IceCure Medical Ltd. Ordinary SharesICCM
Recorded

IceCure Medical Ltd. Ordinary Shares 2026 Q2 Earnings Call

Review the key takeaways and the transcript of this earnings call.

PeriodQ2 2026Duration34 minParticipants7

Transcript

Preview the first fifteen paragraphs, organized by speaker.

Operator

Good morning, and thank you for standing by. Currently, all of the participants are in listen-only mode. After management's discussion, there will be a question-and-answer session. Please be advised that today's conference call is being recorded. Before we begin, I will now take a moment to read a statement about forward-looking statements. This call and the question-and-answer session that follows it contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities law. Words such as expects, anticipates, intends, plans, believes, seeks, estimates, and similar expressions or variations of such words are intended to identify forward-looking statements.

Operator

For example, we are using forward-looking statements in this presentation when we discuss the continuing growth and sustainability of commercial adoption and utilization of ProSense, the expansion of the company's U.S. and international commercial presence, the anticipated enrollment of the first patients in and continuing expansion of the ChoICE Study, the potential for clinical evidence and commercial utilization to support physician confidence, reimbursement initiatives, and broader market adoption, the company's commercialization efforts in Japan, the planned use for its financial resources, and the company's ability to execute its long-term growth strategy and create sustainable long-term shareholder value.

Operator

The forward-looking statements contained or implied during this call are subject to other risks and uncertainties, many of which are beyond the control of the company, including those set forth in the Risk Factors section of the company's annual report on Form 20-F for the year ended December 31, 2025, filed with the SEC on March 17, 2026, which is available on the SEC's website, www.sec.gov. The company disclaim any intention or obligation, except as required by law, to update or revise any forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, August 12, 2026. I will now turn the call over to IceCure Medical's CEO, Eyal Shamir.

Eyal ShamirCEO

Eyal, please go ahead. Thank you, operator, and thank you everyone for joining us today.

Eyal ShamirCEO

The first half of 2026 marks an important inflection point for IceCure. Over the past several years, we have focused on building the clinical, regulatory, and scientific foundation for ProSense. We invested in generating clinical evidence, achieving important regulatory milestones, and educating physicians around the world. Today, we are beginning to see those investments translate into measurable commercial momentum while continuing to generate the evidence that supports future growth. We believe what makes this stage of our evolution particularly important is that our clinical and commercial strategies are no longer progressing on separate tracks. They are increasingly reinforcing one another. Growing physician adoption is generating additional real-world clinical experience that's expanding both of evidence, strengthening physician confidence, support future reimbursement initiatives, and encourage broader adoption.

Eyal ShamirCEO

As more physicians adopt ProSense, they generate additional real-world evidence, creating a self-reinforcing cycle that we believe will continue to strengthen over time. This is exactly the transition we have been working towards. During the first half of the year, revenue increased approximately 45% year-over-year to $1.8 million, driven by the growth of both ProSense systems and disposable probes. More importantly, this growth reflects increasing physician adoption and utilization of our technology across our commercial install base. One of the most meaningful indicators of commercial progress is not simply the number of systems we place, but how frequently those systems are being used. Increasing disposable probe sales suggest that physicians are incorporating ProSense into routine clinical practice and treating more patients over time. This recurring utilization gives us confidence that commercial adoption is becoming broader, deeper, and increasingly sustainable.

Eyal ShamirCEO

Following FDA clearance for early-stage, low-risk breast cancer, we continue expanding our U.S. commercial footprint, achieving approximately 70% growth in our active U.S. commercial install base. At the same time, we are strengthening our commercial organization through additional sales hires in key U.S. regions while continuing to expand our presence across select international markets. Another important example of how our clinical and commercial strategies are coming together in our FDA-approved ChoICE post-market study. I would like to emphasize an important point regarding the ChoICE Study. Unlike traditional pre-marketing clinical study, the ChoICE trial is a post-market study, it is not separate from our commercialization strategy, rather it is an extension of it. Participating clinical sites purchase disposable probe as part of the routine patient care while simultaneously contributing value real-world clinical evidence.

Eyal ShamirCEO

Some participating physicians have already transitioned from clinical investigators into active commercial users of ProSense, while additional leading institutions are joining the study and becoming end users of our technology. This means that clinical evidence generating is supporting commercial adoption, while commercial utilization is simultaneously extending the real-world evidence-supporting process. As additional sites join, we expect to achieve another important near-term milestone with the enrollment of the first patients in the ChoICE Study. We remain on track to execute against our planned objectives and look forward to providing additional update as the ChoICE Study will continue to expand. We believe that the growing body of real-world evidence generated through the ChoICE Study, together with increasing commercial adoption, will continue supporting physician confidence, future reimbursement initiatives, and a broader market adoption over time. Beyond the ChoICE Study, we continue strengthening the scientific foundation supporting ProSense.

Eyal ShamirCEO

During the first half of 2026, we reported positive five-year results from our ICESECRET kidney cancer study and presented the final data at the ECIO 2026. We also continue important recognition from the medical community through inclusion of ProSense in the American Society of Breast Surgeons' resource guide, new peer-reviewed publications in the International Journal of Surgery and PLOS ONE, and the Society of Interventional Oncology' petition requesting the inclusion of cryoablation in the National Comprehensive Cancer Network breast cancer guideline, the NCCN. Outside of the U.S., we continue making encouraging progress across several strategic international markets. In Japan, for example, we continue to engage constructively with leading physicians, medical societies, and strategic partners as we advance our long-term commercialization efforts. While regulatory process takes time, we remain encouraged by the growing level of clinical interest and engagement we continue to see.

Eyal ShamirCEO

Finally, during the second quarter of 2026, we further strengthened our balance sheet through our recent financing, ending the first half with approximately $12 million in cash and cash equivalents. This provides us with the financial flexibility to continue investing in commercial expansion, physician engagement, clinical evidence generating, and reimbursement initiatives as we execute our long-term growth strategy. When I step back and look at the first half of 2026, I don't see a series of individual milestones. I see multiple independent indicators all pointing in the same direction. Revenue growth, expanding physician adoption, increasing disposable probe utilization, continued clinical recognition, advance of the ChoICE trial, and a strengthened financial position. Individually, each of these achievements is important. Together, they tell a much bigger story.

Eyal ShamirCEO

They demonstrate that IceCure is entering a new phase of its evolution, one in which commercial execution, clinical leadership, and financial discipline are increasingly working together to build sustainable long-term shareholder value. With that, I will turn the call over to our Chief Financial Officer, Meir Peleg, who will review our financial results in greater details.

Speaker

Thank you, Eyal. I will briefly review our financial results for the first half of 2026. Revenue for the first half of 2026 increased approximately 45% year-over-year to $1.8 million compared to $1.25 million in the same period last year. The growth was driven by higher sales of both ProSense systems and disposable probes. This growth was driven by higher sales of both ProSense systems and disposable probes, reflecting continued commercial expansion and increasing utilization across our commercial installed base. Gross profit increased to $548,000 during the first half of 2026 compared to $349,000 in the same period last year. Gross margin improved to 30% compared to 28% in the prior year period, primarily reflecting increased scale and improved operating leverage over our fixed manufacturing and operating cost base as revenue increased.

Speaker

This margin expansion would have been even stronger after the impact of foreign exchange fluctuation during the period, which partially offsets the underlying operational improvements. As we continue building commercial scale, we remain focused on balancing investment with disciplined financial management. During the first half of 2026, we continued investing in commercial expansion, clinical programs, and organizational capabilities that support our long-term growth strategy. Research and development expenses were $4.3 million in the first half of 2026 compared to $3.4 million in the first half of 2025. The increase was primarily driven by the initiation of the ChoICE Study, supporting the continued clinical expansion of ProSense, as well as the impact of foreign exchange fluctuations on our largely Israel-based cost structure. Sales and marketing expenses were $2.5 million in the first half of 2026 compared to $2 million in the first half of 2020.

Speaker

The increase primarily reflects investment in expanding our U.S. commercial organization, including additional sales personnel to support growing market activity, physician adoption, and continued expansion on our commercial install base. General and administrative expenses were ILS 2.4 million in the first half of 2026 compared to ILS 1.9 million in the first half of 2025. The increase was primarily driven by the impact of foreign exchange fluctuations on payroll-related expenses and higher non-cash share-based compensation expenses. Net loss for the first half of 2026 was ILS 8.8 million or ILS 3.17 per share compared to ILS 7 million or ILS 3.59 per share during the first half of 2025. We ended the first half of 2026 with approximately ILS 12 million in cash and cash equivalents compared to ILS 8.9 million at year-end 2025, reflecting the financing activities completed during the first half, including approximately ILS 8.5 million in gross proceeds raised during the second quarter.

Speaker

As always, we remain focused on disciplined capital allocation while supporting the commercial, clinical, and regulatory initiatives that we believe will drive long-term shareholders' value. With that, operator, we are now ready to open the line for questions.

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