Nyxoah Sa’s Earnings Call: Efficacy and Expansion

Nyxoah Sa ((BE:NYXH)) has held its Q4 earnings call. Read on for the main highlights of the call.

Nyxoah Sa’s recent earnings call painted a picture of both promise and challenge. The company celebrated significant strides in clinical efficacy, U.S. market readiness, and international expansion. However, these achievements were tempered by increased operating losses and changes in revenue recognition that have impacted short-term financial performance. Despite these hurdles, Nyxoah’s robust cash position underpins its strategic initiatives, providing a solid foundation for future growth.

Genio’s Efficacy in Treating OSA

The DREAM study results were a highlight, showcasing Genio’s impressive efficacy in treating obstructive sleep apnea (OSA). The study met both primary and secondary endpoints, with a remarkable AHI responder rate of 63.5% and an ODI responder rate of 71.3%. Notably, Genio maintained its effectiveness regardless of the patient’s sleeping position, achieving a 70.8% median AHI reduction.

U.S. Market Launch Preparation

Nyxoah is gearing up for a significant U.S. market entry. A team of 50 commercial members has been trained, and the company has identified CPT code 64568 for reimbursement. With FDA approval anticipated by the end of March 2025, Nyxoah is poised to make a strong impact in the U.S. market.

Expansion in Europe and Beyond

The company has successfully launched Genio in the United Kingdom and the United Arab Emirates, with promising initial results. In Europe, revenue grew by 18% over 2023, reaching €5.1 million for the full year 2024, indicating a positive reception and potential for further growth.

Strong Cash Position

Nyxoah’s financial health remains robust, with a cash position of €85.6 million at the end of 2024, up from €57.7 million at the end of 2023. This increase includes proceeds from a €24.6 million ATM equity raise, providing the company with the financial flexibility to pursue its strategic goals.

Increased Operating Loss

The company reported an operating loss of €18.3 million for Q4 2024, a significant increase from €10.8 million in Q4 2023. This rise is attributed to heightened R&D spending and investments in U.S. commercial operations, reflecting Nyxoah’s commitment to growth and innovation.

Deferred Revenue Impact

Changes in revenue recognition have led to deferred revenue of €600,000 in Q4 2024. The recognized revenue for the quarter was €1.3 million, compared to €1.9 million excluding the impact of deferral, highlighting the short-term financial adjustments the company is navigating.

Forward-Looking Guidance

Nyxoah’s forward-looking guidance underscores its strategic focus on launching the Genio system in the U.S. The company is confident in its clinical outcomes, as evidenced by the DREAM study, and is preparing for FDA approval by March 2025. With a strong cash position and a prepared commercial team, Nyxoah is well-positioned for its U.S. market debut.

In conclusion, Nyxoah Sa’s earnings call reflects a company on the brink of significant expansion, buoyed by strong clinical results and strategic market preparations. While facing financial challenges in the short term, Nyxoah’s robust cash reserves and strategic initiatives position it well for future success. Investors and market watchers will be keenly observing Nyxoah’s next steps as it moves towards its U.S. market launch.