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IceCure(ICCM) - 2022 Q4 - Annual Report
2022-12-05 12:33
Exhibit 99.1 "We have edged closer to commercialization of ProSense for breast cancer in the U.S. with our recent FDA filing for marketing approval, and the assignment of a Medicare CPT III reimbursement code. IceCure has taken a leadership role in the industry based on our vast ICE 3 breast cancer cryoablation clinical data and by receiving the CMS's first payment assignment for cryoablation of breast cancer," stated IceCure's CEO Eyal Shamir. "While our quarterly revenues may continue to fluctuate in the ...
IceCure(ICCM) - 2022 Q2 - Quarterly Report
2022-09-22 20:05
Financial Statements This section presents the company's unaudited interim condensed consolidated financial statements, including the balance sheet, statements of comprehensive loss, changes in shareholders' equity, cash flows, and accompanying notes [Unaudited Interim Condensed Consolidated Balance Sheet](index=1&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Balance%20Sheet) As of June 30, 2022, IceCure Medical's total assets decreased to **$23.8 million** from **$32.3 million**, primarily due to a reduction in cash and cash equivalents, leading to a decline in total shareholders' equity from **$27.0 million** to **$18.9 million** Balance Sheet Summary | Financial Metric | June 30, 2022 ($ thousands) | December 31, 2021 ($ thousands) | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | 13,468 | 25,621 | -47.4% | | Total current assets | 21,563 | 30,322 | -28.9% | | Total Assets | 23,813 | 32,281 | -26.2% | | Total Liabilities | 4,937 | 5,323 | -7.2% | | Total Shareholders' Equity | 18,876 | 26,958 | -30.0% | - The company's cash position more than halved in the first six months of 2022, decreasing from **$25.6 million to $13.5 million**[3](index=3&type=chunk) - The accumulated deficit increased from **$58.4 million to $67.4 million** during the first half of 2022, contributing to the decline in shareholders' equity[3](index=3&type=chunk) [Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss](index=2&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) For the six months ended June 30, 2022, the company reported a net loss of **$9.0 million**, a significant increase from **$3.8 million** in 2021, driven by a **27% revenue decrease** and substantial rises in R&D and S&M expenses Statements of Comprehensive Loss Summary | Metric | Six months ended June 30, 2022 ($ thousands) | Six months ended June 30, 2021 ($ thousands) | Year-over-Year Change | | :--- | :--- | :--- | :--- | | Revenues | 1,512 | 2,073 | -27.1% | | Gross Profit | 818 | 1,193 | -31.4% | | Research and development expenses | 4,649 | 2,730 | +70.3% | | Sales and marketing expenses | 1,533 | 625 | +145.3% | | Operating loss | 8,706 | 3,746 | +132.4% | | Net loss | 8,968 | 3,847 | +133.1% | | Basic and diluted net loss per share | $0.244 | $0.156 | +56.4% | [Unaudited Interim Condensed Consolidated Statements of Changes in Shareholders' Equity](index=3&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity) Shareholders' equity decreased by **$8.1 million** to **$18.9 million** by June 30, 2022, primarily due to a **$9.0 million net loss**, partially offset by **$0.9 million** in share-based compensation Statements of Changes in Shareholders' Equity Summary | Description | Amount ($ thousands) | | :--- | :--- | | Balance as of January 1, 2022 | 26,958 | | Share-based compensation | 885 | | Pre-funded warrants exercised | 1 | | Net loss for the period | (8,968) | | **Balance as of June 30, 2022** | **18,876** | [Unaudited Interim Condensed Consolidated Statements of Cash Flows](index=4&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash and cash equivalents decreased by **$12.1 million** to **$13.5 million** in H1 2022, driven by **$6.8 million** used in operating activities and **$4.8 million** in investing activities, contrasting with a **$15.2 million** increase in H1 2021 Statements of Cash Flows Summary | Cash Flow Activity ($ thousands) | Six months ended June 30, 2022 | Six months ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | (6,845) | (3,561) | | Net cash provided by (used in) investing activities | (4,770) | 4,079 | | Net cash provided by financing activities | 1 | 14,642 | | **Increase (decrease) in cash and cash equivalents** | **(11,614)** | **15,160** | - Cash used in operations nearly doubled year-over-year, reflecting the larger net loss and changes in working capital[10](index=10&type=chunk) - Financing activities provided virtually no cash in H1 2022, compared to **$14.6 million** raised from share issuance in H1 2021[10](index=10&type=chunk) [Notes to the Unaudited Interim Condensed Consolidated Financial Statements](index=5&type=section&id=Notes%20to%20the%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) This section provides supplemental details on the company's operations, accounting policies, financial condition, including its cryoablation business, going concern assessment, revenue breakdown, and subsequent events [Note 1 - General](index=5&type=section&id=Note%201%20-%20General) This note describes IceCure Medical's business as a developer of cryoablation devices, its global operations, and management's assessment of its going concern status - IceCure Medical is an Israeli company, listed on NASDAQ and the Tel Aviv Stock Exchange, that develops and commercializes minimally invasive cryoablation devices for freezing tumors[12](index=12&type=chunk)[13](index=13&type=chunk)[14](index=14&type=chunk) - The company has subsidiaries and operations in the United States, Hong Kong, and China to manage business development, clinical trials, and regulatory approvals in those regions[14](index=14&type=chunk)[15](index=15&type=chunk) - Regarding its 'Going Concern' status, the company has an accumulated deficit of **$67.4 million** and generated a loss of **$9.0 million** in H1 2022; however, management expects its cash reserves of **$15.4 million** as of August 31, 2022, to be sufficient for the next 12 months of operations[17](index=17&type=chunk)[18](index=18&type=chunk)[19](index=19&type=chunk) [Note 2 - Summary of Significant Accounting Policies](index=6&type=section&id=Note%202%20-%20Summary%20of%20Significant%20Accounting%20Policies) This note confirms that the interim financial statements adhere to U.S. GAAP and apply accounting policies consistent with the latest annual statements - The unaudited interim financial statements are prepared in accordance with U.S. Generally Accepted Accounting Principles (U.S. GAAP)[22](index=22&type=chunk) - The significant accounting policies applied are identical to those used in the company's latest annual financial statements[24](index=24&type=chunk) [Note 4 - Revenues](index=7&type=section&id=Note%204%20-%20Revenues) This note details the company's revenue sources, primarily from the sale of consoles, disposables, and exclusive distribution agreements - The company's revenues are primarily derived from the sale of consoles, disposables, and exclusive distribution agreements[29](index=29&type=chunk) Revenue Sources | Revenue Source ($ thousands) | Six months ended June 30, 2022 | Six months ended June 30, 2021 | | :--- | :--- | :--- | | Consoles | 361 | 695 | | Disposables | 667 | 556 | | Exclusive distribution agreement | 484 | 822 | | **Total** | **1,512** | **2,073** | [Note 5 - Subsequent Events](index=7&type=section&id=Note%205%20-%20Subsequent%20Events) This note outlines significant events occurring after the reporting period, including the granting of options and issuance of restricted shares to consultants - On July 4, 2022, the company granted **55,222 options** to a consultant at an exercise price of approximately **$1.76 per share**[32](index=32&type=chunk) - On July 18, 2022, the company issued **21,000 restricted ordinary shares** to a consultant, which are restricted from sale for 12 months[32](index=32&type=chunk)
IceCure(ICCM) - 2022 Q2 - Earnings Call Transcript
2022-08-16 05:40
Financial 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]
IceCure(ICCM) - 2022 Q1 - Earnings Call Transcript
2022-05-18 18:06
Financial Data and Key Metrics Changes - Revenue for Q1 2022 decreased by 48% to approximately $0.75 million compared to $1.4 million in Q1 2021, primarily due to decreased revenue recognition from the distribution agreement with Terumo and a decline in sales in the Asia region impacted by COVID surges [17][24] - Gross profit was approximately $0.44 million for Q1 2022, down from approximately $0.94 million in the same period last year, with a gross margin of approximately 58% compared to 65% in Q1 2021 [18] - Net loss for Q1 2022 increased to approximately $4.4 million, or $0.12 per share, compared to a net loss of approximately $1.4 million, or $0.07 per share, for the same period last year [24] Business Line Data and Key Metrics Changes - Sales in the U.S. increased in Q1 2022, with ProSense receiving positive feedback at major oncology conferences [9] - The company has installed several new ProSense systems globally, indicating a strong commercial presence in 20 countries [7][8] Market Data and Key Metrics Changes - The decrease in revenue recognition from the Terumo distribution agreement was a significant factor in the overall revenue decline, particularly affecting markets in Japan, Singapore, and Thailand [17][66] - The company expects to have probe approval in China by September or October 2022, despite COVID-related delays [41] Company Strategy and Development Direction - The company is focused on obtaining FDA approval for ProSense in early-stage breast cancer, with plans for a De Novo classification and a sprint discussion with the FDA [13][38] - IceCure aims to expand its commercialization efforts and enhance its clinical applications with its cryoablation technology [3][16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future revenue growth due to international distribution agreements and increased sales efforts [16] - The company is working closely with the FDA and expects to finalize its submission for early-stage breast cancer treatment by early 2024 [59] Other Important Information - Research and development expenses increased to $2.4 million in Q1 2022, attributed to the acceleration of the next-generation single-probe system development [19][20] - Selling, marketing, general, and administrative expenses rose to $2.5 million, reflecting the company's expanding commercialization efforts [22] Q&A Session Summary Question: Update on FDA submission and timeline - Management confirmed ongoing discussions with the FDA and plans to submit for clearance for cryoablation of early-stage breast cancer operations who are high risk for surgery [36][38] Question: Impact of COVID on NMPA clearance in China - Management expects probe approval by September or October 2022, with minimal delays anticipated due to COVID lockdowns [41] Question: Operating expenses outlook - Operating expenses are expected to remain at current levels due to accelerated R&D efforts [42][43] Question: Receptiveness to cryoablation among colleagues - There is significant excitement and recognition of cryoablation as a viable alternative to surgery among medical professionals [45][48] Question: Timeline for registry implementation - The goal is to start the registry towards the end of summer or beginning of fall 2022 [73] Question: Ongoing NASDAQ listing costs - Management indicated that NASDAQ-related costs are expected to remain elevated due to rising insurance costs [74]
IceCure(ICCM) - 2021 Q4 - Annual Report
2022-04-01 10:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANTTO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission ...