Nyxoah Reports Second Quarter and First Half 2024 Financial and
Operating Results
REGULATED INFORMATION
Nyxoah Reports Second Quarter and First Half
2024 Financial and Operating Results
FDA regulatory submission complete, U.S. approval on track for
end of 2024
U.S. commercial launch fully funded with over €85 million in new
capital raised
Mont-Saint-Guibert, Belgium – August 6, 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 second quarter and
first half of 2024.
Recent Financial and Operating
Highlights
- Submitted final module in the modular PMA submission,
initiating FDA interactive review.
- Strengthening U.S. commercial organization, highlighted
by the appointments of Scott Holstine as Chief Commercial Officer
and key sales, marketing and market access leaders.
- Raised over €85 million in growth capital through a €48.5
million equity offering and a €37.5 million loan facility agreement
with the European Investment Bank (EIB).
- Reported second quarter 2024 sales of €0.8 million and
first half 2024 sales growth of 29% over the same period last
year.
- Total cash position of €77.8 million at the end of the
quarter, excluding the €37.5 million EIB loan facility.
“With the FDA interactive review well advancing,
our focus is fully shifted to U.S. commercial readiness. Key
commercial leadership is in place, and we are kicking off the
recruitment of top sales and marketing talents. We will present
the full DREAM U.S. pivotal study data at the ISSS meeting in
September, which will further differentiate Genio’s unique, patient
centric hypoglossal nerve stimulation solution,” commented
Olivier Taelman, Nyxoah Chief Executive officer. “Our
recent €85 million in capital raise provides us with a cash
runway into mid-2026, fully funding the U.S. launch.”
Second Quarter and First Half 2024
Results
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, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Revenue |
771 |
|
1,107 |
|
1,992 |
|
1,548 |
Cost of goods sold |
(281) |
|
(419) |
|
(735) |
|
(594) |
Gross profit |
€490 |
|
€688 |
|
€1,257 |
|
€954 |
Research and Development
Expense |
(7,472) |
|
(6,605) |
|
(14,671) |
|
(12,762) |
Selling, General and Administrative
Expense |
(6,383) |
|
(6,185) |
|
(12,355) |
|
(11,736) |
Other income/(expense) |
58 |
|
219 |
|
249 |
|
265 |
Operating loss for the
period |
€(13,307) |
|
€(11,883) |
|
€(25,520) |
|
€(23,279) |
Financial income |
2,069 |
|
789 |
|
3,477 |
|
1,414 |
Financial expense |
(1,445) |
|
( 775) |
|
(2,436) |
|
(1,732) |
Loss for the period before
taxes |
€(12,683) |
|
€(11,869) |
|
€(24,479) |
|
€(23,597) |
Income taxes |
(441) |
|
(928) |
|
(551) |
|
(1,110) |
Loss for the period |
€(13,124) |
|
€(12,797) |
|
€(25,030) |
|
€(24,707) |
|
|
|
|
|
|
|
|
Loss attributable to equity
holders |
€ (13,124) |
|
€(12,797) |
|
€(25,030) |
|
€(24,707) |
|
|
|
|
|
|
|
|
Other comprehensive
income/(loss) |
|
|
|
|
|
|
|
Items that may not be subsequently
reclassified to profit or loss (net of tax) |
|
|
|
|
|
|
|
Currency translation
differences |
(82) |
|
(50) |
|
(22) |
|
(78) |
Total comprehensive loss for the
year, net of tax |
€(13,206) |
|
€(12,847) |
|
€(25,052) |
|
€(24,785) |
Loss attributable to equity
holders |
€(13,206) |
|
€(12,847) |
|
€(25,052) |
|
€(24,785) |
|
|
|
|
|
|
|
|
Basic loss per share (in EUR) |
€(0.428) |
|
€(0.447) |
|
€(0.843) |
|
€(0.907) |
Diluted loss per share (in
EUR) |
€(0.428) |
|
€(0.447) |
|
€(0.843) |
|
€(0.907) |
CONSOLIDATED STATEMENT OF FINANCIAL
POSITION (unaudited)
(in thousands)
|
|
|
As at |
|
|
|
June 30,
2024 |
|
December 31, 2023 |
ASSETS |
|
|
|
|
|
Non-current assets |
|
|
|
|
|
Property, plant and equipment |
|
|
4,386 |
|
4,188 |
Intangible assets |
|
|
49,310 |
|
46,608 |
Right
of use assets |
|
|
3,391 |
|
3,788 |
Deferred tax asset |
|
|
51 |
|
56 |
Other
long-term receivables |
|
|
1,419 |
|
1,166 |
|
|
|
€ 58,557 |
|
€ 55,806 |
Current assets |
|
|
|
|
|
Inventory |
|
|
5,098 |
|
3,315 |
Trade
receivables |
|
|
2,609 |
|
2,758 |
Other
receivables |
|
|
2,885 |
|
3,212 |
Other
current assets |
|
|
1,298 |
|
1,318 |
Financial assets |
|
|
50,061 |
|
36,138 |
Cash
and cash equivalents |
|
|
27,724 |
|
21,610 |
|
|
|
€ 89,675 |
|
€ 68,351 |
Total assets |
|
|
€ 148,232 |
|
€ 124,157 |
|
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
|
Capital and reserves |
|
|
|
|
|
Capital |
|
|
5,905 |
|
4,926 |
Share
premium |
|
|
290,822 |
|
246,127 |
Share
based payment reserve |
|
|
8,841 |
|
7,661 |
Other
comprehensive income |
|
|
115 |
|
137 |
Retained loss |
|
|
(185,540) |
|
(160,829) |
Total equity attributable to shareholders |
|
|
€ 120,143 |
|
€ 98,022 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
Financial debt |
|
|
8,600 |
|
8,373 |
Lease
liability |
|
|
2,721 |
|
3,116 |
Pension liability |
|
|
35 |
|
9 |
Provisions |
|
|
339 |
|
185 |
Deferred tax liability |
|
|
10 |
|
9 |
|
|
|
€11,705 |
|
€ 11,692 |
Current liabilities |
|
|
|
|
|
Financial debt |
|
|
595 |
|
364 |
Lease
liability |
|
|
827 |
|
851 |
Trade
payables |
|
|
9,078 |
|
8,108 |
Current tax liability |
|
|
2,335 |
|
1,988 |
Other
payables |
|
|
3,549 |
|
3,132 |
|
|
|
€ 16,384 |
|
€ 14,443 |
Total liabilities |
|
|
€ 28,089 |
|
€ 26,135 |
Total equity and liabilities |
|
|
€ 148,232 |
|
€ 124,157 |
Revenue
Revenue was €0.8 million for the second quarter ending June 30,
2024, compared to €1.1 million for the second quarter ending June
30, 2023.
Cost of Goods Sold
Cost of goods sold was €281,000 for the three
months ending June 30, 2024, representing a gross profit of
€490,000, or gross margin of 63.6%. This compares to total cost of
goods sold of €419,000 in the second quarter of 2023, for a gross
profit of €0.7 million, or gross margin of 62.2%.
Research and Development
For the second quarter ending June 30, 2024, research and
development expenses were €7.5 million, versus €6.6 million for the
second quarter ending June 30, 2023.
Operating Loss
Total operating loss for the second quarter ending June 30, 2024
was €13.3 million versus €11.9 million in the second quarter ending
June 30, 2023. This was driven by the acceleration in the Company’s
R&D spending, as well as ongoing commercial and clinical
activities.
Cash Position
As of June 30, 2024, cash and financial assets totaled €77.8
million, compared to €57.7 million on December 31, 2023. Total
cash burn was approximately €4.0 million per month during the
second quarter 2024.
Second Quarter and First Half 2024
Nyxoah’s financial report for the second quarter and first half
2024, 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
Company management will host a conference call to discuss financial
results on Tuesday, August 6, 2024, beginning 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 2024 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 2024 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 Nyxoah
Nyxoah 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
announced positive outcomes from the DREAM IDE pivotal study for
FDA and U.S. commercialization approval.
For more information, please see the Company’s
annual report for the financial year 2023 and
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 entry into of the loan facility
agreement and the synthetic warrant agreement with the EIB; the use
of proceeds from the loan facility agreement; the Genio® system 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
U.S. pivotal trial; filing for FDA approval; and entrance to the
U.S. market. 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, 2023, filed with the
Securities and Exchange Commission (“SEC”) on March 20, 2024, 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:
Nyxoah
David DeMartino, Chief Strategy Officer
IR@nyxoah.com
For Media
Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be
International/Germany
MC Services – Anne Hennecke
anne.hennecke@mc-services.eu
- ENGLISH Q2 2024 Earnings PR
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