On Wednesday, H.C. Wainwright adjusted its stock price target for IceCure Medical Ltd. (NASDAQ:ICCM), reducing it to $2.50 from the previous $3.00, but maintained a Buy rating on the stock. The firm's decision followed the release of IceCure Medical's second-quarter financial results for the fiscal year 2024.
The company reported a total revenue of $1.0 million, which is an 8% year-over-year growth and surpasses the projected $0.9 million. The net loss recorded was $3.1 million, or ($0.08) per share, which was below the anticipated loss of $3.6 million.
IceCure Medical experienced a notable 20% increase in sales of its ProSense systems and disposable probes, amounting to $1.7 million in the first half of 2024, up from $1.4 million in the same period of the previous year. This growth was attributed to robust sales across Europe, the U.S., Japan, and other Asian territories, despite a decline in sales within China.
The company's management is anticipating a significant event in the fourth quarter of 2024, where the FDA is expected to convene a medical device advisory committee panel meeting to discuss ProSense, particularly for the treatment of early-stage T1 invasive breast cancer using cryoablation and adjuvant hormone therapy. The advisory committee will provide independent expert advice on various matters concerning ProSense.
H.C. Wainwright highlighted the potential of IceCure Medical's minimally invasive ProSense cryoablation procedure to supplant lumpectomy, which is currently the standard care for the relevant patient demographic, estimated at 65,000 individuals annually in the U.S. The FDA's final decision on the De Novo marketing clearance application for ProSense is expected in early 2025.
Furthermore, IceCure Medical is preparing to present interim data from its ICESECRET study, which investigates the use of ProSense in treating kidney cancer, by December 2024. Moreover, Terumo, IceCure's partner in Japan, intends to seek regulatory approval for ProSense for the treatment of early-stage low-risk breast cancer with endocrine therapy in Japan in the first quarter of 2025.
In other recent news, IceCure Medical, a developer of cryoablation technology, has reported a 20% year-over-year sales growth for its ProSense system and disposable probes in the financial results for the six months ended June 30, 2024.
The company maintained a consistent gross profit of 46% and improved its net loss to $6.7 million. IceCure Medical also raised $5.035 million in gross proceeds from the sale of ordinary shares in the first half of 2024.
In addition to financial performance, the company anticipates significant regulatory events, including an interim analysis of the ICESECRET kidney cancer trial and an FDA advisory panel meeting for ProSense's use in early-stage breast cancer. These are among the recent developments that investors may find noteworthy.
Furthermore, IceCure Medical is preparing for major catalysts, including an FDA advisory panel in Q4 2024 and an FDA marketing clearance decision in Q1 2025. The company is also focusing on breast cancer treatment in the US and is working towards approval in Japan with Terumo. Lastly, independent studies on breast cancer and other indications are ongoing, with more data expected in the rest of 2024 and early 2025.
InvestingPro Insights
As IceCure Medical Ltd. (NASDAQ:ICCM) navigates through its pivotal phase, keeping a close eye on its financial health and market performance is crucial. InvestingPro data reveals a market capitalization of $36.17M, indicating a relatively small but potentially agile player in the medical device sector.
Despite a negative P/E ratio of -2.18, which reflects the company's current lack of profitability, analysts remain optimistic about its sales growth, as evidenced by the 7.02% year-over-year revenue increase reported in the last twelve months as of Q1 2024.
InvestingPro Tips highlight that IceCure Medical holds more cash than debt, providing it with a buffer to fund operations and invest in growth opportunities. Moreover, the company has liquid assets that exceed its short-term obligations, suggesting a degree of financial flexibility in the near term.
However, analysts do not expect the company to be profitable this year, aligning with the negative operating income margin of -468.09%. Despite this, the stock has experienced a significant return over the last week, with a 27.9% price total return, which could capture the interest of investors looking for short-term gains in volatile markets.
For investors interested in a deeper dive into IceCure Medical's financials and market prospects, there are 10 additional InvestingPro Tips available at https://www.investing.com/pro/ICCM, which could provide further insights into the company's performance and potential trajectory.
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