ImmuCell Q4 Earnings Call Highlights

ImmuCell (NASDAQ:ICCC) utilized a January 9 league telephone to outline a strategical displacement toward its First Defense calf-health franchise portion reporting unaudited fourth-quarter and full-year 2025 income results. Management said the institution volition intermission concern successful Re-Tain, its long-developed mastitis attraction candidate, pursuing an FDA “Incomplete Letter” that absorption attributed solely to issues astatine the declaration shaper liable for aseptic filling.

President and CEO Oliver Taboukos said the institution is “shifting our strategy arsenic a institution to absorption connected First Defense” and suspending concern successful manufacturing Re-Tain. Taboukos framed the determination astir 2 factors: assurance successful First Defense’s maturation imaginable and the applicable effect of the FDA’s Incomplete Letter for Re-Tain’s caller carnal cause application.

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According to Taboukos, the Incomplete Letter means ImmuCell is “still years away, alternatively than conscionable months away,” from an FDA-compliant manufacturing solution indispensable for launch. He said that continuing to put successful Re-Tain would person required accrued expenses and superior investment, which absorption believes would divert resources from First Defense.

Instead, ImmuCell plans to implicit investigational studies already underway successful 2026 and past “prepare the champion lawsuit we tin for a imaginable aboriginal spouse for Re-Tain,” Taboukos said. He added that the institution volition redeploy astir manufacturing assets built for Re-Tain toward expanding First Defense capacity, noting that some operations usage liquid processing equipment.

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Management pointed to changes successful the economics of newborn calves arsenic a cardinal operator for accrued request for scour protection. Taboukos said calf values person risen substantially implicit the past 5 years, citing factors including beef-on-dairy cross-breeding, drought, and the closing of the Mexican border. He said newborn calves tin beryllium worthy astir $1,300 connected time 1 of beingness compared with astir $200 successful 2003, and that calf income person grown from 2%–3% to 20%–25% of yearly dairy income for immoderate operations.

ImmuCell estimates the worldwide full addressable marketplace for scour extortion astatine astir $900 million. The company’s stated strategy is to summation lawsuit engagement utilizing “strong medical, scientific, and outcomes-based arguments” to thrust adoption.