-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, K5JuzfrBAMY9yZS8LXlwq01y+byRxbgaZziptC9+H3/rD+sgsuVurbeB0s1Swju+ pTv7iTtqoCvO5sHlnIsGQg== 0001193125-08-086896.txt : 20080422 0001193125-08-086896.hdr.sgml : 20080422 20080422165506 ACCESSION NUMBER: 0001193125-08-086896 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080422 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080422 DATE AS OF CHANGE: 20080422 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PHARMACEUTICAL PRODUCT DEVELOPMENT INC CENTRAL INDEX KEY: 0001003124 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 561640186 STATE OF INCORPORATION: NC FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-27570 FILM NUMBER: 08769693 BUSINESS ADDRESS: STREET 1: 929 NORTH FRONT STREET CITY: WILMINGTON STATE: NC ZIP: 28401 BUSINESS PHONE: 9102510081 MAIL ADDRESS: STREET 1: 929 NORTH FRONT STREET CITY: WILMINGTON STATE: NC ZIP: 28401 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 22, 2008

 

 

PHARMACEUTICAL PRODUCT DEVELOPMENT, INC.

(Exact name of Registrant as specified in its charter)

 

 

North Carolina

(State or other jurisdiction of incorporation)

 

0-27570   56-1640186
(Commission file Number)   (IRS Employer ID Number)

929 North Front Street, Wilmington, North Carolina 28401

(Address of principal executive offices) (Zip Code)

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

NA

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act

 

¨ Pre-commencement communications material pursuant to Rule 14d-2(b) under the Exchange Act

 

¨ Pre-commencement communications material pursuant to Rule 13e-4(c) under the Exchange Act

 

 

 


Item 2.02 Results of Operations and Financial Condition.

On April 22, 2008, the Company issued a press release announcing its financial and operating results for the three months ended March 31, 2008. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein in its entirety by reference.

The information furnished in this Item, including the exhibit, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.

  

Description

99.1

   Press release dated April 22, 2008 of Pharmaceutical Product Development, Inc. announcing its financial and operating results for the three months ended March 31, 2008. (Furnished pursuant to Item 2.02, not filed; see Item 2.02 above.)


SIGNATURES

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

 

  Pharmaceutical Product Development, Inc.
Date: April 22, 2008   By:  

/s/ Daniel Darazsdi

  Name:   Daniel Darazsdi
  Title:   Chief Financial Officer
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

Contacts:
Dan Darazsdi

+910 558 7915

dan.darazsdi@wilm.ppdi.com

Craig Eastwood

+910 558 7585

craig.eastwood@wilm.ppdi.com

FOR IMMEDIATE RELEASE

PPD REPORTS FIRST QUARTER 2008 FINANCIAL RESULTS

Highlights:

 

 

$690 million in new authorizations

 

 

Book-to-bill ratio of 1.51

 

 

Development segment net revenue growth of 15.9 percent over Q1 2007

 

 

Record cash flow from operations of $117 million

WILMINGTON, NC, April 22, 2008 - PPD, Inc. (Nasdaq: PPDI) today reported its financial and operating results for the first quarter ended March 31, 2008.

PPD recorded net revenue of $396.2 million for the first quarter of 2008, an increase of 19.3 percent over net revenue of $332.3 million for the first quarter of 2007. First quarter 2008 net revenue included a $15.0 million milestone payment triggered by the FDA’s acceptance of Takeda Pharmaceutical Company Limited’s new drug application (NDA) for alogliptin, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes.

Income from operations for first quarter 2008 was $67.9 million, compared to income from operations of $60.0 million for the same period in 2007. Research and development expense for the first quarter 2008 was $4.3 million, compared to $1.9 million for the same period last year. This increase in R&D expense was related primarily to the costs incurred in conducting trials for PPD’s statin compound for the treatment of dyslipidemia. In March 2008, Accentia Biopharmaceuticals, Inc. announced the results of its SinuNase Phase III clinical trial and reported that SinuNase failed to meet its goal in treating chronic sinusitis patients. As a result, PPD’s income from operations for the first quarter 2008 included a charge to write-off the $1.6 million of remaining unamortized value of its royalty interest in SinuNase.

First quarter 2008 GAAP earnings per diluted share were $0.33, compared to earnings per diluted share of $0.35 for the same period last year. First quarter 2008 GAAP earnings per diluted share included charges of $12.5 million, net of tax. These charges, net of tax, consisted of a $1.1 million write-off of the royalty interest in SinuNase noted above, a $6.5 million impairment of our equity investment in Accentia and a $4.9 million impairment of an investment in PPD’s short-term investment portfolio. Excluding these charges, non-GAAP earnings per diluted share for the first quarter 2008 were $0.44.

Segment performance

Development segment net revenue for the first quarter of 2008 was $347.8 million, an increase of 15.9 percent over the same period in 2007. Development segment income from operations for the first quarter of 2008 was $58.3 million, compared to $61.6 million for the same period in 2007.

 


Discovery sciences segment net revenue for the first quarter of 2008 was $19.7 million, compared to $4.5 million in the same period last year. Net revenue for this segment included the $15.0 million milestone payment from Takeda, which was partially offset by the increase in R&D expense noted above. Discovery sciences segment first quarter 2008 income from operations was $9.6 million, compared to a loss from operations of $1.5 million for the first quarter of 2007.

Other Financial Information

New business authorizations for the first quarter of 2008 totaled $690.0 million, a new record and a 27.7 percent year-over-year increase. The cancellation rate for the first quarter of 2008 was 19.6 percent, resulting in a book-to-bill ratio of 1.51. Backlog at March 31, 2008 was $2.84 billion. Year-to-date (YTD) days sales outstanding (DSO) at March 31, 2008 were 46.0 days, compared to YTD DSO at December 31, 2007 of 50.8 days. First quarter 2008 cash flow from operations was $117 million. At March 31, 2008, PPD had $602 million in cash, cash equivalents and short-term investments, and no long-term debt. The effective tax rate for the first quarter 2008 was 30.0%, which was positively impacted by a tax benefit realized from the disposal of certain assets.

“Building on the momentum from late 2007, we posted record bookings and a strong book-to-bill ratio, and ended the quarter with a solid backlog of $2.84 billion,” said Fred Eshelman, chief executive officer of PPD. “We generated outstanding cash flow from our business operations and are making real progress on improving DSO.” Commenting on compound partnering, Eshelman stated, “Although we were disappointed with the results of the SinuNase Phase III trial, we are pleased with the FDA’s acceptance of the NDA for alogliptin and the overall progress of our compound partnering portfolio.”

The company is disclosing non-GAAP earnings per diluted share for the first quarter of 2008 because the charges for the write-off of the SinuNase royalty interest, the impairment of the equity investment in Accentia and the impairment of the short-term investment are not directly related to the revenue and expense associated with the core development services we provide to our clients. While this non-GAAP financial measure is not superior to or a substitute for the comparable GAAP measure of earnings per diluted share, we believe this information is useful to investors for period-to-period comparisons and because it provides additional information on the performance of PPD’s core service businesses. The company’s management also uses this information to measure operating performance and to compare that performance with results from prior periods and the performance of PPD’s competitors.

PPD will conduct a live conference call and audio webcast tomorrow, April 23, 2008, at 9:00 a.m. EST to discuss its first quarter 2008 results. A Q&A session will follow. To access the webcast, please visit http://www.ppdi.com and follow the directions under the Investor Presentations & Events link in the Corporate section of the PPD Web site. A replay of the webcast will be available shortly after the call. The conference call will be broadcast live over the Internet, and the live call may be accessed via the following direct dial number:

 

 

Participant toll free dial in: +877 644 0692

 
 

Conference ID: 39991203

 

PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 31 countries and more than 10,400 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients. For more information, visit our Web site at http://www.ppdi.com.

 

   2   


Except for historical information, all of the statements, expectations and assumptions contained in this news release, including expectations and assumptions about the company’s backlog, future growth and compound partnering business, are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause actual results to differ materially include the following: continued success in sales growth; loss of large contracts; increased cancellation rates; risks associated with acquisitions and investments, such as impairments; failure or refusal of the FDA to approve the NDA for alogliptin; risks associated with the development and commercialization of drugs, including R&D expense, earnings dilution and obtaining regulatory approvals; risks associated with and dependence on collaborative relationships; currency fluctuations; the ability to attract and retain key personnel; rapid technological advances that make our products and services less competitive; economic conditions and outsourcing trends in the pharmaceutical, biotechnology and medical device industries and academic and government-sponsored research sectors; competition within the outsourcing industry; and the other risk factors set forth from time to time in the SEC filings for PPD, copies of which are available free of charge upon request from the PPD investor relations department.

 

   3   


PPD, Inc.

Statement of Operations Data

(in thousands, except per share amounts)

(unaudited)

 

     GAAP    Non-GAAP
     Three Months Ended
March 31,
   Adjustments     Three Months
Ended
March 31, 2008,
as adjusted
     2008     2007    2008    

Net revenue:

         

Development

   $ 347,798     $ 300,156    $ —       $ 347,798

Discovery Sciences

     19,767       4,383      —         19,767

Reimbursed out-of-pockets

     28,681       27,713      —         28,681
                             

Total net revenue

     396,246       332,252      —         396,246

Direct costs:

         

Development

     177,190       151,915      —         177,190

Discovery Sciences

     2,708       2,358      —         2,708

Reimbursable out-of-pocket expenses

     28,681       27,713      —         28,681
                             

Total direct costs

     208,579       181,986      —         208,579

Research and development

     4,330       1,905      —         4,330

Selling, general and administrative

     98,930       75,738      —         98,930

Depreciation and amortization

     14,871       12,586      —         14,871

Impairment of intangible asset

     1,607       —        (1,607 )     —  
                             

Income from operations

     67,929       60,037      1,607       69,536

Impairment of investments

     (16,319 )     —        16,319       —  

Other income, net

     5,717       4,559      —         5,717
                             

Income before income taxes

     57,327       64,596      17,926       75,253

Income tax expense

     17,198       22,609      5,378       22,576
                             

Net income

   $ 40,129     $ 41,987    $ 12,548     $ 52,677
                             

Net income per share:

         

Basic

   $ 0.34     $ 0.36      $ 0.44
                       

Diluted

   $ 0.33     $ 0.35      $ 0.44
                       

Dividends declared per common share

   $ 0.10     $ 0.03     
                   

Weighted average number of shares outstanding:

         

Basic

     119,386       117,875        119,386
                       

Diluted

     120,996       119,329        120,996
                       


PPD, Inc.

Balance Sheet Data

(in thousands)

(unaudited)

 

     March 31,
2008
   December 31,
2007

Cash, cash equivalents and short-term investments

   $ 601,889    $ 502,384

Accounts receivable and unbilled services, net

     446,820      481,477

Working capital

     665,649      599,980

Total assets

     1,751,356      1,684,375

Unearned income

     217,174      205,779

Shareholders’ equity

     1,209,458      1,150,096

Additional information

(in thousands)

(unaudited)

 

Cash, cash equivalents and short-term investments categories

Cash and cash equivalents

   $ 372,977    $ 171,427

Auction Rate Securities

     176,350      209,475

Other municipal debt securities

     34,011      111,230

Other securities

     18,551      10,252
             
   $ 601,889    $ 502,384
             
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