ICCC 10-K & 10-Q changes, risk factors and insider trading
Immucell Corp. · Nasdaq · In Vitro & In Vivo Diagnostic Substances · CIK 811641 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Removed heading “OUTLINE TO ITEM 1A – RISK FACTORS”
Largest changes
“Inflation, supply disruptions, tax rates and economic downturns: Inflation is having a material and adverse impact on almost all supplies we purchase and labor we hire and retain. Continuing or increasing inflationary trends could materially reduce our gross margin on product sales if we are unable or unwilling to impose offsetting price increases on our customers. The extent and duration of the negative impact on the economics of our customers and on the demand for our products going forward are very difficult to assess. …”see in full comparison
“Milk price: The dairy market, similar to many others, has been unstable for several reasons including as a result of the pandemic. The price paid to producers for milk has been very volatile. This market volatility, and the resulting impact on our primary end users, could negatively impact our ability to maintain and grow sales at a profitable level. The Class III milk price (an industry benchmark that reflects the value of product used to make cheese) is an important indicator because it defines our customers’ revenue level. …”see in full comparison
“Inflation, supply disruptions, tax rates and economic downturns: Cumulative inflation over the past five years has materially increased the price of almost all supplies we purchase and the labor we hire and retain. The cost of grain and other inputs for our customers has risen over that period, putting strain on the profitability of our customers. On the other hand, calf prices have increased significantly since 2020, which we believe makes spending on scours prevention more attractive. If the U.S. …”see in full comparison
“Industry: We define our addressable market for First Defense® as the number of calves currently or potentially protected by scours preventative products multiplied by the value paid for such products. A significant decline in the cattle count would negatively affect the size of our addressable market by reducing the number of animals that would benefit from scours preventatives. …”see in full comparison
Debt covenants: Our debt with Maine Community Banksee in full comparison(formerly Gorham Savings Bank) and the Finance Authority of Maineis subject to certain financial covenants. We are required to meet a minimum debt service coverage (DSC) ratio of 1.35. Our actual DSC ratios were0.73, (1.10), 0.44, 2.682.65 and2.030.73 for the years ended December 31,2024, 2023, 2022, 20212025 and2020,2024, respectively.During the first quarter of 2023, theThe DSC ratio covenantfor the year ended December 31, 2023was preemptively waived by ourlender. Instead, we were required to meet a minimum DSC ratio requirement of 1.35lenders for thetwelve-monthtwelve months periods ended June 30, 2024, September 30, 2024 and December 31,2024,2024.and then again annually after that. During the first quarter of 2024, the DSC ratio covenant for the twelve-month period ended June 30, 2024 was preemptively waived by our lenders. During the third quarter of 2024, the DSC ratio covenant for the twelve-month period ended September 30, 2024 was preemptively waived by our lenders. During the fourth quarter of 2024, the DSC ratio covenant for the twelve-month period ended December 31, 2024 was preemptively waived by our lenders. Our next compliance obligation is for the year ending December 31, 2025.There is no assurance that we will be able to achieve the required DSC ratio going forward. If we are unable to do so or reach a favorable agreement with our lenders regarding that requirement (including an amendment to or waiver of such requirement), we would be in violation of that covenant, which could result in unfavorable amendments to the terms of our bank debt (including a possible bank requirement to prepay our debt) or have other adverse impacts on our business and results of operations.
“Gross margin on product sales: We consider gross profit as a percentage of product sales (gross margin) to be a key measure of our overall efficiency of production and of our ability to maintain favorable pricing of our products. Between 2024 and 2025, we saw a substantial recovery of gross margin, from 30% to 41% of product sales, with the latter percentage materially affected by a non-cash write-down of inventories representing approximately 2.4% of product sales for the year ended December 31, 2025. Many factors affect our costs of goods sold and therefore impact gross margin. …”see in full comparison
Full comparison: every changed paragraph (53)
We caution you that our business and operations are subject to a number of risks and uncertainties. The factors listed below are important factors that could cause our actual results to differ materially from our historical results and from projections in forward-looking statements contained in this report. Other factors that we do not anticipate, or that we do not consider material based on currently available information, may also have an adverse effect on our results.
OUTLINE
TO ITEM 1A – RISK FACTORS
Gross margin on product sales: We consider gross profit as a percentage of product sales (gross margin) to be a key measure of our overall efficiency of production and of our ability to maintain favorable pricing of our products. Between 2024 and 2025, we saw a substantial recovery of gross margin, from 30% to 41% of product sales, with the latter percentage materially affected by a non-cash write-down of inventories representing approximately 2.4% of product sales for the year ended December 31, 2025. Many factors affect our costs of goods sold and therefore impact gross margin. There is a risk that efforts to maintain or improve our gross margin may not be realized due to distributor or end-customer price inelasticity, lack of colostrum supply or increased colostrum costs, other cost increases, production yield losses, in-process contamination events, equipment failures, or any combination of these factors.
Product sales: We will seek to expand our First Defense® product sales by increasing the share of calves in the U.S. using our products and by seeking to enter non-U.S. markets where we presently have little or no presence. We have increased our investment in our commercial staff. The markets for calf scours preventatives and treatments are highly competitive. First Defense® typically has a higher price per application than vaccine products against which we compete, reflecting what we consider to a higher level of efficacy. There is no assurance that our increased sales efforts in domestic markets or our attempts to enter new international markets will result in higher product sales. Our efforts to expand into international markets also may be constrained by difficulties in achieving necessary regulatory approvals for our products in that country.
Net income (loss): In 2025 we achieved a significant increase in net operating income, amounting to $1.6 million versus a $1.6 million net operating loss for 2024. Our future financial performance can be affected by numerous factors that are difficult to predict or that are beyond our control.
Gross
margin on product sales: One of our goals is to achieve a gross margin as a percentage of total sales of 40% or more (including depreciation
expense) after the initial launch of new products. Depreciation expense will be a larger component of costs of goods sold for Re-Tain®
than it is for the First Defense® product line. Gross margins generally improve over time, but this anticipated
improvement may not be realized for Re-Tain®. Many factors discussed in this Annual Report (including contaminations,
process yields, inflation, cost increases, supply-chain disruptions and the rising price of oil and other commodities and supplies) impact
our costs of goods sold. There is a risk that we are not able to achieve our gross margin goal, which would adversely affect our operating
results and could impact our future operating plans. We missed our gross margin goal during the years ended December 31, 2024 and 2023
with realized gross margins of 30% and 22%, respectively. There is a risk that our plans to maintain or improve our gross margin may
not be realized due to cost increases, production yield losses, additional manufacturing contamination events, production equipment failures,
price inelasticity or any combination of these factors. In addition, such negative events, depending on their severity, could deplete
our cash resulting in an inability to fund our business.
Exposure
to interest rates and debt service obligations: Rising interest rates could negatively affect the operating costs of dairydistributors and beef
producers and thus put further financial pressure on andairy alreadyand stressedbeef business sector,sectors, which could indirectly, but materially and
adversely, affect our business. IncreasesOur inaggregate interest rates since 2020 have had only limited effect on our direct cost of borrowing.
During the first quarter of 2020, we refinanced our bankoutstanding debt (with the exception of our line of credit) with fixed rate notes. Our mortgage
debt outstanding as of December 31, 20242025 wastotaled $5.6$9.1 million bearing(without interest at the fixed rate of 3.53% per annum. Our equipment loans
outstanding as of December 31, 2024 were $1.9 million bearing interest at the fixed rate of 3.50% per annum. The outstanding balance
on the two State of Maine loans as of December 31, 2024 was approximately $592,000 bearing interest at the fixed rate of 5% per annum.
The $3 million incounting debt thatissuance weand borroweddebt duringdiscount the third quarter of 2023 (which had an outstanding balance of approximately $2.5 million
as of December 31, 2024costs) bearsbearing interest at the blended fixed rate of 7.33% per annum illustrating the effect of rising interest rates.
Our outstanding debt as of December 31, 2024 aggregating $10.6 million (gross of debt issuance and debt discount costs) bears interest
at the blended fixed rate of 4.51%4.31% per annum. Increasing interest rates would negatively impact the cost of any future borrowings. This
was experienced on the new debt facilities aggregating $3 million that we closed during the third quarter of 2023. The additional debt
we incurred to fund our growth objectives has significantly increased our total debt service costs. We are obligated to make principal
and interest payments aggregating approximately $2 million and $3.7$1.5 million during the years ending December 31, 20252026 and 2026,2027, respectively.
See Note 9 to the accompanying audited financial statements for more details about our debt. A decline in sales or gross margin, coupled
with this debt service burden, could impair our ability to fund our capital and operating needs and objectives.
Debt
covenants: Our debt with Maine Community Bank (formerly Gorham Savings Bank) and the Finance Authority of Maine is subject to certain
financial covenants. We are required to meet a minimum debt service coverage (DSC) ratio of 1.35. Our actual DSC ratios were 0.73, (1.10),
0.44, 2.682.65 and 2.030.73 for the years ended December 31, 2024, 2023, 2022, 20212025 and 2020,2024, respectively. During the first quarter of 2023,
theThe DSC ratio covenant for the year ended December 31, 2023 was preemptively waived by our lender. Instead, we were required to meet
a minimum DSC ratio requirement of 1.35lenders for the twelve-monthtwelve months periods ended June 30, 2024, September 30, 2024 and December 31, 2024,2024. and
then again annually after that. During the first quarter of 2024, the DSC ratio covenant for the twelve-month period ended June 30, 2024
was preemptively waived by our lenders. During the third quarter of 2024, the DSC ratio covenant for the twelve-month period ended September
30, 2024 was preemptively waived by our lenders. During the fourth quarter of 2024, the DSC ratio covenant for the twelve-month period
ended December 31, 2024 was preemptively waived by our lenders. Our next compliance obligation is for the year ending December 31, 2025.
There is no assurance that we will be able to achieve the required DSC ratio going forward. If we are unable to do so or reach a favorable
agreement with our lenders regarding that requirement (including an amendment to or waiver of such requirement), we would be in violation
of that covenant, which could result in unfavorable amendments to the terms of our bank debt (including a possible bank requirement to
prepay our debt) or have other adverse impacts on our business and results of operations.
Currency
exchange fluctuation: We do not believe that currency exchange rates have had a significant effect on our revenues and expenses.
However, particularly if we expand non-U.S. sales of First Defense® future increases in the value of the U.S. dollar could affectmake our products more expensive for our non-U.S. customers and theaffect 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. TheConversely, 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. A weaker U.S. dollar makes
international purchases more expensive for us.
Inflation, supply disruptions, tax rates and economic downturns: Cumulative inflation over the past five years has materially increased the price of almost all supplies we purchase and the labor we hire and retain. The cost of grain and other inputs for our customers has risen over that period, putting strain on the profitability of our customers. On the other hand, calf prices have increased significantly since 2020, which we believe makes spending on scours prevention more attractive. If the U.S. economy were to experience an extended period of economic downturn, we expect this could have a corresponding negative effect on our business and operations, including the supply of the colostrum we purchase to produce our First Defense® product line, the demand for our products in the U.S. market, and our ability to penetrate or maintain a profitable presence in international markets.
Business interruption and business continuity: Our business interruption insurance may not be adequate to cover our potential losses, liabilities and damages. Furthermore, we may be subject to business continuity risk in the event of an unexpected loss of a material facility or operation. Our product operations are concentrated at a single location, which exposes us to significant business interruption risk if that facility is damaged or otherwise unavailable. Although we maintain insurance coverage intended to protect against certain losses; waiting periods, deductibles, and exceptions could materially reduce or eliminate recovery for certain events. We pursue risk mitigation measures and periodically review our insurance programs, but these steps may not be sufficient to eliminate the risks described above or to prevent a material adverse effect on our business.
Inflation,
supply disruptions, tax rates and economic downturns: Inflation is having a material and adverse impact on almost all supplies we
purchase and labor we hire and retain. Continuing or increasing inflationary trends could materially reduce our gross margin on product
sales if we are unable or unwilling to impose offsetting price increases on our customers. The extent and duration of the negative impact
on the economics of our customers and on the demand for our products going forward are very difficult to assess. The dairy market, similar
to many others, has been unstable as a result of the pandemic. The price paid to producers for milk has been very volatile. The Class
III milk price has been extremely volatile since the onset of the pandemic. Market conditions have improved somewhat, but this volatility
remains a concern. Additionally, like most input costs, the cost of grain and other feed is rising, which puts a strain on the profitability
of our customers. There is also economic uncertainty for beef producers, as the supply chain is interrupted or otherwise adversely affected
due to closures of processing plants and reduced throughput. This is a very unusual situation for farmers who work so hard to improve
production quality and efficiency in order to help feed a growing population with high-quality and cost-effective proteins. The pandemic
created risk and continues to create uncertainty and challenges for us and has created or contributed to global supply-chain disruptions
and has affected international trade, while creating a worldwide health and economic crisis. Stock market valuations have declined and
recovered somewhat but remain very volatile. Inflation has increased significantly, and tax rates may increase. There is a risk of a
period of economic downturn, the severity and duration of which are difficult to know. Prior to the pandemic and the responsive federal
economic stimulus programs, many feared the United States had taken on too much national debt. Now the debt load is significantly higher.
A combination of the conditions, trends and concerns summarized above could have a corresponding negative effect on our business and
operations, including the supply of the colostrum we purchase to produce our First Defense® product line, the demand
for our products in the U.S. market and our ability to penetrate or maintain a profitable presence in international markets. Our exposure
to this risk is mitigated to some extent by the fact that our supply chain is not heavily dependent on foreign manufacturers, by our
on-going cross-training of our employees, by qualifying alternate suppliers and components and by our early and continued compliance
with recommended hygiene.
Projection
of net (loss) income: Generally speaking, our financial performance can differ significantly from management projections, due to
numerous factors that are difficult to predict or that are beyond our control. Weaker than expected sales of the First Defense®
product line could lead to deeper operating losses or less profits. The timing of FDA approval of Re-Tain®
will continue to have a material impact on our net (loss) income until sufficient commercial sales are generated and sustained, unless
we adequately reduce product development expenses.
Risks
associated with our funding strategy for Re-Tain®: The inability to maintain adequate cash and
liquidity to support the commercialization of Re-Tain® is a risk to our business. Achieving FDA approval of our
pharmaceutical-grade Nisin produced at commercial-scale is the most critical action remaining in front of us on our path to U.S. regulatory
approval of Re-Tain®. Having completed the construction and equipping of the DS production facility (as described
in more detail in PART I: ITEM 2 of this Annual Report) at a cost of approximately $20.8 million, we will continue to incur product
development expenses to operate and maintain this facility until commercialization, although we are reducing these expenses now that
production of inventory for our Controlled Launch is complete.
Uncertainty
of market size and product sales estimates: Estimating the size of the total addressable market and future sales growth potential
for our First Defense® product line is based on our experience and understanding of market dynamics but is inherently
subjective. Estimating the size of the market for any new product, such as Re-TainFirst Defense Technology®, involves more uncertainties
than do projections for established products. We do not know whether, or to what extent, our products will achieve, maintain or increase
market acceptance and profitability. Some of the uncertainties surrounding Re-TainFirst Defense Technology® include the product’s
effectiveness against currently prevalent pathogens, market acceptance, the effect of a premiumour selling price on market penetration,
cost ofthe manufacture,potential cannibalization effect on other First Defense® products, competition from new and existing products sold by substantially larger competitors with greater market reach and
promotional resources and other risks described under “Product Risks” – “Sales risks pertaining to Re-Tain®”
below. Since Re-Tain® is a novel approach to treating mastitis, there are many uncertainties with regards to how
quickly and to what extent we can develop the subclinical mastitis treatment market. We believe that polypeptide antimicrobial technology
may be viewed positively (relative to traditional antibiotics). If realized, this may offset some of these risks and result in better
overall market acceptance.risks.
Product
risks generally: We set objectives for our products that we believe we can achieve, but the achievement of such goals is not a certainty.
The sale of our products is subject to production, financial, efficacy, regulatory, competitive and other market risks. Elevated standards
to achieve and maintain regulatory compliance required to sell our products continue to evolve. Failure to achieve acceptable biological
yields from our production processes can materially increase our costs of goods sold and reduce our production output, leading to lower
margins and/or an order backlog that could adversely affect our customer relationships and operating results. First Defense®
is sold, and we expect Re-Tain® to be sold,sold at significant price premiums relative to competitive products.
There is no assurance that we will continue to achieve market acceptance of the First Defense® product line, or
achieve and sustain market acceptance of Re-Tain®,line at a profitable price level or that we can continue to manufacture
our products at a low enough cost to result in a sufficient gross margin to justify their continued manufacture and sale. As we bring
Re-Tain® to market, theseThese risks could be heightened by the additional uncertainties associated with introducing
a new product requiring a shift in customer behavior.
Contamination
events, equipment failures and gross margin from our production process: During the first three and a half months of 2024 as well
as during 2023 and late 2022, we experienced certain contamination events and equipment failures in our production process that resulted
in scrapped inventory and a slowdown of our production process, which had a significant negative impact on our operating results. The
realization of this risk following the contamination events discussed above did result in a slowdown of our production output during
2023 to remediate this problem, which led to less sales and gross margin during the year. We are at risk of further such production contaminations
or equipment failures resulting in more scrapped inventory. Additional contamination events or equipment failures causing significantly
less production output, depending on their severity, could deplete our cash resulting in an inability to fund our business operations.
Sales
risks pertaining to Re-Tain®: Actual or prospective Re-Tain® customers
may decide to discontinue, reduce or avoid usage of Re-Tain® due to the following risks:
1)
A rejection of a tank of milk by a positive milk inhibitor test because too much of the milk in a bulk tank is comprised of milk from
cows being treated with Re-Tain®, when tested randomly for inhibitors by a milk hauler, which could create legal
liability.
2)
A failed or stalled cheese tank occurs when a Nisin susceptible cheese starter culture is impacted by residues in milk that exceed our
on-farm treatment recommendations, which aims to limit concentrations of bulk tanks or tankers to 1% of milk from cows treated with Re-Tain®
or is not effectively diluted through the milk collection and transportation system. After we study this potential impact during
our Controlled Launch of Re-Tain®, we may decide to seek a post-approval label change requiring a short discard
of milk, which may be limited to just the treated quarter of the cow.
3)
Producers’ current practice generally is to treat only clinical mastitis, which has the visual indicator of abnormal milk. In order
to gain market penetration for Re-Tain®, we will need to change that practice and increase awareness of the importance
of treating subclinical disease. This will require the producers’ ability and willingness to diagnose without visual indicators.
Users of Re-Tain® could have unsatisfactory treatment outcomes if they lack the equipment needed to measure and
monitor somatic cell counts (SCC) of the herd or individual cows (for which data is needed). This risk limits our access to treatment
cows because about 40% of farms do not presently have access to this kind of testing at the cow level, and thus are not good candidates
for the use of Re-Tain®.
4)
Lower than anticipated treatment cure rates could be experienced because the product is administered to cows that we would not identify
as the best treatment candidates based on SCC data or because the product is administered to cows that are infected with pathogens outside
of our label claims.
5)
Off-label use of our product in cows infected with clinical mastitis before we have run the required studies and achieved a label claim
extension for this disease state, resulting in negative treatment outcomes and potential legal liability.
6)
Producers either do not choose to use it or might use it improperly, rather than follow our label instructions to administer one dose
after each of three consecutive milkings, or they may limit use within the herd in an abundance of caution to avoid the negative outcomes
described above.
7)
Our agreement to have DP filled by our current contract manufacturer expired in November of 2024. However, this agreement does provide
for ongoing product labeling and packaging through the first quarter of 2026. Based on the anticipated best-case product expiration dating
for Re-Tain®, we could have inventory available for sale into the first quarter of 2026. We would need to secure
a new DP manufacturing agreement, or bring the process in-house, to fill more inventory after that.
Reliance
on sales of the First Defense® product line: We presently are reliant on the market acceptance of the First
Defense® product line to generate product sales and fund our operations. Our business would not have beenbe profitable
during the years ended December 31, 2012, 2013, 2015 and 2016, during the nine-month periods ended September 30, 2017 or during the three-month
periods ended March 31, 2019, December 31, 2020, June 30, 2021, September 30, 2021, December 31, 2021, March 31, 2022 and December 31,
2024 without the gross margin that we earnedearn on sales of the First Defense® product line. Our anticipatedability return
to profitabilityachieve isnet contingentoperating uponincome thein 2025 was largely driven by gross margin we earnearned from First Defense® and prudent management of product
development expenses.
Concentration
of sales: Sales of the First Defense® productline lineof products aggregated 99% of our total product sales during both of
the years ended December 31, 20242025 and 2023.2024. Our primary customers for theThe majority of our product sales (86%is and 91% during the years
ended December 31, 2024 and 2023, respectively), are infrom the U.S. dairy and beef industries.industries The(approximately 88% and 86% during the years ended December 31, 2025 and 2024, respectively), and the concentration of our sales from one product
into just two markets (the dairy and beef markets) is a risk to our business. The animal health distribution segment has been aggressively
consolidating over the last few years, with larger distributors acquiring smaller distributors. A large portion of our product sales
(77%approximately 72% and 79%77% during the years ended December 31, 20242025 and 2023,2024, respectively), was made to two large distributors.distributors Aand a large portion of
our trade accounts receivable (78%approximately 69% and 79%78% as of December 31, 20242025 and 2023,2024, respectively) was due from these two distributors. We have
a good history with these distributors, but the concentration of sales and accounts receivable with a small number of customers does
present a risk to us, including risks related to such customers experiencing financial difficulties or altering the basis on which they
do business with us in a manner unfavorable to us.
Production
capacity constraints: The inability to meet market demand for our products is a risk to our business. We invested $9.9$11.0 million from 2019 to December 31, 20242025 to increase our annual production capacity (in terms
of annual sales dollars) for the First Defense® product line from approximately $16.52.2 million manufactured units in 2018 to approximately
$30 4.6 million ormanufactured moreunits basedin on2025. currentOur selling prices and estimated production yields. We are making initialfuture plans tocall furtherfor increase
increases of our production capacity.capacity Whilethrough previousyield improvements and by redeploying assets previously slated for production of Re-Tain®. Expanding manufacturing capacity expansioninvolves investmentspractical haveand proceededtechnical veryrisks closeaffecting efficiency of production, risks of contamination, and risks of not being able to budget,access theresufficient high-quality colostrum needed for this process. There is a risk of cost overruns
in our ongoing projects and any future production expansions that we may undertake, and a risk that we will not be able to achieve our
production capacity growth objectives on a timely basis, resulting in a continuing or increasing shortfall in supply to the market. The
inability to meet market demand for our products is a risk to our business. The historically largeA backlog of orders, as well as any
ongoing order backlog,orders presents a risk that we could lose customers during this period that are not easily regained thereafter, when
our production capacity is expected to meet or exceed sales demand.regained. Our long-term capital plan to continue to expand the First Defense®
product line requires ongoing review of equipment capacity and utilization across the manufacturing value stream at Building
56 and our leased facilities at Building 175A and 175B, as well as assessment of costs, functional obsolescence and
reliability of equipment. This review and assessment could identify a need to fund unexpected equipment maintenance or replacement costs.
Contamination events, equipment failures and gross margin from our production process: During the first three and a half months of 2024, as well as during 2023 and late 2022, we experienced certain contamination events and equipment failures in our production process that resulted in scrapped inventory and a slowdown of our production process, which had a significant negative impact on our operating results. The realization of this risk following the contamination events discussed above did result in a slowdown of our production output during 2023 to remediate this problem, which led to less sales and gross margin during the year. We are at risk of further such production contaminations or equipment failures resulting in more scrapped inventory. Additional contamination events or equipment failures causing significantly less production output, depending on their severity, could deplete our cash resulting in an inability to fund our business operations. Recent losses incurred from contamination events in 2022 through early 2024 were only partially offset by business interruption insurance recoveries in 2023 and 2025.
Colostrum collection: There is a risk that the farms that participate in our vaccination and colostrum collection process no longer wish to continue supplying us with colostrum or participating in our vaccination program, due to the need to use all or part of the colostrum for their own calves and concerns with the increasing cost of colostrum-replacement. There is a risk that our supply farms, which are almost entirely located in one state, are subject to a disease outbreak that inhibits their ability to supply the colostrum. There is a risk that other companies will offer higher premiums for colostrum for use in human or other animal health markets. There is a risk that the quality of the colostrum collected will not be suitable for our production requirements.
Risks pertaining to Re-Tain®: In late 2025 we made the decision not to pursue manufacture of Re-Tain® and to attempt to license this technology to other companies, or to sell to or partner with other companies. There is no assurance that we will be able to find third parties who have an interest to in-license, acquire or partner with us related to Re-Tain®. Parties may not be interested if they perceive that (1) completing the process of obtaining FDA and international regulatory approvals is too burdensome, too costly, or takes too much time, (2) positive milk inhibitor tests involve risk of rejection of bulk tanks of milk comprised of milk from cows being treated with Re-Tain®, (3) cheese tanks fail or stall when a Nisin susceptible cheese starter culture is impacted by residues in milk that exceed on-farm treatment recommendations, (4) dairy farms will choose not to screen for subclinical mastitis (instead focusing on treating clinical mastitis that can be identified visually), (5) dairy farms are unable to judge satisfactory treatment outcomes due to lack of equipment to measure and monitor somatic cell counts (SCC) of the herd or individual cows, (6) cure rates established in scientific trials prove less than desired, or (7) dairy farms choose not to use Re-Tain® or use it improperly, rather than follow label instructions.
Regulatory
requirements for the First Defense® product line: First Defense® is sold in the United
States subject to a product license from the Center for Veterinary Biologics, USDA, which was first obtained in 1991, with subsequent
approvals of line extensions in 2017 and 2018. As a result, our operations are subject to periodic inspection by the USDA, and we are
at risk of an unfavorable outcome from such inspections. The potency of serial lots is directly traceable to the original serial used
to obtain the product performance claims (the Reference Standard). Due to the unique nature of the label claims, host animal re-testing
is not required as long asif periodic laboratory analyses continue to support the stability of the stored Reference Standard. To date,
these analyses have demonstrated strong stability. However, if the USDA were not to approve requalification of the Reference Standard,
additional clinical studies could be required to meet regulatory requirements and allow for continued sales of the product, which could
interrupt sales and adversely affect our operating results. Territories outside of the United States may requirehave additional regulatory
oversight requirements that we may not be able to meet with our current facilities, processes and resources. There is a risk that we will become subject
to regulatory actions in the future, including actions that result in our inability to ship product. In these cases, the resulting interruption
in sales could have a material and adverse effect on our operating results.
Regulatory
requirements for Re-Tain®: Commercial introduction of this product in the United States requires
us to obtain FDA approval. Completing the process of obtaining FDA approval of the pending NADA involves risk. The regulatory development
process timeline has been extensive (approximately 17 years from when the product rights were returned to us by a former partner in 2007)
and has involved multiple commercial production strategies and multiple submissions of the Chemistry, Manufacturing and Controls (CMC)
Technical Section. We received an Incomplete Letter from the FDA regarding this CMC Technical Section during the third quarter of 2022
that clarified the required path to product approval. During May of 2024, we received an Incomplete Letter from the FDA in response to
our November of 2023 re-submission. To reduce the risk associated with this process, we are working with a qualified contract manufacturer
(Norbrook) for alignment of the required validations and DP manufacture and have met with the FDA to clarify filing strategy and requirements.
Early during the first quarter of 2024, the FDA conducted another pre-approval inspection of our DS facility. This resulted in the issuance
of one deficiency as identified on the FDA’s Form 483. Since then, we have cleared the inspectional observation with the FDA. However,
our efforts continue to be subject to inspection and approval by the FDA and other factors outside of our control, and there remains
a risk that the required FDA approvals of our product and facilities could be further delayed or not obtained. The facility of our contract
manufacturer is subject to similar inspectional obligations and is currently working to resolve certain inspectional observations at
their facility and is subject to re-inspection by the FDA. International regulatory approvals would be required for sales of Re-Tain®
outside of the United States, and there is a risk that these approvals would be or become too costly to pursue or be delayed
or not obtained.
ImmigrationDairy Staffing:
The U.S. government is stepping up deportationimmigration efforts,enforcement resultingefforts. inColostrum asuppliers risingto rateour manufacturing process or customers of deportations of criminals that are in our country
illegally.products Manymay farmsbe employchallenged hard-working,to non-criminalrecruit, train and retain employees who haveare notcritical yetfor achievedour legalcolostrum citizenship.supply process and use of our product in the field. Significant deportations
of these individuals could have a negative impact on the operations of our customers and of our source farms.
Industry: We define our addressable market for First Defense® as the number of calves currently or potentially protected by scours preventative products multiplied by the value paid for such products. A significant decline in the cattle count would negatively affect the size of our addressable market by reducing the number of animals that would benefit from scours preventatives. A significant decline in the value of newborn or pre-weaning calves would negatively affect the size of our addressable market by reducing the interest of producers to invest in calf health solutions, including scours preventatives. A multitude of factors can contribute to changes in the number of cattle or changes in the value of calves in any particular geography, including government decisions affecting trade of live animals, disease outbreaks and containment statuses, supply and demand imbalances for specific sources of protein such as milk and beef, changes in breeding and genetics practices, and other factors. Changes in milk and beef prices and feed costs may also impact producers' ability to pay for premium calf health products such as First Defense®.
The
industry data referred to below is compiled from USDA databases.
Cattle
count: The January count of all cattle and calves in the United States had steadily declined from 97,000,000 as of January 1, 2007
to 88,500,000 as of January 1, 2014. Then this figure increased each year, reaching 94,800,000 as of January 1, 2019 before declining
to 93,800,000 as of both January 1, 2020 and January 1, 2021. This count continued to decline to 92,100,000 as of January 1, 2022 and
to 88,800,000 as of January 1, 2023 and to 87,200,000 as of January 1, 2024. This count dropped to 86,700,000 as of January 1, 2025.
The cattle count has not been this low since it was 82,100,000 in 1951. Reflecting seasonal trends, this figure was equal to 102,000,000,
101,000,000, 98,600,000 and 95,900,000 as of July 1, 2020, 2021, 2022 and 2023, respectively. The USDA did not make this data point available
as of July 1, 2024. A significant decline in the cattle count could negatively affect the size of our addressable market.
Herd
size: Prior to 1957, there were over 20,000,000 cows in the U.S. dairy herd. Prior to 1986, there were over 10,000,000 cows in the
U.S. dairy herd. From 1998 through 2021, the size (annual average) of the U.S. dairy herd ranged from the low of 9,011,000 in 2004 to
the high of 9,448,000 in 2021. This average declined to 9,402,000 during the year ended December 31, 2022 and then declined to 9,386,000
during the year ended December 31, 2023. This average declined slightly to 9,342,000 during the year ended December 31, 2024. A significant
decline in the herd size could negatively affect the size of our addressable market.
Milk
cow price: The all-time high value (annual average) for a milk cow was $1,993 during 2015. Since then, this annual average value
steadily declined to $1,205 during 2019 before increasing to $1,300 during 2020 and to $1,363 during 2021. This price for 2022 increased
significantly to an average of $1,598, which is a 17% increase over 2021. The 2023 average price of $1,763 represents a 10% increase
over prior year. This price for 2024 increased to an average of $2,243, which is a 27% increase over 2023. A significant decline in the
milk cow price could negatively affect the size of our addressable market.
Milk
price: The dairy market, similar to many others, has been unstable for several reasons including as a result of the pandemic. The
price paid to producers for milk has been very volatile. This market volatility, and the resulting impact on our primary end users, could
negatively impact our ability to maintain and grow sales at a profitable level. The Class III milk price (an industry benchmark that
reflects the value of product used to make cheese) is an important indicator because it defines our customers’ revenue level. This
annual average milk price level (measured in dollars per hundred pounds of milk) reached its highest point (since these prices were first
reported in 1980) during 2014 at $22.34 (peaking at $24.60 in September of 2014), which price level has never been repeated. During the
year ended December 31, 2020, this average milk price was equal to $18.16, but it was extremely volatile during the year due largely
to disruption in demand related to the COVID-19 pandemic. The one-month fluctuation of 73% from a low of $12.14 in May of 2020 to $21.04
in June of 2020 set an all-time record for variability. The average price for 2021 decreased by 6% to $17.08. This price average increased
by 29% to $21.96 during the year ended December 31, 2022. The average price decreased by 22% to $17.02 during the year ended December
31, 2023. This average price increased by 11% to $18.89 during the year ended December 31, 2024. The annual fluctuations in this milk
price level are demonstrated in the following table:
Feed
Costs: The actual level of milk prices may be less important than its level relative to feed costs. One measure of this relationship
is known as the milk-to-feed price ratio, which represents the amount of feed that one pound of milk can buy. An increase in feed costs
also has a negative impact on the beef industry and therefore could have a resulting negative impact on our business and results of operations.
This ratio varies farm-to-farm based on individual operating parameters. Since this ratio reached 3.24 in 2005, it has not exceeded 3.00.
This ratio averaged 1.74 for 2021, amounting to a significant decline of 25% from the 2020 average of 2.32. This average has not been
lower since 2012. During 2022, this ratio improved by 10% to 1.91. This ratio dropped by 12% to 1.67 during the year ended December 31,
2023. This ratio increased to 2.49 during the year ended December 31, 2024, representing an increase of 49%. The following table demonstrates
the annual volatility and the low values of this ratio recently:
Volatility
of the dairy market: While the number of cows in the U.S. herd and the production of milk per cow directly influence the supply of
milk, the price for milk is also influenced by very volatile international demand for milk products. Given our focus on the dairy and
beef industries, the volatile market conditions and the resulting financial insecurities of our primary end users are risks to our ability
to maintain and grow sales at a profitable level. These factors also heighten the challenge of selling our premium-priced animal health products
(such as Tri-Shield® and Re-Tain®) into the dairy market.
Dependence
on key personnel: We are a small company with approximately73 75 employees (including 6 part-time employees).employees. As such, we rely on certain
key employees to support multiple operational functions, with limited redundancy in capacity. The loss of any of these key employees
could adversely affect our operations until a qualified replacement is hired and trained, which could be even more challenging in the
present difficult labor market. Our competitive position will be highly influenced by our ability to attract, retain and motivate key
scientific, manufacturing, managerial and sales and marketing personnel. The cost of attracting and retaining the needed additional personnel
in this current job market and inflationary environment could adversely affect our margins and profitability.
Reliance
on outside party to provide certain services under contract for us: We are exposed to additional regulatory compliance risks through
the subcontractors that we choose to work with to produce Re-Tain®, who also need to satisfy certain regulatory
requirements in order to provide us with the products and services we need. One example of this outside reliance is Norbrook, our DP
contract manufacturer. Because Norbrook notified us of its intent to terminate its supply agreement with us, we initiated an investment
of approximately $4 million during 2022 to construct and equip our own DP formulation and aseptic filling capability for Re-Tain®
in our existing DS facility. Due to the loss in gross margin during 2023 caused by the slowdown in production output necessary
to remediate product contamination events, we have decided to defer spending of approximately $2 million of these funds for the near
term. The objective of this investment is to end our reliance on an outside party to perform these services for us. Actual project costs
could exceed our current estimates. Completion of this project could be delayed due to a number of factors outside our control, including
delays in equipment fabrication, equipment delivery or facility construction. In addition, there is a risk that we fail to achieve regulatory
approval of the new facility or that such approval is delayed or requires significant additional expenditures to obtain. We are evaluating
alternatives for DP supply going forward, which include the resumption of the investment in our own in-house DP services (when prudent
based on our cash reserves) or another contract manufacturing agreement or a further extension with Norbrook. We anticipate a supply
interruption under our Controlled Launch of Re-Tain® after the DP supply provided from our contract manufacturer
is consumed and until new supply from a new contract manufacturing agreement or our own formulation and aseptic filling facility is implemented.
Competition
from others: Many of our competitors are significantly larger and more diversified in the relevant markets than we are and have substantially
greater financial, marketing, manufacturing and human resources and more extensive product development and sales/distribution capabilities
than we do, including greater ability to withstand adverse economic or market conditions and declining revenues and/or profitability.
Merck Elanco, Merck, Zoetis, Boehringer Ingelheim and Zoetis,CEVA, among other companies, sell products that compete directly with the First Defense® product line
in preventing scours in newborn calves. The scours product sold by Zoetis sells for approximately half the price of our product, although
it does not have an E. coli claim (which ours does). With Tri-Shield®, we can compete more effectively against
vaccines that are given to the mother cow (dam) to improve the quality of the colostrum that she produces for the newborn calf. Elanco,
Merck and Zoetis provide these dam vaccine products to the market.U.S. There are many companies competing in the mastitis treatment market,
most notably Boehringer Ingelheim, Merck and Zoetis. The mastitis products sold by these large companies are well established in the
market and other competitors are pricedactive lowerin thaninternational what we expect for Re-Tain®, but all of them involve traditional antibiotics and
are sold subject to a requirement to discard milk during and for a period of time after treatment (unlike our product which does not
carry an FDA-required milk discard or pre-slaughter withdrawal period).markets. There is no assurance that our products will compete successfully
in these markets. We may not be aware of other companies that compete with us or intend to compete with us in the future.
Ability to hire: Our competitive position will be highly influenced by our ability to attract and retain key scientific, manufacturing, managerial, sales and marketing personnel, to develop, produce and commercialize proprietary technologies and products. We need to obtain USDA, FDA or foreign approvals for new products to effectively promote and sell our products. We must have available properly-licensed, efficient and effective raw material and finished product manufacturing resources to continue to profitably sell our current products. We currently compete on the basis of product performance, price, distribution capability and customer support.
International
Conflicts: International conflicts, including ongoing wars in Ukraine and the Middle East,conflicts give rise to uncertainties and stress
on the global economy, which in turn can affect the demand for our products and our costs of operation. We have formerly done business in Iran. Although our ability to do so in the future is unclear, a cessation of sales to Iran would not materially affect our revenues or profitability.
Bovine
diseases: The potential for epidemics and outbreaks of bovine diseases such as Highly Pathogenic Avian Influenza (HPAI), Foot and Mouth Disease,
Bovine Tuberculosis, Brucellosis and Bovine Spongiform Encephalopathy (BSE) presents a risk to usour suppliers and to our customers. We have seen a severe
negative impact of bird flu on the U.S. poultry flock causing a significant increase in the price of eggs. We have seen a cross-over
to cows in the dairy industry. Documented cases of BSE in the United States havepolicy for the prevention of certain diseases has led to an overall tightening of regulations pertaining
to ingredients of animal origin, especially bovine. The First Defense® product line is manufactured from concentrated
bovine colostrum, which is not considered a BSE risk material. Future regulatory action to increase protection of the human food supply
could affect the First Defense® product line, although presently we do not anticipate that this will be the case.
Stock
market valuation and liquidity: Our common stock trades on The Nasdaq Capital Market (Nasdaq: ICCC). Our average daily trading volume
(which was 7,10016,939 shares per day during the 20-day period ended March 21,20, 20252026) is lower, our bid/ask stock price spread can be larger
and our share price can be more volatile than what other companies experience. Those factors could result in investors facing difficulty
selling their stock for proceeds that they may expect or desire. Our share price as of March 21,20, 20252026 was $4.91.$6.07. Most companies in the
animal health sector have market capitalization values that greatly exceed our market capitalization of approximately $44.1$54.9 million as
of March 21,20, 2025.2026. Our product sales during the year ended December 31, 20242025 were $26.5$27.6 million. This means that our market capitalization
as of March 21,20, 20252026 was equal to approximately 1.66two times our sales during the year ended December 31, 2024.2025. Before adequate gross margin
from the sale of existing and new products is achieved, our market capitalization may be heavily dependent on the perceived potential for margin expansion and revenue growth from
our product under development and may therefore be negatively affected by the related uncertainties and risks.
The
existence of the foregoing provisions and anti-takeover measures could depressadversely affect the trading price of our common stock or limit the price
that investors might be willing to pay in the future for shares of our common stock. They could also deter potential acquirers of our
Company, thereby reducing the likelihood of obtaining a premium for our common stock in an acquisition.acquisition disfavored by our Board of Directors.
Possible
dilution: We arehave accessingaccessed the capital markets and issuingissued additional common stock, from time to time, under an At-the-Market (ATM) Offering in order
to fund our operations, as described elsewhere in this Annual Report. Such issuances have a dilutive effect on our existing stockholders.stockholders and may occur again in the future.
Access
to raw materials and contract manufacturing services: Our objective is to maintain more than one source of supply for the components
used to manufacture and test our products that we obtain from third parties. However, we may experience difficulty in efficiently acquiring
essential supplies. We have significantly increased the number of farms from which we purchase colostrum for the First Defense®
product line. A significant reduction in farm capacity could make it difficult for us to produce enough inventory to meet customer
demand. The specific antibodies that we purify from colostrum for the First Defense® product line are not readily
available from other sources. We are and will be dependent on our manufacturing facilities and operations in Portland, Maine for the
production of the First Defense® product line and Re-Tain®. We will be dependent on one manufacturer
for the supply of syringes for Re-Tain®. We were dependent on a contract with Norbrook for the DP formulation and
aseptic filling for supply of our Nisin DP through 2024. Any facility used to perform these services will be subject to FDA inspection
and approval, the outcome and timing of which are not within our control. We anticipate that this FDA approval process would take at
least two years. The potential alternative options for these services are narrowed considerably because our product cannot be formulated
or filled in a facility that also processes traditional antibiotics (i.e., beta lactams).line. Any significant damage to or other disruption
in the services at anyour of these third-partyleased facilities or our ownowned facilities (including due to lack of financing, regulatory issues or
non-compliance) would adversely affect the production of inventory and result in significant added expenses and potential loss of future
sales. We anticipate a supply interruption and adverse effects on our Controlled Launch of Re-Tain® beginning during
the first quarter of 2026 (subject to confirmation of final product shelf-life disposition by the FDA). These goods represent the initial
DP production from our contract manufacturer. The extent of the interruption will be subject to the supply timeline from a new contract
manufacturing agreement or from our own formulation and aseptic filling facility for DP.
Increasing
dependence on the continuous and reliable operation of our information technology systems: We rely on information systems throughout
our company. Any disruption of these systems or significant security breaches could adversely affect our business. Although we maintain
information security policies and employ system backup measures and engage in information system redundancy planning and processes, such
policies, measures, planning and processes, as well as our current disaster recovery plan may be ineffective or inadequate to address
all eventualities. As information systems and the use of software and related applications by us, our business partners, suppliers, and
customers become more cloud-based, we become inherently more susceptible to cyberattacks. There has been an increase in global cybersecurity
vulnerabilities and threats, including more sophisticated and targeted cyber-related attacks that pose a risk to the security of our
information systems and networks and the confidentiality, availability and integrity of data and information. There are reports of increased
activity by hackers and scammers since the COVID-19 pandemic. Any such attack or breach could compromise our networks and the information
stored thereon could be accessed, publicly disclosed, lost, or stolen. While we have invested in our data and information technology
infrastructure (including working with an information security technology consultant to assess and enhance our security systems and procedures,
and periodically training our employees in such systems and procedures), there can be no assurance that these efforts will prevent a
system disruption, attack, or security breach and, as such, the risk of system disruptions and security breaches from a cyberattack remains.
We have not experienced any material adverse effect on our business or operations as a consequence of any such attack or breach but may
incur increasing costs in performing the tasks described above. Given the unpredictability of the timing, nature and scope of such disruptions
and the evolving nature of cybersecurity threats, which vary in technique and sources, if we or our business partners or suppliers were
to experience a system disruption, attack or security breach that impacts any of our critical functions, or our customers were to experience
a system disruption, attack or security breach via any of our connected products and services, we could potentially be subject to production
downtimes, operational delays or other detrimental impacts on our operations. Furthermore, any access to, public disclosure of, or other
loss of data or information, including any of our (or our customers’ or suppliers’) confidential or proprietary information
or personal data or information, as a result of an attack or security breach could result in governmental actions or private claims or
proceedings, which could damage our reputation, cause a loss of confidence in our products and services, damage our ability to develop
(and protect our rights to) our proprietary technologies and have a material adverse effect on our business, financial condition, results
of operations or prospects. While this exposure is common to all companies, larger companies with greater resources may be better able
to mitigate this risk than we can. See also PART I, ITEM 1C –— CYBERSECURITY below.
Management's Discussion & Analysis (MD&A)
New heading “Key Highlights and Developments in the Year Ended December 31, 2025”
New heading “Results of Operations for the Year Ended December 31, 2025, Compared with the Year Ended December 31, 2024”
New heading “Costs of Goods Sold”
New heading “Product Development Expenses”
New heading “Sales and Marketing Expenses”
New heading “Administrative Expenses”
New heading “Other Expenses, Net”
New heading “Income Tax Expense”
New heading “Covenants and Restrictions”
New heading “Long-lived Assets”
Removed heading “OUTLINE TO ITEM 7 — MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTES OF OPERATIONS”
Removed heading “Capital Expenditure Investments”
Removed heading “Production Contamination Events”
Removed heading “Results of Operations”
Largest changes
“Results of Operations for the Year Ended December 31, 2025, Compared with the Year Ended December 31, 2024”see in full comparison
“OUTLINE TO ITEM 7 — MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTES OF OPERATIONS”see in full comparison
“Key Highlights and Developments in the Year Ended December 31, 2025”see in full comparison
“In December of 2025, we announced a strategy pivot to focus on First Defense® and pause further investment in manufacturing Re-Tain®, to allow us to focus on the scours market opportunity. Re-Tain® was a product development initiative that the Company had pursued for some time. As a result of this decision, we recognized a $2.7 million non-cash impairment charge related to property, plant and equipment, which is included in other expenses, net. …”see in full comparison
“We periodically evaluate our long-lived assets, consisting principally of property, plant and equipment, net, operating lease ROU 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. …”see in full comparison
Full comparison: every changed paragraph (141)
We
focus on the two most critical stages of dairy productivity, those being the first 30 days of life and the first 30 days of lactation.
Our concentrated colostrum and purified Nisin technologies offer unique animal health solutions during these periods when immunity is
at its most vulnerable. Both of our product lines present growth opportunities and, in the future, may potentially be applied to other
species or potentially the human health sector, alongside the animal health sector that we currently serve. The First Defense®
production capacity expansion that we initially thought might have been completed in a year to a year and a half ended up taking
about three years to complete, but our fourth quarter sales results do demonstrate that we have increased our production capacity to,
or above, $30 million per year. The increased capacity is enabling us to address our order backlog that was equal to approximately $4.4
million and $4.7 million, as of December 31, 2024 and March 21, 2025, respectively. 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: ITEMItem 8 — FINANCIALFinancial STATEMENTSStatements ANDand SUPPLEMENTARYSupplementary DATAData of this Annual Report. 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 the Cautionary Note underRegarding Forward-Looking Statements before Part I: ITEMItem 1 — BUSINESSBusiness and Part I: ITEMItem 1A — RISKRisk FACTORSFactors 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.
Overview
ImmuCell Corporation is an animal‑health biologics company that develops, manufactures, and commercializes products designed to improve the survival, health, and long‑term performance of newborn dairy and beef calves. The Company's practical, science-based solutions help prevent calf scours, one of the most prevalent diseases in neonatal calves worldwide that accounts for 30-40% of pre-weaning mortality in many production systems. The Company’s primary product line, First Defense® utilizes hyperimmunized bovine colostrum to provide pathogen-specific antibodies and other bioactive components. First Defense® is designed to provide Immediate Immunity™ through orally delivered antibodies against the principal viral and bacterial causes of neonatal calf diarrhea (scours), including Escherichia coli (E.coli), bovine coronavirus, and bovine rotavirus. First Defense® is available in several formats—single‑dose boluses, gel syringes, and multi‑dose powder options—to fit different calf‑management needs. The Company’s manufacturing platform includes proprietary vaccine development, dairy herd hyperimmunization management, colostrum sourcing and qualification, antibody concentration and purification processes, blending, fill-finish operations, and final product testing and release. The Company markets its products through its commercial sales team, in partnership with national and regional animal‑health distributors. Its primary customers are U.S. and Canadian dairy operations, calf ranches, and beef producers, all of whom must manage calves during the critical first weeks of life—a period in which scours and other early‑life health issues can materially affect survival of the calf, farm labor inputs, growth rates, and lifetime productivity per head of cattle. Although our commercial presence outside North America is currently limited, the Company is pursuing international expansion by seeking additional regulatory approvals and building distributor partnerships. The Company has recently increased its focus on and resources for global business development as part of its long‑term growth strategy.
Key Highlights and Developments in the Year Ended December 31, 2025
We expanded our manufacturing capacity from approximately 3 million manufactured units during the year ended December 31, 2023 to 4.1 million manufactured units during the year ended December 31, 2024, and 4.6 million manufactured units during the year ended December 31, 2025. We eliminated a production contamination related backlog by the end of June 2025. We are currently identifying additional opportunities to further increase our manufacturing capacity in the future. See Item 1 — Business for further discussion about the Company's strategy for expanding production.
For the year ended December 31, 2025 compared to the year ended December 31, 2024, we grew revenue by 4.3%, and improved gross margin from 30% to 41% of product sales.
In December of 2025, we announced a strategy pivot to focus on First Defense® and pause further investment in manufacturing Re-Tain®, to allow us to focus on the scours market opportunity. Re-Tain® was a product development initiative that the Company had pursued for some time. As a result of this decision, we recognized a $2.7 million non-cash impairment charge related to property, plant and equipment, which is included in other expenses, net. Beginning in 2026, we expect that certain product development expenses formerly associated with Re-Tain® manufacturing, including depreciation expense for manufacturing facilities and equipment that we plan to repurpose for the production of First Defense®, as well as other costs including employee-related expenses, will be included in First Defense® costs of goods sold. Furthermore, depreciation expense for idle assets, which were formerly associated with Re-Tain®, that we plan to refit for the purpose of manufacturing First Defense®, may fluctuate as a result of re-evaluating the useful life of the assets.
Fiscal 2025 also saw significant realignments in company management. We hired a new President and Chief Executive Officer, created and filled a Chief Financial Officer position, and eliminated the Vice President of Operations role.
Results of Operations for the Year Ended December 31, 2025, Compared with the Year Ended December 31, 2024
Product Sales
Sales of the First Defense® product line made up 99% of our total product sales during both of the years ended December 31, 2025 and 2024. We also sell our own CMT, which is used to detect somatic cell counts in milk. Sales of CMT aggregated approximately 1% of our total product sales during the periods reported.
Product sales during the year ended December 31, 2025 were $27.6 million representing a 4%, or $1.2 million, increase over product sales of $26.5 million during the year ended December 31, 2024. The increase was primarily due to an additional $4.2 million of sales of our Tri-Shield® product as a result of higher purchasing volume from existing customers and new dairy and beef customers seeking protection for their calves. The increase was partly offset by an anticipated migration from Dual-Force® products of $2.6 million, as well as $0.4 million decrease in our First Defense Technology® product. We had an order backlog heading into 2024, which benefited product sales in the year ended December 31, 2024 as compared to the year ended December 31, 2025. We entered 2024 with $9.4 million of order backlog, reducing it to $4.4 million by December 31, 2024. By the end of June 2025, we had substantially eliminated the order backlog but still managed to post this increase in product sales for the year ended December 31, 2025. We ended 2025 with no material order backlog. While there is always uncertainty in manufacturing with biological materials, we do not anticipate recurrence of significant future order backlog at this time.
Domestic sales during the year ended December 31, 2025 increased by 6.5%, and international sales decreased by 9.6%, in comparison to the year ended December 31, 2024. The decrease in international sales was primarily driven by order timing in Canada. International sales aggregated 12% and 14% of total sales during the years ended December 31, 2025 and 2024, respectively.
Costs of Goods Sold
Costs of goods sold during the year ended December 31, 2025 were $16.2 million representing a 13%, or $2.4 million, decrease over costs of goods sold of $18.6 million during the year ended December 31, 2024. The decrease was primarily due to manufacturing volumes and efficiencies, partly offset by approximately $0.7 million of inventory write-downs on a portion of the Company's colostrum inventory.
Product Development Expenses
The majority of our product development expenses pertain to the development of Re-Tain®, our purified Nisin treatment for subclinical mastitis in lactating cows. During the year ended December 31, 2025, product development expenses decreased by 22%, or $0.9 million, to $3.0 million in comparison to $3.9 million during the year ended December 31, 2024. This decrease was driven by a reduction in product development expenses related to Re-Tain® as part of an aggressive idle of product development expenses as we awaited what we believed would be the fifth and final Technical Section Complete Letter from the FDA. As discussed under "Key Highlights and Developments in the Year Ended December 31, 2025" above, we made the decision to no longer pursue the fifth Technical Section Complete Letter from the FDA during December 2025.
Sales and Marketing Expenses
During the year ended December 31, 2025, sales and marketing expenses increased by 3%, or $0.1 million, to $3.6 million in comparison to $3.5 million during the year ended December 31, 2024. This increase was primarily due to $0.4 million higher marketing and consulting as a result of increased commercial activity and inflation. Exiting the backorder situation led us to increase commercial activity generally during 2025. This increase was almost fully offset by a $0.4 million decrease in salaries and wages as a result of open positions during the year ended December 31, 2025. We are planning investments to support increased sales capacity in the year ended December 31, 2026 in both the U.S. and international markets. Sales and marketing expenses amounted to approximately 13% of product sales in both of the years ended December 31, 2025 and 2024.
Administrative Expenses
During the year ended December 31, 2025, administrative expenses increased by 44%, or $1.0 million, to $3.2 million in comparison to $2.2 million during the year ended December 31, 2024. The increase was primarily due to $0.8 million of costs associated with executive officer changes and additions. On April 7, 2025, we added a chief financial officer to the administrative team. On November 1, 2025, we hired a new President and CEO because of the pending retirement of our former President and CEO. In connection with this hire, we incurred certain one-time expenses, including recruiting fees, a signing bonus and overlapping transitional wages for two months with our former President and CEO. These one-time items contributed to $0.3 million of the $0.8 million costs associated with the executive officer changes and additions. Also contributing to the administrative expense increase was an additional $0.1 million of information technology costs as compared to the prior year. This increasing level of investment in executive staff and infrastructure is intended to support our anticipated growth. In 2026, we anticipate higher administrative expenses associated with the full-year impact of increased headcount and higher wages, much of which is non-cash share-based compensation and other incentive accruals.
Other Expenses, Net
During the year ended December 31, 2025, other expenses, net, increased by 429%, or $2.2 million, to $2.7 million in comparison to $0.5 million during the year ended December 31, 2024. The increase was primarily due a $2.7 million non-cash impairment charge related to property, plant and equipment, formally related to the Re-Tain® product line. Partly offsetting the increase was insurance recoveries related to inventory damages occurring in prior periods of $0.4 million.
Income Tax Expense
During both of the years ended December 31, 2025 and 2024, we recorded insignificant income tax expense.
We have substantial net operating loss carryforwards that will largely offset future income tax liabilities. As of December 31, 2025, our federal net operating loss carryforward was $17.5 million. As of December 31, 2025, our state net operating loss carryforward was $7.7 million.
The Tax Cuts and Jobs Act of 2017 reduced the U.S. corporate income tax rate to 21% and modified rules governing net operating loss carryforwards and carrybacks, among other changes. On July 4, 2025, the One Big Beautiful Bill Act was enacted, which permanently extends and modifies certain provisions of the Tax Cuts and Jobs Act. Key provisions include 100% bonus depreciation for qualified property, immediate expensing of domestic research and experimental expenditures under IRC Section 174A, and restoration of an Earnings Before Interest Taxes Depreciation and Amortization (EBITDA)-based calculation for the business interest expense limitation under IRC Section 163(j). The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The legislation did not have a material impact on our effective tax rate for the year ended December 31, 2025 or our financial statements. We continue to evaluate the impact of these provisions on our tax position, including their effect on our deferred tax assets and related valuation allowance.
Our effective income tax rate differs from the statutory U.S. corporate tax rate primarily because we continue to provide a full valuation allowance against our deferred tax assets. While this valuation allowance remains in place, we are not recognizing the benefit of our tax losses. We evaluate the realizability of our deferred tax assets at each reporting date, considering all available positive and negative evidence, and will reduce the valuation allowance to the extent it becomes more likely than not that some or all of the deferred tax assets will be realized.
OUTLINE
TO ITEM 7 — MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTES OF OPERATIONS
Our sources of liquidity and capital resources are cash flows from operations, proceeds from our sale of common stock under our At-The-Market Agreement with Craig-Hallum Capital Group LLC (ATM Agreement), and borrowings available under our bank line of credit.
In April of 2024, we entered into our ATM Agreement, which allows us to offer and sell up to $11 million of shares of our common stock. Proceeds, net of upfront legal, accounting and other fees, less sales commissions during the year ended December 31, 2025 and December 31, 2024 were $0.3 million and $4.4 million, respectively. Particularly in 2024, this provided a financial bridge to fund our operations during a backlog situation that lasted from 2022 to mid-2025. As of December 31, 2025, we have the capacity to sell $6 million of shares under the ATM Agreement but no pending plan to issue additional shares under that arrangement.
We
are fortunate to be experiencing strong customer demand for the First
Defense® product line, but the significant investments in facilities, equipment and staffing
necessary to double our production capacity have been challenging. Despite delays in the installation of certain equipment, we completed
these capacity-expanding investments around the end of 2022. In late 2022, we began experiencing production contamination events that
became more frequent during 2023 and continued through April of 2024. With newly implemented controls in place, we now believe that we
have successfully remediated the issues underlying these contamination events. Our next challenge is to resume our past production yields
and achieve our gross margin goals in excess of 40%. By both remediating the contamination events and optimizing the operation of the
new equipment installed to increase production output, we began to improve process yields beginning during the fourth quarter of 2024,
as demonstrated by the 37% gross margin we achieved during the fourth quarter of 2024. We did not find one “smoking gun”
as the root cause to the contamination and yield losses. We think the solution is more about optimizing and controlling critical process
parameters and multiple production inputs and process steps.
Concurrently,
we are reducing product development expenses as we await approval of Re-Tain®
by the FDA. After an investment of about 25 years and approximately $50 million in the development
of this technology, we are committed to seeing this product through to regulatory approval and our previously disclosed limited distribution,
controlled launch strategy (Controlled Launch). At the same time, we are also in the very early stages of exploring potential strategic
options that could offset some of our product development expenses and enhance a mass-market launch of Re-Tain®.
In order to help fund these gross margin losses and production capacity expansions, we raised some new debt during 2023 and equity during
2024.
Net cash provided by operating activities was
$358,000 during the year ended December 31, 2024 in contrast to net cash (used for) operating activities of ($4.7 million) during the
year ended December 31, 2023. This $5 million improvement in net cash provided by operating activities between the years was largely due
to a $3.6 million decrease in the net loss and a $2.5 million swing from cash used for inventory during 2023 to cash generated by reductions
in inventory during 2024, which sources of cash were net against $1.2 million more cash being used for accounts receivable during 2024
than during 2023. Our inventory balance decreased by $699,000 to $7.1 million as of December 31, 2024 from $7.8 million as of December
31, 2023. Interest expense (excluding amortization of debt issuance and debt discount costs) was $526,000 and $453,000 during the years
ended December 31, 2024 and 2023, respectively. Our debt bears interest at fixed rates, which on a blended basis amounts to 4.51% per
annum. We anticipate that interest expense (excluding amortization of debt issuance and debt discount costs) will be $452,000 and $322,000
during the years ending December 31, 2025 and 2026, respectively. Our total non-cash depreciation, amortization and stock-based compensation
expense was approximately $3.1 million during both of the years ended December 31, 2024 and 2023. We anticipate that depreciation expense
(largely pertaining to Re-Tain®), while not affecting our cash flows from operations, will be a significant factor in creating
annual net operating losses until and unless product sales increase sufficiently to offset these non-cash expenses. Further, as we fill
the order backlog for First Defense®, we will require additional capital to fund an anticipated increase in inventory
levels.
Net
cash used for investing activities was ($461,000) during the year ended December 31, 2024 versus ($1.9 million) during the prior year
consisting primarily of cash spent to fund the purchase of property, plant and equipment. To conserve cash at this time, we have deferred
all large dollar capital expenditure projects.
Net
cash provided by financing activities was $2.9 million during the year ended December 31, 2024 versus of $1.8 million during the prior
year. During the third quarter of 2023, we received $3 million in new debt proceeds. We had aggregate debt outstanding (net of debt issuance
and debt discount costs) of approximately $10.5$9.1 million and $12$10.5 million as of December 31, 20242025 and 2023,2024, respectively. DebtRecurring debt principal
repayments (excluding the line of credit) aggregated $1.5 million andduring $1.2 million duringboth the years ended December 31, 20242025 and 2023,
respectively.2024. We anticipate that recurring debt principal repayments will aggregate approximately $1.5$1.6 million and $3.3$1.2 million during the years
ending December 31, 20252026 and 2026,2027, respectively. During the firstthird quarter of 2024,2025, the availability of our $1$1.0 million line of credit,
which bears interest at the National Prime Rate per annum, was extended until September 11, 2025.2026. No draw on our line of credit was outstanding
as of December 31, 20242025, or December 31, 2023.2024. See Part II: Item 8 — Financial Statements and Supplementary Data: Note 99, to"Bank the accompanying audited financial statementsDebt" for more information about
our bank debt. During the second quarter of 2024, we entered into an At-The-Market (ATM) Agreement with Craig-Hallum Capital Group LLC,
under which we may offer and sell up to $11 million of shares of our common stock. As of December 31, 2024, we had sold 1,228,227 shares
under this ATM Offering conducted pursuant to the ATM Agreement. Net proceeds through December 31, 2024 (net of approximately $152,000
in upfront legal, accounting and other fees and approximately $140,000 in sales commissions) were approximately $4.4 million. The ATM
Agreement gives our board the flexibility to evaluate the potential uses of the proceeds while considering the cost of dilution in real
time. This funding has provided a very productive financial bridge for us to fund our operations, while we work to improve our gross
margin and reduce product development expenses. While the capital raised is not enough to fund larger capital expenditure investments,
such as further increasing First Defense® production capacity or building our own facility for the aseptic filling
services for Re-Tain®, it has allowed us to release funding for certain smaller and necessary capital expenditures.
Interest expense (excluding amortization of debt issuance and debt discount costs) was approximately $439,000 and $526,000 during the years ended December 31, 2025, and 2024, respectively. Our debt bears interest at fixed rates, which on a blended basis amounts to 4.31% per annum. We anticipate that interest expense (excluding amortization of debt issuance and debt discount costs) will be $367,000 and $297,000 during the years ending December 31, 2026 and 2027, respectively.
The table below summarizes the changes in selected key accounts:
(1) There were 801,760 and 664,000 shares of common stock reserved for stock option issuance that were outstanding as of December 31, 2025 and 2024, respectively.
We continuously assess sources and uses of cash for our business. In addition to normal working capital requirements, we anticipate that our short-term and long-term cash requirements consist primarily of general corporate needs, capital expenditures, debt requirements, amounts due under operating lease agreements, and other commitments. Based on our current best estimates, we believe that our existing cash and cash equivalents, together with cash flows from operations and our bank line of credit, will be sufficient to meet our currently planned working capital, capital expenditure, and debt requirements and to finance our ongoing business operations for at least the next 12 months and the foreseeable future.
Cash Flows
Net cash provided by operating activities increased $2.1 million during the year ended December 31, 2025 as compared to the year ended December 31, 2024. This increase was primarily due to $1.9 million less cash being used for accounts receivable and a $1.1 million decrease in net loss, which included a $2.7 million increase in non-cash adjustments. These factors were partly offset by a $2.9 million increase in cash used for inventory as a result of our efforts to replenish after periods of high backlog.
Net cash used for investing activities increased $0.8 million during the year ended December 31, 2025, as compared to the year ended December 31, 2024, primarily due to cash spent to fund the purchase of property, plant and equipment primarily for manufacturing. Cash used on property, plant and equipment represents more normalized spend levels than 2024, when there was a significant effort to conserve cash.
Net cash used for financing activities increased $4.0 million during the year ended December 31, 2025 as compared to the year ended December 31, 2024. The increase in net cash used was primarily due to an approximate reduction of $4.3 million in proceeds from sales of common stock under the ATM Agreement, partly offset by lower payments of equity offering costs. During the year ended December 31, 2025, we refinanced a portion of our bank debt, resulting in borrowings and repayments in approximately the same amount. During the year ended December 31, 2025, we also made standard mandatory repayments on our bank debt of approximately $1.5 million, which were generally consistent with the same payments in the prior year.
Covenants and Restrictions
Our debt with Maine Community Bank is subject to certain financial covenants. We are required to meet a minimum debt service coverage (DSC) ratio of 1.35. Our actual DSC ratios were 2.65 and 0.73 for the years ended December 31, 2025, and 2024, respectively. In the second, third and fourth quarters of 2024, the bank preemptively waived the DSC waiver. There is no assurance that we will be able to achieve the required DSC ratio going forward. If we are unable to do so or reach a favorable agreement with our lenders regarding that requirement (including an amendment to or waiver of such requirement), we would be in violation of that covenant, which could result in unfavorable amendments to the terms of our bank debt (including a possible bank requirement to prepay our debt) or have other adverse impacts on our business and results of operations.
We
project (based on our best estimates) that our existing 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 the next 12 months (the period of time required to be addressed for such purposes
by accounting disclosure standards). The table below summarizes the changes in selected key accounts (in thousands, except for percentages):
Capital
Expenditure Investments
During
the three-year period ended December 31, 2016, we invested the aggregate of $4.2 million to construct a 7,100 square foot facility addition
at 56 Evergreen Drive (Building 56) and related equipment (primarily Freeze-Dryer #2) and cold storage capacity 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. When we describe the production capacity for the First
Defense® product line in this Annual Report, it should be noted that the actual value of this capacity varies based
on biological and process yields, product format mix, selling price and other factors. During the first quarter of 2016, we completed
this investment, which also included the construction and equipping of a pilot plant for small-scale DS production for Re-Tain®
within Building 56. After construction of the DS production facility for Re-Tain® at 33 Caddie
Lane (Building 33) was completed, this space was converted for use in the production of the gel tube formats of the First Defense®
product line. After renovations of our leased facility at 175 Industrial Way (Building 175A) were completed during the
second quarter of 2020, this space was converted to double our liquid processing capacity.
During
the four-year period ended December 31, 2018, we invested the aggregate of $21.6 million to construct a DS production facility for Re-Tain®
at Building 33. During the fourth quarter of 2017, we completed construction of the DS 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 DS 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 at 14 Wedge Way (Building 14), which will
be used for packing, shipping and cold storage of Re-Tain® and other warehousing needs.
During
2018, it became clear that demand for Tri-Shield First Defense® was outpacing production. In response to this increasing
demand, we began a series of investments during 2019 to increase our production capacity for the First Defense®
product line from approximately $16.5 million to approximately $30 million or more per year (with an option to increase further to approximately
$40 million in the future). The additional investment in First Defense® should
allow us to fulfill the current backlog of First Defense® orders
and materially reduce the risk of another order backlog. Operating at very close to 100% of available capacity is not efficient or sustainable.
Our objective is to be in position to operate without significant contaminations at the capacity level we choose to cover sales with
adequate buffer stock, which would allow more time for necessary preventative maintenance. We also need to meet or exceed our production
yield assumptions to succeed. Our production process is complex and difficult to scale-up quickly. We remain deeply committed to meeting
demand for First Defense® and overcoming the current short supply that we have been experiencing.
The
primary purpose of the additional investments in Re-Tain® is to bring the formulation and aseptic filling capabilities
for Re-Tain® DP into available space in our DS facility in order to lessen or eliminate our reliance on third-party
DP manufacturing services as well as the build out of warehouse space at Building 14 for packing and shipping facilities for Re-Tain®.
We began initial installation of the filling equipment during the first quarter of 2022 and then paused this installation work due to
the lack of adequate cash.
The
amount and timing of these additional investments in First Defense®
and Re-Tain® that were initiated beginning
in 2019 are detailed in the following table (in thousands):
The
first phase of the additional investments in First Defense® beginning
in 2019 included significant renovations to a 14,300 square foot leased facility at Building 175A, some facility
modifications at Building 56 and the necessary production equipment (including Freeze-Dryer #3) to increase our liquid processing
capacity by 100% and our freeze-drying capacity by 50%. This resulted in increasing 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. Renovations of Building
175A to enable this expansion were completed during the second quarter of 2020. By moving our powder and gel filling and assembly
operations from Building 56 into this new space, we created space at Building 56 for the installation of the expanded freeze-drying
capacity. The new facilities are built to contemporary cGMP standards with efficient material and people flows. A site license approval
for this new facility 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 Building 56 to Building 175A, which created the space necessary to double our liquid
processing capacity at Building 56. We obtained site license approval of the expanded freeze-drying capacity (Freeze-Dryer #3)
at Building 56 from the USDA during the third quarter of 2021, and we obtained site license approval of the expanded liquid processing
capacity at Building 56 from the USDA during the third quarter of 2022. This investment also included equipment and vehicle purchases
necessary to expand and improve our colostrum collection capabilities and logistics.
The
second phase of the additional investments in First Defense® included the installation of Freeze-Dryer #4 to further
increase the estimated annual production capacity of the First Defense® product line (in terms of annual sales
dollars) by an additional 33% from approximately $23 million to approximately $30 million or more. As of July of 2022, we had completed
almost all of the facility expansion work and new equipment installations needed to increase our production capacity to approximately
$30 million or more per year. However, the most critical piece of new equipment (being Freeze-Dryer #4) was delivered six months late
by the fabricator. Regardless, by the end of 2022, we had Freeze-Dryer #4 installed and approved for use by the USDA. At the same time,
Freeze-Dryer #2 stopped operating requiring a six-month repair and netting us back to three operating freeze dryers during the first
half of 2023. As of July of 2023, we were back to four operating freeze dryers. This investment also included equipment and facility
modifications to scale-up and upgrade our vaccine manufacturing capacity and improve our quality laboratories at Building 56 as
well as the installation of new equipment to increase the throughput of our gel filling operations at Building 175A.
The
third phase of the additional investments in First Defense® involved the construction of an additional 15,400 square
feet of space adjacent to and connected to Building 175A at 175 Industrial Way (Building 175B) and new equipment to further
increase our estimated annual First Defense® production capacity from approximately $30 million to approximately
$40 million with options for further expansion. Given the long lead time required for investments like this, we initiated this project
by entering into a lease amendment during the third quarter of 2022 covering a to-be-constructed building shell for approximately $250,000
per year. Construction of the building shell by our landlord was substantially complete as of April 1, 2023, and rent payments commenced
as of August 1, 2023. We made this lease commitment because of the unique proximity of the land adjacent to our currently leased space
and the high level of demand for properties of this type in the Portland market. We did not want to risk losing this opportunity to others.
The anticipated benefits to us from this new lease include: i) space for the potential to install Freeze-Dryers #5, #6, #7 and #8 if
justified by market demand in the future, ii) improved space and quality for our powder milling operations by separating our upstream
processes (liquid processing) at Building 56 from our clean downstream processes (milling, formulation, filling and packaging)
at Building 175A and iii) much needed additional warehouse space. We have been running our equipment and staff close to 100% of
capacity in order to fill the backlog of orders. One of our objectives is to create a more sustainable production schedule. Freeze-Dryer
#5 is the key piece of equipment required to allow us to increase our estimated annual production capacity to above $30 million. Based
on past experience, we are planning for approximately 18 months of lead time for fabrication, installation, qualification and implementation
of Freeze-Dryer #5. However, due to the loss in gross margin during 2023 caused by the slowdown in production output necessary to remediate
the product contamination events discussed below, we have decided to defer most of this investment, for the time being. Instead, we initiated
the initial steps on a portion of this project with a reduced budget of approximately $700,000 at Building 175B during the third
quarter of 2023. This work was completed during the first quarter of 2024, which provided additional warehousing space and allowed us
to move all shipping and receiving functions out of Building 56 to create more space for liquid processing at Building 56.
Production
Contamination Events
As
our increased production capacity was coming online around the end of the third quarter of 2022, our standard in-process quality control
testing detected a product contamination event likely related to our incoming raw material (which is sourced from many different cows
at many different farms). We took immediate steps to address the contamination, and production ran without issue during the balance of
the fourth quarter of 2022. Subsequently, as we began to operate at a higher level of capacity at the beginning of 2023, we were forced
to slow down production again to remediate a second contamination event also likely related to our incoming raw material. We then ran
for approximately six months without contamination and then experienced a smaller third contamination event in September of 2023 impacting
two lots of Work-in-Progress inventory, likely related to process changes implemented to run our increased level of liquid processing.
Although all of the incoming material utilized in this production phase had passed quality control testing, the product failed the quality
control tests later in the production process. We experienced a fourth contamination event impacting three lots of Work-in-Process inventory
during the first three and a half months of 2024. New remediation steps implemented in response to this fourth event during the second
half of April of 2024 appear to have been successful so far because we have run without contamination since then. Throughout these contamination
events, all product that was sold to market met all in-process and final release testing to meet USDA-required quality standards.
As
we look back at these production contamination events, we believe that the root cause of the initial contaminations was associated with
rapid growth in our purchases from the farms where we acquire our raw material. Having largely remediated that problem, we then experienced
additional contaminations that we believe were largely caused by rapidly increasing our production capacity. Our proprietary production
process does allow us to create an effective product out of a non-aseptic starting raw material. This requires a careful monitoring,
however, of the tradeoff between the benefit of adding more heat for longer periods of time to reduce bacterial load against the alternative
benefit of less heat for shorter periods of time to preserve more antibody content. Although using more heat could potentially reduce
bacterial load, our yield is higher when we use less heat. We know that putting our Work-in-Process inventory through freeze/thaw cycles
is not beneficial to yield and increases the risk of contamination. One effective improvement we have implemented, where appropriate,
is to lengthen the time of a heat treatment step instead of running two shorter heat treatment steps separated by a freeze/thaw. As we
continue to optimize these critical process parameters, we believe we can significantly reduce the risk of further contaminations and
improve our gross margin.
Although
these types of losses are expected to happen from time to time in the production of a biological product such as ours, we believe that
the sudden and large contamination events were related in several different ways to our efforts to increase production output. We also
believe we have mitigated the risk of large-scale reoccurrence of such losses by implementing various new quality control steps and manufacturing
process and facility improvements. To meet our goals, we must run without significant equipment failures or contamination losses, and
we must continue to improve our production yields.
What changed in the latest 10-Q
Risk Factors
Largest changes
“Production capacity constraints: The inability to meet market demand for our products is a risk to our business. Our plans call for increases of our production capacity through yield improvements, redeploying assets previously slated for production of Re-Tain® and investing approximately $3.5 million in incremental freeze drying capacity and approximately $4.5 million in colostrum processing capacity over the next 12 to 18 months. …”see in full comparison
“Colostrum collection: There is a risk that the farms that participate in our vaccination and colostrum collection process no longer wish to continue supplying us with colostrum, due to the need to use all or part of the colostrum for their own calves, or concerns with the increasing cost of colostrum-replacement products, or higher prices offered by other companies that use colostrum to develop human or animal health products. …”see in full comparison
Full comparison: every changed paragraph (3)
ThereExcept as set forth below, there have been no material changes tofrom the risk factors identified in our Annual Report on Form 10-K for the year ended December 31, 2025, in response to Item 1A., “Risk Factors,” of Part I of the Annual Report.
Production capacity constraints: The inability to meet market demand for our products is a risk to our business. Our plans call for increases of our production capacity through yield improvements, redeploying assets previously slated for production of Re-Tain® and investing approximately $3.5 million in incremental freeze drying capacity and approximately $4.5 million in colostrum processing capacity over the next 12 to 18 months. Expanding manufacturing capacity involves practical and technical risks affecting efficiency of production including contamination and yields, and risks of not being able to access sufficient high-quality colostrum or other raw materials. There is a risk of cost overruns in our production expansion project, and a risk that we will not be able to achieve our production capacity growth objectives on a timely basis, resulting in a shortfall in supply to the market. A backlog of orders presents a risk that we could lose customers that are not easily regained. Our long-term capital plan to continue to expand the First Defense® product line requires ongoing review of equipment capacity and utilization and assessment of costs, functional obsolescence and reliability of equipment. This review and assessment could identify a need to fund unexpected equipment maintenance or replacement costs.
Colostrum collection: There is a risk that the farms that participate in our vaccination and colostrum collection process no longer wish to continue supplying us with colostrum, due to the need to use all or part of the colostrum for their own calves, or concerns with the increasing cost of colostrum-replacement products, or higher prices offered by other companies that use colostrum to develop human or animal health products. There is a risk that our supply farms, which are almost entirely located in one state, are subject to a disease outbreak that inhibits their ability to supply the colostrum. There is a risk that the quality of the colostrum collected will not be suitable for our production requirements.
Management's Discussion & Analysis (MD&A)
New heading “First Defense® Manufacturing Expansion”
New heading “Administrative Expenses”
New heading “Product Development Expenses”
New heading “Other Operating Income”
New heading “Other Expenses, Net”
New heading “Income Tax Expense”
New heading “Results of Operations for the Six Months Ended June 30, 2026, Compared with the Six Months Ended June 30, 2025”
New heading “Costs of Goods Sold”
New heading “Other Operating Income”
New heading “Sales and Marketing Expenses”
Largest changes
“Results of Operations for the Six Months Ended June 30, 2026, Compared with the Six Months Ended June 30, 2025”see in full comparison
Full comparison: every changed paragraph (52)
ImmuCell Corporation, founded in 1982 and aan SEC-registered public company since 1987, is an animal health biologics company focused on the development, manufacture, and commercialization of products intended to improve the survivability, health, and long-term performance of neonatal dairy and beef calves.
In connection with the idle status of certain property, plant and equipment, net,net (related to the repurposing of certain equipment previously utilized in the manufacturing of Re-Tain®), during December 2025, we reassessed prior estimates of the useful lives of that manufacturing equipment. Because the equipment had seen such limited use during the period since installation, we increased the estimated remaining useful lives on certain equipment by a weighted average of five years effective January 1, 2026.years. The effect of this change in estimateestimate, effective January 1, 2026, for the three months ended MarchJune 31,30, 2026 was a $0.1 million decrease to depreciation expense included in costs of goods sold, and an increase in operating income and net income of $0.1 million, or $0.01 per both basic and diluted share. The effect of this change in estimate for the six months ended June 30, 2026 was a $0.2 million decrease to depreciation expense included in costs of goods sold, and an increase in operating income and net income of $0.2 million, or $0.02 per both basic and diluted share.
Sales of the First Defense® product line are seasonal, with higher sales expected during the first quarter of the calendar year, largely driven by the beef calving season, which runs primarily from January to April, unlike the dairy industry where operations generally calve year-round. Warm and dry weather conditions may reduce the producers' perceived need for disease prevention products such as the First Defense® product line. However, heat stress on calves caused by extremely hot summer weather and cold stress during the winter months can increase the incidence of scours and the need for our products.
First Defense® Manufacturing Expansion
In late December 2025 and early January 2026, we announced our plan to convert the former Re-Tain® facilities and most of the related equipment for increased production of our First Defense® product line. In June 2026, our Board of Directors authorized a manufacturing capacity expansion program to execute on that strategy.
The first phase, which we have initiated to stay ahead of current and future demand growth, expands drying capacity by renovating the former Re-Tain® facility and adding a new freeze dryer with greater capacity and reliability than our current freeze-drying equipment. This phase is expected to take approximately 12 months and cost approximately $3.5 million.
In a second phase, we plan to repurpose Re-Tain® equipment and add additional equipment and automation to expand our First Defense® colostrum liquid processing capacity. The second phase will involve additional investments, including for detailed engineering work to develop an efficient and scalable process. This phase is expected to take an additional six months and cost approximately $4.5 million.
The goal of these capacity expansion investments is to further strengthen our ability to reliably manufacture First Defense® products to meet expected customer demand.
Results of Operations for the Three Months Ended MarchJune 31,30, 2026, Compared with the Three Months Ended MarchJune 31,30, 2025
NM - Not meaningful
Sales of the First Defense® product line made up 99.5%approximately 99% of our total sales during the three months ended MarchJune 31,30, 2026 and 2025. We also sell our own CMT, which is used to detect somatic cell counts in milk. Sales of CMT aggregated approximately 0.5%1% of our total product sales during the periods reported.
Product sales during the three months ended MarchJune 31,30, 2026 were $10.4$7.2 million representing a 28.4%,11.5%, or $2.3$0.7 million, increase over product sales of $8.1$6.4 million during the three months ended MarchJune 31,30, 2025. The increase was primarily due to higher sales volumes for all product categories of Tri-Shieldthe First Defense® product line, including portfolio expansion, and Dual Force® combined with year-over-year product price increases across most product lines.increases.
Domestic sales during the three months ended MarchJune 31,30, 2026 increased by 35.7%27.7% (to $9.7$6.2 million), and international sales decreased by 30.2%38.9% (to $0.6$1.0 million), in comparison to the three months ended MarchJune 31,30, 2025. International sales aggregated 6.0%13.4% and 11.1%24.4% of total sales during the three months ended MarchJune 31,30, 2026 and 2025, respectively.
Costs of goods sold during the three months ended MarchJune 31,30, 2026 were $5.7$4.7 million representing a 20.9%,30.9%, or $1.0$1.1 million, increase over costs of goods sold of $4.7 million during the three months ended MarchJune 31,30, 2025. The increase was primarily due to higher sales of First Defense® combined with a shift of $0.3 million of costs associated with the former Re-Tain® manufacturing facility from product development expense to costs of goods sold.sold, Costalong with $0.2 million in manufacturing inefficiencies and $0.2 million of increased raw material costs during the three months ended June 30, 2026. Costs of goods sold increased at a rate lowerhigher than sales due to price increases effective January 1, 2026 and manufacturing efficiencies obtained during the period, partially offset by the shift of depreciation and building related expenses related to our 33 Caddie facility (formerly associated with Re-Tain®) from product development expense as a result of the Company's December 2025 decision to cease its focusefforts on obtaining FDA approval of Re-Tain® and instead refit the facility for use in producing First Defense® products.products, and manufacturing inefficiencies and increased raw material costs in the three months ending June 30, 2026, partially offset by price increases effective January 1, 2026.
Administrative Expenses
During the three months ended June 30, 2026, administrative expenses increased by 76.6%, or $0.6 million, to $1.3 million in comparison to $0.7 million during the three months ended June 30, 2025. The increase was primarily due to a $0.3 million increase in executive compensation (including share-based compensation), coupled with $0.1 million in higher professional services fees.
.
During the three months ended MarchJune 31,30, 2026, sales and marketing expenses increased by 43.9%,59.6%, or $0.4 million, to $1.2$1.1 million in comparison to $0.9$0.7 million during the three months ended MarchJune 31,30, 2025. This increase was primarily due to expanded commercial efforts in First Defense® leading to higher wages, including share-based compensation,compensation and expenses associated with new and backfilled sales positions, coupled with increased promotional and tradeshow related expenses.positions. In the three months ended MarchJune 31,30, 2025, we restricted commercial spending due to tight product supply; however, this tight supply was alleviated in the summer of 2025.
Product Development Expenses
During the three months ended June 30, 2026, product development expenses decreased by 85.6%, or $0.7 million, to $0.1 million in comparison to $0.8 million during the three months ended June 30, 2025. This decrease was driven by the $0.3 million shift to costs of goods sold of depreciation and building related expenses related to our 33 Caddie facility (formerly associated with Re-Tain®) as part of our recently announced strategy to utilize the facility for the production of First Defense® as a result of our December 2025 decision to cease our efforts on obtaining FDA approval of Re-Tain® and instead refit the facility for use in producing First Defense® products, coupled with a $0.2 million reduction of wages and lab supplies associated with Re-Tain® product development and $0.1 million lower licenses and fees related expense.
Other Operating Income
During the three months ended June 30, 2026, the Company recorded a $2.0 million settlement with a former contract manufacturer that compensated the Company for operating costs incurred in product development and contract performance related to the development of the Company’s Re-Tain® product. The settlement resolved claims for operating costs the Company incurred in developing the product. The settlement agreement fully released the parties with no further material obligations. There are no remaining material contingent amounts related to this settlement.
Other Expenses, Net
During both the three months ended June 30, 2026 and 2025, other expenses, net was insignificant.
Income Tax Expense
During the three months ended June 30, 2026, we recorded $45,950 of income tax expense as compared to $1,904 during the three months ended June 30, 2025. We anticipate having some amount of tax liability for profits we may realize moving forward, as certain NOLs carried forward no longer 100% offset taxable income, but 80% instead.
Results of Operations for the Six Months Ended June 30, 2026, Compared with the Six Months Ended June 30, 2025
NM - Not meaningful
Product Sales
Sales of the First Defense® product line made up more than 99% of our total sales during the six months ended June 30, 2026 and 2025. We also sell our own CMT, which is used to detect somatic cell counts in milk. Sales of CMT aggregated approximately 0.5% of our total product sales during the periods reported.
Product sales during the six months ended June 30, 2026 were $17.5 million representing a 20.9%, or $3.0 million, increase over product sales of $14.5 million during the six months ended June 30, 2025. The increase was primarily due to higher sales volumes for all product categories of the First Defense® product line, including portfolio expansion, and product price increases.
Domestic sales during the six months ended June 30, 2026 increased by 32.5% (to $16.0 million), and international sales decreased by 35.7% (to $1.6 million), in comparison to the six months ended June 30, 2025. International sales aggregated 9.0% and 17.0% of total sales during the six months ended June 30, 2026 and 2025, respectively.
Costs of Goods Sold
Costs of goods sold during the six months ended June 30, 2026 were $10.4 million representing a 25.3%, or $2.1 million, increase over costs of goods sold of $8.3 million during the six months ended June 30, 2025. The increase was primarily due to higher sales of First Defense® combined with a shift of $0.6 million of costs associated with the former Re-Tain® manufacturing facility from product development expense to costs of goods sold, and $0.4 million of increased raw material costs. Costs of goods sold increased at a rate higher than sales due to the shift of depreciation and building related expenses related to our 33 Caddie facility (formerly associated with Re-Tain®) from product development expense as a result of the Company's December 2025 decision to cease its efforts on obtaining FDA approval of Re-Tain® and instead refit the facility for use in producing First Defense® products, and higher raw material costs, partially offset by price increases effective January 1, 2026.
During the threesix months ended MarchJune 31,30, 2026, administrative expenses increased by 82.7%,79.4%, or $0.5$1.1 million, to $1.1$2.4 million in comparison to $0.6$1.3 million during the threesix months ended MarchJune 31,30, 2025. The increase was primarily due to a $0.4$0.7 million increase in executive compensation (including share-based compensation)., coupled with $0.2 million additional legal and professional service fees.
Other Operating Income
During the six months ended June 30, 2026, the Company recorded a $2.0 million settlement with a former contract manufacturer that compensated the Company for operating costs incurred in product development and contract performance related to the development of the Company’s Re-Tain® product. The settlement resolved claims for operating costs the Company incurred in developing the product. The settlement agreement fully released the parties with no further material obligations. There are no remaining material contingent amounts related to this settlement.
Sales and Marketing Expenses
During the six months ended June 30, 2026, sales and marketing expenses increased by 50.9%, or $0.8 million, to $2.3 million in comparison to $1.6 million during the six months ended June 30, 2025. This increase was primarily due to expanded commercial efforts in First Defense® leading to $0.6 million in higher compensation and expenses associated with new and backfilled sales positions, coupled with $0.1 million in increased promotional and tradeshow related expenses. In the six months ended June 30, 2025, we restricted commercial spending due to tight product supply; however, this tight supply was alleviated in the summer of 2025.
During the threesix months ended MarchJune 31,30, 2026, product development expenses decreased by 58.0%,72.5%, or $0.4$1.2 million, to $0.3$0.4 million in comparison to $0.8$1.6 million during the threesix months ended MarchJune 31,30, 2025. This decrease was driven by the $0.3$0.6 million shift to costs of goods sold of depreciation and building related expenses related to our 33 Caddie facility (formerly associated with Re-Tain®) as part of our recently announced strategy to utilize the facility for the production of First Defense® as a result of the Company'sour December 2025 decision to cease itsour focusefforts on obtaining FDA approval of Re-Tain® and instead refit the facility for use in producing First Defense® products, coupled with a $0.4 million reduction of wages and lab supplies associated with Re-Tain® product development.development and $0.1 million lower licenses and fees.
Other (ExpenseExpenses) Income, Net
During the threesix months ended MarchJune 31,30, 2026, other expense,(expenses) income, net was $15,187($0.1) million in comparison to $0.3 million of other (expenses) income, net during the threesix months ended MarchJune 31,30, 2025. The year-over-year netexpenses shiftincrease of 104.6%126.2% or $0.3 million was primarily due to a one-time insurance settlement of $0.4 millionrecovery which occurred in the threesix months ended MarchJune 31,30, 2025.
During the six months ended June 30, 2026, we recorded $58,472 of income tax expense as compared to $3,809 during the six months ended June 30, 2025. As mentioned above, we anticipate having some amount of tax liability for profits we may realize moving forward, as certain NOLs carried forward no longer 100% offset taxable income, but 80% offset instead.
During both the three months ended March 31, 2026 and 2025, we recorded insignificant amounts of income tax expense.
We had aggregate debt outstanding (net of debt issuance and debt discount costs) of $8.7$8.3 million and $9.1 million as of MarchJune 31,30, 2026 and December 31, 2025, respectively. Recurring debt principal repayments (excluding the line of credit) aggregated $0.4$0.8 million during both the threesix months ended MarchJune 31,30, 2026 and 2025. We anticipate that recurring debt principal repayments will aggregate approximately $1.6 million during the year ending December 31, 2026. Our $1.0 million line of credit, which bears interest at the National Prime Rate per annum, is currently available until September 11, 2026. No draw on our line of credit was outstanding as of MarchJune 31,30, 2026, or December 31, 2025.
Interest expense (excluding amortization of debt issuance and debt discount costs) was approximately $97,000$189,027 and $117,000$231,110 during the threesix months ended MarchJune 31,30, 2026,2026 and 2025, respectively. Our debt bears interest at fixed rates, which on a blended basis amounts to 4.3%4.29% per annum.annum as of June 30, 2026. We anticipate that interest expense (excluding amortization of debt issuance and debt discount costs) will be $367,000 during the year ending December 31, 2026.
In April of 2024, we entered into our ATM Agreement, which allows us to offer and sell up to $11 million of shares of our common stock. As of MarchJune 31,30, 2026, we have the capacity to sell $6 million of shares under the ATM Agreement but no pending plan to issue additional shares under that arrangement.
(1) There were 1,076,260 and 801,760 shares of common stock reserved for issuance for stock options that were outstanding as of March 31, 2026 and December 31, 2025, respectively.
Net cash provided by operating activities increased $2.0$3.4 million during the
three six months ended
March 31,June 30, 2026 as compared to the
three six months ended
March 31,June 30, 2025. The increase was primarily due to a $0.5$1.8 million increase in net income, $0.8which benefitted from a $2.0 million settlement as the result of a contract dispute with a prior contract manufacturer for Re-Tain®. Working capital changes also contributed to the increase, including i) $1.4 million less cash used for inventory,inventory $0.4as millionfinished lessgoods were built up in 2025, ii) cash usedoutflows for accounts payable and accrued expenses,expenses decreased by $0.8 million primarily due to timing of payroll and $0.3executive bonus payments, and iii) $0.9 million additionalless cash provided by accounts receivable.receivable due to timing of order fulfillment.
Net cash used for investing activities decreasedincreased $0.2$0.4 million during the
three six months ended
March 31,June 30, 2026 as compared to the
three six months ended
March 31,June 30, 2025. The decreaseincrease was primarily due to aspending reduction inon capital expenditures.expenditures related to investments supporting the first phase of the First Defense® planned production increase. See “First Defense® Manufacturing Expansion” section above for further information.
Net cash used for financing activities increased $0.2 million during the six months ended June 30, 2026 as compared to the six months ended June 30, 2025 primarily due to the absence of $0.3 million proceeds from the ATM Agreement that were received in the six months ended June 30, 2025, partly offset by $0.2 million of proceeds from the exercise of stock options during the six months ended June 30, 2026.
Net cash used for financing activities decreased an insignificant amount during the
three months ended
March 31, 2026 as compared to the
three months ended
March 31, 2025.
ICCC insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 1 Form 4 filing (1 insider, 1 trade date, 8,000 shares, about $76.0K) and open-market sales in 0 filings. Net open-market shares: 8,000 (purchases minus sales); net value about $76.0K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-06-18 | Te Boekhorst Paul Francis Olivier |
Open-market purchase | 8,000 | $9.50 | $76.0K |
Well-known investors holding ICCC (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Renaissance Technologies | 2026-06-30 | 171,089 | $1.7M | 0.0% | Added 13% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 40,503 | $407.1K | 0.0% | Added 13% |