Nyxoah Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 5, 2026

Key Takeaways

  • Positive Sentiment: U.S. commercialization accelerated: Q2 worldwide revenue rose 21% sequentially to €7.7 million, including 22% U.S. growth to €5.2 million. Active U.S. accounts doubled to 180, while 427 patients were under prior authorization entering Q3, up 77% sequentially.
  • Positive Sentiment: Reimbursement support strengthened: CMS proposed 2027 reimbursement increases of approximately 12% for hospital outpatient facilities and 15% for ambulatory surgery centers for Genio procedures. Nyxoah also reported a 100% prior-authorization approval rate across commercial, Medicare Advantage, and WISeR-submitted Medicare patients.
  • Positive Sentiment: Balance sheet improved materially: The company secured $110 million through a $95 million equity raise and a $15 million EIB loan drawdown, providing funding to expand its U.S. sales organization and patient-funnel initiatives.
  • Neutral Sentiment: Full-year guidance was maintained: Nyxoah continues to expect 2026 revenue of €36 million–€40 million and gross margin of 60%–62%, with U.S. revenue expected to grow sequentially in both Q3 and Q4 while international revenue remains broadly stable.
  • Negative Sentiment: Operating expenses remain elevated: Q2 operating expenses increased to €25.1 million, including higher selling, general and administrative costs from the U.S. commercial build-out, while the company reported a €20.6 million operating loss. Full-year operating-expense guidance increased by €1 million to €99 million–€102 million due to a one-time share-based compensation charge.
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Earnings Conference Call
Nyxoah Q2 2026
00:00 / 00:00

There are 8 speakers on the call.

Operator

Good day. Thank you for standing by. Welcome to Nyxoah's second quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. Today's conference is being recorded. I will now hand the conference over to your first speaker today, Pearson Dennis, Investor Relations Associate. Please go ahead.

Speaker 1

Thank you. Good afternoon, everyone. I welcome you to our second quarter 2026 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 2026 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.

Speaker 1

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 the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F, which was filed with the Securities and Exchange Commission on March 26th, 2026. With that, I will now turn the call over to Olivier.

Speaker 2

Thank you, Pearson. Good day, everyone. Thank you for joining us for the second quarter 2026 earnings call. Let me start with Q2 highlights. Q2 was a strong quarter for Nyxoah across multiple fronts. I'm pleased with the progress we are making in the business. First, the strong commercial execution of our U.S. launch delivered a second consecutive quarter of more than 20% sequential U.S. revenue growth. U.S. net revenue was EUR 5.2 million, up 22% over the first quarter of 2026. We also posted another strong quarter of revenue growth in our international business, up 19% over the first quarter of 2026. On a worldwide basis, net revenue was EUR 7.7 million in the second quarter, representing 21% sequential growth over the first quarter. Second, before doing a deeper dive on the U.S. commercialization results, let me provide our high-level leading U.S. commercial indicators.

Speaker 2

Our U.S. leading commercial indicators continued to strengthen across the board. Entering quarter two with 40 fully trained sales reps, we can cover 200 of the top 400 high-volume hypoglossal nerve stimulation accounts in the U.S. We have trained 55 new surgeons and activated 89 new accounts in this quarter, doubling our active account base to 180. We entered the third quarter with 427 patients actively under prior authorization, a 77% increase over the prior quarter. Our prior authorization approval rate remains at 100% for both commercial payers and patients submitted via the WISeR program. On the reimbursement front, CMS announced meaningful proposed increases for AGNS overall, including Genio specifically. CMS-proposed facility reimbursement would increase OPPS facility payment by 12% and ASC, ambulatory surgical centers, by 15% for 2027. These increases would further strengthen the economic value of the Genio procedure for the facilities.

Speaker 2

From a financing perspective, we significantly strengthened our balance sheet by securing $110 million during the quarter, taking away the financial overhang. This new capital will provide us with the resources needed to further accelerate Genio U.S. commercialization ramp and implement the growth initiatives focused on increasing the patient funnel. Digging in deeper into the U.S. commercialization. The U.S. commercial launch remains the primary driver of our long-term company success. Our U.S.-focused strategy remains unchanged and centered on driving strong Genio adoption in the top 400 high-volume AGNS accounts, which represent approximately 70% of the total U.S. AGNS volume. We hired and trained 50 new sales reps in the first quarter, bringing us to 40 sales territories as of April 1st. Entering Q2, we have access to 200 of the top 400 high-volume AGNS accounts.

Speaker 2

Specifically, we trained 55 new surgeons in Q2, bringing the total to 262 surgeons trained on the Genio system. We activated 89 new accounts in Q2, roughly doubling our active account base, bringing the total to 180 active high-volume AGNS accounts. Finally, we had 427 patients actively under prior authorization submissions entering the third quarter of 2026. This is a 77% increase over the previous quarter. Doubling our active account base to 180 high-volume AGNS accounts in a single quarter demonstrates that both facilities and physicians are embracing Genio and confirms success of our patient referral pathway by sleep physicians. With 427 patients actively under prior authorization exiting Q2, this gives us first-hand confirmation of increased patient demand and is a key leading indicator for Q3 of the acceleration of our patient pipeline, giving us confidence in continued launch momentum entering Q3. Next, reimbursement.

Speaker 2

There is now full clarity for Genio reimbursement with the dedicated Medicare C code C8011 for Genio. Our commercial payer coverage remains broad and stable using existing CPT codes. Our market access team continues to execute strong on supporting prior authorization submissions. Through our Genio access program, we continue to see 100% approval rates of commercial payers, Medicare Advantage, and Medicare patients under the WISeR program. Commercial payers are still the majority of our business, making up approximately 85% of it. The recent direction of CMS proposed rule for 2027 AGNS reimbursement would positively impact the clinical and economic value of the Genio procedure in OPPS and ASCs. Specifically, CMS is proposing to increase hospital outpatient reimbursement for the Genio procedure under C code C8011 from $31,526 to $35,414, or an increase of approximately 12%.

Speaker 2

CMS is also proposing to increase ambulatory surgical centers, the ASCs, reimbursement from $27,563 to $31,722, or an increase of approximately 15%. These proposed increases are amongst the strongest within APC 5465, the level 5 neuromodulation category. Finally, in the upcoming September CPT Editorial Panel meeting, AAO-HNS, supported by Nyxoah as an industry member, will continue the discussion of a comprehensive AGNS coding. As a consequence, Nyxoah did not submit Genio for a dedicated category 1 CPT code on the September CPT Editorial Panel meeting agenda. Let me now focus a little bit more on our recent Investor Day. On July 8th, we had the pleasure of hosting our Investor Day, where we focused on bringing together leading ENT surgeons and sleep physicians alongside independent reimbursement experts. The surgeons shared their first-hand implant experience with Genio, and both surgeons and sleep physicians confirmed strong airway openings on activation.

Speaker 2

These real-time experiences are the key drivers behind Genio's adoption in their practice. The reimbursement experts presented their view of the AGNS reimbursement landscape, confirming the durability of long-term coverage and Genio's strong positioning under every future coding scenario. The event reinforced the two pillars of our U.S. launch, growing physician adoption and a solid reimbursement foundation. For those who missed it, the replay is available on our investor relations website. International. Before turning to the financial, let's look at the international markets. We accelerated revenue in the second quarter, resulting in a 19% growth quarter-over-quarter. Overall, in the first half of 2026, we almost doubled our international revenue versus the first half of 2025, driven by our focused commercial approach in target geographies.

Speaker 2

In Germany specifically, as the largest AGNS market outside the U.S., we first entered this market back in 2023 as our commercial proof of concept, resulting today in a stable AGNS market share of up to 25% overall, with a market share in our top high-volume accounts of above 50%. In the U.K., we entered the market at the same time as competition in late 2024, and in our initial accounts, we are seeing market shares above 50% as well. In the Middle East, Nyxoah is the sole AGNS provider, and we continue to further expand. We recently entered the market in the Netherlands. Our strategy remains unchanged. Exercise financial discipline in these markets with a goal of driving growth and breaking even in our international business, which we've been able to do already in Germany.

Speaker 2

With that, I will now turn the call over to John for a detailed overview of our financial results.

Speaker 3

Thank you, Olivier. For the second quarter of 2026, worldwide net revenue was EUR 7.7 million, which represents 21% sequential growth compared to the first quarter of 2026 and compares to EUR 1.3 million in net revenue in the second quarter of 2025. U.S. net revenue was EUR 5.2 million, representing 22% sequential growth over the first quarter of 2026. International net revenue was EUR 2.5 million, representing 19% sequential growth over the first quarter of 2026. For the six months ended June 30, 2026, worldwide net revenue was EUR 14 million compared to EUR 2.4 million for the six months ended June 30, 2025, an almost six-fold year-over-year increase, primarily driven by our U.S. commercial launch. Gross margin in the second quarter of 2026 was 60%, compared to 57% in the first quarter of 2026.

Speaker 3

Research and development expenses were EUR 9.5 million in the second quarter of 2026 compared to EUR 10.1 million in the second quarter of 2025, due to a decrease in product development expenses. SGA expenses were EUR 15.6 million in the second quarter of 2026 compared to EUR 10.7 million in the second quarter of 2025. This increase was primarily driven by the continued build-out of our U.S. commercial organization. Total operating loss for the second quarter of 2026 was EUR 20.6 million and remained relatively flat compared to EUR 19.9 million in the second quarter of 2025. Please note that our operating expenses in the second quarter of 2026 included a one-time non-cash share-based compensation charge of approximately EUR 900,000 due to the repricing of employee equity incentive awards. Non-GAAP cash operating expenses were EUR 21.8 million, or essentially flat compared to EUR 21.7 million in the first quarter of 2026.

Speaker 3

Non-GAAP cash operating expenses increased from EUR 19.8 million in the second quarter of 2025, primarily due to the investments in our U.S. commercial organization. During the second quarter of 2026, we secured $110 million in aggregate financing via a $95 million equity raise and the drawdown of the second tranche of our EIB loan in the amount of $15 million. This additional cash removes the near-term financial overhang that had been a concern for investors and gives us the capital to scale our U.S. commercial business. As of June 30, 2026, cash and cash equivalents plus financial assets totaled approximately EUR 97.8 million. I'll turn to guidance. For the full year 2026, our full-year revenue guidance remains unchanged, and we continue to expect worldwide net revenue in the range of EUR 36 million to EUR 40 million. We continue to expect gross margin in the range of 60%-62%.

Speaker 3

We now expect total operating expenses in the range of EUR 99 million to EUR 102 million, an increase of EUR 1 million due to the one-time share-based compensation charge recorded in the second quarter. We continue to expect total non-GAAP cash operating expenses in the range of EUR 88 million to EUR 90 million. Non-GAAP cash operating expenses reflect expected total operating expenses less non-cash items such as depreciation, amortization, and share-based compensation expense. We continue to target long-term gross margins above 80% and believe our disciplined approach to operating expenses supports revenue breakeven below EUR 150 million in revenue. I'll now turn the call back over to Olivier.

Speaker 2

Thank you, John. As we enter the second half of 2026, our priorities remain clear. First, accelerate investment in our U.S. commercial organization in quarter three by further expanding from 40-55 territories and implement growth initiatives focused on increasing the patient funnel. Second, continue to execute on our focused U.S. loan strategy, targeting the top 405 volume AGNS accounts. Third, maintain a disciplined financial approach to OpEx and direct investments towards revenue growth drivers. Before closing, I would like to thank all Nyxoah employees for their contribution in making the second quarter once more a successful one. With that, I would now like to open the line for Q&A.

Operator

Thank you. Ladies and gentlemen, if you would like to ask a question at this time, you will need to press star 11 on your telephone and wait for your name to be announced. To remove yourself from the queue, simply press star 11 again. One moment for our first connection. Our first question coming from the line of Adam Maida with Piper Sandler. You'll listen now, please.

Speaker 4

Hi, this is Kyle Winborn on for Adam. Thanks for taking our questions and congrats on the progress. I guess first I just wanted to ask about the quarterly cadence, if we could, with the revenue guidance. Is there any additional color you can give us on how you expect the remainder of the year to break out, kind of between Q3 and Q4? Obviously understanding amidst the ramp for the launch that it should kind of continue to grow sequentially. Just anything you can help us with there, and maybe you can just talk through your confidence level of achieving the guidance?

Speaker 3

Sure, absolutely. I'll start with that part. First, Kyle, I guess with regard to what we see in the funnel with regard to new surgeon training, VAC committee approvals, as well as the number of pre-authorization patients that are in that position entering Q3. We're comfortable with the guidance for the full year of EUR 36 million-EUR 40 million, which reflects, based on our first-half revenue, a range of EUR 22 million-EUR 26 million for the second half of 2026. We would expect that revenue in the U.S. to grow sequentially from Q2 to Q3, then again from Q3 to Q4. From an international perspective, we expect it to be consistent in the back half of the year as compared to the first half of the year.

Speaker 4

Okay, great. That's helpful. Then maybe just as my second question, on the ACCESS study, we talked about this a bit on the Investor Day. Just wanted to check in to make sure everything went well. I think you were planning to wrap patient follow-up shortly after the Investor Day, which would've been a couple of weeks ago. Just to confirm if you're still expecting initial data, I think you were saying at or around the ISSS meeting. If you're still on track for the PMA supplement for Q4 label expansion early next year. Thanks.

Speaker 2

Thank you for the question. I'm happy to also share here some very positive news. We are finalizing the 12-month data as we speak. We are preparing for the PMA supplement submission. For ISSS, we just received the news that the podium presentation has been accepted for the CCC data. We will release all the CCC data during the ISSS Congress on podium. I invite everyone to attend to be present. When it comes to the submission, also there, we stay fully on plan. We are finalizing our 12-month data. We are planning to get them submitted end of Q3, latest beginning Q4. There is the 180 days FDA review. We accept, as we disclosed already previously, somewhere during the end of Q1, maybe beginning Q2, latest in 2027, a positive result and also CCC added to our label.

Speaker 4

Great. Thank you guys.

Operator

Thank you. Our next question in queue, coming from the line of Suraj Kalia with Oppenheimer. Your line is now open.

Speaker 2

Hi, Suraj.

Speaker 5

Hey, Olivier. Can you hear me all right?

Speaker 2

Yes. No, we can. Hello. Good afternoon.

Speaker 5

Good afternoon. Hey, Olivier, in terms of your prior authorization cadence, the numbers that you give exiting the quarter, how should we think about the cadence of these prior auths? We can reverse engineer some of the implants, U.S. implants that are being done in the quarter. I'm more curious in terms of how much time are you all seeing for prior authorization from start to finish, and if there's a specific cadence as the quarter progresses, just so that we can map it out for the next few quarters.

Speaker 2

Yes. This is a very interesting question. First of all, with 427 submitted prior authorizations entering quarter three, just to give some color, this is a significant increase of 77% compared to the number of prior authorizations we had entering Q2. In absolute numbers, entering Q3, 427. If we go back in time, entering Q2, we had 241. That being said, next question is, how fast can a prior authorization result into an actual implant? I'm sure if you do the math on sales, we end with approximately 240 devices that were sold. If you calculate Q1, we had roughly 240 prior authorizations that were transferred in Q2. Is this exact science? No, it's not. Ballpark, we see that the majority, as we consistently communicated, that we transfer will also result in actual implants in the next quarter.

Speaker 2

I hope this is answering the question, Suraj.

Speaker 5

Got it. Olivier, our math is suggesting in Q2, you all did roughly 240 implants. I'm curious, out of the 180 active sites, what do you think this translates into your share? Are the 240 just in a certain subset of those active sites, really, and the remaining really have to, even though they are active, have to really start contributing? Any additional color would be great. Thank you.

Speaker 2

Yes. Another very interesting question. We were talking about having on average 15% market share in the sites where we are present when we exited, in fact, Q1. We can see that overall, we are maintaining this 15%, but note that we have opened 89 new sites in Q2, which are fresh, which are gaining their first experience. We can also report that the longest-standing accounts are showing market shares above 15%, and I'm even happy to share that our top account is passing already the 44% of market share. This is really promising. If you see how fast we are opening new accounts, and then also if you see how the longest-standing accounts, due to reordering and confidence in Genio, are showing stronger growth in market share than the 15%.

Speaker 5

Got it. Hey, Olivier, one last question, forgive me. Did I hear you correctly? You all have not paired with Inspire for the C code submission for the September editorial meeting?

Speaker 2

Yes, this was correct. We are very transparent in this. We participate as an industry partner. We are supporting also the discussion, the lead of the AAO-HNS, and they are talking about a comprehensive coding. For September, we continue to support this approach, and we did not submit it for a dedicated code.

Speaker 5

Got it. Thank you.

Operator

Thank you. Our next question coming from the line of David Brisco with Baird. Your line is now open.

Speaker 6

Oh, great. Thanks for taking the questions. I wanted to ask about the new center adds, the trained new physicians that you have. I think you pretty much doubled the account base in Q2. That's a pretty significant step-up of course, but trying to get a sense out of the line of sight accounts, high-volume accounts that you've laid out there. Maybe how or why, or what, I guess, we should be thinking about on a go-forward basis, at least in the back half of the year, as it relates to the number of new centers you're expecting to bring on per quarter. Maybe what that sets you up for into 2027. Then, from a utilization perspective, where or again, how would you expect utilization to kind of track in the near to intermediate term?

Speaker 2

Yeah. No, David, thank you for the question. First of all, we have a focused launch strategy focused on the top 400 high-volume AGNS accounts in the U.S. To your point, we showed very strong results in Q2 by doubling the number of active accounts, bringing it to 180. To answer your question, we have to link this also with the number of territory managers or sales reps that we are having. We have 40 entering Q2. I communicated already a couple of times that on average, our sales reps, they have five of those high-volume accounts. With 40 reps, it's easy mathematics. You can cover up to 200 high-volume sites. Today, exiting Q2, we already have 180 who are active. Going forward, we also are hiring again a new cohort of 15 sales reps.

Speaker 2

That will bring our total to 55. You do the same math, you see that we can go in quarter three, quarter four, up to 225 to 230 implanted high-volume accounts with our current sales force. That's one thing that we are doing. The next thing, also asking on productivity. In our strategy, the strategy is going deep. Therefore, I'm extremely pleased also to see that we capture overall in all our accounts, an average already of 15% market share. I think more important is that we can see the accounts that were opened up already in Q4 or early Q1, that they are already going beyond the 15% market share, and that we already have a top account where we go above 40% market share.

Speaker 2

All this is confirming that facilities, surgeons, and patients are embracing Genio. I think that is the key takeaway message. We are growing extremely fast in the volume of accounts. We also have more than 262 surgeons trained. Again, showing the excitement of surgeons. What to expect in the second half, the quote will be more or less reaching 225 to 230 accounts in the second half of 2026. As we continue investing in hiring more salespeople, this goal also goes hand-in-hand with having more accounts that we will open. It's not our strategy to open 1,000 accounts. Our strategy stays to get as fast as we can to the 400 high-volume implanting accounts that we see across U.S.

Speaker 6

Okay. That's helpful. Maybe just thinking about this, the other pieces of the guide for the year. To hit the gross margin line, it's a pretty significant step-up in the back half of the year. Can you help us think through the moving pieces and your level of confidence behind hitting that? When you think about this EUR 88 million-EUR 90 million of non-GAAP OpEx expense in the back half of the year, where should we be thinking about the bigger incremental dollar spend coming from in the second half of the year? Meaning, what are you more so expecting to invest behind to drive this broader sales growth versus what's already kind of baked into the core of the business? Thank you.

Speaker 3

Yep, sure. Absolutely, David. For the back half of the year, from a gross margin improvement perspective, we have ongoing projects that continue to drive gross margin up. These are small in nature. For one example, the ES, which is a component of the device that's going to be removed in the second half of the year in the U.S. That's going to help drive gross margin up to those levels. We continue to increase our yields over the course of the year as we continue to produce products. Those are the near-term drivers for 2026 in the back half of the year. In terms of OpEx spread

Speaker 3

I would anticipate in the third quarter, you'll see a bit of a sequential step-up from the second quarter, but more of the expenditures will be coming in the fourth quarter when we have a full quarter's worth of U.S. sales rep expansion baked into that fourth quarter. A bit of step-up Q3 expense-wise, but more of it in Q4 to get to that full year EUR 88 million-EUR 90 million number.

Speaker 6

Okay, thank you.

Speaker 2

You're welcome.

Operator

Thank you. Again, as a reminder, to ask a question, please press * one. Our next question in queue coming from the line of Jonathan Block with Stifel. Your line is now open.

Speaker 7

Hey, everyone. Joe Federico on for John. Thanks for taking the question. Maybe just to circle back to reimbursement for a second. I know you mentioned that you have not submitted for a dedicated code, your competitor seemingly has submitted an application for review at the panel next month. Can you maybe just give us a sense of what your strategy would be like in the range of outcomes if their package is approved or denied, or just where are you thinking you go from there?

Speaker 2

Definitely, Joe. First of all, I would like to start by pointing out that today the environment for hypoglossal nerve stimulation reimbursement is stable and supportive, and that with Genio, we have a dedicated code, the C8011, that is in place. Also for commercial payers, we see that there is clarity on the CPT codes that they are using, and we are also seeing that we have 100% prior authorization. That is the starting base. Next, I do think that the discussions that are ongoing in the editorial panel are extremely constructive. We see that the AAO-HNS is really taking the lead and is also trying to find and to discuss together with AMA, finding the most optimal solution for AGNS in the future, coming to a comprehensive coding as part of this strategy.

Speaker 2

If that strategy is followed, the first comprehensive coding clarity would be effective in play January 1st, 2029. Going back to competition. Yes, they went and they submitted in September for a dedicated code. They also did the same thing in April. Just as a reminder, in April, this was rejected, so they have resubmitted. Our strategy with Genio stays and remains unchanged. We support the AAO-HNS, and we do want to follow and give our full support in also going to a comprehensive AGNS coding. Because there is a coding in play, there is no risk at all. In moving forward, we will see how the future will further evolve.

Speaker 7

Okay, that's really helpful color. Maybe just a quick follow-up just on, you mentioned the 40 trained sales reps entering the quarter and that the plan is to add the next tranche of 15. Maybe just as we sit in August, how's that hiring progressing? When do you think those additional reps will be trained and in the field being fully productive?

Speaker 2

Yes. As I mentioned also in earlier calls, we have a high demand of salespeople who want to join Nyxoah, and this has continued. We are currently actively doing the interview process. We expect that we have all 15 onboarded definitely by the end of quarter three. We will start doing their training beginning Q4 so that we can still get them active selling even during Q4, and definitely have a full selling and trained sales force of 55 people going in January 1st, 2027.

Speaker 7

Great. Thank you.

Operator

Thank you. At this time, we have no further questions in the Q&A queue. Ladies and gentlemen, this concludes today's conference call. We thank you for your participation, and you may now disconnect.

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