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 in U.S. rehab clinics by year-end 2025.

• Expanded into Europe with CE Mark and initial sales in the Netherlands, Italy, U.K., Germany, and Switzerland.

• Secured major regulatory milestones: FDA 510(k) clearance for U.S. home use, CE mark, IDE approval, and registrations in the U.K. and Switzerland.

• Advanced clinical pipeline with pivotal Empower BP study, first human ARC-IM implants, and published pivotal data in Nature and Nature Medicine.

• Raised over EUR 50 million in equity capital, strengthened leadership and board, and filed F-1 registration for a potential Nasdaq IPO.

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, with marketing and market access expenses more than doubling to EUR 8.1 million.

• 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.

• Empower BP pivotal study progressing, with interim analysis expected in early 2027 and potential ARC-IM commercialization in the second half of 2028.

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

• Filed F-1 registration for a potential Nasdaq IPO within 12–18 months, subject to market conditions.