Nyxoah(NYXH) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q4 2025, gross revenue was EUR 6.3 million before EUR 700,000 of revenue deferrals, resulting in net revenue of EUR 5.6 million, compared to EUR 1.3 million in Q4 2024, indicating significant growth driven by the U.S. commercial launch [14] - Full year 2025 gross revenue was EUR 11 million before EUR 1 million of revenue deferrals, resulting in net revenue of EUR 10 million, a 122% increase from EUR 4.5 million in 2024 [15] - Gross margin for Q4 2025 was 64%, while the full year gross margin was 63% [14][15] - Total operating loss for Q4 2025 was EUR 18.6 million, relatively stable compared to EUR 18.3 million in Q4 2024, while the full year operating loss increased to EUR 83.5 million from EUR 58.8 million in 2024 [14][15] Business Line Data and Key Metrics Changes - The U.S. commercial launch generated approximately EUR 3.5 million of net revenue in Q4 2025, with $4.5 million of revenue generated from the first full quarter of launch [14][5] - 145 surgeons were trained in 125 high-volume hypoglossal nerve stimulation accounts, with 57 receiving positive Value Analysis Committee approval [5][7] - The company reported consistent reimbursement from both commercial payers (approximately 90% of business) and Medicare (10% of business) during Q4 [9][10] Market Data and Key Metrics Changes - The company closed 2025 with a global gross revenue of EUR 11 million, driven by strong momentum from the U.S. launch [6] - Internationally, growth continued in selected markets, including Germany, the United Kingdom, and the Middle East, with Germany being the first international market to reach profitability [12] Company Strategy and Development Direction - The company aims to continue executing its U.S. commercial launch, having increased its sales force to 40 sales reps covering 200 of the top 400 hypoglossal nerve stimulation accounts [17] - The company is expanding its internal manufacturing footprint to strengthen its competitive position and improve gross margins [17] - The company plans to submit a PMA supplement for the ACCCESS study data by the end of July 2026, potentially leading to U.S. label expansion in early 2027 [24][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the U.S. launch momentum and the opportunity ahead, emphasizing the positive feedback from surgeons and patients regarding Genio's unique features [8][12] - The reimbursement environment is viewed as a normal maturation of an established therapy, with clarity on facility fees expected to support further adoption of Genio [11] - The company anticipates a sequential growth of 25% in U.S. net revenue for the first and second quarters of 2026, driven by continued surgeon training and growing adoption [16] Other Important Information - The company reported a cash position of EUR 48 million as of December 31, 2025, with an expected cash burn rate of approximately EUR 20 million per quarter in the near term [15][29] - The introduction of new C-codes for AGNS by CMS is expected to facilitate billing for traditional Medicare patients, aligning reimbursement for Genio with competitors [10][9] Q&A Session Summary Question: Can you provide an update on the remaining VAC processes and new account activations? - Management confirmed that 120 VAC submissions were made, with 57 approved, and expects the remaining approvals to occur in Q1 2026 [20][21] Question: What is the timeline for the ACCCESS study data and PMA supplement submission? - The 12-month data will be available by the end of June 2026, with analysis taking up to 30 days, leading to a PMA supplement submission by the end of July 2026 [23][24] Question: What is the cash burn rate and guidance for 2026? - The cash burn rate is approximately EUR 20 million per quarter, expected to decrease as revenue traction increases in the U.S. [29] Question: How many implants have been performed, and what is the approach to inventory? - Management clarified that they do not disclose precise implant numbers but indicated that revenue generated in Q4 suggests a significant number of implants were performed [33][34] Question: What are the key drivers for Genio adoption among physicians? - Key drivers include the optionality provided by Genio, its single incision technique, and bilateral stimulation, which resonate well with surgeons [50][51]