Nyxoah SA

Good day, and thank you for standing by. Welcome to the NCSOA First Quarter 2025 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 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 is being recorded. I would now like to hand the conference over to your speaker today, Pearson Dennis, Investor Relations Associate. Please go ahead.

Thank you. Good morning, everyone, and I welcome you to our first quarter of 2025 earnings call. Participating from the company today will be Olivier Talman, Chief Executive Officer, and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our first quarter 2025 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'd 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 forward-looking 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 forward-looking statements. For a list and description of these risks and uncertainties associated with our business, please refer to the risk factors section of our Form 20-F filed with the Securities and Exchange Commission on March 20, 2025. With that, I will now turn the call over to Olivier.

Thank you, Pearson. Good day, everyone, and thank you for joining us for our first quarter 2025 earnings call. Before we start, I'd like to welcome Pearson Dennis, who recently joined us as our investor relations associate. I'd like to focus today's discussion on our path to full P&A approval in the United States. As we announced in March, the FDA issued an approvable letter for GenioSystem, which confirms that our application substantially meets the requirements for marketing in the US. Importantly, the FDA accepted our biocompatibility testing, usability studies, clinical data demonstrating safety and effectiveness of the GenioSystem, just to highlight a few components of our submission. Following receipt of the approvable letter, the FDA will approve the application subject to satisfactory completion of manufacturing facilities, methods and control reviews. In that context, the FDA requested validation of one specific manufacturing process at the US contract manufacturing site. I am pleased to report that our team has successfully completed this validation work and submitted the required documentation to the FDA. FDA reviewed this validation already and has confirmed they have no further questions regarding it. As a final step, the FDA is now conducting an on-site inspection of the US contract manufacturing facility, which we expect to be completed shortly. This site already successfully passed an FDA inspection as part of our PMA process with no deficiencies. We are confident in our ability to complete this final step in the process And based on this timeline, we continue to expect to receive PMA approval in the second quarter of 2025. In preparation of our U.S. commercial launch, we have built a world-class team in support of our U.S. go-to-market strategy. In addition, we have put in place industry-leading talents with a track record in neuromodulation and or obstructive sleep apnea, or OSA, across our sales marketing, reimbursement, and medical affairs teams in the U.S. Our strategy for penetrating the U.S. market is focused on a two-pronged approach. First, as a smart follower, we will target high-volume hyperlossal nerve stimulation implanting centers where patients and physicians are actively seeking an alternative solution to current therapy. Market research confirms significant demand from patients who are hesitant about receiving a pacemaker platform technology, including an implanted battery, which currently requires a subsequent surgery to replace it. Research also indicates that physicians are eagerly awaiting a compelling alternative to further expand their OSA treatment options. This is consistent with feedback from the 75 US physicians that already have been trained on the Genio technology, giving their participation in our clinical trials and usability studies, and became familiar with Genio's unique features and patient outcomes. Second, we will develop strong networks with sleep physicians, who manage large populations of moderate to severe OSA patients, where hyperglossal nerve stimulation is not yet fully embedded as part of their treatment pathway. As a company that prioritizes clinical evidence and patient outcome, oversimplified marketing messages, we believe in setting realistic patient expectations and partnering with physicians to find the optimal treatment for each patient as part of our mission in putting patients first. We are ready to launch in the US with 50 commercial team members who are all hired and trained. This team is comprised of sales, marketing, market access professionals who will be supported by focused direct-to-consumer or DTC initiatives, and dedicated reimbursement support. We plan to scale up U.S. commercial team each quarter post-FDA approval, hand-in-hand with the opening of new and planned accounts. Regarding reimbursement, we are working closely with the American Academy of Autolabangology and participating in the FDA's Early Payer Feedback Program. to educate CMS and major commercial payers on the Genio system and the clinical impact it can have on their OSA patient population. We have identified an 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 indications and is the same CPT code used for the current FDA-approved AG&S technology. We expect that our pricing will be similar to our AG&S competitor while we differentiate ourselves via our unique technology benefits and clinical outcomes. Receiving FDA approval will represent the culmination of rigorous clinical research, technological innovation, and strategic preparation. We look forward to launching Genio in the U.S. upon receipt of FDA approval, bringing a revolutionary OSA solution to patients who have been waiting for an alternative that can truly transform their quality of life and long-term health outcomes. With that, I'll turn the call over to our CFO, John Laundrie, for the financial update.