Nyxoah SA

Thank you for standing by, and welcome to NSOA's first quarter 2023 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentations, there will be a question-and-answer session. To ask a question at that time, please press star 11 on your telephone. As a reminder, today's call is being recorded. I will now turn the conference to our host, Ms. Michaela Kirkwood, Corporate Communication and Investor Relations Manager. Please go ahead.

Good afternoon and good evening, everyone, and welcome to our earnings call for the first quarter of 2023. I am Michaela Kirkwood, Corporate Communication and Investor Relations Manager at Nexcella. Participating from the company today will be Olivier Tellman, Chief Executive Officer, and Loic Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our first 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 events 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 do not require actual results or events to material differ for 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 and description of these risks and uncertainties associated with our business, please refer to the risk factor section of our form 20F file with the Securities and Exchange Commission on May 16th, 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 our first quarter 2023 earning call. 2023 will be an important year for NYXOA with DREAM patient follow-up and further PMA module submissions. We completed all 115 implants in our US Pivotal Study DREAM in the first quarter, and the clock is sticking to 12-month data in the first quarter of 2024. We are highly confident in DREAM outcomes based not only on our prior clinical and commercial experience, but also on the data released on the first 34 patients in the DREAM study. These 34 patients demonstrated a 65% AHI responder rate, a 76 ODI responder rate, and safety in line with expectations. 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. These abstract data will be presented at SLEAP 2023 on June 6 in a late-breaker poster session. The modular PMA submission was kicked off, with the first module having been submitted during the first quarter. We anticipate filing three out of the four modules in 2023. The final fourth module, which will include 12-month safety and efficacy data, will be submitted shortly after the follow-up period is complete. Our increasing conviction in Dream Outcomes and the market opportunity for Genio has driven our decision to accelerate preparations to enter the US market. To that end, I am very pleased to announce that Christophe Eigenman has joined Nixoa as Chief Commercial Officer. Christophe brings a wealth of medical device experience to Nixoa having spent over 20 years at Johnson & Johnson, leading orthopedic and neuro businesses in the U.S. and other global geographies. Christophe and his family are based in the U.S., and his priority will be preparing the U.S. commercialization strategy and driving international sales growth and further market access. The U.S. access pivotal study focused on complete concentric collapse patients is well underway with implants expected to be completed in 2024. As a reminder, CCC patients represent approximately 30% of AGNS eligible to treat OSA patients who are contraindicated to our commercially available hippoglossal nerve stimulation therapy in the US 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. Commercially, we reported European sales of €441,000 during the quarter, which was below expectations. However, after an in-depth review, we see the quarter was impacted by several transitory factors. Our highest volume accounts saw a seasonal reduction in OR capacity. Second, several newly activated accounts were slower to implant due to the administrative burden necessary to clear procedure funding. Lastly, doctor availability was limited during the quarter, and therefore several new accounts had to postpone procedures. The German team managed to resolve these challenges resulting in sales thus far in the second quarter exceeding first quarter revenue. Finally, we reported our first implant in Austria during the quarter. We continue to achieve becoming an innovation leader in the obstructive sleep apnea space. Clinicians have embraced the genial technology driven by a single incision, leadless system offering bilateral stimulation, powered by an external battery and full-body MRI compatibility. For patients, Genio's ability to upgrade to the latest technology without the need for another surgical intervention is strongly resonating. This is demonstrated with our recent approval of the Genio 2.1, which improves patients' comfort and compliance without the need for a surgical procedure to replace the implantable components. Finally, we anticipate the antacervicalis feasibility study to begin this year, which will explore the stimulation of the antacervicalis nerve in patients who are hyperlossal nerve stimulation non-responders. We are making strong progress towards our key objectives for 2023, which are to focus on patient follow-up in the DREAM study, resulting in reaching the primary endpoint. We begin preparations to enter the US market with regulatory manufacturing and 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, Loïc Moreau, who will provide a financial update.