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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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 June 30, 2002
OR
[ ] Transition Report Pursuant To Section 13 Or 15(d)
Of The Securities Exchange Act Of 1934
For the transition period from _________to __________
Commission File Number 1-4389
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Applera Corporation
(Exact name of registrant as specified in its charter)
DELAWARE 06-1534213
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
301 Merritt 7, Norwalk, Connecticut 06851-1070
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: 203-840-2000
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Securities registered pursuant to Section 12 (b) of the Act:
Name of Each Exchange
Title of Class on Which Registered
- ------------------------------------------------- --------------------------------------------
Applera Corporation - Applied Biosystems New York Stock Exchange
Group Common Stock (par value $0.01 per share) Pacific Exchange
Rights to Purchase Series A Participating New York Stock Exchange
Junior Preferred Stock (par value $0.01 per share) Pacific Exchange
Applera Corporation - Celera Genomics Group New York Stock Exchange
Common Stock (par value $0.01 per share) Pacific Exchange
Rights to Purchase Series B Participating New York Stock Exchange
Junior Preferred Stock (par value $0.01 per share) Pacific Exchange
Securities registered pursuant to Section 12 (g) of the Act:
Title of Class
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Class G Warrants
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. [X]
As of September 4, 2002, 208,797,987 shares of Applera Corporation -
Applied Biosystems Group Common Stock were outstanding, and the aggregate market
value of such shares (based upon the average of the high and low price) held by
non-affiliates was $3,778,158,063. As of September 4, 2002, 71,290,854
shares of Applera Corporation - Celera Genomics Group Common Stock were
outstanding, and the aggregate market value of such shares (based upon the
average of the high and low price) held by non-affiliates was $638,363,165.
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DOCUMENTS INCORPORATED BY REFERENCE
Annual Report to Stockholders for Fiscal Year ended June 30, 2002 -
Parts I, II, and IV. Proxy Statement for Annual Meeting of
Stockholders dated September 4, 2002 - Part III.
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PART I
Item 1. BUSINESS
General Development of Business
Applera Corporation (hereinafter referred to as the "Company") was
incorporated in 1998 under the laws of the State of Delaware. The Company
conducts its business through two groups: the Applied Biosystems Group ("Applied
Biosystems") and the Celera Genomics Group ("Celera Genomics"). In April 2001,
Applied Biosystems and Celera Genomics formed a joint venture in the field of
diagnostics ("Celera Diagnostics"). The Company maintains a corporate staff to
provide accounting, tax, treasury, legal, information technology, human
resources, and other internal services for Applied Biosystems, Celera Genomics,
and Celera Diagnostics.
The Company is the successor to PE Corporation (NY), formerly "The
Perkin-Elmer Corporation," which became a wholly owned subsidiary of the Company
as a result of a recapitalization of PE Corporation (NY) completed in May 1999.
As part of the recapitalization, the Company established two classes of common
stock that were intended to reflect separately the performance of the businesses
of each of Applied Biosystems and Celera Genomics (i.e., Applera Corporation -
Applied Biosystems Group Common Stock and Applera Corporation - Celera Genomics
Group Common Stock). Effective November 30, 2000, the Company, which was named
"PE Corporation" at the time of the recapitalization, was renamed "Applera
Corporation," and Applied Biosystems, which was named the "PE Biosystems Group"
at the time of the recapitalization, was renamed the "Applied Biosystems Group."
Applied Biosystems is engaged principally in the development,
manufacture, sale, and service of instrument-based systems, reagents, and
software, and the provision of contract services, for life science and related
applications. Its products are used in various applications including synthesis,
amplification, purification, isolation, analysis, and sequencing of nucleic
acids, proteins, and other biological molecules. The markets for Applied
Biosystems' products span the spectrum of the life sciences industry and
research community, including: basic human disease research; genetic analysis;
pharmaceutical drug discovery, development, and manufacturing; human
identification; agriculture; and food and environmental testing. Universities,
government agencies, and other non-profit organizations engaged in research
activities also use Applied Biosystems' products.
During the 2001 fiscal year, Applied Biosystems implemented an
organizational realignment away from a business unit structure organized
according to specific technologies to a more integrated marketing and product
development structure. During the 2002 fiscal year, Applied Biosystems
implemented further organizational changes intended to improve upon its new
marketing and product development structure. As part of these additional
organizational changes, in April 2002 Applied Biosystems announced the formation
of its new Knowledge Business for the purpose of developing and marketing
products and services designed to meet the needs of life science researchers in
performing specific biological analysis applications. Products and services
under development or expected to be developed by the Knowledge Business include
genomic assays and related information, as well as other information-rich
products, services, and analytical tools. Also in April 2002, Applied Biosystems
and Celera Genomics entered into a marketing and distribution agreement pursuant
to which Applied
Biosystems has become the exclusive marketer of Celera Genomics' Celera
Discovery System(TM) and related information assets as part of the Knowledge
Business.
Celera Genomics is engaged principally in integrating advanced
technologies to discover and develop new therapeutics. Celera Genomics intends
to leverage its capabilities in proteomics, bioinformatics, and genomics to
identify and validate drug targets and diagnostic marker candidates, and to
discover and develop novel therapeutic candidates. Celera Genomics was
originally formed for the purpose of generating and commercializing information
to accelerate the understanding of biological processes and to assist the
research endeavors of pharmaceutical, biotechnology, and life science research
entities. Celera Genomics' original business strategy was the development and
sale of its Celera Discovery System, an online information and discovery system
through which users can access Celera Genomics' genomic and related biological
and medical information. During the 2001 fiscal year, Celera Genomics announced
that it was expanding its operations to include a therapeutics discovery and
development business. During the 2002 fiscal year, Celera Genomics completed a
number of steps, including the following, to further develop its therapeutics
business and establish that business as its primary focus:
o In November 2001, Celera Genomics completed its acquisition of
Axys Pharmaceuticals, Inc. ("Axys"), a small molecule drug
discovery and development company. Celera Genomics believes
that Axys' medicinal and structural chemistry and biology
capabilities and preclinical programs will accelerate the
development of its therapeutics business.
o Celera Genomics announced a number of important management
changes. In January 2002, Celera Genomics announced the
resignation of J. Craig Venter as its President, and in April
2002, Celera Genomics announced the appointment of Kathy
Ordonez, who is also President of Celera Diagnostics, as his
replacement. Also in January 2002, Celera Genomics announced
the appointment of David Block as the Chief Operating Officer
of its therapeutics business. In July 2002, Celera Genomics
announced the appointment of Robert Booth as its Senior Vice
President of Research and Development to lead its therapeutics
research and development efforts.
o In April 2002, Celera Genomics and Applied Biosystems entered
into a marketing and distribution agreement pursuant to which
Applied Biosystems has become the exclusive marketer of Celera
Genomics' Celera Discovery System and related information
assets as part of Applied Biosystems' new Knowledge Business.
The agreement is expected to enable Celera Genomics' executive
team to focus on therapeutics discovery and development.
o Celera Genomics substantially increased the number of research
and development employees assigned to its therapeutics
programs. In addition, in June 2002, Celera Genomics announced
the implementation of a restructuring of its organization
intended to focus the group's resources on therapeutic
discovery and development. The restructuring also involved the
reduction of infrastructure, including personnel and
positions, previously built to support the group's sequencing
activities and online/information business.
Celera Diagnostics is focused on the discovery, development, and
commercialization of novel diagnostic products. In June 2002, Celera Diagnostics
announced the formation of a long-
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term strategic alliance with Abbott Laboratories to develop, manufacture, and
market a broad range of in vitro molecular diagnostic products for disease
detection, disease progression monitoring, and therapy selection.
In July 2001, the Company announced the Applera Genomics Initiative, a
collaboration among Celera Genomics, Applied Biosystems, and Celera Diagnostics
for commercializing products derived from information obtained through analysis
of variations in the human genome. The Company expects that these products will
be based on the identification of variations in the sequence and expression of
genes, and their association with disease and therapy. As part of this program,
Celera Genomics has prioritized and is resequencing approximately 25,000 genes
from 39 individuals and a chimpanzee, which the Company believes will reveal a
larger number of single nucleotide polymorphisms ("SNPs") with health related
implications than is currently available. SNPs are naturally occurring genetic
variations within a genome that scientists believe can be correlated with
susceptibility to disease, disease prognosis, therapeutic efficiency, and
therapeutic toxicity. Celera Genomics has identified over 100,000 SNPs to date,
a majority of which the Company believes have not been previously identified by
other researchers. In addition, Applied Biosystems has begun the process of
validating the SNPs identified by Celera Genomics to enable their use in
internal research and development and incorporation into commercial products and
services. Celera Genomics intends to use this SNP data in its internal discovery
efforts to improve the prediction of the efficacy and toxicity of drug
candidates. Applied Biosystems intends to use this information to develop new
assays for the study of SNPs and other polymorphisms, and gene expression and
other genomic products. Applied Biosystems' Knowledge Business may also
incorporate this data into its database offerings. Celera Diagnostics expects to
use this information in genotyping and gene expression studies ultimately aimed
at identifying new diagnostic markers. In July 2002, Applied Biosystems'
Knowledge Business announced the launch of its Assays-on-Demand(TM) products, a
collection of ready-to-use assays for gene expression and genotyping.
Assays-on-Demand products represent the first commercial products resulting from
the Applera Genomics Initiative, and the Company believes that Assays-on-Demand
is also the first commercial product line to incorporate genomic data from both
the public and private sector human genome sequencing projects.
Financial Information About Industry Segments
A summary of net revenues from external customers and operating income
(loss) attributable to each of the Company's industry segments for the fiscal
years ended June 30, 2000, 2001, and 2002, and total assets attributable to each
of the Company's industry segments for the fiscal years ended June 30, 2001 and
2002, is incorporated herein by reference to Note 14 on pages 71-83 of the
Company's Annual Report to Stockholders for the fiscal year ended June 30, 2002.
Total assets for the fiscal year ended June 30, 2000, were $1,698.2 million for
Applied Biosystems, $1,413.3 million for Celera Genomics, and $3,083.3 million
for the Company after the effects of ($28.2) million related to intercompany
eliminations. Celera Diagnostics has been presented as a segment during fiscal
2002, and fiscal 2001 amounts have been restated accordingly.
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Narrative Description of Business
Applied Biosystems Group
Overview. Applied Biosystems is engaged principally in the development,
manufacture, sale, and service of instrument-based systems, reagents, and
software, and the provision of contract services, for life science and related
applications. Its products are used in various applications including the
synthesis, amplification, purification, isolation, analysis, and sequencing of
nucleic acids, proteins, and other biological molecules. The markets for Applied
Biosystems' products span the spectrum of the life sciences industry and
research community, including: basic human disease research; genetic analysis;
pharmaceutical drug discovery, development, and manufacturing; human
identification; agriculture; and food and environmental testing. Universities,
government agencies, and other non-profit organizations engaged in research
activities also use Applied Biosystems' products. For information on revenues
from instruments and consumables for fiscal years 2000 through 2002, refer to
pages 22-24 of Management's Discussion and Analysis in the Company's Annual
Report to Stockholders for the fiscal year ended June 30, 2002, which pages are
incorporated herein by reference.
During the 2001 fiscal year, Applied Biosystems implemented an
organizational realignment away from a business unit structure organized
according to specific technologies to a more integrated marketing and product
development structure. During the 2002 fiscal year, Applied Biosystems
implemented further organizational changes intended to improve upon its new
marketing and product development structure. Under this structure, Applied
Biosystems' business operations are divided among several principal operating
units organized primarily according to their business function. These units are
responsible for various aspects of product and service discovery, development,
marketing, manufacturing, sales, and service. The operating activities of these
units are supported by a shared service organization responsible for the human
resources, finance, communications, legal, intellectual property, and advanced
research functions.
Scientific Background. All living organisms contain four basic
biological molecules: nucleic acids, which include DNA and RNA; proteins;
carbohydrates; and lipids. Biological molecules are typically much larger and
more complex than common molecules. These structural differences make the
analysis of biological molecules significantly more complex than the analysis of
smaller compounds. Although all of these biological molecules are critical for a
cell to function normally, key advances in therapeutics have historically come
from an understanding of either proteins or DNA.
DNA molecules provide instructions that ultimately control the
synthesis of proteins within a cell, a process referred to as gene expression.
DNA molecules consist of long chains of chemical subunits, called nucleotides.
There are four nucleotides - adenine, cytosine, guanine, and thymine - often
abbreviated with their first letters A, C, G, and T. DNA molecules consist of
two long chains of nucleotides bound together to form a double helix. Genes are
individual segments of these DNA molecules that carry the specific information
necessary to construct particular proteins. Genes may contain from several dozen
to tens of thousands of nucleotides. The entire collection of DNA in an
organism, called the genome, may contain a wide range of nucleotides, including
as few as 4 million nucleotides in the case of simple bacteria and 3.1 billion
base pairs of nucleotides in the case of human beings.
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RNA molecules are similar to DNA in structure and facilitate
intracellular function. There are different types of RNA molecules, each of
which has a different function. For example, messenger RNA, the most common form
of RNA, acts as an intermediary between DNA and protein, transcribing the
genetic code from DNA into protein.
Principally driven by the "biotechnology revolution," and the
increasing focus on DNA, researchers are developing a better understanding of
DNA's role in human disease. An increased appreciation of how DNA ultimately
determines the functions of living organisms has generated a worldwide effort to
identify and sequence genes of many organisms, including the genes that make up
the human genome. The Company believes the best scientific evidence to date
indicates that the number of genes in the human genome that code for proteins is
between 25,000 and 35,000, which is significantly less than had been previously
thought.
Individual research efforts in genetics generally fall into three broad
categories: sequencing, genotyping, and gene expression. In sequencing
procedures, the goal is to determine the exact order of the individual
nucleotides in a DNA strand so that this information can be related to the
genetic activity influenced by that piece of DNA. In genotyping, the goal is to
determine a particular sequence variant of a gene and its particular association
with an individual's DNA. Genotyping is not performed to determine the complete
structure of the gene, but rather is performed to determine if the particular
variant can be associated with a particular disease susceptibility or drug
response. In gene expression studies, the goal is to determine whether a
particular gene is expressed in a relevant biological tissue.
As researchers learn more about DNA and genes, they are also developing
a better understanding of the role of proteins in human disease through efforts
in the field of proteomics, the study of proteins expressed, or encoded, by
genes. Proteins are the products of genes and, after gene expression and
modification, are believed to be the key drivers and mediators of cellular
function and biological system activity. The understanding and treatment of
disease today involves the study of genes and the proteins they code for, and
frequently involves the measurement of a drug's ability to bind to specific
proteins in the body.
The Company believes that gene and protein research will increase as
companies in the pharmaceutical and biotechnology industries seek to accelerate
their drug discovery and development efforts. The Company also believes that
ongoing drug discovery and development efforts will increase research of cells
as researchers seek to further understand how drugs work in the body. These
efforts are expected to create a demand for increased automation and efficiency
in pharmaceutical and biotechnology laboratories. Applied Biosystems' products
are designed to address this demand by combining the detection capabilities of
analytical instruments with advances in automation and laboratory work-flow
design.
Knowledge Business; Online Marketing and Distribution Agreement with
Celera Genomics. In April 2002, Applied Biosystems announced the formation of
its new Knowledge Business for the purpose of developing and marketing products
and services designed to meet the needs of life science researchers in
performing specific biological analysis applications. Products and services
under development or expected to be developed by the Knowledge Business include:
genomic assays and related information, such as DNA sequence information and
annotations linking researchers to relevant databases; products for human
identification; products for agriculture, food, and environmental testing;
products for functional proteomics, the study of protein function; cellular
assays; as well as other information-rich products, services, and analytical
tools. The Knowledge Business is focused on generating value to life science
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customers through products and services with high information content that
support improved experimental work-flows.
Concurrently with Applied Biosystems' formation of the new Knowledge
Business in April 2002, Celera Genomics and Applied Biosystems entered into a
marketing and distribution agreement pursuant to which Applied Biosystems has
become the exclusive marketer of Celera Genomics' Celera Discovery System and
related information assets. Applied Biosystems is expected to integrate the
Celera Discovery System and other genomic and biological information into the
Knowledge Business.
In exchange for marketing and distribution rights to the Celera
Discovery System and other genomic and biological information and access to the
Celera Discovery System and related information, Applied Biosystems will provide
Celera Genomics with royalty payments on revenues generated by sales of certain
products of the Knowledge Business from July 1, 2002, through the end of fiscal
2012. The royalty rate is progressive, up to a maximum of 5%, with the level of
sales through fiscal 2008. The royalty rate becomes a fixed percentage of sales
starting in fiscal 2009, and the rate declines each succeeding fiscal year
through fiscal 2012. Assays-on-Demand, Assays-by-Design(SM), certain reagents
for arrays, and new database subscriptions sold by the Knowledge Business are
the products subject to royalties. Arrays are consumable devices used to perform
analysis that are designed for, and ready for introduction into, an analytical
instrument.
Under the terms of the marketing and distribution agreement, Celera
Genomics will receive all revenues under, and be responsible for all costs and
expenses associated with, Celera Discovery System and related information
contracts that were in effect on April 1, 2002, the effective date of the
agreement, or which were entered into during a three-month transition period
ended June 30, 2002 (as well as renewals of these contracts, if any). In
addition, Applied Biosystems has agreed to reimburse Celera Genomics for any
shortfall in earnings before interest, taxes, depreciation, and amortization
from these contracts below $62.5 million (as well as renewals, if any) during
the four fiscal years ending with the 2006 fiscal year if the shortfall is due
to changes made to Celera Discovery System products by or at the request of
Applied Biosystems, provided Celera Genomics otherwise continues to perform
under these contracts. During the term of the marketing and distribution
agreement (other than the transition period), Celera Genomics will not be
marketing Celera Discovery System products and services to, and will not be
contracting with, new customers.
Products for the Genomics Market. Customers in the genomics market use
systems for the analysis of nucleic acids for: basic research; pharmaceutical
and diagnostic discovery and development; food and environmental testing;
analysis of infectious diseases; and human identification and forensic analysis.
Applied Biosystems has developed technologies and products to support key
applications in sequencing, genotyping, and gene expression studies. The
following is a description of Applied Biosystems' products for the genomics
market:
o PCR Products. Polymerase chain reaction ("PCR") is a process
in which a short strand of DNA is copied multiple times, or
"amplified," so that it can be more readily detected and
analyzed. Applied Biosystems' PCR product line includes
amplification instruments, known as thermal cyclers, several
combination thermal cyclers and PCR detection systems, and
reagents and software necessary for the PCR amplification and
detection process.
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Applied Biosystems' model 9700 dual 384-well sample thermal
cycler is the highest capacity thermal cycler it offers. This
instrument supports all key applications in genetic analysis
and fills a significant market need for laboratories
conducting high volume genomic research. This instrument is
referred to as a "dual 384-well" instrument because it can
simultaneously amplify samples on two plastic cards, referred
to by researchers as microtiter plates, each having wells to
hold 384 samples. Applied Biosystems also offers 60 and 96
sample thermal cyclers.
Applied Biosystems is currently adapting its model 9700 dual
384-well thermal cycler to support a new proprietary
microfluidic card system, rather than microtiter plates, for
PCR-based assays, or analyses, such as TaqMan(R) assays
described below. The microfluidic card system is being jointly
developed with 3M Company. Applied Biosystems expects to
complete development and commence sales of the modified model
9700 and the microfluidic cards in the 2003 fiscal year.
Microfluidic cards are consumable laminated plastic sheets
containing microscopic fluid channels and wells. This
consumable, microscopic fluid channel design offers several
advantages:
o it requires less reagent for PCR amplification and
analysis;
o it enables researchers to introduce the initial
sample to a single main fluid channel, which
automatically routs the sample to the assay wells.
Scientists using microtiter plates must either
deposit samples into wells by hand, which is labor
intensive and time consuming, or using robotics,
which is expensive and complex; and
o assay reagents can be deposited on the microfluidic
cards before shipment to researchers, which
eliminates a time consuming step in experiment setup.
During the 2002 fiscal year, Applied Biosystems introduced new
PCR reagent products for high-fidelity, or high accuracy,
amplification of long DNA segments. These are useful in the
determination of haplotypes, which are correlated patterns of
inherited DNA mutations. Haplotypes are just beginning to be
understood by scientists and be used in complex disease-gene
association studies.
Applied Biosystems' Sequence Detection Systems(TM) product
line includes products both for sample preparation and for
analysis. Applied Biosystems' sample preparation products take
whole cells provided by a customer and extract DNA and/or RNA
from them. This DNA or RNA, largely separated from the other
molecules found in cells, can then be analyzed in instruments
largely without interference from those other molecules, such
as proteins. The Applied Biosystems model 6700 Automated
Nucleic Acid Workstation automates this phase of preparation
as well as the two other key phases, depositing the DNA and/or
RNA samples on assay plates and sealing those plates to avoid
contamination prior to analysis. The model 6700 is designed to
substantially decrease the labor and cost involved in
preparing DNA and RNA for analysis. During the 2002 fiscal
year, Applied Biosystems introduced the ABI PRISM(R) 6100
Nucleic Acid PrepStation. This instrument shares some features
of the model 6700, but is less automated and is designed for
researchers seeking an economical alternative to higher
performance, higher priced instruments.
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Applied Biosystems offers two Sequence Detection System
instruments for analysis of nucleic acids. The ABI PRISM
7900HT Sequence Detection System provides high throughput
analysis of DNA for gene expression and genotyping studies.
This is an automated analyzer that can process more than
250,000 samples in 24 hours for genotyping. Applied Biosystems
is currently developing an optional module for the model 7900,
allowing it to run assays implemented in the new proprietary
microfluidic card format. Applied Biosystems expects to
complete development and commence sales of the optional module
for the model 7900 and the microfluidic cards in the 2003
fiscal year. Also, during the 2002 fiscal year, Applied
Biosystems introduced the ABI PRISM 7000 Sequence Detection
System. This instrument offers many of the same specifications
as the model 7900, but in a less automated and lower
throughput system designed for researchers seeking an
economical alternative to higher performance and higher priced
instruments.
The Sequence Detection Systems product line uses TaqMan
chemistry, a unique PCR technology designed by the Roche Group
and developed by Applied Biosystems. TaqMan chemistry can be
used both for measurement of RNA gene expression and for DNA
genotyping. TaqMan chemistry detects the product of PCR
amplification and quantifies the initial sample during the
amplification process. This technique is referred to as
quantitative real-time PCR. The Sequence Detection Systems
instruments analyze a sample by measuring fluorescence
resulting from the reaction of the TaqMan chemistry and the
sample. This product line has been widely accepted in the
pharmaceutical discovery research market.
o Genetic Analysis Products. Genetic analysis uses
electrophoresis to separate DNA molecules based on their
differing lengths and the resulting differences in the speeds
at which they will pass through a separation medium. Applied
Biosystems' genetic analysis products, referred to as DNA
sequencers or genetic analyzers, can be used to perform both
DNA sequencing and fragment analysis.
DNA sequencing is used to determine the exact order of
nucleotides in a strand of DNA. Typically, fluorescent tags
are used to generate labeled products, with each of the four
different nucleotides labeled with a different color. The
labeled fragments are run through an electrophoresis
separation medium and detected. DNA fragment analysis is used
to determine the size, quantity, or pattern of DNA fragments.
DNA sequencing instruments have been used extensively to
obtain the DNA sequence of the human genome and of other
species. DNA sequencing instruments are also being used to
help interpret genomes that have been sequenced. For example,
as part of the Applera Genomics Initiative, Celera Genomics is
in the process of resequencing approximately 25,000 genes from
39 individuals and a chimpanzee to find the differences
between them. The Company believes this will reveal a larger
number of SNPs with health related implications than are
currently available.
All of Applied Biosystems' genetic analysis instruments now
use capillaries, which are tubes through which a DNA sample
moves during electrophoresis. Capillary systems have higher
throughput and greater automation than those based on
slab-gels, an older and less efficient technology. During the
2002 fiscal year, Applied Biosystems introduced three new DNA
sequencing instruments: the model 3730xl DNA Analyzer, a
sequencer with 96 capillaries; the model 3730 DNA Analyzer, a
sequencer with 48 capillaries; and the model 3100-Avant
Genetic Analyzer, a
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sequencer with 4 capillaries. In addition, Applied Biosystems
offers the model 3100 Genetic Analyzer, a 16 capillary
sequencer, and the model 310 Genetic Analyzer, a one capillary
sequencer, as well as sequencing reagents and analysis
software. Applied Biosystems has discontinued its model 377
DNA Sequencer, the last of its instruments to use slab-gel
technology.
The model 3730xl DNA Analyzer has superseded the 96 capillary
model 3700 DNA Analyzer. Applied Biosystems expects to
continue to offer the model 3700 only for a limited time
during the remainder of 2002. At the time of its introduction
in 1999, the model 3700 DNA Analyzer represented a significant
advance in DNA sequencing technology because it could perform
high throughput analysis of samples in unattended operation.
The model 3700 DNA Analyzer was the principal instrument used
by Celera Genomics for sequencing, and the Company believes
the model 3700 DNA Analyzer is also the principal instrument
used by the Human Genome Project for its sequencing projects.
The model 3730xl DNA Analyzer offers significant increases in
data quality, throughput, and cost effectiveness over the
model 3700 DNA Analyzer. Because of these advances, the model
3730xl DNA Analyzer is able to read longer DNA fragments than
its predecessor. For a given sequencing project, this means
that customers will need to process fewer samples, lowering
their preparation costs. Also, by incorporating a more
sensitive optical design, the model 3730xl is able to complete
the same analysis with lower reagent consumption per sample.
The 48-capillary model 3730 DNA Analyzer, which incorporates
the same technological advances as the model 3730xl, can be
upgraded to become a 96-capillary model 3730xl.
The 16-capillary model 3100 Genetic Analyzer was introduced in
the 2000 fiscal year. It was designed for use by academic
programs and commercial laboratories. It was the technological
precursor of the model 3730 DNA Analyzer and incorporates many
of the same features, though it has lower throughput and is
less expensive. The 4-capillary model 3100-Avant Genetic
Analyzer is a reduced capacity instrument derived from the
model 3100 Genetic Analyzer, which has a lower cost than the
model 3100. A model 3100-Avant Genetic Analyzer can be
upgraded to a model 3100.
Applied Biosystems offers several sequencing chemistries
optimized for various customer requirements. Samples prepared
using these chemistries are then analyzed on Applied
Biosystems sequencer instruments.
o DNA Synthesis. DNA synthesizers produce synthetic polymers of
DNA, called oligonucleotides, for genetic analysis. The
synthetic DNA is an essential reagent for PCR and DNA
sequencing and is also used in drug discovery applications.
DNA synthesis is used both by companies performing high
throughput synthesis as a service as well as individual
laboratories that synthesize DNA for their own use. Applied
Biosystems offers several models of synthesizers and
supporting reagents for the needs of its different customers.
Applied Biosystems also provides custom synthesis, in which
oligonucleotides are made to order and shipped to customers.
o PNA. Applied Biosystems has a license, which is exclusive for
certain applications, to manufacture and sell peptide nucleic
acid ("PNA") for molecular biology research, diagnostic, and
certain other applications. PNA resembles DNA in its chemical
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structure except that it has a neutral peptide-like
"backbone," whereas DNA has a negatively charged sugar
phosphate backbone. The unique chemical structure of PNA
enhances its affinity and specificity as a DNA or RNA probe,
which is used to search for DNA and RNA sequences, which are
complementary to the probe. PNA may be used in many areas,
including basic research, pharmaceutical discovery, diagnostic
development, and food and environmental testing. During the
2002 fiscal year, Applied Biosystems acquired additional
rights to PNA technology, particularly exclusive rights in the
field of diagnostics, through its acquisition of Boston
Probes, Inc. and a party related to Boston Probes.
o Genomic Assays. Through its Knowledge Business, Applied
Biosystems offers its Assays-on-Demand product lines and its
Assays-by-Design service. Assays are chemical tests used to
measure a particular biochemical quantity. A genomic assay
combines a set of pre-selected oligonucleotides, or synthetic
polymers of DNA, with other analytical reagents that allow a
researcher to measure differences between samples of genetic
material. For example, a gene expression assay is a chemical
test to measure how much RNA is being produced from a specific
gene in the cells of a tissue sample. A genotyping assay is a
chemical test to measure the presence or absence of a specific
genetic sequence variation or mutation among DNA samples from
different populations that can be used to correlate genetic
traits with physical traits such as disease susceptibility or
drug response.
In July 2002, the Knowledge Business announced the launch of
its Assays-on-Demand product line, a collection of assays for
gene expression and genotyping that incorporates genome data
into a tool that is ready to use for experimentation.
Assays-on-Demand is the first commercial product resulting
from the Applera Genomics Initiative, and Applied Biosystems
believes that Assays-on-Demand is also the first commercial
product line to incorporate genomic data from both the public
and private sector human genome sequencing projects. The
Knowledge Business also offers the Assays-by-Design service
for the manufacture of custom-made assays. Researchers using
the Assays-by-Design service supply the desired target and
Applied Biosystems designs and manufactures an assay for that
target using Applied Biosystems' proprietary software
algorithms.
Researchers traditionally have used "home brew" assays, which
are assays that researchers both design and prepare themselves
in their laboratories, a process that is relatively time
consuming and expensive. Applied Biosystems believes that its
Assays-on-Demand product line offers significant advantages to
researchers compared with home brew assay design. These
advantages include:
o facilitation of experiments with many genes in
parallel;
o substantial reduction in experiment setup time;
o decreased assay cost; and
o creation of a set of standard and validated assays
that enable comparisons of data between laboratories.
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Applied Biosystems' current Assays-on-Demand and
Assays-by-Design offerings are designed to be used with
Applied Biosystems' Sequence Detection Systems PCR
instruments.
Products for the Proteomics Market. Genes code for proteins in
biological organisms, and proteins are the key biological molecules that
function in all aspects of living things such as growth, development, and
reproduction. Differences in the types or amounts of specific proteins in
biological systems are thought to be the primary differences between healthy and
diseased systems or organs. A majority of drugs to treat human disease bind to
and affect proteins. Proteins are large biological molecules made up of
peptides, and peptides are made up of amino acids chemically linked together in
long chains. Customers in the proteomics research market need systems for the
analysis of proteins and peptides for the purpose of discovery of drug targets,
protein therapeutics, and diagnostics. Applied Biosystems has developed products
for the identification, characterization, and measurement of expression of
proteins and peptides. The following is a description of Applied Biosystems'
products for the proteomics market:
o Mass Spectrometry. Mass spectrometry has become very useful
for the analysis of large molecules of biological importance
such as proteins. Analysis of proteins and other molecules by
mass spectrometry involves the very accurate measurement of
the mass, or size, of components in a sample, such as the
measurement of the multiple different peptides that make up a
defective protein. The technique involves the measurement of
these molecules in instruments utilizing very high vacuum and
sensitive electronics capable of measuring extremely fine
differences in very small quantities of complex samples with
multiple components. The technique of mass spectrometry
requires three key elements be incorporated into the
instrument:
o a unique sample preparation process call ionization
to charge the molecules for analysis;
o mass analysis, which involves the separation of
molecules based on their mass; and
o detection, which is the electronic measurement of the
mass and the relative amounts of molecule present.
The market for mass spectrometry is served by a wide range of
instrument types based on a variety of technologies for both
ionization and mass analysis and combined together in
different combinations in different instruments. The different
instrument types, technologies, and combinations result in
differing performance characteristics and price levels, and
the suitability of any particular system for any researcher or
research laboratory will depend on the nature of the work
being performed and the capital budget of the researcher or
research laboratory.
Applied Biosystems sells instruments with ionization by either
a laser based system called MALDI, which refers to matrix
assisted laser desorption ionization, or a high voltage
electric system called ESI, which refers to electrospray
ionization. Applied Biosystems also has a variety of mass
analysis technologies which separate and measure the mass of
molecules in a sample. These include TOF, which refers to time
of flight, which measures mass based on flight time in an
electric field under vacuum; and quad, which refers to
quadrupole, and ion trap, both of which measure
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mass using radio frequencies and electric charges though using
distinctly different technologies. Applied Biosystems and
Applied Biosystems/MDS SCIEX Instruments, a joint venture
between Applied Biosystems and MDS Inc. of Canada, supply a
broad family of mass spectrometry products for the proteomics
market that involve different combinations of these
technologies. Customers select from this range of product
types based on their workflows, sample types, preferences, and
experience.
Mass spectrometry products are often referred to or named
based on their sample preparation and mass analysis
technologies. For example, a "MALDI TOF" instrument is an
instrument that uses MALDI to charge molecules for analysis
and TOF for mass analysis. Also, mass spectrometry instruments
are often referred to or named based on whether they are
connected to liquid chromatography separation devices, which
devices are used for sample preparation prior to analysis
using mass spectrometry. An "LC/MS" system is a liquid
chromatography device connected directly to a mass
spectrometry instrument, and an "LC/MS/MS" system is a liquid
chromatography device coupled with tandem mass spectrometry
instruments. Tandem mass spectrometry enables a more detailed
and accurate analysis of the components of the molecules being
studied.
The Applied Biosystems MALDI TOF product line includes the
Voyager(TM) DE STR and DE PRO instruments and the Voyager
based Proteomics Solution 1(TM) systems for automated protein
identification. During the 2002 fiscal year, Applied
Biosystems introduced the 4700 Proteomics Analyzer with
TOF/TOF(TM) optics, which was designed to address the needs of
proteomic researchers for increased speed and throughput as
well as enhanced data quality and molecular information. This
instrument incorporates a new high speed MALDI system with a
tandem TOF mass analyzer, and Applied Biosystems believes it
is the only instrument currently available that offers this
combination of these advanced features.
The ESI based product line from Applied Biosystems/MDS SCIEX
Instruments includes the API QSTAR(R) Pulsar LC/MS/MS system
which is a hybrid quadrupole - time of flight instrument
(often referred to as a Qq-TOF instrument). The API QSTAR
Pulsar LC/MS/MS system offers a choice of sample introduction
technologies and therefore is a highly flexible life science
mass spectrometer and proteomics instrument. During the 2002
fiscal year, Applied Biosystems/MDS SCIEX Instruments
introduced the Q TRAP(TM) LC/MS/MS system, which uses ESI
ionization. Applied Biosystems believes that this new mass
spectrometer, which can be used for both protein and small
molecule analysis, has performance advantages over
competitively priced mass spectrometry instruments. Under the
terms of the joint venture agreement with MDS Inc., Applied
Biosystems has the exclusive worldwide distribution rights to
the LC/MS systems manufactured for the joint venture by the
MDS SCIEX Division of MDS Inc. for the analytical instruments
market.
In addition to the range of mass spectrometry instruments and
software, Applied Biosystems has developed and commercialized
the ICAT(TM) reagent technology of Dr. Ruedi Aebersold and
others at the University of Washington. This chemistry
technology, when utilized with various mass spectrometry
systems, enables the quantitation and identification of
proteins in experiments that compare normal and
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diseased cells or samples. The ICAT reagent approach now
offers laboratories a new way of running protein experiments
using mass spectrometry and is the foundation of an expanding
family of Applied Biosystems consumables, software, and
systems for proteomics.
o Biochromatography. Researchers studying complex protein
samples through mass spectrometry must first prepare these
samples and separate them into the components to be analyzed.
A common and important technique for the separation, and in
some cases purification, of biological molecules is generally
referred to as biochromatography, a process by which molecules
are separated according to one or more of their physical
properties such as their size, shape, charge, or affinity to
other molecules.
Applied Biosystems' biochromatography products use liquid
chromatography. Liquid chromatography is a process that
separates molecules by passing them, in a liquid, across a
stationary or solid medium such as chemically modified plastic
beads specially designed for this process. Separation occurs
because different molecules, which have different affinities
to the beads, will migrate, or pass, across the beads at
different rates. Instruments that perform liquid
chromatography under high pressure are referred to as high
pressure liquid chromatography, or HPLC, instruments.
Applied Biosystems believes that its biochromatography
products can be incorporated readily into the proteomics
discovery process and the development and manufacturing
process of protein based pharmaceutical products. Applied
Biosystems also believes its biochromatography products offer
productivity advantages, enabled by high speed separation
combined with high capacity and resolution, over competitive
product offerings.
Applied Biosystems' patented Perfusion Chromatography(R)
technology uses proprietary flow-through POROS(R) beads and
BioCad(R) Chromatography workstations to reduce the time
necessary for the purification and analysis of biological
molecules. Applied Biosystems' Vision(TM) Workstation is a
robotic-equipped chromatography instrument marketed to life
science researchers that allows for the separation of proteins
followed by analysis of the fractions collected in an
unattended operation. Together, the automated platform and
flow-through beads are designed to increase throughput and
efficiency for the separation and purification of biological
molecules.
o Protein Sequencing and Synthesis. Proteins are large
biological molecules and are made of peptides, and peptides
are made of amino acids chemically linked together in long
chains. Protein sequencers provide information about the
sequence of amino acids that make up a given protein by
chemically disassembling the protein and analyzing the amino
acids. The Procise(R) Protein Sequencing system uses a protein
sequencing chemistry known as Edman chemistry to sequence a
peptide, one amino acid at a time, and in turn to identify or
characterize the protein that contains the peptide.
Synthetically produced peptides are used in understanding
antibody reactions and as potential drugs or drug analogs.
Applied Biosystems' 433A Peptide Synthesis system is designed
for the quality synthesis of peptides, peptide analogs, and
small
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proteins. Applied Biosystems also manufactures and sells
proprietary synthesis reagents and fine chemicals for use with
this and other products.
Products for the Drug Metabolism and Pharmacokinetics Market. Applied
Biosystems has a number of mass spectrometry products that life science
researchers use to analyze small molecules. Small molecules studied in life
science research are typically smaller than peptides and include, for example:
o drugs;
o metabolites, the compounds resulting from the body's acting
upon a drug, and present in bodily fluids such as blood or
urine; and
o other small biological molecules found naturally in the human
body such as hormones, which affect physiological activity by
sending signals to cells and organs, and cholesterol, which
the body uses, for example, to build cells and produce
hormones.
Mass spectrometry instruments are especially important for
pharmaceutical researchers studying pharmacokinetics, the measurement of the
bodily absorption, distribution, metabolism, and excretion of drugs.
Pharmacokinetic information is required by the United States Food and Drug
Administration and other regulatory agencies for the approval of drugs. This
application requires instruments which have a high resolution, or the ability to
distinguish among different molecules with similar masses, and high sensitivity,
or the ability to identify very small quantities of molecules, because the
amounts of the drugs and their metabolites are very low and the mixtures are
very complex. Researchers can perform the required pharmacokinetic analysis with
LC/MS/MS systems that have been developed and refined by Applied Biosystems/MDS
SCIEX Instruments.
Applied Biosystems/MDS SCIEX Instruments offers a broad product line
for small molecule and pharmacokinetics researchers. This product line includes
the API 2000(TM), API 3000(TM), and API 4000(TM) systems, all of which are
triple quadrupole LC/MS/MS instruments. These instruments offer a range of
sensitivity at varying costs, the API 4000 system being the most sensitive. The
API product line has been widely accepted by pharmaceutical researchers, and the
Company believes the API 4000 system is the most sensitive mass spectrometry
instrument available to this research market. Applied Biosystems/MDS SCIEX
Instruments also offers API QSTAR Pulsar LC/MS/MS system, which is a quadrupole
- - time of flight instrument (often referred to as a Qq-TOF instrument). This
instrument offers higher resolution and mass accuracy, or the ability to
accurately determine the mass of a molecule, than the API 2000, 3000, and 4000
systems, which is particularly useful to researchers seeking to identify unknown
molecules such as metabolites.
In the 2002 fiscal year, Applied Biosystems/MDS SCIEX Instruments
introduced the Q TRAP(TM) LC/MS/MS system, which uses ESI ionization. Applied
Biosystems believes that this new mass spectrometer, which can be used for both
protein and small molecule analysis, has advantages over competitively priced
mass spectrometry instruments.
Cell Biology and Functional Proteomics Products. Within the Knowledge
Business, a new product group has been formed to develop products for early
phase drug discovery and development. This group is focused on products that
reveal gene and protein function. This
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group also intends to develop products that reveal the biological reactions that
take place in cells, which researchers refer to as biological pathways. Some
scientists believe that a better understanding of this information may enable
structure based drug design, which refers to the design of drugs based on the
molecular structure of the intended drug target. This method can be contrasted
with the traditional approach to drug development, whereby researchers seek to
determine whether chemicals may work as drugs through trial-and-error
experimentation. The following is a description of the existing products of this
group as well as certain products in development:
o Cell Based Detection Systems. Through its strategic alliance
with Becton, Dickinson and Company, Applied Biosystems has
co-developed a fluorometric microvolume assay technology
system, referred to as an FMAT system. This instrument system
uses proprietary scanning technology to rapidly detect and
measure fluorescence associated with objects as small as a
single cell. This system was designed for pharmaceutical
researchers needing a high throughput screening system for the
analysis of cells.
o Chemiluminescence Products. Applied Biosystems' high
throughput screening products include reagents and
chemiluminescent plate readers that measure light emitted by a
sample. Chemiluminescence is the conversion of chemical energy
stored within a molecule into light. Chemiluminescent
substrates are substances that emit light in the presence of
another target substance that is tagged, or chemically linked,
with an enzyme. Chemiluminescent technology is used in life
science research and commercial applications including drug
discovery and development, clinical diagnostics, gene function
study, molecular biology, and immunology research. Applied
Biosystems also licenses its technology to companies selling
bioanalytical and clinical diagnostic tests.
o Functional Proteomics Products. During the 2002 fiscal year,
Applied Biosystems entered into licensing, supply, and
collaboration agreements with HTS Biosystems, Inc. to jointly
develop and commercialize a functional proteomics system based
on HTS Biosystems' high throughput affinity screening
technology. This technology enables functional proteomics
research, or the study of protein function, by analyzing
proteins based on the way they bind to each other. Under these
agreements, Applied Biosystems and HTS Biosystems also plan to
jointly further develop and commercialize HTS Biosystems'
existing surface plasmon resonance technology, referred to as
SPR technology. SPR technology, used in functional genomics
research, or the study of gene function, enables the high
throughput study of protein interactions in a more
cost-effective and efficient manner than other existing
technologies. The study of protein interactions is an
important part of functional genomics research because genes
contain the code for proteins.
Applied Genetic Analysis Products. Applied Biosystems has developed,
and expects to continue to develop, products and services specially designed for
specific markets, with a focus in the areas of human identification, and
environmental and food testing.
For example, Applied Biosystems develops systems that are used by crime
laboratories and other agencies to identify individuals based on their DNA.
Applied Biosystems believes these systems are most often used in cases of
violent crime where DNA found at the crime scene is matched with DNA from
suspects. The use of DNA in some criminal investigations may help
-15-
solve the crimes and may reduce the cost of the investigation, and the Company
believes there is a growing recognition of the validity of the use of DNA
testing and DNA databases for this purpose. The systems are also used in the
identification of human remains at disaster sites.
Also, Applied Biosystems is developing technologies for bacterial and
fungal detection, characterization, and identification. It has developed the
MicroSeq 16S rDNA Bacterial Sequencing Kit to accurately identify
microorganisms. TaqMan Pathogen Detection Kits relying on Sequence Detection
Systems instrument platforms are under development. These kits are being
developed to rapidly detect bacterial contamination and to detect and analyze
genetically modified organisms in foods.
Information Products. The Knowledge Business currently offers, and
intends to further develop, products that offer information content designed to
assist research and development efforts. The information products currently
offered by the Knowledge Business include the Celera Discovery System database,
as well as software, for use in combination with the Knowledge Business assay
products, designed to facilitate and make more efficient experiment design and
biological data analysis.
Informatics Products and Services. The Knowledge Business develops,
markets, and distributes informatics software and services used to integrate and
automate life sciences research, development, and manufacturing laboratories.
The science of informatics seeks to blend biology and computing to transform
massive amounts of data into useful information. Informatics technology that is
specifically designed for biological information is commonly referred to as
bioinformatics technology.
Users of Knowledge Business informatics products and services are
typically involved in gene mapping, drug discovery, drug development, and drug
manufacturing. The Knowledge Business offers various software products for
laboratory information management. These products are designed to facilitate
sample tracking, data collection, data analysis, and data mining. The Knowledge
Business also offers informatics consulting services through its Rapid
Integration Solutions Program. These system integration services are designed
for laboratories seeking greater automation and integration of lab processes.
Knowledge Business consultants assist customers in selecting and integrating
technologies to streamline and accelerate their genomics, proteomics, and high
throughput screening activities.
Marketing and Distribution. The markets for Applied Biosystems'
products and services span the spectrum of the life sciences industry,
including: basic human disease research; genetic analysis; pharmaceutical drug
discovery, development, and manufacturing; human identification; agriculture;
and food and environmental testing. Universities, government agencies, and other
non-profit organizations engaged in research activities also use Applied
Biosystems' products. Each of these markets has unique requirements and
expectations that Applied Biosystems seeks to address in its product offerings.
Applied Biosystems' customers are continually searching for processes and
systems that can perform tests faster, more efficiently, and at lower costs.
Applied Biosystems believes that its focus on automated and high throughput
systems enables it to respond to these needs.
The size and growth of Applied Biosystems' markets are influenced by a
number of factors, including:
o technological innovation in methods for analyzing biological
data;
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o government funding for basic and disease-related research,
such as in heart disease, AIDS, and cancer;
o application of biotechnology to basic agricultural processes;
o increased awareness of biological contamination in food and
the environment; and
o research and development spending by biotechnology and
pharmaceutical companies.
In the United States, Applied Biosystems markets the largest portion of
its products directly through its own sales and distribution organizations,
although certain products are marketed through independent distributors and
sales representatives. Sales to major markets outside of the United States are
generally made by Applied Biosystems' foreign-based sales and service staff, but
are also made directly from the United States to foreign customers in some
cases. In some foreign countries, sales are made through various representative
and distributorship arrangements. Applied Biosystems owns or leases sales and
service offices in the United States and in foreign countries through its
foreign sales subsidiaries and distribution operations. None of Applied
Biosystems' products are distributed through retail outlets.
Raw Materials. There are no specialized raw materials that are
particularly essential to the operation of Applied Biosystems' business. Applied
Biosystems' manufacturing operations require a wide variety of raw materials,
electronic and mechanical components, chemical and biochemical materials, and
other supplies, some of which are occasionally found to be in short supply.
Applied Biosystems has multiple commercial sources for most components and
supplies, but it is dependent on single sources for a limited number of such
items, in which case Applied Biosystems normally secures long-term supply
contracts. In some cases, if a supplier discontinues a product, it could
temporarily interrupt the business of Applied Biosystems.
Patents, Licenses, and Franchises. Applied Biosystems' products are
based on complex, rapidly developing technologies. Some of these technologies
are covered by patents owned by Applied Biosystems, and others are owned by
third parties and used by Applied Biosystems under license. Applied Biosystems
has pursued a policy of seeking patent protection in the United States and other
countries for developments, improvements, and inventions originating within its
organization that are incorporated into Applied Biosystems' products or that
fall within its fields of interest. Applied Biosystems' business depends on its
ability to continue developing new technologies which can be patented, or
licensing new technologies from third parties that own patents in such
technologies. The rights that Applied Biosystems considers important to its
current business include the following:
o Applied Biosystems has rights to PCR technology under a series
of agreements with the Roche Group, which owns the patents
covering the PCR process. The first of these patents expires
in 2005 in the United States, and in 2006 in Europe and
certain other jurisdictions. In July 2000, Applied Biosystems
and the Roche Group agreed to expand the markets each company
serves with products incorporating PCR. This arrangement will
allow both companies to develop and market products for all
potential uses of PCR. Additionally, Applied Biosystems
continues to distribute products the Roche Group manufactures
for research and non-diagnostic applications.
-17-
o Applied Biosystems also licenses rights under certain patents
assigned to the California Institute of Technology relating to
DNA sequencing. These patents expire between 2009 and 2018 in
the United States, and in 2005 in Europe and certain other
jurisdictions.
o Applied Biosystems also licenses rights under certain patents
assigned to the University of Colorado relating to
oligonucleotide synthesis. The last of these patents in the
United States will expire in 2007. The corresponding foreign
patents have expired except for certain patents in Canada and
Mexico, which expire in 2003.
From time to time, Applied Biosystems has asserted that various
competitors and others are infringing its patents; and similarly, from time to
time, others have asserted that Applied Biosystems was or is infringing patents
owned by them. These claims are sometimes settled by mutual agreement on a
satisfactory basis and result in the granting of licenses by or to Applied
Biosystems. However, the Company cannot make any assurances as to the outcome of
any pending or future claims.
Applied Biosystems has established a licensing program that provides
industry access to certain of its intellectual property.
Backlog. Applied Biosystems' total recorded backlog at June 30, 2001,
was $202.3 million, which included $5.0 million of orders from Celera Genomics.
Applied Biosystems' total recorded backlog at June 30, 2002 was $235.8 million,
which included $4.6 million of orders from Celera Genomics and $3.0 million of
orders from Celera Diagnostics. It is Applied Biosystems' general policy to
include in backlog only purchase orders or production releases that have firm
delivery dates within one year. Recorded backlog may not result in sales because
of cancellation or other factors. It is anticipated that all orders included in
the current backlog will be delivered before the close of fiscal year 2003.
Competition. The markets in which Applied Biosystems operates are
highly competitive and are characterized by the application of advanced
technology. A number of Applied Biosystems' competitors are well known
manufacturers with a high degree of technical proficiency. In addition,
competition is intensified by the ever-changing nature of the technologies in
the industries in which Applied Biosystems is engaged.
Applied Biosystems' principal competition comes from specialized
manufacturers that have strengths in narrow segments of the life science
markets. Applied Biosystems competes principally in terms of the breadth and
quality of its product offerings, and its service and distribution capabilities.
While the absence of reliable statistics makes it difficult to determine Applied
Biosystems' relative market position in its industry segment, Applied Biosystems
believes it is one of the principal suppliers in its fields, marketing a broad
line of instruments and life science systems.
Research, Development, and Engineering. Applied Biosystems is actively
engaged in basic and applied research, development, and engineering programs
designed to develop new products and to improve existing products. Research,
development, and engineering expenses for Applied Biosystems totaled $141.2
million in fiscal 2000, $184.5 million in fiscal 2001, and $219.6 million in
fiscal 2002. The Company expensed $255.6 million in fiscal 2000, $323.4
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million in fiscal 2001, and $381.9 million in fiscal 2002 for Company-sponsored
research, development, and engineering activities.
Applied Biosystems' new products generally originate from four sources:
internal research and development programs; external collaborative efforts with
technology companies and individuals in academic institutions; devices or
techniques that are generated in customers' laboratories; and business and
technology acquisitions.
Research and development projects at Applied Biosystems include: the
development of improved electrophoresis techniques for DNA analysis; real-time
PCR for nucleic acid quantification; innovative approaches to cellular analysis;
sample preparation; information technologies; and mass spectrometry.
Environmental Matters. Applied Biosystems is subject to federal, state,
and local laws and regulations regulating the discharge of materials into the
environment, or otherwise relating to the protection of the environment, in
those jurisdictions where Applied Biosystems operates or maintains facilities.
Applied Biosystems does not believe that any liability arising under, or
compliance with, environmental laws or regulations will have a material effect
on its business, and no material capital expenditures are expected for
environmental control.
Celera Genomics Group
Overview. Celera Genomics is engaged principally in integrating
advanced technologies to discover and develop new therapeutics. Celera Genomics
intends to leverage its capabilities in proteomics, bioinformatics, and genomics
to identify and validate drug targets and diagnostic marker candidates, and to
discover and develop novel therapeutic candidates. Celera Genomics expects to
use these capabilities with its molecular and cell biology, medicinal and
computational chemistry, pharmacology, and other drug development technologies
to optimize the potency, selectivity, and physical properties of new drug
candidates. Currently, Celera Genomics has collaborations with large
pharmaceutical companies and internal programs for discovering therapeutics for
inflammatory diseases, including asthma, osteoporosis, and rheumatoid arthritis.
Celera Genomics also has internal programs for discovering therapeutics for the
treatment of thrombosis and various types of cancer, including pancreatic and
lung cancer.
Celera Genomics was originally formed for the purpose of generating and
commercializing information to accelerate the understanding of biological
processes and to assist the research endeavors of pharmaceutical, biotechnology,
and life science research entities. A key component of Celera Genomics' original
business strategy was the development and sale of its Celera Discovery System,
an online information and discovery system through which users can access Celera
Genomics' genomic and related biological and medical information.
Development of Therapeutics Business. During its 2001 fiscal year,
Celera Genomics announced that it was expanding its operations to include
therapeutics discovery and development in addition to its online database
business. During the 2002 fiscal year, Celera Genomics completed a number of
steps, including the following, to further develop its therapeutics business and
establish that business as its primary focus:
o In November 2001, Celera Genomics completed the acquisition of
Axys, a small molecule drug discovery and development company.
Celera Genomics believes that
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Axys' medicinal and structural chemistry and biology
capabilities and preclinical programs will accelerate the
development of its therapeutics business.
o Celera Genomics announced a number of important management
changes. In January 2002, Celera Genomics announced the
resignation of J. Craig Venter, Ph.D. as its President, and in
April 2002, Celera Genomics announced the appointment of Kathy
Ordonez, who is also President of Celera Diagnostics, as his
replacement. Before her affiliation with the Company, Ms.
Ordonez served as the President and Chief Executive Officer of
Roche Molecular Systems for nine years. Also in January 2002,
Celera Genomics announced the appointment of David Block,
M.D., as the Chief Operating Officer of its therapeutics
business. Prior to his employment by the Company, Dr. Block
was employed by DuPont Pharmaceuticals in various capacities
for approximately 12 years, including Vice President for
International Operations. In July 2002, Celera Genomics
announced the appointment of Robert Booth, Ph.D., as its
Senior Vice President of Research and Development to lead its
therapeutics research and development efforts. Prior to his
appointment by the Company, Dr. Booth was employed by
Hoffmann-La Roche in various capacities for approximately 13
years, including as Senior Vice President responsible for all
research and early development of inflammatory, viral,
respiratory, and bone disease products.
o In April 2002, Celera Genomics and Applied Biosystems entered
into a marketing and distribution agreement pursuant to which
Applied Biosystems has become the exclusive marketer of Celera
Genomics' Celera Discovery System and related information
assets as part of Applied Biosystems' new Knowledge Business.
The agreement is expected to enable Celera Genomics' executive
team to focus on therapeutic discovery and development.
o Celera Genomics substantially increased the number of research
and development employees assigned to therapeutic programs.
Also, in June 2002, Celera Genomics announced the
implementation of a restructuring of its organization intended
to focus the group's resources on therapeutic discovery and
development. The restructuring also involved the reduction of
infrastructure, including personnel and positions, previously
built to support the group's sequencing activities and
online/information business.
Celera Genomics may pursue both small molecule and antibody
therapeutics. Small molecule therapeutics are low molecular weight synthetic
pharmaceuticals, whereas antibody therapeutics are generally large molecular
weight protein-based biological compounds. Celera Genomics plans to
commercialize discoveries, either at the target or therapeutic level, through
internal product development, collaborations, or licensing of intellectual
property.
Scientific Approach to Discovery. Celera Genomics expects its
scientific approach in therapeutic discovery to be as follows:
o Proteomics. Celera Genomics expects that its discovery program
will use high throughput proteomics to identify proteins which
are associated with the onset or progression of disease, and
which may therefore be potential targets for therapeutic
intervention or markers for disease detection or progression.
In the 2002 fiscal year,
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Celera Genomics completed the construction of its proteomics
facility. Celera Genomics is currently scaling up the
operations of the proteomics facility, which is expected to
become fully operational during the Company's 2003 fiscal
year. Using its proteomics technology, Celera Genomics plans
to generate and identify proteins as therapeutic targets in
the areas of pancreatic and lung cancer. Celera Genomics also
intends to initiate a proteomics program for an additional
disease during the 2003 fiscal year.
Celera Genomics plans to evaluate differential protein
patterns in biological samples from both healthy and diseased
individuals. Celera Genomics expects to evaluate sera samples,
which are readily available, as well as tissue samples, which
are less readily available. Celera Genomics has designed
advanced methods to separate cellular and subcellular
components of biological samples and to capture from these
components proteins belonging to druggable target classes.
Druggable target classes are related proteins which in the
past have been successfully used in the pharmaceutical
industry as points of therapeutic intervention. Celera
Genomics intends to use advanced chromatography and mass
spectrometer systems that are amenable to high throughput
quantitation and identification of proteins. Celera Genomics
expects to use its assembled human and mouse genomes and
proprietary software and algorithms to identify proteins
associated with diseases.
Celera Genomics expects to use a variety of methodologies to
validate targets and markers. Validation refers to the process
whereby the biological relevance of a particular target or
marker, and, therefore, its potential therapeutic or
diagnostic relevance, is confirmed. Celera Genomics intends to
use immunohistochemistry, or the identification of proteins in
tissues and cells using antibody reagents, to refine its
understanding of therapeutic targets and diagnostic markers of
interest and, for example, to identify expression profiles
that would support or preclude meaningful progression of the
drug targets. For targets and markers of interest, Celera
Genomics intends to perform tests to determine their relevance
across a broad range of tissues and diseases. Celera Genomics
has obtained and expects to continue accessing further
validation capabilities through collaborations. For example,
in 2001, Celera Genomics entered into a collaboration with
SomaLogic, Inc. to access its aptamer technology, which is
used to identify protein expression and function.
o Bioinformatics. Celera Genomics believes that its
bioinformatics infrastructure will accelerate the discovery
process of identifying targets and markers. For example,
Celera Genomics expects to develop the capability to perform
simulated, computer-based experimentation, which Celera
Genomics believes would minimize or eliminate the need to
perform more labor intensive experiments in the laboratory.
Also, Celera Genomics believes that it can develop proprietary
algorithms for use in its large scale computing infrastructure
for the extraction of data from proteomics experiments and the
integration of this data with genome, gene expression, and
protein characterization information, scientific literature,
and the patent status of possible targets or markers. Celera
Genomics believes the application of these algorithms to this
data could be used to facilitate the identification of targets
and markers. However, Celera Genomics' ability to develop
these capabilities is unproven, and, if developed, their
utility in the therapeutics discovery and development process
is uncertain.
-21-
o Genomics. As a complementary approach to the proteomics
methods described above, Celera Genomics expects to use
genomics to identify therapeutic targets. Celera Genomics
intends to further characterize novel genes, including those
for which the Company has been granted patents or for which it
has filed patent applications, by conducting in vitro cell
studies and in vivo animal studies. In vitro refers to testing
or other activities performed outside the living body, and in
vivo refers to testing or other activities performed in the
living body. Celera Genomics expects to incorporate its
bioinformatics capabilities into this process. After the
functions of genes are determined, Celera Genomics intends to
establish the priorities of these genes or their gene products
as targets based on the families of proteins they encode, the
association of the expression of these genes with specific
diseases, and the functional importance of the genes products
to cells. In 2001, Celera Genomics entered into a
collaboration with Isis Pharmaceuticals, Inc. to add to its
capabilities in this area. The collaboration provides Celera
Genomics with access to Isis Pharmaceuticals' antisense
technology, which is used to characterize the function of
selected genes.
Although Celera Genomics intends to use scientific methods that may
result in diagnostic discoveries, Celera Genomics has not yet determined how it
would seek to commercialize those discoveries, if any. They could be
commercialized through Celera Diagnostics or through other arrangements.
Axys Acquisition. In November 2001, Celera Genomics completed the
acquisition of Axys, a small molecule drug discovery and development company.
Celera Genomics believes that Axys' medicinal and structural chemistry and
biology capabilities and preclinical programs will accelerate the development of
its therapeutic discovery business for the following reasons:
o Axys' medicinal chemistry and biology capabilities are
expected to provide additional capabilities for in vivo and in
vitro target validation, as well as chemistry based validation
through hit-based functionation, which is the identification
of function through interaction with molecules of known
biological activity.
o Celera Genomics expects to benefit from Axys' expertise in the
fields of small molecule structure based drug design,
medicinal and combinatorial chemistry, and pharmacokinetic and
safety evaluation. Axys has developed a general expertise in
proteases, a known druggable class of proteins. Proteases are
enzymes that break down certain chemical bonds in proteins and
are essential to the body's physiological processes such as
inflammation. Proteases are generally classified by how they
break down a protein's chemical bonds. Cysteine and serine
proteases are two classes of these enzymes.
o Axys has existing drug discovery partnerships in the area of
inflammatory diseases, including (1) a collaboration with
Merck & Co. to develop small molecule inhibitors of cathepsin
K, a cysteine protease, for the treatment of osteoporosis, (2)
a collaboration with Aventis Pharmaceuticals to develop
inhibitors of cathepsin S, another type of cysteine protease,
for the treatment of rheumatoid arthritis, chronic obstructive
pulmonary disease, atherosclerosis, allergic rhinitis, and
asthma, and (3) a collaboration with Bayer AG to develop
inhibitors of tryptase, a serine protease, for the treatment
of asthma.
-22-
o Axys also has non-partnered preclinical programs, including a
program to develop inhibitors of Factor VIIa, a serine
protease, for the treatment of deep vein thrombosis and
cathepsin F, a cysteine protease, for the treatment of asthma
and other inflammatory diseases.
Scientific Progress Relating to Sequencing Efforts. In June 2000,
Celera Genomics and the Human Genome Project each announced the "first assembly"
of the human genome, and in April 2001, Celera Genomics announced the assembly
of the mouse genome. Assembly is the process by which individual fragments of
DNA, the molecule that forms the basis of the genetic material in virtually all
living organisms, are pieced together into their appropriate order and placed or
positioned on each chromosome within the genome. Celera Genomics' first assembly
of the human genome covered approximately 95% of that genome, and its assembly
of the mouse genome covered approximately 99% of that genome. Celera Genomics
released a detailed ordered consensus human genome assembly in the journal
Science in February 2001. Celera Genomics intends to continue updating the
assembly of the human and mouse genomes as it continues to annotate these
genomes, and to incorporate this information into its Celera Discovery System
database. Annotation is the process of assigning features or characteristics to
each chromosome. Each gene on each chromosome is given a name, its structural
features are described, and proteins encoded by genes are classified into
possible or known function.
In sequencing and assembling the human and mouse genomes, Celera
Genomics used an advanced strategy known as "shotgun sequencing." This technique
uses a combination of Applied Biosystems' high throughput sequencing equipment
to sequence DNA fragments and powerful computers and proprietary software
algorithms to assemble them. Celera Genomics believes that its shotgun
sequencing strategy has accelerated the generation of genomic information and
the discovery of new genes. This information includes rarely expressed genes,
predicted proteins, and other factors, such as regulatory regions, that control
gene expression. This data forms the basis of Celera Genomics' human genome
database. Information from this database is available through the Celera
Discovery System, which is currently being marketed by the Applied Biosystems
Knowledge Business.
As part of the Applera Genomics Initiative, Celera Genomics has
prioritized and is resequencing approximately 25,000 genes from 39 individuals
and a chimpanzee, which the Company believes will reveal a larger number of SNPs
with health related implications than are currently available. SNPs are
naturally occurring genetic variations within a genome that scientists believe
can be correlated with susceptibility to disease, disease prognosis, therapeutic
efficiency, and therapeutic toxicity. Celera Genomics has identified over
100,000 SNPs to date, a majority of which Celera Genomics believes have not been
previously identified by other researchers. Celera Genomics intends to use this
SNP data in its internal discovery efforts to improve the prediction of the
efficacy and toxicity of drug candidates.
Online Marketing and Distribution Agreement with Applied Biosystems;
Celera Discovery System. In April 2002, Celera Genomics and Applied Biosystems
entered into a marketing and distribution agreement pursuant to which Applied
Biosystems has become the exclusive marketer of Celera Genomics' Celera
Discovery System and related information assets. Applied Biosystems is expected
to integrate the Celera Discovery System and other genomic and biological
information into its new Knowledge Business. The agreement is expected to enable
Celera Genomics' executive team to focus on therapeutics discovery and
development.
-23-
In exchange for marketing and distribution rights to the Celera
Discovery System and other genomic and biological information and access to the
Celera Discovery System and related information, Applied Biosystems will provide
Celera Genomics with royalty payments on revenues generated by sales of certain
products of the Knowledge Business from July 1, 2002, through the end of fiscal
2012. The royalty rate is progressive, up to a maximum of 5%, with the level of
sales through fiscal 2008. The royalty rate becomes a fixed percentage of sales
starting in fiscal 2009, and the rate declines each succeeding fiscal year
through fiscal 2012. Assays-on-Demand, Assays-by-Design, certain reagents for
arrays, and new database subscriptions sold by the Knowledge Business are the
products subject to royalties.
Whether Celera Genomics actually receives any royalties from Applied
Biosystems under this agreement, and the amount of these royalties, depends on
Applied Biosystems' ability to successfully commercialize Knowledge Business
products subject to the royalty. The Knowledge Business is an emerging business,
and Applied Biosystems has not proven its ability to successfully commercialize
these products. Celera Genomics believes that in order for the Knowledge
Business to be successful, Applied Biosystems may have to devote significant
resources to researching, developing, marketing, and distributing Knowledge
Business products and services. However, Celera Genomics has no control over the
amount and timing of Applied Biosystems' use of its resources, including for
products subject to Celera Genomics' royalty. In addition, the market for these
products is intensely competitive, and there can be no assurance that there will
be market acceptance of the utility and value of the product offerings of the
Knowledge Business.
Under the terms of the marketing and distribution agreement, Celera
Genomics will receive all revenues under, and be responsible for all costs and
expenses associated with, Celera Discovery System and related information
contracts that were in effect on April 1, 2002, the effective date of the
agreement, or which were entered into during a three-month transition period
ended June 30, 2002 (as well as renewals of these contracts, if any). The
revenue anticipated by Celera Genomics under these contracts could be adversely
impacted as a result of changes made to Celera Discovery System products by or
at the request of Applied Biosystems pursuant to the marketing and distribution
agreement. However, Applied Biosystems has agreed to reimburse Celera Genomics
for any shortfall in earnings before interest, taxes, depreciation, and
amortization from these contracts below $62.5 million (as well as renewals, if
any) during the four fiscal years ending with the 2006 fiscal year if the
shortfall is due to changes made to Celera Discovery System products by or at
the request of Applied Biosystems, provided Celera Genomics otherwise continues
to perform under these contracts. During the term of the marketing and
distribution agreement (other than the transition period), Celera Genomics will
not be marketing Celera Discovery System products and services to, and will not
be contracting with, new customers. Accordingly, except for the anticipated
revenue under Celera Discovery System contracts in effect on June 30, 2002 and
renewals of these contracts, if any, and Applied Biosystems' corresponding
reimbursement obligation, Celera Genomics does not expect any revenues from
Celera Discovery System and related products and services other than the
potential royalty payments from Applied Biosystems under the marketing and
distribution agreement. Although under certain contracts with existing Celera
Discovery System customers, Celera Genomics is entitled to milestone payments or
future royalties based on products developed by its customers, Celera Genomics
believes these arrangements are unlikely to produce any significant revenue for
the group.
-24-
Celera Genomics will continue to have access to all data, which may
include formats not available to third parties, and other intellectual property
associated with the Celera Discovery System for its therapeutic programs. Celera
Genomics expects that such data and intellectual property will have a
significant role in its product research and development.
Raw Materials. Celera Genomics' operations require a variety of raw
materials, such as chemical and biochemical materials and other supplies, some
of which are occasionally found to be in short supply. Any interruption in the
availability of these materials could adversely affect Celera Genomics'
operations.
In particular, Celera Genomics needs access to human and other tissue
samples from diseased and healthy individuals, other biological materials, and
related clinical and other information, which may be in limited supply. Celera
Genomics may not be able to obtain or maintain access to these materials and
information on acceptable terms. In addition, government regulation in the
United States and foreign countries could result in restricted access to, or use
of, human and other tissue samples. If Celera Genomics loses access to
sufficient numbers or sources of tissue samples, or if tighter restrictions are
imposed on its use of the information generated from tissue samples, its
business may be harmed.
Patents, Licenses, Franchises and other Intellectual Property. Through
its internal research programs and collaborative programs, Celera Genomics
anticipates that it will develop an increasing portfolio of intellectual
property. Celera Genomics may use this intellectual property in its internal
development programs or may license such intellectual property to third party
collaborators or customers for some combination of license fees, milestone
payments, and royalty payments.
Celera Genomics' business and competitive position are dependent, in
part, on its ability to protect its database information, its software
technology, its novel DNA sequence discoveries, its SNP discoveries, its protein
discoveries, its therapeutic discoveries, and its diagnostic discoveries using a
variety of intellectual property mechanisms. In addition to seeking patent
protection, Celera Genomics may rely on copyright and trade secret laws to
protect its discoveries. Celera Genomics recognizes that many of the
intellectual property laws are directly suitable for application to such
discoveries while other protections may not be available or extend to cover
genomic and/or proteomic-based discoveries.
Celera Genomics has sought and expects to continue seeking patent
protection for inventions relating to its DNA sequence, SNP, protein,
therapeutic, and diagnostic discoveries. Celera Genomics' current plan is to
apply for patent protection for novel DNA sequences, SNPs, proteins, and novel
uses for these DNA sequences, SNPs and proteins, as well as therapeutic and
diagnostic agents it discovers or develops. Although obtaining patent protection
based on DNA sequences, SNPs, and proteins might enhance Celera Genomics'
business, Celera Genomics does not believe that its commercial success will be
materially dependent on its ability to do so. However, Celera Genomics' failure
to receive patents for its therapeutic and diagnostic discoveries could
adversely affect the commercial value of such discoveries. Currently, Celera
Genomics has patent applications claiming its DNA sequence, SNP, protein,
therapeutic, and diagnostic discoveries that are pending in the United States
and in foreign jurisdictions and currently owns 55 United States patents.
The issuance of patents is uncertain worldwide. Furthermore, laws
relating to the patenting of novel DNA sequences and proteins are currently
under review and revision in many
-25-
countries. Moreover, publication of information concerning partial DNA sequences
prior to the time that Celera Genomics applies for patent protection may affect
Celera Genomics' ability to obtain patent protection. In addition, patent claims
to a partial sequence may not cover a full-length sequence inclusive of that
partial sequence. Currently, the United States Patent and Trademark Office
requires disclosure in the patent application of a specific and substantial and
credible utility in order to support the patentability of a DNA sequence or
protein.
In January 1997, TIGR, in collaboration with the National Center for
Biological Information, disclosed full-length DNA sequences assembled from
expressed sequence tags available in publicly accessible databases or sequenced
at TIGR. The National Human Genome Research Institute also plans to release
sequence information to the public. These disclosures might limit the scope of
Celera Genomics' claims or make subsequent discoveries related to certain DNA
sequences and proteins unpatentable. While Celera Genomics believes that the
publication of sequence data will not preclude it or others in all instances
from obtaining patent protection on certain DNA sequences and proteins, there
can be no assurances that these publications will not affect the ability to
obtain patent protection.
In February 2001, Celera Genomics disclosed an assembly of the human
genome and gene/protein annotations in a publicly accessible database at Celera
Genomics. The federally funded Human Genome Project also released a human genome
sequence assembly to the public on this date, and has announced that a finished
version of its human genome sequence will be completed in 2003. These
disclosures might limit the scope of Celera Genomics' claims or make subsequent
discoveries related to certain DNA sequences and proteins unpatentable. While
Celera Genomics believes that the publication of sequence data will not preclude
it or others in all instances from obtaining patent protection on certain DNA
sequences and proteins, there can be no assurances that these publications will
not affect the ability to obtain patent protection.
Celera Genomics also cannot ensure that any changes to, or
interpretations of, the patent laws will not adversely affect its patent
position. Celera Genomics anticipates that there may be significant litigation
regarding genomic patent and other intellectual property rights. If Celera
Genomics becomes involved in such litigation, it could consume a substantial
portion of Celera Genomics' resources, and Celera Genomics may not ultimately
prevail. If Celera Genomics does not prevail in a patent litigation dispute, it
may be required to pay damages or royalties or to take measures to avoid any
future infringement, or Celera Genomics may not be able to stop a competitor
from making, using, or selling similar products or technology.
Celera Genomics also intends to rely on trade secret protection for its
confidential and proprietary information. Celera Genomics believes it has
developed proprietary procedures for sequencing and analyzing genes and for
assembling the genes in their naturally occurring order. In addition, Celera
Genomics believes it has developed novel methods for searching and identifying
particularly important regions of genetic information or whole genes of
interest. Celera Genomics currently protects these methods and procedures as
trade secrets and has sought patent protection for some of the proprietary
methods although no such patents have yet been issued.
Celera Genomics has sought and plans to continue seeking intellectual
property protection, including copyright protection, for the Celera Discovery
System, including its content, and the software and methods it creates to
manage, store, analyze, and search novel information. Celera Genomics has taken
security measures to protect its databases, including entering into
confidentiality agreements with employees and academic collaborators who are
-26-
provided or have access to confidential or proprietary information. Celera
Genomics continues to explore ways to further enhance the security for its data,
including copyright protection for its databases.
Backlog. Celera Genomics' total recorded backlog at June 30, 2001 was
$66.1 million. Celera Genomics' total recorded backlog at June 30, 2002 was
$81.5 million. It is Celera Genomics' general policy to include in backlog only
purchase orders that have firm delivery dates within one year. Recorded backlog
may not result in sales because of cancellation or other factors. It is
anticipated that all orders included in the current backlog will be delivered
before the close of fiscal year 2003.
Competition. The pharmaceutical industry is competitive and evolving.
There is intense competition among pharmaceutical and biotechnology companies
attempting to discover candidates for potential new therapeutic products. These
companies may:
o develop new therapeutic products in advance of Celera
Genomics;
o develop therapeutic products which are more effective or more
cost-effective than those developed by Celera Genomics;
o obtain regulatory approvals of their therapeutic products more
rapidly than Celera Genomics; or
o obtain patent protection or other intellectual property rights
that would limit Celera Genomics' ability to develop and
commercialize therapeutic products.
Research and Development. Celera Genomics is actively engaged in basic
and applied research and development programs designed to develop new
therapeutic products and support the commitments of existing online/information
contracts. Research and development expenses for Celera Genomics totaled $148.6
million in fiscal 2000, $164.7 million in fiscal 2001, and $132.7 million in
fiscal 2002. The Company expensed $255.6 million in fiscal 2000, $323.4 million
in fiscal 2001, and $381.9 million in fiscal 2002 for Company-sponsored
research, development, and engineering activities.
Celera Genomics' new products are expected to originate from three
sources: internal research and development programs, external collaborative
efforts or alliances, and business and technology acquisitions.
Environmental Matters. Celera Genomics is subject to federal, state,
and local laws and regulations regulating the discharge of materials into the
environment, or otherwise relating to the protection of the environment, in
those jurisdictions where Celera Genomics operates or maintains facilities.
Celera Genomics does not believe that any liability arising under, or compliance
with, environmental laws or regulations will have a material effect on its
business, and no material capital expenditures are expected for environmental
control.
Celera Diagnostics, a Joint Venture between Applied Biosystems and
Celera Genomics
Overview. Celera Diagnostics is engaged principally in the discovery,
development, and commercialization of novel human diagnostic products. These
products are expected to provide genetic information which may lead to earlier
and more effective treatment of disease. Celera
-27-
Diagnostics expects that the primary users of its products will be reference
laboratories, hospitals, and medical clinics worldwide that perform diagnostic
testing for human health care.
During the 2001 fiscal year, Celera Diagnostics was formed and moved
into its principal facilities in Alameda, California. During the 2002 fiscal
year, its first full fiscal year of operations, it took a number of steps,
including the following, to develop its business:
o it assembled an experienced management team;
o it integrated the pre-existing molecular diagnostics business
contributed by Applied Biosystems in connection with the
formation of Celera Diagnostics;
o it substantially increased its staff in the area of discovery
research, product development, manufacturing, quality,
regulatory affairs, and marketing;
o it completed construction of its high-volume discovery
laboratories for conducting genotyping and gene expression
research;
o it initiated its first gene-disease association study, which
is being conducted to identify genetic markers that correlate
with Alzheimer's disease;
o it entered into a strategic alliance with Abbott Laboratories
to develop, manufacture, and market a broad range of in vitro
molecular diagnostic products, or molecular diagnostic
products that are used for testing outside of the living body,
for disease detection, disease progression monitoring, and
therapy selection; and
o it submitted its first regulatory filing to the United States
Food and Drug Administration for an HIV diagnostic product.
Summary of Joint Venture Agreement. Celera Diagnostics was formed
during the 2001 fiscal year as a joint venture between Applied Biosystems and
Celera Genomics. In connection with the formation of Celera Diagnostics, Applied
Biosystems contributed, among other things, its then-existing molecular
diagnostics business to Celera Diagnostics, and Celera Genomics contributed,
among other things, access to its genome databases. Also, Celera Genomics agreed
to fund all of the cash operating losses of Celera Diagnostics up to a maximum
of $300 million ("initial losses"), after which, operating losses, if any, will
be shared equally by Applied Biosystems and Celera Genomics. Celera Diagnostics'
profits, if any, will be shared in the ratio of 65 percent to Celera Genomics
and 35 percent to Applied Biosystems until the cumulative profits of Celera
Diagnostics equal the initial losses. Subsequently, profits and losses and cash
flows would be shared equally between the groups. Capital expenditures and
working capital requirements of Celera Diagnostics will be funded equally by the
groups. Applied Biosystems will reimburse Celera Genomics for all tax benefits
generated by Celera Diagnostics to the extent such tax benefits are utilized by
Applied Biosystems. In the event of liquidation of the assets attributable to
Celera Diagnostics, including sale of these assets, the proceeds upon
liquidation would be distributed to Applied Biosystems and Celera Genomics based
on a proportion similar to their relative investment accounts. If the proceeds
upon liquidation are in excess of the groups' combined investment accounts, the
excess liquidation proceeds would be shared in the ratio of 65 percent to Celera
Genomics and 35 percent to Applied Biosystems until the cumulative amount of the
distributed excess proceeds equals the initial losses funded by Celera
-28-
Genomics. Any additional liquidation proceeds would be allocated equally to
Celera Genomics and Applied Biosystems.
Research and Development; Abbott Laboratories Strategic Alliance.
During the 2002 fiscal year, Celera Diagnostics first focused its activities on
staffing and completing its high-volume discovery laboratories, and then began
research and development of products that detect infectious diseases and human
genetic disorders. Celera Diagnostics expects to expand these research and
development efforts, and in particular, it intends to leverage its genotyping
and gene expression capabilities, and the SNP data from the Applera Genomics
Initiative, to perform large-scale gene-disease association studies to identify
new diagnostic markers. Celera Diagnostics' first gene-disease association
study, involving Alzheimer's disease, is currently underway, and several
additional studies in cancer, cardiovascular disease, and inflammatory diseases
are planned for the current fiscal year. If these studies are successful, Celera
Diagnostics expects to develop and market reagents that detect the newly
discovered genetic markers.
In June 2002, Celera Diagnostics announced a strategic alliance with
Abbott Laboratories, one of the world's largest diagnostics companies, to
discover, develop and commercialize a broad range of in vitro diagnostic
products for disease detection, disease progression monitoring, and therapy
selection. The agreement with Abbott Laboratories is limited to diagnostic
products that detect nucleic acids, for example DNA or RNA. Diagnostics based on
the detection of proteins, rather than nucleic acids, is another potential
business area for Celera Diagnostics but is not a part of the agreement with
Abbott Laboratories and is not a current focus of Celera Diagnostics. Under the
Abbott Laboratories agreement, Celera Diagnostics and Abbott Laboratories will
jointly fund research and development. Celera Diagnostics believes that Abbott
Laboratories' expertise in the diagnostics industry will enhance Celera
Diagnostics' research and development efforts, and expedite its ability to bring
products to market.
Celera Diagnostics expects to rely substantially on its alliance with
Abbott Laboratories for the success of its business strategy for the foreseeable
future. The Abbott Laboratories agreement may be terminated by a non-breaching
party in the event of a material breach and, under certain circumstances, by
either party in the event of a change in control of the other party. Also,
Celera Diagnostics cannot ensure that Abbott Laboratories will perform its
obligations as expected. If Abbott Laboratories terminates the alliance or
otherwise fails to conduct its collaborative activities in a timely manner, the
development or commercialization of diagnostics products may be delayed or
otherwise adversely affected.
Research and development expenses for Celera Diagnostics totaled $4.5
million in fiscal 2001 and $39.0 million in fiscal 2002. The Company expensed
$255.6 million in fiscal 2000, $323.4 million in fiscal 2001, and $381.9 million
in fiscal 2002 for Company-sponsored research, development, and engineering
activities.
Celera Diagnostics Products. Celera Diagnostics plans to develop
products that provide useful genetic information to facilitate disease
detection, prediction of disease predisposition, disease progression, disease
severity, and responsiveness to treatment regimens. Such products are expected
to include primarily in vitro diagnostic test kits, which may be labeled for use
in diagnosing specific diseases or other conditions, as well as products
referred to as "analyte specific reagents," which may be used for clinical
testing but which may not be labeled for use in diagnosing any specific disease
or condition.
-29-
While the sale of in vitro diagnostic test kits requires clearance or
approval by the United States Food and Drug Administration, analyte specific
reagents are a class of products defined by the agency's regulations which may
be sold without any regulatory submission, so long as they are manufactured and
marketed in compliance with the requirements of the agency's Quality System
regulations, such as Good Manufacturing Practices. Because analyte specific
reagents are not subject to United States Food and Drug Administration clearance
or approval, Celera Diagnostics believes they can generally be commercialized
sooner than diagnostic test kits, though the labeling restrictions would likely
affect market acceptance of the products.
Celera Diagnostics is currently marketing three products, all of which
were contributed by Applied Biosystems in connection with the formation of
Celera Diagnostics in different stages of development. Following is a
description of these products:
o ViroSeq(TM) HIV-1 Genotyping System. The genome of human
immunodeficiency virus, commonly known as HIV, undergoes
mutations in an infected patient, especially in response to
anti-viral drug treatment. Some of the mutations have been
shown to render the virus resistant to the action of these
drugs, thereby diminishing the effectiveness of the treatment.
Therefore, the detection of mutations in HIV that correlate
with drug resistance provides useful information to physicians
in monitoring the course of treatment and selecting the most
effective regimen for each individual HIV-infected patient.
During the 2002 fiscal year, Celera Diagnostics submitted a
510(k) filing to the United States Food and Drug
Administration for the ViroSeq(TM) HIV-1 Genotyping System. A
510(k) filing is a pre-market notification to the United
States Food and Drug Administration that Celera Diagnostics
intends to market this product as an in vitro diagnostic test
kit. This product is for use in testing human blood samples
for identifying drug-resistant mutations in the HIV-1 genome.
HIV-1 is one of the most prevalent strains of HIV. Celera
Diagnostics' filing is currently under review by the agency,
which must provide clearance before Celera Diagnostics can
market the product in the United States. Regulatory approval
was granted in France for this product during the 2002 fiscal
year, and the product is currently being marketed in that
country.
o Cystic Fibrosis Assay. Cystic fibrosis is an inherited genetic
disorder that affects children and young adults. It is caused
by a number of mutations in the cystic fibrosis gene.
Detection of these mutations should allow for testing of women
during pregnancy, as currently recommended by the American
College of Obstetricians and Gynecologists, as well as for
early monitoring of the disease and prescription of
appropriate treatment. Celera Diagnostics sells analyte
specific reagents that identify mutations in the cystic
fibrosis gene.
o HLA Sequencing-Based Typing Kits. Transplantation of tissues
and organs between genetically-unrelated individuals usually
results in rejection of the donor graft, or tissue, by the
recipient. Such rejection is due to differences in certain
genes between a donor and a recipient. These genes have been
mapped to a region of the human genome known as HLA. Analysis
of HLA genes to match donor-recipient pairs with minimal
differences in these genes has greatly improved the success of
transplantation. Celera Diagnostics' HLA-typing products
detect specific DNA
-30-
sequences in several HLA genes that are known to be involved
in transplantation rejection, and thus provide useful
information regarding the likelihood of transplant rejection
by a recipient. Celera Diagnostics has not sought or received
clearance or approval of the United States Food and Drug
Administration for these products, and does not manufacture
these products in accordance with United States Food and Drug
Administration requirements. Accordingly, these products can
be sold only for research use and cannot be sold for
diagnostic purposes either as diagnostic kits or as analyte
specific reagents. Celera Diagnostics is evaluating its
strategy for these products, which may result in
discontinuance or which may result in further development to
enable sale as diagnostic products.
Regulation of Diagnostic Products. In the United States and in other
countries, diagnostic products are heavily regulated by governmental agencies.
Although some of the products that Celera Diagnostics expects to market may not
require regulatory clearance or approval, its current business strategy is to
develop and market a number of products that will require this clearance or
approval, including for example its ViroSeq HIV-1 Genotyping System. In the
United States, either Celera Diagnostics or its collaborators will have to show
through pre-clinical studies and clinical trials that each of these diagnostic
product candidates is safe and effective for each indication before obtaining
regulatory clearance or approval from the United States Food and Drug
Administration for the commercial sale of that product. Outside of the United
States, the regulatory requirements vary from country to country. If Celera
Diagnostics or its collaborator fails to adequately show the safety and
effectiveness of a diagnostic product, regulatory clearance or approval could be
delayed or denied. The results from pre-clinical studies may be different from
the results that are obtained in large-scale clinical trials. Celera Diagnostics
cannot be certain that it will show sufficient safety and effectiveness in its
clinical trials to allow it to obtain the needed regulatory clearance or
approval. The regulatory review and approval process can take many years and
require substantial expense and may not be successful. A number of companies in
the diagnostics industry, including biotechnology companies, have suffered
significant setbacks in advanced clinical trials, even after promising results
in earlier studies.
Even if Celera Diagnostics obtains regulatory clearance or approval, it
will be subject to certain risks and uncertainties relating to regulatory
compliance, including: post-approval clinical studies and inability to meet the
compliance requirements of the United States Food and Drug Administration's Good
Manufacturing Practices (Quality System) regulations. In addition, the
occurrence of manufacturing problems could cause subsequent suspension of
product manufacture or withdrawal of approval, or could require reformulation of
a diagnostic product, additional testing, or changes in labeling of the product.
This could delay or prevent Celera Diagnostics from generating revenues from the
sale of that diagnostic product.
Marketing and Distribution. Celera Diagnostics expects that reference
laboratories, hospitals, and medical clinics that perform diagnostic testing
will be the primary users of its products. Celera Diagnostics does not expect to
develop its own marketing and distribution organization for the foreseeable
future. Under the terms of its strategic alliance with Abbott Laboratories,
Abbott Laboratories will serve as Celera Diagnostics' exclusive worldwide
distributor of nucleic acid-based diagnostic products developed under the
agreement.
Celera Diagnostics expects that substantially all of its nucleic acid
testing products for the foreseeable future will be covered by the Abbott
Laboratories agreement. However, in the future Celera Diagnostics may develop
products not covered by the agreement, in which case
-31-
Celera Diagnostics would have to develop its own marketing and distribution
capability or find other distributors for these products.
Raw Materials. Celera Diagnostics' operations require a variety of raw
materials, such as chemical and biochemical materials, and other supplies, some
of which are occasionally found to be in short supply. Any interruption in the
availability of these materials could adversely affect Celera Diagnostics'
operations.
In particular, Celera Diagnostics needs access to human tissue samples
from diseased and healthy individuals, other biological materials, and related
clinical and other information, which may be in limited supply. Celera
Diagnostics may not be able to obtain or maintain access to these materials and
information on acceptable terms. In addition, government regulation in the
United States and foreign countries could result in restricted access to, or use
of, human tissue samples. If Celera Diagnostics loses access to sufficient
numbers or sources of tissue samples, or if tighter restrictions are imposed on
its use of the information generated from tissue samples, its business may be
harmed.
Patents, Licenses, and Franchises. Through its internal research
programs and collaborative programs, including the Applera Genomics Initiative,
Celera Diagnostics anticipates that it will develop an increasing portfolio of
intellectual property. Celera Diagnostics may use such intellectual property in
its internal development programs or may license it to third parties or
customers for some combination of license fees, milestone payments, and royalty
payments.
Celera Diagnostics' products are based on complex, rapidly developing
technologies. Some of these technologies are covered by patents owned by Applied
Biosystems and Celera Genomics, and other patents are owned by third parties and
used by Celera Diagnostics under license.
Competition. The diagnostic industry in which Celera Diagnostics
operates is competitive and evolving. There is intense competition among
healthcare, biotechnology, and diagnostic companies attempting to discover
candidates for potential new diagnostic products. These companies may:
o develop new diagnostic products in advance of Celera
Diagnostics;
o develop diagnostic products which are more effective or more
cost-effective than those developed by Celera Diagnostics;
o obtain regulatory clearance or approval of their diagnostic
products more rapidly than Celera Diagnostics; or
o obtain patent protection or other intellectual property rights
that would limit Celera Diagnostics' ability to develop and
commercialize, or its customers' ability to use, Celera
Diagnostics' diagnostic products.
Celera Diagnostics competes with entities in the United States and
abroad that are engaged in the development and commercialization of products
that provide genetic information. They include:
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o purveyors of genetic testing services, which are not subject
to the same clinical validation requirements as Celera
Diagnostics' products, and which do not require United States
Food and Drug Administration or other regulatory approval,
including Laboratory Corporation of America Holdings, Quest
Diagnostics Inc., and Specialty Laboratories, Inc.;
o manufacturers of analyte specific reagents and genotyping test
kits;
o purveyors of phenotyping assay services, which are used to
determine the physical traits of diseased samples; and
o manufacturers and distributors of DNA probe-based diagnostic
systems.
Environmental Matters. Celera Diagnostics is subject to federal, state,
and local laws and regulations regulating the discharge of materials into the
environment, or otherwise relating to the protection of the environment, in
those jurisdictions where Celera Diagnostics operates or maintains facilities.
Celera Diagnostics does not believe that any liability arising under, or
compliance with, environmental laws or regulations will have a material effect
on its business, and no material capital expenditures are expected for
environmental control.
Employees
As of June 30, 2002, the Company had approximately 5,950 employees
allocated as follows:
Business/Function Number
----------------- ------
Applied Biosystems 4,790
Celera Genomics 820
Celera Diagnostics 160
Corporate Staff 180
The Company's corporate staff provides accounting, tax, treasury,
legal, information technology, human resources, and other internal services for
Applied Biosystems, Celera Genomics, and Celera Diagnostics. None of Applied
Biosystems' United States employees, and none of Celera Genomics' or Celera
Diagnostics' employees or the Company's corporate staff employees, are subject
to collective bargaining agreements. The Company generally considers its
relations with its employees to be good.
Financial Information About Geographic Areas
A summary of net revenues from external customers and long-lived assets
attributed to each of the Company's geographic areas for the fiscal years 2000,
2001, and 2002 is incorporated herein by reference to Note 14 on pages 71-83 of
the Company's Annual Report to Stockholders for the fiscal year ended June 30,
2002.
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The Company's consolidated net revenues from external customers in
countries other than the United States for fiscal years 2000, 2001, and 2002
were $690.0 million, $833.9 million, and $845.4 million, or 50.3%, 50.7%, and
49.7%, respectively, of the Company's consolidated net revenues.
The Company's manufacturing facilities outside the continental United
States are located in the United Kingdom, Japan, and Singapore.
Executive Officers of the Registrant
Information concerning the executive officers of the Company is
incorporated by reference to the description under the heading "Identification
and Business Experience of Executive Officers" on pages 71 and 72 in Part III of
this Annual Report on Form 10-K.
Item 2. PROPERTIES
Applied Biosystems Group Facilities
Applied Biosystems' headquarters are located in leased facilities in
Foster City, California. Applied Biosystems owns or leases various other
facilities worldwide for manufacturing, distribution, warehousing, research and
development, sales and demonstration, service, and administration. The following
is a list of Applied Biosystems' principal and other material facilities. Except
as otherwise noted below, substantially all of the space in these facilities is
used by Applied Biosystems and these facilities are maintained in good working
order.
Owned or Leased
Location (Approximate Floor Area in Sq. Ft.) (Expiration Date of Leases)
- -------------------------------------------- ---------------------------
Foster City, CA (762,000) Leased (2003-2015)
Hayward, CA (66,000) Leased (2004)
San Jose, CA (81,000) Owned
Bedford, MA (73,000) Leased (2004 - 2011)
Framingham, MA (140,000) Leased (2009)
Cambridge, MA (10,700) Leased (2003)
Santa Fe, NM (14,000) Leased (2010)
Houston, TX (50,000) Leased (2004)
Warrington, United Kingdom (88,000) Owned
Rotterdam, Netherlands (64,000) Leased (2010)
Singapore (36,000) Leased (2002)
Narita, Japan (24,000) Owned
The Foster City, California facilities are comprised of 27 buildings
located at a single complex. These buildings are leased from various parties
under leases that expire between 2003 and 2015. The Bedford, Massachusetts
facilities include 3 buildings at separate locations within that city having
approximately 30,000, 28,000, and 15,000 square feet, the leases for which
expire in 2011, 2004, and 2007. The Warrington, United Kingdom facilities
include 2 buildings at separate locations within that city having approximately
49,000 and 39,000 square feet.
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Applied Biosystems purchased an 80-acre property in Pleasanton,
California, in September 2000, on which the Company intends to construct new
facilities with approximately 600,000 square feet for research and development,
manufacturing, and administrative purposes. Since acquiring this property,
Applied Biosystems has demolished a majority of the existing facilities and
commenced the first phase of construction. During this first phase, Applied
Biosystems is constructing two buildings comprising approximately 140,000 and
95,000 square feet. Applied Biosystems expects to complete and occupy the
smaller of these two buildings during the first half of 2003. Completion and
occupancy of the other building is expected to occur later in 2003.
Also, Applied Biosystems is currently constructing a new building with
approximately 30,000 square feet in Bedford, Massachusetts. Applied Biosystems
expects to move its Cambridge, Massachusetts operations to this building upon
the expiration of the Cambridge, Massachusetts lease in March 2003.
Applied Biosystems also owns approximately 15 acres of undeveloped land
in Vacaville, California, and is evaluating whether to develop or sell this
property.
Celera Genomics Group Facilities
Celera Genomics' headquarters are located in two owned adjacent
buildings in Rockville, Maryland. Celera Genomics' administrative facilities,
sequencing facility, research and development laboratories, bioinformatics data
center, and proteomics laboratory are located at its headquarters. Celera
Genomics also leases various other facilities for research and development,
sales, and service, as well as a facility in Pasadena, California which is the
headquarters for Paracel, Inc., which was acquired by Celera Genomics in June
2000. The following is a list of Celera Genomics' principal and other material
facilities. Except as otherwise noted below, substantially all of the space in
these facilities is used by Celera Genomics and these facilities are maintained
in good working order:
Owned or Leased
Location (Approximate Floor Area in Sq. Ft.) (Expiration Date of Leases)
- -------------------------------------------- ---------------------------
Rockville, MD (220,000) Owned
Pasadena, CA (85,000) Leased (2011)
South San Francisco, CA (69,300) Leased (2006)
South San Francisco, CA (44,000) Owned
South San Francisco, CA (13,600) Leased (2006)
Celera Genomics expects to use approximately 80% of the capacity of the
owned facility in Rockville, Maryland for the foreseeable future. The Company
expects that the remaining approximately 20% of capacity will be used by Applied
Biosystems and for general corporate purposes. Also, this facility is located on
a parcel of land owned by the Company that includes approximately 13 acres of
undeveloped land. The Company believes this land could be used for the
construction of additional facilities, if necessary.
Celera Genomics expects to use approximately 35% of the capacity of the
leased facility in Pasadena, California for the remainder of the lease term. The
Company has subleased a
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portion of the remaining capacity and is seeking to sublease the balance of the
remaining capacity for the remainder of the lease term.
The owned facility in South San Francisco, California is located on
land leased by the Company under a long-term ground lease.
Celera Diagnostics Facilities
The Company has leased the following two facilities to serve as the
principal facilities for Celera Diagnostics, which Celera Diagnostics is using
as its headquarters as well as for research and development and administrative
purposes, and which it expects to use for manufacturing purposes in the future.
Except as otherwise noted below, these facilities are maintained in good working
order.
Owned or Leased
Location (Approximate Floor Area in Sq. Ft.) (Expiration Date of Leases)
- -------------------------------------------- ---------------------------
Alameda, CA (48,000) Leased (2006)
Alameda, CA (19,000) Leased (2006)
Celera Diagnostics is using substantially all of the space in these two
facilities except for approximately 10,000 square feet in the larger facility,
which Celera Diagnostics is renovating for use in manufacturing, and
approximately 8,000 square feet in the same facility, which Celera Diagnostics
is renovating for use as additional research and development space. Celera
Diagnostics expects to complete the renovations of, and occupy, the
manufacturing space by the end of 2002, and expects to complete the renovations
of, and occupy, the research and development space in early 2003. Pending
completion of these manufacturing facilities, Celera Diagnostics has been using
up to approximately 19,000 square feet of Applied Biosystems' space in Foster
City, California, for manufacturing.
Corporate Facilities
The Company's corporate headquarters is located in a leased facility in
Norwalk, Connecticut. The Company leases approximately 51,000 square feet at
this facility, substantially all of which the Company uses for corporate staff
and related support functions. This facility is maintained in good working
order.
The Company also owns another facility in Norwalk and Wilton,
Connecticut, with an area of approximately 402,000 square feet. This facility
was previously used for the Company's corporate headquarters, but is no longer
used by the Company. This facility is being held for sale or long term lease.
This facility is currently vacant and is expected to remain vacant pending
completion of such a sale or lease.
Item 3. LEGAL PROCEEDINGS
The Company is involved in various legal proceedings from time to time,
including actions with respect to commercial, intellectual property, antitrust,
environmental, securities, and employment matters. The following is a
description of certain claims currently being defended by the Company. The
Company believes that it has meritorious defenses against the claims
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currently asserted against it, including those described below, and intends to
defend them vigorously. However, the outcome of litigation is inherently
uncertain, and the Company cannot be sure that it will prevail in any of the
cases described below or in the Company's other current litigation. An adverse
determination in certain of the Company's current litigation, particularly the
cases described below under the headings "Securities Litigation," "MJ Research
Litigation," "Promega Litigation," and "Beckman Coulter Litigation," could have
a material adverse effect on the Company.
Securities Litigation
The Company and some of its officers were served in five lawsuits
between April and May 2000, purportedly on behalf of purchasers of Applera
Corporation - Celera Genomics Group Common Stock in the Company's follow-on
public offering of Applera Corporation - Celera Genomics Group Common Stock
completed on March 6, 2000. In the offering, the Company sold an aggregate of
approximately 4.4 million shares of Applera Corporation - Celera Genomics Group
Common Stock at a public offering price of $225 per share. All of these lawsuits
have been consolidated into a single case and are pending in the United States
District Court for the District of Connecticut, and an amended consolidated
complaint was filed on August 21, 2001. The consolidated complaint generally
alleges that the prospectus used in connection with the offering was inaccurate
or misleading because it failed to adequately disclose the alleged opposition of
the Human Genome Project and two of its supporters, the governments of the
United States and the United Kingdom, to providing patent protection to the
Company's genomic-based products. Although Celera Genomics has never sought, or
intended to seek, a patent on the basic human genome sequence data, the
complaint also alleges that the Company did not adequately disclose the risk
that it would not be able to patent this data. The consolidated complaint seeks
unspecified money damages, rescission, costs and expenses, and other relief as
the court deems proper. A motion to dismiss the case filed by the Company and
the other defendants is pending.
MJ Research Litigation
The Company is involved in several litigation matters with MJ Research,
Inc., commencing with the Company's filing claims against MJ Research based on
its alleged infringement of certain polymerase chain reaction, or PCR, patents.
On December 21, 2000, MJ Research filed an action against the Company in the
United States District Court for the District of Columbia. The complaint is
based on the allegation that the patents underlying the Company's DNA sequencing
instruments were invalidly obtained because one of the alleged inventors, whose
work was funded in part by the United States government, was knowingly omitted
from the patent applications. The Company patents at issue are U.S. Patent Nos.
5,171,534, 5,821,058, 6,200,748, and 4,811,218. The complaint asserts violations
of the Federal False Claims Act and the Federal Bayh Dole Act, invalidity and
unenforceability of the patents at issue, patent infringement, and various other
civil claims against the Company. MJ Research is seeking monetary damages, costs
and expenses, injunctive relief, transfer of ownership of the patents in
dispute, and other relief as the court deems proper. MJ Research claims to be
suing in the name of the United States government although the government has to
date declined to participate in the suit.
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Promega Litigation
On April 24, 2001, Promega Corporation filed a patent infringement
action against the Company, Lifecodes Corporation, Cellmark Diagnostics, and
Genomics International Corporation in the United States District Court for the
Western District of Wisconsin. The complaint alleges that the defendants are
infringing Promega's U.S. Patent Nos. 6,221,598 and 5,843,660, both entitled
"Multiplex Amplification of Short Tandem Repeat Loci," due to the defendants'
sale of forensic identification and paternity testing kits. Promega is seeking
monetary damages, costs and expenses, injunctive relief, and other relief as the
court deems proper. The defendants answered the complaint on July 9, 2001, and
the Company asserted counterclaims alleging that Promega is infringing the
Company's U.S. Patent No. 6,200,748, entitled "Tagged Extendable Primers and
Extension Products," due to Promega's sale of forensic identification and
paternity testing kits. The trial in this case is currently scheduled for
November 18, 2002.
Beckman Coulter Litigation
On July 3, 2002, Beckman Coulter, Inc., filed a patent infringement
action against the Company in the United States District Court for the Central
District of California. The complaint alleges that the Company is infringing
Beckman Coulter's U.S. Patent Nos. RE 37,606 and 5,421,980, both entitled
"Capillary Electrophoresis Using Replaceable Gels," and U.S. Patent No.
5,552,580, entitled "Heated Cover Device," although it does not identify the
specific facts on which this allegation is based. Beckman Coulter is seeking
monetary damages, costs and expenses, injunctive relief, and other relief as the
court deems proper.
United States v. Davis
The Company is a party to the action United States v. Davis, pending in
the United States District Court for the District of Rhode Island. The Company
was brought into the case along with numerous other companies as a result of a
third party complaint filed by United Technologies Corporation ("UTC") seeking
contribution for environmental cleanup costs imposed by the United States
government. In December 1998, the District Court found the Company liable to UTC
along with certain, but not all, of the defendants in the case. The Company
believes the amount of such liability to be less than $200,000, which will be
determined when all appeals have been concluded. Both UTC and the Company
appealed the District Court's decision. In August 2001, the United States Court
of Appeals for the First Circuit affirmed the District Court's decision and
remanded the case to the District Court for further proceedings. The Company and
the other defendants are considering the decision of the Court of Appeals and
their legal alternatives.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not applicable.
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PART II
Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY
AND RELATED STOCKHOLDER MATTERS
Market Information
The principal United States market where the Company's Applera
Corporation - Applied Biosystems Group Common Stock and Applera Corporation -
Celera Genomics Group Common Stock are traded is the New York Stock Exchange,
although such stock is also traded on the Pacific Exchange.
Applera Corporation - Applied Biosystems Group Common Stock is listed
on the New York Stock Exchange under the trading symbol "ABI" and is intended to
reflect the relative performance of Applied Biosystems. Applera Corporation -
Celera Genomics Group Common Stock is listed on the New York Stock Exchange
under the trading symbol "CRA" and is intended to reflect the relative
performance of Celera Genomics. There is no single security that represents the
performance of the Company as a whole, nor is there a separate security traded
for Celera Diagnostics.
Holders of Applera Corporation - Applied Biosystems Group Common Stock
and Applera Corporation - Celera Genomics Group Common Stock are stockholders of
the Company. Applied Biosystems and Celera Genomics are not separate legal
entities, and holders of these stocks are stockholders of a single company, the
Company. As a result, holders of these stocks are subject to all of the risks
associated with an investment in the Company and all of its businesses, assets,
and liabilities.
The high and low sales prices of Applera Corporation - Applied
Biosystems Group Common Stock and Applera Corporation - Celera Genomics Group
Common Stock for each quarterly period during fiscal years 2001 and 2002 is
incorporated herein by reference to Note 11, page 69, of the Company's Annual
Report to Stockholders for the fiscal year ended June 30, 2002.
Holders
On September 4, 2002, the approximate number of holders of Applera
Corporation - Applied Biosystems Group Common Stock was 6,244, and the
approximate number of holders of Applera Corporation - Celera Genomics Group
Common Stock was 6,535. The approximate number of holders is based upon the
actual number of holders registered in the Company's records at such date and
does not include holders of shares in "street name" or persons, partnerships,
associations, corporations, or other entities identified in security position
listings maintained by depository trust companies. The calculation of the market
value of shares held by non-affiliates shown on the cover of this Annual Report
on Form 10-K was made on the assumption that there were no affiliates other than
executive officers and directors as of the date of calculation.
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Dividends
Information regarding the amount of quarterly dividends during fiscal
years 2001 and 2002 is incorporated herein by reference to Note 11, page 69, of
the Company's Annual Report to Stockholders for the fiscal year ended June 30,
2002.
Sale of Unregistered Securities
The Company has not sold any securities during the fiscal year ended
June 30, 2002, that were not registered under the Securities Act of 1933.
Forward Looking Statements and Risk Factors
Certain statements contained in, or incorporated by reference in, this
Annual Report on Form 10-K are forward-looking and are subject to a variety of
risks and uncertainties. These statements may be identified by the use of
forward-looking words or phrases such as "believe," "expect," "intend,"
"anticipate," "should," "plan," "estimate," and "potential," among others. These
forward-looking statements are based on the Company's current expectations. The
Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for
such forward-looking statements. In order to comply with the terms of the safe
harbor, the Company notes that a variety of factors could cause actual results
and experience to differ materially from the anticipated results or other
expectations expressed in such forward-looking statements. Also, the Company
notes that owners of Applera Corporation - Applied Biosystems Group Common Stock
and Applera Corporation - Celera Genomics Group Common Stock are subject to
risks arising from their ownership of common stock of a corporation with two
separate classes of common stock. The risks and uncertainties that may affect
the operations, performance, development, and results of the Company's business,
and the risks arising from a capital structure with two separate classes of
common stock, include, but are not limited to:
Risks Relating to Applied Biosystems
Rapidly changing technology in life sciences could make Applied
Biosystems' product line obsolete unless it continues to improve
existing products, develop new products, and pursue new market
opportunities.
A significant portion of the net revenues for Applied Biosystems each
year is derived from products that did not exist in the prior year. Applied
Biosystems' future success depends on its ability to continually improve its
current products, develop and introduce, on a timely and cost-effective basis,
new products that address the evolving needs of its customers, and pursue new
market opportunities that develop as a result of technological and scientific
advances in life sciences. Applied Biosystems' products are based on complex
technology which is subject to rapid change as new technologies are developed
and introduced in the marketplace. Unanticipated difficulties or delays in
replacing existing products with new products could adversely affect Applied
Biosystems' future operating results. The pursuit of new market opportunities
will add further complexity and require additional management attention and
resources as these markets are addressed.
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Applied Biosystems' new Knowledge Business may not be successful.
In April 2002, Applied Biosystems became the exclusive distributor of
Celera Genomics' Celera Discovery System and related human genomic and other
biological and medical information under the terms of a 10-year marketing and
distribution agreement. Applied Biosystems expects to integrate the Celera
Discovery System and Celera Genomics' related information into a new Knowledge
Business that combines current Applied Biosystems assay, human identification
and forensics, and cell biology products with new biological information content
and analytical tools. The Knowledge Business is an emerging business, and
Applied Biosystems believes that in order for it to be successful Applied
Biosystems may have to devote a significant amount of resources to researching,
developing, marketing, and distributing Knowledge Business products and
services. The market for these products and services is intensely competitive,
and there can be no assurance that there will be market acceptance of the
utility and value of the product and service offerings of the Knowledge
Business.
A significant portion of sales depends on customers' capital spending
policies that may be subject to significant and unexpected decreases.
A significant portion of Applied Biosystems' instrument product sales
are capital purchases by its customers. Applied Biosystems' customers include
pharmaceutical, environmental, research, biotechnology, and chemical companies,
and the capital spending policies of these companies can have a significant
effect on the demand for Applied Biosystems' products. These policies are based
on a wide variety of factors, including the resources available to make
purchases, the spending priorities among various types of research equipment,
and policies regarding capital expenditures during recessionary periods. Any
decrease in capital spending or change in spending policies of these companies
could significantly reduce the demand for Applied Biosystems' products.
A substantial portion of Applied Biosystems' sales is to customers at
universities or research laboratories whose funding is dependent on
both the level and timing of funding from government sources.
As a result, the timing and amount of revenues from these sources may
vary significantly due to factors that can be difficult to forecast. Although
research funding has increased during the past several years, grants have, in
the past, been frozen for extended periods or otherwise become unavailable to
various institutions, sometimes without advance notice. Budgetary pressures may
result in reduced allocations to government agencies that fund research and
development activities. If government funding necessary to purchase Applied
Biosystems' products were to become unavailable to researchers for any extended
period of time, or if overall research funding were to decrease, the business of
Applied Biosystems could be adversely affected.
Applied Biosystems is currently and could in the future be subject to
claims for infringement of patents and other intellectual property
rights.
Applied Biosystems' products are based on complex, rapidly developing
technologies. These products could be developed without knowledge of previously
filed patent applications that mature into patents that cover some aspect of
these technologies. In addition, there are relatively few decided court cases
interpreting the scope of patent claims in these technologies, and Applied
Biosystems' belief that its products do not infringe the technology covered by
valid
-41-
and enforceable patents could be successfully challenged by third parties. Also,
in the course of its business, Applied Biosystems may from time to time have
access to confidential or proprietary information of third parties, and these
parties could bring a theft of trade secret claim against Applied Biosystems
asserting that Applied Biosystems' products improperly use technologies which
are not patented but which are protected as trade secrets. Applied Biosystems
has been made a party to litigation regarding intellectual property matters,
including the litigation described in the following paragraph, some of which, if
determined adversely, could have a material adverse effect on Applied
Biosystems. Due to the fact that Applied Biosystems' business depends in large
part on rapidly developing and dynamic technologies, there remains a constant
risk of intellectual property litigation affecting the group. Applied Biosystems
has from time to time been notified that it may be infringing patents and other
intellectual property rights of others. It may be necessary or desirable in the
future to obtain licenses relating to one or more products or relating to
current or future technologies, and Applied Biosystems cannot be assured that it
will be able to obtain these licenses or other rights on commercially reasonable
terms.
MJ Research, Inc. has filed a lawsuit against the Company based on the
allegation that four patents underlying Applied Biosystems' DNA sequencing
instruments were invalidly obtained because one of the alleged inventors, whose
work was funded in part by the United States government, was knowingly omitted
from the patent applications. MJ Research claims to be suing in the name of the
United States government although the government has to date declined to
participate in the lawsuit. Promega Corporation has filed a lawsuit against the
Company alleging that Applied Biosystems, along with certain other named
defendants, is infringing two Promega patents due to the sale of forensic
identification and paternity testing kits. Beckman Coulter, Inc. has filed a
lawsuit against the Company alleging that Applied Biosystems is infringing three
Beckman Coulter patents, although it has not identified the specific facts on
which the allegation is based. At present, only the Promega litigation is
scheduled for trial. If any of these matters does proceed to trial, the cost of
the litigation, and the amount of management time that will be devoted to the
litigation, will be significant. There can be no assurance that these matters
will be resolved favorably, that the Company, Applied Biosystems, or Celera
Genomics will not be enjoined from selling the products in question or other
products as a result, or that any monetary or other damages assessed against the
Company will not have a material adverse effect on the financial condition of
the Company, Applied Biosystems, or Celera Genomics.
Since Applied Biosystems' business is dependent on foreign sales,
fluctuating currencies will make revenues and operating results more
volatile.
Approximately 50% of Applied Biosystems' net revenues during fiscal
2002 were derived from sales to customers outside of the United States. The
majority of these sales were based on the relevant customer's local currency. A
significant portion of the related costs for Applied Biosystems are based on the
U.S. dollar. As a result, Applied Biosystems' reported and anticipated operating
results and cash flows are subject to fluctuations due to material changes in
foreign currency exchange rates that are beyond Applied Biosystems' control.
Integrating acquired technologies may be costly and may not result in
technological advances.
The future growth of Applied Biosystems depends in part on its ability
to acquire complementary technologies through acquisitions and investments. The
consolidation of
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employees, operations, and marketing and distribution methods could present
significant managerial challenges. For example, Applied Biosystems may encounter
operational difficulties in the integration of manufacturing or other
facilities. In addition, technological advances resulting from the integration
of technologies may not be achieved as successfully or rapidly as anticipated,
if at all.
Applied Biosystems' Knowledge Business depends on the continuous,
effective, reliable, and secure operation of its computer hardware,
software, and Internet applications and related tools and functions.
Because Applied Biosystems' Knowledge Business requires manipulating
and analyzing large amounts of data, and communicating the results of the
analysis to its internal research personnel and to its customers via the
Internet, Applied Biosystems depends on the continuous, effective, reliable, and
secure operation of its computer hardware, software, networks, Internet servers,
and related infrastructure. To the extent that Applied Biosystems' hardware or
software malfunctions or access to Applied Biosystems' data by internal
Knowledge Business research personnel or Knowledge Business customers through
the Internet is interrupted, the Knowledge Business could suffer.
Applied Biosystems' computer and communications hardware is protected
through physical and software safeguards. However, it is still vulnerable to
fire, storm, flood, power loss, earthquakes, telecommunications failures,
physical or software break-ins, and similar events. In addition, the Knowledge
Business online products are complex and sophisticated, and as such, could
contain data, design, or software errors that could be difficult to detect and
correct. Software defects could be found in current or future products. If
Applied Biosystems fails to maintain and further develop the necessary computer
capacity and data to support its computational needs and its customers' access
to the Knowledge Business product offerings, it could experience a loss of or
delay in revenues or market acceptance. In addition, any sustained disruption in
Internet access provided by third parties could adversely affect the Knowledge
Business.
Electricity shortages and earthquakes could disrupt operations in
California.
The headquarters and principal operations of Applied Biosystems are
located in Foster City, California. In 2001, the State of California experienced
a statewide electricity shortage due to a variety of factors. Although some of
the factors causing this shortage have been eliminated or mitigated, there are
ongoing concerns about the availability of electricity in California,
particularly during peak usage periods. Blackouts in Foster City, even of modest
duration, could impair or cause a temporary suspension of the group's
operations, including the manufacturing and shipment of new products. Power
disruptions of an extended duration or high frequency could have a material
adverse effect on operating results. In addition, Foster City is located near
major California earthquake faults. The ultimate impact of earthquakes on
Applied Biosystems, its significant suppliers, and the general infrastructure is
unknown, but operating results could be materially affected in the event of a
major earthquake.
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Risks Relating to Celera Genomics
Celera Genomics has incurred net losses to date and may not achieve
profitability.
Celera Genomics has accumulated net losses of $576.8 million as of June
30, 2002, and expects that it will continue to incur additional net losses for
the foreseeable future. These cumulative losses are expected to increase as
Celera Genomics continues to make investments in new technology and product
development, including its investments in its therapeutics business and the
Applera Genomics Initiative, as well as investments in diagnostics through
Celera Diagnostics, its joint venture with Applied Biosystems. Celera Genomics
will record all initial operating losses of Celera Diagnostics up to a maximum
of $300 million, after which any additional operating losses would be shared
equally by Celera Genomics and Applied Biosystems. As an early stage business,
Celera Genomics faces significant challenges in expanding its operations into
the therapeutics research and development business. As a result, there is a high
degree of uncertainty that Celera Genomics will be able to achieve profitable
operations.
Celera Genomics has entered into an exclusive arrangement with Applied
Biosystems to distribute the Celera Discovery System and related
information as part of Applied Biosystems' new Knowledge Business, and
the revenue that Celera Genomics receives from Applied Biosystems will
depend heavily on Applied Biosystems' ability to market and distribute
its Knowledge Business products.
Effective April 2002, Applied Biosystems became the exclusive
distributor of Celera Discovery System and Celera Genomics' related human
genomic and other biological and medical information under the terms of a
ten-year marketing and distribution agreement. Celera Genomics expects that
Applied Biosystems will integrate the Celera Discovery System and the related
information into a new Knowledge Business that combines current Applied
Biosystems assay, human identification and forensics, and cell biology products
with new biological information content and analytical tools.
Under the terms of the agreement, Applied Biosystems is obligated to
pay a royalty to Celera Genomics based on sales, if any, of certain Knowledge
Business products after July 1, 2002. Whether Celera Genomics actually receives
any royalties from Applied Biosystems under this agreement, and the amount of
these royalties, depends on Applied Biosystems' ability to successfully
commercialize Knowledge Business products subject to the royalty. The Knowledge
Business is an emerging business, and Applied Biosystems has not proven its
ability to successfully commercialize these products. Celera Genomics believes
that in order for the Knowledge Business to be successful, Applied Biosystems
may have to devote a significant amount of its resources to researching,
developing, marketing, and distributing Knowledge Business products and
services. However, Celera Genomics has no control over the amount and timing of
Applied Biosystems' use of its resources, including for products subject to
Celera Genomics' royalty. In addition, the market for these products is
intensely competitive, and there can be no assurance that there will be market
acceptance of the utility and value of the product offerings of the Knowledge
Business.
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Celera Genomics does not intend to seek any new customers for its
Celera Discovery System and related information products and services
after June 30, 2002, and therefore its future revenues from these
products and services will be limited.
Under the terms of the marketing and distribution agreement between
Celera Genomics and Applied Biosystems, Celera Genomics will receive all
revenues under, and be responsible for all costs and expenses associated with,
Celera Discovery System and related information contracts that were in effect on
April 1, 2002, the effective date of the agreement, or which were entered into
during a three-month transition period ended June 30, 2002 (as well as renewals
of these contracts, if any). However, the revenue anticipated by Celera Genomics
under these contracts could be adversely impacted as a result of changes made to
Celera Discovery System products by or at the request of Applied Biosystems
pursuant to the agreement, although Applied Biosystems has agreed to reimburse
Celera Genomics for any shortfall in earnings before interest, taxes,
depreciation, and amortization from these contracts below $62.5 million (as well
as renewals, if any) during the four fiscal years ending with the 2006 fiscal
year if the shortfall is due to these changes, provided Celera Genomics
otherwise continues to perform under these contracts. However, during the term
of the marketing and distribution agreement (other than the transition period),
Celera Genomics will not be marketing Celera Discovery System products and
services to, and will not be contracting with, new customers. Accordingly,
except for the anticipated revenue under Celera Discovery System contracts
existing on June 30, 2002 and renewals of these contracts, if any, and the
Applied Biosystems' corresponding reimbursement obligation, Celera Genomics does
not expect any revenues from Celera Discovery System and related products and
services other than the potential royalty payments from Applied Biosystems under
the marketing and distribution agreement. Although under certain contracts with
existing Celera Discovery System customers Celera Genomics is entitled to
milestone payments or future royalties based on products developed by its
customers, Celera Genomics believes these arrangements are unlikely to produce
any significant revenue for the group.
Celera Genomics' ability to maintain its relationships with existing
Celera Discovery System customers depends heavily on continued assembly
and annotation of the human and mouse genomes.
In June 2000, Celera Genomics and the Human Genome Project each
announced the "first assembly" of the human genome, and in April 2001, Celera
Genomics announced the assembly of the mouse genome. Assembly is the process by
which individual fragments of DNA, the molecule that forms the basis of the
genetic material in virtually all living organisms, are pieced together into
their appropriate order and place on each chromosome within the genome. Celera
Genomics' first assembly of the human genome covered approximately 95% of that
genome, and its assembly of the mouse genome covered approximately 99% of that
genome. Celera Genomics intends to continue updating the assembly of the human
and mouse genomes as it continues to annotate these genomes. Annotation is the
process of assigning features or characteristics to each chromosome. Each gene
on each chromosome is given a name, its structural features are described, and
proteins encoded by genes are classified into possible or known function. Celera
Genomics' ability to maintain its relationship with the existing Celera
Discovery System customers depends heavily upon the continued assembly and
annotation of these genomes. Failure to continue to update the assembly and
annotation efforts in a timely manner may have a material adverse effect on
Celera Genomics' revenues.
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Celera Genomics' ability to develop and commercialize proprietary
therapeutics is unproven.
As Celera Genomics expands its therapeutics discovery and development
business, it faces the difficulties inherent in developing and commercializing
therapeutic products. It is possible that Celera Genomics' discovery and
development efforts will not result in any commercial products or services. In
particular, Celera Genomics and its collaborators are seeking to develop new
therapeutic products based on information derived from the study of the genetic
material of organisms, or genomics, and the study of proteins, or proteomics.
These methods are unproven, as few therapeutic products based on genomic or
proteomic discoveries have been developed and commercialized and, to date, no
one has developed or commercialized any therapeutic products based on Celera
Genomics' technologies.
Therapeutic product candidates may never result in a commercialized
product.
All of Celera Genomics' therapeutic product candidates are in various
stages of research and development and will require significant additional
research and development efforts by Celera Genomics or its collaborators before
they can be marketed. These efforts include extensive preclinical and clinical
testing and lengthy regulatory review and clearance or approval by the United
States Food and Drug Administration and comparable agencies in other countries.
The development of Celera Genomics' new therapeutics products is highly
uncertain and subject to a number of significant risks. To date, Celera Genomics
has not commercialized a therapeutic product and Celera Genomics does not expect
any of its therapeutic product candidates to be commercially available for a
number of years, if ever. Therapeutic product candidates that appear to be
promising at early stages of development may not be developed into commercial
products, or may not be successfully marketed, for a number of reasons,
including:
o Celera Genomics or its collaborators may not successfully
complete any research and development efforts;
o Celera Genomics or its collaborators may not successfully
build the necessary preclinical and clinical development
organizations;
o any therapeutic product candidates Celera Genomics or its
collaborators develop may be found during preclinical testing
or clinical trials to be ineffective or to cause harmful side
effects;
o Celera Genomics or its collaborators may fail to obtain
required regulatory approvals for products they develop;
o Celera Genomics or its collaborators may be unable to
manufacture enough of any potential products at an acceptable
cost and with appropriate quality;
o Celera Genomics or its collaborators may fail to build
necessary distribution channels;
o Celera Genomics' or its collaborator's products may not be
competitive with other existing or future products;
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o adequate reimbursement for Celera Genomics' or its
collaborators products may not be available to physicians and
patients from the government or insurance companies; and
o Celera Genomics or its collaborators may be unable to obtain
necessary intellectual property protection, or third parties
may own proprietary rights that prevent Celera Genomics or its
collaborators from commercializing their products.
If Celera Genomics fails to maintain its existing collaborative
relationships and enter into new collaborative relationships, or if
collaborators do not perform under collaboration agreements,
development of its therapeutic product candidates could be delayed.
Celera Genomics' strategy for the discovery, development, clinical
testing, manufacturing and commercialization of most of its therapeutic product
candidates includes entering into collaborations with partners. Although Celera
Genomics has expended, and continues to expend, time and money on internal
research and development programs, it may be unsuccessful in creating
therapeutic product candidates that would enable it to form additional
collaborations and receive milestone and/or royalty payments from collaborators.
Each of Celera Genomics' existing collaboration agreements may be
canceled under certain circumstances. In addition, the amount and timing of
resources to be devoted to research, development, eventual clinical trials and
commercialization activities by Celera Genomics' collaborators are not within
Celera Genomics' control. Celera Genomics cannot ensure that its collaborators
will perform their obligations as expected. If any of Celera Genomics'
collaborators terminate or elect to cancel their agreements or otherwise fail to
conduct their collaborative activities in a timely manner, the development or
commercialization of therapeutic products may be delayed or otherwise adversely
affected. If in some cases Celera Genomics assumes responsibilities for
continuing programs on its own after termination of a collaboration, Celera
Genomics may be required to devote additional resources to product development
and commercialization or Celera Genomics may need to cancel certain development
programs.
If Celera Genomics fails to satisfy regulatory requirements for any
therapeutic product candidate, Celera Genomics will be unable to
complete the development and commercialization of that product.
Celera Genomics does not currently have the internal capability to move
potential products through clinical testing, manufacturing and the approval
processes of the United States Food and Drug Administration and comparable
agencies in other countries. In the United States, either Celera Genomics or its
collaborators must show through pre-clinical studies and clinical trials that
each of Celera Genomics' therapeutic product candidates is safe and effective in
humans for each indication before obtaining regulatory clearance from the United
States Food and Drug Administration for the commercial sale of that product.
Outside of the United States, the regulatory requirements vary from country to
country. If Celera Genomics or its collaborator fails to adequately show the
safety and effectiveness of a therapeutic product, regulatory clearance or
approval could be delayed or denied. The results from pre-clinical studies may
be different from the results that are obtained in large-scale clinical trials.
Celera Genomics cannot be certain that it will show sufficient safety and
effectiveness in its clinical trials to allow it to obtain the needed regulatory
clearance or approval. The regulatory review and approval process can take many
years and require substantial expense and may not be successful. Many
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companies in the therapeutic industry, including biotechnology companies, have
suffered significant setbacks in advanced clinical trials, even after promising
results in earlier studies.
Even if Celera Genomics obtains regulatory clearance or approval, it
will be subject to certain risks and uncertainties relating to regulatory
compliance, including: post-approval clinical studies and inability to meet the
compliance requirements of the United States Food and Drug Administration's Good
Manufacturing Practices regulations. In addition, identification of certain
adverse side effects after a therapeutic product is on the market or the
occurrence of manufacturing problems could cause subsequent suspension of
product manufacture or withdrawal of approval, or could require reformulation of
a therapeutic product, additional testing, or changes in labeling of the
product. This could delay or prevent Celera Genomics from generating revenues
from the sale of that therapeutic product.
Celera Genomics' research and product development, including its
proteomics efforts, depends on access to tissue samples and other
biological materials.
Celera Genomics will need access to human and other tissue samples from
diseased and healthy individuals, other biological materials, and related
clinical and other information, which may be in limited supply. Celera Genomics
may not be able to obtain or maintain access to these materials and information
on acceptable terms. In addition, government regulation in the United States and
foreign countries could result in restricted access to, or use of, human and
other tissue samples. If Celera Genomics loses access to sufficient numbers or
sources of tissue samples, or if tighter restrictions are imposed on its use of
the information generated from tissue samples, its business may be harmed.
The pharmaceutical industry is intensely competitive and evolving.
There is intense competition among pharmaceutical and biotechnology
companies attempting to discover candidates for potential new therapeutic
products. These companies may:
o develop new therapeutic products in advance of Celera
Genomics;
o develop therapeutic products which are more effective or more
cost-effective than those developed by Celera Genomics;
o obtain regulatory approvals of their therapeutic products more
rapidly than Celera Genomics; or
o obtain patent protection or other intellectual property rights
that would limit Celera Genomics' ability to develop and
commercialize therapeutic products.
Introduction of new products may expose Celera Genomics to product
liability claims.
New products developed by Celera Genomics or its collaborators could
expose Celera Genomics to potential product liability risks that are inherent in
the testing, manufacturing, marketing and sale of human therapeutic products.
Product liability claims or product recalls, regardless of the ultimate outcome,
could require Celera Genomics to spend significant time and money in litigation
and to pay significant damages. Although Celera Genomics expects to seek and
maintain product liability insurance to cover claims relating to the testing and
use of
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therapeutic products, there can be no assurance that such insurance will be
available on commercially reasonable terms, if at all, or that the amount of
coverage obtained will be adequate to cover losses from any particular claim.
The therapeutics discovery and development business is highly
technical, and there is a competitive market for personnel with the
necessary expertise to develop and expand Celera Genomics' therapeutics
business.
Celera Genomics believes that in order to develop and commercialize
therapeutic products, it will need to recruit and retain scientific and
management personnel having specialized training or advanced degrees, or
otherwise having the technical background, necessary for an understanding of
therapeutic products. There is a shortage of qualified scientific and management
who possess this technical background. Celera Genomics competes for these
personnel with other pharmaceutical and biotechnology companies, academic
institutions and government entities. If Celera Genomics is unable to retain and
attract qualified scientific and management personnel, the growth of the group's
therapeutics discovery and development business could be delayed or curtailed.
Celera Genomics could incur liabilities relating to hazardous materials
that it uses in its research and development activities.
Celera Genomics' research and development activities involve the
controlled use of hazardous materials, chemicals and various radioactive
materials. In the event of an accidental contamination or injury from these
materials, Celera Genomics could be held liable for damages in excess of its
resources.
Celera Genomics' business depends on the continuous, effective,
reliable, and secure operation of its computer hardware, software, and
Internet applications and related tools and functions.
Because Celera Genomics' business requires manipulating and analyzing
large amounts of data, and communicating the results of the analysis to its
internal research personnel and to its customers via the Internet, Celera
Genomics depends on the continuous, effective, reliable, and secure operation of
its computer hardware, software, networks, Internet servers, and related
infrastructure. To the extent that Celera Genomics' hardware or software
malfunctions or access to Celera Genomics' data by Celera Genomics' internal
research personnel or customers through the Internet is interrupted, its
business could suffer.
Celera Genomics' computer and communications hardware is protected
through physical and software safeguards. However, it is still vulnerable to
fire, storm, flood, power loss, earthquakes, telecommunications failures,
physical or software break-ins, and similar events. In addition, Celera
Genomics' online products are complex and sophisticated, and as such, could
contain data, design, or software errors that could be difficult to detect and
correct. Software defects could be found in current or future products. If
Celera Genomics fails to maintain and further develop the necessary computer
capacity and data to support its computational needs and its customers'
therapeutics discovery and research efforts, it could experience a loss of or
delay in revenues. In addition, any sustained disruption in Internet access
provided by third parties could adversely affect Celera Genomics' business.
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Celera Genomics' competitive position depends on maintaining its
intellectual property protection and obtaining licenses to intellectual
property it may need from others.
Celera Genomics' ability to compete and to achieve and maintain
profitability depends on its ability to protect its proprietary discoveries or
technology, in large part, through obtaining and enforcing patent rights,
obtaining copyright protection, maintaining its trade secrets, and operating
without infringing the intellectual property rights of others. Celera Genomics'
ability to obtain patent protection for the inventions it makes is uncertain.
The patentability of biotechnology and pharmaceutical inventions involves
complex factual and legal questions. As a result, it is difficult to predict
whether patents will issue or the breadth of claims that will be allowed in
biotechnology and pharmaceutical patents. This may be particularly true with
regard to the patenting of gene sequences, gene functions, and genetic
variations. In this regard, the United States Patent and Trademark Office has
adopted guidelines for use in the review of the utility of inventions,
particularly biotechnology inventions. These guidelines increased the amount of
evidence required to demonstrate utility in order to obtain a patent in the
biotechnology field, making patent protection more difficult to obtain. Although
others have been successful in obtaining patents to biotechnology inventions,
since the adoption of these guidelines, these patents have been issued with
increasingly less frequency. As a result, patents may not issue from patent
applications that Celera Genomics may own or license if the applicant is unable
to satisfy the new guidelines.
The United States Patent and Trademark Office has issued several
patents to third parties covering inventions involving single nucleotide
polymorphisms ("SNPs"), naturally occurring genetic variations that scientists
believe can be correlated with susceptibility to disease, disease prognosis,
therapeutic efficiency, and therapeutic toxicity. These inventions are subject
to the same new guidelines as other biotechnology inventions. In addition,
Celera Genomics may need to obtain rights to patented SNPs in order to develop,
use and sell analyses of the overall human genome or particular full-length
genes. These licenses may not be available to Celera Genomics on commercially
acceptable terms, or at all.
In some instances, patent applications in the United States are
maintained in secrecy until a patent issues. In most instances, the content of
United States and international patent applications is made available to the
public approximately 18 months after the application's filing date. As a result,
Celera Genomics cannot be certain that others have not filed patent applications
for inventions covered by Celera Genomics' patent applications or that Celera
Genomics inventors were the first to make the invention. Accordingly, Celera
Genomics' patent applications may be preempted or Celera Genomics may have to
participate in interference proceedings before the United States Patent and
Trademark Office. These proceedings determine the priority of invention and the
right to a patent for the claimed invention in the United States.
Furthermore, lawsuits may be necessary to enforce any patents issued to
Celera Genomics or to determine the scope and validity of the rights of third
parties. Lawsuits and interference proceedings, even if they are successful, are
expensive to pursue, and Celera Genomics could use a substantial amount of its
financial resources in either case. An adverse outcome could subject Celera
Genomics to significant liabilities to third parties and require Celera Genomics
to license disputed rights from third parties or to cease using the technology.
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Celera Genomics may be dependent on protecting its proprietary
databases through copyright law to prevent other organizations from taking
information from those databases and copying and reselling it. Copyright law
currently provides uncertain protection regarding the copying and resale of
factual data. Changes in copyright law could either expand or reduce the extent
to which Celera Genomics and its customers are able to protect their
intellectual property. Accordingly, Celera Genomics is uncertain as to whether
it can prevent such copying or resale through copyright law.
Celera Genomics also relies on trade secret protection for its
confidential and proprietary information and procedures, including procedures
related to sequencing genes and to searching and identifying important regions
of genetic information. Celera Genomics protects its trade secrets through
recognized practices, including access control, confidentiality and nonuse
agreements with employees, consultants, collaborators and customers, and other
security measures. These confidentiality and nonuse agreements may be breached,
however, and Celera Genomics may not have adequate remedies for a breach. In
addition, Celera Genomics' trade secrets may otherwise become known or be
independently developed by competitors. Accordingly, it is unclear whether
Celera Genomics' trade secrets will provide adequate protection.
Disputes may arise in the future with regard to the ownership of rights
to any invention developed with collaborators. These and other possible
disagreements with collaborators could lead to delays in the achievement of
milestones or receipt of royalty payments or in research, development and
commercialization of Celera Genomics' products. In addition, these disputes
could require or result in lawsuits or arbitration. Lawsuits and arbitration are
time-consuming and expensive. Even if Celera Genomics wins, the cost of these
proceedings could adversely affect its business, financial condition and
operating results.
Celera Genomics may infringe the intellectual property rights of third
parties and may become involved in expensive intellectual property
litigation.
The intellectual property rights of biotechnology companies, including
Celera Genomics, are generally uncertain and involve complex legal, scientific
and factual questions. Celera Genomics' success in therapeutics discovery and
development may depend, in part, on its ability to operate without infringing
the intellectual property rights of others and to prevent others from infringing
its intellectual property rights.
There has been substantial litigation regarding patents and other
intellectual property rights in the biotechnology and pharmaceutical industries.
Celera Genomics may become a party to patent litigation or proceedings at the
United States Patent and Trademark Office to determine its patent rights with
respect to third parties. Interference proceedings may be necessary to establish
which party was the first to make the invention sought to be patented. Celera
Genomics may become involved in patent litigation against third parties to
enforce its patent rights, to invalidate patents held by the third parties, or
to defend against these claims. The cost to Celera Genomics of any patent
litigation or similar proceeding could be substantial, and it may absorb
significant management time. If infringement litigation against Celera Genomics
is resolved unfavorably to Celera Genomics, Celera Genomics may be enjoined from
manufacturing or selling its products or services without a license from a third
party. Celera Genomics may not be able to obtain a license on commercially
acceptable terms, or at all.
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Ethical, legal and social issues related to the use of genetic
information and genetic testing may cause less demand for Celera
Genomics' products.
Genetic testing has raised issues regarding confidentiality and the
appropriate uses of the resulting information. For example, concerns have been
expressed regarding the use of genetic test results by insurance carriers or
employers to discriminate on the basis of this information, resulting in
barriers to the acceptance of genetic tests by consumers. This could lead to
governmental authorities calling for limits on or regulation of the use of
genetic testing or prohibiting testing for genetic predisposition to certain
diseases, particularly those that have no known cure. Any of these scenarios
could reduce the potential markets for products of Celera Genomics.
Future acquisitions and other transactions may absorb significant
resources, may be unsuccessful and could dilute the holders of Applera
Corporation - Celera Genomics Group Common Stock.
As part of Celera Genomics' strategy, it expects to pursue
acquisitions, investments and other strategic relationships and alliances.
Acquisitions, investments and other strategic relationships and alliances may
involve significant cash expenditures, debt incurrence, additional operating
losses, and expenses that could have a material effect on Celera Genomics'
financial condition and operating results. Acquisitions involve numerous other
risks, including:
o difficulties integrating acquired technologies and personnel
into the business of Celera Genomics;
o diversion of management from daily operations;
o inability to obtain required financing on favorable terms;
o entry into new markets in which Celera Genomics has little
previous experience;
o potential loss of key employees, key contractual
relationships, or key customers of acquired companies or of
Celera Genomics; and
o assumption of the liabilities and exposure to unforeseen
liabilities of acquired companies.
It may be difficult for Celera Genomics to complete these transactions
quickly and to integrate these businesses efficiently into its current business.
Any acquisitions, investments or other strategic relationships and alliances by
Celera Genomics may ultimately have a negative impact on its business and
financial condition. For example, future acquisitions may not be as successful
as originally anticipated and may result in special charges, such as the charges
for impairment of Paracel goodwill, intangibles and other assets and other
charges in the amounts of $69.1 million during fiscal 2001 and $25.9 million
during fiscal 2002 and for the Molecular Informatics business in the amount of
$14.5 million during fiscal 1999.
In addition, acquisitions and other transactions may involve the
issuance of a substantial amount of Applera Corporation - Celera Genomics Group
Common Stock without the approval of the holders of Applera Corporation - Celera
Genomics Group Common Stock. Any issuances
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of this nature will be dilutive to holders of Applera Corporation - Celera
Genomics Group Common Stock.
Applera Corporation - Celera Genomics Group Common Stock price is
highly volatile.
The market price of Applera Corporation - Celera Genomics Group Common
Stock has been and may continue to be highly volatile due to the risks and
uncertainties described in this section of this Annual Report on Form 10-K, as
well as other factors that may have affected or may in the future affect the
market price, such as:
o conditions and publicity regarding the genomics,
biotechnology, pharmaceutical, or life sciences industries
generally;
o price and volume fluctuations in the stock market at large
which do not relate to Celera Genomics' operating performance;
and
o comments by securities analysts or government officials,
including with regard to the viability or profitability of the
biotechnology sector generally or with regard to intellectual
property rights of biotechnology companies, or Celera
Genomics' failure to meet market expectations.
The stock market has from time to time experienced extreme price and
volume fluctuations that are unrelated to the operating performance of
particular companies. In the past, companies that have experienced volatility
have sometimes been the subjects of securities class action litigation. If
litigation was instituted on this basis, it could result in substantial costs
and a diversion of management's attention and resources.
The Company is subject to a purported class action lawsuit relating to
its 2000 offering of shares of Applera Corporation - Celera Genomics
Group Common Stock that may be expensive and time consuming.
The Company and some of its officers were served in five lawsuits
purportedly on behalf of purchasers of Applera Corporation - Celera Genomics
Group Common Stock in the Company's follow-on public offering of Applera
Corporation - Celera Genomics Group Common Stock completed on March 6, 2000. In
the offering, the Company sold an aggregate of approximately 4.4 million shares
of Applera Corporation - Celera Genomics Group Common Stock at a public offering
price of $225 per share. All of these lawsuits have been consolidated into a
single case and an amended consolidated complaint was filed on August 21, 2001.
The consolidated complaint generally alleges that the prospectus used in
connection with the offering was inaccurate or misleading because it failed to
adequately disclose the alleged opposition of the Human Genome Project and two
of its supporters, the governments of the United States and the United Kingdom,
to providing patent protection to the Company's genomic-based products. Although
Celera Genomics has never sought, or intended to seek, a patent on the basic
human genome sequence data, the complaint also alleges that the Company did not
adequately disclose the risk that it would not be able to patent this data. The
consolidated complaint seeks unspecified monetary damages, rescission, costs and
expenses, and other relief as the court deems proper. The Company and the other
defendants have filed a motion to dismiss the case, which motion is pending
before the court. Although the Company believes the asserted claims are without
merit and intends to defend the case vigorously, the outcome of this or any
other
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litigation is inherently uncertain. The defense of this case will require
management attention and resources.
Risks Relating to Celera Diagnostics, a Joint Venture Between Applied
Biosystems and Celera Genomics
Celera Diagnostics' ability to develop and commercialize proprietary
diagnostic products is unproven.
Celera Diagnostics faces the difficulties inherent in developing and
commercializing diagnostic products. It is possible that Celera Diagnostics'
discovery and development efforts will not result in any commercial products or
services. In particular, Celera Diagnostics and its collaborators are seeking to
develop new diagnostic products based on information derived from the study of
the genetic material of organisms, or genomics, and the study of proteins, or
proteomics. This method carries inherent risks, as only a limited number of
diagnostic products based on genomic or proteomic discoveries have been
developed and commercialized to date.
Diagnostic product candidates may never result in a commercialized
product.
Most of Celera Diagnostics' potential diagnostic products are in
various stages of research and development and will require significant
additional research and development efforts by Celera Diagnostics or its
collaborators before they can be marketed. These efforts include extensive
clinical testing and may require lengthy regulatory review and clearance or
approval by the United States Food and Drug Administration and comparable
agencies in other countries. The development of Celera Diagnostics' new
diagnostics products is highly uncertain and subject to a number of significant
risks. Diagnostic product candidates that appear to be promising at early stages
of development may not be developed into commercial products, or may not be
successfully marketed, for a number of reasons, including:
o Celera Diagnostics or its collaborators may not successfully
complete any research and development efforts;
o any diagnostic products Celera Diagnostics or its
collaborators develop may be found during clinical trials to
have limited medical value;
o Celera Diagnostics or its collaborators may fail to obtain
required regulatory approvals for products they develop;
o Celera Diagnostics or its collaborators may be unable to
manufacture enough of any potential products at an acceptable
cost and with appropriate quality;
o any diagnostic products Celera Diagnostics or its
collaborators develop may not be competitive with other
existing or future products;
o adequate reimbursement for Celera Diagnostics' and its
collaborators' products may not be available to physicians or
patients from the government or insurance companies; and
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o Celera Diagnostics may be unable to obtain necessary
intellectual property protection, or third parties may own
proprietary rights that prevent Celera Diagnostics or its
collaborators from commercializing their products.
If Celera Diagnostics fails to satisfy regulatory requirements for any
diagnostic product candidate, it may be unable to complete the
development and commercialization of that product.
Celera Diagnostics is currently developing its capability to move
potential products through clinical testing, manufacturing, and the approval
processes of the United States Food and Drug Administration and comparable
agencies in other countries. In the United States, either Celera Diagnostics or
its collaborators must show through pre-clinical studies and clinical trials
that each of Celera Diagnostics' diagnostic product candidates is safe and
effective for each indication before obtaining regulatory clearance from the
United States Food and Drug Administration for the commercial sale of that
product. Outside of the United States, the regulatory requirements vary from
country to country. If Celera Diagnostics or its collaborator fails to
adequately show the safety and effectiveness of a diagnostic product, regulatory
clearance or approval could be delayed or denied. The results from pre-clinical
studies may be different from the results that are obtained in large-scale
clinical trials. Celera Diagnostics cannot be certain that it will show
sufficient safety and effectiveness in its clinical trials to allow it to obtain
the needed regulatory clearance or approval. The regulatory review and approval
process can take many years and require substantial expense and may not be
successful. A number of companies in the diagnostics industry, including
biotechnology companies, have suffered significant setbacks in advanced clinical
trials, even after promising results in earlier studies.
Even if Celera Diagnostics obtains regulatory clearance or approval, it
will be subject to certain risks and uncertainties relating to regulatory
compliance, including: post-approval clinical studies and inability to meet the
compliance requirements of the United States Food and Drug Administration's Good
Manufacturing Practices (Quality System) regulations. In addition, the
occurrence of manufacturing problems could cause subsequent suspension of
product manufacture or withdrawal of approval, or could require reformulation of
a diagnostic product, additional testing, or changes in labeling of the product.
This could delay or prevent Celera Diagnostics from generating revenues from the
sale of that diagnostic product.
Celera Diagnostics' products may not be fully accepted by physicians
and laboratories.
Celera Diagnostics' growth and success will depend on market acceptance
by physicians and laboratories of its products as clinically useful and
cost-effective. Celera Diagnostics expects that most of its products will use
genotyping and gene expression information to predict predisposition to
diseases, disease progression or severity, or responsiveness to treatment.
Market acceptance will depend on the widespread acceptance and use by doctors
and clinicians of genetic testing for these purposes. The use of genotyping and
gene expression information by doctors and clinicians for these purposes is
relatively new. Celera Diagnostics cannot be certain that doctors and clinicians
will want to use its products designed for these purposes.
Even if genetic testing is accepted as a method to manage health
care, Celera Diagnostics cannot be certain that its products will be accepted in
the clinical diagnostic market. If genetic testing becomes widely accepted in
the clinical diagnostic market, Celera Diagnostics
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cannot predict the extent to which doctors and clinicians may be willing to
utilize Celera Diagnostics' products in providing patient care. Doctors and
clinicians may prefer competing technologies and products that can be used for
the same purposes as Celera Diagnostics' products.
Ethical, legal and social issues related to the use of genetic
information and genetic testing may cause less demand for Celera
Diagnostics' products.
Genetic testing has raised issues regarding confidentiality and the
appropriate uses of the resulting information. For example, concerns have been
expressed regarding the use of genetic test results by insurance carriers or
employers to discriminate on the basis of this information, resulting in
barriers to the acceptance of genetic tests by consumers. This could lead to
governmental authorities calling for limits on or regulation of the use of
genetic testing or prohibiting testing for genetic predisposition to certain
diseases, particularly those that have no known cure. Any of these scenarios
could reduce the potential markets for products of Celera Diagnostics.
If insurance companies and other third-party payors do not reimburse
doctors and patients for Celera Diagnostics' tests, its ability to sell
its products to the clinical diagnostics market will be impaired.
Sales of Celera Diagnostics' products will depend, in large part, on
the availability of adequate reimbursement to users of those products from
government insurance plans, including Medicare and Medicaid in the United
States, managed care organizations, and private insurance plans. Physicians'
recommendations to use diagnostic tests, as well as decisions by patients to
pursue those tests, are likely to be influenced by the availability of
reimbursement by insurance companies and other third party payors. Third-party
payors are increasingly attempting to contain health care costs by limiting both
the extent of coverage and the reimbursement rate for testing and treatment
products and services. In particular, products and services that are determined
to be investigational in nature or that are not considered "reasonably and
necessary" for diagnosis or treatment may be denied reimbursement coverage. In
addition, third-party payors are increasingly limiting reimbursement coverage
for medical diagnostic products and, in many instances, are exerting pressure on
medical suppliers to reduce their prices. Thus, third-party reimbursement may
not be consistently available or financially adequate to cover the cost of
Celera Diagnostics' products. This could limit the ability of Celera Diagnostics
to sell its products, cause Celera Diagnostics to reduce the prices of its
products, or otherwise adversely affect Celera Diagnostics' operating results.
Because each third-party payor individually approves reimbursement,
obtaining these approvals is a time-consuming and costly process that requires
Celera Diagnostics to provide scientific and clinical support for the use of
each of its products to each payor separately with no assurance that such
approval will be obtained. This process can delay the broad market introduction
of new products and could have a negative effect on Celera Diagnostics' revenues
and operating results.
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If Celera Diagnostics fails to maintain its existing collaborative
relationships and enter into new collaborative relationships, or if
collaborators do not perform under collaboration agreements,
development of its diagnostic products could be delayed.
Celera Diagnostics' strategy for the discovery, development, clinical
testing, manufacturing and commercialization of most of its diagnostic product
candidates includes entering into collaborations with partners. Although Celera
Diagnostics has expended, and continues to expend, time and money on internal
research and development programs, it may be unsuccessful in creating diagnostic
product candidates that would enable it to form additional collaborations.
Celera Diagnostics has entered into a strategic alliance agreement with
Abbott Laboratories for the joint discovery, development, manufacturing, and
commercialization of nucleic acid-based diagnostic products. The Abbott
Laboratories agreement may be terminated by the non-breaching party in the event
of a material breach and, under certain circumstances, by either party in the
event of a change in control of the other party. In addition, the amount and
timing of resources to be devoted to research, development, eventual clinical
trials and commercialization activities by Abbott are not within Celera
Diagnostics' control. Future collaborations with other third parties are likely
to be subject to similar terms and conditions. Celera Diagnostics cannot ensure
that its collaborators will perform their obligations as expected. If any of
Celera Diagnostics' collaborators terminate or elect to cancel their agreements
or otherwise fail to conduct their collaborative activities in a timely manner,
the development or commercialization of diagnostics products may be delayed or
otherwise adversely affected. If in some cases Celera Diagnostics assumes
responsibilities for continuing programs on its own after termination of a
collaboration, Celera Diagnostics may be required to devote additional resources
to product development and commercialization or Celera Diagnostics may need to
cancel certain development programs.
Celera Diagnostics does not have marketing capability in the clinical
diagnostic market.
Celera Diagnostics currently does not have a marketing organization.
Accordingly, its ability to successfully sell its products will depend on its
ability to either develop a marketing organization or work with Abbott
Laboratories under their current agreement, or a combination of both. In
jurisdictions where Celera Diagnostics uses third party distributors, its
success will depend to a great extent on the efforts of the distributors.
Celera Diagnostics has limited manufacturing capability and may
encounter difficulties expanding Celera Diagnostics' operations.
Celera Diagnostics has limited commercial manufacturing experience and
capabilities. If product sales increase, Celera Diagnostics will have to
increase the capacity of its manufacturing processes and facilities or rely on
its collaborators, if any. Celera Diagnostics may encounter difficulties in
scaling-up manufacturing processes and may be unsuccessful in overcoming such
difficulties. In such circumstances, Celera Diagnostics' ability to meet product
demand may be impaired or delayed.
Celera Diagnostics' facilities are subject, on an ongoing basis, to the
United States Food and Drug Administration's Good Manufacturing Practices
(Quality System) regulations, international quality standards and other
regulatory requirements, including requirements for
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good manufacturing practices. Celera Diagnostics may encounter difficulties
expanding Celera Diagnostics' manufacturing operations in accordance with these
regulations and standards, which could result in a delay or termination of
manufacturing or an inability to meet product demand.
Celera Diagnostics is currently operating its manufacturing at an
Applied Biosystems group facility, and intends to relocate these operations to a
new facility currently under construction. Celera Diagnostics expects to operate
its manufacturing out of a single facility for the foreseeable future, and it
does not have alternative production plans in place or alternative facilities
available should its existing manufacturing facility or its new manufacturing
facility, after completion of and relocation to this facility, cease to
function. Accordingly, Celera Diagnostics' business could be adversely affected
by unexpected interruptions in manufacturing caused by events such as labor
problems, equipment failures, or other factors, and the resulting inability to
meet customer orders on a timely basis.
Celera Diagnostics' research and product development depends on access
to tissue samples and other biological materials.
Celera Diagnostics needs access to human tissue samples from diseased
and healthy individuals, other biological materials, and related clinical and
other information, which may be in limited supply. Celera Diagnostics may not be
able to obtain or maintain access to these materials and information on
acceptable terms. In addition, government regulation in the United States and
foreign countries could result in restricted access to, or use of, human tissue
samples. If Celera Diagnostics loses access to sufficient numbers or sources of
tissue samples, or if tighter restrictions are imposed on its use of the
information generated from tissue samples, its business may be harmed.
Single suppliers or a limited number of suppliers provide key
components of Celera Diagnostics' products. If these suppliers fail to
supply these components, Celera Diagnostics may be unable to satisfy
product demand.
Several key components of Celera Diagnostics' products come from, or
are manufactured for Celera Diagnostics by, a single supplier or a limited
number of suppliers. This applies in particular to components such as enzymes
and fluorescent dyes. Celera Diagnostics acquires some of these and other key
components on a purchase-order basis, meaning that the supplier is not required
to supply Celera Diagnostics with specified quantities over longer periods of
time or set-aside part of its inventory for Celera Diagnostics' forecasted
requirements. Celera Diagnostics has not arranged for alternative supply sources
for some of these components and it may be difficult to find alternative
suppliers, especially to replace enzymes and fluorescent dyes. If Celera
Diagnostics' product sales increase beyond the forecast levels, or if its
suppliers are unable or unwilling to supply it on commercially acceptable terms,
it may not have access to sufficient quantities of key components on a timely
basis and may be unable to satisfy product demand.
In addition, if any of the components of Celera Diagnostics' products
are no longer available in the marketplace, it may be forced to further develop
its products or technology to incorporate alternate components. The
incorporation of new components into its products may require Celera Diagnostics
to seek approvals from the United States Food and Drug Administration or foreign
regulatory agencies prior to commercialization.
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Celera Diagnostics' competitive position depends on maintaining its
intellectual property protection and obtaining licenses to intellectual
property it may need from others.
Celera Diagnostics' ability to compete and to achieve and maintain
profitability depends on its ability to protect its proprietary discoveries or
technologies, in large part, through obtaining and enforcing patent rights,
maintaining its trade secrets, and operating without infringing the intellectual
property rights of others. Celera Diagnostics' ability to obtain patent
protection for the inventions it makes is uncertain. The patentability of
biotechnology inventions involves complex factual and legal questions. As a
result, it is difficult to predict whether patents will issue or the breadth of
claims that will be allowed in biotechnology and pharmaceutical patents. This
may be particularly true with regard to the patenting of gene sequences, gene
functions, and genetic variations. In this regard, the United States Patent and
Trademark Office has adopted guidelines for use in the review of the utility of
inventions, particularly biotechnology inventions. These guidelines increased
the amount of evidence required to demonstrate utility in order to obtain a
patent in the biotechnology field, making patent protection more difficult to
obtain. Although others have been successful in obtaining patents to
biotechnology inventions, since the adoption of these guidelines, these patents
have been issued with increasingly less frequency. As a result, patents may not
issue from patent applications that Celera Diagnostics may own or license if the
applicant is unable to satisfy the new guidelines.
In some instances, patent applications in the United States are
maintained in secrecy until a patent issues. In most instances, the content of
United States and international patent applications is made available to the
public approximately 18 months after the application's filing date. As a result,
Celera Diagnostics cannot be certain that others have not filed patent
applications for inventions covered by Celera Diagnostics' patent applications
or that Celera Diagnostics inventors were the first to make the invention.
Accordingly, Celera Diagnostics' patent applications may be preempted or Celera
Diagnostics may have to participate in interference proceedings before the
United States Patent and Trademark Office. These proceedings determine the
priority of invention and the right to a patent for the claimed invention in the
United States.
Furthermore, lawsuits may be necessary to enforce any patents issued to
Celera Diagnostics or to determine the scope and validity of the patent rights
of third parties. Lawsuits and interference proceedings, even if they are
successful, are expensive to pursue, and Celera Diagnostics could use a
substantial amount of its financial resources in either case. An adverse outcome
could subject Celera Diagnostics to significant liabilities to third parties and
require Celera Diagnostics to license disputed rights from third parties or to
cease development or sales of a product.
Celera Diagnostics also relies on trade secret protection for its
confidential and proprietary information and procedures. Celera Diagnostics
protects its trade secrets through recognized practices, including access
control, confidentiality and nonuse agreements with employees, consultants,
collaborators and customers, and other security measures. These confidentiality
and nonuse agreements may be breached, however, and Celera Diagnostics may not
have adequate remedies for a breach. In addition, Celera Diagnostics' trade
secrets may otherwise become known or be independently developed by competitors.
Accordingly, it is unclear whether Celera Diagnostics' trade secrets will
provide adequate protection.
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Disputes may arise in the future with regard to the ownership of rights
to any invention developed with collaborators. These and other possible
disagreements with collaborators could lead to delays in the achievement of
milestones or receipt of royalty payments or in research, development, and
commercialization of Celera Diagnostics' products. In addition, these disputes
could require or result in lawsuits or arbitration. Lawsuits and arbitration are
time-consuming and expensive. Even if Celera Diagnostics wins, the cost of these
proceedings could adversely affect its business, financial condition and
operating results.
Celera Diagnostics may infringe the intellectual property rights of
third parties and may become involved in expensive intellectual
property litigation.
The intellectual property rights of biotechnology companies, including
Celera Diagnostics, are generally uncertain and involve complex legal,
scientific and factual questions. Celera Diagnostics' success in diagnostic
discovery and development may depend, in part, on its ability to operate without
infringing the intellectual property rights of others and to prevent others from
infringing its intellectual property rights.
There has been substantial litigation regarding patents and other
intellectual property rights in the biotechnology and pharmaceutical industries.
Celera Diagnostics may become a party to patent litigation or proceedings at the
United States Patent and Trademark Office to determine its patent rights with
respect to third parties. Interference proceedings may be necessary to establish
which party was the first to make the invention sought to be patented. Celera
Diagnostics may become involved in patent litigation against third parties to
enforce its patent rights, to invalidate patents held by the third parties, or
to defend against these claims. The cost to Celera Diagnostics of any patent
litigation or similar proceeding could be substantial, and it may absorb
significant management time. If infringement litigation against Celera
Diagnostics is resolved unfavorably to Celera Diagnostics, Celera Diagnostics
may be enjoined from manufacturing or selling its products or services without a
license from a third party. Celera Diagnostics may not be able to obtain a
license on commercially acceptable terms, or at all.
Introduction of new products may expose Celera Diagnostics to product
liability claims.
New products developed by Celera Diagnostics or its collaborators could
expose Celera Diagnostics to potential product liability risks that are inherent
in the testing, manufacturing, marketing and sale of human diagnostic products.
In addition, clinicians, patients, third-party payors, and others may at times
seek damages based on testing or analysis errors based on a technician's
misreading of results, mishandling of the patient samples, or similar claims.
Product liability claims or product recalls, regardless of the ultimate outcome,
could require Celera Diagnostics to spend significant time and money in
litigation and to pay significant damages. Although Celera Diagnostics expects
to seek and maintain product liability insurance to cover claims relating to the
testing and use of diagnostic products, there can be no assurance that such
insurance will be available on commercially reasonable terms, if at all, or that
the amount of coverage obtained will be adequate to cover losses from any
particular claim.
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The diagnostics industry is intensely competitive and evolving.
There is intense competition among health care, biotechnology, and
diagnostic companies attempting to discover candidates for potential new
diagnostic products. These companies may:
o develop new diagnostic products in advance of Celera
Diagnostics;
o develop diagnostic products which are more effective or more
cost-effective than those developed by Celera Diagnostics;
o obtain regulatory approvals of their diagnostic products more
rapidly than Celera Diagnostics; or
o obtain patent protection or other intellectual property rights
that would limit Celera Diagnostics' ability to develop and
commercialize, or its customers' ability to use, Celera
Diagnostics' diagnostic products.
Celera Diagnostics competes with entities in the United States and
abroad that are engaged in the development and commercialization of products
that provide genetic information. They include:
o purveyors of genetic testing services, which are not subject
to the same clinical validation requirements as Celera
Diagnostics' products, and which do not require United States
Food and Drug Administration or other regulatory approval,
including Laboratory Corporation of America Holdings, Quest
Diagnostics Inc., and Specialty Laboratories, Inc.;
o manufacturers of analyte specific reagents and genotyping test
kits;
o purveyors of phenotyping assay services; and
o manufacturers and distributors of DNA probe-based diagnostic
systems.
Electricity shortages and earthquakes could disrupt operations in
California.
The headquarters and principal operations of Celera Diagnostics are
located in Alameda, California. In 2001, the State of California experienced a
statewide electricity shortage due to a variety of factors. Although some of the
factors causing this shortage have been eliminated or mitigated, there are
ongoing concerns about the availability of electricity in California,
particularly during peak usage periods. Blackouts in Alameda, even of modest
duration, could impair or cause a temporary suspension of Celera Diagnostics'
operations, including the manufacturing and shipment of new products. Power
disruptions of an extended duration or high frequency could have a material
adverse effect on operating results. In addition, Alameda is located near major
California earthquake faults. The ultimate impact of earthquakes on the Celera
Diagnostics, its significant suppliers, and the general infrastructure is
unknown, but operating results could be materially affected in the event of a
major earthquake.
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Risks Relating to a Capital Structure with Two Separate Classes of
Common Stock
Stockholders of the Company are stockholders of one company and,
therefore, financial effects on one group could adversely affect the
other.
Applied Biosystems and Celera Genomics are not separate legal entities.
As a result, stockholders will continue to be subject to all of the risks of an
investment in the Company, including Applied Biosystems and Celera Genomics. The
risks and uncertainties that may affect the operations, performance,
development, and results of the businesses of Applied Biosystems and Celera
Genomics are described above. The assets attributed to one group could be
subject to the liabilities of the other group, even if these liabilities arise
from lawsuits, contracts, or indebtedness that the Company attributes to the
other group. If the Company is unable to satisfy one group's liabilities out of
the assets attributed to it, the Company may be required to satisfy those
liabilities with assets attributed to the other group.
Financial effects from one group that affect the Company's consolidated
results of operations or financial condition could, if significant, affect the
results of operations or financial condition of the other group and the market
price of the common stock relating to the other group. In addition, net losses
of either group and dividends or distributions on, or repurchases of, either
class of common stock or repurchases of preferred stock will reduce the funds
the Company can pay as dividends on each class of common stock under Delaware
law. For these reasons, stockholders should read the consolidated financial
information with the financial information the Company provides for each group.
The market price of either class of the Company's common stock may not reflect
the separate performance of the group related to that common stock.
The market price of Applera Corporation - Applied Biosystems Group
Common Stock and Applera Corporation - Celera Genomics Group Common Stock may
not reflect the separate performance of the business of the group relating to
that class of common stock. The market price of either class of common stock
could simply reflect the performance of the Company as a whole, or the market
price of either class of common stock could move independently of the
performance of the business of either group. Investors may discount the value of
either class of common stock because it is part of a common enterprise rather
than a stand-alone company.
The market price of either class of the Company's common stock may be
affected by factors that do not affect traditional common stock.
o The complex nature of the terms of Applera Corporation -
Applied Biosystems Group Common Stock and Applera Corporation
- Celera Genomics Group Common Stock may adversely affect the
market price of either class of common stock. The complex
nature of the terms of the two classes of common stock, such
as the convertibility of Applera Corporation - Applied
Biosystems Group Common Stock into Applera Corporation -
Celera Genomics Group Common Stock, or vice versa, and the
potential difficulties investors may have understanding these
terms, may adversely affect the market price of either class
of common stock.
o The market price of Applera Corporation - Applied Biosystems
Group Common Stock or Applera Corporation - Celera Genomics
Group Common Stock may be adversely affected by the fact that
holders have limited legal interests in the group relating to
the class of common stock held as a separate legal entity. For
example,
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as described in greater detail in the subsequent risk factors,
holders of either class of common stock generally do not have
separate class voting rights with respect to significant
matters affecting either group. In addition, upon a
liquidation or dissolution of the Company, holders of either
class of common stock will not have specific rights to the
assets of the group relating to the class of common stock held
and will not be entitled to receive proceeds that are
proportional to the relative performance of that group.
o The market price of Applera Corporation - Applied Biosystems
Group Common Stock or Applera Corporation - Celera Genomics
Group Common Stock may be adversely affected by events
involving the group relating to the other class of common
stock or the performance of the class of common stock relating
to that group. Events, such as earnings announcements or other
developments concerning one group that the market does not
view favorably and which thus adversely affect the market
price of the class of common stock relating to that group, may
adversely affect the market price of the class of common stock
relating to the other group. Because both classes of common
stock are common stock of the Company, an adverse market
reaction to one class of common stock may, by association,
cause an adverse reaction to the other class of common stock.
This reaction may occur even if the triggering event was not
material to the Company as a whole.
Limits exist on the voting power of group common stock.
o Applera Corporation - Celera Genomics Group Common Stock May
Not Have Any Influence on the Outcome of Stockholder Voting.
Applera Corporation - Applied Biosystems Group Common Stock
currently has a substantial majority of the voting power of
the Company's common stock and had approximately 83.3% of the
voting power as of August 28, 2002, the record date for the
Company's 2002 annual meeting of stockholders. Except in
limited circumstances where there is separate class voting,
the relative voting power of the two classes of common stock
fluctuates based on their relative market values. Therefore,
except in cases of separate class voting, either class of
common stock that is entitled to more than the number of votes
required to approve any stockholder action could control the
outcome of the vote even if the matter involves a divergence
or conflict of the interests of the holders of Applera
Corporation - Applied Group Biosystems Common Stock and
Applera Corporation - Celera Genomics Group Common Stock.
These matters may include mergers and other extraordinary
transactions.
o A class of group common stock with less than majority voting
power can block action if a class vote is required. If
Delaware law, stock exchange rules, or the Company's Board of
Directors requires a separate vote on a matter by the holders
of either Applera Corporation - Applied Biosystems Group
Common Stock or Applera Corporation - Celera Genomics Group
Common Stock, those holders could prevent approval of the
matter even if the holders of a majority of the total number
of votes cast or entitled to be cast, voting together as a
class, were to vote in favor of it. As a result, in cases
where holders of Applera Corporation - Applied Biosystems
Group Common Stock or Applera Corporation - Celera Genomics
Group Common Stock vote as separate classes on a proposal, the
affirmative vote of shares representing a majority of one
class of common stock will not prevent the holders of the
other class of common stock from defeating the proposal.
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o Holders of only one class of common stock cannot ensure that
their voting power will be sufficient to protect their
interests. Since the relative voting power per share of
Applera Corporation - Applied Biosystems Group Common Stock
and Applera Corporation - Celera Genomics Group Common Stock
will fluctuate based on the market values of the two classes
of common stock, the relative voting power of a class of
common stock could decrease. As a result, holders of shares of
only one of the two classes of common stock cannot ensure that
their voting power will be sufficient to protect their
interests.
o Stockholders of either class of common stock will not have
some of the stockholder rights traditionally associated with
common stock. Neither Applied Biosystems nor Celera Genomics
will have a separate board of directors to represent solely
the interests of either class of common stock as holders of
that class. Consequently, there will be no board of directors
that owes any separate duties to holders of one class of
common stock as holders of that class. The Company's Board of
Directors will act in accordance with its good faith business
judgment of the best interests of the Company, taking into
consideration the interests of all common stockholders
regardless of class or series, which may be detrimental to
holders of one class of common stock has holders of that
class.
Stockholders may not have any remedies for breach of fiduciary duties
if any action by directors or officers has a disadvantageous effect on
either class of common stock.
Stockholders may not have any remedies if any action or decision of the
Company's Board of Directors or officers has a disadvantageous effect on Applera
Corporation - Applied Biosystems Group Common Stock or Applera Corporation -
Celera Genomics Group Common Stock compared to the other class of common stock.
Cases in Delaware involving tracking stocks have established that decisions by
directors or officers involving differing treatment of tracking stocks are
judged under the principle known as the "business judgment rule" unless
self-interest is shown.
In addition, principles of Delaware law established in cases involving
differing treatment of two classes of common stock or two groups of holders of
the same class of common stock provide that a board of directors owes an equal
duty to all stockholders regardless of class or series. Absent abuse of
discretion, a good faith business decision made by a disinterested and
adequately informed Board of Directors, Board of Directors' committee, or
officer of the Company with respect to any matter having different effects on
holders of Applera Corporation - Applied Biosystems Group Common Stock and
holders of Applera Corporation - Celera Genomics Group Common Stock would be a
defense to any challenge to the determination made by or on behalf of the
holders of either class of common stock.
Stock ownership could cause directors and officers to favor one group
over the other.
As a policy, the Company's Board of Directors periodically monitors the
ownership of shares of Applera Corporation - Applied Biosystems Group Common
Stock and Applera Corporation - Celera Genomics Group Common Stock by the
Company's directors and senior officers as well as their option holdings and
other benefits so that their interests are not
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misaligned with the two classes of common stock and with their duty to act in
the best interests of the Company and its stockholders as a whole. However,
because the actual stock market value of their interests in Applera Corporation
- - Applied Biosystems Group Common Stock and Applera Corporation - Celera
Genomics Group Common Stock could vary significantly, it is possible that they
could favor one group over the other as a result of their common stock holdings,
options and other benefits. As of August 26, 2002, the Company's directors and
senior officers held shares of Applera Corporation - Applied Biosystems Group
Common Stock and Applera Corporation - Celera Genomics Group Common Stock
representing approximately equal percentages of the total shares outstanding of
Applera Corporation - Applied Biosystems Group Common Stock and Applera
Corporation - Celera Genomics Group Common Stock. The stock market value of
these shares will vary with fluctuations in the market price of Applera
Corporation - Applied Biosystems Group Common Stock and Applera Corporation -
Celera Genomics Group Common Stock. However, the market capitalization of
Applied Biosystems is substantially greater than that of Celera Genomics and,
therefore, the market value of Applera Corporation - Applied Biosystems Group
Common Stock held by the Company's directors and senior officers was
significantly higher than the market value of Applera Corporation - Celera
Genomics Group Common Stock held by them on that date.
Numerous potential conflicts of interest exist between the classes of
common stock that may be difficult to resolve by the Company's Board of
Directors or that may be resolved adversely to one of the classes.
o Allocation of corporate opportunities could favor one group
over the other. The Company's Board of Directors may be
required to allocate corporate opportunities between Applied
Biosystems and Celera Genomics. In some cases, the Company's
directors could determine that a corporate opportunity, such
as a business that the Company is acquiring or a new business,
should be shared by the groups or be allocated to one group
over the other. Any decisions could favor one group to the
detriment of the other.
o Applied Biosystems and Celera Genomics may compete with each
other to the detriment of their businesses. The existence of
two separate classes of common stock will not prevent Applied
Biosystems and Celera Genomics from competing with each other.
Any competition between Applied Biosystems and Celera Genomics
could be detrimental to the businesses of either or both of
the groups. Under a Board of Directors' policy, the groups
will generally not engage in the principal businesses of the
other, except for joint transactions with each other. However,
the Company's Chief Executive Officer or Board of Directors
will permit indirect competition between the groups, such as
one group doing business with a competitor of the other group,
based on his or its good faith business judgment that the
competition is in the best interests of the Company and all of
the Company's stockholders as a whole. In addition, the groups
may compete in a business that is not a principal business of
the other group.
o The Company's Board of Directors may pay more or less
dividends on group common stock than if that group were a
separate company. Subject to the limitations referred to
below, the Company's Board of Directors has the authority to
declare and pay dividends on Applera Corporation - Applied
Biosystems Group Common Stock and Applera Corporation - Celera
Genomics Group Common Stock in any amount and could, in its
sole discretion, declare and pay dividends exclusively
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on Applera Corporation - Applied Biosystems Group Common
Stock, exclusively on Applera Corporation - Celera Genomics
Group Common Stock, or on both, in equal or unequal amounts.
The Company's Board of Directors is not required to consider
the amount of dividends previously declared on each class, the
respective voting or liquidation rights of each class, or any
other factor. The performance of one group may cause the
Company's Board of Directors to pay more or less dividends on
the common stock relating to the other group than if that
other group were a stand-alone company. In addition, Delaware
law and the Company's certificate of incorporation impose
limitations on the amount of dividends that may be paid on
each class of common stock.
o Proceeds of mergers or consolidations may be allocated
unfavorably. The Company's Board of Directors will determine
how consideration to be received by holders of common stock in
connection with a merger or consolidation involving the
Company is to be allocated among holders of each class of
common stock. This percentage may be materially more or less
than that which might have been allocated to the holders had
the Company's Board of Directors chosen a different method of
allocation.
o Holders of either class of common stock may be adversely
affected by a conversion of group common stock. The Company's
Board of Directors could, in its sole discretion and without
stockholder approval, determine to convert shares of Applera
Corporation - Applied Biosystems Group Common Stock into
shares of Applera Corporation - Celera Genomics Group Common
Stock, or vice versa, at any time, including when either or
both classes of common stock may be considered to be
overvalued or undervalued. If the Company's Board of Directors
chose to issue Applera Corporation - Celera Genomics Group
Common Stock in exchange for Applera Corporation - Applied
Biosystems Group Common Stock, or vice versa, the conversion
would dilute the interests in the Company of the holders of
the class of common stock being issued in the conversion. If
the Company's Board of Directors were to choose to issue
Applera Corporation - Celera Genomics Group Common Stock in
exchange for Applera Corporation - Applied Biosystems Group
Common Stock, or vice versa, the conversion could give holders
of shares of the class of common stock being converted a
greater or lesser premium than any premium that was paid or
might be paid by a third-party buyer of all or substantially
all of the assets of the group whose stock is converted.
o Cash proceeds of newly issued Applera Corporation - Celera
Genomics Group Common Stock in the future could be allocated
to Applied Biosystems. If and to the extent Applied Biosystems
holds "Celera Genomics Designated Shares" at the time of any
future sale of Applera Corporation - Celera Genomics Group
Common Stock, the Company's Board of Directors could allocate
some or all of the proceeds of that sale to Applied Biosystems
in consideration of a reduction in the number of these shares.
Celera Genomics Designated Shares are a type of authorized
shares of Applera Corporation - Celera Genomics Group Common
Stock. Any decision could favor one group over the other
group. For example, the decision to allocate the proceeds of
that sale to Applied Biosystems could adversely affect Celera
Genomics' ability to obtain funds to finance its growth
strategies. Applied Biosystems does not hold any Celera
Genomics Designated Shares as of the date of this Annual
Report on Form 10-K. Celera Genomics Designated Shares could
be issued in the future if the
-66-
Company's Board of Directors determines that Celera Genomics
requires additional capital to finance its business and that
Applied Biosystems should supply that capital.
The Company's Board of Directors may change its management and
allocation policies without stockholder approval to the detriment of
either group.
The Company's Board of Directors may modify or rescind the Company's
policies with respect to the allocation of corporate overhead, taxes, debt,
interest, and other matters, or may adopt additional policies, in its sole
discretion without stockholder approval. A decision to modify or rescind these
policies, or adopt additional policies, could have different effects on holders
of Applera Corporation - Applied Biosystems Group Common Stock and holders of
Applera Corporation - Celera Genomics Group Common Stock or could result in a
benefit or detriment to one class of stockholders compared to the other class.
The Company's Board of Directors will make any decision in accordance with its
good faith business judgment that the decision is in the best interests of the
Company and all of its stockholders as a whole.
Either Applied Biosystems or Celera Genomics may finance the other
group on terms unfavorable to either group.
From time to time, the Company anticipates that it will transfer cash
and other property between groups to finance their business activities. When
this occurs, the group providing the financing will be subject to the risks
relating to the group receiving the financing. The Company will account for
those transfers in one of the following ways:
o as a reallocation of pooled debt or preferred stock;
o as a short-term or long-term loan between groups or as a
repayment of a previous borrowing;
o as an increase or decrease in Celera Genomics Designated
Shares; or
o as a sale of assets between groups.
The Company's Board of Directors has not adopted specific criteria for
determining when it will account for transfer of cash or other property as a
reallocation of pooled debt or preferred stock, a loan or repayment, an increase
or decrease in Celera Genomics Designated Shares, or a sale of assets. These
determinations, including the terms of any transactions accounted for as debt,
may be unfavorable to either the group transferring or receiving the cash or
other property. The Company's Board of Directors expects to make these
determinations, either in specific instances or by setting generally applicable
policies, after considering the financing requirements and objectives of the
receiving group, the investment objectives of the transferring group, and the
availability, cost, and time associated with alternative financing sources,
prevailing interest rates, and general economic conditions.
The Company cannot assure stockholders that any terms that it fixes for
debt will approximate those that could have been obtained by the borrowing group
if it were a stand-alone company.
-67-
Celera Genomics could incur a higher tax liability than if it were a
stand-alone taxpayer.
The Company's tax allocation policy provides that some tax benefits
that cannot be used by the group generating those benefits but can be used on a
consolidated basis are to be transferred, without reimbursement, to the group
that can use the benefits. Any tax benefits that are transferred from Celera
Genomics to Applied Biosystems will not be carried forward to reduce Celera
Genomics' future tax liability. As a result of this policy, Celera Genomics
generated tax benefits of $32.2 million for the Company's 2001 fiscal year and
$19.0 million for the Company's 2002 fiscal year that were utilized by Applied
Biosystems with no reimbursement to Celera Genomics. This and future use by
Applied Biosystems, without reimbursement, of tax benefits generated by Celera
Genomics will result in Celera Genomics paying a greater portion of the total
corporate tax liability than would have been the case if Celera Genomics were a
stand-alone taxpayer.
Holders of group common stock may receive less consideration upon a
sale of assets than if the group were a separate company.
The Company's certificate of incorporation provides that if a
disposition of all or substantially all of the assets of either group occurs,
the Company must, subject to certain exceptions:
o distribute to holders of the class of common stock relating to
that group an amount equal to the net proceeds of such
disposition; or
o convert at a 10% premium the common stock relating to that
group into shares of the class of common stock relating to the
other group.
If the group subject to the disposition were a separate, independent
company and its shares were acquired by another person, some of the costs of
that disposition, including corporate level taxes, might not be payable in
connection with that acquisition. As a result, if the group subject to the
disposition were a stand-alone company, stockholders of that group might receive
a greater amount than the net proceeds that would be received by those
stockholders if the assets of that group were sold and the proceeds distributed
to those stockholders. In addition, the Company cannot assure stockholders that
the net proceeds per share of the common stock relating to that group will be
equal to or more than the market value per share of that common stock prior to
or after announcement of a disposition.
The Company's capital structure and variable vote per share may
discourage acquisitions of a group or a class of common stock.
A potential acquirer could acquire control of the Company by acquiring
shares of common stock having a majority of the voting power of all shares of
common stock outstanding. This majority could be obtained by acquiring a
sufficient number of shares of both classes of common stock or, if one class of
common stock has a majority of the voting power, only shares of that class since
the relative aggregate voting power of the two classes of common stock
fluctuates based on their relative aggregate market values. Currently, Applera
Corporation - Applied Biosystems Group Common Stock has a substantial majority
of the voting power. As a
-68-
result, it might be possible for an acquirer to obtain control by purchasing
only shares of Applera Corporation - Applied Biosystems Group Common Stock.
Decisions by the Company's Board of Directors and officers that affect
market values could adversely affect voting and conversion rights.
The relative voting power per share of each class of common stock and
the number of shares of one class of common stock issuable upon the conversion
of the other class of common stock will vary depending upon the relative market
values of Applera Corporation - Applied Biosystems Group Common Stock and
Applera Corporation - Celera Genomics Group Common Stock. The market value of
either or both classes of common stock could be adversely affected by market
reaction to decisions by the Company's Board of Directors or management that
investors perceive as affecting differently one class of common stock compared
to the other. These decisions could involve changes to the Company's management
and allocation policies, transfers of assets between groups, allocations of
corporate opportunities and financing resources between groups, and changes in
dividend policies.
Provisions governing common stock could discourage a change of control
and the payment of a premium for stockholders' shares.
The Company's stockholder rights plan could prevent stockholders from
profiting from an increase in the market value of their shares as a result of a
change in control of the Company by delaying or preventing a change in control.
The existence of two classes of common stock could also present complexities and
may pose obstacles, financial and otherwise, to an acquiring person. In
addition, provisions of Delaware law and the Company's certificate of
incorporation and bylaws may also deter hostile takeover attempts.
Legislative proposals could have adverse tax consequences for the
Company and holders of Applera Corporation - Celera Genomics Group
Common Stock and Applera Corporation - Applied Biosystems Group Common
Stock.
The Clinton Administration Budget Proposals in 1999 and 2000 proposed
legislation that would have adversely affected holders of tracking stock such as
Applera Corporation - Celera Genomics Group Common Stock and Applera Corporation
- - Applied Biosystems Group Common Stock. The 1999 proposal would have required
corporate-level gain recognition on the issuance of tracking stock, while the
2000 proposal would have required that the stockholders of the issuing
corporation be taxed upon the receipt of tracking stock in specified
circumstances. Although Congress did not act on either proposal and the 2001 and
2002 Bush Administration Budget Proposals do not contain a similar provision, it
is impossible to predict whether any proposals relating to tracking stock will
be made in the future, and to what extent Congress would act upon any proposals.
The Company may convert Applera Corporation - Celera Genomics Group
Common Stock or Applera Corporation - Applied Biosystems Group Common Stock into
shares of the other class without any premium if, based on the legal opinion of
its tax counsel, it is more likely than not as a result of the enactment of
legislative changes or administrative proposals or changes that the Company or
its stockholders will be subject to tax upon issuance of Applera Corporation -
Celera Genomics Group Common Stock or Applera Corporation - Applied Biosystems
Group Common Stock or that the stock will not be treated as stock of the
Company.
-69-
Item 6. SELECTED FINANCIAL DATA
The Company incorporates herein by reference pages 9 and 10 of the
Company's Annual Report to Stockholders for the fiscal year ended June 30, 2002.
Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The Company incorporates herein by reference pages 11-45 of the
Company's Annual Report to Stockholders for the fiscal year ended June 30, 2002.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
The Company incorporates herein by reference page 30 of the Company's
Annual Report to Stockholders for the fiscal year ended June 30, 2002.
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The following financial statements and the supplementary financial
information included in the Company's Annual Report to Stockholders for the
fiscal year ended June 30, 2002, are incorporated herein by reference: the
Consolidated Financial Statements and the report thereon of
PricewaterhouseCoopers LLP dated July 25, 2002, on pages 46-84 of said Annual
Report, including Note 11, page 69, which contains unaudited quarterly financial
information.
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON
ACCOUNTING AND FINANCIAL DISCLOSURE
Not applicable.
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PART III
Item 10. DIRECTORS AND EXECUTIVE OFFICERS
OF THE REGISTRANT
Identification and Business Experience of Directors
With respect to the identification and business experience of the
Company's directors and persons nominated to become directors, the Company
incorporates herein by reference pages 3 and 4 of the Company's Proxy Statement
dated September 4, 2002, in connection with its Annual Meeting of Stockholders
to be held on October 17, 2002.
Identification and Business Experience of Executive Officers
The following is a list of the Company's executive officers, their
ages, and their corporate offices with the Company and other positions held as
of September 27, 2002.
Name Age Present Corporate Office (Year First Elected), and Other Positions Held
- ---- --- -----------------------------------------------------------------------
Ugo D. DeBlasi................40 Assistant Controller (1999), and Vice President, Finance, Celera
Genomics Group
David S. Block................42 Vice President (2002), and Senior Vice President and Chief Operating
Officer, Therapeutics, of the Celera Genomics Group
Robert F.G. Booth.............48 Vice President (2002), and Senior Vice President, Research and
Development, Celera Genomics Group
Patrick T. Carroll............50 Vice President (2002), and Senior Vice President, Worldwide Sales,
Service and Support, Applied Biosystems Group
Michael W. Hunkapiller........53 Senior Vice President, and President, Applied Biosystems Group (1997)
Vikram Jog....................46 Corporate Controller (1999), and Vice President, Finance, Celera
Diagnostics
Robert C. Jones...............47 Vice President (2001), and Senior Vice President, R&D, Applied
Biosystems Group
Barbara J. Kerr...............56 Vice President, Human Resources (2000)
Sandeep Nayyar................43 Assistant Controller (2002), and Vice President, Finance, Applied
Biosystems Group
Kathy P. Ordonez..............52 Senior Vice President, and President, Celera Genomics Group and Celera
Diagnostics (2002)
Robert P. Ragusa..............42 Vice President (2001), and Senior Vice President, Global Operations,
Applied Biosystems Group
William B. Sawch..............48 Senior Vice President (1997) and General Counsel (1993)
Deborah A. Smeltzer...........48 Vice President (2002), and Vice President, Knowledge Business, Applied
Biosystems Group
Tony L. White.................56 Chairman, President, and Chief Executive Officer (1995)
Dennis L. Winger..............54 Senior Vice President and Chief Financial Officer (1997)
Each of the foregoing named officers was either elected at the last
organizational meeting of the Company's Board of Directors, or elected by the
Board since that date. The term of each officer will expire on October 17, 2002,
the date of the next scheduled organizational meeting of the Board of Directors,
unless renewed for another year.
Each executive officer of the Company has been employed by the Company
or a subsidiary in one or more executive or managerial capacities for at least
the past five years, with the exception of Dr. Block, Dr. Booth, Mr. Jog, Ms.
Kerr, Mr. Nayyar, Ms. Ordonez, Ms. Smeltzer, and Mr. Winger. Mr. DeBlasi
previously served as Controller of the Company, from November 1996 to August
1999. Dr. Hunkapiller previously served as Vice President of the Company from
September 1994 to October 1997. Mr. Sawch previously served as Vice President,
General Counsel, and Secretary of the Company from July 1993 to October 1997,
and as Senior Vice President, General Counsel, and Secretary of the Company from
October 1997 to March 2000.
-71-
Dr. Block was elected Vice President of the Company on April 5, 2002.
Prior to his employment by the Company in January 2002, Dr. Block was employed
by DuPont Pharmaceuticals Company, an international pharmaceutical company,
where he held a series of executive positions over 12 years, including most
recently Executive Vice President of International Operations throughout 2001.
Prior to that he was the Senior Vice President, Business Development and
Strategic Planning from 1999 to 2001 and Vice President, Product Planning and
Acquisition from 1997 to 1999.
Dr. Booth was elected Vice President of the Company on August 15, 2002.
Prior to his employment by the Company in August 2002, Dr. Booth was employed
by Hoffmann-La Roche, a leading international healthcare company, where he held
a series of executive positions over 13 years, including most recently as Senior
Vice President responsible for all research and early development of
inflammatory, viral, respiratory, and bone disease products from January 1996 to
August 2002.
Mr. Jog was elected Controller of the Company on August 19, 1999. Prior
to his employment by the Company in August 1999, Mr. Jog served as Vice
President and Controller of Hercules Incorporated, a manufacturer of chemicals,
for seven years.
Ms. Kerr was elected Vice President, Human Resources of the Company on
September 5, 2000. Prior to her employment by the Company in September 2000, Ms.
Kerr served as a principal of Quantic, Inc., a human resources and compensation
consulting firm. Prior to that, Ms. Kerr was employed by Chiron Corporation,
which conducts research and development in the fields of biological proteins,
gene therapy, and combinatorial chemistry, where she was Vice President, Human
Resources from 1990 to 1997.
Mr. Nayyar was elected Assistant Controller of the Company on April 5,
2002. Prior to his employment by the Company in October 2001, Mr. Nayyar was
employed by Quantum Corporation, a data storage company, where he was Vice
President of Finance for the Hard Disk Drive Group from 2000 to 2001, Vice
President, Finance for the High-end Storage Division from 1998 to 2000, Director
of Finance for the Corporate Finance Group from 1997 to 1998, and Controller for
the High Capacity Storage Group from 1994 to 1997.
Ms. Ordonez was elected Vice President of the Company on December 1,
2000, and was elected Senior Vice President, and President Celera Genomics
Group and Celera Diagnostics on August 15, 2002. Prior to her employment by the
Company in December 2000, Ms. Ordonez was employed by Hoffmann-La Roche, a
leading international healthcare company, where she was President and Chief
Executive Officer of Roche Molecular Systems from 1991 to 2000.
Ms. Smeltzer was elected Assistant Controller of the Company on
November 18, 1999, and was elected Vice President of the Company on April 5,
2002. Prior to her employment by the Company in November 1999, Ms. Smeltzer
served as Chief Financial Officer and Vice President of Genset, SA, a global
genomics company from May 1996 to November 1999, and she was a general partner
of Grotech Capital Group, Inc. from 1988 to 1996.
Mr. Winger was elected Senior Vice President and Chief Financial
Officer of the Company on October 16, 1997. Prior to his employment by the
Company in September 1997, Mr. Winger was employed by Chiron Corporation, which
conducts research and development in the fields of biological proteins, gene
therapy, and combinatorial chemistry, where he was Senior Vice President,
Finance and Administration, and Chief Financial Officer from 1989 to 1997.
-72-
Identification of Certain Significant Employees
Not applicable.
Family Relationships
To the best of the Company's knowledge and belief, there is no family
relationship between any of the Company's directors, executive officers, or
persons nominated or chosen by the Company to become a director or an executive
officer.
Involvement in Certain Legal Proceedings
To the best of the Company's knowledge and belief, none of the
Company's directors, persons nominated to become directors, or executive
officers has been involved in any proceedings during the past five years that
are material to an evaluation of the ability or integrity of such persons to be
directors or executive officers of the Company.
Section 16(a) Beneficial Ownership Reporting Compliance
Information concerning compliance with Section 16(a) of the Securities
Exchange Act of 1934 is incorporated herein by reference to page 10 of the
Company's Proxy Statement dated September 4, 2002, in connection with its Annual
Meeting of Stockholders to be held on October 17, 2002.
Item 11. EXECUTIVE COMPENSATION
The Company incorporates herein by reference pages 11-21 of the
Company's Proxy Statement dated September 4, 2002, in connection with its Annual
Meeting of Stockholders to be held on October 17, 2002.
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIALOWNERS AND
MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Securities Authorized for Issuance Under Equity Compensation Plans
Information regarding securities authorized for issuance under equity
compensation plans as of the end of the 2002 fiscal year is incorporated herein
by reference to pages 35-37 of the Company's Proxy Statement dated September 4,
2002, in connection with its Annual Meeting of Stockholders to be held on
October 17, 2002.
Security Ownership of Certain Beneficial Owners
Information concerning the security ownership of certain beneficial
owners is incorporated herein by reference to pages 8-10 of the Company's Proxy
Statement dated September 4, 2002, in connection with its Annual Meeting of
Stockholders to be held on October 17, 2002.
-73-
Security Ownership of Management
Information concerning the security ownership of management is
incorporated herein by reference to pages 8-10 of the Company's Proxy Statement
dated September 4, 2002, in connection with its Annual Meeting of Stockholders
to be held on October 17, 2002.
Changes in Control
The Company knows of no arrangements, including any pledge by any
person of securities of the Company, the operation of which may at a subsequent
date result in a change in control of the Company.
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Information concerning certain relationships and related transactions
is incorporated herein by reference to pages 21 and 22 of the Company's Proxy
Statement dated September 4, 2002, in connection with its Annual Meeting of
Stockholders to be held on October 17, 2002.
Item 14. CONTROLS AND PROCEDURES
There have not been any significant changes in the Company's internal
controls or in other factors that could significantly affect these controls
during the 90 days prior to the filing of this Annual Report on Form 10-K.
-74-
PART IV
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND
REPORTS ON FORM 8-K
(a) 1. Financial Statements
The following financial statements, together with the report thereon of
PricewaterhouseCoopers LLP dated July 25, 2002, appearing in the Company's
Annual Report to Stockholders for the fiscal year ended June 30, 2002, are
incorporated by reference in this Annual Report on Form 10-K. With the exception
of the aforementioned information and that which is specifically incorporated in
Parts I and II, the Annual Report to Stockholders for the fiscal year ended June
30, 2002, is not to be deemed filed as part of this Annual Report on Form 10-K.
Annual Report
Page No.
-----------------
Consolidated Statements of Operations
Fiscal years 2000, 2001, and 2002 46
Consolidated Statements of Financial Position
At June 30, 2001 and 2002 47
Consolidated Statements of Cash Flows
Fiscal years 2000, 2001, and 2002 48
Consolidated Statements of Stockholders' Equity
Fiscal years 2000, 2001, and 2002 49
Notes to Consolidated Financial Statements 50-83
Report of Management 84
Report of Independent Accountants 84
-75-
(a) 2. Financial Statement Schedule
The following additional financial data should be read in conjunction with the
consolidated financial statements in said Annual Report to Stockholders for the
fiscal year ended June 30, 2002. Schedules not included with this additional
financial data have been omitted because they are not applicable or the required
information is shown in the consolidated financial statements or notes thereto.
10-K Page No.
-------------
Report of Independent Accountants on Financial Statement
Schedule................................................. 83
Schedule II - Valuation and Qualifying Accounts and
Reserves................................................. 84
(a) 3. Exhibits
Exhibit
No.
- ---------
2.1 Agreement and Plan of Merger dated March 10, 1999, among The
Perkin-Elmer Corporation, a New York corporation, The Perkin-Elmer
Corporation, a Delaware corporation, and PE Merger Corp., a New York
corporation (incorporated by reference to Exhibit 2.1 to the
Company's Registration Statement on Form S-4 (No. 333-67797)).
2.2 Agreement and Plan of Merger dated as of June 12, 2001, among Applera
Corporation, a Delaware corporation, Angel Acquisition Sub, Inc., a
Delaware corporation, and Axys Pharmaceuticals, Inc., a Delaware
corporation (incorporated by reference to Exhibit 2.1 to the
Company's Current Report on Form 8-K dated June 12, 2001 (Commission
file number 1-4389)).
3.1.1 Restated Certificate of Incorporation of the Company (incorporated by
reference to Exhibit 3(i) to the Company's Quarterly Report on Form
10-Q for the fiscal quarter ended December 31, 2000 (Commission file
number 1-4389)).
3.1.2 Certificate of Designations of Series A Participating Junior
Preferred Stock and Series B Participating Junior Preferred Stock
(incorporated by reference to Exhibit A to Exhibit 4.1 to the
Company's Registration Statement on Form S-4 (No. 333-67797)).
3.2 By-laws of the Company (incorporated by reference to Exhibit 3.2 to
the Company's Registration Statement on Form S-4 (No. 333-67797)).
4.1 Stockholder Protection Rights Agreement between the Company and
BankBoston, N.A. (incorporated by reference to Exhibit 4.1 to the
Company's Registration Statement on Form S-4 (No. 333-67797)).
4.2 Amendment to Rights Agreement among BankBoston, N.A., EquiServe Trust
Company, N.A., and the Company.
4.3 Credit Agreement dated as of April 20, 2000, among The Perkin-Elmer
Corporation, the Company, the lenders party thereto, Salomon Smith
Barney Inc., Wachovia Bank, N.A., The Chase Manhattan Bank, and
Citibank, N.A. (incorporated by reference to Exhibit 4(2) to Annual
Report on Form 10-K of the Company for the fiscal year ended June 30,
2000 (Commission file number 1-4389)).
4.4 Indenture dated as of September 22, 2000, between U.S. Bank Trust
National Association and Axys Pharmaceuticals, Inc. (incorporated by
reference to Exhibit 4.1 to Current Report on Form 8-K of Axys
Pharmaceuticals, Inc. filed September 28, 2000 (Commission file
number 0-22788)).
4.5 First Supplemental Indenture dated as of September 22, 2000, between
U.S. Bank Trust National Association and Axys Pharmaceuticals, Inc.
(incorporated by reference to Exhibit 4.2 to Current Report on Form
8-K of Axys Pharmaceuticals, Inc. filed September 28, 2000
(Commission file number 0-22788)).
-76-
10.1 The Perkin-Elmer Corporation 1988 Stock Incentive Plan for Key
Employees (incorporated by reference to Exhibit 10(4) to Annual
Report on Form 10-K of the Company for the fiscal year ended July 31,
1988 (Commission file number 1-4389)).*
10.2 The Perkin-Elmer Corporation 1993 Stock Incentive Plan for Key
Employees (incorporated by reference to Exhibit 99 to the Company's
Registration Statement on Form S-8 (No. 33-50847)).*
10.3 The Perkin-Elmer Corporation 1996 Stock Incentive Plan (incorporated
by reference to Exhibit 99 to the Company's Registration Statement on
Form S-8 (No. 333-15189)).*
10.4 The Perkin-Elmer Corporation 1996 Employee Stock Purchase Plan, as
amended October 15, 1998 (incorporated by reference to Exhibit A to
the Company's Proxy Statement for its 1998 Annual Meeting of
Stockholders (Commission file number 1-4389)).*
10.5 The Perkin-Elmer Corporation 1997 Stock Incentive Plan (incorporated
by reference to Exhibit 99 to the Company's Registration Statement on
Form S-8 (No. 333-38713)).*
10.6 The Perkin-Elmer Corporation 1998 Stock Incentive Plan (incorporated
by reference to Exhibit B to the Company's Proxy Statement for its
1998 Annual Meeting of Stockholders (Commission file number
1-4389)).*
10.7 Applera Corporation 1999 Employee Stock Purchase Plan (incorporated
by reference to Exhibit A to the Company's Proxy Statement for its
1999 Annual Meeting of Stockholders (Commission file number
1-4389)).*
10.8 Applera Corporation/Applied Biosystems Group 1999 Stock Incentive
Plan, as amended October 18, 2001 (incorporated by reference to
Appendix A to Schedule 14A, filed September 24, 2001, containing the
Company's Proxy Statement for its 2001 Annual Meeting of Stockholders
(Commission file number 1-4389)).*
10.9 Applera Corporation/Celera Genomics Group 1999 Stock Incentive Plan,
as amended October 18, 2001 (incorporated by reference to Appendix B
to Schedule 14A, filed September 24, 2001, containing the Company's
Proxy Statement for its 2001 Annual Meeting of Stockholders
(Commission file number 1-4389)).*
10.10 The Perkin-Elmer Corporation Supplemental Retirement Plan effective
as of August 1, 1979, as amended through October 1, 1996
(incorporated by reference to Exhibit 10(22) to Annual Report on Form
10-K of the Company for the fiscal year ended June 30, 2000
(Commission file number 1-4389)).*
10.11 The Excess Benefit Plan of The Perkin-Elmer Corporation dated August
1, 1984, as amended through August 17, 2000 (incorporated by
reference to Exhibit 10(23) to Annual Report on Form 10-K of the
Company for the fiscal year ended June 30, 2000 (Commission file
number 1-4389)).*
10.12 Third Amendment to The Excess Benefit Plan of The Perkin-Elmer
Corporation effective January 1, 2001 (incorporated by reference to
Exhibit 10.25 to Annual Report on Form 10-K of the Company for the
fiscal year ended June 30, 2001 (Commission file number 1-4389)). *
10.13 Fourth Amendment to The Excess Benefit Plan of The Perkin-Elmer
Corporation effective October 1, 2001.*
10.14 1993 Director Stock Purchase and Deferred Compensation Plan, as
amended through March 17, 2000 (incorporated by reference to Exhibit
10.1 to Quarterly Report on Form 10-Q of the Company for the quarter
ended March 31, 2000 (Commission file number 1-4389)).*
10.15 Applera Corporation Performance Unit Bonus Plan, as amended through
August 16, 2001 (incorporated by reference to Exhibit 10.1 to
Quarterly Report on Form 10-Q of the Company for the quarter ended
December 31, 2001 (Commission file number 1-4389)).*
10.16 The Estate Enhancement Plan of The Perkin-Elmer Corporation
(incorporated by reference to Exhibit 10(22) to Annual Report on Form
10-K of the Company for the fiscal year ended June 30, 1997
(Commission file number 1-4389)).*
10.17 Applera Corporation Deferred Compensation Plan, as amended and
restated effective as of January 1, 2002 (incorporated by reference
to Exhibit 10.2 to Quarterly Report on Form 10-Q of the Company for
the quarter ended December 31, 2001 (Commission file number
1-4389)).*
10.18 Applied Biosystems, Inc. 1992 Stock Option Plan (incorporated by
reference to Exhibit 28(a) to the Company's Registration Statement on
Form S-8 (No. 33-58778)).*
10.19 PerSeptive Biosystems, Inc. 1992 Stock Plan, as amended January 20,
1997 (incorporated by reference to Exhibit 4.1 to the Quarterly
Report on Form 10-Q of PerSeptive Biosystems, Inc. for the fiscal
quarter ended March 29, 1997 (Commission file No. 0-20032)).*
10.20 PerSeptive Biosystems, Inc. 1997 Non-Qualified Stock Option Plan, as
amended August 21, 1997 (incorporated by reference to Exhibit 4.1 to
the Registration Statement on Form S-8 of PerSeptive Biosystems, Inc.
(No. 333-38989)).*
-77-
10.21 Molecular Informatics, Inc. 1997 Equity Ownership Plan (incorporated
by reference to Exhibit 99 to the Company's Registration Statement on
Form S-8 (No. 333-42683)).*
10.22 Paracel, Inc. Stock Option Plan.*
10.23 Axys Pharmaceuticals, Inc. 1989 Stock Plan (incorporated by
reference to Exhibit 10.2 to Annual Report on Form 10-K of Axys
Pharmaceuticals, Inc. for the fiscal year ended December 31, 1996
(Commission file number 0-22788)).*
10.24 Axys Pharmaceuticals, Inc. 1997 Equity Incentive Plan (incorporated
by reference to Exhibit 10.30 to the Company's Registration Statement
on Form S-8 (No. 333-73980)).*
10.25 Axys Pharmaceuticals, Inc. 1997 Non-Officer Equity Incentive Plan
(incorporated by reference to Exhibit 10.31 to the Company's
Registration Statement on Form S-8 (No. 33-73980)).*
10.26 Employment Agreement dated as of September 12, 1995, between the
Company and Tony L. White (incorporated by reference to Exhibit
10(21) to Annual Report on Form 10-K of the Company for the fiscal
year ended June 30, 1995 (Commission file number 1-4389)).*
10.27 Amendment dated August 17, 2001, to Employment Agreement dated as of
September 12, 1995, between the Company and Tony L. White
(incorporated by reference to Exhibit 10.l4 to Annual Report on
Form 10-K of the Company for the fiscal year ended June 30, 2001
(Commission file number 1-4389)).*
10.28 Change of Control Agreement dated as of September 12, 1995, between
the Company and Tony L. White (incorporated by reference to Exhibit
10(16) to Annual Report on Form 10-K of the Company for the fiscal
year ended June 30, 1995 (Commission file number 1-4389)).*
10.29 Employment Agreement dated as of November 16, 1995, between the
Company and Michael W. Hunkapiller (incorporated by reference to
Exhibit 10(11) to Annual Report on Form 10-K of the Company for the
fiscal year ended June 30, 1996 (Commission file number 1-4389)).*
10.30 Deferred Compensation Contract dated as of September 15, 1994,
between the Company and Michael W. Hunkapiller (incorporated by
reference to Exhibit 10(7) to Annual Report on Form 10-K of the
Company for the fiscal year ended June 30, 1995 (Commission file
number 1-4389)).*
10.31 Employment Agreement dated as of November 16, 1995, between the
Company and William B. Sawch (incorporated by reference to Exhibit
10(16) to Annual Report on Form 10-K of the Company for fiscal year
ended June 30, 1998 (Commission file number 1-4389)).*
10.32 Deferred Compensation Contract dated as of July 15, 1993, between the
Company and William B. Sawch (incorporated by reference to Exhibit
10(19) to Annual Report on Form 10-K of the Company for the fiscal
year ended June 30, 1998 (Commission file number 1-4389)).*
10.33 Letter Agreement dated June 24, 1997, between the Company and Dennis
L. Winger (incorporated by reference to Exhibit 10(18) to Annual
Report on Form 10-K of the Company for the fiscal year ended June 30,
1998 (Commission file number 1-4389)).*
10.34 Employment Agreement dated as of September 25, 1997, between the
Company and Dennis L. Winger (incorporated by reference to Exhibit
10(17) to Annual Report on Form 10-K of the Company for the fiscal
year ended June 30, 1998 (Commission file number 1-4389)).*
10.35 Employment Agreement dated as of December 1, 2000, between the
Company and Kathy P. Ordonez.*
10.36 Celera Diagnostics Joint Venture Agreement dated as of April 1, 2001,
among the Company, its Applied Biosystems Group, its Celera Genomics
Group, Foster City Holdings, LLC, and Rockville Holdings, LLC
10.37 Description of Celera Genomics/Applied Biosystems Marketing and
Distribution Agreement.
11 Computation of Net Income (Loss) per Share for the three years ended
June 30, 2002 (incorporated by reference to Note 1 to Consolidated
Financial Statements of Annual Report to Stockholders for the fiscal
year ended June 30, 2002).
13 Annual Report to Stockholders for the fiscal year ended June 30, 2002
(to the extent incorporated herein by reference).
21 List of Subsidiaries.
23 Consent of PricewaterhouseCoopers LLP.
99.1 Certification of Chief Executive Officer pursuant to Section 906
of the Sarbanes-Oxley Act of 2002.
-78-
99.2 Certification of Chief Financial Officer pursuant to Section 906
of the Sarbanes-Oxley Act of 2002.
* Management plan or compensatory plan or arrangement
(b) Reports on Form 8-K
During the quarter ended June 30, 2002, the Company did not file any
Current Reports on Form 8-K.
-79-
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.
APPLERA CORPORATION
By /s/ William B. Sawch
------------------------------------
William B. Sawch
Senior Vice President and
General Counsel
Date: September 27, 2002
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.
/s/ Tony L. White September 27, 2002
- --------------------------------------------
Tony L. White
Chairman of the Board of Directors, President
and Chief Executive Officer
(Principal Executive Officer)
/s/ Dennis L. Winger September 27, 2002
- -----------------------------------------------------
Dennis L. Winger
Senior Vice President and Chief Financial Officer
(Principal Financial Officer)
/s/ Vikram Jog September 27, 2002
- -----------------------------------------------------
Vikram Jog
Corporate Controller
(Principal Accounting Officer)
-80-
/s/ Richard H. Ayers September 27, 2002
- -----------------------------------------------------
Richard H. Ayers
Director
/s/ Jean-Luc Belingard September 27, 2002
- -----------------------------------------------------
Jean-Luc Belingard
Director
/s/ Robert H. Hayes September 27, 2002
- -----------------------------------------------------
Robert H. Hayes
Director
/s/ Arnold J. Levine September 27, 2002
- -----------------------------------------------------
Arnold J. Levine
Director
/s/ Theodore E. Martin September 27, 2002
- -----------------------------------------------------
Theodore E. Martin
Director
/s/ Georges C. St. Laurent, Jr. September 27, 2002
- -----------------------------------------------------
Georges C. St. Laurent, Jr.
Director
/s/ Carolyn W. Slayman September 27, 2002
- -----------------------------------------------------
Carolyn W. Slayman
Director
/s/ Orin R. Smith September 27, 2002
- --------------------------------------------
Orin R. Smith
Director
/s/ James R. Tobin September 27, 2002
- -----------------------------------------------------
James R. Tobin
Director
-81-
CERTIFICATIONS
Principal Executive Officer Certification
I, Tony L. White, certify that:
1. I have reviewed this annual report on form 10-K of Applera Corporation;
2. Based on my knowledge, this annual report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by
this annual report; and
3. Based on my knowledge, the financial statements, and other financial
information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of
the registrant as of, and for, the periods presented in this annual report.
Date: September 27, 2002
/s/ Tony L. White
-----------------------------------
Chief Executive Officer
Principal Financial Officer Certification
I, Dennis L. Winger, certify that:
1. I have reviewed this annual report on Form 10-K of Applera Corporation;
2. Based on my knowledge, this annual report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by
this annual report; and
3. Based on my knowledge, the financial statements, and other financial
information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of
the registrant as of, and for, the periods presented in this annual report.
Date: September 27, 2002
/s/ Dennis L. Winger
-----------------------------------
Chief Financial Officer
-82-
REPORT OF INDEPENDENT ACCOUNTANTS
ON FINANCIAL STATEMENT SCHEDULE
To the Stockholders and Board of Directors
of Applera Corporation
Our audits of the consolidated financial statements referred to in our
report dated July 25, 2002, appearing in the 2002 Annual Report to Stockholders
of Applera Corporation (which report and consolidated financial statements are
incorporated by reference in this Annual Report on Form 10-K) also included an
audit of the financial statement schedule listed in Item 14(a)(2) of this Form
10-K. In our opinion, this financial statement schedule presents fairly, in all
material respects, the information set forth therein when read in conjunction
with the related consolidated financial statements.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
Stamford, Connecticut
July 25, 2002
-83-
APPLERA CORPORATION
VALUATION AND QUALIFYING ACCOUNTS AND RESERVES
FOR THE FISCAL YEARS ENDED JUNE 30, 2000, 2001, and 2002
(Amounts in thousands)
ALLOWANCE FOR
DOUBTFUL ACCOUNTS
-----------------
Balance at June 30, 1999............................................. $ 3,834
Charged to income in fiscal year 2000................................ 3,146
Deductions from reserve in fiscal year 2000.......................... (3,015)
-------
Balance at June 30, 2000............................................. 3,965
Charged to income in fiscal year 2001................................ 3,326
Deductions from reserve in fiscal year 2001.......................... (2,221)
-------
Balance at June 30, 2001 (1)......................................... 5,070
Charged to income in fiscal year 2002................................ 8,858
Deductions from reserve in fiscal year 2002.......................... (2,978)
-------
Balance at June 30, 2002 (1)......................................... $ 10,950
========
(1) Deducted in the Consolidated Statements of Financial Position from accounts
receivable.
SCHEDULE II
-84-
EXHIBIT INDEX
Exhibit Number
4.2 Amendment to Rights Agreement dated as of April 17, 2002,
among BankBoston, N.A., EquiServe Trust Company, N.A., and the
Company
10.13 Fourth Amendment to the Excess Benefit Plan of The
Perkin-Elmer Corporation effective October 1, 2001
10.22 Paracel, Inc. Stock Option Plan
10.35 Employment Agreement dated as of December 1, 2000, between
the Company and Kathy P. Ordonez
10.36 Celera Diagnostics Joint Venture Agreement dated as of April
1, 2001, among the Company, its Applied Biosystems Group, its
Celera Genomics Group, Foster City Holdings, LLC, and
Rockville Holdings, LLC
10.37 Description of Celera Genomics/Applied Biosystems Marketing
and Distribution Agreement
13 Annual Report to Stockholders for the fiscal year ended June
30, 2002 (to the extent incorporated herein by reference)
21 List of Subsidiaries
23 Consent of PricewaterhouseCoopers LLP
99.1 Certification of Chief Executive Officer pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
99.2 Certification of Chief Financial Officer pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002