IceCure Medical Q4 2024 Earnings Call Transcript

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March 27, 2025

There are 7 speakers on the call.

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 Polifieux.

Operator

Please go ahead.

Speaker 1

Thank you, Yoni, and welcome to Icicle Medical's conference call to review the financial results as of and for the twelve months ended 12/31/2024, 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 iSecure Medical CEO, Eyal Shamir and company CFO and Chief Operating Officer, Ronen Zimmerman. 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 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.

Speaker 1

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 respective US FDA de novo marketing authorization of 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 market.

Speaker 1

The expected filing by Terumo Corporation for regulatory approval for ProSense for breast cancer in Japan, that regulatory approval for XANT 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 ICE CURE's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Vice Chair 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 12/31/2024 filed with the Securities and Exchange Commission on 03/27/2025, 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 contains time sensitive information and speaks only as of the live broadcast today, 03/27/2025.

Speaker 1

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

Speaker 2

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 process cryoablation in MRI syndication across the globe as evidenced by 33 investigator initiated studies presented and published during 2024, the majority of which were with respect of breast cancer. Other indication included kidney, kidney, lung, bone and soft tissue cancers.

Speaker 2

Early this March, we participated for the first time at the third 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 IceCube booth. We had six abstracts of ProsimSKY cryoablation at the Saint Gallen including data of I3 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 ProSens that may gain further momentum if the FDA responds February to our de novo marketing authorization request for early stage low risk breast cancer with endocrine therapy. Additionally, we will supporting a breast cryoablation course at the twenty twenty five Society of Breast Imaging Conference and a pre conference breast ultrasound course at the twenty twenty five American Society of Breast Surgeons Conference next month.

Speaker 2

As we continue to rate the FDA decision, we believe several factors are leading to a longer than expected timeline. This includes the novelty of ProSens as a medical device that destroy breast cancer tumors. If approved, ProSens will 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.

Speaker 2

The advisory panel, which include 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 I3 data and evaluated person's potential impact on women health, which 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 clear LAMPectomy. We believe this public forum as well as growing body of investigator initiative study around the world is and will generate rising interest in the persons in The U. S. As a result, our U.

Speaker 2

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, XSENCE. It is already FDA cleared in The U. S.

Speaker 2

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.

Speaker 3

Thank you, Eyal. As Eyal mentioned earlier, growth momentum continues for ProSense and we're particularly pleased with the forty two year over year sales increase in North America. For the twelve months ended 12/31/2024, product sales increased by 8% to $3,190,000 compared to $2,960,000 for the twelve months ended 12/31/2023, driven primarily by the increase in sales in North America, as well as in Europe, Japan and other territories in Asia. Total revenue, when including revenue recognition and other services from Terumo Corporation agreement in Japan was up slightly to $3,290,000 for the twelve months ended 12/31/2024, as compared to $3,230,000 for the twelve months ended 12/31/2023 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 $2,274,000 in the twelve months of 2024 and 2023 respectively. Gross profit increased by 12% for the twelve months ended 12/31/2024 to $1,450,000 from $1,300,000 for the twelve months ended 12/31/2023.

Speaker 3

Gross margin increased to 44% for the twelve months ended 12/31/2024 compared to 40% in the twelve months ended 12/31/2023. Non GAAP gross profit which represents gross profit from sales of our products not including revenue recognition from Japan increased by 32% to $1,350,000 for the twelve months ended 12/31/2024 compared to $1,030,000 for the twelve months ended 12/31/2023. Non GAAP gross margin for the twelve months ended 12/31/2024 increased to 42% from 35% for the twelve months ended 12/31/2023. 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 12/31/2024 was $17,150,000 compared to $16,890,000 for the twelve months ended 12/31/2023.

Speaker 3

The slightly 2% increase was due to an increase in sales and marketing expenses, partially offset by reduction in research and development and general and administrative expenses. Net loss increased slightly by 5% to $15,320,000 or $0.3 per share during the twelve months ended 12/31/2024 compared to a net loss of $14,650,000 or $0.32 per share for the same period last year. As of 12/31/2024, the company had cash and cash equivalents of approximately $7,660,000 As of 03/24/2025, the company had cash and cash equivalents of approximately $6,000,000 Between 01/13/2025 and 03/24/2025, the company raised $2,600,000 in net proceeds from sales of $2,047,277 ordinary share 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. 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.

Speaker 3

Operator, we will now open the call for Q and A.

Operator

Thank you. Ladies and gentlemen, we will now open the call for the question and answer session. The first question is from Kempe D'Alevar of Brookline Capital Markets. Please go ahead.

Speaker 4

Great. Thank you for taking my question. So I had noticed recently that you had a procedure prior ablation 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.

Speaker 4

S. Commercial effort? Thanks.

Speaker 2

Yes. Thank you, Kempe. This is Eyal. We have other activities. We are not published some of the names if they are not allowing us to do it.

Speaker 2

But Emory started to work with sub 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. And all of the sales that we had in 2024 was related to breast tumors.

Speaker 4

That's great. And how many people do you have in The U. S. Now?

Speaker 2

I think that we mentioned it in the past at the moment. We have our small very focused team, two sales reps, VP and Mr. Sadhguru, the Vice President Sales for North America, who is bringing with him over twenty years of experience in the breast field mainly from Johnson and Johnson, Marmotone and others. And we have one clinical support Maybe for the team is very focused, four of them. And 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.

Speaker 4

That's great. Thank you.

Operator

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

Speaker 5

Yes, thanks. So I just, 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 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 have you delayed any sales hiring or are you still moving forward with the expectation that this isn't that far off?

Speaker 5

Thank you.

Speaker 2

Thank you, Anthony. So 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. And again, due to the really important of this indication to the health public and to the medical community, many stakeholders of the FDA is part of it. I think that one of the teams that really affected by the Trump, President Trump administration decision and efficiency is the team that mainly dealing with the post marketing study, but we have continuous discussion and we are fully engaged like the core team of the FDA, 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

Speaker 5

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

Speaker 2

Yes. 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.

Speaker 5

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?

Speaker 2

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

Speaker 5

Okay, great, great. Okay, I'll hop back in the queue. Thanks so much. Thank

Operator

The next question is from Yi Chen of H. C. Wainwright. Please go ahead.

Speaker 6

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 direct competitor? Do you see it kind of targeting different markets or users?

Speaker 2

Yes, the first, thank you very much. The first market as I mentioned earlier, we got the FDA clearance on the Exynx. We are planning to 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.

Speaker 5

The

Speaker 2

ProSense is our current flagship product. We are planning to do a submission in other markets and under the MDR. So this is our future platform technology, which in some point will upgrade and will replace the process, but we have the system in order to fulfill all the market's needs. This is our next generation.

Speaker 1

I see, I see. So I guess

Speaker 6

I'm curious, so the ProSense, if it's approved this year, you mentioned that kind of only operating generating revenue for 2025 and then a slow transition towards Accent in the future?

Speaker 2

The ProSENCE is 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.

Speaker 2

S. We will start in 2026 with soft launching in The U. S. And we will continue after we will get all the regulatory approvals in other markets, but it will not stop any sense.

Speaker 6

Understood. Thanks. That's really helpful.

Operator

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.

Speaker 2

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 catalyst this year include interim data from our iSECRET kidney cancer study, the rumor application to 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 ICE CURE twenty twenty four year end results conference call. Thank you for your participation. You may go ahead and disconnect.

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Earnings Conference Call
IceCure Medical Q4 2024
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