Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — Q2 2017 Earnings Presentation
28 slides from Kyowa Kirin's earnings presentation, 2017
Slide 1: Result Presentation Fiscal 2017 Interim
Result Presentation Fiscal 2017 Interim Kyowa Hakko Kirin Co., Ltd. © Kyowa Hakko Kirin Co., Ltd.
Slide 2: Agenda
Agenda FY2017 Q2 Highlights Nobuo Hanai, Ph.D. President, Chief Executive Officer Financial Review Kazuyoshi Tachibana Director, Managing Executive Officer R&D Review Nobuo Hanai, Ph.D. President, Chief Executive Officer Q&A © Kyowa Hakko Kirin Co., Ltd. 2
Slide 3: Forward-looking Statement
Forward-looking Statement This document contains certain forward-looking statements relating to such items as the company’s (including its domestic and overseas subsidiaries) forecasts, targets and plans. These forward-looking statements are based upon information available to the company at the pre
Slide 4: Summary of Q2 Consolidated Results
Summary of Q2 Consolidated Results 2016Q2 2017Q2 Change Results Results • Benralizumab-related licensing revenue (↑) Net Sales 174.0 175.6 ＋1.6 ( +1%) • Drug price revision and generics’ penetration (↓) Operating • Benralizumab-related Income 15.3 24.1 ＋8.7 (+57%) licensing revenue (↑) [8.8%] [13.7%
Slide 5: Financial Review
Financial Review © Kyowa Hakko Kirin Co., Ltd. 5
Slide 6: Consolidated: YoY Analysis - Net Profit
Consolidated：YoY Analysis -Net Profit- Net Profit (Jan-Jun) +2.9 billion yen Pharmaceuticals +3.5 Gain on sales of fixed (¥Bn) Bio-Chemicals -0.1 assets -2.2 Gain on forgiveness of debts -1.3 Pharmaceuticals +5.4 Bio-Chemicals -0.0 © Kyowa Hakko Kirin Co., Ltd. 6
Slide 7: Summary of Q2 Results by Segment
Summary of Q2 Results by Segment Results in the Pharmaceuticals business increased mainly due to a rise in technology licensing revenue, despite a drop in domestic sales caused by the drug price revision and generics’ penetration Bio-Chemicals business declined due to unfavorable overseas sales
Slide 8: Pharmaceuticals: YoY Analysis - Sales
Pharmaceuticals: YoY Analysis -Sales- Domestic Drug Sales -4.0 +3.4 billion yen • Our key product NESP decreased due to the drug price revision. (incl. forex effect -2.9) • Long-listed products such as ALLELOCK and Coniel also decreased due to the market penetration of generic drugs. (¥Bn) • New p
Slide 9: Pharmaceuticals: YoY Analysis - Operating Income
Pharmaceuticals: YoY Analysis -Operating Income- +9.0 billion yen (incl. forex effect +0.3) Gross Profit +5.4 (incl. forex effect -2.3) (¥Bn) • Mainly due to the increase in technology licensing revenue. SG&A expenses +1.0 (incl. forex effect +2.2) • In real terms excluding the forex effect, KKI
Slide 10: Pharmaceuticals: KHK's Sales by Product
Pharmaceuticals: KHK’s Sales by Product Domestic drug sales decreased due to sluggish sales of the key product NESP and long-listed products Significant increase in technology licensing revenue came mainly from benralizumab 2016Q2 2017Q2 2017Q4 Progress Product Change Reason Results Results Fore
Slide 11: Bio-Chemicals: YoY Analysis - Sales
Bio-Chemicals: YoY Analysis -Sales- -1.4 billion yen Overseas Sales -1.3 (incl. forex effect -0.5) (incl. forex effect -0.5) • Americas -0.6 (incl. forex effect -0.0): Decreased in health-food materials and amino acids for cell culture mediums. (¥Bn) • Europe -0.2 (incl. forex effect -0.3): Slight
Slide 12: Bio-Chemicals: YoY Analysis - Operating Income
Bio-Chemicals: YoY Analysis -Operating Income- -0.1 billion yen (incl. forex effect -0.2) (¥Bn) Gross Profit -0.0 (incl. forex effect -0.2) • Increased in real terms excluding the forex effect, reflecting steady growth in the domestic business. • No big impact arising from the fall in Kyowa Engine
Slide 13: Revision to Full-Year Forecast
Revision to Full-Year Forecast Pharmaceuticals business is expected to drift upward mainly due to favorable sales and SG&A underspent Bio-Chemicals is not expected to change from the initial plan 2017Q4 2017Q4 2016Q4 Initial Forecast Revised Forecast Change Results (31-Jan-17) (28-Jul-17) Net Sa
Slide 14: Revision to Full-Year Forecast (Main Reasons)
Revision to Full-Year Forecast (Main Reasons) Decrease in equity Increase in gain on Increase in domestic loss (FKB) sales of PPE drug sales (¥Bn) Adjustment of R&D Increase in profit expenses etc. before income tax 14 © Kyowa Hakko Kirin Co., Ltd.
Slide 15: R&D Review
R&D Review © Kyowa Hakko Kirin Co., Ltd. 15
Slide 16: Key development events in 2017: Domestic
Key development events in 2017 Domestic: Announcement of top-line results of phase 3 clinical study of evocalcet (KHK7580) for the treatment of secondary hyperparathyroidism (January) and application for approval (April) Application for approval of benralizumab (KHK4563) for the treatment of ast
Slide 17: Key development events in 2017: Overseas
Key development events in 2017 Overseas: Approval received for darbepoetin alfa (KRN321) for the treatment of anemia with myelodysplastic syndrome (February in Singapore and May in Malaysia) Application for approval of brodalumab (KHK4827) for the treatment of psoriasis (February in Taiwan and J
Slide 18: Key development events in 2017: Overseas (cont.)
Key development events in 2017 Overseas (cont.): Announcement of positive results of phase 3 clinical study of burosumab (KRN23) for the treatment of adult X-Linked Hypophosphatemia (April in the U.S., Europe, Canada, Japan, and Korea) Initiation of phase 3 clinical study of KHK4827 (brodalumab)
Slide 19: Key global development updates (1): mogamulizumab hematological cancer
Key global development updates (1) mogamulizumab/KW-0761 (hematological cancer) 1 Development stage Country/ (Scheduled trial completion date) Estimated Indication enrollment region Phase 2 Phase 3 Application 3 Relapsed/ ATL refractory U.S., Europe, others (2017/12) 71 4 Relapsed/ CTCL refractory U
Slide 20: Key global development updates (2): mogamulizumab solid tumor
Key global development updates (2) mogamulizumab/KW-0761 (solid tumor) Development stage Country/ ConcomitantDevelopment Country/Concomitant stage (Scheduled trial completion date) Estimated Estimated Indication region Indication Drug (Scheduled trial completion date) Partner Partner enrollment regi
Slide 21: Key global development updates (3): burosumab
Key global development updates (3) burosumab/KRN23 Development stage Development stage (Scheduled trial completion date) Estimated Indication Indication Country/region Country/region (Scheduled trial completion date) Partner Partner Estimated enrollment Phase 2 Phase 3 enrollment Phase 2 Phase 3 U.S
Slide 22: Key global development updates (4): burosumab
Key global development updates (4) burosumab/KRN23 Development stage Development stage (Scheduled trial completion date) Estimated Indication Country/region(Scheduled trial completion date) Partner Estimated Indication Country/region Phase 2 Phase 3 Partner enrollment enrollment Phase 2 Phase 3 3 U.
Slide 23: Appendix
Appendix © Kyowa Hakko Kirin Co., Ltd. 23
Slide 24: Development schedule of major late-stage pipeline
Development schedule of major late-stage pipeline * ：NDA holder is AstraZeneca + ：Estimated time of regulatory decisions Generic name Country/ Indication 2017 2018 2019~ Code region bardoxolone methyl diabetic kidney Japan Phase 2 Phase 3 RTA 402 disease U.S. +* asthma Europe +* benralizumab Japan f
Slide 25: Biosimilar products development
Biosimilar products development Development Reference bio medical product Development stage Country/region code Generic name Brand name Phase 2 Phase 3 Application FKB327 adalimumab HUMIRA U.S., others 1 FKB238 bevacizumab Avastin U.S., Europe, others Not Not Not Not disclosed disclosed disclosed di
Slide 26: List of acronyms
List of acronyms ATL Adult T-cell Leukemia/Lymphoma COPD Chronic Obstructive Pulmonary Disease CTCL Cutaneous T-Cell Lymphoma ENS Epidermal Nevus Syndrome HTLV-1 Human T-cell Leukemia Virus Type 1 ITP Idiopathic (immune) Thrombocytopenic Purpura TIO Tumor Induced Osteomalacia XLH X-linked Hypophosph
Slide 27: FOREX Information
FOREX Information Average FOREX Rate [¥] 2016Q2 2017Q2 2017Q4 Currency Result Result Change Revised Forecast USD/JPY 114 113 -1 110→112 EUR/JPY 127 122 -5 120→121 GBP/JPY 165 142 -23 140→140 2017Q2 FOREX Effect (YoY) [ ¥Bn ] Segment Currency Sales Operating Income USD -0.05 +0.01 Pharmaceuticals EUR
Slide 28: Inquiries: Corporate Communications Dept
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well- being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. If you have any inquiries regarding this presentation, please call: Corporate Communications De