ubs global life sciences conference september 26,...
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UBS Global Life Sciences Conference________________________
September 26, 2006
Safe Harbor StatementThis 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 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, andregulatory changes.
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,
Additionally words such as "seek," "intend," "believe," "plan," "estimate," "expect," "anticipate" and other similar expressions are forward-looking 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.
Overview
Well Positioned in the Rapidly Growing CRO IndustryDiverse Client Base
Branded pharmaceutical, biotechnology, generic drug and medical device companies
Experienced Management TeamGlobal Operations
Strategic locations accommodate complex global programs
Strong Clinical Development Expertise in all Therapeutic AreasFocus on attractive, high growth fields From study design to phase I-IV
Advanced Technology PlatformsPharmaSoft® Information Technology State-of-the-art bioanalytical laboratories
Financial StrengthCash, cash equivalents and investments in marketable securities of approximately $59.6 million at June 30, 2006
Clinical Development of PharmaceuticalsIND submitted
5 years
1.5 years
6 years
2 years
2 years
10000COMPOUNDS
250COMPOUNDS 5 COMPOUNDS
Phase I 20-100 healthy
volunteers
Phase lI 100-500 patients
Phase lIl 1000-5000
patients
FDA ReviewLarge scale
manufacturing/Phase lVClinical trials
NDA submitted
Drug discovery Pre-clinical
Synthesis11.0%
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%
Pharma R&D Budget Allocation
~$1 billion to get a new drug to market
Clinical evaluation Phase lV
12.9%
Phase IV Post marketing &
generics
1 FDA Approved
Compound
PharmaNet Clinical Development, Software and Consulting Services
Sources: Pharma.org, Business Insights Interactive: The Pharmaceutical Market Outlook through 2005.
Well Positioned in the Rapidly Growing CRO Industry
Broader acceptanceOutsourcing of drug development services continues to grow$10 Billion market growing 14-16%(1)
R&D ResultsSuccesses are increasing the number of compounds in the development pipeline
Breadth and depth of clinical trials expandingIncreasing 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 partneringIncreased focus and requirements for post-marketing studiesProven track record of success
CROs have demonstrated that they can perform drug development faster and more cost-effectively
(1) www.ACRO.org
Diverse Client Base
Late stage
Early stage
Medium Pharma
Biotech
Large Pharma
Clinical Mix Client Mix Geographic Mix
ROW
Canada
USA
EuropeGeneric
2006E Revenue: $281 – $290 MillionBalanced clinical mix and geographic distribution of clients
Experienced Management TeamJohane Boucher-Champagne, DSAEVP, Early Clinical Development and COO of Anapharm
Ian Holmes, PhDPharmaNet SVP, Corporate Development
Mark Di IanniEVP, Strategic Initiatives
Michael E. Laird, RPhPharmaNet VP, Worldwide Business Development
James P. Burns, Jr., PhD PharmaNet SVP, Regulatory Consulting Worldwide
Mary F. Johnson, PhDPharmaNet SVP, Biostatistics
Pablo Fernandez, FFPMPharmaNet SVP, Medical Affairs
Sean P. LarkinPharmaNet EVP, Late Phase Development
Gregory M. Hockel, MBA, PhD PharmaNet SVP, Regulatory Affairs Worldwide
Robin C. SheldrickPharmaNet VP, Human Resources
Steven A. George PharmaNet SVP, Information Technology, Worldwide
Marc LeBel, PharmDEVP Bioanalytical Laboratories, CEO and President of Anapharm
Dalvir Gill, PhD PharmaNet EVP, US Clinical Research
David NatanEVP, Reporting and Analysis, Chief Accounting Officer
John P. HamillEVP and CFO
Robert Reekie, FFPMPharmaNet EVP, Operations, Europe and Asia-Pacific
Jack W. Green, PhD PharmaNet SVP, Data Management
Thomas J. Newman, MDEVP, Late Stage Development and COO PharmaNet
Client Service Worldwide: 2,000+ Employees, 30+ Offices, 26 Countries, 5 Continents
Amersfoort, NETHERLANDSBangalore, INDIABarcelona, SPAINBlue Bell, PA, USABoston, MA, USABuenos Aires, ARGENTINACharlotte, NC, USAChicago, IL, USA
Munich, GERMANYParis, FRANCEPhiladelphia, PA, USAPrinceton, NJ, USA (2)Quebec City, QC, CANADAResearch Triangle Park, NC, USASan Diego, CA, USASingapore
Frankfurt, GERMANY High Wycombe, UKKennett Square, PA, USALondon, ON, CANADAMadrid, SPAINMontreal, QC, CANADAMoscow, RUSSIAMumbai, INDIA
BelgiumBrazilCanadaChileCzech RepublicHong Kong
Hungary IndonesiaIrelandIsraelItalyJapan
Field-Based Staff
Clinical Facilities
Bioanalytical Laboratories
PharmaNet
PharmaNet Field-Based Staff
Stockholm, SWEDENSydney, AUSTRALIAToronto, ON, CANADA (2)Trois-Rivieres, QC, CANADAWarsaw, POLANDWashington, DC, USAWilmington, DE, USAZurich, SWITZERLAND
KoreaMexicoPeruShanghaiSouth AfricaTaiwanUnited States
Locations
* As of June 2006
Strong Clinical Development Expertise: Therapeutic Divisions
Oncology
Neuroscience
Cardiovascular
Infectious diseaseOperational Expertise
(Implementation)
Medical Expertise
(Strategy)
Experience and capabilities in high-growth therapeutic areas
Industry-leading Research, Technology and Consulting Services Throughout the Clinical Development Process
Volunteer recruitment
Bioequivalence trials
Protocol development
Project management
Site management and monitoring
Patient recruitment
Phase I–IV studies
Clinical laboratory
Sample analysis
Stability evaluation
Discovery Method development and validation
Documentation
Submission
QA/QC
Safety/pharmacovigilance
Scientific and medical writing
Data management Biostatistics SAS® programming
Efficacy, toxicity, dosage-optimization, market expansion, and agency-mandated studies
Regulatory Statistical Promotional assistance Clinical
Biomarkers
Advisory/safety committee participation
PK/PD modeling
Services and Expertise: Core Services
Phase I Clinical Development ServicesFacilities in Québec City (168 beds) and Montréal, Canada (150 beds)
Bioanalytical Laboratory ServicesQuantitative determination of drugs and/or metabolites in biological matrices such as blood, serum, plasma, or urineLabs 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
Services and Expertise: Core Services
Late Clinical DevelopmentA complete range of services for drug development and registration
Phases II, III, and IV clinical development servicesData ManagementBiostatisticsRegulatory Affairs Medical AffairsSafety ReportingElectronic SubmissionsWeb-based technologies
Experience in essentially all significant therapeutic areas being pursued by the pharmaceutical industry
Services and Expertise: Core Services
Post Marketing (Phase IIIb-IV) Dedicated professionals with extensive product-development experience in Phase IIIb–IV studiesSpecialists designing and executing programs that meet the highest standards of scientific integrity and regulatory compliance, while meeting commercial objectivesScientific and medical staff work with client teams to extend patent protection and develop:
New indicationsNew formulationsLine extensionsNew dosagesNew strategies to compete with newly introduced productsRx to OTC switchesReinvigoration of aging brands
Enhancing commercial value through scientific expertise
Services and Expertise: Consulting
Dedicated regulatory professionals with international product-development 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 strategiescGMP compliance plansIn-licensing evaluationsNew product due diligenceRisk/benefit analysisBest practice assessments
Combination product evaluationsAssistance with preparation of CMC section Medical and regulatory assessments Evaluation of pre-clinical data for acceptability
Services and Expertise: PharmaSoft® IT
PharmaSoft® electronic data capture (EDC) and data management system employed in >50% late stage studies initiated in 2006Facsimile data capture system with interactive character recognition (ICR)Interactive voice response system (IVRS)Serious adverse event systemProject management information system
Easy to use, web-based, 21 CFR Part 11 compliant, efficient
2006 Strategic Priorities – Early Stage
Restore early stage business to historical levels of performanceOptimize 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
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
2006 Strategic Priorities – Corporate and Financial
Add members to the Board of Directors
Amend credit facility
Sale lease-back of Quebec City facility
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
Investment Summary
Diverse Client Base
Global Operations Well Positioned in the CRO Industry
Experienced Management Team
Advanced Technology Platforms
Strong Clinical Development Expertise
Financial StrengthDedicated to patient safety Unparalleled client service
UBS Global Life Sciences Conference________________________
September 26, 2006