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ImmuCell Corporation (ICCC) is a biotechnology leader focused on developing innovative health solutions for dairy and beef cattle. This page provides investors, industry professionals, and stakeholders with timely updates on the company’s scientific advancements, regulatory milestones, and market developments.
Access the latest press releases, earnings reports, and strategic announcements in one centralized location. Our curated collection includes updates on product innovations, FDA/USDA regulatory progress, financial performance, and partnerships that shape the animal health sector.
Key coverage areas include new product launches, financial results, manufacturing updates, and scientific research breakthroughs. Stay informed about developments in ImmuCell’s core segments: preventive care for newborn calves and mastitis treatment solutions for dairy cows.
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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.
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.
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