IceCure Medical (ICCM) Q2 2026 Earnings Call Transcript

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DATE

Wednesday, Aug. 12, 2026 at 10 a.m. ET

CALL PARTICIPANTS

• Chief Executive Officer - Eyal Shamir
• Chief Financial Officer - Meir Peleg
• Chief Operating Officer - Shay Levav

TAKEAWAYS

• Revenue -- IceCure Medical Ltd (NASDAQ:ICCM) reported $1.8 million in revenue for the first half of 2026, a 45% increase driven by higher sales of both systems and disposable probes.
• Disposable Probe Revenue -- $1.1 million, reflecting increased procedural utilization across the commercial installed base as physicians incorporated the technology into routine practice.
• System Revenue -- $757,000, growing from $529,000 in the prior year period due to new customer adoption and commercial footprint expansion.
• Gross Profit -- $548,000, increasing 57% year over year as a result of increased manufacturing scale and improved operating leverage.
• Gross Margin -- 30%, representing an improvement from 28% last year despite negative impacts from foreign exchange fluctuations.
• Net Loss -- $8.8 million, or $3.17 per share, compared to $7 million, or $3.59 per share, in the prior year period, driven by higher operating and finance expenses.
• U.S. Revenue -- $608,000 in the first half of 2026, a 64% increase following FDA clearance for the treatment of early-stage low-risk breast cancer.
• Active U.S. Installed Base -- Above 30 sites, representing 70% growth in active commercial locations since June 2026.
• Cash and Cash Equivalents -- $12 million as of June 30, 2026, compared to $8.9 million at the end of 2025.
• Q2 Financing Proceeds -- $8.5 million in gross proceeds raised during the second quarter to support commercial and clinical initiatives.
• Research and Development Expenses -- $4.3 million, up from $3.4 million primarily due to the initiation of the CHOICE post-market study and foreign exchange impacts.
• Sales and Marketing Expenses -- $2.5 million, reflecting investments in U.S. sales personnel to support growing market activity and physician adoption.
• General and Administrative Expenses -- $2.4 million, driven by foreign exchange impacts on payroll and higher non-cash share-based compensation.
• System Sales Mix -- 20% to 25% more systems were sold as a percentage of total volume in the first half of 2026 compared to H1 2025, while placement counts remained stable.
• CHOICE Study Patient Target -- 80 patients by March 2027, with management expecting the first patient enrollment within three to four weeks of the call.
• International Market Revenue -- $809,000 from territories outside the U.S., Poland, Spain, and Italy, representing a 65% increase.
• Poland Revenue -- $229,000, growing from $27,000 in the first half of 2025 due to expanded distribution and adoption.
• Shares Outstanding -- 3.4 million as of June 30, 2026, reflecting a 30-for-1 reverse share split completed in June 2024.
• Warrant Exercise Price -- $3.00 per share, representing a reduction from $16.50 for Series B and Series C warrants following shareholder approval.
• CHOICE Study Sites -- Two sites have signed contracts and received IRB approval, with more than 10 additional sites currently in the activation process.
• Net Cash Used in Operating Activities -- $8.1 million in the first half of 2026, compared to $6.9 million in the prior year period.

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RISKS

• Peleg stated that "Q3 is, you know, traditionally a lower compared to other quarters because of vacations everywhere in the world," indicating potential seasonality in quarterly results.
• Peleg noted that margin expansion "would have been even stronger after the impact of foreign exchange fluctuation during the period which partially offsets the underlying operational improvement," highlighting currency risk between the NIS and USD.
• Management stated that the company's current cash position "is not sufficient to fund its planned operations for at least the next 12 months," which "raise substantial doubts about the Company's ability to continue as a going concern."

SUMMARY

Management reported a strategic shift where clinical and commercial activities are increasingly reinforcing each other through the CHOICE post-market study. The company reported a 45% increase in revenue for the first half of 2026, supported by growth in both system sales and recurring disposable probe utilization. Management stated that the company is currently focused on expanding its U.S. commercial footprint, advancing regulatory engagement in Japan, and pursuing broader reimbursement through new CPT codes. While operating expenses increased due to clinical trial costs and foreign exchange fluctuations, a recent financing round strengthened the balance sheet to support long-term commercial goals.

• CEO Shamir characterized the CHOICE study as "an extension of" the company's commercialization strategy where sites purchase disposables while contributing clinical evidence.
• The company noted that "breast cancer cryoablation is part of the agenda" for the American Medical Association (AMA) meeting scheduled for Sept. 2026.
• CEO Shamir reported that some participating physicians "have already transitioned from clinical investigators into active commercial users of ProSense."
• Management attributed growth in disposable probe sales to physicians "incorporating ProSense into routine clinical practice and treating more patients over time."
• CEO Shamir reported that despite the fact that the "regulatory process takes time" in Japan, the company continues to see a "growing level of clinical interest and engagement" from partners.
• CFO Peleg confirmed that the company raised $8.5 million in gross proceeds during the second quarter to provide financial flexibility for clinical evidence generation and reimbursement initiatives.

INDUSTRY GLOSSARY

• ProSense: IceCure's primary cryoablation system used to treat benign and malignant tumors by freezing.
• Cryoablation: A minimally invasive process that uses extreme cold, often via liquid nitrogen, to destroy tumor tissue.
• CHOICE Study: A post-market clinical study designed to evaluate ProSense for the treatment of low-risk breast cancer in real-world settings.
• CPT Category 1 Code: A five-digit medical code used by physicians to report procedures to payers for reimbursement; Category 1 codes represent widely accepted procedures.
• IRB (Institutional Review Board): An administrative body established to protect the rights and welfare of human research subjects recruited to participate in clinical studies.
• NCCN (National Comprehensive Cancer Network): An alliance of cancer centers that develops clinical practice guidelines for oncology.
• AMA (American Medical Association): The organization responsible for maintaining and updating CPT codes used in the United States healthcare system.

Full Conference Call Transcript

Operator: Good morning, and thank you for standing by. Currently, all 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 2 thousand and other federal securities law. Words such as expects, anticipates, intends, plan, believe, 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 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 12/31/2025, filed with the SEC on 03/17/2026. Is available on the SEC's website www.sec.com. 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 iQ Medical's CEO, Eyal Shamir. Eyal, please go ahead.

Eyal Shamir: Thank you, operator, and thank you, everyone, for joining us today. The first half of 2026 marks an important inflection point for IQ. 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 physician 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 1 another.

Growing physician adoption generating additional real world clinical experience, yet expanding both 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.

1 of the most meaningful metric of commercial progress is not simply the number of systems replaced, but how frequently those systems are being used. Increasing disposable probe cells suggest that physicians are incorporating ProSense into routine clinical practice and treating more patients over time. This recurring utilization give 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 streaming our commercial organizations 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-market clinical study, the CHOICE trial is a post market study is not separate from our commercialization strategy. Rather it is an extension of it. Participating clinical sites purchase disposable probes as part of the routine patient care while similar 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 a new user of our technology.

This means that clinical evidence generation is supporting commercial adoption while commercial utilization is stimulating 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 update as the CHOICE study will continue 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 a broader market adoption over time. Beyond the CHOICE study, we continue strengthening the scientific foundation supporting ProSense.

During the first half of 26, we reported positive 5 year results from our ICE3 kidney cancer study and presented the final data at the ECIO 26. 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 1 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 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 26, 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 initiative as we execute our long term growth strategy.

When we step back and look at the first half of 26, 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 the strengthening financial position. Individually each of these achievements is important; together they tell a much bigger story. They demonstrate that IQ is entering a new phase of its evolution, 1 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.

Meir Peleg: Thank you, Eyal. I will briefly review our financial results for the first half of 26. Revenue for the first half of 26 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 thousand during the first half of 26 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 after the impact of foreign exchange fluctuation during the period which partially offsets 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 26, 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 26 compared to $3.4 million in the first half of 25.

The increase 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 26 compared to $2 million in the first half of 25. 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 our commercial installed base. General and administrative expenses were $2.4 million in the first half of 26 compared to $1.9 million in the first half of 25.

Increase was primarily driven by the impact of foreign exchange fluctuations on payroll related expenses and higher noncash share based compensation expenses. Net loss for the first half of 26 was $8.8 million or $3.17 per share compared to $7 million or $3.59 per share during the first half of 25. We ended the first half of 26 with approximately $12 million in cash and cash equivalents compared to €8.9 million year end 2025 reflecting the financing activities completed during the first half including approximately $8.5 million in gross profit 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.

Operator: 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 hand up before pressing the number. Your questions will be posed in the order they are received. The first question is from Kemp Dolliver Brooklyn Capital Markets. Please go ahead.

Kemp Dolliver: Hi. Good day, everybody. I will ask 2 or 3 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. Hi, Kemp.

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

Meir Peleg: Yeah. Sure. So your question, most of our revenue comes from new purchases. Of systems rather than lease which we do. I mean, yep.

Kemp Dolliver: Has that mix changed year over year? that is that is really what I am asking.

Eyal Shamir: Can do you let me just be fully clear. You asked if the purchase system, especially in The US, increased year over year to compare with the placement? This is the impression.

Kemp Dolliver: Well, the that is well, yeah, that is another way to think about the question.

Eyal Shamir: Sure. Yeah. So firstly, the percentage of the disposables remain the same with a little bit of increase year over year for the utilization of our single use probe. We could see a 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 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 than we just do a placement with a special probe special price, higher price, which we see it as 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 to the study as well. We could see growth in both sides. Yes.

Meir Peleg: Maybe let me add some more color. So compared to same period last year, as a percentage we sold about 20%-25% more systems this 2026, third half compared to H1 2025, while the placements number is the same. So percentage wise, the replacement or lease, as you call it, is less. In percentage than sales this year compared to last year.

Kemp Dolliver: Okay. Great. And what is your installed base in The US now?

Eyal Shamir: Again, as we as we, develop a 70% increase on our active, it went up. About the active site is close to 30 in The US, That was 33 zero? No. No. it is it is it is it is above 30, 3-0 sites, Altogether. Okay.

Kemp Dolliver: Thank you. Thank you. I am all set.

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

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

Eyal Shamir: Did you just give that number? I was not 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 site.

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

Eyal Shamir: 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 announced some of them in the last months or even older. Excellent users, some consumers users who will continue to do high number of cases, but they will not be part of the PMS. Part of the clinical.

Anthony Vendetti: So and the number of clinical sites as of now or June 30 is how many?

Eyal Shamir: We, we have in process more than 10. We announced the sales 2 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 2 sides, the third 1 will come extremely soon. And we expect the first patients in the next 3 to 4 weeks.

Anthony Vendetti: Okay. So you have more than 10 that you are that you have identified that you are working with, but you have 2 that have gone through the whole process of IRB approval and signed a contract and you are expecting to treat the first patient in the next 3 or 4 weeks. Is that correct?

Eyal Shamir: Yeah. Exactly. Exactly, Anthony. Okay, perfect.

Anthony Vendetti: And then on the gross margin this quarter, it is a little bit lower than expectation. Was that maybe there were some onetime charges in there? Or was it just a sales mix between the probes and the system sales?

Meir Peleg: it is a combination of 2 things. As you mentioned, there is a mix change but I would say it is a minor 1. The main reason for not having a much higher gross margin as expected because of the higher top line, is mainly because of exchange rates fluctuation. Okay? We were using the same exchange rate I am I am I am talking about shekel and U.S. dollar, as last year, the gross margin would have been much higher, 2 digits than today. Okay. Yes.

Anthony Vendetti: No, we actually spoke with an Israeli company yesterday, they said the same thing. There was that 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 2 active 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? Does it take more than 3 months? I know it is a little bit of a painful process, but just trying to understand the timing of it.

Eyal Shamir: Yes. Shay, the COO, will answer that.

Shay Levav: Yes. Thank you, Eyal. Hi, Anthony. Some sites are using a central IRB which is a much simpler process that could take 3 to 4 or to 5 weeks, and some are using their own IRB which could be a little bit longer 4 to 6 to 7 weeks. This is approximately the time frame for an IRB.

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

Eyal Shamir: Yes. Yes, with a high confidence that we will be able to meet. We need to meet the first patients before September 1st. 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 2 sites 1 of them is by doctor Richard Fine who was president of the society, and he did 51 cases as part of the ICE3, a very well-experienced site. We visited him, early this week. They are fully ready. They have some patients in the list. Same with doctor Danny Holmes. He is doing the highest number in The US as a concierge. Breast surgeon.

So we believe that they will do it. And altogether with doctor Natalie Johnson, who was again the president of the society, and he will be 1 of the next sites, etcetera. We believe that we will be able also to meet the 80 patients by March 2027.

Anthony Vendetti: Okay, great. Thanks for all that color. I appreciate it. I will hop back in the queue.

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

Analyst: Thank you, and good morning or afternoon, depending on your location. A couple of questions. First, on the last conference call, mentioned the CPT 1 code reimbursement code 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?

Eyal Shamir: Thank you. Thank you. Thank you very much. According to the AMA compliance and confidentiality clause, they 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 us to announce it. And we did not see any other publicly traded company that announced a submission So we need to comply. But we are progressing with our plan. Okay. Fair enough. And hypothetically, if 1 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 1 of your colleagues that they saw by themselves on the AMA website. that is publicly open, that they saw that 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 thousand plus or minus. How should we think about the second half of 2026?

Would you expect an inflection in the fourth quarter Or should we steady progress in the third? Or just trying to get a sense of how we should think about the trajectory given everything including seasonality and anything else that may impact it? Thank you. Meir, do you want me to talk to that? You want to? Yes, please, Meir, go ahead.

Meir Peleg: Yeah. So of course, we are not giving forward-looking projection here, but you can take into consideration that normally Q3 is, you know, traditionally a lower compared to other quarters because of vacations everywhere in the world or at least on 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 color. 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 have not gone through them fully. But it looks like a lot of prefunded warrants came through about $1.2 million Should we expect that to be additive to shares outstanding for Q3? Can you please repeat that? If we should expect the reminder of the prefunded warrants? that is that is correct. If the accounting for the prefunded 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.

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

Operator: 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. Will turn the call over to Eyal Shamir for concluding remarks.

Eyal Shamir: 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 adoptions growing procedure volume and further stimulating utilization across our installed 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 plan. Importantly, we view the CHOICE study not simply as a clinical study, but as an important component of our broader commercialization strategy, 1 that is designed to generate real world evidence while supporting physician adoption and future reimbursement opportunity.

Third, we will continue strengthening our scientific and clinical foundation supporting ProSense through ongoing investigator led research peer reviewed publications 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 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.

Operator: This concludes the IceCure first half 2026 results conference call. Thank you for your participation. You may go ahead and disconnect.

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