Nyxoah Reports Third Quarter 2023 Financial and Operating Results
Partners with ResMed Germany to increase OSA awareness and therapy penetration
Mont-Saint-Guibert, Belgium – November 8, 2023 10:05pm CET / 4:05pm ET – Nyxoah SA (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 third quarter of 2023.
Recent Financial and Operating Highlights
- Filed the third module in the modular PMA submission.
- Accelerated U.S. pre-commercialization efforts, focused on market access around CPT coding.
- Initiated a commercial partnership with strategic investor ResMed in Germany. This collaboration introduces a novel continuum of care into the German OSA market.
- Reported third-quarter sales of €1.0 million and ended the quarter with 46 active German accounts.
- Ended the quarter with a cash position of €72.5 million, providing an anticipated cash runway into late 2024.
"Nyxoah is entering one of the most exciting times in the company's history. We will report data from our DREAM U.S. pivotal trial early next year, shortly thereafter complete our modular PMA submission, and expect FDA approval late 2024," commented Olivier Taelman, Chief Executive Officer. "Hypoglossal nerve stimulation (HGNS) remains highly underpenetrated and guiding patients through their OSA journey is key to unlocking the market's potential. Our agreement with ResMed Germany, which takes ResMed from a valued investor to commercial partner, creates a continuum of care that directs patients towards the appropriate treatment, resulting in greater therapy penetration."
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)
For the three months ended September 30 | For the nine months ended September 30 | ||||||||
2023 | 2022 | 2023 | 2022 | ||||||
Revenue | € 976 | € 182 | € 2,524 | € 1,777 | |||||
Cost of goods sold | ( 336) | ( 63) | ( 930) | ( 685) | |||||
Gross profit | € 640 | € 119 | € 1,594 | € 1,092 | |||||
Research and Development Expense | (6,568) | (4,221) | (19,330) | (11,286) | |||||
Selling, General and Administrative Expense | (5,058) | (4,763) | (16,794) | (13,492) | |||||
Other income/(expense) | ? | 87 | 265 | 237 | |||||
Operating loss for the period | € (10,986) | € (8,778) | € (34,265) | € (23,449) | |||||
Financial income | 2,178 | 5,127 | 3,592 | 11,372 | |||||
Financial expense | (1,033) | (2,524) | (2 765) | (5,473) | |||||
Loss for the period before taxes | € (9,841) | € (6,175) | € (33,438) | € (17,550) | |||||
Income taxes | 2,229 | (65) | 1,119 | ( 379) | |||||
Loss for the period | € (7,612) | € (6,240) | € (32,319) | € (17,929) | |||||
Loss attributable to equity holders | € (7,612) | € (6,240) | € (32,319) | € (17,929) | |||||
Other comprehensive loss | |||||||||
Items that may be subsequently reclassified to profit or loss (net of tax) | |||||||||
Currency translation differences | ( 10) |