{"id":52477,"date":"2021-06-11T05:39:06","date_gmt":"2021-06-11T05:39:06","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=74907"},"modified":"2021-06-11T05:39:06","modified_gmt":"2021-06-11T05:39:06","slug":"nyxoah-issues-first-quarter-2021-results","status":"publish","type":"post","link":"https:\/\/lebanonnewsgazette.com\/nyxoah-issues-first-quarter-2021-results\/","title":{"rendered":"Nyxoah Issues First Quarter 2021 Results"},"content":{"rendered":"

Mont-Saint-Guibert, Belgium \u2013 June 10, 2021, 11:45pm CET \/ 5:45pm ET \u2013 Nyxoah SA (Euronext Brussels: NYXH)<\/b> (\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 announced its unaudited, interim financial statements for the three months ended March 31, 2021.\u00a0 In addition, Mr.\u00a0Janke Dittmer has informed the Company that he will resign from his position as director immediately prior to and contingent upon the completion of an initial public offering in the United States.<\/p>\n

First Quarter 2021 Results<\/b><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\u00a0<\/i><\/td>\nFor the\u00a0three month period\u00a0ended\u00a0March\u00a031<\/b><\/td>\n<\/tr>\n
(in thousands of EUR)<\/i><\/td>\n2021<\/b><\/td>\n2020<\/b><\/td>\n<\/tr>\n
Revenue<\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 185<\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u2014<\/td>\n<\/tr>\n
Cost of goods sold<\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (52)<\/td>\n\u2014<\/td>\n<\/tr>\n
Gross Profit<\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 1<\/b>33<\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u2014<\/td>\n<\/tr>\n
General and administrative expenses<\/td>\n(1,818)<\/td>\n(1,178)<\/td>\n<\/tr>\n
Research and development expenses<\/td>\n(852)<\/td>\n(7)<\/td>\n<\/tr>\n
Clinical expenses<\/td>\n(342)<\/td>\n(177)<\/td>\n<\/tr>\n
Manufacturing expenses<\/td>\n(901)<\/td>\n(62)<\/td>\n<\/tr>\n
Quality assurance and regulatory expenses<\/td>\n(325)<\/td>\n(25)<\/td>\n<\/tr>\n
Patents Fees & Related<\/td>\n(674)<\/td>\n(58)<\/td>\n<\/tr>\n
Therapy Development expenses<\/td>\n(548)<\/td>\n(352)<\/td>\n<\/tr>\n
Other operating income\/(expenses)<\/td>\n4<\/td>\n(191)<\/td>\n<\/tr>\n
Operating loss for the period<\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0\u00a0\u00a0\u00a0\u00a0 (5,323)<\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (2,050)<\/b><\/td>\n<\/tr>\n
Financial income<\/td>\n4<\/td>\n19<\/td>\n<\/tr>\n
Financial expense<\/td>\n(325)<\/td>\n(336)<\/td>\n<\/tr>\n
Loss for the period before taxes <\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (5,644)<\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (2,367)<\/b><\/td>\n<\/tr>\n
Income Taxes<\/td>\n(25)<\/td>\n(13)<\/td>\n<\/tr>\n
Loss for the period<\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (5,669)<\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (2,380)<\/b><\/td>\n<\/tr>\n
Other comprehensive loss<\/td>\n\u00a0<\/b><\/td>\n\u00a0<\/b><\/td>\n<\/tr>\n
Items that may be subsequently reclassified to profit or loss (net of tax)<\/td>\n\u00a0<\/b><\/td>\n\u00a0<\/b><\/td>\n<\/tr>\n
Currency translation differences<\/td>\n(70)<\/td>\n272<\/td>\n<\/tr>\n
Total comprehensive loss for the year, net of tax<\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (5,739)<\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (2,108)<\/b><\/td>\n<\/tr>\n
Loss attributable to equity holders<\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (5,739)<\/b><\/td>\n\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (2,108)<\/b><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\n

Revenue<\/i><\/p>\n

Revenue was \u20ac185,000 for the three months ended March 31, 2021, compared to no revenue for the three months ended March 31, 2020. The increase in revenue was attributable to the Company\u2019s commercialization of the Genio\u00ae system in Europe, which began in July 2020.<\/p>\n

Cost of Goods Sold<\/i><\/p>\n

Cost of goods sold was \u20ac52,000 for the three months ended March 31, 2021, compared to no cost for the three months ended March 31, 2020. The increase in cost of goods sold was attributable to the sales of the Genio\u00ae system in Europe, which began in July 2020.<\/p>\n

General and Administrative Expenses<\/i>. General and administrative expenses increased by \u20ac0.6 million, or 54%, from \u20ac1.2 million for the three months ended March 31, 2020 to \u20ac1.8 million for the three-months ended March 31, 2021 mainly due to an increase in consulting expenses. The increase in consulting and contractors\u2019 fees includes variable compensations for an amount of \u20ac253,000 for the three months ended March 31, 2020 and \u20ac498,000 for the three-months ended March 31, 2021 related to a cash-settled share based payment transaction.<\/p>\n

Research and Development Expenses<\/i>. Before capitalization of \u20ac311,000 for the three months ended March 31, 2020, research and development expenses increased by \u20ac0.5 million, or 168%, from \u20ac318,000 (or \u20ac7,000 after capitalization of \u20ac311,000) for the three months ended March 31, 2020 to \u20ac0.9 million for the three months ended March 31, 2021, due to an increase in staff and consulting costs to support the Company\u2019s R&D activities.<\/p>\n

Clinical Expenses.<\/i> Before capitalization of \u20ac1.4 million for the three months ended March 31, 2021 and capitalization of \u20ac568,000 for the three months ended March 31, 2020, clinical expenses increased by \u20ac1.1\u00a0million, or 139%, from \u20ac0.7 million (or \u20ac177,000 after capitalization of \u20ac568,000) for the three months ended March 31, 2020 to \u20ac1.8 million for the three months ended March 31, 2021 (or \u20ac342,000 after capitalization of \u20ac1.4 million). The increase in the expenses was mainly due to an increase in staff and consulting to support the completion of the BETTER SLEEP trial implantations, continuous recruitment for the EliSA trial and the ongoing DREAM IDE trial in the United States.<\/p>\n

Manufacturing Expenses.<\/i> Before capitalization of \u20ac215,000 for the three months ended March 31, 2021 and \u20ac578,000 for the three months ended March 31, 2020, manufacturing expenses increased by \u20ac0.5\u00a0million, or 74%, from \u20ac0.6 million (or \u20ac62,000 after capitalization of \u20ac578,000) for the three months ended March 31, 2020 to \u20ac1.1 million (or \u20ac901,000 after capitalization of \u20ac215,000) for the three months ended March 31, 2021. The increase was mainly due to an increase in staff, in the production and engineering team to support capacity and yield improvement, and in purchasing raw materials to support an increase in production.<\/p>\n

Quality Assurance and Regulatory Expenses.<\/i> Before capitalization of \u20ac133,000 for the three months ended March 31, 2021 and \u20ac263,000 for the three months ended March 31, 2020, quality assurance and regulatory expenses increased by \u20ac170,000, or 59%, from \u20ac288,000 (or \u20ac25,000 after capitalization of \u20ac263,000) for the three months ended March 31, 2020 to \u20ac458,000 (or \u20ac325,000 after capitalization of \u20ac133,000) for the three months ended March 31, 2021. The increase was mainly due to an increase in staff and QA & regulatory activities to support the manufacturing scaling-up process.<\/p>\n

Patent Fees & Related Expenses.<\/i> Before capitalization of \u20ac56,000 for the three months ended March 31, 2020, patent fees & related expenses increased by \u20ac560,000, or 491%, from \u20ac114,000 (or \u20ac58,000 after capitalization of \u20ac56,000) for the three months ended March 31, 2020 to \u20ac0.7 million for the three months ended March 31, 2021 due to expenses related to the in-licensing agreement with Vanderbilt University.<\/p>\n

Therapy Development Expenses.<\/i> Therapy Development expenses increased by \u20ac196,000, or 56%, from \u20ac352,000 for the three months ended March 31, 2020 to \u20ac0.5 million for the three months ended March 31, 2021. The increase in the expenses was mainly due to an increase in staff and consulting to support the launch the commercialization of the Genio\u00ae system in Europe.<\/p>\n

Other Operating Income \/ (Expenses).<\/i> The Company had other operating expenses of \u20ac191,000 for the three months ended March 31, 2020 and operating income of \u20ac4,000 for the three months ended March\u00a031, 2021. The increase in expenses was mainly due to the impact of the initial measurement and re-measurement of the financial debt.<\/p>\n

Operating Loss<\/i><\/p>\n

The increase of operating loss from \u20ac2.1 million for the three months ended March 31, 2020 to \u20ac5.7 million for the three months ended March 31, 2021, or a change of \u20ac3.3 million, was due to increases of activities in all departments. The Company currently conducting three clinical trials to continue gathering clinical data and obtain regulatory approvals. In June 2020, the Company obtained IDE approval to start the DREAM trial in the United States. In line with this strategy, the Company continues to invest in research and development to improve and develop the next generation of the Genio\u00ae system and prepare for scaling-up of production capacities.<\/p>\n

Cash Position<\/b><\/p>\n

Cash and cash equivalents totaled \u20ac86.2 million on March 31, 2021, as compared to \u20ac92.3 million on December 31, 2020.<\/p>\n

Net cash used in operations was \u20ac4.2 million for the three months ended March 31, 2021 compared to \u20ac1.2 million for the three months ended March 31, 2020. The increase of \u20ac3.0 million was primarily due to an increase in a loss for the period of \u20ac3.3 million that was mainly attributable to increased general and administrative expenses, research and development expenses, manufacturing expenses and therapy development expenses, which were offset by a positive variation in the working capital of \u20ac0.5 million.<\/p>\n

Net cash used in investing activities for each of the three months ended March 31, 2021 and the three months ended March 31, 2020 was \u20ac1.8 million.<\/p>\n

Net cash used in financing activities for the three months ended March 31, 2021 was \u20ac104,000 compared to \u20ac24.8 million of net cash provided by financing activities during the three months ended March 31, 2020. The decrease was due to a lack of capital increase during the first quarter of 2021.<\/p>\n

Outlook for 2021<\/b><\/p>\n

The Company\u2019s business, operational, and clinical outlook for 2021 include the following expected milestones and goals:<\/p>\n