REGULATED INFORMATION
Nyxoah Reports
Second Quarter
and First Half
2023
Financial and Operating
Results
Mont-Saint-Guibert, Belgium –
August 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 second quarter and
first half of 2023.
Recent Financial and
Operating Highlights
- Presented 12-month efficacy data1 on
the first 34 DREAM patients and safety data on all DREAM patients
at SLEEP 2023, demonstrating a 65% AHI responder rate, a 76% ODI
responder rate and safety in-line with expectations. These data are
preliminary and not conclusive of final DREAM success.
- Filed the second module in the
modular PMA submission.
- Accelerated U.S.
pre-commercialization efforts, focused on market access and
commercial leadership.
- Continued to
enroll the ACCCESS U.S. IDE pivotal study to treat complete
concentric collapse (CCC) patients. Implant completion is expected
in 2024.
- Reported second-quarter sales of
€1.1 million and ended the quarter with 42 active German
accounts.
- Ended the
quarter with a cash position of €84.5 million, providing an
anticipated cash runway into late 2024.
“Being less than nine months away from the DREAM
study readout, our attention continues to be on patient follow up.
We are highly encouraged by both the efficacy and safety data
presented at SLEEP 2023. Our modular PMA filing is well underway,
with the second module submitted during the quarter,” commented
Olivier Taelman, Nyxoah’s Chief Executive Officer. “We are building
strong commercial expertise in the competitive German market. Our
direct-to-consumer advertising, helpline and referral networks have
increased HGNS penetration and give us confidence on entering new
markets.”
CONSOLIDATED STATEMENTS OF LOSS AND OTHER
COMPREHENSIVE
LOSS (unaudited) (in thousands)
|
|
|
|
For the three months ended June 30 |
|
For the six months ended June 30 |
|
|
|
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenue |
|
|
€ 1,107 |
|
€ 936 |
|
€ 1,548 |
|
€ 1,595 |
|
Cost of goods
sold |
|
|
( 419) |
|
( 334) |
|
( 594) |
|
( 623) |
|
Gross
profit |
|
|
€ 688 |
|
€ 602 |
|
€ 954 |
|
€ 972 |
|
Research and
Development Expense |
|
|
(6,605) |
|
(3,470) |
|
(12,762) |
|
(7,065) |
|
Selling,
General and Administrative Expense |
|
|
(6,185) |
|
(4,536) |
|
(11,736) |
|
(8,729) |
|
Other
income/(expense) |
|
|
219 |
|
14 |
|
265 |
|
150 |
|
Operating loss for the period |
|
|
€ (11,883) |
|
€ (7,390) |
|
€ (23,279) |
|
€ (14,672) |
|
Financial
income |
|
|
789 |
|
4 669 |
|
1 414 |
|
6 246 |
|
Financial
expense |
|
|
( 775) |
|
(2 162) |
|
(1,732) |
|
(2 950) |
|
Loss
for the period before taxes |
|
|
€ (11,869) |
|
€ (4,883) |
|
€ (23,597) |
|
€ (11,376) |
|
Income
taxes |
|
|
( 928) |
|
( 107) |
|
(1,110) |
|
( 315) |
|
Loss
for the period |
|
|
€ (12,797) |
|
€ (4,990) |
|
€ (24,707) |
|
€ (11,691) |
|
|
|
|
|
|
|
|
|
|
|
|
Loss
attributable to equity holders |
|
|
€ (12,797) |
|
€ (4,990) |
|
€ (24,707) |
|
€ (11,691) |
|
Other
comprehensive loss |
|
|
|
|
|
|
|
|
|
|
Items
that may be subsequently reclassified to profit or loss (net of
tax) |
|
|
|
|
|
|
|
|
|
|
Currency
translation differences |
|
|
( 50) |
|
( 12) |
|
( 78) |
|
( 114) |
|
Total
comprehensive loss for the year, net of tax |
|
|
€ (12,847) |
|
€ (5,002) |
|
€ (24,785) |
|
€ (11,805) |
|
Loss
attributable to equity holders |
|
|
€ (12,847) |
|
€ (5,002) |
|
€ (24,785) |
|
€ (11,805) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic Loss Per
Share (in EUR) |
|
|
€ (0.447) |
|
€ (0.193) |
|
€ (0.907) |
|
€ (0.453) |
|
Diluted Loss
Per Share (in EUR) |
|
|
€ (0.447) |
|
€ (0.193) |
|
€ (0.907) |
|
€ (0.453) |
CONSOLIDATED STATEMENT OF FINANCIAL
POSITION (unaudited)
(in
thousands)
|
|
|
As at |
|
|
|
June 302023 |
|
December 31 2022 |
ASSETS |
|
|
|
|
|
Non-current assets |
|
|
|
|
|
Property,
plant and equipment |
|
|
2,813 |
|
2,460 |
Intangible
assets |
|
|
44,488 |
|
39,972 |
Right of use
assets |
|
|
3,571 |
|
3,159 |
Deferred tax
asset |
|
|
48 |
|
47 |
Other
long-term receivables |
|
|
165 |
|
173 |
|
|
|
€ 51,085 |
|
€ 45,811 |
Current assets |
|
|
|
|
|
Inventory |
|
|
1,146 |
|
882 |
Trade
receivables |
|
|
1,820 |
|
1,463 |
Other
receivables |
|
|
2,262 |
|
1,775 |
Other current
assets |
|
|
1,576 |
|
1,284 |
Financial
assets |
|
|
67,919 |
|
76,968 |
Cash and cash
equivalents |
|
|
16,604 |
|
17,888 |
|
|
|
€ 91,327 |
|
€ 100,260 |
Total assets |
|
|
€ 142,412 |
|
€ 146,071 |
|
|
|
|
|
|
EQUITY
AND LIABILITIES |
|
|
|
|
|
Capital and reserves |
|
|
|
|
|
Capital |
|
|
4,924 |
|
4,440 |
Share
premium |
|
|
246,070 |
|
228,275 |
Share based
payment reserve |
|
|
7,005 |
|
5,645 |
Other
comprehensive income |
|
|
98 |
|
176 |
Retained
loss |
|
|
(142,522) |
|
(118,212) |
Total equity attributable to shareholders |
|
|
€ 115,575 |
|
€ 120,324 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
Financial
debt |
|
|
8,433 |
|
8,189 |
Lease
liability |
|
|
2,991 |
|
2,586 |
Pension
liability |
|
|
50 |
|
− |
Provisions |
|
|
127 |
|
59 |
Deferred tax
liability |
|
|
− |
|
− |
|
|
|
€ 11,601 |
|
€ 10,834 |
Current liabilities |
|
|
|
|
|
Financial
debt |
|
|
559 |
|
388 |
Lease
liability |
|
|
751 |
|
719 |
Trade
payables |
|
|
4 690 |
|
4,985 |
Current tax
liability |
|
|
4 475 |
|
3,654 |
Other
payables |
|
|
4 761 |
|
5,167 |
|
|
|
€ 15,236 |
|
€ 14,913 |
Total liabilities |
|
|
€ 26,837 |
|
€ 25,747 |
Total equity and liabilities |
|
|
€ 142,412 |
|
€ 146,071 |
Revenue
Revenue was €1.1 million for the second quarter
ending June 30, 2023, compared to €0.9 million for second quarter
ending June 30, 2022.
Cost of Goods Sold
Cost of goods sold was €0.4 million for the
three months ending June 30, 2023, representing a gross profit of
€0.7 million, or gross margin of 62.2%. This compares to total cost
of goods sold of €0.3 million in the second quarter ending June 30,
2022, for a gross profit of €0.6 million, or gross margin of
64.3%.
Research and Development Expenses
Research and development expenses were €6.6
million for the three months ending June 30, 2023, versus €3.5
million for the prior year period, driven by an acceleration in
clinical activities, notably the start of the ACCCESS study.
Selling, General and Administrative Expenses
Selling, general and administrative expenses
rose to €6.2 million for the second quarter of 2023, up from €4.5
million in the second 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 second quarter 2023
was €11.9 million versus €7.4 million in the second 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 June 30,
2023, cash and financial assets totaled €84.5 million, compared to
€94.9 million on December 31, 2022. Total cash burn was
approximately €4.8 million per month during the second quarter of
2023.
First Half 2023
ReportNyxoah’s financial report for the first half
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. A webcast of the call
will be accessible via the Investor Relations page of the Nyxoah
website or through this link: Nyxoah's Q2 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 Q2 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.
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
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
statementsCertain 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
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_Q2 2023 Earnings PR
Nyxoah (NASDAQ:NYXH)
過去 株価チャート
から 5 2024 まで 6 2024
Nyxoah (NASDAQ:NYXH)
過去 株価チャート
から 6 2023 まで 6 2024