SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Private Issuer
Pursuant
to Rule 13a - 16 under
the
Securities Exchange Act of 1934
For
the
month of March 2007
ICON
plc
(Registrant’s
name)
0-29714
(Commission
file number)
South
County Business Park, Leopardstown, Dublin 18, Ireland.
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under
cover Form 20-F or Form 40-F.
|
Yes
X
|
No _____
|
Indicate
by check mark whether the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
|
Yes
_____
|
No
X
|
Indicate
by check mark whether
the registrant is submitting the Form 6-K in paper as permitted by Regulation
S-T Rule 101(b)(7):
|
Yes
_____
|
No
X
|
Indicate
by check mark whether the registrant by furnishing the information contained
in
this Form is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
|
Yes
_____
|
No
X
|
If
“Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):82 N/A
EXHIBIT
INDEX
|
Exhibit
Number |
Description
of Exhibit
|
|
99.1
|
Investor
Relations Presentation - March 2,
2007
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
Chairman
Dr.
John
Climax
ICON
Corporate
Dev
President
Bill
Taaffe
CEO
Peter
Gray
CFO
Ciaran
Murray
ICON
Development
Solutions
Solutions
President
Dr
Thomas
Frey
ICON
Central
Laboratories
President
Bob
Scott-Edwards
ICON
Contracting
Solutions
Solutions
Tony
Southers
Snr
VP
VP
Corporate
QA
Jo
Coyle
VP
Global
IT
Mike
McGrath
VP
Process
Development
Alan
Morgan
Exec.
VP
Organisational
Development
Development
Sean
Leech
VP
Strategic
HR
Eimear
Kenny
Group
Director
Market
Development
Development
Simon
Holmes
ICON
Clinical
EU
President
Dr
Peter
Sowood
ICON
Clinical
US
President
Dr
John
Hubbard
ICON
Clinical
ROW
President
Dr
Dan
Weng
ICON
Clinical
Research
Beacon
Bioscience
CEO
Ted
Gastineau
ICON
plc Global Organization
ICON
PLC
Investor
Relations Day 2007
Peter
Gray
March
2nd
2007
Chairman
Dr.
John
Climax
Dev
ICON
Corporate
President
Bill
Taaffe
CEO
Peter
Gray
CFO
Ciaran
Murray
ICON
Development
Solutions
Solutions
President
Dr
Thomas
Frey
ICON
Central
Laboratories
President
Bob
Scott-Edwards
ICON
Contracting
Solutions
Solutions
Tony
Southers
Snr
VP
VP
Corporate
QA
Jo
Coyle
VP
Global
IT
Mike
McGrath
VP
Process
Development
Alan
Morgan
Exec.
VP
Organisational
Development
Development
Sean
Leech
VP
Strategic
HR
Eimear
Kenny
Group
Director
Market
Development
Development
Simon
Holmes
ICON
Clinical
EU
President
Dr
Peter
Sowood
ICON
Clinical
US
President
Dr
John
Hubbard
ICON
Clinical
ROW
President
Dr
Dan
Weng
ICON
Clinical
Research
Beacon
Bioscience
CEO
Ted
Gastineau
ICON
plc Global Organization
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.
“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.
The
Journey So Far
The
Journey So Far
The
Journey So Far
The
Journey So Far
The
Journey So Far
The
Journey So Far
The
Journey So Far
The
Journey So Far
The
Journey So Far
The
Journey So Far
The
Journey So Far
The
Journey So Far
2006
•
Revenues
$450 million
•
Operating
Profits $47m
•
EPS
$1.33
•
Staff
4,300
1990
•
Revenues
$0.5 million
•
Operating
Profits $0m
•
Staff
5
The
Journey So Far
2007
Guidance
•
Revenues
$530-$550
•
Operating
Profits $58 - $62m
•
EPS
$1.63 -
$1.71
•
Staff
4,800
– 5,100
Market
Environment
*Source:
Tufts Centre for Study of Drug Development
Strong
Market Environment with...
•
Fundamental
R&D
Spending Growth Trend 6%- 8% p.a.
¯
Phase
II / III
pipelines strengthening
•
Increased
Outsourcing
¯
Being
accelerated by
activity & funding in Biotech / Speciality
¯
Globalisation
of
clinical research
¯
Cost
containment
pressures
¯
Evidence
that
projects, where CROs are engaged, complete faster than
“internal
only”
studies*
¯
Growth
c.15% p.a.
since 2001*
•
Increasing
Regulation
¯
More
patients/ more
studies
¯
Post
marketing
surveillance
Biotech
fund
raising ($billions)
Source:
Burrill and Company
…US
Biotech Funding continuing to grow,
leading
to...
Source:
Informa Health
…significant
growth in the number of
companies
with active clinical projects,….
Number
of
companies running clinical projects
Source:
FDA
Centre for Drug Evaluation & Research
(1)
Includes
active INDs for Therapeutic Biological Products Transferred from CBER
to CDER
effective 10/01/2003
(2)
Includes
INDs for Therapeutic Biological Products Transferred from CBER to
CDER
…
good recent growth in original IND
Applications,….
Source:
FDA
Number
of
Active INDs
…
which has lead to significant growth in the
number
of active INDs,…
49%
Increase
since 2000
Source:
IMS
R&D Focus, Dec 2006 and previous year SMRs
2002
–
2006
46% Growth Phase I – II
46% Growth Phase I – II
…which
is enriching pipelines generally,
and
leading to…
1)
Includes
the Therapeutic Biological Products Transferred from CBER to CDER effective
10/01/2003
Source:
FDA
Centre for Drug Evaluation & Research
….a
re-emergence of growth in NDA applications.
Not
a
“ Pig in a Python”, rather a …….
…bursting
dam….
…bursting
dam….
…bursting
dam.
ICON
Gross Business
Wins - Last 10 Quarters ($ millions)
Strong
business wins have led to…..
Net
Business
Wins
Book
to Bill
Ratio
…good
Net New Business Wins
and strong book-to-bill…
…leading
to record total backlog levels…
($
millions)
Value
of
backlog forecast to be earned in next 4 quarters
%
coverage
of next 4 quarters forecast revenues
…,
strong forecast coverage of next 4 quarters
revenues……..
Client
Concentration
2006 v 2005
…..and
a broadening of the customer base.
STRATEGY
2006
•
Revenues
$450 million
•
Operating
Profits $51m
•
Bookings
$665m
•
Staff
4,300
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Goal
2010
•
Revenues
$1bn
•
Of
which
acquisitions
contribute
$150m
•
Margins
≥14%
Core
Strategy is Organic Growth, with acquisitions
adding
new services or scale.
Chairman
Dr.
John
Climax
ICON
Corporate
Dev
President
Bill
Taaffe
CEO
Peter
Gray
CFO
Ciaran
Murray
Murray
ICON
Development
Solutions
Solutions
President
Dr
Thomas
Frey
Beacon
Bioscience
CEO
Ted
Gastineau
ICON
Central
Laboratories
President
Bo
Scott-Edwards
bICON
Contracting
Solutions
Solutions
Tony
Southers
Snr
VP
VP
Corporate
QA
Jo
Coyle
VP
Global
IT
Mike
McGrath
VP
Process
Development
Alan
Morgan
Exec.
VP
Organisational
Development
Development
Sean
Leech
VP
Strategic
HR
Eimear
Kenny
Group
Director
Market
Development
Development
Simon
Holmes
ICON
Clinical
EU
President
Dr
Peter
Sowood
ICON
Clinical
US
President
Dr
John
Hubbard
ICON
Clinical
ROW
President
Dr
Dan
Weng
ICON
Clinical
Research
ICON
plc Global Organization
Financial
Performance
|
Q4
’06
|
Q4
’PY
|
%
Increase
|
||
|
Net
Revenue
|
128.9
|
88.1
|
46.4%
|
|
|
Direct
Costs
|
72.5
|
48.7
|
48.8%
|
|
|
SG
&
A
|
37.6
|
26.8
|
40.3%
|
|
|
D
&
A
|
3.9
|
3.5
|
11.2%
|
|
|
_____
|
_____
|
_____
|
||
|
Operating
Income
|
14.9
|
9
|
65%
|
|
|
Net
Income
|
12.4
|
7
|
79%
|
|
|
_____
|
_____
|
_____
|
||
|
EPS
(ex
SFAS123R)
|
42c
|
24c
|
75%
|
|
|
EPS
(Inc
SFAS123R)
|
39c
|
|||
|
Weighted
Average no. of
Shares
(ex
SFAS123R)
|
29.7m
|
28.5m
|
Recent
Financial
Performance
($
millions, except
EPS)
|
FY
2006
|
FY
2005
|
%
Increase
|
||
|
Net
Revenue
|
456
|
342.8
|
32.9%
|
|
|
Direct
Costs
|
254
|
189.6
|
34%
|
|
|
SG
&
A
|
134.7
|
108.5
|
24.1%
|
|
|
D
&
A
|
14.9
|
13.9
|
7.4%
|
|
|
_____
|
_____
|
_____
|
||
|
Operating
Income
|
51.9
|
30.8
|
68.6%
|
|
|
Net
Income
|
42.4
|
24.3
|
74.3%
|
|
|
_____
|
_____
|
_____
|
||
|
EPS
(ex
SFAS123R)
|
145c
|
86c
|
68.6%
|
|
|
EPS
(Inc
SFAS123R)
|
133c
|
|||
|
Weighted
Average no. of Shares
|
29.3m
|
28.3m
|
Recent
Financial
Performance
($
millions, except
EPS)
Net
Revenue CAGR of 29% over 7 Years
Earnings
Per Share Growth
|
May
31,
05
(Year)
|
Dec
31, 05
(7
mths)
|
Dec
31,
06
(Year)
|
|
|
Net
Cash
|
$78.4
|
$82.3
|
$98
|
|
Total
assets
|
$347.6
|
$349.1
|
$476.3
|
|
Shareholder’s
equity
|
$233.1
|
$241.6
|
$302.7
|
|
Cashflow
from
operations
|
$23.8
|
$11.7
|
$51.5
|
|
Capital
expenditures
|
$15.6
|
$7.8
|
$12.3
|
|
Shares
outstanding
|
27.8
|
28.0
|
28.5
|
Summary
Balance Sheet and Cash Flow
($
millions)
*Source
SEC
Filings
Revenue
Growth v Peers: Net Revenue
CAGR
between 2000 and 2005
Investment
Highlights
•
Top
4 global
CRO
•
Strong
market
fundamentals
•
Outstanding
record
of organic growth
•
Strong
balance
sheet
•
Margin
expansion
opportunity
•
Good
strategic
position
Chairman
Dr.
John
Climax
ICON
Corporate
Dev
President
Bill
Taaffe
CEO
Peter
Gray
ICON
Development
Solutions
Solutions
President
Dr
Thomas
Frey
Beacon
Bioscience
CEO
Ted
Gastineau
ICON
Central
Laboratories
President
Bob
Scott-Edwards
ICON
Contracting
Solutions
Solutions
Tony
Southers
Snr
VP
VP
Corporate
QA
Jo
Coyle
VP
Global
IT
Mike
McGrath
VP
Process
Development
Alan
Morgan
Exec.
VP
Organisational
Development
Development
Sean
Leech
VP
Strategic
HR
Eimear
Kenny
Group
Director
Market
Development
Development
Simon
Holmes
ICON
Clinical
EU
President
Dr
Peter
Sowood
ICON
Clinical
US
President
Dr
John
Hubbard
ICON
Clinical
ROW
President
Dr
Dan
Weng
ICON
Clinical
Research
CFO
Ciaran
Murray
ICON
plc Global Organization
ICON
Clinical Research
Service
Overview
Services
•
ICON
Clinical Research is a global provider of outsourced Phase
II – IV
development
services
to the pharmaceutical, biotechnology and medical
device industries.
device industries.
•
Clinical
trial
management services include:
¯
Project
Management
¯
Clinical
Monitoring
¯
Data
Management
¯
Biostatistics
¯
Medical
Affairs,
Medical Writing & Safety Surveillance
¯
Late
Phase Services
(patient registries, health economics, outcomes
research)
¯
Interactive
Technologies (IVRS, ePRO, Portals, etc.)
ICON’s
Business Trends
In
Clinical
Research
1Excludes
IVR
only data
2Gross
= All
RFPs Received
3 Net
=
(Gross minus Cancelled, Declined, Non Award, Sent to Other
Division)
Clinical
Research 2003 – 2006 Annual (Gross vs. Net)
Global
RFP Flow
1Excludes
IVR
and Lab data
2Gross
= All
RFPs Received
3 Net
=
(Gross minus Cancelled, Declined, Non Award, Sent to Other
Division)
Clinical
Research 2003 - 2006 Annual (Gross vs. Net)
Global
RFP Value ($ Million)
by
Participating Region
1 Excludes
Change Order Values
1 Includes
IVR Values
2 Based
on Award Notification Date
3 Adjusted
Value not used as 2003-2005 data would not be
accurate
Award
Value in Millions
Global
Historical Awards by Originating Region
1 Excludes
Change Order Values
1 Includes
IVR Values
2 Based
on Award Notification Date
3 Adjusted
Value not used as 2003-2005 data would not be
accurate
Award
Value in Millions
Global
Historical Awards by Participating Region
Excludes
IVR Values
Award
Value in
Millions
Award
Values by Therapeutic Area Summary
Award
Value in Millions
Excludes
IVR
Values
Award
Value in Millions
Global/Regional
Award Values
Therapeutic
Area Summary - 2006
+
200%
Therapeutic
Growth (Awards)
Significant
growth in Oncology, CNS, Anti-infectives &
Endocrinology
2003
2006
Therapeutic
Growth (%Revenues)
Composition
of Business
(Phase
II-IV only) (% of Revenue)
Increased
Outsourcing of Full Service Work
(U.S.
Business)
Total
Number of Active Projects by Region
Increasing
Contribution by EU and ROW
to
ICON’s Business growth….
Active
Projects & Therapeutic Mix by Region
(%
of
Backlog for 2007)
Concluding
Remarks
ICON
is well Positioned to…….
•
Capitalise
on the
expanding market in late phase and safety studies
•
Increase
geographical “foot print” to enhance patient recruitment for
global
studies
•
Shift
backend
support to low cost regions such as India
•
Utilize
technology
to improve efficiency and enhance value (ICOPhone,
ePRO,
EDC,
ICOnet)
•
Achieve
excellence
in key therapeutic areas and global project
management
Chairman
Dr.
John
Climax
ICON
Corporate
Dev
President
Bill
Taaffe
CEO
Peter
Gray
CFO
Ciaran
Murray
ICON
Development
Solutions
Solutions
President
Dr
Thomas
Frey
Beacon
Bioscience
CEO
Ted
Gastineau
ICON
Central
Laboratories
President
Bob
Scott-Edwards
ICON
Contracting
Solutions
Solutions
Tony
Southers
Snr
VP
VP
Corporate
QA
Jo
Coyle
VP
Global
IT
Mike
McGrath
VP
Process
Development
Alan
Morgan
Exec.
VP
Organisational
Development
Development
Sean
Leech
VP
Strategic
HR
Eimear
Kenny
Group
Director
Market
Development
Development
Simon
Holmes
ICON
Clinical
EU
President
Dr
Peter
Sowood
ICON
Clinical
US
President
Dr
John
Hubbard
ICON
Clinical
ROW
President
Dr
Dan
Weng
ICON
Clinical
Research
ICON
Clinical
US
COO
Malcolm
Burgess
ICON
plc Global Organization
•
Electronic
Data
Capture (EDC) has been around almost
30
years
•
Adoption
has been
slower than the technologists
predicted
•
So
what’s
changed
EDC
–
Origins of the species
ICON’s
evaluation and selection of vendors
•
Historical
experience with 14 different systems
¯
Driven
by state of
the market and client variation (no clear leader)
¯
Breath
of experience
beyond the reach of Pharma
•
Evaluated
top 15
systems during 2004
¯
Functionality
(Investigator, Monitor & Data Manager)
¯
Scalability
&
Financial stability
¯
Cost
comparison
•
Selected
Medidata
Rave™ (February 2005)
¯
Non-exclusive
agreement
•
Rave™ well
accepted but clients continue to mandate other systems
•
Added
Phase Forward
Inform™ (January 2007)
¯
Rave™ and
Inform™ dominated 2006 sales (each about 40% of market)
¯
Allows
us to cover
the majority of our EDC committed client base
•
So
why
Rave™ & Inform™ (and not other suppliers)
¯
Ease
of use
(Investigator, Monitor and Data Management)
¯
Internet
enabled
with zero footprint at site (minimal support overhead)
¯
Established
relationships with ICON & positive real life experiences
¯
Limit
to speed of
technology transfer & number of systems
¯
Continue
to review
other niche providers (eg Late Phase)
Adoption
metrics
•
In
the last 3
years
¯
ICON
has won 6 times
as many EDC projects than in the preceding
13
years
¯
EDC
Wins have more
than doubled year on year
•
8
wins in 2004, 17
wins in 2005 and 38 wins in 2006
¯
Requests
for
proposals featuring EDC comprised about 35% of
our
portfolio at the
end of 2006 (<1% in 2003)
¯
Currently
over 20%
of our projects are using EDC, this is projected
to
reach between 35
and 40% by the end of 2007
•
Current
EDC project
portfolio
¯
53
ongoing EDC
studies (plus 25 completed studies)
•
31
studies in
Medidata Rave™
•
Over
2,000
sites and 20,000 patients
•
11
studies using
Phase Forward Inform™
•
Over
450
sites and 5,000 patients
•
11
studies using
other EDC systems (client mandated)
Supports
complex
studies
(eg
Oncology)
Oncology)
Faster
time to
database
lock and
final study reports
final study reports
Access
to
data
(Adaptive
trials)
>$6M
Drivers
for adoption – cost, speed & visibility
ICON
Investor
Relations Day 2007
Short
Break
Chairman
Dr.
John
Climax
ICON
Corporate
Dev
President
Bill
Taaffe
CEO
Peter
Gray
CFO
Ciaran
Murray
ICON
Development
Solutions
Solutions
President
Dr
Thomas
Frey
Beacon
Bioscience
CEO
Ted
Gastineau
ICON
Central
Laboratories
President
Bo
Scott-Edwards
bICON
Contracting
Solutions
Solutions
Tony
Southers
Snr
VP
VP
Corporate
QA
Jo
Coyle
VP
Global
IT
Mike
McGrath
VP
Process
Development
Alan
Morgan
Exec.
VP
Organisational
Development
Development
Sean
Leech
VP
Strategic
HR
Eimear
Kenny
Group
Director
Market
Development
Development
Simon
Holmes
ICON
Clinical
EU
President
Dr
Peter
Sowood
ICON
Clinical
US
President
Dr
John
Hubbard
ICON
Clinical
ROW
President
Dr
Dan
Weng
ICON
Clinical
Research
ICON
plc Global Organization
IMPROVE
•
Root
and branch
review of Standard Operating Procedures to enhance
consistency
of
client experience and efficiency of operational delivery
¯
Data
Management
¯
Site
visits
¯
Document
Management
& Archiving
¯
Regulatory
&
Ethics submissions
¯
Site
selection &
feasibility
EXPEDITE
•
A
review of project
management methodology, procedures, and tools,
to
enhance
consistency of client experience and effectiveness of
operational delivery
operational delivery
¯
Consistent
work
break down structure across systems
¯
Templates
to assist
in task planning
¯
More
structured
approach to risk management
¯
Standardised
global
training for project leaders
¯
Creation
of a global
Project Management Office
New
Investments in tools
•
Continuous
investment in new tools to support new processes and to
provide
a scaleable
system framework for the enterprise
¯
Clinical
Trial
management system ( ICOTrial ) active on over 70 projects
¯
SOPs
management
systems launched at the end of 2006 (iDoc )
¯
Sales
contact
management tool launched in January 2007 (salesforce.com)
¯
New
training and
compliance system currently being launched (iLearn )
¯
New
enterprise wide
financial and project accounting system will go live in Q3
2007
Supporting
Growth – Systems, Process, and QA
Chairman
Dr.
John
Climax
ICON
Corporate
Dev
President
Bill
Taaffe
CEO
Peter
Gray
CFO
Ciaran
Murray
ICON
Development
Solutions
Solutions
President
Dr
Thomas
Frey
Beacon
Bioscience
CEO
Ted
Gastineau
ICON
Central
Laboratories
President
Bob
Scott-Edwards
ICON
Contracting
Solutions
Solutions
Tony
Southers
Snr
VP
VP
Corporate
QA
Jo
Coyle
VP
Global
IT
Mike
McGrath
VP
Process
Development
Alan
Morgan
Exec.
VP
Organisational
Development
Development
Sean
Leech
VP
Strategic
HR
Eimear
Kenny
Group
Director
Market
Development
Development
Simon
Holmes
ICON
Clinical
EU
President
Dr
Peter
Sowood
ICON
Clinical
US
President
Dr
John
Hubbard
ICON
Clinical
ROW
President
Dr
Dan
Weng
ICON
Clinical
Research
ICON
plc Global Organization
JPMA
–
Japan
Dec
2006
Total
R&D Spend of Japanese Pharmaceutical
Companies
JCROA-Japan,
Dec
2006
The
Revenue of CROs in Japan
|
Clinical
Staff
|
Location
|
|
|
ICON
|
70
|
Tokyo
|
|
Quintiles
|
300
|
10
offices in
Japan
|
|
CMIC
|
350
|
10
offices in
Japan
|
|
EPS
|
300
|
10
offices in
Japan
|
|
MSP
|
150
|
3-4
offices in
Japan
|
|
Parexel
|
250
|
Kobe/Tokyo
|
CROs
in Japan (as of 2006)
CRO
Opportunities in Japan
•
Domestic
growth
¯
Increasing
Demands
•
Headcount
cut in
pharma Vs more clinical trials
•
Pivotal
studies Vs
local studies
•
Mega
companies (big
three) Vs middle/small pharmas
•
CRO
growth Vs SMO
involvement (less SMO needs)
•
SMO
currently acts as a ‘patient broker’
•
Regional
study
management
¯
Joint
studies
between Japan and region
•
Unique
processes,
culture difference, language, ICON’s presence in the
region
•
Current
modification
on Japanese Regulations (Asia data to support
Japanese
NDA)
Clinical
Research in India – Medium term opportunity
•
Progressively
developing infrastructure ( >14000 hospitals by 2010)
•
Cost
effectiveness
-50% of the cost in US
•
Large
Population
¯
Genetically
heterogeneous
¯
Treatment
Naive
Patient population
¯
Expedited
target
recruitment
•
Indications
¯
Prevalence
of rare
diseases
¯
Huge
patient
population of diseases like Diabetes and
Tuberculosis
•
Compliance
to global
quality and ethical standards
•
Availability
of
highly skilled medical professionals and research staff
•
Large
pool of
English speaking Caucasian population
•
Streamlined
regulatory structure
Amritsar
Geographical
spread of current ICON
managed
sites
Clinical
Research in China – Longer term opportunity
•
Top
investigators-5-10 years global experience
•
Patient
pool/
Recruitment reliability (216 hospitals,53
different
specialties for GCP certified clinical trials
centers)
centers)
•
Rapidly
expanding
pharmaceutical market ---5th
largest
by 2010,
2nd/3rd largest
by
2020
•
Huge
CRO market
potential
•
Cost-competitive
:
40% reduction Vs EU & USA
•
Global
trials
accelerated China marketing registration
•
More
clinical trials
for domestic NDAs
•
Long
timeline for
CTA approval
Chairman
Dr.
John
Climax
ICON
Corporate
Dev
President
Bill
Taaffe
CEO
Peter
Gray
CFO
Ciaran
Murray
ICON
Developme
nt Solutions
nt Solutions
President
Dr
Thomas
Frey
Beacon
Bioscience
CEO
Ted
Gastineau
ICON
Central
Laboratories
President
Bob
Scott-Edwards
ICON
Contracting
Solutions
Solutions
Tony
Southers
Snr
VP
VP
Corporate
QA
Jo
Coyle
VP
Global
IT
Mike
McGrath
VP
Process
Development
Alan
Morgan
Exec.
VP
Organisational
Development
Development
Sean
Leech
VP
Strategic
HR
Eimear
Kenny
Group
Director
Market
Development
Development
Simon
Holmes
ICON
Clinical
EU
President
Dr
Peter
Sowood
ICON
Clinical
US
President
Dr
John
Hubbard
ICON
Clinical
ROW
President
Dr
Dan
Weng
ICON
Clinical
Research
ICON
plc Global Organization
ICON
Development Solutions
•
Medeval:
Full
Service Clinical Pharmacology Unit, Manchester, UK
•
GloboMax:
Strategic
Product Development Consulting, Baltimore, US
•
ICON
Consulting
(YRCR): Regulatory Affairs Consulting, Early Phase Clinical
Operations,
Marlow,
UK
ICON
Development Solutions
•
Regulatory
and
Development Strategy
•
Protocol
Design
•
Regulatory
Submissions and Agency Meetings
•
Study/Program
Execution
•
Evaluation
and
Reporting
Ø
From
compound
selection through development to approval
and
beyond
Service
Proposition
|
Area
|
Collective
Expertise
|
|
Clinical
Drug
Development / Clinical
Pharmacology
|
>12
MDs/PhD
>130 years experience,
>1200
ph
I/IIA trials
|
|
Regulatory
Affairs
|
15
MSc/PhD
>150 years
EU/US
experience
|
|
CMC,
Formulation Development
|
>6
MSc/PhD
>100 years experience
|
|
PK/PD,
Pharmacometrics
|
14
MSc/PhD,
over 100 years
experience
|
Scientific
Capability
|
Area
|
Activity
|
|
Development
Consulting
|
Build
on US
strengths and expand in
EU
|
|
Regulatory,
Publishing
|
E-submission
requirement in EU/US
creates
big
growth opportunity
|
|
Phase
I
|
US
Phase I
acquisition
Expansion
into
special population
studies
|
|
PK,
PD,
Pharmacometrics
|
Constant
demand for services,
modeling
and
simulation rising
|
|
CMC,
Non-clinical
|
Life
cycle
management segment
growing
|
Strategy
For Growth
Chairman
Dr.
John
Climax
ICON
Corporate
Dev
President
Bill
Taaffe
CEO
Peter
Gray
CFO
Ciaran
Murray
ICON
Development
Solutions
Solutions
President
Dr
Thomas
Frey
Beacon
Bioscience
CEO
Dr
Ted
Gastineau
ICON
Central
Laboratories
President
Bob
Scott-Edwards
ICON
Contracting
Solutions
Solutions
Tony
Southers
Snr
VP
VP
Corporate
QA
Jo
Coyle
VP
Global
IT
Mike
McGrath
VP
Process
Development
Alan
Morgan
Exec.
VP
Organisational
Development
Development
Sean
Leech
VP
Strategic
HR
Eimear
Kenny
Group
Director
Market
Development
Development
Simon
Holmes
ICON
Clinical
EU
President
Dr
Peter
Sowood
ICON
Clinical
US
President
Dr
John
Hubbard
ICON
Clinical
ROW
President
Dr
Dan
Weng
ICON
Clinical
Research
ICON
plc Global Organization
Central
Laboratory – 2006 Overview
•
Revenue
grew by
+65%
¯
Europe:
+93%USA:+62%
•
Won
289 New
studies
¯
Strike
rate:47%
¯
Repeat
business:88%(31 New Clients)
•
Backlog:~$100m(+26%)
•
Customer
Satisfaction:
¯
94%
would use us
again
¯
94%
would recommend
us to colleagues
¯
54%
thought we were
the “best” Central Laboratory
¯
33%
thought we were
as good as the “others”
•
Headcount
grew to
356
Central
Laboratory – 2007 Outlook
•
Target
Revenue
growth:>20%
•
Target
margin:8-10%
at year end
•
Expanding
Sales
Team
•
Organization
growth
tailored to demand
•
Expanded
use of Six
Sigma and Metrics
•
Continue
to expand
test menu/platforms
¯
Focus
on Flow
Cytometry and key biomarkers
Central
Laboratory – 2007 Outlook
•
Kit
output:
¯
~45,000
kits/month
compared to ~25,000 in 2005
•
Upgrading
systems
& processes to yield further
efficiencies
¯
Kit
automation
initiative underway
¯
Upgrade
to IT
systems underway
¯
Launched
new RDA
system
•
Dublin
has expanded
– Laboratory & Support Teams
¯
Will
continue as new
HQ comes on line
•
Singapore
is on
line
¯
Sample
receipt/Reporting
•
Actively
seeking
partners in India & China
200,000
250,000
300,000
350,000
400,000
450,000
500,000
550,000
Jan-06
Feb-06
Mar-06
Apr-06
May-06
Jun-06
Jul-06
Aug-06
Sep-06
Oct-06
Nov-06
Dec-06
Total
Kits
Total
Accessions
Kits
& Accessions - 2006
Challenges…
•
Extending
our Global
presence…
¯
Singapore,
India,
China…
¯
Upgrading
our
Affiliate activity…
•
Adding
high caliber
staff
•
Retaining
our
distinctive style -
¯
A
service business
built around a Lab
¯
Producing
high
quality data
¯
Noted
for
Responsiveness and Flexibility
¯
Focused
on Customer
Delight!
•
Keeping
focused:
¯
Efficiency
&
Effectiveness with High Quality!
Chairman
Dr.
John
Climax
ICON
Corporate
Dev
President
Bill
Taaffe
CEO
Peter
Gray
CFO
Ciaran
Murray
ICON
Development
Solutions
Solutions
President
Dr
Thomas
Frey
Beacon
Bioscience
CEO
Ted
Gastineau
ICON
Central
Laboratories
President
Bob
Scott-Edwards
ICON
Contracting
Solutions
Solutions
Tony
Southers
Snr
VP
VP
Corporate
QA
Jo
Coyle
VP
Global
IT
Mike
McGrath
VP
Process
Development
Alan
Morgan
Exec.
VP
Organisational
Development
Development
Sean
Leech
VP
Strategic
HR
Eimear
Kenny
Group
Director
Market
Development
Development
Simon
Holmes
ICON
Clinical
EU
President
Dr
Peter
Sowood
ICON
Clinical
US
President
Dr
John
Hubbard
ICON
Clinical
ROW
President
Dr
Dan
Weng
ICON
Clinical
Research
ICON
plc Global Organization
What
we do
Beacon
provides a
Complete Solution for medical
imaging
based
product development.
A
Complete Solution
•
Design Clinical
Trial
Design focused
on
imaging. Regulatory
________________________________________________________________
•
Implement the
imaging at
hospitals
_________________________________________________________________
•
Manage all
digital images
centrally from
radiology department
_________________________________________________________________
•
Analyze
Provide
centralized analysis of images
quantitative,
qualitative
_________________________________________________________________
•
Deliver
Develops
comprehensive digital
databases for Sponsor and Agency
We
think differently
•
Imaging
sees/measures
structure
and
function
•
Each
pixel
represents a
physiologic/metabolic
characteristic.
characteristic.
•
Images
are
spatially
distributed
data
Information
is a Verb
“Information:
verb
active
information derived from passive
data
using a new
level of information
analysis.”
analysis.”
-Michael
Dertouzous, M.I.T. 1998
2005
2006
Therapeutic
Growth (%Revenues)
Medical
Imaging – 2005 and 2006
Global
RFP Value ($ Million)
New
Awards and Backlog
Revenue
and Margin
Re-branding
Beacon Bioscience to
ICON
Medical Imaging
•
Beacon
Bioscience
will be re-branded to become
ICON
Medical
Imaging
•
This
reflects our
further integration and our status as a
core
division of
ICON
•
We
are launching a
year long campaign including
mailers,
meetings,
and trade shows
•
Excellent
opportunity to re-tell our growth story,
emphasize
our size
and differentiate the value
proposal
proposal
Chairman
Dr.
John
Climax
ICON
Corporate
Dev
President
Bill
Taaffe
CEO
Peter
Gray
CFO
Ciaran
Murray
ICON
Development
Solutions
Solutions
President
Dr
Thomas
Frey
Beacon
Bioscience
CEO
Ted
Gastineau
ICON
Central
Laboratories
President
Bob
Scott-Edwards
ICON
Contracting
Solutions
Solutions
Tony
Southers
Snr
VP
VP
Corporate
QA
Jo
Coyle
VP
Global
IT
Mike
McGrath
VP
Process
Development
Alan
Morgan
Exec.
VP
Organisational
Development
Development
Sean
Leech
VP
Strategic
HR
Eimear
Kenny
Group
Director
Market
Development
Development
Simon
Holmes
ICON
Clinical
EU
President
Dr
Peter
Sowood
ICON
Clinical
US
President
Dr
John
Hubbard
ICON
Clinical
ROW
President
Dr
Dan
Weng
ICON
Clinical
Research
ICON
plc Global Organization
BPA
/ MCS Acquisition October 2002
•
Two
business
segments BPA and MCS
•
BPA
¯
Clinical
Division with good Transplant,
Oncology
and Vaccine
experience
¯
BPA
integrated into the US clinical division
•
MCS
–
¯
Focused
on
contract staffing
¯
New
service
for ICON
¯
Stand
alone
status
BPA
– Post Acquisition
•
BPA
was
integrated into ICON and many of the
personnel
are still
with ICON 4 years on
•
Added
to the
overall value of ICON
¯
Critical
mass when required and
¯
Therapeutic
expertise and experience
Success !!!!!!
June
2005
•
Tony
Southers (Ex VP of BD-Europe) appointed Head
of
MCS
¯
Introduced
a
Sales Team and a Client ‘Service’
focus
¯
Improved
/
Updated processes & technology
¯
Upgraded
candidate package
¯
Developed
growth strategy
¯
Re-aligned
the group into ICON and improved
operational
leverage
¯
Change
of
name
MCS
Re-launch
Plan
ICS
Revenue History
ICS
Future Growth Opportunities
•
Growth
within the US will continue
¯
35%
growth
next year (current NY location)
¯
Expand
permanent placement capabilities
¯
West
Coast
market exploration (build or buy)
•
Other
opportunities within new markets
¯
Europe
(build or buy)
¯
Advantage
of
offering global coverage
¯
Same
clients
within US and EU
•
Further
opportunities beyond EU would include the new
emerging
markets
¯
South
America & Asia
ICON
PLC
Q&A
Session