JP Morgan H&Q Healthcare Conference January 7, Shire Pharmaceuticals Group plc

Transcription

1 JP Morgan H&Q Healthcare Conference January 7, 2003 Shire Pharmaceuticals Group plc

2 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.

3 Agenda Strategic Direction Financial Strength Revenue Drivers Leadership position in ADHD Competitive R&D pipeline Significant Events in 2003

4 Unique Strategy Functional Focus R&D Search Marketing Technology Focus Therapeutic Focus CNS Oncology Anti-Infectives GI Others Geographic Focus Customer Focus Specialty Doctors * No current presence Small Molecules Biologics Advanced Drug Delivery United States Germany United Kingdom France Italy Spain Canada Japan* 4

5 Financial Highlights 9 months 2002 YTD (before stock option compensation and one time charges) Millions of USD, except per share amounts Revenues Operating income Income before tax EPS (diluted): - Ordinary shares -ADS YTD c 105.2c %

6 Financial Ratios 9 months 2002 YTD (before stock option compensation and one time charges) YTD 02 Q3 02 Q3 01 FY 01 COGS : Product sales Gross margin R&D : Revenues S,G&A (excl. D&A) : Product sales Operating margin

7 Product Sales By Segment Millions of USD Q3 02 Q3 01 Growth Sept 02 Sept 01 Growth % YTD YTD % US International

8 Key Product Sales 9 months 2002 YTD Millions of USD Sept 02 YTD Sept 01 YTD Growth % US Scrip Growth %* AGRYLIN PENTASA CARBATROL PROAMATINE * Source: IMS Health

9 Royalty Income 9 months 2002 YTD Millions of USD Sept 02 YTD Royalties Reported Growth % Underlying Growth %* 3TC ZEFFIX Other Total * Underlying sales growth expressed in constant exchange rates, and excluding Emory settlement in both 2001 and 2002

10 Adderall Brand Performance Millions of USD Sept 02 YTD Sept 01 YTD Growth % US Scrip Growth %* ADDERALL XR n/a n/a ADDERALL ADDERALL Brand Rx Market Share (week ending December 20, 2002)* Adderall XR 24.3% Adderall 4.9% Combined Adderall Brand 29.2% Generic Copies 10.7% * Source: IMS Health

11 Weekly Market Share of US ADHD Market* Adderall Adderall XR Generics 35% 30% 25% 20% 15% 10% 5% 0% 26/10/01 26/11/01 26/12/01 26/01/02 26/02/02 26/03/02 26/04/02 26/05/02 26/06/02 26/07/02 26/08/02 26/09/02 26/10/02 26/11/02 Market Share * Source: IMS Health (weekly up to December 20, 2002) Generic Adderall includes Barr, Eon, Ranbaxy

12 Life Cycle Conversions (TRx)* 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% Lexapro Adderall XR Clarinex Paxil CR Percent Conversion to Next Generation Product 0.0% * Source: Bear Stearns Week of Launch Detrol LA Nexium Glucophage XR Glucovance

13 Competitive Strengths of Adderall Franchise >27 million prescriptions* Rapid onset Flexible dosing regimen Proven efficacy Good safety record Proven marketing * Source: IMS Health, January 1996 to November 2002

14 Future Management of Adderall Franchise Broaden IP protection for Adderall XR* Adderall XR / Adderall Brand Life Cycle Management* Global ADHD strategy SPD473, SPD503 Progress from broader R&D pipeline** M&A*** *Commercially sensitive, no further details released ** Does not directly relate to the Adderall franchise *** May or may not relate to the ADHD franchise

15 US ADHD Population Incidence by Age Millions of Patients Prevalence Treated 0.0 Ages 6-18 Ages 18+ * Prevalence data calculated from data presented from Barkley, 1998 Data regarding adult and < 5 YOA is extrapolated data ** 2002 Adderall XR ATU Study

16 FOSRENOL EU US Review of submission continues FOSRENOL EU launches 2003* Review of submission continues FOSRENOL US launch 2003* Active discussions ongoing with both regulatory authorities Opinion leader support remains strong Strong Phase III data on Fosrenol presented at 2002 ASN * Subject to regulatory approval

17 FOSRENOL 2 year study (Interim data)* Phosphorus Control * 35 th ASN Annual Meeting and Scientific Exposition, Philadelphia, USA

18 FOSRENOL 2 year study (Interim data)* Adverse event Lanthanum therapy Conventional therapy Difference (n = 647) (n = 642) AEs 6% more prevalent in the conventional group than in the lanthanum group Peripheral edema Dialysis graft complication Dyspnea Back pain Coughing Diarrhea Myalgia Hypotension Hypercalcemia Abdominal pain Influenza-like symptoms Pneumonia Edema Dyspepsia Dialysis graft occlusion Asthenia Serious AEs (%) Renal transplant Dialysis graft occlusion Myocardial infarction Pneumonia Cardiac failure * 35 th ASN Annual Meeting and Scientific Exposition, Philadelphia, USA 18

19 Shire s Strong R&D Pipeline vs. Competition* 22 4 ** Pipeline by Company PC PII PI PIII Shire Merck KGaA 2 8 Allergan Forest Elan Recordati Lundbeck Novo Altana Orion Galen UCB * Source: Goldman Sachs as per September 2002 ** includes 2 projects in the registration phase Alcon King Medicis 1 1

20 Shire s Strong Pipeline vs. Competition* 42.0 Weighted Pipeline Index by Company ** Merck KGaA Shire Forest Elan Allergan Recordati Novo Orion Lundbeck * Source: Goldman Sachs as per September 2002 * * Weighting: PC = 0.1, PI = 1, PII = 2, PIII = Altana UCB Galen King Alcon Medicis

21 Major 2003 Expectations* Prove Shire strength in ADHD market Fosrenol regulatory status Management succession Significant advances in R&D projects * Not listed chronologically

22 Summary Clear strategic direction Strong financial position Robust product and royalty portfolio Leadership position in ADHD Clinical news flow to support products / projects Competitive R&D pipeline

23 Shire Pharmaceuticals Group plc