Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — FY2010 Earnings Presentation
39 slides from Kyowa Kirin's earnings presentation, Jan 28, 2011
Slide 1: Fiscal 2010 Results
Kyowa Kyowa Hakko Hakko Kirin Kirin Fiscal Fiscal 2010 2010 Results Results (Fiscal (Fiscalyear yearto toDecember December31, 31,2010) 2010) January 28, 2011 President & CEO Yuzuru Matsuda Kyowa Hakko Kirin Co., Ltd Statements on results, forecasts and R&D status contained in this presentation repre
Slide 2: Note on fiscal period change
Note: The fiscal period ended December 31, 2009 was a nine-month reporting period due the change in fiscal year-end from March 31 to December 31. As a result, figures in this presentation for the 12-month period ended December 31, 2009 are derived by subtracting figures for the April to December (9-
Slide 3: Contents
Contents Page >> Summary of fiscal 2010 results 3 >> R&D Pipeline 17 >> KW-0761 Update 26 >> Changes to the Tokyo Research Park Structure 31 >> FDA warning letter to Kyowa Hakko Bio facilities in Yamaguchi(Hofu) 32 >> Items related to transfer of all Kyowa Hakko 33 Chemical shares >> Vertical divers
Slide 4: Summary of fiscal 2010 results: P&L
Summary of fiscal 2010 results: P&L Operating Recurring (¥bn) Net sales Net income income income FY2010 413.7 45.4 46.5 22.1 +6.7 +14.4 +13.8 +12.1 Change (+1.7%) (+46.8%) (+42.5%) (+121.1%) FY2009 407.0 30.9 32.6 10.0 3
Slide 5: Summary of fiscal 2010 results: Pharmaceuticals business
Summary of fiscal 2010 results: Pharmaceuticals business (¥bn) FY2009 FY2010 Change Net sales 207.3 210.3 +2.9 Operating income 31.8 35.8 +4.0 R&D expenses 41.6 40.0 -1.6 4
Slide 6: Pharmaceuticals business: Increase (decrease) in net sales
Pharmaceuticals business: Increase (decrease) in net sales (¥bn) 2,200 220 Nesp/Espo +3.7 Regpara +2.7 + Permax +2.0 Gran/Neu-up -2.6 Coniel -2.3 Farmorubicin / Adriacin -1.6 Navelbine -0.9 ++12 Coversyl -0.6 + 1.2 Celtect -0.6 - - 35 3.5 5-FU -0.6 210 2,100 +61 + 6.1 -- 0.8 8 210.3 2,103 One-off
Slide 7: Pharmaceuticals business: Increase (decrease) in operating income
Pharmaceuticals business: Increase (decrease) in operating income (¥bn) 35 350 +16 + 1.6 -- 0.7 7 ++30 3.0 358 35.8 31.8 318 300 0 SG&A R&D FY 2009 Gross sales (excludes R&D FY 2010 expenses) expenses 6
Slide 8: Summary of fiscal 2010 results: Bio-Chemicals and Chemicals businesses
Summary of fiscal 2010 results: Bio -Chemicals and Chemicals businesses (¥bn) FY 2009 FY 2010 Change Net sales 90.6 84.2 -6.4 Bio- Chemicals Operating 3.9 3.2 -0.6 income Net sales 64.2 130.0 +65.8 Chemicals Operating -5.5 5.6 +11.2 income ¥/$ ¥94/$ ¥88/$ -¥6/$ Forex ¥/€ ¥130/€ ¥116/€ -¥14/€ Appro
Slide 9: Bio-Chemicals business: Increase (decrease) in net sales
Bio-Chemicals business: Increase (decrease) in net sales (¥bn) Health care products +1.4 Pharmaceuticals / Industrial raw materials +1.0 Alcohol business - 2.7 Impact from change of year-end in FY2009* -5.0 Products for the livestock and fisheries -1.4 Forex -2.4 Other -1.3 Sales volumes, etc. +4.
Slide 10: Bio-Chemicals business: Increase (decrease) in operating income
Bio-Chemicals business: Increase (decrease) in operating income (¥bn) Business restructuring -1.1 40 4 Forex -1.1 Sales volumes, etc. + 0.7 -- 15 1.5 ++1 0.1 3 30 39 3.9 ++7 0.7 32 3.2 20 0 Gross SG&A R&D FY 2009 sales (excludes R&D FY 2010 expenses) expenses 9
Slide 11: Chemicals business: Increase (decrease) in net sales
Chemicals business: Increase (decrease) in net sales (¥bn) 1,500 150 Changes to subsidiary segments +44.3 ++450 45.0 100 1,000 1,300 130 ++67 6.7 ++79 7.9 ++62 6.2 64.2 642 500 0 Raw Specialty Solvents materials for chemicals Other / 2009/12 (non-consolidated) plasticizers eliminations 2010/12 (non
Slide 12: Chemicals business: Increase (decrease) in operating income
Chemicals business: Increase (decrease) in operating income (¥bn) -2.9 6.0 60 +1 +0.1 +14.1 56 5.6 0 ▲-55 -5.5 -60 -0.6 Gross SG&A R&D FY 2009 (excludes R&D expenses FY 2010 sales expenses) 11
Slide 13: Fiscal 2011 full year forecasts
Fiscal 2011 full year forecasts Operating Recurring (¥bn) Net sales Net income income income FY 2011 325.0 37.0 38.0 25.5 Change (-21.4%) (-18.5%) (-18.3%) (+14.9%) FY 2010 413.7 45.4 46.5 22.1 12
Slide 14: Fiscal 2011 full year forecasts: Pharmaceuticals
Fiscal 2011 full year forecasts: Pharmaceuticals (¥bn) FY 2010 FY 2011 Change Net sales 210.3 212.0 +1.6 Operating income 35.8 32.0 -3.8 R&D expenses 40.0 46.5 +6.4 13
Slide 15: Fiscal 2011 forecasts: Sales of core pharmaceutical products
Fiscal 2011 full year forecasts: Sales of core pharmaceutical products (¥bn) FY 2010 FY 2011 Change Nesp 41.7 46.9 12%↑ Espo 10.8 4.0 63%↓ Nesp/Espo 52.6 50.9 3%↓ Regpara 9.5 11.1 17%↑ Allelock 26.8 29.8 11%↑ Patanol 7.5 10.2 36%↑ Gran/Neu-up 14.4 14.5 1%↑ Fentos 0.8 2.4 200%↑ Coniel 21.0 19.9 5%↓
Slide 16: Fiscal 2011 forecasts: Bio-Chemicals and Chemicals businesses
Fiscal 2011 full year forecasts: Chemicals Bio-Chemicals and businesses (¥bn) FY 2010 FY 2011 Change Net sales 84.2 80.0 -4.2 Bio- Chemicals Operating 3.2 3.0 -0.2 income Net sales 130.0 31.0 -99.0 Chemicals Operating 5.6 1.5 -4.1 income ¥/$ ¥88/$ ¥85/$ -¥3/$ Forex ¥/€ ¥116/€ ¥110/€ -¥6/€ Approx.
Slide 17: Fiscal 2011 forecasts: Relative to medium-term plan
Fiscal 2011 full year forecasts: Relative to medium-term plan Medium-term Current FY2011 (¥bn) plan forecast Difference Sales 215.0 212.0 -3.0 Pharmaceuticals OP 30.9 32.0 +1.1 R&D expense 44.5 46.5 +2.0 Sales 84.0 80.0 -4.0 Bio-Chemicals OP 5.8 3.0 -2.8 Sales 135.0 31.0 -104.0 Chemicals OP 4.0 1.
Slide 18: R&D Pipeline: October 2010
R&D Pipeline: October 2010 Kyowa Hakko Kirin (Phase II onwards) (As of January 28, 2011) Code name/ Stage Category Product Indication Formulation In-house or licensed Remarks name Japan Other countries Cancer POTELLIGENT antibody Phase II (Adult T-cell leukemia/lymphoma) *KW-0761 was outlicensed t
Slide 19: R&D Pipeline: October 2010
R&D Pipeline: October 2010 Kyowa Hakko Kirin (Phase II onwards) (As of January 28, 2011) Stage Code name/ Category Indication Formulation In-house or licensed Remarks Product name Japan Other countries Licensed-out Entered into a license agreement KW-6002 Phase III in US in Parkinson's disease Ora
Slide 20: R&D Pipeline: October 2010 (Phase I)
R&D Pipeline: October 2010 Kyowa Hakko Kirin (Phase I) (As of January 28, 2011) Stage Code name/ Developed in- Category Other Indication Formulation Remarks Product name Japan house or licensed countries Phase I/IIa KW-2450 Cancer Oral In-house in USA Phase I/IIa KRN330 Cancer Injection In-house i
Slide 21: R&D Pipeline: October 2010 (Phase I)
R&D Pipeline: October 2010 Kyowa Hakko Kirin (Phase I) (As of January 28, 2011) Code name/ Stage Developed in-house Category Product name Indication Formulation Remarks Japan Other countries or licensed KHK6188 Phase I Neuropathic pain Oral In-house KW-3357 Disseminated intravascular Phase I in Ph
Slide 22: AMG827 mechanisms
AMG827 mechanisms • Fully human IgG2 IL-17A/F IL-17A/F IL-17F IL-25 anti–IL-17RA1 mAb IL-17A Anti–IL-17RA antibody • Binds the human IL-17RA1 subtype with high affinity • Prevents IL-17A, IL-17F, IL-17A/F, IL-17RC IL-17RA IL-17RB IL-17RA IL-17RC IL-17RA and IL-25 signaling IL-17RB IL-17RA 1) IL-17
Slide 23: Antibody pharmaceutical pipeline (as of January 2011)
Antibody pharmaceutical pipeline (as ( of January 2011) Overview of Development Pipeline Therapeutic Preclinical Ph I Ph II Area KW-0761(CCR4) U.S. (Ph I/II) Japan (Ph II) KRN330(A33) Ten Antibodies U.S. (Ph I/II) Oncology (seven BIW-8962(GM2) POTELLIGENT® U.S. (Ph I/II) antibodies, KHK2866 five K
Slide 24: POTELLIGENT technology related alliances
POTELLIGENT® technology related alliances (as of January 2011) Product Licenses Joint R&D Out-license Joint R&D POTELLIGENT® CHOK1SV Technology Licenses Bristol-Myers Squibb Agensys CSL Limited *Including POTELLIGENT contracts with Bristol-Myers Squibb and Genentech, six antibodies have entered cli
Slide 25: Progress in licensed out compounds
Progress in licensed out compounds (as of January 2011) Phase Name Partner Remarks I II III Parkinson's disease KW-6002 Biovail Out-licensed in USA (adenosine A2A receptor antagonist) Tivozanib Malignant tumor AVEO (KRN951) (VEGF receptor inhibitor) KW-2871 Malignant tumor Life Science (Low-fucose
Slide 26: Progress in licensed in compounds
Progress in licensed in compounds (as of January 2011) Phase Name Partner Remarks I II III Cancer pain HFT-290 Hisamitsu Product has been launched (-opioid receptor agonist) Vomiting SP-01 Solasia Preparing to be filed (Serotonin antagonist) Cancer pain KW-2246 Orexo (-opioid receptor agonist) P
Slide 27: KW-0761 Phase 2 Study in Japan
KW-0761 Phase 2 Study in Japan Target disease Relapsed subjects with CCR4-positive adult T-cell leukemia-lymphoma Study objectives To evaluate the efficacy, safety and pharmacokinetic profiles of KW-0761 Doses and schedules KW-0761 is administered weekly for 8 weeks as an intravenous infusion at a
Slide 28: KW-0761 Phase 2 Study in Japan: Ex. A Hematological CR
KW-0761 Phase 2 Study in Japan : EX. A (cells/μL) 10000 1.0mg/kg KW-0761 8000 Hematological CR 6000 Neutrophil 4000 2000 Lymphocytes (including abnormal T-cells） ATL cells 0 0 14 28 42 56 70 Time (days) Dr. Ishida Takashi presented in the 52nd American Society of Hematology annual meeting 27
Slide 29: KW-0761 Phase 1/2 Study in US
KW-0761 Phase 1/2 Study in US Target disease Subjects with previously treated peripheral T-cell lymphoma or cutaneous T-cell lymphoma Study objectives To evaluate the efficacy, safety, pharmacokinetic profiles and recommended phase 2 part dose of KW-0761 Doses and schedules Phase 1 part: 0.1, 0.3
Slide 30: Changes to the Tokyo Research Park structure
Changes to the Tokyo Research Park structure Improper management of recombinant mouse: At Tokyo Research Park, on August 4, and August 11 of 2010, it came to light that the actual number of recombinant mice bred and the number of mice accounted for, differed by two Cause: Inadequate record kee
Slide 31: FDA warning letter to Kyowa Hakko Bio facilities in Yamaguchi (Hofu)
FDA warning letter to Kyowa Hakko Bio facilities in Yamaguchi(Hofu) Events: On September 29, 2010, FDA submitted a warning letter to Kyowa Hakko Bio facilities in Yamaguchi(Hofu) Contents of warning letter: Identified 9 problem points regarding quality control Response: With advice from a US
Slide 32: Items related to transfer of all Kyowa Hakko Chemical shares
Items related to transfer of all Kyowa Hakko Chemical shares Reasons for share transfer: For Kyowa Hakko Kirin Group to focus management resources on drugs for pharmaceutical use and related areas For Kyowa Hakko Chemical to develop its business as a global niche player and to be able to activ
Slide 33: Application of Kyowa Hakko Chemical share transfer proceeds
Application of Kyowa Hakko Chemical share transfer value 2015 Transfer of all Kyowa Hakko Chemical shares Build Contribution from US sales Proceeds POTELLIGENT business network Pipeline abundant with antibodies and low Rush of Rush Active molecular weight products mainly for cancer, applications o
Slide 34: Pharmaceuticals Business: Current and future assets
Pharmaceuticals Business: Current and future assets (in pipeline): USA Japan/Asia Pipeline Europe Existing products KW-0761 ASKP1240 Existing products Nesp (Aranesp) Espo KW-2450 KRN330 Mitomycin Allelock, Coniel, Gran, Regpara, etc. BIW-8962 KW-2478 KHK2866 KRN23 Pipeline Pipeline KW-2478 KW-3357
Slide 35: Vertical Diversification
Vertical Diversification Fermentation of Amino Acids and Biologically Active Agents APIs, Pharmaceutical Intermediates Use for Infusion, culture media Consumer Biosimilars Animal Drugs Vaccines Generics Biologics, Therapeutic Medicinal Diagnostics Antibodies chemicals Food Supplements (mail-order) K
Slide 36: Bio-Chemicals business: Current status and potential (1)
Bio-Chemicals business: Current status and potential (1) Amino acid business: High value added products primarily in pharmaceuticals and for pharmaceutical use Current status: Record level manufacturing and sales volumes, revenues down due to effects form foreign exchange Potential: Growing de
Slide 37: Bio-Chemicals business: Trends in the amino acid market
Bio-Chemicals business: Current status and potential (2) - Trends in the amino acid market - 2020 (forecast) Amino acid demand (global estimates) KHB sales volumes 38 thousand tons KHB: Kyowa Hakko Bio Co., Ltd. 2010 (100% subsidiary of KHK) 2000 26 thousand tons 17 thousand tons KHB share: over 5
Slide 38: Bio-Chemicals business: Current status and potential (3)
Bio-Chemicals business: Current status and potential (3) Health care business Current status: Strong, partly due to the effects of “Plus-i”, Kirin Group’s food and health project In particular, strong growth in sales from health food mail-order business (1.5 fold increase y-on-y, now more than
Slide 39: Inquiries
If you have any inquiries regarding this presentation please call: Corporate Communications Department, Kyowa Hakko Kirin Co., Ltd Tel: 03-3282-0009 38