Earnings Call Transcript - ICCM Q2 2024

Operator, Operator

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 will be recorded. I would now like to turn the conference over 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 six months ended June 30, 2024, and provide an update on recent operational highlights. You may refer to the earnings release that we issued earlier this morning. Eyal Shamir, the company's CEO, is traveling and due to a last minute poor communication network in his location, is unable to dial in and participate. Therefore, joining today are IceCure Medical's VP of North American Sales, Shad Good; and the company's CFO and COO, Ronen Tsimerman. Before we begin, I'll now take a moment to read the statement about forward-looking statements. The call and the question-and-answer session that follows 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 the upcoming regulatory review process by the FDA in its medical device advisory panel, the expected timeline for reporting interim analysis of the ICESECRET kidney cancer trial, in the pursuit of regulatory approvals in various jurisdictions, including with respect to reimbursement codes for physician expenses and potential demand for market adoption of IceCure's minimally invasive cryoablation technology, advancing regulatory marketing and commercial strategies in our belief that we have resources to execute our clinical, regulatory and commercial objectives till the end of 2024 and into 2025. Because such statements yield future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of IceCure 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 December 31, 2023, filed with the SEC on April 3, 2024, 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 20, 2024. 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 IceCure Medical's VP of North American Sales, Shad Good. Shad, please go ahead.

Shad Good, VP of North American Sales

Thanks, Michael. Hello, everyone, and thank you for joining us today. As Michael mentioned, Eyal is unable to get on the call due to last minute network difficulties, so I will provide his business overview. During the first half of 2024, we continued to experience increased demand for ProSense as evidenced in the 20% year-over-year sales growth for ProSense systems and disposable probes sales as reported in our press release earlier today. While the growth is a positive indicator, we believe the level of enthusiasm, physician engagement and conversations at medical conferences specific to breast cancer and other indications, along with upcoming catalysts over the rest of 2024 and early 2025, may have a magnitude of greater positive impact on IceCure. Moreover, in December, we anticipate reporting an interim analysis of the ICESECRET kidney cancer trial. During the second quarter, the FDA informed us that it will convene a public medical device advisory panel later this year to obtain independent expert advice on scientific, technical and policy matters related to ProSense to help the FDA make a sound decision on regulatory approvals of ProSense in early-stage breast cancer. It's important to note that the current standard of care, lumpectomy, is a surgical procedure and is not regulated by the FDA. We believe the FDA's decision to convene the advisory panel demonstrates the extreme public health importance and, specifically, women's health importance of making a minimally invasive alternative to surgery available for women with early-stage low-risk breast cancer in the United States. As a reminder, ProSense is already available and approved to treat breast cancer in other global jurisdictions, and our objective is to ensure women in the US have the same access to the same care and realize similar benefits. Our team received numerous calls from women in the US and around the world who have recently been diagnosed with breast cancer, and they often ask for the nearest physician or hospital that uses ProSense. They are willing to travel, and in many instances will travel by plane because they want to have the choice of a minimally invasive treatment to avoid surgical excision. The wealth of evidence that has accumulated, including our ICE3 study and the growing number of independent studies, we believe makes the advantage of ProSense crystal clear for people participating in and watching the advisory panel discussion. The data from our study and third-party investigator-initiated studies have been consistently and overwhelmingly positive. In fact, we believe that the transparent and public forum will raise awareness of ProSense as a nonsurgical option and, therefore, support its rapid adoption in the United States, should the advisory panel recommend marketing authorization followed by FDA granting such authorization. Our US commercial sales team is prepared for the initial push. As a reminder, a reimbursement code for facility expense of $3,600 is already in place, with more reimbursement, including the physician expense expected to be applied for following marketing authorization. In our ICE3 study, the patient and doctor satisfaction rates were both 100%. Per the analysis at a five-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense cryoablation followed by hormone therapy were estimated to be free from local recurrence. This recurrence rate is similar to that of surgery, the current standard of care. We are confident that there will be a strong demand for cryoablation to treat early-stage low-risk breast cancer. In Europe, we continue to see excellent clinical results from independent studies investigating cryoablation of breast cancer among varying patient populations, including more advanced and metastatic breast cancer, and publications such as the British Journal of Radiology and the highly influential Medical Journal of Cancer. Promising clinical results were presented at the 32nd Annual Meeting of the Japanese Breast Cancer Society with the demand for minimally invasive breast cancer treatment being an overarching theme. Our team attended, and we were very pleased with the high level of interest in ProSense. Terumo, our distribution partner in Japan and also the largest medical device company in that country, plans to file for regulatory approval of ProSense for early-stage low-risk breast cancer with endocrine therapy in the first quarter of 2025. All of this data, as well as the data from clinical cases conducted globally, will be submitted to the FDA advisory committee panel. We believe that this will be a very positive factor in the panel's decision-making process. We believe our activities over the next several months will enhance our performance post FDA clearance. We are planning to be very visible at numerous medical conferences in the United States and in Europe, where we will be engaging with our target audience, including interventional radiologists, breast radiologists, and breast surgeons. Now I'm going to turn it over to Ronen to go over the numbers. Thank you.

Ronen Tsimerman, CFO and COO

Thank you, Shad. As Shad mentioned earlier, growth momentum continues for ProSense console and disposable cryoprobe sales. For the six months ended June 30, 2024, ProSense systems and disposable probes sales increased by 20% to $1.65 million compared to $1.37 million for the six months ended June 30, 2023. This was driven primarily by higher sales in Europe, the US, Japan, and other territories in Asia, partly offset by a decrease in sales in China. Total revenues, when including revenue recognition and other services from our Terumo agreement in Japan, grew by 6.5% to $1.75 million for the six months ended June 30, 2024, as compared to $1.65 million for the six months ended June 30, 2023, due to the increase in the sales of ProSense systems and disposables which was partially offset by a decrease in revenue recognition and other services in Japan of $100,000 and $274,000 in the first six months of 2024 and 2023, respectively. Gross profit for the six months ended June 30, 2024, grew by $799,000 compared to $754,000 for the same period in 2023. Gross margin remained consistent at 46% for the six months ended June 30, 2024, and for the six months ended June 30, 2023. Non-GAAP gross profit, which represents gross profit from sales of our products, not including revenue recognition for distribution agreements, increased by 46% for the six months ended June 30, 2024, to $699,000 compared to $480,000 for the same period last year. The non-GAAP gross margin for the six months ended June 30, 2024, grew to 42%, from 35% for the same period in 2023. Reconciliation of these non-GAAP figures is included in the earnings press release that we issued earlier today. Total operating expenses for the six months ended June 30, 2024, decreased to $7.68 million, compared to $8.8 million for the same period last year. The decrease is attributable mostly to a reduction in research and development and general and administrative expenses. Net loss narrowed during the six months ended June 30, 2024, to $6.7 million or $0.14 per share compared to a net loss of $7.66 million or $0.17 per share for the same period last year. As of June 30, 2024, the company had cash and cash equivalents of approximately $10.5 million and as of July 31, 2024, the company had cash and cash equivalents of approximately $10.3 million. During the first half of 2024, we raised $5.035 million in gross proceeds from the sales of ordinary shares under our ATM facility. The prudent management of cash has positioned us to execute major upcoming catalysts in the coming quarters including the FDA advisory panel expected in Q4 2024 and the FDA subsequent marketing clearance decision anticipated in the first quarter of 2025. Finally, I'd like to note that Eyal will be participating at H.C. Wainwright's Annual Global Investment Conference being held in New York from September 9 to 11. Additionally, Eyal will be participating at Lake Street's Annual Best Ideas Growth Conference also being held in New York on September 12, to provide an overview of the IceCure story and educate investors about the opportunities we are addressing with our novel ProSense technology.

Operator, Operator

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

Anthony Vendetti, Analyst

Thank you. Ronen, I was curious about the pipeline; I know your sales force is ready. If the advisory committee recommends FDA approval by early 2025, could you outline the planned rollout? Will you be starting with KOLs and the physicians you are collaborating with? Also, what is the commercialization plan beyond the KOLs in 2025?

Ronen Tsimerman, CFO and COO

So thank you, Anthony, for joining us for the questions, and I will refer to Shad.

Shad Good, VP of North American Sales

Yes, Anthony, I hope you can hear me well. Assuming we receive FDA approval, we have developed a detailed strategy for the next five years. This includes targeting specific societies, developing key opinion leaders, and establishing essential roles in the US to support our expected growth.

Anthony Vendetti, Analyst

And then in Japan, I know you're working with Terumo. Can you talk about the plan there? And the expectations there?

Ronen Tsimerman, CFO and COO

Yes. Yes, Anthony. So we are expecting that Terumo will file the request for PMDA approval in early 2025, in the first quarter. Of course, some of it will be based also on the ICE3 trial data that they have with them. So we're working very closely with them, our regulatory team with their regulatory and with KOLs over there in Japan.

Kemp Dolliver, Analyst

Great. Thank you. First, with regard to the first half, China was zero in the first half. And I'm curious why, if this is just a matter of the Shanghai Medtronic working through the inventory or just other factors behind the performance year-to-date?

Ronen Tsimerman, CFO and COO

Thank you, Kemp. China operates a bit differently from other regions, which comes with its own set of challenges. Sales can vary from quarter to quarter, so we can't provide specific guidance for China. However, we remain optimistic and believe we will be able to conduct business in China in the upcoming quarters.

Kemp Dolliver, Analyst

Okay. Thank you. The next question relates to the ICESECRET data and your plans and ability to leverage that data in the US in particular?

Ronen Tsimerman, CFO and COO

So currently, Kemp, we're focusing in the US mostly on breast and at least in the next year, this is what we're planning to focus on, but we're definitely utilizing this data for other territories in Europe, in Southeast Asia and also in South America. So it will definitely assist us.

Kemp Dolliver, Analyst

Okay, great. Thank you.

Ben Haynor, Analyst

Good day, gentlemen. Thank you for taking the questions. First one for me, just looking at some of these independent breast cancer studies, they are for slightly different patient populations and actually, it seems like in several cases, patients that are less well off than the ICE3 cohort was. Just kind of curious if you guys have any commentary on that? And what should investors take away from the potential for a broader applicability of ProSense?

Ronen Tsimerman, CFO and COO

Hi, Ben, and again, thank you for joining. So I think the most important thing is to understand that KOLs see the potential in our cryoablation activity and they choose their own set of groups in order to do independent studies. We look at it as a very good thing from our side. And we can see that the data is also very consistent and showing great promise. So we do encourage physicians to do their own studies, and of course, we can see all the papers and all the abstracts, which provide us with very important data for our next steps.

Ben Haynor, Analyst

Makes sense. That's helpful. And then maybe this is an unfair question. But I think you mentioned in the press release there is something like 15 ongoing independent studies being performed out there. Are there any specifically that you highlight for investors to take a look at? And I know it might not be necessarily your domain and with Eyal not on the call, but just curious if there are any that folks are paying attention to or should be?

Ronen Tsimerman, CFO and COO

So most of the studies are for breast, mostly breast cancer. If I remember correctly, about eight of the 15 are breast cancer. And again, we are very optimistic regarding the studies. And we're happy that so many KOLs are choosing our systems to do independent studies. We can't really provide more data than this because, again, it's an independent study we are not the sponsors. We do not decide when to submit a paper or when to submit an abstract to one of the conferences. But as soon as we have the data, as soon as we see it, we will, of course, release it to everyone. And, of course, as soon as the students themselves present it.

Ben Haynor, Analyst

Got it. That’s all I had. Congrats on the progress gentlemen, and good luck at the advisory committee.

Ronen Tsimerman, CFO and COO

Thank you very much.

Yi Chen, Analyst

Thank you for taking my question. Would you be able to comment on whether the advisory committee meeting will take place in early fourth quarter or towards the end of the year? And do you know how many members will be in the Advisory Committee and whether they will only review material submitted to the FDA?

Ronen Tsimerman, CFO and COO

Okay. Thank you, Yi. Thank you for joining and thank you for the questions. I'll refer the question to Shad.

Shad Good, VP of North American Sales

Yeah. I'll have to have you repeat the second part of the question. But to answer your first part of the question, we expect to receive the date for the meeting shortly. And once we receive that notification, we'll issue a press release announcing the details. Also, the FDA will make the meeting available, and we'll provide a webcast link for the event. And can you repeat the second part of the question?

Yi Chen, Analyst

How many members will be in the Advisory Committee and whether they will only review material submitted to the FDA?

Shad Good, VP of North American Sales

So we're expecting that we don't know the exact number of members who will be on the committee yet, but we're anticipating participation from breast surgeons, breast radiologists, oncologists, and regulatory experts on behalf of the FDA. Additionally, a lot of the clinical data available will be utilized to support our efforts during this event.

Yi Chen, Analyst

Okay. All right, thank you.

Operator, Operator

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

Ronen Tsimerman, CFO and COO

So we want to thank everyone for participating in today's call. We have achieved our goals through the first half of 2024, and for the remainder of 2024 and into early '25, we expect more data from independent studies on breast cancer and other indications. As soon as we have the details on the date and the public link for participation in the FDA advisory panel, we will share those with you through a press release. Thank you, everyone, for participating in our call today.

Operator, Operator

Thank you. This concludes the IceCure second quarter 2024 results conference call. Thank you for your participation. You may go ahead and disconnect.