Q4 2025 Nyxoah SA Earnings Call Transcript
Key Points
- Nyxoah SA (NYXH) received U.S. FDA approval for Genio in August 2025 and successfully launched the product in the U.S. market.
- The company secured reimbursement for Genio across both Medicare and commercial payers, resulting in initial implants and revenue generation as early as September 2025.
- Nyxoah SA (NYXH) trained 145 surgeons in 125 high-volume hypoglossal nerve stimulation accounts, achieving $4.5 million in revenue in Q4 2025.
- The DREAM pivotal study was published, demonstrating Genio's clinical efficacy in both supine and non-supine positions, differentiating it from competitors.
- The company reported a global gross revenue of EUR 11 million for 2025, driven by strong U.S. launch momentum.
- Total operating loss for the full year 2025 was EUR 83.5 million, an increase from EUR 58.8 million in 2024, reflecting the costs of U.S. commercialization activities.
- The cash burn rate is approximately EUR 20 million per quarter, with a cash position of EUR 48 million as of December 31, 2025.
- There is uncertainty regarding the timeline for VAC approvals, which can vary significantly by hospital, potentially affecting the pace of market penetration.
- The introduction of new interim C-codes by CMS for HGNS could impact reimbursement processes, although the company expects no negative impact on Genio adoption.
- Nyxoah SA (NYXH) faces competition from other players in the HGNS market, including potential new entrants like LivaNova, which could affect market share.
Good day, and thank you for standing by. Welcome to the Nyxoah Fourth Quarter Full Year 2025 Earnings Conference Call. [Operator Instructions] Please be advised that today's call is being recorded. I'd now like to hand over to our first speaker today, Pearson 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 Taelman, 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 U.S. 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
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