FY 2017 (Ended March 31, 2018) Full Year Financial Results. Reference Data. May 15, Eisai Co., Ltd.
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1 Securities Code: 4523 FY 2017 (Ended 2018) Full Year Financial Results Reference Data May 15, 2018 Eisai Co., Ltd. For Inquiries: Public Relations: TEL +81-(0) Investor Relations: TEL +81-(0) Forward-Looking Statements and Risk Factors Materials and information provided in this financial disclosure may contain forward-looking statements based on current expectations, forecasts, estimates, business goals 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 that may cause significant fluctuations in the consolidated financial results of the Eisai Group or have a material effect on investment decisions are described below. These are risk factors that have been identified and assessed as of the disclosure date of the Financial Report. Risk factors associated with our business include, but are not limited to, risks related to product safety and quality, possible occurrence of side effects, lawsuits, changes in laws and regulations, intellectual property, uncertainties in new drug development, impact of medical cost containment measures, generic products, challenges arising in overseas operations, alliances with other companies, acquisitions of companies and product lines, outsourcing, IT security and information management, internal control systems for financial reporting, financial market conditions and currency movement, plant closure or shutdown, environmental issues, and disasters. 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.
2 Contents 1. Consolidated Statement of Income Segment Information Financial Results by Reporting Segment Revenue from Major Products Revenue Forecasts by Reporting Segment Consolidated Statement of Comprehensive Income Consolidated Statement of Cash Flows Capital Expenditures, Depreciation and Amortization Consolidated Statement of Financial Position Changes in Quarterly Results Trends in Financial Results Stock Information Number of Employees Major R&D Pipeline * Currency Exchange Rates US EU UK China (USD/JPY) (EUR/JPY) (GBP/JPY) (RMB/JPY) FY 2015 FY 2016 FY 2017 Yearly Average Rate Yearly Average Rate Yearly Average Rate Year End Rate Year End Rate Year End Rate FY 2018 Forecast Rate Eisai Co., Ltd. ( the Company") discloses its consolidated financial statements according to the International Financial Reporting Standards (IFRS). * The Eisai Group's ("the Group") business is comprised of pharmaceutical business and other business. The pharmaceutical business is organized into the following five reporting segments in this report: Japan (primarily Prescription Medicines, Generics, and OTC), Americas (North America), China, EMEA (Europe, the Middle East, Africa, and Oceania), and Asia and Latin America (primarily South Korea, Taiwan, Hong Kong, India, ASEAN, Central and South America). From January 1, 2018, the Group separated Latin American countries including Mexico and Brazil from the Americas pharmaceutical business and integrated them with the Asia pharmaceutical business to newly establish the Asia and Latin America pharmaceutical business. This change has been reflected in the segment information for this fiscal year prior to the change as well as for the previous fiscal year. This change has no significant impact. * All amounts are rounded to the nearest specified unit.
3 1. Consolidated Statement of Income FY 2016 FY 2017 FY 2018 Full year Ratio (%) Full year Ratio (%) YOY (%) Diff. Full year (forecasts) Ratio (%) Revenue Cost of sales Gross profit Selling, general and administrative expenses Selling expenses Personnel expenses Administrative and other expenses Research and development expenses Other income (10.6) Other expenses (4.4) - - Operating profit Financial income Financial costs (0.3) - - Profit before income taxes Income taxes Profit for the year Attributable to Owners of the parent Non-controlling interests (0.3) - - Comprehensive income for the year Earnings per share (EPS, yen) Dividends per share (DPS, yen) Return on equity (ROE, %) Dividend on equity ratio (DOE, %) Overseas revenue ratio (%) Notes Revenue 45.2 * Full year estimation for other income has had other expenses deducted from it. * From this fiscal year, the Group has clarified the definition of research and development expenses in order to more accurately reflect the condition of the business, and this has resulted in a portion of expenses relating to medical affairs activities, such as creation and provision of scientific evidence for health care providers, being apportioned to research and development expenses. Accordingly, an amount which was included in selling, general and administrative expenses during the previous fiscal year has been reclassified as research and development expenses Increase due to growth of Halaven, Lenvima, Humira and Fycompa Receipt of lump-sum payments due to strategic collaboration with Merck & Co., Inc. Kenilworth, NJ, USA (U.S. Merck) By segment, revenue from Japan pharmaceutical business increased, while China, EMEA, as well as Asia and Latin America pharmaceutical businesses each achieved double-digit growth Research and development expenses Other income Exchange rate effects Exchange rate sensitivity (annual effect of a 1 yen appreciation in currency value) Aggressive R&D investment in Alzheimer's disease projects, such as beta secretase cleaving enzyme (BACE) inhibitor E2609 (elenbecestat), and oncology projects One-off income (gain from a bargain purchase) of 9.3 billion yen recorded due to acquisition of a subsidiary in the same period of the previous fiscal year Revenue: billion yen, operating profit: billion yen Revenue (U.S. dollars: billion yen, Euro: -270 million yen, U.K. pounds: -40 million yen, Chinese renminbi: billion yen) Operating profit (U.S. dollars: +50 million yen, Euro: -180 million yen, U.K. pounds: +90 million yen, Chinese renminbi: billion yen) Reference Data [Consolidated] 1
4 2. Segment Information 1) Revenue by Reporting Segment FY 2016 CER YOY (%) Pharmaceutical Business Total Japan Pharmaceutical Business Americas Pharmaceutical Business United States China Pharmaceutical Business EMEA Pharmaceutical Business Asia and Latin America Pharmaceutical Business Other Business Consolidated revenue * Indicates revenue from external customers * CER=Constant Exchange Rates 2) Profit by Reporting Segment Full year FY 2016 FY 2017 Full year YOY (%) FY 2017 Full year Full year YOY (%) CER YOY (%) Pharmaceutical Business Total Japan Pharmaceutical Business Americas Pharmaceutical Business China Pharmaceutical Business EMEA Pharmaceutical Business Asia and Latin America Pharmaceutical Business Other Business R&D Expenses (117.2) (139.6) Group headquarters' management costs and other expenses (12.6) (12.6) Gain from a bargain purchase Gain on sale of subsidiaries Consolidated operating profit * CER=Constant Exchange Rates * From this fiscal year, the Group has clarified the definition of research and development expenses in order to more accurately reflect the condition of the business, and this has resulted in a portion of expenses relating to medical affairs activities, such as creation and provision of scientific evidence for health care providers, being apportioned to research and development expenses. Accordingly, an amount which was included in selling, general and administrative expenses during the previous fiscal year has been reclassified as research and development expenses. Reference Data [Consolidated] 2
5 3. Financial Results by Reporting Segment 1) Japan Pharmaceutical Business FY 2016 FY 2017 Full year Full year YOY (%) Revenue Prescription Medicines Generics Consumer Healthcare Business (OTC) Segment profit Japan prescription medicines - revenue from major products Fully human anti-tnf-α monoclonal antibody Humira Pain treatment (neuropathic pain, fibromyalgia) Lyrica Alzheimer's disease / Dementia with Lewy bodies treatment Aricept Proton-pump inhibitor Pariet** Peripheral neuropathy treatment Methycobal Insomnia treatment Lunesta Anticancer agent Halaven Anticancer agent Treakisym Elemental diet Elental** anticoagulant Warfarin Branched-chain amino acid preparation Livact** Anticancer agent Lenvima Antiepileptic agent Fycompa Consumer Healthcare Business Japan - revenue from major products Vitamin B2 preparation, "Chocola BB Plus," etc Chocola BB Group * The revenue for Pariet includes the revenue for triple formulation packs for Helicobacter pylori eradication, Rabecure Pack 400/800 and Rabefine Pack. * Co-promotion income has been booked as revenue for Lyrica. ** EA Pharma product Reference Data [Consolidated] 3
6 2) Americas Pharmaceutical Business (North America) FY 2016 FY 2017 Full year Full year YOY (%) Revenue <95.6> United States <95.4> Segment profit <113.8> Americas - revenue from major products Antiemetic agent Aloxi United States [Millions USD] [444] [357] <80.5> Anticancer agent Lenvima United States [Millions USD] [138] [196] <141.7> Antiepileptic agent Banzel United States [Millions USD] [126] [148] <116.9> Anticancer agent Halaven United States [Millions USD] [146] [139] <95.3> Antiepileptic agent Fycompa United States [Millions USD] [46] [60] <128.6> Proton pump inhibitor AcipHex [Millions USD] [66] [54] <81.7> Antiobesity agent BELVIQ [Millions USD] [34] [32] <93.7> * Year-on-year percentage: figures shown in angle brackets < > exclude the effects of foreign currency fluctuations. * The U.S. is the only country in the Americas where the Eisai Group directly markets AcipHex and BELVIQ. Reference Data [Consolidated] 4
7 3) China Pharmaceutical Business FY 2016 FY 2017 Full year Full year YOY (%) Revenue <109.8> Segment profit <105.1> China - revenue from major products Peripheral neuropathy treatment Methycobal [Millions RMB] [1,116] [1,121] <100.4> Liver disease / Allergic disease agents Stronger Neo-Minophagen C and Glycyron Tablets [Millions RMB] [523] [608] <116.3> Alzheimer's disease treatment Aricept [Millions RMB] [383] [449] <117.2> Proton pump inhibitor Pariet [Millions RMB] [244] [267] <109.7> * Year-on-year percentage: figures shown in angle brackets < > exclude the effects of foreign currency fluctuations. 4) EMEA Pharmaceutical Business (Europe, the Middle East, Africa and Oceania) FY 2016 FY 2017 Full year Full year YOY(%) Revenue <108.6> Segment profit <92.4> EMEA - revenue from major products Anticancer agent Halaven <102.4> Anticancer agent Lenvima / Kisplyx <161.9> Antiepileptic agent Fycompa <117.4> Antiepileptic agent Zebinix <125.4> Antiepileptic agent Zonegran <78.7> Antiepileptic agent Inovelon <109.7> * Year-on-year percentage: figures shown in angle brackets < > exclude the effects of foreign currency fluctuations. Reference Data [Consolidated] 5
8 5) Asia and Latin America Pharmaceutical Business FY 2016 FY 2017 Full year Full year YOY (%) Revenue <113.7> Segment profit <134.7> Asia and Latin America - revenue from major products Fully human anti-tnf-α monoclonal antibody Humira <112.6> Alzheimer's disease / Dementia with Lewy bodies treatment Aricept <107.9> Proton pump inhibitor Pariet <100.6> Peripheral neuropathy treatment Methycobal <101.4> Anticancer agent Halaven <103.8> Anticancer agent Lenvima <449.3> Antiepileptic agent Fycompa <165.9> * Year-on-year percentage: figures shown in angle brackets < > exclude the effects of foreign currency fluctuations. * Indication of Aricept for the treatment of dementia with Lewy bodies is approved in Japan, the Philippines and Thailand. Reference Data [Consolidated] 6
9 4. Revenue from Major Products 1) Neurology Products FY 2016 FY 2017 Full year Full year YOY(%) Neurology Products Total <103.0> Aricept (Alzheimer's disease / dementia with Lewy bodies treatment) <88.0> Japan China <117.2> Asia and Latin America <107.9> Methycobal (Peripheral neuropathy treatment) <98.0> Japan China <100.4> Asia and Latin America <101.4> Lyrica (Pain treatment [neuropathic pain, fibromyalgia]) - Japan Inovelon/Banzel (Antiepileptic agent) <115.8> Americas <116.9> EMEA <109.7> Fycompa (Antiepileptic agent) <136.1> Japan Americas <128.4> EMEA <117.4> Asia and Latin America <165.9> Lunesta (Insomnia treatment) - Japan Zonegran (Antiepileptic agent) <81.4> EMEA <78.7> Zebinix (Antiepileptic agent) - EMEA <125.4> BELVIQ (Antiobesity agent) <120.0> United States <93.7> Other * Year-on-year percentage: figures shown in angle brackets < > exclude the effects of foreign currency fluctuations. * Indication of Aricept for the treatment of dementia with Lewy bodies is approved in Japan, the Philippines and Thailand. * Co-promotion income has been booked as revenue for Lyrica. Reference Data [Consolidated] 7
10 2) Oncology Products FY 2016 FY 2017 Full year Full year YOY(%) Oncology Products Total <103.7> Halaven (Anticancer agent) <103.1> Japan Americas <95.5> EMEA <102.4> Asia and Latin America <103.8> Aloxi (Antiemetic agent) - Americas <80.5> Lenvima / Kisplyx (Anticancer agent) <145.6> Japan Americas <141.9> EMEA <161.9> Asia and Latin America <449.3> Treakisym/Symbenda (Anticancer agent) <159.9> Other <102.9> * Year-on-year percentage: figures shown in angle brackets < > exclude the effects of foreign currency fluctuations. Reference Data [Consolidated] 8
11 5. Revenue Forecasts by Reporting Segment (FY 2018) FY 2017 Full year Full year (forecasts) FY 2018 YOY (%) Japan Prescription Medicines Fully human anti-tnf-α monoclonal antibody Humira Alzheimer's disease / Dementia with Lewy bodies treatment Aricept Peripheral neuropathy treatment Methycobal Proton pump inhibitor Pariet** Insomnia treatment Lunesta Anticancer agent Halaven Anticancer agent Treakisym Anticancer agent Lenvima Elemental diet Elental** anticoagulant Warfarin Generics Consumer Healthcare Business (OTC) Vitamin B2 preparation, "Chocola BB Plus," etc. Chocola BB Group Americas United States China EMEA Asia and Latin America Other Consolidated revenue Global revenue from major products Lenvima / Kisplyx Japan Americas China EMEA Asia and Latin America Halaven Fycompa Japan Americas EMEA Asia and Latin America Japan Americas EMEA Asia and Latin America BELVIQ Aricept Pariet/AcipHex Americas * The revenue for Pariet includes the revenue for triple formulation packs for Helicobacter pylori eradication, Rabecure Pack 400/800 and Rabefine Pack. ** EA Pharma product Reference Data [Consolidated] 9
12 6. Consolidated Statement of Comprehensive Income FY 2016 FY 2017 Full year Full year YOY (%) Profit for the period Other comprehensive income Items that will not be reclassified to profit or loss Financial assets measured at fair value through other comprehensive income (0.6) Remeasurements of defined benefit plans Subtotal Items that may be reclassified subsequently to profit or loss Exchange differences on translation of foreign operations (9.3) (11.8) (2.4) Cash flow hedges (0.3) Subtotal (8.8) (11.6) (2.8) Total other comprehensive income, net of tax (5.4) (0.6) Comprehensive income for the period Attributable to Owners of the parent Non-controlling interests (0.3) Diff. Reference Data [Consolidated] 10
13 7. Consolidated Statement of Cash Flows FY 2016 FY 2017 Full year Full year Diff. Operating activities Profit before income taxes Depreciation and amortization (0.3) Impairment losses (0.1) (Increase) decrease in working capital Interest and dividends received Interest paid (2.6) (2.7) (0.0) Income taxes paid (12.5) (15.3) (2.9) Income taxes refund (8.8) Other (7.7) (2.9) 4.9 Net cash from operating activities Investing activities Purchases of property, plant and equipment (7.8) (10.5) (2.7) Proceeds from sales of property, plant and equipment Purchases of intangible assets (12.2) (14.2) (2.1) Net cash inflow on acquisition of subsidiaries (19.3) Net cash inflow on sale of subsidiaries (6.5) Purchases of financial assets (12.8) (4.6) 8.1 Proceeds from sales and redemption of financial assets Subtotal <Capital expenditures (cash basis)> 5.8 (13.0) (18.8) Payments of time deposits exceeding 3 months (72.9) (36.4) 36.5 Proceeds from redemption of time deposits exceeding 3 months Other (0.6) (0.1) 0.5 Net cash from (used in) investing activities (28.6) Financing activities Net increase (decrease) in short-term borrowings Proceeds from long-term borrowings (10.0) Repayment of long-term borrowings - (50.0) (50.0) Dividends paid (42.9) (42.9) (0.0) Other (2.5) (0.3) 2.2 Net cash from (used in) financing activities (35.4) (81.9) (46.4) Effect of exchange rate change on cash and cash equivalents (4.4) (1.1) 3.3 Net increase (decrease) in cash and cash equivalents Cash and cash equivalents at beginning of year Cash and cash equivalents at end of year Free cash flow * "Free cash flow" = "Net cash from operating activities" - "Capital expenditures (cash basis) # " # Expenditures from purchases of financial assets and proceeds from sale and redemption of financial assets are included in the formula used to calculate capital expenditures. Notes Cash flow from operating activities: Decrease in working capital due to increase in deposit received accompanying receipt of reimbursement of research and development payment from U.S. Merck Cash flow from investing activities: Proceeds from redemption of time deposits exceeding three months accompanying repayment of long-term borrowings Cash flow from financing activities: Repayment of long-term borrowings Reference Data [Consolidated] 11
14 8. Capital Expenditures, Depreciation and Amortization FY 2016 FY 2017 FY 2018 Full year Full year Diff. Full year (forecasts) Capital expenditures (cash basis) Property, plant and equipment Intangible assets Depreciation and amortization (0.3) 26.0 Property, plant and equipment Intangible assets (0.4) Consolidated Statement of Financial Position <Assets> FY 2016 FY Ratio (%) 2018 Ratio (%) % change Diff. Assets Non-current assets Property, plant and equipment (0.5) Goodwill (9.0) Intangible assets (5.1) Other financial assets (6.7) Other assets Deferred tax assets (13.1) Total non-current assets (33.5) Current assets Inventories (1.9) Trade and other receivables (3.0) Other financial assets (24.2) Other assets (2.8) Cash and cash equivalents Total current assets Total assets 1, , Notes Assets Increase in cash and cash equivalents due to primarily receipt of upfront payment and reimbursement for research and development payment from U.S. Merck Decrease in other financial assets under current assets due to proceeds from redemption of time deposits exceeding three months Reference Data [Consolidated] 12
15 <Equity and Liabilities> Equity Equity attributable to owners of the parent March 31, 2017 Ratio (%) March 31, 2018 Ratio (%) % change Diff. Share capital Capital surplus (0.1) Treasury shares (35.9) (3.5) (35.3) (3.4) Retained earnings Other components of equity (11.6) Total equity attributable to owners of the parent Non-controlling interests Total equity Liabilities Non-current liabilities FY 2016 FY 2017 Borrowings (6.7) Other financial liabilities Retirement benefit liabilities (2.7) Provisions Other liabilities (2.5) Deferred tax liabilities Total non-current liabilities (11.2) Current liabilities Bonds and borrowings (33.6) Trade and other payables (2.7) Other financial liabilities Income tax payables Provisions Other liabilities Total current liabilities Total liabilities Total equity and liabilities 1, , Notes Equity Increase in retained earnings due to increase in profit Decrease in other components of equity due to a decrease in exchange differences Liabilities Increase in other financial liabilities under current liabilities due to recording of reimbursement of research and development payment from U.S. Merck as deposits received Decrease in bonds and borrowings under current liabilities due to repayment of long-term borrowings Reference Data [Consolidated] 13
16 10. Changes in Quarterly Results 1) Income Statement FY 2016 FY 2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Revenue Cost of sales Gross profit Selling, general and administrative expenses Selling expenses Personnel expenses Administrative and other expenses Research and development expenses Other income Other expenses Operating profit Financial income Financial costs Profit before income taxes Income taxes (0.7) Profit for the period Attributable to Owners of the parent Non-controlling interests Comprehensive income for the period (23.0) (8.9) Earnings per share (EPS, yen) * From this fiscal year, the Group has clarified the definition of research and development expenses in order to more accurately reflect the condition of the business, and this has resulted in a portion of expenses relating to medical affairs activities, such as creation and provision of scientific evidence for health care providers, being apportioned to research and development expenses. Accordingly, an amount which was included in selling, general and administrative expenses during the previous fiscal year has been reclassified as research and development expenses. 2) Cash Flows FY 2016 FY 2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Net cash from (used in) operating activities (4.8) (3.7) Net cash from (used in) investing activities 23.4 (10.3) (24.5) (17.1) (10.4) 0.9 (0.6) 27.2 Net cash from (used in) financing activities (14.7) (0.1) (20.7) 0.1 (11.7) (5.0) (12.3) (52.9) Cash and cash equivalents at the end of period Free cash flow (13.7) * "Free cash flow" = "Net cash from operating activities" - "Capital expenditures (cash basis) # " # Expenditures from purchases of financial assets and proceeds from sale and redemption of financial assets are included in the formula used to calculate capital expenditures. Reference Data [Consolidated] 14
17 3) Capital Expenditures, Depreciation and Amortization FY 2016 FY 2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Capital expenditures (cash basis) Property, plant and equipment Intangible assets Depreciation and amortization Property, plant and equipment Intangible assets ) Financial Positions Jun Sep Dec Mar Jun Sept. 30, 2017 Dec Mar Total assets , , , , , ,049.0 Equity Attributable to owners of the parent Liabilities Borrowings Ratio of equity attributable to owners of the parent (%) Liabilities ratio (Net DER / times) * "Liabilities ratio (Net DER)"=("Interest-bearing debt" ("Bonds and borrowings") - "Cash and cash equivalents" - "Time deposits exceeding three months, etc." - "Parent company holding investment securities # ") / "Equity attributable to owners of the parent" # Parent company holding investment securities are included in the formula used to calculate liabilities ratio. Reference Data [Consolidated] 15
18 5) Changes in Quarterly Revenue from Major Products (1) Neurology Products FY 2016 FY 2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Neurology Total Aricept (Alzheimer's disease / dementia with Lewy bodies treatment) Japan China Asia and Latin America Methycobal (Peripheral neuropathy treatment) Japan China Asia and Latin America Lyrica (Pain treatment [neuropathic pain, fibromyalgia]) - Japan Inovelon/Banzel (Antiepileptic agent) Americas EMEA Fycompa (Antiepileptic agent) Japan Americas EMEA Asia and Latin America Lunesta (Insomnia treatment) - Japan Zonegran (Antiepileptic agent) EMEA Zebinix (Antiepileptic agent) - EMEA BELVIQ (Antiobesity agent) United States Other * Co-promotion income has been booked as revenue for Lyrica. * Indication of Aricept for the treatment of dementia with Lewy bodies is approved in Japan, the Philippines and Thailand. (2) Oncology Products FY 2016 FY 2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Oncology Total Halaven (Anticancer agent) Japan Americas EMEA Asia and Latin America Aloxi (Antiemetic agent) - Americas Lenvima / Kisplyx (Anticancer agent) Japan Americas EMEA Asia and Latin America Treakisym / Symbenda (Anticancer agent) Other Reference Data [Consolidated] 16
19 11. Trends in Financial Results (IFRS) <Income statement data> FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 Full year Full year Full year Full year Full year Full year Revenue Cost of sales Selling, general and administrative expenses Research and development expenses Other income Other expenses Operating profit Profit for the year Comprehensive profit for the year Cash flows Net cash from (used in) operating activities Net cash from (used in) investing activities (18.8) (6.7) (28.6) 17.0 Net cash from (used in) financing activities (82.1) (115.1) (59.7) (72.9) (35.4) (81.9) Free cash flow Financial positions Total assets 1, , , ,049.0 Equity Share capital Attributable to owners of the parent <Capital expenditures, Depreciation and Amortization> Capital expenditures (cash basis) Depreciation and amortization <Managerial indices> Dividend payment Dividends on equity (DOE, %) Dividend payout ratio (DPR, %) Return on sales ratio (%) Return on equity (ROE, %) Return on assets (ROA, %) Total capital turnover ratio (number of times) Shareholders equity ratio (%) Liabilities ratio (Net DER / times) (0.06) (0.11) (0.27) Leverage (times) Earnings per share (EPS, yen) Diluted EPS (yen) Cash dividends per share (yen) Price-book value ratio (PBR, times) Number of consolidated subsidiaries * Due to the voluntary adoption of IFRS from FY 2013, only the past six periods are available for comparison * "Free cash flow" = "Net cash provided by (used in) operating activities" - "Capital expenditures (cash basis) # " # Expenditures from purchases of financial assets and proceeds from sale and redemption of financial assets are included in the formula used to calculate capital expenditures. * "Liabilities ratio (Net DER)"=("Interest-bearing debt" ("Bonds and borrowings") -"Cash and cash equivalents" - "Time deposits exceeding three months, etc." - "Parent company holding investment securities # ") / "Equity attributable to owners of the parent" # Parent company holding investment securities are included in the formula used to calculate liabilities ratio. * "Leverage" = "Total assets" / "Equity attributable to owners of the parent" Reference Data [Consolidated] 17
20 <Values for Reference Trends in Financial Results (J-GAAP)> <Income statement data> FY2008 FY2009 FY2010 FY2011 FY2012 FY2013 Full year Full year Full year Full year Full year Full year Net sales Cost of sales R&D expenses SG&A expenses Operating income Ordinary income Net income (loss) Cash income <Cash flow statement data> Net cash provided by (used in) operating activities Net cash provided by (used in) investing activities Net cash provided by (used in) financing activities (55.0) (69.8) (58.8) (2.6) (31.0) (49.2) (68.0) (78.0) (81.8) (114.8) Free cash flow <Balance sheet data> Common stock Total assets 1, , , , Shareholders' equity <Capital expenditures and Depreciation/Amortization> Capital expenditures (accrual basis) Depreciation and amortization <Managerial indices> Dividend payment Dividends on equity (DOE, %) Dividend payout ratio (DPR, %) Return on sales ratio (%) Return on equity (ROE, %) Return on assets (ROA, %) Total capital turnover ratio (no. of times) Shareholders equity ratio (%) Liabilities ratio (Net DER / times) Leverage (times) Earnings per share (EPS, yen) Diluted EPS (yen) Cash EPS (yen) Cash dividends per share (yen) Price-book value ratio (PBR, times) Treasury stock purchase (thousand shares) Treasury stock purchase Number of consolidated subsidiaries * "Cost of sales" includes "Provision for (reversal of) sales returns-net." * "Free cash flow" = "Net cash provided by (used in) operating activities" - "Capital expenditures (cash basis)" * "Diluted EPS" for FY2009 onwards has been calculated in accordance with new accounting standards. * "Depreciation and amortization" includes amortization of "Intangible assets." The definition was partially changed in FY2008. * "Cash income" = "Net income (loss)" + "Depreciation of PP&E and amortization of intangible assets" + "In-process R&D expenses" + "Amortization of goodwill" + "Loss on impairment of long-lived assets (including loss on devaluation of investment securities)" * In accordance with the partial change in definition of "Cash income" and "Cash EPS", results for the previous year have been amended. * "Cash EPS (Cash income per share)" = "Cash income" / "Average number of outstanding shares for the period (after deduction of treasury stock)" * "Liabilities ratio (Net DER)" = ("Interest-bearing debt" ("Borrowings" + "Bonds and debentures") - "Cash and cash in banks" - "Short-term investments") / "Shareholders' equity" * "Leverage" = "Total assets" / "Shareholders equity" Reference Data [Consolidated] 18
21 12. Stock Information 1) Number of Shares Issued and Shareholders As of 2018 Total Number of Authorized Shares 1,100,000,000 * Number of shares issued and outstanding includes treasury stock. 2) Principal Shareholders As of 2018 JP Morgan Chase Bank Nippon Life Insurance Company Saitama Resona Bank Limited * Number of shares has been rounded down to the nearest thousand. * The percentage of shares held is calculated in proportion to the number of shares issued and outstanding including treasury stock. * Treasury stock (10,228 thousand shares, 3.45%) has been excluded as it has no voting rights. * While the substantial shareholding reports (amendment reports) received up until 2018 are listed below, in cases where substantial shareholdings cannot be confirmed by the shareholder registry as of 2018 or where the number of shares held does not account among the top 10 shareholders, such shareholders are not listed in the above table. Furthermore, the percentage of shares held given inside the brackets is calculated in proportion to the number of shares issued and outstanding including treasury stock. (1) As of July 13, 2015, four companies including Mitsubishi UFJ Financial Group jointly hold 16,113 thousand shares (5.43%). (Amendment report dated July 21, 2015) 3) Number of Shareholders by Category Financial institutions Securities companies Other Japanese corporations Corporations outside Japan, etc. Individuals and others Treasury stock Total , , , , , ,387 4) Number of Shares Held by Category (1,000 shares) Financial institutions Securities companies Other Japanese corporations Corporations outside Japan, etc. Individuals and others Treasury stock Total * Number of shares has been rounded down to the nearest thousand. Number of Shares Number of Shares Number of Average Number of Issued and Outstanding Held as Treasury Stock Shareholders Shares per Shareholder 296,566,949 10,228,499 60,948 4,866 Trust & Custody Services Bank, Ltd. as trustee for Mizuho Bank, Ltd. Retirement Benefit Trust Account re-entrusted by Mizuho Trust and Banking Co., Ltd. (2) As of July 31, 2015, two companies including the Wellington Management Company, LLP jointly hold 27,087 thousand shares (9.13%). (Amendment report dated August 7, 2015) (3) As of April 15, 2016, three companies including Sumitomo Mitsui Trust Bank, Ltd. jointly hold 14,926 thousand shares (5.03%). (Substantial shareholding report dated April 21, 2016) (4) As of October 14, 2016, two companies including Mizuho Bank, Ltd. jointly hold 18,900 thousand shares (6.37%). (Substantial shareholding report dated October 21, 2016) (5) As of November 24, 2016, Vanguard Health Care Fund holds 14,838 thousand shares (5.00%). (Substantial shareholding report dated December 15, 2016) (6) As of August 15, 2017, eleven companies including Black Rock Japan Co., Ltd. jointly hold 18,308 thousand shares (6.17%). (Amendment report dated August 21, 2017) (7) As of March 15, 2018, Nomura Asset Management Co., Ltd. holds 14,963 thousand shares (5.05%). (Substantial shareholding report dated March 22, 2018) Ratio (%) Ratio (%) Shares (1,000 shares) Percentage of shares held (%) Japan Trustee Services Bank, Ltd. (Trust Account) 32, The Master Trust Bank of Japan, Ltd. (Trust Account) 28, , , , , State Street Bank West Client - Treaty , Japan Trustee Services Bank, Ltd. (Trust Account 5) 4, The Naito Foundation 4, Japan Trustee Services Bank, Ltd. (Trust Account 7) 3, Ratio (%) Ratio (%) (investors) Diff. Diff. 130, , ,926 8, , , , , , , , ,316 10, , , , Reference Data [Consolidated] 19
22 5) Breakdown of Shareholders by Number of Shares Held (investors) million or more shares ,000 ~ 999,999 shares ,000 ~ 99,999 shares ,000 ~ 9,999 shares 10, , ~ 999 shares 46, , Less than 100 shares 3, , Total 62, , ,387 Ratio (%) 2018 Ratio (%) Diff. 6) Breakdown by Shareholder Holding Size / Number of Shares Held (1,000 shares) 1 million or more shares 198, , , ,000 ~ 999,999 shares 44, , ,000 ~ 99,999 shares 20, , ,387 1,000 ~ 9,999 shares 22, , ~ 999 shares 10, , Less than 100 shares Total 296, , * Number of shares has been rounded down to the nearest thousand. 13. Number of Employees ) Number of Employees on Consolidated Basis (employees) Total employees 10,183 9,877 10,452 10,456 Japan 4,712 4,523 5,009 4,914 Americas (North America) 1,719 1,290 1,296 1,240 China 1,607 1,875 1,909 1,906 EMEA (Europe, the Middle East, Africa and Oceania) ,022 Asia and Latin America 1,252 1,276 1,255 1,374 2) Number of Employees on Non-Consolidated Basis (employees) Total employees (Eisai Co., Ltd.) 3,514 3,504 3,246 3,172 Production Research and development Sales, marketing and administration 2,166 2,174 1,909 1,874 * The number of total employees shown above includes staff dispatched to Eisai Co., Ltd. from other group companies, and excludes the employees of Eisai Co., Ltd. dispatched to other group companies. Ratio (%) 2018 Ratio (%) Diff. Reference Data [Consolidated] 20
23 14. Major R&D Pipeline In-House R&D Pipeline List Product Name / Development Code Reference Data [R&D Pipeline] 21 Additional Indication, etc.** Development Stage*** Therapeutic Area**** New Approval Fycompa (Monotherapy for partial-onset seizures) AI (US) approved Neurology Pariet (Maintenance therapy for proton pump inhibitor-resistant reflux esophagitis) ADA (JP) approved GI Rectabul (Ulcerative colitis)* (JP) approved GI Aricept (Severe Alzheimer s disease) AI (CN) approved Neurology Goofice (Chronic constipation)* (JP) approved GI Lenvima (Hepatocellular carcinoma: HCC) AI (JP) approved Oncology Submitted / Preparing for Submission Lenvima (HCC) Al (US/EU/CN/AS) submitted Oncology Halaven (Breast cancer) (CN) submitted Oncology AJG555 (Chronic constipation)* (JP) submitted GI Fycompa (Pediatric epilepsy) AI (US) submitted Neurology Fycompa (Adjunctive therapy for partial-onset seizures) (CN) preparing for submission Neurology ME2125 (Parkinson s disease) (JP) preparing for submission Neurology Clinical Trial Stage E2006 (Insomnia disorder) (JP/US/EU) PIII Neurology E2609 (Early Alzheimer s disease) (JP/US/EU) PIII Neurology BIIB037 (Early Alzheimer s disease) (JP/US/EU) PIII Neurology Lenvima (Thyroid cancer) (CN) PIII Oncology AJM300 (Ulcerative colitis)* (JP) PIII GI Livact (Hypoalbuminemia) (CN) PIII GI Fycompa (Lennox-Gastaut syndrome) AI (JP/US/EU) PIII Neurology Fycompa (Pediatric epilepsy) AI (JP/US/EU) PIII Neurology Fycompa (Monotherapy for partial-onset seizures) AI (JP) PIII Neurology Lenvima (Renal cell carcinoma, first-line) AI (JP/US/EU) PIII Oncology BAN2401 (Alzheimer s disease) (JP/US/EU) PII Neurology E2006 (Irregular sleep-wake rhythm disorder and Alzheimer s disease dementia) (JP/US) PII Neurology E2027 (Dementia with Lewy bodies) (JP/US/EU) PII/III Neurology MORAb-003 (Platinum-sensitive ovarian cancer) (JP/US/EU) PII Oncology MORAb-004 (Melanoma) (US/EU) PII Oncology MORAb-009 (Mesothelioma) (US/EU) PII Oncology E7777 (Peripheral T-cell lymphoma, cutaneous T-cell lymphoma) (JP) PII Oncology E7438 (Non-Hodgkin B-cell lymphoma) (JP) PII Oncology Halaven (Combination therapy with anti-pd1 antibody pembrolizumab in breast cancer) (US) PI/II Oncology Lenvima (Combination therapy with anti-pd1 antibody pembrolizumab in select solid tumors) (US) PI/II (JP) PI Oncology E6007 (Ulcerative colitis)* (JP) PII GI E6011 (Rheumatoid arthritis) (JP) PII Other E6011 (Primary biliary cholangitis)* (JP) PII Other Halaven (Bladder cancer) AI (US/EU) PI/II Oncology Lenvima (Non-small cell lung cancer, RET translocations) AI (JP/US/EU/AS) PII Oncology Lenvima (Biliary tract cancer) AI (JP) PII Oncology Halaven (Combination therapy with PEGPH20 in breast cancer) (US) PI/II Oncology H3B-6545 (Breast cancer) (US) PI/II Oncology E6011 (Crohn s disease)* (JP) PI/II Other BELVIQ (Obesity) (JP) PI Neurology E2730 (Epilepsy) (US) PI Neurology E2082 (Epilepsy) (JP) PI Neurology E7090 (Solid tumors) (JP) PI Oncology MORAb-066 (Solid tumors) (US) PI Oncology H3B-6527 (HCC) (US/EU) PI Oncology H3B-8800 (Blood cancer) (US/EU) PI Oncology Lenvima (Combination therapy with anti-pd1 antibody pembrolizumab in HCC ) (JP/US) PI Oncology E7386 (Solid tumors) (EU) PI Oncology MORAb-202 (Solid tumors) (JP) PI Oncology Lenvima (Combination therapy with anti-pd1 antibody nivolumab in HCC) (JP) PI Oncology E7130 (Solid tumors) (JP) PI Oncology E6130 (Inflammatory bowel disease)* (JP) PI GI MORAb-022 (Rheumatoid arthritis) (US) PI Other E6742 (Autoimmune disease) (US) PI Other Halaven (Liposome formulation) AF (JP/EU) PI Oncology * EA Pharma pipeline product ** AI: Additional Indication, AF: Additional Formulation, ADA: Additional Dosage and Administration *** JP: Japan, US: United States, EU: Europe, CN: China, AS: Asia (excluding Japan and China), P: Clinical Phase ****GI: Gastrointestinal Disorders Development of Aricept for regression symptoms in patients with Down syndrome has been discontinued at the Phase II stage in Japan. E7046, which was being investigated in a Phase I clinical study conducted in Europe and the U.S., was removed from this list due to the conclusion of an agreement to license-out in these regions. Development of E6071 for autoimmune disorder has been discontinued at the Phase I stage in Europe and was therefore removed from this list. : Development progress from April 2017 onwards : Development progress from January 2018 onwards
24 (1) Neurology Development Code: E2020 Generic Name: donepezil Product Name: Aricept Indications / Drug class: Treatment for Alzheimer s disease / dementia with Lewy bodies In-house Description: Increases levels of the neurotransmitter acetylcholine in the brain by inhibiting the enzyme acetylcholinesterase from breaking down acetylcholine, thereby slowing the overall progression of symptoms associated with Alzheimer s disease (AD). Currently approved in more than 100 countries around the world for the treatment of mild to moderate AD. Also approved as a treatment for patients with severe AD in numerous countries including the United States, Japan, Canada, and several other Asian and Latin American countries. Approved in Japan, the Philippines and Thailand for dementia with Lewy bodies. Severe Alzheimer s disease (Additional Indication) Study 339 CN: approved (November 2017) Development for regression symptoms in patients with Down syndrome has been discontinued at the Phase II stage in Japan. Development Code: E2007 Generic Name: perampanel Product Name: Fycompa Indications / Drug class: Antiepileptic agent / AMPA receptor antagonist In-house Description: A selective antagonist against the AMPA receptor (a glutamate receptor subtype). Approved as an adjunctive therapy for partial-onset seizures in over 55 countries including Japan, the United States, in Europe and in Asia. Also approved as an adjunctive therapy for primary generalized tonic-clonic seizures in over 50 countries including Japan, the United States, in Europe and in Asia. In the United States, an oral suspension formulation has been approved and is being marketed. Monotherapy for partial-onset seizures (Additional Indication) Lennox-Gastaut syndrome (Additional Indication) Study 342 Pediatric epilepsy (Additional Indication) 311 Adjunctive therapy for partial-onset seizures 335 US: approved (July 2017) JP: PIII Submission Target: FY JP/US/EU: PIII US: submitted (March 2018) JP/ EU: PIII Submission Target: FY2018 CN: preparing for submission Submission Target: FY2018 Development Code: E2006 Generic Name: lemborexant Indications / Drug class: Orexin receptor antagonist In-house Description: By antagonizing the orexin receptors that are involved in the regulation of sleep and wakefulness, it is expected to alleviate wakefulness, thereby facilitating the initiation and maintenance of natural sleep. Submission Target: FY2018 Insomnia disorder Study 303/304 JP/US/EU: PIII Joint development with Purdue Pharma Irregular sleep-wake rhythm disorder and Joint development with 202 JP/US: PII Alzheimer s disease dementia Purdue Pharma Development Code: E2609 Generic Name: elenbecestat Indications / Drug class: Treatment for Alzheimer s disease / beta secretase cleaving enzyme In-house (BACE) inhibitor Description: By inhibiting beta-site amyloid precursor protein cleaving enzymes (BACE), the agent reduces the amount of amyloid beta in the brain, potentially slowing the progression of Alzheimer's disease. Study 301/302 Joint development with Early Alzheimer s disease JP/US/EU: PIII (MISSION AD1/2) Biogen Inc. Development Code: BIIB037 Generic Name: aducanumab Indications / Drug class: Treatment for Alzheimer s disease / anti-a monoclonal antibody In-license (Biogen Inc.) Description: Aducanumab is a human recombinant monoclonal antibody (mab) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune s technology platform called Reverse Translational Medicine (RTM). Biogen licensed aducanumab from Neurimmune. Aducanumab is thought to target aggregated forms of amyloid beta including soluble oligomers and insoluble fibrils which can form into amyloid plaque in Alzheimer s disease patients. ENGAGE/EMERGE Joint development with Early Alzheimer s disease JP/US/EU: PIII Inj. Study Biogen Inc. Development progress from April 2017 onwards Development progress from January 2018 onwards Reference Data [R&D Pipeline] 22
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