Nyxoah מדווחת על תוצאותיה הכספיות והתפעוליות לרבעון הרביעי ולשנת הכספים 2024
מונט-סנט-גיברט, בלגיה, 13 במרץ 2025, (GLOBE NEWSWIRE) :
Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH) ("Nyxoah" או "החברה"), חברת טכנולוגיות רפואיות שמתמקדת בפיתוח ומסחור של פתרונות ושירותים חדשניים לדום נשימה בשינה (OSA) באמצעות נוירומודולציה, דיווחה היום על תוצאותיה הכספיות והתפעוליות לרבעון הרביעי ולשנת הכספים 2024.
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
"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 €0.6 million in the quarter. Due to this deferral, reported revenue was €1.3 million for the fourth quarter ending December 31, 2024, and €4.5 million for the full year. Had the Company not recorded deferred revenue for its disposable patches, total revenue for the fourth quarter would have €1.9 million, up 46% versus the third quarter of 2024. Likewise, revenue for the full year 2024 would have been €5.1 million, up 18% from €4.3 million in 2023. The increase in full year revenue was attributable to the Company’s commercialization of the Genio® system, primarily in Germany.
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 €1.1 million, or gross margin of 60%.
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 €1.7 million for the full year of 2023, for a gross profit of €2.7 million, or gross margin of 62%.
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 €26.7 million for the full year of 2023. The increase in research and development expenses was primarily driven by higher R&D activities and clinical expenses.
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 €28.5 million, versus €21.7 million for the full year of 2023. The increase in selling, general and administrative expenses was mainly due to an increase of costs to support the commercialization of Genio® system in Europe and scale up of the Company.
Operating Loss
Total operating loss for the fourth quarter and full year 2024 was €18.3 million and €58.8 million, respectively, versus €10.8 million and €45.1 million in the fourth quarter and full year 2023, respectively. This was driven by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities.
Cash Position
As of December 31, 2024, cash and financial assets totaled €85.6 million, compared to €57.7 million on December 31, 2023.
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.
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.
Contacts:
Nyxoah John Landry – CFO [email protected]
For Media United States FINN Partners – Glenn Silver [email protected]
Belgium/France Backstage Communication – Gunther De Backer [email protected]
International/Germany MC Services – Anne Hennecke [email protected]
Attachment
*** הידיעה מופצת בעולם על ידי חברת התקשורת הבינלאומית GlobeNewswire
חיים נוי, עיתונאי, עורך ראשי של סוכנות החדשות הבינ"ל IPA, לשעבר עורך ראשי של סוכנות הידיעות עתים, חבר תא מבקרי התיאטרון באגודת העיתונאים