IMMUCELL CORP /DE/
For the period ended Jun 30, 2026. Filed Aug 13, 2026.
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Jun 30, 2026 · Filed Aug 13, 2026
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ITEM 1A. Risk Factors
Except as set forth below, there have been no material changes from the risk factors identified in our Annual Report on Form 10-K for the year ended December 31, 2025, in response to Item 1A., “Risk Factors,” of Part I of the Annual Report.
Production capacity constraints: The inability to meet market demand for our products is a risk to our business. Our plans call for increases of our production capacity through yield improvements, redeploying assets previously slated for production of Re-Tain® and investing approximately $3.5 million in incremental freeze drying capacity and approximately $4.5 million in colostrum processing capacity over the next 12 to 18 months. Expanding manufacturing capacity involves practical and technical risks affecting efficiency of production including contamination and yields, and risks of not being able to access sufficient high-quality colostrum or other raw materials. There is a risk of cost overruns in our production expansion project, and a risk that we will not be able to achieve our production capacity growth objectives on a timely basis, resulting in a shortfall in supply to the market. A backlog of orders presents a risk that we could lose customers that are not easily regained. Our long-term capital plan to continue to expand the First Defense®** **product line requires ongoing review of equipment capacity and utilization and assessment of costs, functional obsolescence and reliability of equipment. This review and assessment could identify a need to fund unexpected equipment maintenance or replacement costs.
Colostrum collection: There is a risk that the farms that participate in our vaccination and colostrum collection process no longer wish to continue supplying us with colostrum, due to the need to use all or part of the colostrum for their own calves, or concerns with the increasing cost of colostrum-replacement products, or higher prices offered by other companies that use colostrum to develop human or animal health products. There is a risk that our supply farms, which are almost entirely located in one state, are subject to a disease outbreak that inhibits their ability to supply the colostrum. There is a risk that the quality of the colostrum collected will not be suitable for our production requirements.
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