Onward Medical (ONWD) Q3 2025 earnings summary

Executive summary

• Achieved EUR 1.7 million in Q3 revenue, surpassing EUR 1.5 million for the first time, with 40 ARC EX units sold and over 60 U.S. clinics now equipped.

• Secured CE mark and FDA 510(k) clearance for ARC EX home use, enabling expansion into Europe and U.S. home markets, and completed UK MHRA registration.

• Raised over EUR 50 million in new equity, extending cash runway into Q1 2027 and strengthening the balance sheet.

• Strengthened leadership team with key executive hires in commercial, finance, and clinical roles.

• Initiated pivotal Empower BP study for ARC-IM System after FDA IDE approval, with first patient enrollment expected before year-end.

Financial highlights

• Q3 revenue reached EUR 1.7 million, reflecting strong commercial execution and demand.

• Q3 cash burn was EUR 8 million, driven by commercialization, R&D, and clinical preparation.

• Net cash at end of September was EUR 32.9 million; post-October capital raise, net cash increased to EUR 77.7 million.

• Majority of device sales are outright purchases rather than rentals.

Outlook and guidance

• First commercial sale in Europe and first participant enrollment in Empower BP pivotal study expected by year-end.

• Revenue consensus for next year is low to mid-teens in EUR millions, more than doubling or tripling year-over-year.

• Additional ARC-IM and ARC-BCI implants planned to explore new indications, including Parkinson's disease.

• Cash burn expected to remain steady this year, with growth next year due to commercialization and clinical trials.