Kyowa hakko kirin_fy2011_6months_presentation

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  • 1. Kyowa Hakko Kirin Kyowa Hakko Kirin Fiscal 2011 Interim Results Fiscal 2011 Interim Results (January 11-June 30, 2011) (January - June 30, 2011) President & CEO Yuzuru Matsuda August 2, 2011 Kyowa Hakko Kirin Co., LtdStatements 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.
  • 2. Contents Page>> Summary of interim results 2>> Outline of ProStrakan, accounting treatment 10>> Full year forecasts 14>> Pipeline 19 1
  • 3. Summary of interim results 2
  • 4.  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 not included in the above figures. 3
  • 5.  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.  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 licensing Overseas sales eliminations interim (Non-consolidated) sales (Non-consolidated) sales 5
  • 7.  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.  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 segment is included in consolidation for the January-March period of fiscal 2011 and excluded from April 2011. 7
  • 9.  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.  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. Outline of ProStrakan, accounting treatment 10
  • 12.  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.  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 Committee  Europe strategy ●KHK UK  Organically combine the European sales infrastructure of ProStrakan and KHK ●KHK Italia  Assess cross-selling opportunities for KHK’s core European anticancer treatment Mitomycin-C and pursue other synergies  U.S. strategy U.S. sales force of approx. 50  Focus on establishing the presence of Sancuso and Abstral in the U.S. market  Sales of KW-0761 and other new products 12
  • 14.  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 131.2 1. Amortization period differs for each asset, 4.5 to19.5 years (straight line method) Intangible assets 182.3 Deferred tax liabilities 37.9 2. 15 years by straight Acquisition cost 287.1 line method Goodwill 217.8 To be amortized Expected effects on profits from corporate merger accounting treatment: 1. Intangible assets amortization: 2011 H2 GBP9.0m (Ref: 2012 full year GBP18.1m) 2. Goodwill amortization: 2011 H2 GBP7.3m (Ref: 2012 full year GBP14.5m) Total amortization: 2011 H2 GBP16.3m (Ref: 2012 full year GBP32.6m) 13
  • 15. 2011 forecasts 14
  • 16.  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 413.7 45.4 46.5 22.1 *ProStrakan figures consolidated based on an assumed acquisition date of June 30, 2011. 15
  • 17.  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 Total effect = -2.6 Inventory revaluation: -0.6 Intangibles amortization: -1.2 Operating 35.8 37.5 +1.6 32.0 +5.5 Goodwill amortization: -0.9 income Note: Forecast FY2011 H2 operating income for ProStrakan alone = - ¥0bn R&D 40.0 45.0 +5.0 46.5 -1.5 +0.6 expenses 16
  • 18.  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 1%↑ 14.5 Fentos 0.8 2.6 225%↑ 2.4 Coniel 21.0 19.7 6%↓ 19.9 Coversyl 4.2 3.9 7%↓ 3.9 Depakene 11.0 11.1 1%↑ 11.0 Permax 2.0 2.3 15%↑ 2.3 Asacol 0.7 2.8 300%↑ 2.6 Exports and technology 24.1 22.4 7%↓ 23.9 out-licensing revenues *Sales of Neu-up were transferred to Yakult Honsha as of March 2010 *Sales of Fentos began in June 2010 *Sales of Permax were transferred from Eli Lilly as of April 2010 17
  • 19.  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. Pipeline 19
  • 21.  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 Injection Kirin-Amgen Launched for anemia of CKD patients Oncology Nov/2008 induced anemia Alfa Pegfilgrastim Filed in Neutropenia Injection Kirin-Amgen Asia: Korea, Taiwan and Vietnam Asia Launched in Japan for secondary Cinacalcet Filed in Secondary Oral NPS hyperparathyroidism Hydrochloride Singapore hyperparathyroidism Nephrology Darbepoetin Anemia Approved in Thailand on May 25 Approved injection Kirin-Amgen in Asia (on dialysis) (Asia: Filed in Singapore and the Alfa Philippines) KW-6500 Filed CNS Licensed from Apomorphine Parkinsons disease Injection July 2011 Britannia Pharma. Hydrochloride Immune Approved in Korea on June 1 AMG531 Launched Approved (Asia: Filed in Singapore, Hong Kong, Other thrombocytopenic Injection Kirin-Amgen Malaysia and Taiwan) Romiplostim April 2011 in Asia purpura *KW-0761 was outlicensed to Amgen Inc. in March, 2008, with an exclusive right to develop and commercialize KW-0761 worldwide, except in Japan, Korea, China and Taiwan. However, in 2010, Kyowa Hakko Kirin repurchased the development and commercialization rights held by Amgen for overseas markets in cancer-related areas. Kyowa Hakko Kirin now holds the development and commercialization rights worldwide for cancer-related areas. Updated since January 28, 2011 ( Area, Stage, Filed, Approved, Launched etc.) 20
  • 22.  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 lymphoma) March, 2008, with an exclusive right to develop and commercialize KW-0761 worldwide, except Adult T-cell in Japan, Korea, China and Taiwan. However, in KW-0761 Phase II leukemia/lymphoma, Injection In-house 2010, Kyowa Hakko Kirin repurchased the Add-on therapy development and commercialization rights held by Amgen for overseas markets in cancer- (Peripheral T/NK-cell related areas. Kyowa Hakko Kirin now holds the Phase II Lymphoma) development and commercialization rights worldwide for cancer-related areas. KW-2246 Cancer pain Sublingual Licensed Oncology Fentanyl Phase III tablet from Orexo citrate KRN125 Phase III Neutropenia Injection Kirin-Amgen Pegfilgrastim Phase II in Cancer Phase II Korea (Gastric cancer) ARQ 197 Oral Licensed from ArQule. Phase I Lung cancer Phase I/II KW-2478 In UK, USA, Multiple myeloma Injection In-house Philippines Updated since January 28, 2011 ( Area, Stage, Filed, Approved, Launched etc.) 21
  • 23.  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 Alfa Phase II Anemia Nephrology in China (on dialysis) Cinacalcet Phase III Secondary in China Oral Licensed from Japan: Already launched Hydrochloride hyperparathyroidism NPS Phase II Organ Transplant ASKP1240 Phase I in USA Injection In-house Developed with Astellas Rejection Immunology/ Allergy Oral (pH dependent Jointly developed with Zeria Z-206 Licensed from Pharma Phase II ★ Crohns disease controlled- Mesalazine Zeria Pharma. Already launched in Japan for release ulcerative colitis formulation) North America rights outlicensed to KW-6002 Valeant Pharmaceuticals Phase III Parkinsons disease Oral In-house Istradefylline International have been restored to Kyowa Kirin CNS Licensed from KW-6485 Janssen Launched as an epilepsy treatment Phase III ★ Pediatric epilepsy Oral in Japan Topiramate Pharmaceuticals KK Disseminated KW-3357 Phase I in intravascular Other Phase III Injection In-house Antithrombin Europe coagulation, Congenital antithrombin deficiency Updated since January 28, 2011 ( Area, Stage, Filed, Approved, Launched etc.) ★ Expanded application 22
  • 24.  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 Injection In-house POTELLIGENT ® antibody in USA Oncology KRN951 Phase I Cancer Oral In-house Tivozanib Phase I KHK2866 Cancer Injection In-house POTELLIGENT ® antibody in USA LY2523355 Being developed by Eli Lilly Phase I Cancer Injection In-house Litronesib outside Japan RTA402 Licensed from Nephrology Bardoxolone Phase I Diabetic nephropathy Oral Reata Methyl Potelligent antibody Immunology/ KHK4563 Being developed by Phase I Asthma Injection In-house MedImmune as MEDI-563 Allergy Benralizumab worldwide except in Japan and other Asian countries KHK6188 Phase I Neuropathy Oral In-house Other Phase I Hypophosphatemic KRN23 Injection In-house in USA rickets Updated since January 28, 2011 ( Area, Stage, Filed, Approved, Launched etc.) 23
  • 25.  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.S. (Ph I/II) POTELLIGENT® antibodies, KHK2866(HB-EGF) U.S. five KM-Mouse antibodies) ASKP1240(CD40) Immunology/ Japan (Ph I) U.S. (Ph II) Allergy With Astellas KHK4563(IL-5R) Japan KRN23(FGF23) Other U.S. : POTELLIGENT® Technology : KM-Mouse Technology 24
  • 26.  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 Pharmaceuticals Anti LIGHT Sanofi LIGHT (Except in Japan, Asia) Research KM-Mouse antibody 25
  • 27.  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-licensed POTELLIGENT® antibodies have entered clinical trials, including those by Bristol-Myers Squibb and Genentech. 26
  • 28.  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 antibody) KRN5500 DARA Peripheral neuropathy Cancer LY2523355 Eli Lilly (Mitotic kinesin Eg5 inhibitor) AMG 761 Allergy Amgen (KW-0761:POTELLIGENT®) (Anti-CCR4 antibody) RGI2001 REGiMMUNE Immunosuppressive 27
  • 29.  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 ArQule (c-met inhibitor) Crohn’s disease Asacol Zeria *as a treatment for ulcerative colitis RTA 402 Reata Diabetic nepropathy 28
  • 30.  KW-0761 UpdateKW-0761  An anti-CCR4 antibody using enhanced antibody manufacturing technology POTELLIGENT ® developed in-houseHematological cancer: Development update  Japan: ATL (Adult T-cell leukemia/lymphoma)  Ph I: Published in Journal of Clinical Oncology 28:1591-1598  Ph II: Clinical trial results announced at ASH, Dec. 2010  Application: Also in conjunction with companion diagnostics, Apr. 26, 2011  Launch: 2012 (planned)  Japan: Other clinical trials  ATL add-on therapy (for untreated patients): In Ph II clinical trials  Peripheral T/NK-cell lymphoma: In Ph II clinical trials  USA: PTCL, CTCL development (In Ph I/II clinical trials) Ph I: Interim report: T Cell Lymphoma Forum (Jan. 28-30, 2010) Ph I/II: Clinical trial results announced at ASH, Dec. 2010 29
  • 31.  Pipeline - Recent newsMain 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 subcutaneous injection  4/21 Announced completion of ProStrakan acquisition  4/26 Filed in Japan for manufacturing and sales of KW-0761 as treatment for ATL Filed in Japan for manufacturing and sales of KW-0761 companion diagnostics  5/10 KW-6002 (Parkinson’s disease treatment) released initial results of Phase III trials in Japan  5/24 Won Patanol® US patent infringement lawsuit against Apotex (released by Novartis)  6/2 POTELLIGENT® 18th outlicensing contract (to ImmunoCellular Therapeutics)  6/3 KW-6002: Termination of North America licensing agreement  6/29 KW-3357: Announced start of Phase III trials in Japan  7/26 KW-6500: Filed in Japan for manufacturing and sales  7/26 POTELLIGENT® 19th outlicensing contract (to arGEN-X) 30
  • 32. If you have any inquiries regarding this presentation please call:Corporate Communications Department, Kyowa Hakko Kirin Co., Ltd Tel: 03-3282-0009