Nyxoah SA

Good day and thank you for standing by. Welcome to the NCSOA third quarter 2025 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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I want to attend the call over to your speaker today. Pearson Dennis, please go ahead.

Thank you. Good afternoon, everyone, and I welcome you to our third quarter 2025 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 third 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 20F filed with the Securities and Exchange Commission on March 20th, 2025. 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 third quarter 2025 earnings call. Since FDA approval on August 8th, our U.S. launch activities following FDA approval of Genio have generated strong enthusiasm across the EMT and sleep communities. Physicians welcome the long-awaited optionality now available to their OSA patients and the end of a single solution market. During the recent International Surgical Sleep Society, IFFF meeting, our Genio Symposium and educational event drew a full room of clinicians eager to engage with real-world case discussions and share perspectives. These discussions reflected what we continue to observe globally. Clinicians' value choice in treating obstructive sleep apnea and their differentiated, bilateral, patient-centric design resonate strongly with both surgeons and sleep physicians. We were particularly encouraged as well as the strong clinical results demonstrated in the DreamStorm. Many providers highlighted the opportunity to tailor treatment based on individual patients' needs and expressed appreciation for our approach to chronic disease management, patient feedback integration, and multidisciplinary care pathways. Finally, our first commercial Genu implant in the U.S. completed as early as September represented an important milestone for our teams and partners, already generating $231,000 in revenue during the third quarter and ahead of our expectations. Early service feedback has emphasized streamlined patient management, close collaboration between EMTs and sleep physicians, and strong patient follow-up engagement. While still early, this reinforces our confidence is well positioned to serve U.S. OSA patients with a compelling new alternative. We are navigating the critical steps of early commercialization and the momentum we are generating in training physicians, obtaining value analysis committee approvals, and securing coverage for major public and private payers is extremely encouraging. In our initial launch strategy, With 25 territory managers, we are focused on the initial 125 of the top 400 high-volume hypoglossal nerve sites representing roughly 75 to 80% of the total AGMF volume. We are actively tracking a number of leading indicators to measure our early progress. Since launch until end of October, We can report that out of the 125 targeted accounts, 111 surgeons have already successfully been trained on GLEO. Second leading indicator, 102 value analysis committee submissions have been completed, of which already 35 approvals have been received. Reimbursement has been secured with Medicare and 10 private payers already. including United Healthcare, Blue Cross Blue Shield, and Cigna. 63 prior authorizations were submitted. 21 approvals have been already received with a 100% success ratio. In all of these approvals, the CPT code 64568 was accepted. 15 implants were already successfully performed across 9 accounts in the first 4 weeks. Beginning on the road since the launch and interacting with surgeons, I've been incredibly encouraged by feedback I'm hearing. Surgeons are enthusiastic to finally have a second AGNS option to offer to their oversight patients. They commented that GEO is unique and differentiated as a solution, which resonates very well with patients seeking therapy. with bilateral stimulation. They report that Regenio procedure is efficient with procedure times up to 60 minutes on average. In conclusion, first interaction Regenio was positive. Surgeons are excited to incorporate Regenio solution into their daily practice. On the reimbursement side, we have made significant progress. Our GenioXS program provides dedicated support to our customers for prior authorizations. Each territory manager works with a dedicated case manager who interfaces between the clinical team, patient, and sales team. The program includes a reimbursement helpline and communication portal for real-time tracking. To date, we have achieved 100% approval on all our prior authorization submissions through our GenioAccess program, including with 10 key private payers, such as United Healthcare, Blue Cross Blue Shield, Healthcare Service Corporation, Anthem, and Cigna. In addition to providing this direct support to our customers, we are also seeing progress with commercial payer policy decisions. Healthcare Service Corporation, or HCSC, operates Blue Cross Blue Shield plans in Illinois, Texas, Oklahoma, New Mexico, and Montana. HCSC and Blue Cross Blue Shield of Michigan has updated the Hippoglossal Nerve Stimulation medical policies to already include CPT code 64568 as a reference procedure code. While coverage of Hippoglossal Nerve Stimulation was already established, the inclusion of this code provides additional clarity for providers and payers. which the company expects will help reduce administrative barriers and streamline patient access. HCSE and BCPS of Michigan represent over 26 million members across six states. We continue engaging with additional commercial payers and expect continued progress on coverage decisions in the coming quarters. Looking ahead, our priorities are clear. We will continue expanding our U.S. commercial organization, adding territory managers to deepen coverage of high volume implanting centers. Training programs are scheduled through year end with a strong pipeline of surgeons requesting implant slots. Beyond the U.S., we are focused on driving deeper penetration in Germany and in the United Kingdom, where we maintain a strong presence. And in the Middle East, where we hold exclusive status as the only available AGNS solution, while selectively expanding into additional geographies with strong demand for differentiated technology. This is an exciting time for MixOA. We have the team in place We have surgeon demand, we have payer coverage, and most importantly, we have patients choosing Genio. In the fourth quarter, we are focused on execution, training more surgeons, activating more records, and treating more patients. With that, I will now turn the call over to our CFO, John Lombry, for a financial update.