Kyowa Hakko Kirin Co., Ltd.

Transcription

1 October 30, 2018 Kyowa Hakko Kirin Co., Ltd. Appendix to the Consolidated Financial Summary (IFRS) Fiscal 2018 Third Quarter (January 1, September 30, 2018) These materials were made as a supplement to the Kessan Tanshin (Consolidated Financial Summary, IFRS), disclosed at the Tokyo Stock Exchange on October 30, 2018 for the first nine months of Fiscal 2018, from January 1, 2018 to September 30, This document is an English translation of parts of the Japanese-language original. The statements, including earnings forecasts, contained in these materials are based on the information currently available to the Company and on certain assumptions deemed to be reasonable by management. As such, they do not constitute guarantees by the Company of future performance. Actual results may differ materially from these projections for a wide variety of reasons. Figures presented in these materials have been rounded to the nearest tenth. Figures inside parenthesis presented in these materials indicate negative values.

2 Index Page Ⅰ. Consolidated Financial Results (IFRS) 1. Trends in consolidated profit 1 2. Revenue by geographic region 1 3. Other trends 2 Ⅱ. Consolidated Statement of Cash Flows (IFRS) 2 Ⅲ. Core Operating Profit or Loss by Segment (IFRS) 3 Ⅳ. Revenue from Main Products of Pharmaceuticals Segment (IFRS) 4 V. R&D Pipeline 6 The average exchange rates for each period were as follows: USD EUR GBP Unit: Yen FY 2017 FY 2018 FY 2018 results results forecasts Contact Kyowa Hakko Kirin Co., Ltd. Corporate Communications Department Tel

3 Ⅰ. Consolidated Financial Results (IFRS) 1. Trends in consolidated profit Change amount % Revenue Cost of sales Gross profit Selling, general and administrative expenses Research and development expenses Share of profit (loss) of investments accounted for using equity method Core operating profit Other income Other expenses Finance income (costs) Profit before tax Income tax expense Profit EPS ( /share) Annual dividend ( /share) Dividend payout ratio (%) (7.3) % (96.3) (129.1) (88.0) 8.3 (114.0) 88% % (81.4) (113.0) (85.9) (4.5) (117.0) 104% (35.8) (49.2) (34.4) 1.4 (49.5) 101% (3.1) (4.5) (0.5) 11% % (2.3) (8.4) (1.1) (0.1) (0.5) (0.7) % (14.3) (13.0) (15.4) (1.1) % ROE (%) * "" in these materials, excluding those of share of profit (loss) of investments accounted for using equity method, core operating profit, profit before tax, profit, EPS, and dividend payout ratio, which have been revised, still remain unchanged from the earnings forecasts released on February 8, Revenue by geographic region Percentage of consolidated revenue Percentage of consolidated revenue Percentage of consolidated revenue Japan % % % International % % % Americas % % % Europe % % % Asia % % % Others % % % Total consolidated revenue % % % * Revenue is classified by region or country based on location of customer

4 3. Other trends (1) Research and development expenses Research and development (R&D) expenses R&D expenses to revenue ratio % % % % Pharmaceuticals R&D expenses to revenue ratio % % % % Bio-Chemicals (2) Capital expenditures (property, plant and equipment) Capital expenditures Pharmaceuticals Bio-Chemicals (3) Depreciation and amortization (property, plant and equipment and intangible assets) Depreciation and amortization Amortization of intangible assets Pharmaceuticals Amortization of intangible assets Bio-Chemicals II. Consolidated Statement of Cash Flows (IFRS) Change amount Cash flows from operating activities Cash flows from investing activities Cash flows from financing activities Effect of exchange rate changes on cash and cash equivalents Net increase (decrease) in cash and cash equivalents Transfer to assets held for sale Cash and cash equivalents at beginning of period Cash and cash equivalents at end of period* * Cash reserves at end of period Cash and cash equivalents at end of period 49.1 (35.0) (13.9) (0.0) (45.3) (18.3) (1.1) (30.8) (16.5) (0.4) (1.3) (2.7) 4.2 (2.6) (1.5) (2.6) Loans receivable from parent in excess of three months Time deposits whose maturity periods exceed three months Cash reserves at end of period

5 Ⅲ. Core Operating Profit or Loss by Segment (IFRS) 1. Pharmaceuticals segment Change amount % Revenue (5.3) % Revenue from external customers (5.4) % Japan (12.8) % International % International revenue ratio 27% 28% 32% - 31% - Americas % Europe % Asia % Others (0.4) % Inter-segment revenue Cost of sales Gross profit Selling, general and administrative expenses Research and development expenses Share of profit (loss) of investments accounted for using equity method Core operating profit % (58.8) (79.1) (53.9) 4.9 (70.0) 89% (0.4) % (68.3) (95.5) (72.3) (4.0) (99.0) 104% (33.6) (46.1) (32.3) 1.3 (46.5) 101% (3.1) (4.5) (0.5) 11% % * Revenue is classified by region or country based on location of customer. * The figures represent amounts before elimination of inter-segment transactions. 2. Bio-Chemicals segment Change amount % Revenue (2.3) % Revenue from external customers (2.0) % Japan (1.0) % International (1.0) % International revenue ratio 46% 45% 46% - 46% - Americas (0.3) % Europe (0.0) % Asia (0.5) % Others (0.0) % Inter-segment revenue Cost of sales Gross profit Selling, general and administrative expenses Research and development expenses Core operating profit (0.3) % (40.0) (53.3) (36.5) 3.5 (47.0) 88% % (13.2) (17.6) (13.7) (0.5) (18.0) 102% (2.3) (3.1) (2.2) 0.0 (3.0) 98% % * Revenue is classified by region or country based on location of customer. * The figures represent amounts before elimination of inter-segment transactions

6 IV. Revenue from Main Products of Pharmaceuticals Segment (IFRS) <Accumulative> Japan International Indication / Product name Renal anemia treatment drug Nesp Regpara Orkedia Rocaltrol Type-2 diabetes Onglyza Cardiovascular (Hypertension & angina pectoris) Coniel Agent for decreasing the incidence of febrile neutropenia G-Lasta Transdermal persistent pain Fentos Poteligeo Rituximab BS [KHK] Chronic idiopathic thrombocytopenic purpura Romiplate Antiallergenic Allelock Antiallergic eyedrops Patanol Ulcerative colitis Asacol Psoriasis vulgaris Dovobet Psoriasis Lumicef Parkinson's disease Nouriast Antiepileptic Depakene Change amount % (1.8) % (3.2) % (0.2) % % (1.1) % % (0.4) % (0.0) % (0.1) % (2.4) % % (1.0) % % % % (0.9) % Technology out-licensing (0.6) % Renal anemia treatment drug Nesp % Regpara % Agent for decreasing the incidence of febrile neutropenia Neulasta/Peglasta % Neutropenia treatment drug Gran % X-linked hypophosphatemia (XLH) Crysvita Cancer pain Abstral % Cancer pain PecFent % Mitomycin-C (0.7) % Chemotherapy-induced nausea and vomiting drug Sancuso % Opioid-induced constipation (OIC) Moventig % Replacement therapy with testosterone for male hypogonadism Tostran/Fortesta % Osteoporosis drug Adcal-D % Technology out-licensing % * Revenue is classified as Japan or International (other than Japan) based on customer location. * Revenue listed as Technology out-licensing specifies revenue from the upfront payment, milestone revenue, and running royalties revenue that are obtained based on licensing agreements recognizing the granting to third parties the rights for development, manufacturing and sales of the Group's pipeline compounds or the use of technology, etc

7 IV. Revenue from Main Products of Pharmaceuticals Segment (IFRS) <Quarterly> Japan Indication / Product name Renal anemia treatment drug Nesp Regpara Orkedia Rocaltrol Type-2 diabetes Onglyza Cardiovascular (Hypertension & angina pectoris) Coniel Agent for decreasing the incidence of febrile neutropenia G-Lasta Transdermal persistent pain Fentos Poteligeo Rituximab BS [KHK] Chronic idiopathic thrombocytopenic purpura Romiplate Antiallergenic Allelock Antiallergic eyedrops Patanol Ulcerative colitis Asacol Psoriasis vulgaris Dovobet Psoriasis Lumicef Parkinson's disease Nouriast Antiepileptic Depakene Jan - Mar Apr - Jun Jul - Sep Jan - Mar Apr - Jun Jul - Sep Change amount (0.7) (1.5) (0.1) (0.4) (0.1) (0.8) (0.2) (0.4) (0.3) International Technology out-licensing Renal anemia treatment drug Nesp Regpara Agent for decreasing the incidence of febrile neutropenia Neulasta/Peglasta Neutropenia treatment drug Gran X-linked hypophosphatemia (XLH) Crysvita Cancer pain Abstral Cancer pain PecFent Mitomycin-C Chemotherapy-induced nausea and vomiting drug Sancuso Opioid-induced constipation (OIC) Moventig Replacement therapy with testosterone for male hypogonadism Tostran/Fortesta Osteoporosis drug Adcal-D (0.1) (0.4) (0.1) Technology out-licensing * Revenue is classified as Japan or International (other than Japan) based on customer location. * Revenue listed as Technology out-licensing specifies revenue from the upfront payment, milestone revenue, and running royalties revenue that are obtained based on licensing agreements recognizing the granting to third parties the rights for development, manufacturing and sales of the Group's pipeline compounds or the use of technology, etc

8 Ⅴ.R&D Pipeline Filed Approved Area Code Name Generic Name Formulation antibody protein small molecule Mechanism of Action Indication Stage or Licensed As of Sep. 30, 2018 Remarks Nephrology KRN321 Darbepoetin Alfa Long-Acting Erythropoiesis Stimulating Agent Renal Anemia (on Dialysis) Renal Anemia NDA in preparation in CN Filed in ID Kirin-Amgen Oncology Mycosis Fungoides and Sézary Syndrome Cutaneous T-cell Lymphoma Approved in US POTELLIGENT Filed in EU Approved in JP Filed in KR Additional Indication, Dosage and Administration Immunology/A llergy KHK4827 Brodalumab Anti-IL-17 Receptor A Fully Human Antibody Psoriasis Approved in TH Filed in SG Filed in MY Kirin-Amgen Filed in HK Central Nervous System Other KW-6002 Istradefylline KRN23 Burosumab AMG531 Romiplostim Adenosine A 2A Receptor Antagonist Anti-FGF23 Fully Human Antibody Thrombopoietin Receptor Agonist Parkinson's Disease X-linked Hypophosphatemia (XLH) NDA in preparation in US Filed in CA Aplastic Anemia Filed in JP Kirin-Amgen Jointly Developed with Ultragenyx in US and EU Phase Ⅱ, Phase Ⅲ Code Name Area Generic Name Formulation RTA 402 Bardoxolone Methyl Nephrology KHK7580 Evocalcet KHK2375 Entinostat Oncology KHK4083 Mechanism of Action Antioxidant Inflammation Modulator Calcium Receptor Agonist HDAC Inhibitor Anti-OX40 Fully Human Antibody Indication Diabetic Kidney Disease Hypercalcemia In Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism Breast Cancer Adult T-cell Leukemia/Lymphoma Ulcerative Colitis Stage Phase Ⅲ in JP Phase Ⅲ in JP PhaseⅡ in JP Phase Ⅱ in US, EU and others Phase Ⅱ in US, EU and others or Licensed Licensed from Reata Licensed from Mitsubishi Tanabe Pharma Syndax Remarks POTELLIGENT POTELLIGENT Immunology/A llergy KHK4563 Benralizumab Anti-IL-5 Receptor Chronic Obstructive Pulmonary Disease (COPD) Eosinophilic Chronic Rhinosinusitis (ECRS) Phase Ⅲ in JP Phase Ⅱ in JP POTELLIGENT Jointly Developed with AstraZeneca/MedImmune Central Nervous System KHK4827 Brodalumab ASKP1240 Bleselumab KW-6356 Anti-IL-17 Receptor A Fully Human Antibody Anti-CD40 Fully Human Antibody Adenosine A 2A Receptor Antagonist Axial Spondyloarthritis (axspa) Recurrence of Focal Segmental Glomerulosclerosis (FSGS) in de novo kidney transplant recipients HTLV-1 associated myelopathy (HAM) Phase Ⅲ in JP, KR and TW Phase Ⅱ in US Kirin-Amgen Parkinson's Disease Phase Ⅱin JP Jointly Developed with Astellas Phase Ⅲ in JP POTELLIGENT X-linked Hypophosphatemia (XLH) in adult patients Phase Ⅲ in US, CA, EU, JP and KR KRN23 Burosumab Anti-FGF23 Fully Human Antibody X-linked Hypophosphatemia (XLH) in pediatric patients Phase Ⅲ in US, CA, EU, AU, JP and KR Jointly Developed with Ultragenyx in US and EU Other Tumor Induced Osteomalacia(TIO)/Epidermal Nevus Syndrome (ENS) Phase Ⅱ in US Phase Ⅱ in JP and KR AMG531 Romiplostim Thrombopoietin Receptor Agonist Aplastic Anemia Idiopathic (Immune) Thrombocytopenic Purpura PhaseⅡ/Ⅲ in KR Phase Ⅲ in CN Kirin-Amgen Updated since Jun. 30, 2018 (Area, Stage, Filed, Approved, etc.) New Molecular Entity -6-

9 Ⅴ.R&D Pipeline PhⅠ Area Code Name Generic Name Formulation antibody protein small molecule Mechanism of Action Indication Stage or Licensed As of Sep. 30, 2018 Remarks KHK2455 IDO 1 Inhibitor Solid Tumor PhaseⅠ in US Combination with Oncology KHK2823 Anti-CD123 Fully Human Antibody Cancer Phase Ⅰ in UK POTELLIGENT Solid Tumor Phase Ⅰ/Ⅱ in US POTELLIGENT Combination with Nivolumab (Jointly Developed with Bristol-Myers Squibb) Immunology/ Allergy KHK4083 KHK4827 Brodalumab Anti-OX40 Fully Human Antibody Anti-IL-17 Receptor A Fully Human Antibody Ulcerative Colitis Atopic Dermatitis Phase Ⅰin JP Phase Ⅰin JP Autoimmune Disease Phase I in JP Kirin-Amgen POTELLIGENT Central Nervous System KHK6640 Anti Amyloid Beta Peptide Antibody Alzheimer's Disease PhaseⅠin EU PhaseⅠin JP Licensed from Immunas Pharma Others KW-3357 Antithrombin Gamma Recombinant Human Antithrombin Disseminated Intravascular Coagulation, Congenital Antithrombin Deficiency Phase Ⅰin EU Updated since Jun. 30, 2018 (Area, Stage, Filed, Approved, etc.) New Molecular Entity Updated since Jun. 30, 2018 (Area, Stage, Filed, Approved, etc.) Filed Approved Area Code Name Generic Name Formulation Mechanism of Action Indication Stage or Licensed Remarks Oncology Immunology/A llergy Other KHK4827 Brodalumab AMG531 Romiplostim Anti-IL-17 Receptor A Fully Human Antibody Thrombopoietin Receptor Agonist Mycosis Fungoides and Sézary Syndrome Cutaneous T-cell Lymphoma Psoriasis Approved in US POTELLIGENT Approved in JP Filed in KR Approved in TH Kirin-Amgen Aplastic Anemia Filed in JP Kirin-Amgen Additional Indication, Dosage and Administration Terminated Area Oncology Code Name Generic Name Formulation Mechanism of Action Indication Solid Tumor Stage Phase Ⅰ in JP or Licensed Remarks POTELLIGENT Combination with Nivolumab (Jointly Developed with Ono Pharmaceutical) -7-

10 <Appendix> Fujifilm Kyowa Kirin Biologics co. Ltd., Pipeline of Biosimilar Code Name Generic Name Stage Remarks As of September 30th 2018 FKB327 Adalimumab (fully human anti-tnf-α monoclonal antibody ) Approved in EU Fujifilm Kyowa Kirin Biologics Co., Ltd. FKB238 Bevacizumab (humanized anti-vegf monoclonal antibody ) Phase Ⅲ in US, Europe and others Centus Biotherapeutics Ltd.(*) * Centus Biotherapeutics Ltd. is a fifty-fifty joint venture between Fujifilm Kyowa Kirin Biologics Co., Ltd. and AstraZeneca. -8-