EDAP TMS S.A. ((EDAP)) has held its Q3 earnings call. Read on for the main highlights of the call.
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EDAP TMS S.A. recently held its earnings call, revealing a mixed sentiment among stakeholders. The company celebrated significant achievements in revenue growth and clinical advancements within its High-Intensity Focused Ultrasound (HIFU) segment. However, challenges persist, particularly in noncore areas where decreased performance, ongoing operating losses, and tariff impacts have affected financial outcomes.
Record Global Revenues
EDAP TMS reported record global revenues of USD 16.1 million, marking the second consecutive quarter of record-breaking overall quarterly revenue. This achievement underscores the company’s robust performance and strategic focus on expanding its market presence.
Significant HIFU Revenue Growth
The HIFU segment experienced remarkable growth, with revenues reaching USD 7.7 million, a 57% increase compared to the third quarter of the previous year. This growth highlights the increasing adoption and recognition of HIFU technology in the medical field.
Focal One Placement Success
The company recorded a significant milestone with 8 Focal One placements, reflecting a 167% increase compared to the same period last year. This success demonstrates the growing demand for EDAP TMS’s innovative solutions in the medical community.
Peer-Reviewed Scientific Study
A recent study published in the Journal of International Urology and Nephrology confirmed that HIFU delivers non-inferior 10-year oncological outcomes compared to external beam radiation therapy, further validating the efficacy of EDAP TMS’s technology.
Reimbursement Progress
EDAP TMS made meaningful progress in securing reimbursement coverage with commercial payers, particularly among Medicare Advantage providers. This advancement is crucial for expanding patient access to HIFU treatments.
Endometriosis Clinical Evidence
In a Phase III randomized controlled trial, HIFU treatment showed significant improvement in symptom scores for endometriosis patients, with 85% of the sham group opting for treatment post-unblinding, showcasing the potential of HIFU in addressing this condition.
2025 Industry Award
The Focal One device received the 2025 Industry Award for innovations in Endourological Instrumentation at the World Congress of Endourology and Uro-Technology, highlighting EDAP TMS’s leadership in medical technology innovation.
Decline in Noncore Businesses
Despite successes in core areas, the company faced a 16% decline in its noncore distribution and ESWL businesses in the third quarter of 2025 compared to the previous year, indicating challenges outside the HIFU segment.
Continued Operating Loss
EDAP TMS reported an operating loss of EUR 4.9 million for the third quarter of 2025, slightly lower than the previous year, reflecting ongoing financial challenges that the company aims to address.
Inventory and Cash Decrease
The company experienced a decrease in total cash and cash equivalents, which fell to EUR 10.6 million from EUR 16.3 million in the prior quarter, signaling a need for strategic financial management.
Tariff Impact
Tariffs on goods transferred between France and the U.S. have impacted the company financially, with a year-to-date impact of approximately EUR 300,000 and a full-year estimate of EUR 900,000, highlighting external economic pressures.
Forward-Looking Guidance
Looking ahead, EDAP TMS anticipates continued growth in its core HIFU business, with expected revenue growth of 26% to 34% year-over-year. The company also foresees a decline in noncore business revenues by 25% to 30%. Despite these challenges, EDAP TMS maintains its financial guidance for the year, supported by a third-quarter gross profit of EUR 6 million and an improved gross margin of 43%.
In summary, EDAP TMS S.A.’s earnings call presented a complex picture of growth and challenges. While the company celebrates significant achievements in its HIFU segment, it continues to navigate financial hurdles in noncore areas and external economic pressures. Investors and stakeholders will be keenly watching how EDAP TMS leverages its strengths to overcome these challenges and sustain its growth trajectory.