Nyxoah Reports Fourth Quarter and Financial Year 2023 Financial and Operating Results
Nyxoah Reports Fourth Quarter and Financial Year 2023 Financial and Operating Results
Expect to report DREAM U.S. pivotal study efficacy and safety data by early April
Achieved record quarterly sales of 1.8 million
Mont-Saint-Guibert, Belgium March 5, 2024 10:05pm CET / 4:05pm 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 fourth quarter and financial year 2023.
Recent Financial and Operating Highlights
- Filed the third out of four modules in the U.S. modular PMA submission.
- Achieved quarterly sales of 1.8 million, representing sequential quarterly growth of 87% and increasing 42% year-over-year.
- Achieved 2023 full year sales of 4.3 million, representing 41% year-over-year growth.
- Ended the year with 48 active German accounts, up from 38 entering 2023.
- Total cash position of 57.7 million at the end of 2023.
2024 Strategic Priorities
- Complete patient follow up in the DREAM U.S. pivotal study and report efficacy and safety data by early April.
- File the fourth and final module in the modular PMA submission.
- Accelerate investments in the U.S. commercial organization in preparation for a late 2024 launch.
- Complete enrollment in the ACCCESS complete concentric collapse (CCC) U.S. pivotal study.
- Increase hypoglossal nerve stimulation (HGNS) market penetration and Genio market share in Europe.
In 2023, we completed enrollment in our DREAM U.S. pivotal study, presented positive early DREAM efficacy and safety data, initiated enrollment in our ACCCESS U.S. pivotal study for complete concentric collapse and raised capital from both existing and new investors. These accomplishments strengthen our confidence for a transformational 2024. commented Olivier Taelman, Nyxoah Chief Executive Officer. We are excited to report DREAM data in the coming weeks, finalize the regulatory FDA submission and pave the way for bringing Genio® to patients in the U.S.
Mr. Taelman continued, Commercially in Europe, this quarters performance was the strongest in Nyxoahs history driven by a targeted direct-to-consumer (DTC) effort and I applaud our European commercial team for their execution. I look forward to a further increase in therapy penetration from our partnership with ResMed in Germany.
Fourth Quarter and Full Year 2023 Results
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS FOR THE THREE MONTHS AND YEARS ENDED DECEMBER 31, 2023 AND DECEMBER 31, 2022 (in thousands)
| For the three months ended December 31, | For the year ended December 31, | ||||||
| 2023 | 2022 | 2023 | 2022 | ||||
| Revenue | 1,824 | 1,307 | 4,348 | 3,084 | |||
| Cost of goods sold | (726) | (465) | (1,656) | (1,150) | |||
| Gross profit | 1,098 | 842 | 2,692 | 1,934 | |||
| Research and Development Expense | (7,321) | (4,575) | (26,651) | (15,861) | |||
| Selling, General and Administrative Expense | (4,893) | (5,363) | (21,687) | (18,855) | |||
| Other income/(expense) | 279 | 46 | 544 | 283 | |||
| Operating loss for the period | (10,837) | (9,050) | (45,102) | (32,499) | |||
| Financial income | 582 | (4,609) | 4,174 | 6,763 | |||
| Financial expense | (964) | 1,153 | (3,729) | (4,320) | |||
| Loss for the period before taxes | (11,219) | (12,506) | (44,657) | (30,056) | |||
| Income taxes | 326 | (790) | 1,445 | (1,169) | |||
| Loss for the period | (10,893) | (13,296) | (43,212) | (31,225) | |||
| Loss attributable to equity holders | (10,893) | (13,296) | (43,212) | (31,225) | |||
| 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 | 81 | 70 | 81 | 70 | |||
| Items that may be subsequently reclassified to profit or loss (net of tax) | |||||||
| Currency translation differences | (32) | (82) | (120) | (96) | |||
| Total other comprehensive income/(loss) | (39) | (12) | (39) | (26) | |||
| Total comprehensive loss for the year, net of tax | (10,844) | (13,308) | (43,251) | (31,251) | |||
| Loss attributable to equity holders | (10,844) | (13,308) | (43,251) | (31,251) | |||
| Basic loss per share (in EUR) | (379) | (514) | (1,545) | (1,209) | |||
| Diluted loss per share (in EUR) | (379) | (514) | (1,545) | (1,209) | |||
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS OF DECEMBER 31, 2023 AND DECEMBER 31, 2022 (in thousands)
| As at December 31 | |||
| 2023 | 2022 | ||
| ASSETS | |||
| Non-current assets | |||
| Property, plant and equipment | 4,188 | 2,460 | |
| Intangible assets | 46,608 | 39,972 | |
| Right of use assets | 3,788 | 3,159 | |
| Deferred tax asset | 56 | 47 | |
| Other long-term receivables | 1,166 | 173 | |
| 55,806 | 45,811 | ||
| Current assets | |||
| Inventory | 3,315 | 882 | |
| Trade receivables | 2,758 | 1,463 | |
| Other receivables | 3,212 | 1,775 | |
| Other current assets | 1,318 | 1,284 | |
| Financial assets | 36,138 | 76,968 | |
| Cash and cash equivalents | 21,610 | 17,888 | |
| 68,351 | 100,260 | ||
| Total assets | 124,157 |
Mais notícias | |