Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results
Nyxoah (NYXH) reported its Q4 and FY 2024 financial results, highlighting key developments in its Obstructive Sleep Apnea (OSA) treatment business. Q4 2024 revenue was €1.3 million (excluding €0.6 million deferred revenue), with a strong gross margin of 73%. Full-year 2024 revenue reached €4.5 million.
The company's cash position strengthened to €85.6 million as of December 31, 2024, up from €57.7 million year-over-year. Operating losses increased to €58.8 million for FY 2024, compared to €45.1 million in 2023, reflecting increased R&D and commercial activities.
Nyxoah completed its PMA submission to the FDA for its Genio system and expects approval by Q1 end. The company has assembled its U.S. commercial team and plans to launch in March 2025.
Nyxoah (NYXH) ha riportato i risultati finanziari del Q4 e dell'anno fiscale 2024, evidenziando sviluppi chiave nel suo business per il trattamento dell'Apnea Ostruttiva del Sonno (OSA). I ricavi del Q4 2024 sono stati di €1,3 milioni (escludendo €0,6 milioni di ricavi differiti), con un forte margine lordo del 73%. I ricavi dell'intero anno 2024 hanno raggiunto i €4,5 milioni.
La posizione di cassa dell'azienda è migliorata a €85,6 milioni al 31 dicembre 2024, rispetto ai €57,7 milioni dell'anno precedente. Le perdite operative sono aumentate a €58,8 milioni per l'anno fiscale 2024, rispetto ai €45,1 milioni del 2023, riflettendo un incremento delle attività di R&S e commerciali.
Nyxoah ha completato la sua presentazione PMA alla FDA per il sistema Genio e si aspetta l'approvazione entro la fine del primo trimestre. L'azienda ha assemblato il suo team commerciale negli Stati Uniti e prevede di lanciare il prodotto a marzo 2025.
Nyxoah (NYXH) informó sus resultados financieros del Q4 y del año fiscal 2024, destacando desarrollos clave en su negocio de tratamiento de la Apnea Obstructiva del Sueño (OSA). Los ingresos del Q4 2024 fueron de €1,3 millones (excluyendo €0,6 millones de ingresos diferidos), con un fuerte margen bruto del 73%. Los ingresos anuales de 2024 alcanzaron los €4,5 millones.
La posición de efectivo de la compañía se fortaleció a €85,6 millones al 31 de diciembre de 2024, en comparación con €57,7 millones del año anterior. Las pérdidas operativas aumentaron a €58,8 millones para el año fiscal 2024, en comparación con €45,1 millones en 2023, reflejando un aumento en las actividades de I+D y comerciales.
Nyxoah completó su presentación PMA a la FDA para su sistema Genio y espera aprobación para finales del primer trimestre. La compañía ha formado su equipo comercial en EE. UU. y planea lanzar en marzo de 2025.
Nyxoah (NYXH)는 2024년 4분기 및 연간 재무 결과를 보고하며, 폐쇄성 수면 무호흡증(OSA) 치료 사업의 주요 발전 사항을 강조했습니다. 2024년 4분기 수익은 €1.3백만(€0.6백만의 이연 수익 제외)으로, 73%의 높은 총 마진을 기록했습니다. 2024년 전체 연간 수익은 €4.5백만에 달했습니다.
회사의 현금 잔고는 2024년 12월 31일 기준으로 €85.6 백만으로 강화되었으며, 전년 대비 €57.7 백만에서 증가했습니다. 운영 손실은 2024 회계연도에 €58.8 백만으로 증가했으며, 2023년의 €45.1 백만과 비교됩니다. 이는 연구개발 및 상업 활동의 증가를 반영합니다.
Nyxoah는 Genio 시스템에 대한 FDA의 PMA 제출을 완료했으며, 1분기 말까지 승인을 기대하고 있습니다. 회사는 미국 상업 팀을 구성했으며 2025년 3월에 출시할 계획입니다.
Nyxoah (NYXH) a annoncé ses résultats financiers du Q4 et de l'exercice 2024, mettant en avant des développements clés dans son activité de traitement de l'Apnée Obstructive du Sommeil (OSA). Le chiffre d'affaires du Q4 2024 s'élevait à 1,3 million d'euros (hors 0,6 million d'euros de revenus différés), avec une forte marge brute de 73 %. Le chiffre d'affaires annuel 2024 a atteint 4,5 millions d'euros.
La position de trésorerie de l'entreprise s'est renforcée à 85,6 millions d'euros au 31 décembre 2024, contre 57,7 millions d'euros l'année précédente. Les pertes d'exploitation ont augmenté à 58,8 millions d'euros pour l'exercice 2024, contre 45,1 millions d'euros en 2023, reflétant une augmentation des activités de R&D et commerciales.
Nyxoah a complété sa soumission PMA à la FDA pour son système Genio et s'attend à une approbation d'ici la fin du premier trimestre. L'entreprise a constitué son équipe commerciale aux États-Unis et prévoit de lancer le produit en mars 2025.
Nyxoah (NYXH) hat seine finanziellen Ergebnisse für das 4. Quartal und das Geschäftsjahr 2024 veröffentlicht und dabei wichtige Entwicklungen in seinem Geschäft zur Behandlung von obstruktiver Schlafapnoe (OSA) hervorgehoben. Der Umsatz im 4. Quartal 2024 betrug 1,3 Millionen € (ohne 0,6 Millionen € aufgeschobene Einnahmen) und wies eine starke Bruttomarge von 73 % auf. Der Jahresumsatz 2024 erreichte 4,5 Millionen €.
Die Liquiditätsposition des Unternehmens verbesserte sich auf 85,6 Millionen € zum 31. Dezember 2024, ein Anstieg von 57,7 Millionen € im Vergleich zum Vorjahr. Die operativen Verluste stiegen auf 58,8 Millionen € für das Geschäftsjahr 2024, verglichen mit 45,1 Millionen € im Jahr 2023, was die gestiegenen F&E- und Geschäftstätigkeiten widerspiegelt.
Nyxoah hat seine PMA-Einreichung bei der FDA für sein Genio-System abgeschlossen und erwartet die Genehmigung bis Ende des ersten Quartals. Das Unternehmen hat sein kommerzielles Team in den USA zusammengestellt und plant die Markteinführung im März 2025.
- Strong Q4 2024 gross margin of 73%, improved from 60% year-over-year
- Cash position increased significantly to €85.6 million from €57.7 million YoY
- Q4 revenue growth of 46% quarter-over-quarter (including deferred revenue)
- FDA approval expected soon with commercial launch readiness
- Operating loss widened to €58.8 million from €45.1 million YoY
- Increased R&D and SG&A expenses impacting bottom line
- Revenue recognition affected by new accounting treatment for disposable patches
Insights
Nyxoah's Q4 and FY 2024 results show a company in pre-commercialization transition with several positive indicators despite increased operating losses. Revenue reached
The company's strong cash position of
The pending FDA approval for Genio (expected by end of Q1) represents the most significant near-term catalyst. Management's confidence is evidenced by their investment in a complete US commercial organization ahead of approval. The OSA neuromodulation market represents substantial untapped potential, and Nyxoah's positioning with a reportedly best-in-class clinical profile from their DREAM study could drive significant revenue acceleration in the latter part of 2025.
Nyxoah's Genio system stands at a critical inflection point with FDA approval appearing imminent. The company's reference to "best-in-class outcomes" from their DREAM pivotal study suggests competitive clinical differentiation in the neuromodulation space for OSA treatment. The company has strategically prioritized the US market, which represents the largest opportunity for OSA devices given reimbursement pathways and patient volumes.
The preparation of a complete US commercial infrastructure before approval reflects management's confidence in the regulatory outcome and demonstrates lessons learned from other medical device rollouts where commercial readiness lagged behind approval. The fully assembled sales, marketing, and market access teams will be important for physician education, reimbursement navigation, and adoption in the competitive US sleep medicine landscape.
The
REGULATED INFORMATION
Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results
FDA PMA Application Review Nearing Conclusion
Positioned for U.S. Commercial Launch in March 2025
Mont-Saint-Guibert, Belgium – March 13, 2024, 7:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the fourth quarter and financial year 2024.
Recent Financial and Operating Highlights
- Revenue for the fourth quarter of 2024 was
€1. 3 million, which excludes€0.6 million of deferred revenue - Revenue for the full year 2024 was €4.5 million, which excludes
€0.6 million of deferred revenue - Gross margin for the fourth quarter of 2024 was
73% - At December 31, 2024, cash and financial assets were €85.6 million, compared to
€57.7 million at December 31, 2023 - Assembled U.S. executive leadership team with deep industry experience
- Full U.S. commercial organization, including sales, marketing, and market access teams, in place
"2024 was a transformative year for Nyxoah. We reported best-in-class outcomes from our DREAM pivotal study, completed our PMA submission with the FDA for Genio, and built a world-class U.S. commercial organization,” commented Olivier Taelman, Nyxoah's Chief Executive Officer. “We believe an approval is still expected by the end of the first quarter, and we look forward to launching this innovative therapy to the millions of Americans suffering from moderate to severe OSA.”
Fourth Quarter and Full Year 2024 Results
Revenue
In the fourth quarter of 2024, the Company began recording a portion of the selling price for a Genio system related to disposable patches as deferred revenue and recognized
Cost of Goods Sold
Cost of goods sold was €0.3 million for the three months ending December 31, 2024, representing a gross profit of €0.9 million, or gross margin of 73%. This compares to total cost of goods sold of €0.7 million in the fourth quarter of 2023, for a gross profit of
For the full year ending December 31, 2024, total cost of goods sold was €1.5 million, representing a gross profit of €3.0 million, or gross margin of 66%. This compares to total cost of goods sold of
Research and Development
For the fourth quarter ending December 31, 2024, research and development expenses were €11.7 million, versus €7.3 million for the fourth quarter ending December 31, 2023. For the full year ending December 31, 2024, research and development expenses were €34.3 million, versus
Selling, General and Administrative
For the fourth quarter ending December 31, 2024, selling, general and administrative expenses were €8.1million, versus €4.9 million for the fourth quarter ending December 31, 2023. For the full year ending December 31, 2024, selling, general and administrative expenses were
Operating Loss
Total operating loss for the fourth quarter and full year 2024 was €18.3 million and €58.8 million, respectively, versus
Cash Position
As of December 31, 2024, cash and financial assets totaled
Annual Report 2024
Nyxoah is currently finalizing the financial statements for the year ended December 31, 2024. The Company’s independent auditor has confirmed that their audit procedures, which have been substantially completed, have not revealed any material adjustments which would have to be made to the accounting information included in this press release. The complete consolidated financial statements for the year ended December 31, 2024 as well as the complete audit report related to the audit of the consolidated financial statements will be included in the 2024 Annual Report which the Company aims to publish on or around March 20, 2025. When published, the Nyxoah Annual Report for the financial year 2024 will be 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, March 13, 2025, beginning at 1:00pm CET / 8:00am ET.
A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q4 and FY 2024 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 Q4 and FY 2024 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.
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)
|
| For the three months ended December 31, |
| For the twelve months ended December 31, | ||||
|
| 2024 |
| 2023 |
| 2024 |
| 2023 |
| Revenue | 1 263 |
| 1 824 |
| 4 521 |
| 4 348 |
| Cost of goods sold | (335) |
| (726) |
| (1 552) |
| (1 656) |
| Gross profit | € 928 |
| |
| € 2 969 |
| |
| Research and Development Expense | (11 752) |
| (7 321) |
| (34 325) |
| (26 651) |
| Selling, General and Administrative Expense | (8 065) |
| (4 893) |
| (28 461) |
| (21 687) |
| Other income/(expense) | 578 |
| 279 |
| 1 008 |
| 544 |
| Operating loss for the period | €(18 311) |
| |
| €(58 809) |
| |
| Financial income | 2 832 |
| 582 |
| 7 447 |
| 4 174 |
| Financial expense | 410 |
| (964) |
| (5 070) |
| (3 729) |
| Loss for the period before taxes | €(15 069) |
| |
| €(56 432) |
| |
| Income taxes | (2 080) |
| 326 |
| (2 804) |
| 1 445 |
| Loss for the period | €(17 149) |
| |
| €(59 236) |
| |
|
|
|
|
|
|
|
|
|
| Loss attributable to equity holders | €(17 149) |
| |
| €(59 236) |
| |
|
|
|
|
|
|
|
|
|
| Other comprehensive income/(loss) |
|
|
|
|
|
|
|
| Items that may not be subsequently reclassified to profit or loss (net of tax) |
|
|
|
|
|
|
|
| Remeasurements of post-employment benefit obligations, net of tax | 11 |
| 81 |
| 11 |
| 81 |
| Items that may be subsequently reclassified to profit or loss (net of tax) |
|
|
|
|
|
|
|
| Currency translation differences | 545 |
| (32) |
| 766 |
| (120) |
| Total other comprehensive income/(loss) | €556 |
| |
| |
| |
| Total comprehensive loss for the year, net of tax | €(16 151) |
| |
| €(58 459) |
| |
| Loss attributable to equity holders | €(16 151) |
| |
| €(58 459) |
| €(43 251) |
|
|
|
|
|
|
|
|
|
| Basic loss per share (in EUR) | €(463) |
| €(379) |
| |
| |
| Diluted loss per share (in EUR) | €(463) |
| €(379) |
| |
| |
| CONSOLIDATED BALANCE SHEET (unaudited) | |||||
|
|
|
| As at December 31 | ||
|
|
|
| 2024 |
| 2023 |
| ASSETS |
|
|
|
|
|
| Non-current assets |
|
|
|
|
|
| Property, plant and equipment |
|
| 4 753 |
| 4 188 |
| Intangible assets |
|
| 50 381 |
| 46 608 |
| Right of use assets |
|
| 3 496 |
| 3 788 |
| Deferred tax asset |
|
| 76 |
| 56 |
| Other long-term receivables |
|
| 1 617 |
| 1 166 |
|
|
|
| |
| |
| Current assets |
|
|
|
|
|
| Inventory |
|
| 4 716 |
| 3 315 |
| Trade receivables |
|
| 3 382 |
| 2 758 |
| Other receivables |
|
| 2 774 |
| 3 212 |
| Other current assets |
|
| 1 656 |
| 1 318 |
| Financial assets |
|
| 51 369 |
| 36 138 |
| Cash and cash equivalents |
|
| 34 186 |
| 21 610 |
|
|
|
| |
| |
| Total assets |
|
| |
| |
|
|
|
|
|
|
|
| EQUITY AND LIABILITIES |
|
|
|
|
|
| Share capital and reserves |
|
|
|
|
|
| Share capital |
|
| 6 430 |
| 4 926 |
| Share premium |
|
| 314 345 |
| 246 127 |
| Share based payment reserve |
|
| 9 300 |
| 7 661 |
| Other comprehensive income |
|
| 914 |
| 137 |
| Retained loss |
|
| (217 735) |
| (160 829) |
| Total equity attributable to shareholders |
|
| |
| |
|
|
|
|
|
|
|
| LIABILITIES |
|
|
|
|
|
| Non-current liabilities |
|
|
|
|
|
| Financial debt |
|
| 18 725 |
| 8 373 |
| Lease liability |
|
| 2 562 |
| 3 116 |
| Pension liability |
|
| − |
| 9 |
| Provisions |
|
| 1 000 |
| 185 |
| Deferred tax liability |
|
| 19 |
| 9 |
| Contract liability |
|
| 472 |
| − |
| Other liabilities |
|
| 845 |
| − |
|
|
|
| |
| |
| Current liabilities |
|
|
|
|
|
| Financial debt |
|
| 248 |
| 364 |
| Lease liability |
|
| 1 118 |
| 851 |
| Trade payables |
|
| 9 505 |
| 8 108 |
| Current tax liability |
|
| 4 317 |
| 1 988 |
| Contract liability |
|
| 117 |
| − |
| Other liabilities |
|
| 6 224 |
| 3 132 |
|
|
|
| |
| |
| Total liabilities |
|
| |
| |
| Total equity and liabilities |
|
| |
| |
About Nyxoah
Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best-in-class outcomes for reducing OSA burden.
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 for FDA and U.S. commercialization approval.
For more information, please visit http://www.nyxoah.com/.
Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.
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; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; receipt of FDA approval; 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. Additionally, 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, 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
United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com
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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