Nyxoah Reports First Quarter 2023 Financial and Operating Results
REGULATED INFORMATION
Nyxoah Reports First Quarter 2023 Financial and Operating Results
Mont-Saint-Guibert, Belgium May 16, 2023 10:05pm CET / 4:05pm ET Nyxoah SA (Euronext Brussels/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 2023.
Recent Financial and Operating Highlights
- Completed all 115 implants in the DREAM U.S. pivotal trial, with 12-month data expected in the first quarter of 2024.
- Initiated the modular PMA submission with the filing of the first module.
- Submitted 12-month data1 on the first 34 DREAM patients as a late-breaking abstract to SLEEP 2023 demonstrating a 65% AHI responder rate, a 76% ODI responder rate and safety in-line with expectations. The abstract will be presented in a late-breaking poster session on June 6th. These data are preliminary and not conclusive of final DREAM success.
- Implanted the first patients in the ACCCESS U.S. IDE pivotal study to treat complete concentric collapse (CCC). Implant completion expected in 2024.
- Hired Christoph Eigenmann as Chief Commercial Officer.
- Raised 19 million from new and historical shareholders including ResMed, Cochlear and Robert Taub, Nyxoahs Chairman and Founder.
- Ended the quarter with 40 active German accounts and quarterly sales of 441 thousand.
- Expanded European market access with first implants in Austria.
- Strengthened the supply chain with the Belgium manufacturing facility receiving clearance from the EU notified body.
In 2023, our focus is in the U.S. on DREAM patient follow up resulting in reaching the primary endpoints. I am excited by the data on the first 34 patients and look forward to sharing the full abstract results at SLEEP 2023 next month. Our increasing conviction in DREAM outcomes is accelerating investment in our commercial organization, starting with the addition of Christoph as Chief Commercial Officer, commented Olivier Taelman, Nyxoahs Chief Executive Officer. Christophs hire, along with the 19 million raised from key investors, puts us in a strong position as we embark on our next stage of growth.
First Quarter 2023 Results
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2023 (in thousands)
| For the three months ended March 31 | |||||||||||
| 2023 | 2022 | ||||||||||
| Revenue | 441 | 660 | |||||||||
| Cost of goods sold | (175) | (289) | |||||||||
| Gross profit | 266 | 371 | |||||||||
| Research and Development Expense | (6,157) | (3,595) | |||||||||
| Selling, General and Administrative Expense | (5,551) | (4,193) | |||||||||
| Other income/(expense) | 46 | 136 | |||||||||
| Operating loss for the period | (11,396) | (7,281) | |||||||||
| Financial income | 625 | 1,576 | |||||||||
| Financial expense | (958) | (788) | |||||||||
| Loss for the period before taxes | (11,729) | (6,493) | |||||||||
| Income taxes | (182) | (208) | |||||||||
| Loss for the period | (11,911) | (6,701) | |||||||||
| Loss attributable to equity holders | (11,911) | (6,701) | |||||||||
| Other comprehensive loss | |||||||||||
| Items that may be subsequently reclassified to profit or loss (net of tax) | |||||||||||
| Currency translation differences | (28) | ( 102) | |||||||||
| Total comprehensive loss for the year, net of tax | (11,939) | (6,803) | |||||||||
| Loss attributable to equity holders | (11,939) | (6,803) | |||||||||
| Basic Loss Per Share (in EUR) | (0.460) | (0.260) | |||||||||
| Diluted Loss Per Share (in EUR) | (0.460) | (0.260) | |||||||||
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS OF MARCH 31, 2023 (in thousands)
| | |||||||||
| As at | |||||||||
| March 31 2023 | December 31 2022 | ||||||||
| ASSETS | |||||||||
| Non-current assets | |||||||||
| Property, plant and equipment | 2,721 | 2,460 | |||||||
| Intangible assets | 42,447 | 39,972 | |||||||
| Right of use assets | 3,669 | 3,159 | |||||||
| Deferred tax asset | 50 | 47 | |||||||
| Other long-term receivables | 169 | 173 | |||||||
| 49,056 | 45,811 | ||||||||
| Current assets | |||||||||
| Inventory | 1,249 | 882 | |||||||
| Trade receivables | 1,499 | 1,463 | |||||||
| Other receivables | 1,419 | 1,775 | |||||||
| Other current assets | 1,663 | 1,284 | |||||||
| Financial assets | 62,403 | 76,968 | |||||||
| Cash and cash equivalents | 33,664 | 17,888 | |||||||
| 101,897 | 100,260 | ||||||||
| Total assets | 150,953 | 146,071 | |||||||
| EQUITY AND LIABILITIES | |||||||||
| Capital and reserves | |||||||||
| Capital | 4,859 | 4,440 | |||||||
| Share premium | 243,488 | 228,275 | |||||||
| Share based payment reserve | 6,582 | 5,645 | |||||||
| Other comprehensive income | 148 | 176 | |||||||
| Retained loss | (130,051) | (118,212) | |||||||
| Total equity attributable to shareholders | 125,026 | 120,324 | |||||||
| LIABILITIES | |||||||||
| Non-current liabilities | |||||||||
| Financial debt | 8,381 | 8,189 | |||||||
| Lease liability | 3,112 | 2,586 | |||||||
| Pension liability | 25 | ||||||||
| Provisions | 74 | 59 | |||||||
| Deferred tax liability | |||||||||
| 11,592 | 10,834 | ||||||||
| Current liabilities | |||||||||
| Financial debt | 390 | 388 | |||||||
| Lease liability | 711 | 719 | |||||||
| Trade payables | 5,012 | 4,985 | |||||||
| Current tax liability | 3,619 | 3,654 | |||||||
| Other payables | 4,603 | 5,167 | |||||||
| 14,335 | 14,913 | ||||||||
| Total liabilities | 25,927 | 25,747 | |||||||
| Total equity and liabilities | 150,953 | 146,071 | |||||||
Revenue
Revenue was 441,000 for the first quarter ending March 31, 2023, compared to 660,000 for first quarter ending March 31, 2022.
Cost of Goods Sold
Cost of goods sold was 175,000 for the three months ending March 31, 2023, representing a gross profit of 266,000, or gross margin of 60.3%. This compares to total cost of goods sold of 289,000 in the first quarter ending March 31, 2022, for a gross profit of 371,000, or gross margin of 56.2%.
Research and Development Expenses
Research and development expenses were 6.2 million for the three months ending March 31, 2023, versus 3.6 million for the prior year period, driven by an acceleration in clinical activities, notable the start of the ACCCESS study.
Selling, General and Administrative Expenses
Selling, general and administrative expenses rose to 5.6 million for the first quarter of 2023, up from 4.2 million in the first quarter of 2022. This was due primarily to increased commercial efforts in Germany and other European markets, as well as investments in Nyxoahs corporate infrastructure. The Company expects to continue adding headcount across the organization ahead of the U.S. commercial launch.
Operating Loss
Total operating loss for the first quarter 2023 was 11.4 million versus 7.3 million in the first quarter of 2022. This was driven by the acceleration in the Companys R&D spending, as well as ongoing commercial and clinical activities.
Cash Position
As of March 31, 2023, cash and financial assets totaled 96.1 million, compared to 94.9 million on December 31, 2022. Total cash burn was approximately 4.9 million per month during the first quarter of 2023.
First Quarter 2023 Report
Nyxoahs financial report for the first quarter of 2023, including details of the consolidated results, are available on the investor page of Nyxoahs website (https://investors.nyxoah.com/financials).
Conference call and webcast presentation
Nyxoah will conduct a conference call open to the public today at 10:30pm CET / 4:30pm ET, which will also be webcast. To participate in the conference call, please access the following link to register for a dial-in number: https://edge.media-server.com/mmc/p/imeku8f7
A question-and-answer session will follow the presentation of the results. To access the live webcast, go to https://investors.nyxoah.com/events. The archived webcast will be available for replay shortly after the close of the call.
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoahs lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the worlds most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.
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