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Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2009

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from              to             

Commission File Number: 000-21244

 

 

PAREXEL INTERNATIONAL CORPORATION

(Exact name of registrant as specified in its charter)

 

 

 

Massachusetts   04-2776269

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

195 West Street

Waltham, Massachusetts

  02451
(Address of principal executive offices)   (Zip Code)

(781) 487-9900

Registrant’s telephone number, including area code

 

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ¨    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large Accelerated Filer   x    Accelerated Filer   ¨
Non-accelerated Filer   ¨  (Do not check if a smaller reporting company)    Smaller Reporting Company   ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  x

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: As of November 2, 2009, there were 58,151,245 shares of common stock outstanding.

 

 

 


Table of Contents

PAREXEL INTERNATIONAL CORPORATION

INDEX

 

Part I. Financial Information

   3

Item 1.

  

Financial Statements

   3

Condensed Consolidated Balance Sheets (Unaudited) September 30, 2009 and June 30, 2009

   3

Condensed Consolidated Statements of Income (Unaudited) Three Months Ended September  30, 2009 and 2008

   4

Condensed Consolidated Statements of Cash Flows (Unaudited) Three Months Ended September  30, 2009 and 2008

   5

Notes to Condensed Consolidated Financial Statements (Unaudited)

   6

Item 2.

  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   15

Item 3.

  

Quantitative and Qualitative Disclosure About Market Risk

   22

Item 4.

  

Controls And Procedures

   23

Part II. Other Information

   24

Item 1.

  

Legal Proceedings

   24

Item 1a.

  

Risk Factors

   24

Item 5.

  

Other Information

   35

Item 6.

  

Exhibits

   35

Signatures

   36

Exhibit Index

   37

 

2


Table of Contents

PART I. FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

PAREXEL INTERNATIONAL CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

(in thousands, except share and per share data)

 

     September 30, 2009     June 30, 2009  

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 96,689      $ 96,352   

Billed and unbilled accounts receivable, net

     492,018        481,321   

Prepaid expenses

     29,200        24,636   

Deferred tax assets

     21,383        21,268   

Income tax receivable

     12,858        7,631   

Other current assets

     17,324        16,215   
                

Total current assets

     669,472        647,423   

Property and equipment, net

     171,838        170,486   

Goodwill

     256,057        247,612   

Other intangible assets, net

     97,852        98,799   

Non-current deferred tax assets

     5,136        15,385   

Long-term income tax receivable

     21,668        21,308   

Other assets

     23,607        23,448   
                

Total assets

   $ 1,245,630      $ 1,224,461   
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Notes payable and current portion of long-term debt

   $ 32,080      $ 32,090   

Accounts payable

     26,753        31,648   

Deferred revenue

     270,922        266,453   

Accrued expenses

     27,945        34,937   

Accrued restructuring charges

     788        876   

Accrued employee benefits and withholdings

     62,064        59,638   

Current deferred tax liabilities

     16,970        18,110   

Other current liabilities

     13,739        11,966   
                

Total current liabilities

     451,261        455,718   

Long-term debt, net of current portion

     244,104        247,083   

Non-current deferred tax liabilities

     43,187        44,446   

Long-term accrued restructuring charges

     1,131        1,268   

Long-term tax liabilities

     54,256        47,881   

Other liabilities

     14,307        13,320   
                

Total liabilities

     808,246        809,716   

Stockholders’ equity:

    

Preferred stock — $.01 par value; shares authorized: 5,000,000; Series A junior participating preferred; Series A junior participating preferred stock - 50,000 shares designated, none issued and outstanding

     —          —     

Common stock — $.01 par value; shares authorized: 75,000,000; shares issued and outstanding: 57,889,281 at September 30, 2009 and 57,782,931 at June 30, 2009

     573        572   

Additional paid-in capital

     222,218        219,849   

Retained earnings

     217,633        205,192   

Accumulated other comprehensive loss

     (3,040     (10,868
                

Total stockholders’ equity

     437,384        414,745   
                

Total liabilities and stockholders’ equity

   $ 1,245,630      $ 1,224,461   
                

See notes to condensed consolidated financial statements.

 

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Table of Contents

PAREXEL INTERNATIONAL CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF INCOME (UNAUDITED)

(in thousands, except per share data)

 

     Three Months Ended  
     September 30, 2009     September 30, 2008  

Service revenue

   $ 259,763      $ 263,046   

Reimbursement revenue

     47,775        56,506   
                

Total revenue

     307,538        319,552   

Direct costs

   $ 166,829      $ 171,364   

Reimbursable out-of-pocket expenses

     47,775        56,506   

Selling, general and administrative

     60,353        57,725   

Depreciation

     11,569        9,929   

Amortization

     2,536        2,035   
                

Total costs and expenses

     289,062        297,559   

Income from operations

     18,476        21,993   

Interest income

     827        2,706   

Interest expense

     (3,756     (5,411

Miscellaneous income

     2,149        2,027   
                

Other expense

     (780     (678

Income before income taxes

     17,696        21,315   

Provision for income taxes

     5,255        7,696   
                

Net income

   $ 12,441      $ 13,619   
                

Earnings per common share

    

Basic

   $ 0.22      $ 0.24   

Diluted

   $ 0.21      $ 0.23   

Shares used in computing earnings per common share

    

Basic

     57,815        56,926   

Diluted

     58,135        58,164   

See notes to condensed consolidated financial statements.

 

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Table of Contents

PAREXEL INTERNATIONAL CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

(in thousands)

 

     Three Months Ended  
     September 30,
2009
    September 30,
2008
 

Cash flow from operating activities:

    

Net income

   $ 12,441      $ 13,619   

Adjustments to reconcile net income to net cash provided by operating activities:

    

Depreciation and amortization

     14,105        11,964   

Loss on disposal of fixed assets

     54        —     

Stock-based compensation

     1,550        1,603   

Changes in operating assets and liabilities

     (13,793     (33,459
                

Net cash provided by (used in) operating activities

     14,357        (6,273

Cash flow from investing activities:

    

Purchases of property and equipment

     (15,445     (19,163

Acquisition of businesses

     (13     (185,337

Proceeds from sale of assets

     59        104   
                

Net cash used in investing activities

     (15,399     (204,396

Cash flow from financing activities:

    

Proceeds from issuance of common stock

     821        2,673   

Borrowing under lines of credit

     24,000        298,961   

Repayments under lines of credit

     (26,500     (90,386

Repayments under long-term debt

     (315     —     
                

Net cash (used in) provided by financing activities

     (1,994     211,248   

Effect of exchange rate changes on cash and cash equivalents

     3,373        (4,344
                

Net increase (decrease) in cash and cash equivalents

     337        (3,765

Cash and cash equivalents at beginning of period

     96,352        51,918   
                

Cash and cash equivalents at end of period

   $ 96,689      $ 48,153   
                

Supplemental disclosures of cash flow information

    

Net cash paid during the period for:

    

Interest

   $ 3,768      $ 5,006   

Income taxes, net of refunds

   $ 4,214      $ 5,761   

Supplemental disclosures of investing activities

    

Fair value of assets acquired and goodwill

   $ 13      $ 227,183   

Liabilities assumed

     —          (41,846
                

Cash paid for acquisitions

   $ 13      $ 185,337   
                

See notes to condensed consolidated financial statements.

 

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PAREXEL INTERNATIONAL CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 1 – BASIS OF PRESENTATION

The accompanying unaudited condensed consolidated financial statements of PAREXEL International Corporation (“PAREXEL”, “the Company”, “we”, “our” or “us”) have been prepared in accordance with generally accepted accounting principles for interim financial information and the instructions of Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (primarily consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three months ended September 30, 2009 are not necessarily indicative of the results that may be expected for other quarters or the entire fiscal year. For further information, refer to the consolidated financial statements and footnotes thereto included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2009 (the “2009 10-K”).

Certain amounts for our fiscal year ended June 30, 2009 (“Fiscal Year 2009”) have been reclassified to conform to the presentation of such amounts for our fiscal year ending June 30, 2010 (“Fiscal Year 2010”), including non-controlling interest balances and expenses that were inconsequential to our consolidated financial statements.

NOTE 2 – EARNINGS PER SHARE

Basic earnings per share is computed by dividing net income for the period by the weighted average number of common shares outstanding during the period. Diluted earnings per share is computed by dividing net income by the weighted average number of common shares plus the dilutive effect of outstanding stock options and shares issuable under our employee stock purchase plan. From the calculation of diluted earnings per share, we excluded all unvested restricted stock and certain outstanding options to purchase 1,865,223 shares of common stock for the three months ended September 30, 2009, and we excluded all unvested restricted stock and certain outstanding options to purchase 301,500 shares of common stock for the three months ended September 30, 2008, because they were anti-dilutive. The following table outlines the basic and diluted earnings per common share computations:

 

     Three Months Ended
(in thousands, except per share data)    September 30, 2009    September 30, 2008

Net income

   $ 12,441    $ 13,619
             

Weighted average number of shares outstanding used in computing basic earnings per share

     57,815      56,926

Dilutive common stock equivalents

     320      1,238
             

Weighted average number of shares outstanding used in computing diluted earnings per share

     58,135      58,164
             

Basic earnings per share

   $ 0.22    $ 0.24

Diluted earnings per share

   $ 0.21    $ 0.23

NOTE 3 – COMPREHENSIVE INCOME (LOSS)

Comprehensive income has been calculated in accordance with Accounting Standards Committee (“ASC”) No. 220, “Comprehensive Income,” (formerly Statement of Financial Accounting Standards (“SFAS”) 130, “Reporting Comprehensive Income”). Comprehensive income (loss) for the three months ended September 30, 2009 and 2008 was as follows:

 

     Three Months Ended  
(in thousands)    September 30, 2009     September 30, 2008  

Net income

   $ 12,441      $ 13,619   

Unrealized loss on derivative instruments*

     (3,670     (309

Foreign currency translation

     11,498        (40,648
                

Comprehensive (loss) income

   $ 20,269      $ (27,338
                

 

*  net of deferred tax amounts (liability) asset

   $ (1,285   $ (205

 

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Table of Contents

PAREXEL INTERNATIONAL CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)—(Continued)

 

NOTE 4 – ACQUISITIONS

On August 14, 2008, we acquired ClinPhone plc (“ClinPhone”), a company traded on the London Stock Exchange, for approximately $172 million in cash, and repaid approximately $18 million of ClinPhone debt. By combining ClinPhone with our Perceptive Informatics (“Perceptive”) segment, Perceptive is now one of the industry’s largest providers of telecommunications and web-based (“eClinical”) technologies for clinical research. The combined business offers access to a broad array of eClinical technologies and resources, providing clients and service providers with the benefits of an extensive line of products and services throughout the entire clinical development lifecycle. We allocated the total purchase price to the tangible and intangible assets and liabilities acquired based on fair value, with any excess recorded as goodwill. The following table summarizes the final purchase price allocation for ClinPhone (in thousands):

 

Purchase Price:

  

Cash paid, net of cash acquired

   $ 185,306   
  

Transaction costs

     4,927   
           
  

Total

   $ 190,233   
           

Allocations:

  

Fair value of assets acquired

  
  

Accounts receivable

   $ 18,416   
  

Other current assets

     2,236   
  

Property and equipment, net

     12,796   
  

Goodwill

     124,722   
  

Tradename

     22,158   
  

In-process research and development

     224   
  

Other intangible assets, net

     68,413   
  

Liabilities assumed

  
  

Accounts payable

     (8,628
  

Current liabilities

     (14,693
  

Deferred revenue

     (478
  

Other liabilities

     (34,933
           
  

Net assets acquired

   $ 190,233   
           

The following table summarizes the details of our assessment of the intangible assets acquired in the ClinPhone transaction as of September 30, 2009 (in thousands):

 

Intangible Assets

   Weighted Average
Useful Life*
   Cost    Accumulated Amortization/
Foreign Currency Exchange
Impact
   Net

Customer relationships

   13.6 years    $ 35,757    $ 7,322    $ 28,435

Backlog

   4 years      6,326      2,600      3,726

Technology

   8 years      26,330      7,156      19,174
                       

Total intangible assets

      $ 68,413    $ 17,077    $ 51,336
                       

 

* The determination of the useful life of the customer relationships, backlog and technology was based, in part, on our own historical experience (in particular based upon the experience in our Perceptive business) in renewing or extending similar relationships and arrangements.

The following table sets forth the estimated amortization expense of intangible assets acquired in the ClinPhone transaction (in thousands):

 

     2010    2011    2012    2013    2014

Amortization expense

   $ 6,639    $ 6,567    $ 6,423    $ 6,103    $ 5,638

The following summary of (unaudited) pro forma consolidated results of operations have been prepared as if the acquisition of ClinPhone had occurred on July 1, 2007, the beginning of our Fiscal Year 2008 (in thousands, except per share data):

 

     Pro Forma
Three Months Ended September 30, 2008

Service revenue

   $ 274,608

Net income*

   $ 13,811

Basic EPS*

   $ 0.24

Diluted EPS*

   $ 0.24

 

* Inclusive of interest expense that would have been incurred on the debt used to acquire ClinPhone at an annual interest rate of 5.0%, amortization expenses that would have been incurred in connection with acquired customer relationships, technology, and backlog, and the elimination of non-recurring costs including ClinPhone interest expense and deal costs.

 

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PAREXEL INTERNATIONAL CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)—(Continued)

 

NOTE 5 – STOCK-BASED COMPENSATION

We account for stock-based compensation according to ASC 718, “Compensation—Stock Compensation” (formerly SFAS No. 123(R), “Share-Based Payment”). The compensation expense recognized in the three months ended September 30, 2009 and 2008 is presented in the following table.

 

     Three Months Ended
(in thousands)    September 30, 2009    September 30, 2008

Direct costs

   $ 776    $ 534

Selling, general and administrative

     774      1,069
             

Total stock-based compensation

   $ 1,550    $ 1,603
             

NOTE 6 – SEGMENT INFORMATION

PAREXEL is managed through three business segments:

 

   

CRS constitutes our core business and includes clinical trials management and biostatistics, data management and clinical pharmacology, as well as related medical advisory and investigator site services.

 

   

PCMS provides technical expertise and advice in such areas as drug development, regulatory affairs, and GMP compliance. PCMS also provides a full spectrum of market development, product development, targeted communications, and strategic reimbursement advisory services in support of product launch.

 

   

Perceptive provides information technology solutions designed to improve clients’ product development processes. Perceptive offers a portfolio of products and services that includes medical imaging services, ClinPhone randomization and trial supply management (“RTSM”), electronic data capture (“EDC”), clinical trial management systems (“CTMS”), web-based portals, systems integration, and patient diary applications.

We evaluate our segment performance and allocate resources based on service revenue and gross profit (service revenue less direct costs), while other operating costs are allocated and evaluated on a geographic basis. Accordingly, we do not include the impact of selling, general, and administrative expenses, depreciation and amortization expense, other income (expense), and income tax expense in segment profitability. We attribute revenue to individual countries based upon the revenue earned in the respective countries; however, inter-segment transactions are not included in service revenue. Furthermore, PAREXEL has a global infrastructure supporting its business segments, and therefore, assets are not identified by reportable segment.

 

     Three Months Ended
($ in thousands)    September 30, 2009    September 30, 2008

Service revenue

     

Clinical Research Services

   $ 202,324    $ 202,823

PAREXEL Consulting and MedCom Services

     28,821      30,111

Perceptive Informatics, Inc.

     28,618      30,112
             

Total service revenue

   $ 259,763    $ 263,046
             

Direct costs

     

Clinical Research Services

   $ 129,282    $ 131,902

PAREXEL Consulting and MedCom Services

     18,431      20,163

Perceptive Informatics, Inc.

     19,116      19,299
             

Total direct costs

   $ 166,829    $ 171,364
             

Gross profit

     

Clinical Research Services

   $ 73,042    $ 70,921

PAREXEL Consulting and MedCom Services

     10,390      9,948

Perceptive Informatics, Inc.

     9,502      10,813
             

Total gross profit

   $ 92,934    $ 91,682
             

 

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PAREXEL INTERNATIONAL CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)—(Continued)

 

NOTE 7 – RESTRUCTURING CHARGES

Current activity charged against the restructuring accrual in the three months ended September 30, 2009 was as follows:

 

($ in thousands)    Balance at
June 30, 2009
   Payments/Foreign
Currency Exchange
    Provision
Adjustments
   Balance at
September 30, 2009

Facilities-related charges

   $ 2,165    $ (246   —      $ 1,919

NOTE 8 – RECENTLY ISSUED ACCOUNTING STANDARDS

In October 2009, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2009-14, “Software (Topic 985): Certain Revenue Arrangements That Include Software Elements—a consensus of the FASB Emerging Issues Task Force (“EITF”)” (formerly EITF 09-3). ASU 2009-14 revises FASB ASC 985-605 to drop from its scope all tangible products containing both software and non-software components that operate together to deliver the products’ functions. ASU 2009-14 is effective for us in Fiscal Year 2011. We are currently evaluating the impact that the adoption of this guidance will have on our consolidated financial statements.

In October 2009, the FASB issued ASU No. 2009-13, “Revenue Recognition (Topic 605): Multiple-Deliverable Revenue Arrangements – a consensus of the FASB Emerging Issues Task Force” (formerly EITF 08-1), which amends the revenue recognition guidance for arrangements with multiple deliverables. The amendments to FASB ASC 605-25 allow vendors to account for products and services separately rather than as a combined unit. ASU 2009-14 will be effective for us in Fiscal Year 2011. We are currently evaluating the impact that the adoption of this guidance will have on our consolidated financial statements.

In December 2007, the FASB issued ASC 810-10-45, “Other Presentation Matters” (formerly SFAS 160, “Non-controlling Interests in Consolidated Financial Statements”). ASC 810-10-45 clarifies that a non-controlling interest in a subsidiary should be reported at fair value as equity in the consolidated financial statements. Consolidated net income should include the net income for both the parent and the non-controlling interest with disclosure of both amounts on the consolidated statement of income. The calculation of earnings per share will continue to be based on income amounts attributable to the parent. ASC 810-10-45 is effective for us in this reporting period. The adoption of this statement was inconsequential to our consolidated financial statements, and, accordingly, non-controlling interest balances have been included in other expenses and other liabilities, as applicable.

NOTE 9 – INCOME TAXES

We determine our global provision for corporate income taxes in accordance with the FASB ASC 740, “Income Taxes” (formerly SFAS 109 and Financial Accounting Standards Board Interpretation (“FIN”) 48). We recognize our deferred tax assets and liabilities based upon the effect of temporary differences between the book and tax basis of recorded assets and liabilities. Further, we follow a methodology by which a company must identify, recognize, measure and disclose in its financial statements the effects of any uncertain tax return reporting positions that a company has taken or expects to take. Our financial statement reporting of the expected future tax consequences of uncertain tax return reporting positions is based on the presumption that all relevant tax authorities possess full knowledge of those tax reporting positions, as well as all of the pertinent facts and circumstances.

As of June 30, 2009, we had $58.3 million of gross unrecognized tax benefits, of which $15.6 million would impact the effective tax rate if recognized. As of September 30, 2009, we had $66.1 million of gross unrecognized tax benefits, of which $22.5 million would impact the effective tax rate if recognized. This reserve primarily relates to exposures for income tax matters such as changes in the jurisdiction in which income is taxable and taxation of certain investments. The $7.8 million net increase in gross unrecognized tax benefits is primarily composed of $6.9 million in reserves established in conjunction with the acquisition of ClinPhone Group Limited in Fiscal Year 2009, which did not impact the effective tax rate.

As of September 30, 2009, we anticipate that the liability for unrecognized tax benefits for uncertain tax positions would decrease by approximately $0.6 million in the next twelve months primarily as a result of the resolution of tax audits.

Our historical practice has been, and continues to be, to recognize interest and penalties related to income tax matters in income tax expense. As of June 30, 2009, $11.0 million of gross interest and penalties were included in our liability for unrecognized tax benefits. Income tax expense recorded through September 30, 2009 includes a benefit of approximately $0.3 million of interest and penalties. As of September 30, 2009, $10.7 million of interest and penalties were included in our liability for unrecognized tax benefits.

 

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PAREXEL INTERNATIONAL CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)—(Continued)

 

We are subject to U.S. federal income tax, as well as income tax in multiple state, local and foreign jurisdictions. All material U.S. state, local and federal income tax matters through 2002 have been concluded. Substantially all material foreign income tax matters have been concluded for all years through 1996.

For the three months ended September 30, 2009 and 2008, we had an effective income tax rate of 29.8% and 35.4% respectively. The decrease in the tax rate for the three months ended September 30, 2009, compared with the same period in 2008, was primarily attributable to a $1.0 million reduction in prior year interest accrued on tax reserves.

NOTE 10 – LINES OF CREDIT

2008 Credit Facility

On June 13, 2008, PAREXEL, certain subsidiaries of PAREXEL, JPMorgan Chase Bank, N.A., as Administrative Agent, J.P. Morgan Europe Limited, as London Agent, and the lenders party thereto (the “Lenders”) entered into an agreement for a credit facility (as amended and restated as of August 14, 2008 and as further amended by the first amendment thereto dated as of December 19, 2008, the “2008 Credit Facility”) in the principal amount of up to $315 million (collectively, the “Loan Amount”). The 2008 Credit Facility consists of an unsecured term loan facility and an unsecured revolving credit facility. Of the total principal amount, up to $150 million is made available through a term loan and up to $165 million is made available through a revolving credit facility. A portion of the revolving loan facility is available for swingline loans of up to $20 million to be made by JP Morgan Chase Bank, N.A. and for letters of credit. We may request the lenders to increase the 2008 Credit Facility by an additional amount of up to $50 million. Such increase may, but is not committed to, be provided.

Borrowings made under the 2008 Credit Facility bear interest, at our determination, at a rate based on the highest of prime, the federal funds rate plus .50% and the one-month Adjusted LIBOR Rate (as defined in the 2008 Credit Facility) plus 1.00% (such highest rate, the “Alternate Base Rate”) plus a margin (not to exceed a per annum rate of .75%) based on the Leverage Ratio (defined below), in which case it is a floating interest rate, or based on LIBOR or EURIBOR plus a margin (not to exceed a per annum rate of 1.75%) based on the Leverage Ratio, in which case the interest rate is fixed at the beginning of each interest period for the balance of the interest period. An interest period is typically one, two, three, or six months. The “Leverage Ratio” is a ratio of the consolidated total debt to consolidated net income before interest, taxes, depreciation and amortization (“EBITDA”). Loans outstanding under the 2008 Credit Facility may be prepaid at any time in whole or in part without premium or penalty, other than customary breakage costs, if any. The 2008 Credit Facility terminates and any outstanding loans under it mature on June 13, 2013.

Repayment of the principal borrowed under the revolving credit facility (other than a swingline loan) is due on June 13, 2013. Repayment of principal borrowed under the term loan facility is as follows:

 

   

5% of principal borrowed was repaid by June 30, 2009;

 

   

20% of principal borrowed must be repaid during the one-year period from July 1, 2009 to June 30, 2010;

 

   

20% of principal borrowed must be repaid during the one-year period from July 1, 2010 to June 30, 2011;

 

   

25% of principal borrowed must be repaid during the one-year period from July 1, 2011 to June 30, 2012; and

 

   

30% of principal borrowed must be repaid during the period from July 1, 2012 to June 13, 2013.

All payments of principal on the term loan facility made during each annual described above are required to be made in equal quarterly installments and to be accompanied by accrued interest thereon. To the extent not previously paid, all borrowings under the term loan facility must be repaid on June 13, 2013. Swingline loans under the 2008 Credit Facility generally must be paid on the first date after such swingline loan is made that is the 15th or last day of a calendar month.

Interest due under the revolving credit facility (other than a swingline loan) and the term loan facility must be paid quarterly for borrowings with an interest rate determined at the Alternate Base Rate. Interest must be paid on the last day of the interest period selected by us for borrowings with an interest rate based on LIBOR or EURIBOR; provided that for interest periods of longer than three months, interest is required to be paid every three months. Interest under swingline loans is payable when principal is required to be repaid.

Our obligations under the 2008 Credit Facility may be accelerated upon the occurrence of an event of default under the 2008 Credit Facility, which includes customary events of default, including payment defaults, defaults in the performance of affirmative and negative covenants, the inaccuracy of representations or warranties, bankruptcy and insolvency related defaults, cross defaults to other material indebtedness, defaults relating to such matters as ERISA and judgments, and a change of control default. Our obligations under the 2008 Credit Facility are guaranteed by certain of our U.S. domestic subsidiaries, and we have guaranteed any obligations of any co-borrowers under the 2008 Credit Facility.

 

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PAREXEL INTERNATIONAL CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)—(Continued)

 

In connection with the 2008 Credit Facility, we agreed to pay a commitment fee on the term loan commitment, payable quarterly calculated as a percentage of the unused amount of the term loan commitments at a per annum rate of 0.30%, and a commitment fee on the revolving loan commitment calculated as a percentage of the unused amount of the revolving loan commitments at a per annum rate of up to 0.375% (based on the Leverage Ratio). To the extent there are letters of credit outstanding under the 2008 Credit Facility, we will pay to the Administrative Agent, for the benefit of the lenders, and to the issuing bank certain letter of credit fees, a fronting fee and additional charges. We also agreed to pay various fees to JPMorgan Chase Bank, N.A. or KeyBank or both.

As of September 30, 2009, we had $271.0 million in principal amount of debt outstanding under the 2008 Credit Facility, consisting of $136.0 million of principal borrowed under the revolving credit facility and $135.0 million of principal under the term loan, and remaining borrowing availability of approximately $29.0 million under the revolving credit facility. Principal in the amount of $150 million under the 2008 Credit Facility has been hedged with an interest rate swap agreement and carries an interest rate of 4.8%. Currently, our debt under the 2008 Credit Facility, including the $150 million of principal hedged with an interest swap agreement, carries an average interest rate of 3.2%.

The 2008 Credit Facility contains affirmative and negative covenants applicable to us and our subsidiaries, including financial covenants requiring us to comply with maximum leverage ratios, minimum interest coverage ratios, a minimum net worth test (which covenant allows for foreign translation adjustments of up to $50 million in connection with the calculations required under such covenant) and maximum capital expenditures requirements, as well as restrictions on liens, investments, indebtedness, fundamental changes, acquisitions, dispositions of property, making specified restricted payments (including stock repurchases exceeding an agreed to percentage of consolidated net income), and transactions with affiliates. As of September 30, 2009, we were in compliance with all covenants under the 2008 Credit Facility.

Additional Lines of Credit

We have a line of credit with ABN AMRO Bank, NV in the amount of Euro 12.0 million. This line of credit is not collateralized, is payable on demand, and bears interest at an annual rate ranging between 2% and 4%. The line of credit may be revoked or canceled by ABN AMRO Bank, NV at any time at its discretion. We entered into this line of credit primarily to facilitate business transactions with ABN AMRO Bank, NV. At September 30, 2009, we had Euro 12.0 million available under this line of credit.

We also have a line of credit with HSBC UK in the amount of 2.0 million pounds sterling. This line of credit was established by ClinPhone and is guaranteed by PAREXEL International Holding BV. The line is not secured and bears interest at an annual rate ranging between 2% and 4%. At September 30, 2009, we had 2.0 million pounds sterling available under this line of credit.

We have an unsecured line of credit with JP Morgan UK in the amount of $4.5 million that bears interest at an annual rate ranging between 2% and 4%. We entered into this line of credit primarily to facilitate business transactions with JP Morgan UK. At September 30, 2009, we had $4.5 million available under this line of credit.

We have a cash pooling arrangement with ABN AMRO Bank. Pooling occurs when debit balances are offset against credit balances and the overall net position is used as a basis by the bank for calculating the overall pool interest amount. Each legal entity owned by PAREXEL and party to this arrangement remains the owner of either a credit (deposit) or a debit (overdraft) balance. Therefore, interest income is earned by legal entities with credit balances, while interest expense is charged to legal entities with debit balances. Based on the pool’s overall balance, the bank then (1) recalculates the overall interest to be charged or earned, (2) compares this amount with the sum of previously charged/earned interest amounts per account and (3) additionally pays/charges the difference. The gross overdraft balance related to this pooling arrangement was $137.4 million and $117.9 million at September 30, 2009 and June 30, 2009, respectively.

We have financing agreements with a vendor to finance software purchases. The agreements carry four-year terms and bear annual interest rates ranging between 0% to 3%. The balance on the promissory notes issued in connection with the financing agreements was $5.4 million and $5.7 million at September 30, 2009 and June 30, 2009, respectively.

NOTE 11 – COMMITMENTS, CONTINGENCIES AND GUARANTEES

As of September 30, 2009, we had approximately $38.5 million in purchase obligations with various vendors for the purchase of computer software and other services.

The 2008 Credit Facility, our unsecured senior credit facility, consists of a term loan facility for $150 million and a revolving credit facility for $165 million with a group of lenders (including and managed by JPMorgan Chase Bank, N.A.), and it is guaranteed by certain of our U.S. subsidiaries.

 

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PAREXEL INTERNATIONAL CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)—(Continued)

 

We have letter-of-credit agreements with banks totaling approximately $6.7 million guaranteeing performance under various operating leases and vendor agreements.

In March 2006, we conducted a Phase I clinical trial on behalf of TeGenero AG, a German pharmaceutical company. During the trial, six participants experienced adverse reactions to the TeGenero compound being tested. In the first quarter of Fiscal Year 2010, we reached final settlement agreements with these participants. All amounts were paid by insurance companies.

We periodically become involved in various claims and lawsuits that are incidental to our business. We believe, after consultation with counsel, that no matters currently pending would, in the event of an adverse outcome, have a material impact on our consolidated financial position, results of operations, or liquidity.

NOTE 12 – DERIVATIVES

It is our policy to mitigate the risks associated with fluctuations in foreign exchange rates and in market rates of interest. Accordingly, we have instituted foreign currency hedging programs and an interest rate swap program that are accounted for in accordance with ASC 815, “Derivatives and Hedging” (formerly SFAS No. 133, “Accounting for Derivative Instruments and Hedging Activities”).

 

   

Our foreign denominated intercompany debt and accounts receivable hedging program is a cash flow hedge program designed to minimize foreign currency volatility. The objective of the program is to reduce variability of cash flows with respect to forecasted billing for services provided outside of the currency underlying the service contract with our customer and the foreign exchange exposure related to payment of invoices for services provided in executing the customer contract. We primarily utilize forward exchange contracts and purchased currency options with maturities of no more than 12 months that qualify as cash flow hedges. These are intended to offset the effect of exchange rate fluctuations as services are performed and billed, and are generally expected to be reclassified to earnings in the next 12 months as the underlying transactions occur.

 

   

Under our interest rate hedging program, we swap the difference between fixed and variable interest amounts calculated by reference to an agreed-upon notional principal amount, at specified intervals. The objective of this program is to reduce the variability of cash flows related to fluctuations in market rates of interest.

Occasionally, we enter into other foreign currency exchange contracts to offset the impact of currency fluctuations for other currencies and intercompany billings. These hedges include cash flow hedges similar to those described above, but may involve other denominations or counterparties and are not accounted for as hedges in accordance with ASC 815.

The following table presents the notional amounts and fair values of our derivatives as of September 30, 2009 and June 30, 2009 (in thousands). All amounts are reported in other current assets and other current liabilities.

 

     September 30, 2009     June 30, 2009  
     Notional
Amount
   Asset
(Liability)
    Notional
Amount
   Asset
(Liability)
 

Derivatives designated as hedging instruments under ASC 815

          

Interest rate contracts

   $ 150,000    $ (6,257   $ 150,000    $ (5,381

Foreign exchange contracts

     180,635      2,632        54,459      5,584   
                              

Total designated derivatives

   $ 330,635    $ (3,625   $ 204,459    $ 203   

Derivatives not designated as hedging instruments under ASC 815

          

Interest rate contracts

   $ 43,872    $ 170      $ —      $ —     

Foreign exchange contracts

     77,221      3,176        197,086      1,764   
                              

Total non-designated derivatives

   $ 121,093    $ 3,346      $ 197,086    $ 1,764   
                              

Total derivatives

   $ 451,728    $ (279   $ 401,545    $ 1,967   
                              

 

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PAREXEL INTERNATIONAL CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)—(Continued)

 

The change in the fair value of derivatives designated as hedging instruments under ASC 815 is recorded to other comprehensive income (loss) on the balance sheet. The amounts recognized for the three months ended September 30, 2009 and 2008 are presented below (in thousands):

 

     Three Months Ended  
     September 30, 2009     September 30, 2008  

Derivatives designated as hedging instruments under ASC 815

    

Interest rate contracts

   $ (569   $ 1,400   

Foreign exchange contracts

     (2,014     (1,709
                

Total designated derivatives

   $ (2,583   $ (309
                

The change in the fair value of derivatives not designated as hedging instruments under ASC 815 is recorded to miscellaneous income on the income statement. The amounts recognized for the three months ended September 30, 2009 and 2008 are presented below (in thousands):

 

     Three Months Ended  
     September 30, 2009    September 30, 2008  

Derivatives not designated as hedging instruments under ASC 815

     

Interest rate contracts

   $ 170    $ —     

Foreign exchange contracts

     1,412      (1,656
               

Total non-designated derivatives

   $ 1,582    $ (1,656
               

NOTE 13. FAIR VALUE MEASUREMENTS

We apply the provisions of ASC 820, “Fair Value Measurements and Disclosures” (formerly SFAS 157, “Fair Value Measurements”). ASC 820 defines fair value and provides guidance for measuring fair value and expands disclosures about fair value measurements. ASC 820 enables the reader of financial statements to assess the inputs used to develop those measurements by establishing a hierarchy for ranking the quality and reliability of the information used to determine fair values. ASC 820 requires that assets and liabilities carried at fair value be classified and disclosed in one of the following three categories:

 

   

Level 1 – Unadjusted quoted prices in active markets that are accessible to the reporting entity at the measurement date for identical assets and liabilities.

 

   

Level 2 – Inputs other than quoted prices in active markets for identical assets and liabilities that are observable either directly or indirectly for substantially the full term of the asset or liability. Level 2 inputs include the following:

 

   

quoted prices for similar assets and liabilities in active markets

 

   

quoted prices for identical or similar assets or liabilities in markets that are not active

 

   

observable inputs other than quoted prices that are used in the valuation of the asset or liabilities (e.g., interest rate and yield curve quotes at commonly quoted intervals)

 

   

inputs that are derived principally from or corroborated by observable market data by correlation or other means

 

   

Level 3 – Unobservable inputs for the assets or liability (i.e., supported by little or no market activity). Level 3 inputs include management’s own assumption about the assumptions that market participants would use in pricing the asset or liability (including assumptions about risk).

The following table sets forth by level, within the fair value hierarchy, our assets (liabilities) carried at fair value as of September 30, 2009:

 

     Level 1    Level 2     Level 3    Total  

Interest Rate Derivative Instruments

   $ —      $ (6,087   $ —      $ (6,087

Foreign Currency Exchange Contracts

     —        5,808        —        5,808   
                              

Total

   $ —      $ (279     —      $ (279
                              

 

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PAREXEL INTERNATIONAL CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)—(Continued)

 

Foreign currency exchange contracts are measured at fair value using the market method valuation technique. The inputs to this technique utilize current foreign currency exchange forward market rates published by third-party leading financial news and data providers. This is observable data that represent the rates that the financial institution uses for contracts entered into at that date; however, they are not based on actual transactions so they are classified as Level 2. We record changes in the fair value of these contracts, to the extent they are effective as cash flow hedges, in other comprehensive income. If a contract does not qualify for hedge accounting, changes in the fair value of the contract are recorded in income.

The carrying value of our short-term and long-term debt approximates fair value because all of the debt bears variable rate interest.

NOTE 14. SUBSEQUENT EVENTS

In October 2009, we adopted a plan to restructure our operations to reduce expenses, better align costs with current and future geographic sources of revenue, and improve operating efficiencies. These actions are expected to result in a pre-tax charge of approximately $30 million in the quarter ending December 31, 2009. The charge is primarily related to expenses to be incurred in connection with the consolidation or closure of certain offices, the reduction of approximately 4% of our workforce, and certain other one-time costs. We anticipate that we will substantially complete these restructuring activities by June 30, 2010. The charges will include approximately $7 million in costs related to the abandonment of certain property leases, approximately $22 million in employee separation benefits, and approximately $1 million in other one-time costs. We expect a majority of the $30 million charge to be paid out in the second half of Fiscal Year 2010, with the remainder to be paid out over several years, in the form of cash expenditures. We expect the charge to result in annual pre-tax savings of approximately $21 million when completed.

We have evaluated subsequent events through the date of this filing, November 6, 2009.

 

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The financial information discussed below is derived from the Condensed Consolidated Financial Statements included in this quarterly report on Form 10-Q. The financial information set forth and discussed below is unaudited but, in the opinion of management, reflects all adjustments (primarily consisting of normal recurring adjustments) considered necessary for a fair presentation of such information. Our results of operations for a particular quarter may not be indicative of results expected during subsequent fiscal quarters or for the entire year.

This quarterly report on Form 10-Q includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 27A of the Securities Act of 1933, as amended. For this purpose, any statements contained in this report regarding our strategy, future operations, financial position, future revenue, projected costs, prospects, plans and objectives of management, other than statements of historical facts, are forward-looking statements. The words “anticipates,” “believes,” “estimates,” “expects,” “appears,” “intends,” “may,” “plans,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations expressed or implied in our forward-looking statements. There are a number of important factors that could cause actual results, levels of activity, performance or events to differ materially from those expressed or implied in the forward-looking statements we make. These important factors are described under “Critical Accounting Policies and Estimates” included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2009, filed on August 28, 2009 (the “2009 10-K”), and under “Risk Factors” set forth in Part II, Item 1A below. In light of these risks, uncertainties, assumptions and factors, the forward-looking events discussed herein may not occur and our actual performance and results may vary from those anticipated or otherwise suggested by such statements. You are cautioned not to place undue reliance on these forward-looking statements. Although we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and readers should not rely on those forward-looking statements as representing our views as of any date subsequent to the date of this quarterly report.

OVERVIEW

We are a leading biopharmaceutical services company, providing a broad range of expertise in clinical research, medical communications services, consulting and informatics and advanced technology products and services to the worldwide pharmaceutical, biotechnology, and medical device industries. Our primary objective is to provide solutions for managing the biopharmaceutical product lifecycle with the goal of reducing the time, risk, and cost associated with the development and commercialization of new therapies. Since our incorporation in 1983, we have developed significant expertise in processes and technologies supporting this strategy. Our product and service offerings include: clinical trials management, data management, biostatistical analysis, medical communications services, clinical pharmacology, patient recruitment, regulatory and product development consulting, health policy and reimbursement, performance improvement, industry, medical imaging services, ClinPhone RTSM, CTMS, EDC, web-based portals, systems integration, patient diary applications, and other drug development consulting services. We believe that our comprehensive services, depth of therapeutic area expertise, global footprint and related access to patients, and sophisticated information technology, along with our experience in global drug development and product launch services, represent key competitive strengths.

We are managed through three business segments: CRS, PCMS and Perceptive.

 

   

CRS constitutes our core business and includes all phases of clinical research from Early Phase (encompassing the early stages of clinical testing that range from first-in-man through proof-of-concept studies, formerly referred to as “Clinical Pharmacology”) to Late Phase (encompassing the later stages of clinical testing, formerly referred to as “Phases II-IV”). Our services include clinical trials management and biostatistics, data management and clinical pharmacology, as well as related medical advisory, patient recruitment, clinical supply and drug logistics, pharmacovigilance, and investigator site services.

 

   

PCMS provides technical expertise and advice in such areas as drug development, regulatory affairs, and biopharmaceutical process and management consulting. PCMS also provides a full spectrum of market development, product development, and targeted communications services in support of product launch. PCMS consultants identify alternatives and propose solutions to address clients’ product development, registration, and commercialization issues. PCMS also provides health policy consulting and strategic reimbursement services.

 

   

Perceptive provides information technology solutions designed to improve clients’ product development processes. Perceptive offers a portfolio of products and services that includes medical imaging services, ClinPhone RTSM, CTMS, EDC, web-based portals, systems integration, and patient diary applications.

 

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CRITICAL ACCOUNTING POLICIES AND ESTIMATES

The discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses, and other financial information. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various other factors that we believe to be reasonable under the circumstances. Our actual results may differ from these estimates under different assumptions or conditions. Our most critical accounting policies involve: revenue recognition, billed accounts receivable, unbilled accounts receivable and deferred revenue, accounting for income taxes, and goodwill. For further information, please refer to the consolidated financial statements and footnotes thereto included in the 2009 10-K.

GOODWILL

Goodwill represents the excess of the cost of an acquired business over the fair value of the related net assets at the date of acquisition. We completed our annual impairment testing in the fourth quarter of Fiscal Year 2009 and determined that there were no required adjustments to the carrying value of goodwill at any of our reporting units. The impairment testing involves determining the fair market value of each of the reporting units with which the goodwill was associated and comparing that value with the reporting unit’s carrying value. We determined fair value using a discounted cash flow analysis at the reporting unit level. This analysis included significant judgment regarding the assumptions used, such as our weighted average cost of capital, revenue growth rates, profit margins, capital expenditures, and other factors that were all based on current strategic forecasts and other financial metrics. As of September 30, 2009, we do not believe that any of our reporting units are at risk of failing this initial step of goodwill impairment testing.

RESULTS OF OPERATIONS

ANALYSIS BY SEGMENT

We evaluate our segment performance and allocate resources based on service revenue and gross profit (service revenue less direct costs), while other operating costs are allocated and evaluated on a geographic basis. Accordingly, we do not include the impact of selling, general, and administrative expenses, depreciation and amortization expense, other charges, interest income (expense), other income (loss), and income tax expense (benefit) in segment profitability. We attribute revenue to individual countries based upon the number of hours of services performed in the respective countries. Inter-segment transactions are not included in service revenue. Furthermore, we have a global infrastructure supporting our business segments, and therefore, we do not identify assets by reportable segment. Service revenue, direct costs and gross profit on service revenue for the three months ended September 30, 2009 and 2008 were as follows:

 

     Three Months Ended    Increase
(Decrease)
    %  
($ in thousands)    September 30, 2009    September 30, 2008     

Service revenue

          

Clinical Research Services

   $ 202,324    $ 202,823    $ (499   -0.2

PAREXEL Consulting and MedCom Services

     28,821      30,111      (1,290   -4.3

Perceptive Informatics, Inc.

     28,618      30,112      (1,494   -5.0
                        

Total service revenue

   $ 259,763    $ 263,046    $ (3,283   -1.2
                        

Direct costs

          

Clinical Research Services

   $ 129,282    $ 131,902    $ (2,620   -2.0

PAREXEL Consulting and MedCom Services

     18,431      20,163      (1,732   -8.6

Perceptive Informatics, Inc.

     19,116      19,299      (183   -0.9
                        

Total direct costs

   $ 166,829    $ 171,364    $ (4,535   -2.6
                        

Gross profit

          

Clinical Research Services

   $ 73,042    $ 70,921    $ 2,121      3.0

PAREXEL Consulting and MedCom Services

     10,390      9,948      442      4.4

Perceptive Informatics, Inc.

     9,502      10,813      (1,311   -12.1
                        

Total gross profit

   $ 92,934    $ 91,682    $ 1,252      1.4
                        

 

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Three Months Ended September 30, 2009 Compared With Three Months Ended September 30, 2008:

For the three months ended September 30, 2009, we had net income of $12.4 million compared with net income of $13.6 million for the three months ended September 30, 2008. On a fully diluted basis, earnings per share decreased slightly to $0.21 from $0.23 for the respective periods.

Revenues

Service revenue decreased by $3.2 million, or 1.2%, to $259.8 million for the three months ended September 30, 2009 from $263.0 million for the three months ended September 30, 2008. On a geographic basis, service revenue was distributed as follows (in millions):

 

     Three months ended September 30, 2009     Three months ended September 30, 2008  
Region    Service Revenue    % of Total     Service Revenue    % of Total  

The Americas

   $ 101.6    39.1   $ 102.3    38.9

Europe, Middle East & Africa

   $ 129.6    49.9   $ 140.4    53.4

Asia/Pacific

   $ 28.6    11.0   $ 20.3    7.7

Service revenue in The Americas decreased by $0.7 million, or 0.7%; Europe, Middle East & Africa service revenue decreased by $10.8 million, or 7.7%; and Asia/Pacific service revenue increased by $8.3 million, or 40.8%. Service revenue in Europe, Middle East & Africa was negatively impacted by foreign currency fluctuations of approximately $14.8 million. The negative impact of foreign currency fluctuations in the Americas was approximately $2.3 million, while the impact in Asia/Pacific was minimal.

On a segment basis, CRS service revenue decreased slightly to $202.3 million for the three months ended September 30, 2009 from $202.8 million for the three months ended September 30, 2008. The $0.5 million decrease was attributable to approximately $12.0 million related to the negative impact of foreign currency fluctuations and a $4.7 million decrease in our Early Phase business due, in part, to weakness in the small biopharma market segment; partially offset by a $16.2 million increase in the Late Phase portions of the business as a result of growth in the Americas and Asia/Pacific regions.

PCMS service revenue decreased by $1.3 million, or 4.3%, to $28.8 million for the three months ended September 30, 2009 from $30.1 million for the same period in 2008. The decrease was due primarily to the negative $2.2 million impact of foreign currency fluctuations; partially offset by a net $0.9 million increase in our business, particularly in consulting services.

Perceptive service revenue decreased by $1.5 million, or 5.0%, to $28.6 million for the three months ended September 30, 2009 from $30.1 million for the three months ended September 30, 2008. The decrease was due primarily to the negative $2.0 million impact of foreign currency fluctuations; partially offset by a $0.3 million increase in revenues from ClinPhone (which was acquired in August 2008) and a net $0.2 million increase in our other service lines, including growth in our product support fees and medical imaging. Perceptive revenue for the three months ended September 30, 2008 included $5.7 million related to certain accounting adjustments that were subsequently reversed in the fourth quarter of Fiscal Year 2009.

Reimbursement revenue consists of reimbursable out-of-pocket expenses incurred on behalf of and reimbursable by clients. Reimbursement revenue does not yield any gross profit to us, nor does it have an impact on net income.

Direct Costs

Direct costs decreased by $4.5 million, or 2.6%, to $166.8 million for the three months ended September 30, 2009 from $171.3 million for the three months ended September 30, 2008. As a percentage of total service revenue, direct costs decreased to 64.2% from 65.2% for the respective periods.

On a segment basis, CRS direct costs decreased by $2.6 million, or 2.0%, to $129.3 million for the three months ended September 30, 2009 from $131.9 million for the three months ended September 30, 2008. This decrease was due primarily to the positive impact of $6.3 million in foreign currency fluctuations and a $1.0 million decrease in our Early Phase business due to a lower volume of business; partially offset by a $4.7 million increase in our Late Phase business to support higher business volume. As a percentage of service revenue, CRS direct costs decreased to 63.9% for the three months ended September 30, 2009 from 65.0% for the three months ended September 30, 2008 due primarily to strong performance in Asia/Pacific, the continued effectiveness of cost controls, and improved productivity and efficiency.

PCMS direct costs decreased by $1.7 million, or 8.6%, to $18.4 million for the three months ended September 30, 2009 from $20.1 million for the three months ended September 30, 2008. This $1.7 million decline was due primarily to $0.6 million in decreases related to lower business activity and $1.1 million related to the impact of positive foreign currency fluctuations. As a percentage of service revenue, PCMS direct costs decreased to 63.9% from 67.0% for the respective periods. This reduction resulted from efforts by PCMS to implement substantial improvements in business processes, mainly related to the strategic marketing portion of the business and the shedding of certain unprofitable service lines.

 

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Perceptive direct costs decreased slightly by $0.2 million, or 1.0%, to $19.1 million for the three months ended September 30, 2009 from $19.3 million for the three months ended September 30, 2008. This decrease was due primarily to a $1.2 million decrease in our legacy IVRS business, a $0.9 million decrease in our medical imaging business and the positive impact of foreign currency fluctuations of approximately $0.8 million; partially offset by a $1.9 million increase in the direct costs of ClinPhone (which was acquired in August 2008) and a $0.8 million increase in our other business lines, primarily in the product support areas. As a percentage of service revenue, Perceptive direct costs increased to 66.8% for the three months ended September 30, 2009 from 64.1% for the three months ended September 30, 2008. This increase was due primarily to lower utilization rates and slower revenue growth.

Selling, General and Administrative

Selling, general and administrative (“SG&A”) expense increased by $2.6 million, or 4.6%, to $60.3 million for the three months ended September 30, 2009 from $57.7 million for the three months ended September 30, 2008. This increase was due primarily to a $3.8 million increase in the SG&A of ClinPhone (which was acquired in August 2008), $2.7 million from higher facilities costs, and $1.2 million from an increase in various other expenses including research and development, selling costs, and compensation; partially offset by $5.1 million attributable to foreign exchange fluctuations. As a percentage of service revenue, SG&A increased to 23.2% for the three months ended September 30, 2009 from 21.9% for the three months ended September 30, 2008 resulting from the slowdown in service revenue growth.

Depreciation and Amortization

Depreciation and amortization (“D&A”) expense increased by $2.1 million, or 17.9%, to $14.1 million for the three months ended September 30, 2009 from $12.0 million for the three months ended September 30, 2008, primarily due to incremental D&A expense associated with ClinPhone and additional depreciation expense due to increased capital expenditures. As a percentage of service revenue, D&A increased to 5.4% for the three months ended September 30, 2009 from 4.5% for the same period in 2008.

Other Income and Expense

We recorded net other expense of $0.8 million for the three months ended September 30, 2009 compared with net other expense of $0.7 million for the three months ended September 30, 2008.

Taxes

For the three months ended September 30, 2009 and 2008, we had an effective income tax rate of 29.8% and 35.4% respectively. The decrease in the tax rate for the three months ended September 30, 2009, compared with the same period in 2008, was primarily attributable to a $1.0 million reduction in prior year interest accrued on tax reserves.

LIQUIDITY AND CAPITAL RESOURCES

Since our inception, we have financed our operations and growth with cash flow from operations, proceeds from the sale of equity securities, and, more recently, credit facilities to fund business acquisitions. Investing activities primarily reflect the costs of acquisitions and capital expenditures for information systems enhancements and leasehold improvements. As of September 30, 2009, we had cash and cash equivalents of approximately $96.7 million.

DAYS SALES OUTSTANDING

Our operating cash flow is heavily influenced by changes in the levels of billed and unbilled receivables and deferred revenue. These account balances as well as days sales outstanding (“DSO”) in accounts receivable, net of deferred revenue, can vary based on contractual milestones and the timing and size of cash receipts. DSO was 58 days at September 30, 2009, 57 days at June 30, 2009, and 66 days at September 30, 2008. Accounts receivable, net of provision for losses on receivables, totaled $492.0 million ($255.7 million in billed accounts receivable and $236.3 million in unbilled accounts receivable) at September 30, 2009 and $481.3 million ($251.2 million in billed accounts receivable and $230.1 million in unbilled accounts receivable) at June 30, 2009 and $457.7 million ($253.7 million in billed accounts receivable and $204.0 million in unbilled accounts receivable) at September 30, 2008. Deferred revenue was $270.9 million at September 30, 2009, $266.5 million at June 30, 2009, and $195.6 million at September 30, 2008. We calculate DSO by adding the end-of-period balances for billed and unbilled account receivables, net of deferred revenue and the provision for losses on receivables, then dividing the resulting amount by the sum of total revenue plus investigator fees billed for the most recent quarter, and multiplying the resulting fraction by the number of days in the quarter.

 

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CASH FLOWS

Net cash provided by operating activities the three months ended September 30, 2009 totaled $14.4 million and was generated by net income of $12.4 million, non-cash charges for depreciation and amortization expense in the amount of $14.1 million, and $1.5 million related to non-cash charges for stock-based compensation. These sources of cash were offset by $13.6 million related to changes in operating assets and liabilities – composed of a $9.2 million increase in accounts receivable (net of allowance for doubtful accounts and deferred revenue), a $6.9 million increase in prepaid expenses and other current assets, and a $5.2 million increase in other assets; partly offset by a $7.7 million increase in taxes payable and other long-term liabilities.

Net cash used in investing activities for the three months ended September 30, 2009 totaled $15.4 million for capital expenditures, primarily computer software and hardware and leasehold improvements.

Net cash used in financing activities for the three months ended September 30, 2009 totaled $2.0 million, and consisted of $2.8 million of repayment under a line of credit; offset by $0.8 million in proceeds related to the issuance of common stock in conjunction with our stock option plan.

Net cash used in operating activities the three months ended September 30, 2008 totaled $6.3 million and was generated by net income of $13.6 million, non-cash charges for depreciation and amortization expense in the amount of $12.0 million, an increase in deferred income taxes of $8.8 million, $1.6 million related to non-cash charges for stock-based compensation, and $0.5 million of minority interest. These sources of cash were offset by a $20.6 million decrease in other current liabilities (mainly related to the payment of management bonuses), a $13.4 million decrease in accounts payable and other accrued expenses, a $3.9 million decrease in accounts receivable (net of allowance for doubtful accounts and deferred revenue), a $2.6 million decrease in long-term liabilities, and a $2.3 million decrease in other current assets and other assets.

Net cash used in investing activities for the three months ended September 30, 2008 totaled $204.4 million and consisted of $185.3 million for the acquisition of ClinPhone and $19.1 million of capital expenditures, primarily computer software and hardware and leasehold improvements.

Net cash provided by financing activities for the three months ended September 30, 2008 totaled $211.2 million, and consisted of $208.6 million of net borrowings under a line of credit and $2.6 million in proceeds related to the issuance of common stock in conjunction with our stock option plan. The increase in net borrowings was due primarily to the acquisition of ClinPhone.

LINES OF CREDIT

2008 Credit Facility

We have a line of credit (the “2008 Credit Facility”) with JPMorgan Chase Bank, N.A., as Administrative Agent, J.P. Morgan Europe Limited, as London Agent, and other lenders. The 2008 Credit Facility consists of an unsecured term loan facility of $150 million and an unsecured revolving credit facility of up to $165 million. A portion of the revolving loan facility is available for swingline loans of up to $20 million to be made by JP Morgan Chase Bank, N.A. and for letters of credit. We may request the lenders to increase the 2008 Credit Facility by an additional amount of up to $50 million, and such increase may, but is not committed to, be provided. Please see Note 10 to our Condensed Consolidated Financial Statements included in this quarterly report on Form 10-Q for more information on the 2008 Credit Facility.

As of September 30, 2009, we had $271.0 million in principal amount of debt outstanding under the 2008 Credit Facility, consisting of $136.0 million of principal borrowed under the revolving credit facility and $135.0 million of principal under the term loan, and remaining borrowing availability of approximately $29.0 million under the revolving credit facility. Principal in the amount of $150 million under the 2008 Credit Facility has been hedged with an interest rate swap agreement and carries an interest rate of 4.8%. Currently, our debt under the 2008 Credit Facility, including the $150 million of principal hedged with an interest swap agreement, carries an average interest rate of 3.2%.

Additional Lines of Credit

We have a line of credit with ABN AMRO Bank, NV in the amount of Euro 12.0 million. This line of credit is not collateralized, is payable on demand, and bears interest at an annual rate ranging between 2% and 4%. The line of credit may be revoked or canceled by ABN AMRO Bank, NV at any time at its discretion. We primarily entered into this line of credit to facilitate business transactions with ABN AMRO Bank, NV. At September 30, 2009, we had Euro 12.0 million available under this line of credit.

 

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We also have a line of credit with HSBC UK in the amount of 2.0 million pounds sterling. This line of credit was established by ClinPhone and is guaranteed by PAREXEL International Holding BV. The line is not secured and bears interest at an annual rate ranging between 2% and 4%. At September 30, 2009, we had 2.0 million pounds sterling available under this line of credit.

We have an unsecured line of credit with JP Morgan UK in the amount of $4.5 million that bears interest at an annual rate ranging between 2% and 4%. We entered into this line of credit primarily to facilitate business transactions with JP Morgan UK. At September 30, 2009, we had $4.5 million available under this line of credit.

We have a cash pooling arrangement with ABN AMRO Bank. Pooling occurs when debit balances are offset against credit balances and the overall net position is used as a basis by the bank for calculating the overall pool interest amount. Each legal entity owned by PAREXEL and party to this arrangement remains the owner of either a credit (deposit) or debit (overdraft) balance. Therefore, interest income is earned by legal entities with credit balances, while interest expense is charged to legal entities with debit balances. Based on the pool’s overall balance, the bank then (1) recalculates the overall interest to be charged or earned, (2) compares this amount with the sum of previously charged/earned interest amounts per account and (3) additionally pays/charges the difference. The gross overdraft balance related to this pooling arrangement was $137.4 million and $117.9 million at September 30, 2009 and June 30, 2009, respectively.

We have financing agreements with a vendor to finance software purchases. The agreements carry four-year terms and bear annual interest rates ranging between 0% to 3%. The balance on the promissory notes issued in connection with the financing agreements was $5.4 million and $5.7 million at September 30, 2009 and June 30, 2009, respectively.

FINANCING NEEDS

Our primary cash needs are for operating expenses, such as salaries and fringe benefits, hiring and recruiting, business development and facilities, and for business acquisitions, capital expenditures and repayment of principal and interest on our borrowings. Our requirements for cash to pay principal and interest on our borrowings will increase significantly in future periods because we borrowed approximately $192 million under the 2008 Credit Facility in August 2008 to finance the acquisition of ClinPhone. Our only committed external source of funds is under our 2008 Credit Facility described above. Our principal source of cash is from the performance of services under contracts with our clients. If we were unable to generate new contracts with existing and new clients or if the level of contract cancellations increased, our revenue and cash flow would be adversely affected (see “Part II, Item 1A - Risk Factors” for further detail). Absent a material adverse change in the level of our new business bookings or contract cancellations, we believe that our existing capital resources together with cash flow from operations and borrowing capacity under existing lines of credit will be sufficient to meet our foreseeable cash needs over the next twelve months and on a longer term basis. Depending upon our revenue and cash flow from operations, it is possible that we will require external funds to repay amounts outstanding under our 2008 Credit Facility upon maturity in 2013.

We expect to continue to acquire businesses to enhance our service and product offerings, expand our therapeutic expertise, and/or increase our global presence; however, we are currently focused on integrating our recent acquisitions. Depending on their size, any such acquisitions may require additional external financing, and we may from time to time seek to obtain funds from public or private issuances of equity or debt securities. We may be unable to secure such financing at all or on terms acceptable to us, as a result of our outstanding borrowings under the 2008 Credit Facility. In addition, under the terms of the 2008 Credit Facility, interest rates are fixed based on market indices at the time of borrowing and, depending upon the interest mechanism selected by us, may float thereafter. As a result, the amount of interest payable by us on our borrowings may increase if market interest rates change.

We made capital expenditures of approximately $15.4 million during the three months ended September 30, 2009, primarily for computer software and hardware and leasehold improvements. We expect capital expenditures to total approximately $70 to $75 million in Fiscal Year 2010 that will be funded by cash from operations or from draws under the 2008 Credit Facility. These capital expenditures will be primarily for computer software and hardware and leasehold improvements, as well as for our Leveraging Expertise and Process initiative (“LEAP”). LEAP is a re-engineering of the Late Phase Clinical Research Services operating model to meet evolving market needs. The goal of the redesign is to streamline and harmonize processes across operations and geographies, while improving productivity and quality through the use of our integrated eClinical technologies.

 

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COMMITMENTS, CONTINGENCIES AND GUARANTEES

As of September 30, 2009, we had approximately $38.5 million in purchase obligations with various vendors for the purchase of computer software and other services.

The 2008 Credit Facility, our unsecured senior credit facility, consists of a term loan facility for $150 million and a revolving credit facility for $165 million with a group of lenders (including and managed by JPMorgan Chase Bank, N.A.), and is guaranteed by certain of our U.S. subsidiaries.

We have letter-of-credit agreements with banks totaling approximately $6.7 million guaranteeing performance under various operating leases and vendor agreements.

In March 2006, we conducted a Phase I clinical trial on behalf of TeGenero AG, a German pharmaceutical company. During the trial, six participants experienced adverse reactions to the TeGenero compound being tested. In the first quarter of Fiscal Year 2010, we reached final settlement agreements with these participants. All amounts were paid by insurance companies.

We periodically become involved in various claims and lawsuits that are incidental to our business. We believe, after consultation with counsel, that no matters currently pending would, in the event of an adverse outcome, have a material impact on our consolidated financial position, results of operations, or liquidity.

OFF-BALANCE SHEET ARRANGEMENTS

We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to our investors.

INFLATION

We believe the effects of inflation generally do not have a material adverse impact on our operations or financial condition.

RECENTLY ISSUED ACCOUNTING STANDARDS

For a discussion of new accounting pronouncements, see Note 8 to our Condensed Consolidated Financial Statements included in this quarterly report on Form 10-Q.

 

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

MARKET RISK

Market risk is the potential loss arising from adverse changes in market rates and prices, such as foreign currency rates, interest rates, and other relevant market rates or price changes. In the ordinary course of business, we are exposed to market risk resulting from changes in foreign currency exchange rates, and we regularly evaluate our exposure to such changes. Our overall risk management strategy seeks to balance the magnitude of the exposure and the costs and availability of appropriate financial instruments.

FOREIGN CURRENCY EXCHANGE RATES AND INTEREST RATES

We derived approximately 66.0% of our consolidated service revenue for the three months ended September 30, 2009 from operations outside of the U.S., of which 26.3% was denominated in Euros and 13.1% was denominated in pounds sterling. We derived approximately 66.2% of our consolidated service revenue for the three months ended September 30, 2008 from operations outside of the U.S., of which 28.1% was denominated in Euros and 12.8% was denominated in pounds sterling. We do not have significant operations in countries in which the economy is considered to be highly inflationary. Our financial statements are denominated in U.S. dollars. Accordingly, changes in exchange rates between foreign currencies and the U.S. dollar will affect the translation of financial results into U.S. dollars for purposes of reporting our consolidated financial results.

It is our policy to mitigate the risks associated with fluctuations in foreign exchange rates and in market rates of interest. Accordingly, we have instituted foreign currency hedging programs and an interest rate swap program. See Note 12 to our Condensed Consolidated Financial Statements included in this quarterly report on Form 10-Q for more information on our hedging programs and interest rate swap program.

As of September 30, 2009, the programs with derivatives designated as hedging instruments under ASC 815 (formerly SFAS 133) were deemed effective and the notional values of the derivatives were approximately $330.6 million. Under certain circumstances, such as the occurrence of significant differences between actual cash receipts and forecasted cash receipts, the program could be deemed ineffective. In that event, the unrealized gains and losses related to these derivatives, and currently reported in accumulated other comprehensive income, would be recognized in earnings. As of September 30, 2009, the estimated amount that could be recognized in other income is a loss of approximately $5.1 million.

As of September 30, 2009, the notional value of derivatives that were not designated as hedging instruments under ASC 815 (formerly SFAS 133) was approximately $121.1 million. The potential change in the fair value of these foreign currency exchange contracts that would result from a hypothetical change of 10% in exchange rates would be approximately $12.0 million.

During the three months ended September 30, 2009 and 2008, we recorded foreign exchange gains of $2.2 million and $2.6 million, respectively. We acknowledge our exposure to additional foreign exchange risk as it relates to assets and liabilities that are not part of the economic hedge program, but quantification of this risk is difficult to assess at any given point in time.

Our exposure to interest rate changes relates primarily to the amount of our short-term and long-term debt. Short-term debt was $32.1 million at September 30, 2009 and $32.1 million at June 30, 2009. Long-term debt was $244.1 million and $247.1 million for the corresponding periods.

In connection with the borrowings under our 2008 Credit Facility, we entered into interest rate exchange agreements to swap, at specified intervals, the difference between fixed and variable interest amounts calculated by reference to an agreed-upon notional principal amount. The mark-to-market values of both the hedge instrument and underlying debt obligations are recorded as equal and offsetting amounts in other comprehensive income. We had interest rate exchange agreements with a notional amount of $150 million and $150 million at September 30, 2009 and at June 30, 2009, respectively.

 

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ITEM 4. CONTROLS AND PROCEDURES

EVALUATION OF DISCLOSURE CONTROLS AND PROCEDURES

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2009. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2009, our chief executive officer and chief financial officer concluded that, as of such date, PAREXEL’s disclosure controls and procedures were effective at the reasonable assurance level.

CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING

As described in our Management’s Report on Internal Control over Financial Reporting for Fiscal Year 2009 as presented in the 2009 10-K, our internal control over financial reporting was not effective as of June 30, 2009 as our management identified a material weakness due to insufficient controls associated with accounting for the ClinPhone business combination, specifically the adoption of an accounting policy for revenue recognition in accordance with U.S. GAAP for IVR sales contracts with multiple revenue elements and the determination of fair value of deferred revenue assumed in the business combination.

During the fiscal quarter ended September 30, 2009, we adopted a plan to remediate the material weakness that included:

 

   

Review and redesign of internal controls related to business combinations, with emphasis on conforming an acquired entity’s accounting policies with U.S. GAAP;

 

   

Early evaluation by our Internal Audit group of the internal control environment of the acquired entity, together with periodic reports to management on internal control challenges and progress;

 

   

Strengthening or supplementing technical resources to provide for the completion of purchase accounting for the acquired entity as quickly as possible after transaction closing to identify and clear technical issues on a timely basis

 

   

Accelerating the integration of the acquired entity on to PAREXEL standard financial systems and shared services; and

 

   

Enhanced oversight by senior financial management on the harmonization of accounting and financial policies of the acquired company with PAREXEL policies and processes.

We anticipate that the plan described above, when applied to business combination transactions, and the resulting improvements in controls are reasonably likely to sufficiently strengthen our internal control over financial reporting and address the related material weakness identified as of June 30, 2009. However, the institutionalization of the internal control processes requires repeatable process execution, and because certain of these additional controls necessarily involve business combination transactions, the successful execution of these controls is reliant on business combination transactions occurring and allowing for the assessment of the operating effectiveness of these remediations before management is able to definitively conclude that the material weakness has been fully remediated.

 

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PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

We periodically become involved in various claims and lawsuits that are incidental to our business. We believe, after consultation with counsel, that no matters currently pending would, in the event of an adverse outcome, have a material impact on our consolidated financial position, results of operations, or liquidity.

 

ITEM 1A. RISK FACTORS

In addition to other information in this report, the following risk factors should be considered carefully in evaluating our company and our business. These important factors could cause our actual results to differ from those indicated by forward-looking statements made in this report, including in the section of this report entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other forward-looking statements that we may make from time to time. If any of the following risks occur, our business, financial condition, or results of operations would likely suffer.

The following discussion includes five new or revised risk factors (“We face risks arising from the restructuring of our operations;” “Our business is subject to international economic, political, and other risks that could negatively affect our results of operations or financial position;” “Our operating results have fluctuated between quarters and years and may continue to fluctuate in the future, which could affect the price of our common stock;” “We may have substantial exposure to payment of personal injury claims and may not have adequate insurance to cover such claims;” and “Our indebtedness may limit cash flow available to invest in the ongoing needs of our business”) that reflect material developments subsequent to the discussion of risk factors included in the 2009 10-K.

Additional risks not currently known to us or other factors not perceived by us to present significant risk to our business at this time also may impair our business operations.

Risks Associated with our Business and Operations

The loss, modification, or delay of large or multiple contracts may negatively impact our financial performance.

Our clients generally can terminate their contracts with us upon 30 to 60 days’ notice or can delay the execution of services. The loss or delay of a large contract or the loss or delay of multiple contracts could adversely affect our operating results, possibly materially. We have in the past experienced contract cancellations, which have adversely affected our operating results, including cancellations of a late-phase contract during the first quarter of Fiscal Year 2008 and a late-phase contract during the second quarter of Fiscal Year 2007.

Clients terminate or delay their contracts for a variety of reasons, including:

 

   

failure of products being tested to satisfy safety requirements;

 

   

failure of products being tested to satisfy efficacy criteria;

 

   

products having unexpected or undesired clinical results;

 

   

client cost reductions as a result of budgetary limit or changing priorities;

 

   

client decisions to forego a particular study, perhaps for economic reasons;

 

   

merger or potential merger related activities involving the client;

 

   

insufficient patient enrollment in a study;

 

   

insufficient investigator recruitment;

 

   

clinical drug manufacturing problems resulting in shortages of the product;

 

   

product withdrawal following market launch; and

 

   

shut down of manufacturing facilities.

 

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The current economic environment may negatively impact our financial performance as a result of client defaults and other factors.

Our ability to attract and retain clients, invest in and grow our business and meet our financial obligations depends on our operating and financial performance, which, in turn, is subject to numerous factors. In addition to factors specific to our business, prevailing economic conditions and financial, business and other factors beyond our control can also affect us. We cannot anticipate all the ways in which the current economic climate and financial market conditions could adversely impact our business.

We are exposed to risks associated with reduced profitability and the potential financial instability of our clients, many of whom may be adversely affected by the volatile conditions in the financial markets, the economy in general and disruptions to the demand for healthcare services and pharmaceuticals. These conditions could cause clients to experience reduced profitability and/or cash flow problems that could lead them to modify, delay or cancel contracts with us, including contracts included in our current backlog.

Some of our clients do not generate revenue and rely upon equity and debt investments and other external sources of capital to meet their cash requirements. Due to the poor condition of the current global economy and other factors outside of our control, these clients may lack the funds necessary to meet outstanding liabilities to us, despite contractual obligations. For example, in the second quarter of Fiscal Year 2009, one of our small biopharma clients informed us that it had encountered funding difficulties when one of its major investors defaulted on a contractual investment commitment. As a result, we recorded approximately $15.0 million in reserves related to this late-stage trial, including $12.3 million in bad debt reserves. It is possible that similar situations could arise in the future. These defaults can negatively affect our financial performance, possibly materially.

We face risks arising from the restructuring of our operations.

In October 2009, we adopted a plan to restructure our operations to reduce expenses, better align costs with current and future geographic sources of revenue, and improve operating efficiencies. These actions are expected to result in a pre-tax charge of approximately $30 million in the quarter ending December 31, 2009. The charge is primarily related to expenses to be incurred in connection with the consolidation or closure of certain offices, the reduction of approximately 4% of our workforce, and certain other one-time costs. We anticipate that we will substantially complete these restructuring activities by June 30, 2010. The charges will include approximately $7 million in costs related to the abandonment of certain property leases, approximately $22 million in employee separation benefits, and approximately $1 million in other one-time costs. We expect a majority of the $30 million charge to be paid out in the second half of Fiscal Year 2010, with the remainder to be paid out over several years, in the form of cash expenditures. If we incur restructuring charges in addition to those charges that we currently expect to incur, our financial condition and results of operations may suffer.

Restructuring also presents significant potential risks of events occurring that could adversely affect us, including a decrease in employee morale, delays encountered in finalizing the scope of, and implementing, the restructurings (including extensive consultations concerning potential workforce reductions (particularly in locations outside of the U.S.)), the failure to achieve targeted cost savings and the failure to meet operational targets and customer requirements due to the loss of employees and any work stoppages that might occur. These risks are further complicated by our extensive international operations, which subject us to different legal and regulatory requirements that govern the extent, and the speed, of our ability to reduce our operating capacity and workforce.

The fixed rate nature of our contracts could hurt our operating results.

Approximately 90% of our contracts are fixed rate. If we fail to accurately price our contracts or if we experience significant cost overruns, our gross margins on the contracts would be reduced and we could lose money on contracts. In the past, we have had to commit unanticipated resources to complete projects, resulting in lower gross margins on those projects. We might experience similar situations in the future.

If we are unable to attract suitable willing investigators and volunteers for our clinical trials, our clinical development business might suffer.

The clinical research studies we run in our CRS segment rely upon the ready accessibility and willing participation of physician investigators and volunteer subjects. Investigators are typically located at hospitals, clinics or other sites and supervise administration of the study drug to patients during the course of a clinical trial. Volunteer subjects generally include people from the communities in which the studies are conducted. Our clinical research development business could be adversely affected if we were unable to attract suitable and willing investigators or volunteers on a consistent basis.

 

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If our Perceptive business is unable to maintain continuous, effective, reliable and secure operation of its computer hardware, software and internet applications and related tools and functions, its business will be harmed.

Our Perceptive business involves collecting, managing, manipulating and analyzing large amounts of data, and communicating data via the Internet. In our Perceptive business, we depend on the continuous, effective, reliable and secure operation of computer hardware, software, networks, telecommunication networks, Internet servers and related infrastructure. If the hardware or software malfunctions or access to data by internal research personnel or customers through the Internet is interrupted, our Perceptive business could suffer. In addition, any sustained disruption in Internet access provided by third parties could adversely impact our Perceptive business.

Although the computer and communications hardware used in our Perceptive business is protected through physical and software safeguards, it is still vulnerable to fire, storm, flood, power loss, earthquakes, telecommunications failures, physical or software break-ins, and similar events. And while certain of our operations have appropriate disaster recovery plans in place, we currently do not have redundant facilities everywhere in the world to provide IT capacity in the event of a system failure. In addition, the Perceptive software products are complex and sophisticated, and could contain data, design or software errors that could be difficult to detect and correct. If Perceptive fails to maintain and further develop the necessary computer capacity and data to support the needs of our Perceptive customers, it could result in a loss of or a delay in revenue and market acceptance. Additionally, significant delays in the planned delivery of system enhancements or inadequate performance of the systems once they are completed could damage our reputation and harm our business.

Finally, long-term disruptions in the infrastructure caused by events such as natural disasters, the outbreak of war, the escalation of hostilities, and acts of terrorism (particularly in areas where we have offices) could adversely affect our businesses. Although we carry property and business interruption insurance, our coverage may not be adequate to compensate us for all losses that may occur.

Our business is subject to international economic, political, and other risks that could negatively affect our results of operations or financial position.

We provide most of our services on a worldwide basis. Our service revenue from non-U.S. operations represented approximately 66.0% and 66.2% of total consolidated service revenue for the three months ended September 30, 2009 and 2008, respectively. More specifically, our service revenue from operations in Europe, Middle East and Africa represented 49.9% and 53.4% of total consolidated service revenue for the corresponding periods. Our service revenue from operations in the Asia/Pacific region represented 11.0% and 7.7% of total consolidated service revenue for the respective periods. Accordingly, our business is subject to risks associated with doing business internationally, including:

 

   

changes in a specific country’s or region’s political or economic conditions, including Western Europe, in particular;

 

   

potential negative consequences from changes in tax laws affecting our ability to repatriate profits;

 

   

difficulty in staffing and managing widespread operations;

 

   

unfavorable labor regulations applicable to our European or other international operations;

 

   

changes in foreign currency exchange rates;

 

   

the need to ensure compliance with the numerous regulatory and legal requirements applicable to our business in each of these jurisdictions and to maintain an effective compliance program to ensure compliance; and

 

   

longer payment cycles of foreign customers and difficulty of collecting receivables in foreign jurisdictions.

Our operating results are impacted by the health of the North American, European and Asian economies, among others. Our business and financial performance may be adversely affected by current and future economic conditions that cause a decline in business and consumer spending, including a reduction in the availability of credit, rising interest rates, financial market volatility and recession

If we cannot retain our highly qualified management and technical personnel, our business would be harmed.

We rely on the expertise of our Chairman and Chief Executive Officer, Josef H. von Rickenbach, and our Chief Operating Officer, Mark A. Goldberg, and it would be difficult and expensive to find qualified replacements with the level of specialized knowledge of our products and services and the biopharmaceutical services industry. While we are a party to an employment agreement with Mr. von Rickenbach it may be terminated by either party upon notice to the counterparty.

 

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In addition, in order to compete effectively, we must attract and retain qualified sales, professional, scientific, and technical operating personnel. Competition for these skilled personnel, particularly those with a medical degree, a Ph.D. or equivalent degrees, is intense. We may not be successful in attracting or retaining key personnel.

Risks Associated with our Financial Results

Our operating results have fluctuated between quarters and years and may continue to fluctuate in the future, which could affect the price of our common stock.

Our quarterly and annual operating results have varied and will continue to vary in the future as a result of a variety of factors. For example, our income from operations totaled $18.5 million for the fiscal quarter ended September 30, 2009, $19.5 million for the fiscal quarter ended June 30, 2009, $26.4 million for the fiscal quarter ended March 31, 2009, and $7.7 million for the fiscal quarter ended December 31, 2008. Factors that cause these variations include:

 

   

the level of new business authorizations in a particular quarter or year;

 

   

the timing of the initiation, progress, or cancellation of significant projects;

 

   

exchange rate fluctuations between quarters or years;

 

   

restructuring charges;

 

   

seasonality;

 

   

the mix of services offered in a particular quarter or year;

 

   

the timing of the opening of new offices or internal expansion;

 

   

timing, costs and the related financial impact of acquisitions;

 

   

the timing and amount of costs associated with integrating acquisitions;

 

   

the timing and amount of startup costs incurred in connection with the introduction of new products, services or subsidiaries

 

   

the dollar amount of changes in contract scope finalized during a particular period; and

 

   

the amount of any reserves we are required to record.

Many of these factors, such as the timing of cancellations of significant projects and exchange rate fluctuations between quarters or years, are beyond our control.

If our operating results do not match the expectations of securities analysts and investors, the trading price of our common stock will likely decrease.

Backlog may not result in revenue, and the rate at which this backlog converts into revenue may slow when compared to historical trends.

Our backlog is not necessarily a meaningful predictor of future results because backlog can be affected by a number of factors, including the size and duration of contracts, many of which are performed over several years. Additionally, as described above, contracts relating to our clinical development business are subject to early termination by the client and clinical trials can be delayed or canceled for many reasons, including unexpected test results, safety concerns, regulatory developments or economic issues. Also, the scope of a contract can be reduced significantly during the course of a study. If the scope of a contract is revised, the adjustment to backlog occurs when the revised scope is approved by the client. For these and other reasons, we do not fully realize all of our backlog as net revenue.

In addition, the rate at which our backlog converts into revenue may slow. A slowdown in this conversion rate means that the rate of revenue recognized on contract awards may be slower than what we have experienced in the past, which could impact our net revenue and results of operations on a quarterly and annual basis.

 

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Our revenue and earnings are exposed to exchange rate fluctuations, which has substantially affected our operating results.

We conduct a significant portion of our operations in foreign countries. Because our financial statements are denominated in U.S. dollars, changes in foreign currency exchange rates could have and have had a significant effect on our operating results. For example, as a result of year-over-year foreign currency fluctuation, service revenue for the three months ended September 30, 2009 was negatively impacted by approximately $16.2 million as compared with the same period in the previous year. Exchange rate fluctuations between local currencies and the U.S. dollar create risk in several ways, including:

 

   

Foreign Currency Translation Risk. The revenue and expenses of our foreign operations are generally denominated in local currencies, primarily the pound sterling and the Euro, and are translated into U.S. dollars for financial reporting purposes. For the three months ended September 30, 2009 and 2008, approximately 26.3% and 28.1% of consolidated service revenue was denominated in Euros, respectively. Revenue, denominated in pounds sterling, was 13.1% and 12.8%, respectively, for the same periods. Accordingly, changes in exchange rates between foreign currencies and the U.S. dollar will affect the translation of foreign results into U.S. dollars for purposes of reporting our consolidated results.

 

   

Foreign Currency Transaction Risk. We may be subjected to foreign currency transaction risk when our foreign subsidiaries enter into contracts or incur liabilities denominated in a currency other than the foreign subsidiaries functional (local) currency. To the extent we are unable to shift the effects of currency fluctuations to the clients, foreign exchange fluctuations as a result of foreign currency exchange losses could have a material adverse effect on our results of operations.

Although we try to limit these risks through exchange rate fluctuation provisions stated in our service contracts, or by hedging transaction risk with foreign currency exchange contracts, we do not succeed in all cases. Even in those cases where we are successful, we may still experience fluctuations in financial results from our operations outside of the U.S., and we may not be able to favorably reduce the currency transaction risk associated with our service contracts.

Our effective income tax rate may fluctuate from quarter-to-quarter, which may affect our earnings and earnings per share.

Our quarterly effective income tax rate is influenced by our projected profitability in the various taxing jurisdictions in which we operate. Changes in the distribution of profits and losses among taxing jurisdictions may have a significant impact on our effective income tax rate, which in turn could have a material adverse effect on our net income and earnings per share. Factors that affect the effective income tax rate include, but are not limited to:

 

   

the requirement to exclude from our quarterly worldwide effective income tax calculations losses in jurisdictions where no tax benefit can be recognized;

 

   

actual and projected full year pretax income;

 

   

changes in tax laws in various taxing jurisdictions;

 

   

audits by taxing authorities; and

 

   

the establishment of valuation allowances against deferred tax assets if it is determined that it is more likely than not that future tax benefits will not be realized.

Additionally, recently proposed changes to the U.S. international tax laws would limit U.S. deductions for expenses related to offshore earnings and modify the U.S. foreign tax credit and “check-the-box” rules. It is unclear whether these proposed tax reforms will be enacted or, if enacted, what the scope of the reforms will be. Any potential changes from this proposal or from the other factors described above could cause fluctuations in our effective income tax rate that could cause fluctuations in our earnings and earnings per share, which can affect our stock price.

Our results of operations may be adversely affected if we fail to realize the full value of our goodwill and intangible assets.

As of September 30, 2009, our total assets included $353.9 million of goodwill and net intangible assets. We assess the realizability of our net intangible assets and goodwill annually as well as whenever events or changes in circumstances indicate that these assets may be impaired. These events or circumstances generally include operating losses or a significant decline in earnings associated with the acquired business or asset. Our ability to realize the value of the goodwill and indefinite-lived intangible assets will depend on the future cash flows of these businesses. These cash flows in turn depend in part on how well we have integrated these businesses. If we are not able to realize the value of the goodwill and indefinite-lived intangible assets, we may be required to incur material charges relating to the impairment of those assets.

 

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Our business has experienced substantial expansion in the past and such expansion and any future expansion could strain our resources if not properly managed.

We have expanded our business substantially in the past. For example, in August 2008, we completed the acquisition of ClinPhone, a leading clinical technology organization, for a purchase price of approximately $190 million. Future rapid expansion could strain our operational, human and financial resources. In order to manage expansion, we must:

 

   

continue to improve operating, administrative, and information systems;

 

   

accurately predict future personnel and resource needs to meet client contract commitments;

 

   

track the progress of ongoing client projects; and

 

   

attract and retain qualified management, sales, professional, scientific and technical operating personnel.

If we do not take these actions and are not able to manage the expanded business, the expanded business may be less successful than anticipated, and we may be required to allocate additional resources to the expanded business, which we would have otherwise allocated to another part of our business.

If we are unable to successfully integrate an acquired company, the acquisition could lead to disruptions to our business. The success of an acquisition will depend upon, among other things, our ability to:

 

   

assimilate the operations and services or products of the acquired company;

 

   

integrate acquired personnel;

 

   

retain and motivate key employees;

 

   

retain customers;

 

   

identify and manage risks facing the acquired company; and

 

   

minimize the diversion of management’s attention from other business concerns.

Acquisitions of foreign companies may also involve additional risks, including assimilating differences in foreign business practices and overcoming language and cultural barriers.

In the event that the operations of an acquired business do not meet our performance expectations, we may have to restructure the acquired business or write-off the value of some or all of the assets of the acquired business.

Risks Associated with our Industry

We depend on the pharmaceutical and biotechnology industries, either or both of which may suffer in the short- or long-term.

Our revenues depend greatly on the expenditures made by the pharmaceutical and biotechnology industries in research and development. In some instances, companies in these industries are reliant on their ability to raise capital in order to fund their research and development projects. Accordingly, economic factors and industry trends that affect our clients in these industries also affect our business. If companies in these industries were to reduce the number of research and development projects they conduct or outsource, our business could be materially adversely affected.

In addition, we are dependent upon the ability and willingness of pharmaceutical and biotechnology companies to continue to spend on research and development and to outsource the services that we provide. We are therefore subject to risks, uncertainties and trends that affect companies in these industries. We have benefited to date from the tendency of pharmaceutical and biotechnology companies to outsource clinical research projects, but any downturn in these industries or reduction in spending or outsourcing could adversely affect our business. For example, if these companies expanded upon their in-house clinical or development capabilities, they would be less likely to utilize our services.

Because we depend on a small number of industries and clients for all of our business, the loss of business from a significant client could harm our business, revenue and financial condition.

The loss of, or a material reduction in the business of, a significant client could cause a substantial decrease in our revenue and adversely affect our business and financial condition, possibly materially. In Fiscal Years 2009, 2008, and 2007, our five

 

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largest clients accounted for approximately 28%, 31%, and 28% of our consolidated service revenue, respectively. We expect that a small number of clients will continue to represent a significant part of our consolidated revenue. Our contracts with these clients generally can be terminated on short notice. We have in the past experienced contract cancellations with significant clients.

We face intense competition in many areas of our business; if we do not compete effectively, our business will be harmed.

The biopharmaceutical services industry is highly competitive and we face numerous competitors in many areas of our business. If we fail to compete effectively, we may lose clients, which would cause our business to suffer.

We primarily compete against in-house departments of pharmaceutical companies, other full service clinical research organizations (“CROs”), small specialty CROs, and, to a lesser extent, universities, teaching hospitals, and other site organizations. Some of the larger CROs against which we compete include Quintiles Transnational Corporation, Covance, Inc., Pharmaceutical Product Development Inc., and Icon plc. In addition, our PCMS business competes with a large and fragmented group of specialty service providers, including advertising/promotional companies, major consulting firms with pharmaceutical industry groups and smaller companies with pharmaceutical industry focus. Perceptive competes primarily with CROs, information technology companies and other software companies. Some of these competitors, including the in-house departments of pharmaceutical companies, have greater capital, technical and other resources than we have. In addition, our competitors that are smaller specialized companies may compete effectively against us because of their concentrated size and focus.

In recent years, a number of the large pharmaceutical companies have established formal or informal alliances with one or more CROs relating to the provision of services for multiple trials over extended time periods. Our success depends in part on our successfully establishing and maintaining these relationships. If we fail to do so, our revenues and results of operations could be adversely affected, possibly materially.

If we do not keep pace with rapid technological changes, our products and services may become less competitive or obsolete, especially in our Perceptive business.

The biotechnology, pharmaceutical and medical device industries generally, and clinical research specifically, are subject to increasingly rapid technological changes. Our competitors or others might develop technologies, products or services that are more effective or commercially attractive than our current or future technologies, products or services, or render our technologies, products or services less competitive or obsolete. If our competitors introduce superior technologies, products or services and we cannot make enhancements to our technologies, products and services necessary to remain competitive, our competitive position would be harmed. If we are unable to compete successfully, we may lose clients or be unable to attract new clients, which could lead to a decrease in our revenue.

Risks Associated with Regulation or Legal Liabilities

If governmental regulation of the drug, medical device and biotechnology industry changes, the need for our services could decrease.

Governmental regulation of the drug, medical device and biotechnology product development process is complicated, extensive, and demanding. A large part of our business involves assisting pharmaceutical, biotechnology and medical device companies through the regulatory approval process. Changes in regulations, that, for example, streamline procedures or relax approval standards, could eliminate or reduce the need for our services. If companies regulated by the United States Food and Drug Administration (the “FDA”) or similar foreign regulatory authorities needed fewer of our services, we would have fewer business opportunities and our revenues would decrease, possibly materially.

In the United States, the FDA and the Congress have attempted to streamline the regulatory process by providing for industry user fees that fund the hiring of additional reviewers and better management of the regulatory review process. In Europe, governmental authorities have approved common standards for clinical testing of new drugs throughout the European Union by adopting standards for Good Clinical Practices (“GCP”) and by making the clinical trial application and approval process more uniform across member states. The FDA has had GCP in place as a regulatory standard and requirement for new drug approval for many years and Japan adopted GCP in 1998.

The United States, Europe and Japan have also collaborated for over 15 years on the International Conference on Harmonisation (“ICH”), the purpose of which is to eliminate duplicative or conflicting regulations in the three regions. The ICH partners have agreed upon a common format (the Common Technical Document) for new drug marketing applications that reduces the need to tailor the format to each region. Such efforts and similar efforts in the future that streamline the regulatory process may reduce the demand for our services.

 

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Parts of our PCMS business advise clients on how to satisfy regulatory standards for manufacturing and clinical processes and on other matters related to the enforcement of government regulations by the FDA and other regulatory bodies. Any reduction in levels of review of manufacturing or clinical processes or levels of regulatory enforcement, generally, would result in fewer business opportunities for our business in this area.

If we fail to comply with existing regulations, our reputation and operating results would be harmed.

Our business is subject to numerous governmental regulations, primarily relating to worldwide pharmaceutical and medical device product development and regulatory approval and the conduct of clinical trials. If we fail to comply with these governmental regulations, it could result in the termination of our ongoing research, development or sales and marketing projects, or the disqualification of data for submission to regulatory authorities. We also could be barred from providing clinical trial services in the future or could be subjected to fines. Any of these consequences would harm our reputation, our prospects for future work and our operating results. In addition, we may have to repeat research or redo trials. If we are required to repeat research or redo trials, we may be contractually required to do so at no further cost to our clients, but at substantial cost to us.

We may lose business opportunities as a result of health care reform and the expansion of managed-care organizations.

Numerous governments, including the U.S. government, have undertaken efforts to control growing health care costs through legislation, regulation and voluntary agreements with medical care providers and drug companies. In recent years, the U.S. Congress has reviewed several comprehensive health care reform proposals. The proposals are intended to expand health care coverage for the uninsured and reduce the growth of total health care expenditures. The U.S. Congress has also considered and may adopt legislation that could have the effect of putting downward pressure on the prices that pharmaceutical and biotechnology companies can charge for prescription drugs.

If these efforts are successful, drug, medical device and biotechnology companies may react by spending less on research and development. If this were to occur, we would have fewer business opportunities and our revenue could decrease, possibly materially. In addition, new laws or regulations may create a risk of liability, increase our costs or limit our service offerings.

In addition to health care reform proposals, the expansion of managed-care organizations in the health care market and managed-care organizations’ efforts to cut costs by limiting expenditures on pharmaceuticals and medical devices could result in pharmaceutical, biotechnology and medical device companies spending less on research and development. If this were to occur, we would have fewer business opportunities and our revenue could decrease, possibly materially.

We may have substantial exposure to payment of personal injury claims and may not have adequate insurance to cover such claims.

Our CRS business primarily involves the testing of experimental drugs and medical devices on consenting human volunteers pursuant to a study protocol. Clinical research involves a risk of liability for a number of reasons, including, but not limited to:

 

   

personal injury or death to patients who participate in the study or who use a product approved by regulatory authorities after the clinical research has concluded;

 

   

general risks associated with clinical pharmacology facilities, including professional malpractice of clinical pharmacology medical care providers; and

 

   

errors and omissions during a trial that may undermine the usefulness of a trial or data from the trial or study.

In order to mitigate the risk of liability, we seek to include indemnity provisions in our CRS contracts with clients and with investigators. However, we are not able to include indemnity provisions in all of our contracts. In addition, even if we are able to include an indemnity provision in our contracts, the indemnity provisions may not cover our exposure if:

 

   

we had to pay damages or incur defense costs in connection with a claim that is outside the scope of an indemnity agreement; or

 

   

a client failed to indemnify us in accordance with the terms of an indemnity agreement because it did not have the financial ability to fulfill its indemnification obligation or for any other reason.

In addition, contractual indemnifications generally do not protect us against liability arising from certain of our own actions, such as negligence or misconduct.

 

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We also carry insurance to cover our risk of liability. However, our insurance is subject to deductibles and coverage limits and may not be adequate to cover claims. In addition, liability coverage is expensive. In the future, we may not be able to maintain or obtain liability insurance on reasonable terms, at a reasonable cost, or in sufficient amounts to protect us against losses due to claims.

Existing and proposed laws and regulations regarding confidentiality of patients’ information could result in increased risks of liability or increased cost to us or could limit our product and service offerings.

The confidentiality, security, use and disclosure of patient-specific information are subject to governmental regulation. Regulations to protect the safety and privacy of human subjects who participate in or whose data are used in clinical research generally require clinical investigators to obtain affirmative informed consent from identifiable research subjects before research is undertaken. Under the Health Insurance Portability and Accountability Act of 1996, or HIPAA, the U.S. Department of Health and Human Services has issued regulations mandating privacy and security protections for certain types of individually identifiable health information, or protected health information, when used or disclosed by health care providers and other HIPAA-covered entities or business associates that provide services to or perform functions on behalf of these covered entities. HIPAA regulations require individuals’ written authorization before identifiable health information may be used for research, in addition to any required informed consent. HIPAA regulations also specify standards for de-identifying health information so that information can be handled outside of the HIPAA requirements and for creating limited data sets that can be used for research purposes under less stringent HIPAA restrictions. The European Union and its member states, as well as other countries, such as Japan, and state governments in the United States, have adopted and continue to issue new medical privacy and general data protection laws and regulations. In order to comply with these laws and regulations, we may need to implement new privacy and security measures, which may require us to make substantial expenditures or cause us to limit the products and services we offer. In addition, if we violate applicable laws, regulations, contractual commitments, or other duties relating to the use, privacy or security of health information, we could be subject to civil liability or criminal penalties and it may be necessary to modify our business practices.

Failure to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002, and delays in completing our internal controls and financial audits, could have a material adverse effect on our business and stock price.

Our Fiscal Year 2009 management assessment revealed a material weakness in our internal controls over financial reporting due to insufficient controls associated with accounting for the ClinPhone business combination, specifically the adoption by ClinPhone of an accounting policy for revenue recognition in accordance with U.S. GAAP for IVR sales contracts with multiple revenue elements and the determination of the fair value of deferred revenue assumed in the business combination. We are attempting to cure this material weakness, but we have not yet completed remediation and there can be no assurance that such remediation will be successful. During the course of our continued testing, we also may identify other significant deficiencies or material weaknesses, in addition to the ones already identified, which we may not be able to remediate in a timely manner or at all. If we continue to fail to achieve and maintain effective internal controls, we will not be able to conclude that we have effective internal controls over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002. Failure to achieve and maintain an effective internal control environment, and delays in completing our internal controls and financial audits, could cause investors to lose confidence in our reported financial information and us, which could result in a decline in the market price of our common stock, and cause us to fail to meet our reporting obligations in the future, which in turn could impact our ability to raise equity financing if needed in the future.

Risks Associated with Leverage

Our indebtedness may limit cash flow available to invest in the ongoing needs of our business.

As of September 30, 2009, we had approximately $271.0 million principal amount of debt outstanding and remaining borrowing availability of approximately $29.0 million under our revolving line of credit. We may incur additional debt in the future. Our leverage could have significant adverse consequences, including:

 

   

requiring us to dedicate a substantial portion of any cash flow from operations to the payment of interest on, and principal of, our debt, which will reduce the amounts available to fund working capital and capital expenditures, and for other general corporate purposes;

 

   

increasing our vulnerability to general adverse economic and industry conditions;

 

   

limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and

 

   

placing us at a competitive disadvantage compared to our competitors that have less debt.

 

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Under the terms of the credit facility we entered into in June 2008, which we refer to as the 2008 Credit Facility, interest rates are fixed based on market indices at the time of borrowing and, depending upon the interest mechanism selected by us, may float thereafter. Some of our other smaller credit facilities also bear interest at floating rates. As a result, the amount of interest payable by us on our borrowings may increase if market interest rates change.

We may not have sufficient funds or may be unable to arrange for additional financing to pay the amounts due under our existing or any future debt. In addition, a failure to comply with the covenants under our existing debt instruments could result in an event of default under those instruments. In the event of an acceleration of amounts due under our debt instruments as a result of an event of default, we may not have sufficient funds or may be unable to arrange for additional financing to repay our indebtedness or to make any accelerated payments.

In addition, the terms of the 2008 Credit Facility provide that upon the occurrence of a change in control, as defined in the credit facility agreement, all outstanding indebtedness under the facility would become due. This provision may delay or prevent a change in control that stockholders may consider desirable.

Moreover, the United States credit markets are currently experiencing an unprecedented contraction. As a result of the tightening credit markets, we may not be able to obtain additional financing on favorable terms, or at all. If one or more of the financial institutions that supports our $165 million revolving credit facility, which is part of our 2008 Credit Facility, fails we may not be able to find a replacement, which would negatively impact our ability to borrow the remaining funds available under the $165 million facility.

Moreover, the 2008 Credit Facility will expire in June 2013 and all unpaid principal and interest will become due at that time. The recent and ongoing turmoil in the credit markets could affect our ability to refinance the 2008 Credit Facility or further increase our funding costs.

Our existing debt instruments contain covenants that limit our flexibility and prevent us from taking certain actions.

The agreement in connection with our 2008 Credit Facility includes a number of significant restrictive covenants. These covenants could adversely affect us by limiting our ability to plan for or react to market conditions, meet our capital needs and execute our business strategy. These covenants, among other things, limit our ability and the ability of our restricted subsidiaries to:

 

   

incur additional debt;

 

   

make certain investments;

 

   

enter into certain types of transactions with affiliates;

 

   

make specified restricted payments; and

 

   

sell certain assets or merge with or into other companies.

These covenants may limit our operating and financial flexibility and limit our ability to respond to changes in our business or competitive activities. Our failure to comply with these covenants could result in an event of default, which, if not cured or waived, could result in our being required to repay these borrowings before their scheduled due date.

Risks Associated with our Common Stock

Our corporate governance structure, including provisions of our articles of organization, by-laws, shareholder rights plan, as well as Massachusetts law, may delay or prevent a change in control or management that stockholders may consider desirable.

Provisions of our articles of organization, by-laws and our shareholder rights plan, as well as provisions of Massachusetts law, may enable our management to resist acquisition of us by a third party, or may discourage a third party from acquiring us. These provisions include the following:

 

   

we have divided our board of directors into three classes that serve staggered three-year terms;

 

   

we are subject to Section 8.06 of the Massachusetts Business Corporation Law, which provides that directors may only be removed by stockholders for cause, vacancies in our board of directors may only be filled by a vote of our board of directors, and the number of directors may be fixed only by our board of directors;

 

   

we are subject to Chapter 110F of the Massachusetts General Laws, which may limit the ability of some interested stockholders to engage in business combinations with us;

 

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our stockholders are limited in their ability to call or introduce proposals at stockholder meetings; and

 

   

our shareholder rights plan would cause a proposed acquirer of 20% or more of our outstanding shares of common stock to suffer significant dilution.

These provisions could have the effect of delaying, deferring, or preventing a change in control of us or a change in our management that stockholders may consider favorable or beneficial. These provisions could also discourage proxy contests and make it more difficult for stockholders to elect directors and take other corporate actions. These provisions could also limit the price that investors might be willing to pay in the future for shares of our stock.

In addition, our board of directors may issue preferred stock in the future without stockholder approval. If our board of directors issues preferred stock, the rights of the holders of common stock would be subordinate to the rights of the holders of preferred stock. Our board of directors’ ability to issue the preferred stock could make it more difficult for a third party to acquire, or discourage a third party from acquiring, a majority of our stock.

Our stock price has been, and may in the future be volatile, which could lead to losses by investors.

The market price of our common stock has fluctuated widely in the past and may continue to do so in the future. On November 2, 2009, the closing sales price of our common stock on the Nasdaq Global Select Market was $12.34 per share. During the period from November 2, 2007 to November 2, 2009, our common stock traded at prices ranging from a high of $59.51 per share to a low of $6.11 per share. Investors in our common stock must be willing to bear the risk of such fluctuations in stock price and the risk that the value of an investment in our stock could decline.

Our stock price can be affected by quarter-to-quarter variations in a number of factors including, but not limited to:

 

   

operating results;

 

   

earnings estimates by analysts;

 

   

market conditions in our industry;

 

   

prospects of health care reform;

 

   

changes in government regulations;

 

   

general economic conditions, and

 

   

our effective income tax rate.

In addition, the stock market has from time to time experienced significant price and volume fluctuations that are not related to the operating performance of particular companies. These market fluctuations may adversely affect the market price of our common stock. Although our common stock has traded in the past at a relatively high price-earnings multiple, due in part to analysts’ expectations of earnings growth, the price of the stock could quickly and substantially decline as a result of even a relatively small shortfall in earnings from, or a change in, analysts’ expectations.

 

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ITEM 5. OTHER INFORMATION

On September 10, 2009, our board of directors adopted an amendment to our By-laws (the “Amendment”). The Amendment includes modifications to the notice requirements for a shareholder of the Company seeking to bring a nomination for a director or a proposal for other business before a meeting of the shareholders of the Company. In addition, the Amendment expands the information required to be provided by any shareholder who submits a nomination for election to our board of directors or a shareholder proposal for consideration at meetings of shareholders, including information about the shareholder’s holdings in securities of the Company, including derivatives and short positions and any hedging arrangements, and, as applicable, the proposed nominee’s holdings, as well as any other information about the shareholder that would be required to be disclosed in a proxy statement or similar filing with the Securities and Exchange Commission. For proposed director nominees, the notice is also required to include information about any relationships between the shareholder and the proposed nominee. The notice also must include certain representations as to whether the shareholder intends to conduct a proxy solicitation, in addition to whether the shareholder intends to attend the meeting to present the director nomination or proposal. The Amendment also clarifies that shareholders may appoint proxies by electronic means. The foregoing description of the Amendment is qualified in its entirety by reference to the full text of the Amendment, a copy of which is filed as Exhibit 3.1 to our Current Report on Form 8-K dated September 15, 2009. A copy of our complete Amended and Restated By-laws, as amended, including the provisions of the Amendment, is filed hereto as Exhibit 3.1 to this Quarterly Report on Form 10-Q.

 

ITEM 6. EXHIBITS

See the Exhibit Index on the page immediately preceding the exhibits for a list of exhibits filed as part of this quarterly report, which Exhibit Index is incorporated by this reference.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

    PAREXEL International Corporation
Date: November 6, 2009     By:   /S/    JOSEF H. VON RICKENBACH        
      Josef H. von Rickenbach
      Chairman of the Board and Chief Executive Officer
Date: November 6, 2009     By:   /S/    JAMES F. WINSCHEL, JR.        
      James F. Winschel, Jr.
      Senior Vice President and Chief Financial Officer

 

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EXHIBIT INDEX

 

Exhibit
Number

  

Description

  3.1    Amended and Restated By-laws, as amended
31.1    Principal executive officer certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2    Principal financial officer certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1    Principal executive officer certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2    Principal financial officer certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

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