Full Press Release Details
ICECURE MEDICAL LTD.
UNAUDITED INTERIM CONDENSED CONSOLIDATED
(U.S. dollars in thousands, except share
data and per share data)
| As of June 30, | As of December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | 13,468 | 25,621 | ||||||
| Deposit | 4,257 | - | ||||||
| Trade accounts receivable | 184 | 456 | ||||||
| Inventory | 2,651 | 1,955 | ||||||
| Prepaid expenses and other receivables | 1,003 | 2,290 | ||||||
| Total current assets | 21,563 | 30,322 | ||||||
| NON-CURRENT ASSETS | ||||||||
| Prepaid expenses and other long-term assets | 330 | 333 | ||||||
| Right of use assets | 818 | 913 | ||||||
| Property and equipment, net | 1,102 | 713 | ||||||
| Total non-current assets | 2,250 | 1,959 | ||||||
| TOTAL ASSETS | 23,813 | 32,281 | ||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Trade accounts payable | 937 | 881 | ||||||
| Lease liabilities | 195 | 224 | ||||||
| Other current liabilities | 3,194 | 2,915 | ||||||
| Total current liabilities | 4,326 | 4,020 | ||||||
| NON-CURRENT LIABILITIES | ||||||||
| Long-term lease liabilities | 542 | 685 | ||||||
| Other long-term liabilities | 69 | 618 | ||||||
| Total non-current liabilities | 611 | 1,303 | ||||||
| TOTAL LIABILITIES | 4,937 | 5,323 | ||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and outstanding: 36,814,554 and 35,780,335 shares as of June 30, 2022 and December 31, 2021, respectively | - | - | ||||||
| Additional paid-in capital | 86,275 | 85,389 | ||||||
| Accumulated deficit | ( 67,399 | ) | ( 58,431 | ) | ||||
| Total shareholders' equity | 18,876 | 26,958 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 23,813 | 32,281 |
The accompanying notes are an integral part
of the consolidated financial statements.
ICECURE MEDICAL LTD.
UNAUDITED INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
(U.S. dollars in thousands, except share
data and per share data)
| Six months ended June 30, | Six months ended June 30, | |||||||||||
| Note | 2022 | 2021 | ||||||||||
| Revenues | 4 | 1,512 | 2,073 | |||||||||
| Cost of revenues | 694 | 880 | ||||||||||
| Gross profit | 818 | 1,193 | ||||||||||
| Research and development expenses | 4,649 | 2,730 | ||||||||||
| Sales and marketing expenses | 1,533 | 625 | ||||||||||
| General and administrative expenses | 3,342 | 1,584 | ||||||||||
| Operating loss | 8,706 | 3,746 | ||||||||||
| Financial expenses (income), net | 262 | 101 | ||||||||||
| Net loss and comprehensive loss | 8,968 | 3,847 | ||||||||||
| Basic and diluted net loss per share | 0.244 | 0.156 | ||||||||||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 36,814,382 | 24,696,706 |
The accompanying notes
are an integral part of the consolidated financial statements.
ICECURE MEDICAL LTD.
UNAUDITED INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(U.S. dollars in thousands, except share
data and per share data)
| Ordinary shares | Treasury shares | Pre- funded warrants | Additional paid- in | Accumulated | Total shareholders' | |||||||||||||||||||||||||||||||
| Number | Amount | Number | Amount | Number | Amount | capital | deficit | equity | ||||||||||||||||||||||||||||
| Balance as of January 1, 2022 | 35,780,335 | - | - | - | 1,034,000 | - | 85,389 | ( 58,431 | ) | 26,958 | ||||||||||||||||||||||||||
| Share-based compensation related to options granted | - | - | - | - | - | - | 885 | - | 885 | |||||||||||||||||||||||||||
| Options exercised | 219 | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||
| Pre- funded warrants exercised | 1,034,000 | - | - | - | ( 1,034,000 | ) | - | 1 | - | 1 | ||||||||||||||||||||||||||
| Loss for the period | - | - | - | - | - | - | - | ( 8,968 | ) | ( 8,968 | ) | |||||||||||||||||||||||||
| Balance as of June 30, 2022 | 36,814,554 | - | - | - | - | - | 86,275 | ( 67,399 | ) | 18,876 | ||||||||||||||||||||||||||
| Balance as of January 1, 2021 | 20,218,220 | - | ( 5,434 | ) | ( 41 | ) | - | - | 54,225 | ( 48,536 | ) | 5,648 | ||||||||||||||||||||||||
| Issuance of ordinary shares, net(* ) | 11,485,697 | - | - | - | - | - | 14,586 | - | 15,586 | |||||||||||||||||||||||||||
| Options exercised ordinary shares | 69,018 | - | - | - | - | - | 56 | - | 56 | |||||||||||||||||||||||||||
| Share-based compensation related to options granted to employees | - | - | - | - | - | - | 184 | - | 184 | |||||||||||||||||||||||||||
| Cancelation of treasury shares | - | - | 5,434 | 41 | - | - | - | - | - | |||||||||||||||||||||||||||
| Loss for the period | - | - | - | - | - | - | - | ( 3,847 | ) | ( 3,847 | ) | |||||||||||||||||||||||||
| Balance as of June 30, 2021 | 31,772,935 | - | - | - | - | - | 69,010 | ( 52,383 | ) | 16,627 |
The accompanying notes are an integral part
of the consolidated financial statements.
ICECURE MEDICAL LTD.
UNAUDITED INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands, except share
data and per share data)
| Six months ended June 30, | Six months ended June 30, | |||||||
| 2022 | 2021 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | ( 8,968 | ) | ( 3,847 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 104 | 50 | ||||||
| Share-based compensation | 885 | 184 | ||||||
| Exchange rate changes in cash and cash equivalents and short time deposits | 562 | 97 | ||||||
| Changes in assets and liabilities: | ||||||||
| Decrease in trade accounts receivable | 272 | - | ||||||
| Increase in inventory | ( 696 | ) | ( 401 | ) | ||||
| Decrease (increase) in prepaid expenses and other receivables | 1,287 | ( 103 | ) | |||||
| Decrease in right of use assets | 95 | 19 | ||||||
| Increase in trade accounts payable | 56 | 159 | ||||||
| Decrease in lease liabilities | ( 172 | ) | ( 59 | ) | ||||
| Increase in other current liabilities | 279 | 368 | ||||||
| Decrease in other long-term liabilities | ( 549 | ) | ( 28 | ) | ||||
| Net cash used in operating activities | ( 6,845 | ) | ( 3,561 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Realization (investment in) of deposits | ( 4,277 | ) | 4,621 | |||||
| Investment in long term deposits | - | ( 295 | ) | |||||
| Purchase of property and equipment | ( 493 | ) | ( 247 | ) | ||||
| Net cash provided by (used in) investing activities | ( 4,770 | ) | 4,079 | |||||
| Cash flows from financing activities: | ||||||||
| Issuance of ordinary shares, net of issuance cost | - | 14,586 | ||||||
| Exercise of pre-funded warrants | 1 | - | ||||||
| Exercise of options to ordinary shares | - | 56 | ||||||
| Net cash provided by financing activities | 1 | 14,642 | ||||||
| Increase (decrease) in cash and cash equivalents | ( 11,614 | ) | 15,160 | |||||
| Cash and cash equivalents beginning of the year | 25,621 | 3,502 | ||||||
| Effect of foreign exchange rate on cash and cash equivalents | ( 539 | ) | ( 49 | ) | ||||
| Cash and cash equivalents end of the year | 13,468 | 18,613 |
ICECURE MEDICAL LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share
data and per share data)
IceCure Medical Ltd. ("IceCure
Medical Ltd.", the "Company", "we" or "our") is a medical device company incorporated in Israel.
The Company's ordinary shares
are listed on NASDAQ and the Tel Aviv Stock Exchange.
Since its establishment, IceCure Medical
Ltd., and its wholly-owned subsidiaries, IceCure Medical Inc. in the United States (the "US Subsidiary"), IceCure Medical HK
Limited, in Hong Kong (the "Hong Kong Subsidiary") and IceCure (Shanghai) MedTech Co., Ltd. in China (the "Chinese Subsidiary,
and together with the Company, the US Subsidiary and the Hong Kong Subsidiary, the "Group"), have been engaged in the research,
development and commercialization of minimally invasive medical devices for cryoablation (freezing) of tumors in the human body, using
its propriety liquid nitrogen cryoablation technology, as an alternative to surgical intervention to remove the tumor. The Company received
regulatory approvals for marketing its products in the United States, Europe and other territories.
The US Subsidiary was established on
April 6, 2011 in the State of Delaware and is engaged in business development, marketing, clinical trial management and sale of the Company's
products in the United States. The Hong Kong Subsidiary was established on September 26, 2018 and commenced its activity in 2021. The
Chinese Subsidiary was established on July 14, 2020, and is wholly owned by the Hong Kong Subsidiary. The Chinese Subsidiary in China
commenced its operation on January 1, 2021 and is engaged in business development and obtaining regulatory approvals for the Company's
The Group's activities are subject
to significant risks and uncertainties, including failing to secure additional funding to commercialize its technology, obtaining regulatory
approvals and other risks. In addition, the Group is subject to risks from, among other things, competition associated with the industry
in general, other risks associated with financing, liquidity requirements, rapidly changing customer requirements and limited operating
As of June 30, 2022, the Company has
accumulated losses of $67,399. In the six months ended June 30, 2022, the Company generated losses of $8,968 and negative cash flows from
operating activities of $6,845.
To date, management expects the Company
to continue to generate substantial operating losses and to continue to fund its operations primarily through utilization of its current
financial resources, sales of its products, and through additional raising of capital. As of August 31, 2022, the Company's cash,
cash equivalents and short-term deposits were $15,388.
Management expects that its cash, cash
equivalents and short-term deposits, as of the issuance date of the financial statements, will be sufficient for 12 months of operations.
ICECURE MEDICAL LTD.
NOTES TO THE UNAUDITED INTERIM CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share
data and per share data)
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING
The unaudited interim condensed consolidated
financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States
("U.S. GAAP"). Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial
statements. The information included in these condensed interim financial statements should be read in conjunction with the consolidated
financial statements and accompanying notes included in the Company's annual financial statements. In the opinion of management,
these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary
for a fair statement of results for the interim period. The results for the interim periods are not necessarily indicative of the results
to be expected for the full year.
The preparation of consolidated financial
statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the consolidated financial statements and
the reported amounts of revenues and expenses during the reporting period. Management believes that the estimates, judgments and assumptions
used are reasonable based upon information available at the time they are made. Actual results could differ from those estimates.
The significant accounting policies
followed in the preparation of these unaudited interim condensed consolidated financial statements are identical to those applied in the
preparation of the latest annual financial statements.
In August 2020, the FASB (Financial Accounting
Standards Board) issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, which
simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments
and contracts in an entity's own equity. Among other changes, ASU No. 2020-06 removes from U.S. GAAP the liability and equity separation
model for convertible instruments with a cash conversion feature, and as a result, after adoption, entities will no longer separately
present in equity an embedded conversion feature for such debt. ASU No. 2020-06 also eliminates the treasury stock method to calculate
diluted earnings per share and requires the if-converted method. This new standard will be effective for us in fiscal years beginning
after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years
beginning after December 15, 2020. We are currently assessing the impact of adopting this standard on our financial statements.
In December 2019, the FASB issued
ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which affects general principles within Topic
740, Income Taxes and is meant to simplify and reduce the cost of accounting for income taxes. This standard is effective for annual reporting
periods beginning after December 15, 2021, and interim reporting periods within annual reporting periods beginning after December 15,
2022. We are currently reviewing this standard but do not expect that it will have a material impact on our financial statements.
ICECURE MEDICAL LTD.