Nyxoah SA

Hello and welcome to NextL's second quarter 2025 earnings conference call. At this time all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during the session, you would 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 again. I will now like to turn the conference over to Kirsten Dennis. You may begin.

Thank you. Good afternoon everyone and I welcome you to our second 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 second quarter 2025 financial results released after US 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 our risks and uncertainties associated with our business, please refer to the risk factor section of our Form 20-F 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 our second quarter 2025 earning call. I'm extremely proud to announce that we received FDA PMA approval for our Genio system in the United States. This result was the culmination of persistent, strong regulatory and clinical execution supported by the entire passionate and committed NixSola team. For US patients suffering from obstructive sleep apnea or OSA, the Genio system provides them with a significant advance from currently available treatment options. For physicians, they now have a choice to select the optimal Agenes therapy for their patients. For NixSola, it marks the beginning of an exciting journey in the US. This PMA approval confirms the safety and effectiveness of our innovative technology and authorizes commercial distribution in the US, which now has actively begun. The Genio system becomes the first and only bilateral Agenes therapy approved in the US for treatment of OSA. It's also important to note that the Genio system is not contraindicated for patients suffering from complete concentric collapse or CCC. Another key differentiator represented in our label highlights our ability to treat patients with positional OSA. This is important as according to published data, a patient's AHI score can double when a patient sleeps in a supine position or on their back. Having this in our label serves as a validation of the clinical outcomes for more pivotal dream study, which met its primary endpoints regardless of a patient's sleep position. Also note that complete concentric collapse or CCC is not contraindicated, but is included as a warning in the company's label as the safety and effectiveness for patients suffering from CCC has not yet been established for the Genio system based on US specific clinical data. Our goal is however to make Genio available for US patients suffering from CCC as soon as possible. Therefore, we strategically elected to stop enrollment in the ACCESS study. We believe that the number of patients enrolled in ACCESS will have enough statistical power to draw meaningful conclusions on our effectiveness for complete concentric collapse patients. In addition, we see great results in real life data from patients in Europe where our CE mark already includes an indication for CCC patients. I'm also pleased to report that our dream study was published by the Journal of Clinical Sleep Medicine, which is a leading journal for the sleep community. I'd like to highlight a couple of data points that were published for the first time, which demonstrate a high level of patient satisfaction. The device demonstrated compliance of .9% and the patient satisfaction was scored at 90%. This data confirms our early experience in Europe and we believe the publication of the dream study will strengthen our US knowledge. And will also give us access to new international markets. Immediately upon receiving FDA approval, we started our focused US launch with a commercial organization with over 50 highly talented and experienced professionals. This team is now executing on our two-pronged launch strategy. They will target high volume hypoglossal nerve stimulation and planting centers where they will position GENIO, a differentiated option for patients suffering from OSA. And they will focus on developing strong referral networks with sleep physicians managing large populations of moderate to severe OSA patients who quit CPAP but are in need for treatment. Our US sales team is already actively engaging with these targeted sites, working through the Value Analysis Committee and pre-authorization approval processes. From a launch execution perspective, I am very pleased to report that already in the first week we received several VAC and pre-authorization approvals. It's also very exciting to see multiple physicians with patients lined up who are running quickly to become the first to implant GENIO commercially in the US. Regarding reimbursement, we have identified the use of CPT code 64568, which has been recognized by commercial and government payers for the OSA indication. This is the same CPT code used by our competitors, and we feel confident that we will be able to differentiate ourselves via our unique technology benefits and patient focus. As a result of our ongoing work with the American Academy of Auto Longeology and participation in the FDA's Early Payer Feedback Program, educating CMS and major commercial payers on the clinical impact GENIO can have on their OSA patients, positions as well for acceptance of pre-authorization submissions in the near term and favorable coverage decisions in the long term. With over 100 physicians in the US already trained and additionally weekly training sessions scheduled, there is strong momentum building in the medical community. Our initial traction in the marketplace is demonstrated by the many physicians lining up patients for a GENIO implant in just our first week of commercialization. This early interest gives us confidence in the success over the US Lodge. We have also identified demand from patients who are hesitant about receiving an implanted battery, which requires the need for subsequent surgery to replace this battery. The GENIO system addresses this need with its unique and less invasive design. There has recently been a lot of discussion on the potential impact of GLP-1 on the AGNS market. Contrary to our competitors, we have strategically limited our patient population to those with a BMI below 32, since that is where the efficacy for GENIO is proven. As a result, we believe that the eligible GENIO patient population will grow, not shrink. This belief is based on survey study data showing GLP-1's ability to bring patients with high BMI of 37 and above down to a BMI level where clinical data demonstrates that GENIO is effective. Without GLP-1, we would never be able to treat this high BMI patient population. While there might be patients with lower BMI's dropping out of the potential AGNS patient population, this will be out-weighted by a significant number who becomes eligible for AGNS. On another topic, prior to GENIO FDA approval, Inspire Medical initiated a patent lawsuit against Nixoa. Since Nixoa was founded, we have invested significantly in our IP portfolio and we will vigorously defend ourselves in this matter and have the means to do so. This patent lawsuit will not impact our US commercial launch, which is already underway and generating a lot of enthusiasm in the marketplace. To conclude my opening remarks, I want to emphasize that the FDA approval marks a pivotal moment for Nixoa. Our bilateral stimulation technology offers a truly differentiated solution that makes us unique for patients. We believe GENIO can fundamentally improve the quality of life of all our patients by giving them a good night's sleep. With the current ongoing momentum and physicians already lining our patients for GENIO, we are confident in our ability to execute a successful US launch. With that, I'll turn the call over to our CFO John Laundrie for a financial update.