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JP Morgan Healthcare Conference January 13, 2009 Angus Russell, CEO Shire plc

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Page 1: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

JP Morgan Healthcare ConferenceJanuary 13, 2009

Angus Russell, CEOShire plc

Page 2: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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.

Page 3: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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Shire Purpose Statement

We enable people with life-altering conditions to

lead better lives.

Page 4: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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.

Page 5: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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

Page 6: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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)

Page 7: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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%

Page 8: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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

Page 9: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%
Page 10: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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%

Page 11: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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

Page 12: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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

Page 13: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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

Page 14: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%
Page 15: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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

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Page 17: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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%

Page 18: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%
Page 19: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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

Page 20: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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)

Page 21: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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

Page 22: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

Questions and Answers

Georgian Room

Page 23: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

APPENDIX

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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

Page 25: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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.

Page 26: Angus Russell, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/... · 1/13/2009  · 19 FIRAZYR Launched by Jerini in Germany, Austria and the UK Shire now has over 98%

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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