Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023
10 January 2024 - 8:05AM
Nyxoah Announces Preliminary Results for
the Fourth Quarter and Full Year 2023
Mont-Saint-Guibert, Belgium – January 9,
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 announced certain preliminary, unaudited
results for the fourth quarter and full year ended December 31,
2023. Preliminary, Unaudited Fourth Quarter and
Full Year 2023 Results
- Revenue for the fourth quarter of
2023 is anticipated to be approximately €1.8 million, a 40%
increase over the fourth quarter of 2022 and an 87% increase over
the third quarter of 2023.
- Revenue for the full year 2023 is
anticipated to be approximately €4.3 million, a 41% increase over
the full year 2022.
- Ended the year with 48 active
German accounts.
“We are excited with the strong preliminary
fourth quarter sales, which are anticipated to be nearly double
from last quarter. This anticipated growth reflects both strong
underlying demand for Genio and focus on streamlining the patient
referral pathway through initiatives such as our direct-to-consumer
online campaigns launched in March,” commented Olivier Taelman,
Chief Executive Officer. “This performance throughout 2023 sets the
stage for an exciting 2024, as in a few months we expect to report
data from our DREAM US pivotal trial, file for FDA approval, begin
preparations to enter the US market, and begin to see contribution
from the ResMed commercial partnership in Germany.”
The preliminary, unaudited revenue results
described in this press release are estimates only and are subject
to revision until Nyxoah reports its full financial results for
2023 in its Annual Report on Form 20-F.
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
U.S. 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; reporting data from Nyxoah’s DREAM US pivotal trial; filing
for FDA approval; entrance to the US market, contributions from the
ResMed commercial partnership in Germany; 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
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- ENGLISH_Nyxoah Announces Preliminary Results for the Fourth
Quarter and Full Year 2023
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