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SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES ACT OF 1934
For Fiscal Year Ended March 31, 1999
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Commission File Number 0-23252
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IGEN INTERNATIONAL, INC.
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(Exact name of registrant as specified in its charter)
DELAWARE 94-2852543
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(State or other jurisdiction of (IRS Employer Identification No.)
incorporation or organization)
16020 INDUSTRIAL DRIVE, GAITHERSBURG, MD 20877
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(Address of principal executive offices) (Zip Code)
301/984-8000
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(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act: NONE
Securities registered pursuant to Section 12(g)
of the Act: COMMON STOCK $0.001 PAR VALUE
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(Title of Class)
Indicate by check mark whether the Registrant (1) has filed all reports required
to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes X No
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Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained to the best
of Registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
form 10-K. _
The aggregate market value of the voting and non-voting equity held by
non-affiliates of the Registrant as of June 11, 1999, computed by reference to
the closing sale price of such stock quoted on the Nasdaq National Market, was
approximately $271,638,100. For the purposes of this calculation, shares owned
by officers, directors and 5% shareholders known to the Registrant have been
deemed to be owned by affiliates.
The number of shares outstanding of the Registrant's Common Stock as of June 11,
1999 was 15,372,600.
DOCUMENTS INCORPORATED BY REFERENCE
The following documents (or parts thereof) are incorporated by reference into
the following parts of this Form 10-K. Certain information required in Part III
of this Annual Report on Form 10-K is incorporated from the Company's definitive
Proxy Statement relating to its Annual Meeting of Shareholders to be held on
September 15, 1999.
PART I
IN ADDITION TO HISTORICAL INFORMATION THIS DOCUMENT CONTAINS FORWARD-LOOKING
STATEMENTS WITHIN THE MEANING OF THE "SAFE HARBOR" PROVISION OF THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995. REFERENCE IS MADE IN PARTICULAR TO
STATEMENTS REGARDING THE POTENTIAL MARKET FOR DIAGNOSTIC PRODUCTS, POTENTIAL
IMPACT OF COMPETITIVE PRODUCTS, THE COMPANY'S EXPECTATIONS REGARDING THE LEVEL
OF ANTICIPATED ROYALTY AND REVENUE GROWTH IN THE FUTURE, THE POTENTIAL MARKET
FOR PRODUCTS IN DEVELOPMENT, THE OUTCOME OF LITIGATION, THE DESCRIPTION OF THE
COMPANY'S PLANS AND OBJECTIVES FOR FUTURE OPERATIONS, ASSUMPTIONS UNDERLYING
SUCH PLANS AND OBJECTIVES AND OTHER FORWARD-LOOKING STATEMENTS INCLUDED IN ITEM
7 - "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS" ("MD&A"). SUCH STATEMENTS ARE BASED ON MANAGEMENT'S CURRENT
EXPECTATIONS AND ARE SUBJECT TO A NUMBER OF FACTORS AND UNCERTAINTIES WHICH
COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE DESCRIBED IN THE
FORWARD-LOOKING STATEMENTS. IN PARTICULAR, CAREFUL CONSIDERATION SHOULD BE GIVEN
TO CAUTIONARY STATEMENTS MADE IN ITEM 7 - "MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS" AND IN ITEM 1 - "BUSINESS"
UNDER THE HEADING "RISK FACTORS." IGEN DISCLAIMS ANY INTENT OR OBLIGATION TO
UPDATE THESE FORWARD-LOOKING STATEMENTS.
ITEM 1. BUSINESS
IGEN International, Inc. ("IGEN" or the "Company"), together with collaborators,
develops, manufactures and markets diagnostic systems utilizing IGEN's patented
ORIGEN technology, which is based on electrochemiluminescence ("ECL"), a
universal diagnostic platform which addresses many segments of the diagnostics
industry. The Company believes that ORIGEN-based diagnostic products offer
significant advantages over existing systems by providing a combination of
enhanced speed, sensitivity, flexibility, throughput and cost effectiveness. The
Company and its collaborators design ORIGEN-based diagnostic systems for
multiple segments of the $20 billion worldwide diagnostic market, from hospital
and clinical reference laboratories to patient point-of-care, life science
research, industrial and in-home testing.
The Company has commercialized certain first generation ORIGEN-based products
for large, established markets, such as clinical reference and central hospital
laboratories, in collaboration with leading healthcare companies. All of these
products feature the ORIGEN technology as the central diagnostic operating
system. There are six ORIGEN-based product lines on the market generating
revenues from equipment and recurring reagent sales which are being sold either
by IGEN or its licensees. The Company estimates that approximately 5,000 of
these systems have been sold or placed with customers, with more than 75% of
these systems having been placed or sold in the last 24 months. The Company
directly markets two product lines, the M-SERIES High Throughput Screening
system and the ORIGEN Detection System, along with related reagents and
services, for life science research applications. Leveraging on its success in
developing and commercializing the first generation of ORIGEN-based products,
the Company's strategy is to expand its role in the manufacturing and marketing
of a new generation of ORIGEN-based products to create a universal diagnostic
platform for potential high-growth market segments, including patient
point-of-care, high throughput drug screening ("HTS") (life science research),
and food, water and animal health testing (industrial). To facilitate marketing
and distribution in certain of these new market segments, the Company may enter
into corporate collaborations.
The Company has recently completed the development of a second generation of the
ORIGEN-based system, the ECL Module ("ECLM"). The Company developed the ECLM to
be a self-contained, fully-functional
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diagnostic operating system that approximates 1/20th the size of, and is fully
compatible with, the first generation ORIGEN operating system. The ECLM reduces
the time and cost required to incorporate ORIGEN technology into many diagnostic
or analytical instruments. Because the ECLM combines small size and relatively
low cost, with speed, accuracy and sensitivity equal to the first generation of
ORIGEN-based products, the Company believes that the ECLM will accelerate the
development of products for potential high-growth market segments.
In the life science research market, IGEN has developed and is marketing the
first ECLM-based product, the M-SERIES High Throughput Screening System, for use
by biopharmaceutical companies in the drug discovery process. IGEN believes that
screening specific drug targets against libraries containing hundreds of
thousands of potential drug candidates is one of the most difficult challenges
in the biopharmaceutical industry. The M-SERIES was developed to enable the
rapid development of HTS assays and should allow biopharmaceutical companies to
perform thousands of screens per day at less cost and with greater reliability.
Leveraging on IGEN's extensive pharmaceutical contacts and its reputation in the
life science research market, the Company established its first contracts with
customers in the HTS market. Commitments to acquire the M-SERIES have been made
by Pfizer, Amgen, Bristol-Myers Squibb, Schering Plough, Merck, Abbott
Laboratories, Novo Nordisk, Agouron, Peptide Therapeutics, Zymogenetics,
Battelle and the John Wayne Cancer Institute. Shipments of the first two
M-SERIES pre-production units occurred in March, 1999.
In the point-of-care market, the Company believes that ECLM-based devices should
allow for a broad diagnostic menu, faster turnaround of tests, more accurate
diagnosis and, therefore, better and more cost-effective patient care. The broad
menu of immunoassays that has been developed by IGEN and its collaborators for
the first generation of ORIGEN-based products can be performed on, and is
available for use with, ECLM-based devices for the point-of-care market. IGEN is
currently exploring collaborative business arrangements to accelerate the
commercialization of ECLM-based products for multiple point-of-care
applications.
In the industrial market, IGEN has performed field evaluations of its ORIGEN
test for E. coli bacteria in meat and other foods with the U.S. Department of
Agriculture ("USDA") and two major food producers. This test, developed in
conjunction with the USDA Agricultural Research Service, is used in testing food
and beverage products, such as meat used in hamburger, for the bacteria which
have caused numerous outbreaks of gastrointestinal and renal disease worldwide.
According to published studies by the USDA, the ORIGEN-based test, which is
automated and creates a permanent record of test results, is 1,000 times more
sensitive and significantly faster than existing E.coli tests.
The Company has entered into collaborations with established diagnostic and
pharmaceutical companies which have provided IGEN with $80 million in license
fees and product development and marketing resources, in addition to royalties
on product sales. In 1997, revenues from these collaborations substantially
shifted from up-front license fees to royalties based on sales of equipment and
reagents.
- The Company has a collaboration with Roche Diagnostics ("Roche"),
the largest worldwide manufacturer of diagnostic equipment and
supplies, to commercialize ORIGEN-based clinical immunodiagnostic
and nucleic acid probe systems that are marketed worldwide to
central hospital and clinical reference laboratories. IGEN has
received $50 million in license fees from Roche and receives
royalties on product sales. Roche presently markets two
ORIGEN-based systems under the Elecsys product line together with
a test menu of more than 35 different
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assays (including tests for infectious diseases, anemia, cancer,
heart attacks, thyroid disease and fertility/pregnancy, as well as
other tests).
IGEN has filed a lawsuit in Maryland against Roche, which claims
multiple breaches of the license agreement between the parties and
failure by Roche to perform its material obligations under the
agreement. The timing or likelihood of resolving this matter
cannot be determined at this time. See Item 3 - "Legal
Proceedings."
- The Company has an agreement with Organon Teknika B.V. ("Organon
Teknika"), a company specializing in hospital and blood bank
products, which is a business unit of Akzo Nobel N.V., a
multinational corporation with annual revenues of approximately
$12 billion, to develop and commercialize ORIGEN-based nucleic
acid probe systems that will be marketed worldwide to clinical
diagnostic and life science research markets. Organon Teknika has
combined its proprietary nucleic acid sequence based amplification
("NASBA") technology with ORIGEN technology and markets the
NucliSens line of diagnostic virology products together with test
kits for the detection of HIV-1 RNA and CMV (cytomegalo virus).
IGEN has received $20 million under its agreements with Organon
Teknika and currently receives royalties on product sales.
- IGEN has a collaboration with Eisai Co., Ltd. ("Eisai"), a leading
Japanese pharmaceutical company, to market in Japan an
ORIGEN-based diagnostic system for agreed-upon diagnostic tests
currently focused primarily in the cancer area. Eisai introduced
its first ORIGEN-based product under the trade name Picolumi
during 1997 and IGEN receives royalties on product sales.
IGEN's executive offices, laboratories and manufacturing operations are located
at 16020 Industrial Drive, Gaithersburg, Maryland 20877.
INDUSTRY BACKGROUND
IN VITRO diagnostic testing is the process of analyzing blood, urine and other
specimens to screen for, monitor and diagnose diseases and other medical
conditions or to determine the chemical and microbiological constituents of the
specimens. The major IN VITRO procedures include immunodiagnostic, nucleic acid
probe and chemistry tests. The worldwide IN VITRO diagnostic market opportunity
for IGEN is estimated to be approximately $20.0 billion and includes diagnostic
procedures performed in three primary markets: (i) the clinical diagnostic
market, including central hospital laboratories, clinical reference laboratories
and blood banks, which are collectively estimated at $14.0 billion, and patient
point-of-care testing and home testing, which are collectively estimated at $2.0
billion; (ii) the life science research market, which is estimated at $2.0
billion, including laboratories in pharmaceutical and biotechnology companies,
universities, private institutes and the government; and (iii) the industrial
market, which is estimated at $2.0 billion, including food and water quality
assurance programs, agricultural diagnostics and animal health testing.
Immunodiagnostic tests utilize antibodies to detect specific analytes such as
viruses, hormones, therapeutic drugs and other substances present in the blood
or other specimens in extremely low concentrations. To develop an
immunodiagnostic test, an antibody is created that binds specifically to
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the analyte to be detected. The antibody is then coupled to a label that signals
to an instrument the presence of the analyte in a way that can be measured.
Immunodiagnostic tests are characterized by a relatively high rate of
technological change and the frequent introduction of new clinical tests.
Currently, most immunodiagnostic tests are performed in large centralized
hospital laboratories and clinical reference laboratories by skilled technicians
who must process the specimen, measure its volume, add reagents and use
sophisticated machines to read and calculate the results.
Nucleic acid probe tests allow the detection of disease at the fundamental
genetic level. The absence or presence of certain genes or gene mutations have
been found to be reliable indicators of specific cancers, genetic disorders and
infectious diseases. Nucleic acid probes provide a direct means of detecting
nucleic acid sequences associated with either infectious agents or certain genes
in a biological sample. One difficulty in the development of nucleic acid-based
diagnostic technology is the low concentration of nucleic acid in the sample,
which generally renders direct detection impractical. Recent solutions to this
problem, including the DNA Polymerase Chain Reaction ("PCR") and NASBA, are
capable of amplifying trace amounts of target nucleic acid hundreds of millions
of times and allow for the detection of disease-causing genes before symptoms
appear.
Chemistry tests utilize established analytical methods for measuring simple
compounds such as glucose and cholesterol, elements such as sodium and
potassium, gases and enzymes. The types of samples that can be analyzed include
biological specimens such as blood and urine as well as environmental materials,
foods and beverages. The results of the analysis can be qualitative, identifying
only the presence or absence of an analyte, or quantitative, identifying also
the precise level of the analyte in the specimen.
ORIGEN TECHNOLOGY
The ORIGEN technology is a proprietary technology based on ECL, which utilizes
labels that, when attached to a biological substance and electrochemically
stimulated, emit light at a particular wavelength to signal the presence of an
analyte. The light emission can then be measured with a high degree of accuracy
to detect and quantify the analyte. The Company's ORIGEN technology thus
provides a uniform assay format to conduct a multitude of diagnostic tests
including immunoassay, nucleic acid probe and clinical chemistry tests. The
ORIGEN technology is protected by numerous patents in the United States and
internationally.
IGEN and its collaborators are using the ORIGEN technology to develop and
commercialize diagnostic systems that offer many advantages over current
technologies. The Company believes that its ORIGEN technology offers improved
speed, sensitivity, flexibility and throughput relative to existing diagnostic
technologies and lowers the cost of diagnostic procedures. The ORIGEN system
directly measures ECL, and does not involve the use of enzymes common in
competing systems, thus permitting a simplified assay format. The ORIGEN
diagnostic systems can be automated to provide in a uniform format a large
number of immunoassay, nucleic acid probe and clinical chemistry tests. The
essential component of the ORIGEN system is the measurement module, which
consists of a flow cell containing an electrode and a light detection means such
as a photodiode. The ORIGEN measurement module has been designed so that it can
be easily incorporated into a variety of instruments from large central
laboratory random-access systems to small batch systems. The major features and
benefits of proprietary ORIGEN-based diagnostic systems are:
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FEATURE BENEFIT
Simple Assay Format Reduces time and labor in performing an assay.
Flexibility Enables a single instrument to perform
immunoassays on large and small
molecules and to perform DNA and RNA
probe assays.
Cost Reduces assay cost per test.
Speed Produces quick results.
Enables high throughput (random access).
Sensitivity Allows detection of analytes at very low concentrations.
Precision Provides highly-reproducible measurements.
Label Stability Extends reagent shelf life. Improves measurement
accuracy.
The Company has recently completed the development of a new generation of ORIGEN
technology, the ECLM. The Company developed ECLM to be a self-contained,
fully-functional diagnostic operating system that is 1/20th the size of, and
fully compatible with, the first generation ORIGEN operating system. The ECLM
reduces the time and cost required to incorporate ORIGEN technology into many
diagnostic or analytical instruments. Because the ECLM combines small size and
relatively low cost, with speed, accuracy and sensitivity equal to the first
generation of ORIGEN products, the Company believes that the ECLM will
accelerate the development of products for potential high-growth market
segments.
ORIGEN-BASED PRODUCTS
The Company is designing its diagnostic systems to create a universal diagnostic
platform for all segments of the diagnostic market, from large central
laboratories to patient point-of-care and in-home testing. The Company believes
that its ORIGEN-based technology is well suited for the development of a family
of instruments to be used in all segments of the market. The technology permits
virtually all clinical chemistry, immunodiagnostic, nucleic acid tests and tests
to be performed on the same instrument using the same detection method.
5
The following table summarizes the Company's products and development
programs.
COMMERCIAL
MARKET PRODUCT APPLICATION RIGHTS STATUS
CLINICAL DIAGNOSTIC MARKET
HOSPITAL/REFERENCE LABORATORY
SYSTEMS Elecsys 2010 Immunoassays Roche Product Sales
Elecsys 1010 Immunoassays Roche Product Sales
NucliSens/NASBA QR Nucleic Acid Probe Organon Teknika Product Sales
Detection
Picolumi Immunoassays (Japan) Eisai (Japan) Product Sales
High Throughput Elecsys Immunoassays Roche Development
System (Modular)
PATIENT POINT-OF-CARE SYSTEMS Physician Office-Elecsys Immunoassays IGEN (1) Product Sales
Physician's Office/Portable Immunoassays/Clinical IGEN Development
Hospital Analyzer Chemistry
LIFE SCIENCE RESEARCH MARKET Home Self-Testing Health Screening and IGEN Research
Monitoring
M-SERIES High Throughput Immunoassay/Nucleic Acid IGEN Product Sales
System Probe
ORIGEN Detection System and Immunoassays/Nucleic Acid IGEN Product Sales
Reagents Probe
Cell Culture Reagents Research Biologicals IGEN Product Sales
NucliSens/NASBA QR Nucleic Acid Probes Organon Teknika Product Sales
INDUSTRIAL MARKETS Environmental/Water Immunoassays and Nucleic IGEN; Development/
Testing/Food Processing Acid Probe Detection Organon Teknika Field Studies
System
Animal Health Systems Immunoassays and Nucleic IGEN Development
Acid Probe Detection
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1 IGEN currently servicing customers pursuant to preliminary injunction issued
by the Court in October, 1998.
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CLINICAL DIAGNOSTIC PRODUCTS
HOSPITAL/REFERENCE LABORATORY SYSTEMS. One of the significant applications of
the Company's ORIGEN technology is in large, highly-automated clinical
immunoassay systems of the type used in central hospital laboratories, clinical
reference laboratories and blood banks. Reference laboratories constitute the
vast majority of the clinical diagnostic market today. Reference laboratory
systems must be able to perform a wide variety of immunoassay tests on a large
number of samples both reliably and cost-effectively. The Company and its
corporate collaborators believe that systems based on the ORIGEN technology are
well suited to serve this market, and may surpass those immunoassay and nucleic
acid probe systems currently available in terms of speed, cost effectiveness and
ease of use.
One of the Company's licensees, Roche, introduced its first ORIGEN-based
random-access immunoassay system, the Elecsys 2010, for the central hospital and
reference laboratory markets in 1996. The Elecsys 2010 is designed to perform
multiple assays in a random-access mode while handling STAT tests (i.e., tests
performed on clinical samples where the results are needed immediately) without
interfering with the system workflow. Roche and Hitachi have cooperated in the
development of the Elecsys 2010, building on their successful cooperation in
clinical chemistry instrumentation. The Elecsys 2010 is designed so that it can
be integrated with Roche's clinical chemistry systems. Roche also introduced the
Elecsys 1010 system, which is a system designed for central hospital and
reference lab customers who have a lower throughput requirement. Roche offers a
competitive panel of more than 35 assays with the Elecsys systems, including
tests for infectious diseases, anemia, cancer, heart attacks, thyroid disease,
fertility/pregnancy, as well as other tests, and continues to develop additional
assays for market introduction in subsequent months and years. IGEN is
collaborating with Roche to develop additional assays for which IGEN is
reimbursed by Roche for certain of its assay development costs. Roche is also
developing the Modular, a high throughput Elecsys system. See Item 3 - "Legal
Proceedings" for a description of litigation between the Company and Roche.
IGEN and its licensee, Organon Teknika, believe that the ORIGEN technology
applied to nucleic acid probe assays will offer the advantages of greater
accuracy and efficiency that the market demands. Organon Teknika is developing
nucleic acid probe diagnostic tests that are used to analyze human gene
sequences or to detect the presence of gene sequences of infectious organisms.
Organon Teknika markets the NucliSens line of diagnostic virology products,
which combines the first nucleic acid probe system based on the ORIGEN
technology with NASBA. The NucliSens has four stages: sample preparation and
nucleic acid isolation, amplification and detection. The NASBA QR System
utilizes ORIGEN technology which provides automated, rapid, specific, sensitive
and homogenous detection. Tests on the market include a product for the direct
detection of HIV-1 RNA, both quantitatively and qualitatively, and for the
detection of CMV (cytomegalo virus). Products under development by Organon
Teknika include tests for hepatitis, chlamydia and mycobacteria. In addition to
the diagnosis of infectious disease, the NucliSens has potential applications in
the fields of genetic diseases, oncologic diseases and HLA typing for organ
transplants.
The Company's licensee in Japan, Eisai, launched its ORIGEN-based product,
the Picolumi, in 1997. The Picolumi consists of an immunodiagnostic
instrument and certain assays. Currently, there are four cancer tests on the
market and additional tests are in development.
PATIENT POINT-OF-CARE SYSTEMS. IGEN is independently developing ORIGEN-based
products that can be used to perform immunoassays and clinical chemistry tests
outside of large central laboratory settings. This market includes patient
point-of-care settings such as the physician's office, ambulatory clinics,
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hospital emergency rooms, surgical and intensive care units, hospital satellite
laboratories, nurse's stations or the hospital patient's bedside. Physicians,
patients and third-party payors have created a demand for bringing laboratory
testing closer to the patient in order to provide the medical practitioner with
faster results and, therefore, prompt feed-back to the patient. Immunodiagnostic
systems for individual physicians and group practices have had limited market
penetration because of the lengthy turnaround time for test results (1-2 days),
the need for skilled labor in performing tests and high cost. The Company
believes that the emergence of simple, accurate and cost effective diagnostic
products is shifting the site of IN VITRO diagnostic testing from the central
clinical laboratory to alternate sites.
IGEN believes that significant demand exists for immunodiagnostic and clinical
diagnostic products that reduce turnaround time and cost. IGEN's point-of-care
system is being designed to conduct tests that can provide accurate results to
the physician within 15 minutes, thereby permitting the physician to make a
timely decision regarding the patient's course of treatment. The ORIGEN
technology permits development of a system that is simple to operate at a very
low cost per test. The Company is designing its point-of-care system to consist
of a simple, low cost instrument and a line of reagents packaged in a disposable
single test or panel format. As most assays can be conducted on the ORIGEN
system in a uniform format, the Company believes that a broad menu of tests
could be marketed on its point-of-care system.
Longer-term applications of the ORIGEN technology also exist in the field of
in-home testing (patient self-testing), in which IGEN's technology may enable
the creation of compact, inexpensive diagnostic products. The Company is
exploring the feasibility of using its ORIGEN technology for such products.
LIFE SCIENCE RESEARCH PRODUCTS
M-SERIES HIGH THROUGHPUT SCREENING SYSTEM. IGEN believes that the need of
biopharmaceutical companies to find new drugs and advances in drug discovery
technologies has created an opportunity for the ORIGEN technology platform in
the biopharmaceutical industry. Advances in fields of combinatorial chemistry
and biotechnology have revolutionized drug discovery. With the advent of
combinatorial chemistry, biopharmaceutical companies have dramatically expanded
their drug candidate libraries. Developments in biotechnology and research
programs such as the Human Genome Project have greatly increased the
understanding of disease mechanisms and pathogens, providing novel therapeutic
targets. In order to exploit these advances, biopharmaceutical companies are
re-engineering their drug development processes. High Throughput Screening (HTS)
uses automation and the latest advances in technology to accelerate the
screening of compound libraries against the disease targets of interest.
In HTS, researchers are challenged to develop new target assays while reducing
costs and always processing larger numbers of samples. IGEN's ORIGEN technology
is ideally suited to provide products to the biopharmaceutical HTS market.
IGEN's M-SERIES High Throughput Screening System, based on the ECLM builds on
the applications of its first generation product, the ORIGEN Detection System.
The M-SERIES is compatible with 96 and 384 multi-well plates that are commonly
used in HTS laboratories, and can be fully integrated with existing automation
and robotic systems. It should allow researchers to perform thousands of tests
per day, with less cost and with greater sensitivity and reliability.
The sensitivity and accuracy of the M-SERIES has advantages over competitive
screening technologies. It allows the user to quickly adapt the ORIGEN
technology to target assays in weeks compared to the
8
months taken today, to reduce the use of their rare reagent, and to be more
confident in their positive and negative results. IGEN's assay expertise assists
customers with assay feasibility, development and in the performance of assay
services under full GMP compliance.
During 1998, IGEN established its first contracts with customers in the HTS
market. Commitments to acquire the M-SERIES have been made by Pfizer, Amgen,
Bristol-Myers, Squibb, Schering Plough, Merck, Abbot Laboratories, Novo Nordisk,
Agouron, Peptide Therapeutics, Zymogenetics, Battelle, and the John Wayne Cancer
Institute. Shipments of the first two M-SERIES pre-production units occurred in
March 1999.
ORIGEN DETECTION SYSTEM. IGEN currently sells the ORIGEN Detection System and a
line of related reagents and services. The ORIGEN Detection System is used by
researchers who wish to perform immunoassays for life science applications. The
ORIGEN Detection System is an open architecture assay platform that quantitates
the binding affinity of any two molecules that come together with specificity.
The "open architecture" component of ORIGEN refers to the researcher's ability
to customize their assays for their particular performance parameters. The
System is optimized for immunoassays, but offers researchers the flexibility to
build other assays for direct detection of nucleic acids and receptor ligand
studies.
ORIGEN is being implemented throughout the life science market as a replacement
technology for Radioimmunoassays (RIA) and Enzyme Linked Immunosorbent Assays
(ELISA), the most commonly used systems, as well as a replacement for newer
chemiluminescent and fluorescent procedures. IGEN's market focus on
biopharmaceuticals has resulted in successful application of ORIGEN technology
by customers in drug discovery and development, compound screening, basic
research, clinical trials, quality control and manufacturing. Biopharmaceutical
researchers are benefiting from the ORIGEN Detection System's sensitivity as
well as the reduction of time and labor, and significantly, the reduction in use
of rare assay components such as proprietary compounds, antibodies, or clinical
trial samples.
While IGEN's market focus has been on immunodiagnostic applications for
biopharmaceutical customers, the Company also has customers at government and
university research centers. Certain of these customers are performing research
in strategic IGEN growth areas such as food and water quality testing. The
Company has also broadened its assay versatility by expanding into nucleic acid
probe applications. The Company believes that ORIGEN-based technology also
sensitively detects DNA without costly amplification steps.
RESEARCH BIOLOGICALS. The Company produces and sells a line of research reagents
under its ORIGEN brand name. The products are purified biological extracts that
promote the growth of certain types of cells used in laboratory investigations.
The Company markets the products directly as well as through distributors.
INDUSTRIAL PRODUCTS
The Company is seeking to develop further, either independently or with joint
venture partners, ORIGEN-based products for use in food and water quality
assurance programs and animal health testing. The emergence of simple, accurate
and cost effective products is shifting testing from traditional labor intensive
methods such as gas chromatography, to immunodiagnostics. The Company believes
that its ORIGEN Detection System and reagents together with simpler, low-cost,
ECLM-based instruments under development will be well-suited for these market
applications.
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The Company has performed field evaluations of its ORIGEN test for E.coli
bacteria in meat and other foods with the USDA and two major food producers.
This test, developed in conjunction with the USDA Agricultural Research Service,
is used in testing food and beverage products such as meat used in hamburger,
for the bacteria which have caused numerous outbreaks of gastrointestinal and
renal disease worldwide. According to published studies by the USDA, the
ORIGEN-based test, which is automated and creates a permanent record of test
results, is 1,000 times more sensitive and significantly faster than existing
E.coli tests.
Major food and beverage producers could become primary users of the E.coli test
to ensure continued safety of food and beverage products. The major advantages
of the ORIGEN test are its ability to perform in complex sample types like
hamburger meat, in less time, with a 1,000 fold increase in sensitivity over
available methods. The IGEN test will offer food producers the ability to
efficiently test many more food samples than available methods. In addition to
E.coli, IGEN will begin field evaluations soon of other ORIGEN-based food and
beverage safety tests, such as a test for cryptosporidium parasite developed in
conjunction with the Centers for Disease Control.
COLLABORATION AND LICENSE AGREEMENTS
IGEN's business strategy is to develop and market products both independently
and in collaboration with established healthcare companies. The Company's ORIGEN
technology has already provided near-term revenues, which have enabled the
Company to pursue its strategic objectives in the diagnostic business. IGEN may
seek additional corporate collaborations to accelerate commercialization of
ECLM-based products for point-of-care applications and to facilitate marketing
and distribution of its products in certain other markets.
ROCHE -- Roche Diagnostics GmbH ("Roche") is a subsidiary of F. Hoffmann
La-Roche Ltd. of Switzerland, a multinational corporation with annual revenues
exceeding $15 billion and the largest worldwide manufacturer of diagnostic
equipment and supplies. Roche's principal strength is in the areas of clinical
chemistry and nucleic acid probe systems, in which it is the market leader. The
Company entered into an agreement under which Roche was granted rights to
develop and market clinical diagnostic systems in certain markets worldwide
based on the Company's technology. Under the agreement, IGEN received $50
million in license fees over a five-year period ending in 1996. Roche pays
additional amounts for certain assay product development being performed by
IGEN, and is obligated to pay the Company a royalty on all product sales.
The ORIGEN products being marketed by Roche under the name Elecsys, are a series
of highly-automated diagnostic systems designed for central hospital
laboratories and clinical reference laboratories. IGEN believes that Elecsys
systems will enable Roche to increase its market presence in immunodiagnostics
and to market systems capable of performing both clinical chemistry and
immunodiagnostic tests. The Company estimates that Roche has placed or sold
approximately 5,000 Elecsys systems with customers since market introduction in
mid-1996. The Company has granted Roche an exclusive right to market these
products to central hospital laboratories and clinical reference laboratories
worldwide, except for rights previously licensed to Eisai to market contained
products in Japan. The Company has also granted Roche a co-exclusive license to
use the ORIGEN technology for nucleic acid probe tests for use in centralized
hospital laboratories and clinical reference laboratories. In addition, Roche
has granted to the Company a non-exclusive license to certain improvements for
products based on the ECL technology resulting from Roche's work under its
agreement with the
10
Company. This "grant back" may be used only in fields other than central
hospital and clinical reference laboratories. The Company is involved in
litigation with Roche. See Item 3 -" Legal Proceedings."
The Company recorded royalty income and license fees from the Roche agreement of
$7.1 million, $4.4 million and $8.6 million for the three fiscal years ended
March 31, 1997, 1998 and 1999.
ORGANON TEKNIKA B.V. Organon Teknika, a company specializing in hospital and
blood bank products, is a business unit of Akzo Nobel N.V., a multinational
corporation with annual revenues of approximately $12 billion. In 1993, the
Company entered into a $20 million license agreement and a stock purchase
agreement with Organon Teknika. The license agreement provides Organon Teknika
with co-exclusive rights to commercialize certain products utilizing the
Company's ORIGEN technology for detecting nucleic acids in centralized clinical
markets, research markets and for certain pathogens for food testing. Organon
Teknika has combined the Company's ORIGEN technology with NASBA, a proprietary
nucleic acid amplification technique. The agreement provides for royalty
payments to IGEN and for product supply arrangements. The Company also issued
shares of Common Stock to Organon Teknika and agreed to devote specified
resources to research and development activities in the field of clinical
diagnostics. Robert Salsmans, a director of the Company, is President and Chief
Executive Officer of the Organon Teknika group of companies.
EISAI CO., LTD. Eisai is a major Japanese pharmaceutical company. The Company
granted a license to Eisai to market in Japan a clinical diagnostic system
based on the Company's ORIGEN technology. Under this agreement, Eisai has
paid $8 million to IGEN as license fees and an additional $2.75 million as an
advance royalty payment. During 1997, Eisai launched an ORIGEN-based product
under the trade name Picolumi, which consists of an immunodiagnostic
instrument and certain assays for use in Japan in the market regulated by the
Japanese Ministry of Health and Welfare. Eisai currently markets three cancer
tests and one test for HTLV and is developing additional tests. The Company
receives royalties from Eisai's sales.
For the three fiscal years ended March 31, 1997, 1998 and 1999, revenue from
corporate collaborators, which is represented as product-based royalty income,
license fees and contract revenue, totaled $9.6 million (60%), $7.8 million
(58%), and $9.9 million (67%), respectively.
RESEARCH AGREEMENTS
In 1993, the Company established HyperGen, a joint venture partnership, with
Hyperion Catalysis International ("Hyperion") to develop and commercialize
biomedical products utilizing advanced materials such as Hyperion's proprietary
Graphite Fibrils nanotubes. Hyperion, a privately-held company based in
Cambridge, Massachusetts, is engaged in the development and manufacture of
Graphite Fibrils, an innovative carbon-based nanofiber. IGEN licensed the
exclusive right to use products developed by HyperGen for diagnostic
applications. The Company contributed cash of $3 million for its initial 50%
interest in HyperGen and made additional cumulative payments of $2 million based
on the attainment of certain research milestones. In December 1994, the Company
acquired the remaining 50% interest in HyperGen for $3 million. IGEN assumed
operating control of HyperGen and consolidated HyperGen's research and
development programs into the Company's internal programs.
Acquisition of the HyperGen rights to Graphite Fibrils enabled IGEN to commence
the development of proprietary products to complement its business in the
medical and life science marketplace. One product under investigation by IGEN is
a filter comprised of Graphite Fibrils that could be used as a disposable
11
electrode for ECL measurements for ORIGEN-based products. The Company's Chief
Executive Officer, Samuel Wohlstadter, is Chief Executive Officer and a
shareholder of Hyperion.
During November 1995, the Company formed a joint venture for the development and
commercialization of advanced diagnostics products utilizing a proprietary
combination of multi-array technology together with the Company's ORIGEN
technology. Products based on these technologies would be used for high
throughput, multiparameter analysis for DNA sequencing, clinical chemistry and
immunodiagnostics. The joint venture is named Meso Scale Diagnostics, LLC
("MSD"), and was formed together with Meso Scale Technologies, LLC ("MST"), a
company based in Maryland. MST is a technology-based company established and
operated by Jacob Wohlstadter, the son of Samuel J. Wohlstadter, the Chief
Executive Officer of the Company. Nadine Wohlstadter, a member of MST, is the
spouse of Samuel J. Wohlstadter. The Company has agreed to provide initial
capital contributions to MSD of $5 million over time in exchange for its
ownership interest and in addition, it has agreed to fund the organizational and
certain ongoing (non-research) expenses of MSD. Furthermore, at the request of
MSD, IGEN will make available to MSD such personnel as are reasonably necessary
to permit MSD to conduct its research (such time spent by IGEN personnel would
be credited to IGEN's capital contributions). The Company will also participate
in a collaborative research program under which no funds have been expended.
MSD's research programs to develop products will be based on multi-array
diagnostic techniques and the ability to control and adapt surface chemistry
reactions on a microscopic level. The process may generate thousands of
reactions on a single chip with diagnostic results presented on an array and
read using electrochemiluminescence. The multiple results would represent an
advance in diagnostic testing enabling researchers and clinicians to explore
complex information rapidly and cost-effectively.
PATENTS AND OTHER PROPRIETARY RIGHTS
IGEN pursues a policy of seeking patent protection to preserve its proprietary
technology and its right to capitalize on the results of its research and
development activities and, to the extent it may be necessary or advisable, to
exclude others from appropriating its proprietary technology. IGEN also relies
upon trade secrets, know-how, continuing technological innovations and licensing
opportunities to develop and maintain its competitive position. The Company
prosecutes and defends its intellectual property, including its patents, trade
secrets and know-how. The Company regularly searches for third-party patents in
its fields of endeavor, both to shape its own patent strategy as effectively as
possible and to identify licensing opportunities.
IGEN owns 40 issued U.S. patents and has 45 pending U.S. applications in the
diagnostics field. Worldwide, the Company owns 85 additional issued patents and
has more than 147 pending patent applications covering the same technology.
These patents and patent applications cover various aspects of IGEN's ORIGEN
technology and products, and the methods for their production and use. IGEN
patents will not begin to expire until 2005; core ORIGEN patents will extend
through 2015. The Company continues to protect its technology with new patent
filings which could further extend its patent coverage.
The patent positions of diagnostic firms, including the Company, are highly
uncertain and involve complex legal and factual questions. The Company may have
to participate in interference proceedings declared by the U.S. Patent and
Trademark Office to determine priority of invention, which could result in
substantial cost to the Company even if the eventual outcome is favorable to the
Company.
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Consequently, the Company does not know whether its applications will result in
issued patents or whether its patents will provide significant proprietary
protection or will be circumvented or invalidated.
A number of healthcare and information technology companies and research and
academic institutions have filed patent applications or received patents in the
diagnostic field. Some of these applications or patents may be competitive with
the Company's issued patents or pending patent applications or conflict in
certain respects with claims made in the Company's patents or patent
applications or the Company's ability to practice the technology covered
thereby. Such conflicts could result in a significant reduction of the Company's
ability to practice the inventions covered by its patents and pending patent
applications. In addition, if patents containing competitive or conflicting
claims are issued to others and such claims are ultimately determined to be
valid, there can be no assurance that the Company will be able to obtain
licenses to these patents at a reasonable cost or be able to develop or obtain
alternative technology.
In June 1998, a subsidiary of Ares - Serono filed a patent infringement claim
against IGEN, Roche and Organon Teknika in U.S. District Court in Delaware. This
action claims that a patent for "A Method Assay Employing a Magnetic Electrode"
is being infringed by IGEN. The Company does not believe it infringed on the
Serono patent and intends to vigorously defend against this claim.
The Company filed an opposition in the European Patent Office in 1995 to a
patent (EP 0 285 05781) owned by Enzo Biochem, Inc. This patent covers labeled
oligonucleotides useful in DNA probe assays. Separate oppositions have been
lodged by Roche and Organon Teknika. The Company is vigorously opposing this
patent. Since the opposition is still in an early stage, it is not possible to
predict the outcome or the effect, if any, on the Company's intellectual
property or products.
GOVERNMENT REGULATION
The Company's research and development activities and the future manufacturing
and marketing of products by the Company are subject to regulation by numerous
governmental authorities in the United States and other countries. In the United
States, clinical diagnostic devices are subject to rigorous U.S. Food and Drug
Administration ("FDA") regulation. The Federal Food, Drug and Cosmetic Act and
the Public Health Service Act govern the testing, manufacture, safety, efficacy,
labeling, storage, record keeping, approval, advertising and promotion of the
Company's clinical products. In addition to FDA regulations, the Company is
subject to other federal and state regulations such as the Occupational Safety
and Health Act and the Environmental Protection Act. Product development and
approval within this regulatory framework may take a number of years and
involves the expenditure of substantial resources. In addition, there can be no
assurance that this regulatory framework will not change or that additional
regulation will not arise at any stage of the Company's product development,
which may affect approval of or delay an application or require additional
expenditures by the Company.
The Company's regulatory strategy is to pursue development and marketing
approval of its products worldwide, either independently or through corporate
collaborators. The Company intends to seek input from the regulatory authorities
at each stage of the clinical process to facilitate appropriate and timely
clinical development. The clinical development of certain products may be the
responsibility of the Company's collaborators.
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CLINICAL DIAGNOSTIC SYSTEMS
The manufacture, distribution and sale in the United States of the Company's
products for clinical diagnostic purposes will require prior authorization by
the FDA. The FDA and similar agencies in foreign countries have promulgated
substantial regulations that apply to the testing, marketing, export and
manufacturing of diagnostic products. To obtain FDA approval of a new product
for diagnostic purposes, the Company or its collaborators will in most cases be
required to submit proof of the safety and efficacy of the product, or its
"substantial equivalence" to previously marketed products. Such proof typically
entails clinical and laboratory tests. The testing, preparation of necessary
applications and processing of those applications by the FDA is expensive and
time consuming. Significant difficulties or costs may be encountered by the
Company in its efforts to obtain FDA approvals that could delay or preclude the
Company from marketing its products for diagnostic purposes. Furthermore, there
can be no assurance that the FDA will not request the development of additional
data following the original submission. With respect to patented products or
technologies, delays imposed by the governmental approval process may materially
reduce the period during which the Company or its collaborators will have the
exclusive right to exploit those products or technologies.
The Company's and its collaborative partners' diagnostic products are regulated
as medical devices. The Roche Elecsys clinical diagnostic product has received
FDA approval. Prior to entering commercial distribution, all medical devices
must undergo FDA review under one of two basic review procedures depending on
the type of assay: a Section 510(k) pre-market notification ("510(k)") or a
pre-market approval application ("PMA"). 510(k) notification is generally a
relatively simple filing submitted to demonstrate that the device in question is
"substantially equivalent" to another legally marketed device and includes tests
for therapeutic drugs and hormones. Approval under this procedure may be granted
within 90 days if the product qualifies, but generally takes longer, and may
require clinical testing. When the product does not qualify for approval under
the 510(k) procedure, the manufacturer must file a PMA to show that the product
is safe and efficacious, based on extensive clinical testing among several
diverse testing sites and population groups, and shows acceptable sensitivity
and specificity. This procedure requires much more extensive pre-filing testing
than does the 510(k) procedure and involves a significantly longer FDA review
after the date of filing. In responding to a PMA, the FDA may grant marketing
approval, may request additional information, may set restrictive limits on
claims for use or may deny the application altogether.
After product approvals have been received, they may still be withdrawn if
compliance with regulatory standards is not maintained or if problems occur
after the product reaches the market. The FDA may require surveillance programs
to monitor the effect of products which have been commercialized, and has the
power to prevent or limit further marketing of the products based on the results
of these post-marketing programs. In addition to obtaining FDA approval for each
product, under the PMA guidelines, the Company must seek FDA approval of the
manufacturing facilities and procedures. The FDA will also inspect diagnostic
companies on a routine basis for regulatory compliance with its Good
Manufacturing Practices ("GMP").
The Company's products for the physician's office market will be affected by the
Clinical Laboratory Improvement Amendments of 1988 ("CLIA"), which is intended
to insure the quality and reliability of medical testing and may have the effect
of discouraging, or increasing the cost of, testing in physicians' offices. The
regulations establish requirements for laboratories in the area of
administration, participation in proficiency testing, patient test management,
quality control, personnel, quality assurance and inspection. Under these
regulations, the specific requirements that a laboratory must meet depend
14
upon the complexity of the tests performed by the laboratory. Laboratory tests
are categorized as either waived tests, tests of moderate complexity or tests of
high complexity. Laboratories that perform either moderate or high complexity
tests must meet standards in all areas, with the major difference in
requirements between moderate and high complexity testing concerning quality
control and personnel standards. Quality control standards for moderate
complexity testing are being implemented in stages. Personnel standards for high
complexity testing are more rigorous then those for moderate complexity testing.
In general, personnel conducting high complexity testing will need more
education and experience than those doing moderate complexity testing. Under the
CLIA regulations, all laboratories performing moderately complex or highly
complex tests will be required to obtain either a registration certificate or
certificate of accreditation from the Healthcare Financing Administration
("HCFA").
Because the regulations' interpretation is uncertain, it is possible that
certain of the Company's products may be categorized as tests of high
complexity, in which case the Company's penetration of the point-of-care market
would be reduced since not all laboratories would meet the standards required to
conduct such tests. The Company understands that laboratories, including
physician office laboratories, will be evaluating the requirements of CLIA in
determining whether to perform certain types of moderate and high complexity
diagnostic tests. The Company believes that the sale of its products will not be
adversely affect by CLIA. However, no assurance can be given that the statute
and its implementing regulations will not have a material adverse impact on the
Company and its ability to market and sell any products that it develops.
Although the Company believes that it will be able to comply with all applicable
regulations regarding the manufacture and sale of diagnostic devices, such
regulations are always subject to change and depend heavily on administrative
interpretations. There can be no assurance that future changes in regulations or
interpretations made by the HHS, FDA, HCFA or other regulatory bodies, with
possible retroactive effect, will not adversely affect the Company. In addition
to the foregoing, the Company is subject to numerous federal, state and local
laws and regulations relating to such matters as safe working conditions,
laboratory and manufacturing practices, environmental, fire hazard control, and
disposal of hazardous or potentially hazardous substances. To date, compliance
with these laws and regulations has not had a material effect on the Company's
financial results, capital requirements or competitive position, and the Company
has no plans for material capital expenditures relating to such matters.
However, there can be no assurance that it will not be required to incur
significant costs to comply with such laws and regulations in the future, or
that such laws or regulations will not have a material adverse effect upon the
Company's ability to do business.
Sales of the Company's products outside the United States are also subject to
extensive regulatory requirements, which vary widely from country to country.
The time required to obtain such approval may be longer or shorter than that
required for FDA approval.
RESEARCH PRODUCTS
The Company's products that are being sold for research use only, including the
M-SERIES High Throughput Screening System, must be properly labeled as such, as
required by the FDA, but do not generally require FDA approval prior to
marketing. The FDA has begun to impose new distribution requirements and
procedures on companies selling research-only products, such as the requirement
that the seller receive specified certifications from its customers as to the
customers' intended use of the product. The Company expects that the FDA will
develop additional restrictions of this nature. The
15
Company is unable at this time to predict the form these restrictions may take,
their likely magnitude or their ultimate impact on the Company or its sales.
ENVIRONMENTAL REGULATION
Due to the nature of its current and proposed research, development and
manufacturing processes, the Company is subject to stringent federal, state and
local laws, rules, regulations and policies governing the use, generation,
manufacture, storage, air emission, effluent discharge, handling and disposal of
certain materials and wastes. Although the Company believes that it has complied
with these laws and regulations in all material respects and has not been
required to take any action to correct any noncompliance, there can be no
assurance that the Company will not be required to incur significant costs to
comply with environmental and health and safety regulations as it expands its
production operations.
REIMBURSEMENT
Third party payors, such as governmental programs and private insurance plans,
can indirectly affect the pricing or the relative attractiveness of the
Company's products by regulating the maximum amount of reimbursement they will
provide for diagnostic testing services. In recent years, healthcare costs have
risen substantially, and third-party payors have come under increasing pressure
to reduce such costs. In this regard, the Federal government, in an effort to
reduce healthcare costs, may take actions which may involve reductions in
reimbursement rates. If the reimbursement amounts for diagnostic testing
services are decreased in the future, it may decrease the amount which
physicians, clinical laboratories and hospitals are able to charge patients for
such services and consequently the price the Company can charge for its
products.
COMPETITION
Competition in the diagnostic industry is intense, and a small number of large
and well established companies are major participants. In view of the nature of
the industry, the Company has elected to rely on alliances with established
companies to exploit fully the advantages of its diagnostic systems. There can
be no assurance, however, that IGEN's corporate collaborators will be successful
in commercializing the ORIGEN technology. Furthermore, academic institutions,
government agencies and other public and private organizations conducting
research may develop potentially competing products or technologies and may
establish collaborative arrangements with competitors of the Company.
The Company's competition will be determined in part by the potential
applications for which the Company's products are developed and ultimately
approved by regulatory authorities. For certain of the Company's future
products, an important factor in competition may be the timing of market
introduction of its own or competing products. Accordingly, the relative speed
with which IGEN or its corporate collaborators can develop products, complete
the clinical trials and approval processes and supply commercial quantities of
the products to the market are expected to be important competitive factors. The
Company expects that competition with products approved for sale will be based,
among other things, on product efficacy, safety, reliability, availability,
price and patent position.
Many of the Company's existing or potential competitors have substantially
greater financial, technical and human resources than the Company and may be
better equipped to develop, manufacture and market
16
products. These companies may develop and introduce products and processes
competitive with or superior to those of the Company.
The Company's competitive position also depends upon its ability to attract and
retain qualified personnel, obtain patent protection or otherwise develop
proprietary products or processes and secure sufficient capital resources for
the often substantial period between technological conception and commercial
sales.
MANUFACTURING
The Company's current commercial manufacturing operations consist of the
manufacture of the M-SERIES High Throughput Screening System and the ORIGEN
Detection System and related reagents and cell culture research biologicals as
well as quality assurance processes. IGEN operates a qualified GMP facility. The
Company uses a variety of suppliers and believes that it does not depend on any
single-source supplier that it cannot replace in the ordinary course of
business. The Company has not yet introduced clinical diagnostic products.
Initial clinical diagnostic products, based on the Company's ORIGEN technology,
are being manufactured by the Company's corporate collaborators. Although
additional future products may be manufactured by the Company, it has not yet
developed plans for establishing manufacturing operations for these products.
SALES AND MARKETING
IGEN markets the M-SERIES High Throughput Screening System and the ORIGEN
Detection System, together with related reagents and services, directly to the
life science research market. In conjunction with the U.S. and European launch
of the M-SERIES system, the Company has expanded its direct sales force,
including the addition of application specialists and in-house technical
services personnel. The Company continues to develop marketing plans for Japan.
Substantial sales and marketing of products based on the Company's ORIGEN
technology is conducted by corporate collaborators. See "-- Collaboration and
License Agreements." The ORIGEN cell culture products are sold directly and
through distributors.
HUMAN RESOURCES
As of May 31, 1999, IGEN employed 158 individuals full-time, of whom 105 were
engaged in research, product development, manufacturing and operations support,
36 in marketing, sales and applications support and 17 in general
administration. Of the Company's employees, 53 have Ph.D. degrees. A significant
number of the Company's management and professional employees have had prior
experience with pharmaceutical, biotechnology, diagnostic or medical products,
computer software or electronics companies. None of the Company's employees is
covered by collective bargaining agreements, and management considers relations
with its employees to be good.
The Company's ability to maintain its competitive position will depend, in part,
upon its continued ability to attract and retain qualified scientific and
managerial personnel. Competition for such personnel is intense.
17
RISK FACTORS
DEPENDENCE ON THE EFFORTS OF LICENSEES AND COLLABORATORS
IGEN's business depends, in part, on the efforts of companies to which it has
licensed its technology. IGEN has licensed its technology to Organon Teknika
B.V., Eisai Co., Ltd., and Roche Diagnostics for selected markets and uses. If
these companies do not effectively develop and market products based on this
technology, IGEN's business would be adversely affected.
IGEN's license agreements allow these companies to develop products using IGEN's
technology. The licenses also authorize them to manufacture and sell those
products in selected markets.
In return for the right to use IGEN's technology, each of these companies must
pay royalties to IGEN based on revenues from products using the technology. Each
company is currently selling products based on IGEN's technology and making
royalty payments. These royalties are a significant part of IGEN's overall
revenue, accounting for 63% of revenue in fiscal year 1999. IGEN believes that
licensees have economic incentives to continue marketing products using this
technology, but IGEN cannot predict future royalty income. Future royalties will
depend on a variety of factors that are outside IGEN's control. For example, the
amount of royalties IGEN receives will depend on how diligently licensees market
products incorporating the technology. IGEN has a lawsuit against Roche, in part
because it believes Roche has not calculated and paid royalties properly and has
not marketed the technology as diligently as the license agreement requires.
In the future, IGEN expects to enter into additional license agreements or other
collaborative arrangements to develop and market products using IGEN technology.
Future royalty income will depend, in part, on whether IGEN can negotiate
suitable arrangements with other companies and whether the products using IGEN's
technology succeed commercially.
LITIGATION AGAINST ROCHE AND HITACHI
IGEN is currently involved, directly and indirectly, in two separate lawsuits
with its licensee Roche. Roche is the largest licensee of IGEN's technology in
terms of royalty income. IGEN cannot predict whether it will succeed in this
litigation.
IGEN is currently suing Roche in Maryland federal court about disputes over a
license agreement between the two companies. This license agreement gives Roche
the exclusive right to manufacture, market and sell diagnostic equipment, and
related assays, using IGEN's patented ORIGEN technology, to central hospital
laboratories and clinical reference laboratories. The license restricts Roche's
rights in the Japanese clinical diagnostic market.
In the lawsuit, IGEN claims that Roche has not performed a variety of its
obligations under the license agreement. Allegations include the following:
- Roche has not developed and commercialized ORIGEN technology
according to an agreed-upon timetable.
- Roche has not diligently marketed the licensed technology.
18
- Roche continues to market products on which it does not have to
pay royalties, even though the license agreement required it to
phase out these products.
- Roche has marketed and sold products to customers that are not
permitted under the license.
- Roche has disregarded certain confidentiality obligations that
apply to the ORIGEN technology.
- Roche has not maintained its corporate records in a way that would
allow it to accurately calculate the royalties it owes to IGEN.
- Roche has not properly computed royalties and has underpaid
royalties to IGEN.
Based on the violations by Roche of the license agreement, IGEN asked the court
to do three principal things:
- Award monetary damages to compensate IGEN for Roche's failure to
perform its contractual obligations.
- Prohibit Roche from violating the license agreement in the future.
- Determine that IGEN is entitled to terminate the agreement with
Roche because of Roche's material breaches.
During 1998, IGEN asked the court to issue a preliminary injunction because it
believed Roche was selling outside of its authorized markets. IGEN asked the
court to:
- Prohibit Roche from selling products using ORIGEN technology to
physicians' offices and physicians' office laboratories which are
not within Roche's licensed field.
- Direct Roche to transfer its current unauthorized customers to
IGEN for future orders of reagents.
- Direct Roche to place all income from its unauthorized sales in
an escrow account until completion of the litigation.
The court granted IGEN's motion in July 1998 and issued a preliminary injunction
in October 1998. Roche has appealed the decision to the Fourth Circuit Court of
Appeals. This appeal is currently pending.
In December 1998, Roche filed a counterclaim with the court against IGEN. In
that counterclaim, Roche asserted complaints for fraud, breach of contract,
tortuous interference with business relations, unjust enrichment/equitable
recoupment and contract reformation. IGEN believes that Roche's claims are
unfounded. In March 1999, IGEN asked the court to dismiss Roche's claims for
fraud, tortious interference with business relations, unjust
enrichment/equitable recoupment and contract reformation. IGEN also asked the
court to dismiss a small portion of Roche's breach of contract claim and to
dismiss Roche's request for damages and injunctive relief. After receiving
IGEN's motion to dismiss, Roche dropped its complaint for contract reformation
and part of its tortious interference complaint. In June 1999, the court
dismissed Roche's claims for fraud, tortious interference, and unjust
enrichment/equitable recoupment and refused Roche's request for punitive damages
and injunctive relief. Roche's breach of contract counterclaim remains
oustanding.
19
In addition to the Maryland lawsuit, IGEN is suing Roche's Japanese
manufacturer, Hitachi Ltd. in Japan. Hitachi manufactures diagnostic equipment
based on ORIGEN technology for Roche. IGEN believes Hitachi's actions in Japan
violate certain rights IGEN originally granted to Eisai to develop, manufacture
and sell products using ORIGEN technology to the Japanese clinical diagnostic
market. IGEN asked the Japanese court for the following actions to remedy
Hitachi's violations:
- Prohibit Hitachi from manufacturing, using or selling, in Japan,
the Elecsys 2010 Instrument (Roche's immunoassay instrument that
is based on ORIGEN technology in Japan).
- Order Hitachi to destroy all of the Elecsys instruments in
Hitachi's possession.
IGEN is vigorously pursuing these lawsuits against Roche and Hitachi and it
believes that the lawsuits are well-founded. It cannot be certain, though, that
IGEN will win in either lawsuit. The lawsuits may present certain risks to
IGEN's current and future business.
With respect to IGEN's current business, IGEN does not believe that the lawsuit
against Roche is affecting Roche's sales of products incorporating ORIGEN
technology or the royalties IGEN receives as a result of those sales. IGEN has
voluntarily agreed not to terminate the license agreement with Roche until the
court determines that it has that right. Therefore, during the course of this
litigation, Roche has the right to continue selling products based on ORIGEN
technology to central hospital laboratories and to clinical reference
laboratories, and IGEN expects to continue receiving royalties, as calculated by
Roche, for those sales.
With respect to IGEN's future prospects, the lawsuit against Roche could affect
IGEN's business in a variety of ways. First, if the court determines that Roche
has not miscalculated or underpaid royalties, the future royalty revenue from
Roche's Elecsys products could be materially less than expected amounts.
Although IGEN does not believe its own product development efforts would suffer
directly, there would be less money available, all other things being equal, to
devote to product development. Second, although IGEN does not believe that
Roche's sales of licensed products, or the resulting royalty revenue, would
suffer if IGEN lost the lawsuit, this is not certain. And, finally, if the court
decides that IGEN may terminate the license agreement with Roche and IGEN
chooses to do so, there would be risks in connection with the termination. If
IGEN were to terminate the agreement, royalty revenues could suffer temporarily
until IGEN found a suitable replacement for Roche. IGEN's overall income may
significantly decrease. Furthermore, at this time, IGEN cannot be sure that it
would be able to find a suitable replacement.
Like the Roche litigation, the lawsuit against Hitachi also presents business
risks. If IGEN wins the lawsuit against Hitachi, Roche would need to find a new
manufacturer for equipment based on ORIGEN technology or make arrangements for
Hitachi to manufacture the equipment outside of Japan. As a result, IGEN royalty
income could suffer if Roche experiences supply problems. On the other hand, if
IGEN loses the lawsuit, it does not foresee any direct adverse effects. IGEN
does not believe that royalty income would suffer if it lost the Hitachi
lawsuit. Hitachi would be able to continue manufacturing equipment using IGEN
technology for Roche in Japan and IGEN would still be entitled to royalties
based on the sales of the equipment.
20
COMPETING AGAINST MORE ESTABLISHED COMPANIES AND INSTITUTIONS
IGEN is a relatively young company in a highly competitive industry. It competes
against established diagnostic companies and with research and academic
institutions, and IGEN expects this competition to intensify. Many of these
companies and institutions have one or more competitive advantages: more money
to invest; greater technical expertise in developing and marketing products; a
larger, more experienced workforce; and more experience in obtaining regulatory
approval for diagnostic products.
NEED FOR ADDITIONAL CAPITAL
IGEN may need to raise substantial amounts of money to fund a variety of future
activities, including the following:
- Development efforts: IGEN will have to spend a substantial amount
of time and effort for research and development to successfully
develop its technology.
- Regulatory approval: IGEN will need to obtain regulatory approval
for certain of its products. It plans to get approval by showing
that these products are "substantially equivalent" to products
that have already been approved. If IGEN does not succeed, it will
have to conduct extensive clinical trials at substantial expense
to gain regulatory approval. Costs for obtaining regulatory
approval will depend on the method used to gain regulatory
approval and the amount of time and effort that must be invested.
- Patent protection: IGEN needs to protect its technology by filing
and prosecuting patent applications. It will need to enforce
patent rights against infringement by competitors. IGEN's patent
related expenses will depend on how many applications IGEN files,
the amount and strength of opposition to filings, and the cost of
enforcing intellectual property rights against competitors who
infringe IGEN's patents.
- Technological innovation: IGEN will need to respond to innovations
by our competitors. For example, it may have to invest more money
in research and development to respond to improvements in
competing technologies.
- Market changes: IGEN will need to respond appropriately to changes
in the market. For example, it may have to spend more to keep
qualified employees if competition increases for scientists.
- Licensing situation: IGEN may need to make new arrangements for
marketing its technology. In particular, if IGEN succeeds in its
lawsuit against Roche, it may have to look for a company to
replace Roche in marketing products to central hospital
laboratories and to clinical research laboratories. If IGEN is not
able to find a suitable replacement, it may have to market the
products directly, which would require additional investments to
expand manufacturing and marketing capabilities.
- Manufacturing: Currently, IGEN does not have the ability to
manufacture certain products commercially. It may look for a
company to manufacture its products. If not, or if it does not
find an appropriate manufacturer, IGEN may need to invest
substantial amounts to build or buy its own facilities.
- Sales and marketing: Currently, IGEN does not have multiple sales
teams to market different products to different markets. As with
manufacturing, it
21
may look for a company to provide sales, marketing and
distribution services for certain products. Alternatively, IGEN
may need to build its own sales and distribution force.
IGEN has a variety of funding options, but it cannot be certain that it will
have access to enough funds to successfully develop the business. IGEN expects
to need additional capital in the future, which it could raise by issuing
additional debt securities or selling additional common or preferred stock,
which could dilute the holdings of existing stockholders. If IGEN is unable to
raise additional capital, it may have to scale back, or even eliminate, some
programs. Alternatively, IGEN may have to consider arrangements with other
companies, such as granting licenses or entering into joint ventures. These
arrangements could require that IGEN give up some rights to technology or
products.
NEED FOR QUALIFIED STAFF
IGEN needs to hire additional staff and retain existing staff, which is
difficult in today's competitive marketplace. Because IGEN is a technology
company, it depends heavily on scientists to develop products and to build a
successful business. Research and development efforts could suffer if IGEN were
not able to hire and retain enough qualified scientists. IGEN cannot be sure
that it will succeed in its hiring and retention efforts. There is competition
against other technology companies and research and academic institutions for
experienced scientists. Many of these companies and institutions have greater
resources than IGEN.
In addition to scientists, IGEN will also need to hire managers as the business
grows. IGEN will need managers who are able to address the need for regulatory,
manufacturing and marketing capabilities. If IGEN is not able to hire managers
with these skills, or develop expertise in these areas, its business prospects
could suffer.
IGEN also relies on outside consultants and advisors to create research and
development strategies. Most consultants and advisors work for other companies.
Their other commitments could make them unavailable to work for IGEN when needed
in the future. This could hurt IGEN's ability to formulate effective research
and development strategies.
FDA APPROVAL REQUIRED FOR CLINICAL PRODUCTS
The Company's products that are being sold for research use only, including the
M-SERIES High Throughput Screening System, must be properly labeled as such, as
required by the FDA, but do not generally require FDA approval prior to
marketing. IGEN must obtain FDA approval before it can market clinical
diagnostic products. The FDA regulates many areas in which IGEN conducts
research and in which it develops, produces and markets products. In the United
States, IGEN (or the companies with whom it works) will need to submit data from
clinical trials demonstrating that its clinical diagnostic systems are
substantially equivalent to diagnostic systems that have already been approved.
Until the FDA determines that an ORIGEN-based system is substantially
equivalent, IGEN cannot sell that system for clinical use in the United States.
Typically, the FDA review process is a 90-day process, but the FDA's review
could take longer. In addition, IGEN cannot be sure that it will be able to
demonstrate substantial equivalence for present or future diagnostic systems. If
IGEN does not successfully demonstrate substantial equivalence, it will have to
conduct extensive clinical testing of these products. Extensive testing could
involve substantial additional costs and might delay bringing clinical
diagnostic products to market.
22
REGULATION OF PRODUCTS AND MANUFACTURING
It may cost a substantial amount to comply with the regulations of the FDA and
other governmental agencies. Government agencies, such as the FDA and the EPA,
regulate manufacturers of diagnostic products and the manufacturing process. The
costs of complying with governmental regulations and with any restrictions that
might be imposed could have a significant impact on IGEN's business. Whether
IGEN manufactures products or uses another company, the FDA will continually
review and periodically inspect the manufacturing process. If the FDA discovered
a problem with IGEN's products, the manufacturing process or the manufacturing
facility, it could place restrictions on these products and on the manufacturer.
For example, the FDA could require IGEN to recall, or even to totally withdraw,
a product from the market. In addition to FDA regulations, the process of
manufacturing products will be subject to a variety of environmental and safety
laws and regulations, including laws and regulations governing the use and
disposal of hazardous materials.
LACK OF MANUFACTURING AND MARKETING EXPERIENCE
IGEN lacks experience in large-scale manufacturing of diagnostic equipment and
it is not currently equipped to manufacture all products. There are two options
to address this problem. IGEN could expand the internal ability to manufacture
products in compliance with FDA regulations or IGEN could contract with a third
party to manufacture products for it. If IGEN cannot develop its own
manufacturing capacity or find a suitable manufacturer in a timely manner, it
will be delayed in introducing products to the market. A delay could put IGEN at
a competitive disadvantage and could harm the financial condition of IGEN.
IGEN will also need to develop greater selling, marketing and distribution
capabilities. To market clinical diagnostic products directly, IGEN would need
to develop a substantial sales force with technical expertise. It would also
need to establish a distribution system to support the sales force.
Alternatively, IGEN could license or contract with another company to provide
sales and distribution services for products, in much the same way as was done
with Roche, Eisai and Organon Teknika. IGEN cannot be sure, however, that it
will be able to develop its own sales and distribution force or that it will be
able to find a suitable company to fill that role for it.
DEPENDENCE ON PATENTS
IGEN's business depends heavily on patents, which will expire in time and may be
challenged or circumvented by competitors. IGEN's strategy is to file patent
applications covering its technology and products. Patents allow IGEN to prevent
others, for a time, from using IGEN's inventions to compete against it. IGEN's
success or failure will depend, in part, on its ability to obtain and maintain
adequate patent protection for the ORIGEN technology.
IGEN has over 147 patent applications pending in the United States and abroad.
It cannot be sure, though, that any patents will actually be issued as a result
of these applications. In the United States, IGEN owns or co-owns 40 patents
providing exclusive rights in the diagnostic market; in other parts of the world
IGEN owns or co-owns 45 patents in its field. . IGEN patents will not begin to
expire until 2005; core ORIGEN patents will extend through 2015. IGEN will
continue to file new patent applications which could extend patent coverage of
ORIGEN technology beyond that time.
23
IGEN also cannot be certain that current patents or future patents will
adequately protect its technology from use by competition. The breadth of claims
in medical patents depends on complex factual issues and legal standards.
Because there is no consistent policy governing the scope of these claims,
patent protection is uncertain. Companies may, for example, challenge and
invalidate patents or circumvent valid claims in patents, all of which could
make it necessary for IGEN to defend its patents in litigation. Litigation over
patents could harm IGEN's business in at least three ways. First, litigation
costs can be high, which could drain IGEN's financial resources. Second,
litigation over IGEN's patents could discourage other companies from working
with IGEN to develop and market new products. Third, if IGEN loses some patent
protection as a result of litigation, its competitive advantage could be eroded.
IGEN's success or failure will also depend, in part, on the patent rights of
others. IGEN licenses technology from other companies and academic institutions.
Because these patents are necessary to its business, IGEN must be certain that
it complies with these license agreements. IGEN's business could be harmed if it
breached these agreements and lost the rights to use this patented technology.
IGEN must also be sure that it does not infringe the patent rights of
competitors. If IGEN did infringe, there are several possibilities--IGEN may
have to alter its products or processes; it may have to obtain a license from
the patent holder; or it may be forced to abandon development work that relates
to these products. IGEN cannot be sure that it would be able to alter products
or processes or that it could obtain a license at a reasonable cost. The
business could be damaged if IGEN is unable to make necessary alterations or
obtain a necessary license. In addition, IGEN may need to litigate the scope and
validity of patents held by others. Litigation could be a substantial cost for
IGEN.
Laboratories Serono, S.A., a subsidiary of Ares-Serono, filed a patent
infringement claim against IGEN and against the licensees, Roche and Organon
Teknika, in June 1998. It claims that IGEN is violating its patent for "A Method
Assay Employing a Magnetic Electrode." IGEN is in the early stages of responding
to this claim, but does not believe that it or its licenses have been or are now
infringing the patent. IGEN will continue to vigorously defend this claim.
In an effort to defend its technology against infringement by others, IGEN is
opposing a European patent owned by Enzo Biochem, Inc. Licensees Roche and
Organon Teknika have also filed oppositions to the Enzo Biochem patent. The
disputed patent gives Enzo Biochem exclusive rights to labeled oligonucleotides
which are useful in DNA probe assays. IGEN is vigorously opposing Enzo Biochem's
patent. Because it is at an early stage in the process, IGEN cannot determine
yet what impact, if any, the Enzo Biochem patent will have on its business.
While IGEN relies heavily on patents to protect its technology, it also enters
into confidentiality agreements with licensees, employees and consultants. These
agreements prohibit them from disclosing IGEN trade secrets and other
confidential information. Despite these agreements, IGEN cannot be sure that the
information shared with others will remain confidential. It also cannot be
certain that it would have sufficient legal remedies to correct or compensate
for unauthorized disclosures. Furthermore, IGEN's confidentiality agreements do
not protect it against the possibility that competitors may make similar,
independent discoveries.
RESTRICTIONS ON PAYMENTS FOR PRODUCTS
Third-party payors, such as governments, health maintenance organizations and
private insurers, are restricting payments for health care. These restrictions
may decrease demand for IGEN's clinical diagnostic products and the price it can
charge. In many foreign markets, the government directly sets
24
the prices that diagnostic companies may charge. In the United States, IGEN
believes that federal and state lawmakers will continue to propose similar
governmental controls. Increasingly, Medicaid and other third-party payors are
challenging the prices charged for medical services, including clinical
diagnostic tests. They are also attempting to contain costs by limiting coverage
and the reimbursement level of clinical diagnostic tests and other health care
products. IGEN cannot be certain that insurers will cover clinical diagnostic
tests in the future. Without adequate coverage and reimbursement, consumer
demand for diagnostic tests will decrease. Decreased demand would likely cause
IGEN sales of clinical diagnostic products, and sales by its licensees, to fall
because fewer tests would be done or prices would be lowered, or both. Reduced
sales by IGEN or its licensees would hurt IGEN's business and its business
prospects.
YEAR 2000 POTENTIAL ISSUES
Many of the world's computer systems currently record years in a two-digit
format. Such computer systems will be unable to interpret properly dates beyond
the year 1999 which could lead to business disruptions in the U.S. and
internationally ("Year 2000" issues).
IGEN has reviewed its business, financial and accounting systems for Year 2000
issues. IGEN believes that installation of new or upgraded software to address
any Year 2000 issues can be done on time. Upgrading software is not expected to
create disruptions, malfunctions or prevent IGEN from operating its business.
The Company is assessing whether its suppliers and collaborators with Year 2000
issues can comply on time. IGEN cannot be sure that suppliers and collaborators
with Year 2000 issues can comply on time. IGEN does not expect there to be
significant future costs. The failure of suppliers and collaborators for Year
2000 could disrupt IGEN's operations.
Year 2000 compliance has not been, and is not anticipated to be, significant
based on management's best estimates. These costs are based on management's best
estimates of future events including continued availability of resources,
suppliers and collaborators. These estimates may be impacted by future events.
POTENTIAL PRODUCT LIABILITY
IGEN may not be able to adequately insure against risk of product liability. As
IGEN begins marketing products, it may face product liability for claims and
lawsuits by customers. Damages in product liability cases can be very large.
While IGEN has product liability insurance, this coverage is limited.
SIGNIFICANT OWNERSHIP BY MANAGEMENT
IGEN management has significant control over the company through stock
ownership. IGEN's officers and directors, own (or have the right to purchase)
about 36% of IGEN's common stock. IGEN's Chief Executive Officer has ownership
of about 27%. If they act together, the officers and directors have significant
influence over the election of directors and other shareholder actions.
LIMITATION OF STOCKHOLDER RIGHTS
IGEN's governing documents have provisions designed to prevent hostile
takeovers, which may limit the ability of shareholders to approve certain
transactions. According to IGEN's governing documents, stockholders can only act
at annual meetings or at special meetings of stockholders. Stockholders are not
allowed to act by written consent. In addition, stockholders are not allowed to
call for a special meeting.
25
Only IGEN's Board of Directors, the Chairman of the Board, or the President may
convene a special meeting. These provisions may make it difficult for
shareholders to force IGEN to hold special meetings. These provisions may also
limit the ability of stockholders to consider transactions that they may want to
approve such as a hostile takeover of the company. IGEN also has other
provisions which could make it more difficult for there to be a change in
control of the company. IGEN's Board of Directors can issue preferred stock and
can determine the rights of those preferred stockholders. For example, IGEN's
Board could give preferred stockholders one or more votes on issues on which
common stockholders vote. This could have the effect of diluting the voting
rights of common stockholders.
STOCK PRICE MAY FALL
IGEN's common stock currently trades on the Nasdaq National Market. The prices
of publicly traded stock often fluctuates. The price of IGEN stock may rise or
fall dramatically, even though its business performance has not changed. In the
past, the stock price of technology companies has been especially volatile. It
is expected that this will continue to be the case. In addition to these
fluctuations, an investment in IGEN could be affected by a wide variety of
factors that relate to its business. For example, the value IGEN shares could be
affected by new inventions IGEN discovers, innovations by competitors, disputes
over patents or other proprietary rights, publicity, regulations, market
conditions, and fluctuations in performance.
NO CASH DIVIDENDS
Since IGEN was formed, it has never paid cash dividends on its common stock.
There are no plans to pay cash dividends in the foreseeable future.
DILUTION OF AN INVESTMENT
IGEN officers, directors, employees and consultants have options to purchase
common stock. If they exercise their options and purchase common stock, an
investment in the company will be diluted. IGEN currently has preferred
stockholders who have the right to convert their preferred shares to common
stock. An investment would be diluted if these preferred stockholders decide to
convert their shares. An investment could be further diluted if IGEN issues
additional common stock. IGEN may need to issue more common stock in the future
to raise funds for the business.
ITEM 2. PROPERTIES
The Company's principal administrative, marketing, manufacturing and research
and development facility consists of an 84,000 square foot building located in
Gaithersburg, Maryland. The Company took occupancy of this leased facility
during 1995. The lease expires in 2005. The Company believes that its current
facility will be adequate for anticipated expansion needs.
ITEM 3. LEGAL PROCEEDINGS
On September 15, 1997, the Company filed a lawsuit in Maryland against Roche
Diagnostics GmbH (then known as Boehringer Mannheim GmbH or BMG), a German
company, to which the Company has licensed certain rights to develop and
commercialize diagnostic products based on the Company's ORIGEN technology. BMG
was acquired by F. Hoffman LaRoche during 1998, and is referred to herein
26
as Roche. That lawsuit is pending in the Southern Division of the United States
District Court for the District of Maryland. The Company's dispute with Roche
arises out of a 1992 License and Technology Development Agreement (the
"Agreement"), pursuant to which Roche developed and launched its "Elecsys" line
of diagnostic products, which is based on ORIGEN technology. The Company alleges
that Roche has failed to perform certain material obligations under the
Agreement, including development and commercialization of ORIGEN technology
according to the contractual timetable; exploitation of the license to the
extent contemplated by the parties; phase out of certain non-royalty-bearing
product lines; exploitation of ORIGEN technology only within Roche's licensed
fields; proper treatment of intellectual property rights regarding ORIGEN
technology; maintenance of records essential to the computation of royalties;
and proper computation and payment of royalties. In its lawsuit, the Company
seeks damages as well as injunctive and declaratory relief, including a judicial
determination of its entitlement to terminate the Agreement. The Company
voluntarily has agreed not to terminate the Agreement unless and until the Court
determines its entitlement to do so.
During 1998, the Company filed a motion for preliminary injunction in its
Maryland lawsuit against Roche. In that motion, the Company requested that the
court enjoin Roche from marketing, selling, or distributing its Elecsys products
outside of Roche's licensed field of use. The 1992 Agreement granted Roche
rights to develop and commercialize diagnostic systems based on the Company's
ORIGEN technology for use in centralized hospital laboratories and clinical
reference laboratories only. The Company retains the rights to exploit its
ORIGEN technology in all other clinical diagnostic markets. The Company learned
that Roche was marketing Elecsys products outside of its licensed field of use
and therefore asked the court to enjoin Roche from selling outside of its
licensed field and, in particular, to physicians' offices and physicians' office
laboratories. The Company also sought additional relief, including an order
requiring Roche to refer all customers outside of Roche's licensed field to the
Company for future reagent supply needs and to place all revenues derived from
unauthorized sales in escrow pending the outcome of the litigation. The court
granted IGEN's motion in July 1998 and issued a preliminary injunction in
October 1998. Roche has appealed the preliminary injunction.
In December 1998, Roche filed a counterclaim against the Company asserting five
causes of action: fraud, breach of contract, tortious interference with business
relations, unjust enrichment/equitable recoupment, and reformation. The Company
believes that Roche's claims are unfounded. In March 1999, the Company moved to
dismiss Roche's claims for fraud, tortious interference with business relations,
unjust enrichment/equitable recoupment and reformation. The Company also moved
the court to dismiss a portion of Roche's breach of contract claim and to strike
Roche's request for punitive damages and injunctive relief. After being served
with the Company's motion to dismiss, Roche dropped its complaint for contract
reformation and part of its tortious interference claim. In June 1999, the court
dismissed Roche's claims for fraud, tortious interference, and unjust
enrichment/equitable recoupment and struck down Roche's request for punitive
damages and injunctive relief. Roche's breach of contract counterclaim remains
outstanding.
In December 1997, IGEN International K.K.(IGEN K.K."), a Japanese subsidiary of
the Company, filed a lawsuit in Tokyo District Court against Hitachi Ltd.
("Hitachi"). The lawsuit seeks to enjoin Hitachi from infringing IGEN K.K.'s
license registration, (known in Japan as a "senyo-jisshi-ken") to prevent
Hitachi from manufacturing, using or selling the Elecsys 2010 Instrument, which
incorporates IGEN's patented ORIGEN technology, in Japan. Hitachi is the sole
manufacturer for Roche of the Elecsys 2010 immunoassay instrument. Roche is
licensed to market the Elecsys 2010 worldwide, except for Japan, to central
hospital laboratories and clinical reference laboratories. The Company's ORIGEN
technology is
27
licensed in Japan to IGEN K.K. and to Eisai Company, Ltd. The lawsuit requests
injunctive relief against Hitachi.
In June 1998, a subsidiary of Ares - Serono filed a patent infringement claim
against IGEN, Roche and Organon Teknika in U.S. District Court in Delaware. This
action claims that a patent for "A Method Assay Employing a Magnetic Electrode"
is being infringed by IGEN. The Company does not believe it infringed on the
Serono patent and intends to vigorously defend against this claim.
The Company filed an opposition in the European Patent Office in 1995 to a
patent (EP 0 285 05781) owned by Enzo Biochem, Inc. This patent covers labeled
oligonucleotides useful in DNA probe assays. Separate oppositions have been
lodged by Roche and Organon Teknika. The Company is vigorously opposing this
patent. Since the opposition is still in an early stage, it is not possible to
predict the outcome or the effect, if any, on the Company's intellectual
property or products.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matter was submitted to a vote of security holders of the Company during the
fourth quarter of the fiscal year covered by this report.
EXECUTIVE OFFICERS OF THE COMPANY
The names and ages of all executive officers of the Company at June 11, 1999 and
their respective positions and offices with the Company are set forth below.
Each officer serves without a set term.
NAME AGE POSITION
---- --- --------
Samuel J. Wohlstadter 57 Chairman, Chief Executive Officer and Director
Richard J. Massey, Ph.D. 52 President, Chief Operating Officer and Director
Robert Connelly 39 Vice President, Marketing and Sales
George V. Migausky 44 Vice President, Chief Financial Officer and Secretary
SAMUEL J. WOHLSTADTER is a founder of the Company and has been Chairman of the
Board and Chief Executive Officer since its formation in 1982. Mr. Wohlstadter
has been a venture capitalist for more than 25 years and has experience in
founding, supporting and managing high technology companies, including Amgen
Inc., a biopharmaceutical company, and Applied Biosystems, Inc., a medical and
biological research products company. Mr. Wohlstadter is also Chief Executive
Officer of Hyperion Catalysis International, an advanced materials company,
which he founded in 1981, of Pro-Neuron, Inc., a drug discovery company, which
he founded in 1985, of Proteinix Corporation, a development stage company
organized to conduct research in intracellular metabolic processes, which he
founded in 1988 and of Pro-Virus, Inc., a drug discovery company, which
commenced operations in 1994.
RICHARD J. MASSEY, PH.D. is a founder of the Company, has been President and
Chief Operating Officer of the Company since 1992, a Director of the Company
since 1990 and served as Senior Vice President since 1985. From 1981 until he
joined IGEN in 1983, Dr. Massey was a faculty member in the Microbiology and
Immunology Department at Rush Medical Center in Chicago. Prior to that, he was
Senior Research Scientist at the National Cancer Institute, Frederick Cancer
Research Center.
ROBERT CONNELLY, has been Vice President of Marketing and Sales since 1994, when
he joined the Company. Previously, Mr. Connelly was the U.S. Marketing Manager
for the Instrument Group at Abbott Laboratories, which he joined in 1983, where
he was responsible for the marketing of chemistry and hematology systems and
point-of-care and near-patient testing instruments.
GEORGE V. MIGAUSKY has been associated with IGEN as Chief Financial Officer
since 1985, assuming that position on a full-time basis in 1992. Between 1985
and 1992, in addition to serving as Chief Financial Officer of IGEN on a
part-time basis, Mr. Migausky also served as financial advisor to several other
privately held companies. Prior to joining IGEN in 1985, he spent nine years in
financial management and public accounting positions, most recently as a Manager
with the High Technology Group of Deloitte Haskins & Sells.
28
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON STOCK AND RELATED STOCKHOLDER MATTERS.
The Company's Common Stock is quoted on the NASDAQ National Market System under
the symbol IGEN. As of June 11, 1999, there were approximately 3,500 holders of
record of the Company's Common Stock. No cash dividends have been paid on the
Common Stock to date, and the Company currently intends to retain any earnings
for development of the Company's business.
The following table sets forth, for periods indicated, the range of high and low
closing sales prices of the Common Stock as quoted on the NASDAQ National Market
System.
FISCAL 1998 HIGH LOW
----------- ---- ---
First Quarter $ 8 $ 4 3/4
Second Quarter $ 13 7/8 $ 7 1/16
Third Quarter $ 15 1/8 $ 10 5/8
Fourth Quarter $ 43 $ 12 1/4
FISCAL 1999
First Quarter $ 45 3/4 $ 30 5/8
Second Quarter $ 40 $ 20 9/16
Third Quarter $ 31 1/8 $ 21 1/2
Fourth Quarter $ 35 $ 24
29
ITEM 6. SELECTED FINANCIAL DATA.
The selected financial data set forth below with respect to the Company's
consolidated statements of operations for each of the years in the three year
period ended March 31, 1999 and with respect to the balance sheets at March 31,
1999 and 1998 are derived from, and are qualified by reference to, the
consolidated financial statements that have been audited by Deloitte & Touche
LLP, independent auditors, and are included elsewhere in this Form 10-K. The
statement of operations data for each of the years in the two-year period ended
March 31, 1996, and the balance sheet data at March 31, 1997, 1996 and 1995 are
derived from audited financial statements not included in this Form 10-K. The
following selected financial data should be read in conjunction with the
consolidated financial statements and notes thereto included elsewhere in this
Form 10-K.
FISCAL YEAR ENDED MARCH 31,
- ---------------------------------------------------------------------------------------------------------
1999 1998 1997 1996 1995
---- ---- ---- ---- ----
(IN THOUSANDS, EXCEPT PER SHARE DATA)
Statement of Operations Data:
Revenues:
Product Sales $ 4,949 $ 5,614 $ 6,360 $ 4,583 $ 2,555
Royalty income 9,439 5,024 843 75 20
License fees and contract revenue 510 2,795 8,802 11,266 12,259
-------- -------- -------- -------- --------
Total 14,898 13,433 16,005 15,924 14,834
-------- -------- -------- -------- --------
Operating Costs and Expenses:
Products Costs 1,340 1,716 2,448 1,848 1,278
Research and development 14,271 11,615 13,114 14,078 12,267
Marketing, general and
administrative 13,247 11,761 10,910 8,725 8,707
-------- -------- -------- -------- --------
Total operating expenses 28,858 25,092 26,472 24,651 22,252
-------- -------- -------- -------- --------
Loss from operations (13,960) (11,659) (10,467) (8,727) (7,418)
Interest Income - net 687 54 586 1,079 1,489
Other expense (36) (225) -- -- --
-------- -------- -------- -------- --------
Net loss $(13,309) $(11,830) $ (9,881) $ (7,648) $ (5,929)
-------- -------- -------- -------- --------
-------- -------- -------- -------- --------
Net loss per share $ (1.00) $ (.82) $ (.66) $ (.52) $ (.40)
-------- -------- -------- -------- --------
-------- -------- -------- -------- --------
Shares used in computing net loss per
share 15,318 15,116 14,959 14,779 14,769
-------- -------- -------- -------- --------
-------- -------- -------- -------- --------
MARCH 31,
- -------------------------------------------------------------------------------------------------
1999 1998 1997 1996 1995
---- ---- ---- ---- ----
(IN THOUSANDS)
Balance Sheet Data:
Cash, cash equivalents and short-term
investments $ 34,374 $ 23,122 $ 9,044 $ 20,217 $ 30,226
Working capital 32,327 17,590 4,431 13,700 21,484
Total assets 45,823 30,391 17,794 29,276 37,806
Long term obligations 32,704 146 158 329 418
Accumulated deficit (81,839) (68,530) (56,700) (46,819) (39,171)
Shareholders' equity 5,590 20,862 7,882 17,435 24,998
30
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS.
OVERVIEW
The Company has devoted substantially all of its resources to the research and
development of its proprietary technologies, primarily the ORIGEN technology for
clinical diagnostic and life science research products. Historically, the
Company's sources of revenue consisted primarily of license or research payments
pursuant to licensing or collaborative research agreements. The Company has
entered into arrangements with corporate collaborators that provide for the
development and marketing of certain ORIGEN-based systems. These agreements
provide fees and royalties payable to the Company in exchange for licenses to
produce and sell products. Beginning in the fourth quarter of fiscal 1997, the
Company's revenues from license fees and contract research were substantially
replaced by royalties based on its licensees' product sales. In the fiscal year
ended March 31, 1999, 97% of the Company's revenues resulted from product sales,
either by IGEN or its corporate licensees. Going forward, the Company expects an
increasing amount of its revenues to be derived from sales of its products and
royalties from corporate collaborations; however, the Company may selectively
pursue additional strategic alliances, which could result in additional contract
revenues.
RESULTS OF OPERATIONS
YEARS ENDED MARCH 31, 1999 AND 1998. The Company had a net loss of $13.3 million
($1.00 per share) on revenues of $14.9 million for the year ended March 31,
1999. This compares with a net loss of $11.8 million ($0.82 per share) on
revenues of $13.4 million for the corresponding prior year ended March 31, 1998.
During fiscal 1999, $14.4 million (97%) of the Company's revenue was generated
from the sale of products, either directly by IGEN or from royalties on
licensees sales. This represents a 35% increase from the $10.6 million of
revenue recorded last year from comparable sources.
Pursuant to the Company's agreement with Roche, (the "Agreement"), Roche
launched its Elecsys product line in 1996, which is based on IGEN's ORIGEN
technology. The Company is involved in litigation with Roche arising out of this
agreement. See Item 3, "Legal Proceedings". One of the disputes in the
litigation relates to the computation of royalties to which the Company is
entitled under the Agreement. The Company recorded royalty income from this
Agreement of $8.6 million and $4.4 million for the years ended March 31, 1999
and 1998, respectively.
Product costs were $1.3 million (27% of product sales) for the year ended March
31, 1999 compared to $1.7 million (31% of product sales) for the corresponding
prior year. Lower product costs and improved gross margins are attributable to a
change in product mix between instruments, services and reagents and the
elimination of sales to Organon Teknika for which the Company received no gross
margin.
Operating costs, excluding product costs, increased to $27.5 million in the
fiscal 1999 compared to $23.4 million during fiscal 1998. During fiscal 1999,
research and development costs increased $2.7 million (23%) to $14.3 million
from $11.6 million in fiscal 1998 due to higher personnel and development
expenses associated with development of the M-SERIES High Throughput Screening
System. There was an increase in marketing, general and administrative expenses
in fiscal 1999 over the prior year of $1.5 million (13%) due primarily to
professional and legal fees associated with the Company's litigation with Roche.
31
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS (CONTINUED)
Financial Accounting Standards Board ("FASB") issued SFAS No. 133, ACCOUNTING
FOR DERIVATIVE INVESTMENTS AND HEDGING ACTIVITIES. SFAS 133 is effective for
years beginning after June 15, 1999. The Company does not believe that adoption
of SFAS 133 will have a material impact on its financial position or results of
operations.
Interest income, net of other expense, increased $600,000 from higher cash
balances and the reduction of interest expense associated with the advance
royalty agreement with Roche, which was repaid during the first quarter of
fiscal 1999. As a result of the Company's issuance of $30 million of notes in
March 1999, the Company's interest expense will increase in Fiscal 2000 compared
to 1999.
Income (loss) from continuing operations over the next several years is likely
to fluctuate substantially from quarter to quarter as a result of differences in
the timing of revenues earned under license and product development agreements,
and associated product development expenses.
As of March 31, 1999, the Company had net operating loss and general business
credit tax carryforwards of approximately $70 million and $3 million,
respectively. The Company's ability to utilize its net operating loss and
general business credit tax carryforwards may be subject to an annual limitation
in future periods pursuant to the "change in ownership rules" under Section 382
of the Internal Revenue Service Code of 1986, as amended.
YEARS ENDED MARCH 31, 1998 AND 1997. The Company had a net loss of $11.8 million
($.82 per share) on revenues of $13.4 million for the year ended March 31, 1998.
This compares with a net loss of $9.9 million ($.66 per share) on revenues of
$16 million for the corresponding prior year ended March 31, 1997. During fiscal
1998, $10.6 million (79%) of the Company's revenue was generated from the sale
of products, either directly by IGEN or from royalties on licensees sales. This
represents a 47% increase from the $7.2 million of revenue recorded in fiscal
1997 from comparable sources. During the fourth quarter of fiscal 1997, the
Company's license and contract revenue converted to royalty income based on
product sales of corporate licensees. Revenue from license fees and contract
research were substantially replaced by royalties based on sales. Therefore,
while royalty revenue increased during fiscal 1998, revenue from license fees
and contract research decreased to $2.8 million from $8.8 million in fiscal
1997. The Company recorded royalty income from the Agreement of $4.4 million and
$706,000 for the years ended March 31, 1998 and 1997, respectively. These
amounts were offset by a $6 million advance, secured by future royalties,
received from Roche in January 1997.
Product costs were $1.7 million (31% of product sales) for the year ended March
31, 1998 compared to $2.4 million (38% of product sales) for the corresponding
prior year. Lower product costs and improved gross margins are attributable to a
change in product mix between instruments, services and reagents and the
reduction of sales to Organon Teknika for which the Company received no gross
margin.
Operating costs, excluding product costs, decreased to $23.4 million in the
fiscal 1998 compared to $24 million during fiscal 1997. During fiscal 1998,
research and development costs decreased $1.5 million (11%) to $11.6 million
from $13.1 million in fiscal 1997 due to expiring external collaborations.
Partially offsetting this decrease was an $851,000 (8%) increase in marketing,
general and administrative expenses in fiscal 1998 over the prior year due
primarily to professional and legal fees associated with the Company's
litigation with Roche.
32
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS (CONTINUED)
Interest income, net of other expense, decreased $532,000 because of lower cash
balances through the first nine months of fiscal 1998 coupled with accrued
interest expense associated with the advanced royalty agreement with Roche
initiated during the fourth quarter of fiscal 1997.
LIQUIDITY AND CAPITAL RESOURCES
The Company has financed its operations through the sale of Preferred and Common
Stock, aggregating approximately $85 million through March 31, 1999. Also, in
March 1999, the Company completed a $30 million debt financing with John Hancock
Life Insurance Company. The seven year, 8.5% Senior Secured Notes mature in 2006
with quarterly interest only payments of $637,5000 through September 2000. In
December 2000, principal and interest installments of $1.7 million will be due
quarterly through March 2006. Collateral for the debt is represented by royalty
payments and rights of the Company to receive monies due pursuant to the
Company's license agreement with Roche. Plans for the net proceeds from this
financing include continuing research and development, as well as working
capital needs related to general corporate expenditures, including the sales and
marketing efforts related to the launch of the M-SERIES High Throughput
Screening System. In addition, the Company has received funds from collaborative
research and licensing agreements, and sales of its ORIGEN line of products. As
of March 31, 1999, the Company had $34 million in cash, cash equivalents and
short term investments. Working capital was $32.3 million at March 31, 1999.
Net cash used for operating activities was $15.5 million, $10 million, and $10.4
million during the years ended March 31, 1999, 1998 and 1997, respectively.
License and collaboration agreements between the Company and its strategic
corporate collaborators provided cumulative payments to the Company of
approximately $80 million through March 31, 1999. Additionally, the Company
received $2.75 million in August 1997 under an advance royalty agreement with
Eisai.
The Company used approximately $1.7 million, $751,000, and $778,000 of net cash
for investing activities substantially related to the acquisition of laboratory
equipment, furniture and leasehold improvements during the years ended March 31,
1999, 1998, and 1997, respectively. Additionally, during fiscal years 1999, 1998
and 1997, the Company incurred capital lease obligations of approximately
$180,000, $80,000, and $113,000, respectively, related to acquisition of
laboratory equipment, furniture and leasehold improvements. The Company believes
material commitments for capital expenditures may be required in a variety of
areas, such as product development programs. The Company has not, at this time,
made commitments for any such capital expenditures or secured additional sources
to fund such commitments.
The Company has no reason to believe that the existence of the Roche litigation
is having a material adverse affect on Roche's sales pursuant to its agreement
with IGEN or that a negative result for the Company in the Roche litigation
would have a material adverse affect on Roche's sales, although there can be no
assurance that the litigation or its outcome would not have such an effect. As
it now stands, Roche will have the right to continue to market its Elecsys
products to central hospital laboratories and clinical reference laboratories
during the term of the agreement unless and until the Company is determined to
have the right to terminate the agreement and then determines to terminate the
agreement. If the Company elects to terminate the agreement, it would have a
material adverse effect on the
33
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS (CONTINUED)
Company's royalty revenue from license sales unless and until the Company
entered into a strategic partnership with another company that is able to
commercialize diagnostic instruments to hospitals and clinical reference
laboratories. There can be no assurance, if the Company decided to terminate the
Agreement, that the Company would be able to enter into such a strategic
partnership on terms favorable to the Company.
The Company does not expect that failure to prevail in the Hitachi litigation by
itself would have a material adverse effect on the Company's revenue or sales,
since Hitachi would continue to manufacture Roche instruments and the Company
would continue to earn royalties in connection therewith. There can be no
assurance that the Company's failure in the Hitachi litigation would not have a
material adverse effect or the success by the Company in the Hitachi litigation
could have a material adverse effect on the Company's intellectual property.
Success by the Company in the Hitachi litigation could have a material adverse
effect on the Company's royalty revenues from sales of Elecsys products to the
extent that Roche's sales of Elecsys instruments are hindered because it needs
to find a new manufacturer for its instruments or make arrangements to have
Hitachi manufacture the instruments outside of Japan.
The Company has incurred and expects to incur substantial additional research
and development expenses, manufacturing costs and marketing and distribution
expenses and costs related to the Roche litigation in the future. It is the
Company's intention to selectively seek additional collaborative or license
agreements with suitable corporate collaborators, although there can be no
assurance the Company will be able to enter into such agreements or that amounts
received under such agreements will reduce substantially the Company's funding
requirements. Additional equity or debt financing may be required, and there can
be no assurance that these funds may be available on favorable terms, if at all.
The Company's future capital requirements depend on many factors, including
continued scientific progress in its diagnostics programs, the magnitude of
these programs, the time and costs involved in obtaining regulatory approvals,
the costs involved in filing, prosecuting and enforcing patent claims, competing
technological and market developments, changes in its existing license and other
agreements, the ability of the Company to establish development arrangements,
the cost of manufacturing scale-up and effective commercialization activities
and arrangements.
YEAR 2000 ISSUE
The Year 2000 ("Y2K") issue results from computer programs and hardware that are
unable to distinguish between the Year 1900 and the Year 2000; accordingly,
computer systems that have time-sensitive calculations may not properly
recognize the Year 2000. This could result in system failures or
miscalculations, causing disruptions of the Company's operations, including,
without limitation, research, manufacturing, distribution, and other business
activities. The Y2K problem may affect the Company's computer hardware,
software, systems, devices and applications, and may also affect products
manufactured by collaborators using the Company's technology.
34
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS (CONTINUED)
The Company has conducted a review of its systems to identify those areas that
could be affected by the Y2K problem and has established a program to address
Y2K issues. The Company is installing a Y2K compliant Enterprise Resource
Planning ("ERP") computer system, which will perform substantially all of the
central data processing tasks of the Company. The Company is installing this
system in order to fully integrate its financial systems with its manufacturing
and distribution systems and provide for the growth of its business and not as a
concern about the Y2K problem. The Company has completed installation of the
financial systems. While existing manufacturing and distribution systems are Y2K
compliant, the new manufacturing and distribution installations are planned for
completion during the fourth calendar quarter of 1999.
Most of the Company's other information technology systems, including desktop
computers, server computer equipment and installed commercial application
software, are relatively new and have been designed with the Y2K issue in mind.
The Company has completed testing of these information technology systems that
are material to the Company's business. To the extent that these systems are
found not to be Y2K compliant, the Company believes that any material issues can
be resolved by installing commercially available upgrades.
In addition to reviewing its systems, the Company has also considered the impact
of the Y2K issue on products that it manufactures and on products manufactured
by collaborators using the Company's technology. In all material respects,
products manufactured by the Company are Y2K compliant. The Company is aware
that certain products manufactured by collaborators using the Company's
technology may utilize calendar dates. Where known, the Company has contacted
collaborators to ascertain their awareness of the problem and their plans to
address the Y2K issue. Roche has indicated to IGEN that its Elecsys products are
currently Y2K compliant or can be made Y2K compliant with a currently available
software upgrade.
The Company has identified critical providers of information, goods and services
("Suppliers") in order to assess their Y2K compliance and has sent
questionnaires to such critical Suppliers. Although the Company cannot control
the response time of Suppliers to its surveys, the Company has assessed survey
responses received through May 31, 1999 and confirmed year 2000 readiness of
selected Suppliers. Additional open responses continue to be monitored and the
Company anticipates to have confirmed Year 2000 readiness by September 30, 1999.
The Company does not intend to contact entities that are not critical and cannot
guarantee that such entities will be Y2K compliant. There can be no assurance
that the Company's suppliers are, or will be, Y2K compliant or that a failure of
timely Y2K compliance on the part of the Suppliers would not have a material
adverse effect on the Company.
The Company's business operations are also dependent upon the Y2K readiness of
infrastructure suppliers in areas such as utilities, communications,
transportation and other services. The Company has been unable to assess the
likelihood, length or effects of failures by any of these suppliers and there
can be no assurance that such failures will not have a material adverse effect
on the Company.
The Company has not incurred, and does not expect to incur, material costs in
conjunction with its Y2K remediation plan. The majority of the costs incurred to
date are related to the installation of the ERP system. As described above, the
Company did not undertake this project to specifically address the Y2K issue and
the installation has not been accelerated or otherwise modified as a result of
the Y2K issue.
35
At the current time, the Company anticipates that its critical information and
non-information technology systems will be Y2K compliant in all material
respects before January 1, 2000. Although the Company does not expect, in view
of its Y2K readiness efforts and diversity of its suppliers and customers, the
occurrence of Y2K failures to have a material adverse effect on the financial
position or results of operations of the Company, there can be no assurance of
complete Y2K compliance.
Contingency plans for information technology systems generally anticipate use of
standard non-customized replacement modules in the event of contingencies. Work
with major collaborators and vendors to date has indicated a high awareness of
the issues and plans to address them. Alternative vendors are available for most
major supplies and raw materials. Nonetheless, it is not possible for the
Company to fully assess the likelihood or magnitude of consequences from vendor
or collaborator Y2K compliance issues. While there are no indications of major
revenue disruptions from actions of such third parties, there can be no
assurance at this time as to the future impacts of Y2K actions or inactions by
collaborators or vendors.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Changes in interest rates do not affect interest expense incurred on the
Company's long-term borrowings because it bears interest at a fixed rate. Terms
of this debt are as follows: $30 million principal, Seven year 8.5% Senior
Secured Notes secured by future royalty revenue from Roche, maturing in 2006
with quarterly interest only payments through September 2000 and quarterly
principal and interest payments through March 2006. However, the Company runs a
risk that market rates will decline and that the interest rate will exceed those
based on the then current market rate. The Company is currently not using
interest rate derivative instruments to manage its exposure to interest rate
changes.
Interest income earned on the Company's investment portfolio is affected by
changes in the general level of interest rates. The Company has invested its
excess cash generally in securities of the U.S. Treasury, money market funds,
certificates of deposit and corporate bonds. The Company invests its excess cash
in accordance with a policy objective that seeks to ensure both liquidity and
safety of principal. The policy limits investments to certain types of
instruments issued by institutions with strong investment grade credit ratings
and places restrictions on their terms and concentrations by type and issuer.
36
ITEM 8. CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
INDEX TO FINANCIAL STATEMENTS PAGE
Independent Auditors' Report 38
Consolidated Statements of Operations for the Three Years 39
Ended March 31, 1999, 1998 and 1997
Consolidated Balance Sheets at March 31, 1999 and 1998 40
Consolidated Statements of Cash Flows for the Three Years 41
Ended March 31, 1999, 1998 and 1997
Consolidated Statements of Stockholders' Equity for the Three Years 42
Ended March 31, 1999, 1998, and 1997
Notes to Consolidated Financial Statements 43
37
INDEPENDENT AUDITORS' REPORT
TO THE STOCKHOLDERS AND BOARD OF DIRECTORS
OF IGEN INTERNATIONAL, INC.:
We have audited the accompanying consolidated balance sheets of IGEN
International, Inc. (the Company) as of March 31, 1999 and 1998, and the related
consolidated statements of operations, stockholders' equity, and cash flows for
each of the three years in the period ended March 31, 1999. These financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present
fairly, in all material respects, the financial position of the Company as of
March 31, 1999 and 1998, and the results of its operations and its cash flows
for each of the three years in the period ended March 31, 1999, in conformity
with generally accepted accounting principles.
Deloitte & Touche LLP Washington, D.C.
May 10, 1999
38
IGEN INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS EXCEPT PER SHARE AMOUNTS)
1999 1998 1997
---- ---- ----
REVENUES (Notes 1 and 2):
Product sales $ 4,949 $ 5,614 $ 6,360
Royalty income 9,439 5,024 843
License fees and contract revenue 510 2,795 8,802
-------- -------- --------
Total 14,898 13,433 16,005
-------- -------- --------
OPERATING COSTS AND EXPENSES:
Product costs 1,340 1,716 2,448
Research and development (Note 2) 14,271 11,615 13,114
Marketing, general, and administrative 13,247 11,761 10,910
-------- -------- --------
Total 28,858 25,092 26,472
-------- -------- --------
LOSS FROM OPERATIONS (13,960) (11,659) (10,467)
INTEREST INCOME - NET 687 54 586
OTHER EXPENSE (Note 5) (36) (225) --
-------- -------- --------
NET LOSS $(13,309) $(11,830) $ (9,881)
-------- -------- --------
-------- -------- --------
LOSS PER SHARE (Note 1):
Basic and Diluted loss per common share $ (1.00) $ (0.82) $ (0.66)
-------- -------- --------
-------- -------- --------
SHARES USED IN COMPUTING
NET LOSS PER SHARE (Note 1) 15,318 15,116 14,959
-------- -------- --------
-------- -------- --------
SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
39
IGEN INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS EXCEPT SHARE DATA)
March 31,
ASSETS 1999 1998
------ ---- ----
CURRENT ASSETS:
Cash and cash equivalents (Note 1) $ 720 $ 1,502
Short term investments (Note 1) 33,654 21,620
Accounts receivable, net 3,252 1,552
Inventory (Note 1) 1,455 1,435
Other current assets 775 864
-------- --------
Total current assets 39,856 26,973
-------- --------
EQUIPMENT, FURNITURE, AND IMPROVEMENTS (Note 1) 9,025 7,124
Accumulated depreciation and amortization (5,397) (4,111)
-------- --------
Equipment, furniture, and improvements, net 3,628 3,013
-------- --------
NONCURRENT ASSETS:
Deferred debt issuance costs (Note 4) 1,361 --
Restricted cash (Notes 1, 4) 600 --
Other 378 405
-------- --------
Total noncurrent assets 2,339 405
-------- --------
TOTAL $ 45,823 $ 30,391
-------- --------
-------- --------
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses $ 4,924 $ 5,152
Deferred revenue (Notes 1, 2) 2,488 4,139
Obligations under capital leases (Note 8) 117 92
-------- --------
Total current liabilities 7,529 9,383
-------- --------
NONCURRENT LIABLITIES:
Note payable (Note 4) 30,000 --
Convertible preferred stock dividend payable (Note 3)
2,521 --
Obligations under capital leases (Note 8) 183 146
-------- --------
Total noncurrent liabilities 32,704 146
-------- --------
COMMITMENTS AND CONTINGENCIES (See Note 8) -- --
-------- --------
STOCKHOLDERS' EQUITY: (Notes 1, 3)
Convertible preferred stock, $0.001 par value, 10,000,000 shares
authorized, issuable in Series: Series A, 600,000 shares designated, none
issued; Series B, 25,000 shares issued and outstanding - liquidation value
of $25,000,000 plus accrued and unpaid dividends 1 1
Common stock: $.001 par value, 50,000,000 shares authorized: 15,361,465 and
15,261,240 shares issued and outstanding 15 15
Additional paid-in capital 87,413 89,376
Accumulated deficit (81,839) (68,530)
-------- --------
Total stockholders' equity 5,590 20,862
-------- --------
TOTAL $ 45,823 $ 30,391
-------- --------
-------- --------
SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
40
IGEN INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
1999 1998 1997
---- ---- ----
CASH FLOWS FROM OPERATIONS:
Net loss $(13,309) $(11,830) $ (9,881)
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on disposal of equipment, furniture and improvements -- 53 --
Depreciation and amortization 1,313 889 1,320
Deferred revenue (1,651) (1,254) (2,140)
Add (deduct) items not affecting cash:
(Increase) decrease in accounts receivable (1,700) 648 (308)
(Increase) decrease in inventory (20) 640 (426)
Decrease in other current assets 89 2 590
(Decrease) increase accounts payable and accrued expenses (228) 886 473
-------- -------- --------
Net cash used in operating activities (15,506) (9,966) (10,372)
-------- -------- --------
CASH FLOWS FROM INVESTING ACTIVITIES:
Expenditures for equipment, furniture, and improvements (1,721) (751) (778)
Sale of short-term investments 32,706 8,781 30,726
Purchase of short-term investments (44,740) (22,147) (22,764)
-------- -------- --------
Net cash (used in) provided by investing activities (13,755) (14,117) 7,184
-------- -------- --------
CASH FLOWS FROM FINANCING ACTIVITIES:
Repayment of notes receivable from sale of subscribed stock, net -- 310 40
Proceeds from note payable 30,000 -- --
Disbursements for debt issuance costs (1,361) -- --
Restricted cash (600) -- --
Issuance of convertible preferred stock, net -- 23,428 --
Issuance of common stock - net 558 1,073 200
Payments under capital lease obligations (118) (16) (263)
-------- -------- --------
Net cash provided by (used in) financing activities 28,479 24,795 (23)
-------- -------- --------
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS (782) 712 (3,211)
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR 1,502 790 4,001
-------- -------- --------
CASH AND CASH EQUIVALENTS, END OF YEAR $ 720 $ 1,502 $ 790
-------- -------- --------
-------- -------- --------
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Interest Paid $ 61 $ 12 $ 65
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Capital Lease Obligations incurred for equipment, furniture and
improvements $ 180 $ 80 $ 113
SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
41
IGEN INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(IN THOUSANDS)
Notes
Receivable
From
Convertible Additional Sale of
Preferred Stock Common Stock Paid in Accumulated Deferred Subscribed
Shares Amount Shares Amount Capital Deficit Comp. Stock Total
------ ------ ------ ------ ------- ------- ----- ----- -----
BALANCE
APRIL 1, 1996 -- -- 14,908 $ 15 $64,676 $(46,819) $(91) $ (346) $ 17,435
Issuance of shares of
common stock -- -- 79 -- 200 -- -- -- 200
Amortization of deferred
compensation
-- -- -- -- -- -- 91 -- 91
Changes in notes
receivable -- -- -- -- -- -- -- 36 36
Net loss -- -- -- -- -- (9,881) -- -- (9,881)
----- ------ ------- ----- ------- -------- ------ ----- --------
BALANCE
MARCH 31, 1997 -- -- 14,987 15 64,876 (56,700) -- (310) 7,881
Issuance of shares of
common stock -- -- 274 -- 1,073 -- -- -- 1,073
Issuance of shares of
covertible preferred
stock, net 25 $ 1 -- -- 23,427 -- -- -- 23,428
Changes in notes
receivable -- -- -- -- -- -- -- 310 310
Net loss -- -- -- -- -- (11,830) -- -- (11,830)
----- ------ ------- ----- ------- -------- ------ ----- --------
BALANCE
MARCH 31, 1998 25 1 15,261 15 89,376 (68,530) -- -- 20,862
Issuance of shares of
common stock -- -- 100 -- 558 -- -- -- 558
Preferred stock,
dividends payable -- -- -- -- (2,521) -- -- -- (2,521)
Net loss -- -- -- -- -- (13,309) -- -- (13,309)
----- ------ ------- ----- ------- -------- ------ ----- --------
BALANCE
MARCH 31, 1999 25 $ 1 15,361 $ 15 $87,413 $(81,839) $ -- $ -- $ 5,590
----- ------ ------- ----- ------- -------- ------ ----- --------
----- ------ ------- ----- ------- -------- ------ ----- --------
SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
42
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and accompanying notes.
Actual results could differ from those estimates. Certain amounts from the prior
years have been reclassified to conform to the current year presentation.
ORGANIZATION AND BUSINESS ACTIVITY - IGEN International, Inc. (the Company)
develops, manufactures, and markets diagnostic systems utilizing its patented
ORIGEN(R) technology, which is based on electrochemiluminescence.
PRINCIPLES OF CONSOLIDATION - The consolidated financial statements include the
accounts of the Company and its wholly-owned subsidiaries, IGEN Europe, Inc. and
IGEN International, K.K. All significant intercompany transactions and balances
have been eliminated.
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS - Cash equivalents include cash in
banks, money market funds, securities of the U.S. Treasury, and certificates of
deposit with original maturities of three months or less.
The company has classified its short term investments which consist of U.S.
Government Obligations and Corporate Debt-Securities as "available for sale"
which are recorded at market value. The recorded market value approximates cost.
RESTRICTED CASH - The Company has a debt service reserve of $600,000 as of March
31, 1999 that is restricted in use (See Note 4). These funds are held in trust
as collateral with increasing increments scheduled for each of the first six
quarterly note payable due dates.
CONCENTRATION OF CREDIT RISK - The Company has invested its excess cash
generally in securities of the U.S. Treasury, money market funds, certificates
of deposit and corporate bonds. The Company invests its excess cash in
accordance with a policy objective that seeks to ensure both liquidity and
safety of principal. The policy limits investments to certain types of
instruments issued by institutions with strong investment grade credit ratings
and places restrictions on their terms and concentrations by type and issuer.
The Company has not experienced any losses on its investments, due to credit
risk.
INVENTORY is recorded at the lower of cost or market using the first-in,
first-out method and consists of the following:
(in thousands) 1999 1998
-----------------------------------
Finished Goods $ 461 $ 824
Work in process 137 117
Raw materials 857 494
------ ------
Total $1,455 $1,435
------ ------
------ ------
43
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
EQUIPMENT, FURNITURE, AND IMPROVEMENTS are carried at cost. Depreciation is
computed over the estimated useful lives of the assets, generally five years,
using accelerated methods. Such property consists of the following:
(in thousands) 1999 1998
--------------------------------------------------
Laboratory equipment $3,805 $2,967
Furniture and office equipment 3,606 2,653
Leasehold improvements 1,614 1,504
------ ------
Total $9,025 $7,124
------ ------
------ ------
OTHER ASSETS - The Company amortizes the cost of purchased patent rights on a
straight-line basis over the estimated economic lives of such assets, ranging
from five to twenty-one years. Accumulated amortization on purchased product
technology rights was $249,660, $223,400 and $187,300 at March 31, 1999, 1998
and 1997, respectively. The Company amortizes debt issuance costs using the
effective interest method over the terms of the debt agreement.
REVENUE RECOGNITION - Product sales revenue is recorded as products are shipped.
Nonrefundable license fees and milestone payments and service fees in connection
with research and development contracts or commercialization agreements with
corporate partners are recognized when they are earned in accordance with the
applicable performance requirements and contractual terms. Amounts received in
advance of performance under contracts or commercialization agreements are
recorded as deferred revenue until earned.
DEFERRED INCOME TAXES - Deferred income tax assets and liabilities are computed
annually for differences between the financial statement and tax bases of assets
and liabilities that will result in taxable or deductible amounts in the future
based on enacted tax laws and rates applicable to the periods in which the
differences are expected to affect taxable income. A valuation allowance is
established when necessary to reduce deferred tax assets to the amount expected
to be realized. Income tax expense is the tax payable or refundable for the
period plus or minus the change during the period in deferred tax assets and
liabilities.
LOSS PER SHARE - Effective December 31, 1997, the Company adopted Statement of
Financial Accounting Standard No. 128 "Earnings per Share" ("SFAS 128"). The
Company's loss has been adjusted by dividends accumulated at March 31, 1999 and
1998, on the Company's Convertible Preferred Series B Stock. There was no change
in loss per share reported in prior periods related to the adoption of SFAS 128.
See Note 3.
NEW ACCOUNTING STANDARDS
In 1997, the Financial Accounting Standards Board ("FASB") issued SFAS No. 131,
DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED INFORMATION, which was
effective for years beginning after December 15, 1997. SFAS No. 131 redefines
how operating segments are determined and requires disclosures about products,
services, major customers and geographic areas. The Company operates as one
business segment with a group of similar products. With the exception of revenue
from
44
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
Roche and Eisai, no single customer accounted for more than 10% of total
revenue. Revenue from Roche totalled 61%, 39% and 56% of total revenues for the
years ended March 31, 1999, 1998 and 1997, respectively, while revenue from
Eisai totaled 17% for the year ended March 31, 1998.
In June 1998, the FASB issued SFAS No. 133, ACCOUNTING FOR DERIVATIVE
INSTRUMENTS AND HEDGING ACTIVITIES. SFAS No. 133 is effective for years
beginning after June 15, 1999 and requires recognition of all derivatives at
fair value as either assets or liabilities in the statement of financial
position. The Company does not believe that adoption of SFAS No. 133 will have a
material impact on its financial position or results of operation.
2. LICENSE AND RESEARCH AGREEMENTS
In 1992, the Company entered into an agreement with Roche Diagnostics ("Roche"),
(formerly operating as Boehringer Mannheim GmbH), under which that company was
granted rights to develop and market certain clinical diagnostic systems
worldwide based on the Company's ORIGEN technology. Under the terms of the
agreement, the Company received five $10 million license payments annually
through January 1996 which were recognized as revenue on a ratable basis through
December 1996. This agreement also provides the Company with additional payments
for certain product development work, as well as royalties on product sales. The
Company is currently in litigation with Roche (See Note 9).
During 1993, the Company entered into a $20 million license and stock purchase
agreement with Organon Teknika, B.V. Under this agreement, the Company sold
346,135 shares of common stock, granted a license to develop and market certain
diagnostic systems worldwide utilizing the Company's ORIGEN technology and
agreed to invest $5 million in research and development under a joint
development program. Among other things, the agreement provides for royalty
payments to the Company on product sales and for product supply arrangements
between the parties. Under the product supply agreement, there were no sales to
Organon Teknika during the year ended March 31, 1999 and sales were $1.3 million
and $1.4 million, respectively, for the years ended March 31, 1998 and 1997..
During 1990, the Company granted a license to Eisai Co., Ltd., to market in
Japan a certain clinical diagnostic system based on the Company's ORIGEN
technology. The agreement provided license fees of $8 million tied to the
achievement of product development milestones. This agreement also provides for
royalty payments to the Company on product sales. In August 1997, the Company
received $2.75 million as an advance royalty payment of which $ 358,000 and
$290,000 was recognized as revenue in fiscal 1999 and 1998, respectively.
During 1995, the Company formed a joint venture for the development and
commercialization of advanced diagnostic products utilizing a proprietary
combination of multi-array technology together with the Company's ORIGEN
technology. Products based on these technologies would be used for high
throughput, multiparameter analysis for DNA sequencing, clinical chemistry
and immunodiagnostics. The joint venture is named Meso Scale Diagnostics, LLC
("MSD"), and was formed together with Meso Scale Technologies, LLC ("MST"),
which is a non-controlled non-owned affiliated company. The Company has
agreed to provide initial capital contributions to MSD of $5 million over
time, plus certain start up costs, in exchange for a 50% interest and to fund
the organizational and certain ongoing (non-research) operating expenses of
MSD. The Company will also participate in a collaborative research program.
45
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
For the year ended March 31, 1999 and 1998, the Company has made contributions
of $3.6 and $2.6 million, respectively. The Company has accounted for its
investments in MSD as research and development funding arrangements and,
accordingly, has recorded its payments as research and development expense.
3. STOCKHOLDERS' EQUITY
CONVERTIBLE PREFERRED STOCK - In December 1997, the Company received net
proceeds of $23.4 million from the issuance of 25,000 shares of Series B
Convertible Preferred Stock, stated value $1,000 per share. The Series B
Convertible Preferred Stock is convertible into 1,790,831 shares of Common Stock
of the Company at a rate of $13.96 per share in accordance with the terms of the
Certificate of Designation, Powers, Preferences and Rights. The Series B
Convertible Preferred Stock entitles its holders to a dividend payment of 7.75%
compounded annually on the stated value of the stock and the Company may elect
to make the dividends payable in common shares at a rate of $13.96 per share,
rather than making the dividend payment in cash. If the Company elects to pay
such dividends in shares of common stock, the Company may issue up to 810,174
shares to the holders of Series B Convertible Preferred Stock. Earnings per
share for the years ended March 31, 1999 and 1998, have been adjusted by
accumulated dividends on Series B Convertible Preferred Stock of approximately
$2 million ($0.13 per share) and $541,000 ($.04 per share), respectively. The
resulting calculation results in Net Loss Attributable to Common Shareholders
for the years ended March 31, 1999 and 1998 of approximately $15 million ($1.00
per share) and $12.4 million ($0.82 per share), respectively.
SHAREHOLDER RIGHTS PLAN - In 1996, the Board of Directors adopted a shareholder
rights plan and declared a dividend of one preferred share purchase right for
each outstanding share of common stock par value $.001 per share, of the
Company. The dividend is effective as of November 6, 1996 with respect to the
shareholders of record on that date.
Each Right entitles the registered holder to purchase from the Company one
one-hundredth of a share of Series A Junior Participating Preferred Stock, par
value $.001 per share, of the Company at a price of $65.00 per one one-hundredth
of a Preferred Share, subject to adjustment. The description and terms of the
Rights are set forth in a Rights Plan between the Company and The First National
Bank of Boston.
STOCK OPTION PLAN - The Company adopted the 1994 Stock Option Plan under which
1,750,000 shares of Common Stock have been reserved for issuance upon exercise
of options granted to employees or consultants and the 1994 Non-Employee
Directors Stock Option Plan under which 150,000 shares of Common Stock have been
reserved for issuance upon exercise of options granted to Non-Employee
Directors. The 1994 Stock Option Plan replaced the 1985 Stock Option Plan which
expired in February 1995 and continues to have unexercised options.
The Option Plans provide for the granting of both incentive stock options
intended to qualify as such under Section 422 of the Internal Revenue Code of
1986, as amended, and supplemental stock options that do not so qualify.
Generally, the options vest 20% after year one and ratably over the following 16
quarters, expiring ten years from date of grant.
46
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
A summary of the option activity is as follows:
(in thousands) Weighted Average Range of Exercise
Number of Shares Exercise Price Price
---------------- -------------- -----
Outstanding on April 1, 1996 1,493 $2.60 $0.29 - $9.63
Granted 310 $5.00 $5.00
Exercised (79) $2.80 $0.29 - $5.50
Forfeited (83) $3.90 $0.29 - $5.50
-----
Outstanding on March 31, 1997 1,641 $2.69 $0.29 - $9.63
Granted 601 $6.67 $6.00 -$20.625
Exercised (274) $3.91 $0.29 - $8.75
Forfeited (33) $5.29 $4.57 - $5.50
-----
Outstanding on March 31, 1998 1,935 $5.52 $0.29 - $20.00
Granted -- -- --
Exercised (100) $5.58 $0.29 - $14.00
Forfeited (30) $14.38 $4.87 - $20.625
-----
Outstanding on March 31, 1999 1,805 $7.77 $0.29 - $20.625
-----
-----
(Weighted Average Remaining Contractual
Life is 5.45 years)
At March 31, 1999, there were approximately 1.3 million stock options
exercisable, under the Plan with a Weighted Average Exercise Price of $5.86.
STOCK-BASED COMPENSATION - In 1997, the Company adopted Statement of Financial
Accounting Standard No. 123 ("SFAS 123"), ACCOUNTING FOR STOCK-BASED
COMPENSATION. Upon adoption of SFAS 123, the Company continues to measure
compensation expense for its stock-based employee compensation plans using the
intrinsic value method prescribed by APB No. 25, ACCOUNTING FOR STOCK ISSUED TO
EMPLOYEES, and has provided below pro forma disclosures of the effect on net
loss and loss per share as if the fair value-based method using the
Black-Scholes model prescribed by SFAS 123 had been applied in measuring
compensation expense.
If compensation cost for the Company's fiscal 1999, 1998 and 1997 grants for
stock-based compensation had been determined consistent with the fair
value-based method of accounting per SFAS 123, the Company's pro forma net loss
and pro forma loss per share for the years ended March 31, 1999, 1998 and 1997
would be as follows:
1999 1998 1997
---- ---- ----
Net loss (in thousands)
As reported $(13,309) $(11,830) $(9,881)
Pro forma $(15,359) $(12,130) $(9,996)
Basic loss per share
As reported $ (1.00) $ (0.82) $ (0.66)
Pro forma $ (1.13) $ (0.84) $ (0.67)
47
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
The fair value of the option grant is estimated on the date of grant using the
Black-Scholes option pricing models with the following assumptions:
1999 1998 1997
---- ---- ----
Expected dividend yield 0% 0% 0%
Expected stock price volatility 82.51% 53.24% 3.5%
Risk-free interest rate 5.58% 6.74% 6%
Expected option term 5 years 5 years 5 years
4. NOTE PAYABLE
In March 1999, the Company entered into a debt financing with John Hancock
Mutual Life Insurance Company under a Note Purchase Agreement from which the
Company received $30 million. The seven year, 8.5% Senior Secured Notes mature
in 2006 with quarterly interest only payments of $637,500 through September
2000. Beginning December 2000, principal and interest installments of $1.7
million will be due quarterly through March 2006.
Collateral for the debt is represented by royalty payments and rights of the
Company to receive monies due pursuant to the Company's license agreement with
Roche. Additional collateral is represented by a Restricted Cash balance of
$600,000 initiated at closing. The Restricted Cash will have increasing
increments for each of the first six quarterly periods to a maximum of $1.7
million. Covenants within the Note Purchase Agreement include compliance with
annual and quarterly Royalty Payment Coverage Ratios which are tied to royalty
payments and debt service.
Costs associated with obtaining the debt financing totaling $1.4 million were
deferred and are represented as a noncurrent asset on the balance sheet. These
costs will be amortized over the seven year life of the Note.
The Company has committed to note principal and interest payments of $2.6
million and $4.7 million for the years ending March 31, 2000 and 2001,
respectively, and $6.9 million in each of the years ending March 31, 2002, 2003
and 2004, with payments totaling $13.8 million thereafter.
5. INCOME TAXES
For the years ended March 31, 1999, 1998 and 1997, the Company recorded no
federal or state income tax expense and did not pay federal or state tax, as
calculated by applying statutory rates to pretax income. During fiscal 1998, the
Company received a $4.75 million payment from its Japanese corporate partner,
Eisai, Ltd net of the Japanese tax withholding of $475,000. The Company
recognized revenues of $358,400 and $2.3 million under this arrangement in
fiscal 1999 and 1998, and recorded the associated foreign tax of $35,800 and
$225,000 which is reflected in Other Expense in the financial statements.
48
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
As of March 31, 1999, the Company has available for income tax reporting
purposes net operating loss and general business credit carryforwards
approximating $70 million and $3 million, respectively. These carryforwards
expire in varying amounts through March 31, 2014. The use of the Company's net
operating loss carryforward may be significantly reduced, if substantial changes
in stock ownership take place. The potential tax benefits of the unused
carryforwards have not been recorded for financial statement purposes because of
the uncertainty of realizing those benefits in the future.
The approximate tax effects of temporary differences that gave rise to the
Company's deferred tax assets and liabilities are as follows:
Year Ended March 31,
(in thousands) 1999 1998
-------------- ---- ----
Deferred tax assets:
Deferred revenue $ 945 $ 1,571
Net operating loss and tax credit carryforwards 29,603 23,727
Other 94 61
Less valuation allowance (30,642) (25,359)
-------- --------
Net deferred tax assets $ -- $ --
-------- --------
-------- --------
6. EMPLOYEE SAVINGS PLAN
The Company has an Employee Savings Plan (the Plan) qualifying under Section
401(k) of the Internal Revenue Code and subject to the Employee Retirement
Income Security Act of 1974, as amended. Effective April 1, 1997, the Company
began contributing a 25% match on the first 6% of contributions from qualified
individuals participating in the Plan. This Company contribution totaled
$180,600 and $129,000 for the years ended March 31, 1999 and 1998, respectively.
The Company is not obligated under any other postretirement benefit plan.
7. RELATED PARTIES
Certain shareholders of the Company are also shareholders of several other
companies which are considered affiliates of IGEN for the purpose of this
disclosure. As discussed in Note 2, the Company has entered into transactions
with companies that were affiliated through common shareholders. Amounts due
from affiliated companies for services rendered and certain shared costs were
approximately $44,500, and $43,500 at March 31, 1999 and 1998, respectively.
During 1997, the Company incurred approximately $212,500 in expenses under a
research contract with an affiliate. There were no such expenditures made in
fiscal years 1999 or 1998.
The Company has licensed certain diagnostic technologies from affiliated
companies and has licensed certain pharmaceutical technologies to affiliated
companies. No royalties have ever been earned or accrued under these license
agreements.
49
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
8. COMMITMENTS AND CONTINGENCIES
CAPITAL LEASES - The Company is obligated under capital lease agreements, for
certain equipment, furniture and building improvements. The aggregate discounted
lease payments are recorded as a liability, and the fair market value of the
related leased assets are capitalized and amortized over the assets estimated
useful lives. Total assets capitalized pursuant to such agreements were
approximately $500,000 at March 31, 1999 with accumulated depreciation totaling
approximately $200,000.
The future minimum payments (in thousands) under these lease agreements at March
31, 1999 are as follows:
2000 $ 156
2001 99
2002 66
2003 60
-----
Total minimum payments 381
Amount representing interest (81)
-----
Obligations under capital leases 300
Current portion (117)
-----
Obligations under capital leases - noncurrent $ 183
-----
-----
OPERATING LEASES - During 1995, the Company entered into a lease for an office,
laboratory and manufacturing facility with a term of ten years, and an option to
terminate the lease after five years. Rent expense for facility and equipment
operating leases totaled approximately $1.5 million for the years ended March
31, 1999, 1998, and 1997, respectively.
RESEARCH AGREEMENTS - The Company has entered into agreements with entities to
fund research and development programs.
At March 31, 1999, the future minimum lease and research payments under these
agreements are as follows:
Research
(in thousands) Operating Leases Agreements
---------------- ----------
2000 $1,479 $1,000
2001 1,523 200
2002 1,569 --
2003 1,615 --
2004 1,664 --
Thereafter 1,424 --
------ ------
Total $9,274 $1,200
------ ------
------ ------
50
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
9. LITIGATION
ROCHE
On September 15, 1997, the Company filed a lawsuit in Maryland against Roche
Diagnostics GmbH (then known as Boehringer Mannheim GmbH or BMG), a German
company, to which the Company has licensed certain rights to develop and
commercialize diagnostic products based on the Company's ORIGEN technology. BMG
was acquired by F. Hoffman LaRoche during 1998, and is referred to herein as
Roche. That lawsuit is pending in the Southern Division of the United States
District Court for the District of Maryland. The Company's dispute with Roche
arises out of a 1992 License and Technology Development Agreement (the
"Agreement"), pursuant to which Roche developed and launched its "Elecsys" line
of diagnostic products, which is based on ORIGEN technology. The Company alleges
that Roche has failed to perform certain material obligations under the
Agreement, including development and commercialization of ORIGEN technology
according to the contractual timetable; exploitation of the license to the
extent contemplated by the parties; phase out of certain non-royalty-bearing
product lines; exploitation of ORIGEN technology only within Roche's licensed
fields; proper treatment of intellectual property rights regarding ORIGEN
technology; maintenance of records essential to the computation of royalties;
and proper computation and payment of royalties. In its lawsuit, the Company
seeks damages as well as injunctive and declaratory relief, including a judicial
determination of its entitlement to terminate the Agreement. The Company
voluntarily has agreed not to terminate the Agreement unless and until the Court
determines its entitlement to do so.
During 1998, the Company filed a motion for preliminary injunction in its
Maryland lawsuit against Roche. In that motion, the Company requested that the
court enjoin Roche from marketing, selling, or distributing its Elecsys products
outside of Roche's licensed field of use. The 1992 Agreement granted Roche
rights to develop and commercialize diagnostic systems based on the Company's
ORIGEN technology for use in centralized hospital laboratories and clinical
reference laboratories only. The Company retains the rights to exploit its
ORIGEN technology in all other clinical diagnostic markets. The Company learned
that Roche was marketing Elecsys products outside of its licensed field of use
and therefore asked the court to enjoin Roche from selling outside of its
licensed field and, in particular, to physicians' offices and physicians' office
laboratories. The Company also sought additional relief, including an order
requiring Roche to refer all customers outside of Roche's licensed field to the
Company for future reagent supply needs and to place all revenues derived from
unauthorized sales in escrow pending the outcome of the litigation. The court
granted IGEN's motion in July 1998 and issued a preliminary injunction in
October 1998. Roche has appealed the preliminary injunction.
In December 1998, Roche filed a counterclaim against the Company asserting five
causes of action: fraud, breach of contract, tortious interference with business
relations, unjust enrichment/equitable recoupment, and reformation. The Company
believes that Roche's claims are unfounded. In March 1999, the Company moved to
dismiss Roche's claims for fraud, tortious interference with business relations,
unjust enrichment/equitable recoupment and reformation. The Company also moved
the court to dismiss a portion of Roche's breach of contract claim and to strike
Roche's request for punitive damages and injunctive relief. After being served
with the Company's motion to dismiss, Roche dropped its complaint for contract
reformation and part of its tortious interference claim. In June 1999, the court
dismissed Roche's claims for fraud, tortious interference, and unjust
enrichment/equitable
51
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
recoupment and struck down Roche's request for punitive damages and injunctive
relief. Roche's breach of contract counterclaim remains outstanding.
This litigation against Roche may have a material adverse effect upon the
Company regardless of whether the outcome is favorable or not.
The Company recorded royalty income from this Agreement of $8.6 million, $4.4
million and $706,000 for the years ended March 31, 1999, 1998 and 1997,
respectively.
HITACHI
In December 1997, IGEN International K.K.(IGEN K.K."), a Japanese subsidiary of
the Company, filed a lawsuit in Tokyo District Court against Hitachi Ltd.
("Hitachi"). The lawsuit seeks to enjoin Hitachi from infringing IGEN K.K.'s
license registration, (known in Japan as a "senyo-jisshi-ken") to prevent
Hitachi from manufacturing, using or selling the Elecsys 2010 Instrument, which
incorporates IGEN's patented ORIGEN technology, in Japan. Hitachi is the sole
manufacturer for Roche of the Elecsys 2010 immunoassay instrument. Roche is
licensed to market the Elecsys 2010 worldwide, except for Japan, to central
hospital laboratories and clinical reference laboratories. The Company's ORIGEN
technology is licensed in Japan to IGEN K.K. and to Eisai Company, Ltd. The
lawsuit requests injunctive relief against Hitachi.
OTHER MATTERS
From time to time, claims and pending legal proceedings arise that generally
involve the Company's technology and possible patent infringement. These cases
are routine matters in which disposition of such proceedings are not expected to
have a material adverse effect on the Company's financial position, results of
operations or cash flows.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE.
Not Applicable.
PART III
Certain information required by Part III is omitted from this Report in that the
Registrant will file a definitive proxy statement pursuant to Regulation 14A
(the "Proxy Statement") not later than 120 days after the end of the fiscal year
covered by this Report, and certain information included therein is incorporated
herein by reference. Only those sections of the Proxy Statement which
specifically address the items set forth herein are incorporated by reference.
52
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT.
(a) DIRECTORS. The information with respect to directors required
under this item is incorporated herein by reference to the section
captioned "Election of Directors" in the Company's Proxy Statement
with respect to the Annual Meeting of Shareholders to be held on
September 15, 1999.
(b) EXECUTIVE OFFICERS. The information with respect to executive
officers required under this item is incorporated herein by
reference to Part I of this Report.
ITEM 11. EXECUTIVE COMPENSATION.
The information required under this item is incorporated herein by reference to
the sections entitled "Election of Directors -- Compensation for Directors",
"--Compensation of Executive Officers", "--Compensation Arrangements and
Employment Agreements", "-- Report of the Compensation Committee", in the
Company's Proxy Statement with respect to the Annual Meeting of Shareholders to
be held on September 15, 1999.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT.
The information required under this item is incorporated herein by reference to
the section entitled "Principal Shareholders" in the Company's Proxy Statement
with respect to the Annual Meeting of Shareholders to be held on September 15,
1999.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS.
The information required under this item is incorporated herein by reference to
the sections entitled "Election of Directors -- Compensation Arrangements and
Employment Agreements" and "-- Certain Transactions" in the Company's Proxy
Statement with respect to the Annual Meeting of Shareholders to be held on
September 15, 1999.
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K.
(a) (1) INDEX TO FINANCIAL STATEMENTS.
The financial statements listed in the Index to Financial Statements are filed
as part of this Annual Report on Form 10-K.
(a) (2) INDEX TO FINANCIAL STATEMENT SCHEDULES.
All schedules are omitted because they are not applicable, or not required, or
because the required information is included in the financial statements or
notes thereto.
(a) (3) INDEX TO EXHIBITS.
53
The Exhibits filed as part of this Form 10-K are listed on the Exhibit Index
immediately preceding such Exhibits.
(b) REPORTS ON FORM 8-K: On March 29, 1999, the Company filed a Form
8-K announcing the Company's completion of a $30 million debt
financing with John Hancock Mutual Life Insurance Company.
(c) EXHIBITS The response to this portion of Item 14 is submitted as a
separate section of this Form 10-K.
MANAGEMENT CONTRACTS AND OTHER COMPENSATORY ARRANGEMENTS. None
(d) FINANCIAL STATEMENT SCHEDULES. All schedules are omitted because
they are not applicable, or not required, or because the required
information is included in the financial statements or notes
thereto.
54
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.
IGEN International, Inc.
June 25, 1999 By: /s/ Samuel J. Wohlstadter
--------------------------
Chief Executive Officer
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints Samuel J. Wohlstadter, Richard J. Massey and George V.
Migausky as his attorney-in-fact for him in any and all capacities, to sign any
amendments to this report on Form 10-K, and to file the same, with exhibits
thereto and other documents in connection therewith, with the Securities and
Exchange Commission, hereby ratifying and confirming all that the said
attorney-in-fact, or his substitute or substitutes, may do or cause to be done
by virtue thereof.
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.
Signature Title Date
/s/ Samuel J. Wohlstadter Chief Executive Officer June 25, 1999
- ------------------------- (Principal Executive Officer);
Samuel J. Wohlstadter Director
/s/ George V. Migausky Vice President June 25, 1999
- ------------------------- and Chief Financial Officer
George V. Migausky (Principal Financial and
Accounting Officer)
/s/ Richard J. Massey President, Chief Operating June 25, 1999
- ------------------------- Officer; Director
Richard J. Massey
/s/ Edward Lurier Director June 25, 1999
- ------------------------
Edward Lurier
/s/ William O'Neill Director June 25, 1999
- ------------------------
William O'Neill
/s/ Robert Salsmans Director June 25, 1999
- ------------------------
Robert Salsmans
55
INDEX TO EXHIBITS
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
- ------ -----------------------
2.1(4) Agreement and Plan of Merger effective November 19, 1996 (by virtue of a
reincorporation), by and between IGEN, Inc., a California corporation (the "Company"),
and IGEN International, Inc. a Delaware corporation (the "Registrant").
3.1(4) The Registrant's Certificate of Incorporation, as filed with the Secretary of State of
the State of Delaware on August 30, 1996.
3.2(4) The Registrant's Certificate of Designation of Series A Junior Participating Preferred
Stock, as filed with the Secretary of State of the State of Delaware on November 18,
1996.
3.3(8) The Registrant's Certificate of Designation of Series B
Convertible Preferred Stock, as field with the Secretary of
State of the State of Delaware on December 18, 1997.
3.4(4) The Registrant's Bylaws, as currently in effect.
4.1(7) Form of Specimen Right Certificate.
4.2(7) Rights Agreement, dated November 6, 1996, between the Registrant and The First
National Bank of Boston.
4.3 Note Purchase Agreement between the Registrant and the purchasers named therein dated
as of March 22, 1999. Filed herewith.
10.1(1) Registration Agreement between the Registrant and the parties
named therein dated March 17, 1988, as amended through
March 30, 1993.
10.2(3) Form of Waiver and Amendment of Registration Agreement executed
in December 1993, amending in certain respects the Registration
Agreement dated as of March 17, 1988.
10.3(3) Agreement between the Registrant and The Perkin-Elmer Corporation
dated March 30, 1990, with Addendum to Agreement dated February 21,
1991 (with certain confidential information deleted).
10.4(3) Agreement between the Registrant and Eisai Co., Ltd. dated May 25,
1990 (with certain confidential information deleted).
10.4.1(1) Supplemental Agreement between Eisai Co., Ltd. and the Registrant
10.5(3) License and Development Technology Agreement between the Registrant
and Boehringer Mannheim GmbH dated September 23, 1992 (with
certain confidential information deleted).
10.5.1(2) Advanced Royalty Agreement between the Registrant and
Boehringer Mannheim GmbH dated January 9, 1997.
10.6(3) License Agreement between the Registrant and Hyperion Catalysis
International ("Hyperion") dated October 10, 1993 as amended March 15,
1990.
10.7(3) Common Stock Purchase Agreement between the Registrant and Organon
Teknika B.V. ("Organon") dated May 19, 1993.
56
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
- ------ -----------------------
10.8(3) License and Technology Development agreement between the Registrant
and Organon dated May 19, 1993 (with certain confidential information
deleted).
10.9(3) Agreement and Plan of Reorganization and Agreement and Plan of Merger
between the Registrant and Molecular Displays, Inc. dated March 9, 1993.
10.103 Term Sheet for Consolidation of Research Projects between the Registrant and
Proteinix Corporation dated December 14, 1993 (with certain confidential
information deleted).
10.11(3) Term Sheet for consolidation of Cancer Research Projects between the
Registrant and Pro-Neuron, Inc. dated December 14, 1993 (with certain
confidential information deleted).
10.12(3) Join Venture Agreement between the Registrant and Hyperion dated
May 28, 1993.
10.13(3) Product Development and Marketing Agreement between the
Registrant, Hyperion and HyperGen dated May 29, 1993.
10.14(3) Form of Indemnity Agreement entered into between the Registrant and its
directors and officers.
10.15(3) Registrant's 1985 Stock Option Plan, as amended, and related Form of
Incentive Stock Option Grant and Form of Nonqualified Stock Option Grant.
10.16(5) Registrant's 1994 Stock Option Plan, and related Form of Incentive Stock
Option Grant.
10.17(5) Registrant's 1994 Non-Employee Directors Stock Option Plan, and related
Form of Incentive Stock Option Grant.
10.18(5) Lease Agreement between the Registrant and W-M 16020 Limited
Partnership dated October 5, 1994.
10.19(5) Agreement for Purchase and Sale of Joint Venture Interest
between the Registrant and Hyperion, dated December 28, 1994
10.20(6) Joint Venture Agreement, dated as of November 30, 1995, between Meso Scale
Diagnostics, LLC ("MSD"), Meso Scale Technologies, LLC ("MST")
and the Company.
10.21(6) Limited Liability Company Agreement, dated as of November 30, 1995, between MSD, MST
and the Company.
10.22(6) IGEN/MSD License Agreement, dated as of November 30, 1995, between MSD and the Company.
10.23(6) Indemnification Agreement, dated as of November 30, 1995, between the Company and
Jacob Wohlstadter.
10.24(8) Purchase Agreement for the Series B Convertible Preferred Stock between the Registrant
and the purchasers named therein dated as of December 16, 1997.
10.25(8) Registration Rights Agreement between the Registrant and the purchasers named therein
dated as of December 16, 1997.
11.1 Calculation of net loss per share. Filed herewith.
23.1 Consent of Deloitte & Touche LLP. Filed herewith.
57
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
- ------ -----------------------
27.1 Financial Data Schedule. Filed herewith.
- ------------
(1) Previously filed as an exhibit to the Registrant's Form 10-Q for the
quarter ended September 30, 1997.
(2) Previously filed as an exhibit to the Registrant's Annual Report on Form
10-K, as amended, for the fiscal year ended March 31, 1997.
(3) Previously filed as an exhibit to the Registration Statement on Form S-1,
as amended (Registration No. 33-72992) and incorporated by reference
herein.
(4) Previously filed as an exhibit to the Registrant's Form 10-Q for the
quarter ended December 31, 1996.
(5) Previously filed as an exhibit to the Registrant's Annual Report on Form
10-K for the fiscal year ended March 31, 1995.
(6) Previously filed as an exhibit to the Registrant's Form 10-Q for the
quarter ended December 31, 1995.
(7) Incorporated by reference to Exhibit 1.1 of the Registrant's Form 8-A
filed December 10, 1996.
(8) Previously filed as an exhibit to the Registrant's Registration Statement
on Form S-3, as amended (Registration No. 333-45355).
58