アイスキュア・メディカル（ICCM）2026年第2四半期決算説明会：上半期売上高は45%増加

主要なポイント

• ProSenseシステムおよび使い捨てプローブの売上増加に伴い、2026年上半期の売上高は前年同期比約45%増の180万ドルとなりました。
• 売上総利益は34万9,000ドルから54万8,000ドルに増加し、売上総利益率は28%から30%に改善しました。経営陣は、為替変動が利益率のさらなる拡大を抑制したと説明しています。
• IceCure Medicalの米国における商用稼働ベース（導入施設数）は、FDA承認取得後に約70%増加し、現在では30か所を超えています。
• CHoICE試験および米国での商用拡大に向けた支出が増加したことにより、純損失は前年同期の700万ドル（1株当たり3.59ドル）から880万ドル（1株当たり3.17ドル）に拡大しました。
• 第2四半期に調達した約850万ドルの資金調達総額に支えられ、上半期末時点の現金および現金同等物は約1,200万ドルに達しました。
• 経営陣は、CHoICE試験における最初の患者登録が3〜4週間以内に行われると見込んでおり、2027年3月までに80人の患者登録に到達できると考えています。

主要財務データ

事業および業績の動向

IceCureは売上高の伸びについて、機器の販売とリピート需要のある使い捨てプローブの双方によるものとしています。経営陣は、プローブの使用率の上昇は医師がより多くの患者を治療し、日常の診療にProSenseを取り入れていることを示していると強調しました。

システムによる売上高の大部分は、リースや配置（プレースメント）ではなく買い取りによるものでした。同社は2026年上半期に前年同期比で約20%〜25%多くのシステムを販売しましたが、配置数は前年並みとなりました。その結果、システム全体の構成において配置の占める割合が低下しました。

経営陣が言及したFDAの承認取得以降、米国における商用稼働ベース（導入施設数）は約70%増加し、現在では30か所を超えています。IceCureは、医師による導入および使用を後押しするため、米国の主要地域で営業人員を増員しています。

FDA承認のCHoICE市販後調査も商用化戦略の一環です。参加施設は日常の診療向けに使い捨てプローブを購入しつつ、リアルワールドエビデンスを創出します。10か所以上の施設が契約、予算交渉、または治験審査委員会（IRB）承認のさまざまな段階にありました。2施設が契約締結とIRB承認を完了しており、3番目の施設も近く完了する見込みです。

IceCureはまた、腎臓がんを対象としたICESECRET試験の良好な5年間の結果を報告し、ECIO 2026で最終データを発表しました。ProSenseは米国乳外科学会のリソースガイドに掲載されたほか、新たな研究が「International Journal of Surgery」および「PLOS ONE」に掲載されました。

日本において、同社は医師、学会、および戦略的パートナーとの連携を継続しています。経営陣は、薬事・規制プロセスには時間を要すると注意を促しました。

経営陣の見通し

IceCureは正式な売上高業績予想（ガイダンス）を開示しませんでした。経営陣によると、第3四半期の売上高はバケーションシーズンにより季節的に低くなる傾向がある一方、第4四半期は伝統的に最も好調な時期であるとのことです。

CHoICE試験に関して、経営陣は3〜4週間以内に最初の患者登録が行われると予想しており、9月5日までのFDAの規定期間要件を満たせるという確信を示しました。また、同社は2027年3月までに80人の患者を登録できると考えています。

経営陣が掲げる優先事項は、事業基盤の拡大、施術数の増加、導入施設全体での利用率強化、CHoICE試験施設の追加、および保険償還（リインバースメント）に向けた取り組みの推進です。

リスクおよび注視事項

• イスラエル・シェケルと米ドル間の為替変動が売上総利益率の改善を抑制し、主にイスラエルを拠点とする同社のコスト構造に連動する費用を増加させました。
• CHoICE試験には、施設ごとの契約、予算の合意、およびIRB（治験審査委員会）の承認が必要です。経営陣の推計によると、中央IRBによる審査には3〜5週間、各機関独自の審査には4〜7週間かかる可能性があります。
• 研究開発、販売・マーケティング、一般管理の各部門で営業費用が増加し、純損失の拡大につながりました。
• 日本での薬事承認プロセスは、臨床での関与が高まっているものの、引き続き時間を要しています。
• IceCureは、米国医師会（AMA）の守秘義務要件のため、CPTカテゴリIコード申請の状況を確認できませんでした。経営陣は、9月に予定されているAMAの会議の公開議題に乳がんの凍結アブレーションが含まれていたことに言及しました。

アナリスト質疑応答の要点

アナリストの関心は、システムの買い取りと配置（プレースメント）の比率、米国の導入施設規模、CHoICE試験の患者登録時期、保険償還の進捗、売上総利益率、および下半期の季節性に集中しました。

経営陣によると、システムの直接買い取りが配置に対してシェアを伸ばし、上半期のシステム売上高は前年同期比で約20%〜25%増加しました。米国の商用稼働ベース（導入施設数）は30か所を超えています。

CHoICE試験に関しては、10を超える施設が開始準備プロセスにあり、2施設が契約とIRB承認を完了しており、経営陣は3〜4週間以内に最初の患者登録が行われると見込んでいます。審査体制に応じて、IRB承認には通常3〜7週間かかります。

利益率について、経営陣は製品構成（売上ミックス）の影響は軽微であり、売上総利益率がより大幅に改善しなかった主な要因は為替変動であると説明しました。売上高の季節性については、予想は公表しなかったものの、第3四半期は通常やや低調で、第4四半期が伝統的に最も好調である旨を改めて説明しました。

決算説明会 文字起こし全文

決算説明会の完全なトランスクリプト

経営陣による説明

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.

質疑応答

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.