IceCure Medical Ltd. Q4 FY2024 earnings call

• Sales growth: 42% increase in North America sales and sales momentum in Europe, Japan, and other regions. - Research and studies: 33 investigator-initiated studies in 2024 across various cancer indications (breast, kidney, lung, etc.). - Conference participation: Participated in the SIRGALEN Breast Cancer Conference in Austria, with six abstracts on ProSense cryoablation. - FDA update: Awaiting FDA de novo marketing authorization for ProSense in early-stage low-risk breast cancer; factors contributing to longer timeline include novelty of the device, inclusion of stakeholders, and evolving FDA situation. - Advisory panel: FDA Medical Device Advisory Committee panel voted in favor of ProSense's benefit-risk profile in early-stage low-risk breast cancer. - XSEN: FDA cleared in the US, with plans to seek approval in other global jurisdictions and as next-generation platform technology.

For the twelve months ended December 31, 2024, product sales increased by 8% to $3.19 million compared to $0.96 million in the same period of 2023, driven by a 42% year-over-year sales increase in North America and growth in Europe, Japan, and other Asian territories. Total revenue, including revenue from the Terumo Corporation Agreement in Japan, was $3.29 million in 2024 compared to $3.23 million in 2023. Gross profit increased by 12% to $1.45 million in 2024, with non-GAAP gross profit rising 32% to $1.35 million. Operating expenses for 2024 were $17.15 million, a 2% increase from 2023. Net loss was $15.32 million in 2024, a 5% increase from 2023. As of December 31, 2024, cash and cash equivalents were approximately $7.6 million, and as of March 24, 2025, it was ~$6 million, with $2.6 million raised via an at-the-market offering.

• Anticipates U.S. FDA de novo marketing authorization for ProSense in early-stage low-risk breast cancer. - Terumo Corporation expected to file for regulatory approval of ProSense for breast cancer in Japan. - Seeks regulatory approval for XSEN in Israel. - Third-party data on ProSense expected to be published in medical journals and presented at conferences in 2025. - US sales team ready to support doctors and patients upon FDA decision; soft launch of XSEN in the US planned for 2026 after regulatory approvals in other markets.

• Forward-looking statements subject to risks and uncertainties, including those in IceCure Medical Ltd's Form 20-F. - Uncertainty regarding the FDA decision timeline, including evolving FDA situation and involvement of multiple stakeholders. - Competition and challenges in obtaining regulatory approvals in various global markets.

Q: Could you discuss the amount of other similar activity going on with ProSense right now as you await FDA approval and investments in the US commercial effort?

A: There are other activities, with Emory, UCLA, Mayo Clinic, and other sites in the US participating in treating breast tumors and other clinics. The US sales team has a small, focused team of four, including a VP and a sales VP with breast field experience, and plans to expand once FDA approval is received.

Q: What's the reason for the FDA taking time, and are you delaying sales hiring?

A: Delay is due to the evolving situation with the FDA and impact on different FDA teams. There is continuous discussion with the FDA, and the sales team is moving forward with the expectation of approval not being too far off, with no delay in hiring plans based on anticipation of approval.

Q: How does the transition between ProSense and XSEN play out, especially if ProSense is approved this year?

A: ProSense is the current flagship product generating sales globally. XSEN is next-generation, with a soft launch planned in the US in 2026 after regulatory approvals in other markets. ProSense will continue to generate sales in the meantime, and XSEN will gradually replace ProSense after full regulatory approvals in other regions.