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Executive Chairman Dr. John Climax - PowerPoint PPT Presentation


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Executive Chairman Dr. John Climax. CEO Peter Gray. ICON Central Laboratories President Bob Scott-Edwards. President Corporate Development Bill Taaffe. ICON Development Solutions President Dr Thomas Frey. ICON Clinical Research Global President Dr John Hubbard.

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Executive Chairman Dr. John Climax


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    1. Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards President Corporate Development Bill Taaffe ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray COO US Malcolm Burgess VP Corporate QA Jo Coyle ICON Medical Imaging Chief Executive Dr Ted Gastineau Commercial VP Brian O’Dwyer VP Global IT Mike McGrath Snr VP Global BD Elizabeth Thiele VP Strategic HR Eimear Kenny Snr VP Global Medical Suzanne Gagnon VP Corporate Training & Development Anne Wesler VP Global Data Management Tom O’Leary VP Market Development Simon Holmes

    2. COO US Malcolm Burgess Snr VP Global BD Elizabeth Thiele Snr VP Global Medical Suzanne Gagnon VP Global Data Management Tom O’Leary Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards President Corporate Development Bill Taaffe ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray VP Corporate QA Jo Coyle ICON Medical Imaging Chief Executive Dr Ted Gastineau Commercial VP Brian O’Dwyer VP Global IT Mike McGrath VP Strategic HR Eimear Kenny VP Corporate Training & Development Anne Wesler VP Market Development Simon Holmes

    3. Forward Looking Statements Certain statements contained herein including, without limitation, statements containing the words “believes,” “anticipates,” “intends,” “expects” and words of similar import, constitute forward-looking statements concerning the Company's operations, performance, financial condition and prospects. Because such statements involve known and unknown risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    4. Global Full Service Clinical Development Global Clinical EU 38% Q4 Revenue by Region ROW 9% US 53%

    5. ICON’s Global Clinical Footprint North America 2 Countries 17 Offices >1,900 Staff Eastern Europe / Russia 8 Countries 9 Offices > 350 Staff Japan 1 Country 2 Offices >80 Staff Western Europe / Africa 10 Countries 13 Offices >1,600 Staff Asia Pacific 8 Countries 10 Offices >450 Staff Latin America 5 Countries 5 Offices >170 Staff Projects in 60+ Countries

    6. Market Environment

    7. Strong Market Environment with... • Continued R&D Spending Growth. • Phase II / III pipelines strengthening • Increased Outsourcing • Being accelerated by activity & funding in Biotech / Speciality • Globalisation of clinical research • New strategic thinking / cost containment • Increasing Regulation • More patients/ more studies • Post marketing surveillance 5

    8. Preclinical Compounds in Development The Pipeline continued to fill in 2007 Up ≈ 23% Source: Pharmaprojects

    9. Phase I Compounds in Development The Pipeline continued to fill in 2007 Up ≈ 22% Source: Pharmaprojects

    10. Phase II/IIICompounds in Development The Pipeline continued to fill in 2007 Up ≈ 14% Source: Pharmaprojects

    11. US Biotech Funding Environment continued to grow Biotech fundraising (excluding debt financing) $Billion Source: Burrill and Company

    12. ICON in this Market Environment

    13. Gross RFP Value by Market Segment (Including RFPs that never progress to award) RFP Value by Market Segment • 2007 Value • 54% Increase / PY • Size of Projects • 41 > 20 Million • 168 > 5 Million • 959 < 5 Million 14

    14. Strong RFP volume growth, with increasing average proposal value…

    15. …which has led to increasing numbers of awards greater then $5 million.

    16. Overall, Strong Gross Business wins has led to… ICON Gross Business Wins - Last 10 Quarters ($ millions)

    17. .. excellent Net New Business wins and very strong book to bill ratios… Book to Bill Ratio Net Business Wins

    18. Up 49% YoY Up 38% YoY …leading to record Total Backlog levels. ($ millions)

    19. From this backlog, coverage of next 4 quartersrevenues is robust…….. % coverage of next 4 quarters forecast revenues Value of backlog forecast to be earned in next 4 quarters

    20. This has led to a diversified customer base…… Client Diversity 2005, 2006, 2007 2007 - New Business by Customer Segment

    21. ….and broad therapeutic expertise. Revenue by Therapeutic Area 2007

    22. Strategy

    23. ICON’s Core Strategy is Organic Growth,with acquisitions made to add new services or scale. • Acquisitions to date - 11 • Revenues acquired $114m • Staff acquired – 1,100 • => Organic growth >80% • Capitalise on market fundamentals to drive organic growth in all business units. • Pursue acquisitions to enhance depth and scale of current operations and to add additional complementary services e.g. • Phase I - US • Bioanalytical / Biomarkers • Therapeutic specialists • Safety / Phase IV • Patient Recruitment • Staffing • Cross-sell services to grow sales and margin

    24. Key Strategic Trends • Strategic v Tactical Outsourcing • More large companies are seeking to use outsourcing strategically rather than tactically. • ICON fully engaged. • Globalisation • Growth in Eastern Europe, Latin America and Asia as a venue. • ICON growing rapidly in these regions • Greater Scientific Involvement • Customers seeking greater scientific input from CROs • ICON has added TAGS, IDS, Imaging, new Lab technologies etc. to respond. • EDC • Estimated that over 40% of clinical trials now use EDC • 49% of ICON’s Data Management activity in 2007 was EDC

    25. COO US Malcolm Burgess Snr VP Global BD Elizabeth Thiele Snr VP Global Medical Suzanne Gagnon VP Global Data Management Tom O’Leary Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards President Corporate Development Bill Taaffe ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray VP Corporate QA Jo Coyle ICON Medical Imaging Chief Executive Dr Ted Gastineau Commercial VP Brian O’Dwyer VP Global IT Mike McGrath VP Strategic HR Eimear Kenny VP Corporate Training & Development Anne Wesler VP Market Development Simon Holmes

    26. Net Revenue CAGR of over 30% since 2002 22% Forecast for ‘08 CAGR 32% *Mid Point of 2008 Guidance issued December, 2007

    27. Earnings Per Share Growth CAGR 26% (E) *Mid Point of 2008 Guidance issued December 2007

    28. Recent Financial Performance ($ millions, except EPS; includes stock option expense)

    29. Recent Financial Performance ($ millions)

    30. Margin improvement is a key focus • Approx. 25% of ICON’s business is generating single digit margins • Further margin growth in Lab • Improve performance from Phase I and Consultancy businesses • Bring Japan to higher profitability • Expand margins in Phase II – IV through leverage as growth moderates. • Currency Movements creating some “Headwinds” 5

    31. Summary Balance Sheet and Cash Flow ($ millions)

    32. Executive Chairman Dr. John Climax CEO Peter Gray ICON Central Laboratories President Bob Scott-Edwards President Corporate Development Bill Taaffe ICON Development Solutions President Dr Thomas Frey ICON Clinical Research Global President Dr John Hubbard ICON Contracting Solutions President Sean Leech Chief Financial Officer Ciaran Murray COO US Malcolm Burgess VP Corporate QA Jo Coyle ICON Medical Imaging Chief Executive Dr Ted Gastineau Commercial VP Brian O’Dwyer VP Global IT Mike McGrath Snr VP Global BD Elizabeth Thiele VP Strategic HR Eimear Kenny Snr VP Global Medical Suzanne Gagnon VP Corporate Training & Development Anne Wesler VP Global Data Management Tom O’Leary VP Market Development Simon Holmes

    33. The Globalisation of Clinical Research: Challenges and Opportunities in Argentina, Brazil, Russia, China and India John W. Hubbard, Ph.D., FCP Global President, ICON Clinical Research

    34. Products in Development by Therapeutic Area Source – BioPharmInsight.com, 2007

    35. Pharma & Device Industry Challenges Trend Driver • Treatment naïve patients Cost perpatient Cost per trial Cost perinvestigator • Qualified investigators Cost ofclinicaldevelopment Complexity of protocols • Number of procedures, and type of inclusion/exclusion criteria Infrastructure cost • Number and size of trials • Regulatory requirements Global trend for higher costs, more patients and experienced clinical investigators! Source McKinsey 2004

    36. Why Conduct Global Clinical Trials? • Access to treatment naïve patients, or patients who have only been treated with older medications • Emergent disease populations, e.g., Type II diabetes, treatment resistant infections such as HIV, tuberculosis, hepatitis B & C, and various forms of cancer, and cardiovascular disease • Cost and time benefits: Faster patient recruitment and lower cost base • Since 1990, global clinical research has grown from 28 to 79 countries and the amount of FDA regulated research has increased 16-fold • ICH E5 regulations allow the use of foreign data in new drug submissions PharmafocusAsia, 2005

    37. Drivers of Country Selection • Medical practice • Regulatory process • Commercial and post-marketing value • Cost of the trial • Disease demographics • Speed of enrollment • Quality, quality, quality Quality is the key driver: If a country cannot deliver quality, all other benefits are irrelevant

    38. ICON’s Global Clinical Footprint Eastern Europe / Russia 8 Countries 9 Offices 339 Staff North America 2 Countries 17 Offices 1896 Staff Japan 1 Country 2 Offices 72 Staff Western Europe / Africa 10 Countries 13 Offices 1554 Staff Asia Pacific 8 Countries 10 Offices 448 Staff Latin America 5 Countries 5 Offices 166 Staff Projects in 60+ Countries

    39. Key Countries for Clinical TrialsBased on the Overall Country Attractiveness Index1 6.88 4.90 5.26 5.55 5.58 6.10 1A.T. Kearney Attractiveness Index , Pharmaceutical Executive Supplement, 2006

    40. Clinical Research in Russia, Argentina, Brazil, China and India: Opportunities and Challenges

    41. ICON’s Clinical Trial Experience in Russia

    42. Russia: Opportunities and Challenges • Opportunities • Population of more than 142 million, with only 274 ongoing multi-national clinical trials (only 5% of the clinical research potential) • Large urban hospitals and medical centers • 768 Clinical sites registered by the Federal Service for Healthcare and Social Development in the Russian Federation • High average patient enrollment rates of 4.7 patients/site/month • FDA has conducted 36 audits since 1995 and ranks #1 in quality amongst other E7 countries • Low cost relative to Western EU and the US • Relatively straight forward regulatory and clinical site contracting process • Challenges • New regulatory requirements regarding the shipment of blood, DNA, and tissue samples • Rapidly maturing marketplace Sources: UBC International Clinical Trials, 2007

    43. Russia versus U.S. in Clinical Research Key:Red color = An area of development or current limitation.

    44. ICON’s Clinical Trial Experience in Latin America

    45. Latin America: Opportunities and Challenges • Opportunities • The seven main Latin American markets add up to 448 million people with a GDP of US $2.5 trillion in 2006. • Highly concentrated: 70% urban / mega-cities • Only two main languages • Counter-season enrollment in Southern Hemisphere • Led by Mexico, Brazil and Argentina, they are expected to represent a market value of US $52 billion at retail prices by 2011. Sources: Espicom / PWC

    46. Latin America: Opportunities and Challenges • Between 1995 & 2000, the number of clinical trials executed in the region rose by a factor of ten. • High quality of medical practice and experienced clinical investigators • Growing clinical trails sector • Development of dedicated CT sites, ERBs, SMOs • Expansion of CROs and Pharma clinical operations • Availability of GCP/CRA/SC training Courses • Support services: central labs, CTM logistics, QA consultants • Challenges • Regulatory agencies are “stretched” due to lack of resources to meet the clinical trial demand • Longer regulatory start-up in some countries (e.g., Brazil) • Evolving regulatory environment • Some agencies are recognizing the need to adapt their regulations harmonization initiatives, which could enhance the attractiveness of the region Sources: Espicom / PWC

    47. Latin America versus U.S. in Clinical Research Key:Red color = An area of development or current limitation.