Full Press Release Details
REGULATED INFORMATION
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
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
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 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
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
Research and Development
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
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.
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.
As of December 31, 2024, cash and financial assets
totaled 85.6 million, compared to 57.7 million on December 31, 2023.
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.
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE
| For the three months ended December 31, | For the twelve months ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue | 1 263 | 1 824 | 4 521 | 4 348 | ||||||||||||
| Cost of goods sold | (335 | ) | (726 | ) | (1 552 | ) | (1 656 | ) | ||||||||
| Gross profit | 928 | 1 098 | 2 969 | 2 692 | ||||||||||||
| Research and Development Expense | (11 752 | ) | (7 321 | ) | (34 325 | ) | (26 651 | ) | ||||||||
| Selling, General and Administrative Expense | (8 065) | (4 893 | ) | (28 461 | ) | (21 687 | ) | |||||||||
| Other income/(expense) | 578 | 279 | 1 008 | 544 | ||||||||||||
| Operating loss for the period | (18 311 | ) | (10 837 | ) | (58 809 | ) | (45 102 | ) | ||||||||
| Financial income | 2 832 | 582 | 7 447 | 4 174 | ||||||||||||
| Financial expense | 410 | (964 | ) | (5 070 | ) | (3 729 | ) | |||||||||
| Loss for the period before taxes | (15 069 | ) | (11 219 | ) | (56 432 | ) | (44 657 | ) | ||||||||
| Income taxes | (2 080 | ) | 326 | (2 804 | ) | 1 445 | ||||||||||
| Loss for the period | (17 149 | ) | (10 893 | ) | (59 236 | ) | (43 212 | ) | ||||||||
| Loss attributable to equity holders | (17 149 | ) | (10 893 | ) | (59 236 | ) | (43 212 | ) | ||||||||
| Other comprehensive income/(loss) | ||||||||||||||||
| Items that may not be subsequently reclassified to profit or loss (net of tax) | ||||||||||||||||
| Remeasurements of post-employment benefit obligations, net of tax | 11 | 81 | 11 | 81 | ||||||||||||
| Items that may be subsequently reclassified to profit or loss (net of tax) | ||||||||||||||||
| Currency translation differences | 545 | (32 | ) | 766 | (120 | ) | ||||||||||
| Total other comprehensive income/(loss) | 556 | (39 | ) | 777 | (39 | ) | ||||||||||
| Total comprehensive loss for the year, net of tax | (16 151 | ) | (10 844 | ) | (58 459 | ) | (43 251 | ) | ||||||||
| Loss attributable to equity holders | (16 151 | ) | (10 844 | ) | (58 459 | ) | (43 251 | ) | ||||||||
| Basic loss per share (in EUR) | (463 | ) | (379 | ) | (1 809 | ) | (1 545 | ) | ||||||||
| Diluted loss per share (in EUR) | (463 | ) | (379 | ) | (1 809 | ) | (1 545 | ) |
CONSOLIDATED BALANCE SHEET (unaudited)
| As at December 31 | ||||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Property, plant and equipment | 4 753 | 4 188 | ||||||
| Intangible assets | 50 381 | 46 608 | ||||||
| Right of use assets | 3 496 | 3 788 | ||||||
| Deferred tax asset | 76 | 56 | ||||||
| Other long-term receivables | 1 617 | 1 166 | ||||||
| 60 323 | 55 806 | |||||||
| Current assets | ||||||||
| Inventory | 4 716 | 3 315 | ||||||
| Trade receivables | 3 382 | 2 758 | ||||||
| Other receivables | 2 774 | 3 212 | ||||||
| Other current assets | 1 656 | 1 318 | ||||||
| Financial assets | 51 369 | 36 138 | ||||||
| Cash and cash equivalents | 34 186 | 21 610 | ||||||
| 98 083 | 68 351 | |||||||
| Total assets | 158 406 | 124 157 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Share capital and reserves | ||||||||
| Share capital | 6 430 | 4 926 | ||||||
| Share premium | 314 345 | 246 127 | ||||||
| Share based payment reserve | 9 300 | 7 661 | ||||||
| Other comprehensive income | 914 | 137 | ||||||
| Retained loss | (217 735 | ) | (160 829 | ) | ||||
| Total equity attributable to shareholders | 113 254 | 98 022 | ||||||
| LIABILITIES | ||||||||
| Non-current liabilities | ||||||||
| Financial debt | 18 725 | 8 373 | ||||||
| Lease liability | 2 562 | 3 116 | ||||||
| Pension liability | - | 9 | ||||||
| Provisions | 1 000 | 185 | ||||||
| Deferred tax liability | 19 | 9 | ||||||
| Contract liability | 472 | - | ||||||
| Other liabilities | 845 | - | ||||||
| 23 623 | 11 692 | |||||||
| Current liabilities | ||||||||
| Financial debt | 248 | 364 | ||||||
| Lease liability | 1 118 | 851 | ||||||
| Trade payables | 9 505 | 8 108 | ||||||
| Current tax liability | 4 317 | 1 988 | ||||||
| Contract liability | 117 | - | ||||||
| Other liabilities | 6 224 | 3 132 | ||||||
| 21 529 | 14 443 | |||||||
| Total liabilities | 45 152 | 26 135 | ||||||
| Total equity and liabilities | 158 406 | 124 157 |
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
For more information, please visit http://www.nyxoah.com/.
- 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; the utility of clinical data in potentially obtaining FDA approval of the Genio system; receipt of FDA approval; 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, 2023, filed with the Securities and Exchange
Commission ("SEC") on March 20, 2024, 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