Nyxoah SA — FY2023 Form 20-F
Reporting period: Fiscal year ended December 31, 2023; filed March 20, 2024. This is an annual report, not a standalone fourth-quarter filing. Financial statements are in euros and prepared under IFRS.
Business context and reporting period
Nyxoah is a medical-technology company developing and commercializing the Genio system, an implantable hypoglossal nerve stimulation device for moderate-to-severe obstructive sleep apnea (OSA). Genio was commercially available in selected European markets; it was not authorized for sale in the United States at year-end. The company reported one operating segment and 28,673,985 ordinary shares outstanding at December 31, 2023.
Key financial metrics
| Metric (€, millions unless stated) | 2023 | 2022 |
|---|---|---|
| Revenue | 4.35 | 3.08 |
| Cost of goods sold | 1.66 | 1.15 |
| Gross profit / gross margin | 2.69 / approximately 62% | 1.93 / approximately 63% |
| Research and development expense | 26.65 | 15.86 |
| Selling, general and administrative expense | 21.69 | 18.86 |
| Operating loss | (45.10) | (32.50) |
| Net loss | (43.21) | (31.23) |
| Basic and diluted loss per share | €1.545 | €1.209 |
| Net cash used in operating activities | (44.78) | (28.76) |
| Capital expenditures | 10.5 | 16.3 |
At year-end, cash and cash equivalents were €21.6 million and current financial assets were €36.1 million, for combined cash and financial assets of €57.7 million. Total assets were €124.2 million, equity €98.0 million, and accumulated deficit €160.8 million. Financial debt had a carrying value of €8.7 million; lease liabilities were €4.0 million. The filing also presents undiscounted contractual financial-debt payments of €13.5 million. Operating cash outflow increased despite positive net cash from investing activities of €32.0 million, principally reflecting maturities of term deposits and investments. Financing activities provided €16.9 million, mainly from 2023 share issuances.
Material changes versus prior comparable period
- Revenue grew 41%, from €3.08 million to €4.35 million, as European commercialization expanded. Germany generated €3.82 million; Switzerland €0.37 million; Austria €0.12 million; and Spain €0.04 million.
- Gross profit rose 39%, but gross margin edged down to approximately 62% from 63%.
- Operating loss widened by €12.6 million. Reported R&D expense increased 68%, while G&A rose 15%; the company cited higher staffing, manufacturing and development activity, commercialization costs, and ERP implementation.
- Clinical-study expense declined to €4.9 million from €8.6 million, primarily following completion of DREAM trial enrollment. However, total R&D costs before capitalization increased; €8.5 million was capitalized in 2023 versus €15.6 million in 2022.
- Net loss increased 38%, and operating cash use rose by €16.0 million. Cash and current financial assets combined declined from €94.9 million to €57.7 million.
- The company raised approximately €18.3 million net from share issuances in 2023; shares outstanding increased from 25.85 million to 28.67 million.
Outlook, commentary, risks and unusual items
- Going concern and funding: Management estimated that year-end cash and financial assets would fund operations only until the beginning of Q4 2024. The auditor’s report and management disclosures state that substantial doubt exists about the company’s ability to continue as a going concern for at least 12 months from the filing date. Additional financing is not assured; management was exploring equity and debt options and said it believed funding would be achievable following the DREAM results.
- U.S. regulatory and commercial plans: On March 19, 2024, the company announced that the pivotal DREAM trial met its co-primary endpoints. It reported an intention to seek FDA marketing authorization, targeting U.S. commercial availability in late 2024, subject to FDA review and financing. The Genio system was not yet authorized in the U.S.
- DREAM results and safety: The company reported an intent-to-treat AHI responder rate of 63.5% (73 subjects; p=0.002) and ODI responder rate of 71.3% (82 subjects; p<0.001) at 12 months. It reported 11 serious adverse events in 10 subjects, an 8.7% SAE rate; three were device-related and three devices were explanted. The filing notes earlier 12-month data presented in 2023 were preliminary.
- Other clinical work: ACCCESS is evaluating Genio in OSA patients with complete concentric collapse; the company expected to complete implantations in late 2024. It also planned continued follow-up in other studies.
- Regulatory and commercial risks: European sales depend on maintaining certification and completing transition to the EU Medical Devices Regulation requirements. The company also faces reimbursement uncertainty, competition, dependence on limited or single-source suppliers, manufacturing scale-up risk, and clinical and regulatory execution risk.
- Internal controls: Management concluded disclosure controls and internal control over financial reporting were ineffective at December 31, 2023. Material weaknesses involved insufficient technical accounting and supervisory capacity, oversight of external advisers, and an incomplete risk-based control framework, including IT general controls. Remediation was ongoing; a new ERP system went live January 1, 2024.
- Unusual tax item: A €1.45 million income-tax benefit included reversal of a U.S. tax liability after a study concluded certain R&D costs could be deducted when incurred.
- Other contingencies: The company reported no material legal proceedings, product-liability claims, or warranty claims as of the filing date. It noted ongoing geopolitical risks given significant R&D and manufacturing operations and personnel in Israel.
Most important facts for investors to verify
- Whether Nyxoah secured sufficient financing to extend its runway beyond the disclosed beginning-of-Q4 2024 estimate, and the terms and dilution of any financing.
- FDA review progress, any additional evidence or conditions required, and the timing and scope of any U.S. marketing authorization.
- Final DREAM trial safety and efficacy data, including follow-up on device-related SAEs and explants.
- European sales growth, reimbursement coverage, gross-margin trajectory, and conversion of the growing inventory into sales.
- Progress remediating material weaknesses and whether controls operate effectively after ERP implementation.
- Cash burn, term-deposit maturities, debt repayments, and the assumptions underlying management’s runway estimate.