CAESAREA, Israel, Aug. 14, 2023 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today reported financial results as of and for the six months ended June 30, 2023, as well as operational and recent corporate developments.
Second Quarter Highlights and Recent Achievements
"Our goal this year is to successfully transition from a development/clinical stage to a commercial stage company. I believe the regulatory clearances for ProSense in Canada and China demonstrate that we are well on our way to achieving our objective," stated IceCure Chief Executive Officer, Eyal Shamir. "We remain highly committed to this strategy and believe it will be significantly enhanced upon U.S. Food and Drug Administration (FDA) approval. The FDA review is continuing to progress and is consistent with the standard de novo review process. We remain highly engaged with the FDA and we look forward to its pending response. We are also implementing our go-to market strategy through greater market awareness and are working to increase reimbursement for ProSense procedures in order to make it accessible to those seeking a non-invasive alternative to a lumpectomy, today's standard of care."
Second Quarter of 2023 and Recent Operating Highlights
Financial Results as of and for the Six Months Ended June 30, 2023
For the six months ended June 30, 2023, the Company reported a 9% increase in revenues to $1.65 million compared to revenues of $1.5 million for the six months ended June 30, 2022. A 32% increase was reported for revenues from sales of systems and disposable probes for the six months ended June 30, 2023, which were $1.37 million compared to $1.03 million for the six months ended June 30, 2022, driven by higher sales in the United States, China, and other territories, partially offset by a decrease in sales in Europe. Revenue recognition from the exclusive distribution rights agreement in Japan with Terumo Corporation was $274 thousand compared to $484 thousand for the six months ended June 30, 2022.
Gross profit was $0.75 million for the six months ended June 30, 2023, compared to approximately $0.82 million for the six months ended June 30, 2022. Gross margin was 46% for the six months ended June 30, 2023, compared to 54% for the six months ended June 30, 2022. The decrease in gross profit and gross margin is primarily attributable to the decrease in revenue recognition from the Terumo distribution agreement.
Research and development expenses for the six months ended June 30, 2023, were $4.19 million compared to $4.65 million for the six months ended June 30, 2022. The decrease is primarily due to a reduction in development expenses of IceCure's next-generation single-probe system and a decrease in clinical and regulatory costs.
In anticipation of ramping up U.S. commercial efforts, sales and marketing expenses for the six months ended June 30, 2023, were $2.25 million, compared to $1.53 million for the six months ended June 30, 2022.
General and administrative expenses for the six months ended June 30, 2023, were $2.35 million, compared to $3.34 million for the six months ended June 30, 2022. The decrease is mainly due to a decrease in directors' and officers' insurance costs.
Total operating expenses for the six months ended June 30, 2023, were $8.79 million, compared to $9.52 million for the six months ended June 30, 2022. The decrease in operating expenses was primarily attributable to a reduction in research and development expenses and directors' and officers' insurance costs.
Net loss reported for the six months ended June 30, 2023, decreased to $7.66 million, or $0.17 per share, compared with a net loss of $8.97 million, or $0.24 per share, for the same period last year.
As of June 30, 2023, the Company had cash and cash equivalents, including short-term deposits, of approximately $16.7 million, compared to $23.66 million as of December 31, 2022.
Conference call & webcast info:
August 14, 2023, at 10:00 am ET
US: 1-888-642-5032
Israel/International: +972-3-9180610
A live webcast will be available at: https://veidan.activetrail.biz/IcecureQ2-2023
A recording of the webcast will be available for a limited time at: https://ir.icecure-medical.com/news-events/events-presentations
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal and Israeli 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, IceCure is using forward looking statement in this press release when it discusses: its goal to transition from a clinical stage to commercial stage company; and its looking forward to a response from the FDA as to the Company's ProSense de novo review process; and that Class III device clearance in Brazil for the Company's probes is expected by the end of Q1 2024.
Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release 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 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.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.
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Todd Kehrli
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ICECURE MEDICAL LTD. | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | ||||||||
As of | As of | |||||||
(Unaudited) | (Audited) | |||||||
U.S. dollars in thousands | ||||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | 3,031 | 23,659 | ||||||
Deposits | 13,648 | - | ||||||
Restricted deposit | 296 | 296 | ||||||
Trade accounts receivables | 118 | 78 | ||||||
Inventory | 2,751 | 2,857 | ||||||
Prepaid expenses and other receivables | 589 | 1,240 | ||||||
Total current assets | 20,433 | 28,130 | ||||||
NON-CURRENT ASSETS | ||||||||
Prepaid expenses and other long-term assets | 34 | 34 | ||||||
Right-of-use assets | 706 | 668 | ||||||
Property and equipment, net | 1,520 | 1,356 | ||||||
Total non-current assets | 2,260 | 2,058 | ||||||
TOTAL ASSETS | 22,693 | 30,188 | ||||||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
CURRENT LIABILITIES | ||||||||
Trade accounts payable | 652 | 714 | ||||||
Lease liabilities | 208 | 167 | ||||||
Other current liabilities | 2,995 | 3,455 | ||||||
Total current liabilities | 3,855 | 4,336 | ||||||
NON-CURRENT LIABILITIES | ||||||||
Long-term lease liabilities | 399 | 430 | ||||||
Total non-current liabilities | 399 | 430 | ||||||
SHAREHOLDERS' EQUITY | ||||||||
Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and | ||||||||
Additional paid-in capital | 101,505 | 100,831 | ||||||
Accumulated deficit | (83,066) | (75,409) | ||||||
Total shareholders' equity | 18,439 | 25,422 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 22,693 | 30,188 | ||||||
ICECURE MEDICAL LTD. | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) | ||||||||
Six months ended | ||||||||
2023 | 2022 | |||||||
U.S. dollars in thousands | ||||||||
Revenues | 1,647 | 1,512 | ||||||
Cost of revenues | 893 | 694 | ||||||
Gross profit | 754 | 818 | ||||||
Research and development expenses | 4,190 | 4,649 | ||||||
Sales and marketing expenses | 2,253 | 1,533 | ||||||
General and administrative expenses | 2,349 | 3,342 | ||||||
Operating loss | 8,038 | 8,706 | ||||||
Financial expenses (income), net | (381) | 262 | ||||||
Net loss and comprehensive loss | 7,657 | 8,968 | ||||||
Basic and diluted net loss per share | 0.168 | 0.244 | ||||||
Weighted average number of shares outstanding used in | 45,623,434 | 36,814,382 | ||||||
ICECURE MEDICAL LTD. | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) | ||||||||
Six months ended | ||||||||
2023 | 2022 | |||||||
U.S. dollars in thousands | ||||||||
Cash flows from operating activities | ||||||||
Net loss | (7,657) | (8,968) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation | 158 | 104 | ||||||
Share-based compensation | 674 | 885 | ||||||
Exchange rate changes in cash and cash equivalents and short-term deposits | 98 | 562 | ||||||
Changes in assets and liabilities: | ||||||||
Decrease (increase) in trade accounts receivables | (40) | 272 | ||||||
Decrease in prepaid expenses and other receivables | 651 | 1,287 | ||||||
Decrease (increase) in inventory | 106 | (696) | ||||||
Decrease in right of use assets | 62 | 95 | ||||||
Increase (decrease) in trade accounts payable | (62) | 56 | ||||||
Decrease in lease liabilities | (90) | (172) | ||||||
Increase (decrease) in other current liabilities | (460) | 279 | ||||||
Decrease in other long-term liabilities | - | (549) | ||||||
Net cash used in operating activities | (6,560) | (6,845) | ||||||
Cash flows from investing activities | ||||||||
Investment in short-term deposits | (13,648) | (4,277) | ||||||
Purchase of property and equipment | (322) | (493) | ||||||
Net cash used in investing activities | (13,970) | (4,770) | ||||||
Cash flows from financing activities | ||||||||
Exercise of pre-funded warrants | - | 1 | ||||||
Net cash provided by financing activities | - | 1 | ||||||
Increase (decrease) in cash and cash equivalents | (20,530) | (11,614) | ||||||
Cash and cash equivalents at beginning of the year | 23,659 | 25,621 | ||||||
Effect of exchange rate fluctuations on balances of cash and cash equivalents | (98) | (539) | ||||||
Cash and cash equivalents at end of period | 3,031 | 13,468 | ||||||
Non-cash activities | ||||||||
Obtaining a right-of-use asset in exchange for a lease liability | 100 | - | ||||||
| Last Trade: | US$0.60 |
| Daily Change: | -0.0078 -1.28 |
| Daily Volume: | 719,047 |
| Market Cap: | US$29.810M |
November 08, 2024 October 21, 2024 October 07, 2024 | |
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