dec.11, 2008 raymond james boston fall investors conference boston, massachusetts
TRANSCRIPT
Dec.11, 2008
Raymond James Boston Fall Investors ConferenceBoston, 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.
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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
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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
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Our vision
“Best-in-class” provider of clinical
development services to the biopharmaceutical
industry through broad therapeutic
and geographic expertise
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Our strategy
Our vision
Operational continuity and leverage via
the matrix
Customer and business expansion to accelerate
growth
Infrastructure growth to
drive global connectivity
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Operational continuity and leverage
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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
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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
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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
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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
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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
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Customer and business expansion
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Early Stage opportunities
Geographic expansion
Business expansion
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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
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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
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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
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Infrastructure growth to drive global connectivity
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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
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Financial profile
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Q3 2008 financial highlights
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Growth in revenues
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Operating margin comparison
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Strong growth in EPS
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Solid growth in net sales
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Strong growth in backlog
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2008 revised guidance
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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