IceCure Medical’s Earnings Call: Optimism Amid Challenges

Icecure Medical Ltd. ((ICCM)) has held its Q1 earnings call. Read on for the main highlights of the call.

IceCure Medical Ltd.’s recent earnings call painted a mixed picture of optimism and ongoing challenges. While the company celebrated positive developments with the FDA and growing interest from the medical community, it also acknowledged declining revenue and profit margins, maintaining a net loss position. Financial support from a major shareholder offers some stability as the company awaits crucial regulatory decisions.

Positive FDA Meeting Outcome

IceCure Medical reported a favorable high-level meeting with the FDA, which requested a post-market study plan. This development is seen as a positive signal for the marketing authorization of ProSense, a system designed for treating early-stage low-risk breast cancer.

Interest from Medical Community

The American Society of Breast Surgeons 2025 meeting highlighted significant interest in IceCure’s ProSense system. Many surgeons expressed eagerness to participate in the post-market study, indicating strong support from the medical community.

Strong Regional Sales Growth

Despite a slight overall revenue decline, IceCure saw impressive regional sales growth, with North America and Europe experiencing increases of 11% and 60%, respectively, year-over-year.

Financial Support from Largest Shareholder

To navigate financial uncertainties, IceCure secured a $2 million unsecured loan from its largest shareholder. This financial backing provides the company with flexibility as it awaits FDA decisions.

Overall Revenue Decline

IceCure’s total revenue decreased slightly from $743,000 in Q1 2024 to $725,000 in Q1 2025, with a notable 40% decline in Asian markets.

Decline in Gross Profit and Margin

The company experienced a decrease in gross profit from $269,000 to $218,000, and its gross margin dropped from 36% to 30% year-over-year, reflecting ongoing financial challenges.

Ongoing Net Loss

IceCure reported a net loss of $3.59 million for Q1 2025, slightly less than the $3.61 million loss in Q1 2024, indicating persistent financial hurdles.

Forward-Looking Guidance

IceCure Medical outlined its future plans, focusing on the submission of a post-market study plan to the FDA, crucial for ProSense’s marketing authorization. The study aims to recruit 400 patients across 25 sites within three years. Financially, the company plans to scale its U.S. sales team post-FDA approval and expand reimbursement opportunities.

In summary, IceCure Medical’s earnings call reflected a blend of optimism and challenges. While the company made strides with the FDA and garnered interest from the medical community, it continues to grapple with declining revenue and profit margins. Financial support from a major shareholder provides a cushion as the company navigates its path forward.