Q3 2025 Icecure Medical Ltd Earnings Call Transcript
Key Points
- Icecure Medical Ltd (ICCM) received FDA marketing authorization for its ProSense cryoablation system to treat low-risk breast cancer, marking a significant milestone for the company.
- The FDA authorization positions ProSense as the only cryoablation system cleared in the US for breast cancer, creating a substantial barrier to entry for competitors.
- The company is experiencing growing interest from US clinicians, including breast surgeons and radiologists, which is expected to drive increased installation and utilization of ProSense.
- Icecure Medical Ltd (ICCM) has expanded its global presence, with recent approvals in Switzerland and ongoing regulatory efforts in Japan with Terumo Corporation.
- The company has a strong financial position, with $11.8 million in cash as of October 31, 2025, supported by a successful rights offering and market offering facility.
- Revenue for the first nine months of 2025 decreased to $2.1 million from $2.4 million in the same period in 2024, with declines in sales in Japan, other territories in Asia, and North America.
- Gross profit for the nine months ended September 30, 2025, was $626,000, down from $1,034,000 in the prior year period, resulting in a lower gross margin of 30% compared to 43% in 2024.
- The company reported a net loss of $10.8 million for the nine months ended September 30, 2025, which is relatively unchanged from the net loss of $10 million in the same period last year.
- There is uncertainty regarding the timeline for FDA approval of the post-market study, which could impact the rollout and adoption of ProSense.
- Sales fluctuations are expected to continue as commercial activities ramp up in the US and globally, which may lead to inconsistent financial performance in the short term.
Good morning, and thank you for standing by. (Operator Instructions)
Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Michael Polyviou. Please go ahead.
Thank you, Ella, and welcome to IceCure Medical's conference call to review the financial results as of and for the 9 months ended September 30, 2025, and provide an update on recent operational highlights. You may refer to the earnings press release that we issued earlier this morning. Participating on today's call are IceCure Medical CEO, Eyal Shamir; and the company's CFO, Ronen Tsimerman. Before we begin, I will now take a moment to read a statement of our forward-looking statements. This call and the question-and-answer session that follows it contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws.
Words such as expects, anticipates, intends, plans,
| Access to All Earning Calls and Stock Analysis | |
| 30-Year Financial on one screen | |
| All-in-one Stock Screener with unlimited filters | |
| Customizable Stock Dashboard | |
| Real Time Insider Trading Transactions | |
| 8,000+ Institutional investors’ 13F holdings | |
| Powerful Excel Add-in and Google sheets Add-on | |
| All data downloadable | |
| Quick customer support | |
| And much more... |
Trustpilot
We'd love to learn more about your experiences on GuruFocus.com and how we can improve!
Take Survey
