ImmuCell (NASDAQ:ICCC) used a January 9 conference call to outline a strategic shift toward its First Defense calf-health franchise while reporting unaudited fourth-quarter and full-year 2025 sales results. Management said the company will pause investment in Re-Tain, its long-developed mastitis treatment candidate, following an FDA “Incomplete Letter” that management attributed solely to issues at the contract manufacturer responsible for aseptic filling.
Strategic pivot: focus on First Defense, pause Re-Tain investment
President and CEO Oliver Taboukos said the company is “shifting our strategy as a company to focus on First Defense” and suspending investment in manufacturing Re-Tain. Taboukos framed the decision around two factors: confidence in First Defense’s growth potential and the practical effect of the FDA’s Incomplete Letter for Re-Tain’s new animal drug application.
Instead, ImmuCell plans to complete investigational studies already underway in 2026 and then “prepare the best case we can for a potential future partner for Re-Tain,” Taboukos said. He added that the company will redeploy most manufacturing assets built for Re-Tain toward expanding First Defense capacity, noting that both operations use liquid processing equipment.
First Defense market opportunity and production improvements
Management pointed to changes in the economics of newborn calves as a key driver for increased demand for scour protection. Taboukos said calf values have risen substantially over the past five years, citing factors including beef-on-dairy cross-breeding, drought, and the closing of the Mexican border. He said newborn calves can be worth about $1,300 on day one of life compared with roughly $200 in 2003, and that calf sales have grown from 2%–3% to 20%–25% of annual dairy income for some operations.
ImmuCell estimates the worldwide total addressable market for scour protection at approximately $900 million. The company’s stated strategy is to increase customer engagement using “strong medical, scientific, and outcomes-based arguments” to drive adoption.
On operations, Taboukos highlighted manufacturing progress and said output in the company’s key bottleneck process—lyophilization—rose more than 15% in 2025. He said management believes a similar increase is achievable in 2026 “without using significant incremental capital.” Taboukos also said repurposing former Re-Tain assets will help prevent liquids processing throughput from becoming a constraint as First Defense demand grows.
Unaudited sales: near-record quarter, U.S. growth offset by international timing
CFO Tim Fiori reported unaudited product sales of $7.6 million for the fourth quarter, down 1.6% from the fourth quarter of 2024. He said the comparison was challenging because the prior-year quarter benefited from orders tied to catching up from a backorder situation, which also boosted the first half of 2025.
Domestic sales grew 8.7% year-over-year in the fourth quarter to $7.0 million, while international sales declined, which Fiori said was “mainly driven by order timing in Canada,” where fourth-quarter sales fell 52.6% year-over-year.
For the full year 2025, Fiori said total product sales increased 4.3% versus 2024 to $27.6 million. He also noted a shift within the First Defense product suite toward Tri-Shield in both the quarter and full year, reflecting what he described as migration from Dual-Force products and new dairy and beef customer adoption.
Re-Tain FDA setback and manufacturing responsibility
Taboukos said ImmuCell had passed FDA requirements for safety, efficacy, and four of five technical sections of the Re-Tain application, with the remaining section tied to manufacturing. The company had outsourced the aseptic filling step—putting the active ingredient into syringes—to a contract manufacturer to limit capital spending and risk, he said.
Management declined to discuss detailed conversations with the contract manufacturer, but Taboukos said the company understands the FDA declined approval because the contract manufacturer “had still not satisfactorily addressed previously cited inspectional deficiencies.” He also said the contract manufacturer has refused to extend its contract beyond March 2026, which would have required ImmuCell to restart the manufacturing section and spend an unknown period of time to obtain approval.
In response to a question about the product’s manufacturing structure, Taboukos drew a distinction between ImmuCell’s production of the active pharmaceutical ingredient (drug substance) and the outsourced aseptic filling of the drug product. He said FDA inspections of ImmuCell’s internal processes have been passed, and that the blockage relates only to the outsourced portion.
Taboukos said Michigan State University is conducting a study designed to support an expanded set of claims, with enrollment essentially completed in December. He said the university expects to complete the studies in the first half of 2026, and that ImmuCell will not rush the work because rigor will be important for partnering discussions.
Balance sheet impacts, hiring plans, and capital considerations
Fiori said the company evaluated more than $15 million in Re-Tain-related property, plant, and equipment and concluded most of it—including the building and much of the equipment—should be useful for First Defense liquids processing. However, he said certain items such as aseptic filling machinery will not be useful for First Defense.
As an immediate result, Fiori said the company expects a non-cash impairment write-down estimated at $2.9 million that will impact the fourth quarter of 2025. He added that modifications to the building and additional capital will be necessary as the repurposing plan is evaluated.
Separately, Fiori said management expects an estimated inventory write-down of about $600,000, mainly related to previously purchased colostrum deemed not suitable for the company’s requirements and intended to be sold on the open market without further processing.
On commercial expansion, Taboukos said ImmuCell is expanding its sales team by 50%, creating two new U.S. territories and adding an international business development executive. He said hiring processes are underway and that the company hopes to complete them during the quarter.
Asked about funding future investments, Fiori said additional capital may be needed, including for a potential “freeze dryer number five,” which he described as an approximately $3 million capital outlay, and for repurposing the former Re-Tain facility. He declined to specify how investments would be funded, noting that operating cash flow, loans, and capital raises are among the possible options depending on economics at the time.
The company said it will hold its full-year financial results call in late February, with management pointing to February 26, 2026 as the date for reviewing results for the year ended December 31, 2025.
In closing remarks, Taboukos thanked outgoing CEO Michael Brigham for 30 years of service, including 25 years as CEO, noting that January 9 was Brigham’s last day with the company.
About ImmuCell (NASDAQ:ICCC)
ImmuCell Corporation (NASDAQ: ICCC) is a biotechnology company that develops, manufactures, and markets immunological products and diagnostic assays designed to enhance animal health in dairy and beef cattle. Headquartered in Portland, Maine, the company focuses on supporting herd health management through its portfolio of passive immunology solutions and veterinary diagnostics.
The company’s flagship offering, CalfGuard natural colostrum supplement, is formulated to promote the passive transfer of antibodies in newborn calves and reduce the incidence of neonatal diseases.
