Back to GetFilings.com
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 1997
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
0-15507
(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, including area code: (207) 878-2770
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Name of each exchange on which registered
- ------------------- -----------------------------------------
Common Stock, par value $.10 per share Boston Stock Exchange
Common Stock Purchase Rights Boston Stock Exchange
Securities registered pursuant
to Section 12(g)of the Act: Common Stock par value $.10 per share
-------------------------------------
(Title of class)
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 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. [ ]
The aggregate market value of the Common Stock held by non-affiliates of the
Registrant at March 18, 1998 was approximately $4,281,000.
The number of shares of the Registrant's Common Stock outstanding at March 18,
1998 was 2,420,884.
Documents incorporated by reference: Portions of the Registrant's 1998 Proxy
Statement to be filed in connection with the Annual Meeting of shareholders are
incorporated by reference to Part III hereof.
TABLE OF CONTENTS
-----------------
PART I
ITEM 1. Business .........................................................1
ITEM 2. Properties........................................................8
ITEM 3. Legal Proceedings.................................................9
ITEM 4. Submission of Matters to a Vote of Security Holders...............9
PART II
ITEM 5. Market for Registrant's Common Equity and Related Stockholder
Matters...........................................................9
ITEM 6. Selected Financial Data...........................................9
ITEM 7. Management's Discussion and Analysis of Financial Condition
and Results of Operations........................................10
ITEM 8. Financial Statements and Supplementary Data......................15
ITEM 9. Changes in and Disagreements with Accountants on Accounting
and Financial Disclosure.........................................15
PART III
ITEM 10. Directors and Executive Officers of the Registrant.............. 15
ITEM 11. Executive Compensation...........................................16
ITEM 12. Security Ownership of Certain Beneficial Owners and Management...16
ITEM 13. Certain Relationships and Related Transactions...................16
PART IV
ITEM 14. Exhibits, Financial Statement Schedules and Reports on Form
8-K..............................................................17
SIGNATURES
PART I
ITEM 1 - BUSINESS
General
ImmuCell Corporation (the "Company") is a biotechnology company that
primarily develops, manufactures and markets milk-derived passive antibody
products to prevent and/or treat gastrointestinal infections in both humans and
animals. Using its core technology, the Company has developed proprietary
methods for the production of commercial quantities of pathogen-specific
antibodies from cows' milk. First Defense {}, which has been
approved by the United States Department of Agriculture ("USDA"), is the first
product using this technology to be commercialized by the Company. Currently,
this product is the only USDA-licensed, bivalent (effective in combatting two
different infectious agents) scours preventive product in capsule form
available on the market. The Company is investing in research and development
that could lead to the commercialization of new products incorporating these
proprietary methods for the prevention and/or treatment of gastrointestinal
infections in humans.
From its inception in 1982, the Company has engaged in the research and
development of both infectious disease diagnostic tests and products for
therapeutic and preventive uses against certain infectious diseases in
animals and humans. Since 1991, this product development effort has focused
more principally on the prevention and treatment of gastrointestinal
infections. Recently, the Company has diversified its product development
pipeline in two significant ways. First, the Company has utilized the
knowledge gained developing a product to treat and/or prevent a
gastrointestinal infection caused by Cryptosporidium Parvum to develop a method
to detect the presence of this dangerous parasite in public water supplies.
Secondly, the Company has utilized both its expertise in processing proteins
from cows' milk and its exclusive world-wide license to certain purification
technology to develop a process to separate specialty proteins from cheese
whey.
Research and development expenditures amounted to 23% of total revenues
in 1997. For the Company to benefit from the growth that the successful
introduction of new products may create, the Company intends to continue to
invest a significant portion of revenues in research and development, which
investment could lead to a loss in 1998, which loss could be funded from cash
reserves. In addition, the Company intends to actively pursue licensing
opportunities with corporate partners and funding from government grants to
support research and development expenditures in 1998 and beyond. The amount
of the 1998 profit or loss can not be accurately predicted because of
uncertainties in obtaining corporate partner funding.
Two Milk Antibody Products Under Development
The Company currently has two bovine-derived specific polyclonal antibody
products under clinical development that are subject to approval by the U.S.
Food and Drug Administration ("FDA") before sales can be initiated. These
products are as follows:
1) TravelGAM{TM} bovine anti-E. coli immunoglobulins: TravelGAM is
intended to prevent diarrhea caused by enterotoxigenic E. coli (commonly known
as Travelers' Diarrhea). Unlike First Defense, one of the Company's animal
health products, which is produced from hyperimmunized cows' colostrum, this
product is produced from hyperimmunized cows' milk.
Under an Investigational New Drug ("IND") application approved by the
FDA, the Company completed a successful Phase I/II challenge/protection trial
of this product in June 1995. This clinical trial was performed at the Center
for Vaccine Development at the University of Maryland at Baltimore in
approximately 25 patients and demonstrated a 90% protection rate. The results
of this study were published in the March 1998 issue of the Journal of
Infectious Diseases. In 1996, the Company performed additional testing to
optimize the dose size and delivery format of the product.
In 1997, the Company entered into a Cooperative Research and Development
Agreement with the U.S. Navy to conduct a Phase II, double blind, placebo
controlled field study of TravelGAM{TM} to examine the effectiveness of the
product in preventing the onset of E. coli-associated diarrhea among
participants in a multinational military exercise conducted in the Middle East.
The preliminary results of this study became available in March 1998 but were
inconclusive.
The study design was based on historical attack rates in and around the
region of the troop deployment and called for the evaluation of 400 subjects to
be distributed equally among one placebo and two treatment groups. However,
due to difficulties in recruiting volunteers, only 68 subjects met the
enrollment criteria in full. Of the 68 subjects that could be evaluated, 24
fell into the randomly selected placebo group. Only 1 out of these 24 patients
developed diarrhea. Two out of 21 subjects in one of the treatment arms and 3
out of 23 subjects in the other also contracted the disease. An additional 132
recruits met expanded entry criteria, but proved to be at low risk for
contracting E. coli-associated diarrhea; consequently, few cases of diarrhea
were observed in this group. The low overall enrollment in the study, coupled
with the low incidence of diarrhea in the placebo group, materially weakened
any statistical inferences that could be drawn from the study. Therefore,
conclusive determination of the product's effectiveness could not be made based
on the available data.
In 1998, the Company intends to perform another hospital-based,
challenge/protection study to determine the product's effectiveness under
simulated field conditions. A federal research grant from the National
Institutes of Health (described below) should provide significant funding for
this study. If results of this 1998 study are positive, the Company would
intend to perform a hospital-based, dose-ranging trial to determine the optimal
dose size before performing a Phase III field trial in mid 1999. A marketing
partner or other outside source of funding would be needed to provide the
required funding for such a Phase III trial.
2) DiffGAM{TM} bovine anti-Clostridium difficile imunoglobulins:
DiffGAM is intended to prevent and/or treat Clostridium Difficile-associated
diarrhea ("CDAD") that is caused by toxin-producing Clostridium Difficile.
DiffGAM is intended to neutralize the toxins produced by Clostridium difficile
in the colons of at-risk patients. CDAD is most frequently caused by the use
of broad spectrum oral antibiotics and is then treated with antibiotics
specific for Clostridium difficile. This standard of treatment can lead to
high rates of relapse and the development of antibiotic resistance. The
Company believes that DiffGAM may provide a safe alternative to the current
methods used to treat CDAD. As is the case with TravelGAM, this product is
produced from hyperimmunized cows' milk.
The 1997 DiffGAM development effort included FDA approval of an IND
application in March, under which a clinical trial was conducted demonstrating
the safety of DiffGAM and the colonic bioavailability of the current DiffGAM
formulation.
Clinical development of a third product, CryptoGAM bovine anti-
Cryptosporidium immunoglobulins, was discontinued in 1997, and the Company's
collaborative agreement to develop this product with the Center for Special
Immunology, Inc. of Fort Lauderdale, Florida was terminated. These decisions
were made principally because the targeted patient population is materially
decreasing due to the positive impact that new drugs are having on AIDS
patients. CryptoGAM was intended to treat chronic, life-threatening diarrhea
(known as cryptosporidiosis) in AIDS patients.
The Company has obtained four Phase I Small Business Innovation Research
("SBIR") grants and three Phase II SBIR grants from the National Institutes of
Health to support the development of milk antibody products to prevent
gastrointestinal infections in humans. The value of these grants has
aggregated approximately $1,891,000 since 1990, $200,000 of which was
recognized in 1997 and $510,000 of which is expected to be recognized in 1998
and 1999.
Two Joint Ventures
1) Clearwater Diagnostics Company, LLC: To capitalize on certain
scientific knowledge gained under the CryptoGAM research program described
above, the Company formed a joint venture with Membrex, Inc. of Fairfield, NJ
("Membrex") to commercialize the combination of certain detection technology
developed by the Company with certain concentration technology owned by Membrex
into a diagnostic test to detect Cryptosporidium parvum oocysts and other
microorganisms in water. This product is known as the Crypto-Scan{TM} water
diagnostic test.
The Company has a 50% ownership interest in this joint venture and is
entitled to 50% of the joint venture's profits from the sales of its products
for water industry applications. Beginning in the third year of commercial
sales, this right to profits is reduced to 45%. The Company is also entitled
to 10% of the joint venture's profits from the sale of its products for food
and beverage applications.
Initial and limited sales of Crypto-Scan began in 1997. The technology
is being evaluated by the U.S. Environmental Protection Agency ("EPA") under a
study known as "Method 1622". Significant sales are not expected until and
unless the results of this EPA study endorse the use of Crypto-Scan by U.S.
public water utilities. During 1997, the Company entered into a distribution
agreement with Adreck Marketing Limited covering the United Kingdom. Initial
sales in the U.K. have been limited as the distributor is working to introduce
this new technology to U.K. water utilities.
The Company obtained a $100,000 Phase I SBIR grant in September 1996 to
complete the development of the water test and to partially fund the design of
a commercial prototype machine. Approximately half of this grant income was
recognized in 1996, and the remaining half was recognized in 1997.
2) AgriCell Company, LLC ("AgriCell"): To capitalize on the Company's
milk protein purification experience, the Company and Agri-Mark Inc. of
Methuen, MA ("Agri-Mark") formed a joint venture to produce and sell a
nutritional protein, known as lactoferrin, from cheese whey. Lactoferrin is an
iron-binding protein that, among several applications, can be used in infant
formula and certain cosmetics. In 1997, AgriCell commissioned a 6,800 square
foot production facility at Agri-Mark's cheese plant in Middlebury, Vermont
which was subsequently approved by the USDA, allowing commercial production of
lactoferrin to be initiated. Initial sales of lactoferrin have been extremely
limited. Sales have been negatively impacted by the Asian financial crisis.
Korea is a primary market for this product.
The Company has a 50% ownership interest in this joint venture and is
entitled to 50% of the joint venture's profits from the sale of lactoferrin
after Agri-Mark has obtained the return of an amount equal to its invested
capital. Agri-Mark is funding a capital investment by AgriCell of
approximately $1,000,000 in principally working capital, fixed assets and
production facility modifications, and Agri-Mark is entitled to a 90% priority
return until it obtains the return of an amount equal to this invested capital.
Additionally, Agri-Mark has the right to utilize the Company's technology to
produce whey protein isolate from Agri-Mark's Vermont cheese whey source. The
Company is entitled to a royalty on any such sales.
Commercialization of Milk Protein Purification Technology
Underlying the Company's milk antibody products for human and animal
health care applications is a certain expertise developed by the Company to
process and purify milk proteins. This expertise and rights to a patented
purification system to which the Company holds a world-wide, exclusive license
for all milk and whey protein applications have been licensed to AgriCell for
use in the production of lactoferrin. In addition, in November 1997, the
Company received a $250,000 license payment from Murray Goulburn Co-operative
Co., Limited of Australia for rights to use this technology for the production
of certain food ingredients, such as whey protein isolate and certain other
proteins (excluding lactoferrin). The Company is entitled to a royalty on
sales of whey protein isolate and any other applicable proteins under this
license. Because the construction and installation of the required facility
and equipment by Murray Goulburn is not expected to be complete before the end
of 1998, royalties are not anticipated to begin until late 1998 or 1999.
Development of Lower Cost Manufacturing Process
Cost will be a significant factor in determining market acceptance of the
Company's products. Although antibody concentrations are much higher in a
cow's first milk, or colostrum, more total antibodies are available in milk
than in colostrum. Although colostrum has a very rich antibody content, it
contains less than 20% of the total antibodies produced by a cow during each
lactation cycle. For this reason, the Company has developed a purification
process that allows the Company to harvest antibodies from a cow's entire
lactation cycle, as opposed to only from the cow's colostrum. The Company
believes this milk purification process may create a significant product cost
advantage.
Dairy and Beef Animal Health Products
In 1988, the Company obtained an exclusive world-wide license to purchase
from Kamar, Inc. of Steamboat Springs, Colorado ("Kamar") and to market and
sell an animal health care product known as the Kamar
Heatmount{TM} Detector. This product is used to detect the physical mounting
of bovines for the determination of standing heat, and is sold primarily to
dairy farmers. In December 1993, the Company entered into a renewal of its
service and license agreement effective through December 31, 1999 with Kamar
whereby Kamar will continue to provide the Company warehousing, distribution
and certain other services and the Company will continue to market the Kamar
Heatmount Detector under an exclusive world-wide license. The renewal
agreement is cancelable by either party upon twelve months written notice.
Continuation of this license is an important element of the Company's strategy
to maintain and grow animal health product sales.
In 1991, the Company obtained approval from the U.S. Department of
Agriculture to sell First Defense, which is manufactured by
the Company from cows' colostrum using the Company's proprietary vaccine and
processing technology. The target disease, "calf scours", is seasonal, with
the highest incidence in the winter calving months. This diarrheal disease
causes dehydration in newborn calves and often leads to serious sickness and
even death.
Other Products
The Company also markets the following animal health care products: 1)
RPT and Accufirm, tradenames for a milk progesterone test used by dairy farmers
to monitor the reproductive status of their cows and 2) RJT, used in the
detection of Mycobacterium paratuberculosis infections (Johne's Disease) in
cattle. Sales of these products have been limited since their commercial
introductions. These products are not a significant focus of the Company's
future.
As an extension of its expertise with infectious diseases, the Company
manufactures immunodiagnostic reagents for certain human infectious disease
diagnostic products. Subject to a royalty bearing licenses, the Company
manufactures and sells specific antibody-based reagents used for: 1) the
diagnosis of Group A streptococcal infections, a bacterial infection which
causes "strep throat" and 2) the detection of Group B Streptococcus bacterial
infections that cause sepsis and meningitis in newborn infants. Sales of these
reagents declined significantly in 1997. Future sales of the Group B reagents
are not expected to be material.
While the Company continues its efforts with internally and externally
funded product development programs, the Company is also actively seeking to
enter into licenses to sell new products and technologies.
Marketing and Sales
The Company engages in the direct marketing and sales of its products
principally through its marketing subsidiary, Kamar Marketing Group, Inc. Like
many small manufacturers, the Company sells its animal health products through
large and well known distributors. The manner in which the Company's products
are marketed and distributed depends in large measure upon the nature of the
particular product, its intended users and the country where it is sold. The
distribution channel selected is intended to address the particular
characteristics of the marketplace for a given product. For example, First
Defense is primarily sold through major veterinarian
distributors, and the Kamar Heatmount Detector is sold through bovine semen
distributors. Separate agreements have been entered into for sales through
these distribution channels.
Foreign Sales
Foreign product sales represented approximately 28%, 27% and 20% of the
Company's total product sales for the years ended December 31, 1997, 1996 and
1995, respectively. The majority of these foreign sales were to European
countries, Australia, New Zealand and Canada. It is anticipated that a
significant amount of the Company's future sales will continue to be made
outside of the United States.
The Company currently prices most of its products in United States
dollars. An increase in the value of the dollar in any foreign country in
which the Company's products are sold may have the effect of increasing the
local price of such products, thereby leading to a reduction in demand.
Similarly, to the extent that the value of the dollar may decline with respect
to a foreign currency, the Company's competitive position may be enhanced.
Core Technology - Passive Immunoprevention
Enteric infections (infections of the gastrointestinal, or GI, tract)
often result from the unchecked growth of pathogenic microorganisms that enter
the body orally. It is possible to augment the gut-associated immune system by
supplying adequate amounts of the desired protective antibodies by oral
feeding. These externally supplied antibodies function in the GI tract
offering passive protection from the invading pathogen and thereby augmenting
intestinal secretory immunity. ImmuCell's core technology is directed toward
the efficient production and formulation of such antibodies used to prevent
and/or treat gastrointestinal infections. The Company's business strategy is
to commercialize applications of this technology for a portfolio of
specifically targeted antibody products derived from cows' milk.
Orally administered bovine antibodies have been shown to be effective in
preventing infection in numerous studies and can be formulated either as
traditional biologicals or as food additives. Since they are derived from
milk, these products are non-toxic and are inherently safe. In addition, these
products can be produced economically at a commercial scale. The Company
believes that these features could facilitate acceptance of products targeted
at both human and animal health care markets.
When humans or animals are exposed to microorganisms such as bacteria,
viruses or parasites, specific cells of the immune system (T-cells and B-cells)
are activated to eliminate the invading pathogen. Antibodies, which are
protein products of specifically activated B-cells, serve as a front line of
immune defense against infectious diseases. Present in a variety of body
fluids including blood, milk, saliva and intestinal fluids, antibodies are
highly selective in recognizing structural components or antigens present on
foreign microbes. Through attachment to various microbial antigens, antibodies
serve to block infectious invasion and to mark their targets for removal by
cellular elements of the immune system. This ability of antibodies to
specifically recognize and bind with antigens is the basis of the
immunochemical technology employed by the Company.
Passive immune protection is a natural biological phenomenon: all
mammals provide antibodies to their young during nursing. These orally
supplied antibodies are contained in the natural food of newborns - mothers'
milk. The presence of certain antibodies can be increased in response to an
immunization with a specific vaccine. The Company has developed an expertise
in developing such proprietary vaccines. These custom vaccines are used in the
Company's proprietary hyperimmunization programs of its donor cows. The
Company's disease-prevention technology utilizes antibodies (produced by such
vaccinated cows and isolated from their milk) that are delivered orally to
prevent and/or treat gastrointestinal infections.
Once the body has "learned" to make specific antibodies, it is, to a
certain degree, prepared to provide protection against subsequent infection by
the original microbe or pathogen. This is why mature, healthy humans and
animals can produce antibodies to these disease-causing organisms. However,
sometimes the body is unable to produce the antibodies necessary to
"neutralize" an infectious pathogen, leaving the body susceptible to disease
caused by that pathogen such as in the following cases : 1) newborn animals
and humans whose immune systems are not fully functional, 2) adults whose
immune systems are under stress or have been damaged or destroyed by disease
(immunocompromised) and 3) adults who have never been exposed to a particular
pathogen through natural infection or vaccination. For example, newborn calves
that do not receive maternal colostrum (first milk) do not have antibodies to
protect themselves. Additionally, persons with nonfunctional immune systems
are at risk from a variety of common pathogens to which they cannot mount an
immune response, as are travelers to geographic areas where new microbial
pathogens are encountered.
Research and Development
The Company's research and development activities are aimed primarily at
the development of new commercial products, incorporating the Company's
proprietary technology and manufacturing methods, for the prevention of
gastrointestinal infections in humans. The Company's research and development
activities are conducted internally and through contracts with third parties
depending upon the availability of staff, the technical skills required, the
nature of the particular project and other considerations. As additional
opportunities to commercialize the Company's immunochemistry technology become
apparent, the Company may begin new research and development projects. The
Company spent approximately $1,068,000, $1,291,000 and $1,578,000 on research
and development activities during the years ended December 31, 1997, 1996 and
1995, respectively. These expenditures were in part supported by collaborative
research and development revenue and grant income totaling approximately
$249,000, $386,000 and $587,000 during the years ended December 31, 1997, 1996
and 1995, respectively.
The Company is seeking partners to fund research and development
activities on certain projects in exchange for distribution rights to the
resulting products. The Company has gained access to certain new technologies
and capital by assigning certain of its proprietary technologies to joint
ventures with corporate partners to jointly develop and commercialize new
products. Federal research grants have contributed significant funding to the
research and development efforts underwritten principally by the Company. The
Company has also sold certain proprietary technology rights to corporate
partners in return for future royalties on sales. The Company maintains
relationships with several scientific advisors that have particular expertise
in the areas targeted by the Company.
Competition
The Company's competition in the animal and human health care markets
includes other biotechnology companies, major pharmaceutical firms and food and
chemical companies. Many of these competitors have substantially greater
financial, marketing, manufacturing and human resources and more extensive
research and development facilities than the Company. Many of these
competitors may develop technologies and/or products which are superior to
those of the Company, or may be more successful in developing production
capability or in obtaining certain regulatory approvals. GalaGen is developing
a colostrum-derived antibody product to prevent Clostridium Difficile-
associated diarrhea. Synsorb Biotech, Inc. and Ophidian Pharmaceuticals, Inc.
are both also developing products to prevent Clostridium Difficile-associated
diarrhea. The Company believes that its competitive position will be highly
influenced by its 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 raise adequate levels of capital to fund
its activities.
The Company believes that First Defense offers two
significant competitive advantages over other products in the market: 1) its
capsule form, which does not require refrigeration, provides ease of
administration by the farmer, and 2) competitive products currently on the
market provide protection against the leading cause of calf scours, while First
Defense provides this protection and additional protection against the second
leading cause of the disease. Recently, competitive companies have introduced
products similar to the Kamar Heatmount{TM} Detector. The
success of these products could reduce sales of the Company's product.
The Company believes that supplies and raw materials for the production
of its products are readily available from a number of vendors and farms. It
is the Company's policy to maintain several sources of supply for the
components used in the Company's products.
The Company currently competes on the basis of product performance, price
and distribution capability. The Company has expanded and continues to seek to
expand its network of independent distributors to improve its competitive
position.
Patents and Proprietary Information
In 1997, the Company received notice of allowance for two patent
applications from the U.S. Patent and Trademark Office. The first covers
certain aspects of the Company's proprietary manufacturing process to separate
antibodies from cows' milk used in production of TravelGAM{TM} and DiffGAM{TM}.
The second covers certain aspects of the method used to detect Cryptosporidium
parvum in drinking water supplies. A separate patent application covering a
different aspect of this water test has also been filed by the Company. The
rights to the Cryptosporidium parvum patent applications have been assigned to
the Company's joint venture, Clearwater Diagnostics Company, LLC. In early
1998, the Company submitted a patent application covering the product
formulation used to deliver DiffGAM to the site of the targeted infection.
Going forward, the Company 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.
The Company has licensed exclusively the right to use certain milk
purification technology for the processing of immunoglobulins, which technology
is the subject matter of one or more patents owned or controlled by the
Wisconsin Alumni Research Foundation. The Company has also licensed
exclusively the right to use a purification system used by the Company to
manufacture specialty proteins from cows' milk, which is the subject matter of
one or more patents owned or controlled by Advanced Separations Technologies,
Inc. The Company has also licensed exclusively rights to certain cloned
antigens of Cryptosporidium parvum from the Regents of the University of
California, for which a U.S. patent was issued to the Regents in 1997. This
license covers passive antibody and vaccine product applications for animals
and passive antibody product applications for humans. The method developed by
the Company to detect Cryptosporidium parvum in water supplies includes certain
technology developed by Membrex, Inc., which is the subject of several issued
patents which have been assigned to the Company's joint venture, Clearwater
Diagnostics Company, LLC.
In some cases, the Company has chosen and may choose in the future not to
seek patent protection for certain products or processes. Instead, the Company
has sought and may seek in the future to maintain the confidentiality of any
relevant proprietary technology. Reliance upon trade secret, rather than
patent protection, may cause the Company to be vulnerable to competitors who
successfully replicate the Company's 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 the Company's
unpatented trade secrets or proprietary technology. This is particularly true
if the Company enters into joint ventures or other arrangements with respect to
its products, including the manufacture thereof. All of ImmuCell's employees
are required to execute nondisclosure and invention assignment agreements
designed to protect the Company's rights in its proprietary products.
Other companies may have filed patent applications and may have been
issued patents involving products or technologies potentially useful to the
Company or necessary for the Company to commercialize its products or achieve
its business goals. There can be no assurance that the Company will be able to
obtain licenses of such patents on terms acceptable to the Company.
Trademarks
The Company has registered certain trademarks with the U.S. Patent and
Trademark Office in connection with the marketing of its products. The Company
has obtained registration of the trademark, First Defense, for
one of its animal health products. The Company has applied for federal
trademark registration for and intends to use the following marks in
conjunction with the marketing of its products: Crypto-Scan{TM} water
diagnostic test, TravelGAM{TM} bovine anti-E. coli immunoglobulins and
DiffGAM{TM} bovine anti-Clostridium difficile immunoglobulins.
Government Regulation
The manufacture and sale of some of the Company's animal health care
products within the United States is regulated by the USDA. The manufacture
and marketing of disease treatment and prevention products for human medical
applications within the United States is subject to regulation by the FDA.
Comparable agencies exist in foreign countries and foreign sales of the
Company's products will be subject to regulation by such agencies. Many states
(including Maine where the Company's laboratory and production facilities are
located) have laws regulating the production, sale, distribution or use of
biological products, and the Company may have to obtain approvals from
regulatory authorities in states in which it proposes to sell its products.
Depending upon the product and its applications, obtaining USDA and other
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.
The Company has received USDA approval for First Defense (its scours
preventive product) and RJT (its Johne's Disease diagnostic test). Two of the
Company's new products under development, TravelGAM (to prevent diarrhea in
travelers) and DiffGAM (to prevent Clostridium difficile-associated diarrhea)
are in FDA Phase I/II clinical trials under approved Investigational New Drug
("IND") applications. The Company believes that it is in compliance with
current USDA and FDA regulatory requirements relating to the Company's business
and products.
Product Liability
The manufacture and marketing of certain of the Company's products
entails a risk of product liability. The Company's current exposure to product
liability is mitigated to some extent by the fact that the Company's current
products have heretofore been principally directed towards the animal health
care market. The Company has maintained product liability insurance in an
amount which it believes is adequate to cover its potential exposure in this
area.
Employees
The Company and its wholly-owned subsidiary, the Kamar Marketing Group,
Inc., currently employ the full-time equivalent of approximately twenty-two
employees. Seven and one-half employees are engaged in research and
development activities, nine in manufacturing, four in finance and
administration, and one and one-half in marketing and sales. The manufacturing
personnel is utilized, as needed, in the production of clinical material for
use in research and development. The Company is not a party to any collective
bargaining agreement and considers its employee relations to be excellent.
ITEM 2 - PROPERTIES
The Company owns a 10,000 square foot building at 56 Evergreen Drive in
Portland, Maine. Initially, this facility was used for the Company's
administrative and research and development needs. In March 1996, the Company
consolidated its manufacturing and warehouse operations into this building.
Facility modifications and improvements necessary to complete this
consolidation and associated capital equipment expenditures aggregated
approximately $400,000. The Company currently uses the space for substantially
all of its office, laboratory and manufacturing needs.
The Company also maintains access to certain animals, primarily cows,
through contractual relationships with several farms. The Company believes
that these facilities are adequate for all current and projected needs.
ITEM 3 - LEGAL PROCEEDINGS
None
ITEM 4 - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
PART II
ITEM 5 - MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS
The Company's common stock trades on The Nasdaq SmallCap Market tier of
The Nasdaq Stock Market under the symbol: ICCC. The Company's common stock is
also listed for trading on the Boston Stock Exchange under the symbol: IMU.
No dividends have been declared or paid on the common stock since its
inception, and the Company does not contemplate the payment of cash dividends
in the foreseeable future.
The following table sets forth the high and low sales price information
for ImmuCell's common stock as reported by The Nasdaq Stock Market during the
period January 1, 1996 through December 31, 1997:
1997 1996
1ST QTR. 2ND QTR. 3RD QTR. 4TH QTR. 1ST QTR. 2ND QTR. 3RD QTR. 4TH QTR.
High $2.94 $3.25 $3.13 $3.38 $6.13 $4.88 $3.63 $3.63
Low $2.13 $1.94 $2.13 $2.38 $2.06 $3.13 $2.50 $2.06
Such market quotations reflect inter-dealer prices, without retail mark-
up, mark-down or commission. As of March 18, 1998, the Company had 8,000,000
($.10 per share par value) common shares authorized and 2,420,884 common shares
outstanding, and there were approximately 1,750 shareholders of record. The
last sales price of the Company's common stock on March 18, 1998 was $2.13 as
quoted on The Nasdaq Stock Market.
On December 31, 1997, the Company sold an aggregate of 80,820 shares of
common stock in a private placement transaction to seven individual "accredited
investors", as defined in Regulation D under the Securities Act of 1933, as
amended (the "Act"), at a purchase price of $2.32 per share, for an aggregate
consideration of $187,502. The sales were exempt from registration under the
Act pursuant to Rule 506 of Regulation D. The private placement transaction
was undertaken to ensure that the stockholders' equity of the Company as of
December 31, 1997 would be above the $2,000,000 minimum required by the Nasdaq
SmallCap Market for continued listing of the Company's common stock as of such
date. (See Item 13-Certain Relationships and Related Transactions.)
ITEM 6 - SELECTED FINANCIAL DATA
The selected financial data set forth below has been derived from the
audited financial statements of the Company. The information should be read in
conjunction with the audited financial statements and related notes appearing
elsewhere in this Form 10-K.
Year Ended December 31,
1997 1996 1995 1994 1993
Statement of Operations
Data:
Total Revenues $4,556,678 $4,440,188 $4,937,529 $4,438,747 $3,941,342
Product Sales 3,982,798 4,054,191 4,350,340 3,984,942 3,400,342
Research &
Development Expenses 1,068,069 1,291,043 1,578,145 1,366,294 879,181
Net Profit (Loss) 263,852 (66,202) 29,811 (148,266) (22,008)
Per Common Share:
Basic Net Profit (Loss) .11 (.03) .01 (.06) (.01)
Diluted Net Profit (Loss) .10 (.03) .01 (.06) (.01)
Stockholders' Equity .96 .81 .83 .82 .89
Cash Dividend -- -- -- -- --
Balance Sheet Data:
Total Assets 3,231,050 3,131,399 3,234,426 3,074,649 3,126,244
Cash, Cash
Equivalents and
Short term
Investments 1,021,324 1,044,441 1,550,011 1,295,246 1,459,510
Current Liabilities 561,795 684,163 720,767 569,377 444,034
Net Working Capital 1,642,363 1,405,099 1,849,580 1,727,525 2,160,300
Long-Term Debt
Obligations 339,747 570,022 608,343 629,767 349,868
Stockholders' Equity $2,329,508 $1,877,214 $1,905,316 $1,875,505 $2,332,342
ITEM 7 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Results of Operations
Fiscal 1997 Compared to Fiscal 1996
Total revenues for the year ended December 31, 1997 of $4,557,000
increased by $116,000 (3%) from $4,440,000 in 1996. Product sales for the year
ended December 31, 1997 of $3,983,000 were $71,000 (2%) less than the product
sales recorded in 1996. Product selling prices have generally increased in
line with inflation. Other revenues, comprised of technology licensing income,
grant income and collaborative research and development revenue increased to
$574,000 in 1997 from $386,000 in 1996.
Aggregate sales of the Kamar Heatmount{TM} Detector and
First Defense totaled approximately $3,770,000 (95% of total
product sales) for the year ended December 31, 1997 as compared to
approximately $3,642,000 (90% of total product sales) for the year ended
December 31, 1996. Sales of First Defense declined in 1996 due to a collapse
of calf prices from over $1.00 per pound in 1995 to less than $.60 per pound in
1996. The 1997 sales were back to within 96% of the sales level recorded in
1995. The sales of this product are seasonal with highest sales expected in
the winter months.
Sales of the Company's human infectious disease diagnostic reagents
decreased to approximately $58,000 (1% of total product sales) for the year
ended December 31, 1997 from approximately $227,000 (6% of total product sales)
for the year ended December 31, 1996.
The Company received technology licensing income totaling $325,000 (7% of
total revenues) in 1997, which was comprised of a $75,000 option payment
received in January 1997 and a $250,000 payment received in November 1997 upon
the exercise of the option for a license to the Company's milk protein
purification technology for use in the purification of certain milk proteins
other than lactoferrin. The Company received no similar technology licensing
income in 1996. Collaborative research and development revenue of $65,000 (1%
of total revenues) in 1996 was earned to support pilot plant development work
with the Company's joint venture partner to produce and sell lactoferrin. No
such collaborative research and development revenue was earned by the Company
in 1997.
Grant income decreased to approximately $249,000 (5% of total revenues)
in 1997 as compared to $321,000 in 1996. In October 1997, the Company was
awarded approximately $710,000 under a two-year federal research grant to
partially fund the Company's efforts to develop a product to prevent Travelers'
Diarrhea. Approximately $200,000 in grant income was recognized under this
grant in 1997. In 1994, the Company was awarded the aggregate amount of
approximately $932,000 under two federal research grants that partially funded
the Company's efforts to develop a product to prevent infection by
Cryptosporidium parvum. Work under these grants was completed in 1996.
Approximately $269,000 was recognized in 1996 under these two grants. Grant
income in 1996 also includes approximately half of a $100,000 federal research
grant obtained by the Company to partially fund the development of a commercial
prototype of the Company's diagnostic test to detect Cryptosporidium parvum in
water. The remaining $49,000 in income under this grant was recognized in
1997.
Interest expense exceeded interest income by approximately $31,000 in
1997. Interest expense exceeded interest income by $30,000 in 1996. Interest
expense was incurred in both years on the Company's outstanding bank debt.
Additional development costs and limited initial sales of joint venture
products resulted in a $13,000 loss from investment in joint venture in 1997.
Product costs amounted to 46% of product sales in 1997 as compared to 47%
in 1996. Internally developed products tend to have higher gross margin
percentages than licensed-in products, and the Company expects to achieve
incremental efficiencies in the manufacturing processes, as it continues to
implement process improvements.
The Company decreased its expenditures for research and development to
approximately $1,068,000 in 1997 as compared to $1,291,000 in 1996. Research
and development expenses exceeded collaborative research and development
revenue and grant income by approximately $819,000 in 1997 and by $905,000 in
1996. The 1997 spending on research and development aggregated 23% of total
revenues as compared to 29% in 1996.
The primary focus of the Company's research and development programs is
on the development of passive antibody products to prevent gastrointestinal
diseases. The Company has one product, TravelGAM{TM}, in clinical trials to
prevent diarrhea caused by certain E. coli (commonly known as Travelers'
Diarrhea) and a second product, DiffGAM{TM}, in clinical trials to prevent and
treat Clostridium Difficile-associated diarrhea. Results from a Phase II field
trial of TravelGAM completed in March 1998 were inconclusive requiring further
evaluation of this product (See Item 1-"Business"). The Company has also
invested in the development of a test intended to detect the presence of
Cryptosporidium parvum in drinking water. Additionally, the Company has
conducted significant development of a milk purification process that was
successfully licensed to a corporate partner in 1997 for use in the
purification of certain milk proteins other than lactoferrin.
Research and development expenses that are not supported by an outside
source of revenue limited the 1997 profit to $264,000. The Company believes
that a net operating loss may be incurred in 1998 and that this expected loss
can be funded internally. The Company believes that advancing its research and
development programs and incurring the resulting loss is necessary to create
value in its product portfolio by performing early stage validation of its
technology. However, for product development to proceed into more expensive
Phase III clinical trials, potential partners or new sources of capital would
be required to fund much of the continued clinical trial expenses.
Sales and marketing expenses increased by $107,000 (15%) to $817,000 (21%
of total product sales) in 1997 from $710,000 (18% of total product sales) in
1996. The Company continues to leverage its small sales force through wholesale
distribution channels. General and administrative expenses were approximately
$546,000 in 1997 as compared to $588,000 in 1996. The Company has continued
its efforts to control its general and administrative expenses while incurring
all the necessary expenses associated with being a publicly held company.
Fiscal 1996 Compared to Fiscal 1995
Total revenues for the year ended December 31, 1996 of $4,440,000
decreased by $498,000 (10%) from $4,938,000 in 1995. Product sales for the
year ended December 31, 1996 of $4,054,000 were $296,000 (7%) less than the
product sales recorded in 1995. While product selling prices have generally
increased in line with inflation, the decrease in sales volume is generally due
to a decline in the price of beef at the farm level which leads farmers to
spend less on animal health products.
Aggregate sales of the Kamar Heatmount{TM} Detector and
First Defense totaled approximately $3,642,000 (90% of total
product sales) for the year ended December 31, 1996 as compared to
approximately $3,661,000 (84% of total product sales) for the year ended
December 31, 1995. First Defense sales declined due to the collapse of calf
prices from over $1.00 per pound in 1995 to less than $.60 per pound in 1996.
Given these market conditions, farmers elected to reduce their expenditures on
a product like First Defense in 1996. The sales of this product are seasonal
with highest sales expected in the winter months.
Sales of the Company's human infectious disease diagnostic reagents
decreased to approximately $227,000 (6% of total product sales) for the year
ended December 31, 1996 from approximately $553,000 (13% of total product sales)
for the year ended December 31, 1995.
Collaborative research and development revenue increased to approximately
$65,000 (1% of total revenues) in 1996 as compared to $10,000 (less than 1% of
total revenues) in 1995. This $75,000 in revenue was earned to support pilot
plant development work with the Company's joint venture partner to produce and
sell lactoferrin.
Grant income decreased to approximately $321,000 (7% of total revenues)
in 1996 as compared to $577,000 in 1995. In 1994, the Company was awarded the
aggregate amount of approximately $932,000 under two federal research grants
that partially funded the Company's efforts to develop a product to prevent
infection by Cryptosporidium parvum. Work under these grants was completed in
1996. Approximately $269,000 and $465,000 was recognized in 1996 and 1995,
respectively, under these two grants. Grant income in 1996 also includes
approximately half of a $100,000 federal research grant obtained by the Company
to partially fund the development of a commercial prototype of the Company's
diagnostic test to detect Cryptosporidium parvum in water. Grant income in
1995 included $99,000 from a federal research grant supporting the Company's
effort to develop a milk antibody product to prevent Travelers' Diarrhea and
$13,000 received under a state research grant.
Interest expense exceeded interest income by approximately $30,000 in
1996. Interest and other income exceeded interest expense by $33,000 in 1995.
Interest expense was incurred in both years on the Company's outstanding bank
debt. Other income in 1995 included rental income from a lease to a tenant
that expired in October 1995.
Product costs amounted to 47% of product sales in 1996 as compared to 45%
in 1995. Internally developed products tend to have higher gross margin
percentages than licensed-in products, and the Company expects to achieve
incremental efficiencies in the manufacturing processes, as it continues to
implement process improvements. The gross margin on human infectious disease
diagnostic reagents is better than the gross margin on the Company's animal
health products.
The Company decreased its expenditures for research and development to
approximately $1,291,000 in 1996 as compared to $1,578,000 in 1995. Research
and development expenses exceeded collaborative research and development
revenue and grant income by approximately $905,000 in 1996 and by $991,000 in
1995. The 1996 spending on research and development aggregated 29% of total
revenues as compared to 32% in 1995.
The primary focus of the Company's research and development programs is
on the development of passive antibody products to prevent gastrointestinal
diseases. The Company has one product, CryptoGAM{TM}, in clinical trials to
prevent and/or treat cryptosporidiosis in AIDS patients and a second product,
TravelGAM{TM}, in clinical trials to prevent diarrhea caused by certain E. Coli
(commonly known as Travelers' Diarrhea). The Company filed an Investigational
New Drug ("IND") application in early 1997 for a third product, DiffGAM{TM}, to
prevent and treat Clostridium difficile-associated diarrhea. The Company has
also invested in the development of a test intended to detect the presence of
Cryptosporidium parvum in drinking water. Additionally, the Company has
conducted significant development of a milk purification process that may have
commercial utility for certain food ingredient applications.
Research and development expenses that are not supported by an outside
source of revenue are the primary cause of the Company's loss in 1996. The
Company believes that advancing its research and development programs and
incurring the resulting expenses is necessary to create value in its product
portfolio by performing early stage validation of its technology. However, for
product development to proceed into more expensive Phase III clinical trials,
potential partners or new sources of capital would be required to fund much of
the continued clinical trial expenses.
Sales and marketing expenses decreased by $96,000 (a 12% decrease) to
$710,000 (18% of total product sales) in 1996 from $806,000 (19% of total
product sales) in 1995. The Company continues to leverage its small sales force
through wholesale distribution channels. General and administrative expenses
were approximately $588,000 in 1996 as compared to $600,000 in 1995. The
Company has continued its efforts to control its general and administrative
expenses while incurring all the necessary expenses associated with being a
publicly held company.
Financial Position, Liquidity and Capital Resources
The Company's total assets increased to $3,231,000 at December 31, 1997
from $3,131,000 at December 31, 1996. The Company's cash balance as of
December 31, 1997 decreased to $1,021,000 from $1,044,000 at December 31, 1996.
Net working capital increased to $1,642,000 at December 31, 1997 from
$1,405,000 at December 31, 1996. Stockholders' equity increased to $2,330,000
at December 31, 1997 from $1,877,000 at December 31, 1996.
During 1997, approximately $99,000 in cash was provided by operating
activities as the cash generated by the net profit and a reduction in inventory
was, in part, offset by an increase in accounts receivable and a reduction in
payables. Approximately $84,000 in cash was invested in production equipment
and one of the Company's joint ventures during the year. Cash used to repay
bank debt exceeded cash raised through the issuance of common stock by $38,000
in 1997.
As is the case with most early stage biotechnology companies, the Company
funds a large portion of its research and development expenses through
strategic alliances with corporate partners, federal research grants and equity
financing with the prospect of becoming profitable if products can be
successfully commercialized. The size of the Company's research and
development programs and the speed at which these programs are funded is, in
large part, determined by the level of financing completed. However, during
the year ended December 31, 1997, the gross margin from product sales was
sufficient to contribute $800,000 to the research and development programs
after covering all general, sales and administrative expenses. This $800,000
contribution compares to a $869,000 contribution in 1996, a $988,000
contribution in 1995, a $737,000 contribution in 1994, a $287,000 contribution
in 1993 and a $190,000 deficit in 1992. The contribution from the operating
(non-research and development) side of the Company's business allows the
Company to be less dependent on raising capital in the equity markets to fund
its ongoing operations.
Since 1990, the Company has been awarded five Phase I and three Phase II
Small Business Innovation Research grants from the National Institutes of
Health. These grants aggregate approximately $1,991,000 in funding for the
Company's research and development programs. Approximately $1,232,000 of this
grant income was recognized prior to 1997, approximately $249,000 was
recognized in 1997 and an aggregate amount of approximately $510,000 is
expected to be recognized in 1998 and 1999. Approximately $268,000 of this
$510,000 in available funding is expected to support internal research and
development expenses, and the remaining $242,000 is budgeted to fund
development work done by outside laboratories. The Company continues to seek
federal research grant support as a means of leveraging the funds that it is
able to spend developing new products.
On December 31, 1997, the Company sold an aggregate of 80,820 shares of
common stock in a private placement transaction for an aggregate consideration
of $187,502. The private placement transaction was undertaken to ensure that
the stockholders' equity of the Company as of December 31, 1997 would be above
the $2,000,000 minimum required by the Nasdaq SmallCap Market for continued
listing of the Company's common stock as of such date. (See Item 13-Certain
Relationships and Related Transactions.)
Long-term debt decreased from $570,000 at December 31, 1996 to $340,000 at
December 31, 1997. The current portion of these mortgage and bank note debt
obligations remained essentially unchanged at approximately $230,000 at
December 31, 1997 and December 31, 1996. The Company is obligated to make
monthly principal and interest payments aggregating $25,000 under these debt
obligations. (See Note 5 to the accompanying financial statements for further
detail on these debt obligations).
Management believes that its current cash and investments balance will be
sufficient to meet its operating and capital requirements in 1998. Management
intends to keep expenditure levels in the appropriate relation to the amount of
equity raised, expected revenues and the resulting amount of available cash.
Forward-Looking Statements
The statements contained in this report which are not historical fact are
"forward-looking statements" that involve various important assumptions,
risks, uncertainties and other factors. There can be no assurance that actual
results will not differ materially from those projected or suggested in such
forward-looking statements as a result of various factors including, but not
limited to, the risk factors discussed below. The Company is heavily dependent
on the successful development of new products for its future growth. These
new products have the potential to increase the Company's profitability.
The Company has entered into two joint ventures that began initial and
limited commercial sales of new products in 1997. First, the manufacturing
facility constructed by AgriCell for the production of lactoferrin is capable
of producing product valued at up to $2,000,000 annually at full capacity.
(See Item 1 - Business, "Two Joint Ventures"). Secondly, the Company estimates
that sales by Clearwater Diagnostics Company, LLC of Crypto-Scan{TM } water
diagnostic test could reach several millions of dollars per year if market
acceptance can be achieved and maintained. (See Item 1 - Business, "Two Joint
Ventures"). The ultimate profitability of these joint ventures cannot be
accurately predicted at this time.
If clinical trials are successful, sales of TravelGAM{TM} and DiffGAM{TM}
would not be anticipated to begin until approximately the year 2000, due to
the complex regulatory process required to obtain approval of these products.
If the products are successfully developed, the Company intends to enter into
marketing alliances with corporate partners to distribute these products. The
Company estimates that any such partner could achieve potential sales of
TravelGAM in the range of $75,000,000 to $125,000,000, and potential sales of
DiffGAM could be approximately twice that amount. The Company anticipates
being able to financially benefit from manufacturing and supply agreements, or
other royalty arrangements with potential marketing partners. The ultimate
profitability of these products cannot be accurately predicted at this time.
By reducing research and development expenses, the Company presently has
the ability to report increasing net profits. However, the Company has elected
to aggressively fund its research and development programs with the objective
of benefiting from the growth that successful new products may create. The
Company intends to fund several important clinical trials in 1998 that may
create a net operating loss. At the same time, the Company is seeking
licensing payments for rights to the Company's new products under development
that, if successfully negotiated, may be sufficient to result in a net
operating profit in 1998.
Going forward into 1998, it is the Company's objective to enter into an
alliance(s) with a marketing partner(s) to fund much of the Company's research
and development expenditures. It is the Company's objective to fund all
selling, general and administrative expenses as well as all research and
development expenditures that are not funded by an outside source with the
gross margin earned from current product sales and from available cash. If the
research and development funding objectives are achieved, the increasing
profitability of the Company during 1998 would principally be determined by the
market acceptance of Crypto-Scan{TM}, lactoferrin and whey protein isolate.
Further growth in profitability would be principally contingent on successfully
entering into marketing alliances with corporate partners and obtaining FDA
approval to sell the Company's milk antibody products for humans.
Risk Factors
The development of these new products is subject to financial, efficacy,
regulatory and market risks. There can be no assurance that the Company will
be able to finance the development of these new product opportunities nor that,
if financed, the new products will be found to be efficacious and gain the
appropriate regulatory approval. Furthermore, if regulatory approval is
obtained, there can be no assurance that the market estimates will prove to be
accurate or that market acceptance at a profitable price level can be achieved
or that the products can be profitably manufactured.
Effects of Inflation and Interest Rates
The Company believes that neither inflation nor interest rates have had a
significant effect on revenues and expenses.
ITEM 8 - FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements of the Company, together with the notes thereto
and the report of the accountants thereon, are set forth on Pages F-1 through
F-13 at the end of this report.
ITEM 9 - CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None
PART III
ITEM 10 - DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
(A) Information with respect to the Company's directors is incorporated
herein by reference to the section of the Company's 1998 Proxy Statement titled
"Election of the Board of Directors", which is intended to be filed with the
Securities and Exchange Commission within 120 days after the end of the
Company's fiscal year.
(B) The Company's executive officers are as follows:
MICHAEL F. BRIGHAM (Age: 37, Officer Since: October 1991) was elected Chief
Financial Officer and Treasurer of the Company in October 1991 and was
appointed Secretary in December 1995. Prior to that, he served as Director of
Finance and Administration for the Company since September 1989. Mr. Brigham
serves on the Board of Directors of the Biotechnology Association of Maine and
of the Maine Center for Innovation in Biotechnology. 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.
JOSEPH H. CRABB, PH.D. (Age: 43, Officer Since: March 1996) was elected Vice
President of Research and Development of the Company in March 1996. Prior to
that, he served as Director of Research and Development for the Company. Dr.
Crabb currently holds a Clinical Assistant Professorship at Tufts University
School of Veterinary Medicine and serves on the American Water Works
Association's Research Foundation project advisory committees 351 and 492.
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.
THOMAS C. HATCH (Age: 44, Officer Since: October 1991, Director Since: August
1992) was elected President and Chief Executive Officer of the Company in
October 1991 and is a member of the Executive Committee of the Company's Board
of Directors. Prior to that, he served as Manager of Commercial Development
for the Company since May 1989. Prior to joining the Company, he held various
product management and sales positions in the Animal Health and Crop Protection
Chemical businesses of the American Cyanamid Company. Prior to that, he had
been an Economic Analyst with the U.S. Department of Agriculture in Washington.
Mr. Hatch earned his Masters in Business Administration from the University of
Virginia in 1984.
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 executive officers of the
Company is incorporated herein by reference to the section of the Company's
1998 Proxy Statement titled "Executive Compensation", which is intended to be
filed with the Securities and Exchange Commission within 120 days after the end
of the Company's fiscal year.
ITEM 12 - SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Information regarding ownership of the Company's common stock by certain
owners and management is incorporated herein by reference to the section of the
Company's 1998 Proxy Statement titled "Security Ownership of Certain Beneficial
Owners and Management", which is intended to be filed with the Securities and
Exchange Commission within 120 days after the end of the Company's fiscal year.
ITEM 13 - CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Information regarding certain transactions with management and others is
incorporated herein by reference to the section of the Company's 1998 Proxy
Statement titled "Certain Relationships and Related Transactions", which is
intended to be filed with the Securities and Exchange Commission within 120
days after the end of the Company's fiscal year.
PART IV
ITEM 14 - EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(a) Exhibits
3.1 Certificate of Incorporation of the Registrant (incorporated by reference
to Exhibit 3.1 of the Registrant's 1987 Registration Statement Number 33-
12722 on Form S-1 as filed with the Commission).
3.2 Certificate of Amendment to the Company's Certificate of Incorporation
(incorporated by reference to Exhibit 4.1 to the Registrant's Quarterly
Report on Form 10-Q for the three months ended June 30, 1990).
3.3 Certificate of Amendment to the Company's Certificate of Incorporation
effective August 24, 1992 (incorporated by reference to Exhibit 3.4 of
the Registrant's Annual Report on Form 10-K for the fiscal year ended
December 31, 1992).
3.4 Bylaws of the Registrant as amended (incorporated by reference to Exhibit
3.3 to the Registrant's Annual Report on Form 10-K for the fiscal year
ended December 31, 1995).
4.1 Specimen of the Company's Common Stock Certificate (incorporated by
reference to Exhibit 4.1 to the Registrant's Quarterly Report on Form 10-
Q for the three months ended September 30, 1990).
4.2 $220,000 Note payable to Peoples Heritage Bank dated November 3, 1993
(incorporated by reference to Exhibit 4.1 to the Registrant's Current
Report on Form 8-K dated November 4, 1993).
4.3 $500,000 Commercial Note to Peoples Heritage Bank dated October 7, 1994
(incorporated by reference to Exhibit 4.1 to the Registrant's Quarterly
Report on Form 10-Q for the three months ended September 30, 1994).
4.4 $200,000 Commercial Note payable to Peoples Heritage Bank dated September
28, 1995 (incorporated by reference to Exhibit 4.1 to the Registrant's
Quarterly Report on Form 10-Q for the three months ended September 30,
1995).
4.5 Rights Agreement dated as of September 5, 1995, between the Registrant
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 Registrant's Current
Report on Form 8-K dated September 5, 1995).
4.6 $200,000 Commercial Note Payable to Peoples Heritage Bank dated September
13, 1996 (incorporated by reference to Exhibit 4.1 to the Registrant's
Quarterly Report on Form 10-Q for the three months ended September 30,
1996).
10.1{+}1989 Stock Option and Incentive Plan of the Registrant (incorporated by
reference to Exhibit 10.27 to the Registrant's Annual Report on Form 10-K
for the fiscal year ended December 31, 1989).
10.2{+}Form of Incentive Stock Option Agreement (incorporated by reference to
Exhibit 10.28 to the Registrant's Annual Report on Form 10-K for the
fiscal year ended December 31, 1989).
10.3{+}Form of Indemnification Agreement entered into with each of the
Company's directors and officers (incorporated by reference to
Exhibit 10.32 to the Registrant's Annual Report on Form 10-K for the
fiscal year ended December 31, 1989).
10.4{+}Employment Agreement dated November 1991 between the Registrant and
Michael F. Brigham (incorporated by reference to Exhibit 10.37 to the
Registrant's Annual Report on Form 10-K for the fiscal year ended
December 31, 1991).
10.5{+}Employment Agreement dated November 1991 between the Registrant and
Thomas C. Hatch (incorporated by reference to Exhibit 10.38 to
the Registrant's Annual Report on Form 10-K for the fiscal year ended
December 31, 1991).
10.6{+}Amendment, dated April 1992, to Employment Agreement dated November
1991, between the Registrant and Michael F. Brigham (incorporated by
reference to Exhibit 10.26 to the Registrant's Annual Report on Form 10-K
for the fiscal year ended December 31, 1992).
10.7{+}Amendment, dated April 1992, to Employment Agreement dated November
1991, between the Registrant and Thomas C. Hatch (incorporated by
reference to Exhibit 10.29 to the Registrant's Annual Report on Form 10-
K for the fiscal year ended December 31, 1992).
10.8 License and Supply Agreement between Bio-Vac, Inc. and the Registrant
dated June 15, 1993 (incorporated by reference to Exhibit 10.25 to the
Registrant's Annual Report on Form 10-K for the fiscal year ended
December 31, 1993).
10.9* ImmuCell - Advanced Separation Technologies, Inc. Agreement for
exclusivity in protein separation of milk or whey proteins, dated August
30, 1993 (incorporated by reference to Exhibit 10.27 to the Registrant's
Annual Report on Form 10-K for the fiscal year ended December 31, 1993).
10.10 Distribution and Licensing Agreement between Kamar, Inc. and the
Registrant dated December 3, 1993 (incorporated by reference to Exhibit
10.30 to the Registrant's Annual Report on Form 10-K for the fiscal year
ended December 31, 1993).
10.11 Amendment No. 1 to Agreement for Exclusivity between Advanced Separation
Technologies, Inc. and the Registrant dated January 14, 1994
(incorporated by reference to Exhibit 10.33 to the Registrant's Annual
Report on Form 10-K for the fiscal year ended December 31, 1993).
10.12** Exclusive License Agreement between The Regents of the University of
California of Alameda, California and the Registrant dated February 23,
1994 (incorporated by reference to Exhibit 10.1 to the Registrant's
Quarterly Report on Form 10-Q for the three months ended March 31, 1994).
10.13 Non-qualified Stock Option Agreement dated November 10, 1994 between the
Registrant and Redwood MicroCap Fund, Inc (incorporated by reference to
Exhibit 10.25 to the Registrant's Annual Report on Form 10-K for the
fiscal year ended December 31, 1994).
10.14 Amendment No. 2 to Agreement for Exclusivity between Advanced Separation
Technologies, Inc. and the Registrant dated December 16, 1994
(incorporated by reference to Exhibit 10.26 to the Registrant's Annual
Report on Form 10-K for the fiscal year ended December 31, 1994).
10.15***License Agreement between Registrant and Wisconsin Alumni Research
Foundation effective March 1, 1995 (incorporated by reference to Exhibit
10.1 to the Registrant's Quarterly Report on Form 10-Q for the three
months ended March 31, 1995).
10.16 1995 Stock Option Plan for Outside Directors (incorporated by reference
to Exhibit 10.1 to the Registrant's Quarterly Report on Form 10-Q for the
three months ended June 30, 1995).
10.17 Form of Stock Option Agreement (incorporated by reference to Exhibit 10.2
to the Registrant's Quarterly Report on Form 10-Q for the three months
ended June 30, 1995).
10.18 Amendment No. 3 to Agreement for Exclusivity between Advanced Separation
Technologies, Inc. and the Registrant dated May 3, 1995 (incorporated by
reference to Exhibit 10.5 to the Registrant's Quarterly Report on Form
10-Q for the three months ended June 30, 1995).
10.19 Amendment No. 4 to Agreement for Exclusivity between Advanced Separation
Technologies, Inc. and the Registrant dated November 15, 1995
(incorporated by reference to Exhibit 10.28 to the Registrant's Annual
Report on Form 10-K for the fiscal year ended December 31, 1995).
10.20{+}Employment Agreement dated November 1991 between the Registrant and
Joseph H Crabb (incorporated by reference to Exhibit 10.30 to the
Registrant's Annual Report on Form 10-K for the fiscal year ended
December 31, 1995).
10.21{+} Amendment, dated March 1992, to Employment Agreement dated November
1991, between the Registrant and Joseph H. Crabb (incorporated by
reference to Exhibit 10.31 to the Registrant's Annual Report on Form 10-K
for the fiscal year ended December 31, 1995).
10.22{+}Amendment, dated April 1992, to Employment Agreement dated November
1991, between the Registrant and Joseph H. Crabb (incorporated by
reference to Exhibit 10.32 to the Registrant's Annual Report on Form 10-
K for the fiscal year ended December 31, 1995).
10.23 Limited Liability Company Agreement of AgriCell Company, LLC dated as of
September 10, 1996 between the Registrant and Agri-Mark, Inc. of Methuen,
MA (incorporated by reference to Exhibit 10.1 to the Registrant's
Quarterly Report on Form 10-Q for the three months ended September 30,
1996).
10.24 Limited Liability Company Agreement of Clearwater Diagnostics Company,
LLC dated as of September 17, 1996 between the Registrant and Membrex,
Inc. of Fairfield, NJ (incorporated by reference to Exhibit 10.2 to the
Registrant's Quarterly Report on Form 10-Q for the three months ended
September 30, 1996).
10.25 Amendment No. 5 to Agreement for Exclusivity between Advanced
Separation Technologies, Inc. and the Registrant dated October 2,
1997.
10.26****License Agreement between the Registrant and Murray Goulburn Co-
operative Co., Limited dated November 14, 1997.
21.1 Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1
to the Registrant's Annual Report on Form 10-K for the fiscal year ended
December 31, 1996).
23.1 Consent of Coopers & Lybrand L.L.P.
27.1 Financial Data Schedule (Filed Only Electronically).
*Confidential Treatment as to certain portions obtained effective until
December 31, 2000. The copy filed as an exhibit omits the information subject
to the Confidential Treatment.
**Confidential Treatment as to certain portions obtained effective until
March 31, 1999. The copy filed as an exhibit omits the information subject to
the Confidential Treatment.
***Confidential Treatment as to certain portions has been requested
effective until March 1, 2005. The copy filed as an exhibit omits the
information subject to the confidentiality request.
****Confidential Treatment as to certain portions has been requested
effective until November 14, 2012. The copy filed as an exhibit omits the
information subject to the confidentiality request.
+ Management contract or compensatory plan or arrangement.
(b) Index to Financial Statement Schedules
Report of Coopers & Lybrand L.L.P., Independent Accountants F-1
Consolidated Balance Sheets - December 31, 1997 and 1996 F-2 to F-3
Consolidated Statements of Operations for the years ended
December 31, 1997, 1996 and 1995 F-4
Consolidated Statements of Stockholders' Equity for the years
ended December 31, 1997, 1996, and 1995 F-5
Consolidated Statements of Cash Flows for the years ended
December 31, 1997, 1996 and 1995 F-6
Notes to Consolidated Financial Statements F-7 to F-13
All financial statement schedules have been omitted as they are not required,
are not applicable, or the information is included in the consolidated
financial statements or otherwise.
(c) Reports on 8-K
None
REPORT OF INDEPENDENT ACCOUNTANTS
Board of Directors
ImmuCell Corporation
We have audited the accompanying consolidated balance sheets of ImmuCell
Corporation and Subsidiary as of December 31, 1997 and 1996, and the
related consolidated statements of operations, stockholders' equity, and
cash flows for each of the three years in the period ended December 31,
1997. 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 generally accepted auditing
standards. Those standards require that we plan and perform the audits to
obtain reasonable assurance about whether the financial statements are free
of material misstatement. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial
statements. An audit also includes 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 consolidated financial statements referred to above
present fairly, in all material respects, the consolidated financial
position of ImmuCell Corporation and Subsidiary as of December 31, 1997 and
1996 and the consolidated results of their operations and their cash flows
for each of the three years in the period ended December 31, 1997 in
conformity with generally accepted accounting principles.
/s/ Coopers & Lybrand L.L.P.
Portland, Maine
January 30, 1998
IMMUCELL CORPORATION AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
DECEMBER 31, 1997 AND 1996
ASSETS
1997 1996
-----------------------------------
CURRENT ASSETS:
Cash and cash equivalents $1,021,324 $1,044,441
Accounts receivable, net of allowance
for doubtful accounts of $43,000 and
$49,000 at December 31, 1997 and 1996,
respectively (See Note 2(c)) 681,267 370,798
Inventories 474,526 648,276
Prepaid expenses and accrued interest 27,041 25,747
-----------------------------------
Total current assets 2,204,158 2,089,262
EQUIPMENT, BUILDING AND
IMPROVEMENTS, at cost:
Laboratory and manufacturing equipment 807,969 754,891
Building and improvements 580,822 580,747
Office furniture and equipment 60,953 54,977
Land 50,000 50,000
-----------------------------------
1,499,744 1,440,615
Less-accumulated depreciation 710,361 623,987
-----------------------------------
Net equipment, building and
improvements 789,383 816,628
INVESTMENTS IN JOINT VENTURES 236,669 224,669
OTHER ASSETS 840 840
-----------------------------------
TOTAL ASSETS $3,231,050 $3,131,399
===================================
The accompanying notes are an integral part of the financial statements.
IMMUCELL CORPORATION AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
DECEMBER 31, 1997 AND 1996
LIABILITIES AND STOCKHOLDERS' EQUITY
1997 1996
-----------------------------------
CURRENT LIABILITIES:
Accounts payable $ 157,223 $ 269,585
Accrued expenses 174,298 185,256
Current portion of long term debt 230,274 229,322
----------------------------------
Total current liabilities 561,795 684,163
LONG-TERM DEBT:
Notes payable 142,191 367,165
Mortgage loan 197,556 202,857
----------------------------------
Total long-term debt 339,747 570,022
COMMITMENTS AND CONTINGENT LIABILITIES
STOCKHOLDERS' EQUITY:
Common stock, Par value - $.10 per share
Authorized-8,000,000
Issued-2,804,482 and 2,719,162
shares at December 31, 1997 and
1996, respectively 280,448 271,916
Capital in excess of par value 8,319,701 8,139,791
Accumulated deficit (5,683,906) (5,947,758)
----------------------------------
2,916,243 2,463,949
Treasury stock,at cost-389,598 shares (586,735) (586,735)
----------------------------------
Total stockholders' equity 2,329,508 1,877,214
----------------------------------
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY $3,231,050 $3,131,399
==================================
The accompanying notes are an integral part of the financial statements.
IMMUCELL CORPORATION AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE YEARS ENDED DECEMBER 31,
1997 1996 1995
-------------------------------------------
REVENUES:
Product sales $3,982,798 $4,054,191 $4,350,340
Technology licensing income 325,000 -- --
Grant income 248,880 320,997 577,189
Collaborative research
and development revenue -- 65,000 10,000
--------------------------------------------
Total revenues 4,556,678 4,440,188 4,937,529
COSTS AND EXPENSES:
Product costs 1,819,587 1,886,745 1,957,095
Research and development
expenses 1,068,069 1,291,043 1,578,145
Sales and marketing
expenses 817,089 710,045 805,875
General and administrative
expenses 546,073 588,446 599,696
--------------------------------------------
Total costs and expenses 4,250,818 4,476,279 4,940,811
Interest and other income 39,802 44,899 105,624
Interest expense (68,378) (75,010) (72,531)
Equity in loss on investment
in joint venture (13,432) -- --
--------------------------------------------
Net interest and other (42,008) (30,111) 33,093
--------------------------------------------
NET PROFIT (LOSS) $ 263,852 $ (66,202) $ 29,811
============================================
BASIC NET PROFIT (LOSS)
PER COMMON SHARE $ .11 $ (.03) $ .01
DILUTED NET PROFIT (LOSS)
PER COMMON SHARE $ .10 $ (.03) $ .01
============================================
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING 2,332,939 2,318,244 2,291,981
============================================
The accompanying notes are an integral part of the financial statements.
IMMUCELL CORPORATION AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
FOR THE YEARS ENDED DECEMBER 31, 1997, 1996 AND 1995
Common Stock Capital
$.10 Par in Treasury Total
Value Excess Accumu- Stock Stock-
--------------- of lated -------------- holders'
Shares Amount Par Value Deficit Shares Amount Equity
------ ------ --------- ------- ------ ------ ------
BALANCE,
December
31, 1994 2,681,579 $268,159 $8,105,448 $(5,911,367) 389,598 $(586,735) $1,875,505
Net profit -- -- -- 29,811 -- -- 29,811
----------------------------------------------------------------------
BALANCE,
December
31, 1995 2,681,579 268,159 8,105,448 (5,881,556) 389,598 (586,735) 1,905,316
Net loss -- -- -- (66,202) -- -- (66,202)
Exercise
of stock
options 37,583 3,757 34,343 -- -- -- 38,100
----------------------------------------------------------------------
BALANCE,
December
31, 1996 2,719,162 271,916 8,139,791 (5,947,758) 389,598 (586,735) 1,877,214
Net Profit -- -- -- 263,852 -- -- 263,852
Issuance
of Common
Stock 80,820 8,082 174,517 -- -- -- 182,599
Exercise
of stock
options 4,500 450 5,393 -- -- -- 5,843
----------------------------------------------------------------------
BALANCE,
December
31, 1997 2,804,482 $280,448 $8,319,701 $(5,683,906) 389,598 $(586,735) $2,329,508
======================================================================
The accompanying notes are an integral part of the financial statements.
IMMUCELL CORPORATION AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31,
1997 1996 1995
-------------------------------------------
CASH FLOWS FROM
OPERATING ACTIVITIES:
Net profit (loss) $ 263,852 $ (66,202) $ 29,811
Adjustments to reconcile net
profit (loss) to net cash
provided by (used for)
operating activities-
Depreciation 98,872 113,027 182,834
Changes in:
Accounts receivable (310,469) (13,265) 43,646
Inventories 173,750 (12,073) (70,672)
Prepaid expenses and
accrued interest (1,294) 853 8,346
Accounts payable (112,362) 33,114 77,605
Accrued expenses (13,458) (130,156) 26,447
-------------------------------------------
Net cash provided by (used for)
operating activites 98,891 (74,702) 298,017
-------------------------------------------
CASH FLOWS FROM INVESTING
ACTIVITIES:
Purchase of equipment, building
and improvements, net (71,627) (362,395) (77,318)
Investment in joint ventures (12,000) (130,000) --
Decrease in other assets -- 1,310 8,152
-------------------------------------------
Net cash used for investing
activities (83,627) (491,085) (69,166)
-------------------------------------------
CASH FLOWS FROM FINANCING
ACTIVITIES:
Proceeds from debt obligations -- 200,000 200,000
Payments of debt obligations (229,323) (177,883) (166,068)
Proceeds from issuance of
common stock 193,345 38,100 --
Stock issuance costs (2,403) -- (8,018)
-------------------------------------------
Net cash (used for) provided by
financing activities (38,381) 60,217 25,914
-------------------------------------------
NET (DECREASE) INCREASE IN CASH
AND CASH EQUIVALENTS (23,117) (505,570) 254,765
BEGINNING CASH AND CASH
EQUIVALENTS 1,044,441 1,550,011 1,295,246
-------------------------------------------
ENDING CASH AND CASH
EQUIVALENTS $1,021,324 $1,044,441 $1,550,011
===========================================
CASH PAID FOR INTEREST $ 69,165 $ 75,398 $ 73,945
NON-CASH INVESTING ACTIVITIES:
TRANSFER OF NET FIXED ASSETS
TO JOINT VENTURE -- $ 94,669 --
===========================================
The accompanying notes are an integral part of the financial statements.
IMMUCELL CORPORATION AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(1) BUSINESS OPERATIONS
ImmuCell Corporation (the "Company") is a biotechnology company that
primarily develops, manufactures and markets milk-derived passive antibody
products to prevent and/or treat gastrointestinal infections in both humans and
animals. The Company was originally incorporated in Maine in 1982 and
reincorporated in Delaware in March 1987. In May 1987, the Company had an
initial public offering of its common stock and became a reporting company
under the Securities Exchange Act of 1934.
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 marketing of existing products and the
development of additional commercially viable products.
(2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(a) Consolidation Principles
The consolidated financial statements of the Company include the accounts
of the Company and its wholly-owned subsidiary, the Kamar Marketing Group, Inc.
All intercompany accounts and transactions have been eliminated in
consolidation. Certain amounts in the 1995 financial statements have been
reclassified to conform with the 1997 and 1996 financial statement
presentation.
(b) Cash and Cash Equivalents
The Company considers all highly liquid investment instruments purchased
with an original maturity of three months or less to be cash equivalents.
(c) Accounts Receivable
The accounts receivable balance at December 31, 1997 included $200,000
due from the federal government for the reimbursement of research grant
expenses. No such amount was recorded as of December 31, 1996.
(d) Inventories
Inventories include 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.
Inventories consist of the following:
DECEMBER 31,
1997 1996
-----------------------------------
Raw materials $ 17,583 $ 55,682
Work-in-process 376,673 548,083
Finished goods 80,270 44,511
-----------------------------------
$474,526 $648,276
===================================
(e) Equipment, Building and Improvements
The Company provides for depreciation and amortization on the straight-
line method by charges to operations in amounts estimated to allocate the cost
of the assets over their estimated useful lives, generally equal to five to ten
years for equipment and ten years for building improvements. The cost of the
building is being depreciated over 30 years.
(f) Revenue Recognition
Revenues related to the sale of manufactured products are recorded at
the time of shipment to the customer. Collaborative research and development
revenue and income on government research grants are recognized as
reimburseable expenses are incurred. Indirect costs which are billed to the
government are subject to their review. All related research and development
costs are expensed as incurred, as are all patent costs. Income from the sale
of technology licenses is recognized when definitive agreement as to terms is
reached, which approximates the receipt of the associated cash payments.
(g) Net Profits (Loss) Per Common Share
The basic net profits (loss) per common share have been computed in
accordance with Financial Accounting Standards Board Statement No. 128 by
dividing the net profits (loss) by the weighted average number of common shares
outstanding during the year. The denominator in the diluted net profit per
common share calculation in 1997 was increased by 466,167 "in-the-money" common
stock options and reduced by 269,013 shares that could have been repurchased
with the proceeds from the exercise of these common stock options. Options to
purchase 54,000 shares of common stock at prices ranging from $3.06 to $4.00
per share were outstanding during 1997 but not included in the computation of
diluted net profit per share because the options' exercise prices were greater
than the average market price of the common shares and, therefore, the effect
would be antidilutive. Common stock equivalents outstanding have not been
included in the 1996 diluted net loss per common share computation, as the
effect would be antidilutive, thereby decreasing the net loss per common share.
The denominator in the diluted net profit per common share calculation in 1995
was increased by 162,500 "in-the-money" common stock options and reduced by
121,785 shares that could have been repurchased with the proceeds from the
exercise of these common stock options. The prior period net profit (loss) per
share have been restated to conform to the provisions of this Statement. For
additional disclosures regarding the outstanding common stock options see Notes
7(a) and 7(b).
(h) 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.
(3) INVESTMENT IN JOINT VENTURES
In the third quarter of 1996, the Company made investments in two joint
ventures, AgriCell Company, LLC, ("AgriCell") and Clearwater Diagnostics
Company, LLC, ("CDC"), both Delaware limited liability companies. These
investments are accounted for under the equity method. The operating activity
of these joint ventures for the period from inception to December 31, 1997 was
not material.
First, the Company and Agri-Mark, Inc. of Methuen, Massachusetts formed
AgriCell to manufacture and sell lactoferrin, a nutritional milk protein
derived from cheese whey. The Company licensed certain proprietary technology
to AgriCell, invested $125,000 in new fixed assets and contributed other fixed
assets with a net book value of approximately $95,000 as well as additional
personnel costs to assist in the installation of the commercial production
facility. Agri-Mark invested approximately $1,000,000 in principally working
capital, fixed assets and production facility modifications. Agri-Mark has the
right to receive 90% of the profits from the joint venture until it obtains the
return of an amount equal to its original investment, after which all profits
are to be split equally.
Second, the Company and Membrex, Inc., of Fairfield, New Jersey, formed
CDC to manufacture and sell Crypto-Scan{TM }water diagnostic test. This test
is designed to monitor water supplies for the presence of Cryptosporidium, a
dangerous parasite for which there is no effective method of detection. The
Company invested $5,000 in cash and licensed certain proprietary technology to
the joint venture in 1996 and then invested another $12,000 in 1997. The
Company has the right to initially share equally with Membrex in all profits
from the sale of the test for use in monitoring drinking water. Membrex is
entitled to 55% of the profits beginning in the third year of commercial sales.
(4) ACCRUED EXPENSES
Accrued expenses consisted of the following:
DECEMBER 31,
1997 1996
-----------------------------------
Accrued royalties $ 53,866 $ 59,349
Accrued professional fees 35,656 32,682
Accrued payroll 46,204 30,332
Accrued other 38,572 62,893
-----------------------------------
$174,298 $185,256
===================================
(5) DEBT OBLIGATIONS
The Company has long-term debt obligations, net of current maturities, as
follows:
DECEMBER 31,
1997 1996
---------------------------
9.5% Bank mortgage, collateralized by
first security interest in building, due
1997 to 2000 $202,856 $207,728
10.0% Note payable to bank, collateralized
by accounts receivable, inventory and
certain fixed assets, due 1997 to 2000 146,180 189,701
10.27% Note payable to bank, collateralized
by accounts receivable, inventory and certain
fixed assets, due 1997 to 1998 123,456 256,054
9.62% Note payable to bank, collateralized by
accounts receivable, inventory and certain
fixed assets, due 1997 to 1999 97,529 145,861
-------------------------------
570,021 799,344
Less current portion 230,274 229,322
-------------------------------
Long-term debt $339,747 $570,022
===============================
Principal payments under the above debt obligations due subsequent to
December 31, 1997 are approximately as follows: $230,000 (1998); $104,000
(1999); and $236,000 (2000). The weighted average interest rate of the bank
debt outstanding as of December 31, 1997 and 1996 is 9.8% and 9.9%,
respectively. The difference between the fair value and the carrying value of
these debt obligations is immaterial.
(6) INCOME TAXES
The Company accounts for income taxes in accordance with Financial
Accounting Standards Board (FASB) Statement No. 109. The Company has no net
deferred taxes at December 31, 1997 and 1996 as the net deferred tax assets
(consisting of the tax effect of net operating loss carryforwards amounting to
approximately $2,048,000 and $2,148,000, respectively, tax credit carryforwards
of approximately $217,000 at both year ends and temporary differences relating
principally to depreciation) have been fully reserved for due to the
uncertainty of future taxable income.
At December 31, 1997 the Company had available net operating loss
carryforwards of approximately $5,120,000. The Company also had available at
December 31, 1997 approximately $217,000 of tax credits to reduce future
federal income taxes, if any. Approximately $940,000 of these net operating
loss and tax credit carryforwards expire from 1998 to 2002, and the remaining
$4,397,000 expire in 2003 through 2011. These carryforwards are subject to
review and possible adjustment by the Internal Revenue Service. The Tax Reform
Act of 1986 contains provisions which may limit the net operating loss
carryforwards available to be used in any given year in the event of certain
significant changes in ownership interests. The Company does not believe that
the cumulative effect of all ownership changes to date will reduce the
availability of its net operating loss carryforwards. In 1997 and 1995, the
Company's taxable income was fully offset by available net operating loss
carryforwards.
(7) STOCKHOLDERS' EQUITY
(a) Non-Qualified Stock Options
In April 1992, a total of 200,000 non-qualified stock options were issued
to the three executive officers of the Company at $1.05 per share, the then
current market price of the Company's common stock. These options, which were
granted outside of the stock option plans described below, expire in April
2002. Half of these options became exercisable in April 1993, and the
remaining half became exercisable in April 1994.
In November 1994, the Company entered into a non-exclusive investment
banking contract with Redwood MicroCap Fund of Colorado Springs, Colorado
("Redwood"). As compensation for services provided under this contract, the
Company issued 30,000 non-qualified stock options to Redwood, which are
exercisable at $1.45 per share as to 10,000 shares on and after November 2,
1995, an additional 10,000 shares on and after November 2, 1996, and the
remaining 10,000 shares on and after November 2, 1997. The options expire
completely to the extent not exercised on or before November 2, 1999.
(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.
Originally, 90,000 shares of common stock were reserved for issuance under the
1989 Plan; the stockholders of the Company approved an increase in this number
to 190,000 shares at the August 1992 Annual Meeting and a further increase in
this number to 290,000 shares at the June 1994 Annual Meeting. All options
granted under the 1989 Plan expire no later than ten years from the date of
grant.
In February 1990, the Board of Directors adopted the 1990 Stock Option
Plan for Outside Directors (the "1990 Plan"). The 1990 Plan was approved by
the stockholders of the Company on July 23, 1990. Under the 1990 Plan, each
director who was not an employee of the Company on the date the 1990 Plan was
adopted was automatically granted a non-qualified stock option to purchase
2,250 shares of common stock at the fair market value on the day preceding the
date of grant. Directors who were newly elected to the Board subsequent to
that date received an automatic grant of an option to purchase 2,250 shares, at
the fair market value on the day preceding the date of the grant. The 1990
Plan expired on February 2, 1995. The only grant of options outstanding
subsequent to the expiration of the 1990 Plan was exercised in full as to
2,250 shares during 1996.
In February 1995, the Board of Directors adopted the 1995 Stock Option
Plan for Outside Directors (the "1995 Plan"). The 1995 Plan was approved by the
stockholders of the Company on June 23, 1995. Under the 1995 Plan, each
director who was not an employee of the Company on the date the Plan was
adopted was automatically granted a non-qualified stock option to purchase
8,000 shares of common stock at its fair market value on the date of the grant.
Directors who are newly elected to the Board subsequent to February 1995
receive an automatic grant of an option to purchase 8,000 shares, at fair
market value on the date when such directors are first elected to the Board by
the stockholders. As of February 1995, 64,000 shares of common stock were
reserved for issuance under the 1995 Plan. Options to purchase an aggregate of
40,000 shares were automatically granted on the date the Plan was adopted by
the Board of Directors. Of these 40,000 options, 8,000 terminated in September
1995. Options to purchase another 8,000 shares were automatically granted on
June 23, 1995. One half of the shares subject to the options became
exercisable after the 1996 Annual Meeting of Stockholders, and the remaining
half of the shares subject to the options will become exercisable after the
1997 Annual Meeting of Stockholders. Options as to 4,000 of such shares were
exercised during 1997. All options granted under the 1995 Plan expire no
later than five years from the date of grant.
Activity under the stock option plans described above, was as follows:
Weighted Average
1989 Plan 1995 Plan 1990 Plan Exercise Price
--------- --------- --------- ----------------
Balance at
December 31, 1994 154,000 0 9,000 $2.18
Grants 84,000 48,000 -- 1.69
Terminations (46,750) (8,000) (6,750) 3.57
--------- -------- --------
Balance at
December 31, 1995 191,250 40,000 2,250 1.54
Grants 94,500 -- -- 3.44
Terminations (20,417) -- -- 1.37
Exercises (35,333) -- (2,250) 1.01
--------- ------- --------
Balance at
December 31, 1996 230,000 40,000 0 2.29
Grants 48,667 -- -- 2.48
Terminations (24,000) -- -- 3.40
Exercises (500) (4,000) -- 1.30
--------- -------- -------
Balance at
December 31, 1997 254,167 36,000 -- 2.25
========= ======== =======
Exercisable at
December 31, 1997 140,464 36,000 -- $1.92
========= ======== =======
At December 31, 1997, approximately 544,167 common shares were reserved
for future issuance under all warrants, stock options and stock option plans
described above.
(c) Compliance with Financial Accounting Standards Board New Accounting
Standard
In 1995, the Financial Accounting Standards Board ("FASB") issued
"Statement of Financial Accounting Standard (SFAS) No. 123 - Accounting for
Stock-Based Compensation". This statement requires a fair value based method
of accounting for employee and director stock options and would result in
expense recognition for the Company's stock plans. It also permits a Company
to continue to measure compensation expense for such plans using the intrinsic
value based method as prescribed by Accounting Principles Board Opinion No. 25
(APB 25), "Accounting for Stock Issued to Employees". The Company has elected
to follow APB No. 25 in accounting for its stock plans, and accordingly, no
compensation cost has been recognized.
Had compensation cost for the Company's stock plans been determined based
on the fair value requirements of SFAS No. 123, the Company's net profit (loss)
and basic net profit (loss) per share would have been reduced to the pro forma
amounts indicated below:
1997 1996 1995
---- ---- ----
Net profit (loss) As reported $263,852 $ (66,202) $29,811
Pro forma $211,072 $(176,263) $13,551
Basic net profit (loss)
per share As reported $ .11 $ (.03) $ .01
Pro forma $ .08 $ (.08) $ .01
The weighted average remaining life of the options outstanding under the
1989 Plan and the 1995 Plan as of December 31, 1997 was approximately 6.5
years. The exercise price of the options outstanding and of the options
exercisable as of December 31, 1997 ranged from $1.25 to $4.00. The weighted-
average grant date fair values of options granted during 1997 and 1996 were
$1.73 and $2.40 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 with the following weighted-average assumptions:
1997 1996 1995
---- ---- ----
Risk-free interest rate 5.7% 6.4% 6.4%
Dividend yield 0 0 0
Expected volatility 83.4% 89.3% 89.3%
Expected life 5 years 5 years 5 years
(d) Common Stock Rights Plan
On September 5, 1995, the Board of Directors of the Company adopted a
Common Stock 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. The dividend was distributed to the shareholders of record as
of the close of business on September 19, 1995. 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 become exercisable and transferrable 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 15 percent 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 acquisition of 15% or more of the Company's common stock by an
acquiring person, the holder of each Right not owned by the acquiring person
would be entitled to purchase common stock having a market value equal to two
times the exercise price of the Right (i.e., at a 50 percent discount). 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.
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 fourteen 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 $.005 per Right,
subject to adjustment. The Rights will expire on the earlier of (i) the close
of business on September 19, 2005, or (ii) the time at which the Rights are
redeemed by the Company.
(8) SEGMENT AND SIGNIFICANT CUSTOMER INFORMATION
The Company principally operates in the business segment described in
Note 1. The Company's primary customers for the majority of its 1997 product
sales (71%) are in the United States dairy and beef industries. Revenues
derived from foreign customers, who are also in the dairy and beef industries,
aggregated 28% of 1997 product sales.
Government grant income amounted to approximately 5% ($249,000), 7%
($321,000) and 12% ($577,000) of total revenues in the years ended December 31,
1997, 1996 and 1995, respectively.
(9) COMMITMENTS AND CONTINGENCIES
The Company has entered into employment contracts with its three
executive officers which could require the Company to pay from two to four
months' salary as severance pay depending upon the circumstances of any
termination of employment of these key employees.
In December 1993, the Company entered into a renewal of its service and
license agreement effective through December 31, 1999 with Kamar, Inc. whereby
Kamar will continue to provide the Company warehousing, distribution and
certain other services and the Company will continue to market a certain bovine
heat detection device under an exclusive world-wide license. The renewal
agreement is cancelable by either party upon twelve months written notice. The
Company is committed to pay Kamar a monthly fee for distribution services and
related license fees of $20,400 (adjusted annually for inflation) until the
license agreement is canceled. Royalties paid on sales made during the years
ended December 31, 1997, 1996 and 1995 were $188,000, $198,000 and $178,000,
respectively.
The research, manufacturing and marketing of human and animal health care
products by the Company entail an inherent risk that liability claims will be
asserted against the Company. The Company feels it has adequate levels of
liability insurance to support its operations.
(10) EMPLOYEE BENEFITS
The Company has 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 20% of their annual
compensation to the plan, subject to certain limitations. Beginning January 1,
1994, the Company has matched 50% of each employee's contribution to the plan
up to a maximum match of 3% of each employee's base compensation. Under this
matching contribution program, the Company paid the aggregate of $24,000,
$22,000 and $23,000 to the plan for the years ended December 31, 1997, 1996 and
1995, respectively. The Company intends to continue this same matching
contribution program in 1998.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange
Act of 1934, the Registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
IMMUCELL CORPORATION
Date: March 20, 1998 By: /S/ THOMAS C. HATCH
Thomas C. Hatch
President, Chief Executive
Officer and Director
POWER OF ATTORNEY
We, the undersigned directors and officers of ImmuCell Corporation hereby
severally constitute and appoint Thomas C. Hatch and Michael F. Brigham, and
each of them (with full power to each of them to act alone), our true and
lawful attorneys-in-fact and agents, 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
attorneys-in-fact and agents, and each of them, 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 attorneys-in-
fact and agents, or any of them, or their substitute or substitutes, may
lawfully do or to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated.
Date: March 20, 1998 By: /S/ MICHAEL F. BRIGHAM
Michael F. Brigham
Chief Financial Officer, Treasurer & Secretary
Date: March 20, 1998 By: /S/ ANTHONY B. CASHEN
Anthony B. Cashen, Director
Date: March 20, 1998 By: /S/ THOMAS C. HATCH
Thomas C. Hatch
President, Chief Executive Officer & Director
Date: March 20, 1998 By: /S/ GEORGE W. MASTERS
George W. Masters
Chairman of Board of Directors
Date: March 20, 1998 By: /S/ WILLIAM H. MAXWELL
William H. Maxwell, M.D., Director
Date: March 20, 1998 By: /S/ JOHN R. MCKERNAN
John R. McKernan, Jr., Director
Date: March 20, 1998 By: /S/ MITCHEL SAYARE
Mitchel Sayare, Director
IMMUCELL CORPORATION AND SUBSIDIARY
Exhibit Index
10.25 Amendment No. 5 to Agreement for Exclusivity between Advanced
Separation Technologies, Inc. and the Registrant dated October 2, 1997.
10.26 ****License Agreement between the Registrant and Murray Goulburn Co-
operative Co., Limited dated November 14, 1997.
23.1 Consent of Coopers & Lybrand L.L.P.
27.1 Financial Data Schedule (Filed Only Electronically).
****Confidential Treatment as to certain portions has been requested
effective until November 14, 2012. The copy filed as an exhibit omits the
information subject to the confidentiality request. The omitted
information has been deleted and replaced with [*].