EDAP TMS(EDAP) - 2025 Q4 - Annual Results

Prostate Cancer Statistics - 3.3 million American men are living with prostate cancer, with 313,780 new cases diagnosed in the U.S. annually [7] - The global market for prostate cancer treatment includes 1.5 million new cases per year, with Europe accounting for 473,011 cases and Asia for 386,424 cases [8] HIFU Treatment Insights - The annual procedure opportunity for Focal One HIFU in prostate cancer is estimated at 470,000, with Europe contributing 165,000 and Asia 130,000 [10] - HIFU demonstrates a 90% cancer control rate compared to 86% for radical prostatectomy, indicating superior functional outcomes [18] - A multicentric study shows that HIFU has equivalent 10-year survival rates compared to external beam radiation therapy (EBRT), with lower mortality rates [20] Financial Performance - Revenue for the three months ended September 30, 2025, was $16.1 million, a 12% increase from $14.4 million in the same period of 2024 [45] - Gross profit for the same period was $6.9 million, with a gross margin of 43.0%, up from 39.4% in 2024 [45] - For the nine months ended September 30, 2025, revenue reached $48.8 million, a slight increase from $47.6 million in 2024 [46] - The company reported a net loss of $19.8 million for the nine months ended September 30, 2025, compared to a net loss of $18.5 million in 2024 [46] - HIFU revenue for the nine months ended September 30, 2025, was $23.9 million, reflecting a 46% increase from $16.3 million in 2024 [46] Market Expansion and Technology - The reimbursement for HIFU procedures has increased by 90% in 2023, with a projected payment of $9,671 under the CMS Hospital Outpatient Prospective Payment System [22][23] - The physician payment for HIFU in 2026 is set at $1,087, making it a competitive option compared to other treatments [24] - The company is positioned to expand into the benign prostatic hyperplasia (BPH) market, which affects 15 million U.S. men annually [32] - The Focal One technology is integrated with advanced imaging and AI capabilities, enhancing treatment precision and efficiency [28] - The company is actively recruiting for a Phase I-II clinical study on HIFU for BPH, confirming safety and potential symptom improvement [33] Installation and Adoption Rates - Focal One systems installed in U.S. hospitals reached 87 as of December 31, 2025, with a compounded annual growth rate (CAGR) of 52% in installations [41] - Focal One procedures experienced a CAGR of 44% from 2021 to 2025, indicating strong adoption in the market [41] - The company has a growing global install base, with 254 Focal One treatment clinical sites as of December 31, 2025 [39] Cash Position - Cash and cash equivalents decreased to $12.4 million as of September 30, 2025, down from $28.4 million in 2024 [47] Regulatory Approvals - The company received CE mark certification for the treatment of posterior deep endometriosis infiltrating the rectum on March 25, 2025 [35]