PORTLAND, Maine, March 18, 2026 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), an animal health biologics company that develops, manufactures and markets products to improve calf health and productivity, today announced that Kathy Turner has been appointed to its Board of Directors, effective April 1, 2026. Ms. Turner replaces Steven Rosgen, who is retiring from the Board after serving since January 2018. Upon joining the Board, Ms. Turner will serve as Chair of the C ...

Core Viewpoint - ImmuCell Corporation reported improved financial performance for the year ended December 31, 2025, with significant operational improvements and a strategic focus on its First Defense product line, despite facing some challenges in the fourth quarter. Financial Performance - For the year 2025, ImmuCell reported product sales of $27.6 million, a 4.3% increase from $26.5 million in 2024 [2] - The net loss narrowed to $1 million, or 12 cents per basic share, from a net loss of $2.2 million, or 26 cents per basic share, in the prior year [2] - Gross margin expanded to 41.4% of product sales in 2025 from 30% in 2024, reflecting operational improvements and stronger sales volumes [2] Operating Metrics - Gross profit reached $11.4 million for the year, up from $7.9 million in 2024, driven by improved production volumes and manufacturing efficiencies [3] - Operating income turned positive with net operating income of $1.6 million in 2025, compared to an operating loss of $1.6 million in the previous year, representing an improvement of $3.3 million [4] Quarterly Performance - In the fourth quarter, product sales were $7.6 million, down 1.6% from $7.75 million in the same quarter last year [5] - Domestic sales increased by 8.7% year over year to approximately $7 million, while international sales declined to about $600,000 due to order timing issues [5] Operating Expenses - Total operating expenses rose to $9.8 million in 2025 from $9.6 million in 2024, primarily due to higher general and administrative costs [6] Balance Sheet - ImmuCell ended the year with $3.8 million in cash and cash equivalents, unchanged from 2024 [7] - Net working capital increased to approximately $13 million from $10.6 million, attributed to higher finished goods inventory levels [7] Management Commentary - Management characterized 2025 as a successful year, emphasizing operational improvements and strategic changes, particularly focusing on the First Defense franchise [8] - The company increased manufacturing output, boosting average monthly production from approximately 345,000 units in 2024 to about 380,000 units in 2025 [9] Market Fundamentals - The calf health market is expanding, with U.S. producers spending approximately $93 million on scours prevention products in 2025, a 14% increase from 2024 [10] - A significant portion of calves still receive no treatment, indicating a large addressable market opportunity [10] Strategic Outlook - The company expects manufacturing improvements to support continued sales growth in 2026 and 2027, with plans to increase production capacity to 5-6 million units annually [14] - ImmuCell is strengthening its commercial operations by adding sales personnel and hiring an international market development leader to accelerate customer outreach [15] Strategic Developments - The company decided to shift focus away from the Re-Tain product program, pausing investment in it to prioritize the First Defense franchise [16] - Certain Re-Tain-related assets were written down and are expected to be repurposed to support First Defense production [17] Overall Assessment - The 2025 results reflect operational progress, improved margins, and a clearer strategic focus, although near-term profitability is influenced by restructuring-related charges and ongoing investments [18]

Financial Data and Key Metrics Changes - Total product sales for 2025 reached $27.6 million, representing a 4.3% increase compared to 2024 [4][8] - Net operating profit improved by $3.3 million to $1.6 million in 2025, driven by expanded gross margins [4][14] - Gross margin for Q4 2025 was 38%, up from 37% in Q4 2024, while the full year gross margin increased to 41% from 30% in 2024 [9][10] - Net loss for 2025 was $1 million, a $1.1 million improvement from 2024, with basic net loss per share improving to approximately $0.12 from $0.26 [13][14] Business Line Data and Key Metrics Changes - Domestic sales in Q4 2025 grew by 8.7% to $7 million, while international sales declined to approximately $600,000 [6][8] - The product mix showed a shift towards Tri-Shield, indicating new customer acquisition and migration from lower-priced products [9] Market Data and Key Metrics Changes - The U.S. market for calf scours prevention products saw a 14% increase in spending to approximately $93 million in 2025 [17][18] - Despite price increases, 55% of calves still do not receive treatment for scours, indicating a significant addressable market of over $200 million in the U.S. alone [18] Company Strategy and Development Direction - The company has pivoted to focus on maximizing shareholder value from the First Defense franchise, pausing investment in the Re-Tain product line [4][19] - Manufacturing capacity has increased from 3 million units in 2023 to 4.6 million units in 2025, with plans to further increase capacity to between 5 million and 6 million units [19][20] - The company is enhancing its sales capacity by hiring new personnel and implementing a standardized sales approach [22][23] Management Comments on Operating Environment and Future Outlook - Management acknowledges challenges in increasing yield and capacity to meet market demand, emphasizing proactive outreach to gain new customers [25][26] - There is confidence in future growth due to improved manufacturing capabilities and a focus on the First Defense product line [19][20] Other Important Information - A non-cash write-down of approximately $650,000 was taken in Q3 and Q4 2025, primarily related to Re-Tain inventory [10][12] - Operating expenses increased to $3 million in Q4 2025, driven by higher general and administrative costs [11] Q&A Session Summary Question: What are the biggest challenges ahead for the company to achieve its goals? - Management identified planned increases in yield and capacity as primary challenges, alongside a shift to proactive customer outreach for growth [25][26] Question: Will there be any additional Re-Tain write-downs in 2026? - Management does not anticipate large write-downs for Re-Tain assets, with a modest salvage value booked [27] Question: How much of 2025 revenue is considered recurring? - Management noted high customer loyalty and satisfaction, but could not provide exact figures on recurring revenue due to previous backorder situations [28][30]

Financial Data and Key Metrics Changes - Total product sales for 2025 reached $27.6 million, representing a 4.3% increase compared to 2024 [4][8] - Net operating profit improved by $3.3 million to $1.6 million in 2025, driven by expanded gross margins [4][14] - Gross margin for Q4 2025 was 38%, up from 37% in Q4 2024, while the full year gross margin increased to 41% from 30% in 2024 [9][10] - Net loss for 2025 was $1 million, a $1.1 million improvement from 2024, with basic net loss per share improving to approximately $0.12 from $0.26 [13][14] Business Line Data and Key Metrics Changes - Domestic sales in Q4 2025 grew by 8.7% to $7 million, while international sales declined to about $600,000, primarily due to order timing [8][9] - The product mix showed a shift towards Tri-Shield, indicating new customer acquisition and migration from lower-priced products [9] Market Data and Key Metrics Changes - The U.S. market for calf scours prevention products saw a 14% increase in spending to approximately $93 million in 2025 [17][18] - Despite the growth, about 55% of calves still do not receive any treatment for scours, indicating a significant addressable market of over $200 million in the U.S. alone [18] Company Strategy and Development Direction - The company has pivoted to focus on maximizing shareholder value from the First Defense franchise, which is positioned in a growing market for calf health solutions [4][5] - Manufacturing capacity has been increased from approximately 3 million units in 2023 to 4.6 million units in 2025, with plans to further expand capacity to between 5 and 6 million units [19][20] - The company has paused investment in a subclinical mastitis product to concentrate on the scours market opportunity and improve manufacturing capabilities [19][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in future growth due to increased manufacturing capacity and a proactive approach to customer acquisition [19][26] - The company aims to address challenges related to yield improvement and capacity expansion while focusing on top-line growth [25][26] Other Important Information - A non-cash write-down of approximately $650,000 was taken in Q3 and Q4 2025, primarily related to inventory [10][12] - Operating expenses increased to $3 million in Q4 2025, driven by higher general and administrative costs [11] Q&A Session Summary Question: What are the biggest challenges ahead for the company to achieve its goals? - Management identified challenges related to planned yield increases and capacity expansion, emphasizing the need for proactive customer outreach [25][26] Question: Will there be any additional Re-Tain write-downs in 2026? - Management does not anticipate large write-downs for Re-Tain assets, with a modest salvage value already booked [27] Question: How much of 2025 revenue is considered recurring? - Management noted high customer loyalty and satisfaction, but could not provide exact churn calculations due to past supply constraints [28][30]

Financial Data and Key Metrics Changes - In 2025, total product sales reached $27.6 million, with a net operating profit of $1.6 million, an improvement of $3.3 million compared to 2024, primarily due to expanded gross margins [4][5] - 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, while international sales declined to about $600,000 [6][8] - Gross margin for Q4 2025 was 38%, up from 37% in Q4 2024, and for the full year, gross margin increased to 41% from 30% in 2024 [9][10] - Operating expenses increased to $3 million in Q4 2025 from $2.2 million in Q4 2024, and for the full year, they rose to $9.8 million from $9.6 million [11] Business Line Data and Key Metrics Changes - The product mix showed a shift towards Tri-Shield, indicating new customer acquisition and migration from lower-priced Dual-Force products [9] - The company experienced a significant increase in gross margins due to higher manufacturing volumes and efficiencies, alongside product price increases [10][21] Market Data and Key Metrics Changes - The U.S. market for calf scours prevention products saw producers spending approximately $93 million in 2025, a 14% increase from 2024 [18][19] - Despite the growth, about 55% of calves still do not receive any treatment for scours, indicating a substantial addressable market exceeding $200 million in the U.S. alone [19] Company Strategy and Development Direction - The company has pivoted to focus on maximizing shareholder value from the First Defense franchise, pausing investment in the Re-Tain product line to concentrate on the scours market opportunity [5][20] - Manufacturing capacity has been increased from approximately 3 million units in 2023 to 4.6 million units in 2025, with plans to further enhance capacity to between 5 and 6 million units [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in future growth due to addressing manufacturing capacity and gaining revenue share against major competitors [20] - The company aims to enhance commercial activities and customer outreach, focusing on growth in the top line for 2026 and 2027 [27] Other Important Information - A non-cash write-down of approximately $650,000 was taken in Q3 and Q4 2025, primarily related to inventory, impacting gross margins [10][12] - The company ended 2025 with $3.8 million in cash and increased working capital from $10.6 million at the end of 2024 to $13 million [14] Q&A Session Summary Question: What are the biggest challenges ahead for the company to achieve its goals? - Management identified challenges related to planned yield increases and capacity expansion, focusing on proactive customer outreach for growth [26][27] Question: Will there be any additional Re-Tain write-downs in 2026? - Management does not anticipate large write-downs for Re-Tain assets, with a modest salvage value booked [28] Question: How much of the 2025 revenue is considered recurring? - Management noted high customer loyalty and satisfaction, indicating a strong potential for recurring revenue, though exact churn calculations are currently difficult [29][31]

Core Viewpoint - ImmuCell Corporation reported a successful year in 2025 with improvements in net operating income and gross margin, despite a net loss due to non-recurring items [2][7]. Financial Performance - The company achieved a net operating income of $1.6 million in 2025, an increase of $3.3 million compared to 2024 [2]. - Revenue for 2025 grew by 4.3% to approximately $27.6 million compared to 2024 [7]. - Gross profit improved to 41.4% of product sales in 2025, up from 30% in 2024 [7]. - The net loss for 2025 was $1.0 million, an improvement of $1.1 million compared to a net loss of $2.2 million in 2024 [2][7]. Operational Highlights - Average monthly output increased from approximately 345,000 units in 2024 to 380,000 units in 2025 [2]. - The company plans to focus on its successful First Defense franchise moving forward [2]. Balance Sheet Data - Cash and cash equivalents remained stable at $3.8 million as of December 31, 2025, unchanged from 2024 [7][10]. - Net working capital increased to approximately $13.0 million as of December 31, 2025, up from $10.6 million in 2024 [7][10]. - Stockholders' equity decreased to $27.1 million as of December 31, 2025, down from $27.5 million in 2024 [7][10]. Cash Flow Data - Operating activities generated $2.475 million in cash in 2025, compared to $357,000 in 2024 [12]. - Investing activities resulted in a cash outflow of $1.214 million in 2025, compared to $461,000 in 2024 [12]. - Financing activities led to a cash outflow of $1.212 million in 2025, contrasting with a cash inflow of $2.883 million in 2024 [12].

Core Viewpoint - ImmuCell Corporation is set to report its unaudited financial results for the quarter and year ended December 31, 2025, on March 4, 2026, with a conference call scheduled for the following morning to discuss these results [1][2][3]. Financial Reporting - The company anticipates no changes to the preliminary sales results disclosed on January 8, 2026, for the quarter and year ended December 31, 2025 [3]. - ImmuCell plans to file its Annual Report on Form 10-K on or before March 31, 2026 [3]. Company Overview - ImmuCell Corporation focuses on developing, manufacturing, and marketing products that enhance cattle health and productivity, including its product First Defense, which provides Immediate Immunity™ to newborn dairy and beef calves [4].

Industry Overview - The medical and health products industry is evolving under regulatory pressures and the need for differentiated, clinically validated solutions, with a focus on niche markets and specialty products [1] - There is a growing emphasis on targeted therapies and specialty products to meet clearly defined patient needs, alongside operational discipline and cash-flow generation amid rising costs and regulatory complexity [2] - Companies expect performance to be influenced by their ability to execute within niche markets, maintain regulatory compliance, and convert prior investments into incremental revenues and margin improvement [3] Cumberland Pharmaceuticals (CPIX) - Cumberland Pharmaceuticals operates as a specialty pharmaceutical company focused on branded prescription products in hospital acute care, gastroenterology, and oncology markets, with a portfolio of FDA-approved products [5] - For the first nine months of 2025, CPIX generated $30.8 million in net revenues, representing year-over-year growth, and produced a positive operating cash flow of $4.9 million [6] - CPIX is expanding its commercial portfolio with the addition of Talicia, an FDA-approved treatment for H. pylori infection, and is advancing international expansion initiatives and Phase II clinical programs for ifetroban [7][8] Natural Alternatives International (NAII) - NAII operates in nutritional supplement manufacturing and ingredient commercialization, serving as a leading private-label contract manufacturer for vitamins and supplements [9] - For fiscal 2025, NAII reported net sales of $129.9 million, primarily from private-label contract manufacturing, with a strong operational foundation supported by advanced manufacturing facilities and certifications [10] - NAII's growth priorities include expanding customer relationships, broadening branded ingredient adoption, and pursuing complementary acquisitions, with a focus on high-quality nutritional supplements [11][12] ImmuCell Corporation (ICCC) - ImmuCell focuses on improving the health and productivity of dairy and beef cattle, with its core product, First Defense, providing immediate immunity to newborn calves [13] - In the first nine months of 2025, ImmuCell reported $20 million in product sales and a net income of $1.8 million, attributed to higher production output and improved gross margin [14] - The company is expanding production capacity to support an annualized revenue run rate approaching $30 million and is focused on the regulatory progress of Re-Tain, a treatment for mastitis [15][16] Conclusion - CPIX, NAII, and ICCC demonstrate how focused strategies and regulatory alignment can support growth in highly regulated healthcare markets, leveraging specialization and disciplined operations [17][18]

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]