ImmuCell Corp (NASDAQ:ICCC) Q3 2021 Earnings Conference Call November 16, 2021 9:00 AM ET Company Participants Joe Diaz - Lytham Partner Michael Brigham - President, CEO, Principal Financial Officer, Treasurer, Secretary & Director Conference Call Participants Scott Billeadeau - Walrus Partners Operator Good morning. This is Betsy 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, Betsy. Good morni ...

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, 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, ME | 04103 | | (Address of princi ...

ImmuCell Corporation (NASDAQ:ICCC) Q2 2021 Earnings Conference Call August 13, 2021 9:00 AM ET Company Participants Joe Diaz - Managing Partner at Lytham Partners, LLC Michael Brigham - President and Chief Executive Officer Conference Call Participants Sam Rebotsky - SER Asset Management Operator Good day, and welcome to the ImmuCell Corporation reports Second Quarter 2021 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today’s presentation, t ...

| --- | --- | --- | --- | |----------------------------------------------------------|-------|-------|-------| | | | | | | ImmuCell Corporation Investor Presentation August 2021 | | | | | | | | | 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 ...

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, 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, ME | 04103 | | (Address of principal e ...

Company Overview and Strategic Focus - ImmuCell aims to capitalize on the growth of First Defense® product line and revolutionize subclinical mastitis treatment with Re-Tain™[5] - The company focuses on delivering Immediate Immunity™ to newborn calves, improving herd productivity without unnecessary dam vaccine injections[5] - ImmuCell is addressing the $2 billion annual economic harm caused by mastitis infections without traditional antibiotics, using Re-Tain™[5] Product Lines and Market Opportunities - First Defense® targets the U S market with approximately $23 4 million in annual sales for calf-level scours prevention products[12] - The company estimates the U S market for dam-level vaccine products to prevent scours is almost 2X the calf-level product sales[13] - Re-Tain™ targets the mastitis market, estimated to cause approximately $2 billion in economic loss to the dairy industry each year[14, 25] Financial Performance and Capital Expenditures - As of March 31, 2021, ImmuCell had $6 8 million in cash and cash equivalents and $9 7 million in net working capital[42] - The company completed an investment of approximately $3 5 million to increase First Defense® production capacity from approximately $16 5 million to approximately $23 million[13, 23] - ImmuCell is constructing a $21 million pharmaceutical production facility for Re-Tain™[14, 24] Sales Growth and Market Share - Total product sales have grown with a 13% CAGR from 2011-2020, reaching $15 3 million in 2020[35] - The company's calf-level U S market share has increased from 34% in 2017 to 41% in 2020[19]

[PART I: FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%3A%20FINANCIAL%20INFORMATION) [Unaudited Financial Statements](index=3&type=section&id=ITEM%201.%20Unaudited%20Financial%20Statements) ImmuCell Corporation reported a decrease in total assets to **$39.6 million** and an increased net loss to **($0.44 million)** in Q1 2021, driven by a **16% drop in product sales** and a negative shift in operating cash flow Balance Sheets Balance Sheet Summary (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Total Current Assets** | $11,810 | $12,157 | | **Total Assets** | **$39,621** | **$40,350** | | **Total Current Liabilities** | $2,098 | $2,211 | | **Total Liabilities** | $11,750 | $12,083 | | **Total Stockholders' Equity** | **$27,871** | **$28,266** | - Total assets decreased slightly from **$40.3 million** at year-end 2020 to **$39.6 million** as of March 31, 2021, primarily due to a decrease in cash and short-term investments[8](index=8&type=chunk) Statements of Operations Statements of Operations Summary (Q1 2021 vs Q1 2020, in USD) | Metric | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Product Sales | $4,107,146 | $4,910,388 | | Gross Margin | $1,602,188 | $2,236,103 | | Net Operating (Loss) Income | ($374,625) | $196,877 | | **Net Loss** | **($441,303)** | **($122,267)** | | **Diluted Net Loss Per Share** | **($0.06)** | **($0.02)** | - Product sales decreased by **16%** year-over-year, leading to a **28%** decline in gross margin, with the company swinging from a net operating income of **$0.20 million** in Q1 2020 to a net operating loss of **($0.38 million)** in Q1 2021[10](index=10&type=chunk) Statements of Cash Flows Cash Flow Summary (Q1 2021 vs Q1 2020, in USD) | Activity | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Net cash (used for) provided by operating activities | ($623,546) | $857,453 | | Net cash provided by investing activities | $656,684 | $713,453 | | Net cash (used for) provided by financing activities | ($176,425) | $41,133 | | **Net (Decrease) Increase in Cash** | **($143,287)** | **$1,612,039** | - Cash from operating activities saw a significant negative swing, primarily due to the net loss, an increase in trade accounts receivable, and changes in inventory[19](index=19&type=chunk) Notes to Unaudited Financial Statements The notes detail the company's animal health business, First Defense, and Re-Tain™ development, highlighting customer concentration, debt structure, and capital commitments for capacity expansion - The company's primary business is creating products to improve the health of dairy and beef cattle, with the First Defense product line being its main revenue source, and it is in the late stages of developing Re-Tain™, a treatment for subclinical mastitis[24](index=24&type=chunk) - The company faces significant customer concentration risk, with Company A accounting for **45%** of sales and Company B for **33%** in Q1 2021, and these two customers representing **48%** and **31%** of total trade accounts receivable as of March 31, 2021[42](index=42&type=chunk)[43](index=43&type=chunk) - As of March 31, 2021, the company had significant commitments, including **$0.18 million** for First Defense capacity expansion, **$0.76 million** for the Re-Tain™ filling facility, and **$1.10 million** for inventory purchases[85](index=85&type=chunk) Revenue by Geography (Q1 2021 vs Q1 2020, in USD) | Region | Q1 2021 Sales | % of Total | Q1 2020 Sales | % of Total | | :--- | :--- | :--- | :--- | :--- | | United States | $3,580,516 | 87% | $4,357,682 | 89% | | Other | $526,630 | 13% | $552,706 | 11% | | **Total** | **$4,107,146** | **100%** | **$4,910,388** | **100%** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the **16% decrease in Q1 2021 product sales** to capacity constraints, leading to a **$3.1 million order backlog** and a gross margin decline to **39%**, while securing a debt covenant waiver after a **$4 million equity raise** - Q1 2021 product sales decreased **16%** to **$4.1 million**, primarily due to production capacity limitations, leading to an order backlog of approximately **$3.1 million** as of March 31, 2021[154](index=154&type=chunk) - Gross margin as a percentage of sales declined to **39%** in Q1 2021 from **46%** in Q1 2020, attributed to increased costs, a more expensive product mix, and upfront costs related to a production capacity expansion not yet fully online[165](index=165&type=chunk) - The company is undertaking seven major capital projects to expand production, including increasing First Defense annual capacity from **$16.5 million** to **$23 million** (Project C) and eventually to **$30 million** (Project G), and a **$4 million** investment to bring Re-Tain™ drug product formulation and filling in-house (Project D)[142](index=142&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk)[149](index=149&type=chunk) - The company does not expect to meet its **1.35** debt service coverage ratio covenant for 2021 due to high product development expenses for Re-Tain™, but its bank (GSB) agreed to waive this requirement following a successful equity raise of over **$4 million** in Q2 2021[137](index=137&type=chunk) - The company submitted the final major technical section (Chemistry, Manufacturing, and Controls - CMC) for its Re-Tain™ drug to the FDA in Q1 2021, with a response anticipated in Q3 2021 and potential product approval ranging from Q4 2021 to Q2 2022, assuming two review cycles[168](index=168&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=51&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company assesses its market risk as low, with its **$8.9 million bank debt** bearing a fixed **3.50% interest rate**, and no significant historical effect from inflation or currency rates - The company's market risk from interest rates is considered low, as its outstanding bank debt of approximately **$8.9 million** bears a fixed rate of **3.50%**[193](index=193&type=chunk) [Controls and Procedures](index=51&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal controls over financial reporting were effective as of March 31, 2021, with no material changes - Management concluded that the company's disclosure controls and procedures, as well as internal controls over financial reporting, were effective as of March 31, 2021[194](index=194&type=chunk)[195](index=195&type=chunk) [PART II: OTHER INFORMATION](index=53&type=section&id=PART%20II%3A%20OTHER%20INFORMATION) [Legal Proceedings](index=53&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not currently subject to any pending or threatened legal proceedings that would materially affect its business or financial condition - As of the filing date, the company is not involved in any material legal proceedings[199](index=199&type=chunk) [Risk Factors](index=53&type=section&id=ITEM%201A.%20Risk%20Factors) The company faces key risks including financial targets, debt covenants, reliance on First Defense, customer concentration, production constraints, Re-Tain™ regulatory hurdles, and global economic impacts - **Financial Risk:** The company may not achieve its gross margin goals (target near **50%**) or meet its debt service coverage ratio covenant in future years without a waiver[200](index=200&type=chunk)[202](index=202&type=chunk) - **Product & Concentration Risk:** The company is highly reliant on the First Defense product line, which constituted **98%** of sales in Q1 2021, with sales concentrated with two large distributors accounting for **78%** of sales[209](index=209&type=chunk)[210](index=210&type=chunk) - **Production Risk:** The inability to meet market demand due to production capacity constraints is a major risk, evidenced by a **$3.1 million** order backlog as of March 31, 2021, which could lead to customer loss[212](index=212&type=chunk) - **Regulatory Risk:** The commercial launch of Re-Tain™ is entirely dependent on obtaining FDA approval, and there is a risk that the required approvals for the product and manufacturing facilities could be delayed or not obtained[215](index=215&type=chunk) - **Global Risk:** The COVID-19 pandemic continues to create uncertainty, affecting the supply of raw materials, demand for products, and the economic health of customers in the dairy and beef industries[226](index=226&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=62&type=section&id=ITEM%202%20-%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) No unregistered sales of equity securities or use of proceeds were reported for the period [Defaults Upon Senior Securities](index=62&type=section&id=ITEM%203%20-%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) No defaults upon senior securities were reported for the period [Mine Safety Disclosures](index=62&type=section&id=ITEM%204%20-%20MINE%20SAFETY%20DISCLOSURES) No mine safety disclosures were reported for the period [Other Information](index=62&type=section&id=ITEM%205%20-%20OTHER%20INFORMATION) No other material information was reported for the period [Exhibits](index=62&type=section&id=ITEM%206%20%E2%80%93%20EXHIBITS) The report includes various exhibits, such as officer certifications and XBRL data files - The report includes certifications required by Rule 13a-14(a) and Section 906 of the Sarbanes-Oxley Act, along with XBRL Instance Documents[241](index=241&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, 2020 Securities registered pursuant to Section 12(g) of the Act: Common Stock, par value $0.10 per share (Title of class) Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☑ Indicate by check mark if the Registrant is not requi ...

Financial Data and Key Metrics Changes - Product sales increased by 12% for the year ended December 31, 2020, compared to 2019, indicating consistent market share gains [3][4] - The company reported an expected year-over-year increase in net cash provided by operating activities of approximately $1.1 million, which included $938,000 in other income from the forgiveness of a paycheck protection program loan [7] Business Line Data and Key Metrics Changes - The backlog of orders was approximately $1.8 million as of December 31, 2020, compared to no backlog as of December 31, 2019, reflecting strong demand for products [4] - Product development expenses increased by 18% to $4.4 million during 2020, including $1.5 million of non-cash depreciation expense [6] Market Data and Key Metrics Changes - The dairy industry experienced volatility during the COVID pandemic, with low milk prices in early 2020 rebounding towards the end of the year, contributing to strong demand in the fourth quarter [23] - The company reported a significant increase in orders during the fourth quarter, attributed to both market recovery and effective sales strategies [22][23] Company Strategy and Development Direction - The company is focused on expanding production capacity, with a 100% increase in liquid processing operations and a 50% increase in freeze-drying operations expected to be completed in the second quarter of 2021 [4][5] - Plans for a mass market launch of the Re-Tain product are set for the second quarter of 2022, pending FDA approval [6] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of cash flows over GAAP net loss at this stage, highlighting the relevance of cash flow statements for tracking performance [7] - The company anticipates a decrease in sales during the first quarter of 2021 compared to the first quarter of 2020, but expects to return to growth in the second half of 2021 [5] Other Important Information - The company is preparing for potential international market expansion, with ongoing regulatory work and partnerships in territories like South Korea and Japan [39] Q&A Session Summary Question: Why did the submission of Re-Tain take longer than expected? - Management explained that the submission was complex and required careful preparation, leading to a delay [10] Question: What was the order fulfillment situation in the fourth quarter? - Management confirmed strong demand in the fourth quarter, with a significant backlog contributing to order fulfillment [22][23] Question: What is the company's international sales strategy? - The company is focusing on regulatory approvals and partnerships for international expansion, with plans to enter new markets in the future [39]

Financial Data and Key Metrics Changes - Product sales increased by 25% in Q3 2020, following a 9% increase in Q2 2020 and an 11% increase in Q1 2020 [8][9] - For the nine-month period ended September 30, 2020, product sales were up 15%, and up 17% for the trailing 12 months [8] - Gross margin improved to 46% in Q3 2020, a 3-point increase from Q2 2020 [13] Business Line Data and Key Metrics Changes - The sales team is focused on disrupting the traditional scour vaccine market with preformed antibodies, leading to consistent market share gains [9] - A backlog of orders was reduced from approximately $945,000 as of June 30 to about $130,000 as of September 30 [10] Market Data and Key Metrics Changes - The dairy industry is experiencing strong economic measures, positively impacting customer demand for products [33] Company Strategy and Development Direction - The company plans to increase production capacity to $23 million per year, and later to $30 million per year, with renovations to the new facility completed [11] - The expansion of liquid processing capacity by 100% and freeze-drying capacity by 50% is underway, expected to be realized by Q2 2021 [12] - The company is preparing for the market launch of Re-Tain in Q1 2022, pending FDA approval [24] Management's Comments on Operating Environment and Future Outlook - The COVID-19 pandemic has disrupted operations but has not significantly impacted production time [17] - The Paycheck Protection Program loan of nearly $938,000 has been fully forgiven, aiding in operational continuity [16] - Management remains optimistic about future sales growth and market demand [33] Other Important Information - Non-cash expenses, including depreciation and stock-based compensation, comprised about 38% of product development expenses for the nine-month period [19] - The company is on track to submit the Chemistry Manufacturing and Controls (CMC) technical section to the FDA before year-end [23] Q&A Session Summary Question: Is there any need to submit earlier than December 31 for FDA approval? - Management indicated that while there is a need, the submission will only occur when ready, focusing on product stability [29] Question: Can sales increase in the current quarter based on demand? - Management confirmed that demand for products remains strong, and they expect to report results early in January [33] Question: Are there plans for international sales of First Defense and Tri-Shield? - Management stated that they will focus on clearing the backlog in North America before expanding into new international markets [35] Question: How does a farmer identify subclinical mastitis in cows? - Farmers monitor somatic cell counts and cow behavior to identify health issues [45] Question: How does the farmer obtain the product? - The product is delivered similarly to existing antibiotics, making it familiar and easy for farmers to use [48] Question: What role do major suppliers play in the product launch? - Major suppliers will play a significant role in distribution, similar to the existing network for First Defense [50]