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1
Consolidated Performance
(0.0)
2.512011.014.910010.112.4Net Income
13.111382.3111.710580.398.6Gross Margin
102
99
98
107
107
105
105
YOY
FY2005 1Q
3.912017.223.415.919.5Ordinary Income
9.112152.243.1EPS (Yen)
3.812016.522.515.218.6Operating Income
7.611251.169.350.361.8SG&A Expenses
1.811014.719.914.818.2R&D Expenses
10017.724.119.724.1Cost of Sales
13.1111100.0135.8100.0122.7Net Sales
Increase(Decrease)
YOY%Results%Results
FY2004 1Q(billions of yen, %)
2Sales of Major Products
0.410225.324.8U.S.
Aciphex/ParietProton Pump Inhibitor
5.413023.518.1U.S.
AriceptAlzheimer’sTreatment
31630.70.5Asia
(0.0)991.81.8Europe
8104235226Millions of $
3.11956.33.2Japan
3.811334.130.3Total
0.21360.90.7Asia
0.61107.36.7Europe
54132219165Millions of $
1.01119.98.9Japan
7.312141.734.4Total
Increase(Decrease)
YOYFY2005
1QFY2004
1QAreaProduct Name
(billions of yen, %)
3Sales to Customers by Geographic Area
FY20051Q
13.1111100.0135.8100.0122.7Total9.011649.166.747.057.6Overseas Total1.01382.73.72.22.6Asia and Others
0.91097.710.47.89.5Europe
7.211638.752.637.145.5North America
4.110650.969.153.065.0Japan
IncreaseYOY%Results%Results
FY20041Q
(billions of yen, %)
4
FY20051Q
FY20041Q
IncreaseYOY%Results%Results
3.5116100.025.1100.021.6Sub-Total
120
134
119
139
134
101
52.6
3.2
7.2
42.2
47.4
0.3 (2.6)(2.9)Elimination/Corporation
3.8
3.3
0.1
0.5
2.7
0.2
22.5
13.2
0.8
1.8
10.6
11.9
18.6Total
Overseas Total
Asia and Others
Europe
North America
Japan
45.79.8
3.20.7
6.01.3
36.47.9
54.311.7
Operating Income by Geographic Area(Pre-royalty deduction)
(billions of yen, %)
5
810447.823511954.1226Aciphex
2613819.49513216.669Operating Income(Pre-royalty deduction)
92053.8181642.29Net Income
141965.7281723.414Operating Income
101456.733-5.423Zonegran
5413244.521910239.5165Aricept
73118100.0491117100.0418Total Revenue
IncreaseYOY%ResultsYOY%Results
FY20051Q
FY20041Q
Performance of Eisai Inc.(millions of dollars, %)
6
(21.0)(8.9)13.418.3(7.5)9.4FY20041Q
10.21.3(7.5) 10.82.712.1FY20051Q
6.912.1(2.1)4.94.816.9FY20031Q
-5.1-7.0-12.1FY20021Q
Increase(Decrease)Results
Increase(Decrease)Results
Increase(Decrease)Results
Free Cash FlowCapital
ExpenditureCash Flow from
Operating Activities
Consolidated Free Cash Flow
(billions of yen)
7
Provision of corporate concept added to articles of incorporation
1. The Company’s corporate concept is to give first thought to patients and their families, and to increase the benefits that health care provides. Under this concept, the Company endeavors to become a human health care (hhc) company.
2. The Company’s mission is the enhancement of patient satisfaction. The Company believes that revenues and earnings will be generated as a consequence of the fulfillment of the mission. The Company places importance on this positive sequence of the mission and the ensuing results.
3. Positioning compliance, the observance of legal and ethical standards, as a core in all business activities, the Company strives to fulfill corporate social responsibilities.
4. The Company’s principal stakeholders are patients, customers, shareholders and employees. The Company seeks to foster a good relationship with stakeholders and to enhance their value through making the following efforts:• Satisfying unmet medical needs, ensuring stable supply of high quality products, and
providing useful information of safety and efficacy.• Timely disclosure of corporate managerial information, enhancement of corporate value, and
proactive return to shareholders.• Ensuring stable employment, offering challenging and fulfilling duties, and providing full
opportunities for the development and enhancement of employees’ capabilities.
8
Seven out of twelve members of the Board of Directors are outside directors. The Chair of the Board was appointed from outside directors.The Chairs of the Nominating Committee, Compensation Committee and Audit Committee were appointed from outside directors. All members of the Nominating Committee and Compensation Committee are outside directors.
The New Corporate Governance Structure
Tadashi Kurachi: Chair of the Board (Representative Director and Chairman, Kanematsu Corporation)Ikujiro Nonaka: Chair of the Nominating Committee (Professor, Hitotsubashi University Graduate School) Stuart Meiklejohn: Chair of the Compensation Committee (Partner, Sullivan & Cromwell)Mitsuo Minami: Chair of the Audit Committee (Professor, Bunkyo Gakuin University Graduate School)Naoto Nakamura (Founder and Partner, Law firm of Nakamura, Tsunoda, Matsumoto) Tadahiro Yoshida (Chairman and President, YKK Corporation)Yoshiyuki Kishimoto (Director of Strategy of Booz Allen and Hamilton Inc.) Yuji Naito: Honorary ChairmanHiromasa Nakai: Senior AdvisorTadashi TemmyoShintaro KataokaHaruo Naito: President and CEO (Representative Executive Officer)Notes: Blue letters shows the outside directors.
9
Discovery Development ManufacturingSales
&Marketing
Pharmaco-vigilance
Fulfillment of
Unmet Medical
Needs
Safe UsageofDrugs
Stable Supplyof
Quality ProductsPatients
Seamless Value Chain
Logistics
10
Reinforcing Seamless Value Chain
Restructuring P-1 plant in Kashima for preparing drug substance of E7389.
Construction of the second production site in Suzhou Plant (China) corresponding to increasing sales in China.Expansion of Eisai Research Institute of Boston, Inc. (US)
Eisai Research Institute of Boston, Inc.
11Progress of Global BusinessEntering Switzerland (June) and four Nordic countries (July, Sweden)The launch of Zonegran (zonisamide: anti-epileptic agent) will expand the business in EU.• Launched in UK and Germany in June. Planning to
launch in other countries.• Expanding indications such as monotherapy for adult
partial seizures, migraine prophylaxis, and childhoodepilepsy, etc.
• Potential sales including additional indicationsis 200 M Euro.
Reinforcing our presence in Neurology by launching Inovelon (rufinamide: anti-epileptic agent)• Marketing Authorization Application to European
Medicines Agency as adjunctive therapy for Lennox-Gastaut Syndrome (LGS) was submitted in March.
In India, Aricept and Pariet will be launched. (September)
EU market coverage: 83% (Euro volume)• Ranging from UK to France, Germany, Spain, Italy, Ireland,
Austria, Switzerland, Sweden, Norway, Denmark and Finland.
12Opportunities in Key Areas/Countries
US Sales
EU market coverage 83% (Euro volume)
The first Japanese pharma company in
India
FY2000 FY2004
CAGR: 20.5%¥101.8 B
¥214.5 B
FY2000 FY2004
CAGR: 27.9%¥14.3 B
¥38.3 BEU Sales
Consecutive double-digit growth since
1996 in US
FY2000 FY2004
¥4.6 BCAGR: 26.8%
¥11.9 BAsia Sales
Japan Sales
Net Sales (Overseas) Operating Income BeforeRoyalty Deduction (Overseas)
FY2000 FY2004
¥120.7 B
¥264.7 B
CAGR: 21.7%FY2000 FY2004
¥14.2 BCAGR: 37.9%
¥51.3 B
FY2000 FY2004
¥241.0 B¥268.3 B
CAGR: 2.7%
The most successful Japanese pharma company in China,
rapid growth in Korea,outperforming the market growth
in Japan in recent years
13
Progress in Q1 R&DApproval, Launch•Aricept (Alzheimer’s Disease)
-Approved as orodispersible tablet in UK (May)-Launched orally disintegrating tablet in US (June)
•Zonegran (Anti-epileptic agent):-Launched in June as adjunctive therapy for partial seizuresin adults (UK and Germany)
•D2E7: Psoriasis vulgaris (Japan)
•Cleactor (Anti-thrombolytic agent) -Additional indication for acute pulmonary embolismLaunched in July (Japan)
Phase II•E2007: Phase IIb indicated for migraine prophylaxis
Withdrawn•Cleactor: Cerebrovascular embolism (Phase II)
14Progress of Major Clinical TrialsE2007 AMPA-receptor antagonist
•Parkinson: Briefing Book for discussion about Phase III was submitted to EMEAEnd-of-Phase II meeting with FDA being scheduled
•Epilepsy: Phase IIb (POC)•Migraine: Phase IIb (POC)•Multiple Sclerosis: POC study plan is drafted
E7389 Microtubule growth suppressor•Breast cancer monotherapy (3rd line): Independent reviews are underway for 35 evaluable cases,
and 9 PRs were reported (4 confirmed, 5 unconfirmed)End-of-Phase II meeting with FDA scheduled in September
•Non Small Cell Lung Cancer monotherapy (2nd line): Independent reviews are underway for 52evaluable cases, and 5 PRs were reported (2 confirmed, 3 unconfirmed)
E5564 (eritoran) Endotoxin antagonist•Sepsis: Data analysis to be completed in early August
E7070 (indisulam) Cell-cycle G1 phase targeting agent•Breast cancer monotherapy: Discontinued•Colorectal & breast cancer combo therapy: Enrollment stopped.•Small cell lung cancer: Additional Phase I in preparation in combination with irinotecan•Stomach cancer (Japan): Phase I/II in progress
E5555 Thrombin receptor antagonist•Four Phase I studies were completed, and safety and platelet coagulation inhibition were confirmedBleeding time was not extended
•Five drug-drug interaction studies are ongoing•POC studies will start in 4Q FY2005
Subject: Stable angina patients, Acute myocardial patientsEndpoints: Vascular intima thickness observed with intravascular echogram
Inflammation marker (CRP:C-Reactive Protein etc.)Cardiac events
15
Submissions for NDA/MAA in 2006E7389E2007Target
Microtubule Growth SuppressorAMPA Receptor AntagonistMode of Action
–Breast cancer: 3rd + 2nd + 1st line (2006)–NSCLC: 2nd/3rd + 1st line–Soft tissue sarcoma: 2nd + 1st line–Prostate cancer: 2nd line–Ovarian cancer: 2nd + 1st line
–Adjunctive therapy with levodopa for Parkinson’s disease (PD; 2006)–Epilepsy–Multiple Sclerosis (MS)–Migraine prophylaxis
Indication
Effective for taxane refractory tumorsSimilar to or better than MAO-B inhibitor and COMT inhibitor in shortening OFF time (PD)
Efficacy
–No severe peripheral neurotoxicity–Fewer hypersensitivity reactions (no need for premedication with steroid or anti-histamine)
–Excellent safety profile–No worsening of dyskinesia (PD)Safety
No major drug-drug interactionsNo major drug-drug interactionsDrug Interactions
Bolus (5-minute IV)Day 1, 8, 15, every 4 weeksOnce a day, oral administrationAdministration
Vials (solution)Small tabletsFormulation
16
New Indications and Formulations in Development for Aricept and Aciphex/Pariet
Phase I (US)
Phase III (Japan)
Filed in March 2005 (Japan)
Phase I (US)
Phase III (US)
Plan to file in August 2005 (US)Plan to file in August 2005 (US)Plan to file in 3Q FY2005 (EU, JP)
Plan to submit additional data to FDA and resubmit in EU (FY2005)
Status
Sustained release formulation
Non-erosive GERD
Vascular dementia
AriceptAlzheimer’sTreatment
SevereAlzheimer’s disease
Mild cognitive impairment (MCI)
H. Pylori eradication
Indications FormulationsProducts
Extended release formulation
Aciphex/Pariet
Proton Pump Inhibitor
17
Neurology Pipeline
E2007: Planning Phase IIbMultiple screlosisE2014 (Botulinus toxin): Phase II bridging study (Japan)
Aricept: Dementia with Parkinson’s disease, Planning to file in FY05 (EU)Agilect (rasagiline): Filed (US, Teva)E2007: Preparing for Phase III (US, EU), Phase I (Japan)
Zonegran: Preparation for clinical studies of monotherapy (EU)Inovelon (rufinamide): Filed Lennox-Gastaut Syndrome (EU)Preparation for filing Lennox-Gastaut syndrome and adult partial seizures (US)E2007: Phase II
Aricept: Completed Phase IIE2007: Phase IIZonegran: Preparation for Phase II
Aricept: Phase III (US)
Aricept: Planning to re-file (EU) and submit additional data in FY05 (US)
Aricept: Planning to file for severe Alzheimer’s disease in August 2005 (US) in 3Q of FY05 (EU and Japan)Aricept: Launched orally disintegrating tablet (US), approved (UK)Agilect (rasagiline): Phase II (US)Aβ modulator: Discovered candidate compound (E2012), planning IND in FY05
Pipeline
Vascular dementia
Migraine (Prophylaxis)
Cervical dystonia
Parkinson’s disease
Epilepsy
Mild cognitive impairment
Alzheimer’s Disease
Disease
Blue letters: Progression in 1Q of FY 05
18Cancer Agents in Clinical Development
Patient enrollment is almost complete (JP)Safety assessment in 1-year revealed no issues
P.O.Vitamin K2Hepato-
carcinomaPhase
II/IIIE0167
Solid tumor
Solid tumor
Solid tumor
ColorectalBreast
StomachSCLC
BreastNSCLC
Cancer Type
I.V.
P.O.
P.O.
I.V.
I.V.
Route
Patient enrollment for breast cancer monotherapy is nearly completed. Good response was confirmed. End-of-Phase II meeting with FDA scheduled in SeptemberPhase I in preparation (JP)
Microtubule growth suppressorPhase IIE7389
Patient enrollment was stopped in Phase II combination studies with irinotecan for colorectal cancer and with capecitabine for breast and colorectal cancer.Phase I/II monotherapy for stomach cancer in progress (JP)
Cell-cycle G1 phase targeting
agentPhase IIE7070
Phase I in progress (US)Alpha-2 integrin expression inhibitorPhase IE7820
Phase I in progress (US, EU)Phase I in preparation (JP)
VEGF receptor kinase inhibitorPhase IE7080
Phase I in progress (US)Hemiasterlin type
tubulin binding inhibitor
Phase IE7974
Phase Current StatusMode of ActionProject
Blue letters: Progress in 1Q FY2005
19
Effective in patients resistant to existing Botulinus toxin Botulinus toxinE2014 (Cervical dystonia)
Phase I
Phase II
Preparing Phase III
Phase II/III
Phase III
Filed for approval
Stage
Reduction of off-time in PD as adjunct therapy with levodopaExcellent safety profile; no worsening of dyskinesiaAMPA receptor antagonistE2007
(Parkinson’s disease)
Less rebound than existing anti-viral agentHBV polymerase inhibitorClevudine(Hepatitis B)
Better anticancer efficacy than taxanesGood tolerability, less neurotoxicity
Microtubule growth suppressorE7389 (Cancer)
Different anticancer spectrum from existing cytotoxicsG1 Phase targetingE7070 (Cancer)
Reduce mortality and morbidity; good safety profileEndotoxin antagonistE5564 (Sepsis, CABG)
Dual action of anti-platelet and smooth muscle cell proliferation inhibition
Thrombin receptor antagonist
E5555 (Prevention of major cardiac events)
Survival benefit due to chronic tumor growth suppressionα2 integrin suppressorE7820 (Cancer)
Survival benefit due to chronic tumor growth suppressionVEGFR kinase inhibitorE7080 (Cancer)
Effective in multi-drug-resistant tumorsTubulin inhibitorE7974 (Cancer)
Reduce recurrence of hepatocellular carcinomaVitamin K2E0167 (Hepatocellular
carcinoma)
Strong and long-lasting efficacy for RA symptomsAnti-TNF antibodyAdalimumab(Rheumatoid arthritis)
Natural body weight loss based on dual actions of appetite suppression and energy consumption increase
Serotonin/Noradrenarin reuptake inhibitor
Sibutramine(Obesity Management)
Similar efficacy to salazosulfapyridine, a standard drug for RABetter safety profile with fewer severe adverse effects
Cytokine/Immunoglobulin suppressor
Careram® - igratimod(Rheumatoid arthritis)
Neuroprotective effect (Phase II for AD ongoing)Better safety profile than other MAO-B inhibitorsMAO-B inhibitorAgilect® - rasagiline
(Parkinson’s disease, Teva)
Adjunctive therapy for Lennox-Gastaut Syndrome, a severe disease with high unmet medical needs, and adult partial seizures
Na+ channel modulatorInovelon® - rufinamide(Epilepsy)
Target ProfileMode of ActionProject
Expanding Pipeline(New Molecular Entities)