• Total Revenue: EUR13.1 million, an increase of 11.6% year-over-year.
• HIFU Business Revenue: EUR4.5 million, a growth of 48.2% year-over-year.
• Distribution Business Revenue: EUR6.6 million, up from EUR6 million in the previous year.
• Litho Business Revenue: EUR2 million, down from EUR2.7 million in the previous year.
• Gross Profit: EUR5.2 million, compared to EUR4.2 million in the previous year.
• Gross Profit Margin: 39.4%, up from 35.5% in the previous year.
• Operating Expenses: EUR11 million, up from EUR9.7 million in the previous year.
• Operating Loss: EUR5.8 million, compared to EUR5.6 million in the previous year.
• Net Loss: EUR6.4 million or EUR0.17 per diluted share, compared to EUR3.9 million or EUR0.11 per diluted share in the previous year.
• Ending Inventory: EUR21 million, up from EUR15.1 million at the end of 2023.
• Total Cash and Cash Equivalents: EUR25.5 million, down from EUR43.5 million at the end of 2023.

• Warning! GuruFocus has detected 3 Warning Signs with EDAP.

Release Date: November 07, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Edap TMS SA (NASDAQ:EDAP) reported a 34% year-over-year growth in US focal one HIFU procedures, indicating strong adoption by urologists.
• The HIFI study results suggest that EDAP's HIFU technology is as effective as radical prostatectomy, with better functional outcomes.
• CMS finalized a 5.4% increase in Medicare hospital payment rates for HIFU procedures, supporting favorable reimbursement.
• The company announced a collaboration with VDA Health to launch AI-assisted focal one robotic HIFU procedures, enhancing treatment precision.
• Edap TMS SA (NASDAQ:EDAP) achieved a record third-quarter revenue of EUR13.1 million, marking an 11.6% increase from the previous year.

Negative Points

• The litho business revenue decreased to EUR2 million from EUR2.7 million in the same period last year, due to fewer lithotripsy unit sales.
• Operating expenses increased to EUR11 million, primarily due to investments in focal one commercial operations.
• The company reported a net loss of EUR6.4 million for the third quarter, compared to a EUR3.9 million loss in the previous year.
• Cash and cash equivalents decreased significantly to EUR25.5 million from EUR43.5 million at the end of 2023.
• The primary endpoint of superior reduction in acute pelvic pain in the HIFU arm of the endometriosis study was not reached.

Q & A Highlights

Q: Can you elaborate on the hospital customer pipeline and Focal One placements, particularly regarding expectations for the second half of the year? A: Ryan Rhodes, CEO: We saw good activity in the third quarter and are building our pipelines. Some sales slipped into Q4, but we still plan for a stronger second half. Engagement remains high, especially following key scientific meetings, indicating strong growth in the latter half of the year.

Q: How is the utilization per customer or account trending for Focal One procedures in the US? A: Ryan Rhodes, CEO: As we launch new Focal One programs, there's a ramp period involving training and onboarding. Hospitals are increasing procedures, supported by strong reimbursement. Clinical value is demonstrated by positive data from installed users, and some hospitals are enhancing marketing to attract more patients.

Q: Regarding the BPH study, when can we expect initial results, and what data will it include? A: Ryan Rhodes, CEO: Results from the phase one and two study are expected later next year. The study is designed to accelerate scientific findings on treatment parameters. We have three active sites and plan to expand to more, with results anticipated to be shared accordingly.

Q: Will the US clinical study for BPH mirror the French study, or will it be modified? A: Ryan Rhodes, CEO: We plan to use results from the combined phase one and two study to expand to multiple sites. Protocol design will be developed in collaboration with investigators to meet FDA requirements, aiming to accelerate the process and expand to additional sites.

Q: How long will you follow patients in the endometriosis program, and when will longer-term results be released? A: Ryan Rhodes, CEO: We can follow patients for 12 months and beyond. We've shown safety and lesion size reduction in the HIFU arm. An 85% crossover rate indicates patients returned to baseline pain scores post-unblinding. We plan to meet with the FDA by year-end to discuss recent findings and continue monitoring patients.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.