icon plc. 2008 raymond james institutional investors conference – march 4 th , 2008
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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 PresentationTRANSCRIPT
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ICON Plc.2008 Raymond James Institutional Investors Conference – March 4th, 2008
Mr. Peter Gray - CEO
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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
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Global Full Service Clinical Development
US 53%
EU 38%
ROW 9%
Q4 Revenue by Region
GlobalClinical
4
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
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Market Environment
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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
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7
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
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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
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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%
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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
$Bil
lio
n
Biotech fundraising (excluding debt financing)
Source: Burrill and Company
US Biotech Funding Environment continued to grow
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ICON in this Market Environment
1212
RFP Value by Market Segment
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
2003 2004 2005 2006 2007 2008 2009 2010
(in m
illio
ns)
Total Large Pharma MidSize Pharma Biotech
2007 Value
54% Increase / PY
Size of Projects
41 > 20 Million
168 > 5 Million
959 < 5 Million
Gross RFP Value by Market Segment
(Including RFPs that never progress to award)
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Strong RFP volume growth, with increasing average proposal value…
Number of Proposals
571
8871014
1118
400
600
800
1000
1200
2004 2005 2006 2007
Average Proposal Size ($ millions)
2.8 3.1 3.6
5.4
0
2
4
6
2004 2005 2006 2007
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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
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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)
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.. excellent Net New Business wins and very strong book to bill ratios…
$140
$171$166
$157$171
$223 $230
$344
$230
Q4 05 Q1 06 Q2 06 Q3 06 Q4 06 Q1 07 Q2 07 Q3 07 Q4 07
1.6
1.3
1.6 1.6
1.9
1.3 1.41.6
1.7
Net Business Wins Book to Bill Ratio
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…leading to record Total Backlog levels. ($ 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
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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
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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
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….and broad therapeutic expertise.
Revenue by Therapeutic Area 2007
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Quality
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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%)
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…but Quality and Delivery remains our Key Focus.
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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)
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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,….
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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,….
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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,….
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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
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Strategy
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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%
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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
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Financial Performance
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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
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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
$2.50
FY2002 FY2003 FY2004 FY2005 FY2006 FY2007 FY2008
CAGR 26%
(E)
* Mid Point of 2008 Guidance issued December 2007
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Recent Financial Performance ($ 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%
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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%
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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”
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Margin improvement is a key focus.
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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
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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
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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