Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH), חברת טכנולוגיות רפואיות המפתחת חלופות טיפול פורצות דרך לדום נשימה חסימתי בשינה (OSA), דיווחה היום על תוצאות כספיות ותפעוליות לרבעון הראשון של 2026.
Nyxoah Reports First Quarter 2026 Financial and Operating Results
Strong Genio launch in the U.S. drove 25% sequential quarterly U.S. revenue growth
Continued clarity around HGNS and Genio reimbursement in the U.S.
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the first quarter of 2026.
Q1 2026 Financial and Operating Highlights
- Financials
- U.S. net revenue first quarter 2026 was €4.3 million (gross revenue was €4.5 million), 25% sequential growth over net revenue fourth quarter 2025
- Global net revenue first quarter 2026 was €6.4 million (gross revenue was €6.7 million), 13% sequential growth over net revenue fourth quarter 2025
- Leading U.S. commercial indicators
- 62 new surgeons trained in Q1, bringing the total to 207 surgeons trained
- 34 new accounts activated in Q1, bringing the total to 91 active high-volume accounts
- 241 patients submitted under prior authorization and still pending at the end of Q1
- U.S. reimbursement landscape – further clarified
- Medicare issued new C-Codes covering Genio and clarified facility and physician payments
- Commercial payers continued reimbursement under existing CPT codes
- 100% prior-authorization approval obtained on reviewed submissions with commercial payers and WISeR program
- As of March 31, 2026, cash, cash equivalents and financial assets amounted to €25.9 million. In the second quarter of 2026, the Company expects to draw €13.8 million from the second tranche of the European Investment Bank loan.
“Our first quarter revenue results reflect strong execution of our U.S. launch. The 25% sequential quarterly revenue growth was driven by continued strong activity in existing sites, and high growth in new site openings. We continue to see a consistent reimbursement landscape and had a 100% approval rate on closed U.S. prior authorization submissions as of the end of Q1 2026. Reimbursement did not hinder our first quarter results,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Entering our third full quarter of U.S. commercialization, we remain focused on further expanding account activation, treating more patients in active accounts and maintaining operating discipline to deliver sustainable revenue growth in the U.S.”
Results for the Three Months Ended March 31, 2026
Revenue
Gross revenue for the first quarter of 2026 was €6.7 million before €0.3 million of deferred revenue mainly related to disposable patches which are delivered over time. Net revenue was €6.4 million, compared to €1.1 million in the first quarter of 2025. The increase in net revenue was primarily driven by the continued expansion of U.S. commercialization activities following FDA approval in August 2025, as well as growth in international markets.
Cost of Goods Sold
Cost of goods sold was €2.7 million for the first quarter of 2026, resulting in a gross profit of €3.6 million and a gross margin of 57%, compared to cost of goods sold of €0.4 million and a gross margin of 62% in the first quarter of 2025. The increase in cost of goods sold was driven by higher volumes associated with the U.S. commercialization. The decrease in gross margin reflects production yield issues which have been addressed.
Research and Development
For the first quarter of 2026, research and development expenses were €8.8 million, versus €9.0 million for the first quarter of 2025. The decrease in research and development expenses reflects reduced investments in clinical study costs such as DREAM and ACCCESS.
Selling, General and Administrative
For the first quarter of 2026, selling, general and administrative expenses were €15.4 million, versus €12.4 million for the first quarter of 2025. The increase in selling, general and administrative expenses was primarily driven by the continued build-out of the Company’s U.S. commercial organization, including sales, marketing, and market access functions.
Operating Loss
Total operating loss for the first quarter of 2026 was €20.5 million, versus €20.6 million in the first quarter of 2025. The change in operating loss reflects increased net revenue offset by increased commercial investments to support U.S. launch activities, as well as continued investment in research and development.
Cash Position
Cash, cash equivalents and financial assets amounted to approximately €25.9 million at March 31, 2026.
In the second quarter of 2026, the Company expects to draw €13.8 million from the second tranche of the European Investment Bank loan.
Financial Guidance for the Second Quarter of 2026 and Full Year 2026
- The Company expects U.S. net revenue for the second quarter of 2026 to grow sequentially by approximately 25-30% over the first quarter of 2026.
- The Company expects worldwide net revenue for the full year 2026 to be in the range of €36 million to €40 million.
- The Company expects the gross margin for the full year 2026 to be in the range of 60% to 62%.
- The Company expects total operating expenses for the full year 2026 to be in the range of €97 million to €99 million. The Company expects non-GAAP cash operating expenses for the full year 2026 to be in the range of €88 million to €90 million. Non-GAAP cash operating expenses reflect expected total operating expenses less non-cash expenses such as depreciation, amortization, and share-based compensation.
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/.