First Half Fiscal Year 2004 Financial Results. Eisai Co., Ltd.

Transcription

1 1 First Half Fiscal Year 2004 Financial Eisai Co., Ltd.

2 Consolidated Performance for First Half FY 2004 (billions of yen, %) 2 FY2003 1H FY2004 1H % % Change Net Sales Cost of sales Gross Margin R&D Expenses SG&A Expenses Operating Income Ordinary Income Net Income EPS (Yen)

3 Consolidated Performance for Second Quarter FY 2004 FY2004 1Q FY2004 2Q (billions of yen, %) 3 % % Net Sales Cost of sales Gross Margin R&D Expenses SG&A Expenses Operating Income Ordinary Income Net Income EPS (Yen)

4 Sales of Major Products 4 (billions of yen, %) Product Name Area FY2004 1Q FY2004 2Q FY2004 1H Aricept Alzheimer s Disease Total Japan U.S Treatment Millions of Dollars Europe Asia Aciphex/ Pariet Proton Pump Inhibitor Total Japan U.S. Millions of Dollars Europe Asia The average dollar rate during first half of FY2004 was yen and that during first half of FY2003 was yen.

5 Sales to Customers by Geographic Area 5 (billions of yen, %) FY2003 FY2004 1H 1H % % Change Japan North America Europe Asia and Others Overseas Total Total

6 Operating Income by Geographic Area 6 (Pre-royalty deduction) FY2003 1H FY2004 1H (billions of yen, %) % % Change Japan (5.5) North America Europe Asia and Others Overseas Total Sub-Total (1.7) Eliminations (5.5) (3.2) 2.3 Total

7 Performance of Eisai Inc. (millions of dollars, %) 7 FY2003 1H FY2004 1H % % Change Net Sales Aricept Aciphex Zonegran Operating Income Net Income Operating Income (Pre-royalty Deduction)

8 8 Consolidated Free Cash Flow (billions of yen) Cash Flow from Operating Activities Capital Expenditure Free Cash Flow Change Change Change FY2002 1H 19.6 (13.6) (14.2) (3.9) 5.3 (17.5) FY2003 1H (9.8) FY2004 1H 40.8 (5.1) (24.2) (14.3) 16.6 (19.4)

9 Further Globalization 9 Established European Regional Headquarters Eisai Europe Limited Expand into new markets and strengthen management Current Operations India EU Established a subsidiary in India Eisai Pharmaceuticals India Private Limited Functions include filing for approval, clinical development, consignment of manufacturing, promotion and marketing products, and importation of drug substance

10 U.S. Aricept Sales and Prescription Growth Trends ( %) 10 April to June 2004/2003 July to September 2004/2003 April to September 2004/2003 Sales NRx TRx ( Source: IMS NPA Plus, Retail, Sales comparison is based on dollar figures)

11 U.S. Aciphex Sales and Prescription Growth Trends ( %) 11 April to June 2004/2003 July to September 2004/2003 April to September 2004/2003 Sales NRx TRx ( Source: IMS NPA Plus, Retail, Sales comparison is based on dollar figures)

12 Steady Growth of Japanese Business 12 Growth Rate Sales growth rate in Japan April-September 2004, IMS Prescription pharmaceuticals in Japan Market share by sales Market Average 102.6% Market Share 1H FY % Eisai 106.6% 1H FY % April-September 2003 and 2004, IMS Ranking of Manufacturers Prescription pharmaceuticals in Japan FY2003 8th 1H FY2004 7th April 2003-March 2004, April-September 2004, IMS

13 13 Achievement of Pariet in Japan 1. Established as the top branded PPI in university hospitals 2. Consistent acid suppression and therapeutic efficacy, demonstrated in data 1) The therapeutic effects of rabeprazole at a dose of 10mg on reflux esophagitis may not be influenced by CYP2C19 polymorphism Authors: Ken Ariizumi et al, Japanese Journal of Gastroenterology. 101(Suppl.) A193, ) The therapeutic effects of rabeprazole in patients with H. pylori positive or negative gastro-esophageal reflux disease Authors: Toshihito Saitoh et al, Japanese Journal of Gastroenterology. 101(Suppl.), P021, ) Anti-gastric acid secretion effects of three proton pump inhibitors (rabeprazole(10,20), omeprazole(10,20), lansoprazole(15,30)) Authors: Tomohiko Shimatani et al, the Journal of Japanese Society of Gastric Secretion Research, 36, 55-58, More patients with GERD identified through ongoing educational efforts

14 Growth Strategy for Pariet in Japan - To Be Most Preferred Branded PPI by Patients Expand market by educating patients about GERD Promote the diagnosis of GERD by utilizing FSSG interview sheet Promote the diagnosis and evaluation of treatment efficacy by using VAS Educate patients via web broadcasting Educate patients via mass media 2. Gain share in the PPI market Increase medical reps (1,200 MRs) in FY2005 Establish prescription and treatment guideline by each department in hospitals Present efficacy and safety data based on comparative evidence Gaining market share in PPI Market FY B FY B 3. Seek further product potential through additional indications H. pylori eradication (submission is expected in FY2004) Non-erosive GERD (submission is expected in FY2005) Expand market by educating patients about GERD FSSG: Frequency Scale for the Symptom of GERD VAS: Visual Analogue Scale

15 Newly Launched Products In First Half FY2004 Zonegran (Epilepsy) April 28, 2004, U.S. 15 Aricept D Tablets (Rapid Disintegrating Tablet) July 1, 2004, Japan Apnission Inj. (Apnea in Premature infants) July 1, 2004, Japan Neophyllin Inj. prefilled soft bag 250mg (Additional Formulation) July 1, 2004, Japan Warfarin 0.5mg Tablet (Additional Formulation) May 10, 2004, Japan

16 16 U.S. Zonegran Zonegran was transitioned smoothly from Elan to Eisai. 90 Elan sales personnel joined Eisai upon deal execution. Zonegran sales have been booked by Eisai Inc. since April 28th and achieved $56 million in first half FY2004 (five months). Zonegran off to a strong start for FY2004 sales target of $110 million. Zonegran contributed to an increase in profit even after absorbing amortization costs. Epilepsy will be a therapeutic area of focus with Zonegran, Cerebyx, rufinamide, and E2007. Zonegran was filed for approval under the centralised procedure in the E.U. in November 2003.

17 Regulatory Achievements In First Half FY2004 Approved Pariet - On-demand therapy of symptomatic GORD - Amendments to the Posology and Method of Administration (EU, April) - Zollinger-Ellison Syndrome - Additional indication (EU, June) Aricept - Orally Disintegrating Tablet - Additional formulation (US, October) - Liquid - Additional formulation (US, October) Coretec - Prefilled softbag -Additional formulation (Japan, September) 17 Submitted Zonegran (E2090) - Application was transferred from Elan (EU, April) - Application was submitted in November, 2003 Aricept - Liquid - Additional formulation (EU, May) Blue: Achievements during second quarter FY2004 and subsequent events

18 Advances in Development Phase In First Half FY Phase III KES524 (generic name: sibutramine) Phase III initiated (Japan) Pariet Non-erosive GERD Phase III initiated (Japan) Phase II TVP-1012 (generic name: rasagiline) Phase II initiated (US) Alzheimer s disease (additional indication) E7389 Cancer/Breast Cancer Phase II initiated (US) E7070 Cancer/Gastric Cancer Phase I/II initiated (Japan) New Compound Ravuconazole - Triazole-type antifungal agent originally synthesized by Eisai - Initiate an independent development program for ravuconazole upon termination of the licensing agreement with BMS Discontinued E3309 H. pylori eradication Phase I: Contract expiration resolved Blue: Achievements during second quarter FY2004 and subsequent events Excludes compounds that have not changed phase in first half FY2004.

19 Advances in Development Phase -Newly Initiated Clinical Studies- 19 TVP-1012 (rasagiline) E3030 E7080 E3024 Alzheimer s disease (additional indication) Irreversible monoamine oxidase type B (MAO-B) inhibitor Diabetes Control glucose level by dual agonizing PPAR alpha-gammma Cancer Diabetes Indication Oral angiogenesis inhibitor (VEGFR tyrosine kinase inhibitor) Control glucose level by inhibiting DPP (dipeptidyl peptidase) IV Phase II initiated (US) Status Phase I initiated (US, Japan) Phase I in preparation (US, EU) Phase I in preparation (Japan)

20 Key Global POC Projects 20 E2007: AMPA Receptor Antagonist Parkinson s disease Epilepsy Multiple Sclerosis Region EU US EU Stage Phase IIb in progress Phase IIb in preparation Phase IIa completed E7070 (indisulam): Cell Cycle G1 Phase Targeting Agent Mono/Combo Region Stage Combo Breast cancer Mono Combo US EU Phase IIb in progress Phase II in preparation - capecitabine Colorectal cancer Combo Combo EU EU Phase II in preparation Phase II in progress capecitabine irinotecan NSCLC Combo EU Phase II in progress carboplatin Gastric cancer Mono JP Phase I/II initiated - Blue: Studies expected to complete POC in FY2004

21 Key Global POC Projects 21 E7389: Tubulin Polymerization Inhibitor Mono/Combo Region Stage Mono US Phase I in progress Breast cancer Mono US Phase II initiated NSCLC Mono US Phase II in preparation E5564 (eritoran): Endotoxin Antagonist Sepsis Prevention of endotoxin-related complication after coronary artery bypass graft surgery (CABG) Prevention of endotoxin-related complication after coronary artery bypass graft surgery (CABG) Region US EU EU Stage Phase II (3 rd Stage, high dose) in progress Phase IIa completed Phase IIb in progress Blue: Studies expected to complete POC in FY2004

22 Aricept Lifecycle Management 22 Vascular Dementia (US) Filing Submit Additional Data in the U.S. Re-file in the E.U. in FY2005 Severe Alzheimer s (US, EU, Japan) Phase III Filing Expected in FY2005 Dementia Associated with Parkinson s Disease (EU) Phase III Filing Expected in FY2005 Mild Cognitive Impairment (US) Phase III Migraine Prophylaxis (US, EU) Phase II Orally Disintegrating Tablet (US) Approved in October, 2004 Liquid Formulation (US) Approved in October, 2004 Orally Disintegrating Tablet (EU) Filed in 2003 Liquid Formulation (EU) Filed in 2004

23 Pariet/Aciphex Lifecycle Management 23 Eradication of H. pylori (US, EU) Symptomatic GERD (US, EU) EU 2000 US 2002 EU 2001 US 2002 Approved Approved Maintenance Therapy for GERD (Japan) Approved in 2003 On-demand Therapy for Symptomatic GORD (EU) Approved in April, 2004 Zollinger-Ellison Syndrome (EU) Approved in July, 2004 Eradication of H. pylori (Japan) Non-erosive GERD (Japan) Phase III Phase III Filing Expected in FY2004 Filing Expected in FY2005 Intermittent Therapy for Symptomatic GERD (US) Phase II

24 Global Filing Plan NME (New Molecular Entity) and LCM (Lifecycle Management) 24 FY2005 FY2004 Filed FY2006 FY2007 FY2008 E5564 (Sepsis, US and EU) E7070 (Gastric cancer, JP) E5564 (Prevention of endotoxin-related complications after coronary artery bypass graft surgery, US and EU) KES524 (Obesity Management, JP) E2007 (PD, US and EU) E7070 (Breast cancer, US and EU) E7389 (Breast cancer, US) D2E7 (Rheumatoid arthritis, JP) Aricept (Severe AD, US and EU) E2014 (Cervical dystonia, JP) Aricept (Dementia associated with PD, EU) E7210 (Contrast medium, JP) Aricept (Vascular dementia, submit additional data in US and re-file in EU) Pariet (Non-erosive GERD, JP) rufinamide (Epilepsy, US and EU) Pariet (H.pylori eradication, JP) Zonegran (E2090: Epilepsy, EU) Aricept (Orally disintegrating tablets, EU) Careram (T-614 : Rheumatoid arthritis, JP) Aricept (Liquid, EU)

25 Financial Forecast for FY (billions of yen, %) FY2003 FY2004 Estimates Net Sales R&D Expenses Operating Income (R&D Expenses + Operating Income Ratio) 30.4% 31.0% - Net Income EPS (Yen) Dividends (Yen ) DOE (%)