Information Meeting. March 9, 2018 Eisai Co., Ltd.

Transcription

1 Information Meeting March 9, 2018 Eisai Co., Ltd.

2 Safe Harbor Statement Forecast or target figures in this material are not official earnings guidance but represent midterm strategies, goals, and visions. Official earnings guidance should be referred to in the disclosure of the annual financial report (Consolidated Financial Statement) in accordance with the rules set by Tokyo Stock Exchange. Materials and information provided during this presentation may contain so-called 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; regulatory agency s examination period, 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. This English presentation was translated from the original Japanese version. In the event of any inconsistency between the statements in the two versions, the statements in the Japanese version shall prevail. The Company discloses its consolidated financial statements according to the International Financial Reporting Standards(IFRS) 1

3 Imperatives for Plan EWAY 2025 Strategic Partners and New Business Model 2

4 Strategic Partnership With Merck & Co., Inc., Kenilworth, N.J., U.S.A. A new alliance in Cancer Evolution Era has just started 3

5 Intent for Collaboration Aim to realize value creation for patients with cancer in Cancer Evolution Era through innovative business model 4

6 Summary of collaboration Aim to promptly obtain new indications through co-development of LENVIMA Initiation of new co-development of the combination of LENVIMA and KEYTRUDA simultaneously for 11 regimens in six types of cancer and multiple cancer types in a basket trial to maximize patient contribution through the synergistic effects of LENVIMA and KEYTRUDA Collaboration aiming at expansion of access for LENVIMA Eisai, who has obtained a wealth of medical data on LENVIMA, and Merck & Co., Inc., Kenilworth, N.J., U.S.A., with its strong commercial footprint and medical expertise that spans the globe, are expediting the maximization of patient access to LENVIMA through joint commercialization and clinical activities Eisai to manufacture and book sales of LENVIMA. Companies to share development and marketing costs equally, as well as profits from LENVIMA. 5

7 Changes in tumor diameter (%) Changes in tumor diameter (%) Combination Therapy Rationale Observations from Phase Ib/II study targeting seven types of cancer *1 Metastatic renal cell carcinoma (30 patients) ORR *2 : 63% Tumor response was observed regardless of PD-L1 expression *3 Endometrial carcinoma (23 patients) ORR *4 : 52.2% Tumor response was observed regardless of MSI *5 status *6 (Anti-PD-1 antibodies are associated with high response rates in patients with MSI-H or dmmr *7 tumors) PD-L1 positive PD-L1 negative Unknown Low or negative MSI status Unknown MSI status Equivocal MSI status High or positive MSI status 6 Remarkable effect observed in combination therapy, exceeding efficacy of single agent administration All projects are investigational *1: Renal cell carcinoma, endometrial carcinoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, non-small cell carcinoma, melanoma, hepatocellular carcinoma *2: Ratio of total of patients whose tumor had disappeared (complete response) and patients with tumor in which more than 30% shrinkage to the total size was observed (partial response). *3: Presented at European Society for Medical Oncology (ESMO) 2017 Congress. Lee CH, et al. A Phase 1b/2 Trial of Lenvatinib + Pembrolizumab in Patients With Renal Cell Carcinoma. Abstract No. 847O *4: Based on an independent radiologic review (IRR) *5: Microsatellite instability *6: Presented at 2017 American Society of Clinical Oncology Annual Meeting. Makker V, et al. A Phase 1b/2 trial of lenvatinib plus pembrolizumab in patients with endometrial carcinoma *7: Deficient mismatch repair

8 Approved Indications and Projects Under Review/Investigational Ongoing Projects Thyroid cancer 1 st line monotherapy Renal cell carcinoma 2 nd line combination therapy with everolimus Hepatocellular carcinoma 1 st line monotherapy* Renal cell carcinoma 1 st line* Combination therapy with everolimus or with KEYTRUDA Approved in more than 50 countries Approved in more than 40 countries Simultaneous submissions achieved in 4 global regions Phase III study ongoing Aim to expand market coverage Aim to accelerate development Aim to expand market coverage for approved indications through co-commercialization, including increase in approved countries Aim to maximize patient contribution by accelerating investigational ongoing projects through co-development 7 * Investigational

9 8 Aim to Promptly Obtain New Indications Initiate multiple clinical studies aiming at indication/regimen expansion by advancing currently ongoing Phase Ib/II study Ongoing Phase Ib/II study Study 111 Renal cell carcinoma (RCC), endometrial carcinoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, non-small cell carcinoma, melanoma Study 116 Hepatocellular carcinoma Breakthrough Therapy Designation granted by U.S. FDA for the indication of RCC Endometrial carcinoma Head and neck cancer Bladder cancer Non-small cell lung cancer Melanoma Hepatocellular carcinoma Develop multiple regimens in each type of cancer Basket trial targeting multiple cancer types Aim to realize the synergistic effect by simultaneously advancing clinical studies; renal cell carcinoma aiming at potential early approval based on granted Breakthrough Therapy designation, clinical studies for 11 regimens in six types of cancer, and a basket trial targeting multiple cancer types All projects are investigational.

10 Expansion of Access Expand access to LENVIMA through global networks of both companies Eisai global: Medical Affairs: approx.140 Oncology dedicated sales reps: approx. 540 EMEA Medical Affairs :approx. 40 Oncology dedicated sales reps: approx. 150 Japan Medical Affairs :approx. 20 Oncology dedicated sales reps*: approx. 140 US Medical Affairs: approx. 50 Oncology dedicated sales reps: approx. 120 China Medical Affairs: approx. 10 Oncology dedicated sales reps: approx. 30 Asia Medical Affairs: approx. 20 Oncology dedicated sales reps: approx. 100 Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strong commercial footprint and medical expertise that spans the globe Aim to expand access to LENVIMA through optimal resource allocation based on the agreement 9 * In addition to oncology dedicated sales reps, approx. 980 sales reps also co-operate oncology marketing

11 Forecast of Revenue and Profit for LENVIMA Revenue and profit will significantly exceed the Eisai sole development/promotion case with potential expansion of 11 regimens in six types of cancer and potential synergy effects from co-commercialization utilizing networks of both companies Accelerate development aiming for indication expansion across multiple cancer types with efficient investment in R&D Due to improvement in SG&A cost efficiency, profit of LENVIMA will significantly increase ( 億円 ) (billions of yen) 共同開発による Expansion of indications 新たな適応症の急伸拡大 Increase from the collaboration 5, 共同販促によるアクセスの拡大 Expansion of access エーザイ単独 Eisai alone (billions ( 億円 of yen) ) エーザイ単独 Eisai alone 2, FY2017 forecast FY2021 target Illustration of revenue growth simulation of LENVIMA * * Illustration based on given success case 0 FY2017 年度 forecast 見通し FY2021 年度 target 目標 2025 年度目標 Illustration of profit growth simulation of LENVIMA *

12 Launched product Halaven Microtubule dynamics inhibitor MORAb-202 Antibody-drug conjugate (ADC) E7130 *1 Halichondrin analogue Oncology Pipeline excluding Lenvima Biologics Middle molecule compound Small molecule compounds Submitted breast cancer indication in China in FY2017 Phase I/II study ongoing for triple negative breast cancer in combination with KEYTRUDA Aim for Eisai s first ADC comprising farletuzumab (MORAb-003), an investigational anti-folate receptor alpha (FRA) antibody with a payload eribulin (active ingredient of the launched, inhouse developed anti-cancer agent Halaven) Phase I study ongoing for FRA expressing solid tumors Topline results for Phase II study anticipated in FY2020 Aiming at treatment for rare cancer as a middle molecule microenvironment ameliorative agent by inhibiting microtubule dynamics: Utilizing Eisai s world-class modern synthetic organic chemistry, with the aim to create a new innovative compound like Halaven Phase I study ongoing for rare cancer E7386 *2 CBP/Beta-catenin inhibitor H3B-8800 SF3B1 modulator H3B-6527 FGFR4 inhibitor Aim to develop as a first-in-class molecular targeted agent of protein-protein interaction inhibitor that inhibits interaction of CBP/ beta-catenin located downstream of Wnt signaling pathways Phase I study ongoing for solid tumors with activated Wnt signaling pathways Frequency of spliceosome gene mutation is approx. 50% to 60% *3 in chronic myelomonocytic leukemia (CMML): Aiming for potential new treatment option as a splicing modulator in patients with hematological malignancies Phase I study ongoing for hematological malignancies with spliceosome gene mutation Topline results for Phase II anticipated in FY2019 Overexpression of driver gene FGF19 (FGFR4 ligand) in approx. 35% *3 of hepatocellular carcinoma (HCC) patients: Aim for new treatment option in patients with HCC Phase I study ongoing for hepatocellular carcinoma (HCC) with overexpression of FGF19 11 H3B-6545 ESR1 inhibitor E7090 FGFR1,2,3 inhibitor Potential to treat patients with estrogen receptor (ER) positive breast cancer, as a first-in-class estrogen receptor 1 (ESR1) covalent antagonist Phase I study ongoing for ER positive breast cancer Aim for targeted therapy based on cancer genome information Phase I study ongoing for gastric cancer with FGFR2 gene amplification and intrahepatic cholangiocarcinoma with FGFR2 gene fusion All projects are investigational. *1: Co-created compound with Harvard University *2: Co-development with PRISM Pharma *3: Internal estimates

13 Strategic Partnership With Biogen: The strongest allies for creating Alzheimer s disease (AD) treatments 12

14 Aducanumab * Phase III Program is Steadily Ongoing Blinded sample size re-estimation for ENGAGE and EMERGE was preplanned per protocol in case of variability from original assumptions As per the reevaluation of variability on the primary endpoint, sample size was adjusted as planned in order to maintain 90% study power (additional 255 patients per study: total of 1605 patients per study) The program is ongoing as planned with sample size of 1605 patients per study, which is the similar setting to other Phase III programs studying disease modifiers for Alzheimer s Disease Patient enrollment is steadily ongoing, with completion of patient enrollment anticipated in mid-2018, regardless of increase in the sample size Neither the probability of success of Phase III studies nor whole plan of the programs are impacted 13 * Investigational. Co-development with Biogen.

15 Effect of BAN2401 BAN2401 * Characteristics of A-beta Clearance BAN2401 has A-beta clearance effect by binding to A-beta protofibrils that are believed to be highly toxic A-beta protofibrils Soluble A-beta aggregates High toxicity Induce neurodegenerative process and cause neuronal cell death A-beta fibrils Insoluble A-beta aggregates Disease progression of dementia Risk of ARIA *2 Removal of brain amyloid is associated with increased the risk of ARIA Accumulation of A-beta potentially has a negative effect on dementia disease progression Binds to A-beta protofibrils Clearance of highly toxic A-beta protofibrils (soluble aggregates) Potential risk of ARIA is lower with weaker effect on for A-beta fibrils (insoluble A-beta aggregates) 14 *1: Investigational. Co-development with Biogen. Licensed in from BioArctic. *2: Amyloid related imaging abnormalities with cerebral edema (ARIA-E) or with cerebral microhaemorrhages (ARIA-H)

16 Investigational Elenbecestat *1 Pursuit of Potential as BACE1 Inhibitor in AD Treatment Relative selectivity to BACE1 is sought for BACE inhibitors for AD treatments 1. Inhibition of BACE1 is important since BACE1 is potentially related to A-beta production in brain 2. Selectivity of substrates of BACE1/2 is important since neuronal cell maintenance, synaptic formation and brain immunity may be impacted by them *2 BACE1 *4 BACE2 *4 BACE2/BACE1 *5 50% inhibitory concentration (nm)* 3 of elenbecestat Elenbecestat demonstrates relative selectivity to BACE1 Phase III Studies ongoing MISSION AD1 MISSION AD2 *6 Clinical studies underway at 421 sites *7, and plan for a total of 480 sites in FY2017 Plan to initiate clinical studies in China in March 2018 Enrollment of patients in early disease stage ongoing as planned (over 75%: prodromal, less than 25%: mild AD) Topline results for primary endpoint anticipated in FY *1: Generic name for E2609. The generic name is not yet fixed at this time. Co-development with Biogen. *2: Voytyuk et al, Life Science Alliance 2018, 1 *3: Internal data *4: Smaller number indicates stronger activity *5: Larger number indicates higher selectivity to BACE1 *6: Names of E2609 Phase III studies (AD1 is Study 301, AD2 is Study 302) *7: As of February 28, 2018

17 Parallel Progression of AD Pathology and Transformation of Symptoms of Various Aggressive Factors Total care by the combination of different mechanisms of action depending on the disease stages and symptoms of patients Disease stages Preclinical AD Prodromal AD AD Pathology of aggressive factors A-beta pathology Tau pathology Early anti-a-beta treatment BACE inhibitor + anti-a-beta antibody Treatment based on aggressive factors Prevention of onset Inhibition of progress Progression of disease Anti-A-beta maintenance treatment BACE inhibitor ±Anti-A-beta antibody (intermittent treatment etc.) Anti-A-beta treatment and anti-tau treatment BACE inhibitor + anti-a-beta antibody + anti-tau antibody Inhibition of progress Anti-A-beta and anti-tau maintenance treatment BACE inhibitor ±Anti-A-beta antibody (intermittent treatment etc) ± anti-tau antibody (intermittent treatment etc) 16 Treatment based on transformation of symptoms over time Sleep disorder Behavior disorder (epilepsy) * All projects are investigational except for Aricept *1: Co-development with Purdue Pharma Lemborexant *1 Cognitive disorder E2082 and E2730 Aricept and E2027

18 Lemborexant *1 Dual orexin receptor antagonist Phase III study in patients with difficulty staying asleep through the night *2 (Controlled study in patients age 55 years and older with active comparator zolpidem ER and placebo) Achieved primary endpoint Achieved primary and key secondary objectives against placebo and zolpidem ER on sleep onset and sleep maintenance variables, including the time spent awake in the second half of the night Phase I study (Study 106): Evaluate next day effects by measuring impairment of driving performance (Driving study) No carry-over effect in the following morning observed in the assessment of primary endpoint Phase I study (Study 108) *3 : Post-dose safety evaluation in the middle of night awakening in healthy volunteers 55 and older Met its primary endpoint demonstrating that postural stability was clinically meaningfully worse for zolpidem ER as compared with both treatment arms of lemborexant A novel sleep disorder treatment suitable for elderly patients; efficacy in sleep onset and sleep maintenance without clinically meaningful next morning effects 17 *1: Investigational. Co-development with Purdue Pharma. *2: Most common AEs in the lemborexant arms were headache and somnolence *3: The only AE observed in the lemborexant arms was headache

19 Projects targeting progress of aggressive factors accumulation in dementia-related field Lemborexant *1 Dual orexin receptor antagonist Neurology Pipeline Projects targeting transformation of symptoms over time in dementia-related field Non-dementia projects Sleep disorders Plan to submit in FY2018 Study 304: Controlled study in 1,006 patients age 55 years or older with active comparator zolpidem ER and placebo Obtained favorable topline results in March 2018 Study 303: Twelve-month, efficacy and safety study (six-month placebo-controlled study) Topline results anticipated in FY2018 ISWRD *2 due to AD/dementia Phase II study ongoing Topline results anticipated in early FY2018 Aducanumab *3 Anti-A-beta antibody Elenbecestat *3,4 BACE Inhibitor Early AD Phase III studies ongoing Last patient in (LPI) anticipated in mid 2018 Early AD Phase III studies ongoing Topline results anticipated in FY BAN2401 *3,5 Anti-A-beta protofibrils antibody E6011 Anti-fractalkine antibody E2027 PDE9 inhibitor E2730 Synaptic functional modulator E2082 Next generation AMPA receptor antagonist E2814 In-house discovered anti-tau antibody Early AD Phase II study ongoing Comprehensive evaluation from the final analysis at 18 months anticipated in Q Rheumatoid arthritis Phase II study ongoing Study 201 (in patients who have had an inadequate response to methotrexate) Topline results anticipated in Q1 FY2018 Study 202 (in patients who have had an inadequate response to biologics) Topline results anticipated in Q2 FY2018 Dementia with Lewy bodies Phase II study under preparation Epilepsy and other neurological disorders Phase I study ongoing Epilepsy and other neurological disorders Phase I study ongoing AD/dementia Initiation of Phase I study anticipated in FY2018 All projects are investigational. *1: Co-development with Purdue Pharma *2: Irregular sleep-wake rhythm disorder *3: Co-development with Biogen *4: Generic name for E2609.The generic name is not yet fixed at this time. *5: Licensed in from BioArctic

20 New Business Model Eisai AD Ecosystem by Platform Model 19

21 Architecture of the Eisai AD Ecosystem Comprised of Members, Partners and Platform Members Partners (Contents layers) Platform 20

22 Eisai s Dementia Platform Disease awareness Provide information on dementia through e-65.net* 1 Enhance awareness through TV ads Operate forums for citizens in collaboration with local government Collaboration with dementia support organizations Educational materials on dementia for elementary and secondary school students Treatment/Care options Provide information on social resources for dementia through e-65.net Aricept s various formulations to fulfill patients needs Indication of Aricept for dementia with Lewy bodies Medicine adherence support device e-okusuri-san Early diagnosis Eisai original diagnostic scale/treatment effect measure such as ADCOMS* 2 VSRAD* 3, diagnosis support software for early AD Collaboration with key opinion leaders in the field of dementia through academic meetings, education for physicians how to diagnose dementia and other activities Dementia-related clinical data Accumulate the data through development of disease modifiers Clinical data and post marketing clinical data of Aricept Real world data through Living Labs. Community networking Long-term activities to support patients with dementia and community networking with 527 communities in Japan Collaboration with local government (Agreement with 130 communities as of end of February 2018) Wellness Open. Living Labs. (2 sites as of end of February 2018) Interprofessional collaboration service Hikari One Team SP Tracking tool to support people with dementia and Seniors going out Me- MAMORIO Provide information and consultation Provide information on social resource map with medical institutions and regional support facilities on dementia through e- 65.net Respond to customers inquiries on dementia through hhc Hotline (since Aricept launched in 1999, approx. 140,000 inquiries have been received as of end of February 2018) Dementia diagnosis lump-sum insurance Dementia Support 21 Eisai s defining quality *1: e-65.net: Website for disease awareness and provision of information for patients with dementia and their families run by Eisai (only available in Japanese) *2: Alzheimer s Disease Composite Score (Pursue potential for diagnosis/scale to measure disease progression in the future) *3: Voxel-Based Specific Regional Analysis System for Alzheimer's Disease

23 Characteristics of Eisai s AD Ecosystem Eisai s dementia platform with robust connection with patients and their families Utilize local residents to gain knowledge of how to fulfill their true needs Socialization Recognize issues through socialization Internalization Examine the impact of solution Externalization Externalize ideas to solve problem based on socialization Combination Compile ideas as a solution to solve issues Platform centering on Eisai s superiority of clinical data More than 30 years of accumulated know-how and deep insight through Medicine Creation activities in dementia field Accumulated data in various disease stages (early to severe) through 40 double blind studies on dementia Human Capital with abundant experience in clinical studies Network with KOLs and medical facilities for clinical studies Knowledge of community networking with local communities gained through partnership agreements for dementia Sharing issues and needs for initiatives toward dementia Partnership agreement for dementia Develop plans to solve issues through council Validation through local communities Aim to enhance initiatives for community networking Implement activities for community networking at local governments with partnership agreement (130 communities *1 and approx. 25 million people *2 ) and Living Labs. (2 sites *1 and approx. 1.5 million people *2 ) 22 *1: As of end of February 2018 *2: Figures are approximate based on disclosed information on the websites of local governments

24 Category Design for AD Ecosystem Category: implement new technologies and ideas based on feedback from patients and their families Case of category design: design new categories through segmentation of patients hope not to get dementia Hope not to get dementia Hope to stay healthy Want to know how to prevent Hope for preventive medicine Anxiety regarding burden on caregivers or families Hope to live longer with family Hope for early diagnosis and early treatment Want to avoid causing any financial troubles Preventive medicine or disease modifiers for dementia Diet, lifestyle and exercise verified by science System for patients suspected to have dementia to enroll in appropriate clinical studies Websites to answer concerns about care System to search nursing care facilities which patients could spend time with their families Simple blood test to detect dementia Medical insurance to cover cost of treatment and care 23

25 Perspective for Plan EWAY 2025 Transformation to Platform Business Model from Value Chain Business Model 24 Enabling further proactive investment in R&D aiming to realize treatment for cure in Cancer Evolution and Preemptive Medicine in treatment for Alzheimer s disease Potential achievement of 100B yen level operating profit on average and 10% level ROE The achievability of EWAY (mid-term business plan) target is enhanced The achievability of FY2025 ROE target of 15% level is enhanced through continuous growth in revenue and operating profit beyond FY2021