IceCure Medical (ICCM) Q4 2024 earnings summary

Executive summary

• Product sales in North America grew 42% year-over-year, with strong adoption in Europe, Japan, and Asia, driven by ProSense cryoablation technology for breast and other cancers.

• 33 investigator-initiated studies and peer-reviewed publications on ProSense were presented or published in 2024, mostly focused on breast cancer, with additional indications in kidney, lung, bone, and soft tissue.

• Awaiting FDA de novo marketing authorization for ProSense in early-stage low-risk breast cancer, with a favorable advisory panel vote received in November 2024.

• U.S. sales and distribution team is prepared to support growth upon FDA decision; XSense, the next-generation cryoablation system, is FDA-cleared for current indications.

Financial highlights

• Product sales increased 8% to $3.19 million for the year ended December 31, 2024, compared to $2.96 million in 2023.

• Total revenue rose to $3.29 million from $3.23 million year-over-year, with growth in product sales partially offset by lower revenue recognition from Japan.

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

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

• Net loss increased 5% to $15.32 million ($0.30 per share) from $14.65 million ($0.32 per share) year-over-year.

Outlook and guidance

• FDA decision on ProSense for early-stage low-risk breast cancer is pending, with expectations for a positive impact on future results if approved.

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

• Regulatory approval for ProSense in China and additional third-party data are anticipated in 2025.

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