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EBR Systems (EBR) investor relations material
EBR Systems Q2 2025 TU earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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.
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