Eisai Co,. Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Execution of Comprehensive Strategic Collaboration for Eisai s In-house Discovered Anticancer Agent LENVIMA Eisai Conference for Media and Investors Eisai Co., Ltd. March 8, 2018
Safe Harbor Statement 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 that 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 examination periods and 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. The Company cannot guarantee the actual outcomes and results for any forward-looking statements. Furthermore, 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. The English-language presentation was translated from the original Japanese-language version. In the event of any inconsistency between the statements in the two versions, the statements in the Japanese-language version shall prevail. 1
Intent for Collaboration Aim to realize value creation for patients with cancer in Cancer Evolution Era through innovative business model 2
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 3
Changes in tumor diameter (%) Changes in tumor diameter (%) Combination Therapy Rationale Observations from Phase Ib/II study targeting seven tumors *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 4 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
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 5 * Investigational
6 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 proceeding 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.
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 7 * In addition to oncology dedicated sales reps, approx. 980 sales reps also co-operate oncology marketing
Financial Considerations One-time payment: 950 million U.S. dollars (approx. 101.0 billion yen*) Upfront payment: 300 million U.S. dollars (approx. 32.0 billion yen*) One-time option payments associated with Merck & Co., Inc., Kenilworth, N.J., U.S.A. exercising for certain option rights through FY2020: 650 million U.S. dollars (approx. 69.0 billion yen*) Reimbursement for R&D payment: 450 million U.S. dollars (approx. 48.0 billion yen*) To be recorded in accordance with occurrence of R&D expenses by accounting process assumed by Eisai Milestone payments: Maximum of up to 4.36 billion U.S. dollars in total (approx. 462.0 billion yen*) Clinical and regulatory milestones: Up to $385 million U.S. dollars (approx. 41.0 billion yen*) associated with the achievement of clinical and regulatory milestones including regulatory approval of indications in hepatocellular carcinoma or renal cell carcinoma Milestones associated with sales of LENVIMA: Maximum of up to 3.97 billion U.S. dollars (approx. 421.0 billion yen*) Maximum of up to 5.76 billion U.S. dollars in total (approx. 611.0 billion yen*) if all goals for all indications are achieved 8 * USD 1= 106 yen
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 5,000 500 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 2,000 200 9 0 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 *
Potential Impact on Plan EWAY 2025 Enabling further proactive investment in R&D aiming at realization of curative treatment in Cancer Evolution and Preemptive Medicine in treatment for Alzheimer s disease Accordingly, the achievability of FY2020 target is enhanced by enabling operating profit of 100B yen level on average and 10% level of ROE 10 The achievability of FY2025 ROE target of 15% level is enhanced through continuous growth in revenue and operating profit beyond FY2021