Nyxoah SA

Thank you for standing by and welcome to the NXOA fourth quarter 2022 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentations, there'll be a question and answer session. To ask a question at that time, please press star one one on your telephone. As a reminder, today's call is being recorded. I will now turn to conference studio host, Michaela Kirkwood, strategy and investor relations manager. Please go ahead.

Good afternoon and good evening, everyone, and welcome to our earnings call for the fourth quarter of 2022. I am Michaela Kirkwood, Strategy and Investor Relations Manager at Nixella. Participating from the company today will be Olivier Talman, Chief Executive Officer, and Malik Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our fourth 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 section of our 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 looking forward statements. All SOAR 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 materially 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 the risks and uncertainties associated with our business, These refer to the risk factor section of our Form 20F filed with 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. Thank you for joining us for our fourth quarter 2022 earning call. I am extremely excited to announce we have implanted all 115 patients in our US Pivotal Study DREAM and filed the first module in our Modular PMA submission. With the clock now ticking to our 12-month data, our focus shifts to strong patient follow-up. What pleases me even more is to see the first 34 DREAM patients completing 12-month follow-up showing a 65% AHI responder rate and a 76 ODI responder rate and safety in line with our expectations. This is supporting what we have already demonstrated in studies and European commercial patients. We have submitted this data as a late-breaking abstract to the SLEEP 2023 conference in June. While these data are preliminary and not conclusive of final dream success, they are highly encouraging. Commercially, our European sales and marketing organization continued its strong execution with sales of 1.3 million euros in the quarter. In Germany, we are exiting the year with roughly 34% market share and with 38 active accounts, up from 12 at the end of 2021. Finally, we continue to expand our commercial presence in Europe as we expect to record our initial sales in Austria during the first quarter. As a reminder, 2022 was the first full year of reimbursement in Germany and I'm extremely proud to see how leading German clinicians have embraced the Genio technology. driven by a single incision, a leadless system offering bilateral stimulation powered by an external battery and a full-body MRI compatibility. While it's strongly resonating with patients is the ability for Genio to always be upgraded to the latest technology without the need for another surgical intervention. We received clearance for our Belgium manufacturing facility adding a second manufacturing site and thereby strengthening our supply chain. This is an important milestone in securing capacity to meet growing demand in Europe ahead of our US launch. As for excess study for complete concentric collapse patients, we have implanted the first patients. CCC patients, once refractory to CPAP, have currently no hypoglossal nerve stimulation treatment options in the US. These patients represent roughly 30% of the moderate to severe OSA population. With a CCC label in the US, we would remove the important hurdle of a drug-induced lipendoscopy, so patients will have simpler and faster access to our hypoglossal nerve stimulation therapy. From an R&D perspective, we continue to innovate. Last year, we received regulatory approval for Genio 2.1. And we made further progress on the ANSA Cervicalis project in collaboration with Transbuilt University. We anticipate initiating a feasibility study in 2023. Now I would like to share our three key objectives for 2023. First is to focus on patient follow-up in the DREAM study, resulting in reaching the primary endpoints. Next is beginning preparations to enter the U.S. market with regulatory manufacturing and market access readiness. And last, it's driving further revenue growth in Germany and opening new European markets. Before I turn the call over to our CFO, Louis Moreau, I would like to invite all those on the call to join us for our first investor and analyst meeting tomorrow, March 23rd, in New York, beginning at 4 p.m. Eastern Time. Registration details can be found on our investor relations website. Louis.