PharmaLeaders: Mid-Cap Biotechnology Benchmark Report - Sales Forecasts and Product Valuations of Innovative Biotechs

Table Of Contents
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 14
1.2 List of Figures 17
2 Introduction 24
2.1 Report Scope 24
2.2 Companies Covered 25
2.3 Upcoming Reports 26
2.4 Recently Published Reports 26
3 Market Dynamics 27
3.1 Sector Fundamentals 27
3.1.1 Growth Rate 27
3.1.2 R&D Spending 29
3.1.3 Company Outlook 33
3.1.4 Sales Forecasts 36
3.1.5 Product Valuations 39
3.2 FDA Approved 41 New Drugs in 2014 41
3.2.1 Drugs Approved in 2014 43
3.2.2 Multiple Approval Pathways Expedite Review of Innovatie Medicines 46
3.2.3 CDER Continues to Meet PDUFA Goal Dates for Review Cycles 51
3.2.4 GlobalDatas Forecast for 2014 Approvals: BMS Opdivo Projected to be Top Seller 52
3.3 Orphan Drugs: No Longer a Rare Opportunity 54
3.3.1 Historic Number of Orphan Drugs Approved in 2014 56
3.3.2 Orphan Drugs Approved in 2014 56
3.3.3 Celgenes Revlimid Will Eclipse Roches MabThera/Rituxan by 2018 61
3.4 FDA Approved 27 New Drugs in 2013 62
3.4.1 Drugs Approved in 2013 62
3.4.2 GlobalDatas Sales Forecasts for Drugs Approved in 2013 63
3.4.3 NME Approvals Drive Much Needed Value in the Pharmaceutical Market 65
3.4.4 Exceptional Uptake of Sovaldi and Tecfidera Paves the Way for New Optimism in Pharma 67
3.5 Patent Cliff to Erode $65 Billion in Sales by 2019 71
3.5.1 Top Patent Expiries 72
4 Collaboration and Acquisition Strategies 76
4.1 Deals Landscape 76
4.1.1 Overview 76
4.1.2 Therapeutic Analysis 79
4.2 M&A Analysis 82
4.2.1 Overview 82
4.2.2 Top Spenders 86
4.3 Licensing and Partnership Deals 94
4.3.1 Overview 94
4.3.2 Top Spenders 99
5 Financial Management 110
5.1 Revenue 111
5.1.1 Regeneron, Actelion, and Alexion 111
5.2 Year-to-Year Revenue Growth 113
5.2.1 Peer Group Leaders 113
5.2.2 Theravance and Vertex 115
5.3 Operating Income 116
5.3.1 Regeneron, Jazz, and Salix 116
5.3.2 Ironwood 118
5.4 Gross Profit Margin 118
5.4.1 Peer Group Leaders 118
5.5 Expense Performance Metrics 120
5.5.1 R&D Spending 120
5.5.2 R&D Spending Growth 122
5.5.3 SG&A Margin 124
5.6 Liquidity and Valuation Metrics 125
5.6.1 Capital Expenditures 125
5.6.2 Cash and Marketable Securities 127
5.6.3 Total Debt 128
5.6.4 Total Assets 130
5.6.5 Cash Ratio 131
5.6.6 Market Capitalization 132
5.6.7 Enterprise Value 133
6 Company Analysis 135
6.1 Acadia 135
6.1.1 Marketed Products 135
6.1.2 Nuplazid Sales Forecast 138
6.1.3 Nuplazid NPV & DCF 138
6.1.4 Clinical Pipeline 140
6.2 Actelion 143
6.2.1 Marketed Products 143
6.2.2 Opsumit and Tracleer Sales Forecasts 146
6.2.3 Opsumit NPV & DCF 147
6.2.4 Clinical Pipeline 148
6.3 Alexion 151
6.3.1 Marketed Products 151
6.3.2 Soliris Sales Forecast 154
6.3.3 Soliris NPV & DCF 155
6.3.4 Clinical Pipeline 156
6.4 BioMarin 159
6.4.1 Marketed Products 159
6.4.2 Naglazyme and BioMarin Sales Forecasts 161
6.4.3 Naglazyme NPV & DCF 162
6.4.4 Clinical Pipeline 164
6.5 Cubist 167
6.5.1 Marketed Products 167
6.5.2 Cubicin Sales Forecast 169
6.5.3 Cubicin NPV & DCF 171
6.5.4 Clinical Pipeline 172
6.6 Incyte 175
6.6.1 Marketed Products 175
6.6.2 Jakafi Sales Forecast 178
6.6.3 Jakafi NPV & DCF 178
6.6.4 Clinical Pipeline 179
6.7 Medivation 183
6.7.1 Marketed Products 183
6.7.2 Xtandi Sales Forecast 186
6.7.3 Xtandi NPV & DCF 186
6.7.4 Clinical Pipeline 188
6.8 Pharmacyclics 191
6.8.1 Marketed Products 191
6.8.2 Imbruvica Sales Forecast 194
6.8.3 Imbruvica NPV & DCF 194
6.8.4 Clinical Pipeline 196
6.9 Regeneron 199
6.9.1 Marketed Products 199
6.9.2 Eylea Sales Forecast 202
6.9.3 Eylea NPV & DCF 203
6.9.4 Clinical Pipeline 204
6.10 Vertex 208
6.10.1 Marketed Products 208
6.10.2 Kalydeco Sales Forecast 211
6.10.3 Kalydeco NPV & DCF 211
6.10.4 Clinical Pipeline 213
7 Future Outlook 216
8 Appendix 218
8.1 Research Methodology 218
8.1.1 Coverage 218
8.1.2 Secondary Research 218
8.2 About the Author 219
8.2.1 Adam Dion, Industry Analyst 219
8.3 Director, Healthcare Industry Dynamics 220
8.4 Global Head of Healthcare 220
8.5 About the Industry Dynamics Team 220
8.6 About GlobalData 221
8.7 Disclosure Information 221
8.8 Disclaimer 221

List Of Tables
1.1 List of Tables
Table 1: Pharmaceutical Industry, Sector Revenues ($bn) and CAGRs, 2011-2019 31
Table 2: Pharmaceutical Industry, Sector R&D Spending ($bn), 2008-2013 31
Table 3: Biotech Peer Group, Company Forecasts ($m), 2014-2019 35
Table 4: Biotech Peer Group, Product Forecasts ($m), 2013-2019 38
Table 5: NMEs Approved By the CDER, 2014 44
Table 6: Sales Forecasts ($m) for Key NME Approvals in 2014, 2014-2019 53
Table 7: Orphan Drug Approvals, 2014 57
Table 8: NMEs Approved in 2013 62
Table 9: Sales Forecasts ($m) for Key NME Approvals in 2013, 2014-2019 64
Table 10: Top Patent Expiries, Sales ($m), 2013-2019 73
Table 11: Biotechnology Sector, Headline M&A Deals, 2014 84
Table 12: Biotechnology Sector, Headline M&A Deals, 2013 85
Table 13: Salix, M&A Deals, Summary, 2005-2014 87
Table 14: Salix, M&A Deals, Financials, 2005-2014 87
Table 15: Sumitomo Dainnipon, M&A Deals, Summary, 2009-2014 88
Table 16: Sumitomo Dainippon, M&A Deals, Financials, 2009-2014 88
Table 17: Jazz, M&A Deals, Summary, 2011-2014 90
Table 18: Jazz, M&A Deals, Financials, 2011-2014 91
Table 19: Cubist, M&A Deals, Summary, 2009-2014 92
Table 20: Cubist, M&A Deals, Financials, 2007-2014 92
Table 21: Alexion, M&A Deals, Summary, 2008-2014 93
Table 22: Alexion, M&A Deals, Financials, 2006-2014 94
Table 23: Biotechnology Sector, Headline Licensing and Partnership Deals, 2014 95
Table 24: Biotechnology Sector, Headline Licensing and Partnership Deals, 2014 (Contd) 97
Table 25: Biotechnology Sector, Headline Licensing and Partnership Deals, 2013 98
Table 26: H. Lundbeck, Licensing Deals, Summary, 2008-2014 100
Table 27: H. Lundbeck, Licensing Deals, Financials, 2008-2014 101
Table 28: Isis, Licensing Deals, Summary, 2008-2014 102
Table 29: Isis, Licensing Deals, Financials, 2008-2014 103
Table 30: Seattle Genetics, Licensing Deals, Summary, 2009-2014 104
Table 31: Seattle Genetics, Licensing Deals, Financials, 2007-2014 105
Table 32: Alnylam, Licensing Deals, Summary, 2007-2014 106
Table 33: Alnylam, Licensing Deals, Financials, 2007-2014 107
Table 34: Regeneron, Licensing Deals, Summary, 2006-2014 108
Table 35: Regeneron, Licensing Deals, Financials, 2005-2014 109
Table 36: Acadia, Marketed Product Overview 135
Table 37: Nuplazid, Product Details 136
Table 38: Nuplazid, Milestone Details, 2012-2014 137
Table 39: Nuplazid, NPV Parameters 138
Table 40: Actelion, Marketed Products Overview 143
Table 41: Opsumit, Product Details 144
Table 42: Opsumit, Milestone Details, 2013-2014 145
Table 43: Opsumit, NPV Parameters 147
Table 44: Alexion, Marketed Product Overview 151
Table 45: Soliris, Product Details 152
Table 46: Soliris, Milestone Details, 2014 153
Table 47: Soliris, NPV Parameters 155
Table 48: BioMarin, Marketed Products Overview 160
Table 49: Naglazyme, Product Details 160
Table 50: Naglazyme, Milestone Details, 2005-2009 161
Table 51: Naglazyme, NPV Parameters 162
Table 52: Cubist, Marketed Products Overview 167
Table 53: Cubicin, Product Details 168
Table 54: Cubicin, Milestone Details, 2011-2014 169
Table 55: Cubicin, NPV Parameters 171
Table 56: Incyte, Marketed Product Overview 176
Table 57: Jakafi, Product Details 176
Table 58: Jakafi, Milestone Details, 2014 177
Table 59: Jakafi, NPV Parameters 178
Table 60: Medivation, Marketed Product Overview 183
Table 61: Xtandi, Product Details 184
Table 62: Xtandi, Milestone Details, 2014 185
Table 63: Xtandi, NPV Parameters 186
Table 64: Pharmacyclics, Marketed Product Overview 191
Table 65: Imbruvica, Product Details 192
Table 66: Imbruvica, Milestone Details, 2014 193
Table 67: Imbruvica, NPV Parameters 194
Table 68: Regeneron, Marketed Products Overview 199
Table 69: Eylea, Product Details 200
Table 70: Eylea, Milestone Details, 2014 201
Table 71: Eylea, NPV Parameters 203
Table 72: Vertex, Marketed Products Overview 209
Table 73: Kalydeco, Product Details 209
Table 74: Kalydeco, Milestone Details, 2013-2014 210
Table 75: Kalydeco, NPV Parameters 211

List Of Figures
1.2 List of Figures
Figure 1: Mid-Cap Biotech Peer Group, Revenue ($m) and Growth Rate, 2009-2013 28
Figure 2: Mid-Cap Biotech Peer Group, Revenue ($m) and Average Gross Margin, 2008-2013 29
Figure 3: Mid-Cap Biotech Peer Group, R&D Spending ($m) and Growth Rate 2009-2013 30
Figure 4: Global Marketed Product and Pipeline Sales ($m) Contributions, 2019 32
Figure 5: Total Pharmaceutical Market Pipeline Revenue ($m), 2014-2019 33
Figure 6: Mid-Cap Biotech Peer Group, Company Sales ($m), 2013 vs. 2019 34
Figure 7: Mid-Cap Biotech Peer Group, Product Forecasts ($m), 2019 37
Figure 8: Mid-Cap Biotech Peer Group, Leading Products, NPV ($m) 40
Figure 9: Number of NMEs Filed With and Approved by the CDER, 2004-2014 42
Figure 10: Number of BLAs Approved by CDER, 2004-2014 43
Figure 11: CDER Median Total Time (Months) to Drug Approval, Priority Review, 1993-2014 46
Figure 12: Status of CDER Breakthrough Therapy Requests, 2014 48
Figure 13: Percentage of Total Breakthrough Therapy Requests By Therapeutic Area, 2014 49
Figure 14: Percentage of Total Breakthrough Therapy Approvals By Therapeutic Area, 2014 49
Figure 15: Percentage of Total NMEs Approved by the CDER by Pathway, 2011-2014 51
Figure 16: Percentage of Total NMEs Approved During the First Review Cycle and First in the US, 2011-2014 52
Figure 17: Net Present Value ($m) for Key Approvals, 2014 54
Figure 18: Number of Orphan Drugs Approved, 1983-2014 56
Figure 19: Orphan Drug Peer Group Forecast ($m), 2009-2019 58
Figure 20: Leading Orphan Drug Sales ($m), Top 25, 2019 59
Figure 21: Leading Orphan Drug Sales ($m), Contd, 2019 60
Figure 22: Revlimid vs. MabThera/Rituxan Sales ($m), 2006-2019 61
Figure 23: Combined Revenue ($m) Projections for 2013 vs. 2012 FDA Approvals, 2012-2019 65
Figure 24: First Full-Year Sales ($m) for Major Product Launches by Year, 2009-2013 66
Figure 25: Revenue ($m) Projections for 2013 FDA Approvals, 2014-2019 68
Figure 26: Patent Cliff Sales ($m) Erosion, 2013-2019 72
Figure 27: Biotechnology Sector, Total M&As and Licensing Deals and Deal Values ($m), 2009-2014 77
Figure 28: Biotechnology Sector, Total and Average Milestone Payments ($m), 2010-2014 78
Figure 29: Biotechnology Sector, Total and Average Upfront Payments ($m), 2010-2014 79
Figure 30: Biotechnology Sector, Total Number of Deals by Therapy Area, 2010-2014 80
Figure 31: Biotechnology Sector, Distribution (%) of Deals by Therapy Area, 2010-2014 81
Figure 32: Biotechnology Sector, Total Deal Value ($m) by Therapy Area, 2010-2014 82
Figure 33: Biotechnology Sector, Number of M&A Deals and Deal Values ($m), 2009-2014 83
Figure 34: Biotechnology Sector, M&A Deal Values ($m) by Company, 2010-2014 86
Figure 35: Biotechnology Sector, Total Number of Licensing Deals and Deal Values ($m), 2009-2014 94
Figure 36: Biotechnology Sector, Licensing and Partnership Deal Values ($m) by Company, 2010-2014 99
Figure 37: Revenue ($m) by Company, 2013 112
Figure 38: Revenue Growth (%) by Company, 2013 115
Figure 39: Operating Income ($m) by Company, 2013 117
Figure 40: Gross Profit Margin (%) by Company, 2013 119
Figure 41: R&D Spending ($m) by Company, 2013 121
Figure 42: R&D Spending Growth (%) By Company, 2013 123
Figure 43: SG&A Spending (%) of Revenue by Company, 2013 125
Figure 44: Capex ($m) by Company, 2013 126
Figure 45: Cash and Marketable Securities ($m) by Company, 2013 128
Figure 46: Total Debt ($m) by Company, 2013 129
Figure 47: Total Assets ($m) by Company, 2013 131
Figure 48: Cash Ratio (%) by Company, 2013 132
Figure 49: Market Capitalization ($m) by Company 133
Figure 50: Enterprise Value ($m) by Company 134
Figure 51: Nuplazid Sales Forecast ($m), 2015-2019 138
Figure 52: Nuplazid Net Present Value ($m) 139
Figure 53: Nuplazid Net Profit and DCF ($m), 2015-2029 139
Figure 54: Acadia, Number of Pipeline Products vs. Number of Clinical Trials 140
Figure 55: Nuplazid, Number of Clinical Trials 140
Figure 56: Acadia, Number of Clinical Trials in Late-Stage by Therapy Area 141
Figure 57: Acadia, Percentage of Late-Stage Pipeline 141
Figure 58: Acadia, Number of Clinical Trials by Phase 142
Figure 59: Acadia, Number of Clinical Trials by Indication, CNS Disorders 142
Figure 60: Opsumit and Tracleer Sales Forecasts ($m), 2006-2019 146
Figure 61: Actelion Total Revenue and Forecast ($m), 2006-2019 146
Figure 62: Opsumit, Net Present Value ($m) 147
Figure 63: Opsumit, Net Profit and DCF ($m), 2014-2029 148
Figure 64: Actelion, Number of Pipeline Products vs. Number of Clinical Trials 148
Figure 65: Actelion, Number of Clinical Trials 149
Figure 66: Actelion, Number of Clinical Trials in Late-Stage by Therapy Area 149
Figure 67: Actelion, Percentage of Late-Stage Pipeline 150
Figure 68: Actelion, Number of Clinical Trials by Phase 150
Figure 69: Actelion, Number of Clinical Trials by Indication, Cardiovascular Disorders 151
Figure 70: Soliris Sales Forecast ($m), 2007-2019 154
Figure 71: Alexion, Revenue and Forecast ($m), 2009-2019 155
Figure 72: Soliris, Net Present Value ($m) 156
Figure 73: Soliris, Net Profit and DCF ($m), 2014-2029 156
Figure 74: Alexion, Number of Pipeline Products vs. Number of Clinical Trials 157
Figure 75: Soliris, Number of Clinical Trials 157
Figure 76: Alexion, Number of Clinical Trials in Late-Stage by Therapy Area 158
Figure 77: Alexion, Percentage of Late-Stage Pipeline 158
Figure 78: Alexion, Number of Clinical Trials by Phase 159
Figure 79: Naglazyme Sales Forecast ($m), 2008-2019 161
Figure 80: BioMarin Total Revenue and Forecast ($m), 2008-2019 162
Figure 81: Naglazyme, NPV ($m) 163
Figure 82: Naglazyme, Net Profit and DCF ($m), 2014-2029 163
Figure 83: BioMarin, Number of Pipeline Products vs. Number of Clinical Trials 164
Figure 84: BioMarin, Marketed Products Clinical Trials 164
Figure 85: BioMarin, Number of Clinical Trials by Therapy Area 165
Figure 86: BioMarin, Percentage of Late-Stage Pipeline 165
Figure 87: BioMarin, Number of Clinical Trials by Phase 166
Figure 88: BioMarin, Number of Clinical Trials by Indication, Metabolic Disorders 166
Figure 89: Cubicin Sales Forecast ($m), 2008-2019 170
Figure 90: Cubist Revenue and Forecast ($m), 2008-2019 170
Figure 91: Cubicin NPV ($m) 171
Figure 92: Cubicin Net Profit and DCF ($m), 2014-2022 172
Figure 93: Cubist, Number of Pipeline Products vs. Number of Clinical Trials 172
Figure 94: Cubist, Marketed Products Clinical Trials 173
Figure 95: Cubist, Percentage of Late-Stage Pipeline 173
Figure 96: Cubist, Number of Clinical Trials in Late-Stage by Therapy Area 174
Figure 97: Cubist, Number of Clinical Trials by Phase 174
Figure 98: Cubist, Number of Clinical Trials by Indication, Infectious Diseases 175
Figure 99: Jakafi Sales Forecast ($m), 2012-2019 178
Figure 100: Jakafi NPV ($m) 179
Figure 101: Jakafi, Net Profit and DCF ($m), 2014-2029 179
Figure 102: Incyte, Number of Pipeline Products vs. Number of Clinical Trials 180
Figure 103: Incyte, Marketed Products Clinical Trials 180
Figure 104: Incyte, Number of Clinical Trials in Late-Stage by Therapy Area 181
Figure 105: Incyte, Percentage of Late-Stage Pipeline 181
Figure 106: Incyte, Number of Clinical Trials by Phase 182
Figure 107: Incyte, Number of Clinical Trials in Late-Stage by Indication, Hematology 182
Figure 108: Xtandi Sales Forecast ($m), 2012-2019 186
Figure 109: Xtandi NPV ($m) 187
Figure 110: Xtandi Net Profit and DCF ($m), 2014-2029 187
Figure 111: Medivation, Number of Pipeline Products vs. Number of Clinical Trials 188
Figure 112: Medivation, Marketed Products Clinical Trials 188
Figure 113: Medivation, Percentage of Late-Stage Pipeline 189
Figure 114: Medivation, Number of Clinical Trials in Late-Stage by Therapy Area 189
Figure 115: Medivation, Number of Clinical Trials by Phase 190
Figure 116: Medivation, Number of Clinical Trials in Late-Stage by Indication, Oncology and CNS 190
Figure 117: Imbruvica Sales Forecast ($m), 2013-2019 194
Figure 118: Imbruvica NPV ($m) 195
Figure 119: Imbruvica Net Profit and DCF ($m), 2014-2029 195
Figure 120: Pharmacyclics, Number of Pipeline Products vs. Number of Clinical Trials 196
Figure 121: Pharmacyclics, Marketed Products Clinical Trials 196
Figure 122: Pharmacyclics, Percentage of Late-Stage Pipeline 197
Figure 123: Pharmacyclics, Number of Clinical Trials in Late-Stage by Therapy Area 197
Figure 124: Pharmacyclics, Number of Clinical Trials by Phase 198
Figure 125: Pharmacyclics, Number of Clinical Trials in Late-Stage by Indication, Oncology 198
Figure 126: Eylea Sales Forecast ($m), 2012-2019 202
Figure 127: Regeneron Revenue Forecast ($m), 2012-2019 202
Figure 128: Eylea NPV ($m), 203
Figure 129: Eylea Net Profit and DCF ($m), 2014-2029 204
Figure 130: Regeneron, Number of Pipeline Products vs. Number of Clinical Trials 205
Figure 131: Regeneron, Marketed Products Clinical Trials 205
Figure 132: Regeneron, Percentage of Late-Stage Pipeline 206
Figure 133: Regeneron, Number of Clinical Trials in Late-Stage by Therapy Area 206
Figure 134: Regeneron, Number of Clinical Trials by Phase 207
Figure 135: Regeneron, Number of Clinical Trials by Indication, Ophthalmology 207
Figure 136: Regeneron, Selected Product NPVs 208
Figure 137: Kalydeco Sales Forecast ($m), 2012-2019 211
Figure 138: Kalydeco NPV ($m) 212
Figure 139: Kalydeco, Net Profit and DCF ($m), 2014-2029 212
Figure 140: Vertex, Number of Pipeline Products vs. Number of Clinical Trials 213
Figure 141: Vertex, Marketed Products Clinical Trials 213
Figure 142: Vertex, Percentage of Late-Stage Pipeline 214
Figure 143: Vertex, Number of Clinical Trials in Late-Stage by Therapy Area 214
Figure 144: Vertex, Number of Clinical Trials by Phase 215
Figure 145: Vertex, Number of Clinical Trials in Late-Stage by Indication 215

Menu 2

Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam.

Menu 3

Eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae vitae dicta sunt explicabo.