Onward Medical (ONWD) Q4 2024 earnings summary

Executive summary

• Achieved FDA De Novo clearance and first commercial sales of ARC EX system for spinal cord injury therapy in 2024, marking a pivotal year for US commercialization.

• Secured over €70M in new capital through equity raises and debt financing, ending 2024 with €60M net cash.

• Formed a strategic partnership with Ottobock, now the largest shareholder (~10%), and gained exclusive rights to leading BCI technology.

• ARC EX pivotal trial met all endpoints, showing significant improvements in hand function and quality of life for SCI patients.

• Named one of TIME Magazine's Best Inventions of 2024.

Financial highlights

• Total revenue and other income reached EUR 1.7M in 2024, up from EUR 0.5M in 2023, mainly due to grants and initial product sales.

• Operating loss for 2024 was EUR 34.9M, slightly improved from EUR 35.5M in 2023; net loss was EUR 35.7M.

• Year-end cash position was EUR 60M, nearly double the prior year, supported by equity and debt fundraising.

• Cash burn from operations was EUR 36M in 2024.

• Interest-bearing loans at year-end: EUR 14M; equity at year-end: EUR 48.1M.

Outlook and guidance

• 2025 expected to be catalyst-rich, with goals including FDA home use authorization, CE Mark, and first commercial sales outside the US.

• Anticipates IDE approval and first enrollment for Empower BP pivotal study, and further BCI implant announcements.

• Will expand US field organization and establish sales channels outside the US in 2025.

• No change to analyst consensus or guidance; commercialization and organizational ramp-up proceeding as planned.

• Next business update scheduled for June 17, 2025.