Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — Kyowa Hakko Kirin — FY2011 Earnings Presentation

35 slides from Kyowa Kirin's earnings presentation, Jan 31, 2012

  1. Slide 1: Kyowa Hakko Kirin Fiscal 2011 Results

    Kyowa Hakko Kirin Fiscal 2011 Results (Fiscal year to December 31, 2011) January 31, 2012 President & CEO Yuzuru Matsuda Kyowa Hakko Kirin Co., Ltd Statements on results, forecasts and R&D status contained in this presentation represent judgments based on information available at the current time. A

  2. Slide 2: Contents

    Contents Page >> Summary of fiscal 2011 results 2 >> 2012 forecast 10 >> Pipeline 16 >> Biosimilar joint venture with Fujifilm 27 >> Business in Asia 30 1

  3. Slide 3: Summary of fiscal 2011 results

    Summary of fiscal 2011 results 2

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

     Summary of fiscal 2011 results: P&L Operating Ordinary (¥bn) Net sales Net income income income FY2011 343.7 46.6 46.7 25.6 -70.0 +1.2 +0.2 +3.4 Change (-16.9%) (+2.7%) (+0.5%) (+15.4%) FY2010 413.7 45.4 46.5 22.1 *ProStrakan results for the first half of fiscal 2011 are not included in the above

  5. Slide 5: Summary of fiscal 2011 results: Pharmaceuticals business

     Summary of fiscal 2011 results: Pharmaceuticals business (¥bn) FY2010 FY2011 Change Net sales 210.3 229.3 +18.9 Operating income 35.8 41.3 +5.4 R&D expenses 40.0 44.5 +4.5 *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) 2,400 240.0 + + -1.3 13 18 -1.8 71 +7.1 220.0 2,200 150 +15.0 2,293 229.3 210.3 2,103 0.0 2,000 Revenues from Domestic FY2010 Pharmaceuticals exports and Overseas sales Other / FY2011 sales licensing eliminations sales (Non-consolidated) (Non-con

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

     Pharmaceuticals business: Change in operating income 億円 (¥bn) 60.0 600 50.0 500 --6.3 63 +16.3 163 --4.5 45 40.0 400 41.3 413 35.8 358 300 0.0 0 FY2010 Gross SG&A R&D FY2011 (excludes R&D operating income profit expenses) expenses operating income 6

  8. Slide 8: Summary of fiscal 2011 results: Bio-Chemicals and Chemicals businesses

     Summary of fiscal 2011 results: Bio -Chemicals and Chemicals businesses (¥bn) FY 2010 FY 2011 Change Net sales Bio- 84.2 77.5 -6.6 Chemicals Operating income 3.2 2.8 -0.3 Net sales 130.0 33.5 -96.4 Chemicals* Operating income 5.6 2.1 -3.5 ¥/$ ¥88/$ ¥80/$ -¥8/$ Forex ¥/€ ¥116/€ ¥111/€ -¥5/€ * The C

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

     Bio-Chemicals business: Change in net sales 億円 (¥bn) 90.0 900 - -4.0 40 80.0 800 - -2.7 27 + 84.2 842 70.0 700 77.5 775 600 0.0 0 FY2010 Domestic Overseas FY 2011 sales sales sales sales 8

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

     Bio-Chemicals business: Change in operating income (¥bn) 億円 40 4.0 -0 -1.2 -12 8 +0.8 2.0 20 32 3.2 2.8 28 2.8 0.0 0 FY2010 SG&A FY2011 Gross R&D operating sales (excludes R&D operating expenses income expenses) income 9

  11. Slide 11: 2012 forecasts

    KYOWA KIRIN 2012 forecasts copyright© Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 10)

  12. Slide 12: 2012 forecasts

     2012 forecasts Net Operating Ordinary Net (¥ bn) sales income income income Fiscal 2012 forecast 326.0 48.0 42.5 20.0 Change (-5.2%) (+3.0%) (-9.1%) (-21.9%) Fiscal 2011 results 343.7 46.6 46.7 25.6 * The Chemicals segment was included in consolidation for the January-March period of fiscal 2011 a

  13. Slide 13: Fiscal 2012 full year forecasts: Pharmaceuticals

     Fiscal 2012 full year forecasts: Pharmaceuticals (¥bn) FY 2011 FY 2012 Change Net sales 229.3 242.0 +12.7 Operating income 41.3 45.7 +4.4 R&D expenses 44.5 42.9 -1.6 12

  14. Slide 14: Fiscal 2012 full year forecasts: Sales of core pharmaceutical products

     Fiscal 2012 full year forecasts: Sales of core pharmaceutical products (¥bn) FY 2011 FY 2012 Change Nesp 56.4 50.5 10.5%↓ Espo 5.3 4.0 24.5%↓ Nesp/Espo 61.8 54.5 11.8%↓ Regpara 11.5 13.1 13.9%↑ Allelock 29.1 29.7 2.1%↑ Patanol 11.4 11.3 0.9%↓ Gran 14.8 13.3 10.1%↓ Fentos 3.1 4.9 58.1%↑ Coniel 19.7

  15. Slide 15: Fiscal 2012 full year forecasts: Bio-Chemicals business

     Fiscal 2012 full year forecasts: Bio-Chemicals business (¥bn) FY 2011 FY 2012 Change Net sales 77.5 78.0 +0.4 Bio-Chemicals Operating 2.8 2.0 -0.9 income /$ ¥80/$ ¥77/$ -¥3/$ Forex /€ ¥111/€ ¥98/€ -¥13/€ 14

  16. Slide 16: Fiscal 2012 full year forecasts: Relative to medium-term plan

     Fiscal 2012 full year forecasts: Relative to medium-term plan Medium-term Current FY2012 (¥bn) plan forecast Difference Sales 225.0 242.0 +17.0 Pharmaceuticals OP 36.4 45.7 +9.3 R&D expense 40.0 42.9 +2.9 Sales 88.0 78.0 -10.0 Bio-Chemicals OP 8.4 2.0 -6.4 Sales 147.0 － -147.0 Chemicals OP 7.0 － -

  17. Slide 17: Pipeline

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

  18. Slide 18: Pipeline (as of January 24, 2012): Filed/Approved

     Pipeline (as of January 24, 2012) Filed/Approved Stage Code name/ Category Other Indication Formulation In-house or licensed Remarks Product name Japan countries KW-0761 Filed Adult T-cell Mogamulizumab April 2011 Injection In-house POTELLIGENT® antibody* leukemia/lymphoma Oncology Chemotherapy Pe

  19. Slide 19: Pipeline (as of January 24, 2012): Phase II, Phase III

     Pipeline (as of January 24, 2012) Phase II, Phase III Code name/ Stage In-house or Category Indication Formulation licensed Remarks Product name Japan Other countries Phase I/II Peripheral T-cell lymphoma and in USA cutaneous T-cell lymphoma KW-0761 POTELLIGENT® Mogamulizumab Adult T-cell leukemia

  20. Slide 20: Pipeline: Phase II, Phase III continued

     Pipeline (as of January 24, 2012) Phase II, Phase III continued Stage Code name/ In-house or Category Other Indication Formulation licensed Remarks Product name Japan countries Phase ☆Pediatric Renal III Anemia KRN321 Nephrology Phase II Launched in Japan for anemia of Darbepoetin Injection Kirin-

  21. Slide 21: Pipeline (as of January 24, 2012): Phase I

     Pipeline (as of January 24, 2012) 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

  22. Slide 22: Pipeline: Phase I (continued) and withdrawal of application

     Pipeline (as of January 24, 2012) Phase I (continued) Stage Developed in- Code name/ Category Other Indication Formulation house or Remarks Product name Japan licensed countries RTA402 Licensed from Nephrology Bardoxolone Phase I Diabetic nephropathy Oral Reata Methyl Immunology/ KHK4827 Phase I P

  23. Slide 23: Antibody pharmaceutical pipeline

     Antibody pharmaceutical pipeline (as of January 24, 2012) Overview of Development Pipeline Therapeutic area Preclinical Ph I Ph II Filed KW-0761 (CCR4) ATL U.S. (Ph I/II) Japan (Ph II) Japan KRN330 (A33) ATL: Adult T-cell Leukemia-Lymphoma Eight U.S. (Ph I/II) Antibodies BIW-8962 (GM2) （five U.S.

  24. Slide 24: Licensing-out antibody pharmaceuticals

     Licensing-out antibody pharmaceuticals (as of Ｊａｎｕａｒｙ 24, 2012) Antibody Target Licensee Reported Stage Remarks Amgen (Allergy) 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

  25. Slide 25: POTELLIGENT technology-related alliances

     POTELLIGENT® technology-related alliances (as of Ｊａｎｕａｒｙ 24, 2012) Product branding alliances Joint development Out licensing Joint development POTELLIGENT® CHOK1SV Technology license (18 companies) Bristol-Myers Squibb Agensys CSL Limited ImmunoCellular Therapeutics, Ltd. *To date seven out-licen

  26. Slide 26: Progress with outlicensed compounds

     Progress with outlicensed compounds (as of Ｊａｎｕａｒｙ 24, 2012) 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 Asthma MedImmune (KHK4563:POTELLIGENT®) (Anti-IL-5R anti

  27. Slide 27: Progress with inlicensed compounds

     Progress with inlicensed compounds (as of January 24, 2012) Phase Name Partner Remarks I II III Parkinson’s disease KW-6500 Britannia Filed (Dopamine agonist) Emesis SP-01 Solasia Filed (Serotonin antagonist) Cancer pain KW-2246 Orexo (m-opioid receptor agonist) Lung cancer (c-met inhibitor) ARQ 1

  28. Slide 28: Biosimilar joint venture with Fujifilm

    Biosimilar joint venture with Fujifilm 27

  29. Slide 29: Biosimilar merger company: Overview

     Biosimilar merger company: Overview Provide an advanced Develop ground-breaking level of reliability and biopharmaceutical quality and superior cost- production technology competitive products leveraging synergies between both companies Joint venture company - To be established spring, 2012 (plann

  30. Slide 30: Leveraging technology developed by FUJIFILM

     Leveraging technology developed by FUJIFILM  In the short-term  Optimization of production process (culture, refinement, etc.) using by production and quality control technologies that allow precision control  Improve cell culture process leveraging analysis technology from photographic film di

  31. Slide 31: Business in Asia

    KYOWA KIRIN Business in Asia copyright© Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved ©

  32. Slide 32: Pharmaceutical business in Asia (End Dec 2011)

     Pharmaceutical business in Asia (End Dec 2011) Consolidated subsidiaries MRs Net sales Pharmaceutical businesses across Asia Products Korea ¥3.0 bn Est. May 1991 25 Nesp,Regpara,Renagel, Jeil-Kirin Pharmaceutical Gran, Busulfex, MitomycinC, Inc. Leunase China ¥2.8 bn Est. Jun. 1997 114 Espo,Gran,B

  33. Slide 33: Development and sales in Asian markets - 1

     Development and sales in Asian markets-1 ◎：Launched ○：Approved ☆：Filed As of December 31, 2011 Hong The Korea China Taiwan Singapore Thailand Malaysia Indonesia Vietnam India Kong Philippines Espo ◎ Phase Nesp ◎ Phase 2 ◎ ○ ☆ ◎ ○ ○ 3 Aranesp ◎ ◎ Renagel ◎ ◎ Gran ◎ ◎ ◎ ◎ ◎ ◎ ○ ◎ Peglasta ◎ ◎ ◎ ◎ ☆

  34. Slide 34: Development and sales in Asian markets - 2

     Development and sales in Asian markets-2 ◎：Launched ○：Approved ☆：Filed As of December 31, 2011 Hong The Korea China Taiwan Singapore Thailand Malaysia Indonesia Vietnam India Kong Philippines Ｍｉｔｏｍｙｃｉｎ Ｃ ◎ ◎ ◎ ◎ ◎ ◎ ◎ ◎ ◎ ◎ ◎ Ｌｅｕｎａｓｅ ◎ ◎ ◎ ◎ ◎ ◎ ◎ ◎ ◎ ◎ ◎ Ｃｏｎｉｅｌ ◎ ◎ ○ ◎ Ａｌｌｅｌｏｃｋ ◎ ◎ Ｓａｎｃｕｓｏ ☆ Phas

  35. Slide 35: 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 34

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