dec.11, 2008 raymond james boston fall investors conference boston, massachusetts

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

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

Dec.11, 2008

Raymond James Boston Fall Investors ConferenceBoston, Massachusetts

Page 2: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a2

Safe harbor

Information herein contains forward-looking statements pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. 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.

Page 3: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a3

Source: Goldman Sachs, May 20, 2008.

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

Page 4: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a4

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

Page 5: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a5

Our vision

“Best-in-class” provider of clinical

development services to the biopharmaceutical

industry through broad therapeutic

and geographic expertise

Page 6: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a6

Our strategy

Our vision

Operational continuity and leverage via

the matrix

Customer and business expansion to accelerate

growth

Infrastructure growth to

drive global connectivity

Page 7: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a7

Operational continuity and leverage

Page 8: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a8

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

Page 9: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a9

Source: Jefferies, CRO Survey, March 2007

% of total respondents

0 10 20 30 40 50 60 70 80 90

Dedicated space

High throughput processes

Divesting of major facilities groups and/ordivisions

In-sourcing more work

Offshoring

P rogram outsourcing

Biomarkers research

Centralized sourcing groups

P referred provider agreements

Functional outsourcing

Electronic Data Capture (EDC)

Vendor relationship management principlesVendor 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 relationshipsCustomer drivers for R&D efficiency

Page 10: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a10

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

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

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 a11

11

Allocation of development spendingby global region – 2007

Expected development spendingallocation by 2011; significant increase

in Asia/Pacific, Other

Source: Jefferies, CRO Survey, March 2007; April 2008

Execution across global footprintStrategic patient access

Page 12: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a12

Continuing globalization

Latin America grows from 6% of

total revenue in Q3 2007 to 9% of

total revenue in Q3 2008

9%

Q3 2008

6%

Q3 2007

Revenue moves away from United

States into global markets with a

slight shift from 51% in Q3 2007 to

50% in Q3 2008

50%

Q3 2008

51%

Q3 2007

Page 13: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a13

Customer and business expansion

Page 14: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a14

Early Stage opportunities

Geographic expansion

Business expansion

Page 15: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a15

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

Page 16: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a16

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 UnitGeneric medicines focus

Page 17: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a17

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

Page 18: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a18

Infrastructure growth to drive global connectivity

Page 19: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a19

Infrastructure growth to drive global connectivity

Component Example Outcome

Finance, Commercial Operations

Functional Business orientation and sophistication

OperationalAsia Pacific, Early Stage

Scientific and technical leadership

Executive C-suite movement Leadership leverage

System/Processes Infrastructure/ERPGlobal connectivity and leverage

Page 20: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a20

Financial profile

Page 21: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a21

Q3 2008 financial highlights

Page 22: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a22

Growth in revenues

Page 23: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a23

Operating margin comparison

Page 24: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a24

Strong growth in EPS

Page 25: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a25

Solid growth in net sales

Page 26: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a26

Strong growth in backlog

Page 27: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a27

2008 revised guidance

Page 28: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a28

Page 29: Dec.11, 2008 Raymond James Boston Fall Investors Conference Boston, Massachusetts

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 a29

Phase I-IV clinical development focus

Early Stage Clinical Development

Regulatory Affairs and Quality

Biometrics Late Phase

Early Stage Late 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