Nyxoah Q2 2025 Earnings Report

Nyxoah EPS Results

• Actual EPS: -$0.63
• Consensus EPS: -$0.62
• Beat/Miss: Missed by -$0.01
• One Year Ago EPS: N/A

Nyxoah Revenue Results

• Actual Revenue: $1.58 million
• Expected Revenue: $1.33 million
• Beat/Miss: Beat by +$246.00 thousand
• YoY Revenue Growth: N/A

Nyxoah Announcement Details

• Quarter: Q2 2025
• Date: 8/18/2025
• Time: After Market Closes
• Conference Call Date: Monday, August 18, 2025
• Conference Call Time: 4:30PM ET

Nyxoah (NASDAQ:NYXH) S.A., a medical technology company, focuses on the development and commercialization of solutions to treat sleep disordered breathing conditions. The company's lead solution comprises Genio system, a CE-Marked, patient-centric, and hypoglossal neurostimulation therapy to treat moderate to severe obstructive sleep apnea. Nyxoah S.A. was incorporated in 2009 and is headquartered in Mont-Saint-Guibert, Belgium.

Nyxoah Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: The company secured FDA PMA approval for its GENIO system, making it the first bilateral AGNS therapy approved in the US and authorizing immediate commercial distribution.
• Positive Sentiment: The approved label highlights no contraindication for complete concentric collapse and includes positional OSA, underscoring the clinical advantages of bilateral stimulation over competitors.
• Positive Sentiment: US launch has begun with a 50-member commercial team targeting 350–400 high-volume HTNS centers, achieving early VAC and pre-authorization wins and training over 100 physicians.
• Neutral Sentiment: Q2 revenue rose 73.8% to €1.3 M with a 63.4% gross margin, but operating loss widened to €19.9 M and cash declined to €43 M due to ramped launch investments.
• Negative Sentiment: Inspire Medical’s patent lawsuit introduces legal risk, though management expects no immediate impact on the ongoing US commercialization.

Presentation

[Operator]

Hello, and welcome to Nexeo's Second Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you would need to press star one, 1 on your telephone. You would then hear an automated message advising your hand is raised.

[Operator]

To withdraw your question, I would now like to turn the conference over to Pearson Dennis. You may begin.

[Pearson Dennis, Investor Relations Associate at Nyxoah]

Thank you. Good afternoon, everyone, and I welcome you to our second quarter twenty twenty five earnings call. Participating from the company today will be Olivier Talman, Chief Executive Officer and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our second quarter twenty twenty five financial results released after U. S.

[Pearson Dennis, Investor Relations Associate at Nyxoah]

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.

[Pearson Dennis, Investor Relations Associate at Nyxoah]

These forward looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward looking statements. All forward looking statements are based upon current available information and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these forward looking statements. For a list and description of our risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20 F filed with the Securities and Exchange Commission on 03/20/2025. With that, I will now turn the call over to Olivier.

[Olivier Taelman, CEO & Director at Nyxoah]

Thank you, Pearson. Good day everyone and thank you for joining us for our second quarter twenty twenty five earnings call. I'm extremely proud to announce that we received FDA PMA approval for our GENIOR system in The United States. This result was the culmination of persistent strong regulatory and clinical execution supported by the entire passionate and committed Myxoa team. For US patients suffering from obstructive sleep apnea or OSA, the GENIOR system provides them with a significant advance from currently available treatment options.

[Olivier Taelman, CEO & Director at Nyxoah]

For physicians, they now have a choice to select the optimal AGNS therapy for their patients. For Nexoa, it marks the beginning of an exciting journey in The US. This PMA approval confirms the safety and effectiveness of our innovative technology and authorized commercial distribution in The US which now has actively begun. The GENEOX system becomes the first and only bilateral AGNS therapy approved in The US for treatment of OSA. It's also important to note that the GENEO system is not contraindicated for patients suffering from complete concentric collapse or CCC.

[Olivier Taelman, CEO & Director at Nyxoah]

Another key differentiator representing 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. Adding 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 sleep position. Also note that complete concentric collapse of CCC is not contraindicated but is included as a warning in the company's label as the safety and effectiveness for patients suffering from CCC has not yet been established for the GENIOR system based on US specific clinical data. Our goal is however to make GENEU available for US patients suffering from CCC as soon as possible.

[Olivier Taelman, CEO & Director at Nyxoah]

Therefore, we strategically elected to stop enrollment in the ACCESS study. We believe that the number of patients enrolled in ACCESS will have enough statistical power to draw meaningful conclusions on our effectiveness for complete concentric collapsed patients. In addition, we see great results in real life 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 demonstrate a high level of patient satisfaction.

[Olivier Taelman, CEO & Director at Nyxoah]

The device demonstrated compliance of eighty five point nine percent and the patient satisfaction was scored at ninety percent. This data confirms our early experience in Europe and we believe the publication of the DREAMM study will strengthen our US 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.

[Olivier Taelman, CEO & Director at Nyxoah]

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 three physicians managing large populations of moderate to severe OSA patients who quit CPAP but are in need for treatment. Our US 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.

[Olivier Taelman, CEO & Director at Nyxoah]

S. Regarding reimbursement, we have identified the use of CPT code 64568, which has been recognized by commercial and government payers for the OSA indication. This is the same CPT code used by our competitors and we feel confident that we will be able to differentiate ourselves via our unique technology benefits and patient focus. As a result of our ongoing work with the American Academy of Otolaryngology and participation in the FDA's early payer feedback program educating CMS and major commercial payers on the clinical impact JINIO 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 US already trained and additionally weekly training sessions scheduled, there is strong momentum building in the medical community. Organization traction in the marketplace is demonstrated by the many physicians lining up patients for a genuine implant in just our first week of commercialization.

[Olivier Taelman, CEO & Director at Nyxoah]

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 Geneox system addresses this need with its unique and less invasive design.

[Olivier Taelman, CEO & Director at Nyxoah]

There has recently been a lot of discussion on the potential impact of GLP-one on the AGNS market. Contrary to our competitors, we have strategically limited our patient population to those with a BMI below thirty two, 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 third month study data showing GLP-one's ability to bring patients with high BMIs of thirty seven and above down to a BMI level where clinical data demonstrate that Gnu is effective. Without GLP-1s, we would never be able to treat this high BMI patient population.

[Olivier Taelman, CEO & Director at Nyxoah]

While there might be patients with lower BMIs dropping out of the potential AGNS patient population, this will be auto weighted by significant number who becomes eligible for AGNS. On another topic, prior to Genio FDA approval, Inspire Medical initiated a patent lawsuit against Nixoa. Since Nixoa 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 US 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 Nixora.

[Olivier Taelman, CEO & Director at Nyxoah]

Our bilateral stimulation technology offers a truly differentiated solution that makes us unique for patients. We believe Jineo can fundamentally improve the quality of life for OSA patients by giving them a good night's sleep. With the current ongoing momentum and physicians already lining up patients for Jineo, we are confident in our ability to execute a successful US launch. With that, I'll turn the call over to our CFO, Jean Laundry for a financial update.

[John Landry, CFO at Nyxoah]

Thank you, Olivier. We recorded revenue of €1,300,000 in the 2025 compared to €800,000 in the 2024 for an increase of 73.8. Gross margin in the 2025 was 63.4% or essentially flat to the 2024. Total operating loss for the 2025 was $19,900,000 versus $13,300,000 in the 2024.

[John Landry, CFO at Nyxoah]

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 €43,000,000 at 06/30/2025 compared to €63,000,000 at 03/31/2025. We also have €27,500,000 available to us under our term debt facility, which can be drawn down in two equal tranches of €13,750,000 each which are subject to certain milestones.

[John Landry, CFO at Nyxoah]

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.

[Olivier Taelman, CEO & Director at Nyxoah]

Before we conclude, I want to emphasize that this FDA approval represents a truly historic moment for Nixova. I would like to thank all Nixova employees for their persistence and effort in making this happen. We have now officially entered The US OSA market with our innovative Genius 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.

[Olivier Taelman, CEO & Director at Nyxoah]

Launch. We believe the remainder of 2025 will be a transformative period as we establish GENEO 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 earning calls.

[Olivier Taelman, CEO & Director at Nyxoah]

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

[Operator]

Thank you. Ladies and gentlemen, as a reminder to ask a question, please press 11 on your telephone and then wait for your name to be announced. Our first question comes from the line of Jon Block with Stifel. Your line is open.

[Jonathan Block, Managing Director at Stifel Financial Corp]

Thank you. Hey, guys. Good afternoon. I don't know, Jon, obviously, a big congratulations to you and the team. I'll start off just any year end 2025 metrics, any indicators to focus on trained physicians, I don't know, I'll throw that one out there, even though I know you said you already have, I think it was over 100.

[Jonathan Block, Managing Director at Stifel Financial Corp]

Should we be getting a glimpse to that, the number of certified centers, the number of implants? I know it's early days, but just as we think about over the next three or four months, where our eyes or where our focus should be as we think about exiting 2025 in regards to the GENEO launch? Thank you.

[John Landry, CFO at Nyxoah]

Yes. Thanks for the question, John. In terms of some of the leading indicators that we're tracking, obviously we mentioned today the number of physicians trained. That's going to be something that we keep a close eye on, as that's obviously a leading indicator. We'll also be looking at the number of value analysis committee applications that we submit to the various institutions over time, as that's also another leading indicator.

[John Landry, CFO at Nyxoah]

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.

[Jonathan Block, Managing Director at Stifel Financial Corp]

Fair enough. Thanks for that. And then I'll sort of pivot. Olivia, 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 triple C contraindication, the sleep positional data.

[Jonathan Block, Managing Director at Stifel Financial Corp]

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.

[Olivier Taelman, CEO & Director at Nyxoah]

Thank you, John for this question as well. Yes, clearly it was for us a bit important win to also see this differentiation reflected in the label. As our mission is always make sleep simple and that starts also by being certain that we can protect patients throughout the entire night regardless in what sleep position they are. And that is why positional OSA is so important that also there we can continue showing an highly effective technology and therapy and so forth. Gnu is the only technology that is offering this.

[Olivier Taelman, CEO & Director at Nyxoah]

So that comes to the supine data and the positional OSA. When it comes to CCC, of course there 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 access so there we also did great work we had our PIs implanting a significant number so now we can closely and 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 US. So both are reflected in the label. I know that you and many of your colleagues had 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 NGS technologies.

[Jonathan Block, Managing Director at Stifel Financial Corp]

All right, great color. Thanks. Hang up more, but I'll hop back in the queue for now. Thanks guys.

[Olivier Taelman, CEO & Director at Nyxoah]

Thank you, John.

[Operator]

Please stand by for our next question. Our next question comes from the line of Adam Mayer with Piper Sandler. Your line is open.

[Kyle Winborne, Equity Research at Piper Sandler Companies]

This is Kyle on for Adam. Thanks for taking the questions and we extend our congrats on FDA approval as well. Maybe just first to double click a little bit on the commercial strategy that you discussed in prepared remarks. I'm 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?

[Kyle Winborne, Equity Research at Piper Sandler Companies]

Can you just give us kind of any color around the accounts and the strategy there? Thanks.

[Olivier Taelman, CEO & Director at Nyxoah]

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 hypoglossum neurostimulation implanting accounts. Maybe as a quick reminder to this you know that in The US there are roughly fourteen hundred in planning accounts offering AGNS, but it stays a very concentrated market, meaning that three fifty 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.

[Olivier Taelman, CEO & Director at Nyxoah]

We start with a team of 50 commercial people of which 25 of territory managers. They will all have four to six 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 so that we can cover as soon as possible all 400 of those high volume implanting accounts. So that is what we called you know focused launch. Next and I think as important is also strengthening the referral parts and the way we are doing this in that technique so 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 are quitting CPAP and also there focusing on those specific patient groups will definitely strengthen the trust and confidence of sleep physicians and will also further make sure that patients in need for treatment will get a sleep surgeon that can help them with the Genius solution.

[Olivier Taelman, CEO & Director at Nyxoah]

So that's all we plan to go forward with our launch strategy.

[Kyle Winborne, Equity Research at Piper Sandler Companies]

That's super helpful. Thanks for the color there. 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 any logistical considerations around like the work that you're doing with the different payers? And then maybe more specifically, when can we expect to see some onboarding of some of the larger payers? Would it be fair by the end of this year? Or is it kind of more of a 2026 story? Thanks again, guys.

[John Landry, CFO at Nyxoah]

Yeah, 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.

[John Landry, CFO at Nyxoah]

We've worked closely with the AAO on that particular code. We've participated in the FDA's early payer feedback program. And we're also been working with engaging CMS and major commercial payers in The US 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.

[John Landry, CFO at Nyxoah]

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.

[Kyle Winborne, Equity Research at Piper Sandler Companies]

Perfect. Thank you.

[Olivier Taelman, CEO & Director at Nyxoah]

You're welcome.

[Operator]

Please stand by for our next question. Our next question comes from the line of Suraj Kalia with Oppenheimer. Your line is open.

[Suraj Kalia, MD & Senior Analyst at Oppenheimer & Co. Inc.]

Hey, Olivia. John, can you hear me all right?

[Olivier Taelman, CEO & Director at Nyxoah]

Yes, we can. Hello, Suraj. Perfect.

[Suraj Kalia, MD & Senior Analyst at Oppenheimer & Co. Inc.]

Gentlemen, congrats on the approval. I know it's been a long time coming and on the label. So Olivier, quick one. Let me start out. You mentioned access enrollment has been stopped.

[Suraj Kalia, MD & Senior Analyst at Oppenheimer & Co. Inc.]

I presume that the SME chimed in and helped you all reach that decision.

[Olivier Taelman, CEO & Director at Nyxoah]

Yeah, so when it comes to the access study, in fact we reach a significant number of patients that are already implanted that gives us the confidence that if we have to draw statistically conclusions that are statistically forward enough to use this terminology that we have more than enough patients. Maybe to give you some background to Raj on this and I'm looking also what is happening in the OSFIRE 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 OSFIRE 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 make the decision is we want to help patients with CCC in The US 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 twelve month follow-up time frame.

[Olivier Taelman, CEO & Director at Nyxoah]

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 '26 beginning latest 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 AGNS.

[Suraj Kalia, MD & Senior Analyst at Oppenheimer & Co. Inc.]

Got it. Olivier, I'll question, so just a second one for me. Olivier, how are you thinking about patient outreach and packages of products specific attributes, supine, CCC, lack of a battery, whatnot, are you thinking about packaging this? Do you think making that even as distinct, inspired to see ads make sense? Or you're intending on taking a targeted approach for bilateral stent? So

[Olivier Taelman, CEO & Director at Nyxoah]

first of all Suraj we will further leverage on our clinical data. I think this is really important so that we look at patient phenotypes where we know we are extremely efficient. You know the adult patient population then when it comes to AHI and I would like to point this out in dream of AHI range it's 15 to 65 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.

[Olivier Taelman, CEO & Director at Nyxoah]

Another aspect is what we learned in market research is that for physicians is extremely important to know that their patients will be protected through OGN iodide. So this is something that it's not only resonating well with ENT surgeons but it's very well resonating with sleep physicians who have to refer patients because they see this effect when they start studying polysomnography sleep exams they see exactly when a patient is in what position 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 a genio and then last when it comes to the outreach yes, we have a focused launch. We start with 25 territory managers. They will cover four to six centers. I think I already explained how concentrated the business still is in The US 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 really 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 three fifty to 400 high volume sites. Hope this is answering your question.

[Suraj Kalia, MD & Senior Analyst at Oppenheimer & Co. Inc.]

Thank

[Operator]

you. Our next question comes from the line of Ross Osborne with Cantor Fitzgerald. Your line is open.

[Matthew Park, Equity Research Associate at Cantor Fitzgerald]

Hey, guys. This is Matt Park on for Ross today. Thanks for taking the questions and congrats again on FDA approval. So starting off with Olivier on back approvals, how should we think about a reasonable pace for account openings through the remainder of 2025 and into 2026? And then are there any headwinds here that we should be mindful of?

[Olivier Taelman, CEO & Director at Nyxoah]

Yeah, no, it's an excellent question. In the sense that what the team did really successfully is to augmenting 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 time we have several of those fast VAC committees where we already passed the vet committee, but you also have a number of that committee that will really take this time and time can go up to nine months in some advantage and so in some cases. So here we will focus and follow the segmentation.

[Olivier Taelman, CEO & Director at Nyxoah]

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 facts and we expect all of them to gain us an approval in the coming six months.

[Matthew Park, Equity Research Associate at Cantor Fitzgerald]

Got it. That's super helpful. And then that one for John here. As we're thinking about spend in the back half of the year and into 2026 as you guys build out your commercial infrastructure in The U. S, can you kind of walk us through some of the puts and takes around operating leverage that we should be mindful of?

[John Landry, CFO at Nyxoah]

Sure, absolutely. From an OpEx perspective, we don't provide specific guidance, but maybe we can provide some color in terms of how we're thinking about the investment levels. So for so the back half of this year, in terms of OpEx spend, we'd expect to see R and D continue at 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 and A perspective, will be up obviously year over year considering the investments that we made in our sales and commercial efforts in The US 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 and 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.

[John Landry, CFO at Nyxoah]

So, we could expect to see potentially the SG and A spend nearly double in 2026 over the levels seen in 2025.

[Matthew Park, Equity Research Associate at Cantor Fitzgerald]

Got it. Thanks for the color. Congrats again, guys.

[Olivier Taelman, CEO & Director at Nyxoah]

Thank you.

[Operator]

Please stand by for our next question. Our next question comes from the line of David Rescot with Baird. Your line is open.

[David Rescott, Senior Research Analyst at Baird]

Great. Thanks for taking the questions and congrats on the approval here. I wanted to ask first on reimbursement, the VAC, the prior auth processes that you've called out in the prepared remarks. I guess, you just help us understand what considerations go into those VAC and prior auth conversations? Are you definitively kind of locked into reimbursement there?

[David Rescott, Senior Research Analyst at Baird]

Is that fully ironed out? Just how do we think about what the prior auth and VAC processes are relative to kind of what the underlying CPT code and commercial coverage

[John Landry, CFO at Nyxoah]

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 receive vis a vis the VAC and or the pre authorizations, the answer is yes. So, 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.

[John Landry, CFO at Nyxoah]

Certainly utilizing the HTNS code, the 6400568 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 as the pre authorization process. The VAC approvals can range anywhere from very short periods of time up to nine 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

[Olivier Taelman, CEO & Director at Nyxoah]

build this body of approvals. Yeah and maybe in addition to this if you allow me to add. AGNS no there is no longer one company that is offering an AGNS solution. I mean with Genio we enter the market, there is no an option to choose and that's why today as of today there is an AGNS treatment solution and there are different companies offering this. I think that's also important.

[Olivier Taelman, CEO & Director at Nyxoah]

So the previous work done in the past it was also linked to Ag and S so all the faculties 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 solution and it's up to their physicians that will decide together with the patient what solution they will choose.

[David Rescott, Senior Research Analyst at Baird]

Okay, great. And then maybe on the DCC patient population, you've got the no contraindication, there's the warning that it wasn't tested, but you have access that is coming one. I guess I don't know if you called out a timeline, I might have missed it on the access side for when that data should read out. 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 access kind of fully in hand?

[Olivier Taelman, CEO & Director at Nyxoah]

So when it comes to the access trial, so now we stop the enrollment. So the time clock for twelve months can start. So twelve months from now, we will have the data of all access patients and then based on this study data, we will submit a PMA supplement. Normally, this takes roughly another six months before FDA grant you a supplement. So, you do the math, earliest '26 beginning Q1 twenty seven, we could have CCC patients added to the label.

[Olivier Taelman, CEO & Director at Nyxoah]

Today, with having no contraindications, we are very proud that FDA is recognizing already that CCC it's something where they would like to see US 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 US market for patients, also OSA patients suffering from CCC.

[David Rescott, Senior Research Analyst at Baird]

Okay, so would it be fair to assume that you can start treating CCC patients since there is no contraindication maybe a pump the gas on that once you have access out and the PMA supplement in or in the near term, you really kind of just waiting for the access results? Thank you.

[Olivier Taelman, CEO & Director at Nyxoah]

So in the near, so we are waiting for the access 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 a genie 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.

[David Rescott, Senior Research Analyst at Baird]

Okay, perfect. Thank you.

[Operator]

Thank you. Please standby for our next question. Our next question comes from the line of Michael Pollock with Wolfe Research. Your line is open.

[Mike Polark, Senior Equity Research Analyst - Medical Devices at Wolfe Research, LLC]

Hey, good afternoon. I have two. First one, pricing. Can you confirm as you launch now in The U. S, intent to price at Inspire's level $25,000 Or has the thought process on pricing changed?

[Olivier Taelman, CEO & Director at Nyxoah]

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.

[Mike Polark, Senior Equity Research Analyst - Medical Devices at Wolfe Research, LLC]

Okay. That's what I figured. Just thought it worth clarifying as we go into launch. And then my second question is, if you look to open accounts, is there an ask you're making of these surgeons? You know, you invest in them.

[Mike Polark, Senior Equity Research Analyst - Medical Devices at Wolfe Research, LLC]

You train them. You're gonna be, you know, targeting and competing for patients on their behalf. That's an investment that you make. What what kind of return do you ask of these initial centers, if anything? And I'm just thinking, like, look.

[Mike Polark, Senior Equity Research Analyst - Medical Devices at Wolfe Research, LLC]

They're they're all in the business of hypoglossal nerve stim. They have large wallets. What what is a share of wallet, that you're 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 Is it 10%, 20%, is it more? I'd love a feel for how you go about those initial conversations and signing up this initial group of implanters. Thank you.

[Olivier Taelman, CEO & Director at Nyxoah]

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 for HMO to be trained on the GNIO 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 the training or invited for the training they need to come with five patients clearly defined patients and we use the criteria as the same criteria in the dream study. So we ask them to come with five patient cases, then they get the training. We can already discuss those five patients so they can be implanted right after they go back after being trained. That's what we do.

[Olivier Taelman, CEO & Director at Nyxoah]

When it comes to market share because you are really also the last 10 or 20% market share, honestly we don't at this stage. We do think that if they are well trained, high quality training, they do their five cases meaning that they will all go through their surgical learning curve, then we are convinced that they will make the right decision when patients are coming and that also patients will know if they can choose a bilateral stimulation with a single incision you know all the different differentiating factors full body MRI compatibility that we will be able to capture a lot of patients with our genealogy.

[Mike Polark, Senior Equity Research Analyst - Medical Devices at Wolfe Research, LLC]

Thank you for the color.

[Operator]

Thank you. Ladies and gentlemen, that concludes our question and answer session. I will now turn the call back over to Olivier Taubman for closing remarks.

[Olivier Taelman, CEO & Director at Nyxoah]

Thank you again for your time today and your continued support of Nixoa. As I mentioned in the beginning, this is the most exciting time in our company history. We so excited to be able to launch in The U. S. I will also not forget our international markets where we're also making good progress, but it's clear that the market is in The U.

[Olivier Taelman, CEO & Director at Nyxoah]

S. And finally after so many months, years of orthotic, I'm pleased that we can answer this and then the advice team is extremely exciting. You will and I will look forward also updating you on our progress in the coming months. So thank you all again and have a nice day.

[Operator]

Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.

Participants

Executives

• Pearson Dennis, Investor Relations Associate
• Olivier Taelman, CEO & Director
• John Landry, CFO

Analysts

• Jonathan Block, Managing Director at Stifel Financial Corp
• Kyle Winborne, Equity Research at Piper Sandler Companies
• Suraj Kalia, MD & Senior Analyst at Oppenheimer & Co. Inc.
• Matthew Park, Equity Research Associate at Cantor Fitzgerald
• David Rescott, Senior Research Analyst at Baird
• Mike Polark, Senior Equity Research Analyst - Medical Devices at Wolfe Research, LLC