IceCure Medical Q3 2025 Earnings Call Transcript

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Provided by Quartr
November 19, 2025

Key Takeaways

  • Positive Sentiment: FDA marketing authorization granted for ProSense to treat low‑risk breast cancer (women ≥70 with tumors ≤1.5 cm), validating the company’s clinical research and positioning IceCure as a leader in minimally invasive breast cancer care.
  • Positive Sentiment: IceCure estimates an addressable U.S. market of roughly 200,000 patients annually (46k low‑risk ≥70, 88k nonsurgical, 63k benign) and expects facility CPT reimbursement to increase from ~$3,800 to just over $4,000 in January 2026, supporting commercial adoption.
  • Positive Sentiment: The company says the FDA’s requirement that any competitor submit five years of follow‑up data and use liquid nitrogen/10‑gauge probes creates a meaningful barrier to entry, likely making ProSense the only U.S.‑cleared breast cryoablation system for the foreseeable future; international momentum includes new approval in Switzerland and a planned Japan submission by Terumo in H1 2026.
  • Negative Sentiment: Financial performance shows near‑term commercial challenges: nine‑month revenue fell to $2.1M (from $2.4M), gross profit declined to $626k with margin down to 30% (vs. 43%), and net loss was $10.8M.
  • Positive Sentiment: Balance sheet improved via a $10M rights offering and ~$5.9M net ATM proceeds, leaving about $11.8M cash as of Oct 31, 2025, which management says provides runway to support regulatory, clinical, and commercial activities.
AI Generated. May Contain Errors.
Earnings Conference Call
IceCure Medical Q3 2025
00:00 / 00:00

Transcript Sections

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Operator

Good morning, and thank you for standing by. Currently, all of the participants are in listen-only mode. After management's discussion, there'll be a question-and-answer session. Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Michael Polyviou. Please go ahead.

Michael Polyviou
Michael Polyviou
Head of Investor Relations at IceCure Medical

Thank you, Ella, and welcome to IceCure Medical's conference call to review the financial results as of and for the nine months ending September 30, 2025, and provide an update on recent operational highlights. You may refer to the earnings press release that we issued earlier this morning. Participating on today's call are IceCure Medical CEO Eyal Shamir and the company's CFO Ronen Tsimerman. Before we begin, I will now take a moment to read a statement 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.

Michael Polyviou
Michael Polyviou
Head of Investor Relations at IceCure Medical

For example, we are using forwards and statements in this presentation when we discuss that the FDA marketing authorization of ProSense will drive meaningful growth for us and support broader action for patients. The belief that global interests follow the FDA authorization will support international adoption, the belief that ProSense will be the only cryoablation system cleared in the U.S. for breast cancer in the foreseeable future, the expectation that Terumo Corporation will submit a regulatory application for ProSense in Japan in the first half of 2026, the expectation that revenue and gross profits may continue to vary quarter to quarter as the company focuses on building commercial scale sales, and the belief that the company's cash, cash equivalents, and short-term deposits positions puts it in a stronger financial position to continue executing across regulatory, clinical, and commercial initiatives.

Michael Polyviou
Michael Polyviou
Head of Investor Relations at IceCure Medical

The forwards and 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 factor section of the company's annual report on Form 20F for the year ending December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025, which is available on the SEC's website at www.sec.gov. The company explains any intention or obligation accepted or required by law to update or revise any forwards and 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, November 19, 2025.

Michael Polyviou
Michael Polyviou
Head of Investor Relations at IceCure Medical

In addition, during the course of this call, we'll discuss certain metrics that are non-GAAP measures and refer you to the reconciliation tables and other information about these non-GAAP measures included in the earnings press release that we issued earlier this morning. I will now turn the call over to IceCure Medical CEO Eyal Shamir. Eyal, please go ahead.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Thanks, Michael, and hello everyone, and thank you for joining us today to review our results for the first nine months of 2025. During the third quarter, we remained focused and executed across multiple fronts, including commercial operations, technology, intellectual property, and regulatory matters. In October, we announced the most significant milestone in IceCure Medical history thus far when the FDA granted marketing authorization for our ProSense cryoablation system to treat low-risk breast cancer. This authorization validates the clinical research we have invested in over many years and positions IceCure Medical at the forefront of minimally invasive breast cancer care. As a reminder, the authorization is for women aged 70 and older with tumors up to 1.5 centimeters who are receiving adjuvant endocrine therapy, including women who are not eligible for surgery.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

The indication covers a population of roughly 46,000 women in the U.S. over 70 years of age diagnosed each year, plus an estimated 88,000 patients who are not candidates or willing to go through surgery, and patients that can be treated for palliative purposes. By addressing the needs of patients, we cannot or choose not to undergo surgery, ProSense offers an important alternative to treat cancer that was not previously available to those patients. Additionally, 10% of women are diagnosed with benign breast tumors annually, and of these, approximately 63,000 U.S. women operated to remove the benign breast tumors via a surgery treatment, which is called lumpectomy. Collectively, this is a significant addressable market for ProSense of roughly 200,000 patients annually, representing a significant opportunity ahead for IceCure. The response to the FDA decision has been extremely encouraging.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

We are seeing growing interest from the U.S. clinicians, including breast surgeons, interventional radiologists, and breast radiologists, many of whom are requesting demonstration and installation. Our U.S. commercial team is focused on expanding ProSense installation, printing volume, and utilization. We believe IceCure is well positioned at this time for reasons including the fact that the FDA marketing authorization established that any other company wishing to file for a 510(k) marketing authorization for a different cryoablation system to treat breast cancer will be required to submit five years of follow-up data, use a liquid nitrogen-based system, and use probes that are 10 gauge. To our knowledge, no other company is currently conducting a breast cryoablation study in the U.S. Given this significant barrier to entry, we believe ProSense will be the only cryoablation cleared in the U.S. for breast cancer in the foreseeable future.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

In the U.S., we have over 20 commercial sites using ProSense prior to the FDA marketing authorization. We expect the number of commercial sites will increase organically in addition to the 30 clinical sites planned for our upcoming post-market study. We have submitted the study design to the FDA for review and will provide an update when we receive the FDA approvals to move forward with the post-market study. As a reminder, the FDA approval to move—sorry, as a reminder, the clinical site while treating study patients with the benefit of reimbursement will also be available for any appropriate patients seeking ProSense cryoablations commercially. We expect this rollout to drive meaningful growth in both clinical use and product adoption. ProSense currently benefits from a CPT-3 code covering approximately $3,800 in facility cost. This is expected to increase to just over $4,000 in early January 2026.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

This improvement, combined with the FDA authorization, should support broader access for patients. Beyond the U.S., we are experiencing a high level of global interest from clinicians in response to the FDA decision in markets where ProSense is already approved for breast cancer. Just a few days ago, we added Switzerland to our growing list of countries in which ProSense has been approved. As our office in Israel, we are currently hosting a visit from a distinguished Brazilian medical delegation. Their visit encompassed a clinical overview and a roundtable discussion featuring meeting with key opinion leaders and presentation regarding ongoing clinical trial for breast cryoablation. The delegation, which includes five interventional radiologists and breast surgeons, also observed live clinical cases in Nate Sion and Bailey Medical Centers in Israel.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

In Brazil, the largest healthcare market in South America, ProSense is approved for breast cancer as well as other indications, and we have a distribution agreement with $6.6 million in sales expected over the next five years. Furthermore, our global marketing and clinical team have been approached by numerous medical societies to ensure our participation in upcoming conferences in 2026. European and Asian medical societies are specifically adding breast cancer cryoablation master classes with ProSense. On the innovation front, we continue to make strong progress. In September 2025, our next generation cryoablation system received regulatory approval in Israel for breast cancer and other indications. We recently secured a notice of patent allowance for Accent and its cryo probe in the U.S. and in Japan, further strengthening the intellectual property portfolio. ProSense continued to gain significant visibility at leading medical conferences around the world.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Since the beginning of the third quarter, it was featured at CIRSA 2025, the Japanese Breast Cancer Society Conference, the European Society of Breast Imaging Congress, and the Aptitude Health Stakeholder Leadership in the Breast Cancer Care Field Summit in New Orleans. In addition, we have partnered with Carigi Hospital in Florence, Italy, and conducted a two-day course of theoretical and hands-on training for physicians from across the globe, helping to broaden adoption and expertise for breast cancer cryoablation. Finally, an ongoing clinical validation continues to reinforce the safety and the effectiveness of our technology. During and following the end of the third quarter alone, 13 independent studies in breast cancer were presented and published, as well as encouraging data in lung cancer and endometriosis, further demonstrating the versatility and clinical value of ProSense. In addition to the recent approval in Switzerland, we are also advancing our global regulatory strategy.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Our partner in Japan, Terumo Corporation, planned to submit a regulatory application for ProSense in the treatment of breast cancer in the first half of 2026, marking an important step expanding access to ProSense in new international markets. In summary, we believe IceCure is entering an exciting growth phase. We are implementing our sales and marketing strategy in the U.S. to target a patient population of about 200,000 women annually. To drive and accelerate growth, we will continue to expand clinical evidence, improve reimbursement, and enter new markets. We are confident in the path ahead for both patients and shareholders. I will now turn the call over to Ronen.

Ronen Tsimerman
Ronen Tsimerman
CFO at IceCure Medical

Thank you, Eyal. For the nine months ended September 30, 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024. Revenue for the first nine months of 2024 included $100,000 from our exclusive distribution agreement and other services with Terumo, our distributor in Japan, while no Terumo revenue was booked during the first nine months of 2025. We had $316,000 decrease in sales during the nine months ended September 30, 2025, due to a decrease in sales in Japan, other territories in Asia, and North America, partially offset by an increase in sales in Latin America. As we have said in the past, we expect fluctuations in quarterly revenue as commercial activities ramp in the U.S. and globally following the FDA's marketing clearance for ProSense in low-risk breast cancer.

Ronen Tsimerman
Ronen Tsimerman
CFO at IceCure Medical

Gross profit for the nine months ended September 30, 2025, was $626,000 compared to $1,034,000 in the prior year period. This resulted in a gross margin of 30% versus 43% in the same period in 2024. As we previously communicated, we expect gross profit may continue to vary quarter to quarter as the company focuses on building commercial-scale sales. Overall, total operating expenses decreased to $11.5 million for the nine months ended September 30, 2025, compared to $12.2 million a year ago. This reflects our efforts to optimize spending without sacrificing commercial or regulatory execution. Net loss for the nine months ended September 30, 2025, was $10.8 million or $0.18 per share, relatively the same as net loss of $10 million or $0.22 for the same period last year.

Ronen Tsimerman
Ronen Tsimerman
CFO at IceCure Medical

As of September 30, 2025, we had $10 million in cash equivalents and short-term deposits compared to $7.6 million as of December 31, 2024. In July 2025, we completed a rights offering, which was approximately two times oversubscribed, raising $10 million in gross proceeds to support commercialization of ProSense system. During the first 10 months of 2025, we raised approximately $5.87 million in net proceeds from the sale of 5.4 million ordinary shares through an at-the-market offering facility. Bringing our cash balance as of October 31, 2025, to $11.8 million. We believe this puts us in a stronger financial position to continue executing across our regulatory, clinical, and commercial initiatives. Operator, we will now open the call for Q&A.

Operator

Thank you. We have time for a couple of questions. 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 lift the handset before pressing the numbers. Your questions will be called in the order they are received. Please stand by while we poll for your questions. The first question is from Anthony Vendetti of Maxim Group. Please go ahead.

Anthony V Vendetti
Anthony V Vendetti
Analyst at Maxim Group

Thank you, Eyal, Ronen. I just want to just find out where it's at with the FDA for approval of the post-market study. I know you're awaiting that final approval. Has there been any communication with them, or are you just kind of in a wait-and-see mode?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Hi, Anthony. Good morning. As I described in my part, we submitted the protocol to the FDA, and we started interactive communication with them in order to finalize it. But the official protocol with all other elements is already submitted to the FDA.

Anthony V Vendetti
Anthony V Vendetti
Analyst at Maxim Group

Okay. So they haven't indicated, or there's not necessarily an expected timeline of when they'll officially sign off on it. But you've identified 30 sites, and, well, there's 30 sites that you need. I believe in the last quarter, you said 20 have been identified. Can you give us an update on those numbers, please?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah. We have about 20 sites that are identified. We are adding more of that, but it's mainly around the clinical protocol, the statistical analysis plan, and the claim database. So we are working on all elements. And I believe that more or less by the end of the year, maybe the shutdown delay a bit, but by the end of the year, very early next year, we will get the final approval. And then by summer 2026, we will need to, or maybe before, but not later than summer 2026, we need to recruit the first patient, 20%, which is 80 patients by end of 2026.

Anthony V Vendetti
Anthony V Vendetti
Analyst at Maxim Group

That certainly seems like a very easy hurdle. In this press release, you mentioned that there might be even more patients that could benefit from cryoablation because the ones that are low risk, over 70, I think was originally identified as around 46,000. But in this press release, you said there's 88,000 additional patients that could benefit, as well as another 63,000 that could be treated for benign tumors as well. Is that new information? And maybe just elaborate on that, please. Thanks.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah. So part, Anthony, if you remember, part of our grant letter authorization letter that we got from the FDA contained two parts. One of them is a low-risk early stage for patients who are 70 and older, up to 1.5 centimeters. This, as you mentioned, represents about 46,000 new patients every year in the U.S.. And the second part, which is due also to the breakthrough device designation that IceCure got in 2021, is patients who are not eligible for surgery. It could be patients with comorbidities that they cannot take them to the OR and put them under general, patients who are not willing to do surgeries, patients that maybe even they are in a stage that it's less curable, but more as a palliation treatment.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

According to all the evidence from CIRSE and other evidence, we believe that the number is 88,000 new patients every year in the U.S. for those who are nonsurgical or not willing to do. And the benign breast tumors that now our new users. That the most drive is, of course, breast cancer. But those hospitals, clinic, breast surgeons, and breast radiologists seeing also younger patients, again, 1 million new patients every year, mainly from the age of 21 to 35, suffering from benign tumors, and about 63,000 of them are surgically removed. So we believe that part of this addressable market could be replaced by cryoablation as a minimally invasive because those younger patients, body image, bikini line is extremely important for them. From the outpatient facility fee, it's the same coverage, which in January will be about $4,000.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

And for that, we have a specific indication and also a specific, even CPT-1 code for benign breast tumors. So all of that giving us a potential addressable market of over 200,000 new patients every year just in the U.S..

Operator

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

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Thank you for joining our call today and for the great questions. We believe the FDA marketing authorization has dramatically changed our growth trajectory. We look forward to keeping you all updated as we continue to execute on our commercial rollout of ProSense in the U.S. and globally. Have a great day, everyone, and for those in the U.S., have a happy Thanksgiving. Thank you.

Operator

This concludes the IceCure Third Quarter 2025 Results Conference Call. Thank you for your participation. You may go ahead and disconnect.

Executives
    • Michael Polyviou
      Michael Polyviou
      Head of Investor Relations
    • Ronen Tsimerman
      Ronen Tsimerman
      CFO
    • Eyal Shamir
      Eyal Shamir
      CEO
Analysts
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