Nyxoah Reports Fourth Quarter and Financial Year 2023 Financial and
Operating Results
Nyxoah Reports Fourth Quarter and
Financial Year 2023 Financial and Operating ResultsExpect
to report DREAM U.S. pivotal study efficacy and safety data by
early AprilAchieved record quarterly sales of €1.8 million
Mont-Saint-Guibert, Belgium – March 5,
2024 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 fourth quarter and
financial year 2023.
Recent Financial and Operating
Highlights
- Filed the third out of four modules
in the U.S. modular PMA submission.
- Achieved quarterly sales of €1.8
million, representing sequential quarterly growth of 87% and
increasing 42% year-over-year.
- Achieved 2023 full year sales of
€4.3 million, representing 41% year-over-year growth.
- Ended the year with 48 active
German accounts, up from 38 entering 2023.
- Total cash position of €57.7
million at the end of 2023.
2024 Strategic Priorities
- Complete patient
follow up in the DREAM U.S. pivotal study and report efficacy and
safety data by early April.
- File the fourth and final module in
the modular PMA submission.
- Accelerate investments in the U.S.
commercial organization in preparation for a late 2024 launch.
- Complete enrollment in the ACCCESS
complete concentric collapse (CCC) U.S. pivotal study.
- Increase hypoglossal nerve
stimulation (HGNS) market penetration and Genio market share in
Europe.
“In 2023, we completed enrollment in our DREAM
U.S. pivotal study, presented positive early DREAM efficacy and
safety data, initiated enrollment in our ACCCESS U.S. pivotal study
for complete concentric collapse and raised capital from both
existing and new investors. These accomplishments strengthen our
confidence for a transformational 2024.” commented Olivier Taelman,
Nyxoah Chief Executive Officer. “We are excited to report DREAM
data in the coming weeks, finalize the regulatory FDA submission
and pave the way for bringing Genio® to patients in the U.S.”
Mr. Taelman continued, “Commercially in Europe,
this quarter’s performance was the strongest in Nyxoah’s history
driven by a targeted direct-to-consumer (DTC) effort and I applaud
our European commercial team for their execution. I look forward to
a further increase in therapy penetration from our partnership with
ResMed in Germany.”
Fourth Quarter and Full Year 2023
Results
UNAUDITED CONDENSED CONSOLIDATED
FINANCIAL INFORMATION – CONSOLIDATED STATEMENTS OF LOSS AND OTHER
COMPREHENSIVE LOSS FOR THE THREE MONTHS AND YEARS ENDED
DECEMBER 31, 2023 AND DECEMBER 31, 2022 (in
thousands)
|
For the three months ended December 31, |
|
For the year ended December 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenue |
€1,824 |
|
€1,307 |
|
€4,348 |
|
€3,084 |
Cost of goods sold |
(726) |
|
(465) |
|
(1,656) |
|
(1,150) |
Gross profit |
€1,098 |
|
€842 |
|
€2,692 |
|
€1,934 |
Research and Development Expense |
(7,321) |
|
(4,575) |
|
(26,651) |
|
(15,861) |
Selling, General and Administrative Expense |
(4,893) |
|
(5,363) |
|
(21,687) |
|
(18,855) |
Other income/(expense) |
279 |
|
46 |
|
544 |
|
283 |
Operating loss for the period |
€(10,837) |
|
€(9,050) |
|
€(45,102) |
|
€(32,499) |
Financial income |
582 |
|
(4,609) |
|
4,174 |
|
6,763 |
Financial expense |
(964) |
|
1,153 |
|
(3,729) |
|
(4,320) |
Loss for the period before taxes |
€(11,219) |
|
€(12,506) |
|
€(44,657) |
|
€(30,056) |
Income taxes |
326 |
|
(790) |
|
1,445 |
|
(1,169) |
Loss for the period |
€(10,893) |
|
€(13,296) |
|
€(43,212) |
|
€(31,225) |
|
|
|
|
|
|
|
|
Loss attributable to equity holders |
€(10,893) |
|
€(13,296) |
|
€(43,212) |
|
€(31,225) |
|
|
|
|
|
|
|
|
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 |
81 |
|
70 |
|
81 |
|
70 |
Items that may be subsequently reclassified to profit or
loss (net of tax) |
|
|
|
|
|
|
|
Currency translation differences |
(32) |
|
(82) |
|
(120) |
|
(96) |
Total other comprehensive income/(loss) |
€(39) |
|
€(12) |
|
€(39) |
|
€(26) |
Total comprehensive loss for the year, net of
tax |
€(10,844) |
|
€(13,308) |
|
€ (43,251) |
|
€ (31,251) |
Loss attributable to equity holders |
€(10,844) |
|
€(13,308) |
|
€ (43,251) |
|
€ (31,251) |
|
|
|
|
|
|
|
|
Basic loss per share (in EUR) |
€(379) |
|
€(514) |
|
€(1,545) |
|
€(1,209) |
Diluted loss per share (in EUR) |
€(379) |
|
€(514) |
|
€(1,545) |
|
€(1,209) |
UNAUDITED CONDENSED CONSOLIDATED
FINANCIAL INFORMATION – CONSOLIDATED STATEMENT OF FINANCIAL
POSITION AS OF DECEMBER 31, 2023 AND DECEMBER 31,
2022 (in thousands)
|
As at December 31 |
|
2023 |
|
2022 |
ASSETS |
|
|
|
Non-current assets |
|
|
|
Property, plant and equipment |
€4,188 |
|
€2,460 |
Intangible assets |
46,608 |
|
39,972 |
Right of use assets |
3,788 |
|
3,159 |
Deferred tax asset |
56 |
|
47 |
Other long-term receivables |
1,166 |
|
173 |
|
€55,806 |
|
€45,811 |
Current assets |
|
|
|
Inventory |
3,315 |
|
882 |
Trade receivables |
2,758 |
|
1,463 |
Other receivables |
3,212 |
|
1,775 |
Other current assets |
1,318 |
|
1,284 |
Financial assets |
36,138 |
|
76,968 |
Cash and cash equivalents |
21,610 |
|
17,888 |
|
€68,351 |
|
€100,260 |
Total assets |
€124,157 |
|
€146,071 |
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
Capital and reserves |
|
|
|
Capital |
4,926 |
|
4,440 |
Share premium |
246,127 |
|
228,275 |
Share based payment reserve |
7,661 |
|
5,645 |
Other comprehensive income |
137 |
|
176 |
Retained loss |
(160,829) |
|
(118,212) |
Total equity attributable to shareholders |
€98,022 |
|
€120,324 |
|
|
|
|
LIABILITIES |
|
|
|
Non-current liabilities |
|
|
|
Financial debt |
8,373 |
|
8,189 |
Lease liability |
3,116 |
|
2,586 |
Pension liability |
9 |
|
− |
Provisions |
185 |
|
59 |
Deferred tax liability |
9 |
|
− |
|
€11,692 |
|
€10,834 |
Current liabilities |
|
|
|
Financial debt |
364 |
|
388 |
Lease liability |
851 |
|
719 |
Trade payables |
6,155 |
|
4,985 |
Current tax liability |
1,988 |
|
3,654 |
Other payables |
5,085 |
|
5,167 |
|
€14,443 |
|
€14,913 |
Total liabilities |
€26,135 |
|
€25,747 |
Total equity and liabilities |
€124,157 |
|
€146,071 |
Revenue
Revenue was €1.8 million for the fourth quarter
ending December 31, 2023, compared to €1.3 million for the fourth
quarter ending December 31, 2022. Revenue for the full year of 2023
was €4.3 million, compared to €3.1 million for the full year of
2022. The increase in revenue was attributable to the Company’s
commercialization of the Genio® system, primarily in Germany.
Cost of Goods Sold
Cost of goods sold was €726,000 for the three
months ending December 31, 2023, representing a gross profit of
€1.1 million, or gross margin of 60%. This compares to total cost
of goods sold of €465,000 in the fourth quarter of 2022, for a
gross profit of €842,000, or gross margin of 64.4%.
For the full year ending December 31, 2023,
total cost of goods sold was €1.7 million, representing a gross
profit of €2.7 million, or gross margin of 62%. This compares to
total cost of goods sold of €1.2 million for the full year of 2022,
for a gross profit of €1.9 million, or gross margin of 62.7%.
Research and Development
For the full year ending December 31, 2023,
research and development expenses were €26.7 million, versus €15.9
million for the full year of 2022.
Operating Loss
Total operating loss for the fourth quarter and
full year 2023 was €10.8 million and €45.1 million, respectively,
versus €9.1 million and €32.5 million in the fourth quarter and
full year 2022, respectively. This was driven by the acceleration
in the Company’s R&D spending, as well as ongoing commercial
and clinical activities.
Cash PositionAs of December 31,
2023, cash and financial assets totaled €57.7 million, compared to
€94.9 million on December 31, 2022. Total cash burn was
approximately €4.6 million per month during 2023.
Full year report 2023Our
independent auditor has not yet completed the audit of the
financial statements for the year ended December 31, 2023.
When published, the Nyxoah financial report for the full year of
2023 will be available on the investor page of Nyxoah’s website
(https://investors.nyxoah.com/financials).
Conference call and webcast
presentation A webcast of the call will be accessible via
the Investor Relations page of the Nyxoah website or through this
link: Nyxoah's Q4 2023 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 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.
About NyxoahNyxoah 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.
For more information, please visit
http://www.nyxoah.com/.
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; 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.
Contacts:NyxoahDavid DeMartino,
Chief Strategy Officerdavid.demartino@nyxoah.com +1 310 310
1313
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