Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — Q2 FY2012 Earnings Presentation
28 slides from Daiichi Sankyo's earnings presentation, Nov 1, 2012
Slide 1: Top Management Presentation
Top Management Presentation Financial Results for 2Q Fiscal 2012 (April 1 - September 30, 2012) Thursday, November 1, 2012 Joji Nakayama, President and CEO
Slide 2: Key Message for 2nd Half FY2012
Key Message for 2nd Half FY2012 1st Half FY2012 proceeded roughly to plan Absolutely committed to achieve full-year targets: Net sales ¥980.0 billion Operating income ¥100.0 billion Steady progress in major development projects Ranbaxy’s continuous growth and ongoing contribution to profit Maintenan
Slide 3: Financial Overview
Financial Overview O Daiichi-Sankyo
Slide 4: Overview of FY2012 2Q Results
Overview of FY2012 2Q Results - compared with FY2011 2Q results - Consolidated Income Statement Ranbaxy Group Note : Figures of Ranbaxy are pre-adjusted before consolidation FY2011 FY2012 FY2012 FY2011 FY2012 FY2012 (Jan-Dec) 2Q 2Q (Jan-Jun) (Jan-Jun) Results Results Forecast Progress Results Result
Slide 5: Net Sales factors
Overview of FY2012 2Q Results - compared with FY2011 2Q results - JPY Bn 400 420 440 460 480 500 520 FY2011 2Q Results 456.0 Japan Japan 20.1 ・New products: Memary +6.9, Nexium +1.8, Ranmark +1.7 ・Current products: Japan Impact of Olmetec・Rezaltas・Calblock -2.1 -16.0 Mevalotin -4.1 NHI Price Cut Net
Slide 6: Operating Income factors
Overview of FY2012 2Q Results - compared with FY2011 2Q results - JPY Bn 0 20 40 60 80 FY2011 2Q Results 62.2 Operating Income factors Japan Japan (Incl.DSHC) -4.5 ・ Enhanced promotion of new products ・ Negative impact on NHI price cut Global business ・Increase factors: Global Business RLL; Contribu
Slide 7: Ordinary Income and Net Income factors
Overview of FY2012 2Q Results - compared with FY2011 2Q results - JPY Bn 0 10 20 30 40 50 60 70 Ordinary Income factors FY2011 2Q Results 66.3 Operating Income -5.1 Non-operating Income -4.3 Non-operating income/expenses ・Increases in forex losses and loss on Non-operating Expenses -7.1 valuation of
Slide 8: Business Highlights
Business Highlights O Daiichi-Sankyo
Slide 9: Highlights Japan
Highlights Japan Steady achievement of existing mainstay product targets Olmetec ・ 46% of annual target achieved ・ Highest share growth rate in mono therapy market. ・ Continue to stronger prescription with lower dosage or higher dosage, and appeal its efficacy and durability by using evidence with
Slide 10: Highlights Japan
Highlights Japan Realize earlier popularization of new products Memary ・ 41% of annual target achieved ・ Accelerate promotion post the cancellation of dosage restriction period ・ Raise rates of combined treatment with Donepezil by strengthening approach towards specialists, speed up acquisition of
Slide 11: Highlights North America & Europe
Highlights North America & Europe Daiichi Sankyo Inc. （DSI） Olmesartan ・ 65% of annual target was achieved. franchise ・ Prevent competing generics from encroaching by improved patients’ supporting program Welchol ・ This year’s annual target is more than 14% higher than FY2011, and 50% has been a
Slide 12: Sales of Major Products
Sales of Major Products JPY Bn FY2011 FY2012 FY2012 2Q 2Q Results Results Forecast Progress Olmesartan 123.8 120.8 237.0 51% Prasugrel Global Sales Global Prasugrel 4.5 6.5 - - (alliance revenue) Mil. US$ 120 115.8 Loxonin 30.1 29.7 62.0 48% 111.0 109.7 Cravit 16.8 16.5 37.0 45% 100 90.9 Nexium 2.6
Slide 13: Highlights Ranbaxy
Highlights Ranbaxy Response to U.S. FDA and U.S. Department of Justice Taking solid steps under a consent decree conducted with FDA Taking steps to finalize issues raised by DOJ. Settlement expenses to be within $500 million provided for reserve thereof in FY2011 Achievements of FY2012 Maximiz
Slide 14: Highlights Next Mainstays
Highlights Next Mainstays Edoxaban （DU-176b） Aiming for Best in Class FXa inhibitor Steady progress in ENGAGE AF-TIMI 48 study, HOKUSAI VTE phase 3 study Prasugrel （CS-747） Expectations of commercial release in Japan Acute Coronary Patients undergoing PCI For coronary heart disease patients Es
Slide 15: Highlights Next Mainstays
Highlights Next Mainstays Tivantinib （ARQ 197） Speed up measures to secure indication Preparing phase 3 study for liver-cell cancer patients Proceeding with phase 2 study for colon cancer patients Denosumab （AMG 162） Osteoporosis, bound for approval and launch Japanese submission in March, 201
Slide 16: Future Schedule
Future Schedule Ranbaxy 2012 2012 3Q （Jan. to Sep.） announcement November Nov. 8 Thu. （Press release in Japanese issued on Nov. 9 ） December 2013 January Jan. 31 Thu. FY2012 3Q announcement February Ranbaxy Late Feb. 2012 4Q （Jan. to Dec.） announcement Announcement of March March 3rd Mid-term Manage
Slide 17: Global Research & Development
Global Research & Development Thursday, November 1, 2012 Glenn Gormley MD PhD Global Head of R&D Senior Executive Officer
Slide 18: Major R&D Pipeline
Major R&D Pipeline Therapeutic area Phase 1 Phase 2 Phase 3 Application ■ DS-7309 ■ CS-747 (US) ■ DU-176b (Global) (Anti-diabetes / Glucokinase activator) (Prasugrel / Sickle cell disease (Edoxaban / AF / oral factor Xa inhibitor) ■ DS-6930 / anti-platelet agent) ■ DU-176b (Global) (Anti-diabetes ■
Slide 19: Edoxaban (DU-176b): Once Daily Oral Factor Xa Inhibitor
Edoxaban (DU-176b) : Once Daily Oral Factor Xa Inhibitor Development by Daiichi Sankyo globally Indication Summary Phase 3 study, enrollment AF: ENGAGE AF-TIMI 48 completed in Nov 2010 Prevention of thromboembolic event in atrial fibrillation Study to be completed by FY2012-end (Mar 2013) VTE: HOKUS
Slide 20: Edoxaban (DU-176b): Competitive advantage
Edoxaban (DU-176b) : Competitive advantage The best dose-finding study in Phase 2 • Ensures the best balance in efficacy and safety The best Phase 3 studies in FXa class • The largest phase 3 studies • ENGAGE AF-TIMI 48 with over 21,000 • HOKUSAI VTE with over 8,250 • 2 doses in ENGAGE AF-TIMI 4
Slide 21: Prasugrel (CS-747): Anti-platelet agent
Prasugrel (CS-747) : Anti-platelet agent Co-development with Ube Industries in Japan, with Eli Lilly outside of Japan Indication Summary Japan domestic Phase 3 Top line results of PRASFIT-ACS was studies announced in Sep 2012 -ACS-PCI*:PRASFIT-ACS Elective-PCI study to be completed by -Elective-PCI
Slide 22: Prasugrel ACS-PCI Phase 3 in Japan: PRASFIT-ACS
Prasugrel ACS-PCI Phase 3 in Japan PRASFIT - ACS Multicenter, randomized, double-blind, double-dummy, parallel group study Evaluation of efficacy and safety of prasugrel in patients with ACS(UA, NSTEMI, STEMI) Prasugrel group（600subjects） ACS presentation LD/20mg MD/3.75mg qd Follow-up Visit Pre
Slide 23: Tivantinib (ARQ 197): Oral Met inhibitor
Tivantinib (ARQ 197) : Oral Met inhibitor Co-development with ArQule globally, except Japan，Asia Indication Summary Results presented at ASCO in HCC June 2012 (Hepatocellular Carcinoma) Phase 3 study is currently being planned CRC Phase 2 study ongoing (Colorectal Cancer) NSCLC Study has just been s
Slide 24: Denosumab (AMG 162): Anti-RANKL Antibody
Denosumab (AMG 162) : Anti- RANKL Antibody Development by Daiichi Sankyo in Japan Indication Summary NDA filed in Japan in Mar 2012 Osteoporosis: DIRECT Results presented at ASBMR in Oct 2012 Breast cancer adjuvant Phase 3 study ongoing Rheumatoid arthritis Phase 2 study ongoing Giant cell tumor Pha
Slide 25: Denosumab DIRECT Study: Incidence of Fragility Vertebral Fracture
Denosumab: DIRECT Study Incidence of New or Worsening vertebral fractures （%） 12 Placebo Incidence of Fragility Vertebral Fracture Placebo （n=480） Denosumab (n=472) 10.3% 10 HR：0.343 95%CI：0.194, 0.606 8 （p=0.0001） 65.7% 6 Denosumab 3.6% 4 2 0 0 6 12 18 24 Study Month Presented at 34th ASBMR in Oct
Slide 26: Denosumab DIRECT Study: Lumbar Spine BMD Levels
Denosumab: DIRECT Study Lumbar Spine BMD Levels （%） 12 Denosumab Placebo (Double-blind) 9.1% BMD Percent Change From Baseline Denosumab (Double-blind) 10 Alendronate (Open-label) 8 6 Alendronate 7.5% 4 9.0% Placebo 2 0.1% 0 -2 BL 3 6 12 18 24 Month Revision of the Presentation material at 34th ASBMR
Slide 27: Denosumab DIRECT Study: Summary of Adverse Events
Denosumab: DIRECT Study Summary of Adverse Events Double-blind Open-label Adverse Event Placebo Denosumab Alendronate (N=481) (N=475) (N=242) n (%) n (%) n (%) All 446 (92.7) 448 (94.3) 229 (94.6) Serious 68 (14.1) 66 (13.9) 30 (12.4) Death 5 (1.0) 5 (1.1) 0 (0.0) Leading to study discontinuation 2
Slide 28: Contact address regarding this material
Contact address regarding this material Daiichi Sankyo Co., Ltd. Corporate Communications Department TEL: +81-3-6225-1126 Each numerical value regarding the future prospect in this material is derived from our judgment and assumptions based on the currently available information and may include risk
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