PORTLAND, Maine, June 25, 2025 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically proven and practical products that improve the health and productivity of dairy and beef cattle, today announced that it has commenced a search for a successor in the position of President and CEO. “I turn 65 this fall and have told my fellow Directors that I would like to retire from full-time work by ear ...

Summary of ImmuCell Corporation Conference Call Company Overview - **Company**: ImmuCell Corporation (Ticker: ICCC) - **Industry**: Animal Health, specifically focusing on products that reduce antibiotic use in livestock [1][2] Core Products and Market Position - **First Defense**: A USDA licensed product aimed at providing immediate immunity to newborn calves, reducing the need for traditional antibiotics [3][5][17] - **Retain**: A novel alternative to traditional antibiotics for treating mastitis, currently in the investigational phase due to FDA approval delays [6][38] - **Market Dynamics**: The company positions itself against competitors by emphasizing immediate immunity rather than delayed responses typical of vaccines [17][19] Sales and Financial Performance - **Historical Growth**: From 2011 to 2018, the company experienced an 11.6% CAGR, which accelerated to 15.8% CAGR from 2018 to 2024 following the launch of Tri Shield [12][14] - **Recent Sales Data**: Q1 2024 revenue was $8.1 million, with trailing twelve-month growth reaching $27.3 million, indicating strong recovery from previous production issues [14][15] - **Production Capacity**: The company has successfully doubled its production capacity to over $30 million annually and has been operating without contamination issues since April 2024 [16][15] Operational Challenges and Strategies - **Contamination Issues**: The company faced contamination problems during capacity expansion in late 2022 and throughout 2023, which limited supply [15][16] - **Backlog Management**: The backlog of orders was reduced from over $4 million to just over $3 million, with expectations to clear it in the upcoming quarters [27][28] - **Capital Expenditures**: Plans to increase production capacity from 30 million to 40 million annually, requiring approximately $3 million in capital expenditures [29][30] Product Development and Future Outlook - **First Defense Product Suite**: The product line has evolved since its initial approval in 1991, with the introduction of new formulations to enhance efficacy [34][35] - **Retain Investigational Use**: The company is initiating investigational use of Retain to gather field data, which is crucial for future strategic decisions [39][40] - **Gross Margin Improvement**: Gross margins improved from 22% during contamination issues to 42% in Q1 2025, with a target of reaching 45% [42][45] Strategic Financial Tools - **At-the-Market (ATM) Offering**: The company has utilized the ATM offering judiciously, with significant activity in 2024 but minimal in 2025, allowing for flexibility in financing [31][33] Conclusion - **Optimistic Outlook**: The management expresses optimism for the latter half of 2025, focusing on growth in First Defense and resolving strategic options for Retain [45]

Core Insights - ImmuCell Corporation reported a strong financial performance for Q1 2025, with record product sales of $8.1 million, an 11% increase from $7.3 million in the prior-year period [2] - The company achieved a net income of $1.45 million, a significant turnaround from a net loss of $438,000 in the same quarter a year ago, driven by sales growth and gross margin expansion [2] - Adjusted EBITDA for the quarter rose sharply to $2.3 million from $458,000 in the prior-year quarter, indicating improved operational efficiency [4] Revenue & Earnings - Product sales reached a record $8.1 million, up 11% year-over-year from $7.3 million [2] - Net income improved to $1.45 million from a loss of $438,000, with earnings per share increasing to 16 cents from a loss of 6 cents [2] - Adjusted EBITDA for the quarter was $2.3 million, up from a loss of $458,000 in the prior-year quarter [4] Business Metrics - Gross margin improved to 42% from 37% in Q4 2024, reflecting operational normalization after previous disruptions [3] - The company has successfully remediated contamination issues that affected prior quarters, leading to better manufacturing efficiencies [9] Product Performance - First Defense, the flagship product line, accounted for the majority of sales, with Tri-Shield representing 71% of First Defense product sales for the quarter [5] - Customer demand for Tri-Shield has increased significantly, attributed to its strong efficacy claims compared to traditional vaccines [9] Management Insights - CEO Michael Brigham noted the company's growth in complexity and diversification, supported by the strength of First Defense and increased production capacity [6] - New CFO Tim Fiori emphasized cost control and operational improvements as key drivers for long-term profitability [7] Future Outlook - The company expects continued sales growth due to backlog reduction and increased production capability [11] - ImmuCell is in the investigational phase for the Re-Tain product, which will provide valuable field feedback for future commercialization strategies [11] - A $4-million investment for in-house formulation and aseptic filling for Re-Tain has been paused pending clarity on FDA licensing timelines [12]

Financial Data and Key Metrics Changes - Product sales for the first quarter of 2025 increased by 11% or $810,000 to a record $8,100,000 compared to the first quarter of 2024 [9] - The twelve-month period ended 03/31/2025 saw a 28% increase in product sales, amounting to $27,300,000 compared to the previous year [10] - Adjusted EBITDA for the three, six, and twelve-month periods ended 03/31/2025 was $2,300,000, $3,700,000, and $3,300,000 respectively, showing significant improvement from the previous year [12] Business Line Data and Key Metrics Changes - The sales mix for Tri Shield constituted 71% of total sales in the latest quarter, up from 55% in the previous quarter [17] - The company is developing a new bulk powder product, expected to be launched in the latter half of 2025, which will serve as a seed additive for large ranches [20] Market Data and Key Metrics Changes - The order backlog decreased from $4,400,000 as of 12/31/2024 to $4,000,000 as of 03/31/2025, and further reduced to $3,400,000 by 05/06/2025 [9] Company Strategy and Development Direction - The company is focused on expanding its product offerings and increasing production capacity, with investments exceeding $30,000,000 to enhance production facilities [6] - Management emphasizes the importance of avoiding contamination events and maintaining strong production yields to drive cash flows [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's trajectory for the remainder of 2025, highlighting the positive sales growth and improved cash balance [6] - The company is currently in a recovery phase, with expectations for continued growth driven by increased production capacity and backlog clearance [39] Other Important Information - The company has not experienced any contamination events for over a year, which is crucial for maintaining production efficiency [6] - The introduction of investigational product use for Repayne aims to gather market feedback while minimizing product development costs [7] Q&A Session Summary Question: Inquiry about product mix and its impact on gross margin - Management confirmed that Tri Shield has been a significant driver of growth due to its broader claims and efficacy, and while the bulk powder product is still in development, it is expected to contribute positively in the future [19][20] Question: Clarification on EBITDA erosion from past contamination events - Management indicated that the last contamination event occurred in April 2024, affecting primarily the first quarter of that year, with a revenue rebound starting in the fourth quarter of 2024 [30][35] Question: Expectations for future revenue and EBITDA - Management suggested that the core business EBITDA run rate is expected to be higher than the reported figures due to improved operational conditions and backlog clearance [40][41] Question: Discussion on product development expenses and their impact on EBITDA - Management acknowledged that significant investments in product development are impacting current EBITDA but are necessary for future growth and product approvals [45][50] Question: Difference between investigational use and commercial approval - Management explained that investigational use allows for product testing and data collection without generating revenue, while awaiting full FDA approval [61][62]

Financial Data and Key Metrics Changes - Product sales for the first quarter of 2025 increased by 11% or $810,000 to a record $8,100,000 compared to the first quarter of 2024, surpassing the previous record set in the fourth quarter of 2024 [9] - The gross margin improved to 42% in the first quarter of 2025, up from 37% in the fourth quarter of 2024, although the target remains at 45% or more [11] - Adjusted EBITDA for the three months ended 03/31/2025 was $2,300,000, a significant increase from $705,000 in the same period of 2024 [12] Business Line Data and Key Metrics Changes - The sales mix for Tri Shield constituted 71% of total sales in the latest quarter, up from 55% in the previous quarter, indicating strong demand for this product [17] - The company is developing a new bulk powder product, expected to be launched in the latter half of 2025, which will target large ranches [20] Market Data and Key Metrics Changes - The order backlog decreased from $4,400,000 as of 12/31/2024 to $4,000,000 as of 03/31/2025, and further reduced to $3,400,000 as of 05/06/2025, indicating improved sales performance [9] Company Strategy and Development Direction - The company is focused on expanding its product offerings and increasing production capacity, having completed investments to boost production capacity to over $30,000,000 per year [6] - Management emphasized the importance of avoiding contamination events and maintaining strong production yields to drive cash flows [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's trajectory for the remainder of 2025, highlighting the complexity of managing a growing and diverse business [8] - The company is currently utilizing investigational product use of Repayne to gather market feedback while minimizing product development costs [7] Other Important Information - The company has not experienced any contamination events for over a year, which has positively impacted production and sales [6] - The new CFO, Tim Fiori, brings extensive experience from IDEXX Laboratories, which is expected to enhance financial operations [8] Q&A Session Summary Question: Inquiry about product mix and Tri Shield sales - Management confirmed that Tri Shield has been a significant driver of growth due to its broader claims and efficacy [19] Question: Expectations for new bulk powder product - The bulk powder product is still in development, with no sales reported yet, but is expected to launch in the second half of 2025 [20] Question: Clarification on EBITDA erosion from past contamination events - Management indicated that the last contamination event occurred in April 2024, affecting the previous year's EBITDA, but strong sales have rebounded since then [32][34] Question: Future revenue expectations - Management noted that the second quarter is expected to benefit from clearing the backlog and increased production capacity, although specific revenue projections were not provided [38] Question: Investigational product use versus commercial approval - The investigational use allows the company to gather data without generating revenue, while awaiting full FDA approval [58] Question: Impact of profitability on share sales - Management acknowledged that profitability is a factor in share sales, but capital needs for growth and obligations remain considerations [59] Question: Future projections for the company - Management expressed caution in providing specific projections due to the variability in sales and market conditions, emphasizing the importance of tracking performance [67]

Company Overview and Strategy - ImmuCell Corporation focuses on growth in First Defense product line sales and aims to revolutionize subclinical mastitis treatment with Re-Tain[10] - The company addresses the $2 billion annual economic harm to the dairy industry caused by mastitis without traditional antibiotics, using Re-Tain (subject to FDA approval)[10, 53] - Three critical action items include growing First Defense sales, achieving FDA approval for Re-Tain, and proving market acceptance of Re-Tain with $10 million annual production capacity[18] - The company completed an investment to increase First Defense production capacity to over $30 million in annual sales value[29, 49] Product Lines and Market Opportunities - The U S market opportunity for calf-level products to prevent scours is approximately $31 1 million annually[32, 51] - The U S market opportunity for calf-level and dam-level vaccine products used to prevent scours is estimated at $81 8 million annually[32, 51] - Mastitis causes an estimated $2 billion in economic loss to the dairy industry each year[33, 52] Financial Performance - As of March 31, 2025, the company's cash and cash equivalents were $4 6 million, and total assets were $45 6 million[83] - For the three-month period ended March 31, 2025, product sales were $8 1 million, with a gross margin of 42%[87] - The company's total project cost for First Defense is estimated at $14 177 million, and for Re-Tain, it's $5 382 million[90]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 | | | Name of each exchange on which | | --- | --- | --- | | Title of each class | Trading symbol(s) | registered | | Common Stock, $0.10 par value per share | ICCC | The Nasdaq Capital Market | Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Sec ...

Core Viewpoint - ImmuCell Corporation reported record product sales and net income for the first quarter of 2025, indicating strong growth and operational improvements in the animal health sector [4][8]. Financial Performance - Product sales for Q1 2025 reached approximately $8.1 million, an increase of 11% compared to Q1 2024 [8]. - For the six-month period ending March 31, 2025, product sales increased by 28% to approximately $15.8 million compared to the same period in 2024 [8]. - Over the twelve-month period ending March 31, 2025, product sales also rose by 28% to approximately $27.3 million compared to the previous year [8]. - The gross margin improved to 42% in Q1 2025 from 37% in Q4 2024 [4]. - Net income for Q1 2025 was approximately $1.4 million, or $0.16 per diluted share, compared to a net loss of $438,000, or ($0.06) per basic share, in Q1 2024 [9]. Balance Sheet Highlights - Cash and cash equivalents increased to $4.6 million as of March 31, 2025, up from $3.8 million as of December 31, 2024 [9]. - Net working capital rose to approximately $12.1 million as of March 31, 2025, compared to $10.6 million at the end of 2024 [9]. - Stockholders' equity increased to $29 million as of March 31, 2025, from $27.5 million as of December 31, 2024 [9]. Operational Insights - The company is focused on reducing order backlogs and improving gross margins as production output increases [4]. - ImmuCell is advancing the Investigational Product use of Re-Tain to gather market feedback on product performance during the second half of 2025 [4]. - The company is also reducing product development expenses and exploring strategic options for its technology [4].

Core Insights - ImmuCell Corporation is set to report unaudited financial results for Q1 2025 on May 14, 2025, after market close [1][3] - A conference call to discuss these results is scheduled for May 15, 2025, at 9:00 AM ET [2] - The company anticipates no changes to preliminary sales results disclosed on April 8, 2025 [3] Company Overview - ImmuCell focuses on developing and marketing products that enhance the health and productivity of dairy and beef cattle [5] - The company manufactures First Defense, which provides Immediate Immunity™ to newborn calves, and is developing Re-Tain, a treatment for subclinical mastitis in dairy cows [5] Investor Information - Investors can access an updated Corporate Presentation slide deck on the company's website, which will be available after market close on May 14, 2025 [4]

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