29-05-2025
Icecure Medical Ltd (ICCM) Q1 2025 Earnings Call Highlights: Strategic Advances and Market ...
Release Date: May 28, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Icecure Medical Ltd (NASDAQ:ICCM) has submitted a postmarket study plan to the FDA, which is a significant milestone towards obtaining marketing authorization for their cryoablation technology.
The company experienced growth in sales in North America and Europe, with an 11% increase in North America and a 60% increase in Europe year-over-year.
Icecure Medical Ltd (NASDAQ:ICCM) has strong support from its largest shareholder, who provided a $2 million unsecured loan, demonstrating confidence in the company's technology and business plan.
The company is optimistic about potential FDA marketing authorization, which would allow them to commence commercial sales and access reimbursement under the CPT code.
There is a high level of interest from breast surgeons and interventional radiologists in participating in the planned post-market study, indicating strong market interest in the technology.
Revenue for the first quarter of 2025 was $725,000, a slight decrease from $743,000 in the same period in 2024.
Gross profit and gross margin both declined, with gross profit at $218,000 compared to $269,000 the previous year, and gross margin dropping from 36% to 30%.
Sales in Asia declined significantly, with a 60% decrease in Japan and a 40% decrease in other parts of Asia.
The company reported a net loss of $3.59 million for the quarter, slightly less than the $3.61 million loss in the previous year.
The FDA has not provided a specific timeline for the review of the postmarket study plan, creating uncertainty around the timing of potential marketing authorization.
Warning! GuruFocus has detected 4 Warning Signs with ICCM.
Q: Is the postmarket study still expected to involve a minimum of 400 patients over 25 sites, and when might the FDA respond to the submission? A: Yes, the postmarket study will require 400 patients across at least 25 sites. The FDA's top management will continue to review it, but no specific timeline for their response can be guaranteed. The package submitted was extensive, and ongoing discussions with the FDA are expected. - CEO
Q: How long is the postmarket study expected to take once approved? A: The recruitment for the postmarket study is expected to be completed within three years, with 400 patients recruited during this period. - CEO
Q: Can you provide more details on the potential for expanded reimbursement? A: With more records and claims on our specific CPT code for breast cancer, we believe we can increase reimbursement. After FDA marketing authorization, we plan to apply to the AMA to move from CPT 3 to CPT 1, which includes efficiency. Preparations for this process are underway. - CEO
Q: What is the market opportunity for the ProSense system in Japan? A: Japan has over 100,000 new breast cancer cases annually, with nearly two-thirds being low-risk, early-stage cases. The market opportunity is significant, and we expect fewer limitations compared to the US market. - CEO
Q: Can you provide a geographic breakdown of revenue growth this quarter? A: In North America, revenue increased by about 11% year-over-year, and in Europe, it increased by about 60%. In Asia, there was a decline, with Japan seeing a 60% decrease, but these numbers fluctuate due to the small base. - CFO
Q: Are there any new tariffs affecting the ProSense system in the US market? A: Yes, there were initial tariffs imposed by the US administration, but there is currently a freeze on these taxes. We will need to see future decisions by the administration. - CFO
Q: Will you expand your sales team following postmarket study approval? A: Yes, we plan to increase our sales team after receiving marketing authorization. We have a professional Vice President for North America, and we will build a team including sales reps, regional managers, and clinical application specialists. - CEO
Q: What are your commercial strategies regarding pricing and sales? A: We anticipate a 60-40 split between placements and console sales. For placements, we require a commitment to a monthly number of probes over 2-3 years at a higher price. We will also sell consoles and single-use probes separately. - CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
