Nyxoah SA

Ladies and gentlemen, thank you for standing by. Welcome to NXO first quarter 2024 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 would need to press star 11 on your telephone. 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 conference call is being recorded. I would like now to turn the conference over to Michaela Kirkwood, Investor Relations and Communications Manager. Please go ahead.

Good afternoon and good evening, everyone, and welcome to our earnings call for the first quarter of 2024. I am Michaela Kirkwood, Investor Relations and Communications Manager at NXOA. Participating from the company today will be Olivier Tillman, Chief Executive Officer, and Lalique Morel, Chief Financial Officer. During the call, we will discuss our operating activities and review our first quarter of financial results released after U.S. markets 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 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 lessened description of the risks and uncertainties associated with their business, please refer to the risk factors section of our Form 20-F filed with the Securities and Exchange Commission on March 20, 2024. 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 2024 turnings call. 2024 has been transformational for Nixoa. In March we announced our dream US pivotal study achieved its primary endpoints and demonstrated that Genio has the potential for best in class outcomes for OSA patients. I would like to congratulate our clinical team on these terrific results. Our regulatory team is working diligently to file the fourth and final module in our Modular PMA Submission Disc Order, which will set the stage for entering the US market upon FDA approval as early as the end of 2024. Additionally, Dr. Moritz Boon, one of the pioneers in hypoglossal nerve stimulation, joined us from Thomas Jefferson University as chief medical officer, and we announced a partnership with the American Association of Otolaryngology at the Neck Surgery Foundation to drive Medicare and commercial payer coverage. Commercially, we reported first quarter sales of 1.2 million euros almost tripling revenue from the first quarter of 2023 and benefiting from our focused approach on strengthening collaboration between implant surgeons and referring sleep physicians. To recap DREAM, the study had co-primary endpoints of AHI responder rate per the shared criteria at 12 months and ODI responder rate at 12 months. At baseline, subjects had a mean AHI of 28.0, ODI of 27.0, and a body mass index of 28.5. On an intent to treat or ITT basis, DREAM study showed an AHI responder rate of 63.5% with a p-value of 0.002. and an ODI respond rate of 71.3%, with a p-value less than 0.001. With these strong results, the DREAM study met its primary endpoints. Additionally, subjects demonstrated a median 12-month AHI reduction of 70.8%. with similar AHA improvements in supine and non-supine sleeping positions. The safety results were favorable, with 11 serious adverse events, or SAEs, in 10 subjects, resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device-related, and there were three explants. The DREAM results further differentiate Genio as it was the first AGNS study to require patients to sleep at least 60 minutes in the supine position and demonstrated strong efficacy with patients sleeping supine and non-supine. This is of particular importance since published data show increased OSA severity in the supine position, with AHI doubling in the supine versus the lateral position. On average, people sleep 35 to 40% in a supine position during a standard night, which was in line with our PSG findings in DREAM. This means that irrespective of a patient's sleeping position, Genio maintains its efficacy. Based on early feedback from the physicians, this can be very impactful on therapy selection. It supports our mission to make sleep simple again, and we intend to apply for the inclusion of supine efficacy results in our label. With the positive DREAM results, we are now finalizing our modular PMA submission. We have responded to the FDA questions on the first three modules and are in an interactive review and anticipate filing the fourth and final module this quarter. We are preparing for a launch by the end of 2024. as based upon modeler PMA review cycle times. We anticipate FDA approval in late 24th or early 25th as we do not control FDA timelines. In parallel, we continue making progress on the reimbursement side as we are establishing reimbursement pathways with commercial payers, Medicare and Medicaid. The reimbursement team is working closely with the AAO and reimbursement experts to secure coverage at FDA approval. Ahead of approval, we will be conducting a payer feedback interview with the former CMS and Commercial Plan Medical Director, as well as participate in the early payer feedback program for the FDA, designed to provide direct feedback from major payers such as UnitedHealthcare, Blue Cross Blue Shield, Aetna, as well as CMS. Upon commercialization, we will have a prior authorization team in place to assist with claims submission and payment. Our U.S. focus is significantly increasing, highlighted by the recent addition of Dr. Mo Boon as Chief Medical Officer. Dr. Boon, who joined NCSOA from Thomas Jefferson University, is internationally recognized as one of the most experienced surgeons in the field of OSA and AGLS. Being able to have such high caliber talent joining Nixola is a strong validation of the opportunity for Genio to disrupt the OSA market. We are actively building our U.S. commercialization team to be ready to launch by the end of this year. The current AGNS market in the US is very concentrated, allowing for a laser-focused launch, breaking the current monopoly with EMT sites, while establishing a patient referral pathway from sleep specialists. As part of FDA approval process, we ran a usability study with 31 physicians that are the top AGNS implanters in the US. and their feedback was overwhelmingly positive. Providing a little more color on the usability study, naive surgeons, meaning surgeons without experience with Genio, were invited to participate in a training session on how to safely use the device. The training contained theoretical sessions, followed by both animal and cadaver implants. Twelve hours later, Mimicking a real OR setting, surgeons had to repeat the implant without guidance to demonstrate they properly retained the knowledge on device programming and acquired the implantation technique, always ensuring patient safety and comfort during the procedure. These surgeons were adamant they want to be the first genuine implanters in their areas and convinced of the differentiation of Genio versus current AGNS technology in terms of invasiveness, patient-centricity, safety, and the simplicity to treat OSA patients regardless of their sleeping position. In addition, a recent independent survey demonstrated that over 20% of US AGNS candidates are declining a pacemaker based platform technology due to their concerns over the invasiveness and having implantable battery in the chest going back to europe first quarter sales was 1.2 million euros an increase of 177 percent of the first quarter of 2023 as part of our commercialization of commercial proof of concept in germany we see that first the majority of accounts became mixed implanting accounts embracing Genio in their practice. Second, therapy penetration is strongly accelerating as a result of Genio entering the market as a new player. And third, there is a large pool of CPAP quitting patients in need for treatment, which can be addressed through establishing a strong collaboration between implanting surgeons and referral sleep physicians, highlighted by our ResMed collaboration. In summary, we started 2024 strongly by reporting positive dream data, further differentiating Genio with our unique supine list. For the remainder of the year, we are working towards FDA approval by the end of the year and commercial readiness for a strong US launch in 2025. With that, I'm pleased to turn the call over to our CFO, Louis Moreau, who will provide a financial update.