Shire Pharmaceuticals Group plc Shire Pharmaceuticals Group plc 1 - - PowerPoint PPT Presentation

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Second Quarter Results ended 30 June 2002 Second Quarter Results ended 30 June 2002

Shire Pharmaceuticals Group plc Shire 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 some of Shire’s ADHD franchise of which estimated forecast are speculative and should be read accordingly, patents, government regulation and approval, 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

Second Quarter 2002 Rolf Stahel Review Second Quarter 2002 Angus Russell Financial Review R&D Review Wilson Totten Summary Rolf Stahel Question & Answer All Second Quarter 2002 Rolf Stahel Review Second Quarter 2002 Angus Russell Financial Review R&D Review Wilson Totten Summary Rolf Stahel Question & Answer All

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Rolf Stahel - Chief Executive Second Quarter 2002 Review Rolf Stahel - Chief Executive Second Quarter 2002 Review

Shire Pharmaceuticals Group plc Shire Pharmaceuticals Group plc

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Q2 2002 Highlights

22% revenues and 9% EPS growth*

US ADHD $ market growth 42% YTD**

ADDERALL brand revenue up 50% in Q2***

Good progress with REMINYL

In-licensed mesalazine MMX and SOLARAZE Further upgrading on forecasts for the year

On track to deliver revenues of $1billion for 2002

* before stock option compensation and one time exceptional charges ** For period 1 January 02 to 31 May 02 *** May 2001 one tier pricing, Q2 02 launch of 2 new strengths plus price increase of 6% for Adderall and Adderall XR

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Financial Highlights – Q2 2002 Financial Highlights – Q2 2002

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

+ 9% Revenues $254.1 + 22% Operating income $77.7 + 19% Income before tax $81.7 + 16% EPS (diluted): Ordinary shares 11.6c ADS 34.9c Revenues $254.1 + 22% Operating income $77.7 + 19% Income before tax $81.7 + 16% EPS (diluted): Ordinary shares 11.6c ADS 34.9c

Q2 2001 31.7c

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Key Product Sales – Q2 2002

Millions of USD

+ 3 10.5 10.9 PROAMATINE + 27 9.9 12.6 CARBATROL + 13 19.1 21.5 PENTASA + 14 25.8 29.4 AGRYLIN + 50 69.4 104.1 ADDERALL Brand

• 59

69.4 28.3 ADDERALL n/a

• 75.8

ADDERALL XR % Growth Q2 01 Q2 02

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Royalty Income – Q2 2002

Millions of USD

• +16

+4 Underlying Growth %* +76 5.3 Other Reported Growth % Q2 02 Royalties +3 40.5 Total +2 4.5 ZEFFIX

• 3

30.7 3TC

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

18.97% 11.94% 1.76% 0.67%

• 0.92%
• 7.59%
• 24.83%
• 25%
• 20%
• 15%
• 10%
• 5%

0% 5% 10% 15% 20%

Adderall XR 3 generic copies of Adderall Metadate CD Concerta All Others A/O MPH Adderall

Source: IMS National Prescription Audit

US ADHD Market Share Changes US ADHD Market Share Changes

5 November 2001 to 19 July 2002 5 November 2001 to 19 July 2002

Current ADHD market share = 7.31% (week ending 19 July 2002) Share of Shire June revenue = 9.8%

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10.0 11.0 12.0 13.0 14.0 15.0 16.0 Dec-07 Dec-21 Jan-04 Jan-18 Feb-01 Feb-15 Mar-01 Mar-15 Mar-29 Apr-12 Apr-26 May-10 May-24 Jun-07 Jun-21

New Prescription Share

REMINYL: US Weekly NRx Share*

Source: IMS Weekly (National) Market defined as USC5=20400 * up until 28 June 2002

% 10

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1000 2000 3000 4000 5000 6000 7000 8000 9000 1 2 3 4 5 6 7 8 9 10 11 12

8-weekly periods ending 5 July 2002

Rx

Rem inyl Ar icept Exelon

All Products Launch Aligned - Retail Prescriptions*

REMINYL: UK Market

* Source: Scripcount plus

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FOSRENOL FOSRENOL

EU

Substantial additional, supportive data filed with “Rapporteur” Country during May – June 2002 Review of all sections of submission in progress Fosrenol first EU launches early 2003*

US

FDA has accepted FOSRENOL dossier – expected first response by H2 2003

* Subject to regulatory approval / acceptance

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MMX (Technology) – Ulcerative Colitis MMX (Technology) – Ulcerative Colitis

Proprietary system for targeting mesalamine (5-amino salicylic acid) to the bowel Low number of tablets per day Has potential to become substantially bigger than Pentasa Currently in Phase II development Rights in-licensed May 2002 for US, Canada, EU* and Japan

* Excluding Italy

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Angus Russell - Group Finance Director Second Quarter 2002 Financial Review Angus Russell - Group Finance Director Second Quarter 2002 Financial Review

Shire Pharmaceuticals Group plc Shire Pharmaceuticals Group plc

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Financial Highlights

(before stock option compensation and one time exceptional charges)

Millions of USD, except per share amounts

67.8c 34.9c

• ADS

+16 +19 +22 % +24 +26 +26 % 22.6c 158.9 150.3 497.3 YTD 02 Q2 02 EPS (diluted): 11.6c

• Ordinary shares

$81.7 Income before tax $77.7 Operating income $254.1 Revenues

+9 +17

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Key Product Sales – Q2 2002

Millions of USD

+10 +27 9.9 12.6 CARBATROL +15 +3 10.5 10.9 PROAMATINE 19.1 25.8 69.4 69.4

• Q2 01

+8 +24

• 7
• 64

n/a US Scrip Growth % +13 +14 +50

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n/a Growth % Q2 02 29.4 AGRYLIN 21.5 PENTASA 104.1 ADDERALL Brand 28.3 ADDERALL 75.8 ADDERALL XR

* Source: IMS Health

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Financial Ratios – Q2 2002

(before stock option compensation and one time exceptional charges) 32 31 30 31 Operating margin 42 20 87 13 Q1 02 37 19 84 16 FY 01 38 20 84 16 Q2 01 Q2 02 18 R&D : Revenues 40 S,G&A (excl. D&A) : Product sales 85 Gross margin 15 COGS : Product sales

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Cash Flow – Q2 2002 Cash Flow – Q2 2002

Millions of USD

• $20m Products / equity investments

Cash generation +$40m Financing +$3m

• $18m Tax / interest
• $5m Fixed assets

Net cash surplus for Q2 2002 : $nil

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Balance Sheet Balance Sheet

Millions of USD

842 944 940 Gross cash* 435 537 536 Net cash 1,263 1,315 1,421 Net assets 31.12.01 31.03.02 30.06.02

* Cash, cash equivalents, and marketable securities

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Future prospects – FY 2002 / 2003 Future prospects – FY 2002 / 2003

Full year 2002 New Guidance (Q2) Previous Guidance (Q1) Revenue growth mid to high teens low to mid teens EPS mid to high single equivalent to FY2001, digit growth potential for some growth Operating margin upper end of 25% – 30% upper end of 25%-30% stated range target stated range target Full year 2003 Good business growth expected, assuming: Anticipated continued success of ADDERALL XR Launch and roll out of FOSRENOL in EU* and US* Growth from other significant sources of revenue Full year 2002 New Guidance (Q2) Previous Guidance (Q1) Revenue growth mid to high teens low to mid teens EPS mid to high single equivalent to FY2001, digit growth potential for some growth Operating margin upper end of 25% – 30% upper end of 25%-30% stated range target stated range target Full year 2003 Good business growth expected, assuming: Anticipated continued success of ADDERALL XR Launch and roll out of FOSRENOL in EU* and US* Growth from other significant sources of revenue

* Subject to regulatory approvals

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Dr Wilson Totten – Group R&D Director R&D Review Dr Wilson Totten – Group R&D Director R&D Review

Shire Pharmaceuticals Group plc Shire Pharmaceuticals Group plc

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Balanced Pipeline Balanced Pipeline

Therapeutic Area PC/Phase I Phase II or beyond Total CNS 4 4 8 Oncology 3 3 Anti-infectives 6 1 7 Other 4 4 Total 10 12 22 Therapeutic Area PC/Phase I Phase II or beyond Total CNS 4 4 8 Oncology 3 3 Anti-infectives 6 1 7 Other 4 4 Total 10 12 22 Changes: Added Additional Phase II project for IBD No further development spend on Dirame SPD420 (ADHD, Cortex) option not exercised

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DIRAME

Emerging profile: Acute severe pain indications (eg cancer) with low constipation Peak sales potential reduced to $ 30 – 60 m* Decision; no further internal funding Project available for outsourcing

* Considered too low for expected size of company at time of launch

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FOSRENOL

First EU launches early 2003

Based on assumed approval Q3 2002 Substantial new data submitted

Comparison of available patient data

466 846 1707 (237.7) Now 142 410 1016 (147.1) March 2001 (EU Filing) >12 months >6 months Total n

(mean exposure in days)

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FOSRENOL: Recent Data Updates

Renal Osteodystrophy Study (biopsy) Presented at Oviedo June 2002, and EDTA July 2002 No evidence of bone toxicity over 12 months therapy EU Phase III Efficacy Presented at EDTA Copenhagen, July 2002 Sustained reduction in phosphate over 6 months Significantly lower incidence of hypercalcaemic episodes Long term comparative safety (outcomes) To be presented at ASN, November 2002

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FOSRENOL: Study 301 (EU Phase III)

Summary

Large multicentre randomised comparison with calcium carbonate 509 La patients, 257 Ca patients 6 months duration Equivalent phosphate control from week 9 onwards Dramatically reduced hypercalcaemia in lanthanum group Hypercalcemic events p < 0.001 in favour of lanthanum Excellent safety profile

10 20 30 40 50 60 70 80 2 3 4 5 6 10 14 18 22 26 Lanthanum Calcium

EU Phase III study Percentage of patients with PO4 ≤1.8mmol/L %

Titration Phase Maintenance Phase

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Week no.

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REMINYL – ALZHEIMER’S DISEASE REMINYL – ALZHEIMER’S DISEASE

J&J presented 36 months data on REMINYL at the APA*

Cognitive benefits sustained for up to three years At three years 53% of Reminyl patients declined by 10 points or less

• n the ADAS-cog (half of what is historically predicted for untreated

patients)

Estimated that cognitive decline in Reminyl-treated patients was delayed by an average of 18 months

17.8% had yet to drop significantly below baseline

* American Psychiatry Association May 2002

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ADDERALL XR: Adult Indication

Pivotal efficacy study now complete and analysed Results strongly positive Effect size consistent with other Adderall XR studies NDA filing date brought forward to end 2002 Previously Q1/2 2003

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News Flow – H2 2002 News Flow – H2 2002

Project Indication Event FOSRENOL Hyperphosphataemia Expected response in ESRD from EU RMS FOSRENOL Hyperphosphataemia Publications at ASN, in ESRD November 1 – 4, Philadelphia Adderall XR Adult indication US filing end 2002 SPD 473 Parkinson’s disease ‘Go – no go decision’ for PD and depression SPD 754 HIV / AIDS Enters Phase II New Project(s) Candidate drugs from research programs Project Indication Event FOSRENOL Hyperphosphataemia Expected response in ESRD from EU RMS FOSRENOL Hyperphosphataemia Publications at ASN, in ESRD November 1 – 4, Philadelphia Adderall XR Adult indication US filing end 2002 SPD 473 Parkinson’s disease ‘Go – no go decision’ for PD and depression SPD 754 HIV / AIDS Enters Phase II New Project(s) Candidate drugs from research programs

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Rolf Stahel – Chief Executive Summary Rolf Stahel – Chief Executive Summary

Shire Pharmaceuticals Group plc Shire Pharmaceuticals Group plc

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Summary Summary

Q2 2002:

Revenues up 22%, EPS up 9%* Good performance of Adderall brand Reminyl good progress MMX and Solaraze in-licensed

2002 full year outlook:

Revenues – mid to high teens growth (2002E: $1 billion) EPS – mid to high single digit growth Prospect for excellent Adderall brand progress Fosrenol first EU launches early 2003**

Q2 2002:

Revenues up 22%, EPS up 9%* Good performance of Adderall brand Reminyl good progress MMX and Solaraze in-licensed

2002 full year outlook:

Revenues – mid to high teens growth (2002E: $1 billion) EPS – mid to high single digit growth Prospect for excellent Adderall brand progress Fosrenol first EU launches early 2003**

* Before stock option compensation and one time exceptional charges ** Subject to regulatory approval / acceptance

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Shire Pharmaceuticals Group plc Shire Pharmaceuticals Group plc

5 10 15 20 25 1996 1997 1998 1999 2000 2001 $0 $200 $400 $600 $800 $1,000 $1,200

Prescriptions (Millions) Millions of USD *Source: IMS National Prescription Audit and RPP

2001 US ADHD Market Growth* 2001 US ADHD Market Growth*

2002 YTD ADHD Prescriptions (1 Jan to 30 June): 11.8 million + 13% ADHD Dollars (1 Jan to 31 May): $570.5 million + 42% ADHD Dollars May $105.4 million + 24%

2001: 8% Prescription Growth, 61% Dollar growth 2001: 8% Prescription Growth, 61% Dollar growth

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US ADHD Market: Once - Daily Segment US ADHD Market: Once - Daily Segment

Market Share: August 2000 to June 2002 Market Share: August 2000 to June 2002

0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Aug-00 Oct-00 Dec-00 Feb-01 Apr-01 Jun-01 Aug-01 Oct-01 Dec-01 Feb-02 Apr-02 Jun-02

Source: IMS National Prescription Audit * Trademark of Johnson & Johnson

Launch of Concerta* (MPH QD) Launch of ADDERALL XR (AMPH QD) % Once-Daily share of ADHD Market

0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% 26/10/2001 16/11/2001 07/12/2001 04/01/2002 25/01/2002 15/02/2002 08/03/2002 29/03/2002 19/04/2002 10/05/2002 31/05/2002 21/06/2002 12/07/202 Adderall XR three generics

Launch Comparison Launch Comparison

ADDERALL XR vs. generic ADDERALL ADDERALL XR vs. generic ADDERALL

Source: IMS National Prescription Audit up to week ending 19 July 2002

ADHD Market Share

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100000 200000 300000 400000 500000 600000 Week 1 Week 7 Week 13 Week 19 Week 25 Week 31 Week 37 Week 43 Week 49 2001 2002

Source: IMS National Prescription Audit

US ADHD Market: School Holiday Impact US ADHD Market: School Holiday Impact

Week 27 (for 02: July 1 – 5) Number of Prescriptions

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