Full Press Release Details
Medical Reports First Quarter 2022 Financial Results and
Operational Highlights
Israel, May 18, 2022 -- 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 quarter ended March 31, 2022 and
operational highlights.
2022 Operational and Financial Highlights
the reopening of global travel and healthcare systems' return to relative normalcy throughout most of the world, during the first
quarter of 2022 we significantly increased our activity, getting ProSense in front of more doctors who can purchase and use it to
improve patient outcomes," stated IceCure CEO Eyal Shamir. "We were particularly pleased that our ICE3 clinical trial publication
was chosen as one of the Best Papers of 2021 by the American Association of Breast Cancer Surgeons, a highly regarded and influential
organization that sets the treatment guidelines for breast cancer in the U.S."
Results as of and for the Three Months Ended March 31, 2022
the three months ended March 31, 2022, revenue decreased by 48% to approximately $0.75 million, compared to approximately $1.4 million
for the three months ended March 31, 2021. The decrease is due to decreased revenue recognition of approximately $0.4 million from the
distribution agreement with Terumo and a decrease in sales in Asia, partially offset by an increase in sales in the U.S.
profit was approximately $0.43 million for the three months ended March 31, 2022, compared to approximately $0.94 million for the three
months ended March 31, 2021. Gross margin was approximately 58% for the three month period ended March 31, 2022, compared to approximately
65% for the three months ended March 31, 2021. The decrease in gross margin compared to the same period last year is mostly attributable
to the decrease in revenue recognition from the Terumo distribution agreement.
and development expenses for the three months ended March 31, 2022 were approximately $2.4 million compared to approximately $1.1 million
for the three months ended March 31, 2021. The increase is attributed to the acceleration in the development of IceCure's next-generation
single-probe system and clinical and regulatory activities.
and marketing and general and administrative expenses, in the aggregate, for the three months ended March 31, 2022 were $2.5 million
compared to approximately $1 million for the three months ended March 31, 2021. The increase is attributed to the Company's expanding
commercialization efforts and to increased Nasdaq listing related expenses.
operating expenses for the three months ended March 31, 2022 were approximately $4.9 million compared to $2.1 million for the three months
March 31, 2021. The increase in operating expenses is attributable to increased development, commercialization, and Nasdaq listing related
a result of lower revenue and increased operation activities, net loss reported for the three month period ended March 31, 2022 increased
to approximately $4.4 million, or $0.12 per share, compared with a net loss of approximately $1.4 million, or $0.07 per share, for the
same period last year.
of March 31, 2022, the Company had cash and cash equivalents of approximately $22.4 million, compared with approximately $25.6 million
as of December 31, 2021.
May 18, 2022 at 8:30 am ET
Israel/International:
replay of the conference call will be available on IceCure's website at: https://ir.icecure-medical.com/news-events/events-presentations
in 2006, Israel-based 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 with the CE Mark.
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 and FDA review, strategic plans, commercial growth,
expansion of clinical applications with its minimally-invasive cryoablation technology, advancing regulatory and commercial strategies
and expected quarter-over-quarter revenue variations 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.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| As of March 31, 2022 | As of December 31, 2021 | |||||||
| (Unaudited) | (Audited) | |||||||
| U.S. dollars in thousands | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | 22,355 | 25,621 | ||||||
| Trade accounts receivables | 446 | 456 | ||||||
| Inventory | 2,324 | 1,955 | ||||||
| Prepaid expenses and other receivables | 1,562 | 2,290 | ||||||
| Total current assets | 26,687 | 30,322 | ||||||
| NON-CURRENT ASSETS | ||||||||
| Prepaid expenses and other long-term assets | 333 | 333 | ||||||
| Right-of-use assets | 884 | 913 | ||||||
| Property and equipment, net | 805 | 713 | ||||||
| Total non-current assets | 2,022 | 1,959 | ||||||
| TOTAL ASSETS | 28,709 | 32,281 | ||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Trade accounts payable | 670 | 881 | ||||||
| Lease liabilities | 230 | 224 | ||||||
| Other current liabilities | 4,046 | 2,915 | ||||||
| Total current liabilities | 4,946 | 4,020 | ||||||
| NON-CURRENT LIABILITIES | ||||||||
| Long-term lease liabilities | 617 | 685 | ||||||
| Other long-term liabilities | 185 | 618 | ||||||
| Total non-current liabilities | 802 | 1,303 | ||||||
| Total liabilities | 5,748 | 5,323 | ||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and outstanding: 35,780,335 shares as of March 31, 2022 and December 31, 2021, respectively | ||||||||
| Pre-funded warrants to ordinary shares, Issued and outstanding: 1,034,000 Pre-funded warrants and zero Pre-funded warrants as of March 31, 2022 and December 31, 2021, respectively | - | - | ||||||
| Additional paid-in capital | 85,839 | 85,389 | ||||||
| Accumulated deficit | (62,878 | ) | (58,431 | ) | ||||
| Total shareholders' equity | 22,961 | 26,958 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 28,709 | 32,281 |
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
| Three months ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| U.S. dollars in thousands (except per share data) | ||||||||
| Revenues | 747 | 1,436 | ||||||
| Cost of revenues | 313 | 497 | ||||||
| Gross profit | 434 | 939 | ||||||
| Research and development expenses | 2,394 | 1,144 | ||||||
| Sales and marketing expenses | 747 | 298 | ||||||
| General and administrative expenses | 1,718 | 690 | ||||||
| Operating loss | 4,425 | 1,193 | ||||||
| Financial expenses, net | 22 | 178 | ||||||
| Net loss and comprehensive loss | 4,447 | 1,371 | ||||||
| Basic and diluted net loss per share | 0.12 | 0.07 | ||||||
| Weighted average number of shares outstanding used in computing basic and diluted loss per share | 36,814,335 | 20,739,571 |
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
| Three months ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| U.S. dollars in thousands | ||||||||
| Cash flows from operating activities | ||||||||
| Net loss | (4,447 | ) | (1,371 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 52 | 23 | ||||||
| Share-based compensation | 450 | 97 | ||||||
| Exchange rate changes in cash and cash equivalents and short time deposits | 62 | 206 | ||||||
| Changes in assets and liabilities: | ||||||||
| Decrease (increase) in trade accounts receivables | 10 | (156 | ) | |||||
| Decrease (increase) in prepaid expenses and other receivables | 728 | (109 | ) | |||||
| Increase in inventory | (369 | ) | (137 | ) | ||||
| Decrease in right of use assets | 29 | 43 | ||||||
| Increase (decrease) in trade accounts payable | (211 | ) | 20 | |||||
| Decrease in lease liabilities | (62 | ) | (33 | ) | ||||
| Increase (decrease) in other current liabilities | 1,131 | (252 | ) | |||||
| Decrease in other long-term liabilities | (433 | ) | (174 | ) | ||||
| Net cash used in operating activities | (3,060 | ) | (1,843 | ) | ||||
| Cash flows from investing activities | ||||||||
| Investment of deposits | - | 4,621 | ||||||
| Purchase of property and equipment | (144 | ) | (69 | ) | ||||
| Net cash provided by (used in) investing activities | (144 | ) | 4,552 | |||||
| Cash flows from financing activities | ||||||||
| Issuance of ordinary shares, net of issuance cost | - | 8,880 | ||||||
| Exercise of options to ordinary shares | - | 52 | ||||||
| Net cash provided by financing activities | - | 8,932 | ||||||
| Increase (decrease) in cash and cash equivalents | (3,204 | ) | 11,641 | |||||
| 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 | (62 | ) | (158 | ) | ||||
| Cash and cash equivalents at end of period | 22,355 | 14,985 |