Nyxoah SA — FY2022 Form 20-F
Reporting period: Fiscal year ended December 31, 2022; filed March 22, 2023. This is an annual report, not a standalone Q4 report. Financial statements are audited and prepared under IFRS as issued by the IASB; amounts below are in euros unless stated otherwise.
Business context
Nyxoah is a Belgian medical-technology company developing and commercializing the Genio system, an implantable, battery-free hypoglossal nerve stimulation device for moderate-to-severe obstructive sleep apnea (OSA). Genio was its only commercial product, sold in select European markets. The company had CE marking in Europe but no U.S. marketing authorization; it was pursuing U.S. approval through clinical trials.
Financial results and liquidity
| Metric (€ millions, except per-share data) | 2022 | 2021 | Change |
|---|---|---|---|
| Revenue | 3.084 | 0.852 | +262% |
| Cost of goods sold | 1.150 | 0.303 | +280% |
| Gross profit / margin | 1.934 / 62.7% | 0.549 / 64.4% | Margin down about 1.7 pts |
| Research and development expense | 15.861 | 12.344 | +28% |
| Selling, general and administrative expense | 18.855 | 14.712 | +28% |
| Operating loss | (32.499) | (26.242) | Loss widened 24% |
| Net loss | (31.225) | (27.619) | Loss widened 13% |
| Basic and diluted loss per share | (€1.209) | (€1.161) | Loss per share increased |
| Net cash used in operating activities | (28.756) | (25.336) | Use increased €3.420m |
Revenue growth reflected broader European commercialization, including Germany, Switzerland, Spain and Finland. Germany contributed €2.8 million of 2022 revenue. Despite higher sales, the company remained loss-making and operating cash flow was negative. Reported financial income was €6.763 million, including €6.041 million of foreign-exchange gains, primarily from revaluation of U.S.-dollar cash and deposits; financial expense was €4.320 million, including a €2.721 million fair-value adjustment related to foreign-currency options and €0.925 million of accretion on recoverable advances.
At year-end, cash and cash equivalents were €17.888 million and current financial assets, principally term deposits, were €76.968 million, for combined cash and deposits of about €94.9 million. Total assets were €146.071 million; equity was €120.324 million; accumulated deficit was €118.212 million. Financial debt was €8.577 million, largely Walloon Region recoverable cash advances; lease liabilities were €3.305 million. Trade payables were €4.985 million and other payables €5.167 million.
Investing cash outflow was €89.946 million, principally reflecting term-deposit purchases; financing cash outflow was €0.983 million. The company capitalized €15.463 million of development costs in 2022 and reported intangible assets of €39.972 million, largely Genio development costs. Management stated that available cash and financial assets were expected to fund operations for at least 12 months from the financial-statement authorization date. Elsewhere, the filing’s risk discussion estimated runway through Q2 2024; these are different stated horizons and should be reconciled.
Material changes and operating developments
- Revenue rose substantially from a small base, while operating costs and operating cash use also increased as the company expanded clinical, R&D, manufacturing and commercial activities.
- Clinical expenses rose to €8.568 million from €3.923 million, reflecting DREAM trial activity, BETTER SLEEP follow-up, EliSA recruitment and launch of the ACCCESS trial.
- Cash and cash equivalents fell from €135.509 million to €17.888 million, while €76.968 million was held in current financial assets. The change primarily reflects investment of excess cash in term deposits as well as operating outflows.
- Genio 2.1 received CE marking in July 2022 and FDA authorization for use in the DREAM trial. The FDA also approved an IDE for the ACCCESS trial in 2022.
- Shares outstanding were 25,846,279 at December 31, 2022. A $50 million at-the-market offering program was established in December 2022 under a shelf registration statement permitting up to $200 million of securities; the filing does not report ATM sales during 2022.
Outlook, risks and unusual items
- U.S. pathway: All 115 DREAM trial participants had been implanted by the filing date. Nyxoah expected 12-month data in early 2024; a U.S. marketing application and possible commercial launch in the second half of 2024 were conditional on favorable results and FDA authorization. Early data cited in the filing were preliminary, not conclusive, and the trial’s specified responder threshold was at least 63%.
- Further trials: ACCCESS was planned to evaluate Genio in patients with CCC; the filing states that initial subjects had been implanted. EliSA was a European post-market follow-up study. The company expected continued clinical and R&D investment and losses for the foreseeable future.
- Commercialization and reimbursement: Revenue depended on uptake of Genio, physician and patient acceptance, reimbursement, and continued market access. Reimbursement coverage existed in Germany and Switzerland; the filing described limited commercial revenue overall.
- Regulatory and product risks: U.S. approval remained uncertain. Clinical outcomes, adverse events, manufacturing quality, supplier concentration and capacity, and transition to European MDR requirements could affect approvals or sales. Genio was the company’s only commercial product.
- Funding and liquidity: Management’s runway assessment depends on spending, clinical progress, commercialization and financing assumptions. Additional financing may be needed; equity issuance could dilute shareholders. The filing also discusses potential financial-institution and counterparty liquidity risks.
- Internal controls: Management concluded disclosure controls and internal control over financial reporting were ineffective at December 31, 2022. Two previously identified material weaknesses—insufficient technical accounting and supervisory staffing, and inadequate procedures and IT general controls for timely financial reporting—remained unremediated. The auditor did not attest to internal-control effectiveness.
- Unusual accounting and concentration: Foreign-exchange movements materially affected reported financial income, and recoverable cash advances require estimates of future sales and repayment timing. The filing reports five customers with individual sales “larger than 39%” of total revenue; that wording is unclear and should be checked against the underlying disclosure.
- Other: No material legal proceedings or post-balance-sheet events were reported. Nyxoah had never paid cash dividends and did not expect to do so in the foreseeable future.
Key facts investors should verify
- Reconcile the stated cash runway through Q2 2024 with management’s separate statement of at least 12 months of funding from the March 2023 filing date, including cash versus term-deposit availability and assumptions.
- Confirm DREAM trial endpoints, the ≥63% responder threshold, timing and final results; distinguish preliminary results from validated data and any eventual FDA decision.
- Verify the customer concentration disclosure, especially the unclear “five customers with individual sales larger than 39%” statement, and assess revenue concentration by geography and customer.
- Track reimbursement, sales growth and gross margin as commercialization expands, and compare realized unit economics with the company’s cost-reduction expectations.
- Review cash burn, clinical and capitalized development spending, ATM usage or other financing, recoverable-advance repayment assumptions, and potential dilution.
- Monitor remediation of the disclosed material weaknesses and any subsequent auditor or management findings.