Nyxoah מדווחת על תוצאות כספיות ותפעוליות לרבעון השלישי של 2025
מון-סן-גיבר, בלגיה – 13 בנובמבר 2025, GLOBE NEWSWIRE
Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH), חברת טכנולוגיות רפואיות המפתחת חלופות טיפול פורצות דרך לדום נשימה בשינה (OSA) באמצעות נוירומודולציה, דיווחה היום על תוצאות כספיות ותפעוליות לרבעון השלישי של 2025.
REGULATED INFORMATION
Nyxoah Reports Third Quarter 2025 Financial and Operating Results
US launch off to a strong start. First commercial Genio implants completed with widespread payer coverage drives initial revenue.
Mont-Saint-Guibert, Belgium – November 13, 2025, GLOBE NEWSWIRE
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2025.
Recent Financial and Operating Highlights
"The first weeks post FDA approval have been a huge success. We already completed the first implants in September. The response from physicians has been overwhelmingly positive, driven by the excitement of finally having real optionality in hypoglossal nerve stimulation for OSA patients," commented Olivier Taelman, Nyxoah's Chief Executive Officer. "We also secured reimbursement and generate the first U.S. revenue within the first month post FDA approval. The financing transaction announced today will support our sustained growth in the U.S. market. The momentum and enthusiasm couldn’t be greater."
Strong Initial U.S. Commercial Launch
The Company is executing its focused two-pronged launch strategy, targeting high-volume hypoglossal nerve stimulation implanting centers while developing strong referral networks with sleep physicians. The first commercial Genio devices were implanted at Townsend Memorial Health System in Houston, Texas, where the surgeon completed five procedures in the first week.
As of October 31, the Company has trained 111 surgeons on the Genio system, and 9 accounts implanted Genio. The Company has completed 102 value analysis committee submissions, with 35 approvals received, and has submitted 63 prior authorizations through their Genio Access Program (GAP), of which 21 approvals have been received. These metrics reflect the strong early traction the Company is seeing in the market and demonstrate the execution of its focused launch strategy.
Reimbursement Progress
The Company continues to make significant progress towards widespread reimbursement coverage with major payor policy updates and strategic partnerships that streamline patient access to the Genio system. Health Care Service Corporation (HCSC) operates Blue Cross Blue Shield plans in Illinois, Texas, Oklahoma, New Mexico, and Montana. HCSC and Blue Cross Blue Shield of Michigan have updated their hypoglossal nerve stimulation medical policies to include CPT Code 64568 as a referenced procedure code. While coverage for hypoglossal nerve stimulation was already established, the inclusion of this code provides additional clarity for providers and payors, which the Company expects will help reduce administrative barriers and streamline patient access. HCSC and BCBS of Michigan represent over 26 million members across six states.
Revenue
Revenue was €2.0 million for the third quarter ending September 30, 2025, compared to €1.3 million for the third quarter ending September 30, 2024, representing a 56% year over year increase.
Cost of Goods Sold
Cost of goods sold was €0.8 million for the third quarter ending September 30, 2025, representing a gross profit of €1.2 million, or gross margin of 60.5%. This compares to cost of goods sold of €482,000 in the third quarter ending September 30, 2024, for a gross profit of €0.8 million, or gross margin of 62.0%.
Research and Development
For the third quarter ending September 30, 2025, research and development ("R&D") expenses were €12.9 million, versus €7.9 million for the third quarter ending September 30, 2024. The increase in research and development expenses was primarily due to higher R&D activities. Additionally, following FDA approval in August 2025, the amortization of the related intangible assets commenced leading to an increase in depreciation and amortization expenses.
Selling, General and Administrative
For the third quarter ending September 30, 2025, selling, general and administrative expenses were €12.7 million, versus €8.0 million for the third quarter ending September 30, 2024. The increase in selling, general and administrative expenses was mainly due to an increase of costs to support the commercialization of Genio® system and the Company’s overall scale-up preparations for the commercialization of the Genio® system in the U.S. following receipt of FDA approval.
Operating Loss
Total operating loss for the third quarter ending September 30, 2025, was €24.4 million, versus €15.0 million in the third quarter 2024, respectively. This was driven by an increase in selling, general and administrative expenses to support commercialization of the Genio system, including the Company’s overall scale-up preparations for the commercialization of the Genio system in the US in connection with the receipt of FDA approval, and increased R&D and manufacturing activities, in addition to higher depreciation and amortization expenses.
Cash Position
As of September 30, 2025, cash, cash equivalents and financial assets totaled €22.5 million, compared to €43.0 million at the end of June 30, 2025.
Third Quarter 2025
Nyxoah’s financial report for the third quarter of 2025, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).
Conference call and webcast presentation
Company management will host a conference call to discuss financial results on Thursday, November 13, 2025, beginning at 10:30pm CET / 4:30pm ET.
A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q3 2025 Earnings Call Webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.
If you plan to ask a question, please use the following link: Nyxoah's Q3 2025 Earnings Call Q&A Line. required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.
The archived webcast will be available for replay shortly after the close of the call.
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65.
For more information, please visit http://www.nyxoah.com/.
Contacts:
Nyxoah John Landry, CFO [email protected]
Rémi Renard Chief Investor Relations & Corporate Communication Officer [email protected]
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