REGULATED INFORMATION
Nyxoah Reports First Quarter 2024 Financial and Operating Results
Announced DREAM U.S. pivotal study achieved primary endpoints
On track for FDA approval as early as end of 2024
Mont-Saint-Guibert, Belgium – May 14, 2024 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 first quarter of 2024.
Recent Financial and Operating Highlights
- Reported the DREAM U.S. pivotal study achieved co-primary endpoints on an intent-to-treat (ITT) basis and demonstrated strong AHI reductions in supine and non-supine sleep positions.
- The DREAM study achieved a median AHI reduction of 70.8%, a 12-month AHI responder rate, per the Sher criteria, of 63.5% (p=0.002) on an ITT basis and a 12-month ODI responder rate of 71.3% (p<0.001) on an ITT basis.
- Preparing the fourth and final PMA module for submission this quarter.
- Appointed Dr. Maurits S. Boon, MD as Chief Medical Officer.
- Advanced patient access strategy through partnership with the American Association of Otolaryngology – Head & Neck Surgery Foundation (AAO-HNSF).
- Achieved quarterly sales of €1.2 million, showing 170% growth vs Q1 2023.
- Total cash position of €44.3 million at the end of the quarter.
"The DREAM U.S. study achieving its primary endpoints is a pivotal milestone for Nyxoah and further differentiates Genio as the only HGNS therapy to demonstrate strong efficacy in supine and non-supine OSA. With the DREAM data in hand, our U.S. launch preparations are focused on attracting commercial talent to set us up for success when we introduce Genio," commented Olivier Taelman, Nyxoah Chief Executive Officer. "With continued European commercial traction, positive DREAM data and a highly differentiated, patient centric HGNS solution, I could not be more excited for Nyxoah's future."
First Quarter 2024 Results
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)
For the three months ended March 31, | |||
2024 | 2023 | ||
Revenue | € 1,221 | € 441 | |
Cost of goods sold | (455) | (175) | |
Gross profit | € 766 | € 266 | |
Research and Development Expense | (7,199) | (6,157) | |
Selling, General and Administrative Expense | (5,972) | (5,551) | |
Other income/(expense) | 192 | 46 | |
Operating loss for the period | € (12,213) | € (11,396) | |
Financial income | 1 408 | 625 | |
Financial expense | ( 991) | ( 958) | |
Loss for the period before taxes | € (11,796) | € (11,729) | |
Income taxes | ( 110) | ( 182) | |
Loss for the period | € (11,906) | € (11,911) | |
Loss attributable to equity holders | € (11,906) | € (11,911) | |
Other comprehensive income/(loss) | |||
Items that may not be subsequently reclassified to profit or loss (net of tax) | |||
Currency translation differences | 60 | (28) | |
Total comprehensive loss for the year, net of tax | € (11,846) | € (11,939) | |
Loss attributable to equity holders | € (11,846) | € (11,939) | |
Basic loss per share (in EUR) | € (0.415) | € (0.460) | |
Diluted loss per share (in EUR) | € (0.415) | € (0.460) |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)