Nyxoah Reports Second Quarter Financial and Operating Results
Nyxoah (NASDAQ:NYXH) has achieved a significant milestone with FDA approval of its Genio system, the first and only bilateral hypoglossal neurostimulation therapy for Obstructive Sleep Apnea (OSA) in the U.S. market. The company has initiated its commercial launch with strong Q2 2025 results, reporting revenue of €1.3 million, a 74% year-over-year increase.
The Genio system's approval was supported by the DREAM pivotal trial data, demonstrating 66.6% median AHI reduction in supine position and 71.0% reduction in non-supine position. The company's cash position stands at €43.0 million as of June 30, 2025, with an additional €27.5 million available through a term debt facility.
Operating loss increased to €19.9 million in Q2 2025, primarily due to expanded commercialization efforts and R&D activities.
Nyxoah (NASDAQ:NYXH) ha raggiunto un traguardo importante con l'approvazione FDA del suo sistema Genio, la prima e unica terapia di neurostimolazione bilaterale del nervo ipoglosso per l'apnea ostruttiva del sonno (OSA) sul mercato statunitense. L'azienda ha avviato il lancio commerciale ottenendo solidi risultati nel secondo trimestre 2025, riportando un fatturato di €1,3 milioni, in crescita del 74% su base annua.
L'approvazione del sistema Genio si basa sui dati dello studio fondamentale DREAM, che hanno mostrato una riduzione mediana dell'AHI del 66,6% in posizione supina e del 71,0% in posizione non supina. La posizione di cassa dell'azienda ammontava a €43,0 milioni al 30 giugno 2025, con ulteriori €27,5 milioni disponibili tramite una linea di debito a termine.
La perdita operativa è aumentata a €19,9 milioni nel secondo trimestre 2025, principalmente a causa dell'espansione delle attività commerciali e di ricerca e sviluppo.
Nyxoah (NASDAQ:NYXH) ha alcanzado un hito importante con la aprobación de la FDA de su sistema Genio, la primera y única terapia de neuroestimulación bilateral del nervio hipogloso para la apnea obstructiva del sueño (AOS) en el mercado de EE. UU. La compañía ha iniciado su lanzamiento comercial con sólidos resultados en el segundo trimestre de 2025, reportando ingresos de €1,3 millones, un aumento interanual del 74%.
La aprobación del sistema Genio se apoyó en los datos del ensayo pivotal DREAM, que demostraron una reducción mediana del IHA del 66,6% en posición supina y una reducción del 71,0% en posición no supina. La posición de efectivo de la compañía era de €43,0 millones al 30 de junio de 2025, con otros €27,5 millones disponibles mediante una facilidad de deuda a plazo.
La pérdida operativa aumentó a €19,9 millones en el segundo trimestre de 2025, principalmente debido a la ampliación de los esfuerzos de comercialización y las actividades de I+D.
Nyxoah (NASDAQ:NYXH)는 미국 시장에서 첫 번째이자 유일한 양측 설골신경(하설골) 신경자극 치료 기기인 Genio 시스템에 대해 FDA 승인을 받아 중요한 이정표를 달성했습니다. 회사는 상업 출시를 개시했으며 2025년 2분기에 매출 €1.3백만을 보고하며 전년 대비 74% 증가하는 강력한 실적을 기록했습니다.
Genio 시스템의 승인은 DREAM 중추 임상시험 데이터에 의해 뒷받침되었으며, 복와위(엎드린 자세)에서 중앙값 AHI 66.6% 감소, 비복와위에서 71.0% 감소를 보였습니다. 회사의 현금 보유액은 2025년 6월 30일 기준 €43.0백만이며, 추가로 €27.5백만이 기한부 채무 시설을 통해 이용 가능합니다.
영업손실은 상업화 확대 및 연구개발 활동으로 인해 2025년 2분기에 €19.9백만으로 증가했습니다.
Nyxoah (NASDAQ:NYXH) a franchi une étape importante avec l'approbation de la FDA de son système Genio, la première et unique thérapie de neurostimulation bilatérale du nerf hypoglosse pour l'apnée obstructive du sommeil (AOS) sur le marché américain. La société a lancé la commercialisation et affiche de solides résultats pour le deuxième trimestre 2025, déclarant un chiffre d'affaires de 1,3 M€, en hausse de 74% sur un an.
L'approbation du système Genio s'appuie sur les données de l'essai pivot DREAM, montrant une réduction médiane de l'IMAE de 66,6% en position supine et une réduction de 71,0% en position non supine. La trésorerie de la société s'élevait à 43,0 M€ au 30 juin 2025, avec 27,5 M€ supplémentaires disponibles via une facilité de dette à terme.
La perte d'exploitation a augmenté à 19,9 M€ au T2 2025, principalement en raison de l'expansion des efforts de commercialisation et des activités de R&D.
Nyxoah (NASDAQ:NYXH) hat einen wichtigen Meilenstein erreicht: Die FDA hat sein Genio-System zugelassen, die erste und einzige bilaterale Hypoglossus-Neurostimulationstherapie gegen obstruktive Schlafapnoe (OSA) auf dem US-Markt. Das Unternehmen hat den kommerziellen Start eingeleitet und starke Ergebnisse für Q2 2025 vorgelegt, mit einem Umsatz von €1,3 Mio., ein Anstieg von 74% gegenüber dem Vorjahr.
Die Zulassung des Genio-Systems stützt sich auf Daten der wegweisenden DREAM-Studie, die eine medianen AHI-Reduktion von 66,6% in Bauchlage (supin) und eine 71,0% Reduktion in Nicht-Bauchlage zeigten. Die Barreserve des Unternehmens belief sich zum 30. Juni 2025 auf €43,0 Mio., zusätzlich stehen €27,5 Mio. über eine Termkreditfazilität zur Verfügung.
Der Betriebsverlust stieg im Q2 2025 auf €19,9 Mio., hauptsächlich bedingt durch ausgeweitete Kommerzialisierungsmaßnahmen und F&E-Aktivitäten.
- FDA approval received for Genio system as first bilateral hypoglossal neurostimulation therapy in U.S.
- Revenue grew 74% year-over-year to €1.3 million in Q2 2025
- Strong clinical efficacy with 66.6% - 71.0% AHI reduction across sleeping positions
- Additional €27.5 million debt facility available based on revenue milestones
- Operating loss widened to €19.9 million from €13.3 million year-over-year
- Cash position decreased to €43.0 million from €63.0 million in previous quarter
- Gross margin slightly declined to 63.4% from 63.6% year-over-year
Insights
Nyxoah's FDA approval for Genio system marks major breakthrough in OSA treatment despite widening losses during US market entry phase.
The FDA approval of Nyxoah's Genio system represents a transformational milestone for the company in the competitive obstructive sleep apnea (OSA) market. As the first and only bilateral hypoglossal neurostimulation therapy approved in the US, Genio offers significant technological differentiation from existing competitors. The system's unique design features - bilateral stimulation, leadless architecture, and full-body MRI compatibility - create meaningful advantages for patients and clinicians.
The DREAM pivotal trial data published in the Journal of Clinical Sleep Medicine provides robust clinical validation, showing 66.6% median AHI reduction in the challenging supine sleeping position where airway obstructions typically double. This efficacy regardless of sleeping position is particularly significant as patients sleep in supine positions 35-40% of nights, addressing a limitation of competitive devices.
Financially, Nyxoah showed 74% year-over-year revenue growth with Q2 2025 revenue reaching
The accelerating cash burn is notable, with cash and financial assets declining to
The gross margin of
REGULATED INFORMATION
Nyxoah Reports Second Quarter Financial and Operating Results
FDA Approves Genio® System for U.S. Market; Company Begins Commercial Launch
Mont-Saint-Guibert, Belgium – August 18, 2025, 10:10pm CET / 4:10 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 second quarter of 2025.
Recent Financial and Operating Highlights
- Received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for the Genio system, the first and only bilateral hypoglossal neurostimulation therapy approved in the U.S.
- Kicked off the U.S. commercial launch of the Genio system
- DREAM pivotal study data published in the Journal of Clinical Sleep Medicine
- Revenue for the second quarter of 2025 was
€1.3 million , compared to€0.8 million in the second quarter of 2024, representing74% year over year growth - Cash, cash equivalents and financial assets were
€43.0 million at June 30, 2025, compared to€63.0 million at the end of March 31, 2025.
"This FDA approval represents a historic milestone for Nyxoah and marks the beginning of what we expect to be a transformational period for our company," commented Olivier Taelman, Nyxoah's Chief Executive Officer. "Genio is now the first and only bilateral hypoglossal neurostimulation therapy approved in the United States, offering a truly differentiated solution for OSA patients who have been underserved by existing therapies. Our world-class commercial team is in place, and we have begun to execute on our commercial strategy.”
FDA PMA Approval
As previously disclosed, on August 8, 2025, the Company received FDA PMA for its Genio system, marking a historic milestone for Nyxoah. Genio’s unique design utilizes bilateral stimulation, and offers patients a leadless, full-body 1.5T and 3T MRI compatible, non-implanted battery solution, powered and controlled by a wearable component.
The Genio system’s FDA approval was supported by the high-quality, differentiated safety and efficacy data from the Company's DREAM pivotal trial, which demonstrated that Genio is efficacious regardless of a patient's sleeping position. This is a critical differentiator as on average, people sleep in a supine position between
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)
| For the three months ended June 30 | For the six months ended June 30 | |||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||
| Revenue | 1 340 | 771 | 2 404 | 1 992 | ||||||||
| Cost of goods sold | ( 490) | ( 281) | ( 896) | ( 735) | ||||||||
| Gross profit | ||||||||||||
| Research and Development Expense | (10 059) | (7 472) | (19 048) | (14 671) | ||||||||
| Selling, General and Administrative Expense | (10 672) | (6 383) | (23 063) | (12 355) | ||||||||
| Other income | 31 | 58 | 115 | 249 | ||||||||
| Operating loss for the period | ||||||||||||
| Financial income | 2 858 | 2 069 | 5 480 | 3 477 | ||||||||
| Financial expense | (3 337) | (1 445) | (7 579) | (2 436) | ||||||||
| Loss for the period before taxes | ||||||||||||
| Income taxes | ( 278) | ( 441) | ( 404) | ( 551) | ||||||||
| 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 | 232 | ( 82) | 230 | ( 22) | ||||||||
| Total comprehensive loss for the year, 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 | ||||||
| June 30 2025 | December 31 2024 | |||||
| ASSETS | ||||||
| Non-current assets | ||||||
| Property, plant and equipment | 5 015 | 4 753 | ||||
| Intangible assets | 51 407 | 50 381 | ||||
| Right of use assets | 3 059 | 3 496 | ||||
| Deferred tax asset | 76 | 76 | ||||
| Other long-term receivables | 1 799 | 1 617 | ||||
| Current assets | ||||||
| Inventory | 5 332 | 4 716 | ||||
| Trade receivables | 1 330 | 3 382 | ||||
| Contract assets | 1 508 | − | ||||
| Other receivables | 3 014 | 2 774 | ||||
| Other current assets | 944 | 1 656 | ||||
| Financial assets | 20 257 | 51 369 | ||||
| Cash and cash equivalents | 22 729 | 34 186 | ||||
| Total assets | ||||||
| EQUITY AND LIABILITIES | ||||||
| Share capital and reserves | ||||||
| Share capital | 6 431 | 6 430 | ||||
| Share premium | 314 388 | 314 345 | ||||
| Share based payment reserve | 11 645 | 9 300 | ||||
| Other comprehensive income | 1 144 | 914 | ||||
| Retained loss | (260 211) | (217 735) | ||||
| Total equity attributable to shareholders | ||||||
| LIABILITIES | ||||||
| Non-current liabilities | ||||||
| Financial debt | 18 928 | 18 725 | ||||
| Lease liability | 2 157 | 2 562 | ||||
| Provisions | 404 | 1 000 | ||||
| Deferred tax liability | 34 | 19 | ||||
| Contract liability | 225 | 472 | ||||
| Other liability | 379 | 845 | ||||
| Current liabilities | ||||||
| Financial debt | 246 | 248 | ||||
| Lease liability | 1 071 | 1 118 | ||||
| Trade payables | 9 408 | 9 505 | ||||
| Current tax liability | 3 990 | 4 317 | ||||
| Contract liability | 460 | 117 | ||||
| Other liability | 5 771 | 6 224 | ||||
| Total liabilities | ||||||
| Total equity and liabilities | ||||||
Revenue
Revenue was
Cost of Goods Sold
Cost of goods sold was
Research and Development
For the second quarter ending June 30, 2025, research and development (“R&D”) expenses were
Selling, General and Administrative
For the second quarter ending June 30, 2025, selling, general and administrative expenses were
Operating Loss
Total operating loss for the second quarter ending June 30, 2025 was
Cash Position
As of June 30, 2025, cash, cash equivalents and financial assets totaled
Second Quarter 2025
Nyxoah’s financial report for the second 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 Monday, August 18, 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 Q2 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: Events | Nyxoah Investors 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/.
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 managements’ 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; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth 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
For Media
In United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com
For Media
Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be
International/Germany
MC Services – Anne Hennecke
nyxoah@mc-services.eu
Attachment
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