Nyxoah SA

Hello, and welcome to NXIV Fourth Quarter 2024 Earnings Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the 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. I would now like to turn the conference over to John Landry. You may begin.

Thank you. Good morning, everyone. And I welcome you to our earnings call for the fourth quarter and full year 2024. Participating from the company today will be Olivier Talman, Chief Executive Officer, and myself, John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our fourth quarter and full year 2024 financial results released before U.S. market opening 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 on 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 factors section of our form 20F filed with the Securities and Exchange Commission on March 13th, 2025. With that, I will now turn the call over to Olivier. Thank you, John.

Good day, everyone, and thank you for joining us for our fourth quarter and full year 2024 earnings call. 2024 was a transformative year for Nixola. With tremendous progress made throughout the year, we are extremely well positioned to bring Genio to market in the U.S. by the end of this month. We have proven that Genio can deliver best-in-class outcomes for obstructive sleep apnea patients. Our pivotal study, DREAM, met both its primary and secondary endpoints. The DREAM study demonstrated a strong AHI responder rate of 63.5%, and an ODI responder rate of 71.3%, with an overall median AHI reduction of 70.8%. Importantly, through the study, we demonstrated that Genio is the only therapy with explicit clinical evidence-based data proving its ability to maintain its efficacy irrespective of a patient's sleeping position. This is a critical differentiator as people sleep on average between 35 to 40% of the night on their back. And based on published data, the number of times per hour that a patient stops bleeding can double while in a supine position. Genio stands alone with clinical trial data specifically validating this claim, making it the most consistently effective solution for patients throughout the entire night of their sleep. While our dream study uniquely required the minimum of 60 minutes of supine sleep time, on average, all subjects slept 114 minutes in a supine position. The study measured position-specific outcomes and demonstrated a 66.6% median AHI reduction while sleeping in a supine position. despite the fact that the number of airway obstructions can double in this position. This reduction compares favorably to the 71% median reduction shown while sleeping in a non-supine position. And this consistent efficacy across sleep positions make Genio the most effective solution for patients throughout the entire night of sleep. unlike competing technologies where supine sleep efficacy data have not been disclosed. Additionally, on-dream data revealed another significant clinical advantage. Genio produces a remarkable percentage of what we refer to as super-responders, patients whose AHI scores is dropping below 15. effectively returning their mortality and cardiovascular risk to levels comparable to individuals not suffering from OSA. 82% of all DREAM subjects achieved this result. This represents a profound clinical impact that goes beyond symptom management to potentially extending patient lives. The combination of the supine and super-responder data makes Genio a differentiated and unique solution for patients with OSA. In addition to these strong efficacy results, Genio also demonstrated a favorable safety profile with an 8.7% severe adverse event rate. We believe that this efficacy and safety profile will have a positive impact on therapy selection by physicians and therapy acceptance by patients compared to the current available AGNS solution. Let me now switch to the regulatory perspective. We have submitted the fourth and final module of our PMA submission in June 24th. We continue to have a very interactive dialogue with the FDA and have successfully completed the remaining requirements, including this Belgium site visit, which has previously been delayed due to circumstances unrelated to NYXOA. Based on our current interactions with FDA, where the focus is now on labeling, we continue to expect to receive FDA approval by the end of March of 2025. In preparation for our U.S. commercial launch, we have built a world-class team in support of our U.S. go-to-market strategy and commercial readiness plan. Notably, I moved with the family to the U.S. to be on the ground during this critical period. In addition, we have built our U.S.-based senior management team, including hiring John Landria's chief financial officer, Dr. Moritz Boone as Chief Medical Officer, and Scott Holstein as Chief Commercial Officer. In addition, we have industry-leading talent in place with a track record in OSA and our neuromodulation across our sales, marketing, reimbursement, and medical affairs teams in the US. Our strategy for penetrating the US market revolves around two-pronged approaches. First, as a smart follower, we will target high-volume AGNS implanting centers where physicians and patients are actively seeking an alternative solution to current therapy. In addition to these patients, we have also identified significant demands from patients who are hesitant about receiving a pacemaker like Implant4OSA. and whose physicians have been eagerly awaiting a compelling alternative to offer them. Importantly, as a result of our clinical trials in the US, there are already 75 physicians that have been trained on the Genio technology and are familiar with its unique features and patient outcomes. Second, through focused commercial investments, we will develop strong referral networks with sleep physicians who manage a large population of moderate to severe OSA patients where AGNS is not yet fully embedded in their treatment pathway. As a company that prioritizes clinical evidence and patient outcomes over simplified marketing messages, we believe in setting realistic expectations and partnering with physicians to find the optimal treatment for each patient. as this is part of our mission in putting the patients first. We plan to launch in the US with 50 commercial team members, comprising sales, marketing, and market access professionals, who are currently all hired and trained, with plans to scale quarter after quarter. This team will be supported by focused direct-to-consumer initiatives and dedicated reimbursement support. Regarding reimbursement, we have identified and established CPT code that we plan to utilize at launch. The CPT code, to be very precise, is 64568. This CPT code has been recognized by commercial and government payers for OSA indication and is the same CPT code used for the current FDA-approved AG&S technology. We expect this will allow us to align on pricing while we will be differentiating on our unique technology and clinical outcomes. We are working closely with the American Academy of Otolaryngology and participating in the FDA's early payer feedback program to educate CMS and major commercial payers on Genio on the impact it can have on their patients. While our primary focus as a company has been on preparing for a US launch, we also continue to be encouraged by our growth and what we learned in Europe. Our commercial proof of concept in Germany has provided valuable insights that we are actively incorporating into our US launch strategy. Our growth in Europe was primarily driven by the continued execution of our commercial strategy in Germany. As John will detail in his remarks, we are now recording a portion of our disposable patch revenue as deferred revenue. Our revenue would have been 1.9 million in the fourth quarter of 24, excluding the impact of this deferral. This represents a 46% sequential growth over Q3 2024. For the full year, we have delivered revenue of 5.1 million euros, and an 18% increase over 2023. We have also continued to expand our geographic footprint in the region. In December, we launched Genio in the United Kingdom. The Genio system is covered under the NHS Specialised Service Device Programme, which makes us believe that the UK has the potential to become one of our largest international markets. Based on the first successful implant at University College London's hospital, there was a lot of excitement created for Genio in the UK. We look forward to further expanding into other hospitals across the country and scaling our sales force. In addition, we have launched in the United Arab Emirates with the first commercial implant done in Dubai's German Saudi hospital. This represents a unique milestone as Genio was the first AGNS implant performed in the Middle East. Collectively, all of our accomplishments in 2024 brought us at this point. We are now on the verge of bringing a truly innovative OSA solution to the U.S. market where there still exists a massive patient population in need of treatment that can benefit from our Genio solution. Both we and the clinical community are incredibly excited about what the rest of 2025 has in store. With that, I'll turn the call over to our CFO, John Landry, for a financial update.