EDAP TMS (FOCL) investor relations material

Executive summary

• Transitioned to a pure-play, high-growth focal therapy company, rebranding and reporting in U.S. dollars, with a strategic realignment in May 2026 to focus exclusively on the robotic focal therapy business (Focal One HIFU), discontinuing ESWL and Distribution segments.

• Achieved best-ever Q2 for HIFU capital system sales, with 13 systems sold and $13.2M in HIFU revenue, up 39% year-over-year, expanding the global install base to 184 systems.

• U.S. Focal One procedure volumes grew 47% year-over-year, reflecting strong adoption and utilization.

• Completed a corporate rebranding and launched the first commercial endometriosis program in Europe.

• Announced a $40M underwritten public offering expected to close August 14, 2026.

Financial highlights

• HIFU revenue reached $13.2M in Q2 2026, a 39% increase from Q2 2025; total revenues from continuing operations rose 54.9% to $24.8M for the first half of 2026.

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

• Operating expenses rose to $15.4M from $11.5M, with net loss impacted by a $6.3M non-cash warrant charge and $400K FX loss; net loss from continuing operations was $14.4M for Q2 2026 ($0.38/share).

• Cash and equivalents at quarter-end were $21.5M as of June 30, 2026.

• Discontinued operations revenue fell 34% to $5.6M, with gross margin at 36.4%.

Outlook and guidance

• Reiterated full-year 2026 HIFU revenue guidance of $50M–$54M, representing 34%–45% year-over-year growth.

• Confident in ability to execute strategic growth plan, accelerate commercial adoption in prostate cancer, and expand into endometriosis and BPH markets.

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