Nyxoah SA

Good day, and thank you for standing by. Welcome to the NCSOA Third Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only 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 11 on your cell phone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's call is being recorded. I would now like to hand the conference over to your first speaker today, Michaela Kirkwood, Investor Relations and Corporate Communications Manager. Please go ahead.

Good afternoon and good evening, everyone, and welcome to our earnings call for the third quarter of 2023. I am Michaela Kirkwood, Investor Relations and Corporate Communications Manager at Nixella. Participating from the company today will be Olivier Tailman, Chief Executive Officer, and Lalique Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our third 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 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 statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factor section on 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. And thank you for joining us for our third quarter 2023 earnings call. During the third quarter, we maintained focus on clinical execution in our open-label US Pivotal Study dream, ensuring a steady course to complete data readout in March 2024. Based upon the dream data published back in June, in combination with commercial patient outcomes in Europe, our confidence is strengthened for a positive dream outcome. In anticipation of our US launch, We have made great progress as we continue to work with the AIO on our interim and long-term coding strategy. Next, we continue to invest in gradually building our leadership in the U.S. commercial organization, including market access to facilitate reimbursement. In Europe, we recently introduced a novel patient-centric approach by initiating a partnership with ResMed Germany. Together, we will strengthen our in-depth understanding of the obstructive sleep apnea patient journey, increasing patient overall OSA awareness, and guiding them from diagnosis to treatment. While CPAP remains the golden standard, there is a large pool of patients not tolerating it and needing therapy due to the severity of their OSA. Through this partnership, we aim to increase epirostal nerve stimulation penetration and accelerate geneal adoption. Now, with that said, Nixoa is entering one of the most exciting times in the company's history. In less than six months, we will report data from our dream US pivotal trial. We recently filed the third module in our modular PMA. and continue to anticipate submitting the fourth and final module, which will include DREAM 12-month safety and efficacy data shortly after the follow-up period is completed. We remain on track for FDA approval before the end of 2024. In anticipation of this, NICSOA continues to expand its U.S. footprint. Current gains on patient follow-up in DREAM. As previously stated, our confidence in DREAM outcomes is supported not only by the roughly 500 commercial and clinical gene globally, but also by 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 months follow-up, which demonstrated a 65% AHI and the 76% ODI responder rate and safety data on all 115 patients enrolled in the study. As a reminder, for the trial to be successful of the 115 patients, at least 62.9% need to be AHI and ODI responders at 12-month follow-up. Next, the USXS 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 hyperlossal 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 complete concentric collapse and non-CCC patients, which resulted in a label expansion in Europe. When entering Germany, Nixoa drove hyperlossal nerve stimulation awareness and therapy penetration, increasing market growth from an estimated 15% to 35% over the last two years. This clearly illustrates the benefit of having multiple hyperglossal nerve stimulation treatment options and having multiple companies on the market. To further our patient-centric approach to treating more OSA patients with the right solution, as I mentioned earlier, we partnered with ResMed Germany. This novel partnership creates an OSA continuum of care that will shorten the time from diagnosis to treatment and ensure patients are not left without an appropriate therapy. As an example, there are approximately 1.1 million CPAP patients in Germany, of which up to 35% fail within three years. This collaboration should increase the number of patients in Germany receiving and staying under OSA therapy. Concretely, to increase patient awareness, we will collaborate through OSA helplines and DTC marketing initiatives. We will run joint Salesforce efforts towards ENT surgeons, sleep physicians, and dentists, as well as educational programs. Both companies will work closely with scientific societies to further optimize patient care guidelines. In conclusion, this initiative exemplifies our mission to make sleep simple again. Commercially, this quarter, we reported sales of 1 million euro and increased the number of German centers implanting Genio to 46. Our direct-to-consumer campaigns, started in the second quarter this year, resulted in a strong website traffic with approximately 55,000 monthly website visits. We are anticipating the first results from these initiatives already in Q4 later this year, with strong year-over-year implant growth. We continue to position ourselves as an innovation leader in the OSA space with always putting patients at the center and listening to our surgeons. As a result, Genio is a different approach to AGNS compared to the existing implanted battery with leads solution technology. Genio offers patients a leadless full-body 1.5 Tesla and 3 Tesla MRI compatibility, non-implanted battery solution. powered and controlled by a wearable. Our vision of an implant for life concept powered and controlled by a wearable component allows patients to always have the most advanced technology without the need for another surgery. Independent patient market research confirmed preference for a system with Genio features and form factor. The recently launched Genio 2.1 wearable enables greater stimulation adjustability and gives patients the autonomy to adjust stimulation amplitude within predefined boundaries, while the Genio 3.1 implantable stimulator is under regulatory review and will further report or implant for life concept. We are also working on regulatory approval to activate existing sensors in the wearable component that will adjust stimulation based upon sleeping position. Future generations of the GENIUS system 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 optimize patient care more efficiently. All this should further increase patient access to epiglossal nerve stimulation technology and have a positive impact on the company's gross margin. Our European commercialization experience Early dream data and Genio's differentiated design reinforce our confidence in a successful US launch. We commissioned independent clinician and patient surveys which demonstrate significant demand for Genio and support 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 continue to invest in our U.S. commercial infrastructure and securing reimbursement. Last month, an advisory panel for the ENT Scientific Society discussed the CPT code that would best support Genio. While this is not the outcome of the meeting, we expect reimbursement to be at the minimum in line with the current AGNS payment rates in the U.S. Finally, we are making steady progress with our Antacervicalis program through our exclusive licensing agreement with Vanderbilt University. Under the lead of Professor David Kent in close collaboration with the Nixoa R&D team, we are evaluating stimulation of the Antacervicalis nerve to address current AGNS non-responders. We have entered the detailed design phase and anticipate beginning of feasibility study shortly. 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 US market with regulatory, manufacturing, commercial, and market access readiness, and drive further revenue growth in Germany while opening new European markets. To that end, we implanted our first patients in Italy. With that, I'm pleased to turn the call over to our CFO, Loïc Moreau, who will provide a financial update.