Nyxoah SA

conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, we'll open up for questions. To ask a question during a 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 again. Please be advised that today's call is being recorded. I want to hand it over to our first speaker today, Peterson Dennis, Investor Relations Associate. Please go ahead.

Thank you. Good afternoon, everyone, and I welcome you to our fourth quarter and full year 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 fourth quarter 2025 financial results released after US market closing 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 the risks and uncertainties associated with our business, please refer to the risk factors section of our Form 20F, which will be filed with the Securities and Exchange Commission. 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 fourth quarter and full year 2025 earnings call. Let me start by our 25 key milestones and highlights. 25 was a transformative year for Nixoa. We achieved several defining milestones during the year. In early 2025, in anticipation of FDA approval, we hired and trained our U.S. commercial team. including our first 25 stale traps. We developed our strategic launch plan, worked on securing market access, and mapped out target accounts focused on the top 400 highest-volume hypoglossal nerve stimulation accounts around the US. On August 8, we received US FDA approval for Genio, followed by actively launching our product. We secured reimbursements for Genio across both Medicare and commercial payers, resulting already in first implants and revenue as early as September 2025. We successfully executed on our focused launch in the United States. We trained 145 surgeons in 125 high-volume hipoglossal nerve stimulation accounts, of which 57 already received positive Value Analysis Committee approval, resulting in $4.5 million of revenue generated in Q4. This translates into $720,000 in annualized sales rep productivity during the first full quarter of launch. From a clinical data perspective, the DREAM Pivotal study was published in the Journal of Clinical Sleep Medicine These data demonstrated genius clinical efficacy in both supine and non-supine positions as reflected in our labeling and differentiating us from competition. Internationally, we continued driving growth in selected markets, including Germany, United Kingdom and the Middle East. We closed 2025 with a global gross revenue of 11 million euros driven by strong Q4 US launch momentum. Now let me dig in deeper, starting with our commercial update. The fourth quarter marked our first full quarter of US commercialization following FDA approval, and we are excited with the first launch results. Let me share with you the key leading indicators that we are tracking to. As of December 31, 2025, With our 25 sales reps, we focused on 125 out of the 400 top AGNS accounts in the US. From these accounts, 145 surgeons were trained. We completed 120 Value Analysis Committee submissions and received 57 approvals already, with no VAC rejections to date. US reimbursement has been consistent for Medicare and many large commercial payers to date. For the past months, I've had the chance to meet multiple surgeons and sleep customers across the U.S., hearing consistent positive feedback on Genio's unique approach and the optionality we now offer to patients and physicians. Surgeons are attracted by the bilateral stimulation, the single incision procedure, and the consistent therapy efficacy across all sleeping positions, which makes Genio unique on the market. In their interactions with patients, they highlight the patient-centric design, including the battery-free implantable, full-body MRI compatibility, and no need for resurgery due to battery depletion or software upgrades. In addition, sleep physicians note that the first wave of activated patients in the US are providing strong positive feedback on therapy outcomes. From a reimbursement perspective, ahead of FDA approval, we worked to align Genio coverage with the broad framework of hypoglossal nerve stimulation therapies across both commercial payers and Medicare. I'm pleased to report that Genio has been consistently reimbursed by both commercial payers, which represents approximately 90% of our business, and Medicare, which represents the remaining 10% of the Genio business during Q4. Recently, there has been a lot of discussion and communication regarding AG&S reimbursement overall. As is typical for a relatively new product category, in combination with an expanding landscape where Genio enters the market, procedural coding practices continue to mature. In February 2026, CMS established new interim C codes for AG&S that facilities will use when billing for traditional Medicare patients, including specific codes 8011, 12 and 13, which apply to external power devices including of Genio system. Last Friday, CMS indicated that the new C code 8011 used for a Genio implant would be reimbursed in the hospital outpatient department at $31,526. in line with 2026 coverage for CPT code 64582. This also means that there is no reimbursement difference between the GENIUS system and competition. Staying with Medicare, the introduction of C codes does not change how surgeons bill their physician fee for Medicare procedures. Surgeons are responsible for selecting the appropriate CPT code and potential modifier use. Given recent CMS guidance, we expect surgeons will elect to use CPT645A2 for their physician fee. Let us turn now to commercial payers, which represent approximately 90% of all business. Claims continue to be processed under CPT code 645A2, or 64568, depending on payer policy, contractual terms, documentation and individual case review. To date, we have seen strong prior authorization outcomes across cases submitted to commercial payers, including many of the largest in the United States. In conclusion, we view the current reimbursement environment as a normal maturation of an established therapy. With the recent clarity on the facility fee of $31,526 for the Genio C code, we are confident that it will not have any negative impact on further Genio adoption in going forward. We remain actively engaged with specialty societies and coding authorities to support long-term dedicated AGNF CPT codes. From an international update perspective, while the U.S. is the primary growth driver, international markets continue to provide a consistent revenue contribution. Our goal is to ensure each of our international markets are profitable, with Germany being the first that has reached this goal. In summary, entering the US market in 2025, which is the largest AGMF market in the world, completes our transition into a commercial organization. The momentum we see in the U.S. launch reinforces our confidence in the opportunity ahead. With that, I will now turn the call over to John for a detailed overview of our financial results.