Onward Medical (ONWD) Q4 2025 earnings summary

Executive summary

• Achieved rapid commercial traction with 117 ARC-EX systems sold to over 80 U.S. clinics, representing 25% market penetration by year-end 2025, and initiated commercialization in Europe with deliveries to clinics in the Netherlands, Switzerland, Germany, and the U.K.

• Secured major regulatory milestones: FDA 510(k) clearance, CE mark, IDE approval for ARC-IM Empower BP pivotal study, and registrations in the U.K. and Switzerland.

• Advanced scientific leadership with pivotal clinical data published in Nature and Nature Medicine, and completed first human implants for ARC-IM Lumbar Lead and ARC-BCI Therapy.

• Raised over EUR 50 million in equity capital, ending 2025 with a net cash position of EUR 68.1 million, and filed an F-1 registration for a potential Nasdaq IPO.

• Strengthened leadership team and board with industry leaders and expanded C-suite.

Financial highlights

• 2025 total revenues reached EUR 5.4 million, up from EUR 1.7 million in 2024; product revenues were EUR 3.7 million, mainly from ARC-EX sales.

• Gross profit was EUR 4.4 million; product gross margin was approximately 72%.

• Operating expenses increased to EUR 45.3 million from EUR 36.6 million in 2024, reflecting investments in commercial build-out, regulatory activities, capital markets, and leadership hires.

• Net loss widened to EUR 41.8 million from EUR 35.7 million in 2024.

• Year-end cash balance was EUR 68.1 million, bolstered by a EUR 50.9 million equity raise in Q4 2025.

Outlook and guidance

• Four growth drivers for 2026–2027: additional U.S. clinic sales, VA and non-VA home use sales, and EU/rest-of-world expansion.

• Expects strong commercial results in 2026, driven by ARC-EX home use and European expansion.

• Expecting interim analysis for Empower BP pivotal study in early 2027 and potential ARC-IM commercialization in the second half of 2028.

• Plans to execute the Empower BP pivotal study and advance clinical feasibility studies for new ARC-IM and ARC-BCI indications, including bladder function, Parkinson’s disease, and stroke.

• Anticipates continued news flow, including first commercial home use sale in Europe and new clinical milestones.