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Pharmaceutical Product Development 10-Q 2007
Form 10-Q
Table of Contents

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 AND EXCHANGE ACT OF 1934.

For the quarterly period ended June 30, 2007.

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 0-27570

 


PHARMACEUTICAL PRODUCT DEVELOPMENT, INC.

(Exact name of registrant as specified in its charter)

 


 

North Carolina   56-1640186

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

929 North Front Street

Wilmington, North Carolina

(Address of principal executive offices)

28401

(Zip Code)

Registrant’s telephone number, including area code: (910) 251-0081

 


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 is a large accelerated filer, an accelerated filer or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.

Large accelerated filer   x    Accelerated filer  ¨    Non-accelerated filer  ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the 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: 118,731,162 shares of common stock, par value $0.05 per share, as of July 31, 2007.

 



Table of Contents

INDEX

 

     Page
Part I. FINANCIAL INFORMATION   
Item 1. Financial Statements   

Consolidated Condensed Statements of Operations for the Three and Six Months Ended June 30, 2006 and 2007 (unaudited)

   3

Consolidated Condensed Balance Sheets as of December 31, 2006 and June 30, 2007 (unaudited)

   4

Consolidated Condensed Statements of Cash Flows for the Six Months Ended June 30, 2006 and 2007 (unaudited)

   5

Notes to Consolidated Condensed Financial Statements (unaudited)

   6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations    17
Item 3. Quantitative and Qualitative Disclosures about Market Risk    31
Item 4. Controls and Procedures    32
Part II. OTHER INFORMATION   
Item 1. Legal Proceedings    33
Item 4. Submission of Matters to a Vote of Security Holders    33
Item 6. Exhibits    34
Signatures    35

 

2


Table of Contents

Part I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share data)

 

    

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
     2006    2007     2006    2007  

Net Revenue:

          

Development

   $ 278,890    $ 316,527     $ 536,639    $ 616,683  

Discovery Sciences

     4,550      4,500       23,499      8,883  

Reimbursed out-of-pockets

     25,513      28,943       48,184      56,656  
                              

Total net revenue

     308,953      349,970       608,322      682,222  
                              

Direct Costs:

          

Development

     140,022      157,515       268,439      309,430  

Discovery Sciences

     2,069      2,462       4,477      4,820  

Reimbursable out-of-pocket expenses

     25,513      28,943       48,184      56,656  
                              

Total direct costs

     167,604      188,920       321,100      370,906  
                              

Research and development expenses

     1,261      3,963       1,942      5,868  

Selling, general and administrative expenses

     79,649      82,149       152,617      157,887  

Depreciation

     11,286      13,765       22,309      26,273  

Amortization

     124      78       397      156  
                              

Total operating expenses

     259,924      288,875       498,365      561,090  
                              

Income from operations

     49,029      61,095       109,957      121,132  

Interest income, net

     3,192      4,151       6,302      8,788  

Other income (expense), net

     1,329      (136 )     1,178      (214 )
                              

Income before provision for income taxes

     53,550      65,110       117,437      129,706  

Provision for income taxes

     17,136      22,463       39,177      45,072  
                              

Net income

   $ 36,414    $ 42,647     $ 78,260    $ 84,634  
                              

Net income per common share:

          

Basic

   $ 0.31    $ 0.36     $ 0.67    $ 0.72  
                              

Diluted

   $ 0.31    $ 0.36     $ 0.66    $ 0.71  
                              

Dividends declared per common share

   $ 0.025    $ 0.03     $ 0.05    $ 0.06  
                              

Weighted average number of common shares outstanding:

          

Basic

     116,618      118,265       116,426      118,071  

Dilutive effect of stock options and restricted stock

     1,800      1,505       1,790      1,514  
                              

Diluted

     118,418      119,770       118,216      119,585  
                              

The accompanying notes are an integral part of these consolidated condensed financial statements.

 

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Table of Contents

PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED BALANCE SHEETS

(in thousands)

 

    

December 31,

2006

  

June 30,

2007

          (unaudited)
Assets      

Current assets:

     

Cash and cash equivalents

   $ 179,795    $ 107,710

Short-term investments

     255,876      295,427

Accounts receivable and unbilled services, net

     408,917      453,348

Income tax receivable

     510      299

Investigator advances

     13,490      15,066

Prepaid expenses and other current assets

     36,495      45,893

Deferred tax assets

     13,119      21,760
             

Total current assets

     908,202      939,503

Property and equipment, net

     323,539      350,338

Goodwill

     212,382      213,190

Investments

     22,478      19,965

Intangible assets

     2,014      1,858

Long-term deferred tax assets

     11,368      13,312

Other long-term assets

     1,582      3,365
             

Total assets

   $ 1,481,565    $ 1,541,531
             

Liabilities and Shareholders’ Equity

     

Current liabilities:

     

Accounts payable

   $ 15,235    $ 24,657

Payables to investigators

     43,717      52,721

Accrued income taxes

     16,560      23,229

Other accrued expenses

     149,027      137,633

Deferred tax liabilities

     86      98

Unearned income

     195,707      184,289

Current maturities of long-term debt and capital lease obligations

     75,159      69
             

Total current liabilities

     495,491      422,696

Accrued additional pension liability

     10,768      10,098

Deferred tax liabilities

     4,247      1,117

Deferred rent and other

     18,159      49,826
             

Total liabilities

     528,665      483,737

Shareholders’ equity:

     

Common stock

     5,881      5,928

Paid-in capital

     449,173      480,646

Retained earnings

     490,764      562,741

Accumulated other comprehensive income

     7,082      8,479
             

Total shareholders’ equity

     952,900      1,057,794
             

Total liabilities and shareholders’ equity

   $ 1,481,565    $ 1,541,531
             

The accompanying notes are an integral part of these consolidated condensed financial statements.

 

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Table of Contents

PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

    

Six Months Ended

June 30,

 
     2006     2007  

Cash flows from operating activities:

    

Net income

   $ 78,260     $ 84,634  

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

    

Depreciation and amortization

     22,706       26,429  

Stock compensation expense

     9,882       11,341  

Loss (gain) on disposal of assets, net

     1,370       (168 )

(Gain) loss on investments

     (782 )     38  

Provision (benefit) for doubtful accounts

     10       (358 )

(Benefit) provision for deferred income taxes

     (3,296 )     301  

Change in operating assets and liabilities, net of acquisitions

     (3,320 )     (37,590 )
                

Net cash provided by operating activities

     104,830       84,627  
                

Cash flows from investing activities:

    

Purchases of property and equipment

     (65,844 )     (57,429 )

Proceeds from sale of property and equipment

     15       1,536  

Purchases of available-for-sale investments

     (369,121 )     (177,038 )

Maturities and sales of available-for-sale investments

     246,915       136,913  

Purchase of note receivable

     (7,474 )     —    

Proceeds from investments

     1,482       743  

Purchases of investments

     (521 )     (1,467 )
                

Net cash used in investing activities

     (194,548 )     (96,742 )
                

Cash flows from financing activities:

    

Principal repayments of long-term debt

     (6,005 )     —    

Proceeds from construction loan

     22,127       —    

Repayment of construction loan

     —         (74,833 )

Proceeds from revolving credit facility

     —         24,986  

Repayment of revolving credit facility

     —         (24,986 )

Repayment of capital leases obligations

     (829 )     (256 )

Proceeds from exercise of stock options and employee stock purchase plan

     13,471       17,687  

Income tax benefit from exercise of stock options and disqualifying dispositions of stock

     3,208       2,861  

Cash dividends paid

     (5,847 )     (7,106 )
                

Net cash provided by (used in) financing activities

     26,125       (61,647 )
                

Effect of exchange rate changes on cash and cash equivalents

     2,479       1,677  
                

Net decrease in cash and cash equivalents

     (61,114 )     (72,085 )

Cash and cash equivalents, beginning of the period

     182,000       179,795  
                

Cash and cash equivalents, end of the period

   $ 120,886     $ 107,710  
                

The accompanying notes are an integral part of these consolidated condensed financial statements.

 

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Table of Contents

PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

1. SIGNIFICANT ACCOUNTING POLICIES

The significant accounting policies followed by Pharmaceutical Product Development, Inc. and its subsidiaries (collectively the “Company”) for interim financial reporting are consistent with the accounting policies followed for annual financial reporting. The Company prepared these unaudited consolidated condensed financial statements in accordance with Rule 10-01 of Regulation S-X and, in management’s opinion, has included all adjustments of a normal recurring nature necessary for a fair presentation. The accompanying consolidated condensed financial statements should be read in conjunction with the consolidated financial statements and notes thereto in the Company’s Annual Report on Form 10-K for the year ended December 31, 2006. The results of operations for the three-month and six-month periods ended June 30, 2007 are not necessarily indicative of the results to be expected for the full year or any other period. The amounts in the December 31, 2006 consolidated condensed balance sheet are derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2006.

Principles of consolidation

The accompanying unaudited consolidated condensed financial statements include the accounts and results of operations of the Company. All intercompany balances and transactions have been eliminated in consolidation.

Recent accounting pronouncements

In July 2006, the Financial Accounting Standards Board, or FASB, issued Interpretation No. 48, “Accounting for Uncertainty in Income Taxes – an interpretation of FASB Statement No. 109”, or FIN 48, which establishes a single model to address accounting for uncertainty in tax positions. FIN 48 prescribes a recognition threshold that a tax position is required to meet before being recognized in the financial statements and provides guidance on de-recognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition issues. FIN 48 is effective for fiscal years beginning after December 15, 2006, so the Company adopted FIN 48 as of January 1, 2007. The cumulative impact of applying the provisions of FIN 48 is an adjustment to the opening balance of retained earnings. See Note 8 for further details.

In September 2006, the FASB issued Statement of Financial Accounting Standards No. 157, “Fair Value Measurements”, or SFAS No. 157, which defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In addition, the statement establishes a framework for measuring fair value and expands disclosure about fair value measurements. SFAS No. 157 is effective for fiscal years beginning after November 15, 2007 and interim periods within those years. The Company is currently evaluating and has not determined the impact of the adoption of SFAS No. 157 on its financial condition or results of operations.

In September 2006, the FASB issued SFAS No. 158, “Employers’ Accounting for Defined Benefit Pension and Other Postretirement Plans – an amendment of FASB Statements No. 87, 88, 106, and 132(R)”, or SFAS No. 158. This standard requires employers to recognize the underfunded or overfunded status of a defined benefit postretirement plan as an asset or liability in its statement of financial position and to recognize changes in the funded status in the year in which the changes occur through accumulated other comprehensive income. Additionally, SFAS No. 158 requires employers to measure the funded status of a plan as of the date of its year-end statement of financial position. The recognition of an asset and liability related to the funded status of a plan and the new disclosure provisions of SFAS No. 158 are effective for fiscal years ending after December 15, 2006. The Company currently uses a measurement date of November 30 and will be required to change the measurement date to December 31 for the year ended December 31, 2008. The Company adopted the recognition and disclosure provisions of SFAS No. 158 as of December 31, 2006.

 

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Table of Contents

PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

1. SIGNIFICANT ACCOUNTING POLICIES (continued)

 

Recent accounting pronouncements (continued)

In February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities – Including an amendment of FASB Statement No. 115”, or SFAS No. 159. This standard permits, but does not require, all entities to choose to measure eligible items at fair value at specified election dates. For items for which the fair value option has been elected, an entity would report unrealized gains and losses in earnings at each subsequent reporting date. SFAS No. 159 is effective as of the beginning of an entity’s first fiscal year beginning after November 15, 2007. The Company is currently evaluating and has not determined the impact of the adoption of SFAS No. 159 on its financial condition or results of operations.

In June 2007, the FASB reached a consensus on EITF Issue No. 06-11, “Accounting for Income Tax Benefits of Dividends on Share-Based Payment Awards”. EITF 06-11 requires companies to recognize as an increase to additional paid-in capital the income tax benefit realized from dividends or dividend equivalents that are charged to retained earnings and paid to employees for nonvested equity-classified employee share-based payment awards. EITF 06-11 is effective for fiscal years beginning after December 15, 2007. The Company does not expect EITF 06-11 will have a material impact on its financial condition or results of operations.

In June 2007, the FASB reached a consensus on EITF Issue No. 07-03, “Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities”. EITF 07-03 requires companies to defer and capitalize, until the goods have been delivered or the related services have been rendered, non-refundable advance payments for goods that will be used or services that will be performed in future research and development activities. EITF 07-03 is effective for fiscal years beginning after December 15, 2007. The Company does not expect EITF 07-03 will have a material impact on its financial condition or results of operations.

Earnings per share

The Company computes basic income per share information based on the weighted average number of common shares outstanding during the period. The Company computes diluted income per share information based on the weighted average number of common shares outstanding during the period plus the effects of any dilutive common stock equivalents. The Company excluded 58,500 shares and 167,400 shares from the calculation of earnings per diluted share during the three months ended June 30, 2006 and 2007, respectively, and 1,388,000 shares and 1,291,800 shares from the calculation of earnings per diluted share during the six months ended June 30, 2006 and 2007, respectively, because they were antidilutive.

Stock-Based Compensation

The Company accounts for its share-based compensation plans using the provisions of SFAS No. 123 (revised), “Share-Based Payment”. Accordingly, the Company measures stock-based compensation cost at grant date, based on the fair value of the award, and recognizes it as expense over the employee’s requisite service period.

During the six months ended June 30, 2007, the Company granted approximately 1,323,000 options with a weighted-average exercise price of $33.80. This amount includes approximately 1,075,000 shares granted in the Company’s annual grant on February 21, 2007. All options were granted with an exercise price equal to the fair value of the Company’s common stock on the grant date. The fair value of the Company’s common stock on the grant date is equal to the Nasdaq closing price of the Company’s stock on the date of grant, except for shares granted under the U.K. Subplan where the fair value of the Company’s common stock on the grant date is equal to the average of the high and low price of the Company’s common stock on the date of grant as reported by Nasdaq. The weighted-average grant date fair value per share and the aggregate fair value of options granted during the six months ended June 30, 2007 was $10.80 and $14.3 million, respectively. As of June 30, 2007, the Company had 6.4 million options outstanding.

 

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Table of Contents

PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

1. SIGNIFICANT ACCOUNTING POLICIES (continued)

 

Use of estimates in the preparation of financial statements

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

2. ACCOUNTS RECEIVABLE AND UNBILLED SERVICES

Accounts receivable and unbilled services consisted of the following amounts on the dates set forth below:

 

(in thousands)

   December 31,
2006
    June 30,
2007
 

Billed

   $ 273,941     $ 274,393  

Unbilled

     141,423       184,514  

Provision for doubtful accounts

     (6,447 )     (5,559 )
                

Total accounts receivable and unbilled services, net

   $ 408,917     $ 453,348  
                

 

3. PROPERTY AND EQUIPMENT

Property and equipment, stated at cost, consisted of the following amounts on the dates set forth below:

 

(in thousands)

  

December 31,

2006

   

June 30,

2007

 

Land

   $ 6,987     $ 7,045  

Buildings and leasehold improvements

     87,106       200,853  

Construction in progress

     114,810       20,040  

Furniture and equipment

     170,230       192,060  

Computer equipment and software

     143,313       153,718  
                

Total property and equipment

     522,446       573,716  

Less accumulated depreciation and amortization

     (198,907 )     (223,378 )
                

Total property and equipment, net

   $ 323,539     $ 350,338  
                

Capitalized costs for the new corporate headquarters facility in Wilmington, North Carolina, included in construction in progress as of December 31, 2006 and June 30, 2007, were $104.5 million and $4.0 million, respectively. During the six months ended June 30, 2007, the Company capitalized $122.2 million as it occupied the new corporate headquarters building and related parking facility. During the three months ended June 30, 2006 and 2007, the Company capitalized interest of approximately $0.5 million and $0.2 million, respectively, relating to the construction of the facility. During the six months ended June 30, 2006 and 2007, the Company capitalized interest of approximately $0.7 million and $1.4 million, respectively, relating to the construction of the facility.

The Company owned a building in Kersewell, Scotland, with a net book value of $1.3 million as of December 31, 2006. The Company classified this building as available for sale and included it in prepaid expenses and other current assets on the consolidated condensed balance sheet as of December 31, 2006. This building housed employees performing work in the Development segment of the Company. In January 2007, the Company sold this building for approximately $1.4 million, resulting in a gain of $0.1 million included in selling, general and administrative expenses on the Company’s consolidated condensed statements of operations.

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

3. PROPERTY AND EQUIPMENT (continued)

 

Property and equipment under capital leases, stated at cost, consisted of the following amounts on the dates set forth below:

 

(in thousands)

  

December 31,

2006

   

June 30,

2007

 

Leasehold improvements

   $ 824     $ 824  

Computer equipment and software

     656       656  

Furniture and equipment

     1,976       1,976  
                

Total property and equipment under capital leases

     3,456       3,456  

Less accumulated depreciation and amortization

     (2,139 )     (2,722 )
                

Total property and equipment under capital leases, net

   $ 1,317     $ 734  
                

 

4. GOODWILL AND INTANGIBLE ASSETS

Changes in the carrying amount of goodwill for the twelve months ended December 31, 2006 and the six months ended June 30, 2007, by operating segment, were as follows:

 

(in thousands)

   Development    Discovery
Sciences
   Total

Balance as of January 1, 2006

   $ 155,267    $ 53,616    $ 208,883

Translation adjustments

     3,499      —        3,499
                    

Balance as of December 31, 2006

     158,766      53,616      212,382

Translation adjustments

     808      —        808
                    

Balance as of June 30, 2007

     $159,574      $53,616      $213,190
                    

Information regarding the Company’s other intangible assets follows:

 

      December 31, 2006    June 30, 2007

(in thousands)

  

Carrying

Amount

  

Accumulated

Amortization

   Net   

Carrying

Amount

  

Accumulated

Amortization

   Net

Backlog and customer relationships

   $ 543    $ 447    $ 96    $ 543    $ 479    $ 64

License and royalty agreements

     4,500      2,582      1,918      4,500      2,706      1,794
                                         

Total

   $ 5,043    $ 3,029    $ 2,014    $ 5,043    $ 3,185    $ 1,858
                                         

The Company amortizes all intangible assets on a straight-line basis, based on estimated useful lives of three to five years for backlog and customer relationships, and ten years for license and royalty agreements. The weighted average amortization period is 5.0 years for backlog and customer relationships, 10.0 years for license and royalty agreements, and 9.5 years for all intangibles collectively.

Amortization expense for the three months ended June 30, 2006 and 2007 was $0.1 million for both periods. Amortization expense for the six months ended June 30, 2006 and 2007 was $0.4 million and $0.2 million, respectively. As of June 30, 2007, estimated amortization expense for each of the next five years was as follows:

 

(in thousands)

    

2007 (remaining 6 months)

   $ 156

2008

     283

2009

     250

2010

     250

2011

     250

2012

     250

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

5. SHORT-TERM INVESTMENTS AND INVESTMENTS

 

Short-term investments, which are composed of available-for-sale securities, and investments consisted of the following amounts on the dates set forth below:

 

(in thousands)

  

December 31,

2006

  

June 30,

2007

Short-term investments:

     

Auction Rate Securities

   $ 133,700    $ 159,800

Other municipal debt securities

     114,524      125,239

Other debt securities

     4,165      6,014

Preferred stock

     3,487      4,374
             

Total short-term investments

   $ 255,876    $ 295,427
             

Investments:

     

Cost-basis investments:

     

Bay City Capital Fund IV, L.P.

   $ 3,200    $ 4,311

A.M. Pappas Life Science Ventures III, L.P.

     1,188      1,173

Other investments

     750      750
             

Total cost-basis investments

     5,138      6,234

Marketable equity securities:

     

BioDelivery Sciences International, Inc.

     2,394      2,714

Accentia Biopharmaceuticals, Inc.

     14,946      11,017
             

Total marketable equity securities

     17,340      13,731
             

Total investments

   $ 22,478    $ 19,965
             

Short-term investments

As of December 31, 2006, the Company had short-term investments in Auction Rate Securities, or ARS, various other debt securities and preferred stock. The Company accounts for its investment in marketable securities in accordance with SFAS No. 115, “Accounting for Certain Investments in Debt and Equity Securities”. The Company’s short-term investments are classified as available-for-sale securities due to management’s intent regarding these securities. The Company determines realized and unrealized gains and losses on short-term investments on a specific identification basis. As of December 31, 2006, the Company had unrealized gains of $0.2 million and unrealized losses of $0.3 million associated with its investments in other municipal debt securities.

As of June 30, 2007, the Company had short-term investments in ARS, various other debt securities and preferred stock. As of June 30, 2007, the Company had unrealized gains of $0 and unrealized losses of $0.7 million associated with its investments in other municipal debt securities. There were no gross realized gains or losses on any of the Company’s short-term securities in the three or six months ended June 30, 2006 and 2007.

The estimated fair value of short-term investment securities at June 30, 2007, by contractual maturity, were as follows:

 

(in thousands)

    

Due in 1 year or less

   $ 63,843

Due in 1-5 years

     60,161

Due in 5-10 years

     7,703

Due after 10 years

     163,720
      
   $ 295,427
      

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

5. SHORT-TERM INVESTMENTS AND INVESTMENTS (continued)

 

Investments

The Company has equity investments in publicly traded entities. The Company classifies investments in marketable equity securities as available-for-sale securities and measures them at market value. The Company determines realized and unrealized gains and losses on equity investments in publicly traded entities on a specific identification basis. The Company records net unrealized gains or losses associated with investments in publicly traded entities as a component of shareholders’ equity until they are realized or an other-than-temporary decline has occurred. The market value of the Company’s equity investments in publicly traded entities is based on the closing price as quoted by the applicable stock exchange or market on the last day of the reporting period. The Company’s equity investments in publicly traded companies are classified as long-term assets due to the Company’s ability to hold its investments long-term, the strategic nature of the investments and the lack of liquidity in the public markets for these securities. As of December 31, 2006 and June 30, 2007, gross unrealized gains on investments in marketable securities were $0.7 million and $1.2 million, respectively. As of December 31, 2006 and June 30, 2007, gross unrealized losses on investments in marketable securities were $0 and $3.7 million, respectively.

The unrealized loss of $3.7 million as of June 30, 2007 related to the Company’s investment in 4.3 million shares of Accentia Biopharmaceuticals, Inc. common stock. The Company owned approximately 11.7% of Accentia’s outstanding common stock as of June 30, 2007. The security has been in a loss position for less than four months. Based upon review of Accentia’s financial position and the Company’s ability and intent to hold its investment for a period of time sufficient for a forecasted recovery of fair value, the Company did not consider this to be an other-than temporary impairment at June 30, 2007.

In June 2002, the Company purchased approximately 0.7 million units of BioDelivery Sciences International, Inc. Each unit consisted of one share of common stock and one warrant for common stock. In June 2007, the Company sold all 0.7 million of its outstanding warrants at various prices for total proceeds of $0.1 million, resulting in a loss of $0.2 million. In addition, the Company sold 67,924 shares of common stock in BioDelivery Sciences International for total proceeds of $0.3 million, resulting in a gain of $0.1 million. The Company owned approximately 3.3% of BioDelivery Sciences International’s outstanding common stock as of June 30, 2007.

The Company also has investments in privately held entities in the form of equity and convertible debt instruments that are not publicly traded and for which fair values are not readily determinable. The Company records all of its investments in private entities under the cost method of accounting. The Company determines realized and unrealized gains and losses on a specific identification basis. The Company assesses the net realizable value of these entities on a quarterly basis to determine if there has been a decline in the fair value of these entities, and if so, if the decline is other-than-temporary. This quarterly review includes an evaluation of the entity, including, among other things, the market condition of its overall industry, historical and projected financial performance, expected cash needs, and recent funding events, as well as the Company’s expected holding period and the length of time and the extent to which the fair value of the investment has been less than cost. This impairment analysis requires significant judgment.

In September 2005, the Company became a limited partner in Bay City Capital Fund IV, L.P., a venture capital fund established in July 2004 for the purpose of investing in life sciences companies. The Company has committed to invest up to a maximum of $10.0 million in this fund. Aggregate capital calls through June 30, 2007 totaled $4.3 million. Because no capital call can exceed 20% of the Company’s aggregate capital commitment, the Company anticipates its remaining capital commitment of $5.7 million will be made through a series of future capital calls over the next two years. The Company owned approximately 2.9% of the Bay City Fund IV as of June 30, 2007. The Company’s capital commitment will expire in June 2009.

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

5. SHORT-TERM INVESTMENTS AND INVESTMENTS (continued)

 

In May 2007, the Company became a limited partner in Bay City Capital Fund V, L.P., a venture capital fund established for the purpose of investing in life sciences companies. The Company has committed to invest up to a maximum of $10.0 million in this fund. As of June 30, 2007, there have not been any capital calls. Because no capital call can exceed 20% of the Company’s aggregate capital commitment, the Company anticipates its capital commitment will be made through a series of future capital calls over the term of its commitment. The Company’s capital commitment will expire on the fifth anniversary of the initial capital call.

In November 2003, the Company became a limited partner in A. M. Pappas Life Science Ventures III, L.P., a venture capital fund established for the purpose of making investments in equity securities of privately held companies in the life sciences, healthcare and technology industries. The Company has committed to invest up to a maximum of $4.8 million in this fund. Aggregate capital calls through June 30, 2007 were $1.5 million. In January 2007, the Pappas Fund made a cash distribution to its owners of which the Company’s portion was approximately $0.4 million. Because no capital call can exceed 10% of the Company’s aggregate capital commitment, the Company anticipates that its remaining capital commitment of $3.3 million will be made through a series of future capital calls over the next two years. The Company owned approximately 4.7% of the Pappas Fund as of June 30, 2007. The Company’s capital commitment will expire in May 2009.

 

6. COMPREHENSIVE INCOME

Comprehensive income consisted of the following amounts on the dates set forth below:

 

     

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 

(in thousands)

   2006     2007     2006     2007  

Net income, as reported

   $ 36,414     $ 42,647     $ 78,260     $ 84,634  

Other comprehensive (loss) income

        

Cumulative translation adjustment

     3,718       2,630       5,040       3,805  

Change in fair value of hedging transaction, net of taxes of $41, $0, $140 and $0, respectively

     96       —         327       —    

Reclassification adjustment for hedging results included in direct costs, net of taxes of $56, $0, $88 and $0, respectively

     133       —         206       —    

Unrealized loss on investments, net of taxes of ($3,611), ($1,457), ($1,218), and ($1,365), respectively

     (7,864 )     (2,616 )     (3,790 )     (2,408 )

Reclassification adjustment for gain realized included in other income

     (782 )     —         (782 )     —    
                                

Total other comprehensive (loss) income

     (4,699 )     14       1,001       1,397  
                                

Comprehensive income

   $ 31,715     $ 42,661     $ 79,261     $ 86,031  
                                

Accumulated other comprehensive income consisted of the following amounts on the dates set forth below:

 

(in thousands)

  

December 31,

2006

   

June 30,

2007

 

Translation adjustment

   $ 14,487     $ 18,292  

Pension liability, net of tax of ($3,326)

     (7,762 )     (7,762 )

Net unrealized gain (loss) on investments, net of taxes of $244 and ($1,121), respectively

     357       (2,051 )
                

Total

   $ 7,082     $ 8,479  
                

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

7. LONG-TERM DEBT

Long-term debt consisted of the following amounts on the dates set forth below:

 

(in thousands)

  

December 31,

2006

   

June 30,

2007

 

Construction loan facility, effective rate of 5.92%

   $ 74,833     $ —    

Capital leases at interest rates up to 9.57%

     326       69  
                
     75,159       69  

Less: current maturities

     (75,159 )     (69 )
                
   $ —       $ —    
                

In February 2006, the Company entered into an $80.0 million construction loan facility with Bank of America, N.A. Borrowings under this credit facility were used to finance the construction of the Company’s new corporate headquarters building and related parking facility in Wilmington, North Carolina, and bore interest at an annual fluctuating rate equal to the one-month London Interbank Offered Rate, or LIBOR, plus a margin of 0.6%. Interest on amounts borrowed under this construction loan facility was payable quarterly. The credit facility was scheduled to mature in February 2008, but during the six months ended June 30, 2007, the Company repaid all outstanding borrowings, totaling $74.8 million, under this facility.

Effective July 1, 2007, the Company renewed its $50.0 million revolving line of credit facility with Bank of America, N.A. Indebtedness under the facility is unsecured and subject to covenants relating to financial ratios and restrictions on certain types of transactions. This revolving credit facility does not expressly restrict or limit the payment of dividends. The Company was in compliance with all loan covenants as of June 30, 2007. Outstanding borrowings under the facility bear interest at an annual fluctuating rate equal to the one-month LIBOR plus a margin of 0.6%. Borrowings under this credit facility are available to provide working capital and for general corporate purposes. This credit facility is currently scheduled to expire in June 2008, at which time any outstanding balance will be due. As of June 30, 2007, no borrowings were outstanding under this credit facility, although the aggregate amount available for borrowing had been reduced by $1.2 million due to outstanding letters of credit issued under this facility.

 

8. INCOME TAXES

The Company adopted the provisions of FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes – an interpretation of FASB Statement No. 109”, or FIN 48, on January 1, 2007. As of December 31, 2006, the Company had recorded a contingent tax liability of $9.1 million. As a result of the implementation of FIN 48, the Company reclassified $8.2 million of this liability to non-current liabilities and recognized an increase in this non-current liability of $22.8 million. This increase was accounted for as a $5.6 million decrease in retained earnings, a $15.9 million increase in deferred tax assets, and a $1.3 million increase in long-term assets as of January 1, 2007. The non-current liabilities are included in deferred rent and other and the non-current assets are included in other long-term assets on the Company’s consolidated condensed balance sheet.

The Company had gross unrecognized tax benefits of approximately $28.2 million as of January 1, 2007. Of this total, $11.6 million, net of the federal benefit on state taxes, is the amount that, if recognized, would result in a reduction of the Company’s effective tax rate. The Company does not anticipate a significant change in total unrecognized tax benefits or the Company’s effective tax rate due to the settlement of audits and the expiration of statute of limitations within the next 12 months.

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

8. INCOME TAXES (continued)

 

The Company’s policy for recording interest and penalties associated with tax audits is to record them as a component of provision for income taxes. In conjunction with the adoption of FIN 48, the Company recognized approximately $4.0 million for the payment of interest and penalties at January 1, 2007. To the extent interest and penalties are not assessed with respect to uncertain tax positions, amounts accrued will be reduced and reflected as a reduction of the overall income tax provision.

The Company has analyzed filing positions in all of the significant federal, state and foreign jurisdictions where it is required to file income tax returns, as well as open tax years in these jurisdictions. The only periods subject to examination by the major tax jurisdictions where the Company does business are the 2003 through 2006 tax years. Various foreign income tax returns are under examination by taxing authorities. The Company does not believe that the outcome of any examination will have a material impact on its financial condition or results of operations.

 

9. PENSION PLAN

The Company determines pension costs under the provisions of SFAS No. 87, “Employers’ Accounting for Pensions” and related disclosures are determined under the provisions of SFAS No. 132 (revised 2003), “Employers’ Disclosures about Pensions and other Postretirement Benefits” as modified by SFAS No. 158.

The Company has a separate contributory defined benefit plan for its qualifying United Kingdom employees employed by the Company’s U.K. subsidiaries. This pension plan was closed to new participants as of December 31, 2002. The benefits for the U.K. Plan are based primarily on years of service and average pay at retirement. Plan assets consist principally of investments managed in a mixed fund.

Pension costs for the U.K. Plan included the following components:

 

      Three Months Ended
June 30,
    Six Months Ended
June 30,
 

(in thousands)

   2006     2007     2006     2007  

Service cost

   $ 442     $ 423     $ 866     $ 840  

Interest cost

     552       653       1,081       1,296  

Expected return on plan assets

     (506 )     (679 )     (991 )     (1,348 )

Amortization of net loss

     181       137       355       272  
                                

Net periodic pension cost

   $ 669     $ 534     $ 1,311     $ 1,060  
                                

For the six months ended June 30, 2007, the Company made contributions totaling $2.0 million and it anticipates contributing an additional $0.5 million to fund this plan during the remainder of 2007.

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

10. COMMITMENTS AND CONTINGENCIES

The Company currently maintains insurance for risks associated with the operation of its business, provision of professional services, and ownership of property. These policies provide coverage for a variety of potential losses, including loss or damage to property, bodily injury, general commercial liability, professional errors and omissions, and medical malpractice. The Company’s retentions and deductibles associated with these insurance policies range from $0.25 million to $2.5 million.

The Company is self-insured for health insurance for the majority of its employees located within the United States, but maintains stop-loss insurance on a “claims made” basis for expenses in excess of $0.28 million per member per year. As of December 31, 2006 and June 30, 2007, the Company maintained a reserve of approximately $7.4 million and $5.0 million, respectively, included in other accrued expenses on the consolidated condensed balance sheets, to cover open claims and estimated claims incurred but not reported.

The Company has commitments to invest an aggregate additional $19.0 million in three venture capital funds. For further details, see Note 5.

The Company has been involved in compound development and commercialization collaborations since 1997. The Company developed a risk-sharing research and development model to help pharmaceutical and biotechnology clients develop compounds. Through collaboration arrangements based on this model, the Company assists its clients by sharing the risks and potential rewards associated with the development and commercialization of drugs at various stages of development. As of June 30, 2007, the Company had four such arrangements that involve the potential future receipt of one or more of the following: payments upon the achievement of development and regulatory milestones; royalty payments if the compound is approved for sale; sales-based milestone payments; and a share of net sales up to a specified dollar limit. The compounds that are the subject of these collaborations are still in development and have not been approved for sale in any country.

The Company’s collaboration with ALZA Corporation, a subsidiary of Johnson & Johnson, for dapoxetine requires the Company to pay a royalty to Eli Lilly & Company of 5% on annual net sales of the compound in excess of $800 million. ALZA received a “not approvable” letter from the FDA in October 2005, but has continued its global development program and has said that it intends to file a marketing application for dapoxetine in Europe in late 2007 and is evaluating the possibility of a filing in Canada. As a result of the risks associated with drug development, including obtaining regulatory approval to sell in any country, the receipt of any further milestone payments, royalties or other payments with respect to any of the Company’s drug development collaborations is uncertain.

In February 2007, the Company exercised an option to license from Ranbaxy Laboratories Ltd. a statin compound that the Company intends to develop as a treatment for dyslipidemia, a metabolic disorder often characterized by high cholesterol levels. The option was exercised pursuant to an agreement entered into effective as of December 15, 2006. Upon exercise of the option, the Company paid a one-time license fee of $0.25 million. Under the agreement, the Company has an exclusive license to make, use, sell, import and sublicense the compound and any licensed product anywhere in the world for any human use. Ranbaxy retained a non-exclusive right to co-market licensed products in India and generic equivalents in any country in the world in which a third party has sold the generic equivalent of a licensed product. The Company is solely responsible, and will bear all costs and expenses, for the development, manufacture, marketing and commercialization of the compound and licensed products. In addition to the one-time license fee, the Company is obligated to pay Ranbaxy milestone payments upon the occurrence of specified clinical development events. If a licensed product is approved for sale, the Company must also pay Ranbaxy royalties based on sales of the product, as well as commercial milestone payments based on the achievement of specified worldwide sales targets. If all criteria are met, the total amount of potential clinical and sales-based milestones would be $44.0 million. The Company filed the investigational new drug application, or IND, for the statin compound in late March 2007. The Company completed a single ascending dose, first-in-human study for this statin in June 2007, and the compound was safe and well tolerated at all doses in this trial. The Company recently commenced a first-in-patient study and plans to proceed into a Phase II proof-of-concept study in the fourth quarter of 2007. In addition, the Company initiated a drug-drug interaction study to determine if there is any interaction between the Company’s statin and gemfibrozil, a fibrate commonly used to lower triglycerides.

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

10. COMMITMENTS AND CONTINGENCIES (continued)

 

Under most of its agreements for Development services, the Company agrees to indemnify and defend the sponsor against third-party claims based on the Company’s negligence or willful misconduct. Any successful claims could have a material adverse effect on the Company’s financial condition, results of operations and future prospects.

In the normal course of business, the Company is a party to various claims and legal proceedings, including claims for alleged breaches of contract. In one proceeding against the Company, a former client claimed the Company breached its contract and committed tortious acts in conducting a clinical trial. That former client claimed that it did not owe the Company the remaining amounts due under the contract and sought other damages from the Company’s alleged breach of contract and tortious acts. This matter was settled in April 2007 and did not have a material impact on the Company’s financial condition or results of operations. In addition, in early 2007 the Company was named as a co-defendant in various lawsuits involving claims relating to Sanofi-Aventis’ FDA-approved antibiotic Ketek, for which the Company provided certain clinical trial services. The Company records a reserve for pending and threatened litigation matters when an adverse outcome is probable and the amount of the potential liability is reasonably estimable. Although the ultimate outcome of these matters is currently not determinable, management of the Company, after consultation with legal counsel, does not believe that the resolution of these matters will have a material effect upon the Company’s financial condition, results of operations or cash flows.

 

11. BUSINESS SEGMENT DATA

Revenue by principal business segment is separately stated in the consolidated condensed financial statements. Income (loss) from operations and identifiable assets by principal business segment were as follows:

 

      Three Months Ended
June 30,
    Six Months Ended
June 30,
 

(in thousands)

   2006     2007     2006    2007  

Income (loss) from operations:

         

Development

   $ 49,655     $ 64,750     $ 98,253    $ 126,306  

Discovery Sciences

     (626 )     (3,655 )     11,704      (5,174 )
                               

Total

   $ 49,029     $ 61,095     $ 109,957    $ 121,132  
                               

 

     

December 31,

2006

  

June 30,

2007

Identifiable assets:

     

Development

   $ 1,394,850    $ 1,457,530

Discovery Sciences

     86,715      84,001
             

Total

   $ 1,481,565    $ 1,541,531
             

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis is provided to increase understanding of, and should be read in conjunction with, our consolidated condensed financial statements and accompanying notes. In this discussion, the words “PPD”, “we”, “our” and “us” refer to Pharmaceutical Product Development, Inc., together with its subsidiaries where appropriate.

Forward-looking Statements

This Form 10-Q contains forward-looking statements within the meaning of the federal securities laws. These statements relate to future events or our future financial performance. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, expectations, predictions, assumptions and other statements that are not statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as “might”, “will”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “predict”, “intend”, “potential” or “continue”, or the negative of these terms, or other comparable terminology. These statements are only predictions. These statements rely on a number of assumptions and estimates that could be inaccurate and that are subject to risks and uncertainties. Actual events or results might differ materially due to a number of factors, including those listed in “Potential Volatility of Quarterly Operating Results and Stock Price” below and in “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2006. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Company Overview

We are a leading global contract research organization providing drug discovery and development services, post-approval expertise and compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. Our corporate mission is to help clients and partners maximize returns on their research and development investments and accelerate the delivery of safe and effective therapeutics to patients.

We have been in the drug development business for more than 21 years. Our development services include preclinical programs and Phase I to Phase IV clinical development services as well as bioanalytical product testing and clinical laboratory services. We have extensive clinical trial experience including regional, national and global studies across a multitude of therapeutic areas and in various parts of the world. In addition, for marketed drugs, biologics and devices, we offer support such as product launch services, medical information, patient compliance programs, patient and disease registry programs, product safety and pharmacovigilance, Phase IV monitored studies and prescription-to-over-the-counter programs.

With offices in 28 countries and more than 9,700 professionals worldwide, we have provided services to 45 of the top 50 pharmaceutical companies in the world as ranked by 2005 healthcare research and development spending. We also work with leading biotechnology and medical device companies and government organizations that sponsor clinical research. We are one of the world’s largest providers of drug development services to pharmaceutical, biotechnology and medical device companies and government organizations based on 2006 annual net revenues generated from contract research organizations.

Building on our outsourcing relationship with pharmaceutical and biotechnology clients, we established our discovery services business in 1997. This business primarily focuses on preclinical evaluations of anticancer and diabetes therapies, biomarker discovery and patient sample analysis services, and compound development and commercialization collaborations. We have developed a risk-sharing research and development model to help pharmaceutical and biotechnology clients develop compounds. Through collaborative arrangements based on this model, we assist our clients by sharing the risks and potential rewards of the development and commercialization of drugs at various stages of development.

Our integrated drug discovery and development services offer our clients a way to identify and develop drug candidates more quickly and cost-effectively. In addition, with global infrastructure, we are able to accommodate the multinational drug discovery and development needs of our clients. As a result of having core areas of expertise in discovery and development, we provide integrated services across the drug development spectrum. We use our proprietary informatics technology to support these services. For more detailed information on PPD, see our Annual Report on Form 10-K for the year ended December 31, 2006.

 

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Executive Overview

Our revenues are dependent on a relatively small number of industries and clients. As a result, we closely monitor the market for our services. For a discussion of the trends affecting our market, see “Item 1. Business—Trends Affecting the Drug Discovery and Development Industry” in our Annual Report on Form 10-K for the year ended December 31, 2006. Although we cannot predict the demand for CRO services for the remainder of 2007, we continue to believe that the traditional market drivers for our industry are intact. The volume of requests for proposals for our Phase II-IV clinical development services for the first six months of 2007 was comparable to the record period of the first half of 2006, so the demand for these services appears to be strong. Despite what appears to be a strong market, our new authorizations for the second quarter of 2007 were lower than expected. As a result, for the remainder of 2007, we intend to focus our resources on our business development efforts to increase our sales. We also plan to continue managing our recent growth and delivering timely, high quality services to our clients, which is fundamental to our business and future growth.

We believe there are specific opportunities for continued growth in certain areas of our business. Our Global Phase II through IV units had strong operating and financial performance in the first half of 2007, and we expect to see continued revenue growth in the remainder of 2007. We continue to add headcount within Phase II-IV global operations and are adding new offices in several countries and expanding our operations in others. Our bioanalytical laboratory also achieved strong revenue growth in the first half of 2007 and demand remains strong for LC/MS and immunochemistry services. Our GMP laboratory added 13 new clients in the second quarter of 2007 and demand from our European client base is increasing. The revenue in our central laboratory in the second quarter of 2007 was below our expectations due to slow specimen flow on several large awards where study start-up was delayed by the client. However, new central laboratory authorizations were well above our second quarter forecast, which we believe is evidence of solid demand for these services.

During the second quarter of 2007, we focused on recruiting for certain senior management and other positions within the Company. In May 2007, we hired William J. Sharbaugh as our new Chief Operating Officer. We are also actively recruiting for a Chief Financial Officer and selected other management positions to fill recent vacancies. We are pleased with the progress to date and plan to continue with our recruiting efforts.

We review various metrics to evaluate our financial performance, including period-to-period changes in backlog, new authorizations, cancellation rates, revenue, margins and earnings. In the second quarter of 2007, we had new authorizations of $473.0 million, a decrease of 0.6% over the second quarter of 2006. The cancellation rate for the second quarter of 2007 was 26.0%, higher than expected due in part to the low second quarter 2007 authorizations. Despite the lower-than-expected new authorizations in the second quarter, backlog grew to $2,386 million as of June 30, 2007, up 17.7% over June 30, 2006. The average length of the contracts in our backlog decreased to 31.3 months as of June 30, 2007 from 37.1 months as of June 30, 2006.

Backlog by client type as of June 30, 2007 was 49.3% pharmaceutical, 37.2% biotech and 13.5% government/other as compared to 51.6% pharmaceutical, 33.6% biotech and 14.8% government/other as of June 30, 2006. This change in the composition of our backlog is primarily the result of a decrease in authorizations from pharmaceutical companies and an increase in authorizations from biotech companies since June 2006. Net revenue by client type for the quarter ended June 30, 2007 was 59.1% pharmaceutical, 29.4% biotech and 11.5% government/other compared to 58.8% pharmaceutical, 28.8% biotech and 12.4% government/other for the quarter ended June 30, 2006.

For the second quarter of 2007, net revenue contribution by service area was 81.7% for Phase II-IV services, 13.3% for laboratory services, 3.6% for the Phase I clinic and 1.4% for discovery sciences compared to net revenue contribution for the year ended December 31, 2006 of 78.0% for Phase II-IV services, 15.3% for laboratory services, 3.8% for the Phase I clinic and 2.9% for discovery sciences. Top therapeutic areas by net revenue for the quarter ended June 30, 2007 were oncology, anti-infective/anti-viral, endocrine/metabolic, circulatory/cardiovascular and central nervous system. For a detailed discussion of our revenue, margins, earnings and other financial results for the quarter ended June 30, 2007, see “Results of Operations – Three Months Ended June 30, 2006 versus Three Months Ended June 30, 2007” below.

 

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Capital expenditures for the three months ended June 30, 2007 totaled $24.7 million. These capital expenditures were primarily for computer software and hardware, construction costs for our new corporate headquarters building, scientific equipment for our laboratory units, and various building improvements. We made these investments to support our growing businesses and to improve the efficiencies of our operations. For the remainder of 2007, we expect to spend $37 million to $42 million for capital expenditures. The majority of the remaining forecasted capital expenditures are related to the up-fit costs for facilities, information technology expenditures and additional laboratory equipment.

As of June 30, 2007, we had $403.1 million of cash, cash equivalents and short-term investments. In the second quarter of 2007, we generated $23.6 million in cash from operations. The number of days’ revenue outstanding in accounts receivable and unbilled services, net of unearned income, also known as DSO, was 46.1 days for the six months ended June 30, 2007, up from 44.0 days for the year ended December 31, 2006. The increase in DSO is the result of, among other things, longer contractual payment terms, resulting in our accounts receivable aged more than 60 days increasing from 8.6% of total accounts receivable at December 31, 2006 to 13.2% of total accounts receivable at June 30, 2007. We are closely monitoring the timely billing and collection of receivables in accordance with our contractual payment terms, however DSO will continue to fluctuate from quarter to quarter based on future contract terms, the mix of contracts performed, and our success in collecting receivables.

With regard to our compound partnering arrangements, the dipeptidyl peptidase, or DPP4, program in type 2 diabetes with Takeda Pharmaceuticals continues to progress. In addition, ALZA Corporation, a subsidiary of Johnson & Johnson, said that it intends to file a marketing application for dapoxetine in Europe in late 2007 and is evaluating the possibility of a filing in Canada. Finally, Accentia continues to advance the SinuNase Phase III program for chronic sinusitis and has indicated that it expects to see results before the end of 2007.

In February 2007, we exercised an option to license a statin compound from Ranbaxy Laboratories Ltd. that we are developing as a treatment for dyslipidemia, a metabolic disorder often characterized by high cholesterol levels. We are solely responsible, and will bear all costs and expenses, for the development, manufacture, marketing and commercialization of the compound and licensed products. We filed the investigational new drug application, or IND, for the statin compound in late March 2007. We completed a single ascending dose, first-in-human study for this statin in June 2007, and the compound was safe and well tolerated at all doses in this trial. We recently commenced a first-in-patient study and plan to proceed into a Phase II proof-of-concept study in the fourth quarter of 2007. In addition, we initiated a drug-drug interaction study to determine if there is any interaction between our statin and gemfibrozil, a fibrate commonly used to lower triglycerides. As a result of the progression of the clinical development of this compound, we expect to incur significantly higher research and development expenses in the second half of 2007.

These drug development collaborations allow us to leverage our resources and global drug development expertise to create new opportunities for growth and to share the risks and potential rewards of drug development with our clients. For a background discussion of our compound partnering arrangements, see “Item 1. Business – Our Services – Our Discovery Sciences Group – Compound Collaboration Programs” in our Annual Report on Form 10-K for the year ended December 31, 2006. We believe our compound partnering strategy uses our cash resources and drug development expertise to drive mid- to long-term shareholder value. In the remainder of 2007, we plan to continue advancing our existing collaborations and evaluate new potential strategies and opportunities in this area.

New Business Authorizations and Backlog

New business authorizations, which are sales of our services, are added to backlog when we enter into a contract or letter of intent or receive a verbal commitment. Authorizations can vary significantly from quarter to quarter and contracts generally have terms ranging from several months to several years. We recognize revenue on these authorizations as services are performed. Our new authorizations for the three months ended June 30, 2006 and 2007 were $475.9 million and $473.0 million, respectively.

Our backlog consists of new business authorizations for which the work has not started but is anticipated to begin in the future and contracts in process that have not been completed. As of June 30, 2007, the remaining duration of the contracts in our backlog ranged from one to 118 months, with an average duration of 31.3 months. We expect the average duration of the contracts in our backlog to fluctuate from quarter to quarter in the future, based on the contracts constituting our backlog at any given time. Amounts included in backlog represent future revenue and exclude revenue

 

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that we have previously recognized. We adjust backlog on a monthly basis to account for fluctuations in exchange rates. Once work begins on a project included in backlog, we recognize net revenue over the life of the contract as services are performed. Our backlog as of June 30, 2006 and 2007 was $2,027 million and $2,386 million, respectively. For various reasons discussed in “Item 1. Business – Backlog” in our Annual Report on Form 10-K for the year ended December 31, 2006, our backlog might never be recognized as revenue and is not necessarily a meaningful predictor of future performance.

Results of Operations

Revenue Recognition

We record revenue from contracts, other than time-and-material contracts, on a proportional performance basis in our Development and Discovery Sciences segments. To measure performance on a given date, we compare direct costs through that date to estimated total direct costs to complete the contract. Direct costs relate primarily to the amount of labor and labor related overhead costs for the delivery of services. We believe this is the best indicator of the performance of the contractual obligations. Increases in the estimated total direct costs to complete a contract without a corresponding proportional increase to the contract value result in a cumulative adjustment to the amount of revenue recognized in the period the change in estimate is determined. For time-and-material contracts in both our Development and Discovery Sciences segments, we recognize revenue as hours are worked, multiplied by the applicable hourly rate. For our Phase I, laboratory and biomarker businesses, we recognize revenue from unitized contracts as subjects or samples are tested, multiplied by the applicable unit price. We offer volume discounts to our large customers based on annual volume thresholds. We record an estimate of the annual volume rebate as a reduction of revenue throughout the period based on the estimated total rebate to be earned for the period.

In connection with the management of clinical trials, we pay, on behalf of our clients, fees to investigators and test subjects as well as other out-of-pocket costs for items such as travel, printing, meetings and couriers, and our clients reimburse us for these costs. As required by Emerging Issues Task Force 01-14, amounts paid by us as a principal for out-of-pocket costs are included in direct costs as reimbursable out-of-pocket expenses and the reimbursements we receive as a principal are reported as reimbursed out-of-pocket revenue. In our statements of operations, we combine amounts paid by us as an agent for out-of-pocket costs with the corresponding reimbursements, or revenue, we receive as an agent. During the three months ended June 30, 2006 and 2007, fees paid to investigators and other fees we paid as an agent and the associated reimbursements were approximately $68.3 million and $91.2 million, respectively.

Most of our contracts can be terminated by our clients either immediately or after a specified period following notice. These contracts typically require the client to pay us the expenses to wind down the study, fees earned to date and, in some cases, a termination fee or some portion of the fees or profit that we could have earned under the contract if it had not been terminated early. Therefore, revenue recognized prior to cancellation generally does not require a significant adjustment upon cancellation. If we determine that a loss will result from the performance of a contract, the entire amount of the estimated loss is charged against income in the period in which such determination is made.

The Discovery Sciences segment also generates revenue from time to time in the form of milestone payments in connection with licensing of compounds. We only recognize milestone payments as revenue if the specified milestone is achieved and accepted by the client, and continued performance of future research and development services related to that milestone is not required.

Recording of Expenses

We generally record our operating expenses among the following categories:

 

   

direct costs;

 

   

research and development;

 

   

selling, general and administrative;

 

   

depreciation; and

 

   

amortization.

Direct costs consist of amounts necessary to carry out the revenue and earnings process, and include direct labor and related benefit charges, other costs directly related to contracts, an allocation of facility and information technology costs, and reimbursable out-of-pocket expenses. Direct costs, as a percentage of net revenue, tend to and are expected to fluctuate from one period to another as a result of changes in labor utilization and the mix of service offerings involved in the hundreds of studies being conducted during any period of time.

 

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Research and development, or R&D, expenses consist primarily of patent expenses, labor and related benefit charges associated with personnel performing internal research and development work, supplies associated with this work, consulting services and an allocation of facility and information technology costs.

Selling, general and administrative, or SG&A, expenses consist primarily of administrative payroll and related benefit charges, sales, advertising and promotional expenses, recruiting and relocation expenses, training costs, administrative travel, an allocation of facility and information technology costs, and costs related to operational employees performing administrative tasks.

We record depreciation expenses on a straight-line method, based on estimated useful lives of 40 to 50 years for buildings, five years for laboratory equipment, two to five years for software, computers and related equipment, and five to ten years for furniture and equipment, except for aircrafts, which we depreciate over 30 years. We depreciate leasehold improvements over the shorter of the life of the relevant lease or the useful life of the improvement. We depreciate property under capital leases over the life of the asset or the lease term, whichever is shorter.

We record amortization expenses on intangible assets on a straight-line method over the life of the intangible assets.

Three Months Ended June 30, 2006 versus Three Months Ended June 30, 2007

The following table sets forth amounts from our consolidated condensed financial statements along with the dollar and percentage change for the three months ended June 30, 2006 compared to the three months ended June 30, 2007.

 

     

Three Months Ended

June 30,

(unaudited)

            

(in thousands, except per share data)

   2006    2007    $ Inc (Dec)     % Inc (Dec)  

Net revenue:

          

Development

   $ 278,890    $ 316,527    $ 37,637     13.5 %

Discovery Sciences

     4,550      4,500      (50 )   (1.1 )

Reimbursed out-of-pockets

     25,513      28,943      3,430     13.4  
                        

Total net revenue

     308,953      349,970      41,017     13.3  

Direct costs:

          

Development

     140,022      157,515      17,493     12.5  

Discovery Sciences

     2,069      2,462      393     19.0  

Reimbursable out-of-pocket expenses

     25,513      28,943      3,430     13.4  
                        

Total direct costs

     167,604      188,920      21,316     12.7  

Research and development expenses

     1,261      3,963      2,702     214.3  

Selling, general and administrative expenses

     79,649      82,149      2,500     3.1  

Depreciation

     11,286      13,765      2,479     22.0  

Amortization

     124      78      (46 )   (37.1 )
                        

Income from operations

     49,029      61,095      12,066     24.6  

Interest and other income, net

     4,521      4,015      (506 )   (11.2 )
                        

Income before provision for income taxes

     53,550      65,110      11,560     21.6  

Provision for income taxes

     17,136      22,463      5,327     31.1  
                        

Net income

   $ 36,414    $ 42,647    $ 6,233     17.1 %
                        

Net income per diluted share

   $ 0.31    $ 0.36    $ 0.05     16.1 %
                        

 

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Total net revenue increased $41.0 million to $350.0 million in the second quarter of 2007. The increase in total net revenue resulted primarily from an increase in our Development segment revenue. The Development segment generated net revenue of $316.5 million, which accounted for 90.4% of total net revenue for the second quarter of 2007. The 13.5% increase in Development net revenue was primarily attributable to an increase in the level of Phase II through IV services we provided in the second quarter of 2007 as compared to 2006.

Total direct costs increased $21.3 million to $188.9 million in the second quarter of 2007 primarily as the result of an increase in the Development segment direct costs. Development direct costs increased $17.5 million to $157.5 million in the second quarter of 2007. The primary reason for this was an increase in personnel costs of $14.6 million due to the addition of over 750 new employees in our global Phase II through IV division. The remaining increase in development direct costs is primarily due to increased facility costs of $1.7 million as a result of the increase in personnel and an increase in professional fees of $1.4 million. Direct costs in the second quarter of 2007 were negatively impacted by approximately $3.4 million due to foreign currency fluctuation, as discussed below.

R&D expenses increased $2.7 million to $4.0 million in the second quarter of 2007. In February 2007, we exercised an option from Ranbaxy Laboratories Ltd. to license a statin compound that we are developing as a treatment for dyslipidemia, a metabolic disorder often characterized by high cholesterol levels. The increase in R&D expense in the second quarter of 2007 is primarily due to development costs associated with this compound. We are solely responsible for all costs and expenses for the development, manufacture, marketing and commercialization of the compound and licensed products. We plan to continue evaluating other compound partnering strategies and opportunities to drive mid- and long-term shareholder value. As a result of this new collaboration and any other compound partnering transaction that we might enter into in 2007, our R&D expense will increase in 2007 as compared to 2006.

SG&A expenses increased $2.5 million to $82.1 million in the second quarter of 2007. As a percentage of total net revenue, SG&A expenses decreased from 25.8% in the second quarter of 2006 to 23.5% in the second quarter of 2007. The increase in SG&A expenses in absolute terms includes additional personnel costs of $3.5 million due to hiring additional operations infrastructure and administrative personnel to support expanding operations and revenue growth. This increase was partially offset by a decrease in travel expenses of $1.0 million.

Depreciation expense increased $2.5 million to $13.8 million in the second quarter of 2007. The increase was related to property and equipment we acquired to accommodate our growth. Capital expenditures were $24.7 million in the second quarter of 2007. Capital expenditures included $10.9 million for computer software and hardware, $6.9 million for our new corporate headquarters building, $3.6 million for additional scientific equipment for our laboratory units and $3.5 million related to leasehold improvements at various sites. We expected depreciation to increase in 2007 as a result of substantial investments over the past couple years in information technology systems to support our global Phase II-IV business and the additional depreciation related to our new corporate headquarters building.

Income from operations increased $12.1 million from $49.0 million in the second quarter of 2006 to $61.1 million in the second quarter of 2007. Income from operations in the second quarter of 2007 was negatively impacted by approximately $3.1 million of foreign currency fluctuation, primarily due to the weakening of the U.S. dollar relative to the pound sterling and euro. Although these currency movements increased net revenue in the aggregate, the negative impact on income from operations is attributable to dollar-denominated contracts for services rendered in countries other than the United States. In these cases, revenue is not impacted by the weakening of the U.S. dollar, but the costs associated with performing these contracts and maintaining the foreign infrastructure, which are paid in local currency, increase when translated to U.S. dollars, resulting in lower operating profits.

Interest and other income, net decreased $0.5 million to $4.0 million in the second quarter of 2007. The higher interest and other income in the second quarter of 2006 was mainly attributable to several one-time gains during the second quarter of 2006, offset in part by an increase in interest income in 2007 resulting from higher interest rates and a 19.4% increase in our average cash, cash equivalents and short-term investments balance in the second quarter of 2007 as compared to the second quarter of 2006.

Our provision for income taxes increased $5.3 million to $22.5 million in the second quarter of 2007 due to an increase in pre-tax income. Our effective income tax rate for the second quarter of 2007 was 34.5% compared to 32.0% for the second quarter of 2006. The effective tax rate for the second quarter of 2006 was positively impacted by the recognition of state tax benefits and the closing of audit periods for several state tax positions. These reductions decreased the effective tax rate for the second quarter of 2006 by 5.3%. The remaining difference in our effective tax

 

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rates for the second quarter of 2007 compared to the second quarter of 2006 is due to an increase in nontaxable income from cash investments and the change in geographic distribution of our pretax earnings among locations with varying tax rates.

Net income of $42.6 million in the second quarter of 2007 represents an increase of 17.1% from $36.4 million in the second quarter of 2006. Net income per diluted share of $0.36 in the second quarter of 2007 represents a 16.1% increase from net income per diluted share of $0.31 in the second quarter of 2006.

Six Months Ended June 30, 2006 versus Six Months Ended June 30, 2007

The following table sets forth amounts from our consolidated condensed financial statements along with the dollar and percentage change for the six months ended June 30, 2006 compared to the six months ended June 30, 2007.

 

     

Six Months Ended

June 30,

(unaudited)

            

(in thousands, except per share data)

   2006    2007    $ Inc (Dec)     % Inc (Dec)  

Net revenue:

          

Development

   $ 536,639    $ 616,683    $ 80,044     14.9 %

Discovery Sciences

     23,499      8,883      (14,616 )   (62.2 )

Reimbursed out-of-pockets

     48,184      56,656      8,472     17.6  
                        

Total net revenue

     608,322      682,222      73,900     12.1  

Direct costs:

          

Development

     268,439      309,430      40,991     15.3  

Discovery Sciences

     4,477      4,820      343     7.7  

Reimbursable out-of-pocket expenses

     48,184      56,656      8,472     17.6  
                        

Total direct costs

     321,100      370,906      49,806     15.5  

Research and development expenses

     1,942      5,868      3,926     202.2  

Selling, general and administrative expenses

     152,617      157,887      5,270     3.5  

Depreciation

     22,309      26,273      3,964     17.8  

Amortization

     397      156      (241 )   (60.7 )
                        

Income from operations

     109,957      121,132      11,175     10.2  

Interest and other income, net

     7,480      8,574      1,094     14.6  
                        

Income before provision for income taxes

     117,437      129,706      12,269     10.4  

Provision for income taxes

     39,177      45,072      5,895     15.0  
                        

Net income

   $ 78,260    $ 84,634    $ 6,374     8.1 %
                        

Net income per diluted share

   $ 0.66    $ 0.71    $ 0.05     7.6 %
                        

Total net revenue increased $73.9 million to $682.2 million in the first six months of 2007. The increase in total net revenue resulted primarily from an increase in our Development segment revenue partially offset by a decrease in our Discovery Sciences segment revenue. The Development segment generated net revenue of $616.7 million, which accounted for 90.4% of total net revenue for the first six months of 2007. The 14.9% increase in Development net revenue was primarily attributable to an increase in the level of Phase II through IV services we provided in the first six months of 2007 as compared to the first six months of 2006.

The Discovery Sciences segment generated net revenue of $8.9 million in the first six months of 2007, a decrease of $14.6 million from the first six months of 2006. The higher 2006 Discovery Sciences net revenue was mainly attributable to the $15.0 million milestone payment we earned from Takeda in March 2006 under the DPP4 agreement as a result of dosing of the twentieth patient in the Phase III trial.

 

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Total direct costs increased $49.8 million to $370.9 million in the first six months of 2007, primarily as the result of an increase in Development segment direct costs. Development direct costs increased $41.0 million to $309.4 million in the first six months of 2007. The primary reason for this was an increase in personnel costs of $32.2 million due to the addition of over 750 new employees in our global Phase II through IV division. The remaining increase in development direct costs is primarily due to increased facility costs of $5.4 million as a result of the increase in personnel and an increase in professional fees of $4.4 million. Direct costs in the first six months of 2007 were negatively impacted by approximately $6.7 million due to foreign currency fluctuation, as discussed below.

R&D expenses increased $3.9 million to $5.9 million in the first six months of 2007. In February 2007, we exercised an option from Ranbaxy Laboratories Ltd. to license a statin compound that we are developing as a treatment for dyslipidemia, a metabolic disorder often characterized by high cholesterol levels. The increase in R&D expense in the first six months of 2007 is primarily due to development costs associated with this compound. We are solely responsible for all costs and expenses for the development, manufacture, marketing and commercialization of the compound and licensed products. We plan to continue evaluating other compound partnering strategies and opportunities to drive mid- and long-term shareholder value. As a result of this new collaboration and any other compound partnering transaction that we might enter into in 2007, our R&D expense will increase during 2007 as compared to 2006.

SG&A expenses increased $5.3 million to $157.9 million in the first six months of 2007. As a percentage of total net revenue, SG&A expenses decreased to 23.1% in the first six months of 2007 compared to 25.1% in the first six months of 2006. The increase in SG&A expenses in absolute terms includes additional personnel costs of $8.4 million due to hiring additional operations infrastructure and administrative personnel to support expanding operations and revenue growth, as well as an additional $1.2 million in facility costs related to the increase in personnel. These increases were partially offset by decreases in travel costs of $1.6 million, loss on disposal of assets of $1.4 million and contract labor costs of $0.8 million.

Depreciation expense increased $4.0 million to $26.3 million in the first six months of 2007. The increase was related to property and equipment we acquired to accommodate our growth. Capital expenditures were $57.4 million in the first six months of 2007. We expect depreciation to increase in 2007 as a result of substantial investments over the past couple years in information technology systems to support our global Phase II-IV business and the additional depreciation related to our new corporate headquarters building.

Income from operations increased $11.2 million to $121.1 million in the first six months of 2007. Income from operations in the first six months of 2007 was negatively impacted by approximately $4.9 million of foreign currency fluctuation, primarily due to the weakening of the U.S. dollar relative to the pound sterling and euro. Although these currency movements increased net revenue in the aggregate, the negative impact on income from operations is attributable to dollar-denominated contracts for services rendered in countries other than the United States. In these cases, revenue is not impacted by the weakening of the U.S. dollar, but the costs associated with performing these contracts and maintaining the foreign infrastructure, which are paid in local currency, increase when translated to U.S. dollars, resulting in lower operating profits. Income from operations in the first six months of 2006 included a $15.0 million milestone payment from Takeda under the DPP4 collaboration agreement.

Interest and other income, net increased $1.1 million to $8.6 million in the first six months of 2007. Interest and other income in the first six months of 2006 included several one-time gains during the second quarter of 2006, offset in part by an increase in interest income in 2007 resulting from higher interest rates and a 27.1% increase in our average cash, cash equivalents and short-term investments balance in the first six months of 2007 as compared to the first six months of 2006.

Our provision for income taxes increased $5.9 million to $45.1 million in the first six months of 2007. Our effective income tax rate for the first six months of 2007 was 34.7% compared to 33.4% for the first six months of 2006. The effective tax rate for the first six months of 2006 was positively impacted by the recognition of state tax benefits and the closing of audit periods for several state tax positions. These reductions decreased the effective tax rate for the first six months of 2006 by 2.4%. The remaining difference in our effective tax rates for the first six months of 2007 compared to the first six months of 2006 is due to an increase in nontaxable income from cash investments and the change in the geographic distribution of our pretax earnings among locations with varying tax rates.

Net income of $84.6 million in the first six months of 2007 represents an increase of 8.1% from $78.3 million in the first six months of 2006. Net income per diluted share of $0.71 in the first six months of 2007 represents a 7.6% increase from net income per diluted share of $0.66 in the first six months of 2006. Earnings per diluted share for the first six months of 2006 included $0.08 per diluted share related to the Takeda DPP4 milestone.

 

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Liquidity and Capital Resources

As of June 30, 2007, we had $107.7 million of cash and cash equivalents, and $295.4 million of short-term investments. Our cash and cash equivalents and short-term investments are invested in financial instruments that are rated A or better by Standard & Poor’s or Moody’s and earn interest at market rates. Our expected primary cash needs on both a short- and long-term basis are for capital expenditures, expansion of services, possible acquisitions, investments and compound partnering collaborations, geographic expansion, dividends, working capital and other general corporate purposes. We have historically funded our operations, dividends and growth, including acquisitions, primarily with cash flow from operations.

In the first six months of 2007, our operating activities provided $84.6 million in cash as compared to $104.8 million for the same period last year. The primary decreases in cash flow from operating activities, comparing the two periods mentioned above, were due to a decrease in accounts payable and other accrued expenses of $19.0 million, an increase in receivables of $8.0 million, an increase in advance payments of $5.3 million, a decrease in current income taxes of $4.3 million, a decrease in unearned income of $4.1 million and an increase in other assets of $4.1 million. These uses of cash were partially offset by an increase in payables to investigators of $14.2 million. The decrease in accounts payable and other accrued expenses in the six months ended June 30, 2007 as compared to the six months ended June 30, 2006 was due to decreases in benefit accruals and accruals related to software license and maintenance agreements.

In the first six months of 2007, we used $96.7 million of cash in investing activities. We used cash to purchase available-for-sale investments of $177.0 million, make capital expenditures of $57.4 million and purchase investments of $1.5 million. These amounts were partially offset by maturities and sales of available-for-sale investments of $136.9 million, proceeds from the sale of property and equipment of $1.5 million primarily related to the sale of our building in Kersewell, Scotland, and proceeds from our investments of $0.7 million. Our capital expenditures in the first six months of 2007 primarily consisted of $28.6 million for our new corporate headquarters building, $14.7 million for computer software and hardware, $6.6 million for additional scientific equipment for our laboratory units and $5.9 million related to leasehold improvements at various sites. We expect our capital expenditures for the remainder of 2007 will be approximately $37 million to $42 million. The majority of the remaining forecasted capital expenditures are related to the up-fit costs for facilities, information technology expenditures and additional laboratory equipment.

In the first six months of 2007, we used $61.6 million of cash in financing activities. We paid $74.8 million to retire our construction loan for our new headquarters building, paid dividends of $7.1 million and made repayments of capital lease obligations of $0.3 million. These amounts were partially offset by proceeds of $17.7 million from stock option exercises and purchases under our employee stock purchase plan, as well as $2.9 million in income tax benefits from the exercise of stock options and disqualifying dispositions of stock. In addition, we borrowed and subsequently repaid $25.0 million under our revolving credit facility in connection with the construction of the new headquarters building.

 

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The following table sets forth amounts from our consolidated balance sheet affecting our working capital, along with the dollar amount of the change from December 31, 2006 to June 30, 2007.

 

(in thousands)

  

December 31,

2006

  

June 30,

2007

  

$ Inc (Dec)

 
        

Current assets:

        

Cash and cash equivalents

   $ 179,795    $ 107,710    $ (72,085 )

Short-term investments

     255,876      295,427      39,551  

Accounts receivable and unbilled services, net

     408,917      453,348      44,431  

Income tax receivable

     510      299      (211 )

Investigator advances

     13,490      15,066      1,576  

Prepaid expenses and other current assets

     36,495      45,893      9,398  

Deferred tax assets

     13,119      21,760      8,641  
                      

Total current assets

   $ 908,202    $ 939,503    $ 31,301  

Current liabilities:

        

Accounts payable

   $ 15,235    $ 24,657    $ 9,422  

Payables to investigators

     43,717      52,721      9,004  

Accrued income taxes

     16,560      23,229      6,669  

Other accrued expenses

     149,027      137,633      (11,394 )

Deferred tax liabilities

     86      98      12  

Unearned income

     195,707      184,289      (11,418 )

Current maturities of long-term debt and capital lease obligations

     75,159      69      (75,090 )
                      

Total current liabilities

   $ 495,491    $ 422,696    $ (72,795 )

Working capital

   $ 412,711    $ 516,807    $ 104,096  

Working capital as of June 30, 2007 was $516.8 million compared to $412.7 million at December 31, 2006. The increase in working capital was due primarily to increases in short-term investments and accounts receivable and unbilled services and decreases in current maturities of debt, unearned income and other accrued expenses. These increases were partially offset by a decrease in cash and cash equivalents.

The number of days’ revenue outstanding in accounts receivable and unbilled services, net of unearned income, also known as DSO, increased to 46.1 days for the six months ended June 30, 2007 from 44.0 days for the year ended December 31, 2006. We calculate DSO by dividing accounts receivable and unbilled services less unearned income by average daily gross revenue for the applicable period. The increase in DSO is the result of, among other things, longer contractual payment terms, resulting in our accounts receivable aged more than 60 days increasing from 8.6% of total accounts receivable at December 31, 2006 to 13.2% of total accounts receivable at June 30, 2007. We are closely monitoring the timely billing and collection of receivables in accordance with our contractual payment terms, however DSO will continue to fluctuate from quarter to quarter based on future contract terms, the mix of contracts performed, and our success in collecting receivables.

We assess our investment portfolio on a quarterly basis for other-than-temporary impairments. At June 30, 2007, the cost basis of our investment in Accentia exceeded its fair value by $3.7 million. The security has been in a loss position for less than four months. Each quarter we evaluate the market condition of the overall industry, historical and projected financial performance and market values, the status of the company’s development and commercialization efforts, expected cash needs, and recent funding events, as well as our expected holding period and the length of time and the extent to which the fair value of our investment has been less than cost. Based on our assessment of the above factors, we did not consider the unrealized loss to be an other-than-temporary impairment at June 30, 2007.

Effective July 1, 2007, we renewed our $50.0 million revolving credit facility with Bank of America, N. A. Indebtedness under the facility is unsecured and subject to covenants relating to financial ratios and restrictions on certain types of transactions. This revolving credit facility does not expressly restrict or limit the payment of dividends, and we do not expect any of the covenants to affect our ability to pay dividends under our cash dividend policy for the foreseeable future. We were in compliance with all loan covenants as of June 30, 2007. Outstanding borrowings under

 

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the facility bear interest at an annual fluctuating rate equal to the one-month London Interbank Offered Rate, or LIBOR, plus a margin of 0.6%. Borrowings under this credit facility are available to provide working capital and for general corporate purposes. This credit facility is currently scheduled to expire in June 2008, at which time any outstanding balance will be due. As of June 30, 2007, no borrowings were outstanding under this credit facility, although the aggregate amount available for borrowing had been reduced by $1.2 million due to outstanding letters of credit issued under this facility.

In February 2006, we entered into an $80.0 million construction loan facility with Bank of America, N.A. This construction loan facility was in addition to the $50.0 million revolving credit facility discussed above. Indebtedness under the construction loan facility was unsecured and subject to the same covenants as the revolving credit facility, as well as additional covenants commonly used in construction loan agreements. Borrowings under this credit facility were used to finance the construction of our new corporate headquarters building and related parking facility in Wilmington, North Carolina, and bore interest at an annual fluctuating rate equal to the one-month LIBOR plus a margin of 0.6%. This credit facility was scheduled to mature in February 2008, but during the six months ended June 30, 2007, we repaid all outstanding borrowings, totaling $74.8 million, under this facility.

On October 3, 2005, our Board of Directors adopted a cash dividend policy. We paid the first quarterly cash dividend under our dividend policy in the fourth quarter of 2005, and in each of the first three quarters of 2006, we paid a similar dividend of $0.025 per share. In October 2006, our Board of Directors amended the annual cash dividend policy to increase the annual dividend rate by 20 percent, from $0.10 to $0.12 per share, payable quarterly at a rate of $0.03 per share. The new dividend rate was effective beginning in the fourth quarter of 2006. The cash dividend policy and the payment of future quarterly cash dividends under that policy are not guaranteed and are subject to the discretion of and continuing determination by our Board of Directors that the policy remains in the best interests of our shareholders and in compliance with applicable laws and agreements.

We have commitments to invest an aggregate additional $19.0 million in three venture capital funds. For further details, see Note 5 in the Notes to Consolidated Condensed Financial Statements.

We adopted the provisions of FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes – an interpretation of FASB Statement No. 109”, or FIN 48, as of January 1, 2007. As of December 31, 2006, we had recorded a contingent tax liability of $9.1 million. As a result of the implementation of FIN 48, we reclassified $8.2 million of this liability to non-current liabilities and recognized an increase in this non-current liability of $22.8 million. This increase was accounted for as a $5.6 million decrease in retained earnings, a $15.9 million increase in deferred tax assets, and a $1.3 million increase in long-term assets as of January 1, 2007. We had gross unrecognized tax benefits of approximately $28.2 million as of January 1, 2007. Of this total, $11.6 million, net of the federal benefit on state taxes, is the amount that, if recognized, would result in a reduction of our effective tax rate. We do not anticipate a significant change in total unrecognized tax benefits or our effective tax rate due to the settlement of audits and the expiration of statute of limitations within the next 12 months.

Our policy for recording interest and penalties associated with tax audits is to record such items as a component of provision for income taxes. In conjunction with the adoption of FIN 48, we recognized approximately $4.0 million for the payment of interest and penalties at January 1, 2007. To the extent interest and penalties are not assessed with respect to uncertain tax positions, amounts accrued will be reduced and reflected as a reduction of the overall income tax provision.

We analyzed filing positions in all of the significant federal, state and foreign jurisdictions where we are required to file income tax returns, as well as open tax years in these jurisdictions. The only periods subject to examination by the major tax jurisdictions where we do business are the 2003 through 2006 tax years. Various foreign income tax returns are under examination by taxing authorities. We do not believe that the outcome of any examination will have a material impact on our financial condition or results of operations.

We have been involved in compound development and commercialization collaborations since 1997. We developed a risk-sharing research and development model to help pharmaceutical and biotechnology clients develop compounds. Through collaboration arrangements based on this model, we assist our clients by sharing the risks and potential rewards associated with the development and commercialization of drugs at various stages of development. As of June 30, 2007, we had four such arrangements that involve the potential future receipt of one or more of the following: payments upon the achievement of development and regulatory milestones; royalty payments if the compound is approved for sale; sales-based milestone payments; and a share of net sales up to a specified dollar limit. The compounds that are the subject of these collaborations are still in development and have not been approved for sale in any country.

 

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Our collaboration with ALZA Corporation, a subsidiary of Johnson & Johnson, for dapoxetine requires us to pay a royalty to Eli Lilly & Company of 5% on annual net sales of the compound in excess of $800 million. ALZA received a “not approvable” letter from the FDA in October 2005, but has continued its global development program and has said that it intends to file a marketing application for dapoxetine in Europe in late 2007 and is evaluating the possibility of a filing in Canada. As a result of the risks associated with drug development, including obtaining regulatory approval to sell in any country, the receipt of any further milestone payments, royalties or other payments with respect to any of our drug development collaborations is uncertain.

In February 2007, we exercised an option to license from Ranbaxy Laboratories Ltd. a statin compound that we intend to develop as a treatment for dyslipidemia, a metabolic disorder often characterized by high cholesterol levels. The option was exercised pursuant to an agreement entered into effective as of December 15, 2006. Upon exercise of the option, we paid a one-time license fee of $0.25 million. Under the agreement, we have an exclusive license to make, use, sell, import and sublicense the compound and any licensed product anywhere in the world for any human use. We are solely responsible, and will bear all costs and expenses, for the development, manufacture, marketing and commercialization of the compound and licensed products. In addition to the one-time license fee, we are obligated to pay Ranbaxy milestone payments upon the occurrence of specified clinical development events. If a licensed product is approved for sale, we must also pay Ranbaxy royalties based on sales of the product, as well as commercial milestone payments based on the achievement of specified worldwide sales targets. If all criteria are met, the total amount of potential clinical and sales-based milestones would be $44.0 million. We filed the investigational new drug application, or IND, for the statin compound in late March 2007. We completed a single ascending dose, first-in-human study for this statin in June 2007, and the compound was safe and well tolerated at all doses in this trial. We recently commenced a first-in-patient study and plan to proceed into a Phase II proof-of-concept study in the fourth quarter of 2007. In addition, we initiated a drug-drug interaction study to determine if there is any interaction between our statin and gemfibrozil, a fibrate commonly used to lower triglycerides.

Under most of our agreements for Development services, we agree to indemnify and defend the sponsor against third party claims based on our negligence or willful misconduct. Any successful claims could have a material adverse effect on our financial condition, results of operations and future prospects.

We expect to continue expanding our operations through internal growth, strategic acquisitions and investments. We expect to fund these activities and the payment of future cash dividends from existing cash, cash flows from operations and, if necessary or appropriate, borrowings under our existing or future credit facilities. We believe that these sources of liquidity will be sufficient to fund our operations and dividends for the foreseeable future. From time to time, we evaluate potential acquisitions, investments and other growth opportunities that might require additional external financing, and we might seek funds from public or private issuances of equity or debt securities. While we believe we have sufficient liquidity to fund our operations for the foreseeable future, our sources of liquidity and ability to pay dividends could be affected by our dependence on a small number of industries and clients; compliance with regulations; reliance on key personnel; breach of contract, personal injury or other tort claims; international risks; environmental or intellectual property claims; or other factors described below under “Potential Liability and Insurance”, “Potential Volatility of Quarterly Operating Results and Stock Price” and “Quantitative and Qualitative Disclosures about Market Risk”. In addition, see “Risk Factors,” “Contractual Obligations” and “Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2006.

Contractual Obligations

As a result of the adoption of FIN 48 on January 1, 2007, we have a liability of unrecognized tax benefits of approximately $28.2 million. We estimate that approximately $0.6 million will be paid in the next 12 months. We are unable to reasonably estimate the amount or timing of payments for the remainder of the liability. Other than the adoption of FIN 48, there have been no significant changes to the Contractual Obligation table included in our Annual Report on Form 10-K for the year ended December 31, 2006.

 

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Critical Accounting Policies and Estimates

The preparation of financial statements in accordance with generally accepted accounting pronouncements requires management to make estimates and assumptions that affect reported amounts and related disclosures. We have discussed those estimates that we believe are critical and require the use of complex judgment in their application in our 2006 Annual Report on Form 10-K. In addition, we adopted FIN 48 as of January 1, 2007. FIN 48 requires significant judgment in determining what constitutes an individual tax position as well as assessing the outcome of each tax position. Changes in judgment as to recognition or measurement of tax positions can materially affect the estimate of our effective tax rate and, consequently, our operating results. We consider many factors when evaluating and estimating our tax positions and tax benefits, which may require periodic adjustments and which may not accurately anticipate actual outcomes. Other than the adoption of FIN 48, our critical accounting policies and the methodologies and assumptions we apply under them have not materially changed since the date of our 2006 Annual Report on Form 10-K. For more detailed information on our critical accounting policies and estimates, see our Annual Report on Form 10-K for the year ended December 31, 2006.

Recent Accounting Pronouncements

Recently issued accounting standards relevant to our financial statements, which are described in “Recent Accounting Pronouncements” in Note 1 in the Notes to Consolidated Condensed Financial Statements are:

 

Date

  

Title

  

Effective Date

July 2006    Interpretation No. 48, “Accounting for Uncertainty in Income Taxes – an interpretation of FASB Statement No. 109”    Fiscal years beginning after December 15, 2006
September 2006    SFAS No. 157, “Fair Value Measurements”    Fiscal years beginning after November 15, 2007 and interim periods within those years
September 2006    SFAS No. 158, “Employers’ Accounting for Defined Benefit Pension and Other Postretirement Plans – an amendment of FASB Statements No. 87, 88, 106, and 132(R)”    Recognition of asset and liability of funded status – fiscal years ending after December 15, 2006. Measurement date provision – fiscal years ending after December 15, 2008
February 2007    SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities – Including an amendment of FASB Statement No. 115”    Fiscal years beginning after November 15, 2007
June 2007    EITF Issue 06-11, “Accounting for Income Tax Benefits of Dividends on Share-Based Payment Awards”    Fiscal years beginning after December 15, 2007
June 2007    EITF Issue 07-03, “Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities”    Fiscal years beginning after December 15, 2007

Income Taxes

Because we conduct operations on a global basis, our effective tax rate has and will continue to depend upon the geographic distribution of our pretax earnings among locations with varying tax rates. Our profits are also impacted by changes in the tax rates of the various tax jurisdictions. In particular, as the geographic mix of our pretax earnings among various tax jurisdictions changes, our effective tax rate might vary from period to period.

 

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Inflation

Our long-term contracts, those in excess of one year, generally include an inflation or cost of living adjustment for the portion of the services to be performed beyond one year from the contract date. In the event that actual inflation rates are greater than our contractual inflation rates or cost of living adjustments, inflation could have a material adverse effect on our operations or financial condition.

Potential Liability and Insurance

Drug development services involve the testing of potential drug candidates on human volunteers pursuant to a study protocol. This testing exposes us to the risk of liability for personal injury or death to volunteers and patients resulting from, among other things, possible unforeseen adverse side effects or improper administration of the study drug or use of the drug following regulatory approval. For example, we have been named as a defendant in a number of lawsuits relating to the antibiotic Ketek, as described in Part II, Item 1 – “Legal Proceedings”. We attempt to manage our risk of liability for personal injury or death to volunteers and patients from administration of study products through standard operating procedures, patient informed consent, contractual indemnification provisions with clients and insurance. We monitor clinical trials in compliance with government regulations and guidelines. We have established global standard operating procedures intended to satisfy regulatory requirements in all countries in which we have operations and to serve as a tool for controlling and enhancing the quality of drug development services. The contractual indemnifications generally do not protect us against all our own actions, such as gross negligence. We currently maintain professional liability insurance coverage with limits we believe are adequate and appropriate.

Potential Volatility of Quarterly Operating Results and Stock Price

Our quarterly and annual operating results have fluctuated in the past, and we expect that they will continue to fluctuate in the future. Factors that could cause these fluctuations to occur include:

 

   

the timing and level of new business authorizations;

 

   

our ability to recruit and retain experienced personnel;

 

   

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

 

   

the timing and amount of costs associated with R&D and compound partnering collaborations;

 

   

the timing of our Discovery Sciences segment milestone payments or other revenue, if any;

 

   

our ability to properly manage our growth;

 

   

litigation costs;

 

   

the timing of the opening of new offices;

 

   

the timing of other internal expansion costs;

 

   

exchange rate fluctuations between periods;

 

   

our dependence on a small number of industries and clients;

 

   

the mix of products and services sold in a particular period;

 

   

pricing pressure in the market for our services;

 

   

rapid technological change;

 

   

the timing and amount of start-up costs incurred in connection with the introduction of new products and services;

 

   

the timing and extent of new government regulations;

 

   

intellectual property risks;

 

   

impairment of investments or intangible assets; and

 

   

the timing and amount of costs associated with integrating acquisitions.

Delays and terminations of trials are often the result of actions taken by our clients or regulatory authorities, and are not typically controllable by us. Because a large percentage of our operating costs are relatively fixed while revenue is subject to fluctuation, variations in the timing and progress of large contracts can materially affect our quarterly operating results. For these reasons, we believe that comparisons of our quarterly financial results are not necessarily meaningful and should not be relied upon as an indication of future performance.

Recent consolidations and other transactions involving competitors could increase the competition within our industry for clients, experienced personnel and acquisition candidates. For example, in 2006, Covance acquired Radiant Research and

 

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Kendle acquired the Phase II-IV clinical business of Charles River Laboratories. These consolidations and other potential future transactions, such as the recently announced acquisition of PRA International by Genstar Capital, a private equity firm, could increase competition in our industry.

Fluctuations in quarterly results, actual or anticipated changes in our dividend policy or other factors could affect the market price of our common stock. These factors include ones beyond our control, such as changes in revenue and earnings estimates by analysts, market conditions in our industry, disclosures by product development partners and actions by regulatory authorities with respect to potential drug candidates, changes in pharmaceutical, biotechnology and medical device industries and the government sponsored clinical research sector and general economic conditions. Any effect on our common stock could be unrelated to our longer-term operating performance. For further details, see “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2006.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

We are exposed to foreign currency risk by virtue of our international operations. We derived approximately 32.1% and 34.9% of our net revenues for the three months ended June 30, 2006 and 2007, respectively, from operations outside the United States. We generally reinvest funds generated by each subsidiary in the country where they are earned. Our operations in the United Kingdom generated more than 37.6% of our net revenue from international operations during the three months ended June 30, 2007. Accordingly, we are exposed to adverse movements in foreign currencies, predominately in the pound sterling.

The vast majority of our contracts are entered into by our U.S. or U.K. subsidiaries. The contracts entered into by the U.S. subsidiaries are almost always denominated in U.S. dollars. Contracts entered into by our U.K. subsidiaries are generally denominated in U.S. dollars, pounds sterling or euros, with the majority in U.S. dollars. Although an increase in exchange rates for the pound sterling or euro relative to the U.S. dollar would increase net revenue from contracts denominated in these currencies, a negative impact on income from operations results from dollar-denominated contracts for services rendered in countries other than the United States. In these cases, revenue is not impacted by the weakening of the U.S. dollar, but the costs associated with performing these contracts, which are paid in local currency, are negatively impacted when translated into U.S. dollars.

We also have currency risk resulting from the passage of time between the invoicing of clients under contracts and the collection of client payments against those invoices. If a contract is denominated in a currency other than the subsidiary’s local currency, we recognize a receivable at the time of invoicing for the local currency equivalent of the foreign currency invoice amount. Changes in exchange rates from the time the invoice is prepared until payment from the client will result in our receiving either more or less in local currency than the local currency equivalent of the receivable. We recognize this difference as a foreign currency transaction gain or loss, as applicable, and report it in other income, net. If the exchange rate on accounts receivable balances denominated in pounds sterling had increased by 10%, our foreign currency transaction loss would have increased by $2.2 million in the quarter ended June 30, 2007.

Our strategy for managing foreign currency risk relies primarily on receiving payment in the same currency used to pay expenses. If the U.S. dollar had weakened an additional 10% relative to the pound sterling, euro and Brazilian real in the second quarter of 2007, net income would have been approximately $2.1 million lower for the quarter based on revenues and costs related to our foreign operations. From time to time, we also enter into foreign currency hedging activities in an effort to manage our potential foreign exchange exposure. At June 30, 2007, no such hedging contracts were outstanding. In July 2007, we entered into a foreign exchange forward contract in order to hedge a portion of our foreign currency exposure. The face amount of this foreign exchange contract was $36.0 million.

Changes in exchange rates between the applicable foreign currency and the U.S. dollar will affect the translation of foreign subsidiaries’ financial results into U.S. dollars for purposes of reporting our consolidated financial results. The process by which we translate each foreign subsidiary’s financial results to U.S. dollars is as follows:

 

   

we translate income statement accounts at average exchange rates for the period;

 

   

we translate balance sheet assets and liability accounts at end of period exchange rates; and

 

   

we translate equity accounts at historical exchange rates.

Translation of the balance sheet in this manner affects shareholders’ equity through the cumulative translation adjustment account. This account exists only in the foreign subsidiary’s U.S. dollar balance sheet and is necessary to keep the foreign balance sheet, stated in U.S. dollars, in balance. We report translation adjustments with accumulated other comprehensive income (loss) as a separate component of shareholders’ equity. To date, cumulative translation adjustments have not been material to our consolidated financial position. However, future translation adjustments could materially and adversely affect us.

 

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Currently, there are no material exchange controls on the payment of dividends or otherwise prohibiting the transfer of funds out of or from within any country in which we conduct operations. Although we perform services for clients located in a number of foreign jurisdictions, we have not experienced any difficulties in receiving funds remitted from foreign countries. However, new or modified exchange control restrictions could have an adverse effect on our financial condition.

We are exposed to changes in interest rates on our cash, cash equivalents and short-term investments and amounts outstanding under notes payable and lines of credit. We invest our cash and cash equivalents in financial instruments with interest rates based on financial market conditions. We do not expect that a 10% change in interest rates in the future would have a material effect on our financial condition or results of operations.

 

Item 4. Controls and Procedures

Disclosure Controls and Procedures

Disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e)) are designed only to provide reasonable assurance that information to be disclosed in our Exchange Act Reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Accounting Officer (who is currently our principal financial officer), of the effectiveness of our disclosure controls and procedures pursuant to Exchange Act Rule 13a-15(b). Based upon that evaluation, our Chief Executive Officer and Chief Accounting Officer have concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report to provide the reasonable assurance discussed above.

Internal Control Over Financial Reporting

There were no changes in internal control over financial reporting during the second quarter of 2007 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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Part II. OTHER INFORMATION

 

Item 1. Legal Proceedings

In early 2007, we were named as a co-defendant in lawsuits alleging injuries to patients who took Sanofi-Aventis’ FDA-approved antibiotic Ketek, for which we provided certain clinical trial services. These lawsuits include: Campbell v. Sanofi-Aventis, et al. filed in the Circuit Court of Etowah County, Alabama; Gregg and Gregg v. Sanofi-Aventis, et al., Manley and Manley v. Sanofi-Aventis, et al., Bennett v. Sanofi-Aventis et al., Henry v. Sanofi-Aventis et al., and Hamm v. Sanofi-Aventis, et al., each filed in Superior Court of New Jersey, Middlesex County; and Carpenter v. Sanofi-Aventis, et al. filed in the Superior Court in Mecklenburg County, North Carolina. More similar suits are possible. These suits claim unspecified damages and allege multiple causes of action, including negligence, misrepresentation, breach of warranty, conspiracy, wrongful death in at least two cases and violations of various state and federal statutes, including unfair and deceptive trade practices acts. While there can be no assurance of a successful outcome and litigation costs can be material, we do not believe that they have merit and intend to vigorously defend ourself in these matters.

 

Item 4. Submission of Matters to a Vote of Security Holders

The 2007 Annual Meeting of Shareholders of the Company was held on May 16, 2007. At the Annual Meeting, the following directors were elected to office for the ensuing year and were approved by the following votes:

 

     For    Withheld          
Stuart Bondurant    91,728,394    7,470,402      
Fredric N. Eshelman    98,749,205    449,591      
Marye Anne Fox    98,584,535    614,261      
Frederick Frank    74,865,468    24,333,328      
David L. Grange    86,125,842    13,072,954      
Catherine M. Klema    81,296,505    17,902,291      
Terry Magnuson    98,730,105    468,691      
Ernest Mario    91,590,519    7,608,277      
John A. McNeill, Jr.    91,459,796    7,739,000      

 

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Item 6. Exhibits

 

(a) Exhibits

 

10.245   Fifth Amendment dated July 1, 2007 to Loan Agreement, between Pharmaceutical Product Development, Inc. and Bank of America, N.A.
31.1   Certification of the Chief Executive Officer pursuant to Rule 13a-14(a)
31.2   Certification of the Chief Accounting Officer pursuant to Rule 13a-14(a)
32.1   Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of The Sarbanes-Oxley Act of 2002 – Chief Executive Officer
32.2   Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of The Sarbanes-Oxley Act of 2002 – Chief Accounting Officer

 

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SIGNATURES

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

 

    PHARMACEUTICAL PRODUCT DEVELOPMENT, INC.
  (Registrant)
By  

/s/ Fredric N. Eshelman

  Chief Executive Officer
  (Principal Executive Officer)
By  

/s/ Peter Wilkinson

  Chief Accounting Officer
  (Principal Financial Officer)

Date: August 6, 2007

 

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