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JP Morgan Healthcare ConferenceJanuary 13, 2009
Angus Russell, CEOShire plc
2
THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE™ (lisdexamfetamine dimesylate) (Attention Deficit Hyperactivity Disorder (“ADHD”)); the impact of competitive products, including, but not limited to, the impact of those on the Company’s ADHD franchise; patents, including but not limited to, legal challenges relating to the Company’s ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV™ (guanfacine extended release) (ADHD); the Company’s ability to secure new products for commercialization and/or development; the Company’s ability to successfully integrate Jerini AG, as well as realize the anticipated benefits of the acquisition; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2007.
3
Shire Purpose Statement
We enable people with life-altering conditions to
lead better lives.
4
Our Purpose: We enable people with life-altering conditions to lead better lives.
OUR MISSION STATEMENTBy 2015, Shire aspires to be the most valuable specialty biopharmaceutical company in the world.
To achieve these results Shire aims to:
Deliver leading peer group financial performance.
Attain the #1 or #2 position in each of our chosen therapeutic areas, as measured byglobal market share.
Grow sales in the mid-teens range year-on-year on average over the course of 2009through 2015.
Have 50% of sales come from outside of the USA and 25% of sales be from outside of the USA, Germany, Italy, Spain, UK, France and Canada.
We will achieve our goals by nurturing and strengthening our brave and collaborative culture, which differentiates us from “Big Pharma” and allows all our people to impact and shape our business.
We will encourage trust and openness in tackling business challenges. We will avoid complacency and foster innovation by taking measured risks, actively experimenting, learning from both success and failure and moving opportunistically into areas that grow our business.
5
Our Strategy Principles:
Specialist focus; symptomatic diseases; high unmet needs; niche markets
Remain agile, move fast and jump on opportunities that present themselves
Focus on our best opportunities and be prepared to exit underperforming or low priority assets and businesses
Strong bias towards outsourcing non-differentiating capabilities
Strong bias towards projects and technologies that have proof of concept in man, are low risk and allow for a quick development decision point
Need to diversify business concentration through addition of bolt on products and corner lots and through international expansion
Our purpose and mission are supported by a set of underlying strategy principles
6
Potential launches from 2009-2015*
201120102009 2012-2015
DAYTRANA ADOLESCENT
VELAGLUCER-ASE ALFA
PLICERA
AMIGAL
HGT 3510(Pompe)
ELAPRASE IT
SANFILIPPO ERT
AVOTERMIN
LIALDA DIVERTICULITIS
SPD550 (Celiac)
WOMEN’S HEALTH PORTFOLIO
FOSRENOL –CKD
DAYTRANA EU
INTUNIV**
*Subject to regulatory approvals**Approvable letter received
VYVANSE EU
HGT 1111 (METAZYM)
7
Product Sales by Business Unit
2008
ADHD, 53%
HGT, 18%
GI, 13%Other, 16%
0%
10%
20%
30%
40%
50%
60%
2015
ADHD, 35%HGT, 30%
GI, 25%
Other, 10%
0%
10%
20%
30%
40%
50%
60%
8
Spec Pharma HGT Total Spec Pharma HGT TotalTotal sales % 85% 15% 100% 70% 30% 100%
Gross Margin 85% 89% 86% 86% 87% 86%
R&D (14%) (47%) (19%) (14%) (25%) (17%)
S&M (37%) (19%) (35%) (31%) (16%) (26%)
G&A - - (11%) - - (9%)
EBITDA Margin 34% 23% 21% 41% 46% 34%
2007 TARGET
Note: All expense ratios are a percentage of product sales
Long Term Target Financial Ratios
10Source: IMS NPA Weekly
0%
2%
4%
6%
8%
10%
12%
6/22 7/67/20 8/38/17
8/31
9/14
9/28
10/12
10/2611
/911
/2312/7
12/21 1/41/1
8 2/12/15
2/29
3/14
3/28
4/11
4/25 5/95/23 6/66/20 7/47/18 8/18/15
8/29
9/12
9/26
10/10
10/2411
/711
/2112/5
12/19
TRx
Sha
re
Labor Day
Christmas/New Years
Thanksgiving
Labor Day
Memorial Day4th of July
10.7%
Thanksgiving
Approximately 4 million VYVANSE TRx have been filled
Approximately 1 Million individual patients have been prescribed VYVANSE
Christmas
VYVANSE Market Share Continues to Grow and has now surpassed 10%
11Source: IMS Xponent and NPA data ending October 2008
0.0%
2.0%
4.0%
6.0%
8.0%
10.0%
12.0%
14.0%
16.0%
JunJulAugSeptOctNovDecJanFebMarAprMayJuneJulyAugustSeptemberOctober
Top 14,000 Top 43,000 National Share
13.5%
15.0%
10.1%
High Volume ADHD Treaters Are Adopting VYVANSE, and Trickle Down Is Occurring With Lower Level prescribers
12
3.0%3.5%4.0%4.5%5.0%5.5%6.0%6.5%7.0%7.5%
Jan-08 Feb Mar Apr May Jun
eJul
yAug Sep
tOct Nov
ADHD Adult Market Share (Ages 18+)
Source: SDI Vector One: National
FDA Approval of Adult ADHD
Adult launch
VYVANSE share of adult patients is increasing
13*Source: Age Specific - SDI Vector One National; Overall - IMS
3.5% 3.6%
15.8%
0%2%4%6%8%
10%12%14%16%
ChildrenAdolescentsAdults
*Year To Date Market Growth – November 2008
Year to date market growth per IMS: +6.6%
The ADHD market continues to grow driven by the adult segment
15Source: IMS NPA Monthly
Oral 5-ASA Market Definition: Lialda, Pentasa, Asacol, Colazal and Dipentum
Total Shire US GI monthly share reached 30.5% of Oral 5-ASA Market
Shire GI Portfolio Oral 5-ASA Monthly TRx Share
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
Feb-07
Mar-07
Apr-07
May-07
Jun-0
7Ju
l-07
Aug-07
Sep-07
Oct-07
Nov-07
Dec-07
Jan-08
Feb-08
Mar-08
Apr-08
May-08
Jun-0
8Ju
l-08
Aug-08
Sep-08
Oct-08
Nov-08
Pentasa Lialda GIBU Portfolio
17
ELAPRASE Highly Penetrated -Growth Potential Remains
ELAPRASE regional patient penetration
Western EU North America APAC Latin America0%
10%
20%
30%
40%
50%
60%
70%
80%
% P
enet
ratio
n
75% 72%
51%
43%
19
FIRAZYR
Launched by Jerini in Germany, Austria and the UK
Shire now has over 98% of Jerini’s shareholding and has initiated squeeze out of minority shareholders
First pan-European product approved for acute attacks of hereditary angioedema
First-in-class HAE therapy available for subcutaneous administration in a convenient, pre-filled syringe which can be transported and stored at room temperature
US entry requirement
Placebo-controlled trial to be initiated in 2009
20
Duration of Patent and Regulatory Exclusivity
^ Currently difficult generic approval pathway for locally acting drugs*Orphan Drug** Regulatory Exclusivity in EU until 2017# Assuming US approval
2000 2005 2010 2015 2020 2025
20232012
2013**2019ELAPRASE*
(500-600)
20182009
FOSRENOL(300-400)
20202010LIALDA^
(400-500)
VYVANSE(1,500 – 2,000)
Patent Term Regulatory Exclusivity
20202011REPLAGAL EU*
(300-350)
FIRAZYR EU*(350-400)#
20182009
(Peak sales range $m)
21
SOLID PLATFORM FOR FUTURE GROWTH
Strong financial performance
New product portfolio representing 39% of Q3 product sales and exceeding ADDERALL XR sales for the first time
VYVANSE well positioned for continued growth
Launch of FIRAZYR brings a new addition to the portfolio of specialist treatments for rare diseases
Robust pipeline with focus on orphan drugs and specialist products treating symptomatic disorders
8 products acquired since beginning of 2007
Strong portfolio of high growth products with long patent protection and regulatory exclusivity
Questions and Answers
Georgian Room
APPENDIX
24
2009 Non GAAP EPS-ADS GuidanceEPS-ADS PLANNING RANGE
AT 2008 FOREX (1)
Aggressive XR erosion curve Scheduled drug XR erosion curve
Multiple generics from 1 Oct
FOREX FLEXEDEPS-ADS RANGE
$3.00 $3.40
Continued growth in new products(2)
Aggressive cost base management
2008 YTD €1 : $1.52 £1 : $1.95
Flex rate €1 : $1.35 £1 : $1.70EPS-ADS impact : -$0.20 per ADS
Only 2 authorised generics as of 1 Oct
$2.80 $3.20
Continued investment in future growth drivers
Notes(1)
Forex rates €/$ £/$ EPS-ADS Sensitivity €/$ £/$2009 Flex rate 1.35 1.70 10c fall in rate -$0.10 -$0.012008 YTD 1.52 1.95Difference -0.17 -0.25 -$0.20 = (17c/10c x -$0.10) + (25c/10c x -$0.01)
(2) New products are Daytrana, Fosrenol, Elaprase, Firazyr, Intuniv, Lialda/Mezavant and Vyvanse(3) EPS-ADS Guidance provided on a one off basis.
Guidance is based off the following forex rates. The sensitivity of earnings to movements in rates is shown below
25
2008 Guidance
All guidance for 2008 is reiterated other than:VYVANSE:
Previous guidance: lower end of $350m to $400m
Current guidance: In the range of current published analyst estimates of $310m to $330m
Acquisition of Jerini AGGuidance now includes costs associated with FIRAZYR
Revenues and costs associated with the Ophthalmic and Peptide businesses have been classified as operations held for sale (buyers are being sought)
In-process R&D ($121m) and integration and transaction related costs ($8m) have been excluded in calculating Non GAAP earnings.
26
Latest 2008 Non GAAP Guidance (1)
(1) Non GAAP net income for 2008 includes FAS123R and excludes: amortisation, gains and losses on the sale of non-core assets, other than temporary impairments of investments, IPR&D, integration and transaction costs relating to the Jerini acquisition, results from discontinued operations, upfront payments and milestones in respect of in-licensed and acquired products including the payment to Zymenex for Metazym, charges associated with the DYNEPO exit, new holding company set up costs and taxes associated with these items.
~ 23%Non GAAP Tax Rate
~ $75mDepreciation ($m)
$300- $330mCapex
$1,125 - $1,165mSG&A
~ $500mR&D
In the range of current published analyst estimates of $310m to $330mVYVANSE Product Sales
At least 20 %Revenue growth
Guidance