Third Quarter Results ended 30 September...

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Third Quarter Resultsended 30 September 2002

Third Quarter Resultsended 30 September 2002

Shire Pharmaceuticals Group plcShire Pharmaceuticals Group plc

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Comment on the “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995

The statements made during today’s presentation, or in response to questions during the Question & Answer period, 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 that such risks or uncertainties materialise, 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 and commercialisation, the impact of competitive products, including but not limited to the impact of same on Shire’s ADHD franchise, patents, government regulation and approval, including but not limited to the expected approval date of lanthanum carbonate (Fosrenol/Fosnol) and other risks and uncertainties detailed from time to time in periodic reports produced by Shire, including the Annual Report filed on Form 10K by Shire with the Securities and Exchange Commission.

Trademark Information:Unless otherwise indicated, certain product names set out in this document are trademarks of the Shire Group, many of which are the subject of trademark registrations in certain territories. These names include, but are not limited to, Adderall, Adderall XR, Agrylin, Colazide, Carbatrol, DextroStat, Dirame, Fluviral S/F, Fosrenol, Foznol, MMX, Pacis, Pentasa, ProAmatine, Solaraze, Troxatyl, EnSoTrol, Microtrol, OptiScreen, ProScreen, and Solutrol. 3TC, Epivir, Combivir, Trizivir, and Zeffix are trademarks of GlaxoSmithKline. Reminyl and Concerta are trademarks of Johnson & Johnson. Aricept is a trademark of Pfizer / Eisai. Exelon is a trademark of Novartis.NeisVac-C is a trademark of Baxter International. Adept is a trademark of ML Laboratories.

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Agenda

Strategic Direction andSuccession Management Dr. James CavanaughThird Quarter 2002 Review Mr. Rolf StahelThird Quarter 2002 Financial Review Mr. Angus RussellNew Clinical Data Dr. Wilson TottenSummary Mr. Rolf StahelQuestion & Answer All

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Dr. James Cavanaugh - ChairmanDr. James Cavanaugh - Chairman


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Strategic Direction

Endorsed by the Board:To build a leading global specialty pharmaceutical CompanyAcquisition of companies or products and R&D development to match this strategyHeadquarters will continue to be in the UK; building leading positions in major markets

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Strategic Direction (Cont.)

Deep, capable, global management teamStrong, independent future:

Established marketingExperienced managementSound balance sheetStrong R&D pipeline

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Succession Management

Planning for the next 10 yearsShire in a strong positionMutual agreementRolf Stahel will continue as CEO to ensure a smooth transfer

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Rolf Stahel - Chief ExecutiveThird Quarter 2002 ReviewRolf Stahel - Chief ExecutiveThird Quarter 2002 Review


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Q3 2002 Highlights18% revenue and 8% EPS growth

ADDERALL XR – ADHD market dollar share at 29.1%*ADDERALL XR – ADHD Rx market share at 22.6%**

Strong clinical results to support:ADDERALL XRREMINYLFOSRENOL

Reiterate forecasts for full year 2002Mid to high double digit revenue growthMid to high single digit EPS growthOperating margin at upper end of 25 – 30% stated target range

Continued expectation of good growth in 2003

* Based on IMS gross sales data for latest available monthly period (September 2002)** Week ending October 25, 2002

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Financial Highlights – Q3 2002Millions of USD, except per share amounts

Revenues $256.3 + 18%Operating income $83.8 + 12%Income before tax $87.6 + 12%EPS (diluted):

Ordinary shares 12.4cADS 37.2c

Revenues $256.3 + 18%Operating income $83.8 + 12%Income before tax $87.6 + 12%EPS (diluted):

Ordinary shares 12.4cADS 37.2c

+ 8%

Q3 2001 34.4c

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Analysis of Revenues – Q3 2002Millions of USD

- 880.80.1Other

+ 18216.8256.3Total Revenues

- 220.90.7Licensing

+ 1537.843.5Royalties

+ 20177.3212.0Product Sales

% GrowthQ3 01Q3 02

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Key Product Sales – Q3 2002Millions of USD

+ 628.914.4PROAMATINE

+ 387.910.9CARBATROL

+ 820.021.6PENTASA

+ 4519.828.7AGRYLIN

+ 1186.796.1ADDERALL Brand

- 7986.718.1ADDERALL

n/a--78.0ADDERALL XR

% GrowthQ3 01Q3 02

US ADHD Market Share Changes*5 November 2001 to 25 October 2002

22.61%

11.11%

1.90% 2.34%

-2.84%

-10.10%

-26.55%

-30%-25%-20%-15%-10%

-5%0%5%

10%15%20%25%

AdderallXR

genericcopies ofAdderall

MetadateCD

Concerta All Others A/O MPH Adderall

Current Adderall market share = 5.60%(week ending 25 October 2002)

13* Source: IMS National Prescription Audit

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ADDERALL XR Switch Rate

0.0%10.0%

20.0%30.0%

40.0%50.0%

60.0%70.0%

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18Concerta Pooled (5 drugs)* ADDERALL XR (Actual)

Source: IMS National Prescription Audit* Pooled products are: Depakote ER, Effexor XR, Glucotrol XR, Tegretol XR and Wellbutrin XR

Comparison of months since launch

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US ADHD Rx Growth Rates2002 versus 2001 comparison

15,251

4,788

4,973

5,490

2001

14%17,370Sept YTD

17%5,592Q3

16%5,745Q2

10%6,033Q1

% Growth2002

* Source: IMS NPA, prescriptions in thousands

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US ADHD Growth Rates

38%Dollar Growth(September YTD*)

14%Rx Growth(September YTD*)

YTD 2002

Approximately $1.6 billion US ADHD market in 2002**

* Source: IMS Health, latest available monthly figures** Shire Estimate

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Business Development

Date Subject Details

Sept 13 2002 APS Acquisition Supports growth of future and current key franchise products

Oct 15 2002 UC Foam In-license Broadens project portfolio in the GI franchise

Oct 28 2002 Berna Alliance Broadens Shire’s vaccines platform into Europe

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Angus Russell - Group Finance DirectorThird Quarter 2002 Financial ReviewAngus Russell - Group Finance DirectorThird Quarter 2002 Financial Review


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Financial Highlights(before stock option compensation and one time charges)Millions of USD, except per share amounts

105.2c37.2c- ADS

+ 12

+ 12

+ 18

%

+20

+21

+ 23

%

35.1c

246.6

234.3

753.6

YTD 02Q3 02

EPS (diluted):12.4c- Ordinary shares

$ 87.6Income before tax

$ 83.8Operating income

$ 256.3Revenues

+8 +14

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Key Product Sales – Q3 2002Millions of USD

+ 5+ 387.910.9CARBATROL+ 16+ 628.914.4PROAMATINE

20.019.8

86.786.7

--

Q3 01

+ 3+ 23

- 3- 75n/a

US Scrip Growth %*

+ 8+ 45

+ 11- 79n/a

Growth %Q3 02

28.7AGRYLIN21.6PENTASA

96.1ADDERALL Brand18.1ADDERALL78.0ADDERALL XR

* Source: IMS Health

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Royalty Income – Q3 2002Millions of USD

----

+ 19

+ 6

Underlying Growth %*

+ 2865.5Other

Reported Growth %

Q3 02 Royalties

+ 1543.5Total

+ 175.5ZEFFIX

+ 332.53TC

* Underlying sales growth expressed in constant exchange rates, and excluding Emory settlement both in 2001 and 2002

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Financial Ratios – Q3 2002(before stock option compensation and one time charges)

32343133Operating margin

4118

8515

YTD 02

3719

8416

FY 01

3419

8515

Q3 01Q3 02

16R&D : Revenues40S,G&A (excl. D&A) :

Product sales

84Gross margin16COGS : Product sales

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Cash Flow – Q3 2002Millions of USD

Net cash surplus for Q3 2002 : $20m

Cash generation +$64m

Tax / interest-$20m

Products / equity investments-$4m

Fixed assets -$4m

Financing +$1m

-$17m Acquisitions

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Balance SheetMillions of USD

944

537

1,315

31.03.02

963

554

1,485

30.09.02

842940Gross cash*

435536Net cash

1,2631,421Net assets

31.12.0130.06.02

* Cash, cash equivalents, and marketable securities

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Future prospects – FY 2002 / 2003

Full year 2002 Reiterated Guidance

Revenue growth mid to high teens

EPS growth mid to high single digit

Operating margin upper end of 25% – 30%stated range target

Full year 2003

Good business growth expected, assuming:Anticipated continued success of ADDERALL XRLaunch and roll out of FOSRENOL in EU* and US*Growth from other significant sources of revenue

* Subject to regulatory approvals

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Wilson Totten – Group R&D DirectorNew Clinical DataWilson Totten – Group R&D DirectorNew Clinical Data


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Recent Clinical Presentations

Interim analysis of a 2 year Phase III study supports effectiveness and safety profile of Fosrenol. Data currently indicates a lower incidence of adverse events and suggest mortality trends favoring Fosrenol.(35th ASN Annual Meeting and Scientific Exposition, Philadelphia, USA)

FosrenolNov 2 2002

First long-term head to head study shows superiority ofReminyl over donepezil on Mini-Mental State Examination (MMSE) in patients with Alzheimer’s disease.(6th Congress of the EFNS, Vienna, Austria)

ReminylOct 29 2002

LADD-CAT shows “well-controlled” ADHD patients may do better on Adderall XR. Results of this 3,000 patient clinical experience trial showed significant improvement when children with ADHD, on regimens including short-acting MPH, short-acting Adderall or Concerta, were switched to AdderallXR. Benefit was evident at both 8 and 12 hours post dose. In addition parents and physicians were more satisfied and preferred Adderall XR over their previous treatment regime.(14th CHADD International Conference, Miami, USA)

Adderall XROct 17 2002

DetailsSubjectDate

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Baseline W eek 1 W eek 3 W eek 7*P<0.0001 vs Baseline; one sample t-test of mean change from baseline.†P<0.05 vs Baseline.

Mean 8-hour CGIS-P Total Scoresfor the ITT Population Receiving an Equivalent Dose of Adderall XR®**

Adderall® QD (n=275) Adderall® BID+ (n=561) MPH BID + QD (n=37) MPH TID + (n=10) Concerta® (n=195)

Mea

n C

GIS

-P T

otal

Sco

re

0

2

4

6

8

10

12

14

* * * * * ** * *† †

† ††

* 14th CHADD International Conference, Miami, USA** The CGI rating is performed by clinicians, and gives a global evaluation of clinical status over time

LADD-CAT: Trial of Adderall XR in “Well-Controlled” ADHD*

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0

2

4

6

8

10

12

14

® ®

* * * * * * * ** †† †

Mean 12-hour CGIS-P Total Scoresfor the ITT Population Receiving an Equivalent Dose of Adderall XR®**

B aseline W eek 1 W eek 3 W eek 7

*P<0.0001 vs Baseline; one sample t test of mean change from baseline.†P<0.05 vs Baseline.

Mea

n C

GIS

-P T

otal

Sco

re

* 14th CHADD International Conference, Miami, USA** The CGI rating is performed by clinicians, and gives a global evaluation of clinical status over time

LADD-CAT: Trial of Adderall XR in “Well-Controlled” ADHD*

Adderall® QD (n=275) Adderall® BID+ (n=554) MPH BID + QD (n=37) MPH TID + (n=10) Concerta® (n=195)

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REMINYL – EFNS*

Primary endpoint: Bristol Activities of Daily Living (BrADL)Reminyl and donepezil perform equally well

Secondary Endpoints: Mini-Mental State Examination (MMSE)Cognitive function and attention

Reminyl demonstrates signs of equivalent or superior benefit to donepezilPotential implication of nicotinic receptor action

* 6th Congress of the European Federation of Neurological Societies (EFNS), Vienna, Austria

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Reminyl demonstrates advantages in cognition (MMSE)**

-2.5-2

-1.5-1

-0.50

0.51

1.52

2.5M

ean

MM

SE (1

SE)

cha

nge

from

ba

selin

e

Reminyldonezepil

Impr

ovem

e nt

*p < 0.0001

*p = 0.0006*p < 0.0001

*p =0.0032

baseline 13 26 52Time (weeks)* vs. baseline

** MMSE: Mini-Mental State Examination, data presented at the 6th Congress of the EFNS, Vienna, Austria

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GAL-GBR-2 Dosage ITT pop

Number of pts staying on maximum dose at last visit (71.1% Gal, 69.2% Don)Continuation of study drug at end of 1 year(59% Gal, 57% Don)Completers (80.4% Gal, 78% Don)

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GAL-GBR-2 Adverse Events

(3.3%)

(13.2%)

(15.4%)

(19.8%)

(93.4%)

(2.1%)

(13.4%)

(17.5%)

(18.6%)

(90.7%)

* None in relationship to drug

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42

Number of AEsNumber of patients

AEs causing death*

1612

2113


AEs leading to withdrawal

3014

3517


Serious AEs

3218

2818


Severe AEs

45685

58888


All AEs

DonepezilGalantamine(Safety population)

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FOSRENOL

EUReview of submission continuesFOSRENOL EU launches 2003*

USReview of submission continuesFOSRENOL US launch 2003*

Active discussions ongoing with both regulatory authoritiesOpinion leader support remains strongStrong Phase III data on Fosrenol presented at 2002 ASN

* Subject to regulatory approval

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FOSRENOL – Study 307 (Interim Data)Phosphorus Control

* 35th ASN Annual Meeting and Scientific Exposition, Philadelphia, USA

FOSRENOL – Study 307 (Interim Data)Lanthanum

therapyConventional

therapy(n = 647) (n = 642)

Peripheral edema 13.3 23.2 9.9Dialysis graft complication 21.9 31 9.1Dyspnea 19.9 29 9.1Back pain 10.5 19.3 8.8Coughing 17 24.8 7.8Diarrhea 19.8 27.4 7.6Myalgia 18.1 25.5 7.4Hypotension 13.8 20.9 7.1Hypercalcemia 3.4 10.4 7Abdominal pain 14.1 20.9 6.8Influenza-like symptoms 12.5 19.2 6.7Pneumonia 6.5 13.2 6.7Edema 4 10.7 6.7Dyspepsia 8.2 14.8 6.6Dialysis graft occlusion 18.7 24.9 6.2Asthenia 7 13.1 6.1

Serious AEs (%)Renal transplant 6.5 9.2 2.7Dialysis graft occlusion 6.5 7.8 1.3Myocardial infarction 3.6 5.6 2Pneumonia 3.2 5.5 2.3Cardiac failure 3.2 5.8 2.6

Adverse event Difference

AEs ≥ 6% more prevalent in the conventional group than in the lanthanum group

* 35th ASN Annual Meeting and Scientific Exposition, Philadelphia, USA 36

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R&D Pipeline balance

Therapeutic Area PC/Phase I Phase II and beyond Total

CNS 4 3 7

Anti-infectives 6 1 7

Oncology 0 3 3

GI 0 4 4

Other 0 1 1

22 full development projects

221210Total

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Rolf Stahel – Chief ExecutiveSummaryRolf Stahel – Chief ExecutiveSummary


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Summary

Q3 2002:Revenues up 18%, EPS up 8%Good performance of ADDERALL brand

Strong clinical data to support products / projectsADDERALL XR (Ladd.cat*)REMINYL (1 year head to head study**)FOSRENOL (2 year study***)

2002 full year guidance reiterated2003 expectations of good growth reiterated

* 14th CHADD International Conference, Miami, USA** 6th Congress of the EFNS, Vienna, Austria*** 35th ASN Annual Meeting and Scientific Exposition, Philadelphia, USA

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Adderall XR® vs. Concerta®

3.48%

7.60%

10.22%12.57%

14.16%15.66% 16.61% 17.41%

18.58%20.21%

21.23%

1.30%

4.54%

7.36%9.71%

11.51%13.02%

14.57%16.01%

17.26%18.46%

20.00%

0%

5%

10%

15%

20%

25%

1 2 3 4 5 6 7 8 9 10 11

Adderall XR ConcertaSource: IMS NPAMonth 11 for Adderall XR is September ’02.Month 11 for Concerta is June ’01.

Monthly Market Share (comparable months post-launch)

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Back-up Slide

AWP Cost per DaySelected ADHD Products

$2.701.97$1.37Generic Adderall

$1.242.58$0.48Generic MPH

$3.042.00$1.52Adderall

$3.091.14$2.71Concerta

$3.181.27$2.50Adderall XR

Cost per Day (AWP)Tabs/DayCost/Tab (AWP)

Product

Sources: Cost/Tab – Price Alert September 2002Tabs/Day – IMS Basic Data Report 2Q ‘02

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LADD-CAT: Trial of Adderall XR in “Well-Controlled” ADHD

84.7% 87.7% 84.6%

0

20

40

60

80

100

MPH BID+QD MPH TID+ Concerta®Previous Medication

Perc

ent (

%)

New Medication (Adderall XR®) Previous Medication

Parent Satisfaction Questionnaire: “Overall, I am satisfied with my child taking this medication.”

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81%92.5% 86.5%

0

20

40

60

80

100


Perc

ent (

%)

New Medication (Adderall XR®) Previous Medication

Physician Satisfaction Questionnaire: “Overall, based on clinical observations, I am satisfied with this medication.”

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74.1%83.9%83.8%

0

20

40

60

80

100


Perc

ent (

%)

Prefer New Medication (Adderall XR®) Prefer Baseline Medication Equal Preference

Parent Preference Questionnaire: “Overall, which of the two medications do you prefer?”

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86.4% 92.7%77.8%

0

20

40

60

80

100


Perc

ent (

%)

Prefer New Medication (Adderall XR®) Prefer Baseline Medication Equal Preference

Physician Preference Questionnaire: “Overall, which of the two medications do you prefer?”

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Baseline (previous med) Week 1 Week 3 Week 7 (Adderall XR®)*P<0.0001 vs Baseline; one sample t-test of mean change from baseline.

02468

1012

8-hour CGIS-P (N=1078) 12-hour CGIS-P (N=1071)

Mea

n C

GIS

-P T

otal

Sco

re

* * ****


Mean 8-hour and 12-hr CGIS-P Total Scoresfor ITT Population Receiving an Equivalent Dose of Adderall XR®.

Data represent patients receiving a dose of Adderall XR® at Week 7 that was equivalent to their dose of baseline (previous) stimulant medication according to the dose conversion paradigm.Mean CGIS-P total scores for the ITT population revealed significant improvement (P<0.0001) at both 8 and 12 hours post dosewhen analyzed by gender, by age group (5-9 and 10-12 years of age), and by ADHD subtype.

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