icon plc. 2008 raymond james institutional investors conference – march 4 th , 2008

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1 ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008 Mr. Peter Gray - CEO

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ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008 Mr. Peter Gray - CEO. Forward Looking Statements. - PowerPoint PPT Presentation

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Page 1: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

1

ICON Plc.2008 Raymond James Institutional Investors Conference – March 4th, 2008

Mr. Peter Gray - CEO

Page 2: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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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.

Forward Looking Statements

Page 3: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Global Full Service Clinical Development

US 53%

EU 38%

ROW 9%

Q4 Revenue by Region

GlobalClinical

Page 4: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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ICON Latin America5 countries5 Offices153 Clinical Staff

ICON North America2 Countries23 Offices2605 Clinical Staff

ICON Europe/Africa17 Countries20 Offices1980 Clinical Staff

ICON Asia Pacific9 Countries12 Offices478 Clinical Staff

ICON Global - Projects in 50+ Countries

North America2 Countries17 Offices>1,900 Staff

Western Europe / Africa

10 Countries13 Offices>1,600 Staff

Asia Pacific8 Countries10 Offices>450 StaffLatin America

5 Countries5 Offices>170 Staff

Projects in 60+ Countries

ICON’s Global Clinical Footprint Eastern Europe / Russia8 Countries9 Offices> 350 Staff

Japan1 Country2 Offices>80 Staff

ICON’s Global Clinical Footprint

Page 5: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Market Environment

Page 6: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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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

Page 7: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Preclinical Compounds in Development

4000

4100

4200

4300

4400

4500

4600

4700

4800

4900

5000

5100

5200

Sep-06

Oct-06

Nov-06

Dec-06

Jan-07

Feb-07

Mar-07

Apr-07

May-07

Jun-07

Jul-07

Aug

-07

Sep-07

Oct-07

Nov-07

Source: Pharmaprojects

Up ≈ 23%

The Pipeline continued to fill in 2007

Page 8: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Phase I Compounds in Development

880

930

980

1030

1080

1130

1180

1230

1280

1330

1380

Sep-06

Oct-06

Nov-06

Dec-06

Jan-07

Feb-07

Mar-07

Apr-07

May-07

Jun-07

Jul-07

Aug

-07

Sep-07

Oct-07

Nov-07

Source: Pharmaprojects

Up ≈ 22%

The Pipeline continued to fill in 2007

Page 9: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Phase II/III Compounds in Development

1800

1850

1900

1950

2000

2050

2100

2150

2200

2250

2300

2350

2400

Sep-06

Oct-06

Nov-06

Dec-06

Jan-07

Feb-07

Mar-07

Apr-07

May-07

Jun-07

Jul-07

Aug

-07

Sep-07

Oct-07

Nov-07

Source: Pharmaprojects

The Pipeline continued to fill in 2007

Up ≈ 14%

Page 10: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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$18.1

$22.4

$29.2

$33.1

$38.6

$0.0

$5.0

$10.0

$15.0

$20.0

$25.0

$30.0

$35.0

$40.0

$45.0

2003 2004 2005 2006 2007

$Bil

lio

n

Biotech fundraising (excluding debt financing)

Source: Burrill and Company

US Biotech Funding Environment continued to grow

Page 11: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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ICON in this Market Environment

Page 12: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

1212

RFP Value by Market Segment

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

2003 2004 2005 2006 2007 2008 2009 2010

(in m

illio

ns)

Total Large Pharma MidSize Pharma Biotech

2007 Value

54% Increase / PY

Size of Projects

41 > 20 Million

168 > 5 Million

959 < 5 Million

Gross RFP Value by Market Segment

(Including RFPs that never progress to award)

Page 13: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Strong RFP volume growth, with increasing average proposal value…

Number of Proposals

571

8871014

1118

400

600

800

1000

1200

2004 2005 2006 2007

Average Proposal Size ($ millions)

2.8 3.1 3.6

5.4

0

2

4

6

2004 2005 2006 2007

Page 14: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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

Number of New Awards Greater then $5 million

8 14

32

46

0

10

20

30

40

50

2004 2005 2006 2007

Page 15: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Overall, Strong Gross Business wins has led to…

$127

$165$186 $189 $193

$207

$245$264

$246

$366

Q3 05 Q4 05 Q1 06 Q2 06 Q3 06 Q4 06 Q1 07 Q2 07 Q3 07 Q4 07

ICON Gross Business Wins - Last 10 Quarters ($ millions)

Page 16: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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.. excellent Net New Business wins and very strong book to bill ratios…

$140

$171$166

$157$171

$223 $230

$344

$230

Q4 05 Q1 06 Q2 06 Q3 06 Q4 06 Q1 07 Q2 07 Q3 07 Q4 07

1.6

1.3

1.6 1.6

1.9

1.3 1.41.6

1.7

Net Business Wins Book to Bill Ratio

Page 17: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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…leading to record Total Backlog levels. ($ millions)

$633

$707

$772$815

$872

$963

$1,049

$1,125

$1,300

Q4 05 Q1 06 Q2 06 Q3 06 Q406 Q1 07 Q2 07 Q3 07 Q4 07

Up 38% YoY

Up 49% YoY

Page 18: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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From this backlog, coverage of next 4 quarters revenues is robust……..

$296 $307

$360

$395$415

$470

$542

$589

$493

Q4 '05 Q1 '06 Q2 '06 Q3 '06 Q4 '06 Q1 '07 Q2 07 Q3 '07 Q4 '07

76%

76% 76% 76%

77%77%76% 76%

77%

Value of backlog forecast to be earned in next 4 quarters

% coverage of next 4 quarters forecast revenues

Page 19: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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This has led to a diversified customer base……

42.6%

34.6%

30.0%

62.7%

51.1%47.0%

81.4%

72.0%

66.0%

7.8%9.6%12.3%

FY To May 2005 2006 2007

Largest Client

Top 5

Top 10

Top 25

Client Diversity 2005, 2006, 2007

2007 - New Business by

Customer Segment

Page 20: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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….and broad therapeutic expertise.

Revenue by Therapeutic Area 2007

Page 21: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Quality

Page 22: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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From 2000 – 2006 ICON has been the fastest Growing CRO, and this has continued in 2007..

8.4%10.5%

15.3%16.5%

22.4%20.5%

33.4%

ICON PRA PPD CRO Ind KNDL CVD PRXL

* Source SEC Filings

(ICON Growth 2007 = 32%)

Page 23: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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…but Quality and Delivery remains our Key Focus.

Page 24: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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ISO9001:2000 Registered Since 1994.

• External assessment of ICON’s Global Quality System ¯ Group registration for the whole company

• Annual random surveillance audits across regional offices to monitor compliance - audit frequency is based on office size and number of services

• All new offices independently audited to attain registration¯ 2007 audit program

• USA: PA, FL, NC, CA-Irvine, CA-Redwood City• Europe: IRL, GER, SWE, RUS, HUN, POL, ITL*• ROW: South Africa, CAN, MEX*, ARG (*new offices registration audits)

• The following accreditations are maintained by ICON Laboratories¯ ISO 17025 ¯ CAP accreditation¯ CLIA (New York facility only)

Page 25: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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ICON Internal QA Audits – 2007

Division US EU ROW Total

Clinical Research 221 154 50 425

Central Lab 54 22 0 76

Development Solutions 30 220 0 250

Medical Imaging 23 0 0 23

Quality system audits 18 43 28 89

  346 439 78 863

We Live Quality Internally,….

Page 26: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Division Sponsor

Clinical Research 148

Central Lab 41

Development Solutions 31

Medical Imaging 18

  238

Client, Regulatory and ISO Audits – 2007

… Clients Check it,….

Page 27: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Office Date Region Auditing Authority Outcome

Redwood City, CA Oct 2003 US FDA No findings (no FDA 483)

New York City, NY Mar/Apr 2005 US FDA No findings (no FDA 483)

North Wales, PA May 2005 US FDA No findings (no FDA 483)

Nashville, TN Oct/Nov 2005 US FDA No findings (no FDA 483)

North Wales, PA Dec 2005 US FDA No findings (no FDA 483)

Nashville, TN Jan 2006 US FDA No findings (no FDA 483)

Eastleigh, UK Oct 2004 EU MHRA No critical findings

Dublin, Ireland Apr 2005 EU IMB No critical findings

Eastleign/Marlow, UK Sept 2007 EU MHRA No critical findings

Frankfurt. Germany Sept 2007 EULocal regulatory authority: RP Darmstadt

No critical findings

Singapore Oct 2005 ROWHSA - Health Services Authority of Singapore

No critical findings

…Regulatory Agencies Inspect it,….

Page 28: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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…and 3rd Parties Validate it

Survey Year Comments

William Blair / PharmaMediation

2004 Top CRO for quality and execution.

CenterWatch Survey of Investigative Sites

2005Top 3 CRO for Investigator relationships and site management.

Frost Sullivan 2006

Top 3 CRO for timely database lock and key attributes of overall quality, personnel expertise, therapeutic expertise, and project turnaround.

Thomson CenterWatch and William Blair

2007Vendor you most prefer working with based on quality.

Lehman Brothers 2007 Top CRO for quality of global execution.

SGS – ISO Audit AnnualPassed without significant comments since 1995

Page 29: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Strategy

Page 30: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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ICON’s Core Strategy is Organic Growth,with acquisitions made to add new services or scale.

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

Acquisitions to date - 11

• Revenues acquired $114m

• Staff acquired – 1,100

• => Organic growth >80%

Page 31: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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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

Page 32: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Financial Performance

Page 33: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Net Revenue CAGR of over 30% since 200222% Forecast for 2008

$327$297

$226$157

$456

$631

$760(E)

$0

$100

$200

$300

$400

$500

$600

$700

FY2002 FY2003 FY2004 FY2005 FY2006 FY2007 FY2008*

Mil

lio

ns

CAGR 32%

* Mid Point of 2008 Guidance issued December, 2007

Page 34: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Earnings Per Share Growth

$0.58

$0.94$0.85

$1.35

$2.32(E)*

$1.88

$0.75

$0.00

$0.50

$1.00

$1.50

$2.00

$2.50

FY2002 FY2003 FY2004 FY2005 FY2006 FY2007 FY2008

CAGR 26%

(E)

* Mid Point of 2008 Guidance issued December 2007

Page 35: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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

Q4 ’07 Q4 ’06 % Increase

Net Revenue 181 129 40%

Direct Costs 100 73 37%

SG & A 55 38 45%

D & A 5 4 37%_____ _____ _____

Operating Income 20 14 43%

Operating Margin 11% 10.7%

Net Income 16 11 40%_____ _____ _____

EPS (Inc SFAS123R) 53c 39c 36%

Weighted Average no. of Shares (Inc SFAS123R)

29.9m 29.1m 2.7%

Page 36: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Recent Financial Performance ($ millions)

FY2007 FY2006 % Increase

Net Revenue 631 456 38%

Direct Costs 355 256 38%

SG & A 188 137 38%

D & A 19 15 27%_____ _____ _____

Operating Income 69 48 45%

Operating Margin 11% 10.5%

Net Income 56 38 46%_____ _____ _____

EPS (Inc SFAS 123R) 188c 133c 41%

Weighted Average no. of Shares (Inc SFAS123R)

29.7m 28.7m 3.5%

Page 37: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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• 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

Margin improvement is a key focus.

Page 38: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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Summary Balance Sheet and Cash Flow ($ millions)

May 31, 05(Year)

Dec 31, 05(7 mths)

Dec 31, 06(Year)

Dec 31, 07 (Year)

Net Cash $78.4 $82.3 $98 $23.8

Total assets $347.6 $349.1 $476.3 $693.1

Shareholder’s equity $233.1 $241.6 $302.7 $388.4

Cashflow from operations

$23.8 $11.7 $51.5 $42.9

Capital expenditures $15.6 $12.1 $31.5 $75.4

CAPEX Excl. Dublin Extn. $15.6 $12.1 $20.4 $36.8

Shares outstanding 27.8 28.0 28.5 28.8

Page 39: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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• 85 bed clinical research unit in San Antonio, TX• Experienced team with excellent market reputation• Clinical pharmacology platform in the US to complement the UK CPU• Requires business development and commercial management support• Cost = $12m (Potential for further $10m if certain challenging targets met for ’08)• Revenues in ‘07 ≈ $8m • Profitable in H2 2007• Expected revenues of $10 - $12m in 2008• Earnings neutral 2008 (Earnout payment will not be triggered with this outcome)

Recent Phase I Acquisition In The US

Completed February 11th, 2008

Page 40: ICON Plc. 2008 Raymond James Institutional Investors Conference – March 4 th , 2008

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• Top Global Clinical CRO - #4• Outstanding record of growth • Strong market fundamentals • Excellent strategic position• Strong balance sheet• Margin expansion opportunity

Investment Case Summary