PORTLAND, Maine - ImmuCell Corporation (NASDAQ:ICCC), an animal health company, announced today that it is moving forward with the regulatory process for its new product, Re-Tain®, aimed at improving the health of dairy and beef cattle. The company has completed its fourth submission of the Chemistry, Manufacturing, and Controls (CMC) Technical Section to the U.S. Food and Drug Administration (FDA), responding to previous feedback.
The FDA has recently deemed ImmuCell's inspectional status as acceptable. The next step involves the company's contract manufacturer addressing its inspectional observations, which is expected to be completed by the end of June 2024. Clearing these observations is crucial for advancing the New Animal Drug Application (NADA) process.
ImmuCell's strategy is to streamline the review period by combining its next submission with other minor technical sections, potentially avoiding an additional 60-day review for an Administrative NADA submission. The company is hopeful for a shorter review period, as the responses to the CMC section are not complex. Upon FDA approval, ImmuCell plans a controlled launch with product expiration dating estimated between the second quarter of 2025 and the first quarter of 2026.
The President and CEO of ImmuCell, Michael F. Brigham, emphasized the company's focus on commercializing Re-Tain® while continuing to market their existing product, First Defense®. ImmuCell's Re-Tain® is being developed as a novel treatment for subclinical mastitis in dairy cows, which is notable for not requiring the FDA-mandated milk discard or meat withhold periods associated with traditional antibiotics.
This press release contains forward-looking statements, which are based on current management expectations and are subject to uncertainties and changes in circumstances. These statements do not guarantee future performance and are subject to risks, including delays in development, testing, regulatory approval, and market acceptance.
The information in this article is based on a press release statement from ImmuCell Corporation.
In other recent news, ImmuCell Corporation has reported a substantial increase in product sales, showcasing a 111% growth compared to the same period last year. The company's sales rose to $7.2 million in the first quarter of 2024, a significant boost attributed to an increase in production capacity.
Despite this sales growth, ImmuCell's gross margin improved to 32%, which is still below their target of 45%. The company also announced a delay in the regulatory approval process for its product, Retain.
Notably, ImmuCell's EBITDA turned positive at $377,000, marking a significant improvement from the negative $1.6 million recorded in the same quarter of the previous year. However, the company has yet to achieve a bottom line profit, and no specific projections for when they expect to turn a profit were provided.
These are recent developments for ImmuCell, which continues to focus on its key product, First Defense, aimed at treating subclinical mastitis in dairy cows. The company remains focused on improving gross margin dollars and is working on increasing production volume and controlling the process. Investors will be keenly watching the company's next earnings call scheduled for August, which will review the second-quarter results and provide further insights into ImmuCell's progress and strategies.
InvestingPro Insights
As ImmuCell Corporation (NASDAQ:ICCC) progresses with its regulatory journey for Re-Tain®, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, ImmuCell's market capitalization stands at $35.27 million. The company has shown robust revenue growth over the last twelve months as of Q1 2024, with a staggering quarterly increase of 110.58%. This suggests a strong market demand for the company's offerings, which could be further bolstered by the successful approval and launch of Re-Tain®.
Despite being in a development phase and not yet profitable, with a negative P/E ratio of -8.89, ImmuCell has managed to maintain a gross profit margin of 30.03%, indicating a solid underlying business model. This financial resilience is crucial as the company navigates the complex FDA approval process.
InvestingPro Tips highlight two essential aspects of ImmuCell's current financial status: firstly, the company's liquid assets surpass its short-term obligations, which is a positive sign of financial stability. Secondly, it's noteworthy that ImmuCell does not pay dividends to shareholders, which is typical for growth-focused companies reinvesting earnings into research and product development. In total, there are three additional InvestingPro Tips available for ImmuCell, offering deeper insights into the company's financial nuances.
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