Kyowa hakko kirin_e20120131_02

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Kyowa hakko kirin_e20120131_02

  1. 1. Kyowa Hakko Kirin Fiscal 2011 Results (Fiscal year to December 31, 2011) January 31, 2012 President & CEO Yuzuru Matsuda 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. 2. 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. 3. Summary of fiscal 2011 results 2
  4. 4.  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 figures. * The Chemicals segment is included in consolidation for the whole of fiscal 2010 and January-March period of fiscal 2011 and excluded from April 2011. 3
  5. 5.  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. 6.  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-consolidated) 5
  7. 7.  Pharmaceuticals business: Change in operating income 億円 (¥bn) 60.0 600 50.0 500 --6.3 63 +16.3 163 - 45 -4.5 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. 8. Bio-Chemicals and Summary of fiscal 2011 results: 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 Chemicals segment is included in consolidation for the January-March period of fiscal 2011 and excluded from April 2011. 7
  9. 9.  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. 10.  Bio-Chemicals business: Change in operating income (¥bn) 億円 40 4.0 - 0 -12 -1.2 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. 11. 2012 forecasts 10
  12. 12.  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 and excluded from April 2011. 11
  13. 13.  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. 14. Sales of core Fiscal 2012 full year forecasts: 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 17.3 12.2%↓ Coversyl 3.9 3.4 12.8%↓ Depakene 11.2 10.7 4.5%↓ Permax 2.1 2.0 4.8%↓ Asacol 2.8 4.1 46.4%↑ Exports and technology out-licensing revenues 22.3 33.3 49.3%↑ 13
  15. 15.  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. 16.  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 - -7.0 Other / Sales -6.0 6.0 +12.0 Eliminations OP 0.0 0.3 +0.3 Sales 454.0 326.0 -128.0 Total OP 51.7 48.0 -3.7 Pharmaceuticals: Negative factors include the effects of the National Health reimbursement prices while positive factors include the effects of the biosimilar JV. The acquisition of ProStrakan has a positive effect on sales and a negative effect on operating income from the amortization of goodwill, etc. Bio-Chemicals: Expecting amino acid sales volumes to be higher than forecast in the medium-term business plan but revenues and profits to be lower due to sluggish sales of core products at Daiichi Fine Chemical and the effects of a strong yen (Exchange rates employed: Medium-term plan ¥91/$, ¥133/€; FY2012 ¥77/$, ¥98/€) 15 Chemicals: The Chemicals segment has been eliminated
  17. 17. Pipeline 16
  18. 18.  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 Pegfilgrastim induced Injection Kirin-Amgen Asia: Korea and Vietnam Filed in Asia febrile neutropenia Cinacalcet Secondary Asia: The Philippines, Malaysia, Filed in Asia Oral Licensed from NPS Hydrochloride hyperparathyroidism Thailand and China Nephrology Approved in Darbepoetin Singapore Renal anemia injection Kirin-Amgen Alfa January (on dialysis) 2012 KW-6500 Filed Licensed from Apomorphine Parkinsons disease Injection July 2011 Britannia Pharma. Hydrochloride CNS Reinbursement of License from Valeant Filed in International SRL KW-6002 USA Parkinsons disease Oral In-house Istradefylline for the Development and Commercialization of KW-6002 in the US and Canada. AMG531 Idiopathic (Immune) Asia: Singapore and Taiwan (Approved in Other Filed in Asia Thrombocytopenic Injection Kirin-Amgen Malaysia on December 2) Romiplostim purpura *:KW-0761 is outlicensed to Amgen Inc. on March 6th,2008, with an exclusive right to develop and commercialize KW-0761 worldwide, except in Japan, Korea, China and Taiwan. Kyowa Hakko Kirin has retained the development and commercialization rights in these countries. In 2010, KHK paid Amgen US$20M for the buy-out of Amgens option to assume the development and commercialization of KW-0761 in oncology setting in Amgens licensed territory, which was granted under the License Agreement. Updated since August 2, 2011 ( Area, Stage, Filed, Approved, Launched etc.) 17
  19. 19.  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/Lymphoma, Add- Injection In-house Phase II antibody* on therapy (for untreated patients) Phase II Peripheral T/NK-cell Lymphoma KW-2246 Sublingual Licensed from Fentanyl Phase III Cancer pain tablet Orexo citrate KRN125 Chemotherapy induced febrile Phase III Injection Kirin-Amgen Pegfilgrastim neutropenia Oncology Phase II Gastric cancer in Japan and Korea ARQ 197 Oral Licensed from Phase III ArQule. in Japan, Korea and Lung cancer Taiwan Phase I/II KW-2478 In UK, USA, Multiple myeloma In-house Injection Philippines KRN321 Phase II ☆Myelodysplastic syndrome related Launched in Japan for anemia of Darbepoetin anemia Injection Kirin-Amgen in Japan and Korea CKD patients Alfa KRN1493 ☆HyperCalcemia with Licensed from Launched in Japan for Cinacalcet Phase III parathyroid carcinoma or intractable Oral primary hyperparathyroidism NPS Secondary Hyperparathyroidism Hydrochloride *:KW-0761 is outlicensed to Amgen Inc. on March 6th,2008, with an exclusive right to develop and commercialize KW-0761 worldwide, except in Japan, Korea, China and Taiwan. Kyowa Hakko Kirin has retained the development and commercialization rights in these countries. In 2010, KHK paid Amgen US$20M for the buy-out of Amgens option to assume the development and commercialization of KW-0761 in oncology setting in Amgens licensed territory, which was granted under the License Agreement. Updated since August 2, 2011 ( Area, Stage, Filed, Approved, Launched etc.) 18 ☆:New indication
  20. 20.  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-Amgen in China Renal anemia CKD patients Alfa Phase III (on dialysis) in India Phase II Organ Transplant ASKP1240 Phase I Injection In-house Jointly developed with Astellas in USA Rejection Immunology/ Being developed by MedImmune as Allergy KHK4563 Phase II MEDI-563 Worldwide except in Japan Asthma Injection In-House Benralizumab in Japan and Korea and other Asian Countries POTELLIGENT® antibody Z-206 Jointly developed with Zeria Licensed from Phase II ☆Crohns disease Oral Pharma launched in Japan for Mesalazine Zeria Pharma. ulcerative colitis KW-6002 Phase Parkinsons disease Oral In-house Istradefylline III CNS Licensed from KW-6485 Phase Janssen Launched in Japan for use as an ☆Pediatric epilepsy Oral Topiramate III Pharmaceutical epileptic drug K.K. Disseminated KW-3357 Phase Phase I in intravascular Developed Other Injection Antithrombin III Europe coagulation, Congenital In-house antithrombin deficiency ☆:New indication Updated since August 2, 2011 ( Area, Stage, Filed, Approved, Launched etc.) 19
  21. 21.  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 Injection In-house POTELLIGENT ® antibody in USA KRN951 Phase I Cancer Oral In-house Tivozanib Oncology Phase I POTELLIGENT ® antibody KHK2866 Cancer Injection in USA In-house Worldwide Outlicensed to Eli LY2523355 Lilly for the Development and Phase I Cancer Injection In-house Litronesib Commercialization of LY2523355 except Japan Jointly developed with Cephalon CEP-37250/ Phase Ⅰ Cancer Injection Cephalon POTELLIGENT® antibody KHK2804 in USA Phase Ⅰ POTELLIGENT® antibody KHK2898 Cancer Injection In-House in Singapore Updated since August 2, 2011 ( Area, Stage, Filed, Approved, Launched etc.) 20
  22. 22.  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 Psoriasis Injection Kirin-Amgen Allergy KHK6188 Phase I Neuropathic pain Oral In-house Other Phase I /II X-linked hypophosphatemic KRN23 in USA and Injection In-house rickets/Osteomalacia (XLH) Canada Updated since August 2, 2011 ( Area, Stage, Filed, Approved, Launched etc.) Withdrawal of Application Stage Developed in- Code name/ Category Other Indication Formulation house or Remarks Product name Japan licensed countries The withdrawal of application was made because currently submitted data is insufficient KRN321 to establish an evidence that Filed is necessary to attain the Oncology Darbepoetin Chemotherapy induced Anemia Injection Kirin-Amgen Nov/2008 approval, as a result of Alfa discussion with Pharmaceuticals and Medical Devices Agency. 21
  23. 23.  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) U.S. (Ph I/II) Cancer (five KHK2866 (HB-EGF) POTELLIGENT® U.S. antibodies, three KM-Mouse CEP-37250/KHK2804 With Cephalon Antibodies) U.S. KHK2898 (CD98) Singapore There are ASKP1240 (CD40) With Astellas development Japan (Ph I) U.S. (Ph II) Immunology/ candidates KHK4563 (IL-5R) Allergy Japan/Korea using both KHK4827 (IL-17R) technologies. Japan Kirin-Amgen KRN23 (FGF23) Other U.S./Canada (Ph I/II) : POTELLIGENT® technology : KM-Mouse technology 22
  24. 24.  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 Ph II Pharmaceuticals Anti LIGHT LIGHT Sanofi Research KM-Mouse antibody 23
  25. 25.  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-licensed POTELLIGENT® antibodies have entered clinical trials, including those by Bristol-Myers Squibb and Genentech. 24
  26. 26.  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 antibody) KRN5500 DARA Peripheral neuropathy Cancer LY2523355 Eli Lilly (Mitotic kinesin Eg5 inhibitor) AMG 761 Asthma Amgen (KW-0761:POTELLIGENT®) (Anti-CCR4 antibody) RGI2001 REGiMMUNE Immunosuppressive 25
  27. 27.  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 197 ArQule Gastric cancer (c-met inhibitor) Crohn’s disease Asacol Zeria *as a treatment for ulcerative colitis RTA 402 Reata Diabetic nepropathy Cancer KHK2804 Cephalon (Anti-tumor specific Glycoprotein Humanized Antibody) Psoriasis KHK4827 Kirin-Amgen (Anti-IL-17 receptor fully Human antibody) 26
  28. 28. Biosimilar joint venture with Fujifilm 27
  29. 29.  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 (planned) - Investment ratio 50:50 Aiming to begin clinical Development and trials in 2013 production of biosimilars Production, quality control and Biopharmaceutical research, analysis technology development and manufacturing Know-how to improve technology and technology, and knowhow production processes 28
  30. 30.  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 diagnosis  Improve capital expenditure efficiencies that use advanced engineering technologies  In the medium to long-term  Practical application of cutting-edge culture technologies  Practical application of new refining processes  KHK will use newly developed technologies for new drugs, JV will use newly developed technologies for biosimilar 29
  31. 31. Business in Asia 30
  32. 32.  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,Busulfex, Kirin Kunpeng (China) Bio Mitomycin C,Leunase,Coniel, Pharmaceutical Co., Ltd. Allelock Taiwan ¥2.0 bn Est. Apr. 1992 18 Nesp, Regpara,Gran, Kyowa Hakko Kirin Busulfex,MitomycinC, (Taiwan) Co., Ltd . Leunase Hong Kong ¥0.5 bn Est. Aug. 1993 5 Aranesp, Regpara,Renagel, Kyowa Hakko Kirin (Hong Busulfex,MitomycinC, Kong) Co., Ltd. Leunase Singapore ¥0.3 bn Est. Mar. 2005 6 Aranesp, Gran,Peglasta, Kyowa Hakko Kirin Busulfex,MitomycinC, Thailand (non-consolidated) (Singapore) Pte., Ltd. Leunase Kyowa Hakko Kirin(Thailand) Co., Ltd 31
  33. 33.  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 ◎ ◎ ◎ ◎ ☆ Neulasta ☆ ○ Nplate ○ ☆ ○ ○ ○ Busulfex ◎ ◎ ◎ ◎ ◎ ◎ ◎ Regpara ◎ ☆ ◎ ◎ ○ ☆ ☆ ☆ 32
  34. 34.  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 ☆ Phase 3 Phase 3 NSCLC ARQ (MRCT)*1 (MRCT)*1 197 Gastric Phase 2 Cancer (MRCT)*1 Phase 2 KHK4563 (MRCT)*1 Phase 1/2 KW‐2478 (MRCT)*1 Nesp Phase 2 MDS*2 (MRCT)*1 *1 MRCT: Multi Region Clinical Trial *2 Nesp MDS::Nesp treatment for Anemia from myelodysplastic syndrome 33
  35. 35. 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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