Q3 2024 Nyxoah SA Earnings Call Transcript
Key Points
- Nyxoah SA (NYXH) 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.
- 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.
Good day. Thank you for standing by. Welcome to Nyxoah at third quarter, 2024 earnings conference call at this time. All participants are on a listen-only mode. Happy to see the presentation. There will be a question and answer session to ask a question. During the session. You will need to press star 11. You will then hear an automatic advising. Your hand is raised. We know that today's conference is being recorded. I will now hand the conference over to your speaker host Mika Kirkwood Investor Relations and Communications manager. Please go ahead.
Thank you. Good afternoon and good evening, everyone and I welcome you to our earnings call for the third quarter, 2024. I am Mikaela Kirkwood Investor Relations and Communications Manager at Nyxoah.
Participating from the company today will be Olivier Taelman, Chief Executive Officer and Loïc Moreau Chief Financial Officer. During the call, we will discuss our operating activities and review our third quarter financial results
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