REGULATED INFORMATION
Nyxoah Reports First Quarter 2023
Financial and Operating Results
Mont-Saint-Guibert, Belgium – May 16,
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 first
quarter of 2023.
Recent Financial and Operating
Highlights
- Completed all 115 implants in the DREAM U.S. pivotal
trial, with 12-month data expected in the first quarter of
2024.
- Initiated the modular PMA submission with the filing of
the first module.
- Submitted 12-month data1 on the first 34 DREAM
patients as a late-breaking abstract to SLEEP 2023 demonstrating a
65% AHI responder rate, a 76% ODI responder rate and safety in-line
with expectations. The abstract will be presented in a
late-breaking poster session on June 6th. These data are
preliminary and not conclusive of final DREAM success.
- Implanted the first patients in the ACCCESS U.S. IDE
pivotal study to treat complete concentric collapse (CCC). Implant
completion expected in 2024.
- Hired Christoph Eigenmann as Chief Commercial
Officer.
- Raised €19 million from new and historical
shareholders including ResMed, Cochlear and Robert Taub, Nyxoah’s
Chairman and Founder.
- Ended the quarter with 40 active German accounts and
quarterly sales of €441 thousand.
- Expanded European market access with first implants in
Austria.
- Strengthened the supply chain with the Belgium
manufacturing facility receiving clearance from the EU notified
body.
“In 2023, our focus is in the U.S. on DREAM
patient follow up resulting in reaching the primary endpoints. I am
excited by the data on the first 34 patients and look forward to
sharing the full abstract results at SLEEP 2023 next month. Our
increasing conviction in DREAM outcomes is accelerating investment
in our commercial organization, starting with the addition of
Christoph as Chief Commercial Officer,” commented Olivier Taelman,
Nyxoah’s Chief Executive Officer. “Christoph’s hire, along with
the €19 million raised from key investors, puts us in a strong
position as we embark on our next stage of growth.”
First Quarter 2023 Results
UNAUDITED CONDENSED CONSOLIDATED
FINANCIAL INFORMATION – CONSOLIDATED STATEMENTS OF LOSS AND OTHER
COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31,
2023 (in thousands)
|
|
|
|
For the three months ended March 31 |
|
|
|
|
2023 |
|
2022 |
Revenue |
|
|
€441 |
|
€660 |
Cost of
goods sold |
|
|
(175) |
|
(289) |
Gross profit |
|
|
€266 |
|
€371 |
Research
and Development Expense |
|
|
(6,157) |
|
(3,595) |
Selling,
General and Administrative Expense |
|
|
(5,551) |
|
(4,193) |
Other
income/(expense) |
|
|
46 |
|
136 |
Operating loss for the period |
|
|
€(11,396) |
|
€(7,281) |
Financial
income |
|
|
625 |
|
1,576 |
Financial
expense |
|
|
(958) |
|
(788) |
Loss for the period before taxes |
|
|
€(11,729) |
|
€(6,493) |
Income
taxes |
|
|
(182) |
|
(208) |
Loss for the period |
|
|
€(11,911) |
|
€(6,701) |
|
|
|
|
|
|
Loss attributable to equity holders |
|
|
€(11,911) |
|
€(6,701) |
Other comprehensive loss |
|
|
|
|
|
Items that may be subsequently reclassified to profit
or loss (net of tax) |
|
|
|
|
|
Currency
translation differences |
|
|
(28) |
|
( 102) |
Total comprehensive loss for the year, net of
tax |
|
|
€(11,939) |
|
€(6,803) |
Loss attributable to equity holders |
|
|
€(11,939) |
|
€(6,803) |
|
|
|
|
|
|
Basic Loss Per Share (in EUR) |
|
|
€(0.460) |
|
€(0.260) |
Diluted
Loss Per Share (in EUR) |
|
|
€(0.460) |
|
€(0.260) |
|
|
|
|
|
|
|
|
|
|
|
|
UNAUDITED CONDENSED CONSOLIDATED
FINANCIAL INFORMATION – CONSOLIDATED STATEMENT OF FINANCIAL
POSITION AS OF MARCH 31, 2023 (in thousands)
|
|
|
|
As at |
|
|
|
|
|
March 312023 |
|
December 31 2022 |
|
|
ASSETS |
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
|
Property, plant and equipment |
|
|
€2,721 |
|
€2,460 |
|
|
Intangible assets |
|
|
42,447 |
|
39,972 |
|
|
Right
of use assets |
|
|
3,669 |
|
3,159 |
|
|
Deferred tax asset |
|
|
50 |
|
47 |
|
|
Other
long-term receivables |
|
|
169 |
|
173 |
|
|
|
|
|
€49,056 |
|
€45,811 |
|
|
Current assets |
|
|
|
|
|
|
|
Inventory |
|
|
1,249 |
|
882 |
|
|
Trade
receivables |
|
|
1,499 |
|
1,463 |
|
|
Other
receivables |
|
|
1,419 |
|
1,775 |
|
|
Other
current assets |
|
|
1,663 |
|
1,284 |
|
|
Financial assets |
|
|
62,403 |
|
76,968 |
|
|
Cash
and cash equivalents |
|
|
33,664 |
|
17,888 |
|
|
|
|
|
€101,897 |
|
€100,260 |
|
|
Total assets |
|
|
€150,953 |
|
€146,071 |
|
|
|
|
|
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
|
|
|
Capital and reserves |
|
|
|
|
|
|
|
Capital |
|
|
4,859 |
|
4,440 |
|
|
Share
premium |
|
|
243,488 |
|
228,275 |
|
|
Share
based payment reserve |
|
|
6,582 |
|
5,645 |
|
|
Other
comprehensive income |
|
|
148 |
|
176 |
|
|
Retained loss |
|
|
(130,051) |
|
(118,212) |
|
|
Total equity attributable to shareholders |
|
|
€125,026 |
|
€120,324 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
|
|
Financial debt |
|
|
8,381 |
|
8,189 |
|
|
Lease
liability |
|
|
3,112 |
|
2,586 |
|
|
Pension liability |
|
|
25 |
|
− |
|
|
Provisions |
|
|
74 |
|
59 |
|
|
Deferred tax liability |
|
|
− |
|
− |
|
|
|
|
|
€11,592 |
|
€10,834 |
|
|
Current liabilities |
|
|
|
|
|
|
|
Financial debt |
|
|
390 |
|
388 |
|
|
Lease
liability |
|
|
711 |
|
719 |
|
|
Trade
payables |
|
|
5,012 |
|
4,985 |
|
|
Current tax liability |
|
|
3,619 |
|
3,654 |
|
|
Other
payables |
|
|
4,603 |
|
5,167 |
|
|
|
|
|
€14,335 |
|
€14,913 |
|
|
Total liabilities |
|
|
€25,927 |
|
€25,747 |
|
|
Total equity and liabilities |
|
|
€150,953 |
|
€146,071 |
|
|
|
|
|
|
|
|
|
|
|
Revenue
Revenue was €441,000 for the first quarter
ending March 31, 2023, compared to €660,000 for first quarter
ending March 31, 2022.
Cost of Goods Sold
Cost of goods sold was €175,000 for the three
months ending March 31, 2023, representing a gross profit of
€266,000, or gross margin of 60.3%. This compares to total cost of
goods sold of €289,000 in the first quarter ending March 31, 2022,
for a gross profit of €371,000, or gross margin of 56.2%.
Research and Development Expenses
Research and development expenses were €6.2
million for the three months ending March 31, 2023, versus €3.6
million for the prior year period, driven by an acceleration in
clinical activities, notable the start of the ACCCESS
study.
Selling, General and Administrative Expenses
Selling, general and administrative expenses
rose to €5.6 million for the first quarter of 2023, up from €4.2
million in the first 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
Total operating loss for the first quarter 2023
was €11.4 million versus €7.3 million in the first quarter of 2022.
This was driven by the acceleration in the Company’s R&D
spending, as well as ongoing commercial and clinical
activities.
Cash PositionAs of March 31,
2023, cash and financial assets totaled €96.1 million, compared to
€94.9 million on December 31, 2022. Total cash burn was
approximately €4.9 million per month during the first quarter of
2023.
First Quarter 2023
ReportNyxoah’s financial report for the first quarter of
2023, including details of the consolidated results, are available
on the investor page of Nyxoah’s website
(https://investors.nyxoah.com/financials).
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://edge.media-server.com/mmc/p/imeku8f7
A 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.
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, 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 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
1 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 follow-up.
- ENGLISH_Q1 2023 Earnings PR_FINAL
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