塩野義製薬：製薬企業分析レポート

Abstract

Shionogi is active in the following therapeutic areas: Antibiotics, Central Nervous System, Circulatory and Respiratory System, and Anticancer. This report provides a full review of the company's activities together with sales forecasts for key products to 2010.

Shionogi's consolidated net sales for the nine months ending December 2005, were ¥151,899 million, static compared to the previous year's nine-month period. Operating income was ¥24,590 million, up by 8% and net income was ¥20,949 million, an increase of 38%. R&D expenditure was ¥23,394 million, up by 1 %. Sales for pharmaceuticals and related businesses were ¥143,369 million (+2%), with ethical drugs to ¥129,200 million (+1%), OTC and quasi-drugs to ¥5,100 million (+1%) Diagnostics to ¥2,600 million (-3%).

R&D Pipeline Overview

Shionogi's pipeline has benefited from the in-licensing and co-development of important candidate drugs:

• Duloxetine hydrochloride (LY248686), has been licensed for development in the Japanese market from Eli Lilly. Shionogi had already received approval for the indication of depression, but is still conducting additional Phase III trials.
• Irbesartan (SR47436) was licensed from sanofi-aventis and is being co-developed in Japan with Bristol Pharmaceuticals KK (BMS). Shionogi hope irbesartan can take over from Longes as the company's key hypertension treatment.
• S-0139, an endothelin A receptor antagonist, has emerged from the Shionogi-GlaxoSmithKline joint venture. It is indicated for cerebrovascular diseases and is in Phase IIa trials in Japan.

Major Products Forecast to 2010

• Flomox (Antibiotic)
• Flumarin (Antibiotic)
• Vancomycin (Antibiotic)
• Kefral (Antibiotic)
• Claritin (Respiratory)
• Dobutrex (Cardiovascular)
• Longes (Cardiovascular)
• Immunance (Anticancer)
• MS Contin (CNS)
• OxyContin (CNS)

Table of Contents

Latest Results

EXECUTIVE SUMMARY

• Introduction
• Financial Performance 2005
  • Sales and Market Position
  • Income
    • Sales, Costs and Operating Income
  • Expenditure
    • Capital Expenditure
    • Capital Expenditure by Business Area
    • Capital Expenditure by Business Area, 2005
    • R&D Expenditure
    • R&D Expenditure and Capital Expenditure
  • Divisional Performance
    • Sales by Business Area
    • Sales by Business Area
    • Operating Income by Business Area
    • Operating Income by Business Area
    • Total Assets by Business Area
    • Total Assets by Business Area, 2005
  • Geographic Performance
• Company Strategy
  • Financial Targets (Consolidated)
  • Mergers, Acquisitions and Divestitures
  • Key Agreements
  • Production
  • Employees
• Product/R&D Overview
  • Key Products
    • Recent Product Launches
    • Recent Product Approvals
  • R&D Strategy
    • Key R&D Projects
  • R&D Pipeline Overview
    • Discontinued R&D Projects
  • Sales Forecast
    • Sales of Major Products (2000A-2010E)
• Conclusions

PRODUCT PORTFOLIO/RESEARCH AND DEVELOPMENT

• Major Products, Therapeutic Areas and Sales
• Sales of Major Products, 2005
• R&D Pipeline

• Antibiotic - Products
  • Major Launched Products
  • Finibax
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Sales Forecast
    • Clinical Trials
  • Flomox
    • Sales
    • Key Markets/Indications/Formulations
    • Sales Forecast
  • Flomox Sales (2000A-2010E)
  • Flumarin
    • Sales
    • Key Markets/Indications/Formulations
    • Sales Forecast
  • Flumarin Sales (2000A-2010E)
  • Kefral
    • Sales
    • Key Markets/Indications/Formulations
    • Sales Forecast
  • Kefral Sales (2000A-2010E)
  • Vancomycin
    • Sales
    • Key Markets/Indications/Formulations
    • Sales Forecast
  • Vancomycin Sales (2000A-2010E)
  • Avelox (BAY 12-8039)
  • Seftem/Cedax
• Antibiotic - R&D
  • S-013420
• Antibiotic - Summary
  • Growth Potential
  • Limiting Factors
• Circulatory and Respiratory System - Products
  • Major Launched Products
  • Claritin
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Competitor Products
    • Sales Forecast
  • Claritin Sales (2000A-2010E)
  • Crestor
    • Key Markets/Indications/Formulations
    • Competitor Products
    • Safety Issues
    • Sales Forecast
    • Clinical Trial Results
  • Dobutrex
    • Sales
    • Key Markets/Indications/Formulations
    • Sales Forecast
  • Dobutrex Sales (2000A-2010E)
  • Longes
    • Sales
    • Key Markets/Indications/Formulations
    • Competitor Products
    • Sales Forecast
  • Longes Sales (2000A-2010E)
  • Landel
• Circulatory and Respiratory System - R&D
  • Irbesartan
  • Pirfenidone
    • Clinical Trial Results
  • S-0139
  • S-5751
• Circulatory and Respiratory System - Summary
  • Growth Potential
  • Limiting Factors
• Anticancer - Products
  • Major Launched Products
  • Imunace
    • Sales
    • Key Markets/Indications/Formulations
    • Sales Forecast
  • Imunace Sales (2000A-2010E)
  • Uromitexan
  • Aqupla
• Anticancer - R&D
  • Cetrorelix
• Anticancer - Summary
  • Growth Potential
  • Limiting Factors
• Central Nervous System - Products
  • Major Launched Products
  • MS Contin
    • Sales
    • Key Markets/Indications/Formulations
    • Competitor Products
    • Sales Forecast
  • MS Contin Sales (2000A-2010E)
  • OxyContin
    • Sales
    • Key Markets/Indications/Formulations
    • Further Development
    • Competitor Products
    • Sales Forecast
  • Oxycontin Sales (2000A-2010E)
  • Morphine Hydrochloride (MH-200/MH-15E)
  • Others
• Central Nervous System - R&D
  • Duloxetine (LY248686)
  • S-0373
• Central Nervous System - Summary
  • Growth Potential
  • Limiting Factors
• Other - Products
  • Ulgut
  • Tamiflu
  • Fulmeta
  • Hormone Products
  • Biological Products
• Other - R&D
  • Cetrorelix
  • S-2367

APPENDIX 1 - FINANCIAL PERFORMANCE

• Full Year Results 2005
  • 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

APPENDIX 2 - KEY CORPORATE EVENTS

APPENDIX 3 - KEY AGREEMENTS

• AstraZeneca
  • 16th May 2002
• Bayer
  • 17th October 2005
• Bristol-Myers Squibb/sanofi-aventis
  • May 1996
• Eli Lilly
• Enanta Pharmaceuticals Inc
  • 27th July 2004
  • 14th March 2005
  • 20th December 2005
• GlaxoSmithKline
  • 19th October 2001
  • 1st April 2003
• Kyowa Hakko Kogyo Ltd
  • 17th October 2002
• Marnac Inc/KDL Inc
  • 5th November 1996
• Peninsula Pharmaceuticals Inc
  • 26th May 2003
• MundiPharma BV
• Purdue Pharma LP
  • 10th January 2006
• Roche
  • 22nd January 2001
• Schering-Plough
  • 19th January 2001
  • 16th November 2004
• Licensing

• Discontinued Agreements
  • Pfizer
    • 1st July 2005

APPENDIX 4 - INFRASTRUCTURE

• Research and Development Facilities
• Manufacturing Facilities

APPENDIX 5 - MAJOR PHARMACEUTICAL SUBSIDIARIES/JOINT VENTURES

• Subsidiaries
  • Domestic Wholly-Owned Subsidiaries
  • Overseas Wholly-Owned Subsidiaries
• Joint-Venture Companies

APPENDIX 6 - PRODUCT INDEX