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.
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
- 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, representing 74% 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 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: 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.
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