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Matthew EmmensChief Executive Officer
February 3, 2004
Merrill Lynch Healthcare Conference
New York
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
3
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
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
5
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
6
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
7
Specialty Business Specialty Business –– Successful ModelSuccessful Model
Therapeutic Areas of Focus
CNSGIRenalM&A and Licensing
Therapeutic Areas as aboveOther Therapeutic Areas in “specialty” model
8
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
9
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
10
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
11
– 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
12
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
13
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
14
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)
15
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
16
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
17
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
18
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)
19
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
20
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
21
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)
22
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
23
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
24
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
25
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
26
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
27
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
28
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
29
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
30
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
31
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
32
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
33
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