{"id":76918,"date":"2022-11-09T05:15:55","date_gmt":"2022-11-09T05:15:55","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=101888"},"modified":"2022-11-09T05:15:55","modified_gmt":"2022-11-09T05:15:55","slug":"nyxoah-reports-third-quarter-2022-financial-and-operating-results","status":"publish","type":"post","link":"https:\/\/kuwaitnewsgazette.com\/nyxoah-reports-third-quarter-2022-financial-and-operating-results\/","title":{"rendered":"Nyxoah Reports Third Quarter 2022 Financial and Operating Results"},"content":{"rendered":"
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REGULATED INFORMATION<\/strong><\/p>\nNyxoah <\/strong>Reports<\/strong> Third Quarter<\/strong> 202<\/strong>2<\/strong> Financial<\/strong> and Operating<\/strong> Results<\/strong><\/p>\nDREAM US pivotal<\/em> 12-month clinical data <\/em>expected <\/em>in <\/em>fall of 2023<\/em><\/p>\nMont-Saint-Guibert, Belgium \u2013<\/strong> November<\/strong> 8<\/strong>, <\/strong>202<\/strong>2<\/strong>, <\/strong>10<\/strong>:<\/strong>05<\/strong>pm <\/strong>CET \/ <\/strong>4<\/strong>:<\/strong>05<\/strong>pm <\/strong>ET<\/strong> \u2013 Nyxoah <\/strong>SA (<\/strong>Euronext Brussels\/Nasdaq<\/strong>: NYXH)<\/strong> (\u201cNyxoah\u201d or the \u201cCompany\u201d), 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 quarter ended September 30, 2022.<\/p>\nThird<\/strong> Quarter<\/strong> 2022 Financial and<\/strong> Operati<\/strong>ng<\/strong> Highlights<\/strong><\/p>\n\n- Completed 110 of 115 implants in the DREAM U.S. pivotal trial to date, with 12-month clinical data expected in the fall of 2023 and regulatory approval in the second quarter of 2024<\/li>\n
- Activated the first clinical sites in the ACCCESS U.S. pivotal trial to treat complete concentric collapse (CCC) patients in the U.S., with first implants expected in the fourth quarter of 2022<\/li>\n
- Reported revenue of \u20ac182,000 from the commercialization of Genio\u00ae; sales during the third quarter were impacted by a temporary inventory shortage in Germany due to a disruption at a component supplier, resulting in unfulfilled third quarter orders of approximately \u20ac700,000 in Germany; this supply disruption has subsequently been remedied and the vast majority of the open orders have since been filled<\/li>\n
- Ended the third quarter with 32 active sites in Germany, up from 26 sites at the end of the second quarter 2022; expects to have up to 40 active sites by the end of 2022<\/li>\n
- Launched the \u201cCare4\u201d program, using the AcuPebble home sleep test at selected centers of excellence in Germany to accelerate the time from CPAP failure to our Genio solution<\/li>\n
- Received CE Mark for the next-generation Genio system, Genio 2.1<\/li>\n<\/ul>\n
\u201cWith 110 implants in the DREAM trial, we believe we are within weeks of completion of the implants, keeping us on track for 12-month data next fall,\u201d commented Olivier Taelman, Nyxoah\u2019s Chief Executive Officer. \u201cAdditionally, ACCCESS, our second US pivotal trial is launched, and first patients are expected to be implanted before year end. This trial is focused on addressing the unmet need of approximately 30% of OSA patients contra-indicated in the U.S. to hypoglossal nerve stimulation due to their complete concentric collapse.\u201d<\/p>\n
Mr. Taelman continued, \u201cCommercially in Germany, where we have both CCC and non-CCC indications already, we continue to build on our momentum, as patients and clinicians increasingly recognize the unique benefits of the Genio solution. While third quarter sales reflected a temporary supply disruption, the fourth quarter is off to a strong start, as we are filling both open orders from the third quarter and new ones. This gives us confidence that we can be the German market leader exiting 2022.\u201d<\/p>\n
Third<\/strong> Quarter<\/strong> 2022<\/strong> Results<\/strong><\/p>\nUNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION \u2013 INTERIM CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS\u202fFOR THE THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30,\u202f2022\u202f(in thousands)<\/strong><\/p>\n\n\n\n<\/td>\n | <\/td>\n | <\/td>\n | For the three months ended September 30<\/strong><\/td>\n<\/td>\n | For the nine months ended September 30<\/strong><\/td>\n<\/tr>\n\n<\/td>\n | <\/td>\n | <\/td>\n | 2022<\/strong><\/td>\n<\/td>\n | 2021<\/strong><\/td>\n<\/td>\n | 2022<\/strong><\/td>\n<\/td>\n | 2021<\/strong><\/td>\n<\/tr>\n\nRevenue<\/td>\n | <\/td>\n | <\/td>\n | \u20ac 182<\/td>\n | <\/td>\n | \u20ac 203<\/td>\n | <\/td>\n | \u20ac 1 777<\/td>\n | <\/td>\n | \u20ac 557<\/td>\n<\/tr>\n | \nCost of goods sold<\/td>\n | <\/td>\n | <\/td>\n | ( 63)<\/td>\n | <\/td>\n | ( 82)<\/td>\n | <\/td>\n | ( 685)<\/td>\n | <\/td>\n | ( 198)<\/td>\n<\/tr>\n | \nGross profit<\/strong><\/td>\n<\/td>\n | <\/td>\n | \u20ac 119<\/strong><\/td>\n<\/td>\n | \u20ac 121<\/strong><\/td>\n<\/td>\n | \u20ac 1 092<\/strong><\/td>\n<\/td>\n | \u20ac 359<\/strong><\/td>\n<\/tr>\n\nResearch and Development Expense<\/td>\n | <\/td>\n | <\/td>\n | (4 221)<\/td>\n | <\/td>\n | (3 517)<\/td>\n | <\/td>\n | (11 286)<\/td>\n | <\/td>\n | (9 009)<\/td>\n<\/tr>\n | \nSelling, General and Administrative Expense<\/td>\n | <\/td>\n | <\/td>\n | (4 763)<\/td>\n | <\/td>\n | (4 496)<\/td>\n | <\/td>\n | (13 492)<\/td>\n | <\/td>\n | (10 775)<\/td>\n<\/tr>\n | \nOther income\/(expense)<\/td>\n | <\/td>\n | <\/td>\n | 87<\/td>\n | <\/td>\n | ( 178)<\/td>\n | <\/td>\n | 237<\/td>\n | <\/td>\n | ( 274)<\/td>\n<\/tr>\n | \nOperating loss for the period<\/strong><\/td>\n<\/td>\n | <\/td>\n | \u20ac (8 778)<\/strong><\/td>\n<\/td>\n | \u20ac (8 070)<\/strong><\/td>\n<\/td>\n | \u20ac (23 449)<\/strong><\/td>\n<\/td>\n | \u20ac (19 699)<\/strong><\/td>\n<\/tr>\n\nFinancial income<\/td>\n | <\/td>\n | <\/td>\n | 5 127<\/td>\n | <\/td>\n | 29<\/td>\n | <\/td>\n | 11 372<\/td>\n | <\/td>\n | 72<\/td>\n<\/tr>\n | \nFinancial expense<\/td>\n | <\/td>\n | <\/td>\n | (2 524)<\/td>\n | <\/td>\n | ( 585)<\/td>\n | <\/td>\n | (5 473)<\/td>\n | <\/td>\n | (1 484)<\/td>\n<\/tr>\n | \nLoss for the period before taxes<\/strong><\/td>\n<\/td>\n | <\/td>\n | \u20ac (6 175)<\/strong><\/td>\n<\/td>\n | \u20ac (8 626)<\/strong><\/td>\n<\/td>\n | \u20ac (17 550)<\/strong><\/td>\n<\/td>\n | \u20ac (21 111)<\/strong><\/td>\n<\/tr>\n\nIncome taxes<\/td>\n | <\/td>\n | <\/td>\n | ( 65)<\/td>\n | <\/td>\n | ( 136)<\/td>\n | <\/td>\n | ( 379)<\/td>\n | <\/td>\n | ( 260)<\/td>\n<\/tr>\n | \nLoss for the period<\/strong><\/td>\n<\/td>\n | <\/td>\n | \u20ac (6 240)<\/strong><\/td>\n<\/td>\n | \u20ac (8 762)<\/strong><\/td>\n<\/td>\n | \u20ac (17 929)<\/strong><\/td>\n<\/td>\n | \u20ac (21 371)<\/strong><\/td>\n<\/tr>\n\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nLoss attributable to equity holders<\/strong><\/td>\n<\/td>\n | <\/td>\n | \u20ac (6 240)<\/strong><\/td>\n<\/td>\n | \u20ac (8 762)<\/strong><\/td>\n<\/td>\n | \u20ac (17 929)<\/strong><\/td>\n<\/td>\n | \u20ac (21 371)<\/strong><\/td>\n<\/tr>\n\nOther comprehensive loss<\/strong><\/td>\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nItems that may be subsequently reclassified to profit or loss (net of tax)<\/strong><\/td>\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nCurrency translation differences<\/td>\n | <\/td>\n | <\/td>\n | 100<\/td>\n | <\/td>\n | ( 54)<\/td>\n | <\/td>\n | ( 14)<\/td>\n | <\/td>\n | 138<\/td>\n<\/tr>\n | \nTotal comprehensive loss for the year, net of tax<\/strong><\/td>\n<\/td>\n | <\/td>\n | \u20ac (6 140)<\/strong><\/td>\n<\/td>\n | \u20ac (8 816)<\/strong><\/td>\n<\/td>\n | \u20ac (17 943)<\/strong><\/td>\n<\/td>\n | \u20ac (21 233)<\/strong><\/td>\n<\/tr>\n\nLoss attributable to equity holders<\/strong><\/td>\n<\/td>\n | <\/td>\n | \u20ac (6 140)<\/strong><\/td>\n<\/td>\n | \u20ac (8 816)<\/strong><\/td>\n<\/td>\n | \u20ac (17 943)<\/strong><\/td>\n<\/td>\n | \u20ac (21 233)<\/strong><\/td>\n<\/tr>\n\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nBasic Loss Per Share (in EUR)<\/td>\n | <\/td>\n | <\/td>\n | \u20ac (0.242)<\/td>\n | <\/td>\n | \u20ac (0.348)<\/td>\n | <\/td>\n | \u20ac (0.695)<\/td>\n | <\/td>\n | \u20ac (0.923)<\/td>\n<\/tr>\n | \nDiluted Loss Per Share (in EUR)<\/td>\n | <\/td>\n | <\/td>\n | \u20ac (0.242)<\/td>\n | <\/td>\n | \u20ac (0.348)<\/td>\n | <\/td>\n | \u20ac (0.695)<\/td>\n | <\/td>\n | \u20ac (0.923)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION \u2013 INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS AT SEPTEMBER 30, 2022 (in thousands)<\/strong><\/p>\n\n\n\n<\/td>\n | <\/td>\n | <\/td>\n | As at<\/strong><\/td>\n<\/tr>\n\n<\/td>\n | <\/td>\n | <\/td>\n | September 30<\/strong>,<\/strong> 2022<\/strong><\/td>\n<\/td>\n | December 31<\/strong>,<\/strong> 2021<\/strong><\/td>\n<\/tr>\n\nASSETS<\/strong><\/td>\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nNon-current assets<\/strong><\/td>\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nProperty, plant and equipment<\/td>\n | <\/td>\n | <\/td>\n | \u20ac 2 216<\/td>\n | <\/td>\n | \u20ac 2 020<\/td>\n<\/tr>\n | \nIntangible assets<\/td>\n | <\/td>\n | <\/td>\n | 36 488<\/td>\n | <\/td>\n | 25 322<\/td>\n<\/tr>\n | \nRight of use assets<\/td>\n | <\/td>\n | <\/td>\n | 3 413<\/td>\n | <\/td>\n | 3 218<\/td>\n<\/tr>\n | \nDeferred tax asset<\/td>\n | <\/td>\n | <\/td>\n | 2 423<\/td>\n | <\/td>\n | 46<\/td>\n<\/tr>\n | \nOther long-term receivables<\/td>\n | <\/td>\n | <\/td>\n | 188<\/td>\n | <\/td>\n | 164<\/td>\n<\/tr>\n | \n<\/td>\n | <\/td>\n | <\/td>\n | \u20ac 44 728<\/strong><\/td>\n<\/td>\n | \u20ac 30 770<\/strong><\/td>\n<\/tr>\n\nCurrent assets<\/strong><\/td>\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nInventory<\/td>\n | <\/td>\n | <\/td>\n | 594<\/td>\n | <\/td>\n | 346<\/td>\n<\/tr>\n | \nTrade receivables<\/td>\n | <\/td>\n | <\/td>\n | 757<\/td>\n | <\/td>\n | 226<\/td>\n<\/tr>\n | \nOther receivables<\/td>\n | <\/td>\n | <\/td>\n | 2 022<\/td>\n | <\/td>\n | 2 286<\/td>\n<\/tr>\n | \nOther current assets<\/td>\n | <\/td>\n | <\/td>\n | 587<\/td>\n | <\/td>\n | 1 693<\/td>\n<\/tr>\n | \nFinancial assets<\/td>\n | <\/td>\n | <\/td>\n | 25 505<\/td>\n | <\/td>\n | \u2212<\/td>\n<\/tr>\n | \nCash and cash equivalents<\/td>\n | <\/td>\n | <\/td>\n | 89 877<\/td>\n | <\/td>\n | 135 509<\/td>\n<\/tr>\n | \n<\/td>\n | <\/td>\n | <\/td>\n | \u20ac 119 342<\/strong><\/td>\n<\/td>\n | \u20ac 140 060<\/strong><\/td>\n<\/tr>\n\nTotal assets<\/strong><\/td>\n<\/td>\n | <\/td>\n | \u20ac 164 070<\/strong><\/td>\n<\/td>\n | \u20ac 170 830<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nEQUITY AND LIABILITIES<\/strong><\/td>\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nCapital and reserves<\/strong><\/td>\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nCapital<\/td>\n | <\/td>\n | <\/td>\n | 4 440<\/td>\n | <\/td>\n | 4 427<\/td>\n<\/tr>\n | \nShare premium<\/td>\n | <\/td>\n | <\/td>\n | 228 275<\/td>\n | <\/td>\n | 228 033<\/td>\n<\/tr>\n | \nShare based payment reserve<\/td>\n | <\/td>\n | <\/td>\n | 5 225<\/td>\n | <\/td>\n | 3 127<\/td>\n<\/tr>\n | \nOther comprehensive income<\/td>\n | <\/td>\n | <\/td>\n | 188<\/td>\n | <\/td>\n | 202<\/td>\n<\/tr>\n | \nRetained loss<\/td>\n | <\/td>\n | <\/td>\n | (105 058)<\/td>\n | <\/td>\n | (87 167)<\/td>\n<\/tr>\n | \nTotal equity attributable to shareholders<\/strong><\/td>\n<\/td>\n | <\/td>\n | \u20ac 133 070<\/strong><\/td>\n<\/td>\n | \u20ac 148 622<\/strong><\/td>\n<\/tr>\n\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nLIABILITIES<\/strong><\/td>\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nNon-current liabilities<\/strong><\/td>\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nFinancial debt<\/td>\n | <\/td>\n | <\/td>\n | 8 035<\/td>\n | <\/td>\n | 7 802<\/td>\n<\/tr>\n | \nLease liability<\/td>\n | <\/td>\n | <\/td>\n | 2 831<\/td>\n | <\/td>\n | 2 737<\/td>\n<\/tr>\n | \nPension liability<\/td>\n | <\/td>\n | <\/td>\n | 80<\/td>\n | <\/td>\n | 80<\/td>\n<\/tr>\n | \nProvisions<\/td>\n | <\/td>\n | <\/td>\n | 47<\/td>\n | <\/td>\n | 12<\/td>\n<\/tr>\n | \nDeferred tax liability<\/td>\n | <\/td>\n | <\/td>\n | \u2212<\/td>\n | <\/td>\n | 5<\/td>\n<\/tr>\n | \n<\/td>\n | <\/td>\n | <\/td>\n | \u20ac 10 993<\/strong><\/td>\n<\/td>\n | \u20ac 10 636<\/strong><\/td>\n<\/tr>\n\nCurrent liabilities<\/strong><\/td>\n<\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n | <\/td>\n<\/tr>\n | \nFinancial debt<\/td>\n | <\/td>\n | <\/td>\n | 656<\/td>\n | <\/td>\n | 554<\/td>\n<\/tr>\n | \nLease liability<\/td>\n | <\/td>\n | <\/td>\n | 722<\/td>\n | <\/td>\n | 582<\/td>\n<\/tr>\n | \nTrade payables<\/td>\n | <\/td>\n | <\/td>\n | 5 346<\/td>\n | <\/td>\n | 3 995<\/td>\n<\/tr>\n | \nCurrent tax liability<\/td>\n | <\/td>\n | <\/td>\n | 5 391<\/td>\n | <\/td>\n | 2 808<\/td>\n<\/tr>\n | \nOther payables<\/td>\n | <\/td>\n | <\/td>\n | 7 892<\/td>\n | <\/td>\n | 3 633<\/td>\n<\/tr>\n | \n<\/td>\n | <\/td>\n | <\/td>\n | \u20ac 20 007<\/strong><\/td>\n<\/td>\n | \u20ac 11 572<\/strong><\/td>\n<\/tr>\n\nTotal liabilities<\/strong><\/td>\n<\/td>\n | <\/td>\n | \u20ac 31 000<\/strong><\/td>\n<\/td>\n | \u20ac 22 208<\/strong><\/td>\n<\/tr>\n\nTotal equity and liabilities<\/strong><\/td>\n<\/td>\n | <\/td>\n | \u20ac 164 070<\/strong><\/td>\n<\/td>\n | \u20ac 170 830<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION – INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS AS AT SEPTEMBER 30, 2022 (in thousands)<\/strong><\/p>\n\n\n\n<\/td>\n | <\/td>\n | <\/td>\n | For the nine months ended September 30<\/strong><\/td>\n<\/tr>\n | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |