EBR Systems (EBR) Q3 2025 TU earnings summary

Executive summary

• Achieved CMS approval for both NTAP (inpatient) and TPT (outpatient) Medicare reimbursement for the WISE CRT System, effective October 1, 2025, establishing a comprehensive reimbursement pathway in the U.S.

• Commercial case volume tripled quarter-over-quarter, with 12 commercial implants during the pilot launch phase post-FDA approval.

• Limited Market Release (LMR) preparations advanced, with 8 new purchasing agreements and 14 physicians trained in Q3 2025.

• Manufacturing expansion in Santa Clara remains on track for completion in 2026.

Financial highlights

• Q3 2025 revenue was $0.512 million, up 201% from Q2 2025.

• Gross margin for Q3 2025 was 43.8%, positively impacted by use of previously expensed inventory; excluding this, gross margin would have been -25.3%.

• Net loss for Q3 2025 was $12.2 million, a 21.2% increase year-over-year; net loss for the nine months ended September 30, 2025, was $34.7 million, up 13.1% year-over-year.

• Operating expenses for Q3 2025 were $12.1 million, up 31.9% year-over-year, driven by a 103.6% increase in selling, general, and administrative expenses.

• Cash, cash equivalents, restricted cash, and marketable securities totaled $73.0 million as of September 30, 2025.

Outlook and guidance

• Management expects acceleration in site onboarding and procedure cadence in Q4 2025 as hospitals gain reimbursement certainty.

• Existing liquidity is expected to fund projected operating requirements for at least the next 12 months.