IceCure Medical Ltd (NASDAQ:ICCM) Q4 2024 Earnings Call Transcript

IceCure Medical Ltd (NASDAQ:ICCM) Q4 2024 Earnings Call Transcript March 27, 2025

IceCure Medical Ltd misses on earnings expectations. Reported EPS is $-0.08 EPS, expectations were $-0.07.

Operator: Good morning and thank you for standing by. Currently, all the participants are in a 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 call over to Michael Polyviou. Please go ahead.

Michael Polyviou: Thank you, and welcome to IceCure Medical Ltd call to review the financial results as of and for the twelve months ended December 31, 2024, 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 Ltd CEO, Eyal Shamir, and company CFO and Chief Operating Officer, 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 contain 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 expected, 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 prospective U.S. FDA de novo marketing authorization for ProSense early-stage low-risk breast cancer with endocrine therapy. The belief that sales data from North America, Europe, and Japan may show that a positive marketing clearance outcome in the US may lead to higher adoption of ProSense and drive further sales momentum in global markets. The expected filing by Terumo Corporation for regulatory approval for ProSense for breast cancer in Japan. That regulatory approval for XSEN is expected in Israel and that additional third-party data on ProSense are expected to be published in medical journals and presented at prestigious medical conferences throughout 2025.

Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of IceCure Medical Ltd could differ materially from those described in or implied by the statements during this call. 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, 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, March 27, 2025.

Operator: In addition, during the course of this call, we will discuss certain metrics that are non-GAAP measures and we 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. We will now turn the call over to IceCure Medical Ltd’s CEO, Eyal Shamir. Please go ahead.

Eyal Shamir: Thank you for joining us today to review our full-year 2024 results. We are encouraged by the 42% increase in product sales in North America as well as sales momentum in Europe, Japan, and other parts of the world. We continue to see adoption of ProSense cryoablation in numerous indications across the globe, as evidenced by 33 investigator-initiated studies presented and published during 2024, the majority of which were with respect to breast cancer. Other indications included kidney, lung, bone, and soft tissue cancers. Early this month, we participated for the first time at the SIRGALEN Breast Cancer Conference in Austria. The event was mostly geared towards breast surgeons and oncologists and we received a good deal of interest at the IceCure booth.

We had six abstracts of ProSense cryoablation at the same conference, including data of I3 illustrating a growing interest in breast cancer cryoablation in the European market where the treatment already has regulatory clearance. We believe the increased sales and investigator-initiated studies demonstrate rising interest for ProSense that may gain further momentum if the FDA responds favorably to our de novo marketing authorization request for early-stage low-risk breast cancer with endocrine therapy. Additionally, we will be supporting a breast cryoablation course at the 2025 Society of Breast Imaging Conference and a preconference breast ultrasound course at the 2025 American Society of Breast Surgeons Conference next month. As we continue to await the FDA decision, we believe several factors are leading to a longer-than-expected timeline.

This includes the novelty of ProSense as a medical device that destroys breast cancer tumors. If approved, ProSense would be the first medical device for the treatment of breast cancer. Other factors include the inclusion of many important stakeholders in their decision-making process and the evolving situation at the FDA. Nevertheless, we remain engaged with the FDA and we are hopeful for a favorable decision, especially in light of the favorable recommendation from the FDA Medical Device Advisory Committee panel meeting last November. The advisory panel, which includes breast surgeons, interventional radiologists, breast oncologists, and representatives from the patients, consumer, and regulatory communities, voted in favor of the ProSense Benefit-Risk Profile in early-stage low-risk breast cancer.

We also believe the advisory panel has a public forum that delved deeply into our I3 data and evaluated ProSense’s potential impact on women. This has reached a large number of doctors and patients who have not been previously aware of our minimally invasive cryoablation treatment as an alternative to standard of care lumpectomy. We believe this public forum, as well as a growing body of investigator-initiated studies around the world, is and will generate rising interest in ProSense in the US. As a result, our US sales and distribution team is ready to support the doctors and patients upon the FDA decision. As a leader in liquid nitrogen breast cryoablation, we continue to innovate and patent new technology, including our next-generation cryoablation system, XSEN.

It is already FDA cleared in the US for the same indication that ProSense currently has, and we will seek to get it approved in other global jurisdictions. Now I will turn the call over to Ronen Tsimerman to go over the numbers.

Ronen Tsimerman: Thank you, Eyal. As Eyal mentioned earlier, growth momentum continues for ProSense and we are particularly pleased with the 42% year-over-year sales increase in North America. For the twelve months ended December 31, 2024, product sales increased by 8% to $3.19 million compared to $0.96 million for the twelve months ended December 31, 2023, driven primarily by the increase in sales in North America as well as in Europe, Japan, and other territories in Asia. Total revenue, including revenue recognition and other services from the Terumo Corporation Agreement in Japan, was up slightly to $3.29 million for the twelve months ended December 31, 2024, as compared to $3.23 million for the twelve months ended December 31, 2023, due to the increase in product sales, partially offset by a decrease in revenue recognition and other services in Japan, of $174,000 in the twelve months of 2024 and 2023, respectively.

Gross profit increased by 12% for the twelve months ended December 31, 2024, to $1.45 million from $1.3 million for the twelve months ended December 31, 2023. Gross margin increased to 44% for the twelve months ended December 31, 2024, compared to 40% in the twelve months ended December 31, 2023. Non-GAAP gross profit, which represents gross profit from sales of our products not including revenue recognition from Japan, increased by 32% to $1.35 million for the twelve months ended December 31, 2024, compared to $1.03 million for the twelve months ended December 31, 2023. Non-GAAP gross margin for the twelve months ended December 31, 2024, increased to 42% from 35% for the twelve months ended December 31, 2023. Reconciliations of these non-GAAP figures are included in the earnings press release that we issued earlier today.

Total operating expenses for the twelve months ended December 31, 2024, were $17.15 million compared to $16.89 million for the twelve months ended December 31, 2023. The slight 2% increase was due to an increase in sales and marketing expenses partially offset by a reduction in research and development and general and administrative expenses. Net loss increased slightly by 5% to $15.32 million or $0.30 per share during the twelve months ended December 31, 2024, compared to a net loss of $14.65 million or $0.32 per share for the same period last year. As of December 31, 2024, the company had cash and cash equivalents of approximately $7.6 million. As of March 24, 2025, the company has cash and cash equivalents of approximately $6 million. Between January 13, 2025, and March 24, 2025, the company raised $2.6 million in net proceeds from the sales of 2,047,277 ordinary shares under its at-the-market offering for safety.

We continue to be very diligent in our cost management while prioritizing investment in marketing and sales as well as research and development for our next-generation technologies. Our stable and growing gross profit margins on sales of products combined with increases in sales position us well as we await the FDA’s decision, which, if favorable, is expected to have a positive impact on future financial results. Operator, we will now open the call for Q&A.

Q&A Session

Operator: Thank you. Ladies and gentlemen, we will now open the call for the question and answer session. If you have a question, please press star one. The first question is from Kemp Dolliver of Brookline Capital Markets. Please go ahead.

Kemp Dolliver: Great. Thank you for taking my question. So I noticed recently that you had a ProSense cryoablation procedure done at Emory Hospital in the US. And I am curious how much other similar activity is going on right now as you await FDA approval and what investments you have made so far in the US commercial effort. Thanks.

Eyal Shamir: Yeah. Thank you, Kemp. This is Eyal. We have other activities. You know, we are not publishing some of the names if they are not allowing us to do it, but Emory started to work. We saw publication on UCLA, Mayo Clinic, and other important sites in the US participating to treat breast tumors as well as other private and mid clinics. And all of the sales that we had in 2024 were related to breast products.

Kemp Dolliver: That’s great. And yeah, how many people do you have in the US now?

Eyal Shamir: I think that, you know, we mentioned that in the past. At the moment, we have a small, very focused team. We have a VP and Mr. Shad Good, the Vice President of Sales for North America, who is bringing with him over twenty years of experience in the breast field, mainly from Johnson & Johnson Mammotome and others. And we have this one clinical support lady. The team is very focused, four of them. And as soon as we get the FDA approval, we have a plan, of course, to increase them in order to support the growth that we are planning based on the approved indication.

Kemp Dolliver: That’s great. Thank you.

Operator: The next question is from Anthony Vendetti of Maxim Group. Please go ahead.

Anthony Vendetti: Yes. Thanks. So I was just wondering if you could give a little more color. The FDA seems to be taking their time. I am wondering if that’s just because it’s such a new application. Or is there anything that you can elaborate on in terms of staffing over at the FDA or your conversations with them? And then a follow-up to that is, you know, have you delayed any sales hiring or are you still moving forward with the expectation that this is not that far off? Thank you.

Eyal Shamir: Thank you, Anthony. I think that, you know, it’s a combination that everyone heard and we saw in some of even the big players, you know, in the reports, that they are facing some delay due to the evolving situation with the FDA, which, of course, affected in some way different teams in the FDA. And due to the really important nature of this indication to the public health and to the medical community, many stakeholders of the FDA are part of it. You know? I think that one of the teams that really affected by the Trump administration’s decision and efficiency is the team that’s mainly dealing with the post-market. We have continuous discussions and we are fully engaged with the core team of the FDA. They are bringing the rest of the team in order to fast forward for a decision, and we all believe that we will get the clearance of that.

Anthony Vendetti: Okay. But in terms of timing, it’s hard to say other than, obviously, it’s not going to happen before the end of March. But in terms of, you know, how soon in, let’s say, the second quarter, is it too difficult to say at this point?

Eyal Shamir: Yeah. You know what? We cannot point to a specific date as of now, but we have continuous discussions, full engagement from our side, from their side, in order to finalize it.

Anthony Vendetti: Okay. And then just in terms of Japan, can you provide an update on the timing of your expectation for submitting a regulatory filing in Japan?

Eyal Shamir: I think that as we published and announced, the Terumo Corporation, our partner in Japan, is planning to do the submission in the second semester of this year.

Anthony Vendetti: Okay. Great. Great. Okay. I’ll hop back in the queue. Thanks so much.

Ronen Tsimerman: Thank you.

Operator: If you wish to cancel your request, please press star two. The next question is from Yi Chen of H.C. Wainwright. Please go ahead.

Eduardo: Hi. This is Eduardo on for Yi. I had a question regarding XSEN and how you kind of envision that dynamic playing out in the presence of ProSense as that gets approved in a couple of jurisdictions? Do you see it as a direct competitor? Do you see it kind of targeting different markets or users?

Eyal Shamir: Oh, yes. Yes, sir. Thank you very much. The first market, as I mentioned earlier, we got the FDA clearance on the XSEN. We are planning to do a soft launch early next year. So in the long run, this will be the product in the future, which will operate and replace the ProSense, which is our current flagship product. We are planning to do a submission in other markets and under the MDR. This is our future platform technology, which at some point will upgrade and will replace the ProSense, but we have the system in order to fulfill all the market’s needs. This is our next generation.

Eduardo: I see. I see. So I guess I’m curious. So the ProSense, if it’s approved this year, you mentioned it kind of only operating by generating revenue for 2025 and then a slow transition towards XSEN in the future.

Eyal Shamir: The ProSense is an approved product now, you know, globally. Now we are seeking in the US to get the specific indication of treating low-risk early-stage breast cancer, which, you know, we are treating breast tumors even last year or the year before. The ProSense is the flagship product that creates all the sales globally and in the US. We will start in 2026 with a soft launch in the US, and we will continue after we get all the regulatory approvals in other markets. But it will not stop any sales.

Eduardo: Understood. Thanks. That’s really helpful.

Operator: If there are any additional questions, please press star one. If you wish to cancel your request, please press star two. There are no further questions at this time. I will now turn the call back to Eyal Shamir for a concluding statement. Eyal, please go ahead.

Eyal Shamir: Thanks for participating in today’s call. We look forward to the FDA decision on marketing authorization of ProSense in early-stage breast cancer. Other potential catalysts this year include interim data from our IceCure kidney cancer study, the Terumo application for approval of ProSense in Japan for breast cancer, regulatory approval for ProSense in China, as well as more data from third-party studies of our products. Have a good day, everyone.

Operator: Thank you. This concludes the year-end results conference call. Thank you for your participation. You may go ahead and disconnect.