מידע מוסדר
Nyxoah מדווחת על תוצאות כספיות ותפעוליות לרבעון השני
ה-FDA אישר את מערכת Genio® לשוק האמריקאי; החברה מתחילה בהשקה מסחרית
מונט-סנט-גיברט, בלגיה, 18 באוגוסט 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 תוצאות כספיות ותפעוליות לרבעון השני של 2025.
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 – GLOBE NEWSWIRE:
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
"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 35% and 40% of the night. The DREAM study measured position-specific outcomes and demonstrated a 66.6% median AHI reduction while patients slept in a supine position despite the fact that the number of airway obstructions can double in this position. This reduction compares favorably to the 71.0% reduction in AHI shown while patients slept in a non-supine position.
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 |
|
|
€ 850 |
|
€ 490 |
|
€ 1 508 |
|
€ 1 257 |
|||
|
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 |
|
|
€ (19 850) |
|
€ (13 307) |
|
€ (40 488) |
|
€ (25520) |
|||
|
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 |
|
|
€ (20 329) |
|
€ (12 683) |
|
€ (42 587) |
|
€ (24479) |
|||
|
Income taxes |
|
|
( 278) |
|
( 441) |
|
( 404) |
|
( 551) |
|||
|
Loss for the period |
|
|
€ (20 607) |
|
€ (13 124) |
|
€ (42 991) |
|
€ (25030) |
|||
|
|
|
|
|
|
|
|
|
|
|
|||
|
Loss attributable to equity holders |
|
|
€ (20 607) |
|
€ (13 124) |
|
€ (42 991) |
|
€ (25030) |
|||
|
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 |
|
|
€ (20 375) |
|
€ (13 206) |
|
€ (42 761) |
|
€ (25052) |
|||
|
Loss attributable to equity holders |
|
|
€ (20 375) |
|
€ (13 206) |
|
€ (42 761) |
|
€ (25052) |
|||
|
|
|
|
|
|
|
|
|
|
|
|||
|
Basic Loss Per Share (in EUR) |
|
|
€ (0.551) |
|
€ (0.428) |
|
€ (1.149) |
|
€ (0.843) |
|||
|
Diluted Loss Per Share (in EUR) |
|
|
€ (0.551) |
|
€ (0.428) |
|
€ (1.149) |
|
€ (0.843) |
|||
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)
|
|
|
|
|
As at |
||
|
|
|
|
|
June 30 |
|
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 |
|
|
|
|
|
€ 61 356 |
|
€ 60 323 |
|
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 |
|
|
|
|
|
€ 55 114 |
|
€ 98 083 |
|
Total assets |
|
|
|
€ 116 470 |
|
€ 158 406 |
|
|
|
|
|
|
|
|
|
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 |
|
|
|
€ 73 397 |
|
€ 113 254 |
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
€ 22 127 |
|
€ 23 623 |
|
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 |
|
|
|
|
|
€ 20 946 |
|
€ 21 529 |
|
Total liabilities |
|
|
|
€ 43 073 |
|
€ 45 152 |
|
Total equity and liabilities |
|
|
|
€ 116 470 |
|
€ 158 406 |
Revenue
Revenue was €1.3 million for the second quarter ending June 30, 2025, compared to €0.8 million for the second quarter ending June 30, 2024, representing a 74% year over year increase.
Cost of Goods Sold
Cost of goods sold was €490,000 for the second quarter ending June 30, 2025, representing a gross profit of €0.9 million, or gross margin of 63.4%. This compares to cost of goods sold of €281,000 in the second quarter ending June 30, 2024, for a gross profit of €0.5 million, or gross margin of 63.6%.
Research and Development
For the second quarter ending June 30, 2025, research and development (“R&D”) expenses were €10.0 million, versus €7.5 million for the second quarter ending June 30, 2024. The increase in research and development expenses was primarily due to higher R&D activities offset by a decrease in clinical study expenses.
Selling, General and Administrative
For the second quarter ending June 30, 2025, selling, general and administrative expenses were €10.7 million, versus €6.4 million for the second quarter ending June 30, 2024. The increase in selling, general and administrative expenses was primarily due to an increase in costs to support the commercialization of Genio system, including the Company’s overall scale-up preparations for the commercialization of Genio system in the US in connection with the receipt of FDA approval.
Operating Loss
Total operating loss for the second quarter ending June 30, 2025 was €19.9 million, versus €13.3 million in the second quarter 2024, respectively. This was driven by an increase in selling, general and administrative expenses to support commercialization of the Genio system, including the Company’s overall scale-up preparations for the commercialization of Genio system in the US in connection with the receipt of FDA approval, and increased R&D activities offset by a decrease in clinical study expenses.
Cash Position
As of June 30, 2025, cash, cash equivalents and financial assets totaled €43.0 million, compared to €63.0 million at the end of March 31, 2025. The Company also has a term debt facility with €27.5 million of remaining availability which can be drawn down in two equal tranches subject to revenue and other financial milestones.
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:
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