IceCure Medical (ICCM) 2026 年第二季法說會：上半年營收成長 45%

重點摘要

• 在 ProSense 系統與拋棄式探針銷售增加的帶動下，2026 年上半年營收年增約 45% 至 180 萬美元。
• 毛利從 34.9 萬美元增至 54.8 萬美元，毛利率則從 28% 改善至 30%。管理層表示，匯率波動限制了毛利率的進一步提升。
• 在獲得 FDA 批准後，IceCure Medical 在美國的活躍商業裝機量成長了約 70%，目前涵蓋超過 30 個據點。
• 由於公司加大對 CHoICE 研究與美國商業化擴展的支出，淨虧損從 700 萬美元（或每股 3.59 美元）擴大至 880 萬美元（或每股 3.17 美元）。
• 受第二季籌集的約 850 萬美元融資毛收益支持，上半年末的現金及現金等價物達到約 1,200 萬美元。
• 管理層預計第一批 CHoICE 研究受試患者將在 3 至 4 週內收錄，並相信公司可以在 2027 年 3 月前達到 80 名患者。

關鍵財務數據

業務與營運表現

IceCure 將營收成長歸因於設備銷售以及經常性的拋棄式探針需求。管理層強調，探針使用率上升顯示醫師正在治療更多患者，並將 ProSense 融入日常臨床實務中。

大多數系統營收來自直接購買，而非租賃或放置。公司在 2026 年上半年銷售的系統數量比去年同期增加約 20% 至 25%，而放置量維持不變。因此，放置在系統組合中所佔的比例下降。

自管理層提及的 FDA 批准以來，美國的活躍商業裝機量成長了約 70%，目前已超過 30 個據點。IceCure 正於美國關鍵區域增加銷售人員，以支持醫師採用與提升使用率。

獲 FDA 批准的 CHoICE 上市後研究也是商業化策略的一部分。參與據點在進行日常患者照護時購買拋棄式探針，同時生成真實世界證據。超過 10 個據點正處於簽約、預算談判或人體試驗委員會 (IRB) 審查的不同階段。已有兩個據點簽署合約並獲得 IRB 批准，第三個據點預計近期完成。

IceCure 還公布了其 ICESECRET 腎臟癌研究的積極五年數據，並於 ECIO 2026 發表最終數據。ProSense 被納入美國乳房外科醫師學會 (American Society of Breast Surgeons) 的資源指南中，新研究成果亦發表於《國際外科期刊》(International Journal of Surgery) 及《PLOS ONE》。

在日本，公司持續與醫師、醫學會及戰略夥伴合作。管理層提醒，監管審查流程需要時間。

管理層展望

IceCure 未提供正式的營收指引。管理層表示，由於假期因素，第三季營收通常呈現季節性偏低，而第四季傳統上是公司表現最強勁的時期。

關於 CHoICE 研究，管理層預計可在 3 至 4 週內收錄首位患者，並對在 9 月 5 日前符合相關 FDA 時間要求表達信心。公司亦相信可以在 2027 年 3 月前收錄 80 名患者。

管理層明確的優先事項包含：拓展商業版圖、增加手術量、強化既有裝機據點的使用率、增加 CHoICE 研究據點以及推進醫療保險給付計畫。

風險與關注事項

• 以色列新謝克爾與美元之間的匯率波動抑制了毛利率的提升，並增加了與公司主要位於以色列的成本結構相關之費用。
• CHoICE 研究需要據點簽約、預算協議與 IRB 批准。管理層估計中央 IRB 審查需 3 至 5 週，而各機構單獨審查可能需要 4 至 7 週。
• 研發、銷售與行銷以及管理等各項營運費用增加，導致淨虧損擴大。
• 儘管臨床參與度上升，日本的監管審查流程依然耗時。
• 由於美國醫學會 (AMA) 的保密要求，IceCure 無法確認 CPT 第一類代碼 (CPT Category I code) 申請的現狀。管理層指出，乳癌冷凍消融術已出現在預計於 9 月召開的 AMA 會議公開議程中。

分析師問答重點

分析師關注的焦點包括：系統購買與放置之間的比例、美國裝機規模、CHoICE 患者收錄時程、醫保給付進展、毛利率以及下半年的季節性影響。

管理層表示，直接購買的系統銷售比重相較放置有所提升，上半年系統銷售量年增約 20% 至 25%。美國活躍商業據點超過 30 個。

在 CHoICE 研究方面，超過 10 個據點正處於啟動流程中，兩個據點已完成簽約與 IRB 批准，管理層預計 3 至 4 週內收錄首批患者。視審查機制而定，IRB 批准通常需要 3 至 7 週。

關於毛利率，管理層指出銷售組合是次要因素，匯率則是毛利率未能更大幅度提升的主因。關於營收季節性，公司重申第三季通常較弱，而第四季傳統上最強，但未發布預測。

電話會議完整逐字稿

完整財報電話會議逐字稿

管理層陳述

Operator

Good morning, and thank you for standing by. [Operator Instructions] 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 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 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 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 plans 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 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 revise any forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, August 12, 2026.

I will now turn the call over to IceCure Medical's CEO, Eyal Shamir. Eyal, 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 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 in generating additional real-world clinical experience that expanding both of evidence strengthen 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 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 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 in our FDA-approved CHoICE post-market study. I would like to emphasize an important point regarding the CHoICE study. Unlike traditional pre-marketing clinical study, the CHoICE trial is a post-market study is not separate from our commercialization strategy, rather it is an extension of it.

Participating clinical sites purchase disposable probe as part of the routine patient care while simultaneously contributing value real-world clinical evidence. 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 users of our technology. This means that clinical evidence generating is supporting commercial adoption, while commercial utilization is [ single like in ] 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 CHoICE 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 CHoICE study, we continue strengthening the scientific foundation supporting process. During the first half of 2026, we reported positive 5-year results from the -- our ICESECRET kidney cancer study and presented the final data at the ECIO 2026.

We also continue important recognition from the medical community through inclusion of ProSense in the American Society of Breast Surgeons resource guide, new peer-reviewed publications in the International Journal of Surgery and PLOS ONE and the Society of Interventional Oncology petition requesting the inclusion of cryoablation in the National Comprehensive Cancer Network Breast Cancer Guideline, the NCCN.

Outside of the 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 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 expansions, physician engagement, clinical evidence generating and reimbursement initiatives as we execute our long-term growth strategy.

When I step back and look at the first half of 2026, I don't see a series of individual milestones. I see multiple independent indicators, all pointing in the same direction. revenue growth, expanding physician adoption, increasing disposable probe utilization, continued clinical recognition, advance of the CHoICE trial and the 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.

Meir Peleg

Thank you, Eyal. I will briefly review our financial results for the first half of 2026. Revenue for the first half of 2026 increased approximately 45% year-over-year to $1.8 million compared to $1.25 million in the same period last year. The growth was driven by higher sales of both ProSense systems and disposable probes. This growth was driven by higher sales of both ProSense systems and disposable probes, reflecting continued commercial expansion and increasing utilization across our commercial install 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 after 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 to support our long-term growth strategy.

Research and development expenses were $4.3 million in the first half of 2026 compared to $3.4 million in the first half of 2025. The increase was primarily driven by the initiation of the CHoICE study, supporting the continued clinical expansion of ProSense as well as the impact of foreign exchange fluctuations on our largely Israel-based cost structure.

Sales and marketing expenses were $2.5 million in the first half of 2026 compared to $2 million in the first half of 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 noncash 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 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

[Operator Instructions] The first question is from Kemp Dolliver from Brookline Capital Markets.

分析師問答

Brian Kemp Dolliver

I'll 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?

Eyal Shamir

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

Meir Peleg

Yes, sure. So for your question, most of our revenue comes from new purchases of systems rather than lease, which we do. Yes.

Brian Kemp Dolliver

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

Eyal Shamir

Kemp, let me just be fully clear. You asked if the purchase system, especially in the U.S. increased year-over-year to compare with the placement. This is your question?

Brian Kemp Dolliver

Well, the -- that's -- well, yes, that's another way to think about the question, sure.

Eyal Shamir

Yes. 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 remains the same with the 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 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 they are very encouraged that the sites are willing to buy the console and they put it as a new treatment and new technology as part of the coming commercialization offering and new treatment and will participate to the study as well. So we could see growth in both sides.

Meir Peleg

Yes. 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 in 2026 first half compared to H1 2025, 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.

Brian Kemp Dolliver

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

Eyal Shamir

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

Brian Kemp Dolliver

That was 30, 3-0.

Eyal Shamir

No, no. It's above 30 -- 3-0 sites altogether.

Operator

The next question is from Anthony Vendetti of Maxim Group.

Anthony Vendetti

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

Meir Peleg

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.

Anthony Vendetti

Okay. And that number as of June 30th or as of today, 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 commercial use only like we announced some of them in the last 6 months or even older excellent users, some concierge users who will continue to do a high number of cases, but they will not be part of the PMS.

Anthony Vendetti

Part of the clinical. So -- and the number of clinical sites as of now or June 30th, is how many?

Eyal Shamir

We have in process more than 10. We announced the first 2 that we have a signed contract, IRB approval. But on a weekly base, we have more sites in a different process of agreeing on the budget contract and IRB approval. But the first 2 sites, the third one 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've identified that you're working with, but you have 2 that have gone through the whole process of IRB approval and signed the contract and you're expecting to treat the first patient in the next 3 or 4 weeks. Is that correct?

Eyal Shamir

Yes. Exactly, Anthony.

Anthony Vendetti

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

Eyal Shamir

So it's a combination of 2 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. Last year, the gross margin were much higher, 2 digits than today.

Meir Peleg

Okay. Yes. And we actually spoke with an Israeli company yesterday, and they said the same thing. There was that the FX impact from shekel versus dollars this quarter that impacted them as well.

Anthony Vendetti

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? Could it take more than 3 months? I know it's a little bit of a painful process, but just trying to understand the timing of it.

Eyal Shamir

Yes. Shay, the COO, will answer this.

Shay Levav

Thank you, Eyal. Some sites are using a central IRB, which is a much simpler process that could take 3 to 4 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'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?

Eyal Shamir

Yes. 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 2 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 [ IC ], very well experienced site. We visited him early this week. They are fully ready. They have some patients in the list.

Same with Dr. Dennis Holmes. He is doing the highest number in the U.S. as a concierge breast surgeon. So we believe that they will do it. And altogether with Dr. Nathalie Johnson, who was again the President of the Society, who will be one of the next sites, et cetera. We believe that we will be able also to meet the 80 patients by March 2027.

Operator

Your next question is from Scott Henry of AGP.

Scott Henry

A couple of 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 and what the next step in that reimbursement expansion would be?

Eyal Shamir

Thank you very much, [ Andrew] (sic) [ Scott ]. 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 -- is not allowing to announce it. And we didn't see any other publicly traded company that announced a submission. So we need to comply not to risk, but we are progressing with our plan.

Scott Henry

And hypothetically, if one was to submit the CPT1 code, what would the next step be? Is there a time line where they would ask for comment? Or would they publish something? When would we expect the next data point?

Eyal Shamir

We heard from one of your colleagues that they saw by themselves at the AMA website that is publicly open that they saw in the coming agenda of the AMA meeting, which is 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.

Scott Henry

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 -- 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.

Eyal Shamir

Meir?

Meir Peleg

Eyal, do you want me to answer or you would.

Eyal Shamir

Yes, please, Meir. Go ahead.

Meir Peleg

Yes. So of course, we're not giving forward-looking projections here, but if you can take into consideration that normally Q3 seasonality is lower compared to other quarters because of vacations everywhere in the world or at least in the north side of Ecuador. 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.

Scott Henry

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 I haven't went through them fully. But it looks like we should -- a lot of prefunded warrants came through about 1.2 million. Should we expect that to be additive to shares outstanding for Q3?

Eyal Shamir

Meir?

Meir Peleg

Can you please repeat if we should expect that as a reminder of the prefunded warrants, that's the question.

Scott Henry

Yes. 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?

Meir Peleg

Some of them were already counted.

Operator

[Operator Instructions] There are no further questions at this time. I 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 procedures volume and further strengthening 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, one that is designed to generate real-world evidence, while supporting physician adoption, future reimbursement opportunity.

Third, we will continue strengthening our scientific and clinical foundation supporting process through ongoing investigator-led research, peer-reviewed publication, medical society engagement and continued 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 of the business is evolving. Commercial adoption is supporting clinical evidence and clinical evidence is strengthening physician confidence. Growing physician confidence is expanding commercial adoption. We believe this creates a powerful and sustainable foundation for our long-term growth.

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 remaining of the year.

Operator

This concludes the IceCure's First Half 2026 Results Conference Call. Thank you for your participation. You may go ahead and disconnect.