PORTLAND, Maine, April 08, 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 preliminary, unaudited sales results for the first quarter of 2025. Since the first quarter of 2020, the Company has been providing a preliminary look at its unaudited top line results soon aft ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) April 08, 2025 ImmuCell Corporation | (Exact name of registrant as specified in its charter) | | | | --- | --- | --- | | DE | 001-12934 | 01-0382980 | | (State or other jurisdiction | (Commission File Number) | (IRS Employer Identification No.) | | of incorporation) | | | | 56 Evergreen Drive Po ...

PORTLAND, Maine, April 08, 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 preliminary, unaudited sales results for the first quarter of 2025. Since the first quarter of 2020, the Company has been providing a preliminary look at its unaudited top line results soon aft ...

Core Viewpoint - ImmuCell Corporation has appointed Timothy C. Fiori as Chief Financial Officer, bringing significant experience to the company during a crucial phase of its development [1][2][3]. Company Overview - ImmuCell Corporation focuses on developing, manufacturing, and marketing products that enhance the health and productivity of dairy and beef cattle [4]. - The company offers First Defense®, which provides Immediate Immunity™ to newborn calves, and is nearing the completion of Re-Tain®, a treatment for subclinical mastitis in dairy cows that avoids traditional antibiotic restrictions [4]. Leadership Changes - Timothy C. Fiori has approximately 24 years of finance and commercial operating experience from IDEXX Laboratories [2]. - Fiori expressed enthusiasm about joining ImmuCell and contributing to the company's growth, highlighting the potential of its product portfolio [3]. - Michael F. Brigham, President and CEO, emphasized that Fiori's experience will be instrumental in improving financial systems and operational efficiencies [3].

Core Viewpoint - ImmuCell Corporation is initiating Investigational Product use of Re-Tain to test market acceptance while awaiting full regulatory approval [1][4] Company Developments - The controlled launch of Re-Tain aims to utilize existing inventory before its shelf-life expiration, although it is not expected to generate significant revenue or profit [2] - The company submitted its Non-Administrative New Animal Drug Application (NADA) in early January 2025, which included the fourth submission of the CMC Technical Section [3] - The critical path for NADA approval is clearing inspectional observations at the facilities of the company's contract manufacturer [3] Product Information - Re-Tain is a novel treatment for subclinical mastitis in dairy cows, designed to avoid FDA-required milk discard or pre-slaughter withdrawal label restrictions, providing an alternative to traditional antibiotics [6]

Financial Performance - Total assets increased by 209%, from $14.6 million in 2015 to $45.1 million in 2024, while stockholders' equity rose by 159%, from $10.6 million to $27.5 million during the same period[17]. - The company aims to exceed total product sales of $26.5 million achieved during the year ended December 31, 2024, as soon as possible, with a longer-term goal of exceeding $35 million by approximately 2027[46]. - Net cash provided by operating activities improved by $5 million, reaching $358,000 in 2024 compared to a net cash used of ($4.7 million) in 2023[154]. - Cash and cash equivalents increased by 284%, from $979,000 in 2023 to $3.76 million in 2024[158]. - Net working capital rose by 46%, from $7.27 million in 2023 to $10.63 million in 2024[158]. - Aggregate debt outstanding decreased from $12 million in 2023 to $10.5 million in 2024[156]. - Financing activities generated $2.9 million in 2024, up from $1.8 million in 2023, including $3 million in new debt proceeds received in Q3 2023[156]. - The company anticipates interest expenses of $452,000 in 2025 and $322,000 in 2026, down from $526,000 in 2024[156]. - The company has a total of 15 million common shares authorized, with 8,982,623 shares outstanding as of March 21, 2025[147]. - The company does not currently pay dividends and has no plans to do so in the near future[147]. Product Development and Market Strategy - The Re-Tain product, aimed at treating subclinical mastitis, has received FDA approval for four out of five significant Technical Sections, with the final submission made in January 2025[15]. - The company aims to fulfill existing order backlogs and expand its market share in both beef and dairy sectors while launching a lower-cost spray-dried product[22]. - The company is working to expand its product development pipeline of antimicrobials as alternatives to traditional antibiotics through expansions of its Nisin technology[53]. - The company is developing a spray-dried alternative format of First Defense Technology to potentially expand its product portfolio and improve cash flow[200]. - The anticipated product label for Re-Tain includes claims for treating subclinical mastitis associated with specific pathogens in lactating dairy cattle[210]. Sales and Market Share - The market share of the First Defense product line in the dairy and beef market (calculated on the basis of calves treated) increased from 36% in 2019 to 48% in 2023, with a projected stabilization at 48% in 2024[34]. - The total U.S. market for scours preventative products for newborn calves is estimated at approximately $31.1 million per year, with the total domestic addressable market (including dam-level products) estimated at $81.8 million per year[32]. - Domestic sales increased by 35% and international sales surged by 308% in Q4 2024 compared to Q4 2023, with international sales comprising 17% of total sales in Q4 2024[183]. - The Tri-Shield First Defense product line accounted for 55% of total sales in Q4 2024, highlighting its significance in revenue generation[184]. Production and Capacity - The production capacity for the First Defense product line is targeted to exceed $30 million annually, with facility expansions completed by the end of 2022[21]. - The company has increased its production capacity to over $30 million per year, addressing an order backlog of approximately $4.7 million as of March 21, 2025[148]. - The DS production facility is expected to have an initial annual production capacity sufficient to meet approximately $10 million in sales of Re-Tain at current production yields[45]. - Production capacity for the First Defense product line increased from approximately $16.5 million to approximately $30 million, with a total investment of $9.9 million from 2019 to December 31, 2024[96]. Contamination and Quality Control - The company experienced contamination events leading to scrapped inventory, resulting in charges of approximately $407,000 in 2024 and $527,000 in 2023[21]. - The company has experienced production contamination events that began in late 2022 and continued through April 2024, but believes these issues have been remediated[150]. - The company implemented new quality control measures and process improvements to mitigate contamination risks and enhance production yields[172]. - The company has made significant improvements at the source farm level, including enhanced product testing and staff training, to prevent future contamination events[176]. Regulatory and Compliance Risks - Regulatory risks include the need for FDA approval for the Re-Tain product, which has faced delays and could impact future sales[101]. - The company is exposed to regulatory compliance risks through subcontractors, which could affect its ability to produce necessary products[113]. - The FDA's phased review process for Re-Tain has been ongoing since 2004, with the most recent submission of the CMC Technical Section made in January 2025[206]. Debt and Financial Obligations - As of December 31, 2024, the company's outstanding debt totaled $10.6 million, with a blended fixed interest rate of 4.51% per annum, and significant debt service obligations of approximately $2 million and $3.7 million due in 2025 and 2026, respectively[74]. - The debt service coverage (DSC) ratio was below the required minimum of 1.35, with actual ratios of 0.73 and 1.10 for the years ended December 31, 2024 and 2023, respectively[75]. - The company is required to meet certain financial covenants, and failure to do so could result in unfavorable amendments to debt terms[75]. Market Conditions and Risks - Inflation and rising input costs are adversely affecting the company's gross margins, with significant volatility in the dairy market impacting profitability[77]. - The company is exposed to risks from rising interest rates, which could increase future borrowing costs and financial pressure on dairy and beef producers[74]. - Climate change poses risks that could disrupt the company's operations and negatively impact customer demand for its products[118]. - The concentration of sales and accounts receivable with two large distributors poses a risk, with 78% and 79% of trade accounts receivable due from these distributors as of December 31, 2024 and 2023 respectively[95]. Employee and Operational Risks - The company currently employs 75 employees, a decrease from 79 employees a year ago, with 57 engaged in quality and manufacturing operations[68]. - The company has maintained product liability insurance deemed reasonable relative to potential exposure, with no history of claims to date[97]. - The company relies heavily on key personnel, which poses a risk to operations if any are lost[112]. Growth and Future Outlook - The company anticipates growth in the beef market and international sales, particularly in Canada and potential new markets like Mexico, Pakistan, and India[34]. - The company aims to achieve a gross margin of 40% or more on product sales, but realized gross margins were only 30% and 22% for the years ended December 31, 2024 and 2023, respectively[71]. - The company aims to increase gross margin by approximately 3 to 8 percentage points over the 37% reported for the three-month period ended December 31, 2024[194].

Core Viewpoint - ImmuCell Corporation has demonstrated a significant operational turnaround in the fourth quarter of 2024, marked by strong revenue growth and improved profitability, positioning itself for potential growth in 2025 with the upcoming FDA approval of its novel treatment, Re-Tain [18]. Financial Performance - The company reported earnings per diluted share of 6 cents in Q4 2024, a recovery from a loss of 15 cents in the same quarter of the previous year [2]. - Total quarterly product sales reached $7.8 million, a 52% increase from $5.1 million in Q4 2023, with annual product sales rising 52% to $26.5 million from $17.5 million [3]. - Gross margin improved from 25% in Q4 2023 to 37% in Q4 2024, contributing to a net income of $515,000 for the quarter, compared to a net loss of $1.14 million in the prior year [4]. - EBITDA for Q4 2024 was $1.33 million, a significant improvement from a negative $311,000 in Q4 2023, with full-year EBITDA at $1.1 million compared to a negative $2.58 million in 2023 [5]. Operational Developments - The company has maintained uninterrupted production since April 2024, following previous contamination-related setbacks, and has made operational improvements to enhance production efficiency [6]. - Production capacity has scaled to support over $30 million in annual revenues, with expectations for further operational refinements to enhance gross margin beyond 40% [6]. Balance Sheet Strength - Cash and cash equivalents increased to $3.8 million at the end of 2024 from $979,000 a year earlier, with net working capital improving to $10.6 million from $7.3 million [7]. - Stockholders' equity rose to $27.5 million from $25 million in 2023, and the company has no outstanding balance on its $1 million credit line [7]. Management Insights - CEO Michael Brigham expressed confidence in the company's recovery, attributing financial stabilization to strong sales momentum and margin expansion, while acknowledging pressures from production mix and higher costs [8]. - The growth strategy focuses on the First Defense product line, particularly the Tri-Shield variant, which has been a significant growth driver despite its higher production costs [9]. Market Dynamics - Revenue growth in Q4 2024 was driven by the resolution of prior manufacturing challenges and fulfillment of outstanding orders, following a backlog due to contamination issues in 2023 [10]. - Although gross margin improved to 37%, it remains below the historical range of 40-45%, influenced by product mix and industry-wide cost pressures [11][12]. Future Outlook - A key catalyst for the company is the potential FDA approval of Re-Tain, a novel treatment for subclinical mastitis, with an application submitted in early January 2025 [13]. - Re-Tain is positioned as an alternative to traditional antibiotics, with an estimated economic impact of $2 billion annually on dairy operations, which could unlock significant revenue streams for the company [14]. - The company is also exploring options to offset product development costs and optimize the market rollout of Re-Tain, alongside assessing international market opportunities for its First Defense product line [15]. Strategic Investments - ImmuCell has continued its capital investment strategy but at a more measured pace, deferring certain expenditures, including an estimated $5 million investment to expand production capacity beyond the current $30 million annual revenue threshold [16]. - Preliminary steps have been initiated to introduce a bulk feed format for its colostrum-derived antibody product, which could enhance commercial utilization of production capacity [17].

Financial Data and Key Metrics Changes - Sales growth of 52% during both Q4 2024 and the full year of 2024 compared to the same periods in the prior year [8] - Gross margin increased by 125% or $1.6 million to $2.8 million in Q4 2024 compared to Q4 2023, and increased by 105% or $4.1 million to $7.9 million for the year ended December 31, 2024 compared to 2023 [14] - EBITDA of $1.3 million in Q4 2024, contrasting with negative EBITDA of $311,000 in Q4 2023, and $1.1 million for the year ended December 31, 2024 compared to negative EBITDA of $2.6 million in 2023, marking a swing of approximately $3.7 million [16] Business Line Data and Key Metrics Changes - The company achieved $7.8 million in sales during Q4 2024, indicating successful capacity increase to $30 million or more per year [10] - The gross margin percentage recorded in Q4 2024 was 36.5%, with a target to exceed 40% in the future [15] Market Data and Key Metrics Changes - The company is focused on the dairy market, particularly with the upcoming product Re-Tain, which aims to revolutionize treatment for subclinical mastitis [18] - The initiation of the control launch for Re-Tain is pending FDA clearance, with discussions ongoing for expedited review [19] Company Strategy and Development Direction - The company is committed to seeing Re-Tain through regulatory approval and is exploring strategic options to offset product development expenses [20] - Focus remains on improving operational efficiency and production yields to enhance cash flow and profitability [13] Management's Comments on Operating Environment and Future Outlook - Management noted that production contamination events previously limited growth, but improvements have been made to control quality and increase production capacity [8][10] - The company is optimistic about achieving FDA approval for Re-Tain and is preparing for a market launch in 2025 [19][20] Other Important Information - The company raised net proceeds of almost $4.4 million during 2024 to improve cash position, increasing cash to approximately $3.8 million as of December 31, 2024 [17] - A Form 10-K is planned to be filed around the end of March with audited financial details [22] Q&A Session Summary Question: Inquiry on gross margin and its changes - Management acknowledged that product mix, pricing, and throughput are key factors affecting gross margin, with a goal to return to over 40% [28][31] Question: Clarification on inventory levels and WIP - Management confirmed that increased inventory is primarily due to contracted milk deliveries that could not be utilized due to unforeseen events, but they are exploring new product formats to leverage this inventory [40][42][44] Question: Timeline for new product format - Management indicated that the new product format is expected to be ready for beta testing with customers in 2025, allowing for faster market entry without regulatory hurdles [46][47]

PORTLAND, Maine, Feb. 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 its unaudited financial results for the quarter and year ended December 31, 2024. Product Sales Highlights: Fourth quarter of 2024 product sales increased 52% to approximately $7.8 million compa ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) January 9, 2025 ImmuCell Corporation | (Exact name of registrant as specified in its charter) | | | | --- | --- | --- | | DE | 001-12934 | 01-0382980 | | (State or other jurisdiction | (Commission File Number) | (IRS Employer | | of incorporation) | | Identification No.) | | 56 Evergreen Drive P ...