Full Press Release Details
IceCure Medical Reports 2022 Full Year Financial
Corporate Developments; Milestone Achievements Expected to Drive Revenue Growth in 2023
CAESAREA, Israel, March 29, 2023 -- IceCure
Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) developer of the ProSense System of minimally-invasive cryoablation technology that destroys
tumors by freezing, today reported audited financial results as of and for the twelve months ended December 31, 2022.
"Our success throughout 2022 and the trends
we are currently experiencing position us to make significant commercial advances in key markets, including in the U.S., for the ProSense
platform for early-stage breast cancer and in China where our cryoprobes recently received approval for commercial use in combination
with our cryoablation system console, which was previously approved. Commercialization in China is driven by our exclusive distribution
agreement with Shanghai Medtronic Zhikang Medical Devices Co. Ltd., an affiliate of Medtronic ("Shanghai Medtronic Zhikang"),
the world's largest medical device company, which includes minimum purchase targets," stated Eyal Shamir, IceCure's
Chief Executive Officer. "We believe that our achievements in 2022, which included regulatory, reimbursement, clinical, and commercial
milestones, provide us with a solid foundation to execute our growth strategy to drive revenues in the years to come.
"Our rising confidence is bolstered by accelerated
sales of our disposable cryoprobes in the U.S., demonstrating that the previously installed ProSense systems are increasingly being utilized
by physicians. We also believe our strengthened balance sheet, which includes the $14.5 million we raised in December 2022, allows us
to expand our global marketing footprint. The capital resources we have will enable us to execute on our commercialization plans throughout
2023 and beyond while ensuring we can also invest in future generations of our novel technology."
Significant Operating, Clinical, Regulatory
& Commercial Highlights
Strengthened Balance Sheet
As of December 31, 2022, the Company had cash
and cash equivalents including short-term deposits of approximately $23.7 million, compared to approximately $25.6 million as of December
31, 2021. The Company will use its resources to execute its global business strategy and continue to raise awareness of the clinical and
economic benefits of its ProSense system.
Financial Results for the Twelve Months Ended
For the twelve months ended December 31, 2022,
the Company reported revenue of $3.1 million compared to revenue of $4.1 million for the twelve months ended December 31, 2021. As previously
disclosed on February 9, 2023, the year-over-year decline was due to lower revenue recognition of approximately $0.6 million from the
distribution agreements with Terumo Corporation and a decrease in sales of new systems, mostly in Thailand. This was partially offset
by higher revenue from sales of the Company's disposable probes, as previously sold and installed systems were utilized for procedures
in clinical settings, as well as higher sales in the U.S. compared to the prior year period.
Gross profit was approximately $1.4 million for
the twelve months ended December 31, 2022, compared to approximately $2.1 million for the twelve months ended December 31, 2021. Gross
margin was approximately 47% for the twelve months ended December 31, 2022, compared to approximately 53% for the twelve months ended
December 31, 2021. The decrease in gross margin compared to the same period last year was attributable to the decrease in revenue recognition
from the Terumo distribution agreements.
Research and development expenses for the twelve
months ended December 31, 2022, were approximately $9.1 million compared to approximately $5.9 million for the twelve months ended December
31, 2021. The increase was primarily due to the development of IceCure's next-generation single-probe system, along with increased clinical
and regulatory activities, including the FDA and NMPA submissions.
Sales and marketing expenses for the twelve months
ended December 31, 2022 were approximately $3.2 million, compared to approximately $1.9 million for the twelve months ended December 31,
2021. The increase was attributed to the Company's expanding commercialization efforts in the U.S. and other territories.
General and administrative expenses for the twelve
months ended December 31, 2022 were approximately $5.9 million, compared to approximately $4.1 million for the twelve months ended December
31, 2021. The increase was attributed to the Company's increased Nasdaq listing-related expenses.
Total operating expenses for the twelve months
ended December 31, 2022 were approximately $18.2 million, compared to approximately $11.9 million for the twelve months ended December
31, 2021. The increase in operating expenses was primarily attributable to increased development, commercialization, and Nasdaq listing-related
activities. As a result of lower revenue and increased operating activities, net loss reported for the twelve months ended December 31,
2022 increased to approximately $17.0 million, or $0.46 per share, compared with a net loss of approximately $9.9 million, or $0.35 per
share, for the same period last year.
Conference call information:
will discuss its results today via teleconference at 10:00 a.m. Eastern Time. To access the live call, dial 1-888-642-5032 (U.S.
toll-free) or +972-3-9180609 (International) and ask to join the IceCure earnings call. An
archived recording of the call will also be accessible on the "Investors" section of our website at www.icecure-medical.com.
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 FDA and approved in Europe with the CE Mark.
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 statement in this press release
when it discusses its positioning to make significant commercial advances in key markets, its ability
to execute its growth strategy and drive revenues, expected financial results and continued growth, the belief that the Company's achievements
provide it with a solid foundation to execute its growth strategy to drive revenues in the years to come,
its ability to expand its global marketing footprint and execute its commercialization plans, anticipating the FDA's response to
regulatory requests for approvals, the continued commercial rollout and commercial growth of its products, pursuit of and timing for regulatory
approvals in various jurisdictions, its strategic plans, and expansion of clinical applications and potential market adoption of its minimally-invasive
cryoablation technology. 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 April
1, 2022, 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
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share
data and per share data)
| As of December 31, | As of December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | 23,659 | 25,621 | ||||||
| Restricted deposit | 296 | - | ||||||
| Trade accounts receivable | 78 | 456 | ||||||
| Inventory | 2,857 | 1,955 | ||||||
| Prepaid expenses and other receivables | 1,240 | 2,290 | ||||||
| Total current assets | 28,130 | 30,322 | ||||||
| NON-CURRENT ASSETS | ||||||||
| Right of use assets | 668 | 913 | ||||||
| Property and equipment, net | 1,356 | 713 | ||||||
| Prepaid expenses and other long-term assets | 34 | 333 | ||||||
| Total non-current assets | 2,058 | 1,959 | ||||||
| TOTAL ASSETS | 30,188 | 32,281 | ||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Trade accounts payable | 714 | 881 | ||||||
| Lease liabilities | 167 | 224 | ||||||
| Other current liabilities | 3,455 | 2,915 | ||||||
| Total current liabilities | 4,336 | 4,020 | ||||||
| NON-CURRENT LIABILITIES | ||||||||
| Long term lease liabilities | 430 | 685 | ||||||
| Other long-term liabilities | - | 618 | ||||||
| Total non-current liabilities | 430 | 1,303 | ||||||
| Commitments and contingencies | ||||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and outstanding: 45,623,434 shares and 35,780,335 shares as of December 31, 2022 and December 31, 2021, respectively | - | - | ||||||
| Pre-funded warrants to ordinary shares, Issued and outstanding: zero Pre-funded warrants and 1,034,000 Pre-funded warrants as of December 31, 2022 and December 31, 2021, respectively | - | - | ||||||
| Additional paid-in capital | 100,831 | 85,389 | ||||||
| Accumulated deficit | (75,409 | ) | (58,431 | ) | ||||
| Total shareholders' equity | 25,422 | 26,958 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 30,188 | 32,281 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
(U.S. dollars in thousands, except share
data and per share data)
| Year ended December 31, | Year ended December 31, | |||||||
| 2022 | 2021 | |||||||
| Revenues | 3,085 | 4,138 | ||||||
| Cost of revenues | 1,640 | 1,943 | ||||||
| Gross profit | 1,445 | 2,195 | ||||||
| Research and development expenses | 9,123 | 5,877 | ||||||
| Sales and marketing expenses | 3,204 | 1,917 | ||||||
| General and administrative expenses | 5,857 | 4,125 | ||||||
| Operating loss | 16,739 | 9,724 | ||||||
| Financial expenses (income), net | 239 | 171 | ||||||
| Net loss and comprehensive loss | 16,978 | 9,895 | ||||||
| Basic and diluted net loss per share | 0.46 | 0.35 | ||||||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 37,016,631 | 28,548,676 |
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands, except share
data and per share data)
| Year ended December 31, | Year ended December 31, | |||||||
| 2022 | 2021 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | (16,978 | ) | (9,895 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 248 | 127 | ||||||
| Share-based compensation | 1,865 | 316 | ||||||
| Exchange rate changes in cash and cash equivalents and deposit | 359 | 5 | ||||||
| Changes in assets and liabilities: | ||||||||
| Decrease (increase) in trade accounts receivable | 378 | (362 | ) | |||||
| Increase in inventory | (902 | ) | (891 | ) | ||||
| Decrease (increase) in prepaid expenses and other receivables | 1,050 | (2,030 | ) | |||||
| Decrease in prepaid expenses and other long- term assets | - | - | ||||||
| Decrease (increase) in right of use assets | 245 | (607 | ) | |||||
| Increase (decrease) in trade accounts payable | (167 | ) | 236 | |||||
| Increase (decrease) in lease liabilities | (312 | ) | 577 | |||||
| Increase (decrease) in other current liabilities | 540 | 60 | ||||||
| Increase (decrease) in other long-term liabilities | (618 | ) | (141 | ) | ||||
| Net cash used in operating activities | (14,292 | ) | (12,605 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Realization of (Investment in) deposits | - | 4,621 | ||||||
| Investment of restricted deposits | - | (296 | ) | |||||
| Purchase of property and equipment | (891 | ) | (533 | ) | ||||
| Net cash provided by (used in) investing activities | (891 | ) | 3,792 | |||||
| Cash flows from financing activities: | ||||||||
| Issuance of ordinary shares, net of issuance costs | 13,569 | 14,586 | ||||||
| Issuance of restricted ordinary shares | 6 | - | ||||||
| Issuance of ordinary shares and pre- funded warrants, net of issuance costs | - | 15,966 | ||||||
| Exercise of pre- funded warrants | 1 | - | ||||||
| Exercise of options to ordinary shares | 1 | 337 | ||||||
| Net cash provided by financing activities | 13,577 | 30,889 | ||||||
| Increase (decrease) in cash and cash equivalents | (1,606 | ) | 22,076 | |||||
| Cash and cash equivalents beginning of the year | 25,621 | 3,502 | ||||||
| Effect of foreign exchange rate on cash and cash equivalents | (356 | ) | 43 | |||||
| Cash and cash equivalents end of the year | 23,659 | 25,621 |