Full Press Release Details
IceCure Medical Reports Financial Results for
the First Half of 2022 and Recent Operational Highlights
Israel, Aug. 15, 2022 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"),
developer of minimally-invasive cryoablation technology, the ProSense System, that destroys tumors by freezing as
an alternative to surgical tumor removal ("ProSense"), today reported financial results as of and for the six months June
30, 2022 and operational and commercial highlights for the second quarter.
2022 Commercial & Operational Highlights
"The second quarter of 2022 marked continued
momentum in the commercial rollout of our cryoablation systems highlighted by our exclusive distribution agreement in China with Shanghai
Medtronic Zhikang Medical Devices Co. Ltd., an affiliate of Medtronic, the world's largest medical device company. We believe
this is a very strong endorsement of our technology, and the increased market interest we're seeing globally confirm our view,"
stated IceCure CEO Eyal Shamir. "Based on the level of commercial interest during and after the second quarter, we expect the number
of these system installations and sales may potentially increase. We believe that this activity will be reflected in our revenues in the
Financial Results for the Six Months Ended
For the six months ended June 30, 2022, revenue
decreased by 27% to approximately $1.5 million, compared to approximately $2.1 million for the six months ended June 30, 2021. The decrease
is due to decreased revenue recognition of approximately $0.4 million from the distribution agreements with Terumo Corporation and a decrease
in sales in Asia, partially offset by an increase in sales in the U.S. and Europe.
Gross profit was approximately $0.8 million for
the six months ended June 30, 2022, compared to approximately $1.2 million for the six months ended June 30, 2021. The gross margin was
approximately 54% for the six months ended June 30, 2022, compared to approximately 58% for the six months ended June 30, 2021. The decrease
in gross margin compared to the same period last year is attributable to the decrease in sales and in revenue recognition from the Terumo
distribution agreement.
Research and development expenses for the six
months ended June 30, 2022 were approximately $4.6 million compared to approximately $2.7 million for the six months ended June 30, 2021.
The increase is attributed to acceleration in the development of IceCure's next-generation single-probe system and due to clinical
and regulatory activities.
Sales and marketing and general and administrative
expenses, in the aggregate, for the six months ended June 30, 2022 were $4.9 million compared to approximately $2.2 million for the six
months ended June 30, 2021. The increase is attributed to the Company's expanding commercialization efforts and to increased Nasdaq
listing-related expenses.
Total operating expenses for the six months ended
June 30, 2022 were approximately $9.5 million compared to $4.9 million for the six months ended June 30, 2021. The increase in operating
expenses is attributable to increased development, commercialization, and Nasdaq listing-related activities.
As a result of lower revenue and increased operation
activities, net loss reported for the six months ended June 30, 2022 increased to approximately $9.0 million, or $0.24 per share, compared
with a net loss of approximately $3.8 million, or $0.16 per share, for the same period last year.
As of June 30, 2022, the Company had cash and
cash equivalents including short-term deposits of approximately $17.7 million, compared with approximately $25.6 million as of December
Conference Call Dial-in Info:
Monday, August 15, 2022 at 4:30 pm EDT
Israel/International: +972-3-9180609
A replay of the conference call will be available
on IceCure's website at: https://ir.icecure-medical.com/news-events/events-presentations
About IceCure Medical
IceCure Medical (NASDAQ: ICCM) (TASE: 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 to-date by the U.S. Food and Drug Administration and approved in Europe
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
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 pursuit of regulatory approvals
in various jurisdictions, strategic plans, commercial growth, expansion of clinical applications and potential market adoption of its
minimally-invasive cryoablation technology, advancing regulatory and commercial strategies and expected quarter-over-quarter revenue variations
and other key business highlights for future periods. 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, 2021 filed
with the SEC on April 1, 2022, which is 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.
ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS
OF FINANCIAL POSITION
| As of June 30, 2022 | As of December 31, 2021 | |||||||
| (Unaudited) | (Audited) | |||||||
| U.S. dollars in thousands | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | 13,468 | 25,621 | ||||||
| Short-term deposits | 4,257 | - | ||||||
| Trade accounts receivables | 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 |
ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS (Unaudited)
| Six months ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| U.S. dollars in thousands (except per share data) | ||||||||
| Revenues | 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, 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 loss per share | 36,814,382 | 24,696,706 |
ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS (Unaudited)
| Six months ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| U.S. dollars in thousands | ||||||||
| 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 receivables | 272 | - | ||||||
| Decrease (increase) in prepaid expenses and other receivables | 1,287 | (103 | ) | |||||
| Increase in inventory | (696 | ) | (401 | ) | ||||
| 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 | |||||
| Investments of 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 at beginning of the year | 25,621 | 3,502 | ||||||
| Effect of exchange rate fluctuations on balances of cash and cash equivalents | (539 | ) | (49 | ) | ||||
| Cash and cash equivalents at end of period | 13,468 | 18,613 |