Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — Kyowa Hakko Kirin — H1 2011 Earnings Presentation

32 slides from Kyowa Kirin's earnings presentation, Aug 2, 2011

  1. Slide 1: Fiscal 2011 Interim Results

    Kyowa Kyowa Hakko Hakko Kirin Kirin Fiscal Fiscal 2011 2011 Interim Interim Results Results (January (January11- - June June30, 30,2011) 2011) President & CEO Yuzuru Matsuda August 2, 2011 Kyowa Hakko Kirin Co., Ltd Statements on results, forecasts and R&D status contained in this presentation repre

  2. Slide 2: Contents

    Contents Page >> Summary of interim results 2 >> Outline of ProStrakan, accounting treatment 10 >> Full year forecasts 14 >> Pipeline 19 1

  3. Slide 3: Summary of interim results

    KYOWA KIRIN Summary of interim results pyright© Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved

  4. Slide 4: Summary of fiscal 2011 interim results: P&L

     Summary of fiscal 2011 interim results: P&L Operating Ordinary (¥bn) Net sales Net income income income FY 2011 186.3 29.9 30.2 17.7 interim -17.0 +8.2 +7.8 +7.8 Change (-8.4%) (+38.0%) (+35.3%) (+78.9%) FY 2010 203.4 21.6 22.3 9.9 interim *ProStrakan results for the first half of fiscal 2011 are

  5. Slide 5: Pharmaceuticals business

     Pharmaceuticals business FY2010 FY2011 (¥bn) Change interim interim Net sales 103.4 112.5 +9.0 Operating income 17.9 25.1 +7.1 R&D expenses 19.3 20.4 +1.1 *ProStrakan results for the first half of fiscal 2011 are not included in the above figures. 4

  6. Slide 6: Pharmaceuticals business: Change in net sales

     Pharmaceuticals business: Change in net sales ¥bn 120.0 + - 1.7 - 0.2 - 1.2 110.0 12.2 + Nesp +7.7 Allelock +4.2 112.5 100.0 Patanol +3.9 103.4 Fentos +1.2 Regpara +1.0 Espo -3.0 Farmorubicin / Adriacin -1.9 0.00 90.0 FY2010 Revenues from FY2011 Domestic exports and Other / interim Pharmaceuticals

  7. Slide 7: Pharmaceuticals business: Change in operating income

     Pharmaceuticals business: Change in operating income ¥bn 30.0 - -0.2 - -1.1 25.0 8.5 20.0 25.1 17.9 15.0 0.00 0 FY2010 interim Gross SG&A R&D FY2011 interim (excludes R&D operating income profit expenses) expenses operating income 6

  8. Slide 8: Bio-Chemicals and Chemicals businesses

     Bio-Chemicals and Chemicals businesses (¥bn) FY 2010 interim FY2011 interim Change Net sales 44.1 40.3 -3.8 Bio-Chemicals Operating 1.8 2.5 +0.6 income Net sales 61.2 33.5 -27.7 Chemicals* Operating 1.5 2.1 +0.5 income /$ ¥91/$ ¥82/$ -¥9/$ Forex rates vs. ¥ /€ ¥121/€ ¥115/€ -¥6/€ * The Chemicals s

  9. Slide 9: Bio-Chemicals business: Change in net sales

     Bio-Chemicals business: Change in net sales ¥bn Effects of business restructuring -1.5 Daiichi Fine Chemical -1.3 45.0 - 3.8 0 0.0 40.0 44.1 + 40.3 35.0 0.00 0 FY2010 Domestic Overseas FY 2011 interim sales sales interim sales sales 8

  10. Slide 10: Bio-Chemicals business: Change in operating income

     Bio-Chemicals business: Change in operating income ¥bn 3.0 0.0 0.7 -- 0.1 2.5 1.8 0.0 FY2010 SG&A FY2011 Gross R&D operating sales (excludes R&D operating expenses income expenses) income 9

  11. Slide 11: Outline of ProStrakan, accounting treatment

    Outline of ProStrakan, accounting treatment 10

  12. Slide 12: Outline of ProStrakan

     Outline of ProStrakan ￡ｍ ProStrakan results and results forecasts 2011F 2012F 2013F *One-time M&A expenses are not included Sales of core products ￡ｍ 2011F 2012F 2013F 11

  13. Slide 13: ProStrakan: Management policy and strategy

     ProStrakan: Management policy and strategy Europe sales force KHK approx. 15  Governance ProStrakan approx. 150  2 KHK executives will join the ProStrakan ProStrakan: In-house sales network board ProStrakan: JV and alliances  2 KHK executives based in the UK will join the ProStrakan Executive C

  14. Slide 14: ProStrakan: Corporate merger accounting treatment

     ProStrakan: Corporate merger accounting treatment Initial balance sheet (provisional accounting treatment as of the assumed acquisition date June 30, 2011) Balance sheet after valuation of intangible assets by Purchase Price Allocation method （Unit: GBP million) Other assets 56.1 Other liabilities

  15. Slide 15: 2011 forecasts

    KYOWA KIRIN 2011 forecasts copyright© Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved ©

  16. Slide 16: 2011 forecasts (including ProStrakan)

     2011 forecasts (including ProStrakan) Operating Ordinary Net (¥ bn) Net sales income income income Fiscal 2011 forecast 342.0 43.5 44.5 25.5 (vs. Jan 28 2011 forecast) (+5.2%) (+17.6%) (+17.1%) (--) Previous fiscal 2011 325.0 37.0 38.0 25.5 forecast (announced Jan 28 2011） Fiscal 2010 results 413.

  17. Slide 17: Pharmaceuticals business 2011 forecasts (including ProStrakan)

     Pharmaceuticals business 2011 forecasts (including ProStrakan) Difference Revised Initial between initial Effects of ProStrakan ¥bn FY2010 2011 YonY 2011 and revised acquisition results forecast change forecast forecasts (1) (2) (2)-(1) (3) (2)-(3) Net sales 210.3 225.0 +14.6 212.0 +13.0 +7.4 Tota

  18. Slide 18: 2011 forecast sales of core pharmaceutical products

     2011 forecast sales of core pharmaceutical products Initial ¥bn Fiscal 2010 Fiscal 2011 forecast YonY change forecast Nesp 41.7 50.8 22%↑ 46.9 Espo 10.8 5.3 51%↓ 4.0 Nesp/Espo 52.6 56.1 7%↑ 50.9 Regpara 9.5 11.1 17%↑ 11.1 Allelock 26.8 29.0 8%↑ 29.8 Patanol 7.5 11.6 55%↑ 10.2 Gran/Neu-up 14.4 14.5

  19. Slide 19: 2011 forecasts (Bio-Chemicals)

     2011 forecasts (Bio-Chemicals) ¥bn Fiscal 2010 Fiscal 2011 Change Sales 84.2 80.0 -4.2 Bio-Chemicals Operating 3.2 3.5 +0.2 Income /$ ¥88/$ ¥82/$ -¥6/$ Forex rates vs ¥ /€ ¥116/€ ¥118/€ +¥2/€ 18

  20. Slide 20: Pipeline

    KYOWA KIRIN Pipeline copyright© Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved ©

  21. Slide 21: Pipeline (Filed/Approved)

     Pipeline (as of August 2, 2011) （Filed/Approved) Stage Code name/ In-house or Category Indication Formulation licensed Remarks Product name Japan Other countries Filed (Adult T-cell KW-0761 Injection In-house POTELLIGENT antibody* April 2011 leukemia/lymphoma) KRN321 Filed Chemotherapy Darbepoetin

  22. Slide 22: Pipeline (Phase II, Phase III)

     Pipeline (as of August 2, 2011) （Phase II, Phase III) Code name/ Stage Category Indication Formulation In-house or Remarks Product Other licensed name Japan countries (Peripheral T-cell POTELLIGENT® antibody Phase I/II lymphoma and in USA cutaneous T-cell KW-0761 was outlicensed to Amgen Inc. in l

  23. Slide 23: Pipeline (Phase II, Phase III) continued

     Pipeline (as of August 2, 2011) （Phase II, Phase III) continued Stage Code name/ In-house or Category Other Indication Formulation licensed Remarks Product name Japan countries ★Pediatric Renal Phase III KRN321 Anemia Injection Kirin-Amgen Launched in Japan for anemia of Darbepoetin CKD patients A

  24. Slide 24: Pipeline (Phase I)

     Pipeline (as of August 2, 2011) （Phase I） Stage Developed in- Code name/ Category Other Indication Formulation house or Remarks Product name Japan licensed countries Phase I/II KW-2450 Cancer Oral In-house in USA Phase I/IIa KRN330 Cancer Injection In-house in USA Phase I/IIa BIW-8962 Cancer Injec

  25. Slide 25: Antibody pharmaceutical pipeline

     Antibody pharmaceutical pipeline (as of August 2, 2011) Overview of Development Pipeline Therapeutic Ph II Filed Preclinical Ph I area KW-0761(CCR4) ATL U.S. (Ph I/II) Japan (Ph II) Japan ATL; Adult T-cell Leukemia-Lymphoma Eleven KRN330(A33) Antibodies U.S. (Ph I/II) Cancer BIW-8962(GM2) (seven U

  26. Slide 26: Licensing-out antibody pharmaceuticals

     Licensing-out antibody pharmaceuticals (as of August 2, 2011) Antibody Target Licensee Reported Stage Remarks Amgen Ph I KW-0761 CCR4 POTELLIGENT® (Except in JP, CN, KR,TW) (AMG 761) MedImmune Ph II KHK4563 IL-5R POTELLIGENT® (Except in Japan, Asia) (MEDI-563） Life Science KW-2871 GD3 Ph II Pharma

  27. Slide 27: POTELLIGENT technology-related alliances

     POTELLIGENT® technology-related alliances (as of August 2, 2011) Product branding alliances Joint development Out licensing Joint development POTELLIGENT® CHOK1SV Technology License (19 companies) Bristol-Myers Squibb Agensys CSL Limited ImmunoCellular Therapeutics, Ltd. *To date seven out-license

  28. Slide 28: Progress with outlicensed compounds

     Progress with outlicensed compounds (as of August 2, 2011) Phase Name Partner Remarks I II III Tivozanib AVEO Cancer (KRN951) Astellas (VEGF receptor inhibitor) KW-2871 Cancer Life Science (Low-fucose antibody) (Anti-GD3 antibody) MEDI-563 Allergy MedImmune (KHK4563:POTELLIGENT®) (Anti-IL-5R antib

  29. Slide 29: Progress with inlicensed compounds

     Progress with inlicensed compounds (as of August 2, 2011) Phase Name Partner Remarks I II III Parkinson’s disease KW-6500 Britannia Filed (Dopamine agonist) Emesis SP-01 Solasia Preparing to file (Serotonin antagonist) Cancer pain KW-2246 Orexo (m-opioid receptor agonist) Gastric cancer ARQ 197 Ar

  30. Slide 30: KW-0761 Update

     KW-0761 Update KW-0761  An anti-CCR4 antibody using enhanced antibody manufacturing technology POTELLIGENT ® developed in-house Hematological cancer: Development update  Japan: ATL (Adult T-cell leukemia/lymphoma)  Ph I: Published in Journal of Clinical Oncology 28:1591-1598  Ph II: Clinical t

  31. Slide 31: Pipeline - Recent news

     Pipeline - Recent news Main items January –July 2011 1/20 KW-6500 （Parkinson’s disease treatment) released results of Phase III trials in Japan  3/11 KRN125 （treatment for neutropenia during chemotherapy) released start of Phase III trials in Japan  4/13 Launch of ROMIPLATE® [250 mcg] for subcu

  32. Slide 32: Inquiries: Corporate Communications Department

    If you have any inquiries regarding this presentation please call: Corporate Communications Department, Kyowa Hakko Kirin Co., Ltd Tel: 03-3282-0009

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