IceCure Medical Ltd.(ICCM)Q2 2026 法說會逐字稿

Good morning, and thank you for standing by. Currently, all 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 statements about forward-looking statements. This call and the question-and-answer session that follows 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 laws. 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. 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, anticipated enrollment of the first patients in and continued 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 plan used for its financial resources and the company's ability to execute its long-term growth strategy and create sustainable long-term shareholder value.

The forward-looking statements contained or implied during this call are subject to 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 12/31/2025, filed with the SEC on 03/17/2026, which is available on the SEC's website www.sec.gov. The company disclaims any intention or obligation, except as required by law, to update or advise 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, 08/12/2026. I will now turn the call over to IceCure's CEO, Eyal Shamir. Eyal, please go ahead.

Thank you, operator, and thank you, everyone, for joining us today. 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 generating additional real-world clinical experience while expanding the body of evidence to answer physician confidence, support future reimbursement initiatives and encourage broader adoption.

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 growth of both ProSense systems and disposable products. More importantly, this growth reflects increasing physician adoption and utilization of our technology across our commercial installed base. One of the most meaningful metrics of commercial progress is not simply the number of systems placed, 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.

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 installed 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 is our FDA-approved CHOICE post-market study. I would like to emphasize an important point regarding the CHOICE study. Unlike traditional pre-market clinical studies, the CHOICE trial is a post-market study and is not separate from our commercialization strategy. Rather, it is an extension of it. Participating clinical sites purchase disposable probes as part of routine patient care while simultaneously contributing valuable real-world clinical evidence.

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 new users of our technology. This means that clinical evidence generation is supporting commercial adoption while commercial utilization is stimulating and expanding real-world evidence supporting ProSense. 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 updates as the CHOICE study continues to expand. We believe that the growing body of real-world evidence generated from the CHOICE study, together with increasing commercial adoption, will continue supporting physician confidence, future reimbursement initiatives and broader market adoption over time.

Beyond the CHOICE study, we continue strengthening the scientific foundation supporting ProSense. During the first half of 2026, we reported positive five-year results from our ICE3 kidney cancer study and presented the final data at the ECIO 2026. We also continue to receive 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 (NCCN). Outside of the United States, 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 the regulatory process takes time, we remain encouraged by the growing level of clinical interest and engagement we continue to see. 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 generation and reimbursement initiatives as we execute our long-term growth strategy. When we step back and look at the first half of 2026, I do not 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. 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 detail.

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, reflecting continued commercial expansion and increasing utilization across our commercial installed base. Gross profit increased to $548 thousand during the first half of 2026 compared to $349 thousand 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 manufacturing and operating cost base as revenue increased. This margin expansion would have been even stronger absent the impact of foreign exchange fluctuation during the period, which partially offset the underlying operational improvement.

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 $2.0 million in the first half of 2025. 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 of our commercial installed base.

General and administrative expenses were $2.4 million in the first half of 2026 compared to $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 $8.8 million or $3.17 per share compared to $7.0 million or $3.59 per share during the first half of 2025. We ended the first half of 2026 with approximately $12 million in cash and cash equivalents compared to €8.9 million at year-end 2025, reflecting the financing activities completed during the first half including approximately $8.5 million in gross proceeds raised during the second quarter. As always, we remain focused on disciplined capital allocation while supporting the commercial, clinical and regulatory initiatives that we believe will drive long-term shareholder value. With that, operator, we are now ready to open the line for questions.

Ladies and gentlemen, at this time we will begin the question-and-answer session. If you wish to cancel your request, please press 2. If you are using speaker equipment, kindly lift your handset before pressing the number. Your questions will be posed in the order they are received. The first question is from Kemp Dolliver of Brooklyn Capital Markets. Please go ahead.

Hi. Good day, everybody. I'll ask two or three questions and go back in the queue. First of all, when I look at the growth in systems revenue year over year, how comparable is that revenue in the context of the mix of purchases versus leases, since that could impact how the numbers flow through the income statement?

This is Eyal. Meir, if you could please handle this question?

Sure. So, to answer your question, most of our revenue comes from new purchases of systems rather than leases. We do have some placements/leases, but the majority are outright system sales.

Has that mix changed year over year? That's really what I am asking.

Let me be fully clear. You're asking whether purchases of systems, especially in the U.S., increased year over year compared to placements. The short answer is yes. The percentage of disposable utilization has increased slightly year over year, reflecting more frequent use of our single-use probe. We expect utilization to continue to grow, particularly around post-market study activities, because any site that participates in the study will also be a commercial site. We are seeing more consoles being purchased rather than just placed at a special price, which we find very encouraging — sites are willing to buy the console and adopt it as a new treatment option while participating in the study. So we've seen growth on both sides: system purchases and disposable utilization.

Maybe let me add some more color. Compared to the same period last year, as a percentage we sold about 20% to 25% more systems in H1 2026 compared to H1 2025, while the number of placements is about the same. So percentage-wise, the replacement or lease component is smaller relative to outright sales this year compared to last year.

Okay. Great. And what is your installed base in the U.S. now?

We saw a 70% increase in our active U.S. sites since FDA clearance last October. The number of active U.S. sites is above 30 sites in total.

Thank you. I am all set.

The next question is from Anthony Vendetti of Maxim Group. Please go ahead.

Yes, thanks. So I just want to clarify: the commercial footprint grew 70%. What is the active commercial installed base?

Did you mean are we providing that exact number? I mentioned the 70% increase. Meir, do you want to add?

Okay. And that number as of June 30 or as of today on active commercial sites is how many?

It is above 30 active commercial sites. We have some sites that will not participate in the post-market study; they will continue to use the system commercially only. We also have other sites that are active users and continue to perform a high number of cases but are not part of the post-market clinical study.

So the number of clinical sites as of now or June 30 is how many?

We have more than 10 sites in process for the CHOICE study. We announced two sites that have signed contracts and received IRB approval. On a weekly basis, we have more sites in various stages of approving the budget, contract and IRB. The first two sites are ready and the third will come extremely soon. We expect the first patients in the next three to four weeks.

Okay. So you have more than 10 that you have identified and are working with, but you have two that have gone through the whole process — IRB approval and signed a contract — and you are expecting to enroll the first patient in the next three or four weeks. Is that correct?

Yes, exactly.

And then on the gross margin this quarter, it is a little bit lower than expectation. Were there any one-time charges in there? Or was it just a sales mix between the probes and the system sales?

It's a combination of two things. The mix change is a minor factor, but the main reason for the gross margin being lower than expected despite the higher top line was foreign exchange rate fluctuation — primarily shekel versus U.S. dollar. If we had used the same exchange rate as last year, the gross margin would have been much higher. So FX was the primary driver.

No, we actually spoke with an Israeli company yesterday; they said the same thing — there was an FX impact from shekels versus dollars this quarter that impacted them as well. In terms of IRB approval timing, how long does it take approximately for each hospital to get that approval? Does it take at least a month or more than three months? I know it is a bit of a painful process, but just trying to understand the timing.

Shay, our COO, will answer that.

Yes, thank you, Eyal. Hi, Anthony. Some sites use a central IRB, which is a much simpler process that could take three to five weeks. Some institutions use their own IRB, which could take a bit longer — approximately four to seven weeks. That's a reasonable timeframe to expect.

Okay. In terms of the post-market study, based on where you are today, do you remain confident that you will be able to hit the hurdle rates necessary in terms of patients treated as outlined by the FDA?

Yes, we are highly confident we will be able to meet those requirements. We need to meet the first patient enrollment before September 1st. For the FDA definition, enrollment is the key milestone — not necessarily treatment. We have two ready sites: one led by Dr. Richard Fine, who was a president of the society and performed 51 cases as part of ICE3, and another led by Dr. Danny Holmes, who performs a high number of cases in the U.S. They are both fully ready and have patients on their lists. In addition, Dr. Natalie Johnson, another society president, will be among the next sites. We believe we will be able to meet the enrollment milestone and reach the 80-patient target by March 2027.

Okay, great. Thanks for all that color. I appreciate it. I'll hop back in the queue.

The next question is from Scott Henry of AGP. Please go ahead.

Thank you, and good morning or afternoon depending on your location. A couple of questions. On the last conference call you mentioned a CPT code reimbursement submission was to be filed in mid-June. Can you give us any updates on that and what the next step in that reimbursement expansion would be?

Thank you. Regarding AMA compliance and confidentiality, they are very strict. I cannot confirm or deny whether a submission has been made. However, I can say we are progressing with our plan as discussed. The AMA does not allow us to announce specifics. That said, publicly available information shows that breast cancer cryoablation is on the agenda for the AMA meeting expected the second or third weekend of September. We cannot speak more to the specifics, but we are proceeding according to our plan.

Okay, fair enough. Hypothetically, if one was to submit a CPT code request, what would the next step be? Is there a timeline where they would ask for comment or would they publish something? When would we expect the next data point? Also, when we think about revenues, it looks like Q1 and Q2 were both at an elevated level of roughly $900k each. How should we think about the second half of 2026? Would you expect an inflection in Q4 or steady progress in Q3? Trying to get a sense of trajectory given seasonality and other factors that may impact it.

We are not providing forward-looking projections on this call, but in terms of seasonality, Q3 is traditionally lower compared to other quarters due to vacations in the northern hemisphere, and Q4 is traditionally our strongest quarter. With the growth we showed in H1, you can incorporate that seasonality into your own modeling for H2.

Thank you for that color. One final question: regarding shares outstanding, should we expect the remainder of the prefunded warrants to be additive to shares outstanding for Q3? I saw filings that came out today but haven't gone through them fully. It looks like a number of prefunded warrants came through — about $1.2 million. Would that be purely additive to shares outstanding, or have some of those already been counted?

Some of the prefunded warrants were already accounted for, and some were converted in July and August. So you'll see part of them reflected already, and some will be additive when they convert. We recommend reviewing the updated filings for the precise timing and accounting treatment.

All right. I will go through that separately then. Thank you for taking the question.

If there are any additional questions, please press 1. If you wish to cancel your request, please press 2. There are no further questions at this time. I will turn the call back over to Eyal Shamir for concluding remarks.

Thank you for joining us today and for your continued interest in IceCure. As we look ahead, our priorities remain very clear. First, we will continue to expand our commercial footprint by increasing physician adoption, growing procedure volume, and further stimulating utilization across our installed base. Second, we will continue executing the CHOICE study by adding additional leading clinical sites and initiating patient enrollment as we advance the study according to plan. Importantly, we view the CHOICE study not simply as a clinical study, but as an important component of our broader commercialization strategy — one that is designed to generate real-world evidence while supporting physician adoption and future reimbursement opportunity. Third, we will continue strengthening the scientific and clinical foundation supporting ProSense through ongoing investigator-led research, peer-reviewed publications, medical society engagement, and continuous collaboration with key opinion leaders around the world.

We also remain focused on advancing our long-term international opportunities including Japan, where we continue to see encouraging engagement from physicians, medical societies and strategic partners. When we look at the business today, we believe that the most important takeaway is not any single milestone, but the way our business is evolving. Commercial adoption is supporting clinical evidence, and clinical evidence is bolstering physician confidence. Growing physician confidence is expanding commercial adoption. We believe this creates a powerful and sustainable foundation for our long-term goals. We are still in the early stage of our commercial journey, but we are encouraged by the progress we are making and by the growing number of independent indicators validating our strategy. On behalf of the entire IceCure team, thank you for your continued support and confidence. We look forward to updating you on our continued progress throughout the remainder of the year.

This concludes the IceCure first half 2026 results conference call. Thank you for your participation. You may now disconnect.