IceCure Medical Q1 2025 Earnings Call Transcript

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May 28, 2025
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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.

Operator

Please be advised that today's conference is being recorded. I would now like to turn the conference over to Michael Poliview. Please go ahead.

Michael Polyviou
Managing Member at EVC Group LLC

Thank you, Ioanni, and welcome to iSecure Medical's conference call to review the financial results as of and for the three months ended 03/31/2025, 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 iSecure Medical's CEO, Eyal Schmear and company's CFO and COO, 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 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.

Michael Polyviou
Managing Member at EVC Group LLC

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 our prospective post market study plan and our beliefs and expectations following our meeting with the FDA at the April. The expectation of the FDA's final marketing authorization decision for Prosent upon approval of the post market study plan or plan to commence commercial sales in parallel with running our post market study our belief that additional reimbursements may become available based on regulatory approval and our potential catalysts for the rest of 2025. Because such statements deal with future events and are based on iSCure's current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of iSCure 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 SEC on 03/27/2025, which is available on the SEC's website at www.sec.gov.

Michael Polyviou
Managing Member at EVC Group LLC

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 live broadcast today, 05/28/2025. I will now turn the call over to ICHERE Medical's CEO, Eyal Shamir. Eyal, please go ahead.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

Thanks, Michael, and hello, everyone, and thank you for joining us today to review our first quarter twenty twenty five results as we continue to experience momentum and continuous growth in process system and disposable probe sales in North America. Ronen will provide further detail on the company financial performance in the first quarter and I will focus my comments on more recent development, namely the positive high level meeting we had with the FDA at the April. We met with the leadership of the FDA and its Center of Device and Radiology has CDRH to discuss our marketing authorization request for PROCENT in the treatment of early stage low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over. A demographic comprising of approximately 46,000 patients annually in The U. S.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

During the meeting, the FDA requested that we will conduct a post market study after marketing authorization has been granted, which we believe represents a positive signal. The FDA requested that we will prepare this post market study plan and delivery to the center of the VITES and Radiology Health CVRH for review and comments. The FDA's decision on marketing authorization is expected upon the post market study plan's approval. I'm pleased to report that after the team's diligent work to prepare the plan, we recently submitted each to the Center of the Vice and Radiology Health for its review. As you all well known, we have been anticipating the FDA decision on cryoablation for early stage breast cancer since the beginning of the year.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

It is our hope that the review of our post market study plan will be the final step leading up to an FDA decision about which we are optimistic. Upon the FDA granting Prosence cryoablation marketing authorization in early stage breast cancer for women aged 70 and older, we will commence a commercial phase for this indication while simultaneously running the post market study, which would afford the company access to reimbursement under the CPT three code, which covers $3,800 for the treatment facility cost. We believe that additional reimbursement may become available based on regulatory approval and any recommendation from professional medical associations. Our U. S.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

Commercial team is ready and eager to serve doctors and patients to deliver ProSense, which would become the first in class minimally invasive option for women. We see this as a major advancement in women's health and the new paradigm in breast cancer care. The news of the FDA request for our post market plan was well timed and very well received at the American Society of Breast Cellular twenty twenty five Annual Meeting, which took place in early May. We were encouraged by high level of interest in ProSens as a large number of breast surgeons approached our booth asking how they could participate in our planned post market study and how they could offer ProFenze to their patients following marketing authorization. Moreover, ASBRS leadership has given breast cryoablation as a good deal of attention over the past years, including this year.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

So, we believe that this and the positive recommendation of the FDA Advisory Committee meeting in November 2024 give us an awareness advantage should the FDA marketing authorization be granted. Prior ablation for breast cancer was included in a prominent presentations including the American Society of Breast Surgeons Presidential Address and it is best paper for 2024 review. As our I3 study was named one of the best paper of the year. In addition to the ASBRS, we are receiving a new interest in presence from interventional radiologists and other doctors following the FDA request for a post market plan. As we wait the FDA decision, we also look ahead to other potential catalysts for the rest of 2025, including regulatory filing and potential approvals in Japan and in Israel.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

Meanwhile, the number of published independent study of PROCENT continued to increase globally. Before I turn the call over to Ronen to review our Q1 results, I want to comment on the continued support and friendly relationship we enjoy with our largest shareholder, Mr. Li Hai Xiang of Epoch Partner Investor Limited. Epoch and Mr. Li also a board member of the company once again demonstrated confidence in our company, our technology and our ability to execute our business plan by providing a $2,000,000 unsecured loan through Epoch and at an interest rate that matches The U.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

S. Special bills. This bridge loan will be prepaid prior to its one year term upon airport participation in an equity transaction. This loan affords us additional flexibility as we wait the FDA decision. I will now turn the call over to Ronald.

Ronen Tsimerman
Ronen Tsimerman
CFO & COO at IceCure Medical

Thank you, Eyal. For the three months ended 03/31/2025, revenue representing Process System and Disposable Probe sales was 7 and $25,000 compared to $743,000 for the three months ended 03/31/2024. Revenue was driven primarily by the increase in sales in North America and Europe, offset by a decline in sales in Asia. Gross profit for the three months ended 03/31/2025 was $218,000 compared to $269,000 for the three months ended 03/31/2024. Gross margin was 30% for the three months ended 03/31/2025, compared to 36% in the three months ended 03/31/2024.

Ronen Tsimerman
Ronen Tsimerman
CFO & COO at IceCure Medical

Due to the low revenue base, we continue to expect revenue and gross profit to fluctuate quarter to quarter as we focus on building out our commercial infrastructure scale sales. We do not expect a material change in revenues before receiving FDA marketing authorization decision. Total operating expenses for the three months ended 03/31/2025 were $3,880,000 compared to $3,920,000 for the three months ended 03/31/2024. Net loss was $3,590,000 or $0.06 per share for the three months ended 03/31/2025, compared to a net loss of $3,610,000 or $0.08 per share for the same period last year. As of 03/31/2025, the company had cash equivalents including short term deposits of approximately $6,000,000 As of 05/27/2025, we had cash and cash equivalents of approximately $6,200,000 which includes the $2,000,000 unsecured bridge loan from Epoch.

Ronen Tsimerman
Ronen Tsimerman
CFO & COO at IceCure Medical

Between 01/13/2025 and 05/27/2025, the company raised $2,650,000 in net proceeds from the sales of 2,124,429 ordinary shares under its at the market offering facility. Operator, we will now open the call for Q and A.

Operator

Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. Your questions will be polled The first question is from Anthony Vendetti of Maxim Group. Please go ahead.

Anthony Vendetti
Executive Managing Director at Maxim Group

Yes. Hi. Good morning, Yael, Ronen. So I'm glad to hear that you have submitted the proposed post market study to the FDA. That's significant milestone.

Anthony Vendetti
Executive Managing Director at Maxim Group

Just as you mentioned that the CDRH, Center for Devices and Radiological Health at the FDA, is the division within the FDA that is going to review and ultimately decide on the approval of the post market study. First, is it still expected to be a minimum of 400 patients over 25 sites? And is there any indication from the FDA when they would potentially respond to the submission of your post market study? Thanks.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

Hi, Anthony. This is Eyal. Yes, it still will be the post market study, which is in the last few years, it's pretty common for de novo approvals, will require 400 patients in at least 25 sites. The top management of CDRH and including the director officer promise us that top management will continue to review it and they will be part of the process on the top of the review team, but they cannot guarantee us specific time. We submitted quite a big package and I'm sure that they will review it and we will have a continuous discussion like we did until now.

Anthony Vendetti
Executive Managing Director at Maxim Group

Okay. I'm just curious with how I know these packages are fairly large and voluminous in terms of length. Approximately how many pages was the package that you submitted?

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

Quite a lot. It's a lot of information.

Anthony Vendetti
Executive Managing Director at Maxim Group

Okay. And then assuming that the study is reviewed and approved, how long is that study, the post market study expected to take?

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

This is not yet finalized with the FDA, but I believe from what we saw in other PMS that the FDA would like to see that the recruitment time will be within three years.

Anthony Vendetti
Executive Managing Director at Maxim Group

Recruitment within three years. Okay.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

So the 400 patients should be recruited during three years.

Anthony Vendetti
Executive Managing Director at Maxim Group

Okay. And you did mention in your prepared remarks that there's an opportunity potentially for expanded reimbursement. Can you get any more specific on what that potential is?

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

Structly, as soon as we will have more records, more claim on our specific code, CPT3 code for breast cancer and additional information on the actual cost that the site will put as part of the claims, we will be able to increase we believe and according what we heard from our consultant, reimbursement consultant that we will be able to increase the CPT in its record. This is number one. Number two, after the FDA will grant us the marketing authorization, we will be able to apply to AMA to move from CPT three to CPT one, which include also the physician fee. In parallel, we are doing all the preparation for that meta analysis and some other requirements that need to be as part of the AMA. So, will apply to the AMA.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

It will be a process, but will seek also CPT-one code.

Anthony Vendetti
Executive Managing Director at Maxim Group

Okay, great. And then just lastly before I jump back in the queue. Turomo, your partner in Japan is still on schedule to file for approval in the second half of twenty twenty five. What is the size of the population there? I know in the press release 46,000 women are potential candidates for the ProSens system.

Anthony Vendetti
Executive Managing Director at Maxim Group

What about Japan? What's the size of the market or the opportunity there?

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

The total number of patients that have breast cancer are a bit more than one hundred thousand, between one hundred thousand and one hundred and five thousand new cases every year, Very similar to The U. S, almost two thirds of them are low risk early stage breast cancer. The assumption that Terumo present at the moment that it will not be with limitation of age and even tumor size or maybe very similar to what we have by CE and many other regulatory approvals with just breast cancer, which not include any limitation or even like an independent study that run now in Europe by one of the top three centers in Europe for oncology that they are doing patients who are 50 and up in both Luminal A and Luminal B. So, it cannot be that limited like we are going to have in The U. S. At the beginning.

Anthony Vendetti
Executive Managing Director at Maxim Group

Okay. That's great to hear. Okay. Thanks so much. I'll hop back in the queue. Appreciate it.

Operator

The next question is from Kemp Dolliver of Berkline Capital Markets. Please go ahead.

Kemp Dolliver
Director - Research & Senior Analyst at Brookline Capital Markets

Great. Thank you. Can you give any more details on the geographic breakdown of revenue this quarter? How much growth you saw in U. S.

Kemp Dolliver
Director - Research & Senior Analyst at Brookline Capital Markets

And North America and size of the decline in Asia?

Ronen Tsimerman
Ronen Tsimerman
CFO & COO at IceCure Medical

Hi, and thank you for the question, Cam. So in North America, we've seen an increase of about 11% year over year. And in Europe, we've seen an increase of about 60 from again year over year. So we're very happy about it. In Japan, the numbers were not very big.

Ronen Tsimerman
Ronen Tsimerman
CFO & COO at IceCure Medical

So the decrease was about 60%. And again, the numbers fluctuate between quarters and also in other parts in Asia about 40%. But again, the numbers are fluctuating and they weren't very big anyway.

Kemp Dolliver
Director - Research & Senior Analyst at Brookline Capital Markets

Great. And these were entirely probe and system sales this quarter?

Ronen Tsimerman
Ronen Tsimerman
CFO & COO at IceCure Medical

Yes, yes. Probes and system sales, there was no revenue recognition this quarter.

Kemp Dolliver
Director - Research & Senior Analyst at Brookline Capital Markets

Great. Thank you.

Ronen Tsimerman
Ronen Tsimerman
CFO & COO at IceCure Medical

Thank you.

Operator

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

Eduardo Martinez-Montes
Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC

Hi, there. This is Eduardo on for Yi. Curious if there's the ProSense is subject to any of the new tariffs for U. S. Markets, kind of get some clarity on that.

Ronen Tsimerman
Ronen Tsimerman
CFO & COO at IceCure Medical

So yes, I will take the question. Thank you for the question. Yes, currently, we know that there is some kind of freeze of the taxes. But again, we will need to see it when President Trump decides exactly what to do. But at the initial, yes, we were affected or influenced by the tariffs that were stated by the U. S. Administration.

Eduardo Martinez-Montes
Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC

Understood. And I'm kind of curious if for the post market approval, once the study assuming the study goes through, do you guys plan to expand your sales team in addition to the ones you currently have?

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

Hi, this is Eyal. Yes, of course, after we will have the marketing authorization grant, we plan to increase the sales team. We have a very professional Vice President for North America, Mr. Chad Goode, who is bringing over twenty years of experience in the breastfeeding from J and J, Mammothome and others. So, we will build the team, sales rep, regional sales manager, clinical application, and we plan that quite important part of our future growth will come from The U. S. Market.

Eduardo Martinez-Montes
Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC

Understood. And kind of also curious what strategies you guys have for pricing and sales specifically, you guys primarily focus on purchasing outright, you guys have leases or pay per use agreements in place, kind of getting more clarity on your commercial strategies in that regard?

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

I believe that it will be kind of a sixtyforty between placement and selling the consoles. Like it's pretty common in this type of capital equipment or maybe half half. For placement, we will require a very important commitment of a monthly number of probes over two to three years for a higher price and we will have also a separated business model that we will sell the console and of course the single use probe.

Eduardo Martinez-Montes
Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC

Got it. That's helpful. Those are all my questions. Thank you.

Operator

Thank you. This concludes the question and answer session. I will turn the call over to Eyal Shamir for his concluding statements. Please go ahead.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

Thanks for participating on today's call. We look forward to the FDA decision on marketing authorization of of prons in early stage breast cancer. We also believe that the post market study should we receive the FDA marketing authorization, will drive further interest in ProSens and has the potential to accelerate adoption. Our U. S.

Eyal Shamir
Eyal Shamir
CEO & Director at IceCure Medical

Sales team is ready and they are fielding questions from prospective study sites at this time. We hope to revert back with our shareholders soon with further news. Have a great day everyone.

Operator

Thank you. This concludes the iCure first quarter twenty twenty five results conference call. Thank you for your participation. You may go ahead and disconnect.

Executives
    • Eyal Shamir
      Eyal Shamir
      CEO & Director
    • Ronen Tsimerman
      Ronen Tsimerman
      CFO & COO
Analysts
    • Michael Polyviou
      Managing Member at EVC Group LLC
    • Anthony Vendetti
      Executive Managing Director at Maxim Group
    • Kemp Dolliver
      Director - Research & Senior Analyst at Brookline Capital Markets
    • Eduardo Martinez-Montes
      Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC
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Key Takeaways

  • Management submitted its post-market study plan to the FDA and remains optimistic about obtaining marketing authorization for ProSense in early-stage, low-risk breast cancer for women 70+, enabling a parallel commercial launch with CPT-3 reimbursement.
  • First-quarter revenues rose by 11% in North America and 60% in Europe despite a 40% decline in Asia, while gross margin fell to 30% from 36% and net loss held steady at ~$3.6 million.
  • The company secured a $2 million unsecured bridge loan from its largest shareholder, bringing cash and equivalents to approximately $6.2 million as of May 27, 2025, extending its runway pending the FDA decision.
  • iSecure expects additional catalysts in 2025 with a Terumo-led regulatory filing in Japan in H2, potential approval in Israel, and a growing number of independent ProSense study publications globally.
AI Generated. May Contain Errors.
Earnings Conference Call
IceCure Medical Q1 2025
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