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Immucell - ICCC STOCK NEWS

Welcome to our dedicated page for Immucell news (Ticker: ICCC), a resource for investors and traders seeking the latest updates and insights on Immucell stock.

Company Overview

ImmuCell Corporation (ICCC) is a biotechnology firm headquartered in Portland, Maine, dedicated to enhancing the health and productivity of dairy and beef cattle. The company leverages scientific research to develop and manufacture innovative animal health products. With a strong focus on measurable and economical improvements in livestock performance, ImmuCell operates at the intersection of biotechnology and veterinary health, delivering solutions that are both scientifically proven and practically effective.

Business Segments and Product Offerings

ImmuCell operates through two primary business segments, each addressing distinct challenges in the livestock industry:

  • Scours Segment: This segment is centered on products used to prevent scours in newborn calves. The company's flagship solution in this area offers immediate immunity to calves, ensuring that they receive essential protection during the early stages of life. This not only supports animal health but also contributes to enhanced productivity and reduced economic losses in both dairy and beef operations.
  • Mastitis Segment: Focused on addressing subclinical mastitis in lactating dairy cows, this segment is driven by the development and commercialization of novel treatment solutions. The product under development in this segment distinguishes itself by providing an alternative to traditional antibiotics, offering a practical option with no requirement for milk discard. Regulatory oversight from agencies such as the FDA ensures that these products meet rigorous standards for safety and efficacy.

Regulatory Environment and Industry Standards

Operating in a highly regulated space, ImmuCell adheres to strict guidelines set forth by agencies including the United States Department of Agriculture (USDA) and the United States Food and Drug Administration (FDA). This regulatory framework not only guides the product development process but also reinforces the credibility and reliability of its scientific claims. By continuously engaging with these regulatory bodies and addressing their concerns through systematic technical submissions, the company maintains a commitment to compliance and quality assurance.

Production, Quality Control, and Operational Resilience

ImmuCell's manufacturing processes are designed to deliver products that meet high standards of quality. The company has implemented robust remediation steps to control bioburden and streamline production yields following prior contamination challenges. This operational resilience is critical to sustaining output levels and delivering consistent product performance. The strategic focus on process improvement, yield optimization, and regulatory compliance allows the company to meet market demand while safeguarding animal health outcomes.

Market Position and Competitive Landscape

Within the animal health industry, ImmuCell occupies a unique position by combining pioneering biotechnology with practical, field-tested applications. The company differentiates itself through its dual focus on immediate prevention of health issues in newborn calves and the innovative treatment of subclinical mastitis in dairy cows. These solutions not only address immediate veterinary health challenges but also offer economic benefits to producers. The strategic integration of research, regulated manufacturing, and targeted market segments underscores ImmuCell's expertise and commitment to advancing veterinary medicine.

Scientific Approach and Industry Expertise

ImmuCell’s products are the result of rigorous research and development, backed by peer-reviewed scientific studies and extensive field trials. This scientific rigor ensures that every product is both effective and reliable. By focusing on tangible improvements in animal health and productivity, the company provides real-world solutions that reflect deep industry knowledge and an unwavering commitment to innovation.

Operational Strategy and Value Proposition

The core value proposition of ImmuCell lies in its ability to translate scientific research into practical applications that deliver measurable benefits. The dual-segment strategy not only diversifies revenue streams but also optimizes the company’s response to the specific needs of dairy and beef operations. With a commitment to quality, regulatory compliance, and process optimization, ImmuCell continues to address longstanding challenges within the livestock industry, making it a significant entity in the animal health sector.

Conclusion

Overall, ImmuCell Corporation stands as a dedicated biotechnology company at the forefront of animal health innovation. Its comprehensive approach—encompassing research-driven product development, strict regulatory adherence, and an unwavering focus on operational excellence—positions it as a key participant in improving the productivity and health of dairy and beef cattle. The company’s continued efforts in refining production processes and enhancing product efficacy underline its commitment to delivering scientifically substantiated, economically impactful solutions for the livestock industry.

Rhea-AI Summary

ImmuCell (ICCC) reported record-breaking preliminary sales results for Q1 2025, achieving $8.1 million in quarterly sales, an 11% increase from Q1 2024. The company's performance showed strong growth with six-month sales reaching $15.8 million (up 28%) and twelve-month sales hitting $27.3 million (up 28%) through March 31, 2025.

The Q1 2025 results exceeded the previous record set in Q4 2024 by 4%, helping reduce the order backlog to $4.0 million from $4.4 million. Production output during Q1 2025 reached approximately 108% of the company's estimated $30 million annual capacity.

Additionally, ImmuCell is initiating Investigational Product use of Re-Tain® through a controlled launch to test market acceptance. The company submitted its Non-Administrative New Animal Drug Application in January 2025, though approval remains pending facility inspections at their contract manufacturer.

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ImmuCell (Nasdaq: ICCC) has appointed Timothy C. Fiori as its new Chief Financial Officer. Fiori brings approximately 24 years of finance and commercial operating experience from IDEXX Laboratories in Westbrook, Maine. He holds a B.S. in Finance from the University of Maine (2001).

The company, which develops and manufactures products for dairy and beef cattle health, sees this hire as a strategic move in its growth plan. CEO Michael F. Brigham highlighted that Fiori will help leverage personnel, improve standard costing and financial reporting systems, and enhance business efficiencies.

ImmuCell's key products include First Defense®, providing Immediate Immunity™ to newborn dairy and beef calves, and is developing Re-Tain®, a novel treatment for subclinical mastitis in dairy cows without FDA-required milk discard or pre-slaughter withdrawal restrictions.

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ImmuCell (Nasdaq: ICCC) has announced the initiation of Investigational Product use of Re-Tain®, its novel treatment for subclinical mastitis in dairy cows. This controlled launch will help test market acceptance and utilize available inventory before shelf-life expiration, though it's not expected to generate significant revenue or profit.

The company submitted its Non-Administrative New Animal Drug Application (NADA) in early January 2025, including its fourth CMC Technical Section submission along with minor technical sections for All Other Information and Product Labeling. The critical path to NADA approval remains contingent on clearing inspectional observations at the facilities of ImmuCell's contract manufacturer.

This investigational strategy allows ImmuCell to gather product performance data while awaiting full NADA approval. Re-Tain® aims to provide an alternative to traditional antibiotics without FDA-required milk discard or pre-slaughter withdrawal label restrictions.

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ImmuCell (ICCC) reported strong financial results for Q4 and full-year 2024, with product sales increasing 52% to $7.8 million in Q4 and $26.5 million for the full year. The company demonstrated significant operational improvements with gross margin expanding to 37% in Q4 2024 from 25% in Q4 2023.

The company achieved positive EBITDA of $1.3 million in Q4 2024, compared to negative ($311,000) in Q4 2023. Net income for Q4 2024 was $515,000 ($0.06 per share), versus a loss of ($1.14 million) in Q4 2023. Cash position strengthened to $3.8 million, up from $979,000 year-over-year.

ImmuCell has operated without contamination issues since April 2024, focusing on improving production yields and gross margins. The company continues to work towards FDA approval for Re-Tain®, with a recent submission of the Non-Administrative NADA in January 2025.

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ImmuCell (Nasdaq: ICCC) has announced it will release its unaudited financial results for Q4 and full-year 2024 after market close on February 25, 2025. The company will host a conference call on February 26, 2025, at 9:00 AM ET to discuss these results.

The company confirms there are no changes to the preliminary sales results disclosed on January 9, 2025, and expects to file its Annual Report on Form 10-K by March 31, 2025. An updated Corporate Presentation will be available on the company's website after market close on February 25, 2025.

ImmuCell, which focuses on developing products for dairy and beef cattle health, manufactures First Defense® for newborn calf immunity and is developing Re-Tain® for treating subclinical mastitis in dairy cows without FDA-required milk discard or meat withhold restrictions.

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ImmuCell (Nasdaq: ICCC) has announced the settlement of an insurance claim related to production contamination events that occurred from late 2022 through April 2024. The company has accepted a settlement of $426,587, which is in addition to the $250,000 previously paid and recognized during the third quarter of 2023.

The company will host a conference call on February 26, 2025, at 9:00 AM ET to discuss unaudited financial results for Q4 and full-year 2024. ImmuCell manufactures First Defense® for newborn dairy and beef calves and is developing Re-Tain®, a treatment for subclinical mastitis in dairy cows without FDA-required milk discard or meat withhold restrictions.

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ImmuCell (ICCC) reported strong preliminary, unaudited sales results for Q4 and full year 2024. The company achieved total sales of $7.8 million in Q4 2024, a 52% increase from $5.1 million in Q4 2023. Full-year 2024 sales reached $26.5 million, up 52% from $17.5 million in 2023.

Production output during Q4 2024 reached 103% of the company's estimated full capacity of $30 million per year. This helped reduce the order backlog to $4.4 million as of January 1, 2025, down from $9.4 million a year earlier. The company attributes the current backlog to strong demand as distributors replenish buffer stocks and end-users place orders ahead of peak calving season.

ImmuCell also reported progress on Re-Tain®, with the recent submission of its Non-Administrative NADA to the FDA, including the fourth CMC Technical Section submission and discussions about expedited review.

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ImmuCell (ICCC) reported significant growth in Q3 2024, with product sales increasing 11% to $6 million compared to Q3 2023. The company achieved a 51% increase in nine-month sales to $18.7 million and a 46% rise in trailing twelve-month sales to $23.8 million. Gross margin improved to 26% in Q3 2024 from 23% in Q3 2023. The net loss narrowed to $702,000 ($0.09 per share) compared to $940,000 ($0.12 per share) in Q3 2023. Cash position strengthened to $3.8 million, though this came at the cost of some stockholder dilution through an at-market offering.

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ImmuCell (Nasdaq: ICCC) announced it will report unaudited financial results for Q3 2024 after market close on November 13, 2024. The company will host a conference call on November 14, 2024 at 9:00 AM ET to discuss the results. The company anticipates no changes to the preliminary sales results disclosed on October 8, 2024. ImmuCell develops and manufactures products improving health and productivity of dairy and beef cattle, including First Defense® for newborn calf immunity and Re-Tain® for subclinical mastitis treatment.

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ImmuCell (Nasdaq: ICCC) announced preliminary, unaudited sales results for Q3 2024. Key highlights include:

- Total sales for Q3 2024 were $6.0 million, an 11% increase from Q3 2023
- Nine-month sales reached $18.7 million, up 51% year-over-year
- Twelve-month sales totaled $23.8 million, a 46% increase from the previous year
- Annualized production output was approximately 73-81% of the estimated full capacity of $30 million per year
- Backlog of orders as of September 30, 2024, was approximately $7.3 million

The company continues to work towards FDA approval for Re-Tain®, with plans to submit a Non-Administrative NADA later in 2024. ImmuCell will host a conference call on November 14, 2024, to discuss Q3 2024 financial results.

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FAQ

What is the current stock price of Immucell (ICCC)?

The current stock price of Immucell (ICCC) is $5.46 as of April 22, 2025.

What is the market cap of Immucell (ICCC)?

The market cap of Immucell (ICCC) is approximately 48.7M.

What is ImmuCell Corporation's core business?

ImmuCell Corporation specializes in developing and manufacturing scientifically proven animal health products that improve the productivity and health of dairy and beef cattle.

How does ImmuCell generate revenue?

The company generates revenue primarily through its Scours segment, which focuses on products that prevent scours in newborn calves, while also investing in its Mastitis segment for treating subclinical mastitis in dairy cows.

What are the company’s main product segments?

ImmuCell operates two key segments: one for preventing scours in calves and another for treating subclinical mastitis in lactating dairy cows, offering innovative solutions in animal health.

Which regulatory agencies oversee ImmuCell's products?

The company’s products fall under regulatory oversight by the United States Department of Agriculture (USDA) and the United States Food and Drug Administration (FDA), ensuring the products meet established safety and efficacy standards.

How does ImmuCell differentiate itself in the animal health market?

By combining rigorous scientific research with practical product applications, ImmuCell addresses specific challenges in calf and dairy cow health, offering unique solutions that are validated through regulatory compliance.

What is the significance of the Scours segment for ImmuCell?

The Scours segment is critical as it delivers immediate immunity products for newborn calves, thereby reducing early-life health challenges and enhancing overall productivity in dairy and beef operations.

What is the focus of the Mastitis segment?

The Mastitis segment targets subclinical mastitis in lactating dairy cows, providing a treatment alternative with no need for milk discard, differing from traditional antibiotic therapies.

How does ImmuCell address production and quality challenges?

The company continuously optimizes its production processes through strict quality control and remediation steps, ensuring its products consistently meet regulatory standards and perform effectively in the field.
Immucell

Nasdaq:ICCC

ICCC Rankings

ICCC Stock Data

48.69M
5.89M
34.74%
13.56%
0.19%
Biotechnology
In Vitro & in Vivo Diagnostic Substances
Link
United States
PORTLAND