Nyxoah Reports Full Year 2021 Operating and Financial Results
Nyxoah reported significant growth in its full-year 2021 results, generating revenue of €852,000 from the Genio® system commercialization, up from €69,000 in 2020, achieving a gross margin of 64.4%. The company made strides in Germany with a DRG code and secured reimbursement in Spain, while expanding its addressable market by 30% after receiving expanded CE mark approval. Despite a net loss of €27.6 million, up from €12.2 million in 2020, Nyxoah's cash position improved to €135.5 million after a successful IPO, positioning the company for continued operational momentum in 2022.
- Revenue increased to €852,000 in 2021 from €69,000 in 2020, a significant growth.
- Achieved a gross margin of 64.4%, up from 56.5% in 2020.
- Expanded market reach by 30% with new CE mark indications for treating CCC patients.
- Raised €97.8 million in July 2021 IPO, enhancing liquidity.
- Net loss increased to €27.6 million in 2021 from €12.2 million in 2020.
- General and administrative expenses rose to €11.1 million, significantly impacting profitability.
REGULATED INFORMATION
Nyxoah Reports Full Year 2021 Operating and Financial Results
Mont-Saint-Guibert, Belgium – March 24, 2022, 9:30pm CET / 4:30pm 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 full year ending December 31, 2021.
Full Year 2021 Operational and Financial Highlights
- Generated revenue of
€852,000 from the commercialization of Genio® in Europe, mainly in Germany; gross margin was64.4% - Achieved strong commercial progress in Germany after obtaining a DRG code for the Genio system
- Obtained DRG coding in Switzerland and hospital reimbursement in Spain; awaiting reimbursement decisions in other key European markets
- Reported positive data from the BETTER SLEEP clinical trial, which achieved its primary safety and performance endpoints, with statistically significant reduction in baseline AHI scores for the overall study and the complete concentric collapse (CCC) and non-CCC patient cohorts; per the Sher criteria, after 6 months, achieved responder rates of
64% for the entire population (CCC and non-CCC),60% for the CCC cohort, and67% for the non-CCC cohort - Received expanded CE mark indication to treat CCC patients, thus increasing the total addressable market by at least
30% and enabling patients not to have to undergo a Drug-Induced Sleep Endoscopy (DISE) procedure prior to implantation - Granted U.S. FDA Breakthrough Device Designation for the treatment of adult patients with moderate-to-severe OSA and CCC; awaiting IDE approval to commence a trial for CCC patients in the U.S. in late 2022
- Advanced patient enrollment in the DREAM U.S. IDE study, with implants expected to be completed in the second quarter of 2022
- Raised
$97.8 million in a Nasdaq initial public offering in July, successfully completing Nyxoah’s second IPO after previously raising€84.8 million in the September 2020 Euronext Brussels IPO - Entered exclusive licensing agreement with Vanderbilt University (US) to develop next generation neurostimulation technologies, specifically a novel stimulator focused on the Ansa Cervicalis nerve, which could further expand the eligible to treat OSA patient population.
“2021 was a very strong year for Nyxoah. I am proud of the team maintaining their focus on execution while operating in a challenging market environment. We reached numerous milestones in 2021 and feel we are well positioned to further build on this momentum in 2022,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Through the BETTER SLEEP study results, we are now able to offer an effective solution for CCC patients with an expanded CE mark indication in Europe, and we are working hard to initiate a CCC-focused IDE trial in the US. Particularly encouraging are the strong responder rates in all patient cohorts, further increasing our confidence in positive outcomes from the ongoing DREAM study.”
“We have also been happy with our commercial progress in Europe, focusing on Germany, where we obtained a dedicated DRG code.” continued Mr. Taelman. “We already had 12 active implant sites in December 2021 and continue to expand rapidly. In addition, we have secured a DRG code in Switzerland and hospital reimbursement in Spain while we await final reimbursement decisions in the Netherlands and Belgium. Our commercial strategy is based on a deep understanding of the patient journey, building strong relationships with implanting surgeons and further strengthening their relationships with referring sleep physicians, in combination with digital marketing programs.”
Mr. Taelman continued, “We secured CE mark MR conditional labeling for Genio®, enabling all implanted patients to safely undergo 1.5T and 3T MRI diagnostics scans. Genio® is now the only HGNS device with an MRI compatibility label for full-body and 3T. This illustrates our patient-centric strategy, and you can soon expect to hear more on the progress made by our R&D team. Short term, we expect to launch the next generation Genio® 2.1, which includes a patient-centric smartphone app and will incorporate a position sensor to adjust stimulation levels based on sleeping position. Looking further into the future, we are proud of our collaboration with Vanderbilt University and Dr. Kent that should result in novel treatment options for OSA patients, starting with Ansa Cervicalis stimulation.”
“With our second successful IPO in the span of 10 months last July, we have a strong balance sheet that provides ample liquidity to complete the DREAM study, conduct our U.S. CCC IDE study, invest in pre-commercial activities in the U.S., and remain committed to our important R&D priorities. We are extremely excited about where we are today as a company, and we look forward to providing further updates as the year progresses,” concluded Mr. Taelman.
Full Year 2021 Results
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (in thousands)
| For the year ended December 31 | ||||||
| 2021 | 2020 | |||||
| Revenue | € 852 | € 69 | ||||
| Cost of goods sold | (303) | (30) | ||||
| Gross profit | € 549 | € 39 | ||||
| General and administrative expenses | (11 113) | (7 522) | ||||
| Research and development expenses | (2 353) | (473) | ||||
| Clinical expenses | (2 706) | (1 053) | ||||
| Manufacturing expenses | (4 760) | (460) | ||||
| Quality assurance and regulatory expenses | (1 463) | (227) | ||||
| Patents fees & Related | (1 062) | (123) | ||||
| Therapy development expenses | (3 599) | (1 864) | ||||
| Other operating income / (expenses) | 265 | 459 | ||||
| Operating loss for the period | | | ||||
| Financial income | 3 675 | 62 | ||||
| Financial expense | (2 072) | (990) | ||||
| Loss for the period before taxes | | | ||||
| Income taxes | (2 980) | (93) | ||||
| Loss for the period | | | ||||
| Loss attributable to equity holders | | | ||||
| Other comprehensive income/(loss) | ||||||
| Items that may not be subsequently reclassified to profit or loss (net of tax) | ||||||
| Remeasurements of post-employment benefit obligations, net of tax | (68) | − | ||||
| Items that may be subsequently reclassified to profit or loss (net of tax) | ||||||
| Currency translation differences | 121 | (58) | ||||
| Total other comprehensive income/(loss) | € 53 | | ||||
| Total comprehensive loss for the year, net of tax | | | ||||
| Loss attributable to equity holders | | | ||||
| Basic loss per share (in EUR) | | | ||||
| Diluted loss per share (in EUR) | | | ||||
CONSOLIDATED BALANCE SHEETS (in thousands)
| As at December 31 | ||||||
| 2021 | 2020 | |||||
| ASSETS | ||||||
| Non-current assets | ||||||
| Property, plant and equipment | | € 713 | ||||
| Intangible assets | 25 322 | 15 853 | ||||
| Right of use assets | 3 218 | 3 283 | ||||
| Deferred tax asset | 46 | 32 | ||||
| Other long-term receivables | 164 | 91 | ||||
| | | |||||
| Current assets | ||||||
| Inventory | 346 | 55 | ||||
| Trade receivables | 226 | − | ||||
| Other receivables | 2 286 | 1 644 | ||||
| Other current assets | 1 693 | 109 | ||||
| Cash and cash equivalents | 135 509 | 92 300 | ||||
| | | |||||
| Total assets | | | ||||
| EQUITY AND LIABILITIES | ||||||
| Capital and reserves | ||||||
| Capital | 4 427 | 3 796 | ||||
| Share premium | 228 033 | 150 936 | ||||
| Share based payment reserve | 3 127 | 2 650 | ||||
| Other comprehensive income | 202 | 149 | ||||
| Retained loss | (87 167) | (60 341) | ||||
| Total equity attributable to shareholders | | | ||||
| LIABILITIES | ||||||
| Non-current liabilities | ||||||
| Financial debt | 7 802 | 7 607 | ||||
| Lease liability | 2 737 | 2 844 | ||||
| Pension liability | 80 | 37 | ||||
| Provisions | 12 | − | ||||
| Deferred tax liability | 5 | − | ||||
| | | |||||
| Current liabilities | ||||||
| Financial debt | 554 | 616 | ||||
| Lease liability | 582 | 473 | ||||
| Trade payables | 3 995 | 1 190 | ||||
| Current tax liability | 2 808 | − | ||||
| Other payables | 3 633 | 4 123 | ||||
| | | |||||
| Total liabilities | | | ||||
| Total equity and liabilities | | | ||||
Revenue
Revenue was
Cost of Goods Sold
Cost of goods sold was
General and Administrative Expenses
General and administrative expenses rose to
Research and Development Expenses
Research and Development expenses were
Clinical Expenses
Clinical expenses increased to
Manufacturing Expenses
Manufacturing expenses increased to
Quality Assurance and Regulatory Expenses
Quality assurance and regulatory expenses of
Patent Fees & Related Expenses
Patents fees and related expenses increased from
Therapy Development Expenses
Therapy development expenses were
Operating Loss
The Company realized a net loss of
Cash Position
Cash and cash equivalents totaled
Net cash used in operations was
Net cash used in investing activities was
Net cash generated in financing activities for the twelve months ending December 31, 2021, was
Outlook for 2022
The Company’s business, operational, and clinical outlook for 2022 include the following expected milestones and goals:
- Completing DREAM trial implants in the second quarter of 2022
- Continuing commercial execution in Germany
- Commencing a U.S. IDE study for CCC patients in the fourth quarter of 2022
Full-year report 2021
Nyxoah’s financial report for the full year 2021, including details of the audited consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).
Conference call and webcast presentation
Nyxoah will conduct a conference call to open to the public tomorrow, March 25, 2022, at 1:00 p.m. CET / 8:00 a.m. ET, which will also be webcasted. To participate in the conference call, please dial one of the following numbers:
Conference ID: 3688760
USA: (844) 260-3718
Belgium: 0800 73264
International: (929) 517-0938
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). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s 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.
For more information, please visit http://www.nyxoah.com/.
Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.
Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2021, to be filed with the Securities and Exchange Commission (“SEC”) on March 24, 2022, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
Contacts:
Nyxoah
Loic Moreau, Chief Financial Officer
corporate@nyxoah.com
+32 473 33 19 80
Jeremy Feffer, VP IR and Corporate Communications
jeremy.feffer@nyxoah.com
+1 917 749 1494
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