UBS Global Life Sciences Conference. September 26, 2006

Transcription

1 UBS Global Life Sciences Conference September 26, 2006

2 Safe Harbor Statement This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the Act ) that involve a number of risks and uncertainties. These forward-looking statements include statements relating to: the Company s future growth, Pharmaceutical industry growth and increases in clinical trials being conducted, the Company expanding its client base, the Company leveraging its existing relationships, leveraging the strong reputation of PharmaNet, the proposed amendment of the credit facility, 2006 guidance and financial metrics, the Company s ability to increase its client penetration for bioanalytical services, the Company s ability to recruit subjects, the impact of discontinued operations in Miami and Ft. Myers, Canadian tax credits, industry trends, the globalization of clinical trials, cross-selling opportunities, and regulatory changes. Additionally words such as "seek," "intend," "believe," "plan," "estimate," "expect," "anticipate" and other similar expressions are forwardlooking statements within the meaning of the Act. Some or all of the results anticipated by these forward-looking statements may not occur. Factors that could cause or contribute to such differences include, but are not limited to, our ability to leverage the strong reputation of PharmaNet, whether adverse publicity relating to PDGI s Miami operations causes clients to select competitors, not only for early stage branded clinical trials but also for other aspects of PDGI s business; PDGI s ability to resolve open issues relating to its Miami property including whether it can successfully appeal and/or enjoin the Miami-Dade County Unsafe Structures Board ruling and any related fines or expenses if we are unsuccessful, the associated costs and expenses with discontinuing the Company s operations in Miami and Ft. Myers, whether a building permit will be issued, whether PDGI will prevail in the pending land lease litigation; continued adverse publicity related to actions of the United States Senate Finance Committee; developments with respect to the SEC s inquiry and securities class action lawsuits and derivative lawsuits; PDGI s assessment of its current FDA inspections; PDGI s ability to successfully achieve and manage the technical requirements of specialized clinical trial services, while complying with applicable rules and regulations; regulatory changes; changes affecting the clinical research industry; a reduction of outsourcing by pharmaceutical and biotechnology companies; PDGI's ability to compete internationally in attracting clients in order to develop additional business; cancellation of contracts; PDGI s ability to retain and recruit new employees; PDGI's clients' ability to provide the drugs and medical devices used in its clinical trials; PDGI s future stock price; PDGI s financial guidance; and the national and international economic climate as it affects drug development operations. Further information can be found in PDGI's risk factors contained in its Form 10-K filed as the Company s former name, SFBC International, Inc., with the SEC in 2006 and other filings with the Securities and Exchange Commission. We do undertake to update these forward-looking statements, and you are urged to read our filings with the Securities and Exchange Commission.

3 Overview Well Positioned in the Rapidly Growing CRO Industry Diverse Client Base Branded pharmaceutical, biotechnology, generic drug and medical device companies Experienced Management Team Global Operations Strategic locations accommodate complex global programs Strong Clinical Development Expertise in all Therapeutic Areas Focus on attractive, high growth fields From study design to phase I-IV Advanced Technology Platforms PharmaSoft Information Technology State-of-the-art bioanalytical laboratories Financial Strength Cash, cash equivalents and investments in marketable securities of approximately $59.6 million at June 30, 2006

4 Clinical Development of Pharmaceuticals IND submitted NDA submitted Drug discovery Pre-clinical Clinical trials FDA Review Large scale manufacturing/phase lv Phase I healthy volunteers Phase li patients Phase lil patients Phase IV Post marketing & generics COMPOUNDS 250 COMPOUNDS 5 COMPOUNDS 1 FDA Approved Compound PharmaNet Clinical Development, Software and Consulting Services 5 years 1.5 years 6 years 2 years 2 years Synthesis 11.0% Screening Testing 15.5% Toxicology 4.9% Dosage formulation 8.0% Clinical evaluation Phase l lll 32.0% Process Development 9.1% Regulatory Process 4.5% Other 2.0% Clinical evaluation Phase lv 12.9% ~$1 billion to get a new drug to market Pharma R&D Budget Allocation Sources: Pharma.org, Business Insights Interactive: The Pharmaceutical Market Outlook through 2005.

5 Well Positioned in the Rapidly Growing CRO Industry Broader acceptance Outsourcing of drug development services continues to grow $10 Billion market growing 14-16% (1) R&D Results Successes are increasing the number of compounds in the development pipeline Breadth and depth of clinical trials expanding Increasing complexity and globalization of clinical trials driving demand for global CROs with expertise, experience, technical skills and scale Biotechnology benefiting from the R&D expenditure growth combined with further development progress before partnering Increased focus and requirements for post-marketing studies Proven track record of success CROs have demonstrated that they can perform drug development faster and more cost-effectively (1)

6 Diverse Client Base Clinical Mix Client Mix Geographic Mix Early stage Generic Large Pharma Europe ROW USA Late stage Biotech Medium Pharma Canada 2006E Revenue: $281 $290 Million Balanced clinical mix and geographic distribution of clients

7 Experienced Management Team Johane Boucher-Champagne, DSA Ian Holmes, PhD EVP, Early Clinical Development and COO of Anapharm PharmaNet SVP, Corporate Development James P. Burns, Jr., PhD Mary F. Johnson, PhD PharmaNet SVP, Regulatory Consulting Worldwide PharmaNet SVP, Biostatistics Mark Di Ianni Michael E. Laird, RPh EVP, Strategic Initiatives PharmaNet VP, Worldwide Business Development Pablo Fernandez, FFPM Sean P. Larkin PharmaNet SVP, Medical Affairs PharmaNet EVP, Late Phase Development Steven A. George Marc LeBel, PharmD PharmaNet SVP, Information Technology, Worldwide EVP Bioanalytical Laboratories, CEO and President of Anapharm Dalvir Gill, PhD David Natan PharmaNet EVP, US Clinical Research EVP, Reporting and Analysis, Chief Accounting Officer Jack W. Green, PhD Thomas J. Newman, MD PharmaNet SVP, Data Management EVP, Late Stage Development and COO PharmaNet John P. Hamill Robert Reekie, FFPM EVP and CFO PharmaNet EVP, Operations, Europe and Asia-Pacific Gregory M. Hockel, MBA, PhD Robin C. Sheldrick PharmaNet SVP, Regulatory Affairs Worldwide PharmaNet VP, Human Resources

8 Client Service Worldwide: 2,000+ Employees, 30+ Offices, 26 Countries, 5 Continents Clinical Facilities Bioanalytical Laboratories PharmaNet PharmaNet Field-Based Staff Locations Field-Based Staff Amersfoort, NETHERLANDS Bangalore, INDIA Barcelona, SPAIN Blue Bell, PA, USA Boston, MA, USA Buenos Aires, ARGENTINA Charlotte, NC, USA Chicago, IL, USA Frankfurt, GERMANY High Wycombe, UK Kennett Square, PA, USA London, ON, CANADA Madrid, SPAIN Montreal, QC, CANADA Moscow, RUSSIA Mumbai, INDIA Munich, GERMANY Paris, FRANCE Philadelphia, PA, USA Princeton, NJ, USA (2) Quebec City, QC, CANADA Research Triangle Park, NC, USA San Diego, CA, USA Singapore Stockholm, SWEDEN Sydney, AUSTRALIA Toronto, ON, CANADA (2) Trois-Rivieres, QC, CANADA Warsaw, POLAND Washington, DC, USA Wilmington, DE, USA Zurich, SWITZERLAND Belgium Brazil Canada Chile Czech Republic Hong Kong Hungary Indonesia Ireland Israel Italy Japan Korea Mexico Peru Shanghai South Africa Taiwan United States * As of June 2006

9 Strong Clinical Development Expertise: Therapeutic Divisions Medical Expertise (Strategy) Operational Expertise (Implementation) Oncology Neuroscience Cardiovascular Infectious disease Experience and capabilities in high-growth therapeutic areas

10 Industry-leading Research, Technology and Consulting Services Throughout the Clinical Development Process Volunteer recruitment Protocol development Site management and monitoring Phase I IV studies Bioequivalence trials Project management Patient recruitment Clinical laboratory Sample analysis Discovery Method development and validation Biomarkers Stability evaluation Documentation Submission QA/QC Safety/pharmacovigilance Scientific and medical writing Advisory/safety committee participation Data management Biostatistics SAS programming PK/PD modeling Efficacy, toxicity, dosage-optimization, market expansion, and agency-mandated studies Regulatory Statistical Promotional assistance Clinical

11 Services and Expertise: Core Services Phase I Clinical Development Services Facilities in Québec City (168 beds) and Montréal, Canada (150 beds) Bioanalytical Laboratory Services Quantitative determination of drugs and/or metabolites in biological matrices such as blood, serum, plasma, or urine Labs in Princeton, NJ; Philadelphia, PA; Québec City and Toronto, Canada; and Barcelona, Spain Supports preclinical, bioavailability and drug metabolism, bioequivalence, Phase I IV and drug interaction studies

12 Services and Expertise: Core Services Late Clinical Development A complete range of services for drug development and registration Phases II, III, and IV clinical development services Data Management Biostatistics Regulatory Affairs Medical Affairs Safety Reporting Electronic Submissions Web-based technologies Experience in essentially all significant therapeutic areas being pursued by the pharmaceutical industry

13 Services and Expertise: Core Services Post Marketing (Phase IIIb-IV) Dedicated professionals with extensive product-development experience in Phase IIIb IV studies Specialists designing and executing programs that meet the highest standards of scientific integrity and regulatory compliance, while meeting commercial objectives Scientific and medical staff work with client teams to extend patent protection and develop: New indications New formulations Line extensions New dosages New strategies to compete with newly introduced products Rx to OTC switches Reinvigoration of aging brands Enhancing commercial value through scientific expertise

14 Services and Expertise: Consulting Dedicated regulatory professionals with international productdevelopment expertise, including senior-level FDA officials from: Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiologic Health (CDRH) Value added services Clinical development plans and strategies cgmp compliance plans In-licensing evaluations New product due diligence Risk/benefit analysis Best practice assessments Combination product evaluations Assistance with preparation of CMC section Medical and regulatory assessments Evaluation of pre-clinical data for acceptability

15 Services and Expertise: PharmaSoft IT PharmaSoft electronic data capture (EDC) and data management system employed in >50% late stage studies initiated in 2006 Facsimile data capture system with interactive character recognition (ICR) Interactive voice response system (IVRS) Serious adverse event system Project management information system Easy to use, web-based, 21 CFR Part 11 compliant, efficient

16 2006 Strategic Priorities Early Stage Restore early stage business to historical levels of performance Optimize mix of generic and branded business Enhance Phase I capabilities in Montreal Assess opportunities for cost reductions and operational efficiencies Leverage custom assay development expertise New early stage headquarters in Quebec City and associated sale lease-back agreement Timing of Phase I facility in Toronto Closing activities in preparation of sale of Florida facilities

17 2006 Strategic Priorities Late Stage Increase penetration of existing client base and expand client base to drive organic growth Leverage strong development expertise in virtually every therapeutic area with focus on oncology, neurosciences, cardiovascular and infectious diseases Geographic expansion in Asia, Latin America, Central and Eastern Europe Build or buy assessments of complementary services at optimal time Medical Imaging Clinical trial materials management Central laboratory services targeted at niche applications Leverage PharmaSoft IT platform with enhanced marketing investment and/or partnership

18 2006 Strategic Priorities Corporate and Financial Add members to the Board of Directors Amend credit facility Sale lease-back of Quebec City facility

19 How we differentiate PharmaNet Development Group Proven medical, scientific and regulatory expertise in key therapeutic areas around the world Strong project management personnel and tools PharmaSoft Unparalleled client service Dedicated to patient safety

20 Investment Summary Well Positioned in the CRO Industry Diverse Client Base Experienced Management Team Dedicated to patient safety Global Operations Strong Clinical Development Expertise Advanced Technology Platforms Financial Strength Unparalleled client service

21 UBS Global Life Sciences Conference September 26, 2006