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 +2.87% change in stock price 10 days leading up to the earnings, and a -0.84% change 10 days following the report. On the earnings day itself, the stock moves by -0.25%. This data can give you a slight idea of what to expect for the next quarter's release.
Positive
DREAM Study Efficacy Results: 1. Strong DREAM Study Results: The DREAM study achieved an apnea hypopnea index (AHI) responder rate of 63.5% on an intent-to-treat basis and 66.4% on a modified intent-to-treat basis, with a p-value of 0.002, demonstrating significant efficacy for the Genio system.
Supine Position Efficacy: 2. High Efficacy in Supine Position: The study showed a median 12-month AHI reduction of 70.8% for patients sleeping on their back, indicating Genio's effectiveness regardless of sleeping position, which is a unique advantage in the market.
Favorable Safety Profile: 3. Robust Safety Profile: The DREAM study reported a serious adverse event (SAE) ratio of 8.7%, with only three device-related SAEs, showcasing a favorable safety profile compared to existing therapies.
Capital Raise for Expansion: 4. Significant Capital Raise: Nyxoah raised €24.6 million in October from a U.S. healthcare dedicated fund, enhancing its financial flexibility as it prepares for U.S. commercialization and extending its cash runway until mid-2026.
U.S. Leadership Expansion: 5. Expansion of U.S. Presence: The company has strengthened its U.S. leadership team with key hires, including a Chief Medical Officer and Chief Commercial Officer, to support the upcoming launch of Genio, indicating a proactive approach to market entry.
Negative
Operating Loss Increase: 1. Increased Operating Loss: The total operating loss for Q3 2024 was €15 million, up from €11 million in Q3 2023, indicating a significant increase in losses due to accelerated commercial investments in the U.S.
Revenue Challenges Ahead: 2. Low Revenue Generation: Revenue for Q3 2024 was only €1.3 million, reflecting challenges in generating substantial income as the company prepares for U.S. commercialization.
Cash Burn Concerns: 3. High Cash Burn Rate: The monthly cash burn rate was €5.6 million during the quarter, raising concerns about the sustainability of operations without significant revenue inflow.
FDA Approval Delay: 4. Delayed FDA Approval Timeline: The anticipated FDA approval for Genio has shifted from December 2024 to Q1 2025 due to delays in the Belgium site inspection, indicating potential setbacks in commercialization plans.
Rising Operational Costs: 5. Increased Operational Expenses: The company expects a continued increase in operational expenses in Q4 2024 as they ramp up hiring and prepare for the U.S. launch, which could strain financial resources further.
Nyxoah S.A. (NYXH) Q3 2024 Earnings Call Transcript
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