Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — FY2015 Earnings Presentation
49 slides from Daiichi Sankyo's earnings presentation, May 12, 2016
Slide 1: Top Management Presentation: Financial Results of FY2015
Top Management Presentation Financial Results of FY2015 DAIICHI SANKYO CO., LTD Joji Nakayama President and CEO May 12, 2016
Slide 2: Forward-Looking Statements
Forward-Looking Statements Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo’s future prospects. These forward looking statements were determined by Daiichi
Slide 3: Agenda
Agenda FY2015 Consolidated Results FY2016 Consolidated Forecast, Shareholder Returns Major Management Topics Edoxaban Daiichi Sankyo, Inc. (DSI) R&D Topics 2
Slide 4: FY2015 Consolidated Results
FY2015 Consolidated Results 3
Slide 5: Overview of FY2015 Results
Overview of FY2015 Results (JPY Bn) FY2014 Results* FY2015 Results YoY +7.3% Revenue 919.4 986.4 +67.1 Cost of Sales 323.1 318.6 -4.5 SG&A Expenses 331.2 328.8 -2.4 R&D Expenses 190.7 208.7 +18.0 +75.2% Operating Profit 74.4 130.4 +56.0 Profit before Tax 79.9 122.4 +42.5 +77.1% Profit attributable t
Slide 6: Revenue
Revenue Increased by 67.1 JPY Bn due to the growth of Luitpold, Japan and ASCA with Forex (JPY Bn) FY2014 Results 919.4 Japan 18.4 (incl. Vaccines, OTC) Japan Positive : Nexium +13.1 Lixiana +9.4 Daiichi Sankyo, Inc. (US) 3.6 Teneria +9.0 Memary +5.6 Pralia +5.1 Efient +4.2 Ranmark +2.2 Luitpold (US
Slide 7: Operating Profit
Operating Profit Increased by 56.0 JPY Bn due to increased revenue and decreased expenses of special items (JPY Bn) FY2014 Results 74.4 Revenue +67.1 Revenue 74.4 67.1 incl. forex impact 12.9 Cost of Sales 26.7 Cost of Sales increase of revenue SG&A Expenses 114.8 2.5 R&D Expenses progress of projec
Slide 8: Special Items
Special Items (JPY Bn) FY2014 Results FY2015 Results YoY Restructuring costs in Japan 2.2 Gain on sales of subsidiary -2.4 Impairment loss (Intangible) 35.0 Gain on sales of fixed assets -1.1 Cost of Impairment loss (Intangible) 1.9 -34.2 Sales Restructuring costs in supply chain 4.6 Settlement expe
Slide 9: Profit Attributable to Owners of the Company
Profit Attributable to Owners of the Company Increased by 35.8 JPY Bn due to increased operating profit Forex loss due to strong Yen are booked as financial expenses (JPY Bn) FY2014 Results 46.5 Operating Profit 56.0 Financial Income / Expenses +14.2 FY2014: Forex gain Financial Income 14.2 FY2015:
Slide 10: Major Business Units
Major Business Units (JPY Bn) FY2014 FY2015 vs. Forecast YoY Results Results (%) Japan 480.5 494.7 +14.2 100.7% Daiichi Sankyo Healthcare 47.8 53.4 +5.5 108.9% Daiichi Sankyo Inc. 173.0 185.1 +12.1 105.2% Olmesartan 106.6 111.6 +5.1 110.5% Welchol 47.4 48.4 +1.0 102.9% Effient 17.6 20.7 +3.2 - Savay
Slide 11: Major Products in Japan
Major Products in Japan (JPY Bn) FY2014 FY2015 vs. Forecast YoY Results Results (%) Olmetec antihypertensive agent 76.3 73.9 -2.5 93.5% Nexium ulcer treatment 69.3 82.4 +13.1 107.0% Alzheimer’s disease Memary treatment 36.8 42.4 +5.6 90.3% Loxonin anti-inflammatory analgesic 49.5 48.1 -1.4 109.4% Cr
Slide 12: FY2016 Consolidated Forecast, Shareholder Returns
FY2016 Consolidated Forecast, Shareholder Returns 11
Slide 13: FY2016 Consolidated Forecast
FY2016 Consolidated Forecast (JPY Bn) FY2015 FY2016 Major factors YoY Results Forecast -6.7% Revenue 986.4 920.0 -66.4 See next page Cost of Sales 318.6 320.0 +1.4 Incl. approx. 20.0 Bn* Yen relating to SG&A Expenses 328.8 310.0 -18.8 restructuring costs etc. R&D Expenses 208.7 190.0 -18.7 Operating
Slide 14: Major Business Units FY2016 Forecast
Major Business Units FY2016 Forecast (JPY Bn) FY2015 FY2016 YoY Results Forecast Japan 494.7 496.0 +1.3 Daiichi Sankyo Healthcare 53.4 60.0 +6.6 Daiichi Sankyo Inc. 185.1 123.0 -62.1 Olmesartan 111.6 58.0 -53.6 Welchol 48.4 37.0 -11.4 Effient 20.7 - - Savaysa 0.4 2.0 +1.6 Movantik 2.0 - - Luitpold 9
Slide 15: Major Business Units FY2016 Forecast (Local Currency)
Major Business Units FY2016 Forecast (Local Currency) FY2015 FY2016 YoY Results Forecast Daiichi Sankyo Inc. (USD Mn) 1,540 1,118 -422 Olmesartan 929 527 -402 Welchol 403 336 -66 Effient 173 - - Savaysa 4 18 +14 Movantik 17 - - Luitpold (USD Mn) 758 836 +79 Venofer 260 227 -33 Injectafer 155 245 +90
Slide 16: Major Products in Japan FY2016 Forecast
Major Products in Japan FY2016 Forecast (JPY Bn) FY2015 FY2016 YoY Results Forecast Nexium ulcer treatment 82.4 80.0 -2.4 Olmetec antihypertensive agent 73.9 68.0 -5.9 Memary Alzheimer’s disease treatment 42.4 51.0 +8.6 Loxonin anti-inflammatory analgesic 48.1 37.0 -11.1 Teneria type 2 diabetes mell
Slide 17: Shareholder Returns
Shareholder Returns Annual ordinary dividend will be increased from 60 yen/share to 70 yen/share. (Yen) Second quarter Fiscal year-end Total FY2016 ordinary (Plan) dividend 35 35 70 ordinary dividend 30 30 60 FY2015 (Results) commemorative dividend 10 - 10 Shareholder returns policy during 5YBP T
Slide 18: Major Management Topics
Major Management Topics Edoxaban Daiichi Sankyo, Inc. (DSI) R&D Topics 17
Slide 19: Edoxaban: FY2016 Global Sales Forecast
Edoxaban： FY2016 Global Sales Forecast (JPY Bn) 36.3 US, others Realize rapid market penetration in Japan and Europe by highlighting unique product profile +21.3 EU 9.0 Japan The only Japan origin DOAC* 15.0 with 3 indications US, others Sales capabilities with high quality/credibility EU 1.5 Eu
Slide 20: Edoxaban: Marketing Structure in Europe
Edoxaban：Marketing Structure in Europe Maximize sales by partnering in countries with no DS sales subsidiary DSE promotes Lixiana in 18 countries and books sales. Germany, UK, Ireland, France, Spain, Portugal, Italy, Netherlands, Belgium, Luxembourg, Austria, Switzerland, Turkey etc. MSD promote
Slide 21: Major Management Topics
Major Management Topics Edoxaban Daiichi Sankyo, Inc. (DSI) R&D Topics 20
Slide 22: DSI: Shift in product portfolio
DSI: Shift in product portfolio With the LOE of key products DSI will transition from a mature primary care company to one with a differentiated specialty portfolio centered on Pain and Oncology New products Current products CL-108 Pain Mirogabalin Tivantinib Quizartinib Patritumab Oncology Pexi
Slide 23: DSI Commercial: Focus Shifts from PCP to New Specialty Product Portfolio
DSI Commercial: Focus Shifts from PCP to New Specialty Product Portfolio Before Restructuring After Restructuring 2015/10 2016/4 • Management • Management Sales Force • Specialty/Hospital • Specialty/Hospital Areas—US Commercial • Primary care Sales Force Positions—US Commercial 1,500* 750* DSI US C
Slide 24: Major Management Topics
Major Management Topics Edoxaban Daiichi Sankyo, Inc. (DSI) R&D Topics 23
Slide 25: R&D Topics
R&D Topics Progress of late-phase development pipeline Progress of oncology pipeline Four major late-phase development pipeline Four major early-phase development pipeline DS-6051 New phase 1 product PLX73086/AC708 PLX51107 Innovative technology: diving into cell therapy Research
Slide 26: Progress in late-phase pipeline to NDA
Progress in late-phase pipeline to NDA CL-108: Novel, opioid-containing formulation to treat moderate to severe pain while preventing or reducing opioid-induced nausea and vomiting (OINV) Charleston Laboratories, Inc. submitted NDA to U.S. Food and Drug Administration on March 2016 Targeted fo
Slide 27: Four major late-phase development pipeline
Four major late-phase development pipeline Update during Q4 FY2015 written in red TLR：anticipated Top Line Result Acute myeloid • Orphan Drug Designation by the FDA and EMA leukemia (AML) • Fast Track Status by the FDA 2nd line (P3) • Anticipating effectiveness to patients with FLT3-ITD patients Qui
Slide 28: Four major early-phase development pipeline
Four major early-phase development pipeline Update during Q4 FY2015 written in red • Anticipating effectiveness to patients resistant to treatment by Herceptin or Kadcyla DS-8201 Solid tumor • Applied DS proprietary ADC* technology (HER2-ADC) (P1) • Target: obtaining of phase 1 results in FY2017 • O
Slide 29: DS-6051: NTRK/ROS1 inhibitor
DS-6051: NTRK/ROS1 inhibitor Partial response in a patient who had prior crizotinib and ceritinib therapies with metastatic NSCLC ROS1+ w/ liver metastases was confirmed in Phase 1 study in US* First report for Ros1 inhibitor which is effective to a tumor patient who is resistant to crizotinib
Slide 30: DS-6051: NTRK/ROS1 inhibitor
DS-6051: NTRK/ROS1 inhibitor Diagnostic image of patient with Partial Response Observed anti-tumor effect Baseline (July 2015) After 9 weeks on therapy (September 2015) 29
Slide 31: New Phase 1 product: PLX73086/AC708
New Phase 1 product PLX73086/AC708: CSF-1R inhibitor Fast follow-on to Pexidartinib, potential best-in-class Improved selectivity relative to Pexidartinib Target indication: Tenosynovial Giant Cell Tumor (TGCT) Summary of the phase 1 study Study objectives • Primary: safety, PK&PD • Seco
Slide 32: New Phase 1 product: PLX51107
New Phase 1 product PLX51107: BRD4 inhibitor BRD4 A member of BET (Bromodomain and Extra-Terminal domain) protein family Recruit regulatory complexes to influence gene expression, especially oncogenes, such as c-MYC Epigenetic target potential PLX51107 inhibits the interaction between BR
Slide 33: Innovative technology: Diving into cell therapy
Innovative technology: Diving into cell therapy Cell therapy business environment A revolutionary therapeutic technology with full potential still to be defined Autologous vs. Allogeneic Autologous: Advanced technology with challenges about business potential to be defined Allogeneic: many
Slide 34: Innovative technology: New technology for cell therapeutics
Innovative technology: New technology for cell therapeutics In-licensed HeartcelTM technology from Cell Therapy Ltd, CTL, based in the UK CTL technology CTL has developed a novel and proprietary platform, based on the stem cell discoveries of Professor Sir Martin Evans, Nobel prize winner, which
Slide 35: Heartcel: Route of administration
Innovative technology: New technology for cell therapeutics Heartcel: Route of administration Intra-myocardial injection with CABG* Regeneration of ischemic scar tissue is expected by administration to the infarcted site of the heart A part of the licensing conditions Modified from ‘Understanding
Slide 36: Innovative technology: Research for new stem cell
Innovative technology: Research for new stem cell Started an collaborative research to develop new cell therapy on new stem cells with Asahikawa Medical University in April 2016 Therapeutic use of capillary stem cell (CapSCs) for various kinds of diseases in addition to a practical use of the Ca
Slide 37: Research for new stem cell: CapSCs transplantation
Innovative technology: Research for new stem cell Example of therapeutic effect of CapSCs transplantation experiment with model mice of sever lower leg ischemia. CapSC treatment dramatically inhibited necrosis of lower leg caused by ischemia Control group CapSCs group 36
Slide 38: Open innovation research scheme utilizing OiDE Fund
Open innovation research scheme utilizing OiDE Fund Equity investors Daiichi Sankyo, OiDE Fund Mitsubishi UFJ Capital, Organization for Small & Medium Enterprises and Daiichi Sankyo and Mitsubishi UFJ Regional Innovation, others 100%-owned Capital will seek out promising research results (“seeds”) a
Slide 39: Major R&D milestone events
Major R&D milestone events <Milestones towards NDA submission> Project Indication/Study Event Target CHS-0214 Rheumatoid arthritis (JP) NDA FY2016 （etanercept BS） Denosumab Rheumatoid arthritis (JP) NDA FY2016 Ischemic cerebrovascular disease Prasugrel Phase 3 study (JP) TLR* H1 FY2016 DS-8500 Type
Slide 40: Major R&D Pipeline
Major R&D Pipeline As of May 2016 Therapeutic area Phase 1 Phase 2 Phase 3 Application DS-3032 (US/JP) DS-8895 (JP) Patritumab (US/EU) Tivantinib (US/EU) (MDM2 inhibitor) (Anti-EPHA2 antibody) (U3-1287 / Anti-HER3 antibody) (ARQ 197 / HCC / MET inhibitor) PLX7486 (US) DS-8273 (US) Denos
Slide 41: Introducing Daiichi Sankyo Cancer Enterprise: Creating a transformation
Introducing Daiichi Sankyo Cancer Enterprise: Creating a transformation Executive VP & Global Head R&D Oncology Antoine Yver, MD MSc
Slide 42: Global Head, Oncology R&D, Antoine Yver
Global Head, Oncology R&D, Antoine Yver Former Pediatrician Oncologist, academic faculty Paris, France Former Head, Oncology Global Medicines Development at AstraZeneca (2009-2016) 26 years pharma experience in global R&D, including early & late phase development and licensing Global clinica
Slide 43: My values
My values Rigorous science, pursuing unique patient needs Simplicity, decentralized decision-making allowing autonomy and accountability Do the hard, right thing Take seriously what we do, don’t take ourselves seriously Be passionate and competitive externally Focus and prioritize Rele
Slide 44: DS opportunity in oncology
DS opportunity in oncology Needs In 2012, 8.2 million cancer-related deaths worldwide New cancer cases are expected to rise from 14 to 22 million within the next two decades World population is aging, and cancer rates increase with age Opportunity Six new US/Japan INDs for oncology agents in
Slide 45: Daiichi Sankyo Cancer Enterprise: Creating a transformation
Daiichi Sankyo Cancer Enterprise: Creating a transformation DS Cancer Enterprise: To lead in science and transform evidence into value for cancer patients in need 44
Slide 46: Enterprise: what do we mean?
Enterprise: what do we mean? “A professional firm seeking to achieve ultimate solutions for patients with cancer” “A dedicated group pursuing entrepreneurial behavior together, driven by each member’s initiatives, expertise and passion” Come together and work together beyond boundaries and titles
Slide 47: My Vision for DS Cancer Enterprise
My Vision for DS Cancer Enterprise: Be perfect in 3 areas Select with discipline the right molecules & technologies in which to invest Design efficient, effective & differentiated strategies and products based upon data, facts, observations and patient/customer/expert insights Deliver on our s
Slide 48: Transformation stemming from 4 pillars
Transformation stemming from 4 pillars Cancer Enterprise Select the most valuable & promising Refresh the Grow and assets to 2014-2015 Create the enrich talent ensure we Oncology R&D right support base and ways compete at our portfolio for the teams of working best, and strategy secure/ accelerate d
Slide 49: Contact address regarding this material
Contact address regarding this material Daiichi Sankyo Co., Ltd. Corporate Communications Department TEL: +81-3-6225-1126
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