Nyxoah Reports First Quarter Financial and Operating Results
- FDA Approvable Letter received, indicating substantial compliance with regulatory requirements
- Successfully completed FDA validation requirements with final site inspection in progress
- Maintained healthy gross margin of 61.8%
- Strong cash position of €63.0M to support operations
- Previous successful FDA site inspection with no deficiencies
- Revenue declined to €1.1M from €1.2M in Q1 2024
- Operating loss increased significantly to €20.6M from €12.2M in Q1 2024
- Cash position decreased from €85.6M to €63.0M during the quarter
- Net loss increased to €22.4M from €11.9M in Q1 2024
Insights
Nyxoah nears FDA approval for its Genio sleep apnea device while managing increased operating losses amid US commercialization preparations.
Nyxoah has reached a critical milestone in its regulatory journey with the FDA issuing an Approvable Letter for the Genio® system, signaling that the company has substantially met the requirements of the Federal Food, Drug and Cosmetic Act. This represents the penultimate step in the PMA approval process, with only a final manufacturing site inspection remaining. The company has already successfully completed the required validation work, and the manufacturing site previously passed an FDA inspection with no deficiencies—both positive indicators for potential approval in Q2 2025.
The regulatory progress demonstrates that the FDA has accepted Nyxoah's clinical data validating both the safety and effectiveness of the Genio® system for treating Obstructive Sleep Apnea (OSA). This is particularly significant in the competitive neuromodulation market for OSA treatment. The company's confidence in imminent approval is driving their accelerated preparations for US market entry.
However, these commercialization preparations are reflected in the financial results. The company reported revenue of €1.1 million for Q1 2025, representing a slight decline from €1.2 million in Q1 2024. More significantly, operating losses widened to €20.6 million from €12.2 million year-over-year, primarily driven by a 107% increase in selling, general and administrative expenses (€12.4 million vs €6.0 million) as the company scales up for anticipated US commercialization. Research and development expenses also increased by 25% to €9.0 million.
The company's cash position has declined significantly from €85.6 million at the end of 2024 to €63.0 million at the end of Q1 2025—a €22.6 million reduction in just one quarter. This accelerated cash burn aligns with the company's strategic push toward US market entry but warrants careful monitoring of the runway. At the current burn rate, without additional financing, Nyxoah would have approximately 7-9 months of operating capital remaining.
The international launch of the Genio® 2.1 patient software upgrade indicates continued product development and lifecycle management, which is important for maintaining competitiveness in existing markets while preparing to enter the substantial US market. The gross margin remains relatively stable at 61.8%, only slightly below the 62.7% reported for Q1 2024, suggesting the company is maintaining production efficiency despite scaling challenges.
Nyxoah's regulatory progress is promising, but worsening financials with rapid cash burn merit caution despite near-term catalyst potential.
Examining Nyxoah's Q1 2025 financial performance reveals some concerning trends beneath the positive regulatory developments. The company's revenue decreased by 12.9% year-over-year to €1.064 million from €1.221 million, indicating challenges in current commercial markets. While gross margin remained relatively stable at 61.8% compared to 62.7% in Q1 2024, the operating metrics deteriorated substantially.
The most alarming figure is the 69% increase in operating loss to €20.639 million from €12.213 million in Q1 2024. This widening loss stems from significant increases in both R&D expenses (+24.9% to €8.989 million) and SG&A expenses (+107.5% to €12.392 million). The company attributes these increases to preparations for US commercialization and ongoing clinical activities, which is strategically sound but financially demanding.
The balance sheet shows a rapid deterioration in cash position, with cash, cash equivalents, and financial assets decreasing by €22.6 million in just one quarter to €63.0 million. This represents a burn rate of approximately €7.5 million per month, which would give Nyxoah roughly 8 months of runway at current spending levels. This accelerated cash consumption raises questions about potential future financing needs, especially if FDA approval or commercial traction takes longer than anticipated.
The loss per share increased to €0.598 from €0.415 year-over-year, a 44% deterioration that reflects the company's expanding losses and indicates further shareholder dilution may be necessary before reaching profitability.
Total liabilities decreased slightly to €43.060 million from €45.152 million at year-end 2024, with relatively stable financial debt levels, suggesting the company is not taking on additional leverage to fund operations. However, the substantial increase in comprehensive loss to €22.386 million from €11.846 million year-over-year indicates the significant scaling costs the company is incurring.
While the pending FDA approval represents a major potential catalyst, investors should carefully weigh the rapidly deteriorating financial metrics against the uncertain timeline and magnitude of commercial success in the US market. The current trajectory suggests Nyxoah will need additional capital in the near term, possibly coinciding with or shortly after potential FDA approval, which could create a complex financial scenario depending on market conditions at that time.
REGULATED INFORMATION
Nyxoah Reports First Quarter Financial and Operating Results
Company On Track for Anticipated PMA Approval in the Second Quarter of 2025
Successfully Completed FDA Validation Requirements, Final Site Inspection in Progress
Mont-Saint-Guibert, Belgium – May 14, 2025, 7am CET / 1am 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 first quarter of 2025.
Recent Financial and Operating Highlights
- Received an FDA Approvable Letter indicating the FDA will approve the Company’s PMA application for its Genio® system subject to satisfactory completion of a manufacturing facilities, methods and controls review
- Successfully completed FDA validation requirements, final site inspection in progress at the U.S. contract manufacturing site
- Revenue for the first quarter of 2025 was
€1.1 million , compared to€1.2 million in the first quarter of 2024 - Launched Genio® 2.1 patient software upgrade in international commercial markets
- Cash, cash equivalents and financial assets were
€63.0 million at March 31, 2025, compared to€85.6 million at the end of 2024
"We are excited that we are in the final stage of the FDA review process of our Genio® system in the United States," commented Olivier Taelman, Nyxoah's Chief Executive Officer. "The FDA Approvable Letter we received previously confirms that our application substantially meets the requirements of the Federal Food, Drug and Cosmetic Act, including biocompatibility and acceptance of our clinical data demonstrating the safety and effectiveness of the Genio® system. We have successfully completed the final process validation requested by the FDA. We understand that the last step toward FDA approval is an on-site inspection at the U.S. manufacturing site which we expect to be completed shortly. As part of the PMA process, this site has already successfully passed an on-site inspection with no deficiencies, which gives us confidence in completing this regulatory step. We continue to anticipate that our application could potentially be approved in the second quarter of 2025."
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)
| For the three months ended March 31 | |||||
| 2025 | 2024 | ||||
| Revenue | |||||
| Cost of goods sold | ( 406) | ( 455) | |||
| Gross profit | |||||
| Research and Development Expense | (8 989) | (7 199) | |||
| Selling, General and Administrative Expense | (12 392) | (5 972) | |||
| Other income/(expense) | 84 | 192 | |||
| Operating loss for the period | |||||
| Financial income | 2 622 | 1 408 | |||
| Financial expense | (4 242) | ( 991) | |||
| Loss for the period before taxes | |||||
| Income taxes | ( 125) | ( 110) | |||
| 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 | ( 2) | 60 | |||
| 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 | ||||||
| March 31 2025 | December 31 2024 | |||||
| ASSETS | ||||||
| Non-current assets | ||||||
| Property, plant and equipment | 4 696 | 4 753 | ||||
| Intangible assets | 50 977 | 50 381 | ||||
| Right of use assets | 3 152 | 3 496 | ||||
| Deferred tax asset | 78 | 76 | ||||
| Other long-term receivables | 1 790 | 1 617 | ||||
| Current assets | ||||||
| Inventory | 4 981 | 4 716 | ||||
| Trade receivables | 2 604 | 3 382 | ||||
| Other receivables | 3 128 | 2 774 | ||||
| Other current assets | 1 450 | 1 656 | ||||
| Financial assets | 40 653 | 51 369 | ||||
| Cash and cash equivalents | 22 394 | 34 186 | ||||
| Total assets | ||||||
| EQUITY AND LIABILITIES | ||||||
| Share capital and reserves | ||||||
| Share capital | 6 430 | 6 430 | ||||
| Share premium | 314 345 | 314 345 | ||||
| Share based payment reserve | 11 256 | 9 300 | ||||
| Other comprehensive income | 912 | 914 | ||||
| Retained loss | (240 100) | (217 735) | ||||
| Total equity attributable to shareholders | ||||||
| LIABILITIES | ||||||
| Non-current liabilities | ||||||
| Financial debt | 18 519 | 18 725 | ||||
| Lease liability | 2 316 | 2 562 | ||||
| Provisions | 548 | 1 000 | ||||
| Deferred tax liability | 27 | 19 | ||||
| Contract liabilities | 277 | 472 | ||||
| Other liabilities | 401 | 845 | ||||
| Current liabilities | ||||||
| Financial debt | 244 | 248 | ||||
| Lease liability | 1 010 | 1 118 | ||||
| Trade payables | 9 316 | 9 505 | ||||
| Current tax liability | 4 300 | 4 317 | ||||
| Contract liability | 368 | 117 | ||||
| Other liabilities | 5 734 | 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 first quarter ending March 31, 2025, research and development expenses were
Selling, General and Administrative
For the first quarter ending March 31, 2025, selling, general and administrative expenses were
Operating Loss
Total operating loss for the first quarter ending March 31, 2025 was
Cash Position
As of March 31, 2025, cash, cash equivalents and financial assets totaled
First Quarter 2025
Nyxoah’s financial report for the first quarter of 2025, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).
Progress Toward FDA PMA Approval
On March 26, 2025, Nyxoah announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system. The Approvable Letter means that Nyxoah's application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA's PMA implementing regulations.
The FDA has accepted all other data provided with the PMA submission, including most importantly that the clinical study demonstrates the safety and effectiveness of the Genio® system. Nyxoah has successfully completed the validation work requested by the FDA for the manufacturing process used for a component of the Genio system at the U.S. manufacturing site. The Company submitted the required documentation to the FDA, which has reviewed this validation work and confirmed they have no further questions. We believe that the last step before full PMA approval is an on-site FDA inspection of the U.S. manufacturing site which we expect to be completed shortly. As part of the PMA process, this site already passed an on-site inspection with no deficiencies, giving the Company confidence in completing this regulatory step. Nyxoah anticipates that its application could potentially be approved in the second quarter of 2025.
Conference call and webcast presentation
Company management will host a conference call to discuss financial results on Wednesday, May 14, 2025, beginning at 2:00pm 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 Q1 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: Nyxoah's Q1 2025 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 Obstructive Sleep Apnea (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.
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; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; 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, 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
FAQ
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