Financial Data and Key Metrics Changes - The company reported a significant increase in order backlog, which more than doubled since the end of 2022 due to a slowdown in production output in the first quarter of 2023 [5][12] - Sales are expected to be reduced in the first quarter of 2023, with a large backlog reported as of March 31, 2023 [5][11] - The company has deferred completion of incremental investments to increase production capacity beyond $30 million per year due to loss in gross margin during the first quarter [5][12] Business Line Data and Key Metrics Changes - The production capacity for the First Defense product line is currently at $30 million per year, with plans to increase it to over $40 million in the future [4][13] - The contamination issues have impacted production output, but corrective actions are being implemented to ensure future production meets quality standards [12][13] Market Data and Key Metrics Changes - Demand for the First Defense product has been strong, but the contamination issues have led to challenges in fulfilling orders [12][68] - The company is facing competition as some customers may seek alternative products during the backlog period, which could lead to loss of market share [68] Company Strategy and Development Direction - The company aims to resolve contamination issues and ramp up production capacity to meet the strong demand for First Defense [12][13] - The strategic focus for 2024 is to be more commercially oriented, emphasizing sales of First Defense and the controlled launch of the Re-Tain product [23][32] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by contamination events but expressed confidence in the company's ability to recover and grow production capacity [11][12] - The company is preparing for a significant FDA product development initiative, with expectations for a submission in the first quarter of 2023 [32][50] Other Important Information - The company plans to file its full audited financial results on Form 10-K around March 29, 2023, which will provide more details on the impact of contamination and remediation efforts [30][66] - The company has made a conscious decision to increase selling expenses to support sales recovery efforts [52] Q&A Session Summary Question: Were any batches salvaged from the contamination event? - Management indicated that some product could be salvaged and reworked, while others would be written off, with evaluations ongoing [15] Question: What methods will be used to raise deferred funds? - Management stated that options include loans, selling stock, or other methods, with a focus on maintaining gross margin as the primary funding source [17][18] Question: Will the Re-Tain product be manufactured in the same facility as First Defense? - Management clarified that the Re-Tain facility operates under different standards and has no crossover with the First Defense production facility [39] Question: What is the expected timeline for the FDA submission for Re-Tain? - Management confirmed that the submission is expected to occur in March 2023, with a six-month review period following [50] Question: Why has the SG&A line increased significantly? - Management explained that the increase is due to higher selling expenses related to new personnel and sales programs aimed at recovering from the backlog [51][52]

ImmuCell Corporation (NASDAQ:ICCC) Q3 2022 Earnings Conference Call November 22, 2022 9:00 AM ET Company Participants Joe Diaz - Lytham Partners, IR Michael Brigham - President and CEO Bobbi Jo Brockmann - Vice President, Sales and Marketing Conference Call Participants Jim Barrett - Barrett Investments Operator Good morning. And welcome to ImmuCell Corporation Reports Third Quarter Fiscal Year 2022 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] Af ...

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, 2022 001-12934 (Commission file number) | Delaware | 01-0382980 | | --- | --- | | (State of Incorporation) | (I.R.S. Employer | | | Identification No.) | | 56 Evergreen Drive, Portland, ME | 04103 | | (Address of principal executive office) | (Zip Code) | ImmuCell Corporation (Exact name of reg ...

| --- | --- | --- | --- | |----------------------------------------------------------|-------|-------|-------| | | | | | | ImmuCell Corporation Investor Presentation August 2022 | | | | | | | | | Forward-Looking Statements Cautionary Note Regarding Forward-Looking Statements (Safe Harbor Statement): This presentation contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are no ...

ImmuCell Corporation (NASDAQ:ICCC) Q2 2022 Earnings Conference Call August 12, 2022 9:00 AM ET Company Participants Joe Diaz - Investor Relations Michael Brigham - President and Chief Executive Officer Conference Call Participants George Melas - MKH Management Operator Good morning. This is Anthony from Chorus Call and I will be assisting with our conference call this morning. To get things started, let me ask Joe Diaz to open up the call. Joe Diaz Good morning and welcome to all. As the operator indicated, ...

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, 2022 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 ...

ImmuCell Corporation (NASDAQ:ICCC) Q1 2022 Earnings Conference Call May 13, 2022 9:00 AM ET Company Participants Joe Diaz - Lytham Partners, IR Michael Brigham - President and CEO Joseph Crabb - Former Chief Scientific Officer and VP Operator Good morning. This is Andrea from Chorus Call. I will be assisting with your conference call this morning. To get things started, let me ask Joe Diaz to open up the call. Joe Diaz Thank you, Andrea. Good morning, and welcome to everyone on the call this morning. My nam ...

[PART I: FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%3A%20FINANCIAL%20INFORMATION) This section provides ImmuCell Corporation's unaudited financial statements and management's discussion and analysis for the period ended March 31, 2022, along with market risk disclosures and controls [ITEM 1. Unaudited Financial Statements](index=3&type=section&id=ITEM%201.%20Unaudited%20Financial%20Statements) This section presents ImmuCell Corporation's unaudited financial statements for the period ended March 31, 2022, including the Balance Sheets, Statements of Operations, Statements of Stockholders' Equity, and Statements of Cash Flows, along with comprehensive notes detailing business operations, significant accounting policies, and specific financial account breakdowns [Balance Sheets](index=3&type=section&id=BALANCE%20SHEETS) This section provides a comparative overview of the company's financial position through its Balance Sheets as of March 31, 2022, and December 31, 2021 Balance Sheet Highlights (March 31, 2022 vs. December 31, 2021) | Metric | March 31, 2022 (USD) | December 31, 2021 (USD) | Change (Absolute, USD) | Change (%) | | :-------------------------------- | :------------- | :---------------- | :---------------- | :--------- | | Total Current Assets | $18,299,101 | $16,264,868 | $2,034,233 | 12.5% | | Total Assets | $46,699,496 | $44,465,688 | $2,233,808 | 5.0% | | Total Current Liabilities | $2,351,100 | $2,534,469 | ($183,369) | -7.2% | | Total Liabilities | $13,326,957 | $11,888,748 | $1,438,209 | 12.1% | | Total Stockholders' Equity | $33,372,539 | $32,576,940 | $795,599 | 2.4% | [Statements of Operations](index=4&type=section&id=STATEMENTS%20OF%20OPERATIONS) This section presents the company's financial performance for the three-month periods ended March 31, 2022, and 2021, through its Statements of Operations Statements of Operations Highlights (Three-Month Periods Ended March 31) | Metric | 2022 (USD) | 2021 (USD) | Change (Absolute, USD) | Change (%) | | :-------------------------- | :------------ | :------------ | :---------------- | :--------- | | Product sales | $5,999,684 | $4,107,146 | $1,892,538 | 46.1% | | Costs of goods sold | $2,896,461 | $2,504,958 | $391,503 | 15.6% | | Gross margin | $3,103,223 | $1,602,188 | $1,501,035 | 93.7% | | Operating expenses | $2,310,235 | $1,976,813 | $333,422 | 16.9% | | Net Operating Income (Loss) | $792,988 | ($374,625) | $1,167,613 | N/A | | Net Income (Loss) | $735,666 | ($441,303) | $1,176,969 | N/A | | Basic EPS | $0.10 | ($0.06) | $0.16 | N/A | | Diluted EPS | $0.09 | ($0.06) | $0.15 | N/A | [Statements of Stockholders' Equity](index=5&type=section&id=STATEMENTS%20OF%20STOCKHOLDERS'%20EQUITY) This section details the changes in the company's stockholders' equity for the three-month period ended March 31, 2022 Stockholders' Equity Changes (Three-Month Period Ended March 31, 2022) | Item | Amount (USD) | | :---------------------- | :------------- | | Balance, Dec 31, 2021 | $32,576,940 | | Net income | $735,666 | | Exercise of stock options | $5,840 | | Stock-based compensation | $54,093 | | Balance, Mar 31, 2022 | $33,372,539 | [Statements of Cash Flows](index=6&type=section&id=STATEMENTS%20OF%20CASH%20FLOWS) This section outlines the cash inflows and outflows from operating, investing, and financing activities for the three-month periods ended March 31 Cash Flow Highlights (Three-Month Periods Ended March 31) | Cash Flow Activity | 2022 (USD) | 2021 (USD) | Change (Absolute, USD) | | :------------------------- | :------------ | :------------ | :---------------- | | Operating Activities | $638,535 | ($623,546) | $1,262,081 | | Investing Activities | ($796,496) | $656,684 | ($1,453,180) | | Financing Activities | $1,789,629 | ($176,425) | $1,966,054 | | Net Increase (Decrease) | $1,631,668 | ($143,287) | $1,774,955 | | Ending Cash & Equivalents | $11,817,136 | $6,806,650 | $5,010,486 | [Notes to Unaudited Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the unaudited financial statements, covering accounting policies, specific account balances, and other financial information [1. Business Operations](index=8&type=section&id=1.%20BUSINESS%20OPERATIONS) This note describes ImmuCell Corporation's core business as an animal health company focused on dairy and beef cattle, highlighting its key product segments and operational challenges - ImmuCell Corporation is an animal health company focused on dairy and beef cattle, with two main business segments: First Defense (prevention of scours in newborn calves) and Re-Tain (treatment for subclinical mastitis in lactating dairy cows)[20](index=20&type=chunk) - The company is experiencing price increases and shortages in key components, services, and transportation due to the global COVID-19 pandemic, which may cause production slowdowns[21](index=21&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the critical accounting principles and methods used in preparing the financial statements, including revenue recognition, inventory, and fair value measurements - The company follows GAAP, with significant policies covering cash equivalents, trade accounts receivable, inventory valuation (lower of cost or net realizable value, FIFO method), depreciation of property/plant/equipment, amortization of intangible assets, and annual impairment assessment for goodwill and indefinite-lived intangibles[22](index=22&type=chunk)[23](index=23&type=chunk)[24](index=24&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk)[28](index=28&type=chunk) - Fair value measurements are categorized into a three-level hierarchy, with cash and money market accounts classified as Level 1 assets[31](index=31&type=chunk)[33](index=33&type=chunk) - Revenue is recognized when control of products is transferred to customers, typically upon delivery, with an immaterial amount of product returns historically[37](index=37&type=chunk) - Stock-based compensation expense is recognized using the fair-value-based method, estimated with the Black-Scholes option pricing model[43](index=43&type=chunk) - The company maintains a full valuation allowance against its net deferred tax assets due to historical net losses, but this could be reduced if future profitability is realized[39](index=39&type=chunk)[40](index=40&type=chunk) [3. Cash, Cash Equivalents and Short-Term Investments](index=15&type=section&id=3.%20CASH%2C%20CASH%20EQUIVALENTS%20AND%20SHORT-TERM%20INVESTMENTS) This note provides a breakdown of the company's cash, cash equivalents, and short-term investments as of the reporting dates Cash and Cash Equivalents (As of March 31, 2022 vs. December 31, 2021) | Item | March 31, 2022 (USD) | December 31, 2021 (USD) | | :------------------------ | :------------- | :---------------- | | Cash and cash equivalents | $11,817,136 | $10,185,468 | | Short-term investments | — | — | | Total | $11,817,136 | $10,185,468 | [4. Trade Accounts Receivable, net](index=15&type=section&id=4.%20TRADE%20ACCOUNTS%20RECEIVABLE%2C%20net) This note details the company's trade accounts receivable, net of any allowance for bad debt, as of the reporting dates Trade Accounts Receivable, net (As of March 31, 2022 vs. December 31, 2021) | Item | March 31, 2022 (USD) | December 31, 2021 (USD) | | :-------------------------- | :------------- | :---------------- | | Trade accounts receivable, net | $2,652,591 | $2,694,229 | | Allowance for bad debt | $0 | $0 | [5. Inventory](index=15&type=section&id=5.%20INVENTORY) This note provides a detailed breakdown of the company's inventory by raw materials, work-in-process, and finished goods Inventory Breakdown (As of March 31, 2022 vs. December 31, 2021) | Item | March 31, 2022 (USD) | December 31, 2021 (USD) | | :-------------- | :------------- | :---------------- | | Raw materials | $1,732,628 | $971,606 | | Work-in-process | $1,597,888 | $1,902,299 | | Finished goods | $105,318 | $216,069 | | Total | $3,435,834 | $3,089,974 | [6. Prepaid Expenses and Other Current Assets](index=15&type=section&id=6.%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) This note presents the composition of prepaid expenses and other current assets as of the reporting dates Prepaid Expenses and Other Current Assets (As of March 31, 2022 vs. December 31, 2021) | Item | March 31, 2022 (USD) | December 31, 2021 (USD) | | :--------------- | :------------- | :---------------- | | Prepaid expenses | $387,393 | $268,713 | | Other receivables | $6,147 | $26,484 | | Total | $393,540 | $295,197 | [7. Property, Plant and Equipment, net](index=16&type=section&id=7.%20PROPERTY%2C%20PLANT%20AND%20EQUIPMENT%2C%20net) This note details the company's property, plant, and equipment, net of accumulated depreciation, including ongoing construction projects Property, Plant and Equipment, net (As of March 31, 2022 vs. December 31, 2021) | Item | March 31, 2022 (USD) | December 31, 2021 (USD) | | :--------------------------------- | :------------- | :---------------- | | Laboratory and manufacturing equipment | $17,790,623 | $17,388,757 | | Buildings and improvements | $19,315,965 | $19,119,698 | | Construction in progress | $3,187,950 | $2,992,359 | | Property, plant and equipment, net | $27,132,148 | $26,893,599 | - Construction in progress primarily relates to the First Defense production capacity expansion and equipment for in-house Re-Tain formulation and aseptic filling[56](index=56&type=chunk) - Depreciation expense for the three-month period ended March 31, 2022, was **$616,847**, a slight increase from **$614,695** in the prior year period[56](index=56&type=chunk) [8. Intangible Assets](index=16&type=section&id=8.%20INTANGIBLE%20ASSETS) This note provides information on the company's intangible assets, including developed technology, customer relationships, and non-compete agreements Intangible Assets, net (As of March 31, 2022 vs. December 31, 2021) | Item | March 31, 2022 (USD) | December 31, 2021 (USD) | | :-------------------- | :------------- | :---------------- | | Developed technology | $69,037 | $73,640 | | Customer relationships | $488 | $520 | | Non-compete agreements | $2,115 | $2,256 | | Total | $71,640 | $76,416 | - Intangible assets are amortized over 10 years, with an estimated annual amortization expense of **$19,104** through December 31, 2025[57](index=57&type=chunk) [9. Accounts Payable and Accrued Expenses](index=16&type=section&id=9.%20ACCOUNTS%20PAYABLE%20AND%20ACCRUED%20EXPENSES) This note details the company's accounts payable and accrued expenses, categorized by type, as of the reporting dates Accounts Payable and Accrued Expenses (As of March 31, 2022 vs. December 31, 2021) | Item | March 31, 2022 (USD) | December 31, 2021 (USD) | | :---------------------------- | :------------- | :---------------- | | Accounts payable – trade | $595,904 | $726,781 | | Accounts payable – capital | $66,163 | $18,263 | | Accrued payroll | $322,033 | $585,939 | | Accrued professional fees | $59,325 | $82,050 | | Accrued other | $250,344 | $199,076 | | Accrued income tax payable | — | $2,141 | | Total | $1,293,769 | $1,614,250 | [10. Bank Debt](index=18&type=section&id=10.%20BANK%20DEBT) This note describes the company's bank debt arrangements, including mortgage notes, lines of credit, and associated covenants - The company refinanced debt with Gorham Savings Bank (GSB) in Q1 2020, including a **$5.1 million** mortgage note (Loan 6) and a **$3.5 million** note (Loan 7), both at **3.50%** fixed interest, plus a **$1 million** line of credit[62](index=62&type=chunk) - In Q1 2022, an additional **$2 million** in mortgage debt was secured, increasing Loan 6 to **$6,233,957** at a blended fixed rate of **3.53%** per annum, with a balloon payment due in Q1 2032[62](index=62&type=chunk) - The required minimum Debt Service Coverage (DSC) ratio was reduced to **1.0** for the year ending December 31, 2022, from **1.35**[62](index=62&type=chunk) Debt Principal Repayments (Three-Month Periods Ended March 31) | Loan | 2022 Repayments (USD) | 2021 Repayments (USD) | | :----- | :-------------- | :-------------- | | Loan 6 | ($30,183) | ($28,922) | | Loan 7 | ($118,033) | ($113,991) | | Loan 10 | ($49,169) | ($47,464) | | Total | ($197,385) | ($190,377) | [11. Contingent Liabilities and Commitments](index=19&type=section&id=11.%20CONTINGENT%20LIABILITIES%20AND%20COMMITMENTS) This note outlines the company's contingent liabilities, indemnification obligations, and significant capital and inventory commitments - The company indemnifies its officers and directors to the maximum extent permitted by Delaware law and maintains D&O liability insurance; no liability has been recorded for these obligations[68](index=68&type=chunk)[69](index=69&type=chunk) - Commitments as of March 31, 2022, include **$940,000** for First Defense production capacity expansion, **$406,000** for Re-Tain Drug Product formulation/filling facility, **$2,461,000** for inventory, and other capital expenditures[75](index=75&type=chunk) - An amended Deferred Compensation Agreement with President and CEO Mr. Brigham allows for up to an additional **$300,000** in deferred compensation, vesting annually from January 2023 to January 2025[74](index=74&type=chunk) [12. Operating Lease](index=21&type=section&id=12.%20OPERATING%20LEASE) This note details the company's operating lease arrangements for office and warehouse space, including right-of-use assets and lease liabilities - The company leases **14,300 sq ft** of office and warehouse space for **10 years**, with a right-of-use asset of **$1,078,051** and a lease liability of **$1,108,166** as of March 31, 2022[76](index=76&type=chunk) Operating Lease Costs (Three-Month Periods Ended March 31) | Lease Cost Item | 2022 (USD) | 2021 (USD) | | :---------------- | :---------- | :---------- | | Operating lease cost | $29,991 | $29,499 | | Variable lease cost | $10,350 | $10,350 | | Total lease cost | $40,341 | $39,849 | [13. Stockholders' Equity](index=22&type=section&id=13.%20STOCKHOLDERS'%20EQUITY) This note provides information on the company's common stock, stock option plans, stock-based compensation, and the Common Stock Rights Plan - From 2016 to 2021, the company raised approximately **$26.7 million** in gross proceeds from six common equity transactions[80](index=80&type=chunk) - As of March 31, 2022, there were **217,500** options outstanding under the 2010 Stock Option Plan and **279,500** under the 2017 Stock Option Plan[91](index=91&type=chunk)[92](index=92&type=chunk) - Total unrecognized stock-based compensation related to non-vested stock options aggregated **$533,895** as of March 31, 2022, to be recognized over approximately **1 year and 11 months**[99](index=99&type=chunk) - The Common Stock Rights Plan, with an ownership threshold of **20%** for 'Acquiring Person' status, is set to expire on September 19, 2022, with an advisory vote for a one-year extension planned for June 2022[101](index=101&type=chunk)[104](index=104&type=chunk) [14. Revenue](index=29&type=section&id=14.%20REVENUE) This note disaggregates the company's product sales by geographic area and major product category for the reported periods - The First Defense product line, primarily sold in North America through distributors, accounted for **99%** of total sales in Q1 2022[108](index=108&type=chunk)[109](index=109&type=chunk) Product Sales Disaggregated by Geographic Area (Three-Month Periods Ended March 31) | Geographic Area | 2022 Sales (USD) | 2022 % | 2021 Sales (USD) | 2021 % | | :---------------- | :----------- | :----- | :----------- | :----- | | United States | $5,515,749 | 92% | $3,580,516 | 87% | | Other | $483,935 | 8% | $526,630 | 13% | | Total Product Sales | $5,999,684 | 100% | $4,107,146 | 100% | Product Sales Disaggregated by Major Product Category (Three-Month Periods Ended March 31) | Product Category | 2022 Sales (USD) | 2022 % | 2021 Sales (USD) | 2021 % | | :------------------ | :----------- | :----- | :----------- | :----- | | First Defense product line | $5,962,875 | 99% | $4,023,471 | 98% | | Other animal health | $36,809 | 1% | $83,675 | 2% | | Total Product Sales | $5,999,684 | 100% | $4,107,146 | 100% | [15. Other Expenses, Net](index=29&type=section&id=15.%20OTHER%20EXPENSES%2C%20NET) This note details the components of other expenses, net, including interest expense, gains on asset disposal, and interest income Other Expenses, Net (Three-Month Periods Ended March 31) | Item | 2022 (USD) | 2021 (USD) | | :------------------------ | :-------- | :-------- | | Interest expense | $75,214 | $79,635 | | Gain on disposal of fixed assets | ($11,000) | ($10,000) | | Interest income | ($7,188) | ($2,957) | | Income - other | ($852) | — | | Other expenses (income), net | $56,174 | $66,678 | [16. Income Taxes](index=29&type=section&id=16.%20INCOME%20TAXES) This note provides information on the company's income tax expense, net operating loss carryforwards, and valuation allowance - Income tax expense was **$1,148** in Q1 2022, compared to **$0** in Q1 2021, representing **0.2%** of income before taxes[111](index=111&type=chunk) - As of December 31, 2021, the company had federal net operating loss carryforwards of **$14.7 million** and federal general business tax credit carryforwards of **$557,795**, largely offset by a full valuation allowance[111](index=111&type=chunk)[114](index=114&type=chunk) [17. Segment Information](index=31&type=section&id=17.%20SEGMENT%20INFORMATION) This note presents financial information disaggregated by the company's two reportable segments: First Defense and Re-Tain - The company operates in two reportable segments: First Defense (USDA-regulated, preventing scours in calves) and Re-Tain (FDA-regulated, treating subclinical mastitis in dairy cows)[117](index=117&type=chunk) Segment Net Operating Income (Loss) (Three-Month Periods Ended March 31) | Segment | 2022 Net Operating Income (Loss, USD) | 2021 Net Operating Income (Loss, USD) | | :------------ | :------------------------------- | :------------------------------- | | First Defense | $2,683,463 | $1,132,641 | | Re-Tain | ($1,374,962) | ($1,057,468) | | Other | ($515,513) | ($449,798) | | Total | $792,988 | ($374,625) | Segment Capital Expenditures (Three-Month Periods Ended March 31) | Segment | 2022 Capital Expenditures (USD) | 2021 Capital Expenditures (USD) | | :------------ | :------------------------ | :------------------------ | | First Defense | $740,467 | $349,316 | | Re-Tain | $67,029 | — | | Total | $807,496 | $349,316 | [18. Related Party Transactions](index=33&type=section&id=18.%20RELATED%20PARTY%20TRANSACTIONS) This note discloses transactions with related parties, specifically product sales to affiliated companies of a board member - Affiliated companies of Dr. David S. Tomsche (Chair of the Board) purchased **$226,833** of products in Q1 2022, up from **$112,301** in Q1 2021, on terms consistent with other distributors[123](index=123&type=chunk) [19. Employee Benefits](index=33&type=section&id=19.%20EMPLOYEE%20BENEFITS) This note details the company's contributions to its 401(k) savings plan for employee benefits - The company contributed **$41,864** to its 401(k) savings plan in Q1 2022, matching **100%** of the first **3%** and **50%** of the next **2%** of employee contributions[124](index=124&type=chunk) [20. Subsequent Events](index=33&type=section&id=20.%20SUBSEQUENT%20EVENTS) This note confirms that no material subsequent events occurred between the reporting period end and the filing date - No material, reportable subsequent events occurred through the filing date of May 12, 2022[125](index=125&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, liquidity, and results of operations for the three-month period ended March 31, 2022, highlighting key financial changes, operational strategies, and the impact of external factors like the COVID-19 pandemic and inflation [Cautionary Note Regarding Forward-Looking Statements (Safe Harbor Statement)](index=34&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements%20(Safe%20Harbor%20Statement)) This section advises readers that the report contains forward-looking statements subject to various risks and uncertainties - The report contains forward-looking statements subject to risks and uncertainties, including those related to regulatory approvals, market demand, COVID-19, supply-chain disruptions, inflation, and product development[129](index=129&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) This section analyzes the company's cash flows, capital expenditures, debt obligations, and ability to meet future financial requirements - Net cash provided by operating activities increased by **$1.3 million** to **$639,000** in Q1 2022, primarily due to a **$1.2 million** increase in net income[131](index=131&type=chunk) - Cash used for investing activities was **($796,000)** in Q1 2022, mainly for capital expenditures related to manufacturing facility expansion[131](index=131&type=chunk) - Cash provided by financing activities increased to **$1.8 million** in Q1 2022, largely due to a **$2 million** loan amendment[131](index=131&type=chunk) - The company anticipates debt principal repayments of approximately **$907,000** and interest expense of **$337,000** during the twelve-month period ending March 31, 2023[133](index=133&type=chunk) - The company believes current cash and anticipated gross margin will be sufficient to meet working capital and capital expenditure requirements for at least **12 months**[136](index=136&type=chunk) Selected Key Accounts (March 31, 2022 vs. December 31, 2021) | Account | March 31, 2022 (in thousands USD) | December 31, 2021 (in thousands USD) | Increase (in thousands USD) | % Change | | :---------------------- | :---------------------------- | :------------------------------- | :---------------------- | :------- | | Cash and cash equivalents | $11,817 | $10,185 | $1,632 | 16% | | Net working capital | $15,948 | $13,730 | $2,218 | 16% | | Total assets | $46,699 | $44,466 | $2,234 | 5% | | Stockholders' equity | $33,373 | $32,577 | $796 | 2% | | Common shares outstanding | 7,743 | 7,742 | 1 | 0% | - The company has allocated approximately **$5.4 million** of its cash on hand as of March 31, 2022, to complete ongoing capital projects (PROJECT D to G) and routine capital expenditures, leaving **$6.4 million** for general working capital[146](index=146&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) This section discusses the company's financial performance, including product sales, gross margin, and various expense categories, for the reported periods [Business Segments](index=39&type=section&id=Business%20Segments_MD%26A) This section reiterates the company's operational structure across its First Defense and Re-Tain business segments - The company operates in two segments: First Defense (USDA-regulated, preventing scours in calves) and Re-Tain (FDA-regulated, treating subclinical mastitis in dairy cows)[149](index=149&type=chunk) [Product Sales](index=39&type=section&id=Product%20Sales) This section analyzes the growth in product sales, particularly for the First Defense line, and discusses factors influencing sales performance - Total product sales increased by **46%** to **$6 million** in Q1 2022 compared to Q1 2021, driven by increased demand for the First Defense product line[152](index=152&type=chunk) - Sales of the First Defense product line constituted **99%** of total sales in Q1 2022, with a deliberate strategy to prioritize Tri-Shield production[151](index=151&type=chunk) Product Sales (Three-Month Periods Ended March 31) | Metric | 2022 (USD) | 2021 (USD) | Increase (Amount, USD) | Increase (%) | | :---------------- | :---------- | :---------- | :---------------- | :----------- | | Total product sales | $6,000,000 | $4,107,000 | $1,893,000 | 46% | - The company's annualized manufacturing output for First Defense reached **$23.8 million** in Q1 2022, exceeding the **$23 million** target[156](index=156&type=chunk) - The backlog of orders was approximately **$1.6 million** as of May 6, 2022, down from **$2.4 million** as of December 31, 2021, but supply chain disruptions and increased raw material costs remain challenges[158](index=158&type=chunk) - Selling prices for the First Defense product line increased by approximately **5%** effective January 1, 2022[162](index=162&type=chunk) [Impact of Global COVID-19 Pandemic and Russia's Unprovoked Military Invasion of Ukraine](index=43&type=section&id=Impact%20of%20Global%20COVID-19%20Pandemic%20and%20Russia's%20Unprovoked%20Military%20Invasion%20of%20Ukraine) This section addresses the adverse effects of global events on the company's production, supply chain, and input costs - The company faces significant production constraints, supply disruptions, and inflationary increases due to COVID-19 and the Russia-Ukraine war, impacting input costs like feed for customers[164](index=164&type=chunk) [Gross Margin](index=43&type=section&id=Gross%20Margin) This section examines the significant improvement in gross margin and the factors contributing to its percentage increase Gross Margin (Three-Month Periods Ended March 31) | Metric | 2022 (USD) | 2021 (USD) | Increase (Amount, USD) | Increase (%) | | :---------------------- | :---------- | :---------- | :---------------- | :----------- | | Gross margin | $3,103,000 | $1,602,000 | $1,501,000 | 94% | | Percent of product sales | 52% | 39% | 13% | 33% | - Gross margin as a percentage of product sales improved significantly to **52%** in Q1 2022, up from **39%** in Q1 2021, due to spreading fixed costs over increasing production output[167](index=167&type=chunk) - The company aims for an annual gross margin in the range of **46% to 50%** as increased capacity is fully integrated and utilized, despite rising costs of supplies and labor[167](index=167&type=chunk) [Product Development Expenses](index=44&type=section&id=Product%20Development%20Expenses) This section details expenditures on product development, primarily for Re-Tain, and its regulatory progress and facility investments - Product development expenses remained stable at just over **$1 million** in Q1 2022, representing **17%** of product sales, down from **25%** in Q1 2021[168](index=168&type=chunk) - The majority of development spending is focused on Re-Tain, a Nisin A treatment for subclinical mastitis, aiming to provide an antibiotic alternative with zero milk discard and meat withhold periods[169](index=169&type=chunk) - Four of the five required FDA Technical Sections for Re-Tain (Environmental Impact, Target Animal Safety, Effectiveness, Human Food Safety) have received Complete Letters[172](index=172&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk) - The final Chemistry, Manufacturing and Controls (CMC) Technical Section was resubmitted in Q1 2022, with potential market launch in Q4 2022 if approved after a six-month FDA review[176](index=176&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk) - The company is investing approximately **$4 million** to bring Re-Tain Drug Product formulation and aseptic filling in-house, anticipating FDA approval of this facility by Q4 2023 or Q2 2024[181](index=181&type=chunk) [Sales and Marketing](index=50&type=section&id=Sales%20and%20Marketing) This section discusses the increase in sales and marketing expenses, particularly in preparation for the Re-Tain product launch - Sales and marketing expenses increased by **56%** to **$812,000** in Q1 2022, representing **14%** of product sales, with expectations to rise to **20%** of sales in 2022 for Re-Tain market launch and in-person events[185](index=185&type=chunk) - Re-Tain is expected to revolutionize mastitis treatment by allowing early treatment of subclinical cases without milk discard, offering a significant competitive advantage and animal welfare benefit[186](index=186&type=chunk) - The company plans a controlled launch for Re-Tain, focusing on early adopters and direct sales support to ensure successful implementation and long-term market acceptance, rather than a mass market approach[189](index=189&type=chunk) - Initial sales projections for Re-Tain under the controlled launch plan are approximately **$1 million** in 2023 and double that in 2024, assuming FDA approval and Q4 2022 launch[192](index=192&type=chunk) [Administrative Expenses](index=53&type=section&id=Administrative%20Expenses) This section reviews the changes in administrative expenses, including non-cash items like depreciation and stock-based compensation - Administrative expenses increased by **9%** to **$463,000** in Q1 2022, including non-cash depreciation and stock-based compensation[194](index=194&type=chunk) [Net Operating Income (Loss)](index=53&type=section&id=Net%20Operating%20Income%20(Loss)) This section highlights the significant improvement in net operating income, driven by increased sales and gross margin - Net operating income was **$793,000** in Q1 2022, a significant improvement from a net operating loss of **($375,000)** in Q1 2021, primarily due to increased product sales and gross margin[195](index=195&type=chunk) [Other Expenses, net](index=53&type=section&id=Other%20Expenses%2C%20net_MD%26A) This section details the components and changes in other expenses, net, including interest expense - Other expenses, net, decreased to **$56,000** in Q1 2022 from **$67,000** in Q1 2021, with interest expense slightly decreasing to **$75,000**[196](index=196&type=chunk) [Income (Loss) Before Income Taxes](index=53&type=section&id=Income%20(Loss)%20Before%20Income%20Taxes) This section reports the company's income before income taxes, reflecting a turnaround from a prior-year loss - Income before income taxes was **$737,000** in Q1 2022, a turnaround from a **($441,000)** loss in Q1 2021[197](index=197&type=chunk) [Income Taxes and Net Income (Loss)](index=53&type=section&id=Income%20Taxes%20and%20Net%20Income%20(Loss)) This section presents the company's net income and diluted EPS, noting the impact of net operating loss carryforwards on income tax expense - Net income was **$736,000** (**$0.09** diluted EPS) in Q1 2022, compared to a net loss of **($441,000)** (**$-0.06** basic EPS) in Q1 2021, with minimal income tax expense due to net operating loss carryforwards[198](index=198&type=chunk) [Critical Accounting Policies](index=55&type=section&id=Critical%20Accounting%20Policies) This section identifies the accounting policies requiring significant management judgment and estimates, such as revenue recognition and inventory valuation - Key critical accounting policies include revenue recognition (ASC 606, at shipment), and inventory valuation (lower of cost or net realizable value, FIFO method), which is critical due to management estimates and biological yield variability[204](index=204&type=chunk)[205](index=205&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures about Market Risk](index=55&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section discusses the company's exposure to market risks, including inflation, interest rates, and currency exchange rates, and their potential impact on revenues, expenses, and debt obligations - Inflation, interest rates, and currency exchange rates are having an adverse effect on revenues and expenses, with future increases potentially impacting customer demand[206](index=206&type=chunk) - The company's bank debt of approximately **$10 million** as of March 31, 2022, bears a blended fixed interest rate of **3.52%** per annum, mitigating direct interest rate exposure[206](index=206&type=chunk) - Two subordinated loans from the State of Maine totaling **$900,000** will bear a fixed interest rate of **5%** per annum once interest-free periods expire in Q4 2022 and Q3 2023[206](index=206&type=chunk) [ITEM 4. Controls and Procedures](index=55&type=section&id=ITEM%204.%20Controls%20and%20Procedures) This section details the effectiveness of the company's disclosure controls and procedures and internal control over financial reporting as of March 31, 2022, confirming their effectiveness and reporting no material changes - Management concluded that disclosure controls and procedures were effective as of March 31, 2022[207](index=207&type=chunk) - Internal control over financial reporting was assessed as effective as of March 31, 2022, based on the COSO framework[208](index=208&type=chunk)[209](index=209&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2022[210](index=210&type=chunk) [PART II: OTHER INFORMATION](index=57&type=section&id=PART%20II%3A%20OTHER%20INFORMATION) This section covers additional information including legal proceedings, risk factors, equity sales, defaults, mine safety, other disclosures, and exhibits [ITEM 1. Legal Proceedings](index=57&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not currently aware of any pending or threatened legal proceedings that would have a material adverse effect on its business, results of operations, or financial condition - No pending or threatened legal proceedings are expected to have a material adverse effect on the company's business or financial condition[213](index=213&type=chunk) [ITEM 1A. Risk Factors](index=57&type=section&id=ITEM%201A.%20Risk%20Factors) This section outlines various risks that could materially affect the company's business, financial condition, and results of operations, including financial, product, regulatory, economic, company-specific, global, and common stock-related risks [Financial Risks](index=57&type=section&id=Financial%20Risks) This section details financial risks including challenges in achieving gross margin goals, increased debt service costs, and inflation impacts - There is a risk that the company may not achieve its gross margin goals (approaching **50%**) due to cost increases, inability to raise selling prices, or both, impacting operating results[214](index=214&type=chunk) - Increased debt service costs (approximately **$1.2 million** in 2022 and **$1.24 million** in 2023) could impair the company's ability to fund operations if sales or gross margin decline[215](index=215&type=chunk) - The company may not satisfy the minimum debt service coverage (DSC) ratio of **1.0** for 2022, despite a negotiated reduction from **1.35**[216](index=216&type=chunk) - Inflation is materially and adversely impacting supply and labor costs, posing a risk to gross margin[217](index=217&type=chunk) - The realizability of net deferred tax assets is uncertain, contingent on future profitability, and a full valuation allowance is currently in place[222](index=222&type=chunk) [Product Risks](index=58&type=section&id=Product%20Risks) This section outlines risks related to product development, regulatory compliance, market acceptance, and reliance on specific product lines and distributors - Risks include production, financial, efficacy, regulatory, and competitive challenges, with elevated standards for regulatory compliance and potential for increased costs due to variable biological yields[223](index=223&type=chunk) - Market acceptance of Re-Tain is uncertain due to the need to change current dairy practices and potential issues with milk inhibitor tests or cheese making if Nisin concentrations are too high[224](index=224&type=chunk)[226](index=226&type=chunk)[227](index=227&type=chunk) - Unsatisfactory Re-Tain treatment outcomes could occur if users lack SCC monitoring equipment, administer the product to unsuitable cows, or use it off-label for clinical mastitis[228](index=228&type=chunk)[229](index=229&type=chunk)[230](index=230&type=chunk) - The company is highly reliant on First Defense product line sales (**99%** of total sales in Q1 2022) and faces risks from sales concentration to two large distributors (**75%** of sales in Q1 2022)[231](index=231&type=chunk)[232](index=232&type=chunk) - Production capacity constraints and order backlogs for First Defense pose a risk of losing customers, despite ongoing investments to increase annual capacity to **$35 million** by end of 2022[233](index=233&type=chunk) [Regulatory Risks](index=61&type=section&id=Regulatory%20Risks) This section addresses risks associated with USDA and FDA approvals, including potential delays or failures in obtaining necessary product and facility clearances - First Defense is subject to USDA inspection, with a risk of unfavorable outcomes or the need for additional clinical studies if Reference Standard requalification is not approved[237](index=237&type=chunk) - Re-Tain requires FDA approval, with risks of delays or failure to obtain necessary approvals for the product and facilities, especially for the complex Chemistry, Manufacturing and Controls (CMC) section[238](index=238&type=chunk) [Economic Risks Pertaining to the Dairy and Beef Industries](index=61&type=section&id=Economic%20Risks%20Pertaining%20to%20the%20Dairy%20and%20Beef%20Industries) This section discusses economic factors in the dairy and beef industries, such as herd size, milk price volatility, and their impact on product sales - The U.S. cattle and dairy herd sizes have shown recent declines, impacting the overall market for animal health products[240](index=240&type=chunk)[241](index=241&type=chunk) - Milk prices have been highly volatile, with the Class III milk price averaging **$17.08** in 2021 (down **6%** YoY) but increasing to **$22.04** in the first four months of 2022 (up **29%**)[242](index=242&type=chunk) - The milk-to-feed price ratio, a key profitability indicator, averaged **1.76** in 2021 (down **24%** YoY) but improved to **2.10** in Q1 2022 (up **19%**)[245](index=245&type=chunk) - Volatile market conditions and financial insecurities in the dairy and beef industries pose risks to maintaining and growing sales of premium-priced products[246](index=246&type=chunk) [Small Size of Company](index=63&type=section&id=Small%20Size%20of%20Company) This section highlights risks stemming from the company's small size, including reliance on key personnel, external parties, and intense competition - As a small company with **67 employees**, reliance on key personnel and limited redundancy poses a risk if key employees are lost, especially in the current difficult labor market[247](index=247&type=chunk) - Dependence on outside parties like Norbrook for Re-Tain Drug Product services, and the transition to in-house manufacturing, carries risks of supply interruption, cost overruns, and regulatory approval delays[248](index=248&type=chunk) - The company faces competition from significantly larger and more diversified companies with greater resources in both First Defense and mastitis treatment markets[250](index=250&type=chunk) [Global Risks](index=64&type=section&id=Global%20Risks) This section addresses global risks such as geopolitical conflicts, the ongoing pandemic, and bovine disease epidemics, and their economic impacts - Russia's invasion of Ukraine is negatively impacting the global economy, increasing oil prices, transportation expenses, and grain costs, which affects customer profitability[251](index=251&type=chunk) - The COVID-19 pandemic continues to create uncertainty, supply-chain disruptions, and inflationary pressures, affecting colostrum supply, product demand, and international market penetration[252](index=252&type=chunk) - Epidemics of bovine diseases (e.g., Foot and Mouth Disease, BSE) present a risk to the company and its customers, potentially leading to tighter regulations on animal-origin ingredients[253](index=253&type=chunk) [Risks Pertaining to Common Stock](index=64&type=section&id=Risks%20Pertaining%20to%20Common%20Stock) This section discusses risks related to the company's common stock, including trading volume, anti-takeover provisions, and dividend policy - The company's common stock has lower average daily trading volume, larger bid/ask spreads, and higher volatility compared to larger companies, potentially making it difficult for investors to sell shares[254](index=254&type=chunk) - Provisions in the company's certificate of incorporation, bylaws, and Common Stock Rights Plan, along with Delaware law, could discourage or delay changes in control or management[257](index=257&type=chunk) - The company does not anticipate paying dividends or repurchasing stock in the foreseeable future, intending to use cash for product development, facility investments, working capital, and debt reduction[259](index=259&type=chunk) - Future issuances of common stock to fund growth objectives could have a dilutive effect on existing stockholders[260](index=260&type=chunk) [Other Risks](index=66&type=section&id=Other%20Risks) This section covers additional risks such as reliance on single-source suppliers, intellectual property protection, and cybersecurity vulnerabilities - Reliance on single sources for critical raw materials (e.g., colostrum antibodies, syringes) and contract manufacturing services (e.g., Norbrook for Re-Tain DP) poses risks of supply disruption and increased expenses[261](index=261&type=chunk) - Failure to protect intellectual property through patents or trade secrets, or challenges from competitors, could adversely affect the company's ability to commercialize products[263](index=263&type=chunk) - Increasing dependence on IT systems makes the company susceptible to cyberattacks, which could lead to production downtimes, data loss, reputational damage, and financial impact[264](index=264&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=67&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section indicates that there were no unregistered sales of equity securities or related use of proceeds to report during the period [ITEM 3. Defaults Upon Senior Securities](index=67&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities to report during the period [ITEM 4. Mine Safety Disclosures](index=67&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This section indicates that there were no mine safety disclosures to report during the period [ITEM 5. Other Information](index=67&type=section&id=ITEM%205.%20Other%20Information) This section states that there was no other information to report during the period [ITEM 6. Exhibits](index=68&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including certifications and XBRL-related documents - Exhibits include Certifications required by Rule 13a-14(a) (Exhibit 31), Certification pursuant to Section 1350 (Exhibit 32), and various Inline XBRL documents (101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104)[267](index=267&type=chunk) [Signature](index=69&type=section&id=Signature) The report was duly signed on behalf of ImmuCell Corporation by Michael F. Brigham, President, Chief Executive Officer, and Principal Financial Officer, on May 12, 2022 - The Quarterly Report on Form 10-Q was signed by Michael F. Brigham, President, Chief Executive Officer, and Principal Financial Officer, on May 12, 2022[269](index=269&type=chunk)

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 For the fiscal year ended December 31, 2021 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, Maine | 04103 | | (Address of principal exec ...

ImmuCell Corp (NASDAQ:ICCC) Q4 2021 Earnings Conference Call February 23, 2022 9:00 AM ET Company Participants Michael Brigham – President, Chief Executive Officer Joe Diaz – Lytham Partner Betsy Williams – Vice President of Manufacturing Operations Bobbi Jo Brockmann – Vice President of Sales & Marketing Conference Call Participants George Melas – MKH Managements Tom Fox – Private Investor Operator Good morning and welcome to ImmuCell Corporation's fourth quarter fiscal year 2021 financial results. My name ...