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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.
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.
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.
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.
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.
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.
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.
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.
ImmuCell (Nasdaq: ICCC) announced unaudited financial results for Q2 2024. Highlights include:
- Product sales increased 55% to $5.5 million in Q2 2024 vs Q2 2023
- Product sales up 82% to $12.7 million for H1 2024 vs H1 2023
- Trailing twelve-month product sales grew 48% to $23.2 million
Despite sales growth, the company reported a net loss of $1.5 million in Q2 2024. Gross margin declined to 22% in Q2 2024 from 30% in Q2 2023. The company aims to produce finished goods worth $12 million+ every six months, targeting 80%+ of its estimated $30 million annual production capacity.
ImmuCell is working to resolve production contamination issues and improve yields. The FDA issued an Incomplete Letter for the Re-Tain® product, requiring resolution of inspectional observations at the contract manufacturer before resubmission.
ImmuCell (Nasdaq: ICCC) will announce its unaudited financial results for the quarter ended June 30, 2024, after market close on Tuesday, August 13, 2024. A conference call is scheduled for Wednesday, August 14, 2024, at 9:00 AM ET to review these results. Access the call at (844) 855-9502 (toll-free) or (412) 317-5499 (international). A replay is available until August 21, 2024, at (877) 344-7529 (toll-free) or (412) 317-0088 (international), using access code #3744296.
The Company expects no changes to the preliminary sales results disclosed on July 9, 2024. The Quarterly Report on Form 10-Q will be filed after market close on August 13, 2024. Investors are encouraged to review the updated Corporate Presentation slide deck on the Company's website post-announcement.
ImmuCell (Nasdaq: ICCC) has announced preliminary, unaudited sales results for Q2 2024. The company reported a 55% increase in sales to $5.47 million for the three-month period ended June 30, 2024, compared to $3.53 million in the same period of 2023. For the first half of 2024, sales rose by 82% to $12.73 million, and for the twelve-month period, sales increased by 48% to $23.22 million. The company's production output was between 74% and 85% of its full capacity. Additionally, ImmuCell is working towards FDA approval for Re-Tain®, with submission expected after resolving inspectional observations. A conference call is scheduled for August 14, 2024, to discuss these results further.
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