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EXHIBIT 99.01
Risk Factors You Should Consider
Dependence on the Pharmaceutical and Biotechnology Industries
Our revenues depend on the research and development and sales and
marketing expenditures of the pharmaceutical and biotechnology industries.
To date, we have benefited from the tendency of companies in those
industries to hire outside organizations to conduct large clinical
research and sales and marketing projects. If these industries experience
a general market decline or begin to reduce their propensity to outsource
those projects, our operations and financial condition could be materially
and adversely affected.
Management of Growth
We have grown rapidly over the past 10 years. We believe that our
continued growth may place a strain on our existing operational, human and
financial resources. In order to manage our growth, we must continue to
(1) improve our operating and administrative systems, (2) attract and
retain qualified management, professional, scientific and technical
personnel and (3) assimilate differences in foreign business practices and
overcome language barriers.
Under our transnational organizational structure, a holding company
manages the operations of our service groups which perform complementary
functions. To date, this structure has successfully supported our growth.
We recently completed a number of acquisitions, and we cannot assure you
that our operational structure will continue to be effective. Failure to
effectively manage our growth could result in a material adverse effect on
our operations and financial condition.
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Risks Associated with Acquisitions
We have completed numerous acquisitions both within the United States and
internationally over the last several years and in 1998. In addition, we
are currently reviewing many acquisition candidates and continually
evaluating and competing for new acquisition opportunities. Acquisitions
involve numerous risks, including:
-- difficulties and expenses incurred during the acquisition;
-- integration of the acquired companies' operations and
services;
-- diversion of our management's attention from other business
concerns;
-- potential loss of the acquired companies' key employees;
-- the risk that acquired companies will not perform as expected;
-- Year 2000 risks of the acquired companies;
-- additional risks of assimilating differences in foreign
business practices and overcoming language barriers (for
acquisitions of foreign companies);
-- potential losses resulting from undiscovered liabilities of
acquired companies that are not covered by the indemnification
we may obtain from the sellers; and
-- expenses related to acquisition negotiations that are not
completed.
We cannot assure you that we can continue to successfully integrate into
our operations our past acquisitions or those we complete in the future.
Furthermore, we cannot assure you that we will either successfully
complete future acquisitions or that our completed acquisitions will
contribute favorably to our operations and future financial condition. The
realization of any of these risks associated with acquisitions could
result in a material adverse effect on our operations and financial
condition.
Risks Relating to Contract Sales Services
Outsourced contract sales services, or hiring outside organizations to
perform sales and marketing projects, is a relatively new industry in some
countries where we operate. We believe that this industry emerged because
of regulatory agencies' actions to place cost containment pressure on
pharmaceutical companies. As a result, large pharmaceutical companies
began to outsource their sales and marketing activities incident to
product launches (which typically require deployment of large numbers of
sales personnel for a relatively short amount of time). Many countries,
including the United States, have a low level of market penetration for
outsourced sales and marketing services. Thus, all companies in this
industry are subject to the risks inherent in a new or emerging industry,
including:
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-- an inability to attract and retain customers;
-- changes in the regulatory regime;
-- an absence of an established earnings history;
-- the availability of properly trained personnel; and
-- any unforeseen costs and expenses.
Competition
Since we offer an extensive range of services, we face a broad range of
competitors. Some of our competitors compete against us only with respect
to a single service or group of services, while others may compete across
a broader portion of our service lines. Our competitors generally fall
within the following categories:
Contract Research: traditional contract research organizations; the
in-house research and development departments of pharmaceutical
companies; universities; and teaching hospitals; consulting firms,
including boutique firms specializing in the healthcare industry and
the healthcare departments of large consulting firms.
Contract Sales: in-house sales and marketing departments of
pharmaceutical companies; contract sales organizations in countries
where we operate; and consulting firms offering medical
communications services.
Factors that affect our ability to compete include:
-- the highly competitive nature of the market for contract
research services;
-- our competitors' expansion into other areas in which we
operate;
-- increases in competition, which may lead to price and other
forms of competition that could have an effect on our profit
margins;
-- consolidation within the pharmaceutical industry, compounded
by a trend among pharmaceutical companies to limit outsourcing
to fewer full-service global organizations; and
-- the trend towards consolidation among the providers of
contract research and contract sales services, which could
result in greater competition among the larger contract
research and contract sales providers for customers and
acquisition candidates.
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Loss or Delay of Large Contracts
Most of our customers can terminate our contracts upon 15-90 days' notice.
In the event of termination, our contracts often provide for fees for
winding down the project. Still, the loss or delay of a large contract or
the loss or delay of multiple contracts could adversely affect our future
net revenue and profitability.
Variability of Backlog
We report backlog based on anticipated net revenue from uncompleted
projects that a customer has authorized. A number of factors may affect
our backlog, including:
-- the variable size and duration of projects (some are performed
over several years);
-- the loss or delay of projects; and
-- a change in the scope of work during the course of a project.
We cannot assure you that the backlog we have reported will be indicative
of our future results.
Risks of Cost Overruns on Fixed Price Contracts
Most of our service contracts have either a fixed price, a fixed price
with variable components or a fee-for-service subject to a cap. Under this
structure, we bear the risk of cost overruns. Underpricing of contracts or
significant cost overruns could have a material adverse effect on us.
Impact of the Year 2000 Issue
The Year 2000 issue results from computer processors and software failing
to process date values correctly, potentially causing system failures or
data corruption. The Year 2000 issue could cause disruptions of our
operations, including, among other things, a temporary inability to
process information; receive information, services or products from third
parties; interface with customers in the performance of contracts; or
operate or communicate in some or all of the regions in which we do
business.
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We face both internal and external risks from the Year 2000 issue. If
realized, these risks could have a material adverse effect on our
business, results of operations or financial condition. Our primary
internal risk is that our systems will not be Year 2000 compliant on time.
The magnitude of this risk depends on our ability to achieve compliance of
both internally and externally developed systems or to migrate to
alternate systems in a timely fashion. The decentralized nature of our
business may compound this risk if we are unable to coordinate efforts
across our global operations on a timely basis. We have established a Year
2000 Program that management believes will successfully address these
risks, however, we cannot guarantee that this program will be completed in
a timely manner. For a more complete discussion of our Year 2000 Program
and progress to date, you should refer to the explanation of it in
Management's Discussion and Analysis of Financial Condition and Results of
Operations included in our most recent Form 10-Q
Notwithstanding our Year 2000 Program, we also face external risks that
may be beyond our control. Our international operations and our
relationships with foreign third parties create additional risks for us,
as many countries outside the United States have been less attuned to the
Year 2000 issue. These risks include the possibility that infrastructural
systems, such as electricity, water, natural gas or telephony, will fail
in some or all of the regions in which we operate, as well as the danger
that the internal systems of our foreign suppliers, service providers and
customers will fail. Our business also requires considerable travel, and
our ability to perform services under our customer contracts could be
negatively affected if air travel is disrupted by the Year 2000 issue.
In addition, our business depends heavily on the healthcare industry,
particularly on third party physician investigators. The healthcare
industry, and physicians' groups in particular, to date may not have
focused on the Year 2000 issue to the same degree as some other
industries, especially outside of major metropolitan centers. As a result,
we face increased risk that our physician investigators will be unable to
provide us with the data that we need to perform under our contracts on
time, if at all. Thus, the clinical study involved could be slowed or
brought to a halt. Also, the failure of our customers to address the Year
2000 issue could negatively impact their ability to utilize our services.
While we intend to develop contingency plans to address certain of these
risks, we cannot assure you that any developed plans will sufficiently
insulate us from the effects of these risks. Any disruptions resulting
from the realization of these risks would affect our ability to perform
our services. If we are unable to receive or process information, or if
third parties are unable to provide information or services to us, we may
not be able to meet milestones or obligations under our customer
contracts, which could have a material adverse effect on our business and
financial results.
Our estimates regarding the cost, timing and impact of addressing the Year
2000 issue are based on numerous assumptions of future events, including
the continued availability of certain resources, our ability to meet our
deadlines and the cooperation of third parties. We cannot guarantee that
our assumptions will be correct and that these estimates will be achieved.
Actual results could differ materially from our expectations as a result
of numerous factors, including the availability and cost of personnel
trained in this area, the ability to locate and correct all relevant
computer codes, unforeseen circumstances that would cause us to allocate
our resources elsewhere and similar uncertainties.
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Dependence on Key Executives and Personnel
We rely on a number of key executives, including Dennis B. Gillings,
Ph.D., our Chairman of the Board of Directors and Chief Executive Officer.
We maintain key man life insurance on Dr. Gillings in the amount of $3
million. The departure of any key executive could have a material adverse
effect on our operations or financial condition. In addition, our
performance depends on our ability to attract and retain qualified
management and professional, scientific and technical operating staff, as
well as our ability to recruit qualified representatives for our contract
sales services. We cannot assure you that we will be able to continue to
attract and retain qualified personnel.
Potential Liabilities
Potential Liabilities Arising From Contract Research Services
We contract with physicians to serve as investigators in conducting
clinical trials to test new drugs on human volunteers. Such testing
creates risk of liability for personal injury to or death of volunteers,
particularly to volunteers with life-threatening illnesses, resulting from
adverse reactions to the drugs administered during testing. It is possible
third parties could claim that we should be held liable for losses arising
from any professional malpractice of the investigators with whom we
contract or in the event of personal injury to or death of persons
participating in clinical trials. We do not believe we are legally
accountable for the medical care rendered by third party investigators,
and we would vigorously defend any such claims. Nonetheless, it is
possible we could be found liable for those types of losses.
Since we have Phase I clinical trial facilities, we also could be liable
for the general risks associated with a Phase I facility. These risks
include, but are not limited to, adverse events resulting from the
administration of drugs to clinical trial participants or the professional
malpractice of Phase I medical care providers.
Potential Liabilities Arising From Other Services
We also could be held liable for errors or omissions in connection with
the services each of our service groups perform.
Measures to Reduce Risk From Potential Liabilities.
We attempt to reduce risk from potential liabilities through:
-- contractual indemnification provisions with customers and
investigators;
-- insurance maintained by us, our customers and our
investigators;
-- various regulatory requirements, including the use of
institutional review boards; and
-- the procurement of each volunteer's informed consent to
participate in a study.
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You should note several aspects about our contractual indemnifications.
First, they generally do not fully protect us against some of our own
actions, such as negligence. Second, the terms and scope of each
indemnification vary from customer to customer and from trial to trial.
Finally, the financial performance of any of these indemnities is not
secured. As a result, we bear the risk that the indemnifying party may not
have the financial ability to fulfill its indemnification obligations.
Our professional liability insurance covers the worldwide territories in
which we operate and includes drug safety issues, as well as data
processing errors and omissions. We can offer you no assurance that we
will be able to maintain this insurance on terms acceptable to us or that
this insurance will cover all of our losses. We caution you that our
financial condition could be materially and adversely affected if we were
required to pay damages or bear the costs of defending any claim (1)
outside the scope of or in excess of a contractual indemnification
provision, (2) beyond the level of insurance coverage or (3) in the event
that an indemnifying party does not fulfill its indemnification
obligations.
Effect of Government Regulation
Our contract research business benefits from the extensive governmental
regulation of the drug development/approval process, particularly in the
United States. From time to time legislation is introduced in the U.S.
Congress to substantially modify regulations administered by the Food and
Drug Administration, the agency governing this process. We believe the
level of regulation is generally less burdensome outside the United
States. Still, European countries are attempting to establish common
standards for clinical testing of new drugs. This trend has caused changes
in the various requirements currently imposed by each country. Some of the
changes under consideration in the United States and elsewhere include
mandatory substitution of generic drugs for patented drugs, relaxation in
the scope of regulatory requirements or the introduction of simplified
drug approval procedures. These and other changes in regulation could
decrease the business opportunities available to us. In addition, any
failure on our part to comply with applicable regulations could result in
the termination of ongoing clinical research or sales and marketing
projects or the disqualification of data for submission to regulatory
authorities, either of which could have a material adverse effect on us.
Uncertainty in Healthcare Industry and Possible Healthcare Reform
Changing political, economic and regulatory influences in the healthcare
industry may affect the pharmaceutical, biotechnology and medical device
industries. Numerous governments have undertaken efforts to control
growing healthcare costs through legislation, regulation and voluntary
agreements with medical care providers and pharmaceutical companies.
Implementation of government healthcare reform may adversely affect
research and development expenditures by these companies, which could
decrease the business opportunities available to us. We cannot predict the
likelihood of healthcare reform legislation being enacted or the effects
such legislation would have on our operations.
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Exchange Rate Fluctuation Risks
We derive a large portion of our net revenue from our operations outside
the United States, as illustrated by the following table:
% of Net Revenue from
Year Foreign Operations
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1997 50.0%
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1996 57.0%
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1995 60.1%
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Factors associated with international operations, including changes in
foreign currency exchange rates and uncertainties relative to regional
economic circumstances, could significantly affect our operations and
financial results. Exchange rate fluctuations between local currencies and
the U.S. dollar create risk in several ways, including:
-- Foreign Currency Translation Risk. The revenue and expenses of
our foreign operations are generally denominated in local
currencies.
-- Foreign Currency Transaction Risk. Our service contracts may
be denominated in a currency other than the currency in which
we incur expenses related to such contracts.
We try to limit these risks through exchange rate fluctuation provisions
stated in our service contracts, or we may hedge our transaction risk with
foreign currency exchange contracts or options. Despite these efforts, we
may still experience fluctuations in financial results from our operations
outside the United States, and we cannot assure you that we will be able
to favorably reduce our currency transaction risk associated with our
service contracts.
Variation in Our Quarterly Results
The results of our operations have been, and can be expected to be,
subject to quarterly fluctuations. Quarterly results can fluctuate as a
result of a number of factors, including:
-- the timing of start-up expenses for new offices;
-- the completion of acquisitions;
-- the completion or commencement of significant contracts;
-- changes in the mix of services offered; and
-- foreign exchange fluctuations.
Because of these factors, we believe that you should not rely on quarterly
comparisons of our financial results as an indication of our future
performance.
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Volatility of Our Stock Price
The market price of our common stock has been and may continue to be
subject to wide fluctuations. Factors affecting our stock price may
include (1) variations in operating results from quarter to quarter, (2)
changes in earnings estimates by analysts, (3) market conditions in the
industry and (4) general economic conditions.
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