Good day, and thank you for standing by. Welcome to the Nyxoah third 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. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Pearson Dennis, Investor Relations Associate. Please go ahead.
Thank you. Good afternoon, everyone, and I welcome you to our third quarter 2026 earnings call. Participating from the company today will be Liam Kelly, President and Chief Executive Officer, and Loïc Moreau, Interim Chief Financial Officer. During the call, we will discuss our operating activities and review our third 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.
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 was filed with the Securities and Exchange Commission on March 26, 2026. With that, I will now turn the call over to Liam.
Thank you, Pearson. Good afternoon, everyone, and thank you for joining us. This is my first earnings call as President and Chief Executive Officer, and I am very pleased to be with you today. For those of you I have not yet met, let me briefly introduce myself. I bring more than 25 years of leadership experience in the medical technology industry, with a strong focus on commercial execution in the U.S. and international markets. During my time at Teleflex, I executed on significant product launches and expansions. These include products like EZ-IO, OnControl, GuideLiner, TrapLiner, Turnpike, UroLift, MANTA, Barrigel, and EZPLAZ. Many of these products are now the standard of care in their treatment modality. I also worked alongside a talented team to grow revenues, expand both growth and operating margins, and drive shareholder value.
Let me begin by thanking Olivier Taelman for his leadership over the past seven years. Olivier guided Nyxoah from clinical development through FDA approval and into our U.S. commercial launch. The foundation he and the team built is a large part of what drew me to this company. I am excited to join Nyxoah at this pivotal stage in the company's development for three primary reasons. First, Genio is a meaningfully differentiated therapy. Second, obstructive sleep apnea is a large and under-penetrated market. And third, we have a dedicated team that is capable of executing on our opportunity. I have had an excellent start to my time at Nyxoah. I have spent the last few weeks learning about the Genio product and its clinical differentiation, reviewing our go-to-market strategy, spending time with some key members of the team, and meeting some of our key customers to hear their perspective.
While it is still early in my onboarding process, a couple of things are clear. First, our employees are excellent. They are dedicated, driven, knowledgeable, and above all, patient-focused. They are eager to make Genio a successful product globally. They do not just want to be part of a great company; they want to help build a great company. Second, the Genio product is truly differentiated from the competition. It is the only bilateral HGNS therapy on the market. Our PMA submission, if approved, will not only allow us to serve more patients with complete concentric collapse, but will also significantly streamline the patient journey. CCC patients account for about one in four of the patients evaluated for this therapy and have no hypoglossal nerve stimulation option today in the United States. Third, we are executing well on our commercial launch in the U.S.
We have seen robust performance for a new product launch, and this is evidenced in our revenue trajectory. In addition, we continue to execute well in international markets. While I am still early in my new role, three short- to medium-term objectives are beginning to emerge. Number one is to refocus Nyxoah from an R&D and clinical development organization to a commercially centric organization. Number two is continuing to invest to drive penetration in the U.S. market while maintaining solid growth internationally. And number three is to continue to expand our gross margins and manage our operating expenses prudently. In summary, I believe there is substantial opportunity ahead for Nyxoah and that we have the right team to deliver the expected results as we work together to build a great company. Now, let me turn to a high-level overview of the third quarter.
U.S. net revenue was EUR 6.7 million, representing 29% sequential revenue growth. This is an acceleration from the 22% growth we achieved in the second quarter. Global net revenue was EUR 9.2 million, up 19% sequentially, and our international business continues to perform in line with our expectations. As we announced on October 19, we pre-announced revenue for the quarter and adjusted our full-year 2026 revenue guidance to a range of EUR 33 million-EUR 35 million. While we are disappointed to adjust our guidance, we are proud of the strong start to our commercial launch and acceleration in growth. The new guidance is based on U.S. revenues that are more reflective of historical ramps for a new technology, as physicians and centers build experience with Genio.
As I step into the role, I want to clarify that it is not our intent to systematically pre-announce our revenue on a quarterly basis. Despite the change in guidance, our foundations are strong. Physicians and OSA patients want a choice in hypoglossal nerve stimulation therapy. Genio is a differentiated product, and this has led to the growing number of trained surgeons and active accounts in the U.S., as well as positive feedback we receive on the Genio system. Our ACCCESS results and our PMA supplement submission could extend our differentiation in complete concentric collapse patients in the U.S. The U.S. launch remains the primary driver of our growth and our top priority. Our U.S. key performance indicators as of September 30, 2026, were strong. We trained 80 new surgeons in Q3, bringing the total to 342 surgeons trained on the Genio system.
We activated 53 new accounts in Q3, bringing the total to 233 active Genio accounts. We had 447 patients actively undergoing prior authorization in our Genio access program entering the fourth quarter of 2026. We continue to execute a focused launch. Today, we have 55 sales reps with 233 active accounts at the end of the third quarter. We will, of course, continue to activate new accounts, train new surgeons, but our focus on driving growth will be to go deeper in our existing accounts and drive utilization. Now for a reimbursement update. Our CMS and commercial payer coverage remain broad and stable, and our market access team continues to execute well on prior authorization submissions. In addition, CMS has published its final rule on 2027 reimbursement for the Genio procedure. Hospital outpatient reimbursement under C-code C8011 increases from $31,526 to $35,072, or approximately 11%.
Ambulatory surgical center reimbursement increases from $27,563 to $31,283, or approximately 13%. The facility increases strengthen the economic value of the Genio procedure. Clinical and regulatory progress was another highlight of the quarter. In September, we announced that our ACCCESS U.S. pivotal study met its core primary efficacy endpoints and its safety endpoints in patients with complete concentric collapse, or CCC. At 12 months, the Apnea-Hypopnea Index, or AHI, responder rate was 77.2%, and the ODI responder rate was 87.7%, both highly statistically significant, with zero device and procedure-related serious adverse events. The complete 12-month dataset was presented at the International Surgical Sleep Society annual meeting on October 15 and 16. CCC patients are currently contraindicated for commercially available unilateral hypoglossal nerve stimulation in the U.S. These OSA patients have limited treatment options today.
Genio has been approved for CCC patients in Europe since 2021, and we have now submitted a premarket approval, or PMA, supplement to the FDA to expand Genio's U.S. indication to include CCC patients. We have initiated a U.S. post-approval study called BREATHE, focused on building long-term real-world evidence for bilateral hypoglossal nerve stimulation in routine clinical practice. Now for an international update. We continue to execute in our focused markets with a disciplined approach. International revenue grew 42% compared to the third quarter of 2025. With that, I will now turn the call over to Loïc for a detailed review of our financial results. Loïc?
Thank you, Liam, and let me start with the top line. For the third quarter of 2026, net revenue was EUR 9.2 million, 365% growth over the third quarter of 2025, and 19% sequential growth over the second quarter of 2026. U.S. net revenue was EUR 6.7 million, representing 29% sequential growth over the second quarter of 2026. International net revenue was EUR 2.5 million, 42% growth over the third quarter of 2025. Gross margin in the third quarter of 2026 was 63.1% compared to 60.5% in the third quarter of 2025. This improvement in gross margin is being driven by spreading our cost of goods sold over a higher volume of devices. Total operating loss for the third quarter of 2026 was EUR 21.9 million compared to EUR 24.4 million in the third quarter of 2025.
As we transition to a commercial enterprise, we are shifting our spending away from clinical and R&D and towards investment in our commercial infrastructure. We remain committed to being disciplined with our spending as we seek to reduce our cash burn quarter-over-quarter. In term of cash, as of September 30, 2026, cash equivalents, and financial assets totaled EUR 77.1 million compared to EUR 97.8 million at June 30, 2026. With regards to guidance, for the full year 2026, we expect global net revenue in the range of EUR 33 million-EUR 35 million. We expect gross margin for the full year 2026 to be in the range of 60%-62%. With that, I will turn the call back to Liam.
Thank you, Loïc. Before we open the line, let me summarize our priorities for the coming quarters. Number one, deliver against our updated 2026 revenue guidance. We will do this by driving utilization in our existing U.S. accounts while continuing to train new doctors and expand into new accounts. Advance the CCC label expansion opportunity through the FDA review of our PMA supplement. Third, maintain financial discipline while investing behind our highest return and highest growth opportunities. We have a differentiated therapy, a large market, and a growing base of physicians who use Genio. Our focus now is to execute with discipline and to convert that adoption into increased procedure volumes. We remain confident in our ability to build durable growth in the United States and to improve care for OSA patients.
I wish to thank the board of directors for the opportunity to lead Nyxoah and the entire Nyxoah team for their execution this quarter and for the warm welcome I have received. With that, I would now like to open the line for questions and answers and hand it back to the operator.
As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Tommy Han from Baird.
Great. Thank you. Good afternoon, Liam and Loïc, and thanks again for taking the questions. Liam, congratulations on the new role. I know you're just a little over the month into the role now, but I wanted to ask what you're most excited about to tackle in your new role and what drew you to this opportunity.
Tommy, thanks for the question. What I'm most excited about is the opportunity in front of Genio to penetrate the U.S. market. I think that we are at an inflection point for the growth of the company in the United States, and that is what excites me, and obviously, that's what drew me to this opportunity. I think having bilateral stimulation is a differentiator. Hopefully, and we anticipate we'll get the PMA approval for CCC patients. That will improve workflow. It'll actually allow us to expand the market and to address roughly one in four patients that cannot be addressed today. As I went out on the road and I met with some of our key customers, they want an alternative out there. They are embracing the fact that there is a new technology on the market. They recognize that bilateral is a new option for them.
They recognize that CCC is an untreated pool of patients, and I think that they recognize that there is room. Look, there is room for two players in this market. There's room for three players. There's room for four players in this market. I think the more players that enter into this space, the better it will be for the patient, the better it will be for the doctors. It'll give people more choice. I think it'll ultimately expand the market. We've seen that happen multiple times in the history of medical devices, where a number of companies enter into the market. It doesn't contract the market, it actually expands the market. I think all the players will benefit in the long run, and ultimately, patients will benefit in the long run.
Great. Thank you. As a follow-up, with the updated guide and what seems like a new guidance philosophy, where do you think expectations should be heading into 2027? Maybe any first look you would be willing to provide us in terms of the cadence of sequential growth or otherwise in 2027? Thank you.
Yeah, Tommy, thank you very much for the question. Look, before I get into 2027 and the outlook for 2027, I think, first of all, I want to say I am pleased with the launch momentum in the U.S. If we just take a step back, we have now achieved an annualized run rate at Q3 of almost EUR 27 million or $31 million. That is best in class. It is encouraging and demonstrates the ability of Genio to penetrate the HGNS and OSA market and become, as I said earlier, an additive option in OSA patient care. As I said earlier, the CCC indication, if we get it, will be another milestone for us to address those patients. From a financial perspective, we expanded our gross margin by 260 basis points year-over-year and reduced our cash burn by EUR 2.5 million.
While I do not want to get into 2027, Tommy, we will get into that when we give our Q4, we report out in Q4 and give our guidance for the following year. I think the opportunity that is in front of Genio to grow into this market and to expand the market is very encouraging. We are bringing on new centers, we are training more docs, we are recruiting more reps. We now have 55 reps in the territory, and they are beginning to get very productive out there in the marketplace. Once we get through the fourth quarter and then we expect to hit our results, I think that will again show further progression as we head into 2027. I think investors should feel confident in our ability to achieve what we put forward for 2027.
Loïc, myself, and the entire team are going to be focused on execution, especially on the U.S. launch, but also to keep international growing at the same time.
Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. At this time, I am showing no further questions. This concludes today's conference call. Thank you for participating. You may now disconnect.