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]

Core Viewpoint - Inspire Medical Systems has lowered its full-year revenue forecast for 2025, expecting sales to be between $900 million and $910 million, down from a previous estimate of $940 million to $955 million, with adjusted EPS projected between $0.40 and $0.50, significantly lower than the earlier forecast of $2.20 to $2.30 [2][3] Financial Performance - In Q2 2025, Inspire reported revenue of $217.1 million, a year-on-year increase of 10.8%, exceeding analyst expectations of $214.3 million. However, the company recorded a net loss of $3.6 million, a decline from a net profit of $9.8 million in the same period of 2024, primarily due to increased operating expenses and one-time costs [4] - Operating expenses for the quarter reached $185.7 million, a 15% increase year-on-year, while the gross margin was 84.0%, slightly down by 0.8 percentage points compared to the previous year [4] Inventory and Product Transition - As of June 30, the company's inventory stood at $121.6 million, up from $80.1 million at the end of the previous year, indicating transitional inventory pressure between Inspire IV and Inspire V [5] Product Development - Inspire Medical's core product, the Inspire neurostimulation system, is designed for treating moderate to severe obstructive sleep apnea (OSA) patients who cannot tolerate CPAP therapy. The system includes components that stimulate the hypoglossal nerve to prevent airway collapse during sleep [6][8] - Inspire V, the latest iteration of the product, received FDA approval in 2024 and has been launched in the U.S. However, market conversion has been slower than expected, impacting the company's financial performance [12] Legal and Competitive Challenges - The company incurred $1.7 million in legal expenses during the quarter, partly related to a civil investigation by the U.S. Department of Justice and a patent infringement lawsuit against competitor Nyxoah [13] - Inspire Medical emphasizes that these legal costs are temporary and do not reflect core operational performance. The company plans to enhance clinical data accumulation and improve market education to boost commercialization [15] Company Overview - Inspire Medical Systems, based in Minneapolis, Minnesota, focuses on OSA treatment and is the first company to achieve non-CPAP treatment through neurostimulation. Since product approval, over 100,000 patients have been treated globally [16] - The company has established over 1,435 implantation centers and 335 sales territories in the U.S. and has received regulatory approvals in Europe, Japan, and other regions. In 2024, the company reported annual revenue of $803 million, with a compound annual growth rate exceeding 60% [16] - Despite a slowdown in growth for 2025, the company remains focused on product conversion efficiency, international market expansion, and physician education to drive the penetration of Inspire V [16][17]