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, 2020 001-12934 (Commission file number) ImmuCell Corporation (Exact name of registrant as specified in its charter) | Delaware | 01-0382980 | | --- | --- | | (State of Incorporation) | (I.R.S. Employer | | | Identification No.) | | 56 Evergreen Drive, Portland, ME | 04103 | | (Address of principal ...

Financial Performance - ImmuCell Corporation's cash, cash equivalents, and investments increased by 34% from $6.524 million in 2015 to $8.774 million in 2019[17]. - Net working capital rose by 52%, from $7.056 million in 2015 to $10.694 million in 2019[17]. - Total assets surged by 165%, increasing from $14.601 million in 2015 to $38.692 million in 2019[17]. - Stockholders' equity grew by 173%, from $10.614 million in 2015 to $28.991 million in 2019[17]. - Product sales for fiscal 2019 reached $13.723 million, a 25% increase from $10.986 million in fiscal 2018[130]. - Gross margin for fiscal 2019 was $6.740 million, compared to $5.194 million in fiscal 2018, reflecting a 29.8% increase[130]. - Net loss for fiscal 2019 was $1.296 million, an improvement from a net loss of $2.322 million in fiscal 2018[130]. - Basic net loss per share for fiscal 2019 was $0.19, compared to a loss of $0.42 per share in fiscal 2018[130]. - The net operating loss was reduced to $954,000 in 2019 compared to $1,447,000 in 2018, with non-cash expenses exceeding the net operating loss[179]. - The net loss for the year ended December 31, 2019, was $1.3 million, or $0.19 per share, compared to a net loss of $2.3 million, or $0.42 per share, for the year ended December 31, 2018, indicating an improvement in financial performance[185]. Product Development and Sales - Cumulative sales of the First Defense product line exceeded 24 million doses since its inception in 1991[20]. - The new product Tri-Shield First Defense achieved USDA approval in Q4 2017 and combines antibodies against E. coli, coronavirus, and rotavirus[23]. - The First Defense product line is the only USDA-licensed, orally delivered scours preventive product on the market for calves[20]. - The company has achieved FDA approval for four out of five significant regulatory submissions required for the Re-Tain™ product[14]. - The company aims to increase annual product sales from nearly $14 million to approximately $20 million, with a long-term goal of exceeding $30 million within five years after the launch of Re-Tain™[44]. - Sales of the First Defense product line accounted for 97% of total product sales in both 2019 and 2018, with 89% and 87% of sales coming from U.S. dairy and beef industries respectively[76]. - Sales of the First Defense product line rose by 24% in 2019, accounting for 97% of total product sales, with growth primarily driven by Tri-Shield First Defense[153]. - The company's market share of scour preventative products administered at the calf-level increased to approximately 36% in 2019, up from 34% in 2018[154]. Market Conditions and Economic Impact - Market conditions in the dairy and beef industries have weakened since 2014, with milk prices declining by 10% in 2018 compared to 2017[28]. - The U.S. dairy industry incurs approximately $2 billion in economic harm annually due to mastitis, making it the most costly disease affecting the industry[36]. - Subclinical mastitis is estimated to affect 20-30% of the U.S. dairy herd, with a potential market for the new product estimated at $5.8 million in the first year and growing to $36.1 million by the fifth year post-launch[41]. - The average Class III milk price increased by 16% to $16.96 in 2019, following a decline to $14.61 in 2018, which could positively impact customer profitability[87]. - The milk-to-feed price ratio increased by 9% to 2.24 in 2019, indicating improved conditions for dairy farmers compared to the previous year[89]. Regulatory and Compliance - The FDA's Veterinary Feed Directive, effective January 1, 2017, restricts the use of medically important antibiotics, creating a favorable environment for the introduction of Re-Tain™[40]. - The company has received USDA and Canadian Food Inspection Agency approval for various product formats, ensuring compliance with regulatory requirements[67]. - The FDA's phased submission process for Re-Tain™ is ongoing, with the second phased submission anticipated before the end of 2020[168]. - Regulatory compliance risks are heightened as the company relies on subcontractors for the production of Re-Tain™, which must also meet specific regulatory requirements[85]. Investments and Financial Obligations - ImmuCell Corporation raised approximately $12.24 million from common stock sales in 2017 and 2016, and $8.3 million in Q1 2019[16]. - The production facility for Re-Tain™ was constructed at a cost of approximately $20.8 million, with initial capacity projected to meet around $10 million in sales[41]. - The company has invested approximately $17.3 million in the development of Re-Tain™ over a twenty-year period, excluding facility costs[45]. - The company plans to invest approximately $4 million to construct and equip its own Drug Product formulation and aseptic filling capability for Re-Tain™[72]. - The company is obligated to make principal and interest payments totaling approximately $871,000 over the first twelve months of its new debt obligations[97]. - The company has a lease liability of approximately $1.3 million over the initial ten-year term for new office and warehouse space to expand production capacity[121]. - As of December 31, 2019, the company had outstanding debt totaling approximately $5.9 million, with $2.6 million under two mortgages hedged by interest rate swap agreements[190]. Operational Challenges and Risks - The concentration of sales and accounts receivable with two large distributors poses a risk, as they accounted for 69% and 76% of product sales and trade accounts receivable respectively in 2019[76]. - The company faces challenges in estimating the market size and future sales growth potential for both the First Defense product line and Re-Tain™, due to various uncertainties[93]. - The company has increased the number of farms supplying colostrum for its First Defense product line, but risks losing these sources could impact inventory production[99]. - The company has a small workforce of 54 employees, relying on key personnel for multiple operational functions, which poses a risk if any key employee departs[100]. - The company’s product sales are heavily influenced by the economic conditions of the dairy market, which is currently under extreme pressure[105]. Future Outlook - The company expects the FDA to grant a five-year market exclusivity for its product Re-Tain™[53]. - The company plans to expand the number of countries for First Defense product line export approvals, aiming to hold product registrations directly rather than relying on distribution partners[34]. - The company expects to complete in-house investment for drug product formulation and aseptic filling services during 2022, subject to FDA inspection[99]. - The company anticipates implementing annual price increases in line with current inflation rates moving forward[156]. - The company aims to invest less than 20% of product sales in sales and marketing expenses annually, with expectations for this ratio to decrease as sales grow[174]. - The company aims to increase future sales of products outside the United States, which may be influenced by currency fluctuations affecting international pricing[190].

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 September 30, 2019 (207) 878-2770 (Registrant's telephone number) Securities registered pursuant to Section 12(b) of the Exchange Act: None Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the pre ...

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 June 30, 2019 001-12934 (Commission file number) ImmuCell Corporation (Exact name of registrant as specified in its charter) | Delaware | 01-0382980 | | --- | --- | | (State of Incorporation) | (I.R.S. Employer | | | Identification No.) | | 56 Evergreen Drive, Portland, ME | 04103 | | (Address of principal e ...

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 (Registrant's telephone number) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filin ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ImmuCell Corporation Securities registered pursuant to Section 12(b) of the Act: None (Exact name of Registrant as specified in its charter) | Delaware | 01-0382980 | | --- | --- | | (State of incorporation) | (I.R.S. Employer | | | Identification No.) | | 56 Evergreen Drive, Portland, Maine | 04103 | | (Address of principal executive office) ...