IceCure Medical Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 13, 2025

Key Takeaways

  • Positive Sentiment: After a productive meeting with the FDA’s Center for Devices and Radiological Health, iSCure is optimistic about securing de novo marketing authorization for ProSense by year-end 2025, pending completion of a post-market study.
  • Positive Sentiment: Independent clinical data, including a 17-year Japanese study of 600+ patients showing a 99% recurrence-free rate, are driving growing adoption of breast cryoablation.
  • Positive Sentiment: The company closed an oversubscribed $10 million rights offering, strengthening its cash position to support regulatory, clinical, and commercial initiatives through the FDA decision.
  • Negative Sentiment: First-half revenue declined to $1.25 million from $1.75 million year-over-year and gross margin fell to 28%, partly due to shipment delays amid regional conflict, resulting in a $6.95 million net loss.
  • Positive Sentiment: iSCure is seeing increased European demand and plans broad exposure at key September conferences like CIRSE and EUSOBI to drive further sales.
AI Generated. May Contain Errors.
Earnings Conference Call
IceCure Medical Q2 2025
00:00 / 00:00

There are 7 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by. Good morning and thank you for standing by. Currently, all 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.

Operator

I would now like to hand over the call to Michael Poliview. Please go ahead.

Speaker 1

Thank you, Yoni, and welcome

Speaker 2

to Ice Cure Medical's conference call to review the financial results as of and for the six months ended 06/30/2025, 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 iSture Medical's CEO, Al Schmear and the 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 it 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 2

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 that the company is optimistic that regulatory approval for process will be granted before year end 2025. The expectation that there is more clinical data forthcoming from independent researchers. The belief that the recent rights offering is a strong indicator and vote of confidence from the company's shareholders and that it will provide a sufficient cash runway for the anticipated FDA marketing authorization decision. The expectation that revenue and gross profits may continue vary quarter to quarter as the company focuses on building commercial sales commercial scale sales.

Speaker 2

The belief that the company's growth trajectory could meaningfully accelerate upon receiving the FDA's decision. The company's upcoming presentation at the H. C. Wainwright and Company Conference, participation in Maxim Group LLC's conference and the belief that the company's cash, cash equivalents and short term deposits position it in its strong financial position to continue executing across regulatory, clinical and commercial initiatives. The forward looking statements contained or applied 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 at www.sec.gov.

Speaker 2

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, 08/13/2025. In addition, during the course of the 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 iSCure Medical's CEO, Eyal Shmir. Eyal, please go ahead.

Speaker 3

Thanks, Michael, and hello, everyone, and thank you for joining us today to review our results for the 2025. This is a pivotal time for ICU as we are experiencing momentum building across several fronts, including regulatory, clinical and commercial. Let me begin with our regulatory progress in The U. S. For ProSims for the very important indication of early stage low risk breast cancer in women aged 70 and over combined with adjuvant endocrine therapy.

Speaker 3

We believe that this is a significant opportunity to change the paradigm of breast cancer care for the estimated of forty six thousand women in The U. S. Annually with the alternative to lumpectomy. In the second quarter, we concluded a productive meeting with leadership at the FDA Center of Devices and Radiological Health regarding our de novo marketing authorization request. Importantly, the FDA requested a post market study to be conducted after marketing authorization has been granted.

Speaker 3

The post market study has been fully submitted to the FDA. We believe the plan reflects a comprehensive and well structured approach. We were asked to provide additional information, which we are actively working to complete. Assuming the FDA funds the supplemental data satisfactory, we remain optimistic that approval will be granted before year end 2025. Meanwhile, we are also experiencing a positive shift in adoption in Europe, especially in breast cancer cryoablation.

Speaker 3

While PROSENSE is already approved in Europe for several indications, including breast cancer, we believe the increase in usage for breast cancer is being driven by the I3 results and the growing body of independent clinical evidence. We were off many more studies and expect more clinical data will be forthcoming from independent researchers that our commercial team is prepared to leverage to drive further adoption and utilization. POSIM was featured prominently during the second quarter and several high impact medical forum, including the American Breast Surgeons Annual Conference, Society of Breast Imaging Symposium and the European Conference on Interventional Oncology, demonstrating the growing interest in ProSens during the Society of Breast Imaging Symposium, both hands on breast cryoablation training courses were sold out. At the European Conference on Interventional Oncology, our technology was featured in a separate event, including data showing that ninety nine ninety one percent of patients would choose ablation over breast conserving surgery. Earlier in this quarter, Prosence was featured at the Japanese Breast Cancer Society Conference, which during the conference, a respected expert and present user, Professor Fukuma, presented seventeen years of data from over 600 best breast cancer patients showing a ninety nine percent recurrence free rate with cryoablation.

Speaker 3

I would like to repeat this message of this amazing follow-up and results. Seventeen years of follow-up for over six hundred breast cancer patients showing only one percent recurrence, which means ninety nine percent recurrence free rate, which is the biggest global clinical evidence using our technology. In summary, we are executing and laying the groundwork for future success. Recently, we strengthened our financial position with the closing of our $10,000,000 rights offering that was significantly oversubscribed. We believe that this is a strong indicator and a vote of confidence from our shareholder.

Speaker 3

We expect this to provide a sufficient cash runway for the anticipated FDA marketing authorization decision. Our largest shareholder and a Board member, Mr. Lirai Zhang of Epoch Partner Investment Limited participated in the rights offering. I will now turn the call over to Ronen.

Speaker 4

Thank you, Eyal. For the six months ended 06/30/2025, revenue was about $1,250,000 compared to $1,750,000 for the same period in 2024. As previously disclosed, over $200,000 in product shipments originally scheduled for Q2 were delayed due to the Israeli Iran conflict in June. These will be recognized in the third quarter. Gross profit for the 2025 was $349,000 compared to $799,000 in the prior year period.

Speaker 4

This resulted in gross margin of 28% versus 46% in the 2024. As we previously communicated, we expect revenue and gross profit may continue to vary quarter to quarter as the company focuses on building commercial scale sales. Overall, total operating expenses decreased to $7,390,000 for the six months period compared to $7,680,000 a year ago. This reflects our efforts to optimize spending without sacrificing commercial or regulatory execution. Net loss for the first half of twenty twenty five was $6,950,000 or $0.12 per share compared to a net loss of $6,690,000 or $0.14 per share in the same period last year.

Speaker 4

As of 06/30/2025, we had $5,380,000 in cash, cash equivalents and short term deposits, which included a $2,000,000 loan from our major shareholder. This excludes the $10,000,000 in gross proceeds raised from our rights offering, which closed at 08/01/2025.

Speaker 1

During the 2025, ICEQ raised $2,650,000 in net proceeds from the sales of 2,127,961

Speaker 4

ordinary shares under our at the market offering facility. We believe this puts us in a stronger financial position to continue executing across our regulatory clinical and commercial activities. We believe our growth trajectory could meaningfully accelerate upon receiving the FDA decision. To help raise awareness of iSQ story and broaden investor engagement, Eyal and I will be presenting at the next C.

Speaker 4

Wainwright Conference and will be participating at Maxim Conference in October. Operator, we will now open the call for Q and A.

Operator

We will now start the Q and A session. The Q

Speaker 1

and

Speaker 5

The first

Operator

question is from Kemp Dolliver of Brookline Capital Markets. Please go ahead.

Speaker 6

Hi, good day. What's the nature of the additional information that FDA requested?

Speaker 3

Hi, Kemp. Good morning and thank you for your question. This is Eyal, the CEO. The FDA would like to get quite important information around the post market study. As we announced, it's supposed to be after granting the approval.

Speaker 3

It's going to be 400 patients in 30 sites, and we need to conclude their participation of the patient recruitment of the patients within three years. So they would like to get some list of potential participating sites, some kind of a qualification form of the site and and to see the recruitment plan that we will be able to to conclude and to run the post market study after they will run to Estellator. So to build the confidence and the information that iQ will be able, like other companies that got de novo approval, that need to run this post market study. So just to be sure that we will be able to conduct it.

Speaker 6

Right. And I mean, going through this exercise lead you to increase your budget for recruiting for the trial for instance or do you expect the cost of the trial to be about the same as you previously suggested?

Speaker 3

We we are working now we are working now to to update the budget. Maybe Ronen could give some more light on it. But, you know, we work with their sites. Of course, you know, we need to have some support like any study from a CRO. And basically, it's a normal post market study.

Speaker 3

And we have also the current PPTs record that will be able to cover the cost of the probe and more for the sites. And we will work according a normal course of study.

Speaker 4

Yes. So the final budget will be decided when we have the full, let's call it, understanding with the FDA regarding all the requests. As they also the CRO, the costs of the follow-up and the payments to the facilities.

Speaker 6

Great. Thank you. And then question on the separate topic and that is given the expected timetable for an approval, are you still expecting, for instance, late twenty twenty six for CPT one code from AMA, possibly sooner from the other specialist societies? And are there any changes in how you're thinking about the build out of your commercial efforts as a result?

Speaker 3

I would start from the last part of your questions. As soon as we will get the clearance, we have Mr. Chad Gudas, our VP of Sales for North America, who is bringing over twenty years of experience in breast fields from Velje, Mamoto and other leading companies. And we have a current small team. As soon as we will have the clearance, we will start the recruitment in order to start commercialization in 2026 under the assumption of getting the clearance, the grant letter.

Speaker 3

And then after the clearance, we will be able also to apply to AMA in order to move to CPT one. We have the support from about five society that we are going to support us for this application to move to CPT one. There is a process in place, which is twelve to eighteen months in order to get the approval, some kind of a survey that the AMA is doing, and then we will get the code and the reimbursement attached to it. And in parallel, we will work with the other society and some other payers.

Speaker 6

Great. Thank you.

Operator

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

Speaker 1

Thank you. So just to follow-up on the post market study. So that's been submitted and accepted by the FDA in terms of the submission has been accepted and now they're reviewing the protocol before making a final decision. Is that correct?

Speaker 3

Yes. We provided any information that they ask even including the intended use, the IFU, well as the indication they will require they require a patient leaflet with all the information. So everything in the package that's related to the post market study, to the recruitment plan, as well as all the package to build the the final the decision letter and grant letter, we provided all the required information. And they review them. We have a continuously discussions, and we are giving them information on anytime they ask.

Speaker 1

Okay. Great. So you've submitted everything. You're just waiting for them to either make a decision or see if they have any other information requests at this point.

Speaker 3

Yes. Okay. And leadership, which is extremely important, Anthony, that leadership that participated in the last two months or whatever, they still shown in any meeting that we have with them in order to be a positive decision. Leadership of the FDA, not for sure leadership of iSQ, but leadership of the FDA, management of FDA that participated in the last round and working closely with us in order to get this positive decision.

Speaker 1

Okay, great. And then just in terms of how iCure is preparing for the potential acceptance of the post market study and therefore FDA approval. I know you've already implemented some steps and hired a few people. Is there anything else that you feel iSecure needs to do to prepare to hit the ground running once the decision has been made?

Speaker 3

I think that after we had the meeting with the FDA and we already agreed with them on the indication for patients who are 70 years and over and they asked us to work on the post market study and we were able to announce it, it allowed us to to have a discussion with some breast surgeons and breast radiologists who like to participate to the study, but also to be a commercial site. I'm I'm not looking for sites just to join the study. In average, 400 patients to divide by 25 or 30, it's about 16 patients. All sites will be also a commercial site. So we've created a lot of traction of sites who are waiting for the FDA and they like to participate to be users and to be part of the study.

Speaker 3

So we're creating a lot of excitement about sites who we'd like to join, both breast cells and both radiologists. Even some of them we would like to start to be fully trained and to be a commercial user purchasing the console even before officially the study we start, so it's creating. And we will look, for for new team member that we will start to hire immediately after grant we will get the grant letter.

Speaker 1

So the sites have been selected. They will be both the sites that are part of the application for the post market study. They'll also be commercial sites and you're already starting to train the interventional radiologists and the breast surgeons, or you're lining them up to be trained immediately following anticipated approval, correct?

Speaker 3

Yes. They see it as a great opportunity to provide additional new data and to be a commercial user.

Speaker 1

And be a commercial user as well. That's great. Okay. And then just in terms of how are things progressing in Europe and just an update on the X Sense regulatory clearance in Israel?

Speaker 3

Europe, we are seeing again a lot of interest around breast. Even the coming, I think that I mentioned it, it's a public information. Mid September, we have the biggest, it's called CIRSA, interventional oncology and cardiovascular event. This is the biggest European event this time in Barcelona. And usually in this conference regarding interventional oncology, in the past, you saw a lot of publication presentations regarding kidney, lung, bone, liver, and other organs, mainly soft tissue ablation.

Speaker 3

Last year and mainly this year, the main topic and and all the opening ceremony running by professor Franco Olsing and some of our other users, it's it's all around breast. So interventional oncology conference become mainly around breast. So, this is creating around our many independent study in Europe and other places. So, become extremely important topic and we have the biggest real world data that's going to present in this coming conference. This is creating much more activities.

Speaker 1

Okay. So that conference in Barcelona, what's the date of that?

Speaker 3

September '17. Yes. And even later, in late September, we have the EOSOBI, which is the European conference for breast imaging, similar to the American FBI Society breast imaging. So both conference, the topic will be breast cancer and we have like seven to eight presentations of independent study. So, quite a lot of new information on this top important topic and this is this will drive utilization and additional new sales.

Speaker 1

Okay, great. So these conferences you expect to be able to drive new sales and utilization in Europe. Do you think that in addition to these conferences and the data that you have, do you think things will sales will accelerate in Europe following potential FDA approval? Do you think that will be an additional catalyst?

Speaker 2

Yes,

Speaker 3

absolutely. Same was, we had a very I personally participated to the Japanese Breast Cancer Society. We had an excellent conference led by Doctor. Fukuma and also Doctor. Richard Fine, who was the main PI of our study, past president of the American Society.

Speaker 3

So it was well accepted. And in Japan also, they are looking very much on the FDA and this will be extremely important catalyst for Terumo, but for the leadership of the Japanese society who would like to support us very much and also in other places. So even if you have a CE in breast cancer, everyone is looking on the FDA.

Speaker 1

Okay, great. Thanks so much for all that color. I'll hop back in the queue.

Speaker 5

Thank you.

Operator

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

Speaker 5

Hello. This is Eduardo on for Yi. Just maybe if I could ask a question regarding the seven year follow-up study you alluded to previously. Could you add a little more detail about the specific patient population in cancer type and how that, I think it was one percent recurrence rate you mentioned compares with the historical expectation for that those patients?

Speaker 3

Yes. The standard of care in Japan is a bit different from the from The US. In Japan, they are treating patients even from the age of 50 or basically officially, they don't have or they are not going to have age limitation in Japan. Firstly, the first peak in Japan for breast cancer, it's mainly for patients who are 45 to 49 and then the second peak is 65 and up. In Japan, they are giving all breast radiation to any patients.

Speaker 3

So, this is why they have excellent results of one percent recurrence, only one percent or ninety nine percent free from local recurrence. In the IHME study or even as part of standard of care, elderly patients, they are now with the de escalation. They try to omit radiation, for example, or or at least is not mandatory by by the societies. Even in the I three study, patients who got a cryoablation, adjuvant therapy, and radiation, we had zero recurrence. But most most part of our patients in the I3 study didn't get radiation and this is why we believe that this is part of why we got a ninety seven percent.

Speaker 3

We still have a very good result even to compare to the lumpectomy recurrence rate with the standard of care. But in Japan, they have better results. Hard for me to evaluate if whole breast radiation to any patient, it's a good or not good. But this is the difference between two standard of care.

Speaker 5

I see. So I guess more aggressive maintenance with the radiation in in Japan could be driving some

Speaker 1

of those different.

Speaker 3

From the tumor biology or or cancer grade, both Japan, US, and all the European or other independent study are goals for the same group of patients, low risk, early stage breast cancer, usually up to 1.5 centimeter from the tumor side. It's Luminal A. Luminal A, it's a low risk patient. So in Japan, I3 study, the PMS study for sure it will be according the indication and the European is the same group of patients. But Japan has, you could call it maybe a bit more precise or aggressive standard of care and this is why they have better high rates of free from local recurrence.

Speaker 5

Got it. That's helpful. And I guess, I'm curious in terms of the commercial launch strategy that you have, you're in the process of preparing the contingency of the FDA approval. Would you is your current cash position sufficient to fund those operations through FDA clearance? Or are you planning you might need a little bit more funding for that?

Speaker 3

Go on then.

Speaker 4

So currently we have enough funding to get the FDA authorization and pass that. Of course, when we will finalize the final costs of the and the budgeting of the expected post marketing study, we will understand our full cash demands and management will operate accordingly.

Speaker 5

Understood. All right. Thanks for answering the questions.

Operator

There are no further questions at this time. Eyal, would you like to make your concluding statement?

Speaker 3

Thank you, Yoni. Thanks for joining our call today and great questions. We are excited about what is ahead. Some key value driving milestones that we expect in the second half of the year include most importantly, a final FDA marketing authorization decision. Additionally, we expect our partner in Japan, Tirumo, to submit a regulatory filing in Japan for PROCENT in breast cancer.

Speaker 3

Also, regulatory front, we expect a response from the Israeli Ministry of Health on our next generation access. We have continued to get strong commercial and practitioners traction at the medical conferences where data from independent study of PROsense are presented. We expect more broad exposure at major conferences in September, including at the European Society of Breast Imaging at the Cardiological and Interventional Radiology Society of Europe, which I mentioned earlier, which is mid September. Additional data releases may be coming from independent study models on ICE three, including from trials in Italy and Brazil. Thanks and have a great day everyone.

Operator

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

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