Full Press Release Details
IceCure Medical Reports 2024 Financial Results:
42% Growth in ProSense Cryoablation Sales in North America
Expecting FDA decision on marketing authorization
for early-stage low risk breast cancer with endocrine therapy
Positive ProSense results were reported
through 33 peer-reviewed journals and medical conferences during 2024
Conference call to be held today at 10:00 am
CAESAREA, Israel, March 27, 2025 -
IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of
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 twelve months ended December 31, 2024.
IceCure continues to engage with the U.S. Food
and Drug Administration ("FDA") regarding its De Novo marketing authorization request for ProSense in early-stage low
risk breast cancer with endocrine therapy. Should ProSense receive marketing authorization in this indication, ProSense would
become a first-in-class minimally invasive alternative to standard of care lumpectomy.
"The sales momentum we have experienced
in 2024 for ProSense in North America, as well as in Europe and Japan, are encouraging signs that a positive marketing clearance
outcome in the U.S. may lead to a higher adoption of ProSense . Early interest in the U.S. for breast cancer cryoablation is evident
following the favorable decision of the FDA Medical Device Advisory Panel ("Advisory Panel") in November 2024," stated
IceCure Medical's CEO, Eyal Shamir.
"We continue to see adoption of ProSense
cryoablation in numerous indications across the globe. This traction is evident through 33 investigator-initiated studies presented and
published during 2024," Shamir added.
Upcoming 2025 Catalysts
Financial Results for the Twelve Months Ended
December 31, 2024 Demonstrate Accelerating Growth of ProSense Adoption and Utilization
systems and disposable probes for the twelve months ended December 31, 2024 increased to $3,191,000 compared to $2,955,000 for the
twelve months ended December 31, 2023. The growth was primarily attributable to sales in North America, as well as increases in Japan
and other territories in Asia and Europe, partially offset by a decrease in sales in China and Latin America. Total revenue for the twelve
months ended December 31, 2024 increased to $3,291,000 from $3,229,000 for the twelve months ended December 31, 2023, primarily due
to an increase in product sales, which was partially offset by a decrease in revenue recognition and other services in Japan of $100,000
and $274,000 in the twelve months of 2024 and 2023, respectively.
the twelve months ended December 31, 2024 increased by 12% to $1,451,000 from $1,300,000 for the twelve months ended December 31,
2023. Gross margin increased to 44% in the twelve months ended December 31, 2024 compared to 40% in the twelve months ended December 31,
2023. The increase in gross profit and gross margin was attributable to an 8% increase in revenue from product sales. Non-GAAP gross profit
for the twelve months ended December 31, 2024 increased to $1,351,000 from $1,026,000 for the twelve months ended December 31, 2023, an
increase of $325,000 or 32%. Non-GAAP gross margin for the twelve months ended December 31, 2024 increased to 42% from 35% for the twelve
months ended December 31, 2023. The increase in non-GAAP gross profit and non-GAAP gross margin, which exclude revenue from the exclusive
distribution agreements and other services in Japan, was attributable to the increase of 8% in revenue from product sales. Non-GAAP gross
profit and non-GAAP gross margin are financial measures that may be defined as "non-GAAP financial measures" by the U.S. Securities
and Exchange Commission ("SEC"). For a reconciliation of these non-GAAP financial measures to the nearest comparable measure
calculated in accordance with generally accepted accounting principles in the U.S. ("GAAP"), see Appendix A to this press
Research and development
expenses for the twelve months ended December 31, 2024 decreased by 14% to $7,096,000 compared to $8,273,000 for the twelve
months ended December 31, 2023. The decrease was primarily due to a reduction in development expenses for the XSense System, which
received FDA authorization in June 2024, and a decrease in clinical and regulatory costs as the Company concluded the ICE3 study in March
2024. Sales and marketing expenses increased for the twelve months ended December 31, 2024 by 42% to $6,296,000 compared to $4,437,000
for the twelve months ended December 31, 2023 as the Company focused on increased global marketing to support growing sales and in anticipation
of potential marketing authorization for ProSense in early-stage breast cancer in the U.S. General and administrative expenses for
the twelve months ended December 31, 2024 decreased by 10% to $3,755,000 from $4,166,000 for the twelve months ended December 31,
2023, reflecting the Company's continued prudent budgeting and operating efficiencies.
Total operating expenses
for the twelve months ended December 31, 2024 increased by 2% to $17,147,000 from $16,876,000 for the twelve months ended December 31,
2023. The increase in operating expenses was attributable to an increase in sales and marketing expenses, which were partially offset
by reductions in research and development and general and administrative expenses, due to the Company's initiative to reduce non-critical
Net loss for the twelve
months ended December 31, 2024 increased by 5% to $15,318,000, or $0.30 per share, compared to a net loss of $14,652,000,
or $0.32 per share, for the same period last year.
2024, the Company had cash and cash equivalents, including short-term deposits, of approximately $7.6 million. As of March 24, 2025,
the Company had cash and cash equivalents of approximately $6.0 million. Between January 13, 2025 and March 24, 2025, the Company raised
$2.6 million in net proceeds from the sale of 2,047,277 ordinary shares under its at-the-market offering facility.
Use of Non-U.S. GAAP Measures
In addition to disclosing financial results prepared
in accordance with U.S. GAAP, this press release contains certain financial measures which may be defined as "non-GAAP financial
measures" by the SEC. The Company defines non-GAAP gross profit as gross profit less revenue from exclusive distribution agreements
and other services. The Company has provided non-GAAP gross profit in this press release because it is a key measure used by management
and the board of directors as an indication of our gross profit from sales of our systems and disposables and management believes that
it is useful to investors' understanding and assessment of the Company's gross profit without the impact of revenue recorded
from the Company's exclusive distribution agreements and other services. The Company has provided a reconciliation below of non-GAAP
gross profit and non-GAAP gross margin to the most directly comparable financial measure calculated and presented in accordance with U.S.
GAAP. The non-GAAP financial measures disclosed by the Company should not be considered in isolation or as a substitute for, or superior
to, financial measures calculated in accordance with U.S. GAAP and the financial results calculated in accordance with U.S. GAAP and reconciliations
to those financial results should be carefully evaluated.
Conference call & webcast info:
Thursday, March 27, 2025, at 10:00 am EDT
Israel/International: +972-3-918-0696
A live webcast will be available at: https://Veidan.activetrail.biz/IcecureQ4-2024
A recording of the webcast will be available at:
ir.icecure-medical.com/
The ProSense Cryoablation System provides
a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to
create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and
ProSense enhances patient and provider value
by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization,
ProSense opens that door to fast and convenient office-based procedure for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets
advanced liquid-nitrogen-based cryoablation therapy systems 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 Company's flagship ProSense system is
marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.
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 statements in this press release when it discusses: prospective FDA De Novo
marketing authorization for ProSense in early-stage low risk breast cancer with endocrine therapy; the belief that sales data from North
America, Europe and Japan may show that a positive marketing clearance outcome in the U.S. may lead to higher adoption of ProSense ;
the belief that marketing authorization of ProSense in the U.S. is expected to drive further sales momentum in global markets; the expected