Onward Medical (ONWD) Q1 2025 TU earnings summary

Executive summary

• Achieved initial U.S. commercial launch of ARC-EX neuromodulation system, meeting Q1 sales target with 10 units sold and strong demand, supported by over 3,000 global leads and a new field organization.

• Advanced technology pipeline with successful BCI implants, first in-human ARC-IM lumbar lead, and new studies in Parkinson's and stroke, supported by grants from the Michael J. Fox Foundation and U.S. Department of Defense.

• Published PATHFINDER II study showing sustained functional improvements after one year of ARC-EX therapy for spinal cord injury patients.

• Established a U.S. ADR program to enhance investor access and broaden shareholder base, increasing stock liquidity.

• Named one of Fast Company's world-changing ideas for 2025 and featured on CBS 60 Minutes, increasing visibility.

Financial highlights

• Q1 2025 revenue reached €0.4M, driven by initial ARC-EX sales in the U.S.

• Ended the quarter with a net cash position of €50.5M as of March 31, 2025; Q1 cash burn was €9.5M.

• Grant income was negligible in the quarter.

Outlook and guidance

• Expects home use authorization for ARC-EX in the U.S. and CE Mark for Europe by year-end, enabling broader commercialization.

• Targeting up to 30 ARC-EX units sold in H1 2025, with significant acceleration in revenue and system sales anticipated in H2.

• Planning to commence pivotal Empower BP study for ARC-IM in the U.S. and Europe in 2025 and expand implants for SCI and Parkinson's disease.

• Additional BCI implants and new studies in stroke expected in the next 12 months.