IceCure Medical Reports 36% Sales Growth in the First Nine Months of 2024 Driven by Global Adoption of ProSense$(R)$ Cryoablation
PR Newswire
CAESAREA, Israel, Nov. 26, 2024
FDA Marketing Authorization Decision on Early Stage-Low Risk Breast Cancer Expected in Q1 2025
Conference call to be held today at 10:00 am Eastern Time
CAESAREA, Israel, Nov. 26, 2024 /PRNewswire/ -- 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 nine months ended September 30, 2024. Sales of ProSense(R) consoles and disposable probes increased by 36%. Gross profits increased by 41%, while non-GAAP gross profits grew by 104%. Gross margins increased to 43%, while non-GAAP gross margin increased to 40%, compared to 27% in the same period in 2023].
On November 7, 2024, the U.S. Food and Drug Administration's ("FDA") Medical Device Advisory Committee Panel (the "Advisory Panel") voted in favor of ProSense(R)'s benefit-risk profile in early-stage low risk breast cancer.
Near-Term Value Enhancing Catalysts
-- The FDA will review and evaluate the Advisory Panel's recommendation and
is expected to make a final decision regarding marketing authorization
of ProSense(R) in early-stage, low risk breast cancer with endocrine
therapy in the first quarter of 2025.
-- Interim results of the Company's ICESECRET, a prospective, multicenter,
single-arm clinical trial of ProSense(R) for the cryoablation of kidney
cancer, are expected to be released in December 2024.
-- Terumo Corporation, IceCure's partner in Japan, is expected to file for
regulatory approval of ProSense(R) for breast cancer in Japan in 2025,
with the aim of receiving regulatory clearance.
-- The Company expects that additional third-party data on ProSense(R) will
be published in medical journals and presented at prestigious medical
conferences throughout 2025.
"While our efforts have remained focused on the U.S. marketing authorization for ProSense(R) in early-stage breast cancer, the impressive 36% sales growth for the first nine months ended September 30, 2024, compared to the same period last year, demonstrates our commitment to working with our global partners to accelerate the adoption and increase the utilization of ProSense(R)," stated IceCure Medical's CEO, Eyal Shamir. "As we near the end of 2024, it goes without saying that it is shaping up to be a transformative year for IceCure. We successfully completed the ICE3 trial and published top line data. Furthermore, the positive outcome of the FDA Advisory Panel earlier this month brings us to the cusp of potential marketing authorization, which, if received, would allow us to offer women a non-surgical alternative to lumpectomy. We believe, based on current global sales growth and further awareness, understanding, and education of ProSense(R), our cryoablation system will be an indispensable tool for breast surgeons, interventional radiologists and interventional oncologists, and patients alike."
"The FDA Advisory Panel meeting further elevated the awareness of ProSense(R) and our goal upon the FDA reaching its decision is to build out the sales infrastructure and footprint to meet expected demand," Shamir concluded.
Large Body of Published Data on ProSense(R)'s Efficacy & Safety Continues to Grow
The following is a list of published studies during and subsequent to the third quarter:
-- IceCure's ICE3 5-Year trial results were published in the peer-reviewed
Annals of Surgical Oncology Journal: "ProSense(R) cryoablation without
excision for early-stage, low-risk breast cancer demonstrates 96.3%
recurrence free rate."
-- Study published in the British Journal of Radiology demonstrates
ProSense(R) is a safe procedure with 97.7% technical success rate for
cryoablation of tumors of the lung, bone, and soft tissues.
-- Largest multi-institutional study of its kind: "Cryoablation of Primary
Breast Cancer in Patients Ineligible for Clinical Trials" reports
positive data; published in the American Journal of Roentgenology.
-- ProSense(R) destroyed 100% of breast cancer tumors per an independent
study of patients who chose cryoablation instead of surgery; published in
the British Journal of Radiology.
-- European study provides more evidence supporting ProSense(R) cryoablation
for metastatic and recurrent breast cancer; published in highly
influential peer-reviewed journal, Cancers.
-- 99.74% recurrence free rate for women with breast cancer who underwent
cryoablation with ProSense(R) in Japan; presented at 32nd Annual Meeting
of the Japanese Breast Cancer Society.
-- ProSense(R) featured in six global studies on cryoablation of breast
tumors at the 2024 European Society of Breast Imaging Conference:
-- Image guided cryoablation for low-risk breast cancers: results and
imaging findings of the ICE3 trial.
-- The treatment of breast cancer with percutaneous thermal ablation:
results of the THERMAC trial in the Netherlands.
-- The treatment of breast cancer with percutaneous thermal ablation:
cosmetic outcome and patient satisfaction in the Netherlands.
-- Assessment of pain level and quality of life in breast cancer
patients treated with ultrasound-guided cryoablation in Italy.
-- Single-center experience with percutaneous cryoablation for benign
and malignant breast lesions in Romania: tumor reduction and
safety.
-- Single center experience with percutaneous cryoablation of
fibroadenomas in Hungary: volume reduction and safety.
An article published in the European Journal of Cancer Prevention on November 6, 2024 outlines the recently launched PRECICE study which will exclusively use ProSense(R) for the study of cryoablation of early stage, low risk breast cancer - an independent prospective observational study of 233 women aged 50 and older with unifocal, small, clinically node-negative, luminal A and B breast cancer at the prestigious European Institute of Oncology in Milan, Italy.
Financial Results for the Nine Months Ended September 30, 2024 Demonstrate Accelerating Growth of ProSense(R) Adoption and Utilization
Sales of ProSense(R) systems and disposable probes for the nine months ended September 30, 2024 increased by 36% to $2,316,000 compared to $1,700,000 for the nine months ended September 30, 2023. The growth was primarily attributable to sales in Europe, the U.S., Japan and other territories in Asia which were partially offset by a decrease in sales in China. Total revenue for the nine months ended September 30, 2024 increased by 22% to $2,416,000 from $1,974,000 for the nine months ended September 30, 2023 due to an increase in the sale of ProSense(R) systems and disposables, which was partially offset by a decrease in revenue recognition and other services in Japan of $100,000 and $274,000 in the first nine months of 2024 and 2023, respectively.
Gross profit for the nine months ended September 30, 2024 increased by 41% to $1,034,000 from $731,000 for the nine months ended September 30, 2023. Non-GAAP gross profit more than doubled for the nine months ended September 30, 2024 to $934,000 from $457,000 for the nine months ended September 30, 2023, an increase of $477,000 or 104%. Gross margin increased to 43% in the nine months ended September 30, 2024 compared to 37% in the nine months ended September 30, 2023. Non-GAAP gross margin for the nine months ended September 30, 2024 increased to 40% from 27% for the nine months ended September 30, 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 36% in revenue from sales of ProSense(R) systems and disposables. 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 GAAP measure, see Appendix A to this press release.
Research and development expenses for the nine months ended September 30, 2024 decreased by 15% to $5,401,000 compared to $6,390,000 for the nine months ended September 30, 2023. The decrease was primarily due to a reduction in development expenses for the XSense$(TM)$ 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 nine months ended September 30, 2024 to $4,041,000 compared to $3,234,000 for the nine months ended September 30, 2023 as the Company focused on increased global marketing to support growing sales and in anticipation of potential marketing authorization for ProSense(R) in early-stage breast cancer in the U.S. General and administrative expenses for the nine months ended September 30, 2024 decreased to $2,763,000 from $3,268,000 for the nine months ended September 30, 2023, reflecting the Company's continued prudent budgeting and operating efficiencies.
Total operating expenses for the nine months ended September 30, 2024 decreased to $12,205,000 from $12,892,000 for the nine months ended September 30, 2023. The decrease in operating expenses was attributable to reductions in research and development and general and administrative expenses, due to the Company's initiative to reduce non-critical operating expenses, which were partially offset by an increase in sales and marketing expenses.
(MORE TO FOLLOW) Dow Jones Newswires
November 26, 2024 08:30 ET (13:30 GMT)
Comments