Nyxoah Reports First Quarter Financial and Operating Results

Core Insights - Nyxoah is on track for anticipated PMA approval of its Genio® system in the second quarter of 2025, having successfully completed FDA validation requirements and currently undergoing final site inspection [2][4][17] - The company reported a revenue of €1.1 million for Q1 2025, a decrease from €1.2 million in Q1 2024, with a gross profit margin of 61.8% [5][10][11] - Significant increases in research and development expenses (€9.0 million) and selling, general and administrative expenses (€12.4 million) were noted, contributing to an operating loss of €20.6 million for Q1 2025 [12][13][14] Financial Performance - Revenue for Q1 2025 was €1.1 million, down from €1.2 million in Q1 2024 [10] - Cost of goods sold was €406,000, resulting in a gross profit of €658,000 [11] - Research and development expenses rose to €9.0 million from €7.2 million year-over-year [12] - Selling, general and administrative expenses increased to €12.4 million from €6.0 million year-over-year [13] - The operating loss for Q1 2025 was €20.6 million, compared to €12.2 million in Q1 2024 [14] Cash Position - As of March 31, 2025, cash, cash equivalents, and financial assets totaled €63.0 million, down from €85.6 million at the end of 2024 [15] Regulatory Progress - The FDA issued an Approvable Letter for Nyxoah's PMA application for the Genio® system, indicating that the application meets the necessary requirements [6][17] - The final step before full PMA approval is an on-site inspection of the U.S. manufacturing site, which has already passed a previous inspection with no deficiencies [4][18] Company Overview - Nyxoah focuses on developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio® system, a hypoglossal neurostimulation therapy [21] - The company received its European CE Mark for the Genio® system in 2019 and has conducted successful IPOs on Euronext Brussels and NASDAQ [22]