Full Press Release Details
REGULATED INFORMATION
Nyxoah Reports First Quarter Financial and Operating
Company On Track for Anticipated
PMA Approval in the Second Quarter of 2025
Successfully Completed FDA Validation Requirements,
Final Site Inspection in Progress
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
"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)
| For the three months ended March 31 | ||||||||
| 2025 | 2024 | |||||||
| Revenue | 1 064 | 1 221 | ||||||
| Cost of goods sold | (406 | ) | (455 | ) | ||||
| Gross profit | 658 | 766 | ||||||
| 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 | (20 639 | ) | (12 213 | ) | ||||
| Financial income | 2 622 | 1 408 | ||||||
| Financial expense | (4 242 | ) | (991 | ) | ||||
| Loss for the period before taxes | (22 259 | ) | (11 796 | ) | ||||
| Income taxes | (125 | ) | (110 | ) | ||||
| Loss for the period | (22 384 | ) | (11 906 | ) | ||||
| Loss attributable to equity holders | (22 384 | ) | (11 906 | ) | ||||
| 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 | (22 386 | ) | (11 846 | ) | ||||
| Loss attributable to equity holders | (22 386 | ) | (11 846 | ) | ||||
| Basic Loss Per Share (in EUR) | (0.598 | ) | (0.415 | ) | ||||
| Diluted Loss Per Share (in EUR) | (0.598 | ) | (0.415 | ) |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
| 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 | ||||||
| 60 693 | 60 323 | |||||||
| 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 | ||||||
| 75 210 | 98 083 | |||||||
| Total assets | 135 903 | 158 406 | ||||||
| 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 | 92 843 | 113 254 | ||||||
| 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 | ||||||
| 22 088 | 23 623 | |||||||
| 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 | ||||||
| 20 972 | 21 529 | |||||||
| Total liabilities | 43 060 | 45 152 | ||||||
| Total equity and liabilities | 135 903 | 158 406 |
Revenue was 1.1 million for the first quarter
ending March 31, 2025, compared to 1.2 million for the first quarter ending March 31, 2024.
of goods sold was 406,000 for the first quarter ending March 31, 2025, representing a gross profit of 0.7 million,
or gross margin of 61.8%. This compares to cost of goods sold of 455,000 in the first quarter ending March 31, 2024, for a
gross profit of 0.8 million, or gross margin of 62.7%.
Research and Development
the first quarter ending March 31, 2025, research and development expenses were 9.0 million, versus 7.2 million
for the first quarter ending March 31, 2024. The increase in research and development expenses was primarily due to higher R&D
activities and clinical study expenses.
Selling, General and Administrative
the first quarter ending March 31, 2025, selling, general and administrative expenses were 12.4 million, versus 6.0
million for the first quarter ending March 31, 2024. The increase in selling, general and administrative expenses was primarily
due to an increase in costs to support the commercialization of Genio system, the Company's overall scale-up preparations
for the upcoming commercialization of Genio system in the US upon receipt of FDA approval.
operating loss for the first quarter ending March 31, 2025 was 20.6 million, versus 12.2 million in the first
quarter 2024, respectively. This was driven by an increase in selling, general and administrative expenses to support commercialization
of the Genio system, the Company's overall scale-up preparations for the upcoming commercialization of Genio system
in the US upon receipt of FDA approval and increased R&D activities and clinical study expenses.
As of March 31, 2025, cash, cash equivalents
and financial assets totaled 63.0 million, compared to 85.6 million at the end of 2024.
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.
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
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.
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.
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.
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