EBR Systems 2025 10-K: $1.62M revenue, $(0.12) EPS
I'm LongbridgeAI, I can summarize articles.EBR Systems reported $1.617 million in revenue for 2025, following FDA PMA approval and U.S. commercialization, resulting in a net loss of $48.758 million or $(0.12) per share. The revenue came from initial commercial implants and early international battery sales. The loss was attributed to high R&D and SG&A expenses during scale-up. The company trained 33 physicians and signed 21 purchase agreements to support adoption, focusing on U.S. high-volume hospitals for commercial expansion.
EBR Systems reported $1.617 million in revenue for 2025 following FDA PMA and the start of U.S. commercialization, producing a net loss of $48.758 million or $(0.12) per share as the company continues to invest heavily in R&D and commercial expansion. Revenue reflects initial commercial implants and early international battery sales, while the loss was driven by operating expenses including R&D and SG&A during scale-up. Gross profit was $0.490 million, with margins affected by inventory accounting and manufacturing scale-up.
Financial Highlights
- Revenue: $1.617 million (recognized from U.S. commercial sales after FDA approval in April 2025)
- Gross Profit: $0.490 million (gross margin 30.3%; would be -26.8% excluding previously expensed clinical inventory)
- Operating Income (Loss from operations): $(46.087) million, driven by R&D and SG&A expenses
- Net Income (Net loss): $(48.758) million, a loss increase of $7.959 million (19.5%) versus prior year
- Net Income Per Share: $(0.12) basic and diluted; weighted-average shares 417.327 million
Business Highlights
- FDA approval & commercial launch: Received U.S. FDA PMA in April 2025 and began U.S. commercialization in Q2 2025, enabling commercial implants.
- Initial commercial activity: Generated revenue from 33 implants across 11 U.S. hospitals and initial international battery sales.
- Clinical and training momentum: Trained 33 physicians and signed 21 purchase agreements with target lower motor region (LMR) sites to support adoption.
- Manufacturing and inventory: Capitalized inventory and scaled manufacturing efforts to improve product availability, a shift that pressures near-term margins but supports commercialization.
- Commercial expansion focus: Prioritizing U.S. high-volume hospitals first, with selective international market expansion contingent on regulatory and reimbursement review.
Original SEC Filing: EBR Systems, Inc. [ EBRCZ ] - 10-K - Mar. 18, 2026