EDAP TMS(US:EDAP)2025-08-28 13:32Financial Data and Key Metrics Changes - Global HIFU revenues reached $9.7 million, an increase of 89% year over year, driven by the placement of 12 Focal One systems, representing a 140% growth compared to Q2 2024 [4][5] - Total revenue for Q2 2025 was €16 million, a 1.6% increase from €15.8 million in Q2 2024, with HIFU revenue growing 76.8% year over year [21][22] - Gross profit for Q2 2025 was €6.8 million, with a gross margin of 42.5%, up from 37.5% in the same period last year [24] Business Line Data and Key Metrics Changes - HIFU business revenue for Q2 2025 was €8.5 million, compared to €4.8 million in Q2 2024, driven by nine capital sales versus three in the prior year [22][23] - Non-core distribution and ESWL businesses declined by 31.2% in Q2 2025 compared to Q2 2024 [21] Market Data and Key Metrics Changes - U.S. procedures grew approximately 4.8% year over year, despite challenges with Medicare Advantage plans impacting growth in certain markets [10][11] - The proposed hospital payment for the Focal One HIFU procedure in 2026 is set at $9,765, a 5.6% increase from 2025 [12] Company Strategy and Development Direction - The company is focusing on expanding its Focal One Endometriosis application, having received CE marking for HIFU in treating rectal endometriosis [14][15] - A strategic financing facility with the European Investment Bank for €36 million is expected to enhance the balance sheet and support the expansion of Focal One robotic HIFU [17][19] - Transitioning to a U.S. domestic filer starting January 1, 2026, to comply with SEC reporting rules and attract new institutional investors [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerating growth of Focal One, driven by strong clinical data and increasing awareness among patients and physicians [30] - The company updated its 2025 financial guidance, expecting core HIFU business revenue to grow between 26% to 34% year over year [29] Other Important Information - Inventory decreased to $15.5 million in Q2 2025 from €18 million at the end of Q1 2025, attributed to efficient inventory management [26] - The company is actively working with market access partners to improve pre-authorizations for Focal One procedures [11] Q&A Session Summary Question: Can you provide details on the payer issues and reimbursement situation? - Management noted improvements in reimbursement efforts, with strong collaboration with market access partners to accelerate pre-authorizations for Focal One procedures [33][34] Question: What factors does CMS consider for higher reimbursement rates? - CMS evaluates average payments, cost of service, volume of procedures, and clinical value when determining reimbursement rates [43][44] Question: Can you provide an update on the endometriosis trial? - The phase three study showed over 80% of sham arm patients opted for Focal One treatment post-unblinding, with a limited European launch currently underway [53][54] Question: How is the €36 million from the EIB intended to be used? - The funds are earmarked for accelerated commercial growth in the HIFU business and investment in clinical indications and new technologies [56][59]