Full Press Release Details
IceCure Medical Reports First Quarter 2023 Financial
& Operational Results
CAESAREA, Israel, May 22, 2023 -- IceCure
Medical Ltd. (the "Company" or "IceCure") (Nasdaq: ICCM) (TASE: ICCM) 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 three months ended March 31, 2023 as well as operational and recent corporate developments.
"ProSense is gaining heightened interest
among breast surgeons, breast radiologists, and interventional oncologists globally and particularly in the U.S. where we are focusing
our commercialization and marketing efforts. We believe this momentum in the market is bolstered by a broader trend toward minimally invasive
procedures," stated IceCure CEO Eyal Shamir.
"We continue to engage with the U.S. Food
and Drug Administration ("FDA") following the October 2022 filing for marketing authorization for
ProSense for early-stage low risk breast cancer in patients who are at high risk for surgery. These ongoing discussions are part
of the regulatory submission process. Concurrently, we are highly encouraged by the American Society of Breast Surgeons' ("ASBrS")
expressed plans for a cryoablation trial. We believe that such a planned trial could potentially establish a new minimally invasive standard
for the treatment of low risk, early-stage breast cancer. We further believe it will support our commercialization plans, and raise awareness
among ASBrS members, which include 3,000 of the most influential physicians in breast surgery."
"Globally, we continue to build momentum
through regulatory submissions and approvals including in China where our IceSense3 system and cryoprobes are now fully approved for commercial
use. In addition, we were pleased to learn of the favorable results from an independent study in France where ProSense and another cryoablation
technology were used to treat endometriosis. We expect the continued adoption of ProSense through the rest of 2023."
"Our cash position at the end of the quarter
remains strong at over $20 million, and we believe our continued prudent management of our financial resources gives us the confidence
to invest in our U.S. commercialization activities as we await the FDA's response."
First Quarter of 2023 and Recent Operating
Financial Results as of and for the Three Months
Ended March 31, 2023
For the three months ended March 31, 2023, the
Company reported revenue of $0.71 million compared to revenue of $0.75 million for the three months ended March 31, 2022. In the first
quarter of 2023, sales increased in the U.S. and Europe relative to the same quarter last year.
Gross profit was $0.32 million for the three months
ended March 31, 2023, compared to approximately $0.43 million for the three months ended March 31, 2022. Gross margin was 45% for the
three months ended March 31, 2023, compared to 58% for the three months ended March 31, 2022. The decrease in gross margin compared to
the same period last year resulted mostly from an increase in manufacturing costs.
Research and development expenses for the three
months ended March 31, 2023, were $2.11 million compared to $2.39 million for the three months ended March 31, 2022. The decrease was
primarily due to a reduction in development expenses of IceCure's next-generation single-probe system, partially offset by an increase
in clinical and regulatory activities.
As a result of the Company's expanding commercialization
efforts, sales and marketing expenses for the three months ended March 31, 2023, were $1.08 million, compared to $0.75 million for the
three months ended March 31, 2022.
General and administrative expenses for the three
months ended March 31, 2023, were $1.09 million, compared to $1.72 million for the three months ended March 31, 2022. The decrease is
mainly due to a decrease in the cost of directors' and officers' insurance.
Total operating expenses for the three months
ended March 31, 2023, were $4.28 million, compared to $4.86 million for the three months ended March 31, 2022. The decrease in operating
expenses was primarily attributable to a reduction in research and development expenses and cost of directors' and officers' insurance.
Net loss reported for the three months ended March 31, 2023, decreased to $3.77 million, or $0.08 per share, compared with a net loss
of $4.45 million, or $0.12 per share, for the same period last year.
As of March 31, 2023, the Company had cash and
cash equivalents, including short-term deposits, of approximately $20.46 million, compared to $23.66 million as of December 31, 2022.
Conference call & webcast info:
May 22, 2023, at 10:00 am ET
Israel/International: +972-3-9180609
A live webcast will be available at: https://veidan.activetrail.biz/IcecureQ1-2023
A recording of the webcast will be available at:
IceCure Medical Ltd. (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 and approved to date including in the U.S., Europe, and China.
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 statements in this press release when it discusses the heightened
interest and momentum in the market for its products, its commercialization and marketing efforts, its regulatory strategy, the
ASBrS's plans for a cryoablation trial, its belief that such a trial could establish a
new minimally invasive standard for the treatment of low risk, early-stage breast cancer and that it will support its
commercialization process and make physicians aware of and participate in the trial being planned, the
expected continued adoption of ProSense through the rest of 2023, its anticipation of the FDA's response to regulatory
requests for approvals, the potential of IceCure's product portfolio expansion into thinner cryoprobes and catheters through
its granted patents in the U.S. and Japan, expansion of clinical applications and potential market adoption of its
minimally-invasive cryoablation technology and the dates related to the voluntary delisting of the Company's ordinary shares
from the TASE. 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.
Email: mpolyviou@evcgroup.com
Email: tkehrli@evcgroup.com
ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL
| As of March 31, 2023 | As of December 31, 2022 | |||||||
| (Unaudited) | (Audited) | |||||||
| U.S. dollars in thousands | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | 5,594 | 23,659 | ||||||
| Deposits | 14,870 | - | ||||||
| Restricted deposit | 296 | 296 | ||||||
| Trade accounts receivables | 143 | 78 | ||||||
| Inventory | 2,928 | 2,857 | ||||||
| Prepaid expenses and other receivables | 866 | 1,240 | ||||||
| Total current assets | 24,697 | 28,130 | ||||||
| NON-CURRENT ASSETS | ||||||||
| Prepaid expenses and other long-term assets | 34 | 34 | ||||||
| Right-of-use assets | 620 | 668 | ||||||
| Property and equipment, net | 1,527 | 1,356 | ||||||
| Total non-current assets | 2,181 | 2,058 | ||||||
| TOTAL ASSETS | 26,878 | 30,188 | ||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Trade accounts payable | 685 | 714 | ||||||
| Lease liabilities | 164 | 167 | ||||||
| Other current liabilities | 3,643 | 3,455 | ||||||
| Total current liabilities | 4,492 | 4,336 | ||||||
| NON-CURRENT LIABILITIES | ||||||||
| Long-term lease liabilities | 376 | 430 | ||||||
| Total non-current liabilities | 376 | 430 | ||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and outstanding: 45,623,434 shares as of March 31, 2023 and December 31, 2022, respectively | ||||||||
| Additional paid-in capital | 101,187 | 100,831 | ||||||
| Accumulated deficit | (79,177 | ) | (75,409 | ) | ||||
| Total shareholders' equity | 22,010 | 25,422 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 26,878 | 30,188 |
ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| U.S. dollars in thousands (except per share data) | ||||||||
| Revenues | 710 | 747 | ||||||
| Cost of revenues | 390 | 313 | ||||||
| Gross profit | 320 | 434 | ||||||
| Research and development expenses | 2,111 | 2,394 | ||||||
| Sales and marketing expenses | 1,075 | 747 | ||||||
| General and administrative expenses | 1,091 | 1,718 | ||||||
| Operating loss | 3,957 | 4,425 | ||||||
| Financial expenses (income), net | (189 | ) | 22 | |||||
| Net loss and comprehensive loss | 3,768 | 4,447 | ||||||
| Basic and diluted net loss per share | 0.08 | 0.12 | ||||||
| Weighted average number of shares outstanding used in computing basic and diluted loss per share | 45,623,434 | 36,814,335 |
ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| Three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| U.S. dollars in thousands | ||||||||
| Cash flows from operating activities | ||||||||
| Net loss | (3,768 | ) | (4,447 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 79 | 52 | ||||||
| Share-based compensation | 356 | 450 | ||||||
| Exchange rate changes in cash and cash equivalents and short time deposits | 8 | 62 | ||||||
| Changes in assets and liabilities: | ||||||||
| Decrease (increase) in trade accounts receivables | (65 | ) | 10 | |||||
| Decrease in prepaid expenses and other receivables | 374 | 728 | ||||||
| Increase in inventory | (71 | ) | (369 | ) | ||||
| Decrease in right of use assets | 48 | 29 | ||||||
| Decrease in trade accounts payable | (29 | ) | (211 | ) | ||||
| Decrease in lease liabilities | (57 | ) | (62 | ) | ||||
| Increase in other current liabilities | 188 | 1,131 | ||||||
| Decrease in other long-term liabilities | - | (433 | ) | |||||
| Net cash used in operating activities | (2,937 | ) | (3,060 | ) | ||||
| Cash flows from investing activities | ||||||||
| Investment in short-term deposits | (14,870 | ) | - | |||||
| Purchase of property and equipment | (250 | ) | (144 | ) | ||||
| Net cash provided by (used in) investing activities | (15,120 | ) | (144 | ) | ||||
| Increase (decrease) in cash and cash equivalents | (18,057 | ) | (3,204 | ) | ||||
| 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 | (8 | ) | (62 | ) | ||||
| Cash and cash equivalents at end of period | 5,594 | 22,355 |