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]

Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for treating Obstructive Sleep Apnea (OSA) [3] - The company's lead product is the Genio system, which is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA [3] Recent Developments - Nyxoah will participate in the Oppenheimer 36th Annual Healthcare MedTech & Services Conference from March 16 to 19, 2026 [1] - CEO Olivier Taelman will present on March 16, 2026, at 8:40 am ET, with a webcast available on the company's Investor Relations website [2] - The company will also hold one-on-one meetings with institutional investors during the conference [2] Product Milestones - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4] - Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021 [4] - The company received CE mark approval for expanding therapeutic indications to Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study [4] - The FDA approved the Genio system for a subset of adult patients with moderate to severe OSA in August 2025 [4]

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 has signed a Memorandum of Understanding (MoU) with Sheikh Shakhbout Medical City (SSMC) to enhance Obstructive Sleep Apnea (OSA) therapy management and improve access to its Genio® therapy in the Middle East [1][2] Group 1: Partnership and Strategic Focus - The MoU aims to position SSMC as a leading regional center for Genio therapy, focusing on developing a high-volume implant program centered on patient care [2] - The collaboration includes establishing SSMC as a training hub for Genio therapy, educating surgeons, sleep physicians, and healthcare professionals across the region [3] Group 2: Clinical and Research Initiatives - Discussions are ongoing to explore clinical research and collaboration in sleep apnea and chronic disease management [3] - The initiative aligns with Nyxoah's vision to provide new treatment options for OSA patients and investigate the impact of advanced OSA management on chronic diseases like type 2 diabetes [4] Group 3: Company Overview and Product Information - Nyxoah specializes in developing innovative solutions for OSA, with its lead product being the Genio system, a leadless and battery-free hypoglossal neurostimulation therapy [5] - The Genio system received its European CE Mark in 2019 and has expanded its therapeutic indications following successful studies, including the BETTER SLEEP study and DREAM IDE pivotal study [6]

Core Viewpoint - Nyxoah is making a significant investment to expand its manufacturing capacity in Belgium to support growth in the U.S. and international markets [1][2][3] Group 1: Investment and Expansion - Nyxoah has signed an agreement with LégiaPark to create a nearly 2,000 square meters manufacturing facility, including a state-of-the-art cleanroom [2] - The investment aims to enhance Nyxoah's product development activities and strengthen its strategic partnership with Noshaq, contributing to local job creation [2][3] Group 2: Manufacturing and Technology - The new cleanroom facility is designed to be scalable, allowing for future growth alongside Nyxoah's manufacturing needs [3] - ABN Cleanroom Technology is collaborating with Nyxoah to develop the cleanroom, emphasizing innovation and local expertise in Belgium [3][9] Group 3: Company Overview - Nyxoah specializes in developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio system, a battery-free neurostimulation therapy [4][5] - The Genio system received its European CE Mark in 2019 and has expanded its therapeutic indications following successful studies [5]

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 Viewpoint - Nyxoah will present at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its innovative treatment for Obstructive Sleep Apnea (OSA) through the Genio system [1][2]. Company Overview - Nyxoah is a medical technology company focused on developing and commercializing solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [3]. - The company aims to improve the quality of life for OSA patients, who are at increased risk for mortality and cardiovascular issues [3]. Product Development and Regulatory Approvals - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4]. - Nyxoah has completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4]. - The company expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study, which are currently contraindicated in competitors' therapies [4]. - Nyxoah also announced positive results from the DREAM IDE pivotal study and received FDA approval in August 2025 for a subset of adult patients with moderate to severe OSA [4].

Core Viewpoint - Nyxoah SA has successfully issued the first tranche of convertible bonds amounting to €22.5 million as part of a larger financing plan of up to €45 million, aimed at supporting its operations and commercialization efforts in treating Obstructive Sleep Apnea (OSA) [1][2]. Group 1: Convertible Bonds Issuance - The first tranche of convertible bonds was issued for a nominal amount of €22.5 million, consisting of 225 bonds with a nominal value of €100,000 each, fully subscribed by Heights Capital Management (HCM) [2]. - A subscription fee of €1.8 million, equivalent to 8.0% of the principal amount, was paid to HCM, satisfied by set-off against the subscription price [2]. - The bonds carry an interest rate of 6.5% per annum and have a three-year maturity with quarterly amortization payments starting February 18, 2026 [3]. Group 2: Amortization and Conversion Rights - HCM has the right to bring forward the payment of up to two amortized payment amounts between scheduled amortization payment dates [4]. - HCM can convert the outstanding principal or any amortized payment amount at any time during the bond's term, with an initial conversion price set at €5.00 [5]. - Payments of amortized amounts can be made in cash or through the issuance of new ordinary shares, with the issue price determined by specific conditions [6]. Group 3: Future Tranche and Conditions - The company has the option to issue a second tranche of convertible bonds for an additional €22.5 million, contingent upon certain conditions being met between July 18, 2026, and August 18, 2026 [8]. - As of December 16, 2025, certain conditions precedent for the second tranche were not met, including daily traded values and market capitalization thresholds [10]. - The second tranche will be issued on similar terms as the first tranche, with the conversion price based on the lowest VWAP of the shares on the closing date [11]. Group 4: Cash Runway and Use of Proceeds - The issuance of the first tranche and the closing of capital increases will extend the company's cash runway into the third quarter of 2026, potentially extending to the first quarter of 2027 if the second tranche is issued [12]. - Net proceeds from the first tranche will be utilized for commercialization activities in the U.S., clinical data gathering, research and development, and general corporate purposes [13].

Core Viewpoint - Nyxoah is actively participating in the Piper Sandler 37th Annual Healthcare Conference, showcasing its innovative solutions for Obstructive Sleep Apnea (OSA) treatment [1]. Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [3]. - The company aims to improve the quality of life for OSA patients, allowing them to enjoy restful nights [3]. Product Development and Regulatory Approvals - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4]. - Nyxoah has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4]. - The company expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study, which are currently contraindicated in competitors' therapies [4]. - 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, specifically those with an Apnea-Hypopnea Index (AHI) of 15 to 65 [4].

Core Viewpoint - Nyxoah has secured financing commitments totaling up to U.S. $77 million to support the U.S. commercialization of its Genio system, which is designed to treat Obstructive Sleep Apnea (OSA) through neuromodulation [1][2]. Financing Details - The financing includes a €22 million private placement of equity, a U.S. $5.6 million registered direct offering, and a convertible bond financing of up to €45 million [2][7]. - The private placement involves the issuance of 5,481,678 new ordinary shares at a subscription price of €4.00 per share, generating gross proceeds of approximately €25 million [3]. - The registered direct offering consists of 1,215,964 new ordinary shares priced at U.S. $4.6304 per share, totaling approximately U.S. $5.6 million [5][6]. - The convertible bonds will have a maximum principal amount of up to €45 million, with the first tranche of €22.5 million expected to close in December 2025 [7]. Use of Proceeds - The net proceeds from the financing will be allocated to support U.S. commercialization activities, gather clinical data, finance research and development, and explore collaboration opportunities in OSA monitoring and diagnostics [8]. Company Background - Nyxoah is focused on developing innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [10]. - The Genio system received its European CE Mark in 2019 and FDA approval for certain adult patients in August 2025 [11][12].