EBR Systems (EBR) Q4 2025 earnings summary

Executive summary

• Achieved FDA approval for leadless left ventricular pacing (WiSE CRT System) in April 2025, enabling U.S. commercial launch targeting heart failure patients unsuitable for traditional CRT.

• Commercial rollout began in June 2025, with 30 commercial implants and $1.6 million in revenue by year-end; 18 patients treated in Q4 and 25 in the first two months of the new year.

• Strong physician engagement, high demand for training, and a robust pipeline of patients awaiting treatment.

• No direct competitors in leadless left ventricular pacing; technology is complementary to major incumbents and is the only FDA-approved leadless LV pacing system.

• Established U.S. reimbursement pathways (NTAP and TPT) at a $63,300 contract price, supporting both inpatient and outpatient procedures for three years.

Financial highlights

• 2025 revenue reached $1.6 million, all from U.S. commercial sales post-FDA approval; Q4 revenue exceeded $900,000 with 18 commercial implants.

• Gross profit was $0.5 million with a 30.3% margin, aided by use of previously expensed inventory.

• Operating expenses for the quarter were $13.5 million; full-year R&D expense was $23.9 million (down 11.5% YoY), and SG&A was $22.6 million (up 101.1% YoY).

• Net loss for 2025 was $48.8 million, up 19.5% from 2024, reflecting increased investment in commercialization and R&D.

• Year-end cash, cash equivalents, and marketable securities totaled $54.2 million.

Outlook and guidance

• Focus for the year is on ramping sales execution, expanding commercial reach, and preparing for full market release in 2H 2026.

• Ongoing post-approval studies (WiSE-UP) and feasibility studies (TLC-AU) to support broader indications and market expansion.

• No forward-looking revenue or cash flow guidance provided; refer to analyst consensus for projections.

• Substantial doubt exists regarding ability to continue as a going concern without additional capital; plans to seek further funding.

• Anticipates further acceleration in patient treatments and hospital contracts.