Onward Medical (ONWD) Q2 2026 earnings summary

Executive summary

• 159 ARC-EX systems sold or supplied in H1 2026, representing up to 430% year-over-year growth, with robust home use demand and presence in over 150 clinics globally, including US Veterans Affairs.

• First half revenue reached EUR 4.2 million, up from EUR 1.2 million in H1 2025, driven by ARC-EX commercialization and expansion.

• Significant clinical progress: first participant enrolled and implanted in Empower BP pivotal study for ARC-IM, two additional ARC-BCI implants (seven total), and EIGER feasibility study launched.

• Cash balance at end of H1 was EUR 81.5 million, bolstered by EUR 40.6 million in new equity capital.

• New EUR 50 million debt facility from BlackRock replaced previous lender, extending cash runway into Q1 2028.

Financial highlights

• H1 2026 revenue: EUR 4.2 million (EUR 3.4 million product revenue), with ARC-EX US sales at EUR 2.9 million and European sales at EUR 0.5 million.

• Gross profit: EUR 2.9 million (~69-70% margin).

• Operating expenses: EUR 26.3 million; operating loss: EUR 23.3 million; net loss: EUR 24.7 million.

• Cash position at June 30, 2026: EUR 81.5 million, up from EUR 68.1 million at year-end 2025.

• Equity increased to EUR 71.9 million, mainly from the April 2026 capital raise.

Outlook and guidance

• Focus on scaling ARC-EX commercialization, expanding home use, and accelerating European market entry.

• Continued execution of Empower BP pivotal study, with interim readout expected by spring 2027.

• Preparing for first-in-human ARC-IM study for bladder function and additional feasibility studies for Parkinson's and stroke.

• Regulatory approval for ARC-IM targeted by end of 2028, with commercial launch in early 2029.

• No formal sales guidance issued due to early commercialization stage and expected seasonality.