ImmuCell(ICCC -7.74%) reported results for the three-month period ended June 30, 2025, on August 14, 2025, highlighting a sharp rebound in profitability with adjusted EBITDA of $1.43 million. Strategic updates included the completion of First Defense production capacity expansion and ongoing delays in FDA approval for Retain, along with an improved debt structure.

ImmuCell completes First Defense capacity expansion

In this period, ImmuCell finalized its multi-year investment to expand production capacity, targeting the ability to support annual revenue of $30 million or more, removing prior supply bottlenecks. Backlog liquidation, inventory distribution rebuild, and a return to normal distribution channels followed supply disruptions caused by contamination events, which were resolved by Q2 2025.

"Our investment to increase production capacity for the First Defense product line to support $30 million or more in revenue per year is now complete. For sure, this took longer than we had planned as the process was plagued by certain contamination events and other challenges. That said, it is done, and we are in a good place going forward."
-- Michael Brigham, President and CEO

This operational milestone shifts management focus from crisis recovery to growth, reducing a major operational risk that had impaired customer relationships and positioning the company to recapture lost business and drive future market share gains.

ImmuCell gross margin more than doubles YoY

Gross margin as a percentage of product sales increased to 44% in 2025 compared to 22% in 2024, with trailing twelve-month gross margin rising from 26% to 37% YoY. Improved production output in 2025 enabled fulfillment of backorders and channel inventory replenishment, although management warned these factors temporarily inflated near-term revenue and may not recur in the back half of 2025.

"Gross margin as a percentage of product sales increased to 44% during the 2025 compared to just 22% during the 2024, with the trailing twelve-month gross margin rising to 37% for the period ended 06/30/2025 compared to just 26% for the period ended 06/30/2024."
-- Tim Fiori, CFO

These margin improvements reflect both operational recovery and temporary benefits from inventory restocking, suggesting investors should monitor for normalization in the second half of the year.

FDA delay stalls Retain commercial launch, triggers strategic review

Management completed the facility inspection for its own drug substance manufacturing with no Form 483 citations from FDA, but the contract manufacturing organization (CMO) responsible for aseptic fill-finish faces ongoing FDA inspection observations, which remain unresolved and outside ImmuCell’s control. Retain inventory produced for commercial launch will instead be used in investigational product use studies, generating no sales, while the company seeks financial and marketing support for eventual commercialization.

"The frustrating challenge is that we use a CMO for aseptically filling our drug substance into the tubes. That CMO has to resolve 43 inspection observations. And I wish as much and probably more than you that I could put a timeline on that. It's extremely frustrating. It's been going on for over a year now. I do know with confidence they're working hard on it. But I don't know the timing on either end—their success or the FDA's agreement to their success. It's an open inspection that they are motivated to resolve not just for Retain, but for other products in their suite. It is the final hurdle to FDA approval and we're eager to get it resolved, but it is almost totally out of our control, and the FDA and the CF are working on it."
-- Michael Brigham, President and CEO

This externally driven delay in Retain’s approval and commercial launch introduces uncertainty into the near- and mid-term growth trajectory, heightening the importance of prudent cash management and increasing the strategic value of partnering with organizations possessing financial and marketing resources.

Looking Ahead

Management will not pursue a full commercial launch of Retain until FDA approval is obtained, a validated aseptic fill solution is in place, and adequate cash is available to produce commercial inventory. The company anticipates completing investigational product use studies and related data analysis during 2026, which will inform ongoing strategic partnership discussions for Retain. Expansion to $40 million-plus First Defense production capacity remains on hold, pending stronger cash flows and greater market clarity in the second half of 2025.