Onward Medical (ONWD) Q2 2025 earnings summary

Executive summary

• Achieved all commercial objectives for the phased U.S. launch of ARC-EX, selling 30 units in H1 2025, with strong demand and positive user feedback following FDA clearance.

• Advanced clinical pipeline with IDE approval for the ARC-IM Empower BP pivotal study, first human lumbar lead implant, and successful ARC-BCI implants; expanded with new grants and partnerships.

• Ended H1 2025 with revenues, cash balance, and financial profile in line with expectations.

• Focused on near-term profitability and capital efficiency, leveraging grant funding for pipeline advancement.

Financial highlights

• Revenue for H1 2025 reached €1.21M, up from €0.2M in H1 2024, driven by ARC-EX System sales.

• Operating loss for H1 2025 was €21.0M, compared to €19.0M in H1 2024, reflecting higher commercialization expenses.

• Net loss for H1 2025 totaled €21.2M, versus €18.3M in H1 2024.

• Cash position at June 30, 2025 was €40.9M, supporting ongoing operations and clinical programs.

• Equity at June 30, 2025 was €27.7M, down from €48.0M at year-end 2024, mainly due to operating losses.

Outlook and guidance

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

• Projecting sales acceleration in H2 2025, targeting over 150 units sold and penetration of 100+ clinics by year-end, in line with analyst consensus.

• Empower BP pivotal study enrollment to begin in H2 2025, with interim analysis expected in H2 2026 and potential commercial launch in H2 2028.

• Additional clinical milestones include first-in-human studies for bladder dysfunction and further BCI therapy implants.

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