Full Press Release Details
REGULATED INFORMATION
Nyxoah Reports Fourth Quarter and Full Year
2022 Financial and Operating Results
Completed all 115 implants in the DREAM U.S.
Belgium - March 22, 2023 09:05pm CET / 4:05pm ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah"
or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions to
treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the fourth quarter and full year 2022.
Recent Financial and Operating Highlights
"With all 115 implants completed
in the DREAM study and our first PMA module submitted, we achieved key milestones towards U.S. FDA approval. Our attention now focuses
on patient follow up. With the clearance of our second manufacturing site, we have strengthened our supply chain to meet increasing demand,"
commented Olivier Taelman, Nyxoah Chief Executive Officer.
Mr. Taelman continued, "Commercially
in Europe, we are excited to see the continued demand growth for Genio in Germany. Our growing experience with CCC patients in Europe,
driven by our expanded label, reinforces our confidence in our ongoing U.S. ACCCESS study."
For the trial to be successful, of the 115 patients, at least 63% of patients need to be AHI and ODI responders at the 12-month
REGULATED INFORMATION
Fourth Quarter and Full Year 2022 Results
UNAUDITED CONDENSED CONSOLIDATED
FINANCIAL INFORMATION - CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS FOR THE THREE MONTHS AND YEARS ENDED DECEMBER
31, 2022 AND DECEMBER 31, 2021 (in thousands)
| For the three months ended December 31, | For the year ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | 1,307 | 295 | 3,084 | 852 | ||||||||||||
| Cost of goods sold | (465 | ) | (105 | ) | (1,150 | ) | (303 | ) | ||||||||
| Gross profit | 842 | 190 | 1,934 | 549 | ||||||||||||
| Research and Development Expense | (4,575 | ) | (3,335 | ) | (15,861 | ) | (12,344 | ) | ||||||||
| Selling, General and Administrative Expense | (5,363 | ) | (3,937 | ) | (18,855 | ) | (14,712 | ) | ||||||||
| Other income/(expense) | 46 | 539 | 283 | 265 | ||||||||||||
| Operating loss for the period | (9,050 | ) | (6,543 | ) | (32,499 | ) | (26,242 | ) | ||||||||
| Financial income | (4,609 | ) | 3,603 | 6,763 | 3,675 | |||||||||||
| Financial expense | 1,153 | (588 | ) | (4,320 | ) | (2,072 | ) | |||||||||
| Loss for the period before taxes | (12,506 | ) | (3,528 | ) | (30,056 | ) | (24,639 | ) | ||||||||
| Income taxes | (790 | ) | (2,720 | ) | (1,169 | ) | (2,980 | ) | ||||||||
| Loss for the period | (13,296 | ) | (6,248 | ) | (31,225 | ) | (27,619 | ) | ||||||||
| Loss attributable to equity holders | (13,296 | ) | (6,248 | ) | (31,225 | ) | (27,619 | ) | ||||||||
| 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 | 70 | (68 | ) | 70 | (68 | ) | ||||||||||
| Items that may be subsequently reclassified to profit or loss (net of tax) | ||||||||||||||||
| Currency translation differences | (82 | ) | (17 | ) | (96 | ) | 121 | |||||||||
| Total other comprehensive income/(loss) | (12 | ) | (85 | ) | (26 | ) | 53 | |||||||||
| Total comprehensive loss for the year, net of tax | (13,308 | ) | (6,333 | ) | (31,251 | ) | (27,566 | ) | ||||||||
| Loss attributable to equity holders | (13,308 | ) | (6,333 | ) | (31,251 | ) | (27,566 | ) | ||||||||
| Basic loss per share (in EUR) | (514 | ) | (238 | ) | (1,209 | ) | (1,161 | ) | ||||||||
| Diluted loss per share (in EUR) | (514 | ) | (238 | ) | (1,209 | ) | (1,161 | ) |
REGULATED INFORMATION
UNAUDITED CONDENSED CONSOLIDATED
FINANCIAL INFORMATION - CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS OF DECEMBER 31, 2022 AND
DECEMBER 31, 2021 (in thousands)
| As of December 31, | ||||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Property, plant and equipment | 2,460 | 2,020 | ||||||
| Intangible assets | 39,972 | 25,322 | ||||||
| Right of use assets | 3,159 | 3,218 | ||||||
| Deferred tax asset | 47 | 46 | ||||||
| Other long-term receivables | 173 | 164 | ||||||
| 45,811 | 30,770 | |||||||
| Current assets | ||||||||
| Inventory | 882 | 346 | ||||||
| Trade receivables | 1,463 | 226 | ||||||
| Other receivables | 1,775 | 2,286 | ||||||
| Other current assets | 1,284 | 1,693 | ||||||
| Financial assets | 76,968 | - | ||||||
| Cash and cash equivalents | 17,888 | 135,509 | ||||||
| 100,260 | 140,060 | |||||||
| Total assets | 146,071 | 170,830 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Capital and reserves | ||||||||
| Capital | 4,440 | 4,427 | ||||||
| Share premium | 228,275 | 228,033 | ||||||
| Share based payment reserve | 5,645 | 3,127 | ||||||
| Other comprehensive income | 176 | 202 | ||||||
| Retained loss | (118,212 | ) | (87,167 | ) | ||||
| Total equity attributable to shareholders | 120,324 | 148,622 | ||||||
| LIABILITIES | ||||||||
| Non-current liabilities | ||||||||
| Financial debt | 8,189 | 7,802 | ||||||
| Lease liability | 2,586 | 2,737 | ||||||
| Pension liability | - | 80 | ||||||
| Provisions | 59 | 12 | ||||||
| Deferred tax liability | - | 5 | ||||||
| 10,834 | 10,636 | |||||||
| Current liabilities | ||||||||
| Financial debt | 388 | 554 | ||||||
| Lease liability | 719 | 582 | ||||||
| Trade payables | 4,985 | 3,995 | ||||||
| Current tax liability | 3,654 | 2,808 | ||||||
| Other payables | 5,167 | 3,633 | ||||||
| 14,913 | 11,572 | |||||||
| Total liabilities | 25,747 | 22,208 | ||||||
| Total equity and liabilities | 146,071 | 170,830 |
REGULATED INFORMATION
Revenue was 1.3 million for the fourth quarter
ending December 31, 2022, compared to 295,000 for the fourth quarter ending December 31, 2021. Revenue for the full year
of 2022 was 3.1 million, compared to 0.9 million for the full year of 2021. The increase in revenue was attributable to the
Company's commercialization of the Genio system, primarily in Germany.
Cost of goods sold was 465,000 for the three
months ending December 31, 2022, representing a gross profit of 0.8 million, or gross margin of 64.4%. This compares to total
cost of goods sold of 105,000 in the fourth quarter of 2021, for a gross profit of 190,000, or gross margin of 64.4%.
For the full year ending December 31, 2022,
total cost of goods sold was 1.2 million, representing a gross profit of 1 million, or gross margin of 62.7%. This compares
to total cost of goods sold of 303,000 for the full year of 2021, for a gross profit of 0.5 million or gross margin of 64.4%.
Research and Development Expenses
Research and development expenses were 4.6
million for the three months ending December 31, 2022, versus 3.3 million for the prior year period, reflecting the Company's
investments in the development of next generation versions of the Genio system as well as ongoing clinical studies, most notably
REGULATED INFORMATION
For the full year ending December 31, 2022,
research and development expenses were 15.9 million, versus 12.3 million for the full year of 2021.
Selling, General and Administrative Expenses
Selling, general and administrative expenses rose
to 5.4 million for the fourth quarter of 2022, up from 3.9 million in the fourth quarter of 2021. This was due primarily to
increased commercial efforts in Germany and other European markets, as well as investments in Nyxoah's corporate infrastructure.
The Company expects to continue adding headcount across the organization ahead of the U.S. commercial launch.
For the full year ending December 31, 2022,
selling, general and administrative expenses were 18.9 million, up from 14.7 million for the full year 2021 due to increased
commercial efforts in Germany and investments in Nyxoah's corporate infrastructure.
Total operating loss for the fourth quarter and
full year 2022 was 9.1 million and 32.5 million, respectively, versus 6.5 million and 26.2 million in the fourth
quarter and full year 2021, 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, 2022, cash and financial
assets totaled 95 million, compared to 135.5 million on December 31, 2021. Total cash burn was approximately 3.4
million per month during 2022.
Full year report 2022
Nyxoah's financial report for the full
year of 2022, including details of the audited consolidated results, are available on the investor page of Nyxoah's website
Conference call and webcast presentation
Nyxoah will conduct a conference call open to
the public today at 10:30pm CET / 4:30pm ET, which will also be webcast. To participate in the conference call, please access the following
link to register for a dial-in number: https://register.vevent.com/register/BIfc3a52c9352e4e42958e9d816245b3b9
question-and-answer session will follow the presentation of the results. To access the live webcast, go to https://investors.nyxoah.com/events.
The archived webcast will be available for replay shortly after the close of the call.
REGULATED INFORMATION
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 is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.
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; 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,
2021, filed with the Securities and Exchange Commission ("SEC") on March 24, 2022, 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