IceCure(ICCM) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024, reflecting a decrease due to the absence of revenue from Terumo in 2025 [16] - Gross profit for the nine months ended September 30, 2025, was $626,000, resulting in a gross margin of 30%, down from 43% in the prior year [17] - Total operating expenses decreased to $11.5 million for the nine months ended September 30, 2025, compared to $12.2 million a year ago [17] - Net loss for the nine months ended September 30, 2025, was $10.8 million or $0.18 per share, relatively the same as the net loss of $10 million or $0.22 for the same period last year [17] - As of September 30, 2025, cash equivalents and short-term deposits were $10 million, up from $7.6 million as of December 31, 2024 [18] Business Line Data and Key Metrics Changes - The decrease in sales during the nine months ended September 30, 2025, was attributed to declines in Japan, other territories in Asia, and North America, partially offset by an increase in sales in Latin America [16] Market Data and Key Metrics Changes - The FDA granted marketing authorization for the ProSense cryoablation system to treat low-risk breast cancer, which is expected to address a population of approximately 200,000 patients annually in the U.S. [8][25] - The indication covers about 46,000 women aged 70 and older diagnosed each year, plus an estimated 88,000 patients who are not candidates for surgery [8][24] Company Strategy and Development Direction - The company is focused on expanding ProSense installations and utilization in the U.S. following FDA authorization, with plans to increase the number of commercial sites [9][10] - IceCure aims to implement its sales and marketing strategy targeting a patient population of about 200,000 women annually, while also expanding clinical evidence and improving reimbursement [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that the FDA marketing authorization has dramatically changed the company's growth trajectory and is optimistic about the future [27] - The company is in a strong financial position to continue executing across regulatory, clinical, and commercial initiatives, with a cash balance of $11.8 million as of October 31, 2025 [18] Other Important Information - The company has secured a distribution agreement in Brazil with expected sales of $6.6 million over the next five years [12] - ProSense has received regulatory approval in Israel for breast cancer and other indications, and the company has a strong intellectual property portfolio [12] Q&A Session Summary Question: Status of FDA approval for the post-market study - Management confirmed that the protocol has been submitted to the FDA and they are in interactive communication to finalize it, with expectations for approval by early next year [20] Question: Update on clinical sites for the post-market study - Management indicated that about 20 sites have been identified, with plans to finalize the protocol and recruit patients by summer 2026 [21] Question: Clarification on the addressable market for cryoablation - Management elaborated that the addressable market includes 46,000 low-risk patients over 70, 88,000 non-surgical candidates, and 63,000 patients with benign tumors, totaling over 200,000 potential patients annually in the U.S. [22][24][25]