Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results – Tunisia Information Gazette

REGULATED INFORMATION

Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results
FDA PMA Application Review Nearing Conclusion
Positioned for U.S. Commercial Launch in March 2025

Mont-Saint-Guibert, Belgium – March 13, 2024, 7:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough remedy alternate options for Obstructive Sleep Apnea (OSA) by means of neuromodulation, at present reported monetary and working outcomes for the fourth quarter and monetary yr 2024.

Recent Financial and Operating Highlights

• Revenue for the fourth quarter of 2024 was €1.3 million, which excludes €0.6 million of deferred income
• Revenue for the complete yr 2024 was €4.5 million, which excludes €0.6 million of deferred income
• Gross margin for the fourth quarter of 2024 was 73%
• At December 31, 2024, money and monetary belongings have been €85.6 million, in comparison with €57.7 million at December 31, 2023
• Assembled U.S. govt management staff with deep trade expertise
• Full U.S. business group, together with gross sales, advertising, and market entry groups, in place

“2024 was a transformative year for Nyxoah. We reported best-in-class outcomes from our DREAM pivotal study, completed our PMA submission with the FDA for Genio, and built a world-class U.S. commercial organization,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We believe an approval is still expected by the end of the first quarter, and we look forward to launching this innovative therapy to the millions of Americans suffering from moderate to severe OSA.”

Fourth Quarter and Full Year 2024 Results

Revenue

In the fourth quarter of 2024, the Company started recording a portion of the promoting worth for a Genio system associated to disposable patches as deferred income and acknowledged €0.6 million within the quarter. Due to this deferral, reported income was €1.3 million for the fourth quarter ending December 31, 2024, and €4.5 million for the complete yr. Had the Company not recorded deferred income for its disposable patches, whole income for the fourth quarter would have €1.9 million, up 46% versus the third quarter of 2024. Likewise, income for the complete yr 2024 would have been €5.1 million, up 18% from €4.3 million in 2023. The enhance in full yr income was attributable to the Company’s commercialization of the Genio® system, primarily in Germany.

Cost of Goods Sold

Cost of items bought was €0.3 million for the three months ending December 31, 2024, representing a gross revenue of €0.9 million, or gross margin of 73%. This compares to whole price of products bought of €0.7 million within the fourth quarter of 2023, for a gross revenue of €1.1 million, or gross margin of 60%.

For the complete yr ending December 31, 2024, whole price of products bought was €1.5 million, representing a gross revenue of €3.0 million, or gross margin of 66%. This compares to whole price of products bought of €1.7 million for the complete yr of 2023, for a gross revenue of €2.7 million, or gross margin of 62%.

Research and Development
For the fourth quarter ending December 31, 2024, analysis and improvement bills have been €11.7 million, versus €7.3 million for the fourth quarter ending December 31, 2023. For the complete yr ending December 31, 2024, analysis and improvement bills have been €34.3 million, versus €26.7 million for the complete yr of 2023. The enhance in analysis and improvement bills was primarily pushed by larger R&D actions and scientific bills.

Selling, General and Administrative
For the fourth quarter ending December 31, 2024, promoting, basic and administrative bills have been €8.1million, versus €4.9 million for the fourth quarter ending December 31, 2023. For the complete yr ending December 31, 2024, promoting, basic and administrative bills have been €28.5 million, versus €21.7 million for the complete yr of 2023. The enhance in promoting, basic and administrative bills was primarily attributable to a rise of prices to assist the commercialization of Genio® system in Europe and scale up of the Company.

Operating Loss
Total working loss for the fourth quarter and full yr 2024 was €18.3 million and €58.8 million, respectively, versus €10.8 million and €45.1 million within the fourth quarter and full yr 2023, respectively. This was pushed by the acceleration within the Company’s R&D spending, in addition to ongoing business and scientific actions.

Cash Position
As of December 31, 2024, money and monetary belongings totaled €85.6 million, in comparison with €57.7 million on December 31, 2023.

Annual Report 2024
Nyxoah is at present finalizing the monetary statements for the yr ended December 31, 2024. The Company’s impartial auditor has confirmed that their audit procedures, which have been considerably accomplished, haven’t revealed any materials changes which must be made to the accounting info included on this press launch. The full consolidated monetary statements for the yr ended December 31, 2024 in addition to the full audit report associated to the audit of the consolidated monetary statements might be included in the 2024 Annual Report which the Company goals to publish on or round March 20, 2025. When printed, the Nyxoah Annual Report for the monetary yr 2024 might be accessible on the investor web page of Nyxoah’s web site (https://investors.nyxoah.com/financials).

Conference name and webcast presentation
Company administration will host a convention name to debate monetary outcomes on Thursday, March 13, 2025, starting at 1:00pm CET / 8:00am ET.

A webcast of the decision might be accessible through the Investor Relations web page of the Nyxoah web site or by means of this hyperlink: Nyxoah’s Q4 and FY 2024 Earnings Call Webcast. For these not planning to ask a query of administration, the Company recommends listening through the webcast.

If you plan to ask a query, please use the following hyperlink: Nyxoah’s Q4 and FY 2024 Earnings Call. After registering, an e mail might be despatched, together with dial-in particulars and a novel convention name entry code required to be part of the reside name. To guarantee you are related prior to the starting of the name, the Company suggests registering a minimal of 10 minutes earlier than the beginning of the decision.

The archived webcast will be accessible for replay shortly after the shut of the name.

CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in 1000’s)

About Nyxoah
Nyxoah is reinventing sleep for the billion those that undergo from obstructive sleep apnea (OSA). We are a medical know-how firm that develops breakthrough remedy alternate options for OSA by means of neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation system that’s inserted by means of a single incision beneath the chin and managed by a wearable. Through our dedication to innovation and scientific proof, we’ve got proven best-in-class outcomes for lowering OSA burden.

Following the profitable completion of the BLAST OSA examine, the Genio® system acquired its European CE Mark in 2019. Nyxoah accomplished two profitable IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the optimistic outcomes of the BETTER SLEEP examine, Nyxoah acquired CE mark approval for the growth of its therapeutic indications to Complete Concentric Collapse (CCC) sufferers, at present contraindicated in rivals’ remedy. Additionally, the Company introduced optimistic outcomes from the DREAM IDE pivotal examine for FDA and U.S. commercialization approval.

For extra info, please go to http://www.nyxoah.com/.

Caution – CE marked since 2019. Investigational system within the United States. Limited by U.S. federal regulation to investigational use within the United States.

Forward-looking statements

Certain statements, beliefs and opinions on this press launch are forward-looking, which replicate the Company’s or, as acceptable, the Company administrators’ or managements’ present expectations concerning the Genio® system; deliberate and ongoing scientific research of the Genio® system; the potential benefits of the Genio® system; Nyxoah’s objectives with respect to the event, regulatory pathway and potential use of the Genio® system; the utility of scientific knowledge in doubtlessly acquiring FDA approval of the Genio® system; receipt of FDA approval; entrance to the U.S. market; and the Company’s outcomes of operations, monetary situation, liquidity, efficiency, prospects, progress and methods. By their nature, forward-looking statements contain various dangers, uncertainties, assumptions and different elements that might trigger precise outcomes or occasions to vary materially from these expressed or implied by the forward-looking statements. These dangers, uncertainties, assumptions and elements may adversely have an effect on the end result and monetary results of the plans and occasions described herein. Additionally, these dangers and uncertainties embody, however will not be restricted to, the dangers and uncertainties set forth within the “Risk Factors” part of the Company’s Annual Report on Form 20-F for the yr ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, and subsequent reviews that the Company recordsdata with the SEC. A large number of things together with, however not restricted to, adjustments in demand, competitors and know-how, could cause precise occasions, efficiency or outcomes to vary considerably from any anticipated improvement. Forward wanting statements contained on this press launch concerning previous tendencies or actions will not be ensures of future efficiency and shouldn’t be taken as a illustration that such tendencies or actions will proceed sooner or later. In addition, even when precise outcomes or developments are in line with the forward-looking statements contained on this press launch, these outcomes or developments might not be indicative of outcomes or developments in future intervals. No representations and warranties are made as to the accuracy or equity of such forward-looking statements. As a end result, the Company expressly disclaims any obligation or endeavor to launch any updates or revisions to any forward-looking statements on this press launch on account of any change in expectations or any change in occasions, circumstances, assumptions or circumstances on which these forward-looking statements are based mostly, besides if particularly required to take action by regulation or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such particular person’s officers or workers ensures that the assumptions underlying such forward-looking statements are free from errors nor does both settle for any duty for the longer term accuracy of the forward-looking statements contained on this press launch or the precise prevalence of the forecasted developments. You shouldn’t place undue reliance on forward-looking statements, which converse solely as of the date of this press launch.

Contacts:

Nyxoah
John Landry – CFO
IR@nyxoah.com

For Media
United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com

Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

International/Germany
MC Services – Anne Hennecke
nyxoah@mc-services.eu

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