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Date

Thursday, November 13, 2025 at 4:30 p.m. ET

Call participants

  • Chief Executive Officer — Olivier Taelman
  • Chief Financial Officer — John Landry

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Takeaways

  • Revenue -- €2 million for the quarter, representing a 56% increase.
  • Gross margin -- 60.5%, compared to 62% in the same period last year.
  • Operating loss -- €24.4 million, compared to €15 million for the comparable period, attributed to higher US commercial investment.
  • Cash position -- €22.5 million as of September 30, 2025, compared to €43 million at June 30, 2025.
  • Q3 US revenue -- €231,000 reported from the first commercial Genio implants.
  • US implants -- 15 Genio devices implanted across nine accounts within the initial four weeks of launch.
  • Surgeons trained -- 111 surgeons trained within the initial 125 targeted US high-volume sites.
  • Value Analysis Committee (VAC) submissions -- 102 submissions completed, with 35 approvals secured.
  • Reimbursement approvals -- 21 approvals from 63 prior authorization submissions, with a 100% success rate; Medicare and ten private payers, including UnitedHealthcare and Cigna, now cover Genio.
  • Average selling price -- CFO Landry said, "right in the ZIP code of 25,000 from an average selling price for our implants."
  • US commercial focus -- The company targets the top 125 of 400 high-volume AGNS implant sites, representing 75%-80% of total market volume.
  • 2025 full-year revenue guidance -- CFO Landry stated, "we expect global revenue to be between €3.4 million and €3.6 million."
  • New financing -- Up to $77 million in capital secured, including a $25 million private equity placement and a $52 million convertible bond, providing cash runway into 2027.
  • Surgeon and patient feedback -- CEO Taelman said physicians identify bilateral stimulation as a "unique and differentiated" feature and highlight lack of required battery replacement surgery.
  • Near-term gross margin outlook -- CFO Landry indicated gross margin improvements are not expected until late 2026 or 2027, tied to Genio 2.2 rollout, production scaling, and supply chain optimization.

Summary

Nyxoah (NYXH 9.85%) began US commercialization of Genio following FDA approval on August 8, reporting implantation in 15 patients during the first four weeks and measurable early revenue generation. Management secured widespread reimbursement by achieving VAC approvals in more than a quarter of targeted accounts, obtaining Medicare and ten private payer contracts, and facilitating rapid prior authorization cycles using CPT code 64568. The newly announced $77 million capital raise strengthens Nyxoah's balance sheet and extends runway beyond projected US market expansion milestones. International momentum persists in Europe and the Middle East, where Genio holds exclusive AGNS status in some regions. The next generation Genio platform aims to introduce AI-driven personalization and operational improvements expected to impact margins and clinical differentiation after 2026.

  • US launch efforts included the deployment of 25 territory managers focused on early activation of the most significant AGNS implant centers.
  • Clinical response cited strong demand from both male and female patients averaging 52-54 years old and highlighted elective "implant for life" attributes as important decision drivers.
  • The majority of site approvals required a stepwise process—training, VAC submission, and payer preauthorization—leading to roughly four-week timelines from preauthorization submission to revenue.
  • For coding and reimbursement, CPT code 64568 was accepted by Medicare and the major insurers Nyxoah has worked with for Genio therapies.
  • Future gross margin improvements depend on US procedure scaling and hardware/software enhancements planned for Genio 2.2, not expected to materially impact results until late 2026 or beyond.

Industry glossary

  • AGNS (Anterior Geniohyoid Nerve Stimulation): A targeted neurostimulation therapy for treating obstructive sleep apnea via bilateral hypoglossal nerve stimulation.
  • VAC (Value Analysis Committee): A hospital-based committee responsible for product evaluation and procurement approvals, including new implantable medical technologies.
  • CPT code 64568: The Current Procedural Terminology code currently recognized in the US for hypoglossal nerve stimulation procedures, required for billing and reimbursement.
  • Genio Access Program: Nyxoah's dedicated support service for guiding customers through prior authorization, payer communication, and reimbursement tracking for Genio implants.

Full Conference Call Transcript

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 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, 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 03/20/2025. With that, I will now turn the call over to Olivier.

Olivier Taelman: 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 US 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 beyond of a single solution market. During the recent International Surgical Free Society, ICFFF meeting, our Genio Symposium 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 both differentiated bilateral patient-centric design resonates strongly with both surgeons and treating 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 US, completed as early as September, represented an important milestone for our teams and partners, already generating $231,000 in revenue during the third quarter and ahead of our expectations.

Subsequent feedback has emphasized streamlined patient management, close collaboration between ENTs and treating physicians, and solid patient follow-up engagement. While still early, this reinforces our confidence that Genio is well-positioned to serve US OSA patients with a compelling new alternative. We are navigating the critical steps of early commercialization, and the momentum we are generating in training physicians, obtaining value analysis committee approvals, and securing coverage for major public and private payers has been extremely encouraging. In our initial launch strategy, with 25 territory managers, we are focused on the initial 125 of the top 400 high-volume implant sites representing roughly 75 to 80% of the total AGNS volume.

We are actively tracking a number of leading indicators to measure our early progress. Since launch, until October, we can report that out of the 125 targeted accounts, 111 surgeons have already successfully been trained. On the 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, and 21 approvals have been already received, with a 100% success ratio. In all of these approvals, the CPT code 64568 was accepted. 15 implants were already successfully performed across nine accounts in the first four weeks.

Beginning on the road since the launch and interacting with surgeons, I've been incredibly encouraged by the feedback I'm getting. Surgeons are enthusiastic to finally have a second AGNS option to offer treatment over safe. 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 tone protrusion achieved with bilateral stimulation. They report that the Genio procedure is efficient, with procedure times up to sixty 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 towards customers for prior authorizations. Each territory manager works with a dedicated case manager who interfaces between the clinical team, patient, and sales team. The program includes a reimbursement helpline and communication portal for real-time tracking. To date, we have achieved 100% approval on all prior authorization submissions through our Genio access program, including with private payers such as UnitedHealthcare, Blue Cross Blue Shield, Healthcare 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. Healthcare Service Corporation, or HCSC, operates Blue Cross Blue Shield plans in Illinois, Texas, Oklahoma, New Mexico, and Montana.

HCSC and Blue Cross Blue Shield of Michigan have updated 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 six states. We continue engaging with additional commercial payers and expect continued progress on coverage decisions in the coming quarters. Looking ahead, our priorities are clear. We will continue expanding our US 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 US, we are focused on driving deeper penetration in Germany and in the United Kingdom, where we maintain a strong presence, and in the Middle East, where we hold exclusive status as the only available AGNS solution, while selectively expanding into additional geographies with strong demand for a differentiated technology. This is an exciting time for Nyxoah S.A. 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 the financial review.

John Landry: Thank you, Olivier. We recorded revenue of €2 million in the third quarter of 2025 compared to €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 €24.4 million, versus €15 million in the third 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 €22.5 million at 09/30/2025, compared to €43 million at 06/30/2025.

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 US. This financing includes a private placement of equity approximately $25 million, which included existing strategic investors Cochlear and ResMed, as well as our chairman and management team members. It also includes a convertible bond which can provide us with up to $52 million in two tranches, with the first tranche of $26 million available upon closing of the convertible note. The second equally sized tranche can be drawn down at the company's discretion for the thirty days starting seven months after the closing of the transaction.

We believe the proceeds of this transaction, in conjunction with currently available capital, provide us with cash runway into 2027. For 2025, we expect global revenue to be between €3.4 million and €3.6 million. With that, I'll now turn it back over to Olivier for some closing remarks.

Olivier Taelman: Thanks, John. As we close, I want to remind everyone what truly defines Nyxoah S.A. The future of sleep medicine will be defined by those companies who understand and continuously learn from their patients. With Genio, we are not treating sleep apnea as a one-time event. We are managing a chronic condition. Our system learns from every breath every night, turning data into insights and insights into better outcomes. We will be integrating the power of AI and self-learning in our next generation of Genio, developing a therapy that adapts, evolves, and becomes more personalized over time. It's not just about features of a device.

It's about creating an ecosystem that involves patients, physicians, and healthcare payers to manage sleep apnea smarter, simpler, and more sustainably. At Nyxoah S.A., everything we do starts and ends with the patient, and we will continue to evolve with 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 to good sleep quality. And at Nyxoah S.A., 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: Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press 11 on your telephone. If your question has been answered, you may remove yourself from the queue by pressing star 11 again. Our first question comes from Ross Osborn with Cantor Fitzgerald. Your line is open.

Ross Osborn: Hey, guys. Congrats on the progress. Excited to see the US launch going well right off the bat, and thanks for taking our questions. So maybe starting off, more on the qualitative side, can you provide some feedback that you're hearing from docs as well as their patients on why they're choosing Genio versus other options?

Olivier Taelman: Yeah. No. 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. The second thing that we are hearing as well that is always coming out is the fact that we offer a bilateral stimulation solution that is really respecting the anatomy of the upper airway and mouth. That is also resulting in an option to treat patients also with more complex airway obstructions. So those are the two main things that keep coming back that we're hearing first.

Ross Osborn: Okay. Great. And then, last and apologies if I missed this, where do you stand on your Salesforce build-out?

Olivier Taelman: So as I was already communicating, we do a focused launch on the top 400 implant accounts in the US, so the high-volume AGNS sites. With our current Salesforce, we are covering the first 125 out of this 400. We will further scale by adding every quarter up to 15 territory managers that will represent them over 75 implant sites. So if you do a little bit of calculation behind, after four quarters, we would be able to cover all of these 400 high-volume implant sites. Speed a little bit further, and we would end up with a sales force of 85 people.

Ross Osborn: Great. Thanks for taking the questions, and congrats on the progress.

Olivier Taelman: Thank you.

Operator: One moment for our next question. Our next question comes from Adam Maeder with Piper Sandler. Your line is open.

Adam Maeder: Hi, good afternoon. Thank you for taking the questions and congrats on the US 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 US in Q3. Can you just give us that number again as well as the US revenue in Q3?

Olivier Taelman: Yes. Definitely. So we did 15 implants spread over nine different accounts, and they were all done in the month of September. And we did €231,000. Okay. Yeah. Just to be clear on that, 15 was through October. Oh, sorry about that. This 15 is through October. And the $231,000 was through September for euro-denominated revenue.

Adam Maeder: I got it. Okay. That's helpful. And then I guess just kind of a related question. But as we think about models for Q4 and US launch, appreciate, John, you gave us, you know, €3.4 million to €3.6 million outlook for the overall business. Any finer point you want to put on US versus OUS at this point?

John Landry: Yeah. I appreciate the question, Adam. You know, at this point, we're not gonna break out the US versus international in terms of guidance. We're still in the early phases here of the account activation ramp in the US. And that Q4 guidance really reflects the continued acceleration of US implants. As more accounts complete VAC approvals and prior authorizations, more surgeons are trained, we also see sustained growth in both Germany and the UK.

Adam Maeder: Okay. Understood. And just one last one, if I may. Olivier, if I heard correctly, did you say the device is gonna become potentially more proximal over time, did I catch that remark correctly? And if so, you know, maybe just walk us through the appeal of going proximal versus distal. Thanks.

Olivier Taelman: Adam, I think you must have misheard this because I never talked about proximal versus going more distal when it comes to the use of our mobile device, so I want to be very specific on this. We have our specific positioning where we place the electrodes on the hypoglossal nerve. And that is also very well adapted if I can refer to this or if 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 course, where we keep putting the patient at the center and then we are talking about integrating self-learning into our device becoming smarter and more adaptive. So that patients also can get more control about their own technology.

Adam Maeder: Okay. Thanks for clarifying, Olivier. Apologies about that.

Olivier Taelman: Thank you. No problem. No problem, Adam.

Operator: One moment for our next question. Our next question comes from Suraj Kalia with Oppenheimer. Your line is open.

Suraj Kalia: Hi. Would that be a Jonathan? Have you alright?

Olivier Taelman: Yes. Thank you. Hi. Nice evening, Suraj.

Suraj Kalia: Perfect. Hey, Olivier. I'll ask both of my questions together, and pardon the background noise. I'm in an airport. So maybe of the coverage implant, admittedly, they're very, you know, relatively a smaller quantity. Right? Can you give us an idea of where the initial appeal is? Is it bilateral? Is it CCC? Is the lack of IPG packet? Is it supine, non-supine? You know, bit okay. This is an issue for the 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, you know, sites, that you're, like, targeting, I appreciate you walking us through in terms of physical codes and whatnot. You that are getting through. Would it be how is Genio being slotted from a logistical perspective? Because most sites of these high-volume sites have these quote-unquote inspired days. Right? And, obviously, the push is on to ramp up Inspire five and you know, put more. And is Genio slotted on Inspire days, or are y'all seeing the separate? At least from a logistical perspective? Gentlemen, thank you for taking my questions, and congrats on the progress done.

Olivier Taelman: I will try to have this completed and canceled. I've got it was quite a long question until your point, and the sound quality wasn't as good as I would hope it to be. Alright. So first of all, I do want to emphasize how Genio is totally differentiated from a place-based mixed platform technology. And this is also determining the choice of physician. So I think the first part of the question was why Genio? And then 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 viable to treat one or the other. It's clear that it applies and appeals very well with both male and female. What you'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. Understand that they do value the power of not needing re-surgery when a battery is depleted, not needing re-surgery benefit from the latest integrated software upgrade.

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 unlabeled because that's we are waiting for the excess study data outcome. Where we closed enrollment, and what we expect to show next year around this period, because we need to do a twelve-month follow-up.

So CCC is not contraindicated, it's under the warning. And it can be chosen for a physician. At physician discretion it's not unlabeled. So I wanna be very clear on this. And then last, when we also talk about Genio and compare 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 were making the monopoly that is currently there by giving options of choice. And we were also hearing through market research and value encouraging songs that physicians are seeing this as becoming a market where it will end up.

In a fifty-fifty or even with some main payloads in our favor. A lot of enthusiasm, the clear differentiation of that space negative, a clear differentiation in patients choosing the implant for life, approach, with no need for re-surgery going forward no differentiation between male, female, it's at this moment based on the numbers and the experience we build in the US. We see that both are really high. Benefiting and then choosing for the Genio. I hope that answers your question. There's therapy. Thank you.

Operator: One moment for our next question. Our next question comes from Jon Block with Stifel. Your line is open.

Jon Block: John, maybe the first one for you. You know, just to level set, like, as we build out and refine our models, are these the KPIs that you're gonna 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, VAC, figures, is that the expectation that these will be the metrics and transparency with it every three months or so?

John Landry: For the short term, Jon, yeah. I think, you know, over the short term, you know, maybe the near term, midterm, we'll provide these metrics as we become a more material revenue generator we'll probably likely, you know, 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 want to give you give everybody a sense as to the progress we're making based on these KPIs. Then as we become a revenue generator, we'll evaluate these going forward.

Jon Block: Okay. That's helpful. And the second one is sort of a two-parter. Maybe the first one because we were sort of flip-flopping between September and October. So September €231,000 implies, I don't know, ten to eleven US implants in the month of September. And then is it number of implants total 15 through October? Do I have that correct?

John Landry: Yes. 15 implants were done through October. Correct?

Jon Block: Okay. So maybe you just wanna talk about, you know, why the number of implants were to get cut in half from September. 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 US launch for quite some time now. What was the biggest surprise in your view, you know, from the US launch over the past couple of months? Thanks for your time.

Olivier Taelman: Yep. No. And thank you, Jon, for the questions. And I think I can handle part one and part two because they are a little bit linked to each other. When you say what was the biggest surprise, I not 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 a VAC approval, we got to have a preauthorization submission followed by a preauthorization approval by a 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 is related to this, so if you see and then 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 two weeks to obtain an approval. Once you have an approval, it takes almost two weeks before you generate revenue. So in total, we are talking about roughly four weeks.

So if we then start looking when we did the submissions, because they are depending on the VAC approvals, that is also the failing 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 you already have nine centers the active implants took place in seven weeks post-approval. I did is a very encouraging result, and I wanna applaud my team for this.

Operator: Thank you. One moment for our next question. Our final question comes from David Rescott with Baird. Your line is open.

David Rescott: Great. Thanks for taking the questions here, and congrats on the launch. I wanted to follow-up on a couple points you made relative to the Q4 guide. First, on pricing, I believe the math, again, based on the 10 to 12 in or so in the quarter versus the reported US number? Puts you at that at 20 to $25 ASP. So just wanted to confirm that on a US dollar basis was, correct. And when we think about this number for Q4, again, we can see, you know, what's been done in October, and so that puts, you know, a bigger number in the, you know, November, December time frame.

So you know, how do we think about that kind of November, December cadence to hit what this implied guide is for Q4, assuming that this step up is more based on the US number?

John Landry: Yeah. Sure, David. Thank you. Thanks for the question. So from an average selling price perspective, you know, right in the ZIP code of, you know, 25,000 from an average selling price for our implants. You know, there's not exactly one for one correlation with the revenue that's booked. We have this we yeah. 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 the portion that we spread out over time. So there's, you know, that delta.

And then in terms of the, you know, the guide, we don't necessarily we're not breaking out US versus international here for the fourth quarter to get to 3.4 to 3.6%. 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 US revenue to grow from October to November and then from November again to December.

So that's how we're thinking about it and the visibility into the number of cases that we expect in here in the remaining days of the quarter here.

David Rescott: Okay. That's helpful. You know, 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, you know, into the fourth quarter, you know, into 2026. How we should be thinking about this contribution from the US rollout maybe impacting the gross margin line as you scale up and, more broadly, roll out? Thank you.

John Landry: 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 shift perspective as well as a disposal patch perspective. It also significantly reduced the cost. So that's more of a tail end in '26 early twenty-seven, but that'll 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, you know, volume breakpoints in our contract manufacturing business.

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 pro goods throughout the entire supply chain channel, that'll help be the final leg of the stool to get us up to that, you know, 80 plus percent gross margin range. So in the near term, I. E, you know, 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.

David Rescott: Okay. Perfect. Thank you.

John Landry: Welcome.

Operator: And, pardon, this is Kevin, the operator. We did have some recently queued up. Did you wanna go ahead and take that question?

Olivier Taelman: Yes.

Operator: Okay. One moment. Our next question comes from Paige Chamberlain with Wolfe Research. Your line is open.

Paige Chamberlain: Hi, guys. Good afternoon. Thank you for taking the question. And squeezing me in. I just have a couple on reimbursement. I appreciate the updates and the prepared remarks there. I guess ahead, I'm just wondering if you can help us frame, you know, how to think about the phasing of unlocking wider spread reimbursement in the US and, you know, how that progress should flow into our build of the US commercial ramp. And second question, I'll lump it in here on a similar note, obviously, have been some changes in moving parts around coding in the HGNS space. Six four five six eight is the code you guys are using now.

I'm wondering if that is, you know, still the code that is intended to be used in the long term. Thanks so much.

Olivier Taelman: Thank you. Thank you. And also refreshing the 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 AGNS therapy, being Genio or being alternative therapy. And it's providing a clear pathway for reimbursement with both Medicare and also commercial payers. So in going forward, we do think this will be the coding 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 is the code that fits best also our technology. And we're also seeing this is the coding also where the latest innovation is used for AGNS. So my thought, 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 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.

John Landry: Yeah. And they really like to point out and recognize our market access team that's doing a tremendous amount of work. And doing a great job with our Genio access program to help work through this initial process. And I think the HTSC and Cross Blue Shield of Michigan where we have six four five six eight. Is a reference procedure code. I think, you know, 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 two business week cycle time. From the time of submission to approvals. And then on the back end, once the implants are done, we'll see another two-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.

Olivier Taelman: And maybe to close on this one, well, if you see and look at the future, we'll go forward. So sometimes it's nice to be second because there was a lot of work done already, and I think AGNS is already extremely well recognized today. So we do not need to do the work on heavy lifting with every single PACE semester. Because are familiar with HNS. What it can be. The treatment of more than just to be able to say.

Operator: Thank you. I'm not showing any further questions at this time. I'd like to turn the call back to Olivier for any further remarks.

Olivier Taelman: 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 will be waiting and working hard to get to FDA approval. We obtained it and our focus is launching continue launching, opening more sites, treating more patients, this is in fact, why we were in this business and what we wanna do, offer this solution. To seriously impact patient's life. So thank you, and good afternoon, good evening, everyone.

Operator: Ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.