Focal Therapy

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EDAP TMS (EDAP) 2025 Conference Transcript
2025-06-05 21:20
EDAP TMS (EDAP) 2025 Conference June 05, 2025 04:20 PM ET Speaker0 Okay. Alright. Good afternoon. My name is Michael Sarcone. I'm an analyst on the US Medical Supplies and Devices team, this is day two of the Jefferies twenty twenty five New York Healthcare Conference. This is a session with EDAP Focal One. And with us from the company, we've got Ryan Rhodes, CEO Ken Moback, CFO and John Francis who heads the IR function. Ryan Rhodes is going to give a presentation, some prepared commentary and then we'll o ...
EDAP TMS(EDAP) - 2025 Q1 - Earnings Call Transcript
2025-05-15 13:30
Financial Data and Key Metrics Changes - HIFU revenues for Q1 2025 were EUR 6.2 million, an increase of 6.8% compared to EUR 5.8 million in Q1 2024 [11][24] - Total worldwide revenue for Q1 2025 was EUR 13.6 million, a decrease of 9.1% from EUR 14.9 million in the same period in 2024 [12][25] - Gross profit for Q1 2025 was EUR 5.7 million, down from EUR 6.4 million in Q1 2024, with a gross profit margin of 42% compared to 42.8% year-over-year [25][26] - Net loss for Q1 2025 was EUR 7.1 million or EUR 0.19 per diluted share, compared to a net loss of EUR 4.5 million or EUR 0.12 per diluted share in the prior year [27] Business Line Data and Key Metrics Changes - The company placed nine Focal One systems in Q1 2025, a record for any first quarter, including six cash sales and three operating leases [4][6] - U.S. procedures grew approximately 4% over Q1 2024, despite longer review and approval times for Medicare Advantage patients [12][13] Market Data and Key Metrics Changes - Four cash sales of Focal One systems were completed outside the U.S. in Q1 2025, indicating growing international demand [11] - The company noted that over half of the National Comprehensive Cancer Network (NCCN) member institutions now have access to the Focal One platform [10] Company Strategy and Development Direction - The company aims to become the global leader in HIFU focal therapy, focusing on growing its core HIFU business and expanding clinical data support [4][6] - The launch of the new Focal One I robotic HIFU system is expected to enhance technological leadership and meet future needs of surgeons [22][31] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the payer landscape, particularly with Medicare Advantage plans, but noted progress in appeals and approvals [35][38] - The company reiterated its 2025 revenue guidance, expecting HIFU revenue growth between 16% and 25% year-over-year, while non-core segments are projected to decline [30][41] Other Important Information - The company received CE Mark approval for the treatment of deep infiltrating endometriosis, marking a significant regulatory milestone [14][15] - A landmark remote transatlantic Focal One robotic HIFU procedure was successfully conducted, showcasing technological advancements [17][18] Q&A Session Summary Question: Changes in payer landscape and procedure approvals - Management noted that the trends are primarily relevant to Medicare Advantage Plan patients, with ongoing efforts to improve market access and reimbursement [35][36] Question: Continued challenges in Q2 and approval processes - Management confirmed that while there is a risk of denials, notable progress in appeals is being made, with a majority of appeals resulting in approvals [38][39] Question: HIFU sales growth guidance assumptions - The guidance incorporates expected procedure growth and assumes that payer challenges may recede in the second half of the year [40][41] Question: Marketing plans for endometriosis after CE Mark approval - The company is in a controlled market entry phase in CE Mark countries and is preparing for broader launch based on clinical data [44][46]