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Onward Medical (ONWD) investor relations material

Onward Medical Q2 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q2 2025 earnings summary2 Sep, 2025

Executive summary

  • Achieved all commercial objectives for ARC-EX/RTX US launch, selling 30 units in H1 2025, meeting sales targets and expanding to 25 clinics, with strong demand and positive user feedback.

  • Advanced clinical pipeline with IDE approval for Empower BP pivotal study, first human ARC-IM Lumbar Lead implant, and additional ARC-BCI implants.

  • Maintained financial performance in line with expectations, with H1 2025 revenue of €1.2M and cash position of €40.9M at June-end.

  • Expanded regulatory submissions for ARC-EX/RTX home use and CE Mark for European commercialization.

  • Strengthened future pipeline with new grants, partnerships, and board appointments.

Financial highlights

  • H1 2025 revenue reached €1.2M, up from €0.2M in H1 2024, with gross profit of €1.0M and operating loss of €21.0M.

  • Net loss for H1 2025 was €21.2M, compared to €18.3M in H1 2024.

  • Cash position at June 30, 2025 was €40.9M, with €19.1M cash used during H1 2025.

  • Equity at June 2025 was €27.7M, down from €48.0M at year-end 2024.

  • Operating expenses increased year-over-year, mainly due to commercialization investments.

Outlook and guidance

  • Expecting FDA home use authorization and CE Mark for ARC-EX/RTX in Q4 2025, enabling European commercialization.

  • Anticipate sales acceleration in H2 2025, aiming for over 150 units sold and 100 clinics penetrated by year-end.

  • Empower BP pivotal study to begin enrollment in H2 2025, with interim analysis projected for H2 2026.

  • Additional ARC-IM and ARC-BCI implants and first-in-human studies for new indications expected in the next 12 months.

  • Current cash expected to fund operations into H1 2026; exploring options to bolster cash for future investments.

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Frequently asked questions

Onward Medical N.V. is a medical technology company focused on developing innovative therapies to restore movement, function, and independence for people with spinal cord injuries. It has developed two main technology platforms: ARCIM, an implantable neurostimulation system, and ARCEX, a non-invasive transcutaneous system. These technologies are designed to improve or restore motor functions and independence in individuals affected by spinal cord injuries through targeted spinal cord stimulation. The company is engaged in ongoing clinical trials to validate and expand the application of its technologies. Onward Medical N.V. is headquartered in Eindhoven, Netherlands, and its shares are listed on Euronext Brussels and Euronext Amsterdam.

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