IceCure Medical Reports First Quarter 2023 Financial & Operational Results

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22 May, 2023, 08:00 ET

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CAESAREA, Israel, May 22, 2023 /PRNewswire/-- 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 Highlights

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

US: 1-888-642-5032

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: https://ir.icecure-medical.com/news-events/events-presentations

About IceCure Medical Ltd.

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.

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 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 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.

IR Contact:Michael PolyviouEmail: [email protected]

Todd KehrliEmail: [email protected]

ICECURE MEDICAL LTD.

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

As ofMarch 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

Trade accounts receivables

143

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

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 (Unaudited)

Three months endedMarch 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)

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 (Unaudited)

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

Share-based compensation

356

450

Exchange rate changes in cash and cash equivalents and short time deposits

Changes in assets and liabilities:

Decrease (increase) in trade accounts receivables

(65)

Decrease in prepaid expenses and other receivables

374

728

Increase in inventory

(71)

(369)

Decrease in right of use assets

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

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SOURCE IceCure Medical

IceCure Medical