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Kyowa Hakko Kirin Co ., Ltd Fiscal 2008 First Half Results

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Kyowa Hakko Kirin Co ., Ltd Fiscal 2008 First Half Results Kyowa Hakko Kirin Co ., Ltd Fiscal 2008 First Half Results October 30, 2008 President and Chief Executive Officer Yuzuru Matsuda Statements on results, forecasts and R&D status contained in this presentation represent judgments based on information available at the current time. Actual results may differ significantly due to a variety of factors such as economic conditions and exchange rate fluctuations. Separate service 65% 1 companies HD: Kirin by Other businesses Held by Kirin HD: Held by Kyowa Kirin: 35% subsidiary of Kirin Holdings Business integration 2011.1.1owned wholly a Will become 2009.4.1 Kirin Kyowa Foods Launched Kirin Food-Tech Other subsidiaries KYOWA HAKKO FOOD SPECIALTIES Kirin Co., Ltd. Kyowa Hakko Kirin Holdings KYOWA HAKKO CHEMICAL Mercian KYOWA HAKKO BIO Kirin Beverage Kirin Brewery Business structure (200810.1 ~) z z Outline of Fiscal 2008 firstfirst halfhalf rresultsesults Operating Recurring (¥bn) Net sales Net income income income FY08 H1 247.7 29.1 30.3 8.2 +55.1 +10.9 +12.2 -2.7 Change (+28.6%) (+59.8%) (+67.9%) (-25. 0%) FY07 H1 192.6 18.2 18.0 11.0 z Pharmaceuticals Sales and profits up due to Kirin Pharma integration, receipt of oneone--offoff payment from Amgen, etc. z Bio-Chemicals Sales and profits up due to growth in amino acids for intravenous liquids and pharmaceutical raw materials, and increased sales of health care products z Chemicals Sales up due to price revisions following rapid rise in fuel and raw materials prices but increased depreciation expense contributed to lower operating income z Food Sales and profits declined slightly affected by high raw material prices z Corporate tax Adjustment of ¥¥5.65.6 billion resulting from recognition of tax on planned sale of Kyowa Hakko Food Specialties z Extraordinary loss Resulting from integration-integration-relatedrelated expenses, including impairment losses on integration of R&D facilities 2 z Segmental sales changes: Fiscal 2008 interim Sales breakdown Pharmaceuticals: + ¥39.8bn Bio-Chemicals: + ¥1.9bn September 2007 1,100 465 12% 1,000 450 10% 33% 900 435 800 420 700 405 24% 600 390 21% 500 375 Pharmaceu tica ls Bio- Chem ica ls Chemicals Food Other 400 360 300 345 2007/9 2008/9 2007/9 2008/9 September 2008 14% Chem ica ls: + ¥61b6.1bn Food: - ¥01bn0.1 bn 580 210 8% 40% 560 208 540 206 520 204 500 202 21% 480 200 460 198 17% 440 196 Pharmaceuticals Bio-Chemicals 420 194 Chemicals Food Other 400 192 380 190 2007/9 2008/9 2007/9 2008/9 z Pharmaceuticals sales increased driven by integration with Kirin Pharma in addition to a oneone--timetime payment from Amgen, the launch of Coversyl, and continued growth in Patanol z BioBio--ChemicalsChemicals saw strong sales of amino acids for intrintravenousavenous liquids and pharmaceutical raw materials btbut was a fftdbfffected by forei gn exch ange movemen ts. H ea lth care pro duc ts s howe d con tinue d grow th z Chemical product price rises were implemented in response to a higher indicated price for naphtha from ¥¥58,750/kl58,750/kl in fiscal 07 H1 to around ¥¥78,000/kl78,000/kl in fiscal 08 H1 z Segmental operating income changes: Fiscal 2008 interim Operating income breakdown Pharmaceuticals: + ¥9.9bn Bio-Chemicals: + ¥1.1bn September 2007 53 200 50 180 47 2% 160 4% 44 140 18% 41 54% 120 22% 38 100 35 80 32 60 29 Pharmaceuticals Bio-Chemicals Chemicals 40 26 Food Other 20 23 0 20 2007/9 2008/9 2007/9 2008/9 September 2008 Food: - ¥01bn0.1 bn 2% 2% Chem ica ls: - ¥03b0.3bn 10% 33 7 18% 30 6 27 24 5 21 68% 18 4 15 3 12 Pharmaceuticals Bio-Chemicals Chemicals Food 9 2 Other 6 1 3 0 0 2007/9 2008/9 2007/9 2008/9 Higher profits in Pharmaceuticals and BioBio--ChemicalsChemicals z Chemical product prices were raised against a background of higher raw material and fuel prices, but profits declined as capex resulted in higher depreciation expenses z Pharmaceuticals (Comparison of simple sum of both company’s FY07 and FY08 results) FY 2007 Interim FY 2008 (¥bn) (Sum of two Change Interim companies) Net sales 103.5 108.7 +5.1 Operating income 16.1 24.0 +7.9 R&D expenses 24.8 23.0 -1.8 *Figures for FY 2008 Interim operating income is based on before amortization of goodwill related to the integration Higher sales and profits z Factors benefiting net sales and operating income included a one-time payment from the out-licensing of KWKW--0761*to0761*to Amgen , the ｌａｕｎｃｈ of Coversyl (April 2008) and REGPARA (January 2008), and continued growth in Patanol z Factors decreasing net sales and operating income included price revisions and the termination of Durotep sales z Sales of NESP/ESPO decreased from the effects of price revisions despite an increase in market share compared to FY07 H1 z FY08 interim R&D e xpenses were lo wer than the net total of the tw o companies for FY07 H1 Note: KWKW--07610761 is an antibody drug developed by Kyowa Hakko Kirin that utilizes our original strong-strong-actingacting antibody 5 ® technology (POTELLIGENT ) z Sales of core pharmaceutical products Reference: Reference: Full year Full year (¥ bn) 2007/9 2008/9 forecast forecast (As of July 31) (Revised) NESP/ESPO 22. 5 21.3 46.8 43.0 Coniel 13.2 11.6 22.8 22.9 Alle loc k 959.5 9.6 23.3 23.1 Patanol 0.8 1.4 5.0 4.9 Gran/Neu-up* 959.5 9.1 18.2 18.3 Depakene 5.2 5.3 10.3 10.7 Navelbine 161.6 1.5 3.3 3.1 Durotep 7.1 －－－ Coversyl － 2.6 4.3 5.0 REGPARA － 1.9 6.9 4.2 Export and technology out- licensing revenues(*) 11. 6 22.8 29.5 29.7 Note: FY07/9 figures for Gran/Neu-up and for export and technology out-licensing revenues are the simple sum of figures for the two companies 6 z BioBio--ChemicalsChemicals (¥bn) FY06 H1 FY07 H1 FY08 H1 Change from FY07 H1 Net sales 33. 3 43. 8 45. 7 +1. 9 Operating 1.5 4.0 5.2 +1.1 income Sales a nd p ro fits up due to g ro wt h in aaoacdsomino acids for intra ve n ous an d con tin ued growth in sales of health care products z In industrial and pharmaceutical raw materials sales, sales of amino acids for intravenous liquids supported by increased overseas demand were strong z Health care products saw increased revenues as sales of health food ingredients in the US and domestic mail order products were strong z Da iic hi Fine Chem ica l’s sa les o f v itam ins decrease d as a resu lt o f fierce compe tition 7 z Fiscal 2008 fullfull--yearyear forecasts (consolidated) Operating Recurring (¥bn) Net sales Net income income income FY 2008 forecast 490. 0 50. 0 50. 0 17. 0 (Compared to forecast （ ） ） announced April 2008） -- (-12.3% (-10.7%) (-39.3%) FY 2008 forecast 490. 0 57. 0 56. 0 28. 0 (announced April 2008) FY 2007 actual 392.1 39.3 37.9 23.4 PfitfProfit forecas ts rev iddised down d ue t o a revi ew of ff forecast tfs for renal area prod uct s and di increased expenses arising from active inin--licensinglicensing z InIn--licensedlicensed joint development rights for an antantibodyibody drug candidate, and RNAi pharmaceutical product (not included in forecast announced April 2008) z AidjilihHFTAcquired joint sales rights to HFT-290 (cancer pa in treatment ) from Hisam itsu Pharmaceut ica ls (not inc lu de d in forecast announced April 2008 ) z NESP/ESPO, REGPARA – Reduced sales forecasts z In the Bio-Chemicals segment sales of amino acids for industrindustrialial and pharmaceutical raw materials remained strong but severe price competition in vitamins are expected to result in only a small increase in profits compared to forecastforecast z In chemical products, carefully monitoring raw material prices will be continued ((¥¥70,000/kl70,000/kl naphtha price assumed for second half of fiscal year） z Extraordinary profits/losses: Expect to realize profit on sale of food business, but integration related expenses expected to increase 8 Pharmaceuticals 9 z R&D pipeline (As of October 2008) Kyowa Hakko Kirin As of October 30, 2008 Code Name Stage In-house Category Indication FormulationOR Remarks Product Name Japan Other countries Licensed ☆ Long-acting erythropoiesis stimulating protein. Anemia KRN321 NESP Phase III Injection Kirin-Amgen Sales for anemia of CKD patients on dialysis were (After chemotherapy for cancer) launched in Japan in July 2007. Thrombocytopenia treatment Thrombopoiesis stimulating peptibody. The clinical AMG531 Phase III (Ideopathic thrombocytopenic Injection Kirin-Amgen development is being conducted by Amgen purpura) development KK under contract. Sublingual KW-2246 Phase II Cancer pain Orexo tablet KRN125 Phase II Neutropenia Injection Kirin-Amgen Long-acting G-CSF Phase II in AGS-003 Canada and Renal Cell Carcinomia Injection Argos USA Phase II in Immunity activation agent AGS-004 Injection Argos Canada (HIV cell therapy) Cancer KRN654 Phase I/II Essential thrombocythemia Injection Shire Humanized monoclonal antibody (The exclusive right Anticancer Developed to develop and commericalize for treatments other KW-0761 Phase I Injection (Hematologic tumor) In-house than cancer, and except in Japan, Korea, China and Ta iwan, was trans ferre d to Amgen in Marc h 2008) Developed KW-2449 Phase I in USA Anticancer Oral In-house Phase I in Developed KW-2478 Anticancer Injection Europe In-house ARQ197 Phase I Anticancer Oral ArQule Developed KRN330 Phase I in USA Anticancer Injection Fully human monoclonal antibody In-house Updated since April 28th, 2008 (Area, Stage, Filed, Approved, Launched etc.) Notes: In Vietnam, an NDA of Pegfilgrastim (long acting G-CSF) has been filed for neutropenia and, 10 in the Philippines, an NDA of Filgrastim (G-CSF) has been filed for neutropenia.
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