Kendle International 8K Regulation FD Disclosure | KNDL 30 Jan 08

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

Real

people.

Real

results.

Kendle

At the Forefront of New Opportunity

Wachovia 2008 Healthcare Conference

January 30, 2008

Exhibit 99.1

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

Real

people.

Real

results.

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.

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

Real

people.

Real

results.

Phase I-IV Clinical Development Focus

Global Clinical

Development

Global Clinical

Development

Global

Regulatory Affairs

Global

Biometrics

Global Late

Phase

Early Stage

Late Stage

•

Phase I -

Bioequivalence

•

Phase I –

Clinical

Pharmacology

•

Phase II–III

•

Resourcing

(EU)

•

Regulatory

Consulting &

Submissions

•

Clinical Quality

Assurance

•

Pharmacovigilance

and Safety

•

Medical Writing

•

Clinical Trial

Regulatory

•

Document

Management

•

Investigator Contracts

•

Data

Management

•

Biostatistics

•

Scientific

Programming

•

Phase IIIB/IV

•

Registries:

Pregnancy,

Product and

Disease

•

Health

Economics and

Outcomes

Research

•

Pharmaco-

epidemiology

•

Scientific

Events and

Medical

Education

Medical Affairs

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

Real

people.

Real

results.

Key Market Opportunities

Early Stage Opportunity

Mega Trials Growth

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

Real

people.

Real

results.

Early Stage Opportunity

•

Preclinical/Phase I growth

•

Generics

–

Bioequivalence

–

Biosimilars

•

New experienced leadership

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

Real

people.

Real

results.

Preclinical/Phase I Opportunity

Phase I Compounds in Development by Year, Month

Source: Goldman Sachs, Pharmaceutical Services Dec 2007

•

Preclinical/Phase I a $8.1 billion

market by 2011

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

Real

people.

Real

results.

Source: Merrill Lynch, Generic Perspectives 2008, Jan. 2, 2008

Generic industry

An increasing opportunity for Phase I bioequivalence

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

Real

people.

Real

results.

•

Growth expected as larger number of compounds come off patent

•

Global generics market estimated at $77 billion (2006), or 12% of $643 billion

total pharma market

•

EU governments actively encouraging the use of generics

•

Generics growth has increased more than 20% annually for past five years

•

By contrast, sales of branded drugs is rising less than 10% annually

•

Medicare Part D Influence

–

15 of 20 top products-generic (2006)

•

Roughly $30 billion of drug spending over next four years subject to

patent expiration

Taking the lead with the generic opportunity

Source: IMS; Business Insights, Future Growth Opportunities in Generics, Nov. 2006

Credit Suisse, Managed Care Initiation, Nov 2006

Drivers of Generic Growth

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

Real

people.

Real

results.

Biosimilars

•

Huge market potential

–

US biotech market >$40 billion

–

Global biosimilars >$10 billion by 2010

•

Biotech products expensive

•

Push by payers and patients for access

•

End of data / market exclusivity and patent protection

•

Kendle has biotech, toxicology and clinical development expertise

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

Real

people.

Real

results.

Kendle advantages for Biosimilars

•

Biotech expertise –

global

–

Considerable experience of designing comparability programmes

following manufacturing changes

•

Toxicology expertise –

global

–

Knowledge of requirements for acceptable non-clinical packages

•

Clinical expertise –

global

–

Experience of designing clinical development programmes

–

Operational expertise in running clinical studies

–

Phase I units (Morgantown & Utrecht)

•

Registered a biosimilar in Australia

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

Real

people.

Real

results.

Phase I leadership

•

Improve productivity of existing Phase I units

•

Successful expansion of customer base in Morgantown

•

Business development cycle

•

Acquisition strategy

Expand early stage capabilities

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

Real

people.

Real

results.

Mega trial delivery

Strong project leadership for large global trials

Geographic reach over five regions

Efficiency and productivity through technology

Workforce needs

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

Real

people.

Real

results.

Global Locations

North

America

•

Ann Arbor, MI

•

Chicago, IL

•

Cincinnati, OH

•

Cranford, NJ

•

Durham, NC

•

Los Angeles, CA

•

Morgantown, WV

•

Old Lyme, CT

•

Rockville, MD

•

Wilmington, NC

Europe

•

Belgium

•

Bulgaria

•

Czech Republic

•

England

•

France

•

Germany

•

Israel

Asia

Pacific

•

Australia

•

China

•

India

•

Italy

•

Netherlands

•

Poland

•

Romania

•

Russia

•

Scotland

•

Spain

•

Sweden

Africa

•

South Africa

Latin

America

•

Argentina

•

Brazil

•

Chile

•

Colombia

•

Mexico

•

Peru

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

Real

people.

Real

results.

Patient Access

Rest-of-

World 9 %

Europe

23%

Asia/Pacific

U.S.

60%

Source: Jefferies, CRO Survey, March 2007

U.S.

40%

Asia/Pacific

19%

Europe

25%

Rest-of-World

16 %

Allocation of development spending by

global

region

–

current

Expected development spending

allocation by 2010; significant increase

in A/P, ROW

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

Real

people.

Real

results.

Enhanced Structure 2007

Driving Global Presence

Latin America grows from 3% of

total revenue 2006 to 5% of total

revenue in Q3 YTD 2007

Q3 YTD 2007

2006

Revenue moves away from US into

global markets with a shift from 55%

in 2006 to 50% in Q3 YTD 2007

55%

50%

Q3 YTD 2007

2006

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

Real

people.

Real

results.

Asia/Pacific leadership and expansion

•

New experienced leadership

•

Attractive growth projections

•

Establish A/P regional office, build regional team, expand presence

•

Deliver on current projects and commitments

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

Real

people.

Real

results.

Trial Leadership

•

Project leadership around global core standards, executed with

local understanding

•

Centralized organization with global reach and local expertise

Global business execution

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

Real

people.

Real

results.

Technology

•

Electronic Data Capture

–

Adaptive Trial Design

•

Enterprise Resource Planning System Implementation

Increase efficiency and productivity

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

Real

people.

Real

results.

Financial Profile

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

Real

people.

Real

results.

Four-Year Financial History

-$0.10

$0.27

$0.78

$0.93

2003

2004

2005

2006

1.40%

3.90%

8.50%

10.00%

2003

2004

2005

2006

$9,361

$19,176

$36,301

$45,348

$5,000

$10,000

$15,000

$20,000

$25,000

$30,000

$35,000

$40,000

$45,000

$50,000

2003

2004

2005

2006

REVENUE

EPS –

Pro forma *

OPERATING MARGIN –

Pro forma **

ADJUSTED EBITDA *

*Pro

forma

EPS

and

Adjusted

EBITDA

excludes

2006

the

impairment

charge

customer

relationship

asset;

2005

the

reversal

the

valuation allowance and write off of deferred state income taxes; and in 2003 the impairment charge to reduce the value of KendleWits

** Operating Margin –

Pro forma excludes in 2006 the impairment charge on a customer relationship asset

$156,221

$172,888

$202,032

$283,471

$50,000

$100,000

$150,000

$200,000

$250,000

$300,000

2003

2004

2005

2006

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

Real

people.

Real

results.

Strong Growth in Net Sales

2004

+32%

-5%

2005

+27%

+78%

141

*Includes acquisition of Charles River Laboratories Clinical Services as of Aug. 16, 2006.

2006

+22%

+92%

148

2003

+29%

+18%

136

+74%

152

+127%

2007

+9%

-56%

-12%

+36%

+34%

+150%

+71%

+19%

168

+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

Real

people.

Real

results.

*Includes acquisition of Charles River Laboratories Clinical Services as of Aug. 16, 2006.

+105%

2004

2007

2003

190

256

+32%

342

+34%

273

+33%

350

+28%

2005

300

+33%

+97%

590

323

+35%

700

+104%

659

+117%

758

2006

225

194

+5%

-7%

-9%

-5%

+2%

+18%

+32%

+31%

174

170

183

206

240

Strong Growth in Backlog

+41%

831

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

Real

people.

Real

results.

Growth in Revenues

* Peer Group includes PPD, Parexel, PRA and ICON.

**Includes acquisition of Charles River Laboratories Clinical Services as of Aug. 16, 2006.

21.2%

10.6%

10.7%

25.3%

2004

2005

13.6%

16.8%

18.9%

40.3%

2006

19.1%

59.7%

Q1 2007

21.1%

Peer

Group*

Kendle

Peer

Group*

Kendle

Peer

Group*

Kendle

Peer

Group*

Kendle

Peer

Group*

Kendle

57.5%

Q2 2007

21.8%

Peer

Group*

Kendle

Q3 2007

33.0%

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

Real

people.

Real

results.

Operating Margin Comparison

*Peer

Group

includes

PPD,

Parexel,

PRA

and

ICON.

Note:

PRA

excluded

from

2007,

they

have

not

publicly

released

earnings.

** Pro forma operating margin for full year 2006 excludes charges for stock option expense in accordance with FAS 123R, amortization of

acquired intangibles, other acquisition costs and severance costs, as well as an impairment charge on a customer relationship asset.

*** Pro forma operating margin for Q1 2007 and Q2 2007 excludes charges for the amortization of acquired intangibles. Q3 2007 also

excludes the write-off of deferred financing fees related to the Company’s term debt associated with the CRL CS acquisition.

2006

13.9%

12.0% **

7.1%

2004

13.4%

3.9%

2005

14.1%

8.5%

14.2%***

Q1 2007

13.1%

13.2%

Peer

Group*

Kendle

Peer

Group*

Kendle

Peer

Group*

Peer

Group*

Kendle

Peer

Group*

Kendle

Q2 2007

12.2%***

13.2%

11.1%

Peer

Group*

Kendle

Q3 2007

15.2%***

14.2%

12.5%

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

Real

people.

Real

results.

Reconciliation of Non-GAAP Data

2003

2006

Amounts in Millions

* Non

Cash

Adjustments

represent

for

2006

the

impairment

charge

customer

relationship

asset;

for

2005

the

reversal

the

valuation allowance and write off of deferred state income taxes; and for 2003 the impairment charge to reduce the value of KendleWits

TWELVE MONTHS ENDED DEC. 31,

2004

2005

NET INCOME

INCOME TAXES

INTEREST EXPENSE

INTEREST INCOME

DEPRECIATION & AMORTIZATION

NON CASH ADJUSTMENTS*

ADJUSTED EBITDA

$(1,690)

884

1,039

(334)

9,057

405

$9,361

$3,572

6,053

776

(400)

9,175

$19,176

$10,674

17,815

460

(1,019)

7,991

380

$36,301

$8,530

13,373

6,781

(1,939)

10,403

8,200

$45,348

Real people. Real results.

Kendle International (KNDL) Inactive 8-KRegulation FD Disclosure