Releases Geral
Nyxoah Reports Third Quarter Financial and Operating Results
AGÊNCIA DE COMUNICAÇÃO Conteúdo de responsabilidade da empresa 6 de novembro de 2024
Nyxoah
REGULATED INFORMATION
Nyxoah Reports Third Quarter Financial and Operating Results
FDA approval on track for first quarter 2025, U.S. commercial team build out in progress
Company fully funded with cash until mid 2026
Mont-Saint-Guibert, Belgium November 6, 2024, 10:05pm CET / 4:05pm ET Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (Nyxoah or the Company), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2024.
Recent Financial and Operating Highlights
- Presented compelling DREAM data results at International Surgical Sleep Society in September.
- Raised 24.6 million through an ATM program from a single U.S. healthcare-dedicated fund providing incremental flexibility as we shift into U.S. commercialization and extending cash runway until mid 2026.
- Strengthened U.S. organization with the hiring of John Landry as Chief Financial Officer and the addition of several key commercial leaders in the U.S.
- Reported third quarter sales of 1.3 million, representing 30% growth versus third quarter 2023.
- Total cash position of 71.0 million at the end of the quarter, 95.6 million proforma including the 24.6 million raised.
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, commented Olivier Taelman, Nyxoahs Chief Executive Officer. I am more confident than ever that we have set Genio up for a strong commercial start in the U.S. immediately after FDA approval.
Third Quarter 2024 Results
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, | |||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 | |
| Revenue | 1,266 |
|
976 |
|
3,258 |
|
2,524 | |
| Cost of goods sold | (482) |
|
(336) |
|
(1,217) |
|
(930) | |
| Gross profit | 784 |
|
640 |
|
2,041 |
|
1,594 | |
| Research and Development Expense | (7,902) |
|
(6,568) |
|
(22,573) |
|
(19,330) | |
| Selling, General and Administrative Expense | (8,042) |
|
(5 058) |
|
(20,396) |
|
(16,794) | |
| Other income/(expense) | 180 |
|
|
430 |
|
265 | ||
| Operating loss for the period | (14,980) |
|
(10,986) |
|
(40,498) |
|
(34,265) | |
| Financial income | 1,138 |
|
2,178 |
|
4,615 |
|
3,592 | |
| Financial expense | (3,043) |
|
(1,033) |
|
(5,480) |
|
(2,765) | |
| Loss for the period before taxes | (16,885) |
|
(9,841) |
|
(41,363) |
|
(33,438) | |
| Income taxes | (173) |
|
2,229 |
|
(724) |
|
1,119 | |
| Loss for the period | (17,058) |
|
(7,612) |
|
(42,087) |
|
(32,319) | |
|
|
|
|
|
|
|
|
|
|
| Loss attributable to equity holders | (17,058) |
|
(7,612) |
|
(42,087) |
|
(32,319) | |
|
|
|
|
|
|
|
|
|
|
| Other comprehensive income/(loss) |
|
|
|
|
|
|
|
|
| Items that may not be subsequently reclassified to profit or loss (net of tax) |
|
|
|
|
|
|
|
|
| Currency translation differences | (209) |
|
(10) |
|
(221) |
|
(88) |
|
| Total comprehensive loss for the year, net of tax | (17,267) |
|
(7,622) |
|
(42,308) |
|
(32,407) | |
| Loss attributable to equity holders | (17,267) |
|
(7,622) |
|
(42,308) |
|
(32,407) | |
|
|
|
|
|
|
|
|
|
|
| Basic loss per share (in EUR) | (0.496) |
|
(0.266) |
|
(1.346) |
|
(1.166) | |
| Diluted loss per share (in EUR) | (0.496) |
|
(0.266) |
|
(1.346) |
|
(1.166) | |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)
|
|
|
|
As at | ||
|
|
|
|
September 30, 2024 |
|
December 31, 2023 |
| ASSETS |
|
|
|
|
|
| Non-current assets |
|
|
|
|
|
| Property, plant and equipment |
|
|
4,461 |
|
4,188 |
| Intangible assets |
|
|
49,558 |
|
46,608 |
| Right of use assets |
|
|
3,635 |
|
3,788 |
| Deferred tax asset |
|
|
53 |
|
56 |
| Other long-term receivables |
|
|
1,475 |
|
1,166 |
|
|
|
|
59,182 |
|
55,806 |
| Current assets |
|
|
|
|
|
| Inventory |
|
|
5,272 |
|
3,315 |
| Trade receivables |
|
|
2,504 |
|
2,758 |
| Other receivables |
|
|
2,992 |
|
3,212 |
| Other current assets |
|
|
1,837 |
|
1,318 |
| Financial assets |
|
|
42,299 |
|
36,138 |
| Cash and cash equivalents |
|
|
28,678 |
|
21,610 |
|
|
|
|
83,582 |
|
68,351 |
| Total assets |
|
|
142,764 |
|
124,157 |
|
|
|
|
|
|
|
| EQUITY AND LIABILITIES |
|
|
|
|
|
| Capital and reserves |
|
|
|
|
|
| Capital |
|
|
5,908 |
|
4,926 |
| Share premium |
|
|
290,906 |
|
246,127 |
| Share based payment reserve |
|
|
8,943 |
|
7,661 |
| Other comprehensive income |
|
|
(84) |
|
137 |
| Retained loss |
|
|
(200,966) |
|
(160,829) |
| Total equity attributable to shareholders |
|
|
104,707 |
|
98,022 |
|
|
|
|
|
|
|
| LIABILITIES |
|
|
|
|
|
| Non-current liabilities |
|
|
|
|
|
| Financial debt |
|
|
19,143 |
|
8,373 |
| Lease liability |
|
|
2,636 |
|
3,116 |
| Pension liability |
|
|
47 |
|
9 |
| Provisions |
|
|
398 |
|
185 |
| Deferred tax liability |
|
|
12 |
|
9 |
|
|
|
|
22,236 |
|
|
