Nyxoah (NYXH) Q3 2024 earnings summary

Executive summary

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

• Filed the final module of the modular PMA submission in June; FDA approval now anticipated in Q1 2025 due to a delayed Belgian site inspection.

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

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

• Raised €24.6 million in new capital and secured a €37.5 million loan facility, extending cash runway to mid-2026.

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.

• Cash and financial assets totaled €71 million as of September 30, 2024, excluding the €24.6 million capital raise in October.

• Monthly cash burn during Q3 was €5.6 million.

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.

• Cash runway projected through mid-2026, with OpEx expected to rise in Q4 2024 and flatten by mid-2025 as sales ramp up.

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

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