ImmuCell Posts Y/Y Q4 Earnings Growth, Awaits FDA Approval for Re-Tain

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By Ronald Tech

Shares of ImmuCell Corporation ICCC have gained 6.5% since the company reported earnings for the fourth quarter of 2024. This compares with the S&P 500 index’s 0.6% dip over the same time frame. Over the past month, the stock has lost 0.4% compared with the S&P 500’s 2.2% decline.

Strong Revenue Growth & Improved Profitability

ImmuCell reported fourth-quarter 2024 earnings per diluted share of 6 cents against the loss of 15 cents incurred in the prior-year quarter.

The company’s total quarterly product sales of $7.8 million marked a 52% increase from $5.1 million in the same period of 2023. For the year, product sales rose 52% to $26.5 million from $17.5 million in 2023. The company attributed this surge to the recovery from prior production constraints related to contamination events.

The gross margin improved significantly from 25% in the fourth quarter of 2023 to 37% in the fourth quarter of 2024. This expansion in profitability helped ImmuCell swing to a net income of $515,000 for the quarter from a net loss of $1.14 million in the year-ago quarter. However, on a full-year basis, the company incurred a net loss of $2.16 million, narrower than the $5.78 million net loss recorded in 2023.

The company’s earnings before interest, taxes, depreciation and amortization (EBITDA) was $1.33 million in fourth-quarter 2024 against the negative of $311,000 registered in fourth-quarter 2023. For 2024, EBITDA was $1.1 million, a significant improvement from the negative $2.58 million reported in 2023.

ImmuCell Corporation Price, Consensus and EPS Surprise

 

ImmuCell Corporation Price, Consensus and EPS Surprise

ImmuCell Corporation price-consensus-eps-surprise-chart | ImmuCell Corporation Quote

Operational Progress & Key Business Metrics

ImmuCell has maintained uninterrupted production since April 2024, following a period of contamination-related setbacks. The company has made operational improvements aimed at increasing production efficiency and avoiding future disruptions. Management has emphasized that production capacity has scaled to support more than $30 million in annual revenues, and further operational refinements are expected to enhance the gross margin beyond 40%.

On the balance sheet, cash and cash equivalents rose to $3.8 million at the end of 2024 from $979,000 a year earlier. The company has no outstanding balance on its $1-million credit line, and net working capital improved to $10.6 million from $7.3 million. Stockholders’ equity also increased, reaching $27.5 million from $25 million in 2023.

Management Commentary & Strategic Priorities

CEO Michael Brigham expressed confidence in the company’s ongoing recovery and highlighted the role of strong sales momentum and margin expansion in stabilizing financial performance. He has acknowledged that while the production mix and higher costs have pressured margins, the company has been implementing pricing adjustments and efficiency measures to drive improvements.

Brigham has also emphasized that the company’s growth strategy is centered around its flagship First Defense product line, which has gained market share in the calf health segment. Tri-Shield, a key product variant with E. coli, coronavirus and rotavirus claims, has been a major growth driver, though its higher production costs have influenced overall margins.

Factors Influencing Performance

Robust revenue growth in the fourth quarter of 2024 was largely a result of ImmuCell’s ability to resolve prior manufacturing challenges and fulfill outstanding orders. The company experienced a prolonged backlog due to contamination issues, which constrained sales in 2023. With production back on track, sales volumes improved significantly.

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However, management has acknowledged that gross margin expansion has been progressing. While a 37% gross margin in fourth-quarter 2024 represented a strong recovery, it remained below the historical 40-45%. Factors such as product mix (higher sales of the more expensive to produce Tri-Shield) and industry-wide cost pressures have influenced margins. The company has implemented a price increase for 2025, which is expected to support profitability.

Outlook & Regulatory Developments

A key catalyst for ICCC is the potential FDA approval of Re-Tain, its novel treatment for subclinical mastitis. The company submitted its Non-Administrative New Animal Drug Application to the FDA in early January 2025, incorporating all required technical sections. Brigham has stated that the company has been seeking expedited review, intending to launch a controlled distribution phase following regulatory clearance.

Re-Tain is designed as an alternative to traditional antibiotics used for mastitis treatment, with the advantage of not requiring milk discard or meat withhold restrictions. Given the economic impact of mastitis on dairy operations, estimated at $2 billion annually, management views Re-Tain as a transformative product that could unlock revenue streams.

In parallel, ImmuCell is exploring options to offset product development costs and optimize the broader market rollout of Re-Tain. The company is also assessing additional international market opportunities for its First Defense product line.

Other Developments

In the quarter, ICCC continued its capital investment strategy, though at a more measured pace. The company has deferred certain expenditure, including an estimated $5 million investment to expand production capacity beyond its current $30-million annual revenue threshold. Management noted that further capacity upgrades would be revisited based on demand trends and regulatory progress for Re-Tain.

Additionally, ImmuCell has initiated preliminary steps to introduce a bulk feed format for its colostrum-derived antibody product. While this initiative is in its early stages, the company believes that it can provide a pathway to further commercial utilization of its production capacity.

Conclusion

ICCC’s fourth-quarter 2024 results reflect a significant operational turnaround, driven by strong sales recovery and improving profitability. While the company continues to face margin pressures and regulatory hurdles, it has made substantial progress in stabilizing its business and positioning itself for growth. With potential FDA approval of Re-Tain on the horizon and continued strength in First Defense sales, 2025 could be a pivotal year for the company’s expansion efforts.

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