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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, 2003.

 

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: 55,717,761 shares of common stock, par value $0.10 per share, as of May 1, 2003.

 



Table of Contents

 

INDEX

 

    

Page


Part I. FINANCIAL INFORMATION

    

Item 1. Financial Statements

    

Consolidated Condensed Statements of Operations (unaudited) for the Three Months Ended March 31, 2002 and 2003

  

3

Consolidated Condensed Balance Sheets (unaudited) as of December 31, 2002 and March 31, 2003

  

4

Consolidated Condensed Statements of Cash Flows (unaudited) for the Three Months Ended March 31, 2002 and 2003

  

5

Notes to Consolidated Condensed Financial Statements

  

6

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

  

13

Item 3. Quantitative and Qualitative Disclosures about Market Risk

  

22

Item 4. Controls and Procedures

  

23

Part II. OTHER INFORMATION

    

Item 6. Exhibits and Reports on Form 8-K

  

24

Signatures

  

25

Certifications

  

26

 

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 amounts)

 

    

Three Months Ended March 31,


    

2002


    

2003


Development revenues

  

$

116,736

 

  

$

155,899

Discovery sciences revenues

  

 

5,379

 

  

 

3,095

Reimbursed out-of-pockets

  

 

8,468

 

  

 

10,883

    


  

Net revenue

  

 

130,583

 

  

 

169,877

    


  

Direct costs – Development

  

 

55,674

 

  

 

74,719

Direct costs – Discovery sciences

  

 

1,941

 

  

 

1,534

Reimbursable out-of-pocket expenses

  

 

8,468

 

  

 

10,883

Research and development

  

 

1,751

 

  

 

3,361

Selling, general and administrative expenses

  

 

35,635

 

  

 

39,763

Depreciation

  

 

5,366

 

  

 

6,917

Amortization

  

 

281

 

  

 

290

    


  

    

 

109,116

 

  

 

137,467

    


  

Operating income

  

 

21,467

 

  

 

32,410

Interest income, net

  

 

877

 

  

 

256

Impairment of investment

  

 

(32,006

)

  

 

—  

Other income, net

  

 

667

 

  

 

537

    


  

Income (loss) before provision for income taxes

  

 

(8,995

)

  

 

33,203

Provision for income taxes

  

 

6,480

 

  

 

12,036

    


  

Income (loss) before equity in net loss of investee

  

 

(15,475

)

  

 

21,167

Equity in net loss of investee, net of income taxes

  

 

92

 

  

 

—  

    


  

Net income (loss)

  

$

(15,567

)

  

$

21,167

    


  

Net income (loss) per share – basic and diluted

  

$

(0.29

)

  

$

0.38

    


  

Weighted average number of common shares outstanding:

               

Basic

  

 

53,212

 

  

 

55,561

Dilutive effect of stock options

  

 

—  

 

  

 

554

    


  

Diluted

  

 

53,212

 

  

 

56,115

    


  

 

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

 

3


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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

 

CONSOLIDATED CONDENSED BALANCE SHEETS

(in thousands)

 

    

December 31, 2002


    

March 31, 2003


 
           

(unaudited)

 

Assets

                 

Current assets

                 

Cash and cash equivalents

  

$

181,224

 

  

$

185,925

 

Accounts receivable and unbilled services, net

  

 

199,936

 

  

 

209,747

 

Investigator advances

  

 

6,300

 

  

 

6,929

 

Prepaid expenses and other current assets

  

 

13,676

 

  

 

15,156

 

Notes receivable

  

 

500

 

  

 

—  

 

Deferred tax asset

  

 

13,858

 

  

 

11,177

 

    


  


Total current assets

  

 

415,494

 

  

 

428,934

 

Property, plant and equipment, net

  

 

109,704

 

  

 

108,874

 

Investments

  

 

16,934

 

  

 

17,424

 

Goodwill

  

 

147,408

 

  

 

148,433

 

Intangible assets

  

 

1,624

 

  

 

1,338

 

Other assets, net

  

 

956

 

  

 

721

 

    


  


Total assets

  

$

692,120

 

  

$

705,724

 

    


  


Liabilities and Shareholders’ Equity

                 

Current liabilities

                 

Accounts payable

  

$

10,645

 

  

$

11,291

 

Payables to investigators

  

 

20,645

 

  

 

24,413

 

Other accrued expenses

  

 

68,026

 

  

 

53,215

 

Unearned income

  

 

114,494

 

  

 

109,280

 

Accrued income taxes

  

 

12,231

 

  

 

13,210

 

Current maturities of long-term debt

  

 

1,757

 

  

 

1,637

 

    


  


Total current liabilities

  

 

227,798

 

  

 

213,046

 

Long-term debt, less current maturities

  

 

6,649

 

  

 

6,409

 

Deferred rent and other

  

 

3,480

 

  

 

3,946

 

Accrued additional pension liability

  

 

7,905

 

  

 

7,761

 

Deferred tax liability, net

  

 

5,951

 

  

 

5,719

 

    


  


Total liabilities

  

 

251,783

 

  

 

236,881

 

    


  


Shareholders’ equity

                 

Common stock

  

 

5,544

 

  

 

5,571

 

Paid-in capital

  

 

263,554

 

  

 

268,818

 

Retained earnings

  

 

180,071

 

  

 

201,238

 

Deferred compensation

  

 

(367

)

  

 

(275

)

Accumulated other comprehensive loss

  

 

(8,465

)

  

 

(6,509

)

    


  


Total shareholders’ equity

  

 

440,337

 

  

 

468,843

 

    


  


Total liabilities and shareholders’ equity

  

$

692,120

 

  

$

705,724

 

    


  


 

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

 

4


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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

 

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

    

Three Months Ended

March 31,


 
    

2002


    

2003


 

Cash flows from operating activities:

                 

Net income (loss)

  

$

(15,567

)

  

$

21,167

 

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

                 

Impairment of investment

  

 

32,006

 

  

 

—  

 

Depreciation and amortization

  

 

5,647

 

  

 

7,207

 

Stock compensation amortization

  

 

121

 

  

 

92

 

Loss (gain) on disposition of property and equipment, net

  

 

12

 

  

 

(21

)

Provision for doubtful accounts

  

 

(100

)

  

 

118

 

Equity in net loss of investee

  

 

103

 

  

 

—  

 

Deferred income taxes

  

 

(2,881

)

  

 

2,448

 

Change in operating assets and liabilities, net of effect of acquisitions

  

 

5,937

 

  

 

(25,929

)

    


  


Net cash provided by operating activities

  

 

25,278

 

  

 

5,082

 

    


  


Cash flows from investing activities:

                 

Cash received from repayment of note receivable

  

 

500

 

  

 

500

 

Purchases of property and equipment

  

 

(10,526

)

  

 

(5,900

)

Proceeds from sale of property and equipment

  

 

4

 

  

 

34

 

Purchases of investments

  

 

(50

)

  

 

—  

 

Net cash paid for acquisitions

  

 

(29,103

)

  

 

—  

 

    


  


Net cash used in investing activities

  

 

(39,175

)

  

 

(5,366

)

    


  


Cash flows from financing activities:

                 

Principal repayments of long-term debt

  

 

—  

 

  

 

(69

)

Repayment of capital leases obligation

  

 

(396

)

  

 

(510

)

Proceeds from exercise of stock options and employee stock purchase plan

  

 

3,271

 

  

 

4,102

 

    


  


Net cash provided by financing activities

  

 

2,875

 

  

 

3,523

 

    


  


Effect of exchange rate changes on cash

  

 

(611

)

  

 

1,462

 

    


  


Net increase (decrease) in cash and cash equivalents

  

 

(11,633

)

  

 

4,701

 

Cash and cash equivalents, beginning of the period

  

 

143,173

 

  

 

181,224

 

    


  


Cash and cash equivalents, end of the period

  

$

131,540

 

  

$

185,925

 

    


  


 

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

 

5


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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

 

(unaudited)

(in thousands, except per share data)

 

1.   SIGNIFICANT ACCOUNTING POLICIES

 

The significant accounting policies followed by Pharmaceutical Product Development, Inc. and its subsidiaries (collectively “PPD” or 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 might not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements and should be read in conjunction with the consolidated financial statements and notes thereto in PPD’s Annual Report on Form 10-K for the year ended December 31, 2002. The results of operations for the three-month period ended March 31, 2003 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, 2002 consolidated condensed balance sheet from the audited financial statements included in PPD’s Annual Report on Form 10-K for the year ended December 31, 2002.

 

Use of Estimates in the Preparation of Financial Statements

 

The preparation of financial statements in conformity with generally accepted accounting principles 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 amounts could differ from those estimates.

 

Reclassifications

 

We have reclassified certain 2002 financial statement amounts to conform to the 2003 financial statement presentation.

 

Principles of consolidation

 

The accompanying unaudited consolidated condensed financial statements include the accounts and operations of PPD. We have eliminated all intercompany balances and transactions in consolidation.

 

Earnings per share

 

We compute basic net income (loss) per share information using the weighted average number of shares of common stock outstanding during the period. We compute diluted net income (loss) per common share using the weighted average number of shares of common and dilutive potential common shares outstanding during the period.

 

Stock-Based Compensation

 

The Company accounts for stock-based compensation based on the provisions of Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees”, or APB No. 25, which states that, for fixed plans, no compensation expense is recorded for stock options or other stock-based awards to employees that are granted with an exercise price equal to or above the estimated fair value per share of the Company’s common stock on the grant date. In the event that stock options are granted with an exercise price below the estimated fair value of the Company’s common stock at the grant date, the difference between the fair value of the Company’s common stock and the exercise price of the stock option is recorded as deferred compensation. Deferred compensation is amortized to compensation expense over the vesting period of the stock option. 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 requires compensation expense to be disclosed based on the fair value of the options granted at the date of the grant.

 

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

 

(unaudited)

(in thousands, except per share data)

 

1.   SIGNIFICANT ACCOUNTING POLICIES (continued)

 

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.

 

    

Quarters Ended March 31,


 
    

2002


    

2003


 

Net income (loss), as reported

  

$

(15,567

)

  

$

21,167

 

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

  

 

(1,170

)

  

 

(1,164

)

    


  


Pro forma net income (loss)

  

$

(16,737

)

  

$

20,003

 

    


  


Net income (loss) per share:

                 

Basic – as reported

  

$

(0.29

)

  

$

0.38

 

Basic – pro forma

  

$

(0.31

)

  

$

0.36

 

Diluted – as reported

  

$

(0.29

)

  

$

0.38

 

Diluted – pro forma

  

$

(0.31

)

  

$

0.36

 

 

Recent Accounting Pronouncements

 

In June 2001, the Financial Accounting Standards Board, or FASB, issued Statement of Financial Accounting Standards No. 143, “Accounting for Asset Retirement Obligations”, or SFAS No. 143, which addresses financial accounting and reporting for obligations associated with the retirement of tangible long-lived assets and the associated asset retirement costs. SFAS No. 143 requires that the fair value of a liability for an asset retirement obligation be recognized in the period in which it is incurred if a reasonable estimate of fair value can be made. The associated asset retirement costs are capitalized as part of the carrying amount of the long-lived asset. SFAS No. 143 is effective for financial statements issued for fiscal years beginning after June 15, 2002. The adoption of this statement did not have a material impact on our financial statements.

 

In November 2001, the FASB issued Emerging Issues Task Force Rule No. 01-14, or EITF 01-14, Income Statement Characterization of Reimbursements Received for “Out-of-Pocket” Expenses Incurred. EITF 01-14 requires that in cases where the contractor acts as a principal, reimbursements received for out-of-pocket expenses incurred be characterized as revenue and the associated costs included as operating expenses in the income statement. The implementation of this rule resulted only in the gross-up of revenues and expenses and had no impact upon earnings. PPD pays, on behalf of its customers, fees to investigators and test subjects, and other out-of-pocket costs, such as travel, printing, meetings, couriers, etc., for which PPD is reimbursed at cost, without mark-up or profit. PPD will continue to exclude from revenue and expense in the income statement fees and associated reimbursements that we receive as an agent. During the three months ended March 31, 2002 and 2003, fees paid to investigators and other fees that PPD received as an agent and the associated reimbursements were approximately $33.8 million and $44.6 million, respectively.

 

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Table of Contents

 

PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

 

(unaudited)

(in thousands, except per share data)

 

1.   SIGNIFICANT ACCOUNTING POLICIES (continued)

 

In November 2002, the Emerging Issues Task Force, or EITF, of the FASB finalized its tentative consensus on EITF Issue 00-21, “Revenue Arrangements with Multiple Deliverables”, which provides guidance on the timing and method of revenue recognition for sales arrangements that include the delivery of more than one product or service. EITF 00-21 is effective prospectively for arrangements entered into in fiscal periods beginning after June 15, 2003. The Company is currently evaluating the impact of the adoption of this consensus on the Company’s financial statements.

 

In November 2002, the FASB issued Financial Accounting Standards Board Interpretation No. 45, or FIN 45, “Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others, an interpretation of FASB Statement Nos. 5, 57, and 107 and Rescission of FASB Interpretation No. 34.” FIN 45 clarifies the requirements of FASB Statement No. 5, “Accounting for Contingencies,” relating to the guarantor’s accounting for, and disclosure of, the issuance of certain types of guarantees. FIN 45 requires that upon issuance of a guarantee, the guarantor must recognize a liability for the fair value of the obligation it assumes under that guarantee. The disclosure provisions of FIN 45 are effective for financial statements of interim or annual periods that end after December 15, 2002. FIN 45’s provisions for initial recognition and measurement should be applied on a prospective basis to guarantees issued or modified after December 31, 2002, irrespective of the guarantor’s fiscal year-end. The guarantor’s previous accounting for guarantees that were issued before the date of FIN 45’s initial application may not be revised or restated to reflect the effect of the recognition and measurement provisions of FIN 45. The adoption of this statement did not have a material impact on the Company’s financial statements.

 

In December 2002, the FASB issued SFAS No. 148, “Accounting for Stock-Based Compensation – Transition and Disclosure – an Amendment of FASB Statement No. 123.” This Statement amends SFAS No. 123, “Accounting for Stock-Based Compensation”, to provide alternative methods of transition for a voluntary change to the fair value based method of accounting for stock-based employee compensation. In addition, this statement amends the disclosure requirements of SFAS No. 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock-based employee compensation and the effect of the method used on reported results. This statement requires that companies having a year-end after December 15, 2002 follow the prescribed format and provide the additional disclosures in their annual reports. The adoption of this statement did not have a material impact on the Company’s financial statements.

 

2.   GOODWILL AND INTANGIBLE ASSETS

 

In July 2001, the FASB issued Statement of Financial Accounting Standards No. 141, “Business Combinations”, which eliminated the pooling of interests method of accounting for all business combinations initiated after June 30, 2001 and addresses the initial recognition and measurement of goodwill and other intangible assets acquired in a business combination. In July 2001, the FASB issued Statement of Financial Accounting Standards No. 142, “Goodwill and Other Intangible Assets”, or SFAS No. 142. PPD adopted SFAS No. 142 as of January 1, 2002. SFAS No. 142 addresses the financial accounting and reporting standards for the acquisition of intangible assets outside of a business combination, and for goodwill and other intangible assets subsequent to their acquisition. This accounting standard requires that goodwill be separately disclosed from other intangible assets in the statement of financial position, and no longer be amortized but tested for impairment on a periodic basis. The provisions of this accounting standard also require the completion of a transitional impairment test within six months of adoption. PPD has completed the transitional impairment test as of January 1, 2002 and the annual impairment test as of October 1, 2002 and did not identify any impairments of goodwill. These tests involved determining the fair market value of each of the reporting units with which the goodwill was associated and comparing the estimated fair market value of each of the reporting units with its carrying amount. Additionally, SFAS No. 142 requires intangible assets that do not meet the criteria for recognition apart from goodwill to be reclassified. As a result of PPD’s analysis, no reclassifications to goodwill were required as of January 1, 2002.

 

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

 

(unaudited)

(in thousands, except per share data)

 

2.   GOODWILL AND INTANGIBLE ASSETS (continued)

 

Changes in the carrying amount of goodwill for the twelve months ended December 31, 2002 and the quarter ended March 31, 2003, by operating segment, were as follows:

 

    

Development


  

Discovery


  

Total


Balance as of January 1, 2002

  

$

6,839

  

$

751

  

$

7,590

Goodwill recorded during the period

  

 

116,814

  

 

19,721

  

 

136,535

Translation adjustments

  

 

3,283

  

 

—  

  

 

3,283

    

  

  

Balance as of December 31, 2002

  

$

126,936

  

$

20,472

  

$

147,408

    

  

  

 

    

Development


  

Discovery


  

Total


Balance as of January 1, 2003

  

$

126,936

  

$

20,472

  

$

147,408

Goodwill recorded during the period

  

 

122

  

 

143

  

 

265

Translation adjustments

  

 

760

  

 

—  

  

 

760

    

  

  

Balance as of March 31, 2003

  

$

127,818

  

$

20,615

  

$

148,433

    

  

  

 

Information regarding PPD’s other intangible assets follows:

 

    

As of December 31, 2002


  

As of March 31, 2003


    

Carrying

Amount


  

Accumulated

Amortization


  

Net


  

Carrying

Amount


  

Accumulated

Amortization


  

Net


Backlog

  

$

2,100

  

$

919

  

$

1,181

  

$

2,100

  

$

1,181

  

$

919

Patents

  

 

280

  

 

192

  

 

88

  

 

280

  

 

203

  

 

77

License agreements

  

 

500

  

 

145

  

 

355

  

 

500

  

 

158

  

 

342

Miscellaneous intangible assets

  

 

915

  

 

915

  

 

—  

  

 

961

  

 

961

  

 

—  

    

  

  

  

  

  

Total

  

$

3,795

  

$

2,171

  

$

1,624

  

$

3,841

  

$

2,503

  

$

1,338

    

  

  

  

  

  

 

All intangible assets are amortized on a straight-line basis, based on estimated useful lives of two years for backlog, five years for patents, ten years for license agreements and two to ten years for miscellaneous intangible assets. The weighted average amortization period for all intangibles is approximately 2.5 years.

 

3.   ACQUISITIONS

 

In February 2002, PPD acquired 100% of the outstanding common stock of Medical Research Laboratories International, Inc. (“MRL U.S.”) and Medical Research Laboratories International, BVBA (“MRL Belgium”), collectively, “MRL”. MRL is now part of the Development segment of PPD. MRL U.S. operates a central laboratory in Highland Heights, Kentucky, near Cincinnati, Ohio, and MRL Belgium operates a central laboratory in Brussels, Belgium. MRL provides highly standardized efficacy and safety testing services for pharmaceutical companies engaged in clinical drug development and is one of the largest central laboratory providers for Phase I-IV global studies involving agents used in cholesterol, endocrine, metabolic and cardiovascular clinical research. The results of operations are included in PPD’s condensed consolidated results of operations as of and since February 19, 2002, the effective date of the acquisition. PPD acquired MRL for total consideration of $113.1 million, including $39.0 million in cash, $73.5 million in PPD’s common stock (approximately 2.6 million unregistered shares) and direct acquisition costs of $0.6 million for legal, appraisal and accounting fees.

 

9


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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

 

(unaudited)

(in thousands, except per share data)

 

3.   ACQUISITIONS (continued)

 

In April 2002, PPD acquired Piedmont Research Center II, Inc, or PRC, a research laboratory based in Morrisville, North Carolina. that performs preclinical evaluations of anti-cancer therapies for national and international pharmaceutical and biotechnology companies. PRC is now part of the Discovery segment of PPD. The results of operations are included in PPD’s condensed consolidated results of operations as of and since April 1, 2002, the effective date of the acquisition. PPD acquired PRC for total consideration of $19.6 million, including $2.4 million in cash, $17.1 million in PPD’s common stock (0.5 million unregistered shares) and direct acquisition costs of $0.1 million for legal and accounting fees.

 

In June 2002, PPD acquired Complete Software Solutions, Inc., or CSS, a technical consulting firm offering implementation, validation and training services as well as specialized software for pharmaceutical and biotechnology industries. CSS is now part of the Development segment of PPD. The results of operations are included in PPD’s condensed consolidated results of operations as of and since June 12, 2002, the effective date of the acquisition. PPD acquired CSS for total consideration of $16.8 million in cash.

 

In June 2002, PPD acquired ProPharma Pte Ltd, an Asian-based clinical research organization with experience in managing pan-Asian clinical trials. ProPharma is now part of the Development segment of PPD. The results of operations are included in PPD’s condensed consolidated results of operations as of and since June 27, 2002, the effective date of the acquisition. PPD acquired ProPharma for total consideration of $3.0 million in cash. In addition, PPD agreed to pay up to $1.4 million as additional purchase price, depending upon the financial performance of ProPharma for a specified period following the acquisition.

 

These acquisitions were accounted for using the purchase method, utilizing appropriate fair value techniques to allocate the purchase price based on the estimated fair values of the assets and liabilities. Accordingly, the estimated fair value of assets acquired and liabilities assumed were included in PPD’s condensed consolidated balance sheet as of the effective date of the acquisitions.

 

The total purchase price was allocated to the estimated fair value of assets acquired and liabilities assumed as set forth in the following table:

 

    

MRL


    

PRC


    

CSS


    

ProPharma


    

Total


 

Condensed balance sheet:

                                            

Current assets

  

$

16,020

 

  

$

803

 

  

$

945

 

  

$

1,023

 

  

$

18,791

 

Property and equipment, net

  

 

8,308

 

  

 

822

 

  

 

34

 

  

 

116

 

  

 

9,280

 

Current liabilities

  

 

(7,814

)

  

 

(1,367

)

  

 

(870

)

  

 

(252

)

  

 

(10,303

)

Long-term capital lease obligation

  

 

(1,107

)

  

 

(457

)

  

 

—  

 

  

 

—  

 

  

 

(1,564

)

Deferred tax liability

  

 

(2,553

)

  

 

(4

)

  

 

—  

 

  

 

—  

 

  

 

(2,557

)

Value of identifiable intangible assets:

                                            

Backlog

  

 

2,100

 

  

 

—  

 

  

 

—  

 

  

 

—  

 

  

 

2,100

 

Goodwill

  

 

98,165

 

  

 

19,864

 

  

 

16,657

 

  

 

2,113

 

  

 

136,799

 

    


  


  


  


  


Total

  

$

113,119

 

  

$

19,661

 

  

$

16,766

 

  

$

3,000

 

  

$

152,546

 

    


  


  


  


  


 

Initially, the purchase price allocations for the acquisitions are based on preliminary estimates, using available information and making assumptions management believes are reasonable. Accordingly, purchase price allocations are subject to finalization within one year of the acquisition. The purchase price allocations for MRL and PRC have been finalized as of March 31, 2003. Goodwill will be evaluated annually as required by SFAS 142.

 

Goodwill related to MRL, PRC and ProPharma is not expected to be deductible for tax purposes. Goodwill related to CSS is expected to be deductible for tax purposes.

 

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

 

(unaudited)

(in thousands, except per share data)

 

4.   COMPREHENSIVE INCOME

 

PPD’s total comprehensive income (loss) for the three-month periods ended March 31, 2002 and 2003 was $(16,175) and $23,119, respectively. PPD’s other comprehensive income consisted of a change in the cumulative translation adjustment for the three-month periods ended March 31, 2002 and 2003 of $(608) and $1,462, respectively, and an unrealized gain on investment of $490 for the 2003 period.

 

5.   ACCOUNTS RECEIVABLE AND UNBILLED SERVICES

 

Accounts receivable and unbilled services consisted of the following:

 

    

December 31,

2002


    

March 31, 2003


 
           

(unaudited)

 

Billed

  

$

130,865

 

  

$

143,029

 

Unbilled

  

 

72,692

 

  

 

69,986

 

Reserve for doubtful accounts

  

 

(3,621

)

  

 

(3,268

)

    


  


    

$

199,936

 

  

$

209,747

 

    


  


 

6.   INVESTMENTS

 

PPD assesses its investment portfolio on a quarterly basis to determine whether declines in the market value of these securities are other than temporary. This quarterly review includes an evaluation of, among other things, the market condition of the overall industry, historical and projected financial performance, expected cash needs and recent funding events. As a result of management’s quarterly evaluations, during the three months ended March 31, 2002, PPD recorded a charge to earnings for an other than temporary decline in the fair market value of its investment in DNA Sciences of approximately $32.0 million. The investment in DNA Sciences was deemed to be impaired as a result of adverse events experienced by DNA Sciences during the first quarter of 2002.

 

In April 2002, PPD purchased 1.0 million shares of SurroMed, Inc. Series E preferred stock for $5.0 million, which represented a 2.7% ownership interest in SurroMed as of April 2002. SurroMed is a privately held company that has developed a proprietary technology for biological markers.

 

In April 2002, Apothogen, Inc., an equity method investment of PPD, was acquired by IntraBiotics Pharmaceuticals, Inc. As a result of the acquisition, PPD received shares of IntraBiotics common stock representing less than a 1.0% ownership interest in IntraBiotics outstanding common stock. In connection with the acquisition, the contracts and commitments between Apothogen and its stockholders related to the initial investment were terminated. Following the acquisition, IntraBiotics continued to rent facility space from PPD and PPD provided Intrabiotics with specified drug development and administrative services. During the fourth quarter of 2002, the Company recorded a charge to earnings for an other than temporary decline in the fair market value of its investment in IntraBiotics of approximately $0.3 million. PPD no longer leases facility space to IntraBiotics and has ceased providing IntraBiotics with drug development and administrative services.

 

 

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PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

 

(unaudited)

(in thousands, except per share data)

 

6.   INVESTMENTS (continued)

 

In June 2002, PPD purchased approximately 0.7 million units of BioDelivery Sciences International, Inc. for $3.6 million. Each unit consisted of one share of common stock and one warrant for common stock. PPD’s common stock in BioDelivery Sciences International represented a 9.9% ownership interest in BioDelivery Sciences International’s outstanding common stock as of March 31, 2003. BioDelivery Sciences International is a publicly traded company that is developing and seeking to commercialize a drug delivery technology designed for a potentially broad base of pharmaceuticals, vaccines and over-the-counter drugs. The Company records an unrealized gain or loss related to this investment at the end of each quarter based on the closing price of this investment at the end of each period. As of March 31, 2003, the Company had recorded an unrealized loss of $1,449 related to this investment.

 

In December 2002, the Company purchased 150 thousand shares of Oriel Therapeutics, Inc. Series A convertible preferred stock for $150 thousand, which represented a 4.3% ownership interest in Oriel Therapeutics as of December 31, 2002. The Company also received, as part of the purchase, a warrant to purchase an equal number of shares of stock offered by Oriel Therapeutics in its next round of financing at a discount. In April 2003, the Company exercised these warrants to purchase 150 thousand shares of Oriel Therapeutics Series B convertible preferred stock for $240 thousand. At the same time, the Company also purchased an additional 255 thousand shares of Oriel’s Series B convertible preferred stock for $510 thousand. As of April 30, 2003, the Company owned 13.1% of Oriel’s outstanding capital stock. Oriel Therapeutics Corp. is a privately held company pursuing the development of technology to improve drug delivery in the treatment of respiratory and pulmonary diseases.

 

7.   BUSINESS SEGMENT DATA

 

Revenues by principal business segment are separately stated in the consolidated financial statements. PPD has changed its measurement of segment profitability from net income to income (loss) from operations in order to more accurately reflect the information used by PPD’s chief operating decision-maker. Income from operations and identifiable assets by principal business segment were as follows:

 

    

Three Months Ended March 31,


 
    

2002


    

2003


 

Income (loss) from operations:

                 

Development

  

$

21,513

 

  

$

36,813

 

Discovery sciences

  

 

(46

)

  

 

(4,403

)

    


  


Total

  

$

21,467

 

  

$

32,410

 

    


  


    

December 31,

2002


  

March 31, 2003


Identifiable assets:

             

Development

  

$

637,660

  

$

654,320

Discovery sciences

  

 

54,460

  

 

51,404

    

  

Total

  

$

692,120

  

$

705,724

    

  

8   SUBSEQUENT EVENTS

 

In April 2003, PPD purchased 2.0 million shares of Chemokine Therapeutics Corp. Series A convertible preferred stock for $2.7 million, which represents a 17.8% interest in the outstanding stock of Chemokine as of April 2003. Chemokine is a privately held company focusing on the development of peptide and small molecule therapeutics that are agonists or antagonists of chemokine activity. Chemokines are small proteins that recruit cells to local sites of infection. In particular, chemokine-based therapeutics are useful as either blood recovery agents or anti-metastasis agents.

 

 

 

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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, the 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 performances, 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 which could be inaccurate and which 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”. 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. We generally undertake no obligation to update publicly any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.

 

Company Overview

 

We are a leading global provider of drug discovery and development services to pharmaceutical and biotechnology companies. Our corporate mission is to help clients maximize the return on their research and development investments. We offer therapeutic expertise, advanced technologies and extensive resources for both drug discovery and drug development.

 

We have been in the drug development business for more than 17 years. Our development services include preclinical programs and Phase 1 to Phase 4 clinical development. We have extensive clinical trial experience across a multitude of therapeutic areas and parts of the world, including regional, national and global studies. In addition, we also offer post-market support services for drugs that have received approval for market use, such as product launch services, patient compliance programs, and medical communications programs for consumer and healthcare providers on product use and adverse events.

 

With more than 5,500 professionals worldwide, we have provided services to 41 of the top 50 pharmaceutical companies in the world as ranked by 2001 healthcare research and development spending, in addition to our work with leading biotechnology companies. We believe that we are one of the world’s largest providers of drug development services to pharmaceutical and biotechnology companies based on 2002 annual net revenues generated from contract research organizations.

 

Building on our outsourcing relationship with pharmaceutical and biotechnology clients, we established our discovery services group in 1997. This business focuses on early stage research to help our customers address the bottleneck at the beginning of the development process. The business primarily involves functional genomics, which is the study of gene functions to identify drug targets within the body, medicinal chemistry research and preclinical biology services, as well as preclinical evaluations of anticancer therapies.

 

In addition, we have developed an innovative risk-sharing research and development model to help pharmaceutical and biotechnology clients develop compounds. Through arrangements based on this model, we help our clients research and evaluate the development potential for early stage compounds, while their investment is significantly less than the amount at risk later.

 

 

 

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We believe that our integrated drug discovery and development services offer our clients a way to identify and develop successful drugs more quickly and cost effectively. We also use our proprietary informatics technology to support our drug discovery and development services. In addition, because we are positioned globally, we are able to accommodate the multinational drug discovery and development needs of our customers. As a result of having these core areas of expertise in discovery and development, we can provide integrated services across the entire drug development spectrum, from target discovery to market and beyond. For more detailed information on PPD, see our Annual Report on Form 10-K for the year ended December 31, 2002.

 

Results of Operations

 

We recognize revenues from fixed-price contracts on a proportional performance basis in our Development Group. To measure the performance, we compare actual direct costs incurred to estimated total contract direct costs, which is the best indicator of the performance of the contractual obligations as the costs relate to the labor hours incurred to perform the service. We recognize revenues from time-and-materials contracts as hours are incurred, multiplied by the billable rates for each contract in both our Development Group and Discovery Sciences Group. For our Phase 1 and laboratory businesses, we also recognize revenues from unitized contracts as subjects or samples are tested, multiplied by the price of each.

 

In connection with the management of multi-site clinical trials, we pay on behalf of our customers fees to investigators and test subjects, and other out-of-pocket costs, such as travel, printing, meetings, and couriers, for which we are reimbursed at cost. Effective January 1, 2002, in connection with the required implementation of EITF 01-14, amounts paid by us as a principal for out-of-pocket costs are now included in direct costs, while the reimbursements we receive as a principal are reported as reimbursed out-of-pocket revenues in the income statement. We are required to continue to net revenue and expense in the income statement from fees and associated reimbursements that we receive as an agent.

 

Most contracts are terminable either immediately or after a specified period following notice by the client. These contracts typically require payment to us of expenses to wind down a study, payment to us of fees earned to date, and in some cases, a termination fee or some portion of the fees or profit that we could have earned under the contract of it had not been terminated early.

 

Discovery Sciences Group revenues also include nonrefundable technology license fees and milestone payments. The non-refundable license fees are generally up-front payments for the initial license of and access to our technology. For nonrefundable license fees received at the initiation of license agreements for which we have an ongoing research and development commitment, we defer these fees and recognize them ratably over the period of the related research and development. For nonrefundable license fees received under license agreements where our continued performance of future research and development services is not required, we recognize revenue upon delivery of the technology. In addition to license fees, our Discovery Sciences Group also generates revenue from time to time in the form of milestone payments. Milestone payments are only received and recognized as revenues if the specified milestone is achieved and accepted by the customer and continued performance of future research and development services related to that milestone are not required. Although these payments are typically lower than up-front license fees, these payments can be significant because they are triggered as a result of achieving specified scientific milestones. We receive milestone payments in connection with sublicensing of compounds and in association with our target validation work.

 

We record our recurring operating expenses among five categories:

 

    direct costs, including reimbursable out-of-pocket expenses;

 

    research and development;

 

    selling, general and administrative;

 

    depreciation; and

 

    amortization.

 

Direct costs consist of appropriate 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 revenues, 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 conducted during any period of time.

 

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Table of Contents

 

Research and development, or R&D, expenses consist primarily of labor and related benefit charges associated with personnel performing internal research and development work, supplies associated with this work 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, administrative travel, an allocation of facility and information technology costs and costs related to professionals working in an indirect capacity.

 

Depreciation expenses consist of depreciation costs recorded on a straight-line method, based on estimated useful lives of 40 to 50 years for buildings, five years for laboratory equipment, three years for computers and related equipment and four to 10 years for furniture and equipment, except for our airplane, which we are depreciating over 30 years. Leasehold improvements are depreciated over the shorter of the respective lives of the leases or the useful lives of the improvements. Property under capital leases is depreciated over the life of the lease or the service life, whichever is shorter.

 

Amortization expenses consist of amortization costs recorded on intangible assets on a straight-line method over the life of the intangible assets. The excess of the purchase price of a business acquired over the fair value of net tangible assets, identifiable intangible assets and acquired in-process research and development costs at the date of the acquisition has been assigned to goodwill. Goodwill was being amortized over periods of 10 to 25 years prior to January 1, 2002. In July 2001, the FASB issued Statement of Financial Accounting Standards No. 142, “Goodwill and Other Intangible Assets”, or SFAS No. 142. We adopted SFAS No. 142 as of January 1, 2002 and no longer amortize goodwill. The provisions of this accounting standard also require the completion of a transitional impairment test within six months of adoption. We completed the transitional impairment test as of January 1, 2002 and the annual impairment test as of October 1, 2002 and did not identify any impairments of goodwill. These tests involved determining the fair market value of each of the reporting units with which the goodwill was associated and comparing the estimated fair market value of each of the reporting units with its carrying amount.

 

Acquisitions

 

In February 2002, PPD acquired 100% of the outstanding common stock of Medical Research Laboratories International, Inc. (“MRL U.S.”) and Medical Research Laboratories International, BVBA (“MRL Belgium”), collectively, “MRL”. MRL is now part of the Development segment of PPD. MRL U.S. operates a central laboratory near Cincinnati, Ohio, and MRL Belgium operates a central laboratory in Brussels, Belgium. MRL provides highly standardized efficacy and safety testing services for pharmaceutical companies engaged in clinical drug development. PPD acquired MRL for total consideration of $113.1 million, including $39.0 million in cash, $73.5 million in PPD’s common stock (approximately 2.6 million unregistered shares) and direct acquisition costs of $0.6 million for legal, appraisal and accounting fees.

 

In April 2002, PPD acquired Piedmont Research Center II, Inc, or PRC, a research laboratory based in Morrisville, North Carolina that performs preclinical evaluations of anti-cancer therapies for national and international pharmaceutical and biotechnology companies. PRC is now part of the Discovery segment of PPD. PPD acquired PRC for total consideration of $19.6 million, including $2.4 million in cash, $17.1 million in PPD’s common stock (0.5 million unregistered shares) and direct acquisition costs of $0.1 million for legal and accounting fees.

 

In June 2002, PPD acquired Complete Software Solutions, Inc., or CSS, a technical consulting firm offering a full range of implementation, validation and training services as well as specialized software for pharmaceutical and biotechnology industries. CSS is now part of the Development segment of PPD. PPD acquired CSS for total consideration of $16.8 million in cash.

 

In June 2002, PPD acquired ProPharma Pte Ltd, an Asian-based clinical research organization with extensive experience in managing pan-Asian clinical trials. ProPharma is now part of the Development segment of PPD. PPD acquired ProPharma for total consideration of $3.0 million in cash. In addition, PPD agreed to pay up to $1.4 million as additional purchase price, depending upon the financial performance of ProPharma for a specified period following the acquisition.

 

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Table of Contents

 

These acquisitions were accounted for using the purchase method, utilizing appropriate fair value techniques to allocate the purchase price based on the estimated fair values of the assets and liabilities. Accordingly, the estimated fair value of assets acquired and liabilities assumed were included in PPD’s condensed consolidated balance sheet as of the effective date of the acquisitions. The results of operations are included in PPD’s condensed consolidated results of operations as of and since the effective dates of the acquisitions. For further details regarding these acquisitions, see Note 3 to Consolidated Condensed Financial Statements.

 

Non-GAAP Information

 

The following discussion of our results of operations for the periods ended March 31, 2003 and 2002 and our financial condition as of March 31, 2003 includes non-GAAP financial measures. In the discussion, we sometimes exclude revenue and costs related to reimbursable out-of-pocket expenses because they are not generated by services we provide, do not yield any gross profit to us, and do not have any impact on our net income. We also sometimes exclude amounts associated with the impairments of our equity investments to more accurately reflect the results of our operations and provide similar information for period to period comparisons. We believe this information is useful to our investors because it presents the revenue and expenses that are directly attributable to the services we provide our clients and presents a more accurate picture of our operating results and margins.

 

Three Months Ended March 31, 2003 Versus Three Months Ended March 31, 2002

 

Net revenue for the three months ended March 31, 2003 increased $39.3 million, or 30.1%, to $169.9 million from net revenue of $130.6 million in the same period in 2002. Net revenue, before reimbursed out-of-pockets of $10.9 million for the first quarter of 2003, increased $36.9 million, or 30.2%, to $159.0 million from net revenue, before reimbursed out-of-pockets of $8.5 million, of $122.1 million in the same period in 2002. The Development Group’s operations accounted for 91.8% of net revenue for the first quarter of 2003. Excluding reimbursed out-of-pockets, the Development Group’s operations accounted for 98.1% of net revenue for the first quarter of 2003. The Development Group generated net revenue of $155.9 million in the first quarter of 2003, an increase of $39.2 million, or 33.5%, from the 2002 first quarter. The increase in the Development Group’s net revenue was primarily attributable to an increase in the size and number of contracts in the global contract research organization, or CRO, Phase 2 through 4 division.

 

The Discovery Sciences Group generated net revenue of $3.1 million in the first quarter of 2003, a decrease of $2.2 million, or 42.4%, from the first quarter of 2002. The decrease in the Discovery Sciences net revenue was attributable to the loss of revenue within our target validation group. The target validation group received payments in the first quarter of 2002 attributable to contracts that were not renewed.

 

Total direct costs for the first quarter of 2003 were $87.1 million, an increase of 31.9% from $66.1 million in the first quarter of 2002. As a percentage of net revenue, total direct costs increased slightly to 51.3% in the first quarter of 2003 as compared to 50.6% in the first quarter of 2002. Total direct costs, excluding reimbursable out-of-pocket expenses for the quarters ended March 31, 2003 and 2002 of $10.9 million and $8.5 million respectively, increased 32.3% to $76.3 million in the first quarter of 2003 from $57.6 million in the first quarter of 2002. Excluding reimbursable out of-pocket expenses, total direct costs increased slightly as a percentage of net revenue to 48.0% for 2003 first quarter as compared to 47.2% in 2002 first quarter. Development direct costs increased to $74.7 million in the first quarter of 2003 as compared to $55.7 million in the first quarter of 2002. This 34.1% increase resulted primarily from increased personnel costs due to the increase in the size and number of contracts in the global CRO Phase 2 through 4 division and the direct costs associated with the acquisitions completed during 2002. Development Group direct costs increased as a percentage of related net revenue to 48.0% in the first quarter of 2003 from 47.7% in the first quarter of 2002. This increase was principally due to the mix of levels of personnel involved in the contracts performed, variations in the utilization of personnel and the mix of contracts being performed during each quarter. Discovery Sciences direct costs decreased to $1.5 million in the first quarter of 2003 as compared to $1.9 million in the first quarter of 2002. This slight decrease was attributable to a decrease in direct costs related to revenue from payments made in the first quarter of 2002 to our target validation group for contracts that were not renewed, and offset by the direct costs generated from PRC for the three months ended March 31, 2003.

 

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Table of Contents

 

R&D expenses increased 92.0% to $3.4 million in the first quarter of 2003 from $1.8 million in the first quarter of 2002. This increase was primarily attributable to an increase in spending on internal R&D in the Discovery Sciences Group to develop intellectual property. As of the end of the first quarter of 2003, the Discovery Sciences Group had increased the number of employees working on internal R&D projects by 42% as compared to the end of the first quarter of 2002. Internal R&D spending continues to increase in both target validation and the chemistry GGTase programs.

 

SG&A expenses increased 11.6% to $39.8 million in the first quarter of 2003 from $35.6 million in the first quarter of 2002. The increase was primarily attributable to additional administrative personnel costs and an increase in training costs associated with new operational employees hired to support our expanding operations. As a percentage of net revenue, SG&A expenses decreased to 23.4% in the first quarter of 2003 from 27.3% in the first quarter of 2002. Excluding reimbursed out-of-pockets for the first quarters of 2003 and 2002 of $10.9 million and $8.5 million, respectively, SG&A expenses as a percent of net revenue decreased to 25.0% in the first quarter of 2003 from 29.2% in the first quarter of 2002. These decreases in SG&A expenses as a percentage of net revenue are primarily attributable to the increase in revenue, and to a smaller extent, to increased efficiencies as our operations expanded.

 

Depreciation expense increased $1.5 million, or 28.9%, to $6.9 million in the first quarter of 2003 from $5.4 million in the first quarter of 2002. The increase was primarily related to the depreciation of the increased investment in property and equipment due to our growth. Capital expenditures were $5.9 million in the first quarter of 2003. Capital expenditures primarily included additional spending in the Development Group on equipment, information technology licenses, furniture and computer hardware for new employees.

 

Amortization expense was approximately $0.3 million for the first quarter of 2003 and the first quarter of 2002. During the first quarter of 2002 and 2003, amortization of backlog associated with the acquisition of MRL accounted for $0.25 million and $0.26 million of the amortization expense, respectively.

 

Operating income increased $10.9 million to $32.4 million in the first quarter of 2003, as compared to $21.5 million in the first quarter of 2002. As a percentage of net revenue, operating income increased to 19.1% for the first quarter of 2003 from 16.4% in the first quarter of 2002. Excluding reimbursed out-of-pockets for the quarters ended March 31, 2003 and 2002 of $10.8 million and $8.5 million, respectively, operating income increased to 20.4% of net revenue for the first quarter of 2003 from 17.6% of net revenue in the same period of 2002. The increases in operating income and operating margin were primarily due to our revenue growth and our focus on controlling the increase in both direct and administrative costs.

 

During the first quarter of 2002, we recorded a $32.0 million write-down of the carrying value of our investment in DNA Sciences, Inc. for an other than temporary decline in value. Our investment in DNA Sciences was deemed to be impaired as a result of historical and projected performance, cash needs and an independent valuation of the market value of DNA Sciences.

 

Our provision for income taxes increased $5.6 million, or 85.7%, to $12.0 million in the first quarter of 2003, as compared to $6.5 million in the first quarter of 2002. During the first quarter of 2002, we recorded an impairment of $32.0 million in our investment in DNA Sciences. As a result of the uncertainty of the utilization of the deduction of the impairment prior to its expiration, we recorded a valuation allowance of $10.7 million, thus providing only a tax benefit of $2.0 million in the provision for income taxes.

 

Net income of $21.2 million in the first quarter of 2003 represents an increase of $36.8 million from $15.6 million in net loss in the first quarter of 2002, which loss included a $32.0 million impairment in our equity investment in DNA Sciences and the $2.0 million related tax benefit. Net income per diluted share of $0.38 for the first quarter of 2003 represents an increase from the $0.29 in net loss per diluted share in the first quarter of 2002. Net loss per diluted share of $0.29 in the first quarter of 2002 includes a loss of $0.56 related to the impairment of equity investments and the tax benefit associated with this write-down.

 

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Table of Contents

 

Liquidity and Capital Resources

 

As of March 31, 2003, we had $185.9 million of cash and cash equivalents on hand. Our expected primary cash needs on both a short and long-term basis are for capital expenditures, expansion of services, possible acquisitions, geographic expansion, working capital and other general corporate purposes. We have historically funded our operations and growth, including acquisitions, with cash flow from operations, and to a lesser extent in recent years with borrowings and sales of our stock. We are exposed to changes in interest rates on cash equivalents and amounts outstanding under notes payable, notes receivable and lines of credit. Our cash and cash equivalents are invested in financial instruments that are rated A or better by Standard & Poor’s or Moody’s and earn interest at market rates.

 

For the three months ended March 31, 2003, our operating activities provided $5.1 million in cash as compared to $25.3 million for the same period last year. Net income of $21.2 million, depreciation and amortization of $7.2 million, and a $2.4 million decrease in deferred income taxes were partially offset by the net decrease of $25.9 million in working capital. The net decrease in working capital is primarily attributed to an increase in net receivables and a decrease in accrued expenses for payment of 2002 annual bonuses.

 

For the three months ended March 31, 2003, our investing activities used $5.3 million in cash. The net cash paid for capital expenditures of $5.9 million was offset by $0.5 million received from the repayment of notes receivable.

 

For the three months ended March 31, 2003, our financing activities provided $3.5 million in cash, as net proceeds from stock option exercises and purchases under our employee stock purchase plan totaling $4.1 million were offset by $0.5 million in repayments of capital lease obligations and $0.07 million in principal repayments of long-term debt.

 

Working capital as of March 31, 2003 was $215.9 million, compared to $187.7 million at December 31, 2002. The increase in working capital was due primarily to the increase in accounts receivable and unbilled services, net, of $9.8 million, the decrease in unearned income of $5.2 million and the decrease in other accrued expenses of $13.8 million. The number of days revenue outstanding in accounts receivable and unbilled services, net of unearned income, also known as DSO, were 37.9 and 35.4 days for the quarters ended March 31, 2003 and December 31, 2002, respectively. We believe that change in DSO reflects normal fluctuations in the rate of collections of accounts receivable and changes in temporary terms regarding investigator fee down payments. We expect DSO in the future will fluctuate depending on the mix of contracts performed within a quarter and our success in collecting receivables.

 

In June 2002, we amended our revolving credit facility for $50.0 million from Wachovia Bank, N.A., formerly known as First Union National Bank. The purpose of the amendment was to extend the expiration date. Indebtedness under the facility is unsecured and subject to traditional covenants relating to financial ratios. Borrowings under this credit facility are available to provide working capital and for general corporate purposes. As of March 31, 2003, there was no amount outstanding under this credit facility. This credit facility is currently scheduled to expire in June 2003, at which time any outstanding balance will be due.

 

In July 2002, we entered into a new revolving credit facility for $50.0 million with Bank of America, N. A. Indebtedness under the facility is unsecured and subject to traditional covenants relating to financial ratios. Borrowings under this credit facility are available to provide working capital and for general corporate purposes. As of March 31, 2003, there was no amount outstanding under this credit facility. This credit facility is currently scheduled to expire in June 2003, at which time any outstanding balance would be due.

 

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In April 2000, we made an investment in Spotlight Health, Inc., formerly known as ADoctorInYourHouse.com. In January 2001, we entered into an agreement with Spotlight Health and Wachovia Bank, N.A. to guarantee a revolving $2.0 million line of credit provided to Spotlight Health by Wachovia. Indebtedness under the line is unsecured and subject to traditional covenants relating to financial ratios. As of March 31, 2003, Spotlight Health had $2.0 million outstanding under this credit facility. This credit facility is currently scheduled to expire in June 2003, at which time any outstanding balance will be due. We review the financial statements of Spotlight Health on a quarterly basis to determine if they have sufficient financial resources to continue operations. Future events and circumstances may adversely affect Spotlight Health’s financial condition and Spotlight Health might not be in the position to repay the facility. Thus, we can give no assurances that Wachovia will not attempt to collect on our guaranty of this facility.

 

We expect to continue expanding our operations through internal growth and strategic acquisitions. We expect these activities will be funded from existing cash, cash flow from operations and borrowings under our existing or future credit facilities. We believe that these sources of liquidity will be sufficient to fund our operations for the foreseeable future, but offer no assurances. From time to time, we evaluate potential acquisitions and other growth opportunities, which might require additional external financing, and we might seek funds from public or private issuances of equity or debt securities. In particular, our sources of liquidity could be affected by our dependence on a small number of industries and clients, compliance with regulations, international risks, personal injury, environmental or intellectual property claims, as well as other factors described in this document under “Potential Volatility of Quarterly Operating Results and Stock Price” and “Quantitative and Qualitative Disclosures about Market Risk”. In addition, see “Critical Accounting Policies and Estimates” and “Factors that Might Affect our Business or Stock Price” in our Annual Report on Form 10-K for the year ended December 31, 2002.

 

Critical Accounting Policies and Estimates

 

There have been no material changes to our critical accounting policies and estimates since December 31, 2002. For detailed information on our critical accounting policies and estimates, see our Annual Report on Form 10-K for the year ended December 31, 2002.

 

Recently Issued Accounting Standards

 

In June 2001, the Financial Accounting Standards Board (the “FASB”) issued Statement of Financial Accounting Standards No. 143, “Accounting for Asset Retirement Obligations”, or SFAS No. 143, which addresses financial accounting and reporting for obligations associated with the retirement of tangible long-lived assets and the associated asset retirement costs. SFAS 143 requires that the fair value of a liability for an asset retirement obligation be recognized in the period in which it is incurred if a reasonable estimate of fair value can be made. The associated asset retirement costs are capitalized as part of the carrying amount of the long-lived asset. SFAS No. 143 is effective for financial statements issued for fiscal years beginning after June 15, 2002. The adoption of this statement did not have a material impact on our financial statements.

 

In November 2001, the FASB issued Emerging Issues Task Force Rule No. 01-14, or EITF 01-14, Income Statement Characterization of Reimbursements Received for “Out-of-Pocket” Expenses Incurred. EITF 01-14 requires that in cases where the contractor acts as a principal, reimbursements received for out-of-pocket expenses incurred be characterized as revenue and the associated costs included as operating expenses in the income statement. The implementation of this rule resulted only in the gross-up of revenues and expenses and had no impact upon earnings. PPD pays, on behalf of its customers, fees to investigators and test subjects, and other out-of-pocket costs, such as travel, printing, meetings, couriers, etc., for which PPD is reimbursed at cost, without mark-up or profit. PPD will continue to exclude from revenue and expense in the income statement fees and associated reimbursements that we receive as an agent. During the three months ended March 31, 2002 and 2003, fees paid to investigators and other fees that PPD received as an agent and the associated reimbursements were approximately $33.8 million and $44.6 million, respectively.

 

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In November 2002, the EITF finalized its tentative consensus on EITF Issue 00-21, “Revenue Arrangements with Multiple Deliverables”, which provides guidance on the timing and method of revenue recognition for sales arrangements that include the delivery of more than one product or service. EITF 00-21 is effective prospectively for arrangements entered into in fiscal periods beginning after June 15, 2003. The Company is currently evaluating the impact of the adoption of this consensus on the Company’s financial statements.

 

In November 2002, the FASB issued Financial Accounting Standards Board Interpretation No. 45 (“FIN 45”), “Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others, an interpretation of FASB Statement Nos. 5, 57, and 107 and Rescission of FASB Interpretation No. 34.” FIN 45 clarifies the requirements of FASB Statement No. 5, “Accounting for Contingencies,” relating to the guarantor’s accounting for, and disclosure of, the issuance of certain types of guarantees. FIN 45 requires that upon issuance of a guarantee, the guarantor, must recognize a liability for the fair value of the obligation it assumes under that guarantee. The disclosure provisions of FIN 45 are effective for financial statements of interim or annual periods that end after December 15, 2002. FIN 45’s provisions for initial recognition and measurement should be applied on a prospective basis to guarantees issued or modified after December 31, 2002, irrespective of the guarantor’s fiscal year-end. The guarantor’s previous accounting for guarantees that were issued before the date of FIN 45’s initial application may not be revised or restated to reflect the effect of the recognition and measurement provisions of FIN 45. The adoption of this statement did not have a material impact on our financial statements.

 

In December 2002, the FASB issued SFAS No. 148, “Accounting for Stock-Based Compensation – Transition and Disclosure – an Amendment of FASB Statement No. 123.” This Statement amends SFAS No. 123, “Accounting for Stock-Based Compensation”, to provide alternative methods of transition for a voluntary change to the fair value based method of accounting for stock-based employee compensation. In addition, this statement amends the disclosure requirements of SFAS No. 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock-based employee compensation and the effect of the method used on reported results. This statement requires that companies having a year-end after December 15, 2002 follow the prescribed format and provide the additional disclosures in their annual reports. The adoption of this statement did not have a material impact on our financial statements.

 

Taxes

 

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

 

Inflation

 

Our long-term contracts, which are those with a term in excess of one year, generally include an inflation or cost of living adjustment for the portion of the services to be performed beyond one year from the contract date. As a result, we expect that inflation generally will not have a material adverse effect on our operations or our financial condition.

 

 

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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:

 

    our dependence on a small number of industries and clients;

 

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

 

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

 

    our need to recruit and retain experienced personnel;

 

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

 

    intellectual property risks;

 

    the timing of our Discovery Sciences Group milestone payments or other revenue;

 

    the timing of the opening of new offices;

 

    the timing of other internal expansion costs;

 

    the timing and amount of costs associated with integrating acquisitions; and

 

    exchange rate fluctuations between periods.

 

Delays and terminations of trials are often the result of actions taken by our customers 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. 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.

 

Fluctuations in quarterly results or other factors beyond our control could affect the market price of our common stock. Such factors include changes in earnings estimates by analysts, market conditions in our industry, changes in pharmaceutical and biotechnology industries, general economic conditions, and differences in assumptions used as compared to actual results. Any effect on our common stock could be unrelated to our longer-term operating performance.

 

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Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

We are exposed to foreign currency risk by virtue of our international operations. We conduct business in several foreign countries. Approximately 15.1% and 20.3% of our net revenues for the years ended December 31, 2001 and 2002, respectively, were derived from operations outside the United States. Funds generated by each subsidiary are generally reinvested in the country where they are earned. We have not, to date, engaged in derivative or hedging activities related to our potential foreign exchange exposures. Our operations in the United Kingdom generated more than 46.7% of our net revenue from international operations during 2002. Accordingly, we do have some exposure to adverse movements in the pound sterling and other foreign currencies. The United Kingdom has traditionally had a relatively stable currency compared to our functional currency, the U.S. dollar. We anticipate that those conditions will continue for at least the next 12 months, but cannot make any guarantees.

 

The vast majority of our contracts are entered into by our United States or United Kingdom subsidiaries. The contracts entered into by the United States subsidiaries are almost always denominated in United States dollars. Contracts entered into by our United Kingdom subsidiaries are generally denominated in pounds sterling, United States dollars or Euros. Contractual provisions either limit or reduce the economic risk in certain transactions involving multiple currencies.

 

We do have some currency risk resulting from the passage of time between the invoicing of customers under contracts and the ultimate collection of customer 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 and payment from the customer is received will result in our receiving either more or less in local currency than the local currency equivalent of the invoice amount at the time the invoice was prepared and the receivable established. We recognize this difference as a foreign currency transaction gain or loss, as applicable, and report it in other income, net. If exchange rates were to change by 1% in the future, we do not expect this to have a material effect on our financial statements.

 

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 each foreign subsidiary’s financial results are translated to U.S. dollars is as follows:

 

    income statement accounts are translated at average exchange rates for the period;

 

    balance sheet assets and liability accounts are translated at end of period exchange rates; and

 

    equity accounts are translated at historical exchange rates.

 

Translation of the balance sheet in this manner affects the shareholders’ equity account, referred to as the cumulative translation adjustment account. This account exists only in the foreign subsidiary’s U.S. dollar balance sheet and is necessary to keep the foreign balance sheet, stated in U.S. dollars, in balance. Translation adjustments are reported 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, adjustments could in the future be material to our financial statements.

 

Currently there are no material exchange controls on the payment of dividends or otherwise restricting 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, to date, we have not experienced any difficulties in receiving funds remitted from foreign countries. However, if any of these jurisdictions imposed or modified existing exchange control restrictions, the restrictions could have an adverse effect on our financial condition.

 

We are exposed to changes in interest rates on our cash equivalents 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. If interest rates were to change by 1% in the future, we do not expect this to have a material effect on our financial statements.

 

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Item 4. Controls and Procedures

 

(a) Evaluation of disclosure controls and procedures. Our Principal Executive Officer and Principal Financial Officer have reviewed and evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 240.13a-14(c) and 15d-14(c)) as of a date within ninety days before the filing date of this quarterly report. Based on that evaluation, the Principal Executive Officer and Principal Financial Officer have concluded that our current disclosure controls and procedures are effective.

 

(b) Changes in internal controls. There were no significant changes in our internal controls or in other factors that could significantly affect these internal controls subsequent to the date of evaluation.

 

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Part II. OTHER INFORMATION

 

Item 6. Exhibits and Reports on Form 8-K

 

(a)   Exhibits

 

99.1

  

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

99.2

  

Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of The Sarbanes-Oxley Act of 2002 – Chief Financial Officer

 

(b)   Reports on Form 8-K

 

No reports on Form 8-K were filed during the quarter ended March 31, 2003.

 

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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/     LINDA BADDOUR


   

Chief Financial Officer

   

(Principal Financial and Accounting Officer)

Date: May 9, 2003

 

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CERTIFICATION

 

I, Fredric N. Eshelman, certify that:

 

  1.   I have reviewed this quarterly report on Form 10-Q of Pharmaceutical Product Development, Inc.;

 

  2.   Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

  3.   Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

  4.   The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

 

  a.   designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

  b.   evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”); and

 

  c.   presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

 

  5.   The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

 

  a.   all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

 

  b.   any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

 

  6.   The registrant’s other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

 

Date: May 9, 2003

     

By:

 

/s/    FREDRIC N. ESHELMAN


           

Chief Executive Officer

           

(Principal Executive Officer)

 

 

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CERTIFICATION

 

I, Linda Baddour, certify that:

 

  1.   I have reviewed this quarterly report on Form 10-Q of Pharmaceutical Product Development, Inc.;

 

  2.   Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

  3.   Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

  4.   The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

 

  a.   designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

  b.   evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”); and

 

  c.   presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

 

  5.   The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

 

  a.   all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

 

  b.   any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

 

  6.   The registrant’s other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

 

 

 

Date: May 9, 2003

     

By:

 

/s/    LINDA BADDOUR


           

Chief Financial Officer

           

(Principal Financial and Accounting Officer)

 

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