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

Rhea-AI Summary

ImmuCell (Nasdaq: ICCC) received an FDA Incomplete Letter for its Re-Tain NADA on December 23, 2025 after four of five technical sections were deemed complete and the contract manufacturer failed to satisfactorily address inspectional deficiencies. ImmuCell will pause further investment in Re-Tain, complete ongoing investigational studies, and pursue licensing or partnering options that avoid further capital or in-house manufacturing expenditure.

ImmuCell is simultaneously increasing First Defense field sales by 50%, expanding First Defense manufacturing, and expects a ~$2.3 million estimated non-cash impairment in Q4 2025 (Re-Tain net book value was $15.5M as of Sept 30, 2025). First Defense reported $27.8M TTM revenue and holds a 29% U.S. spend share in scour prevention; company estimates a $900M worldwide TAM for scours prevention.

Positive

• Increased First Defense field sales force by 50%
• First Defense trailing twelve-month revenue of $27.8M (ended Sep 30, 2025)
• First Defense holds 29% U.S. spend share and #1 ranking for scour-prevention

Negative

• Received FDA Incomplete Letter for Re-Tain NADA due to contract manufacturer deficiencies
• Anticipated non-cash impairment of approximately $2.3M in Q4 2025 (Re-Tain net book value ~$15.5M)
• Contract manufacturing issues create timing risk with contract expiring March 2026

Key Figures

TAM – scours prevention $900 million Estimated worldwide Total Addressable Market for preventing scours in calves

First Defense® U.S. share 29% Share of U.S. spend on scours prevention

First Defense® CAGR more than 13% per year Compounded annual growth over more than a decade

First Defense® revenue then $4.4 million Annual revenue about fifteen years ago

First Defense® TTM revenue $27.8 million Trailing twelve‑month period ended September 30, 2025

Re‑Tain® net book value $15.5 million Net book value of Re‑Tain® assets as of September 30, 2025

Impairment impact $2.3 million Estimated non‑cash impact to profit from impairment in Q4 2025

Sales force expansion 50% increase Planned expansion of First Defense® field sales force

Market Reality Check

$5.92 Last Close

Volume Volume 45,363 vs 20-day average 16,503 (about 2.75x typical activity) ahead of this news. high

Technical Trading slightly below its 200-day MA at $5.93, with price at $5.82 pre-release.

Peers on Argus 1 Up

ICCC was down 1.36% while peers were mixed: MAIA up 0.74% (and flagged in momentum at +8.54%), JUNS down 5.31%, PYPD down 2.01%, KPTI up 2.34%. This points to stock-specific factors.

Common Catalyst Only one peer (MAIA) had same-day news, tied to private placement financings, suggesting no shared catalyst with ICCC.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 13	Earnings report	Positive	-1.3%	Improved margins and swing to net income, but shares fell modestly.
Nov 06	Earnings timing	Neutral	-3.3%	Announcement of Q3 earnings date and call with no sales changes.
Nov 04	Management change	Positive	+5.0%	Onboarding of new CEO and CFO board role supported by market.
Oct 07	Sales update	Positive	+1.6%	Preliminary Q3 sales with trailing twelve‑month growth and Re‑Tain note.
Sep 29	CEO selection	Positive	+2.5%	Selection of next CEO with strong sector experience boosted sentiment.

Pattern Detected

Stock reactions to recent news have mostly aligned with event tone, with one divergence on stronger-than-usual earnings metrics.

Recent Company History

Over the last few months, ImmuCell has focused on financial recovery and leadership transition. Q3 2025 results showed improving margins and a return to $1.8M nine‑month net income after prior losses, but shares slipped after both the earnings date notice and the report. Governance updates around the new CEO, Olivier te Boekhorst, drew modestly positive reactions. Today’s FDA Incomplete Letter for Re‑Tain® and pivot toward the First Defense® franchise contrasts with earlier optimism about investigational Re‑Tain use and ongoing sales growth.

Market Pulse Summary

This announcement outlines a major strategic shift: pausing further internal investment in Re‑Tain® after an FDA Incomplete Letter and redirecting resources to the First Defense® franchise. The company expects a non‑cash impairment of about $2.3M against Re‑Tain® assets with a $15.5M net book value, while expanding sales and manufacturing for First Defense®. Historically strong growth in First Defense® supports this focus, but execution on international expansion and manufacturing improvements will be key metrics to watch.

Key Terms

new animal drug application (nada) regulatory

"received an Incomplete Letter from the FDA for its Re-Tain® New Animal Drug Application (NADA)"

A New Animal Drug Application (NADA) is the formal submission to the U.S. regulatory agency asking permission to market a new drug for animals, backed by evidence that the product is safe, effective, and can be reliably manufactured. For investors, NADA approval is a key milestone because it grants legal market access, can create exclusive selling rights or a competitive edge, and is often the trigger for revenue generation or licensing opportunities.

mastitis medical

"claims for preventing and treating mastitis in dairy cows"

Mastitis is an inflammation or infection of the mammary gland or breast tissue, most commonly seen in breastfeeding humans and milk-producing animals; it typically causes pain, swelling and reduced milk output. Investors should care because outbreaks or ongoing cases can cut milk supply in dairy operations, increase demand for drugs and veterinary services, raise treatment and compliance costs, and affect revenue — like a kink in a supply hose that reduces flow and raises repair bills.

total addressable market financial

"the estimated $900 million worldwide Total Addressable Market for preventing scours"

Total addressable market is the total potential sales opportunity for a product or service if it were to reach every possible customer. It helps investors understand the maximum size of the market and the growth potential for a business. Think of it as the entire pie available to be shared, indicating how big the opportunity could be.

colostrum medical

"based on proprietary colostrum hyper-immunization technology"

Colostrum is the nutrient- and antibody-rich first milk produced by mammals in the hours and days after birth, like a concentrated starter pack of immune defenses and growth factors for newborns. Investors care because colostrum is a raw material and active ingredient in dairy, animal-health, and dietary-supplement markets, and its sourcing, quality, and regulatory status can affect product claims, manufacturing costs and market demand much like a key crop or commodity.

hyper-immunization medical

"based on proprietary colostrum hyper-immunization technology"

Hyper‑immunization is the practice of giving extra vaccine or antibody doses to an individual or animal to produce unusually high levels of protective antibodies, or the process of creating high‑titer antibody products for treatments and tests. Investors should care because hyper‑immunized products are specialized, often higher‑value medical goods with distinct production, regulatory and safety considerations — like charging a battery to full capacity to power demanding devices, which can affect manufacturing costs, market size and pricing.

non-cash impairment write-down financial

"expects to record a non-cash impairment write-down of property, plant and equipment"

A non-cash impairment write-down is an accounting adjustment that reduces the recorded (book) value of an asset when that value is judged to be higher than what the asset can realistically be expected to earn or be sold for. It does not involve spending cash now, but it lowers reported profits and equity on the balance sheet, so investors watch it as a signal that past investments are worth less and future earnings or credit terms could be affected.

net realizable value financial

"after a review of alternate purposing and net realizable value is completed"

Net realizable value is the estimated amount a company expects to receive from selling an asset—typically inventory or a receivable—after subtracting any costs needed to finish, sell, or collect it. For investors it shows whether assets on the balance sheet are likely to convert into cash at their stated value, much like estimating how much you’d actually get from a garage sale after cleaning and listing fees; large gaps can signal future write-downs or weaker earnings.

AI-generated analysis. Not financial advice.

PORTLAND, Maine, Dec. 24, 2025 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell”), an animal health company that develops, manufactures and markets products that improve cattle health and productivity today announced that it received an Incomplete Letter from the United States Food and Drug Administration (FDA) on December 23, 2025 for its Re-Tain^® New Animal Drug Application (NADA), and simultaneously that it is increasing its First Defense^® field sales force by 50% and expanding its First Defense^® manufacturing capabilities.

In seeking FDA approval to bring its innovative Re-Tain^® product to market, ImmuCell received Complete Letters from the FDA for four of the five Technical Sections required for NADA approval. It pursued a two-pronged manufacturing approach to reduce capital expenditure and limit technical risk for the remaining fifth Technical Section pertaining to manufacturing. ImmuCell manufactured the active pharmaceutical ingredient using a proprietary process in its own facility and hired an experienced contract manufacturer with FDA approvals for animal health products for the aseptic filling of the product into syringes. ImmuCell passed FDA inspection of its own facility in 2024. It is ImmuCell’s understanding that the FDA is now declining to approve the NADA because the contract manufacturer has not satisfactorily addressed inspectional deficiencies.

After considering the practical implications of the resulting delays, including the pending expiration of ImmuCell’s contract with the manufacturer in March 2026, ImmuCell has decided to pause further investment in Re-Tain^® and increase its investment in its market leading First Defense^® franchise, which it believes to have significant revenue and profit growth capacity.

ImmuCell will complete ongoing investigational studies with Re-Tain^® to assess opportunities for an improved set of claims for preventing and treating mastitis in dairy cows. It will seek to license the product to interested parties or, depending on the outcome of the studies, may seek to partner with a global manufacturer. Neither approach would require further capital investment or in-house manufacturing capability, meaning that ImmuCell will prioritize cash and other resources for maximizing the value of its market leading First Defense^® franchise.

“While it is disappointing news that we will be unable to achieve NADA approval with this contract manufacturer, this has only strengthened our resolve to allocate our resources to our highest return opportunity, namely First Defense^®,” said Olivier te Boekhorst, President and Chief Executive Officer of ImmuCell. “We will focus on maximizing our opportunities in the estimated $900 million worldwide Total Addressable Market for preventing scours in calves. Based on feedback from customers about our products and our ongoing internal assessment of potential manufacturing efficiencies, we believe there is significant runway for top-line growth and margin expansion for First Defense^® that would drive sustainable profit growth for ImmuCell.”

ImmuCell’s First Defense^® product line is based on proprietary colostrum hyper-immunization technology, offering a unique range of products with considerable growth potential. The brand holds strong leadership in the U.S. market, shown by its #1 ranking for scour-prevention in the 2025 Hoard’s Dairyman Continuing Market Study and its 29% share of U.S. spend on scours prevention, and targets a sector where high calf values present significant opportunities in dairy and beef industries. ImmuCell believes it is in a favorable position to expand sales internationally and to develop new products by harnessing the special antibody-rich and bioactive properties of colostrum.

“As a result of this strategic change in focus, ImmuCell expects to record a non-cash impairment write-down of property, plant and equipment during the fourth quarter of 2025. As previously disclosed, net book value of Re-Tain^® assets was approximately $15.5 million as of September 30, 2025. We are anticipating adjustments to laboratory and manufacturing equipment and construction in progress, resulting in an estimated non-cash impact to profit of approximately $2.3 million. The final figure for this non-cash expense will be determined after a review of alternate purposing and net realizable value is completed as part of the financial closing for the quarter and year ending December 31, 2025,” says Timothy Fiori, Chief Financial Officer. “We plan to repurpose facilities and a large portion of the equipment for the expansion of First Defense^® capacity to maximize return on these assets.”

“We are pleased to announce immediate steps toward First Defense^® commercial and manufacturing expansion,” added Mr. te Boekhorst. “We have created two new sales territories in the U.S., and we are hiring a senior dairy executive to execute our international strategy. We have also started a multi-year manufacturing improvement program to lower product costs, improve manufacturing yields, and execute our next phase of capacity expansion. Customer feedback and our own market assessments give us confidence that this is the right time for further investment in First Defense^®.”

David S. Tomsche, DVM, Chair of the ImmuCell Board of Directors, commented, “Fifteen years ago, ImmuCell established a small field team that grew First Defense^® annual revenue from approximately $4.4 million then to approximately $27.8 million in the trailing twelve-month period ended September 30, 2025. First Defense^®’s record of more than 13% compounded growth per year for more than a decade gives us confidence that focusing on and investing more in First Defense^® can deliver strong shareholder value.”

ImmuCell expects to announce its topline revenue results for the quarter and year ending December 31, 2025 on Thursday, January 8, 2026. ImmuCell expects to host a conference call to discuss revenue results and certain balance sheet activities on Friday, January 9, 2026 at 9:00 AM ET. ImmuCell expects to announce its full financial results for the year ending December 31, 2025 on Wednesday, February 25, 2026. ImmuCell expects to host a conference call to discuss its financial results for the year ending December 31, 2025 on Thursday, February 26, 2026 at 9:00 AM ET.

Cautionary Note Regarding Forward-Looking Statements (Safe Harbor Statement):

This Press Release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and often include words such as “expects”, “may”, “anticipates”, “aims”, “intends”, “would”, “could”, “should”, “will”, “plans”, “believes”, “estimates”, “targets”, “projects”, “forecasts”, “seeks” and similar words and expressions. Such statements include, but are not limited to, any forward-looking statements relating to: our plans, goals and strategies for our business; the expected timing of key future events; future operational performance and financial results; future demand for our products; the timing and outcome of pending or anticipated applications for regulatory approvals; and any other statements that are not historical facts. Such statements involve known and unknown risks and uncertainties that may cause ImmuCell’s actual results, financial or operational performance or achievements to be materially different from those expressed or implied by these forward-looking statements. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

About ImmuCell:

ImmuCell Corporation’s (Nasdaq: ICCC) purpose is to create scientifically proven and practical products that improve the health and productivity of dairy and beef cattle. ImmuCell manufactures and markets First Defense^®, which provides Immediate Immunity™ to newborn dairy and beef calves. Press releases and other information about ImmuCell are available at: http://www.immucell.com.

Contacts:	Olivier te Boekhorst, President and CEO
	Timothy Fiori, Chief Financial Officer
	ImmuCell Corporation
	investor.relations@ImmuCell.com
	Joe Diaz, Robert Blum and Joe Dorame
	Lytham Partners, LLC
	iccc@lythampartners.com

FAQ

What did ImmuCell announce about Re-Tain on December 23, 2025 (ICCC)?

ImmuCell said it received an FDA Incomplete Letter for Re-Tain after one manufacturing-related technical section was not satisfactorily addressed.

How is ImmuCell changing its strategy after the FDA letter for Re-Tain (ICCC)?

The company is pausing further Re-Tain investment, completing studies, seeking licensing/partnerships, and reallocating resources to First Defense.

What immediate investments is ImmuCell making in First Defense (ICCC)?

ImmuCell is increasing the First Defense field sales force by 50%, expanding manufacturing capacity, and hiring a senior dairy executive for international strategy.

What is the expected financial impact from pausing Re-Tain (ICCC)?

ImmuCell expects a ~$2.3M non-cash impairment in Q4 2025; Re-Tain net book value was about $15.5M as of Sept 30, 2025.

How large is the market opportunity ImmuCell cites for First Defense (ICCC)?

ImmuCell cites an estimated worldwide total addressable market of $900 million for preventing scours in calves.

When will ImmuCell report revenue and full-year 2025 financial results (ICCC)?

Topline revenue for quarter/year ending Dec 31, 2025 is expected on Jan 8, 2026 (call Jan 9); full year results on Feb 25, 2026 (call Feb 26).