Nyxoah (NASDAQ: NYXH) reports preliminary 2025 results and Q1 2026 view
Rhea-AI Filing Summary
Nyxoah SA furnished a report highlighting preliminary, unaudited financial and operating results for the fourth quarter and full year 2025 and providing revenue guidance commentary for the first quarter of 2026. The Company’s first full quarter of U.S. commercialization after FDA approval generated what management describes as strong momentum, with early U.S. patients seeing positive outcomes, a waiting list for additional surgeon training, and patients already scheduled for implants.
Management stated that global revenue exceeded
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Insights
Nyxoah reports early U.S. launch traction with 2025 revenue above €10 million.
Nyxoah outlines preliminary, unaudited results for Q4 and full-year 2025, emphasizing its first full quarter of U.S. commercialization following FDA approval of the Genio system. Management highlights that global revenue exceeded
The commentary points to operational momentum: early U.S. patients are reported to be experiencing strong outcomes, there is a waiting list for additional surgeon training, and implants are already scheduled. These details suggest growing clinical adoption, but the absence of detailed financial metrics in this excerpt makes it difficult to gauge the scale of the ramp versus prior periods.
The Company also plans to present at the 44th Annual J.P. Morgan Healthcare Conference on
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of January 2026
Commission File Number: 001-40552
NYXOAH SA
(Translation of registrant’s name into English)
Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Nyxoah SA
On January 12, 2026, Nyxoah SA (the “Company”) issued a press release announcing its preliminary unaudited financial and operating results for the quarter and year ended December 31, 2025. The press release is attached as Exhibit 99.1 and is incorporated by reference herein.
Additionally, on January 12, 2026, the Company issued a press release, a copy of which is attached hereto as Exhibit 99.2.
The information in the attached Exhibit 99.1 and Exhibit 99.2 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
Exhibits
| 99.1 | Press Release, dated January 12, 2026 |
| 99.2 | Press Release, dated January 12, 2026 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| NYXOAH SA | ||
| Date: January 14, 2026 | By: | /s/ John Landry |
| Name: | John Landry | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2025 and Provides Revenue Guidance for the First Quarter of 2026
January 12, 2026
INSIDE INFORMATION
REGULATED INFORMATION
Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2025 and Provides Revenue Guidance for the First Quarter of 2026
Strong Start in First Full Quarter of U.S. Commercialization
Mont-Saint-Guibert, Belgium – January 12, 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 certain preliminary unaudited fourth quarter and full year 2025 financial and operating results.
Preliminary, Unaudited Fourth Quarter and Full Year 2025 Results
| · | For the fourth quarter of 2025, gross revenue is expected to be approximately €6.3 million before the deferral of approximately €0.6 million due to disposable patches that are to be delivered over time. Net revenue is expected to be approximately €5.7 million, representing an increase of approximately 348% over revenue of €1.3 million for the fourth quarter of 2024. U.S. gross revenue for the fourth quarter of 2025 is expected to be approximately €3.9m and net revenue (after deduction of deferred revenue) is expected to be approximately €3.5 million. |
| · | For the full year 2025, gross revenue is expected to be approximately €11.0 million before the deferral of approximately €1.0 million due to disposable patches that are to be delivered over time. Net revenue is expected to be approximately €10.0 million, representing an increase of approximately 122% over 2024 revenue of €4.5 million. U.S. gross revenue for the full year of 2025 is expected to be approximately €4.2m and net revenue (after deduction of deferred revenue) is expected to be approximately €3.7 million. |
| · | As of December 31, 2025, the Company has trained 145 surgeons on the Genio system and has activated 57 accounts in the U.S. |
| · | As of December 31, 2025, cash, cash equivalents and financial assets are expected to be approximately €47.9 million. |
“Our first full quarter of U.S. commercialization post-FDA approval resulted in strong momentum,” commented Olivier Taelman, Nyxoah's Chief Executive Officer. “Our first U.S. patients are experiencing great results; we have a waiting list for additional surgeon training and patients scheduled for implants. Global revenue exceeded €10 million due to the strong U.S. launch and further international geographical expansion. We have established a strong foundation for sustained growth and look forward to expanding Genio adoption in the U.S. throughout 2026.”
Revenue Guidance for the First Quarter of 2026
| · | We expect U.S. net revenue for the first quarter of 2026 to grow by approximately 25% over the fourth quarter of 2025. |
| · | International revenue is expected to follow a typical seasonal pattern. |
The preliminary, unaudited revenue results and cash, cash equivalents and financial assets described in this press release are estimates only and are subject to revision until Nyxoah reports its full financial results for 2025 in its Annual Report on Form 20-F.
Upcoming Investor Conference Presentation
The Company will be participating in the 44th Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2026. The Company is scheduled to present at 12:00 p.m. Pacific Time the same day via webcast. A live audio webcast of the presentation will be available online on the investor relations page of the Company’s website at investors.nyxoah.com.
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/.
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 potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company's commercialization strategy and entrance to the U.S. market; the Company's results of operations, financial condition, liquidity, performance, prospects, growth, future revenue 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, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 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.
Contacts:
Nyxoah
John Landry, CFO
IR@nyxoah.com
Rémi Renard
Head of Investor Relations & Corporate Communication
IR@nyxoah.com
Attachment
| · | ENGLISH_JP Morgan Prelim Earnings PR |
FAQ
What did Nyxoah (NYXH) report in its January 2026 Form 6-K?
Nyxoah furnished a Form 6-K summarizing a press release with preliminary, unaudited fourth quarter and full year 2025 results and commentary on revenue guidance for the first quarter of 2026. The filing also notes participation in the 44th Annual J.P. Morgan Healthcare Conference.
How much revenue did Nyxoah generate according to the preliminary 2025 results?
Management stated that Nyxoah’s global revenue exceeded
What does Nyxoah say about its U.S. commercialization progress?
Nyxoah describes its first full quarter of U.S. commercialization post-FDA approval as showing strong momentum, with positive patient outcomes, a waiting list for additional surgeon training, and patients already scheduled for implants.
Did Nyxoah provide revenue guidance for the first quarter of 2026?
Yes. Nyxoah indicated it is providing revenue guidance for the first quarter of 2026, noting that the preliminary revenue and cash figures discussed are estimates only and remain subject to revision until full 2025 results are reported in its Annual Report on Form 20-F.
When and where will Nyxoah present to investors at the J.P. Morgan Healthcare Conference?
Nyxoah plans to participate in the 44th Annual J.P. Morgan Healthcare Conference on
What is Nyxoah’s lead product and its regulatory status?
Nyxoah’s lead solution is the Genio system, a leadless, battery-free hypoglossal neurostimulation therapy for obstructive sleep apnea. The system has held a CE Mark since 2019 and received FDA approval in August 2025 as a prescription-only device for a defined subset of adult patients.
How does Nyxoah describe the nature of the preliminary figures in this update?
The Company notes that the preliminary, unaudited revenue results and cash, cash equivalents and financial assets referenced are estimates only and may be revised when Nyxoah files its full-year 2025 financial statements on Form 20-F.
