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IceCure(ICCM) - 2025 Q2 - Earnings Call Transcript
2025-08-13 16:00
Financial Data and Key Metrics Changes - For the six months ended June 30, 2025, revenue was approximately $1.25 million, down from $1.75 million in the same period in 2024, reflecting a decrease of about 29% [12] - Gross profit for the first half of 2025 was $349,000 compared to $799,000 in the prior year, resulting in a gross margin of 28% versus 46% in 2024 [12] - Total operating expenses decreased to $7.39 million from $7.68 million a year ago, indicating efforts to optimize spending [13] - The 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 [13] Business Line Data and Key Metrics Changes - The company is experiencing a positive shift in adoption in Europe, particularly in breast cancer cryoablation, driven by clinical evidence and increased usage [8][9] - The ProSense technology was featured prominently at several high-impact medical forums, indicating growing interest and adoption [9] Market Data and Key Metrics Changes - The company believes there is a significant opportunity to change the paradigm of breast cancer care for an estimated 46,000 women in the U.S. annually [7] - The FDA has requested a post-market study to be conducted after marketing authorization, which the company is actively preparing for [8] Company Strategy and Development Direction - The company aims to strengthen its financial position and has successfully closed a $10 million rights offering, which was significantly oversubscribed [10] - The company plans to leverage upcoming medical conferences to drive awareness and adoption of its technology [16] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about receiving FDA approval before the end of 2025 and believes that this could accelerate the company's growth trajectory [4][10] - The company is preparing for commercialization efforts in 2026, contingent on receiving FDA clearance [25] Other Important Information - As of June 30, 2025, the company had $5.38 million in cash, cash equivalents, and short-term deposits, which included a $2 million loan from a major shareholder [14] - The company is actively working on a post-market study involving 400 patients across 30 sites, which is expected to conclude within three years [20] Q&A Session Summary Question: What is the nature of the additional information that FDA requested? - The FDA requested important information regarding the post-market study, including a list of potential participating sites and a recruitment plan [19] Question: Will the additional information lead to an increase in the budget for the trial? - The final budget will be decided once there is a full understanding with the FDA regarding all requests [21][23] Question: Are you still expecting late 2026 for CPT one code from AMA? - The company plans to start recruitment for commercialization as soon as clearance is received and will apply for CPT one code thereafter [25][26] Question: Has the submission for the post-market study been accepted by the FDA? - Yes, the submission has been accepted, and the FDA is currently reviewing the protocol [29][30] Question: Is the current cash position sufficient to fund operations through FDA clearance? - The company currently has enough funding to get through FDA authorization, but final costs will be assessed once the budgeting for the post-market study is finalized [51][52]
IceCure(ICCM) - 2025 Q1 - Earnings Call Transcript
2025-05-28 15:02
Financial Data and Key Metrics Changes - For the three months ended 03/31/2025, revenue was $725,000 compared to $743,000 for the same period in 2024, indicating a slight decrease [14] - Gross profit for the same period was $218,000, down from $269,000 year-over-year, with a gross margin of 30% compared to 36% in the previous year [14] - Net loss was $3,590,000 or $0.06 per share for Q1 2025, compared to a net loss of $3,610,000 or $0.08 per share for Q1 2024 [16] - As of 03/31/2025, cash equivalents were approximately $6,000,000, which increased to approximately $6,200,000 by 05/27/2025, including a $2,000,000 unsecured bridge loan [16] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by increased sales in North America and Europe, while sales in Asia declined [14] - North America saw an 11% year-over-year increase, and Europe experienced a 60% increase, while Asia saw a decline of about 60% [32] Market Data and Key Metrics Changes - The U.S. market has a demographic of approximately 46,000 patients annually for the treatment of early-stage low-risk breast cancer [7] - In Japan, there are over 100,000 new breast cancer cases annually, with a significant portion being low-risk early-stage cases [29] Company Strategy and Development Direction - The company is focused on obtaining FDA marketing authorization for ProSense, which is expected to be a first-in-class minimally invasive option for breast cancer treatment [10] - The company plans to expand its sales team significantly following FDA approval to enhance its market presence in the U.S. [41] - The company is preparing for potential regulatory filings and approvals in Japan and Israel as part of its growth strategy [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the post-market study plan, viewing it as a positive signal for future marketing authorization [8] - The company anticipates that the post-market study will drive further interest in ProSense and accelerate adoption once FDA approval is granted [45] Other Important Information - The company received a $2,000,000 unsecured bridge loan from its largest shareholder, providing additional flexibility while awaiting FDA decisions [12] - The company is preparing to apply for expanded reimbursement opportunities following FDA marketing authorization [27] Q&A Session Summary Question: Update on post-market study submission to the FDA - Management confirmed that the post-market study will require 400 patients across at least 25 sites, with no specific timeline for FDA response [21] Question: Details on the size of the post-market study package - Management indicated that the submission package was extensive, containing a lot of information [22] Question: Expected duration of the post-market study - Management believes the recruitment for the study should be completed within three years [23][25] Question: Potential for expanded reimbursement - Management stated that they plan to apply for a CPT one code after receiving marketing authorization, which would include physician fees [27][28] Question: Market size in Japan - Management noted that Japan has over 100,000 new breast cancer cases annually, with a significant portion being low-risk early-stage cases [29] Question: Geographic breakdown of revenue - North America saw an 11% increase, Europe a 60% increase, while Asia experienced a decline of about 60% [32] Question: Impact of tariffs on U.S. markets - Management acknowledged that tariffs have influenced operations, but specifics depend on future government decisions [40] Question: Plans for expanding the sales team post-approval - Management confirmed plans to expand the sales team significantly after receiving marketing authorization [41]