Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — Daiichi Sankyo Co Ltd Ord — Q1 2023 Earnings Presentation
37 slides from Daiichi Sankyo's earnings presentation, Jul 31, 2023
Slide 1: FY2023 Q1 Financial Results Presentation
FY2023 Q1 Financial Results Presentation DAIICHI SANKYO CO., LTD. Koji Ogawa Executive Officer, CFO July 31, 2023
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 FY2023 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 3
Slide 4: Overview of FY2023 Q1 Results
Overview of FY2023 Q1 Results (Bn JPY) FY2022 Q1 FY2023 Q1 YoY Results Results Revenue 280.3 350.8 +25.2% 70.5 Cost of sales * 74.7 93.6 18.9 SG&A expenses * 96.3 135.6 39.3 R&D expenses * 74.9 77.2 2.2 Core operating profit* 34.4 44.5 +29.4% 10.1 Temporary income* 0.0 0.5 0.5 Temporary expenses * -
Slide 5: Revenue
Revenue Increased by 70.5 Bn JPY (Increased by 59.0 Bn JPY excl. forex impact) (Bn JPY) Positive Factors Negative Factors FY2022 Q1 Q1Results 280.3 Japan Business Unit FY2022 Results Japan Business Lixiana +2.8 (incl. Innovative Pharmaceuticals, 0.0 Japan Business 12.2 Tarlige +2.8 Generic, Vaccines
Slide 6: Core Operating Profit
Core Operating Profit Increased by 10.1 Bn JPY (Increased by 10.0 Bn JPY excl. forex impact) (Bn JPY) FY2022 Q1 Q1 FY2022 Results Results 34.4 Revenue +70.5 incl. forex impact of +11.5 Revenue Revenue 70.5 Cost of Sales +15.6 CostCost of of Sales Sales 15.6 Increase in cost of sales due to the reven
Slide 7: Profit Attributable to Owners of the Company
Profit Attributable to Owners of the Company Increased by 38.2 Bn JPY FY2022 Q1 Q1 FY2022 Results Results 18.9 Core Core Operating (Bn JPY) Operating 10.1 Profit Profit Temporary Financial Income/Expenses etc. +13.0（Profit Increased） Temporary Revenue/ Revenue Expenses 0.4 • Improvement in forex gai
Slide 8: Revenue: Business Units (incl. Forex Impact)
Revenue: Business Units (incl. Forex Impact) (Bn JPY) FY2022 Q1 FY2023 Q1 YoY Results Results Japan Business 109.0 119.0 +10.0 Daiichi Sankyo Healthcare 15.3 17.1 +1.9 Oncolgy Business 27.5 70.6 +43.1 Enhertu 26.7 69.4 +42.7 Turalio 0.8 1.2 +0.4 American Regent 47.0 50.7 +3.6 Injectafer 14.1 13.2 -0
Slide 9: Revenue: Major Products in Japan
Revenue: Major Products in Japan (Bn JPY) FY2022 Q1 FY2023 Q1 YoY Results Results Lixiana anticoagulant 25.1 27.9 +2.8 treatment for osteoporosis/ inhibitor of the progression of Pralia bone erosion associated with rheumatoid arthritis 9.9 10.7 +0.8 Tarlige pain treatment 8.9 11.7 +2.8 Vimpat anti-e
Slide 10: Agenda
Agenda 1 FY2023 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 10
Slide 11: ENHERTU Revenue
ENHERTU® Revenue (Bn JPY) <Reference> FY2023 Q1 Results FY2023 Forecast Total YoY YoY Consideration Product Sales 81.7 50.4 320.0 112.5 - Japan 4.4 1.9 19.9 8.2 - US 51.6 31.5 195.1 50.5 - Europe 17.8 11.1 75.8 38.8 - ASCA 8.0 5.8 29.2 15.1 - 9.8 * 1 2.5 * 1 Upfront payment - - 149.0 2.1 * 11.6 * 1
Slide 12: ENHERTU Performance in Each Region (US, EU)
ENHERTU® Performance in Each Region (US, EU) Global product sales: FY2023 Q1 results 81.7 Bn JPY（YoY +50.4 Bn JPY）FY2023 forecast 320.0 Bn JPY（YoY +112.5 Bn JPY） US ◆ Product sales: FY2023Q1 results 51.6 Bn JPY (375 Mn USD) FY2023 forecast 195.1 Bn JPY (1.5 Bn USD) ◆ Indication: HER2+ mBC 2L+, HER2
Slide 13: ENHERTU Performance in Each Region (Japan, ASCA)
ENHERTU® Performance in Each Region (Japan, ASCA) Global product sales: FY2023 Q1 results 81.7 Bn JPY（YoY +50.4 Bn JPY）FY2023 forecast 320.0 Bn JPY（YoY +112.5 Bn JPY） Japan ◆ Product sales: FY2023Q1 results 4.4 Bn JPY FY2023 forecast 19.9 Bn JPY ◆ Indication: HER2+ mBC 2L+, HER2 low mBC (post-chemo)
Slide 14: Initiatives Related to Profit Growth for Current Business and Products in Japan
Initiatives Related to Profit Growth for Current Business and Products in Japan Enhance product portfolio ◆ VANFLYTAⓇ Anti-Cancer Agent /FLT3 Inhibitor ➢ Obtained partial change approval for acute myeloid leukemia (AML) 1L therapy in May 2023 Changed from "relapsed/refractory FLT3-ITD positive AML"
Slide 15: Agenda
Agenda 1 FY2023 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 15
Slide 16: 5DXd-ADCs Update
5DXd-ADCs Update Next Wave Update News Flow 16
Slide 17: Maximize 5DXd-ADCs Values
From “3 and Alpha” to “5DXd-ADCs and Next Wave” ENHERTU® Dato-DXd Maximize 3ADCs 5DXd-ADCs HER3-DXd 5DXd-ADCs & DS-7300 (I-DXd) Values DS-6000 Alpha (R-DXd) & Oncology Next Wave Specialty Medicine Next Pillars & Vaccine ENHERTU® : trastuzumab deruxtecan (International Nonproprietary Name: INN), T-DX
Slide 18: ENHERTU Promising antitumor activity in HER2+ mCRC patients
ENHERTU® Promising antitumor activity in HER2+ mCRC patients DESTINY-CRC02 study (ASCO 2023) DESTINY-CRC02 study suggests 5.4 mg/kg is the optimal dose 100 100 T-DXd 5.4 mg/kg Q3W Total (N = 82) 80 T-DXd 6.4 mg/kg Q3W Stage 1 (N = 40) cORR 27.5% [14.6-43.9]b 80 cORR 37.8% [27.3-49.2]b 60 60 Best % C
Slide 19: ENHERTU potential new treatment option for HER2 expressing solid tumors
Potential new treatment option for HER2 expressing ENHERTU® solid tumors DESTINY-PanTumor02 study (ASCO 2023) Demonstrated clinically meaningful activity across a broad range of HER2 expressing solid tumors (2L+) Objective Response Rate by HER2 status ◼ ORR: 37.1% in all patients (n=267) and 61.3% i
Slide 20: ENHERTU Primary analysis of DESTINY-PanTumor02 study
ENHERTU® Primary analysis of DESTINY-PanTumor02 study TLR from the primary analysis was acquired in Jul 2023 Interim Primary Analysis Analysis Cervical cancer ◼ Continued to show durable responses for ORR and DoR Endometrial cancer ◼ Demonstrated clinically meaningful Ovarian cancer PFS and OS resul
Slide 21: Dato-DXd Encouraging Combination Data in 1L NSCLC
Dato-DXd Encouraging Combination Data in 1L NSCLC TROPION-Lung02 study（ASCO 2023） Dato-DXd + Pembrolizumab (Doublet) and additional platinum chemotherapy (Triplet) demonstrated encouraging antitumor activity 80 Best change in sum of diameters from baseline, % 80 60 All patients (n=124)a 60 1L patien
Slide 22: Dato-DXd Path for establishing 2L/3L treatment in NSCLC
Dato-DXd Path for establishing 2L/3L treatment in NSCLC TROPION-Lung01 study Disclosed TLR in July 2023 Major Ph3 Clinical Studies of Dato-DXd in NSCLC Advanced/Metastatic Dato-DXd Advanced or 1L 2L 3L 6.0 mg/kg Randomization metastatic 1:1 NSCLC 2L/3L Docetaxel TROPION- N = 600 75 mg/m2 Lung07 (PD-
Slide 23: HER3-DXd HERTHENA-Lung01 study
HER3-DXd HERTHENA-Lung01 study Planned regulatory submission in US in FY2023 H2 Clinical studies of HER3-DXd ◼ Announced the TLR outline in FY2022 Q4 earnings call in EGFR mutated NSCLC • 5.6 mg/kg dose showed durable responses in patients with metastatic or locally advanced EGFR mutated NSCLC Advan
Slide 24: Additional updates in clinical studies and regulatory communications
5DXd-ADCs Additional updates in clinical studies and regulatory communications ENHERTU ® ◼ Jun 2023: Combination study with DS-1103 (anti-SIRPa antibody) started ◼ Jul 2023: Approved in China for chemo treated HER2 low BC (DESTINY-Breast04) DS-7300 ◼ Apr 2023: Orphan drug designation granted by FDA
Slide 25: Next Wave Update
5DXd-ADCs Update Next Wave Update News Flow 25
Slide 26: New project: DS-3939 starts Ph1/2 study
Next Wave New project: DS-3939 starts Ph1/2 study DXd-ADC directed TA-MUC1 (DAR: 8) Ph1/2 study in solid tumors is planned to start in FY2023 Q2 ◼ DS-3939 is an ADC developed by Ph1/2 Study Design combining an anti-TA-MUC1 antibody in-licensed from Glycotope GmbH (Berlin, Germany) and Daiichi Sankyo
Slide 27: New project: DS-1471 starts Ph1 study
Next Wave New project: DS-1471 starts Ph1 study DS-1471 is a monoclonal antibody targeting CD147 Ph1 study for solid tumors is planned to start in FY2023 H2 ◼ CD147 complex is important in survival, such as invasion and metastasis, in cancer tissues; also involved in embryogenesis and wound healing
Slide 28: Next Wave Clinical and Regulatory Progress
Next Wave Clinical and Regulatory Progress Vanflyta® (quizartinib) (FLT3-ITD positive acute myeloid leukemia [AML], 1L) ◼ May 2023: Approved in Japan ◼ Jul 2023: Approved in US Ezharmia® (valemetostat) (relapsed/refractory peripheral T-cell lymphoma [PTCL]) ◼ Jun 2023: TLR obtained DS-5670 (COVID-19
Slide 29: News Flow
5DXd-ADCs Update Next Wave update News Flow 29
Slide 30: FY2023 News Flow
FY2023 News Flow As of Jul 2023 Planned major publications Key data readouts WCLC (Sep 9-12, 2023) DESTINY-Breast06*: HR+ and HER2 low BC, chemo naïve, Ph3 ENHERTU® • FY2023 H2 DESTINY-Lung02: HER2 mutant NSCLC, 2L+, Ph2 ENHERTU® • Primary analysis data TROPION-Breast01*: HR+ and HER2 low or negativ
Slide 31: Agenda
Agenda 1 FY2023 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 31
Slide 32: Major R&D Milestones (5DXd-ADCs ①)
Major R&D Milestones (5DXd-ADCs ①) As of Jul 2023 Target Indication FY2023 Project H1 H2 FY2024 [phase, study name] • HER2 low, post chemo • Approved (China) [Ph3, DESTINY-Breast04] • HER2 low, chemo naïve • TLR anticipated [Ph3, DESTINY-Breast06] BC • HER2+, 1L • TLR anticipated [Ph3, DESTINY-Breas
Slide 33: Major R&D Milestones (5DXd-ADCs ②)
Major R&D Milestones (5DXd-ADCs ②) As of Jul 2023 Target Indication FY2023 Project H1 H2 FY2024 [phase, study name] NSCLC • 2/3L [Ph3, TROPION-Lung01] • TLR obtained • HR+ and HER2 low or negative BC, 2/3L Dato-DXd • TLR anticipated [Ph3, TROPION-Breast01] BC • TNBC, 1L • TLR anticipated [Ph3, TROPI
Slide 34: Major R&D Milestones (Next Wave)
Major R&D Milestones (Next Wave) As of Jul 2023 FY2023 Project Target Indication [phase, study name] FY2024 H1 H2 • Approval anticipated VANFLYTA® • AML, 1L [Ph3, QuANTUM-First] • Approved (JP/US) (EU) EZHARMIA® • r/r PTCL [Registrational Ph2, VALENTINE-PTCL01] • TLR obtained • HER2 expressing or mu
Slide 35: Major R&D Pipeline: 5DXd-ADCs
Major R&D Pipeline: 5DXd-ADCs As of Jul 2023 Phase 1 Phase 2 Phase 3 Filed (US/EU/Asia) HER2+ BC 2L+/1L (JP/US) solid tumors (US/EU/Asia) TNBC (JP/US/EU/Asia) solid tumors (JP/US/EU/Asia) HER2+ BC (JP/EU) HER2 mutant NSCLC 2L+ DESTINY-Breast07 TROPION-PanTumor01 (durvalumab combo) TROPION-PanTumor03
Slide 36: Major R&D Pipeline: Next Wave
Major R&D Pipeline: Next Wave As of Jul 2023 Phase 1 Phase 2 Phase 3 Filed DS-1055 (JP/US) DS-7011 (US) Valemetostat (DS-3201)(JP/US/EU/Asia) Pexidartinib (JP/Asia) Quizartinib (EU) Anti-GARP antibody Anti-TLR7 antibody EZH1/2 inhibitor CSF-1/KIT/FLT3 inhibitor FLT3 inhibitor Solid tumors Systemic l
Slide 37: Contact address regarding this material
Contact address regarding this material Daiichi Sankyo Co., Ltd. Corporate Communications Department TEL: +81-3-6225-1125 Email: DaiichiSankyoIR@daiichisankyo.co.jp
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