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Candace Kendle, PharmD, Chairman and CEO Driving Global Connectivity…………………….. Chris Bergen, MBA, President and COO …………………………………………………………. Martha Feller, PhD, Senior VP, Global Clinical Devpt Medical Affairs…………………………………Thomas Smith, MD, VP, Medical Affairs eClinical Focus……………………………… Sylva Collins, PhD, VP, Global Biometrics Powering Performance…………………………... Karen Crone, VP, Global Human Resources Financial Profile…………………………………… Buzz Brenkert, MBA, Senior VP and CFO Questions and Answers……………………….… Candace Kendle, PharmD, Chairman and CEO and Kendle Management Team Closing Remarks………………………………...… Candace Kendle, PharmD, Chairman and CEO Safe Harbor: 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. 3 Slide4: 4 Slide5: 5 Market Influences Slide6: Source: Tufts Center for the Study of Drug Development, 2006 6 Rising Randamp;D and Fewer new Compounds Biotech Growth: Worldwide biotech Randamp;D expenditure forecast to increase substantially Demand for outsourcing from biotechs will rise as new therapies move from preclinical to clinical phases Biotech Growth 7 Source: Business Insights, The CRO Market Outlook, May 2007 Global biotech Randamp;D expenditure, 2004-2010e Total Randamp;D expenditure (Sbn) Year Healthcare Cost Pressure: Third-party payers are increasingly applying conditions for reimbursement for high-cost/impact drugs: Prior authorization Step therapy Indication restrictions Quantity limits Source: Tufts Center for the Study of Drug Development, Outlook 2007 Healthcare Cost Pressure 8 Conditions of reimbursement for prescription drugs are growing Share of global top 100 selling drugs with conditions applied to reimbursement 2002 2005 Percentage Generic Industry: A steady increase in the number of generic drug applications received and approvals Source: CDER Report to the Nation, 2005 Generic Industry 9 Generic Drug Applications Received Generic Drug Approvals Months Number Calendar year Median times, approvals Calendar year Applications received (workload in future years) Number Preclinical/Phase I OpportunityPhase I Compounds in Development by Year, Month : Preclinical/Phase I Opportunity Phase I Compounds in Development by Year, Month Source: Goldman Sachs, Pharmaceutical Services, Jan. 2007 10 Fastest growing segment; Preclinical/Phase I a $6.9 billion market by 2010 7.6% 3-year CAGR 6.8% y/y growth Slide11: Source: Thomson CenterWatch, State of the Clinical Trials Industry, 2006 11 Government Opportunity Sources of Trial Funding $10,438 $U.S. in Millions Year $2,145 $434 Total: $13,017 $11,975 $2,412 $493 Total: $14,880 $14,490 $3,614 $544 Total: $18,648 $19,286 $6,639 $630 Total: $26,555 Source: Thomson CenterWatch Analysis, 2004; BBC, 2003 Customer Needs: 12 Customer Needs Patient Access: Patient Access Source: Jefferies, CRO Survey, March 2007 13 Allocation of development spending by global region – current Expected development spending allocation by 2010; significant increase in A/P, ROW Pharma Survey: Vendor relationships, Electronic Data Capture (EDC) and functional outsourcing selected as top three strategies to improve Randamp;D productivity/efficiency Preferred provider agreements and centralized sourcing groups also important in improving trial efficiency Source: Jefferies, CRO Survey, March 2007 Pharma Survey 14 % of total respondents Therapeutic Expertise: Therapeutic Expertise Source: Goldman Sachs Research estimates, Company data. 15 Global eClinical Trials Market: Revenue Forecasts (World), 2002-2012: Global eClinical Trials Market: Revenue Forecasts (World), 2002-2012 Source: Frost andamp; Sullivan 16 Slide17: About Kendle: About Kendle Company Overview FY06 Net Base Revenue1 by Brand Founded 1981 Phase I-IV focus Four brands: Global Clinical Development Global Regulatory Affairs Global Biometrics Global Late Phase 48 offices in 26 countries on six continents Therapeutic focus areas: Oncology, CNS and Anti-infectives Total Net Revenue = $283 million Notes: 1 Excludes acquisition revenue 2 9.3% of revenues are from Phase I 18 Phase I-IV Clinical Development Focus: Phase I-IV Clinical Development Focus Late Stage 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 andamp; 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 19 Medical Affairs Corporate Imperatives – Successes: 20 Corporate Imperatives – Successes Maximize quality and increase capability Drive growth and profitability Focus on our customer and build our brand Develop talent and reward performance Financial Total Q2 2007 record revenues of $97.8 million Business authorizations all-time high at $758 million Improved operating margin 11.1% (GAAP) andamp; 12.2% (proforma) Customer Elephant trials awarded increased three-fold 2005-2006 Phase III projects awarded increased 32% 2005-2006 Increased Hit Rate for 2006 and YTD 2007 Operational Driving growth in Phase III, global, full-service projects Strong platform in top regions rated highest in demand CRL CS integration successfully completed ahead of schedule and within budget Personnel Combined global organization Successful integration of key individuals in mgmt roles Significantly strengthened therapeutic expertise Defining a Winning Organization: Defining a Winning Organization Category leadership Global 'elephant' project capability Accelerated organic growth Project delivery model Blended organic growth and continued acquisitions BUS Bulk-Up Strategy TLS Therapeutic Leadership Strategy Share growth I-IV GAS Geographic Acquisition Strategy 21 Therapeutic Leadership = Market Needs: Therapeutic Leadership = Market Needs Kendle’s 2006 Therapeutic Mix New Product launches by therapeutic area, 2006-09E 22 Geographic Revenue Distribution: Geographic Revenue Distribution Revenue Q2 2006 Revenue Q2 2007 23 Consistently Recognized for Excellence: Consistently Recognized for Excellence 'Top CRO To Work With' -- Thomson CenterWatch 2007 Survey of U.S. Investigative Sites 'Best CRO' – Independent Panel for Scrip World Pharmaceutical News 2006 Development Operations Strategic Supplier Excellence Award – Pfizer 2006 North American CRO Business Development Strategy Leadership of the Year Award – Frost andamp; Sullivan 24 Slide25: Slide26: Global presence Data access (management information) Global management orientation Global approach to Medical Affairs EDC expertise Staff recruiting and retention 26 Global Connectivity Slide27: Strategic breadth and depth Local knowledge and understanding Cultural Medical Regulatory 27 Global Presence Value of Global Presence: Value of Global Presence 28 Slide29: TrialMD® – Investigator database KendleConnect™ – Patient registration/screening/referral TrialWatch™ – Clinical trials management information system eReg document submission Enrollment data Monitoring data Monitoring reports Argus – Adverse event management system TriaLine® – Interactive voice response system Financials Global pricing model Time reporting 29 Data Access (Management Information) Global Management Orientation: Global Management Orientation Global leadership/management/organization Organizational capacity Staff training and development 30 Slide31: Leadership Drug development expertise Global experience Process Focus Global standardized processes Project Management PL accountability Senior management engagement, support and oversight Performance metrics 31 Global Leadership/Management/Organization Project Management - Organizational Structure: Project Management - Organizational Structure 32 Organizational Capacity: Organizational Capacity Global resource database Selection of all project teams Local medical knowledge Expertise in Oncology, CNS, CV, Endocrinology, Infectious diseases, pediatrics Medical Affairs organization Local regulatory and safety knowledge Regulatory consulting and submission expertise Repository of safety and local regulatory data Global Strategic Consulting Group Internal advisors, trainers and consultants 33 Staff Training and Development: Staff Training and Development Training of future Kendle leaders CEO-sponsored Live, interactive sessions Market dynamics and corporate vision/strategy All Brands and Support Units represented Training of all associates Comprehensive (general and project-specific) Convenient Single learning portal, Kendle College and SkillSoft Performance metrics 34 Slide35: Medical Affairs: Driving Service Excellence: Medical Affairs: Driving Service Excellence 36 Global Structure: Global Structure 37 Driving Global Success: Driving Global Success Successes acknowledged Changing needs realized Growing opportunities Allowing professional development 38 38 Slide39: eClinical Focus: eClinical Focus Clinical trials data traditionally collected using 'pencil and paper' CRFs (Case Report Forms) EDC technology transforming clinical trials management process 40 Market drivers: Market drivers Convergent forces of emerging technology, financial pressure and consumer demand compelling CROs to carry out drug development faster, better and more cost effectively Companies looking for tools to increase productivity 'EDC currently used in 30–40% of all new clinical trials and expected to be used in nearly 70% of all new trials by 2012'* * Frost and Sullivan as quoted by Jefferies, December 15, 2006 41 CRO Data Management Market Size Projections ($ Billion)Assume 17% CAGR in CRO market, and 18.5% in EDC: CRO Data Management Market Size Projections ($ Billion) Assume 17% CAGR in CRO market, and 18.5% in EDC 42 EDC Benefits: EDC Benefits EDC is a means to a goal Faster Database lock in days rather than weeks with paper Better quality 90%+ reduction in number of data queries Lower costs Customers looking for cost savings and willing to use standards Process standardization resulting in greater efficiencies and reduced costs 43 Kendle Approach: Kendle Approach ClinPhone EDC (DataLabs) is preferred system We support all aspects of EDC with ClinPhone eCRF development, training, Help Desk, Data Management Economies of scale through standardization Efficiency and cost savings for customer and Kendle 44 Portfolio: Standardization Key to Economies of Scale: Portfolio: Standardization Key to Economies of Scale Customer economies of scale Customers use standard eCRFs (customer’s own) Minimize eCRF programming and validation costs Kendle economies of scale Encourage customer use of Kendle standards and processes Generic economies of scale Dramatic increase in efficiency as Kendle increases portfolio of EDC studies 45 Portfolio: Standardization Key to Economies of Time: Portfolio: Standardization Key to Economies of Time Standardized eCRFs reduce study start-up time Standardized tables and listings reduce statistical analysis time Speed enables adaptive designs of clinical trials 46 Adaptive Trial Designs: Adaptive Trial Designs The really exciting possibility enabled by being fast is the whole area of adaptive trial designs Adaptive trial designs are those in which the results of an interim analysis from an ongoing trial are used to change the course of the trial Adaptive designs have the potential to transform clinical development 47 Adaptive Designs: Adaptive Designs Possible study design changes Delete or add dosing levels Early termination for success or futility Sample size re-estimation Seamless phase I, II, III trials 48 Slide49: Shaping Kendle Culture: Shaping Kendle Culture High touch High performance High engagement Global connectivity 50 The Kendle Stamp Driving Workforce Planning – China: Driving Workforce Planning – China Developing regional build/buy strategies Broaden labor pool – Earn more share Attract experienced talent and new entrants Leverage local customs/institutions Leverage top attraction drivers Attraction drivers Compensation – Multiple step increases based on increased competence Development opportunities – Kendle certification, co-monitoring and mentoring Future career opportunities – Multiple levels within career band, PL upside Meritocracy – Kendle performance management system, semi-annual merit treatment Health benefits – Partnering for initial plan design and differentiation (e.g., supplemental medical or housing benefits) 51 Increasing Retention: Increasing Retention 52 Mindset Associate Preparedness Associate andamp; Manager relationship + + Monthly reporting Brand/SU targets Attrition cost analysis Associate engagement index Early warning system Induction/touch points SOPs and WIs CRA and PL training Learning/career paths Mentoring Kendle Performance System Associate communication Management development Leadership development Linking Associate Engagement to Financial Performance: Linking Associate Engagement to Financial Performance 53 Slide54: Four-Year Financial History: Four-Year Financial History REVENUE EPS – Proforma * OPERATING MARGIN – Proforma ** ADJUSTED EBITDA * Proforma EPS and Adjusted EBITDA excludes in 2006 the impairment charge on a customer relationship asset; in 2005 the reversal of 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 – Proforma excludes in 2006 the impairment charge on a customer relationship asset 55 Strong Growth in Gross Sales: Strong Growth in Gross Sales 2004 2007 $Million *Includes acquisition of Charles River Laboratories Clinical Services as of Aug. 16, 2006. 2003 53 73 +38% 2005 * 2006 70 53 +18% -48% -6% +15% +0% +75% +48% +27% 56 Strong Growth in Net Sales: Strong Growth in Net Sales $Million 2004 2005 * *Includes acquisition of Charles River Laboratories Clinical Services as of Aug. 16, 2006. 2006 2003 2007 +9% -56% -12% +36% +34% +150% +71% +19% 57 Slide58: *Includes acquisition of Charles River Laboratories Clinical Services as of Aug. 16, 2006. +105% 58 Strong Growth in Backlog Net Book-to-Bill Ratio: Net Book-to-Bill Ratio *Peer Group includes PPD, Parexel, PRA and ICON. Note PRA is excluded from 2003. 2003 2004 2005 2006 Q1 07 Q2 07 0.5 0.6 0.7 0.8 0.9 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 59 Growth in Revenues: 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% 57.5% Q2 2007 60 Operating Margin Comparison: Operating Margin Comparison *Peer Group includes PPD, Parexel, PRA and ICON. ** 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. 13.1% 2006 13.9% 12.0% ** 7.1% 2004 13.4% 3.9% 2005 14.1% 8.5% 11.1% 14.2%*** Q1 2007 13.1% 13.2% Q2 2007 12.2%*** 13.2% 11.1% 61 Financial Results: Financial Results THREE MONTHS ENDED June 30 2007 2006 (000s) Pro forma diluted earnings per share for 2007 excludes amortization of acquired intangibles related to the CRL CS acquisition. NET SERVICE REVENUES* OPERATING INCOME* OPERATING MARGIN DILUTED EARNINGS PER SHARE PRO FORMA DILUTED EARNINGS PER SHARE OPERATING CASHFLOW* EBITDA* $97,802 $10,879 11.1% $0.29 $0.34 $9,938 $14,086 $62,086 $6,396 10.3% $0.29 $0.29 $4,489 $8,008 62 Financial Results: Financial Results SIX MONTHS ENDED June 30 2007 2006 NET SERVICE REVENUES* OPERATING INCOME* OPERATING MARGIN DILUTED EARNINGS PER SHARE PRO FORMA DILUTED EARNINGS PER SHARE OPERATING CASHFLOW* EBITDA* $193,241 $23,368 12.1% $0.57 $0.66 $24,364 $28,245 $121,839 $13,674 11.2% $0.62 $0.62 $7,455 $16,824 (000s) Pro forma diluted earnings per share for 2007 excludes amortization of acquired intangibles. 63 Balance Sheet Highlights: Balance Sheet Highlights CASH AND AVAILABLE-FOR-SALE SECURITIES WORKING CAPITAL TOTAL ASSETS CREDIT FACILITY DEBT SHAREHOLDERS’ EQUITY $22.3 $56.4 $455.1 $199.5 $140.1 $25.1 $46.6 $486.5 $183.5 $145.8 AS OF Amounts in millions JUNE 30, 2007 DEC. 31, 2006 64 2007 Guidance: 2007 Guidance * Millions ** Excludes amortization of acquired intangibles, acquisition costs, severance costs, impairment charge on a customer relationship asset, and state tax valuation allowances ***Excludes amortization of intangibles associated with the CRL Clinical Services acquisition and the financing fees write -off 2006 2007 est Growth Net Service Revenue* $283 $400 – $420 41.1% – 48.1% EPS $0.58 $1.32 – $1.52 127.6% – 162.1% Pro forma EPS $1.13 ** $1.72 – $1.92*** 46.2% – 61.9% 65 Convertible Notes Offering Summary : Convertible Notes Offering Summary 66 Slide67: Dilution from Convertible Notes 67 Reconciliation of Non-GAAP Data : Reconciliation of Non-GAAP Data SIX MONTHS ENDED June 30 2007 2006 NET INCOME INCOME TAXES INTEREST EXPENSE INTEREST INCOME DEPRECIATION AND AMORTIZATION EBITDA $4,290 2,518 51 (629) 1,778 $8,008 $9,189 5,157 114 (1,180) 3,544 $16,824 Amounts in 000s THREE MONTHS ENDED June 30 2006 $4,332 2,252 4,328 (457) 3,631 $14,086 2007 $8,535 4,616 8,672 (767) 7,189 $28,245 68 Reconciliation of Non-GAAP Data : Reconciliation of Non-GAAP Data 2003 2006 Amounts in 000s * Non Cash Adjustments represent for 2006 the impairment charge on a customer relationship asset; for 2005 the reversal of 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 andamp; 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 0 $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 69 Defining a Winning Organization: Defining a Winning Organization Category leadership Global 'elephant' project capability Accelerated organic growth Project delivery model Blended organic growth and continued acquisitions BUS Bulk-Up Strategy TLS Therapeutic Leadership Strategy Share growth I-IV GAS Geographic Acquisition Strategy 70 Slide71: Questions and Answers Slide72: You do not have the permission to view this presentation. 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