Filed On 6/15/05 9:49pm ET · SEC File 333-124981 · Accession Number 950133-5-2686
As Of Filer Filing As/For/On Docs:Pgs Issuer Agent
6/16/05 PRA International 424B4 1:158 950133
Document/Exhibit Description Pages Size
1: 424B4 Pra International 424B4 HTML 1,081K
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Filed Pursuant to Rule 424(b)(4)
7,200,000 Shares
Common Stock
The selling stockholders named in this prospectus are selling
7,200,000 shares of common stock. We will not receive any
of the proceeds from the shares of common stock sold by the
selling stockholders.
Our common stock is listed on The Nasdaq National Market under
the symbol
“PRAI.” On
June 14, 2005, the last
reported sale price of our common stock was $23.75 per
share.
The underwriters have an option to purchase a maximum of
1,080,000 additional shares from the selling stockholders
to cover over-allotments of shares.
Investing in our common stock involves risks. See “Risk
Factors” beginning on page 9.
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Underwriting |
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Proceeds to |
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Price to |
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Discounts and |
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the Selling |
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Public |
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Commissions |
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Stockholders |
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Per Share
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$23.50 |
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$1.12 |
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$22.38 |
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Total
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$169,200,000 |
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$8,037,000 |
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$161,163,000 |
Delivery of the shares of common stock will be made on or about
June 20, 2005.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
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| Credit Suisse First Boston |
Bear, Stearns & Co. Inc. |
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| William Blair & Company |
Jefferies & Company, Inc. |
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F-1 |
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You should rely only on the information contained in this
prospectus or to which we have referred you. We have not
authorized anyone to provide you with information that is
different. This prospectus may only be used where it is legal to
sell these securities. The information in this prospectus may
only be accurate on the date of this prospectus.
PROSPECTUS SUMMARY
This summary may not contain all of the information that may
be important to you. You should read the entire prospectus,
including the financial statements and related notes, before
making an investment decision. For convenience in this
prospectus, “PRA International,” “PRA,”
“we,” “us,” and “our” refer to PRA
International and its subsidiaries, taken as a whole.
PRA International
We are a leading global
contract research organization, or CRO,
with approximately 2,500 employees working from 24 offices
located in North America, Europe, Africa, South America,
Australia, and Asia. CROs assist pharmaceutical and
biotechnology companies in developing and taking drug compounds,
biologics, and drug delivery devices through appropriate
regulatory approval processes. The conduct of clinical trials,
in which a product candidate is tested for safety and efficacy,
forms a major part of the regulatory approval process.
Completing the approval process as efficiently and quickly as
possible is a priority for sponsoring pharmaceutical and
biotechnology companies because they must receive regulatory
approval prior to marketing their products anywhere in the
world. Revenue for CROs is typically generated on a fee for
service basis on either a time and materials or a fixed-price
contract arrangement with the client organization.
We conduct clinical trials globally and are one of a few CROs in
the world with the capability to serve the growing need of
pharmaceutical and biotechnology companies to conduct complex
clinical trials in multiple geographies concurrently. We
incorporated in Delaware in April 2001, with predecessors dating
back to 1976. Our qualified and experienced clinical and
scientific staff has been delivering clinical drug development
services to our customers for over 25 years, and our
service offerings now encompass all points of the clinical drug
development process. We provide our expertise in several
therapeutic areas of strategic interest to our customers,
including oncology, central nervous system, or CNS,
cardiovascular, and respiratory/allergy product development.
We perform a broad array of services across the spectrum of
clinical development programs, from the filing of
Investigational New Drug applications, or INDs, and similar
foreign regulatory applications, to the conduct of all phases of
clinical trials, to drug registration and post-marketing
studies. Our core global clinical development services include
the following:
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creating drug development and regulatory strategy plans; |
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executing Phase I clinical trials; |
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performing Phase II through IV multi-center,
international clinical trials; |
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developing and analyzing integrated global clinical databases; |
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preparing and submitting regulatory filings around the
world; and |
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managing long-term drug safety programs. |
Since 1999, we have conducted over 2,300 clinical trial programs
for over 295 clients. We have collaborated with nine of the ten
largest pharmaceutical companies and seven of the ten largest
biotechnology companies over the last two years in all major
therapeutic areas. In 2004, we generated service revenue of
$277.5 million, of which approximately 52% was derived from
biotechnology companies, 38% from large pharmaceutical
companies, and 10% from Japanese pharmaceutical companies.
Our Industry
Companies in the pharmaceutical and biotechnology industries
outsource clinical product development services to CROs in order
to manage the drug development process more efficiently and
cost-effectively and to speed time to market. PRA and other CROs
provide clinical drug development services, including protocol
design and management of Phase I through IV clinical
trials, data management, laboratory
1
testing, and statistical analysis. Some other CROs also provide
preclinical services. CROs provide services that generate
high-quality and timely data in support of applications for
regulatory approval of new drugs or reformulations of existing
drugs as well as to support new and existing marketing claims.
CROs derive substantially all of their revenue from
pharmaceutical and biotechnology companies’ research and
development expenditures, which have increased substantially in
recent years. Specifically, Frost and Sullivan estimates that
research and development expenditures by such companies totaled
$58.5 billion in 2003, an increase from $41.1 billion
in 2000, representing a compounded annual growth rate of 12.5%.
Excluding spending related to administrative functions to
support the research and development process, which are not
typically outsourced to CROs, estimated research and development
expenditures totaled $47.2 billion in 2003, up from
$32.6 billion in 2000, representing a 13.2% compounded
annual growth rate. Of this amount, approximately
$27.4 billion in 2003 was directly related to Phase I
through Phase IV clinical trials. Such spending, which
excludes expenditures related to pre-clinical activities,
increased between 2000 and 2003 at a compounded annual growth
rate of 12.5%, and represents the total amount of research and
development spending that could potentially be outsourced to PRA
or its competitors offering similar services. According to Frost
and Sullivan, in 2003 pharmaceutical and biotechnology companies
outsourced to CROs approximately $8.4 billion, or 30.7% of
their total research and development spending devoted to
Phase I through Phase IV clinical trials, and
outsourcing of such spending is expected to increase to
$18.5 billion by 2010, representing a compounded annual
growth rate of 12.1%.
We believe that a number of factors have contributed, and will
continue to contribute, to the growth of the CRO industry,
including the globalization of drug development, the increased
number of product candidates entering clinical development, the
growth of the biotechnology industry, increased regulatory
scrutiny, and the growing need for quick, efficient, and
cost-effective drug development.
Our Strategy
We intend to continue building PRA into the best clinical
development organization in the world by:
Continuing to Leverage and Build Our Expertise in Key
Therapeutic Areas. We believe that our extensive therapeutic
expertise is critical to our customers and for the proper design
and management of all clinical phases of drug development. We
intend to continue capitalizing on our market positions in our
existing therapeutic categories. We have established a
therapeutic business development initiative that is focused on
identifying early clinical drug candidates in our core
therapeutic competencies. We believe that oncology, CNS,
cardiovascular, and respiratory/allergy, which according to a
report in R&D Directions (October 2003) together
represented approximately 58% of all drug candidates being
developed by pharmaceutical and biotechnology companies, will be
significant drivers of our growth. Furthermore, we plan to
continue to expand our depth of therapeutic expertise in other
attractive therapeutic areas.
Expanding the Breadth and Depth of Our Service Offering.
We plan to build upon our existing expertise in Phase II
and III clinical trials and to enhance our existing service
offerings in Phase I and IV clinical trials, which are
among the fastest growing segments of the CRO industry,
according to Frost and Sullivan. In addition, we intend to
expand our regulatory and drug safety capabilities around the
globe to further serve our clients.
Leveraging Our Infrastructure to Improve Operational
Efficiencies. We have made significant investments and
corporate acquisitions over the past eight years to enhance our
global infrastructure and product offerings. Past investments
include recruiting and training qualified professionals,
developing a worldwide network of offices, and building an
integrated information technology platform. We believe that
these investments will enable us to improve patient recruitment,
improve efficiency of global clinical trial data collection, and
speed regulatory submissions for customers, resulting in
improved project margins and overall profits. We plan to
continue to enhance our information technology platform to
maintain our competitiveness and our adaptable and flexible
business support environment. We continue to make additional
investments and staff training commitments in our proprietary
quality management system, called PRA Management System, or
PRAMS, and have obtained International Standards Organization
2
9001:2000 registration certification. We believe
ISO 9001:2000 certification will assist us in obtaining
more global projects and measuring output and customer
satisfaction. PRAMS reinforces Project
Assurance
sm,
our company-wide commitment to consistently achieving customer
requirements every time, at every location.
Augmenting Our Geographic Reach in Latin America and
Asia. We intend to replicate the success we have achieved in
North America, Europe, and existing Southern Hemisphere
locations to further expand in Latin America and in Asia, both
of which have large population bases and developing clinical
scientific infrastructures.
Continuing to Pursue a Disciplined Acquisition Strategy.
We have demonstrated skill in identifying, purchasing, and
integrating high-quality strategic acquisitions. We have
developed a well-refined integration process to ensure a
consistent and streamlined assimilation of the staff and
expertise of the acquired company. We expect to
opportunistically pursue acquisitions that broaden our product
development platform, geographic reach, and therapeutic
capabilities.
Our Competitive Strengths
Global Leadership Position. We have significant global
reach with resources and knowledge that enable us to seamlessly
conduct trials on six continents concurrently. Our global scale
enables us to select locations that produce more efficient and
cost-effective clinical drug development.
Therapeutic Expertise and Scientific Depth. Our breadth
of experience allows us to offer drug development services,
vendor management, and patient recruitment access across a broad
spectrum of therapeutic indications. We believe that we are a
world leader in oncology, CNS, cardiovascular, and
respiratory/allergy drug development, which are all therapeutic
areas requiring significant scientific expertise and which
collectively accounted for 72.8% of all global research and
development spending by pharmaceutical and biotechnology
companies in 2003, according to Frost and Sullivan.
Attractive Customer Base. We have collaborated with nine
of the ten largest pharmaceutical companies and seven of the ten
largest biotechnology companies over the last two years in all
major therapeutic areas and have a particular strength in
serving the expanding biotechnology industry. We currently
provide services to an active customer base of over 220 clients,
and have established preferred vendor relationships with seven
of the world’s leading pharmaceutical and biotechnology
companies.
Proven and Incentivized Management Team and Workforce. We
are led by our experienced executive management team, which has
an average tenure of over 11 years with us or our acquired
companies. This team has been responsible for building our
global platform, maintaining strong client relationships, and
for our significant growth in revenue and earnings. We believe
our employees are well-regarded in the drug development industry
for their scientific expertise and their experience in managing
many complex drug studies.
Strategic Challenges
In the execution of our business strategy, we have faced and
will continue to face the following challenges:
Reduction in Outsourcing. The CRO industry depends upon
companies in the pharmaceutical and biotechnology industries
outsourcing clinical development projects. Consequently, if
pharmaceutical and biotechnology companies experience a general
industry downturn, reduce their research and development
spending, or expand their in-house development capabilities, our
business may be adversely affected.
Potential for Contract Termination. Most of the
contracts
we sign allow for termination without cause upon 30 to
60 days’ notice. The loss or delay of a large
contract
or multiple smaller
contracts could adversely affect our
business by causing decreased staff utilization.
Variations in Quarterly Operating Results. Our quarterly
results vary because of factors such as the commencement,
completion, or cancellation of significant
contracts, the timing
of acquisitions, the mix of
3
contracted services, the fluctuation of foreign exchange rates,
the timing of start-up expenses for new offices and services,
and the costs associated with integrating acquisitions.
Possible Regulatory Reform. Regulatory entities in both
the United States and foreign jurisdictions have instituted
stringent regulatory and statutory controls over the development
and approval of drug and biological products, resulting in
larger and more complex clinical studies. We believe that these
trends have created an increased demand for CRO services.
However, if the scope of regulatory requirements narrows, such
as the introduction of simplified marketing applications for
pharmaceuticals and biological products, our business could be
adversely affected.
Customer Concentration. A significant portion of our
service revenue is derived from a limited number of clients. In
2004, approximately 43% of our service revenue was derived from
our top five clients. We have preferred vendor relationships
with three of these five clients, resulting in a concentration
of service revenue generated from these relationships. Although
the service revenue from each of these clients results from
numerous
contracts spread over many divisions of the client, and
typically across multiple jurisdictions, the loss of, or a
significant decrease in business from, one or more of these
clients could adversely affect our business.
We incorporated in Delaware in April 2001, with predecessors
dating back to 1976, and our principal executive offices are
located at 12120 Sunset Hills Road, Suite 600,
Reston,
Virginia 20190. Our telephone number is (
703) 464-6300, and
our
website address is
http://www.prainternational.com.
Information contained on our
website is not a prospectus and
does not constitute part of this prospectus.
4
The Offering
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Common stock offered by the selling stockholders |
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7,200,000 shares |
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Common stock to be outstanding after this offering |
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22,432,891 shares |
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Use of proceeds |
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We will not receive any proceeds from the sale of shares of our
common stock by the selling stockholders in this offering. |
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Nasdaq National Market symbol |
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“PRAI” |
Unless we indicate otherwise or unless the context otherwise
requires, all information in this prospectus assumes no exercise
of the underwriters’ over-allotment option.
In addition, unless we indicate otherwise or unless the context
otherwise requires, all information in this prospectus excludes:
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3,553,049 shares of our common stock that may be issued
upon the exercise of options outstanding as of May 15,
2005; and |
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1,865,004 shares of our common stock that are reserved for
issuance under our stock option and incentive plans. |
Risk Factors
You should carefully read and consider the information set forth
in “Risk Factors” and all other information set forth
in this prospectus before investing in our common stock.
5
Summary Consolidated Financial Data
The following table sets forth our summary consolidated
financial data as of the dates and for the periods indicated. We
derived the summary consolidated financial data for the three
years ended
December 31, 2002,
2003, and
2004 and balance
sheet data at
December 31, 2003 and
2004 from our audited
consolidated financial statements and related notes included
elsewhere in this prospectus. We have derived the summary
consolidated financial data as of
March 31, 2005 and for
the three months ended
March 31, 2004 and
2005 from our
unaudited interim consolidated financial statements and related
notes included elsewhere in this prospectus. In our opinion, the
unaudited interim consolidated financial statements have been
prepared on the same basis as our audited consolidated financial
statements and include all adjustments, consisting of only
normal, recurring adjustments, necessary for a fair statement of
the results for the unaudited interim periods. The results for
any interim period are not necessarily indicative of the results
that may be expected for a full fiscal year. The summary
consolidated financial data set forth below are not necessarily
indicative of future operating results. You should read the
information set forth below in conjunction with
“Selected
Consolidated Financial Data,” “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations,” and our consolidated financial statements and
their related notes included elsewhere in this prospectus.
On
January 23, 2004, we closed our $25.0 million
tender offer and special dividend/employee option bonus
transaction. We repurchased $0.1 million of shares and
$3.7 million of our outstanding vested stock options, paid
a $16.9 million special dividend to our stockholders, and
paid a $2.7 million special bonus to employee option
holders. The remainder of the $25.0 million was used to pay
fees associated with the transaction. The funds for the
transaction were provided by the
December 23, 2003
refinancing of our credit facilities. During 2004 we expensed
the $3.7 million attributed to the repurchase of vested
stock options and $2.7 million attributed to the special
bonus to employee holders of vested stock options.
On
November 17, 2004, we commenced our initial public
offering and on
November 18, 2004 our common stock began
trading on The Nasdaq National Market under the symbol
“PRAI.” We received from the offering net proceeds of
approximately $67.0 million, of which we used
$28.7 million to extinguish all outstanding principal and
accrued interest under our then existing credit facilities. The
remaining net proceeds of approximately $38.3 million were
raised for the execution of our strategy.
6
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Year Ended | |
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Three Months Ended | |
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December 31, | |
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March 31, | |
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2002 | |
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2003 | |
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2004 | |
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2004 | |
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2005 | |
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(unaudited) | |
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(unaudited) | |
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(dollars in thousands, except per share amounts) | |
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Consolidated Statements of Operations Data:
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Revenue:
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Service revenue
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$ |
176,365 |
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$ |
247,888 |
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$ |
277,479 |
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$ |
66,830 |
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$ |
73,592 |
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Reimbursement revenue
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24,648 |
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42,109 |
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30,165 |
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6,965 |
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7,859 |
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Total revenue
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201,013 |
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289,997 |
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307,644 |
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73,795 |
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81,451 |
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Operating expenses:
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Direct costs
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94,761 |
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126,501 |
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134,067 |
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32,771 |
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35,277 |
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Reimbursable out-of-pocket costs
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24,648 |
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42,109 |
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30,165 |
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6,965 |
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7,859 |
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Selling, general, and administrative
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57,897 |
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80,585 |
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90,139 |
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21,993 |
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24,380 |
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Depreciation and amortization
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6,956 |
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8,967 |
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9,691 |
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2,337 |
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2,776 |
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Management fee
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800 |
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800 |
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704 |
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200 |
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— |
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Option repurchase
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— |
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— |
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3,713 |
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3,713 |
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— |
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Vested option bonus
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— |
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— |
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2,738 |
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1,551 |
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— |
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Income from operations
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15,951 |
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31,035 |
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36,427 |
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4,265 |
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11,159 |
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Interest income (expense), net
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(4,100 |
) |
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(6,856 |
) |
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(3,643 |
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(775 |
) |
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89 |
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Other income (expenses), net
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(721 |
) |
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(4,023 |
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(38 |
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452 |
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(26 |
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Income before income taxes
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11,130 |
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20,156 |
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32,746 |
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3,942 |
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11,222 |
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Provision for income taxes
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5,493 |
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6,909 |
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11,997 |
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1,585 |
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|
4,264 |
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Net income
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$ |
5,637 |
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$ |
13,247 |
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$ |
20,749 |
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$ |
2,357 |
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$ |
6,958 |
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Net income per share:
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Basic
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$ |
0.37 |
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$ |
0.83 |
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$ |
1.13 |
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$ |
0.13 |
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$ |
0.31 |
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Diluted
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$ |
0.32 |
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$ |
0.71 |
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$ |
1.02 |
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$ |
0.12 |
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$ |
0.28 |
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Other Financial Data:
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Net cash provided by (used in) operating activities
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$ |
28,442 |
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$ |
2,058 |
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$ |
71,636 |
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$ |
1,988 |
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$ |
(19,492 |
) |
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Net cash provided by (used in) investing activities
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(24,625 |
) |
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|
(9,599 |
) |
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(32,350 |
) |
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|
(1,532 |
) |
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|
22,485 |
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|
Net cash provided by (used in) financing activities
|
|
|
(14,581 |
) |
|
|
26,028 |
|
|
|
(6,430 |
) |
|
|
(18,087 |
) |
|
|
48 |
|
|
Non-GAAP Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted EBITDA(1)
|
|
$ |
22,186 |
|
|
$ |
35,979 |
|
|
$ |
52,531 |
|
|
$ |
12,318 |
|
|
$ |
13,909 |
|
|
Adjusted EBITDA as a % of service revenue
|
|
|
12.6 |
% |
|
|
14.5 |
% |
|
|
18.9 |
% |
|
|
18.4 |
% |
|
|
18.9 |
% |
|
EBITDA(1)
|
|
$ |
22,186 |
|
|
$ |
35,979 |
|
|
$ |
46,080 |
|
|
$ |
7,054 |
|
|
$ |
13,909 |
|
|
EBITDA as a % of service revenue
|
|
|
12.6 |
% |
|
|
14.5 |
% |
|
|
16.6 |
% |
|
|
10.6 |
% |
|
|
18.9 |
% |
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
As of December 31, | |
|
As of March 31, | |
| |
|
| |
|
| |
| |
|
2003 | |
|
2004 | |
|
2005 | |
| |
|
| |
|
| |
|
| |
| |
|
|
|
|
|
(unaudited) | |
| |
|
(dollars in thousands) | |
|
Consolidated Balance Sheet Data (end of period):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
32,328 |
|
|
$ |
65,888 |
|
|
$ |
68,996 |
|
|
Marketable securities
|
|
|
— |
|
|
|
24,500 |
|
|
|
— |
|
|
Working capital
|
|
|
(8,449 |
) |
|
|
11,478 |
|
|
|
19,542 |
|
|
Total assets
|
|
|
298,558 |
|
|
|
337,344 |
|
|
|
314,151 |
|
|
Long-term debt and capital leases, less current maturities
|
|
|
57,810 |
|
|
|
75 |
|
|
|
36 |
|
|
Stockholders’ equity
|
|
|
74,565 |
|
|
|
150,379 |
|
|
|
157,696 |
|
|
|
| (1) |
Adjusted EBITDA and EBITDA are not substitutes for operating
income, net income, or cash flow from operating activities as
determined in accordance with generally accepted accounting
principles in the United States, or GAAP, as measures of
performance or liquidity. See “Non-GAAP Financial
Measures.” For each of the periods indicated, the following
table sets forth a reconciliation of EBITDA and Adjusted EBITDA
to net income and to net cash provided by (used in) operating
activities. |
7
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Year Ended | |
|
Three Months Ended | |
| |
|
December 31, | |
|
March 31, | |
| |
|
| |
|
| |
| |
|
2002 | |
|
2003 | |
|
2004 | |
|
2004 | |
|
2005 | |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
| |
|
|
|
|
|
|
|
(unaudited) | |
|
(unaudited) | |
| |
|
(dollars in thousands) | |
|
Adjusted EBITDA
|
|
$ |
22,186 |
|
|
$ |
35,979 |
|
|
$ |
52,531 |
|
|
$ |
12,318 |
|
|
$ |
13,909 |
|
| |
Option repurchase
|
|
|
— |
|
|
|
— |
|
|
|
(3,713 |
) |
|
|
(3,713 |
) |
|
|
— |
|
| |
Vested option bonus
|
|
|
— |
|
|
|
— |
|
|
|
(2,738 |
) |
|
|
(1,551 |
) |
|
|
— |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EBITDA
|
|
|
22,186 |
|
|
|
35,979 |
|
|
|
46,080 |
|
|
|
7,054 |
|
|
|
13,909 |
|
| |
Depreciation and amortization
|
|
|
(6,956 |
) |
|
|
(8,967 |
) |
|
|
(9,691 |
) |
|
|
(2,337 |
) |
|
|
(2,776 |
) |
| |
Interest income (expense), net
|
|
|
(4,100 |
) |
|
|
(6,856 |
) |
|
|
(3,643 |
) |
|
|
(775 |
) |
|
|
89 |
|
| |
Provision for income taxes
|
|
|
(5,493 |
) |
|
|
(6,909 |
) |
|
|
(11,997 |
) |
|
|
(1,585 |
) |
|
|
(4,264 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
5,637 |
|
|
|
13,247 |
|
|
|
20,749 |
|
|
|
2,357 |
|
|
|
6,958 |
|
| |
Depreciation and amortization
|
|
|
6,956 |
|
|
|
8,967 |
|
|
|
9,691 |
|
|
|
2,337 |
|
|
|
2,776 |
|
| |
Provision for doubtful receivables
|
|
|
1,888 |
|
|
|
4,851 |
|
|
|
1,914 |
|
|
|
509 |
|
|
|
87 |
|
| |
Amortization of debt discount
|
|
|
379 |
|
|
|
1,642 |
|
|
|
— |
|
|
|
58 |
|
|
|
— |
|
| |
Provision for deferred income taxes
|
|
|
(1,228 |
) |
|
|
(3,997 |
) |
|
|
2,606 |
|
|
|
3 |
|
|
|
(580 |
) |
| |
Debt issuance costs write-off
|
|
|
— |
|
|
|
750 |
|
|
|
1,241 |
|
|
|
— |
|
|
|
— |
|
| |
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Accounts receivable and unbilled services
|
|
|
(29,251 |
) |
|
|
(18,538 |
) |
|
|
15,373 |
|
|
|
240 |
|
|
|
2,057 |
|
| |
|
Prepaid expenses and other assets
|
|
|
1,444 |
|
|
|
408 |
|
|
|
1,226 |
|
|
|
(2,570 |
) |
|
|
(2,400 |
) |
| |
|
Accounts payable and accrued expenses
|
|
|
3,481 |
|
|
|
(4,873 |
) |
|
|
7,793 |
|
|
|
(4,810 |
) |
|
|
(7,846 |
) |
| |
|
Income taxes
|
|
|
989 |
|
|
|
(481 |
) |
|
|
12,150 |
|
|
|
1,393 |
|
|
|
(2,525 |
) |
| |
|
Advance billings
|
|
|
38,147 |
|
|
|
82 |
|
|
|
(1,107 |
) |
|
|
2,471 |
|
|
|
(18,019 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities
|
|
$ |
28,442 |
|
|
$ |
2,058 |
|
|
$ |
71,636 |
|
|
$ |
1,988 |
|
|
$ |
(19,492 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
RISK FACTORS
Any investment in our common stock involves a high degree of
risk. You should carefully consider the following risk factors
and all other information contained in this prospectus,
including our financial statements and the related notes, before
investing in our common stock. If any of the following risks
materialize, our business, financial condition, or results of
operations could be materially harmed. In that case, the market
price of our common stock could decline, and you may lose all or
part of your investment.
Risks Related to Our Business
Our contracts are generally terminable on little or no
notice. Termination of a large contract for services or multiple
contracts for services could adversely affect our revenue and
profitability.
Most of our
contracts are terminable without cause upon 30 to
60 days’ notice by the client. Clients terminate or
delay
contracts for various reasons. We have experienced
termination or cancellation by certain customers in the ordinary
course of business.
The reasons more frequently given for termination include:
|
|
|
| |
• |
the failure of the product being tested to satisfy safety or
efficacy requirements; |
| |
| |
• |
unexpected or undesired clinical results of the product; and |
| |
| |
• |
the client’s decision to forego a particular study. |
From time to time, terminations occur because of:
|
|
|
| |
• |
insufficient patient enrollment or investigator recruitment; |
| |
| |
• |
the client’s decision to downsize its product development
portfolios; |
| |
| |
• |
the client’s dissatisfaction with our performance,
including the quality or accuracy of the data or reports
provided and our ability to meet agreed upon schedules; and |
| |
| |
• |
production problems resulting in shortages of the drug or
required clinical supplies. |
The loss or delay of a program or large
contract or the loss or
delay of multiple smaller
contracts could harm our business
because such terminations could lower our level of staff
utilization, which would reduce our profitability. In addition,
the terminability of our
contracts puts increased pressure on
our quality control efforts, since not only can our
contracts be
terminated by clients as a result of poor performance, but any
such termination also may affect our ability to obtain future
contracts from the client involved and, possibly, others among
the companies that sponsor trials. Because the
contracts
included in our backlog are generally terminable without cause,
we do not believe that our backlog as of any date is necessarily
a meaningful predictor of future results.
Our quarterly operating results may vary, which could
negatively affect the market price of our common stock.
Our quarterly operating results have been and will continue to
be subject to variation, depending on factors such as the
commencement, completion, or cancellation of significant
contracts, the timing of acquisitions, the mix of contracted
services, foreign exchange rate fluctuations, the timing of
start-up expenses for new offices and services, and the costs
associated with integrating acquisitions. We have experienced,
and expect to continue experiencing, some variations in our
revenue due to our customers’ budgetary cycles. As a
result, we believe that quarterly comparisons of our financial
results should not be relied upon as an indication of our future
performance. In addition, quarterly volatility in our operating
results could cause declines in the market price of our common
stock.
9
We depend on a limited number of clients, and a loss of or
significant decrease in business from them could affect our
business.
We have in the past and may in the future derive a significant
portion of our service revenue from a relatively limited number
of clients that vary from year to year. During 2004, 42.8% of
our service revenue was derived from our top five clients.
During 2003, 40.5% of our service revenue was derived from our
top five clients. During 2002, 38.1% of our service revenue was
derived from our top five clients. Our relationships with these
customers involve a substantial number of individual
arrangements detailing the particulars of a given clinical
development project and often implicate different entities,
departments, or companies under common control. Nevertheless,
the loss of, or a significant decrease in business from, one or
more of these clients could harm our business.
Because most of our clinical development service revenue is
from long-term fixed-fee contracts, we would lose money in
performing these contracts if our costs of performing them were
to exceed the fixed fees payable to us.
Because most of our clinical development service revenue is from
long-term fixed-fee
contracts, we bear the risk of cost overruns
under these
contracts. If the costs of completing these projects
exceed the fixed fees for these projects, our business,
financial condition, and operating results could be adversely
affected.
Our business depends on our senior management team, and the
loss of any member of the team may harm our business.
We believe our success will depend on the continued employment
of our senior management team. At the present time, this group
includes: Patrick K. Donnelly, our president and chief executive
officer; David W. Dockhorn, our executive vice president of
global clinical operations; Erich Mohr, our executive vice
president and chief scientific officer; and James C. Powers, our
executive vice president of worldwide business development and
secretary. All of these officers are parties to employment
agreements with us. This management team has significant
experience in the administration of a CRO. If one or more
members of our senior management team were unable or unwilling
to continue in their present positions, those persons could be
difficult to replace and our business could be harmed. We do not
currently maintain key person life insurance policies on any of
our employees. If any of our key employees were to join a
competitor or to form a competing company, some of our clients
might choose to use the services of that competitor or new
company instead of our own. Furthermore, clients or other
companies seeking to develop in-house capabilities may hire away
some of our senior management or key employees.
If we are unable to recruit and retain qualified personnel,
we may not be able to expand our business or remain
competitive.
Because of the specialized scientific nature of our business, we
are highly dependent upon qualified scientific, technical and
managerial personnel. At the present time, approximately 25% of
our workforce holds at least a master’s degree. There is
intense competition for qualified personnel in the
pharmaceutical and biotechnology fields. In the future, we may
not be able to attract and retain the qualified personnel
necessary for the conduct and further development of our
business. The loss of the services of existing personnel, as
well as the failure to recruit additional key scientific,
technical, and managerial personnel in a timely manner, could
harm our ability to expand our business and to remain
competitive in the CRO industry.
Our business could be harmed if we are unable to manage our
growth effectively.
We have experienced rapid growth throughout our operations. We
believe that sustained growth places a strain on operational,
human, and financial resources. To manage our growth, we must
continue to improve our operating and administrative systems and
to attract and retain qualified management, professional,
scientific, and technical operating personnel. We believe that
maintaining and enhancing both our systems and personnel at
reasonable cost are instrumental to our success in the CRO
industry. We cannot assure you that we will be able to enhance
our current technology or obtain new technology that
10
will enable our systems to keep pace with developments and the
sophisticated needs of our clients. The nature and pace of our
growth introduces risks associated with quality control and
client dissatisfaction due to delays in performance or other
problems. In addition, foreign operations involve the additional
risks of assimilating differences in foreign business practices,
hiring and retaining qualified personnel, and overcoming
language barriers. It is also possible that with any future
acquisitions, we will assume the problems of the acquired
entity. Although past acquisitions have not resulted in any
significant integration problems, we anticipate additional
growth in the future and we may face these types of issues.
Failure to manage growth effectively could have an adverse
effect on us.
Our exposure to exchange rate fluctuations could negatively
impact our results of operations.
We derived approximately 36.7% of our consolidated service
revenue in 2004 from our operations outside of the United
States, primarily from our operations in Europe and Canada,
where significant amounts of our revenues and expenses are
recorded in local currency. Our financial statements are
presented in U.S. dollars. Accordingly, changes in currency
exchange rates, particularly among the euro, pound sterling, and
the Canadian dollar, and the U.S. dollar, may cause
fluctuations in our reported financial results that could be
material.
In addition, a portion of our
contracts with our clients are
denominated in currencies other than the currency in which we
incur expenses related to those
contracts. In Canada, our
contracts generally provide for invoicing clients in
U.S. dollars, but our expenses are generally incurred in
Canadian dollars. Where expenses are incurred in currencies
other than those in which
contracts are priced, fluctuations in
the relative value of those currencies could harm our results of
operations.
In the first quarter of 2005, we entered into a number of
foreign currency hedging
contracts to mitigate exposure to
movements between the U.S. dollar and the pound sterling
and the U.S. dollar and the euro. We agreed to purchase a
given amount of pounds sterling and euros at established dates
throughout 2005.
We are subject to certain risks associated with our foreign
operations.
We have offices and conduct business on six continents. Certain
risks are inherent in these international operations.
The risks related to our foreign operations that we more often
face in the normal course of business include:
|
|
|
| |
• |
tax rates in certain foreign countries may exceed those in the
United States, and foreign earnings may be subject to
withholding requirements or the imposition of tariffs, exchange
controls, or other restrictions, including restrictions on
repatriation; and |
| |
| |
• |
general economic and political conditions in countries where we
operate may have an adverse effect on our operations in those
countries. |
Less frequently, we encounter the following risks:
|
|
|
| |
• |
foreign customers may have longer payment cycles than customers
in the United States; |
| |
| |
• |
we may have difficulty complying with a variety of foreign laws
and regulations, some of which may conflict with United States
law; |
| |
| |
• |
the difficulty of enforcing agreements and collecting
receivables through certain foreign legal systems; and |
| |
| |
• |
the difficulties associated with managing a large organization
spread throughout various countries. |
While we have not experienced any major problems to date with
the acquisition or operation of our foreign entities, we may in
the future encounter certain limitations inherent in the
carrying out of clinical development trials internationally,
including establishing effective communications, operating in
various time zones, and dealing with incompatible technology.
11
As we continue to expand our business globally, our success will
be dependent, in part, on our ability to anticipate and
effectively manage these and other risks associated with foreign
operations. We cannot assure you that these and other factors
will not have a material adverse effect on our international
operations or our business, financial condition, or results of
operations as a whole.
We provide services to emerging companies that may be unable
to pay us.
We incur costs in providing drug development services to our
clients before we are paid. We provide drug development services
to biotechnology companies, many of which are early-stage
companies with relatively limited financial resources. If any of
these companies were to cease operations before paying us for
our services, or are otherwise unable to pay, our results of
operations could suffer. We have performed services for two
companies which ceased operations and filed for bankruptcy
protection in 2003 while amounts were still owed to us. The
amounts owed by these customers resulted in our recording
$1.9 million in additional bad debt reserves during fiscal
year 2003.
We have a significant amount of goodwill on our balance
sheet, and a downturn in our business or industry could require
us to take a charge to earnings, which may negatively affect the
market price of our common stock.
Our balance sheet reflects a significant amount of goodwill,
which represented $101.3 million, or approximately 30.0% of
our total assets as of
December 31, 2004. We review the
amount of our goodwill whenever events or changes in
circumstances indicate that the carrying amount of the goodwill
may not be fully recoverable. To determine recoverability, we
annually compare the fair value of our reporting unit (which is
our company) to its carrying value. Although no event has
occurred to date impairing our goodwill, there is a possibility
that the carrying amount of the goodwill could be impaired if
there is a downturn in our business or our industry or other
factors affect the fair value of our business, in which case a
charge to earnings would become necessary.
Our business depends significantly on the continued
effectiveness of our information technology infrastructure, and
failures of such technology could harm our operations.
To remain competitive in our industry, we must employ
information technologies that capture, manage, and analyze the
large streams of data generated during our clinical trials in
compliance with applicable regulatory requirements. In addition,
because we provide services on a global basis, we rely
extensively on our technology to allow the concurrent conduct of
studies and work sharing around the world. As with all
information technology, our system is vulnerable to potential
damage or interruptions from fires, blackouts,
telecommunications failures, and other unexpected events, as
well as to break-ins, sabotage, or intentional acts of
vandalism. Given the extensive reliance of our business on this
technology, any substantial disruption or resulting loss of data
that is not avoided or corrected by our backup measures could
harm our business and operations.
Our business could be harmed if we cannot successfully
integrate future acquisitions.
In the ordinary course of our business, we identify and review
potential acquisition candidates and consider prospective
acquisitions and business combination transactions with other
parties and, from time to time, we may make strategic
acquisitions. Acquisitions involve numerous risks, including the
expenses incurred in connection with the acquisition, the
difficulties in assimilating operations, the diversion of
management’s attention from other business concerns, and
the potential loss of key employees of the acquired company.
Acquisitions of foreign companies involve the additional risks
of assimilating differences in foreign business practices,
hiring and retaining qualified personnel, and overcoming
language barriers. We cannot assure you that we will
successfully integrate future acquisitions into our operations.
We compete in a highly competitive market and if we do not
compete successfully our business could be harmed.
We compete against other CROs and in-house development at large
pharmaceutical companies. Our principal competitors are
traditional CROs, including Charles River Laboratories
International, Inc., Covance Inc., ICON plc, Kendle
International Inc., MDS Inc., Omnicare, Inc., PAREXEL
International Corporation, Pharmaceutical Product Development,
Inc., Quintiles Transnational Corp., SFBC Interna-
12
tional, Inc., and UnitedHealth Group Incorporated. Some of these
competitors have greater capital and other resources than we do
at the present time. As a result of competitive pressures and
the potential for economies of scale, the industry continues to
experience consolidation. This trend, as well as a trend by
pharmaceutical companies and other clients to limit outsourcing
to fewer organizations, in some cases through preferred vendor
relationships, is likely to result in increased worldwide
competition among the larger CROs for clients and acquisition
candidates. We believe that major pharmaceutical and
biotechnology companies have been developing preferred vendor
relationships with full-service CROs, effectively excluding
other CROs from the bidding process. Our preferred vendor
relationships are not contractual and are subject to change at
any time. We may find reduced access to certain potential
clients due to preferred vendor arrangements with other
competitors. In addition, the CRO industry has attracted the
attention of the investment community, and increased potential
financial resources are likely to lead to increased competition
among CROs. There are few barriers to entry for small,
limited-service entities entering the CRO industry, and these
entities also may compete with established CROs for clients. We
address the competition in our industry by continuing to focus
on the quality of our services, maintaining our therapeutic
expertise, and investing in our quality management system.
Nevertheless, increased competition may lead to price and other
forms of competition that could harm our business.
Risks Related to Our Industry
Our business could be harmed if the companies in the
pharmaceutical and biotechnology industries to whom we offer our
services reduce their research and development activities or
reduce the extent to which they outsource clinical
development.
Our business depends upon the ability and willingness of
companies in the pharmaceutical and biotechnology industries to
continue to spend on research and development at rates close to
or at historical levels and to outsource the services we
provide. We are therefore subject to risks, uncertainties, and
trends that affect companies in these industries. For example,
we have benefited to date from the increasing tendency of
pharmaceutical and biotechnology companies to outsource both
small and large clinical development projects. Conversely,
mergers and acquisitions in the pharmaceutical and biotechnology
industries could have an impact on a company’s continued
ability to outsource such projects to CROs. Any general downturn
in the pharmaceutical or biotechnology industries, any reduction
in research and development spending by companies in these
industries, or any expansion of their in-house development
capabilities could materially harm our business, financial
condition, and operating results.
Our business and the businesses of our customers are subject
to extensive regulation, and our results of operations could be
harmed if regulatory standards change significantly or if we
fail to maintain compliance with evolving, complex
regulations.
Laws and regulations regarding the development and approval of
drug and biological products have become increasingly stringent
in both the United States and foreign jurisdictions, resulting
in a need for more complex and often larger clinical studies. We
believe that these trends have created an increased demand for
CRO services from which our business benefits. Human
pharmaceutical products and biological products are subject to
rigorous regulation by the U.S. government (principally by
the Food and Drug Administration, or FDA), and by foreign
governments if products are tested or marketed abroad. A
relaxation of the scope of regulatory requirements, such as the
introduction of simplified marketing applications for
pharmaceuticals and biologics, could decrease the business
opportunities available to us.
In addition, because we offer services relating to the conduct
of clinical trials and the preparation of marketing
applications, we are required to comply with applicable
regulatory requirements governing, among other things, the
design, conduct, performance, monitoring, auditing, recording,
analysis, and reporting of these trials. In the United States,
the FDA governs these activities pursuant to the agency’s
Good Clinical Practice, or GCP, regulations. A failure to
maintain compliance with the GCP or other applicable regulations
could lead to a variety of sanctions, including, among other
things, and depending on the nature of the violation and the
type of product involved, the suspension or termination of a
clinical study, civil penalties, criminal prosecutions, or
debarment from assisting in the submission of new drug
13
applications, or NDAs. While we monitor our clinical trials to
test for compliance with applicable laws and regulations in the
United States and foreign jurisdictions in which we operate, our
business spans multiple regulatory jurisdictions with varying,
complex regulatory frameworks. In addition, although we have
adopted standard operating procedures that are designed to
satisfy regulatory requirements, no system of procedures can
provide complete assurance of achieving our regulatory
compliance objectives in all respects because compliance
involves human diligence and procedures and is subject to human
errors and lapses in judgment. Therefore, we cannot assure you
that our systems ensure regulatory compliance in every instance.
Circumstances beyond our control could cause the CRO industry
to suffer reputational or other harm that could result in an
industry-wide reduction in demand for CRO services, which could
harm our business.
Demand for our services may be affected by perceptions of our
customers regarding the CRO industry as a whole. For example,
other CROs could engage in conduct that could render our
customers less willing to do business with us or any CRO.
Although to date no event has occurred causing industry-wide
reputational harm, one or more CROs could engage in or fail to
detect malfeasance, such as inadequately monitoring sites,
producing inaccurate databases or analysis, falsifying patient
records, and performing incomplete lab work, or take other
actions that would reduce the confidence of our customers in the
CRO industry. As a result, the willingness of pharmaceutical and
biotechnology companies to outsource research and development
services to CROs could diminish and our business could thus be
harmed materially by events outside our control.
If we incur liability for hazardous material contamination,
our business would be harmed.
Our clinical pharmacology unit conducts activities that have
involved, and may continue to involve, the controlled use of
hazardous materials and the creation of hazardous substances or
wastes, including medical waste and other highly regulated
substances. Although we believe that our safety procedures for
handling the disposal of such materials comply with the
standards prescribed by state and federal laws and regulations,
our operations nevertheless pose the risk of accidental
contamination or injury from these materials. In the event of
such an accident, we could be held liable for damages and
cleanup costs which, to the extent not covered by existing
insurance or indemnification, could harm our business. In
addition, other adverse effects could result from such
liability, including reputational damage resulting in the loss
of additional business from certain clients. Our business could
be materially harmed if we were required to pay damages beyond
the level of any insurance coverage that may be in effect. To
date, we have not been the subject of any investigations or
claims related to the controlled use of hazardous materials or
the creation of hazardous substances or wastes.
Our services are subject to evolving industry standards and
rapid technological changes.
The markets for our services are characterized by rapidly
changing technology, evolving industry standards and frequent
introduction of new and enhanced services. To succeed, we must
continue to introduce new services on a timely and
cost-effective basis to meet evolving customer requirements,
while achieving market acceptance for these new services.
Additionally, we must continue to enhance our existing services
and to successfully integrate new services with those already
being offered. It is imperative that we respond to emerging
industry standards and other technological changes. If we fail
to make the necessary enhancements to our business, systems and
products to keep pace with evolving industry standards, our
competitive position and results of operations may suffer.
Our clinical research services create a risk of liability
and, if we are required to pay damages or to bear the costs of
defending any claim not covered by contractual indemnity or
insurance, this could cause material harm to our business.
Clinical research services involve the testing of new drugs,
biologics, and devices on human volunteers. This testing creates
risks of liability for personal injury, sickness or death of
patients resulting from their participation in the study. These
risks include, among other things, unforeseen adverse side
effects, improper application or administration of a new drug,
biologic, or device, and the professional
14
malpractice of medical care providers. Many volunteer patients
already are seriously ill and are at heightened risk of future
illness or death. In connection with our provision of
contract
research services, we
contract with physicians to serve as
investigators in conducting clinical trials on human volunteers.
Although we do not believe we are legally accountable for the
medical care rendered by third party investigators, it is
possible that we could be held liable for the claims and
expenses arising from any professional malpractice of the
investigators with whom we
contract in the event of personal
injury to or death of persons participating in clinical trials.
We also could be held liable for errors or omissions in
connection with the services we perform or for the general risks
associated with our Phase I facility including, but not
limited to, adverse reactions to the administration of drugs.
Our business could be materially harmed if we were required to
pay damages or bear the costs of defending any claim outside the
scope of, or in excess of, the contractual indemnification
provided by our customer that is beyond the level of any
insurance coverage that may be in effect, or if an indemnifying
party does not fulfill its indemnification obligations.
Health care industry reform could reduce or eliminate our
business opportunities.
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. In addition, foreign governments may also
undertake health care reforms in their respective countries.
These reforms, if adopted, would make the development of new
drugs less profitable for our customers, and could reduce their
research and development budgets. Business opportunities
available to us could decrease materially if the implementation
of government health care reform adversely affects research and
development expenditures by pharmaceutical and biotechnology
companies.
Risks Related to this Offering
The price of our common stock may fluctuate significantly,
and you could lose all or part of your investment.
The trading price of our common stock is likely to be volatile,
and such volatility could prevent you from being able to sell
your shares at or above the price you paid for your shares. The
stock market, and the stock of companies in our industry in
particular, has experienced volatility, and this volatility has
often been unrelated to the operating performance of particular
companies. Wide fluctuations in the trading price or volume of
our shares of common stock could be caused by many factors,
including factors relating to our business or to investor
perception of our business (including changes in financial
estimates and recommendations by financial analysts who follow
us), but also factors relating to (or relating to investor
perception of) the drug development services industry, the
pharmaceutical and biotechnology industries, or the economy in
general. Thus, the price of our common stock could fluctuate
based upon factors that have little or nothing to do with our
company, and the fluctuations could result in a material
reduction in our stock price.
The sale of a substantial number of our shares of common
stock in the public market could reduce the market price of our
shares, which in turn could negatively impact your investment in
us.
Future sales of a substantial number of shares of our common
stock in the public market (or the perception that such sales
may occur) could reduce our stock price and could impair our
ability to raise capital through future sales of our equity
securities. Upon completion of this offering, we will have
22,432,891 shares of common stock issued and outstanding.
All of the shares the selling stockholders are selling in this
offering, plus any shares sold upon the exercise of the
underwriters’ over-allotment option, will be freely
tradeable without restriction under the Securities Act of 1933,
or the Securities Act, unless purchased by our affiliates. As of
the date of this prospectus, 8,287,287 shares of our common
stock are available for sale in the public market and an
additional 6,945,604 shares will be available for sale in
the public market at various times after 90 days from the
date of this prospectus. The rules affecting the sale of these
securities are summarized under “Shares Eligible for Future
Sale.” In addition, following this
15
offering, without giving effect to the over-allotment option,
stockholders that collectively own 7,330,046 shares of our
common stock have registration rights with respect to their
shares.
Subject to certain exceptions and extensions described under the
caption “Underwriting,” we and all of our directors
and executive officers and certain of our stockholders have
agreed not to offer, sell or agree to sell, directly or
indirectly, any shares of common stock for a period of
90 days from the date of this prospectus. When this period
expires we and our locked-up stockholders will be able to sell
our shares in the public market, subject to restrictions on
shares held by affiliates. Sales of a substantial number of such
shares upon expiration, or early release, of the lock-up (or the
perception that such sales may occur) could cause our share
price to fall.
Our principal stockholders hold (and following completion of
this offering will continue to hold) shares of our common stock
in which they have a very large unrealized gain, and these
stockholders may wish, to the extent they may permissibly do so,
to realize some or all of that gain relatively quickly by
selling some or all of their shares.
We may also issue shares of our common stock from time to time
as consideration for future acquisitions and investments. If any
such acquisition or investment is significant, the number of
shares that we may issue may in turn be significant. In
addition, we may grant registration rights covering those shares
in connection with any such acquisitions and investments.
In the future, we may sell additional shares of our common stock
to raise capital. We cannot predict the size of future issuances
or the effect, if any, that they may have on the market price of
our common stock. The issuance and sales of substantial amounts
of common stock, or the perception that such issuances and sales
may occur, could adversely affect the market price of our common
stock.
We have implemented certain provisions that could make any
change in our board of directors or in control of our company
more difficult.
Our
certificate of incorporation, our
bylaws and Delaware law
contain provisions, such as provisions authorizing, without a
vote of stockholders, the issuance of one or more series of
preferred stock, that could make it difficult or expensive for a
third party to pursue a tender offer, change in control or
takeover attempt that is opposed by our management and board of
directors even if such a transaction would be beneficial to our
stockholders. We also have a staggered board of directors that
could make it more difficult for stockholders to change the
composition of our board of directors in any one year. These
anti-takeover provisions could substantially impede the ability
of public stockholders to change our management and board of
directors.
Our largest stockholders will continue to have significant
influence over us after this offering, and they may make
decisions with which you disagree.
Following completion of this offering, Genstar Capital
Partners III, L.P., its affiliates and Caisse de depot et
placement du Quebec will beneficially own approximately 20.8% of
the outstanding shares of common stock (or approximately 18.0%
of the shares of common stock on a diluted basis). If these
stockholders choose to act in concert on any action requiring
stockholder approval, they could have a significant influence on
the outcome of such action. The interests of these current
stockholders may conflict with your interests, and we cannot
assure you that they will resolve any such conflict in a manner
with which you agree. In addition, this concentration of
ownership could have the effect of discouraging potential
takeover attempts and may make attempts by stockholders to
change our management more difficult.
Because we typically have not paid dividends and do not
anticipate paying dividends on our common stock for the
indefinite future, you should not expect to receive dividends on
shares of our common stock.
We have no present plans to pay cash dividends to our
stockholders and, for the indefinite future, intend to retain
all of our earnings for use in our business. The declaration of
any future dividends by us is within the discretion of our board
of directors and will be dependent on our earnings, financial
condition, and capital requirements, as well as any other
factors deemed relevant by our board of directors. Although
16
we paid a special dividend to our stockholders in January, 2004,
the dividend was an unusual event that we do not expect to
recur. Accordingly, you should not expect to receive dividends
on shares of our common stock.
Changes in, or interpretations of, accounting rules and
regulations, such as expensing of stock options, could result in
unfavorable accounting charges or require us to change our
compensation policies.
Accounting methods and policies, including policies governing
revenue recognition, expenses, and accounting for stock options
are subject to further review, interpretation, and guidance from
relevant accounting authorities, including the Securities and
Exchange Commission, or SEC. Changes to, or interpretations of,
accounting methods or policies in the future may require us to
reclassify, restate, or otherwise change or revise our financial
statements, including those contained in this prospectus. We
currently are not required to record stock-based compensation
charges if the employee’s stock option exercise price
equals or exceeds the fair value of our common stock at the date
of grant. Although the standards have not been finalized and the
timing of a final statement has not been established, the
Financial Accounting Standards Board has announced its support
for recording expense for the fair value of stock options
granted. If we were to change our accounting policy to record
expense for the fair value of stock options granted and
retroactively restate all prior periods presented, then our
operating expenses would increase. We rely heavily on stock
options to motivate existing employees and to attract new
employees. If we are required to expense stock options, we may
then choose to reduce our reliance on stock options as a
motivation tool. If we reduce our use of stock options, it may
be more difficult for us to attract and retain qualified
employees. If we did not reduce our reliance on stock options,
our reported earnings would decrease.
In December 2004 the FASB issued revised
SFAS No. 123(R),
“Share-Based Payment.”
SFAS 123(R) requires that a public entity measure and
recognize in the statement of operations the cost of
equity-based service awards based on the grant-date fair value
of the award. That cost will be recognized over the period
during which an employee is required to provide service in
exchange for the award or the vesting period. No compensation
cost is recognized for equity instruments for which employees do
not render the requisite service. Adoption of SFAS 123(R)
is required for fiscal years beginning after
June 15, 2005.
We are evaluating the impact of SFAS 123(R), including the
transition alternatives available to us, and believe it will
reduce operating earnings after adoption, but that it will not
impact our financial position or cash flows.
17
CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
Our disclosure and analysis in this prospectus concerning our
operations, cash flows, and financial position, including, in
particular, the likelihood of our success in developing and
expanding our business and the realization of sales from our
backlog, include forward-looking statements. Statements that are
predictive in nature, that depend upon or refer to future events
or conditions, or that include words such as
“expects,” “anticipates,”
“intends,” “plans,” “believes,”
“estimates,” and similar expressions are
forward-looking statements. Although these statements are based
upon assumptions we believe to be reasonable based upon
available information, including projections of
contracts,
revenues, operating margins, earnings, cash flow, research and
development costs, working capital, and capital expenditures,
they are subject to risks and uncertainties that are described
more fully in this prospectus in the section titled
“Risk
Factors.” These forward-looking statements represent our
estimates and assumptions only as of the date of this prospectus
and are not intended to give any assurance as to future results.
As a result, you should not place undue reliance on any
forward-looking statements. We assume no obligation to update
any forward-looking statements to reflect actual results,
changes in assumptions or changes in other factors, except as
required by applicable securities laws. Factors that might cause
future results to differ include, but are not limited to, the
following:
|
|
|
| |
• |
the timing of the initiation, progress or cancellation of
significant projects; |
| |
| |
• |
the mix and timing of services sold in a particular period; |
| |
| |
• |
our need to balance the recruitment and retention of experienced
personnel and associated costs with the maintenance of high
labor utilization; |
| |
| |
• |
rapid technological change and the timing and amount of start-up
costs incurred in connection with the introduction of new
services; |
| |
| |
• |
our dependence on a small number of industries and clients; |
| |
| |
• |
impairment of intangible assets; |
| |
| |
• |
the timing of the opening of new offices; |
| |
| |
• |
the timing of other internal expansion costs; |
| |
| |
• |
the timing and amount of costs associated with integrating
acquisitions; |
| |
| |
• |
exchange rate fluctuations between periods; |
| |
| |
• |
changes in our management; |
| |
| |
• |
changes in estimates of taxable income or utilization of
deferred tax assets in foreign jurisdictions which could
significantly affect our effective tax rate; and |
| |
| |
• |
general economic and business conditions. |
18
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of shares
of our common stock by the selling stockholders in this
offering. However, we are obligated to pay certain expenses
incurred in connection with this offering. The selling
stockholders will receive all of the net proceeds from this
offering.
PRICE RANGE OF COMMON STOCK
Our common stock is currently traded on The Nasdaq National
Market under the symbol
“PRAI.” Prior to
November 18, 2004, no established public trading market for
the common stock existed.
As of
May 15, 2005, there were approximately 100 holders of
record of shares of our common stock.
The table below shows, for the quarters indicated, the reported
high and low trading prices of our common stock on The Nasdaq
National Market:
| |
|
|
|
|
|
|
|
|
| |
|
High | |
|
Low | |
| |
|
| |
|
| |
|
Calendar Year 2004
|
|
|
|
|
|
|
|
|
|
|
|
$ |
24.97 |
|
|
$ |
19.00 |
|
|
Calendar Year 2005
|
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$ |
28.30 |
|
|
$ |
22.26 |
|
|
|
|
$ |
27.25 |
|
|
$ |
23.15 |
|
As of
June 14, 2005, the closing price of our common stock
was $23.75.
DIVIDEND POLICY
We intend to retain all future earnings, if any, for use in the
operation of our business and to fund future growth. We do not
anticipate paying any dividends for the foreseeable future. The
decision whether to pay dividends will be made by our board of
directors in light of conditions then existing, including
factors such as our results of operations, financial condition
and requirements, business conditions, and covenants under any
applicable contractual arrangements. In addition, our revolving
credit facility restricts our ability to pay dividends under
certain circumstances.
In January 2004, our board of directors declared a
$0.94 per share dividend payable to all stockholders and a
$0.94 per option bonus to all current employee option
holders, or a total of approximately $19.6 million. The
dividend and option bonuses were paid during 2004.
19
CAPITALIZATION
The following table sets forth our unaudited cash and cash
equivalents and capitalization as of
March 31, 2005:
You should read this table in conjunction with the consolidated
financial statements and the related notes and
“Management’s Discussion and Analysis of Financial
Condition and Results of Operations.”
| |
|
|
|
|
|
|
| |
|
As of | |
| |
|
March 31, | |
| |
|
2005 | |
| |
|
| |
| |
|
(dollars in | |
| |
|
thousands) | |
|
Cash and cash equivalents
|
|
$ |
68,996 |
|
| |
|
|
|
|
Current portion of capital leases
|
|
$ |
140 |
|
|
Long-term debt:
|
|
|
|
|
| |
Revolving credit facility(1)
|
|
|
— |
|
|
Capital leases
|
|
|
36 |
|
| |
|
|
|
| |
|
Total long-term debt and capital leases, net of current portion
|
|
|
36 |
|
| |
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
| |
Common stock, $0.01 par value, 36,000,000 shares
authorized, 22,378,199 shares issued and outstanding(2)
|
|
|
224 |
|
| |
Treasury stock
|
|
|
(93 |
) |
| |
Additional paid-in capital—common stock
|
|
|
124,832 |
|
| |
Accumulated other comprehensive income
|
|
|
3,121 |
|
| |
Retained earnings
|
|
|
29,612 |
|
| |
|
|
|
| |
|
Total stockholders’ equity
|
|
|
157,696 |
|
| |
|
|
|
| |
|
Total capitalization
|
|
$ |
157,872 |
|
| |
|
|
|
|
|
| (1) |
In December 2004, we entered into a revolving credit facility
with aggregate availability (including letters of credit) of
$75.0 million. To date, we have not drawn any amount of
indebtedness under our revolving credit facility. |
| |
| (2) |
Between April 1, 2005 and May 15, 2005, options for
4,292 shares were exercised. Total outstanding shares at
May 15, 2005 were 22,382,491. |
20
SELECTED CONSOLIDATED FINANCIAL DATA
The following table sets forth our selected consolidated
financial data. We derived the selected consolidated financial
data for the years ended
December 31, 2002,
2003, and
2004
and balance sheet data at
December 31, 2003 and
2004 from
our audited consolidated financial statements and related notes
included elsewhere in this prospectus. We have derived the
selected consolidated financial data as of
December 31,
2000,
2001, and
2002 and for the two years ended
December 31, 2001 from our audited consolidated financial
statements and related notes, which are not included in this
prospectus. We have derived our selected consolidated financial
data as of
March 31, 2005 and for the three months ended
March 31, 2004 and
2005 from our unaudited interim
consolidated financial statements and related notes included
elsewhere in this prospectus. In our opinion, the unaudited
interim consolidated financial statements have been prepared on
the same basis as our audited consolidated financial statements
and include all adjustments, consisting of only normal,
recurring adjustments, necessary for a fair statement of the
results for the unaudited interim periods. The results for any
interim period are not necessarily indicative of the results
that may be obtained for a full fiscal year. The selected
consolidated financial data set forth below are not necessarily
indicative of the results of future operations and should be
read in conjunction with the discussion under the heading
“Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and the consolidated
financial statements and accompanying notes included elsewhere
in this prospectus.
PRA International acquired its operating
subsidiaries on
June 28, 2001 in a business combination accounted for using
the purchase method of accounting. Accordingly, the financial
data set forth below includes a predecessor basis and a
successor basis. As a result of the acquisition, the acquired
assets and liabilities were adjusted to their estimated fair
values. In addition, our statements of operations for the
successor include interest expense resulting from indebtedness
incurred to finance the acquisition, amortization of intangible
assets related to the acquisition, and management fees that did
not exist prior to the acquisition. Therefore, our successor
basis financial data generally are not comparable to our
predecessor basis financial data.
On
January 23, 2004, we closed our $25.0 million
tender offer and special dividend/employee option bonus
transaction. We repurchased $0.1 million of shares and
$3.7 million of our outstanding vested stock options, paid
a $16.9 million special dividend to our stockholders, and
paid a $2.7 million special bonus to employee option
holders. The remainder of the $25.0 million was used to pay
fees associated with the transaction. The funds for the
transaction were provided by the
December 23, 2003
refinancing of our credit facilities. During 2004, we expensed
the $3.7 million attributed to the repurchase of vested
stock options and $2.7 million attributed to the special
bonus to employee holders of vested stock options.
21
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|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Predecessor | |
|
|
Successor | |
| |
|
| |
|
|
| |
| |
|
|
|
Period from | |
|
|
Period from | |
|
|
|
|
| |
|
|
|
January 1, | |
|
|
June 28, | |
|
|
|
Three Months Ended | |
| |
|
Year Ended | |
|
2001 to | |
|
|
2001 to | |
|
Year Ended December 31, | |
|
March 31, | |
| |
|
December 31, | |
|
June 27, | |
|
|
December 31, | |
|
| |
|
| |
| |
|
2000 | |
|
2001 | |
|
|
2001 | |
|
2002 | |
|
2003 | |
|
2004 | |
|
2004 | |
|
2005 | |
| |
|
| |
|
| |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
| |
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
(unaudited) | |
| |
|
(dollars in thousands, | |
|
|
|
|
|
|
|
| |
|
except per share data) | |
|
|
|
|
(dollars in thousands, except per share data) | |
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Service revenue
|
|
$ |
99,136 |
|
|
$ |
55,477 |
|
|
|
$ |
59,600 |
|
|
$ |
176,365 |
|
|
$ |
247,888 |
|
|
$ |
277,479 |
|
|
$ |
66,830 |
|
|
$ |
73,592 |
|
| |
Reimbursement revenue
|
|
|
14,672 |
|
|
|
7,491 |
|
|
|
|
8,316 |
|
|
|
24,648 |
|
|
|
42,109 |
|
|
|
30,165 |
|
|
|
6,965 |
|
|
|
7,859 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Total revenue
|
|
|
113,808 |
|
|
|
62,968 |
|
|
|
|
67,916 |
|
|
|
201,013 |
|
|
|
289,997 |
|
|
|
307,644 |
|
|
|
73,795 |
|
|
|
81,451 |
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Direct costs
|
|
|
53,711 |
|
|
|
29,078 |
|
|
|
|
31,008 |
|
|
|
94,761 |
|
|
|
126,501 |
|
|
|
134,067 |
|
|
|
32,771 |
|
|
|
35,277 |
|
| |
Reimbursable out-of-pocket costs
|
|
|
14,672 |
|
|
|
7,491 |
|
|
|
|
8,316 |
|
|
|
24,648 |
|
|
|
42,109 |
|
|
|
30,165 |
|
|
|
6,965 |
|
|
|
7,859 |
|
| |
Selling, general, and administrative
|
|
|
33,707 |
|
|
|
19,548 |
|
|
|
|
19,903 |
|
|
|
57,897 |
|
|
|
80,585 |
|
|
|
90,139 |
|
|
|
21,993 |
|
|
|
24,380 |
|
| |
Depreciation and amortization
|
|
|
4,359 |
|
|
|
2,244 |
|
|
|
|
5,016 |
|
|
|
6,956 |
|
|
|
8,967 |
|
|
|
9,691 |
|
|
|
2,337 |
|
|
|
2,776 |
|
| |
Merger costs(1)
|
|
|
— |
|
|
|
1,000 |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
| |
Management fee
|
|
|
— |
|
|
|
— |
|
|
|
|
396 |
|
|
|
800 |
|
|
|
800 |
|
|
|
704 |
|
|
|
200 |
|
|
|
— |
|
| |
Option repurchase
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
3,713 |
|
|
|
3,713 |
|
|
|
— |
|
| |
Vested option bonus
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,738 |
|
|
|
1,551 |
|
|
|
— |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations
|
|
|
7,359 |
|
|
|
3,607 |
|
|
|
|
3,277 |
|
|
|
15,951 |
|
|
|
31,035 |
|
|
|
36,427 |
|
|
|
4,265 |
|
|
|
11,159 |
|
|
Interest income (expense), net
|
|
|
(909 |
) |
|
|
(158 |
) |
|
|
|
(2,279 |
) |
|
|
(4,100 |
) |
|
|
(6,856 |
) |
|
|
(3,643 |
) |
|
|
(775 |
) |
|
|
89 |
|
|
Other income (expenses), net
|
|
|
353 |
|
|
|
53 |
|
|
|
|
13 |
|
|
|
(721 |
) |
|
|
(4,023 |
) |
|
|
(38 |
) |
|
|
452 |
|
|
|
(26 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
|
6,803 |
|
|
|
3,502 |
|
|
|
|
1,011 |
|
|
|
11,130 |
|
|
|
20,156 |
|
|
|
32,746 |
|
|
|
3,942 |
|
|
|
11,222 |
|
|
Provision for income taxes
|
|
|
3,298 |
|
|
|
1,751 |
|
|
|
|
1,139 |
|
|
|
5,493 |
|
|
|
6,909 |
|
|
|
11,997 |
|
|
|
1,585 |
|
|
|
4,264 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$ |
3,505 |
|
|
$ |
1,751 |
|
|
|
$ |
(128 |
) |
|
$ |
5,637 |
|
|
$ |
13,247 |
|
|
$ |
20,749 |
|
|
$ |
2,357 |
|
|
$ |
6,958 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Basic
|
|
|
$0.50 |
|
|
$ |
0.25 |
|
|
|
$ |
(0.01 |
) |
|
$ |
0.37 |
|
|
$ |
0.83 |
|
|
$ |
1.13 |
|
|
$ |
0.13 |
|
|
$ |
0.31 |
|
| |
Diluted
|
|
|
0.37 |
|
|
$ |
0.21 |
|
|
|
$ |
(0.01 |
) |
|
$ |
0.32 |
|
|
$ |
0.71 |
|
|
$ |
1.02 |
|
|
$ |
0.12 |
|
|
$ |
0.28 |
|
|
Shares used to compute net income per share(2)(3):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Basic
|
|
|
3,300,859 |
|
|
|
3,301,574 |
|
|
|
|
13,965,364 |
|
|
|
15,204,232 |
|
|
|
15,965,408 |
|
|
|
18,442,313 |
|
|
|
17,652,866 |
|
|
|
22,365,579 |
|
| |
Diluted
|
|
|
4,445,284 |
|
|
|
3,968,335 |
|
|
|
|
13,965,364 |
|
|
|
17,557,632 |
|
|
|
18,666,012 |
|
|
|
20,329,852 |
|
|
|
19,856,877 |
|
|
|
24,625,539 |
|
|
Other Financial Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities
|
|
$ |
10,264 |
|
|
$ |
5,394 |
|
|
|
$ |
21,332 |
|
|
$ |
28,442 |
|
|
$ |
2,058 |
|
|
$ |
71,636 |
|
|
$ |
1,988 |
|
|
$ |
(19,492 |
) |
|
Net cash provided by (used in) investing activities
|
|
|
(3,895 |
) |
|
|
(3,238 |
) |
|
|
|
(2,721 |
) |
|
|
(24,625 |
) |
|
|
(9,599 |
) |
|
|
(32,350 |
) |
|
|
(1,532 |
) |
|
|
22,485 |
|
|
Net cash provided by (used in) financing activities
|
|
|
(2,987 |
) |
|
|
128 |
|
|
|
|
(995 |
) |
|
|
(14,581 |
) |
|
|
26,028 |
|
|
|
(6,430 |
) |
|
|
(18,087 |
) |
|
|
48 |
|
|
Non-GAAP Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted EBITDA(4)
|
|
$ |
12,071 |
|
|
$ |
5,904 |
|
|
|
$ |
8,306 |
|
|
$ |
22,186 |
|
|
$ |
35,979 |
|
|
$ |
52,531 |
|
|
$ |
12,318 |
|
|
$ |
13,909 |
|
|
Adjusted EBITDA as a % of service revenue
|
|
|
12.2 |
% |
|
|
10.6 |
% |
|
|
|
13.9 |
% |
|
|
12.6 |
% |
|
|
14.5 |
% |
|
|
18.9 |
% |
|
|
18.4 |
% |
|
|
18.9 |
% |
|
EBITDA(4)
|
|
$ |
12,071 |
|
|
$ |
5,904 |
|
|
|
$ |
8,306 |
|
|
$ |
22,186 |
|
|
$ |
35,979 |
|
|
$ |
46,080 |
|
|
$ |
7,054 |
|
|
$ |
13,909 |
|
|
EBITDA as a % of service revenue
|
|
|
12.2 |
% |
|
|
10.6 |
% |
|
|
|
13.9 |
% |
|
|
12.6 |
% |
|
|
14.5 |
% |
|
|
16.6 |
% |
|
|
10.6 |
% |
|
|
18.9 |
% |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Predecessor | |
|
|
Successor | |
| |
|
| |
|
|
| |
| |
|
As of | |
|
|
|
|
As of | |
| |
|
December 31, | |
|
|
As of December 31, | |
|
March 31, | |
| |
|
| |
|
|
| |
|
| |
| |
|
2000 | |
|
|
2001 | |
|
2002 | |
|
2003 | |
|
2004 | |
|
2005 | |
| |
|
| |
|
|
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(dollars in | |
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
| |
|
thousands) | |
|
|
|
| |
|
|
|
|
(dollars in thousands) | |
|
Consolidated Balance Sheet Data (end of period):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
3,885 |
|
|
|
$ |
23,712 |
|
|
$ |
13,798 |
|
|
$ |
32,328 |
|
|
$ |
65,888 |
|
|
$ |
68,996 |
|
|
Marketable securities
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
24,500 |
|
|
|
— |
|
|
Working capital
|
|
|
(4,204 |
) |
|
|
|
(5,279 |
) |
|
|
(43,429 |
) |
|
|
(8,449 |
) |
|
|
11,478 |
|
|
|
19,542 |
|
|
Total assets
|
|
|
77,111 |
|
|
|
|
180,261 |
|
|
|
254,547 |
|
|
|
298,558 |
|
|
|
337,344 |
|
|
|
314,151 |
|
|
Long-term debt and capital leases, less current maturities
|
|
|
4,533 |
|
|
|
|
44,437 |
|
|
|
32,509 |
|
|
|
57,810 |
|
|
|
75 |
|
|
|
36 |
|
|
Stockholders’ equity
|
|
|
16,409 |
|
|
|
|
43,253 |
|
|
|
59,088 |
|
|
|
74,565 |
|
|
|
150,379 |
|
|
|
157,696 |
|
|
|
| (1) |
Consists of payments to management in connection with our June
2001 recapitalization. |
| |
| (2) |
Net income (loss) per share and shares used to compute net
income (loss) per share for 2000 and 2001 are presented on an
unaudited basis. Net income (loss) per share includes
$1.8 million for 2000 and $0.9 million for the period
from January 1, 2001 to June 27, 2001 for dividends
and accretion on preferred stock, which reduces net income
available to common stockholders. |
| |
| (3) |
Net income (loss) per share and shares used to compare net
income (loss) per share for all periods following the
predecessor period reflect a four-for-one stock split of our
common stock effected prior to completion of our initial public
offering. |
| |
| (4) |
Adjusted EBITDA and EBITDA are not substitutes for operating
income, net income, or cash flow from operating activities as
determined in accordance with GAAP as measures of performance or
liquidity. See “Non-GAAP Financial Measures.” For each
of the periods indicated, the following table sets forth a
reconciliation of EBITDA and Adjusted EBITDA to net income
(loss) and to net cash provided by (used in) operating
activities. |
22
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Predecessor | |
|
|
Successor | |
| |
|
| |
|
|
| |
| |
|
|
|
Period from | |
|
|
|
|
|
| |
|
|
|
January 1, | |
|
|
Period from | |
|
|
|
Three Months Ended | |
| |
|
Year Ended | |
|
2001 to | |
|
|
June 28, 2001 to | |
|
Year Ended December 31, | |
|
March 31, | |
| |
|
December 31, | |
|
June 27, | |
|
|
December 31, | |
|
| |
|
| |
| |
|
2000 | |
|
2001 | |
|
|
2001 | |
|
2002 | |
|
2003 | |
|
2004 | |
|
2004 | |
|
2005 | |
| |
|
| |
|
| |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
(unaudited) | |
| |
|
(dollars in thousands) | |
|
|
(dollars in thousands) | |
|
Adjusted EBITDA
|
|
$ |
12,071 |
|
|
$ |
5,904 |
|
|
|
$ |
8,306 |
|
|
$ |
22,186 |
|
|
$ |
35,979 |
|
|
$ |
52,531 |
|
|
$ |
12,318 |
|
|
$ |
13,909 |
|
| |
Option repurchase
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(3,713 |
) |
|
|
(3,713 |
) |
|
|
— |
|
| |
Vested option bonus
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,738 |
) |
|
|
(1,551 |
) |
|
|
— |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EBITDA
|
|
|
12,071 |
|
|
|
5,904 |
|
|
|
|
8,306 |
|
|
|
22,186 |
|
|
|
35,979 |
|
|
|
46,080 |
|
|
|
7,054 |
|
|
|
13,909 |
|
| |
Depreciation and amortization
|
|
|
(4,359 |
) |
|
|
(2,244 |
) |
|
|
|
(5,016 |
) |
|
|
(6,956 |
) |
|
|
(8,967 |
) |
|
|
(9,691 |
) |
|
|
(2,337 |
) |
|
|
(2,776 |
) |
| |
Interest income (expense), net
|
|
|
(909 |
) |
|
|
(158 |
) |
|
|
|
(2,279 |
) |
|
|
(4,100 |
) |
|
|
(6,856 |
) |
|
|
(3,643 |
) |
|
|
(775 |
) |
|
|
89 |
|
| |
Provision for income taxes
|
|
|
(3,298 |
) |
|
|
(1,751 |
) |
|
|
|
(1,139 |
) |
|
|
(5,493 |
) |
|
|
(6,909 |
) |
|
|
(11,997 |
) |
|
|
(1,585 |
) |
|
|
(4,264 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
|
3,505 |
|
|
|
1,751 |
|
|
|
|
(128 |
) |
|
|
5,637 |
|
|
|
13,247 |
|
|
|
20,749 |
|
|
|
2,357 |
|
|
|
6,958 |
|
| |
Depreciation and amortization
|
|
|
4,359 |
|
|
|
2,244 |
|
|
|
|
5,016 |
|
|
|
6,956 |
|
|
|
8,967 |
|
|
|
9,691 |
|
|
|
2,337 |
|
|
|
2,776 |
|
| |
Provision for doubtful receivables
|
|
|
— |
|
|
|
250 |
|
|
|
|
76 |
|
|
|
1,888 |
|
|
|
4,851 |
|
|
|
1,914 |
|
|
|
509 |
|
|
|
87 |
|
| |
Amortization of debt discount
|
|
|
54 |
|
|
|
— |
|
|
|
|
126 |
|
|
|
379 |
|
|
|
1,642 |
|
|
|
— |
|
|
|
58 |
|
|
|
— |
|
| |
Stock-based compensation
|
|
|
33 |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
| |
Provision for deferred income taxes
|
|
|
(1,551 |
) |
|
|
612 |
|
|
|
|
(2,672 |
) |
|
|
(1,228 |
) |
|
|
(3,997 |
) |
|
|
2,606 |
|
|
|
3 |
|
|
|
(580 |
) |
| |
Debt issuance costs write-off
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
750 |
|
|
|
1,241 |
|
|
|
— |
|
|
|
— |
|
| |
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Accounts receivable and unbilled services
|
|
|
(12,944 |
) |
|
|
5,794 |
|
|
|
|
(8,711 |
) |
|
|
(29,251 |
) |
|
|
(18,538 |
) |
|
|
15,373 |
|
|
|
240 |
|
|
|
2,057 |
|
| |
|
Prepaid expenses and other assets
|
|
|
(1,579 |
) |
|
|
(5,187 |
) |
|
|
|
2,934 |
|
|
|
1,444 |
|
|
|
408 |
|
|
|
1,226 |
|
|
|
(2,570 |
) |
|
|
(2,400 |
) |
| |
|
Accounts payable and accrued expenses
|
|
|
(1,438 |
) |
|
|
4,330 |
|
|
|
|
452 |
|
|
|
3,481 |
|
|
|
(4,873 |
) |
|
|
7,793 |
|
|
|
(4,810 |
) |
|
|
(7,846 |
) |
| |
|
Income taxes
|
|
|
788 |
|
|
|
(1,605 |
) |
|
|
|
434 |
|
|
|
989 |
|
|
|
(481 |
) |
|
|
12,150 |
|
|
|
1,393 |
|
|
|
(2,525 |
) |
| |
|
Advance billings
|
|
|
19,037 |
|
|
|
(2,795 |
) |
|
|
|
23,805 |
|
|
|
38,147 |
|
|
|
82 |
|
|
|
(1,107 |
) |
|
|
2,471 |
|
|
|
(18,019 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities
|
|
$ |
10,264 |
|
|
$ |
5,394 |
|
|
|
$ |
21,332 |
|
|
$ |
28,442 |
|
|
$ |
2,058 |
|
|
$ |
71,636 |
|
|
$ |
1,988 |
|
|
$ |
(19,492 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23
NON-GAAP FINANCIAL MEASURES
EBITDA and Adjusted EBITDA are measures of our performance that
are not required by, or presented in accordance with, GAAP.
Neither EBITDA nor Adjusted EBITDA should be considered as an
alternative to net income, operating income, or any other
performance measures derived in accordance with GAAP or as an
alternative to cash flow from operating activities as a measure
of our liquidity.
EBITDA represents net income before interest, taxes,
depreciation, and amortization. We use EBITDA to facilitate
operating performance comparisons from period to period. In
addition, we believe EBITDA facilitates company to company
comparisons by backing out potential differences caused by
variations in capital structures (affecting interest expense),
taxation, and the age and book depreciation of facilities and
equipment (affecting relative depreciation expense), which may
vary for different companies for reasons unrelated to operating
performance. We also use EBITDA, and we believe that others in
our industry use EBITDA, to evaluate and price potential
acquisition candidates. We further believe that EBITDA is
frequently used by securities analysts, investors, and other
interested parties in the evaluation of issuers, many of which
present EBITDA when reporting their results.
In addition to EBITDA, we use a measure that we call Adjusted
EBITDA, which we define as EBITDA adjusted to exclude the
effects of a one-time $25.0 million tender offer
specifically relating to the repurchase of our outstanding
vested stock options and the payment of a special bonus to
employee option holders. In addition to our GAAP results and our
EBITDA, we use Adjusted EBITDA to manage our business. Adjusted
EBITDA is not a uniformly defined measure and varies among
companies that use such a measure.
Our management uses Adjusted EBITDA as a measure to assess our
performance. In addition, the covenants in the revolving credit
facility under which we financed the option repurchase define
EBITDA to exclude certain charges relating to the option
repurchases, and we report Adjusted EBITDA in a manner
consistent with the requirements of our revolving credit
facility. We use Adjusted EBITDA as a performance measure
because it excludes the effects of a special non-recurring
transaction undertaken for the purpose of reducing our option
overhang as part of a restructuring whose costs are not viewed
by our management as indicative of the status of our ongoing
operating performance. All charges relating to this
restructuring transaction were incurred in 2004.
Each of EBITDA and Adjusted EBITDA has limitations as an
analytical tool, and you should not consider either of these
measures in isolation, or as a substitute for analysis of our
results as reported under GAAP. For example, EBITDA and Adjusted
EBITDA do not reflect:
|
|
|
| |
• |
our cash expenditures, or future requirements, for capital
expenditures or contractual commitments; |
| |
| |
• |
changes in, or cash requirements for, our working capital needs; |
| |
| |
• |
our significant interest expense, or the cash requirements
necessary to service interest and principal payments on our
debts; |
| |
| |
• |
any cash requirements for the replacement of assets being
depreciated and amortized, which will often have to be replaced
in the future, even though depreciation and amortization are
non-cash charges; and |
| |
| |
• |
the fact that other companies in our industry may calculate
EBITDA and Adjusted EBITDA differently than we do, which limits
their usefulness as comparative measures. |
Because of these limitations, neither EBITDA nor Adjusted EBITDA
should be considered as a measure of discretionary cash
available to us to invest in the growth of our business. We
compensate for these limitations by relying primarily on our
GAAP results and by using EBITDA and Adjusted EBITDA only
supplementally.
24
MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis
together with “Selected Consolidated Financial Data”
and our consolidated financial statements and related notes
included in this prospectus. The discussion in this prospectus
contains forward-looking statements that involve risks and
uncertainties, such as statements of our plans, objectives,
expectations, and intentions. The cautionary statements made in
this prospectus should be read as applying to all related
forward-looking statements wherever they appear in this
prospectus. Our actual results could differ materially from
those discussed here. Factors that could cause or contribute to
these differences include those discussed in “Risk
Factors,” as well as those discussed elsewhere in this
prospectus. You should read “Risk Factors” and
“Cautionary Notice Regarding Forward-Looking
Statements.”
Overview
We provide clinical drug development services on a
contract
basis to biotechnology and pharmaceutical companies worldwide.
We conduct clinical trials globally and are one of a limited
number of CROs with the capability to serve the growing need of
pharmaceutical and biotechnology companies to conduct complex
clinical trials in multiple geographies concurrently. We offer
our clients high-quality services designed to provide data to
clients as rapidly as possible and reduce product development
time. We believe our services enable our clients to introduce
their products into the marketplace faster and, as a result,
maximize the period of market exclusivity and monetary return on
their research and development investments. Additionally, our
comprehensive services and broad experience provide our clients
with a variable cost alternative to fixed cost internal
development capabilities.
Contracts determine our relationships with clients in the
pharmaceutical and biotechnology industries and establish the
way we are to earn revenue. Two types of relationships are most
common: a fixed-price
contract or a time and materials
contract.
The duration of our
contracts ranges from a few months to
several years. A fixed-price
contract typically requires a
portion of the
contract fee to be paid at the time the
contract
is entered into and the balance is received in installments over
the
contract’s duration, in most cases when certain
performance targets or milestones are reached. Service revenue
from fixed-price
contracts is generally recognized on a
proportional performance basis, measured principally by the
total costs incurred as a percentage of estimated total costs
for each
contract. We also perform work under time and materials
contracts, recognizing service revenue as hours are incurred,
which is then multiplied by the contractual billing rate. Our
costs consist of expenses necessary to carry out the clinical
development project undertaken by us on behalf of the client.
These costs primarily include the expense of obtaining
appropriately qualified labor to administer the project, which
we refer to as direct cost headcount. Other costs we incur are
attributable to the expense of operating our business generally,
such as leases and maintenance of information technology and
equipment.
We review various financial and operational metrics, including
service revenue, margins, earnings, new business awards, and
backlog to evaluate our financial performance. Our service
revenue was $176.4 million in 2002, $247.9 million in
2003 and $277.5 million in 2004. Once contracted work
begins, service revenue is recognized over the life of the
contract as services are performed. We commence service revenue
recognition when a
contract is signed or when we receive a
signed letter of intent.
Our new business awards during the years ended
December 31,
2002,
2003, and
2004 were $287.7 million,
$317.4 million and $427.4 million, respectively. New
business awards arise when a client selects us to execute its
trial and so indicates by written or electronic correspondence.
The number of new business awards can vary significantly from
quarter to quarter, and awards can have terms ranging from
several months to several years. The value of a new award is the
anticipated service revenue over the life of the
contract, which
does not include reimbursement activity or investigator fees.
Our backlog consists of anticipated service revenue from new
business awards that either have not started but are anticipated
to begin in the near future or are
contracts in process that
have not been
25
completed. Backlog varies from period to period depending upon
new business awards and
contract increases, cancellations, and
the amount of service revenue recognized under existing
contracts. Our backlog at
December 31, 2002,
2003, and
2004
was $327.0 million, $360.6 million and
$448.8 million, respectively.
From 2002 to 2004, our service revenue grew 57.3%, and our
backlog grew 37.2%. This growth resulted primarily from an
increase in our global projects. Global projects are typically
larger in scope and increased from 14 projects in 2001 to 47 in
2004.
Income from operations was $16.0 million in 2002,
$31.0 million in 2003 and $36.4 million in 2004. This
growth reflects improved productivity and the impact of
acquisitions. We attribute the improvement in productivity to
rapid integration of our acquisitions and management initiatives
focused on management support information and reduction of
employee turnover. Service revenue growth from 2002 to 2004 of
57.3% outpaced direct costs headcount growth of 8.3% for the
same period.
During the three-year period ended
December 31, 2004, we
expanded our operations in part through four strategic
acquisitions, which were funded from cash generated from
operating activities and the issuance of equity securities.
On
April 19, 2002, we acquired all of the outstanding
equity of Staticon International España, S.A., based in
Madrid, Spain. Staticon augmented our capabilities in clinical
trials management, data management, and medical writing services
and added operations in Spain and Portugal. We paid
approximately $3.3 million in cash and equity securities.
On
June 19, 2002, we acquired all of the outstanding equity
of CroMedica International Inc., based in Victoria, Canada.
CroMedica augmented our capabilities in CNS clinical development
and added operations in North America, South America, Africa,
and Australia. We paid approximately $25.3 million in cash
and equity securities.
On
October 8, 2003, we acquired all of the assets of
Valid-Trio GmbH. These assets mainly comprised Valid-Trio’s
business operated through its branch in Moscow, Russia.
Valid-Trio expanded our capabilities to conduct clinical trials
in Russia, Ukraine, Romania, and bordering countries. We paid
$0.2 million in cash.
On
December 1, 2003, we acquired all of the outstanding
equity of ClinCare Consulting BVBA, based in Brussels, Belgium.
ClinCare strengthened our capabilities in cardiovascular, CNS,
oncology, and rheumatology clinical development and expanded our
operations in Belgium. We paid approximately $2.8 million
in cash and equity securities, net of cash acquired.
Based on detailed pre-closing integration plans, each of these
acquisitions was fully integrated and right-sized within
100 days of the closing. These plans facilitated the
immediate and seamless integration of each acquisition into our
operating systems and procedures from the effective date of the
acquisition.
During the years ended
December 31, 2002,
2003, and
2004,
we paid a management fee to Genstar Capital, L.P., an affiliate
of our principal stockholder, totaling $0.8 million,
$0.8 million, and $0.7 million, respectively.
Subsequent to our initial public offering in November 2004, we
ceased paying this management fee. However, as a public company,
we are subject to financial reporting compliance costs that we
have not previously had to pay, which we estimate will more than
offset the savings from the discontinuation of the management
fee.
On
April 1, 2005, we acquired all of the outstanding equity
of GMG BioBusiness Ltd., based outside London, England. GMG
enhances our existing multinational service offerings in our
Global Regulatory Affairs group and our strategy, while bringing
additional global experience. We paid $2.3 million in cash
and assumed liabilities with an additional cash payment of
$0.7 million over three years if certain performance
measures are met.
On
June 1, 2005 we acquired all of the outstanding equity
of Regulatory/ Clinical Consultants, Inc. based in Lee’s
Summit, Missouri. This acquisition solidifies our strategy to
strengthen the regulatory service offerings of our Global
Regulatory Affairs group. We paid $5.0 million in cash and
assumed
26
liabilities and have agreed to pay an additional cash payment of
$1.0 million over three years if certain performance
measures are met.
Service Revenue
We recognize service revenue from fixed-price
contracts on a
proportional performance basis as services are provided. To
measure performance on a given date, we compare each
contract’s direct cost incurred to such
contract’s
total estimated direct cost through completion. We believe this
is the best indicator of the performance of the contractual
obligations because the costs relate to the amount of labor
incurred to perform the service revenues. For time and materials
contracts, revenue is recognized as hours are incurred,
multiplied by contractual billing rates. Our
contracts often
undergo modifications, which can change the amount of and the
period of time in which to perform services. Our
contracts
provide for such modifications.
Most of our
contracts can be terminated by our clients after a
specified period, typically 30 to 60 days, following notice
by the client. In the case of early termination, these
contracts
typically require payment to us of expenses to wind down a
study, payment to us of fees earned to date, and in some cases,
a termination fee or some portion of the fees or profit that we
could have earned under the
contract if it had not been
terminated early. Based on ethical, regulatory, and health
considerations, this wind-down activity may continue for several
quarters or years.
Reimbursement Revenue and Reimbursable Out-of-Pocket
Costs
We incur out-of-pocket costs, which are reimbursable by our
customers. We include these out-of-pocket costs as reimbursement
revenue and reimbursable out-of-pocket expenses in our
consolidated statement of operations. In addition, we routinely
enter into separate agreements on behalf of our clients with
independent physician investigators, to whom we pay fees, in
connection with clinical trials. These investigator fees are not
reflected in our service revenue, reimbursement revenue,
reimbursable out-of-pocket costs, and/or direct costs, since
such fees are reimbursed by our clients, on a
“pass-through” basis, without risk or reward to us,
and we are not otherwise obligated to either perform the service
or to pay the investigator in the event of default by the
client. Reimbursement costs and investigator fees are not
included in our backlog.
Direct Costs
Direct costs consist of amounts necessary to carry out the
revenue and earnings process, and include direct labor and
related benefit charges and other costs primarily related to the
execution of our
contracts. Direct costs as a percentage of
service revenue fluctuate from one period to another as a result
of changes in labor utilization in the multitude of studies
conducted during any period of time.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses consist of
administration payroll and benefits, marketing expenditures, and
overhead costs such as information technology and facilities
costs. These expenses also include central overhead costs that
are not directly attributable to our operating business and
include certain costs related to insurance, professional fees,
and property.
Depreciation and Amortization
Depreciation represents the depreciation charged on our fixed
assets. The charge is recorded on a straight-line method, based
on estimated useful lives of three to seven years for computer
hardware and software and seven years for furniture and
equipment. Leasehold improvements are depreciated over the
shorter of ten years or the lease term. Amortization expenses
consist of amortization costs recorded on identified
finite-lived intangible assets on a straight-line method over
their estimated useful lives. Goodwill and indefinite-lived
intangible assets were being amortized prior to
January 1,
2002. Pursuant to SFAS No. 142
“Goodwill and
Other Intangible Assets,” we do not amortize goodwill and
indefinite-lived intangible assets.
27
Income Taxes
Because we conduct operations on a global basis, our effective
tax rate has and will continue to depend upon the geographic
distribution of our pre-tax earnings among several statutory
foreign jurisdictions with varying tax rates. Our effective tax
rate can also vary based on changes in the tax rates of
different jurisdictions. Our effective tax rate is also impacted
by either the generation or utilization of net operating loss
carryforwards.
Our foreign
subsidiaries are taxed separately in their
respective jurisdictions. As of
December 31, 2004, we had
cumulative foreign net operating loss carryforwards of
approximately $20.2 million. The carryforward periods for
these losses vary from four years to an indefinite number of
years depending on the jurisdiction. Our ability to offset
future taxable income with the foreign net operating loss
carryforwards may be limited in certain instances, including
changes in ownership. No benefit for these foreign net operating
losses has been recognized for financial statement purposes.
Exchange Rate Fluctuations
The majority of our foreign operations transact in the euro,
pound sterling, or Canadian dollar. As a result, our revenue is
subject to exchange rate fluctuations with respect to these
currencies. We have translated these currencies into
U.S. dollars using the following average exchange rates:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
Three Months | |
| |
|
Year Ended December 31, | |
|
Ended | |
| |
|
| |
|
March 31, | |
| |
|
2002 | |
|
2003 | |
|
2004 | |
|
2005 | |
| |
|
| |
|
| |
|
| |
|
| |
|
U.S. Dollars per:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Euro
|
|
|
0.9463 |
|
|
|
1.1378 |
|
|
|
1.2466 |
|
|
|
1.3085 |
|
| |
Pound Sterling
|
|
|
1.5056 |
|
|
|
1.6431 |
|
|
|
1.8362 |
|
|
|
1.8975 |
|
| |
Canadian Dollar
|
|
|
0.6393 |
|
|
|
0.7181 |
|
|
|
0.7716 |
|
|
|
0.8148 |
|
28
Results of Operations
Many of our current
contracts include clinical trials covering
multiple geographic locations. We utilize the same management
systems and reporting tools to monitor and manage these
activities on the same basis worldwide. For this reason, we
consider our operations to be a single business unit, and we
present our results of operations as a single reportable segment.
The following table summarizes certain statement of operations
data as a percentage of service revenue for the periods shown.
We monitor and measure costs as a percentage of service revenue
rather than total revenue as this is a more meaningful
comparison and better reflects the operations of our business.
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
Three Months | |
| |
|
Year Ended December 31, | |
|
Ended March 31, | |
| |
|
| |
|
| |
| |
|
2002 | |
|
2003 | |
|
2004 | |
|
2004 | |
|
2005 | |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Service revenue
|
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
Direct costs
|
|
|
53.7 |
|
|
|
51.1 |
|
|
|
48.3 |
|
|
|
49.0 |
|
|
|
47.9 |
|
|
Selling, general, and administrative
|
|
|
32.8 |
|
|
|
32.5 |
|
|
|
32.5 |
|
|
|
32.9 |
|
|
|
33.1 |
|
|
Depreciation and amortization
|
|
|
4.0 |
|
|
|
3.6 |
|
|
|
3.5 |
|
|
|
3.5 |
|
|
|
3.8 |
|
|
Management fee
|
|
|
0.5 |
|
|
|
0.3 |
|
|
|
0.3 |
|
|
|
0.3 |
|
|
|
— |
|
|
Option repurchase
|
|
|
— |
|
|
|
— |
|
|
|
1.3 |
|
|
|
5.6 |
|
|
|
— |
|
|
Vested option bonus
|
|
|
— |
|
|
|
— |
|
|
|
0.9 |
|
|
|
2.3 |
|
|
|
— |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations
|
|
|
9.0 |
|
|
|
12.5 |
|
|
|
13.1 |
|
|
|
6.4 |
|
|
|
15.2 |
|
|
Interest expense
|
|
|
(2.4 |
) |
|
|
(2.9 |
) |
|
|
(1.4 |
) |
|
|
(1.2 |
) |
|
|
(0.2 |
) |
|
Interest income
|
|
|
0.1 |
|
|
|
0.1 |
|
|
|
0.1 |
|
|
|
0.1 |
|
|
|
0.3 |
|
|
Other income (expenses), net
|
|
|
(0.4 |
) |
|
|
(1.6 |
) |
|
|
(0.0 |
) |
|
|
0.7 |
|
|
|
(0.0 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
|
6.3 |
|
|
|
8.1 |
|
|
|
11.8 |
|
|
|
5.9 |
|
|
|
15.2 |
|
|
Provision for income taxes
|
|
|
3.1 |
|
|
|
2.8 |
|
|
|
4.3 |
|
|
|
2.4 |
|
|
|
5.8 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
3.2 |
% |
|
|
5.3 |
% |
|
|
7.5 |
% |
|
|
3.5 |
% |
|
|
9.5 |
% |
| |
|
|
|
|
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Service revenue increased by $6.8 million, or 10.1%, from
$66.8 million for the first quarter of 2004 to
$73.6 million for the first quarter of 2005 due to the
expansion of our services to both existing and new clients and a
favorable impact from foreign currency fluctuations of
approximately $1.6 million. On a geographic basis, service
revenue for the first quarter of 2005 was distributed as
follows: North America $50.3 million (68.3%), Europe
$21.4 million (29.1%), and rest of world $1.9 million
(2.6%). For the first quarter of 2004, service revenue was
distributed as follows: North America $46.3 million
(69.2%), Europe $19.1 million (28.6%), and rest of world
$1.5 million (2.2%).
Direct costs increased by $2.5 million, or 7.6%, from
$32.8 million for the first quarter of 2004 to
$35.3 million for the first quarter of 2005 due to
increased personnel needed to support increased project related
activity, from an average of 1,797 for the first quarter of 2004
to an average of 1,925 for the first quarter of 2005 and were
affected by an unfavorable impact from foreign currency
fluctuation of approximately $0.7 million. Direct costs as
a percentage of service revenue decreased from 49.0% for the
first quarter of 2004 to 47.9% for the first quarter of 2005,
due in part to increased work effort and efficiencies by our
staff in closing three large Phase III databases. In
addition, we experienced an approximate $1.1 million
reduction of international partners costs, as we are performing
a greater portion of the work with our staff. International
partner arrangements are relationships with certain regional or
local CROs to perform work on our behalf in geographic areas
where we have not established or have more limited operations.
29
Selling, general, and administrative expenses increased by
$2.4 million, or 10.9%, from $22.0 million for the
first quarter of 2004 to $24.4 million for the first
quarter of 2005 and were affected by an unfavorable impact from
foreign currency fluctuations of approximately
$0.3 million. Selling, general, and administrative expenses
as a percentage of service revenue were 32.9% for the first
quarter of 2004 and 33.1% for the first quarter of 2005,
resulting in part from the impact of the level and timing of
activity related to the implementation of our Sarbanes-Oxley
compliance program.
Depreciation and amortization expense increased by approximately
$0.4 million, or 18.8%, from $2.3 million for the
first quarter of 2004 to $2.8 million for the first quarter
of 2005. This increase is due to continued investment in
facilities and information technology to support our growth.
Depreciation and amortization expense as a percentage of service
revenue was 3.8% for the first quarter of 2004 and 3.5% for the
first quarter of 2005.
Income from operations increased by $6.9 million, or
161.6%, from $4.3 million for the first quarter of 2004 to
$11.2 million for the first quarter of 2005. Income from
operations as a percentage of service revenue increased from
6.4% for the first quarter of 2004 to 15.2% for the first
quarter of 2005. In January 2004, we closed our
$25.0 million tender offer and special dividend/employee
option bonus program. In connection with this program, we
repurchased $3.7 million of options and paid
$2.7 million to employee holders of vested options.
Approximately $5.3 million was expensed related to these
items in the first quarter of 2004. The increase in income from
operations resulted from improved operating leverage across the
company and the 2004 expenses incurred related to the option
repurchase and bonus program.
Interest income, net increased by $0.9 million from expense
of $0.8 million for the first quarter of 2004 to income of
$0.1 million for the first quarter of 2005. This increase
is due to the inflow of cash proceeds from our initial public
offering and extinguishment of debt during the fourth quarter of
2004.
Other expenses, net decreased by $0.5 million from an
income of $0.5 million for the first quarter of 2004 to
$0.0 million for the first quarter of 2005. The decrease is
attributable to a weakening of the U.S. dollar against
other currencies during 2005 as compared to 2004 and represents
the transaction and revaluation impact of foreign exchange.
Our effective tax rate for the first quarter of 2005 was 38.0%
as compared to 40.2% for the same period in 2004. The decrease
in our effective rate was primarily due to the geographic
distribution of pre-tax earnings.
Service revenue increased by $29.6 million, or 11.9%, from
$247.9 million in 2003 to $277.5 million in 2004 due
to the expansion of our services to both existing and new
clients and a favorable impact from foreign currency
fluctuations of approximately $8.7 million. On a geographic
basis, service revenue for 2004 was distributed as follows:
North America $200.4 million (72.2%), Europe
$70.7 million (25.5%), and rest of world $6.4 million
(2.3%). For 2003, service revenue was distributed as follows:
North America $192.0 million (77.5%), Europe
$52.1 million (21.0%), and rest of world $3.8 million
(1.5%). Our European service revenue for 2004 increased due to
our execution of more global trials, the opening of new
locations, and recent acquisitions.
Direct costs increased by $7.6 million, or 6.0%, from
$126.5 million in 2003 to $134.1 million in 2004 due
to increased personnel needed to support increased project
related activity, from an average of 1,796 in 2003 to an average
of 1,892 in 2004. Direct costs as a percentage of service
revenue decreased from 51.0% in 2003 to 48.3% in 2004, due to
the achievement of improved operating efficiencies, as evidenced
by a 9.2% increase in direct labor costs compared to an 11.9%
increase in service revenue. This was achieved as previously
trained employees attained higher efficiency and productivity
levels and as the percentage of our new employees to total
employees declined.
Selling, general, and administrative expenses increased by
$9.5 million, or 11.8%, from $80.6 million in 2003 to
$90.1 million in 2004. Selling, general, and administrative
expenses as a percentage of service revenue was 32.5% in 2003
and 2004. In July 2004, we signed a lease for our new corporate
office and
30
moved from McLean, Virginia, to our new location in Reston,
Virginia, in November 2004. Included in SG&A is
$1.3 million of estimated lease termination charges related
to this relocation. During the second quarter of 2003, we closed
our Cambridge, England office to eliminate excess internal
capacity. We recorded an expense of $2.6 million related to
this action, which is recorded in selling, general and
administrative expenses and consists primarily of lease
termination costs.
Depreciation and amortization expense increased by approximately
$0.7 million, or 7.8%, from $9.0 million in 2003 to
$9.7 million in 2004. Depreciation and amortization expense
as a percentage of service revenue was 3.6% in 2003 and 3.5% in
2004.
Income from operations increased by $5.4 million, or 17.4%,
from $31.0 million in 2003 to $36.4 million in 2004.
Income from operations as a percentage of service revenue
increased from 12.5% in 2003 to 13.1% in 2004. In January 2004,
we closed our $25.0 million tender offer and special
dividend/employee option bonus program. In connection with this
program, we repurchased $3.7 million of options and paid
$2.7 million to employee holders of vested options. Both of
these items were expensed in 2004. The increase in income from
operations resulted from improved operating leverage from
increased utilization across
the company, partially offset by
the $6.5 million aggregate charge incurred in connection
with the option repurchase and bonus program.
Interest expense, net decreased by $3.3 million, or 47.8%,
from $6.9 million in 2003 to $3.6 million in 2004. The
decrease was primarily due to both the lower effective borrowing
rate achieved through the repayment of our subordinated debt
with the proceeds from the amended credit facilities in December
2003 and the lower average outstanding debt balance during 2004
than in the prior year. All outstanding long-term debt was
prepaid in November, 2004, resulting in an expense of
$1.2 million representing the remaining capitalized
deferred financing costs.
Other income (expenses), net decreased by $4.0 million from
an expense of $4.0 million in 2003 to $0.0 million in
2004. The decrease is attributable to a weakening of the
U.S. dollar against other currencies during 2004 as
compared to 2003 and represents the transaction and revaluation
impact of foreign exchange.
Our effective tax rate for 2004 was 36.6% as compared to 34.3%
for the prior year. The increase in our effective rate was
primarily due to the geographic distribution of pre-tax earnings
and the utilization in the prior period of net operating loss
carryforwards in the United Kingdom, Canada, and Switzerland.
Service revenue increased by $71.5 million, or 40.6%, from
$176.4 million in 2002 to $247.9 million in 2003. The
growth in service revenue was due to an increase in the level of
business generated from both existing and new customers. This
increase in revenue was also due to the realization of the full
year of operations resulting from the CroMedica and Staticon
acquisitions in the second quarter of 2002. Additionally, there
was a favorable impact from foreign currency fluctuations of
approximately $9.4 million. On a geographic basis, service
revenue for 2003 was distributed as follows: North America
$192.0 million (77.5%), Europe $52.1 million (21.0%),
and rest of world $3.8 million (1.5%). For 2002, service
revenue was distributed as follows: North America
$145.4 million (82.5%), Europe $29.3 million (16.6%),
and rest of world $1.7 million (0.9%).
Direct costs increased by $31.7 million, or 33.5%, from
$94.8 million in 2002 to $126.5 million in 2003. This
was primarily due to increased personnel needed to support
increased project activity and increased costs from recent
acquisitions. Direct cost headcount increased from an average of
1,421 in 2002 to an average of 1,796 in 2003. Direct costs as a
percentage of service revenue decreased from 53.7% in 2002 to
51.0% in 2003. This decrease was attributable primarily to
improved operating efficiency as demonstrated by direct labor
costs increasing 28.5% while service revenue increased 40.6%.
This resulted from previously trained employees achieving higher
efficiency and productivity levels and a decline in new
employees as a percentage of our total workforce in this period.
31
Selling, general, and administrative expenses increased by
$22.7 million, or 39.2%, from $57.9 million in 2002 to
$80.6 million in 2003. The increase in expenses was
primarily due to additional personnel costs, costs associated
with the acquisitions, and to a $3.0 million increase in
bad debt expense. The increase in bad debt was primarily due to
two customers who ceased operations in fiscal 2003 as well as
uncertainty in the status of a
contract with another customer.
We establish reserves for identified accounts receivable when
facts and circumstances cause us to question the collection of
the receivable. Also included in this increase is a
$2.6 million charge related to the closure of our
Cambridge, England location. Personnel expenses excluded from
our direct cost headcount are included in selling, general, and
administrative cost, and are referred to as selling, general,
and administrative headcount. This headcount increased from an
average of 246 in 2002 to an average of 343 in 2003. Selling,
general, and administrative expenses as a percentage of service
revenue decreased from 32.8% in 2002 to 32.5% in 2003.
Depreciation and amortization expense increased by
$2.0 million, or 28.9%, from $7.0 million in 2002 to
$9.0 million in 2003. This increase is due to continued
investment in facilities and information technology to support
our growth and due to the full-year impact of acquisitions that
closed in 2002.
Income from operations increased by $15.0 million, or
94.6%, from $16.0 million in 2002 to $31.0 million in
2003. This was due to increased levels of business activity,
together with the acquisitions of Staticon and CroMedica. As a
percentage of service revenue, income from operations increased
from 9.0% for 2002 to 12.5% for 2003. This was primarily due to
improved staff and facility utilization and the reduction in
operating expenses of our recently acquired companies.
Interest expense, net increased by $2.8 million, or 67.2%,
from $4.1 million for 2002 to $6.9 million for 2003.
Approximately $1.3 million reflected a charge for the
remaining unamortized debt discount, and approximately
$0.8 million reflected a charge for the remaining
unamortized debt issuance costs, which were triggered by the
repayment of our subordinated debt.
Other income (expenses), net increased $3.3 million, or
458.0%, from $0.7 million in 2002 to $4.0 million in
2003. The increase was primarily due to the transaction losses
recorded during 2003 of $4.1 million as a result of a
weakening of the U.S. dollar against other currencies
during 2003.
Our effective tax rate for 2003 was 34.3% as compared to 49.4%
for the prior year. The decrease in the effective tax rate was
primarily due to the utilization in 2003 of previously
unrecognized net operating loss carryforwards in the United
Kingdom and Canada. Also contributing to the lower effective tax
rate for 2003 was the income tax rate differential on the
earnings of the United Kingdom and Australia.
Variation in Quarterly Operating Results
Although our business is not generally seasonal, we typically
experience a slight decrease in revenue during the fourth
quarter due to holiday vacations and a similar decrease in new
business awards in the first quarter due to our customers’
budgetary cycles and vacations during the year-end holiday
period.
Liquidity and Capital Resources
As of
March 31, 2005, we had approximately
$69.0 million of cash and cash equivalents. Our expected
primary cash needs on both a short and long-term basis are for
capital expenditures, expansion of services, possible
acquisitions, geographic expansion, working capital, and other
general corporate purposes. We have historically funded our
operations and growth, including acquisitions, with cash flow
from operations, borrowings, and issuances of equity securities.
In the first quarter of 2005, net cash used in operating
activities was $19.5 million as compared to net cash
provided by operations of $2.0 million for the same period
during the prior year. The primary driver of the decrease was
the reduced level of invoices generated in the first quarter of
2005 due to the timing of
contract executions, which is the
point in time we invoice for advanced funds, and due to the
timing achievements of significant billing milestones on certain
contracts. The reduced invoice generation led to decreased
advanced billings during the first quarter of 2005 of
$18.0 million compared to an increase in advanced billings
for the first quarter of 2004 of $2.5 million. Cash
collections from accounts receivable
32
were $95.2 million for the first quarter of 2004, as
compared to $77.5 million for the first quarter of 2005. In
addition, adjustments to reconcile net income of
$7.0 million in the first quarter of 2005 to cash generated
from operating activities include an addback of
$2.7 million for depreciation and amortization and usage of
$10.7 million for changes in assets and liabilities. Days
sales outstanding, which includes accounts receivable, unbilled
services and advanced billings, were negative 9 days and
negative 11 days as of
March 31, 2005 and
2004,
respectively.
In 2004, we generated operating cash flow of $71.6 million
as compared to $2.1 million during the prior year. The
primary driver of the difference was the increase in unbilled
services during 2003 of $16.2 million compared to a
decrease in unbilled services in 2004 of $18.5 million.
Cash collections from accounts receivable were
$402.2 million in 2004, as compared to $358.9 million
in 2003. The improvement in cash collections is due to improved
billing and collection procedures. In addition, adjustments to
reconcile net income of $20.7 million to cash generated
from operating activities include addbacks of $9.7 million
for depreciation and amortization and changes of
$16.9 million in assets and liabilities.
On
November 18, 2004, our common stock began trading on The
Nasdaq National Market under the symbol
“PRAI.” Our
initial public offering, including the underwriters’
over-allotment option, consisted of 3.9 million shares of
common stock sold by us and an additional 3.0 million
shares sold by the selling shareholders at an initial offering
price of $19.00 per share. We received from the offering
net proceeds of approximately $67.0 million, after offering
expenses, of which we used $28.7 million to extinguish all
outstanding principal and accrued interest under our then
existing credit facilities. The remaining net proceeds of
approximately $38.3 million are being used for the
execution of our strategy. We received no proceeds from the sale
of common stock by the selling stockholders.
In January 2004, we closed our $25.0 million tender offer
and special dividend/employee option bonus transaction. We
repurchased $0.1 million of shares and $3.7 million of
our outstanding vested stock options, paid a $16.9 million
special dividend to our stockholders, and paid a
$2.7 million special bonus to employee holders of vested
stock options. The remainder of the $25.0 million was used
to pay fees associated with the transaction. The funds for this
transaction were provided by the
December 23, 2003
refinancing of our credit facilities.
In 2003, we generated operating cash flow of $2.1 million
as compared to $28.4 million in 2002, despite an increase
in net income of $7.6 million, or 135%. The change resulted
from higher net income that was more than offset by changes in
working capital. The decrease in cash flow from operations was
primarily due to an $18.5 million increase in accounts
receivable and unbilled services due to increased service
revenue and project activities, partially offset by a
$4.9 million decrease in accounts payable due to our
improved focus on vendor relations and related payment terms.
Net cash provided by investing activities was $22.5 million
for the first quarter of 2005 as compared to net cash used of
$1.5 million for the first quarter of 2004. In December
2004, we purchased approximately $24.5 million of short
term marketable securities. Additional securities were purchased
during the first quarter of 2005, although we sold all our
marketable securities prior to
March 31, 2005. The
remaining net cash amounts used in investing activities were
primarily related to capital expenditures in connection with
ongoing information technology projects. We expect our capital
expenditures to be approximately $12 million to
$13 million for the full year 2005, with the majority of
the spending related to information technology enhancement and
expansion.
Net cash used in investing activities was $32.4 million and
$9.6 million for 2004 and 2003, respectively. In December
2004, we purchased approximately $24.5 million of short
term marketable securities. The remaining net cash amounts used
in investing activities were primarily related to capital
expenditures in connection with ongoing information technology
projects. In 2003, the net cash used for acquisitions of
$2.0 million and capital expenditures of $8.1 million
were partially offset by cash provided by asset disposals of
$0.5 million.
33
Net cash used in investing activities in 2002 was
$24.6 million compared to $6.0 million in 2001. The
increased use of cash in 2002 was due primarily to the
acquisition of CroMedica. Capital expenditures in 2002 were
$7.8 million compared to $6.0 million in 2001.
Net cash provided by financing activities in the first quarter
of 2005 was $0.0 million compared to net cash used of
$18.1 million in the first quarter of 2004. The primary
driver of the difference was that dividends of
$16.9 million were paid in the quarter ending
March 31, 2004.
Net cash used in financing activities in 2004 was
$6.4 million compared to $26.0 million of cash
provided from financing activities in 2003. In 2004, cash of
$67.0 million was provided by our initial public offering.
Additionally, cash was provided by debt issuance of
$5.0 million, stock option and warrant exercises of
$3.4 million and stockholder receivable payments of
$2.2 million. In 2004, cash of $65.3 million was used
to repay debt. Additionally, $16.9 million was paid in
dividends.
Net cash generated from financing activities in 2003 was
$26.0 million. The net cash generated was primarily due to
the amendment and restatement of our credit facilities on
December 23, 2003, which provided a $20.0 million term
loan A and a $40.0 million term loan B. The
proceeds from this amendment process were used to repay
$20.0 million of subordinated debt and $0.6 million of
related prepayment premiums. In addition, $25.0 million was
reserved for the tender process, which closed in January 2004.
We also obtained a $25.0 million revolving line of credit.
Net cash used in financing activities in 2002 was
$14.6 million compared to $0.9 million in 2001. The
activities in 2002 consisted primarily of the repayment of debt
of approximately $25.3 million and proceeds from debt
issuances of approximately $10.8 million. The activities in
2001 consisted primarily of the receipt of financing proceeds in
connection with the leveraged recapitalization of
$95.5 million. This was offset by payments to former
stockholders and repayments of debt of approximately
$96.5 million.
On
December 23, 2004, we entered into a new unsecured
revolving credit facility of $75.0 million led by Wachovia
Bank, N.A. and Wells Fargo Bank, N.A.
The credit facility provides for a $75.0 million revolving
line of credit that terminates on
December 23, 2008. At any
time within three years after
December 23, 2004 and so long
as no event of default is continuing, we have the right, in
consultation with the administrative agent, to request increases
in the aggregate principal amount of the facility in minimum
increments of $5.0 million up to an aggregate increase of
$50.0 million (and which would make the total amount
available under the facility $125.0 million). The revolving
credit facility is available for general corporate purposes
(including working capital expenses, capital expenditures, and
permitted acquisitions), the issuance of letters of credit and
swingline loans for our account, for the refinancing of certain
existing indebtedness, and to pay fees and expenses related to
the facility. All borrowings are subject to the satisfaction of
customary conditions, including absence of a default and
accuracy of representations and warranties. A portion of the
facility is also available for alternative currency loans.
The interest rates applicable to loans under the revolving
credit facility are floating interest rates that, at our option,
equal a base rate or a LIBOR rate plus, in each case, an
applicable margin. The base rate is a fluctuating interest rate
equal to the higher of (a) the prime rate of interest per
annum publicly announced from time to time by Wachovia as its
prime rate, and (b) the overnight federal funds rate plus
0.50%. The LIBOR rate is, with certain exceptions, the rate set
forth on Telerate Page 3750 (or any replacement pages on
that service) as the interbank offering rate for dollar deposits
with maturities comparable to the interest period (1, 2, 3
or 6 months) we have chosen. In addition, we are required
to pay to the lenders under the facility a commitment fee for
unused commitments at a per annum rate that fluctuates depending
on our leverage ratio. Voluntary prepayments of loans and
voluntary reductions in the unused commitments under the
revolving credit facility are permitted in whole or in part, in
minimum amounts and subject to certain other limitations. The
facility is unsecured, but we have granted a negative pledge on
our assets and those of our
subsidiaries that guarantee the
facility for the benefit of the lenders under the facility.
34
The revolving credit facility requires us to comply with certain
financial covenants, including a maximum total leverage ratio, a
minimum fixed charge coverage ratio, and a minimum net worth.
See “Description of Senior Credit Facility.”
To date we have not drawn any amount of indebtedness under our
revolving credit facility.
We expect to continue expanding our operations through internal
growth and strategic acquisitions and investments. We expect
these activities will be funded from existing cash, cash flow
from operations and, if necessary or appropriate, borrowings
under our existing or future credit facilities or issuances of
equity securities. We believe that our existing capital
resources, together with cash flows from operations and our
borrowing capacity under our revolving credit facility, will be
sufficient to meet our working capital and capital expenditure
requirements for at least the next eighteen months. Our sources
of liquidity could be affected by our dependence on a small
number of industries and clients, compliance with regulations,
international risks, and personal injury, environmental or other
material litigation claims.
Contractual Obligations and Commercial Commitments
The following table summarizes our future minimum payments for
all contractual obligations for years subsequent to the year
ended
December 31, 2004:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Payments Due by Period | |
| |
|
| |
| |
|
Less than | |
|
|
|
More than | |
|
|
| |
|
One Year | |
|
1-3 Years | |
|
3-5 Years | |
|
5 Years | |
|
Total | |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(dollars in thousands) | |
|
Long-term debt, including interest payments
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
Service purchase commitments
|
|
|
754 |
|
|
|
1,508 |
|
|
|
— |
|
|
|
— |
|
|
|
2,262 |
|
|
Capital lease, including interest payments
|
|
|
175 |
|
|
|
62 |
|
|
|
2 |
|
|
|
— |
|
|
|
239 |
|
|
Operating leases
|
|
|
17,679 |
|
|
|
27,853 |
|
|
|
21,144 |
|
|
|
43,125 |
|
|
|
109,801 |
|
|
Less: sublease income
|
|
|
(1,287 |
) |
|
|
(843 |
) |
|
|
— |
|
|
|
— |
|
|
|
(2,130 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
17,321 |
|
|
$ |
28,580 |
|
|
$ |
21,146 |
|
|
$ |
43,125 |
|
|
$ |
110,172 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in amounts attributable to operating leases after
five years is due to long-term leases for several of our
facilities. In April 2004, we executed a lease for a new office
in our Lenexa, Kansas location. The operating lease commitment
is $23.5 million over the 15-year term of the lease. In
July 2004, we entered into a lease for a new office in Reston,
Virginia to replace our former offices in McLean, Virginia. The
lease commitment is approximately $5.9 million over the
ten-year term of the lease. There are no contingent cash payment
obligations related to our acquisitions.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are
reasonably likely to have a current or future material effect on
our financial condition, results of operations, liquidity,
capital expenditures, or capital resources.
Critical Accounting Policies and Estimates
In preparing our financial statements in conformity with GAAP,
management is required to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues
and expenses during the reporting period. Our actual results
could differ from those estimates. We believe that the following
are some of the more critical judgment areas in the application
of our accounting policies that affect our financial condition
and results of operations. We have discussed the application of
these critical accounting policies with our audit committee.
35
Revenue Recognition
The majority of our service revenue is recorded from fixed-price
contracts on a proportional performance basis. To measure
performance, we compare direct costs incurred to estimated total
contract direct costs through completion. We believe this is the
best indicator of the performance of the
contract obligations
because the costs relate to the amount of labor hours incurred
to perform the service. Direct costs are primarily comprised of
labor overhead related to the delivery of services. Each month
we accumulate costs on each project and compare them to the
total current estimated costs to determine the proportional
performance. We then multiply the proportion completed by the
contract value to determine the amount of revenue that can be
recognized. Each month we review the total current estimated
costs on each project to determine if these estimates are still
accurate and, if necessary, we adjust the total estimated costs
for each project. During our monthly
contract review process, we
review each
contract’s performance to date, current cost
trends, and circumstances specific to each study. The original
or current cost estimates are reviewed and if necessary the
estimates are adjusted and refined to reflect any changes in the
anticipated performance under the study. In the normal course of
business, we conduct this review each month in all service
delivery locations. As the work progresses, original estimates
might be deemed incorrect due to, among other things, revisions
in the scope of work or patient enrollment rate, and a
contract
modification might be negotiated with the customer to cover
additional costs. If not, we bear the risk of costs exceeding
our original estimates. Management assumes that actual costs
incurred to date under the
contract are a valid basis for
estimating future costs. Should management’s assumption of
future cost trends fluctuate significantly, future margins could
be reduced. In the past, we have had to commit unanticipated
resources to complete projects, resulting in lower margins on
those projects. Should our actual costs exceed our estimates on
fixed price
contracts, future margins could be reduced, absent
our ability to negotiate a
contract modification. We accumulate
information on each project to refine our bidding process.
Historically, the majority of our estimates and assumptions have
been materially correct, but these estimates might not continue
to be accurate in the future.
Allowance for Doubtful Accounts
Included in “Accounts receivable and unbilled services,
net” on our consolidated balance sheets is an allowance for
doubtful accounts. Generally, before we do business with a new
client, we perform a credit check. We also review our accounts
receivable aging on a monthly basis to determine if any
receivables will potentially be uncollectible. The reserve
includes the specific uncollectible accounts and an estimate of
losses based on historical loss experience. After all attempts
to collect a receivable have failed, the receivable is written
off against the allowance. Based on the information available to
us, we believe our allowance for doubtful accounts is adequate
to cover uncollectible balances. However, actual write-offs
might exceed the recorded reserve.
Tax Valuation Allowance
Based on estimates of future taxable profits and losses in
certain foreign tax jurisdictions, we determined that a
valuation allowance was required for specific foreign loss
carryforwards as of
December 31, 2004. If these estimates
prove inaccurate, a change in the valuation allowance, up or
down, could be required in the future.
Our quarterly and annual effective income tax rate could vary
substantially. We operate in several foreign jurisdictions and
in each jurisdiction where we estimate pre-tax income, we must
also estimate the local effective tax rate. In each jurisdiction
where we estimate pre-tax losses, we must evaluate local tax
attributes and the likelihood of recovery for foreign loss
carryforwards, if any. Changes in currency exchange rates and
the factors discussed above result in the consolidated tax rate
being subject to significant variations and adjustments during
interim and annual periods.
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Stock-Based Compensation
We have a stock-based employee compensation plan. We account for
this plan under the recognition and measurement principles of
the intrinsic value method as prescribed by Accounting
Principles Board Opinion No. 25, “Accounting for Stock
Issued to Employees and related Interpretations.” Under the
intrinsic value method, compensation cost is the excess, if any,
of the fair market value of the underlying common stock at the
grant date or other measurement date over the amount an employee
must pay to acquire the stock. We have determined that all
options granted under our plan had an exercise price equal to or
more than the estimated fair market value of the underlying
common stock on the date of grant.
Historically, as a private company the fair market value of our
common stock was determined by our board of directors
contemporaneously with the grant of a stock option. At the time
of option grants and other stock issuances, our board of
directors considered the status of private and public financial
markets, valuations of comparable private and public companies,
the liquidity of our stock, our existing financial resources,
our anticipated capital needs, dilution to common stockholders
from anticipated future financings and a general assessment of
future business risks, as such conditions existed at the time of
the grant. Had different assumptions or criteria been used to
determine the deemed fair value of our common stock, different
amounts of stock-based compensation could have been reported.
Since the commencement of trading of our common stock on
November 18, 2004, the value of our common stock for
purposes of evaluating stock compensation costs is based on the
quoted market prices.
We measure compensation expense for our employee stock-based
compensation in accordance with the intrinsic value method under
Accounting Principles Board Opinion No. 25. Under this
method, when the exercise price of options granted to employees
is less than the fair value of the underlying stock on the grant
date, compensation expense is recognized over the applicable
vesting period. As the exercise price of the stock option has
equaled or exceeded the fair market value of the underlying
common stock at the date of grant, no compensation expense has
been recorded. We have adopted the disclosure-only provisions of
SFAS No. 123, “Accounting for Stock-Based
Compensation,” as amended by SFAS No. 148.
Footnote 1 to our consolidated financial statements
included in this prospectus sets forth the calculation of our
net income had compensation cost been determined based on the
stock’s fair market value at the grant dates for awards
under our stock option plan in accordance with
SFAS No. 123.
In December 2004 the FASB issued revised
SFAS No. 123(R),
“Share-Based Payment.”
SFAS 123(R) requires that a public entity measure and
recognize in the statement of operations the cost of equity
based service awards based on the grant-date fair value of the
award. That cost will be recognized over the period during which
an employee is required to provide service in exchange for the
award or the vesting period. No compensation cost is recognized
for equity instruments for which employees do not render the
requisite service. Adoption of SFAS 123(R) is required for
fiscal years beginning after
June 15, 2005. We are
evaluating the impact of SFAS 123(R), including the
transition alternatives available to us, and believe it will
reduce operating earnings after adoption, but that it will not
impact our financial position or cash flows.
Long-Lived Assets
We review long-lived asset groups for impairment whenever events
or changes in circumstances indicate that the carrying amount of
the asset group might not be recoverable. If indicators of
impairment are present, we would evaluate the carrying value of
property and equipment in relation to estimates of future
undiscounted cash flows. These undiscounted cash flows and fair
values are based on judgments and assumptions.
Goodwill and Indefinite-Lived Intangible Assets
As a result of our acquisitions we have recorded goodwill and
other identifiable finite and indefinite-lived acquired
intangibles. The identification and valuation of these
intangible assets at the time of acquisition require significant
management judgment and estimates.
37
We test goodwill for impairment on at least an annual basis by
comparing the carrying value to the estimated fair value of our
reporting unit. We test indefinite-lived intangible assets,
principally trade names, on at least an annual basis by
comparing the fair value of the trade name to our carrying
value. The measure of goodwill impairment, if any, would include
additional fair market value measurements, as if the reporting
unit was newly acquired. This process is inherently subjective.
The use of alternative estimates and assumptions could increase
or decrease the estimates of fair value and potentially could
result in an impact to our results of operations.
Inflation
Our long-term
contracts, those in excess of one year, generally
include an inflation or cost of living adjustment for the
portion of the services to be performed beyond one year from the
contract date. As a result, we expect that inflation generally
will not have a material adverse effect on our operations or
financial condition.
Potential Liability and Insurance
We obtain contractual indemnification for all of our
contracts.
In addition, we attempt to manage our risk of liability for
personal injury or death to patients from administration of
products under study through measures such as stringent
operating procedures and insurance. We monitor our clinical
trials in compliance with government regulations and guidelines.
We have adopted global standard operating procedures intended to
satisfy regulatory requirements in the United States and in many
foreign countries and serve as a tool for controlling and
enhancing the quality of our clinical trials. We currently
maintain professional liability insurance coverage with limits
we believe are adequate and appropriate. If our insurance
coverage is not adequate to cover actual claims, or if insurance
coverage does not continue to be available on terms acceptable
to us, our business, financial condition, and operating results
could be materially harmed.
Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk
At
March 31, 2005, we had no amounts outstanding under our
revolving credit facility. Future drawings under the facility
will bear interest at various rates. Historically, we have
mitigated our exposure to fluctuations in interest rates by
entering into interest rate hedge agreements.
Foreign Exchange Risk
Since we operate on a global basis, we are exposed to various
foreign currency risks. First, our consolidated financial
statements are denominated in U.S. dollars, but a
significant portion of our revenue is generated in the local
currency of our foreign
subsidiaries. Accordingly, changes in
exchange rates between the applicable foreign currency and the
U.S. dollar will affect the translation of each foreign
subsidiary’s financial results into U.S. dollars for
purposes of reporting consolidated financial results. The
process by which each foreign subsidiary’s financial
results are translated into U.S. dollars is as follows:
income statement accounts are translated at average exchange
rates for the period; balance sheet asset and liability accounts
are translated at end of period exchange rates; and equity
accounts are translated at historical exchange rates.
Translation of the balance sheet in this manner affects the
stockholders’ equity account, referred to as the cumulative
translation adjustment account. This account exists only in the
foreign subsidiary’s U.S. dollar balance sheet and is
necessary to keep the foreign balance sheet stated in
U.S. dollars in balance. To date such cumulative
translation adjustments have not been material to our
consolidated financial position.
In addition, two specific risks arise from the nature of the
contracts we enter into with our customers, which from time to
time are denominated in currencies different than the particular
subsidiary’s local currency. These risks are generally
applicable only to a portion of the
contracts executed by our
foreign
subsidiaries providing clinical services. The first risk
occurs as revenue recognized for services rendered is
38
denominated in a currency different from the currency in which
the subsidiary’s expenses are incurred. As a result, the
subsidiary’s earnings can be affected by fluctuations in
exchange rates.
The second risk results from the passage of time between the
invoicing of customers under these
contracts and the ultimate
collection of customer payments against such invoices. Because
the
contract is denominated in a currency other than the
subsidiary’s local currency, we recognize a receivable at
the time of invoicing for the local currency equivalent of the
foreign currency invoice amount. Changes in exchange rates from
the time the invoice is prepared until payment from the customer
is received will result in our receiving either more or less in
local currency than the local currency equivalent of the invoice
amount at the time the invoice was prepared and the receivable
established. This difference is recognized by us as a foreign
currency transaction gain or loss, as applicable, and is
reported in other expense or income in our consolidated
statements of operations. Historically, fluctuations in exchange
rates from those in effect at the time
contracts were executed
have not had a material effect on our consolidated financial
results.
Foreign Currency Hedges
In the first quarter of 2005, we entered into a number of
foreign currency hedging
contracts to mitigate exposure to
movements between the U.S. dollar and the pound sterling
and the U.S. dollar and the euro. We agreed to purchase a
given amount of pounds sterling and euros at established dates
throughout 2005. These derivatives are accounted for in
accordance with SFAS No. 133,
“Accounting for
Derivative Instruments and Hedging Activities.” We
recognize derivatives as instruments as either assets or
liabilities in the balance sheet and measure them at fair value.
These derivatives are designated as cash flow hedges.
39
BUSINESS
Overview
We are a leading global
contract research organization, or CRO,
with approximately 2,500 employees working from 24 offices
located in North America, Europe, Africa, South America,
Australia, and Asia. CROs assist pharmaceutical and
biotechnology companies in developing and taking drug compounds,
biologics, and drug delivery devices through appropriate
regulatory approval processes. The conduct of clinical trials,
in which a product candidate is tested for safety and efficacy,
forms a major part of the regulatory approval process.
Completing the approval process as efficiently and quickly as
possible is a priority for sponsoring pharmaceutical and
biotechnology companies because they must receive regulatory
approval prior to marketing their products anywhere in the
world. Revenue for CROs is typically generated on a fee for
service basis on either a time and materials or a fixed-price
contract arrangement with the client organization.
We conduct clinical trials globally and are one of a few CROs in
the world with the capability to serve the growing need of
pharmaceutical and biotechnology companies to conduct complex
clinical trials in multiple geographies concurrently. We
incorporated in Delaware in April 2001, with predecessors dating
back to 1976. Our qualified and experienced clinical and
scientific staff has been delivering clinical drug development
services to our customers for over 25 years, and our
service offerings now encompass all points of the clinical drug
development process. We provide our expertise in several
therapeutic areas of strategic interest to our customers,
including oncology, CNS, cardiovascular, and respiratory/allergy
product development.
We perform a broad array of services across the spectrum of
clinical development programs, from the filing of
Investigational New Drug applications, or INDs, and similar
foreign regulatory applications, to the conduct of all phases of
clinical trials, to product registration and post-marketing
studies. Our core global clinical development services include
the following:
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creating drug development and regulatory strategy plans; |
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executing Phase I clinical trials; |
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performing Phase II through IV multi-center,
international clinical trials; |
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developing and analyzing integrated global clinical databases; |
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preparing and submitting regulatory filings around the
world; and |
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managing long-term drug safety programs. |
Since 1999, we have conducted over 2,300 clinical trial programs
for over 295 clients. We have collaborated with nine of the
ten largest pharmaceutical companies and seven of the ten
largest biotechnology companies over the last two years in all
major therapeutic areas. Moreover, we have preferred vendor
relationships with seven of the world’s leading
pharmaceutical and biotechnology companies. These preferred
vendor relationships allow us to be one of a limited number of
CROs that have been pre-qualified by these clients to compete
for their outsourced projects. In 2004, we derived approximately
52% of our service revenue from biotechnology companies, 38%
from large pharmaceutical companies, and 10% from Japanese
pharmaceutical companies. We generated service revenue of
$277.5 million and operating income of $36.4 million
in 2004, representing a compounded annual growth rate since 2000
of 29.3% and 49.2%, respectively.
CRO Industry
Overview
Companies in the global pharmaceutical and biotechnology
industries outsource product development services to CROs in
order to manage the drug development process more efficiently
and cost-effectively
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and to speed time to market. PRA and other CROs provide clinical
drug development services, including protocol design and
management of Phase I through IV clinical trials, data
management, laboratory testing, and statistical analysis. Some
other CROs also provide preclinical services. CROs provide
services that will generate high quality and timely data in
support of applications for regulatory approval of new drugs or
reformulations of existing drugs as well as to support new and
existing marketing claims. To remain competitive, CROs leverage
selected information technologies and procedures to efficiently
capture, manage, and analyze the large streams of data generated
during a clinical trial.
CROs derive substantially all of their revenue from
pharmaceutical and biotechnology companies’ research and
development expenditures, which have increased substantially in
recent years. Specifically, Frost and Sullivan estimates that
research and development expenditures by such companies totaled
$58.5 billion in 2003, an increase from $41.1 billion
in 2000, representing a compounded annual growth rate of 12.5%.
Excluding spending related to administrative functions to
support the research and development process, which are not
typically outsourced to CROs, estimated research and development
expenditures totaled $47.2 billion in 2003, up from
$32.6 billion in 2000, representing a 13.2% compounded
annual growth rate. Of this amount, approximately
$27.4 billion in 2003 was directly related to Phase I
through Phase IV clinical trials. Such spending, which
excludes expenditures related to pre-clinical activities,
increased between 2000 and 2003 at a compounded annual growth
rate of 12.5%, and represents the total amount of research and
development spending that could potentially be outsourced to PRA
or its competitors offering similar services. According to Frost
and Sullivan, in 2003 pharmaceutical and biotechnology companies
outsourced to CROs approximately $8.4 billion, or 30.7% of
their total research and development spending devoted to
Phase I through Phase IV clinical trials, and
outsourcing of such spending is expected to increase to
$18.5 billion by 2010, representing a compounded annual
growth rate of 12.1%. We anticipate that the rate of outsourcing
will increase due to growing acceptance among drug companies of
the benefits of outsourcing and the growing proportion of
research and development spending accounted for by biotechnology
companies, which tend to outsource a larger portion of their
research and development activities to CROs.
Global Drug Approval Process
Discovering and developing new drugs is an expensive and
time-consuming process and is highly regulated and monitored. In
May 2003, The Tufts Center for the Study of Drug Development
estimated that the total cost to develop a new prescription drug
increased from approximately $231 million in 1987 to
approximately $897 million in 2000. In addition, it
typically takes between 10 and 15 years to develop a new
prescription drug and obtain approval to market it in the United
States. Regulatory requirements are a significant driver of the
costs and time involved in drug development, and are a
contributing factor in limiting the number of approved products
that reach the market to approximately one in 250 molecules that
enter the pre-clinical testing process. Specifically, before a
new prescription drug reaches commercialization, it must undergo
extensive clinical testing, and eventually regulatory review, in
order to verify that the drug is safe and efficacious for its
intended use. CROs offer regulatory and scientific support,
clinical trials management and expertise, and infrastructure and
staffing support, providing the flexibility either to supplement
an organization’s in-house research and development
capabilities or to deliver a fully outsourced solution
throughout the product development cycle.
U.S. Approval Process. In the United States,
applications to market new drug products are submitted to and
reviewed by the FDA. The FDA reviews all aspects of the drug
development process, including drug toxicity levels and
efficacy, protocol design, product labeling and manufacturing,
and marketing claims. If and when the FDA has approved a New
Drug Application, or NDA, or, in the case of biologics, a
Biologic License Application, or BLA, the applicant will be
permitted to market and sell the drug. In some instances,
post-approval trials are requested to monitor safety and to
review efficacy issues.
EU Approval Process. In the European Union, there are two
approval processes, the Centralized Procedure and the Mutual
Recognition Procedure. Any application filed under the
Centralized Procedure is made with the European Agency for the
Evaluation of Medicinal Products, or EMEA, for a marketing
authorization that is valid across all EU member states. This
procedure is available to all new or so-called
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“innovative” medicinal products. It is mandatory for
all medicinal products developed by means of certain
biotechnological processes, medicinal products containing a new
active substance for the treatment of acquired immune deficiency
syndrome, cancer, neurodegenerative disorder or diabetes and
certain medicinal products for veterinary use. The marketing
authorization must be renewed after five years on the basis of a
re-evaluation by the EMEA of the risk-benefit assessment.
Under the Mutual Recognition Procedure, the applicant must first
obtain a marketing authorization by one EU member state. The
authorization procedure is governed by that EU member
state’s laws and regulations. After the authorization by a
member state, this member state may serve as the so-called
reference member state for subsequent submissions to other EU
member states. The other concerned member states take into
consideration the assessment of the reference member state and
must decide upon the marketing authorization within
90 days. Each EU member state may either issue objections
to the application, or request additional data. By the 90th day,
all member states must approve or reject the drug. If the drug
is approved, each member state grants the applicant independent
marketing agreements, which must be renewed every five years.
Periodically, the applicant must submit safety reports to the
national health authorities of each member state.
In addition to the Centralized and the Mutual Recognition
Procedures, a single national marketing authorization within the
EU authorization is applicable, if the applicant chooses to
restrict a marketing authorization to one EU Member State
Japan Approval Process. In Japan, applications are filed
with the Pharmaceutical and Medical Devices Evaluation Center,
or PMDEC. An inspection is done in conjunction with a data
reliability survey by a team from the Organization for
Pharmaceutical Safety and Research. Afterwards, the evaluation
process is passed on to the Central Pharmaceuticals Affairs
Council, or CPAC, whose executive committee members issue a
report to the PMDEC. After further evaluation a final report is
distributed to the Ministry of Health, Labor and Welfare, or
MHLW, which makes the final decision on the drug’s outcome.
Once the MHLW has approved the application, the applicant may
market and sell the drug.
Drug Development Cycle
Regardless of the region in which approval is being sought,
before a new clinical product candidate is ready for submission
for approval by regulatory authorities, it must undergo a
rigorous clinical trial process. The clinical trial process must
be conducted in accordance with regulations promulgated by the
FDA or appropriate foreign regulatory body, which require the
drug to be tested and studied in certain ways. Human clinical
trials seek to establish the safety and efficacy of the drug in
humans. In some situations, clients may outsource the entire
clinical program, all phases or a combination of phases, to a
single CRO to gain efficiencies. The clinical trial process
generally consists of the following interrelated phases, which
may overlap:
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Phase I. Phase I trials are conducted in
healthy individuals and usually involve 20 to 80 subjects and
typically range from six to 12 months. These trials are
designed to establish the basic safety, dose tolerance, and
metabolism of the clinical product candidate. If the trial
establishes basic safety and metabolism of the clinical product
candidate, Phase II trials begin. |
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Phase II. Phase II trials are conducted in
patients who have the disorder a molecule is designed to treat,
typically test 100 to 300 patients, and last on average for
12 to 18 months. Phase II trials are typically
designed to identify possible adverse effects and safety risks,
to determine the efficacy of the clinical product candidate, and
to determine dose tolerance. If the molecule appears safe and
effective, Phase III trials begin. |
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Phase III. Phase III trials involve
significantly larger and more diverse populations than
Phase I and II trials and are conducted at multiple sites.
On average, this phase lasts from one to three years. Depending
on the size and complexity, Phase III CRO contracts can
exceed $10 million in some cases. During this phase, the
drug’s safety and effectiveness are further examined and
evaluated. |
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If the drug passes through Phase III, then an NDA is
submitted for approval by the FDA or other appropriate country
regulatory agencies. The NDA includes, among other things, the
clinical trial data generated and analyzed during the clinical
trial process.
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Post-Approval/Phase IV. During the course of the
review process, various regulatory authorities may approve a
drug for marketing and sale, provided that additional clinical
trials be conducted. Usually referred to as post-approval or
Phase IV trials, these trials may either be for submission
of additional data to regulatory authorities or for
non-registration purposes, such as additional marketing
information. These trials are intended to monitor the
drug’s long-term risks and benefits, to analyze different
dosage levels, to evaluate different safety and efficacy
parameters in target populations, or to substantiate marketing
claims. Phase IV trials typically enroll thousands of
patients and last from six to 24 months. |
CRO Industry Trends
We believe that the following factors have contributed, and will
continue to contribute, to the growth of the CRO industry:
Globalization of Drug Development. Given their desire to
maximize speed and global market penetration to achieve higher
potential returns on their research and development
expenditures, pharmaceutical and biotechnology companies are
increasingly pursuing simultaneous regulatory new drug
submissions and approvals in multiple countries, rather than
sequentially, as in the past. However, many drug companies do
not possess the capability or capacity to simultaneously conduct
large-scale clinical trials in more than one country. In
addition, building and maintaining internal global
infrastructures to pursue multiple drug approvals in different
therapeutic categories and locations may not be cost-effective
for many pharmaceutical and biotechnology companies. In response
to the growing demand for global clinical trials, a few CROs
have built a global presence and are able to quickly and
efficiently initiate and conduct global clinical studies, and
then integrate the information generated.
Increased Number of Products Entering Development. We
believe that pharmaceutical and biotechnology companies will
have a burgeoning number of clinical product candidates and
combination therapies entering clinical trials, resulting in an
increased need to quickly determine the most promising ones.
According to the FDA, the number of active commercial INDs has
increased from 3,611 in 1999 to 4,544 in 2003, representing an
increase of over 25%. We believe that this trend will continue
in the future. New research and development in tandem with
genomic and proteomic capabilities will see many of these
clinical product candidates being tested for multiple
indications and in combination with existing treatments. In
response, many pharmaceutical and biotechnology companies are
enlisting the expertise and flexibility of CROs to expedite and
coordinate clinical trials.
Biotechnology Industry Growth. The biotechnology industry
has experienced significant growth over the last few years,
primarily driven by technological innovations, product
development successes, and recent capital raises. According to
Frost and Sullivan, global biotechnology research and
development expenditures grew from $7.0 billion in 2000 to
$13.3 billion in 2003. We believe that this growth trend in
biotechnology research and development expenditures will
continue. Many biotechnology companies generally seek to avoid
the fixed costs of maintaining an internal drug development
infrastructure and lack the resources and clinical development
expertise to effectively coordinate large-scale clinical trials.
As a result, biotechnology companies tend to outsource
significant portions of their research and development spending
and we believe this will continue to drive the growth of the CRO
industry.
Many biotechnology companies have raised substantial funds in
recent years, and we believe biotechnology companies will devote
a large percentage of these funds to drug development.
Biotechnology companies have historically tended to seek a large
pharmaceutical company partner relatively early in the product
development process for additional capital, assistance with
late-stage development, and the selling and marketing of the
product. Increasingly, however, with greater financial
resources, biotechnology companies are better-positioned to
advance their drug candidates further in the development process
before seeking a partner, thus preserving more or all of the
economic returns for themselves.
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Increased Regulatory Scrutiny. Global drug regulators are
requiring greater amounts of clinical trial data to support the
approval of new drugs. In addition, regulatory agencies are
requiring a greater amount of safety and post-approval
information and monitoring of drugs. The greater complexity in
clinical research, regulatory oversight, and the level of
specialization required to conduct tests have contributed to an
increase in the average number of clinical trials required per
new drug, increasing the uncertainty and costs of bringing a new
drug to market and maintaining the marketing authorization. We
believe that global pharmaceutical and biotechnology companies
that hire CROs to conduct or augment their resources for these
complex trials will continue to drive the demand for CRO
services.
Need for Quick, Efficient, and Cost-Effective Drug
Development. CROs have the therapeutic expertise and
manpower to help drug companies improve and potentially shorten
the drug development process by up to six months, thereby
lengthening the product’s marketing life within its patent
exclusivity period. Furthermore, outsourcing eliminates the
pharmaceutical company’s need to invest in information
systems, infrastructure, hire development researchers, or ramp
up operations, thereby avoiding unnecessary fixed costs. Drug
companies are facing pricing pressures due to the increased use
of generic drugs, governmental pressures and greater overall
price competition for branded drugs. As a result, pharmaceutical
companies wish to introduce new drugs as quickly and efficiently
as possible, since new drugs typically generate the highest
return. For example, a blockbuster pharmaceutical product
($1 billion or more in annual revenues) can produce
$2.7 million or more per day in revenues. Since these
products enjoy market exclusivity from the date of patent, not
the date of first sale, accelerating time to market is critical,
as each additional day of sales results in incremental revenue
to the pharmaceutical company.
Our Competitive Strengths
Global Leadership Position. We are a leading clinical
research organization. We have significant global reach with
resources and knowledge that enable us to seamlessly conduct
trials on six continents concurrently. Our global scale enables
us to select locations that produce more cost-effective and
efficient clinical drug development. In addition, our global
platform facilitates access to strategic locations and timely
patient recruitment for complex clinical trials, which tends to
be one of the most significant challenges for our clients during
the clinical trials process. We have grown our business outside
the United States into regions with significant patient
availability for clinical trials, which has contributed to an
increase in the number of global projects, or projects where
services are rendered on two or more continents, awarded to us
from 14 projects in 2001 to 47 in 2004.
Therapeutic Expertise and Scientific Depth. Our breadth
of experience allows us to offer drug development services,
vendor management, and patient recruitment access across a broad
spectrum of therapeutic indications. We have an experienced team
of clinical and scientific experts who work with our clients to
deliver expertise at all points of the clinical drug development
process. We have particularly strong development expertise in
therapeutic areas that are key priorities for research and
development investment among biotechnology and pharmaceutical
companies. In addition, we have significant relationships with
therapeutic experts, key opinion leaders, and proven
investigators to facilitate timely access to patients in the
most important research and development markets worldwide. We
believe that we are a world leader in oncology, CNS,
cardiovascular, and respiratory/allergy product development,
which are all therapeutic areas requiring significant scientific
expertise and which collectively accounted for 72.8% of all
global research and development spending by pharmaceutical and
biotechnology companies in 2003, according to Frost and
Sullivan. We have recently seen increased business regarding
gastrointestinal disorder studies and have made a strategic
decision to expand our services within infectious disease drug
development.
Attractive Customer Base. Our service offerings appeal to
both biotechnology and pharmaceutical companies. We have
collaborated with nine of the ten largest pharmaceutical
companies and seven of the ten largest biotechnology companies
over the last two years in all major therapeutic areas. We have
a particular strength in the expanding biotechnology industry,
which constituted over 52% of our service revenue in 2004.
Advances in proteomics and genomics and access to capital have
driven growth in the biotechnology industry generally. We
believe that biotechnology industry research and development
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spending is growing at a faster rate than research and
development spending by the pharmaceutical industry. We
currently provide services to an active customer base of over
220 clients, and no single project accounted for more than 5% of
service revenue in 2004. We have established preferred vendor
relationships with seven of the world’s leading
pharmaceutical and biotechnology companies, giving us the
ability to compete for a significant portion of the universe of
available global clinical development projects.
Proven and Incentivized Management Team and Workforce. We
are led by our experienced executive management team with an
average tenure of over 11 years with us or our acquired
companies. This team has been responsible for building our
global platform and maintaining strong client relationships,
leading to service revenue of $277.5 million and operating
income of $36.4 million in 2004, representing compounded
annual growth rates of approximately 29.3% and 49.2%,
respectively, since 2000.
We have assembled an experienced and qualified staff.
Approximately 25% of our workforce has at least a master’s
degree. We believe our employees are well-regarded in the drug
development industry for scientific expertise and their
experience managing many complex drug studies, and are therefore
sought out by clients seeking to benefit from our drug
development experience. We are dedicated to strengthening our
workforce by offering comprehensive training and an attractive
work environment, with the goal of being known as the employer
of choice within the CRO industry. We have broad employee
ownership, with over 100 employees owning equity in
the Company.
Our Strategy
We intend to continue building PRA into the best clinical
development organization in the world by expanding our
therapeutic expertise, strengthening our service offerings and
geographic reach, leveraging our global infrastructure, and
pursuing a disciplined acquisition strategy. The key components
of our strategy are to:
Continue to Leverage and Build Our Expertise in Key
Therapeutic Areas. We believe that our extensive therapeutic
expertise is critical to our customers and for the proper design
and management of all clinical phases of drug development. We
intend to continue capitalizing on our market positions in our
existing therapeutic categories. We have established a
therapeutic business development initiative that is focused on
identifying early clinical product candidates in our core
therapeutic competencies. We believe that oncology, CNS,
cardiovascular, and respiratory/allergy, which according to a
report in R&D Directions (October 2003) together
represented approximately 58% of all drug candidates being
developed by pharmaceutical and biotechnology companies, will be
significant drivers of our growth. Furthermore, we plan to
continue to expand our depth of therapeutic expertise in other
attractive therapeutic areas, such as endocrine and
gastrointestinal disorders. We expect these expanded therapeutic
capabilities to enhance our future growth.
Expand the Breadth and Depth of Our Service Offering. We
plan to build upon our expertise in Phase II and
Phase III clinical trials to further grow market share and
geographic reach. We intend to expand our global regulatory and
drug safety capabilities, which are particularly important to
our current and potential pharmaceutical and biotechnology
clients. The recent acquisition of GMG BioBusiness Ltd. and
anticipated closing of the Regulatory/Clinical Consultants, Inc.
transaction will significantly enhance PRA’s regulatory
service offerings, a key early requirement for our biotechnology
clients. In addition, we intend to enhance our existing service
offering in Phase I and Phase IV clinical trials,
which are among the fastest growing segments of the CRO
industry, according to Frost and Sullivan. Strategic initiatives
we are considering include a first-in-man intensive care
Phase I unit and an expansion of our current safety and
medical affairs offerings with the development of patient
registries and expanded post approval monitoring. Over the
longer term, our initiatives may include clinical laboratory and
small run manufacturing services. We expect electronic data
capture, or EDC, capabilities to be of increasing importance to
our customers, and we are actively augmenting our EDC
capabilities to remain at the forefront of this emerging service
area. Finally, we have made a minority investment in Pharma
eMarket, LLC, which does business as Monitor for Hire, providing
experienced monitors directly to pharmaceutical companies. We
are reviewing this line of business as a candidate for expansion.
45
Leverage Our Infrastructure to Improve Operational
Efficiencies. We have made significant investments and
corporate acquisitions over the past eight years to enhance our
global infrastructure and product offerings. Past investments
include recruiting and training qualified professionals,
developing a worldwide network of offices, and building an
integrated information technology platform. We believe that
these investments will enable us to improve patient recruitment,
improve efficiency of global clinical trial data collection, and
speed regulatory submissions for customers, resulting in
improved project margins and overall profits. We plan to
continue to enhance our information technology platform to
maintain our competitiveness and our adaptable and flexible
business support environment. We continue to make additional
investments and staff training commitments in our proprietary
quality management system, called PRA Management System, or
PRAMS, and have obtained International Standards Organization
9001:2000 registration certification. We believe ISO 9001:2000
certification will assist us in obtaining more global projects
and measuring output and customer satisfaction. PRAMS reinforces
Project
Assurance
sm,
our company-wide commitment to consistently achieving customer
requirements every time, at every location.
Augment Our Geographic Reach in Latin America and Asia.
We intend to replicate the success we have achieved in North
America, Europe, and existing Southern Hemisphere locations to
further expand in Latin America and in Asia. We have expanded
into Argentina to complement our existing office in Brazil, and
have recently opened an office in Asia. Both Latin America and
Asia represent significant growth opportunities for us due to
their large population bases and developing clinical scientific
infrastructures. We plan to continue expanding our capabilities
in these regions to bolster our global development service
offerings. We believe this will enhance the attractiveness of
our service offerings to our existing clients and potential new
clients. It also positions us to continue to meet the growing
demand for simultaneous global clinical trial services.
Continue to Pursue a Disciplined Acquisition Strategy. We
have demonstrated skill in identifying, acquiring, and
integrating high quality strategic acquisitions. Since 1997, we
have successfully integrated several acquisitions, including two
purchased out of bankruptcy, which have expanded our geographic
reach and therapeutic capabilities. We have developed a
well-refined integration process to ensure a consistent and
streamlined assimilation of the staff and expertise of the
acquired company. We formulate a detailed integration plan
during the diligence process so that we may promptly migrate the
acquired operations onto our management system and operating
environment to rapidly capture efficiencies and other synergies.
For example, in June 2002 we acquired CroMedica
International Inc., and within 100 days of the closing, the
company was fully integrated and right-sized. We expect to
opportunistically pursue acquisitions that broaden our drug
development platform, geographic reach, and therapeutic
capabilities, which will further differentiate us from our
competition.
Description of Service Offerings
In connection with clinical trials management services, we offer
a broad array of services that encompass the entire spectrum of
clinical development, from filing of INDs and similar regulatory
applications to the conduct of all phases of clinical trials, to
product registrations and post-marketing studies on a global
basis. We provide many back office services to clients as well,
including processing the payments of investigators and patients.
We also collaborate with third-party vendors for services such
as imaging and analytical lab services. Our core services
include:
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Clinical Trials Management Services |
Clinical trials management services encompass the design,
management, and implementation of study protocols, which are the
critical building blocks of product development programs. We
have extensive resources and expertise to design and conduct
studies on a global basis, develop integrated global product
databases, collect and analyze the data, and prepare and submit
regulatory submissions in the United
46
States, Europe, and the rest of the world. A typical full-scale
program or project may involve the following components:
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clinical program review and consultation; |
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protocol and case report form, or CRF, design; |
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feasibility studies for investigator interest and patient
availability; |
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project management; |
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investigator site selection and qualification; |
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investigational site support and clinical monitoring; |
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data management; |
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analysis and reporting; |
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investigator handbook and meetings; |
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medical and scientific publications; and |
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regulatory filings. |
Clinical trials management services, used by our pharmaceutical
and biotechnology customers, may be performed exclusively by us
or in collaboration with the client’s internal staff or
other CROs. With our broad clinical trial management
capabilities, we conduct single site studies (Phase I),
multi-site domestic studies, and global studies on multiple
continents. Through our electronic trial master file, we can
create, collect, store, edit, and retrieve any electronic
document in any of our office locations worldwide, enabling our
global project teams to work together efficiently regardless of
where they are and allowing seamless transfer of work to a more
efficient locale.
We have significant clinical trials experience in the following
therapeutic areas:
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| Therapeutic Areas: |
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Specific Areas of Expertise: |
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Analgesic
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Acute and chronic pain |
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Cardiovascular disease
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Hypertension, angina pectoris, stroke, peripheral arterial
disease |
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Central nervous system
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Alzheimer’s and other dementias, movement disorders,
schizophrenia, depression, epilepsy, chronic pain, anxiety,
obsessive-compulsive disorders, panic disorders, insomnia,
multiple sclerosis |
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Critical care
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ARDS (acute respiratory distress syndrome) |
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Dermatology
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Wound healing, acne, hair loss, psoriasis |
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Gastronenterology
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Duodenal ulcer, gastric ulcer, gastroesophogeal reflux disease,
H.pylori, nonsteroidal anti-inflammatory drug-induced ulcers,
inflammatory bowel disease, irritable bowel disease,
Crohn’s disease |
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Genitourinary
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Incontinence, sexual dysfunction |
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HIV/AIDS
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Primary disease and treatment/prophylaxis of opportunistic
infections |
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Infectious disease
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Pneumonia, sinusitis, chronic bronchitis, childhood and adult
vaccines |
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Metabolic/ Endocrine disease
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Diabetes, growth hormone |
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Oncology
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Pancreatic, colorectal, breast, renal cell, lung, other cancers |
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Ophthalmology
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Macular degeneration, dry eye |
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Respiratory/Allergy/Pulmonary
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Asthma, allergic rhinitis |
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Rheumatology
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Rheumatoid arthritis, osteoarthritis, lupus |
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Urology
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Sexual dysfunction, urinary incontinence, overactive bladder |
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Virology
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Herpes simplex, chronic hepatitis B, chronic hepatitis C,
genital herpes, respiratory syncytial virus, influenza |
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Women’s health
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Osteoporosis, hormone replacement therapy |
47
Global Scientific and Medical Affairs
Our global scientific and medical affairs group provides three
sets of related services: Global Product Development Services,
which focus on the design and implementation of product
development programs; Global Medical and Safety Services, which
deal with safety-related issues arising in the drug development
and marketing processes; and Global Regulatory Affairs, which
assist clients in dealing with regulatory requirements around
the world. These services are almost always provided in concert
with our clinical trials management services.
Global Product Development Services. Our global product
development services team assists our customers with the design
and implementation of entire product development programs. Our
current and potential customers increasingly seek partners who
can provide these capabilities. Our accomplished drug
development group provides both external and internal customers
with opinion-leader level therapeutic expertise in the design
and implementation of high-quality product development programs
and helps clients achieve key development milestones in a
cost-effective manner. Our global product development services
are generally used by emerging biotechnology companies that lack
clinical development infrastructure, Japanese pharmaceutical
companies pursuing registration in Europe and the United States
and larger pharmaceutical companies exploring new therapeutic
areas. Senior scientific, clinical, and marketing experts from
our global product development services team join our project
teams to perform the following services:
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assess pre-clinical and clinical data, products, and programs; |
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analyze markets and competition; |
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prepare clinical and regulatory approval strategy plans; |
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design clinical studies or programs; |
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assist in the preparation of a business plan to obtain funding
and recommend funding sources; |
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identify and form high-level advisory boards; |
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provide high-level consultation on specific scientific and
clinical issues; and |
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provide program planning, management, and oversight from IND
application submission to product registration and launch. |
Global Medical and Safety Services. Our global medical
and safety services group provides complete safety services,
including processing of individual reports on adverse events
from clinical trials and adverse drug reactions for marketed
products, preparation of individual reports for expedited
submission to health authorities, maintenance of global safety
databases, generation of annual safety updates and periodic
safety update reports in Council for International Organizations
of Medical Services II format, preparation of integrated
summaries of safety, design and conduct of
pharmaco-epidemiological studies, and consultation. The group
includes physicians, epidemiologists, pharmacists,
statisticians, clinical programmers, clinical data specialists,
and research nurses with many years of experience in drug safety
management.
Our global medical and safety services capabilities include:
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reporting of serious adverse events in clinical trials; |
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processing and reporting of adverse drug reactions for marketed
products; |
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periodic safety update reports; |
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safety and pharmaco-epidemiological studies; |
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global database access and integrated safety summaries; and |
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consulting and system analysis. |
48
Global Regulatory Affairs. Our global regulatory affairs
group provides skilled interpretation and consultation on the
complex and evolving regulatory requirements affecting drug
development around the world. Though there has been a greater
amount of harmonization of global regulatory requirements, many
countries still have specific requirements and restrictions, and
many regulatory authorities are requesting greater amounts of
information. Our global regulatory affairs staff greatly
enhances our clients’ ability to submit regulatory
documents in a time-efficient manner in multiple locations and
markets. Our global regulatory affairs team, which has been
augmented by the recent acquisitions of GMG BioBusiness Ltd. and
Regulatory/ Clinical Consultants, Inc., provides the following
services:
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guidance on product submission and registration requirements; |
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client updates on legislative changes; |
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expeditious regulatory review; |
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timely clinical trial start-up; and |
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electronic regulatory submissions. |
Regulatory agencies are rapidly moving toward requiring
submissions in an electronic format and are currently requesting
at least partial electronic submissions. Electronic submissions
allow regulatory agencies to rapidly and efficiently search and
navigate through submissions, thus facilitating and potentially
shortening the time of approval. We have substantial experience
with CoreDossier, the industry standard electronic system that
enables the assembly, management, and publication of the complex
documents that comprise the regulatory submission, which we
believe provides us with a strategic advantage.
Although guidelines for electronic submissions, or eCTD
submissions, have not yet been finalized for regulatory agencies
in Europe, the EMEA does accept and strongly encourages eCTD
submissions and Marketing Authorization Applications in addition
to the submission of printed copies.
Our technical publishing group has the regulatory expertise to
provide our clients with electronic regulatory submissions that
are fully compliant with current FDA or other regulatory agency
guidelines. This group oversees the compilation of submission
components, publishes the submission, and reviews the final
product for content and formatting accuracy and consistency.
Clinical Pharmacology Center (Phase I)
Our clinical pharmacology center, which was completely renovated
in the fourth quarter of 2004, is a fully integrated 50-bed
facility in Lenexa, Kansas. We conduct a wide range of
Phase I and early Phase II trials including
first-in-man, rising dose tolerance, metabolic rate, dose
response, bioequivalence, bioavailability, and drug-drug
interaction. We have conducted over 250 studies to date and have
a database of over 30,000 subjects. Our clinical pharmacology
center maintains a dedicated professional staff of PharmDs,
physicians, RNs, LPNs, medical assistants, and paramedics. We
have an independent Institutional Review Board, or IRB, a
Quality Assurance, or QA, group and a dedicated participant
recruiting department that supports the clinical pharmacology
center.
Project Assurance
We have a differentiated approach to service delivery termed
“Project Assurance,” our company-wide commitment to
consistently achieving customer requirements every time, at
every location. Every aspect of our business is dedicated to the
reliability and successful delivery of each customer project and
timetable. The key component of this approach is called the PRA
Management System, or PRAMS, our quality management system.
PRAMS promotes the reliable delivery of services to customers
through a uniform project management methodology which utilizes
standardized global processes that are monitored by a defined
set of performance metrics. In April, 2005 we obtained
International Standards Organization 9001:2000 registration
certification. We believe ISO 9001:2000 certification will
assist us in obtaining more global projects and measuring output
and customer satisfaction.
49
We have made significant investments in information technology
resulting in a platform that facilitates seamless global
communication and project coordination. This single information
technology platform serves our entire organization. This,
combined with our standardized procedures, allows our project
teams across the world to provide our clients with a consistent
approach and results, no matter which team or location performs
the work. In addition, our standardized information technology
platform assists us in rapidly integrating acquisitions. As
technology is an increasingly important selection criterion for
our clients, we have invested in and integrated both proprietary
and commercially-available information technologies that allow
us to expedite and improve our bidding for client projects,
capture and share clinical trials data electronically, and make
electronic regulatory submissions. We continually review the
system development life cycle of every major technology
component of our internal and external business services in an
effort to maintain our efficiencies and competitive advantage.
Examples of these technology investments include:
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Clinical Trial Management System, or CTMS. CTMS is a
company-wide system used to track and report on the information
associated with managing a clinical trial, from initiation
through closeout. The system is based upon Siebel’s
eClinical product, and allows any authorized user to access data
about any clinical trial from anywhere in the world. We believe
that this system is critical to our ability to successfully
conduct global clinical programs. |
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PRA Estimator. PRA Estimator is our proprietary
comprehensive bid development tool which analyzes every customer
specification and request along with therapeutic and patient
recruitment requirements, using a set of complex algorithms to
develop a number of comprehensive bid response scenarios. |
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Electronic Trial Master File, or e-TMF. e-TMF is a
company-wide document management system that enables all
documents to be scanned, indexed, and warehoused electronically.
The system, which is built on a Documentum platform, allows
access to documents by any authorized user in any of our
offices. We believe the benefits of this system include enhanced
global project coordination, work-sharing across locations,
increased document accountability and tracking ability,
increased security of documents, return of all clinical trial
study documents to clients in electronic form, and facilitation
of electronic regulatory submissions. |
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Electronic Regulatory Submissions. Our electronic
regulatory submissions capability is based on CoreDossier, an
industry-accepted software system. This system allows documents
to be created, indexed, and cross-referenced electronically for
ease of editing while in production and for ease of review by
the appropriate regulatory authorities. Electronic submissions
can be used at the IND and the NDA submission stages. |
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PRA Clinical Data Manager® and Oracle Clinical. We
offer two state-of-the-art data management systems which we
believe provide added flexibility and ease of data transfer for
our clients and ultimately timely submissions to the appropriate
regulatory authority. |
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Electronic Data Capture, or EDC. We believe electronic
data capture, which involves direct entry of clinical trials
data by investigational sites, is gaining acceptance by clients
worldwide. EDC permits more rapid data acquisition and locking
of final databases. We believe that many pharmaceutical and
biotechnology companies will use EDC for their trials at some
point in the near future. EDC technology continues to advance
and standards are constantly being upgraded. Therefore, we have
chosen to work with a number of third party providers and client
specifications for electronic data capture in the field. We have
seamless integration software for data transfer to our two
primary data management systems previously mentioned. We have
facilitated EDC for approximately 40 clinical trials at roughly
1,900 investigational sites involving 17,000 patients. |
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Customer Relationship Management, or CRM. This is a
company-wide system based on the system suite from Siebel
designed to manage customer relations. This system allows
customer relationships and contacts to be tracked and shared
worldwide to ensure consistent customer interactions. |
50
Customers and Suppliers
Our customers include international pharmaceutical and
biotechnology companies in the United States, Europe, and Japan.
We have collaborated with nine of the ten largest pharmaceutical
companies and seven of the ten largest biotechnology companies
over the last two years in all major therapeutic areas. We have
established preferred vendor relationships with seven of the
world’s leading pharmaceutical companies. In 2004, we
derived approximately 52% of our service revenue from
biotechnology companies, 38% from large pharmaceutical
companies, and 10% from Japanese pharmaceutical companies. In
2004, two customers each accounted for more than 10% of our
service revenue. While these percentages represent our revenue
generated from each company, both customers consist of multiple
operating groups that conduct business with us. No single
project accounted for more than 5% of our service revenue in
2004.
We utilize a number of suppliers in our business. In 2004, no
individual supplier was paid more than $2.8 million. In
addition, our top 25 suppliers together received payments during
2004 of approximately $28.9 million. We believe that we
will continue to be able to meet our current and future supply
needs.
Sales and Marketing
Our sales process is team-oriented and involves operations and
global scientific and medical affairs teams who contribute their
knowledge to project implementation strategies presented in
customer proposals. We have a dedicated global sales force
consisting of more than 35 individuals. Our sales force also
works closely with the teams to build long-term relationships
with pharmaceutical and biotechnology companies. Our therapeutic
business development group supports the sales effort by
developing robust service offerings in its core therapeutic
areas, including relationships with key clinical opinion
leaders, global investigator networks, and best-in-class
vendors. Members of senior management are actively involved with
every client in order to facilitate resource allocation, project
delivery fulfillment, and scientific regulatory review to ensure
customer retention and to encourage repeat business. We rely
heavily on our past project performance and therapeutic
expertise in winning new business.
Our proposals are bid centrally, either in North America or
Europe, using our most seasoned managers from operations to
spearhead proposal development on a full-time basis. Our
practice of not bidding on projects that we are unprepared to
deliver on schedule has helped us earn a reputation among
pharmaceutical and biotechnology companies for honesty and
integrity. Our approach to proposal development, led by our
seasoned proposal developers and our knowledgeable drug
development experts, allows us to submit value-added proposals
that address customer requirements in a creative and tailored
manner. Proposal teams often conduct research on competing drugs
and feasibility studies among potential investigators to assess
their interest and patient availability for realistic proposals
and presentations. PRA Estimator, our proprietary, comprehensive
bid-development tool, allows for rapid and accurate budget
creation, which forms the initial basis upon which we manage
project budgets subsequent to the award of work. In 2004, we had
$427.4 million in new business awards, which included 47
global
contracts. In 2004, we received and responded to
$1.25 billion in proposal requests.
Competition
The CRO industry consists of a number of small, limited-service
providers, several dozen medium-sized firms, and several
full-service CROs with international capabilities. The industry
continues to experience consolidation and, in recent years, a
group of large, full-service competitors has emerged. This trend
of industry consolidation appears to have created greater
competition for clients and acquisition candidates among the
larger CROs.
We compete primarily with traditional CROs and in-house research
and development departments of pharmaceutical companies. Our
principal traditional CRO competitors are Charles River
Laboratories International, Inc., Covance Inc., ICON plc, Kendle
International Inc., MDS Inc., Omnicare, Inc., PAREXEL
International Corporation, Pharmaceutical Product Development,
Inc., Quintiles Transnational Corp., SFBC International, Inc.,
and UnitedHealth Group Incorporated. The industry has few
barriers to
51
entry. Newer, smaller entities with specialty focuses, such as
those aligned to a specific disease or therapeutic area, compete
aggressively against larger companies for clients. Increased
competition might lead to price and other forms of competition
that could harm our operating results.
CROs compete on the basis of a number of factors, including
reliability, past performance, expertise and experience in
specific therapeutic areas, scope of service offerings,
strengths in various geographic markets, technological
capabilities, ability to manage large-scale clinical trials both
domestically and internationally, and price. Although there can
be no assurance that we will continue to do so, we believe that
we compete favorably in these areas. If in the future we are
unable to effectively compete in these areas, we could lose
business to our competitors which could harm our operating
results.
Despite the recent consolidation, the CRO industry remains
fragmented, with several hundred smaller, limited-service
providers and a small number of full-service companies with
global capabilities. Although there are few barriers to entry
for smaller, limited-service providers, we believe there are
significant barriers to becoming a global provider offering a
broad range of services and products. These barriers include:
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the cost and experience necessary to develop broad therapeutic
expertise; |
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the ability to manage large, complex international clinical
programs; |
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the ability to deliver high-quality services consistently for
large drug development projects; |
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the experience to prepare regulatory submissions throughout the
world; and |
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the infrastructure and knowledge to respond to the global needs
of clients. |
We believe that many clients tend to develop preferred vendor
relationships with full-service CROs, which could have the
effect of excluding other CROs from the bidding process. We may
experience reduced access to certain potential clients due to
these arrangements. In addition, some of our competitors are
able to offer greater pricing flexibility, which could cause us
to lose business to those competitors and could harm our
operating results.
Backlog
Our studies and projects are performed over varying durations,
ranging from several months to several years. We maintain a
contract backlog to track anticipated service revenue from
projects that either have not started, but are anticipated to
begin in the near future, or are in process and have not been
completed. We recognize a new business award in backlog only
when we receive written or electronic correspondence from the
client evidencing a firm commitment. Cancelled
contracts are
removed from backlog. Based upon the foregoing, our backlog at
December 31, 2004 was approximately $448.8 million and
at
March 31, 2005 was approximately $467.2 million. In
2004, cancellations totaled $61.1 million. For the first
quarter of 2005, cancellations totaled $20.7 million.
We believe our backlog as of any date is not necessarily a
meaningful indicator of our future results for a variety of
reasons. First, studies vary in duration. For instance, some
studies that are included in 2004 backlog may be completed in
2005, while others may be completed in later years. Second, the
scope of studies may change, which may either increase or
decrease the amount of backlog. Third, studies included in
backlog may be subject to bonus or penalty payments, although
such studies do not constitute a material portion of our
business. Fourth, studies may be terminated or delayed at any
time by the client or regulatory authorities. Delayed
contracts
remain in our backlog until a determination of whether to
continue, modify or cancel the study has been made.
52
Intellectual Property
We do not own any patent registrations, applications, or
licenses. We maintain and protect trade secrets, know-how and
other proprietary information regarding many of our business
processes and related systems. We also hold various federal
trademark registrations and pending applications, including:
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PRA® (including a design); |
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PRA International®; |
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PRA Clinical Data Manager®; |
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PRA e-TMF®; and |
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Project
Assurancesm
(application pending). |
Government Regulation
In the United States, the FDA governs the conduct of clinical
trials of drug products in human subjects, the form and content
of regulatory applications, including, but not limited to, IND
applications for human clinical testing and the development,
approval, manufacture, safety, labeling, storage, record
keeping, and marketing of drug products. The FDA has similar
authority and similar requirements with respect to the clinical
testing of biological products. In the European Union, similar
laws and regulations apply, which may slightly vary from one
member state to another and are enforced by the EMEA or
respective national member states’ authorities, depending
on the case.
Governmental regulation directly affects our business. Increased
regulation leads to more complex clinical trials and an increase
in potential business for us. Conversely, a relaxation in the
scope of regulatory requirements, such as the introduction of
simplified marketing applications for pharmaceutical and
biological products, could decrease the business opportunities
available to us.
In the United States, we must perform our clinical drug and
biologic services in compliance with applicable laws, rules and
regulations, including the FDA’s good clinical practice, or
GCP, regulations, which govern, among other things, the design,
conduct, performance, monitoring, auditing, recording, analysis,
and reporting of clinical trials. Before a human clinical trial
may begin, the manufacturer or sponsor of the clinical product
candidate must file an IND with the FDA, which contains, among
other things, the results of preclinical tests, manufacturer
information, and other analytical data. A separate submission to
an existing IND must also be made for each successive clinical
trial conducted during product development. Each clinical trial
must be conducted pursuant to, and in accordance with, an
effective IND. In addition, under GCP, each human clinical trial
we conduct is subject to the oversight of an institutional
review board, or IRB, which is an independent committee that has
the regulatory authority to review, approve and monitor a
clinical trial for which the IRB has responsibility. The FDA,
the IRB, or the sponsor may suspend or terminate a clinical
trial at any time on various grounds, including a finding that
the study subjects are being exposed to an unacceptable health
risk. In the European Union, we must perform our clinical drug
services in compliance with essentially similar laws and
regulations.
In order to comply with GCP regulations, we must, among other
things:
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• |
comply with specific requirements governing the selection of
qualified investigators; |
| |
| |
• |
obtain specific written commitments from the investigators; |
| |
| |
• |
obtain IRB review and approval of the clinical trial; |
| |
| |
• |
verify that appropriate patient informed consent is obtained
before the patient participates in a clinical trial; |
| |
| |
• |
ensure adverse drug reactions resulting from the administration
of a drug or biologic during a clinical trial are medically
evaluated and reported in a timely manner; |
| |
| |
• |
monitor the validity and accuracy of data; |
53
|
|
|
| |
• |
verify drug or device accountability; |
| |
| |
• |
instruct investigators and studies staff to maintain records and
reports; and |
| |
| |
• |
permit appropriate governmental authorities access to data for
their review. |
We must also maintain reports in compliance with applicable
regulatory requirements for each study for specified periods for
auditing by the client and by the FDA or similar regulatory
authorities in other parts of the world.
A failure to comply with applicable regulations relating to the
conduct of clinical trials or the preparation of marketing
applications could lead to a variety of sanctions. For example,
violations of the GCP regulations could result, depending on the
nature of the violation and the type of product involved, in the
issuance of a warning letter, suspension or termination of a
clinical study, refusal of the FDA to approve clinical trial or
marketing applications or withdrawal of such applications,
injunction, seizure of investigational products, civil
penalties, criminal prosecutions, or debarment from assisting in
the submission of new drug applications.
We monitor our clinical trials to test for compliance with
applicable laws and regulations in the United States and the
foreign jurisdictions in which we operate. We have adopted
standard operating procedures that are designed to satisfy
regulatory requirements and serve as a mechanism for controlling
and enhancing the quality of our clinical trials. In the United
States, our procedures were developed to ensure compliance with
the FDA’s GCP regulations and associated guidelines. Within
Europe, all work is carried out in accordance with the European
Community Note for Guidance, “Good Clinical Practice for
Trials on Medicinal Products in the European Community.” In
order to facilitate international clinical trials, we have
implemented common standard operating procedures across all of
our regions to assure consistency whenever it is feasible and
appropriate to do so.
The Standards for Privacy of Individually Identifiable Health
Information, or the Privacy Rule, issued under the Health
Insurance Portability and Accountability Act of 1996, or HIPAA,
restrict the use and disclosure of certain protected health
information, or PHI. Under the Privacy Rule, “covered
entities” may not use or disclose PHI without the
authorization of the individual who is the subject of the PHI,
unless such use or disclosure is specifically permitted by the
Privacy Rule or required by law.
We are not a covered entity under the HIPAA Privacy Rule.
However, in connection with our research activities, we do
receive PHI from covered entities subject to HIPAA. In order for
those covered entities to disclose PHI to us, the covered entity
must obtain an authorization meeting Privacy Rule requirements
from the research subject, or make such disclosure pursuant to
an exception to the Privacy Rule’s authorization
requirement. As part of our research activities, we require
covered entities that perform research activities on our behalf
to comply with HIPAA, including the Privacy Rule’s
authorization requirement.
In the European Union, EC Directive 95/46/ EC on the protection
of individuals with regard to the processing of personal data
and on the free movement of such data, or the Directive, is
intended to protect the personal data of individuals by, among
other things, imposing restrictions on the manner in which
personal data can be collected, transferred, processed, and
disclosed and the purposes for which personal data can be used.
National legislation implementing the Directive or dealing with
personal data include provisions which, in certain EU Member
States, are more stringent than the Directive’s mandates
and/or cover areas that do not fall within the scope of the
Directive. While we strive to comply with all privacy laws
potentially applicable to our operations in Europe, we cannot
guarantee that our business complies with all these laws, which
vary in scope and complexity, in the multiple jurisdictions in
which we operate.
We maintain a registration with the Drug Enforcement Agency, or
DEA, that enables us to use controlled substances in connection
with our research services. Controlled substances are those
drugs and drug products that appear on one of five schedules
promulgated and administered by the DEA under the Controlled
Substances Act, or CSA. The CSA governs, among other things, the
distribution, recordkeeping, handling, security, and disposal of
controlled substances. Our DEA license authorizes us to
54
receive, conduct testing on, and distribute controlled
substances in Schedules II through V. A failure to comply
with the DEA’s regulations governing these activities could
lead to a variety of sanctions, including the revocation or the
denial of a renewal of our DEA registration, injunctions, or
civil or criminal penalties.
Employees
As of
December 31, 2004, we had approximately 2,500
employees, of which 58% were in the United States, 30% were in
Europe, 9% were in Canada, and 3% were in Australia, Africa,
South America, and Asia. Approximately 25% of our workforce has
at least a master’s degree. None of our employees is
represented by a labor union. We believe that our employee
relations are satisfactory. We have entered into employment
agreements with each of our named executive officers. See
“Management — Employment Agreements.”
Liability and Insurance
We may be liable to our clients for any failure to conduct their
studies properly according to the agreed-upon protocol and
contract. If we fail to conduct a study properly in accordance
with the agreed-upon procedures, we may have to repeat a study
or a particular portion of the services at our expense,
reimburse the client for the cost of the services and pay
additional damages.
At our Phase I clinic, we study the effects of drugs on
healthy volunteers. In addition, in our clinical business we, on
behalf of our clients,
contract with physicians who render
professional services, including the administration of the
substance being tested, to participants in clinical trials, many
of whom are seriously ill and are at great risk of further
illness or death as a result of factors other than their
participation in a trial. As a result, we could be held liable
for bodily injury, death, pain and suffering, loss of
consortium, or other personal injury claims and medical expenses
arising from a clinical trial. In addition, we sometimes engage
the services of vendors necessary for the conduct of a clinical
trial, such as laboratories or medical diagnostic specialists.
Because these vendors are engaged as subcontractors, we are
responsible for their performance, and may be held liable for
damages if the subcontractors fail to perform in the manner
specified in their
contract.
To reduce our potential liability, informed consent is required
from each volunteer and we obtain indemnity provisions in our
contracts with clients. These indemnities generally do not,
however, protect us against certain of our own actions such as
those involving negligence or misconduct. Our business,
financial condition and operating results could be harmed if we
were required to pay damages or incur defense costs in
connection with a claim that is not indemnified, that is outside
the scope of an indemnity or where the indemnity, although
applicable, is not honored in accordance with its terms.
We maintain errors and omissions professional liability
insurance in amounts we believe to be appropriate. This
insurance provides coverage for vicarious liability due to
negligence of the investigators who
contract with us, as well as
claims by our clients that a clinical trial was compromised due
to an error or omission by us. If our insurance coverage is not
adequate, or if insurance coverage does not continue to be
available on terms acceptable to us, our business, financial
condition, and operating results could be materially harmed.
Environmental Regulation and Liability
We are subject to various laws and regulations relating to the
protection of the environment and human health and safety in all
of the countries in which we do business, including laws and
regulations governing the management and disposal of hazardous
substances and wastes, the cleanup of contaminated sites and the
maintenance of a safe workplace. Our operations include the use,
generation, and disposal of hazardous materials and highly
regulated medical wastes. We may, in the future, incur liability
under environmental statutes and regulations for contamination
of sites we own or operate (including contamination caused by
prior owners or operators of such sites), the off-site disposal
of hazardous substances, and for personal injuries or property
damage arising from exposure to hazardous materials and
55
wastes relating to our operations. We believe that we have been
and are in substantial compliance with all applicable
environmental laws and regulations and that we currently have no
liabilities under such environmental requirements that could
reasonably be expected to materially harm our business, results
of operations, or financial condition.
Properties
We lease a facility for our corporate headquarters in Northern
Virginia, just outside of Washington, D.C. We also lease
other offices in North America, Europe, Africa, South America,
Australia, and Asia. In 2004, our total rental expense for our
facilities and offices was approximately $12.7 million. We
do not own any real estate. We believe that our properties,
taken as a whole, are in good operating condition and are
suitable for our business operations.
Legal Proceedings
We are involved in an arbitration proceeding instituted in
August 2003 against Cell Therapeutics, Inc. (formerly
Novuspharma S.p.A.) before the International Chamber of
Commerce, International Court of Arbitration. This proceeding
relates to the performance of clinical trial services under an
agreement with Cell Therapeutics. We are seeking payment of
approximately $0.7 million for unpaid services and
expenses. Cell Therapeutics has counterclaimed, claiming
vexatious litigation and seeking $3.8 million for refunds
of prior payments, $4.6 million for lost investments,
approximately $20.3 million for expenses incurred, and
unspecified damages for loss of commercial reputation and
profits. We believe these counterclaims are without merit and
are vigorously contesting them. In July 2004, the International
Court of Arbitration conducted a hearing on this matter in
Geneva, Switzerland, and a ruling is expected in 2005.
We are also currently involved, as we are from time to time, in
legal proceedings that arise in the ordinary course of our
business. We believe that we have adequately reserved for these
liabilities and that there is no other litigation pending that
could materially harm our results of operations and financial
condition.
56
MANAGEMENT
Directors and Executive Officers
The following table sets forth information concerning our
directors and executive officers:
| |
|
|
|
|
|
|
| Name |
|
Age | |
|
Position |
| |
|
| |
|
|
|
Patrick K. Donnelly
|
|
|
47 |
|
|
President, Chief Executive Officer, and Director (term expiring
in 2005) |
|
David W. Dockhorn
|
|
|
44 |
|
|
Executive Vice President of Global Clinical Operations |
|
Erich Mohr
|
|
|
50 |
|
|
Executive Vice President and Chief Scientific Officer |
|
James C. Powers
|
|
|
53 |
|
|
Executive Vice President of Worldwide Business Development and
Secretary |
|
J. Matthew Bond
|
|
|
44 |
|
|
Senior Vice President, Chief Financial Officer, Assistant
Treasurer, and Assistant Secretary |
|
Ken Newport
|
|
|
39 |
|
|
Senior Vice President of Worldwide Business Development |
|
Monika Pietrek
|
|
|
48 |
|
|
Senior Vice President of Global Medical and Safety Services |
|
Bruce A. Teplitzky
|
|
|
49 |
|
|
Senior Vice President of Strategic Business Development |
|
William M. (Bucky) Walsh, III
|
|
|
46 |
|
|
Senior Vice President of Business Services and Strategic Programs |
|
Jean-Pierre L. Conte
|
|
|
41 |
|
|
Chairman (term expiring in 2006) |
|
Melvin D. Booth
|
|
|
60 |
|
|
Director (term expiring in 2007) |
|
Robert E. Conway
|
|
|
51 |
|
|
Director (term expiring in 2007) |
|
Armin Kessler
|
|
|
67 |
|
|
Director (term expiring in 2006) |
|
Robert J. Weltman
|
|
|
40 |
|
|
Director (term expiring in 2005) |
|
|
|
Patrick K. Donnelly, President, Chief Executive Officer, and
Director |
Patrick K. Donnelly joined us in 1994, serving first as an
outside board member and then as executive vice president and
chief financial officer in 1996. In 2001, Mr. Donnelly was
named PRA’s president and chief operating officer, and
subsequently, chief executive officer in 2002. Before joining
PRA, Mr. Donnelly was president of Virginia Capital L.P.
and Vedcorp, LLC, two affiliated venture capital firms located
in Richmond, Virginia. Mr. Donnelly also spent eight years
with BancBoston Capital. Mr. Donnelly received his M.B.A.
from Pennsylvania State University in 1984 and received his B.A.
from the University of Missouri in 1980.
|
|
|
David W. Dockhorn, Ph.D., Executive Vice President of
Global Clinical Operations |
David W. Dockhorn, Ph.D., was named executive vice
president of global clinical operations in 2003. He joined PRA
in 1997 as the vice president of operations and regional
director of the Lenexa, Kansas operations and in 2001 was named
senior vice president of clinical trials services of North
American clinical operations for PRA. Prior to that, he served
as senior vice president for the Lenexa, Kansas regional office
and San Diego, California operations. Previously, he worked
for International Medical Technical Consultants, Inc., or IMTCI,
a CRO which was acquired by PRA in 1997. Dr. Dockhorn
received his Ph.D. in neuroscience from Texas Tech University.
|
|
|
Erich Mohr, Ph.D., Executive Vice President and Chief
Scientific Officer |
Erich Mohr, Ph.D., RPsych, joined PRA in 2002 as executive
vice president and chief scientific officer with the acquisition
of CroMedica International Inc. Dr. Mohr co-founded
CroMedica in 1995, and served as chief executive officer at the
time of the acquisition. Dr. Mohr was the scientific
director of the Institute of Mental Health Research, and
previously the associate director of research for the Royal
57
Ottawa Hospital. Dr. Mohr earned his Ph.D. in
neuropsychology in 1982 and M.S. in neuropsychology in 1980,
both from the University of Victoria, British Columbia, Canada.
Also in British Columbia, Canada, Dr. Mohr became certified
as a registered psychologist, with a specialization in
neuropsychology. In 1977, Dr. Mohr received a
bachelor’s degree in psychology and in 1976 he received a
B.S. in chemistry/biology, both from the University of the
Pacific.
|
|
|
James C. Powers, Executive Vice President of Worldwide
Business Development and Secretary |
James C. Powers is executive vice president of worldwide
business development and secretary of PRA. Mr. Powers
joined PRA in 1988 as vice president and general manager. He
became president of North American operations in 1992 and was
named executive vice president of worldwide business development
in 1996. Prior to joining us, Mr. Powers was vice president
at University Technology Corporation from 1985 to 1988. From
1973 to 1985, Mr. Powers worked at Clairol, Inc.
Mr. Powers received a B.S. in Administration and Management
Science from Carnegie Mellon University in 1973.
|
|
|
J. Matthew Bond, Senior Vice President, Chief Financial
Officer, Assistant Treasurer, and Assistant Secretary |
J. Matthew Bond joined PRA as vice president-finance and
accounting in 2001, and was appointed senior vice president and
chief financial officer of PRA in 2002. Before joining PRA,
Mr. Bond worked as vice president for a division of
Marriott International, Inc. since 1997. He also spent
11 years with a major public accounting firm. Mr. Bond
is a Certified Public Accountant and holds a B.S. in business
from Wake Forest University. He is a board member of Concept
Interiors, Inc.
|
|
|
Ken Newport, Senior Vice President of Worldwide Business
Development |
Ken Newport joined PRA in 2002 as senior vice president of
business development, prior to which he was president and
co-founder of CroMedica. Mr. Newport established an
accounting firm in 1986 and practiced as a Chartered Accountant
until 1996. Mr. Newport is a Chartered Accountant who holds
a Masters of Accounting degree from the University of Waterloo.
Mr. Newport is a board member of Zelos Therapeutics Inc.
and the Ottawa Life Sciences Council.
|
|
|
Monika Pietrek, M.D., Ph.D., Senior Vice President
of Global Medical and Safety Services |
Monika Pietrek, M.D., Ph.D., joined PRA in 1996 as the
director of safety management services and in 2004 was named
senior vice president of global medical and safety services.
Since 1999, she served as vice president for the Mannheim,
Germany operations. Dr. Pietrek received her M.D. and Ph.D.
from University of Frankfurt, Germany and her M.Sc. in
epidemiology from the London School for Hygiene &
Tropical Medicine, London, United Kingdom.
|
|
|
Bruce A. Teplitzky, Senior Vice President of Strategic
Business Development |
Bruce A. Teplitzky was named senior vice president of strategic
business development in 2003. He joined PRA in early 1996 as
vice president of operations and regional director. In 2000, he
was promoted to senior vice president of clinical operations. In
2002, he became senior vice president of global business
development. Prior to joining PRA, Mr. Teplitzky worked for
Stuart Pharmaceuticals (now AstraZeneca), and at Corning
Besselaar. Mr. Teplitzky earned his M.M.S. in clinical
microbiology at the Emory University School of Medicine. He
received his B.S. from Emory University in biologic sciences.
|
|
|
William M. (Bucky) Walsh, III, Senior Vice President of
Business Services and Strategic Programs |
William M. (Bucky) Walsh, III, joined PRA in 1985, and was
named senior vice president of business services in 2002.
Mr. Walsh has been with PRA for more than 19 years,
and has held numerous positions, including program analyst,
director of systems and information technology, and vice
president of systems management. While at PRA in 1991,
Mr. Walsh earned an M.B.A. from James Madison University.
In 1980, Mr. Walsh graduated with a B.A. from the
University of Virginia.
58
|
|
|
Jean-Pierre L. Conte, Chairman |
Jean-Pierre L. Conte is currently chairman, managing director,
and limited partner of Genstar Capital, L.P., the manager of
Genstar Capital Partners III, L.P., a private equity
limited partnership. Mr. Conte joined Genstar in 1995.
Prior to joining Genstar, Mr. Conte was a principal for six
years at the NTC Group, Inc., a private equity investment firm.
He has served as a director, chairman of the board, and a member
of the compensation committee of PRA since 2001. He has also
served as a director and member of the compensation committee of
BioSource International, Inc. since 2000, and interim chairman,
then chairman, of BioSource’s board of directors since
2001. Mr. Conte has also served as a director and as the
chairman of the compensation committee of North American Energy
Partners, Inc. since 2003, as chairman of the board of directors
of Altra Industrial Motion, Inc. since December 2004, and as a
director of Propex Fabrics, Inc. since December 2004.
Mr. Conte has also served as a member of the Management
Committee of AP Enterprises Holdings, LLC since May 2004.
Mr. Conte holds an M.B.A. from Harvard University and a
B.A. from Colgate University.
|
|
|
Melvin D. Booth, Director |
Melvin D. Booth is currently a part-time employee of MedImmune
Ventures, Inc. Mr. Booth was the president and chief
operating officer of MedImmune, Inc. from October 1998 through
December 2003. Prior to joining MedImmune, Inc., he was
president, chief operating officer, and a member of the board of
directors of Human Genome Sciences, Inc. Mr. Booth is
currently a board member of NovaScreen Biosciences Corporation,
Focus Technologies, Inc., Ventria Bioscience, Prestwick
Pharmaceuticals, Inc. and Millipore Corporation. Mr. Booth
graduated with honors and holds an honorary Doctor of Science
degree from Northwest Missouri State University. He is a
Certified Public Accountant.
|
|
|
Robert E. Conway, Director |
Robert E. Conway is currently the chief executive officer of
Array BioPharma Inc., which he joined in November 1999. Prior to
joining Array BioPharma, Mr. Conway was the chief operating
officer and executive vice president of the Clinical Trials
Division of Hill Top Research, Inc., which he joined in 1996.
Mr. Conway serves on the boards of directors of Array
BioPharma and DEMCO, Inc. Mr. Conway received a B.S. in
accounting from Marquette University and an M.B.A. from the
University of Cincinnati, and is a Certified Public Accountant.
Armin Kessler is an experienced global pharmaceutical and
biotech industry executive. Prior to his retirement in 1995,
Mr. Kessler held many executive positions at
Hoffman-LaRoche AG, including chief operating officer and head
of the pharmaceutical division. Mr. Kessler has also held
executive positions at Sandoz, and has been a member of the
board of directors of Genentech and Syntex, as well as the
president of the European Federation of Pharmaceutical Industry
Associations. He became a director of PRA in January 2005 and
currently is also a director of Spectrum Pharmaceuticals,
Gen-Probe Incorporated, Actelion, and The Medicines Company.
Mr. Kessler received a B.S. from the University of
Pretoria, South Africa, a B.S. from the University of Cape Town,
a J.D. from Seton Hall University, and an Honorary Doctorate of
Business Administration from University of Pretoria, South
Africa. Mr. Kessler qualified as a U.S. patent
attorney in 1972. Mr. Kessler currently serves on both our
compensation and nominating and corporate governance committees.
|
|
|
Robert J. Weltman, Director |
Robert J. Weltman is currently a managing director of Genstar
Capital, L.P., the manager of Genstar Capital Partners III,
L.P., a private equity limited partnership. Mr. Weltman
joined Genstar in 1995. Prior to joining Genstar, from 1993 to
1995, he was an associate with Robertson, Stephens &
Company, an investment banking firm. From 1991 to 1993, he
worked for Salomon Brothers Inc. as a financial analyst. He has
served as a director of PRA since 2001 and of BioSource
International, Inc. since 2000.
59
Mr. Weltman has also served as a member of the Management
Committee of AP Enterprises Holdings, LLC since May 2004, and as
a director of Woods Equipment Company, LLC since June 2004, and
AXIA Health Management, LLC since December 2004.
Mr. Weltman holds an A.B. in chemistry from Princeton
University.
Board of Directors
The size of our board of directors has been fixed at seven
members who are divided into three classes, with each director
serving a three-year term and one class being elected at each
annual stockholder’s meeting. At each annual meeting, our
stockholders will elect the successors to our directors. Our
executive officers and key employees serve at the discretion of
our board of directors. Directors may be removed with or without
cause by the affirmative vote of the holders of a majority of
the common stock. Our committees are comprised of a majority of
independent directors as required under the applicable rules of
The Nasdaq Stock Market. We expect that by November 2005 our
board of directors will be comprised of a majority of
independent directors and our audit, compensation, and
nominating and corporate governance committees will be comprised
entirely of independent directors.
Committees of Our Board of Directors
Our board of directors directs the management of our business
and affairs, as provided by Delaware law, and conducts its
business through meetings of the board of directors and three
standing committees: the audit committee, the compensation
committee, and the nominating and corporate governance
committee. In addition, from time to time, special committees
may be established under the direction of the board of directors
when necessary to address specific issues. The composition of
the board committees will comply, when required, with the
applicable rules of The Nasdaq Stock Market and applicable law.
Audit Committee. Our audit committee is directly
responsible for, among other things, the appointment,
compensation, retention, and oversight of our independent
registered public accounting firm. The oversight includes
reviewing with the independent registered public accounting firm
the plans and results of the audit engagement, approving any
additional professional services provided by the independent
registered public accounting firm, and reviewing the
independence of the independent registered public accounting
firm. The committee also reviews with the independent registered
public accounting firm and relevant financial management the
adequacy and effectiveness of the accounting and financial
reporting controls, and discusses any significant matters
regarding internal control over financial reporting that come to
its attention during the completion of the audit. Our audit
committee currently comprises Mr. Booth, who is the chair
of the committee, Mr. Conway, and Mr. Weltman. Our
board of directors has determined that Mr. Booth and
Mr. Conway are independent directors within the meaning of
applicable Nasdaq listing requirements. Our audit committee has
determined that Mr. Booth is an audit committee financial
expert as that term is defined under the Securities Exchange Act
of 1934.
Compensation Committee. The compensation committee is
responsible for determining compensation for our executive
officers and administering our stock option plans and other
compensation programs. The compensation committee is also
responsible for establishing, periodically re-evaluating, and,
where appropriate, adjusting and administering policies
concerning compensation of our management. Our compensation
committee currently comprises Mr. Conway, who is the chair
of the committee, Mr. Kessler, and Mr. Conte.
Nominating and Corporate Governance Committee. Our
nominating and corporate governance committee is responsible for
assisting the board of directors in selecting new directors,
evaluating the overall effectiveness of the board of directors,
and reviewing developments in corporate governance compliance.
Our nominating and corporate governance committee currently
comprises Mr. Conte, who is the chair of the committee,
Mr. Kessler, and Mr. Conway. The board has determined
that Mr. Kessler and Mr. Conway are independent
directors within the meaning of applicable Nasdaq listing
requirements.
60
Director Compensation
Our non-employee directors who are not affiliated with Genstar
receive a $35,000 annual retainer and a $1,500 fixed fee for
attending each board and committee meeting ($750 for attending
telephonically). Our audit committee chair receives an
additional $15,000 per year, and other committee chairs
receive an additional $10,000 per year. Non-employee
directors who are not affiliated with Genstar receive an initial
award of options exercisable for 40,000 shares of common
stock and an additional award of options exercisable for
10,000 shares after each year of service. We also reimburse
our directors for their reasonable expenses incurred in
connection with attending board and committee meetings.
Mr. Donnelly is employed by us and is not separately
compensated for his service as a director.
Compensation Committee Interlocks and Insider
Participation
None of our executive officers serves as a director or member of
the board of directors or compensation committee of any entity
that has one or more executive officers serving as a director or
member of our compensation committee.
Executive Compensation
The following table sets forth all compensation paid to our
chief executive officer and each of the four other most highly
compensated executive officers whose salary and bonuses exceeded
$100,000 during the year ended
December 31, 2004 and all
compensation to such persons during the year ended
December 31, 2003. We refer to these executives as our
named executive officers.
Summary Compensation Table
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
Long Term | |
| |
|
|
|
|
|
Compensation | |
| |
|
|
|
Annual Compensation | |
|
Awards | |
| |
|
|
|
| |
|
| |
| |
|
|
|
|
|
Securities | |
| |
|
|
|
|
|
Other Annual | |
|
Underlying | |
| |
|
|
|
Salary |
|
Bonus |
|
Compensation | |
|
Options | |
| Name and Principal Position |
|
Year |
|
($) |
|
($) |
|
($)(1) | |
|
(#) | |
| |
|
|
|
|
|
|
|
| |
|
| |
|
Patrick K. Donnelly
|
|
2004 |
|
315,000 |
|
217,757 |
|
|
472,261 |
(2) |
|
|
90,000 |
|
| |
President, Chief Executive Officer, |
|
2003 |
|
243,333 |
|
181,250 |
|
|
16,893 |
(3) |
|
|
— |
|
| |
and Director |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David W. Dockhorn
|
|
2004 |
|
222,500 |
|
84,870 |
|
|
195,967 |
(4) |
|
|
50,000 |
|
| |
Executive Vice President of Global |
|
2003 |
|
204,375 |
|
75,000 |
|
|
20,173 |
(5) |
|
|
— |
|
| |
Clinical Operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erich Mohr(6)
|
|
2004 |
|
284,266 |
|
109,776 |
|
|
78,442 |
(7) |
|
|
50,000 |
|
| |
Executive Vice President and Chief |
|
2003 |
|
240,539 |
|
116,697 |
|
|
16,911 |
(8) |
|
|
— |
|
| |
Scientific Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
James C. Powers
|
|
2004 |
|
199,375 |
|
128,421 |
|
|
283,345 |
(9) |
|
|
50,000 |
|
| |
Executive Vice President of |
|
2003 |
|
194,458 |
|
75,000 |
|
|
32,348 |
(10) |
|
|
— |
|
| |
Worldwide Business Development and Secretary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bruce A. Teplitzky
|
|
2004 |
|
194,375 |
|
178,673 |
|
|
172,227 |
(11) |
|
|
25,000 |
|
| |
Senior Vice President of Strategic |
|
2003 |
|
189,166 |
|
56,250 |
|
|
26,348 |
(12) |
|
|
— |
|
| |
Business Development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
(1) |
Includes payments, in the amounts specified below, made to all
of our employee option holders at the rate of $0.94 per
option in connection with a tender offer transaction in January
2004. We refer to these as option bonus payments. |
|
| |
| |
(2) |
Represents option bonus payments of $445,554, car allowance of
$10,800, club allowance of $1,200, contributions by PRA to
health insurance of $9,022, contributions by PRA to life
insurance of $48, contributions by PRA to long-term disability
of $252, contributions by PRA to short-term disability of $384,
and contributions by PRA to 401(k) of $5,001. |
|
61
|
|
|
|
| |
(3) |
Represents car allowance of $10,800, club allowance of $1,200,
contributions by PRA to health insurance of $1,780,
contributions by PRA to life insurance of $66, contributions by
PRA to long-term disability of $270, contributions by PRA to
short-term disability of $408, and contributions by PRA to
401(k) of $2,369. |
|
| |
| |
(4) |
Represents option bonus payments of $177,190, car allowance of
$10,800, club allowance of $1,200, contributions by PRA to
health insurance of $6,093, contributions by PRA to life
insurance of $48, contributions by PRA to long-term disability
of $252, and contributions by PRA to short-term disability of
$384. |
|
| |
| |
(5) |
Represents car allowance of $10,800, club allowance of $1,200,
contributions by PRA to health insurance of $6,363,
contributions by PRA to life insurance of $66, contributions by
PRA to long-term disability of $270, contributions by PRA to
short-term disability of $408, and contributions by PRA to
401(k) of $1,066. |
|
| |
| |
(6) |
Erich Mohr is compensated in Canadian dollars. All amounts
related to his compensation have been converted from Canadian
dollars to U.S. dollars using the average exchange rate for
fiscal year 2004 of Cdn $1.3015 per US$1.00 and
Cdn $1.3925 for fiscal year 2003. |
|
| |
| |
(7) |
Represents option bonus payments of $60,320, car allowance of
$9,797, fitness allowance of $1,484, and contributions by PRA to
life insurance of $6,841. |
|
| |
| |
(8) |
Represents car allowance of $9,155, fitness allowance of $1,383,
and contributions by PRA to life insurance of $6,373. |
|
| |
| |
(9) |
Represents option bonus payments of $248,820, car allowance of
$10,800, club allowance of $1,200, contributions by PRA to
health insurance of $15,341, contributions by PRA to life
insurance of $48, contributions by PRA to long-term disability
of $252, contributions by PRA to short-term disability of $384,
and contributions by PRA to 401(k) of $6,500. |
|
|
|
|
|
| |
(10) |
Represents car allowance of $10,800, club allowance of $1,200,
contributions by PRA to health insurance of $13,604,
contributions by PRA to life insurance of $66, contributions by
PRA to long-term disability of $270, contributions by PRA to
short-term disability of $408, and contributions by PRA to
401(k) of $6,000. |
|
| |
| |
(11) |
Represents option bonus payments of $144,202, car allowance of
$10,800, club allowance of $1,200, contributions by PRA to
health insurance of $15,341, contributions by PRA to life
insurance of $48, contributions by PRA to long-term disability
of $252, and contributions by PRA to short-term disability of
$384. |
|
| |
| |
(12) |
Represents car allowance of $10,800, club allowance of $1,200,
contributions by PRA to health insurance of $13,604,
contributions by PRA to life insurance of $66, contributions by
PRA to long-term disability of $270, and contributions by PRA to
short-term disability of $408. |
|
Stock Option Grants in 2004
The following table reflects the stock options granted during
the past fiscal year to the named executive officers pursuant to
our 2004 Incentive Award Plan. No stock appreciation rights were
granted to the named executive officers during 2004. Unless
otherwise noted, all options granted during the past fiscal year
expire seven years from the date of grant. If the
optionee’s employment is terminated for cause, any vested
or unvested portion of the option will terminate. Under the
option agreement, “cause” is defined as the
optionee’s failure to perform duties; material harm to PRA;
conviction of a felony or crime involving moral turpitude, fraud
or misrepresentation; or misappropriation or embezzlement of PRA
funds or assets. In addition, if the optionee’s employment
is terminated for any reason other than death, disability or
cause, the unvested portion of the option will terminate and the
optionee will have thirty days to exercise any vested portion of
the option. Upon the optionee’s death or disability, a pro
rata portion of the option will vest, based on the amount that
would vest on the next anniversary of the grant date, and be
exercisable by the optionee’s beneficiary or estate for
eighteen months or, if earlier, until the seventh anniversary of
the grant date. For a specified noncompetition period, if a
named competitor engages or employs the optionee
62
for services substantially similar to services the optionee
performed for us, the optionee will forfeit all vested and
unvested rights under the option agreement. The noncompetition
period is defined as the employment period plus a specified
post-employment period depending on the optionee’s status
at the grant date. Currently, the post-employment period is six
months for vice presidents, nine months for senior vice
presidents, and twelve months for board members and executive
officers. If the optionee violates the noncompetition provision,
we have the right to repurchase shares the optionee acquired on
exercise or to require reimbursement of any proceeds the
optionee received from any sale or other disposition of such
shares. The optionee also must return any dividends or other
distributions paid on such shares.
OPTION GRANTS IN 2004
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Individual Grants |
|
Potential Realizable | |
| |
|
|
|
Value at Assumed | |
| |
|
Number of | |
|
Percent of | |
|
|
|
Annual Rates of Stock | |
| |
|
Securities | |
|
Total Options | |
|
|
|
Price Appreciation for | |
| |
|
Underlying | |
|
Granted to | |
|
Exercise or | |
|
|
|
Option Term(2) | |
| |
|
Options | |
|
Employees in | |
|
Base Price | |
|
Expiration |
|
| |
| Name |
|
Granted (#) | |
|
Fiscal Year(1) | |
|
($/Sh) | |
|
Date |
|
5% ($) |
|
10% ($) | |
| |
|
| |
|
| |
|
| |
|
|
|
|
|
| |
|
Patrick K. Donnelly
|
|
|
90,000 |
|
|
|
8.16% |
|
|
|
19.00 |
|
|
11/17/2011 |
|
696,142 |
|
|
1,622,306 |
|
|
David W. Dockhorn
|
|
|
50,000 |
|
|
|
4.54% |
|
|
|
19.00 |
|
|
11/17/2011 |
|
386,745 |
|
|
901,281 |
|
|
Erich Mohr
|
|
|
50,000 |
|
|
|
4.54% |
|
|
|
19.00 |
|
|
11/17/2011 |
|
386,745 |
|
|
901,281 |
|
|
James C. Powers
|
|
|
50,000 |
|
|
|
4.54% |
|
|
|
19.00 |
|
|
11/17/2011 |
|
386,745 |
|
|
901,281 |
|
|
Bruce A. Teplitzky
|
|
|
25,000 |
|
|
|
2.27% |
|
|
|
19.00 |
|
|
11/17/2011 |
|
193,373 |
|
|
450,641 |
|
|
|
|
|
| |
(1) |
Computed based on a total of 1,102,500 common shares underlying
stock options granted to our employees during 2004. |
|
| |
| |
(2) |
Amounts of potential realizable value represent hypothetical
gains that could be achieved for the respective stock options if
exercised at the end of the option term, based on assumed rates
of appreciation in the value of our common stock from the fair
market value on the date of grant. Potential realizable values
in the table above are calculated by: |
|
|
|
|
|
| |
• |
multiplying the number of shares of common stock subject to the
stock option by the initial public offering price of
$19.00 per share; |
|
| |
| |
• |
assuming that the aggregate share value derived from that
calculation compounds at the annual 5% or 10% rates shown in the
table for the balance of the term of the option; and |
|
| |
| |
• |
subtracting from that result the total option exercise price. |
|
|
|
| |
The 5% and 10% assumed rates of appreciation are suggested by
the rules of the SEC and do not represent our estimate or
projection of the future common share price. Actual gains, if
any, on stock option exercises will depend upon the future
performance of our common stock. |
The following table sets forth, for our named executive
officers, certain information concerning options exercised
during fiscal 2004 and the number of shares subject to both
exercisable and unexercisable stock options as of
December 31, 2004. For purposes of computing value realized
from the exercise of options in 2004, the fair market value for
periods prior to our initial public offering was determined by
reference to the exercise price of options granted closest to
the date that a named executive officer exercised options. For
those options exercised in association with our initial public
offering, the public offering price was used. The values for
“in-the-money” options are calculated by determining
the difference between the fair
63
market value of the securities underlying the options as of
December 31, 2004 ($25.09 per share) and the exercise
price of the officer’s options:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
Number of Securities | |
|
|
| |
|
|
|
|
|
Underlying Unexercised | |
|
Value of Unexercised | |
| |
|
Shares | |
|
|
|
Options at | |
|
In-The-Money Options at | |
| |
|
Acquired on | |
|
Value | |
|
December 31, 2004 (#) | |
|
December 31, 2004 ($) | |
| |
|
Exercise | |
|
Realized | |
|
| |
|
| |
| |
|
(#) | |
|
($) | |
|
Exercisable | |
|
Unexercisable | |
|
Exercisable | |
|
Unexercisable | |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Patrick K. Donnelly
|
|
|
138,008 |
|
|
|
1,189,847 |
|
|
|
368,736 |
|
|
|
194,000 |
|
|
|
7,835,724 |
|
|
|
2,737,514 |
|
|
David W. Dockhorn
|
|
|
177,074 |
|
|
|
1,430,620 |
|
|
|
121,526 |
|
|
|
137,000 |
|
|
|
2,532,263 |
|
|
|
1,868,760 |
|
|
Erich Mohr
|
|
|
— |
|
|
|
— |
|
|
|
48,000 |
|
|
|
66,000 |
|
|
|
889,320 |
|
|
|
600,940 |
|
|
James C. Powers
|
|
|
439,312 |
|
|
|
4,016,527 |
|
|
|
198,000 |
|
|
|
116,000 |
|
|
|
4,160,734 |
|
|
|
1,691,411 |
|
|
Bruce A. Teplitzky
|
|
|
125,153 |
|
|
|
1,021,905 |
|
|
|
72,971 |
|
|
|
72,000 |
|
|
|
1,473,306 |
|
|
|
1,137,910 |
|
Securities Authorized for Issuance Under Equity Compensation
Plans
The following table sets forth certain information as of
December 31, 2004 with respect to our compensation plans,
all of which have been approved by our stockholders, under which
equity securities of
the Company are authorized for issuance.
| |
|
|
|
|
| Number of Securities |
|
|
|
Number of Securities Remaining |
| to be Issued Upon |
|
Weighted-average |
|
Available for Future Issuance Under |
| Exercise of |
|
Exercise Price of |
|
Equity Compensation Plans (excluding |
| Outstanding Options, |
|
Outstanding Options, |
|
securities |
| Warrants and Rights(a) |
|
Warrants and Rights |
|
reflected in column(a)) |
| |
|
|
|
|
|
3,398,981
|
|
$8.46 per share |
|
2,023,738 |
Equity Compensation Plans
In connection with the initial public offering our board of
directors adopted the 2004 Incentive Award Plan, or the
Incentive Plan, which was submitted to our stockholders for
approval. The Incentive Plan terminates on the earlier of ten
years after stockholder approval or when the board of directors
terminates the Incentive Plan. The Incentive Plan provides for
the grant of incentive stock options, or ISOs, as defined in
Section 422 of the Internal Revenue Code of 1986, as
amended, or the Code, nonstatutory stock options, restricted
stock, restricted stock units, stock appreciation rights, or
SARs, deferred stock, dividend equivalent rights, performance
awards, and stock payments, all of which we collectively call
awards, to our employees, consultants, and directors.
Share Reserve
Reserved for issuance under the Incentive Plan, as of
May 15, 2005, upon grant or exercise of awards are
2,000,000 shares of our common stock plus
3,553,049 shares which have not been issued under the prior
plans or may be forfeited under outstanding options under the
prior plans. Once the Incentive Plan becomes subject to
Section 162(m) of the Code, no more than
750,000 shares may be granted pursuant to awards which are
intended to be performance-based compensation within the meaning
of Code Section 162(m) to any one participant in a
twelve-month period. The shares subject to the Incentive Plan,
the limitations on the number of shares that may be awarded
under the Incentive Plan, and shares and option prices subject
to awards outstanding under the Incentive Plan may be adjusted
as the plan administrator deems appropriate to reflect stock
dividends, stock splits, combinations or exchanges of shares,
mergers, consolidations, spin-offs, recapitalizations, or other
distributions of our assets.
Shares withheld for taxes, shares used to pay the exercise price
of an option in a net exercise, and shares tendered to us to pay
the exercise price of an option or other award may be available
for future grants of awards under the Incentive Plan. In
addition, shares subject to stock awards that have expired, been
forfeited, or otherwise terminated without having been exercised
may be subject to new awards. Shares issued under the Incentive
Plan may be previously authorized but unissued shares or
reacquired shares bought on the open market or otherwise.
64