Nyxoah SA (NYXH), a medical technology company focused on developing neuromodulation solutions for obstructive sleep apnea (OSA), announced its third-quarter 2024 financial results, highlighting a 30% increase in revenue compared to the previous year. The company reported revenue of €1.3 million, driven by increased sales of its Genio® system. Nyxoah is preparing for potential FDA approval in Q1 2025 and is actively building its U.S. commercial team.
Financial Performance
Nyxoah's revenue for the third quarter of 2024 reached €1.3 million, a 30% increase compared to the €1.0 million reported in the third quarter of 2023. However, the cost of goods sold also increased to €482,000, resulting in a gross profit of €0.8 million and a gross margin of 62.0%, slightly lower than the 66.0% gross margin in Q3 2023.
Research and development expenses rose to €7.9 million, compared to €6.6 million in the same period last year, reflecting ongoing investments in clinical trials and product development. The total operating loss for the quarter was €15.0 million, compared to €11.0 million in Q3 2023, primarily due to expanded commercial activities and higher R&D investments.
Cash Position and Runway
As of September 30, 2024, Nyxoah's cash and financial assets totaled €71.0 million, compared to €57.7 million on December 31, 2023. The company raised an additional €24.6 million through an ATM program, extending its cash runway to mid-2026. The monthly cash burn during the third quarter of 2024 was approximately €5.6 million.
U.S. Commercialization and FDA Approval
Nyxoah is actively preparing for the U.S. commercial launch of the Genio® system, pending FDA approval, which is anticipated in the first quarter of 2025. The company is building its U.S. commercial team and has strengthened its organization with the hiring of John Landry as Chief Financial Officer and the addition of several key commercial leaders in the U.S.
Olivier Taelman, Nyxoah’s Chief Executive Officer, commented, “Our actions in the third quarter have further positioned us well for a successful U.S. commercial launch. On the back of the robust DREAM data presented in September, we have raised additional capital and are actively focused on building up our U.S. commercial team. I am more confident than ever that we have set ourselves up for a strong commercial start in the U.S. immediately after FDA approval.”
About the Genio® System
The Genio® system is a battery-free hypoglossal neuromodulation device designed to treat obstructive sleep apnea (OSA). It is inserted through a single incision under the chin and controlled by a wearable. The device has received its European CE Mark in 2019 and is currently under investigation in the United States. Nyxoah is seeking FDA approval for U.S. commercialization.
