Merrill Lynch Healthcare Conference New York

Transcription

1 Merrill Lynch Healthcare Conference New York Matthew Emmens Chief Executive Officer February 3, 2004

2 A Strategic Review Today and Beyond Clear Strengths Highly successful business model Strong pipeline of high potential products Near and mid-term opportunities Protect and grow key franchises Clear Strategy Select, protect and grow major franchises Focus R&D on late-stage development / key franchises Aggressive business development Consolidation & restructuring 2

3 SHIRE GROWTHROWTH OPPORTUNITY Specialty Business Portfolio Pipeline Flow Strategic Development Financials HIGHLY HIGHLY SUCCESSFUL SUCCESSFUL BUSINESS BUSINESS MODEL MODEL STRONG AND VALUABLE EXCELLENT GROWTH POTENTIAL AND OTHER OPPORTUNITIES SUCCESSFUL RESULTS 3

4 Specialty Business Successful Model High Growth in Revenue & Profitability % CAGR MM$ % CAGR Net Sales Operating Income

5 SHIRE GROWTHROWTH OPPORTUNITY Specialty Business Portfolio Pipeline Flow Strategic Development Financials HIGHLY SUCCESSFUL BUSINESS MODEL STRONG STRONG AND AND VALUABLE VALUABLE EXCELLENT GROWTH POTENTIAL AND OTHER OPPORTUNITIES SUCCESSFUL RESULTS 5

6 Portfolio Strong and Valuable 2002 Product Sales & Royalties Total Revenue: $1.037 Billion Adderall 11% Adderall XR 31% ProAmatine 5% Pentasa 8% Carbatrol 4% Agrylin 12% Antivirals 16% Others 13% 6

7 Specialty Business Successful Model Therapeutic Areas of Focus CNS GI Renal M&A and Licensing Therapeutic Areas as above Other Therapeutic Areas in specialty model 7

8 Portfolio Strong and Valuable Adderall Family Yearly Gross Sales Trends ($000 s) 600,000 $513, ,000 $447, , ,000 $238, , ,000 $10,080 $38,924 $155,648 $78, Adderall Adderall XR 8

9 Portfolio Strong and Valuable Professional Education 800 National Faculty 19,000 Education Exposures 67,000 Medical Information Requests Decision Makers Targeted Field Force High frequency on top doctors Focused message Influencers Med Societies Patient Adv. Groups Pediatrics 27,000 Select Other Clinical LADD-CAT 386 Clinical Sites Psychiatry Neurology DTC/DTP Programs 18% Rx growth Pediatric Patients 9

10 Portfolio Strong and Valuable Adult ADHD Estimated US patient population: 8.2 million of which 360,000 treated¹ Access to new target Physician Audience Overlaps with Bipolar Mood Disorder Audience (Efficient) Access to new patient pool Currently about 15% of Adderall XR Rxs Exclusivity of Data for 3.5 years (Waxman-Hatch) Protection of new strengths Adolescent trial used for pediatric exclusivity ¹National Institute for Mental Health,

11 AMPHETAMINE Portfolio Strong and Valuable Adderall Instant release Adderall XR Pediatric Once daily formulation Patented until 2018 Gold standard Adderall XR Adult Access adult market 3 years Hatch-Waxman exclusivity expected Patented until 2018 Already double digit RX off label SPD465 Augmented duration of effect NON-STIMULANTS METHYLPHENIDATE MPH Transdermal SPD503 - Guanfacine SPD473 Access MPH market segment (estimated 35% of Rx in 2005) Differentiated formulation benefits (variable duration) Emphasis on pediatric, utility in adult segments Patented until 2018 Second entry non-stimulant Phase III (results to be reported at Q4) Utility in both pediatric and adult segments Patented until 2015 Novel mode of action In proof of concept Patented until

12 Portfolio Strong and Valuable - ADHD Estimated ADHD Submissions ADDERALL XR, PEDIATRIC 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H ADDERALL XR, ADULT METHYPATCH SPD503 / GUANFACINE SPD465 Filing date to be confirmed SPD473 12

13 Portfolio Strong and Valuable Million Epilepsy* Bipolar Mood Disorder** SPD417 - Bipolar Billion Bipolar Mood Disorder $ Market* $2.4 $ June (est) Prevalence Diagnosed Treated *Epilepsy Foundation of America **Decision Resources Report on Bipolar 1 Mood Disorder: February

14 Portfolio Strong and Valuable SPD417 Bipolar Rapidly Growing Market Historically unrecognized and under diagnosed Diagnosis rate is accelerating because of recognition Several new product introductions Many of which may be combined with and complementary to SPD417 Meeting the challenge with SPD417 Excellent mood stabilizer 30 year history of carbamazepine use in bipolar First and only carbamazepine indicated for bipolar Unique formulation with smooth coverage Favorable side effect profile (weight gain / cosmetic) 14

15 Portfolio Strong and Valuable SPD417 Bipolar Near-term Phase III trials in bipolar patients completed Filing date: H1 / 2004 Ongoing market research Eligible for 3 years exclusivity under Hatch-Waxman Formulation patent to 2011 Additional exclusivity strategy 15

16 GI Opportunities in IBD Inflammatory Bowel Disease in the United States $ Market November October 2003 $ Growth November October 2003 $677 Million 10% 16

17 Portfolio Strong and Valuable Gastro Intestinal Pentasa (ulcerative colitis) Topical formulation delivers mesalamine throughout small and large bowel 75% of Rx s written for Crohn s Disease (US) Topical formulation presents significant barrier to entry Near-term Development under way: 500 mg / double-strength Greater convenience and compliance snda submission target:

18 Portfolio Strong and Valuable Gastro Intestinal Mid-term SPD476: Ulcerative Colitis Novel, high-dose matrix tablet form of mesalamine (improves compliance) Releases drug throughout colon and terminal ileum Positive Phase II Study / Phase III ongoing NDA submission target: 2005 Patent protection through 2020 SPD480: Ulcerative Proctitis Foam Aerosol (improves tolerability) 18

19 Renal Fosrenol Fosrenol - a unique phosphate binder End Stage Renal Disease Market Profile Renagel PhosLo $800 Million Market Potential OTC calcium $242 Million (MAT Oct, 2003) 19

20 Portfolio Strong and Valuable Renal Fosrenol (hyperphosphatemia in ESRD) > 1,750 patients treated, some for up to 4 years Improved binding capacity Selective for phosphate pill burden / compliance Chewable tablet reduces water intake New clinical guidelines support adoption Aggressive phosphate reduction goal Calcium being restricted Approvable No new issues raised by regulators (data provided) Continued confidence in safety Patent protection through

21 Portfolio Strong and Valuable Anagrelide Agrylin /US Orphan exclusivity expires March 2004 Pediatric exclusivity program ongoing (September 2004) Other defense strategies under investigation Xagrid /EU Positive CPMP opinion EU country approvals being pursued 10-year orphan drug status from approval (2004) 21

22 SHIRE GROWTHROWTH OPPORTUNITY Specialty Business Portfolio Pipeline Flow Flow Strategic Development Financials HIGHLY SUCCESSFUL BUSINESS MODEL STRONG AND VALUABLE EXCELLENT EXCELLENT GROWTH GROWTH POTENTIAL POTENTIAL AND OTHER OPPORTUNITIES SUCCESSFUL RESULTS 22

23 Pipeline Flow Excellent Growth Potential Registration: Target Filing Dates (Shows Market Presence From Filing Date Onwards) CNS Adderall XR Pediatric Adderall XR Adults Carbatrol Epilepsy SPD417 Bipolar MPH-Transdermal SPD503 (guanfacine) SPD473 SPD465 GI Pentasa 250 mg Pentasa 500 mg SPD476 (tablet) SPD480 (foam) Filing date to be confirmed Nephrology Fosrenol Other Agrylin Xagrid (EU) Agrylin Pediatric Exclusivity 23

24 SHIRE GROWTHROWTH OPPORTUNITY Specialty Business Portfolio Pipeline Flow Strategic Development Financials HIGHLY SUCCESSFUL BUSINESS MODEL STRONG AND VALUABLE EXCELLENT GROWTH POTENTIAL AND AND OTHER OTHER OPPORTUNITIES OPPORTUNITIES SUCCESSFUL RESULTS 24

25 The challenges today 1 10,000 screened compounds is approved by FDA* 3 10 marketed products produce revenues that match R&D costs* Longer and more difficult approval process 26 new drugs approved by FDA in 2002* Average review time each of 17.8 months Innovation is more difficult* years average discovery to market time US$32 billion invested in 2002 US$800 average per drug development Generics = 50% of total prescriptions dispensed in 2002** *PhRMA, **IMS Health 25

26 Strategy our goal Select, protect and grow major franchises Strong sales and marketing force Established relationships with Med Societies DTC Advertising Focus R&D on late-stage development / key franchises PII & PIII of development Fewer, less risky projects Aggressive business development M&A and Licensing Marketed products with growth potential Strong IP Consolidation & restructuring Integrated structure Better communication = better results 26

27 Strategy update Vaccines Progress with spin off opportunity on schedule Expressions of interest received SPD754 / Troxatyl In discussion with potential partners quid/royalties Process complete by mid 2004 Early stage research closure completed in Q M&A enhanced Strong financial position Organizational restructuring and site consolidation on schedule 27

28 Why is Shire a partner of choice? Proven sales and marketing track record Shire s portfolio achieved 5x original estimated sales Excellent post-approval clinical strategy Global positioning Can do attitude Team spirit Minimum bureaucracy 28

29 SHIRE GROWTHROWTH OPPORTUNITY Specialty Business Portfolio Pipeline Flow Strategic Development Financials HIGHLY SUCCESSFUL BUSINESS MODEL STRONG AND VALUABLE EXCELLENT GROWTH POTENTIAL AND OTHER OPPORTUNITIES SUCCESSFUL SUCCESSFUL RESULTS RESULTS 29

30 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 30

31 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 31

32 Summary Continuing strong financial performance Broadening and strengthening ADHD franchise Pipeline progressing: 4 products in Registration 3 projects in Phase III 5 in Phase II Potential for 12 approvals in the period Strategy implementation,organizational restructuring and US site consolidation on schedule 32

33 SHIRE GROWTHROWTH OPPORTUNITY Specialty Business Portfolio Pipeline Flow Strategic Development Financials HIGHLY SUCCESSFUL BUSINESS MODEL STRONG AND VALUABLE EXCELLENT GROWTH POTENTIAL AND OTHER OPPORTUNITIES SUCCESSFUL RESULTS 33