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DATE

  • Wednesday, May 28, 2025 at 10 a.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Eyal Shamir
  • Chief Financial Officer and Chief Operating Officer — Ronen Tsimerman

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TAKEAWAYS

  • Revenue: $725,000 in revenue for the three months ended March 31, 2025, primarily from a rise in North America and Europe, offset by lower sales in Asia.
  • Gross Profit: $218,000 in gross profit for Q1 2025, resulting in a gross margin of 30%, down from 36% a year earlier.
  • Operating Expenses: $3.88 million compared to $3.92 million in the prior-year period.
  • Net Loss: $3.59 million, or $0.06 per share, for the three months ended March 31, 2025, versus a net loss of $3.61 million, or $0.08 per share, in Q1 2024.
  • Cash Position: $4.0 million as of March 31 and $6.2 million as of May 27, which includes a $2 million unsecured bridge loan from Epoch Partner Investments.
  • North America YOY Revenue Growth: 11%.
  • Europe YOY Revenue Growth: 60%.
  • Asia Revenue Decline: Japan revenue fell about 60% year over year; other Asia geographies down about 40% year over year, with overall low figures in both regions.
  • At-the-Market Offering Proceeds: $2.65 million in net proceeds raised from Jan. 13 through May 27, 2025, via sales of 2,124,429 ordinary shares.
  • FDA Interaction: The company met with the FDA in April, submitting a required post-market study plan as the final prerequisite for a marketing authorization decision on ProSense for early-stage, low-risk breast cancer in women aged 70 and older.
  • Post-Market Study Scope: The post-market study will require 400 patients at a minimum of 25 sites, according to CEO Shamir.
  • Expected Patient Recruitment Timeline: Recruitment targeted for completion within three years, pending FDA discussion.
  • Commercial Readiness: IceCure plans for immediate U.S. commercial launch of ProSense for the new indication, with sales and study run in parallel upon FDA approval.
  • Base Reimbursement: U.S. treatment facility reimbursement for the CPT code stands at $3,800; expanded reimbursement may follow regulatory milestones.
  • Reimbursement Strategy: Management stated they intend to pursue a CPT1 code post-authorization to include physician fees in reimbursements.
  • Geographic Expansion: Partner Terumo aims to file for regulatory approval in Japan in 2H 2025, targeting over 100,000 new breast cancer cases annually in Japan, most of which are early stage.
  • Commercial Model: Shamir indicated a mix of "60/40 between placement and selling the consoles" is expected, with probe purchase commitments on placements.
  • Sales Team Expansion: IceCure will scale its U.S. salesforce after FDA authorization, with experienced management already in place.
  • Shareholder Support: A $2 million unsecured loan from Epoch demonstrates continued major shareholder backing, according to management statements.
  • Tariffs: CFO Tsimerman confirmed the company has been affected by U.S. tariffs, but future presidential decisions may alter that impact.

SUMMARY

IceCure Medical's (ICCM 0.97%) quarterly call reflected stable operating expenses and a nearly unchanged net loss compared to the same period in 2024, despite a slight decrease in revenue and gross margin compared to the same period in 2024. Ongoing FDA engagement was highlighted by the submission of a sizeable post-market study plan, with leadership involvement from the FDA's Center for Devices and Radiological Health, but no set decision timeline. Cash reserves increased after both a bridge loan from its largest shareholder and new share offerings, enhancing the company's liquidity.

  • Management emphasized that commercial acceleration and material revenue growth are contingent on favorable FDA marketing authorization for ProSense.
  • Shamir said, "FDA granting ProSense cryoablation marketing authorization in early-stage breast cancer for women aged seventy and older, we will commence commercial sales for this indication while simultaneously running the post-market study."
  • The company is positioning for broader reimbursement by targeting a transition from CPT3 to CPT1 code status after regulatory milestones are achieved.
  • IceCure reported "high level of interest in ProSense" from surgeons and clinicians at the major American Society of Breast Surgeons 2025 meeting, anticipating future adoption following approval.
  • Geographical diversification remains a focus, with a near-term goal of regulatory filings in Japan and Israel in addition to the U.S. market.

INDUSTRY GLOSSARY

  • CPT Code: Current Procedural Terminology code, a billing code for U.S. medical procedures and reimbursement.
  • CPT3 vs. CPT1: CPT3 codes are temporary tracking codes; CPT1 codes are permanent, established reimbursement codes that include physician payment.
  • Cryoablation: A minimally invasive technique that destroys tissue, including tumors, by freezing.
  • Post-Market Study (PMS): A clinical study conducted after a product's regulatory approval to monitor real-world safety and effectiveness.

Full Conference Call Transcript

Michael Polyviou: Thank you, and welcome to IceCure Medical Ltd's conference call to review the financial results as of and for the three months ended March 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 IceCure Medical Ltd CEO, Eyal Shamir, and company CFO and COO, Ronen Tsimerman. Before we begin, I will now take a moment to read a statement about our forward-looking statements. This call and the question and answer session that follows it 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, 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 a prospective post-market study plan and our beliefs and expectations following our meeting with the FDA at the end of April. The expectation of the FDA's final marketing authorization decision will depend 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 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 these statements during this call. The forward-looking statements contained or implied during this call are subject to such 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 SEC on March 27, 2025. It 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, May 28, 2025. I will now turn the call over to IceCure Medical Ltd CEO, Eyal Shamir. Eyal, please go ahead.

Eyal Shamir: Thanks, Michael, and hello, everyone, and thank you for joining us today to review our first quarter 2025 results as we continue to experience momentum and continuous growth in ProSense system and disposable probe sales in North America. Ronen will provide further detail on the company's financial performance in the first quarter, and I will focus my comments on more recent developments, namely the positive high-level meeting we had with the FDA at the end of April.

We met with the leadership of the FDA and its Center for Devices and Radiological Health (CDRH) to discuss our marketing authorization request for ProSense in the treatment of early-stage low-risk breast cancer when combined with adjuvant endocrine therapy for women aged seventy and over, a demographic comprising approximately 46,000 patients annually in the US. During the meeting, the FDA requested that we conduct a post-market study after marketing authorization has been granted, which we believe represents a positive signal. The FDA requested that we prepare this post-market study plan and deliver it to the Center for Devices and Radiological Health (CDRH) for review and comments. The FDA's decision on marketing authorization is expected upon the post-market study plan's approval.

I am pleased to report that after the team's diligent work to prepare the plan, we recently submitted it to the Center for Devices and Radiological Health office for review. As you all well know, we have been anticipating the FDA decision on cryoablation for early-stage breast cancer since the beginning of the year. 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 ProSense cryoablation marketing authorization in early-stage breast cancer for women aged seventy and older, we will commence commercial sales for this indication while simultaneously running the post-market study.

This would afford the company access to reimbursement under the CPT code, which covers $3,800 for the treatment facility cost. We believe that additional reimbursement may become available based on regulatory approval and any recommendations from professional medical associations. Our US 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 a 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 Surgeons 2025 annual meeting, which took place in early May.

We were encouraged by the high level of interest in ProSense 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 ProSense to their patients following marketing authorization. Moreover, ASBRS leadership is giving breast cryoablation a good deal of attention over the past years, including this year. So we believe that this and the positive recommendation of the FDA advisory committee meeting in November 2024 give us an awareness advantage through the FDA marketing authorization agreement. Cryoablation for breast cancer was included in a prominent presentation, including the American Society of Breast Surgeons' presidential address and its best paper tool for 2024 review.

As our ICE3 study was named one of the best papers of the year. In addition to the ASBRS, we are receiving new interest in ProSense from interventional radiologists and other doctors following the FDA request for a post-market plan. As we await the FDA decision, we also look ahead to other potential catalysts for the rest of 2025, including regulatory filings and potential approvals in Japan and in Israel. Meanwhile, the number of published independent studies of ProSense continues 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 Lei Shen, of Epoch Partner Investments 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 million unsecured loan through Epoch at an interest rate that matches the US federal bills. This bridge loan will be prepaid prior to its one-year term or upon Epoch's participation in an equity transaction. This loan affords us additional flexibility as we await the FDA decision. I will now turn the call over to Ronen.

Ronen Tsimerman: Thank you, Eyal. For the three months ended March 31, 2025, revenue representing ProSense system and disposable probe sales was $725,000 compared to $743,000 for the three months ended March 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 March 31, 2025, was $218,000 compared to $269,000 for the three months ended March 31, 2024. Gross margin was 30% for the three months ended March 31, 2025, compared to 36% in the three months ended March 31, 2024.

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 infrastructures and scale sales. We do not expect a material change in revenues before receiving the FDA marketing authorization decision. Total operating expenses for the three months ended March 31, 2025, were $3.88 million compared to $3.92 million for the three months ended March 31, 2024. Net loss was $3.59 million or $0.06 per share for the three months ended March 31, 2025, compared to a net loss of $3.61 million or $0.08 per share for the same period last year.

As of March 31, 2025, the company had cash and cash equivalents, including short-term deposits, of approximately $4.0 million. As of May 27, 2025, we had cash and cash equivalents of approximately $6.2 million, which includes the $2 million unsecured bridge loan from Epoch. Between January 13, 2025, and May 27, 2025, the company raised $2.65 million 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&A.

Operator: Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. The numbers will be taken in the order they are received. Please stand by while we poll for your questions. The first question is from Anthony Vendetti of Maxim Group. Please go ahead.

Anthony Vendetti: Yes. Hi. Good morning, Eyal, Ronen. I am glad to hear that you have submitted the proposed post-market study to the FDA. I think that's a significant milestone. Just as you mentioned, the CDRH, the 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: Hi, Anthony. This is Eyal. Yes, the post-market study, which is in the last few years, is pretty common for de novo approvals, will require 400 patients in at least 25 sites. The top management of CDRH, including the director's office, promised us that top management will continue to review it, and they will be part of the process on top of the review team, but they cannot guarantee us a specific time. We submitted quite a big package, and I am sure that they will review it, and we will have a continuous discussion like we did until now.

Anthony Vendetti: Okay. I am just curious about 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: Quite a lot. You know, it's a lot of information.

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

Eyal Shamir: 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: Recruitment within three years. Okay. Thanks. So the 400 patients should be recruited during three years.

Eyal Shamir: Yes.

Anthony Vendetti: 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: As soon as we have more records, more claims 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 to what we heard from our reimbursement consultant, that we will be able to increase the CPT in its record. This is number one. Number two, after the FDA grants us the marketing authorization, we will be able to apply to AMA to move from CPT3 to CPT1, which includes also the physician fee.

In parallel, we are doing all the preparation for that meta-analysis and some other requirements that need to be part of the AMA. We will apply to the AMA. It will be a process, but we will seek a CPT1 code.

Anthony Vendetti: Okay. Great. And then just lastly, before I jump back in the queue, Terumo, your partner in Japan, is still on schedule to file for approval in the second half of 2025. What is the size of the population there? I know in the press release, 46,000 women are potential candidates for the ProSense system. What about Japan? What's the size of the market or the opportunity there?

Eyal Shamir: The total number of patients that have breast cancer is a bit more than 100,000, between 100,000 and 105,000 new cases every year. Very similar to the US, almost two-thirds of them are low-risk early-stage breast cancer.

The assumption that Terumo presents at the moment is that it will not be with the limitation of age and even tumor size, or maybe very similar to what we have in the CE and many other regulatory approvals listed just as breast cancer, which does not include any limitation or even like an independent study that runs now in Europe by one of the top three centers in Europe for oncology that they are doing patients who are fifty and up in both luminal A and luminal B. So it cannot be that limited like we are going to have in the US at the beginning.

Anthony Vendetti: 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: Great. Thank you. Can you give any more details on the geographic breakdown of revenue this quarter? You know, how much growth you saw in the U.S. and North America, and the size of the decline in Asia?

Ronen Tsimerman: Hi, and thank you for the question, Kemp. 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, so the decrease was about 60%. And again, the numbers fluctuate between quarters and also in other parts of Asia, about 40%. But again, the numbers are fluctuating, and they weren't very big anyway.

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

Ronen Tsimerman: Yes. Probes and system sales, there was no revenue.

Kemp Dolliver: Great. Thank you.

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

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

Ronen Tsimerman: 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 initially, yes, we were affected or influenced by the tariffs that were stated by the US Administration.

Eduardo: 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: Yes. Hi. This is Eyal. Yes, of course, after we have the marketing authorization grant, we plan to increase the sales team. We have a very professional team starting from North America, led by Mr. Shad Good, who is bringing over twenty years of experience in the breast field from J&J and Mammotome, and others. So we will build the teams with sales reps, regional sales managers, technical applications, and we plan that quite an important part of our future growth will come from the US market.

Eduardo: Understood. And kind of also curious what strategies you guys have for pricing and sales. Specifically, do you guys primarily focus on purchasing outright? Do 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: I believe that it will be, you know, kind of a 60/40 between placement and selling the consoles. Like, you know, it's pretty common in this type of capital equipment or maybe half and half. But 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 separate business model where we will sell the console and, of course, the single-use probe.

Eduardo: 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: Thanks for participating in today's call. We look forward to the FDA decision on marketing authorization of ProSense 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 ProSense and has the potential to accelerate adoptions. Our U.S. sales team is ready, and they are fielding questions from prospective standard sites at this time. We hope to report back to our shareholders soon with further news. Have a great day, everyone.

Operator: Thank you. This concludes the IceCure Medical Ltd First Quarter 2025 Results Conference Call.