Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — Kyowa Hakko Kirin — FY2016 Earnings Presentation

41 slides from Kyowa Kirin's earnings presentation, 2017

  1. Slide 1: Results Presentation Fiscal 2016

    Results Presentation Fiscal 2016 Kyowa Hakko Kirin Co., Ltd. © Kyowa Hakko Kirin Co., Ltd.

  2. Slide 2: Agenda

    Agenda FY 2016 Highlights Nobuo Hanai, Ph. D. President and CEO Financial review 2017 Forecasts Kazuyoshi Tachibana, Managing Executive Officer R & D review Business Topics Nobuo Hanai, Ph. D. President and CEO © Kyowa Hakko Kirin Co., Ltd. 2

  3. 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

  4. Slide 4: FY 2016 Highlights

    FY 2016 Highlights In FY2016, sales and profits declined in the Pharmaceuticals and Bio-Chemicals businesses YoY due to the drug price revision, yen appreciation and increased R&D expenses. FY2016 business plan was largely achieved.  Despite well-performing sales of the new products, including G-La

  5. Slide 5: Financial review

    Financial review © Kyowa Hakko Kirin Co., Ltd. 5

  6. Slide 6: Summary of 2016 results (consolidated)

    Summary of 2016 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 yen appreciation. FY2015 FY2016 FY2016 Rate of （Unit: ¥bn） Change results results forecast progress Net s

  7. Slide 7: Summary of FY2016 consolidated results: Analysis of YoY profit changes

    Summary of FY2016 consolidated results: Analysis of YoY profit changes 2016 net profit: Analysis of YoY changes (¥bn)  Decrease in impairment loss + ¥5.4bn  Gain on sale of fixed assets + ¥2.1bn  Gain on sales of investment securities - ¥6.3 -11.1  Equity in losses of affiliates - -16.9 ¥2.3bn 

  8. Slide 8: Summary of FY2016 financial results by segment

    Summary of FY2016 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 expenses. In the Bio-Chemicals businesses, sales and profits declined due t

  9. Slide 9: Pharmaceuticals business: FY2016 Analysis of YoY changes

    Pharmaceuticals business: FY2016 Analysis of YoY changes Net sales Operating income FY2015 results 279.2 FY2015 results 36.2 Domestic sales (parent) - 4.3 Gross profits - 14.0 Technology licensing (parent) - 6.2 SG&A (excl. R&D + 6.4 Overseas sales expenses） (including KKI*) - 4.1 R&D expenses - 2.2

  10. 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 Change Reason for change information r

  11. Slide 11: Bio-Chemicals business: FY2016 Analysis of YoY profit

    Bio-Chemicals business: FY2016: Analysis of YoY profit Net sales Operating income FY2015 results 88.8 FY2015 results 8.1 Overseas sales - 4.1 Gross profits Pharmaceutical and - 0.6 - 3.3 health food materials SG&A (excl. R&D Mail order sales, etc. + 0.6 expenses) + 0.5 Kyowa Pharma Chemical - 1.1 R&

  12. Slide 12: 2017 Forecasts

    2017 Forecasts © Kyowa Hakko Kirin Co., Ltd. 12

  13. Slide 13: FY2017 consolidated forecasts

    FY2017 consolidated forecasts We forecast an increase in sales due to the licensing revenues and growth of the new products in Japan and overseas, and an increase in profits due to the reduction in costs for late-stage development products, despite continuing aggressive R&D investment. Change (Unit:

  14. Slide 14: Summary of FY2017 consolidated forecasts: Analysis of YoY profit changes

    Summary of FY2017 consolidated forecasts: Analysis of YoY profit changes (¥bn) FY2017 net income forecast: Analysis of YoY changes Pharmaceuticals - ¥0.9bn Bio-Chemicals - ¥1.0bn Gain on sale of fixed assets - ¥3.1bn + 5.5 - 2.1 + 0.2 - 3.8 + 0.3 + 0.6 Pharmaceuticals + ¥3.6bn 18.6 Increase in licen

  15. Slide 15: Pharmaceuticals business: FY2017 forecasts

    Pharmaceuticals business: FY2017 forecasts FY2016 FY2017 (Unit: ¥bn) Change results forecasts Net sales 263.2 264.0 0.7 (+0%) Operating income 26.3 29.0 2.6 (+10%) Operating margin [10%] [11.0%] Operating income YoY change (+)  Increase in licensing revenue and strong FY2016 results 26.3 sales of n

  16. Slide 16: Bio-Chemical business: FY2017 forecasts

    Bio-Chemical business: FY2017 forecasts FY2016 FY2017 (Unit: ¥bn) Change results forecasts Net sales 83.6 83.0 - 0.6 (-1%) Operating income 5.3 6.0 0.6 (+ 13%) Operating margin [6.4%] [7.2%] Operating income YoY change (+)  Increase in gross profit margin due to growth FY2016 results 5.3 in sales o

  17. Slide 17: Shareholder returns policy

    Financial strategy / Shareholder return policy Shareholder returns policy  Dividend payout ratio From 2016 to 2018, pay out constant dividends in compliance with 2016-2020 Mid-Term Business Plan, which set a target dividend payout ratio of 40% on the basis of the net profit before amortization of g

  18. Slide 18: R&D review

    R&D review © Kyowa Hakko Kirin Co., Ltd. 18

  19. Slide 19: Key development events in 2016: Domestic

    Key development events in 2016 Domestic:  Announcement of results of interim efficacy analysis of Phase 2 clinical study of RTA 402 targeting chronic kidney disease with type-2 diabetes (May)  Initiation of Phase 2 study of KHK4563 targeting eosinophilic chronic rhinosinusitis (June)  Approval re

  20. Slide 20: Key development events in 2016: Overseas

    Key development events in 2016 Overseas:  Initiation of Phase 1/2 trials of nivolumab (Bristol-Myers Squibb) 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 results fro

  21. Slide 21: Key development events in 2016: Overseas (cont.)

    Key development events in 2016 Overseas (cont.):  Initiation of Phase 1 study of KHK2455 in combination with KW-0761 targeting solid tumors (October, U.S.)  Initiation of Phase 3 study of KRN23 targeting pediatric patients with X-Linked Hypophosphatemia (October in North America, EU, Japan, Korea

  22. Slide 22: Key domestic development updates: KW-6356

    Key domestic development updates KW-6356 Development stage Country/ (Scheduled trial completion date) Estimated Indication region Phase 2 enrollment 2 Parkinson’s disease Japan (2018/12) 150 Estimated no. of patients: Japan: approx. 160,000 1 patients 1 Ministry of Health, Labour and Welfare: 2014 P

  23. Slide 23: KW-6356: Target product profile

    KW-6356: Target product profile Mode of Action: Non-dopaminergic PD* medication based on A2A receptor antagonism Early stage: PD medication used as monotherapy or adjunct therapy for improving motor symptoms Advanced stage: PD medication used as adjunct therapy for improving motor symptoms and motor

  24. Slide 24: KW-6356: Phase II clinical trial

    KW-6356: Phase II clinical trial KW-6353 Phase II Study Design: Title: A Study of KW-6356 in Subject With Early PD (double-blind, placebo-controlled study in patients* with early PD) KW-6356 High dose Allocation KW-6356 Low dose Placebo Primary Outcome Measures: Change from baseline in MDS-UPDRS Par

  25. Slide 25: Key global development updates (1): KW-0761 (hematological cancer)

    Key global development updates (1) 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 (2016/11) 71 4 Relapsed/ CTCL refractory U.S., Europe, J

  26. Slide 26: Key global development updates (2): KW-0761 (solid tumor)

    Key global development updates (2) KW-0761 (solid tumor) Development stage Country/ ConcomitantDevelopment Country/Concomitant stage (Scheduled trial completion date) Estimated Estimated Indication Indication region Drug (Scheduled trial completion date) Partner Partner enrollment region Drug enroll

  27. Slide 27: Key global development updates (3): KW-6002

    Key global development updates (3) KW-6002 1 Development stage (Scheduled trial completion date) Estimated Indication Country/region enrollment Phase 3 Application 4 Parkinson’s disease U.S., Europe, others 2016/10 613 Estimated no. of patients: Japan: approx. 160,000 2 Estimated no. of treatable pa

  28. Slide 28: Key global development updates (4): KRN23

    Key global development updates (4) KRN23 Development stage Development stage (Scheduled trial completion date) Estimated Indication Country/region trial completion date) Partner Estimated Indication Country/region (Scheduled Phase 2 Phase 3 Partner enrollment enrollment Phase 2 Phase 3 U.S., Europe

  29. Slide 29: Key global development updates (5): KRN23

    Key global development updates (5) 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.S. (2016/

  30. Slide 30: Business Topics

    Business Topics © Kyowa Hakko Kirin Co., Ltd. 30

  31. Slide 31: Establishment of Kyowa Kirin Frontier Co., Ltd.

    Business Topics  Establishment of Kyowa Kirin Frontier Co., Ltd. 開発段階 ()は試験終了予定 試験予定 適応症 国・地域 パートナー 症例数 フェーズ2 フェーズ3 © Kyowa Hakko Kirin Co., Ltd. 31

  32. Slide 32: List of acronyms

    List of acronyms ATL Adult T-cell Leukemia/Lymphoma CCR4 Chemokine (C-C motif) Receptor 4 CTCL Cutaneous T-Cell Lymphoma ENS Epidermal Nevus Syndrome TIO Tumor Induced Osteomalacia XLH X-linked Hypophosphatemia © Kyowa Hakko Kirin Co., Ltd. 32

  33. Slide 33: Appendix

    APPENDIX © Kyowa Hakko Kirin Co., Ltd. 33

  34. Slide 34: Appendix: Analysis of FY2016 profit comparison to forecasts

    Appendix: Analysis of FY2016 profit comparison to forecasts (¥bn) 2016 Net income: comparison to forecasts Pharmaceuticals + ¥1.3bn Equity in losses of affiliates + ¥0.4bn Bio-Chemicals + ¥0.8bn + 0.6 - 0.1 + 0.3 + 2.3 + 0.7 18.0 - 2.7 + 2.3 18.6 Pharmaceuticals + ¥2.5bn expected licensing revenue w

  35. Slide 35: Appendix: Pharmaceuticals business FY2017 forecasts: Analysis of YoY changes

    Appendix: Pharmaceuticals business FY2017 forecasts: Analysis of YoY changes Net sales Operating income FY2016 results 263.2 FY2016 results 26.3 Domestic sales (parent) - 7.4 Gross profits + 3.6 Technology licensing + 2.1 (parent) SG&A (excl. R&D expenses） - 2.1 Overseas sales - 1.1 (including KKI)

  36. Slide 36: Appendix: Bio-Chemicals business FY2017 forecasts: Analysis of YoY profit changes

    Appendix: Bio-Chemicals business FY2017 forecasts: Analysis of YoY profit changes Net sales Operating income FY2016 results 83.6 FY2016 results 5.3 Overseas sales + 0.8 Pharmaceutical and Gross profits + 1.7 health food materials + 0.3 SG&A (excl. R&D Mail order sales, etc. + 0.8 expenses) - 0.8 Kyo

  37. Slide 37: Biosimilar products development update

    Biosimilar products development update Development Reference bio medical product Development stage 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 disclosed di

  38. Slide 38: Development progress with outlicensed compounds

    Development progress with outlicensed compounds Phase Name Partner Filing Remarks I II III Advanced Renal Cell Cancer Tivozanib AVEO Europe (VEGF receptor inhibitor) (KRN951) Asthma (Anti-IL-5R antibody) Benralizumab AstraZeneca (KHK4563) (MEDI-563) /MedImmune POTELLIGENT® COPD RGI-2001 REGiMMUNE Ph

  39. Slide 39: FOREX: Average Exchange Rate

    FOREX Average Exchange Rate Average exchange 2015 2016 FY2017 Change rate Results Results Forecast ¥/$ ¥121 ¥109 - ¥12 ¥110 ¥/€ ¥135 ¥121 - ¥14 ¥120 ¥/£ ¥185 ¥150 - ¥35 ¥140 FY2016 Currency Effects (YoY) Segment Currency Net sales Operating income $ - ¥0.24bn + ¥1.20bn Pharmaceuticals business € - ¥

  40. Slide 40: FOREX: Exchange Rate Sensitivity of Earnings Forecast for 2017

    FOREX Estimated Exchange Rate Sensitivity of the (consolidated) Earnings Forecast for 2017* Impact on Impact on Currency Changes Net Sales Operating Income ¥/$ +¥1 -¥0.30bn -¥0.13bn ¥/€ +¥1 -¥0.13bn -¥0.06bn ¥/£ +¥1 -¥0.25bn +¥0.02bn * The values represent estimated cumulative outcome over the conse

  41. Slide 41: Inquiries and Corporate Communications contact

    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

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