Shire plc: PharmaVitae Profile

Shire plc: PharmaVitae Profile
CHAPTER 1 ABOUT THIS PROFILE 2

Executive summary 2

Quarterly news update 2

Company introduction 2

Company sales 2

Company financials 2

Key products and competitors 3

Data sourcing 3

Sales data 3

Analyst consensus 3

CHAPTER 2 EXECUTIVE SUMMARY 4

Key findings 4

Prescription pharmaceutical sales performance, 2001-13 5

Financial performance, 2001-13 6

Shire: PharmaVitae forecasts at a glance 7

Strategic insight 8

1) Shire's ADHD franchise growth 9

Shire becomes ADHD market-leader driven by Adderall XR growth 9

2) Corporate restructuring: growth via M&A 10

3) Returns from M&A anticpated out to 2013 11

Rx revenue growth to 2013 will be determined by Shire's acquired portfolios 11

SWOT analysis 12

Strengths 12

Weaknesses 13

Opportunities 14

Threats 15

CHAPTER 3 QUARTERLY NEWS UPDATE 19

Quarterly sales update, Q408 19

Product developments 21

Deals and alliances 22

Product deals 22

Technology deals 23

M&A activity 23

Company announcements 24

Future product milestones 25

CHAPTER 4 COMPANY INTRODUCTION 26

Key findings 26

Background 27

Key corporate developments 27

M&A history 28

Acquisition of Imperial Pharmaceutical Services 28

Acquisition of Phamavene 29

Acquisition of Richwood 29

Merger with Roberts Pharmaceutical Corporation 29

Acquisition of Fuisz Technologies' EU susidiaries 29

Acquisition of BioChem Pharma 29

Acquisition of Atlantic Pharmaceutical 30

Divestment of OTC products 30

Divestment of vaccines business 30

Acquisition of Transkaryotic Therapies 30

Acquisition of New River Pharmaceuticals 31

Divestment of non-core products 31

Acquisition of Jerini 31

Current corporate structure 32

Human Genetic Therapies 32

CHAPTER 5 COMPANY SALES 33

Key findings 33

Prescription pharmaceutical sales and growth rate analysis, 2001-13 34

Product analysis 36

Product analysis, 2001-07 36

Product analysis, 2007-13 40

Therapy area analysis 45

Therapy area analysis, 2001-07 46

Therapy area analysis, 2001-07 46

Therapy area analysis, 2007-13 48

Therapy area focus, 2001-13 51

Geographic analysis 53

Geographic analysis, 2001-07 54

Geographic analysis, 2007-13 58

Geographic focus, 2001-13 62

Launch/core/expiry analysis 64

Explanation of launch/core/expiry analysis 64

Launch analysis, 2007-13 65

Core analysis, 2007-13 70

Expiry analysis, 2007-13 71

Launch/core/expiry configuration, 2007-13 72

Molecule type analysis 73

Molecule type analysis, 2001-07 74

Molecule type analysis, 2007-13 75

Externalization analysis 78

Externalization analysis, 2001-07 79

Externalization analysis, 2007-13 81

CHAPTER 6 COMPANY FINANCIALS 84

Key findings 84

Reconciliation between PharmaVitae-formatted prescription pharma sales and company-reported total sales, 2001-07 85

Financial statements, 2001-07 87

Profit and loss account, 2001-07 87

Balance sheet, 2001-07 89

Operating costs and profit analysis 92

Operating costs and profit analysis, 2001-07 93

Operating cost ratio and profit margin analysis, 2001-07 95

Operating cost ratio and profit margin analysis, 2007-13 97

Operating costs and profit analysis, 2007-13 100

Return on capital employed analysis 101

Capital employed analysis, 2001-07 102

Return on capital employed (RoCE) analysis, 2001-07 104

CHAPTER 7 KEY PRODUCTS AND COMPETITORS 107

Key findings 107

Overview 108

Central nervous system 109

Vyvanse 109

Overview 109

Sales forecast 110

Intuniv 112

Overview 112

Sales forecast 113

Daytrana 116

Overview 116

Sales forecast 117

Adderall XR 118

Overview 118

Sales forecast 119

Adderall 122

Overview 122

Sales forecast 123

Endocrine, metabolic and genetic disorders 125

Elaprase 125

Overview 125

Sales forecast 126

Replagal 128

Overview 128

Sales forecast 129

GA-GCB 131

Shire is developing a human recombinant glucocerebrosidase enzyme replacement therapy, velaglucerase alfa (GA-GCB), for the potential treatment of Type I Gaucher disease. A second Phase III trial was initiated in January 2008 and completed enrollment the following July. Shire has stated its intention to make global filings in the second half of 2009, with launch in both the EU and the US in 2010. 131

Overview 131

Sales forecast 132

Gastroenterology 134

Lialda 134

Shire launched Lialda, a multimatrix (MMX), sustained-release formulation of mesalazine, in the US market in March 2007. It is indicated for the treatment of mild-to-moderate ulcerative colitis, and is a follow-on formulation of Shire's existing gastroenterology offering, Pentasa. It also reached several EU markets in 2008, including Germany, Ireland and the UK (under the brand name Mezavant). 134

Having achieved strong initial uptake, garnering $51m in its first (non-complete) year, Lialda is forecast strong sales growth over 2007-13, at +$480m. Growth will be driven by the continued roll out in further EU and RoW markets. 134

Overview 134

Sales forecast 135

Pentasa 137

Overview 137

Sales forecast 138

Urology and gender specific health 140

Fosrenol 140

Overview 140

Sales forecast 141

Immunology and inflammation 143

Firazyr 143

Overview 143

Sales forecast 144

CHAPTER 8 APPENDIX 146

R&D pipeline 146

References 147

Abbreviations 148

List of Tables

Table 1: Shire - PharmaVitae forecasts at a glance 7

Table 2: Shire quarterly global sales update ($m), Q4 2008 19

Table 3: Shire key product developments, 2008 21

Table 4: Shire product deals and alliances, 2008 22

Table 5: Shire technology deals and alliances, 2008 23

Table 6: Shire M&A activity, 2008 23

Table 7: Shire company announcements, 2008 24

Table 8: Shire future product milestones, 2008-10 25

Table 9: Shire product portfolio overview ($m), 2001-07 36

Table 10: Shire product portfolio overview ($m), 2007-13 40

Table 11: Shire product portfolio overview ($m), 2001-07 46

Table 12: Shire product portfolio overview ($m), 2007-13 48

Table 13: Shire portfolio overview by geographic region ($m), 2001-07 54

Table 14: Shire portfolio overview by geographic region ($m), 2007-13 58

Table 15: Shire launch portfolio overview ($m), 2007-13 65

Table 16: Shire core portfolio overview ($m), 2007-13 70

Table 17: Shire expiry portfolio overview ($m), 2007-13 71

Table 18: Shire portfolio overview by molecule type ($m), 2001-07 74

Table 19: Shire product portfolio overview by molecule type ($m), 2007-13 75

Table 20: Shire product portfolio overview by source ($m), 2001-07 79

Table 21: Shire product portfolio overview by source ($m), 2007-13 81

Table 22: Total Shire sales by business unit ($m), 2001-07 85

Table 23: Shire profit and loss account ($m), 2001-07 87

Table 24: Shire balance sheet ($m), 2001-07 89

Table 25: Shire operating revenue/cost analysis ($m), 2001-07 93

Table 26: Shire operating cost ratio analysis (percentage of total revenues), 2001-07 95

Table 27: Shire operating cost ratio analysis (percentage of total revenues), 2007-13 97

Table 28: Shire operating revenue/cost analysis ($m), 2007-13 100

Table 29: Shire capital employed ($m), 2001-07 102

Table 30: Shire EBIT return on capital employed ($m), 2001-07 104

Table 31: Shire EBIT pre-tax return/CE driver analysis (%), 2001-07 105

Table 32: Key products overview 108

Table 33: Vyvanse: overview 109

Table 34: Vyvanse: sales forecast ($m), 2007-13 110

Table 35: Intuniv: overview 112

Table 36: Intuniv: sales forecast ($m), 2007-13 113

Table 37: Daytrana: overview 116

Table 38: Daytrana: sales forecast ($m), 2007-13 117

Table 39: Adderall XR: overview 118

Table 40: Adderall XR: sales forecast ($m), 2007-13 119

Table 41: Adderall: overview 122

Table 42: Adderall: sales forecast ($m), 2007-13 123

Table 43: Elaprase: overview 125

Table 44: Elaprase: sales forecast ($m), 2007-13 126

Table 45: Replagal: overview 128

Table 46: Replagal: sales forecast ($m), 2007-13 129

Table 47: GA-GCB: overview 131

Table 48: GA-GCB: sales forecast ($m), 2007-13 132

Table 49: Lialda: overview 134

Table 50: Lialda: sales forecast ($m), 2007-13 135

Table 51: Pentasa: overview 137

Table 52: Pentasa: sales forecast ($m), 2007-13 138

Table 53: Fosrenol: overview 140

Table 54: Fosrenol: sales forecast ($m), 2007-13 141

Table 55: Firazyr: overview 143

Table 56: Firazyr: sales forecast ($m), 2007-13 144

Table 57: Shire's R&D pipeline (Phase I-registration) 146

List of Figures

Figure 1: Shire prescription pharmaceutical performance, sales ($m) and growth rate (%), 2001-13 5

Figure 2: Shire's financial performance ($m), 2001-13 6

Figure 3: Shire Rx revenue and financial performance ($m), 2001-13 8

Figure 4: Shire ADHD franchise revenue ($m), 2001-13 9

Figure 5: Shire Rx revenue ($m) by source, 2001-13 11

Figure 6: Shire SWOT analysis 12

Figure 7: Top 10 product sales ($m), forecast vs. actual, 2008 20

Figure 8: M&A/divestment history 28

Figure 9: Current corporate structure 32

Figure 10: Shire prescription pharmaceutical performance, sales ($m) and growth rate (%), 2001-13 34

Figure 11: Shire key sales growth driver & resistors ($m), 2001-07 37

Figure 12: Shire key sales growth drivers & resistors ($m), 2007-13 41

Figure 13: Shire prescription pharmaceutical sales by therapy area ($m), 2001-13 45

Figure 14: Shire prescription pharma sales by therapy area (% of total), 2001-13 51

Figure 15: Shire prescription pharmaceutical sales by geographic region ($m), 2001-13 53

Figure 16: Shire growth drivers and resistors by geographic region ($m), 2001-07 56

Figure 17: Shire drivers and resistors by geographic region ($m), 2007-13 60

Figure 18: Shire prescription pharmaceutical sales by geographic region (% of total), 2001-13 62

Figure 19: Shire launch/core/expiry configuration ($m), 2007-13 72

Figure 20: Shire prescription pharmaceutical sales by molecule type ($m), 2001-13 73

Figure 21: Shire growth drivers and resistors by molecule type ($m), 2007-13 76

Figure 22: Shire prescription pharmaceutical sales by source ($m), 2001-13 78

Figure 23: Shire growth drivers and resistors by source ($m), 2001-07 79

Figure 24: Shire growth drivers and resistors by source ($m), 2007-13 82

Figure 25: Shire Rx revenue by source, 2001-13 83

Figure 26: Shire operating revenue/cost analysis ($m), 2001-13 92

Figure 27: Shire operating cost ratio analysis (percentage of total revenues), 2001-13 98

Figure 28: Shire return on capital employed, EBIT margin and capital turnover, 2001-07 101

Figure 29: Return on CE formula 105