Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — H1 2012 Earnings Presentation
52 slides from Kyowa Kirin's earnings presentation, Jul 27, 2012
Slide 1: FY December 2012 Interim Results Meeting
FY December ２０１２ Interim Results Meeting Kyowa Hakko Kirin Co., Ltd. President and CEO Nobuo Hanai July 27, 2012
Slide 2: Safe harbor statement
Safe harbor statement This document contains certain forward-looking statements relating to such items as the company’s (including its domestic and overseas subsidiaries) forecasts, targets and plans. These forward-looking statements are based upon information available to the company at the present
Slide 3: Interim results highlights
Interim results highlights Pharmaceuticals business ・Drug prices cut in April, but revenues up year-on-year ・Share of erythropoiesis stimulating agent (ESA) market up, centered on NESP® ・Launch of POTELIGIO® and POTELIGIO® TEST for adult T-cell leukemia- lymphoma (ATL) ・Price listing of Apokyn® for
Slide 4: Overview of Results
KYOWA KIRIN Overview of Results
Slide 5: Consolidated income statement
Consolidated income statement (¥ billion) Change Forecast at start Actual Results Result from last of term relative to FY interim Jan-Jun 2011 Jan-Jun 2012 Jan-Jun 2012 forecast term Net Sales 186.3 166.2 -20.0 163.0 +2% Operating 29.9 25.5 -4.3 22.5 +14% income Recurring 30.2 23.0 -7.1 19.5 +18% in
Slide 6: Pharmaceuticals business
Pharmaceuticals business （¥ billion） Change Forecast at Result Actual Results from last start of term relative to FY interim Jan-Jun 2011 Jan-Jun 2012 term Jan-Jun 2012 forecast Net Sales 112.5 122.8 +10.2 120.0 +2% Operating 25.1 23.3 -1.7 21.5 +9% income R&D 20.4 20.5 +0.1 22.3 - 8% expenses 5 4
Slide 7: Pharmaceutical Business: Analysis of sales changes
Pharmaceutical Business: Analysis of sales changes • Domestic drug sales （down ¥3.3 billion）：Despite growth in sales of Nesp, Fentos, Regpara and other products, lower airborne pollen counts than in the previous year depressed sales of Allelock and Patanol. The largest negative impact was caused by
Slide 8: Pharmaceutical Business: Analysis of operating income changes
Pharmaceutical Business: Analysis of operating income changes • Gross profit (up ¥7.9 billion): Decrease in gross profit from domestic drug sales offset by increase in FUJIFILM KYOWA KIRIN BIOLOGICS licensing income and new consolidation of ProStrakan (¥bn) • Increase in SG&A costs （up ¥9.6 billion)
Slide 9: Bio-Chemicals business
Bio-Chemicals business （¥ billion） Change Forecast at Result Actual Results from last start of term relative to FY interim Jan-Jun 2011 Jan-Jun 2012 term Jan-Jun 2012 forecast Net sales 40.3 40.0 -0.2 40.0 0% Operating 2.5 2.0 -0.4 0.8 +155.0% income 8 7
Slide 10: Bio-chemical business: Analysis of sales changes
Bio-chemical business: Analysis of sales changes • Domestic sales (up ¥0.2 billion): Growth in mail order sales and increased revenue due to the sale and manufacture of tranexamic acid by Daiichi Fine Chemical (¥bn) • Overseas sales (down ¥0.5 billion): price hike of amino acids offset by the impact
Slide 11: Bio-chemical Business: Analysis of operating income changes
Bio-chemical Business: Analysis of operating income changes • Gross profit (down ¥0.3 billion): The negative profit impact of the strong yen more than offset the price hike for amino acid exports and the increase in mail order sales of Ornithine, which were boosted by improved brand recognition (¥bn
Slide 12: Exchange rates
Exchange rates Exchange rate (average for accounting period) Change from Jan-Jun2011 Jan-Jun 2012 last FY interim term US dollar ¥82 ¥80 -¥2 Euro ¥115 ¥103 -¥12 British pound ¥133 ¥126 -¥7 Impact of exchange rates Jan-Jun 2012: impact on profits （vs. same period of last FY） Pharmaceuticals Bio-Chemi
Slide 13: Sales of major products
KYOWA KIRIN Sales of major products 12
Slide 14: Sales of major products (domestic)
Sales of major products (domestic) （¥ billion） Change Forecast at start Actual Results Result from last of term relative to Jan-Jun FY interim Jan-Jun 2012 Jan-Jun 2012 forecast 2011 term Nesp 25.4 26.8 +5% 25.5 +5% Espo 2.7 1.9 -29% 2.0 -5% Regpara 5.3 6.2 +17% 6.3 -1% Allelock 18.1 16.1 -11% 16.9
Slide 15: Sales of major products (ProStrakan)
Sales of major products (ProStrakan) (Million pounds) Change Forecast at Result Actual Results from last start of term relative FY interim to Jan-Jun 2011 Jan-Jun 2012 term Jan-Jun 2012 forecast Sancuso 4 5 +47% 7 -14% Abstral 12 16 +29% 18 -9% Tostran 2 2 +32% 2 +46% Xomolix 4 4 -7% 4 +6% Rectogesi
Slide 16: Full year forecasts
KYOWA KIRIN Full year forecasts 15
Slide 17: Consolidated income statement
Consolidated income statement (¥ billion) Actual Revised Forecast at result (1) forecast (2) start of term (3) Difference Change between original and (2) – (1) revised forecast Jan-Dec 2011 Jan-Dec 2012 Jan-Dec 2012 (2) - (3) Net Sales 343.7 333.0 -10.7 326.0 +7.0 Operating income 46.6 52.0 +5.4 48.
Slide 18: Pharmaceuticals business
Pharmaceuticals business (¥ billion) Actual Revised Forecast at Difference results (1) forecast (2) start of term (3) between Change original and (2) – (1) revised Jan-Dec 2011 Jan-Dec 2012 Jan-Dec 2012 forecast (2) - (3) Net sales 229.3 248.0 +18.7 242.0 +6.0 Operating 41.3 48.7 +7.4 45.7 +3.0 inco
Slide 19: FY2012 forecasts for sales of major products
FY2012 forecasts for sales of major products (¥ billion) Fiscal 2012 Change Fiscal 2012 Fiscal 2011 Revised forecasts y/y Original forecast Nesp 56.4 53.7 -5% 50.5 Espo 5.3 4.0 -25% 4.0 Regpara 11.5 13.0 +13% 13.1 Allelock 29.1 29.1 +0% 29.7 Patanol 11.4 10.1 -12% 11.3 Gran 14.8 13.4 -9% 13.3 Fentos
Slide 20: FY2012 forecasts for sales of major products (ProStrakan)
FY2012 forecasts for sales of major products (ProStrakan) （GBP million） Fiscal 2012 Change Fiscal 2012 Fiscal 2011 Revised Original forecast y/y forecast Sancuso 9 16 +76% 16 Abstral 27 36 +34% 38 Tostran 5 4 -10% 4 Xomolix 8 9 +6% 9 Rectogesic 9 9 +6% 10 Adcal D3 24 25 +3% 24 Others 20 37 +83% 38 1
Slide 21: Bio-Chemicals business
Bio-Chemicals business (¥ billion) Forecast at Difference Actual Revised between start of term Results (1) forecast (2) Change original and (3) (2) - (1) revised Jan-Dec forecast Jan-Dec 2011 Jan-Dec 2012 2012 (2) – (3) Net sales 77.5 79.0 +1.4 78.0 +1.0 Operating 2.8 3.0 +0.1 2.0 +1.0 income 20 18
Slide 22: FY 2012 forecasts (Forex)
FY 2012 forecasts （Forex） （Exchange rate average for FY 2012） Forecast at Difference Actual Revised between start of term Result (1) forecast (2) Change original and (3) (2) - (1) revised forecast Jan-Dec 2011 Jan-Dec 2012 Jan-Dec 2012 (2) – (3) USD ¥80 ¥81 + ¥1 ¥77 + ¥4 EUR ¥111 ¥102 -¥9 ¥98 + ¥4 G
Slide 23: Pharmaceuticals business highlights
Pharmaceuticals business highlights 22
Slide 24: Established presence in nephrology
Established presence in nephrology Multiple product offerings centered on chronic kidney disease (CKD) Supporting healthcare professionals through comprehensive information provision Risk factors: Chronic kidney disease Diabetes, Hypertension etc. Stage1 Stage 2 Stage 3 Stage 4 Stage 5: Chronic rena
Slide 25: Renal anemia agent: NESP
Renal anemia agent: NESP NESP: Accumulated evidence from five years of clinical experience since launch Pre-Dialysis phase Dialysis phase CKD stage ～4 5 5 D (renal failure) Varying the period between administration to take account of CKD disease progression and appropriately manage Hb Administration
Slide 26: Launch of world's first POTELLIGENT antibody
Launch of world’s first POTELLIGENT® antibody Promote individualized medicine through launch of antibody pharmaceuticals and companion diagnostics POTELIGEO ® TEST POTELIGEO ® Infusion March 2012: Approved March 2012: Approved May 2012: Launched May 2012: Launched CCR4 positive diagnosis Indic
Slide 27: Global development of KW-0761
Global development of KW-0761 Accelerating development strategy to maximize KW-0761 value Clinical trials for T-cell Lymphoma Japan US Europe ATL*1 Launched: Recurrent or refractory Phase 2: Phase 2 Original combination PTCL*2 Phase 2 Phase 2 Phase 1/2 CTCL*3 Phase 3 (planned) Companion diagnostics
Slide 28: Strategic alliance with Otsuka Pharmaceutical
Strategic alliance with Otsuka Pharmaceutical Enhancing product line-up in kidney disease (core therapeutic area) and advancing drug development in oncology Aims of strategic alliance Kyowa Hakko Kirin secures exclusive Pursue strategic alliance in Japan and Japanese development and marketing Asia f
Slide 29: The DPP-4 inhibitor saxagliptin
The DPP-4 inhibitor saxagliptin Japanese guidelines for clinical evaluation of oral hypoglycemic agents The first DPP-4 inhibitor filed in Japan after implementation of the Japanese guidelines US guidance for Industry. Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies
Slide 30: Update on biosimilar business
Update on biosimilar business FUJIFILM KYOWA KIRIN BIOLOGICS(FKB) is accelerating towards start of clinical trials in 2013 Business plan: FKB’s strength One biosimilar agent per year into clinical trials from 2013 Biopharmaceutical First product Humira; 4 product launches planned manufacturing t
Slide 31: Development pipeline
KYOWA KIRIN Development pipeline 30
Slide 32: Development pipeline progress
Development pipeline progress Pipeline progress over the three-month period since the Q1 results announcement Domestic May: Launched POTELIGEO® for adult T-cell leukemia-lymphoma May: Kyowa Medex launched in vitro diagnostic POTELIGEO® TEST May: Began phase II studies on KHK6188, a postherpeti
Slide 33: Phase III product pipeline (1)
Phase III product pipeline (1) Development Annual Expected Code Indication Location Phase Incidence filling date Relapsed/refractory Japan Launched (Launched ATL (Launched in in 2012) 2012) in 2012 st 1,100 1)1) 1,100 Naive ATL, 1 line combination therapy Japan Late Ph2 2013 2013 KW-0761 Japan 1,800
Slide 34: Phase III product pipeline (2)
Phase III product pipeline (2) Development Expected Code Indication Location Phase Prevalence filling date Chemotherapy- KRN125 induced febrile Japan Ph3 664,398 11 )) 664,398 2013 2013 neutropenia Japan Ph3 115,000 115,000 2012 KW-2246 Cancer pain 22 )) 2012 Disseminated Intravascular KW-3357 Coagu
Slide 35: Phase III product pipeline (3)
Phase III product pipeline (3) Development Expected Code Indication Location Phase Prevalence filling date KW-6500 Parkinson's Japan Launched in 2012* 139,000 139,000 1)1) (Launchd (Launchd in in 2012) 2012) Disease Parkinson's KW-6002 Disease Japan NDA 139,000 139,000 1)1) (Filed (Filed in in 2012)
Slide 36: Next major project: ARQ 197
Next major project: ARQ 197 Structure / MoA Clinical Trial Status c-Met1) inhibitor Clinical Stage: Phase III (ATTENTION study) Region: Japan, South Korea and Taiwan Indication: Non-small cell lung cancer (NSCLC) Dosing Route: Oral Number of Patients: 460 Primary Endpoint: Overall surviv
Slide 37: ARQ 197: future prospects
ARQ 197: future prospects Non-small cell lung cancer Hepatocellular carcinoma J Clin Oncol 28:18s, 2010 (suppl; abstr LBA7502) J Clin Oncol 30, 2012 (suppl; abstr 4006) 2009 2014 (million USD) 150 Euro mil. 100 Japan 505 730 Japan China 50 2008 2013 0 2007 2008 2009 2010 Year China 307 648 Sales of
Slide 38: Next major project: RTA 402
Next major project: RTA 402 Structure / MoA Clinical Trial Status Antioxidant inflammation modulator via Nrf2 1) Clinical Stage: Phase II Region: Japan Indication: CKD in patients with type 2 diabetes Dosing Route: Oral Number of Patients: 40 Primary Endpoint: Changes in eGFR from baseli
Slide 39: RTA 402: overseas data
RTA 402: overseas data Phase IIb results Improvement in eFGR* sustained over 52 weeks * eGFR: estimated glomerular filtration rate Pergola, et al. NEJM, 365;4, 327-36. July, 2011 Phase III results Study design: RTA402 (20mg) and placebo, 1:1 randomized, controlled study Subjects: CKD stage 4 with ac
Slide 40: Second half timeline
Second half timeline Domestic Launch Parkinson’s disease agent Apokyn® File for approval of KW-2246 in development for cancer pain Begin phase I study on ARQ197 in hepatocellular carcinoma Overseas Begin US phase III studies on KW-0761 in CTLC 39
Slide 41: Enquiries regarding this document
Enquiries regarding this document should be directed to: Kyowa Hakko Kirin Corporate Communications Department: 81-3- 3282-0009 40 40
Slide 42: Fiscal 2012 full year forecasts relative to medium-term plan
Fiscal 2012 full year forecasts relative to medium-term plan Medium-term Current FY2012 (¥bn) plan forecast Difference Sales 225.0 248.0 +23.0 Pharmaceuticals OP 36.4 48.7 +12.3 R&D expense 40.0 41.0 +1.0 Sales 88.0 79.0 -9.0 Bio-Chemicals OP 8.4 3.0 -5.4 Sales 147.0 － -147.0 Chemicals OP 7.0 － -7.0
Slide 43: Reference materials
KYOWA KIRIN Reference materials 42
Slide 44: Development pipeline details
Reference materials Development pipeline details 43 43
Slide 45: Development pipeline (1)
Development pipeline (1) (On file/approved) Denotes development progress since 18 April 2012 (region, development stage, filing, approval, launch etc) Development number Generic name Mechanism of action Target disease Development stage In-house/licensed Notes Presentation/Formulation Approved S. Kor
Slide 46: Development pipeline (2)
Development pipeline (2) (Phase II-III) ☆: New indication Development number Development In-house or Generic name Mechanism of action Target disease Notes stage licensed Presentation/Formulation KW-2246 Japan Marketed by Fentanyl citrate Opioid receptor agonist Cancer pain Orexo Phase III ProStrakan
Slide 47: Development pipeline (3)
Development pipeline (3) (Phase II-III) Denotes development progress since 18 April 2012 (region, development stage, filing, approval, launch etc) ☆: New indication Development number In-house or Generic name Mechanism of action Target disease Development stage licensed Notes Presentation/Formulatio
Slide 48: Development pipeline (4)
Development pipeline (4) (Phase I) ☆: New indication Development code Development In-house or Generic name Mechanism of action Target disease Notes stage Licensed Presentation/formulation KW-2450 IGF-1 receptor signal inhibitor US Malignant tumors In-house Oral Phase I/II KRN330 Anti-A33complete hum
Slide 49: Progress with out-licensing
Progress with out-licensing Phase Name Partner(s) Remarks I II III Tivozanib AVEO Malignant tumors (KRN951) Astellas (VEGF receptor inhibitor) KW-2871 Malignant tumors Life Science (Low-fucose antibody) (Anti-GD3 antibody) MEDI-563 Asthma MedImmune (KHK4563:POTELLIGENT®) (Anti-IL-5R antibody) KRN550
Slide 50: POTELLIGENT technology alliances
POTELLIGENT® technology alliances Product alliances Joint R&D Out-licensing Joint R&D POTELLIGENT® CHOK1SV Technology licenses (18 companies) Bristol-Myers Squibb biogen idec Agensys FivePrime CSL Limited NB: 7 licensed POTELLIGENT® antibodies have entered clinical trials up to the present time, inc
Slide 51: Antibody development pipeline (1)
Antibody development pipeline (1) Therapeutic area Development code Phase I Phase II Phase III On file KW-0761 ATL (treatment naïve) (Japan) Peripheral T/NK-cell lymphoma (Japan) Launched in Japan on 29 May Peripheral T-Cell lymphoma (EU) 2012 for relapsing or refractory CCR4-positive ATL PTCL, CTCL
Slide 52: Antibody development pipeline (2)
Antibody development pipeline (2) Therapeutic area Development code Phase I Phase II Phase III On file ASKP1240 Prevention of transplant rejection (US) With Astellas As above (Japan) Immunology/ KHK4563 Bronchial asthma (Japan, South Korea) Allergy KHK4827 Psoriasis (Japan) From Kirin-Amgen KW-0761