IceCure Medical Ltd (NASDAQ:ICCM) Q3 2025 Earnings Call Transcript

IceCure Medical Ltd (NASDAQ:ICCM) Q3 2025 Earnings Call Transcript November 19, 2025

IceCure Medical Ltd misses on earnings expectations. Reported EPS is $-0.06 EPS, expectations were $-0.05.

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

Michael Polyviou: Thank you, Ella, and welcome to IceCure Medical’s conference call to review the financial results as of and for the 9 months ended 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 at Eyal Shamir; and the company’s CFO, Ronen Tsimerman. Before we begin, I will now take a moment to read a statement of our 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 so forth and intended to identify forward-looking statements. For example, we are using forward-looking statements in this presentation when we discuss but the FDA’s marketing authorization process will drive meaningful growth for us and support broader access for patients. We believe the global interest following the FDA authorization will support international adoption the belief that ProSense will be the only [ cablation ] system cleared in the U.S. for blast cancer in the foreseeable future. The expectation that Terumo Corporation will submit regulatory applications for ProSense, in Japan in the first half the expectation that revenue and gross profits may continue to vary quarter-to-quarter as the company focused 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.

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, 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 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, November 19, 2025. In addition, during the course of this call, was because certain metrics that are non-GAAP measures and refer you to affiliation tables and other information about these non-GAAP measures included in the earnings press release that we issued earlier this morning.

Q&A Session

I will now turn the call over to IceCure Medical’s CEO, Eyal Shamir. Eyal, please go ahead.

Eyal Shamir: Thanks, Michael, and hello, everyone, and thank you for joining us today to review our results for the first 9 months of 2025. During the third quarter, we remained focused and executed a growth multiplying front, including commercial operations, technology, intellectual property and regulatory matters. In October, we announced the most significant milestone in IceCure history, those for when the FDA granted marketing authorization for our [indiscernible] system to treat low-risk breast cancer. This authorization validates the clinical research we have invested in over many years and positions IQ 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 or receiving aggrevant endocrine therapy, including women who are not eligible for surgery.

The indication cover a population of roughly 46,000 women in the U.S. over 70 years of age diagnosed each year. Lusan 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 choose not to undergo surgery. Persons offer an important alternative to treat cancer that was not previously available to those patients. Additionally, 10% of women are diagnosed with benign restaurants annually and of this approximately 63,000 U.S. women operated to remove the benign breast tumors VI surgery treatment, which called lumpectomy. Collectively, this is a significant addressable market for process of roughly 200,000 patients annually, representing a significant opportunity ahead for IceCure.

The response to the FDA decision has been extremely encouraging. We are seeing growing interest from the U.S. clinicians, including breast surgeons, interventional agents and breast geologists, many of whom are requesting demonstration and installation. Our U.S. commercial team is focused on expanding process installation, freezing volume and utilization. We believe IPO is the 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 different cryoablation system to treat breast cancer will be required to submit 5 years of follow-up data, use a liquid nitrogen-based system and use probe [indiscernible] engage. 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 possible future.

In the U.S., we have other 20 commercial sites using ProSense prior to the FDA marketing authorization. We expect the number of commercial site will increase organically in addition to the 30 clinical site plan 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 sticking ProSense [indiscernible] 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 [indiscernible] costs.

This is expected to increase to just over $4,000 in early January 2026. 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 encompass a clinical overview and a roundtable discussion featuring meeting with the key opinion leaders and presentations regarding ongoing clinical trial for breast [indiscernible].

The delegation, which includes 5 interventional [indiscernible] and breast [indiscernible] also observe live clinical cases in [indiscernible] and Bellingan medical centers in Israel. In Brazil, the largest health care market in Sout America, Rosen is approved for breast cancer as well as other indications. And we have a distribution agreement with EUR 6.6 million expected over the next 5 years. Furthermore, our global marketing and clinical team have been approached by numbers medical societies to ensure our participation is 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 net generation probation system received regulatory approval in Israel for breast cancer and other indications.

We recently secured a notice of patent allowance for Accent and its [indiscernible] product in the U.S. and in Japan, further strengthen the intellectual property portfolio. ProSense continue to gain significant visibility and at leading medical conferences around the world. Since the beginning of the third quarter, it was featured at [indiscernible] 2025 the Japanese Breast Cancer Society Conference, the European Society of Breast Imaging Congress and the aptitude restake the lead in the breast cancer care full summit in New Orleans. In addition, we have partnered with Karig Hospital in Florence, Italy, and conducted a 2-day course of theoretical and hands-on training for physicians from across the globe, helping to broaden adoption and expertise for breast cancer carioablation.

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 study in breast cancer world presented and published as well as encouraging data in lung cancer and endometriosis, further demonstrating the growth activity and clinical value of ProSense. In addition to the recent improvement in Switzerland, we are also advancing our global regulatory strategy with our partner in Japan, Terumo Corporation plans to submit a regulatory application for the 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 ITO 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 reinvestments 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: Thank you, Eyal. For the 9 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 9 months of 2024 included $100,000 from our exclusive distribution agreement and other services with Terumo, our distributor in Japan while [indiscernible] revenue was booked during the first 9 months of 2025. We had $316,000 decrease in sales during the 9 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 process in low-risk breast cancer.

Gross profit for the 9 months ended September 30, 2025, was $626,000 compared to $134,000 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 rise quarter-to-quarter and the company focuses on building commercial scale sales. Overall, total operating expenses decreased to $11.5 million for the 9 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 9 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.

As of September 30, 2025, we had $10 million in cash, 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 2x oversubscribed, raising $10 million in gross proceeds to support commercialization of Process Systems. During the first 10 months of 2025, we raised approximately $5.87 million in net proceeds from the sales of 5.4 million ordinary share through a 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: [Operator Instructions] The first question is from Anthony Vendetti of Maxim.

Anthony Vendetti: 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 you’re just kind of in a wait-and-see mode?

Ronen Tsimerman: 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 already submitted to the FDA.

Anthony Vendetti: Okay. So there’s — they haven’t indicated or there’s not necessarily an expected time line 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?

Ronen Tsimerman: Yes, we have about 20 sites that 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 ’26, we will need to — or maybe before, but not later than summer ’26, we need to recruit the first patient, 20% to reach 80 patients by end of 2026.

Anthony Vendetti: 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 — we originally — I think it 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.

Ronen Tsimerman: Yes. So part, Anthony, if you remember, part of our grand letter authorization letter that we got from the FDA contain like 2 parts. One of them is a low-risk early stage for patients who are 70 and older up to 1.5 centimeter. This, as you mentioned, represent 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 I still got in 2021 is patients who are not eligible for surgery. It could be patients with comorbidities that they cannot take them to the overall and put them under general patients who are not willing to do surgeries, patients that maybe even they are in stage that it’s less cable, but more as the palliation treatment, according all the evidence from sales and other evidence, we believe that the number is the 88,000 new patients every year in the U.S. for those who are surgical 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 breasts 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 the minimally invasive because those younger patients both the 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 — and for that, we have a specific indication and also a specific even CPT1 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: [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 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 poses in the U.S. and globally. As 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.