The broader medical and health products industry continues to evolve under the dual pressures of regulatory oversight and the need for differentiated, clinically validated solutions. Across pharmaceuticals, nutritional supplements and animal health, companies are increasingly focusing on niche markets, specialty products and science-backed innovation rather than broad commoditized offerings.Recent industry trends underscore a growing emphasis on targeted therapies and specialty products for clearly defined ...

PresentationJoe DiazLytham Partners, LLC Thank you, Jamie. Good morning, and welcome. As our operator indicated, my name is Joe Diaz with Lytham Partners. We're the Investor Relations consulting firm for ImmuCell. I thank all of you for joining us today to discuss the change in ImmuCell's strategic focus and the unaudited sales results for the fourth quarter and full year December 31, 2025. Listeners are reminded and caution that statements made by management during the course of this call include forward-l ...

Core Insights - ImmuCell estimates the worldwide total addressable market for scour protection at approximately $900 million [1] - The company is shifting its strategy to focus on the First Defense calf-health franchise while pausing investment in Re-Tain due to an FDA "Incomplete Letter" [6][5] Market Dynamics - Management highlighted that the economics of newborn calves have changed significantly, with calf values rising from about $200 in 2003 to approximately $1,300 today, leading to increased demand for scour protection [2] - Calf sales have grown from 2%-3% to 20%-25% of annual dairy income for some operations [2] Strategic Shift - ImmuCell plans to complete ongoing investigational studies for Re-Tain by 2026 and will focus on expanding First Defense capacity instead [3] - The decision to pause investment in Re-Tain is based on confidence in First Defense's growth potential and the implications of the FDA's Incomplete Letter [5] Financial Performance - Unaudited product sales for Q4 2025 were reported at $7.6 million, a decrease of 1.6% from Q4 2024, with domestic sales growing 8.7% year-over-year [8][9] - Total product sales for the full year 2025 increased by 4.3% to $27.6 million, with a noted shift towards the Tri-Shield product within the First Defense suite [10] Manufacturing and Compliance Issues - ImmuCell has passed FDA requirements for safety and efficacy for Re-Tain, but issues with the contract manufacturer responsible for aseptic filling have delayed approval [12][13] - The company plans to repurpose most manufacturing assets from Re-Tain for First Defense, although certain equipment will not be useful [16] Future Plans and Investments - The company is expanding its sales team by 50% and creating two new U.S. territories to enhance commercial expansion [19] - Management anticipates a non-cash impairment write-down of approximately $2.9 million related to Re-Tain, along with an estimated inventory write-down of about $600,000 [17][18] - Additional capital may be needed for future investments, including a potential $3 million capital outlay for a new freeze dryer [20]

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]

Sales Performance - Total sales for Q4 2025 were $7.6 million, a 1.6% decline from Q4 2024 sales of $7.8 million[4] - Total sales for the full year 2025 were $27.6 million, a 4.3% increase compared to 2024 sales of $26.5 million[4] - Domestic sales in 2025 were $24.4 million, a 6.5% increase from 2024[6] - International sales in 2025 were $3.3 million, a 9.6% decline compared to 2024[6] - Tri-Shield® sales reached $19.9 million in 2025, a 26.5% increase from 2024[6] - Dual-Force® and other sales were $7.7 million in 2025, a 28.2% decline compared to 2024[6] Financial Adjustments - The company plans to record a $2.9 million non-cash impairment write-down related to Re-Tain® during Q4 2025[4] Operational Improvements - Manufacturing improvements increased output of the lyophilization process by over 15% year-over-year in 2025[5] Strategic Initiatives - The company is expanding its sales force by 50% by creating two new domestic territories and hiring an international business development executive[8] - The company intends to focus on commercial expansion and scalable manufacturing capacity to support growth in the First Defense® product line[8]

Core Viewpoint - ImmuCell Corporation reported preliminary, unaudited sales results for Q4 and full year 2025, indicating a mixed performance with a slight decline in quarterly sales but an overall increase in annual sales [1][3]. Sales Performance - Total sales for Q4 2025 were $7.6 million, a 1.6% decline from $7.8 million in Q4 2024 [3]. - Total sales for the full year 2025 reached $27.6 million, representing a 4.3% increase compared to $26.5 million in 2024 [3]. - Domestic sales for Q4 2025 were $7.0 million, an 8.7% increase from $6.4 million in Q4 2024 [5]. - International sales for Q4 2025 were $0.6 million, a significant decline of 52.6% from $1.3 million in Q4 2024 [5]. Product Line Performance - Tri-Shield sales for Q4 2025 were $6.0 million, a 41.3% increase from $4.2 million in Q4 2024 [5]. - Dual-Force and other sales for Q4 2025 were $1.7 million, a 53.0% decline from $3.6 million in Q4 2024 [5]. - For the full year 2025, Tri-Shield sales totaled $19.9 million, a 26.5% increase from $15.8 million in 2024 [5]. - Dual-Force sales for the full year 2025 were $6.9 million, a 27.4% decline from $9.6 million in 2024 [5]. Strategic Focus - The company announced a strategic shift to focus on expanding the First Defense product line after receiving an FDA Incomplete Letter for the Re-Tain product [3][6]. - ImmuCell plans to repurpose assets related to Re-Tain, valued at approximately $15.5 million, to enhance the First Defense product line [3][4]. - Manufacturing improvements have increased output of the lyophilization process by over 15% year-over-year in 2025, with plans for similar enhancements in 2026 [4]. Financial Write-Downs - The company expects to record a non-cash impairment write-down of approximately $2.9 million related to Re-Tain during Q4 2025 [3][4]. - Additional write-downs include $0.1 million for other property, plant, and equipment, and $0.6 million for inventory deemed unfit for processing [4].

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].