Information Meeting. March 2, 2007 エーザイ株式会社. Eisai Co., Ltd.

Transcription

1 1 Information Meeting March 2, 2007 エーザイ株式会社 Eisai Co., Ltd.

2 2 Safe Harbor Statement Materials and information provided during this presentation may contain socalled forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and results to differ materially from these statements. Risks and uncertainties include general industry and market conditions, and general domestic and international economic conditions such as interest rate and currency exchange fluctuations. Risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, technological advances and patents attained by competitors; challenges inherent in new product development, including completion of clinical trials; claims and concerns about product safety and efficacy; obtaining regulatory approvals; domestic and foreign healthcare reforms; trends toward managed care and healthcare cost containment; and governmental laws and regulations affecting domestic and foreign operations. Also, for products that are approved, there are manufacturing and marketing risks and uncertainties, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials, and failure to gain market acceptance. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

3 3 Today s Theme - Goals of Dramatic Leap Plan - I. Improvement in R&D Productivity II. Redefining Globalization III. Entry into Oncology Area IV. Return to Shareholders and Progress

4 I. Improvement in R&D Productivity 4

5 5 Improvement in R&D Productivity 1. Focus on Two Franchise Areas - Neuroscience and Oncology 2. Promote Research in Frontier Areas - Immunology and Vascular Biology, etc. 3. Pursue Niche Areas Where Unmet Medical Needs Exist 4. Maintain Autonomy of Discovery Unit

6 Improving Discovery Capability Tsukuba Laboratories - Established new Innovative Chemistry Laboratories Promote innovation in chemistry by combining compound design and cheminformatics - Function as the discovery hub Expand and Strengthen Eisai Research Institute of Boston Inc. - Increased the space from 50,000 sq. ft. to 200,000 sq. ft. with $65 million investment - Enhance ADME capability - Increase number of staffs to 250 people - Chemistry Driven, Target Oriented Double the capacity of London Labs - Expand compound optimization facility in European Knowledge Center campus - Double number of researchers when combined with those at University College London to 100 people - Specialize in Neuro Science KAN Research Inst. Moved to Kobe - Enhance networking among researchers by utilizing the merits of biocluster - Continuously acquire knowledge and advanced technologies of state-of-the-art medicine and basic biology, and conduct translational research - Specialize in cellomics Tsukuba Laboratories Eisai Research Institute European Knowledge Center (Image) Kan Research Institute 6

7 7 Enhance Global Clinical Capability Increase clinical research staff 680 employees (Japan: approx. 250, US: approx. 320, Europe: approx. 110); increased approx. 120 employees year on year Establish Eisai Clinical Research Singapore Pte. Ltd Improve clinical management in Asia Realize simultaneous filing of applications globally Promote earlier NDA submissions in Eastern Asia except Japan, Southeastern Asia, India, Australia Support clinical research groups in each Asian subsidiary

8 8 Enhance Project Management Capability Project management by Eisai R&D Management Company is well under way Direct management of 46 projects Sharing of goals, single management vision Decision-making by all officials responsible for R&D functions with participation from marketing, regulatory and safety management Setting annual objectives for each project team and checking on the progress Completed LPI of Subpart H study for E7389 and set a detailed plan toward submission Launched task force on E2007 submission in US and EU

9 9 Well Prepared to Contribute to Patients Via R&D Results Take all possible measures to to ensure completion of of late-stage clinical trials and to to prepare for launch of of three global products: E7389, E2007, and E5564 Satisfy unmet medical needs in in Japanese market

10 Project Code E7389 eribulin Microtubule growth suppressor E2007 perampanel AMPA receptor antagonist E5564 eritlan Endotoxin antagonist T-614 iguratimod D2E7 adalimumab Aricept donepezil Well Prepared to Contribute to Patients Via R&D Results Target Indication Production Marketing Treatment Period Subpart H Breast cancer 270 submission in preparation API: Kashima Plant Target number of sales reps (3Q FY2007) NSCLC Formulation: North Japan $2,110/ 4 6 Phase Ib Prostate cancer Carolina US Cycle Cycles Phase II Sarcoma Plant, US EU Phase II Ovarian Cancer 80 Phase II in Preparation Parkinson s disease Effectively 2,379 $16/day 270 days Phase III (FY2007) API: Kashima Plant Epilepsy utilize current Formulation: sales reps of 4,670 $11/day 300 days Phase II Migraine Kawashima Industrial Neurology team; prophylaxis 5,472 $5/day 180 days Phase II Complex potential expansion days Multiple sclerosis Severe sepsis Rheumatoid arthritis Rheumatoid arthritis Severe Alzheimer s disease API: Kashima Plant Formulation: Misato Plant Formulation: Purchase from Toyama Chemical Formulation: Purchase from Abbott API: Kashima Plant Formulation: Kawashima Industrial Complex Effectively utilize current sales reps of Hospital team 2B2C2P 1B1C2P (Korea, Taiwan) Promote focus on full spectrum message Patient Population (x1,000) 1, (Japan) 700 (Japan) 250 (Japan) Medication Cost $100/ 2 days $7,200/ Course 6 days/ Course Phase (Filing Target) Phase II in Preparation Phase III (FY2009) - - Submitted - - Submitted - - Submitted Source: Eisai Patient population: prevalence in US, Europe (G5) and Japan in 2005 This table is for reference purposes only. 10

11 11 II. Redefining Globalization Value Creation at All Places by the Best People with the Appropriate Structure

12 12 Establish and Strengthen Four Region Structure Business Units in Japan; Asia, Oceania and Middle East; North America; and Europe Establish and strengthen the planning, marketing, legal, business development and human resource functions at each regional headquarters

13 Government - Industry Dialog in Japan Prime minister Abe places top priority on pharmaceuticals in his policy speech on Diet Government-Industry Dialog for discovery of innovative new drugs Create unified methodology for budget allocation to basic science prioritization (Japanese version of NIH (US) or OSCHR (UK) Policy needed to cultivate bioventures Promote translational research between academia and industry Streamline environment of clinical trials Expand infrastructure related to clinical trials Develop clinical trial hub site Promote clinical trial networks Resolve drug lag Expedite review and approval of applications by PMDA Promote mutual recognition between Japanese and overseas authorities International expansion of IP system Promote system for drug pricing based on value of innovative drugs Tax relief expansion for R&D investment Measures for global Pandemic (infectious disease) Public and private sectors will work together and play respective roles to solve issues in cooperation (Personal view of H. Naito) 13

14 Accomplishment of Patients Efficient utilization of healthcare budget Significant improvement in patient value 14 Establish Japan Business Headquarters (JBHQ) Prevention Intervention Innovation Japan Business Headquarters Diagnostics OTC Prescription Pharmaceuticals Generics Provide information, services and products under a unified strategy Creating Hope

15 Viewpoints Current situation People/ Patients Diagnostics Prescription drugs OTC Generics Medical devices Integrated information & services Approaches to Create Hope in the Lives of Healthy People and Patients Prevention Intervention Innovation Extensive promotion of healthy living with no evidence of benefit Smoking and obesity persist despite measures to manage them Healthy life, free from disease Quick remedy by switch OTC drugs Develop low cost riskassessment methods utilizing genome analysis Introduction of preventive measures Health management using nutraceuticals Develop products designed for antiaging with evidence Fixed patterns in prescribing habits Low awareness in management of lifestylerelated diseases and prevention Return to healthy state, stop progression Treatment by prescription drugs Drugs for lifestyle related disease Develop non-invasive tests for monitoring progress of disease at home Develop infrastructure such as health check database Develop infrastructure to help interpretation of test results Lag in introduction of advanced treatments Cure, recover lost functions Innovative drugs for cancer or HIV Gene therapy, antibody therapy with tailor-made design Develop nucleotides and cell vaccines Develop function recovery therapy Least invasive targeting therapy without radiation 15

16 Asia, Oceania and Middle East Business Headquarters Rapid Growth of Chinese and Indian Markets Growing Middle Income Families in China and India China Market Forecast $13.8 billion (2006) to $ $27.5 billion (2011) % in average rate it would grow by 2011 (IMS) Potential to become the 3 rd major market in 10 years Improve Operation Expanded Suzhou Plant (Investment: 2 billion) Increase sales representatives from 470 to 1,000 to cover 1,400 hospitals in the cities with population of 1 million or greater Marketing activities through information provision and educational meetings India Market Forecast $7.5 billion (2006) to $ billion (2011) % in average rate it would grow by 2011 (IMS) Potential to become the 5 th major market in 10 years Establish 4th Knowledge Creation Base Strategic expansion of Seamless Value Chain Establish Eisai Pharmatechnology & Manufacturing Pvt. Ltd, a process and formulation research and production company in Vizag (Investment: 5 billion) Establish clinical research and data management sites Establish discovery research site focusing on neglected diseases Arabian Sea Suzhou Plant Vizag Bay of Bengal *Copyright 2007 IMS Health or its affiliates, all rights reserved. 16

17 Changing Trends in US and Europe Increased price pressure US: increased healthcare costs associated with implementation of Medicare Part D 2006, the inaugural year, is considered successful 23.9 million out of 43.1 million beneficiaries are enrolled in Medicare Part D plans, 80% express satisfaction Medicare beneficiaries will increase by about 10% by nd wave of baby-boomers enroll in Medicare Part D beginning in 2010 New entry to the programs will increase by about 10% in 2007, and is expected to increase in line with the growth in number of Medicare beneficiaries thereafter 15.1 million with state government or employee/union coverage (creditable coverage) may begin migrating to Medicare Part D Concern over shortage of financial resources when 2 nd wave of baby-boomers enroll in Medicare Part D beginning in 2010 Issues related to doughnut hole (coverage gap where enrollees pay 100%) Increased price pressure because of new influence of Democrats Potential enactment of legislation that enables government to directly negotiate price in progress at end Europe: increased healthcare costs and price cuts Drastic reimbursement price cuts in countries including France, Germany and Italy Increased cross-border trade from lower-priced countries to higher-priced countries UK: Office of Fair Trading report Revision of PPRS Value-Based Pricing (2010 or later) *Source: Centers for Medicare & Medicaid Services: U.S. Department of Health and Human Services 17

18 Reinforcement of Business Structure to Achieve $4 Billion Sales in Americas Improve functions of Eisai Corporation of North America Conduct business operations under appropriate controls while actively working to achieve our key business plan targets Strengthen Value Chain in US Compliance Auditing Legal HR Discovery Eisai Research Institute Production Clinical Development Eisai Medical Research North Carolina. RTP HQ, Marketing Eisai Inc. Expansion of campus Investment: $65 MM - Formulation facility for oncology product Investment: $90 MM New office Investment: $30MM 18

19 Aggressive Business Expansion in Europe - Emergence of a Market with 500 million population - Investment in European Knowledge Center Start construction in March 2007 Total investment: 20 billion Capacity for 500 employees Establish European Knowledge Center in UK as headquarters of European operations, which consolidates all key value chain components, including HQs, discovery, clinical, production and marketing Expand presence in Europe (especially in member states of expanded EU) Expand into Portugal, Benelux countries, Poland, Czech Republic, Slovakia, Hungary and Russia Established bases in 21 countries in Europe Existing base Planned base European Knowledge Center (image) 19

20 Appropriate Setup of Key Global Function Centers Global Clinical Research Structure (US) Integrate clinical functions of Japan, US and Europe and operate under the management of Eisai Global Clinical Research with unified policy Global Medical and Marketing Services (US) Create and promote marketing strategy of global products Promote life-cycle management of global products Global Regulatory (UK) Gather and analyze global regulatory information and draft policies for response to this information Draft strategy for simultaneous filing and work with regulatory authorities in Japan, US and Europe Global HR (Japan) Draft and promote Global HR Management Strategy Develop and promote exchange of human resources based on global HR policy Data Management and Biostatistics and Analysis (India) 20

21 21 Realize Well-balanced Sales Proportion by Geographic Region Sales proportion of Japan, US, Europe and Asia to be 36 : 44 : 14 : 6 Europe 7.6 Asia 2.9 Europe 8.2 Asia 3.2 North America 42.1 Japan 47.4 Japan 44.7 North America 44.0 Asia 6 Europe 14 North America 44 Japan 36 FY2005 FY2006 (1Q-3Q) FY2011 (Dramatic Leap Plan)

22 III. Expand into Oncology Area 22

23 23 R&D Structure in Oncology Area Two discovery sites Tsukuba Discovery Research Laboratories II and Boston Laboratories Over 100 oncology researchers in total Antibody research in collaboration with bioventures Forged a partnership with Link Genomics, a drug discovery venture company, to discover antibodies in oncology area Global clinical research system centered on Eisai Medical Research Formed a global oncology team: 70 people Clinical Stage Product Name/Code Description/Mode of Action Launched/Submitted snda for oncology-supportive indication Approach Type Fragmin Prevention of deep vein thrombosis Supportive treatment Launched Prialt Severe chronic pain agent Supportive treatment Launched ONTAK lymphoma, whose malignant cells express the CD25 component of the Treatment of patients with persistent or recurrent cutaneous T-cell Interleukin-2 receptor (injection) Cytotoxic Launched Targretin Treatment of cutaneous manifestations of cutaneous T-cell lymphoma in Capsules patients who are refractory (oral) Cytostatic Launched Targretin Treatment of cutaneous lesions in patients with cutaneous T-cell lymphoma Gel 1% (Stage 1A and 1B) who have refractory or persistent disease (topical) Cytostatic Launched Panretin Treatment of cutaneous lesions in patients with AIDS-related Kaposi's Gel 0.1% sarcoma (topical) Cytotoxic Preparing for Subpart H submission E7389 Microtubule growth suppressor Cytotoxic Phase I E7070 Cell cycle G1 phase targeting agent Cytotoxic Phase I E7820 Alpha 2 integrin expression inhibitor Antiangiogenesis Phase I E7080 VEGF receptor tyrosine kinase inhibitor Antiangiogenesis Phase I Phase I in preparation E7974 E7107 Hemiasterlin type tubulin polymerization inhibitor Novel anti-tumor agent derived from fermentation Cytotoxic Cytotoxic

24 Building Oncology Products Commercialization Structure in US 24 Enhancement realized by acquisition of oncology products and expertise from Ligand Pharmaceuticals (Total investment: $205 MM) Acquired four products: ONTAK, Targretin Capsules, Targretin Gel 1%, Panretin Gel 0.1% Obtained oncology expertise specific to oncology products in management of: Organizing academic meetings, reimbursement strategy, product logistics and regulatory affairs Enhancement of sales structure Strengthen oncology sales force in US US: Hospital team + oncology team: 150 Increase oncology sales reps to 300 Strengthen oncology sales force globally Target: Japan 100 Europe 135 (FY2011)

25 25 Production Capabilities for Oncology Products API Manufacture at Kashima Plant Completion of P1 building Investment: 2.4 billion Formulation Broke ground for production and formulation R&D facility dedicated to oncology at North Carolina campus Broke ground: November 2006 Investment: $90 million Facility area: 65,000 sq. ft. Encompasses aseptic processing suites, laboratories and other support functions P1 building interior at Kashima Plant Planned site of new oncology facility in US

26 26 IV. Return to Shareholders and Progress

27 27 Return to Shareholders and Strategic Investments 2, ( billions) 67.8% 64.6% 69.8% 68.6% 75.0% 80% 200 2, % 47.5% 48.7% 60% 150 1, , % 23.3% 22.6% 20.8% 28.9% 40.6% 40% 20% 0 0 FY2000 FY2001 FY2002 FY2003 FY2004 FY2005 FY2006 (est.) Net Income Cash and Cash equivalents Capital Expenditures/Net Income Dividend Payout/Net Income 0%

28 28 The First Year of Dramatic Leap Plan Achieved Growth as Planned ROE DPR DOE 13.0% 40.6% 5.3% B Net sales +13% 13.1% 48.8% 6.4% Net sales +11% B (net sales) 16% 50% 8% Net Sales CAGR +9% R&D CAGR +13% 1 trillion (YOY) R&D +19% OP +10% Net Income +14% R&D +15% OP+12% Net income +10% Operating Income CAGR +13% Net Income CAGR +11% FY2005 Results FY2006 Estimated FY2011 Dramatic Leap Plan