Full Press Release Details
REGULATED INFORMATION
Full Year 2021 Operating and Financial Results
Belgium - March 24, 2022, 9:30pm 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 reported financial and operating results for the full year ending December 31, 2021.
Operational and Financial Highlights
a very strong year for Nyxoah. I am proud of the team maintaining their focus on execution while operating in a challenging market environment.
We reached numerous milestones in 2021 and feel we are well positioned to further build on this momentum in 2022," commented Olivier
Taelman, Nyxoah's Chief Executive Officer. "Through the BETTER SLEEP study results, we are now able to offer an effective
solution for CCC patients with an expanded CE mark indication in Europe, and we are working hard to initiate a CCC-focused IDE trial
in the US. Particularly encouraging are the strong responder rates in all patient cohorts, further increasing our confidence in positive
outcomes from the ongoing DREAM study."
REGULATED INFORMATION
also been happy with our commercial progress in Europe, focusing on Germany, where we obtained a dedicated DRG code." continued
Mr. Taelman. "We already had 12 active implant sites in December 2021 and continue to expand rapidly. In addition, we have secured
a DRG code in Switzerland and hospital reimbursement in Spain while we await final reimbursement decisions in the Netherlands and Belgium.
Our commercial strategy is based on a deep understanding of the patient journey, building strong relationships with implanting surgeons
and further strengthening their relationships with referring sleep physicians, in combination with digital marketing programs."
Mr. Taelman continued,
"We secured CE mark MR conditional labeling for Genio , enabling all implanted patients to safely undergo 1.5T and 3T MRI diagnostics
scans. Genio is now the only HGNS device with an MRI compatibility label for full-body and 3T. This illustrates our patient-centric
strategy, and you can soon expect to hear more on the progress made by our R&D team. Short term, we expect to launch the next generation
Genio 2.1, which includes a patient-centric smartphone app and will incorporate a position sensor to adjust stimulation levels based
on sleeping position. Looking further into the future, we are proud of our collaboration with Vanderbilt University and Dr. Kent that
should result in novel treatment options for OSA patients, starting with Ansa Cervicalis stimulation."
second successful IPO in the span of 10 months last July, we have a strong balance sheet that provides ample liquidity to complete the
DREAM study, conduct our U.S. CCC IDE study, invest in pre-commercial activities in the U.S., and remain committed to our important R&D
priorities. We are extremely excited about where we are today as a company, and we look forward to providing further updates as the year
progresses," concluded Mr. Taelman.
REGULATED INFORMATION
| CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS | ||
| (in thousands) |
| For the year ended December 31 | |||||||
| 2021 | 2020 | ||||||
| Revenue | 852 | 69 | |||||
| Cost of goods sold | -303 | -30 | |||||
| Gross profit | 549 | 39 | |||||
| General and administrative expenses | (11 113 | ) | (7 522 | ) | |||
| Research and development expenses | (2 353 | ) | -473 | ||||
| Clinical expenses | (2 706 | ) | (1 053 | ) | |||
| Manufacturing expenses | (4 760 | ) | -460 | ||||
| Quality assurance and regulatory expenses | (1 463 | ) | -227 | ||||
| Patents fees & Related | (1 062 | ) | -123 | ||||
| Therapy development expenses | (3 599 | ) | (1 864 | ) | |||
| Other operating income / (expenses) | 265 | 459 | |||||
| Operating loss for the period | (26 242 | ) | (11 224 | ) | |||
| Financial income | 3 675 | 62 | |||||
| Financial expense | (2 072 | ) | -990 | ||||
| Loss for the period before taxes | (24 639 | ) | (12 152 | ) | |||
| Income taxes | (2 980 | ) | -93 | ||||
| Loss for the period | (27 619 | ) | (12 245 | ) | |||
| Loss attributable to equity holders | (27 619 | ) | (12 245 | ) | |||
| Other comprehensive income/(loss) | |||||||
| Items that may not be subsequently reclassified to profit or loss (net of tax) | |||||||
| Remeasurements of post-employment benefit obligations, net of tax | -68 | - | |||||
| Items that may be subsequently reclassified to profit or loss (net of tax) | |||||||
| Currency translation differences | 121 | -58 | |||||
| Total other comprehensive income/(loss) | 53 | -58 | |||||
| Total comprehensive loss for the year, net of tax | (27 566 | ) | (12 303 | ) | |||
| Loss attributable to equity holders | (27 566 | ) | (12 303 | ) | |||
| Basic loss per share (in EUR) | -1.16 | -0.68 | |||||
| Diluted loss per share (in EUR) | -1.16 | -0.68 |
REGULATED INFORMATION
| CONSOLIDATED BALANCE SHEETS |
| (in thousands) |
| As at December 31 | ||||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Property, plant and equipment | 2 020 | 713 | ||||||
| Intangible assets | 25 322 | 15 853 | ||||||
| Right of use assets | 3 218 | 3 283 | ||||||
| Deferred tax asset | 46 | 32 | ||||||
| Other long-term receivables | 164 | 91 | ||||||
| 30 770 | 19 972 | |||||||
| Current assets | ||||||||
| Inventory | 346 | 55 | ||||||
| Trade receivables | 226 | - | ||||||
| Other receivables | 2 286 | 1 644 | ||||||
| Other current assets | 1 693 | 109 | ||||||
| Cash and cash equivalents | 135 509 | 92 300 | ||||||
| 140 060 | 94 108 | |||||||
| Total assets | 170 830 | 114 080 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Capital and reserves | ||||||||
| Capital | 4 427 | 3 796 | ||||||
| Share premium | 228 033 | 150 936 | ||||||
| Share based payment reserve | 3 127 | 2 650 | ||||||
| Other comprehensive income | 202 | 149 | ||||||
| Retained loss | (87 167 | ) | (60 341 | ) | ||||
| Total equity attributable to shareholders | 148 622 | 97 190 | ||||||
| LIABILITIES | ||||||||
| Non-current liabilities | ||||||||
| Financial debt | 7 802 | 7 607 | ||||||
| Lease liability | 2 737 | 2 844 | ||||||
| Pension liability | 80 | 37 | ||||||
| Provisions | 12 | - | ||||||
| Deferred tax liability | 5 | - | ||||||
| 10 636 | 10 488 | |||||||
| Current liabilities | ||||||||
| Financial debt | 554 | 616 | ||||||
| Lease liability | 582 | 473 | ||||||
| Trade payables | 3 995 | 1 190 | ||||||
| Current tax liability | 2 808 | - | ||||||
| Other payables | 3 633 | 4 123 | ||||||
| 11 572 | 6 402 | |||||||
| Total liabilities | 22 208 | 16 890 | ||||||
| Total equity and liabilities | 170 830 | 114 080 |
REGULATED INFORMATION
for the twelve months ending December 31, 2021, compared to 69,000 for the twelve months ending December 31, 2020. The increase
in revenue was attributable to the Company's commercialization of the Genio system, primarily in Germany. Revenue for the
second half of 2021 was 497,000, a 40.0% increase versus the first half of the year despite COVID-related headwinds during the
was 303,000 for the twelve months ending December 31, 2021, representing a gross profit of 549,000, or gross margin of 64.4%.
This compares to total costs of goods sold of 30,000 in the 2020, for a gross profit of 39,000, or gross margin of 56.5%.
Administrative Expenses
General and administrative
expenses rose to 11.1 million for the full year ending December 31, 2021, from 7.5 million in the prior year. 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 U.S. commercial launch.
Development Expenses
Research and Development
expenses were 2.4 million for the twelve months ending December 31, 2021, a substantial increase over the 0.5 million for
the prior year, reflecting the ongoing research and development activities, most notably the development of next generation versions
of the Genio system. As of January 2021, the Company started to amortize its intangible assets, which explains the significant increase
in depreciation expenses for the twelve months ending December 31, 2021, compared to the twelve months ending December 31, 2020.
increased to 2.7 million for the twelve months ending December 31, 2021, from 1.1 million for the twelve months ending December
31, 2020. Total clinical expenses were 9.5 million, of which 6.8 million was capitalized, reflecting 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 the United States.
Manufacturing expenses
increased to 4.8 million for the twelve months ending December 31, 2021, from 0.5 million for the twelve months ending December
30, 2020, due mainly to increased demand for our Genio system for both commercial and non-commercial purposes.
REGULATED INFORMATION
and Regulatory Expenses
and regulatory expenses of 1.5 million for the year ending December 31, 2021, were up significantly from 0.2 million for
the year ending December 31, 2020, to support the scale-up of operations.
related expenses increased from 0.1 million for the twelve months ending December 31, 2020, to 1.1 million for the twelve
months ending December 31, 2021, due to expenses related to the exclusive licensing agreement with Vanderbilt University.
expenses were 3.6 million for the twelve months ending December 31, 2021, versus 1.9 million for the twelve months ending
December 31, 2020. The increase in expenses was mainly driven by the scale-up of commercial operations in Europe.
The Company realized
a net loss of 27.6 million for the full year ending December 31, 2021, compared to a net loss of 12.2 million for the full
year ending December 31, 2020, due to increases of activities in all departments.
Cash and cash equivalents
totaled 135.5 million on December 31, 2021, as compared to 92.3 million on December 31, 2020. The increase was due primarily
to total gross proceeds of $97.8 million generated from the July 2021 IPO.
operations was 25.3 million for the twelve months ending December 31, 2021, compared to 6.9 million for the twelve months
ending December 31, 2020. The increase was primarily due to an increase in net loss for the period 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 of 1.1 million.
investing activities was 11.8 million for the twelve months ending December 31, 2021, compared 10.7 million for the twelve
months ending December 31, 2020.
in financing activities for the twelve months ending December 31, 2021, was 76.5 compared to 104.0 million of net cash provided
by financing activities during the twelve months ending December 31, 2020.
REGULATED INFORMATION
business, operational, and clinical outlook for 2022 include the following expected milestones and goals:
financial report for the full year 2021, including details of the audited consolidated results, are available on the investor page of
Nyxoah's website (https://investors.nyxoah.com/financials).
and webcast presentation
a conference call to open to the public tomorrow, March 25, 2022, at 1:00 p.m. CET / 8:00 a.m. ET, which will also be webcasted. To participate
in the conference call, please dial one of the following numbers:
| 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.
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