IceCure Medical Ltd. (ICCM) Q2 2026 Earnings Call Transcript

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 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, intents, plans, beliefs, 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 discussed the continued 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 continued expansion of the CHOI study, the potential for clinical evidence and commercial utilization to support position confidence, reimbursement initiatives, and broader market adaptions. 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. The forward-looking statements contained or implied during this call are subject to other risk and uncertainties, many of which are beyond the control of the company, including those set forth in the risk factor section of the company's annual report on Form 20F 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 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, August 12, 2026. I will now turn the call over to Ice Cube Medical 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 Ice Cube. Over the past several years, we have focused on building the clinical regulatory and scientific foundation for persons. 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 in generating additional real-world clinical experience, that expanding both of evidence, transition confidence, support, future reimbursement initiatives, and encourage border adoption. As more physicians adopt process, 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 a growth of both process 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 process suggest that physicians are incorporating process into routine clinical practice and treating more patients over time this requiring utilization give us confidence that commercial adoptions 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 install base. At the same time, we are training our commercial organizations through additional sales hire 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 tree marketing clinical study, the choice trial in the post-market study is not a separate from our commercialization strategy. Rather, it is an extension of it. Participating clinical sites purchase disposable probe is part of the routine patient care while simultaneously contributing value real-world clinical evidence. Some participating physicians have already transitioned from clinical investigators into active commercial users of process while additional leading institutions are joining the study and becoming a new user of our technology. This means that clinical evidence generating is supporting commercial adoption while commercial utilization is signaling expanding 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 CHOI study. We remain on track to execute against our planned objectives and look forward to providing additional updates 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 CHOI study, we continued the scientific foundation supporting process. During the first half of 2026, we reported positive five-year results from our high-secret kidney cancer study and presented the final data at the ECIO 2026. We also continue important recognition from the medical community through inclusion of persons in the American Society of West Surgeons Resource Guide, new peer-reviewed publications in the International Journal of Surgery and PLOS One, and the Society of Interventional oncologist petition requesting the inclusion of cryoablation in the national comprehensive cancer network breast cancer guideline, 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 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 finance 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 extensions, physician engagement, clinical evidence generating, and reimbursement initiative 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 disposables for utilization, continued clinical recognition, advance of the choice trial, and assuming financial position. Individually, each of this achievement is important. Together, they tell a much bigger story. They demonstrate that ISQ 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, Mayor Penel, 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 process systems and disposal props, reflecting continued commercial expansion and increasing utilization across our commercial install base. Gross profit increased to $548,000 during the first half of 2016 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 after the impact of foreign exchange fluctuation during the period, which partially offered 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 process 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 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 on our commercial install 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 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 cost 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 shareholders' value. With that, operator, we are now ready to open the line for questions.

Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press star 1. If you wish to cancel your request, please press star 2. If you are using speaker equipment, kindly leave the answer before pressing the number. Your questions will be pulled in the order they received. Please stand by while we pull for your questions. This is from Camp Doliver of Brooklyn Capital Markets. Please go ahead.

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?

Mayor, please. Hi, Kemp. This is Ayal.

Mayor, if you could please handle this question. yeah sure um so for your question most of our revenue come from new purchases of systems rather than uh at least least uh this is which we do uh has that mix changed year over year that's uh that's really what i'm asking but can do uh let me just uh be fully clear You asked if the purchase system, especially in the U.S., increase year-over-year to compare with the placement.

This is your question?

Well, yeah, that's another way to think about the question, sure.

Yeah. So firstly, the percentage of the disposable remain the same with a little bit of increase year over year for the utilization of our single-use probe. We could see more utilization, but basically it remained the same with the sun 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 to the study will be a commercial site we could see more consoles that have been purchased then we just do a placement with a special a prob a special price higher price which we see very encouraged that the sites are willing to buy the console and and they put it as a new treatment and new technology as part of the coming commercialization offering a new treatment and will participate in the study as well so we could see a growth in both sides yeah

maybe maybe let me add some more color so compared to same period last year as percentage where we saw about 20 25 percent more systems this in 26 first half compared to h1 225 while the placement number is the same so So percentage-wise, the placement, or at least as you call it, is less in percentage than sales this year compared to last year.

Okay, great. And what's your installed base in the U.S. now?

Again, as we developed a 70% increase on our active, it went up. It's about the active sites, it's close to 30 in the U.S.

That was 33-0? No, no. It's about 33-0 sites altogether.

Okay. Thank you. Thank you. I'm all set.

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

Yes, thanks. So, I just want to clarify. So, the commercial footprint grew 70%. So, what is the active commercial install base? Did you just give that number? I wasn't clear.

No, we just mentioned, if you remember, during June, that since the FDA on October last year, we grew by 70% on the active sites. Okay, and that number as of June 30th or as of today on active commercial sites is how many? it is above 30 because we have some sites we have some sites that they will not participate they just will continue to do a commercial use only like we 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 do not be part of the PMS about part of the clinical so and and the number of clinical sites as of now or June 30th is how many we you know we we have in process and 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 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.

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.

Yeah, exactly, exactly, Anthony.

Okay, perfect. And then on the gross margin this quarter, so it was a little bit lower than expectation. Was that, is there some maybe one-time charges in there, or is it just a sales mix between the probes and the system sales?

So it's a combination of two things. As you mentioned, there is a mix change, but I would say it's a minor one. The main reason for not having a much higher gross margin, as expected, because of the higher top line is mainly because of exchange rate fluctuations, okay? If we were using the same exchange rate, I'm talking about shekel and U.S. dollar, one, as last year, the gross margin were much higher, two digits, than today.

Okay, yeah, no, we actually spoke with an Israeli company yesterday, and they said the same thing. There was the FX impact from shekels versus dollars this quarter that impacted them as well. Okay, so in terms of getting these other, so you have two actives that have gone through the process. The IRB approval, I know that can be somewhat problematic in terms of timing, but how long does it take approximately for each hospital to get that approval? Does it take at least a month? Could it take more than three months? I know it's a little bit of a painful process, but just trying to understand the timing of it.

Yes, Shai, the COO, will answer that.

Yes, thank you, Rial. Hi, Anthony. Some sites are using a central IRB, which is a much simpler process that could take three to four or to five weeks, and some are using their own IRB, which could be a little bit longer, four to six to seven weeks. This is approximately the time frame for an IRB.

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

Yeah, we believe with high confidence that we will be able to meet. We need to meet the first patients before September 1st, 5th. This is why I mentioned that we expect the first patient enrolled, actually, even for the FDA definition, is enrolled, not even treated. And we know that the two sites, one of them is by Dr. Richard Fine, who was the president of the society, and he did 51 cases as part of the ICE region, a very well-experienced site. We visited him, you know, early this week. They are fully ready. They have some patients in the list. Same with Dr. Dennis Holmes. He is doing, you know, the highest number in the U.S. as a concierge breast surgeon. So we believe that they will do it. And all together with Dr. Natalie Johnson, who was, again, the president of the society, she will be one of the next sites, et cetera. we believe that we will be able also to meet the AP patients by March 2027.

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

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 questions. First, on the last conference call, you mentioned the CPT1 code, reimbursement code was to be filed in mid-June. Can you give us any updates on that in what the next step in that reimbursement expansion would be? Thank you.

Thank you very much, Andrew. I mean, according the AMA compliance and confidential clause that are very strict, I cannot confirm or not confirm about the submission, but I could say that we are progressing with our plan as we discussed. The AMA is not allowing to announce it. And we didn't see any other publicly credited company that announced a submission. So we need to comply, not to risk, but we are progressing with our plan.

Okay, fair enough. And hypothetically, if one was to submit the CPT-1 code, 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 our next data point?

We heard from one of your colleagues that they saw by themselves at the AMA website that it's publicly open, that they thought in the coming agenda of the AMA meeting which expected to be second or third weekend of September that the breast cancer cryoablation is part of the agenda. This is open for everyone to see. Again, we cannot announce it.

Okay, great. Thank you for that color. And then when we think about revenues, it looks like the first quarter and the second quarter were both a higher elevated level of 900,000 plus or minus. How should we think about the second half of 26?

Would you expect an inflection in the fourth quarter, or should we, you know, steady progress in the third, or just trying to get a sense of how we should think about the trajectory, given everything, including seasonality in anything else that may impact it thank you yeah you want me to yes yes please man go ahead yeah so of course we were not getting forward looking projection here but you can you can take into consideration that normally Q3 this analogy is the lower compared to other words because of vacations everywhere in the world, or at least at the north side of the equator. And Q4 is traditionally our strongest quarter in the year. So with that and with the growth we showed in H1, you can project more or less how much we will do in H2.

Okay, great. Thank you for that, caller. A final question, a little bit more of a specific question. When we think about shares outstanding, should we expect – I went through some of the filings that came out today, but haven't went through them fully, but it looks like a lot of pre-funded warrants came through, about $1.2 million. Should we expect that to be additive to shares outstanding for Q3?

Please repeat if we should expect the reminder of the pre-funded warrants. That's a question.

If the accounting for the pre-funded warrants, it looks like a bunch went through in July and August, would that be purely additive to shares outstanding, or is some of that already counted?

Some of them were already counted.

Okay. All right, I'll go through that separately then. Thank you for taking the question.

If there are any additional questions, please press star 1. If you wish to cancel your request, please press star 2. Please stand by where we pull for more questions. There are no further questions at this time. I will turn the call over to Arayal Shamir for concluding remote.

Thank you for joining us today and for your continued interest in Ice Cube. As we look ahead, our priorities remain very clear. First, we will continue to extend our commercial footprint by increasing physician adoptions, growing procedures volume, and further senior utilization across our install base. Second, we will continue executing the choice study, adding additional leading clinical sites, and initiating patient enrollment as we advance the study according to the 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's future reimbursement opportunity. Third, we will continue our scientific and clinical foundation supporting process through ongoing investigator-led research, peer-reviewed publication, medical societies' 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 physician 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 a way of a business is evolving. Commercial adoption is supporting clinical evidence, and clinical evidence is transforming physician confidence. Growing physician confidence is expanding commercial adoption. We believe this creates a powerful and sustainable foundation for long-term growth. We are still in an 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 ISU team, thank you for your continued support and confidence. We look forward to updating you on our continued progress throughout the remaining of the year.

This concludes the IQ First Hap 2026 Results Call to Score. Thank you for your participation. You may go ahead and disconnect.