Nyxoah SA (NYXH) 2025 Q2 法說會逐字稿

Hello. Welcome to Nyxoah's 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. 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 US 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. 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. 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 US 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 AGNS therapy for their patients. For Nyxoah, it's 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 Genio system becomes the first and only high-level AGNS therapy approved in the US 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.

All these key differentiators represented in our off-label highlights our ability to treat patients with positional OSA. This is important as according to published data, 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 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 US-specific clinical data.

Our goal is allowed to make Genio available for US 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%. The patient satisfaction was scored at 92%. This data confirms our early experience in Europe. We believe the publication of the DREAM 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 US 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 [implant systems], where they will position Genio a differentiated option for patients suffering from OSA. 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 (inaudible) 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 US.

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. We feel confident that we will be able to differentiate (inaudible) 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 payers 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 US 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 Genio implant in just our first week of commercialization. This early interest gives us confidence in the success of the US launch.

We have also identified demand from patients who are hesitant about receiving an implanted battery, which requires the need for subsequent surgery to replace this battery. The Genio system addresses this need with its unique and less invasive design.

There has recently been a lot of discussion on the potential impact of GLP-1 on the AGNS market. Contrary to our 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 AGNS patient population, this will be outweighed by a significant number who becomes eligible for AGNS.

On another topic, prior to Genio FDA approval, Inspire Medical initiated a patent lawsuit against Nyxoah. Since Nyxoah was founded, we have invested significantly in our IP portfolio. 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 lower enthusiasm in the market place.

To conclude my opening remarks, I want to emphasize that the FDA approval marks a pivotal moment for Nyxoah. Our bilateral stimulation technology offers a truly differentiated solution that makes us unique for patients. We believe Genio can fundamentally improve the quality of life for OSA patients by giving them a good night's sleep.

With the current ongoing momentum and physicians already lining up patients for Genio, we are confident in our ability to execute a successful US 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 EUR1.3 million in the second quarter of 2025 compared to EUR800,000 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 EUR19.9 million versus EUR13.3 million in the second quarter of 2024. This was driven by the acceleration in the company's commercial investments in the US, in preparation for post-FDA commercial launch.

Our cash position, including cash, cash equivalents, and financial assets, was EUR43 million at June 30, 2025, compared to EUR63 million at March 31, 2025. We also have EUR27.5 million available to us under our term debt facility, which can be drawn down in two equal tranches of EUR13.75 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 [moat] 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 US OSA market with our innovative Genio solution. The launch is actively ongoing. The enthusiastic response from physicians and the patients reinforces our confidence in the success of this US launch.

We believe the remainder of 2025 will be a transformative period as we establish Genio in the US 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 questions and answers.

(Operator Instructions)

Jon Block, Stifel.

Obviously, congratulations to you and the team.

I'll start off, just any year-end '25 metrics (inaudible) indications to focus on? Pre-physicians? I don't know, I throw that one out there. I know you said you already have -- I think it was over 100. Should we be dealing with this to that, the number of certified centers, a 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 '25 in regards to the Genio launch?

Yeah. 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-à-vis maybe number of accounts opened or pre-authorization approvals received. However, at this point in time, we're still working through that. We'll share more on our next quarterly call with all of you.

Fair enough. And then, I'll 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.

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.

Yeah. 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, that starts also by being certain that we can protect patients throughout the entire night, regardless in what sleep position they are.

That is why position in OSA is so important that also there, we can continue showing a highly-effective technology and therapy. So far, Genio is the only technology that is offering this. That comes to the supine data and the position of OSA.

When it comes to CCC, of course, there, it's extremely encouraging to see that also FDA is recognizing this by not giving us a contraindication, compared it to competition. As you know, with ACCCESS -- there, we also did great work. We had (inaudible) implanting a significant number.

So no, 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.

Both are reflected in the label. I know that you and many of your colleagues have questions on this in the past. Again, it is confirming what we were telling you that bilateral stimulation is making a difference compared to unilateral stimulation. This definitely will also help convincing physicians when they have to choose between the two available AGNS technologies.

Adam Maeder, 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 aiming to target first? Are there centers from the DREAM study, some of the high-volume implanters? Can you just give us any color around the accounts and any (inaudible) strategy there?

Yeah. No. No. Definitely. As I mentioned in the script, we have a two-pronged approach.

First of all, we go and our sales team will focus on high-volume hypoglossal neurostimulation implanting accounts. Maybe as a quick reminder to this: you know that in the US, there are roughly 1,400 implanting accounts offering AGNS. But it stays a very concentrated market; meaning, 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 started with a team of 50 commercial people; of which, 25 are territory managers. They will all have four to six of these accounts. We have built what we call a scalable technology. 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. The way we are doing this is that (inaudible), it's totally different compared to the way it's done in the past in a sense that we will focus on patients that have moderate to severe OSA and (inaudible) CPAP.

Also, there, focusing on those specific patient groups will definitely strengthen the trust and confidence of sleep physicians. We'll also further make sure that patients in need to a treatment will get a sleep surgeon that can help them with a Genio solution.

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, 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 payers. Would it be fair by the end of this year? Or is it a more of a 2026 story?

Yeah. Thanks, Kyle. I can take this question.

In terms of our reimbursement strategy, we have a comprehensive reimbursement strategy. We're using, as you may be aware, an established CPT code. At launch, we're using the 64568 code.

We've worked closely with the AAO on that particular code. We've participated in the FDA's Early Payor Feedback Program. We've also been working with engaging CMS and major commercial payers in the US around this particular code.

So as we work through this multi-faceted approach and strategy, we expect these decisions will start coming in. First, for the pre-authorization, 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.

Suraj Kalia, 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.

Olivier, a quick one. Let me start off: you mentioned ACCCESS enrollment has been stopped. I presume that the [SMB] chimed in and helped you reach that decision?

Yeah. When it comes to the ACCESS 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 forward enough to use this terminology, we have more than enough patients.

Maybe to give you some background on this -- and I'm looking also what is happening in the [OSPREY] study -- we know that the number of patients that we are having, we are already more than double the number of patients than they have in OSPREY, where they're also looking at CCC patients.

That's just as a side comment but I think important information for you to know, as well.

And then, the next thing on this, why we made this 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. Therefore, here, we cannot wait.

When you have enough patients implanted, we do think it is a well-calculated decision to stop earlier and that we can activate the 12-month follow-up timeframe. 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 handle '26 beginning late, beginning '27, also to add this to all label in the US and be able to help CCC patients that are currently contraindicated for AGNS.

Got it. Olivier, (inaudible). Just the second one for me: how are you thinking about Asian outreach and how the products of life of about (inaudible) supine (inaudible)? How are you thinking on packaging this? If you can think about (inaudible) the same inspire the odds makes sense or you'll intend launching a targeted approach for (inaudible)?

First of all, Suraj, we won't further leverage for more clinical data. I think this is really important so when that we look at patient, we look at 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 -- 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 (inaudible) to demonstrate strong number, 15 to 65. That is one aspect.

Another aspect is what we learned in market research: for physicians, it's extremely important to know that the patients will be protected throughout the entire night. This is something that is not only resonating well with ENT (inaudible) 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 the patient is in what position.

So it's a great benefit: being able to show protection towards the night for a sleep position, 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 started with 25 territory managers. They open up four to six samples -- I think already explained -- or concentrated the business still in the US. We will scale quarter after quarter by adding roughly 50 new territory managers. Each time, adding up to 75 new implant sites.

That's why, to Jon's point, we will also become one of our key metrics in measuring our success, going forward. It gives us the ability in short term also to reach all 350 to form high-volume sites.

Hope this is answering your question.

Ross Osborn, Cantor Fitzgerald.

This is Matt Park, on Ross today. Congrats on FDA approval.

Starting off with Olivier on VAC approvals, how should we think about a reasonable pace for account openings through the remainder of '25 and into '26? And then, are there any headwinds here that we should be mindful of?

Yeah. No. It's an excellent question.

Understand that what the team did really successfully was started segmenting also the VAC committees by time they need in order to reach a decision. What we learned is you have some that go extremely fast. As I already mentioned, we have the first -- and we have several of those fast-track committees where we already passed the VAC committee but you also have a number of VAC committees that will really take their time. Time can go up to nine months in some (inaudible), in some cases.

Here, we will focus and follow the segmentation. The fastest, of course, there, we'll (inaudible) immediately. That's how we further scale up.

I do not want to set expectations on saying this is the precise number that we will achieve by the end of this year. But it is clear that in our targeted approach, all the hospitals that we are targeting, they also will go through the VAC. We expect all of them to gain (inaudible) approval in the coming six 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 US, can you walk us through some of the puts-and-takes around operating leverage that we should be mindful of?

Sure. Absolutely. From an OpEx perspective, we don't provide specific guidance but maybe we can provide some color in terms of how we're thinking about the investment levels.

So for the back half of this year, in terms of OpEx spend, we'd expect to see R&D continue at a pretty consistent rate and then, maybe be a little bit up year over year, considering some of the investments 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 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&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.

David Rescott, 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. Can you just help us understand what considerations go into those VAC and prior-auth conversations? Are you definitively 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 what (inaudible) CPT code and commercial coverage (inaudible)?

Sure. Yeah. Thanks for the question, David. Yeah.

It's clearly early on in the process. But in terms of the approvals that we received vis-à-vis the VAC and/or the pre-authorization, the answer is yes. We've gone through the process. I think, really, what we're looking to do there is demonstrate the clinical efficacy and the effectiveness of the technology. Certainly, utilizing the HGNS code, the 64568 code on the CPT side.

We've been able to have success in demonstrating that, at least in this early stage, to those hospitals and accounts and centers where we've completed the VAC.

As Olivier mentioned, there are various lengths of process for these VACs, as well the pre-authorization process. The VAC approvals can range anywhere from very short periods of time up to nine months. 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.

Yeah. Maybe in addition to this, if you'll allow me to add, AGNS -- there is no longer one company that is offering an AGNS solution. With Genio, we entered the market. There is not an option to choose.

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. The previous work done in the past, it was also linked to AGNS. So all the VAC committees recognize this. They know what it is and what it can do.

As of today, there are two companies who can offer a solution. It's up to the 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 don't know if you called out a timeline, I might have missed it on the ACCCESS side. For one, that data should read out. But how do we think about the patients that are on the CCC side that can get treated today versus those that you can go after and target, once you have access fully in hand?

When it comes to the ACCCESS trial, no, we stopped the enrollment. The time clock for 12 months can start. So 12 months from now, we will have the data of all ACCCESS patients.

And then, based on this study data, we will submit the PMA supplement. Normally, this takes roughly another six months before FDA grants you a supplement. So if you do the math, the 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 (inaudible) that FDA is recognizing already that CCC is something where they would like to see US specific data before adding the level. But they also recognize the fact that CCC should not be a contraindication.

I think that's an important first step in the direction in opening it up in the US market for patients -- also, OSA patients -- suffering from CCC.

Okay. 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 access out in the PMA supplement end? Or in the near term, are you really just waiting for the ACCCESS results?

We are waiting for the ACCCESS results. 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 US.

So we would never have a promoter. But on the other hand, it is clear that it's on a contraindication. It is in the warning section of our labeling. So physicians, they know what this means.

Michael Polark, Wolfe Research.

I have two. First, on pricing. Can you confirm, as you launch now in the US, intent to price at (inaudible) level [25,000]? Or has the thought process on pricing changed?

No, indeed. We use the same CPT code. 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's 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. You'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?

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 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 implants.

Thank you, Mike, for this question. It's also a question, of course, as you can imagine, that we termly discussed as well because we have a lot of demand from physicians from (inaudible) to be trained on the Genio technology.

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 training, they need to come with five patients -- clearly defined patients. We used the criteria of the same criteria in the DREAM study.

So we asked 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.

When it comes to market share and (inaudible) [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, they will all go through their surgical (inaudible), 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.

Through all the different differentiated factors, full volume or compatibility, 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 US. 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 US.

Finally, after so many months, years of hard work, I'm pleased that we can answer this. And then, the (inaudible) is extremely exciting.

We look forward to also updating you on our progress in the coming months. Thank you, all, again. Have a nice day.

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