Exhibit 99.1
ICECURE MEDICAL LTD.
UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET
(U.S. dollars in thousands, except share data and per share data)
As of June 30, | As of December 31, | |||||||
2024 | 2023 | |||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | ||||||||
Short-term deposits | ||||||||
Trade receivables | ||||||||
Inventory | ||||||||
Prepaid expenses and other receivables | ||||||||
Total current assets | ||||||||
NON-CURRENT ASSETS | ||||||||
Prepaid expenses and other long-term assets | ||||||||
Right of use assets | ||||||||
Property and equipment, net | ||||||||
Total non-current assets | ||||||||
TOTAL ASSETS | ||||||||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
CURRENT LIABILITIES | ||||||||
Trade payables | ||||||||
Lease liabilities | ||||||||
Employees and other current liabilities | ||||||||
Total current liabilities | ||||||||
NON-CURRENT LIABILITIES | ||||||||
Long-term lease liabilities | ||||||||
Total non-current liabilities | ||||||||
TOTAL LIABILITIES | ||||||||
SHAREHOLDERS' EQUITY | ||||||||
Ordinary shares, | par value per share; Authorized ||||||||
Additional paid-in capital | ||||||||
Accumulated deficit | ( | ) | ( | ) | ||||
Total shareholders’ equity | ||||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
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 | 2024 | 2023 | ||||||||
Revenues | 4 | |||||||||
Cost of revenues | ||||||||||
Gross profit | ||||||||||
Research and development expenses | ||||||||||
Sales and marketing expenses | ||||||||||
General and administrative expenses | ||||||||||
Operating loss | ||||||||||
Finance income, net | ( | ) | ( | ) | ||||||
Net loss and comprehensive loss | ||||||||||
The accompanying notes are an integral part of the consolidated financial statements.
2
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 | Additional paid- in | Accumulated | Total shareholders' | |||||||||||||||||
Number | Amount | capital | deficit | equity | ||||||||||||||||
Balance as of January 1, 2024 | ( | ) | ||||||||||||||||||
Issuance of ordinary shares, net of issuance cost of $ | ||||||||||||||||||||
Share-based compensation | ||||||||||||||||||||
Loss for the period | - | ( | ) | ( | ) | |||||||||||||||
Balance as of June 30, 2024 | ( | ) | ||||||||||||||||||
Balance as of January 1, 2023 | ( | ) | ||||||||||||||||||
Share-based compensation | - | |||||||||||||||||||
Issuance of restricted shares | ||||||||||||||||||||
Loss for the period | - | ( | ) | ( | ) | |||||||||||||||
Balance as of June 30, 2023 | ( | ) |
The accompanying notes are an integral part of the consolidated financial statements.
3
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, | |||||||
2024 | 2023 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | ( | ) | ( | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation | ||||||||
Share-based compensation | ||||||||
Exchange rate changes in cash and cash equivalents and short-term deposits | ||||||||
Non-cash short-term deposits interest | ( | ) | ( | ) | ||||
Changes in assets and liabilities: | ||||||||
Increase in trade receivables | ( | ) | ( | ) | ||||
Decrease in prepaid expenses and other receivables | ||||||||
Decrease in inventory | ||||||||
Decrease in right of use assets | ||||||||
Increase (decrease) in trade payables | ( | ) | ||||||
Decrease in lease liabilities | ( | ) | ( | ) | ||||
Increase (decrease) in employees and other current liabilities | ( | ) | ||||||
Net cash used in operating activities | ( | ) | ( | ) | ||||
Cash flows from investing activities: | ||||||||
Investment in of short-term deposits | ( | ) | ( | ) | ||||
Withdrawal of short-term deposits | ||||||||
Investment in restricted long-term deposits | ( | ) | ||||||
Purchase of property and equipment | ( | ) | ( | ) | ||||
Net cash used in investing activities | ( | ) | ( | ) | ||||
Cash flows from financing activities: | ||||||||
Issuance of ordinary shares, net of issuance costs | ||||||||
Net cash provided by financing activities | ||||||||
Decrease in cash and cash equivalents | ( | ) | ( | ) | ||||
Cash and cash equivalents beginning of the year | ||||||||
Effect of foreign exchange rate on cash and cash equivalents | ( | ) | ( | ) | ||||
Cash and cash equivalents end of the year | ||||||||
Non-cash activities | ||||||||
Obtaining a right-of-use asset in exchange for a lease liability |
The accompanying notes are an integral part of the consolidated financial statements.
4
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 1 - GENERAL
A. | Description of the Company: |
IceCure Medical Ltd. ("IceCure Medical Ltd.", the “Company”, "we" or "our") is a medical device company incorporated in Israel.
The Company’s ordinary shares, no par value per share (the “Ordinary Shares”) are listed on the Nasdaq Capital Market.
Since its establishment, the Company 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 tumors. 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 the 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 operations on January 1, 2021 and is engaged in business development and obtaining regulatory approvals for the Company's products in China.
The Group’s activities are subject to significant risks and uncertainties, including the possibility of 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 history.
B. | Going Concern: |
As of June 30, 2024, the Company has
accumulated losses of $
To date, management expects the Company to continue to generate substantial operating losses and fund its operations primarily through utilization of its current financial resources, sales of its products, and additional raises of capital.
5
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 1 - GENERAL (Cont.)
B. | Going Concern (Cont.): |
Such conditions raise substantial doubts about the Company’s ability to continue as a going concern. Management’s plan to continue as a going concern includes raising funds from existing shareholders and/or new investors. However, there is no assurance such funding will be available to the Company or that it will be obtained on terms favorable to the Company or will provide the Company with sufficient funds to successfully complete the development of, and to commercialize, its products. These financial statements do not include any adjustments relating to the recoverability and classification of assets, carrying amounts or the amount and classification of liabilities that may be required should the Company be unable to continue as a going concern.
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A. | Basis of presentation |
The unaudited interim condensed consolidated financial statements of the Company as of June 30, 2024, and for the six months period then ended 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 audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission on April 3, 2024. 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 ending December 31, 2024.
B. | Use of estimates: |
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.
C. | Significant Accounting Policies |
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.
6
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 POLICIES (Cont.)
D. | New Accounting Pronouncements Not Yet Effective: |
Recent accounting pronouncements not yet adopted:
In November 2023, the Financial Accounting Standards Board (“FASB”) issued an Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly reviewed by the chief operating decision maker ("CODM") and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. The ASU also allows, in addition to the measure that is most consistent with U.S. GAAP, the disclosure of additional measures of segment profit or loss that are used by the CODM in assessing segment performance and deciding how to allocate resources. The ASU is effective for the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2024, and subsequent interim periods, with early adoption permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires disclosure of specific categories in the rate reconciliation and additional information for reconciling items that meet a quantitative threshold. The amendment also includes other changes to improve the effectiveness of income tax disclosures, including further disaggregation of income taxes paid for individually significant jurisdictions. This ASU is effective for annual periods beginning after December 15, 2024. Adoption of this ASU should be applied on a prospective basis. Early adoption is permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
NOTE 3 - SHAREHOLDERS’ EQUITY
On January 12, 2024, we entered into
an equity distribution agreement with Maxim Group LLC, as sales agent (the “Sales Agent”), pursuant to which we may offer
and sell Ordinary Shares having an aggregate offering price of up to $
7
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 4 - REVENUES
Composition:
Six months ended June 30, | Six months ended June 30, | |||||||
2024 | 2023 | |||||||
Consoles | ||||||||
Disposables | ||||||||
Exclusive distribution agreement and other services | ||||||||
NOTE 5 - GEOGRAPHIC AND SIGNIFICANT CUSTOMER INFORMATION
The Company has identified
Six months ended June 30, | Six months ended June 30, | |||||||
2024 | 2023 | |||||||
United States | ||||||||
Japan | ||||||||
India | ||||||||
China | ||||||||
Israel | ||||||||
Other1 | ||||||||
1 |
8
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 6 - SUBSEQUENT EVENTS
The following are the significant events that took place subsequent to June 30, 2024:
A. | As of August 15, 2024, we have sold additional |
B. | On July 2, 2024, the Company granted |
9