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Deutsche Bank 32 nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire plc

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Page 1: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

Deutsche Bank32nd Annual Healthcare ConferenceMay 2, 2007

Matthew Emmens, CEOShire plc

Page 2: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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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, 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 dates of SPD503 (guanfacineextended release) (ADHD) and SPD465 (extended release triple-bead mixed amphetamine salts) (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.; 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 plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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A series of transactions and approvals has created a solid foundation for the future and transformed Shire…

TKT acquisition diversified our portfolio and moved Shire into high-value, niche, biologic products with long exclusivity

Early stage TKT/HGT pipeline should drive significant growth in 2013 and beyond

Barr settlement created more certainty for our ADHD franchise

Recent product approvals and lifecycle extensions fuel strong growth going forward

Acquisition of New River underpins our ADHD franchise long-term

The ownership of the patented CARRIERWAVE platform technology may lead to other pharmaceutical applications

Page 4: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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2007 Highlights - Executing on Strategy

New River Acquisition Completed – April 19

ADHD

VYVANSE – FDA paediatric approval on February 23

ADDERALL XR – Marketing license application for adult indication granted by Health Canada

DAYTRANA – Strong launch continues

GI

LIALDA – Launched on March 19

Very positive reaction from patients and physicians

Page 5: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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2007 Highlights - Executing on Strategy

Renal

FOSRENOL – launched in 7 more countries in 2007 including the UK

20 countries in total

Authorization to launch received in Italy

DYNEPO – Launched in Germany in March

Human Genetic Therapies

ELAPRASE – US and European launches in progress

291 patients globally on therapy by March 31

REPLAGAL – Launched in Japan on February 15

GA-GCB – Phase 3 clinical program has begun with first patients dosed in February

Page 6: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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2007 Newsflow

VYVANSE – launch planned for June

– sNDA for adult indication to be filed with FDA in Q2

SPD503 – paediatric non-stimulant – PDUFA June 24

SPD465 – long-acting stimulant for adults – PDUFA May 21

DAYTRANA – EU filing in H2

Page 7: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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2010201020072007 2009200920082008 2011-20152011-2015

ExpandingGeographic

Reach

LabelExpansion

NewProductLaunch

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

Seven potential new product launches over a 30 month period from 2006-2008

* Launch timing subject to review

VYVANSE

DYNEPO

LIALDA / MEZAVANT

SPD503

SPD465*GA-GCB

Sanfilippo

MLD

CEPO

SPD493

FOSRENOL - CKD

ELAPRASE CNS

FOSRENOLEU

ELAPRASE EU

DAYTRANA EU Seasonique VYVANSE

EU

Page 8: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

Product Launches

Page 9: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire
Page 10: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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VYVANSE

Next generation of ADHD treatment

VYVANSE - innovative and future flagship product for ADHD

Impressive efficacy, extended duration, less potential for abuse

Strong IP until 2024

FDA approval received on February 23, 2007

Awaiting final DEA scheduling

Launch in June is optimal

sNDA for adult indication expected to be filed in Q2 2007

Page 11: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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VYVANSE provides efficacy throughout the day

-10.3 -8.9 -7.7

-48.2*-51.8*-51.5*

-60

-50

-40

-30

-20

-10

0

VYVANSE Placebo

The CPRS was used to assess the duration of therapeutic response in 285 patients by separately analyzing the assessments performed per protocol in the morning (~10 AM), afternoon (~2 PM), and evening (~6 PM). *P<.0001 vs placebo.Adapted from Biederman, et al, Clinical Therapeutics, March 2007

% C

hang

e~10 AM ~2 PM ~6 PM

Median daily dosing time was between 7:30 AM and 8 AM.

Change in Score at Endpoint From Baseline onConners’ Parent Rating Scale (CPRS) Across the Day

Page 12: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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VYVANSE appears to have lessvariability in drug delivery than ADDERALL XR

Con

cent

ratio

n (

Con

cent

ratio

n ( n

g/m

Lng

/mL ))

Time (h) to Maximum Concentration (Time (h) to Maximum Concentration (TmaxTmax))

VYVANSE 70 mg (n=8) (d-amphetamine)ADDERALL XR 30 mg (n=9) (total amphetamine)

Steady-state pharmacokinetics in pediatric patients (ages 6 to 12) in a randomized, 3-way crossover, double-blind study that included VYVANSE, ADDERALL XR, and placebo.Data on file, LDX005. Shire US Inc.

0

50

100

150

200

250

300

0 1 2 3 4 5 6 7 8 9 10 11 12

Page 13: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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74% of Patients Taking VYVANSE Were Much/Very Much Improved (CGI-I)

0

10

20

30

40

50

60

70

80Much improved Very much improved

32% of patients taking VYVANSE responded as “very much improved” where as only 16% of patients taking ADDERALL XR responded as “very much improved”

% o

f Sub

ject

s%

of S

ubje

cts

Muc

h/Ve

ry M

uch

Impr

oved

Muc

h/Ve

ry M

uch

Impr

oved

*P<.0001.CGI-I=Clinical Global Impressions-Improvement (ITT Analysis)Data on file, LDX 003. Shire US Inc.

18%

72%* 74%*

VYVANSEPlacebo ADDERALL XR

Page 14: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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VYVANSE Market Research

Over 1,600 high prescribing physicians have participated in 11 market research projects since January 2006

In the most recent study that included 200 physicians, 3/4ths said they were likely/very likely to prescribe VYVANSE and less than 8% said that they are not likely to prescribe it.

Based on another study with 200 physicians, 93% said they would prescribe VYVANSE.

Over 400 consumers have participated in 5 research projects since October 2006

In one study of 160 caregivers, over 100 had a positive impression of VYVANSE’s product profile relative to the ADHD medication their child is currently taking.

The attraction to VYVANSE is driven by its effectiveness until 6 PM

In another study of 100 caregivers, 92% stated they liked the medication; 88% stated that they are likely or very likely to ask their physicians about VYVANSE.

Page 15: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire
Page 16: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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Profile of LIALDA Attractive to GEs and Patients

GEs rate LIALDA more favorably for UC than Colazal, Asacol or Remicade

98% of GEs reported they intended to prescribe LIALDA for at least one patient

GEs intend to prescribe LIALDA for new starts, patients in flare and patients in remission

55% of patients report they prefer the profile of LIALDA to that of their current medication

66% of patients who knew about LIALDA reported that they would ask their doctor to prescribe it

MCO Pharmacy Directors were more concerned about budget impact from biologics (Remicade, Humira) than the impact from 5-ASA

Survey of 120 GEs, 25 MCO Pharmacy Directors and 160 UC patients

Page 17: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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Launch Progress

Sales Representatives began detailing Lialda on 3/19/2007

Source: IMS NGPS

0

100

200

300

400

500

600

700

800

900

1000

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

3.5%

4.0%

Actual TRx NRx Share TRx Share

Actual TRx 47 69 190 380 565 683 881

NRx Share 0.2% 0.4% 1.0% 1.9% 2.7% 3.2% 4.0%

TRx Share 0.1% 0.1% 0.3% 0.7% 0.9% 1.2% 1.5%

3/9 3/16 3/23 3/30 4/6 4/13 4/20

Page 18: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

Concluding Remarks

Page 19: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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Concluding Remarks

Excellent results – the business continues to perform strongly

Successful launches in 2006 and Q1 2007 with upgraded guidance for full year

Continuing to demonstrate our ability to execute

ADDERALL XR – leading US market share

DAYTRANA - strong launch continues

ELAPRASE – rapid launch in US and EU

LIALDA – approved and launched in Q1 2007, quick uptake

FOSRENOL - strong start in Europe, US position improving

DYNEPO – launched in Q1 2007, good reception

VYVANSE to launch in the US by mid-2007

Early stage pipeline advancing toward clinical development

Shire will continue to evolve in order to maintain its long-term growth

Page 20: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

Questions and Answers

All

Page 21: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

Appendix

Page 22: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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Q1 2007 Financial Highlights

Product sales up 33% to $462 million

Total revenues up 29% to $528 million

EPS – ADS (diluted)

GAAP up 78% 64 cents

Non GAAP* up 39% 75 cents

* This is a non GAAP financial measure which excludes 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 23: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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Q1 2007 Actual v 2007 Guidance(including NRP)

Q1 07 Original Updated Actual FY Guidance FY Guidance

Revenue growth 29% Around 20% Low 20% rangeRevenue growth (excl. launches) 16%

R&D - GAAP ($m) 80.8

Less SFAS 123R (2.3)

R&D - Non GAAP ($m) 78.5 $360m to $380m $340m to $360m

SG&A - GAAP ($m) 213.8

Less SFAS 123R (7.5)

SG&A - Non GAAP ($m) 206.3 $930m to $960m Unchanged

D&A - GAAP ($m) 28.9

Less amortization (15.3) Up 20% approx $70m Up 80% approx $100m

Depn - Non GAAP ($m) 13.6 Up 20% approx. $50m Unchanged

Tax rate 27% 26% Unchanged

New River Integration costs - n/a $10m (to be non GAAPed)

Page 24: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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Most Parents Report that their Child’s ADHD Medication Wears Off before 6 PM

Harris Interactive Omnibus Survey

389 parents surveyed about their child who is currently taking a once-daily ADHD medication in the morning

Conducted October 2006

Results

53% report that their child’s ADHD medication stops working before 6PM

63% report their child’s once-daily stimulant medication works 11 hours or less

Page 25: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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Consistency/Reliability are the most important Attributes of an ADHD medication

Quantitative Research w/750 High Rxers of ADHD medications:

Physicians need for the therapy they prescribe to work the firsttime. They do not like to prescribe again and when they do, theyhave to explain why their first choice did not work.

Physicians want to have their first prescription work with everypatient, the same way, every time and for the long term.

Brain Surgery quantitative study, January 2006

Page 26: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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LIALDA – Impressive Efficacy from a Novel QD Formulation

As the only once daily oral 5-ASA proven to control symptoms and induce remission, LIALDA helps patients overcome the disruption of UC

LIALDA induces remission as measured by stringent clinical and endoscopic endpoints

LIALDA utilizes MMXTM (Multi-matrix) technology to delay initial release of mesalamine to the terminal ileum and ensure that mesalamine is released throughout the colon with just one daily dose.

LIALDA simplifies the route to remission with just two to four tablets taken once a day

Page 27: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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Study 302: Lialda Induced Remission; Asacol Did Not

In Study 302, Lialda 4.8 g and 2.4 g were compared to placebo with a stringent clinical and endoscopic remission primary endpoint (consistent with those used in the Remicade UC trials)

A separate arm using the US formulation of Asacol (2.4 g) was also compared to placebo using the same stringent endpoint

Asacol failed to reach significance vs. placebo on the primary endpoint of remission

Asacol’s failure to induce remission in more patients than placebo is consistent with its labeled indication of “treatment of mildly to moderately active UC”.

This study was not a head to head study; Lialda and Asacol were not compared against each other

Page 28: Matthew Emmens, CEO Shire plcinvestors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/...Deutsche Bank 32nd Annual Healthcare Conference May 2, 2007 Matthew Emmens, CEO Shire

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Launch Progress

Field promotion by 120 reps targeting 8,925 GI physicians began March 19

Shire call activity increased 37% from pre-launch to launch

Shire stocked 26,000 pharmacies with LIALDA prior to launch

Shire has trained a sufficient amount of speakers on the LIALDA data and are available to conduct speaker programs

Branded Direct to Patient campaign planned to commence in May

Latest prescription data: NRx 4.0% and TRx 1.5% share of the branded oral mesalamine market.