Release Date: November 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 efficacy endpoints in its Dream pivotal study, demonstrating strong safety and potential best-in-class outcomes for obstructive sleep apnea patients.
- The company has strengthened its balance sheet with EUR24.6 million in new capital raised from a US healthcare fund, extending its cash runway to mid-2026.
- Nyxoah SA (NYXH) is actively building its US commercial organization, including hiring key executive roles and preparing for a commercial launch.
- The Dream study showed a significant reduction in apnea and hypopnea events, with a 70.8% reduction in supine position, highlighting Genio's unique efficacy.
- The company has secured a loan facility agreement with the European Investment Bank for EUR37.5 million, providing additional financial flexibility.
Negative Points
- Nyxoah SA (NYXH) reported an operating loss of EUR15 million for the third quarter, an increase from EUR11 million in the same quarter of 2023, due to accelerated commercial investments.
- FDA approval for Genio is now anticipated in the first quarter of 2025, delayed from the initial expectation of year-end 2024 due to rescheduled site inspections.
- The company faces challenges in securing reimbursement, although it is working on a comprehensive strategy and engaging with major payers.
- There is uncertainty regarding the publication timeline of the Dream study in a leading medical journal, which is crucial for broader acceptance.
- Nyxoah SA (NYXH) is experiencing increased cash burn, with a monthly rate of EUR5.6 million, as it ramps up its US commercialization efforts.
Q & A Highlights
Q: What has been the feedback from the clinician community on the dream data, particularly regarding supine versus non-supine positions?
A: Olivier Taelman, CEO, explained that the clinician community reacted positively to the dream study's unique requirement for patients to sleep at least 60 minutes in a supine position. The study showed comparable efficacy in reducing AHI regardless of sleeping position, which resonated well with physicians. The modified intention-to-treat (ITT) data, showing a 66% response rate, is considered most relevant for physicians.
Q: Can you provide more details on the CPT code strategy for reimbursement and the confidence in onboarding US payers quickly after launch?
A: Olivier Taelman, CEO, stated that Nyxoah is executing a comprehensive reimbursement strategy, using an established CPT code recognized by payers for OSA at launch. They are also pursuing a Genio-specific CPT code over time, working closely with the American Academy of Otology and participating in the FDA's early payer feedback program to educate CMS and major commercial payers.
Q: What is the status of the FDA approval timeline for Genio, and what caused the shift from a year-end 2024 expectation to Q1 2025?
A: Olivier Taelman, CEO, clarified that the FDA approval timeline shifted due to a delay in the Belgium site inspection, which was rescheduled by the FDA. Despite this, Nyxoah remains confident in receiving approval in Q1 2025, following significant progress in site visits and audits.
Q: How does Nyxoah plan to differentiate its marketing strategy from competitors like Inspire, and what are the low-hanging fruits in the US market?
A: Olivier Taelman, CEO, outlined a two-pronged approach focusing on tier-one hypoglossal nerve stimulation implanting accounts and driving referrals from sleep physicians managing high numbers of moderate to severe OSA patients. The strategy includes a commercial organization of about 50 people, supported by focused DTC investments and a dedicated team for preauthorization efforts.
Q: How is Nyxoah preparing to meet demand from a supply standpoint for the US launch?
A: Olivier Taelman, CEO, mentioned that Nyxoah has made significant progress with manufacturing capabilities, having a site in Belgium and a contract manufacturer in the US. Both sites are prepared to meet demand, with the US site having passed FDA inspection without deficiencies, ensuring readiness for the US and European markets.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
