UNITED
STATES

SECURITIES
AND EXCHANGE COMMISSION

Washington,
D.C. 20549



FORM
10-K/A

Amendment No. 1



xANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934



For the fiscal year ended December 31,
2011



 ̈TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
 SECURITIES EXCHANGE ACT OF 1934



001-12934

(Commission file number)



ImmuCell Corporation

(Exact name of Registrant as specified
in its charter)

|Delaware                        | 01-0382980         
|------------------------------- | -------------------
|(State or other jurisdiction of | (I.R.S. Employer   
|incorporation or organization)  | Identification No.)



|56 Evergreen Drive, Portland, Maine      | 04103     
|---------------------------------------- | ----------
|(Address of principal executive offices) | (Zip Code)



Registrant’s telephone number:
(207) 878-2770



Securities registered pursuant to Section
12(b) of the Act:

None

Securities registered pursuant to Section
12(g) of the Act:



Common Stock, par value $0.10 per share

(Title of class)



Indicate by check mark if the Registrant is a well-known seasoned
issuer, as defined in Rule 405 of the Securities Act.

Yes  ̈ No x



Indicate by check mark if the Registrant is not required to
file reports pursuant to Section 13 or 15(d) of the Act. Yes  ̈ No x



Indicate by check mark whether the Registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes x No  ̈



Indicate by check mark whether the Registrant has submitted
electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the
Registrant was required to submit and post such files).

Yes x No  ̈



Indicate by check mark if disclosure of delinquent filers pursuant
to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of Registrant’s knowledge,
in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. x



Indicate by check mark whether the Registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. Large accelerated filer  ̈
Accelerated filer  ̈ Non-accelerated filer  ̈
Smaller reporting company x



Indicate by check mark whether the Registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act). Yes £ No S



The aggregate market value of the voting and non-voting common
equity held by non-affiliates at June 30, 2011 was approximately $17,297,000, based on the closing sales price on June 30, 2011
of $7.90 per share.



The number of shares of the Registrant’s common stock
outstanding at March 26, 2012 was 3,019,034.



Documents incorporated by reference: Portions of the Registrant’s
definitive Proxy Statement to be filed in connection with the 2012 Annual Meeting of Stockholders are incorporated by reference
into Part III hereof.











ImmuCell Corporation

EXPLANATORY NOTE



This Amendment No. 1 to the Annual Report
on Form 10-K/A (the “Amendment”) amends the Annual Report on Form 10-K of ImmuCell Corporation (the “Company”)
for the year ended December 31, 2011 (the “Original Filing”), that was originally filed with the U.S. Securities and
Exchange Commission (SEC) on March 27, 2012. The Amendment is being filed solely to furnish a revised Exhibit 31 to the Original
Filing. The Amendment revises the Exhibit Index and Section #4 to Exhibit 31 included in Part II, Item 15 of the Original Filing.



Except as described above, the Amendment
does not modify or update the disclosures presented in, or exhibits to, the Original Filing in any way. Those sections of the
Original Filing that are unaffected by the Amendment have been included herein as required by the SEC. The Amendment continues
to speak as of the date of the Original Filing. Furthermore, the Amendment does not reflect events occurring after the filing
of the Original Filing. Accordingly, the Amendment should be read in conjunction with the Company’s other filings made with
the SEC pursuant to Section 13(a) or 15(d) of the Exchange Act subsequent to the filing of the Original Filing.











ImmuCell Corporation



TABLE OF CONTENTS

December 31, 2011



|         | PART I                                                                                         |            
|-------- | ---------------------------------------------------------------------------------------------- | -----------
|         |                                                                                                |            
|ITEM 1.  | Description of Business                                                                        | 1          
|         |                                                                                                |            
|ITEM 1A. | Risk Factors                                                                                   | 9          
|         |                                                                                                |            
|ITEM 2.  | Description of Property                                                                        | 13         
|         |                                                                                                |            
|ITEM 3.  | Legal Proceedings                                                                              | 13         
|         |                                                                                                |            
|ITEM 4.  | Mine Safety Disclosures                                                                        | 13         
|         |                                                                                                |            
|         | PART II                                                                                        |            
|         |                                                                                                |            
|ITEM 5.  | Market for Common Equity, Related Stockholder Matters and Purchases of Equity Securities       | 14         
|         |                                                                                                |            
|ITEM 6.  | Selected Financial Data                                                                        | 14         
|         |                                                                                                |            
|ITEM 7.  | Management’s Discussion and Analysis of Financial Condition and Results of Operations          | 15         
|         |                                                                                                |            
|ITEM 7A. | Quantitative and Qualitative Disclosures about Market Risk                                     | 22         
|         |                                                                                                |            
|ITEM 8.  | Financial Statements                                                                           | 22         
|         |                                                                                                |            
|ITEM 9.  | Changes In and Disagreements With Accountants on Accounting and Financial Disclosure           | 23         
|         |                                                                                                |            
|ITEM 9A  | Controls and Procedures                                                                        | 23         
|         |                                                                                                |            
|ITEM 9B. | Other Information                                                                              | 23         
|         |                                                                                                |            
|         | PART III                                                                                       |            
|         |                                                                                                |            
|ITEM 10. | Directors, Executive Officers and Corporate Governance                                         | 24         
|         |                                                                                                |            
|ITEM 11. | Executive Compensation                                                                         | 24         
|         |                                                                                                |            
|ITEM 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 24         
|         |                                                                                                |            
|ITEM 13. | Certain Relationships and Related Transactions and Director Independence                       | 24         
|         |                                                                                                |            
|ITEM 14. | Principal Accounting Fees and Services                                                         | 24         
|         |                                                                                                |            
|ITEM 15. | Exhibits and Financial Statement Schedules                                                     | 24         
|         |                                                                                                |            
|         | Audited Financial Statements                                                                   | F-1 to F-18
|         |                                                                                                |            
|         | Signatures                                                                                     |            











ImmuCell Corporation



PART I



ITEM 1 – DESCRIPTION OF BUSINESS



Summary



ImmuCell Corporation was founded in 1982
and completed an initial public offering of common stock in 1987. After achieving approval from the U.S. Department of Agriculture
(USDA) to sell First Defense® in 1991, we focused most of our efforts during the 1990’s developing
human product applications of the underlying whey protein purification technology. Beginning in 1999, we re-focused on First
Defense® and other products for the dairy industry. Our purpose is to create scientifically-proven and practical
products that result in a measurable economic impact on animal health and productivity in the dairy and beef industries.



In 2000, we began the development of Mast
OutÒ, our Nisin-based treatment for subclinical mastitis in lactating
dairy cows. No sales of this product can be made without prior approval from the Center for Veterinary Medicine, U.S. Food and
Drug Administration (FDA). Because dairy producers are required to discard milk for a period during and after treatment with all
currently marketed mastitis treatment products, it is generally current practice to only treat mastitis when the disease has progressed
to the clinical stage where the milk from an infected cow cannot be sold. Because milk from cows treated with Mast OutÒ
may be allowed to be sold without a milk discard period, we believe we could revolutionize the way that mastitis is treated by
removing the milk discard penalty, which would make earlier treatment of subclinically infected cows economically feasible. No
other mastitis treatment product on the market can offer this value proposition. At present, most dairy producers simply do not
treat subclinically infected cows or they cull the affected animals from the herd because of the milk discard requirement. Mast
OutÒcould be uniquely positioned in the market as both
a treatment for subclinical mastitis and as a tool to prevent some cases of clinical mastitis. Mast OutÒcould also be used as a tool to improve milk quality, which could result in higher milk revenue to a producer who could
earn milk quality premiums.



During the twelve-year period that began
on January 1, 2000 and ended on December 31, 2011, we invested the aggregate of $15,685,000 in product development expenses. Approximately
54% of this amount pertained directly to the development of Mast OutÒ.
This estimated allocation to Mast OutÒ reflects only direct expenditures
and includes no allocation of product development or administrative overhead expenses. Approximately $2,375,000 of this investment
was offset by product licensing revenues. We have decided not to completely fund internally the remaining investment principally
related to manufacturing scale-up and preparations of full-scale batches of Mast OutÒ.
We are engaged in negotiations with potential partners that may fund this investment as well as the marketing expenses for product
launch and sales. Our objective from a successful partnership would be to benefit from the gross margin on product that we produce
and sell into distribution. We expect that a partner would benefit from a to-be-negotiated mark-up on the product sold, exclusively
by such partner, into distribution. This strategic decision not to fund these large, late-stage development expenses should allow
us to return to positive net operating income during 2012.



With our 1999 shift to re-focus on animal
health products, we were able to record net income for each year during the nine-year period that began on January 1, 1999 and
ended on December 31, 2007. We believe that this conservative approach to financial management put us in a position to weather
a significant financial downturn like the one we have been experiencing, while funding Mast Out®product
development expenses. A significant and controlled investment in the development of Mast Out® resulted in
net losses for each year during the four-year period that began on January 1, 2008 and ended on December 31, 2011. We had more
than enough cash and short-term investments to fund these losses. We expect to return to positive net operating income during 2012
based principally on the sales of First Defense®. This strategy, which resulted in nine years of profits
followed by four years of losses, has allowed us to fund our operations and improve our net financial position, as demonstrated
in the following table (in thousands, except for percentages):



|                                                  |  | At December 31, 1998 |       |  |   |  | Net $ increase  over thirteen-year period |   |       |  |  | At December 31, 2011 |  |   | Net % increase 
over thirteen-year
period | 
|------------------------------------------------- |  | -------------------- | ----- |  | - |  | ----------------------------------------- | - | ----- |  |  | -------------------- |  | - | ----------------------------------------- | 
|Cash, cash equivalents and short-term investments |  | $                    | 1,539 |  | + |  |                                           | $ | 3,421 |  |  | =                    |  | $ | 4,960                                     | 
|Net working capital                               |  |                      | 1,866 |  | + |  |                                           |   | 4,650 |  |  | =                    |  |   | 6,516                                     | 
|Total assets                                      |  |                      | 3,145 |  | + |  |                                           |   | 7,846 |  |  | =                    |  |   | 10,991                                    | 
|Stockholders’ equity                              |  | $                    | 2,248 |  | + |  |                                           | $ | 6,772 |  |  | =                    |  | $ | 9,020                                     | 



1







ImmuCell Corporation



We had approximately 2,429,000 shares of
common stock outstanding as of December 31, 1998 in comparison to 3,004,000 as of December 31, 2011. There were approximately 480,000
and 236,000 shares of common stock reserved for issuance under stock options that were outstanding as of December 31, 1998 and
2011, respectively. During the thirteen-year period that began January 1, 1999 and ended on December 31, 2011, we invested the
aggregate of $16,498,000 in product development expenses.



During 2006, we initiated efforts to become
compliant with current Good Manufacturing Practice (cGMP) regulations in our manufacturing operations. Compliance with cGMP regulations
requires a sustained investment that we believe further increases our products’ quality and may open access to international
markets where such standards are imposed. At the same time, we are investigating ways to develop new products utilizing our First
Defense®and Nisin technologies.



Animal Health Products for the Dairy and Beef Industries



Our lead product, First DefenseÒ,
is manufactured from cows’ colostrum using our proprietary vaccine and whey protein purification technologies. The target
disease, bovine enteritis (calf scours), causes diarrhea and dehydration in newborn calves and often leads to serious sickness
and even death. First DefenseÒ is the only USDA-licensed, orally
delivered scours preventive product on the market for calves with claims against E. coli K99 and coronavirus (two leading
causes of scours). We are a leader in the scours prevention market with this product. During the fourth quarter of 2011, we sold
the 11,000,000th dose of First DefenseÒ, since receiving
USDA approval of this product in 1991. We believe that this milestone demonstrates the value of our technology and the long-term
market acceptance of our product. During the second quarter of 2006, certain regional organic certifying agencies determined that
the ingredients in First DefenseÒare in compliance with the National
Organic Program (NOP) and may be considered for use on organic farms.



First Defense® provides
bovine antibodies that newborn calves need but are unable to produce on their own immediately after birth. Due to natural variability
in colostrum, newborn calves do not always get the antibodies they need from maternal colostrum. First Defense®
competes with scours vaccines that are given to the mother cow and to the calf. Despite the best-managed dam (mother cow) vaccine
program, colostrum quality is variable. Further, we know that newborn calves respond poorly, if at all, to vaccines, and the immune
system must be given time to develop a response to vaccines. Colostrum feeding must be delayed when calf vaccines are used, and
it is not good calf health practice to delay the feeding of colostrum while waiting for a vaccine response to be mounted. First
Defense®provides immediate and preformed immunity (Immediate ImmunityTM) when calves need it
most - during the first few critical days of life. The direct, two-part mode-of-action of First Defense®
delivers specific immunoglobulins at the gut level to immediately protect against disease, while also providing additional antibodies
that are absorbed into the bloodstream. These circulating antibodies function like a natural timed-release mechanism, as they are
re-secreted into the gut later to provide extended protection. A single dose of First Defense® provides a
guaranteed level of protection proven to reduce mortality and morbidity from two major causes of calf scours. Studies have shown
that calves that scour are more susceptible to other diseases and under-perform calves that do not contract scours. First Defense®
is convenient to use. A calf needs to receive only one bolus of First Defense®within the first twelve hours
after birth. The product is stored at room temperature and no mixing is required before it is given to the calf. There is no required
slaughter withdrawal period for calves that are given First Defense®.



In 1999, we acquired Wipe OutÒ
Dairy Wipes, which is our second leading source of product sales revenue. That transaction included the purchase of certain
equipment, trademarks and a license of intellectual property, including several issued patents, covering the product and rights
to develop skin and environmental sanitizing applications of the Nisin technology. Wipe OutÒ
Dairy Wipes consist of biodegradable towelettes that are pre-moistened with a Nisin-based formulation to prepare the teat
area of a cow in advance of milking. Nisin is an antibacterial peptide that has been demonstrated in clinical studies to be an
effective aid in the reduction of mastitis-causing organisms in dairy cows. Mastitis is a very common infection in dairy cows that
results in inflammation of the mammary gland. Milking regulations require that the teat area of cows be cleaned, sanitized and
dried for each milking. Producers use a variety of methods including dips and paper or cloth towels. Our wipes are made from a
non-woven fabric that is strong enough to allow for a vigorous cleaning but still biodegradable for disposal. The wiping process
can also help promote milk letdown. Wipe OutÒ Dairy Wipes are
manufactured in compliance with cGMP regulations, as required by federal law.



2







ImmuCell Corporation



In 2001, we began to offer our own, internally
developed California Mastitis Test (CMT). CMT can be used for bulk tank as well as individual cow sample monitoring
and can be used to determine which quarter of the udder is mastitic. This test can be performed at cow-side for early detection
of mastitis. CMT products are also made by other manufacturers and are readily available to the dairy producer. The wholesale
price of our product is generally lower than the competitive products that were present in the market when we initiated commercial
sales.



Sales and Markets



Our sales and marketing
team currently consists of one director and two regional sales managers. Effective for 2011 and 2012, and renewable for 2013 and
2014 if certain sales growth objectives are met, we entered into a sales and marketing collaboration with Agri Laboratories Ltd.
of St. Joseph, Missouri, (AgriLabsÒ), under which the AgriLabs sales
and marketing teams are working with us to expand market demand for First DefenseÒ.
The AgriLabs national marketing network consists of 20 independent distributors operating approximately 125 branch locations with
more than 700 sales representatives. AgriLabs has developed and markets more than 750 products through its own branded product
lines. The AgriLabs sales team is comprised of approximately 22 well-trained, experienced professionals that cover the United States.
The manner in which we sell and distribute our products depends, in large measure, upon the nature of the particular product, its
intended users and the country in which it is sold. The distribution channel selected is intended to address the particular characteristics
of the marketplace for a given product. First DefenseÒ is sold
primarily through major veterinarian distributors. Sales are normally seasonal, with higher sales expected during the first quarter.
Harsh winter weather and severe temperature fluctuations cause stress to calves, and calves under stress are more susceptible to
scours, which contributes to the seasonality in the sales of this product. Sales of this product into the beef industry are highly
seasonal because most beef calves are born between January and April each year and our product is designed to be administered to
calves immediately after birth. We sell Wipe OutÒ Dairy Wipes,
and CMT to distributors, bovine veterinarians and directly to producers. Sales and marketing expenses amounted to 17%, 15%
and 9% of product sales in the years ended December 31, 2011, 2010 and 2009, respectively. Our budget guideline for 2012 is to
invest less than 20% of product sales in sales and marketing expenses.



First DefenseÒ
is generally sold through large, financially strong distributors, which we believe has resulted in minimal bad debt with respect
to this product. We provide for a 50% account credit for domestic distributors on expired First DefenseÒ
product, which has a two-year shelf life resulting in an immaterial amount of returns. Promotional merchandise is given to certain
customers at times because we believe it enhances brand recognition. Additionally, advertising, training meetings, incentive programs,
direct mail initiatives and face-to-face solution selling are tactics we use to create brand loyalty.



International product
sales represented approximately 19%, 18% and 22% of our total product sales for the years ended December 31, 2011, 2010 and 2009,
respectively. The majority of these international sales were to Canada. We currently price our products in U.S. dollars. An increase
in the value of the dollar in any country in which we sell products may have the effect of increasing the local price of such products,
thereby leading to a reduction in demand. Conversely, to the extent that the value of the dollar declines with respect to any other
currency, our competitive position may be enhanced.



We continue our efforts to grow sales of
First DefenseÒ in North America, where there are approximately
9,000,000 dairy cows in the United States and 1,000,000 dairy cows in Canada. We believe that even greater market opportunities
exist in other international territories. There are estimated to be approximately 23,000,000 dairy cows in the European Union,
another 8,000,000 in Russia, another 7,000,000 in Australia and New Zealand and another 800,000 in Japan. These figures do not
consider potential sales in the beef markets. Industry practices, economic conditions and cause of disease may differ in these
foreign markets from what we experience in the United States. We introduced First DefenseÒ
into South Korea in 2005 and its equivalent into Japan in 2007 through collaborations with in-country distributors.



Mastitis is estimated
to cost U.S. dairy producers approximately $2 billion per year, making it the leading cause of economic harm to the dairy industry.
These losses include the cost of treatment products, reduced milk production, discarded milk and increased cull cows. We estimate
that the U.S. market for the use of antibiotics to treat clinical mastitis (those cases where cows are producing abnormal milk)
in lactating cows is approximately $40,000,000 per year and that similar market opportunities also exist outside of the United
States and for the treatment of dry (non-lactating) cows. Some observers believe the market could be larger.



3







ImmuCell Corporation



Because milk from cows
treated with traditional antibiotics must be discarded for a period of time during and after treatment due to concerns about antibiotic
residue in the milk, currently it is not common practice to treat subclinical mastitis (those cases where cows have infected udders,
but still produce saleable milk). Subclinical mastitis is associated with its own significant economic losses and is recognized
as a significant contributor to clinical mastitis cases. Current intervention strategies are considered inadequate and generally
not cost-effective due to milk discard requirements. The ability to treat such cases without a milk discard could revolutionize
the way mastitis is managed in a herd. Without a milk discard requirement, we believe Mast OutÒ
could expand the subclinical mastitis treatment market niche. We are not aware of any other FDA-approved intramammary mastitis
treatment product that has such a “zero discard” claim. While the benefit of treating clinical mastitis is widely known,
there is a growing awareness of the cascade of adverse events and conditions associated with subclinical mastitis, including reduced
or foregone milk quality premiums, lower milk production, increased abortions and increased cull rates. Some industry experts have
estimated that subclinical mastitis costs the U.S. dairy industry approximately $1 billion per year. It is difficult to evaluate
the potential size of the as-yet undeveloped subclinical mastitis treatment market. The FDA may grant a period of five years of
market exclusivity forMast OutÒ (meaning the FDA might not grant
approval to a second and similar NADA for a period of five years after the first NADA approval is granted) under Section 512(c)(2)F
of the Federal Food, Drug, and Cosmetic Act. Regulations in the European Union will likely require that Mast OutÒ
be sold subject to a milk discard requirement in that territory, although the duration of the milk discard requirement may be shorter
than the discard requirement applicable to competitive products on the market.



Many fear that the possible overuse of antibiotics
in livestock could undermine the effectiveness of drugs to combat human illnesses and may be a contributing factor to the rising
problem of bacterial drug resistance. The FDA is committed to addressing its concern with respect to this important public health
issue. Citing concerns about untreatable, life-threatening infections in humans, new FDA regulations proposed to go into effect
in April 2012 would further restrict the use of cephalosporins in food animals. Effective January 2012, new USDA regulations are
expected to reduce the allowable level of somatic cell counts in milk to 400,000 at the farm level in order to qualify for an EU
export certification. In late 2011, The Dutch Veterinary Society proposed strict guidelines for veterinary use of antibiotics in
the EU. This current environment could be favorable to the introduction of a new product such as Mast OutÒas an alternative to traditional antibiotics. We continue to believe that this product opportunity justifies ongoing
product development efforts.



Product Development



In 1999, we shifted the
primary focus of our product development efforts from applications of our whey protein purification technology for humans to scientifically-proven
and practical products that result in a measurable economic impact on animal health and productivity in the dairy and beef industries.
This strategy was maintained through 2011 and is expected to continue. We spent approximately $1,720,000, $1,493,000 and $1,645,000
on product development activities during the years ended December 31, 2011, 2010 and 2009, respectively. We expect lower product
development expenses during the year ending December 31, 2012. If a partner agrees to fund the completion of the Mast OutÒ
product development effort, these expenses could increase, but only if they are off set, at least in part, by the funds that we
would receive from the potential strategic collaboration.



In 2000, we acquired an
exclusive license from Nutrition 21, Inc. (formerly Applied Microbiology Inc. or AMBI) to develop and market Nisin-based products
for animal health applications, which allowed us to initiate the development of Mast OutÒ,
our intramammary infusion product. In 2004, we paid Nutrition 21 approximately $965,000 to buy out this royalty and milestone-based
license to Nisin, thereby acquiring control of the animal health applications of Nisin. Nisin, the same active ingredient contained
in Wipe OutÒ Dairy Wipes, isan antibacterial peptide.
Nisin is known to have activity against most gram positive and some gram negative bacteria. Nisin is a well characterized substance,
having been used in food preservation applications for over 50 years. Nisin has been granted GRAS (Generally Regarded as Safe)
status by the FDA for food preservative applications, which may be of some help in obtaining approval for the use of Mast OutÒ
on organic farms. Food-grade Nisin, however, cannot be used in pharmaceutical applications because of its low purity. Our Nisin
technology includes methods to achieve pharmaceutical-grade purity.



4







ImmuCell Corporation



In 2004, we entered into a product development
and marketing agreement with Pfizer Animal Health, a division of Pfizer, Inc., covering Mast OutÒ.
Under that agreement (as amended and supplemented and later terminated), we received $2,375,000 in payments from Pfizer. Pfizer
elected to terminate the agreement in 2007. Soon thereafter, Pfizer returned to us all rights, data, information, files, regulatory
filings, materials and stocks of Nisin and Nisin producing cultures relating to the development of Mast Out Ò.
We believe that Pfizer’s decision to terminate the agreement was not based on any unanticipated efficacy or regulatory issues.
Rather, we believe Pfizer’s decision was primarily market driven, largely relating to their concern that the use of Mast
OutÒ might require specific treatment restrictions at the herd level
to avoid a problem in the manufacture of cheese.



Due to the zero milk discard feature, there
is a risk that Nisin from milk of cows treated with Mast OutÒcould interfere with the manufacture of certain (but not all) commercial cultured dairy products, such as some kinds
of cheese and yogurt, if a process tank contains milk from a high enough percentage of treated cows. We have conducted a formal
risk assessment to quantify the impact that milk from treated cows may have on cultured dairy products. This study concluded that
the dilution of milk from treated cows through comingling with milk from untreated cows during normal milk hauling and storage
practices reduces the risk of interference with commercial dairy cultures to a negligible level when Mast OutÒ
is used in accordance with the product label. Milk from treated cows that is sold exclusively for fluid milk products presents
no such risk. Another risk is that Mast OutÒ likely will be priced
at a premium to the traditional antibiotic products currently on the market, which are all sold subject to a milk discard requirement.
However, we believe that the product’s value proposition demonstrates a return on the investment to the producer that will
justify this premium.



In 2007, we began the
production of pivotal batches of drug product to fulfill the regulatory requirements of effectiveness, stability, target animal
safety and human food safety. Commercial introduction of Mast OutÒ
in the United States is subject to approval of our New Animal Drug Application (NADA) by the Center for Veterinary Medicine, U.S.
Food and Drug Administration (FDA), which approval cannot be assured. Foreign regulatory approvals would be required for sales
in key markets outside of the United States and would involve some similar and some different requirements. The NADA is comprised
of five principal Technical Sections subject to the FDA’s phased review of a NADA. By statute, each Technical Section submission
is subject to a six-month review cycle by the FDA. The current status of our work on these Technical Sections is as follows:



1) Environmental Impact:
During the third quarter of 2008, we received the Environmental Impact Technical Section Complete Letter from the FDA.



2) Effectiveness: During
the second quarter of 2008, we initiated the pivotal effectiveness study. Positive results from the study were announced during
the third quarter of 2009. With enrollment of approximately 300 qualified cows with subclinical mastitis, the Mast OutÒ
treatment group showed a statistically highly significant overall cure rate in comparison to the placebo group. We believe that
the breakdown of the data by species suggests both the necessary numerical superiority and clinical relevancy to support robust
product performance in the field. For example, one of the most important mastitis pathogens, coagulase-negative staphylococci,
predominated in our study, and Mast OutÒachieved
almost 10-fold higher cure rates than the placebo-treated animals against this pathogen. Further, Mast OutÒtreatment was associated with a statistically significant (p<0.005) reduction in milk somatic cell count (SCC), which
is an important measure of milk quality. During the third quarter of 2010, we made our first submission of the Effectiveness Technical
Section. This 65 volume submission contained the results from our pivotal trial conducted from 2008 to 2009 as well as all supporting
data related to the effectiveness of Nisin, demonstrating the effectiveness of Mast OutÒ
in the field at a level similar to currently marketed intramammary antibiotics and confirming prior results from two major field
studies conducted since 2003. During the first quarter of 2011, we received an Effectiveness Technical Section Incomplete Letter
from the FDA. The FDA requested additional information and clarification in the areas of raw data, subject eligibility and statistical
analyses and has requested that certain treatment outcomes be changed or justified. Additional clinical studies were not required.
Our response to the FDA, which was submitted during the fourth quarter of 2011, does not materially change our initial conclusions
about the product’s effectiveness. We expect to receive the FDA’s response to this second submission during the second
quarter of 2012 after one, six-month review cycle.



3) Human Food Safety
(HFS): The HFS Technical Section submission was made during the fourth quarter of 2010. This Technical Section determines if
a milk discard period or meat withhold period will be required. This Technical Section includes several subsections such as:
a) toxicology, b) total metabolism, c) effects of drug residues in food on human intestinal microbiology, d) effects on
bacteria of human health concern (antimicrobial resistance) and e) pivotal residue chemistry. During the second quarter of
2011, we announced that the FDA had accepted our pivotal Nisin residue in milk data and granted Mast OutÒ
a zero milk discard time and a zero meat withhold period. Before we can obtain the Technical Section Complete Letter, we must
adapt our analytical method that measures Nisin residues in milk around the newly assigned tolerance limit and transfer that
method to the FDA laboratory. We anticipate being able to complete this work by the second quarter of 2012, at which point we
would be eligible to receive the Technical Section Complete Letter from the FDA.



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ImmuCell Corporation



4) Target Animal Safety:
Under a protocol approved in advance by the FDA, the pivotal Target Animal Safety trial was completed during the first quarter
of 2010. We submitted the Target Animal Safety Technical Section to the FDA for review during the third quarter of 2011. We received
an end-review amendment (ERA) request from the FDA in response to this submission during the first quarter of 2012 after one, six-month
review cycle. An ERA is requested when the FDA has completed its review of a submission and has determined that the submission
of additional non-substantial data or information would likely complete the submission. We filed the ERA within the required time
frame and expect to receive the FDA’s response to this ERA submission during the second quarter of 2012.



5) Chemistry, Manufacturing
and Controls (CMC): We have entered into agreements with three manufacturers to produce inventory for us utilizing our proprietary
technology and processes. First, a long-term, exclusive supply agreement with Plas-Pak Inc. of Norwich, Connecticut covers the
proprietary syringe that was developed specifically for Mast OutÒ.
These syringes were used for all pivotal studies of Mast OutÒ.
Second, a Development and Manufacturing Agreement with Lonza Sales, Ltd. of Basel, Switzerland provides for the exclusive manufacture
of the Active Pharmaceutical Ingredient (API). The Lonza site in Europe is FDA-approved, compliant with current Good Manufacturing
Practices (cGMP) regulations and subject to future FDA approval and inspection. Through discussions with partner prospects, we
have recently determined that current Lonza contract provisions could result in unfavorable product volumes and costs. Therefore,
we are currently seeking contractual amendments while simultaneously investigating a self-sourcing strategy. We are seeking partner
funding and exploring state financial incentives for such a plant investment. We are in discussions with multiple prospective partners.
When or if a partnership to fund the completion of the development of Mast OutÒ
will be initiated is not known currently. We will make a public announcement of such a deal if and when it occurs. Third, an exclusive
Contract Manufacture Agreement with Norbrook Laboratories Limited of Newry, Northern Ireland, an FDA-approved drug product manufacturer,
covers the formulation of the API into drug product, the sterile-fill of syringes and the final packaging. Norbrook provided these
services for clinical material used in all pivotal studies of Mast OutÒ.
The CMC Technical Section submission requires the identification of all facilities that will be used in the manufacture of the
product. We expect to make a first submission of this Technical Section during the second quarter of 2012, and we anticipate that
at least two, six-month review cycles by the FDA will be required. Obtaining FDA approval of the CMC Technical Section defines
the critical path to the submission of the administrative NADA to the FDA.



6) Several Administrative
Requirements: After obtaining the final Technical Section Complete Letter and after preparing materials responsive to other administrative
requirements, the administrative NADA submission can be assembled for review by the FDA. This final submission would be subject
to a statutory sixty-day review period. Product produced for the validation batches under the CMC Technical Section could be sold
upon FDA approval.



In addition to our work
on Mast OutÒ, we are actively exploring further improvements,
extensions or additions to our current product line. For example, we currently are developing therapies that could prevent scours
in calves caused by enteric pathogens other than E. coli K99 and bovine coronavirus (the current First DefenseÒ
claims). In connection with that effort, during the second quarter of 2009 we entered into an exclusive license with Baylor College
of Medicine covering certain rotavirus vaccine technology. This perpetual license (if not terminated for cause) is subject to milestone
and royalty payments. Results from pilot studies completed during the first quarter of 2009 justified continued product development.
We completed a pivotal effectiveness study of this experimental, three-claim formulation during the third quarter of 2011 without
seeing the anticipated level of effectiveness needed for regulatory approval and market acceptance. We are currently conducting
additional pilot studies of different formulations of this antibody preparation. If positive results from these pilot studies are
achieved, a second pivotal effectiveness study could be initiated during 2012.



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ImmuCell Corporation



We are developing new
product applications of ourFirst Defense TechnologyTM, which is a unique whey protein concentrate that is purified
utilizing our proprietary whey protein processing methods. It does not carry the claims of our USDA-licensed product. We initiated
sales of our First Defense TechnologyTM with AgriLabs as a feed ingredient in a colostrum supplement. We also
initiated sales of First Defense TechnologyTM in a bulk powder format (no capsule), which is delivered with a
scoop. Thirdly, we initiated a limited launch of a tube delivery format of our First Defense TechnologyTM in
a gel solution. Lastly, we initiated sales of our First Defense TechnologyTM with Milk Products, LLC of Chilton,
Wisconsin as a feed ingredient in a colostrum replacer. As additional opportunities arise to commercialize our own technology,
or licensable technology, we begin new development projects. While we continue to pursue internally funded product development
programs, we also remain interested in acquiring new products and technologies that fit with our sales and marketing focus on the
dairy and beef industries.



Competition



Our competition in the
animal health market includes other biotechnology companies and major animal health companies. Many of these competitors have substantially
greater financial, marketing, manufacturing and human resources and more extensive product development capabilities than we do.
Many may be capable of developing technologies and/or products that are superior to ours, or may be more successful in developing
production capability or in obtaining required regulatory approvals. We would consider any company that sells an antibiotic to
treat mastitis, such as Pfizer Animal Health, Merck Animal Health and Boeringher Ingelheim, to be among the potential competitors
for Mast OutÒ.



We may not be aware of
competition that we face from other companies. Our competitive position will be highly influenced by our ability to attract and
retain key scientific and managerial personnel, to develop proprietary technologies and products, to obtain USDA or FDA approval
for new products, to effectively promote and market our products and to continue to profitably sell our current products. We currently
compete on the basis of product performance, price and distribution capability. We continue to monitor our network of independent
distributors to maintain our competitive position.



We believe that First
DefenseÒ offers two significant competitive advantages over other
oral antibody products on the market. First, its capsule form does not require refrigeration and provides ease of administration.
Second, First DefenseÒ provides protection against the leading
cause of calf scours (E. coli) and additional protection against coronavirus, another leading cause of the disease. In addition
to direct competition from oral antibody products, First DefenseÒ
also competes for market share against vaccine products that are used to increase the production of antibodies by the dam that
can then be transferred through the mother’s milk to the calf and against vaccine products that are administered to the newborn
calf. The immediate and preformed immunity (Immediate ImmunityTM) that First DefenseÒ
provides to the calf is a competitive advantage over the vaccine products. First DefenseÒalso competes against scours preventives that are not licensed by the USDA.



There are many products
on the market that may be used in place of Wipe OutÒ Dairy Wipes,
and our product sells at a premium to most of them. These products include teat dips, teat sprays and other disposable and washable
towel products offered by several different companies. Competitive advantages of Wipe OutÒ
Dairy Wipes include that they are convenient to use, they do not irritate the udder, they do not adulterate the milk and they
are biodegradable.



Patents, Proprietary Information and Trademarks



In connection with the
December 1999 acquisition of Wipe OutÒ Dairy Wipesand the April
2000 license to all veterinary applications of Nisin from Nutrition 21, Inc., we acquired a license to six patents. In November
2004, we bought out certain future milestone and royalty obligations under the 1999 and 2000 licenses, which principally resulted
in a fully paid, perpetual license related to the animal health applications of Nisin. Four of these six patents have expired or
are expiring and one of the two longer-term patents may be subject to a patent term extension. In 2004, we were issued U.S. Patent
No. 6,794,181 entitled “Method of Purifying Lantibiotics” covering a manufacturing process for pharmaceutical-grade
Nisin.



In 2000, we were issued
U.S. Patent No. 6,074,689 entitled “Colonic Delivery of Protein or Peptide Compositions” covering the method of formulation
that can be used to deliver proteins to the colon. In 1999, we acquired an exclusive license for pharmaceutical applications to
U.S. Patent No. 5,773,000 entitled “Therapeutic Treatment of Clostridium difficile Associated Diseases” from
GalaGen, Inc. In 2002, we acquired ownership of this patent from the court administering the bankruptcy proceedings of GalaGen.
These patents are included in a royalty-bearing license we granted to Immuron, Ltd. (formerly known as Anadis) of Australia in
2008 for their use in the development of milk antibody products for humans.



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ImmuCell Corporation



In the future, we may
file additional patent applications for certain products under development. There can be no assurance that patents will be issued
with respect to any pending or future applications.



In some cases, we have
chosen (and may choose in the future) not to seek patent protection for certain products or processes. Instead, we have sought
(and may seek in the future) to maintain the confidentiality of any relevant proprietary technology through operational measures
and contractual agreements. Reliance upon trade secret, rather than patent, protection may cause us to be vulnerable to competitors
who successfully replicate our manufacturing techniques and processes. Additionally, there can be no assurance that others may
not independently develop similar trade secrets or technology or obtain access to our unpatented trade secrets or proprietary technology.
Other companies may have filed patent applications and may have been issued patents involving products or technologies potentially
useful to us or necessary for us to commercialize our products or achieve our business goals. There can be no assurance that we
will be able to obtain licenses to such patents on terms that are acceptable.



We have registered certain
trademarks with the U.S. Patent and Trademark Office in connection with the sale of our products. We own federal trademark registrations
of the following trademarks: ImmuCell, First DefenseÒ, our calf
scours preventive product; Wipe OutÒ Dairy Wipes and the related
design and the trademark “One Step Cow PrepÒ”, our pre-milking
wipe product; MASTiKÒ, our antibiotic susceptibility test; and
Mast OutÒ.



Government Regulation



We believe that we are
in compliance with current regulatory requirements relating to our business and products. The manufacture and sale of animal health
biologicals within the United States is generally regulated by the USDA. We have received USDA and Canadian Food Inspection Agency
approval for First DefenseÒ (our scours preventive product).
Mast OutÒ is regulated by the FDA, Center for Veterinary Medicine,
which regulates veterinary drugs. The manufacture of Wipe OutÒ Dairy
Wipes also is regulated by the FDA, Center for Veterinary Medicine. Comparable agencies exist in foreign countries and foreign
sales of our products will be subject to regulation by such agencies. Many states have laws regulating the production, sale, distribution
or use of biological products, and we may have to obtain approvals from regulatory authorities in states in which we propose to
sell our products. Depending upon the product and its applications, obtaining regulatory approvals may be a relatively brief and
inexpensive procedure or it may involve extensive clinical tests, incurring significant expenses and an approval process of several
years’ duration.



Employees



We currently employ 26 full-time employees
and 3 part-time employees. Approximately 15.05 full-time equivalent employees are engaged in manufacturing operations, 3.95 full-time
equivalent employees in product development activities, 4.75 full-time equivalent employees in finance and administration and 3.75
full-time equivalent employees in sales. At times, manufacturing personnel are also utilized, as needed, in the production of clinical
material for use in product development. All of our employees are required to execute non-disclosure, non-compete and invention
assignment agreements intended to protect our rights in our proprietary products. We are not a party to any collective bargaining
agreement and consider our employee relations to be excellent.



Executive Officers of the Company



Our executive officers
as of March 26, 2012 were as follows:



MICHAEL F. BRIGHAM (Age: 51, Officer
since October 1991, Director since March 1999) was appointed to serve as President and Chief Executive Officer in February 2000,
while maintaining the titles of Treasurer and Secretary, and was appointed to serve as a Director of the Company in March 1999.
He previously had been elected Vice President of the Company in December 1998 and served as Chief Financial Officer since October
1991. He has served as Secretary since December 1995 and as Treasurer since October 1991. Prior to that, he served as Director
of Finance and Administration since originally joining the Company in September 1989. Mr. Brigham joined the Board of Directors
of the United Way of York County in 2011, serving as Treasurer. Mr. Brigham served as the Treasurer of the Board of Trustees of
the Kennebunk Free Library from 2005 to 2011. Prior to joining the Company, he was employed as an audit manager for the public
accounting firm of Ernst & Young. Mr. Brigham earned his Masters in Business Administration from New York University in 1989.



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ImmuCell Corporation



JOSEPH H. CRABB, Ph.D. (Age: 57, Officer
since March 1996, Director since March 2001) was appointed to serve as Chairman of the Board of Directors in June 2009. He was
appointed a Director of the Company in March 2001, having previously served in that capacity during the period from March 1999
until February 2000. Before that, he was elected Vice President of the Company in December 1998, while maintaining the title of
Chief Scientific Officer. He has served as Chief Scientific Officer since September 1998. Prior to that, he served as Vice President
of Research and Development since March 1996. Prior to that, he served as Director of Research and Development and Senior Scientist
since originally joining the Company in November 1988. He is currently a reviewer for several peer-reviewed journals. Concurrent
with his employment, he has served on five study sections at the National Institutes of Health and held three adjunct faculty positions.
Prior to joining the Company in 1988, Dr. Crabb earned his Ph.D. in Biochemistry from Dartmouth Medical School and completed postdoctoral
studies in microbial pathogenesis at Harvard Medical School, where he also served on the faculty.



Public Information



As a reporting company,
we file quarterly and annual reports with the Securities and Exchange Commission on Form 10-Q and Form 10-K. We also file current
reports on Form 8-K, whenever events warrant or require such a filing. The public may read and copy any materials that we file
with the SEC at the SEC’s Public Reference Room at 450 Fifth Street, N.W., Washington, D.C. 20549. The public may obtain
information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet site
that contains reports, proxy and information statements and other information about us that we file electronically with the SEC
at http://www.sec.gov. Our internet address is http://www.immucell.com.



ITEM 1A – RISK FACTORS



This Annual Report on
Form 10-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to:
projections of future financial performance; future compliance with bank debt covenants; the scope and timing of future product
development work and commercialization of our products; future costs of product development efforts; future sources of financial
support for our product development, manufacturing and marketing efforts; the timing and outcome of pending or anticipated applications
for future regulatory approvals; future regulatory requirements relating to our products; future realization of deferred tax assets;
factors that may affect the dairy industry and future demand for our products; the accuracy of our understanding of our distributors’
ordering patterns; anticipated changes in our manufacturing capabilities and efficiencies; the amount and timing of future investments
in facility modifications and production equipment or the availability and cost of alternative manufacturing and/or distribution
resources; the future adequacy of our working capital and the availability of third party financing; future expense ratios; costs
and timing associated with sustaining compliance with cGMP regulations; anticipated competitive and market conditions; and any
other statements that are not historical facts. Forward-looking statements can be identified by the use of words such as “expects”,
“may”, “anticipates”, “intends”, “would”, “could”, “should”,
“will”, “plans”, “believes”, “estimates”, “targets” and similar words
and expressions. In addition, there can be no assurance that future developments affecting us will be those that we anticipate,
especially considering the effects the distress in credit and capital markets will have on our current and prospective customers
and the global economy and the uncertainties surrounding the potential for a prolonged global recession. Such statements involve
risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development,
testing, regulatory approval, production and marketing of our products, competition within our anticipated product markets, the
uncertainties associated with product development, manufacturing reliance upon third parties for products and services, changes
in laws and regulations, decision making by regulatory authorities, currency fluctuations and other risks detailed from time to
time in filings we make with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q, our Annual
Reports on Form 10-K and our Current Reports on Form 8-K. Such statements are based on our current expectations, but actual results
may differ materially due to various factors, including the risk factors summarized below and uncertainties otherwise referred
to in this Annual Report.



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ImmuCell Corporation



Economics of the dairy
industry: The U.S. dairy industry has been facing very difficult economic pressures, which are forcing many dairy producers
out of business. The size (annual average) of the U.S. dairy herd ranged from approximately 9,011,000 to 9,199,000 cows from 1998
to 2007. This annual average jumped to 9,315,000 cows in 2008. The annual average then declined to 9,203,000 in 2009 and further
to 9,119,000 in 2010 before increasing to 9,194,000 in 2011. The size of the milking herd affects the price of milk. Over time,
the impact on the milk supply from a decrease in cows has been offset, in part, by an increase in milk production per cow. While
the number of cows in the U.S. herd and the production of milk per cow directly influence the supply of milk to the market, demand
for milk has been largely influenced by very volatile international demand for milk products. Sales of our products may be influenced
by the prices of milk, milking cows and calves. The Class III milk price is an industry benchmark that reflects the value of product
used to make cheese. The Class III milk price (which is largely out of the direct control of individual dairy producers) is an
important indicator because it defines our customers’ revenue level. The average Class III milk price for 2009 was $11.36,
which represented a 35% decrease from 2008. The average price for 2009 was 36% lower than the average experienced during the two-year
period ended December 31, 2008. For 2010, this price level averaged $14.41, which represented a 27% increase from 2009 but was
well below the 2007 and 2008 levels. This price level averaged $18.37 for 2011, which represents a 27% increase from 2010. This
average price level is higher than the annual average reached in any of the past 30 years. The actual level of milk prices may
be less important than their level relative to costs because recent improvement in milk prices has been offset, in part, by higher
feed costs. One measure of this relationship is known as the milk-feed price ratio, which represents the amount of feed that one
pound of milk can buy. Whenever this ratio meets or exceeds 3.0, it is considered profitable to buy feed and produce milk. For
2009, this ratio averaged 1.78, representing a 12% decrease compared to 2008. For 2010, this ratio averaged 2.26, representing
a 27% increase compared to 2009. For 2011, this ratio averaged approximately 1.88 representing a 17% decrease compared to 2010.
This means that a dairy producer can buy only 1.88 pounds of feed for every pound of milk sold. An increase in feed costs also
has a negative impact on the beef industry. Another indication of the economic condition of the dairy industry is the average price
for animals sold for dairy herd replacement. In 2009, this average price (reported as of January, April, July and October) was
estimated to be approximately $1,385, which was a 29% decrease in comparison to the same period in 2008. This price averaged approximately
$1,330 in 2010, which represented a 4% decrease in comparison to the same period in 2009. This price averaged approximately $1,420
in 2011, which represents a 7% increase in comparison to the same period in 2010. The dairy industry data referred to above is
compiled from USDA databases. Another factor in the demand for our product is the value of bull calves. A decline in the price
of bull calves reduces the return on investment from a dose of First Defense®for bull calves. We are trying
to maintain and grow our sales for use with heifer calves to offset what we assume is a significant decrease in the use of our
product for bull calves. Given our focus on the dairy and beef industries, the financial insecurity of our primary customer base
is a risk to our ability to maintain and grow sales at a profitable level. Further, the loss of farms from which we buy raw material
for First Defense®could make it difficult for us to produce enough inventory until supply agreements are
reached with replacement farms on suitable terms.



Risks associated with
Mast OutÒ funding strategy: There are risks associated with
our decision not to internally fully fund the completion of the development of Mast OutÒ
through to the submission of the administrative NADA to the FDA. A partner may not be willing to step in and fund the completion
of this product development effort on terms acceptable to us. If a partner is not willing to agree to acceptable terms on this
collaboration with us, we will need to re-evaluate alternative strategies in order to gain NADA approval and to support the product
launch. If we do complete the submission, the FDA may not grant approval of this product.



Projections of loss before income taxes
and net loss: After nine consecutive years of reporting net income, we reported a loss before income taxes and a net loss for
the years ended December 31, 2011, 2010, 2009 and 2008, due in large part to our current product development strategy. Our decision
not to fund, with internally generated or borrowed funds, the majority of the remaining expenses to complete the development of
Mast OutÒ may allow us to return to positive net operating income
(before other (expenses) revenues, net and before income taxes). 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. Stronger than
expected sales of First Defense®, for example, could diminish the overall loss. Conversely, weaker than expected
sales of First Defense® could lead to less profits or larger losses. Prior to 2008, we had not publicly disclosed
our projections of future profitability. We did so in 2011, 2010, 2009 and 2008 and have done so again for 2012 to make it clear
to our stockholders that the decision to pursue internal development of Mast Out® entails an important change
in our financial model and strategy that, we believe, is in the long-term interests of the Company and our stockholders.



Concentration of sales:
A large portion of our product sales (52%, 50% and 50% for the years ended December 31, 2011, 2010, and 2009, respectively) was
made to two large distributors. A large portion of our trade accounts receivable (45% as of December 31, 2011 and 48% as of December
31, 2010) was due from these two distributors. These calculations give effect to acquisitions made during the period retroactively
to the beginning of the period. 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. During 2011, 81% of our product sales were made to customers in the
U.S. dairy and beef industries. This compares to 82% during of 2010.



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ImmuCell Corporation



Product development
risks: Our current business growth strategy relies heavily on the development of new products, the most important of which
is Mast OutÒ. The development of new products is subject to financial,
scientific, regulatory and market risks. In particular, the development of Mast OutÒ
requires (and will continue to require) substantial investments by us and by a potential partner, and there is no assurance whether
or when we will obtain all of the clinical and other data necessary to support regulatory approval for this product or secure a
partner on acceptable terms. The market for the treatment of mastitis in dairy cows is highly competitive, and presently is dominated
by large companies such as Pfizer, Merck and Boehringer Ingelheim. There is no assurance that Mast OutÒ
will compete successfully in this market.



Regulatory requirements for Mast OutÒ:
The commercial introduction of Mast OutÒin the United
States will require us to obtain appropriate FDA approval for this product. It presently is uncertain whether or when this approval
will be achieved. We are exposed to additional regulatory compliance risks through the subcontractors that we choose to work with
to produce Mast OutÒ, who also need to satisfy certain regulatory
requirements in order to provide us with the products and services we need. International regulatory approvals would be
required for sales outside of the United States. European regulatory authorities are not expected to approve a product with a zero
milk discard claim, which would remove a significant competitive advantage of Mast OutÒ
in that territory. However, the milk discard period may be shorter for Mast OutÒthan it is for other products on the market.



Risks associated
with USDA regulatory oversight: First Defense®, and modifications and extensions thereto, is subject
to the jurisdiction of the Center for Veterinary Biologics, USDA. Similar regulatory oversight risks exist in territories outside
of the United States where we sell our products.



Regulatory requirements for
First DefenseÒ: First DefenseÒis sold in the United States subject to a product license approval from the USDA, first obtained in 1991. 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 First DefenseÒ
label claims, host animal re-testing is not required as long as periodic laboratory analyses continue to support the stability
of stored Reference Standard. To date, these analyses have demonstrated strong stability. However, if the USDA were not to approve
requalification of the Reference Standard, additional clinical studies could be required to meet regulatory requirements and allow
for continued sales of the product.



Product risks generally: The sale
of our products is subject to financial, efficacy, regulatory and competitive and other market risks. We cannot be sure that we
will be able to maintain the regulatory compliance required to continue selling our products. There is no assurance that we will
continue to achieve market acceptance at a profitable price level or that we can continue to manufacture our products at a sufficient
gross margin.



Product Liability:
The manufacture and sale of certain of our products entails a risk of product liability. Our exposure to product liability is mitigated
to some extent by the fact that our products are principally directed towards the animal health market. We have maintained product
liability insurance in an amount which we believe is reasonable in relation to our potential exposure in this area.



Reliance on sales of
First Defense®: We are heavily reliant on the market acceptance of First Defense®
to generate product sales and fund our operations. Our business would not have been profitable during the nine consecutive years
in the period ended December 31, 2007, and our net losses would have been larger during the four years in the period ended December
31, 2011, without the gross margin that we earned from the sale of First Defense®.



Regulatory requirements
for Wipe OutÒDairy Wipes: While the FDA regulates
the manufacture and sale of Wipe OutÒ, this type of product is
permitted to be sold without a NADA approval, in accordance with the FDA’s Compliance Policy Guide 7125.30 (“Teat Dips
and Udder Washes for Dairy Cows and Goats”). This policy guide could be withdrawn at the FDA’s discretion, in which
case we would likely discontinue sales of the product. The manufacture of Wipe OutÒ
is subject to Part 211 of the cGMP regulations. As such, our operations are subject to inspection by the FDA. We continue to invest
in personnel, facility improvements and new equipment to sustain compliance with cGMP regulations across our entire product line.
In June 2007, we received a Warning Letter from the FDA citing deficiencies in specific areas of the cGMP regulations. We filed
a response to the FDA in June 2007, and we responded to a request for additional information in April 2008. We believe we have
substantially corrected the deficiencies cited, but have received no further communications from the FDA on this subject. We remain
subject to the risk of adverse action by the FDA in this respect.



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ImmuCell Corporation



Uncertainty of market
estimates: Even assuming that Mast OutÒ achieves regulatory
approval in the United States with a zero milk discard requirement, estimating the size of the market for this product is subject
to numerous uncertainties. Some of the uncertainties surrounding our product include the development of the subclinical mastitis
treatment market, coverage of relevant pathogens, selling price and its effect on market penetration, cost of manufacture, integration
of milk from treated cows into cheese starter cultures and market acceptance.



Competition from others: Many of
our competitors are significantly larger and more diversified in the relevant markets, and have substantially greater financial,
marketing, manufacturing and human resources and more extensive product development capabilities than do we, including greater
ability to withstand adverse economic or market conditions and declining revenues and/or profitability. We may not be aware of
other companies that compete with us or intend to compete with us in the future. Our competitive position will be highly influenced
by our ability to attract and retain key scientific and managerial personnel, to develop proprietary technologies and products,
to obtain USDA or FDA approval for new products and to continue to profitably sell our current products. We currently compete on
the basis of product performance, price and distribution capability. We continue to monitor our network of independent distributors
to maintain our competitive position.



Small size; dependence on key employees:
We are a small company with 26 full-time and 3 part-time employees. As such, we rely on certain key employees to support different
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.



Exposure to risks associated
with the financial downturn and global economic crisis: The U.S. economy appears to be coming out of a recession, caused principally
by the housing, credit and financial crises. However, such recent positive indications could prove temporary and further downturn
could occur. The credit markets continue to be very turbulent and uncertain. Sales and financial performance are still down at
many businesses. This extraordinary period of instability facing the U.S. economy and the financial markets has been troubling
for nearly all Americans. Some observers believe that the national unemployment rate is too high, the housing market remains problematic
for the overall U.S. economy, the U.S. has taken on too much national debt and that the equity markets are overvalued. A continued
and prolonged economic downturn could have a corresponding negative effect on our business and operations.



Failure to protect intellectual property:
In some cases, we have chosen (and may choose in the future) not to seek patent protection for certain products or processes. Instead,
we have sought (and may seek in the future) to maintain the confidentiality of any relevant proprietary technology through operational
safeguards and contractual agreements. Reliance upon trade secret, rather than patent, protection may cause us to be vulnerable
to competitors who successfully replicate our manufacturing techniques and processes. Additionally, there can be no assurance that
others may not independently develop similar trade secrets or technology or obtain access to our unpatented trade secrets or proprietary
technology. Other companies may have filed patent applications and may have been issued patents involving products or technologies
potentially useful to us or necessary for us to commercialize our products or achieve our business goals. There can be no assurance
that we will be able to obtain licenses to such patents on terms that are acceptable. There is a risk that competitors could challenge
the claims in patents that have been issued to us.



Our reporting
obligations as a public company are costly: Operating a public company involves substantial costs to comply with reporting
obligations under federal securities laws and the provisions of the Sarbanes-Oxley Act of 2002.



Access to raw materials:
Our policy is to maintain more than one source of supply for the components used to manufacture and test our products. However,
there is a risk that we could have difficulty in efficiently acquiring essential supplies. We are dependent on our manufacturing
operations and facility at 56 Evergreen Drive in Portland, Maine for the production of First DefenseÒ
and Wipe OutÒ Dairy Wipes. The specific antibodies that we purify
for First DefenseÒ and the Nisin we produce by fermentation for
Wipe OutÒ Dairy Wipesare not readily available from other sources.
We expect to be dependent on Plas-Pak and Norbrook for the manufacture of Mast OutÒ
if that product proceeds to commercialization. Any significant damage to or other disruption in the services at these facilities
could adversely affect the production of inventory and result in significant added expenses and loss of sales.



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ImmuCell Corporation



Bovine diseases: The potential for
epidemics of bovine diseases such as Foot and Mouth Disease, Bovine Tuberculosis, Brucellosis and Bovine Spongiform Encephalopathy
(BSE) presents a risk to us and our customers. Documented cases of BSE in the U.S. have led to an overall tightening of regulations
pertaining to ingredients of animal origin, especially bovine. First DefenseÒ
is considered a veterinary medicine rather than a feed ingredient, and it is manufactured from bovine milk and colostrum, which
is not considered a BSE risk material. Future regulatory action to increase protection of the human food supply could affect First
DefenseÒ, although presently we do not anticipate that this will
be the case.



Biological terrorism:
The threat of biological terrorism is a risk to both the economic health of our customers and to our ability to economically acquire
and collect good quality raw material from our contract farms. Any act of widespread bioterrorism against the dairy industry could
adversely affect our operations.



No expectation to pay any dividends
for the foreseeable future:We do not anticipate paying any dividends to our stockholders for the foreseeable future, instead
using cash to fund product development costs. Also, any debt or equity financing we obtain to assist in funding our product development
programs may include terms prohibiting or restricting our paying dividends or repurchasing stock for a lengthy period. Stockholders
must be prepared to rely on sales of their common stock after price appreciation to earn an investment return, which may never
occur. Any determination to pay dividends in the future will be made at the discretion of our Board of Directors and will depend
on our results of operations, financial condition, contractual restrictions, restrictions imposed by applicable laws and other
factors our Board of Directors deems relevant.



Market for common
stock: Our common stock trades on the Nasdaq Stock Market (NASDAQ: ICCC). Our average daily trading volume is lower than the
volume for most other companies, which could result in investors facing difficulty selling their stock for proceeds that they may
expect or desire.



ITEM 2 – DESCRIPTION OF PROPERTY



We own a 27,750 square
foot building at 56 Evergreen Drive in Portland, Maine. We currently use this space for substantially all of our office, laboratory
and manufacturing needs. When we originally purchased this building in 1993, its size was 15,000 square feet, including 5,000 square
feet of unfinished space on the second floor. In 2001, we completed a construction project that added approximately 5,200 square
feet of new manufacturing space on the ground level. The 2001 facility addition also added a storage mezzanine of approximately
4,100 square feet on the second floor. In 2007, we completed a renovation project converting the 5,000 square feet of unfinished
space on the second floor into usable office space. After moving first floor offices into this space, we modified and expanded
the laboratory space on the first floor. As part of the 2007 project, we also added approximately 2,500 square feet of mezzanine
storage space in the second floor. During 2009, we added 600 square feet to the mezzanine storage area and 350 square feet of cold
storage space. We funded these investments with available cash. These investments are an integral part of our strategy to increase
our production capacity and to be compliant with cGMP regulations in our manufacturing operations.



We rent approximately
550 square feet of office and warehouse space in New York State on a short-term basis to support our farm operations.



We maintain property insurance
in amounts that approximate replacement cost and a modest amount of business interruption insurance. We also maintain access to
certain animals, primarily cows, through contractual relationships with commercial dairy farms.



ITEM 3 – LEGAL PROCEEDINGS



None



ITEM 4 – MINE SAFETY DISCLOSURES



None



13







ImmuCell Corporation



PART II



ITEM 5 – MARKET FOR COMMON EQUITY,
RELATED STOCKHOLDER MATTERS AND PURCHASES OF EQUITY SECURITIES



Our common stock trades
on the NASDAQ Capital Market tier of the NASDAQ Stock Market under the symbol ICCC. No dividends have been declared or paid on
the common stock since its inception, and we do not contemplate the payment of cash dividends in the foreseeable future. The following
table sets forth the high and low sales price information for our common stock as reported by the NASDAQ Stock Market during the
period January 1, 2010 through December 31, 2011:



|     |  | 2011               |      |  | 2010               |  
|---- |  | ------------------ | ---- |  | ------------------ | -
|     |  | Three Months Ended |      |  | Three Months Ended |  
|     |  | March 31           |      |  | June 30            |  
|High |  | $                  | 3.80 |  |                    | $
|Low  |  | $                  | 2.91 |  |                    | $



As of March 26, 2012,
we had 8,000,000 common shares authorized and 3,019,034 common shares outstanding, and there were approximately 1,000 shareholders
of record. The last sales price of our common stock on March 21, 2012 was $4.70 per share as quoted on the NASDAQ Stock Market.



Equity Compensation Plan Information



The table below summarizes
the common stock reserved for issuance upon the exercise of stock options outstanding as of December 31, 2011 or that could be
granted in the future:



|                                                       |  | Number of shares to be issued upon exercise of outstanding options |         |  | Weighted-average exercise price of outstanding options |   |      | Number of shares remaining available for future issuance under stock-based compensation plans (excluding shares reflected in first column of this table) | 
|------------------------------------------------------ |  | ------------------------------------------------------------------ | ------- |  | ------------------------------------------------------ | - | ---- | -------------------------------------------------------------------------------------------------------------------------------------------------------- | 
|Equity compensation plans approved by stockholders     |  |                                                                    | 236,000 |  |                                                        | $ | 3.19 |                                                                                                                                                          | 
|                                                       |  |                                                                    |         |  |                                                        |   |      |                                                                                                                                                          | 
|Equity compensation plans not approved by stockholders |  |                                                                    | —       |  |                                                        |   | —    |                                                                                                                                                          | 
|                                                       |  |                                                                    |         |  |                                                        |   |      |                                                                                                                                                          | 
|Total                                                  |  |                                                                    | 236,000 |  |                                                        | $ | 3.19 |                                                                                                                                                          | 



ITEM 6 – SELECTED FINANCIAL DATA



The selected financial
data set forth below has been derived from our audited financial statements. The information should be read in conjunction with
the audited financial statements and related notes appearing elsewhere in this Form 10-K and in earlier reports filed on Form 10-KSB
or 10-K (in thousands, except for per share amounts).



|                                    |  | Year Ended December 31, |      
|----------------------------------- |  | ----------------------- | -----
|                                    |  | 2011                    |      
|Statement of Operations Data:       |  |                         |      
|Product sales                       |  | $                       | 5,111
|Gross margin                        |  |                         | 2,814
|Product development expenses        |  |                         | 1,720
|Selling and administrative expenses |  |                         | 1,726
|Net operating (loss) income         |  |                         | (633 
|Other (expenses) revenues, net      |  |                         | (64  
|(Loss) income before income taxes   |  |                         | (697 
|Net (loss) income                   |  | $                       | (410 



14







ImmuCell Corporation



|                                                     |  | Year Ended December 31, |      
|---------------------------------------------------- |  | ----------------------- | -----
|                                                     |  | 2011                    |      
|Per Common Share:                                    |  |                         |      
|Basic net (loss) income                              |  | $                       | (0.14
|Diluted net (loss) income                            |  | $                       | (0.14
|Cash dividend                                        |  |                         | —    
|                                                     |  |                         |      
|Statement of Cash Flows Data:                        |  |                         |      
|Net cash (used for) provided by operating activities |  | $                       | (37  



|                                                  |  | As of December 31, |       
|------------------------------------------------- |  | ------------------ | ------
|                                                  |  | 2011               |       
|Balance Sheet Data:                               |  |                    |       
|Cash, cash equivalents and short-term investments |  | $                  | 4,960 
|Total assets                                      |  |                    | 10,991
|Current liabilities                               |  |                    | 635   
|Net working capital                               |  |                    | 6,516 
|Long-term liabilities                             |  |                    | 1,336 
|Stockholders’ equity                              |  | $                  | 9,020 
|                                                  |  |                    |       
|Per Outstanding Common share:                     |  |                    |       
|Cash, cash equivalents and short-term investments |  | $                  | 1.65  
|Stockholders’ equity                              |  | $                  | 3.00  



ITEM 7 – MANAGEMENT’S DISCUSSION
AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS



Results of Operations



Fiscal Year 2011 Compared to Fiscal
Year 2010



Product Sales



Product sales for the year ended December
31, 2011 increased by 17%, or $725,000, to $5,111,000 from $4,386,000 in 2010. Domestic product sales increased by 16%, or $560,000,
during the year ended December 31, 2011, and international sales increased by 21%, or $165,000, in comparison to 2010. For the
three-month period ended December 31, 2011, product sales increased by 16%, or $181,000, in comparison to the three-month period
ended December 31, 2010. We believe that sales of our products were influenced by the increased price of milk, cows and calves
and partially offset by the increased cost of feed.



Competition for resources
that dairy producers allocate to their calf enterprises has been increased by the many new products that have been introduced to
the calf market. While milk prices have improved recently, much of this gain has been offset by increases in the cost of feed.
Even in this challenging market, our lead product, First DefenseÒ,
continues to benefit from wide acceptance by dairy and beef producers as an effective tool to prevent bovine enteritis (scours)
in newborn calves. During the fourth quarter of 2011, we sold our 11,000,000th dose of First DefenseÒ. The third quarter of 2011 marked the 20th anniversary of the original USDA approval of this product in 1991.
We believe that these milestones demonstrate the value of our technology and the long-term market acceptance of our product. It
is our production and customer service objective to ship orders within one day of receipt. We have been operating in accordance
with this objective since the third quarter of 2009. Sales of First DefenseÒ
increased by 21% during the year ended December 31, 2011 in comparison to 2010. Domestic sales of First DefenseÒ
increased by 20%, and international sales increased by 25%. Sales of First DefenseÒ
are normally seasonal, with higher sales expected during the first quarter. We have been experiencing consistently positive sales
growth of First DefenseÒ since the fourth quarter
of 2010, as demonstrated below:



15







ImmuCell Corporation



21%: Fiscal Year 2011 over Fiscal Year 2010

7%: Fourth Quarter 2011 over Fourth Quarter
2010

22%: Third Quarter 2011 over Third Quarter
2010

37%: Second Quarter 2011 over Second Quarter
2010

21%: First Quarter 2011 over First Quarter
2010

13%: Fourth Quarter 2010 over Fourth Quarter
2009



We believe that the growth
in sales of First DefenseÒ may reflect, at least in part, the
success of our strategic decision to invest in additional sales and marketing efforts. We launched a communications campaign at
the end of 2010 that is highlighting how the unique features of First DefenseÒ
provide a dependable return on investment for producers. Effective for 2011 and for 2012, and renewable for 2013 and 2014 if certain
sales growth objectives are met, we entered into a sales and marketing collaboration with AgriLabs, under which the AgriLabs sales
and marketing teams are working with us to expand market demand for First DefenseÒ.



We are investigating additional
opportunities to commercialize our whey protein purification technologies in the nutritional and feed supplement markets in different
formats not regulated by the USDA. First Defense TechnologyTM is a unique whey protein concentrate that is purified
utilizing our proprietary whey protein processing methods. It does not carry the claims of our USDA-licensed product. Through our
First Defense TechnologyTM, we are selling whey concentrate globulin proteins in different formats. During the
first quarter of 2011, we initiated sales of our First Defense TechnologyTM in a bulk powder format (no capsule),
which is delivered with a scoop. During the first quarter of 2012, we initiated a limited launch of a tube delivery format of our
First Defense TechnologyTMin a gel solution. Through two collaborations, we are working to expand sales of our
First Defense TechnologyTM by accessing the U.S. feed market. During the first quarter of 2011, AgriLabs launched
commercial sales of their product, Colostrx®, a colostrum supplement with First Defense TechnologyTM Inside.
During the fourth quarter of 2011, Milk Products, LLC launched commercial sales of their product, Ultra StartÒ
150 Plus, a colostrum replacer with First Defense TechnologyTM Inside.



Sales of Wipe OutÒ
Dairy Wipes decreased by 18% during the year ended December 31, 2011 in comparison to 2010. We believe that sales growth potential
for Wipe OutÒ Dairy Wipes is limited because most of our sales
of this product tend to be to smaller dairies that are under continued financial pressures. Such pressures are forcing many small
dairy producers out of business. While our product is a high quality tool, there are less expensive ways to sanitize a cow prior
to milking, and many producers opt for a less expensive solution. We are competing aggressively on selling price to earn new business
against less expensive products and alternative teat sanitizing methods.



The other products we sell primarily into
the dairy industry aggregated approximately 3% of product sales during 2011 and 2010. Sales of these products were 28% higher in
2011 than the level of sales achieved in 2010. The other products we sell outside of the dairy and beef industries, principally
IsolateTM (formerly known as Crypto-Scan®), aggregated 2% and 3% of product sales during the years ended
December 31, 2011 and 2010, respectively. Sales of our bulk reagents for use in a drinking water test sold by others decreased
by 21% during the year ended December 31, 2011 in comparison to 2010. During 2011, these sales were recorded during the fourth
quarter. During 2010, these sales were recorded during the second quarter. Our animal health sales (total product sales less sales
of the water diagnostic reagents) increased by 18% during the year ended December 31, 2011 in comparison to 2010. This comparison
more accurately reflects the growth of our core animal health business.



We generally held our
product selling prices without increase during the seven year period ended December 31, 2007. During the first quarter of 2008,
we implemented a modest increase to the selling price of First Defense®. We have implemented no significant
price increases since then believing that we could benefit more from higher unit sales than through a higher average selling price
per unit.



16







ImmuCell Corporation



Gross Margin



Changes in the gross margin on product
sales are summarized in the following table for the respective periods (in thousands, except for percentages):



|                         |  | Years Ended December 31, |       |   | Increase |  
|------------------------ |  | ------------------------ | ----- | - | -------- | -
|                         |  | 2011                     |       |   | 2010     |  
|Gross margin             |  | $                        | 2,814 |   |          | $
|Percent of product sales |  |                          | 55    | % |          |  



The gross margin as a percentage of product
sales was 55% and 52% during the years ended December 31, 2011 and 2010, respectively. This compares to gross margin percentages
of 53% and 45% for the years ended December 31, 2009 and 2008, respectively. We experienced an unusually low gross margin percentage
during 2008 in comparison to those achieved in other periods. Our current annual target is to maintain the gross margin percentage
at approximately 50%. A number of factors account for the variability in our costs. We expect some fluctuations in gross margin
percentages from quarter to quarter. The gross margin on First DefenseÒ
is affected by biological yields from our raw material, which do fluctuate over time. More generally, costs for production of First
DefenseÒ and Wipe OutÒ
Dairy Wipes have increased due to increased labor costs and expenses associated with our efforts to sustain compliance with
cGMP regulations in our production processes. Like most manufacturers in the U.S., we have been experiencing increases in the cost
of raw materials that we purchase. We have been able to minimize the impact of these cost increases by implementing yield improvements.
Product mix also affects gross margin in that we earn a higher gross margin on First DefenseÒ
and a lower gross margin on Wipe OutÒ Dairy Wipes. Our inventory
balance increased by 4%, or $65,000, to $1,666,000 at December 31, 2011 from $1,601,000 at December 31, 2010. This level of investment
was made in both periods to help prevent a potential back log of orders. We have not experienced a back log of orders since the
third quarter of 2009.



Product Development Expenses



Product development
expenses increased by 15%, or $227,000, to $1,720,000 during the year ended December 31, 2011, as compared to $1,493,000 during
2010. We expected higher product development expenses during the year ended December 31, 2011. Product development expenses aggregated
34% of product sales in 2011 and 2010. The majority of our product development budget from 2000 through 2011 has been focused on
the development of Mast OutÒ. Going forward, we expect to reduce
our product development expenses, which expenses will continue to be focused on Mast OutÒ
and other improvements, extensions or additions to our First DefenseÒ
product line. The other improvements, extensions, or additions to our current product line include the potential to prevent scours
in calves caused by pathogens other than those within the current First DefenseÒ
disease claims (E. coli K99 and coronavirus) such as rotavirus. We also remain interested in acquiring other new products
and technologies that fit with our sales focus on the dairy and beef industries. We are currently seeking funding from a partner
to complete the development of Mast OutÒ and to support the manufacturing,
sales and marketing efforts.



Sales and Marketing
Expenses



Sales and marketing expenses
increased by approximately 34%, or $219,000, to $870,000 in 2011, increasing to 17% of product sales in 2011 from 15% in 2010.
We continue to leverage the efforts of our small sales force through veterinary distributors. These expenses have increased due
principally to a strategic decision to invest more to support First DefenseÒsales and to prepare for a market launch of Mast OutÒ.
This investment may have created, at least in part, our recent increase in product sales. Our current budgetary objective in 2012
is to maintain the ratio of product selling expenses to product sales below 20% on an annual basis.



17







ImmuCell Corporation



Administrative Expenses



Administrative expenses
increased by approximately 1%, or $8,000, to $857,000 during the year ended December 31, 2011 as compared to $849,000 during 2010.
We strive to be efficient with these expenses while funding costs associated with complying with the Sarbanes-Oxley Act of 2002
and other costs associated with being a publicly-held company. At this stage in our development, we have limited our investment
in investor relations spending. We provide a full disclosure of the status of our business and financial condition in three quarterly
reports and one annual report each year. Additional information about our business is available in our annual Proxy Statement.
All of these reports are filed with the SEC and are available on-line or upon request to the Company. Presently, our financial
and time resources are committed principally to managing our commercial business and developing Mast OutÒ.
Our Board of Directors is very involved with and supportive of this resource allocation. While this strategy of providing cost-effective
investor relations through our SEC reporting is subject to change, we believe that this focus currently is in the best long-term
interest of all stockholders.



Other (Expenses) Revenues,
Net



Interest income decreased
by approximately 38%, or $10,000, to $15,000 in 2011 in comparison to 2010 due principally to a decrease in interest rates. Interest
expense aggregated $81,000 and $22,000 during 2011 and 2010, respectively.



Loss Before Income
Taxes and Net Loss



Our loss before income
taxes of $697,000 during the year ended December 31, 2011 compares to a loss before income taxes of $683,000 during 2010. We recorded
income tax benefits of 41% and 44% of the losses before income taxes during the years ended December 31, 2011 and 2010, respectively.
Our net loss of $410,000, or $0.14 per share, during the year ended December 31, 2011 compares to a net loss of $385,000, or $0.13
per share, during 2010.



Fiscal Year 2010 Compared to Fiscal
Year 2009



Product Sales



Product sales for the year ended December
31, 2010 decreased by 3%, or $120,000, to $4,386,000 from $4,506,000 in 2009. Domestic product sales increased by 2%, or $76,000,
during the year ended December 31, 2010, while international sales decreased by 20%, or $196,000, in comparison to 2009. For the
three-month period ended December 31, 2010, product sales increased by 9%, or $89,000, in comparison to the three-month period
ended December 31, 2009. We expect some sales volatility in our international sales. We believe that sales of our products were
influenced by the price of milk, cows and calves and by the cost of feed.



Sales of First DefenseÒ
decreased by 2% during the year ended December 31, 2010 in comparison to 2009. Domestic sales of First DefenseÒ
increased by 2%, but international sales decreased by 18%. Sales of First DefenseÒ
increased by 13% during the three-month period ended December 31, 2010 in comparison to the three-month period ended December 31,
2009. Sales of First DefenseÒ are normally seasonal, with higher
sales expected during the first quarter. First DefenseÒcontinued
to benefit in 2010 from wide acceptance by dairy and beef producers as an effective tool to prevent bovine enteritis (calf scours).



Sales of Wipe OutÒ
Dairy Wipes increased by 10% during the year ended December 31, 2010 in comparison to 2009. We believe that sales growth potential
for Wipe OutÒ Dairy Wipes is limited because most of our sales
of this product tend to be to smaller dairies that are under continued financial pressures that are forcing many small dairy producers
out of business and because, while our product is a high quality tool, there are less expensive ways to sanitize a cow prior to
milking.



The other products we sell primarily into
the dairy industry decreased to 3% of product sales during the year ended December 31, 2010 compared to 4% of product sales during
2009. The other products we sell outside of the dairy and beef industries, principally IsolateTM (formerly known as Crypto-Scan®),
aggregated 3% of product sales during the years ended December 31, 2010 and 2009.



We generally held our
product selling prices without increase during the seven year period ended December 31, 2007. During the first quarter of 2008,
we implemented a modest increase to the selling price of First Defense®. We have implemented no significant
price increases since then.



18







ImmuCell Corporation



Gross Margin



Changes in the gross margin on product
sales are summarized in the following table for the respective periods (in thousands, except for percentages):



|                         |  | Years Ended December 31, |       |   | Decrease |  
|------------------------ |  | ------------------------ | ----- | - | -------- | -
|                         |  | 2010                     |       |   | 2009     |  
|Gross margin             |  | $                        | 2,302 |   |          | $
|Percent of product sales |  |                          | 52    | % |          |  



The gross margin as a percentage of product
sales was 52% and 53% during the years ended December 31, 2010 and 2009, respectively. This compares to gross margin percentages
of 45% and 52% for the years ended December 31, 2008 and 2007, respectively. We experienced an unusually low gross margin percentage
during 2008 in comparison to those achieved in other periods. Our current annual target is to maintain the gross margin percentage
at approximately 50%. A number of factors account for the variability in our costs. We expect some fluctuations in gross margin
percentages from quarter to quarter. The gross margin on First DefenseÒ
is affected by biological yields from our raw material, which do fluctuate over time. More generally, costs for production of First
DefenseÒ and Wipe OutÒ
Dairy Wipes have increased due to increased labor costs and expenses associated with our efforts to sustain compliance with
cGMP regulations in our production processes. Like most manufacturers in the U.S., we have been experiencing increases in the cost
of raw materials that we purchase. We have been able to minimize the impact of these cost increases by implementing yield improvements.
Product mix also affects gross margin in that we earn a higher gross margin on First DefenseÒ
and a lower gross margin on Wipe OutÒ Dairy Wipes. Our inventory
balance increased by 47%, or $514,000, to $1,601,000 at December 31, 2010 from $1,087,000 at December 31, 2009. This investment
was made to help prevent a potential back log of orders. We have not experienced a back log of orders since the third quarter of
2009. We have not implemented significant increases to our selling prices, believing that we could benefit more from higher unit
sales volume than through a higher average selling price per unit.



Product Development Expenses



Product development expenses
decreased by 9%, or $152,000, to $1,493,000 during the year ended December 31, 2010, as compared to $1,645,000 during 2009. We
expect higher product development expenses during the year ending December 31, 2011. If a partner agrees to fund the completion
of the Mast OutÒ product development effort, these expenses would
be expected to increase even higher, but only if they are off set, in part, by the funds expected to be received from a potential
strategic collaboration. Product development expenses aggregated 34% and 37% of product sales in 2010 and 2009, respectively. The
majority of our product development budget from 2000 through 2010 has been focused on the development of Mast OutÒ.
Going forward, we expect to focus our product development expenses on Mast OutÒ
and other improvements, extensions or additions to our First DefenseÒ
product line. The other improvements, extensions, or additions to our current product line include the potential to prevent scours
in calves caused by pathogens other than those within the current First DefenseÒ
disease claims (E. coli K99 and coronavirus) such as rotavirus. We also remain interested in acquiring other new products
and technologies that fit with our sales focus on the dairy and beef industries.



Administrative Expenses



Administrative expenses
decreased by approximately 3%, or $23,000, to $849,000 during the year ended December 31, 2010 as compared to $873,000 during 2009.
We strive to be efficient with these expenses while funding costs associated with complying with the Sarbanes-Oxley Act of 2002
and other costs associated with being a publicly-held company. At this stage in our development, we have limited our investment
in investor relations spending. We provide a full disclosure of the status of our business and financial condition in three quarterly
reports and one annual report each year. Additional information about our business is available in our annual Proxy Statement.
All of these reports are filed with the SEC and are available on-line or upon request to the Company. Presently, our financial
and time resources are committed principally to managing our commercial business and developing Mast OutÒ.
Our Board of Directors is very involved with and supportive of this resource allocation. While this strategy of providing cost-effective
investor relations through our SEC reporting is subject to change, we believe that this focus currently is in the best long-term
interest of all stockholders.



19







ImmuCell Corporation



Product Selling Expenses



Product selling expenses
increased by approximately 58%, or $240,000, to $651,000 in 2010, increasing to 15% of product sales in 2010 from 9% in 2009. We
continue to leverage the efforts of our small sales force through veterinary distributors. These expenses have increased due principally
to a strategic decision to invest more to support First DefenseÒsales and to prepare for a market launch of Mast OutÒ.
Our objective in 2011 was to maintain the ratio of product selling expenses to product sales below 20% on an annual basis.



Other Revenues (Expenses),
Net



Interest income decreased
by approximately 74%, or $71,000, to $25,000 in 2010 in comparison to 2009 due principally to a decrease in interest rates. We
did not incur interest expense during 2009 or 2008. Interest expense during 2010 aggregated $22,000.



Loss Before Income
Taxes and Net Loss



Our loss before income
taxes of $683,000 during the year ended December 31, 2010 compares to a loss before income taxes of $429,000 during the year ended
December 31, 2009. We recorded income tax benefits of 44% and 49% of the losses before income taxes during the years ended December
31, 2010 and 2009, respectively. Our net loss of $385,000, or $0.13 per share, during the year ended December 31, 2010 compares
to a net loss of $216,000, or $0.07 per share, during the year ended December 31, 2009.



Liquidity and Capital Resources



Since 1999, our strategy
has been focused on selling and developing products that improve animal health and productivity in the dairy and beef industries.
These product opportunities are generally less expensive to develop than the human health product opportunities that we had worked
on during the 1990’s. We funded most of our product development expenses principally from product sales and were profitable
for each of the nine years in the period ended December 31, 2007. During the nine years of profitability from 1999 through 2007,
our cumulative investment in product development expenses of $9,894,000 was supported, in small part, by $975,000 in grant awards.
The investment of an additional $6,604,000 in product development expenses during 2011, 2010, 2009 and 2008 brings our cumulative
investment to $16,498,000 during the thirteen-year period ended December 31, 2011. We may, on occasion, seek additional research
grant support as a means of leveraging the funds that we are able to spend developing new products.



Our strategic decision to continue developing
Mast OutÒ after the product rights were returned to us in 2007
has caused us to increase our spending on product development expenses that were previously funded by Pfizer from late 2004 to
mid-2007. After the nine consecutive years of profitability that we recorded during the years ended December 31, 1999 to December
31, 2007, we incurred net losses of $410,000, $385,000, $216,000, and $469,000 during the years ended December 31, 2011, 2010,
2009, and 2008, respectively. As we reduce product development spending on Mast OutÒ,
we expect to return to profitable operations. We have not invested the time and resources to carefully make an exact projection
about the timing or extent of our anticipated return to profitability. We believe that the three key indicators that investors
should watch going forward will be the gross margin on our product sales, our net operating income (loss) and our net income (loss).



We estimate that it will require approximately
$13,000,000 to complete the development of Mast OutÒand
bring the product to market, sales of which are subject to FDA approval. This budget is comprised of costs primarily related to
the manufacture of commercial inventory. We are seeking to finance this investment with a combination of available cash, partner
funding and debt. Outside funding is required to pay for the larger financial commitments required for manufacturing scale-up and
preparation of full-scale validation batches of Mast OutÒ. By
the second quarter of 2011, we had advanced the product development effort internally to the point where we could begin earnest
negotiations with prospective partners. All anticipated initial discussions are now complete, and some prospective partners are
conducting their due diligence. It is difficult to predict when or if this partnering effort will be successful. Although these
partnering discussions are taking longer than we would like or had initially anticipated, we believe that the commercial prospects
for Mast OutÒ warrant our continued efforts and patience with
the process.



20







ImmuCell Corporation



We had approximately $4,960,000
in available cash and short-term investments as of December 31, 2011. We are using some of this cash to fund product development,
principally Mast Out®. We continue to look for new product acquisition opportunities that would have a strategic
fit with the products that we currently sell. The table below summarizes the changes in selected, key balance sheet items (in thousands,
except for percentages):



|                                                  |  | Balance at December 31, |        |  | Increase (Decrease) |  
|------------------------------------------------- |  | ----------------------- | ------ |  | ------------------- | -
|                                                  |  | 2011                    |        |  | 2010                |  
|Cash, cash equivalents and short-term investments |  | $                       | 4,960  |  |                     | $
|Net working capital                               |  |                         | 6,516  |  |                     |  
|Total Assets                                      |  |                         | 10,991 |  |                     |  
|Stockholders’ equity                              |  | $                       | 9,020  |  |                     | $



Cash, cash equivalents
and short-term investments increased by 7%, or $334,000, to $4,960,000 at December 31, 2011 from $4,626,000 at December 31, 2010.
Net cash used for operating activities amounted to $37,000 during the year ended December 31, 2011 as compared to net cash used
for operating activities of $809,000 during the year ended December 31, 2010. Capital investments of $244,000 during 2011 compared
to capital investments of $117,000 during 2010. Net working capital increased by 1%, or $75,000, to $6,516,000 at December 31,
2011 from $6,441,000 at December 31, 2010. Proceeds from bank debt received during 2011 aggregated $455,000, net of debt repayments
made during 2011. Proceeds from bank debt received during 2010 aggregated $986,000, net of debt repayments made during 2010. Total
assets increased by 2%, or $240,000, to $10,991,000 at December 31, 2011 from $10,751,000 at December 31, 2010. Stockholders' equity
decreased by 3%, or $262,000, to $9,020,000 at December 31, 2011 from $9,282,000 at December 31, 2010. We believe that we have
sufficient capital resources to meet our working capital requirements and to finance our ongoing business operators during at least
the next twelve months. We expect to return to positive net operating income (before other revenues (expenses), net and income
taxes) during 2012.



During the third quarter of 2010, we agreed
to terms of certain credit facilities with TD Bank, N.A. aggregating up to approximately $2,100,000, which are secured by substantially
all of our assets. These credit facilities are comprised of a $1,000,000 ten-year mortgage loan, a $600,000 fifty-four month note
and a $500,000 line of credit. Proceeds from the $1,000,000 mortgage loan were received during the third quarter of 2010. Proceeds
from the $600,000 note were received during the first quarter of 2011. The $500,000 line of credit is available as needed. We believe
that this debt financing (together with available cash and gross margin from ongoing product sales) provides us with sufficient
funding to finance our working capital requirements while completing the first submissions to the FDA of all Technical Sections
pertaining to Mast OutÒ. We chose debt financing because we believe
that in this market environment, the option to generate funds through the sale of equity securities at an acceptable level of stockholder
dilution is very unlikely.



As part of our sustained investment in
compliance with cGMP regulations across our product lines and as we make other process improvements, we are investing in personnel,
equipment and facility modifications to increase the efficiency and quality of our operations. In 2008, our Board of Directors
authorized an investment of approximately $1,314,000 for capital expenditures (facility modifications and production equipment).
As of January 1, 2012, we had remaining available authorization to spend up to $234,000 on capital expenditures, net of $1,230,000
in investments made from January 1, 2008 through December 31, 2011, which amount includes a $150,000 increase to this authorized
limit that was approved by our Board of Directors during the fourth quarter of 2011.



Off-Balance Sheet Arrangements



None



21







ImmuCell Corporation



Critical Accounting Policies



The financial statements
are presented on the basis of accounting principles that are generally accepted in the U.S. All professional accounting standards
that were effective and applicable to us as of December 31, 2011 have been taken into consideration in preparing the financial
statements. The preparation of financial statements requires that we make estimates and judgments that affect the reported amounts
of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis,
we evaluate our estimates, including those related to revenue recognition, income taxes, contingencies and the useful lives and
carrying values of intangible and long lived assets. We base our estimates on historical experience and on various other assumptions
that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates
under different assumptions or conditions. We have chosen to highlight certain policies that we consider critical to the operations
of the business and understanding our financial statements.



We recognize revenue in
accordance with Staff Accounting Bulletin (SAB) No. 104, “Revenue Recognition”, which supersedes SAB No. 101, “Revenue
Recognition in Financial Statements”. SAB No. 104 requires that four criteria are met before revenue is recognized. These
include i) persuasive evidence that an arrangement exists, ii) delivery has occurred or services have been rendered, iii) the seller’s
price is fixed and determinable and iv) collectibility is reasonably assured. We recognize revenue at the time of shipment (including
to distributors) for substantially all products, as title and risk of loss pass to the customer on delivery to the common carrier
after concluding that collectibility is reasonably assured. We recognize service revenue at the time the service is performed.
Royalty income is recorded on the accrual basis based on sales as reported to us by our licensee pursuant to the terms of the agreement.
All research and development costs and patent costs are expensed as incurred.



Inventory includes raw materials, work-in-process
and finished goods and are recorded at the lower of standard cost which approximates cost on the first-in, first-out method or
market (net realizable value). Work-in-process and finished goods inventories include materials, labor and manufacturing overhead.



ITEM 7A – QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK



We believe that neither
inflation nor interest rates nor currency exchange rates have had a significant effect on our revenues and expenses. However, future
increases in inflation or interest rates or the value of the U.S. dollar could affect our customers and the demand for our products.
We hedged our interest rate exposure to a $1,000,000 mortgage with an interest rate swap agreement that effectively converted a
floating interest rate to the fixed rate of 6.04%. The interest rate on our $600,000 note is variable. If the London Interbank
Offered Rate plus 3.25% exceeds 4.25%, our interest payments will increase over the current amount. We hope to increase the level
of our future sales of products outside the United States. The cost of our products to international customers could be affected
by currency fluctuations. The decline of the U.S. dollar against other currencies could make our products less expensive to international
customers. We do not anticipate that currency fluctuations will significantly affect our sales or the cost of operations.



ITEM 8 –FINANCIAL STATEMENTS



Our financial statements,
together with the notes thereto and the report of the independent registered public accounting firm thereon, are set forth on Pages
F-1 through F-18 at the end of this report. The index to these financial statements is as follows:



|Report of Baker Newman & Noyes, LLC, Independent Registered Public Accounting Firm      | F-1        
|--------------------------------------------------------------------------------------- | -----------
|Balance Sheets as of December 31, 2011 and 2010                                         | F-2        
|Statements of Operations for the years ended December 31, 2011, 2010 and 2009           | F-3        
|Statements of Stockholders’ Equity for the years ended December 31, 2009, 2010 and 2011 | F-4        
|Statements of Cash Flows for the years ended December 31, 2011, 2010 and 2009           | F-5        
|Notes to Financial Statements                                                           | F-6 to F-18



22







ImmuCell Corporation



ITEM 9 – CHANGES IN AND DISAGREEMENTS
WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE



None



ITEM 9A – CONTROLS AND PROCEDURES



Disclosure Controls
and Procedures. Our management, with the participation of the individual who serves as our principal executive and principal
financial officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2011. Based on this
evaluation, that officer concluded that our disclosure controls and procedures were effective as of that date. Disclosure controls
and procedures are designed to ensure that information required to be disclosed by us in the reports that we file or submit under
the Exchange Act (i) is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules
and forms and (ii) is accumulated and communicated to our management, including our principal executive and principal financial
officer, as appropriate to allow timely decisions regarding required disclosure.



Management’s
Annual Report on Internal Control Over Financial Reporting.The management of the Company is responsible for establishing and
maintaining adequate internal control over financial reporting. The Company’s internal control over financial reporting is
designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles.



Management conducted an
evaluation of the effectiveness of the internal controls over financial reporting based on the framework in Internal Control -
Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. This evaluation included a
review of the documentation of controls, evaluation of the design effectiveness of controls, testing the operating effectiveness
of the controls and a conclusion on this evaluation. Because of its inherent limitations, internal control over financial reporting
may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance
with respect to financial statement preparation and presentation. Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.



Management assessed the effectiveness of
the Company’s internal control over financial reporting as of December 31, 2011. Based on management’s assessment and
those criteria, management believes that the internal control over financial reporting as of December 31, 2011 was effective.



This Annual Report does
not include an attestation report of the Company’s independent registered public accounting firm regarding internal control
over financial reporting. Management’s internal control report was not subject to attestation by the Company’s independent
registered public accounting firm pursuant to rules of the Securities and Exchange Commission that permit the Company to provide
only management’s report.



Changes in Internal
Controls over Financial Reporting. There was no change in our internal control over financial reporting that occurred during
our last fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial
reporting.



ITEM 9B – OTHER INFORMATION



None



23







ImmuCell Corporation



PART III



ITEM 10 –DIRECTORS, EXECUTIVE
OFFICERS AND CORPORATE GOVERNANCE



Information with respect
to our directors is incorporated herein by reference to the section of our 2012 Proxy Statement titled “Election of the Board
of Directors”, which we intend to file with the Securities and Exchange Commission within 120 days after December 31, 2011.
The information required by this item with respect to our executive officers is contained in Item 1 of Part I of this Annual Report
on Form 10-K under the heading “Executive Officers of the Company”. There is no family relationship between any director,
executive officer, or person nominated or chosen by the Company to become a director or executive officer.



ITEM 11 – EXECUTIVE COMPENSATION



Information regarding
cash compensation paid to our executive officers is incorporated herein by reference to the section of our 2012 Proxy Statement
titled “Executive Officer Compensation”, which we intend to file with the Securities and Exchange Commission within
120 days after December 31, 2011.



ITEM 12 –SECURITY OWNERSHIP
OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS



Information regarding
ownership of our common stock by certain owners and management is incorporated herein by reference to the section of our 2012 Proxy
Statement titled “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters”,
which we intend to file with the Securities and Exchange Commission within 120 days after December 31, 2011.



ITEM 13 –CERTAIN RELATIONSHIPS
AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE



Information regarding
certain relationships and related transactions is incorporated herein by reference to the section of our 2012 Proxy Statement titled
“Certain Relationships and Related Transactions and Director Independence”, which we intend to file with the Securities
and Exchange Commission within 120 days after December 31, 2011.



ITEM 14 – PRINCIPAL ACCOUNTING FEES
AND SERVICES



Information regarding
our principal accountant fees and services is incorporated by reference to the section of our 2012 Proxy Statement titled “Principal
Accounting Fees and Services”, which we intend to file with the Securities and Exchange Commission within 120 days after
December 31, 2011.



ITEM 15 – EXHIBITS AND FINANCIAL
STATEMENT SCHEDULES



| | 3.1 | Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3.1 of the Company’s
1987 Registration Statement No. 33-12722 on Form S-1 as filed with the Commission).
| | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 3.2 | Certificate of Amendment to the Company’s Certificate of Incorporation effective July 23, 1990
(incorporated by reference to Exhibit 3.2 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2008).
| | --- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 3.3 | Certificate of Amendment to the Company’s Certificate of Incorporation effective August 24,
1992 (incorporated by reference to Exhibit 3.3 of the Company’s Annual Report on Form 10-K for the year ended December 31,
2008).
| | --- | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 3.4 | Bylaws of the Company as amended (incorporated by reference to Exhibit 3.4 of the Company’s
Annual Report on Form 10-K for the year ended December 31, 2008).
| | --- | -------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 4.1 | Rights Agreement dated as of September 5, 1995, between the Company and American Stock Transfer and
Trust Co., as Rights Agent, which includes as Exhibit A thereto the form of Right Certificate and as Exhibit B thereto the Summary
of Rights to Purchase Common Stock (incorporated by reference to Exhibit 4.1 to the Company’s Quarterly Report on Form 10-Q
for the quarterly period ended March 31, 2009).
| | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 4.1A | Second Amendment to Rights Agreement dated as of June 30, 2008 (incorporated by reference to Exhibit
4.1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2008).
| | ---- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



24







ImmuCell Corporation



| | 4.1B | Third Amendment to Rights Agreement dated as of August 9, 2011 (incorporated by reference to Exhibit
4.1 of the Company’s Quarterly Report on Form 10-Q for the three-month period ended June 30, 2011).
| | ---- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.1+ | Form of Indemnification Agreement (updated) entered into with each of the Company’s Directors
and Officers (incorporated by reference to Exhibit 10.3A to the Company’s Annual Report on Form 10-KSB for the year ended
December 31, 2006).
| | ----- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.2+ | 2000 Stock Option and Incentive Plan of the Company (incorporated by reference to Exhibit 10.6 of
the Company’s Annual Report on Form 10-K for the year ended December 31, 2008).
| | ----- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.3+ | Form of Incentive Stock Agreement (incorporated by reference to Exhibit 10.7 of the Company’s
Annual Report on Form 10-K for the year ended December 31, 2008).
| | ----- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.4+ | Amendment to Employment Agreement between the Company and Michael F. Brigham dated March 26, 2010
(incorporated by reference to Exhibit 10.6 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2009).
| | ----- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.5+ | Amendment to Employment Agreement between the Company and Joseph H. Crabb dated March 26, 2010 (incorporated
by reference to Exhibit 10.7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2009).
| | ----- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.6+ | 2010 Stock Option and Incentive Plan of the Company (incorporated
by reference to Exhibit 10.6 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2010).
| | ----- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.7+ | Form of Incentive Stock Option Agreement (incorporated by reference to Exhibit 10.7 of the Company’s
Annual Report on Form 10-K for the year ended December 31, 2010).
| | ----- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.8(1) | Development and Manufacturing Agreement between the Company
and Lonza Sales, Ltd. dated July 15, 2010 (incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on
Form 10-Q for the three-month period ended June 30, 2010).
| | ------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.9 | Commercial Promissory Note for $1,000,000 between the Company and TD Bank, N.A. dated August 13, 2010
(incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q for the three-month period ended
June 30, 2010).
| | ---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.10 | Commercial Promissory Note for $600,000 between the Company and TD Bank, N.A. dated August 13, 2010
(incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q for the three-month period ended
June 30, 2010).
| | ----- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.11 | Line of Credit Agreement and Promissory Note for up to $500,000 between the Company and TD Bank, N.A.
dated August 13, 2010 (incorporated by reference to Exhibit 10.4 of the Company’s Quarterly Report on Form 10-Q for the three-month
period ended June 30, 2010).
| | ----- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.12(1) | Loan Agreement between the Company and TD Bank, N.A.
dated August 13, 2010 (incorporated by reference to Exhibit 10.5 of the Company’s Quarterly Report on Form 10-Q for the
three-month period ended June 30, 2010).
| | -------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 10.13(1) | Contract Manufacture Agreement between the Company and
Norbrook Laboratories Limited dated as of September 27, 2010 (incorporated by reference to Exhibit 10.1 of the Company’s
Quarterly Report on Form 10-Q for the three-month period ended September 30, 2010).
| | -------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 14 | Code of Business Conduct and Ethics (incorporated by reference to Exhibit 14 of the Company’s
Annual Report on Form 10-K for the year ended December 31, 2008).
| | -- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 23* | Consent of Baker Newman & Noyes, LLC.
| | --- | -------------------------------------

| | 31* | Certifications required by Rule 13a-14(a).
| | --- | ------------------------------------------

| | 32 | Certification pursuant to Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.
| | -- | -------------------------------------------------------------------------------------------------------------








+ Management contract or compensatory plan
or arrangement.



| | (1) | Confidential Treatment as to certain portions has been
requested, which portions have been omitted and filed separately with the Securities and Exchange Commission.
| | --- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------



* Revised Filing.



25







REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM



To the Board of Directors and Stockholders

ImmuCell Corporation

Portland, Maine



We have audited the accompanying balance
sheets of ImmuCell Corporation (the Company) as of December 31, 2011 and 2010, and the related statements of operations, stockholders’
equity and cash flows for each of the three years in the period ended December 31, 2011. These financial statements are the
responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based
on our audits.



We conducted our audits in accordance with
the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform
the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits
included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate
in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates
made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable
basis for our opinion.



In our opinion, the financial statements
referred to above present fairly, in all material respects, the financial position of ImmuCell Corporation as of December 31,
2011 and 2010, and the results of its operations and its cash flows for each of the three years in the period ended December 31,
2011, in conformity with U.S. generally accepted accounting principles.



|Portland, Maine | /s/ Baker Newman & Noyes 
|--------------- | -------------------------
|March 27, 2012  | Limited Liability Company



F-1







ImmuCell Corporation



BALANCE SHEETS

AS OF DECEMBER 31, 2011 AND 2010



|                                                                                                                                     |  | 2011 |            |   | 2010 |  
|------------------------------------------------------------------------------------------------------------------------------------ |  | ---- | ---------- | - | ---- | -
|ASSETS                                                                                                                               |  |      |            |   |      |  
|CURRENT ASSETS:                                                                                                                      |  |      |            |   |      |  
|Cash and cash equivalents                                                                                                            |  | $    | 781,516    |   |      | $
|Short-term investments                                                                                                               |  |      | 4,178,000  |   |      |  
|Trade accounts receivable, net of allowance for doubtful accounts of $16,000 and $13,000 at December 31, 2011 and 2010, respectively |  |      | 346,447    |   |      |  
|Income taxes receivable                                                                                                              |  |      | 648        |   |      |  
|Other receivables                                                                                                                    |  |      | 36,701     |   |      |  
|Inventory                                                                                                                            |  |      | 1,666,465  |   |      |  
|Current portion of deferred tax asset                                                                                                |  |      | 59,016     |   |      |  
|Prepaid expenses                                                                                                                     |  |      | 81,807     |   |      |  
|Total current assets                                                                                                                 |  |      | 7,150,600  |   |      |  
|                                                                                                                                     |  |      |            |   |      |  
|NET PROPERTY, PLANT AND EQUIPMENT,at cost                                                                                            |  |      | 2,515,331  |   |      |  
|                                                                                                                                     |  |      |            |   |      |  
|LONG-TERM PORTION OF DEFERRED TAX ASSET                                                                                              |  |      | 1,306,335  |   |      |  
|                                                                                                                                     |  |      |            |   |      |  
|OTHER ASSETS,net                                                                                                                     |  |      | 19,006     |   |      |  
|                                                                                                                                     |  |      |            |   |      |  
|TOTAL ASSETS                                                                                                                         |  | $    | 10,991,272 |   |      | $
|                                                                                                                                     |  |      |            |   |      |  
|LIABILITIES AND STOCKHOLDERS’ EQUITY                                                                                                 |  |      |            |   |      |  
|CURRENT LIABILITIES:                                                                                                                 |  |      |            |   |      |  
|Accrued expenses                                                                                                                     |  | $    | 303,900    |   |      | $
|Accounts payable                                                                                                                     |  |      | 149,877    |   |      |  
|Current portion of bank debt                                                                                                         |  |      | 172,973    |   |      |  
|Deferred revenue                                                                                                                     |  |      | 8,250      |   |      |  
|Current portion of deferred tax liability                                                                                            |  |      | —          |   |      |  
|Total current liabilities                                                                                                            |  |      | 635,000    |   |      |  
|                                                                                                                                     |  |      |            |   |      |  
|LONG-TERM LIABILITIES:                                                                                                               |  |      |            |   |      |  
|Long-term portion of bank debt                                                                                                       |  |      | 1,267,939  |   |      |  
|Interest rate swap                                                                                                                   |  |      | 67,900     |   |      |  
|Total long-term liabilities                                                                                                          |  |      | 1,335,839  |   |      |  
|                                                                                                                                     |  |      |            |   |      |  
|TOTAL LIABILITIES                                                                                                                    |  |      | 1,970,839  |   |      |  
|                                                                                                                                     |  |      |            |   |      |  
|STOCKHOLDERS’ EQUITY:                                                                                                                |  |      |            |   |      |  
|Common stock, $0.10 par value per share, 8,000,000 shares authorized, 3,261,148 shares issued at December 31, 2011 and 2010          |  |      | 326,115    |   |      |  
|Capital in excess of par value                                                                                                       |  |      | 9,911,914  |   |      |  
|Accumulated deficit                                                                                                                  |  |      | (614,315   | ) |      |  
|Treasury stock, at cost, 257,114 and 287,496 shares at December 31, 2011  and 2010, respectively and 2008, respectively              |  |      | (562,469   | ) |      |  
|Accumulated other comprehensive (loss) income: interest rate swap                                                                    |  |      | (40,812    | ) |      |  
|Total stockholders’ equity                                                                                                           |  |      | 9,020,433  |   |      |  
|                                                                                                                                     |  |      |            |   |      |  
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY                                                                                           |  | $    | 10,991,272 |   |      | $



The accompanying notes are an integral part
of these financial statements.



F-2







ImmuCell Corporation



STATEMENTS OF OPERATIONS

FOR THE YEARS ENDED DECEMBER 31, 2011,
2010 AND 2009



|                                            |  | 2011 |           |   | 2010 |   |           | 2009 | 
|------------------------------------------- |  | ---- | --------- | - | ---- | - | --------- | ---- | 
|                                            |  |      |           |   |      |   |           |      | 
|Product sales                               |  | $    | 5,111,143 |   |      | $ | 4,386,196 |      | 
|Costs of goods sold                         |  |      | 2,297,339 |   |      |   | 2,083,718 |      | 
|Gross margin                                |  |      | 2,813,804 |   |      |   | 2,302,478 |      | 
|                                            |  |      |           |   |      |   |           |      | 
|Product development expenses                |  |      | 1,720,055 |   |      |   | 1,492,806 |      | 
|Sales and marketing expenses                |  |      | 869,869   |   |      |   | 650,889   |      | 
|Administrative expenses                     |  |      | 856,606   |   |      |   | 849,064   |      | 
|Other operating expenses                    |  |      | 3,446,530 |   |      |   | 2,992,759 |      | 
|                                            |  |      |           |   |      |   |           |      | 
|NET OPERATING INCOME (LOSS)                 |  |      | (632,726  | ) |      |   | (690,281  | )    | 
|                                            |  |      |           |   |      |   |           |      | 
|Other (expenses) revenues, net              |  |      | (63,955   | ) |      |   | 6,869     |      | 
|                                            |  |      |           |   |      |   |           |      | 
|INCOME (LOSS) BEFORE INCOME TAXES           |  |      | (696,681  | ) |      |   | (683,412  | )    | 
|                                            |  |      |           |   |      |   |           |      | 
|Income tax benefit                          |  |      | 287,171   |   |      |   | 298,728   |      | 
|                                            |  |      |           |   |      |   |           |      | 
|NET INCOME (LOSS)                           |  | $    | (409,510  | ) |      | $ | (384,684  | )    | 
|                                            |  |      |           |   |      |   |           |      | 
|Weighted average common shares outstanding: |  |      |           |   |      |   |           |      | 
|Basic                                       |  |      | 2,984,749 |   |      |   | 2,970,833 |      | 
|Diluted                                     |  |      | 2,984,749 |   |      |   | 2,970,833 |      | 
|                                            |  |      |           |   |      |   |           |      | 
|NET INCOME (LOSS) PER SHARE:                |  |      |           |   |      |   |           |      | 
|Basic                                       |  | $    | (0.14     | ) |      | $ | (0.13     | )    | 
|Diluted                                     |  | $    | (0.14     | ) |      | $ | (0.13     | )    | 



The accompanying notes are an integral part
of these financial statements.



F-3







ImmuCell Corporation



STATEMENTS OF STOCKHOLDERS’
EQUITY

FOR THE YEARS ENDED DECEMBER 31, 2009,
2010 AND 2011



|                                                   |  | Common
    Stock  $0.10 Par Value |           |  | Capital
    in  Excess of |   |         | Accumulated
     Surplus |  |   | Treasury
    Stock |   |  | Accumulated
    Other Comprehensive |          |   | Total
    Stockholders | 
|-------------------------------------------------- |  | --------------------------------- | --------- |  | ------------------------- | - | ------- | ------------------------ |  | - | ------------------ | - |  | ----------------------------------- | -------- | - | ---------------------- | 
|                                                   |  | Shares                            |           |  | Amount                    |   |         | Par
    Value            |  |   | (Deficit)          |   |  | Shares                              |          |   | Amount                 | 
|BALANCE,                                           |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|December 31, 2008                                  |  |                                   | 3,261,148 |  |                           | $ | 326,115 |                          |  | $ | 9,722,967          |   |  | $                                   | 396,372  |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Net loss                                           |  |                                   | —         |  |                           |   | —       |                          |  |   | —                  |   |  |                                     | (216,493 | ) |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Exercise of stock options                          |  |                                   | —         |  |                           |   | —       |                          |  |   | (66,508            | ) |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Stock-based compensation                           |  |                                   | —         |  |                           |   | —       |                          |  |   | 94,062             |   |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Tax benefits related
    to stock options          |  |                                   | —         |  |                           |   | —       |                          |  |   | 921                |   |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|BALANCE,                                           |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|December 31, 2009                                  |  |                                   | 3,261,148 |  |                           |   | 326,115 |                          |  |   | 9,751,442          |   |  |                                     | 179,879  |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Net loss                                           |  |                                   | —         |  |                           |   | —       |                          |  |   | —                  |   |  |                                     | (384,684 | ) |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Other comprehensive income: interest rate
    swap |  |                                   | —         |  |                           |   | —       |                          |  |   | —                  |   |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Total comprehensive loss                           |  |                                   | —         |  |                           |   | —       |                          |  |   | —                  |   |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Exercise of stock options                          |  |                                   | —         |  |                           |   | —       |                          |  |   | (563               | ) |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Stock-based compensation                           |  |                                   | —         |  |                           |   | —       |                          |  |   | 29,513             |   |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|BALANCE,                                           |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|December 31, 2010                                  |  |                                   | 3,261,148 |  |                           |   | 326,115 |                          |  |   | 9,780,392          |   |  |                                     | (204,805 | ) |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Net loss                                           |  |                                   | —         |  |                           |   | —       |                          |  |   | —                  |   |  |                                     | (409,510 | ) |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Other comprehensive loss: interest rate swap       |  |                                   | —         |  |                           |   | —       |                          |  |   | —                  |   |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Total comprehensive loss                           |  |                                   | —         |  |                           |   | —       |                          |  |   | —                  |   |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Exercise of stock options, net                     |  |                                   | —         |  |                           |   | —       |                          |  |   | 78,832             |   |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Stock-based compensation                           |  |                                   | —         |  |                           |   | —       |                          |  |   | 38,172             |   |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|Tax benefits related
    to stock options          |  |                                   | —         |  |                           |   | —       |                          |  |   | 14,518             |   |  |                                     | —        |   |                        | 
|                                                   |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|BALANCE,                                           |  |                                   |           |  |                           |   |         |                          |  |   |                    |   |  |                                     |          |   |                        | 
|December 31, 2011                                  |  |                                   | 3,261,148 |  |                           | $ | 326,115 |                          |  | $ | 9,911,914          |   |  | $                                   | (614,315 | ) |                        | 



The accompanying notes are an integral
part of these financial statements.



F-4







ImmuCell Corporation



STATEMENTS OF CASH FLOWS

FOR THE YEARS ENDED DECEMBER 31, 2011,
2010 AND 2009



|                                                                                      |  | 2011 |            |   | 2010 |   |            | 2009 | 
|------------------------------------------------------------------------------------- |  | ---- | ---------- | - | ---- | - | ---------- | ---- | 
|CASH FLOWS FROM OPERATING ACTIVITIES:                                                 |  |      |            |   |      |   |            |      | 
|Net income (loss)                                                                     |  | $    | (409,510   | ) |      | $ | (384,684   | )    | 
|Adjustments to reconcile net income (loss) to net cash used for operating activities: |  |      |            |   |      |   |            |      | 
|Depreciation                                                                          |  |      | 413,132    |   |      |   | 416,918    |      | 
|Amortization                                                                          |  |      | 5,240      |   |      |   | 2,593      |      | 
|Deferred income taxes                                                                 |  |      | (302,500   | ) |      |   | (299,171   | )    | 
|Stock-based compensation                                                              |  |      | 38,172     |   |      |   | 29,513     |      | 
|Loss on disposal of fixed assets                                                      |  |      | 10,822     |   |      |   | 575        |      | 
|Changes in:                                                                           |  |      |            |   |      |   |            |      | 
|Receivables                                                                           |  |      | 113,417    |   |      |   | (82,301    | )    | 
|Income taxes receivable/payable                                                       |  |      | 300        |   |      |   | 300        |      | 
|Inventory                                                                             |  |      | (65,449    | ) |      |   | (513,625   | )    | 
|Prepaid expenses and other assets                                                     |  |      | 159,484    |   |      |   | (60,913    | )    | 
|Accounts payable                                                                      |  |      | 59,479     |   |      |   | (26,811    | )    | 
|Accrued expenses                                                                      |  |      | (68,152    | ) |      |   | 108,993    |      | 
|Deferred revenue                                                                      |  |      | 8,250      |   |      |   | —          |      | 
|Net cash used for operating activities                                                |  |      | (37,315    | ) |      |   | (808,613   | )    | 
|                                                                                      |  |      |            |   |      |   |            |      | 
|CASH FLOWS FROM INVESTING ACTIVITIES:                                                 |  |      |            |   |      |   |            |      | 
|Purchase of property, plant and equipment                                             |  |      | (243,735   | ) |      |   | (116,547   | )    | 
|Maturities of short-term investments                                                  |  |      | 3,227,000  |   |      |   | 4,108,000  |      | 
|Purchases of short-term investments                                                   |  |      | (4,178,000 | ) |      |   | (3,725,000 | )    | 
|Net cash (used for) provided by investing activities                                  |  |      | (1,194,735 | ) |      |   | 266,453    |      | 
|                                                                                      |  |      |            |   |      |   |            |      | 
|CASH FLOWS FROM FINANCING ACTIVITIES:                                                 |  |      |            |   |      |   |            |      | 
|Proceeds from debt issuance                                                           |  |      | 600,000    |   |      |   | 1,000,000  |      | 
|Debt principal repayments                                                             |  |      | (145,232   | ) |      |   | (13,856    | )    | 
|Debt issuance costs                                                                   |  |      | —          |   |      |   | (26,489    | )    | 
|Tax benefits related to stock options                                                 |  |      | 14,518     |   |      |   | —          |      | 
|Proceeds from exercise of stock options                                               |  |      | 145,295    |   |      |   | 6,000      |      | 
|Net cash provided by financing activities                                             |  |      | 614,581    |   |      |   | 965,655    |      | 
|                                                                                      |  |      |            |   |      |   |            |      | 
|NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS                                  |  |      | (617,469   | ) |      |   | 423,495    |      | 
|                                                                                      |  |      |            |   |      |   |            |      | 
|BEGINNING CASH AND CASH EQUIVALENTS                                                   |  |      | 1,398,985  |   |      |   | 975,490    |      | 
|                                                                                      |  |      |            |   |      |   |            |      | 
|ENDING CASH AND CASH EQUIVALENTS                                                      |  | $    | 781,516    |   |      | $ | 1,398,985  |      | 
|                                                                                      |  |      |            |   |      |   |            |      | 
|INCOME TAXES (PAID) REFUNDED, NET                                                     |  | $    | (510       | ) |      | $ | (144       | )    | 
|                                                                                      |  |      |            |   |      |   |            |      | 
|INTEREST EXPENSE PAID                                                                 |  | $    | (78,737    | ) |      | $ | (20,000    | )    | 
|                                                                                      |  |      |            |   |      |   |            |      | 
|NON-CASH ACTIVITIES:                                                                  |  |      |            |   |      |   |            |      | 
|Change in capital expenditures included in accounts payable and accrued expenses      |  | $    | (15,341    | ) |      | $ | 32,839     |      | 
|Net change in fair value of interest rate swap                                        |  | $    | 50,443     |   |      | $ | (9,631     | )    | 



The accompanying notes are an integral part
of these financial statements.



F-5







ImmuCell Corporation



Notes to Audited Financial Statements



| | 1. | BUSINESS OPERATIONS
| | -- | -------------------



ImmuCell Corporation’s
(the Company) purpose is to create scientifically-proven and practical products that result in a measurable economic impact on
animal health and productivity in the dairy and beef industries. The Company was originally incorporated in Maine in 1982 and reincorporated
in Delaware in 1987, in conjunction with its initial public offering of common stock. The Company is subject to certain risks associated
with its stage of development including dependence on key individuals, competition from other larger companies, the successful
sales of existing products and the development and acquisition of additional commercially viable products with appropriate regulatory
approvals, where applicable.



| | 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
| | -- | ------------------------------------------



| | (a) | Basis of presentation
| | --- | ---------------------



We have prepared the
accompanying audited financial statements reflecting all adjustments, all of which are of a normal recurring nature, that are,
in our opinion, necessary in order to make the financial statements not misleading. We follow accounting standards set by the Financial
Accounting Standards Board (FASB). The FASB sets generally accepted accounting principles (GAAP) that we follow to ensure we consistently
report our financial condition, results of operations, earnings per share and cash flows. References to GAAP issued by the FASB
in these footnotes are to the FASBAccounting Standards CodificationTM (Codification). The FASB finalized the Codification
effective for periods ending on or after September 15, 2009. Certain prior year accounts have been reclassified to conform with
the 2011 financial statement presentation.



| | (b) | Cash, Cash Equivalents and Short-Term Investments
| | --- | -------------------------------------------------



We consider all highly
liquid investment instruments that mature within three months of their purchase dates to be cash equivalents. Cash equivalents
are principally invested in securities backed by the U.S. government. Amounts in excess of these FDIC limits per bank that are
not invested in securities backed by the U.S. government aggregated $281,000 and $899,000 at December 31, 2011 and 2010, respectively.
Certain cash balances in excess of Federal Deposit Insurance Corporation (FDIC) limits per financial institution are maintained
in money market accounts at financial institutions that are secured, in part, by the Securities Investor Protection Corporation.
Short-term investments are classified as held to maturity and are comprised principally of certificates of deposits that mature
in more than three months from their purchase dates and not more than twelve months from the balance sheet date and are held at
different financial institutions that are insured by the FDIC within the FDIC insurance limit of $250,000 per institution per depositor.
We are required by bank debt covenant to maintain at least $1,000,000 of otherwise unrestricted cash, cash equivalents and short-term
investments. Cash, cash equivalents and short-term investments consist of the following (in thousands):



|                          |  | As of December 31, |       |  | (Decrease) |  
|------------------------- |  | ------------------ | ----- |  | ---------- | -
|                          |  | 2011               |       |  | 2010       |  
|Cash and cash equivalents |  | $                  | 782   |  |            | $
|Short-term investments    |  |                    | 4,178 |  |            |  
|                          |  | $                  | 4,960 |  |            | $



| | (c) | Trade Receivables
| | --- | -----------------



Trade receivables are
carried at the original invoice amount less an estimate made for doubtful collection. Management determines the allowance for doubtful
accounts on a monthly basis by identifying troubled accounts and by using historical experience applied to an aging of accounts.
Trade receivables are written off when deemed uncollectible. Recoveries of trade receivables previously written off are recorded
as income when received. A trade receivable is considered to be past due if any portion of the receivable balance is outstanding
for more than 30 days. Interest is charged on past due trade receivables.



F-6







ImmuCell Corporation



Notes to Audited Financial Statements



| | (d) | Inventory
| | --- | ---------



Inventory includes raw
materials, work-in-process and finished goods and is recorded at the lower of cost, on the first-in, first-out method, or market
(net realizable value). Work-in-process and finished goods inventories include materials, labor and manufacturing overhead. Inventory
consists of the following (in thousands):



|                |  | As of December 31, |       |  | (Decrease) |  
|--------------- |  | ------------------ | ----- |  | ---------- | -
|                |  | 2011               |       |  | 2010       |  
|Raw materials   |  | $                  | 218   |  |            | $
|Work-in-process |  |                    | 1,000 |  |            |  
|Finished goods  |  |                    | 448   |  |            |  
|                |  | $                  | 1,666 |  |            | $



| | (e) | Property, Plant and Equipment
| | --- | -----------------------------



We depreciate property,
plant and equipment on the straight-line method by charges to operations in amounts estimated to expense the cost of the assets
from the date they are first put into service to the end of the estimated useful lives of the assets. The cost of the building,
acquired in 1993, and the 2001 and 2007 additions thereto, are being depreciated through 2023. Related building improvements are
depreciated over ten year periods. Large and durable fixed assets are depreciated over their useful lives that are generally estimated
to be ten years. Other fixed assets and computer equipment are depreciated over their useful lives that are generally estimated
to be five and three years, respectively. See Note 3.



| | (f) | Intangible Assets
| | --- | -----------------



We amortize intangible
assets on the straight-line method by charges to operations in amounts estimated to expense the cost of the assets from the date
they are first put into service to the end of the estimated useful lives of the assets. The $250,000 acquisition of product rights
related to Wipe OutÒ Dairy Wipes in December 1999 was amortized
to cost of sales over the ten-year period ended in December 2009, and the related manufacturing rights acquired in 2001 for $45,000
were amortized to cost of sales through December 2009. In connection with certain credit facilities entered into during the third
quarter of 2010, we incurred debt issue costs of approximately $26,000, which costs are being amortized to other revenues (expenses),
net over the terms of the credit facilities.



We continually assess
the realizability of these assets in accordance with the impairment provisions of Codification Topic 360, Accounting for the
Impairment or Disposal of Long-Lived Assets. If an impairment review is triggered, we evaluate the carrying value of long-lived
assets by determining if impairment exists based on estimated undiscounted future cash flows over the remaining useful life of
the assets and comparing that value to the carrying value of the assets. If the carrying value of the asset is greater than the
estimated future cash flows, the asset is written down to its estimated fair value. The cash flow estimates that are used contain
our best estimates, using appropriate and customary assumptions and projections at the time. We also review the estimated useful
life of intangible assets at the end of each reporting period, making any necessary adjustments.



| | (g) | Disclosure of Fair Value of Financial Instruments and Concentration of Risk
| | --- | ---------------------------------------------------------------------------



Financial instruments
consist mainly of cash and cash equivalents, short-term investments, accounts receivable, accounts payable, and an interest rate
swap. Financial instruments that potentially subject the Company to concentrations of credit risk are principally cash, cash equivalents,
short-term investments and accounts receivable. We invest our short-term investments in financial instruments that are insured
by the FDIC. We account for fair value measurements in accordance with Codification Topic 820, Fair Value Measurements and Disclosures,
which defines fair value, establishes a framework for measuring fair value and requires additional disclosures about fair value
measurements. Codification Topic 820 applies to fair value measurements that are already required or permitted by other accounting
standards, except for measurements of share-based payments and measurements that are similar to, but not intended to be, fair value
and does not change existing guidance as to whether or not an instrument is carried at fair value. The adoption of this Statement
did not have a material impact on our financial condition, results of operations, earnings per share, cash flows or financial statement
disclosures.





F-7









ImmuCell Corporation



Notes to Audited Financial Statements
(continued)



Concentration of credit
risk with respect to accounts receivable is principally limited to certain customers to whom we make substantial sales. To reduce
risk, we routinely assess the financial strength of our customers and, as a consequence, believe that our accounts receivable credit
risk exposure is limited. We maintain an allowance for potential credit losses, but historically we have not experienced significant
credit losses related to an individual customer or groups of customers in any particular industry or geographic area. We did incur
a net loss of $14,000 during 2010 as the result of the bankruptcy of a former distributor. The carrying amounts of our financial
instruments approximate fair market value.



We believe that supplies
and raw materials for the production of our products are available from more than one vendor or farm. Our policy is to maintain
more than one source of supply for the components used in our products. However, there is a risk that we could have difficulty
in efficiently acquiring essential supplies.



| | (h) | Interest Rate Swap Agreement
| | --- | ----------------------------



As described in Note 6,
we entered into an interest rate swap agreement in 2010. All derivatives are recognized on the balance sheet at their fair value.
On the date the agreement was entered into, we designated the derivative as a hedge of the variability of cash flows to be paid
related to the long-term debt described in Note 6. The agreement has been determined to be highly effective in hedging the variability
of identified cash flows, so changes in the fair market value of the interest rate swap agreement are recorded in other comprehensive
income, until earnings are affected by the variability of cash flows (e.g. when periodic settlements on a variable-rate asset or
liability are recorded in earnings). We formally documented the relationship between the interest rate swap agreement and the related
hedged items. We also formally assess, both at this interest rate swap agreement’s inception and on an ongoing basis, whether
the agreement is highly effective in offsetting changes in cash flow of hedged items.



| | (i) | Revenue Recognition
| | --- | -------------------



Revenues related to the
sale of manufactured products are recorded when title and risk of loss have passed to the customer, which is at the time of shipment
and when collectability is reasonably assured. Royalty income is recognized on the accrual basis based on sales as reported to
us by our licensee and is recorded as other revenues (expenses), net.



| | (j) | Expense Recognition
| | --- | -------------------



Advertising costs are
expensed when incurred, which is generally during the month in which the advertisement is published. Advertising expenses amounted
to $5,000, $16,000 and $33,000 during the years ended December 31, 2011, 2010 and 2009, respectively. All product development expenses
are expensed as incurred, as are all related patent costs.



| | (k) | Income Taxes
| | --- | ------------



We account for income
taxes in accordance with Codification Topic 740, Income Taxes,which requires that we recognize a current tax liability
or asset for current taxes payable or refundable and a deferred tax liability or asset for the estimated future tax effects of
temporary differences and carryforwards to the extent they are realizable. We believe it is more likely than not that the deferred
tax assets will be realized through future taxable income and future tax effects of temporary differences between book income and
taxable income. Accordingly, we have not established a valuation allowance for the deferred tax assets. Codification Topic 740-10
clarifies the accounting for income taxes by prescribing a minimum recognition threshold that a tax position must meet before being
recognized in the financial statements. In the ordinary course of business, there are transactions and calculations where the ultimate
tax outcome is uncertain. In addition, we are subject to periodic audits and examinations by the IRS and other taxing authorities.
We have evaluated the positions taken on our filed tax returns. We have concluded that no uncertain tax positions exist as of December
31, 2011. Although we believe that our estimates are reasonable, actual results could differ from these estimates. See Note 8.



F-8







ImmuCell Corporation



Notes to Audited Financial Statements
(continued)



| | (l) | Net Income (Loss) Per Common Share
| | --- | ----------------------------------



The net loss per common
share has been computed in accordance with Codification Topic 260-10, Earnings Per Share, by dividing the net loss by the
weighted average number of common shares outstanding during the period, without giving consideration to outstanding stock options
because the impact would be anti-dilutive.



|                                                                                                    |  | Year Ended December 31, |          
|--------------------------------------------------------------------------------------------------- |  | ----------------------- | ---------
|                                                                                                    |  | 2011                    |          
|                                                                                                    |  |                         |          
|Weighted average number of shares outstanding during the period                                     |  |                         | 2,984,749
|                                                                                                    |  |                         |          
|Dilutive stock options                                                                              |  |                         | —        
|                                                                                                    |  |                         |          
|Shares that could have been repurchased with the proceeds from the dilutive stock options           |  |                         | —        
|                                                                                                    |  |                         |          
|Diluted number of shares outstanding during the period                                              |  |                         | 2,984,749
|                                                                                                    |  |                         |          
|Outstanding stock options not included in the calculation because the effect would be anti-dilutive |  |                         | 236,000  



For additional disclosures
regarding the outstanding common stock options, see Notes 9(a) and 9(b).



| | (m) | Employee Stock-Based Compensation
| | --- | ---------------------------------



We account for the stock-based
compensation in accordance with Codification Topic 718, Compensation-Stock Compensation, which generally requires us to
recognize non-cash compensation expense for stock-based payments using the fair-value-based method. The fair value of each stock
option grant has been estimated on the date of grant using the Black-Scholes option pricing model, as detailed in Note 9(b). Accordingly,
we recorded $38,000, $30,000 and $94,000 of compensation expense pertaining to stock-based compensation, which resulted in an increase
in loss before income taxes of approximately $0.01, $0.01 and $0.03 per share (before the effect of income taxes), during the years
ended December 31, 2011, 2010 and 2009, respectively. Codification Topic 718 requires us to reflect gross tax savings resulting
from tax deductions in excess of expense reflected in our financial statements as a financing cash flow, but there were no significant
tax deductions during the three years in the period ended December 31, 2011.



| | (n) | Use of Estimates
| | --- | ----------------



The preparation of financial
statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the period. Actual amounts could differ from those estimates.





F-9







ImmuCell Corporation



Notes to Audited Financial Statements
(continued)



| | (o) | New Accounting Pronouncements to be Adopted
| | --- | -------------------------------------------



Accounting Standards Update (ASU) No. 2011-05,
Presentation of Comprehensive Income (Loss) (Topic 220) will be adopted during the first quarter of 2012. Under ASU 2011-05,
we have the option to present the total of comprehensive income (loss), the components of net income (loss), and the components
of other comprehensive income (loss) either in a single continuous statement of comprehensive income (loss) or in two separate
but consecutive statements. This guidance eliminates the option to report components of other comprehensive income (loss) as part
of the statement of changes in stockholders’ equity. Under either option, we are required to present each component of net
income (loss) along with total net income (loss), each component of other comprehensive income (loss) along with a total for other
comprehensive income (loss), and a total amount for comprehensive income (loss). In a single continuous statement, we are required
to present the components of net income (loss) and total net income (loss), the components of other comprehensive income (loss)
and a total for other comprehensive income (loss), along with the total of comprehensive income (loss) in that statement. In the
two statement approach, we are required to present components of net income (loss) and total net income (loss) in our statement
of operations. The statement of other comprehensive income (loss) should immediately follow the statement of operations and include
the components of other comprehensive income (loss) and a total for other comprehensive income (loss), along with a total for comprehensive
income (loss). ASU 2011-05 is effective for fiscal years, and interim periods within those years, beginning after December 15,
2011, and retrospective application is required. The guidance is effective for our first quarter ending March 31, 2012. The Company
believes the adoption will impact only the presentation of the financial statements.



| | 3. | PROPERTY, PLANT AND EQUIPMENT
| | -- | -----------------------------



Property, plant and equipment consisted
of the following, at cost (in thousands):



|                                       |  | As of December 31, |      
|-------------------------------------- |  | ------------------ | -----
|                                       |  | 2011               |      
|Laboratory and manufacturing equipment |  | $                  | 2,979
|Building and improvements              |  |                    | 2,667
|Office furniture and equipment         |  |                    | 253  
|Construction in progress               |  |                    | 1    
|Land                                   |  |                    | 50   
|Property, plant and equipment, gross   |  |                    | 5,950
|Less-accumulated depreciation          |  |                    | 3,435
|Property, plant and equipment, net     |  | $                  | 2,515



| | 4. | OTHER ASSETS
| | -- | ------------



Other assets consisted
of the following (in thousands):



|                                                  |  | As of December 31, |   
|------------------------------------------------- |  | ------------------ | --
|                                                  |  | 2011               |   
|Security deposits                                 |  | $                  | 1 
|Debt issue costs                                  |  |                    | 26
|Interest rate swap(1)                             |  |                    | — 
|Other assets, gross                               |  |                    | 27
|                                                  |  |                    |   
|Less-Accumulated amortization of debt issue costs |  |                    | 8 
|Other assets, net                                 |  | $                  | 19



(1) Amount included in long-term liabilities
as of December 31, 2011.



F-10







ImmuCell Corporation



Notes to Audited Financial Statements
(continued)



| | 5. | ACCRUED EXPENSES
| | -- | ----------------



Accrued expenses consisted
of the following (in thousands):



|                  |  | As of December 31, |    
|----------------- |  | ------------------ | ---
|                  |  | 2011               |    
|Professional fees |  | $                  | 40 
|Payroll           |  |                    | 128
|Other             |  |                    | 136
|                  |  | $                  | 304



| | 6. | BANK DEBT
| | -- | ---------



During the third quarter
of 2010, we agreed to terms of certain credit facilities with TD Bank, N.A. aggregating up to approximately $2,100,000, which are
secured by substantially all of our assets. These credit facilities are comprised of a $1,000,000 ten-year mortgage loan, a $600,000
fifty-four month note and a $500,000 line of credit, which is renewable annually. Proceeds from the $1,000,000 mortgage were received
during the third quarter of 2010. Based on a 15-year amortization schedule, a balloon principal payment of approximately $452,000
will be due in the third quarter of 2020. We hedged our interest rate exposure on this mortgage loan with an interest rate swap
agreement that effectively converted a floating interest rate to the fixed rate of 6.04%. All derivatives are recognized on the
balance sheet at their fair value. The agreement has been determined to be highly effective in hedging the variability of the identified
cash flows and has been designated as a cash flow hedge of the variability in the hedged interest payments. Changes in the fair
value of the interest rate swap agreement are recorded in other comprehensive (loss) income, net of taxes. The original notional
amount of the interest rate swap agreement of $1,000,000 amortizes in accordance with the amortization of the mortgage. As the
result of our decision to hedge this interest rate risk, we recorded other comprehensive loss in the amount of approximately $(50,000)
as of December 31, 2011 and other comprehensive income in the amount of approximately $10,000 as of December 31, 2010, which reflects
the change in fair value of the interest rate swap (liability) asset, net of taxes. The fair value of the interest rate swap has
been determined using observable market-based inputs or unobservable inputs that are corroborated by market data. Accordingly,
the interest rate swap is classified as level 2 within the fair value hierarchy provided in Codification Topic 820, Fair Value
Measurements and Disclosures. Proceeds from the $600,000 note were received during the first quarter of 2011. Interest on the
note is variable at the higher rate of 4.25% or the one month London Interbank Offered Rate (LIBOR) plus 3.25%. The $500,000 line
of credit is available as needed and has been extended through May 31, 2012 and is renewable annually thereafter. Interest on any
borrowings against the line of credit will be variable at the higher rate of 4.25% or the one month LIBOR plus 3.5%. These credit
facilities are subject to certain financial covenants. Principal payments due under debt outstanding as of December 31, 2011 are
reflected in the following table by the year that payments are due (in thousands):



|                    |  | Year ending December 31, |     |  |      |  
|------------------- |  | ------------------------ | --- |  | ---- | -
|                    |  | 2012                     |     |  | 2013 |  
|$1,000,000 mortgage |  | $                        | 45  |  |      | $
|$600,000 note       |  |                          | 128 |  |      |  
|Total               |  | $                        | 173 |  |      | $



F-11







ImmuCell Corporation



Notes to Audited Financial Statements
(continued)



| | 7. | OTHER (EXPENSES) REVENUES, NET
| | -- | ------------------------------



Other (expenses) revenues,
net consisted of the following (in thousands):



|                           |  | Year Ended December 31, |    
|-------------------------- |  | ----------------------- | ---
|                           |  | 2011                    |    
|Royalty income             |  | $                       | 11 
|Interest income            |  |                         | 15 
|Interest expense           |  |                         | (81
|Debt issuance amortization |  |                         | (5 
|Other gains (losses)       |  |                         | (4 
|                           |  | $                       | (64



| | 8. | INCOME TAXES
| | -- | ------------



Our income tax benefit
aggregated $287,000, $299,000 and $212,000 (41%, 44% and 49% of the loss before income taxes, respectively) for the years ended
December 31, 2011, 2010 and 2009, respectively. The income tax provision consists of the following (in thousands):



|         |  | Year Ended December 31, |    
|-------- |  | ----------------------- | ---
|         |  | 2011                    |    
|Current  |  |                         |    
|Federal  |  | $                       | —  
|State    |  |                         | (1 
|Foreign  |  |                         | —  
|         |  |                         | (1 
|Deferred |  |                         |    
|Federal  |  |                         | 260
|State    |  |                         | 28 
|         |  |                         | 288
|         |  |                         |    
|Total    |  | $                       | 287



The actual income tax
expense differs from the expected tax computed by applying the U.S. Federal corporate tax rate of 34% to income before income tax
as follows (in thousands):



|                                           |  | Year Ended December 31, |    
|------------------------------------------ |  | ----------------------- | ---
|                                           |  | 2011                    |    
|Computed expected tax benefit              |  | $                       | 237
|State income taxes, net of federal benefit |  |                         | 36 
|Share-based compensation                   |  |                         | (8 
|Research and development tax credit        |  |                         | 24 
|Other                                      |  |                         | (2 
|Total income tax benefit                   |  | $                       | 287



F-12







ImmuCell Corporation



Notes to Audited Financial Statements
(continued)



The significant components
of our deferred tax assets and liabilities are as follows (in thousands):



|                                        |  | As of December 31, |      
|--------------------------------------- |  | ------------------ | -----
|                                        |  | 2011               |      
|Deferred tax assets (liabilities):      |  |                    |      
|Deferred revenue and other reserves     |  | $                  | 10   
|Product rights                          |  |                    | 237  
|Depreciation                            |  |                    | (33  
|Research and development tax credit     |  |                    | 180  
|Federal net operating loss carryforward |  |                    | 652  
|State net operating loss carryforward   |  |                    | 275  
|Interest rate swap                      |  |                    | 27   
|Prepaid expenses and other              |  |                    | 17   
|Deferred tax assets                     |  | $                  | 1,365



In order to
accelerate the utilization of available net operating loss carryforwards in advance of their expiration dates, we elected to
increase income for federal income tax purposes by capitalizing research and experimentation expenditures aggregating
$1,731,000 for our 2000 and 2001 tax returns. Accordingly, we recorded amortization of these capitalized expenditures of
approximately $90,000 in 2000 and $173,000 in each of the nine years ended December 31, 2009 and $84,000 for the year ending
December 31, 2010 for tax return purposes only. We carried back our 2008 federal net operating loss of approximately
$1,151,000 to previous years for tax return purposes, and we have a state net operating loss carryforward of approximately
$3,082,000 that expires in 2028, 2029, 2030 and 2031, if not utilized before then, and a federal net operating loss
carryforward of approximately $1,916,000 that expires in 2029, 2030 and 2031, if not utilized before then. The $965,000
licensing payment that we made during the fourth quarter of 2004 was treated as an intangible asset and is being amortized
over 15 years, for tax return purposes only.



The Company files income
tax returns in the U.S. federal jurisdiction and several state jurisdictions. With few exceptions, the Company is no longer subject
to income tax examinations by tax authorities for years before 2008. We currently have no tax examinations in progress. We also
have not paid additional taxes, interest or penalties as a result of tax examinations nor do we have any unrecognized tax benefits
for any of the periods in the accompanying financial statements.



| | 9. | STOCKHOLDERS’ EQUITY
| | -- | --------------------



| | (a) | Stock Option Grants Outside of Stock Option Plans
| | --- | -------------------------------------------------



On March 1, 1999, 31,100
non-qualified stock options were issued to each of the three then-serving executive officers at an exercise price of $1.31 per
share, the then current market price of our common stock, vesting as to one-third in each of March 2000, 2001 and 2002. These options
were granted outside of the stock option plans described below. In 2000, 20,734 of these options terminated when one of the officers
separated from the Company. In September 2001, that former officer exercised 10,300 of these options and 66 of these options expired
without being exercised. In February 2009, the aggregate of 34,200 of the outstanding options were exercised by two current executive
officers and the remaining 28,000 of these options expired without being exercised. The aggregate intrinsic value of these outstanding
options approximated $22,000 as of December 31, 2008.



| | (b) | Stock Option Plans
| | --- | ------------------



In May 1989, the stockholders
approved the 1989 Stock Option and Incentive Plan (the “1989 Plan”) pursuant to the provisions of the Internal Revenue
Code of 1986, under which employees may be granted options to purchase shares of the Company’s common stock at i) no less
than fair market value on the date of grant in the case of incentive stock options and ii) no less than 85% of fair market value
on the date of grant in the case of non-qualified stock options. Vesting requirements are determined by the Compensation and Stock
Option Committee of the Board of Directors on a case by case basis. All options granted under the 1989 Plan expire no later than
ten years from the date of grant. The 1989 Plan expired in March 1999, and no further options may be granted under the 1989 Plan.
The last 41,800 options under the 1989 plan were exercised in February 2009 in accordance with their terms.



F-13







ImmuCell Corporation



Notes to Audited Financial Statements
(continued)



In June 2000, the
stockholders approved the 2000 Stock Option and Incentive Plan (the “2000 Plan”) pursuant to the provisions of
the Internal Revenue Code of 1986, under which employees and certain service providers may be granted options to purchase
shares of the Company’s common stock at i) no less than fair market value on the date of grant in the case of incentive
stock options and ii) no less than 85% of fair market value on the date of grant in the case of non-qualified stock options.
Vesting requirements are determined by the Compensation and Stock Option Committee of the Board of Directors on a case by
case basis. Originally, 250,000 shares of common stock were reserved for issuance under the 2000 Plan. The stockholders of
the Company approved an increase in this number to 500,000 shares in June 2001. All options granted under the 2000 Plan
expire no later than ten years from the date of grant. The 2000 Plan expired in February 2010, after which date no further
options could be granted under the 2000 Plan. However, outstanding options under the 2000 Plan may be exercised in accordance
with their terms.



In June 2010, the
stockholders approved the 2010 Stock Option and Incentive Plan (the “2010 Plan”) pursuant to the provisions of
the Internal Revenue Code of 1986, under which employees and certain service providers may be granted options to purchase
shares of the Company’s common stock at i) no less than fair market value on the date of grant in the case of incentive
stock options and ii) no less than 85% of fair market value on the date of grant in the case of non-qualified stock options.
Vesting requirements are determined by the Compensation and Stock Option Committee of the Board of Directors on a case by
case basis. At that time, 300,000 shares of common stock were reserved for issuance under the 2010 Plan. All options granted
under the 2010 Plan expire no later than ten years from the date of grant.



Activity under the stock
option plans described above was as follows:



|                                 |  | 1989 Plan |         |   | 2000 Plan |  |          | 2010 Plan |  |  | Weighted Average Exercise Price |   |  | Aggregate Intrinsic Value |     
|-------------------------------- |  | --------- | ------- | - | --------- |  | -------- | --------- |  |  | ------------------------------- | - |  | ------------------------- | ----
|Outstanding at December 31, 2008 |  |           | 41,800  |   |           |  | 312,000  |           |  |  | —                               |   |  | $                         | 3.79
|Grants                           |  |           | —       |   |           |  | 115,000  |           |  |  | —                               |   |  | $                         | 1.94
|Terminations                     |  |           | —       |   |           |  | (26,000  | )         |  |  | —                               |   |  | $                         | 3.43
|Exercises                        |  |           | (41,800 | ) |           |  | —        |           |  |  | —                               |   |  | $                         | 1.31
|                                 |  |           |         |   |           |  |          |           |  |  |                                 |   |  |                           |     
|Outstanding at December 31, 2009 |  |           | —       |   |           |  | 401,000  |           |  |  | —                               |   |  | $                         | 3.54
|Grants                           |  |           | —       |   |           |  | 20,000   |           |  |  | 25,500                          |   |  | $                         | 3.48
|Terminations                     |  |           | —       |   |           |  | (169,000 | )         |  |  | (1,000                          | ) |  | $                         | 3.84
|Exercises                        |  |           | —       |   |           |  | (3,000   | )         |  |  | —                               |   |  | $                         | 2.00
|                                 |  |           |         |   |           |  |          |           |  |  |                                 |   |  |                           |     
|Outstanding at December 31, 2010 |  |           | —       |   |           |  | 249,000  |           |  |  | 24,500                          |   |  | $                         | 3.36
|Grants                           |  |           | —       |   |           |  | —        |           |  |  | 25,000                          |   |  | $                         | 5.72
|Terminations                     |  |           | —       |   |           |  | (31,500  | )         |  |  | —                               |   |  | $                         | 5.05
|Exercises                        |  |           | —       |   |           |  | (31,000  | )         |  |  | —                               |   |  | $                         | 4.79
|                                 |  |           |         |   |           |  |          |           |  |  |                                 |   |  |                           |     
|Outstanding at December 31, 2011 |  |           | —       |   |           |  | 186,500  |           |  |  | 49,500                          |   |  | $                         | 3.19
|                                 |  |           |         |   |           |  |          |           |  |  |                                 |   |  |                           |     
|Exercisable at December 31, 2011 |  |           | —       |   |           |  | 64,000   |           |  |  | —                               |   |  | $                         | 4.28
|                                 |  |           |         |   |           |  |          |           |  |  |                                 |   |  |                           |     
|Reserved for future grants       |  |           | —       |   |           |  | —        |           |  |  | 250,500                         |   |  |                           |     



F-14







ImmuCell Corporation



Notes to Audited Financial Statements
(continued)



At December 31,
2011, 236,000 shares of common stock were reserved for future issuance under all outstanding stock options described above,
and an additional 250,500 shares of common stock were reserved for the potential issuance of stock options in the future
under the 2010 Plan. The weighted average remaining life of the options outstanding under the 2000 Plan and the 2010 Plan as
of December 31, 2011 was approximately six years and six months. The exercise price of the options outstanding as of December
31, 2011 ranged from $1.70 to $7.00 per share. The 25,000 stock options granted during 2011 had exercise prices between $4.91
and $5.75 per share. The 45,500 stock options granted during 2010 had exercise prices between $3.15 and $3.99 per share. The
115,000 stock options granted during 2009 had exercise prices between $1.70 and $3.99 per share. The aggregate intrinsic
value of options exercised during 2011, 2010 and 2009 approximated $49,000, $3,000 and $5,000, respectively. The
weighted-average grant date fair values of options granted during 2011, 2010 and 2009 were $2.40, $1.45 and $0.81 per share,
respectively. The fair value of each stock option grant has been estimated on the date of grant using the Black-Scholes
option pricing model, for the purpose discussed in Note 2(m), with the following weighted-average assumptions:



|                        |  | 2011 |         |   | 2010 |  |         | 2009 | 
|----------------------- |  | ---- | ------- | - | ---- |  | ------- | ---- | 
|Risk-free interest rate |  |      | 1.1     | % |      |  | 2.4     | %    | 
|Dividend yield          |  |      | 0       | % |      |  | 0       | %    | 
|Expected volatility     |  |      | 47.6    | % |      |  | 44.2    | %    | 
|Expected life           |  |      | 5 years |   |      |  | 5 years |      | 



As of December 31, 2011,
total unrecognized stock-based compensation related to non-vested stock options aggregated approximately $84,000. That cost is
expected to be recognized at a declining rate through December 31, 2014 which represents the remaining vesting period of the outstanding
non-vested stock options.



| | (c) | Stock Option Exercises
| | --- | ----------------------



During the year ended
December 31, 2009, four employees exercised stock options covering the aggregate of 76,000 shares. These options were exercised
for cash, resulting in total proceeds of $99,750. During the year ended December 31, 2010, three employees exercised 1,000 stock
options each covering the aggregate of 3,000 shares. These options were exercised for cash, resulting in total proceeds of $6,000.
During the year ended December 31, 2011, eight employees exercised stock options covering the aggregate of 31,000 shares. 30,000
of these options were exercised for cash, resulting in total proceeds of $145,000, and 1,000 of these options were exercised by
the surrender of 618 shares of common stock with a fair market value of $3,200 at the time of exercise.



| | (d) | Common Stock Rights Plan
| | --- | ------------------------



In September 1995, ourBoard of Directors adopted a Common Stock Rights Plan (The Rights Plan) and declared a dividend of one common share purchase
right (a “Right”) for each of the then outstanding shares of the common stock of the Company. Each Right entitles the
registered holder to purchase from the Company one share of common stock at an initial purchase price of $70.00 per share, subject
to adjustment. The description and terms of the Rights are set forth in a Rights Agreement between the Company and American Stock
Transfer & Trust Co., as Rights Agent.



The Rights (as amended)
become exercisable and transferable apart from the common stock upon the earlier of i) 10 days following a public announcement
that a person or group (Acquiring Person) has, without the prior consent of the Continuing Directors (as such term is defined in
the Rights Agreement), acquired beneficial ownership of 20% or more of the outstanding common stock or ii) 10 days following commencement
of a tender offer or exchange offer the consummation of which would result in ownership by a person or group of 20% or more of
the outstanding common stock (the earlier of such dates being called the Distribution Date).



Upon the Distribution
Date, the holder of each Right not owned by the Acquiring Person would be entitled to purchase common stock at a discount to the
initial purchase price of $70.00 per share, effectively equal to one half of the market price of a share of common stock on the
date the Acquiring Person becomes an Acquiring Person. If, after the Distribution Date, the Company should consolidate or merge
with any other entity and the Company were not the surviving company, or, if the Company were the surviving company, all or part
of the Company’s common stock were changed or exchanged into the securities of any other entity, or if more than 50% of the
Company’s assets or earning power were sold, each Right would entitle its holder to purchase, at the Rights’ then-current
purchase price, a number of shares of the acquiring company’s common stock having a market value at that time equal to twice
the Right’s exercise price.



F-15







ImmuCell Corporation



Notes to Audited Financial Statements
(continued)



At any time after a person
or group becomes an Acquiring Person and prior to the acquisition by such person or group of 50% or more of the outstanding common
stock, the Board of Directors of the Company may exchange the Rights (other than Rights owned by such person or group which have
become void), in whole or in part, at an exchange ratio of one share of common stock per Right (subject to adjustment). At any
time prior to 14 days following the date that any person or group becomes an Acquiring Person (subject to extension by the Board
of Directors), the Board of Directors of the Company may redeem the then outstanding Rights in whole, but not in part, at a price
of $0.005 per Right, subject to adjustment.



On June 8, 2005, our
Board voted to authorize an amendment of the Rights Agreement to extend the Final Expiration Date by an additional three years,
to September 19, 2008. As of June 30, 2005, we entered into an amendment to the Rights Agreement with the Rights Agent reflecting
such extension. No other changes were made to the terms of the Rights or the Rights Agreement at that time. On June 6, 2008 our
Board voted to authorize an amendment of the Rights Agreement to extend the Final Expiration Date by an additional three years,
to September 19, 2011 and to increase the ownership threshold for determining “Acquiring Person” status from 15% to
18%. As of June 30, 2008, we entered into an amendment to the Rights Agreement with the Rights Agent reflecting such extension
and threshold increase. No other changes were made to the terms of the Rights or the Rights Agreement at that time. On August
5, 2011, our Board voted to authorize amendments of the Rights Agreement to extend the Final Expiration Date by an additional
three years to September 19, 2014 and to increase the ownership threshold for determining “Acquiring Person” status
from 18% to 20%. As of August 9, 2011, we entered into an amendment to the Rights Agreement with the Rights Agent reflecting such
extension and threshold increase. No other changes have been made to the terms of the Rights or the Rights Agreement.



Our Board of Directors
believes that there is some risk that the potential value of the Mast Out® product development initiative
may not be fairly reflected in the market price of our common stock, as it fluctuates from time to time, and that opportunistic
buyers could take advantage of that disparity to the detriment of our stockholders. If this were to happen and result in a potential
threat through an unsolicited acquisition effort or otherwise, our Board feels that the Rights Plan could enhance stockholder value
by providing management with negotiating leverage.



| | 10. | COMMITMENTS AND CONTINGENT LIABILITIES
| | --- | --------------------------------------



Our By-Laws, as amended,
in effect provide that the Company will indemnify its officers and directors to the maximum extent permitted by Delaware law. In
addition, we make similar indemnity undertakings to each director through a separate indemnification agreement with that director.
The maximum payment that we may be required to make under such provisions is theoretically unlimited and is impossible to determine.
We maintain directors’ and officers’ liability insurance, which may provide reimbursement to the Company for payments
made to, or on behalf of, officers and directors pursuant to the indemnification provisions. Our indemnification obligations were
grandfathered under the provisions of Codification Topic 460, Guarantees. Accordingly, we have recorded no liability for
such obligations as of December 31, 2011. Since our incorporation, we have had no occasion to make any indemnification payment
to any of our officers or directors for any reason.



We enter into agreements
with third parties in the ordinary course of business under which we are obligated to indemnify such third parties for and against
various risks and losses. The precise terms of such indemnities vary with the nature of the agreement. In many cases, we limit
the maximum amount of our indemnification obligations, but in some cases those obligations may be theoretically unlimited. We have
not incurred material expenses in discharging any of these indemnification obligations, and based on our analysis of the nature
of the risks involved, we believe that the fair value of these agreements is minimal. Accordingly, we have recorded no liabilities
for these obligations as of December 31, 2011.



The development, manufacturing
and marketing of animal health care products entails an inherent risk that liability claims will be asserted against us. We feel
that we have reasonable levels of liability insurance to support our operations.



F-16







ImmuCell Corporation



Notes to Audited Financial Statements
(continued)





| | 11. | SEGMENT AND SIGNIFICANT CUSTOMER INFORMATION
| | --- | --------------------------------------------



We principally operate
in the business segment described in Note 1. Pursuant to Codification Topic 280, Segment Reporting, we operate in one reportable
business segment, that being the development, acquisition, manufacture and sale of products that improve the health and productivity
of cows for the dairy and beef industries. Almost all of our internally funded product development expenses are in support of such
products. The significant accounting policies of this segment are described in Note 2.



Our primary customers
for the majority of our product sales (81%, 82% and 78% for the years ended December 31, 2011, 2010 and 2009, respectively) are
in the U.S. dairy and beef industries. Product sales to international customers, who are also in the dairy and beef industries,
aggregated 17%, 15% and 19% of our total product sales for the years ended December 31, 2011, 2010 and 2009, respectively. Sales
to significant customers that amounted to 10% or more of total product sales are detailed in the following table:





|                                     |  | Year Ended December 31, |   
|------------------------------------ |  | ----------------------- | --
|                                     |  | 2011                    |   
|Animal Health International, Inc.(1) |  |                         | 38
|MWI Veterinary Supply Company(2)     |  |                         | 14





(1) Assumes that the June 2011 acquisition of Animal Health
International by Lextron had occurred as of the beginning of the periods being reported.

(2) Assumes that the March 2011 acquisition of Nelson Laboratories
and the October 2011 acquisition of Micro Beef Technologies by MWI had occurred as of the beginning of the periods being reported.



Accounts receivable due from significant
customers amounted to the percentages of total trade accounts receivable as detailed in the following table:





|                                     |  | As of December 31, |   
|------------------------------------ |  | ------------------ | --
|                                     |  | 2011               |   
|Animal Health International, Inc.(1) |  |                    | 23
|MWI Veterinary Supply Company(2)     |  |                    | 21
|Stearns Veterinary Outlet, Inc.      |  |                    | 18
|Robert J. Matthews Company           |  |                    | * 







*Amount is less than 10%.



(1) Assumes that the June 2011 acquisition of Animal Health
International by Lextron had occurred as of the dates being reported.

(2) Assumes that the March 2011 acquisition of Nelson Laboratories
and the October 2011 acquisition of Micro Beef Technologies by MWI had occurred as of the dates being reported.



| | 12. | RELATED PARTY TRANSACTIONS
| | --- | --------------------------



Dr. David S. Tomsche (a member of our Board
of Directors) is a controlling owner of Stearns Veterinary Outlet, Inc., a domestic distributor of ImmuCell products (First
DefenseÒ, Wipe OutÒ
Dairy Wipes,andCMT) and of J-t Enterprises of Melrose, Inc., an exporter. His affiliated companies purchased
approximately $295,000, $288,000 and $283,000 of products from ImmuCell during the years ended December 31, 2011, 2010 and 2009,
respectively, on terms consistent with those offered to other distributors of similar status. Our accounts receivable (subject
to standard and customary payment terms) due from these affiliated companies aggregated approximately $61,000 and $45,000 as of
December 31, 2011 and 2010, respectively.



F-17









ImmuCell Corporation



Notes to Audited Financial Statements
(continued)





| | 13. | EMPLOYEE BENEFITS
| | --- | -----------------



We have a 401(k) savings
plan in which all employees completing one year of service with the Company (working at least 1,000 hours) are eligible to participate.
Participants may contribute up to the maximum amount allowed by the Internal Revenue Service. We match 50% of each employee’s
contribution to the plan up to a maximum match of 4% of each employee’s base compensation. Under this matching plan, we paid
approximately $48,000, $41,000 and $40,000 to the plan for the years ended December 31, 2011, 2010 and 2009, respectively.



| | 14. | UNAUDITED QUARTERLY FINANCIAL DATA
| | --- | ----------------------------------



The following tables present
the quarterly information for fiscal years 2011, 2010 and 2009 (in thousands, except per share amounts):



|                                    |  | Three Months Ended |      
|----------------------------------- |  | ------------------ | -----
|                                    |  | March  31          |      
|                                    |  |                    |      
|Fiscal 2011:                        |  |                    |      
|Product sales                       |  | $                  | 1,556
|Gross margin                        |  |                    | 868  
|Product development expenses        |  |                    | 472  
|Net operating income (loss)         |  |                    | (17  
|Income (loss) before income taxes   |  |                    | (31  
|Net income (loss)                   |  |                    | (23  
|Net income (loss) per common share: |  |                    |      
|Basic                               |  | $                  | (0.01
|Diluted                             |  | $                  | (0.01
|                                    |  |                    |      
|Fiscal 2010:                        |  |                    |      
|Product Sales                       |  | $                  | 1,311
|Gross margin                        |  |                    | 739  
|Product development expenses        |  |                    | 405  
|Net operating loss                  |  |                    | (74  
|Loss before income taxes            |  |                    | (65  
|Net loss                            |  |                    | (53  
|Net loss per common share:          |  |                    |      
|Basic                               |  | $                  | (0.02
|Diluted                             |  | $                  | (0.02
|                                    |  |                    |      
|Fiscal 2009:                        |  |                    |      
|Product Sales                       |  | $                  | 1,460
|Gross margin                        |  |                    | 721  
|Product development expenses        |  |                    | 432  
|Net operating loss                  |  |                    | (74  
|Loss before income taxes            |  |                    | (36  
|Net loss                            |  |                    | (35  
|Net loss per common share:          |  |                    |      
|Basic                               |  | $                  | (0.01
|Diluted                             |  | $                  | (0.01



| | 15. | SUBSEQUENT EVENTS
| | --- | -----------------



We have adopted the disclosure
provisions of Codification Topic 855-10-50-1, Subsequent Events, which provides guidance to establish general standards
of accounting for and disclosures of events that occur after the balance sheet date but before financial statements are issued.
Entities are required to disclose the date through which subsequent events were evaluated as well as the rationale for why that
date was selected. This disclosure should alert all users of financial statements that an entity has not evaluated subsequent events
after that date in the set of financial statements being presented. Codification Topic 855-10-50-1 requires additional disclosures
only, and therefore did not have an impact on our financial condition, results of operations, earnings per share or cash flows.
Public entities must evaluate subsequent events through the date that financial statements are issued. Accordingly, we have evaluated
subsequent events through the time of filing on March 27, 2012, the date we have issued this Annual Report on Form 10-K.



F-18







ImmuCell Corporation



Signatures



In accordance with Section
13 or 15(d) of the Exchange Act, the Registrant caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.



|                           |     |                        | IMMUCELL CORPORATION                                                       
|-------------------------- | --- | ---------------------- | ---------------------------------------------------------------------------
|                           |     |                        |                                                                            
|Date:      January 8, 2013 | By: | /s/ Michael F. Brigham
|                           |     |                        | Michael F. Brigham
        President, Chief Executive Officer and Treasurer



POWER OF ATTORNEY



We, the undersigned directors
and officers of ImmuCell Corporation hereby severally constitute and appoint Michael F. Brigham our true and lawful attorney-in-fact
and agent, with full power of substitution and resubstitution, for us and in our stead, in any and all capacities, to sign any
and all amendments to this report and all documents relating thereto, and to file the same, with all exhibits thereto, and other
documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent,
full power and authority to do and perform each and every act and thing necessary or advisable to be done in and about the premises,
as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact
and agent, or his substitute or substitutes, may lawfully do or to be done by virtue hereof.



In accordance with the
Exchange Act, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and
on the dates indicated.



|Date:      January 8, 2013 | By: | /s/ Michael F. Brigham    
|-------------------------- | --- | --------------------------
|                           |     |                           
|                           |     |                           
|Date:      January 8, 2013 | By: | /s/ Joseph H. Crabb       
|                           |     |                           
|                           |     |                           
|Date:      January 8, 2013 | By: | /s/ David S. Cunningham   
|                           |     |                           
|                           |     |                           
|Date:      January 8, 2013 | By: | /s/ William H. Maxwell    
|                           |     |                           
|                           |     |                           
|Date:      January 8, 2013 | By: | /s/ Linda Rhodes          
|                           |     |                           
|                           |     |                           
|Date:      January 8, 2013 | By: | /s/ Jonathan E. Rothschild
|                           |     |                           
|                           |     |                           
|Date:      January 8, 2013 | By: | /s/ David S. Tomsche      
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ImmuCell Corporation



EXHIBIT INDEX



|Exhibit 23* | Consent of Baker Newman & Noyes, LLC                                                                        
|----------- | ------------------------------------------------------------------------------------------------------------
|            |                                                                                                             
|Exhibit 31* | Certifications required by Rule 13a-14(a)                                                                   
|            |                                                                                                             
|Exhibit 32  | Certification pursuant to Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002



* Revised Filing.