving projections on revenue and on plan is done.

Right. And I guess you mentioned the 400 high-volume accounts. How are you identifying those? And what would success look like at one of those accounts once you're in?

So how do we identify them and allow me to make a little joke, but sometimes it's nice to be second. I mean we have -- our competitor has done great work in developing and introducing HGNS and getting it covered. And sometimes when you come in as a smart follower, they have paved the way, and it's relatively straightforward to identify those accounts.

But there, you took an advantage. On the other hand, how does success look like? So I think successful in those accounts will be expressed in market share and market share gain. We started in Germany. We did get a commercial proof of concept. We were able to capture 25% market share in 2 years' time.

Not saying we will do the same thing in the U.S., but I do think it is an illustration that there is an acceptance for that there is a need for an alternative, and we hope to see this also in the U.S. So we will be having high-volume accounts and measure of success in revenue and in market share gain.

Fair enough. Maybe pivoting a bit to reimbursement. We know that can be for many medtechs, a hurdle early in their commercial life cycle. How are you managing your reimbursement progress and sort of how do you make sure that patients get the treatment they need?

So what we did is we looked at both the scientific and the medical organization in our case, the American Association of Otolaryngologists, the AAO. We worked very close with them and also educating them on what our technology is doing, listening to demo they are seeing the place. They are interacting with AMA.

So that was one aspect. The second aspect during the FDA process, we were also support of the early payer program that gave us the opportunity to present Genio in front of all the major commercial payers in the U.S., but there was also quite some educational work done. We know that there initially was a CPT code, 64568 that was used by, I will call them name by Inspire. They moved out of this code, but now they are coming back to the same coding because the latest technology innovation.

We just received the news from Medicare that this code is now also officially accepted as an HGNS code. We do the same mechanism of action. We have the same stimulation parameters. So next to the reimbursement, we, Genio will tap out to the same coding. So that will be step one.

With commercial payers, we will use with preauthorizations with the government payers, I can say, Medicare, we know that we already have several MACs that have accepted this coding and we already covered 1/3 of covered lives. So that's, I think, a good start. And the rest we will see when the preauthorizations going back.

Right. And I guess as we look forward, how will you measure success with payers? Is there a certain cadence of covered lives you're looking for? Are there certain milestones that we should be looking out for in terms of reimbursement?

So first of all, every time that we will have a preauthorization submitted and that is approved by a payer, that will help us scaling up, and we can then also start talking about covered lives. Again, also here, I think we can benefit a little bit from being the second mover because there was a lot of work done. And today, it is -- it was a nerve stimulation that has a coach and it's not a specific technology that has one. And that's why we think we will be able to scale up fast.

Yes. Fair enough. Maybe you mentioned Germany as a proof-of-concept market for commercialization. Maybe can you talk a bit about that experience and how you would think that translates to the U.S.? And maybe what parts you don't think are going to translate?

So first of all, I mean, outside of the U.S., Germany is one of the largest markets for hypoglossal nerve stimulation, but it stays underpenetrated and it is an extremely small market compared to the U.S. It was also not so intensively commercialized by competition.

That being said, there are similarities, and it's caused by reimbursement. So the first thing we wanted to prove is can we obtain a similar reimbursement to our competitor. So the answer was yes. We have exactly the same criteria.

Second thing we wanted to show is if we go to high-volume centers, are we able to bring the monopoly to bring the relationship and to gain significant market share. The answer was 25% in 2 years' time. The next thing is how can we drive sleep levels? So also there, we looked at sleep physicians.

We saw that we were struggling a little bit because the sleep physician in Germany is totally not well educated when it comes to HGNS, and they were seeing us as a novel therapy. That's how large the lack of awareness was. So there, we struggled a little bit, and we had to do some more focused DTC reaching out direct to patient organizations.

So the learning was education of sleep physicians, it is crucial. And then last, what we also were seeing in Germany is that the importance of also patient testimonials, people speaking on forums being positive about your technology. And also there, we have positive interactions. So that was the German proof of concept. Next thing since this year, we entered the U.K. market, where both competition and Genio entered at the same time.

I can tell you, there you see that we are so identified who will be the #1. And I think we have a little bit the lead after 6 months. And then last, we also wanted to explore the distribution model. And there, we are unique by entering in the Middle East countries. So we did our first implants in Dubai, in Abu Dhabi and in Kuwait.

And there also, we are learning what it means if we would go indirect. So those are the 3 eye-learning concepts. Germany, closest to the U.S. with differentiation. U.K. [indiscernible] at the same time. We show that we can take leadership. And then in the Middle East, we are the only provider to go indirect and also there we have...

Fair enough. And as you look at your experience in those 3 markets, is there any specific type of patient where you're more successful? Or what is the ideal patient profile that you're looking for that's really successful with Genio?

So it's a very interesting question because when you look at obstructive sleep apnea, the average age is roughly 53, 54 years old. So I hope those people live a little less 30, 40, even longer. So it's becoming almost like a lifestyle implant that we would like to promote in the sense that we have an implant for life, 25 years longevity.

We have a passive implant that is totally, but also the brain is external. So there is no need for resurgery anymore. And we want to also have people that are conscious about their health. I mean, if you have a BMI of 40 and you refuse to lose weight to be very straightforward and you want to not change your lifestyle, I mean, I don't think an implant or a drug will change your life.

There need to be some kind of motivation, especially in sleep. So we want to stay away from those extreme of BMIs above 35. We want to position ourselves for people who are conscious that a healthy lifestyle will also give them, I mean, not only more functionality, but also the aspect of not buying of comorbidities.

I think that is very important. And when you look at the perfect Genio patient, it's a female or a male 53, 54 years old, who are conscious about this and who also want to make an effort to stay healthy for the coming 20, 30, 40 years.

And I guess, in the vein of health, there's obviously a lot more optionality now for people above a certain BMI with therapeutics that might take them below a certain BMI threshold. How are you thinking about the evolving landscape in therapeutics, either expanding your funnel or not expanding your funnel? Or does it change the Nyxoah opportunity?

So the GLP-1 question.

Yes.

So what is the impact on this? So as I was saying, all of clinical evidence is done with the BMI limitation of 32. So that is where we know we can be very efficient and offer safe technology. So if you look at the GLP-1s in the SURMOUNT trial of Eli Lilly, the average BMI was 37.

And we saw clearly that the AHI was also very high, it was 50. So there is a correlation between the weight of the person and obstructive sleep apnea goes without saying. Now these results were showing that when you use a GLP-1 and you are a GLP-1 responder, you can lose up to 25% of your BMI. So the 37% becomes somewhere like back of 20, so 28, 29. The correlation with AHI was patients were losing, in fact, 40% to 60% of events. So 50 becomes somewhere in the 22 all the way to 28.

This is spot in where we have strong clinical evidence where patients are still in need of treatment and where they have demonstrated also their motivation to lose weight. So this assessment, we were unable to tap on if there would not have been GLP-1 because we are limiting ourselves at 32, and we do not want to take the risk to increase our BMI because I do think it will be a strategic mistake already with a young novel technology going to so extreme high BMIs that you could have a failure rate that will be higher, but it's not helping nobody.

So we see this as very positive. Will we lose some patients? Definitely. I call it more the cosmetic use of GLP-1. But if you see net-net, there will be more patients coming in from the extreme obese and high BMIs than patients were going out because of more the cosmetic use of GLP-1.

Yes. Okay. Fair enough. I think one -- maybe going back to a bit of the commercial side of the equation. I think if I'm remembering correctly, you mentioned over 100 trained physicians in your last earnings call. Can you talk a little bit about sort of the cadence of physician training and what the period was to train those 100 physicians and if we should expect 1,000 physicians in the next call if you trained over 2 weeks? Or how should we think about physician training?

So first of all, I would like to complement my training and educational team because they're doing a phenomenal job. Just to highlight how we do this, we [fly] physicians in most of the time on a Thursday, late afternoon. We start with a dinner where we also have discussions on what is the patient's phenotype, how should the perfect patient look like. We bring also sleep physicians in these trainings. So this is already this relationship building between the ENT surgeon and the sleep physician.

We start very early, 6:30 in the morning with a theoretical session. And then after the theoretical session, the surgeons go into the cadaver lab and they start learning how to implant. The sleep physicians, they go with our technical people learning how to program, how to stimulate, how to interact with patients, what to expect from a technology. And then we are all coming together for the light lunch and people are flying back.

The next group is coming in, in the afternoon on Friday. The next group is coming in on the afternoon on Saturday. And each time we have a physician group of roughly 12 physicians because with the cadavers that we are doing, we want to make sure we can guarantee the correct quality and 12 surgeons at a time is perfect, and we have weekend between 24 to 36 surgeons that are trained.

And how many of those trainings do you have to do to feel comfortable that you'll be able to successfully implant on Genio?

After the training, the surgeon is flying back to us of our hospital. They -- before the training, we have identified a number of patients so that they can start also actively implanting. We will send all the process to make sure that the first 2 cases have gone spotless. And what we see in the learning curve is that 4 implants is more or less a magical number that surgeons are feeling really comfortable. So -- and then they're off to a great start.

Right. Great. And is that -- are the 100 physicians, are they -- is it across centers? Is it multiple from a specific center? I know you mentioned there was a target of 25 in the near term. How should we think about either geographically, is there any specific place that you're starting...

So yes, we have a focused launch. So my marketing colleagues, they told me the word heat maps. So heat maps where you have the hotspots a little bit the large implant sites and also where the real network is coming from, we have mapped all this out. To my surprise, you're seeing that the East Coast is much more -- showing much more hotspots to this work compared to the West Coast.

Don't ask me why. And then you see that we have specific regions like, for example, the Texas region, where you have also in the Midwest. So what we are doing is with a focused launch, we have identified several of those hotspots, and that's where we start rolling out our technology.

Great. And how should we think about in those hotspots, are the VAC committees, how is that progress going? How should we think about this?

So I feel like we do in my entire business model. So first, we have the heat maps, you have the hotspots. Then we look at the VAC committee because there is also a huge difference in getting an approval from a VAC and it varies from 1 week to sometimes up to 8 months. So we put a second layer like in these hotspots, which are the ones with the fastest VAC committees. That's where we were Monday, August 11, 12, 13, 14. So that's the first one, resulting in the ones that are already having the approval granted to us, and that's how we will further expand.

Great. Maybe moving a little bit further down the P&L. So you mentioned you had hired the commercial presence back in December. So we should probably have seen some of that already rolling through the P&L. But what should we expect going forward in terms of OpEx, R&D, et cetera? Should we expect OpEx to ramp? How should we think about the cadence of OpEx?

Well, as I mentioned, we will be scaling up our organization, our commercial organization significantly every quarter. So that will definitely have an impact. And I'm looking at our CFO, but I will not be sharing concrete numbers. I don't think this will be wise at this point, but there will be definitely a scaling up when it comes to further building the organization.

Then you touched on something that we did not spoke about, but it's innovation. Although we are a small company, we put innovation as one of the top priorities going forward. in the vision of making sleep simple. I think we can further make progression in our implantable part. But for me, what is so important will be also the patient aspect.

And that part, I named something very simple. I would like to have every patient getting live feedback in the morning when they wake up in how their sleep quality was. We already have a patient app, but we can do much more on this. We can provide information about the ODI. We can provide information about the number of events. So -- and I do think that this will also increase compliance.

It will also make patients like owning their technology. And that's where we are investing in. In our wearable component, we are wearing sensors, for example. Because over time, I would love to have an implant for life that is intelligent that knows automatically when are you sleeping that can also adapt simulation.

And then on the other hand, I want to have a wearable component that is providing data to patients, but also providing data to health care providers and to us to continue self-learning to increase, in fact, the quality of our device. That's where we are investing in. And over time, if I look a little bit further, and I'm thinking 5 years down the road, I want to have a technology with all the wearable component that you don't even see when the patient is implanted.

And there we are thinking about pillow charging concept. So you would have your coil in the pillow, you would have a battery on the night stand and a closed-loop system. This is existing. We just need to roll it out. And here, I'm getting totally carried away and but that is what makes our platform so unique by having a passive implant. We never have to reoperate this patient. we can upgrade all of this without making another incision in the human body. And this is a [indiscernible] technology will never be able or capable to do this. And that's why I think we are in the next-generation hypogoserim, and this will resonate well with patients and with physicians.

Yes. No, absolutely. I did have a question -- actually, my next question was going to be about R&D and about the pipeline opportunities. So you mentioned the pill, you mentioned the intelligent design. How should we think about the cadence? You obviously have a ton of near-term just with the commercial. But as we look further out, 18 months from now, 24, 5 years from now, where -- what's the future hold in terms of next-generation devices?

So with our current technology, I'm convinced we are extremely well positioned to compete with what is existing. So then we will further expand in the CCC patients, representing 30% of the total population. So from an indication perspective.

Now if we go to a product innovation perspective, the implantable component, we are exploring how to stimulate independently. Now we do bilateral, but we can also do this independently. That will help us also treat more complex airways and give the physician more and more leverage.

The next thing that we will do is in the revenue component. So we are -- next generation is ready. It has a different shape. It follows more the shape of the chin, sorry. It contains a sensor. It will further develop the app and provide already and capture more data, as you can expect in roughly 18 months from now, it will be regulatory approved. And then the next step will be that we are going all the way to the and then we will be 23, something like that.

Yes. Wonderful. I think one of the things that you mentioned that I don't want to shortchange is you recently announced the ACES trial has reached a number of patients where you feel comfortable you're going to get good data out of it or a powered study, right? So can you maybe talk about what the ACCESS study will provide, what sort of clinical validation it will provide and what TAM it opens up for you?

Yes. So today, the physicians need to do a specific examination called DISE, drug-induced sleep endoscopy to whether identify if a patient has a complete concentric collapse or not. If they do, they are no longer eligible for what is existing on the market, okay?

So this examination is something that is cumbersome for physicians, but also for patients. And you feel a little bit as we say in Europe, like when you care the endoscopy she in your stat while you're still awake and you're a little bit under, but you are still awake and then they will see what happens with your airway.

This is something nobody likes. So when we designed the ACCCESS trial, we are also very straightforward. If you want to have an on label for CCC, you also need to make sure that the physician and if we go again make sleep simple and a physician can expect the same outcome for a CCC patient as for non-CCC patients. So the primary endpoints are identical as we have in DREAM. So that is one aspect. We had to implant 106 subjects in this study. I will not disclose the precise number, but we have a sustainable number where we believe that we have strong power analytic power to convince that this also should be on label in the U.S.

We have the data from BETTER SLEEP. We have a live experience in Europe. So we do feel comfortable. We also are seeing that FDA currently with other companies that are in the clinical stage are accepting like up to 30% of patients being CCC in a study cohort of roughly 100. We have significantly more patients than 60 to name a number in our ACCCESS study. And we want to bring also CCC patients a solution in SAP in the U.S. So we closed the enrollment. There is a 12-month follow-up that will be us next year around this time. And then we will do a PMA supplement submission, normally 4 to 6 months. So I hope that by the first quarter in '27, we can also have the label expansion in the U.S.

Wonderful. I think we have about a minute left, so I'll ask last question. What do you think is the most underappreciated part of the Nyxoah story that you would want everyone to know?

So I think that people are not fully realizing how differentiated our technology is and how bilateral stimulation will make a difference to maintain also more complex airways open. So that is one aspect. There is one thing I would like to say, and it's may be a funny anecdote in the last minute. But 3 years ago, we made the decision to manufacture in the U.S. for the U.S.

Today, with all the price discussions, it seems to be also a good decision. So I think that's also important. And then we are also having a manufacturing site in Europe for the international market. And I think in the last 30 seconds, the scalability of our platform, as I was already explaining a couple of times, I think this will benefit the patients so much. And I think that's crucial in managing obstructive sleep domain going forward.

Wonderful. Well, we look forward to seeing how you change the landscape of OSA. Thank you. Thank you very much for being here.

Thank you for having us.

Hello and welcome to Nyxoah Second Quarter 2025 Earnings Conference Call. [Operator Instructions]

I would 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 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 our second quarter 2025 earnings call. I'm extremely proud to announce that we received FDA PMA approval for our Genio system in the United States. This result was the culmination of persistence, 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 advance from currently available treatment options. For physicians, they now have a choice to select the optimal HGNS 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 by bilateral HGNS 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, 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 through 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 ACCCESS study. We believe that the number of patients enrolled in ACCCESS will have enough statistical power to draw meaningful conclusions on our effectiveness for complete concentric collapse patients. In addition, we see great results in realized data from patients in Europe where our CE mark 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 demonstrates a high level of patient satisfaction.

The device demonstrated compliance of 85.9% and the 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 neurostimulation implanting centers, where they will position Genio, 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 payors 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 Payor Feedback Program, educating CMS and major commercial payors on the clinical impact Genio 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 additionally 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 HGNS market. Contrary to our competitors, we have strategically limited our patient population to dose 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 SURMOUNT 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 HGNS patient population, this will be outweighed by a significant number who become eligible for HGNS.

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 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 equivalents 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 mode for Nyxoah. I would like to thank all Nyxoah employees for their persistence and efforts in making this happen. We have now officially entered the U.S. OSA market with our innovative Genio 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 call.

With that, I would now like to open the line for question and answer.

[Operator Instructions] Our first question comes from the line of Jon Block with Stifel.

Olivier, John, obviously, a big congratulations to you and the team. I'll start off, just any year-end '25 metrics? Leading indicators to focus on? Trained physicians? I don't know, I'll throw that one out there. I know you said you already have, I think it was over 100, [indiscernible] 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 3 or 4 months, where our eyes or where our focus should be as we think about exiting '25 in regards to the Genio launch?

Yes. Thanks for the question, Jon. 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-a-vis maybe 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. And then I'll sort of pivot, Olivier, this one might be for you. But just 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. So can you talk about how you expect to leverage the differentiated label 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, Jon, for this question as well. Yes, clearly, it was for us a very 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. And that is why positional OSA is so important that also there, we can continue showing a highly effective technology and therapy. And so far, Genio is the only technology that is offering this, so that comes to the supine data and the positional OSA.

When it comes to CCC, of course, there it is extremely encouraging to see that also FDA is recognizing this by not giving us a contraindication contrary to competition. And as you know, with ACCCESS, so there, we also did great work. We had our PIs implanting a significant number. So now we can close -- 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.

So both are reflected in the label. I know that you and many of your colleagues have questions on this in the past. And 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 HGNS technologies.

Our next question comes from the line of Adam Maeder with Piper Sandler.

This is Kyle on for Adam. 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 kind of centers from the DREAM study, some of the high-volume implanters? Can you just give us kind of any color around the accounts and the strategy there?

Yes. No, no, definitely. So as I mentioned in the script, we have a two-pronged approach. So first of all, we go and our sales team will focus on high-volume hypoglossal neurostimulation implanting accounts. Maybe as a quick reminder to this, you know that in the U.S., there are roughly 1,400 implanting accounts offering HGNS, but it is a very concentrated market, meaning that 350 to 400 of these are high-volume accounts and are representing 75% to 80% of the total revenue. So 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 4 to 6 of these accounts. And we have built what we call a scalable technology. So every quarter, we will add a number of territory managers and increase the number of accounts that we can cover as soon as possible, all 400 of those high-volume implanting accounts. So that is what we call our focused launch.

Next, and I think as important is also strengthening the referral part and the way we are doing this in that 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. And also, there focusing on those specific patient groups will definitely strengthen the trust and confidence of sleep physicians, and we'll also further make sure that patients in need for treatment will get a sleep surgeon that can help them with a Genio solution. So that's all we plan to go forward with our launch strategy.

That's super helpful. Maybe just for my second question, to shift over to reimbursement a little bit. Is there just -- how do you plan to go about that process here looking forward? Is there any logistical considerations around like the work that you're doing with the different payors? And then maybe more specifically, when can we expect to see some onboarding of some of the larger payors. Would it be fair by the end of this year? Or is it kind of more of a 2026 story?

Yes. Thanks, Kyle. I can take this question. So in terms of our reimbursement strategy, we have a comprehensive reimbursement strategy. So 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 Payor Feedback Program. And we've also been working with engaging CMS and major commercial payors in the U.S. around this particular code.

So 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. And then as we start moving into more of the coverage decisions, if you will, that will be probably more of a 2026 item, Kyle.

Our next question comes from the line of Suraj Kalia with Oppenheimer.

Olivier, John, can you hear me all right?

Yes, we can.

Gentlemen, congrats on the approval. I know it's been a long time coming and on the label. So Olivier, a quick one, let me start out. You mentioned ACCCESS enrollment has been stopped. I presume that the [ SMB ] chimed in and helped you reach that decision.

Yes. So when it comes to the ACCCESS study, in fact, we reached 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, 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 what is going -- what is happening in the OSPREY study. We know that the number of patients that we are having, we have already more than double the number of patients that they have in OSPREY where they're also looking at CCC patients. So that's just as a side comment, but I think important information for you to know as well.

And then 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 are doing in Europe in a very successful way, like we demonstrated in Australia in the BETTER SLEEP study. And therefore, here, we cannot wait. And 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 time frame. So 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 '26, beginning '27, also to add this to our label in the U.S. and be able to help CCC patients that are currently contraindicated for HGNS.

Got it. Olivier, [indiscernible] just the second one for me. How are you thinking about Asian outreach and how the products [indiscernible] battery of yours to find CCC, life of a battery and whatnot. How are you thinking on packaging this? [indiscernible] the same inspired, if the adds makes sense or you'll intend launching a targeted approach for bilateral stim?

So first of all, Suraj, we will further leverage or more clinical data. I think this is really important so that we look at patient phenotypes where we know we are extremely efficient, the adult patient population. Then when it comes to AHI, and I would like to point this out in DREAM, our AHI range it's 15 to 65 in which is already different compared to competition, where it's 20 to 50. So there, we're already able to [ in store ] to demonstrate a strong number, 15 to 65. So that is one aspect.

Another aspect is what we learned in market research is for physicians it's extremely important to know that their patients will be protected through at entire night. So this is something that is not only resonating well with ENT servings, 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. So 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 Genio.

And then last, when it comes to the outreach, yes, we have a focused launch. We start with 25 territory managers. They all cover 4 to 6 centers. I think already explained how concentrated the business there 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. And that, to John's point, will also become one of our key metrics in measuring our success going forward, and it gives us the ability in short term also to reach all 350 to 400 high-volume sites. Hope this is answering your question.

Our next question comes from the line of Ross Osborn with Cantor Fitzgerald.

This is Matt Park on Ross today. Congrats again on FDA approval. So starting off with Olivier on VAC approvals, how should we think about a reasonable pace for account openings through the remainder of '25 and into '26? And then are there any headwinds here that we should be mindful of?

Yes. No, it's an excellent question in the sense that what the team did really successfully start segmenting also the VAC committees by time they need in order to reach a decision. And 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. But you also have a number of VAC committees that will really take their time, and time can go up to 9 months in some advance -- and in some cases.

So 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. And 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 6 months.

Got it. That's super helpful. And then I got one for John here. As we're thinking about spend in the back half of the year and into '26, 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 I can provide some color in terms of how we're thinking about the investment levels. So for -- so 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 we're making in the IP litigation front. From an SG&A perspective, that will be obviously year-over-year, considering the investments that we made in our sales and commercial efforts in the U.S. with the 50 highly talented professionals we have in that organization.

And then 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. So we could expect to see potentially the SG&A spend nearly double in 2026 over the level seen in 2025.

Congrats again, guys.

Our next question comes from the line of David Rescott with Baird.

Great. 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-in to reimbursement there? Is that fully ironed out? Just how do we think about what the prior-auth and VAC processes are relative to kind of what line of CPT code and commercial coverage...

Sure. Yes. Thanks for the question, David. Yes. So early on, it's clearly early on in the process. But in terms of the approvals that we received, vis-a-vis the VAC and/or the pre-authorizations, the answer is yes. So 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. And 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. And as Olivier mentioned, there are various lengths of process for these VACs as well the pre-authorization process, the VAC approvals can range anywhere from very short periods of time up to 9 months. And on the pre-authorization process, it's extended as well. So that's where we're at this point in time and look forward to continuing to build this body of approvals.

Yes. And maybe in addition to this, if you allow me to add. HGNS is -- there is no longer one company that is offering an HGNS solution. I mean with Genio, we entered the market. There is now an option to choose. And that's why today -- as of today, there is an HGNS treatment solution, and there are different companies offering this. And I think that's also important.

So the previous work done in the past, it was also linked to HGNS. So all the VAC committees, they recognize this and they know what it is and what it can do. And 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. And then maybe on the CCC patient population. You've got the -- no contraindication. There's the warning that it wasn't tested, but you have ACCCESS that is coming. One, I guess, I don't know if you called out a time line, I might have missed it on the ACCCESS side for when that data should read out. But I guess 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 ACCCESS kind of fully in hand?

So when it comes to the ACCCESS trial, so now we stopped the enrollment. So the time clock for 12 months can start. So 12 months from now, we will have the data of our ACCCESS patients. And then based on the study data, we will submit a PMA supplement. Normally, this takes roughly another 6 months before FDA grant you a supplement.

So if you do the math, earliest end of Q4 '26, beginning Q1 '27, 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. And 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. So would it be fair to assume that you can start treating CCC patients since there is no contraindication? Maybe pump the gas on that once you have ACCCESS out in the PMA supplement in? Or in the near term, are you really kind of just waiting for the ACCCESS results?

So in the near-term we are waiting for the ACCCESS results, and let me be very clear on this one. We would never promote an off-label indication. And today's CCC, it's also for Genio off-label in the U.S. So we would never ever promote this. But on the other hand, it is clear that it's not a contraindication, and it is in the warning section of our labeling. So physicians, they know what this means.

Our next question comes from the line of Michael Polark with Wolfe Research.

I have two. First on pricing. Can you confirm as you launch now in the U.S., intend to price at Inspire's level of [ $25,000? ] Or has the thought process on pricing changed?

No, indeed. So we use the same CPT code, and we are following also the price strategy that it comes with the CPT code, to your point.

Okay. That's what I figured. I just thought it -- worth clarifying as we go into launch. And then 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 targeting 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?

And 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 as 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.

No. Thank you, Mike, for this question. And 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 technology, and we can unfortunately not train all of them at the same time.

So what we are asking is before a physician is eligible to join a training or invited for a training, they need to come with 5 patients, clearly defined patients, and we use the criteria as the same criteria as in the DREAM study. So we ask them to come with 5 patient cases. Then they get the training. We can already discuss those 5 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, that we ask them 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 5 cases, meaning that they will all go through their surgical learning curve, then we are convinced that they will make the right decision when patients are coming and then also patients will know if they can choose a bilateral stimulation with a single incision. All the different differentiating factors, full body MRI compatibility that we will be able to capture a lot of patients with our Genio technology.

Ladies and gentlemen, that concludes our question-and-answer session. I will now turn the call back over to Olivier Taelman for the 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 already 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. And finally, after so many months, years of hard work, I'm pleased that we can enter this, and the entire team is extremely exciting. So you will and I look forward to also updating you on our progress in the coming months. So 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.