v3.25.2
Business Operations
6 Months Ended
Jun. 30, 2025
Business Operations [Abstract]  
BUSINESS OPERATIONS

1. BUSINESS OPERATIONS

 

ImmuCell Corporation (the “Company”, “we”, “us”, “our”) was originally incorporated in Maine in 1982 and reincorporated in Delaware in 1987, in conjunction with an initial public offering of common stock. We are an animal health company whose purpose is to create scientifically proven and practical products that improve the health and productivity of dairy and beef cattle. We focus on the two most critical stages of dairy productivity, those being the first 30 days of life and the first 30 days of lactation. Our concentrated colostrum and purified Nisin technologies could offer unique animal health solutions during these periods when immunity is at its most vulnerable. As disclosed in Note 16, “Segment Information”, one of our business segments is dedicated to Scours and the other is focused on Mastitis. We manufacture and market the First Defense® product line, providing Immediate Immunity™ to prevent scours in newborn dairy and beef calves. Our product line offers three formats in two distinct platforms: veterinary biologics providing protection against E. coli, coronavirus, and rotavirus, and functional feed products delivering concentrated bioactive colostrum proteins. We are developing Re-Tain® – a treatment for subclinical mastitis in lactating dairy cows. Upon approval, it could represent a first-of-its-kind new animal drug, unrelated to human-use antibiotics. The governing regulatory authorities are Center for Veterinary Biologics, U.S. Department of Agriculture and American Association of Feed Control Officials for First Defense®, and Center for Veterinary Medicine, U.S. Food and Drug Administration for Re-Tain®. We are subject to certain risks including dependence on key individuals and third-party providers of critical goods and services, competition from other larger companies, the successful sale of existing products and the development of new viable products with appropriate regulatory approvals, where applicable. A combination of the conditions, trends and concerns related to or arising from tariffs, inflation, rising interest rates and potential recessionary conditions in the United States and/or internationally, could have a corresponding negative effect on our business and operations. We are experiencing price increases in key components, supportive services, transportation and other supplies that are causing our costs of goods sold to increase. We experienced contamination events in our production process, beginning in the third quarter of 2022 and through April of 2024, as disclosed previously. We implemented a production slowdown during 2023 to remediate this problem, which led to the recognition of lower sales and gross margin. We have experienced just one further contamination event since April of 2024, which occurred during the second quarter of 2025.