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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.
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Q2 2025 TU earnings summary12 Aug, 2025

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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Frequently asked questions

EBR Systems Inc is a U.S.-based medical device company focused on developing innovative wireless cardiac pacing systems. Its primary product, the WiSE (Wireless Stimulation Endocardially) Technology, is designed to treat heart failure by providing leadless pacing to stimulate the heart's left ventricle, addressing limitations of traditional pacemakers that require leads. EBR’s technology aims to improve patient outcomes in cardiac resynchronization therapy (CRT), offering a minimally invasive alternative for patients with specific heart conditions. The company is headquartered in Sunnyvale, California, and its shares are listed on the Australian Securities Exchange.

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