SG Cowen 23rd Annual Health Care Conference March 18, Shire Pharmaceuticals Group plc

Transcription

1 SG Cowen 23rd Annual Health Care Conference March 18, 2003 Shire Pharmaceuticals Group plc

2 THE SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements included herein 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 such risks or uncertainties materialize, 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 commercialization, patents, government regulation and approval, including but not limited to the expected product approval date of lanthanum carbonate (FOSRENOL ), the impact of competitive products, including but not limited to the impact of same on Shire s ADHD franchise, and other risks and uncertainties detailed from time to time in our filings, including the Annual Report filed on Form 10-K 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, Fluviral S/F, Fosrenol, Pacis, Pentasa, ProAmatine, Solaraze, Troxatyl, EnSoTrol, Microtrol, OptiScreen, ProScreen, Solutrol, and Xagrid. 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. MethyPatch is a trademark of Noven Pharmaceuticals. 2

3 Agenda Strong FY 2002 financial performance New CEO Announcement ADHD update R&D pipeline Summary 3

4 Financial Highlights FY 2002 Millions of USD, except per share amounts FY 02* Revenues 1,037.3 Operating income Income before tax Net income Most Recent 2002 Growth Guidance Mid to high teens growth 2002 Growth 22% EPS (diluted): Ordinary shares 49.0c ADS 147.1c Mid to high single digit growth 11%** * Results for all periods are restated for the OTC divestment, accounted for as a discontinued operation ** Growth calculation is based on a 2002 EPS number, which excludes the gain on the disposal of the OTC business (impact of 1.2c per ADS). The 2001 EPS number adds back the impact of the merger charges and stock compensation costs (impact of 108.6c per ADS in total) 4

5 Analysis of Revenues FY 2002 Millions of USD FY 02 FY 01 Growth (%) Product Sales United States International Royalties Licensing* Other** n/a Total Revenues 1, * 2001 figures include one-time milestones paid to Shire Laboratories ** 2001 figures include revenues from contract manufacturing. The facility has since been divested. 5

6 Product Sales FY 2002 Millions of USD CNS Franchise FY 02 FY 01 Growth (%) Adderall XR Adderall Adderall Brand Carbatrol Other Franchises FY 02 FY 01 Growth (%) Agrylin Pentasa ProAmatine

7 Royalty Income FY 2002 Millions of USD FY 02 Royalties Reported Growth (%) Underlying Growth (%)* 3TC Zeffix Other** Total * Underlying sales growth expressed in constant exchange rates ** Includes Reminyl 7

8 Financial Ratios FY 02 FY 01 Q4 02 Q4 01 COGS : Product sales Gross margin R&D : Revenues S,G&A (excl. D&A) : Product sales Operating margin Includes $121.3m inbiochem merger charges and $6.8m in stock option compensation charges 8

9 Balance Sheet Millions of USD Net assets 1,573 1,485 1,263 Net cash Gross cash* 1, * Cash, cash equivalents, and marketable securities 9

10 CEO announcement Matthew Emmens appointed Near 30 year pharmaceutical career Merck & Co. Astra Merck Merck KGaA 10

11 MethyPatch Acquisition Leverages Shire ADHD expertise and sales efforts Broadens and diversifies ADHD portfolio beyond Adderall XR Provides Shire access to: 53% of ADHD market* which currently uses methylphenidate The first once-daily ADHD product to use a transdermal delivery system * Source: IMS Monthly Data (January 2003) 11

12 Growing with the Market US ADHD Market Recent Trends* TRX Prescription Volume (000s) Total ADHD Market TRx Prescription Volume (000s) Adderall XR and atomoxetine /12/200 27/12/200 03/01/200 10/01/200 17/01/ /01/200 31/01/200 07/02/200 14/02/200 21/02/200 28/02/200 07/03/200 Week ADHD Market Adderall XR atomoxetine * Source: IMS Weekly Data 12

13 ADHD market share changes Changes from December 20, 2002 to March 7, 2003* RITALIN LA DESOXYN (Abbott) METHYLIN ER CYLERT FOCALIN METADATE ER DEXEDRINE TABLET RITALIN SR METHYLIN GENERIC PEMOLINE METHLYPHENIDATE SR DEXTROSTAT ADDERALL XR DEXTROAMPHETAMIN DEXEDRINE SPANSULE RITALIN METADATE CD TOTAL GENERIC METHLYPHENIDATE ADDERALL CONCERTA Atomoxetine Market share (week of March 7, 2003): 7.18% * Source: IMS Health -2.50% -2.00% -1.50% -1.00% -0.50% 0.00% 0.50% Market Share Change (%) 13

14 Intellectual Property Rights Legal suit launched against Barr Laboratories regarding ANDA filed against Adderall XR Shire intends to vigorously defend its intellectual property rights 14

15 R&D Pipeline* Therapeutic Area PC/Phase I Phase II and beyond Total CNS Anti-infectives Oncology GI Other Total Updates Discontinuations: SPD421, SPD452, SPD453 Additions: MethyPatch, SPD465, SPD483 * As of February 27,

16 Fosrenol Candidate product for hyperphosphataemia under regulatory review in EU and US EU Status: Additional data analysis required Based on existing studies and additional external expert report Likely that review period will extend into H US Status: Approvable letter received Shire initiating dialogue with FDA to agree balance between pre and post approval commitments Further updates when Shire can be more specific about timing, until then, US launch timing maintained as end

17 Additional Approvals / Regulatory Action 2003 Current Expectations Adderall XR Adult Indication Adderall XR Canada MethyPatch US Xagrid EU 17

18 Key R&D Project Progressions* Pre-clinical Phase 1 Phase 2 Phase 3 Filing FOSRENOL XAGRID (EU) METHYPATCH (ADHD) ADDERALL XR (Canada) ADDERALL XR (adult) CARBATROL (bipolar) 2004 SPD503 (ADHD) H TROXATYL (AML) H TROXATYL (pancreatic) H SPD476 (UC) H SPD480 (UC) 2006 SPD421 (epilepsy) SPD754 (HIV / AIDS) H SPD473 (ADHD) H SPD703 (S. Pneu) Sep SPD705 (P. Aeru) Apr 2002 TBD * Anticipated as of February 27,

19 Summary Strong financial performance Clarity on management succession ADHD market performance and broadened product portfolio Strong R&D pipeline increasing late stage visibility 19

20 Shire Pharmaceuticals Group plc