IceCure Medical (ICCM) Q4 2024 earnings summary

Executive summary

• Product sales in North America grew 42% year-over-year, with continued momentum in Europe, Japan, and Asia.

• ProSense cryoablation adoption is increasing, supported by 33 investigator-initiated studies and publications in 2024, mainly for breast cancer.

• Awaiting FDA de novo marketing authorization for ProSense in early-stage low-risk breast cancer, with a favorable advisory panel vote received.

• XSense, the next-generation cryoablation system, is FDA-cleared and will be launched in the U.S. in 2026, with plans for global submissions.

Financial highlights

• Product sales increased 8% to $3.19 million for 2024, up from $2.96 million in 2023, driving total revenue to $3.29 million.

• Gross profit increased 12% to $1.45 million, with gross margin rising to 44% from 40% year-over-year.

• Non-GAAP gross profit grew 32% to $1.35 million, and non-GAAP gross margin improved to 42% from 35%.

• Net loss increased 5% to $15.32 million ($0.30 per share) for 2024, compared to $14.65 million ($0.32 per share) in 2023.

• Cash and cash equivalents were $7.6 million at year-end 2024 and $6 million as of March 24, 2025.

Outlook and guidance

• U.S. sales and distribution team is prepared to scale upon FDA approval of ProSense.

• FDA marketing authorization decision for ProSense in early-stage low-risk breast cancer is expected in 2025.

• Terumo Corporation plans to submit for regulatory approval of ProSense for breast cancer in Japan in the second half of 2025.

• XSense soft launch in the U.S. planned for 2026, with global regulatory submissions to follow.

• Additional third-party data on ProSense expected in 2025, with further regulatory milestones anticipated in China, Japan, and Israel.