IceCure(US:ICCM)2022-08-16 05:40Financial Data and Key Metrics Changes - For the six months ended June 30, 2022, revenue decreased by 27% to $1.5 million, compared to $2.1 million in the first half of last year, primarily due to reduced revenue recognition from distribution agreements and decreased sales in Asia due to COVID-19 impacts [24][30] - Gross profit was approximately $800,000 with a gross margin of approximately 54%, down from approximately $1.2 million and 58% respectively in the same period of 2021 [26] - Net loss increased to approximately $9 million or $0.24 per share, compared to a net loss of approximately $3.8 million or $0.16 per share for the same period last year [30] Business Line Data and Key Metrics Changes - The company signed an exclusive distribution agreement in Mainland China for IceSense3, with a minimum purchase target of $3.5 million over the first three years [10][13] - ProSense systems were sold and installed in several clinics worldwide, including the U.S., Turkey, and Poland, with expectations for increased installations based on commercial interest [15][16] Market Data and Key Metrics Changes - The healthcare market in China is expected to reach $2.3 trillion by 2030, driven by government investments in healthcare infrastructure [12] - The company is actively expanding its regulatory landscape, with applications filed in Brazil and Canada for the ProSense system [17][18] Company Strategy and Development Direction - The company aims to expand its regulatory and commercial strategies, focusing on the adoption of its minimally-invasive cryoablation technology [5][21] - Management highlighted the importance of the distribution agreement with Medtronic as a strategic milestone for market penetration in China [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future revenue growth driven by increased installations and sales of ProSense systems [21] - The management team is focused on advancing regulatory approvals and expanding clinical applications, with expectations for revenue recognition from the new distribution agreement in the second half of 2022 [14][21] Other Important Information - The company participated in 10 conferences and events during the second quarter, showcasing its technology and gaining traction within the medical community [19][20] - The ICE3 clinical trial is expected to provide final results by the end of 2023 or early 2024, which could further validate the technology [34] Q&A Session Summary Question: Can you share updated patient follow-up data from the trial? - By June 2022, 82 patients had completed the trial with follow-ups of up to five years, with a local recurrence rate of 2.06% [75][78] Question: Is this a reasonable run rate to think about for the full year? - The company believes that spending levels will remain consistent with the first half of the year, indicating a flexible budget to accommodate necessary changes [81] Question: What are the differences in breast cancer patients seen by the company versus breast surgeons? - The patients seen are largely the same, with collaboration between the company and breast surgeons in the ICE3 trial [82] Question: What is the regulatory strategy for FDA submissions? - The first indication planned for submission is for low-risk early-stage T1 invasive breast cancer, based on interim results [85]