1
================================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
-------------------------------
FORM 10-K
(MARK ONE)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
EXCHANGE ACT OF 1934 (NO FEE REQUIRED, EFFECTIVE OCTOBER 7, 1996) FOR
THE FISCAL YEAR ENDED DECEMBER 31, 1997
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
EXCHANGE ACT OF 1934 (NO FEE REQUIRED) FOR THE TRANSITION PERIOD
FROM ______________ TO _______________
COMMISSION FILE NUMBER 33-69586
CLINTRIALS RESEARCH INC.
(Exact name of registrant as specified in its charter)
DELAWARE 62-1406017
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification Number)
20 BURTON HILLS BOULEVARD, SUITE 500 37215
NASHVILLE, TENNESSEE (Zip Code)
(Address of principal executive offices)
(615) 665-9665
(Company'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
NAME OF EACH EXCHANGE
TITLE OF EACH CLASS ON WHICH REGISTERED
- ----------------------------- ----------------------
Common Stock, $.01 par value Nasdaq Stock Market
-------------------------------
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 requirement for the past 90 days. Yes [X] No [ ]
Indicate by check mark if disclosure of delinquent filers pursuant to
Item 405 of Regulation S-K is not contained herein, and will not be contained,
to the best of registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. [ ]
The aggregate market value of voting stock held by nonaffiliates of the
registrant was $106,462,000 as of March 16, 1998. The number of Shares of Common
Stock outstanding as of March 16, 1998 was 18,184,916.
DOCUMENTS INCORPORATED BY REFERENCE
The following documents are incorporated by reference into Part II,
Items 6, 7 and 8 of this Form 10-K: Portions of the Registrant's Annual Report
to its stockholders for fiscal year ended December 31, 1997.
The following documents are incorporated by reference into Part III,
Items 10, 11 and 12 of this Form 10-K: Portions of the Registrant's definitive
proxy materials for its 1998 Annual Meeting of stockholders.
================================================================================
2
PART I
ITEM 1. BUSINESS
ClinTrials Research Inc. (the "Company" or "ClinTrials") is a full
service contract research organization ("CRO") serving the pharmaceutical,
biotechnology and medical device industries. The Company designs, monitors and
manages preclinical and clinical trials, provides clinical data management and
biostatistical services, and offers product registration services throughout the
United States, Canada and Europe. The Company generates substantially all of its
revenue from preclinical and clinical testing of new pharmaceutical and
biotechnology products. At December 31, 1997, the Company had contracts in
backlog to perform clinical research services in multiple countries worldwide.
To date, the Company has performed services for approximately 300 clients
including the ten largest pharmaceutical companies in the world. Net service
revenue increased 8.7% to $103.0 million in 1997 from $94.7 million in 1996.
New pharmaceutical and biotechnology products must undergo extensive
testing and regulatory review to determine their relative safety and
effectiveness. Companies seeking approval for these products are responsible for
performing and analyzing the results of preclinical and multi-phase clinical
trials. Preclinical trials typically last for up to three years and involve
animal testing. Clinical trials are conducted over a period typically lasting
five to seven years and involve hundreds or thousands of human subjects. These
trials were historically performed almost exclusively by inhouse personnel at
the major pharmaceutical companies. In recent years, pharmaceutical companies
have begun to outsource clinical trials management to CROs, which has resulted
in significant growth in the CRO industry. The Company believes worldwide
research and development expenditures by the pharmaceutical and biotechnology
industries reached an estimated $36 billion in 1997, approximately $12 billion
of which was spent on preclinical and clinical trials, with approximately $3.5
billion being outsourced to CROs. Research and development expenditures in 1997
for the top 50 pharmaceutical companies in the world increased approximately 11%
from the previous year. The Company believes that certain industry trends have
led pharmaceutical and biotechnology companies to increase research and
development for proprietary new drugs, conduct increasingly complex clinical
trials, and develop multinational clinical trial capability, while seeking to
control internal fixed costs. These trends include the increased emphasis on
finding treatments for chronic disorders and infectious diseases, the desire by
manufacturers to market pharmaceutical and biotechnology products simultaneously
in several countries, and cost containment pressures from certain governments,
managed care organizations and other payors. By providing experienced clinical
and database management personnel to conduct complex trials on a contract basis,
CROs have enabled pharmaceutical and biotechnology companies to respond to cost
containment pressures by turning the fixed costs of internal research into
variable costs.
ClinTrials Research Inc. is an international research services
organization headquartered in Nashville, Tennessee, with offices in Research
Triangle Park, North Carolina; Lexington, Kentucky; Chicago, Illinois;
Maidenhead, U.K.; Glasgow, Scotland; Brussels, Belgium; Paris, France;
Melbourne, Australia; Jerusalem, Israel; Milan, Italy; Santiago, Chile; and
Montreal, Canada.
BACKGROUND
New Drug Development -- An Overview. Before a new drug may be marketed,
it must generally undergo extensive testing and regulatory review to determine
that it is safe and effective. This development process consists of two stages,
preclinical and clinical. In the preclinical stage, the sponsor of the new drug
conducts laboratory analyses and animal tests, generally over a one to three
year period, to determine the basic biological activity and safety of the drug.
Upon successful completion of the preclinical phase, the drug undergoes a series
of clinical tests in humans, including healthy volunteers as well as patients
with the targeted disease, generally over a five to seven year period. In the
United States, preclinical and clinical testing must comply with the
requirements of Good Clinical Practice ("GCP") and other standards promulgated
by the Food and Drug Administration (the "FDA") and other federal and state
governmental authorities. GCP stipulates procedures designed to ensure the
quality and integrity of data obtained from clinical testing and to protect the
rights and safety of clinical subjects. The FDA pioneered the use of clinical
trials in the regulation of new drug development, and the agency's approval
process has shaped much drug regulation worldwide. In recent years, the FDA and
corresponding regulatory agencies of the major industrial countries (Canada,
Japan and the European Community ("EC")) commenced discussions for the purpose
of developing common standards for both the conduct of preclinical and clinical
1
3
studies and the format and content of applications for new drug approvals. Data
from multi-national studies adhering to GCP are now generally acceptable to the
FDA and the governments within the EC.
In the United States, a drug sponsor must file an Investigational New
Drug Application ("IND") with the FDA before the commencement of human testing
of a drug. The IND includes preclinical testing results and sets forth the
sponsor's plans for conducting human clinical trials. The design of these plans,
also referred to as the study protocol, is critical to the success of the drug
development effort because the protocol must correctly anticipate the data and
results that the FDA will require before approving the drug. In the absence of
any comments from the FDA, human clinical trials may begin 30 days after the IND
is filed.
Clinical trials usually start on a small scale to assess safety and
then expand to larger trials to test efficacy. Trials are usually grouped into
four phases, with multiple trials generally conducted within each phase.
Phase I. Phase I trials are conducted on healthy volunteers,
typically 20 to 80 persons, to develop basic safety data relating to
toxicity, metabolism, absorption and other pharmacological actions.
These trials last an average of six months to one year.
Phase II. Phase II trials are conducted on a small number of
subjects, typically 100 to 400 patients, who suffer from the drug's
targeted disease or condition. Phase II trials offer the first evidence
of clinical efficacy, as well as additional safety data. These trials
last an average of two years.
Phase III. Phase III trials are conducted on a significantly
larger population of several hundred to several thousand patients, some
of whom suffer from the targeted disease or condition and some of whom
are healthy. Phase III trials are designed to measure efficacy on a
large scale as well as long-term side effects. These trials involve
numerous sites and generally last two to three years.
Phase IV. As a condition of granting marketing approval, the
FDA may require that a sponsor continue to conduct additional clinical
trials, known as Phase IV trials, to monitor long-term risks and
benefits, study different dosage levels, or evaluate different safety
and efficacy parameters in target patient populations. With the
increasing importance of Phase IV trials has also come increased
complexity in the scope of the trials (i.e., the number of patients
tested) and the manner in which they are conducted (i.e., the number of
sites at which testing is performed). Phase IV trials generally last
one to four years.
Clinical trials often represent the most expensive and time-consuming
part of the overall drug development process. The information generated during
these trials is critical for gaining marketing approval from the FDA or other
regulatory agencies. After the successful completion of Phase III trials, the
sponsor of a new drug must submit a New Drug Application ("NDA") to the FDA. The
NDA is a comprehensive filing that includes, among other things, the results of
all preclinical and clinical studies, information about the drug's composition
and the sponsor's plans for producing, packaging and labeling the drug. Most of
the clinical data contained in an NDA is generated during the Phase II and III
trials. The FDA's review of an NDA can last from several months to several
years, with the average review lasting two years. Drugs that successfully
complete this review may be marketed in the United States, subject to the
conditions imposed by the FDA in its approval. The FDA has been subject to
increasing pressure to allow drugs to reach the public more quickly. As a
result, in some instances the FDA has expedited the review process by granting
conditional approval of lifesaving drugs or those for conditions for which there
is no current treatment so that they can be marketed while Phase IV trials are
being conducted. In recent years, the FDA has encouraged the use of computer
assisted NDAs ("CANDAs") in an effort to expedite the approval process.
INDUSTRY TRENDS
The contract research industry derives substantially all of its revenue
from the research and development ("R&D") expenditures of pharmaceutical,
biotechnology and medical device companies. The Company believes that certain
industry trends have led pharmaceutical and biotechnology companies to increase
the use of CROs for preclinical and clinical trials. These trends include the
following:
2
4
Increasing Cost Containment Pressures. The increasing pressure to
control rising health care costs, and the penetration of managed health care and
health care reform have caused the following changes in the pharmaceutical
industry:
- Managed Care Organizations. Managed care organizations have
become major participants in the delivery of pharmaceuticals.
These organizations limit the selection of drugs from which
affiliated physicians may prescribe, thus increasing the
competition among pharmaceutical companies to develop more
effective products in a shorter time frame.
- Consolidation. As pharmaceutical companies seek to create
economies of scale, there have been several large mergers
within the pharmaceutical industry, and as a result of these
mergers, the pharmaceutical industry has experienced large
scale employee lay-offs and other cutbacks.
- Other Factors. Factors such as competition from generic drugs
following patent expiration, more stringent regulatory
requirements and the increasing complexity of clinical trials
have resulted in increasing market pressure on profit margins.
In response to these cost containment pressures, a number of United
States pharmaceutical companies have publicly committed to hold net effective
price increases generally in line with inflation. In the area of clinical
development, many pharmaceutical and biotechnology companies are seeking to
reduce the high fixed costs associated with peak-load staffing by reducing
internal clinical staff and relying on a combination of internal resources and
external resources such as CROs, thereby shifting fixed costs to variable costs.
Globalization of Clinical Research and Development. Due to the
increasing cost of new drug development, many projects that are not expected to
achieve sufficient annual worldwide revenue are abandoned. Pharmaceutical
companies are increasingly attempting to maximize returns from a given drug by
pursuing regulatory approvals in multiple countries simultaneously rather than
sequentially. A pharmaceutical company seeking approval in a country in which it
lacks experience or internal resources will frequently turn to a CRO for
assistance in interacting with regulators or in organizing and conducting
clinical trials. The Company believes that the globalization of clinical
research and development activities has increased the demand for CRO services.
Increasingly Complex and Stringent Regulation; Need for Technological
Capabilities. Increasingly complex and stringent regulatory requirements
throughout the world have increased the volume of data required for regulatory
filings and escalated the demand for data collection and analysis during the
drug development process. Additionally, in the five years ended 1992, the
average number of clinical trials per new drug application approximately
doubled, and the average number of patients participating in those trials
increased approximately 25%. In recent years, the FDA and corresponding
regulatory agencies of Canada, Japan and the EC have commenced discussions to
develop common standards for preclinical and clinical studies and the format and
content of applications for new drug approvals. Further, the FDA encourages the
use of computer-assisted filings in an effort to expedite the approval process.
As regulatory requirements have become more complex, the pharmaceutical and
biotechnology industries are increasingly outsourcing to CROs to take advantage
of their data management expertise, technological capabilities and global
presence.
Escalating Research and Development Expenditures. Research and
development expenditures in 1997 for the top 50 pharmaceutical companies in the
world (as measured by such expenditures) increased approximately 11% from the
previous year. Such expenditures have resulted from an increased emphasis on
developing effective products for the treatment of chronic disorders and life
threatening acute conditions such as infectious diseases. The cost of developing
therapies for chronic disorders, such as arthritis, Alzheimer's disease and
osteoporosis is higher because the treatments must be studied for a longer
period to demonstrate their effectiveness in curbing the chronic disorder and to
determine any possible long-term side effects.
3
5
Reducing Drug Development Time Requirements. Pharmaceutical and
biotechnology companies face increased pressure to bring new drugs to market in
the shortest possible time, thereby reducing costs, maintaining market share and
accelerating realization of revenue. Currently, total development of a new drug
takes approximately eight to twelve years, a significant portion of a drug's
seventeen-year period for protection under United States patent laws. Certain
clients of the Company have initiated plans to reduce this time to approximately
five to seven years. Pharmaceutical and biotechnology companies are attempting
to increase the speed of new product development, and thereby maximize the
period of marketing exclusivity and economic returns for their products, by
outsourcing development activities to CROs. The Company believes that CROs are
often able to perform the needed services with a higher level of expertise or
specialization, and more quickly, than a pharmaceutical or biotechnology company
could perform such services internally. In addition, some pharmaceutical and
biotechnology companies are beginning to contract with large full-service CROs
to conduct preclinical and all phases of clinical trials for new product
programs lasting several years, rather than separately contracting specific
phases of drug development to several different CROs. The Company believes this
approach may result in shorter overall development times. In anticipation of
this trend, the Company has established itself as a firm capable of taking a
pharmaceutical from its initial testing through its licensing for
commercialization.
New Drug Development Pressures. The Company believes that R&D
expenditures have increased as a result of the constant pressure to develop and
patent products, and to respond to the demand for products for an aging
population and for the treatment of chronic disorders and life-threatening
conditions. In response to this pressure, pharmaceutical and biotechnology
companies are outsourcing preclinical and clinical trials in order to use their
own resources to develop additional drugs.
Growth of Biotechnology Industry. The biotechnology industry and the
number of drugs produced by it which require FDA approval have grown
substantially over the past decade. Many biotechnology companies have chosen not
to expend resources to develop sufficient staff or expertise to conduct clinical
trials in-house, but rather have utilized providers such as CROs to perform
these services.
As the use of CROs increases, so do the demands placed upon CROs like
ClinTrials that provide a broad range of services in multiple countries for
larger clients. For example, larger CROs generally remain competitive by
sustaining internal growth and by opening offices in additional countries in
order to have a presence near either a client or a large test site.
Increasingly, large clients require CROs to meet certain credit-worthiness
standards. As a result of these factors, CROs such as ClinTrials have
experienced an increasing demand for working capital and strong balance sheets
in order to maintain their competitive standing within the industry.
BUSINESS STRATEGY
The trend toward outsourcing the clinical testing process for
pharmaceutical, biotechnology and medical device products is accelerating. The
CRO industry is highly fragmented with many small, limited-service providers as
well as in-house research departments, universities and teaching hospitals, and
other CROs, many of which have substantially greater resources than the Company.
However, the Company believes it is well positioned to take advantage of the
trend toward outsourcing as a result of its demonstrated ability to provide a
broad range of professional, cost-effective clinical research and development
services worldwide. The Company's strategy is comprised of the following
elements:
Provide Comprehensive Preclinical and Clinical Research Services. The
Company offers a broad range of clinical research services and believes that its
knowledge and experience in all stages of clinical research enhance its
credibility with prospective clients. The Company has the capability to provide
a full range of preclinical and clinical services on a turnkey basis, which the
Company believes can be especially important to clients without significant
relevant regulatory expertise, such as biotechnology companies and international
pharmaceutical companies seeking to enter new geographic markets. To meet the
needs of specific clients, the Company offers its services separately or as an
integrated package. This allows a client to use the Company to design a
protocol, conduct a trial, analyze the results of one or more trials, prepare
and submit a new drug application or computer-assisted filing to the FDA, or for
any combination of these services. This approach enables the Company to respond
to clients' requirements with flexibility and also allows it to establish a
relationship with a new client with a particular service that may in turn lead
to larger, more comprehensive projects. In addition, the Company believes its
preclinical capabilities will increase the prospect of being awarded contracts
for later stage testing after satisfactory completion of the preclinical tests.
4
6
Pursue Strategic Alliances. In these arrangements, the client agrees to
provide the Company with a minimum level of volume and is guaranteed adequate
staffing over a multi-year period. The Company believes this type of arrangement
results in more predictable pricing to the client and more efficient management
of the Company's resources, and potentially increases the amount of work
outsourced to the Company by the strategic partner. In the past three years, the
Company has entered into strategic alliances with Baxter Healthcare Corporation,
Novartis Pharmaceuticals Corporation, SmithKline Beecham Corporation and Glaxo
Wellcome. In addition, the Company's preclinical subsidiary has "preferred
provider" relationships, which, in contrast to strategic alliances, are
noncontractual, informal relationships in which the client makes the Company
among its first choices of testing service providers.
Expand International Presence. The Company provides clinical research
and development services to major United States and European pharmaceutical and
biotechnology companies. The Company conducts multi-national clinical trials
designed to pursue concurrent regulatory approvals in multiple countries. The
Company believes that this experience is a competitive advantage, as
pharmaceutical and biotechnology companies increasingly are pursuing regulatory
approvals simultaneously in multiple countries. The Company has recently
increased its European management team and added a data management facility in
Glasgow, Scotland to provide more comprehensive services to its United States
clients doing business abroad and to better market its services to existing and
potential European clients. During 1996, the Company expanded its geographic
reach by opening trials management offices in Australia, France, Israel and
Chile, and has delivered services in over 30 countries.
Develop Capabilities in Emerging Areas. The Company attempts to
establish study protocols and expertise in a therapeutic area prior to the
formal announcement of a new product by a pharmaceutical or biotechnology
company. Manufacturers prefer to outsource to CROs that already have knowledge
and have developed testing models in the relevant area and that can therefore
more quickly begin the new drug application process. The Company learns of
promising research and potential new products by attending conferences, reading
scientific literature and by networking with industry experts, academics,
manufacturers' representatives and others.
Invest in Information Systems Technology. The Company maintains a
commitment to investment in technology with a focus on management information
systems. The Company has invested heavily in improving its standard operating
procedures, in continuous reengineering of the workflow processes and in the
infrastructure required to support the creation, maintenance and statistical
analysis of highly sophisticated databases. 1996 information systems investments
expanded the Company's capacity to process data in a standard unified format and
1997's investments provided value added software which expedited the delivery
process for data and enabled real time integrated interpretation of multiple
complex data sets. Information technology tools currently being utilized include
(i) an integrated voice response system which allows investigators to enroll
patients into a trial, control drug utilization and distribution and have access
to patient diary information through use of a touch tone telephone, (ii)
clinical integrated data review tools which enable the sponsor to have real time
access to data sets in order to create statisical data sets and graphs based
upon patient selection criteria, (iii) an automated facsimile system which
allows investigators to fax a patient Case Report Form ("CRF") directly into the
Company's system and thus expedite data collection and processing and (iv) a
clinical trial management system which integrates various levels of the trial
process to provide a real time review of the full clinical study cycle from
protocol creation to database lock. The Company intends to continue to improve
its management information systems with significant capital expenditures
anticipated in 1998.
Broaden Therapeutic Expertise. Prior working knowledge in specific
therapeutic areas is a highly valued criterion by which many decisions to work
with a CRO are made. ClinTrials has experience in a broad range of therapeutic
areas and is continuing to expand its ability and experience in more therapeutic
areas. ClinTrials has demonstrated depth and high quality performance in the
following areas: anti-viral and other infectious diseases, cardiology, central
nervous system, gastroenterology, endocrinology, respiratory and urology,
osteoporosis evaluation, cardiovascular pharmacology, biomaterials testing,
bio-marker assays and infusion delivery. The Company is a leader in the
investigation of blood substitutes and protease inhibitors and in the conducting
of megatrials (trials involving more than 1,000 participants).
Increase Client Base and Number of Contracts. ClinTrials' strategy is
to seek contracts with new clients and new contracts with existing clients in
different therapeutic areas and to cross-sell other services to existing
clients.
Pursue Selected Acquisitions. The Company plans to pursue strategic
acquisitions of selected CROs or related businesses that provide one or more of
the following: complementary services, expanded geographic presence, new
therapeutic expertise or complementary client bases.
5
7
SERVICES
The Company's services and related products include preclinical and
clinical trials management services, clinical data management and biostatistical
services, and product registration services. The Company's services can be
provided separately or as an integrated package. Services from each of these
categories can be utilized for the development and execution of a turnkey NDA.
Preclinical Trials. The Company designs and conducts preclinical
research programs, based principally upon animal models, that generate the data
required to establish safe starting dosages and the potential efficacy of a
product in humans, and to determine organ toxicity and other potential risks of
human usage. Preclinical trial reports are submitted to regulatory authorities
in support of an application to initiate clinical testing in humans. The Company
also offers analytical laboratory services including assessment of product
concentration in suspensions, solutions, animal feed and plasma radiometric
determination in metabolite profiling of biological tissues, and radiopurity
assessment of dose solution.
Clinical Trials Management Services. The Company offers complete
services for the design, placement, performance and management of clinical trial
programs, a critical element in obtaining regulatory approval for drugs and
medical devices. The Company has performed services in connection with trials in
many therapeutic areas. The Company's multi-disciplinary clinical trials group
has the ability to examine a product's existing preclinical and clinical data
for the purposes of designing protocols for clinical trials in order to
ascertain evidence of the product's safety and efficacy.
The Company manages every aspect of trials in Phases I through IV,
including design of operations manuals, identification and recruitment of trial
investigators, initiation of sites, monitoring for strict adherence to GCP, site
visits to ensure compliance with protocol procedures and proper collection of
data, interpretation of trial results and report preparation. Substantially all
of the Company's current clinical projects involve Phase II, III or IV clinical
trials, which, in most cases, are significantly larger and more complex than
Phase I trials.
In the CRO industry, trials involving tests on over 1,000 patients over
a period of several years at multiple sites are becoming more routine. These
trials have resulted from the drug companies' emphasis on treating and curing
chronic disorders and the resulting need to thoroughly test large numbers of
patients for long-term side effects of new drugs. The Company is experienced in
managing such trials and actively markets its abilities in this area.
Clinical trials are monitored for strict adherence to GCP. Efficient
data collection, form design, detailed operations manuals and site visits by the
Company's clinical research associates ("CRA") are employed to determine whether
clinical investigators and their staffs follow established protocols and
accurately record the findings of the trials.
The Company assists clients with one or more of the following steps of
clinical trials:
- Study Protocol. The protocol defines the medical issues the study
seeks to examine and the statistical tests that will be conducted.
Accordingly, the protocol defines: (i) the frequency and type of
laboratory and clinical measures that are to be tracked and analyzed;
(ii) the number of patients required to produce a statistically valid
result; (iii) the period of time over which they must be tracked; and
(iv) the frequency and dosage of drug administration.
- Case Report Forms. Once the study protocol has been finalized,
special forms for recording the desired information must be
developed. These forms are called Case Report Forms ("CRFs"). The CRF
may change at different stages of a trial. The CRF for one patient in
a given study may consist of as many as 100 pages or more.
- Site and Investigator Recruitment. The drug is administered to
patients by investigators, at hospitals, clinics or other locations,
referred to as sites. Potential investigators may be identified by
the drug sponsor or the CRO, which then solicits the investigators'
participation in the study. Generally, the investigators contract
directly with the Company. The trial's success depends on the
successful identification and recruitment of investigators with
proper expertise and an adequate base of patients who satisfy the
requirements of the study protocol.
6
8
- Patient Enrollment. The investigators find and enroll patients
suitable for the study according to the study protocol. Prospective
patients are required to review information about the drug and its
possible side effects and sign an informed consent to record their
knowledge and acceptance of potential side effects. Patients also
undergo a medical examination to determine whether they meet the
requirements of the study protocol. Patients then receive the drug
and are examined by the investigator as specified by the study
protocol.
- Study Monitoring and Data Collection. As patients are examined and
tests are conducted in accordance with the study protocol, data are
recorded on CRFs and laboratory reports. The data are collected from
study sites by specially trained CRAs. CRAs visit sites regularly to
ensure that the CRFs are completed correctly and that all data
specified in the protocol are collected. CRFs are reviewed for
consistency and accuracy before their data are entered into an
electronic database.
- Medical Affairs. Throughout the course of a clinical trial, the
Company may provide various medical research and services including
medical monitoring of clinical trials, interpretation of clinical
trial results and preparation of clinical study reports.
- Report Writing. The results of statistical analysis of data collected
during the trial together with other clinical data are included in a
final report generated for inclusion in a regulatory document.
Clinical Data Management and Biostatistical Services. The Company's
data management professionals assist in the design of protocols and CRFs, as
well as training manuals and training sessions for investigational staff, to
ensure that data are collected in an organized and consistent format. Databases
are designed according to the analytical specifications of the project and the
particular needs of the client. Prior to data entry, the Company's personnel
screen the data to detect errors, omissions and other deficiencies in completed
CRFs. The Company provides clients with data abstraction, data review and
coding, data entry, database verification and editing, and problem data
resolution.
The Company's biostatistics professionals provide biostatistical
consulting, database design, data analysis and statistical reporting. The
Company's biostatisticians provide clients with assistance in all phases of drug
development. These professionals develop and review protocols, design
appropriate analysis plans and design report formats to address the objectives
of the study protocol as well as the client's individual objectives. Working
with the programming staff, biostatisticians perform appropriate analyses and
produce tables, graphs, listings and other applicable displays of results
according to the analysis plan. Additionally, biostatisticians assist clients
before panel hearings at the FDA.
The Company believes that its data management and biostatistical
services capabilities can be utilized by a client more effectively when packaged
as part of its total clinical trials management services and used to monitor
Phases I through IV rather than just one phase. This packaging permits
technology transfer resulting in a faster and less costly clinical trial
process, as the data are collected and analyzed more rapidly and the decision to
move to the next phase can be made more quickly.
Product Registration Services. The Company provides comprehensive
product registration services throughout Europe and the United States. The
Company provides regulatory strategy formulation, document preparation, Good
Manufacturing Practice consultation and acts as liaison with the FDA and other
regulatory agencies. Although these services have not generated material revenue
to date, the Company offers these services in order to provide the full range of
services necessary to remain competitive in the CRO industry.
The Company works closely with clients to devise regulatory strategies
and comprehensive product development programs. The Company's regulatory affairs
experts review existing published literature, assess the scientific background
of a product, assess the competitive and regulatory environment, identify
deficiencies and define the steps necessary to obtain registration in the most
expeditious manner. Through this service, the Company helps its clients
determine the feasibility of developing a particular product or product line.
7
9
The Company's regulatory affairs professionals have experience in the
analysis, preparation and submission of FDA regulatory documents covering a wide
range of products, including drugs and over-the-counter products. The Company
also has experience with preparing regulatory documentation for submission to
European regulatory authorities.
Pharmacoeconomic Services. The Company now provides enhanced
pharmacoeconomic and registry services through its merger in June 1997 with
Chicago-based Ovation Healthcare. Such services are growing increasingly
important for determining economic and quality of life factors in the total cost
and outcomes of many diseases.
CLIENTS AND MARKETING
The Company has served many of the leading pharmaceutical companies in
the United States and the EC. The Company's clients include the ten largest
pharmaceutical companies in the world. The Company's clients also include
companies in the biotechnology and medical device industries. For the year ended
December 31, 1997, the Company recognized revenue on contracts with 194 clients.
During 1997, approximately 75% of the Company's net service revenue was derived
from pharmaceutical companies, 23% from biotechnology companies and 2% from
medical device companies. In 1996, such companies contributed 83%, 15% and 2%
of net service revenue, respectively.
The Company has had, and will continue to have, certain clients from
which at least 10% of the Company's overall revenue is generated over multiple
contracts. Such concentrations of business are not uncommon within the CRO
industry. During 1997, the Company generated approximately 13% of its net
service revenue from multiple contracts with a major pharmaceutical company. No
other client represented 10% or more of the Company's net revenue in 1997. The
Company's contracts are entered into with numerous therapeutic areas or
divisions within each client and frequently involve different decision makers.
Thus, there is a reduced likelihood that the Company would simultaneously lose
all contracts with any single client.
Marketing activities are conducted by the Company's business
development personnel based in each of the Company's locations. In response to
the highly technical nature of the Company's business, most business development
personnel have scientific backgrounds. Additionally, the Company runs an
extensive advertising program in trade journals and publications and, from time
to time, employs direct mailings of information to existing and potential
clients. The Company also attends and exhibits at selected trade shows in the
United States and Europe.
CONTRACTUAL ARRANGEMENTS
The Company generally is awarded contracts based, among other things,
upon its response to requests for proposal ("RFP") received from pharmaceutical,
biotechnology and medical device companies. The contract may require the Company
to design a protocol, conduct the trial, analyze the results of one or more of
the trials, prepare and submit an IND, NDA or CANDA to the FDA, or perform any
combination of these services. After negotiating a letter of intent or
definitive contract for clinical studies, the Company, and in many cases the
client, will coordinate the selection of clinical investigators and conduct
pre-study site visits. The clinical investigators, in conjunction with the
Company, are then responsible for enrolling participants in the trial, which may
include persons with a given disorder or disease, healthy persons and persons
within defined populations. Informed consents, in accordance with FDA and
institutional regulations, are obtained from all participants. Change orders to
existing contracts are typically generated at the request of the client based on
the results of the trial to date and include changes in the scope of the trial
and in the services to be provided by the Company. The Company may record
additional revenue or reduce backlog as a result of change orders.
Most contracts are fixed priced, multi-year contracts that require a
portion of the contract amount to be paid at or near the time the trial is
initiated. The Company generally bills its clients upon the completion of
negotiated performance requirements and, to a lesser extent, on a date certain
basis. The Company's contracts generally may be terminated with or without
cause. In the event of termination, the Company is typically entitled to all
sums owed for work performed though the notice of termination and all costs
associated with termination of the study. In addition, some of the Company's
contracts provide for an early termination fee, the amount of which usually
declines as the trial progresses. Termination or delay in the performance of a
contract occurs for various reasons, including, but not limited to, unexpected
or undesired results, inadequate patient enrollment or investigator recruitment,
8
10
production problems resulting in shortages of the drug, adverse patient
reactions to the drug, or the client's decision to deemphasize a particular
trial.
The Company's strategic alliance agreements, although larger in size
and covering several projects over multiple years, are generally the same as the
contracts described above.
BACKLOG
Backlog consists of anticipated net service revenue from letters of
intent and contracts that have not been completed. Once work under a letter of
intent or contract commences, net service revenue is recognized over the life of
the contract using the percentage-of-completion method of accounting. Since it
is common for clients to authorize projects and the Company to commence
providing services before a contract is signed, the Company believes reported
backlog should consist of anticipated net revenue from uncompleted projects
which have been authorized by a client, through a written contract or otherwise.
At December 31, 1995, 1996 and 1997, the Company's backlog was $90.2 million,
$140.7 million and $101.3 million, respectively. The decrease in backlog is
primarily attributable to the cancellations of contracts aggregating
approximately $37 million in backlog which occurred in the fourth quarter of
1996 and first quarter of 1997. None of the cancellations were related to
service or quality problems. The Company believes that backlog is not a
consistent indicator of future results because backlog can be affected by a
number of factors, including the variable size and duration of projects, many of
which are performed over several years. Additionally, projects may be terminated
by the client or delayed by regulatory authorities for many reasons, including
unexpected test results. Moreover, the scope of a project can change during the
course of a study.
COMPETITION
The Company competes primarily against pharmaceutical companies' own
in-house research departments, other CROs, universities and teaching hospitals.
The CRO industry is still fragmented, with approximately 20 full-service CROs
and many small, limited-service providers. In recent years, several large,
full-service competitors have emerged, some of which have substantially greater
capital and other resources, are better known and have more experienced
personnel than the Company. The Company's largest competitors include Covance
(formerly a division of Corning, Inc.), PPD Pharmaco, Inc., Parexel
International Corp., and Quintiles Transnational Corp. The recent trend toward
industry consolidation is likely to result in heightened competition among the
larger CROs. The larger CROs are increasingly required to have substantial
amounts of working capital in order to sustain internal growth and international
expansion, and to meet the credit-worthiness standards of their larger clients.
The Company believes that clients choose a CRO based on several factors, the
most important of which is the quality of the work performed for existing
clients. Other important factors include references from existing clients,
trials management experience in and scientific knowledge of specific therapeutic
areas, the price for the services performed, the ability to organize and manage
large-scale trials on a global basis, the ability to manage large and complex
medical databases, and the ability to hire and retain qualified investigators.
The Company believes that it competes favorably in these areas.
GOVERNMENT REGULATION
The clinical investigation of new pharmaceutical, biotechnology and
medical device products is highly regulated by governmental agencies. The
purpose of United States federal regulations is to ensure that only those
products which have been proven to be safe and effective are made available to
the public. The FDA has set forth regulations and guidelines that pertain to
applications to initiate trials of products, approval and conduct of studies,
report and record retention, informed consent, applications for the approval of
new products, and post-marketing requirements. Pursuant to FDA regulations, CROs
that assume obligations of a drug sponsor are required to comply with applicable
FDA regulations and are subject to regulatory action for failure to comply with
such regulations. In the United States, the historical trend has been in the
direction of increased regulation by the FDA. The Company believes that many
pharmaceutical, biotechnology and medical device companies do not have the staff
and/or the available expertise to comply with all of the regulations and
standards, and this has contributed and will continue to contribute to the
growth of the CRO industry.
9
11
The services provided by the Company are ultimately subject to FDA
regulation in the United States and comparable agencies in other countries,
although the level of applicable regulation in other countries is generally less
comprehensive than regulation present in the United States. The Company is
obligated to comply with FDA regulations governing such activities as selecting
qualified investigators, obtaining required forms from investigators, verifying
that patient informed consent is obtained, monitoring the validity and accuracy
of data, verifying drug/device accountability, and instructing investigators to
maintain records and reports. The Company must also maintain records for each
study for specified periods for inspection by the study sponsor and the FDA
during audits. If such audits document that the Company has failed to adequately
comply with Federal regulations and guidelines, it could have a material adverse
effect on the Company. In addition, the Company's failure to comply with
applicable regulations could possibly result in termination of ongoing research
or the disqualification of data, either of which could also have a material
adverse effect on the Company, including, without limitation, damage to the
Company's reputation.
POTENTIAL LIABILITY AND INSURANCE
The Company monitors the testing of new drugs on human volunteers
pursuant to study protocols in clinical trials. Clinical research involves a
risk of liability for personal injury or death to patients from adverse
reactions to the study drug, many of whom are seriously ill and are a great risk
of further illness or death as a result of factors other than their
participation in a trial. Additionally, although the Company's employees do not
have direct contact with the participants in a clinical trial, the Company, on
behalf of its clients, contracts with physicians who render professional
services, including the administration of the substance being tested, to such
persons. As a result, the Company could be held liable for bodily injury, death,
pain and suffering, loss of consortium, other personal injury claims and medical
expenses arising from any professional malpractice of such physicians. The
Company maintains insurance to cover malpractice liability of physicians who are
employees or consultants of the Company. To date, the Company has not received
any claims resulting from either the testing of new drugs or professional
malpractice.
The Company believes that the risk of liability to patients in clinical
trials is mitigated by various regulatory requirements, including the role of
institutional review boards ("IRBs") and the need to obtain each patient's
informed consent. The FDA requires each human clinical trial to be reviewed and
approved by the IRB at each study site. An IRB is an independent committee that
includes both medical and non-medical personnel and is obligated to protect the
interests of patients enrolled in the trial. After the trial begins, the IRB
monitors the protocol and the measures designed to protect patients, such as the
requirement to obtain informed consent.
To reduce its potential liability, the Company seeks to obtain
indemnity provisions in its contracts with clients and, in some cases, with
investigators contracted by the Company on behalf of its clients. These
indemnities generally do not, however, protect the Company against certain of
its own actions such as those involving negligence or misconduct. Moreover,
these indemnities are contractual arrangements that are subject to negotiation
with individual clients, and the terms and scope of such indemnities vary from
client to client and from trial to trial. The Company also, in some
circumstances, indemnifies and holds harmless its clients and investigators
against liabilities incurred by such parties due to the actions or inactions of
the Company. Finally, since the financial performance of these indemnities is
not secured, the Company bears the risk that an indemnifying party may not have
the financial ability to fulfill its indemnification obligations. The Company
could be materially and adversely affected if it were required to pay damages or
incur defense costs in connection with a claim that is outside the scope of an
indemnity or where the indemnity, although applicable, is not performed in
accordance with its terms.
The Company currently maintains an errors and omissions professional
liabilities insurance policy in amounts it believes to be sufficient. There can
be no assurance that this insurance coverage will be adequate, or that insurance
coverage will continue to be available on terms acceptable to the Company.
INTELLECTUAL PROPERTY
The Company believes that factors such as its ability to attract and
retain highly-skilled professional and technical employees and its project
management skills and experience are significantly more important to its
performance than are any intellectual property rights developed by it. The
Company has developed, and continually develops and updates, certain computer
software related methodologies. The Company seeks to maintain its rights in the
software it develops through a combination of contract, copyright and
10
12
trade secret protection. While the Company does not consider any of this
software or methodology to be material to the Company's business, the Company
believes its software capabilities provide important benefits to its clients.
EMPLOYEES
At December 31, 1997, the Company had approximately 1500 employees and
contractors, of which 53 held Ph.D. or M.D. degree, 12 held D.V.M. degrees and
123 others held masters degrees. Approximately 40% of the Company's employees
are located in the United States, 42% are located in Canada and the remaining
18% are located in Europe. The Company believes that its relations with its
employees are good.
The Company's performance depends on its ability to attract and retain
a qualified management, professional, scientific and technical staff.
Competition from both the Company's clients and competitors for skilled
personnel is high. While the Company has not experienced any significant
problems in attracting or retaining qualified staff to date, there can be no
assurance the Company will be able to avoid these problems in the future.
RISK FACTORS
Information contained or incorporated by reference in this Form 10-K
may contain "forward-looking statements". The following matters constitute
cautionary statements identifying important factors with respect to any such
forward-looking statements, including certain risks and uncertainties, that
could cause actual results to differ materially from those reflected in any such
forward-looking statements.
Fluctuation in Quarterly Operating Results. The Company's quarterly
operating results have fluctuated as a result of factors such as delays
experienced in implementing or completing particular clinical trials,
termination of clinical trials and the costs associated with integrating
acquired operations. Since a high percentage of the Company's operating costs
are relatively fixed while revenue recognition is subject to fluctuation, minor
variations in the timing of contracts or the progress of trials may cause
significant variations in quarterly operating results. Results of one quarter
are not necessarily indicative of results for the next quarter.
Dependence on Certain Industries and Clients. The Company provides
services primarily to the pharmaceutical and biotechnology industries.
Accordingly, the Company's net service revenue is substantially dependent on
these industries' expenditures on research and development. Although these
expenditures are large, the number of potential CRO clients is relatively
limited and it is not uncommon for a CRO to derive over 10% of its revenue from
multiple contracts with a single client. The Company has in the past derived and
may in the future derive a significant portion of its net service revenue from a
relatively limited number of clients. The loss of any such client could
materially adversely affect the Company's results of operations. In 1997, one
client accounted for approximately 13% of the Company's net service revenue. No
other client accounted for more than 10% of the Company's net service revenue
during 1997. The Company's operations could be materially and adversely affected
by, among other factors, any economic downturn in the pharmaceutical or
biotechnology industries, any decrease in their research and development
expenditures, or a change in the governmental regulations pursuant to which
these industries operate. Furthermore, management believes that the Company has
benefitted to date from the increasing tendency of pharmaceutical and
biotechnology companies to outsource the performance and analysis of large
clinical research projects to independent parties. Should this tendency be
reduced or halted entirely, the Company's operations would be materially and
adversely affected.
11
13
Loss of Clinical Research Contracts. Clients of the Company generally
have the right to terminate a contract at any time during a clinical trial,
potentially causing periods of excess capacity and reductions in net service
revenue and net income. Trials may be terminated for various reasons, including
unexpected or undesired results, inadequate patient enrollment or investigator
recruitment, production problems resulting in shortages of the drug, adverse
patient reactions to the drug or the client's decision to de-emphasize a
particular trial. The termination of any one trial would typically not have a
material adverse impact on the Company. The loss of a large trial or the
simultaneous loss of multiple trials, however, could result in unplanned periods
of excess capacity and adversely affect the Company's backlog, future revenue
and profitability. In most instances, if a contract is terminated, the Company
is entitled to receive revenue earned to date as well as, at times, a
termination fee. However, because the Company's contracts are predominately
fixed price contracts, the Company bears the risk of cost overruns.
Health Care Industry Reform. The health care industry is subject to
changing political, economic and regulatory influences that may affect the
pharmaceutical and biotechnology industries. In recent years, several
comprehensive health care reform proposals were introduced in the United States
Congress. The intent of the proposals was, generally, to expand health care
coverage for the uninsured and reduce the growth of total health care
expenditures. While none of the proposals were adopted, health care reform may
again be addressed by the United States Congress. In addition, foreign
governments may also undertake health care reforms in their respective
countries. Implementation of government health care reform may adversely affect
research and development expenditures by pharmaceutical and biotechnology
companies, which could decrease the business opportunities available to the
Company. The Company is unable to predict the likelihood of such or similar
legislation being enacted into law or the effect such legislation would have on
the Company.
Exchange Rate Fluctuations. The Company conducts business in several
foreign countries and as a result exposure exists to potentially adverse
movement in foreign currency rates. The Company uses foreign exchange contracts
to hedge the risk of changes in foreign currency exchange rates associated with
contracts in which the expenses for providing services are incurred in one
currency and paid for by the client in another currency. The objective of these
contracts is to reduce the effect of foreign exchange rate fluctuations on the
Company's operating results.
No Assurance of Successful Integration of Acquisitions. A significant
component of the Company's historical growth has come through acquisitions of
other CROs, and the Company's growth strategy includes possible additional
acquisitions. Any acquisitions which the Company may pursue will involve risks,
including the possible inability to integrate the operations and services of the
acquired business, the expenses incurred in connection with the acquisition, the
diversion of management's attention from other business concerns and the
potential loss of key employees of the acquired business. Acquisitions of
foreign companies also may involve the additional risks of, among others,
integration of foreign business practices and overcoming language barriers.
There can be no assurance that any such acquisitions will not have a material
adverse effect upon the Company's results of operations, financial condition or
business prospects.
12
14
Volatility of Stock Market Price. From time to time, there may be
significant volatility in the market price for the Company's Common Stock. If
revenues, earnings or new contract orders fail to meet expectations of the
investment community, then there could be an immediate and significant impact on
the trading price for the Company's Common Stock. Additionally, changes in
earnings estimated by analysts, general conditions in the economy, the financial
markets or the health care, pharmaceutical, biotechnology or CRO industries,
implementation of proposed healthcare reforms or other developments affecting
the Company could cause the market price of the Common Stock to fluctuate
substantially. In recent years the stock market has experienced extreme price
and volume fluctuations. This volatility has had a significant effect on the
market prices of securities issued by many companies for reasons unrelated to
their operating performance.
ITEM 2. PROPERTIES
The Company both owns and leases its facilities. The Company's
headquarters are located in Nashville, Tennessee. Additionally, the Company has
offices in Research Triangle Park, North Carolina; Lexington, Kentucky; Chicago,
Illinois; Maidenhead, U.K.; Glasgow, Scotland; Brussels, Belgium; Melbourne,
Australia; Milan, Italy; Santiago, Chile; Paris, France; and Jerusalem, Israel.
The Company utilizes both owned and leased laboratory and office space in
Senneville, Quebec.
The Company believes that the space leased is adequate for the
Company's operations and that the leases generally reflect market rates in their
respective geographic areas. The expiration dates of the leases range from 1998
to 2013.
In 1997, the Company moved its Nashville operations and corporate
headquarters into a new building. The Company leases approximately 53,000 square
feet of this building.
In 1996, the Company agreed to lease approximately 151,000 square feet
in a building to be constructed in Cary, North Carolina. Upon its completion in
mid-1998, the Company will move its Research Triangle Park operations into the
new building.
ITEM 3. LEGAL PROCEEDINGS
The Company is from time to time subject to claims and suits arising in
the ordinary course of business. In the opinion of management, there are
currently no proceedings to which the Company is a party that will have a
material adverse effect upon its operations or financial condition.
In 1991, a customer commenced legal action against the predecessor of
the Company's preclinical subsidiary claiming damages resulting from statistical
errors in carrying out two clinical research studies. Judgment was rendered in
February 1997 by the Superior Court of Montreal against the Company's subsidiary
in the amount of approximately $560,000 plus interest to accrue from September
1991. The Company's preclinical subsidiary, now responsible for this action, has
reserves adequate to cover the current judgment amount. The Company's
preclinical subsidiary has appealed the amount of the judgment and the
subsidiary's insurance company has appealed the portion of the judgment which
obligates the insurance company to pay the insurance claim related to this
litigation. The Company believes it is entitled, subject to certain limitations,
to indemnification from a former owner of the predecessor for a portion of this
claim. In the opinion of management, the ultimate resolution of such pending
legal proceedings will not have a material effect on the Company's financial
position or results of operations.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
13
15
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
The Company's Common Stock trades on The Nasdaq Stock Market ("Nasdaq")
under the symbol "CCRO". On March 16, 1998, the last reported sale price for the
Common Stock on Nasdaq was $7.56. As of December 31, 1997, the Company had
approximately 229 holders of record of the Common Stock and the Company
estimates an additional 5,450 beneficial owners. The following table shows the
high and low sales prices for the Common Stock as reported by Nasdaq for the
periods indicated, as adjusted for a 3-for-2 stock split on November 25, 1996:
HIGH LOW
---- ---
1996
First Quarter......................................................................... 23.75 13.00
Second Quarter........................................................................ 33.67 22.67
Third Quarter......................................................................... 32.75 20.00
Fourth Quarter........................................................................ 29.17 16.88
1997
First Quarter......................................................................... 32.00 7.75
Second Quarter........................................................................ 12.63 6.50
Third Quarter......................................................................... 12.69 8.25
Fourth Quarter........................................................................ 9.38 6.25
1998
First Quarter (Through March 16).................................................... 8.50 6.25
The Company has paid no dividends since inception.
ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA
Information concerning this Item is incorporated herein by reference to page 5
of the Company's Annual Report to its stockholders for the fiscal year ended
December 31, 1997.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
Information concerning this Item is incorporated herein by reference to pages 6
through 9 of the Company's Annual Report to its stockholders for the fiscal year
ended December 31, 1997.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Information concerning this Item is incorporated herein by reference to pages 10
through 20 of the Company's Annual Report to its stockholders for the fiscal
year ended December 31, 1997.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
14
16
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS
Information concerning this Item is incorporated herein by reference to the
Company's definitive proxy materials for the Company's 1998 Annual Meeting of
stockholders.
ITEM 11. EXECUTIVE COMPENSATION
Information concerning this Item is incorporated herein by reference to the
Company's definitive proxy materials for the Company's 1998 Annual Meeting of
stockholders.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Information concerning this Item is incorporated herein by reference to the
Company's definitive proxy materials for the Company's 1998 Annual Meeting of
stockholders.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
None.
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
(a)(1) Financial Statements of the Company and its subsidiaries required to be
included in Part II, Item 8 are incorporated by reference to the Company's
Annual Report to stockholders for the fiscal year ended December 31, 1997.
(a)(2) and (d) Schedule II -- Valuation and Qualifying Accounts (filed as
Exhibit 99 hereto).
15
17
(a)(3) and (c) Exhibits.
3.1 -- Restated Certificate of Incorporation, as amended, of the Registrant
(incorporated by reference to Exhibit 3.1 to the Company's Annual Report
on Form 10-K for the year ended December 31, 1993)
3.2 -- Restated Bylaws of the Registrant (incorporated by reference to Exhibit
3.2 to the Company's Registration Statement No. 33-69586 on Form S-1)
4.1 -- Restated Certificate of Incorporation, as amended, of the Registrant (see
Exhibit 3.1)
4.2 -- Restated Bylaws of the Registrant (see Exhibit 3.2)
4.3 -- Specimen Common Stock Certificate (incorporated by reference to Exhibit
4.3 to the Company's Annual Report on Form 10-K for the year ended December
31, 1993)
10.1 -- Executive Compensation Plans and Arrangements
(a) Form of Employment Agreement between the Company and certain of its
officers
(b) Employment Agreement between the Company and Michael F. Ankcorn
(incorporated by reference to Exhibit 10.1(b) to the Company's Annual
Report on Form 10-K for the year ended December 31, 1996)
(c) Form of Employment Agreement between the Company and its Executive
Chairman and President and Chief Executive Officer
10.2 -- Form of Indemnification Agreement between the Registrant and each of its
directors (incorporated by reference to Exhibit 10.2 to the Company's
Registration Statement No. 33-69586 on Form S-1)
10.3 -- 1989 Stock Option Plan, as amended (incorporated by reference to Exhibit
10.5 to the Company's Registration Statement No. 33-69586 on Form S-1)
10.4 -- Amendment No. 4 to 1989 Stock Option Plan (incorporated by reference to
Exhibit 10.5 to the Company's Annual Report on Form 10- K for the year
ended December 31, 1994)
10.5 -- Profit Sharing 401(k) Plan (incorporated by reference to Exhibit 10.6 to
the Company's Registration Statement No. 33-69586 on Form S-1)
10.6 -- Lease Agreements for the Registrant's Research Triangle Park, North Carolina
office space (incorporated by reference to Exhibit 10.11 to the Company's
Registration Statement No. 33-69586 on Form S-1)
10.6.1 -- Sublease Agreement dated June 3, 1994 for additional space in Research
Triangle Park, North Carolina (incorporated by reference to Exhibit
10.8.1 to the Company's Annual Report on Form 10-K for the year ended
December 31, 1994)
10.7 -- Lease Agreement for the Registrant's Lexington, Kentucky office space
(incorporated by reference to Exhibit 10.12 to the Company's Registration
Statement No. 33-69586 on Form S-1)
10.8 -- Lease Contract for the Registrant's Brussels, Belgium office space
(incorporated by reference to Exhibit 10.13 to the Company's Registration
Statement No. 33-69586 on Form S-1)
10.9 -- Agreement for Lease for the Registrant's Maidenhead, England office space
(incorporated by reference to Exhibit 10.14 to the Company's Registration
Statement No. 33-69586 on Form S-1)
10.10 -- Second Amended and Restated Loan and Security Agreement dated December
8, 1993 by and between NationsBank of Tennessee, N.A., the Registrant
and its subsidiaries (incorporated by reference to Exhibit 10.11 to the
Company' Annual Report on Form 10-K for the year ended December 31, 1993)
10.11 -- Lease Agreement dated December 19, 1995 for the Company's headquarters space
in Nashville, Tennessee (incorporated by reference to Exhibit 10.12 to the
Company's Annual Report on Form 10-K for the year ended December 31, 1995)
10.12 -- Asset Purchase Agreement among Bio-Research Laboratories Ltd., certain
shareholders thereof, and the Company (incorporated by reference to the
Company's Current Report on Form 8-K filed on June 19, 1996)
10.13 -- Lease dated September 30, 1996 for new offices (commencing in 1998) in
Cary, North Carolina (incorporated by reference to Exhibit 10.14 to the
Company's Annual Report on Form 10-K for the year ended December 31,
1996)
10.14 -- Option Agreement to purchase MPI Research, LLC dated January 30, 1998
between the Company and Jerry R. Mitchell, M.D., Ph.D. and William U.
Parfet
11 -- Statement re: computation of per share earnings
13 -- Pages 5 through 20 of Annual Report to Stockholders for fiscal year
ended December 31, 1997
21 -- List of Subsidiaries of the Registrant
23 -- Consent of Ernst & Young LLP
27.1 -- Financial Data Schedule for the year ended December 31, 1997 (for SEC use only)
27.2 -- Financial Data Schedule Restated for the year ended December 31,
1996 (for SEC use only)
99 -- Schedule II -- Valuation and Qualifying Accounts.
(b) No reports on Form 8-K were filed during the quarter ended December 31,
1997.
16
18
SIGNATURES
Pursuant to the requirements 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.
CLINTRIALS RESEARCH INC.
By: /s/ JERRY R. MITCHELL
--------------------------------
Jerry R. Mitchell, M.D., Ph.D.
President and Chief Executive Officer, Director
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/ JERRY R. MITCHELL
- ------------------------------ President and Chief Executive March 27, 1998
Jerry R. Mitchell, M.D., Ph.D. Officer, Director
/s/ WILLIAM C. O'NEIL, JR.
- ------------------------------ Executive Chairman of the March 27, 1998
William C. O'Neil, Jr. Board
/s/ MARY A. CHAPUT
- ------------------------------ Chief Financial Officer and March 27, 1998
Mary A. Chaput Secretary (Principal
Financial and Accounting
Officer)
/s/ EDWARD G. NELSON
- ------------------------------ Director March 27, 1998
Edward G. Nelson
/s/ THOMAS G. CIGARRAN
- ------------------------------ Director March 27, 1998
Thomas G. Cigarran
/s/ RICHARD J. ESKIND
- ------------------------------ Director March 27, 1998
Richard J. Eskind
/s/ IRWIN B. ESKIND
- ------------------------------ Director March 27, 1998
Irwin B. Eskind, M.D.
/s/ ROSCOE R. ROBINSON
- ------------------------------ Director March 27, 1998
Roscoe R. Robinson, M.D.
17
19
INDEX TO EXHIBITS
EXHIBIT
NUMBER EXHIBITS
------ --------
3.1 -- Restated Certificate of Incorporation, as amended, of the Registrant
(incorporated by reference to Exhibit 3.1 to the Company's Annual
Report on Form 10-K for the year ended December 31, 1993)
3.2 -- Restated Bylaws of the Registrant (incorporated by reference to
Exhibit 3.2 to the Company's Registration Statement No. 33-69586
on Form S-1)
4.1 -- Restated Certificate of Incorporation, as amended, of the Registrant
(see Exhibit 3.1)
4.2 -- Restated Bylaws of the Registrant (see Exhibit 3.2)
4.3 -- Specimen Common Stock Certificate (incorporated by reference to
Exhibit 4.3 to the Company's Annual Report on Form 10-K for the
year ended December 31, 1993)
10.1 -- Executive Compensation Plans and Arrangements
(a) Form of Employment Agreement between the Company and certain of
its officers
(b) Employment Agreement between the Company and Michael F. Ankcorn
(incorporated by reference to Exhibit 10.1(b) to the Company's
Annual Report on Form 10-K for the year ended December 31, 1996)
(c) Form of Employment Agreement between the Company and its Executive
Chairman and President and Chief Executive Officer
10.2 -- Form of Indemnification Agreement between the Registrant and each
of its directors (incorporated by reference to Exhibit 10.2 to the
Company's Registration Statement No. 33-69586 on Form S-1)
10.3 -- 1989 Stock Option Plan, as amended (incorporated by reference to
Exhibit 10.5 to the Company's Registration Statement No. 33-69586
on Form S-1)
10.4 -- Amendment No. 4 to 1989 Stock Option Plan (incorporated by reference
to Exhibit 10.5 to the Company's Annual Report on Form 10- K for
the year ended December 31, 1994)
10.5 -- Profit Sharing 401(k) Plan (incorporated by reference to Exhibit
10.6 to the Company's Registration Statement No. 33-69586 on Form S-1)
10.6 -- Lease Agreements for the Registrant's Research Triangle Park, North
Carolina office space (incorporated by reference to Exhibit 10.11 to
the Company's Registration Statement No. 33-69586 on Form S-1)
10.6.1 -- Sublease Agreement dated June 3, 1994 for additional space in Research
Triangle Park, North Carolina (incorporated by reference to Exhibit
10.8.1 to the Company's Annual Report on Form 10-K for the year ended
December 31, 1994)
10.7 -- Lease Agreement for the Registrant's Lexington, Kentucky office space
(incorporated by reference to Exhibit 10.12 to the Company's Registration
Statement No. 33-69586 on Form S-1)
10.8 -- Lease Contract for the Registrant's Brussels, Belgium office space
(incorporated by reference to Exhibit 10.13 to the Company's Registration
Statement No. 33-69586 on Form S-1)
10.9 -- Agreement for Lease for the Registrant's Maidenhead, England office
space (incorporated by reference to Exhibit 10.14 to the Company's
Registration Statement No. 33-69586 on Form S-1)
10.10 -- Second Amended and Restated Loan and Security Agreement dated December
8, 1993 by and between NationsBank of Tennessee, N.A., the Registrant
and its subsidiaries (incorporated by reference to Exhibit 10.11 to the
Company's Annual Report on Form 10-K for the year ended December 31, 1993)
10.11 -- Lease Agreement dated December 19, 1995 for the Company's headquarters
space in Nashville, Tennessee (incorporated by reference to Exhibit
10.12 to the Company's Annual Report on Form 10-K for the year ended
December 31, 1995)
10.12 -- Asset Purchase Agreement among Bio-Research Laboratories Ltd., certain
shareholders thereof, and the Company (incorporated by reference to
the Company's Current Report on Form 8-K filed on June 19, 1996)
10.13 -- Lease dated September 30, 1996 for new offices (commencing in 1998) in Cary,
North Carolina (incorporated by reference to Exhibit 10.14 to the
Company's Annual Report on Form 10-K for the year ended December 31, 1996)
10.14 -- Option Agreement to purchase MPI Research, LLC dated January 30, 1998
between the Company and Jerry R. Mitchell, M.D., Ph.D. and William U. Parfet
11 -- Statement re: computation of per share earnings
13 -- Pages 5 through 20 of Annual Report to Stockholders for fiscal year
ended December 31, 1997
21 -- List of Subsidiaries of the Registrant
23 -- Consent of Ernst & Young LLP
27.1 -- Financial Data Schedule for the year ended December 31, 1997 (for SEC use only)
27.2 -- Financial Data Schedule Restated for the year ended December 31,
1996 (for SEC use only)
99 -- Schedule II -- Valuation and Qualifying Accounts.