Nyxoah Reports Second Quarter Financial and Operating Results

Core Insights - Nyxoah has received FDA approval for its Genio system, marking a significant milestone as it becomes the first and only bilateral hypoglossal neurostimulation therapy approved in the U.S. for Obstructive Sleep Apnea (OSA) [4][5][8] - The company has initiated the commercial launch of the Genio system in the U.S., supported by positive data from the DREAM pivotal trial, which demonstrated significant efficacy in reducing apnea-hypopnea index (AHI) [4][6][8] Financial Performance - Revenue for Q2 2025 was €1.34 million, a 74% increase from €0.77 million in Q2 2024 [8][12] - Gross profit for Q2 2025 was €0.85 million, with a gross margin of 63.4%, compared to a gross profit of €0.49 million and a margin of 63.6% in Q2 2024 [7][13] - Operating loss for Q2 2025 was €19.85 million, up from €13.33 million in Q2 2024, primarily due to increased selling, general, and administrative expenses related to the commercialization of the Genio system [7][16][17] Research and Development - R&D expenses for Q2 2025 were €10.06 million, compared to €7.47 million in Q2 2024, reflecting increased R&D activities [14] - Selling, general, and administrative expenses rose to €10.67 million in Q2 2025 from €6.38 million in Q2 2024, driven by costs associated with the commercialization efforts for the Genio system [15] Cash Position - As of June 30, 2025, the company had cash, cash equivalents, and financial assets totaling €43.0 million, down from €63.0 million at the end of Q1 2025 [8][18] Market Position - The Genio system is positioned as a differentiated solution for OSA patients, particularly those underserved by existing therapies, with a focus on providing a leadless and battery-free treatment option [4][22]