The chart below shows how NYXH performed 10 days before and after its earnings report, based on data from the past quarters. Typically, NYXH sees a +1.18% change in stock price 10 days leading up to the earnings, and a -2.55% change 10 days following the report. On the earnings day itself, the stock moves by +0.96%. This data can give you a slight idea of what to expect for the next quarter's release.
Positive
Transformative Year Overview: 2024 was a transformative year for Nyxoah with tremendous progress made throughout the year.
Market Launch Timeline: Genio is expected to be brought to market in the U.S. by the end of March 2025.
AHI and ODI Responder Rates: The DREAM study demonstrated a strong AHI responder rate of 63.5% and an ODI responder rate of 71.3%, with an overall median AHI reduction of 70.8%.
Unique Therapy Efficacy: Genio is the only therapy with clinical evidence proving its efficacy irrespective of a patient’s sleeping position, making it a critical differentiator.
AHI Score Improvement: 82% of all DREAM subjects achieved AHI scores dropping below 15, potentially extending patient lives.
Safety Profile Assessment: Genio demonstrated a favorable safety profile with an 8.7% severe adverse event rate.
Team Development for Market Strategy: The company has built a world-class team in support of the U.S. go-to-market strategy and commercial readiness plan.
Physician Training on Genio Technology: 75 physicians have been trained on the Genio technology and are familiar with its unique features and patient outcomes.
Sequential Revenue Growth: The company recorded a 46% sequential growth in revenue over Q3 2024, with €1.9 million in revenue for Q4 2024, excluding deferred revenue.
Revenue Increase Overview: The full year revenue was €5.1 million, an 18% increase over 2023.
Market Growth Potential: Genio was launched in the U.K. and is covered under the NHS Specialized Service Device program, indicating strong potential for growth in that market.
Milestone Implant Success: The first commercial implant of Genio was successfully performed in the UAE, marking a significant milestone in the Middle East.
Strong Cash Position: The company has a strong cash position of €85.6 million as of December 31, 2024, reflecting disciplined cash management as they prepare for U.S. commercialization.
Negative
Operating Loss Increase: Total operating loss for Q4 2024 was €18.3 million, an increase from €10.8 million in Q4 2023, indicating rising costs and financial strain.
Q4 Revenue Shortfall: Revenue recognized in Q4 2024 was only €1.3 million, significantly lower than expected, and the company recorded deferred revenue of €600,000, which may indicate future revenue uncertainty.
Cash Burn Concerns: Despite a strong cash position of €85.6 million, the increase in cash burn due to accelerated R&D spending and commercial investments raises concerns about sustainability.
FDA Approval Dependency: The company is heavily reliant on FDA approval for its U.S. market entry, and any delays or issues could significantly impact future growth and revenue.
Market Penetration Strategy: The need for a two-pronged strategy to penetrate the U.S. market suggests challenges in gaining immediate acceptance and market share against established competitors.
Nyxoah S.A. (NASDAQ:NYXH) Q4 2024 Earnings Call Transcript
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