Results of operation | 22. Revenue and cost of goods sold In the six months ended June 30, 2023, the Company generated revenue for the amount of €1.5 million (2022: €1.6 million). In the three months ended June 30, 2023, the Company generated revenue for the amount of €1.1 million (2022: €0.9 million). Revenue is recognized at a point in time upon satisfaction of the performance obligation, being the moment control over the Genio ® ® ® ® For the six month period ended June 30, 2023 the sales (based on country of customer) were generated in Germany (€1.4 million), Switzerland (€117,000) and Austria (€81,000) (2022: Germany: €1.6 million and Finland: €40,000). For the six month period ended June 30, 2023, the Company has no customers with individual sales larger than 10% of the total revenue (2022: two customers). For the three month period ended June 30, 2023 the sales (based on country of customer) were generated in Germany (€1.0 million), Switzerland (€23,000) and Austria (€41,000) (2022: Germany: €0.9 million). Cost of goods sold for the three and six months ended June 30, 2023 and 2022: For the three months ended For the six months ended June 30 June 30 (in EUR 000) 2023 2022 2023 2022 Purchases of goods and services 316 539 858 783 Inventory movement 103 (205) (264) (160) Total cost of goods sold 419 334 594 623 Operating expenses The tables below detail the operating expenses for the six months ended June 30, 2023 and 2022: Operating expense for the (in EUR 000) Total cost Capitalized period Research and development 17,763 (5,001) 12,762 Selling, general and administrative expenses 11,736 — 11,736 Other income and expenses (273) 8 (265) For the six months ended June 30, 2023 29,226 (4,993) 24,233 Operating expense for the (in EUR 000) Total cost Capitalized period Research and development 14,817 (7,752) 7,065 Selling, general and administrative expenses 8,729 — 8,729 Other income and expenses (252) 102 (150) For the six months ended June 30, 2022 23,294 (7,650) 15,644 The tables below detail the operating expenses for the three months ended June 30, 2023 and 2022: Operating expense for the (in EUR 000) Total cost Capitalized period Research and development 8,892 (2,287) 6,605 Selling, general and administrative expenses 6,185 — 6,185 Other income and expenses (227) 8 (219) For the three months ended June 30, 2023 14,850 (2,279) 12,571 Operating expense for the (in EUR 000) Total cost Capitalized period Research and development 7,776 (4,306) 3,470 Selling, general and administrative expenses 4,536 — 4,536 Other income and expenses (83) 69 (14) For the three months ended June 30, 2022 12,229 (4,237) 7,992 Research and Development expenses For the three months ended For the six months ended June 30 June 30 (in EUR 000) 2023 2022 2023 2022 Staff costs 3,386 2,595 7,381 5,090 Consulting and contractors' fees 890 612 1,694 1,304 Q&A regulatory 109 52 145 125 IP costs 112 120 241 222 Depreciation and amortization expense 318 245 631 496 Travel 292 206 572 328 Manufacturing and outsourced development 1,942 892 3,127 2,341 Clinical studies 1,190 2,642 2,567 4,252 Other expenses 292 410 723 657 IT 361 2 682 2 Capitalized costs (2,287) (4,306) (5,001) (7,752) Total research and development expenses 6,605 3,470 12,762 7,065 Before capitalization of €5.0 million for the six months ended June 30, 2023 and €7.8 million for the six months ended June 30, 2022, research and development expenses increased by €3.0 million or 20 %, from €14.8 million for the six months ended June 30, 2022, to €17.8 million for the six months ended June 30, 2023, due to the combined effect of higher clinical, R&D activities and manufacturing expenses and also due to a start of new ERP system implementation. This increase is mainly in staff, consulting costs and in manufacturing and outsourced development to support those activities, this increase was offset by a decrease of €1.7 million in clinical study activities due to Dream Study. Before capitalization of €2.3 million for the three months ended June 30, 2023 and €4.3 million for the three months ended June 30, 2022, research and development expenses increased by €1.1 million or 14 %, from €7.8 million for the three months ended June 30, 2022, to €8.9 million for the three months ended June 30, 2023, due to the combined effect of higher clinical, R&D activities and manufacturing expenses and also due to a start of new ERP system implementation. This increase is mainly in staff and consulting costs to support those activities and manufacturing and outsourced development. Selling, General and Administrative expenses For the three months ended For the six months ended June 30 June 30 (in EUR 000) 2023 2022 2023 2022 Staff costs 2,390 1,647 4,802 3,329 Consulting and contractors' fees 2,279 1,104 3,857 2,104 Legal fees 257 181 485 415 Rent 107 127 195 202 Depreciation and amortization expense 242 229 484 440 IT 240 153 488 253 Travel 187 267 430 547 Insurance fees 289 427 576 835 Other 194 401 419 604 Total selling, general and administrative expenses 6,185 4,536 11,736 8,729 Selling, general and administrative expenses increased by €3.0 million or 34 % from €8.7 million for the six months ended June 30, 2022 to €11.7 million for the six months ended June 30, 2023, mainly due to an increase of costs to support the commercialization of Genio(R) system in Europe, scale up of the Company and also due to a start of new ERP system implementation. Selling, general and administrative expenses increased by €1.6 million or 36 % from €4.5 million for the three months ended June 30, 2022 to €6.2 million for the three months ended June 30, 2023, mainly due to an increase of costs to support the commercialization of Genio(R) system in Europe, scale up of the Company and also due to a start of new ERP system implementation. Other operating income / ( expenses) For the three months ended For the six months ended June 30 June 30 (in EUR 000) 2023 2022 2023 2022 Recoverable cash advances Initial measurement and re-measurement 6 11 39 28 R&D incentives (Australia) 268 41 289 137 Capitalization of R&D incentive (8) (69) (8) (102) Other income/(expenses) (47) 31 (55) 87 Total Other Operating Income/(Expenses) 219 14 265 150 The Company had other operating income of €265,000 for the six months ended June 30, 2023 compared to other operating expenses of €150,000 for the six months ended June 30, 2022. The Company had other operating income of €219,000 for the three months ended June 30, 2023 compared to other operating expenses of €14,000 for the three months ended June 30, 2022. The other operating income contains the R&D Incentive (Australia) that relates to an incentive to be received on development expenses incurred by the subsidiary in Australia. The R&D incentive for the period of six months ended June 30, 2023 includes a correction for 2022. |