Full Press Release Details
Medical Reports Financial Results for the First Half of 2021 and Recent Operating Highlights
Israel, September 23, 2021 -- IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"),
developer of the next generation minimally invasive cryoablation technology that destroys tumors by freezing, today reported its financial
results as of and for the six-month period ended June 30, 2021.
Half 2021 and Recent Operating Highlights
am excited by our team's growing list of accomplishments throughout the business thus far in 2021. This includes the significant
progress we've made expanding the global distribution network for our ProSense Cryoablation System. This steady growth is especially
impressive taking into account the impact of the ongoing global pandemic. I have great appreciation for the team we've put together
and their continued efforts to bring our system to patients," commented Eyal Shamir, Chief Executive Officer of IceCure.
the most commonly diagnosed cancer, breast cancer continues to be a serious life-threatening disease with an estimated 325,0001
new breast cancer cases diagnosed in the U.S. in 2020, and more than 2.3 million new cases worldwide in 20202. The incidence
of breast cancer is expected to continue to rise, with the U.S. National Cancer Institute estimating a 50% increase in new cases of breast
cancer in 20303. As such, we have dedicated a tremendous amount of our time and resources towards treating breast cancer with
our ProSense System, which we believe enables shorter, simpler, and cost-effective procedures with lower risk of complications,"
continued Mr. Shamir. "We are working relentlessly to establish a regulatory path towards making the ProSense System available
to early-stage breast cancer patients in the U.S. or high-risk patients to surgery as a minimal invasive treatment."
a Nasdaq listed company has made it easier for global institutional investors to be part of our journey. It also helps us expand our
global reach and execute on our international expansion through a distribution network of leading medical device companies and distributors
across Europe, Asia, the Middle East, and Latin America. These partners provide specialized local experience and resources to navigate
each country's regulatory pathways and distribution needs. We believe there are tremendous opportunities to continue building out
this network with new and existing partners in additional countries and territories," concluded Mr. Shamir.
Results for the Six-Month Period Ended June 30, 2021
the six months ended June 30, 2021, revenue increased by 12% to approximately $2.1 million, compared to approximately $1.9 million for
the six months ended June 30, 2020.
profit was $1.2 million for the six months ended June 30, 2021, which is relatively unchanged compared to the six months ended June 30,
2020. Gross margin was 58% for the six-month period ended June 30, 2021, compared to 62% for the six months ended June 30, 2020. The
decrease in gross margin compared to the same period last year is attributable to the changes in the mix of products sold, and sales
to distributors instead of direct sales to end customers.
operating expenses for the six months ended June 30, 2021 were approximately $4.9 million. Total operating expenses for the six months
ended June 30, 2020 were approximately $2.8 million. The increase in operating expenses is attributable to the development of the Company's
next generation cryoablation systems and probes and the Nasdaq listing related expenses.
a result of the increase of the Company's expenses, net loss reported for the six-month period ended June 30, 2021, increased to
approximately $3.8 million, or $0.16 per share, compared with a net loss of approximately $1.6 million, or $0.11 per share, for the same
of June 30, 2021, the Company had cash and cash equivalents of approximately $18.6 million, compared with approximately $3.5 million
as of December 31, 2020.
in 2006, Israel-based IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) develops and markets 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, after receiving certain FDA and CE approvals.
| 1 The National Breast Cancer Foundation, Inc. | - https://www.nationalbreastcancer.org/wp-content/uploads/2020-Breast-Cancer-Stats.pdf |
| 2 The World Health Organization (WHO) | - https://www.who.int/news-room/fact-sheets/detail/breast-cancer |
| 3 National Cancer Institute | - https://www.cancer.gov/news-events/cancer-currents-blog/2015/breast-forecast |
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 the development of distribution networks for its products, the Company's regulatory strategy and developing a
regulatory path towards approvals of its ProSense System, commercialization activities and the market opportunity for the Company's
ProSense Cryoablation System in Turkey, India, Brazil and other countries across the Middle-East, Europe, Asia, and Latin America. 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 Registration Statement on Form F-1 filed with the SEC on August 10, 2021. Copies 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.
646-627-8390 / c: 917-741-7792
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| As of June 30, 2021 | As of December 31, 2020 | |||||||
| (Unaudited) | (Audited) | |||||||
| U.S. dollars in thousands | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | 18,613 | 3,502 | ||||||
| Deposit | - | 4,669 | ||||||
| Trade accounts receivables | 94 | 94 | ||||||
| Inventory | 1,465 | 1,064 | ||||||
| Prepaid expenses and other receivables | 363 | 260 | ||||||
| Total current assets | 20,535 | 9,589 | ||||||
| NON-CURRENT ASSETS | ||||||||
| Prepaid expenses and other long-term assets | 331 | 37 | ||||||
| Right-of-use assets | 287 | 306 | ||||||
| Property and equipment, net | 504 | 307 | ||||||
| Total non-current assets | 1,122 | 650 | ||||||
| TOTAL ASSETS | 21,657 | 10,239 | ||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Trade accounts payable | 804 | 645 | ||||||
| Lease liabilities | 180 | 214 | ||||||
| Other current liabilities | 3,223 | 2,855 | ||||||
| Total current liabilities | 4,207 | 3,714 | ||||||
| NON-CURRENT LIABILITIES | ||||||||
| Long-term lease liabilities | 92 | 118 | ||||||
| Other long-term liabilities | 731 | 759 | ||||||
| Total non-current liabilities | 823 | 877 | ||||||
| Total liabilities | 5,030 | 4,591 | ||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and outstanding: 31,772,935 shares and 20,218,220 shares as of June 30, 2021 and December 31, 2020, respectively | ||||||||
| Treasury shares | - | (41 | ) | |||||
| Additional paid-in capital | 69,010 | 54,225 | ||||||
| Accumulated deficit | (52,383 | ) | (48,536 | ) | ||||
| Total shareholders' equity | 16,627 | 5,648 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 21,657 | 10,239 |
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
| Six months ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| U.S. dollars in thousands (except per share data) | ||||||||
| Revenues | 2,073 | 1,855 | ||||||
| Cost of revenues | 880 | 698 | ||||||
| Gross profit | 1,193 | 1,157 | ||||||
| Research and development expenses | 2,730 | 1,434 | ||||||
| Sales and marketing expenses | 625 | 496 | ||||||
| General and administrative expenses | 1,584 | 846 | ||||||
| Operating loss | 3,746 | 1,619 | ||||||
| Financial expenses (income), net | 101 | (21 | ) | |||||
| Net loss and comprehensive loss | 3,847 | 1,598 | ||||||
| Basic and diluted net loss per share | 0.156 | 0.106 | ||||||
| Weighted average number of shares outstanding used in computing basic and diluted loss per share | 24,696,706 | 15,024,278 |
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
| Six months ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| U.S. dollars in thousands | ||||||||
| Cash flows from operating activities | ||||||||
| Net loss | (3,847 | ) | (1,598 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 50 | 26 | ||||||
| Share-based compensation | 184 | 137 | ||||||
| Exchange rate changes in cash and cash equivalents and short time deposits | 97 | 12 | ||||||
| Changes in assets and liabilities: | ||||||||
| Increase in trade accounts receivables | - | (153 | ) | |||||
| Increase in prepaid expenses and other receivables | (103 | ) | (205 | ) | ||||
| Increase in inventory | (401 | ) | (403 | ) | ||||
| Decrease in prepaid expenses and other long-term assets | - | 19 | ||||||
| Decrease (increase) in right of use assets | 19 | (117 | ) | |||||
| Increase in trade accounts payable | 159 | 19 | ||||||
| Increase (decrease) in lease liabilities | (59 | ) | 79 | |||||
| Increase in other current liabilities | 368 | 433 | ||||||
| Increase (decrease) in other long-term liabilities | (28 | ) | 909 | |||||
| Net cash used in operating activities | (3,561 | ) | (842 | ) | ||||
| Cash flows from investing activities | ||||||||
| Realization of deposits | 4,621 | - | ||||||
| Investment of long term deposits | (295 | ) | - | |||||
| Purchase of property and equipment | (247 | ) | (112 | ) | ||||
| Net cash provided by (used in) investing activities | 4,079 | (112 | ) | |||||
| Cash flows from financing activities | ||||||||
| Issuance of ordinary shares, net of issuance cost | 14,586 | - | ||||||
| Exercise of options to ordinary shares | 56 | 5 | ||||||
| Net cash provided by financing activities | 14,642 | 5 | ||||||
| Increase (decrease) in cash and cash equivalents | 15,160 | (949 | ) | |||||
| Cash and cash equivalents at beginning of the year | 3,502 | 5,789 | ||||||
| Effect of exchange rate fluctuations on balances of cash and cash equivalents | (49 | ) | (12 | ) | ||||
| Cash and cash equivalents at end of period | 18,613 | 4,828 |
Cryotherapy Solutions
IceCure Medical Ltd. | 7 Ha'Eshel St.,
Southern Industrial Park P.O.B. 316, Caesarea, 3079504, Israel
T: +972-4-602-0333 | F: +972-4-6230222