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spk00: 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. I would now like to turn the conference over to Michael Poliview. Please go ahead.
spk04: Thank you, Yoni, and welcome to iSecure Medical's conference call to review the initial results for the 12 months ended December 31, 2023. 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 Medicals, CEO Eyal Shamir, CFO and COO Ronan Zimmerman, VP of Sales North America Shad Good, and Talit Buzi-Telzur, VP of Business Development and Global Marketing. Before we begin, I will now take a moment to read a statement about Overlook and 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, we will discuss the achievements we expect to accomplish as we continue to advance our growth strategies, our positioning to make significant commercial advances in key markets, pursuit of regulatory approvals in various jurisdictions, including with respect to the appeal we have filed requesting review of its de novo classification of ProSense, which earlier was granted, expansion of clinical applications release of results from our clinical results, potential market adoption, and future sales of IceCure's minimally invasive prior ablation technology, advancing regulatory and commercial strategies, strategic plans, and our belief that we are in position to meet our primary goals in 2024. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties in actual results, performance, or achievements of IceCure could differ materially from these described or implied by the statements during this call. The forward look at 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 factor section of the company's annual report on Form 20F for the year ended December 31, 2023, filed with the SEC earlier today, April 3, 2024, which is available on the SEC's website at www.sec.gov. The company disclaims any inattention or obligation, except as required by law, to update or revise any protocol statements, whether because of new information, future events, or otherwise. The conference call contains time-sensitive information and speaks only as of the live broadcast today, April 3, 2024. I will now turn the call over to iSecure Medical's CEO, Eyal Shamir. Eyal, please go ahead.
spk02: Thanks, Michael, and hello, everyone, and thank you for joining us today to review our 2023 year-end operating results, along with other key developments that have been achieved to date in 2024. The results were in line with our preliminary results we published in early January, and Ronen will review this during his prepared remarks. I will focus my remarks on the achievement to date in 2024 and the expectation over the coming quarters, which are anticipated to make this a pivotal and exciting time for ICU. As a culmination of 10 years of rigorous clinical study, our I3 trial for process for the treatment of early-stage low-risk breast cancer is now complete. Following a five-year follow-up, on our last patient. This is a significant achievement, and our knowledge is the first time a cryoablation without excision study for breast cancer has been completed, which seeks to provide the women with a safe, effective, minimally invasive treatment, redefining a women experience in early stage breast cancer. These timings, for instance, well with our FDA de novo fine request for marketing clearance for treating patients with early-stage low-risk breast cancer. We published the top-line result last month, demonstrating a 96.39% local recurrence free rate. Similar to the interim result we published in 2022 and validated by a numerous independent study performed by leading physicians globally. We are preparing the full data set and expect to submit the data along with the real-world data to the FDA also requested later this month. In conjunction with this filing, Data from the study will also present it at the upcoming American Society of Breast Surgeons annual meeting by leading breast surgeons in two separate sessions. As we wait the FDA decision, we are continuing to prepare our commercial readiness plan of process for early stage breast cancer in the U.S. We know there is a significant market need for an alternative to lumpectomy, one that benefits women and reduces costs for payers. We believe the breast cancer market represents a major value driver for our company, and to share our commercial plans is Shad Good, Vice President of Sales for North America, Shad's primary responsibility is to build out a self-infrastructure in anticipation of a broader commercialization of the company's processing system in the US and Canada. Shad, please go ahead.
spk05: Thanks, Eyal. I'll start off with a little bit about my background. I previously spent 18 years working in the breast cancer diagnostic and surgical space. Most recently, I've led the U.S. sales organization in the launch of an emerging technology, the wire-free device for lymphectomies. My goal today is to provide a brief overview of our commercial plan for ProSense. To begin, our U.S. commercial team currently includes four people, myself, two people in sales, and one clinical application specialist. Despite the limited sales footprint, we are having success as we continue to experience increased system sales and utilization. We also believe, upon the FDA's decision, we can achieve our initial post-launch sales goals with the current team. We have been very active with medical conferences and direct sales of ProSense for the indication for which it is already approved in the US. We've experienced strong interest in ProSense from breast surgeons and radiologists. However, we also believe rising patient awareness will generate greater interest and demand. Our goal over the next 90 to 120 days is to leverage the strengths of our current team while ensuring we are putting the pieces in place to support a larger sales team in anticipation of potential FDA clearance in early-stage breast cancer. That includes a phased approach to build out our sales organization, grow utilization with our existing install base, and expanding system sales with breast surgeons and radiologists. This go-to-market strategy includes working with medical societies to increase adoption through educational programs and hands-on training. If FDA clearance is granted, our aim is the eventual integration of persons into standard of care, as well as having appropriate reimbursement. We have a very clear reimbursement plan. At a recent Society of Interventional Oncologists Masterclass, breast cryoblation received high levels of attention and interest. Doctors travel from across the country to come to these sessions to learn about breast cryovolation. We believe that upon approval, many of these doctors will integrate ProSense into their practice. The published I3 study data is compelling. The groundwork has been laid, and we are ready to serve the market for early-stage breast cancer with our current sales, clinical, and distribution organization. I'll turn the call back over to Al. Thank you.
spk02: Thank you, Shad. Doctors in the U.S. are very aware of the use of and data coming from breast surgeons, interventional radiologists, and breast radiologists in Europe and Asia. Similarly, we expect potential FDA approval will have a very positive impact on global sense of process for early stage breast cancer. Clalit, who lead the global marketing effort, will provide some comments on our initiatives. Lalit, go ahead.
spk01: Thank you, Eyal. We believe the publication of the full data set from I3 and the FDA approval in early-stage low-risk breast cancer will be a major catalyst for increased commercial adoption globally, particularly in Europe, India, and Brazil. We remain very active at medical conference for a range of specialities, including breast surgeons, breast radiologists, interventional oncologists, and interventional radiologists. These conferences are featuring educational sessions about breast cancer cryoablation and are being conducted by key opinion leaders who are using ProSense. Furthermore, numerous independent studies have been presented on ProSense safety and efficacy in treating breast cancer. Beyond the major international conference, in each market we are collaborating with our distribution partners to engage the local medical community where the U.S. data is highly regarded and influential. The increase in product-driven revenues in 2023 was driven by our efforts in the United States as well as in other territories where we are growing our distribution networks, such as in Europe. We saw a marked increase in usage by interventional radiologists who comprise the majority of our customers in Europe and in Asia, in the treatment of other clinical applications such as kidney, bone, and soft tissue. Our distribution partners and a large audience of doctors are awaiting full data from the ASRI trial, which we expect to be a catalyst for accelerated growth to add breast cryoablation to the treatment they offer today. Internationally recognized medical societies are now offering breast cryoablation sessions to their scientific program at increasing rates. We believe this supports further adoption because in the countries where process is already approved for early stage breast cancer, we are experiencing continued increase in demand. I will now turn the call over to Ronen who will go over the financial results. Ronen.
spk07: Thank you, Lalit. In 2023, we were encouraged by the sales growth as we continue to transition from R&D to commercially focused company. For the 12 months ended December 31st, 2023, revenues from sales of process systems and disposable increased by 26% to $3 million, compared to $2.3 million for the 12 months ended December 31st, 2022. This increase was driven primarily by higher sales in the US and other territories. Total revenues for the 12 months ended December 31st, 2023, were $3.2 million, relatively flat compared to $3.1 million in the prior year, due to the increase in revenue from sales of systems and disposable, which was partially offset by the decrease in revenue recognition from the exclusive distribution rights agreement with the rumor corporation. Gross profit was $1.3 million for the 12 months ended December 31st, 2023, compared to $1.4 million for the 12 months ended December 31st, 2022. Gross margin was 40% in 2023 compared to 47% in 2022. The decrease in gross margin was primarily attributable to the decrease in revenue recognition from the Terumah Distribution Agreement, which was partially offset by sales increase of our systems and disposables. Non-GAAP gross profit and gross margin from the 12 months ended December 31st, 2023, which included process systems and disposable cryoprop cells, but did not include revenues from the Terumo agreement were $1 million and 35% respectively, compared to $0.7 million and 30% in 2022, an increase of approximately 47% in non-GAAP gross profit. Total operating expenses for 2023 narrowed to $16.9 million compared to $18.2 million for 2022. This was primarily attributable to reduction in R&D expenses and general and administrative expenses, which were partially offset by the increase in sales and marketing expenses. Net loss for 12 months ended December 31st, 2023, decreased by 14% to $14.7 million or $0.32 per share compared with the net loss of $17 million or $0.46 per share for the same period last year. As of December 31st, 2023, the company had cash and cash equivalents including short-term deposit of approximately $11.1 million Our initiative to manage our resources during the year achieved the desired effect and we lowered our monthly cash utilization without having to sacrifice our revenue generating all clinical efforts. During the first quarter, we raised approximately $3 million in gross proceeds from our ATM and ended the first quarter with cash and cash equivalents of approximately $11 million. I believe our continuing efforts to manage our cash and when combined with the prudent use of ATM, provide us with the resources to execute our clinical regulatory and commercial objective for 2024. Operator, we will now open the call for Q&A.
spk00: Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press star one. If you want to cancel from your request, please press star two. Please stand by while we poll for questions. The first question is from Kemp Dolliver of Brookline Capital Markets. Please go ahead.
spk03: Great. Thank you, and congratulations on the progress. First question is, given the ICE 3 trial had a U.S. footprint, What's the current installed base of ProSense such that those former trial sites in particular can start treating patients immediately upon approval?
spk02: Thank you, Kemp. This is Eyal, CEO. I will start and then... Shad will add some more information. We have our current install base for users who are treating mainly breast tumors. We have another site that we announced on catering in New York, very important, that dealing with endometriosis using our process system. Shad and his team uh will continue to grow the market uh in parallel for our uh process with the with the fda so we would like to be fully ready for that respect so if you have anything to add no way i don't have anything else to add to your comments
spk03: Great. And then my next question relates to the Xsense filing announced yesterday. And, you know, what are the features of the Xsense relative to ProSense?
spk02: Thank you. Process remains our primary system and we, along with our global partners, we are focusing on selling this system to penetrate a different market. When Accent is closer to becoming commercially available, we will have a developed strategy to reduce delays in the decision making. ProSense is our next generation liquid nitrogen single probe cryoablation system. We announced some top patents that we got around it. This is really a state-of-the-art latest technology and this is also set as a platform that will allow us the future product and pipeline for indication. So the recent filing request for clearance is for all of the indication of the process that we have at the moment, and we will have a proper transition commercial phase, but the excellence will open us potential future indication and future platform for different technologies.
spk03: Great, thank you.
spk00: The next question is from Yi Chen of HC Wainwright. Please go ahead.
spk06: Thank you for taking my questions. Could you comment on Once you submit the application, how quickly can FDA reach a decision? And once the approval is granted, how much, what is the estimated expenses for marketing the device in the U.S.? And how do you see the U.S. sales ramp-up may look like in 2025? Thank you.
spk02: Thank you, Yi. It's Eyal. You know, it remains unknown regarding timing since this is still a process from the initial and the novel application that we submitted in October 2022. It is very important that we not speculate on the timing. However, we believe that it could be any way from a few months to perhaps end of the year or very early in 2025. The FDA didn't open a new clock and it's still running under the timing of the original 510 denovo submission. Our goal is certainly to continue our continuous communication with the agency and to work and to prepare ourselves regardless the timing, which means to prepare the market and our infrastructure, as Shad mentioned. We are working on reimbursement, working with global KOLs and developing independent, non-sponsored trial for breast cancer. So we're going to have everything ready for getting the clearance. And after that, Shad will increase the team because we are anticipating much more demand. And we would like, of course, to increase the sales. We are not giving at the moment guidelines on production, but we are planning to grow the business importantly from 25 and on. Thank you.
spk00: If there are any additional questions, please press star 1. Please stand by while we poll for more questions. There are no further questions at this time. Mr. Eyal Shamir, would you like to make your concluding statement?
spk02: Thank you, everyone, for participating on our call today. Stay tuned for our I3 full data announcement, as well as other major developments. We sincerely thank all of the patients who participated in the I3 study and their families. We hope women who experience the process treatment are enjoying healthy life free of surgical scarring. We also are grateful to all our shareholders who support in helping to bring a much-needed minimally invasive solution to women with early-stage breast cancer. Thank you very much, everyone.
spk00: Thank you. This concludes the IceCure fourth quarter 2023 results conference call. Thank you for your participation. You may go ahead and disconnect.
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