Core Insights - ImmuCell estimates the worldwide total addressable market for scour protection at approximately $900 million [1] - The company is shifting its strategy to focus on the First Defense calf-health franchise while pausing investment in Re-Tain due to an FDA "Incomplete Letter" [6][5] Market Dynamics - Management highlighted that the economics of newborn calves have changed significantly, with calf values rising from about $200 in 2003 to approximately $1,300 today, leading to increased demand for scour protection [2] - Calf sales have grown from 2%-3% to 20%-25% of annual dairy income for some operations [2] Strategic Shift - ImmuCell plans to complete ongoing investigational studies for Re-Tain by 2026 and will focus on expanding First Defense capacity instead [3] - The decision to pause investment in Re-Tain is based on confidence in First Defense's growth potential and the implications of the FDA's Incomplete Letter [5] Financial Performance - Unaudited product sales for Q4 2025 were reported at $7.6 million, a decrease of 1.6% from Q4 2024, with domestic sales growing 8.7% year-over-year [8][9] - Total product sales for the full year 2025 increased by 4.3% to $27.6 million, with a noted shift towards the Tri-Shield product within the First Defense suite [10] Manufacturing and Compliance Issues - ImmuCell has passed FDA requirements for safety and efficacy for Re-Tain, but issues with the contract manufacturer responsible for aseptic filling have delayed approval [12][13] - The company plans to repurpose most manufacturing assets from Re-Tain for First Defense, although certain equipment will not be useful [16] Future Plans and Investments - The company is expanding its sales team by 50% and creating two new U.S. territories to enhance commercial expansion [19] - Management anticipates a non-cash impairment write-down of approximately $2.9 million related to Re-Tain, along with an estimated inventory write-down of about $600,000 [17][18] - Additional capital may be needed for future investments, including a potential $3 million capital outlay for a new freeze dryer [20]