Nyxoah SA

Good day, and thank you for standing by. Welcome to the NCSOA First Quarter 2026 Earnings Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press Star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press Star 11 again. Please be advised that today's conference is being recorded. I now 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 2026 earnings call. Participating from the company today will be Olivier Talman, Chief Executive Officer, and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our first 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 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 factor section of our Form 20F, which was 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 our first quarter 2026 earnings call. Let me start with the Q1 2026 overview. The first quarter of 2026 marked 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 the first quarter of 26 versus the fourth quarter of 25. 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 the first quarter of 26 was consistent with the fourth quarter of 25, 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'm pleased to report that we grew our revenue by 13% sequentially over the fourth quarter of 2025. Let's now dig in in the U.S. commercial update. The U.S. launch remains the primary driver of our worldwide revenue growth and our key priority. During the quarter, we continued to execute on our focused commercial loan 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 nerve stimulation accounts entering Q2. I'm pleased to report on our U.S. launch key performance indicators as of March 31st, 2026. We have trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained on the geneal system. We have activated 34 new accounts in Q1, bringing the total of 91 active accounts out of our 125 targeted accounts. Active accounts are defined as surgeons trained and VAC committee approved. We have 241 new patients submitted under prioritization and still pending at the end of Q1. We have trained 50 new sales reps, bringing the 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 50 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 Asian anticoagulants beginning in Q2. We also recently conducted a market research study of 100 US hypoglossal nerve stimulation implanters. We learned that 88% of ENTs believe it is important to have multiple hypoglossal nerve stimulation options for their patients. All Genio-trained surgeons plan to adopt Genio in their practice. The top-sided 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 AGNS patients. The result of this market research confirms that our focused launch strategy on high volume hypoglossal nerve stimulation in plant 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 nerve stimulation 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 represent approximately 90% of our cases in QA. Coverage is broad and stable. GENIO claims continue to be processed under the CPT code 64568, or even under the CPT code 64582. depending on payer policy and individual case review. For example, United Healthcare recently added CPT-64568 back to their existing AGNS policy in parallel to CPT-64582, so both codes are available for AGNS. United Healthcare represents one of several commercial payers which have both CPT-64568 and the 645A2 listed as available codes for AGLS procedures, including GMO. Through the end of the first quarter, we maintained a 100% approval rate on 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 AG&S implants. On February 26th, however, CMS provided clarity by issuing AG&S specific C codes for facilities. Claims for GMO implantations are submitted under the C code C8011. This code represents a facility fee mapped to the APC level five at $31,526 in the hospital outpatient setting and $27,563 in the ASC setting. This is equivalent to the existing CPT code 60582 in hospital settings and slightly higher than the CPT code 60582 in the ASC setting. This results also in price parity at facility level for GENIO and competition. Next, from a physician fee perspective, claims continue being submitted under CPT645A2 at $722. 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 NCSOA is not advising to use of a modifier. As to the newly established WISER program, being an AI-supported prioritization tool rolled out by CMS in six different states since January 1st, 2026, we have achieved a 100% approval rate of our submitted Medicare patients. The fact that reimbursement didn't hinder our Q1 launch momentum is the result of the expertise of our market access team the collaborations with experts in that field, our participation in the FDA early payer feedback program, and the proactive education of all our customers. Because of these factors, we expect continuity for 26 and into 2027. As part of the ongoing CPT editorial panel discussion regarding the future of AG&S coding, The panel has indicated that there is no intention to leave any AGNS technology orphaned without appropriate coding. For 2028, we understand that there are currently two paths to support continued coding being dedicated CPT codes for the different AGNS technologies or creating a comprehensive AGNS coding set. Following the model laid out in the CMS C codes, we learned that competition 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 AG&S space, creating a comprehensive AG&S code set. We will take our lead on 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 UK and the Netherlands. However, we maintained a disciplined financial approach, focused on reaching break-even, 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.