IceCure Medical Q4 2024 Earnings Call Transcript

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March 27, 2025

Key Takeaways

  • Icicle Medical achieved a 42% year-over-year increase in North American product sales, driving an 8% rise in total product revenue and a 12% boost in gross profit for FY 2024.
  • The FDA de novo marketing authorization for ProSense in early-stage low-risk breast cancer is taking longer than expected due to the device’s novelty and extensive stakeholder review, despite a favorable advisory panel recommendation.
  • The company ended 2024 with $7.7 million in cash and raised an additional $2.6 million through its ATM program, while emphasizing disciplined cost management and targeted investments in sales and R&D.
  • Icicle Medical’s next-generation cryoablation system, XSENCE, has FDA clearance and is positioned as a future platform to eventually replace ProSense, with plans to seek authorization in other global markets.
  • Key upcoming catalysts include interim data from the iSECURE kidney cancer study, regulatory filings by Terumo in Japan, expected approvals in China, and publication of additional third-party ProSense studies.
AI Generated. May Contain Errors.
Earnings Conference Call
IceCure Medical Q4 2024
00:00 / 00:00

Transcript Sections

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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
Michael Polyviou
Head of Investor Relations at IceCure Medical

Thank you, Yoni, and welcome to IceCure Medical's conference call to review the financial results as of and for the 12 months ended December 31st, 2024, and provide an update on recent operational highlights. You may refer to the earnings press release that we issued earlier this morning. Participating in today's call are IceCure Medical 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 that 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 expects, anticipates, intends, plans, believes, seeks, estimate, 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 forward-looking statements in this presentation when we discuss prospective U.S. FDA de novo marketing authorization for ProSense in 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 U.S. 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 XSense 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.

Michael Polyviou
Michael Polyviou
Head of Investor Relations at IceCure Medical

Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of IceCure 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 factor section of the company's annual report on Form 20-F for the year ended December 31st, 2024, filed with the Securities and Exchange Commission on March 27th, 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.

Michael Polyviou
Michael Polyviou
Head of Investor Relations at IceCure Medical

This conference call contains time-sensitive information and speaks only as of the live broadcast today, March 27th, 2025. 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, including 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. Hello, everyone, and 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 Asia. We continue to see adoption of ProSense cryoablation and MRI indication 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 St. Gallen 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 St.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Gallen, including data of ICE3, illustrating a growing interest of 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 pre-conference 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.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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, as a public forum that delved deeply into our ICE3 data and evaluated ProSense's potential impact on women's health, reached a large number of doctors and patients who had not been previously aware of our minimally invasive cryoablation treatment as an alternative to standard of care lumpectomy.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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 U.S. As a result, our U.S. 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, XSense. It is already FDA-cleared in the U.S. and 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 to go over the numbers.

Ronen Tsimerman
Ronen Tsimerman
CFO and COO at IceCure Medical

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 12 months ended December 31st, 2024, product sales increased by 8% to $3.19 million compared to $2.96 million for the 12 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.

Ronen Tsimerman
Ronen Tsimerman
CFO and COO at IceCure Medical

Total revenue, when including revenue recognition and other services from the Terumo Corporation agreement in Japan, was up slightly to $3.29 million for the 12 months ended December 31st, 2024, as compared to $3.23 million for the 12 months ended December 31st, 2023, due to the increase in product sales, which was partially offset by a decrease in revenue recognition and other services in Japan of $100,000 and $274,000 in the 12 months of 2024 and 2023, respectively. Gross profit increased by 12% for the 12 months ended December 31st, 2024, to $1.45 million from $1.3 million for the 12 months ended December 31st, 2023. Gross margin increased to 44% for the 12 months ended December 31st, 2024, compared to 40% in the 12 months ended December 31, 2023.

Ronen Tsimerman
Ronen Tsimerman
CFO and COO at IceCure Medical

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 12 months ended December 31st, 2024, compared to $1.03 million for the 12 months ended December 31st, 2023. Non-GAAP gross margin for the 12 months ended December 31st, 2024, increased to 42% from 35% for the 12 months ended December 31st, 2023. Reconciliations of these non-GAAP figures are included in the earnings press release that we issued earlier today. Total operating expenses for the 12 months ended December 31st, 2024, were $17.15 million compared to $16.89 million for the 12 months ended December 31st, 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.

Ronen Tsimerman
Ronen Tsimerman
CFO and COO at IceCure Medical

Net loss increased slightly by 5% to $15.32 million or $0.30 per share during the 12 months ended December 31st, 2024, compared to a net loss of $14.65 million or $0.32 per share for the same period last year. As of December 31st, 2024, the company had cash and cash equivalents of approximately $7.6 million. As of March 24, 2025, the company had cash and cash equivalents of approximately $6 million. Between January 13th, 2025, and March 24th, 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 facility. 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.

Ronen Tsimerman
Ronen Tsimerman
CFO and COO at IceCure Medical

Our stable and growing gross profit margins on sales of products, combined with increases in sales, position us well as we await 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.

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. If you wish to decline from the polling process, please press star two. Please stand by while we poll for your questions. The first question is from Kemp Dolliver of Brookline Capital Markets. Please go ahead.

Kemp Dolliver
Analyst at Brookline Capital Markets

Great. Thank you for taking my question. I had noticed recently that you had a cryoablation procedure done at Emory Hospital in the U.S., and I'm curious how much other similar activity is going on right now as you await FDA approval and what investments you've made so far in a U.S. commercial effort. Thanks.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah. Thank you, Kemp. This is Eyal. We have other activities. We are not published some of the names if they are not allowing us to do it, but Emory started to work with publication on UCLA, Mayo Clinic, and other important sites in the U.S. participating to treat breast tumors, as well as other private and mid-clinics. All of the sales that we had in 2024 was related to breast tumors.

Kemp Dolliver
Analyst at Brookline Capital Markets

That's great. How many people do you have in the U.S. now?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah. I think that we mentioned it in the past. At the moment, we have our small, very focused team, two sales reps, a VP, and Mr. Shad Good, the Vice President, Sales for North America, who is bringing with him over 20 years of experience in the breast field, mainly from Johnson & Johnson, Mammotome, and others. We have one clinical support lady, so the team is very focused, four of them. As soon as we will get the FDA, 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
Analyst at Brookline Capital Markets

That's great. Thank you.

Operator

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

Anthony Vendetti
Analyst at Maxim Group LLC

Yes, thanks. Just, Eyal, I was just wondering if you could just give a little more color. The FDA seems to be taking their time. I'm wondering if that's just because it's such a—it's a new application. Is there anything that you can elaborate on in terms of staffing over at the FDA or your conversations with them? A follow-up to that is, have you delayed any sales hiring, or are you still moving forward with the expectation that this isn't that far off? Thank you.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Thank you, Anthony. I think that it's a combination that everyone heard and we saw in some of even the big players' yearly reports that they are facing some delay due to the evolving situation with the FDA, which, of course, affected to some way on a different team in the FDA. Again, due to the really importance of this indication to the health public and to the medical community, many stakeholders of the FDA are part of it. I think that one of the teams that's really affected by the President Trump administration decision and efficiency is the team that's mainly dealing with the post-marketing study. We have continuous discussion, and we are fully engaged like the core team of the FDA.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

They are bringing the rest of the team in order to fast forward for decision, and we all believe that we will get the clearance for that.

Anthony Vendetti
Analyst at Maxim Group LLC

Okay. In terms of timing, it's hard to say other than, obviously, it's not going to happen before the end of March. In terms of how soon in, let's say, the second quarter, is it too difficult to say at this point?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah. Yeah. Yeah. We cannot point on a specific date as of now, but we have a continuous discussion, full engagement from our side, from their side, in order to finalize it.

Anthony Vendetti
Analyst at Maxim Group LLC

Okay. In terms of Japan, can you provide an update on the timing of your expectation for submitting a regulatory filing in Japan?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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

Anthony Vendetti
Analyst at Maxim Group LLC

Okay. Great. Great. Okay. I'll hop back into the queue. Thanks so much.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Thank you.

Operator

If there are any additional questions, please press star one. If you wish to cancel your request, please press star two. Please stand by while we poll for more questions. The next question is from Yi Chen of H.C. Wainwright. Please go ahead.

Eduardo Martinez-Montes
Eduardo Martinez-Montes
Analyst at H.C. Wainwright & Co

Hi. This is Eduardo on for Yi. I had a question regarding XSense 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
Eyal Shamir
CEO at IceCure Medical

Oh, yes. Thank you very much. The first market, as I mentioned earlier, we got the FDA clearance on the XSense. We are planning to do a soft launching early next year. For the long run, this will be the product in the future which will upgrade and replace the ProSense with our current flagship product. We are planning to do a submission in other markets 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 needs. This is our next generation.

Eduardo Martinez-Montes
Eduardo Martinez-Montes
Analyst at H.C. Wainwright & Co

I see. I see. I guess I'm curious. The ProSense, if it's approved this year, do you envision it kind of only generating revenue for 2025 and then a slow transition towards XSense in the future?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

The ProSense is the approved product now globally. Now we are seeking in the U.S. to get the specific indication of treating low-risk early-stage breast cancer, which 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 U.S. We will start in 2026 with a soft launching in the U.S., and we will continue after we will get all the regulatory approvals in other markets. It will not stop any sales.

Eduardo Martinez-Montes
Eduardo Martinez-Montes
Analyst at H.C. Wainwright & Co

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. Please stand by while we poll for more questions. 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
Eyal Shamir
CEO at IceCure Medical

Thanks for participating on 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 ProSense. Have a good day, everyone.

Operator

Thank you. This concludes the IceCure 2024 year-end results conference call. Thank you for your participation. You may go ahead and disconnect.

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