1Q FY2009. (Fiscal Year Ending March 31, 2010) Financial Results Presentation. July 31, 2009

Transcription

1 1 1Q FY2009 (Fiscal Year Ending March 31, 2010) Financial Results Presentation July 31, 2009

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 1Q Consolidated Performance (GAAP) (Billion Yen, %) 1Q FY2008 1Q FY2009 Results % Results % YOY Net Sales Cost of Sales Gross Profits R&D Expenses SG&A Expenses Operating Income Ordinary Income Net Income *The above consolidated financial results calculated on a GAAP basis include the accounting treatment for business combinations applied in accordance with the acquisition of MGI PHARMA Included in 1Q results: Cost of Sales: Amortization of sales rights 4.2 billion yen R&D Expenses: Amortization of technology assets 200 million SG&A Expenses: Amortization of goodwill 2.2 billion 3

4 Products Aricept Alzheimer s Disease Treatment AcipHex / Pariet Proton Pump Inhibitor Anti-ulcer Agent Oncology - related products Sales of Major Products Area 1Q FY2008 1Q FY2009 Results % Results YOY % Japan 19.4 (26.7) U.S $ Million [415] [438] [106] Europe Asia Total Japan 11.0 (27.0) U.S $ Million [248] [203] [82] Europe Asia Total Total (Billion Yen, %) 101 [108] (31.3) 38.4 (36.5) 10.1 [ ] Impact of exchange rate excluded; ( ) are % within the product 4

5 Sales to Customers by Geographic Area (Billion Yen, %) 1Q FY2008 1Q FY2009 Japan JBHQ North America Results % Results % YOY Europe [101] 90 [114] China [130] AOME Overseas Total 81 [100] Total AOME: Asia, Oceania and the Middle East JBHQ figures are the total of the prescription drugs, OTC, diagnostic and generic business segments [ ] Impact of exchange rate excluded 5

6 6 Operating Income by Geographic Area (GAAP) 1Q FY2008 1Q FY2009 (Billion Yen, %) Results % Results % YOY Japan North America Europe China AOME Overseas Total Elimination/ Corporate Total

7 1Q FY2008 1Q FY2009 AcipHex Oncol ogy Performance of U.S. Pharmaceutical Business (Eisai Inc. + MGI PHARMA, US GAAP Base) ($ Million, %) Results % Results % YOY Net Revenue Aricept Aricept + AcipHex Aloxi Dacogen Gliadel Others MGI Total Lymphoma Products, etc. Total Fragmin Total Operating Income Operating Income (before royalty deduction)

8 8 Aim of Eisai Product Creation Systems (EPCS) Maximize Product Development Efficiencies From Discovery to Marketing Clearance

9 9 Level of Innovativeness Expressed by Shortening of Development Time - Discovery of truly innovative substances - Most modern screening systems - Best safety and ADME research in terms of predicting clinical results - Timely provision of high quality clinical drug products - Cutting edge biomarkers and imaging capabilities that improve translational research - Best efforts to conduct efficient clinical studies in terms of speed and scale - Well-crafted regulatory strategies - Appropriate go/ no go decision-making Results in Shortening of Product Development Time

10 Overview of EPCS 7 Discovery Areas 6 Technology Function Areas Neuroscience PCU Oncology PCU Morphotek PCU Frontier PCU Premier PCU KAN PCU Clinical Research Center PCU CEO Chief Product Creation Officer (CPCO) Office Pharmaceutical Science & Technology CFU Biomarker & Personalized Medicine CFU Scientific & Operational Clinical Support CFU Next Generation Systems CFU Biopharmaceutical Assessment CFU Global Regulatory CFU Chief Scientific Officer (CSO) PCU: Product Creation Unit CFU: Core Function Unit 10

11 NME Submissions Planned for FY2009 eribulin(e7389, Microtubule dynamic inhibitor) Country/Region of Application Study Targeted for Submission Europe/U.S. Japan Switzerland/Singapore Study 305 Study 305 & Study 221 Study 211 & Study 201 Study 305 Study 221 Study 211 Study 201 Patient Enrolment 762 patients 84 patients 299 patients 103 patients Target Disease Locally recurrent or metastatic breast cancer pretreated with an anthracycline and a taxane, and refractory to the last chemotherapy regimen Advanced or recurrent breast cancer pretreated with an anthracycline and a taxane Locally advanced or metastatic breast cancer pretreated with an anthracycline, a taxane and a capecitabine, and refractory to the last chemotherapy regimen Advanced or metastatic breast cancer pre-treated with an anthracycline or a taxane Control Drug Physician s Choice of Drug None None None Primary Endpoint for Efficacy Overall Survival Response Rate Response Rate Response Rate Country/Region of Clinical Study Europe, North/South America and others Japan U.S./Canada/ Europe U.S. Number of cases (411 patients) necessary for the final analysis of Study 305 has been reached, with preparations for database lock at the end of August progressing smoothly MAA submission made using data primarily from Study 211 in Switzerland and Singapore (July 2009) Acceptance confirmed by Swiss regulatory authority. Awaiting confirmation of acceptance from Singapore authority. Study 209 (comparative study of neuropathy events in comparison with ixabepilone) is ongoing Simultaneous NDA/MAA submissions in Japan, U.S. and Europe are planned for 4Q FY

12 NME Submissions Planned for FY2009 eritoran tetrasodium (E5564, Endotoxin antagonist) Progress of Phase III Trials (Study 301) Steady Patient Enrollment All study sites in 24 Countries are now open (North & South America, Europe, Asia and others) 1200 patients enrolled (As of July 2009) Safety review of 1100 patients by Data Monitoring Committee (DMC) planned for early August Interim efficacy analysis scheduled at 1500 patients; once all subjects completed, simultaneous NDA/MAA submissions to be made in Japan, the U.S. and Europe with data from Study 301 Submission Strategy Designation of fast-track approval in the U.S. Preparations for launch of first in class drug for treatment for severe sepsis by Global Launch Team are underway Establish positioning of the drug as a new mechanism of action TLR-4 antagonist, and early suppressor of formation of inflammatory cytokine Considering seeking incorporation of eritoran into the varying severe sepsis standard treatment guidelines in key countries. Simultaneous NDA/MAA submissions in Japan, the U.S. and Europe planned for 4Q FY

13 13 Pipeline Product to Increase Patint Benefits E5555 (Thrombin receptor antagonist) Progress of Phase II Trials (Studies 201, 202, 206, 207) Acute Coronary Syndrome Study 202 (US/ Europe) Enrollment of 600 patients (Feb 2009) LPO (last patient out) completed (Jun 2009) Study 207 (Japan) LPI (last patient in) completed (May 2009) Atherothrombosis Study 201 (US/ Europe) LPI completed (Jan 2009) Study 206 (Japan) LPI completed (Sep 2008) and LPO completed (Mar 2009) Next Steps Database Lock of each study is expected in Q2/Q3 FY2009 Phase III study design will be fixed after consultation with health authorities Submission of marketing authorization applications for Acute Coronary Syndrome planned for FY2012

14 Japan Business Continued High Growth through Eisai s Unique Integrated Four Businesses Pharmaceutical Business grew 12%, exceeding market growth by 6 points* Eisai s sales ranking in Japan rose one position from the previous year to rank 7 th * Aricept was ranked 5 th and Pariet 12 th in the April to June (cumulative) product ranking* Sales of generic products during the 1 st quarter grew rapidly, reaching 1.5 times the figures of the previous year Aricept penetration rate for the 1 st quarter increased by 3.8 points from previous year, reaching 53.8% Received approval for a new oral jelly formulation of Aricept on July 13 th Aim to achieve sales of 96 billion yen (123% YOY) in FY2009 Market share of Pariet in the 1 st quarter among PPI s increased by 1.3 points from the previous year, reaching 32.6% Disease awareness-raising activities, such as national newspaper ad and insert campaigns, led to increased website access (440,000), and greater disease awareness among patients. Aim to achieve sales of 52 billion yen (117% YOY) in FY2009 Source: IMS Japan, JPM Apr Jun

15 15 Japan Business Favorable Progress in Development of New Products for Japanese market Humira Continued careful surveillance of cases giving the highest priority to safety of patients Post Marketing Surveillance to promote appropriate use is on going. Results of analysis of 3000 cases will be announced before the end of the fiscal year Pursuing the benefit of self-injection at home following July removal of restriction on long term dose pack Strive to achieve sales of 7.5 billion yen in FY2009 Obescare Capsules 10mg (Anti-obesity Agent: KES524: Passed by 1 st Committee on Jul 24, 2009) Assumed indication Weight management of obese patients with a BMI of over 25kg/m 2 who have Type II Diabetes and abnormal lipid metabolism associated with accumulation of visceral fat (only for patients who don t see sufficient results through dietary measures and exercise therapy) Target patients Latent prevalence of obesity is 27 million, of which one million also have Type II Diabetes and abnormal lipid metabolism (TESTA MARKETING 2007) Contribute to patients with new products to be launched during or after FY2009 Anti-cancer agent, (breast cancer) Eribulin: MAA submission planned for FY 2009 Sepsis antagonist, Eritoran: MAA submission planned for FY 2009 Cervical Dystonia agent (E2014): MAA submission made in 2006 Non-Hodgkin s lymphoma agent, bendamustine HCl (SyBL-0501): MAA submission planned for FY2009 Insomnia agent (SEP-190): MAA submission planned for FY2010 Drug-Eluting Bead products for Hepatocellular Carcinoma (DC Bead / LC Bead )

16 U.S. Business Expanding further contributions to patients with Aricept and Aciphex Aricept - 23mg SR formulation: Eisai plans to submit an NDA of the formulation which aims to increase patient benefit while maintaining the safety profile within the 1 st half of FY2009 -Once-a-week transdermal patch formulation: Teikoku Pharma USA Inc. plans to submit an NDA in the middle of FY Establishing pediatric usage: FDA declined to issue a Written Request for the application of studies. Aciphex -ER Formulation: NDA submission is planned for FY2009 aiming to make the formulation as the strongest PPI Accelerate transformation to oncology/biologics market Accounted for 23.4% of sales, up 1.7 points compared to the same period of the last fiscal year Aloxi maintains continuous growth of sales and 52% of market share in the CINV clinic market*, despite competition with multiple generics Progress Dacogen patient value programs and renew market share growth in MDS segment 5 days dosing regimen snda application, AML pediatric clinical trial, AML adult clinical study Phase III Current NCCN (National Comprehensive Cancer Network) guideline Rapid growth of Fragmin (148% YOY) with enhanced focus on promotion within oncology indication RTP oncology manufacturing facility construction will be completed in FY2009 (start production in FY2010) Aggressive investment in clinical production facility of Morphotek (approx. 7.5 billion yen) RTP Oncology Manufacturing Facility *Source: Tandem US Oncology Monitor, May 2009 MAT 16

17 17 U.S. Business Creation of a flexible sales structure to successfully launch new products on to the market starting from 2009 Banzel (Lennox-Gastaut Syndrome) Incorporated in to Medicaid plans in 29 states following its launch in January 2009 Awarded 2009 Corporate Award by the NORD (National Organization of Rare Disease) Lusedra (Sedative) Approved in December 2008 and recommended as FDA controlled substance. In July 2009, the U.S. Drug Enforcement Administration recommended it be designated as a Schedule IV drug (of five classes). Product launch is planned for 3Q FY2009, following a 30-day public comment period, and ruling on labeling. Initiation of Global Launch Team supporting up to 4 products launch during FY2010 (Aricept 23mg SR, Patch Formulation, Eribulin, Eritoran) Planning for new product strategies to create enhanced patient benefits Creating new market access strategies looking toward the evolving future environmental changes Health-economic studies being conducted in accordance with the local market needs Establishing updated pricing strategies within new and emerging markets

18 Europe Business Established European Knowledge Centre Promotion of knowledge creation through the consolidation of discovery research, clinical research, manufacturing, marketing and European headquarters functions at the European Knowledge Centre. - Opening ceremony was held on June 26 th, Production of packaging of Aricept will begin in the 1 st half of FY2009, followed by packaging for Pariet and Zonegran. Formulation production expected to begin in FY2010, this facility will be a core function in the European value chain. - Synthesis and pharmacology started in July Disposition research is expected to begin in the 2 nd half of FY2009. Establishment of an anti-epilepsy franchise with a line-up of products which have different features ZEBINIX (Novel carboxamide, inhibition of sodium channel) The European Commission granted Bial Marketing Authorization on April 21 st, Eisai is currently conducting prelaunch activities such as filing pricing & reimbursement applications in each country. Launch in Germany and the U.K. is planned for the end of September and October 2009 respectively. Zonegran (Inhibition of sodium/calcium channels, GABA receptor binding, launched in June 2005) Inovelon (Active in Lennox-Gastaut Syndrome, inhibition of sodium channel, launched in May 2007) E2007 (AMPA receptor antagonist, submission planned for FY2012) 18

19 China/ AOME Business Product Line-Up Corresponding to the Disease Structure (Main Products) GI Area - Liver disease: Stronger Neo-Minophagen C, Glycyron Tablets, clevudine, LIVACT Granules - Gastrointestinal diseases: Pariet, Selbex, Gasmotin Endo & Orthopedic area -Diabetes: Methycobal, Glufast, alpha-lipon 300 STADA -Musculoskeletal diseases: Glakay, Myonal CNS Area - Alzheimer s disease: Aricept (Additional indications for severe AD and Rapid Disintegration Tablet) - Epilepsy: Zonegran, rufinamide Oncology Area - bendamustine, eribulin mesylate Frontier Area - dysuria associated with benign prostatic hyperplasia: Urief Marketed: in blue letters Visag Plant Visag Plant, India (Under Construction) Construction of the plant is progressing as planned (inauguration in FY2009) Aim to Establish production system that enables to deliver high-quality products at low cost for all patients in the emerging area 19

20 FY2009 Financial Forecast (No Change from forecast as of May 2009) (GAAP Based) (Billion Yen, %) FY2008 FY2009 Results % Forecast % YOY Net Sales Cost of Sales Gross Profits R&D Expenses SG&A Expenses Operating Income Ordinary Income Net Income Cash Income Dividend per Share (yen) FY2009 forecast exchange rates: US$ = 95 yen (YOY -5.5%), Euro = 125 yen (YOY -12.9%), GBP = 135 yen (-22.4%) Cash income is the total amount of cash available for investments for growth, business development, dividend payment, and repayment of borrowings, etc. Cash income =Net income + Depreciation of PP&E and amortization of intangible assets + Amortization of goodwill + Loss on impairment ( including loss on devaluation of investment securities) 20