Nyxoah(NYXH) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q4 2025, gross revenue was EUR 6.3 million before revenue deferrals of EUR 700,000, 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 [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 in 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] Market Data and Key Metrics Changes - The company secured reimbursement for Genio across both Medicare and commercial payers, with Medicare representing 10% of the business and commercial payers approximately 90% [9][10] - The introduction of new C-codes for hypoglossal nerve stimulation by CMS is expected to facilitate billing and reimbursement processes [10] 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] - Plans for 2026 include expanding internal manufacturing to strengthen competitive position and improve gross margins [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the U.S. launch momentum and the opportunity ahead, with expectations for U.S. net revenue to grow 25% sequentially in Q1 and Q2 2026 [16] - The company anticipates a strong financial profile as it gains market share in the U.S. [17] Other Important Information - The DREAM pivotal study published in the Journal of Clinical Sleep Medicine demonstrated Genio's clinical efficacy, differentiating it from competitors [6] - The company closed 2025 with a global gross revenue of EUR 11 million, driven by strong Q4 U.S. launch momentum [6] Q&A Session Summary Question: Update on VAC submissions and account activations - Management confirmed 120 VAC submissions with 57 approvals, expecting more approvals in Q1 2026 [21][22] Question: Timing for ACCESS study data and PMA supplement submission - The 12-month data will be available by the end of June 2026, with submission planned for Q1 2027 [24] Question: Cash burn rate and guidance for 2026 - Cash burn is approximately EUR 20 million per quarter, expected to decrease as revenue traction increases [29] Question: Competitor's coding strategy and implant numbers - Management indicated plans to pursue dedicated coding for Genio by 2028, while not disclosing specific implant numbers [31][33] Question: Key drivers for Genio adoption among physicians - Surgeons are attracted to Genio's unique features, including bilateral stimulation and a single incision procedure [51]