Full Transcript: Icecure Medical Q2 2026 Earnings Call

Icecure Medical (NASDAQ: ICCM ) released second-quarter financial results and hosted an earnings call on Wednesday. Read the complete transcript below. This content is powered APIs. 8 million for the first half of 2026, driven by the growth of ProSense systems and disposable probes.

The company's gross margin improved to 30%, despite foreign exchange fluctuations, reflecting increased scale and improved operating leverage. S. commercial footprint, supported by expansions in key regions and international markets such as Japan. The Choice study, a post-market study, is progressing with expectations to enroll the first patients soon, reinforcing the company's commercialization strategy.

The company ended the first half of 2026 with approximately $12 million in cash and cash equivalents, bolstered by recent financing activities. Operational highlights include the FDA clearance for early-stage, low-risk breast cancer treatment and positive five-year results from a kidney cancer study. Management emphasized the synergistic relationship between clinical evidence and commercial adoption, aiming to build a sustainable foundation for long-term growth. Full Transcript 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 statements about forward-looking statements.

This call and the question-and-answer session that follows contain 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. S.

and international commercial presence, the 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 planned use of 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 December 31, 2025, filed with the SEC on March 17, 2026, which is available on the SEC's website, The Company disclaims 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. 20. I will now turn the call over to Icecure Medical CEO, Eyal Shamir. Eyal, please go ahead.

Eyal Shamir, CEO 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 a separate track. They are increasingly reinforcing one another, growing physician adoption and generating additional real-world clinical experience that is extending the body of evidence, strengthening physician confidence, supporting future reimbursement initiatives and encouraging 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. 8 million, driven by growth of both ProSense systems and disposable probes. More importantly, this growth reflects increasing physician adoption and utilization of our technology across our commercial installed 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 probes 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. S.

S. commercial installed base. 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-marketing 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 the 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 through 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 kidney cancer study and presented the final data at 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's petition requesting the inclusion of cryoablation in the National Comprehensive Cancer Network Breast Cancer Guidelines, the 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 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; advancement of the Choice trial; and a strengthening 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. Meir Peleg, Chief Financial Officer Thank you, Eyal.

I will briefly review our financial results for the first half of 2026. 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 $548,000 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. This margin expansion would have been even stronger absent the impact of foreign exchange fluctuations 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. 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. 5 million in the first half of 2026 compared to $2 million in the first half of 2025.

S. commercial organization, including additional sales personnel to support growing market activity, physician adoption and continued expansion of our commercial installed base. 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.

59 per share, during the first half of 2025. 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.

OPERATOR Thank you, ladies and gentlemen. At this time we will begin the question-and-answer session. If you have a question, please press star one. If you wish to cancel your request, please press star two.

If you are using a speakerphone, kindly lift the handset before pressing the numbers. Your questions will be polled in the order received. Please stand by while we poll for your questions. The first question is from Kemp Dolliver of Brookline Capital Markets.

Please go ahead. Kemp, Analyst 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.

Eyal Shamir, CEO Meir, please. Hi, Kemp, this is Eyal. Meir, if you could please handle this question. Meir Peleg, Chief Financial Officer Yeah, sure.

So for your question, most of our revenue come from purchases of systems rather than leases. Yeah. Kemp, Analyst Has that mix changed year over year? That's really what I'm asking.

Meir Peleg, Chief Financial Officer Let me just be fully clear. You asked if the purchase of systems, especially in the US, increased year over year compared with placements. This is your question. Well, that's— Well, yeah, that's another way to think about the question.

Sure. Yeah. So firstly, the percentage of the disposables remained the same with a little bit of increase over the year. For the utilization of our single-use probe, we could see more utilization, but basically it remained the same with some growth.

And we could see that especially for the coming post-market studies that will be together with the commercialization activities. Because any site that will participate in the study will be a commercial site, we could see more consoles that have been purchased than we just do a placement with a special price, higher price, which we see very encouraging that the sites are willing to buy the console and they put it as a new treatment, a new technology as part of the coming commercialization offering a new treatment and will participate in the study as well. So we could see growth in both sides. Maybe.

Maybe. Let me add some more color. So compared to the same period last year, as a percentage, we saw about 20—25% more systems this H1 ’26 compared to H1 ’20, while the placement number is the same. So percentage-wise, the placement, or lease as you call it, is less in percentage than sales this year compared to last year.

Kemp, Analyst Okay, great. And what's your installed base in the US now? Eyal Shamir, CEO Again, as we developed, a 70% increase on our active— it went up— about the active sites, it's close to 30 in the US. Kemp, Analyst That was 30?

Eyal Shamir, CEO No, no, it's above 30 sites altogether. Kemp, Analyst Okay, thank you. Thank you. I'm all set.

OPERATOR The next question is from Anthony Vendetti of Maxim Group. Please go ahead. Anthony Vendetti, Analyst at Maxim Group Yes, thanks. So I just wanted to clarify.

So the commercial footprint grew 70%. So what is the active commercial installed base? Did you just give that number? I wasn't clear.

Eyal Shamir, CEO No. We just mentioned, if you remember during June, that since the FDA in October last year, we grew by 70% on the active sites. Anthony Vendetti, Analyst at Maxim Group Okay. And that number as of June 30th or as of today on active commercial sites is how many?

Eyal Shamir, CEO It is above 30. Because we have some sites— we have some sites that will not participate; they just would continue to do commercial use only, like we announced, you know, some of them in the last six months, or even all the excellent users, some concierge users who will continue to do a high number of cases, but they will not be part of the post-market study, not part of the clinical. And the number of clinical sites as of now or June 30th is— how many? We, you know, we have in process, you know, more than 10.

We announced the first two that we have a signed contract, IRB approval, but on a weekly basis we have, you know, more sites in a different process of agreeing on the budget, contract, and IRB approval. But the first two sites— the third one will come extremely soon and we expect the first patients in the next three to four weeks. Anthony Vendetti, Analyst at Maxim Group Okay, so you have more than 10 that you've identified that you're working with, but you have two that have gone through the whole process of IRB approval and signed a contract, and you're expecting to treat the first patient in the next three or four weeks, is that correct? Eyal Shamir, CEO Yeah, exactly.

Exactly. Anthony. Anthony Vendetti, Analyst at Maxim Group Okay, perfect. And then on the gross margin this quarter, so it was a little bit lower than expectation— was that, were there some maybe one-time charges in there, or was it just a sales mix between the probes and the system sales?