Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — Q3 2015 Earnings Presentation
28 slides from Kyowa Kirin's earnings presentation, Oct 28, 2015
Slide 1: Results Presentation Fiscal 2015 Third Quarter
Conference call materials Results Presentation Fiscal 2015 Third Quarter (January 1, 2015 – September 30, 2015) Kyowa Hakko Kirin Co., Ltd. October 28, 2015
Slide 2: 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 3: Agenda
Agenda FY 2015 Q3 Highlights Kazuyoshi Tachibana, Managing Executive Officer Financial review Kazuyoshi Tachibana, Managing Executive Officer R & D review Yoichi Sato, Managing Executive Officer, Vice President, Head of R&D Division Q & A session © 2015 Kyowa Hakko Kirin Co., Ltd. 3
Slide 4: FY 2015 Q3 Highlights
FY 2015 Q3 Highlights In FY2015 Q3, the Pharmaceuticals business and the Bio-Chemicals business both saw an increase in sales and profits resulting in increased sales and profits on a consolidated basis and steady progress in line with full-year plans In the Pharmaceuticals business, new products
Slide 5: Financial review
Financial review © 2015 Kyowa Hakko Kirin Co., Ltd. 5
Slide 6: Summary of 2015 Q3 results
Summary of 2015 Q3 results Sales and profits increased on year on year on a consolidated basis due to the growth of domestic products and other factors despite increased R&D expenses in the Pharmaceuticals business FY2014 Q3 FY2015 Q3 FY2015 Rate of （Unit: ¥bn） Change results results forecast progre
Slide 7: Summary of FY2015 Q3 consolidated results: Analysis of YoY profit changes
Summary of FY2015 Q3 consolidated results: Analysis of YoY profit changes (¥bn) Q3 net income: Analysis of YoY changes 400 40 Pharmaceuticals -¥8.2bn Kyowa Hakko Kirin (parent) -¥1.7bn (increase in R&D expenses, etc.) ProStrakan -¥5.9bn (Archimedes, currency effects, etc.) 350 35 Bio-Chemicals -¥0.9
Slide 8: Summary of FY2015 Q3 financial results by segment
Summary of FY2015 Q3 financial results by segment In the Pharmaceuticals business, sales and profits increased due to growth of domestic products, in particular new products, and other factors. In the Bio-Chemicals business, growth in amino acids for overseas supplements and infusion-use and others
Slide 9: Pharmaceuticals business: FY2015 Q3 Analysis of YoY profit changes
Pharmaceuticals business: FY2015 Q3: Analysis of YoY profit changes Net sales Operating income FY2014 Q3 results 178.6 FY2014 Q3 results 20.6 Domestic sales +13.3 Gross profits (parent) +22.5 Technology licensing +4.9 SG&A (excl. R&D (parent) expenses） -4.3 Overseas sales +11.5 (including ProStrakan
Slide 10: Pharmaceuticals business: Domestic sales of key products
Pharmaceuticals business: Domestic sales of key products While sales were affected by the drug price revision in the previous year and the market penetration of generics, sales increased year on year as a result of the market penetration of new products and growth of key products such as NESP® Produ
Slide 11: Bio-Chemicals business: FY2015 Q3 Analysis of YoY profit changes
Bio-Chemicals business: FY2015 Q3: Analysis of YoY profit changes Net sales Operating income FY2014 Q3 62.7 FY2014 Q3 5.6 Overseas sales +2.8 Pharma/ industrial Gross profits +1.7 use -1.0 SG&A (excl. R&D -1.1 Healthcare +0.5 expenses) Daiichi Fine Chemical +1.0 R&D expenses +0.1 Other/ Eliminations
Slide 12: R & D review
R & D review © 2015 Kyowa Hakko Kirin Co., Ltd. 12
Slide 13: Key development events timeline (Domestic)
Key development events timeline Domestic: ☑ Initiation of Phase 2 trials of RTA 402 targeting chronic kidney disease with type-2 diabetes (March) ☑ Initiation of Phase 1 trials of Nivolumab (ONO PHARMACEUTICAL/Bristol- Myers Squibb) in combination with KW-0761 (brand name in Japan: POTELIGEO®) targe
Slide 14: Key development events timeline (Overseas)
Key development events timeline Overseas: ☑ Application for marketing authorization of KRN321 (brand name in Japan: NESP®) (February, China) ☑ Initiation of Phase 1 trials of PF-05082566 (Pfizer) in combination with KW- 0761 targeting solid tumors (June, U.S.) ☑ Agreement to collaborate on developme
Slide 15: Key domestic development updates
Key domestic development updates KHK7580: A next generation calcimimetic drug (phase 3 in preparation) Development stage Indication Country/ (Scheduled trial completion date) Estimated enrollment region Phase 2 Phase 3 Application In 2) preparation 600 Secondary In 3) Japan 2015/2 120 hyperparathyro
Slide 16: KHK7580: A next generation calcimimetic drug
KHK7580: A next generation calcimimetic drug [Secondary hyperthyroidism] The parathyroid glands secrete PTH to correct hyperphosphatemia and hypocalcaemia associated with chronic kidney disease. Continued secretion results in parathyroid hyperplasia, and the pathological condition of excessive secre
Slide 17: KHK7580: Phase 3 Study design
KHK7580: Phase 3 Study design KHK7580 Phase 3 clinical study: Randomized, double-blind, intra-subject dose-adjustment, parallel-group study evaluating KHK7580 and cinacalcet hydrochloride for secondary hyperparathyroidism patients receiving hemodialysis. KHK7580 group Allocation Cinacalcet* group *G
Slide 18: Key global development updates (1)
Key global development updates (1) KW-0761 (hematological cancer) Development stage Country/ (Scheduled trial completion date) Estimated Indication enrollment region Phase 2 Phase 3 Application Approval Untreated Japan 2014/122 ATL Relapsed/ Japan 2012/32 refractory U.S., Europe, others1 (2015/12) 7
Slide 19: Key global development updates (2)
Key global development updates (2) KW-0761 (solid tumor) Development stage Country/ Concomitant (Scheduled trial completion date) Estimated Indication Partner enrollment region Drug Phase 1 MEDI4736 (2016/6) 1081 U.S. AstraZeneca or Tremelimumab U.S. PF-05082566 (2018/3) Pfizer 702 Solid ONO PHARMAC
Slide 20: Key global development updates (3)
Key global development updates (3) KW-6002 Development stage Country/ (Scheduled trial completion date) Estimated Indication enrollment region Phase 2 Phase 3 Application Approval Japan 2013/31 Parkinson’s disease North America, (2016/2) 6094 Europe, Others Patient numbers Japan: approx. 140,0002 U.
Slide 21: Key global development updates (4)
Key global development updates (4) KRN23 Development stage Country/ (Scheduled trial completion date) Estimated Indication Partner region Phase 1 Phase 2 Phase 3 enrollment Pediatric U.S., Europe (2017/3) 504 U.S. (2016/9) 255 NA., Europe In Ultragenyx XLH Japan, Korea preparation Pharmaceutical 120
Slide 22: List of acronyms
List of acronyms ATL Adult T-cell Leukemia/Lymphoma CCR4 Chemokine ( C-C motif ) Receptor 4 COPD Chronic Obstructive Pulmonary Disease CTCL Cutaneous T-Cell Lymphoma DIC Disseminated Intravascular Coagulation ENS Epidermal Nevus Syndrome ITP Idiopathic Thrombocytopenic Purpura PTCL Peripheral T-Cell
Slide 23: Group mission and inquiries
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 Dep
Slide 24: APPENDIX
APPENDIX © 2015 Kyowa Hakko Kirin Co., Ltd. 24
Slide 25: Appendix: Biosimilar pharmaceutical products development update
Appendix: Biosimilar pharmaceutical products development update Reference bio medical product Development stage Development Country/ code Generic name Brand name region Phase 1 Phase 2 Phase 3 1 FKB327 Adalimumab HUMIRA U.S., others 2 FKB238 Bevacizumab Avastin United Kingdom Determined Not disclose
Slide 26: Appendix: Name change - Kyowa Pharma Chemical Co., Ltd.
Appendix: Name change - Kyowa Pharma Chemical Co., Ltd. To clarify the responsibilities of a member of the Kyowa Hakko Kirin Group, Daiichi Fine Chemical Co., Ltd. has changed its name to Kyowa Pharma Chemical Co., Ltd. (Effective Oct. 1, 2015) Key products History manufactured 1946: Company founded
Slide 27: Appendix: FOREX related
Appendix: FOREX related Period average rate Average exchange 2014 Q3 2015 Q3 2015 full-year Change Forecast rate Results Results ¥/$ ¥103 ¥120 +¥17 ¥120 ¥/€ ¥140 ¥135 -¥5 ¥133 ¥/£ ¥171 ¥186 +¥15 ¥181 FY2015 Q3 currency effects (YoY) Segment Currency Net sales Operating income Pharmaceuticals $ +¥1.1
Slide 28: Development progress with outlicensed compounds
Development progress with outlicensed compounds Phase Name Partner Remarks I II III Cancer Tivozanib AVEO (VEGF receptor inhibitor) (KRN951) Asthma (Anti-IL-5R Benralizumab AstraZeneca antibody) (KHK4563) (MEDI-563) /MedImmune POTELLIGENT® COPD KRN5500 DARA Peripheral neuropathy RGI-2001 REGiMMUNE P