Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Nyxoah SA (NYXH, Financial) achieved primary endpoints in the DREAM US pivotal study, demonstrating strong efficacy for the Genio system in treating OSA patients.
- The company raised over EUR85 million in new capital, extending its cash runway into mid-2026.
- European sales increased by 29% in the first half of 2024 compared to the first half of 2023, with 55 active implanting accounts in Germany.
- Nyxoah SA (NYXH) is actively preparing for US market entry, with FDA approval anticipated by late 2024 or early 2025.
- The company is building a US commercialization organization, including the hiring of a new Chief Commercial Officer and other key leadership roles.
Negative Points
- Total operating loss for the second quarter was EUR13.3 million, an increase from EUR11.9 million in the second quarter of 2023.
- The German market, while showing growth, remains small and subject to quarter-to-quarter variability.
- There were 11 serious adverse events in the DREAM study, with 3 being device-related and resulting in explants.
- Revenue for the second quarter was EUR780,000, which was below some analysts' expectations.
- The company anticipates an increase in cash burn starting in Q3 2024 due to ramp-up efforts for the US launch.
Q & A Highlights
Q: What lessons has Nyxoah learned from its operations in Germany, and how are these applicable to the US market?
A: Olivier Taelman, CEO, explained that Nyxoah's goals in Germany were to break the monopoly in hypoglossal nerve stimulation and expand the market. They achieved a 27% market share in Germany within two years, exceeding expectations. The experience in Germany, where they have a significant market share in top accounts, provides confidence for the US launch. However, Germany remains a small revenue market with potential quarter-to-quarter variability.
Q: Can you provide an update on the ACCESS trial and the commercial launch strategy for the US?
A: Olivier Taelman stated that the ACCESS trial is progressing, with plans to close implants by the end of 2024. For the US launch, Nyxoah will focus on high-volume Tier 1 accounts, initially targeting 150 out of 200-250 accounts. They will start with 15 territory managers and scale up gradually, supported by field engineers and sleep specialists.
Q: What is Nyxoah's US reimbursement strategy?
A: Olivier Taelman mentioned that Nyxoah is partnering with the American Association of Otolaryngology to establish a bridge Category 1 CPT code for launch. They are also pursuing a geo-specific CPT code, which may take longer. At launch, existing Medicare claims will use the bridge code, with reimbursements aligned with current AG&S payment rates. Nyxoah is engaging with payers to leverage existing coverage policies.
Q: How is Nyxoah preparing for the manufacturing ramp ahead of the US launch?
A: Olivier Taelman confirmed that Nyxoah is prepared to meet demand with their Genio 2.1 version currently used in Europe. They plan to launch in the US with the Genio 3.1 version, which includes improvements for better patient feedback and gross margins. Manufacturing lines are set up in both the US and Europe to ensure capacity and risk mitigation.
Q: How does Nyxoah view the impact of GLP-1s on their business, particularly in light of the SURMOUNT-OSA study?
A: Olivier Taelman welcomed GLP-1s, noting they could increase the OSA patient market. The SURMOUNT-OSA study showed a reduction in AHI and BMI, but the magnitude of OSA reduction was below that of hypoglossal nerve stimulation. Lowering BMI enhances the therapeutic effect of hypoglossal nerve stimulation, suggesting GLP-1s could expand the patient funnel for Nyxoah's technology.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
