Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — Kyowa Hakko Kirin — FY2010 Interim Earnings Presentation

30 slides from Kyowa Kirin's earnings presentation, Jul 28, 2010

  1. Slide 1: Fiscal 2010 Interim Results

    Kyowa Kyowa Hakko Hakko Kirin Kirin Fiscal Fiscal 2010 2010 Interim Interim Results Results July 28, 2010 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 th

  2. Slide 2: Notice

    Notice The figures in this document for the 6-month period from January 1, 2009 to June 30, 2009 are the sum of the figures for the fourth quarter of the fiscal year ended March 31, 2009 (obtained by subtracting figures for the nine month period April 1, 2009 to December 31, 2009 from the figures fo

  3. Slide 3: Contents

    Contents Page >> Summary of fiscal 2010 interim results 3 >> Pipeline 16 >> KW-0761 update 24 >> Production of bio-pharmaceuticals 25 >> Tokyo Research Park 28 2

  4. Slide 4: Summary of fiscal 2010 interim results: P&L

     Summary of fiscal 2010 interim results: P&L Operating Recurring (¥bn) Net sales Net income income income FY2010 interim 203.4 21.6 22.3 9.9 +8.7 +7.9 +6.6 +2.9 Change (+4.5%) (+58.0%) (+42.3%) (+42.6%) FY2009 interim 194.7 13.7 15.6 6.9 3

  5. Slide 5: Pharmaceuticals business

     Pharmaceuticals business (¥bn) FY2009 interim FY2010 interim Change Net sales 101.3 103.4 +2.1 Operating income 16.7 17.9 +1.2 R&D expenses 18.3 19.3 +1.0 4

  6. Slide 6: Pharmaceuticals business: Change in sales

     Pharmaceuticals business: Change in sales (¥bn) Regpara +1.4 105.0 Nesp/Espo +1.3 Allelock - 1.3 + 1.1 - 1.5 Farmorubicin/Adriacin - 0.8 Coniel - 0.7 Patanol - 0.6 Navelbine - 0.5 Gran/Neu-up - 0.3 + 4.7 100.0 - 2.2 103.4 Lump sum from Amgen* +1.8 101.3 Export +1.1 Lump sum for KW-6002 +0.9 950 0.

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

     Pharmaceuticals business: Change in operating income (¥bn) 20.0 -0.2 - 1.0 + 2.4 17.9 16.7 150 0.0 Cost of sales June 2009 Gross profit R&D expense June 2010 (Excludes R&D) 6

  8. Slide 8: Bio-Chemicals and Chemicals businesses: Sales

     Bio-Chemicals and Chemicals businesses: Sales FY2009 FY2010 (¥bn) Change interim interim Sales 42.0 44.1 +2.1 Bio-Chemicals Operating income 2.1 1.8 -0.3 Sales 26.9 61.2 +34.3 Chemicals Operating income -5.6 1.5 +7.2 ¥/$ ¥95/$ ¥91/$ -¥4/$ Forex ¥/€ ¥127/€ ¥121/€ -¥6/€ Approx. Approx. Approx. Napht

  9. Slide 9: Bio-Chemicals businesses: Change in sales

     Bio-Chemicals businesses: Change in sales (¥bn) 45.0 Healthcare products +1.0 Daiichi Fine Chemical - 0.7 Transfer of livestock/fisheries products business - 0.4 Alcohol business - 0.4 + 3.5 44.1 - 1.4 42.0 400 0.0 Domestic Overseas June 2009 June 2010 sales sales 8

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

     Bio-Chemicals businesses: Change in operating income (¥bn) 2.5 + 0.1 2.0 - 0.5 2.1 + 0.1 1.8 0 Cost of sales June 2009 Gross profit R&D expense June 2010 (Excludes R&D) 9

  11. Slide 11: Chemicals businesses: Change in sales

     Chemicals businesses: Change in sales (¥bn) 60.0 Changes to subsidiaries’ segment classification +21.6 + 21.7 40.0 61.2 + 3.5 + 4.6 + 4.4 26.9 200 0.0 Raw materials Specialty Solvents Others / June 2009 for plasticizers chemicals June 2010 (non-consolidated) eliminations (non-consolidated) (non-co

  12. Slide 12: Chemicals businesses: Change in operating income

     Chemicals businesses: Change in operating income (¥bn) -1.6 + 0.1 1.5 0.0 +8.8 -5.6 -6.0 Cost of sales June 2009 Gross profit R&D expense June 2010 (Excludes R&D) 11

  13. Slide 13: Fiscal 2010 consolidated forecasts

     Fiscal 2010 consolidated forecasts Operating Recurring Net (¥bn) Net sales income income income 2010 (Jan.-Dec.) 407.0 37.5 39.0 20.0 (Compared to forecast announced +1.8% +4.2% +4.0% (--) Jan.29) 2010 (Jan.- Dec.) (Announced Jan. 29) 400.0 36.0 37.5 20.0 2009 (Jan. – Dec) 407.0 30.9 32.6 10.0 12

  14. Slide 14: Fiscal 2010 consolidated forecasts: Pharmaceuticals

     Fiscal 2010 consolidated forecasts: Pharmaceuticals (¥bn) 2009 Fiscal 2010 Change (Jan. - Dec.) Sales 207.3 205.0 -2.3 Operating income 31.8 29.0 -2.8 R&D expenses 41.6 42.1 +0.4 13

  15. Slide 15: Fiscal 2010 forecasts: Sales of core pharmaceutical products

     Fiscal 2010 forecasts: Sales of core pharmaceutical products Forecasts at 2009 Fiscal 2010 (¥bn) % change beginning of (Jan. - Dec) (forecast) term Nesp/Espo 48.9 48.3 1%↓ 49.7 Coniel 23.3 21.3 9%↓ 21.3 Allelock 26.7 26.0 3%↓ 26.0 Patanol 7.4 7.5 1%↑ 7.9 Gran/Neu-up* 17.0 15.1 11%↓ 15.1 Depakene 1

  16. Slide 16: Fiscal 2010 forecasts: Bio-Chemicals and Chemicals

     Fiscal 2010 forecasts: Bio-Chemicals and Chemicals (¥bn) 2009 Fiscal 2010 Change (Jan. – Dec.) (forecast Bio- Sales 90.6 84.0 -6.6 Chemicals Operating income 3.9 4.0 +0.0 Sales 64.2 128.0 +63.7 Chemicals Operating income -5.5 4.0 +9.5 ¥/$ ¥94/$ ¥91/$ ▲¥3/$ Forex ¥/€ ¥130/€ ¥116/€ ▲¥14/€ Approx. Ap

  17. Slide 17: R&D Pipeline: July 2010

     R&D Pipeline: July 2010 Kyowa Hakko Kirin (Phase II onwards) Code name/ Stage Category Product Indication Formulation In-house or licensed Remarks name Japan Other countries Humanized monoclonal antibody Phase I/IIa Cancer (The exclusive right to develop and commercialize for KW-0761 Phase II Inje

  18. Slide 18: R&D Pipeline: July 2010 (Phase I)

     R&D Pipeline: July 2010 Kyowa Hakko Kirin (Phase I) Stage Code name/ Developed in- Category Other Indication Formulation Remarks Product name Japan house or licensed countries KW-2450 Phase I Cancer Oral In-house Phase I/IIa in KW-2478 Cancer Injection In-house USA & Europe Phase I/IIa in Cancer/

  19. Slide 19: R&D Pipeline

     R&D Pipeline Kyowa Hakko Kirin (Phase I) (As of July 29, 2009) Code name/ Stage Developed in-house Category Product name Indication Formulation Remarks Japan Other countries or licensed Disseminated intravascular Phase I in Recombinant KW-3357 Phase I coagulation, Congenital Injection In-house Eur

  20. Slide 20: Antibody pharmaceutical pipeline

     Antibody pharmaceutical pipeline (as of July 2010) Overview of Development Pipeline Therapeutic Preclinical Ph I Ph II Area KW-0761 (CCR4) U.S. (Ph I/II) Japan (Ph II) KRN330 (A33) Cancer Ten Antibodies U.S. (Ph I/II) (eight BIW-8962 (GM2) POTELLIGENT® U.S. (Ph I/II) antibodies, ASKP1240 (CD40) fi

  21. Slide 21: Licensing-out antibody pharmaceuticals

     Licensing-out antibody pharmaceuticals (as of July 2010) 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 Pharmaceuti

  22. Slide 22: POTELLIGENT technology-related alliances

    POTELLIGENT® technology-related alliances (as of July 2010) Product branding alliances Joint development In licensing Out licensing Technology licensing Bristol-Myers Squibb CSL Limited *To date six out-licensed POTELLIGENT® antibodies have entered clinical trials, including those by Bristol-Myers

  23. Slide 23: Progress in licensing-out

     Progress in licensing-out (as of July 2010) Phase Name Partner Remarks I II III Parkinson’s disease Out-licensed in KW-6002 Biovail (adenosine A2A receptor North America antagonist) Tivozanib Cancer AVEO (KRN951) (VEGF receptor inhibitor) KW-2871 Cancer Life Science (Low-fucose antibody) (Anti-GD3

  24. Slide 24: Progress in licensing-in

     Progress in licensing-in (as of July 2010) Phase Name Partner Remarks I II III Hisamitsu Cancer pain HFT-290 Launched Pharmaceutical (-opioid receptor agonist) Cancer pain KW-2246 Orexo Filed (-opioid receptor agonist) Vomit SP-01 Solasia Pre-filing preparations (Serotonin antagonist) Parkinson’

  25. Slide 25: KW-0761 Update

     KW-0761 Update KW-0761  An anti-CCR-4 antibody that uses our in-house developed POTELLIGENT® technology (enhanced activity antibody manufacturing technology)  Kyowa Kirin is conducting clinical trials for hematological cancer applications in Japan and the U.S  Amgen is conducting clinical trial

  26. Slide 26: Strength in manufacturing: Key to success in antibody pharmaceuticals

     Strength in manufacturing: Key to success in antibody pharmaceuticals World-class quality ・ Applying Espo, Nesp biotechnologies (e.g. Serum-free cell culture system technology) to antibody pharmaceuticals Quality ・ Manufacturing and quality assurance system compliant with tri-polar regulations* Ra

  27. Slide 27: Strength in manufacturing: Key to success in antibody pharmaceuticals

     Strength in manufacturing: Key to success in antibody pharmaceuticals Bio process research and development laboratories Takasaki factory Accelerating the process from research to manufacturing Aerial view of Takasaki Factory / Bio 高崎工場・バイオ生産技術研究所 航空写真production technology research facility 26

  28. Slide 28: Strength in manufacturing: Creating a production platform

     Strength in manufacturing: Key to success in antibody pharmaceuticals Creating an antibody pharmaceutical production platform Complex Prognosis, analysis Vulnerable ・Master cell bank Long production period molecules difficulties molecules Market Research Development launch Time/ Manufacturing Actu

  29. Slide 29: Tokyo Research Park

     Tokyo Research Park Name: Tokyo Research Park, New Research Center (Machida City, Tokyo) Scale: Reinforced concrete, three floors above ground, one below Height: 22.6m Total floor space: About 19,000m2 Usage: A research facility designed to support the planning and pursuit of new research directio

  30. Slide 30: 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 29

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