Nyxoah (NYXH) Q4 2024 earnings summary

Executive summary

• 2024 marked a transformative year, highlighted by strong clinical results for Genio and preparations for a U.S. market launch by March 2025.

• The DREAM pivotal study met all primary and secondary endpoints, demonstrating Genio's efficacy and safety for OSA patients.

• U.S. commercial launch preparations included building a specialized team, establishing reimbursement pathways, and expanding executive leadership.

• International expansion continued, with launches in the U.K. and UAE and ongoing growth in Germany.

• FDA PMA application for Genio system is nearing conclusion, with approval expected by end of Q1 2025.

Financial highlights

• Q4 2024 revenue was EUR 1.3 million, with EUR 600,000 deferred due to disposable patch revenue recognition changes.

• Full-year 2024 revenue reached EUR 4.5 million, with an 18% increase over 2023.

• Q4 2024 operating loss was EUR 18.3 million, up from EUR 10.8 million in Q4 2023, driven by increased R&D and U.S. commercial investments.

• Cash and financial assets at year-end 2024 totaled EUR 85.6 million, up from EUR 57.7 million at year-end 2023, bolstered by a EUR 24.6 million ATM equity raise.

• Q4 2024 gross margin was 73%, up from 60% in Q4 2023; full-year 2024 gross margin was 66%.

Outlook and guidance

• FDA approval for Genio is expected by the end of March 2025, with a U.S. launch to follow immediately.

• The U.S. will be the primary focus for 2025, with plans to scale the commercial team and expand into new international markets.

• Commercial payer coverage is anticipated to begin in Q3 or Q4 2025, with Medicare coverage expected from launch.

• Positioned to address significant U.S. market opportunity for moderate to severe OSA patients.