Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — FY2015 Earnings Presentation
38 slides from Kyowa Kirin's earnings presentation, January 2016
Slide 1: Results Presentation Fiscal 2015
Results Presentation Fiscal 2015 (January 1, 2015 – December 31, 2015) Kyowa Hakko Kirin Co., Ltd.
Slide 2: Agenda
Agenda FY 2015 Highlights Nobuo Hanai, Ph. D. President and CEO Financial review 2016 Forecasts Kazuyoshi Tachibana, Managing Executive Officer R & D review Topics Nobuo Hanai, Ph. D. President and CEO © 2015 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 2015 Highlights
FY 2015 Highlights In FY2015, the final year of the medium-term business plan, consolidated net income increased ¥13.8 billion YoY due to increased sales and profits in both the Pharmaceuticals business and the Bio-Chemicals business In the Pharmaceuticals business, new products G-Lasta®, Dovobet®
Slide 5: Financial review
Financial review © 2015 Kyowa Hakko Kirin Co., Ltd. 5
Slide 6: Summary of 2015 results (consolidated)
Summary of 2015 results (consolidated) Consolidated sales and profits increased YoY due to factors such as growth of domestic pharmaceutical products and despite higher expenses such as R&D costs in the Pharmaceuticals business FY2015 （Unit: ¥bn） FY2014 results FY2015 results Change forecast Net sal
Slide 7: Analysis of YoY profit changes
Summary of FY2015 consolidated results: Analysis of YoY profit changes FY2015 net income: Analysis of YoY changes (¥bn) Pharmaceuticals -¥11.1bn Kyowa Hakko Kirin (parent) -¥3.6bn (Increase in R&D costs, 40 etc.) ProStrakan -¥6.6bn (Archimedes, currency effects, etc.) Bio-Chemicals -¥0.7bn 35 Curren
Slide 8: Summary of FY2015 financial results by segment
Summary of FY2015 financial results by segment In the Pharmaceuticals business, sales and profits increased due to growth of domestic pharmaceutical products, especially new products, and other factors In the Bio-Chemicals business, sales and profits increased due to growth in areas such as amino ac
Slide 9: Pharmaceuticals business: FY2015 analysis of YoY changes
Pharmaceuticals business: FY2015: Analysis of YoY changes Net sales Operating income FY2014 results 253.0 FY2014 results 29.0 Domestic sales (parent) +15.9 Gross profits +18.2 Technology licensing (parent) -2.2 SG&A (excl. R&D expenses） -6.6 Overseas sales +12.7 (including ProStrakan) R&D expenses -
Slide 10: Pharmaceuticals business: Domestic sales of key products
Pharmaceuticals business: Domestic sales of key products Sales increased YoY due to market penetration of new products and growth of key products such as NESP® , and despite the effects of the drug price revision in the previous year and the market penetration of generics Product name, FY2014 FY2015
Slide 11: Bio-Chemicals business: FY2015 analysis of YoY profit changes
Bio-Chemicals business: FY2015: Analysis of YoY profit changes Net sales Operating income FY2014 results FY2014 results 83.9 7.2 Overseas sales +3.6 Gross profits +1.6 Pharmaceutical and -0.5 health food materials SG&A (excl. R&D Consumer products +0.6 expenses) -1.2 Kyowa Pharma Chemical +0.3 R&D e
Slide 12: 2016 Forecasts
2016 Forecasts © 2015 Kyowa Hakko Kirin Co., Ltd. 12
Slide 13: FY2016 consolidated forecasts
FY2016 consolidated forecasts We forecast a decrease in sales due to the effect of the drug price revision and market penetration of generics in Japan, and a decrease in profits as we continue investment in late-stage developments Change (Unit: ¥bn) FY2015 results FY2016 forecasts (%) -13.3 Net sale
Slide 14: Analysis of YoY profit changes (FY2016 forecasts)
Summary of FY2016 consolidated forecasts: Analysis of YoY profit changes FY2016 net income forecast: Analysis of YoY changes (¥bn) 40 Pharmaceuticals -¥10.0bn Kyowa Hakko Kirin (parent) -¥15.1bn (drug price revision, etc.) 35 Bio-Chemicals +¥0.1bn ▲138 -13.7 30 Extraordinary Income -¥7.1bn (Decrease
Slide 15: Pharmaceuticals business: FY2016 forecasts
Pharmaceuticals business: FY2016 forecasts FY2015 FY2016 (Unit: ¥bn) Change results forecasts -11.2 Net sales 279.2 268.0 (-4%) Operating income 36.2 23.0 -13.2 Operating margin [13.0％] [8.6%] (-36%) Operating income YoY change FY2015 results 36.2 Gross profits (+) -10.0 Decrease in in-licensing e
Slide 16: Bio-Chemical business: FY2016 forecasts
Bio-Chemical business: FY2016 forecasts FY2015 FY2016 (Unit: ¥bn) Change results forecasts -1.8 Net sales 88.8 87.0 (-2%) Operating income 8.1 7.0 -1.1 Operating margin [ 9.1%] [ 8.0%] (-14%) Operating income YoY change FY2015 results 8.1 Gross profits (-) +0.1 Increase in sales promotion costs fo
Slide 17: Financial strategy / Shareholder return policy
Financial strategy / Shareholder return policy Maximize corporate value = Maximize shareholder value Shareholder returns policy Planned dividends for period Dividend payout ratio Based on the company’s shareholder Targeting a stable dividend payout ratio of 40% returns policy, the company expect
Slide 18: R & D review
R & D review © 2015 Kyowa Hakko Kirin Co., Ltd. 18
Slide 19: 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 20: 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 21: Key global development updates (1)
Key global development updates (1) KW-0761 (hematological cancer)1 Development stage Country/ (Scheduled trial completion date) Estimated Indication region Phase 2 Phase 3 Application enrollment Relapsed/ ATL refractory U.S., Europe, others2 (2015/12) 704 Relapsed/ CTCL refractory U.S., Europe, Japa
Slide 22: 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 Durvalumab U.S. (2016/6) AstraZeneca 1081 or Tremelimumab U.S. PF-05082566 (2018/3) Pfizer 702 Solid ONO PHARM
Slide 23: 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, (2016/4) 6094 Europe, Others Patient numbers Japan: approx. 140,0002 U.
Slide 24: 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 Ultragenyx XLH (2017/3) 1206 Adult Japan, Korea Pharmaceutica
Slide 25: KRN23: Global development progress
KRN23: Global development progress Achieved results favorable for approval application, launched late- phase clinical studies in Europe, the U.S., Japan, and Korea Study of pediatric patients with XLH Phase 2 study ( Europe, U.S.): 36 patients* received KRN23 and in the 40- week interim results ef
Slide 26: Topics
Topics © 2015 Kyowa Hakko Kirin Co., Ltd. 26
Slide 27: Licensing agreement: biosimilar rituximab
Licensing agreement: biosimilar rituximab KHK has entered into a licensing agreement with Sandoz for the sale of biosimilar rituximab in Japan to strengthen efforts in hematologic cancers, a priority disease area Rituximab Chimeric anti-CD20 monoclonal antibody Sandoz is developing rituximab glo
Slide 28: 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 ENS Epidermal Nevus Syndrome ITP Idiopathic Thrombocytopenic Purpura TIO Tumor Induced Osteomalacia XLH X-linked Hypophosphatemia © 20
Slide 29: Company 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 30: Appendix
APPENDIX © 2015 Kyowa Hakko Kirin Co., Ltd. 30
Slide 31: Summary of FY2015 results by segment vs forecasts
Appendix: Summary of FY2015 financial results by segment and comparison to forecasts In the Pharmaceuticals business, profits decreased due to increased SG&A as a result of product licensing and other factors In the Bio-Chemicals business, profits decreased due to high costs associated with the esta
Slide 32: Analysis of FY2015 profit comparison to forecasts
Appendix: Analysis of FY2015 profit comparison to forecasts 2015 Net income: comparison to forecasts (¥bn) Effects of accounting for 40 Pharmaceuticals -¥3.2bn income tax, etc. Kyowa Hakko Kirin (parent) -¥2.0bn (upfront payment for product licensing, etc.) 35 ProStrakan -¥1.4bn (currency effects, e
Slide 33: Pharmaceuticals business FY2016 forecasts: Analysis of YoY changes
Appendix: Pharmaceuticals business FY2016 forecasts: Analysis of YoY changes Net sales Operating income FY2015 results 279.2 36.2 FY2015 results Domestic sales (parent) -10.4 Gross profits -10.0 Technology licensing (parent) -4.4 SG&A (excl. R&D expenses） +1.1 Overseas sales (including ProStrakan) +
Slide 34: Bio-Chemicals business FY2016 forecasts: Analysis of YoY profit changes
Appendix: Bio-Chemicals business FY2016 forecasts: Analysis of YoY profit changes Net sales Operating income FY2015 results 88.8 FY2015 results 8.1 Overseas sales +0.7 Pharmaceutical and Gross profits +0.1 health food materials -0.9 SG&A (excl. R&D Consumer Products +0.5 expenses) -1.0 Kyowa Pharma
Slide 35: 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 36: POTELLIGENT Technology License
Appendix: POTELLIGENT® Technology License BioWa launches business for the licensing of POTELLIGENT® technology alone, in addition to combined licensing of POTELLIGENT® technology and cell-line business Combined licensing of POTELLIGENT® technology licensing POTELLIGENT® technology and cell- business
Slide 37: Development progress with outlicensed compounds
Appendix: 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) (MEDI-563) /MedImmune (KHK4563) COPD POTELLIGENT® Midatech Peripheral KRN5500 Pharma US neuropa
Slide 38: FOREX related
Appendix: FOREX related Period average rate Average exchange 2014 2015 FY2016 Change Forecast rate Results Results ¥/$ ¥105 ¥121 +¥16 ¥119 ¥/€ ¥140 ¥135 -¥5 ¥137 ¥/£ ¥173 ¥185 +¥12 ¥187 FY2015 currency effects (YoY) Segment Currency Net sales Operating income Pharmaceuticals $ +¥1.1bn -¥0.6bn busine