EDAP TMS Earnings Call: Achievements Amid Financial Challenges

EDAP TMS S.A. ((EDAP)) has held its Q1 earnings call. Read on for the main highlights of the call.

The recent earnings call for EDAP TMS S.A. painted a mixed picture for the company. While there were significant achievements such as record system placements and regulatory approvals, these were overshadowed by financial challenges, including a decline in overall revenue and increased net losses. The sentiment expressed during the call was one of cautious optimism, with promising strategic developments tempered by notable financial setbacks.

Record Number of Focal One Placements

In the first quarter of 2025, EDAP TMS achieved a milestone by placing nine Focal One systems, marking a record for any prior first quarter period. This achievement underscores the growing acceptance and demand for their advanced medical technology.

CE Mark Approval for New Indication

The company received CE Mark approval for using Focal One to treat posterior deep infiltrating endometriosis. This regulatory milestone opens up new avenues for the application of their technology in treating complex conditions.

Launch of Focal One i Robotic HIFU System

At the 2025 AUA Meeting, EDAP TMS launched the Focal One i System, which integrates AI and remote procedure capabilities. This innovation highlights the company’s commitment to advancing medical technology and improving patient outcomes.

Positive Clinical Trial Results

The FARP Randomized Controlled Trial delivered promising results, showing that focal ablation is non-inferior to radical prostatectomy. This finding could have significant implications for the treatment of prostate cancer.

World’s First Remote Transatlantic Procedure

EDAP TMS made history with the world’s first remote procedure conducted between Cleveland Clinic Ohio and Cleveland Clinic Abu Dhabi using Focal One. This breakthrough demonstrates the potential for remote medical procedures, expanding the reach of their technology.

Overall Revenue Decline

Despite these achievements, the company faced a 9.1% decline in total worldwide revenue, amounting to €13.6 million. This decrease was attributed to strategic shifts away from non-core segments.

Increased Operating Loss

Operating loss for the first quarter of 2025 was €6 million, compared to €4.8 million in the same period of 2024. This increase in operating loss reflects the financial challenges the company is currently facing.

Net Loss Increase

The net loss for Q1 2025 was €7.1 million, up from €4.5 million in the previous year. This increase in net loss highlights the financial hurdles that EDAP TMS needs to address moving forward.

Challenges with Medicare Advantage Plans

The company reported longer and more challenging review and procedure approvals for patients enrolled in Medicare Advantage plans, posing operational challenges that need to be overcome.

Cash and Cash Equivalents Decrease

At the end of Q1, EDAP TMS’s total cash and cash equivalents stood at €22.8 million, down from €29.8 million at the end of Q4 2024. This decrease in cash reserves is a concern that the company must manage carefully.

Forward-Looking Guidance

Looking ahead, EDAP TMS maintained its 2025 revenue guidance, expecting HIFU revenue growth between 16% and 25%, while projecting a decline in non-core businesses by 20% to 25%. The company emphasized its commitment to expanding technological leadership and market presence in focal therapy, with notable developments such as the launch of the new Focal One i Robotic HIFU System and the landmark remote transatlantic procedure.

In conclusion, EDAP TMS’s earnings call highlighted a blend of strategic achievements and financial challenges. The company is poised for growth in its core HIFU business, yet it must navigate the financial setbacks and operational hurdles that lie ahead. Investors and stakeholders will be keenly watching how EDAP TMS balances these dynamics in the coming quarters.