ImmuCell Q2 2025 slides: sales momentum continues as Re-Tain awaits FDA approval

Introduction & Market Context

ImmuCell Corporation (NASDAQ:ICCC) presented its latest investor update on May 15, 2025, highlighting continued sales momentum and strategic positioning in the animal health sector. The company, which focuses on dairy and beef cattle health solutions, has maintained strong growth following its impressive 52% year-over-year sales increase reported for Q4 2024.

ImmuCell’s business model addresses two critical challenges in livestock management: scours (intestinal infections) in newborn calves and mastitis in dairy cows. The company emphasizes its role in reducing antibiotic use in food production while improving animal health outcomes, positioning itself at the intersection of food safety and agricultural productivity.

As shown in the company overview slide, ImmuCell operates from two company-owned facilities: a USDA-regulated production facility for First Defense and an FDA-regulated facility for Re-Tain.

Quarterly Performance Highlights

ImmuCell’s recent financial performance has been robust, with the company’s Q4 2024 results showing revenue of $7.8 million, representing a 52% increase compared to the same period in 2023. This growth trajectory appears to be continuing into 2025, supported by the company’s expanded production capacity for its First Defense product line.

Gross margin performance has been particularly impressive, with Q4 2024 showing a 125% year-over-year increase to $2.8 million. The company’s EBITDA turned positive at $1.3 million, compared to a loss of $311,000 in Q4 2023. These improvements reflect both sales growth and operational efficiencies.

The company’s cash position strengthened from $979,000 to $3.8 million, bolstered by a $4.4 million capital raise through an at-the-market offering. This improved financial position supports ImmuCell’s ongoing expansion and product development initiatives.

In after-hours trading following the presentation, ImmuCell’s stock showed significant movement, rising 20.16% to $5.90, building on the 6.92% gain reported after the Q4 2024 earnings announcement.

Strategic Initiatives

ImmuCell has outlined three critical strategic priorities: significantly growing sales of the First Defense product line, achieving FDA approval for Re-Tain, and proving market acceptance of Re-Tain with the current $10 million worth of annual production capacity.

The company has systematically expanded its First Defense production capacity, with major expansions coming online in Q4 2021, July 2023, and throughout 2024. This expansion addresses previous order backlogs and positions the company for continued growth.

The following slide illustrates ImmuCell’s market disruption strategy for both product lines, highlighting how First Defense provides an alternative to maternal vaccines while Re-Tain offers mastitis treatment without milk discard requirements:

Re-Tain represents a potentially transformative product for the dairy industry, addressing an estimated $2 billion annual economic harm from mastitis infections without using traditional antibiotics that are also used in human medicine. The regulatory pathway for Re-Tain continues to progress, with ImmuCell submitting its Non-Administrative NADA (New Animal Drug Application) to the FDA in January 2025, which included the fourth submission of the CMC Technical Section along with All Other Information and Product Labeling.

Competitive Industry Position

ImmuCell positions itself as a disruptor in animal health, particularly in the dairy sector. The company’s approach focuses on solving two major problems for dairy systems – scours and mastitis – while reducing dependence on antibiotics.

The company’s presentation highlights the nutritional and economic advantages of dairy compared to plant-based alternatives, emphasizing milk’s superior protein content (8g per cup) and lower cost ($0.19 per cup) compared to alternatives like almond juice (1g protein, $0.50-$0.63) or oat juice (4g protein, $0.63).

ImmuCell is also exploring growth opportunities beyond its core markets, including international expansion and applications for small ruminants like goats and sheep. This diversification strategy could provide additional growth avenues beyond the company’s current focus.

The following slide outlines ImmuCell’s broader role in the agricultural ecosystem, highlighting its contribution to food chain improvement and animal productivity:

Forward-Looking Statements

Looking ahead, ImmuCell’s growth strategy hinges significantly on the FDA approval process for Re-Tain. During May 2024, the FDA issued a Technical Section Incomplete Letter in response to the company’s third submission of the CMC Technical Section, prompting the January 2025 resubmission.

CEO Michael Brigham has expressed optimism about the company’s trajectory, noting in the Q4 2024 earnings call that "We remain poised and excited to revolutionize the way that subclinical mastitis is treated in today’s dairy market" with Re-Tain.

The company aims to achieve a $30 million annual production capacity, signaling ambitious growth plans. However, investors should note that regulatory approval timelines remain uncertain, and biological processing variability continues to pose challenges to yield consistency.

ImmuCell’s presentation and recent financial results suggest a company with strong momentum and strategic clarity, though the transformative potential of Re-Tain remains contingent on successful navigation of the regulatory approval process and subsequent market acceptance.

Full presentation:

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