ImmuCell Announces Strategic Focus on First Defense® After Receiving an FDA Incomplete Letter for Re-Tain®

Core Viewpoint - ImmuCell Corporation has received an Incomplete Letter from the FDA regarding its Re-Tain New Animal Drug Application, prompting the company to shift focus towards expanding its First Defense product line, which is expected to drive significant revenue growth [1][2][5]. Group 1: FDA Approval and Manufacturing - ImmuCell received Complete Letters for four out of five Technical Sections required for NADA approval but faced issues with the contract manufacturer related to inspectional deficiencies [2]. - The company had adopted a dual manufacturing strategy to mitigate capital expenditure and technical risks, involving both in-house production and a contract manufacturer [2]. - ImmuCell's facility passed FDA inspection in 2024, but the contract manufacturer's deficiencies led to the current Incomplete Letter [2]. Group 2: Strategic Shift and Investment - Due to delays and the impending expiration of the contract with the manufacturer in March 2026, ImmuCell has decided to pause further investment in Re-Tain and instead increase investment in its First Defense franchise [3][4]. - The First Defense product line is expected to benefit from significant revenue and profit growth, with a focus on the $900 million global market for preventing scours in calves [5]. - ImmuCell plans to repurpose facilities and equipment from the Re-Tain project to enhance First Defense capacity, anticipating a non-cash impairment write-down of approximately $2.3 million [6][7]. Group 3: Market Position and Growth Potential - First Defense has shown strong market performance, with annual revenue growth from approximately $4.4 million to $27.8 million over the past fifteen years, reflecting a compounded growth rate of over 13% per year [7]. - The product line holds a 29% share of the U.S. market for scours prevention and is positioned for international expansion and new product development [5][7]. - Customer feedback and market assessments indicate a favorable environment for further investment in First Defense, which leverages proprietary colostrum hyper-immunization technology [5][7].