管理層發言
Good day, and thank you for standing by. Welcome to the Nyxoah Fourth Quarter Full Year 2025 Earnings Conference Call. Operator instructions were provided. Please be advised that today's call is being recorded. I'd now like to hand over to our first speaker today, Pearson Dennis, Investor Relations Associate. Please go ahead.
Thank you. Good afternoon, everyone, and welcome to our fourth quarter and full year 2025 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our fourth quarter 2025 financial results released after U.S. market closing today. After which we will host a question-and-answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section on the Investor Relations tab of our website. Before we begin, I'd like to remind you that any statements that relate to expectations or predictions of future events, market trends, results or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these forward-looking statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F, which will be filed with the Securities and Exchange Commission. With that, I will now turn the call over to Olivier.
Thank you, Pearson. Good day, everyone, and thank you for joining us for our fourth quarter and full year 2025 earnings call. Let me start by our '25 key milestones and highlights. '25 was a transformative year for Nyxoah. We achieved several defining milestones during the year. In early 2025, in anticipation of FDA approval, we hired and trained our U.S. commercial team, including our first 25 sales reps. We developed our strategic launch plan, worked on securing market access and mapped out target accounts focused on the top 400 highest volume hypoglossal nerve stimulation accounts around the U.S. On August 8, we received U.S. FDA approval for Genio, followed by actively launching our product. We secured reimbursement for Genio across both Medicare and commercial payers, resulting already in first implants and revenue as early as September 2025. We successfully executed on our focused launch in the United States. We trained 145 surgeons in 125 high-volume hypoglossal nerve stimulation accounts, of which 57 already received positive value analysis committee approval, resulting in $4.5 million of revenue generated in Q4. This translates into $720,000 annualized sales rep productivity during the first full quarter of launch. From a clinical data perspective, the DREAM pivotal study was published in the Journal of Clinical Sleep Medicine. These data demonstrated Genio's clinical efficacy in both supine and non-supine positions as reflected in our labeling and differentiating us from competition. Internationally, we continued driving growth in selected markets, including Germany, United Kingdom and the Middle East. We closed 2025 with a global gross revenue of EUR 11 million, driven by strong Q4 U.S. launch momentum. Now let me dig in deeper, starting with our commercial update. The fourth quarter marked our first full quarter of U.S. commercialization following FDA approval, and we are excited with the first launch results. Let me share with you the key leading indicators that we are tracking. As of December 31, 2025, with our 25 sales reps, we focused on 125 out of the 400 top HGNS accounts in the U.S. From these accounts, 145 surgeons were trained. We completed 120 value analysis committee submissions and received 57 approvals already with no VAC rejections to date. U.S. reimbursement has been consistent for Medicare and large commercial payers to date. For the past months, I've had the chance to meet multiple surgeons and fleet customers across the U.S., hearing consistent positive feedback on Genio's unique approach and the optionality we now offer to patients and physicians. Surgeons are attracted by the bilateral stimulation, the single incision procedure and the consistent therapy efficacy across all sleeping positions, which makes Genio unique on the market. In their interactions with patients, they highlight the patient-centric design, including the battery-free implantable, full-body MRI compatibility and no need for resurgery due to battery depletion or software upgrades. In addition, sleep physicians note that the first wave of activated patients in the U.S. are providing strong positive feedback on therapy outcomes. From a reimbursement perspective, ahead of FDA approval, we worked to align Genio coverage with the broad framework of hypoglossal nerve stimulation therapies across both commercial payers and Medicare. I'm pleased to report that Genio has been consistently reimbursed by both commercial payers, which represents approximately 90% of our business and Medicare, which represents the remaining 10% of the Genio business during Q4. Recently, there has been a lot of discussion and communication regarding HGNS reimbursement overall. As is typical for a relatively new product category, in combination with an expanding landscape where Genio enters the market, procedural coding practices continue to mature. In February 2026, CMS established new interim C-codes for HGNS that facilities will use when billing for traditional Medicare patients, including specific codes, 8011, 8012 and 8013, which apply to external power devices, including the Genio system. Last Friday, CMS indicated that the new C-code 8011 used for the Genio implant would be reimbursed in the hospital outpatient department at $31,526, in line with 2026 coverage for CPT code 64582. This also means that there is no reimbursement difference between the Genio system and competition. Staying with Medicare, the introduction of C codes does not change how surgeons build their physician fee for Medicare procedures. Surgeons are responsible for selecting the appropriate CPT code and potential modifier use. Given recent CMS guidance, we expect surgeons will elect to use CPT 64582 for the physician fee. Let us now turn to commercial payers, which represent approximately 90% of our business. Claims continue to be processed on the CPT Code 64582 or 64568, depending on payer policy, contractual terms, documentation and individual case review. To date, we have seen strong trial authorization outcomes across cases submitted to commercial payers, including many of the largest in the United States. In conclusion, we view the current reimbursement agreement as a normal maturation of an established therapy. With the recent clarity on the facility fee of $31,526 for the Genio C code, we are confident that it will not have any negative impact on further Genio adoption going forward. We remain actively engaged with specialty societies and coding authorities to support long-term dedicated HGNS CPT codes. From an internal update perspective, while the U.S. is the growth driver, international markets continue to provide a consistent revenue contribution. Our goal is to ensure each of our international markets are profitable with Germany being the first that has achieved this goal. In summary, entering the U.S. market in 2025, which is the largest HGNS market in the world, completes our transition to a commercial organization. The momentum we see in the U.S. launch reinforces our confidence in the opportunity ahead. With that, I will now turn the call over to John for a detailed overview of our financial results.
Thank you, Olivier. Starting with the fourth quarter, gross revenue was EUR 6.3 million before EUR 700,000 of revenue deferrals, mainly due to disposable patches, which are delivered over time, resulting in net revenue of EUR 5.6 million compared to EUR 1.3 million in the fourth quarter of 2024. This growth was driven by our U.S. commercial launch, which resulted in approximately EUR 3.5 million of net revenue in the fourth quarter of 2025. Gross margin was 64% in the fourth quarter. Total operating loss for the fourth quarter of '25 was EUR 18.6 million compared to EUR 18.3 million in the fourth quarter of 2024. Notably, operating loss remained relatively stable year-over-year despite significant commercial investments made to support our U.S. commercial launch. Now let's turn to the full year 2025 results. Gross revenue was EUR 11 million before EUR 1 million of revenue deferrals mainly due to disposable patches, resulting in net revenue of EUR 10 million compared to EUR 4.5 million in 2024 or 122% year-over-year growth. Gross margin for the full year of '25 was 63%. Total operating loss for the full year 2025 was EUR 83.5 million compared to EUR 58.8 million in 2024. The increase in total loss reflects the acceleration of U.S. commercialization activities in preparation for commercial launch. Our cash position as of December 31, 2025, which includes cash, cash equivalents and financial assets, totaled EUR 48 million. Now as we turn to revenue guidance, we expect U.S. net revenue for both the first and second quarters of 2026 to grow 25% sequentially. This sequential growth in the U.S. reflects continued surgeon training, additional value analysis committee approvals and growing surgeon adoption. International revenue is expected to follow typical seasonal patterns. With that, I'll now turn the call back to Olivier for closing remarks.
Thank you, John. For 2026, our priority is clear: continue executing on our U.S. commercial launch. To that end, we increased already our sales force by 15 sales reps and 3 sales directors in the first quarter of 2026, bringing us to a total of 40 sales reps, covering 200 of the top 400 hypoglossal nerve stimulation accounts. During 2026, from a clinical perspective, we are looking forward to see our 12-month ACCCESS study data on complete concentric collapse and subsequent PMA supplement submission, potentially leading to a U.S. label expansion in early 2027. As a fast-growing company, we are expanding our internal manufacturing footprint to further strengthen our competitive position and improve our gross margins. We expect our 2026 execution to translate into a very strong financial profile as we gain market share in the U.S. Thank you for listening, and your continued interest and support for Nyxoah. With that, I would now like to open the lines for questions and answers.
分析師問答
Our first question comes from the line of Adam Maeder from Piper Sandler.
Congrats on the progress. Two questions for me. The first one is just on some of the leading indicators or metrics that you shared Olivier. If I heard correctly, you have 120 VAC submissions that were made as of December 31 last year, and I think 57 accounts activated. Can you just kind of help bridge us for the remaining 60 or 63 VAC processes and kind of where those stand? When should we expect more accounts to go active? And just talk about the funnel for new accounts as we move towards that 400 hypoglossal stimulation account target? And then I have a follow-up.
Thank you, Adam. So to your point, we have submitted 120 VAC submissions, and already 57 are approved. The other ones will be approved, and we already saw the first ones being approved in Q1. As you know, not every hospital has the same timeline when it comes to VAC approvals, but we were extremely pleased to see already the first 57 during Q4. So you can expect the remaining to start being approved during Q1. That answers the first part of your question. The second one is regarding the sales force and how many accounts we are covering and how many new accounts we will open going forward. As I mentioned during my remarks as well, we already increased our hiring by 15 additional sales reps. So we went from 25 to 40. And with that, on average, each of those 15 will add 5 new accounts, so that can add up to 75 additional accounts, resulting in 200 out of the 400 high-volume accounts that we will be covering during Q1 and Q2. I hope this answers your question.
Very helpful, Olivier. For the follow-up, I guess I'm going to ask about complete concentric collapse and the ACCCESS study. If I heard correctly, I think you're targeting early approval in 2027. Maybe just help us understand when we're actually going to see that data presented. I assume that's this year. And if you could put a finer point on submission timing. I think that's a PMA supplement, but wanted to confirm that.
Yes. So yes, it is a PMA supplement that we will be submitting. Now coming back on timing, we had to wait for 12-month data. So by the end of June, we will have 12-month data of all patients. Then we will go into the analysis of the clinical data that will take up to 30 days. So by the end of July, we should have a good view on how the data look and also use this to prepare our PMA supplement submission. There, we are constrained by the regulatory timeline that we cannot really change or influence. So that's why we calculate more or less one quarter, about 90 days, once we have submitted our data, and that's how we end up entering Q1 2027 to obtain the approval. As for publishing the data, we will do this as soon as we have our data, so somewhere in July, and then depending on journal acceptance we will publish and present them during one of the congresses that we will target.
Our next question will come from the line of Jon Block from Stifel.
John, maybe I can just start with you. Obviously helpful on some of the guidance figures. But any more color you can give us around the cash burn rate either for the quarter, 1Q even on an annual basis when we start thinking about 2026? And then I'll just ask a follow-up.
Sure, Jon. Thanks for the question. In terms of cash burn, we're looking at approximately EUR 20 million cash burn per quarter in the near term. Recall in the fourth quarter, we raised capital via a PIPE as well as convertible debt, which provided us additional cash to get into the first quarter of 2027. So with the capital we have on the balance sheet, and the cash burn of approximately EUR 20 million in the near term, which will decrease as we gain revenue traction in the U.S., that will provide us capital into the first quarter of 2027.
Okay. Got it. Very helpful. And then let me pivot. Olivier, maybe for you, I could throw a couple of questions your way. The first one is, I think your competitor has been pretty transparent about pursuing their own code and maybe going down that road for Jan 1 of 2028. I think the C codes bridge you for a little while, but your thoughts on pursuing your own code, what that will entail and what that may mean. And then can you give us an implant number, the number of implants that were done maybe as of the end of the year or any color that you're willing to give us into 2026, because clearly, of those 57 accounts activated you should be. I mean you're selling into the shelf a little bit when we start thinking about the revenue number.
Yes. Thank you, Jon. So when it comes to reimbursement coding, I'm pleased that we see progress and clarity on the facility fee, and that we fully understand what the use of the interim C codes means and how it's impacting business going forward. On pursuing our own coding, we are following the same pathway forward as competition is doing as well. I do think, listening carefully and interacting with AMA and other stakeholders, that there will be dedicated coding in place, most likely around the beginning of 2028. In the meantime, the facility fee is clear. We are now waiting for clarity on the physician fee, although physicians and experts tell us they don't expect many differences from the previous CPT 64582 coding for the physician fee. Regarding the number of implants: we decided in our leading indicators not to communicate the precise number of implants. On the other hand, it is relatively straightforward to estimate when you know we generated $4.5 million of revenue in the U.S. in Q4 and you know the average price for the system is about $25,000. That's an easy way to estimate. But in our KPIs, we do not provide precise implant numbers. I hope this answers your question, Jon.
Yes. Okay. I mean I get the math of the ASP and the revenue, and I can do that. But again, some are sitting on the shelf, right? So you were previously giving implants. I guess I'm trying to just get more granular on how many implants were done, not how many units were sold, of which a subset is sitting on the shelf. But I could follow up with you offline.
No, I don't want to avoid this. So first of all, it's clear that we have no policy of putting products on the shelf. We also clearly don't do any consignment. I want to point out there is no consignment. The way our sales force operates in the field: when we train surgeons, they come with pre-identified patients. Once they have these patients, most of the time they are coming with three to five patients. Based on this, we provide them with that number of implants, and we provide one, maximum two extra implants depending on whether it's three or five cases, so there is some backup in case something goes wrong. I hope this clarifies: we are not loading shelves. We are implanting patients.
Our next question will come from the line of Suraj Kalia from Oppenheimer.
Olivier, can you hear me all right?
Yes, perfect.
Perfect. Olivier, congrats on all the progress. I just wanted to follow up on the previous question to get my bearings right. Your competitor's approach has been to have a minimum of four to five units upfront when a new site is added on, and larger sites can have 10 or 12 implants on the shelves. So Olivier, when you say a new site comes online with three identified patients, is your approach also really about four to five unit upfront sales? Is that the right way to think about it? And by the same token, as high-volume centers come online, do you think this dynamic of each player holding inventory on the shelf is sustainable? I know it's a long question; hopefully you've got the gist.
No, I'll start by answering the first part. As I said, we treat patients, and we do not want to load shelves. I keep insisting on this. With the example you used, when we have three patients lined up for implants, we sell four, maximum five devices depending on what the surgeon prefers as a potential backup. So that is what we are doing. We are not selling additional devices that then sit on the shelf. Second, regarding other competitors: I read their announcements and I want to congratulate them, but it also means they are not actively launching currently and may be targeting a launch in early 2027. We expect clear differentiation across technologies: Genio with bilateral stimulation, an external variable component and a single incision versus pacemaker platforms that will be more alike to each other. I feel confident in our differentiated Genio approach, and I believe patients and physicians will make choices based on those differences.
Fair enough. And one follow-up, Olivier. The 57 or so sites that you have trained — admittedly, it is early — but what are you seeing as the key drivers for Genio in these sites? What is the key reason that physicians are asking to have this on the shelves? There has been chatter about bearded patients and device preference, so just give us an idea about what you're seeing in the field to set the stage for market share approximations between the players.
Thank you, Suraj. First, let me clarify: we have trained surgeons active in 120 of the 125 targeted high-volume accounts. The 57 number refers to accounts where we already have a full VAC approval and where we were actively doing business during Q4. Regarding why surgeons choose Genio, three major buckets summarize the feedback. First, optionality: Genio breaks the previous monopoly and offers an alternative for patients and physicians who may not prefer a pacemaker. Second, surgical differentiation: the single incision implant technique resonates well with surgeons compared to multiple incisions. Third, therapy differentiation: bilateral stimulation provides a quality of airway opening with an effective tongue movement solution. These three items — optionality, single-incision approach, and bilateral stimulation — are the consistent drivers we hear from surgeons.
Our next question will come from the line of David Rescott from Baird.
This is Tommy Han on for Dave. I was wondering if you guys would like to put a finer point on your assumptions and guidance around new account adds versus increasing utilization in your existing accounts relative to the Q4 exit rate?
As I mentioned earlier, we have a focused approach. With the 25 salespeople starting immediately post-FDA approval, we were able to reach 125 out of the 400 high-volume accounts. Today, with the added 15 reps we are reaching 200 out of the 400 accounts. We have already trained 145 surgeons. There is a waiting list for surgeon training. We conduct training sessions almost every weekend across the U.S., and we will significantly increase the number of accounts where we can do business and implant patients, potentially up to 200 accounts. VAC submissions vary by account — sometimes as fast as two weeks, sometimes a month, sometimes longer. Gradually scaling up, by the end of Q1 you should expect us to be present in up to 200 accounts.
Great. And I was wondering if you guys wanted to provide a little bit more color around OpEx guidance and gross margin guidance for 2026, and what the drivers are behind that? Separately, for procedures performed so far, can you help us understand where those patients are coming from? Are they patients who were expecting to get another HGNS device or more people who have been waiting on the sidelines?
I'll take the last part of the question on where patients are coming from. In those high-volume accounts there are well-established referral networks, and we see patients being referred the moment they are evaluated by the surgeon. With Genio, there is optionality; patients are proposed both technologies, and we see a high number choosing Genio for the reasons I mentioned: minimal invasive surgery, designed so patients can forget they even have an implant, upgradable software, an intuitive patient app and no need for resurgery. These attributes appeal to patients. We are also establishing strong relationships with sleep physicians and driving referrals for Genio patients.
Thanks, Tommy. On the model: in regards to gross margin, I would expect gross margin to increase slightly over the balance of the year, due to increased sales volume and being able to spread overhead over more units. So you'll see a slight increase in 2026 as we move through the year. The major step function increase in gross margin that you can expect is probably in early 2027 when we launch our next-generation disposable patch activation chip — Genio 2.2 specifically — which will enhance the patient experience and allow us to significantly reduce the cost of the disposable patch. That next step function could move gross margin into the low 70% range in 2027. In terms of OpEx, we don't provide specific OpEx numbers for guidance, but color-wise: R&D expense, which includes quality, regulatory, medical affairs, clinical in addition to true R&D, should decline sequentially in 2026 as some investments made in 2025 to prepare for commercialization fall off. SG&A's main driver is U.S. sales expansion. As Olivier mentioned, we expanded by 15 sales reps and three sales directors in Q1 2026, so you'll see the run rate increase due to that expansion. All other infrastructure investments will be leveraged as we build out the commercial organization.
I'm not showing any further questions at this time. With that, this concludes the question-and-answer session. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.