IceCure Medical Ltd (ICCM) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The company's financial performance shows declining revenue, gross profit, and margins, indicating challenges in maintaining profitability. Despite the optimism around FDA approval and market potential, the lack of a concrete timeline for regulatory approvals and the unclear management responses in the Q&A create uncertainty. The ongoing net losses and limited cash position add to financial strain. These factors, combined with supply chain and sales variability, suggest a negative market reaction, likely in the -2% to -8% range, especially given the lack of market cap information for a more precise prediction.
Key Financial Performance
Revenue $2.1 million for the 9 months ended September 30, 2025, compared to $2.4 million for the same period in 2024, a decrease of $316,000. The decrease was due to a drop in sales in Japan, other territories in Asia, and North America, partially offset by an increase in sales in Latin America.
Gross Profit $626,000 for the 9 months ended September 30, 2025, compared to $1,034,000 in the prior year period, resulting in a gross margin of 30% versus 43% in 2024. The decline was attributed to fluctuations in quarterly revenue as commercial activities ramp up in the U.S. and globally.
Operating Expenses $11.5 million for the 9 months ended September 30, 2025, compared to $12.2 million a year ago, reflecting efforts to optimize spending without sacrificing commercial or regulatory execution.
Net Loss $10.8 million or $0.18 per share for the 9 months ended September 30, 2025, relatively the same as $10 million or $0.22 per share for the same period last year.
Cash, Cash Equivalents, and Short-term Deposits $10 million as of September 30, 2025, compared to $7.6 million as of December 31, 2024. The increase was due to a rights offering in July 2025, which raised $10 million in gross proceeds, and additional net proceeds of $5.87 million from sales of ordinary shares, bringing the cash balance to $11.8 million as of October 31, 2025.
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Operating Highlights
FDA Marketing Authorization: ProSense cryoablation system received FDA marketing authorization for treating low-risk breast cancer in women aged 70 and older, addressing a significant market of approximately 200,000 patients annually in the U.S.
Global Approvals: ProSense was recently approved in Switzerland and is already approved in Brazil for breast cancer and other indications.
Next-Generation System: Regulatory approval for the next-generation cryoablation system was received in Israel for breast cancer and other indications.
U.S. Market Expansion: ProSense is gaining traction in the U.S. with over 20 commercial sites and plans to expand to 30 clinical sites for a post-market study.
International Market Expansion: ProSense is approved in Brazil with a $6.6 million distribution agreement over five years and is gaining interest in Europe and Asia, including plans for regulatory submission in Japan in 2026.
Revenue and Gross Profit: Revenue for the first 9 months of 2025 was $2.1 million, with a gross profit of $626,000 and a gross margin of 30%, down from 43% in 2024.
Operating Expenses: Operating expenses decreased to $11.5 million for the first 9 months of 2025, reflecting optimized spending.
Cash Position: Cash balance as of October 31, 2025, was $11.8 million, supported by a $10 million rights offering and $5.87 million from share sales.
Barriers to Entry: FDA marketing authorization creates significant barriers for competitors, as no other company is conducting similar breast cryoablation studies in the U.S.
Clinical Validation: 13 independent studies presented and published, reinforcing the safety and effectiveness of ProSense.
Global Marketing Initiatives: ProSense featured in leading medical conferences and training programs globally to drive adoption and expertise.
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Risk or Challenges
Revenue Fluctuations: Revenue decreased to $2.1 million for the first 9 months of 2025 compared to $2.4 million in the same period in 2024, with a notable decline in sales in Japan, other territories in Asia, and North America. This highlights potential challenges in maintaining consistent revenue streams across key markets.
Gross Profit Decline: Gross profit dropped to $626,000 in 2025 from $1,034,000 in 2024, with gross margins falling from 43% to 30%. This indicates challenges in maintaining profitability as the company scales its commercial operations.
Operating Loss: The company reported a net loss of $10.8 million for the first 9 months of 2025, similar to the $10 million loss in 2024, reflecting ongoing financial strain despite efforts to optimize spending.
Market Entry Barriers: While the FDA marketing authorization for ProSense creates a competitive advantage, the requirement for 5 years of follow-up data and specific system features for competitors may limit market competition but also poses a risk if the company fails to capitalize on this window of opportunity.
Regulatory and Clinical Execution Risks: The company is awaiting FDA approval for its post-market study design and is dependent on regulatory applications in Japan and other markets. Delays or failures in these processes could hinder market expansion and revenue growth.
Supply Chain and Sales Variability: The company expects fluctuations in quarterly revenue as it ramps up commercial activities in the U.S. and globally, indicating potential challenges in achieving stable sales growth.
Cash Position and Financial Sustainability: Although the company raised $10 million in a rights offering and $5.87 million through share sales, its cash position of $11.8 million as of October 2025 may not be sufficient for long-term sustainability given ongoing losses and expansion plans.
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Guidance & Outlook
FDA Marketing Authorization Impact: The FDA's marketing authorization for the ProSense cryoablation system is expected to drive meaningful growth and support broader access for patients. The company anticipates increased adoption and utilization of ProSense in the U.S. market.
Market Expansion: ProSense is expected to be the only cryoablation system cleared in the U.S. for breast cancer in the foreseeable future due to significant barriers to entry for competitors. The company plans to expand the number of commercial sites in the U.S. and conduct a post-market study involving 30 clinical sites.
Revenue and Gross Profit Variability: Revenue and gross profits are expected to vary quarter-to-quarter as the company focuses on building commercial scale sales.
Global Market Interest: The FDA decision has spurred global interest, with ProSense already approved in markets like Switzerland and Brazil. Terumo Corporation plans to submit a regulatory application for ProSense in Japan in the first half of 2026.
Reimbursement Improvements: ProSense currently benefits from a CPT 3 code covering approximately $3,800 in costs, which is expected to increase to just over $4,000 in early January 2026, enhancing patient access.
Strategic Growth Plans: The company aims to target a patient population of about 200,000 women annually in the U.S., expand clinical evidence, improve reimbursements, and enter new markets to drive and accelerate growth.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What is the status of the FDA approval for the post-market study?
A:The protocol has been submitted to the FDA, and interactive communication has started to finalize it. The official protocol with all elements has already been submitted.
Q:Is there an expected timeline for the FDA to sign off on the protocol?
A:There is no specific timeline, but the company expects final approval by the end of the year or very early next year, with the first patient recruitment by summer 2026 and 80 patients by the end of 2026.
Q:Can you provide an update on the number of identified sites for the study?
A:About 20 sites have been identified, and more are being added. The focus is on the clinical protocol, statistical analysis plan, and claim database.
Q:What is the updated addressable market for cryoablation, and how does it compare to previous estimates?
A:The addressable market includes 46,000 low-risk early-stage patients aged 70 and older, 88,000 non-surgical patients, and 63,000 benign tumor patients annually in the U.S., totaling over 200,000 new patients per year. This is an increase from previous estimates.
Q:What is the potential market for benign breast tumors?
A:There are about 1 million new patients annually aged 21 to 35 with benign tumors, of which 63,000 are surgically removed. Cryoablation could replace some of these surgeries as a minimally invasive option, supported by a specific CPT1 code and coverage of about $4,000 starting January.
Q:Review of Unclear Management Responses
A:Management did not provide a specific timeline for FDA approval, only stating expectations for the end of the year or early next year. Additionally, while they provided updated market estimates, the explanation for the increase in addressable market size lacked detailed supporting data.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
America ProSense
Aptitude HealthTake
Brazil health
CFO moment
Carige Hospital
Conference European
Congress Aptitude
FDA authorization
FDA marketing
Medical CEO
ProSense breast
ProSense cryoablation
Switzerland
Terumo application
access patient
application ProSense
breast tumor
cancer care
cancer cryoablation
cancer future
cancer indication
cryoablation system
delegation
front
installation
interest clinician
market ProSense
measure
number
population woman
position
property
radiologist breast
reminder
response FDA
site study
society
surgery
treatment
visit
woman breast
ICCM Transcript
IceCure Medical Ltd (ICCM) Q1 2026 Earnings Call Transcript
Positive5-12
The earnings call summary reveals a positive sentiment with strong revenue growth (25% YoY), improved gross margins, and reduced net loss. The company's strategic focus on breast cancer treatment and operational highlights indicate promising prospects. However, regulatory hurdles and competitive pressures present risks. Overall, the financial performance and strategic initiatives suggest a positive outlook for the stock price, likely to increase by 2% to 8% over the next two weeks.
IceCure Medical Ltd (ICCM) Q4 2025 Earnings Call Transcript
Positive3-17
The earnings call summary presents a positive outlook with record revenue, FDA marketing authorization, and strategic growth plans. The Q&A section highlights the company's efforts to improve reimbursement and expand into new markets, with some uncertainty in timelines. Despite challenges in scaling and market penetration, the strong financial performance and optimistic guidance suggest a positive stock price movement.
IceCure Medical Ltd (ICCM) Q3 2025 Earnings Call Transcript
Unknown11-19
The company's financial performance shows declining revenue, gross profit, and margins, indicating challenges in maintaining profitability. Despite the optimism around FDA approval and market potential, the lack of a concrete timeline for regulatory approvals and the unclear management responses in the Q&A create uncertainty. The ongoing net losses and limited cash position add to financial strain. These factors, combined with supply chain and sales variability, suggest a negative market reaction, likely in the -2% to -8% range, especially given the lack of market cap information for a more precise prediction.
IceCure Medical Ltd (ICCM) Q2 2025 Earnings Call Transcript
Unknown8-13
The earnings call reveals several concerns: declining revenue and gross margin, increased net loss, and dependency on FDA approval for U.S. market growth. The Q&A highlighted uncertainties around the post-market study budget and lack of specific sales projections for Europe and Japan. While there is interest in ProSense and potential reimbursement, the financial metrics and market adoption risks overshadow these positives, suggesting a negative sentiment.
ICCM Report
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