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]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was €1.1 million, a decrease from €1.2 million in Q1 2024, attributed to temporary softness in the international HD and S market and a phased launch of the Genio 2.1 patient software upgrade [15][16] - Total operating loss for Q1 2025 was €20.6 million, compared to €12.2 million in Q1 2024, driven by investments in the U.S. commercial organization in preparation for FDA approval and launch [16] - Cash position as of March 31, 2025, was €63 million, down from €85.6 million at the end of 2024 [16] Business Line Data and Key Metrics Changes - The company launched the Genio 2.1 patient software upgrade, which led to some sites deferring purchases until the upgrade was available [15] - The U.S. market strategy includes targeting high-volume hypoglossal nerve stimulation implanting centers and developing networks with sleep physicians [10][11] Market Data and Key Metrics Changes - The company is preparing for a U.S. commercial launch, with a focus on addressing the needs of patients and physicians seeking alternatives to current therapies for obstructive sleep apnea (OSA) [10][11] - Market research indicates significant demand for alternatives to existing pacemaker technologies among patients and physicians [10] Company Strategy and Development Direction - The company aims to achieve full PMA approval in the U.S. by Q2 2025, with a focus on building a world-class team for the U.S. go-to-market strategy [6][8] - The strategy includes a two-pronged approach: targeting high-volume centers and developing strong networks with sleep physicians [10][11] - The company emphasizes a patient-first approach and aims to differentiate itself through unique technology benefits and clinical outcomes [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving FDA approval and highlighted the enthusiasm from the clinical community regarding the innovative OSA treatment options [19][20] - The company believes it is positioned for significant growth following FDA approval, with a well-prepared commercial team and established reimbursement pathways [19][20] Other Important Information - The company has identified an established CPT code (64568) for reimbursement, which is recognized by commercial and government payers for OSA indications [13] - The company is actively working with the American Academy of Otolaryngology and participating in the FDA's early payer feedback program to educate payers on the GENEOS system [12] Q&A Session Summary Question: What needs to be done at the U.S. inspection? - The FDA requested validation of a specific manufacturing process at the contract manufacturer, which is currently ongoing [22][25] Question: Can you clarify the physical site inspection status? - The site inspection is actively taking place and can last up to five days, after which a report will be submitted to the FDA [25][26] Question: What is the company's strategy for outreach to ENT and sleep doctors? - The company plans to highlight clinical data showing effectiveness in supine sleep position and positional OSA to differentiate its product [30][32] Question: Is there a statutory response time from the FDA for approval? - After the inspection, a final report will be submitted to the FDA PMA review committee, which will then issue an approval [36][38] Question: Any updates on the Dream Journal publication? - The publication is in the second level of review, and the company expects it to be published before summer [40] Question: What is the expected pace of OpEx spending going forward? - The company plans to defer costs and investments until FDA approval is achieved, extending the cash runway into Q2 2026 [42][44] Question: How is the commercial launch of GENEOS in Dubai progressing? - The company has successfully implanted GENEOS in Dubai and is expanding to other locations in the Middle East [48][49] Question: What is the status of the ACCESS study? - The company is making progress in enrolling patients for the ACCESS study, with a timeline to stop enrollment by summer [50][51] Question: Will the initial FDA approval have a contraindication for CCC patients? - The company does not expect CCC to be a contraindication but rather an off-label indication, allowing physician discretion [80][82]