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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 March 31, 2005.

 

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)

 

3151 South Seventeenth Street

Wilmington, North Carolina

(Address of principal executive offices)

 

28412

(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 an accelerated filer (as defined in Rule 12b-2 of the Act).    Yes  x    No  ¨

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 56,850,581 shares of common stock, par value $0.10 per share, as of April 25, 2005.

 



Table of Contents

INDEX

 

     Page

Part I. FINANCIAL INFORMATION

    

Item 1. Financial Statements

    

Consolidated Condensed Statements of Operations for the Three Months Ended March 31, 2004 and 2005 (unaudited)

   3

Consolidated Condensed Balance Sheets as of December 31, 2004 and March 31, 2005 (unaudited)

   4

Consolidated Condensed Statements of Cash Flows for the Three Months Ended March 31, 2004 and 2005 (unaudited)

   5

Notes to Consolidated Condensed Financial Statements (unaudited)

   6

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

   20

Item 3. Quantitative and Qualitative Disclosures about Market Risk

   31

Item 4. Controls and Procedures

   33

Part II. OTHER INFORMATION

    

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
March 31,


 
     2004

   2005

 

Net Revenue:

               

Development revenue

   $ 174,714    $ 212,921  

Discovery sciences revenue

     7,548      12,860  

Reimbursed out-of-pockets

     13,018      18,273  
    

  


Total net revenue

     195,280      244,054  
    

  


Direct Costs:

               

Development

     88,210      108,330  

Discovery sciences

     1,566      1,765  

Reimbursable out-of-pocket expenses

     13,018      18,273  
    

  


Total direct costs

     102,794      128,368  
    

  


Research and development expenses

     1,286      8,821  

Selling, general and administrative expenses

     45,159      55,432  

Depreciation

     6,717      8,359  

Amortization

     325      288  

Gain on exchange of assets

     —        (5,144 )

Restructuring charges

     505      —    
    

  


Total operating expenses

     156,786      196,124  
    

  


Income from operations

     38,494      47,930  

Interest income, net

     192      1,275  

Other income, net

     312      (95 )
    

  


Income before provision for income taxes

     38,998      49,110  

Provision for income taxes

     14,234      13,489  
    

  


Net income

   $ 24,764    $ 35,621  
    

  


Net income per share:

               

Basic

   $ 0.44    $ 0.63  
    

  


Diluted

   $ 0.44    $ 0.62  
    

  


Weighted average number of common shares outstanding:

               

Basic

     56,155      56,758  

Dilutive effect of stock options

     434      771  
    

  


Diluted

     56,589      57,529  
    

  


 

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

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

 

CONSOLIDATED CONDENSED BALANCE SHEETS

 

(in thousands)

 

     December 31,
2004


   March 31,
2005


          (unaudited)
Assets              

Current assets

             

Cash and cash equivalents

   $ 144,348    $ 236,358

Short-term investments

     105,020      —  

Accounts receivable and unbilled services, net

     265,067      268,408

Income tax receivable

     6,321      —  

Investigator advances

     15,251      13,712

Prepaid expenses and other current assets

     28,189      26,782

Deferred tax asset

     10,867      11,597
    

  

Total current assets

     575,063      556,857

Property and equipment, net

     136,501      194,353

Goodwill

     179,781      211,300

Investments

     66,658      42,468

Intangible assets

     3,895      3,607

Other assets

     929      1,150

Long-term deferred tax asset

     12,374      9,065
    

  

Total assets

   $ 975,201    $ 1,018,800
    

  

Liabilities and Shareholders’ Equity              

Current liabilities

             

Accounts payable

   $ 12,863    $ 15,029

Payables to investigators

     43,726      49,847

Accrued income taxes

     5,118      12,822

Other accrued expenses

     101,714      95,047

Deferred tax liability

     770      76

Unearned income

     153,170      146,301

Current maturities of long-term debt and capital lease obligations

     599      2,028
    

  

Total current liabilities

     317,960      321,150

Long-term debt and capital lease obligations, less current maturities

     6,371      7,323

Deferred rent and other

     5,267      6,355

Accrued additional pension liability

     9,923      9,779

Long-term deferred tax liability

     370      1,108
    

  

Total liabilities

     339,891      345,715

Shareholders’ equity

             

Common stock

     5,662      5,681

Paid-in capital

     293,200      298,763

Retained earnings

     325,269      360,890

Accumulated other comprehensive income

     11,179      7,751
    

  

Total shareholders’ equity

     635,310      673,085
    

  

Total liabilities and shareholders’ equity

   $ 975,201    $ 1,018,800
    

  

 

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)

 

     Three Months Ended
March 31,


 
     2004

    2005

 

Cash flows from operating activities:

                

Net income

   $ 24,764     $ 35,621  

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

                

Depreciation and amortization

     7,042       8,647  

Restructuring charges

     505       —    

Gain on exchange of assets

     —         (5,144 )

Loss on disposition of property and equipment, net

     520       85  

Provision for doubtful accounts

     50       50  

(Benefit) provision for deferred income taxes

     (2,410 )     2,695  

Change in operating assets and liabilities, net of acquisitions

     405       5,458  
    


 


Net cash provided by operating activities

     30,876       47,412  
    


 


Cash flows from investing activities:

                

Purchases of property and equipment

     (13,256 )     (58,432 )

Proceeds from sale of property and equipment

     66       18  

Purchases of available–for-sale investments

     (182,864 )     (24,720 )

Maturities and sales of available-for-sale investments

     182,476       129,740  

Purchases of investments

     (5,900 )     (5,101 )

Cash refunded related to business acquired

     1,450       —    
    


 


Net cash (used in) provided by investing activities

     (18,028 )     41,505  
    


 


Cash flows from financing activities:

                

Principal repayments of long-term debt

     (85 )     (94 )

Repayment of capital leases obligation

     (308 )     (423 )

Proceeds from exercise of stock options and employee stock purchase plan

     3,636       4,835  
    


 


Net cash provided by financing activities

     3,243       4,318  
    


 


Effect of exchange rate changes on cash and cash equivalents

     467       (1,225 )
    


 


Net increase in cash and cash equivalents

     16,558       92,010  

Cash and cash equivalents, beginning of the period

     60,677       144,348  
    


 


Cash and cash equivalents, end of the period

   $ 77,235     $ 236,358  
    


 


 

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

 

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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. We prepared these unaudited consolidated condensed financial statements in accordance with Rule 10-01 of Regulation S-X and, in management’s opinion, we have 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, 2004. The results of operations for the three-month period ended March 31, 2005 are not necessarily indicative of the results to be expected for the full year or any other period. We derived the amounts on the December 31, 2004 consolidated condensed balance sheet from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2004.

 

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.

 

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.

 

Earnings per share

 

The computation of basic income per share information is based on the weighted average number of common shares outstanding during the period. The computation of diluted income per share information is based on the weighted average number of common shares outstanding during the period plus the effects of any dilutive common stock equivalents.

 

Reclassification

 

The Company has reclassified certain 2004 financial statement amounts to conform to the 2005 financial statement presentation.

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

 

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

 

(unaudited)

 

1. SIGNIFICANT ACCOUNTING POLICIES (continued)

 

Stock-based compensation

 

The Company has adopted the disclosure requirements of Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” and Statement of Financial Accounting Standards No. 148, “Accounting for Stock Based Compensation - Transition and Disclosure - an Amendment of FASB Statement No. 123”, which require compensation expense to be disclosed in the notes based on the fair value of the options granted at the date of the grant. Had compensation cost for the Company’s stock option plan been determined based on the fair value at the grant dates for awards under the plan consistent with the method required by SFAS No. 123, the Company’s net income and diluted net income per common share would have been the pro forma amounts indicated below.

 

     Three Months Ended
March 31,


 

(in thousands, except per share data)

 

   2004

    2005

 

Net income, as reported

   $ 24,764     $ 35,621  

Less: Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects

     (1,311 )     (2,740 )
    


 


Pro forma net income

   $ 23,453     $ 32,881  
    


 


Net income per share:

                

Basic – as reported

   $ 0.44     $ 0.63  

Basic – pro forma

   $ 0.42     $ 0.58  

Diluted – as reported

   $ 0.44     $ 0.62  

Diluted – pro forma

   $ 0.41     $ 0.57  

 

Restructuring charges

 

In the first and second quarter of 2004, the Company recorded a $0.5 million and a $2.1 million restructuring charge, respectively, associated with exiting the Company’s chemistry facility in Research Triangle Park, North Carolina. These charges include lease payments and termination costs, net of sublease rentals, of approximately $2.1 million and a loss on sale of assets used in the chemistry services business of approximately $0.5 million. The lease termination liability will be paid over the remaining life of the lease, which terminates in 2015. During the three months ended March 31, 2004 and 2005, lease payments and related expenses of $0 and $0.3 million were paid, respectively. At March 31, 2005, the Company recorded the remaining restructuring liability of $0.9 million in the consolidated condensed balance sheet as a component of other accrued expenses and deferred rent and other. The loss on sale of assets was a non-cash item and was charged to expense during the three months ended March 31, 2004.

 

Inventory

 

Inventories, which consist principally of laboratory supplies, are valued at the lower of cost (first-in, first-out method) or market. Inventories totaling $2.2 million and $2.4 million as of December 31, 2004 and March 31, 2005, respectively, were included in prepaid expenses and other current assets.

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

 

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

 

(unaudited)

 

1. SIGNIFICANT ACCOUNTING POLICIES (continued)

 

Recent accounting pronouncements

 

In November 2003, during discussions on Emerging Issues Task Force, or EITF 03-01, “The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments”, the EITF reached a consensus that requires quantitative and qualitative disclosures for debt and marketable equity securities classified as available-for-sale or held-to-maturity under SFAS No. 115 and SFAS No. 124 that are impaired at the balance sheet date but for which an other-than-temporary impairment has not been recognized. In September 2004, FASB Staff Position EITF Issue 03-1-1 was issued to delay the effective date for the measurement and recognition guidance. This delay does not suspend the requirement to recognize other-than-temporary impairments as required by existing authoritative literature. The Company has adopted the disclosure requirements of EITF 03-01.

 

In October 2004, the EITF finalized its consensuses on EITF 04-01, “Accounting for Preexisting Relationships between the Parties to a Business Combination”. The consensuses in EITF 04-01 provide guidance on how to account for the settlement of a preexisting relationship and how it affects the accounting of the business combination. EITF 04-01 is effective for business combinations consummated and goodwill impairment tests performed in reporting periods beginning after October 13, 2004. In February 2005, the Company recorded a gain on the termination of a preexisting lease arrangement as part of the acquisition of SurroMed, Inc.’s biomarker business in accordance with the guidance in EITF 04-01. See Note 2.

 

In December 2004, the FASB issued SFAS No. 123 (Revised 2004) “Share-Based Payment” that will require compensation costs related to share-based payment transactions to be recognized in the financial statements. With limited exceptions, the amount of compensation cost will be measured based on the fair value on the date of grant of the equity or liability instruments issued. In addition, liability instruments will be remeasured each reporting period. Compensation cost will be recognized over the period that an employee provides service in exchange for the award. In March 2005, the SEC issued Staff Accounting Bulletin 107 which describes the SEC staff’s expectations in determining the assumptions that underlie the fair value estimates and discusses the interaction of SFAS No. 123 (Revised) with certain existing SEC guidance. In April 2005, the SEC deferred the effective date for SFAS No. 123 (Revised) to the beginning of the first fiscal year that begins after June 15, 2005. The Company is currently evaluating the impact of the adoption of this statement on the