EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU  AUSTIN, Texas, November 20, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system, further strengthening the company’s market leadership in robotic focal therapy for prostate cancer. ...

EDAP TMS (NasdaqGM:EDAP) 2025 Conference November 18, 2025 11:30 AM ET Company ParticipantsRyan Rhodes - CEONone - Video NarratorKen Mobeck - CFOConference Call ParticipantsMatthew Aspro - Senior Associate and US Medtech Equity Research AnalystMatthew AsproAll right, good afternoon. My name is Matthew Aspro. I'm with our U.S. MedTech Equity Research team here at Jefferies. With us, we have Ryan Rhodes, the CEO, and Ken Mobeck, the CFO of EDAP. We're going to kick it off with a quick presentation and then so ...

Core Insights - EDAP TMS SA will present at the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, with CEO Ryan Rhodes and CFO Ken Mobeck hosting 1x1 investor meetings [1][2] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [3] - The company introduced the Focal One® system, a leading prostate focal therapy, which is controlled by urologists and has potential applications beyond prostate cancer [3]

Financial Data and Key Metrics Changes - The company reported global revenues of $16.1 million for Q3 2025, marking the second consecutive quarter of record overall quarterly revenue [2] - HIFU revenue reached $7.7 million, a 57% increase compared to Q3 2024 [2] - Total revenue for Q3 2025 was EUR 13.9 million, a 6% increase from EUR 13.1 million in Q3 2024 [11] - Gross profit for Q3 2025 was EUR 6 million, with a gross margin of 43%, up from 39.4% in the same period last year [12][14] - Net loss for Q3 2025 was EUR 5 million, an improvement from a net loss of EUR 6.4 million in Q3 2024 [15] Business Line Data and Key Metrics Changes - HIFU business grew 49% year-over-year, driven by six capital sales in Q3 2025 compared to three in the prior year [11][12] - Focal One placements increased by 167% year-over-year, with eight placements in Q3 2025 [3] - Focal One procedures in the US grew more than 15% year-over-year, indicating a return to double-digit growth [3][4] Market Data and Key Metrics Changes - The company is seeing meaningful progress in reimbursement coverage, particularly among Medicare Advantage providers [4] - The latest hospital and physician payment rules from CMS reinforce the use case of HIFU, providing a clear reimbursement pathway [5] Company Strategy and Development Direction - The company aims to make Focal One the standard of care for localized prostate cancer, focusing on expanding clinical adoption and market access [2][18] - Plans to expand into new clinical indications, including benign prostatic hyperplasia (BPH) and endometriosis, are underway [6][8] - The company maintains financial guidance for 2025, expecting core HIFU business revenue growth of 26%-34% [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, supported by strong clinical evidence and expanding market access [18] - The company is focused on accelerating adoption and utilization across its Focal One install base while maintaining a disciplined investment approach [18] Other Important Information - The company received the first tranche of EUR 11 million from the European Investment Bank, aimed at supporting strategic investments in HIFU [16][22] - The company is monitoring the impact of US tariff policies, estimating a full-year impact of EUR 900,000 [17] Q&A Session Summary Question: Details on the EIB deal and its use - Management indicated that proceeds from the EIB deal will be used for product development, clinical development, and commercial growth, primarily focused on the HIFU core business [22] Question: Coverage of US Focal One procedures and expected growth - Management noted that the procedure mix includes Medicare patients, Medicare Advantage plan patients, and commercial patients, with positive trends in Medicare Advantage coverage expected to drive volume growth [23] Question: Expectations for Q4 given typical seasonal softness - Management reiterated guidance for 2025, confident that Q4 numbers will align with year-end targets of $58 million to $62 million [24]

Revenue Performance - Third quarter 2025 total revenue was €13.9 million (US $16.1 million), a 6% increase compared to €13.1 million (US $14.4 million) in Q3 2024[15] - HIFU business revenue for Q3 2025 was €6.7 million (US $7.7 million), representing a 49% year-over-year increase from €4.5 million (US $4.9 million) in Q3 2024[13] - Non-core business revenue for Q3 2025 was €7.2 million (US $8.4 million), a decline from €8.6 million (US $9.8 million) in Q3 2024, reflecting a strategic focus on HIFU[14] - Year-to-date HIFU revenue for the nine months ended September 30, 2025, was €21.3 million (US $23.9 million), a 42% increase from €15.1 million (US $16.3 million) in the same period of 2024[19] - For the nine months ended September 30, 2025, total revenues were €43,480 thousand, slightly down from €43,797 thousand in the same period of 2024[31] Profitability and Loss - Gross profit for Q3 2025 was €6.0 million (US $6.9 million), with a gross profit margin of 43%, up from 39% in Q3 2024[16] - Gross profit for Q3 2025 was €5,972 thousand, up 16% from €5,154 thousand in Q3 2024, resulting in a gross margin of 43%[30] - Net loss for Q3 2025 was €5.0 million (US $5.8 million), or (€0.13) per share, an improvement from a net loss of €6.4 million (US $7.0 million), or (€0.17) per share, in Q3 2024[18] - Net loss for Q3 2025 decreased to €5,014 thousand from €6,399 thousand in Q3 2024, reflecting a 22% improvement[30] - Operating loss for the nine months ended September 30, 2025 was €16,691 thousand, compared to €16,796 thousand in the same period of 2024, indicating a marginal improvement[31] Operational Metrics - Focal One system placements increased by 167% year-over-year, with six systems sold in Q3 2025 compared to three in Q3 2024[7][13] - U.S. Focal One HIFU procedures grew by 15% year-over-year, indicating a return to double-digit growth[9][13] - The company expects core HIFU business revenue to grow between 26% to 34% year-over-year for 2025[12] Financial Position - Cash and cash equivalents decreased to €10,567 thousand as of September 30, 2025, down from €29,836 thousand at the end of 2024[33] - Total assets as of September 30, 2025 were €61,464 thousand, a significant decrease from €86,063 thousand at the end of 2024[33] - Research and development expenses for the nine months ended September 30, 2025 were €6,749 thousand, an increase from €5,862 thousand in the same period of 2024[31] Financing - The company secured a €36 million credit facility from the European Investment Bank to support the expansion of the Focal One platform[8][10] Share Information - The average number of shares used in the computation of basic and diluted EPS for Q3 2025 was 37,438,630, compared to 37,233,406 in Q3 2024[30] - The company reported a net cash used in operating activities of €12,473 thousand for the nine months ended September 30, 2025, compared to €13,584 thousand in the same period of 2024[34]

Core Insights - EDAP TMS SA reported record-breaking revenue performance in Q3 2025, driven by a 167% year-over-year increase in Focal One system placements and a 49% growth in HIFU revenue [2][7][9] - The company is experiencing a paradigm shift in prostate cancer management, with increasing demand for non-invasive treatment options among urologists [2] - A €36 million credit facility agreement with the European Investment Bank was finalized to support the expansion of the Focal One platform [3][8] Financial Performance - Total revenue for Q3 2025 was €13.9 million (US $16.1 million), a 6% increase from €13.1 million (US $14.4 million) in Q3 2024 [11] - HIFU business revenue reached €6.7 million (US $7.7 million), up 49% from €4.5 million (US $4.9 million) in the same period last year [9] - Non-core business revenue declined to €7.2 million (US $8.4 million) from €8.6 million (US $9.8 million) year-over-year, reflecting a strategic focus on high-growth opportunities in Focal Therapy [10] Operational Highlights - The company sold six Focal One systems in Q3 2025, compared to three in Q3 2024, indicating strong market adoption [9] - Gross profit for Q3 2025 was €6.0 million (US $6.9 million), with a gross profit margin of 43%, up from 39% in Q3 2024 [12] - Operating loss for Q3 2025 was €4.9 million (US $5.7 million), an improvement from a loss of €5.8 million (US $6.4 million) in the same period last year [13][14] Year-to-Date Results - For the nine months ended September 30, 2025, total revenue was €43.5 million (US $48.8 million), a slight decrease of 0.7% compared to €43.8 million (US $47.6 million) in the same period of 2024 [16] - HIFU business revenue for the nine months was €21.3 million (US $23.9 million), a 42% increase from €15.1 million (US $16.3 million) in 2024 [14] - The net loss for the nine months was €17.7 million (US $19.8 million), or (€0.47) per share, compared to €17.1 million (US $18.5 million), or (€0.46) per share, in the same period of 2024 [18] Future Outlook - The company expects core HIFU business revenue to grow between 26% to 34% year-over-year for 2025, while non-core ESWL and Distribution business revenue is anticipated to decline by 25% to 30% [5] - The Focal One pipeline continues to expand, reflecting growing demand and effective execution by the commercial and clinical teams [3]

Core Points - EDAP TMS SA, a leader in robotic energy-based therapies, will present at the Jefferies Global Healthcare Conference in London on November 18, 2025 [1] - The presentation will be led by CEO Ryan Rhodes and will include 1x1 investor meetings [1] - The conference will take place from November 18-20, 2025, at the Waldorf – Aldwych [2] Company Overview - EDAP TMS SA specializes in developing, manufacturing, promoting, and distributing minimally invasive medical devices using ultrasound technology [3] - The company is known for its Focal One® system, which is a leading prostate focal therapy controlled by urologists, with potential applications beyond prostate cancer [3] - EDAP TMS aims to combine advanced imaging, robotics, and precise non-invasive energy delivery in its medical devices [3]

Core Insights - Several biotech and healthcare stocks experienced significant after-hours trading gains due to clinical updates, strategic deals, and regulatory milestones [1] Company Summaries - **Genenta Science S.p.A. (GNTA)**: Shares closed at $2.40, down 27.71% during regular trading, but rebounded to $2.45, up 2.08% in after-hours. The volatility was driven by a $15 million registered direct offering and a strategic collaboration announcement [2] - **EDAP TMS S.A. (EDAP)**: Closed at $1.81, down 22.58%, but rose 8.29% to $1.96 in after-hours trading. The recovery appears technical, with no new news, and is supported by upcoming investor meetings at the UBS Global Healthcare Conference [3] - **BridgeBio Pharma Inc. (BBIO)**: Ended regular trading at $64.50, up 1.48%, and climbed 6.71% to $68.83 after hours. The increase reflects anticipation for Phase 3 CALIBRATE trial results for ADH1, with topline data expected on October 29 [4] - **OrthoPediatrics Corp. (KIDS)**: Closed at $16.91, down 0.29%, but surged 6.45% to $18.00 after releasing Q3 financial results, reporting a GAAP loss per share of $(0.50) despite 12% revenue growth [5][6] - The company raised its full-year 2025 revenue guidance to $233.5 million to $234.5 million, indicating projected growth of 14% to 15% compared to the prior year [7] - **Modular Medical Inc. (MODD)**: Dipped 1.30% to $0.5392 but rallied 5.38% to $0.5682 after hours following the successful completion of its Stage 1 ISO 13485:2016 audit, a key step toward CE Mark certification [8] - **Vivani Medical Inc. (VANI)**: Rose 3.09% to $1.67 and added 3.65% to $1.7310 after closing a $15.7 million capital raise, which included a registered direct offering and private placement, indicating insider confidence [9] - **Amarin Corp. plc (AMRN)**: Slipped 1.56% to $18.94 but rebounded 5.07% to $19.90 after the FDA revised fenofibrate drug labeling, which may favor Amarin's Vascepa in the lipid management space [10]

Core Insights - EDAP TMS SA will participate in the UBS Global Healthcare Conference, hosting 1x1 investor meetings on November 10, 2025 [1][2] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [3] - The company introduced the Focal One® system, a leading prostate focal therapy, which is controlled by urologists and has potential applications beyond prostate cancer [3]

Core Points - EDAP TMS SA will announce its third quarter financial results for 2025 on November 6, 2025, before market opening [1] - A conference call and webcast will be hosted by key executives including the CEO, CFO, and Chief Accounting Officer on the same day at 8:30 am EST [2][3] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology for various medical conditions [4] - The company has introduced the Focal One system, which is a leading prostate focal therapy device controlled by urologists, with potential applications beyond prostate cancer [4]