Nyxoah (NYXH) Q3 2024 earnings summary

Executive summary

• DREAM U.S. pivotal study for Genio met all efficacy and safety endpoints, with a 12-month AHI responder rate of 63.5% and ODI responder rate of 71.3%, supporting FDA submission and U.S. market entry.

• European commercialization expanded, with €3.3 million revenue in nine months, mainly from Germany, and new market entries in Switzerland, Austria, Spain, and Italy.

• Strengthened U.S. leadership team and commercial infrastructure, including key executive hires and CEO relocation.

• Extended cash runway to mid-2026 following a €24.6 million capital raise, €37.5 million EIB loan facility, and $27 million ATM offering.

• Strategic focus on building Centers of Excellence and securing reimbursement in key European markets.

Financial highlights

• Revenue for nine months ended September 30, 2024 was €3.3 million, up from €2.5 million year-over-year; Q3 2024 revenue was €1.3 million.

• Net loss widened to €42.1 million from €32.3 million for the same period last year; Q3 2024 operating loss was €15 million, up from €11 million in Q3 2023.

• Cash and financial assets totaled €71 million as of September 30, 2024, up from €57.7 million at December 31, 2023.

• Monthly cash burn in Q3 was €5.6 million; cash burn from operating activities was €37 million for the nine months.

• Selling, general and administrative expenses rose 21% to €20.4 million, driven by commercialization and ERP costs.

Outlook and guidance

• FDA approval for Genio expected in Q1 2025, with U.S. commercial launch preparations underway.

• Commercial organization to reach approximately 50 people at launch, focusing on tier one implanting accounts and high-referral sleep physicians.

• Anticipates continued increase in OpEx through Q1/Q2 2025, then flattening and decreasing as U.S. sales ramp up.

• Anticipates continued sales ramp-up in Germany and other European markets.

• Ongoing enrollment in ACCCESS study for US CCC patient approval.