ICCC News & Events

Reports preliminary FY25 revenue $27.6M. "Sales for the quarter exceeded our expectations and show that we continue to make progress rebuilding our market position after a period of supply challenges," commented Olivier te Boekhorst, president and CEO of ImmuCell. "This was one of our highest sales quarters ever, without tailwinds from catching up on backorders. Our international business showed a decline, largely due to order timing. We are highly encouraged by the strong growth of our Tri-Shield product line, which reflects the migration from Dual-Force products and the acquisition of new dairy and beef customers seeking protection for their calves."

ImmuCell Corporation announced that it received an Incomplete Letter from the FDA on December 23 for its Re-Tain New Animal Drug Application, or NADA, and simultaneously that it is increasing its First Defense field sales force by 50% and expanding its First Defense manufacturing capabilities. In seeking FDA approval to bring its innovative Re-Tain product to market, ImmuCell received Complete Letters from the FDA for four of the five Technical Sections required for NADA approval. It pursued a two-pronged manufacturing approach to reduce capital expenditure and limit technical risk for the remaining fifth Technical Section pertaining to manufacturing. ImmuCell manufactured the active pharmaceutical ingredient using a proprietary process in its own facility and hired an experienced contract manufacturer with FDA approvals for animal health products for the aseptic filling of the product into syringes. ImmuCell passed FDA inspection of its own facility in 2024. It is ImmuCell's understanding that the FDA is now declining to approve the NADA because the contract manufacturer has not satisfactorily addressed inspectional deficiencies. After considering the practical implications of the resulting delays, including the pending expiration of ImmuCell's contract with the manufacturer in March 2026, ImmuCell has decided to pause further investment in Re-Tain and increase its investment in its market leading First Defense franchise, which it believes to have significant revenue and profit growth capacity. ImmuCell will complete ongoing investigational studies with Re-Tain to assess opportunities for an improved set of claims for preventing and treating mastitis in dairy cows. It will seek to license the product to interested parties or, depending on the outcome of the studies, may seek to partner with a global manufacturer. Neither approach would require further capital investment or in-house manufacturing capability, meaning that ImmuCell will prioritize cash and other resources for maximizing the value of its market leading First Defense franchise.

"Backlog depletion and buffer stock replenishment appear to have resulted in a one-time lift in sales volume during the first half of 2025," commented Timothy Fiori, CFO of ImmuCell. "Our sales team is aggressively working to rebuild lost market share now that we have the inventory levels needed to support continued growth going forward, and we remain focused on and confident about developing sustainable, long-term growth of the First Defense(R) product line."

ImmuCell Corporation announced that it has selected Olivier te Boekhorst as its next president and CEO. The company anticipates a start date of November 1 for te Boekhorst. te Boekhorst is currently an operating partner at ARCHIMED, and serves as chair of the board of SeqCenter, a Next Generation Sequencing laboratory where he previously served as CEO.