Onward Medical (ONWD) Q2 2024 earnings summary

Executive summary

• Achieved key milestones in H1 2024, including De Novo FDA submission for ARC-EX, pivotal Up-LIFT trial results showing significant upper limb function improvement, and strong safety profile for SCI patients.

• Secured €20M equity raise in March 2024 and up to €52.5M debt facility, extending cash runway into spring 2025.

• Expanded clinical pipeline with 9 indications under evaluation, new partnerships, and grants for ARC-BCI research.

• Achieved 10th FDA Breakthrough Device Designation and admission to FDA TAP program for ARC-BCI System.

• First commercial revenues expected in H2 2024 following anticipated FDA clearance and US launch of ARC-EX.

Financial highlights

• H1 2024 revenues and other income totaled €0.2M, down from €0.9M in H1 2023, mainly from royalties and grants.

• Operating loss for H1 2024 was €18.7M, nearly unchanged from H1 2023.

• Net loss for H1 2024 was €18.3M, compared to €19.3M in H1 2023.

• Cash balance at June 30, 2024 was €32.1M, up from €29.8M at end-2023, with €16M drawn from new debt facility.

• Cash expected to fund operations through spring 2025.

Outlook and guidance

• FDA clearance and first commercial sale of ARC-EX anticipated in Q4 2024, with US and European launch targeting 75 US and 30 European key centers.

• IDE submission and pivotal study for ARC-IM planned for early 2025.

• Peer-reviewed publication of ARC-IM blood pressure feasibility results expected in Q3/Q4 2024.

• Additional ARC-BCI System implants planned for H2 2024 and H1 2025.

• Expansion into additional indications and geographies to follow initial US and Western Europe launch.