EDAP TMS reports Q4 EPS (15c), consensus (5c)

Reports Q4 revenue $21.3M, consensus $19.66M. “We are pleased to report strong revenue and system placements in the fourth quarter and full-year 2023, reflecting growing demand for Focal One and ExactVu,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “Focal One’s best-in-class robotic HIFU platform, attractive reimbursement, and the continued investments we are making in our regional clinical teams are all helping to drive demand for our technology among both academic and community hospitals. The continued robust growth in U.S. Focal One HIFU procedures also speaks to the growing number of urologists who recognize the value of robotic HIFU in the management of prostate cancer. By providing a non-invasive, non-surgical, and radiation-free treatment approach with excellent oncologic outcomes, we are seeing growing patient awareness of the Focal One treatment option, which we anticipate will provide further momentum for our business. “Looking ahead, I believe 2024 is shaping up to be another strong year for EDAP. We anticipate continued growth and adoption of Focal One among urologists, further establishing EDAP as the leading company in therapeutic robotic HIFU applications for prostate cancer. I’m also excited about the opportunities for our pipeline, as we recently announced the FDA’s granting of Breakthrough Device designation for Focal One for the treatment of deep infiltrating endometriosis. With enrollment in our Phase 3 study recently completed, we expect our rectal endometriosis program to gain visibility in 2024, as we seek to address a significant unmet need in women’s health with Focal One robotic HIFU therapy.”