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Merrill Lynch conference Matthew Emmens, CEO Shire plc September 20, 2007

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Page 1: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

Merrill Lynch conference

Matthew Emmens, CEOShire plcSeptember 20, 2007

Page 2: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

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, Shire’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; the impact of competitive products, including, but not limited to the impact of those on Shire’s Attention Deficit and Hyperactivity Disorder (“ADHD”) franchise; patents, including but not limited to, legal challenges relating to Shire’s ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV™ (guanfacine) extended release (ADHD); Shire’s ability to secure new products for commercialization and/or development; Shire’s ability to benefit from its acquisition of New River Pharmaceuticals Inc.; the successful development of JUVISTA® (human TGFβ3) and other risks and uncertainties detailed from time to time in Shire plc’s filings with the Securities and Exchange Commission, particularly Shire plc’s Annual Report on Form 10-K for the year ended December 31, 2006.

Page 3: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

3

Introduction

Continue to execute on strategy effectively

Excellent half year results

Revenue growth accelerating with new product launches - (up 30% for H1 2007 on previous year)

Upgrading revenue growth guidance to at least 25% (previous guidance low 20% range)

VYVANSE Launch – rapid uptake

Good progress in strengthening our R&D pipeline

Page 4: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

4

Q2 Financial Highlights

Product sales up 34% to $504 million

Total revenues up 31% to $575 million

Net cash provided by operating activities up 33% to $183 million

Page 5: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

5

Total Revenues

Q2 07 Q2 06 Growth$m $m %

Product Sales 504.2 376.0 34%

Royalties 64.0 60.4

Other Revenue 6.7 2.7

Total Revenues 574.9 439.1 31%

* New launches contributed 13% to product sales in Q1 2007

Q2 07 Q2 06 Growth$m $m %

Product Sales 81% 410.2 369.8 11% (excl. new launches)

ELAPRASE 42.7 -DAYTRANA 19.9 -FOSRENOL US 19%* 15.5 5.9FOSRENOL EU 9.0 0.3LIALDA 5.0 -DYNEPO 1.9 -

Product Sales 100% 504.2 376.0 34%

Page 6: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

6

Financial Ratios

(on a non-GAAP basis)

Q2 07 Q2 06 HY 07

COGS : Product sales 14% 12% 14%

Gross margin 86% 88% 86%

R&D : Revenues 16% 16% 16%

SG&A (excl. D&A) : Product sales 49% 51% 47%

EBITDA margin 29% 30% 31%

This slide contains non GAAP financial measures. They exclude intangible asset amortization charges, the accounting impact of share-based compensation and the effect of certain cash and non-cash items, both recurring and non-recurring, that Shire's management believes are not related to the core performance of Shire’s business.

Page 7: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

7

Q2 2007 HighlightsNew River acquisition

JUVISTA license agreement with Renovo

$1.1 billion convertible bond

ADHDVYVANSE

Launched July 2 – 2.8% market share*

sNDA for adult indication filed during the quarter

INTUNIV (SPD503) – Approvable letter received

SPD465 – Approvable letter received

GILIALDA

Launched in Q1

Latest weekly market share – 8.7% of NRx and 6% of TRx *

Very positive reaction from patients and physicians

SOURCE: IMS NGPS – as at September 7, 2007

Page 8: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

8

Portfolio Highlights

Human Genetic TherapiesELAPRASE

Now available in 33 countries

REPLAGAL

Approved in 41 countries;

REPLAGAL sales continue to show significant growth with new patients starting therapy through in European markets as well as through geographic expansion into Canada, Latin America and Japan;

GA-GCB

Phase 3 clinical program consisting of 3 trials is currently enrolling patients

Renal FOSRENOL

Now available in 21 countries

Launched in Italy, Canada, and Slovak Republic

DYNEPO

Launched in Germany, UK, Ireland and Italy

Page 9: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

9

0

2

4

6

8

10

12

14

16

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

8.0%

9.0%

Actual TRx NRx Share TRx Share

Actual TRx 1 3 7 9 12 14

NRx Share 0.8% 3.7% 5.9% 6.6% 6.9% 8.1%

TRx Share 0.3% 1.4% 2.7% 3.6% 4.4% 5.4%

March April May June July Aug

LIALDA – Good launch uptake Monthly Rx

Source: IMS NGPS

Rx

(000’s)

Page 10: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

10

JUVISTA - (human recombinant TGFβ3)

Phase 2 Clinical Trial 0050 Highlights

Trial meets its primary endpoint and is highly statistically significant (p<0.0001)

Demonstrates clinical efficacy of Lonza manufactured, microbiallyderived, drug substance, proposed to be used in Phase 3 trials and commercial supply

Supports 200ng/100�l/linear cm of wound margin as an appropriate dose for Phase 3 studies and establishes a broad response range (50-500ng)

Fifth statistically significant Phase 2 efficacy trial reported for JUVISTA

Page 11: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

VYVANSE – Launch update

Page 12: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

12

VYVANSE is positioned as a new class of ADHD medication not just a replacement to AXR

Page 13: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

13

Key attributes to support VYVANSE as an NCE in a new class

The first Pro-drug Stimulant

Consistent time to maximum concentration of d-amphetamine from patient to patient

Significant efficacy throughout the day, even at 6:00 PM

Adverse event profile that is mild to moderate in severity and incidence decreases over time

Significantly lower abuse related liking effect than an equivalent oral dose of d-amphetamine

5

Page 14: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

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0

4000

8000

12000

16000

20000

24000

06-Jul13-Jul

20-Jul27-Jul

03-Aug10-Aug

17-Aug24-Aug

31-Aug

Weekly Coupon Redemptions

Weekly RX Data

Weekly TRxs are separating from weekly coupon redemptions demonstrating that patients are refilling

SOURCE: IMS Daily Rx & PSKW

• Every redeemed coupon is accompanied by an Rx

• Only one coupon (30 capsules) can be redeemed per patient

Page 15: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

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-1.00%

+2.90%

-2.0%

-1.0%

0.0%

1.0%

2.0%

3.0%

6/22 6/29 7/6 7/13 7/20 7/27 8/3 8/10 8/17 8/24 8/31

Adderall XR Vyvanse Concerta Strattera Generic MPH Generic AMPH

SOURCE: IMS NGPS - Universe

VYVANSE is taking market share from all products in the ADHD category, not just ADDERALL XR

Rx Share Change by ADHD ProductSince VYVANSE Launch

Page 16: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

16

VYVANSE patients are coming from AXR and other brands

5,335 patients started on VYVANSE have enrolled and completed baseline surveys

87% had used a prescription for ADHD prior to VYVANSE

42%

13%11%

34% AXRConcertaFocalin XROther

Source: VYVANSE New Start Patient Experience program

Page 17: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

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n=125

Very severe interference

No Interference

Level of Interference

3.5

3.6

3.8

3.4

6.1

6.7

6.0

6.2

1 3 5 7 9

Social Interactions

Homework

Family Interactions

School Activities

Before VYVANSEWith VYVANSE (average 33 days)

12

No interference Very severe interferencen=125

With use of VYVANSE, ADHD interfered significantly less with life’s activities among children previously using ADDERALL XR

Page 18: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

18

Back to School is not a one-two week event; It runs through October

ADHD Market (IMS NGPS)Weekly TRx Volume

2007 actual through 9/7/2007 (week 36)

450

500

550

600

650

700

750

800

850

Wk 1 Wk 3 Wk 5 Wk 7 Wk 9Wk 1

1Wk 1

3Wk 1

5Wk 1

7Wk 1

9Wk 2

1Wk 2

3Wk 2

5Wk 2

7Wk 2

9Wk 3

1Wk 3

3Wk 3

5Wk 3

7Wk 3

9Wk 4

1Wk 4

3Wk 4

5Wk 4

7Wk 4

9Wk 5

1

TRxs

in 0

00's

ADHD- 2007 ADHD- 2006

"Back to School" season

Vyvanse launch in July

2007

Labor Day Holiday

Page 19: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

19

Successor Molecules (Lexapro, Nexium) follow a different pattern than line extensions such as AXR

Successor Molecule Launch% Conversion of Original Brand & Generics (based on TRx volume)

% Conversion = New Product TRx/ (New Product TRx + Original Brand TRx + Generic of Original TRx)

0%

10%

20%

30%

40%

50%

60%

70%

80%

Month 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9Month 10Month 11Month 12Month 13Month 14Month 15Month 16Month 17Month 18Month 19Month 20Month 21Month 22Month 23Month 24

% C

onve

rsio

n

LEXAPRO NEXIUM VYVANSE ADDERALL XR

Nexium

Lexapro

Vyvanse

Adderall XR

Page 20: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

20

Managed Care update

Coverage is progressing as planned:

6-9 month post-launch review period on adding new products to formulary is common

All targeted plans have received clinical information on VYVANSE

Negotiations with numerous plans are progressing

Parity with AXR formulary status expected by 18 months

Page 21: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

21

Managed Care Tier Status has only modest impact on share in ADHD

9.2% 10.0% Strattera

19.9% 22.8%Concerta

25.3% 28.1%Adderall XR

Tier 3Tier 2

Source: IMS PlanTrak June 2007

Page 22: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

22

Summary

VYVANSE rapid launch uptake

Tracking in line with the industry’s best successor molecule launches

Patients starting on coupons are refilling Rxs

Back to school is not a one-two week event, but lasts at least two full months

Physicians and Patients are providing very positive feedback on their clinical experience with VYVANSE

Coverage is progressing as planned

VYVANSE has tremendous growth potential beyond 2009

Very strong IP

Europe

Potential for other indications

Page 23: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

23

Strong market exclusivity for growth drivers

2012

2016

2018

2020

2023

2012

2010

2012

2013

2009

2000 2005 2010 2015 2020 2025

DYNEPO

ELAPRASE*

FOSRENOL

LIALDA^

VYVANSE

Patent Life Regulatory Exclusivity

^ Currently no generic approval pathway for locally acting drugs*Orphan Drug

EU 2017

Page 24: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

24

Shire has one of the strongest late-stage pipelines in the Specialty Pharma sector

20102007 20092008 2011-2015

ProductLaunches

Eight potential launches over a 30 month period from 2006-2008

* Approvable letter received

VYVANSE

DYNEPO

LIALDA / MEZAVANT

INTUNIV*

SPD465*GA-GCB

ELAPRASE CNS

SANFILIPPO

MLD

CEPO

SPD493

JUVISTAFOSRENOL - CKD

FOSRENOLEU

ELAPRASE EU

DAYTRANA EU

Seasonique

VYVANSE EU

Page 25: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

25

Business Development Strategy – What’s Next?

Specialty biopharmaceutical company

Seek drugs with strong competitive position and intellectual property

Address the needs of the specialist physician

Treatment of symptomatic disorders

Concentrate resources on lower-risk projects with relatively fast development timelines

Small and efficient sales forces

In-license/acquire products with potential peak sales of $300 - $500 million

Page 26: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

26

Concluding Remarks

2007 guidance upgraded as revenue growth accelerates revenue growth to be at least 25% for 2007 (previous guidance low 20% range)

Excellent H1 ‘07 results Successful ongoing launches

Continuing to demonstrate our ability to execute

VYVANSE rapid launch uptake – 2.8% market share*

ELAPRASE – rapid uptake in US and EU

LIALDA – 8.7% NRx, 6% TRx*

FOSRENOL – strong start in Europe

DYNEPO – launched in Q1 2007, good reception

Good progress in strengthening our R&D pipeline

SOURCE: IMS NGPS – as at September 7, 2007

Page 27: Matthew Emmens, CEO Shire plc September 20, 2007investors.shire.com/~/media/Files/S/Shire-IR/...Sep 20, 2007  · This slide contains non GAAP financial measures. They exclude intangible

Questions and Answers

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