Full Press Release Details
Reports Third Quarter 2023 Financial and Operating Results
with ResMed Germany to increase OSA awareness and therapy penetration
Belgium - November 8, 2023 10:05pm 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 third quarter of 2023.
Financial and Operating Highlights
is entering one of the most exciting times in the company's history. We will report data from our DREAM U.S. pivotal trial early
next year, shortly thereafter complete our modular PMA submission, and expect FDA approval late 2024," commented Olivier Taelman,
Chief Executive Officer. "Hypoglossal nerve stimulation (HGNS) remains highly underpenetrated and guiding patients through their
OSA journey is key to unlocking the market's potential. Our agreement with ResMed Germany, which takes ResMed from a valued investor
to commercial partner, creates a continuum of care that directs patients towards the appropriate treatment, resulting in greater therapy
STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
| For the three months ended September 30 | For the nine months ended September 30 | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue | 976 | 182 | 2,524 | 1,777 | ||||||||||||
| Cost of goods sold | (336 | ) | (63 | ) | (930 | ) | (685 | ) | ||||||||
| Gross profit | 640 | 119 | 1,594 | 1,092 | ||||||||||||
| Research and Development Expense | (6,568 | ) | (4,221 | ) | (19,330 | ) | (11,286 | ) | ||||||||
| Selling, General and Administrative Expense | (5,058 | ) | (4,763 | ) | (16,794 | ) | (13,492 | ) | ||||||||
| Other income/(expense) | - | 87 | 265 | 237 | ||||||||||||
| Operating loss for the period | (10,986 | ) | (8,778 | ) | (34,265 | ) | (23,449 | ) | ||||||||
| Financial income | 2,178 | 5,127 | 3,592 | 11,372 | ||||||||||||
| Financial expense | (1,033 | ) | (2,524 | ) | (2 765) | (5,473 | ) | |||||||||
| Loss for the period before taxes | (9,841 | ) | (6,175 | ) | (33,438 | ) | (17,550 | ) | ||||||||
| Income taxes | 2,229 | (65 | ) | 1,119 | (379 | ) | ||||||||||
| Loss for the period | (7,612 | ) | (6,240 | ) | (32,319 | ) | (17,929 | ) | ||||||||
| Loss attributable to equity holders | (7,612 | ) | (6,240 | ) | (32,319 | ) | (17,929 | ) | ||||||||
| Other comprehensive loss | ||||||||||||||||
| Items that may be subsequently reclassified to profit or loss (net of tax) | ||||||||||||||||
| Currency translation differences | (10 | ) | 100 | (88 | ) | (14 | ) | |||||||||
| Total comprehensive loss for the year, net of tax | (7,622 | ) | (6,140 | ) | (32,407 | ) | (17,943 | ) | ||||||||
| Loss attributable to equity holders | (7,622 | ) | (6,140 | ) | (32,407 | ) | (17,943 | ) | ||||||||
| Basic Loss Per Share (in EUR) | (0.266 | ) | (0.242 | ) | (1.166 | ) | (0.695 | ) | ||||||||
| Diluted Loss Per Share (in EUR) | (0.266 | ) | (0.242 | ) | (1.166 | ) | (0.695 | ) |
STATEMENT OF FINANCIAL POSITION (unaudited)
| As at | ||||||||
| September 30 2023 | December 31 2022 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Property, plant and equipment | 4,328 | 2,460 | ||||||
| Intangible assets | 45,720 | 39,972 | ||||||
| Right of use assets | 3,602 | 3,159 | ||||||
| Deferred tax asset | 47 | 47 | ||||||
| Other long-term receivables | 668 | 173 | ||||||
| 54,365 | 45,811 | |||||||
| Current assets | ||||||||
| Inventory | 1,709 | 882 | ||||||
| Trade receivables | 1,918 | 1,463 | ||||||
| Other receivables | 2,437 | 1,775 | ||||||
| Other current assets | 1,683 | 1,284 | ||||||
| Financial assets | 59,239 | 76,968 | ||||||
| Cash and cash equivalents | 13,250 | 17,888 | ||||||
| 80,236 | 100,260 | |||||||
| Total assets | 134,601 | 146,071 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Capital and reserves | ||||||||
| Capital | 4,926 | 4,440 | ||||||
| Share premium | 246,130 | 228,275 | ||||||
| Share based payment reserve | 7,468 | 5,645 | ||||||
| Other comprehensive income | 88 | 176 | ||||||
| Retained loss | (150,070 | ) | (118,212 | ) | ||||
| Total equity attributable to shareholders | 108,542 | 120,324 | ||||||
| LIABILITIES | ||||||||
| Non-current liabilities | ||||||||
| Financial debt | 8,407 | 8,189 | ||||||
| Lease liability | 2,990 | 2,586 | ||||||
| Pension liability | 75 | - | ||||||
| Provisions | 125 | 59 | ||||||
| Deferred tax liability | 6 | - | ||||||
| 11,603 | 10,834 | |||||||
| Current liabilities | ||||||||
| Financial debt | 769 | 388 | ||||||
| Lease liability | 788 | 719 | ||||||
| Trade payables | 4,480 | 4,985 | ||||||
| Current tax liability | 2,367 | 3,654 | ||||||
| Other payables | 6,052 | 5,167 | ||||||
| 14,456 | 14,913 | |||||||
| Total liabilities | 26,059 | 25,747 | ||||||
| Total equity and liabilities | 134,601 | 146,071 |
was 1.0 million for the third quarter ending September 30, 2023, compared to 182,000 for third quarter ending September 30,
of goods sold was 336,000 for the three months ending September 30, 2023, representing a gross profit of 640,000, or
gross margin of 66.0%. This compares to total cost of goods sold of 63,000 in the third quarter ending September 30, 2022, for
a gross profit of 119,000, or gross margin of 65.4%.
and Development Expenses
and development expenses were 6.6 million for the three months ending September 30, 2023, versus 4.2 million for the
prior year period, driven by an acceleration in clinical activities, notably the start of the ACCCESS study.
General and Administrative Expenses
general and administrative expenses rose to 5.1 million for the third quarter of 2023, up from 4.8 million in the third quarter
of 2022. 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.
operating loss for the third quarter 2023 was 11.0 million versus 8.8 million in the third quarter of 2022. This was driven
by the acceleration in the Company's R&D spending, as well as ongoing commercial and clinical activities.
of September 30, 2023, cash and financial assets totaled 72.5 million, compared to 94.9 million on December 31, 2022.
Total cash burn was approximately 4.0 million per month during the third quarter of 2023.
financial report for the third quarter 2023, including details of the consolidated results, are available on the investor page of
Nyxoah's website (https://investors.nyxoah.com/financials).
call and webcast presentation
will conduct a conference call open to the public today 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 Q3 2023 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 Q3 2023 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.
archived webcast will be available for replay shortly after the close of the call.
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.
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 U.S. commercialization approval.
more information, please visit http://www.nyxoah.com/.
REGULATED INFORMATION
- CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in
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, 2022, filed with the Securities and Exchange
Commission ("SEC") on March 22, 2023, 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
any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking
statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained
in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking
statements, which speak only as of the date of this press release.
DeMartino, Chief Strategy Officer