管理層發言
Good day. And thank you for standing by. Welcome to the Nyxoah First Quarter 26 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker today, Pearson Dennis. Please go ahead.
Thank you. Good afternoon, everyone. And I welcome you to our first quarter 26 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer, and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our first quarter 26 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 would like to remind you that any statements that relate to expectations or predictions of future events, market trends, results, or performance are forward-looking statements. All forward-looking statements are based upon current estimates and various assumptions. These forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon currently available information and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these forward-looking statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our Form 20-F filed with the Securities and Exchange Commission on March 26, 2026. With that, I will now turn the call over to Olivier.
Thank you, Pearson. Good day, everyone, and thank you for joining us for the first quarter 26 earnings call. Let me start with the Q1 26 overview. 2026 marks our second full quarter of U.S. commercialization, and we are encouraged by the strong execution of our U.S. launch. Specifically, we delivered on our commitment to drive 25% sequential U.S. revenue growth in 2026 versus 2025. In the U.S., we are seeing consistent momentum across our key commercial indicators, including surgeon training, account activation, patient prior authorization submissions, and procedure volumes. Internationally, our revenue in 2026 was consistent with 2025, which represents strong performance as we were able to grow the business and avoid the typical sequential quarter decline from the fourth quarter to the first quarter. On a worldwide basis, I am pleased to report that we grew our revenue by 13% sequentially from the fourth quarter of 2025. Let's now dig into the U.S. commercial update. The U.S. launch remains the primary driver of our worldwide revenue growth and a key priority. During the quarter, we continued to execute on our focused commercial launch strategy and further expanded our U.S. commercial field presence with an extra 15 sales reps who are now fully operational, enabling us to cover up to 200 high-volume hypoglossal neurostimulation accounts entering Q2. I am pleased to report on our U.S. launch key performance indicators as of March 31, 2026. We trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained on the Genio system. We activated a total of 34 new accounts in Q1, for a total of 91 active accounts out of over 125 targeted accounts. Active accounts are defined as surgeons trained and VAC committee approved. We have 241 new patients submitted under prior authorization and still pending at the end of Q1. We trained 15 new sales reps, bringing our total to 40 fully operational sales reps as we enter Q2. Six months post-launch, in the accounts where we are already active, we estimate our market share to be between 12% to 14% on average. With the addition of 15 new sales representatives in the U.S. who are fully trained in Q1, we will be able to cover 200 out of the 400 high-volume HGNS accounts beginning in Q2. We also recently conducted a market research study of over 100 U.S. hypoglossal neurostimulation implanters. We learned that 88% of ENTs believe it is important to have multiple hypoglossal neurostimulation options for their patients. All Genio-trained surgeons plan to adopt Genio in their practice. The top-cited reasons for adopting Genio were bilateral stimulation, no implanted battery, and offering an alternative option. Sleep medicine is the single biggest source of their patient referrals, and 84% of surgeons collaborate with sleep medicine colleagues to manage HGNS patients. The results of this market research confirm that our focused launch strategy on high-volume implantation centers, in combination with building sleep physician partnerships, will drive further Genio adoption. Let me now cover one of the hot topics of Q1: the hypoglossal neurostimulation reimbursement landscape. In order to provide you with a structured update, I would like to split it up between commercial payers, Medicare, and the WISER program. Starting with commercial payers: they represented approximately 90% of our cases in Q1. Coverage is broad and stable. Genio claims continue to be processed under existing CPT codes depending on payer policy and individual case review. For example, UnitedHealthcare recently added an additional CPT code back to their existing HGNS policy, so both codes are available for HGNS. UnitedHealthcare represents one of several commercial payers which have multiple CPT codes listed as available codes for HGNS procedures including Genio. Through the end of the first quarter, we maintained a 100% approval rate on the reviewed prior authorization submissions. Now moving into the Medicare side, which only represents approximately 10% of our cases in Q1. The year started with coding uncertainty, negatively impacting HGNS implants. On February 26, however, CMS provided clarity by issuing HGNS-specific C-codes for facilities. Claims for Genio implantation are submitted under the C-code C9.79xxx. This code represents a facility fee mapped to APC level 6 at approximately $35,100 in the hospital outpatient setting and $31,200 in the ASC setting. This is equivalent to the existing CPT code facility settings and slightly higher than the CPT code in the ASC setting. This results in price parity at facility level for Genio and competition. Next, from a physician fee perspective, claims continue to be submitted under the applicable CPT code at approximately $732. When it comes to the use of modifiers, let me reiterate that it is a physician decision based on the specific surgeon work performed and that Nyxoah is not advising to use a modifier. As to the newly established WISER program, an AI-supported prior authorization tool rolled out by CMS in six states since January 1, 2026, we have achieved a 100% approval rate of our submitted Medicare patients. The fact that reimbursement did not hinder our Q1 launch momentum is the result of the expertise of our market access team, collaborations with experts in that field, participation in the FDA early payer feedback program, and the proactive education of all our customers. Because of these factors, we expect continuity for 2026 and 2027. As part of the ongoing CPT editorial panel discussion regarding the future of HGNS coding, the panel has indicated that there is no intention to leave any HGNS technology orphaned without appropriate coding. For 2028, we understand that there are currently two paths to support continued coding: dedicated CPT codes for the different HGNS technologies, or creating a comprehensive HGNS coding set following the model laid out in the CMS C-codes. We learned that a competitor has chosen to seek its own dedicated code, which we are prepared for as well. Alternatively, specialty societies may seek to engage in a broader exercise to provide further clarity regarding coding in the HGNS space, creating a comprehensive HGNS code set. We will take our lead from the specialty societies, including AAO-HNS, since their actions are driven by the physicians performing these procedures. Let me now move to an international update. Internationally, we are seeing continued growth and we managed to overcome seasonality versus Q4 25. This was driven by strong performance in Germany, where we are going deeper in existing accounts, continued therapy adoption in the Middle East, and successful entries in the U.K. and the Netherlands. However, we maintained a disciplined financial approach focused on reaching breakeven, as demonstrated in Germany three years post-launch. With that, I will now turn the call over to John for a detailed overview of our financial results.
Thank you, Olivier. For the first quarter of 2026, gross revenue was €6.7 million before €300 thousand in deferrals due to the delivery of disposable patches which are delivered over time, resulting in net revenue of approximately €6.4 million. This represents 13% sequential worldwide growth compared to Q4 2025. U.S. net revenue was €4.3 million, representing approximately 25% sequential growth compared to €3.4 million in Q4 2025. Our U.S. revenue growth reflects continued expansion in account activation, increasing procedure volumes, and growing surgeon adoption. Gross margin in Q1 2026 was 57% as compared to 62% in Q1 2025. The decrease in gross margin was due to production yield issues in the quarter, which have been addressed. Operating expenses were €24.2 million in Q1 2026 as compared to €21.4 million in Q1 2025. The increase in operating expenses was driven by increased investment in the U.S. commercial organization, including sales, marketing, and market access functions. Non-GAAP cash operating expenses were €21.7 million in Q1 2026 as compared to €19.5 million in Q1 2025. The increase in non-GAAP cash operating expenses also reflects increased investments in the U.S. commercial organization. As of March 31, 2026, cash and cash equivalents and financial assets totaled €25.9 million. In 2026, we expect to draw approximately €13.8 million from the second tranche of our European Investment Bank loan. Now let's turn to guidance. We expect U.S. net revenue for Q2 2026 to grow approximately 25% to 30% sequentially over Q1 2026. For the full year 2026, we expect worldwide net revenue in the range of €36 million to €40 million. We expect gross margin in the range of 60% to 62%. We expect total operating expenses in the range of €97 million to €99 million. We expect total non-GAAP cash operating expenses in the range of €88 million to €90 million. Please note that our total non-GAAP cash operating expenses for full year 2026 reflect a 5% to 8% sequential increase over non-GAAP cash operating expenses of €83.5 million for fiscal year 2025. Strategically, we will focus our investments in supporting our U.S. commercial activities including sales, marketing and market access, as well as key R&D initiatives, including our 2.2 upgrade which includes a new sleep wearable with upgraded software and a low-cost disposable patch to be launched in early 2027. We decreased our total non-GAAP cash operating expenses by €300 thousand from Q4 2025 to Q1 2026. We also decreased our non-GAAP cash R&D expenses by €2.9 million sequentially from Q4 2025 and reallocated that capital into our U.S. commercialization efforts. We are applying the same principle for the G&A portion of our SG&A operating expenses, which, if we were to break them out separately, you would be able to see the transition from G&A related expenses to U.S. commercial activities. Long term, we expect to drive gross margins over 80%, and we will continue to manage our non-GAAP cash operating expenses tightly while investing in growth and gross margin improvement drivers. We believe this disciplined approach will allow us to achieve revenue breakeven below €150 million in revenue. With that, I would now like to turn the call back over to Olivier.
Thank you, John. As we enter Q2, our priorities remain clear: further execute the current launch momentum in the U.S., capture greater market share in our targeted high-volume accounts, and maintain a disciplined financial approach to OpEx and cash management. Before closing, I would like to thank the Nyxoah employees for their contribution in making Q1 a successful quarter. With that, I would like to open the line for Q&A.
分析師問答
You will then hear the automated message advising your hand is raised. We also ask that you please wait for your name and company to be announced before proceeding with your question. Our first question today will be coming from the line of Adam Maeder of Piper Sandler. Please go ahead.
Hi. Good afternoon, Olivier and John, and thank you for taking the questions. Congrats on the solid progress. Two for me. The first one is on the guidance front. I wanted to ask about the full year 2026 revenue guidance that you provided, and that is above where the Street is currently sitting. If you look at kind of where you have guided Q2 U.S. revenues, it does imply a bit of a step up in the back half of the year. I know Q4 is typically a seasonally stronger quarter, but maybe just talk about the confidence in achieving the full year outlook, especially in light of the ongoing reimbursement situation, and talk about some of the key drivers of the ramp and any help on quarterly phasing would be appreciated.
Thank you, Adam. So let me start by answering the question. First of all, as we already communicated, we continued adding salespeople into the field. So we added 15 new sales reps, bringing our total to 40 salespeople, which enable us to cover 200 out of the 400 high-volume accounts. As you also know, surgeons, when they start implanting, they go through a surgical learning curve. This takes roughly two to three implants, and then you also see that they scale up. What we learned in Q4 and Q1 is that we received a lot of positive feedback from surgeons after their first cases. On top of that, after seeing the first patient activations, what was confirmed by the strong airway openings they saw during surgery gave them even more confidence and they started treating immediately more new patients. So that is one aspect: you have more feet on the street, and you also have more experienced surgeons. In parallel, VAC approvals vary in timeline. Sometimes it ranges from one to two weeks up to a couple of months. Here, we are seeing great progress made, and we have now 91 active accounts already out of the 125 targeted sites with our initial 25 sales reps. So this is driving an acceleration in adoption and, of course, ultimately, there is also the patient referral part coming from sleep physicians. I am extremely pleased to announce that we have 241 real patients with submitted prior authorization files to commercial payers in our testing and pending queue. If you add those leading indicators up, that gives us confidence in Q2 and beyond of showing continued strong double-digit growth, even further accelerating in the second half of the year.
Adam, I'll add some numbers to this as well to answer your question. In terms of where we are and what we are looking for in productivity, we expect in the back half of the year to see our revenue growth accelerate given the fact that our new training class will be productive in the second quarter and then will ramp up over the rest of the year. So the sequential growth rates I mentioned—25% to 30% for Q2—we would expect that to accelerate in Q3 to probably about the low 40s to 45% range, and then into the mid-50% range in Q4, which, as you know, is a seasonally stronger quarter, especially in the U.S. as people have fully exhausted their deductibles. When you run that math, that is what helps provide some of the back-end growth that you will see in the model to achieve that U.S. revenue target.
And maybe, Adam, last on this one: let's also not forget that reimbursement now is fully clear and supported from both CMS with the C-codes and from commercial payers. So reimbursement is definitely not a hindering factor, as we experienced already in Q1.
Fantastic. That is a lot of very helpful color. I appreciate all that. For the follow-up, I wanted to switch over to reimbursement—everyone's favorite topic. Olivier, I guess the question is really around the longer-term strategy for Genio and how you are thinking about a permanent CPT code. I know in your prepared remarks you mentioned the AMA CPT panel meeting earlier this month. We did see the proposed meeting agenda, and there was a hypoglossal nerve code on that agenda, but from our vantage point that actually seemed to describe the competitor device versus Genio. Would you agree or disagree with that assessment? And then any help that you can give us in terms of the pathway forward to a more permanent reimbursement coding solution and timelines for Genio would be appreciated. Thank you.
Yeah. Thanks, Adam. I do think that for 2026 everything is very clear now: CMS has the C-codes, we know the WISER program where we have a strong prior authorization approval rate, and on commercial payers we are covered under the applicable CPT codes. So 2026 is crystal clear and de-risked from a reimbursement perspective. We were participating during the CPT editorial panel discussion and actively listening and participating in the discussion focused on 2027 and 2028. For 2027, we expect no change on the Medicare side—the C-code framework and physician payment are in place and operational. On the commercial side for 2027, based on the discussion, we do think that some CPT usage may be revised and migrate to a more specific AGNS code, separating some prior generalized codes. For 2028, we see two roads forward: one is dedicated CPT codes for the different HGNS technologies; the other is a more comprehensive HGNS coding set that follows the C-code model. We did see a competitor submit an application for a dedicated new CPT code, which is correct and part of the agenda. For 2028, whether the field moves to dedicated codes or to a comprehensive code set, we will be prepared. We intentionally did not yet submit a dedicated CPT request for Genio during the panel, but we are prepared to submit one going forward. We will also take our lead from specialty societies, including AAO-HNS, since their actions are driven by the physicians performing these procedures. In conclusion: 2026 is de-risked reimbursement-wise; 2027 should remain stable; and for 2028 we will follow the evolution—prepared either for dedicated codes or for a comprehensive coding set led by specialty societies.
Perfect. That is very helpful. Thank you.
Thank you. One moment for the next question. Our next question will be coming from the line of Jonathan Block of Stifel. Please go ahead.
Olivier, the first one is the 241 patients submitted under prior authorization at the end of Q1 2026—can you remind us what that number was at the end of 2025, sort of apples to apples? And then how long does it take to get those patients through the approval process, which I believe you said is still sitting at around a 100% approval rate from your vantage point?
Yes. As we left Q4, we had approximately 100 patients in the prior authorization queue. Regarding timing, commercial payers have up to 30 days to come back with an approval. As a reminder, so far we have a 100% prior authorization approval rate. Then it depends from site to site because we are talking about high-volume sites in scheduling implant times. Getting surgical time planned varies because the surgeon may be balancing multiple procedures beyond HGNS. So we see that this varies between one to two months before those patients are getting implanted.
Okay. Thank you. That is helpful color. And then maybe just to pivot to John: pro forma for the European second tranche, I think you have about €40 million, call it, of cash—roughly €26 million plus the €13.8 million. Maybe if you could remind us what the breakeven point for the company is, your views on cash burn going forward? And then just to tack on the gross margin: it continues to perplex me. When I look at the P&L, when you guys had €4 million in 2023, your gross margin was 62%, and here we are approaching €40 million in 2026 and it cannot get out of its own way in this low-60% range. What is preventing gross margins from improving as the company improves the top line? How do we think about the inflection that you anticipate in subsequent years? Thank you.
Sure. Thanks for the questions, Jonathan. Let me start with gross margin. We did have some issues with production yields in the quarter due to turnover and training issues, which have now been resolved. We expect to see our gross margins increase going forward beginning in Q2 and for the rest of the year. As I mentioned on the last call, our 2.2 new disposable patch and activation chip will be a major step-function improvement in our gross margin profile; that will be coming online in early 2027 and should provide significant uplift from the low 60s to north of 70% at that point in time, with an improved patient experience plus a significantly reduced cost profile. The next step up in gross margin improvement will be driven by cost reduction on the implant as we hit volume-based pricing milestones with our contract manufacturers. We have a high degree of confidence we will get to 80%-plus in our gross margin profile on the backs of those two initiatives. In terms of cash burn, we are very focused on managing our cash burn. We held our cash operating expenses and actually slightly decreased them from Q4 2025 to Q1 2026, despite adding 15 sales reps in the U.S. We have been focused on investing in U.S. commercialization while extending our cash runway as long as possible and not sacrificing gross margin-improvement initiatives. As we think about cash operating expenses going forward, we mentioned a 5% to 8% sequential increase this year. We would expect somewhat similar increases going forward, although we are not providing detailed long-term guidance. Long term, we expect to drive gross margins over 80% and manage non-GAAP cash operating expenses tightly while investing in growth and margin improvements. We believe achieving revenue breakeven at approximately €150 million in revenue, with an 80% gross margin and disciplined OpEx management, would require total cash in the range of approximately €100 million to get there. That is how we are thinking about it and how we plan to manage our P&L levers.
Great. Thanks for the color, guys. Thank you.
Thank you. One moment for the next question. Our next question is coming from the line of Suraj Kalia of Oppenheimer. Please go ahead.
Hi, Olivier, John — can you hear me alright?
We can hear you well, Suraj.
Congrats on a strong start to the year. Olivier, I want to follow up on John's question earlier regarding Q2 guidance: U.S. guidance is plus 25% to 30%. With 241 patients in the queue as of the end of Q1, obviously you will add more patients as Q2 progresses. If we assume 100% approval, just the patients at the end of Q1 would imply about €6 million in U.S. revenues, and that is a 50% sequential jump. Maybe you could thread the needle for us as to what your core assumptions are here. Also, Olivier or John, in terms of your Medicare patient funnel, what are your expectations for the full year? I have a follow-up.
Suraj, let me start by commenting on the first part of the question. You are correct: we are seeing a strong ramp-up. We are not fully into Q2 commentary yet, but with the patient funnel and prior authorizations in place and the spillover from Q4 and Q1, April already translated into a very strong start. How fast we continue ramping will be defined by surgical scheduling and operating room availability, because we are working with high-volume sites and high-volume surgeons. April started very strong and shows the ramp is kicking in. I'll turn it over to John for the staging assumptions.
In terms of the ramp: we are looking at stepping up the ramp in the back half of the year for sequential quarter growth. So for Q1 to Q2 we are looking at 25% to 30% sequential growth, bumping that up to the low 40s in Q3 and then upper 40s to around 50% in Q4 to get to our total number for the year. That is how we are thinking about the staging of the ramp, Suraj.
And regarding Medicare percentage: in Q1 it was around 10% to 12%, still a minority. We expect this to continue growing as we scale, and I do think that toward year end it could be more in the range of 20%, though commercial payers will remain predominant. With C-coding in place, reimbursement is de-risked, and we've already seen the first two MACs integrate the C-codes in their Genio policies. We are looking with a lot of confidence into the rest of 2026.
Got it. And Olivier, in terms of Genio versus Inspire, what is the dynamic in the field in terms of device selection? A lot of sites have Inspire days booked—do you see early signs of patient selection migrating toward Genio? Is Genio displacing Inspire cases on HGNS days, or how are you squeezing your way in? Help us understand the current dynamic.
Suraj, that was one of the reasons we conducted the market research with 100 U.S. HGNS implanters to sanity-check our launch and referral strategy. It was encouraging: involving sleep physicians in patient selection and management—starting with CPAP-quit patients and continuing post-surgery—works well. When we train physicians we combine surgeon training with their sleep physician partners. Currently our DTC investment is limited, so most patients arrive for an HGNS solution but not specifically through Genio DTC. Conversion happens on site when options are explained; we see a high percentage spontaneously selecting Genio, driven by not having an implanted battery, bilateral stimulation, and software upgradeability. These findings were confirmed in our market research. We also saw the first therapy activations happen quickly; we do not need extensive adjustment to find the correct titration in most patients—the settings used during surgery are often appropriate—giving sleep physicians confidence to refer patients. We will continue focusing on high-volume implanters paired with their sleep medicine colleagues, ensure clear patient phenotyping before selection, and keep DTC spending limited.
One moment for the next question. Our next question will be coming from the line of David Rescott of Baird. Your line is open.
Great. Thanks for taking the questions. John, I want to follow up on the comments around gross margin. I believe you said there was a production yield issue in the quarter that has since been fixed or alleviated. Is that impact expected to continue into Q2 and then fully revert back in the back half of the year? I'm asking in the context of where you shake out for the full year—you could be somewhere in the mid-60s by the end of the year if you get to the upper end of that 60% to 62% range. So just trying to get a sense for what the adjusted cadence looks like through the year on gross margin. I had a follow-up as well.
Thanks, David. There will be a slight gross margin impact in Q2 because some of the units built in Q1 will flow through our P&L in Q2. The rest of the year we will start to see gross margin return to where we were in Q3/Q4 last year, which was in the low-to-mid 60s range. We expect to hang out around that level for the back half of 2026 before implementing Genio 2.2—the disposable patch and activation chip—which will provide a step-function improvement in 2027 into the low 70s.
Okay. And then thinking on the P&L: looking at the adjusted OpEx number for Q1 and relative to the guidance for the full year, if you annualize the Q1 number you’re pretty much getting toward the low end of the full-year non-GAAP guide. Why should we not anticipate a bigger step-up sequentially on the OpEx line? Is it fair to assume a lot of this SG&A investment is already in the business, or is more SG&A stepped up as sales increase? Are there offsets in R&D? And how should we think about stepping off into 2027?
Absolutely. We've been thoughtful about managing our cash runway and disciplined with cash operating expenses. A large driver of OpEx growth this year is the incremental investments in the U.S. commercial organization, which will run pretty consistently over the course of the year and underpins the four-times Q1 results to the low end of the guide. We will make selective investments during the year, and I would expect us to land somewhere in the middle of the guide range. We also made significant investments in 2025 across a number of supporting functions that we expect to leverage in 2026 as the organization scales, which reduces the need for incremental investments in some areas. Going into 2027, we will take the same approach—redeploy capital where possible, leverage non-commercial parts of the organization that have scale, and focus investments on growth and margin-improvement initiatives. We want to be conscientious about that.
Thank you. That concludes today's Q&A session.
And this also concludes today's programming. You may all disconnect. Thank you.