Astellas Pharma: Pipeline, Products, Performance, Potential

Table of Contents

Latest Results

EXECUTIVE SUMMARY

• Introduction
• Financial Performance 2005
  • Sales and Market Position
  • Income
    • Sales, Costs and Operating Income
    • Operating Income By Business Area
    • Operating Income By Business Area
  • Expenditure
    • Capital Expenditure
    • Capital Expenditure By Business Area
    • Capital Expenditure By Business Area
    • R&D Expenditure
    • R&D Expenditure
  • Divisional Performance
    • Sales By Business Area
    • Sales By Business Area
    • Total Assets By Business Area
    • Total Assets By Business Area
  • Geographic Performance
    • Sales By Destination
    • Sales By Destination
    • Sales By Origin
    • Sales By Origin
    • Operating Income (Loss) By Geographic Area
    • Operating Income (Loss) By Geographic Area
    • Total Assets By Geographical Area
    • Total Assets By Geographical Area
• Company Strategy
  • Objectives for FY2006-FY2008 (April 2005-March 2008):
  • OTC Pharmaceuticals Business
  • Key Mergers, Acquisitions and Divestitures
  • Key Agreements
  • Production
  • Employees
    • Employees
    • Employees
    • Employees and Productivity
• Product/R&D Overview
  • Key Products
    • Recent Product Launches
    • Recent Product Approvals
    • Products Withdrawn
  • R&D Strategy
  • Key R&D Projects
  • R&D Pipeline Overview
  • Sales Forecasts
    • Sales of Current Top Ten Products (2000A-2010E)
• Other Factors Affecting the Bottom Line
• Conclusions

PRODUCT PORTFOLIO / RESEARCH & DEVELOPMENT

• Major Products, Therapeutic Areas and Sales
• R&D Pipeline

• Cardiovascular - Products
  • Major Launched Products
  • Adenocard
    • Mode of Action
    • Patents/Licensees
    • Key Markets/Indications/Formulations
    • Generic Competition
  • Adenoscan
    • Mode of Action
    • Sales
    • Key Markets/Indications
    • Lawsuits
    • Sales Forecast
  • Adenoscan Sales (2000A-2010E)
  • Carperitide
    • Mode of Action
    • Key Markets/Indications/Further Development
    • Further Development
  • Cibenol
  • Dorner
    • Mode of Action
    • Sales
    • Key Markets/Indications
    • Further Development
    • Competitor Products
    • Sales Forecast
  • Dorner Sales (2000A-2010E)
  • Frandol
    • Sales Forecast
  • Fransol Sales (2000A-2010E)
  • Hypoca/Cyress
    • Mode of Action
    • Sales
    • Key Markets/Indications
    • Competitor Products
    • Further Development
    • Sales Forecast
  • Hypoca Sales (2000A-2010E)
    • Clinical Trial Results
  • Lipitor
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Competitor Products
    • Sales Forecast
  • Lipitor Sales (2000A-2010E)
  • Micardis
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Competitor Products
    • Sales Forecast
  • Micardis Sales (2003A-2010E)
    • Clinical Trial Results
  • Milrila
    • Mode of Action
    • Key Markets/Indications/Formulations
  • Nivadil
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Sales Forecast
  • Nivadil Sales (2000A-2010E)
  • Perdipine
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Sales Forecast
  • Perdipine Sales (2000A-2010E)
  • Solinase
    • Mode of Action
    • Key Markets
  • Vaprisol
    • Mode of Action
    • Key Markets/Indications
    • Further Development
• Cardiovascular - R&D
  • Regadenoson
    • Mode of Action/Indication
    • Clinical Trial Results
  • RSD1235
    • Patents/Licensees
    • Development/Launch Schedule
    • Clinical Trial Results
  • YM150
• Cardiovascular - Summary
  • Growth Potential
  • Limiting Factors
• Urology - Products
  • Major Launched Products
  • Harnal/Omnic/Flomax
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Lawsuits
    • Sales Forecast
    • Flomax/Harnal Sales (2000A-2010E)
      • Clinical Trial Results
  • Vesicare
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Clinical Trial Results
• Urology - R&D
  • Prodel
    • Mode of Action
  • YM155
    • Mode of Action
  • YM178
  • YM672 (IPD-1151T)
    • Mode of Action
    • Licensing
    • Development/Launch Schedule
• Urology - Summary
  • Growth Potential
• Inflammation & Immunology - Products
  • Major Launched Products
  • Atock/Foradil
    • Mode of Action
    • Key Markets/Indications/Formulations
  • Intal
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Sales Forecast
  • Intal Sales (200A-2010E)
  • Prograf
    • Mode of Action
    • Sales
    • Licensing Agreements
    • Key Markets/Indications
    • Further Development
  • New Indications
    • Discontinued Formulations
    • Safety Issues/Labelling
    • Sales Forecast
  • Prograf Sales (2000A-2010E)
• Inflammation & Immunology - R&D
  • AGI-1096
  • Celecoxib
    • Mode of Action
    • Development Status
  • FK-778
  • Parecoxib
    • Mode of Action
    • Key markets
  • For the short-term treatment of post-operative pain
  • Valdecoxib (YM974)
    • Mode of Action
    • Key Markets
• Inflammation & Immunology - Summary
  • Growth Potential
  • Limiting Factors
• Gastrointestinal - Products
  • Major Launched Products
  • Colonel (HSR 237)
    • Mode of Action
    • Key Markets/Indications/Formulations
  • Ganaton
    • Mode of Action
    • Key Markets/Indications/Formulations
  • Gaster/Pepcid
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Lawsuits/Patents
    • Competitor Products
    • Sales Forecast
  • Gaster/Pepcid Sales (2000A-2010E)
  • Nasea
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Sales Forecast
  • Nasea Sales (2000A-2010E)
• Gastrointestinal - R&D
  • YM443
    • Mode of Action
    • Patents/Licensees
• Gastrointestinal - Summary
  • Growth Potential
  • Limiting Factors
• Infectious Disease - Products
  • Major Launched Products
  • Aimmugen
    • Mode of Action
    • Patents
    • Key Markets
  • AmBisome
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Labelling Issues
    • Sales Forecast
  • AmBisome Sales (2000A-2010E)
  • Cefamezin
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Sales Forecast
  • Cefamezin Sales (2000A-2010E)
  • Cefspan
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Sales Forecast
  • Cefspan Sales (2000A-2010E)
  • Cefzon/Omnicef
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Lawsuits
    • Sales Forecast
  • Cefzon Sales (2000A-2010E)
  • Funguard
    • Mode of Action
    • Key Markets/Indications/Formulations
    • Further Development
    • Sales
    • Competitor Products
    • Sales Forecast
  • Funguard Sales (2003A-2010E)
  • Infergen/Advaferon
    • Mode of Action
    • Sales
    • Patents
    • Key Markets/Indications/Formulations
    • Further Development
  • Ketek
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Competitor Products
  • Targocid
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
• Infectious Disease - R&D
  • Garenoxicin
  • Telavancin
    • Mode of Action
    • Licensing
    • Clinical Trial Results
  • TD-1792
    • Mode of Action
    • Licensing
• Infectious Disease - Summary
  • Growth Potential
  • Limiting Factors
• Central Nervous System - Products
  • Major Launched Products
  • Dogmatyl
    • Sales
    • Key Markets
    • Sales Forecast
  • Dogmatyl Sales (2002A-2010E)
  • Luvox
    • Mode of Action
    • Sales
    • Key Markets
    • Further Development
    • Sales Forecast
  • Luvox Sales (2000A-2010E)
  • Myslee
    • Mode of Action
    • Sales
    • Patents/Licensees
    • Key Markets/Indications/Formulations
    • Further Development
    • Competitor Products
    • Sales Forecast
  • Myslee Sales (2000A-2010E)
  • Seroquel
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Competitor Products
    • Sales Forecast
  • Seroquel Sales (2000A-2010E)
• Central Nervous System - R&D
  • ACR16
    • Mode of Action
  • FK962
    • Mode of Action
    • Development Status
  • XP13512
    • Mode of Action
    • Patents
    • Clinical Trial Results
• Central Nervous System - Summary
  • Growth Potential
• Dermatology - Products
  • Major Launched Products
  • Protopic
    • Mode of Action
    • Sales
    • Licensing Agreements
    • Key Markets/Indications
    • Further Development
    • Discontinued Indications/Formulations
    • Safety Issues/Labelling
    • Competitor Products
    • Sales Forecast
  • Protopic Sales (2000A-2010E)
• Dermatology - R&D
• Dermatology - Summary
• Metabolic - Products
  • Major Launched Products
  • Starsis
    • Mode of Action
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Sales Forecast
  • Starsis Sales (2000A-2010E)
    • Clinical Trial Results
• Metabolic - R&D
• Metabolic - Summary
  • Growth Potential
• Bone Disorders - Products
  • InductOs (YM484; rhBMP-2, dibotermin alpha)
    • Mode of Action
    • Key Markets/Indications/Formulations
• Bone Disorders - R&D
  • Minodronate
    • Mode of Action
  • Strontium ranelate (FK481)
    • Mode of Action
• Bone Disorders - Summary
  • Growth Potential
• Oncology - Products
  • Eligard
    • Mode of Action
    • Key Markets/Indications/Formulations
    • Lawsuits
  • SMANCS
    • Mode of Action
    • Key Markets/Indications/Formulations
• Oncology - R&D
  • Degarelix
  • Oprelvekin
    • Mode of Action
    • Development Status
  • FK-228
    • Mode of Action
• Oncology - Summary
  • Growth Potential
  • Limiting Factors
• Discontinued
  • Atrisone
    • Mode of Action
  • Bisphonal
    • Mode of Action
  • Cholebine
    • Mode of Action
  • Farom
    • Mode of Action
  • FK-352B
  • FK-614
  • MBI 226
  • PYM50028
    • Mode of Action
    • Licensees
  • ReoPro
    • Mode of Action
  • Rescula Eye Drops
    • Mode of Action
    • Japanese Withdrawal
  • Selodenoson/DTI-0009
  • Tilmacoxib
  • TRK-820
    • Mode of Action
  • YM337
  • YM454
    • Mode of Action
    • Further Developments
    • Patents
  • YM598

APPENDIX 1 - FINANCIAL PERFORMANCE

• Astellas Proforma Results
  • Sales, Costs and Operating Income
  • Profitability and Research Ratios
  • R&D Expenditure and Capital Expenditure
  • Current Assets, Liabilities and Ratio
  • Assets, Cash and Liquidity
  • Employees and Productivity
• Fujisawa Data
  • Sales By Business Area - Fujisawa
  • Sales By Business Area - Fujisawa
  • Operating Income (Loss) By Business Area - Fujisawa
  • Capital Expenditure By Business Area - Fujisawa
  • Total Assets By Business Area - Fujisawa
  • Total Assets by Business Area - Fujisawa
  • Sales By Destination - Fujisawa
  • Sales By Destination - Fujisawa
  • Sales By Origin - Fujisawa
  • Sales By Origin - Fujisawa
  • Operating Income (Loss) By Geographic Area - Fujisawa
  • Total Assets By Geographical Area - Fujisawa
• Yamanouchi Data
  • Operating Income By Business Area - Yamanouchi
  • Operating Income By Business Area - Yamanouchi
  • Capital Expenditures By Business Area - Yamanouchi
  • Capital Expenditures By Business Area - Yamanouchi
  • Sales By Business Area - Yamanouchi
  • Sales By Business Area - Yamanouchi
  • Total Assets By Business Area - Yamanouchi
  • Total Assets by Business Area - Yamanouchi
  • Sales By Destination - Yamanouchi
  • Sales By Destination - Yamanouchi
  • Sales By Origin - Yamanouchi
  • Sales By Origin - Yamanouchi
  • Operating Income (Loss) by Geographical Area - Yamanouchi
  • Total Assets By Geographical Area - Yamanouchi

APPENDIX 2 - KEY CORPORATE EVENTS

APPENDIX 3 - KEY AGREEMENTS

• Adir Et Cie
  • 18th May 2001
• Ajinomoto Co Inc
• American BioScience Inc (ABS)
  • 1997
• AtheroGenics Inc
  • 12th January 2004
  • 2nd February 2006
• Boehringer Ingelheim (BI)
  • 1994
  • 24th January 2002
  • 16th August 2004
• Cardiome Pharma Corp
  • 16th October 2003
  • 23rd February 2005
  • 19th October 2005
• Carlsson Research AB
  • 7th February 2005
• CV Therapeutics Inc (CVT)
  • 11th July 2000
• Daiichi Sankyo Co Ltd
  • 27th August 2004
• Gilead Sciences Inc
  • 7th April 1995
  • 7th April 1999
• GlaxoSmithKline
  • 21st May 1998
  • 20th December 1999
  • 7th June 2000
  • November 2000
  • 4th June 2003
  • 8th August 2003
• Gloucester Pharmaceuticals Inc
  • 15th April 2004
• Ferring Pharmaceuticals
  • 31st January 2006
• Merck KGaA
  • 11th May 1998
  • November 2000
• Metabolex Inc
  • 20th March 2002
  • 18th March 2003
  • 2nd May 2005
  • 8th November 2005
• Nippon Kayaku Co Ltd
  • 7th February 2005
• Novartis
  • December 2000
  • 1st September 2001
• Ono Pharmaceutical Co Ltd
  • January 1999
• Pfizer
  • December 1997
  • April 1998
  • 13th July 1998
  • 28th March 2001
  • 31st May 2004
• Pharmagenesis Inc
  • 17th September 2002
• sanofi-aventis
  • 13th April 1998
  • 4th September 2000
  • 8th December 2000
  • 10th July 2001
  • 14th November 2001
  • 19th April 2002
  • 13th February 2003
  • 20th November 2003
  • 16th December 2005
• Senju Pharmaceutical Co Ltd
  • January 2005
• Taiho Pharmaceuticals Co Ltd
  • 23rd January 2003
• Taisho Toyama Pharmaceutical Co Ltd
  • 26th January 2006
• TAP Pharmaceutical Products Inc
  • 9th November 2000
• Tercica Inc
  • 29th April 2004
• Wyeth
• Zeria Pharmaceutical Co Ltd
  • 1st July 2002

APPENDIX 4 - INFRASTRUCTURE

• Manufacturing Facilities

APPENDIX 5 - KEY PHARMACEUTICAL SUBSIDIARIES/JOINT VENTURES

• Subsidiaries
• Joint Ventures

APPENDIX 6 - PRODUCT INDEX