ITEM 7 — MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our
financial condition and results of operations should be read together with our audited financial statements and the related notes and
other financial information included in Part II, Item 8, “Financial
Statements and Supplementary Data” of this Annual Report on Form 10-K. Some of the information contained in this discussion and
analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business,
includes forward-looking statements that involve risks and uncertainties. One should review Part I, Item 1A — “Risk
Factors” of this Annual Report for a discussion of some of the important factors that could cause actual results to differ materially
from the results, objectives or expectations described in or implied by the forward-looking statements contained in the following discussion
and analysis.
22
ImmuCell Corporation
Liquidity and Capital Resources
Net
cash provided by operating activities was $954,000 during the year ended December 31, 2021 in comparison to net cash provided by operating
activities of $1.3 million during the year ended December 31, 2020. The $361,000 decrease in cash provided by operating activities from
period to period was largely the result of a $944,000 decrease in our net loss, no debt forgiveness in 2021, a $1.4 million increase (changing
from a source of cash to a use of cash) in cash used for inventory and a $738,000 increase in cash used for accounts receivable. As we
increase our production capacity to fill the backlog of orders, our inventory balance increased by $997,000 from December 31, 2020 to
December 31, 2021. Approximately 46% of this increase was work-in-process inventory. Our total depreciation expense was approximately
$2.4 million and $2.3 million during the years ended December 31, 2021 and 2020, respectively. We anticipate that depreciation expense,
while not affecting our cash flows from operations, will result in net operating losses until and unless product sales increase sufficiently
to offset these non-cash expenses. Cash used for investing activities was $1.6 million and $2.6 million during the years ended December
31, 2021 and 2020, respectively. Cash paid for capital expenditures was $2.6 million and $4.1 million during the years ended December
31, 2021 and 2020, respectively, which payments were largely related to our ongoing investments to expand our manufacturing facilities.
Cash provided by financing activities increased to $3.9 million during the year ended December 31, 2021 in comparison to $1.9 million
during the year ended December 31, 2020. The $4.2 million equity raise we completed during the second quarter of 2021 was the largest
cause of this change. Going forward, repayments of the indebtedness incurred to fund these capital expenditures and acquire these assets
will reduce our cash flows. Debt principal payments (exclusive of the $8.3 million used to repay our refinanced bank debt during the first
quarter of 2020 and the $624,000 used to pay down our mortgage debt during the fourth quarter of 2020) were $768,000 and $633,000 during
the years ended December 31, 2021 and 2020, respectively. Reflecting the mortgage debt financing we completed during the first quarter
of 2022, we are obligated to make debt principal repayments of approximately $875,000 and $925,000 under these loans during the years
ending December 31, 2022 and 2023, respectively, and we anticipate that our interest expense will be approximately $325,000 and
$317,000 during the years ending December 31, 2022 and 2023, respectively.
We have funded most of our business operations
principally from the gross margin on our product sales and equity and debt financings. Based on our best estimates and projections, we
believe that our cash and cash equivalents, together with gross margin anticipated to be earned from ongoing product sales, will be sufficient
to meet our currently planned working capital and capital expenditure requirements and to finance our ongoing business operations for
at least 12 months (which is the period of time required to be addressed for such purposes by accounting disclosure standards) from the
date of this filing. The table below summarizes the changes in selected, key accounts (in thousands, except for percentages):
As of As of Increase
Cash, cash equivalents and short-term investments $ 10,185 $ 7,946 $ 2,239 28 %
During the first quarter of 2020, we closed on
a debt refinancing aggregating $8.6 million plus a line of credit in the amount of $1.0 million with Gorham Savings Bank (GSB). This
new debt was comprised of a $5.1 million mortgage note that bears interest at a fixed rate of 3.50% per annum (with a 10-year term and
25-year amortization schedule, resulting in a balloon principal payment of $3.1 million due during the first quarter of 2030) and a $3.5
million note that bears interest at a fixed rate of 3.50% per annum (with a 7-year term and amortization schedule). The refinancing proceeds
were used to provide some additional working capital, but mostly to refinance $8.3 million of then outstanding bank debt and pay off
an interest rate swap termination liability of $165,000. This debt refinancing improved our liquidity by lowering our interest expense,
spreading our principal payments out over a longer time period and eliminating pending balloon principal payments that existed under
some of the repaid debt. Under this GSB debt, we were required to hold $1.4 million in escrow (a non-current asset), which reduced the
effective availability of our liquid assets for operational needs by that amount. During the fourth quarter of 2020, we closed on a $1.5
million note with GSB that bears interest at a fixed rate of 3.50% per annum (with a 7-year term and amortization schedule). We used
$624,000 of the proceeds to prepay a portion of the then outstanding principal on our mortgage note, which reduced the then outstanding
balance to 80% of the most recent appraised value of the property securing the debt, which allowed GSB to release the $1.4 million of
funds held in escrow. During the first quarter of 2022, we closed on a mortgage debt financing that added $2 million in new funds to
the $4.2 million of mortgage debt outstanding at the time of closing. The amended mortgage principal of $6.2 million bears interest at
the weighted-average blended fixed rate of 3.53% per annum (with a 10-year term and 20-year amortization schedule, resulting in a balloon
principal payment of $3.68 million due during the first quarter of 2032). Also during the first quarter of 2022, the availability of
our $1.0 million line of credit, which bears interest at the National Prime Rate plus 0.00% per annum, was extended until March 11, 2024.
We may use some of these proceeds to repay two loans from the Maine Technology Institute (MTI) aggregating $900,000 (described below)
when they become interest bearing at the fixed rate of 5% per annum during the fourth quarter of 2022 and the third quarter of 2023.
These GSB credit facilities are secured by substantially all of our assets, including our facility at 56 Evergreen Drive in Portland
(which was independently appraised at $6.3 million in connection with the 2022 financing, at $3 million in connection with the 2020 refinancing
and at $4.2 million in connection with the 2015 financing) and our facility at 33 Caddie Lane in Portland (which was independently appraised
at $3.2 million in connection with a 2017 financing and at $2.5 million in connection with the 2020 refinancing). These credit facilities
are subject to certain restrictions and financial covenants. We are required to meet a minimum debt service coverage ratio set by GSB
of 1.35. Our actual debt service coverage (DSC) ratio was equal to 2.68, 2.03 and 1.57 during the years ended December 31, 2021, 2020
and 2019, respectively. However, based on current projections of our future financial performance, which includes a high level of ongoing
product development expenses to support Re-Tain®, we may not satisfy this annual requirement for the year ending
December 31, 2022. By negotiation with the bank in connection with a mortgage debt financing during the first quarter of 2022, the required
minimum DSC ratio was reduced to 1.0 for the year ending December 31, 2022.
23
ImmuCell Corporation
During June 2020, we received a $500,000 loan
from the MTI. The first 2.25 years of this loan are interest-free with no interest accrual or required principal payments. Principal and
interest payments at a fixed rate of 5% per annum are due quarterly over the final 5 years of the loan, beginning during the fourth quarter
of 2022 and continuing through the third quarter of 2027. During July 2021, we received an additional $400,000 loan from the MTI. The
first 2 years of this second loan are interest-free with no interest accrual or required principal payments. Principal and interest payments
at a fixed rate of 5% per annum are due quarterly over the final 5.5 years of the loan, beginning during the third quarter of 2023 and
continuing through the fourth quarter of 2028. Both loans are unsecured and subordinated to all other bank debt and may be prepaid without
penalty at any time. This support from the State of Maine through the MTI helps us move forward aggressively with our investments while
increasing our total employee count.
From the first quarter of 2016 through the second
quarter of 2021, we raised gross proceeds of approximately $26.7 million (net proceeds were approximately $24.8 million) from six different
common equity transactions priced between $5.25 and $8.25 per share. No warrants were issued in connection with any of these transactions,
and no convertible or preferred securities were issued. The net proceeds have been and are being used to fund the expenditures described
under PROJECT B to PROJECT G in the tables and footnotes below as well as to provide additional working capital. Additionally,
we are using a portion of this new equity funding to pay for our routine and miscellaneous capital expenditures. Our approved capital
expenditure budget for the year ending December 31, 2022 is $550,000. These expenditures amounted to $260,000, $554,000 and $574,000 during
the years ended December 31, 2021, 2020 and 2019, respectively.
From 2014 to 2019, we initiated four capital expenditure
investments, as described in the following table (in thousands):
Cash Paid on Projects Initiated before 2021 During the
A B C D Total
PROJECT A included a 7,100 square foot
facility addition at 56 Evergreen Drive and related equipment and cold storage capacity to increase the production capacity for the First
Defense® product line. During the first quarter of 2016, we completed this investment, increasing our freeze drying
capacity by 100% and making other improvements to our liquid processing capacity, which increased our annual production capacity (in terms
of annual sales dollars) to approximately $16.5 million. The actual value of our production output varies based on production yields,
selling price, product format mix and other factors. This investment also included the construction and equipping of a pilot plant for
small-scale Drug Substance production for Re-Tain® within our First Defense® production facility
at 56 Evergreen Drive. After PROJECT B was completed, this space was converted for use in the production of the gel tube formats
of the First Defense® product line. One of the objectives of PROJECT C was a relocation of these gel tube
operations to 175 Industrial Way, vacating production space at 56 Evergreen Drive for use in doubling our liquid processing capacity.
24
ImmuCell Corporation
PROJECT B was related to the Drug Substance
production facility for Re-Tain® at 33 Caddie Lane. During the fourth quarter of 2017, we completed construction
of the Drug Substance production facility. We began equipment installation during the third quarter of 2017, and we completed this installation
during the third quarter of 2018. The total cost of this investment for the Drug Substance production facility and related processing
equipment was $20.8 million plus $331,000 for the land and $472,000 for the acquisition of an adjacent 4,080 square foot warehouse facility,
which will be used for cold storage of Re-Tain® inventory and other warehousing needs.
PROJECT C (Phase I of our investments
to increase our production capacity for the First Defense® product line) consists of significant renovations to
a 14,300 square foot leased facility at 175 Industrial Way, some facility modifications at 56 Evergreen Drive and the necessary production
equipment to increase the annual production capacity of the First Defense® product line (in terms of annual sales
dollars) from approximately $16.5 million to approximately $23 million. The actual value of our production output varies based on production
yields, selling price, product format mix and other factors. This project was completed at the end of 2021 at approximately 4%, or $153,000,
over its budget of $3.5 million. This expansion involves a 40% increase in our freeze drying capacity and a 100% increase in our liquid
processing capacity. Renovations to our leased facility at 175 Industrial Way to enable this expansion were completed during the second
quarter of 2020. By moving our powder filling and assembly services from 56 Evergreen Drive into this new space at 175 Industrial Way,
we created space at 56 Evergreen Drive for the installation of the expanded freeze drying capacity. The new facilities are built to contemporary
cGMP standards with good material and people flows. A site license approval for this new facility at 175 Industrial Way was issued by
the USDA during the third quarter of 2020. During the second quarter of 2021, we completed the relocation of our gel formulation equipment
from 56 Evergreen Drive to 175 Industrial Way, creating space for the doubling of our liquid processing capacity at 56 Evergreen Drive.
As part of this investment, we also have made the facility modifications at 56 Evergreen Drive necessary for a future expansion of our
freeze drying capacity by an additional 35%, which would increase our annual production capacity from approximately $23 million to approximately
$30 million or more (see PROJECT F below). We obtained site license approval of the expanded freeze drying capacity at 56 Evergreen
Drive from the USDA during the third quarter of 2021, and we obtained temporary (subject to final USDA review and approval) site license
approval of the expanded liquid processing capacity at 56 Evergreen Drive from the USDA during the first quarter of 2022.
PROJECT D is a $4 million budgeted investment
to bring the formulation and aseptic filling capabilities for Re-Tain® Drug Product in-house to end our reliance
on third-party Drug Product manufacturing services. We began equipment installation during the first quarter of 2022, and we expect to
have our facility qualified by the end of 2022. We anticipate FDA approval of this facility (which is a requirement for commercial manufacturing)
during the fourth quarter of 2023 or the second quarter of 2024.
With the additional equity funding of approximately
$4.3 million that we raised during the second quarter of 2021, we initiated three more capital expenditure investments, as described in
the following table (in thousands):
Cash Paid on Projects Initiated in 2021
E F G Total
PROJECT E represents an original budget
of $500,000 for equipment and vehicle investments necessary to expand and improve our colostrum collection capabilities and logistics.
During the second quarter of 2021, this budget was increased from $500,000 to $550,000.
25
ImmuCell Corporation
PROJECT F (Phase II of our investments
to increase our production capacity for the First Defense® product line) represents a budget estimate of $925,000
for freeze drying equipment to expand on PROJECT C to further increase the annual production capacity of the First Defense®
product line (in terms of annual sales dollars) from approximately $23 million to approximately $30 million or more by increasing our
freeze drying capacity by an additional 33%. The actual value of our production output varies based on production yields, selling price,
product format mix and other factors. We initiated PROJECT F during the third quarter of 2021, and we anticipate completing this
investment during the third quarter of 2022.
PROJECT
G first represented an initial estimate of $1 million for equipment and facility modifications costs to scale-up and upgrade our vaccine
manufacturing capacity. During the third quarter of 2021, the scope of this project was changed to cover less money for vaccine equipment
and more money for pack & ship facilities for Re-Tain®, improvements to our quality offices and laboratories
and new equipment for our gel filling operations. We estimate the additional investments in our gel filling equipment will increase our
annual production capacity for the First Defense®
product line (in terms of annual sales dollars) further from approximately $30 million to approximately $35 million. The
actual value of our production output varies based on production yields, selling price, product format mix and other factors. As a result
of these scope changes, the preliminary project budget was increased to $2.52 million.
We have set aside approximately $5.5 million
of the $10.2 million of the cash we had on hand as of December 31, 2021 to complete PROJECT D to PROJECT G as well as to
pay for our other routine and miscellaneous capital expenditures during 2022, leaving the remaining cash balance of approximately $4.7
million available for general working capital purposes including anticipated inventory builds for both First Defense®
and Re-Tain®.
During the third quarter of 2016, the City of
Portland approved a Tax Increment Financing (TIF) credit enhancement package that reduces the real estate taxes on our Drug Substance
production facility for Re-Tain® by 65% over the
eleven-year period beginning on July 1, 2017 and ending June 30, 2028 and by 30% during the year ending June 30, 2029, at which time the
rebate expires. During the second quarter of 2017, the TIF was approved by the Maine Department of Economic and Community Development.
The value of the tax savings will increase (decrease) in proportion to any increases (decreases) in the assessment of the building for
city real estate tax purposes or the City’s tax rate. The following table discloses how much of the new taxes we have generated
is being relieved by the TIF and how much is being paid by ImmuCell:
Results of Operations
Business Segments
As detailed
in Note 17, “Segment Information”, to the accompanying audited financial statements, we operate in two business segments.
The First Defense®segment
is dedicated to manufacturing and selling First Defense®,
a product used to prevent scours in newborn calves, which is regulated by the USDA. The Re-Tain®
segment is focused on developing and commercializing Re-Tain®,
a product to treat subclinical mastitis in lactating dairy cows, which is regulated by the FDA.
Product Sales
Sales of the First Defense®
product line aggregated 98% of our total sales during both of the years ended December 31, 2021 and 2020, and we set records for high
sales during the second, third and fourth quarters of 2021 in comparison to the same quarters of the prior year. Sales of the First
Defense® product line increased from approximately $4,473,000 during the quarter ended June 30, 2021 to $5,033,000
during the quarter ended September 30, 2021 to $5,403,000 during the quarter ended December 31, 2021. Most of our growth (when
not limited by the backlog) is being realized through increased demand and a deliberate strategy to prioritize production capacity towards
Tri-Shield® (the trivalent format of our product delivered via a gel tube), which provides broader protection to
calves. The compound annual growth rate of our total product sales during the ten years ended December 31, 2021 was approximately 15%.
The compound annual growth rate of our total product sales during the three years ended December 31, 2021 was approximately 18%.
26
ImmuCell Corporation
During the Three-Month Periods Ended December 31, Increase
(In thousands, except for percentages) 2021 2020 Amount %
Sales increased by 45%, or $1.7 million, during
the three-month period ended December 31, 2021, in comparison to the three-month period ended December 31, 2020. Domestic sales increased
by 34%, and international sales increased by 136%, in comparison to the three-month period ended December 31, 2020. International sales
aggregated 18% and 11% of total sales during the three-month periods ended December 31, 2021 and 2020, respectively.
During the Years Ended December 31, Increase
(In thousands, except for percentages) 2021 2020 Amount %
Sales increased by 25%, or $3.9 million, during
the year ended December 31, 2021, in comparison to the year ended December 31, 2020. Domestic sales increased by 22%, and international
sales increased by 55%, in comparison to the year ended December 31, 2020. International sales aggregated 14% and 11% of total sales during
the years ende December 31, 2021 and 2020, respectively.
Starting
in the third quarter of 2016 and through most of 2017, we had sufficient available inventory and were shipping in accordance with the
demand of our distributors. However, we quickly sold out of our initial launch quantities of Tri-Shield First Defense®
(which added a valuable rotavirus claim to our legacy E. coli and coronavirus product) soon after regulatory approval was obtained
during the fourth quarter of 2017. Tri-Shield® has changed our capacity models significantly because it requires
almost twice as much production capacity to produce each finished dose and demand for this product format has increased each year. During
most of 2018 and into the first half of 2019, we could only accept purchase orders from customers for Tri-Shield®
to match available inventory, which required a careful allocation of product supply directly to certain end-users and veterinary clinics.
Initially, production of this new product format did not keep pace with demand primarily because of our inability to produce enough of
the new, complex rotavirus vaccine that is used to immunize our source cows. Work on production improvements in our vaccine laboratory
throughout 2018 led to significant improvements in vaccine yield and process repeatability. Allowing for the five to six month production
cycle from the manufacture of our proprietary vaccine to the production of a finished dose, we were able to return to a mass market selling
approach through distribution for Tri-Shield® during the second half of 2019, and we ended the year with no backlog
as of December 31, 2019. Sales of the First Defense® product line during the years ended December 31, 2021 and 2020
have continued to increase, creating a backlog of orders at the end of each quarter during this two-year period. Valuation of the
backlog is a non-GAAP estimate that is based on purchase orders on hand at the time that could not be met because of a lack of available
inventory. The backlog was worth approximately $2.4 million as of December 31, 2021 and approximately $2.8 million as of March 18, 2022.
However, quantification of the backlog during the current periods has become far less comparable to prior periods. We believe our customers
are now placing orders for more than a month’s worth of their demand, perhaps in reaction to our ongoing backlog situation, whereas
in the past they ordered more closely in line with their more current demand. Additionally,
we believe that our distributors are reacting to this global economic challenge by ordering in more product for their inventory, which
is a very different cash management strategy from the recent past, when they were much more likely to invest less money in their inventory
and order from us more often to meet just current demand (“just-in-time” cash management). The growth in our sales
(which are seasonal) and the expansion of our production capacity (which is generally delivered approximately evenly across the four quarters
of the year) are described in the following table:
Quarterly Annualized
Estimated production capacity before current expansion $ 4,125,000 $ 16,500,000
27
ImmuCell Corporation
We have largely completed the critical objectives
of our investment to increase our First Defense® production capacity from approximately $16.5 million to approximately
$23 million in terms of annual sales value. These capacity estimates are subject to biological yield variance, product format mix, selling
price and other factors. Equipment modifications and relocations of this nature require a shutdown of operations for weeks to months to
install and validate the modified equipment and achieve USDA approval for its use in its new location. The qualification and implementation
of the final two pieces of equipment required to complete this project were delayed past our June 30, 2021 target. We have worked around
this setback to meet our increased production requirements by utilizing our expanded manufacturing staff to extend shifts and temporarily
produce more product from the existing equipment. We obtained site license approval of our expanded freeze drying capacity from the USDA
during the third quarter of 2021, and we anticipate obtaining site license approval of our expanded liquid processing capacity from the
USDA during the first quarter of 2022. During the third quarter of 2021, we initiated an additional investment of approximately $925,000
to increase our annual production capacity for the First Defense® product line further from approximately $23 million
to approximately $30 million or more per year by the third quarter of 2022. Then, during the fourth quarter of 2021, we initiated an additional
investment to further increase our annual production capacity to approximately $35 million.
The significant global supply-chain disruptions
that almost all industries are experiencing presently are a challenge to us and contribute to our order backlog. Most prices for certain
essential raw materials and critical supplies are increasing significantly, and it is more and more difficult to obtain timely delivery
of the orders that we place. Therefore, we have little choice but to pay the higher prices and try to take on more months of supply than
we would have held previously if we could get our orders fulfilled.
While our backlog is a very positive indication
about the strong demand for our First Defense® product line, we missed some business during 2021 as a result of
the backlog. Not being able to timely meet the needs of our customers could result in the loss of some customers who seek alternative
scours management products during this period of short supply and who may not resume purchasing our product when we have eliminated the
backlog. While backlog is a better problem to have than seeing product expiring
on our shelves, it is nonetheless a significant challenge when we do not get our customers everything that they want. Our sales team is
resuming more normal sales growth initiatives with more available inventory on hand during the fourth quarter of 2021 and into peak season
during the first quarter of 2022. We are working to regain customers that we may have lost while we were short on product. As we emerge
from an extended period of time on backlog, we anticipate higher than normal sales fluctuations quarter to quarter. As we emerge from
the backlog, what is most important to us is that we achieve sales growth over the longer periods of time, even if we experience some
quarter-to-quarter fluctuations.
Effective January 1, 2022, we increased our selling
price of the First Defense® product line by approximately
5%. Effective January 1, 2021, we increased our selling price of the First Defense®
product line in the domestic market by approximately 1.6% to 3%, depending on product format, and we increased our selling
price of CMT by almost 4%. Effective February 1, 2020, we implemented a price increase of approximately 2% on the First Defense®
product line (except for Tri-Shield® and the 90-dose bulk powder format) and CMT. Effective January 1, 2019,
we implemented a 2% price increase for Dual-Force®.
Sales of products other than the First Defense®
product line increased by 15%, or $40,000, to $310,000 during the year ended December 31, 2021 in comparison to the year ended December
31, 2020. Sales of these other products aggregated approximately 2% of our total product sales during both of the years ended December
31, 2021 and 2020. We acquired a private label product (our second leading source of product sales during 2021) in connection with our
January 2016 acquisition of certain gel formulation technology. We sell our own CMT (our third leading source of product sales
during 2021), which is used to detect somatic cell counts in milk.
28
ImmuCell Corporation
Impact of Global COVID-19 Pandemic
The extent of the negative impact of the COVID-19
pandemic on the economics of our customers and on the demand for our products going forward is very difficult to assess. The Class III
milk price has been extremely volatile during the pandemic. Initially, stay at home orders disrupted the food service supply system as
schools closed and restaurants were shut down. In response, producers were forced to reduce the supply of milk to the market by drying
off cows early, culling cows from the herd and dumping milk, among other tactics. Market conditions are better now, but this volatility
remains a concern. Additionally, like most input costs, the cost of feed is rising, which puts a strain on the profitability of our customers.
The $938,000 in funding that we received from the federal government through the Paycheck Protection Program (PPP) under the CARES Act
(which loan was forgiven by the federal government during 2020) helped us maintain full employment without furloughs or layoffs and continue
executing our growth plans. The PPP funding created some needed financial liquidity, allowing us to move forward with our investments
even though we did not achieve the level of sales anticipated in our 2020 budget.
Gross Margin
Changes in our gross margin (product sales less
costs of goods sold) are summarized in the following table for the respective periods (in thousands, except for percentages):
During the Three-Month Periods Ended December 31, Increase
Percent of product sales 47 % 43 % 4 % 9 %
During the Years Ended December 31, Increase
Percent of product sales 45 % 45 % — 1 %
The gross margin as a percentage of product sales
was 45%, 45%, 49%, 47% and 50% during the years ended December 31, 2021, 2020, 2019, 2018 and 2017, respectively. During the first quarter
of 2021, the gross margin of 39% was lower than what we normally expect. This gross margin improved to 46% during the second quarter of
2021 and further to 47% during both the third and fourth quarters of 2021, as we began to spread these fixed costs over increasing production
output. As we fully integrate and utilize our increased capacity, we expect to be able to achieve an annual gross margin in excess of
46%. The costs of most of our supplies, components, raw materials and services increased significantly during 2021. The Tri-Shield®
product format is more complex (i.e., three antibodies versus two antibodies for Dual-Force®)
making it more costly to produce, and both the bivalent and trivalent gel product formats are more expensive to produce than the bolus
format. These new formats are creating sales growth for us, and we are focused on increasing total gross margin dollars (after we fulfill
the backlog) even if that is accomplished with a lower gross margin as a percentage of sales. We are investing significantly in equipment,
infrastructure and operating expenses to increase our annual production capacity from approximately $16.5 million to approximately $35
million. Increased labor and other upfront costs were necessary to benefit from the scale-up of our production output going forward. A
number of other factors contribute to the variability in our costs, resulting in some fluctuations in gross margin percentages from quarter
to quarter and from year to year. Like most U.S. manufacturers, we have also been experiencing increases in the cost of labor and raw
materials. We also invest to sustain compliance with current Good Manufacturing Practices (cGMP) in our production processes. Increasing
production can be more expensive in the initial stages. To achieve our inventory production growth objectives, we are acquiring more raw
material (colostrum) from many more cows at many new farms. As is the case with any vaccine program, animals respond less effectively
to their first exposure to a new vaccine, and thereafter the effectiveness of their immune response improves in response to subsequent
immunizations. During this expansion phase, colostrum quality can be more variable. Additionally, the biological yields from our raw material
are always variable, which impacts our costs of goods sold in a similar way. Just as our customers’ cows respond differently to
commercial dam-level vaccines, depending on time of year and immune competency, our source cows have similar biological variances in response
to our proprietary vaccines. The value of our First Defense® product line is that we compensate for the variability
in a cow’s immune response by standardizing each dose of finished product. This ensures that every calf is equally protected, which
is something that dam-level commercial scours vaccines cannot offer. We continue to work on processing and yield improvements and other
opportunities to reduce costs, while enhancing process knowledge and robustness. Over time, we have been able to reduce the impact of
cost increases by implementing yield improvements. As we evaluate our product costs and selling price, one of our goals is to achieve
a gross margin (before related depreciation and amortization expenses) as a percentage of total sales approaching 50%.
29
ImmuCell Corporation
Product Development Expenses
Overview: During
the year ended December 31, 2021, product development expenses decreased by 4%, or $186,000, to $4.2 million in comparison to $4.4 million
during the year ended December 31, 2020. Product development expenses aggregated 22% and 28% of product sales during the years ended December
31, 2021 and 2020, respectively. Product development expenses included approximately $1,495,000 and $1,608,000 of non-cash depreciation
and stock-based compensation expenses during the years ended December 31, 2021 and 2020, respectively. We do expect our product development
expenses to decrease further after Re-Tain® is commercialized and most of the costs incurred to maintain and run
our Drug Substance production facility become part of our costs of goods sold.
Development objective: We
aim to demonstrate that our peptide antimicrobial, Nisin A, can play a productive role in the treatment of subclinical mastitis in today’s
dairy industry by providing a novel alternative to traditional antibiotics. Because label requirements of all intramammary drugs on the
market require that milk be discarded and that meat be withheld during treatment and for a period of time thereafter, it is common practice
in the dairy industry today to not treat sick cows that are still producing saleable milk. Re-Tain® provides an
animal welfare benefit by removing this economic disincentive to treating subclinical mastitis and allows sick cows to be treated without
the milk discard and meat withhold penalties. In addition to improved animal welfare, Re-Tain® enhances food safety
and sustainability by utilizing a peptide antimicrobial that is not used in human medicine. The overuse of traditional antibiotics is
thought to create antibiotic resistance, which is a growing public health concern. By treating mastitis early at the subclinical level,
producers could preserve peak milk yields and reduce the number of infections that develop into clinical cases requiring antibiotic treatment
and milk discard. Re-Tain® could increase the lifetime profitability of a cow and reduce disease transfer to herd
mates. As with all new products, the market determines the value. Our objective is to gain market acceptance of this new product concept
as we develop a new product category. Despite those exciting benefits, it will take time to change this longstanding treatment paradigm
and develop this new market. It will take time for the market to understand, evaluate, implement and adapt to the benefits of Re-Tain®.
As we prepare for market launch after we receive the anticipated and required FDA approval of this product, we are carefully considering
our best go-to-market strategy in consultation with industry-leading consultants, veterinarians, dairy producers and others. We believe
that the primary market for Re-Tain® (at least initially) may be limited to the approximately half of farms that
have somatic cell count data at the cow or quarter level, since that is the most common and efficient way to identify subclinical infections
and to assess the effectiveness of treatment. We are making plans for a controlled launch where our sales team can work directly with
first adopters to help ensure that the best candidate cows are selected and that the product is properly administered in accordance with
its label. We believe that developing a solid foundation of in-the-field successes early on will give our product the best opportunity
for success.
30
ImmuCell Corporation
Development status of Re-Tain®:
The majority of our product development spending has been focused on the development of Re-Tain®, our purified Nisin
treatment for subclinical mastitis in lactating dairy cows. Approval by the Center for Veterinary Medicine, U.S. Food and Drug Administration
(FDA) of the New Animal Drug Application (NADA) for Re-Tain® is required before any sales of the product can be
initiated. The NADA is comprised of five principal Technical Sections that are generally subject to one or more six-month review cycle(s)
by the FDA and a sixty-day administrative review at the end. By statute, each Technical Section submission is generally subject to a six-month
review cycle by the FDA. Each Technical Section can be reviewed and approved separately. Upon review and assessment by the FDA that all
requirements for a Technical Section have been met, the FDA may issue a Technical Section Complete Letter. The current status of our work
on these submissions to the FDA is as follows:
1) Environmental Impact: During
the third quarter of 2008, we received the Environmental Impact Technical Section Complete Letter from the FDA. During the second quarter
of 2021, we received further clarification through a new Environmental Impact Technical Section Complete Letter covering the current dosage
regimen and labeling.
2) Target Animal Safety: During
the second quarter of 2012, we received the Target Animal Safety Technical Section Complete Letter from the FDA.
3) Effectiveness: During the
third quarter of 2012, we received the Effectiveness Technical Section Complete Letter from the FDA. The anticipated product label (which
remains subject to FDA approval) carries claims for the treatment of subclinical mastitis associated with Streptococcus agalactiae,
Streptococcus dysgalactiae, Streptococcus uberis, and
coagulase-negative staphylococci in lactating dairy cattle.
4) Human Food Safety: During
the third quarter of 2018, we received the Human Food Safety Technical Section Complete Letter from the FDA confirming, among other things,
a zero milk discard period and a zero meat withhold period during and after treatment with our product. During the second quarter of 2021,
we updated this Technical Section Complete Letter with FDA approval of the official analytical method to measure Nisin in milk.
5) Chemistry, Manufacturing
and Controls (CMC): The CMC Technical Section is very complex and comprehensive. Having previously achieved the four different Technical
Section Complete Letters from the FDA discussed above, approval of the CMC Technical Section is the fifth and final significant step required
before Re-Tain®product sales can be initiated in the United States.
Implementing Nisin Drug Substance (the active pharmaceutical ingredient) production, which is a required component of the CMC Technical
Section, has been the most expensive and lengthy part of this project. We previously entered into an agreement with a multi-national pharmaceutical
ingredient manufacturer for our commercial-scale supplies of Nisin. However, we determined during 2014 that the agreement did not offer
us the most advantageous supply arrangement in terms of either cost or long-term dependability. We presented this product development
opportunity to a variety of large and small animal health companies. While such a corporate partnership could have provided access to
a much larger sales and marketing team and allowed us to avoid the large investment in a commercial-scale production facility, we concluded
that a partner would have taken an unduly large share of the gross margin from all future product sales of Re-Tain®,
but the regulatory and marketing feedback that we received from prospective partners, following their due diligence, was positive. During
the third quarter of 2014, we completed an investment in facility modifications and processing equipment necessary to produce the Nisin
Drug Substance at small-scale at our 56 Evergreen Drive facility. This small-scale facility was used to: i) expand our process knowledge
and controls, ii) establish operating ranges for critical process parameters, iii) conduct product stability studies, iv) optimize process
yields and v) verify the cost of production. We believe these efforts have reduced the risks associated with our investment in the commercial-scale
Drug Substance production facility, discussed below. Having raised equity during 2016 and 2017, we were able to move away from these earlier
strategies and assume control over the commercial-scale manufacturing process in our own facility. During the fourth quarter of 2015,
we acquired land near our existing Portland facility for the construction of a new commercial-scale Drug Substance production facility.
We commenced construction of this facility during the third quarter of 2016 and completed construction during the fourth quarter of 2017.
Equipment installation and qualification was initiated during the third quarter of 2017 and completed during the third quarter of 2018.
Total construction and equipment costs aggregated approximately $20.8 million.
Under
the FDA’s phased submission process, we made a first-phased submission covering just the Nisin Drug Substance (DS) during the first
quarter of 2019, which was followed by a second-phased submission covering both the DS and the formulated DS filled in a syringe, or Re-Tain®Drug Product (DP) during the first quarter of 2021. This process allowed us to respond to identified
queries and/or deficiencies from the first-phased DS submission at the time of the second-phased combined DS and DP submission. The first-phased
DS submission included data from the DS Registration Batches produced at commercial scale in our new DS manufacturing facility. The second-phased
DS and DP submission responded to comments raised by the FDA regarding the first-phased DS submission and included detailed information
about the manufacturing process and controls for DP. One of the key components of the second-phased DS and DP submission was also demonstrating
stability of the product through expiration dating. During the third quarter of 2021, the FDA issued a Technical Section Incomplete Letter
with regard to this second-phased DS and DP submission. This response was not unexpected as it is common for the FDA to issue queries
and comments, especially related to an aseptic DP submission with associated sterilization validation information. We made a second submission
of the DS and DP Technical Section during the first quarter of 2022. Allowing time for the six-month review by the FDA and for the final
sixty-day administrative review at the end of the process, we could achieve market launch during the third quarter of 2022 if the FDA
approves our second DS and DP submission. It is up to the FDA to determine if it will issue a Technical Section Complete or Incomplete
Letter. Because we cannot predict the FDA’s responses, we cannot project the probability of success with this DS and DP submission.
We intend to be completely transparent about the FDA’s response (positive or negative) around August 2022. While being prudent with
how much cash we invest into inventory that would have short expiry dating if market launch is not achieved by the third quarter of 2022,
we plan to continue to build more inventory during 2022 to bridge the transition between DP supply from Norbrook, our contract manufacturer,
to our own in-house services, as discussed further below.
31
ImmuCell Corporation
We have
always believed that the fastest route to FDA approval and market launch is with the services of Norbrook Laboratories Limited of Newry,
Northern Ireland (an FDA-approved DP manufacturer) (Norbrook), reducing our risk by benefiting from their demonstrated expertise in aseptic
filling. From 2010 to 2015, we were a party to an exclusive product development and contract manufacturing agreement with Norbrook covering
the DP formulation, aseptic filling and final packaging services. Norbrook provided services to us under this contract throughout
the FDA process for use in all of our pivotal studies. During the fourth quarter of 2015, this agreement was amended and restated
to create a Product Development and Contract Manufacture Agreement (the 2015 Agreement) to, among other things, extend the term of the
agreement to January 1, 2024 provided that FDA approval for commercial sales of Re-Tain® in the United States was
obtained by December 19, 2019. It had been our expectation that we would have these services available through both the remainder
of the development process to FDA approval and for approximately the first four years of commercial sales of Re-Tain®. Due
to unexpected difficulties and delays encountered by Norbrook and the statutory FDA timeline for processing CMC Technical Sections, this
December 2019 product approval target date was not achieved. During the third quarter of 2019, we entered into a Development Services
and Commercial Supply Agreement (the 2019 Agreement) with Norbrook. The 2019 Agreement replaced and superseded the 2015 Agreement in its
entirety. Under the 2019 Agreement, Norbrook provided the formulation, aseptic filling and final packaging services as required in order
for us to submit the CMC Technical Section to the FDA. The 2019 Agreement also provides for Norbrook to perform formulation, aseptic filling
and final packaging services in accordance with purchase orders that we submit from time to time for inventory build and subsequent product
sales worth up to approximately $7 million for orders placed through December 31, 2021 with deliveries extending into the first half of
2022. Under an amendment to this agreement, Norbrook has agreed to provide a supply of product during 2022 that we believe will enable
us to commence sales of Re-Tain®without delay upon receipt of the
anticipated FDA approval and provide us with a supply bridge until our own formulation and aseptic filling capacity is available.
Our potential
alternative third-party options for the formulation and aseptic filling services that are presently being performed by Norbrook are narrowed
considerably because our product cannot be formulated or filled in a facility that also processes traditional antibiotics (i.e., beta
lactams). Consequently, we have decided to perform these services internally. Through a public offering of our common stock in March of
2019, we received net proceeds of approximately $8.3 million, of which approximately $4 million has been allocated to the equipping and
commencement of operations of our own DP formulation and aseptic filling facility. We began equipment installation at the beginning of
2022, and we expect to have our facility operational during the middle of 2022. We anticipate FDA approval of this facility (which is
a requirement for commercial manufacturing) during the second half of 2023, subject to the timing of our installation and validation work
and whether the FDA requires more than one six-month review cycle. This new facility will be subject to FDA inspection and approval and
will have enough formulation and aseptic filling capacity to exceed the expected production capacity of our DS facility, which is at least
$10 million in annual sales. This production capacity estimate is based on our assumptions as to product pricing and does not yet reflect
inventory build strategies in advance of product approval or ongoing yield improvement initiatives. Establishing our own DP formulation
and aseptic filling capability provides us with the longer-term advantage of controlling the manufacturing process for Re-Tain®in one facility, thereby potentially reducing our manufacturing costs and eliminating international cold
chain shipping logistics and costs. The DP formulation and aseptic filling operation will be located in existing facility space that we
had intended to utilize to double our DS production capacity if warranted by sales volumes following market launch. As a result, we would
need to explore alternative strategies (in parallel with ongoing DS yield improvement initiatives) to expand our DS production capacity.
This integrated manufacturing capability for Re-Tain®will substantially
reduce our dependence on third parties. Upon completion of our formulation and aseptic filling facility, the only significant third-party
input for Re-Tain®will be the DP syringes. It is anticipated that
Hubert De Backer of Belgium (HDB) will supply these syringes in accordance with purchase orders that we submit. HDB is a syringe supplier
for many of the largest participants in the human and veterinary medical industries, and with whom Norbrook presently works. Based on
HDB’s performance history and reputation in the industry, we are confident that HDB will be a dependable supplier of syringes in
the quantity and of the quality needed for Re-Tain®.
32
ImmuCell Corporation
Our DS
manufacturing facility and that of our DP contract manufacturer are subject to ongoing FDA inspections. During the third quarter of 2019,
the FDA conducted a pre-approval inspection of our DS facility. This resulted in the issuance of certain deficiencies as identified on
the FDA’s Form 483. We submitted responses and data summaries in a phased manner over the fourth quarter of 2019 and first quarter
of 2020. We anticipate a reinspection by the FDA prior to approval. This inspection process has been managed without significant cost.
Other product development initiatives:
Our second most important product development initiative has been focused on other improvements, extensions
or additions to our First Defense® product line. We are currently working to establish USDA claims for our bivalent
bulk powder formulation of First Defense Technology®. At the same time, we are working with outside parties to investigate
improvements to our Nisin DS production yields as well as potential efficacy enhancements. Subject to the availability of resources, we
intend to begin new development projects that are aligned with our core competencies and market focus. We also remain interested in acquiring,
on suitable terms, other new products and technologies that fit with our sales focus on the dairy and beef industries, subject to the
availability of the needed funding.
Sales and Marketing Expenses
During the year ended December 31, 2021, sales
and marketing expenses increased by approximately 16%, or $336,000, to $2.5 million in comparison to $2.2 million during the year ended
December 31, 2020, amounting to 13% and 14% of product sales during the years ended December 31, 2021 and 2020, respectively. Sales and
marketing expenses included approximately $70,000 and $91,000 of non-cash depreciation and stock-based compensation expenses during the
years ended December 31, 2021 and 2020, respectively. We do expect these expenses to increase to approximately 20% of total product sales
during 2022 as we begin to invest in the anticipated market launch of Re-Tain®
before any new sales are realized and as in-person marketing opportunities, such as industry events, return with the lifting of COVID
restrictions. Our budgetary guideline for 2022 and after is to keep these expenses under 20% of total sales. We continue to leverage the
efforts of our small sales force by using animal health distributors.
Administrative Expenses
During the year ended December 31, 2021, administrative
expenses increased by less than 1%, or approximately $5,000, to $1.726 million in comparison to $1.721 million during the year ended December
31, 2020. Administrative expenses included approximately $122,000 and $156,000 of non-cash depreciation and stock-based compensation expenses
during the years ended December 31, 2021 and 2020, respectively. We strive to be efficient with these expenses while funding costs associated
with complying with the Sarbanes-Oxley Act of 2002 and all the legal, audit and other costs associated with being a publicly-held company.
Prior to 2014, we had limited our investment in investor relations spending. Beginning in the second quarter of 2014, we initiated an
investment in a more active investor relations program. Given travel restrictions related to the COVID-19 pandemic, this initiative has
pivoted to a virtual meeting format, which is less expensive. At the same time, we continue to provide full disclosure of the status of
our business and financial condition in three quarterly reports and one annual report each year, as well as in Current Reports on Form
8-K when legally required or deemed appropriate by management. These efforts may have helped us access the capital markets to fund our
growth objectives.
Net Operating Income (Loss)
During the year ended December 31, 2021, our
net operating income of $257,000 was in contrast to a net operating (loss) of ($1.4 million) during the year ended December 31, 2020.
The $1.8 million increase in gross margin during the year ended December 31, 2021 compared to the year ended December 31, 2020 was the
largest contributor to this swing from loss to income.
33
ImmuCell Corporation
Other Expenses (Income),
net
During the year ended December 31, 2021 other
expenses, net, aggregated $327,000 in contrast to other income, net, of $348,000 during the year ended December 31, 2020. The 2020 results
benefited from a $938,000 debt forgiveness from the federal government. Interest
expense decreased to $314,000 during the year ended December 31, 2021 from $413,000 during the year ended December 31, 2020. Non-cash
amortization of debt issuance costs (which is included as a component of interest expense) was $8,000 during both of the years ended December
31, 2021 and 2020. During the year ended December 31, 2020, interest expense also included the non-cash write-off of $95,000 in debt issuance
costs associated with our bank debt refinancing during the first quarter of 2020. Excluding the amortization and write-off of debt issuance
costs, cash-based interest expense decreased slightly to $307,000 during the year ended December 31, 2021 from $310,000 during the year
ended December 31, 2020. Other expenses, net, during the year ended December 31, 2020 included an expense of $165,000 to terminate
our interest rate swap agreements associated with our bank debt refinancing during the first quarter of 2020. Reflecting the mortgage
debt financing we completed during the first quarter of 2022, we anticipate that our interest expense will be approximately $325,000,
$317,000 and $285,000 during the years ending December 31, 2022, 2023, and 2024, respectively. Interest
income was $19,000 and $27,000 during the years ended December 31, 2021 and 2020, respectively. Less interest income was earned
during 2021 largely because we had less cash and short-term investments on hand and a lower interest rate environment. The
annual results included a net loss of $31,000 and $39,000 related to the non-cash write-offs of fixed assets during the years ended December
31, 2021 and 2020, respectively.
Loss Before Income Taxes
During
the year ended December 31, 2021, our loss before income taxes decreased by 93%, or $963,000, to ($69,000) in comparison to a loss before
income taxes of ($1 million) during the year ended December 31, 2020.
Income Taxes and Net Loss
During the years ended December 31, 2021 and
2020, we recorded income tax expense (benefit) of $9,000 and ($10,000), respectively. Our net loss of ($78,000), or ($0.01) per basic
share, during the year ended December 31, 2021 was in comparison to a net loss of ($1 million), or ($0.14) per basic share, during the
year ended December 31, 2020.
For tax return purposes only, our depreciation
expense for the Nisin Drug Substance production facility and equipment was approximately $492,000, $464,000, $639,000, $9.2 million and
$1.5 million for the years ended December 31, 2021, 2020, 2019, 2018 and 2017, respectively. The significant increase during 2018 was
largely related to accelerated depreciation allowed for tax purposes. As of December 31, 2021, our federal net operating loss carryforward
was approximately $14.7 million, which will be available to offset future taxable income. On December 22, 2017, the Tax Cuts and Jobs
Act was signed into law. This legislation makes significant changes in the U.S. tax laws, including a reduction in the corporate tax rates,
changes to net operating loss carryforwards and carrybacks, and a repeal of the corporate alternative minimum tax. The legislation reduced
the U.S. corporate tax rate from 34% to 21%. Our income tax rate differs from this standard tax rate primarily because we are currently
providing for a full valuation allowance against our deferred tax assets. While we are recording this full valuation allowance, we are
not recognizing the benefit of our tax losses.
In addition to the above results from our Statements
of Operations, we believe it is important to consider our Statements of Cash Flows in the accompanying audited financial statements to
assess the cash generating ability of our operations.
Critical Accounting Policies
The financial statements are presented on the
basis of accounting principles that are generally accepted in the United States. All professional accounting standards that were effective
and applicable to us as of December 31, 2021 have been taken into consideration in preparing the financial statements. The preparation
of financial statements requires that we make estimates and judgments that affect the reported amounts of assets, liabilities, revenues
and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including
those related to revenue recognition, income taxes, contingencies and the useful lives and carrying values of intangible and long-lived
assets. We base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent
from other sources. Actual results may differ from these estimates under different assumptions or conditions. We have chosen to highlight
certain policies that we consider critical to the operations of our business and understanding our financial statements.
34
ImmuCell Corporation
We sell products that provide Immediate ImmunityTM
to newborn dairy and beef cattle. We recognize revenue in accordance with the five step model in ASC 606. These include the following:
i) identification of the contract with the customer, ii) identification of the performance obligations in the contract, iii) determination
of the transaction price, iv) allocation of the transaction price to the separate performance obligations in the contract and v) recognition
of revenue associated with performance obligations as they are satisfied. We recognize revenue at the time of shipment (including to distributors)
for substantially all products, as title and risk of loss pass to the customer on delivery to the common carrier after concluding that
collectability is reasonably assured. We do not bill for or collect sales tax because our sales are generally made to distributors and
thus our sales to them are not subject to sales tax. We generally have experienced an immaterial amount of product returns.
Inventory includes raw materials, work-in-process
and finished goods and is recorded at the lower of cost, on the first-in, first-out method, or net realizable value (determined as the
estimated selling price in the normal course of business, less reasonably predictable costs of completion, disposal and transportation).
Work-in-process and finished goods inventories include materials, labor and manufacturing overhead.
ITEM 7A — QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT
MARKET RISK
We do not believe that inflation, interest rates
or currency exchange rates have had a significant effect on our revenues and expenses. However, future increases in inflation or interest
rates or the value of the U.S. dollar could affect our customers and the demand for our products. We hope to increase the level of our
future sales of products outside the United States. The cost of our products to international customers could be affected by currency
fluctuations. The decline of the U.S. dollar against other currencies could make our products less expensive to international customers.
Conversely, a stronger U.S. dollar could make our products more costly for international customers. The current devaluation of the dollar
makes Euro-based purchases more expensive for us. We had outstanding bank debt totaling approximately $9.1 million as of December 31,
2021 that bears interest at the fixed rate of 3.50% per annum. Also, as of December 31, 2021, we had two subordinated loans from the State
of Maine outstanding aggregating $900,000. The first loan bears no interest until the fourth quarter of 2022, at which time it bears interest
at a fixed rate of 5% per annum, unless it is repaid. The second loan bears no interest until the third quarter of 2023, at which time
it bears interest at a fixed rate of 5%, per annum, unless it is repaid. See Note 10 to the accompanying audited financial statements
for more details about our debt.
ITEM 8 — FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Our financial statements, together with the notes
thereto and the reports of the independent registered public accounting firms thereon, are set forth on Pages F-1 through F-26 at the
end of this report. The index to these financial statements is as follows:
Statements of Operations during the years ended December 31, 2021 and 2020 F-3
Notes to Audited Financial Statements F-7 to F-26