Nyxoah SA — FY2021 Form 20-F summary
Reporting period: Fiscal year ended December 31, 2021, compared primarily with FY2020. This annual filing does not provide a standalone Q4 income statement or quarterly financial results. Financial statements are in euros and prepared under IFRS as issued by the IASB; audited by EY.
Business context
Nyxoah is a Belgian medical-device company developing and commercializing the Genio system, an implantable, battery-free hypoglossal nerve stimulation therapy for moderate-to-severe obstructive sleep apnea (OSA). Genio was CE-marked in Europe and commercial sales began in Germany in July 2020. The United States had not authorized the product for commercial sale as of the filing.
Key financial metrics
| Metric | FY2021 | FY2020 |
|---|---|---|
| Revenue | €0.852 million | €0.069 million |
| Cost of goods sold | €0.303 million | €0.030 million |
| Gross profit / gross margin | €0.549 million / approximately 64% | €0.039 million / approximately 57% |
| Operating loss | €26.242 million | €11.224 million |
| Net loss | €27.619 million | €12.245 million |
| Basic and diluted loss per share | €1.161 | €0.677 |
| Net cash used in operating activities | €25.336 million | €6.864 million |
| Net cash used in investing activities | €11.817 million | €10.693 million |
| Net cash from financing activities | €76.472 million | €104.025 million |
Revenue increased substantially from a small base as commercialization expanded, with 2021 sales reported in Germany (€0.8 million), Spain (€24,000) and Belgium (€20,000). Five customers each represented more than 10% of revenue in 2021. Despite higher sales, Nyxoah remained pre-profit and operating cash use increased with research, clinical, manufacturing and commercial investment.
At year-end, cash and cash equivalents were €135.509 million, versus €92.300 million in 2020. Current assets were €140.060 million and current liabilities €11.572 million. Financial debt was €8.356 million (€7.802 million non-current); lease liabilities were €3.319 million. The filing also reports €8.127 million of recoverable cash advances from the Walloon Region within financial debt. Accumulated deficit was €87.167 million. No cash dividends have been paid or are anticipated in the foreseeable future.
Material changes and notable items
- Revenue rose by €783,000 year over year, while operating loss widened by €15.018 million and net loss by €15.374 million.
- Research and development, clinical, manufacturing, quality/regulatory, patent and therapy-development costs all increased. Capitalized development spending was €10.348 million in 2021; intangible assets were €25.322 million at year-end.
- FY2021 financial income of €3.675 million was mainly foreign-exchange gains from revaluation of the U.S.-dollar cash balance. Financial expense was €2.072 million, including €882,000 accretion of interest on recoverable cash advances and a €316,000 fair-value loss on foreign-currency options.
- Income tax expense was €2.980 million, including a €2.6 million liability for uncertain tax positions in a jurisdiction where the company operates.
- Capital expenditure was €11.817 million, mainly for laboratory equipment, clean-room construction and capitalized development. The July 2021 Nasdaq offering generated approximately €75.0 million net proceeds.
- A €3.7 million variable compensation payment to ActuaRisk Consulting, a related party that had provided CFO services, was invoiced and paid in July 2021 under an existing IPO-related arrangement. The filing also reports €1.9 million of 2021 expense related to a cash-settled share-based payment transaction.
- Shares outstanding at December 31, 2021 were 25,772,359. The Nasdaq offering and warrant exercises increased share count during the year.
Outlook, progress and principal risks
- Management expected year-end cash, under its operating plan, to fund operations until Q1 2024. Separately, the audited financial statements state that cash was expected to fund operations for at least 12 months from their March 24, 2022 issuance. These are management estimates, not assurances; spending and financing needs may differ.
- The DREAM pivotal U.S. trial was intended to support a U.S. marketing application. Twenty-six participants had been implanted by December 2021, and 15 of 25 identified centers were active and enrolling. The filing gives differing expected timing for initial 12-month results: elsewhere it cites Q4 2022, Q2 2023 and the first half of 2023. It anticipated U.S. commercial availability in the first half of 2024 only if results and authorization were favorable.
- In October 2021, the company received a CE-mark indication expansion for patients with complete concentric collapse (CCC), based on initial BETTER SLEEP trial evidence. Initial six-month results included 23 responders among 36 evaluable patients; final independent review and adjudication were still pending. The FDA also granted breakthrough-device designation for treatment of OSA with CCC.
- Germany had reimbursement under a dedicated DRG code; Switzerland had reimbursement under an OSA-specific DRG code. The company began marketing in Switzerland and reported first revenue in Spain; it planned entry into the Netherlands and Finland in 2022. Reimbursement and market uptake elsewhere remained uncertain.
- The company reported ongoing COVID-19-related clinical enrollment and center-activation delays, including reduced elective procedures, travel constraints and hospital resource pressures. It also cited dependence on single-source suppliers, manufacturing scale-up, regulatory approval and reimbursement, competition, product safety and clinical outcomes, and the need for possible future financing.
- Two material weaknesses in internal control over financial reporting—insufficient technical accounting and supervisory capacity, and inadequate procedures for timely preparation and review—remained unremediated at December 31, 2021. Management said remediation was underway; disclosure controls were assessed as ineffective.
- The CE mark required transition to EU Medical Device Regulation requirements and re-certification before March 2024. The company also identified foreign-exchange exposure and did not generally hedge operational currency risk, although it had entered into currency options for certain forecast exposures.
Most important facts for investors to verify
- Whether DREAM trial enrollment, data timing, safety and efficacy support a U.S. filing, and which of the filing’s inconsistent result timelines is operative.
- Actual cash burn and updated runway relative to the Q1 2024 estimate; expected clinical, manufacturing and commercialization spending and any additional financing needs.
- Commercial sales, customer concentration, pricing, reimbursement coverage and adoption trends as the company expands beyond Germany.
- Final BETTER SLEEP results and adverse-event adjudication, plus ongoing Genio safety, reliability, manufacturing capacity and supplier continuity.
- Progress in remediating internal-control weaknesses and the basis, status and potential resolution of the €2.6 million uncertain-tax-position liability.
- EU MDR re-certification progress, and the extent and economics of Walloon Region advance repayments and Vanderbilt license royalties or milestones.