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REGULATED INFORMATION Nyxoah Issues First Half 2021 Financial Results Mont-Saint-Guibert, Belgium

Key Takeaway: First Half 2021 Financial Results Mont-Saint-Guibert, Belgium - August 31, 2021, 10:30pm CET / 4:30pm ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company focused on the development and commercialization of innovative soluti

Full Press Release Details

First Half 2021 Financial Results
Mont-Saint-Guibert, Belgium - August 31,
2021, 10:30pm CET / 4:30pm 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 its unaudited condensed consolidated interim financial statements for the first half of 2021.
"In the first half of 2021, we kept
pace with our initiatives to deliver significant new accomplishments. In less than 12 months, we completed our second IPO with a
Nasdaq listing, further strengthening our balance sheet; made important gains in commercial activities in Germany, our initial
commercial proof of concept market; advanced clinical programs, including data to potentially expand our addressable market to
include CCC patients; and maintained focused investments in new products and technologies," said Olivier Taelman, CEO of
Nyxoah. "In the second half, we look forward to further accelerating our commercial activities in existing markets, enter new
markets, scale up, and advance clinical programs, including enrollment completion of our US DREAM study in the fourth
First Half 2021 Results
For the six months ended June 30
(in thousands) 2021 2020
Revenue 355 -
Cost of goods sold (115 ) -
Gross profit 240 -
General and administrative expenses (4 777) (2 400 )
Research and development expenses (1 255) (56 )
Clinical expenses (631 ) (509 )
Manufacturing expenses (2 171) (207 )
Quality assurance and regulatory expenses (642 ) (86 )
Patents fees & Related (793 ) (107 )
Therapy Development expenses (1 502) (761 )
Other operating income / (expenses), net (97 ) 184
Operating loss for the period (11 628) (3 942 )
Financial income 43 82
Financial expense (899 ) (416 )
Loss for the period before taxes (12 484) (4 276 )
Income taxes (124 ) (24 )
Loss for the period (12 608) (4 300 )
Loss attributable to equity holders (12 608) (4 300 )
Other comprehensive loss
Items that may be subsequently reclassified to profit or loss (net of tax)
Currency translation differences 192 (89 )
Total comprehensive loss for the year, net of tax (12 416) (4 389 )
Loss attributable to equity holders (12 416) (4 389 )
Basic Earnings Per Share (in EUR) (0.570 ) (0.262 )
Diluted Earnings Per Share (in EUR) (0.570 ) (0.262 )
Revenue was 355 thousand for the six months ended
June 30, 2021, compared to no revenue for the six months ended June 30, 2020. The increase in revenue was attributable to the
Company's commercialization of the Genio system mainly in Germany, and to a lesser extent, Spain and Belgium.
Cost of goods sold was 115 thousand for the six
months ended June 30, 2021, compared to no cost for the six months ended June 30, 2020. The increase in cost of goods sold was
attributable to the sales of the Genio system in Europe.
General and Administrative Expenses. General
and administrative expenses increased by 2.4 million, or 99 %, from 2.4 million for the six months ended June 30,
2020 to 4.8 million for the six months ended June 30, 2021 mainly due to an increase in consulting and contractors'
fees. The increase in consulting and contractors' fees includes variable compensations for an amount of 0.3 million for the
six months ended June 30, 2020 and 1.9 million for the six months ended June 30, 2021 related to a cash-settled share
based payment transaction and an increase of consultant services to support the company in legal, finance, tax and IT matters.
Research and Development Expenses. Before
capitalization of 0.6 million for the six months ended June 30, 2021 and 0.6 million for the six months ended June 30,
2020, research and development expenses increased by 1.1 million or 173 %, from 0.7 million for the six months ended June 30,
2020, to 1.8 million for the six months ended June 30, 2021, due to an increase in staff and consulting costs to support our
R&D activities. The Company started as of January 2021 to amortize its intangible assets. This explains the significant increase
of depreciation expenses for the six months ended June 30, 2021, compared to the six months ended June 30, 2020.
Clinical Expenses. Before capitalization
of 3.1 million for the six months ended June 30, 2021, and 1.4 million for the six months ended June 30, 2020, clinical
expenses increased by 1.8 million, or 96%, from 1.9 million for the six months ended June 30, 2020, to 3.7 million
for the six months ended June 30, 2021. The increase in the expenses was mainly due to an increase in staff and consulting to support
the completion of the BETTER SLEEP trial implantations, continuous recruitment for the EliSA trial and the ongoing DREAM IDE trial in
Manufacturing Expenses. Before capitalization
of 0.3 million for the six months ended June 30, 2021, and 1.2 million for the six months ended June 30, 2020, manufacturing
expenses increased by 1.0 million, or 72% from 1.4 million for the six months ended June 30, 2020, to 2.4 million
for the six months ended June 30, 2021. The increase in the expenses was mainly due to an increase in staff, in production and engineering
team to support capacity and yield improvement. In addition, manufacturing expenses increased for the six months ended June 30, 2021,
compared to the same period of 2020 due to the increase demand of our Genio system for non-commercial purposes (clinical
trials, development activities, etc) and, therefore, the increase of associated production costs.
Quality Assurance and Regulatory Expenses.
Before capitalization of 0.2 million for the six months ended June 30, 2021, and 0.5 million for the six months ended
June 30, 2020, quality assurance and regulatory expenses increased by 0.3 million, or 44% from 0.6 million for the six
months ended June 30, 2020, to 0.9 million for the six months ended June 30, 2021. The increase in the expenses was mainly
due to an increase in staff and QA & regulatory activities to support manufacturing scaling up process.
Patent Fees & Related Expenses.
Before capitalization of 0.2 million for the six months ended June 30, 2020, patents fees and related expenses increased by
0.5 million, or 199 % from 0.3 million for the six months ended June 30, 2020, to 0.8 million for the six months
ended June 30, 2021, due to expenses related the in-licensing agreement with Vanderbilt University.
Therapy Development Expenses. Therapy development
expenses increased by 0.7 million or 97 % from 0.8 million for the six months ended June 30, 2020, to 1.5 million
for the six months ended June 30, 2021. The increase in the expenses was mainly due to an increase in staff and consulting, to support
the launch of the commercialization in Europe.
Other Operating Income / (Expenses). The
Company had other operating expenses of 0.1 million for the six months ended June 30, 2021, and other operating income of 0.2
million for the six months ended June 30, 2020, the evolution being mainly due to the impact of the initial measurement and re-measurement
of the financial debt.
The Company realized a net loss of 12.6
million for the six months ended June 30, 2021, compared to a net loss of 4.3 million for the six months ended June 30,
2020, due to increases of activities in all departments.
Cash and cash equivalents totaled 79.2 million
on June 30, 2021, as compared to 23.9 million on June 30, 2020.
Net cash used in operations was 8.4 million
for the six months ended June 30, 2021 compared to 4.0 million for the six months ended June 30, 2020. The increase of
4.3 million was primarily due to an increase in a loss for the period of 8.2 million that was mainly attributable to increased
general and administrative expenses, research and development expenses, manufacturing expenses and therapy development expenses, which
were offset by a positive variation in the working capital and other non-cash transactions of 3.9 million.
Net cash used in investing activities was 4.5
million for the six months ended June 30, 2021 compared 3.7 million to the six months ended June 30, 2020.
Net cash used in financing activities for the
six months ended June 30, 2021 was 289 thousand compared to 25.7 million of net cash provided by financing activities during
the six months ended June 30, 2020. The decrease was due to the fact that no financing rounds have been organized in the first half
The Company's business, operational, and
clinical outlook for 2021 include the following expected milestones and goals:
First half-year report 2021
Nyxoah's financial report for the first
half of 2021, including details of the unaudited condensed consolidated financial statements, are available on the investor page of
Conference call and webcast presentation
Nyxoah will conduct a conference call to open
to the public tomorrow, September 1, 2021, at 3:00 p.m. CET / 9:00 a.m. ET, which will also be webcasted. To participate
in the conference call, please dial one of the following numbers:
Conference ID: 7468474
USA: (844) 260-3718
Belgium: 0800 73264
International: (929) 517-0938
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.
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 CE-validated, patient-centered, next generation hypoglossal neurostimulation therapy for OSA, the world's
most common sleep disordered breathing condition that is associated with increased mortality risk and comorbidities including cardiovascular
diseases, depression and stroke.
Following the successful completion of the BLAST
OSA study in patients with moderate to severe OSA, the Genio system received its European CE Mark in 2019. The Company has completed
the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion and is currently conducting the DREAM IDE pivotal
study for FDA approval and a post-marketing EliSA study in Europe to confirm the long-term safety and efficacy of the Genio system.
Last updated: Aug 31, 2021