Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

Rhea-AI Summary

Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announces preliminary unaudited results for the fourth quarter and full year 2023, with anticipated revenue of approximately €1.8 million for Q4, a 40% increase over Q4 2022, and €4.3 million for the full year 2023, a 41% increase over 2022. The company also ended the year with 48 active German accounts. CEO Olivier Taelman expressed excitement for the strong sales growth, attributing it to the demand for Genio and streamlined patient referral pathways. The company anticipates an exciting 2024 with the upcoming DREAM US pivotal trial data, FDA approval filing, US market entry preparations, and contributions from the ResMed commercial partnership in Germany.

Financial Analyst

The reported preliminary figures from Nyxoah SA indicate a significant uptick in revenue, showcasing a 40% year-over-year increase for Q4 and a 41% increase for the full year. This growth trajectory is noteworthy, particularly the 87% revenue jump from Q3 to Q4, suggesting a robust acceleration in sales momentum. Such performance is often reflective of effective strategic initiatives, in this case, the direct-to-consumer online campaigns and the operational enhancements in patient referral processes.

From an investment standpoint, the strong sales growth and expansion to 48 active German accounts could signal underlying market penetration and product acceptance. These factors are critical when evaluating the company's potential for scalability and long-term revenue generation. Additionally, the anticipation of entering the US market and the upcoming ResMed commercial partnership in Germany may further bolster investor confidence in sustained growth prospects.

However, stakeholders should consider the preliminary nature of these results. The unaudited status means adjustments could occur, which might impact the final figures. Investors should await the audited full financial results for a more accurate assessment of the company's financial health and performance.

Medical Research Analyst

Nyxoah's focus on Obstructive Sleep Apnea (OSA) treatments, particularly the Genio system, addresses a significant market need given the prevalence of OSA globally. The anticipation of data from the DREAM US pivotal trial and subsequent FDA filing are critical milestones that could potentially expand the company's market access and drive future revenue streams.

The market for OSA treatments is competitive and regulatory approval is a key hurdle. The FDA's approval process is stringent and positive trial results could significantly enhance Nyxoah's credibility and market positioning. Moreover, the partnership with ResMed, a leader in the sleep apnea market, could provide valuable commercial leverage in Germany, potentially improving market share and operational efficiency.

Investors should monitor the progression of clinical trials and regulatory outcomes as they can have profound effects on the company's valuation and market potential. The entry into the US market, contingent on FDA approval, represents a substantial opportunity given the size and profitability of the US healthcare sector.

Market Research Analyst

The growth in active accounts, particularly in the German market, indicates effective market penetration strategies by Nyxoah. The direct-to-consumer online campaigns launched in March may have contributed to this increase in engagement, suggesting that the company's marketing strategies are resonating with its target audience.

Entering the US market is a significant strategic move for Nyxoah, as the US represents one of the largest markets for medical devices. The planned FDA approval process will be a pivotal point for the company's expansion strategy. The success of these efforts will be contingent on the company's ability to navigate the regulatory landscape and effectively compete against established players in the OSA space.

Long-term, the company's performance will hinge on its ability to maintain innovation, manage commercial partnerships effectively and scale operations in line with market demand. The ResMed partnership, in particular, could provide a strong distribution channel in Germany, potentially serving as a model for future international expansion.

Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

Mont-Saint-Guibert, Belgium – January 9, 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 announced certain preliminary, unaudited results for the fourth quarter and full year ended December 31, 2023.
  
Preliminary, Unaudited Fourth Quarter and Full Year 2023 Results

• Revenue for the fourth quarter of 2023 is anticipated to be approximately €1.8 million, a 40% increase over the fourth quarter of 2022 and an 87% increase over the third quarter of 2023.
• Revenue for the full year 2023 is anticipated to be approximately €4.3 million, a 41% increase over the full year 2022.
• Ended the year with 48 active German accounts.
  
  

“We are excited with the strong preliminary fourth quarter sales, which are anticipated to be nearly double from last quarter. This anticipated growth reflects both strong underlying demand for Genio and focus on streamlining the patient referral pathway through initiatives such as our direct-to-consumer online campaigns launched in March,” commented Olivier Taelman, Chief Executive Officer. “This performance throughout 2023 sets the stage for an exciting 2024, as in a few months we expect to report data from our DREAM US pivotal trial, file for FDA approval, begin preparations to enter the US market, and begin to see contribution from the ResMed commercial partnership in Germany.”

The preliminary, unaudited revenue results described in this press release are estimates only and are subject to revision until Nyxoah reports its full financial results for 2023 in its Annual Report on Form 20-F.

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 U.S. 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; reporting data from Nyxoah’s DREAM US pivotal trial; filing for FDA approval; entrance to the US market, contributions from the ResMed commercial partnership in Germany; 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 Officer
david.demartino@nyxoah.com
+1 310 310 1313

Attachment

• ENGLISH_Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

What are Nyxoah SA's preliminary unaudited revenue results for Q4 and full year 2023?

Nyxoah SA anticipates revenue of approximately €1.8 million for Q4 2023, a 40% increase over Q4 2022, and €4.3 million for the full year 2023, a 41% increase over 2022.

How many active German accounts did Nyxoah SA end the year with?

Nyxoah SA ended the year with 48 active German accounts.

What initiatives contributed to the strong sales growth in 2023 for Nyxoah SA?

Initiatives such as direct-to-consumer online campaigns launched in March contributed to the strong sales growth in 2023 for Nyxoah SA.

What upcoming developments does Nyxoah SA anticipate in 2024?

In 2024, Nyxoah SA expects to report data from the DREAM US pivotal trial, file for FDA approval, begin preparations to enter the US market, and see contributions from the ResMed commercial partnership in Germany.