Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — Q1 FY2019 Earnings Presentation
42 slides from Daiichi Sankyo's earnings presentation, Jul 31, 2019
Slide 1: FY2019 Q1 Financial Results Presentation
FY2019 Q1 Financial Results Presentation DAIICHI SANKYO CO., LTD Toshiaki Sai Executive Vice President and CFO July 31, 2019
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 Sa
Slide 3: Agenda
Agenda 1 FY2019 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 2
Slide 4: Overview of FY2019 Q1 Results
Overview of FY2019 Q1 Results (Bn JPY) FY2018 Q1 FY2019 Q1 YoY Results Results +10.4% Revenue 225.7 249.2 +23.5 Cost of Sales 84.7 87.9 +3.2 SG&A Expenses 65.6 63.2 -2.5 R&D Expenses 45.5 41.2 -4.3 +90.5% Operating Profit 29.9 57.0 +27.1 Profit before Tax 29.6 57.1 +27.4 +81.0% Profit attributable t
Slide 5: Revenue
Revenue Increased by 23.5 Bn JPY (Increased by 25.7 Bn JPY excl. forex impact) (Bn JPY) Positive Factors Negative Factors FY2018 Results FY2018 Results 225.7 Japan Lixiana +6.8 Japan Japan Nexium +2.1 (incl. Vaccines, OTC) 12.2 Pralia +1.6 (incl. Vaccines, OTC) Vimpat +1.3 Daiichi Sankyo, Inc. +1.2
Slide 6: Operating Profit
Operating Profit Increased by 27.1 Bn JPY (Increased by 19.0 Bn JPY excl. forex impact and special items) FY2018 Results FY2018 Results 29.9 増益 減益 (Bn JPY) Revenue +23.5 Revenue Revenue 23.5 incl. forex impact of -2.2 Cost of Sales +2.0 (Cost increased) Cost Cost ofofSales Sales 2.0 Product mix SG&A
Slide 7: Special Items
Special Items (Bn JPY) FY2018 Q1 FY2019 Q1 YoY Results Results Cost of Sales Restructuring costs in SC 1.3 +1.3 Gain on sales of SG&A Expenses fixed assets* -10.6 -10.6 R&D Expenses Total -9.3 -9.3 *Gain on sales of Nihonbashi building - : Cost decreased items Special items : Items having a transito
Slide 8: Profit Attributable to Owners of the Company
Profit Attributable to Owners of the Company Increased by 19.4 Bn JPY FY2018 Results FY2018 Results 24.0 Operating OperatingProfit Profit 27.1 (Bn JPY) Income Taxes etc. +8.1 (Cost increased) Financial Income/ Financial Income Expenses / Expensesetc. 0.3 FY2018 FY2019 YoY Profit before Tax 29.6 57.1
Slide 9: Revenue: Major Business Units (incl. Forex Impact)
Revenue: Major Business Units (incl. Forex Impact) (Bn JPY) FY2018 Q1 FY2019 Q1 YoY Results Results Japan 123.9 139.0 +15.0 Daiichi Sankyo Healthcare 18.4 15.4 -3.0 Daiichi Sankyo, Inc. 11.0 7.8 -3.1 Olmesartan 3.2 3.1 -0.1 Welchol 4.9 2.6 -2.3 American Regent, Inc. 28.6 36.0 +7.3 Injectafer 11.2 13
Slide 10: Revenue: Major Products in Japan
Revenue: Major Products in Japan (Bn JPY) FY2018 Q1 FY2019 Q1 YoY Results Results Lixiana anticoagulant 14.7 21.6 +6.8 Nexium ulcer treatment 19.8 21.9 +2.1 Memary Alzheimer’s disease treatment 12.9 13.7 +0.8 treatment for osteoporosis/ Pralia inhibitor of the progression of bone erosion associated
Slide 11: Business Update
1 FY2019 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 10
Slide 12: Japan Business: Continuous Launch of Own Products
Japan Business: Continuous Launch of Own Products Tarlige (for pain treatment) Minnebro (for hypertension) Launched in Apr. 2019 Launched in May 2019 Vanflyta Inavir nebulizer* formulation (for the treatment of (anti-influenza agent) relapsed/refractory FLT3-ITD Approved in Jun. 2019 AML) *device wh
Slide 13: Japan Business: Transfer Marketing Authorization Rights for Diagnostic Imaging Agents
Japan Business: Transfer Marketing Authorization Rights for Diagnostic Imaging Agents Optimization of business portfolio Transferred to GE Healthcare The diagnostic imaging agents to be transferred Revenue Product name Product description Launched in FY2018 Omnipaque Nonionic X-ray contrast ag
Slide 14: R&D Update
1 FY2019 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 13
Slide 15: R&D Topics
DS-8201 data published in The Lancet Oncology Interim data from U3-1402 NSCLC phase 1 study Interim data from DS-1062 NSCLC phase 1 study Interim data from DS-1001 glioma phase 1 study Updated data from pexidartinib TGCT phase 3 study Upcoming milestones Announcement of R&D Day 14
Slide 16: DS-8201: P1 Study The Lancet Oncology
DS-8201: P1 Study The Lancet Oncology Pertuzumab + T-DM1 T-DM1 T-DM1 Breast trastuzumab (1L, failed (2L)3 (3L+)4 DS-82015 + docetaxel (1L)1 study)2 mPFS 18.5m 14.1m 9.6m 6.2m 22.1m DoR 20.2m 20.7m 12.6m 9.7m 20.7m OS 56.5m 53.7m 30.9m 22.7m NR ORR 80% 60% 43.6% 31% 59.5% Median prior Rx 7 0 0 1 4 10
Slide 17: DS-8201: HER2 mBC and mGC Submission Plan
DS-8201: HER2 mBC and mGC Submission Plan Preparation for submissions is on track Breast EU 1H FY2020 Breast Breast US Japan 1H FY2019 2H FY2019 Gastric Japan 1H FY2020 SAKIGAKE or Breakthrough Therapy Designation Underlined in red: new or update from FY2018 Q4 16
Slide 18: U3-1402: P1 Dose Escalation/Expansion Study
U3-1402: P1 Dose Escalation/Expansion Study Dose Escalationa Dose Expansion Eligibility Metastatic/unresectable EGFR- Received ≥1 dose of U3-1402 IV Q3W: N = 23 mutant NSCLC and: • T790M-negative after 6.4 mg/kg, n = 5 Will enroll additional progression on erlotinib, Ongoing patients at the gefitini
Slide 19: U3-1402: P1 Study Patients Baseline Characteristics
U3-1402: P1 Study Patients Baseline Characteristics Dose escalation Dose escalation Baseline clinical characteristics Baseline disease characteristics (N = 23)a (N = 23)a Age, median (range), years 63.0 (51.0—80.0) Sites of metastases, n (%) CNSc 14 (60.9) Sex, n (%) Female 14 (60.9) Liver 9 (39.1)
Slide 20: U3-1402: P1 Study Safety TEAEs and DLT
U3-1402: P1 Study Safety TEAEs and DLT Percentage of patient with TEAEs (>=10%; N =23) Dose-limiting Toxicities(DLT) (N = 23) 0 20 40 60 80 100 3.2mg/kg Nausea Fatigue 4.8mg/kg Vomiting Decreased appetite 5.6mg/kg Platelet count decreased 6.4mg/kg Alopecia Epistaxis Gastroesophageal reflux disease D
Slide 21: U3-1402: P1 Study Efficacy Waterfall Chart
U3-1402: P1 Study Efficacy Waterfall Chart 40 N = 16 20 3.2 mg/kg 0 Best % change 4.8 mg/kg -20 6.4 mg/kg PR confirmed -40 PR partial response PR -60 PR -80 PR -100 EGFR activating mutationsa L858R L858R L858R L858R Ex19del Ex19del Ex19del L858R Ex19del Ex19del Ex19del Ex19del Ex19del L858R Ex19del
Slide 22: U3-1402: P1 Study Efficacy Spider Plot
U3-1402: P1 Study Efficacy Spider Plot 20 % change in tumor size 10 0 -10 -20 3.2 mg/kg -30 4.8 mg/kg -40 6.4 mg/kg -50 Discontinued -60 treatment -70 -80 -90 0 6 12 18 24 30 36 Time (weeks) Data cutoff date of February 25, 2019. Sixteen patients received ≥1 dose of U3-1402 and had pre- and post-tre
Slide 23: DS-1062: Relapsed NSCLC P1 Study
DS-1062: Relapsed NSCLC P1 Study NSCLC ≥ 3rd line Dose Escalation Dose Expansion n=40 in RDE POC MTD 3-6 subjects Assess efficacy and safety for 10 mg/kg, Q3W GO/NO-GO decision 3-6 subjects 8.0 mg/kg, Q3W Cohort 1-8 3-6 subjects 6.0 mg/kg, Q3W Following NSCLC POC Dose 3-6 subjects • Open 2 other exp
Slide 24: DS-1062: P1 Study Patients Baseline Characteristics
DS-1062: P1 Study Patients Baseline Characteristics DS-1062 doses, mg/kg Total Parameter 0.27(n=4) 0.5(n=5) 1.0(n=7) 2.0(n=6) 4.0(n=6) 6.0(n=8) 8.0(n=3) (N=39) Male sex, n (%) 1 (25.0) 3 (60.0) 4 (57.1) 4 (66.7) 2 (33.3) 6 (75.0) 3 (100) 23 (59.0) Age, y, median (range) 64.0 66.0 67.0 60.5 53.5 53.5
Slide 25: DS-1062: P1 Study Safety Summary
DS-1062: P1 Study Safety Summary TEAE, n (%) N=39 All grades Grade≧3a,b Any TEAE 34 (87.2) 16 (41.0) TEAE, preferred term (in ≥ 10% of patients) Fatigue 13 (33.3) 2 (5.1) Nausea 12 (30.8) 0 Anemia 9 (23.1) 0 Decreased appetite 9 (23.1) 0 Alopecia 8 (20.5) 0 Infusion related reaction 8 (20.5) 0 Const
Slide 26: DS-1062: P1 Study Efficacy Spider Plot
DS-1062: P1 Study Efficacy Spider Plot Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Tumor size (% change from baseline) 1 PR* 2 PR * 3 additional PRs were 1 PR 3 PR confirmed after data cut-off Circles indicate ongoing patients Small diamonds represent post-treatment response data
Slide 27: DS-1001: Mutant IDH1 Inhibitors
DS-1001: Mutant IDH1 Inhibitors MOA Mutant IDH1 is an enzyme that converts α-KG to 2-HG DS-1001 2-HG is an oncometabolite, accumulation of which leads to oncogenesis and subsequent clonal Mutant expansion via epigenetic dysregulation IDH1 Inhibition of mutant IDH1 enzymes α-ketoglutarate (R)
Slide 28: DS-1001: P1 Study Patients Baseline Characteristics
DS-1001: P1 Study Patients Baseline Characteristics Enhancing Non-enhancing Total Characteristic (n=35) (n=12) (N=47) Median age, years (range) 46.0 (29–77) 38.5 (28–49) 44.0 (28–77) Gender: male/female, n (%) 21 (60) / 14 (40) 8 (67) / 4 (33) 29 (62) / 18 (38) ECOG PS: 0/1/2, n (%) 19(54) / 13(37)
Slide 29: DS-1001: P1 Study Safety Summary
DS-1001: P1 Study Safety Summary AEs occurring in ≥10% of patients, regardless of causality Preferred term, n (%) a All grades (N=47) Grade ≥3 (N=47) One DLT was observed at a Skin hyperpigmentation 25 (53.2) 0 dose of 1000 mg bid Diarrhea 22 (46.8) 2 (4.3) Grade 3 WBC count decreased Pruritus 1
Slide 30: DS-1001: Efficacy Waterfall Chart
DS-1001: Efficacy Waterfall Chart • Enhancing (n=35) ORR: 17%(1CR, 5PR) Continued: 20% • Non-enhancing (n=12) ORR: 33% (4MR) Continued: 67% Minor Response (MR) in RANO-LGG Partial Response (PR) in RANO and RANO-LGG Data cutoff was on May 7, 2019. Enhancing gliomas were assessed by RANO criteria, and
Slide 31: Pexidartinib: Efficacy Update of TGCT
Pexidartinib: Efficacy Update of TGCT ASCO2019 ASCO2018 Long-term Treatment Pooled ENLIVEN Primary Endpoint Results Analysis (Updated ENLIVEN & Ph1) Pexidartinib Pexidartinib Placebo n=130* n=61 n=59 RECIST Best ORR (CR or PR), n 70 24 0 (%) (54%) （39%） Median treatment duration, 17 - - month (range
Slide 32: Pexidartinib: Hepatotoxicity Update of TGCT Patients
Pexidartinib: Hepatotoxicity Update of TGCT Patients ASCO 2019 ASCO 2018 Pexidartinib Pexidartinib Pexidartinib Pexidartinib Randomized Crossover Randomized Crossover (1000mg/d) (800mg/d) (1000mg/d) (800mg/d) n=61 n=30 n=61 n=30 ALT or AST ≧ 3 x, Tbili ≧ 2 x, 0 0 0 0 and ALP < 2 x ULN (Hy’s law) ALT
Slide 33: Upcoming Milestones
Upcoming Milestones HER2 positive mBC pivotal phase 2 study • US: BLA submission in 1H FY2019 Breast • JP: NDA submission in 2H FY2019 DS-8201 • EU: MAA submission in 1H FY2020 • Presentation at SABCS: December 2019 (planned) HER2 positive mGC pivotal phase 2 study Gastric • JP: NDA submission in 1H
Slide 34: Upcoming Milestones
Upcoming Milestones Relapsed/refractory FLT3-ITD AML • QuANTUM-R published in The Lancet Oncology in June 2019 Quizartinib AML • Japan: approved on June 18, 2019 • US: received CRL in June 2019 • EU: under review for 2H FY2019 approval Tenosynovial giant cell tumor • ENLIVEN published in The Lancet
Slide 35: Announcement of FY2019 R&D Day
Announcement of FY2019 R&D Day R&D Day in Tokyo Date December 17 (Tuesday) afternoon [live & on-demand casting planned] Sunao Manabe, CEO Speakers Antoine Yver, Global Head of Oncology R&D R&D Day in New York Date December 19 (Thursday) afternoon [on-demand casting planned] Sunao Manabe, CEO Speaker
Slide 36: Appendix
1 FY2019 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 35
Slide 37: FY2019 R&D Milestones
FY2019 R&D Milestones As of July 2019 FY2019 FY2020 Project Target Indications and Studies Q1 Q2 Q3 Q4 Q1~ P2 pivotal: breast cancer (HER2 positive post T-DM1) US submission JP submission EU submission P2 pivotal: gastric cancer (HER2 positive post trastuzumab) (JP/Asia) JP submission DS-8201 P2: ga
Slide 38: Major R&D Pipelines-1
Major R&D Pipelines-1 As of July 2019 Stage Generic Name/Project Code/ MOA Target Indication Region P1 P2 P3 NDA/BLA ★ Breast cancer (HER2 positive post T-DM1) JP/US/EU/Asia Breast cancer (HER2 positive vs T-DM1) JP/US/EU/Asia [fam-] trastuzumab deruxtecan/ Breast cancer (HER2 low expression) JP/US/
Slide 39: Major R&D Pipelines-2
Major R&D Pipelines-2 As of July 2019 Stage Generic Name/Project Code/ MOA Target Indication Region P1 P2 P3 NDA Pexidartinib/ Breakthrough Science Tenosynovial giant cell tumor US/EU CSF-1/KIT/FLT3 inhibitor ★ Oncology DS-1647(G47Δ)/oncolytic HSV-1 Malignant glioma JP DS-1001/ Mutant IDH1 inhibitor
Slide 40: Out-licensing Projects
Out-licensing Projects As of Jul 2019 Pre-clinical Phase 1 PLX7486: FMS/TRK inhibitor Solid tumor Oncology PLX8394: BRAF inhibitor Solid tumor PLX9486: KIT inhibitor Solid tumor (gastrointestinal stromal tumor) DS-1515: PI3Kδ inhibitor DS-2969: GyrB inhibitor Inflammatory disease Clostridium diffici
Slide 41: Listing of abbreviations
Listing of abbreviations Abbrevi English Implications ations AE Adverse event Undesirable experience associated with the use of a medical product in a patient BTD Breakthrough therapy designation Designation of innovative therapeutics CR Complete response Complete response (complete resolution of ca
Slide 42: Daiichi Sankyo Co., Ltd.
Inquiries about this document Daiichi Sankyo Co., Ltd. Corporate Communications Dept. TEL:+81-3-6225-1126 Email: DaiichiSankyoIR@daiichisankyo.co.jp
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