Nyxoah SA

Good day, and thank you for standing by, and welcome to NCSAW Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-on 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 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. Now, like the hands I would now like to introduce your host for today's call, Michaela Kirkwood, Investor Relations and Communications Manager. Please go ahead.

Thank you. Good afternoon and good evening, everyone, and welcome to our earnings call for the second quarter of 2023. I am Michaela Kirkwood, Investor Relations and Communications Manager at Nixella. Participating from the company today will be Olivier Tillman, Chief Executive Officer, and Lalique Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our second quarter financial results released after U.S. market closed 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 event section of the investor relations tab of our website. Before we begin, I would 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 statements involve material risks and uncertainties that could cause actual results or events to material 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 statements. For a list of descriptions 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 22nd, 2023. With that, I will now turn the call over to Olivier.

Thank you, Michaela. Good afternoon and good evening, everyone. And thank you for joining us for second quarter 2023 earnings call. The evolution of Nixovas enlarging its US footprint is well underway, with our current focus on patient follow-up in our US pivotal study dream. As a reminder, we completed all 115 implants in the study earlier this year and expect the report 12-month results in the first quarter of 2024. We are highly confident in DREAM outcomes based on the over 500 implants in our prior clinical and commercial settings globally, and the DREAM efficacy and safety data released in a late-breaking poster session at Sleep 2023 in June. In the poster, we reported efficacy data on the first 34 DREAM patients reaching 12-month follow-up, which demonstrated a 65% AHI responder rate and a 76% ODI responder rate, and safety data on all patients enrolled in the study, which were in line with our expectations and compared favorable to other neuromodulation studies. As a reminder, for the trial to be successful, of the 115 patients, at least 63% need to be AHI and ODI responders at the 12-month follow-up. The modeler PMA submission continues to progress, with the second module being filed during quarter two. We continue to anticipate submitting the third module later this year and the fourth and final module, which will include 12-month safety and efficacy data shortly after the follow-up period is completed early next year. We remain on track for FDA approval before the end of 2024. The U.S. Access Pivotal Study focused on complete concentric collapse patients continues to enroll, with implants expected to be completed in 2024. As a reminder, CCC patients represent approximately 30% of hyperglossal nerve stimulation eligible to treat OSA patients who are contraindicated to commercially available AGNS therapy in the U.S. and do not have suitable treatment options other than major palate surgery. The excess primary endpoints are similar to the dream study primary endpoints, as Genio has demonstrated similar results in both CCC and non-CCC patients. This already resulted in a label expansion in Europe, where the first commercial triple C patients are being treated. Commercially, this quarter, we reported sales of 1.1 million and increased the number of German centers implanting Genio to 42. This is the result of both strong underlying demand for Genio and commercial investments, including direct-to-consumer online campaigns launched in March. As a result of these DTC efforts, we are seeing approximately 50,000 monthly website visits and nearly 1,700 obstructive sleep apnea patients call the helpline in the second quarter, compared to 292 in the first. Guiding these patients to the appropriate therapy and shortening their time to treatment will contribute to our future success. AGNS in Germany remains highly under-penetrated, with 1.1 million CPAP patients, yet only 620 AGNS implants last year. Identifying CPAP refractory patients is the key to unlocking the market's potential. And we are working closely with sleeve physicians and other industry participants to ensure these OSA patients receive appropriate therapy. We continue to position ourselves as an innovation leader in the OSA space, with always putting patients first and listening to our surgeons. As a result, Genio is a different approach to AGNS than existing implanted battery with leads solutions. Genio offers patients a leadless, full-body MRI-compatible, non-implanted battery solution, powered and controlled by a wearable. Independent patient market research confirmed preference for a system with Genio's features. Thanks to the fully upgradeable wearable component, Genio patients can always have the most advanced technology without needing a new surgery. Next-generation Genio systems will provide patients with real-time feedback through data collection and offer remote monitoring that will improve the patient experience and provide physicians the ability to more efficiently optimize patient care. Concretely, we are currently rolling out Genio 2.1, enabling greater stimulation adjustability, while Genio 3.0 will have a design change integrating patient feedback and positive impact on gross margins by integrating the coil into the wearable component. All this should further increase patient access to AGRS technology. We're also working on regulatory approval to activate existing sensors in the wearable that will adjust stimulation based upon sleeping position. Our European commercialization experience Early dream data and Genio's differentiated design reinforce our confidence in a successful US launch next year. We recently commissioned independent clinician and patient service, which demonstrates significant demand for Genio and supports our view that we can more than replicate our European performance when entering commercially in the US. To ensure we are fully prepared at launch, we have accelerated investments in our U.S. commercial infrastructure. Christophe Eigenman joined as chief commercial officer during the second quarter, and our market access team is making steady progress. We are working closely with the AAO, the American Academy of Auto Laryngology, to define which CPT code would best support Genio at launch. While there are multiple CPT codes being evaluated, they all provide reimbursement that, at the minimum, is in line with current AG&S payment levels. We anticipate having Medicare coverage at launch, with commercial payers following shortly thereafter. Finally, we are making steady progress with our ANSA Certicalis program to our exclusive licensing agreement with the Vanderbilt University. Under the lead of Professor David Kent, in close collaboration with the Nixoa RMD team, we are evaluating stimulation of the antacervicalis nerve to address current AGNF non-responders. The antacervicalis preliminary design work has ended, and we have begun the detailed design phase. We continue to anticipate beginning a feasibility study later this year. In summary, we continue to advance our key objectives for 2023, which are to focus on patient follow-up in the dream study, resulting in reaching the primary endpoints, begin preparations to enter the U.S. market with regulatory, manufacturing, and commercial market access readiness, and drive further revenue growth in Germany while opening new European markets. With that, I'm pleased to turn the call over to our CFO, Louis Moreau, who will provide a financial update.