Shire plc February 21, 2008investors.shire.com/~/media/Files/S/Shire-IR/... · 2015. 3. 5. ·...

64
Full Year 2007 Results Shire plc February 21, 2008

Transcript of Shire plc February 21, 2008investors.shire.com/~/media/Files/S/Shire-IR/... · 2015. 3. 5. ·...

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Full Year 2007 Results

Shire plcFebruary 21, 2008

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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 including, but not limited to, the successful development of JUVISTA® (Human TGFβ3) and velaglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the launch and establishment in the market of VYVANSE™(lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder (“ADHD”)); the impact of competitive products including, but not limited to, the impact of those on Shire’s 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; 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.

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Agenda

Introduction and Product Highlights Matthew Emmens

2007 Financial Review Angus Russell2008 Guidance

Pipeline Review Michael Cola/Sylvie Gregoire

VYVANSE Update Michael Cola

Concluding Remarks Matthew Emmens

Questions & Answers All

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Matthew Emmens CEO

Introduction and Product Highlights

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Introduction Excellent performance in all areas of the business

Strong product sales reflecting good results and successful product launches across all areas of our business

Executing our strategy

6 launches in past two years: FOSRENOL, ELAPRASE, DAYTRANA, LIALDA, VYVANSE, DYNEPO

Strong track record of approvals or “approvables” in past four years

Robust intellectual property for key growth driving products

Rich pipeline with a focus on orphan drugs and specialist products treating symptomatic disorders

16+ potential launches from 2008-2015 (9 from new products)

Global expansion into new markets (South America, Russia, Mexico, Australia, Japan)

2008 revenue growth expected to be in the mid to high teens and positive revenue growth through 2010

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2007 Financial Highlights

Product sales up 41% to $2.17 billion

New Products sales:

23% of total sales for 2007 versus 6% in 2006

32% of total sales for Q4 2007 versus 12% in Q4 2006

Total revenues up 36% to $2.436 billion

Non GAAP Earnings per ADS up 38% to $2.95

Dividend up 20%

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Product HighlightsADHD franchise exceeds 31% US market share

VYVANSE

Promotion began 3rd week July 2007– 6% market share*

Adult indication PDUFA date – April 28, 2008

DAYTRANA

Enhanced process and improved ease of use

Regulatory submission was filed for product approval in the EU

GI franchise 26% share of US oral mesalamine market

LIALDA / MEZAVANT

Latest US weekly market share – 9.8% of NRx and 8.9% of TRx *

Launched in the UK during Q4 2007 and in Canada January 2008

Further launches in EU planned in 2008

PENTASA

Latest US weekly market share – 17.1% of TRx*

*SOURCE: IMS NGPS weekly data – as at February 18, 2008

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Product HighlightsHuman Genetic Therapies

ELAPRASE

Best in class Lysosomal Storage Disease launch

Now approved in 37 countries

Additional geographical expansion planned

REPLAGAL

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

Approved in 41 countries

Renal FOSRENOL

European launch saw rapid take up of FOSRENOL with patient shares 10 months post launch at 12% in Germany and 19% in France

Successful Shire initiated FDA Advisory Committee has provided a clear regulatory pathway for approval of FOSRENOL for pre-dialysis CKD patients

Now available in 24 countries

DYNEPO

Launched in several EU countries in 2007

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Business Development HighlightsNew River Pharmaceuticals

Global rights, full ownership and control of VYVANSE’s development program

Acquired five pipeline compounds in new technologies and new markets

Worldwide rights (ex-EU member states) from Renovo plc:

JUVISTA, a novel biological treatment for the prevention and reduction of scarring

Ex-US rights from Amicus Therapeutics Inc:

AMIGAL ™, Fabry disease (Phase 2)

PLICERA ™, Gaucher disease (Phase 2)

AT2220, Pompe disease (Phase 1)

Exclusive rights (ex US and Japan) from Alba Therapeutics Corp:

SPD550 in Phase 2 development for the treatment of Celiac disease

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Angus RussellCFO

2007 Financial Review

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2007 2006 Growth

$m $m

Product Sales 2,170.2 1,535.8 41%

Royalties 247.2 242.9

Other Revenues 18.9 17.8

Total Revenues 2,436.3 1,796.5 36%

2007 2006 Growth

$m $m

Product Sales 661.3 427.6 55%

Royalties 61.8 61.1

Other Revenues 1.4 8.3

Total Revenues 724.5 497.0 46%

FY

Q4

Total Revenues

Sales from New Launches (% total product sales)

1319

23

32

05

101520253035

Q1 Q2 Q3 Q4

2007%

2007 Q4 07$m $m

Established Products 1,680.8 17% 451.7 21%

ELAPRASE 181.8 57.4LIALDA 50.5 29.2FOSRENOL US 62.1 14.2FOSRENOL EU 40.1 12.0VYVANSE 76.5 65.9DAYTRANA 64.2 23.0DYNEPO 14.2 7.9

New Product Sales 489.4 * 209.6

Total Product Sales 2,170.2 41% 661.3 55%* 23% of FY product sales

Growth Growth

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Major Product Sales2007 2006 Sales US RX*

$m $m Growth Growth

ADDERALL XR 1,030.9 863.6 19% 16% 3%

VYVANSE 76.5 - n/a n/a

DAYTRANA 64.2 25.1 156% -10% 166%

PENTASA 176.4 137.8 28% 25% 3%

LIALDA 50.5 - n/a n/a

FOSRENOL 102.2 44.8 128% 123% 5%

CARBATROL 72.3 68.3 6% 11% -5%

XAGRID 66.8 53.3 25% n/a

ELAPRASE 181.8 23.6 670% n/a

REPLAGAL 143.9 117.7 22% n/a*Source: IMS data

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ADHD Mkt Avg FY Mkt ADHD Mkt Avg Q4 MktTRx ('000)* Share $M TRx ('000)* Share $M

Sales Demand 37,333 1.8% (1) $68.4 9,818 4.7% (2) $47.2

Stocking $50.3 $40.5

Underlying Gross Sales (3) $118.7 100% (3) $87.7 100%

Sales Coupons ($25.0) (21%) ($12.4) (14%) 36% 25%

Wholesaler discounts and rebates ($17.2) (15%) ($9.4) (11%)

Net Sales $76.5 64% $65.9 75%

* Per IMS data

Notes1 FY - Revenue per TRx = $3.41 (price per unit) x 29.6 units per TRx2 Qtr - Revenue per TRx = $3.41 (price per unit) x 30.2 units per TRx3 Includes the recognition of original launch stocks of $57.4m (FY) of w hich $36.9m w as recognised in Q4

2007 Q4 2007

VYVANSE – Gross to Net Sales

Sales deductions will trend towards a

long term rate of ~ 28% as rebates increase partially offset by coupons reducing over time

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ADHD Mkt Avg FY Mkt ADHD Mkt Avg Q4 MktTRx ('000)* Share $M TRx ('000)* Share $M

Sales Demand 37,333 2.1% (1) $93.0 9,818 2.1% (2) $25.3

Stocking $6.3 $2.8

Underlying Gross Sales $99.3 100% $28.1 100%

Sales Coupons ($13.2) (13%) ($1.4) (5%)

Returns (3) ($5.9) (6%) 35% ($0.6) (2%) 18%

Wholesaler discounts and rebates ($16.0) (16%) ($3.1) (11%)

Net Sales $64.2 65% $23.0 82%

* Per IMS data

Notes1 FY - Revenue per TRx = $3.98 (price per unit) x 29.4 units per TRx2 Q4 - Revenue per TRx = $3.98 (price per unit) x 30.7 units per TRx3 Includes Voluntary Market w ithdraw al (4%)

2007 Q4 2007

Daytrana – Gross to Net Sales

Low in Q4 due to expiry of 2007

coupon program.

Sales deductions will trend towards long term rate of

~25%.

Coupons expected to moderate to 10% in 2008

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Royalties

2007 2006 Growth$m $m (%)

3TC 145.3 150.9 -4% *

ZEFFIX 41.0 34.8 18% **

Other *** 60.9 57.2 6%

Total 247.2 242.9 2%

*Includes favourable foreign exchange movements of 4% **Includes favourable foreign exchange movements of 8% ***Includes REMINYL/RAZADYNE

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Key Financial Ratios (% of net product sales)(on a non-GAAP basis)

COGS 14% 14% 13% 13%

Gross margin 86% 86% 87% 87%

R&D 18% 19% 19% 20%

SG&A 45% 46% 52% 54%

Operating EBITDA (1) 24% 21% 16% 14%

Operating EBITDA (% total revenue) (2) 31% 29% 28% 25%

(1) Excluding royalties(2) Including royalties

This slide contains non GAAP financial measures. They exclude intangible asset amortization in respect of acquired intellectual property 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.

2007 2006

Inc FAS123R

Excl FAS123R

Inc FAS123R

Excl FAS123R

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Net Income/EPS – Actual

Net income ($m)

- GAAP (1,451.8) (1,451.8) 278.2 278.2

- Adjustments 2,003.1 1,983.1 84.2 52.7

- Non GAAP(1) 551.3 531.3 362.4 330.9 52% 61%

EPS - ADS (diluted)

- GAAP (806.1c) (806.1c) 163.8c 163.8c

- Non GAAP(1) 294.6c 284.1c 213.0c 195.0c 38% 46%

Growth %

Inc FAS123R

Excl FAS123R

2007 2006

Inc FAS123R

Excl FAS123R

Inc FAS123R

Excl FAS123R

(1) These are non GAAP financial measures. They exclude intangible asset amortization charges 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.

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Cash generation

Cash flow – Dec YTD 2007

Cash outflow for 2007 : -355

+645

Net tax/interest

Share issue

Convertible

+237

Millions of USD

-217

-7

Asset sales

+877

Other Financing (inc Treasury stock, dividend etc.)

New River acquisition

Fixed asset purchases-124

-2,601

+1,100

-265 In-licensing payments & milestones

(2) Shire has a revolving credit facility of $1.2bn which was undrawn at 31 December 2007

(1) Shire’s balance of cash and cash equivalents at 31 December 2007 includes $40m of restricted cash and is available to finance payments due to TKT dissenting shareholders (provision at 31 December 2007 of $480m)

Cash at 31/12/06 1,157

Cash outflow in 2007 (355)

Cash at 31/12/07 (1) 802

Convertible debt (1,100)

Net debt at 31/12/07 (2) (298)

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2007 Actual v Guidance

Non GAAP (Exc FAS 123R) Actual Guidance

Revenue growth 36% > 30%

R&D - GAAP ($m) 566.6

Less Renovo (75.0) Amicus (50.0) Alba (25.0) Noven (5.9) FAS 123R (17.0)

R&D - Non GAAP ($m) 393.7 $365m to $375mas % of Net Product Sales 18%

SG&A - GAAP ($m) 1,041.7 Less Net legal settlement (17.0)

FAS 123R (52.7)

SG&A - Non GAAP ($m) 972.0 $955m to $975m

as % of Net Product Sales 45%

17% - 18%

46% - 47%

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2007 Actual v Guidance (continued)Actual Guidance

Amortisation ($m) 95.0 versus 2006: + 66% + 70%

Depreciation ($m) 59.3versus 2006: + 37% + 30%

Depreciation & Amortisation 154.3

Tax charge - US GAAP 55.5 Less non GAAP adjustments* 87.8

Non GAAP Charge 143.3

Non GAAP Income before tax 692.8

Effective Tax rate 21% Low 20%'s

* see Appendix (EPS Reconciliation slide)

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Inc FAS123R Exc FAS123R

Revenue growth Mid to high teens

Vyvanse Product Sales $350 - $400m**

R&D $465 - $490m $450 - $475m

SG&A $1,125 - $1,165m $1,080 - $1,120m

Capex $320- $350m

Depreciation Growth ~50%

Non GAAP Tax Rate ~ 23%

Fully diluted share capital 590m

Interest - after tax add back $13m

* Non GAAP net income for 2008 will include FAS123R and will exclude : amortisation(1) , balance of gains on the sale of non-core products ($29m) and upfront payments & milestones in respect of in-licensed products.(1) Amortisation forecast: 25% growth vs 2007.** Assumes the adult indication is launched by mid year 2008.

2008 Non GAAP Guidance*

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Michael Cola, President, Specialty Pharmaceuticals

Sylvie Gregoire, President, HGT

Pipeline Review

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R&D investment will drive growth

Focus on products for the specialist market and rare genetic diseases where there is low competitive intensity.

New indications and geographic expansion will maximize the return on our currently marketed products

Acquire products with relatively low technical risk of development in areas where we have expertise

Target the acquisition of companies in new areas that form the cornerstone of a new Business

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Shire R&D portfolio is well-balanced with both short and long term opportunities for growth

Development Phase

ADHDHGT

Intuniv

VYVANSE – Adult-US

Registration

Daytrana - EU

Phase III

Lialda –Diverticulitis

Fosrenol CKD

VYVANSE - EU

Women’sHealth

DaytranaAdolescent

Velaglucerase

Phase II

Women’s Health

Juvista (SPD 538)

Larazotideacetate

(SPD 550)

Amigal

Plicera

AT2220

Phase I

Elaprase IT

Research-Preclinical

Sanfilippo ERT

MLD ERT

GI Renal Other

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Shire has one of the strongest mid to late-stage pipelines in its sector

20102007 20092008 2011-2015

DAYTRANA ADOLESCENT

VELAGLUCER-ASE ALFA

PLICERA

AMIGAL

AT2220

ELAPRASE IT

SANFILIPPO ERT

MLD ERT

VYVANSE EU

JUVISTA

LIALDA DIVERTICULITIS

SPD 550

WOMEN’S HEALTH PORTFOLIO

VYVANSE

DYNEPO

LIALDA / MEZAVANT

FOSRENOLEU

ELAPRASE EU

DAYTRANA EU

INTUNIV**

VYVANSE ADULT

FOSRENOL -CKD

*16+ potential launches from 2008-2015 - 9 from new products

*Subject to regulatory approvals**Approvable letter received

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0

100

200

300

400

500

2005 2006 2007 2008

Spec PharmaHGT

R&D investment

18%18%19%21%Shire Total

13%13%14%19%Spec Pharma

42%45%74%86%HGT

2008200720062005

R&

D In

vest

men

t ($M

)

R&D investment as a percentage of sales

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Balanced R&D investment

Ph3b/4 & Lifecycle Programs

(44%)

Ph3 Programs(22%)

Research – Ph2Programs

(19%)

Post-Approval Commitments

(15%)

2008 $450 – 475M*

*Excludes SFAS No. 123(R)

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Specialty Pharma Portfolio

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Program PhII PhIII Registration

VYVANSE Adult ADHD - USDaytranaADHD - EU

JuvistaPrevention & treatment of scarringSPD 550Celiac disease

Lialda DiverticulitisVYVANSEADHD - EU

IntunivNon-stimulant for treatment of ADHD

Specialty Pharma programs focus on lifecycle opportunities and new product development

DaytranaAdolescent ADHD - US

FosrenolCKD (pre-dialysis)

Marketed Product Life cycle opportunities

New populations, indications and

geographic expansion

New Product Development:Existing & New Therapeutic Areas

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HGT Portfolio

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CommercialPh II/IIIPh I/IIPreclinical IND Tox

POC

HGT product pipeline focusing on new platforms and technology

ReplagalFabry DiseaseElapraseHunter Syndrome

VelagluceraseGaucher Disease

Elaprase ITHunter – CNSSanfilippoSanfilippo ERT

MLDMetachromaticLeukodystropy ERT

AmigalFabry DiseasePliceraGaucher DiseaseAT2220Pompe Disease

Marketed Product Support

Grow ERT Franchise

New Platform: Pharmacological

Chaperones

New Technology: CNS Diseases

Research Expand pipeline through internal Research capability

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R&D news flow

2H-091H-08 1H-092H-08

VYVANSE adult ADHD launch (US)

JUVISTA Ph2 data

ELAPRASE Geographic Expansion

AT2220 Ph2 Initiation

FOSRENOL CKD launch (US)

VELAGLUCERASE Ph3 enrollment complete

ELAPRASE IT Ph1 Initiation

SANFILIPPO and MLD tox programs

DAYTRANA EU launch

SPD550 Ph2 data

AMIGAL Ph3 Initiation

PLICERA Ph2 data

INTUNIV launch

DAYTRANA adolescent sNDAfiling

VELAGLUCERASE filing

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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 2017Revisions as of March 5, 2008

19

2000 2005 2010 2015 2020 2025

20232012

20122012DYNEPO

2013**2019ELAPRASE*

20182009FOSRENOL

20202010LIALDA^

VYVANSE

Patent Term Regulatory Exclusivity

20202011REPLAGAL*

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Projected Patent^ and Regulatory Exclusivities*For Current Pipeline Products

2019

2021

2019

2018

2018

2010 2015 2020

AMIGAL 2

VELAGLUCERASE 1

ELAPRASE IT 1

PLICERA 2

AT-2220 2

1. Biologic Product2. Orphan Designation Obtained or Being Sought- 7 yr exclusivity in US; 10 year exclusivity in EU^ Last to expire of currently published patent applications, regardless of jurisdiction; applications not yet granted.* Exclusivity for new, approved biologics in EU is 10 years; currently no generic approval pathway in US. Exclusivities for new chemical entities

(non-biologics) are: US 5 yrs; EU 10 yrs.Revisions as of March 5, 2008

JUVISTA 1

INTUNIV

SPD-550 2019

2021

2019

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SummaryBalanced R&D investment of approximately 18% of product sales in2008

Strong news flow over the next 24 months

Initiation of one Ph1 program

Initiation of one Ph2 program

Ph 2 data from three new products

Initiation of one Ph3 program

Completion of two Ph3 programs and subsequent regulatory submissions

One new product launch

Four launches of market expansion programs of existing products

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Michael ColaPresident, Specialty Pharmaceuticals

VYVANSE – Launch Update

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Introduction

Launch Progress

Adult Indication

Managed Care Update

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Key attributes of VYVANSE support differentiation as a NCE

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

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VYVANSE Launch Performance

Over 900,000 prescriptions since launch

Over 50% (23,000) of high volume physicians prescribing

Double industry norms for promotional campaign recall and recognition

* Projection based on daily prescription volume

+6.3%*

0%

1%

2%

3%

4%

5%

6%

7%

6/22

6/29 7/6 7/13

7/20

7/27 8/38/10

8/17

8/24

8/31 9/7 9/14

9/21

9/28

10/5

10/12

10/19

10/26 11

/211

/911/1

611

/2311

/30 12/7

12/14

12/21

12/28 1/41/1

11/1

81/2

5 2/1 2/82/15

TRx

Sha

re

Labor Day

ThanksgivingChristmas/New Year’s

MLK

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VYVANSE launch has been tracking in line with other blockbuster CNS drug launches

Source: IMS NPA

0

100,000

200,000

300,000

400,000

500,000

600,000

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Launch Month

TRx

Paxil Risperdal Zyprexa Seroquel Lunesta Strattera Vyvanse

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Highest volume ADHD prescribers are adopting VYVANSE, and trickle down is occurring with lower level prescribers

Source: IMS

Vyvanse TRx Market Share Uptake Comparison

3.4%4.1%

4.8% 5.2% 5.6%3.6%

4.7%5.7%

6.6%7.2% 7.7%

4.5%5.8%

6.9%7.8%

8.6% 9.1%

0.1% 1.2%2.6%

0.1%

1.6%0.1%2.0%

0%1%2%3%4%5%6%7%8%9%

10%

Jun-07 Jul-07 Aug-07 Sep-07 Oct-07 Nov-07 Dec-07 Jan-08Month

TRx M

arke

t Sha

re

All Top 43,000 Top 14,000

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Coupons are declining as a % of TRx as New Starts convert to fully paid TRxs

Coupons are now less than 15% of total prescriptions

% of Weekly TRx that are Coupons

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

7/20/0

77/2

7/07

8/3/07

8/10/0

78/1

7/07

8/24/0

78/3

1/07

9/7/07

9/14/0

79/2

1/07

9/28/0

710

/5/07

10/12

/0710

/19/07

10/26

/0711

/2/07

11/9/

0711

/16/07

11/23

/0711

/30/07

12/7/

0712

/14/07

12/21

/0712

/28/07

1/4/08

1/11/0

81/1

8/08

1/25/0

82/1

/082/8

/08

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Level of Interference

3.6

5.7

6.8

5.8

5.9

3.2

3.3

3.5

1 3 5 7 9

Social Interactions

Homework

Family Interactions

School Activities

Adderall XRWith VYVANSE (avg. 6 weeks)

n=1960*p<0.01 vs. Before VYVANSE

Q: Before/since taking VYVANSE, how much did/do your child’s symptoms interfere with school activities?Q: Before/since taking VYVANSE, how much did/do the symptoms interfere with family interactions?Q: Before/since taking VYVANSE, how much did/do the symptoms interfere with homework?Q: Before/since taking VYVANSE, how much did/do the symptoms interfere with social interactions?

Patient reported experience with VYVANSE exceeds what they previously reported on AXR

*

*

*

*

Source: VYVANSE New Start Patient Experience program which includes survey data from over 10,000 parents of children prescribed VYVANSE, of whom 39% previously took ADDERALL XR. Parents were surveyed at their child’s initiation of VYVANSE and after 6 weeks of therapy. Data collected were from July 2007 – January 2008

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At 4 months, VYVANSE is already seen by physicians as the top choice for patients who need additional efficacy

Source: CTS Posttest, November 2007, n=189

Q: Please write in your first choice ADHD medication for treated patients who need additional efficacy?”

0%

5%

10%

15%

20%

25%

30%

% o

f Phy

sici

ans

Vyvanse Adderall XR Strattera Concerta Adderall Focalin XR Daytrana

First Choice for Additional Efficacy

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VYVANSE is also the first choice for patients that need a longer duration of effect

Source: CTS Posttest, November 2007, n=194

Q: Please write in your first choice ADHD medication for treated patients that need a longer duration of effect?”

0%

5%

10%

15%

20%

25%

30%

35%

40%

% o

f Phy

sici

ans

Vyvanse Concerta Adderall XR Daytrana Strattera Focalin XR

First Choice for Longer Duration of Effect

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VYVANSE Adult Indication

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The VYVANSE adult claim represents a significant opportunity for growth in 2008

VYVANSE Adult Indication:

Filed on June 29, 2007

PDUFA date is April 28, 2008

Commercial launch planned for Q2 2008

Strong effort to both physicians and consumers

Duration important for adult day

Lower abuse related liking effect compared to equivalent oral dose of d-amphetamine

New opportunity to grow the adult market

Efforts by all companies to expand adult market have been minimal since promotion of AXR was discontinued

No major consumer efforts in several years

* There has been no adult promotion to date

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0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

2003 2004 2005 2006 2007

6-12 13-17 18+

Current ADHD Market Growth is Primarily Driven by Adults

Source: Age Data - Verispan’s Vector One National; Annual Growth – IMS NPA

Tota

l Pre

scrip

tions

(000

)

Percent Market Growth by Age Segment

+20.4%+25.2%

+17.3%

+15.4%

+10.9%

+14.9%

+10.5%

+5.0%

-0.7%

+9.1%

-3.0%

-5.8%

+14.4%

+3.1%

+2.3%

+16.8% +6.1% +3.2% +5.7%Annual Growth: +17.3%

5-Year CAGR:

18+: 16.4%

13-17: 4.8%

6-12: 1.4%

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Adults represent the largest and fastest growing segment of the ADHD market

% of total ADHD prescriptions by age category

Source: Verispan’s Vector One: MAT 12/07

36%41%

23%

Adult18+

Child0 – 12 yrs

Adolescent13 – 17 yrs

200736.3MM TRx

28%

46%

25%

200223.4MM TRx

Adult18+

Child0 – 12 yrs

Adolescent13 – 17 yrs

28%

23%

36%41%46%

25%

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The adult ADHD market remains substantially underdeveloped

Popu

latio

n*N

= 29

6.6

MM

Patient Group by Age

% Prevalence** Drug Treated***

81%4.0MM

24%2.4MM

Total Patients

4.9MM

* US Census**Prevalence data calculated from data presented from Kessler, 2006 and CDC/NHIS *** Drug Treated=Number diagnosed * drug treatment rate

9.9MM

School Age (4-17)(24.3%)72 MM

Adults(75.6%)224 MM

6.9%

4.4%

Untreated

0.9MM

7.5MM

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39%

43%

46%

20%

30%

40%

50%

Shar

e of

Pre

fere

nce

Vyvanse

Child Adolescent Adult

Pre-launch market research has shown that physicians stated preference for VYVANSE in adults is even greater than in children

SYMPTOMATIC PATIENTS

Source: FutureScope market research, April 2007, n= 500 physicians

Child<Adol/Adult (p<0.05)

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15%

17%

19%

21%

23%

25%

27%

Jan-04

Mar-04

May-04

Jul-0

4Sep

-04Nov-04Jan

-05Mar-

05May

-05Jul-0

5Sep-05Nov-05Jan

-06Mar-

06May

-06Jul-0

6Sep-06Nov-06

% S

hare

of A

dult

Tota

l Pre

scrip

tions

VYVANSE share in adults will increase with label change/promotion of the indication as did AXR

Source: Verispan Vector One

ADDERALL XR®

Adult Approval

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Shire already holds the market lead by a wide margin among brands in Adult ADHD

0%

5%

10%

15%

20%

25%

30%

Adderall XR Concerta Strattera Focalin XR

Monthly Market Share

Source: Verispan’s Vector One: National

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VYVANSE differentiation will increase with release of new clinical data in 2008

Other

2Q08Flexibility3 new dosage strengths

Mid 08Efficacy, Duration311 Classroom Analog

Mid 08Tolerability310 Dose Optimization

TimingParameters of Differentiation

Studies

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Managed Care Update

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VYVANSE Managed Care Coverage in 9 months exceeds 12 month goal!

ADDERALL XR has outstanding managed care formulary coverage

Our goal was to have VYVANSE achieve parity formulary status to AXR within 18 months of launch; 75% to this goal within 12 months

In total, VYVANSE will have ~80% parity formulary status to ADDERALL XR contracted lives by April 1

We have executed agreements with the top 6 managed care organizations

Lives Covered at Tier 2 (MM)

0

20

40

60

80

100

120

140

160

180

200

3Q07 4Q07 1Q08 April 1, 2008

Plan

Rep

orte

d Li

ves

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DACON holding steady at 1.0, validating and reinforcing Duration message

DACON of ADDERALL XR started out immediately at launch at 1.2 has remained there for many years

DACON of VYVANSE was close to 1.0 at launch and has held steady at 1.0 after 6 months, validating the long duration of effect

Managed Care was skeptical at launch but now is impressed as DACON has held steady and they see this replicated in their own plan level data

0.6

0.8

1

1.2

1.4

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

Month Post-Launch

DACO

N

Adderall XR Vyvanse

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Medicaid Coverage is good and has steadily improved since launch

July 31, 2007: 17% Open AccessSept 31, 2007: 38% Open AccessDec 31, 2007: 58% Open AccessAnticipated Apr 08: >75% Open Access

RI

MA

CA

FL

NC

NJ34

VA

MS

MD

AL

SC

IN

LA

AZ

WA

WI

KY

OK

MN

CO

AR

PA

NYOR

KS

IA

NVNE

ME

SD

MTND

AK

WY

VT

ID

UTWV

HI

NMGA

IL

MI

MO

NH

TX

OH DE

CT

TN

DC

*Open Access based on % of ADHD Rxs in Medicaid; Note: AZ has varying access by plan

Source: IMS November 2007 ADHD TRx’s

February 15, 2007: 68% Open Access*

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VYVANSE – Positioned for the long term

Outstanding IP protection to 2023 US / 2024 EU

Further investment

Phase IV research to strengthen product profile

Development of the adult market

Penetration into nascent Global markets

Opportunities beyond ADHD

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Matthew Emmens CEO

Concluding remarks

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Concluding Remarks

Excellent 2007 results

Successful ongoing launches

Accelerating new product sales representing 23% of total sales for full year

2007 and 32% of total sales for Q4 2007

Successful positioning of VYVANSE for continued growth

Good progress in strengthening our pipeline by in-licensing rights to 5 biological and small molecule products

16+ potential launches 2008 - 2015

9 of which are new products

2008 revenue growth expected to be in the mid to high teens range and positive revenue growth through 2010

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Questions and Answers

All

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APPENDIX

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EPS Reconciliation2007 2007 2006 2006

$m cents/ADS $m cents/ADS

Net income for diluted EPS (ADS) (1,451.8) (806.1c) 278.2 163.8cCost of product sales fair value adjustment - - 47.0 27.9c

In-licensing and milestone payments 155.9 82.2c 80.5 47.4c

Gain on disposal of product rights (127.8) (66.9c) (63.0) (37.2c)

Legal settlement provision 17.0 9.0c - -

Integration New River/TKT 9.2 4.8c 5.6 3.3c

Intangible asset amortization 95.0 50.1c 57.4 33.6c

FAS 123R - Catch up charge 29.2 15.4c - -

Gain on disposition of discontinued ops - - (40.6) (24.0c)

New River in-process R&D charge 1,866.4 1,028.1c - -

Taxes on above adjustments * (61.8) (32.5c) (34.2) (19.8c)

Non GAAP net income / EPS (ADS) (Inc FAS123R) 531.3 284.1c 330.9 195.0c

FAS 123R 46.0 24.2c 43.0 24.9c

Taxes on FAS 123R * (26.0) (13.7c) (11.5) (6.9c)

Non GAAP net income / EPS (ADS) (Exc FAS123R) 551.3 294.6c 362.4 213.0c

* Total Tax on 2007 Non GAAP Adjustments - $87.8m