Nyxoah Reports Fourth Quarter and Full Year 2025 Financial and Operating Results

Core Insights - Nyxoah reported strong financial and operational results for Q4 and full year 2025, highlighting a successful U.S. commercialization launch and positive feedback from surgeons and patients [2][5][9] Financial Performance - Q4 2025 gross revenue reached €6.3 million, with net revenue of €5.6 million, reflecting a 347% year-over-year growth [5][8] - Full year 2025 gross revenue was €11.0 million, resulting in net revenue of €10.0 million, a 122% increase compared to 2024 [9] - The gross margin for Q4 2025 was approximately 64%, while the full year gross margin was around 63% [5][11] Cost Structure - Cost of goods sold for Q4 2025 was €2.0 million, leading to a gross profit of €3.6 million [10] - For the full year, cost of goods sold totaled €3.7 million, with a slight decrease in gross margin from 66% in 2024 to 63% in 2025 due to increased sales volume and operational ramp-up [11] Research and Development - R&D expenses for Q4 2025 were €10.9 million, down from €11.8 million in Q4 2024 [12] - Full year R&D expenses increased to €42.8 million from €34.3 million in 2024, driven by clinical expansion and product development [12] Selling, General and Administrative Expenses - SG&A expenses for Q4 2025 were €12.5 million, compared to €8.1 million in Q4 2024 [13] - For the full year, SG&A expenses rose to €48.3 million from €28.5 million in 2024, reflecting the build-out of the U.S. commercial organization [13] Operating Loss - The operating loss for Q4 2025 was €18.6 million, slightly higher than €18.3 million in Q4 2024 [14] - The total operating loss for the full year was €83.5 million, compared to €58.8 million in 2024, attributed to increased commercialization investments and clinical initiatives [14] Cash Position - As of December 31, 2025, cash, cash equivalents, and financial assets amounted to €48.0 million [15] U.S. Commercialization Strategy - The U.S. commercial launch of the Genio® system began in August 2025, with a focus on high-volume implanting centers and education for referral networks [3][6] - By the end of 2025, 145 surgeons had been trained, and 57 accounts activated in the U.S. [5][6] Future Revenue Guidance - The company anticipates U.S. net revenue for Q1 2026 to grow by approximately 25% over Q4 2025, with similar growth expected for Q2 2026 [24]