The following is a summary of the EDAP TMS S.A. (EDAP) Q3 2024 Earnings Call Transcript:

Financial Performance:

• EDAP TMS S.A. reported Q3 2024 total worldwide revenue of $14.4 million, achieving an 11.6% year-over-year growth in currency-adjusted terms.

• Gross profit for Q3 was €5.2 million with a gross margin of 39.4%, showing an improvement from 35.5% in the previous year.

• Net loss for the quarter was €6.4 million, or €0.17 per diluted share, compared to a net loss of €3.9 million, or €0.11 per diluted share, in the year-ago period.

Business Progress:

• EDAP placed three new Focal One systems during Q3, including their first at Virginia Commonwealth University.

• Announced a strategic collaboration with Avenda Health, incorporating AI into the Focal One platform for prostate cancer treatment.

• Initiated a combined Phase I/II study evaluating Focal One for treating benign prostatic hyperplasia (BPH).

• Reported positive interim results in a Phase III study for treating deep infiltrating endometriosis with their robotic HIFU technology.

Opportunities:

• The continued adoption of Focal One by leading U.S. cancer treatment centers represents a significant growth opportunity.

• The favorable reimbursement rates set for 2025 by CMS for HIFU procedures bolster the financial case for greater adoption in hospitals.

Risks:

• The gradual growth in the adoption of the AI-assisted Focal One procedures and the new clinical programs can present challenges, with outcomes influencing future adoption rates.

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