ImmuCell estimates the worldwide total addressable market for scour protection at approximately $900 million. The company’s stated strategy is to increase customer engagement using “strong medical, scientific, and outcomes-based arguments” to drive adoption.Management pointed to changes in the economics of newborn calves as a key driver for increased demand for scour protection. Taboukos said calf values have risen substantially over the past five years, citing factors including beef-on-dairy cross-breeding ...

Financial Data and Key Metrics Changes - Product sales for Q4 2025 were $7.6 million, a decrease of 1.6% compared to Q4 2024, with domestic sales growing 8.7% to $7 million [12][13] - Full-year product sales for 2025 totaled $27.6 million, reflecting a growth of 4.3% compared to 2024 [14] - A non-cash impairment write-down of approximately $2.9 million is expected due to the shift in strategy regarding Re-Tain [15] Business Line Data and Key Metrics Changes - The First Defense product line saw a significant growth of 41.3% in Q4 2025 compared to Q4 2024, indicating strong demand [5] - There is a noted shift towards the Tri-Shield product within the First Defense suite, reflecting a migration from Dual-Force products [14] Market Data and Key Metrics Changes - Domestic sales showed an increase of 8.7%, while international sales declined by 52.6% in Q4 2025, primarily due to order timing in Canada [13][14] - The total addressable market for First Defense is estimated to be approximately $900 million worldwide, driven by increased calf values and the need for early-life calf health solutions [8] Company Strategy and Development Direction - The company is shifting its strategic focus to prioritize First Defense, pausing investments in Re-Tain due to regulatory challenges and a high confidence in First Defense's growth potential [6][7] - Plans include expanding the sales team by 50% and creating two new U.S. sales territories to drive growth in First Defense [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the future sales and profit growth potential of First Defense, emphasizing the importance of operational excellence and capacity expansion [17][18] - The company is optimistic about the ongoing investigational studies for Re-Tain, which are expected to provide valuable data for future partnerships [41] Other Important Information - The company is repurposing manufacturing assets from Re-Tain to support First Defense, which is expected to enhance production capacity without significant additional capital [6][11] - A write-down of approximately $600,000 is planned for inventory deemed unsuitable for requirements [16] Q&A Session Summary Question: Impact of regional pathogens on foreign sales development - Management acknowledged the complexity of international sales and the need for experienced personnel to navigate product requirements and market strategies [22] Question: Explanation for contract manufacturer's failure to comply with FDA requirements - Management declined to provide details but confirmed that the Incomplete Letter from the FDA was solely due to issues with the contract manufacturer [24][25] Question: Timeline for securing a strategic partner for Re-Tain - Management expressed confidence in the product's capabilities and indicated that they would seek partnerships after completing investigational studies in 2026 [28][41] Question: Clarity on the self-imposed milk discard period for Re-Tain - Management clarified that the discard period is necessary to avoid impacting cheese production, but it is still less than competitors' requirements [47][48] Question: Explanation for exceeding sales expectations - Management attributed the sales exceeding expectations to effective management practices and a strong commercial team, despite complexities from previous backorder situations [54][55]

Financial Data and Key Metrics Changes - The company reported product sales for Q4 2025 at $7.6 million, a decrease of 1.6% compared to Q4 2024, primarily due to a previous backorder situation that inflated sales in the prior year [12][13] - Domestic sales grew by 8.7% year-over-year to $7 million, while international sales declined by 52.6% due to order timing in Canada [13][14] - Full-year product sales for 2025 totaled $27.6 million, reflecting a 4.3% increase compared to 2024 [14] Business Line Data and Key Metrics Changes - The First Defense product line saw significant growth, with Tri-Shield experiencing a 41.3% increase in Q4 2025 compared to Q4 2024, indicating a shift from Dual-Force products [5][14] - The company is focusing on increasing manufacturing output for First Defense, achieving over a 15% increase in lyophilization output in 2025, with expectations for similar growth in 2026 [9][18] Market Data and Key Metrics Changes - The newborn calf market has evolved, with calf values increasing significantly, leading to a greater economic emphasis on early-life calf health and survival [8] - The total addressable market for scour protection is estimated at approximately $900 million worldwide, indicating substantial growth potential for First Defense products [8] Company Strategy and Development Direction - The company is shifting its strategic focus to First Defense, pausing investments in Re-Tain due to an Incomplete Letter from the FDA, which has delayed the product's approval process [6][7] - The strategy includes expanding the sales team by 50% and creating two new U.S. sales territories to drive growth in First Defense [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of First Defense, citing the need for increased focus and execution to capitalize on market opportunities [6][9] - The company plans to complete investigational studies for Re-Tain to prepare for potential partnerships, emphasizing that manufacturing in-house is not the best use of resources [11][41] Other Important Information - A non-cash impairment write-down of approximately $2.9 million is expected due to the shift in strategy regarding Re-Tain [15] - An estimated write-down of $600,000 for inventory deemed unsuitable for requirements has been planned [16] Q&A Session Summary Question: Impact of regional pathogens on foreign sales development - Management acknowledged the complexity of international sales and the need for experienced personnel to navigate product requirements and market strategies [21][22] Question: Explanation for contract manufacturer's failure to comply with FDA requirements - Management declined to provide details but confirmed that the Incomplete Letter was solely due to issues with the contract manufacturer [24][25] Question: Timeline for securing a strategic partner for Re-Tain - Management expressed confidence in the product's capabilities and indicated that they would seek partners after completing investigational studies in 2026 [28][41] Question: Clarity on the self-imposed milk discard period for Re-Tain - Management clarified that the discard period is necessary to prevent impact on cheese manufacturing processes, although it is less than competitors [46][48] Question: Explanation for exceeding sales expectations - Management attributed the sales exceeding expectations to effective management practices and a strong commercial team, despite complexities from previous backorder situations [52][55]

Financial Data and Key Metrics Changes - The company reported product sales for Q4 2025 at $7.6 million, a decrease of 1.6% compared to Q4 2024, with domestic sales growing 8.7% to $7 million [11][12] - Full-year product sales for 2025 totaled $27.6 million, reflecting a 4.3% increase compared to 2024 [12] - The company experienced a significant decline in international sales, particularly in Canada, which dropped 52.6% year-over-year in Q4 [12] Business Line Data and Key Metrics Changes - The First Defense product line saw a notable shift towards Tri-Shield, indicating a migration from Dual-Force products and attracting new dairy and beef customers [12] - Manufacturing output for the key bottleneck process, lyophilization, increased by more than 15% in 2025, with expectations for similar growth in 2026 [8][17] Market Data and Key Metrics Changes - The newborn calf market has evolved, with calf values increasing significantly, now worth approximately $1,300 on day one of life compared to roughly $200 in 2003, raising the economic stakes for early-life calf health [7] - The total addressable market for scour protection is estimated to be around $900 million worldwide [7] Company Strategy and Development Direction - The company is shifting its strategic focus to First Defense, pausing investment in Re-Tain due to an Incomplete Letter from the FDA regarding its new animal drug application [4][6] - The strategy includes expanding the sales team by 50% and creating two new U.S. sales territories to drive growth [16] - The company aims to repurpose manufacturing assets from Re-Tain to support First Defense, enhancing operational efficiency [10][14] Management's Comments on Operating Environment and Future Outlook - Management expressed high confidence in the future sales and profit growth potential of the First Defense business, justifying the strategic shift [5][6] - The company is focused on operational excellence to ensure consistent supply and quality of products, with plans to optimize manufacturing processes [16][17] Other Important Information - A non-cash impairment write-down of approximately $2.9 million is expected due to the shift in strategy regarding Re-Tain [14] - An estimated write-down of $600,000 was taken for inventory deemed unsuitable for requirements [15] Q&A Session Summary Question: Impact of regional pathogens on foreign sales development - Management acknowledged the complexity of international sales and the need for expertise in launching products in different markets, highlighting the importance of hiring experienced personnel [20] Question: Explanation for contract manufacturer's failure to comply with FDA requirements - Management declined to provide details but confirmed that the Incomplete Letter was solely due to issues with the contract manufacturer [22][23] Question: Realism of securing a strategic partner for Re-Tain - Management expressed confidence in the product's capabilities and the need to find the best go-to-market strategy post-investigational studies [27] Question: Timeline for hiring new sales team members - Management confirmed that hiring processes for new sales team members are underway, with expectations to complete them within the current quarter [31] Question: Future cash needs and potential share dilution - Management indicated that various funding options are available, including operating cash flow, loans, and capital raises, but declined to comment on specific plans [33] Question: Clarity on self-imposed milk discard period for Re-Tain - Management explained that the discard period is necessary to avoid impacting cheese manufacturing processes, but it remains less than competitors' requirements [44][45] Question: Explanation for exceeding sales expectations - Management attributed the sales exceeding expectations to effective management practices and a strong commercial team, despite complexities from previous backorder situations [49][50]

PORTLAND, Maine, Jan. 08, 2026 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), an animal health company that develops, manufactures and markets products that improve cattle health and productivity, today announced preliminary, unaudited sales results for the fourth quarter and full year of 2025. Since the first quarter of 2020, ImmuCell has been providing a preliminary look at its unaudited top line results soon after the close of the quarter and the Company expects to ...

Core Viewpoint - ImmuCell Corporation is shifting its strategic focus towards the First Defense product line and away from Re-Tain, with upcoming discussions on its unaudited sales results for 2025 [2][3]. Group 1: Strategic Changes - The company announced a strategic change in focus towards the First Defense product line on December 24, 2025 [2]. - The upcoming conference call on January 9, 2026, will address this strategic shift and the unaudited topline sales results for the fourth quarter and full year ended December 31, 2025 [3]. Group 2: Financial Results and Conference Calls - ImmuCell plans to release its full unaudited financial results for the quarter and year ended December 31, 2025, after the market closes on February 25, 2026 [4]. - A conference call to discuss these financial results is scheduled for February 26, 2026, at 9:00 AM ET [4]. Group 3: Company Overview - ImmuCell Corporation focuses on creating scientifically proven products that enhance cattle health and productivity, specifically through its First Defense product, which provides Immediate Immunity™ to newborn dairy and beef calves [5].

Core Insights - The Zacks Equity Research team has highlighted several stocks, including AbbVie Inc., The Coca-Cola Co., Chevron Corp., ImmuCell Corp., and Precipio, Inc., in their Analyst Blog [1][2]. AbbVie Inc. (ABBV) - AbbVie has outperformed the Zacks Large Cap Pharmaceuticals industry over the past year, with a share price increase of +31.6% compared to the industry’s +19.5% [4]. - The company has successfully managed the loss of exclusivity for Humira by launching new immunology drugs, Skyrizi and Rinvoq, which are performing well and expected to support revenue growth [4][5]. - AbbVie is returning to robust revenue growth in 2025, following the U.S. Humira loss of exclusivity, and has been actively acquiring companies to enhance its early-stage pipeline [5]. The Coca-Cola Co. (KO) - Coca-Cola's shares have outperformed the Zacks Beverages - Soft Drinks industry over the past year, with a gain of +14.5% compared to +10.5% for the industry [6]. - The company's performance is attributed to solid organic revenue growth, effective pricing strategies, and gains in global market share within the non-alcoholic ready-to-drink category [6][7]. - Ongoing innovation and digital transformation efforts are enhancing Coca-Cola's competitive edge, although the company faces challenges such as soft volumes in key regions and currency headwinds [7][8]. Chevron Corp. (CVX) - Chevron's shares have increased by +9.5% over the past year, while the Zacks Oil and Gas - Integrated - International industry has gained +16% [9]. - The acquisition of Hess has significantly improved Chevron's growth outlook by adding high-quality assets in regions like Guyana and the Gulf of Mexico [9]. - The Permian Basin remains a key asset for Chevron, driving consistent growth, although challenges such as lower crude realizations and regulatory issues in California temper optimism [10]. ImmuCell Corp. (ICCC) - ImmuCell has outperformed the Zacks Medical - Products industry with a share price increase of +26.3% compared to +1% for the industry [11]. - The company’s First Defense franchise leads the market in calf scours prevention, with Tri-Shield accounting for 70% of volume and a 48% market share [11][12]. - ImmuCell has resolved operational bottlenecks, restoring capacity to $30 million in annual sales, with TTM revenues of $27.8 million, reflecting a 16% year-over-year increase [12][13]. Precipio, Inc. (PRPO) - Precipio's shares have surged by +361.2% over the past year, significantly outperforming the Zacks Medical Info Systems industry, which saw a decline of -1.3% [14]. - The company is moving towards self-funded growth, driven by its Pathology Services division, which is experiencing steady organic growth and rising margins [14][15]. - Precipio has improved profitability and cash flow, although it faces risks related to liquidity and regulatory uncertainties [15][16].

Core Viewpoint - ImmuCell Corporation has received an Incomplete Letter from the FDA regarding its Re-Tain New Animal Drug Application, prompting the company to shift focus towards expanding its First Defense product line, which is expected to drive significant revenue growth [1][2][5]. Group 1: FDA Approval and Manufacturing - ImmuCell received Complete Letters for four out of five Technical Sections required for NADA approval but faced issues with the contract manufacturer related to inspectional deficiencies [2]. - The company had adopted a dual manufacturing strategy to mitigate capital expenditure and technical risks, involving both in-house production and a contract manufacturer [2]. - ImmuCell's facility passed FDA inspection in 2024, but the contract manufacturer's deficiencies led to the current Incomplete Letter [2]. Group 2: Strategic Shift and Investment - Due to delays and the impending expiration of the contract with the manufacturer in March 2026, ImmuCell has decided to pause further investment in Re-Tain and instead increase investment in its First Defense franchise [3][4]. - The First Defense product line is expected to benefit from significant revenue and profit growth, with a focus on the $900 million global market for preventing scours in calves [5]. - ImmuCell plans to repurpose facilities and equipment from the Re-Tain project to enhance First Defense capacity, anticipating a non-cash impairment write-down of approximately $2.3 million [6][7]. Group 3: Market Position and Growth Potential - First Defense has shown strong market performance, with annual revenue growth from approximately $4.4 million to $27.8 million over the past fifteen years, reflecting a compounded growth rate of over 13% per year [7]. - The product line holds a 29% share of the U.S. market for scours prevention and is positioned for international expansion and new product development [5][7]. - Customer feedback and market assessments indicate a favorable environment for further investment in First Defense, which leverages proprietary colostrum hyper-immunization technology [5][7].

Core Insights - ImmuCell Corporation (ICCC) focuses on innovative cattle-health solutions that reduce reliance on traditional antibiotics while addressing calf scours and cow mastitis [1][3][4] Company Overview - ImmuCell is dedicated to creating scientifically proven products that enhance the health and productivity of dairy and beef cattle, targeting significant challenges in dairy systems [3] - The company positions itself as a "non-Pharma pharma" innovator, utilizing novel active ingredients rather than conventional antibiotics or vaccines [4] Product Offerings - **First Defense**: This product provides immediate immunity to newborn calves, helping to prevent scours and supporting herd productivity without requiring dam-level vaccine injections [7][8] - **Re-Tain**: A novel Nisin-based therapy for subclinical mastitis, designed to avoid human-use antibiotics, potentially saving the dairy industry approximately $2 billion annually [9][10] Market Performance - ImmuCell's stock has increased by 17.4% over the past year, outperforming the industry composite's decline of 0.7% and the S&P 500's growth of 15.1% [2] Customer Validation - Positive testimonials from producers and veterinarians highlight the efficacy and ease of administration of First Defense, with reports of scours incidence dropping by 75% after its adoption [11][12][13] Operational Strength - The company has invested in specialized manufacturing infrastructure, operating a USDA facility for First Defense and an FDA facility for Re-Tain, ensuring quality control and scalability [14] - Recent capacity expansions have increased First Defense's annual capacity to approximately $30 million, with further expansion options available [15][16] Financial Performance - For the nine months ending September 30, 2025, ImmuCell reported a net income of $1.8 million, a significant turnaround from a net loss of $2.7 million in the previous year, driven by higher sales and improved margins [17][18] - The gross margin improved to around 43% from 27% year-over-year, indicating enhanced production efficiency [18]

Core Viewpoint - ImmuCell Corporation's shares have significantly declined following the release of its third-quarter 2025 earnings, reflecting investor caution despite operational improvements [1] Sales & Revenue Performance - Product sales for Q3 2025 decreased by 8% year over year to $5.5 million from $6 million, attributed to shipment timing fluctuations and previous supply constraints [2] - The company's gross margin improved to 43% from 26% a year earlier, driven by better production yields and a cumulative price increase of approximately 6% [3] - The quarterly net loss narrowed to $140,000, or 2 cents per share, compared to a loss of $702,000, or 9 cents per share, in the same quarter last year [3] Year-to-Date Performance - For the first nine months of 2025, ImmuCell reported a net income of $1.8 million, a turnaround from a net loss of $2.7 million in the prior year, supported by higher sales and improved margins [4] - Operating income improved to $20,000 in Q3 2025, reversing a $575,000 operating loss from the previous year [5] - Adjusted EBITDA for Q3 reached approximately $751,000, up from $196,000 a year earlier, indicating enhanced operational efficiency [5] Cash and Working Capital - Cash and cash equivalents at the end of Q3 were $3.9 million, slightly up from $3.8 million at the end of 2024, despite inventory investments for peak demand [6] - Working capital expanded to $12.8 million, reflecting a stronger balance sheet [6] Domestic and International Sales - Domestic sales increased by 2% year over year in Q3 and 9.5% from Q2 2025 [7] - International sales, particularly to Canada, declined due to shipment timing, but international revenue for the first nine months of 2025 increased by 15% year over year [7] Management Commentary - Management noted the company has exited a prolonged order backlog, allowing for renewed customer acquisition efforts [8] - The new CEO emphasized a focus on operational excellence, customer engagement, and consistent product availability [8] - Improved manufacturing performance and pricing actions were highlighted as key drivers of margin expansion [9] Factors Influencing Sales - The year-over-year decline in quarterly sales was largely due to the unwinding of backlog dynamics, with distributors restocked earlier in the year [10] - Gross margin improvement was attributed to enhanced production yields, higher sales, and a composite price increase implemented in 2025 [11] Forward-Looking Considerations - The company anticipates continued challenging year-over-year comparisons due to prior backlog fulfillment, with normalization expected by the second half of 2026 [12] - Management is prioritizing operational discipline, customer engagement, and reinvestment in commercial opportunities [12] Product Development - FDA approval for the novel mastitis treatment, Re-Tain, is still pending, with investigational product use ongoing to gather field performance feedback [13] Leadership Transition - A leadership transition is underway as long-serving executive Michael Brigham steps back and Olivier te Boekhorst assumes the role of president and CEO [14] - The company is evaluating investments in production capacity and aseptic filling capabilities, with some capital projects paused due to cash constraints [14]