EBR Systems (EBR) Q2 2025 TU earnings summary

Executive summary

• Achieved FDA approval for the WiSE CRT System, the first leadless left ventricular pacing device, in April 2025, and completed initial commercial implants at major U.S. centers.

• Secured maximum NTAP reimbursement from CMS for inpatient use and preliminary TPT approval for outpatient Medicare reimbursement, both effective October 2025.

• Raised A$75.9m (US$46.5m) through institutional placement and rights offering to support commercialization.

• Ended Q2 2025 with US$87.2m in cash, cash equivalents, restricted cash, and marketable securities.

Financial highlights

• Q2 2025 revenue was $169,704, up from $0 in Q2 2024, reflecting initial commercial sales post-FDA approval.

• Net loss for Q2 2025 was $11.97m, a 4.1% increase year-over-year; net loss for the first half was $22.52m, up 9.1% year-over-year.

• Gross margin for Q2 2025 was 50%, positively impacted by use of previously expensed clinical trial inventory.

• Operating expenses for Q2 2025 were $11.2m, up 4.4% year-over-year, with a 61% increase in SG&A offset by a 20% decrease in R&D.

• Adjusted EBITDA for Q2 2025 was $(10.3)m, compared to $(9.5)m in Q2 2024.

Outlook and guidance

• Limited market release of WiSE CRT System in the U.S. to begin in Q4 2025, targeting high-volume centers and leveraging new reimbursement pathways.

• Full commercial rollout planned for 2026, with international expansion dependent on regulatory and reimbursement approvals.

• Management expects current liquidity to fund operations into Q1 2027, with ongoing investments in sales, marketing, and clinical activities.