Shire Pharmaceuticals Group plc

Transcription

1 Third Quarter Results Period ending 30 September November 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 forwardlooking statements involve a number of risks and uncertainties and are subject to change at any time. In the event 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 manufacturing and commercialisation, the impact of competitive products, including, but not limited to, the impact on Shire s Attention Deficit Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire s ADHD franchise, government regulation and approval, including but not limited to the expected product approval date of lanthanum carbonate (FOSRENOL ) and METHYPATCH, and other risks and uncertainties detailed from time to time in our filings, including the Annual Report filed on Form 10-K/A by Shire with the Securities and Exchange Commission. Trade mark Information: The following are trade marks of Shire or companies within the Shire Group, which are the subject of trade mark registrations in certain territories. ADDERALL XR (mixed amphetamine salts), ADDERALL (mixed amphetamine salts), AGRYLIN (anagrelide hydrochloride), AMATINE (midodrine hydrochloride), CALCICHEW (calcium carbonate), CARBATROL (carbamazepine), COLAZIDE (balsalazide), DEXTROSTAT (dextroamphetamine salt), EMUTROL, ENSOTROL, FARESTON (toremifene) FLUVIRAL S/F (split-virion influenza vaccine), FOSRENOL (lanthanum carbonate), METHYPATCH (methylphenidate), MICROTROL, MICROTROL DR, MICROTROL PR, MICROTROL XR, OPTISCREEN, PROAMATINE (midodrine hydrochloride), PROSCREEN, RAPITROL, SOLARAZE (diclofenac sodium 3%), SOLUTROL, TROXATYL (troxacitabine), XAGRID (anagrelide hydrochloride). The following are trade marks of third parties: 3TC (lamivudine) (trade mark of GlaxoSmithKline (GSK)), ADEPT (4% icodextrin solution) (trade mark of ML Laboratories plc), AZT (trade mark of GSK), BIO-HEP B (trade mark of Berna Biotech AG), COMBIVIR (trade mark of GSK), EPIVIR (trade mark of GSK), HEPAVAX GENE (trade mark of Berna Biotech AG), NEISVAC-C (trade mark of Baxter International Inc.), PENTASA (mesalamine) (trade mark of Ferring), REMINYL (galantamine hydrobromide) (trade mark of Johnson & Johnson), TRIZIVIR (trade mark of GSK), ZEFFIX (lamivudine) (trade mark of GSK), Concerta (trade mark of Johnson & Johnson), Metadate CD (trade mark of Celltech), Ritalin LA (trade mark of Novartis), Strattera (trade mark of Eli Lilly), Focalin (trade mark of Novartis), ASACOL (trade mark of Procter & Gamble). 2

3 Agenda Quarterly Highlights Matthew Emmens Third Quarter 2003 Financial Review Angus Russell ADHD Market Greg Flexter Outlook and Summary Matthew Emmens Questions & Answers All and Dr Wilson Totten 3

4 Matthew Emmens Chief Executive Quarterly Highlights Shire Pharmaceuticals Group plc

5 Financial Highlights Q Millions of USD, except per share amounts Q Revenues Operating income 88.8 Income before tax 89.8 Net income 64.6 Growth over Q % + 10% EPS (diluted): Ordinary shares 12.8c ADS 38.3c + 3% 5

6 Q Highlights Strong third quarter performance Adderall XR sales up 55% - record prescription levels Royalties up 14%, 3TC up 9%, others (mainly Reminyl) up 51% International division sales up 12% (outperforming market growth of approximately 8%*) On course to achieve year-end guidance Positive outlook for 2004 Business re-focused with new strategy Approvable letter for Adderall XR adult indication Progression in the pipeline *IMS Health data 6

7 Deep and broad ADHD portfolio AMPHETAMINE Adderall Adderall XR paediatric Adderall XR Adult SPD465 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 METHYLPHENIDATE NON-STIMULANTS METHYLPHENIDATE MPH Transdermal SPD503 - Guanfacine SPD473 Access MPH market segment ( 35% of Rx in 2005) Differentiated formulation benefits (variable duration) Emphasis on paediatric, utility in adult segments Patented until 2018 Non-stimulant Phase III (results to be reported at Q4) Utility in both paediatric and adult segments Patented until 2015 Novel mode of action In proof of concept Patented until

8 Building CNS franchise outwards Portfolio market presence from filing dates onwards ADHD 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H Adderall XR, Paediatric Adderall XR, Adult SPD465 Methylphenidate-Transdermal Filing date to be confirmed SPD503 - Guanfacine SPD473 Other CNS products Carbatrol, Epilepsy SPD417 - Bipolar = Amphetamine = Methylphenidate = Non-Scheduled 8

9 Gastrointestinal and Renal update SPD476 enters Phase III Fosrenol Targeted for Ulcerative Colitis Novel formulation of mesalamine High strength to improve compliance in long term therapy NDA filing 2005 Patented until 2020 Responses filed with the Reference Member State US responses to be submitted to the FDA by year-end Scheduled meeting with both agencies before year end Extensive clinical programme: 1700 patients including >40 patients at over 3 years 9

10 Strategy update Vaccines Progress with spin off opportunity Expressions of interest received SPD754 / Troxatyl In discussion with potential partners Process complete by mid 2004 Early stage research closure completed in Q3 M&A enhanced Organisational restructuring and site consolidation update to be provided at year-end 10

11 Angus Russell Group Finance Director Third Quarter 2003 Financial Review Shire Pharmaceuticals Group plc

12 Financial Highlights Q Millions of USD, except per share amounts Q Revenues Growth over Q % Differential growth rates influenced by: Operating income 88.8 Income before tax 89.8 Net income 64.6 EPS (diluted): Ordinary shares 12.8c ADS 38.3c + 10% + 7% + 2% + 3% Closure of Early Stage Research and intangible writedowns Decrease in interest rates/fx Discontinued operations, tax, and equity method investees 12

13 Financial Ratios Consistency of margins Lower S,G&A during the quarter Q3 03 (%) YTD 03 (%) Q2 03 (%) FY 02 (%) COGS : Product sales Gross margin R&D : Revenues S,G&A (excl. D&A) : Product sales Operating margin

14 Product Sales Q Millions of USD Q3 03 Q3 02 Growth (%) US Rx Growth (%)* Adderall XR Adderall Adderall franchise Agrylin Pentasa ProAmatine Carbatrol * Source: IMS Data 14

15 Royalty Income Q Millions of USD Q3 03 Q3 02 Reported Growth (%) 3TC * Zeffix ** Other*** Total *The impact of foreign exchange movements has contributed 3% to the reported growth ** The impact of foreign exchange movements has contributed 5% to the reported growth ***Includes mainly Reminyl 15

16 Cash Flow Q Millions of USD Cash generation + $133 - $23 -$11 - $10 Tax / interest Products / equity investments Fixed assets Net cash increase for Q : + $89M 16

17 Balance Sheet Millions of USD Net assets 1,783 1,713 1,573 Net cash Gross cash* 1,275 1,185 1,214 * Cash, cash equivalents, and marketable securities 17

18 FY 2003 Financial Outlook Full year 2003 Revenue growth Guidance Mid to high teens* Operating margin Circa 30%* EPS growth (per ADS) High single to low double digit Now including Early Stage Research closure cost impact of three cents *unchanged 18

19 Greg Flexter Senior VP of Marketing Shire US, Inc. Shire Pharmaceuticals Group plc

20 Commercial Highlights - ADHD Adderall XR Back-to-School performance Very strong Market share Holding well in rapidly growing market Adult ADHD A growth opportunity 20

21 Adderall XR vs. Total ADHD Market 2003 Back-to-School Prescription Growth % Growth in Weekly Prescription Volume (8/1/03 10/17/03) Total ADHD Market Adderall XR Rx Rx 650, , , , , , , , , , , % 97, % 90, , ,000 80,000 17/10/ /08/ /08/ /08/ /08/ /08/ /09/ /09/ /09/ /09/ /10/ /10/ /08/ /08/ /08/ /08/ /08/ /09/ /09/ /09/ /09/ /10/ /10/ /10/2003 SOURCE: IMS NPA Week ending 8/1/03 is last week before school started nationwide ,065

22 Adderall XR Number 1 Market Share With Targeted HVP s Product Market Share * Top 27,000 HVP's Adderall XR 25.84% Adderall /Adderall Generic 12.42% Concerta 24.61% Metadate CD 2.42% Ritalin LA 1.45% Strattera 16.21% Focalin 1.19% All Other 15.86% * High Volume Prescribers, IMS Exponent (8/03) (Top 27,000 Targets = 73% of Market Rx Volume) 22

23 Weekly ADHD Market Share 12/27/02 10/24/03 30% 28.0% CONCERTA ADDERALL XR STRATTERA 25% 20% (- 3.7%) 24.3% 23.7% 23.0% (- 0.7%) 15% 16.1% 10% ADHD MARKET GROWTH (YTD SEPT, 2003) 5% TRx = 18% $ = 41% 0% 27/12/ /01/ /01/ /02/ /02/ /03/ /03/ /04/ /04/ /05/ /05/ /05/ /06/ /06/ /07/ /07/ /08/ /08/ /09/ /09/ /10/ /10/

24 Adderall XR vs. Strattera Launch Comparisons Weekly Market Share (comparable 44 weeks post-launch) 22% 20% 18% 16% 14% 12% 10% 8% 6% 4% 2% Strattera Adderall XR 0% WEEKS Following First Rx Appearance SOURCE: IMS NPA Week 1 for Adderall XR is 10/26/01; Week 44 is 8/23/02 Week 1 for Strattera is 12/20/02; Week 44 is 10/17/03 24

25 Adult ADHD ADHD is a childhood-onset disorder that persists into adulthood More than 60% still suffer as adults Estimated U.S. adult ADHD prevalence = 8.2 MM (<5% treated) ADHD runs in families Key symptoms may change as patients age Hyperactivity tends to diminish Inattention and impulsivity persist Untreated adult ADHD can be devastating in all aspects of life functioning, such as: Academic/occupational achievement Health/injury Social functioning Substance abuse Criminal behaviour 25

26 Adult ADHD Keys to Development Awareness among adult patients and physicians Understand symptoms and serious consequences ADHD can be inherited, affecting multiple family members Referral to a physician for treatment Many patients already seeing physician for related problems Individual and family screening Differential diagnosis In-depth symptom history Common comorbidities (depression, anxiety, etc.) Proven treatments Adults can benefit from effective, long-acting therapy 26

27 Matthew Emmens Chief Executive Shire Pharmaceuticals Group plc

28 Outlook and Summary Strong financial performance Confidence in year-end guidance Positive outlook for 2004 Pipeline progressing - 4 in Registration: 3 in Phase III: 5 in Phase II Broadening and strengthening ADHD franchise Strategy implementation Organisational restructuring and US site consolidation: update at year-end 28

29 Shire Pharmaceuticals Group plc