Pharmaceutical Product Development NASDAQ: PPDI. Dan Darazsdi Chief Financial Officer. Credit Suisse Healthcare Conference November 2009

Transcription

1 Pharmaceutical Product Development NASDAQ: PPDI Dan Darazsdi Chief Financial Officer Credit Suisse Healthcare Conference November 2009

2 Safe Harbor Except for historical information, all of the statements, expectations and assumptions discussed in today s presentation, including statements and expectations regarding PPD s future financial performance, the market for CRO services and its compound partnering initiatives, are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forwardlooking statements, it is possible that future circumstances may differ from the assumptions on which such statements are based. Additional factors that could cause actual results to differ materially are set forth from time to time in the SEC filings of PPD. To ensure compliance with Reg. FD, PPD will not disclose during this presentation or Q&A session any material information that has not been previously publicly disclosed. Regulation G Reconciliation This presentation includes selected non-gaap financial measures. For a presentation of and reconciliation to the most directly comparable GAAP financial measures, go to the link titled GAAP/Non-GAAP Reconciliation Presentation under Presentations & Events in the Investors section of PPD s Web site located at

3 Company Profile Provides discovery, research and development (R&D) and post-approval services to pharmaceutical, biotechnology and medical device companies as well as academic and government organizations Founded in 1985; IPO January, 1996 (NASDAQ) Offices in 38 countries and more than 10,000 professionals worldwide Headquarters in Wilmington, NC

4 Service Offerings Accelerate Development With Integrated Services & Global Reach Capitalize On Our Strengths Service, People & Quality Discover New Solutions & Strategies With Expertise & Experience

5 Global Infrastructure PPD locations Field staff Partners (country coverage)

6 Recent Investments FTE Locations Capabilities InnoPharm Acquisition ~300 Russia Phase II-IV Ukraine Data Management Biostatistics AbC.R.O. Acquisition ~230 Romania Phase II-IV Bulgaria Serbia Croatia Merck Vaccine Lab Acquisition ~80 United States Vaccine Testing Singapore GCL ~10 Singapore Global Central Lab Services Ireland cgmp Lab - Ireland cgmp Analytical Testing (Under Development) Excel PharmaStudies Acquisition ~300 China Phase II-IV Data Management Biostatistics Regulatory

7 China Market Opportunity Attractive recruiting environment for clinical trials Vast patient populations Large, centralized hospitals Improving regulatory and IP environment Significant cost efficiencies Rapidly growing pharmaceutical market CAGR: 21% forecast CAGR: 19.5% Accounts for 17.5% of the Asia Pacific pharmaceutical market # of Trials Open Trials with Sites in China* 3Q Q Q 2009 *Includes recruiting and not yet recruiting trials funded by industry, government, NGOs and other sources Clinical Trials by Therapeutic Area Other (20%) Metabolic (6%) Infectious Diseases (9%) Oncology (41%) CNS (10%) Cardiovascular (14%) Source: Datamonitor Industry Profiles, December 2008;

8 Acquisition of Excel PharmaStudies, Inc. One of the largest contract research organizations in China, providing Phase II-IV clinical, data management, biostatistics and regulatory affairs More than 300 employees, principally in over 15 cities throughout China Broad therapeutic expertise, with vaccine research center in China Extensive client base, including multinational and national biopharmaceutical companies Combining Excel s drug development expertise with PPD s global central laboratory operations in Beijing and Singapore positions PPD to deliver a broad set of services in Asia Pacific Provides PPD additional capacity and expertise in China, and creates solid foundation for future growth in Asia Pacific

9 PPD Asia Pacific ~750 professionals in region ~300 professionals in China Beijing China Seoul Korea Tokyo Japan Presence in 12 countries Full service drug development Bangalore India New Delhi India Mumbai India Bangkok Thailand Hong Kong Taipei Taiwan Manila Philippines Ho Chi Minh City Vietnam Singapore Jakarta Indonesia Darwin PPD Locations Field Staff Perth Australia Sydney Melbourne Auckland New Zealand

10 Compound Partnering Business Spin-off Separates compound partnering business from core CRO business Eliminates earnings dilution from compound partnering business Enables compound partnering business to access external capital without any constraints associated with operating in combination with the CRO business Spin-off is expected through a tax-free, pro rata dividend distribution of stock of the compound partnering company to PPD shareholders Creates two well-capitalized, focused, independent public companies PPD will continue to operate under the PPD name focused solely on its drug discovery and development service businesses, and will remain listed on the NASDAQ Stock Market under current ticker symbol PPDI New compound partnering company will include approximately $100 million in cash, PPD s dermatology business unit and all PPD rights to Priligy, alogliptin, alogliptin/actos, statin compound for treatment of dyslipidemia and all future compound partnering programs Expect spin-off to unlock the intrinsic value of both businesses Expect to complete spin-off in the middle of 2010

11 Development Services Strategy Continue to build core competencies in key markets globally Strategic geographic expansion and growth Clinical (Greenfield, M&A) Labs (New vaccine testing lab, GCL Singapore, GMP Ireland) Reinvigorate growth in North America and Latin America markets Pursue additional strategic outsourcing arrangements (Merck) Continue to win large preferred provider opportunities Increase penetration at top R&D spenders Expand post-approval and non-traditional services Continue to maximize value for our stakeholders BEST PEOPLE, QUALITY & VALUE FOR CLIENTS

12 Sponsor/CRO Relationship Continuum As relationships move from transactional to strategic, value increases for the sponsor and the CRO Strategic Partnering Value Created for CRO Transactional Outsourcing Sponsor and CRO work together on individual trials/service areas Preferred Provider Sponsor and CRO establish core teams and build collaborative mechanisms CRO has high level of familiarity with sponsor pipeline, culture, and processes Sponsor and CRO share common goals and objectives Sponsor and CRO engage in joint strategic planning CRO makes directed investments that will drive R&D productivity for the sponsor CRO acts on directions from sponsor Value Created for Sponsor

13 Merck Case Study Partnership Model: Lab Acquisition and Long Term Service Agreement PPD acquired Merck s previously under-utilized vaccine testing lab lab Merck committed to to a five year service agreement for for vaccine testing and central lab lab services Deal improved lab lab efficiency through migration from cost center to to profit center Lab Acquisition Acquired 130,000 ft 2 state-ofthe-art vaccine testing lab Employed 80 highly trained scientists Enables PPD to offer new vaccine services to other biopharma clients Integration Developed IT systems to allow for seamless flow of data between vaccine lab and PPD global central labs Smooth transition without service disruption End-to-End Lab Solution Five year lab services commitment from Merck PPD to provide majority of traditional central lab services, as well as assay development and testing services to support vaccine portfolio

14 What Differentiates PPD Heritage of excellence Effectively manage complex, multinational trials globally Leverage advanced technologies to speed drug development Broad therapeutic knowledge and experience Core strength: Our people Flexibility and responsiveness tailored to our customers Financial stability COMMITMENT TO OPERATIONAL EXCELLENCE

15 OVERALL COMPANY PERFORMANCE

16 Historical Performance Backlog (Millions) CAGR 26% $2,238 $2,655 $3,221$3,155 $1,799 $498 $674 $974 $1,120 $1, Mo. Ended 9/30/09

17 Historical Performance Net Revenue* (Millions) CAGR 20% $1,146 $1,295 $1,453 $962 $989 $345 $432 $563 $669 $ Mo. Ended 9/30/09 *Net revenue amounts exclude reimbursed out-of-pockets to 2008 amounts have not been restated to exclude discontinued operations relating to the sale of Piedmont Research Center, LLC.

18 Historical Performance Diluted Earnings Per Share* (Split-adjusted) CAGR 25% $1.32 $1.36 $1.70 $1.03 $1.02 $0.77 $0.81 $0.29 $0.43 $ Mo. Ended 9/30/09 *See GAAP/Non-GAAP reconciliation at to 2008 amounts have not been restated to exclude discontinued operations relating to the sale of Piedmont Research Center, LLC.

19 Historical Performance Cash Flow from Operations and Free Cash Flow Cash Flow from Operations (Millions) $380.5 Free Cash Flow (Millions) $313.6 $226.6 $187.5 $137.1 $131.8 $99.4 $ Mo. Ended 9/30/ Mo. Ended 9/30/09

20 Investment Opportunity Innovative, global company Robust backlog Industry-leading margins Strong cash position No long-term debt Only CRO paying a dividend Clear long-term strategy to drive shareholder value

21 Pharmaceutical Product Development NASDAQ: PPDI Dan Darazsdi Chief Financial Officer Credit Suisse Healthcare Conference November 2009