Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — Q3 2016 Earnings Presentation
27 slides from Kyowa Kirin's earnings presentation, 2016
Slide 1: Results Presentation Fiscal 2016 Third Quarter
Results Presentation Fiscal 2016 Third Quarter (January 1, 2016 – September 30, 2016) Kyowa Hakko Kirin Co., Ltd. © Kyowa Hakko Kirin Co., Ltd.
Slide 2: Agenda
Agenda FY 2016 Q3 Highlights Financial review Kazuyoshi Tachibana, Tachibana Managing Executive Officer R & D review Yoichi Sato,, Managing g g Executive Officer,, Vice President Head R&D Division Q & A session i © Kyowa Hakko Kirin Co., Ltd. 2
Slide 3: Forward-looking statements
Forward-looking statements This document contains certain forward-looking statements relating to such items as the companyʼs (including its domestic and overseas subsidiaries) forecasts, targets and plans. These forward-looking statements are based upon information available to the company at the pr
Slide 4: FY 2016 Q3 highlights
FY 2016 Q3 highlights In Q3 of FY 2016, sales and profits declined in the Pharmaceuticals and Bio-Chemicals businesses YoY. The consolidated sales and profits decreased YoY, although they saw a steady progress in line with 2016 business plan. Despite well-performing sales of REGPARA® and the new p
Slide 5: Financial review
Financial review © Kyowa Hakko Kirin Co., Ltd. 5
Slide 6: Summary of 2016 Q3 results (consolidated)
Summary of 2016 Q3 results (consolidated) Despite strong sales of new products, the consolidated sales and profits declined due to the reduced licensing revenue, increased R&D expense and continued currency effects of the strong yen. FY2015 Q3 FY2016 Q3 FY2016 Rate of （Unit: ¥bn） Change results resu
Slide 7: Summary of FY2016 Q3 consolidated results: Analysis of YoY profit changes
Summary of FY2016 Q3 consolidated results: Analysis of YoY profit changes (¥bn) 2016 Q3 net profit: Analysis of YoY changes Pharmaceuticals - ¥12.6bn -9.5 95 Kyowa Hakko Kirin - ¥12.4bn (decrease in licensing revenue, etc.) Bio-Chemicals - ¥2.4bn Kyowa Hakko Bio - ¥2.0bn ¥2 0bn -14.5 Equity in
Slide 8: Summary of FY2016 Q3 financial results by segment
Summary of FY2016 Q3 financial results by segment In the Pharmaceuticals business, despite strong sales of new products, the sales and profits declined due to the drug price revision, reduced licensing revenue, and increased R&D and other expenses expenses. In the Bio-Chemicals businesses, sales and
Slide 9: Pharmaceuticals business: FY2016 Q3 Analysis of YoY changes
Pharmaceuticals business: FY2016 Q3 Analysis of YoY changes Net sales Operating income FY2015 Q3 results 208.7 FY2015 Q3 results 34.9 Domestic D ti sales l - 1.3 13 (parent) Gross profits - 12.6 Technology licensing (parent) - 7.2 SG&A (excl. R&D expenses） + 2.2 Overseas sales (including KKI*) - 2.1
Slide 10: Pharmaceuticals business: Domestic sales of key products
Pharmaceuticals business: Domestic sales of key products Despite the increased sales of new products, the sales of domestic pharmaceutical products decreased YoY due to the impact of the drug price revision, etc. Product name, FY2015 FY2016 FY2016 Rate of other Q3 Q3 Change Reason for change informa
Slide 11: Bio-Chemicals business: FY2016 Q3: Analysis of YoY profit
Bio-Chemicals business: FY2016 Q3: Analysis of YoY profit Net sales O Operating i income i FY2015 Q3 results 67.1 FY2015 Q3 results 6.4 Overseas sales - 2.0 20 Gross profits - 2.4 Pharmaceutical and health food materials - 0.1 SG&A (excl. R&D Mail order sales, etc. + 0.4 expenses) + 0.7 Kyowa Pharma
Slide 12: R&D review
R&D review © Kyowa Hakko Kirin Co., Ltd. 12
Slide 13: Key development events in 2016 Domestic
Key development events in 2016 Domestic: Announcement of results of interim efficacy y analysis y of Phase 2 clinical study y of RTA 402 targeting chronic kidney disease with type-2 diabetes (May) Initiation of Phase 2 study of KHK4563 targeting eosinophilic chronic rhinosinusitis (June) Appro
Slide 14: Key development events in 2016 Overseas
Key development events in 2016 Overseas: Initiation of Phase 1/2 trials of Nivolumab ((Bristol-Myers y Squibb) q ) in combination with KW-0761 targeting solid tumors (February, U.S.) Announcement of results from Phase 3 trials of Benralizumab/KHK4563 targeting asthma (May) Announcement of resu
Slide 15: Key development events in 2016 Overseas (cont.)
Key development events in 2016 Overseas (cont.): Initiation of Phase 1 study y of KHK2455 in combination with KW-0761 targeting g g solid tumors (October, U.S.) Note: Listed events were completed between January 23, 2016 and October 21, 2016. © Kyowa Hakko Kirin Co., Ltd. 15
Slide 16: Key global development updates (1) KW-0761 (hematological cancer)
Key global development updates (1) KW-0761 (hematological cancer) 1 Development p stage g Country/ (Scheduled trial completion date) Estimated E ti t d Indication enrollment region Phase 2 Phase 3 Application 4 Relapsed/ ATL U.S., Europe, others 2 (2016/11) 71 refractory 5 Relapsed/ CTCL U.S., Europ
Slide 17: Key global development updates (2) KW-0761 (solid tumor)
Key global development updates (2) KW-0761 (solid tumor) Development stage ConcomitantDevelopment Country/Concomitant Country/ p stage g (Scheduled trial completion date) Estimated Estimated I Indication di ti Indication region Drug (Scheduled trial completion date) Partner P t Partner enrollment re
Slide 18: Clinical study of KHK2455 (IDO inhibitor) combined with KW-0761 was started
Clinical study of KHK2455 (IDO inhibitor) combined with KW-0761 was started IDO：The enzyme is involved in inhibition of cytotoxic T cells and activation of regulatory T cells by mediating degradation of Trp to Kyn. Antigen Presenting Cell Treg Cell KW-0761/ KHK2455 CCR4 mogamulizumab (2) Activation
Slide 19: Key global development updates (3) KW-6002
Key global development updates (3) KW-6002 1 Development p stage g (Scheduled trial completion date) Estimated Indication Country/region enrollment Phase 3 Application 4 North America Parkinson’s disease Europe, Others (2016/11) 609 Estimated no. of patients: Japan: approx. 160,000 2 Estimated no. o
Slide 20: Key global development updates (4) KRN23
Key global development updates (4) KRN23 Development stage Development ((Scheduled p p stage trial completion g ) date) Estimated IIndication di ti Country/region C t / i (Scheduled trial completion date) Partner P Partner t Estimated Indication Country/region Phase 2 Phase 3 enrollment enrollment P
Slide 21: Key global development updates (5) KRN23
Key global development updates (5) KRN23 Development stage Development ((Scheduled p p stage trial completion g ) date) Estimated IIndication di ti Country/region C t / i (Scheduled trial completion date) Partner P Partner t Estimated Indication Country/region Phase 2 Phase 3 enrollment enrollment P
Slide 22: List of acronyms
List of acronyms ADCC Antigen Dependent Cellular Cytotoxicity ATL Adult T-cell Leukemia/Lymphoma CCR4 Ch Chemokine ki (C-C (C C motif) tif) Receptor R t 4 CTCL Cutaneous T-Cell Lymphoma ENS Epidermal Nevus Syndrome TIO Tumor Induced Osteomalacia XLH X-linked Hypophosphatemia © Kyowa Hakko Kirin Co.,
Slide 23: APPENDIX
APPENDIX © Kyowa Hakko Kirin Co., Ltd. 23
Slide 24: Biosimilar products development update
Biosimilar products development update Development Reference bio medical p product Development p stage g Country/region code Generic name Brand name Phase 1 Phase 2 Phase 3 1 FKB327 Adalimumab HUMIRA U.S., others United 2 FKB238 Bevacizumab Avastin Kingdom Not Not Not Not Determined disclosed disclo
Slide 25: Development progress with outlicensed compounds
Development progress with outlicensed compounds Phase Name Partner Filing Remarks I II III Advanced Renal Cell Cancer Tivozanib AVEO EU (VEGF receptor inhibitor) (KRN951) Asthma ((Anti-IL-5R antibody) y) Benralizumab AstraZeneca (KHK4563) (MEDI-563) /MedImmune POTELLIGENT® COPD Midatech Pharma KRN55
Slide 26: FOREX Average Exchange Rate FY2016 Q3 Currency Effects (YoY)
FOREX Average Exchange Rate FY2016 Average exchange 2015 Q3 2016 Q3 Change g Forecast rate Results Results released on 29/7 ¥/$ ¥120 ¥111 - ¥9 ¥109 ¥/€ ¥135 ¥123 - ¥12 ¥121 ¥/£ ¥186 ¥156 - ¥30 ¥151 FY2016 Q3 Currency Effects (YoY) Segment Currency Net sales Operating income $ - ¥0.14bn ¥0 14bn + ¥0.
Slide 27: Contact: Corporate Communications Department
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value l ththrough h th the pursuit it off advances d iin lif life sciences i and d technologies. If you h have any iinquiries i i regarding di this thi presentation t ti