Serono: PharmaVitae Profile

CHAPTER 1 EXECUTIVE SUMMARY 4
Key findings 4
Historical and forecast ethical sales performance 5
Therapeutic strategy 6
Launch and expiry outlook 9
Externalization, geographic and molecule type strategies 11
Externalization strategy 12
Geographic strategy 13
Molecule type strategy 13
SWOT analysis 14
Strengths 15
Weaknesses 15
Opportunities 16
Threats 17
CHAPTER 2 CORPORATE HISTORY 29
Key findings 29
Background 30
Key corporate developments 30
M&A history 32
M&A strategy 33
Merck KGaA acquisition 33
Current corporate structure 35
Biopharmaceuticals 35
Current management team 37
CHAPTER 3 HISTORICAL PERFORMANCE 38
Key findings 38
Introduction 39
Revenue and growth rate analysis, 2002-05 39
Revenue and growth rate vs. peer set 40
Product analysis, 2002-05 43
Growth drivers 44
Rebif 44
Gonal-f 44
Saizen 45
Growth resistors 45
Metrodin HP 45
Other women’s health 45
Operating revenue and cost analysis, 2002-05 46
Operating revenue/cost analysis 48
CHAPTER 4 FORECAST PERFORMANCE 51
Key findings 51
Introduction 52
Revenue and growth rate, 2005-11 52
Product analysis, 2005-11 53
Growth drivers 58
Rebif 58
Oral cladribine 59
Raptiva 59
Gonal-f 59
Humax-CD4 59
Growth resistors 60
Novantrone - for CNS and oncology 60
Therapy area analysis, 2005-11 62
CNS 64
AIID 65
Women’s health 65
Diabetes & endocrinology 65
Oncology 66
Therapy area focus 66
Launches and expiries analysis, 2005-11 69
Launch portfolio 69
Core portfolio 71
Expiry portfolio 72
Launch/core/expiry configuration 75
Externalization analysis, 2005-11 78
Geographic analysis, 2005-11 83
Molecule type analysis, 2005-11 88
CHAPTER 5 KEY PRODUCTS AND COMPETITORS 93
Key findings 93
Overview 94
CNS 95
Rebif 95
Overview 95
Sales forecast 96
Newsflow 96
Competitive landscape 98
Novantrone (CNS) 101
Overview 101
Sales forecast 102
Newsflow 102
Oral cladribine 104
Overview 104
Sales forecast 105
Newsflow 106
Competitive landscape 106
Women’s health 109
Gonal-f 109
Overview 109
Sales forecast 110
Newsflow 110
Competitive landscape 111
Ovidrel 114
Overview 114
Sales forecast 115
Newsflow 115
Competitive landscape 115
Serono’s minor women’s health products 117
Sales forecast 117
Diabetes & endocrinology 118
Serono’s somatropin group of products 118
Saizen 119
Overview 119
Sales forecast 120
Newsflow 120
Competitive landscape 120
Serostim and Zorbtive 122
Serostim 122
Zorbtive 123
Phenoptin 124
Overview 124
Sales forecast 125
Newsflow 126
Competitive landscape 126
Oncology 128
Novantrone (oncology) 128
Overview 128
Sales forecast 129
Newsflow 129
Humax-CD4 131
Overview 131
Sales forecast 132
Newsflow 132
Competitive landscape 133
Autoimmune and inflammatory disorders (AIID) 135
Raptiva 135
Overview 135
Sales forecast 136
Newsflow 136
Competitive landscape 137
R&D pipeline 139
CHAPTER 6 APPENDIX 140
IMS vs. company-reported data reconciliation 140
Abbreviations 143
Exchange rates 144
List of Tables
Table 1: Serono Group Corporate Executive Committee 37
Table 2: Peer set overview 40
Table 3: Operating revenue/cost analysis ($m), 2002-05 46
Table 4: Operating cost ratio analysis (% of total revenues), 2002-05 48
Table 5: Product portfolio overview, sales ($m), 2005-11 54
Table 6: Therapy area overview, sales ($m), 2005-11 62
Table 7: Launch portfolio overview, sales ($m), 2005-11 69
Table 8: Core portfolio overview, sales ($m), 2005-11 71
Table 9: Expiry portfolio overview, sales ($m), 2005-11 73
Table 10: Externally sourced portfolio, sales ($m), 2005-11 78
Table 11: Molecule type overview, sales ($m), 2005-11 88
Table 12: Key products overview 94
Table 13: Rebif: overview 95
Table 14: Rebif: sales forecast ($m), 2005-11 96
Table 15: Rebif: newsflow 96
Table 16: Novantrone: overview 101
Table 17: Novantrone: sales forecast ($m), 2005-11 102
Table 18: Novantrone: newsflow 102
Table 19: Oral cladribine: overview 104
Table 20: Oral cladribine: sales forecast ($m), 2005-11 105
Table 21: Oral cladribine: newsflow 106
Table 22: Gonal-f: overview 109
Table 23: Gonal-f: sales forecast ($m), 2005-11 110
Table 24: Gonal-f: newsflow 110
Table 25: Ovidrel: overview 114
Table 26: Ovidrel: sales forecast ($m), 2005-11 115
Table 27: Ovidrel: newsflow 115
Table 28: Serono’s other women’s health products: sales forecast ($m), 2005-11 117
Table 29: Saizen: overview 119
Table 30: Saizen: sales forecast ($m), 2005-11 120
Table 31: Saizen: newsflow 120
Table 32: Serostim: sales forecast ($m), 2005-11 122
Table 33: Zorbtive: sales forecast ($m), 2005-11 123
Table 34: Phenoptin: overview 124
Table 35: Phenoptin: sales forecast ($m), 2005-11 125
Table 36: Phenoptin: newsflow 126
Table 37: Novantrone (oncology): overview 128
Table 38: Novantrone (oncology): sales forecast ($m), 2005-11 129
Table 39: Novantrone (oncology): newsflow 129
Table 40: Humax-CD4: overview 131
Table 41: Humax-CD4: sales forecast ($m), 2005-11 132
Table 42: Humax-CD4: newsflow 132
Table 43: Raptiva: overview 135
Table 44: Raptiva: sales forecast ($m), 2005-11 136
Table 45: Raptiva: newsflow 136
Table 46: Serono’s R&D pipeline (Phase I-registration) 139
Table 47: Exchange rates, 2005 144
List of Figures
Figure 1: Historical and forecast ethical sales performance (% CAGR), Serono and biotechnology peer set 5
Figure 2: Therapeutic focus vs. Biotechnology peer set (%), 2005 7
Figure 3: Launch, core and expiry, absolute sales growth, 2005-11 (sales as % of 2005 sales), Serono 9
Figure 4: Launch, core and expiry, absolute sales growth, 2005-11 (sales as % of 2005 sales), peer set 10
Figure 5: Molecule type, externalization and geographic market dependency (%) vs. peer set, 2005 11
Figure 6: Molecule type, externalization and geographic market dependency (%) vs. peer set, 2011 12
Figure 7: SWOT analysis of Serono 14
Figure 8: M&A/divestment history 32
Figure 9: Current corporate structure 35
Figure 10: Revenue & growth rate (ethical sales) ($m), 2002-05 39
Figure 11: Ethical revenue ($m) and growth rate (%) vs. peer set, 2002-05 41
Figure 12: Growth drivers/resistor products of historical revenue performance ($m), 2002-05 43
Figure 13: Operating revenue/cost analysis ($m), 2002-05 47
Figure 14: Operating cost ratio analysis (% of total revenues), 2002-05 49
Figure 15: Operating cost ratio vs. peer set, 2002-05 50
Figure 16: Ethical revenue ($m) and growth rate (%), 2005-11 52
Figure 17: Top five products by sales ($m), 2005 56
Figure 18: Top five products by sales ($m), 2011 57
Figure 19: Growth drivers and resistors by product, 2005-11 58
Figure 20: Key strategic products, sales ($m), 2005-11 61
Figure 21: Ethical sales by therapy area ($m), 2005-11 63
Figure 22: Growth drivers and resistors by therapy area (%), 2005-11 64
Figure 23: Ethical sales by therapy area (%), 2005-11 66
Figure 24: Therapy area focus compared with peer set (% total ethical sales), 2005 67
Figure 25: Therapy area focus compared with peer set (% total ethical sales), 2011 68
Figure 26: Launch schedule, sales ($m), 2005-11 70
Figure 27: Core products sales growth ($m), 2005-11 72
Figure 28: Expiry schedule, sales ($m), 2005-11 74
Figure 29: Launch, core and expiry, sales ($m), 2005-11 75
Figure 30: Launch, core and expiry, absolute sales growth, 2005-11 (sales as % of 2005 sales), Serono 76
Figure 31: Launch, core and expiry, absolute sales growth, 2005-11 (sales as % of 2005 sales), peer set 77
Figure 32: Externalization dependency, sales ($m), 2005-11 79
Figure 33: Growth drivers and resistors, externally vs. internally discovered products, sales ($m), 2005-11 80
Figure 34: Externalization dependency vs. peer set, % total sales, 2005 81
Figure 35: Externalization dependency vs. peer set, % total sales, 2011 82
Figure 36: Geographical sales breakdown ($m), 2005-11 83
Figure 37: Growth drivers and resistors by geography, sales ($m), 2005-11 84
Figure 38: US dependency vs. peer set, % total sales, 2005 86
Figure 39: US dependency vs. peer set, % total sales, 2011 87
Figure 40: Molecule type sales breakdown ($m), 2005-11 89
Figure 41: Molecule type absolute growth ($m), 2005-11 90
Figure 42: Biologics dependency vs. peer set, % total sales, 2005 91
Figure 43: Biologics dependency vs. peer set, % total sales, 2011 92
Figure 44: Serono’s recombinant somatropin products 118
Figure 45: IMS vs. company-reported ethical sales discrepancy ($m), 2005 141
Figure 46: IMS vs. company-reported ethical sales forecast growth rates (%), 2005-11 142