Icecure Medical Ltd (ICCM) 2025 Q3 法說會逐字稿

Good morning, and thank you for standing by. (Operator Instructions)

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.

Thank you, Ella, and welcome to IceCure Medical's conference call to review the financial results as of and for the nine 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, 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 such words are intended to identify forward-looking statements. For example, we are using forward-looking statements in this presentation when we discuss that the FDA's marketing authorization process will drive meaningful growth for us and support broader access for patients; the belief that global interest following the FDA authorization will support international adoption; the belief that ProSense will be the only cryoablation system cleared in the US for blast cancer in the foreseeable future; the expectation that Terumo Corporation will submit regulatory applications for ProSense in Japan in the first half of '26; 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, 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's CEO, Eyal Shamir. Eyal, please go ahead.

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 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 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 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 adjuvant endocrine therapy, including women who are not eligible for surgery.

The indication cover a population of roughly 46,000 women in the US over 70 years of age diagnosed each year. We also 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 offer 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 that approximately 63,000 US women operated to remove the benign breast tumors via surgery treatment, which 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. We are seeing growing interest from the US clinicians, including breast surgeons, interventional radiologists, and breast radiologists, many of whom are requesting demonstration and installation. Our US commercial team is focused on expanding ProSense installation, treatment volume, and utilization.

We believe IceCure 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 five years of follow-up data, use a liquid nitrogen-based system, and use probe that are 10 guage. To our knowledge, no other company is currently conducting a breast cryoablation study in the US.

Given this significant barrier to entry, we believe ProSense will be the only cryoablation cleared in the US for breast cancer in the foreseeable future. In the US, we have over 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 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 cryoablation commercially.

We expect this rollout to drive meaningful growth in both clinical use and product adoption. ProSense currently benefits from a CPT III code covering approximately $3,800 in facility 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 US, 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 cryoablation.

The delegation, which includes five interventional radiologists and breast surgeons also observe live clinical cases in Bnai Zion and Beilinson Medical Centers in Israel. In Brazil, the largest health care 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 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 cryoablation system received regulatory approval in Israel for breast cancer and other indications. We recently secured a notice of patent allowance for XSense and its cryoprobe in the US and in Japan, further strengthen the intellectual property portfolio.

ProSense continue to gain significant visibility at leading medical conferences around the world. Since the beginning of the third quarter, it was featured at CIRSE 2025, the Japanese Breast Cancer Society Conference, the European Society of Breast Imaging Congress, and the Aptitude Health Take, the lead in the breast cancer care full summit in New Orleans.

In addition, we have partnered with Carige 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 study in breast cancer were presented and published as well as encouraging data in lung cancer and endometriosis, further demonstrating the varsatility and clinical value of ProSense. In addition to the recent approval 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 IceCure is entering an exciting growth phase. We are implementing our sales and marketing strategy in the US 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.

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 (inaudible) 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 US and globally following the FDA's marketing clearance for process in low-risk breast cancer. 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 rise quarter-to-quarter and 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. 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 2 times oversubscribed, raising $10 million in gross proceeds to support commercialization of ProSense 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 Instructions) Anthony Vendetti, Maxim.

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 in a wait-and-see mode?

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.

Okay. So there's -- 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?

Yeah, 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.

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.

Yeah. So part, Anthony, if you remember, part of our grant letter authorization letter that we got from the FDA contain like two 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 US. 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 curable, but more as the palliation treatment, according all the evidence from (inaudible) and other evidence, we believe that the number is the 88,000 new patients every year in the US for those who are non-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 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 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 US.

(Operator Instructions) There are no further questions at this time. I will turn the call over to Eyal Shamir for concluding remarks.

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 US and globally. As a great day, everyone and for those in the US. Have a happy Thanksgiving. Thank you.

This concludes the IceCure third-quarter 2025 results conference call. Thank you for your participation. You may go ahead and disconnect.