REGULATED INFORMATION
Nyxoah Reports Second Quarter and First
Half 2022 Financial and Operating Results
DREAM enrollment complete, 12-month clinical data
expected in fall of 2023
Mont-Saint-Guibert, Belgium – August 8,
2022, 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 2022.
Second Quarter 2022 Financial and
Operating Highlights
- Completed enrollment in DREAM U.S. pivotal trial; expect
12-month clinical data in the fall of 2023 and regulatory approval
in the first half of 2024
- Generated revenue of €935,000 from the commercialization of
Genio® in Europe, primarily in Germany, which represents growth of
more than five times the amount achieved in the second quarter of
2021
- Activated 11 new implanting sites in Germany during the second
quarter, bringing the total to 26 as of June 30, 2022; expecting to
have at least 35 active implanting sites by the end of 2022
- Received FDA approval of IDE submission to commence the ACCCESS
study to treat complete concentric collapse (CCC) patients in the
U.S., with first patient implant expected in the fourth quarter of
2022
- Received FDA approval of the next generation Genio® 2.1 system
for use in the DREAM study and CE mark for use in commercial
patients in Europe; this improves patient comfort and compliance
with a new smartphone application and upgraded external activation
chip, which leverages Nyxoah’s scalable platform to continuously
enhance patient comfort and therapy efficacy without requiring a
new implant
- Partnered with Acurable to distribute the AcuPebble SA100
wearable home sleep test to OSA patients in Germany; launch is
expected in the fourth quarter of 2022
- Included in the newly formed Euronext Tech Leaders Index, which
is composed of 100+ innovative and high-growth technology companies
with greater than €1 trillion in aggregate market
capitalization
“We made significant progress on all of our key
strategic priorities this quarter, including activating 11 new
commercial sites in Germany, completing enrollment in our DREAM
trial, and receiving approval for our ACCCESS IDE,” commented
Olivier Taelman, Nyxoah’s Chief Executive Officer. “From a
commercial standpoint, our second quarter performance showing 42%
quarter-over-quarter growth strengthens our confidence that we will
achieve market leadership status in Germany by the end of
2022.”
“As the only commercially available hypoglossal
nerve stimulation (HGNS) therapy approved for the treatment of CCC
patients, we are encouraged by the first strong results from
patients who are six months post-implantation. These results,
combined with no longer having to perform a drug-induced sleep
endoscopy (DISE) procedure prior to implant, are driving physicians
to recommend Genio for their CCC and non-CCC patients,” continued
Mr. Taelman.
Mr. Taelman concluded, “In the meantime, we have
already begun investing in our U.S. market access organization. As
for our ACCCESS study, we expect to implant the first patients
before year end.”
Second Quarter and First Half 2022
Results
UNAUDITED CONDENSED CONSOLIDATED INTERIM
FINANCIAL INFORMATION – INTERIM CONSOLIDATED STATEMENTS OF LOSS AND
OTHER COMPREHENSIVE LOSS FOR THE THREE MONTHS AND SIX MONTHS
ENDED JUNE 30, 2022 (in thousands)
|
For the three months ended June 30 |
|
For the six months ended June 30 |
|
|
2022 |
2021 |
|
2022 |
2021 |
|
|
|
|
|
|
Revenue |
€
935 |
€
170 |
|
€
1 595 |
€
355 |
Cost
of goods sold |
(€ 334) |
(€ 63) |
|
(€ 623) |
(€ 115) |
Gross profit |
€ 601 |
€ 107 |
|
€ 972 |
€ 240 |
Research and Development Expense |
(€
3 470) |
(€
2 398) |
|
(€
7 065) |
(€
5 492) |
Selling, General and Administrative Expense |
(€
4 536) |
(€
3 913) |
|
(€
8 729) |
(€
6 279) |
Other
income/(expense) |
€
14 |
(€
101) |
|
€
150 |
(€
97) |
Operating loss for the period |
(€ 7 391) |
(€ 6 305) |
|
(€ 14 672) |
(€ 11 628) |
Financial income |
€
4 670 |
€
39 |
|
€
6 246 |
€
43 |
Financial expense |
(€ 2 162) |
(€ 574) |
|
(€ 2 950) |
(€ 899) |
Loss for the period before taxes |
(€ 4 883) |
(€ 6 840) |
|
(€ 11 376) |
(€ 12 484) |
Income
taxes |
(€ 107) |
(€ 99) |
|
(€ 315) |
(€ 124) |
Loss for the period |
(€ 4 990) |
(€ 6 939) |
|
(€ 11 691) |
(€ 12 608) |
|
|
|
|
|
|
Loss attributable to equity holders |
(€ 4 990) |
(€ 6 939) |
|
(€ 11 691) |
(€ 12 608) |
Other comprehensive loss |
|
|
|
|
|
Items that may be subsequently reclassified to profit or
loss (net of tax) |
|
|
|
|
|
Currency translation differences |
(€ 12) |
€ 262 |
|
(€ 114) |
€ 192 |
Total comprehensive loss for the year, net of
tax |
(€ 5 002) |
(€ 6 677) |
|
(€ 11 805) |
(€ 12 416) |
Loss attributable to equity holders |
(€ 5 002) |
(€ 6 677) |
|
(€ 11 805) |
(€ 12 416) |
|
|
|
|
|
|
Basic Loss Per Share (in EUR) |
(€ 0,193) |
(€ 0,314) |
|
(€ 0,453) |
(€ 0,570) |
Diluted Loss Per Share (in EUR) |
(€ 0,193) |
(€ 0,314) |
|
(€ 0,453) |
(€ 0,570) |
|
|
|
|
|
|
|
|
UNAUDITED CONDENSED CONSOLIDATED
INTERIM FINANCIAL INFORMATION – INTERIM CONSOLIDATED STATEMENT OF
FINANCIAL POSITION AS AT JUNE 30, 2022 (in
thousands)
|
|
|
As at |
|
|
|
June 30 2022 |
|
December 31 2021 |
ASSETS |
|
|
|
|
|
Non-current
assets |
|
|
|
|
|
Property, plant and equipment |
|
|
€ 2 111 |
|
€ 2 020 |
Intangible assets |
|
|
32 570 |
|
25 322 |
Right of use assets |
|
|
3 410 |
|
3 218 |
Deferred tax asset |
|
|
1 429 |
|
46 |
Other long-term receivables |
|
|
180 |
|
164 |
|
|
|
€ 39 700 |
|
€ 30 770 |
Current assets |
|
|
|
|
|
Inventory |
|
|
506 |
|
346 |
Trade receivables |
|
|
957 |
|
226 |
Other receivables |
|
|
1 548 |
|
2 286 |
Other current assets |
|
|
852 |
|
1 693 |
Financial assets |
|
|
47 717 |
|
− |
Cash and cash equivalents |
|
|
75 602 |
|
135 509 |
|
|
|
€ 127 182 |
|
€ 140 060 |
Total assets |
|
|
€ 166 882 |
|
€ 170 830 |
|
|
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
|
|
Capital and
reserves |
|
|
|
|
|
Capital |
|
|
4 438 |
|
4 427 |
Share premium |
|
|
228 158 |
|
228 033 |
Share based payment reserve |
|
|
4 411 |
|
3 127 |
Other comprehensive income |
|
|
88 |
|
202 |
Retained loss |
|
|
(98 850) |
|
(87 167) |
Total equity attributable to
shareholders |
|
|
€ 138 245 |
|
€ 148 622 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
|
Financial debt |
|
|
8 089 |
|
7 802 |
Lease liability |
|
|
2 859 |
|
2 737 |
Pension liability |
|
|
80 |
|
80 |
Provisions |
|
|
44 |
|
12 |
Deferred tax liability |
|
|
− |
|
5 |
|
|
|
€ 11 072 |
|
€ 10 636 |
Current
liabilities |
|
|
|
|
|
Financial debt |
|
|
661 |
|
554 |
Lease liability |
|
|
672 |
|
582 |
Trade payables |
|
|
4 301 |
|
3 995 |
Current tax liability |
|
|
4 391 |
|
2 808 |
Other payables |
|
|
7 540 |
|
3 633 |
|
|
|
€ 17 565 |
|
€ 11 572 |
Total liabilities |
|
|
€ 28 637 |
|
€ 22 208 |
Total equity and
liabilities |
|
|
€ 166 882 |
|
€ 170 830 |
UNAUDITED CONDENSED CONSOLIDATED
INTERIM FINANCIAL INFORMATION - INTERIM CONSOLIDATED STATEMENTS OF
CASH FLOWS AS AT JUNE 30, 2022 (in thousands)
|
|
|
For the six months ended June 30 |
|
|
|
2022 |
|
2021 |
CASH
FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
Loss
before tax for the year |
|
|
€ (11 376) |
|
€ (12 484) |
Adjustments
for |
|
|
|
|
|
Finance
income |
|
|
(6 246) |
|
(43) |
Finance
expenses |
|
|
2 950 |
|
899 |
Depreciation
and impairment of property, plant and equipment and right-of-use
assets |
|
|
536 |
|
377 |
Amortization
of intangible assets |
|
|
402 |
|
428 |
Share-based
payment transaction expense |
|
|
1 292 |
|
− |
Increase/(Decrease) in provisions |
|
|
32 |
|
− |
Other non-cash
items |
|
|
37 |
|
11 |
Cash
generated before changes in working capital |
|
|
€ (12 373) |
|
€ (10 812) |
Changes in
working capital |
|
|
|
|
|
Decrease/(Increase) in inventory |
|
|
(160) |
|
(27) |
(Increase)/Decrease in trade and other receivables |
|
|
1 011 |
|
(3 463) |
Increase/(Decrease) in trade and other payables |
|
|
2 053 |
|
6 061 |
Cash
generated from changes in operations |
|
|
€ (9 469) |
|
€ (8 241) |
Income tax
paid |
|
|
( 254) |
|
( 111) |
Net
cash used in operating activities |
|
|
€ (9 723) |
|
€ (8 352) |
CASH
FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
Purchases of
property, plant and equipment |
|
|
(302) |
|
(795) |
Capitalization
of intangible assets |
|
|
(7 650) |
|
(3 726) |
(Increase)/Decrease in financial assets - current |
|
|
(44 032) |
|
− |
Net
cash used in investing activities |
|
|
€ (51 984) |
|
€ (4 521) |
CASH
FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
Payment of
principal portion of lease liabilities |
|
|
(317) |
|
(236) |
Repayment of
other loan |
|
|
(42) |
|
(42) |
Interests
paid |
|
|
(134) |
|
(258) |
Repayment of
recoverable cash advance |
|
|
− |
|
(105) |
Proceeds from
issuance of shares, net of transaction costs |
|
|
136 |
|
362 |
Other
financial costs |
|
|
(8) |
|
(10) |
Net
cash generated from financing activities |
|
|
€ (365) |
|
€ (289) |
Movement in cash and cash equivalents |
|
|
€ (62 072) |
|
€ (13 162) |
Effect of
exchange rates on cash and cash equivalents |
|
|
2 165 |
|
33 |
Cash
and cash equivalents at January 1 |
|
|
€ 135 509 |
|
€ 92 300 |
Cash
and cash equivalents at June 30 |
|
|
€ 75 602 |
|
€ 79 171 |
Revenue
Revenue was €935,000 for the second quarter
ending June 30, 2022, compared to €170,000 for the second quarter
ending June 30, 2021. Revenue for the first half of 2022 was €1.6
million, compared to €355,000 for the first half of 2021. 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 €334,000 for the three
months ending June 30, 2022, representing a gross profit of
€601,000, or gross margin of 64.3%. This compares to total cost of
goods sold of €63,000 in the second quarter of 2021, for a gross
profit of €107,000, or gross margin of 62.9%.
For the six months ending June 30, 2022, total
cost of goods sold was €623,000, representing a gross profit of
€972,000, or gross margin of 60.9%. This compares to total cost of
goods sold of €115,000 in the first half of 2021, for a gross
profit of €240,000, or gross margin of 67.6%.
Research and Development Expenses
Research and Development expenses were €3.5
million for the three months ending June 30, 2022, versus €2.4
million for the prior year period, reflecting the Company’s
investments in the development of next generation versions of the
Genio® system as well as ongoing clinical studies, most notably
DREAM in the U.S.
For the six months ending June 30, 2022,
Research and Development expenses were €7.1 million, versus €5.5
million for the first half of 2021.
Selling, General and Administrative Expenses
Selling, General and Administrative expenses
rose to €4.5 million for the second quarter of 2022, up from €3.9
million in the second quarter of 2021. 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.
For the six months ending June 30, 2022,
Selling, General and Administrative expenses were €8.7 million, up
from €6.3 million in the first half of 2021 due to increased
commercial efforts in Germany and investments in Nyxoah’s corporate
infrastructure.
Operating Loss
Total operating loss for the second quarter and
first half of 2022 was €7.4 million and €14.7 million,
respectively, versus €6.3 million and €11.6 million in the second
quarter and first half of 2021, respectively. This was driven by
the acceleration in the Company’s R&D spending, as well as
ongoing commercial and clinical activities. Nyxoah realized a net
loss of €5.0 million and €11.8 million for the second quarter and
first half of 2022, respectively, compared to a net loss of €6.7
million and €12.4 million for the second quarter and first half of
2021, respectively.
Cash Position
As of June 30, 2022, cash and financial assets
totaled €123.3 million, compared to €135.5 million on December 31,
2021. Total cash burn was approximately €2.0 million per
month during the first half of 2022. Nyxoah expects monthly cash
burn to increase in the second half of 2022 to account for the
commencement of the ACCCESS IDE trial in the U.S., and the current
cash position provides ample liquidity to get to U.S.
commercialization in 2024.
First Half 2022 Report
Nyxoah’s financial report for the first half of
2022, including details of the audited 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 10:30 p.m. CET / 4:30 p.m. 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://register.vevent.com/register/BIfc3a52c9352e4e42958e9d816245b3b9
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:NyxoahLoic Moreau, Chief
Financial Officercorporate@nyxoah.com+32 473 33 19 80
Jeremy Feffer, VP IR and Corporate
Communicationsjeremy.feffer@nyxoah.com
+1 917 749 14
- ENGLISH_Q2 2022 Earnings PR Draft Final
Nyxoah (EU:NYXH)
Historical Stock Chart
Von Mär 2024 bis Apr 2024
Nyxoah (EU:NYXH)
Historical Stock Chart
Von Apr 2023 bis Apr 2024