Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — Kyowa Hakko Kirin — Q3 2014 Earnings Presentation

25 slides from Kyowa Kirin's earnings presentation, Oct 28, 2014

  1. Slide 1: Results Presentation Fiscal 2014 Third Quarter

    Results Presentation Fiscal 2014 Third Quarter (January 1, 2014 – September 30, 2014) Kyowa Hakko Kirin Co., Ltd. October 28, 2014

  2. Slide 2: Forward-looking statements

    Forward-looking statements 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 pr

  3. Slide 3: Agenda

    Agenda Financial review Kazuyoshi Tachibana, Managing Executive Officer Topics Kazuyoshi Tachibana, Managing Executive Officer R & D review Toshiyuki Amemiya, Fellow & Director, Clinical Developments Center, Development Functions Unit, R&D Division 3

  4. Slide 4: Financial review

    KYOWA KIRIN Financial review is copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved

  5. Slide 5: Summary of FY2014 Q3 results (consolidated)

    Summary of FY2014 Q3 results (consolidated) Compared to FY2013 Q3, sales and profits declined due to the effects of the drug price revision and market penetration of generics drugs, and a decrease in licensing revenue FY2014 Rate of (Unit: ¥bn) FY2013 Q3 FY2014 Q3 Change forecast* progress Net sales

  6. Slide 6: Analysis of YonY profit changes

    Summary of FY2014 Q3 results (consolidated): Analysis of YonY profit changes Q3 net income: Analysis (¥bn) Pharmaceuticals -¥12.9bn Kyowa Hakko Kirin (parent) -¥15.7bn (drug price revision -¥6.4bn, Biosimilars-related -¥5.0bn, return of Busuflex development and sales rights -¥2.1bn, decline in sales

  7. Slide 7: Summary of FY2014 Q3 financial results by segment

    Summary of FY2014 Q3 financial results by segment In the Pharmaceuticals business, sales and profits declined due to effects of the drug price revision In the Bio-Chemicals business, sales and profits increased due to expansion of generic APIs and other products (Unit: ¥bn) FY2013 Q3 FY2014 Q3 Chang

  8. Slide 8: Pharmaceuticals business: FY2014 Q3 analysis of YonY profit changes

    Pharmaceuticals business: FY2014 Q3: Analysis of YonY profit changes ～ ～ ～ ～ ～ Net sales Operating income ～ ～ 前年同期 FY2013 Q3 192.7 ～ FY2013 前年同期 Q3 36.9 ～ ～ 国内医薬品 ～ ～ Domestic sales （単体）増減 (parent) - 7.8 売上総利益 輸出（単体） Gross 増減 profits - 12.9 Exports (parent) 増減 + 1.0 技術収入他 SG&A 販管費 Technology licensi

  9. Slide 9: Pharmaceuticals business: Domestic sales of key products

    Pharmaceuticals business: Domestic sales of key products Sales of key product NESP® performed strongly, but were impacted by the effects of the drug price revision and penetration of generics Product name/ FY2013 Q3 FY2014 Q3 Change Reason for change Rate of Exports/ results1 results1 progress2 Tech

  10. Slide 10: Bio-Chemicals business: FY2014 Q3 analysis of YonY profit changes

    Bio-Chemicals business: FY2014 Q3: Analysis of YonY profit changes Net sales Operating income ～ ～ 前年同期 FY2013 Q3 61.5 前年同期 4.5 ～ ～ FY2013 Q3 ～ ～ ヘルスケア Healthcare (parent) （単体）増減 +0.1 売上総利益 医薬・工業原料 増減profits Gross +2.1 Pharma/ （単体）増減 industrial use (parent) +0.0 販管費 海外売上 Overseas sales 増減 +1.2 （除研開費）

  11. Slide 11: Topics

    KYOWA KIRIN TODpICS copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 41

  12. Slide 12: FY2014 Q3 Topics

    FY2014 Q3 Topics 1. KW-0761 development tie-ups with goal of maximizing product value - AstraZeneca (July) MEDI4736 / Tremelimumab - Pfizer (September) PF-05082566 2. ProStrakan completes acquisition of Archimedes (August) 3. Sustained-duration G-CSF product G-Lasta® approval in Japan (September) 12

  13. Slide 13: KW-0761 development tie-up expansion

    1. KW-0761 development tie-up expansion KW-0761 development tie-ups with goal of maximizing product value advance Rapidly explore opportunities in the tumor immunity field Expected therapeutic value in combination MEDI4736 immunotherapy ■ KW-0761 + MEDI4736 -Target：Solid tumors -Phase1/1b (plan to r

  14. Slide 14: Business combination accounting treatment of Archimedes

    2. Business combination accounting treatment of Archimedes Opening balance sheet（Provisional accounting treatment as of August 5, 2014) －Balance sheet after appraisal of intangible assets according to the PPA* method （Unit: GBP million) Assets 47.6 Liabilities 25.3 Deferred tax liabilities 24.4 Inve

  15. Slide 15: Approval for G-Lasta in Japan

    3. Approval for G-Lasta ® in Japan Gained approval for G-Lasta ®, the first sustained-duration G-CSF product in Japan Indication: Febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy G-Lasta ® ’s position in the GRAN ® marketplace GRAN® High Capacity Hematopoietic stem-

  16. Slide 16: R&D review

    KYOWA KIRIN R&D review | copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 16

  17. Slide 17: Domestic development and other key updates

    Domestic development and other key updates Product Category name/development Mechanism of action, etc. Stage (timing) / Target number Nephrology KHK7580 Calcium receptor agonist Phase 2 (August)/Secondary hyperparathyroidism Oncology G-Lasta® Sustained-duration G-CSF product Approved (September)/1 O

  18. Slide 18: Global development update (1) KW-0761

    Global development update (1) KW-0761 Indication Country/ Development stage Annual incidence per disease, other region ATL Untreated Japan Re-filing Japan: approx. 1,1001 patients ATL Relapsed/ U.S. Phase 2 Europe, U.S.: Investigating refractory Europe CCR4 positivity was not an inclusion criterion

  19. Slide 19: Global development update (2) KW-6002, KRN23

    Global development update (2) KW-6002 Indication Country/ Development Annual incidence per disease, other region stage Parkinson’s disease NA Phase 3 U.S.: More than 570,0001 patients Europe Special Protocol Assessment agreed with FDA Others KRN23 Indication Country/ Development Annual incidence per

  20. Slide 20: Biosimilars development update

    Biosimilars development update Strong development is proceeding according to initial plan Development Reference medical product Stage number Biosimilar FKB327 Adalimumab (humira) Phase 1 * Biosimilar FKB238 Bevacizumab (avastin) Phase１(in preparation) Biosimilar Not disclosed Not disclosed Determine

  21. Slide 21: Group mission and contact information

    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 Depa

  22. Slide 22: Appendix

    KYOWA KIRIN APPENDIX a copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 22

  23. Slide 23: Appendix: 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 antibody) BenralizuMab AstraZeneca (KHK4563) (MEDI-563) /MedImmune POTELLIGENT® COPD KRN5500 DARA Peripheral neuropathy RGI2001 RE

  24. Slide 24: Appendix: Breakdown of total acquisition cost and acquisition value

    Appendix: Breakdown of total acquisition cost and acquisition value （Archimedes at time of acquisition) Acquired company BS Other liabilities market value Loans payable Loans Assets payable market value Net assets Acquisition value market value Total acquisition cost Reference: Goodwill (ProStrakan

  25. Slide 25: Appendix: FOREX related

    Appendix: FOREX related Period average rate Average FY2013 FY2014 Change 2014 exchange rate Jan-Sept Jan.-Sept Jan-Dec forecast results results ¥104 ¥/$ ¥95 ¥103 +¥8 ¥139 ¥/€ ¥125 ¥140 +¥15 ¥171 ¥/£ ¥147 ¥171 +¥24 FY2014 Q3 currency effects (YoY) Segment Currency Net sales Operating income $ +¥0.6bn

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