5/18/2022

speaker
Operator
Conference Operator

Welcome to ICE Cures' first quarter 2022 results conference call. Management will provide an overview of ICE Cures' financial results as well as clinical and operational highlights. On the call today are ICE Cures' CEO, Eyal Shamir, and CFO, Ronen Zimmerman. They are joined today by Dr. Richard E. Fine. Dr. Fine is a trial investigator for ICE Cures' ICE-3 clinical trial on trioblation of small, low-risk breast cancer. Dr. Fine is also a past president and chairman of the American Society of Breast Surgeons, program director of the Breast Surgical Oncology Fellowship, and director of research and education at the West Comprehensive Breast Center in Germantown, Tennessee. Following the presentation, Ice Cures Management and Dr. Fine will be available for a question and answer session. I will now take a brief moment to read the safe harbor statement. This presentation 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 law. 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, ISCIR is using forward-looking statements in this presentation which it discusses pursuit of regulatory approval in FDA review strategic plans, commercial growth, expansion of clinical applications with its minimally invasive tribulation technology, advancing regulatory and commercial strategies, and expected quarter-over-quarter revenue variations for future periods. 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 those described in or implied by the statements in this presentation. The forward-looking statements contained or implied in this presentation 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 20F for the year ending December 31, 2021, filed with the FCC on April 1, 2022, which is available on the FCC's website at www.fcc.gov. The company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. I will now turn the call over to iSCURE CEO Eyal Shamir.

speaker
Eyal Shamir
CEO, IceCure Medical Limited

Hello everyone and thanks for joining our first quarter 2022 call today. We will start with a review of our significant business development since the beginning of the year. Then I will turn the call over to Ronen for an overview of the financial results. We will then turn the call over to Dr. Richard Fein. We are grateful to him for sharing his time with us today. Dr. Fein is an investigator of our I3 clinical trial who uses ProSense with his patients. He can provide valuable insight on process and how it can potentially optimize treatment in a low risk and early stage breast cancer. On the commercial front, we started the year strong due in large part of the reopening of post-pandemic travel, making in-person business and clinical visits a reality again. Several new process systems were installed with our global customer base. I will remind listeners that process is approved for various indications in 14 countries. We have a commercial presence in 20 countries, including the U.S. We have CPT-1 code for coverage of cryoablation procedures as well. such as kidney, liver, lung, and bone cancer, fibroadenoma, which is the nine breast tumors. We have also CPT-3 code for breast cancer. We have resumed in-person practitioner site visits and have been conducting hands-on demos and training sessions. Our business development team is now more effectively able to pursue and close on cells opportunity. We are happy to report that our cells in the U.S. increased in Q1. Process was extremely well received at three very important oncology conferences in the U.S. and Europe. Though two data presentations and on demos and symposia. we have generated a great deal of excitement for process. Notably, at the 23rd Annual Meeting of the American Society of Breast Surgeons in April, iSKILL publication regarding our i3 Breast Cancer Cryoablation Study Interim Results, originally published in the scientific journal, The Annals of Surgical Oncology, was chosen as one of the best papers of 2021 from thousands of breast cancer articles published annually. Dr. Ellen Pass, the past president of the American Society of Breast Surgeons, presented the paper as part of an annual address at the conference. The American Society of Breast Surgeons is a highly regarded and influential organization that sets the treatment guidelines, and standard of care for breast cancer in the U.S. These presentations of our study is very significant in our view, and it's point to the potential improvement persons can deliver in the standard of care in a low-risk, early-stage breast cancer. Dr. Pass' presentation was made to a large audience of breast surgeons and related medical professionals who were attending to the conference in person and online. During the second quarter, we continued to work towards U.S. FDA approval for process in early stage breast cancer. We had previously filed our press submission package with the FDA in the end of November of last year. In our final submission, we plan to suggest a novel classification including requests for a spring discussion under the FDA procedure. The proposed intended use is for early-stage breast cancer patients at high risk for surgery. Our continued discussions with the FDA is part of our breakthrough device designation we were granted last year. Our published I3 interim trial results in this indication show clear benefit, including that almost 98% of the patients who received the PROSEN system cryoablation treatment are recurrence-free, with 76 patients having reached five years post-treatment. 98% of the doctors and 95% of the patients reported satisfactions with the cosmetic results. I will now turn the call over Ronen for the financials.

speaker
Ronen Zimmerman
CFO, IceCure Medical Limited

Thank you, Eyal. iSCURE has successfully transitioned into a commercial stage company while continuing our innovative clinical and R&D work. Our quarter-over-quarter revenues vary, and we expect this to continue into the foreseeable future due to revenue recognition from international distribution agreements as well as viability in sales. For the three months ended March 31st, 2022, revenue decreased by 48% to approximately $750,000 compared to $1.4 million in the first quarter of the last year. The decrease is due to decreased revenue recognition of approximately $400,000 from the distribution agreements with the rumor for the commercialization of procents to treat malignant breast tumors in Japan, Singapore, and Thailand, and a decrease in sales in the Asia region, which is impacted by COVID searches and associated restrictions on commercial activity. These decreases were partially offset by an increase in sales in the USA, Gross profit was approximately $440 for the three months ended March 31st, 2022, compared to approximately $940 million for the same period in 2021. Gross margin was approximately 58% for the three months period ended March 31st, 2022, compared to approximately 65% for the first quarter of 2021. The decrease in gross margin is mostly attributable to the decrease in revenue recognition from the payroll distribution agreements. Research and development expenses for the three months ended March 31st, 2022 were $2.4 million compared to $1.1 million for the period last year. The increase is attributed to the acceleration in the development of iSCU's next-generation single-probe system and clinical and regulatory activities. Selling, marketing, general and administrative expenses in aggregate for the three months ended March 31st, 2022 were $2.5 million compared to approximately $1 million for the first quarter of 2021. The increase is attributed to the company's expanding commercialization efforts and to the increased Mustang listing related expenses. Total operating expenses for the three months ended March 31st, 2022 were approximately $4.9 million compared to $2.1 million for the same period last year. The increase in operating expenses is attributable to increased development, commercialization, and NASDAQ listing related activities. As a result of lower revenue and increased operation activities, Net loss reported for the three-month period ended March 31, 2022 increased to approximately $4.4 million or $0.12 per share compared with the net loss of approximately $1.4 million or $0.07 per share for the same period last year. As of March 31, 2022, the company had cash and cash equivalents of approximately $22.4 million compared with approximately $25.6 million as of December 31st, 2021. I will now turn the call over to Dr. Fine. Dr. Fine has been a breast surgeon since 1988 and has served as a board member or trustee in organizations including the National Consortium of Breast Centers, the National Accreditation of Breast Centers Program, and the American Cancer Society. Dr. Fine was the president of the American Society of Breast Surgeons in 2003-2004 and chairman of the board there from 2015 to 2018. Thank you.

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