PORTLAND, Maine, May 08, 2024 (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, expects to report unaudited financial results for the quarter ended March 31, 2024 after the market closes on Tuesday, May 14, 2024. The Company is planning to host a conference call the next morning, Wednesday, ...

PORTLAND, Maine, May 08, 2024 (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, expects to report unaudited financial results for the quarter ended March 31, 2024 after the market closes on Tuesday, May 14, 2024. The Company is planning to host a conference call the next morning, Wednesday, ...

PORTLAND, Maine, April 09, 2024 (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 2024, which ended March 31, 2024. Preliminary, Unaudited Total Sales Results: 20242023$ Increase % IncreaseDuring the Three-Month P ...

Part I [Business](index=5&type=section&id=ITEM%201%20%E2%80%93%20BUSINESS) ImmuCell develops and markets animal health products for cattle, focusing on its First Defense line while navigating production challenges and advancing its Re-Tain drug candidate [Production Capacity Increase and Product Contamination](index=8&type=section&id=Production%20Capacity%20Increase%20and%20Product%20Contamination) The company invested to increase First Defense production capacity but faced significant contamination events in 2022-2023 that impacted output and costs - A series of investments began in 2019 to increase First Defense production capacity to approximately **$30 million per year**, with necessary facility expansions and equipment in place by the end of 2022[19](index=19&type=chunk) - Product contamination events in 2022 and 2023 resulted in charges to cost of goods sold of approximately **$589,000** and **$527,000**, respectively[20](index=20&type=chunk)[21](index=21&type=chunk) - The company believes corrective actions and improved processes will allow for sustained higher production output and help fulfill a large order backlog[20](index=20&type=chunk)[21](index=21&type=chunk) [Animal Health Products](index=8&type=section&id=Animal%20Health%20Products) The company's core offering is the First Defense product line, providing immediate, USDA-licensed immunity against the three leading causes of calf scours - The First Defense product line is the only USDA-licensed, orally delivered scours preventative with claims against **E. coli, coronavirus, and rotavirus**[22](index=22&type=chunk) - **Tri-Shield First Defense**, approved in Q4 2017, combines antibodies against all three major scours pathogens, differentiating it from competitors[24](index=24&type=chunk) - The company's marketing emphasizes providing "Immediate Immunity™" with a measured dose of antibodies; cumulative sales of First Defense exceeded **33 million doses** as of Q4 2023[22](index=22&type=chunk)[25](index=25&type=chunk) [Sales and Markets](index=10&type=section&id=Sales%20and%20Markets) The company is gaining market share in the scours preventative market and is preparing a controlled launch for Re-Tain to address the large subclinical mastitis market U.S. Scours Preventative Market Share (Calf-Level) | 2019 | 2020 | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | :--- | | 36% | 41% | 43% | 44% | 48% | U.S. Scours Preventative Market Share (Calf & Dam-Level) | 2019 | 2020 | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | :--- | | 11% | 13% | 13% | 14% | 14% | - The total domestic addressable market for scours preventatives is estimated at **$75.4 million** per year, with the calf-level segment at **$25.6 million**[32](index=32&type=chunk) - Re-Tain targets subclinical mastitis, which affects an estimated 20-40% of the U.S. dairy herd and costs the industry **~$2 billion annually**; its key feature is no FDA-required milk discard[36](index=36&type=chunk)[37](index=37&type=chunk)[42](index=42&type=chunk) - A **"Controlled Launch" strategy** is planned for Re-Tain over the first 18-24 months post-approval to ensure successful adoption and manage limited initial inventory[43](index=43&type=chunk) [Product Development](index=15&type=section&id=Product%20Development) The company's primary development focus is Re-Tain, a Nisin-based mastitis treatment, with a cumulative investment of approximately $28.1 million over 24 years - From January 1, 2000, to December 31, 2023, the company invested approximately **$28.1 million** in the development of Re-Tain[48](index=48&type=chunk) - In 2004, the company acquired full control of the animal health applications of Nisin, the active ingredient in Re-Tain, for approximately **$965,000**[49](index=49&type=chunk) - A risk assessment concluded that the risk of milk from Re-Tain treated cows interfering with cultured dairy products is **negligible** when used according to the product label[50](index=50&type=chunk) [Competition](index=16&type=section&id=Competition) ImmuCell competes with major animal health firms, differentiating First Defense with its broad-spectrum claim and Re-Tain with its novel formulation and expected market exclusivity - The First Defense product line's primary competitive advantage is being the only calf-level product providing protection against **E. coli, coronavirus, and rotavirus**[55](index=55&type=chunk) - Direct competitors for First Defense include Zoetis's Calf-Guard and Merck's BOVILIS Coronavirus, as well as dam-level vaccines from Elanco, Merck, and Zoetis[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk) - Potential competitors for Re-Tain include established mastitis antibiotic sellers like Boehringer Ingelheim, Merck, and Zoetis; the company expects a **five-year market exclusivity** period for Re-Tain post-approval[59](index=59&type=chunk) [Intellectual Property](index=17&type=section&id=Intellectual%20Property) The company relies on patents, trademarks, and trade secrets to protect its products, including a key patent for its pharmaceutical-grade Nisin manufacturing process - Owns U.S. Patent No. 10,023,617, which covers key aspects of the manufacturing process for **pharmaceutical-grade Nisin**, the active ingredient in Re-Tain[63](index=63&type=chunk) - Holds numerous registered trademarks in the U.S., Canada, and Iran, including **FIRST DEFENSE®, TRI-SHIELD®, and RE-TAIN®**[64](index=64&type=chunk) - Relies on confidentiality and proprietary rights agreements with employees and partners to protect trade secrets and other confidential information[62](index=62&type=chunk) [Government Regulation](index=17&type=section&id=Government%20Regulation) The company's products are subject to stringent regulation by the USDA for its biologics and the FDA for its veterinary drug candidate, Re-Tain - The First Defense product line is regulated by the **USDA**, while Re-Tain is regulated by the **FDA**[65](index=65&type=chunk) - Foreign sales require approvals from regulatory authorities in each country, a process often managed with the help of local experts[65](index=65&type=chunk) [Employees](index=18&type=section&id=Employees) The company employed 79 people as of the report date, with the majority in manufacturing, and considers its employee relations to be excellent - The company employs **79 people**, with the majority (51 full-time equivalents) in quality and manufacturing operations[67](index=67&type=chunk) [Risk Factors](index=18&type=section&id=ITEM%201A%E2%80%94%20RISK%20FACTORS) The company faces significant financial, product, regulatory, and economic risks, including margin pressures, debt, manufacturing issues, and reliance on its core product line [Financial Risks](index=18&type=section&id=Financial%20Risks) The company faces risks from failing to meet gross margin targets, a significant debt service burden, and covenant waivers indicating financial pressure - The company missed its gross margin goals, realizing **22% in 2023** and **41% in 2022**, against a target of 45% or more[70](index=70&type=chunk) - As of December 31, 2023, total outstanding debt was **$12.1 million**, with debt service payments projected to be approximately **$2.0 million** for each of the years 2024 and 2025[72](index=72&type=chunk) - The company received waivers for its Debt Service Coverage (DSC) ratio covenant for the years ended December 31, 2022 and 2023, indicating financial pressure[73](index=73&type=chunk) [Product Risks](index=21&type=section&id=Product%20Risks) Product risks include manufacturing contamination events, heavy reliance on the First Defense line for 99% of sales, and high customer concentration - Production contamination events and equipment failures in 2022 and 2023 resulted in **scrapped inventory and significant production slowdowns**[85](index=85&type=chunk) - The company is highly reliant on the First Defense product line, which constituted **99% of total product sales** in both 2023 and 2022[92](index=92&type=chunk)[93](index=93&type=chunk) - Sales are concentrated, with two large distributors accounting for **79% of product sales** in 2023[93](index=93&type=chunk) - Specific risks for Re-Tain include potential rejection of milk tanks due to inhibitor tests and the challenge of convincing producers to treat subclinical mastitis[86](index=86&type=chunk)[88](index=88&type=chunk) [Regulatory Risks](index=24&type=section&id=Regulatory%20Risks) The company faces critical regulatory risks, including obtaining final FDA approval for Re-Tain and maintaining compliance with USDA inspections for its existing products - In July 2023, the USDA issued a temporary **Voluntary Stop Distribution and Sale (VSDS)** on First Defense, which was rescinded in early August 2023[98](index=98&type=chunk) - **Final FDA approval for Re-Tain remains a major hurdle**, with the Chemistry, Manufacturing and Controls (CMC) section currently under review after multiple submissions[99](index=99&type=chunk) - The FDA conducted a pre-approval inspection of the Drug Substance (DS) facility in early 2024, resulting in one deficiency on a Form 483, to which the company has responded[99](index=99&type=chunk) [Economic Risks Pertaining to the Dairy and Beef Industries](index=25&type=section&id=Economic%20Risks%20Pertaining%20to%20the%20Dairy%20and%20Beef%20Industries) The company's performance is tied to the economic health of the dairy and beef industries, facing risks from declining cattle counts and volatile milk prices - The U.S. cattle count has been declining, reaching **87.2 million** as of January 1, 2024, which could affect the size of the addressable market[103](index=103&type=chunk) Average Class III Milk Price (per cwt) | Year | Price | % Change YoY | | :--- | :--- | :--- | | 2021 | $17.08 | (6)% | | 2022 | $21.96 | 29% | | 2023 | $17.02 | (22)% | Average Milk-To-Feed Price Ratio | Year | Ratio | % Change YoY | | :--- | :--- | :--- | | 2021 | 1.74 | (25)% | | 2022 | 1.91 | 10% | | 2023 | 1.69 | (12)% | [Cybersecurity](index=32&type=section&id=ITEM%201C%20%E2%80%93%20CYBERSECURITY) The company manages cybersecurity through its overall risk program with board oversight and has experienced no material incidents to date - The Board of Directors has overall oversight of cybersecurity risk, with operational responsibility delegated to the management team[131](index=131&type=chunk) - The company engages outside consultants to assess, identify, and manage material cybersecurity risks[130](index=130&type=chunk) - **No known cybersecurity risks have materially affected the company to date**, but the risk of future incidents remains[130](index=130&type=chunk) [Properties](index=32&type=section&id=ITEM%202%20%E2%80%94%20PROPERTIES) ImmuCell owns and leases several properties in Portland, Maine, for its office, lab, and manufacturing operations for both USDA and FDA-regulated products - Owns a **34,850 sq. ft. facility** at 56 Evergreen Drive, Portland, ME, for office, lab, and USDA-regulated production[132](index=132&type=chunk) - Owns a **16,202 sq. ft. FDA-regulated facility** at 33 Caddie Lane for Re-Tain Drug Substance (DS) manufacturing[133](index=133&type=chunk) - Leases approximately **29,700 sq. ft.** of manufacturing and warehouse space at 175 Industrial Way to support the expansion of the First Defense product line[136](index=136&type=chunk)[137](index=137&type=chunk) [Legal Proceedings](index=33&type=section&id=ITEM%203%20%E2%80%94%20LEGAL%20PROCEEDINGS) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business or financial condition - The company does not believe any pending or threatened legal proceedings will have a **material adverse effect** on its business[139](index=139&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=34&type=section&id=ITEM%205%20%E2%80%94%20MARKET%20FOR%20REGISTRANT'S%20COMMON%20EQUITY,%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's common stock trades on Nasdaq (ICCC), with 7,750,864 shares outstanding as of March 2024, and it does not currently pay dividends - Common stock trades on Nasdaq under the symbol **ICCC**[142](index=142&type=chunk) - As of March 8, 2024, there were **7,750,864 shares outstanding**[142](index=142&type=chunk) - The company **does not currently pay dividends** and has no plans to in the future[142](index=142&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=ITEM%207%20%E2%80%94%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Financial performance in 2023 was severely impacted by production issues, leading to a 6% sales decrease, a drop in gross margin to 22%, and a widened net loss of $5.8 million [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity was strained in 2023, with cash from operations turning negative, cash balances falling 83%, and debt increasing to $12 million to fund operations - Net cash used for operating activities was **$4.7 million** in 2023, a significant increase from **$1.5 million** used in 2022, largely due to a **$3.3 million** increase in net loss[145](index=145&type=chunk) Selected Balance Sheet Data (in thousands) | | As of Dec 31, 2023 | As of Dec 31, 2022 | Change Amount | Change % | | :--- | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $979 | $5,792 | $(4,813) | (83)% | | Net working capital | $7,272 | $10,923 | $(3,650) | (33)% | | Total assets | $43,808 | $44,861 | $(1,053) | (2)% | | Stockholders' equity | $24,993 | $30,380 | $(5,387) | (18)% | - Total debt outstanding was approximately **$12 million** as of December 31, 2023, up from **$10.2 million** in 2022[146](index=146&type=chunk) - The company has deferred approximately **$5.5 million** in planned capital expenditures for First Defense and Re-Tain projects due to recent financial performance[154](index=154&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Product sales fell 6% to $17.5 million in 2023, gross margin dropped to 22% from 41%, and the net loss widened to $5.8 million due to production disruptions Annual Product Sales (in thousands) | | 2023 | 2022 | (Decrease) Amount | % | | :--- | :--- | :--- | :--- | :--- | | Total product sales | $17,472 | $18,568 | $(1,096) | (6)% | Annual Gross Margin (in thousands) | | 2023 | 2022 | (Decrease) Amount | % | | :--- | :--- | :--- | :--- | :--- | | Gross margin | $3,869 | $7,649 | $(3,779) | (49)% | | Percent of product sales | 22% | 41% | (19)% | (46)% | Annual Net Loss (in thousands, except per share) | | 2023 | 2022 | | :--- | :--- | :--- | | Net Operating Loss | $(5,748) | $(2,299) | | Net Loss | $(5,775) | $(2,494) | | Net Loss Per Share | $(0.75) | $(0.32) | [Critical Accounting Policies](index=52&type=section&id=Critical%20Accounting%20Policies) Key critical accounting policies involve significant estimates for inventory valuation, long-lived assets, and deferred tax assets, with revenue recognized at shipment - Revenue is recognized at the time of shipment, as title and risk of loss pass to the customer, in accordance with **ASC 606**[228](index=228&type=chunk) - Inventory is valued at the **lower of cost (FIFO) or net realizable value**, a critical estimate due to the variability of biological yields impacting cost per dose[229](index=229&type=chunk)[328](index=328&type=chunk) - Other significant estimates include the valuation of long-lived assets, deferred tax assets, and costs of goods sold[226](index=226&type=chunk) [Financial Statements and Supplementary Data](index=53&type=section&id=ITEM%208%20%E2%80%94%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) This section presents the audited financial statements for 2023 and 2022, with the auditor's report highlighting inventory valuation as a Critical Audit Matter Balance Sheet Summary (As of Dec 31, in thousands) | | 2023 | 2022 | | :--- | :--- | :--- | | Total Current Assets | $11,470 | $13,995 | | Total Assets | $43,808 | $44,861 | | Total Current Liabilities | $4,197 | $3,072 | | Total Liabilities | $18,815 | $14,481 | | Total Stockholders' Equity | $24,993 | $30,380 | Statement of Operations Summary (Year ended Dec 31, in thousands) | | 2023 | 2022 | | :--- | :--- | :--- | | Product Sales | $17,472 | $18,568 | | Gross Margin | $3,869 | $7,649 | | Net Operating Loss | $(5,748) | $(2,299) | | Net Loss | $(5,775) | $(2,494) | Statement of Cash Flows Summary (Year ended Dec 31, in thousands) | | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used for operating activities | $(4,674) | $(1,544) | | Net cash used for investing activities | $(1,890) | $(3,964) | | Net cash provided by financing activities | $1,751 | $1,114 | | Net decrease in cash | $(4,813) | $(4,394) | - The independent auditor, Wipfli LLP, identified the **'Valuation of Inventory' as a Critical Audit Matter** due to the complexity and judgment required in determining its cost[327](index=327&type=chunk)[328](index=328&type=chunk) [Controls and Procedures](index=53&type=section&id=ITEM%209A%20%E2%80%94%20CONTROLS%20AND%20PROCEDURES) Management concluded disclosure controls were effective as of year-end 2023, after remediating a material weakness related to inventory capitalization during the year - Management concluded that disclosure controls and procedures were **effective** as of December 31, 2023[231](index=231&type=chunk) - A **material weakness** related to capitalizing depreciation into inventory was identified in Q2 2023 and **remediated in Q3 2023**[235](index=235&type=chunk) - Management concluded that internal controls over financial reporting were **effective** as of December 31, 2023[235](index=235&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=55&type=section&id=ITEM%2010%20%E2%80%94%20DIRECTORS,%20EXECUTIVE%20OFFICERS%20AND%20CORPORATE%20GOVERNANCE) The company separates the CEO and independent Board Chair roles, maintains three independent board committees, and has adopted a Code of Business Conduct - The company maintains a separate President/CEO (Michael F. Brigham) and an **independent, non-executive Chair of the Board** (Dr. David S. Tomsche)[240](index=240&type=chunk) - The Board has three standing committees: Audit, Compensation and Stock Option, and Nominating, each composed of **independent directors**[242](index=242&type=chunk) - All directors and executive officers were compliant with Section 16(a) beneficial ownership reporting requirements for fiscal year 2023[268](index=268&type=chunk) [Executive Compensation](index=62&type=section&id=ITEM%2011%20%E2%80%94%20EXECUTIVE%20COMPENSATION) Executive compensation includes base salary, bonuses, and stock options, with CEO Michael F. Brigham's total 2023 compensation being $395,235 2023 Summary Compensation Table | Name and Principal Position | Year | Salary | Bonus | All Other Comp. | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | Michael F. Brigham, President & CEO | 2023 | $355,267 | $0 | $39,968 | $395,235 | | Bobbi Jo Brockmann, VP Sales & Mktg | 2023 | $268,846 | $25,000 | $29,675 | $323,521 | | Elizabeth L. Williams, VP Mfg Ops | 2023 | $264,173 | $25,000 | $22,899 | $312,072 | - Non-employee directors received an annual cash fee of **$28,000** in 2023, plus additional fees for committee service and the Board Chair role[272](index=272&type=chunk) - The company has an Amended and Restated Separation and Deferred Compensation Agreement with CEO Michael F. Brigham, which includes provisions for payment of unused paid time off and up to **$300,000** in deferred compensation upon separation[287](index=287&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=67&type=section&id=ITEM%2012%20%E2%80%94%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) The Pessin family (15.3%) and Jonathan E. Rothschild (6.6%) are the largest beneficial owners, with all directors and officers as a group owning 6.6% Security Ownership of Major Holders (as of April 15, 2024) | Name of Beneficial Owner | Shares Beneficially Owned | Percent of Stock | | :--- | :--- | :--- | | Sandra F., Norman H. and Brian L. Pessin | 1,182,720 | 15.3% | | Jonathan E. Rothschild | 514,003 | 6.6% | | Directors and executive officers as a group (8 persons) | 524,148 | 6.6% | - As of December 31, 2023, 618,500 shares were to be issued upon exercise of outstanding options, and **202,000 shares remained available** for future issuance under equity compensation plans[297](index=297&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=68&type=section&id=ITEM%2013%20%E2%80%94%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS,%20AND%20DIRECTOR%20INDEPENDENCE) The company discloses a related party transaction with a distributor controlled by the Board Chair, and all non-employee directors are considered independent - A company controlled by Board Chair David S. Tomsche, Leedstone Inc., is a distributor of ImmuCell's products and purchased **$231,405** worth of products in 2023[298](index=298&type=chunk) - All directors are **independent** under NASDAQ rules except for company employees Michael F. Brigham and Bobbi Jo Brockmann[300](index=300&type=chunk) [Principal Accountant Fees and Services](index=68&type=section&id=ITEM%2014%20%E2%80%94%20PRINCIPAL%20ACCOUNTANT%20FEES%20AND%20SERVICES) The company paid its auditor, Wipfli LLP, a total of $140,550 in 2023, primarily for audit services, all of which were pre-approved by the Audit Committee Accountant Fees | | 2023 | 2022 | | :--- | :--- | :--- | | Audit Fees | $140,000 | $130,000 | | Audit-Related Fees | $550 | $19,000 | | Total | $140,550 | $149,000 | - The Audit Committee **pre-approves all auditing and permitted non-audit services** performed by the Independent Registered Public Accounting Firm[306](index=306&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=72&type=section&id=ITEM%2015%20%E2%80%94%20EXHIBITS%20AND%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists all filed exhibits, including corporate governance documents, material debt and lease agreements, and executive compensation plans - Lists key corporate governance documents, including the Certificate of Incorporation (3.1-3.6) and Bylaws (3.7)[316](index=316&type=chunk) - Includes material contracts such as the Rights Agreement (4.1), various debt agreements with Gorham Savings Bank and Maine Technology Institute (10.17-10.35), and lease agreements (10.14-10.16)[316](index=316&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk)[320](index=320&type=chunk) - Contains management compensation plans and agreements, including stock option plans (10.3, 10.5) and executive incentive and separation agreements (10.8-10.11)[316](index=316&type=chunk)[318](index=318&type=chunk)

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, 2023 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 2023 Earnings Conference Call August 11, 2023 9:00 AM ET Company Participants Joe Dorame - Lytham Partners, IR Michael Brigham - President and Chief Executive Officer Conference Call Participants Operator Good day, and welcome to the ImmuCell Corporation Reports Second Quarter Fiscal Year 2023 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask question ...

PART I: FINANCIAL INFORMATION [Unaudited Financial Statements](index=3&type=section&id=ITEM%201.%20Unaudited%20Financial%20Statements) For the six months ended June 30, 2023, ImmuCell Corporation reported a significant decrease in product sales and gross margin, leading to a net loss of **$3.7 million**, a substantial increase from the **$171 thousand** loss in the same period of 2022; the balance sheet shows a decrease in cash and cash equivalents from **$5.8 million** to **$1.5 million**, while total liabilities increased, primarily driven by production slowdowns due to contamination events [Balance Sheets](index=3&type=section&id=Balance%20Sheets) As of June 30, 2023, the company's balance sheet shows a significant reduction in cash and cash equivalents to **$1.45 million** from **$5.79 million** at year-end 2022, with total assets slightly decreasing to **$44.0 million**, while total liabilities increased to **$17.15 million** from **$14.48 million**, primarily due to a new **$1.0 million** line of credit, consequently decreasing total stockholders' equity from **$30.38 million** to **$26.86 million** Selected Balance Sheet Data (in thousands) | Account | June 30, 2023 | December 31, 2022 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $1,454 | $5,792 | ($4,338) | | Inventory | $7,536 | $6,039 | $1,497 | | Total current assets | $10,946 | $13,995 | ($3,049) | | Total Assets | $44,007 | $44,861 | ($854) | | Line of credit | $1,000 | $0 | $1,000 | | Total Liabilities | $17,150 | $14,481 | $2,669 | | Total stockholders' equity | $26,857 | $30,380 | ($3,523) | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) The company's financial performance significantly worsened in Q2 and H1 2023, with product sales falling **29%** to **$7.0 million** and gross margin plummeting **72%** to **$1.3 million** for the six months ended June 30, 2023, resulting in a net loss of **$3.7 million**, or **($0.48)** per share, compared to a **$171 thousand** loss, or **($0.02)** per share, in H1 2022 Statements of Operations Summary (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | YoY Change | H1 2023 | H1 2022 | YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Product sales | $3,533 | $3,861 | -8.5% | $6,979 | $9,861 | -29.2% | | Gross margin | $1,044 | $1,707 | -38.8% | $1,345 | $4,811 | -72.0% | | Net Operating Loss | ($1,304) | ($619) | +110.7% | ($3,561) | ($48) | +7318.8% | | Net Loss | ($1,380) | ($684) | +101.8% | ($3,695) | ($171) | +2060.8% | | Diluted net loss per share | ($0.18) | ($0.09) | +100.0% | ($0.48) | ($0.02) | +2300.0% | [Statements of Cash Flows](index=6&type=section&id=Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, net cash used for operating activities was **$3.4 million**, a sharp reversal from the **$1.0 million** provided in 2022, primarily due to increased net loss, while investing activities used **$1.4 million** and financing activities provided **$0.5 million**, resulting in an overall **$4.3 million** decrease in cash and cash equivalents Cash Flow Summary for the Six-Month Periods Ended June 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash (used for) provided by operating activities | ($3,443) | $1,012 | | Net cash used for investing activities | ($1,391) | ($1,740) | | Net cash provided by financing activities | $497 | $1,586 | | Net (decrease) increase in cash | ($4,337) | $858 | | Ending Cash and cash equivalents | $1,454 | $11,043 | [Notes to Unaudited Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Financial%20Statements) The notes detail business segments, accounting policies, and financial components, including the impact of production contamination on inventory and sales, debt obligations and covenant waivers, revenue concentration, stock option plans, and segment performance, with a subsequent event revealing a new **$3 million** debt facility closed in Q3 2023 - The company operates in two segments: Scours (First Defense product line) and Mastitis (Re-Tain development); production slowdowns in H1 2023 to remediate contamination events negatively impacted sales and gross margin[20](index=20&type=chunk)[120](index=120&type=chunk) - Inventory write-offs from scrapped product due to contamination events totaled **$305,334** during the first six months of 2023[56](index=56&type=chunk) - The company's bank waived the debt service coverage (DSC) ratio covenant for the year ending December 31, 2023, requiring a **1.35** DSC ratio for twelve-month periods ending in mid-to-late 2024[65](index=65&type=chunk) - In Q3 2023, the company closed on a new **$3 million** debt facility and received a **$250,000** business interruption insurance benefit related to production contamination losses[130](index=130&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the significant decline in H1 2023 financial performance to production slowdowns from contamination events, leading to a **29%** sales decrease and **72%** gross margin drop, creating an **$8.5 million** order backlog, while the company invests in capacity expansion and Re-Tain FDA approval, deferring some capital expenditures and securing a new **$3 million** debt facility in Q3 2023 for liquidity [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity tightened with cash dropping by **$4.3 million** in H1 2023 due to a **$3.5 million** increase in net loss, leading to deferral of approximately **$5.4 million** in planned capital expenditures, though existing cash, anticipated gross margin, and a new **$3 million** debt facility secured in Q3 2023 are expected to fund operations for at least the next 12 months - Net cash used for operating activities was **($3.4) million** in H1 2023, a **$4.5 million** negative swing from the **$1.0 million** provided in H1 2022, largely due to a **$3.5 million** increase in net loss[136](index=136&type=chunk) - The company has deferred spending on key capital projects due to the loss in gross margin: approximately **$1.7 million** for Re-Tain formulation/filling (Project D) and approximately **$3.7 million** for First Defense capacity expansion (Project H)[146](index=146&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) - Total investment in capital projects from 2014 through June 30, 2023, amounts to **$36.6 million**, with an estimated **$6.3 million** remaining to complete, though a significant portion is currently deferred[152](index=152&type=chunk) [Results of Operations](index=43&type=section&id=Results%20of%20Operations) The company's operating results were severely impacted by production contamination events in late 2022 and Q1 2023, leading to a **29%** sales decrease to **$7.0 million** and a **72%** gross margin decrease to **$1.3 million** for H1 2023, with net loss swelling to **$3.7 million**, as the company focuses on remediation, managing a significant order backlog, and advancing Re-Tain toward FDA approval - Production slowdowns in H1 2023 to remediate contamination events resulted in a **$305,000** charge to cost of goods sold and an increase in the order backlog from **$2.5 million** to **$8.5 million** as of August 4, 2023[159](index=159&type=chunk)[161](index=161&type=chunk) Sales Performance (in thousands) | Period | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Q2 | $3,533 | $3,861 | (9%) | | H1 | $6,979 | $9,861 | (29%) | | TTM | $15,686 | $20,455 | (23%) | Gross Margin Performance | Period | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Q2 | 30% | 44% | (14 p.p.) | | H1 | 19% | 49% | (30 p.p.) | | TTM | 27% | 48% | (21 p.p.) | - The company is preparing its third submission of the final Chemistry, Manufacturing and Controls (CMC) Technical Section for Re-Tain to the FDA, with approval of this section being the last major step before commercialization[184](index=184&type=chunk)[187](index=187&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=57&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is marked as 'Not applicable' in the report [Controls and Procedures](index=57&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2023, but identified a material weakness in internal control over financial reporting related to improper capitalization of non-cash depreciation into inventory, which would have understated inventory by approximately **$387,000**, an error detected and corrected before the 10-Q was issued, with remediation efforts underway - Management identified a material weakness in internal controls over financial reporting as of June 30, 2023[226](index=226&type=chunk) - The weakness was a failure to properly capitalize non-cash depreciation into inventory, which would have understated inventory by approximately **$387,000** if not corrected[226](index=226&type=chunk) - The company is implementing changes to remediate this material weakness during the third quarter of 2023[226](index=226&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=58&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not currently involved in any pending or threatened legal proceedings expected to have a material adverse effect on its business, financial condition, or results of operations - The company does not believe any pending or threatened legal proceedings will have a material adverse effect on its business[229](index=229&type=chunk) [Risk Factors](index=58&type=section&id=ITEM%201A.%20Risk%20Factors) The company outlines significant business risks, including financial risks from failing to meet gross margin goals and debt covenants, product risks from manufacturing contamination and reliance on First Defense, market acceptance uncertainties for Re-Tain, regulatory hurdles for FDA approval, economic pressures from the dairy and beef industries, competition, and global risks like inflation and supply chain disruptions [Financial Risks](index=58&type=section&id=Financial%20Risks) Key financial risks include the potential inability to achieve gross margin goals due to cost increases and production issues, as seen in H1 2023, risks related to approximately **$1.6 million** in 2023 debt service obligations, and the need to comply with a **1.35** debt service coverage ratio starting in mid-2024, with inflation also materially impacting supply and labor costs - There is a risk the company will not achieve its gross margin goals, which would adversely affect operating results, as experienced during H1 2023 due to contamination events[230](index=230&type=chunk) - The company's bank waived the debt service coverage (DSC) ratio covenant for 2023, but it must meet a **1.35** ratio for the twelve-month periods ending June 30, September 30, and December 31, 2024[232](index=232&type=chunk) [Product Risks](index=59&type=section&id=Product%20Risks) Significant product risks include potential future manufacturing contamination events, heavy reliance on the First Defense product line, which constituted **99%** of sales in H1 2023, and specific sales risks for the Re-Tain launch, such as potential milk rejection by processors and challenges in shifting producer practices to treat subclinical mastitis - The company is at risk of further production contaminations, which led to a production slowdown and reduced sales and gross margin in H1 2023[242](index=242&type=chunk) - The company is highly reliant on the First Defense product line, which accounted for **99%** of total product sales during the six-month period ended June 30, 2023[248](index=248&type=chunk)[249](index=249&type=chunk) - Sales of Re-Tain face risks such as potential rejection of milk by processors due to positive inhibitor tests and challenges in convincing producers to treat subclinical mastitis[243](index=243&type=chunk)[244](index=244&type=chunk)[245](index=245&type=chunk) [Regulatory Risks](index=62&type=section&id=Regulatory%20Risks) The company's operations are subject to periodic USDA inspections for First Defense products, with a July 2023 inspection resulting in a temporary halt on distribution and sales, while a major risk remains obtaining final FDA approval for Re-Tain, which hinges on a successful pre-approval re-inspection and approval of the final CMC Technical Section - In July 2023, the USDA imposed a temporary Voluntary Stop Distribution and Sale (VSDS) order on First Defense following an inspection, which has since been rescinded[253](index=253&type=chunk) - The commercial launch of Re-Tain requires FDA approval of the final Chemistry, Manufacturing and Controls (CMC) Technical Section, which is subject to risk and potential delays[254](index=254&type=chunk) [Other Risks](index=68&type=section&id=Other%20Risks) Other notable risks include reliance on a limited number of single-source suppliers for critical components like colostrum and syringes, dependence on a contract manufacturer for initial Re-Tain Drug Product supply, and risks related to protecting intellectual property and ensuring IT system security against cyberattacks - The company is dependent on its manufacturing facilities in Portland and on single-source suppliers for key components like syringes for Re-Tain[279](index=279&type=chunk) - The company relies on a contract with Norbrook for the initial supply of Re-Tain Drug Product, and any disruption could adversely affect the product launch[279](index=279&type=chunk) [Exhibits](index=70&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including an amendment to the Rights Agreement, loan agreements for the new **$3 million** debt facility, and required officer certifications

ImmuCell Corporation (NASDAQ:ICCC) Q1 2023 Earnings Conference Call May 12, 2023 9:00 AM ET Company Participants Joe Diaz - Managing Partner, Lytham Partners Michael Brigham - President and CEO Operator Good morning, and welcome to ImmuCell Corporation Reports First Quarter 2023 Unaudited Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Joe Diaz of Lytham Partn ...

PART I: FINANCIAL INFORMATION [Unaudited Financial Statements](index=3&type=section&id=ITEM%201.%20Unaudited%20Financial%20Statements) Unaudited Q1 2023 financial statements reveal significant deterioration, marked by a net loss and negative operating cash flow due to production issues [Balance Sheets](index=3&type=section&id=Balance%20Sheets) - Cash and cash equivalents decreased by **$2.7 million**, from **$5.8 million** at year-end 2022 to **$3.1 million** as of March 31, 2023[8](index=8&type=chunk) - Total liabilities increased by approximately **$0.5 million** during the quarter, primarily due to a **$1.0 million** draw on the line of credit[8](index=8&type=chunk) - Stockholders' equity decreased by **$2.2 million**, driven by the net loss of **$2.3 million** for the quarter[12](index=12&type=chunk) Balance Sheet Summary (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,096 | $5,792 | | Total current assets | $12,248 | $13,995 | | Property, plant and equipment, net | $28,461 | $28,442 | | **Total Assets** | **$43,123** | **$44,861** | | **Liabilities & Equity** | | | | Total current liabilities | $3,838 | $3,072 | | Total long-term liabilities | $11,124 | $11,409 | | **Total Liabilities** | **$14,962** | **$14,481** | | **Total stockholders' equity** | **$28,161** | **$30,380** | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) - Product sales plummeted by **43%** year-over-year, from **$6.0 million** in Q1 2022 to **$3.4 million** in Q1 2023[10](index=10&type=chunk) - Gross margin collapsed to **$301,000** (**9%** of sales) from **$3.1 million** (**52%** of sales) in the prior-year period[10](index=10&type=chunk) - The company reported a **net loss of $2.3 million**, or **($0.30) per share**, a significant reversal from the **net income of $513,000**, or **$0.07 per share**, in Q1 2022[10](index=10&type=chunk) Quarterly Statement of Operations (in thousands, except per share data) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Product sales | $3,447 | $6,000 | | Gross margin | $301 | $3,103 | | Operating expenses | $2,557 | $2,533 | | **Net Operating (Loss) Income** | **($2,256)** | **$571** | | **Net (Loss) Income** | **($2,315)** | **$513** | | **Diluted net (loss) income per share** | **($0.30)** | **$0.07** | [Statements of Cash Flows](index=6&type=section&id=Statements%20of%20Cash%20Flows) - Net cash used for operating activities was **$2.8 million**, a **$3.4 million** negative swing from the **$639,000** of cash provided by operations in Q1 2022, primarily due to the net loss[15](index=15&type=chunk)[132](index=132&type=chunk) - Cash used for investing activities was **$682,000**, mainly for the purchase of property, plant, and equipment[15](index=15&type=chunk) - Net cash provided by financing activities was **$749,000**, largely from a **$1.0 million** draw on the line of credit, offset by debt principal repayments[15](index=15&type=chunk) [Notes to Unaudited Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Financial%20Statements) - The company operates in two business segments: **Scours (First Defense product line)** and **Mastitis (Re-Tain development)**[20](index=20&type=chunk)[117](index=117&type=chunk) - There is a high concentration of credit risk, with two customers (Company A and Company B) accounting for **77%** of total product sales and **71%** of total trade accounts receivable[38](index=38&type=chunk) - As of March 31, 2023, the company had total debt obligations of approximately **$10.0 million** (excluding line of credit), with principal payments of **$1.1 million** due in 2024[69](index=69&type=chunk)[133](index=133&type=chunk) Segment Operating Results - Q1 2023 (in thousands) | Segment | Product Sales | Gross Margin | Net Operating Loss | | :--- | :--- | :--- | :--- | | Scours | $3,411 | $307 | ($384) | | Mastitis | $35 | ($6) | ($1,272) | | Other | $0 | $0 | ($601) | | **Total** | **$3,446** | **$301** | **($2,256)** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes poor Q1 2023 results to production contamination, causing sales decline, gross margin collapse, and capital expenditure deferrals, while focusing on remediation and Re-Tain FDA approval [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) - Net cash used for operating activities was **$2.8 million** in Q1 2023, a **$3.4 million** negative swing from Q1 2022, largely due to the net loss from the production slowdown[132](index=132&type=chunk) - The company's bank, Gorham Savings Bank (GSB), waived the debt service coverage (DSC) ratio covenant for the year ending December 31, 2023; the company must meet a **1.35 DSC ratio** for the twelve-month periods ending in mid-to-late 2024[133](index=133&type=chunk) - Due to the loss in gross margin, the company has decided to defer spending on capital projects, including approximately **$1.7 million** for Re-Tain formulation/filling (Project D) and **$4.2 million** for First Defense capacity expansion (Project H)[142](index=142&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk) [Results of Operations](index=42&type=section&id=Results%20of%20Operations) - A product contamination event detected in Q1 2023 forced a production slowdown, causing the order backlog to increase from **$2.5 million** at year-end 2022 to approximately **$8 million** as of May 3, 2023[154](index=154&type=chunk)[155](index=155&type=chunk) Quarterly Financial Performance Summary | Metric | Q1 2023 | Q1 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Total product sales | $3.4M | $6.0M | (43)% | | Gross margin | $0.3M | $3.1M | (90)% | | Gross margin % | 9% | 52% | (83)% | - The final major step for Re-Tain approval, the Chemistry, Manufacturing and Controls (CMC) Technical Section, is now projected to be submitted to the FDA during the **second quarter of 2023**, a delay from the previous end-of-April target[178](index=178&type=chunk) - The company projects Re-Tain sales of approximately **$1 million** in the first year post-launch, doubling to **$2 million** in the second year, under a controlled launch strategy[198](index=198&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=56&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable for the registrant - This section is not applicable for the registrant[213](index=213&type=chunk) [Controls and Procedures](index=56&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting - Management evaluated the effectiveness of disclosure controls and procedures as of March 31, 2023, and concluded that they were effective[213](index=213&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[214](index=214&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=57&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not subject to any pending or threatened legal proceedings that would materially adversely affect its business or financial condition - The company is not aware of any pending or threatened legal proceedings that would have a material adverse effect on its business[216](index=216&type=chunk) [Risk Factors](index=57&type=section&id=ITEM%201A.%20Risk%20Factors) The company faces significant financial, product, regulatory, economic, and operational risks, including manufacturing issues, Re-Tain launch challenges, and market volatility [Financial Risks](index=57&type=section&id=Financial%20Risks) - There is a risk that the company cannot achieve its gross margin goal of approaching **50%** (before depreciation) due to cost increases, manufacturing contamination events, or inability to raise prices[217](index=217&type=chunk) - The company's debt service coverage (DSC) ratio was **0.44** for 2022, below the required level, necessitating a waiver from its bank; failure to meet future DSC requirements could result in a covenant violation[219](index=219&type=chunk) - Inflation is having a material adverse impact on the cost of supplies and labor, which could reduce gross margin if not offset by price increases[222](index=222&type=chunk) [Product Risks](index=58&type=section&id=Product%20Risks) - The company is at risk of further production contaminations, similar to those experienced in late 2022 and Q1 2023, which could result in more scrapped inventory and production slowdowns[229](index=229&type=chunk) - The successful launch of Re-Tain faces risks including potential for positive milk inhibitor tests, failed cheese tanks if milk concentration limits are exceeded, and the need to change producer behavior from treating only clinical mastitis to treating subclinical disease[230](index=230&type=chunk)[231](index=231&type=chunk)[232](index=232&type=chunk) - The business is highly reliant on the First Defense product line, which accounted for **99%** of total sales in Q1 2023[235](index=235&type=chunk)[236](index=236&type=chunk) [Regulatory Risks](index=60&type=section&id=Regulatory%20Risks) - The commercial launch of Re-Tain requires FDA approval of the final Chemistry, Manufacturing and Controls (CMC) Technical Section and a successful pre-approval re-inspection of the manufacturing facility, which presents a risk of delay or non-approval[241](index=241&type=chunk) [Economic Risks Pertaining to the Dairy and Beef Industries](index=60&type=section&id=Economic%20Risks%20Pertaining%20to%20the%20Dairy%20and%20Beef%20Industries) - The U.S. cattle count has been declining, reaching **89.3 million** as of January 1, 2023, which could negatively affect the size of the addressable market[243](index=243&type=chunk) - The dairy market is highly volatile; the Class III milk price, a key revenue indicator for customers, has seen significant fluctuations, and the milk-to-feed price ratio remains low, indicating financial pressure on producers[248](index=248&type=chunk) [Small Size of Company](index=64&type=section&id=Small%20Size%20of%20Company) - As a small company with **74 employees**, there is a heavy reliance on key personnel with limited redundancy, and their loss could adversely affect operations[251](index=251&type=chunk) - The company is dependent on its contract manufacturer, Norbrook, for Re-Tain Drug Product (DP) supply in **2023**; there is a risk of supply interruption in managing the transition to in-house DP production, which is expected to be operational in **2025**[252](index=252&type=chunk) [Global Risks](index=64&type=section&id=Global%20Risks) - The company faces significant production constraints, supply disruptions, and inflation caused in part by the global COVID-19 pandemic and Russia's invasion of Ukraine[254](index=254&type=chunk) - Climate change poses risks through potential disruption to the company's activities and those of its customers and suppliers, including altered weather patterns and increased prevalence of livestock diseases[258](index=258&type=chunk) [Risks Pertaining to Common Stock](index=66&type=section&id=Risks%20Pertaining%20to%20Common%20Stock) - The company's common stock has low average daily trading volume, which can lead to price volatility and difficulty for investors looking to sell shares[260](index=260&type=chunk) - Anti-takeover provisions, including a Common Stock Rights Plan (poison pill), may discourage or prevent a change in control that stockholders might consider favorable[261](index=261&type=chunk)[262](index=262&type=chunk) [Other Items (2-6)](index=68&type=section&id=ITEM%202-6) Items 2 through 5 are reported as "None", while Item 6 lists the exhibits filed with the report - There were no unregistered sales of equity securities, defaults upon senior securities, mine safety disclosures, or other information to report for the period[271](index=271&type=chunk) - Item 6 lists the exhibits filed with the Form 10-Q, including management compensation agreements and required certifications[274](index=274&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, 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, Maine | 04103 | | (Address of principal exec ...