Immucell Corp 10-Q for FY2022 Q2
Immucell Corp (ICCC)
About this 10-Q
Immucell Corp filed this 10-Q on August 11, 2022, covering the quarter ended June 30, 2022 (FY2022 Q2).
Headline figures
Quarter ended June 30, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $3.86M
- down 15.0% from $4.54M a year earlier
- Net loss
- $684.15K
- compared with net income of $141.11K a year earlier
- Diluted EPS
- -$0.09
- compared with $0.02 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
(Commission file number)
(Exact name of registrant as specified in its charter)
| (State of Incorporation) | (I.R.S. Employer Identification No.) |
| (Address of principal executive office) | (Zip Code) |
(Registrant’s telephone number)
Securities registered pursuant to Section 12(b) of the Exchange Act:
|
Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months
(or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| ☒ | Smaller reporting company | ||
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
The number of shares of the registrant’s common stock outstanding
as of August 2, 2022 was
ImmuCell Corporation
|
TABLE OF CONTENTS June 30, 2022 |
i
ImmuCell Corporation
PART 1. FINANCIAL INFORMATION
ITEM 1. UNAUDITED FINANCIAL STATEMENTS
BALANCE SHEETS
| (Unaudited) As of June 30, 2022 | As of December 31, 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Trade accounts receivable, net | ||||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| PROPERTY, PLANT AND EQUIPMENT, net | ||||||||
| OPERATING LEASE RIGHT-OF-USE ASSET | ||||||||
| GOODWILL | ||||||||
| INTANGIBLE ASSETS, net | ||||||||
| OTHER ASSETS | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current portion of debt obligations | $ | $ | ||||||
| Current portion of operating lease liability | ||||||||
| Accounts payable and accrued expenses | ||||||||
| Total current liabilities | ||||||||
| LONG-TERM LIABILITIES: | ||||||||
| Debt obligations, net of current portion | ||||||||
| Operating lease liability, net of current portion | ||||||||
| Total long-term liabilities | ||||||||
| TOTAL LIABILITIES | ||||||||
| CONTINGENT LIABILITIES AND COMMITMENTS (See Note 11) | ||||||||
| STOCKHOLDERS’ EQUITY: | ||||||||
| Common stock, $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Treasury stock, at cost, | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited financial statements.
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ImmuCell Corporation
STATEMENTS OF OPERATIONS
(Unaudited)
During the Three-Month Periods | During the Six-Month Periods | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Product sales | $ | $ | $ | $ | ||||||||||||
| Costs of goods sold | ||||||||||||||||
| Gross margin | ||||||||||||||||
| Product development expenses | ||||||||||||||||
| Sales and marketing expenses | ||||||||||||||||
| Administrative expenses | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| NET OPERATING (LOSS) INCOME | ( | ) | ( | ) | ||||||||||||
| Other expenses, net | ||||||||||||||||
| (LOSS) INCOME BEFORE INCOME TAXES | ( | ) | ( | ) | ||||||||||||
| Income tax expense | — | |||||||||||||||
| NET (LOSS) INCOME | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
| Basic weighted average common shares outstanding | ||||||||||||||||
| Basic net (loss) income per share | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
| Diluted weighted average common shares outstanding | ||||||||||||||||
| Diluted net (loss) income per share | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
The accompanying notes are an integral part of these unaudited financial statements.
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ImmuCell Corporation
STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
| Common Stock | Treasury Stock | |||||||||||||||||||||||||||
| Shares | Amount | Additional paid-in capital | Accumulated Deficit | Shares | Amount | Total Stockholders’ Equity | ||||||||||||||||||||||
| During the Three-Month Period Ended June 30, 2022: | ||||||||||||||||||||||||||||
| BALANCE, | ||||||||||||||||||||||||||||
| March 31, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Net loss | — | ( | ) | — | ( | ) | ||||||||||||||||||||||
| Exercise of stock options | ( | ) | ||||||||||||||||||||||||||
| Stock-based compensation | — | — | ||||||||||||||||||||||||||
| BALANCE, | ||||||||||||||||||||||||||||
| June 30, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| During the Three-Month Period Ended June 30, 2021: | ||||||||||||||||||||||||||||
| BALANCE, | ||||||||||||||||||||||||||||
| March 31, 2021 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Net income | — | — | ||||||||||||||||||||||||||
| Public offering of common stock, net of $ | ||||||||||||||||||||||||||||
| Exercise of stock options | ( | ) | ( | ) | ||||||||||||||||||||||||
| Stock-based compensation | — | — | ||||||||||||||||||||||||||
| BALANCE, | ||||||||||||||||||||||||||||
| June 30, 2021 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| During the Six-Month Period Ended June 30, 2022: | ||||||||||||||||||||||||||||
| BALANCE, | ||||||||||||||||||||||||||||
| December 31, 2021 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Net income | — | — | ||||||||||||||||||||||||||
| Exercise of stock options | ( | ) | ||||||||||||||||||||||||||
| Stock-based compensation | — | — | ||||||||||||||||||||||||||
| BALANCE, | ||||||||||||||||||||||||||||
| June 30, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| During the Six-Month Period Ended June 30, 2021: | ||||||||||||||||||||||||||||
| BALANCE, | ||||||||||||||||||||||||||||
| December 31, 2020 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Net loss | — | ( | ) | — | ( | ) | ||||||||||||||||||||||
| Public offering of common stock, net of $ | ||||||||||||||||||||||||||||
| Exercise of stock options | ( | ) | ( | ) | ||||||||||||||||||||||||
| Stock-based compensation | — | — | ||||||||||||||||||||||||||
| BALANCE, | ||||||||||||||||||||||||||||
| June 30, 2021 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
The accompanying notes are an integral part of these unaudited financial statements.
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ImmuCell Corporation
STATEMENTS OF CASH FLOWS
(Unaudited)
| During the Six-Month Periods Ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net income (loss) | $ | $ | ( | ) | ||||
| Adjustments to reconcile net income (loss) to net cash provided by (used for) operating activities: | ||||||||
| Depreciation | ||||||||
| Amortization of intangible assets | ||||||||
| Amortization and write-off of debt issuance costs | ||||||||
| Stock-based compensation | ||||||||
| Gain on disposal of fixed assets | ( | ) | ( | ) | ||||
| Non-cash rent expense | ||||||||
| Changes in: | ||||||||
| Trade accounts receivable | ( | ) | ||||||
| Accrued interest income | — | |||||||
| Inventory | ( | ) | ( | ) | ||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Other assets | ||||||||
| Accounts payable and accrued expenses | ( | ) | ( | ) | ||||
| Net cash provided by operating activities | ||||||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchase of property, plant and equipment | ( | ) | ( | ) | ||||
| Maturities of investments | — | |||||||
| Proceeds from sale of fixed assets | ||||||||
| Net cash used for investing activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Proceeds from public offering, net | — | |||||||
| Proceeds from debt issuance | — | |||||||
| Debt principal repayments | ( | ) | ( | ) | ||||
| Payments of debt issuance costs | ( | ) | ||||||
| Proceeds from exercise of stock options | ||||||||
| Net cash provided by financing activities | ||||||||
| NET INCREASE IN CASH AND CASH EQUIVALENTS | ||||||||
| BEGINNING CASH AND CASH EQUIVALENTS | ||||||||
| ENDING CASH AND CASH EQUIVALENTS | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited financial statements.
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ImmuCell Corporation
STATEMENTS OF CASH FLOWS
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
(Unaudited)
| During the Six-Month Periods Ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| CASH PAID FOR: | ||||||||
| Income taxes | $ | $ | ||||||
| Interest expense | $ | $ | ||||||
| NON-CASH ACTIVITIES: | ||||||||
| Change in capital expenditures included in accounts payable and accrued expenses | $ | ( | ) | $ | ( | ) | ||
The accompanying notes are an integral part of these unaudited financial statements.
5
ImmuCell Corporation
Notes to Unaudited Financial Statements
1. BUSINESS OPERATIONS
ImmuCell Corporation (the “Company”, “we”, “us”, “our”) was originally incorporated in Maine in 1982 and reincorporated in Delaware in 1987, in conjunction with our initial public offering of common stock. We are an animal health company whose purpose is to create scientifically-proven and practical products that improve the health and productivity of dairy and beef cattle. As disclosed in Note 17, “Segment Information”, one of our business segments is dedicated to Scours and the other is focused on Mastitis. We manufacture and market the First Defense® product line, providing Immediate Immunity™ to prevent scours in newborn dairy and beef calves. We have expanded this line into four different products with formulations targeting E. coli, coronavirus and rotavirus pathogens. We are also in the late stages of developing Re-Tain®, a treatment for lactating dairy cows with subclinical mastitis. Mastitis is the most significant cause of economic loss to the dairy industry. These products help reduce the need to use traditional antibiotics in food producing animals. We are subject to certain risks including dependence on key individuals and third-party providers of critical goods and services, competition from other larger companies, the successful sale of existing products and the development of new viable products with appropriate regulatory approvals, where applicable.
The global COVID-19 pandemic has created, and continues to create, uncertainty for us. While conditions relating to the pandemic may be improving somewhat, the full impact of this viral outbreak on the global economy, and the duration of such impact, is still uncertain at this time. A combination of the conditions, trends and concerns related to or arising from the pandemic, as well as inflation, rising interest rates and potential recessionary conditions in the United States and/or internationally, could have a corresponding negative effect on our business and operations, including the supply of the colostrum we purchase to produce our First Defense® product line, the demand for our products in the U.S. market and our ability to penetrate or maintain a profitable presence in international markets. We are experiencing price increases and shortages in key components, supportive services, transportation and other supplies that may cause production slowdowns that affect our ability to consistently deliver our products to market on time in accordance with customer demand. Despite some recent favorable trends, we maintain our diligence because this is a risk to our business.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(a) Basis of Presentation
We have prepared the accompanying unaudited financial statements reflecting all adjustments (which are of a normal recurring nature) that are, in our opinion, necessary in order to ensure that the financial statements are not misleading. We follow accounting standards set by the Financial Accounting Standards Board (FASB). The FASB sets Generally Accepted Accounting Principles (GAAP) that we follow to ensure we accurately report our financial condition, results of operations, earnings per share and cash flows. References to GAAP in these footnotes are to the FASB Accounting Standards Codification™ (Codification). We believe that the disclosures are adequate to ensure that the information presented is not misleading.
(b) Cash and Cash Equivalents
We consider all highly liquid investment instruments
that mature within three months of their purchase dates to be cash equivalents. Cash equivalents are principally invested in securities
backed by the U.S. government. There are no cash equivalents in excess of Federal Deposit Insurance Corporation (FDIC) limits of $
(c) Trade Accounts Receivable, net
Accounts receivable are carried at the original invoice amount less an estimate made for doubtful collection when applicable. Management determines the allowance for doubtful accounts on a monthly basis by identifying troubled accounts and by using historical experience applied to an aging of accounts. Accounts receivable are considered to be past due if a portion of the receivable balance is outstanding for more than 30 days. Past due accounts receivable are subject to an interest charge. Accounts receivable are written off when deemed uncollectible. The amount of accounts receivable written off during all periods reported was immaterial. Recoveries of accounts receivable previously written off are recorded as income when received. As of June 30, 2022 and December 31, 2021, we determined that no allowance for doubtful accounts was necessary. See Note 4.
6
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
(d) Inventory
Inventory includes raw materials, work-in-process and finished goods and is recorded at the lower of cost, on the first-in, first-out method, or net realizable value (determined as the estimated selling price in the normal course of business, less reasonably predictable costs of completion, disposal and transportation). Work-in-process and finished goods inventories include materials, labor and manufacturing overhead. At each balance sheet date, we evaluate our ending inventories for excess quantities and obsolescence. Inventories that we consider excess or obsolete are written down to estimated net realizable value. Once inventory is written down and a new cost basis is established, it is not written back up if demand increases. We believe that supplies and raw materials for the production of our products are available from more than one vendor or farm. Our policy is to maintain more than one source of supply for the components used in our products when feasible. See Note 5.
(e) Property, Plant and Equipment, net
We depreciate property, plant and equipment on the
straight-line method by charges to operations and costs of goods sold in amounts estimated to expense the cost of the assets from the
date they are first put into service to the end of the estimated useful lives of the assets.
(f) Intangible Assets and Goodwill
We amortize intangible assets on the straight-line method by charges to costs of goods sold in amounts estimated to expense the cost of the assets from the date they are first put into service to the end of the estimated useful lives of the assets. We have recorded intangible assets related to customer relationships, non-compete agreements and developed technology, each with defined useful lives. We have classified as goodwill the amounts paid in excess of fair value of the net assets (including tax attributes) acquired in purchase transactions. We assess the impairment of intangible assets and goodwill that have indefinite lives at the reporting unit level on an annual basis (as of December 31st) and whenever events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. We would record an impairment charge if such an assessment were to indicate that the fair value of such assets was less than the carrying value. Judgment is required in determining whether an event has occurred that may impair the value of goodwill or identifiable intangible assets. Factors that could indicate that an impairment may exist include significant under-performance relative to plan or long-term projections, significant changes in business strategy and significant negative industry or economic trends. Although we believe intangible assets and goodwill are properly stated in the accompanying financial statements, changes in strategy or market conditions could significantly impact these judgments and require an adjustment to the recorded balance. No goodwill impairments were recorded during the six-month period ended June 30, 2022 or the year ended December 31, 2021. See Notes 2(g) and 8 for additional disclosures.
(g) Valuation of Long-Lived Assets
We periodically evaluate our long-lived assets, consisting principally of fixed assets, operating lease right-of-use asset and amortizable intangible assets, for potential impairment. In accordance with the applicable accounting guidance for the treatment of long-lived assets, we review the carrying value of our long-lived assets or asset group that is held and used, including intangible assets subject to amortization, for impairment whenever events and circumstances indicate that the carrying value of the assets may not be recoverable. Under the held for use approach, the asset or asset group to be tested for impairment should represent the lowest level for which identifiable cash flows are largely independent of the cash flows of other groups of assets and liabilities. We evaluate our long-lived assets whenever events or circumstances suggest that the carrying amount of an asset or group of assets may not be recoverable. No impairment was recognized during the six-month period ended June 30, 2022 or the year ended December 31, 2021.
7
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
(h) Fair Value Measurements
In determining fair value measurements, we follow the provisions of Codification Topic 820, Fair Value Measurements and Disclosures. Codification Topic 820 defines fair value, establishes a framework for measuring fair value under GAAP and enhances disclosures about fair value measurements. The topic provides a consistent definition of fair value which focuses on an exit price, which is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The topic also prioritizes, within the measurement of fair value, the use of market-based information over entity-specific information and establishes a three-level hierarchy for fair value measurements based on the nature of inputs used in the valuation of an asset or liability as of the measurement date. As of June 30, 2022 and December 31, 2021, the carrying amounts of cash and cash equivalents, accounts receivable, inventory, other assets, accounts payable and accrued liabilities approximate fair value because of their short-term nature. The amount outstanding under our bank debt facilities is measured at carrying value in our accompanying balance sheets. Our bank debt facilities are valued using Level 2 inputs. The estimated fair value of our bank debt facilities approximates their carrying value based on similar instruments with similar maturities. The three-level hierarchy is as follows:
| Level 1 — | Pricing inputs are quoted prices available in active markets for identical assets or liabilities as of the measurement date. |
| Level 2 — | Pricing inputs are quoted prices for similar assets or liabilities, or inputs that are observable, either directly or indirectly, for substantially the full term through corroboration with observable market data. |
| Level 3 — | Pricing inputs are unobservable for the assets or liabilities, that is, inputs that reflect the reporting entity’s own assumptions about the assumptions market participants would use in pricing the asset or liability. |
In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the level of an asset or liability within the fair value hierarchy is based on the lowest level of input that is significant to the fair value measurement. Our assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the investment. From time to time, we also hold money market mutual funds in a brokerage account, which are classified as cash equivalents and measured at fair value. The fair value of these investments is based on their closing published net asset value.
We assess the levels of the investments at each measurement date, and transfers between levels are recognized on the actual date of the event or change in circumstances that caused the transfer in accordance with our accounting policy regarding the recognition of transfers between levels of the fair value hierarchy. During the three-month period ended June 30, 2022 and the year ended December 31, 2021, there were no transfers between levels. As of June 30, 2022 and December 31, 2021, our Level 1 assets measured at fair value by quoted prices in active markets consisted of bank savings accounts and money market funds. There were no assets or liabilities measured at fair value on a nonrecurring basis as of June 30, 2022 or December 31, 2021.
As of June 30, 2022 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Assets: | ||||||||||||||||
| Cash and money market accounts | $ | $ | $ | $ | ||||||||||||
| Liabilities: | ||||||||||||||||
| Bank debt | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
As of December 31, 2021 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Assets: | ||||||||||||||||
| Cash and money market accounts | $ | $ | $ | $ | ||||||||||||
| Liabilities: | ||||||||||||||||
| Bank debt | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
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ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
(i) Concentration of Risk
Concentration of credit risk with respect to
accounts receivable is principally limited to certain customers to whom we make substantial sales. To reduce risk, we routinely assess
the financial strength of our customers and, as a consequence, believe that our accounts receivable credit risk exposure is limited. We
maintain an allowance for potential credit losses when deemed necessary, but historically we have not experienced significant credit losses
related to an individual customer or groups of customers in any particular industry or geographic area. Sales to significant customers
that amounted to
During the Three-Month Periods | During
the Six-Month Periods | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Company A | % | % | % | % | ||||||||||||
| Company B | % | % | % | % | ||||||||||||
| Company C | % | % | ||||||||||||||
| * |
Trade accounts receivable due from significant customers amounted to the percentages of total trade accounts receivable as detailed in the following table:
As of June 30, | As of December 31, | |||||||
| Company A | % | % | ||||||
| Company B | % | % | ||||||
| Company C | % | |||||||
| * |
(j) Revenue Recognition
We recognize revenue in accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers. ASC 606 is a single comprehensive model for companies to use in accounting for revenue arising from contracts with customers. The core principle is that we recognize the amount of revenue to which we expect to be entitled for the transfer of promised goods or services to customers when a customer obtains control of promised goods or services in an amount that reflects the consideration we expect to receive in exchange for those goods or services. In addition, the standard requires disclosure of the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. We conduct our business with customers through valid purchase orders or sales orders which are considered contracts and are not interdependent on one another. A performance obligation is a promise in a contract to transfer a distinct product to the customer. The transaction price is the amount of consideration we expect to receive under the arrangement. Revenue is measured based on consideration specified in a contract with a customer. The transaction price of a contract is allocated to each distinct performance obligation and recognized when or as the customer receives the benefit of the performance obligation. Product transaction prices on a purchase or sales order are discrete and stand-alone. We recognize revenue when we satisfy a performance obligation in a contract by transferring control over a product to a customer when product delivery occurs. Amounts due are typically paid approximately 30 days from the time control is transferred. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost in costs of goods sold. We do not bill for or collect sales tax because our sales are generally made to distributors and thus our sales to them are not subject to sales tax. We generally have experienced an immaterial amount of product returns. We have enhanced disclosures related to disaggregation of revenue sources and accounting policies prospectively as a result of adopting this standard. See Note 14.
(k) Expense Recognition
We do not incur costs in connection with product
sales to customers that are eligible for capitalization. Advertising costs are expensed when incurred, which is generally during the month
in which the advertisement is published. Advertising expenses amounted to $
9
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
(l) Income Taxes
We account for income taxes in accordance with Codification Topic 740, Income Taxes, which requires that we recognize a current tax liability or asset for current taxes payable or refundable and a deferred tax liability or asset for the estimated future tax effects of temporary differences and carryforwards to the extent they are realizable. We consider future taxable income and feasible tax planning strategies in assessing the need for a valuation allowance against our deferred tax assets at the end of each quarter. If we determine that we would be able to realize our deferred tax assets in the future in excess of the net recorded amount over a reasonably short period of time, a reduction of the valuation allowance would increase income in the period such determination was made. Likewise, if we determine that we would not be able to realize all or part of our net deferred tax asset in the future, an increase to the valuation allowance would be charged to income in the period such determination was made.
Codification Topic 740-10 clarifies the accounting for income taxes by prescribing a minimum recognition threshold that a tax position must meet before being recognized in the financial statements. In the ordinary course of business, there are transactions and calculations where the ultimate tax outcome is uncertain. In addition, we are subject to periodic audits and examinations by the Internal Revenue Service and other taxing authorities. With few exceptions, we are no longer subject to income tax examinations by tax authorities for years before 2018. We have evaluated the positions taken on our filed tax returns and have concluded that no uncertain tax positions existed as of June 30, 2022 or December 31, 2021. Although we believe that our estimates are reasonable, actual results could differ from these estimates. See Note 16.
(m) Stock-Based Compensation
We account for stock-based compensation in accordance
with Codification Topic 718, Compensation-Stock Compensation, which generally requires us to recognize non-cash compensation expense
for stock-based payments using the fair-value-based method. The fair value of each stock option grant has been estimated on the date of
grant using the Black-Scholes option pricing model. Accordingly, we recorded compensation expense pertaining to stock-based compensation
of $
(n) Net Income (Loss) Per Common Share
Net income (loss) per common share has been computed
in accordance with Codification Topic 260-10, Earnings Per Share. The basic net income per share has been computed by dividing
net income by the weighted average number of common shares outstanding during the period. The diluted net income per share has been computed
by dividing net income by the weighted average number of shares outstanding during the period, plus all outstanding stock options with
an exercise price that is less than the average market price of the common stock during the period, less the number of shares that could
have been repurchased at this average market price, with the proceeds from the hypothetical stock option exercises and proceeds from unrecognized
compensation. The net (loss) per share has been computed by dividing the net (loss) by the weighted average number of common shares outstanding
during the period. All stock options have been excluded from the denominator in the calculation of dilutive earnings per share when we
are in a loss position because their inclusion would be anti-dilutive. Outstanding stock options that were not included in this calculation
because the effect would be anti-dilutive amounted to
During the Three-Month Periods | During
the Six-Month Periods | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Net (loss) income attributable to stockholders | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
| Weighted average common shares outstanding - Basic | ||||||||||||||||
| Dilutive impact of share-based compensation awards | ||||||||||||||||
| Weighted average common shares outstanding - Diluted | ||||||||||||||||
| Net (loss) income per share: | ||||||||||||||||
| Basic | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
| Diluted | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
10
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
(o) Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Although we regularly assess these estimates, actual amounts could differ from those estimates and are subject to change in the near term. Changes in estimates are recorded during the period in which they become known. Significant estimates include our inventory valuation, valuation of goodwill and long-lived assets, valuation of deferred tax assets, accrued expenses, costs of goods sold and useful lives of intangible assets.
(p) Accounting Pronouncements Recently Adopted
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The new guidance is intended to simplify the accounting for income taxes by removing certain exceptions and by updating accounting requirements around goodwill recognized for tax purposes and the allocation of current and deferred tax expense among legal entities, among other minor changes. ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. Early adoption was permitted. The adoption of ASU 2019-12 did not have a material impact on our financial statements as of January 1, 2021.
In March 2020, the FASB issued ASU 2020-04, Facilitation of the Effects of Reference Rate Reform on Financial Reporting. ASU 2020-04 is intended to provide optional expedients and exceptions to the U.S. GAAP guidance on contract modifications and hedge accounting to ease the financial reporting burdens related to the discontinuation of the London Interbank Offered Rate (LIBOR) or by another reference rate expected to be discontinued. The relief offered by this guidance, if adopted, is available to companies for the period March 12, 2020 through December 31, 2022. The discontinuation of LIBOR did not have a material impact on our financial statements as of January 1, 2021.
3. CASH AND CASH EQUIVALENTS
Cash and cash equivalents amounted to $
4. TRADE ACCOUNTS RECEIVABLE, net
Trade accounts receivable amounted to $
5. INVENTORY
Inventory consisted of the following:
| As of June 30, 2022 | As of December 31, 2021 | |||||||
| Raw materials | $ | $ | ||||||
| Work-in-process | ||||||||
| Finished goods | ||||||||
| Total | $ | $ | ||||||
6. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets consisted of the following:
| As of June 30, 2022 | As of December 31, 2021 | |||||||
| Prepaid expenses | $ | $ | ||||||
| Other receivables | ||||||||
| Total | $ | $ | ||||||
11
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
7. PROPERTY, PLANT AND EQUIPMENT, net
Property, plant and equipment consisted of the following:
| Estimated Useful Lives (in years) | As of June 30, 2022 | As of December 31, 2021 | ||||||||
| Laboratory and manufacturing equipment | $ | $ | ||||||||
| Buildings and improvements | ||||||||||
| Office furniture and equipment | ||||||||||
| Construction in progress | n/a | |||||||||
| Land | n/a | |||||||||
| Property, plant and equipment, gross | ||||||||||
| Accumulated depreciation | ( | ) | ( | ) | ||||||
| Property, plant and equipment, net | $ | $ | ||||||||
As of June 30, 2022 and December 31, 2021, construction
in progress consisted principally of payments toward the First Defense® production capacity expansion project and
equipment needed to bring the formulation and aseptic filling for Re-Tain® in-house. Property, plant and equipment
disposals were $
8. INTANGIBLE ASSETS
Intangible assets of $
Intangible assets as of June 30, 2022 consisted of the following:
| Gross Carrying Value | Accumulated Amortization | Net Book Value | ||||||||||
| Developed technology | $ | $ | ( | ) | $ | |||||||
| Customer relationships | ( | ) | ||||||||||
| Non-compete agreements | ( | ) | ||||||||||
| Total | $ | $ | ( | ) | $ | |||||||
Intangible assets as of December 31, 2021 consisted of the following:
| Gross Carrying Value | Accumulated Amortization | Net Book Value | ||||||||||
| Developed technology | $ | $ | ( | ) | $ | |||||||
| Customer relationships | ( | ) | ||||||||||
| Non-compete agreements | ( | ) | ||||||||||
| Total | $ | $ | ( | ) | $ | |||||||
9. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consisted of the following:
| As of June 30, 2022 | As of December 31, 2021 | |||||||
| Accounts payable – trade | $ | $ | ||||||
| Accounts payable – capital | ||||||||
| Accrued payroll | ||||||||
| Accrued professional fees | ||||||||
| Accrued other | ||||||||
| Income tax payable | ||||||||
| Total | $ | $ | ||||||
12
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
10. BANK DEBT
During the first quarter of 2020, we closed on a
debt financing with Gorham Savings Bank (GSB) aggregating $
During the second quarter of 2020, we received a
loan from the Maine Technology Institute (MTI) (Loan #3) in the aggregate principal amount of $
Debt proceeds received and principal repayments made during the three-month periods ended June 30, 2022 and 2021 are reflected in the following table by period and by loan:
| During the Three-Month Period Ended June 30, 2022 | During the Three-Month Period | |||||||||||||||
| Proceeds from Debt Issuance | Debt Principal Repayments | Proceeds from Debt Issuance | Debt Principal Repayments | |||||||||||||
| Loan #1 | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
| Loan #2 | ( | ) | ( | ) | ||||||||||||
| Loan #3 | ||||||||||||||||
| Loan #4 | ( | ) | ( | ) | ||||||||||||
| Loan #5 | ||||||||||||||||
| Total | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
13
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
Debt proceeds received and principal repayments made during the six-month periods ended June 30, 2022 and 2021 are reflected in the following table by period and by loan:
During the Six-Month Period | During
the Six-Month Period | |||||||||||||||
| Proceeds from Debt Issuance | Debt Principal Repayments | Proceeds from Debt Issuance | Debt Principal Repayments | |||||||||||||
| Loan #1 | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
| Loan #2 | ( | ) | ( | ) | ||||||||||||
| Loan #3 | ||||||||||||||||
| Loan #4 | ( | ) | ( | ) | ||||||||||||
| Loan #5 | ||||||||||||||||
| Total | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
Principal payments (net of debt issue costs)
due under bank loans outstanding as of June 30, 2022 (excluding our $
| During the Six-Month Period Ending December 31, | During the Years Ending December 31, | |||||||||||||||||||||||||||
| 2022 | 2023 | 2024 | 2025 | 2026 | Thereafter | Total | ||||||||||||||||||||||
| Loan #1 | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||
| Loan #2 | ||||||||||||||||||||||||||||
| Loan #3 | ||||||||||||||||||||||||||||
| Loan #4 | ||||||||||||||||||||||||||||
| Loan #5 | ||||||||||||||||||||||||||||
| Subtotal | ||||||||||||||||||||||||||||
| Debt issuance costs | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||
| Total | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||
11. CONTINGENT LIABILITIES AND COMMITMENTS
Our bylaws, as amended, in effect provide that the Company will indemnify its officers and directors to the maximum extent permitted by Delaware law. In addition, we make similar indemnity undertakings to each director through a separate indemnification agreement with that director. The maximum payment that we may be required to make under such provisions is theoretically unlimited and is impossible to determine. We maintain directors’ and officers’ liability insurance, which may provide reimbursement to the Company for payments made to, or on behalf of, officers and directors pursuant to the indemnification provisions. Our indemnification obligations were grandfathered under the provisions of Codification Topic 460, Guarantees. Accordingly, we have recorded no liability for such obligations as of June 30, 2022. Since our incorporation, we have had no occasion to make any indemnification payment to any of our officers or directors for any reason.
The development, manufacturing and marketing of animal health care products entails an inherent risk that liability claims will be asserted against us during the normal course of business. We are aware of no such claims against us as of the date of this filing. We feel that we have reasonable levels of liability insurance to support our operations.
We enter into agreements with third parties in the ordinary course of business under which we are obligated to indemnify such third parties from and against various risks and losses. The precise terms of such indemnities vary with the nature of the agreement. In many cases, we limit the maximum amount of our indemnification obligations, but in some cases those obligations may be theoretically unlimited. We have not incurred material expenses in discharging any of these indemnification obligations and based on our analysis of the nature of the risks involved, we believe that the fair value of the liabilities potentially arising under these agreements is minimal. Accordingly, we have recorded no liabilities for such obligations as of June 30, 2022.
We plan to purchase certain key parts (syringes) and services (formulation, aseptic filling and final packaging of Drug Product) pertaining to Re-Tain®, our Nisin-based intramammary treatment of subclinical mastitis in lactating dairy cows, exclusively from contractors. We are investing in the necessary equipment to perform the Drug Product formulation and aseptic filling services in-house.
14
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
In addition to the commitments discussed above,
we had committed $
12. OPERATING LEASE
On September 12, 2019,
The following tables describe our lease costs and other lease information.
During the Three-Month Periods | During
the Six-Month Periods | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Lease Cost | ||||||||||||||||
| Operating lease cost | $ | $ | $ | $ | ||||||||||||
| Variable lease cost | ||||||||||||||||
| Total lease cost | $ | $ | $ | $ | ||||||||||||
| Operating Lease | ||||||||||||||||
| Weighted average remaining lease term (in years) | ||||||||||||||||
| Weighted average discount rate | % | % | % | % | ||||||||||||
15
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
Future lease payments required under non-cancelable operating leases in effect as of June 30, 2022 were as follows:
| Amount | ||||
| During the six-month period ending December 31, 2022 | $ | |||
| During the Years Ending December 31, | ||||
| 2023 | ||||
| 2024 | ||||
| 2025 | ||||
| 2026 | ||||
| 2027 | ||||
| Thereafter | ||||
| Total lease payments (undiscounted cash flows) | ||||
| Less: imputed interest (discount effect of cash flows) | ( | ) | ||
| Total operating liabilities | $ | |||
13. STOCKHOLDERS’ EQUITY
Common Stock Issuances
From February 2016 to April 2021, we sold the
aggregate of
1) On February 3, 2016, we sold
2) On October 21, 2016, we sold, in a private placement,
3) On July 27, 2017, we sold
4) On December 21, 2017, we sold
5) On March 29, 2019, we sold
6) On April 14, 2021, we sold
16
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
Stock Option Plans
In June 2010, our stockholders approved the 2010
Stock Option and Incentive Plan (the “2010 Plan”) pursuant to the provisions of the Internal Revenue Code of 1986, under which
employees and certain service providers may be granted options to purchase shares of the Company’s common stock at no less than
fair market value on the date of grant. At that time,
Activity under the stock option plans described above was as follows:
| 2010 Plan | 2017 Plan | Weighted Average Exercise Price | Aggregate Intrinsic Value(1) | |||||||||||||
| Outstanding as of December 31, 2020 | $ | $ | ( | ) | ||||||||||||
| Grants | $ | |||||||||||||||
| Terminations/forfeitures | ( | ) | ( | ) | $ | |||||||||||
| Exercises | ( | ) | ( | ) | $ | |||||||||||
| Outstanding as of December 31, 2021 | $ | $ | ||||||||||||||
| Grants | $ | |||||||||||||||
| Terminations/forfeitures | ( | ) | ( | ) | $ | |||||||||||
| Exercises | ( | ) | $ | |||||||||||||
| Outstanding as of June 30, 2022 | $ | $ | ||||||||||||||
| Vested as of June 30, 2022 | $ | $ | ||||||||||||||
| Vested and expected to vest as of June 30, 2022 | $ | $ | ||||||||||||||
| Reserved for future grants | ||||||||||||||||
| (1) |
The following table displays additional information about the stock option plans described above:
| Number of Shares | Weighted Average Fair Value at Grant Date | Weighted Average Exercise Price | ||||||||||
| Non-vested stock options as of January 1, 2022 | $ | $ | ||||||||||
| Non-vested stock options as of June 30, 2022 | $ | $ | ||||||||||
| Stock options granted during the six-month period ended June 30, 2022 | $ | $ | ||||||||||
| Stock options that vested during the six-month period ended June 30, 2022 | $ | $ | ||||||||||
| Stock options that were forfeited during the six-month period ended June 30, 2022 | $ | $ | ||||||||||
During the six-month period ended June 30, 2022,
one former employee and two employees exercised stock options covering
17
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
The weighted average remaining life of the options
outstanding under the 2010 Plan and the 2017 Plan as of June 30, 2022 was approximately
During the Three-Month Periods | During the Six-Month Periods | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Risk-free interest rate | % | % | % | % | ||||||||||||
| Dividend yield | % | % | % | % | ||||||||||||
| Expected volatility | % | % | % | % | ||||||||||||
| Expected life | ||||||||||||||||
The risk-free interest rate is based on U.S. Treasury yields for a maturity approximating the expected option term, while the other assumptions are derived from averages of our historical data.
Common Stock Rights Plan
In September 1995, our Board of Directors adopted
a Common Stock Rights Plan (the “Rights Plan”) and declared a dividend of one common share purchase right (a “Right”)
for each of the then outstanding shares of the common stock of the Company. Each Right entitles the registered holder to purchase from
the Company one share of common stock at an initial purchase price of $
The Rights (as amended) become exercisable and transferable apart from the common stock upon the earlier of i) 10 days following a public announcement that a person or group (Acquiring Person) has, without the prior consent of the Continuing Directors (as such term is defined in the Rights Agreement), acquired beneficial ownership of 20% or more of the outstanding common stock or ii) 10 days following commencement of a tender offer or exchange offer the consummation of which would result in ownership by a person or group of 20% or more of the outstanding common stock (the earlier of such dates being called the Distribution Date).
Upon the Distribution Date,
At any time after a person or group becomes an Acquiring Person and prior to the acquisition by such person or group of 50% or more of the outstanding common stock, the Board of Directors of the Company may exchange the Rights (other than Rights owned by such person or group which have become void), in whole or in part, at an exchange ratio of one share of common stock per Right (subject to adjustment). At any time prior to 14 days following the date that any person or group becomes an Acquiring Person (subject to extension by the Board of Directors), the Board of Directors of the Company may redeem the then outstanding Rights in whole, but not in part, at a price of $0.005 per Right, subject to adjustment.
At various times over the years, our Board of
Directors has voted to authorize amendments of the Rights Plan to extend the Final Expiration Date.
18
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
Authorized Common Stock
At the June 14, 2018 Annual Meeting of Stockholders,
our stockholders voted to approve an amendment to our Certificate of Incorporation to increase the number of shares of common stock authorized
for issuance from
14. REVENUE
We primarily offer the First DefenseÒ product line to dairy and beef producers to prevent scours in newborn calves. Generally, our products are promoted to veterinarians as well as dairy and beef producers by our sales team and then sold through distributors. Our primary market is North America. We do sell into select international regions and may expand this international reach in the future. There were no material changes between the allocation and timing of revenue recognition during the six-month period ended June 30, 2022 or the year ended December 31, 2021. We do not have any contract assets for which we have satisfied the performance obligations, but do not yet have the right to bill for, or contract liabilities such as customer advances. All trade receivables on our balance sheets are from contracts with customers. We incur no material costs to obtain contracts.
The following tables present our product sales disaggregated by geographic area:
| During the Three-Month Periods Ended June 30, | During the Six-Month Periods Ended June 30, | |||||||||||||||||||||||||||||||
| 2022 | % | 2021 | % | 2022 | % | 2021 | % | |||||||||||||||||||||||||
| United States | $ | % | $ | % | $ | % | $ | % | ||||||||||||||||||||||||
| Other | % | % | % | % | ||||||||||||||||||||||||||||
| Total Product Sales | $ | % | $ | % | $ | % | $ | % | ||||||||||||||||||||||||
The following tables present our product sales disaggregated by major product category:
| During the Three-Month Periods Ended June 30, | During the Six-Month Periods Ended June 30, | |||||||||||||||||||||||||||||||
| 2022 | % | 2021 | % | 2022 | % | 2021 | % | |||||||||||||||||||||||||
| First Defense® product line | $ | % | $ | % | $ | % | $ | % | ||||||||||||||||||||||||
| Other animal health | % | % | % | % | ||||||||||||||||||||||||||||
| Total Product Sales | $ | % | $ | % | $ | % | $ | % | ||||||||||||||||||||||||
The following tables present our product sales disaggregated by geographic area:
| During the Years Ended December 31, | ||||||||||||||||
| 2021 | % | 2020 | % | |||||||||||||
| United States | $ | % | $ | % | ||||||||||||
| Other | % | % | ||||||||||||||
| Total Product Sales | $ | % | $ | % | ||||||||||||
The following tables present our product sales disaggregated by major product category:
| During the Years Ended December 31, | ||||||||||||||||
| 2021 | % | 2020 | % | |||||||||||||
| First Defense® product line | $ | % | $ | % | ||||||||||||
| Other animal health | % | % | ||||||||||||||
| Total Product Sales | $ | % | $ | % | ||||||||||||
19
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
15. OTHER EXPENSES, NET
Other expenses (income), net, consisted of the following:
During the Three-Month Periods | During the Six-Month Periods | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Interest expense(1) | $ | $ | $ | $ | ||||||||||||
| Gain on disposal of fixed assets | ( | ) | ( | ) | ||||||||||||
| Interest income | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income - other | ( | ) | ( | ) | — | |||||||||||
| Other expenses (income), net | $ | $ | $ | $ | ||||||||||||
| (1) |
16. INCOME TAXES
Our income tax expense aggregated $
The provision for income taxes is determined using
the asset and liability approach of accounting for income taxes. Under this approach, deferred taxes represent the estimated future tax
effects of temporary differences between book and tax treatment of assets and liabilities and carryforwards to the extent they are realizable.
During the second quarter of 2018, we assessed our historical and near-term future profitability and recorded $
Net operating loss carryforwards, credits, and other tax attributes are subject to review and possible adjustment by the Internal Revenue Service. Section 382 of the Internal Revenue Code contains provisions that could place annual limitations on the future utilization of net operating loss carryforwards and credits in the event of a change in ownership of the Company, as defined.
We file income tax returns in the U.S. federal jurisdiction and several state jurisdictions. We currently have no tax examinations in progress. We also have not paid additional taxes, interest or penalties as a result of tax examinations nor do we have any unrecognized tax benefits for any of the periods in the accompanying unaudited financial statements.
20
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
17. SEGMENT INFORMATION
Our business operations (being the development, acquisition, manufacture and sale of products that improve the health and productivity of dairy and beef cattle) are described in Note 1. Pursuant to Codification Topic 280, Segment Reporting, we operate in the following two reportable business segments: i) Scours and ii) Mastitis. The Scours segment consists of the First Defense® product line. The Mastitis segment includes our products, CMT and Re-Tain®. The category we define as “Other” includes unallocated administrative and overhead expenses and other products. The significant accounting policies of these segments are described in Note 2. Product sales are the primary factor we use in determining our reportable segments. The governing regulatory authority (USDA for First Defense® or FDA for Re-Tain®) is also a factor in determining our reportable segments. Management monitors and evaluates segment performance from sales to net operating income (loss) closely. We are not organized by geographic region. No segments have been aggregated. The revenues and expenses allocated to each segment are in some cases direct and in other cases involve reasonable and consistent estimations by management. Each operating segment is defined as the component of our business for which financial information is available and evaluated regularly by our chief operating decision-maker in deciding how to allocate resources and in assessing performance. Our chief operating decision-maker is our President and CEO.
| During the Three-Month Period Ended June 30, 2022 | ||||||||||||||||
| Scours | Mastitis | Other | Total | |||||||||||||
| Product sales | $ | $ | $ | $ | ||||||||||||
| Costs of goods sold | ||||||||||||||||
| Gross margin | ( | ) | ||||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Product development expenses | ||||||||||||||||
| Sales and marketing expenses | ||||||||||||||||
| Administrative expenses | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| NET OPERATING INCOME (LOSS) | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||
| During the Three-Month Period Ended June 30, 2021 | ||||||||||||||||
| Scours | Mastitis | Other | Total | |||||||||||||
| Product sales | $ | $ | $ | $ | ||||||||||||
| Costs of goods sold | ||||||||||||||||
| Gross margin | ||||||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Product development expenses | ||||||||||||||||
| Sales and marketing expenses | ||||||||||||||||
| Administrative expenses | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| NET OPERATING INCOME (LOSS) | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||
| Scours | Mastitis | Total | ||||||||||
| Total Assets as of June 30, 2022 | $ | $ | $ | |||||||||
| Total Assets as of June 30, 2021 | $ | $ | $ | |||||||||
| Depreciation and amortization expense during the three-month period ended June 30, 2022 | $ | $ | $ | |||||||||
| Depreciation and amortization expense during the three-month period ended June 30, 2021 | $ | $ | $ | |||||||||
| Capital Expenditures during the three-month period ended June 30, 2022 | $ | $ | $ | |||||||||
| Capital Expenditures during the three-month period ended June 30, 2021 | $ | $ | $ | |||||||||
21
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
| During the Six-Month Period Ended June 30, 2022 | ||||||||||||||||
| Scours | Mastitis | Other | Total | |||||||||||||
| Product sales | $ | $ | $ | $ | ||||||||||||
| Costs of goods sold | ||||||||||||||||
| Gross margin | ( | ) | ||||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Product development expenses | ||||||||||||||||
| Sales and marketing expenses | ||||||||||||||||
| Administrative expenses | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| NET OPERATING INCOME (LOSS) | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||
| During the Six-Month Period Ended June 30, 2021 | ||||||||||||||||
| Scours | Mastitis | Other | Total | |||||||||||||
| Product sales | $ | $ | $ | $ | ||||||||||||
| Costs of goods sold | ||||||||||||||||
| Gross margin | ||||||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Product development expenses | ||||||||||||||||
| Sales and marketing expenses | ||||||||||||||||
| Administrative expenses | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| NET OPERATING INCOME (LOSS) | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||
| Scours | Mastitis | Total | ||||||||||
| Total Assets as of June 30, 2022 | $ | $ | $ | |||||||||
| Total Assets as of June 30, 2021 | $ | $ | $ | |||||||||
| Depreciation and amortization expense during the six-month period ended June 30, 2022 | $ | $ | $ | |||||||||
| Depreciation and amortization expense during the six-month period ended June 30, 2021 | $ | $ | $ | |||||||||
| Capital Expenditures during the six-month period ended June 30, 2022 | $ | $ | $ | |||||||||
| Capital Expenditures during the six-month period ended June 30, 2021 | $ | $ | $ | |||||||||
22
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
| During the Year Ended December 31, 2021 | ||||||||||||||||
| Scours | Mastitis | Other | Total | |||||||||||||
| Product sales | $ | $ | $ | $ | ||||||||||||
| Costs of goods sold | ||||||||||||||||
| Gross margin | ||||||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Product development expenses | ||||||||||||||||
| Sales and marketing expenses | ||||||||||||||||
| Administrative expenses | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| NET OPERATING INCOME (LOSS) | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||
| During the Year Ended December 31, 2020 | ||||||||||||||||
| Scours | Mastitis | Other | Total | |||||||||||||
| Product sales | $ | $ | $ | $ | ||||||||||||
| Costs of goods sold | ||||||||||||||||
| Gross margin | ||||||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Product development expenses | ||||||||||||||||
| Sales and marketing expenses | ||||||||||||||||
| Administrative expenses | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| NET OPERATING INCOME (LOSS) | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||
| Scours | Mastitis | Total | ||||||||||
| Total Assets as of December 31, 2021 | $ | $ | $ | |||||||||
| Total Assets as of December 31, 2020 | $ | $ | $ | |||||||||
| Depreciation and amortization expense during the year ended December 31, 2021 | $ | $ | $ | |||||||||
| Depreciation and amortization expense during the year ended December 31, 2020 | $ | $ | $ | |||||||||
| Capital Expenditures during the year ended December 31, 2021 | $ | $ | $ | |||||||||
| Capital Expenditures during the year ended December 31, 2020 | $ | $ | $ | |||||||||
23
ImmuCell Corporation
Notes to Unaudited Financial Statements
(continued)
18. RELATED PARTY TRANSACTIONS
Dr.
David S. Tomsche (Chair of our Board of Directors) is a controlling owner of Leedstone Inc., a domestic distributor of ImmuCell products
(the First DefenseÒ product
line and CMT), and of J-t Enterprises of Melrose, Inc., an exporter. His affiliated companies purchased $
19. EMPLOYEE BENEFITS
20. SUBSEQUENT EVENTS
We have evaluated subsequent events through the time of filing on August 11, 2022, the date we have issued this Quarterly Report on Form 10-Q. As of the time of filing on August 11, 2022, there were no material, reportable subsequent events.
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ImmuCell Corporation
ITEM 2 - MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited financial statements and the related notes and other financial information included in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. One should review the Cautionary Note below for a discussion of some of the important factors that could cause actual results to differ materially from the results, objectives or expectations described in or implied by the forward-looking statements contained in the following discussion and analysis.
Cautionary Note Regarding Forward-Looking Statements (Safe Harbor Statement):
This Quarterly Report on Form 10-Q 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 not limited to, any statements relating to: our plans and strategies for our business; projections of future financial or operational performance; the timing and outcome of pending or anticipated applications for regulatory approvals; factors that may affect the dairy and beef industries and future demand for our products; the extent, nature and duration of the COVID-19 pandemic and its consequences, and their direct and indirect impacts on our production activities, operating results and financial condition and on the customers and markets that we serve; the impact of Russia’s unprovoked military invasion of Ukraine and attack on its people on the world economy including inflation and the price and availability of grain and oil; the impact of the global supply-chain disruptions on our ability to obtain, in a timely and cost-effective fashion, all the supplies and components we need to produce our products; the challenges in attracting and retaining needed personnel in this current employment environment; the impact of inflation and rising interest rates on our operating expenses and financial results; the effects of a potential United States or global recession on us and our direct and indirect customers, the duration and severity of which are difficult to predict or anticipate; the scope and timing of ongoing and future product development work and commercialization of our products; future costs of product development efforts; the estimated prevalence rate of subclinical mastitis and producers’ level of interest in treating subclinical mastitis given the current economic and market conditions; the expected efficacy of new products; estimates about the market size for our products; future market share of and revenue generated by current products and products still in development; our ability to increase production output and reduce costs of goods sold per unit; the future adequacy of our own manufacturing facilities or those of third parties with which we have contractual relationships to meet demand for our products on a timely basis; the impacts of backlogs on customer relationships; the anticipated costs of (or time to complete) planned expansions of our manufacturing facilities and the adequacy of our funds available for these projects; the continuing availability to us on reasonable terms of third-party providers of critical products or services; the robustness of our manufacturing processes and related technical issues; estimates about our production capacity, efficiency and yield, which are highly subject to biological variability and the product format mix of our sales; the future adequacy of our working capital and the availability and cost of third-party financing; future regulatory requirements relating to our products; future expense ratios and margins; future compliance with bank debt covenants; costs associated with sustaining compliance with current Good Manufacturing Practice (cGMP) regulations in our current operations and attaining such compliance for our facilities to produce the Nisin Drug Substance and Drug Product; our effectiveness in competing against competitors within both our existing and our anticipated product markets; the cost-effectiveness of additional sales and marketing expenditures and resources; anticipated changes in our manufacturing capabilities and efficiencies; the value of our net deferred tax assets; projections about depreciation expense and its impact on income for book and tax return purposes; and any other statements that are not historical facts. Forward-looking statements can be identified by the use of words such as “expects”, “may”, “anticipates”, “aims”, “intends”, “would”, “could”, “should”, “will”, “plans”, “believes”, “estimates”, “targets”, “projects”, “forecasts”, “seeks” and similar words and expressions. In addition, there can be no assurance that future developments affecting us will be those that we anticipate. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to: difficulties or delays in development, testing, regulatory approval, production and marketing of our products (including the First Defense® product line and Re-Tain®), competition within our anticipated product markets, customer acceptance of our new and existing products, product performance, alignment between our manufacturing resources and product demand (including the consequences of backlogs or excess inventory buildup), uncertainty associated with the timing and volume of customer orders as we come out of a prolonged backlog, adverse impacts of supply chain disruptions on our operations and customer relationships, our reliance upon third parties for financial support, products and services, our small size and dependence on key personnel, changes in laws and regulations, decision making and delays by regulatory authorities, a continuation or worsening of recent inflationary conditions and their impact on our customers’ order patterns, uncertainty and possible adverse effects on us and our customers arising from an economic recession, currency values and fluctuations and other risks detailed from time to time in filings we make with the Securities and Exchange Commission (SEC), including our Quarterly Reports on Form 10-Q, our Annual Reports on Form 10-K and our Current Reports on Form 8-K. Such statements involve risks and uncertainties and are based on our current expectations, but actual results may differ materially due to various factors, including the risk factors summarized under PART II: ITEM 1A – RISK FACTORS and uncertainties otherwise referred to in this Quarterly Report on Form 10-Q.
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ImmuCell Corporation
Liquidity and Capital Resources
Net cash provided by operating activities was $1 million during six-month period ended June 30, 2022 in comparison to net cash provided by operating activities of $107,000 during the six-month period ended June 30, 2021. The $905,000 increase in cash provided by operating activities from period to period was largely the net result of a $352,000 swing from a net loss to net income plus $1.5 million in cash generated from the collection of accounts receivable being offset by $1.2 million more cash being invested in inventory. As we increased our production capacity to fill the backlog of orders, our inventory balance increased from $3.1 million as of December 31, 2021 to $4.6 million as of June 30, 2022. Our total depreciation expense was approximately $1.2 million during both of the six-month periods ended June 30, 2022 and 2021. We anticipate that depreciation expense, while not affecting our cash flows from operations, will be a significant factor in creating annual net operating losses until and unless product sales increase sufficiently to offset these non-cash expenses. Cash (used for) investing activities was ($1.7 million) during the six-month period ended June 30, 2022 in comparison to cash (used for) investing activities of ($223,000) during the six-month period ended June 30, 2021. Cash paid for capital expenditures was $1.8 million and $1.2 million during the six-month periods ended June 30, 2022 and 2021, respectively, which payments were largely related to our ongoing investments to expand our manufacturing facilities. Cash provided by financing activities decreased to $1.6 million during the six-month period ended June 30, 2022 in comparison to cash provided by financing activities of $3.9 million during the six-month period ended June 30, 2021. Going forward, repayments of the indebtedness incurred to fund these capital expenditures and acquire these assets will reduce our cash flows.
From the first quarter of 2016 through the second quarter of 2021, we raised gross proceeds of approximately $26.7 million (net proceeds were approximately $24.8 million) from six different common equity transactions priced between $5.25 and $8.25 per share with a weighted average price of approximately $5.87 per share. No warrants were issued in connection with any of these transactions, and no convertible or preferred securities were issued. This capital, together with our bank debt and gross margin from product sales, has allowed us to transform the Company. We are (and have been) investing significantly to increase our capacity to produce the First Defense® product line from $16.5 million to over $40 million per year. The actual value of our production capacity varies based on biological and process yields, product format mix, selling price and other factors. At the same time, we are simply asking the FDA if we may have authorization to sell Re-Tain® into the dairy market.
As a result of several bank debt refinancings and amendments with, and scheduled principal repayments to, Gorham Savings Bank (GSB) since the first quarter of 2020, we had $10.7 million in outstanding bank debt as of June 30, 2022, compared to $9.1 million as of June 30, 2021. We have improved our liquidity by lowering our interest expense, spreading our principal payments out over a longer period of time and pushing out balloon principal payment obligations that existed under some of the repaid debt. Also, because all of this debt bears interest at fixed rates, we are avoiding the potential adverse effects of rising interest rates on our debt service costs. Debt principal repayments aggregated $813,000 and $1.3 million during the twelve-month periods ended June 30, 2022 and 2021, respectively. The higher debt repayments during the twelve-month period ended June 30, 2021 reflect our decision to prepay approximately $624,000 of our then outstanding mortgage debt to remove a restricted cash bank debt covenant during December 2020. We anticipate that debt principal repayments will aggregate approximately $907,000 during the twelve-month period ending June 30, 2023, exclusive of any consideration given to the two loans from the Maine Technology Institute (MTI) discussed below. Interest expense was $313,000 and $306,000 during the twelve-month periods ended June 30, 2022 and 2021, respectively. We anticipate that interest expense will be $337,000 during the twelve-month period ending June 30, 2023, exclusive of any consideration given to the two loans from the MTI discussed below. During the first quarter of 2022, the availability of our $1.0 million line of credit, which bears interest at the National Prime Rate plus 0.00% per annum, was extended until March 11, 2024. These credit facilities are secured by substantially all of our assets, including our facility at 56 Evergreen Drive in Portland (which was independently appraised at $6.3 million in connection with a 2022 financing, at $3 million in connection with a 2020 refinancing and at $4.2 million in connection with a 2015 financing) and our facility at 33 Caddie Lane in Portland (which was independently appraised at $3.2 million in connection with a 2017 financing and at $2.5 million in connection with a 2020 refinancing). These credit facilities are subject to certain restrictions and financial covenants. We are required to meet a minimum debt service coverage (DSC) ratio set by GSB of 1.35. Our actual DSC ratio was equal to 2.68, 2.03 and 1.57 during the years ended December 31, 2021, 2020 and 2019, respectively. However, based on current projections of our future financial performance, which includes a high level of ongoing product development expenses to support Re-Tain®, we may not satisfy this annual requirement for the year ending December 31, 2022. By negotiation with GSB in connection with a 2022 financing, the required minimum DSC ratio was reduced to 1.0 for the year ending December 31, 2022.
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ImmuCell Corporation
During June 2020, we received a $500,000 loan from the MTI. The first 2.25 years of this loan are interest-free with no interest accrual or required principal payments. Principal and interest payments at a fixed rate of 5% per annum are due quarterly over the final 5 years of the loan, beginning during the fourth quarter of 2022 and continuing through the third quarter of 2027. During July 2021, we received an additional $400,000 loan from the MTI. The first 2 years of this second loan are interest-free with no interest accrual or required principal payments. Principal and interest payments at a fixed rate of 5% per annum are due quarterly over the final 5.5 years of the loan, beginning during the third quarter of 2023 and continuing through the fourth quarter of 2028. Both loans are unsecured and subordinated to all other bank debt from GSB and may be repaid without penalty at any time. This support from the State of Maine through the MTI helps us move forward aggressively with our investments while increasing our total employee count.
We have funded most of our business operations principally from the gross margin on our product sales and from the equity and debt financings described above. Based on our best estimates and projections, we believe that our cash and cash equivalents, together with gross margin anticipated to be earned from ongoing product sales, will be sufficient to meet our currently planned working capital and capital expenditure requirements and to finance our ongoing business operations for at least 12 months (which is the period of time required to be addressed for such purposes by accounting disclosure standards) from the date of this filing. The table below summarizes the changes in selected, key accounts (in thousands, except for percentages):
| As of June 30, | As of December 31, | Increase | ||||||||||||||
| 2022 | 2021 | Amount | % | |||||||||||||
| Cash and cash equivalents | $ | 11,043 | $ | 10,185 | $ | 858 | 8 | % | ||||||||
| Net working capital | $ | 14,820 | $ | 13,730 | $ | 1,089 | 8 | % | ||||||||
| Total assets | $ | 45,984 | $ | 44,466 | $ | 1,518 | 3 | % | ||||||||
| Stockholders’ equity | $ | 32,775 | $ | 32,577 | $ | 198 | 1 | % | ||||||||
| Common shares outstanding(1) | 7,747 | 7,742 | 5 | 0 | % | |||||||||||
| (1) | There were approximately 548,000 and 443,000 shares of common stock reserved for issuance for stock options that were outstanding as of June 30, 2022 and December 31, 2021, respectively. |
From 2014 to 2019, we initiated four capital expenditure investments, as described in the following table (in thousands):
| Cash Paid on Projects Initiated Before 2021 During the | ||||||||||||||||||||
| A | B | C | D | Total | ||||||||||||||||
| Year Ended December 31, 2014 | $ | 1,041 | $ | — | $ | — | $ | — | $ | 1,041 | ||||||||||
| Year Ended December 31, 2015 | 1,991 | 265 | — | — | 2,256 | |||||||||||||||
| Year Ended December 31, 2016 | 1,173 | 2,093 | — | — | 3,266 | |||||||||||||||
| Year Ended December 31, 2017 | — | 17,686 | — | — | 17,686 | |||||||||||||||
| Year Ended December 31, 2018 | — | 1,596 | — | — | 1,596 | |||||||||||||||
| Year Ended December 31, 2019 | — | — | 279 | 538 | 817 | |||||||||||||||
| Year Ended December 31, 2020 | — | — | 2,938 | 581 | 3,519 | |||||||||||||||
| Year Ended December 31, 2021 | — | — | 432 | 886 | 1,318 | |||||||||||||||
| Six-Month Period Ended June 30, 2022 | — | — | 4 | 306 | 310 | |||||||||||||||
| Total Paid through June 30, 2022 | 4,205 | 21,640 | 3,653 | 2,311 | 31,809 | |||||||||||||||
| Estimate to Complete | — | — | — | 1,689 | 1,689 | |||||||||||||||
| Total Project Cost | $ | 4,205 | $ | 21,640 | $ | 3,653 | $ | 4,000 | $ | 33,498 | ||||||||||
PROJECT A included a 7,100 square foot facility addition at 56 Evergreen Drive and related equipment and cold storage capacity to increase the production capacity for the First Defense® product line. During the first quarter of 2016, we completed this investment, increasing our freeze drying capacity by 100% and making other improvements to our liquid processing capacity, which increased our annual production capacity (in terms of annual sales dollars) to approximately $16.5 million. The actual value of our production output varies based on biological and process yields, product format mix, selling price and other factors. This investment also included the construction and equipping of a pilot plant for small-scale Drug Substance production for Re-Tain® within our First Defense® production facility at 56 Evergreen Drive. After PROJECT B was completed, this space was converted for use in the production of the gel tube formats of the First Defense® product line. One of the objectives of PROJECT C was a relocation of these gel tube operations to 175 Industrial Way, vacating production space at 56 Evergreen Drive for use in doubling our liquid processing capacity.
PROJECT B was related to the Drug Substance production facility for Re-Tain® at 33 Caddie Lane. During the fourth quarter of 2017, we completed construction of the Drug Substance production facility. We began equipment installation during the third quarter of 2017, and we completed this installation during the third quarter of 2018. The total cost of this investment for the Drug Substance production facility and related processing equipment was $20.8 million plus $331,000 for the land and $472,000 for the acquisition of an adjacent 4,080 square foot warehouse facility, which will be used for cold storage of Re-Tain® inventory and other warehousing needs.
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ImmuCell Corporation
PROJECT C consisted of significant renovations to a 14,300 square foot leased facility at 175 Industrial Way, some facility modifications at 56 Evergreen Drive and the necessary production equipment to increase the annual production capacity of the First Defense® product line (in terms of annual sales dollars) from approximately $16.5 million to approximately $23 million. The actual value of our production output varies based on biological and process yields, product format mix, selling price and other factors. This expansion involved a 40% increase in our freeze drying capacity and a 100% increase in our liquid processing capacity. Renovations to our leased facility at 175 Industrial Way to enable this expansion were completed during the second quarter of 2020. By moving our powder filling and assembly services from 56 Evergreen Drive into this new space at 175 Industrial Way, we created space at 56 Evergreen Drive for the installation of the expanded freeze drying capacity. The new facilities are built to contemporary cGMP standards with good material and people flows. A site license approval for this new facility at 175 Industrial Way was issued by the USDA during the third quarter of 2020. During the second quarter of 2021, we completed the relocation of our gel formulation equipment from 56 Evergreen Drive to 175 Industrial Way, creating space for the doubling of our liquid processing capacity at 56 Evergreen Drive. We obtained site license approval of the expanded freeze drying capacity at 56 Evergreen Drive from the USDA during the third quarter of 2021, and we obtained temporary (subject to final USDA review and approval) site license approval of the expanded liquid processing capacity at 56 Evergreen Drive from the USDA during the first quarter of 2022. As part of this investment, we also made the facility modifications at 56 Evergreen Drive necessary to expand our freeze drying capacity by an additional 35%, which would increase our annual production capacity from approximately $23 million to approximately $30 million or more (together with the work involved in PROJECT F discussed below). The actual value of our production capacity varies based on biological and process yields, product format mix, selling price and other factors.
PROJECT D is a $4 million budgeted investment to bring the formulation and aseptic filling capabilities for Re-Tain® Drug Product in-house to end our reliance on third-party Drug Product manufacturing services. We began initial equipment installation during the first quarter of 2022. We anticipate FDA approval of this facility (which is a requirement for commercial manufacturing) by the second quarter of 2024.
During the second quarter of 2021, we initiated three more capital expenditure investments, and during the second quarter of 2022, we initiated one additional capital expenditure investment, as described in the following table (in thousands):
| Cash Paid on Projects Initiated During 2021 or after during the | ||||||||||||||||||||
| E | F | G | H | Total | ||||||||||||||||
| Year Ended December 31, 2021 | $ | 452 | $ | 296 | $ | 282 | $ | — | $ | 1,030 | ||||||||||
| Six-Month Period Ended June 30, 2022 | 152 | 552 | 421 | 1 | 1,126 | |||||||||||||||
| Total Paid through June 30, 2022 | 604 | 848 | 703 | 1 | 2,156 | |||||||||||||||
| Estimate to Complete | 146 | 112 | 2,137 | 1,699 | 4,094 | |||||||||||||||
| Total Project Cost | $ | 750 | $ | 960 | $ | 2,840 | $ | 1,700 | $ | 6,250 | ||||||||||
PROJECT E represents a $750,000 budget for equipment and vehicle investments necessary to expand and improve our colostrum collection capabilities and logistics.
PROJECT F represents a budget estimate of $960,000 for freeze drying equipment to expand on PROJECT C to further increase the annual production capacity of the First Defense® product line (in terms of annual sales dollars) from approximately $23 million to approximately $30 million or more by increasing our freeze drying capacity by an additional 35%. The actual value of our production capacity varies based on biological and process yields, product format mix, selling price and other factors. We initiated PROJECT F during the third quarter of 2021, and we anticipate completing this investment during the third quarter of 2022.
PROJECT G represents an increased budget estimate of $2,840,000 for equipment and facility modifications to scale-up and upgrade our vaccine manufacturing capacity, construct pack & ship facilities for Re-Tain®, improve our quality laboratories and install new equipment for our gel filling operations. We estimate that the investment in our gel filling equipment will increase our annual production capacity for the First Defense® product line (in terms of annual sales dollars) further from approximately $30 million to approximately $35 million by the end of 2022. The actual value of our production capacity varies based on biological and process yields, product format mix, selling price and other factors.
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ImmuCell Corporation
PROJECT H represents a new investment in building modifications and equipment to further increase our annual First Defense® production capacity from the $35 million level that we expect to reach by the end of 2022 to $42 million during 2024 with options for further expansion. The actual value of our production capacity varies based on biological and process yields, product format mix, selling price and other factors. We anticipate leasing a to-be-constructed 15,400 square foot building shell for approximately $250,000 per year, which operating cost is not included in the capital expenditure table above. We anticipate a lease commencement date (after the landlord completes construction of the building shell) around the beginning of 2023. We may make this lease commitment during the third quarter because of the unique proximity of the land adjacent to our currently leased space at 175 Industrial Way and the high level of demand for properties of this type in the Portland market. We did not want to risk losing this opportunity to others. The freeze drying equipment that would be critical to achieving this next level of production capacity expansion requires 18 to 24 months of lead time for fabrication, installation, qualification and implementation. In order to have this equipment operational by the beginning of 2024, we recently committed $1.7 million to its purchase. The $1.7 million listed in the capital expenditure table above is just the amount of funds committed to PROJECT H to date. This new leased space could house up to three additional similar equipment investments that we could consider if justified by market demand in the future. Over the next few months, we will evaluate our options and best strategy for this new space and develop the full cost estimates for the work required to modify the building shell to meet our needs optimally. We expect to define the scope and budget for PROJECT H more definitively by year end.
In addition to the specific projects listed above, our budget for routine and miscellaneous capital expenditures for the year ending December 31, 2022 is $825,000. We spent $321,000 of this budget during the first six months of 2022. These routine and miscellaneous capital expenditures amounted to $260,000, $554,000 and $574,000 during the years ended December 31, 2021, 2020 and 2019, respectively. The spend on this budget category during 2021 was lower than expected, and the spend during 2022 is anticipated to be higher than the historical norm.
We have set aside approximately $6.3 million of the $11 million of the cash we had on hand as of June 30, 2022 to complete PROJECT D to PROJECT G and to fund the initial $1.7 million towards PROJECT H, as well as to pay for our other routine and miscellaneous capital expenditures during the second half of 2022, leaving the remaining cash balance of approximately $4.8 million available for the completion of PROJECT H and for general working capital purposes (including anticipated inventory builds for both First Defense® and Re-Tain®).
During the third quarter of 2016, the City of Portland approved a Tax Increment Financing (TIF) credit enhancement package that reduces the real estate taxes on our Drug Substance production facility for Re-Tain® by 65% over the eleven-year period beginning on July 1, 2017 and ending June 30, 2028 and by 30% during the year ending June 30, 2029, at which time the rebate expires. During the second quarter of 2017, the TIF was approved by the Maine Department of Economic and Community Development. The value of the tax savings will increase (decrease) in proportion to any increases (decreases) in the assessment of the building for city real estate tax purposes or the City’s tax rate. The following table discloses how much of the new taxes we have generated is being relieved by the TIF and how much is being paid by ImmuCell:
| Assessed Value | Twelve-Month Period Ended | Total New Taxes Generated by the Project | Less: TIF Credit | Net Amount Paid by ImmuCell | ||||||||||
| $1.7 million @ April 1, 2017 | June 30, 2018 | $ | 36,000 | $ | 22,000 | $ | 13,000 | |||||||
| $4.0 million @ April 1, 2018 | June 30, 2019 | $ | 90,000 | $ | 58,000 | $ | 32,000 | |||||||
| $4.0 million @ April 1, 2019 | June 30, 2020 | $ | 94,000 | $ | 60,000 | $ | 34,000 | |||||||
| $4.0 million @ April 1, 2020 | June 30, 2021 | $ | 94,000 | $ | 60,000 | $ | 34,000 | |||||||
| $4.3 million @ April 1, 2021 | June 30, 2022 | $ | 55,000 | $ | 36,000 | $ | 20,000 | |||||||
Results of Operations
Business Segments
As detailed in Note 17, “Segment Information”, to the accompanying unaudited financial statements, we operate in two business segments. The Scours segment is dedicated to manufacturing and selling First Defense®, a product used to prevent scours in newborn calves, which is regulated by the USDA. The Mastitis segment is focused on developing and commercializing Re-Tain®, a product to treat subclinical mastitis in lactating dairy cows, which is regulated by the FDA.
Product Sales
Through both continued growth in sales of the First Defense® product line and a successful launch of Re-Tain® as soon as possible, and with a measured approach to expanding our customer-facing staff, it is our objective to increase our current annual level of total product sales of approximately $19.2 million for the year ended December 31, 2021 to approximately $23 million or more by the year ending December 31, 2023. As additional resources are dedicated to production, sales, marketing and technical services, our longer-term goal is to exceed $35 million of annual total product sales as soon as possible during the five-year period after the market launch of Re-Tain®.
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ImmuCell Corporation
Sales decreased by 15%, or $680,000, to $3.9 million during the three-month period ended June 30, 2022, in comparison to the three-month period ended June 30, 2021. Domestic sales decreased by 12%, and international sales decreased by 41%, in comparison to the three-month period ended June 30, 2021. International sales aggregated 8% and 11% of total sales during the three-month periods ended June 30, 2022 and 2021, respectively. A material disruption in the supply of needed plastic syringes used in our gel product format limited our production and sales during the second quarter. We had a backlog of orders worth approximately $799,000 as of June 30, 2022 that all could have been shipped to customers erasing this drop in sales for the quarter, if not for this supply disruption that we are working to resolve during the third quarter. The three-month sales results are summarized in the following table:
| During the Three-Month Periods Ended June 30, | (Decrease) | |||||||||||||||
| (In thousands, except for percentages) | 2022 | 2021 | Amount | % | ||||||||||||
| Total product sales | $ | 3,861 | $ | 4,542 | ($ | 680 | ) | (15 | %) | |||||||
Sales increased by 14%, or $1.2 million, to $9.9 million during the six-month period ended June 30, 2022, in comparison to the six-month period ended June 30, 2021. Domestic sales increased by 19%, and international sales decreased by 24%, in comparison to the six-month period ended June 30, 2021. International sales aggregated 8% and 12% of total sales during the six-month periods ended June 30, 2022 and 2021, respectively. The six-month sales results are summarized in the following table:
| During the Six-Month Periods Ended June 30, | Increase | |||||||||||||||
| (In thousands, except for percentages) | 2022 | 2021 | Amount | % | ||||||||||||
| Total product sales | $ | 9,861 | $ | 8,649 | $ | 1,212 | 14 | % | ||||||||
Sales increased by 27%, or $4.3 million, to $20.5 million during the trailing twelve-month period ended June 30, 2022, in comparison to the trailing twelve-month period ended June 30, 2021. Domestic sales increased by 26%, and international sales increased by 30%, in comparison to the trailing twelve-month period ended June 30, 2021. International sales aggregated 12% and 11% of total sales during the trailing twelve-month periods ended June 30, 2022 and 2021, respectively. The trailing twelve-month sales results are summarized in the following table:
| During the Trailing Twelve-Month Periods Ended June 30, | Increase | |||||||||||||||
| (In thousands, except for percentages) | 2022 | 2021 | Amount | % | ||||||||||||
| Total product sales | $ | 20,455 | $ | 16,115 | $ | 4,340 | 27 | % | ||||||||
Sales of the First Defense® product line aggregated 99% and 98% of our total sales during the three-month periods ended June 30, 2022 and 2021, respectively, and 99% and 98% of our total sales during the six-month periods ended June 30, 2022 and 2021, respectively. We set successive records for high sales during the first quarter of 2022 and during the fourth, third and second quarters of 2021 in comparison to the same quarters of the prior years. Sales of the First Defense® product line increased from approximately $4,473,000 during the second quarter ended June 30, 2021 to $5,033,000 during the third quarter ended September 30, 2021 and further to $5,403,000 during the fourth quarter ended December 31, 2021 and further to $5,963,000 during the first quarter ended March 31, 2022. Our sales are seasonal with highest sales expected during the first quarter of each year. Most of our growth (when not limited by the backlog) is being realized through increased demand and a deliberate strategy to prioritize production capacity towards Tri-Shield First Defense® (the trivalent format of our product delivered via a gel tube), which provides broader protection to calves. The compound annual growth rate of our total product sales during the ten years ended December 31, 2021 was approximately 15%. The compound annual growth rate of our total product sales during the three years ended December 31, 2021 was approximately 18%.
Valuation of the backlog is a non-GAAP estimate that is based on purchase orders on hand at the time that could not be met because of a lack of available inventory. The backlog was worth approximately $2.4 million as of December 31, 2021 and approximately $799,000 as of June 30, 2022 and approximately $470,000 as of August 2, 2022. However, quantification of the backlog during the current periods has become far less comparable to prior periods. At times, customers have placed orders for more than a month’s worth of their demand, perhaps in reaction to our ongoing backlog situation, whereas in the past they ordered more closely in line with their more current demand.
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ImmuCell Corporation
While our backlog is a very positive indication about the strong demand for our First Defense® product line, we missed some business during 2021 as a result of the backlog. Not being able to timely meet the needs of our customers could result in the loss of some customers who seek alternative scours management products during this period of short supply and who may not resume purchasing our product when we have eliminated the backlog. While we worked to allocate product directly to certain large customers during this period of short supply, we likely lost some customers that could not access product. As we have more and more available inventory to sell during the second half of 2022, our job is to get back any lost customers and aggressively compete for new business. While backlog is a better problem to have than seeing product expiring on our shelves, it is nonetheless a significant challenge when we do not get our customers everything that they want. Our sales team is resuming more normal sales growth initiatives with more inventory becoming available as we move forward. We are working to regain customers that we may have lost while we were short on product. As we emerge from an extended period of time on backlog, we anticipate higher than normal sales fluctuations quarter to quarter. What is most important to us at this time is that we achieve sales growth over the longer periods of time, even if we experience some quarter-to-quarter fluctuations.
We recorded a 46% increase in sales during the first quarter of 2022 in comparison to the first quarter of 2021. This positive trend was not continued during the second quarter of 2022. The supply disruption pertaining to needed plastic syringes used in our gel product format, discussed above, resulted in the drop in sales during the second quarter. The failure to extend the positive growth trend may also be related to challenges we expect to face as we emerge from an extended period of order backlog. Distributor order patterns may also be inconsistent as we fill their open orders and as they adjust their inventory levels on hand. We do not solely benchmark our sales expectations off trailing twelve-month sales results. Instead, we look at the sales of competitive products to assess the size of the addressable market and plan for growth when projecting our future production capacity needs.
We completed the critical objectives of our investment to increase our First Defense® production capacity from approximately $16.5 million to approximately $23 million in terms of annual sales value during the fourth quarter of 2021. During the third quarter of 2021, we initiated an additional investment of approximately $960,000 to increase our annual production capacity for the First Defense® product line further from approximately $23 million to approximately $30 million or more per year by the end of third quarter of 2022 (see PROJECT F above). During the fourth quarter of 2021, we initiated an additional investment to further increase our annual First Defense® production capacity to approximately $35 million by the end of the fourth quarter of 2022 (see PROJECT G above). Equipment modifications and relocations of this nature require a shutdown of operations for weeks to months to install and validate the modified equipment and achieve USDA approval for its use in its new location. That must be managed carefully to minimize disruption. Considering the lead time required for facility modifications and equipment fabrication (which is approximately 18-24 months), during the second quarter of 2022, we initiated the preliminary steps related to an additional investment to increase this annual capacity further to approximately $42 million by the end of the second quarter of 2024 (see PROJECT H above). These investments have been and are being made to materially reduce the risk of another order backlog. We have been operating at very close to 100% of available capacity recently, which is not efficient or sustainable. Going forward, we will be in a position to operate at the capacity level we choose to cover sales with adequate buffer stock. The actual value of our production output varies based on biological and process yields, product format mix, selling price and other factors.
The significant global supply-chain disruptions that almost all industries are experiencing presently are a challenge to us and contribute to our order backlog. Prices for raw materials and critical supplies are increasing significantly, and it is more and more difficult to obtain timely delivery of the orders that we place. Therefore, we have little choice but to pay the higher prices and try to take on more months of supply than we would have held previously if we could get our orders fulfilled.
Effective January 1, 2022, we increased our selling price of the First Defense® product line by approximately 5% and CMT by approximately 7%. Effective January 1, 2021, we increased our selling price of the First Defense® product line in the domestic market by approximately 1.6% to 3%, depending on product format, and we increased our selling price of CMT by almost 4%.
Sales of products other than the First Defense® product line decreased by 45%, or $31,000, to $38,000 during the three-month period ended June 30, 2022 in comparison to the three-month period ended June 30, 2021. Sales of these other products aggregated approximately 1% and 2% of our total product sales during the three-month periods ended June 30, 2022 and 2021, respectively. Sales of products other than the First Defense® product line decreased by 51%, or $78,000, to $75,000 during the six-month period ended June 30, 2022 in comparison to the six-month period ended June 30, 2021. Sales of these other products aggregated approximately 1% and 2% of our total product sales during the six-month periods ended June 30, 2022 and 2021, respectively. We acquired a private label product (our second leading source of product sales during 2021) in connection with our January 2016 acquisition of certain gel formulation technology. This product was discontinued during the first quarter of 2022 because it was not a significant contributor to our total sales and it competed for valuable time and space in our production schedule. We sell our own CMT (our third leading source of product sales during 2021), which is used to detect somatic cell counts in milk.
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ImmuCell Corporation
Impact of Global COVID-19 Pandemic and Russia’s Unprovoked Military Invasion of Ukraine
We are facing significant production constraints, supply disruptions and inflationary increases which appear to have been caused, in large part directly or indirectly, by COVID and Russia’s unprovoked military invasion of Ukraine. The extent of the negative impact of the COVID-19 pandemic on the economics of our customers and on the demand for our products going forward is very difficult to assess. The Class III milk price has been extremely volatile during the pandemic. Initially, stay at home orders disrupted the food service supply system as schools closed and restaurants were shut down. In response, producers were forced to reduce the supply of milk to the market by drying off cows early, culling cows from the herd and dumping milk, among other tactics. Market conditions have improved somewhat, but this volatility remains a concern. Additionally, like most input costs, the cost of feed is rising, which puts a strain on the profitability of our customers.
Gross Margin
Changes in our gross margin (product sales less costs of goods sold) are summarized in the following table for the respective periods (in thousands, except for percentages):
| During the Three-Month Periods Ended June 30, | (Decrease) | |||||||||||||||
| 2022 | 2021 | Amount | % | |||||||||||||
| Gross margin | $ | 1,707 | $ | 2,074 | ($ | 367 | ) | (18 | %) | |||||||
| Percent of product sales | 44 | % | 46 | % | (1 | %) | (3 | %) | ||||||||
| During the Six-Month Periods Ended June 30, | Increase | |||||||||||||||
| 2022 | 2021 | Amount | % | |||||||||||||
| Gross margin | $ | 4,811 | $ | 3,677 | $ | 1,134 | 31 | % | ||||||||
| Percent of product sales | 49 | % | 43 | % | 6 | % | 15 | % | ||||||||
| During the Trailing Twelve-Month Periods Ended June 30, | Increase | |||||||||||||||
| 2022 | 2021 | Amount | % | |||||||||||||
| Gross margin | $ | 9,790 | $ | 7,020 | $ | 2,770 | 39 | % | ||||||||
| Percent of product sales | 48 | % | 44 | % | 4 | % | 10 | % | ||||||||
The gross margin as a percentage of product sales was 45%, 45%, 49%, 47% and 50% during the years ended December 31, 2021, 2020, 2019, 2018 and 2017, respectively. During the first quarter of 2021, the gross margin of 39% was lower than what we normally expect. This gross margin improved to 46% during the second quarter of 2021 and further to 47% during both the third and fourth quarters of 2021 and then further to 52% during the first quarter of 2022, as we began to spread these fixed costs over increasing production output. As we projected, this high percentage experienced during the first quarter of 2022 was not repeated during the second quarter of 2022. While our biological and process yields can be variable, we have seen a favorable improvement to our finished goods yield recently. We believe that gross margin results should be viewed over longer periods of time than just one quarter. For example, our gross margin was equal to 49.5% of sales during the six-month period ended March 31, 2022 and 49% of sales during the six-month period ended June 30, 2022. As we fully integrate and utilize our increased capacity, we expect to be able to achieve an annual gross margin in the range of 46% to 50%. The costs of our supplies, components, raw materials and services increased significantly during 2021 and that trend continues into 2022. The Tri-Shield® product format is more complex (i.e., three antibodies versus two antibodies for Dual-Force®) making it more costly to produce, and both the bivalent and trivalent gel product formats are more expensive to produce than the bolus format. These new formats are creating sales growth for us, and we are focused on increasing total gross margin dollars (after we fulfill the backlog) even if that is accomplished with a lower gross margin as a percentage of sales. We are investing significantly in equipment, infrastructure and operating expenses to increase our annual production capacity from approximately $16.5 million to approximately $42 million. Increased labor and other upfront costs were necessary to benefit from the scale-up of our production output going forward. A number of other factors contribute to the variability in our costs, resulting in some fluctuations in gross margin percentages from quarter to quarter and from year to year. Like most U.S. manufacturers, we have also been experiencing increases in the cost of labor and raw materials. We also invest to sustain compliance with current Good Manufacturing Practices (cGMP) in our production processes. Increasing production can be more expensive in the initial stages. To achieve our inventory production growth objectives, we are acquiring more raw material (colostrum) from many more cows at many new farms. As is the case with any vaccine program, animals respond less effectively to their first exposure to a new vaccine, and thereafter the effectiveness of their immune response improves in response to subsequent immunizations. During this expansion phase, colostrum quality can be more variable. Additionally, the biological yields from our raw material are always variable, which impacts our costs of goods sold in a similar way. Just as our customers’ cows respond differently to commercial dam-level vaccines, depending on time of year and immune competency, our source cows have similar biological variances in response to our proprietary vaccines. The value of our First Defense® product line is that we compensate for the variability in a cow’s immune response by standardizing each dose of finished product. This ensures that every calf is equally protected, which is something that dam-level commercial scours vaccines cannot offer. We continue to work on processing and yield improvements and other opportunities to reduce costs, while enhancing process knowledge and robustness. Over time, we have been able to reduce the impact of cost increases by implementing yield improvements. As we evaluate our product costs and selling price, one of our goals is to achieve a gross margin (before related depreciation and amortization expenses) as a percentage of total sales approaching 50%.
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ImmuCell Corporation
Product Development Expenses
Overview: The majority of our product development expenses pertain to the development of Re-Tain®. During the three-month period ended June 30, 2022, product development expenses increased to approximately $1.1 million in comparison to the approximately $1 million during three-month period ended June 30, 2021. Product development expenses aggregated 29% and 22% of product sales during the three-month periods ended June 30, 2022 and 2021, respectively. Product development expenses included approximately $349,000 and $386,000 of non-cash depreciation and stock-based compensation expenses during the three-month periods ended June 30, 2022 and 2021, respectively. During the six-month period ended June 30, 2022, product development expenses increased to approximately $2.2 million in comparison to approximately $2 million during the six-month period ended June 30, 2021. Product development expenses aggregated 22% and 23% of product sales during the six-month periods ended June 30, 2022 and 2021, respectively. Product development expenses included approximately $697,000 and $773,000 of non-cash depreciation and stock-based compensation expenses during the six-month periods ended June 30, 2022 and 2021, respectively. We do expect our product development expenses to decrease further after Re-Tain® is commercialized and some of the costs incurred to maintain and run our Drug Substance production facility become part of our costs of goods sold.
Development objective: As we work to revolutionize the way that mastitis is managed in the dairy industry, we aim to demonstrate that our polypeptide antimicrobial, Nisin A, can play a productive role in the treatment of subclinical mastitis in lactating cows by providing a novel alternative to traditional antibiotics. Earlier development work based on the safety profile of Nisin allowed us to establish a zero milk discard and a zero meat withhold claim for our product. This is a key competitive advantage because the milk discard requirement on all products on the market today is very costly to dairy operations. Common milk discard periods cover the duration of treatment and extend from 1.5 to 3 days after last treatment, depending on the antibiotic. On average, a cow produces approximately 60 to 80 pounds of milk per day. While milk prices vary significantly, at an average value of $18.00 per 100 pounds, a cow produces approximately $10.80 to $14.40 worth of milk per day. These estimated figures would result in milk discard costs ranging from approximately $37.80 (for 3.5 days of milk at 60 pounds per day) to $158.40 (for 11 days of milk at 80 pounds per day) per treated animal. We estimate that the approximate cost to the U.S. dairy industry of this discarded milk may be around $300 million per year. These high milk discard costs associated with traditional antibiotic treatments lead producers to only treat mastitis after clinical signs develop. The final and most critical development objective for Re-Tain® is to scale-up and achieve regulatory approval of our commercial manufacturing operations.
Development status: Approval by the Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA) of the New Animal Drug Application (NADA) for Re-Tain® is required before any sales of the product can be initiated. The NADA is comprised of five principal Technical Sections and a sixty-day administrative review at the end. Each Technical Section can be reviewed and approved separately. By statute, each Technical Section submission is generally subject to one or more six-month review cycles by the FDA. Upon review and assessment by the FDA that all requirements for a Technical Section have been met, the FDA may issue a Technical Section Complete Letter. The current status of our work on these submissions to the FDA is as follows:
| 1) | Environmental Impact: During the third quarter of 2008, we received the Environmental Impact Technical Section Complete Letter from the FDA. During the second quarter of 2021, we received further clarification through a new Environmental Impact Technical Section Complete Letter covering the current dosage regimen and labeling. |
| 2) | Target Animal Safety: During the second quarter of 2012, we received the Target Animal Safety Technical Section Complete Letter from the FDA. |
| 3) | Effectiveness: During the third quarter of 2012, we received the Effectiveness Technical Section Complete Letter from the FDA. The anticipated product label (which remains subject to FDA approval) carries claims for the treatment of subclinical mastitis associated with Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, and coagulase-negative staphylococci in lactating dairy cattle. |
| 4) | Human Food Safety: During the third quarter of 2018, we received the Human Food Safety Technical Section Complete Letter from the FDA confirming, among other things, a zero milk discard period and a zero meat withhold period during and after treatment with our product. Achieving this critical differentiating feature for our product encouraged us to continue the significant product development investment necessary to bring Re-Tain® to market. It would have been hard to justify an ongoing investment of this nature in a product without this significant competitive advantage. During the second quarter of 2021, we updated this Technical Section Complete Letter with FDA approval of the official analytical method to measure Nisin in milk. |
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ImmuCell Corporation
| 5) | Chemistry, Manufacturing and Controls (CMC): The CMC Technical Section is very complex and comprehensive. Having previously achieved the four different Technical Section Complete Letters from the FDA discussed above, approval of the CMC Technical Section is the fifth and final significant step required before Re-Tain® product sales can be initiated in the United States. Implementing Nisin Drug Substance (the active pharmaceutical ingredient, or DS) production, which is a required component of the CMC Technical Section, has been the most expensive and lengthy part of this project. We previously entered into an agreement with a multi-national pharmaceutical ingredient manufacturer for our commercial-scale supplies of DS. However, we determined during 2014 that the agreement did not offer us the most advantageous supply arrangement in terms of either cost or long-term dependability. Then we presented this product development opportunity to a variety of large and small animal health companies. While such a corporate partnership could have provided access to a much larger sales and marketing team and allowed us to avoid the large investment in a commercial-scale production facility, we concluded that a partner would have taken an unduly large share of the gross margin from all future product sales of Re-Tain®. However, the regulatory and marketing feedback that we received from prospective partners, following their due diligence, was positive. During the third quarter of 2014, we completed an investment in facility modifications and processing equipment necessary to produce our DS at small-scale at our 56 Evergreen Drive facility. This small-scale facility was used to: i) expand our process knowledge and controls, ii) establish operating ranges for critical process parameters, iii) conduct product stability studies, iv) optimize process yields and v) verify the cost of production. We believe these efforts have reduced the risks associated with our investment in the commercial-scale DS production facility. Having raised equity during 2016 and 2017, we were able to move away from these earlier partnering strategies and assume control over the commercial-scale manufacturing process in our own facility. During the fourth quarter of 2015, we acquired land near our existing Portland facility for the construction of a new commercial-scale DS production facility. We commenced construction of this facility during the third quarter of 2016 and completed construction during the fourth quarter of 2017. Equipment installation and qualification was initiated during the third quarter of 2017 and completed during the third quarter of 2018. Total construction and equipment costs aggregated approximately $20.8 million. With construction of the facility complete, we continue to work with outside parties to investigate improvements to our DS production yields as well as potential efficacy enhancements. |
Under the FDA’s phased submission process, we made a first-phased submission covering just the DS during the first quarter of 2019. The first-phased DS submission included data from the DS Registration Batches produced at commercial scale in our new DS manufacturing facility. This first-phased submission was followed by a second-phased submission covering both the DS and the formulated Drug Product (DP), during the first quarter of 2021. This two-phased submission process allowed us to respond to identified queries and/or deficiencies from the first-phased DS submission at the time of the second-phased combined DS and DP submission. The second-phased DS and DP submission responded to comments raised by the FDA regarding the first-phased DS submission and included detailed information about the manufacturing process and controls for DP. One of the key components of the second-phased DS and DP submission was also demonstrating stability of the product through expiry. During the third quarter of 2021, the FDA issued a Technical Section Incomplete Letter with regard to this second-phased DS and DP submission. This response was not unexpected as it is common for the FDA to issue queries and comments, especially related to an aseptic DP submission with associated sterilization validation information. We made a second submission of the DS and DP Technical Section during the first quarter of 2022. During the third quarter of 2022, we received a Technical Section Incomplete Letter from the FDA with regards to our second DS and DP submission of the CMC Technical Section. In response, we intend to make a third submission of the CMC Technical Section during the third quarter of 2022. The principal issue remaining is a successful pre-approval re-inspection of our manufacturing facility. We are completing preparations for such and intend to notify the FDA of our readiness for the pre-approval re-inspection during the third quarter. Continued focus on these preparations is critical to a successful pre-approval re-inspection outcome. No substantive issues were raised in the other six FDA comments (in addition to the comment requiring a successful pre-approval re-inspection), and the comments are not related to the safety or efficacy of the product. The comments from the FDA require that we provide additional information about raw material specifications, DS labeling and stability testing. These comments principally relate to DP, not DS. This clarifies the required path to product approval. Our CMC Technical Section submission will be subject to a statutory six-month review period by the FDA. We believe we can successfully complete the pre-approval re-inspection inside of this time frame.
While being prudent with how much cash we invest into inventory that would have short expiry dating if market launch is delayed, we are building more inventory during 2022 to bridge the transition between DP supply from our contract manufacturer to our own in-house services. We need to manage the amount of DP inventory we build pre-approval during the end of this year with associated expirations dating during the end of 2024. This inventory must support the market needs and have sufficient dating to bridge the transition from our contract manufacturing agreement to when our in-house DP production is approved by the FDA. We must consider short expiry dating in the event that our NADA approval is delayed as well as manage the number of new customers we obtain at launch in order to minimize potential supply disruptions.
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ImmuCell Corporation
Our DS manufacturing facility and that of our DP contract manufacturer (and our future DP manufacturing facility) are subject to ongoing FDA inspections. During the third quarter of 2019, the FDA conducted a pre-approval inspection of our DS facility. This resulted in the issuance of certain deficiencies as identified on the FDA’s Form 483. We submitted responses and data summaries in a phased manner over the fourth quarter of 2019 and first quarter of 2020. During the first quarter of 2022, the FDA conducted another pre-approval inspection of our DS facility. This also resulted in the issuance of certain deficiencies as identified on the FDA’s Form 483. We have since responded to all of the queries and are preparing for a re-inspection. This inspection process has been managed without significant cost.
We have always believed that the fastest route to FDA approval and market launch is with the services of Norbrook Laboratories Limited of Newry, Northern Ireland (an FDA-approved DP manufacturer) (Norbrook), reducing our risk by benefiting from their demonstrated expertise in aseptic filling. From 2010 to the present, we have worked with Norbrook under several amended contract manufacturing agreements covering the DP formulation, aseptic filling and final packaging services. Under our current agreement, Norbrook has agreed to provide the formulation, aseptic filling and final packaging services as required in order for us to submit the CMC Technical Section to the FDA and to provide a supply of product during 2022 that we believe will enable us to commence sales of Re-Tain® without delay upon receipt of the anticipated FDA approval and provide us with a supply bridge until our own formulation and aseptic filling capacity is available, which is anticipated by the second quarter of 2024 (see PROJECT D above). DP produced under this agreement during the end of 2022 is expected to have expiry dating during the end of 2024.
Our potential alternative third-party options for the formulation and aseptic filling services that are presently being performed by Norbrook are narrowed considerably because our product cannot be formulated or filled in a facility that also processes traditional antibiotics (i.e., beta lactams). Consequently, we have decided to perform these services internally (see PROJECT D above). We are investing approximately $4 million in the equipping and commencement of operations of our own DP formulation and aseptic filling facility. We began initial equipment installation during the first quarter of 2022. Subject to the timing of our installation and validation work, we anticipate FDA approval of this facility (which is a requirement for commercial manufacturing) during the fourth quarter of 2023 if the FDA requires only one six-month review cycle or by the second quarter of 2024 if the FDA requires two six-month review cycles. This new facility will be subject to FDA inspection and approval and will have enough formulation and aseptic filling capacity to exceed the expected production capacity of our DS facility, which is at least $10 million in annual sales. This production capacity estimate is based on our assumptions as to product pricing and does not yet reflect inventory build strategies in advance of product approval or ongoing yield improvement initiatives. Establishing our own DP formulation and aseptic filling capability provides us with the longer-term advantage of controlling the manufacturing process for Re-Tain® in one facility, thereby potentially reducing our manufacturing costs and eliminating international cold chain shipping logistics and costs. The DP formulation and aseptic filling operation will be located in existing facility space that we had intended to utilize to double our DS production capacity if warranted by sales volumes following market launch. As a result, we would need to explore alternative strategies (in parallel with ongoing DS yield improvement initiatives) to expand our DS production capacity. This integrated manufacturing capability for Re-Tain® will substantially reduce our dependence on third parties. Upon completion of our formulation and aseptic filling facility, the only significant third-party input for Re-Tain® will be the DP syringes. It is anticipated that Hubert De Backer of Belgium (HDB) will supply these syringes in accordance with purchase orders that we submit. HDB is a syringe supplier for many of the largest participants in the human and veterinary medical industries, and with whom Norbrook presently works. Based on HDB’s performance history and reputation in the industry, we are confident that HDB will be a dependable supplier of syringes in the quantity and of the quality needed for Re-Tain®.
Other product development initiatives: Our second most important product development initiative has been focused on other improvements, extensions or additions to our First Defense® product line. We are currently working to establish USDA claims for our bivalent bulk powder formulation of First Defense Technology®. Subject to the availability of resources, we intend to begin new development projects that are aligned with our core competencies and market focus. We also remain interested in acquiring, on suitable terms, other new products and technologies that fit with our sales focus on the dairy and beef industries, subject to the availability of the needed funding.
Sales and Marketing
During the three-month period ended June 30, 2022, sales and marketing expenses increased by approximately 51%, or $222,000, to $659,000 in comparison to $437,000 during the three-month period ended June 30, 2021, amounting to 17% and 10% of product sales during the three-month periods ended June 30, 2022 and 2021, respectively. Sales and marketing expenses included approximately $44,000 and $13,000 of non-cash depreciation and stock-based compensation expenses during the three-month periods ended June 30, 2022 and 2021, respectively. During the six-month period ended June 30, 2022, sales and marketing expenses increased by approximately 54%, or $513,000, to approximately $1.5 million in comparison to $958,000 during the six-month period ended June 30, 2021, amounting to 15% and 11% of product sales during the six-month periods ended June 30, 2022 and 2021, respectively. Sales and marketing expenses included approximately $79,000 and $31,000 of non-cash depreciation and stock-based compensation expenses during the six-month periods ended June 30, 2022 and 2021, respectively. We do expect these expenses to increase to approximately 20% of total product sales during 2022 as we begin to invest in the anticipated market launch of Re-Tain® before any new sales are realized. Our budgetary guideline for 2022 and after is to keep these expenses under 20% of total sales. We continue to leverage the efforts of our small sales force by using animal health distributors.
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ImmuCell Corporation
The First Defense® product line serves dairy and beef producers by protecting their calf crop from scours, the leading cause of pre-weaning mortality and morbidity. When calves are healthy during this crucial development period, they mature into more productive milking cows and more efficient beef generators.
Our primary competition in this category is vaccines that are also regulated for effectiveness and safety by the USDA. However, vaccine results are inherently variable. COVID breakthrough infections in humans have reminded us that a vaccine does not guarantee immunity. That is true for our competitors as well. In the most controlled research settings, only 80% of animals respond to a vaccine. This leaves 20% of the calf crop unprotected when the scour prevention program relies on scour vaccines. Those unprotected calves can be disease carriers. Not only are they more susceptible to death or likely to require life-saving treatment (sometimes with antibiotics), but they also shed pathogens into the environment creating a greater disease pressure for their herd mates. The First Defense® product line removes the inconsistency inherent with vaccine protection. We sell the only USDA-licensed products in the scour prevention category that are therapeutic polyclonal antibodies. This technology eliminates a producer’s reliance on a variable vaccine response to generate antibodies and, instead, can protect every calf equally with a measured dose of antibody-driven immunity against both bacterial and viral scour pathogens.
In this space, we treat more calves than our competitors that are primarily vaccines administered directly to the calf at birth, and we are second in sales dollars to the market leader within the dam-level competitor category, which constitutes vaccines given to the cow pre-calving. Despite these successes, there remains significant opportunity to displace more competition within North America. There is also opportunity to grow our sales by expanding into international markets. We are being strategic in how we invest in international market development in order not to divert our limited resources away from achieving domestic growth, which is often more efficient to obtain.
Our expanded sales and marketing team has proven to be a worthy investment, validating that our message resonates well with customers. Now that our increased production capacity is in place and our supply has caught up with demand, we anticipate being able to escalate our growth curve after we recover from the brand damage that can come with an extended duration of short supply. We see ourselves as the “non-pharma” pharma company. Rather than offering variations of “me-too” technology like vaccines and antibiotics, we have taken the path less traveled by developing first-of-their kind products fueled by novel active ingredients such as polyclonal antibodies (for First Defense®) and bacteriocins (for Re-Tain®). We anticipate that these category developing innovations will drive greater value for the livestock industry and, in turn, for our stockholders.
We believe that Re-Tain® could revolutionize the way that mastitis is managed by making earlier treatment of subclinical infections (while these cows are still producing saleable milk) economically feasible by not requiring a milk discard or a meat withhold during, or for a period of time after, treatment. No other FDA-approved mastitis treatment product on the market can offer this value proposition. We believe we can demonstrate a return on investment to the dairy producer and the milk processor that will justify a premium over other mastitis treatments on the market today, which are all sold subject to milk discard and meat withhold requirements. By creating this value for our customers, we believe we can, in turn, create value for our stockholders.
Re-Tain® could increase the lifetime profitability of a cow and reduce disease transfer to herd mates. It is generally current practice to treat mastitis only when the disease has progressed to the clinical stage where the milk from an infected cow cannot be sold, leaving most subclinically infected cows untreated. Without a milk discard cost, we expect producers to be more motivated to identify and treat cows at the subclinical stage. This creates a substantial animal welfare benefit. By treating mastitis early at the subclinical level, producers could preserve optimal milk yields. We also know that animals infected with subclinical mastitis have higher abortion rates and often progress to the clinical disease state requiring antibiotic treatment and milk discard. We believe that societal animal welfare objectives will put more and more pressure on the industry to treat cows with subclinical infections.
It is common practice to move sick cows from their regular herd group to a sick cow group for treatment and the related milk discard. This movement causes stress on the cow and a reduction in milk production. While practices may vary farm-to-farm, there would be no requirement to move cows treated with our product, allowing this costly drop in production to be avoided.
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ImmuCell Corporation
The over-use of antibiotics that are medically important to human healthcare is a growing public health concern of our society and an active issue with the FDA, largely because of the growing evidence that this over-use contributes to antibiotic resistance and the rise of “super-bugs”. Sustainability objectives require that less antibiotics be used in food producing animals, yet a new FDA-approved drug to treat mastitis has not been developed in years. Our product improves sustainability by utilizing a polypeptide antimicrobial as an alternative to traditional antibiotics that are used in human medicine. In the big picture, we are introducing an entirely new class of antimicrobial as an animal drug, a bacteriocin, that does not promote resistance against antibiotics used in human medicine making it more socially responsible. As the great NHL hockey player, Wayne Gretzky, is known to have said, “I skate to where the puck is going to be, not where it has been.” This is motivational to us. The industry could keep treating this very significant disease with traditional antibiotics, but it takes innovation to bring a polypeptide antimicrobial like Nisin to market. Re-Tain® would, when introduced, offer a needed alternative to these traditional antibiotics, while at the same time improving milk quality and the quantity of milk produced by treated cows. We believe our product fits very well with where the industry is going to be in the coming years.
As with all new products, the market determines the value. Our objective is to gain market acceptance of this new product concept as we develop a new product category. Despite those exciting benefits, it will take time to change this longstanding treatment paradigm and develop this new market. It will take time for the market to understand, evaluate, implement and adapt to the use and benefits of Re-Tain®. We believe that the primary market for Re-Tain® (at least initially) may be limited to the approximately half of farms that have access to somatic cell count data at the cow or quarter level, since that is the most common and efficient way to identify subclinical infections and to assess the effectiveness of treatment.
As we prepare for market launch after we receive the anticipated and required FDA approval of this product, we continue to carefully consider our best go-to-market strategy in consultation with industry-leading consultants, veterinarians, dairy producers and others. Informed by consultations with these industry experts and key opinion leaders, we have opted to carefully control the launch of this novel product over the first eighteen months or so after FDA approval, as we seek to revolutionize the way that mastitis is treated in the dairy industry over the long term. Under this controlled launch, our sales and technical support team will work directly with early adopters to ensure that the best treatment candidates are selected and that the product is properly administered in accordance with its label, creating exceptional customer experiences and strong customer testimonials. The goal of our direct sales team is to help early adopters develop easy to use protocols, optimize treatment results and realize a positive return on their investment. We intend to limit initial distribution of Re-Tain® to a level that enables our sales team to select the optimal dairy farms at which to introduce Re-Tain® and to limit the initial numbers of participating farms so that the desired levels of support and guidance relating to effective usage of Re-Tain® can be provided. We believe that the operational adjustments and accommodations that dairy farmers will need to make to effectively use Re-Tain® and avoid the potential problems described below under PART II: OTHER INFORMATION ITEM 1A – RISK FACTORS, “Product Risks”, to this Quarterly Report will not be so burdensome as to deter its adoption and usage. Our overarching objective is to minimize the risk of early-stage unsatisfactory outcomes that could harm the longer-term prospects and market acceptance of Re-Tain®. This strategic choice means that we have elected not to pursue an alternative strategy that might have maximized short-term, initial sales quickly through a mass market approach where we provide product to distribution and let them sell it to as many farms as possible. While we are dedicated to increasing our sales revenue, we must consider the damage a pre-mature mass market strategy could cause to the long-term value of the product. We have seen products sold by much larger companies that were substantially damaged by such failed market launch strategies. The goal of these prudent steps is to create a smooth and successful launch with the momentum to optimize product sales over the longer period, while safeguarding the longer-term performance of our investment in Re-Tain®. Secondarily, this strategy also reduces the amount of inventory that we would need to build at risk before regulatory approvals of the product and our production facilities are achieved, and it reduces the amount of cash we would need to spend to purchase inventory from our contract manufacturer before our in-house aseptic filling services are approved by the FDA.
It is difficult to accurately estimate the potential size of the market for the treatment of subclinical mastitis because presently this disease is largely left untreated. We believe that approximately 20-40% of the U.S. dairy herd is infected with subclinical mastitis at any given time. This compares to approximately 2% of the U.S. herd that is thought to be infected with clinical mastitis, where approximately $60 million per year is spent on drug treatments. Finding candidate cows will require farms to obtain monthly individual cow somatic cell count (SCC) data through participation in organizations such as the National Dairy Herd Improvement Association (DHIA) or by installing monitors to indicate high SCC cows or a potential health event. DHIA testing can provide this data monthly, and emerging technology can provide this data real-time. Testing results at an elevated level could indicate a good treatment candidate. Likewise, testing results showing a reduced level after treatment could indicate a treatment success. To reach the portion of the market that does not have access to this data presently, we would need to show new customers that the benefit of using our product is worth the roughly $2.00 per cow per month test cost. Similar market opportunities are likely to exist outside the United States. We believe the use of Re-Tain® could be expanded, with additional data and regulatory approval, to support treatment late in lactation and possibly for clinical stage mastitis. We also believe there may be a market for Re-Tain® in small ruminants (such as goats and sheep) where the majority of mastitis cases are caused by strep-like organisms aligned with our effectiveness data.
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We expect the Drug Substance production facility that we constructed for approximately $20.8 million to have initial annual production capacity sufficient to meet at least $10 million in sales of Re-Tain® at current production yields. This production capacity estimate does not yet reflect any inventory build strategies or ongoing yield improvement initiatives. Expansion of the estimated annual capacity of the Drug Substance facility beyond approximately $10 million (without factoring in potential yield improvements) would require relocation of the Drug Product formulation and aseptic filling module to another facility, or the acquisition and equipping of other Drug Substance production facilities or adopting alternative manufacturing strategies.
As disclosed in previously filed reports, we have made preliminary assessments and estimates relating to the market opportunity for Re-Tain®, both during and after its initial launch, and have described the principal challenges facing the launch of a new product by a company such as ours with limited sales, marketing and financial resources into a competitive market populated with several global pharmaceutical enterprises. We expect annual sales to be well below the $36.1 million level that we previously estimated as the potential of the market opportunity for our product five years after product launch. This is because we are taking a more controlled launch approach, respecting the challenges of introducing a paradigm changing technology. We are going to be very transparent with the launch of Re-Tain®. To that end, we have expanded Note 17, “Segment Information”, to the accompanying unaudited financial statements to now display a break-out of our financial results among the following two components of our business: i) Scours and ii) Mastitis. This will allow investors to see our progress as we develop both product categories. We generally do not provide financial projections, as we know such projections can prove to be materially inaccurate. However, in this case, we are providing a high-level projection for Re-Tain® that under this controlled launch plan strategy, we think we can achieve sales of approximately $1 million during the first year on the market and then about double that during the second year on the market. If we are successful with this launch strategy, we would aim pivot to a mass market sales approach with our distributors and grow this curve after the first 18 to 24 months on the market. Actual sales results will vary from these projections up or down. We believe this strategy lends itself to a more gradual adoption curve but higher and more sustainable sales over the long-term.
Administrative Expenses
During the three-month period ended June 30, 2022, administrative expenses increased by 25%, or approximately $107,000, to $528,000 in comparison to $422,000 during the three-month period ended June 30, 2021. Administrative expenses included approximately $33,000 and $25,000 of non-cash depreciation and stock-based compensation expenses during the three-month periods ended June 30, 2022 and 2021, respectively. During the six-month period ended June 30, 2022, administrative expenses increased by 17%, or approximately $144,000, to $991,000 in comparison to $847,000 during the six-month period ended June 30, 2021. Administrative expenses included approximately $66,000 and $55,000 of non-cash depreciation and stock-based compensation expenses during the six-month periods ended June 30, 2022 and 2021, respectively. We strive to be efficient with these expenses while funding costs associated with complying with the Sarbanes-Oxley Act of 2002 and all the legal, audit and other costs associated with being a publicly-held company. Prior to 2014, we had limited our investment in investor relations spending. Beginning in the second quarter of 2014, we initiated an investment in a more active investor relations program. Given travel restrictions related to the COVID-19 pandemic, this initiative has pivoted to a virtual meeting format, which is less expensive. Having experienced this efficiency, it is our intent to continue with the same strategy, for the most part, even as travel restrictions continue to be reduced. At the same time, we continue to provide full disclosure of the status of our business and financial condition in three quarterly reports and one annual report each year, as well as in Current Reports on Form 8-K when legally required or deemed appropriate by management. We believe these efforts have helped us access the capital markets to fund our growth objectives. Considering inflation and all the necessary support services that fit into this category, we believe that approximately $2 million per year is an efficient budget goal to fund the administrative expenses of a publicly-held company.
Net Operating (Loss) Income
During the three-month period ended June 30, 2022, our net operating (loss) of ($619,000) was in contrast to a net operating income of $216,000 during the three-month period ended June 30, 2021. The decrease in product sales during the second quarter of 2022, which resulted in a $367,000 decrease in gross margin during the second quarter of 2022, compared to the second quarter of 2021, was the largest contributor to this swing from to income to loss. During the six-month period ended June 30, 2022, our net operating income of $174,000 was in contrast to a net operating (loss) of ($159,000) during the six-month period ended June 30, 2021. The substantial increase in product sales at a higher gross margin as a percentage of sales during the first six months of 2022, compared to the first six months of 2021, was the largest contributor to this swing from loss to income.
Other Expenses, net
During the three-month period ended June 30, 2022 other expenses, net, aggregated $64,000 in comparison to other expenses, net, of $74,000 during the three-month period ended June 30, 2021. Interest expense increased to $90,000 during the three-month period ended June 30, 2022 from $79,000 during the three-month period ended June 30, 2021. Non-cash amortization of debt issuance costs (which is included as a component of interest expense) was $2,000 during both of the three-month periods ended June 30, 2022 and 2021. Interest income was $26,000 and $5,000 during the three-month periods ended June 30, 2022 and 2021, respectively. More interest income was earned during 2022 largely because of the higher interest rate environment.
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During the six-month period ended June 30, 2022 other expenses, net, aggregated $120,000 in comparison to other expenses, net, of $141,000 during the six-month period ended June 30, 2021. Interest expense increased to $165,000 during the six-month period ended June 30, 2022 from $159,000 during the six-month period ended June 30, 2021. Non-cash amortization of debt issuance costs (which is included as a component of interest expense) was $4,000 during both of the six-month periods ended June 30, 2022 and 2021. We anticipate that our interest expense will be approximately $338,000, $352,000 and $323,000 during the years ending December 31, 2022, 2023, and 2024, respectively (includes interest expense on the MTI loans). Interest income was $33,000 and $8,000 during the six-month periods ended June 30, 2022 and 2021, respectively. More interest income was earned during 2022 largely because we had more cash on hand during the first quarter of 2022 compared to the first quarter of 2021 during a higher interest rate environment. The results for the first half of the years included $11,000 and $10,000 from the sale of fixed assets during the six-month periods ended June 30, 2022 and 2021, respectively.
(Loss) Income Before Income Taxes
During the three-month period ended June 30, 2022, our (loss) before income taxes was ($683,000) in contrast to income before income taxes of $141,000 during the three-month period ended June 30, 2021. During the six-month period ended June 30, 2022, our income before income taxes was $54,000 in contrast to a (loss) before income taxes of ($300,000) during the six-month period ended June 30, 2021.
Income Taxes and Net (Loss) Income
During the three-month periods ended June 30, 2022 and 2021, we recorded income tax expense of $1,000 and $0, respectively, which is comprised of state tax liabilities. During the six-month periods ended June 30, 2022 and 2021, we recorded income tax expense of $2,000 and $0, respectively, which is comprised of state tax liabilities. Our net (loss) of ($684,000), or ($0.09) per basic share, during the three-month period ended June 30, 2022 was in contrast to a net income of $141,000, or $0.02 per diluted share, during the three-month period ended June 30, 2021. Our net income of $52,000, or $0.01 per diluted share, during the six-month period ended June 30, 2022 was in contrast to a net (loss) of ($300,000), or ($0.04) per basic share, during the six-month period ended June 30, 2021.
We have substantial net operating loss carryforwards that largely offset our income tax expense. For tax return purposes only, our depreciation expense for the Nisin Drug Substance production facility and equipment was approximately $492,000, $464,000, $639,000, $9.2 million and $1.5 million for the years ended December 31, 2021, 2020, 2019, 2018 and 2017, respectively. The significant increase during 2018 was largely related to accelerated depreciation allowed for tax purposes. As of December 31, 2021, our federal net operating loss carryforward was approximately $14.7 million, which will be available to offset future taxable income, subject to possible annual limitations based on ownership changes. On December 22, 2017, the Tax Cuts and Jobs Act was signed into law. This legislation makes significant changes in the U.S. tax laws, including a reduction in the corporate tax rates, changes to net operating loss carryforwards and carrybacks, and a repeal of the corporate alternative minimum tax. The legislation reduced the U.S. corporate tax rate from 34% to 21%. Our income tax rate differs from this standard tax rate primarily because we are currently providing for a full valuation allowance against our deferred tax assets. While we are recording this full valuation allowance, we are not recognizing the benefit of our tax losses.
In addition to the results discussed above from our Statements of Operations, we believe it is important to consider our Statements of Cash Flows in the accompanying unaudited financial statements to assess the cash generating ability of our operations.
Critical Accounting Policies
The financial statements are presented on the basis of accounting principles that are generally accepted in the United States. All professional accounting standards that were effective and applicable to us as of June 30, 2022 have been taken into consideration in preparing the financial statements. The preparation of financial statements requires that we make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to revenue recognition, income taxes, contingencies and the useful lives and carrying values of intangible and long-lived assets. We base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We have chosen to highlight certain policies that we consider critical to the operations of our business and understanding our financial statements.
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ImmuCell Corporation
We sell products that provide Immediate Immunity™ to newborn dairy and beef cattle. We recognize revenue in accordance with the five step model in ASC 606. These include the following: i) identification of the contract with the customer, ii) identification of the performance obligations in the contract, iii) determination of the transaction price, iv) allocation of the transaction price to the separate performance obligations in the contract and v) recognition of revenue associated with performance obligations as they are satisfied. We recognize revenue at the time of shipment (including to distributors) for substantially all products, as title and risk of loss pass to the customer on delivery to the common carrier after concluding that collectability is reasonably assured. We do not bill for or collect sales tax because our sales are generally made to distributors and thus our sales to them are not subject to sales tax. We generally have experienced an immaterial amount of product returns.
Inventory includes raw materials, work-in-process and finished goods and is recorded at the lower of cost, on the first-in, first-out method, or net realizable value (determined as the estimated selling price in the normal course of business, less reasonably predictable costs of completion, disposal and transportation). Work-in-process and finished goods inventories include materials, labor and manufacturing overhead. Inventory is a critical accounting policy because of the estimates and assumptions used by management to determine its cost accounting and because of the variability of the cost per dose due to fluctuations in the biological yield.
ITEM 3 — QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Inflation, interest rates and currency exchange rates are having a more adverse effect on our revenues and expenses than we previously experienced. Future increases in inflation or interest rates could affect our customers and the demand for our products. We hope to increase the level of our future sales of products outside the United States. The cost of our products to international customers could be affected by currency fluctuations. The decline of the U.S. dollar against other currencies could make our products less expensive to international customers. Conversely, a stronger U.S. dollar could make our products more costly for international customers. The current devaluation of the dollar makes Euro-based purchases more expensive for us. We had outstanding bank debt totaling approximately $9.9 million as of June 30, 2022 that bears interest at the blended fixed rate of 3.52% per annum. Also, as of June 30, 2022, we had two subordinated loans from the State of Maine outstanding aggregating $900,000. The first loan bears no interest until the fourth quarter of 2022, at which time it bears interest at a fixed rate of 5% per annum, unless it is repaid. The second loan bears no interest until the third quarter of 2023, at which time it bears interest at a fixed rate of 5% per annum, unless it is repaid. See Note 10 to the accompanying unaudited financial statements for more details about our debt.
ITEM 4 — CONTROLS AND PROCEDURES
Disclosure Controls and Procedures: Our management, with the participation of the individual who serves as our principal executive and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2022. Based on this evaluation, that officer concluded that our disclosure controls and procedures were effective as of that date. Disclosure controls and procedures are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our principal executive and principal financial officer, as appropriate to allow timely decisions regarding required disclosures.
Management’s Quarterly Report on Internal Control Over Financial Reporting: The management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting. The Company’s internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. We conducted an evaluation of the effectiveness of the internal controls over financial reporting based on the framework in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. This evaluation included a review of the documentation of controls, evaluation of the design effectiveness of controls, testing the operating effectiveness of the controls and a conclusion on this evaluation. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Management assesses the effectiveness of the Company’s internal control over financial reporting at the end of each quarter. Based on management’s assessment, we believe that our internal control over financial reporting was effective as of June 30, 2022. This Quarterly Report does not include an attestation report of the Company’s independent registered public accounting firm regarding internal control over financial reporting. Management’s internal control report was not subject to annual or quarterly attestation by the Company’s independent registered public accounting firm pursuant to rules of the Securities and Exchange Commission that permit the Company to provide only management’s report.
Changes in Internal Controls over Financial Reporting: The individual who serves as our principal executive and principal financial officer periodically evaluates any change in internal control over financial reporting which has occurred during the prior fiscal quarter. We have concluded that there was no change in our internal control over financial reporting that occurred during the quarter ended June 30, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II: OTHER INFORMATION
ITEM 1 — LEGAL PROCEEDINGS
In the ordinary course of business, we may become subject to lawsuits, investigations and claims. Although we cannot predict with certainty the ultimate resolution of any such lawsuits, investigations and claims against us, we do not believe that any pending or threatened legal proceedings to which we are or could become a party will have a material adverse effect on our business, results of operations, or financial condition.
ITEM 1A — RISK FACTORS
Financial Risks
Gross margin on product sales: One of our goals is to achieve a gross margin (before related depreciation expenses) as a percentage of total sales of approximately 50% after the initial launch of new products. Depreciation expense will be a larger component of costs of goods sold for Re-Tain® than it is for the First Defense® product line. Gross margins generally improve over time, but this anticipated improvement may not be realized for Re-Tain®. Many factors discussed in this report (including the COVID-related cost increases, supply-chain disruptions and the rising price of oil and other commodities and supplies) impact our costs of goods sold. There is a risk that we are not able to achieve our gross margin goals, which would adversely affect our operating results and could impact our future operating plans. There is a risk that our plans to maintain or improve our gross margin may not be realized due to cost increases, inability to raise our selling prices, or both.
Exposure to interest rates and debt service obligations: Rising interest rates could negatively affect the operating costs of dairy and beef producers and thus put further financial pressure on an already stressed business sector, which could indirectly affect our business. We removed the direct aspect of this particular exposure to our business by refinancing our bank debt to fixed rate notes at 3.50% per annum during the first quarter of 2020. The $2 million in additional mortgage debt we secured during the first quarter of 2022 bears interest at the fixed rate of 3.58%. However, the additional debt we incurred to fund our growth objectives has significantly increased our total debt service costs. Reflecting the mortgage debt financing we completed during the first quarter of 2022, we are obligated to make principal and interest payments aggregating approximately $1.2 million during the year ending December 31, 2022 and approximately $1.4 million during the year ending December 31, 2023. See Note 10 to the accompanying unaudited financial statements for more information. A decline in sales or gross margin, coupled with this debt service burden, could impair our ability to fund our capital and operating needs and objectives.
Debt covenants: Our bank debt is subject to certain financial covenants. We are required to meet a minimum debt service coverage (DSC) ratio of 1.35, which is measured annually. Our actual DSC ratios were 2.68 and 2.03 for the years ended December 31, 2021 and 2020, respectively. However, based on current projections of our future financial performance, which includes a high level of ongoing product development expenses to support Re-Tain®, we may not satisfy this annual requirement for the year ending December 31, 2022, and there can be no assurance that we can exceed that required level in subsequent years. By negotiation with the bank in connection with a mortgage debt financing during the first quarter of 2022, the required minimum DSC ratio was reduced to 1.0 for the year ending December 31, 2022.
Inflation: Inflation is having a material and adverse impact on almost all supplies we purchase and labor we hire. Continuing or increasing inflationary trends could materially reduce our gross margin on product sales. According to the Consumer Price Index for All Urban Consumers (CPI-U) during the twelve-month period ended June 30, 2022, the all items index increased 9.1% before seasonal adjustment.
Projection of net (loss) income: Generally speaking, our financial performance can differ significantly from management projections, due to numerous factors that are difficult to predict or that are beyond our control. Weaker than expected sales of the First Defense® product line could lead to less profits or deeper operating losses. The timing of FDA approval of Re-Tain® will have a material impact on our net (loss) income until sufficient commercial sales are initiated.
Risks associated with our funding strategy for Re-Tain®: The inability to maintain adequate cash and liquidity to support the commercialization of Re-Tain® is a risk to our business. Achieving FDA approval of our pharmaceutical-grade Nisin produced at commercial-scale is the most critical action remaining in front of us on our path to U.S. regulatory approval of Re-Tain®. Having completed the construction and equipping of the Drug Substance production facility described elsewhere in this report at a cost of approximately $20.8 million, we will continue to incur product development expenses to operate and maintain this facility until commercialization. Absent sufficient sales of Re-Tain® at a profitable gross margin, we would be required to fund all debt service costs from available cash and sales of the First Defense® product line, which would reduce, and could eliminate, our expected profitability going forward and significantly reduce our cash flows.
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Uncertainty of market size and product sales estimates: Estimating the size of the total addressable market and future sales growth potential for our First Defense® product line is based on our experience and understanding of market dynamics but is inherently subjective. Estimating the size of the market for any new product, such as Re-Tain®, involves more uncertainties than do projections for established products. We do not know whether, or to what extent, our products will achieve, maintain or increase market acceptance and profitability. Some of the uncertainties surrounding Re-Tain® include the product’s effectiveness against currently prevalent pathogens, market acceptance, the effect of a premium selling price on market penetration, cost of manufacture, competition from new and existing products sold by substantially larger competitors with greater market reach and promotional resources and other risks described under “Product Risks” – “Sales risks pertaining to Re-Tain®” below. Since Re-Tain® is a novel approach to treating mastitis, there are many uncertainties with regards to how quickly and to what extent we can develop the subclinical mastitis treatment market. Our belief that polypeptide antimicrobial technology will be viewed positively (relative to traditional antibiotics), if realized, may offset some of these risks and result in better overall market acceptance.
Net deferred tax assets: The realizability of our net deferred tax assets is a subjective estimate that is contingent upon many variables. During the second quarter of 2018, we recorded a full valuation allowance against our net deferred tax assets that significantly increased our net loss in comparison to other periods. This non-cash expense could be reversed, and this valuation allowance could be reduced or eliminated, if warranted by our actual and projected profitability in the future. We will continue to assess the need for the valuation allowance each quarter.
Product Risks
Product risks generally: We set objectives for our products that we can achieve, but the achievement of such goals is not a sure thing. The sale of our products is subject to production, financial, efficacy, regulatory, competitive and other market risks. Elevated standards to achieve and maintain regulatory compliance required to sell our products continue to evolve. Failure to achieve acceptable biological yields from our production processes can materially increase our costs of goods sold and reduce our production output, leading to lower margins and an order backlog that could adversely affect our customer relationships and operating results. First Defense® is sold, and we expect Re-Tain® to be sold, at significant price premiums to competitive products. There is no assurance that we will continue to achieve market acceptance of the First Defense® product line, or achieve market acceptance of Re-Tain®, at a profitable price level or that we can continue to manufacture our products at a low enough cost to result in a sufficient gross margin to justify their continued manufacture and sale. As we bring Re-Tain® to market, these risks could be heightened by the additional uncertainties associated with introducing a new product requiring a shift in customer behavior.
Sales risks pertaining to Re-Tain®: Actual or prospective Re-Tain® customers may decide to discontinue, reduce or avoid usage of Re-Tain® due to the following risks:
1) A rejection of a tank of milk by a positive milk inhibitor test because too much of the milk in a bulk tank is comprised of milk from cows being treated with Re-Tain®, when tested randomly for inhibitors by a milk hauler.
2) A failed or stalled cheese tank occurs when our recommended on-farm limit of 3% to 5% of milk from cows being treated with Re-Tain® is exceeded or not effectively diluted through the milk transportation and collection system, if a cheese starter culture is used that is susceptible to Nisin.
3) Producers’ current practice generally is to treat only clinical mastitis, which has the visual indicator of abnormal milk. In order to gain market penetration for Re-Tain®, we will need to change that practice and increase awareness of the importance of treating subclinical disease. This will require the producers’ ability and willingness to diagnose without visual indicators. Users of Re-Tain® could have unsatisfactory treatment outcomes if they lack the equipment needed to measure and monitor somatic cell counts (SCC) of the herd or individual cows (for which data is needed). This risk limits our access to treatment cows because about 40% of farms do not presently access this kind of testing at the cow level, and thus are not good candidates for the use of Re-Tain®.
4) Lower than anticipated treatment cure rates could be experienced because the product is administered to cows that we would not identify as the best treatment candidates based on SCC data.
5) Lower than anticipated treatment cure rates could be experienced because the product is administered to cows that are infected with pathogens outside of our label claims.
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6) Off-label use of our product in cows infected with clinical mastitis before we have run the required studies and achieved a label claim extension for this disease state, resulting in negative treatment outcomes.
7) Producers either do not choose to use it or might use it improperly, rather than follow our label instructions to administer one dose after each of three consecutive milkings, or they may limit use within the herd to avoid the negative outcomes described above.
Reliance on sales of the First Defense® product line: We are reliant on the market acceptance of the First Defense® product line to generate product sales and fund our operations. Our business would not have been profitable during the years ended December 31, 2012, 2013, 2015 and 2016, during the nine-month periods ended September 30, 2017 or during the three-month periods ended March 31, 2019, December 31, 2020, June 30, 2021, September 30, 2021, December 31, 2021 and March 31, 2022 without the gross margin that we earned on sales of the First Defense® product line.
Concentration of sales: Sales of the First Defense® product line aggregated 99% and 98% of our total product sales during the six-month periods ended June 30, 2022 and 2021, respectively. Our primary customers for the majority of our product sales (92% and 88% during the six-month periods ended June 30, 2022, and 2021, respectively) are in the U.S. dairy and beef industries. Product sales to international customers, who are also in the dairy and beef industries, aggregated 8% and 12% of our total product sales during the six-month periods ended June 30, 2022, and 2021, respectively. Sales of the First Defense® product line aggregated 98% of our total product sales during both of the years ended December 31, 2021 and 2020. Our primary customers for the majority of our product sales (86% and 89% during the years ended December 31, 2021 and 2020, respectively) are in the U.S. dairy and beef industries. Product sales to international customers, who are also in the dairy and beef industries, aggregated 14% and 11% of our total product sales during the years ended December 31, 2021 and 2020, respectively. The concentration of our sales from one product into just two markets (the dairy and beef markets) is a risk to our business. The animal health distribution segment has been aggressively consolidating over the last few years with larger distributors acquiring smaller distributors. A large portion of our product sales (73% and 74% during the six-month periods ended June 30, 2022 and 2021, respectively, and 73% and 71% during the years ended December 31, 2021 and 2020, respectively) was made to two large distributors. A large portion of our trade accounts receivable (73% and 72% as of June 30, 2022 and December 31, 2021, respectively) was due from these two distributors. We have a good history with these distributors, but the concentration of sales and accounts receivable with a small number of customers does present a risk to us, including risks related to such customers experiencing financial difficulties or altering the basis on which they do business with us in a manner unfavorable to us.
Production capacity constraints: We invested approximately $3.6 million to increase our production capacity (in terms of annual sales dollars) for the First Defense® product line from approximately $16.5 million to approximately $23 million based on current selling prices and estimated production yields. During the fourth quarter of 2021, we reached this new, higher level of production output on an annualized basis. While this capacity expansion investment has proceeded very close to budget, there is a risk of cost overruns in our ongoing projects and any future production expansions that we may undertake, and a risk that we will not be able to achieve our production capacity growth objectives on a timely basis, resulting in a continuing or increasing shortfall in supply to the market. The inability to meet market demand for our products is a risk to our business. The historically large backlog of orders, as well as any ongoing order backlog, presents a risk that we could lose customers during this period that are not easily regained thereafter, when our production capacity is expected to meet or exceed sales demand. During the third quarter of 2021, we initiated additional investments to increase our annual production capacity for the First Defense® product line to approximately $35 million which we intend to complete by the end of 2022. We are making initial plans and investments to further increase our production capacity in 2024 and after. Our plan to continue to expand the First Defense® product line requires ongoing review of equipment capacity and utilization across the manufacturing value stream at the 56 Evergreen Drive facility and our leased facility at 175 Industrial Way, as well as assessment of functional obsolescence and reliability of equipment. This review and assessment could identify a need to fund unexpected equipment maintenance or replacement costs.
Product liability: The manufacture and sale of our products entails a risk of product liability. Our exposure to product liability is mitigated to some extent by the fact that our products are directed towards the animal health market. We have maintained product liability insurance in an amount which we believe is reasonable in relation to our potential exposure in this area. We have no history of claims of this nature being made.
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Regulatory Risks
Regulatory requirements for the First Defense® product line: First Defense® is sold in the United States subject to a product license from the Center for Veterinary Biologics, USDA, which was first obtained in 1991, with subsequent approvals of line extensions in 2017 and 2018. As a result, our operations are subject to periodic inspection by the USDA, and we are at risk of an unfavorable outcome from such inspections. The potency of serial lots is directly traceable to the original serial used to obtain the product performance claims (the Reference Standard). Due to the unique nature of the label claims, host animal re-testing is not required as long as periodic laboratory analyses continue to support the stability of stored Reference Standard. To date, these analyses have demonstrated strong stability. However, if the USDA were not to approve requalification of the Reference Standard, additional clinical studies could be required to meet regulatory requirements and allow for continued sales of the product, which could interrupt sales and adversely affect our operating results. Territories outside of the United States may require additional regulatory oversight that we may not be able to meet with our current facilities, processes and resources.
Regulatory requirements for Re-Tain®: The commercial introduction of this product in the United States requires us to obtain FDA approval. Completing the development through to approval of the NADA by the FDA involves risk. While four of the five required Technical Sections have been approved, the regulatory development process timeline has been extensive (approximately 14 years from the first FDA submission) and has involved multiple commercial production strategies and multiple submissions of the Chemistry, Manufacturing and Controls (CMC) Technical Section. Most recently, we received an Incomplete Letter from the FDA regarding this CMC Technical Section during the third quarter of 2022. The principal issue remaining is a successful pre-approval re-inspection of our manufacturing facility. We are completing preparations for such and intend to notify the FDA of our readiness for the re-inspection during the third quarter of 2022. Substantive issues that could have caused further significant delays did not appear in the FDA comments, indicating that they have been resolved to the FDA’s satisfaction. The other six comments (in addition to the comment requiring a successful pre-approval re-inspection) received appear not to be substantive and are not related to the safety or efficacy of the product. We intend to make our third submission of the CMC Technical Section in response to these questions during the third quarter of 2022. This clarifies the required path to product approval. To reduce the risk associated with this process, we are working with a qualified contract manufacturer (Norbrook) for alignment of the required validations and Drug Product manufacture (see discussion above) and have met with the FDA to clarify filing strategy and requirements. Our CMC Technical Section submission will be subject to a statutory six-month review period by the FDA. We believe we can successfully complete the pre-approval re-inspection inside of this time frame. Our efforts continue to be subject to inspection and approval by the FDA. There remains a risk that the required FDA approvals of our product and facilities could be delayed or not obtained. International regulatory approvals would be required for sales of Re-Tain® outside of the United States. Sales in these international territories would also be subject to milk discard and meat withhold restrictions.
Economic Risks Pertaining to the Dairy and Beef Industries
The industry data referred to below is compiled from USDA databases.
Cattle count: The January count of all cattle and calves in the United States had steadily declined from 97,000,000 as of January 1, 2007 to 88,500,000 as of January 1, 2014. Then this figure increased each year reaching 94,800,000 as of January 1, 2019 before declining to 93,800,000 as of both January 1, 2020 and January 1, 2021 and to 91,900,000 as of January 1, 2022. Reflecting seasonal trends, this figure was equal to 102,000,000, 101,000,000 and 98,800,000 as of July 1, 2020, 2021, and 2022, respectively.
Herd size: Prior to 1957, there were over 20,000,000 cows in the U.S. dairy herd. Prior to 1986, there were over 10,000,000 cows in the U.S. dairy herd. From 1998 through 2021, the size (annual average) of the U.S. dairy herd ranged from approximately the low of 9,011,000 in 2004 to the high of 9,448,000 in 2021. This average declined to 9,400,000 during the first half of 2022.
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ImmuCell Corporation
Milk price and feed costs: The dairy market, similar to many others, has been unstable as a result of the pandemic. The price paid to producers for milk has been very volatile. The Class III milk price (an industry benchmark that reflects the value of product used to make cheese) is an important indicator because it defines our customers’ revenue level. This annual average milk price level (measured in dollars per hundred pounds of milk) reached its highest point (since these prices were first reported in 1980) during 2014 at $22.34 (peaking at $24.60 in September 2014), which price level has never been repeated. During the year ended December 31, 2020, this average milk price was equal to $18.16, but it was extremely volatile during the year due largely to disruption in demand related to the COVID-19 pandemic. The one-month fluctuation of 73% from a low of $12.14 in May 2020 to $21.04 in June 2020 set an all-time record for variability. The average price for 2021 decreased by 6% to $17.08. With a significant jump to $22.52 during July, this price average increased by 34% to $22.89 during the first seven months of 2022. The annual fluctuations in this milk price level are demonstrated in the following table:
| Average Class III Milk Price During the Years Ended December 31, | (Decrease) Increase | |||||||
| 2014 | $ | 22.34 | ||||||
| 2015 | $ | 15.80 | (29 | %) | ||||
| 2016 | $ | 14.87 | (6 | %) | ||||
| 2017 | $ | 16.17 | 9 | % | ||||
| 2018 | $ | 14.61 | (10 | %) | ||||
| 2019 | $ | 16.96 | 16 | % | ||||
| 2020 | $ | 18.16 | 7 | % | ||||
| 2021 | $ | 17.08 | (6 | %) | ||||
The actual level of milk prices may be less important than its level relative to feed costs. One measure of this relationship is known as the milk-to-feed price ratio, which represents the amount of feed that one pound of milk can buy. An increase in feed costs also has a negative impact on the beef industry. This ratio varies farm-to-farm based on individual operating parameters. Since this ratio reached 3.24 in 2005, it has not exceeded 3.00. This ratio averaged 1.76 for 2021, amounting to a significant decline of 24% from the 2020 average of 2.31. This average has not been lower since 2013. During the first six months of 2022, this ratio improved by 16% to 2.04. The following table demonstrates the annual volatility and the low values of this ratio recently:
| Average Milk-To-Feed Price Ratio During the Years Ended December 31, | (Decrease) Increase | |||||||
| 2014 | 2.54 | |||||||
| 2015 | 2.14 | (16 | %) | |||||
| 2016 | 2.26 | 6 | % | |||||
| 2017 | 2.42 | 7 | % | |||||
| 2018 | 2.05 | (15 | %) | |||||
| 2019 | 2.25 | 10 | % | |||||
| 2020 | 2.31 | 3 | % | |||||
| 2021 | 1.76 | (24 | %) | |||||
Milk cow price: The all-time high value (annual average) for a milk cow was $1,993 during 2015. Since then, this annual average value steadily declined to $1,205 during 2019 before increasing to $1,300 during 2020 and to $1,363 during 2021. This average price for January and April of 2022 increased to an average of $1,475.
Market volatility: While the number of cows in the U.S. herd and the production of milk per cow directly influence the supply of milk, the price for milk is also influenced by very volatile international demand for milk products. Given our focus on the dairy and beef industries, the volatile market conditions and the resulting financial insecurities of our primary end users are risks to our ability to maintain and grow sales at a profitable level. These factors also heighten the challenge of selling premium-priced animal health products (such as Tri-Shield® and Re-Tain®) into the dairy market.
Small Size of Company
Dependence on key personnel: We are a small company with 71 employees (including 7 part-time employees). As such, we rely on certain key employees to support multiple operational functions, with limited redundancy in capacity. The loss of any of these key employees could adversely affect our operations until a qualified replacement is hired and trained, which could be even more challenging in the present very difficult labor market. Our competitive position will be highly influenced by our ability to attract, retain and motivate key scientific, manufacturing, managerial and sales and marketing personnel. With increased manufacturing staffing required to operate our expanded First Defense® production capacity and to operate our Re-Tain® production facility, we anticipate that our employment level could grow to approximately 80 employees during 2022. The cost of attracting and retaining the needed additional personnel in this current job market and inflationary environment could adversely affect our margins and profitability.
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Reliance on outside party to provide certain services under contract for us: We are exposed to additional regulatory compliance risks through the subcontractors that we choose to work with to produce Re-Tain®, who also need to satisfy certain regulatory requirements in order to provide us with the products and services we need. One example of this outside reliance is Norbrook, our Drug Product (DP) contract manufacturer. We face the risk of potential supply interruption and adverse effects on the market launch of Re-Tain® if we do not effectively manage the end of the DP supply provided from our contract manufacturer for orders scheduled for delivery during 2022 to align with the new supply from our own formulation and aseptic filling facility, which we currently expect to be operational by the second quarter of 2024. Because Norbrook has elected to terminate this supply agreement effective as of the end of 2022, we are investing approximately $4 million of the additional capital we raised during the first quarter of 2019 to construct and equip our own DP formulation and aseptic filling capability for Re-Tain® inside our existing Drug Substance facility. The objective of this investment is to end our reliance on an outside party to perform these services for us. Actual project costs could exceed our current estimates. Completion of this project could be delayed due to a number of factors outside our control, including delays in equipment fabrication, equipment delivery or facility construction. In addition, there is a risk that we fail to achieve regulatory approval of the new facility or that such approval is delayed or requires significant additional expenditures to obtain.
Competition from others: Many of our competitors are significantly larger and more diversified in the relevant markets than we are and have substantially greater financial, marketing, manufacturing and human resources and more extensive product development and sales/distribution capabilities than we do, including greater ability to withstand adverse economic or market conditions and declining revenues and/or profitability. Merck and Zoetis, among other companies, sell products that compete directly with the First Defense® product line in preventing scours in newborn calves. The scours product sold by Zoetis sells for approximately half the price of our product, although it does not have an E. coli claim (which ours does). With Tri-Shield®, we can now compete more effectively against vaccines that are given to the mother cow (dam) to improve the quality of the colostrum that she produces for the newborn calf. Elanco, Merck and Zoetis provide these dam vaccine products to the market. There are many companies competing in the mastitis treatment market, most notably Boehringer Ingelheim, Merck and Zoetis. The subclinical mastitis products sold by these large companies are well established in the market and are priced lower than what we expect for Re-Tain®, but all of them involve traditional antibiotics and are sold subject to a requirement to discard milk during and for a period of time after treatment (unlike our product which carries zero milk discard and zero milk withhold claims). There is no assurance that our products will compete successfully in these markets. We may not be aware of other companies that compete with us or intend to compete with us in the future.
Global Risks
Russia’s unprovoked military invasion of Ukraine: Russia’s unprovoked military invasion of Ukraine and attack on its people is having a significant negative impact on the world economy, worsening trends that were already moving in an unfavorable direction. Among other exposures, the increasing price of oil is already impacting our transportation-related expenses materially, and we expect this supply stress to increase the cost of petroleum-based products that we purchase (most plastics etc.). Further, the increasing cost of grain is a risk to our customers’ profitability.
Global COVID-19 pandemic (novel coronavirus, technically known as SARS-CoV-2): The global COVID-19 pandemic has created, and continues to create, uncertainty and challenges for us. The emergence of the Delta and Omicron variants and the resulting rising number of positive cases during the latter part of 2021 and into early 2022 has been a more recent concern. The COVID-19 pandemic has created or contributed to global supply-chain disruptions and has affected international trade, while creating a worldwide health and economic crisis. While presently there are some indications that suggest the situation may be improving, the full impact of this viral outbreak on the global economy, and the duration of such impact, remains very uncertain at this time. Stock market valuations have declined and recovered and remain volatile. Inflation has begun to increase significantly, and tax rates may increase. There is a risk of a period of economic downturn, the severity and duration of which are difficult to know. Prior to the pandemic and the responsive federal economic stimulus programs, many feared the United States had taken on too much national debt. Now the debt load is significantly higher. The dairy market, similar to many others, has been unstable as a result of the pandemic. The price paid to producers for milk has been very volatile. There is also economic uncertainty for beef producers, as the supply chain is interrupted or otherwise adversely affected due to closures of processing plants and reduced throughput caused by, among other things, restaurants closing or curtailing their operations. This is a very unusual situation for farmers that work so hard to improve production quality and efficiency in order to help feed a growing population with high-quality and cost-effective proteins. A combination of the conditions, trends and concerns summarized above could have a corresponding negative effect on our business and operations, including the supply of the colostrum we purchase to produce our First Defense® product line, the demand for our products in the U.S. market and our ability to penetrate or maintain a profitable presence in international markets. We are experiencing shortages in key components and needed products, backlogs and production slowdowns due to difficulties accessing needed supplies and labor and other restrictions which increase our costs and affect our ability to consistently deliver our products to market in a timely manner. Our exposure to this risk is mitigated to some extent by the fact that our supply chain is not heavily dependent on foreign manufacturers, by our on-going cross-training of our employees, by our implementation of remote work practices (where feasible) and by our early and continued compliance with recommended hygiene and social distancing practices. Despite our best efforts and intentions, there is a risk that an employee could become infected and could infect others.
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Bovine diseases: The potential for epidemics of bovine diseases such as Foot and Mouth Disease, Bovine Tuberculosis, Brucellosis and Bovine Spongiform Encephalopathy (BSE) presents a risk to us and our customers. Documented cases of BSE in the United States have led to an overall tightening of regulations pertaining to ingredients of animal origin, especially bovine. The First Defense® product line is manufactured from bovine milk (colostrum), which is not considered a BSE risk material. Future regulatory action to increase protection of the human food supply could affect the First Defense® product line, although presently we do not anticipate that this will be the case.
Risks Pertaining to Common Stock
Stock market valuation and liquidity: Our common stock trades on The Nasdaq Stock Market (Nasdaq: ICCC). Our average daily trading volume (which was approximately 7,517 shares per day during the twenty-day period ended August 2, 2022) is lower, our bid/ask stock price spread can be larger and our share price can be more volatile than what other companies experience, which could result in investors facing difficulty selling their stock for proceeds that they may expect or desire. Our share price as of August 2, 2022 was $9.05. Most companies in the animal health sector have market capitalization values that greatly exceed our current market capitalization of approximately $70 million as of August 2, 2022. Our product sales during the twelve-month period ended June 30, 2022 were $20 million. This means that our market valuation as of August 2, 2022 was equal to approximately 3.4 times our sales during the twelve-month period ended June 30, 2022. Before gross margin from the sale of new products is achieved, our market capitalization may be heavily dependent on the perceived potential for growth from our product under development and may therefore be negatively affected by the related uncertainties and risks.
Certain provisions might discourage, delay or prevent a change in control of our Company or changes in our management: Provisions of our certificate of incorporation, our bylaws, our Common Stock Rights Plan or Delaware law may discourage, delay or prevent a merger, acquisition or other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares of our common stock. These provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. These provisions include:
| ● | limitations on the removal of directors; |
| ● | advance notice requirements for stockholder proposals and nominations; |
| ● | the ability of our Board of Directors to alter or repeal our bylaws; |
| ● | the ability of our Board of Directors to refuse to redeem rights issued under our Common Stock Rights Plan or otherwise to limit or suspend its operation that would work to dilute the stock ownership of a potential hostile acquirer, potentially preventing acquisitions that have not been approved by our Board of Directors; and |
| ● | Section 203 of the Delaware General Corporation Law, which prohibits a publicly-held Delaware corporation from engaging in a business combination with an interested stockholder (generally defined as a person which together with its affiliates owns, or within the last three years has owned, 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder) unless the business combination is approved in a prescribed manner. |
The existence of the foregoing provisions and anti-takeover measures could depress the trading price of our common stock or limit the price that investors might be willing to pay in the future for shares of our common stock. They could also deter potential acquirers of our Company, thereby reducing the likelihood of obtaining a premium for our common stock in an acquisition.
No expectation to pay any dividends or repurchase stock for the foreseeable future: We do not anticipate paying any dividends to, or repurchasing stock from, our stockholders for the foreseeable future. Instead, we expect to use cash to fund product development costs and investments in our facilities and production equipment, and to increase our working capital and to reduce debt. Stockholders must be prepared to rely on market sales of their common stock after price appreciation to earn an investment return, which may never occur. Any determination to pay dividends in the future will be made at the discretion of our Board of Directors and will depend on our financial condition, results of operations, contractual restrictions, restrictions imposed by applicable laws, current and anticipated needs for liquidity and other factors our Board of Directors deems relevant.
Possible dilution: We may need to access the capital markets again and issue additional common stock in order to fund our growth objectives, as described elsewhere in this report. Such issuances could have a dilutive effect on our existing stockholders.
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ImmuCell Corporation
Other Risks
Access to raw materials and contract manufacturing services: Our objective is to maintain more than one source of supply for the components used to manufacture and test our products that we obtain from third parties. However, we are experiencing difficulty in efficiently acquiring essential supplies. We have significantly increased the number of farms from which we purchase colostrum for the First Defense® product line. A significant reduction in farm capacity could make it difficult for us to produce enough inventory to meet customer demand. The specific antibodies that we purify from colostrum for the First Defense® product line are not readily available from other sources. We are and will be dependent on our manufacturing facilities and operations in Portland for the production of the First Defense® product line and Re-Tain®. We are currently dependent on one manufacturer for the supply of the syringes used for our gel tube formats of Dual-Force First Defense® and Tri-Shield®. We are actively investigating a second supplier. We will be dependent on one other manufacturer for the supply of syringes for Re-Tain®. We are dependent on a contract with Norbrook for the Drug Product formulation and aseptic filling of our Nisin Drug Substance for orders scheduled for delivery in 2022. We expect to complete the investment to perform these services in-house during 2022 and achieve the required regulatory approval for use by the fourth quarter of 2023 or the second quarter of 2024. The facility we are constructing to perform these services in-house will be subject to FDA inspection and approval, the outcome and timing of which are not within our control. The potential alternative options for these services are narrowed considerably because our product cannot be formulated or filled in a facility that also processes traditional antibiotics (i.e., beta lactams). Any significant damage to or other disruption in the services at any of these third-party facilities or our own facilities (including due to regulatory issues or non-compliance) would adversely affect the production of inventory and result in significant added expenses and potential loss of future sales.
Failure to protect intellectual property: In some cases, we have chosen (and may choose in the future) not to seek patent protection for certain products or processes. Instead, we have sought (and may seek in the future) to maintain the confidentiality of any relevant proprietary technology through trade secrets, operational safeguards and contractual agreements. Reliance upon trade secret, rather than patent, protection may cause us to be vulnerable to competitors who successfully replicate (knock off) our manufacturing techniques and processes. Additionally, there can be no assurance that others may not independently develop similar trade secrets or technology or obtain access to our unpatented trade secrets or proprietary technology. Other companies may have filed patent applications and may have been issued patents involving products or technologies potentially useful to us or necessary for us to commercialize our products or achieve our business goals. If that were to be the case, there can be no assurance that we will be able to obtain licenses to such patents on terms that are acceptable to us. There is also a risk that competitors could challenge the claims in patents that have been issued to us.
Increasing dependence on the continuous and reliable operation of our information technology systems: We rely on information systems throughout our company. Any disruption of these systems or significant security breaches could adversely affect our business. Although we maintain information security policies and employ system backup measures and engage in information system redundancy planning and processes, such policies, measures, planning and processes, as well as our current disaster recovery plan may be ineffective or inadequate to address all eventualities. As information systems and the use of software and related applications by us, our business partners, suppliers, and customers become more cloud-based, we become inherently more susceptible to cyberattacks. There has been an increase in global cybersecurity vulnerabilities and threats, including more sophisticated and targeted cyber-related attacks that pose a risk to the security of our information systems and networks and the confidentiality, availability and integrity of data and information. There are reports of increased activity by hackers and scammers during the COVID-19 pandemic. Russia’s unprovoked military invasion of Ukraine may elevate the risk of such cyberattacks. Any such attack or breach could compromise our networks and the information stored thereon could be accessed, publicly disclosed, lost, or stolen. While we have invested in our data and information technology infrastructure (including working with an information security technology consultant to assess and enhance our security systems and procedures, and periodically training our employees in such systems and procedures), there can be no assurance that these efforts will prevent a system disruption, attack, or security breach and, as such, the risk of system disruptions and security breaches from a cyberattack remains. We have not experienced any material adverse effect on our business or operations as a consequence of any such attack or breach but may incur increasing costs in performing the tasks described above. Given the unpredictability of the timing, nature and scope of such disruptions and the evolving nature of cybersecurity threats, which vary in technique and sources, if we or our business partners or suppliers were to experience a system disruption, attack or security breach that impacts any of our critical functions, or our customers were to experience a system disruption, attack or security breach via any of our connected products and services, we could potentially be subject to production downtimes, operational delays or other detrimental impacts on our operations. Furthermore, any access to, public disclosure of, or other loss of data or information, including any of our (or our customers’ or suppliers’) confidential or proprietary information or personal data or information, as a result of an attack or security breach could result in governmental actions or private claims or proceedings, which could damage our reputation, cause a loss of confidence in our products and services, damage our ability to develop (and protect our rights to) our proprietary technologies and have a material adverse effect on our business, financial condition, results of operations or prospects. While this exposure is common to all companies, larger companies with greater resources may be better able to mitigate this risk than we can.
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ITEM 2 - UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None
ITEM 3 - DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4 - MINE SAFETY DISCLOSURES
None
ITEM 5 - OTHER INFORMATION
None
ITEM 6 – EXHIBITS
| Exhibit 4.1 | Amendment to Rights Agreement dated as of August 10, 2022. | |
| Exhibit 31 | Certifications required by Rule 13a-14(a). | |
| Exhibit 32 | Certification pursuant to Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
| 101.INS | XBRL Instance Document-the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document. | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | |
| 104 | Cover Page Interactive Data File-the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
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SIGNATURE
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| ImmuCell Corporation Registrant | |||
| Date: | August 11, 2022 | By: | /s/ Michael F. Brigham |
|
Michael F. Brigham President, Chief Executive Officer and Principal Financial Officer | |||
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51
Exhibit 4.1
ImmuCell Corporation
AMENDMENT TO RIGHTS AGREEMENT
THIS AMENDMENT is entered into as of August 10, 2022, between IMMUCELL CORPORATION, a Delaware corporation (the “Company”), and American Stock Transfer & Trust Co., a New York corporation, as Rights Agent (the “Rights Agent”).
WHEREAS, the Company and the Rights Agent are parties to (i) a Rights Agreement dated as of September 5, 1995, providing for the issuance of certain common stock purchase rights (the “Rights”) to holders of the Company’s outstanding Common Stock, (ii) an Amendment to the Rights Agreement, dated as of June 30, 2005, (iii) a second Amendment to Rights Agreement, dated as of June 30, 2008, (iv) a third Amendment to the Rights Agreement dated as of August 9, 2011 (v) a fourth Amendment to the Rights Agreement dated as of June 16, 2014, (vi) a fifth Amendment to the Rights Agreement dated as of April 15, 2015 and (vii) a sixth Amendment to the Rights Agreement dated as of August 10, 2017 (collectively, the “Rights Agreement”);
WHEREAS, under Section 7(a) of the Rights Agreement, the Rights terminate on or before the Final Expiration Date, defined in Section 1(a) of the Rights Agreement to be September 19, 2022; and
WHEREAS, the Company’s Board of Directors has determined that extending the Final Expiration Date for the Rights is in the best interest of the Company;
NOW, THEREFORE, in consideration of the mutual benefits arising herefrom, the parties hereto agree as follows:
| 1. | FINAL EXPIRATION DATE. Section 1(i) of the Rights Agreement is hereby amended to read in its entirety as follows: |
| “(i) “Final Expiration Date” shall mean the Close of Business on September 19, 2023.” |
| 2. | OTHER PROVISIONS. The “Summary of Rights to Purchase Common Stock” (attached to the Rights Agreement as Exhibit B thereto) shall likewise be deemed amended to reflect the change under Section 1 above. In all other respects, the terms and provisions of the Rights Agreement are hereby confirmed and shall remain in full force and effect, subject to the changes stated herein. |
Signature page to follow
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed and attested, all as of the date first above written.
| Attest: | IMMUCELL CORPORATION |
| By: | /s/ Elizabeth S. Toothaker | By: | /s/ Michael F Brigham | |
|
Elizabeth S. Toothaker Director of Finance and Administration |
Michael F. Brigham President and Chief Executive Officer |
| Attest: | AMERICAN STOCK TRANSFER & TRUST COMPANY, LLC |
| By: | /s/ Joseph Dooley | By: | /s/ Michael Legregin | |||
| Name: | Joseph Dooley | Name: | Michael Legregin | |||
| Title: | Senior Vice President | Title: | Senior Vice President, Corporate Actions Relationship Management & Operations | |||
Signature Page to Amendment to Rights Agreement
Exhibit 31
ImmuCell Corporation.
CERTIFICATIONS REQUIRED BY RULE 13a-14(a)
I, Michael F. Brigham, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of ImmuCell Corporation (the Company); |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report; |
| 4. | I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a- 15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Company and have: |
| a) | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the Company is made known to me by others within the Company, particularly during the period in which this report is being prepared; |
| b) | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c) | evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d) | disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the Company’s most recent fiscal quarter (the Company’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting; and |
| 5. | I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s Board of Directors (or persons performing the equivalent function): |
| a) | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and |
| b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting. |
Date: August 11, 2022
| /s/ Michael F. Brigham | |
| Michael F. Brigham | |
| President, Chief Executive Officer and Principal Financial Officer |
Exhibit 32
ImmuCell Corporation.
CERTIFICATION PURSUANT TO SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES- OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of ImmuCell Corporation (the “Company”) for the period ended June 30, 2022, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Michael F. Brigham, President, Chief Executive Officer and Principal Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
| (1) | the Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended (the “Exchange Act”); and |
| (2) | the information contained in the Report fairly presents, in all material respects, the financial condition, results of operations and cash flows of the Company. |
This certification is provided pursuant to 18 U.S.C. Section 1350 and Item 601(b)(32) of Regulation S-K (“Item 601(b)(32)”) promulgated under the Securities Act of 1933, as amended (the “Securities Act”), and the Exchange Act. In accordance with clause (ii) of Item 601(b)(32), this certification (A) shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, and (B) shall not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the Company specifically incorporates it by reference.
| /s/ Michael F. Brigham | |
| Michael F. Brigham | |
| President, Chief Executive Officer and Principal Financial Officer | |
| August 11, 2022 |
A signed original of this written statement required by Section 906 has been provided to ImmuCell Corporation and will be retained by ImmuCell Corporation and furnished to the Securities and Exchange Commission or its staff upon request.