Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — JP Morgan Healthcare Conference 2016
37 slides from Daiichi Sankyo's conference presentation, 2016
Slide 1: Focus on Innovation
Focus on Innovation George Nakayama President and CEO Daiichi Sankyo Co., LTD. JP Morgan Healthcare Conference 2016
Slide 2: Forward-Looking Statements
Forward-Looking Statements Financial forecasts, future projections and R&D information that Daiichi Sankyo discloses may include information that might be classified as “Forward-Looking Statement”. These forward-looking statements represent our current assumptions based on information currently avai
Slide 3: Today's Agenda
Today’s Agenda Major Management Topics Background Edoxaban Japan Business US Business R&D Topics (Oncology Strategy) Conclusion 2
Slide 4: Today's Agenda
Today’s Agenda Major Management Topics Background Edoxaban Japan Business US Business R&D Topics (Oncology Strategy) Conclusion 3
Slide 5: Major Global Products
Major Global Products (USD M) *Currency rate : JPY/USD=120.0 anti-hypertension Olmesartan 2,502 (Benicar: US Olmetec: JP, EU) 2,446 2,384 2,157 206 225 242 173 547 401 544 483 Others EU 936 790 888 842 US Japan 793 813 789 817 FY2012 FY2013 FY2014 FY2015 （Estimate） (estimate) antiplatelet anticoagul
Slide 6: Management Focus
Management Focus Sustainable growth with smooth transition of key drivers Edoxaban Lixiana, Savaysa Prasugrel Olmesartan Effient, Efient Benicar, Olmetec etc Levofloxacin Pravastatin FY2007 FY2012 FY2016 FY2020 5 *The above figures do not include partner sales
Slide 7: Management Focus (cont.)
Management Focus (cont.) Strategies for growth beyond Olmesartan LOE Global Launch Edoxaban (Lixiana/Savaysa) & maximize its potential as a flag-ship product Achieve No. 1 market share by maximizing new Japan drugs Efient (Effient), Memary (Namenda), Nexium, Pralia (Prolia), Ranmark (Xgeva) etc. Lac
Slide 8: Today's Agenda
Today’s Agenda Major Management Topics Background Edoxaban Japan Business US Business R&D Topics (Oncology Strategy) Conclusion 7
Slide 9: Edoxaban: Competitive Advantage
Edoxaban: Competitive Advantage Oral, highly selective, direct, and reversible Factor Xa inhibitor The only once-daily NOAC that offers superiority compared to warfarin with less major bleeding in non-valvular atrial fibrillation and with less clinically relevant bleeding in DVT/PE The only NO
Slide 10: Edoxaban: Major Regions
Edoxaban: Major Regions Launched for DVT-OS in 2011 JPN Launched for AF and VTE in 2014 Sales growing steadily Revenue target: ~USD 100mn in FY2015 Launched for AF and VTE in 2015 US AF: indicated only for patients with CrCL ≤95 mL/min VTE: without limitation of use Ongoing negotiati
Slide 11: Edoxaban: Global Development
Edoxaban: Global Development Global revenue: USD 36M (FY2014)→USD 123M (FY2015 Plan) Switzerland: May 2015 UK: Jul. 2015 Japan Germany: Aug. 2015 DVT-OS: 2011 Ireland: Sep. 2015 AF, VTE: 2014 The Netherlands: Nov. 2015 (Launch) (Launch Dates) US: Feb. 2015 (Launch Date) (Approved) Korea: Aug. 2015 (
Slide 12: Today's Agenda
Today’s Agenda Major Management Topics Background Edoxaban Japan Business US Business R&D Topics (Oncology Strategy) Conclusion 11
Slide 13: Japan: Major Products
(USD M) Japan: Major Products *Currency rate : JPY/USD=120.0 For No.1 market share company in Japan anti-ulcer(PPI) treatment for alzheimer Nexium Memary (Namenda) 617 392 578 307 452 278 198 180 2012 2013 2014 2015 2012 2013 2014 2015 (estimate) （Plan） (estimate) （Plan） treatment for osteoprosis tr
Slide 14: Japan: Edoxaban
Japan: Edoxaban Steady sales growth Launched for DVT-OS in 2011 Launched for AF and VTE in 2014 Revenue target: ~USD 100mn in FY2015 M JPY (%) 14,000 Market Share: 12.5% 13 12,000 12 11 10,000 Product C 10 Product B 8,000 9 Product A 6,000 Lixiana 8 Lixiana (%) 4,000 7 2,000 6 ©2015 IMSHealth
Slide 15: Today's Agenda
Today’s Agenda Major Management Topics Background Edoxaban Japan Business US Business R&D Topics (Oncology Strategy) Conclusion 14
Slide 16: United States: Daiichi Sankyo
United States: Daiichi Sankyo Two Subsidiaries in US with marketing functions DSI: Daiichi Sankyo, Inc. • HQ Location: Parsippany, New Jersey • Other function: Research, development and packaging LPI: Luitpold Pharmaceuticals, Inc. • HQ Location: Shirley, New York • Other function: Research, develop
Slide 17: United States: Daiichi Sankyo
United States: Daiichi Sankyo DSI: Daiichi Sankyo, Inc. • HQ Location: Parsippany, New Jersey • Other function: Research, development and packaging 16
Slide 18: United States: DSI Portfolio
United States: DSI Portfolio To specialty products in CV, Pain and Oncology New products Current products CL-108 Pain Mirogabalin Tivantinib Quizartinib Patritumab Oncology Pexidartinib FY14 FY15 FY16 FY17 FY18 FY19 FY20 New Product Launches FY18~ CL-108 Mirogabalin Pexidartinib Quizartinib Patr
Slide 19: United States: DSI (cont.)
United States: DSI (cont.) Pain franchise: Near-term opportunities Three products targeting important, but unmet needs Opioid-induced Constipation (OIC) for patients taking opioids for chronic, non-cancer related pain Launched in U.S. May 2015 *Co-Commercialized by AstraZeneca & Daiichi Sankyo, Inc.
Slide 20: LPI: A Diversified Specialty Company
LPI: A Diversified Specialty Company Competitive among high value specialty-branded & generic injectable market segments IRON FRANCHISE (> 50% share of non HD segment) Venofer ® Injectafer® GENERIC INJECTABLE FRANCHISE 19
Slide 21: LPI: Positioned for Accelerated Growth
LPI: Positioned for Accelerated Growth Double-digit revenue and profit growth ($M)$ 714 522 395 * * * LE *Based on forecast 20
Slide 22: Today's Agenda
Today’s Agenda Major Management Topics Background Edoxaban Japan Business US Business R&D Topics (Oncology Strategy) Conclusion 21
Slide 23: R&D: Focus Therapeutic Areas
R&D: Focus Therapeutic Areas LCM and Late Markets Stage Early Dev Stage Dev Research Priority Areas for Discovery* Oncology Thrombosis - Oncology CV-M Hypertension - Cardiovascular-Metabolics Pain Pain - Pain *Discovery：Research and Early Development up to Proof of Concept 22 22
Slide 24: Major R&D Pipeline
Major R&D Pipeline As of October 2015 Therapeutic area Phase 1 Phase 2 Phase 3 Application DS-1040 CS-3150 (JP) Prasugrel (JP) Edoxaban (ASCA etc.) (Acute ischemic stroke / TAFIa inhibitor) (Hypertension ・ DM nephropathy / (CS-747 / ischemic stroke / anti- (DU-176b / AF / oral factor Xa MR a
Slide 25: R&D: Targets for Approval and Launch
R&D: Targets for Approval and Launch FY2015 FY2016 FY2017 FY2018 > FY2019 Cravit® Injection Hydromorphone Cancer Pain Pralia® RA Mirogabalin DPNP & PHN Oncology Nimotuzumab Japan Patritumab Cravit® Lacosamide Pexidartinib Tuberculosis Epilepsy Quizartinib (JPN) Zelboraf® (LCM) Artist® Efient® Ranmar
Slide 26: Daiichi Sankyo Oncology Strategy
Daiichi Sankyo Oncology Strategy Focus on first-in-class opportunities Develop personalized medicine based therapies Maintain strong academic partnerships National Cancer Center of Japan UCSF Max Planck Partner with innovative biotech companies ArQule Strategic acquisitions Plexx
Slide 27: R&D: Oncology Clinical Pipeline
R&D: Oncology Clinical Pipeline Phase 1 Phase 2 Phase 3 Growth U3-1565 (HB-EGF) Nimotuzumab Survival DS-3032 (MDM2) Patritumab (HER3) (EGFR) Receptors DS-8273 (DR5) ADC DS-8201 (HER2 ADC) ADC: Antibody Drug Conjugate DS-8895 (EPHA2) ADCC DS-5573 (B7-H3) ADCC: Antibody Dependent Cellular Cytotoxicity
Slide 28: Late Stage Oncology Projects
Late Stage Oncology Projects Four novel compounds targeting unique pathways in Phase 2/3 registration trials Quizartinib (Ph3) Pexidartinib (Ph3) • Acute myeloid leukemia (AML) • Tenosynovial giant cell tumor (TGCT) • TLR*: 1H 2017 • TLR: 1H 2018 Orphan Drug Designation by the FDA and EMA Orphan Dru
Slide 29: R&D: Next Generation of DS Oncology Portfolio
R&D: Next Generation of DS Oncology Portfolio Immuno-oncology • Immune checkpoint inhibitors • Cell therapy Epigenetics • IDH1 mutant inhibitor • EZH 1/2 inhibitor 28 28
Slide 30: Pexidartinib: PLX3397
Pexidartinib: PLX3397 Investigational CSF-1R (FMS) Inhibitor • Tenosynovial Giant Cell Tumor (TGCT) • Granted Orphan Drug Designation by the FDA and EMA • Granted Breakthrough Therapy Designation by FDA Further Investigations Collaboration with Merck: • Pexidartinib in combination with anti-PD-1 the
Slide 31: Pexidartinib in Combination with anti-PD-1 Therapy for Advanced Solid Tumors
Pexidartinib in Combination with anti-PD-1 Therapy for Advanced Solid Tumors Myeloid T CELL Suppressor PD-1 T-Cell- Cell PD-1 mAb Mediated Pembrolizumab Killing CSF1R PD-L1 CSF1* Pexidartinib SIGNAL GENE CANCER CELL * colony stimulating factor 1 30 30
Slide 32: R&D: Next Generation of DS Oncology Portfolio
R&D: Next Generation of DS Oncology Portfolio Immuno-oncology • Immune checkpoint inhibitors • Cell therapy Epigenetics • IDH1 mutant inhibitor • EZH 1/2 inhibitor 31 31
Slide 33: Epigenetic Targeting of Cancer Cells
Epigenetic Targeting of Cancer Cells • IDH1 mutant inhibitor decreases 2-hydroxyglutarate (2-HG) and improve transcriptional abnormality • EZH 1/2 inhibitor decreases histone methylation and increases transcription of tumor suppressor genes • Clinical studies of both inhibitors planned for 2016 IDH1
Slide 34: Today's Agenda
Today’s Agenda Major Management Topics Background Edoxaban Japan Business US Business R&D Topics (Oncology Strategy) Conclusion 33
Slide 35: Next 5-year Business Plan
Next 5-year Business Plan Period: FY2016 – FY2020 Contents: Strategies for solid growth from FY2018 Improve profit-generating capability Enhance R&D capabilities Improve shareholder value (ROE) etc. Announcement : March 2016 （億円） （億円） 14000 1600 12000 1400 10000 1200 8000 1000 6000 800 FY
Slide 36: Business Priorities
Business Priorities Core Business Concentrate on Innovative Business Core Regions Invest in Priority Regions: Japan/US/China Core Capabilities Enhance R&D Capabilities 35
Slide 37: Passion for Innovation. Compassion for Patients.
Passion for Innovation. TM Compassion for Patients. Contact address regarding this material Daiichi Sankyo Co., Ltd. Corporate Communications Department TEL: +81-3-6225-1126
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