Item 9A. Controls and Procedures
ITEM 9A
— 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 December 31, 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
Annual 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. This Annual 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.
Material Weakness
in Internal Controls over Financial Reporting : Management assesses the effectiveness of the Company’s internal control over
financial reporting at the end of each quarter. Based on this assessment, we concluded that our internal control over financial reporting
was not effective as of September 30, 2022, June 30, 2022 and March 31, 2022, because we identified one material weakness in the operation
(but not the design) of our internal controls over financial reporting during the first quarter of 2022 and a second one during the third
quarter of 2022. First, we did not accrue $222,000 of deferred compensation expense (consisting of earned and unused paid time off) during
the first quarter of 2022, which impacted the amount of our administrative expenses, accrued expenses and the related disclosures. Second,
we did not properly account for the extension of our lease agreement at 175 Industrial Way, which would have understated the value of
our operating lease right-of-use asset and operating lease liability by approximately $1,200,000 if the error had not been detected before
we issued our Quarterly Report on Form 10-Q for the three-month and nine-month periods ended September 30, 2022. These errors had no
impact on our product sales or cash position. We do believe that the design of our internal controls is effective, but the operating
effectiveness was not. We have implemented some changes to our internal controls over financial reporting, including documenting the
accounting for all contractual obligations in excess of $50,000 with accounting complexities in written memorandums to be reviewed by
a public accounting firm who is not our auditor or by another relevant consultant when the issues are complex in nature. As a result,
we have concluded that these material weaknesses over internal controls have been remediated as of December 31, 2022. Based on management’s
assessment, we believe that our internal controls over financial reporting were effective as of December 31, 2022.
Changes in Internal
Controls over Financial Reporting : Our principal executive and principal financial officer and our Director of Finance and Administration
periodically evaluate any change in internal control over financial reporting which has occurred during the prior fiscal quarter. We
have concluded that, with the exception of the enhanced internal control procedures discussed in the prior paragraph, there was no change
in our internal control over financial reporting that occurred during the three-month period or year ended December 31, 2022 that has
materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B
— OTHER INFORMATION
None
ITEM 9C
— DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
None
34
ImmuCell
Corporation
PART III
ITEM 10 — DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE
GOVERNANCE
Executive Officers of the Company
Our executive officers as of March 10, 2023 were
as follows:
MICHAEL F. BRIGHAM (Age: 62, Officer since
1991, Director since 1999) was appointed to serve as President and Chief Executive Officer in February 2000, while maintaining the titles
of Treasurer and Secretary, and was appointed to serve as a Director of the Company in March 1999. He previously had been elected Vice
President of the Company in December 1998 and had served as Chief Financial Officer since October 1991. He has served as Secretary since
December 1995 and as Treasurer since October 1991. Prior to that, he served as Director of Finance and Administration since originally
joining the Company in September 1989. Mr. Brigham served as a member of the Board of Directors of the United Way of York County from
2012 to 2019, serving as its Treasurer until June 2016 and as Chair of the Board of Directors for one year and as a member of its Executive
Committee. Mr. Brigham served as the Treasurer of the Board of Trustees of the Kennebunk Free Library from 2005 to 2011. He re-joined
the Finance Committee of the library in 2012. Prior to joining the Company, he was employed as an audit manager for the public accounting
firm of Ernst & Young. Mr. Brigham earned his Masters in Business Administration from New York University in 1989 and a Bachelor of
Arts degree (with a double major in Economics and Spanish) from Trinity College in Hartford, Connecticut in 1983.
BOBBI JO BROCKMANN (Age: 46, Officer since
February 2015, Director since January 2018) served as a Director of the Company from March 2017 to September 2017 and from January 2018
to the present. She was promoted to Vice President of Sales and Marketing in February 2015. She joined the Company as Director of Sales
and Marketing in January 2010. Prior to that, she had been employed as Director of Sales since May 2008 and Sales Manager from February
2004 to April 2008 at APC, Inc. of Ankeny, Iowa, a developer and marketer of functional protein products for animal health and nutrition.
Prior to that, she held other sales and marketing positions at APC, W & G Marketing Company, Inc. of Ames, Iowa, The Council
for Agricultural Science and Technology of Ames, Iowa and Meyocks Group Advertising of West Des Moines, Iowa after graduating from Iowa
State University.
ELIZABETH L. WILLIAMS (Age: 67, Officer since
April 2016) joined the Company in April 2016 as Vice President of Manufacturing Operations. Previously, she led the U.S. Region for Zoetis
as Vice President, Global Manufacturing and Supply. Prior to that, she held multiple Site Leader positions at Pfizer Animal Health facilities
in Lincoln, Nebraska (2008-2011), Conshohocken, Pennsylvania (2006-2008) and Lee’s Summit, Missouri (2003-2006). She led the manufacturing
organization (1999-2003) and the Process and Product Development group (1995-1999), achieving registration, approval and successful scale-up
of five new products at the Lee’s Summit facility. She earned her Masters of Business Administration from Rockhurst University in
Kansas City, Missouri and her Bachelor’s degree in Biology from the University of Missouri.
Information with respect to our directors is incorporated
herein by reference to the section of our 2023 Proxy Statement titled “Election of the Board of Directors”, which we intend
to file with the Securities and Exchange Commission within 120 days after December 31, 2022. There is no family relationship between any
director, executive officer, or person nominated or chosen by the Company to become a director or executive officer.
ITEM 11 — EXECUTIVE COMPENSATION
Information regarding compensation paid to our executive
officers is incorporated herein by reference to the section of our 2023 Proxy Statement titled “Executive Officer Compensation”,
which we intend to file with the Securities and Exchange Commission within 120 days after December 31, 2022.
ITEM 12 — SECURITY OWNERSHIP
OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Information regarding ownership of our common stock
by certain owners and management is incorporated herein by reference to the section of our 2023 Proxy Statement titled “Security
Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters”, which we intend to file with the Securities
and Exchange Commission within 120 days after December 31, 2022.
ITEM 13 — CERTAIN RELATIONSHIPS
AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
Information regarding certain relationships and
related transactions and director independence is incorporated herein by reference to the section of our 2023 Proxy Statement titled “Certain
Relationships and Related Transactions and Director Independence”, which we intend to file with the Securities and Exchange Commission
within 120 days after December 31, 2022.
ITEM 14 — PRINCIPAL ACCOUNTANT FEES AND SERVICES
Information regarding our principal accounting fees
and services is incorporated by reference to the section of our 2023 Proxy Statement titled “Principal Accounting Fees and Services”,
which we intend to file with the Securities and Exchange Commission within 120 days after December 31, 2022.
35
ImmuCell
Corporation
PART IV
ITEM 15 — EXHIBITS AND FINANCIAL
STATEMENT SCHEDULES
3.1
Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3.1 of the Company’s 1987 Registration Statement No. 33-12722 on Form S-1 as filed with the Commission).
3.2
Certificate of Amendment to the Company’s Certificate of Incorporation effective July 23, 1990 (incorporated by reference to Exhibit 3.2 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2008).
3.3
Certificate of Amendment to the Company’s Certificate of Incorporation effective August 24, 1992 (incorporated by reference to Exhibit 3.3 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2008).
3.4
Certificate of Amendment to the Company’s Certificate of Incorporation effective June 16, 2016 (incorporated by reference to Exhibit 3.1 of the Company’s Amended Current Report on Form 8-K/A filed on June 16, 2016).
3.5
Certificate of Amendment to the Company’s Certificate of Incorporation effective June 18, 2018 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed on June 18, 2018).
3.6
Certificate of Amendment to the Company’s Certificate of Incorporation effective June 11, 2020 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed on June 11, 2020).
3.7
Bylaws of the Company as amended (incorporated by reference to Exhibit 3.4 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2008).
4.1
Rights Agreement dated as of September 5, 1995, between the Company and American Stock Transfer and Trust Co., as Rights Agent, which includes as Exhibit A thereto the form of Right Certificate and as Exhibit B thereto the Summary of Rights to Purchase Common Stock (incorporated by reference to Exhibit 4.1 of the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2009).
4.1A
First Amendment to Rights Agreement dated as of June 30, 2005 (incorporated by reference to Exhibit 4.1A of the Company’s Current Report on Form 8-K filed on July 5, 2005).
4.1B
Second Amendment to Rights Agreement dated as of June 30, 2008 (incorporated by reference to Exhibit 4.1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2008).
4.1C
Third Amendment to Rights Agreement dated as of August 9, 2011 (incorporated by reference to Exhibit 4.1 of the Company’s Quarterly Report on Form 10-Q for the three-month period ended June 30, 2011).
4.1D
Fourth Amendment to Rights Agreement dated as of June 16, 2014 (incorporated by reference to Exhibit 4.1D of the Company’s Current Report on Form 8-K filed on June 17, 2014).
4.1E
Fifth Amendment to Rights Agreement dated as of April 15, 2015 (incorporated by reference to Exhibit 4.1 of the Company’s Quarterly Report on Form 10-Q for the three-month period ended March 31, 2015).
4.1F
Sixth Amendment to Rights Agreement dated as of August 10, 2017 (incorporated by reference to Exhibit 4.1 of the Company’s Quarterly Report on Form 10-Q for the three-month period ended June 30, 2017).
4.1G
Seventh Amendment to Rights Agreement dated as of August 10, 2022 (incorporated by reference to Exhibit 4.1 of the Company’s Amended Quarterly Report on Form 10-Q/A filed on November 21, 2022).
4.2
Description of Securities Registered Under Section 12 of the Securities Exchange Act of 1934, as amended (incorporated by reference to Exhibit 4.2 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020).
10.1+
Form of Indemnification Agreement (updated) entered into with each of the Company’s Directors and Officers (incorporated by reference to Exhibit 10.3A of the Company’s Annual Report on Form 10-KSB for the year ended December 31, 2006).
10.2+
Amendment to Employment Agreement between the Company and Michael F. Brigham dated March 26, 2010 (incorporated by reference to Exhibit 10.6 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2009).
10.3+
2010 Stock Option and Incentive Plan of the Company (incorporated by reference to Exhibit 10.6 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2010).
10.4+
Form of Incentive Stock Option Agreement (incorporated by reference to Exhibit 10.7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2010).
10.5+
2017 Stock Option and Incentive Plan of the Company (incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q for the three-month period ended June 30, 2017).
10.6+
Form of Incentive Stock Option Agreement (incorporated by reference to Exhibit 10.9 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019).
10.7+*
Amendment to the 2017 Stock Option and Incentive Plan of the Company.
10.8+
Second Amended and Restated Incentive Compensation Agreement between the Company and Elizabeth L. Williams dated as of March 28, 2022 (incorporated by reference to Exhibit 10.8 of the Company’s Annual Report on Form 10-K filed on March 30, 2022).
10.9+
Third Amended and Restated Incentive Compensation Agreement between the Company and Elizabeth L. Williams dated as of November 11, 2022 (incorporated by reference to Exhibit 10 to the Company’s Quarterly Report on Form 10-Q filed on November 21, 2022).
10.10+*
Fourth Amended and Restated Incentive Compensation Agreement between the Company and Elizabeth L. Williams dated as of March 28, 2023.
10.11+
Amended and Restated Separation and Deferred Compensation Agreement between the Company and Michael F. Brigham dated as of March 28, 2022 (incorporated by reference to Exhibit 10.9 of the Company’s Annual Report on Form 10-K filed on March 30, 2022).
36
ImmuCell
Corporation
10.12+
Incentive Compensation Agreement between the Company and Michael F. Brigham dated as of March 28, 2022 (incorporated by reference to Exhibit 10.10 of the Company’s Annual Report on Form 10-K filed on March 30, 2022).
10.13+*
Amended and Restated Incentive Compensation Agreement between the Company and Michael F. Brigham dated as of March 28, 2023.
10.14+
Second Amended and Restated Incentive Compensation Agreement between the Company and Bobbi Jo Brockmann dated as of March 28, 2022 (incorporated by reference to Exhibit 10.11 of the Company’s Annual Report on Form 10-K filed on March 30, 2022).
10.15+*
Third Amended and Restated Incentive Compensation Agreement between the Company and Bobbi Jo Brockmann dated as of March 28, 2023.
10.16
Development Services and Commercial Supply Agreement between the Company and Norbrook Laboratories Limited dated as of September 5, 2019 (incorporated by reference to Exhibit 99.2 of the Company’s Current Report on Form 8-K filed on September 11, 2019).
10.17
Indenture of Lease for Premises Located in Portland, Maine between the Company and TVP, LLC (incorporated by reference to Exhibit 99.2 of the Company’s Current Report on Form 8-K filed on September 17, 2019).
10.18
Second Amendment of Indenture of Lease for Premises Located in Portland, Maine between the Company and TVP, LLC dated as of August 15, 2022 (incorporated by reference to Exhibit 99.1 to the Company’s Current Report on Form 8-K filed on August 17, 2022).
10.19
Term Note for $5,100,000 between the Company and Gorham Savings Bank dated March 11, 2020 (incorporated by reference to Exhibit 99.2 of the Company’s Current Report on Form 8-K filed on March 12, 2020).
10.20
Loan Agreement for $5,100,000 between the Company and Gorham Savings Bank dated March 11, 2020 (incorporated by reference to Exhibit 99.4 of the Company’s Current Report on Form 8-K filed on March 12, 2020).
10.21
Term Note for $3,500,000 between the Company and Gorham Savings Bank dated March 11, 2020 (incorporated by reference to Exhibit 99.3 of the Company’s Current Report on Form 8-K filed on March 12, 2020).
10.22
Loan Agreement for $3,500,000 between the Company and Gorham Savings Bank dated March 11, 2020 (incorporated by reference to Exhibit 99.5 of the Company’s Current Report on Form 8-K filed on March 12, 2020).
10.23*
Allonge to and Amendment of Line of Credit Loan for up to $1,000,000 between the Company and Gorham Savings Bank dated March 23, 2022.
10.24
Note Purchase Agreement executed by the Company in favor of the Maine Technology Institute dated June 12, 2020 (incorporated by reference to Exhibit 99.2 of the Company’s Current Report on Form 8-K filed on June 16, 2020).
10.25
Subordinated Promissory Note for $500,000 executed by the Company in favor of the Maine Technology Institute dated June 12, 2020 (incorporated by reference to Exhibit 99.3 of the Company’s Current Report on Form 8-K filed on June 16, 2020).
10.26
Note Purchase Agreement executed by the Company in favor of the Maine Technology Institute dated June 30, 2021 (incorporated by reference to Exhibit 99.1 of the Company’s Current Report on Form 8-K filed on July 6, 2021).
10.27
Subordinated Promissory Note for $400,000 executed by the Company in favor of the Maine Technology Institute dated June 30, 2022 (incorporated by reference to Exhibit 99.2 of the Company’s Current Report on Form 8-K filed on July 6, 2021).
10.28
Term Note for $1,500,000 executed by the Company in favor of Gorham Savings Bank dated December 15, 2020 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on December 17, 2020).
10.29
Loan Agreement for $1,500,000 executed by the Company in favor of Gorham Savings Bank dated December 15, 2020 (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on December 17, 2020).
10.30
Allonge to and Amendment of Term Note, dated March 23, 2022, between the Company and Gorham Savings Bank (incorporated by reference to Exhibit 99.1 of the Company’s Current Report on Form 8-K filed on March 24, 2022).
10.31
Mortgage Modification Agreement, dated March 23, 2022, between the Company and Gorham Savings Bank (incorporated by reference to Exhibit 99.2 of the Company’s Current Report on Form 8-K filed on March 24, 2022).
14
Code of Business Conduct and Ethics (incorporated by reference to Exhibit 14 of the Company’s Current Report on Form 8-K filed on March 20, 2014).
23.1*
Consent of Independent Registered Public Accounting Firm.
24.1
Power of Attorney (incorporated by reference to the signature page of this Form 10-K).
31*
Certification Pursuant to Rule 13a-14(a).
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.
+ Management contract or compensatory plan or arrangement.
* Filed
herewith.
ITEM 16 – FORM 10-K SUMMARY
None
37
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of ImmuCell
Corporation
Opinion on the Financial Statements
We have audited the accompanying balance
sheets of ImmuCell Corporation (the “Company”) as of December 31, 2022 and 2021, and the related statements of operations,
stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2022, and the related notes (collectively
referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects,
the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each
of the two years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States
of America.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance
with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were
we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an
understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the
Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures
to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial
statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as
evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated
below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated
to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved
our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way
our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing
a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Valuation of Inventory
Description of the Matter At December 31, 2022, the Company’s inventory was $6,038,539.
As discussed in Note 2 of the financial statements, inventory is recorded at the lower of cost, or net realizable value.
Auditing management’s valuation of inventory is complex
and highly judgmental because of the estimates and assumptions used by management to determine the cost accounting and because of the
variability of the cost per dose due to fluctuations in the biological yield achieved.
How We Addressed the Matter
In Our Audit The primary procedures we performed to address this critical
audit matter included the following. We obtained an understanding of the
cost accounting developed by management and the related assumptions and estimates used. We tested the cost accounting by examining the
underlying data used by the Company to prepare the cost accounting. We evaluated the effect of the variability of the cost per dose on
the inventory value by comparing the biological yield to historical results and by performing a sensitivity analysis of the potential
range in inventory value within a corridor of historical results based on minimum and maximum outcomes for the biological yield.
/s/ WIPFLI LLP
We have served as the Company’s auditor since 2019.
Minneapolis, Minnesota
March 29, 2023
F- 1
ImmuCell Corporation
BALANCE SHEETS
As of December 31,
2022
2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 5,791,562
$ 10,185,468
Trade accounts receivable, net
1,758,600
2,694,229
Inventory
6,038,539
3,089,974
Prepaid expenses and other current assets
406,055
295,197
Total current assets
13,994,756
16,264,868
Property, plant and equipment, net
28,441,726
26,893,599
Operating lease right-of-use asset
2,194,670
1,109,133
Goodwill
95,557
95,557
Intangible assets, net
57,312
76,416
Other assets
76,628
26,115
TOTAL ASSETS
$ 44,860,649
$ 44,465,688
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Current portion of debt obligations
$ 1,039,447
$ 812,207
Current portion of operating lease liability
31,764
108,012
Accounts payable and accrued expenses
2,000,862
1,614,250
Total current liabilities
3,072,073
2,534,469
LONG-TERM LIABILITIES:
Debt obligations, net of current portion
9,191,109
8,327,122
Operating lease liability, net of current portion
2,217,418
1,027,157
Total long-term liabilities
11,408,527
9,354,279
TOTAL LIABILITIES
14,480,600
11,888,748
CONTINGENT LIABILITIES AND COMMITMENTS (See Note 11)
STOCKHOLDERS’ EQUITY:
Common stock, $ 0.10 par value per share, 15,000,000 shares authorized and
7,814,165 shares issued as of both December 31, 2022 and 2021 and
7,746,864 and 7,741,864 shares outstanding as of December 31, 2022 and
2021, respectively
781,417
781,417
Additional paid-in capital
35,978,364
35,692,388
Accumulated deficit
( 6,232,499 )
( 3,738,694 )
Treasury stock, at cost, 67,301 and 72,301 shares as of December 31, 2022 and 2021, respectively
( 147,233 )
( 158,171 )
Total stockholders’ equity
30,380,049
32,576,940
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 44,860,649
$ 44,465,688
The accompanying notes are an integral part
of these financial statements.
F- 2
ImmuCell Corporation
STATEMENTS OF OPERATIONS
During the Years Ended December 31,
2022
2021
Product sales
$ 18,567,962
$ 19,242,969
Costs of goods sold
10,919,183
10,587,040
Gross margin
7,648,779
8,655,929
Product development expenses
4,493,872
4,168,518
Sales and marketing expenses
3,190,033
2,503,926
Administrative expenses
2,263,817
1,726,100
Operating expenses
9,947,722
8,398,544
NET OPERATING (LOSS) INCOME
( 2,298,943 )
257,385
Other expenses, net
187,190
326,512
LOSS BEFORE INCOME TAXES
( 2,486,133 )
( 69,127 )
Income tax expense
7,672
9,165
NET LOSS
$ ( 2,493,805 )
$ ( 78,292 )
Basic weighted average common shares outstanding
7,745,122
7,592,290
Basic net loss per share
$ ( 0.32 )
$ ( 0.01 )
Diluted weighted average common shares outstanding
7,745,122
7,592,290
Diluted net loss per share
$ ( 0.32 )
$ ( 0.01 )
The accompanying notes are an integral part
of these financial statements.
F- 3
ImmuCell Corporation
STATEMENTS OF STOCKHOLDERS’ EQUITY
Common
Stock
Treasury
Stock
Shares
Amount
Additional
paid-in capital
Accumulated
Deficit
Shares
Amount
Total
Stockholders’
Equity
BALANCE,
December 31, 2020
7,299,009
$ 729,901
$ 31,372,093
$ ( 3,660,402 )
80,173
$ ( 175,392 )
$ 28,266,200
Net loss
—
—
—
( 78,292 )
—
—
( 78,292 )
Public offering of common stock, net of $ 17,011 of offering costs
515,156
51,516
4,181,510
—
—
—
4,233,026
Exercise of stock options
—
—
( 5,528 )
—
( 7,872 )
17,221
11,693
Stock-based compensation
—
—
144,313
—
—
—
144,313
BALANCE,
December 31, 2021
7,814,165
$ 781,417
$ 35,692,388
$ ( 3,738,694 )
72,301
$ ( 158,171 )
$ 32,576,940
Net loss
—
—
—
( 2,493,805 )
—
—
( 2,493,805 )
Exercise of stock options
—
—
19,732
—
( 5,000 )
10,938
30,670
Stock-based compensation
—
—
266,244
—
—
—
266,244
BALANCE,
December 31, 2022
7,814,165
$ 781,417
$ 35,978,364
$ ( 6,232,499 )
67,301
$ ( 147,233 )
$ 30,380,049
The accompanying notes are an integral part
of these financial statements.
F- 4
ImmuCell Corporation
STATEMENTS OF CASH FLOWS
During the Years Ended
December 31,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 2,493,805 )
$ ( 78,292 )
Adjustments to reconcile net loss to net cash (used for) provided by operating activities:
Depreciation
2,468,479
2,442,036
Amortization of intangible assets
19,104
19,104
Amortization of debt issuance costs
7,658
7,841
Stock-based compensation
266,244
144,313
(Gain) loss on disposal of property, plant and equipment
( 7,334 )
30,963
Non-cash rent expense
28,476
10,716
Changes in:
Trade accounts receivable
935,629
( 897,428 )
Accrued interest income
—
495
Inventory
( 2,948,565 )
( 997,460 )
Prepaid expenses and other current assets
( 110,858 )
26,064
Other assets
( 50,513 )
58
Accounts payable and accrued expenses
341,614
245,760
Net cash (used for) provided by operating activities
( 1,543,871 )
954,170
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property, plant and equipment
( 3,975,274 )
( 2,608,649 )
Maturities of investment
—
996,000
Proceeds from sale of property, plant and equipment
11,000
15,290
Net cash used for investing activities
( 3,964,274 )
( 1,597,359 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from public offering, net
—
4,233,026
Proceeds from debt issuance
2,000,000
400,000
Debt principal repayments
( 897,125 )
( 768,271 )
(Payments) net adjustments of debt issuance costs
( 19,306 )
2,272
Proceeds from exercise of stock options
30,670
11,693
Net cash provided by financing activities
1,114,239
3,878,720
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
( 4,393,906 )
3,235,531
BEGINNING CASH AND CASH EQUIVALENTS
10,185,468
6,949,937
ENDING CASH AND CASH EQUIVALENTS
$ 5,791,562
$ 10,185,468
The accompanying notes are an integral part
of these financial statements.
F- 5
ImmuCell Corporation
STATEMENT OF CASH FLOWS
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
During the Years Ended
December 31,
2022
2021
CASH PAID FOR:
Income taxes
$ 4,923
$ 5,110
Interest expense
$ 338,516
$ 308,682
NON-CASH ACTIVITIES:
Change in capital expenditures included in accounts payable and accrued expenses
$ ( 44,998 )
$ ( 18,263 )
Surrender of shares to exercise stock options
$ —
$ 165,337
Lease liability arising from obtaining right-of-use asset
$ 1,184,727
$ —
The accompanying notes are an integral part
of these financial statements.
F- 6
ImmuCell Corporation
Notes to Audited 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. A combination of the conditions, trends and concerns related to or arising from the global COVID-19
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. 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.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(a) Basis of Presentation
We have prepared the accompanying audited 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 $ 250,000
per financial institution per depositor. See Note 3.
(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 December 31, 2022 and 2021, we determined that no allowance for doubtful accounts was necessary. See Note 4.
(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.
F- 7
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
(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. The facility we have constructed at 33 Caddie
Lane to produce the Nisin Drug Substance for Re-Tain ® is being depreciated over 39 years from when a certificate
of occupancy was issued during the fourth quarter of 2017. We began depreciating the equipment for our Nisin Drug Substance facility when
it was placed in service during the third quarter of 2018. Approximately 87 % of these assets are being depreciated over 10 years. We began
depreciating the leasehold improvements to our new First Defense ® production facility at 175 Industrial Way over
the remainder of the 10 -year lease term beginning when a certificate of occupancy was issued during the second quarter of 2020. During
August of 2022, this lease term was extended to January of 2043 in connection with a new lease covering space at 165 Industrial Way. As
a result, the net book value of these leasehold improvements as of August 31, 2022 is now being depreciated over the remainder of the
extended lease term. Significant repairs to property, plant and equipment that benefit more than a current period are capitalized and
depreciated over their useful lives. Insignificant repairs are expensed when incurred. See Note 7.
(f) Leases
We account for our real estate leases using a
right-of-use model, which recognizes that at the date of commencement, a lessee has a financial obligation to make lease payments to the
lessor for the right to use the underlying asset during the lease term and recognizes a corresponding right-of-use (ROU) asset related
to this right. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the future
lease payments over the expected lease term. The ROU asset is also adjusted for any lease prepayments made, lease incentives received
and initial direct costs incurred. For operating leases with lease payments that fluctuate over the lease term, the total lease costs
are recognized on a straight-line basis over the lease term. Our leases, at times, may include options to extend the term of the lease.
When it is reasonably certain that we will exercise the option, we include the impact of the option in the lease term for purposes of
determining future lease payments. For all underlying classes of assets, we made an accounting policy election to not recognize assets
or liabilities for leases with a term of twelve months or less and to account for all components in a lease arrangement as a single combined
lease component. Short-term lease payments are recognized on a straight-line basis. Certain of our lease agreements include variable rent
payments, consisting primarily of amounts paid to the lessor based on cost or consumption, such as maintenance and real estate taxes.
These costs are recognized in the period in which the obligation is incurred. Because our leases do not specify an implicit rate, we use
an incremental borrowing rate based on information available at the lease commencement date to determine the present value of the lease
payments. We evaluate our right-of-use asset for impairment when events or changes in circumstances indicate that the carrying value of
the asset may not be recoverable. See Note 12.
(g) 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 the amounts paid in excess of fair
value of the net assets (including tax attributes) as goodwill, which is accounted for under the acquisition method of accounting. We
assess the impairment of intangible assets and goodwill that have indefinite lives (when applicable) at the reporting unit level on an
annual basis (as of December 31 st ) 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 years ended December 31, 2022 or 2021. See Notes 2(h) and 8 for additional disclosures.
F- 8
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
(h) Valuation of Long-Lived Assets
We periodically evaluate our long-lived assets,
consisting principally of property, plant and equipment, 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. No impairment was recognized during the years ended December 31, 2022 or
2021.
(i) 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 December 31,
2022 and 2021, the carrying amounts of cash and cash equivalents, accounts receivable, inventory, prepaid expenses and other current assets,
other assets, accounts payable and accrued expenses 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 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.
We also hold money market accounts in our bank 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 years ended December 31, 2022 and 2021, there were no transfers between levels. As of December 31, 2022 and 2021, our Level 1 assets
measured at fair value by quoted prices in active markets consisted of bank savings accounts and money market accounts. There were no
assets or liabilities measured at fair value on a nonrecurring basis as of December 31, 2022 and 2021. The carrying values of our cash
and money market accounts as of December 31, 2022 and 2021 and of our bank debt as of December 31, 2021 approximated their fair market
values. Due to inflation and the changing interest rate environment, the carrying value of our bank debt as of December 31, 2022 differed
from its fair market value. These values are reflected in the following tables:
As of December 31, 2022
Level 1
Level 2
Level 3
Total
Assets:
Cash and money market accounts
$ 5,791,562
$ —
$ —
$ 5,791,562
Liabilities:
Bank debt
$ —
$ 8,897,197
$ —
$ 8,897,197
F- 9
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
As of December 31, 2021
Level 1
Level 2
Level 3
Total
Assets:
Cash and money market accounts
$ 10,185,468
$ —
$ —
$ 10,185,468
Liabilities:
Bank debt
$ —
$ 9,139,329
$ —
$ 9,139,329
(j) 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 10 % or more of total product sales are detailed in the following table:
During the Years Ended
December 31,
2022
2021
Company A
40 %
46 %
Company B
33 %
28 %
Trade accounts receivable due from significant
customers amounted to the percentages of total trade accounts receivable as detailed in the following table:
As of
December 31, 2022
As of
December 31, 2021
Company A
41 %
38 %
Company B
28 %
34 %
Company C
12 %
*
* Amount is less than 10 %.
(k) Revenue Recognition
We recognize revenue in accordance with Codification
Topic 606, Revenue from Contracts with Customers (ASC 606) . 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 ships to a customer. Amounts due are typically paid approximately 30 days from the time control is transferred. Shipping
and handling costs associated with outbound freight 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. See Note 14 for additional disclosures.
F- 10
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
(l) 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. All product development expenses are expensed as incurred, as are all related patent costs. We
capitalize costs to produce inventory during the production cycle, and these costs are charged to costs of goods sold when the inventory
is sold to a customer or is deemed to be in excess or obsolete.
(m) 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 it is more likely than not that we will 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 it is more likely
than not that we will not 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 2019. We have evaluated the positions taken on
our filed tax returns and have concluded that no uncertain tax positions existed as of December 31, 2022 or 2021. Although we believe
that our estimates are reasonable, actual results could differ from these estimates. See Note 16.
(n) 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 $ 266,244 and $ 144,313 during the years ended December 31, 2022 and 2021, respectively. See Note 13.
(o) Net Loss Per Common Share
Net loss per common share has been computed in
accordance with Codification Topic 260-10, Earnings Per Share . 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 605,000 and 443,000 during
the years ended December 31, 2022 and 2021, respectively.
During the Years Ended
December 31,
2022
2021
Net loss attributable to stockholders
$ ( 2,493,805 )
$ ( 78,292 )
Weighted average common shares outstanding - Basic
7,745,122
7,592,290
Dilutive impact of share-based compensation awards
—
—
Weighted average common shares outstanding - Diluted
7,745,122
7,592,290
Net loss per share:
Basic
$ ( 0.32 )
$ ( 0.01 )
Diluted
$ ( 0.32 )
$ ( 0.01 )
F- 11
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
(p) 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.
(q) New Accounting Pronouncements Adopted
Effective January 1, 2021, we adopted 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. The adoption of ASU 2019-12 did not
have a material impact on our financial statements.
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, was available to companies during the period from March 12, 2020 through December 31, 2022. The discontinuation of LIBOR did
not have a material impact on our financial statements.
(r) New Accounting Pronouncement Not Yet Adopted
In June 2016, the FASB issued ASU 2016-13, Financial
Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which is effective for us as of January
1, 2023, using the modified retrospective transition method. This ASU amends the impairment model to utilize an expected loss methodology
in place of the incurred loss methodology for financial instruments, including trade receivables and leased equipment. The amendment requires
entities to consider a broader range of information to estimate expected credit losses, which may result in earlier recognition of losses.
Historically, we have experienced a very low level of bad debt expense, and most of our trade receivables are collected by the due date
or within a few days of the due date. Because of this experience, we do not expect the adoption of ASU 2016-13 to have a material impact
on our financial statements.
3. CASH AND CASH EQUIVALENTS
Cash and cash equivalents amounted to $ 5,791,562
and $ 10,185,468 as of December 31, 2022, and 2021, respectively.
4. TRADE ACCOUNTS RECEIVABLE, net
Trade accounts receivable amounted to $ 1,758,600 ,
$ 2,694,229 and $ 1,796,801 as of December 31, 2022, 2021 and 2020, respectively. No allowance for bad debt or product returns was recorded
as of December 31, 2022, 2021 or 2020. The trade accounts receivable balances include $ 46,426 and $ 55,490 due from a related party as
of December 31, 2022 and 2021, respectively. See Note 18.
5. INVENTORY
Inventory consisted of the following:
As of
December 31, 2022
As of
December 31, 2021
Raw materials
$ 2,419,982
$ 971,606
Work-in-process
3,468,702
1,902,299
Finished goods
149,855
216,069
Total
$ 6,038,539
$ 3,089,974
These inventory figures are net of a $ 587,620
write-off of scrapped inventory that resulted principally from a contamination event in our production process around the end of the third
quarter of 2022.
F- 12
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
6. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets consisted
of the following:
As of
December 31, 2022
As of
December 31, 2021
Prepaid expenses
$ 363,877
$ 268,713
Other receivables
42,178
26,484
Total
$ 406,055
$ 295,197
7. PROPERTY, PLANT AND EQUIPMENT, net
Property, plant and equipment consisted of the following:
Estimated
Useful Lives
(in years)
As of
December 31, 2022
As of
December 31, 2021
Laboratory and manufacturing equipment
3 - 10
$ 19,181,960
$ 17,388,757
Buildings and improvements
10 - 39
20,050,167
19,119,698
Office furniture and equipment
3 - 10
900,306
869,191
Construction in progress
n/a
3,668,046
2,992,359
Land
n/a
516,867
516,867
Property, plant and equipment, gross
44,317,346
40,886,872
Accumulated depreciation
( 15,875,620 )
( 13,993,273 )
Property, plant and equipment, net
$ 28,441,726
$ 26,893,599
As of December 31, 2022 and 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 $ 127,127 and $ 160,366 during the years ended December 31, 2022 and 2021, respectively. Depreciation expense was $ 2,468,479 and $ 2,442,036
during the years ended December 31, 2022 and 2021, respectively.
8. INTANGIBLE ASSETS
Intangible assets of $ 191,040 were valued using
the relief from royalty method and are being amortized to costs of goods sold over their useful lives, which are estimated to be 10 years.
Intangible amortization expense was $ 19,104 during both of the years ended December 31, 2022 and 2021. The net value of these intangibles
was $ 57,312 and $ 76,416 as of December 31, 2022 and 2021, respectively. Intangible asset amortization expense is estimated to be $19,104
per year through December 31, 2025.
Intangible assets as of December 31, 2022 consisted
of the following:
Gross Carrying Value
Accumulated Amortization
Net Book
Value
Developed technology
$ 184,100
$ ( 128,870 )
$ 55,230
Customer relationships
1,300
( 910 )
390
Non-compete agreements
5,640
( 3,948 )
1,692
Total
$ 191,040
$ ( 133,728 )
$ 57,312
Intangible assets as of December 31, 2021 consisted
of the following:
Gross Carrying Value
Accumulated Amortization
Net Book
Value
Developed technology
$ 184,100
$ ( 110,460 )
$ 73,640
Customer relationships
1,300
( 780 )
520
Non-compete agreements
5,640
( 3,384 )
2,256
Total
$ 191,040
$ ( 114,624 )
$ 76,416
F- 13
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
9. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consisted
of the following:
As of
December 31, 2022
As of
December 31, 2021
Accounts payable – trade
$ 726,736
$ 726,781
Accounts payable – capital
63,261
18,263
Accrued payroll
966,553
585,939
Accrued professional fees
95,550
82,050
Accrued other
143,872
199,076
Income tax payable
4,890
2,141
Total
$ 2,000,862
$ 1,614,250
10. BANK DEBT
During the first quarter of 2020, we closed on
a debt financing with Gorham Savings Bank (GSB) aggregating $ 8,600,000 and a $ 1,000,000 line of credit. The debt was comprised of a $ 5,100,000
mortgage note (Loan #1) that bears interest at a fixed rate of 3.50 % per annum (with a 10 -year term and 25 -year amortization schedule
and a balloon principal payment of $ 3,145,888 due during the first quarter of 2030) and a $ 3,500,000 note (Loan #2) that bears interest
at a fixed rate of 3.50 % per annum (with a 7 -year term and amortization schedule). The line of credit is available as needed through March
11, 2024. Interest on borrowings against the line of credit is variable at the National Prime Rate per annum. There was no outstanding
balance under this line of credit as of December 31, 2022 or 2021. The proceeds from the debt refinancing were used to repay all bank
debt outstanding at the time of closing and to provide some additional working capital. During the fourth quarter of 2020, we closed on
a $ 1,500,000 note with GSB (Loan #4) that bears interest at a fixed rate of 3.50 % per annum (with a 7 -year term and amortization schedule).
Proceeds of $ 624,167 were used to prepay a portion of the outstanding principal on our mortgage note (Loan #1), which reduced the outstanding
balance to 80 % of the most recent appraised value of the property securing the debt, which allowed GSB to release the $ 1,400,000 that
had been held in escrow. This resulted in no change in the balloon principal payment of $3,145,888 due during the first quarter of 2030.
The remaining proceeds were available for general working capital purposes. During the first quarter of 2022, we closed on an additional
$ 2,000,000 in mortgage debt, which bears interest at the fixed rate of 3.58 % per annum. This was accomplished through an amendment of
the original mortgage note (Loan #1) that increased the then outstanding principal balance from $ 4,233,957 to $ 6,233,957 bearing interest
at the blended fixed rate of 3.53 % per annum. This increased the balloon payment from $ 3,145,888 to $ 3,687,348 and extended the due date
of the balloon payment from the first quarter of 2030 to the first quarter of 2032. In connection with these credit facilities, we incurred
aggregate debt issuance costs of $ 70,170 ($ 19,306 of which was incurred during 2022). The amortization of these debt issuance costs is
being recorded as a component of interest expense, included in other expenses, net, and is being amortized over the underlying terms of
the notes. These three credit facilities are secured by liens on substantially all of our assets and are subject to certain restrictions
and financial covenants. Given the funds we raised through an equity issuance in April 2021, GSB waived the minimum debt service coverage
(DSC) ratio requirement of 1.35 for the year ended December 31, 2021. By negotiation with GSB in connection with the 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. By subsequent
negotiation with GSB, compliance with the required minimum DSC ratio was waived for the year ended December 31, 2022. During the first
quarter of 2023, the DSC ratio covenant for the year ending December 31, 2023 was waived by GSB. Instead, we are required to meet a minimum
DSC ratio requirement of 1.35 for the twelve-month periods ending June 30, 2024, September 30, 2024 and December 31, 2024 and then again
annually after that.
During the second quarter of 2020, we received
a loan from the Maine Technology Institute (MTI) (Loan #3) in the aggregate principal amount of $ 500,000 . The first 2.25 years of this
loan were interest-free with no interest accrual or required principal payments. Beginning during the fourth quarter of 2022, Loan #3
became subject to quarterly principal and interest payments at a fixed rate of 5% per annum over the final five years of the loan, through
the third quarter of 2027 if not repaid before then. On June 30, 2021, we executed definitive agreements covering a second loan from the
MTI (Loan #5) in the aggregate principal amount of $400,000, proceeds from which were received in July 2021. The first two 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 5.5 years of the loan, beginning during the third quarter of 2023 and continuing through the
fourth quarter of 2028 if not repaid before then. These credit facilities are unsecured and subordinated to our indebtedness to GSB. Failure
to make timely payments of principal and interest, or otherwise to comply with the terms of the agreements with the MTI, would entitle
the MTI to accelerate the maturity of such debt and demand repayment in full. These loans may be prepaid without penalty at any time.
F- 14
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
Debt proceeds received and principal repayments
made during the years ended December 31, 2022 and 2021 are reflected in the following table by period and by loan:
During the Year
Ended December 31, 2022
During the Year
Ended December 31, 2021
Proceeds from Debt
Issuance
Debt Principal
Repayments
Proceeds from Debt Issuance
Debt Principal
Repayments
Loan #1
$ 2,000,000
$ ( 199,013 )
$ —
$ ( 115,860 )
Loan #2
—
( 477,237 )
—
( 460,637 )
Loan #3
—
( 22,160 )
—
—
Loan #4
—
( 198,715 )
—
( 191,774 )
Loan #5
—
—
400,000
—
Total
$ 2,000,000
$ ( 897,125 )
$ 400,000
$ ( 768,271 )
Principal payments (net of debt issuance costs)
due under bank loans outstanding as of December 31, 2022 (excluding our $ 1,000,000 line of credit) are reflected in the following table
by the year that payments are due:
During the Years Ending December 31,
2023
2024
2025
2026
2027
Thereafter
Total
Loan #1
$ 223,341
$ 230,891
$ 239,876
$ 248,604
$ 257,649
$ 4,864,766
$ 6,065,127
Loan #2
494,441
512,102
530,738
549,881
140,474
—
2,227,636
Loan #3
91,446
96,104
101,001
106,146
83,143
—
477,840
Loan #4
205,878
213,217
220,994
228,965
240,458
—
1,109,512
Loan #5
32,017
66,470
69,856
73,415
77,156
81,086
400,000
Subtotal
1,047,123
1,118,784
1,162,465
1,207,011
798,880
4,945,852
10,280,115
Debt issuance costs
( 7,676 )
( 7,267 )
( 7,168 )
( 7,168 )
( 5,420 )
( 14,860 )
( 49,559 )
Total
$ 1,039,447
$ 1,111,517
$ 1,155,297
$ 1,199,843
$ 793,460
$ 4,930,992
$ 10,230,556
11. CONTINGENT LIABILITIES AND COMMITMENTS
Our bylaws, as amended, in effect provide that the
Company will indemnify its officers and directors against any liability arising from their responsibilities as officers and directors
to the maximum extent permitted by Delaware law. In addition, we make similar indemnity undertakings with 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 December 31, 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 believe 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 December 31, 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.
F- 15
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
Effective March 28, 2022, the Company entered into
an Amended and Restated Separation and Deferred Compensation Agreement (the “Deferred Compensation Agreement”) with Mr. Brigham,
its President and CEO, that superseded and replaced in its entirety a March 2020 severance agreement between the Company and Mr. Brigham.
Upon separation from the Company for any reason, Mr. Brigham’s Deferred Compensation Agreement allows Mr. Brigham to be paid, among
other amounts, all earned and unused paid time off (which amount totaling $222,000 was accrued during the first quarter of 2022 and included
in accounts payable and accrued expenses on the accompanying balance sheet as of December 31, 2022) and to receive up to an additional
$300,000 in deferred compensation (which amount is being accrued over the three-year period ending in January 2025). This deferred compensation
payment vested as to $100,000 on January 1, 2023, and will vest as to an additional $100,000 on each of January 1, 2024 and January 1,
2025, provided that Mr. Brigham is employed by the Company on these future vesting dates. The vested amounts would be paid upon the earlier
of January 31, 2025 or within thirty (30) days following his separation from the Company. This amount is being accrued over the three-year
period ending in January 2025. As of December 31, 2022, $100,000 was included as part of accounts payable and accrued expenses on the
accompanying balance sheet. In addition, upon termination of Mr. Brigham’s employment (a) by the Company other than for cause, (b)
due to death or disability or (c) by Mr. Brigham for good reason, in each case as described and defined in the Deferred Compensation Agreement,
the Company agrees to pay Mr. Brigham 100% of his then current annual base salary and a lump sum payment equal to the employer portion
of the costs of continued health benefits for Mr. Brigham and his covered dependents for a twelve-month period following termination,
and certain equity incentive awards granted to Mr. Brigham would continue to vest following such termination in accordance with the terms
of the Deferred Compensation Agreement.
We generally enter into incentive compensation agreements
with our three executive officers annually. These agreements, which are publicly filed, with Mr. Brigham (our President and CEO), Ms.
Brockmann (our Vice President of Sales and Marketing) and Ms. Williams (our Vice President of Manufacturing Operations) allowed them to
earn incentive compensation if certain regulatory and financial objectives were met during the years ended December 31, 2022 and 2021,
as specified in their agreements. Similar agreements have been entered into and filed with these executive officers for the year ending
December 31, 2023. Amounts related to these incentive compensation agreements are accrued over the period they are earned (when it is
probable that the amounts will be earned) based on our best estimate of the amounts expected to be earned.
In addition
to the commitments discussed above, we had committed $ 294,000 to increase our production capacity for the First Defense ®
product line, $ 129,000 to construct and equip our own Drug Product formulation and aseptic filling facility for Re-Tain ® ,
$ 1,881,000 to the purchase of inventory, $ 134,000 to other capital expenditures and $ 401,000 to other obligations as of December 31, 2022.
12. OPERATING LEASE
On September 12, 2019, we entered into a lease
covering approximately 14,300 square feet of office and warehouse space with a possession date of November 15, 2019 and a commencement
date of February 13, 2020. The property is located at 175 Industrial Way in Portland, which is a short distance from our headquarters
and manufacturing facility at 56 Evergreen Drive. We renovated this space to meet our needs in expanding our production capacity for the
First Defense ® product line. The original lease term was ten years with a right to renew for a second 10-year term
and a right of first offer to purchase. At the time we entered into this lease, we were not reasonably assured that we would exercise
this renewal option in place of other real estate options. For that reason, a 10-year period was reflected in the right-of-use (ROU) asset
and lease liability on our balance sheet. During the third quarter of 2022, we committed to lease an additional 15,400 square feet of
space at 165 Industrial Way, which is connected to the original space at 175 Industrial Way, over a 20-year term. The ROU asset and lease
liability for the committed space to be leased at 165 Industrial Way will be recorded upon the commencement date of the new lease, which
is anticipated during the second quarter of 2023 after construction of the building shell is completed. In connection with the lease commitment
for space at 165 Industrial Way, the term of the original lease for 175 Industrial Way was extended by approximately 13 years. The total
lease liability over the amended term (including inflationary adjustments) aggregates $2,247,978. Our lease includes variable non-lease
components. Such payments primarily include common area maintenance charges. The balance of the operating lease ROU asset was $ 2,194,670
and the operating lease liability was $ 2,249,182 as of December 31, 2022. The calculated amount of the ROU asset and lease liability is
impacted by the length of the lease term and the discount rate used for the present value of the minimum lease payments. We elected not
to separate lease and non-lease components for all classes of underlying assets, and instead to account for them as a single lease component.
Variable lease cost primarily represents variable payments such as real estate taxes and common area maintenance. The following tables
describe our lease costs and other lease information:
During the Years Ended
December 31,
2022
2021
Lease Cost
Operating lease cost
$ 149,176
$ 117,996
Variable lease cost
36,404
41,400
Total lease cost
$ 185,580
$ 159,396
Operating Lease
Cash paid for operating lease liabilities
$ 148,302
$ 159,396
Weighted average remaining lease term (in years)
20.1
8.1
Weighted average discount rate
5.54 %
4.77 %
F- 16
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
Future lease payments required under non-cancelable operating leases
in effect as of December 31, 2022 were as follows:
Amount
During the years ending December
31,
2023
$ 155,730
2024
162,384
2025
165,090
2026
168,395
2027
171,760
Thereafter
3,049,071
Total lease payments (undiscounted cash flows)
3,872,430
Less: imputed interest (discount effect of cash flows)
( 1,623,248 )
Total operating liabilities
$ 2,249,182
13. STOCKHOLDERS’ EQUITY
Common Stock Issuances
From February 2016 to April 2021, we sold the
aggregate of 4,553,017 shares of common stock in six different transactions raising gross proceeds of approximately $ 26,714,000 at the
weighted average price of $ 5.87 per share. These funds have been essential to funding our business growth plans. The details of each transaction
are discussed below.
1) During February of 2016, we sold 1,123,810 shares
of common stock at a price to the public of $ 5.25 per share in an underwritten public offering pursuant to our effective shelf registration
statement on Form S-3, raising gross proceeds of approximately $ 5,900,000 and resulting in net proceeds to the Company of approximately
$ 5,313,000 (after deducting underwriting discounts and offering expenses incurred in connection with the equity financing).
2) During October of 2016, we sold, in a private
placement, 659,880 shares of common stock to nineteen institutional and accredited investors at $ 5.25 per share, raising gross proceeds
of approximately $ 3,464,000 and resulting in net proceeds to the Company of approximately $ 3,161,000 (after deducting placement agent
fees and other expenses incurred in connection with the equity financing).
3) During July of 2017, we sold 200,000 shares of
our common stock at a price of $ 5.25 per share in a public, registered sale to two related investors pursuant to our effective shelf registration
statement on Form S-3, raising gross proceeds of $ 1,050,000 and resulting in net proceeds of approximately $ 1,034,000 (after deducting
expenses incurred in connection with the equity financing).
4) During December of 2017, we sold 417,807 shares
of common stock at a price to the public of $ 7.30 per share in an underwritten public offering pursuant to our effective shelf registration
statement on Form S-3, raising gross proceeds of approximately $ 3,050,000 and resulting in net proceeds to the Company of approximately
$ 2,734,000 (after deducting underwriting discounts and offering expenses incurred in connection with the equity financing).
5) During March of 2019, we sold 1,636,364 shares
of common stock at a price to the public of $ 5.50 per share in an underwritten public offering pursuant to our effective shelf registration
statement on Form S-3, raising gross proceeds of approximately $ 9,000,000 and resulting in net proceeds to the Company of approximately
$ 8,303,000 (after deducting underwriting discounts and offering expenses incurred in connection with the equity financing).
6) During April of 2021, we sold 515,156 shares
of our common stock at a price of $ 8.25 per share in a public, registered sale to seven investors pursuant to our effective shelf registration
statement on Form S-3, raising gross proceeds of approximately $ 4,250,000 and resulting in net proceeds of approximately $ 4,233,000 (after
deducting expenses incurred in connection with the equity financing).
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, 300,000 shares of common stock were reserved for issuance under the 2010 Plan and
subsequently no additional shares have been reserved for the 2010 Plan. Vesting requirements are determined by the Compensation and Stock
Option Committee of the Board of Directors on a case-by-case basis. All options granted under the 2010 Plan expire no later than 10 years
from the date of grant. The 2010 Plan expired in June 2020, after which date no further options can be granted under the 2010 Plan. However,
options outstanding under the 2010 Plan at that time can be exercised in accordance with their terms. As of December 31, 2022, there were
202,500 options outstanding under the 2010 Plan.
F- 17
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
In June 2017, our stockholders approved the 2017
Stock Option and Incentive Plan (the “2017 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, 300,000 shares of common stock were reserved for issuance under the 2017 Plan. An
amendment to the 2017 Plan increasing the number of shares reserved for issuance under the 2017 Plan from 300,000 shares to 650,000 shares
was approved by a vote of stockholders at the Annual Meeting of Stockholders in June 2022. Vesting requirements are determined by the
Compensation and Stock Option Committee of the Board of Directors on a case-by-case basis. All options granted under the 2017 Plan expire
no later than 10 years from the date of grant. The 2017 Plan expires in March 2027, after which date no further options can be granted
under the 2017 Plan. However, options outstanding under the 2017 Plan at that time can be exercised in accordance with their terms. As
of December 31, 2022, there were 402,500 options outstanding under the 2017 Plan.
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
237,500
176,500
$ 6.38
$ ( 180,038 )
Grants
—
86,000
$ 9.78
Terminations/forfeitures (2)
( 12,000 )
( 20,000 )
$ 7.26
Exercises
( 7,000 )
( 18,000 )
$ 7.08
Outstanding as of December 31, 2021
218,500
224,500
$ 6.94
$ 468,425
Grants
—
210,500
$ 7.73
Terminations/forfeitures (2)
( 11,000 )
( 32,500 )
$ 7.34
Exercises
( 5,000 )
—
$ 6.13
Outstanding as of December 31, 2022
202,500
402,500
$ 7.19
$ ( 661,310 )
Vested as of December 31, 2022
184,500
113,500
$ 6.66
$ ( 165,575 )
Vested and expected to vest as of December 31, 2022
202,500
402,500
$ 7.19
$ ( 661,310 )
Reserved for future grants
—
229,500
(1) Intrinsic value is the difference between the fair market value
of the underlying common stock as of the date indicated and as of the date of the option grant (which is equal to the option exercise
price).
(2) Terminations and forfeitures are recognized when they occur.
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
160,000
$ 3.36
$ 7.23
Non-vested stock options as of December 31, 2022
307,000
$ 3.80
$ 7.71
Stock options granted during the year ended December 31, 2022
210,500
$ 4.03
$ 7.73
Stock options that vested during the year ended December 31, 2022
31,000
$ 2.79
$ 5.35
Stock options that were terminated or forfeited during the year ended December 31, 2022
43,500
$ 4.00
$ 7.34
During the year ended December 31, 2022, one
former employee and two employees exercised stock options covering 5,000 shares with $ 30,670 in cash. During the year ended December 31,
2021, one director and three employees exercised stock options covering 25,000 shares by the surrender of 17,128 shares of common stock
with a fair market value of $165,337 at the time of exercise and the payment of $11,693 in cash.
F- 18
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
The weighted average remaining life of the options
outstanding under the 2010 Plan and the 2017 Plan as of December 31, 2022 was approximately 5 years and 2 months. The weighted average
remaining life of the options exercisable under these plans as of December 31, 2022 was approximately 3 years and 7 months. The exercise
prices of the options outstanding as of December 31, 2022 ranged from $ 4.00 to $ 10.04 per share. The 210,500 stock options granted during
the year ended December 31, 2022 had exercise prices between $ 6.52 and $ 9.39 per share. The 86,000 stock options granted during the year
ended December 31, 2021 had exercise prices between $ 6.10 and $ 10.04 per share. The aggregate intrinsic value of options exercised during
the years ended December 31, 2022 and 2021 approximated $ 10,525 and $ 64,977 , respectively. The weighted-average grant date fair values
of options granted during the years ended December 31, 2022 and 2021 were $ 4.03 and $ 4.51 per share, respectively. As of December 31,
2022, total unrecognized stock-based compensation related to non-vested stock options aggregated $793,171, which will be recognized over
a weighted average remaining period of approximately 2 years. The fair value of each stock option grant has been estimated on the date
of grant using the Black-Scholes option pricing model, for the purpose discussed in Note 2(n), with the following weighted-average assumptions:
During the Years Ended
December 31,
2022
2021
Risk-free
interest rate (1)
3.04 %
0.86 %
Dividend yield (2)
0 %
0 %
Expected volatility (2)
53 %
54 %
Expected life (3)
5.9 years
5.0 years
(1) The risk-free interest rate is based on U.S. Treasury yields
for a maturity approximating the expected option term.
(2) The dividend yield and expected volatility are derived from
averages of our historical data.
(3) The expected life is calculated utilizing the simplified method,
which uses the mid-point between the vesting period and the contractual term as the expected life.
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 $ 70.00 per share, subject to adjustment. The description and terms
of the Rights are set forth in a Rights Agreement between the Company and American Stock Transfer & Trust Co., as Rights Agent.
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, the holder of each Right
not owned by the Acquiring Person would be entitled to purchase common stock at a discount to the initial purchase price of $70.00 per
share, effectively equal to one half of the market price of a share of common stock on the date the Acquiring Person becomes an Acquiring
Person. If, after the Distribution Date, the Company should consolidate or merge with any other entity and the Company were not the surviving
company, or, if the Company were the surviving company, all or part of the Company’s common stock were changed or exchanged into
the securities of any other entity, or if more than 50% of the Company’s assets or earning power were sold, each Right would entitle
its holder to purchase, at the Rights’ then-current purchase price, a number of shares of the acquiring company’s common stock
having a market value at that time equal to twice the Right’s exercise price.
F- 19
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
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.
During the third quarter of 2011, our Board of
Directors voted to authorize an amendment to the Rights Plan to increase the ownership threshold for determining “Acquiring Person”
status to 20 %. During the second quarter of 2015, our Board of Directors also voted to authorize an amendment to remove a provision that
prevented a new group of directors elected following the emergence of an Acquiring Person (an owner of more than 20 % of our stock) from
controlling the Rights Plan by maintaining exclusive authority over the Rights Plan with pre-existing directors. We did this because such
provisions have come to be viewed with disfavor by Delaware courts. Each time that we made such amendments we entered into amendments
to the Rights Agreement with the Rights Agent reflecting such extensions, threshold increases or provision changes. No other changes have
been made to the terms of the Rights or the Rights Plan.
At various times over the years, our Board of
Directors has voted to authorize amendments to the Rights Plan to extend the Final Expiration Date. Our Board of Directors decided to
seek an advisory vote by stockholders at the Annual Meeting of Stockholders held in June 2022, as to whether to extend the Rights Plan
by one year to September 19, 2023. Recognizing that there might be a substantial number of broker non-votes, our Board of Directors, which
has the authority to amend the Rights Plan, disclosed that it would be guided by the votes actually cast on this proposal in deciding
whether to extend the expiration date of such plan by one year. Of the votes actually cast on this proposal, 65% voted in favor, 32% voted
against and 3% abstained. On the basis of this vote, our Board of Directors voted to extend the Rights Plan by one year to September 19,
2023.
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 8,000,000 to 11,000,000 . At the June 10, 2020 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 11,000,000 to 15,000,000 .
14. REVENUE
We
primarily offer the First Defense Ò 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 years ended December 31, 2022 or 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.
F- 20
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
The following table presents our product sales
disaggregated by geographic area:
During the Years Ended December 31,
2022
%
2021
%
United States
$ 17,020,797
92 %
$ 16,620,363
86 %
Other
1,547,165
8 %
2,622,606
14 %
Total Product Sales
$ 18,567,962
100 %
$ 19,242,969
100 %
The following table presents our product sales
disaggregated by major product category:
During the Years Ended December 31,
2022
%
2021
%
First
Defense ® product line
$ 18,411,949
99 %
$ 18,933,092
98 %
Other animal health
156,013
1 %
309,877
2 %
Total Product Sales
$ 18,567,962
100 %
$ 19,242,969
100 %
15. OTHER EXPENSES, NET
Other expenses, net, consisted of the following:
During the Years Ended
December 31,
2022
2021
Interest expense (1)
$ 348,536
$ 314,359
(Gain) loss on disposal of property, plant and equipment
( 7,334 )
30,963
Interest income
( 153,100 )
( 18,810 )
Income - other
( 912 )
—
Other expenses, net
$ 187,190
$ 326,512
(1) Interest expense includes amortization of debt issuance costs
of $ 7,658 and $ 7,841 during the years ended December 31, 2022 and 2021, respectively.
16. INCOME TAXES
Our income tax expense aggregated $ 7,672 and $ 9,165
(amounting to less than 1 % and 13 % of our loss before income taxes) during the years ended December 31, 2022 and 2021, respectively. As
of December 31, 2022, we had federal net operating loss carryforwards of $15,516,167 of which $13,804,260 do not expire and of which $1,711,907
expire in 2034 through 2037 (if not utilized before then) and state net operating loss carryforwards of $1,106,340 that expire in 2037
through 2038 (if not utilized before then). Additionally, we had federal general business tax credit carryforwards of $673,233 that expire
in 2027 through 2042 (if not utilized before then) and state tax credit carryforwards of $791,397 that expire in 2023 through 2042 (if
not utilized before then).
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 $ 563,252 in non-cash income
tax expense to create a full valuation allowance against our net deferred tax assets (which consist largely of net operating loss carryforwards
and federal and state credits) based on applicable accounting standards and practices. At that time, we had incurred a net loss for six
consecutive quarters, had not been profitable on a year-to-date basis since the nine-month period ended September 30, 2017 and projected
additional net losses for some period going forward before returning to profitability. Should future profitability be realized at an adequate
level, we would be able to release this valuation allowance (resulting in a non-cash income tax benefit) and realize these deferred tax
assets before they expire. We will continue to assess the need for the valuation allowance at each quarter and, in the event that actual
results differ from these estimates, or we adjust these estimates in future periods, we may need to adjust our valuation allowance. Adjustments
related to the termination of our interest rate swap agreements were recorded during the first quarter of 2020. No subsequent adjustments
were recorded.
F- 21
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
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 audited
financial statements.
The income tax provision consisted of the following:
During the Years Ended December 31,
2022
2021
Current
Federal
$ —
$ —
State
7,672
9,165
Current subtotal
7,672
9,165
Deferred
Federal
( 576,780 )
( 63,097 )
State
( 88,533 )
( 14,990 )
Deferred subtotal, gross
( 665,313 )
( 78,087 )
Valuation allowance
665,313
78,087
Deferred subtotal, net
—
—
Income tax expense
$ 7,672
$ 9,165
The actual income tax expense differs from the expected tax computed
by applying the U.S. federal corporate tax rate of 21 % to the loss before income taxes during the years ended December 31, 2022 and 2021
respectively, as follows:
During the Years Ended December 31,
2022
2021
$
%
$
%
Computed expected income tax expense rate
$ ( 522,088 )
( 21.00 )%
$ ( 14,517 )
( 21.00 )%
State income taxes, net of federal expense
( 47,643 )
( 1.92 )
7,522
10.88
Share-based compensation
36,652
1.48
13,716
19.84
Tax credits
( 131,361 )
( 5.28 )
( 79,901 )
( 115.58 )
Valuation allowance
665,313
26.76
78,087
112.96
Other
6,799
0.27
4,258
6.16
Income tax expense/rate
$ 7,672
0.31 %
$ 9,165
13.26 %
The significant components of our deferred tax assets,
net, consisted of the following:
As of December 31,
2022
2021
Property, plant and equipment
$ ( 2,530,472 )
$ ( 2,483,145 )
Federal general business tax credits
673,233
557,795
Federal net operating loss carryforwards
3,258,395
3,094,283
State tax credits and net operating loss carryforwards
817,617
809,618
§174 R & D expenditures
341,683
—
Deferred compensation
23,370
—
Prepaid expenses and other
15,587
( 6,289 )
UNICAP
32,787
14,178
Incentive compensation
76,554
57,001
Valuation allowance
( 2,708,754 )
( 2,043,441 )
Deferred tax assets, net
$ —
$ —
F- 22
ImmuCell Corporation
Notes to Audited 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 core technology underlying
the Scours segment is derived around polyclonal antibodies. The Mastitis segment includes our products, CMT and Re-Tain ® .
Re-Tain ® is projected to be the driver of this segment when approved for sale. The core technology underlying the
Mastitis segment is derived around a bacteriocin called Nisin. 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 Year Ended December 31, 2022
Scours
Mastitis
Other
Total
Product sales
$ 18,411,949
$ 154,558
$ 1,455
$ 18,567,962
Costs of goods sold
10,754,189
136,347
28,647
10,919,183
Gross margin
7,657,760
18,211
( 27,192 )
7,648,779
Product development expenses
66,346
4,317,921
109,605
4,493,872
Sales and marketing expenses
1,871,926
1,318,107
—
3,190,033
Administrative expenses
—
—
2,263,817
2,263,817
Operating expenses
1,938,272
5,636,028
2,373,422
9,947,722
NET OPERATING INCOME (LOSS)
$ 5,719,488
$ ( 5,617,817 )
$ ( 2,400,614 )
$ ( 2,298,943 )
During the Year Ended December 31, 2021
Scours
Mastitis
Other
Total
Product sales
$ 18,933,092
$ 143,280
$ 166,597
$ 19,242,969
Costs of goods sold
10,411,936
99,957
75,147
10,587,040
Gross margin
8,521,156
43,323
91,450
8,655,929
Product development expenses
25,374
3,887,781
255,363
4,168,518
Sales and marketing expenses
1,942,391
561,535
—
2,503,926
Administrative expenses
—
—
1,726,100
1,726,100
Operating expenses
1,967,765
4,449,316
1,981,463
8,398,544
NET OPERATING INCOME (LOSS)
$ 6,553,391
$ ( 4,405,993 )
$ ( 1,890,013 )
$ 257,385
Scours
Mastitis
Other
Total
Total Assets as of December 31, 2022
$ 20,539,523
$ 18,315,492
$ 6,005,634
$ 44,860,649
Total Assets as of December 31, 2021
$ 14,860,769
$ 19,122,265
$ 10,482,654
$ 44,465,688
Depreciation and amortization expense during the year ended
December 31, 2022
$ 1,169,011
$ 1,263,318
$ 62,912
$ 2,495,241
Depreciation and amortization expense during the year ended
December 31, 2021
$ 1,032,735
$ 1,374,171
$ 62,075
$ 2,468,981
Capital Expenditures during the year ended December 31, 2022
$ 3,513,336
$ 414,486
$ 47,452
$ 3,975,274
Capital Expenditures during the year ended December 31, 2021
$ 1,632,855
$ 975,794
$ —
$ 2,608,649
F- 23
ImmuCell Corporation
Notes to Audited Financial Statements (continued)
18. RELATED PARTY TRANSACTIONS
David S. Tomsche (Chair of our Board of Directors) is a controlling
owner of Leedstone Inc., a domestic distributor of ImmuCell products (the First Defense ® product line and CMT ),
and of J-t Enterprises of Melrose, Inc., an exporter. His affiliated companies purchased $ 587,677 and $ 651,424 of products from us during
the years ended December 31, 2022 and 2021, respectively, all on terms consistent with those offered to other distributors of similar
status. Our accounts receivable (subject to standard and customary payment terms) due from these affiliated companies aggregated $ 46,426
and $ 55,490 as of December 31, 2022 and 2021, respectively.
19. EMPLOYEE BENEFITS
We have a 401(k) savings plan (the Plan) in which
all employees completing one month of service with the Company are eligible to participate. Participants may contribute up to the maximum
amount allowed by the Internal Revenue Service. We currently match 100% of the first 3% of each employee’s salary that is contributed
to the Plan and 50% of the next 2% of each employee’s salary that is contributed to the Plan. Under this matching plan, we paid
$ 159,058 and $ 139,401 into the Plan for the years ended December 31, 2022 and 2021, respectively.
20. SUBSEQUENT EVENTS
We have evaluated subsequent events through the
time of filing on the date we have issued this Annual Report on Form 10-K. Except for the contamination event and the bank debt covenant
waiver discussed below, there were no material, reportable subsequent events. Subsequent to year end, our standard in-process quality
control testing detected a contamination event in our production process. In response, we have temporarily slowed down production during
the first quarter of 2023 to investigate the root cause and remediate the problem. We anticipate this slowdown will reduce sales during
the first quarter of 2023 to between approximately $3,200,000 and $3,400,000. Due to the resulting loss in gross margin caused by the
reduced sales level, we have decided to defer, for the time being, certain capital expenditures. The related one-time charge to costs
of goods sold during the first quarter of 2023 is expected to be up to approximately $200,000, of which approximately $114,000 worth of
product remains under evaluation. During the first quarter of 2023, the Debt Service Coverage (DSC) ratio covenant for the year ending
December 31, 2023 was waived by our bank. Instead, we are required to meet a minimum DSC ratio requirement of 1.35 for the twelve-month
periods ending June 30, 2024, September 30, 2024 and December 31, 2024 and then again annually after that.
F- 24
ImmuCell Corporation
Signatures
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: March 29, 2023
By:
/s/ Michael F. Brigham
Michael F. Brigham President, Chief Executive Officer and Principal Financial Officer
POWER OF ATTORNEY
We, the undersigned directors of ImmuCell Corporation,
hereby severally constitute and appoint Michael F. Brigham our true and lawful attorney-in-fact and agent with full power of substitution
and re-substitution, for us and in our stead, in any and all capacities, to sign any and all amendments to this report and all documents
relating thereto, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and
Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing
necessary or advisable to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby
ratifying and confirming all that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or to be done by
virtue hereof.
Pursuant to the requirements of the Securities Exchange
Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates
indicated.
Signature
Title
Date
/s/ Gloria J. Basse
Director
March 22, 2023
Gloria J. Basse
/s/ Michael F. Brigham
President, Chief Executive Officer
March 22, 2023
Michael F. Brigham
Principal Financial Officer and Director
/s/ Bobbi Jo Brockmann
Vice President of Sales and Marketing and Director
March 22, 2023
Bobbi Jo Brockmann
/s/ David S. Cunningham
Director
March 22, 2023
David S. Cunningham
/s/ Steven T. Rosgen
Director
March 22, 2023
Steven T. Rosgen
/s/ David S. Tomsche
Director
March 22, 2023
David S. Tomsche, DVM
/s/ Elizabeth S. Toothaker
Controller
March 22, 2023
Elizabeth S. Toothaker
/s/ Paul R. Wainman
Director
March 22, 2023
Paul R. Wainman
38