IceCure Medical Ltd (ICCM) Q2 2025 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. Good morning, and thank you for standing by. [Operator Instructions] Please be advised that today's conference call is being recorded. I would now like to hand over the call to Michael Polyviou. Please go ahead.

Thank you, Joni, and welcome to IceCure Medical's conference call to review the financial results as of and for the 6 months ended June 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 IceCure Medical's CEO, Eyal Shamir; and the company's CFO and COO, 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 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. 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 ProSense 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 a 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 to vary quarter-to-quarter as the company focuses on building commercial sales -- commercial scale sales, 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 & Co Conference, participation in Maxim Group LLC's Conference and the belief that the company's cash, cash equivalents and short-term deposits position in a -- strong financial position to continue executing across regulatory, clinical and commercial initiatives. 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 December 31, '24, filed with the Securities and Exchange Commission on March 27, 2025, which 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, August 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 IceCure Medical's CEO, Eyal Shamir. Eyal, please go ahead.

Thanks, Michael, and hello, everyone, and thank you for joining us today to review our results for the first half of 2025. This is a pivotal time for IceCure 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 ProSense for the very important indication of early-stage low-risk breast cancer in women aged 70 and over combined with adjuvant endocrine therapy. We believe that this is a significant opportunity to change the paradigm of breast cancer care for the estimated of 46,000 women in the U.S. annually with the alternative to lumpectomy. In the second quarter, we concluded the productive meeting with leadership at the FDA Center for 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. 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 finds 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. While ProSense is already approved in Europe for several indication included breast cancer, we believe the increase in usage for breast cancer is being driven by the ICE3 results and the growing body of independent clinical evidence. We were of 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. ProSense 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 ProSense 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 91% of patients would choose ablation over breast conserving surgery. Earlier in this quarter, ProSense was featured at the Japanese Breast Cancer Society Conference which during the conference, a respected expert and ProSense user Professor Fukuma presented 17 years of data from over 600 breast cancer patients showing a 99% recurrence-free rate with cryoablation. I would like to repeat this message of this amazing follow-up and results. 17 year of follow-up for over 600 breast cancer patients showing only 1% recurrence, which means 99% 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 million rights offering that was significantly oversubscribed. We believe that this is a strong indicator and a vote of confidence from our shareholders. We expect this to provide a sufficient cash run rate for the anticipated FDA marketing authorization decision. Our largest shareholder and a Board member, Mr. Li Haixiang of Epoch Partner Investment Limited participated in the rights offering. I will now turn the call over to Ronen.

Thank you, Eyal. For the 6 months ended June 30, 2025, revenue was $1.25 million compared to $1.75 million for the same period in 2024. As previously disclosed, over $200,000 in product shipments originally scheduled for Q2 were delayed due to the Israel-Iran conflict in June. This will be recognized in the third quarter. Gross profit for the first half of was $349,000 compared to $799,000 in the prior year period. This resulted in gross margin of 28% versus 46% in the first half of 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 $7.39 million for the 6 months period compared to $7.68 million a year ago. This reflects our efforts to optimize spending without sacrificing commercial or regulatory execution. Net loss for the first half of 2025 was $6.95 million or $0.12 per share compared to a net loss of $6.69 million or $0.14 per share in the same period last year. As of June 30, 2025, we had $5.38 million in cash, cash equivalents and short-term deposits, which included a $2 million loan from our major shareholder. This excludes the $10 million in gross proceeds raised from our rights offering, which closed at August 1, 2025. During the first half of 2025 ICE raised $2.65 million in net proceeds from the sales of 2,127, 961 ordinary shares under our 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 IceCure story and broaden investor engagement. Eyal and I will be presenting at the next month's H.C. Wainwright conference, and we'll be participating at Maxim Conference in October. Operator, we will now open the call for Q&A.

[Operator Instructions] The first question is from Kemp Dolliver of Brookline Capital Markets.

Good day. What's the nature of the additional information that FDA requested?

Good morning, and thank you for your questions. This is Eyal, the CEO. The FDA would like to get a quite important information around the post-market study. As we announced it's supposed to be after granting the approval, it's going to be 400 patients in 30 sites, and we need to conclude the participation of the patient, recruitment of the patients within 3 years. So they would like to get some list of potential participating sites, some kind of qualification form of the site and to see the recruitment plan that we will be able to conclude and to run the post-market study after they will grant letter. So to build the confidence and the information that IceCure 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.

And I mean just 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?

We are working now to update the budget. Maybe Ronen could give some more light on it. But we work with the site. Of course, we need to have some support like any study from CRO and basically, it's a normal post-market study. And we have also the current CPT3 code 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 the study.

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.

Great. And then a question on a separate topic, and that is given the expected timetable for an approval, are you still expecting, for instance, late '26 for CPT1 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?

I will start from the last part of your questions. As soon as we will get the clearance, we have Mr. Shad Good our VP sales for North America who is bringing over 20 years of experience in breast field from J&J, Mammotome 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 and then after the clearance, we will be able also to apply to AMA in order to move to CPT1. We have support from about 5 society that we are -- going to support us for this application to move to CPT1. There is a process in place, which is 12 to 18 months, in order to get the approval, some kind of a survey that 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.

The next question is from Anthony Vendetti of Maxim Group.

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?

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

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.

And leadership, which is extremely important, Anthony, that leadership that participated in the last 2 months or whatever. They're 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 IceCure, 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.

Okay. Great. And then just in terms of how IceCure 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 IceCure needs to do to prepare to hit the ground running once the decision has been made?

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 ask us to work on the post-market study, and we were able to announce it. It allowed us 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 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 it could be part of the study. So it's creating a lot of excitement about sites who we'd like to done, both breast surgeons, 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 new team members that we will start to hire immediately after grant -- we will get the grant letter.

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?

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

And be 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 expense regulatory clearance in Israel.

Europe, we are seeing, again, a lot of interest around breast. Even the coming -- I think that I mentioned it with the public information, mid-September we have the biggest, it's called CIRSE, it's 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. Last year and mainly this year, the main topic and all the opening ceremony running by Professor Franco and some of our other users, it's all around breast. So interventional oncology conference become mainly around breast, this is creating around our many independent studies in Europe and other places. So breast become extremely important topic, and we have the biggest real-world data that's going to present in this coming conference. So this is creating much more activities.

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

September 13 to 17. Yes. And even later, late -- in late September, we have the EUSOBI, which is the European conference for breast imaging, similar to the American SBI, Society Breast Imaging. So both conference, the topic will be breast cancer, and we have like 7 to 8 presentations of independent study. So quite a lot of new information on this important topic. And this will drive utilization and additional new sales.

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?

Yes. Yes. Absolutely. Same word. We had a very -- I personally participated to the Japanese Breast Cancer Society. We had an excellent conference led by Dr. Fukuma and also Dr. Richard Fine, who was the main PI of our study, past President of the American Society. 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.

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

This is Eduardo on for Yi. Just maybe if I could ask a question regarding the 7-year follow-up study you alluded to previously. Could you add a little more detail about the specific patient population and cancer type and how that -- I think it was 1% recurrence rate you mentioned, compares with the historical expectation for those patients?

Yes. The standard of care in Japan is a bit different from the U.S. 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. So this is why they have excellent results of a 1% recurrence, only 1% or 99% free from local recurrence. In the ICE3 study or even as part of standard of care, especially elderly patients, they are now with the deescalation, they try to omit radiation, for example, or at least is not mandatory by the societies. Even in the ICE3 study, patients who got a cryoablation adjuvant therapy and radiation, we had a 0 recurrence, but most part of our patients in the ICE3 study didn't get radiation, and this is why we believe that this is part of why we got 97%. We still have a very good results even to compare to the lumpectomy recurrence rates 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 good or not good. but this is the difference between 2 standard of care.

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

From the tumor biology or cancer grade, both Japan, U.S. 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 centimeters from the tumor site. It's called Luminal A. Luminal A, it's a low-risk patients. So in Japan, ICE3 study, the PMS study, for sure it will be according to 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 recurrences.

Got it. That's helpful. And I guess I'm curious in terms of the commercial launch strategy that you have and 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?

Ronen?

So currently, we have enough funding to get the FDA authorization and past 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.

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

Thank you, Joni. 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, Terumo to submit a regulatory finding in Japan for ProSense in breast cancer. Also, on 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 and the Cardiological and Interventional Radiology Society of Europe, which I mentioned earlier, CIRSE, which is the mid-September. Additional data releases may be coming from independent study models on ICE3, including from trials in Italy and Brazil. Thanks, and have a great day, everyone.

This concludes the IceCure Second Quarter 2025 Results Conference Call. Thank you for your participation. You may go ahead and disconnect.