Nyxoah Reports Fourth Quarter and Financial Year 2023 Financial and Operating Results
Nyxoah reported strong financial results for the fourth quarter and full year 2023, achieving record quarterly sales of €1.8 million. The company filed the third out of four modules in the U.S. modular PMA submission and ended the year with a total cash position of €57.7 million. Nyxoah plans to report DREAM U.S. pivotal study efficacy and safety data by early April and accelerate investments in the U.S. commercial organization for a late 2024 launch.
Positive
Nyxoah achieved record quarterly sales of €1.8 million, representing 87% sequential quarterly growth and 42% year-over-year increase.
The company filed the third out of four modules in the U.S. modular PMA submission and ended 2023 with a total cash position of €57.7 million.
Nyxoah plans to report DREAM U.S. pivotal study efficacy and safety data by early April and accelerate investments in the U.S. commercial organization for a late 2024 launch.
Negative
Research and development expenses increased to €26.7 million for the full year of 2023, compared to €15.9 million in 2022.
Total operating loss for the fourth quarter and full year 2023 was €10.8 million and €45.1 million, respectively, driven by increased R&D spending.
Cash and financial assets decreased to €57.7 million as of December 31, 2023, compared to €94.9 million on December 31, 2022.
The reported financial results of Nyxoah SA for the fourth quarter and financial year 2023 indicate a significant sequential quarterly growth of 87% and a year-over-year revenue increase of 41% . This performance is particularly noteworthy in the context of the medical technology industry, where product adoption rates and market penetration are critical growth indicators. The company's sales figures, primarily driven by the commercialization of the Genio® system in Germany, suggest an effective market strategy and increasing demand for their Obstructive Sleep Apnea (OSA) treatment solutions.
However, the substantial increase in research and development expenses, from €15.9 million in 2022 to €26.7 million in 2023, reflects the company's continued investment in innovation and clinical trials. While this is a positive sign of commitment to product development, it has contributed to an operating loss increase. The cash burn rate of approximately €4.6 million per month is also a critical factor for investors to consider, as it impacts the company's runway and future financing needs. The decrease in cash and financial assets from €94.9 million at the end of 2022 to €57.7 million at the end of 2023 raises questions about long-term financial sustainability and the potential need for additional capital infusions.
The upcoming report on the efficacy and safety data from the DREAM U.S. pivotal study is a pivotal event for Nyxoah. The study's outcome will likely influence the FDA's decision on the Pre-Market Approval (PMA) for the Genio® system. In the medical device sector, such regulatory milestones are critical as they can significantly alter the company's market access and competitive landscape. The Genio® system's approval in the U.S. could open up a substantial market for Nyxoah, considering the prevalence of OSA and the need for innovative treatments.
Furthermore, the initiation of the ACCCESS U.S. pivotal study for complete concentric collapse (CCC) indicates Nyxoah's strategic focus on addressing more complex OSA cases, potentially differentiating their product in a crowded market. The company's R&D investments seem aligned with these strategic priorities, which may justify the increased expenditure in this area despite the current operating losses.
Nyxoah's record quarterly sales and the growth in active German accounts from 38 to 48 suggest successful market penetration strategies in Europe. The targeted direct-to-consumer (DTC) efforts and partnership with ResMed in Germany are likely contributing factors to this growth. In the medical technology market, such partnerships and marketing strategies are essential for product adoption, especially when entering new markets or expanding within existing ones.
The hypoglossal nerve stimulation (HGNS) market is still emerging and Nyxoah's Genio system is part of a niche segment within the broader OSA treatment landscape. The company's ability to increase its market share in Europe and potentially in the U.S. post-regulatory approval, will be critical for its long-term success. Investors should monitor the company's commercialization efforts and market reception of the Genio system closely, as these will be key drivers of future revenue growth.
03/05/2024 - 04:05 PM
Nyxoah Reports Fourth Quarter and Financial Year 2023 Financial and Operating Results Expect to report DREAM U.S. pivotal study efficacy and safety data by early April Achieved record quarterly sales of €1.8 million
Mont-Saint-Guibert, Belgium – March 5, 2024 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 fourth quarter and financial year 2023.
Recent Financial and Operating Highlights
Filed the third out of four modules in the U.S. modular PMA submission. Achieved quarterly sales of €1.8 million , representing sequential quarterly growth of 87% and increasing 42% year-over-year. Achieved 2023 full year sales of €4.3 million , representing 41% year-over-year growth. Ended the year with 48 active German accounts, up from 38 entering 2023. Total cash position of €57.7 million at the end of 2023. 2024 Strategic Priorities
Complete patient follow up in the DREAM U.S. pivotal study and report efficacy and safety data by early April. File the fourth and final module in the modular PMA submission. Accelerate investments in the U.S. commercial organization in preparation for a late 2024 launch. Complete enrollment in the ACCCESS complete concentric collapse (CCC) U.S. pivotal study. Increase hypoglossal nerve stimulation (HGNS) market penetration and Genio market share in Europe. “In 2023, we completed enrollment in our DREAM U.S. pivotal study, presented positive early DREAM efficacy and safety data, initiated enrollment in our ACCCESS U.S. pivotal study for complete concentric collapse and raised capital from both existing and new investors. These accomplishments strengthen our confidence for a transformational 2024.” commented Olivier Taelman, Nyxoah Chief Executive Officer. “We are excited to report DREAM data in the coming weeks, finalize the regulatory FDA submission and pave the way for bringing Genio® to patients in the U.S.”
Mr. Taelman continued, “Commercially in Europe, this quarter’s performance was the strongest in Nyxoah’s history driven by a targeted direct-to-consumer (DTC) effort and I applaud our European commercial team for their execution. I look forward to a further increase in therapy penetration from our partnership with ResMed in Germany.”
Fourth Quarter and Full Year 2023 Results
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS FOR THE THREE MONTHS AND YEARS ENDED DECEMBER 31, 2023 AND DECEMBER 31, 2022 (in thousands)
For the three months ended December 31, For the year ended December 31, 2023 2022 2023 2022 Revenue €1,824 €1,307 €4,348 €3,084 Cost of goods sold (726) (465) (1,656) (1,150) Gross profit €1,098 €842 €2,692 €1,934 Research and Development Expense (7,321) (4,575) (26,651) (15,861) Selling, General and Administrative Expense (4,893) (5,363) (21,687) (18,855) Other income/(expense) 279 46 544 283 Operating loss for the period €(10,837) €(9,050) €(45,102) €(32,499) Financial income 582 (4,609) 4,174 6,763 Financial expense (964) 1,153 (3,729) (4,320) Loss for the period before taxes €(11,219) €(12,506) €(44,657) €(30,056) Income taxes 326 (790) 1,445 (1,169) Loss for the period €(10,893) €(13,296) €(43,212) €(31,225) Loss attributable to equity holders €(10,893) €(13,296) €(43,212) €(31,225) 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 81 70 81 70 Items that may be subsequently reclassified to profit or loss (net of tax) Currency translation differences (32) (82) (120) (96) Total other comprehensive income/(loss) €(39) €(12) €(39) €(26) Total comprehensive loss for the year, net of tax €(10,844) €(13,308) € (43,251) € (31,251) Loss attributable to equity holders €(10,844) €(13,308) € (43,251) € (31,251) Basic loss per share (in EUR) €(379) €(514) €(1,545) €(1,209) Diluted loss per share (in EUR) €(379) €(514) €(1,545) €(1,209)
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS OF DECEMBER 31, 2023 AND DECEMBER 31, 2022 (in thousands)
As at December 31 2023 2022 ASSETS Non-current assets Property, plant and equipment €4,188 €2,460 Intangible assets 46,608 39,972 Right of use assets 3,788 3,159 Deferred tax asset 56 47 Other long-term receivables 1,166 173 €55,806 €45,811 Current assets Inventory 3,315 882 Trade receivables 2,758 1,463 Other receivables 3,212 1,775 Other current assets 1,318 1,284 Financial assets 36,138 76,968 Cash and cash equivalents 21,610 17,888 €68,351 €100,260 Total assets €124,157 €146,071 EQUITY AND LIABILITIES Capital and reserves Capital 4,926 4,440 Share premium 246,127 228,275 Share based payment reserve 7,661 5,645 Other comprehensive income 137 176 Retained loss (160,829) (118,212) Total equity attributable to shareholders €98,022 €120,324 LIABILITIES Non-current liabilities Financial debt 8,373 8,189 Lease liability 3,116 2,586 Pension liability 9 − Provisions 185 59 Deferred tax liability 9 − €11,692 €10,834 Current liabilities Financial debt 364 388 Lease liability 851 719 Trade payables 6,155 4,985 Current tax liability 1,988 3,654 Other payables 5,085 5,167 €14,443 €14,913 Total liabilities €26,135 €25,747 Total equity and liabilities €124,157 €146,071
Revenue
Revenue was €1.8 million for the fourth quarter ending December 31, 2023, compared to €1.3 million for the fourth quarter ending December 31, 2022. Revenue for the full year of 2023 was €4.3 million , compared to €3.1 million for the full year of 2022. The increase in revenue was attributable to the Company’s commercialization of the Genio® system, primarily in Germany.
Cost of Goods Sold
Cost of goods sold was €726,000 for the three months ending December 31, 2023, representing a gross profit of €1.1 million , or gross margin of 60% . This compares to total cost of goods sold of €465,000 in the fourth quarter of 2022, for a gross profit of €842,000 , or gross margin of 64.4% .
For the full year ending December 31, 2023, total cost of goods sold was €1.7 million , representing a gross profit of €2.7 million , or gross margin of 62% . This compares to total cost of goods sold of €1.2 million for the full year of 2022, for a gross profit of €1.9 million , or gross margin of 62.7% .
Research and Development
For the full year ending December 31, 2023, research and development expenses were €26.7 million , versus €15.9 million for the full year of 2022.
Operating Loss
Total operating loss for the fourth quarter and full year 2023 was €10.8 million and €45.1 million , respectively, versus €9.1 million and €32.5 million in the fourth quarter and full year 2022, respectively. This was driven by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities.
Cash Position As of December 31, 2023, cash and financial assets totaled €57.7 million , compared to €94.9 million on December 31, 2022. Total cash burn was approximately €4.6 million per month during 2023.
Full year report 2023 Our independent auditor has not yet completed the audit of the financial statements for the year ended December 31, 2023. When published, the Nyxoah financial report for the full year of 2023 will be available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials ).
Conference call and webcast presentation A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q4 2023 earnings call webcast . For those not planning to ask a question of management, the Company recommends listening via the webcast.
If you plan to ask a question, please use the following link: Nyxoah’s Q4 2023 earnings call . After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start 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, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, 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 David DeMartino, Chief Strategy Officerdavid.demartino@nyxoah.com +1 310 310 1313
What were Nyxoah's quarterly sales for the fourth quarter of 2023?
Nyxoah reported record quarterly sales of €1.8 million for the fourth quarter of 2023.
What was the total cash position of Nyxoah at the end of 2023?
Nyxoah had a total cash position of €57.7 million at the end of 2023.
What is Nyxoah's ticker symbol?
Nyxoah's ticker symbol is NYXH.
What are Nyxoah's 2024 strategic priorities?
Nyxoah's 2024 strategic priorities include completing patient follow up in the DREAM U.S. pivotal study, filing the final module in the modular PMA submission, accelerating investments in the U.S. commercial organization, completing enrollment in the ACCCESS U.S. pivotal study, and increasing market penetration and market share in Europe.
Where can investors find Nyxoah's full year 2023 financial report?
Investors can find Nyxoah's full year 2023 financial report on the investor page of Nyxoah's website at https://investors.nyxoah.com/financials.