Exhibit 99.1
IceCure Medical Reports Financial Results as of and for the first Nine Months of 2021 and Recent Corporate Developments
CAESAREA, Israel, November 23, 2021 -- IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” or the “Company”), developer of next-generation, minimally-invasive cryoablation technology with ProSense® that destroys tumors by freezing as an alternative to surgical tumor removal, today reported its financial results as of and for the nine-month period ended September 30, 2021.
Recent Corporate Developments
| ● | On September 13th, IceCure announced the first peer-reviewed article of its ICE3 Clinical Trial “Cryoablation Without Excision for Low-Risk, Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial”. The article was published in the Annals of Surgical Oncology by the lead author Dr. Richard Fine, M.D., FACS, an ICE3 investigator who serves as Program Director of the Breast Surgical Oncology Fellowship and as Director of Research and Education at the West Comprehensive Breast Center in Germantown, Tennessee, as the lead author. |
| ● | On October 12th, the Company submitted an amendment to the registration certificate for the IceSense3® system to China’s National Medical Products Administration (“NMPA”), which, if approved, would allow the disposable IceSense3 Cryoprobes to be sold for commercial procedures in mainland China. Approval of the amendment is expected by the end of 2022, which would be followed by a commercial sales program launch in China in early 2023. |
| ● | On October 20th, IceCure announced an expansion of the Company’s global distribution network with an initial distribution agreement in Poland with Mobile SCANMED Systems SP. z o.o. (“Mobile SCANMED Systems”) to exclusively sell the ProSense® Cryoablation System and disposables. |
| ● | On November 1st, the Company announced a peer-reviewed publication, “VAB and MRI Following Percutaneous Ultra-Sound Guided Cryoablation for Primary Early-Stage Breast Cancer: A Pilot Study in Japan”, that was published in the Journal of Cancer Therapy by lead author Dr. Hisanori Kawamoto, M.D., Ph.D. from the Department of Breast Surgery Breast and Imaging Center, St. Marianna University School of Medicine, Japan. The published data from the independent study demonstrated that percutaneous cryoablation presents a potential substitute for lumpectomy of breast tumors <15mm using ProSense. |
“This is an exciting time in IceCure’s history, as we continue to generate increasing interest among a growing roster of leading commercial partners around the world to distribute our ProSense Cryoablation System, including forming recent distribution collaborations in Poland, Turkey, India, Brazil and various countries across Asia. This burgeoning interest speaks directly to the potential of our cryoablation system to provide a solution to the significant market demand for minimally-invasive, safe and effective alternatives to surgical tumor removal,” stated Eyal Shamir, Chief Executive Officer of IceCure.
Innovating 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 | www.icecure-medical.com
4888-2699-5204, v.2
Mr. Shamir continued, “In addition, we are steadily making progress advancing our regulatory and commercial strategies within the world’s largest oncology markets, including the U.S., China and the EU. In the U.S., the ICE3 trial is the largest controlled multi-center clinical trial for freezing of small, low-risk, early-stage breast tumors with liquid nitrogen, and we are working towards establishing a regulatory path that is expected to make the ProSense System available as a minimally invasive treatment to early-stage breast cancer patients and breast cancer patients that are considered high-risk for undergoing surgery. In China, we recently announced an update to our strategy for initiating commercial sales for our cryoablation therapy system, pending regulatory approval by the NMPA of an amendment to the registration certificate for the IceSense3 system.”
Financial Results for the Nine-Month Period Ended September 30, 2021
For the nine months ended September 30, 2021, revenue increased by 11% to approximately $2.75 million, compared to approximately $2.49 million for the nine months ended September 30, 2020.
Gross profit was $1.55 million for the nine months ended September 30, 2021, compared to $1.6 million for the nine months ended September 30, 2020. Gross margin was 56% for the nine-month period ended September 30, 2021, compared to 64% for the nine months ended September 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, sales to distributors instead of direct sales to end customers and increase in costs.
Total operating expenses for the nine months ended September 30, 2021 were approximately $8.15 million, compared to approximately $4.56 million for the nine months ended September 30, 2020. The increase in operating expenses is primarily attributable to the development of the Company’s next generation cryoablation systems and probes and the Nasdaq-listing-related expenses.
As a result of the increase in the Company’s expenses, net loss reported for the nine-month period ended September 30, 2021 increased to approximately $6.73 million, or $0.25 per share, compared to a net loss of approximately $2.95 million, or $0.20 per share, for the same period last year.
As of September 30, 2021, the Company had cash and cash equivalents and deposits of approximately $15.4 million, compared to approximately $8.2 million as of December 31, 2020. The $7.2 million increase includes $15 million in gross proceeds raised in 2021 through a private placement investment in the Company’s shares.
Innovating 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 | www.icecure-medical.com
4888-2699-5204, v.2
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About IceCure Medical
Founded 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 approved to-date by FDA and the European CE Mark.
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 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 and IceSence3 system, commercialization activities and the market opportunity for the Company’s ProSense Cryoablation System. 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 (as amended, the “Form F-1”). Copies of the Form F-1 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:
Chuck Padala
LifeSci Advisors
o: +1 646-627-8390 / c: +1 917-741-7792
email: chuck@lifesciadvisors.com
Innovating 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 | www.icecure-medical.com
4888-2699-5204, v.2
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ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| As of September 30, 2021 | As of December 31, 2020 | |||||||
| (Unaudited) | (Audited) | |||||||
| U.S. dollars in thousands | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | 15,385 | 3,502 | ||||||
| Deposit | - | 4,669 | ||||||
| Trade accounts receivables | 87 | 94 | ||||||
| Inventory | 1,774 | 1,064 | ||||||
| Prepaid expenses and other receivables | 494 | 260 | ||||||
| Total current assets | 17,740 | 9,589 | ||||||
| NON-CURRENT ASSETS | ||||||||
| Prepaid expenses and other long-term assets | 332 | 37 | ||||||
| Right-of-use assets | 1,029 | 306 | ||||||
| Property and equipment, net | 576 | 307 | ||||||
| Total non-current assets | 1,937 | 650 | ||||||
| TOTAL ASSETS | 19,677 | 10,239 | ||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Trade accounts payable | 839 | 645 | ||||||
| Lease liabilities | 194 | 214 | ||||||
| Other current liabilities | 3,492 | 2,855 | ||||||
| Total current liabilities | 4,525 | 3,714 | ||||||
| NON-CURRENT LIABILITIES | ||||||||
| Long-term lease liabilities | 817 | 118 | ||||||
| Other long-term liabilities | 519 | 759 | ||||||
| Total non-current liabilities | 1,336 | 877 | ||||||
| Total liabilities | 5,861 | 4,591 | ||||||
| SHAREHOLDERS’ EQUITY | ||||||||
| Ordinary shares, No par value; Authorized 2,500,000,000 shares; Issued and outstanding: 31,877,495 shares and 20,218,220 shares as of September 30, 2021 and December 31, 2020, respectively | ||||||||
| Treasury shares | - | (41 | ) | |||||
| Additional paid-in capital | 69,087 | 54,225 | ||||||
| Accumulated deficit | (55,271 | ) | (48,536 | ) | ||||
| Total shareholders’ equity | 13,816 | 5,648 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 19,677 | 10,239 | ||||||
Innovating 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 | www.icecure-medical.com
4888-2699-5204, v.2
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ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
Nine months ended September 30, | ||||||||
| 2021 | 2020 | |||||||
U.S. dollars in thousands (except per share data) | ||||||||
| Revenues | 2,754 | 2,490 | ||||||
| Cost of revenues | 1,202 | 892 | ||||||
| Gross profit | 1,552 | 1,598 | ||||||
| Research and development expenses | 4,276 | 2,439 | ||||||
| Sales and marketing expenses | 1,217 | 831 | ||||||
| General and administrative expenses | 2,655 | 1,289 | ||||||
| Operating loss | 6,596 | 2,961 | ||||||
| Financial expenses (income), net | 139 | (14 | ) | |||||
| Net loss and comprehensive loss | 6,735 | 2,947 | ||||||
| Basic and diluted net loss per share | 0.249 | 0.196 | ||||||
| Weighted average number of shares outstanding used in computing basic and diluted loss per share | 27,098,847 | 15,029,168 | ||||||
Innovating 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 | www.icecure-medical.com
4888-2699-5204, v.2
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ICECURE MEDICAL LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
Nine months ended September 30, | ||||||||
| 2021 | 2020 | |||||||
| U.S. dollars in thousands | ||||||||
| Cash flows from operating activities | ||||||||
| Net loss | (6,735 | ) | (2,947 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 86 | 42 | ||||||
| Share-based compensation | 254 | 205 | ||||||
| Exchange rate changes in cash and cash equivalents and short time deposits | 74 | 26 | ||||||
| Changes in assets and liabilities: | ||||||||
| Decrease (increase) in trade accounts receivables | 7 | (216 | ) | |||||
| Increase in prepaid expenses and other receivables | (234 | ) | (303 | ) | ||||
| Increase in inventory | (710 | ) | (471 | ) | ||||
| Decrease in prepaid expenses and other long-term assets | - | 400 | ||||||
| Increase in right of use assets | (723 | ) | (123 | ) | ||||
| Increase (decrease) in trade accounts payable | 194 | (132 | ) | |||||
| Increase in lease liabilities | 679 | 90 | ||||||
| Increase in other current liabilities | 637 | 447 | ||||||
| Increase (decrease) in other long-term liabilities | (240 | ) | 663 | |||||
| Net cash used in operating activities | (6,711 | ) | (2,319 | ) | ||||
| Cash flows from investing activities | ||||||||
| Realization of deposits (Investment of deposits) | 4,621 | (4,432 | ) | |||||
| Investment of long term deposits | (295 | ) | - | |||||
| Purchase of property and equipment | (355 | ) | (159 | ) | ||||
| Net cash provided by (used in) investing activities | 3,971 | (4,591 | ) | |||||
| Cash flows from financing activities | ||||||||
| Issuance of ordinary shares, net of issuance cost | 14,586 | 5,847 | ||||||
| Exercise of options to ordinary shares | 63 | 11 | ||||||
| Net cash provided by financing activities | 14,649 | 5,858 | ||||||
| Increase (decrease) in cash and cash equivalents | 11,909 | (1,052 | ) | |||||
| 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 | (26 | ) | 46 | |||||
| Cash and cash equivalents at end of period | 15,385 | 4,783 | ||||||
Innovating 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 | www.icecure-medical.com
4888-2699-5204, v.2
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