Core Viewpoint - Nyxoah SA will release its financial results for the fourth quarter and full year of 2025 on March 19, 2026, and will host a conference call to discuss these results [1]. Company Overview - Nyxoah is a medical technology company focused on developing innovative solutions for Obstructive Sleep Apnea (OSA) through neuromodulation [4]. - The company's lead product is the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy for OSA, a condition linked to increased mortality risk and cardiovascular issues [4]. Recent Developments - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5]. - Nyxoah has completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021 [5]. - The company received CE mark approval for expanding therapeutic indications to Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study [5]. - Nyxoah announced positive results from the DREAM IDE pivotal study and received FDA approval for a subset of adult patients with moderate to severe OSA [5]. Financial Communication - A conference call will take place on March 19, 2026, at 10:30 PM CET / 4:30 PM ET to discuss the financial results [1]. - The call will be accessible via the Investor Relations page of Nyxoah's website [2]. - For those wishing to ask questions, registration is required, and an email will be sent with dial-in details and a unique access code [3]. Additional Information - The archived webcast of the call will be available for replay shortly after the call concludes [3]. - For more information about Nyxoah and its products, the company encourages visiting its website [6].

Core Insights - Nyxoah reported strong preliminary results for Q4 and full year 2025, driven by successful U.S. commercialization of its Genio system for Obstructive Sleep Apnea (OSA) treatment [1][3] - The company anticipates continued revenue growth, with guidance indicating a 25% increase in U.S. net revenue for Q1 2026 compared to Q4 2025 [8] Financial Performance - For Q4 2025, gross revenue is expected to be approximately €6.3 million, with net revenue around €5.7 million, marking a 348% increase from €1.3 million in Q4 2024 [7] - Full year 2025 gross revenue is projected at €11.0 million, with net revenue of approximately €10.0 million, representing a 122% increase from €4.5 million in 2024 [7] - U.S. gross revenue for Q4 2025 is expected to be about €3.9 million, with net revenue around €3.5 million after deferred revenue deductions [7] Market Expansion and Strategy - The company has trained 145 surgeons on the Genio system and activated 57 accounts in the U.S. as of December 31, 2025 [7] - Nyxoah aims to expand Genio adoption in the U.S. throughout 2026, supported by a waiting list for additional surgeon training and patient implants [3] Upcoming Events - Nyxoah will present at the 44th Annual J.P. Morgan Healthcare Conference on January 15, 2026, at 12:00 p.m. Pacific Time [5]

Core Insights - Nyxoah reported strong initial results following the U.S. launch of its Genio system for treating Obstructive Sleep Apnea (OSA), achieving first revenue within a month post-FDA approval [2][4][5] Financial Highlights - Revenue for Q3 2025 was €2.0 million, a 56% increase year-over-year from €1.3 million in Q3 2024 [8][9] - The company reported a gross profit of €1.2 million with a gross margin of 60.5% for Q3 2025, compared to a gross margin of 62.0% in Q3 2024 [9][11] - Operating loss for Q3 2025 was €24.4 million, up from €15.0 million in Q3 2024, primarily due to increased selling, general, and administrative expenses [13][12] Market Launch and Strategy - The company executed a two-pronged launch strategy targeting high-volume hypoglossal nerve stimulation centers and building referral networks with sleep physicians [5][6] - As of October 31, 2025, 111 surgeons were trained on the Genio system, with 9 accounts having implanted the device [6] Reimbursement Progress - Significant progress was made in securing reimbursement coverage, with updates from major payors like Health Care Service Corporation and Blue Cross Blue Shield of Michigan, impacting over 26 million members [7][8] Cash Position - As of September 30, 2025, cash, cash equivalents, and financial assets totaled €22.5 million, down from €43.0 million at the end of June 30, 2025 [14]

Core Viewpoint - Nyxoah has received FDA approval for its Genio system, a novel treatment for obstructive sleep apnea (OSA), marking a significant advancement in the U.S. market for OSA therapies [2][4]. Company Overview - Nyxoah is a medical technology company focused on innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [7]. - The company aims to enhance the quality of life for OSA patients by providing effective treatment options [7]. Product Details - The Genio system utilizes bilateral stimulation and is designed to be MRI compatible, offering a non-implanted battery solution controlled by a wearable component [3]. - The wearable component is fully upgradable, allowing patients to access technological advancements without additional surgeries [3]. Clinical Data - The FDA approval was based on the DREAM pivotal trial, which demonstrated a 63.5% AHI responder rate and a 71.3% Oxygen Desaturation Index responder rate, with a median AHI reduction of 70.8% [4]. - Notably, 82.0% of subjects in the DREAM study achieved AHI scores below 15 [4]. - The study also showed efficacy across different sleeping positions, with a median AHI reduction of 66.6% in the supine position, which is significant given the increased airway obstruction risk in that position [5][6]. Market Impact - The approval of the Genio system expands treatment options for physicians managing OSA, particularly due to its consistent efficacy across various sleeping positions [6]. - The company is poised to execute its U.S. commercialization strategy following this approval [4].

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]