Company: NYXH
Filing Date: 2025-03-20
Form Type: 20-F
Source: 0001410578-25-000398
Chunk: 3

Company: Nyxoah SA
Filing Date: 2025-03-20
Form: 20-F
Item: Item 5
Chunk 3
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 of December 31, 2024, we had cash and cash equivalents of €34.2 million and financial assets of €51.4 million, long-term debt of €21.3 million and an accumulated deficit of €217.7 million. We have devoted substantially all our resources to research and development activities related to our Genio system, including clinical and regulatory initiatives to obtain marketing approvals and have more recently begun to build our European commercialization infrastructure. During the year ended December 31, 2024, we generated revenue of €4.5 million and our net loss was €59.2 million. We expect that our research and development and selling, general and administrative and other expenses will continue to increase as we expand our marketing efforts to increase sales of the Genio system, conduct clinical trials, seek additional regulatory approvals and clearances and continue to invest in research and development to create product enhancements and enhance our product offering.
Key Factors and Trends
Obtaining regulatory approval in additional significant markets
We must successfully obtain timely approval or clearances and introduce new markets that gain acceptance with physicians. We are currently approved to market in Europe. And for our sales to grow, we will also need to receive FDA marketing authorization for the Genio system. We finalized the enrollment of the DREAM trial, which is our pivotal trial that we intend to rely on to receive marketing authorization in the United States. On March 19, 2024, we issued a press release announcing that the DREAM pivotal trial met its primary endpoints. For more information see “Item 4-Business-Clinical Results and Studies-Pivotal DREAM Trial” above. We applied to the FDA for marketing authorization for the Genio system in the United States with the aim of being commercially available in the United States in the first quarter of 2025. Our ability to expand the list of countries in which we can market and sell our system will significantly impact our revenue growth and the costs we incur in anticipation of such growth. Seeking for and obtaining regulatory approval for the Genio system in any of these countries is a long, expensive and uncertain process that can be impacted by numerous risks which are outside our control.

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Growing and supporting our commercial organization.
We are committed to making additional investments in, and will continue to invest in recruiting, training and retaining experience and specialized sales teams. As of December 31, 2024, our European training, commercial and marketing team consists of eighteen professionals, who have substantial medical device sales and marketing, training and education