Nyxoah (NYXH) Q2 2024 earnings summary

Executive summary

• 2024 is a pivotal year with focus on U.S. market entry, following strong DREAM study results and completion of the modular PMA submission, positioning for potential FDA approval by late 2024 or early 2025.

• Over €85 million in new capital was raised, extending the cash runway into mid-2026 and supporting the buildout of the U.S. commercial organization.

• Strengthened U.S. commercial team with key leadership appointments and ongoing sales force recruitment.

• DREAM U.S. pivotal study data to be presented in September, highlighting Genio's differentiation.

• European sales for H1 2024 reached €2 million, up 29% year-over-year, with 55 active implanting accounts in Germany.

Financial highlights

• Q2 2024 revenue was €780 thousand.

• H1 2024 sales grew 29% year-over-year, despite a Q2 revenue decline.

• Gross margin for Q2 2024 was 63.6%, up from 62.2% in Q2 2023.

• Total operating loss for Q2 was €13.3 million, compared to €11.9 million in Q2 2023, reflecting increased commercial investments.

• Cash and financial assets totaled €78 million as of June 30, 2024, excluding a €10 million EIB loan tranche drawn in July.

Outlook and guidance

• FDA approval for Genio is anticipated by year-end 2024, with a prudent outlook extending to early 2025 due to regulatory uncertainties.

• U.S. commercial launch fully funded with cash runway into mid-2026.

• Revenue in H2 2024 is expected to increase over H2 2023, with continued market growth and impact from new patient referral collaborations.

• Profitability is targeted at approximately $250 million in U.S. sales.

• Full DREAM U.S. pivotal study data to be presented in September 2024.