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Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts.

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Presentation on theme: "Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts."— Presentation transcript:

1 Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

2 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 2 Safe harbor Information herein contains forward-looking statements pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of All such forward- looking statements are based largely on management’s expectations and are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include competitive factors, outsourcing trends, contract terms, exchange rate fluctuations, the Company’s ability to manage growth and to continue to attract and retain qualified personnel, the Company’s ability to complete acquisitions and to integrate newly acquired businesses and consolidation within the industry and other factors described in the Company’s filings with the Securities and Exchange Commission.

3 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 3 Source: Goldman Sachs, May 20, Global R&D spending 9.3% Overall pharma market 6.6% Global CRO market growth and global R&D spending exceeding overall pharma market growth Global CRO market 13-15% CRO market opportunity accelerating within a decelerating pharma market CRO market

4 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 4 Kendle position Among leading global providers of Phase I-IV clinical development solutions 4,000+ associates in 48 locations in 28 countries across six continents Focus on five regions – North America, Europe, Asia/Pacific, Latin America and Africa Services provided in 90 countries Key therapeutic areas include CNS, Infectious Disease, Oncology, Cardiovascular and Inflammation Named to FORTUNE List of 100 Fastest-Growing Companies for 2008

5 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 5 Our vision “Best-in-class” provider of clinical development services to the biopharmaceutical industry through broad therapeutic and geographic expertise

6 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 6 Our strategy Our vision Operational continuity and leverage via the matrix Customer and business expansion to accelerate growth Infrastructure growth to drive global connectivity

7 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 7 Operational continuity and leverage

8 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 8 Operational excellence High-quality integrated clinical development solutions, from Phase I-IV Capabilities across all therapeutic areas aligned with the fastest-growing areas of development and delivered via a worldwide physician network Global presence to deliver clinical development solutions anywhere in the world, with intimate understanding of local and regional requirements Best-in-class provider Therapeutic expertise Geographic expertise

9 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 9 Source: Jefferies, CRO Survey, March 2007 % of total respondents Vendor relationship management principles Electronic data capture (EDC) Functional outsourcing Preferred provider agreements Centralized sourcing groups Biomarkers research Program outsourcing Offshoring In-sourcing more work Divesting of major facilities groups and/or divisions High throughput processes Dedicated space Strategic relationships Customer drivers for R&D efficiency

10 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 10 Evolving outsourcing relationship structures PROVIDER (Transactional services) Ad-hoc Capacity-based Reactive, project task outsourcing Larger operation, sponsor SOPs Mid-management governance committee Lowest-bid/many providers PARTNER (Alliances) Formalized Virtual/competency-based Planned, portfolio outsourcing Lean operation, coordination SOPs Senior management committee Few partner-providers Source: Tufts Center for the Study of Drug Development, Tufts University

11 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 11 Allocation of development spending by global region – 2007 Expected development spending allocation by 2011; significant increase in Asia/Pacific, Other Source: Jefferies, CRO Survey, March 2007; April 2008 Execution across global footprint Strategic patient access

12 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 12 Continuing globalization Latin America grows from 6% of total revenue in Q to 9% of total revenue in Q % Q % Q Revenue moves away from United States into global markets with a slight shift from 51% in Q to 50% in Q % Q % Q3 2007

13 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 13 Customer and business expansion

14 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 14 Early Stage opportunities Geographic expansion Business expansion

15 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 15 Preclinical/Phase I opportunity Source: Goldman Sachs, Pharmaceutical Services, Dec 2007 and May 2008 Phase I Compounds in Development by Year, Month Preclinical/Phase I a $9.8 billion market by 2012

16 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 16 Early Stage Phase I growth is expected to outpace broader market at approximately 15-16% annually Early Stage will grow to approximately 20% of our business over the next three years UtrechtToronto Morgantown Kendle Clinical Pharmacology Units High-end scientific exploratory medicine focus – FIH to POC Kendle Bioequivalence Unit Generic medicines focus

17 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 17 Asia/Pacific Asia/Pacific growth is estimated at 30-50% through 2013 Kendle’s focus is expanded breadth and depth of key markets to win and deliver megatrials Current Kendle operations Markets targeted for expansion

18 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 18 Infrastructure growth to drive global connectivity

19 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 19 Infrastructure growth to drive global connectivity ComponentExampleOutcome Finance, Commercial Operations Functional Business orientation and sophistication Operational Asia Pacific, Early Stage Scientific and technical leadership Executive C-suite movement Leadership leverage System/ProcessesInfrastructure/ERP Global connectivity and leverage

20 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 20 Financial profile

21 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 21 Q financial highlights

22 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 22 Growth in revenues

23 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 23 Operating margin comparison

24 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 24 Strong growth in EPS

25 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 25 Solid growth in net sales

26 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 26 Strong growth in backlog

27 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a revised guidance

28 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 28

29 N o r t h A m e r i c a E u r o p e A s i a / P a c i f i c L a t i n A m e r i c a A f r i c a 29 Phase I-IV clinical development focus Early StageClinical Development Regulatory Affairs and Quality BiometricsLate Phase Early StageLate Stage First-in-human to proof-of-concept Bioequivalence & pharmacokinetics studies Phase II–III Resourcing (EU) Strategic Clinical Development Planning Regulatory Consulting & Submissions Clinical Trial Regulatory Affairs Nonclinical Consulting CMC Development Pharmacovigilance and Safety Clinical Data Management Biostatistics Adaptive Clinical Trials eClinical (EDC) services Phase IIIB/IV Health Economics, Patient-Reported Outcomes and Outcomes Research Product/Disease Registries and Observational Studies Scientific Events and Medical Education Medical Affairs


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