Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — FY2022 Q1 Earnings Presentation
43 slides from Daiichi Sankyo's earnings presentation, Jul 29, 2022
Slide 1: FY2022 Q1 Financial Results Presentation
FY2022 Q1 Financial Results Presentation DAIICHI SANKYO CO., LTD. Hiroyuki Okuzawa Director, Senior Executive Officer, CFO July 29, 2022
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 FY2022 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 3
Slide 4: Overview of FY2022 Q1 Results
Overview of FY2022 Q1 Results (Bn JPY) FY2021 Q1 FY2022 Q1 YoY Results Results Revenue 264.1 280.3 +6.2% 16.2 Cost of sales * 85.2 74.7 -10.5 SG&A expenses * 81.2 96.3 15.1 R&D expenses * 54.0 74.9 20.9 Core operating profit * 43.7 34.4 -21.3% -9.3 Temporary income * 2.1 0.0 -2.1 Temporary expenses
Slide 5: Revenue
Revenue Increased by 16.2 Bn JPY (Decreased by 1.1 Bn JPY excl. forex impact) (Bn JPY) Positive Factors Negative Factors FY2021 Q1 Results FY2021 Results 264.1 Japan Business Unit Japan Business Lixiana +2.2 Nexium -19.7 (incl. Innovative Pharmaceuticals, Japan Business 18.1 18.1 Tarlige +1.8 Generi
Slide 6: Core Operating Profit
Core Operating Profit Decreased by 9.3 Bn JPY (Decreased by 9.1 Bn JPY excl. forex impact) (Bn JPY) Revenue +16.2 FY2021 FY2021 Q1 Results Results 43.7 incl. forex impact of +17.3 Cost of Sales -14.2 Revenue 0.0 Revenue 16.2 Improvement in cost of sales ratio by change in product mix Cost ofofSales
Slide 7: Profit Attributable to Owners of the Company
Profit Attributable to Owners of the Company Decreased by 16.4 Bn JPY (Bn JPY) Temporary Revenue/Expenses +2.1 (Profit Decreased) FY2021 FY2021 Q1 Results Results 35.2 FY2021: Gains related to sale of Osaka logistics center (2.1) Core Core Operating Financial Income/Expenses etc. +6.2（Profit Decreas
Slide 8: Revenue: Business Units (incl. Forex Impact)
Revenue: Business Units (incl. Forex Impact) (Bn JPY) FY2021 Q1 FY2022 Q1 YoY Results Results Japan Business 129.1 109.0 -20.1 Daiichi Sankyo Healthcare 15.4 15.3 -0.1 Oncolgy Business 14.5 27.5 +13.1 Enhertu 10.8 26.7 +15.9 Turalio 0.6 0.8 +0.2 American Regent 39.1 47.0 +7.9 Injectafer 14.9 14.1 -0
Slide 9: Revenue: Major Products in Japan
Revenue: Major Products in Japan (Bn JPY) FY2021 Q1 FY2022 Q1 YoY Results Results Lixiana anticoagulant 22.9 25.1 +2.2 Tarlige pain treatment 7.1 8.9 +1.8 treatment for osteoporosis/ inhibitor of the progression of Pralia bone erosion associated with rheumatoid arthritis 9.2 9.9 +0.7 Efient antiplat
Slide 10: Agenda: Business Update
1 FY2021 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 10
Slide 11: ENHERTU Revenue
ENHERTU® Revenue <Reference> (Bn JPY) FY2022 Q1 Results FY2022 Forecast Total YoY YoY Consideration Product Sales 31.3 18.4 128.4 63.0 - Japan 2.4 0.3 16.0 6.4 - US 20.0 10.5 83.1 37.7 - Europe 6.7 5.5 23.0 14.0 - ASCA 2.2 2.2 6.3 4.9 - 2.5 * - 9.8 * - 149.0 1 1 Upfront payment 3.4 * 2.8 20.6 * 18.3
Slide 12: ENHERTU Performance in Each Region (US, EU)
ENHERTU® Performance in Each Region (US, EU) Steady increase in product sales due to market penetration and additional indication Global product sales: FY2022 Q1 results 31.3 Bn JPY（YoY +18.4 Bn JPY）FY2022 forecast 128.4 Bn JPY（YoY +63.0 Bn JPY） US Europe Product sales: FY2022 Q1 results 20.0 Bn J
Slide 13: ENHERTU Performance in Each Region (Japan, ASCA)
ENHERTU® Performance in Each Region (Japan, ASCA) Steady increase in product sales due to market penetration and increasing launched countries/regions Global product sales: FY2022 Q1 results 31.3 Bn JPY（YoY +18.4 Bn JPY）FY2022 forecast 128.4 Bn JPY（YoY +63.0 Bn JPY） Japan ASCA Product sales: FY202
Slide 14: Initiatives Related to Profit Growth for Current Business and Products
Initiatives Related to Profit Growth for Current Business and Products Enhance product portfolio in Japan Business REYVOWⓇ Migraine treatment Launched*1 in June 2022 *1 Eli Lilly Japan and Daiichi Sankyo signed an agreement on reverse co-promotion in which Eli Lilly Japan is responsible for clin
Slide 15: Agenda: R&D Update
1 FY2021 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 15
Slide 16: 3ADC Update, Alpha Update, News Flow
3ADC Update Alpha Update News Flow 16
Slide 17: ENHERTU DESTINY-Breast04 study
ENHERTU® DESTINY-Breast04 study Pioneer HER2 low BC as a new clinically meaningful patient segment ENHERTU® met the primary endpoint and all key secondary endpoints in the global Ph3 study for patients with HER2 low breast cancer previously treated with chemotherapy HER2 positive • IHC 3+ • IHC 2+
Slide 18: ENHERTU DESTINY-Breast04 data
ENHERTU® DESTINY-Breast04 data ASCO 2022 Highlights (Plenary Session) PFS in patients with HR+/HER2 low BC PFS in all patients with HR+ or HR-/HER2 low BC 49% reduction in the risk of disease progression or death 50% reduction in the risk of disease progression or death versus chemo, mPFS of 10.
Slide 19: ENHERTU DESTINY-Breast04 data
ENHERTU® DESTINY-Breast04 data ASCO 2022 Highlights (Plenary Session) OS in patients with HR+/HER2 low BC OS in all patients with HR+ or HR-/HER2 low BC 36% reduction in the risk of death versus chemo, mOS of 23.9m 36% reduction in the risk of death versus chemo, mOS of 23.4m compared to 17.5m w
Slide 20: ENHERTU Development of HER2 low breast cancer
ENHERTU® Development of HER2 low breast cancer Now conducting DESTINY-Breast06/08 studies in earlier lines of HER2 low breast cancer and further development is under discussion Endocrine therapy ± Chemotherapy 1L Chemotherapy 2L Chemotherapy 3L CDK4/6 inhibitor DESTINY-Breast06 Ph3 DESTINY-Breast04
Slide 21: ENHERTU DESTINY-Breast06/08 studies
ENHERTU® DESTINY-Breast06/08 studies DESTINY-Breast06 Ph3 study design Chemo naive ENHERTU® randomize HR+/HER2 low advanced or metastatic BC 1:1 Investigator’s choice of chemo N = 850 Endpoints: PFS, etc. DESTINY-Breast08 Ph1b study design Part 1 dose finding Part 2 dose expansion ENHERTU® + cap
Slide 22: ENHERTU DESTINY-Breast03 safety data update
ENHERTU® DESTINY-Breast03 safety data update ASCO 2022 Highlights The data reinforce the established favorable benefit/risk profile over T-DM1 in HER2+ BC Safety update overview (Sep 7, 2021) Adjudicated drug-related ILD/pneumonitis No new safety signals were observed for T-DXd No Gr4/5 ILD/pneu
Slide 23: ENHERTU FY2022 approval status
ENHERTU® FY2022 approval status HER2+ BC 2L May 2022: FDA approval based on Priority Review, Breakthrough Therapy Designation and Real Time Oncology Review program Jul 2022: EMA approval * Approval also obtained in the countries joining Project Orbis (Brazil, Australia, Israel, Canada, Switzerla
Slide 24: Dato-DXd BEGONIA study interim data
Dato-DXd BEGONIA study interim data ESMO BC 2022 Highlights Evidence of strong synergy between Dato-DXd and immune checkpoint inhibitor supports further development in TNBC Anti-tumor activity BEGONIA study Ph1b/2 study for TNBC 1L sponsored by AstraZeneca. Several drugs are tested for combination w
Slide 25: Dato-DXd New clinical study
Dato-DXd New clinical study TROPION-Breast02 study (TNBC 1L, Ph3) started in Jun 2022, TROPION-PanTumor02 study (NSCLC/TNBC, Ph1/2, China only) started in Jul 2022 TROPION-Breast02 Ph3 study design Dato-DXd Locally recurrent inoperable or metastatic randomize TNBC 1L* 1:1 Investigator’s choice of
Slide 26: HER3-DXd Breast cancer Ph1/2 study data
HER3-DXd Breast cancer Ph1/2 study data ASCO 2022 Highlights Clinically meaningful and durable responses were observed across breast cancer subtypes, responses were seen across a broad range of HER3 expression Anti-tumor activities (HR+/HER2-, TNBC, HER2+ cohorts) HR+/HER2- （ORR 30%, mDOR 7.2m）, T
Slide 27: HER3-DXd NSCLC Ph1 study cohort data
HER3-DXd NSCLC Ph1 study cohort 2 data ASCO 2022 Highlights The promising clinical activity of HER3-DXd in patients with NSCLC harboring a broad range of genomic alterations or without genomic alterations Anti-tumor activity (With (A) or Without (B) genomic alterations) Cohort 2 （A） Patients with ad
Slide 28: 3ADC Update, Alpha Update, News Flow
3ADC Update Alpha Update News Flow 28
Slide 29: DS-7300 ES-SCLC Ph2 study
DS-7300 ES-SCLC Ph2 study Development update Ph2 dose-finding study for ES-SCLC was initiated in June Ph1/2 study design ES-SCLC Ph2 study design Dose escalation (Part 1) DS-7300 8mg/kg Advanced/unresectable or 16.0 mg ES-SCLC randomize metastatic solid tumor 12.0 mg ／kg 2L or later 1:1 (various typ
Slide 30: DS-6000 Ovarian cancer/renal cell carcinoma Ph1 data
DS-6000 Ovarian cancer/renal cell carcinoma Ph1 data ASCO 2022 Highlights Tolerability and preliminary efficacy were observed in the interim Ph1 data DS-6000 was generally well tolerated DS-6000 demonstrated early clinical signals (RECIST and CA-125 responses) in heavily pretreated patients with
Slide 31: DXd-ADC Technology Grand prize for 6th Bioindustry awards
DXd-ADC Technology Grand prize for 6th Bioindustry awards Significant efficacy of ENHERTU® and future potential of DXd-ADC technology are recognized as breakthrough 5 researchers at Daiichi Sankyo received the grand prize for Bioindustry for ”Innovation of New Generation Antibody Drug Conjugate Te
Slide 32: Quizartinib QuANTUM-First study data
Quizartinib QuANTUM-First study data EHA 2022 Highlights (Presidential Symposium) Quizartinib + SOC doubled OS in patients with AML 1L with FLT3-ITD mutation vs SOC, regulatory submission planned in FY2022 H1 in JP/US/EU Primary Endpoint: OS QuANTUM-First study Ph3 study for patients with newly diag
Slide 33: DS-5670 Current development status
DS-5670 Current development status Development of COVID-19 vaccine progressed Ph1/2 study Development of initial vaccination H1 ‒ Dose setting Ph2 study Study design FY2021 • Results presented no significant safety concerns. • Subjects: COVID-19 unvaccinated Japanese Dose setting H2 • The neutrali
Slide 34: DS-5670 Current development status
DS-5670 Current development status Development of COVID-19 vaccine progressed Ph1/2 study Development of booster vaccination H1 ‒ Ph1/2/3 study Part 1 was completed ‒ Efficacy: Data on neutralizing activities four weeks after receiving the vaccination FY2021 show that the efficacy of DS-5670 is co
Slide 35: DS-2325 New clinical study
DS-2325 （KLK5 inhibitor） New clinical study Target Disease Netherton syndrome – An autosomal recessive genetic disease affecting skin, hair and immune system – Caused by mutations in the SPINK5 gene, which encodes LEKTI, a serine protease inhibitor – Incidence is estimated at 1/200,000-1/300,000 b
Slide 36: 3ADC Update, Alpha Update, News Flow
3ADC Update Alpha Update News Flow 36
Slide 37: FY2022 Future News Flow
FY2022 Future News Flow As of Jul 2022 Planned major publications Planned regulator y submissions World Conference on Lung Cancer (WCLC, Aug 6-9, 2022) DESTINY-Breast04: HER2 low BC, post chemo, Ph3 ENHERTU® TROPION-Lung02: NSCLC without actionable gene • CN: FY2022 H1 Dato-DXd mutation, Ph1b, pembr
Slide 38: Agenda: Appendix
Agenda 1 FY2022 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 38
Slide 39: Major R&D Milestones (3ADCs)
Major R&D Milestones (3ADCs) As of Jul 2022 FY2022 FY2023 Project Target Indication [phase, study name] H1 H2 • HER2+, 3L [P3, DESTINY-Breast02] • TLR anticipated • Approval • HER2+, 2L [P3, DESTINY-Breast03] • Approved (US/EU) anticipated (JP) BC • Filing accepted (JP/US/EU) • Approval • Approval •
Slide 40: Major R&D Milestones (Alpha)
Major R&D Milestones (Alpha) As of Jul 2022 FY2022 FY2023 Project Target Indication [phase, study name] H1 H2 DS-7300 • ES-SCLC, 2L [P2, JP/US/EU/Asia] • Study started • Approval • Filing anticipated Quizartinib • AML, 1L [P3, JP/US/EU/Asia] anticipated (JP/US/EU) (JP/US/EU) Valemetostat • Approval
Slide 41: Major R&D Pipeline: 3ADCs
Major R&D Pipeline: 3ADCs As of Jul 2022 Phase 1 Phase 2 Phase 3 Filed (US/EU/Asia) HER2+ BC 2L~/1L (JP/US) NSCLC, TNBC, HR+ BC, SCLC, (US/EU/Asia) TNBC (JP/US/EU/Asia) HER2+ BC 3L (JP/US/EU/Asia) HER2+ BC 2L DESTINY-Breast07 urothelial, GC, esophageal, etc. (durvalumab combo) DESTINY-Breast02 DESTI
Slide 42: Major R&D Pipeline: Alpha
Major R&D Pipeline: Alpha As of Jul 2022 Phase 1 Phase 2 Phase 3 Filed DS-7300 (JP/US) PLX2853 (US) Valemetostat (DS-3201) (JP/US/EU/Asia) Pexidartinib (JP/Asia) Valemetostat (DS-3201) (JP) B7-H3-directed ADC BET inhibitor EZH1/2 inhibitor CSF-1/KIT/FLT3 inhibitor EZH1/2 inhibitor ESCC, CRPC, squamo
Slide 43: 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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