EDAP TMS (FOCL) Q2 2026 earnings summary

Executive summary

• Strategic realignment in May 2026 focused exclusively on the robotic focal therapy (Focal One HIFU) business, with ESWL and Distribution segments discontinued and held for sale, and a corporate rebranding completed.

• HIFU is now the sole continuing reportable segment, with all prior period results recast to reflect this change.

• Achieved record HIFU revenue and capital system sales, expanding the global install base to 184, and launched the first commercial endometriosis program in Europe.

• Raised $40 million in equity to support commercial growth, R&D, and new indications, with an underwritten public offering expected to close August 14, 2026.

Financial highlights

• Q2 2026 HIFU revenue reached $13.2 million, up 39% year-over-year, and $24.8 million for the first half, up 54.9%.

• Gross margin improved to 55.6% in Q2 2026 from 51.1% year-over-year.

• Operating expenses rose to $15.4 million in Q2 2026 from $11.5 million, including $0.8 million in one-time costs.

• Net loss from continuing operations was $14.4 million ($0.38/share) in Q2 2026, mainly due to warrant valuation impacts and higher operating costs.

• Cash and cash equivalents at quarter-end were $21.5 million; long-term debt increased to $37.2 million.

Outlook and guidance

• 2026 HIFU revenue guidance reiterated at $50–$54 million, representing 34%–45% year-over-year growth.

• Focus remains on commercial execution, expanding into BPH and endometriosis, and advancing AI-assisted and telecollaboration technologies.

• Expect continued gross margin improvement through cost reductions and increased procedure volumes.

• Management expects continued operating losses in the near term but believes recent capital raises provide sufficient liquidity for at least the next twelve months.