Nyxoah Reports Third Quarter 2026 Financial and Operating Results
Final 2027 Medicare facility reimbursement rates for Genio increase approximately 11% in hospital outpatient settings and 13% in surgery centers.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Nyxoah (NYXH) reported third-quarter 2026 global net revenue of €9.2 million, supported by continued expansion of U.S. commercialization. Revenue rose 19% sequentially; U.S. revenue reached €6.7 million, up 29% from the second quarter. Gross margin increased to 63.1% from 60.5% a year earlier. Net loss narrowed to €17.830 million from €23.580 million.
The ACCCESS study met its efficacy and safety endpoints in patients with complete concentric collapse, a pattern of airway closure. Nyxoah submitted an FDA application supplement to expand Genio’s U.S. indication to these patients; approval remains pending. Cash, cash equivalents and financial assets totaled €77.1 million at September 30, down from €97.8 million at June 30. The company expects full-year revenue of €33 million to €35 million and gross margin of 60% to 62%.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointACCCESS met co-primary efficacy endpoints, with a 77.2% 12-month apnea-hypopnea index responder rate (p<0.001).
- Moderate pointQ3 global revenue of €9.2 million grew 19% sequentially, versus €2.0 million a year earlier.
- Moderate pointQ3 gross margin of 63.1% increased from 60.5% a year earlier.
- Moderate pointQ3 net loss narrowed to €17.830 million from €23.580 million a year earlier.
- Moderate pointFDA application supplement submitted to expand Genio’s U.S. indication to complete concentric collapse patients.
- Moderate point. Forward-looking: it has not happened yet and may not happen.2027 hospital outpatient reimbursement increases approximately 11%, from $31,526 to $35,072 for the Genio procedure.
- Moderate point. Forward-looking: it has not happened yet and may not happen.2027 ambulatory surgical center reimbursement increases approximately 13%, from $27,563 to $31,283.
- Moderate point. Forward-looking: it has not happened yet and may not happen.2026 global revenue guidance is €33 million to €35 million; expected gross margin is 60% to 62%.
- Moderate pointNine-month revenue increased to €23.217 million from €4.376 million a year earlier.
12 minor points
- Minor pointQ3 U.S. revenue of €6.7 million grew 29% sequentially, accelerating from 22% in Q2.
- Minor pointQ3 operating loss narrowed to €21.868 million from €24.369 million a year earlier.
- Minor pointQ3 basic and diluted loss per share narrowed to €0.177 from €0.630 a year earlier.
- Minor point80 surgeons trained in Q3 brought the total trained to 342.
- Minor point53 accounts activated in Q3 brought active Genio accounts to 233.
- Minor point447 patients were actively undergoing prior authorization entering Q4.
- Minor pointACCCESS met safety endpoints, with zero device- and procedure-related serious adverse events.
- Minor pointNine-month gross profit increased to €14.006 million from €2.701 million a year earlier.
- Minor pointNine-month operating loss narrowed to €62.957 million from €64.857 million a year earlier.
- Minor pointNine-month basic and diluted loss per share narrowed to €0.992 from €1.778 a year earlier.
- Minor pointResearch and development expenses declined in Q3 and nine months to €11.777 million and €30.124 million, respectively.
- Minor pointQ3 financial income increased to €7.288 million from €1.082 million a year earlier.
Negative
- Moderate pointCash, cash equivalents and financial assets fell to €77.1 million at September 30 from €97.8 million at June 30.
- Moderate pointNine-month selling, general and administrative expenses rose to €47.011 million from €35.765 million a year earlier.
- Moderate pointFDA approval remains pending for the proposed U.S. indication expansion to complete concentric collapse patients.
- Moderate pointNon-current financial debt increased to €34.364 million at September 30 from €17.670 million at December 31, 2025.
- Minor pointQ3 selling, general and administrative expenses rose to €16.019 million from €12.702 million a year earlier.
4 minor points
- Minor pointNine-month net loss widened to €66.737 million from €66.572 million a year earlier.
- Minor pointQ3 financial expense increased to €2.942 million from €0.583 million a year earlier.
- Minor pointNine-month financial expense increased to €8.807 million from €8.162 million a year earlier.
- Minor pointNine-month financial income decreased to €6.199 million from €6.561 million a year earlier.
News Explained
For 2027, CMS’s final facility-reimbursement rule raises hospital outpatient reimbursement for the Genio procedure from
Key Figures
- Global net revenue
- €9.2 million
- Q3 2026; 19% sequential growth over Q2 2026
- U.S. net revenue
- €6.7 million
- Q3 2026; 29% sequential growth over Q2 2026
- 12-month AHI responder rate
- 77.2% (p<0.001)
- ACCCESS study in Complete Concentric Collapse patients
- Device- and procedure-related serious adverse events
- 0
- ACCCESS study results in Complete Concentric Collapse patients
- Gross margin
- 63.1%
- Q3 2026, compared with 60.5% in Q3 2025
- Operating loss
- €21.9 million
- Q3 2026, compared with €24.4 million in Q3 2025
- Full-year revenue guidance
- €33 million to €35 million
- Global net revenue, FY 2026
- Cash, cash equivalents and financial assets
- €77.1 million
- As of September 30, 2026
Previous Earnings Reports
-
Preliminary Q3 sales and ACCCESS data accompanied lower 2026 revenue guidance.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
pma supplement regulatory
opps regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
REGULATED INFORMATION
Nyxoah Reports Third Quarter 2026 Financial and Operating Results
Global net revenue was
PMA supplement submitted to the FDA to expand Genio’s U.S. indication to include Complete Concentric Collapse patients
Mont-Saint-Guibert, Belgium – November 5, 2026, 10:05 pm CET / 4:05 pm ET – 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 2026.
Q3 2026 Financial and Operating Highlights
- Financials
- Global net revenue for the third quarter of 2026 was
€9.2 million ,19% sequential growth over global net revenue for the second quarter of 2026 - U.S. net revenue for the third quarter of 2026 was
€6.7 million ,29% sequential growth over U.S. net revenue for the second quarter of 2026
- Global net revenue for the third quarter of 2026 was
- Leading U.S. commercial indicators
- 80 new surgeons trained in Q3, bringing the total to 342 surgeons trained
- 53 new accounts activated in Q3, bringing the total to 233 active Genio accounts
- 447 patients actively undergoing prior authorization entering Q4
- Clinical and Regulatory
- ACCCESS U.S. pivotal study met its co-primary efficacy endpoints and its safety endpoints in Complete Concentric Collapse (CCC) patients, with a 12-month AHI responder rate of
77.2% (p<0.001) and zero device- and procedure-related serious adverse events - Submitted a premarket approval (PMA) supplement to the FDA to expand Genio’s U.S. indication to include CCC patients
- Complete 12-month ACCCESS dataset presented at the International Surgical Sleep Society (ISSS) annual meeting, October 15-16, 2026
- ACCCESS U.S. pivotal study met its co-primary efficacy endpoints and its safety endpoints in Complete Concentric Collapse (CCC) patients, with a 12-month AHI responder rate of
- U.S. reimbursement
- CMS published its final rule on 2027 facility reimbursement for the Genio procedure
- Hospital outpatient (OPPS) reimbursement under C-code C8011 increases from
$31,526 t o$35,072 , or approximately11% - Ambulatory surgical center (ASC) reimbursement increases from
$27,563 t o$31,283 , or approximately13%
- Hospital outpatient (OPPS) reimbursement under C-code C8011 increases from
- CMS published its final rule on 2027 facility reimbursement for the Genio procedure
- Liquidity
- As of September 30, 2026, cash, cash equivalents and financial assets amounted to
€77.1 million
- As of September 30, 2026, cash, cash equivalents and financial assets amounted to
“We delivered
Results for the Three Months Ended September 30, 2026
Revenue
Net revenue for the third quarter of 2026 was
Gross Margin
Gross profit for the third quarter of 2026 was
Operating Loss
Total operating loss for the third quarter of 2026 was
Cash Position
Cash, cash equivalents and financial assets totaled
Financial Guidance for the Full Year 2026
- The Company expects global net revenue for the full year 2026 to be in the range of
€33 million to€35 million . - The Company expects gross margin for the full year 2026 to be in the range of
60% to62% .
Conference call and webcast presentation
Company management will host a conference call to discuss financial results on Thursday, November 5, 2026, beginning at 10:30 pm CET / 4:30 pm 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 2026 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 2026 Earnings Call. After registering, an email will be sent, including dial-in details and a unique conference call access code 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 in 2024 and received approval from the FDA in August 2025, with the treatment of CCC patients included in the warning section of our indications for use.
For more information, please visit http://www.nyxoah.com.
Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.
Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or management’s current expectations regarding the Genio system; the ACCCESS study and the results thereof; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the PMA supplement submitted to the FDA and the timing and outcome of the FDA review; the Company’s commercialization strategy in the U.S. market; the Company’s results of operations, financial condition, liquidity, performance, prospects, growth, future revenue, future operating expenses, future gross margins and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2026 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited) (in thousands)
| For the three months ended September 30 | For the nine months ended September 30 | ||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||
| Revenue | 9 170 | 1 972 | 23 217 | 4 376 | |||||
| Cost of goods sold | (3 385) | (779) | (9 211) | (1 675) | |||||
| Gross profit | |||||||||
| Research and Development Expense | (11 777) | (12 911) | (30 124) | (31 959) | |||||
| Selling, General and Administrative Expense | (16 019) | (12 702) | (47 011) | (35 765) | |||||
| Other income/(expense) | 143 | 51 | 172 | 166 | |||||
| Operating loss for the period | |||||||||
| Financial income | 7 288 | 1 082 | 6 199 | 6 561 | |||||
| Financial expense | (2 942) | (583) | (8 807) | (8 162) | |||||
| Loss for the period before taxes | |||||||||
| Income taxes | (308) | 290 | (1 172) | (114) | |||||
| Loss for the period | |||||||||
| Loss attributable to equity holders | |||||||||
| Other comprehensive loss | |||||||||
| Items that may be subsequently reclassified to profit or loss (net of tax) | |||||||||
| Currency translation differences | (298) | (33) | (297) | 197 | |||||
| Total comprehensive loss for the period, net of tax | |||||||||
| Loss attributable to equity holders | |||||||||
| Basic Loss Per Share (in EUR) | |||||||||
| Diluted Loss Per Share (in EUR) | |||||||||
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited) (in thousands)
| As at | |||||
| September 30 2026 | December 31 2025 | ||||
| ASSETS | |||||
| Non-current assets | |||||
| Property, plant and equipment | 4 168 | 4 052 | |||
| Intangible assets | 46 820 | 50 108 | |||
| Right of use assets | 1 843 | 1 293 | |||
| Deferred tax asset | 10 | 87 | |||
| Other long-term receivables | 1 825 | 1 718 | |||
| Current assets | |||||
| Inventory | 4 782 | 4 660 | |||
| Trade receivables | 7 848 | 5 254 | |||
| Contract assets | 453 | 261 | |||
| Other receivables | 2 117 | 2 209 | |||
| Other current assets | 1 785 | 828 | |||
| Financial assets | 61 644 | 18 000 | |||
| Cash and cash equivalents | 15 430 | 30 001 | |||
| Total assets | |||||
| EQUITY AND LIABILITIES | |||||
| Share capital and reserves | |||||
| Share capital | 7 093 | 6 505 | |||
| Share premium | 417 252 | 335 134 | |||
| Share based payment reserve | 13 898 | 12 395 | |||
| Other comprehensive income | 827 | 1 124 | |||
| Retained loss | (371 110) | (306 029) | |||
| Total equity attributable to shareholders | |||||
| LIABILITIES | |||||
| Non-current liabilities | |||||
| Financial debt | 34 364 | 17 670 | |||
| Lease liability | 1 397 | 637 | |||
| Provisions | 1 405 | 1 396 | |||
| Deferred tax liability | 68 | − | |||
| Contract liability | 678 | 681 | |||
| Current liabilities | |||||
| Financial debt | 17 545 | 23 428 | |||
| Lease liability | 551 | 779 | |||
| Trade payables | 12 555 | 13 727 | |||
| Current tax liability | 4 153 | 3 939 | |||
| Contract liability | 1 416 | 894 | |||
| Other liabilities | 6 633 | 6 191 | |||
| Total liabilities | |||||
| Total equity and liabilities | |||||
Contacts:
Nyxoah
Loïc Moreau, Interim CFO
Rémi Renard, Head of Investor Relations & Corporate Communication
Attachment
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is Nyxoah’s full-year 2026 financial guidance?
Nyxoah expects 2026 global net revenue of €33 million to €35 million and gross margin of 60% to 62%.
How will 2027 Medicare facility reimbursement change for Nyxoah’s Genio procedure?
The final 2027 rates increase Genio hospital outpatient reimbursement to $35,072 and ambulatory surgical center reimbursement to $31,283. Hospital outpatient reimbursement under C-code C8011 rises from $31,526, approximately 11%; the surgery center rate rises from $27,563, approximately 13%.