IceCure Medical Ltd (ICCM) Q2 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
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.
Key Financial Performance
Revenue $1.25 million for the 6 months ended June 30, 2025, compared to $1.75 million for the same period in 2024, a decrease due to over $200,000 in product shipments delayed because of the Israel-Iran conflict in June.
Gross Profit $349,000 for the first half of 2025 compared to $799,000 in the prior year period, with gross margin decreasing to 28% from 46% in the first half of 2024. The decline is attributed to the company's focus on building commercial scale sales.
Operating Expenses $7.39 million for the 6 months period ended June 30, 2025, compared to $7.68 million a year ago, reflecting efforts to optimize spending without sacrificing commercial or regulatory execution.
Net Loss $6.95 million or $0.12 per share for the first half of 2025 compared to $6.69 million or $0.14 per share in the same period last year, showing a slight increase in net loss.
Cash, Cash Equivalents, and Short-term Deposits $5.38 million as of June 30, 2025, which included a $2 million loan from the major shareholder, excluding the $10 million in gross proceeds raised from the rights offering closed on August 1, 2025.
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Operating Highlights
ProSense for early-stage low-risk breast cancer: Optimistic about FDA approval before year-end 2025. FDA requested a post-market study, which has been submitted. Positive adoption trends in Europe, driven by ICE3 results and independent clinical evidence.
ProSense technology: Featured prominently in major medical forums, including the American Breast Surgeons Annual Conference and the European Conference on Interventional Oncology. Data shows 91% of patients prefer ablation over surgery. Japanese data shows a 99% recurrence-free rate over 17 years for 600 patients.
European market: Increased adoption of ProSense for breast cancer cryoablation, driven by clinical evidence and ICE3 results.
Financial performance: Revenue for the first half of 2025 was $1.25 million, down from $1.75 million in 2024. Gross profit decreased to $349,000 from $799,000. Operating expenses reduced to $7.39 million from $7.68 million. Net loss was $6.95 million compared to $6.69 million in 2024.
Cash position: $5.38 million in cash and equivalents as of June 30, 2025, excluding $10 million raised from a rights offering in August 2025.
Rights offering: Raised $10 million, significantly oversubscribed, indicating shareholder confidence. Funds expected to support FDA decision and operational activities.
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Risk or Challenges
Regulatory Approval Challenges: The FDA has requested additional information and a post-market study for the ProSense device, which could delay the anticipated marketing authorization decision.
Revenue and Profit Variability: Revenue and gross profit have shown significant quarter-to-quarter variability, with a decline in revenue from $1.75 million in 2024 to $1.25 million in 2025 for the same period. Gross margin also dropped from 46% to 28%.
Geopolitical Disruptions: The Israel-Iran conflict in June caused delays in product shipments worth over $200,000, impacting revenue recognition for Q2.
Financial Sustainability: The company reported a net loss of $6.95 million for the first half of 2025, with cash reserves of $5.38 million as of June 30, 2025, excluding recent rights offering proceeds. This raises concerns about financial sustainability if FDA approval or revenue growth is delayed.
Market Adoption Risks: While there is growing adoption in Europe and Japan, the company is heavily reliant on FDA approval to accelerate its growth trajectory in the U.S., which remains uncertain.
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Guidance & Outlook
Regulatory Approval for ProSense: The company is optimistic that regulatory approval for ProSense will be granted before year-end 2025, pending satisfactory supplemental data submission to the FDA.
Post-Market Study: The FDA has requested a post-market study to be conducted after marketing authorization is granted. The plan for this study has been fully submitted to the FDA.
European Market Adoption: The company is experiencing a positive shift in adoption in Europe, particularly for breast cancer cryoablation, driven by ICE3 results and independent clinical evidence.
Clinical Data: The company expects more clinical data to be forthcoming from independent researchers, which will be leveraged to drive further adoption and utilization of ProSense.
Revenue and Gross Profit Variability: Revenue and gross profits may continue to vary quarter-to-quarter as the company focuses on building commercial scale sales.
Financial Position: The company believes its financial position, bolstered by a $10 million rights offering, is sufficient to support the anticipated FDA marketing authorization decision.
Growth Trajectory: The company believes its growth trajectory could meaningfully accelerate upon receiving the FDA's decision.
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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's the nature of the additional information that FDA requested?
A:The FDA requested information around the post-market study, including a list of potential participating sites, a qualification form for the sites, and a recruitment plan to ensure the study can be conducted successfully. The study involves 400 patients across 30 sites, with recruitment to be concluded within 3 years.
Q:Does going through this exercise lead to an increase in the budget for recruiting for the trial?
A:The budget is being updated. The final budget will depend on the full understanding of the FDA's requests, including costs for CRO, follow-up, and payments to facilities. The current CPT3 code will help cover some costs.
Q:Are you still expecting late '26 for CPT1 code from AMA, and are there changes in commercial efforts as a result?
A:Yes, late 2026 is still the target for CPT1 code approval. The company plans to start commercialization in 2026 after clearance. They have support from about 5 societies for the CPT1 application, which involves a 12-18 month process. Recruitment for commercialization will begin after clearance.
Q:Has the post-market study submission been accepted by the FDA?
A:Yes, the submission has been accepted, and the FDA is reviewing the protocol. All required information, including the intended use, IFU, and patient leaflet, has been provided. Discussions with the FDA are ongoing.
Q:What steps is IceCure taking to prepare for the potential acceptance of the post-market study and FDA approval?
A:IceCure has engaged with breast surgeons and radiologists interested in participating in the study and becoming commercial users. Some sites are preparing to purchase consoles and train users even before the study officially starts. Recruitment for new team members will begin immediately after receiving the grant letter.
Q:How are things progressing in Europe and Israel?
A:In Europe, there is growing interest in breast cancer treatments, with major conferences like CIRSE and EUSOBI focusing on breast cancer. These events are expected to drive utilization and sales. In Israel, IceCure is awaiting regulatory clearance for its next-generation access.
Q:Could you provide more details about the 7-year follow-up study in Japan?
A:The study in Japan focuses on patients aged 50 and above, with a recurrence rate of only 1%. This is attributed to Japan's standard of care, which includes whole breast radiation for all patients. The patient population and cancer type are similar to those in the U.S. and Europe, targeting low-risk, early-stage breast cancer.
Q:Is IceCure's current cash position sufficient to fund operations through FDA clearance?
A:Yes, the current cash position is sufficient to fund operations through FDA clearance. However, the final cash demands will depend on the finalized costs of the post-market study.
Q:Review of Unclear Management Responses
A:Management avoided providing specific details on the final budget for the post-market study, stating that it depends on the full understanding of the FDA's requests. Additionally, while they mentioned excitement and interest in Europe and Japan, they did not provide concrete sales projections or timelines for these regions.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
American Breast
Annual Conference
Breast Imaging
Brian Kemp
CEO Director
CEO Eyal
CFO COO
COO Brian
Cancer Society
Co Conference
Conference Interventional
European Conference
FDA marketing
Group LLC
Imaging Symposium
Interventional Oncology
LLC Research
Medical CEO
Research Division
Wainwright Co
authorization decision
cancer patient
confidence cash
evidence
follow
indicator vote
measure
patient recurrence
position
recurrence rate
researcher
right offering
vote confidence
ICCM Transcript
IceCure Medical Ltd (ICCM) Q1 2026 Earnings Call Transcript
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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
Frequently Asked Questions
Where does this earnings call transcript come from?
All transcripts are sourced directly from the official live webcast or the company’s official investor relations website. We use the exact words spoken during the call with no paraphrasing of the core discussion.
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Why do some answers appear as “Unclear” or “Inaudible”?
When audio quality is poor or multiple speakers talk over each other, we mark the section instead of guessing. This ensures complete accuracy rather than introducing potential errors.
Who creates the AI Summary and Key Q&A highlights shown above the transcript?
They are generated by a specialized financial-language model trained exclusively on 15+ years of earnings transcripts. The model extracts financial figures, guidance, and tone with 97%+ accuracy and is regularly validated against human analysts. The full raw transcript always remains available for verification.
