33
Matthew Emmens Chief Executive Officer February 3, 2004 Merrill Lynch Healthcare Conference New York

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Page 1: Merrill Lynch Healthcare Conference New Yorkinvestors.shire.com/~/media/Files/S/Shire-IR/...2004/03/02  · 4 647.7 853 1037.3 327 140.3 143.1 0.0 200.0 400.0 600.0 800.0 1000.0 1200.0

Matthew EmmensChief Executive Officer

February 3, 2004

Merrill Lynch Healthcare Conference

New York

Page 2: Merrill Lynch Healthcare Conference New Yorkinvestors.shire.com/~/media/Files/S/Shire-IR/...2004/03/02  · 4 647.7 853 1037.3 327 140.3 143.1 0.0 200.0 400.0 600.0 800.0 1000.0 1200.0

2

A Strategic Review Today…and Beyond

Clear StrengthsHighly successful business modelStrong pipeline of high potential products

Near and mid-term opportunitiesProtect and grow key franchises

Clear StrategySelect, protect and grow major franchisesFocus R&D on late-stage development / key franchisesAggressive business developmentConsolidation & restructuring

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SHIREGROWTH OPPORTUNITY

SHIRESHIREGGROWTHROWTH OOPPORTUNITYPPORTUNITY

Specialty Business

HIGHLY SUCCESSFUL

BUSINESS MODEL

Specialty Business

HIGHLY SUCCESSFUL

BUSINESS MODEL

Portfolio

STRONGAND

VALUABLE

PipelineFlow

EXCELLENT GROWTH

POTENTIAL

Strategic Development

AND OTHER OPPORTUNITIES

Financials

SUCCESSFUL RESULTS

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4

647.7

853

1037.3

327

143.1140.30.0

200.0

400.0

600.0

800.0

1000.0

1200.0

MM

$

Net Sales 647.7 853 1037.3Operating Income 140.3 143.1 327

2000 2001 2002

Specialty Business Specialty Business –– Successful ModelSuccessful Model

High Growth in Revenue & Profitability

27 % CAGR

53 % CAGR

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SHIREGROWTH OPPORTUNITY

SHIRESHIREGGROWTHROWTH OOPPORTUNITYPPORTUNITY

Specialty Business

HIGHLY SUCCESSFUL

BUSINESS MODEL

Portfolio

STRONGAND

VALUABLE

Portfolio

STRONGAND

VALUABLE

PipelineFlow

EXCELLENT GROWTH

POTENTIAL

Strategic Development

AND OTHER OPPORTUNITIES

Financials

SUCCESSFUL RESULTS

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Total Revenue: $1.037 BillionAdderallAdderall®®

11%11%

ProAmatineProAmatine®®

5%5%

PentasaPentasa®®

8%8%

CarbatrolCarbatrol®®4%4%

AntiviralsAntivirals16%16%

OthersOthers13%13%

AgrylinAgrylin®®

12%12%

AdderallAdderall XRXR®®

31%31%

2002 Product Sales & Royalties

Portfolio – Strong and ValuablePortfolio Portfolio –– Strong and ValuableStrong and Valuable

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Specialty Business Specialty Business –– Successful ModelSuccessful Model

Therapeutic Areas of Focus

CNSGIRenalM&A and Licensing

Therapeutic Areas as aboveOther Therapeutic Areas in “specialty” model

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AdderallAdderall®® FamilyFamily

$10,080$38,924

$78,591

$155,648

$238,001

0

100,000

200,000

300,000

400,000

500,000

600,000

1996 1997 1998 1999 2000 2001 2002

Adderall Adderall XR

$10,080$38,924

$78,591

$155,648

$238,001

0

100,000

200,000

300,000

400,000

500,000

600,000

1996 1997 1998 1999 2000 2001 2002

Adderall Adderall XR

Yearly Gross Sales Trends ($000’s)

$447,610

$513,791

Portfolio – Strong and ValuablePortfolio Portfolio –– Strong and ValuableStrong and Valuable

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DecisionMakers

20-50

Influencers 800-1000

Med Societies Patient Adv. Groups

27,000

Pediatric Patients

PediatricsSelect

Other…

NeurologyPsychiatry

Portfolio – Strong and ValuablePortfolio Portfolio –– Strong and ValuableStrong and Valuable

DTC/DTP Programs• 18% Rx growth

Targeted Field Force•High frequency on top doctors

•Focused message

Clinical•LADD-CAT

•386 Clinical Sites

Professional Education•800 National Faculty

•19,000 Education Exposures•67,000 Medical

Information Requests

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Portfolio Portfolio –– Strong and ValuableStrong and Valuable

Adult ADHDAdult ADHD

Estimated US patient population:Estimated US patient population:8.2 million of which 360,000 treated¹8.2 million of which 360,000 treated¹

Access to new target Physician AudienceAccess to new target Physician AudienceOverlaps with Bipolar Mood Disorder Audience (Efficient)Overlaps with Bipolar Mood Disorder Audience (Efficient)

Access to new patient poolAccess to new patient poolCurrently about 15% ofCurrently about 15% of AdderallAdderall XRXR RxsRxs

Exclusivity of Data for 3.5 years (WaxmanExclusivity of Data for 3.5 years (Waxman--Hatch)Hatch)Protection of new strengthsProtection of new strengths

Adolescent trial used forAdolescent trial used for pediatricpediatric exclusivity exclusivity

¹National Institute for Mental Health, 1999

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– Access MPH market segment (estimated ∼35% of Rx in 2005)– Differentiated formulation benefits (variable duration)– Emphasis on pediatric, utility in adult segments– Patented until 2018

MPH – Transdermal

– Novel mode of action– In proof of concept – Patented until 2015

SPD473

– Second entry non-stimulant– Phase III (results to be reported at Q4)– Utility in both pediatric and adult segments– Patented until 2015

SPD503 - Guanfacine

– Instant release

– Once daily formulation– Patented until 2018– ‘Gold standard’

– Access adult market– 3 years Hatch-Waxman exclusivity expected– Patented until 2018– Already double digit RX off label

– Augmented duration of effect

Adderall

Adderall XR Pediatric

Adderall XR Adult

SPD465

AMPH

ETAM

INE

NON-

STIM

ULA

NTS

MET

HYL

PH

ENID

ATE

Portfolio – Strong and ValuablePortfolio Portfolio –– Strong and ValuableStrong and Valuable

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Portfolio – Strong and Valuable - ADHD

1H 2H 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H

ADDERALL XR, PEDIATRIC

ADDERALL XR, ADULT

METHYPATCH

SPD503 / GUANFACINE

SPD465

SPD473

2003 2004 2005 2006 2007 2008

Estimated ADHD SubmissionsEstimated ADHD Submissions

Filing date to be confirmed

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Prevalence Diagnosed TreatedPrevalence Diagnosed Treated

Million

Epilepsy*

2.3 2.3

1.6

Bipolar Mood Disorder**

1.5

.75 .65

*Epilepsy Foundation of America

Bipolar Mood Disorder

Billion

June 2002-2003 2007 (est)

$1.9

$2.4

$ Market*

**Decision Resources Report on Bipolar 1 Mood Disorder: February 2003

SPD417 SPD417 -- BipolarBipolar

Portfolio Portfolio –– Strong and ValuableStrong and Valuable

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Portfolio – Strong and Valuable

SPD417 Bipolar

Rapidly Growing MarketHistorically unrecognized and under diagnosedDiagnosis rate is accelerating because of recognitionSeveral new product introductions

Many of which may be combined with and complementary to SPD417

Meeting the challenge with SPD417 Excellent mood stabilizer

30 year history of carbamazepine use in bipolarFirst and only carbamazepine indicated for bipolarUnique formulation with smooth coverageFavorable side effect profile (weight gain / cosmetic)

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Portfolio – Strong and Valuable

SPD417 Bipolar

Near-termPhase III trials in bipolar patients completedFiling date: H1 / 2004Ongoing market researchEligible for 3 years exclusivity under Hatch-Waxman

Formulation patent to 2011Additional exclusivity strategy

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GI GI –– Opportunities in IBDOpportunities in IBD

Inflammatory Bowel Disease in the United States

10%$ GrowthNovember 2002- October 2003

$677 Million

$ MarketNovember 2002-October 2003

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Portfolio – Strong and Valuable

Gastro Intestinal

Pentasa® (ulcerative colitis)Topical formulation delivers mesalamine throughout small and large bowel75% of Rx’s written for Crohn’s Disease (US) Topical formulation presents significant barrier to entry

Near-termDevelopment under way: 500 mg / double-strengthGreater convenience and compliancesNDA submission target: 2004

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Portfolio – Strong and Valuable

Gastro Intestinal

Mid-termSPD476: Ulcerative Colitis

Novel, high-dose matrix tablet form of mesalamine (improves compliance)Releases drug throughout colon and terminal ileum

Positive Phase II Study / Phase III ongoingNDA submission target: 2005Patent protection through 2020

SPD480: Ulcerative ProctitisFoam Aerosol (improves tolerability)

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End Stage Renal DiseaseMarket Profile

$242 Million(MAT Oct, 2003)

RenagelRenagel®® PhosLoPhosLo®®

OTC calciumOTC calcium

$800 MillionMarket Potential

$800 MillionMarket Potential

Renal – Fosrenol®

Fosrenol® - a unique phosphate binder

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Portfolio – Strong and Valuable

Renal

Fosrenol® (hyperphosphatemia in ESRD)> 1,750 patients treated, some for up to 4 yearsImproved binding capacity

Selective for phosphate ↓ pill burden / ↑ complianceChewable tablet reduces water intake

New clinical guidelines support adoptionAggressive phosphate reduction goalCalcium being restricted

“Approvable”No new issues raised by regulators (data provided)Continued confidence in safety

Patent protection through 2018

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Portfolio – Strong and Valuable

AnagrelideAgrylin®/US

Orphan exclusivity expires March 2004Pediatric exclusivity program ongoing (September 2004)Other defense strategies under investigation

Xagrid®/EUPositive CPMP opinionEU country approvals being pursued10-year orphan drug status from approval (2004)

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SHIREGROWTH OPPORTUNITY

SHIRESHIREGGROWTHROWTH OOPPORTUNITYPPORTUNITY

Specialty Business

HIGHLY SUCCESSFUL

BUSINESS MODEL

Portfolio

STRONGAND

VALUABLE

PipelineFlow

EXCELLENT GROWTH

POTENTIAL

PipelineFlow

EXCELLENT GROWTH

POTENTIAL

Strategic Development

AND OTHER OPPORTUNITIES

Financials

SUCCESSFUL RESULTS

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Pipeline Flow Pipeline Flow –– Excellent Growth PotentialExcellent Growth Potential

2003 2004 2005 2006 2007

Registration: Target Filing Dates (Shows Market Presence From Filing Date Onwards)

CNSAdderall XR PediatricAdderall XR AdultsCarbatrol EpilepsySPD417 BipolarMPH-TransdermalSPD503 (guanfacine)SPD473SPD465

GIPentasa 250 mgPentasa 500 mgSPD476 (tablet)SPD480 (foam)

NephrologyFosrenol

OtherAgrylinXagrid (EU)Agrylin Pediatric Exclusivity

Filing date to be confirmed

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SHIREGROWTH OPPORTUNITY

SHIRESHIREGGROWTHROWTH OOPPORTUNITYPPORTUNITY

Specialty Business

HIGHLY SUCCESSFUL

BUSINESS MODEL

Portfolio

STRONGAND

VALUABLE

PipelineFlow

EXCELLENT GROWTH

POTENTIAL

Strategic Development

AND OTHER OPPORTUNITIES

Strategic Development

AND OTHER OPPORTUNITIES

Financials

SUCCESSFUL RESULTS

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The challenges today…The challenges today…

1 – 10,000 screened compounds is approved by FDA*3 – 10 marketed products produce revenues that match R&D costs*Longer and more difficult approval process

26 new drugs approved by FDA in 2002*Average review time each of 17.8 months

Innovation is more difficult* 10 – 15 years average discovery to market timeUS$32 billion invested in 2002US$800 average per drug development

Generics = 50% of total prescriptions dispensed in 2002**

*PhRMA, **IMS Health

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Strategy Strategy –– our goalour goal

Select, protect and grow major franchisesStrong sales and marketing forceEstablished relationships with Med SocietiesDTC Advertising

Focus R&D on late-stage development / key franchisesPII & PIII of developmentFewer, less risky projects

Aggressive business developmentM&A and LicensingMarketed products with growth potentialStrong IP

Consolidation & restructuringIntegrated structureBetter communication = better results

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Strategy update Strategy update

VaccinesProgress with spin off opportunity – on scheduleExpressions of interest received

SPD754 / TroxatylIn discussion with potential partners – quid/royaltiesProcess complete by mid 2004

Early stage research closure completed in Q3 2003M&A enhancedStrong financial positionOrganizational restructuring and site consolidation on schedule

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Why is Shire a partner of choice?

Proven sales and marketing track recordShire’s portfolio achieved 5x original estimated sales

Excellent post-approval clinical strategyGlobal positioning‘Can do’ attitudeTeam spiritMinimum bureaucracy

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SHIREGROWTH OPPORTUNITY

SHIRESHIREGGROWTHROWTH OOPPORTUNITYPPORTUNITY

Specialty Business

HIGHLY SUCCESSFUL

BUSINESS MODEL

Portfolio

STRONGAND

VALUABLE

PipelineFlow

EXCELLENT GROWTH

POTENTIAL

Strategic Development

AND OTHER OPPORTUNITIES

Financials

SUCCESSFUL RESULTS

Financials

SUCCESSFUL RESULTS

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Financial Highlights Financial Highlights –– Q3 2003Q3 2003

Millions of USD, except per share amounts

Q3 2003Revenues 289.4

Operating income 88.8

Income before tax 89.8

Net income 64.6

EPS (diluted):Ordinary shares 12.8cADS 38.3c

+ 16%

+ 3%

+ 10%

+ 7%

+ 2%

Differential growth rates influenced by:

Closure of Early Stage Research and intangible write-downs

Decrease in interest rates/FX

Discontinued operations, tax,and equity method investees

Growth overQ3 2002

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Balance SheetBalance Sheet

* Cash, cash equivalents, and marketable securities

1,185

807

1,713

30.06.03

1,275

896

1,783

30.09.03

1,214

806

1,573

31.12.02

Gross cash*

Net cash

Net assets

Millions of USD

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Summary

Continuing strong financial performanceBroadening and strengthening ADHD franchisePipeline progressing:

4 products in Registration 3 projects in Phase III5 in Phase II Potential for 12 approvals in the 04-07 period

Strategy implementation,organizational restructuring and US site consolidation on schedule

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SHIREGROWTH OPPORTUNITY

SHIRESHIREGGROWTHROWTH OOPPORTUNITYPPORTUNITY

Specialty Business

HIGHLY SUCCESSFUL

BUSINESS MODEL

Portfolio

STRONGAND

VALUABLE

PipelineFlow

EXCELLENT GROWTH

POTENTIAL

Strategic Development

AND OTHER OPPORTUNITIES

Financials

SUCCESSFUL RESULTS