Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — Daiichi Sankyo Co Ltd Ord — Q2 2023 Earnings Presentation
53 slides from Daiichi Sankyo's earnings presentation, Oct 31, 2023
Slide 1: FY2023 Q2 Financial Results Presentation
FY2023 Q2 Financial Results Presentation DAIICHI SANKYO CO., LTD. Hiroyuki Okuzawa Representative Director, President & COO October 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 Q2 Financial Results 2 Strategic Collaboration 3 FY2023 Forecast/ Annual Dividend 4 Business Update 5 R&D Update 6 Appendix 3
Slide 4: Overview of FY2023 Q2 Results
Overview of FY2023 Q2 Results (Bn JPY) FY2022 Q2 YTD FY2023 Q2 YTD YoY Results Results Revenue 607.8 726.3 +19.5% 118.5 Cost of sales * 159.4 188.4 29.0 SG&A expenses * 209.8 276.6 66.9 R&D expenses * 153.9 166.0 12.2 Core operating profit * 84.8 95.3 +12.4% 10.5 Temporary income* 10.8 0.7 -10.1 Tem
Slide 5: Revenue
Revenue Increased by 118.5 Bn JPY (Increased by 93.0 Bn JPY excl. forex impact) (Bn JPY) Positive Factors Negative Factors FY2022 Q2 YTD FY2022 Results Q2 YTD Results 607.8 Japan Business Unit Japan Business Lixiana +6.4 Japan Business0.0 (incl. Innovative Pharmaceuticals, 18.7 Generic, Vaccines, OT
Slide 6: Core Operating Profit
Core Operating Profit Increased by 10.5 Bn JPY (Increased by 7.7 Bn JPY excl. forex impact) (Bn JPY) Revenue +118.5 incl. forex impact of +25.5 FY2022 Q2 YTD FY2022 Q2 YTD Results Results 84.8 +22.9 Cost of Sales Revenue Increase in cost of sales due to the revenue increase Revenue 118.5 SG&A Expens
Slide 7: Profit Attributable to Owners of the Company
Profit Attributable to Owners of the Company Increased by 38.7 Bn JPY (Bn JPY) Temporary Income/Expenses -11.0 (Profit decreased) FY2022 Q2 FY2023 Q2 YoY YTD YTD FY2022 Q2 YTD Temporary Income 10.8*1 0.7 -10.1 FY2022 Q2 YTD Results Results 58.3 Temporary Expenses 0 1.0 +0.9 Core Core Operating *1 Ga
Slide 8: Revenue: Business Units (incl. Forex Impact)
Revenue: Business Units (incl. Forex Impact) (Bn JPY) FY2022 Q2 YTD FY2023 Q2 YTD YoY Results Results Japan Business 225.1 246.8 +21.8 Daiichi Sankyo Healthcare 33.6 37.4 +3.8 Oncolgy Business 70.7 148.8 +78.1 Enhertu 69.0 145.1 +76.1 Turalio 1.7 2.6 +0.9 American Regent 94.1 98.7 +4.6 Injectafer 27
Slide 9: Revenue: Major Products in Japan
Revenue: Major Products in Japan (Bn JPY) FY2022 Q2 YTD FY2023 Q2 YTD YoY Results Results Lixiana anticoagulant 50.7 57.1 +6.4 treatment for osteoporosis/ inhibitor of the progression of Pralia bone erosion associated with rheumatoid arthritis 19.3 21.1 +1.7 Tarlige pain treatment 18.3 22.7 +4.4 Vim
Slide 10: Agenda
Agenda 1 FY2023 Q2 Financial Results 2 Strategic Collaboration 3 FY2023 Forecast/ Annual Dividend 4 Business Update 5 R&D Update 6 Appendix 10
Slide 11: Overview of Strategic Collaboration
Overview of Strategic Collaboration ◆ Co-development and co-commercialization of HER3-DXd, I-DXd (DS‐7300), R-DXd (DS-6000) with Merck & Co., Inc., Rahway, NJ, USA (MRK) ➢ Maximize the value of 3 products by accelerating and expanding development ➢ Allocate resource rapidly with flexibility to new g
Slide 12: Financial Terms for Strategic Collaboration
Financial Terms for Strategic Collaboration Up to 22.0 Bn USD (3,300.0 Bn JPY) in total (1USD=150JPY) Upfront payments 4.5 Bn USD (675.0 Bn JPY) : 1.5 Bn USD×3 products I-DXd R-DXd MRK may elect not to pay the two upfront payments HER3-DXd Total of 0.75 Bn USD each that are due after 12 months （DS‐7
Slide 13: How R&D Expenses will be Shared, and How Cash will be Paid
How R&D Expenses will be Shared, and How Cash will be Paid ◆ How R&D expenses for 3 products will be shared between the companies R&D expenses for each product ① MRK will be responsible for 75% of the first 2 Bn USD of R&D expenses 50% 50% for each product (MRK will bear 0.5 Bn USD (25% of 2 Bn USD)
Slide 14: Agenda
Agenda 1 FY2023 Q2 Financial Results 2 Strategic Collaboration 3 FY2023 Forecast/ Annual Dividend 4 Business Update 5 R&D Update 6 Appendix 14
Slide 15: Revision to the forecast
Revision to the forecast (Bn JPY) FY2023 FY2023 Revenue vs. Forecast : Increase by forex, sales increase mainly driven by Enhertu growth, Forecast Forecast increase by deferred revenue of upfront payment associated with strategic as of Apr. (as of Apr.) (as of Oct.) collaboration with Merck & Co., I
Slide 16: Revision of Annual Dividend
Revision of Annual Dividend Increase FY2023 annual dividend forecast per share from 34 JPY to 40 JPY Revised annual dividend per share: 40 JPY (interim dividend: 20 JPY, year-end dividend: 20 JPY) ◆ FY2023 annual dividend forecast announced on Apr. 27, 2023 Capital efficiency improvement Shareholder
Slide 17: Agenda
Agenda 1 FY2023 Q2 Financial Results 2 Strategic Collaboration 3 FY2023 Forecast/ Annual Dividend 4 Business Update 5 R&D Update 6 Appendix 17
Slide 18: ENHERTU Revenue
ENHERTU® Revenue (Bn JPY) FY2023 Q2 Results FY2023 Forecast <Reference> Total vs. Forecast YoY Consideration as of Apr. Product Sales 173.4 93.9 381.7 61.7 - Japan 10.4 5.2 21.5 1.6 - US 105.9 50.5 229.5 34.4 - Europe 39.2 25.6 92.8 17.0 - ASCA 17.9 12.6 37.8 8.6 - 9.8 * 1 4.9 * 1 Upfront payment -
Slide 19: ENHERTU Performance in Each Region (US, EU)
ENHERTU® Performance in Each Region (US, EU) Global product sales: FY2023Q2 YTD results 173.4 Bn JPY（YoY +93.9 Bn JPY）FY2023 forecast 381.7 Bn JPY（vs. Forecast as of Apr. +61.7 Bn JPY） US ◆ Product sales: FY2023Q2 YTD results 105.9 Bn JPY (751 Mn USD) FY2023 forecast 229.5 Bn JPY (1,605 Mn USD) ◆ In
Slide 20: ENHERTU Performance in Each Region (Japan, ASCA)
ENHERTU® Performance in Each Region (Japan, ASCA) Global product sales: FY2023Q2 YTD results 173.4 Bn JPY（YoY +93.9 Bn JPY）FY2023 forecast 381.7 Bn JPY（vs. Forecast as of Apr. +61.7 Bn JPY） Japan ◆ Product sales: FY2023Q2 YTD results 10.4 Bn JPY FY2023 forecast 21.5 Bn JPY ◆ Indication: HER2+ mBC 2L
Slide 21: LIXIANA: Growth in Each Country/Region
LIXIANAⓇ: Growth in Each Country/Region Volume Global revenue FY2023 Q2 YTD results: 137.7 Bn JPY (YoY +20.4 Bn JPY) FY2023 forecast: 277.3 Bn JPY (YoY +33.4 Bn JPY) 45% 42.7% Japan 40% 36.6% S. Korea 35% 27.0% Taiwan 30% 25.7% Belgium 25% 24.1% UK 20% 22.6% Spain 22.5% Italy 15% 18.0% Germany 10% 4
Slide 22: LIXIANA: Growth in Japan
LIXIANAⓇ: Growth in Japan Sales ◆ No.1 sales share (FY2023 Q2: 45.4%) ◆ Revenue FY2023 Q2 YTD results: 57.1 Bn JPY (YoY +6.4 Bn JPY) FY2023 forecast: 112.9 Bn JPY (YoY +7.7 Bn JPY) （%） 50 Decrease in sales share due to （45.4%） drug price revision (special expansion re-pricing) 40 30 20 LIXIANAⓇ Prod
Slide 23: Major Update on Patent Disputes
Major Update on Patent Disputes Dispute with Seagen(SGN) regarding Daiichi Sankyo antibody drug conjugates ◆ In October 2023, the U.S. District Court for the Eastern District of Texas issued an amended final judgment ➢ The Court’s amended final judgment requires DS to pay SGN a royalty of 8% on sale
Slide 24: Agenda
Agenda 1 FY2023 Q2 Financial Results 2 Strategic Collaboration 3 FY2023 Forecast/ Annual Dividend 4 Business Update 5 R&D Update 6 Appendix 24
Slide 25: 5DXd-ADCs Update
5DXd-ADCs Update Next Wave Update R&D day News Flow 25
Slide 26: ENHERTU Two Breakthrough Therapy Designations
ENHERTU® Two Breakthrough Therapy Designations DESTINY-PanTumor02 & DESTINY-CRC01/02 Expand leadership across HER2-targetable tumors ◼ ENHERTU ® is the first HER2 directed therapy to demonstrate a potential benefit across a series of difficult-to-treat cancers. ◼ ENHERTU ® has been granted additiona
Slide 27: ENHERTU DESTINY-PanTumor02
ENHERTU® DESTINY-PanTumor02 ESMO 2023 DESTINY-PanTumor02 demonstrated clinically meaningful and durable responses across a broad range of HER2 expressing advanced solid tumors Analysis of ORR by investigator was performed in patients who received ≥1 dose of T-DXd; all patients (n=267; including 67 p
Slide 28: ENHERTU Additional updates in clinical studies and regulatory communications
ENHERTU® Additional updates in clinical studies and regulatory communications HER2 mutant NSCLC, 2L+ ◼ Aug 2023: Approval in Japan ◼ Sep 2023: Recommended for approval in EU by CHMP ◼ Oct 2023: Approval in EU DESTINY-PanTumor01 study (HER2 mutant solid tumors) ◼ Oct 2023: Data presentation at ESMO 2
Slide 29: Dato-DXd TROPION-Lung01 overall efficacy in NSCLC 2/3L
Dato-DXd TROPION-Lung01 overall efficacy in NSCLC 2/3L ESMO 2023 Dato-DXd is the first ADC to demonstrate a statistically significant improvement in PFS over docetaxel in NSCLC PFS for ITT PFS in Key Subgroups ◼ Met dual primary endpoint of PFS Data cutoff: Mar 2023 ◼ Hazard Ratio: 0.75 (95% CI, 0.6
Slide 30: Dato-DXd TROPION-Lung01 efficacy in non-sq and sq NSCLC
Dato-DXd TROPION-Lung01 efficacy in non-sq and sq NSCLC ESMO 2023 Dato-DXd is potentially practice-changing in non-squamous 2L+ NSCLC PFS in Non-squamous (with and without AGAs) PFS in Squamous (with and without AGAs) PFS HR for non-squamous without AGAs: 0.71 (0.56, 0.91) ◼ Longer median PFS was ob
Slide 31: Dato-DXd TROPION-Lung01 Safety
Dato-DXd TROPION-Lung01 Safety ESMO 2023 Favorable tolerability against chemotherapy, careful monitoring is required for ILD management aInvestigator assessed. Dato-DXd: 2 cases of ILD/pneumonitis and 1 case of sepsis; aEvents included the selected PTs oral mucositis/stomatitis, oropharyngeal pain,
Slide 32: Dato-DXd TROPION-Lung05
Dato-DXd TROPION-Lung05 ESMO 2023 Encouraging antitumor activity was observed with Dato-DXd treatment in a heavily pretreated NSCLC population with AGAs Efficacy TROPION-Lung05 Study ◼ Phase 2, single-arm study evaluating Dato-DXd in patients with advanced or metastatic NSCLC with AGAs that progress
Slide 33: Dato-DXd TROPION-Lung04
Dato-DXd TROPION-Lung04 WCLC 2023 The interim analysis data demonstrated promising ORRs with durable responses in NSCLC for both the doublet and triplet combination Efficacy TROPION-Lung04 Study Cohort 2 (doublet), PD-L1 status Cohort 2 (doublet) 100 <1% (n=5) Ph1b study in NSCLC to investigate Dato
Slide 34: Dato-DXd TROPION-Breast01
Dato-DXd TROPION-Breast01 ESMO 2023 TROPION-Breast01 enables Dato-DXd to aim to set a new standard for TROP2 ADCs in HR+/HER2 low or negative BC TROPION-Breast01 Study Efficacy ◼ The dual primary endpoints are PFS and OS ◼ TLR was obtained in Sep 2023 ◼ 63% of the patients received 1L and 37% receiv
Slide 35: Dato-DXd BEGONIA Data Update
Dato-DXd BEGONIA Data Update ESMO 2023 Dato-DXd + durvalumab continues to demonstrate robust, durable responses in 1L TNBC in a biomarker-unselected population Efficacy (ORR) Efficacy (PFS) Confirmed ORR was 79% (49/62; 95% CI, 66.8–88.3) with 6 CR and 43 PR 1.0 Probability of progression-free survi
Slide 36: HER3-DXd HERTHENA-Lung01 study
HER3-DXd HERTHENA-Lung01 study WCLC 2023 HER3-DXd demonstrated clinically meaningful and durable efficacy in patients with EFGR-mutated NSCLC whose disease progressed after EGFR TKI and PBC Efficacy HERTHENA-Lung01 Study Registrational Ph2 study to evaluate antitumor activities of HER3-DXd in patien
Slide 37: DS-7300 Ph1/2 Study Data Update
DS-7300 Ph1/2 Study Data Update (I-DXd) WCLC 2023/ESMO 2023 DS-7300 continued to show durable efficacy in patients with heavily pretreated solid tumors, including SCLC, ESCC, mCRPC, and sqNSCLC Efficacy analysis in selected tumor types SCLC Dose level ESCC Dose level mCRPC* Dose level sqNSCLC Dose l
Slide 38: DS-6000 Ph1 Study OVC Cohort Data Update
DS-6000 Ph1 Study OVC Cohort Data Update (R-DXd) ESMO 2023 DS-6000 (CDH6 directed DXd-ADC) continues to demonstrate strong clinical activity in patients with platinum resistant ovarian cancer Efficacy * • Confirmed ORR: 46% in the 4.8–8.0 mg/kg OVC cohort (23/50; 95% CI: 32–61) • Median time to resp
Slide 39: External reputations to DXd-ADC technology
5DXd-ADCs External reputations to DXd-ADC technology Received the "Prime Minister's Award" at the 6th Japan Medical Research and Development Grand Prize. ◼ Developed the unique DXd-ADC technology to generate ENHERTU® ◼ The clinical development of multiple drug candidates applying this technology is
Slide 40: Next Wave Update
5DXd-ADCs Update Next Wave Update R&D day News Flow 40
Slide 41: Development status of COVID-19 vaccine DAICHIRONA
DAICHIRONA® (DS-5670) Development status of COVID-19 vaccine DAICHIRONA® for intramuscular injection* • Aug 2023: Approval obtained in Japan for booster vaccination of the original strain monovalent mRNA vaccine against COVID-19 • Sep 2023: Regulatory submission in Japan for booster vaccination of m
Slide 42: Next Wave Clinical and Regulatory Progress
Next Wave Clinical and Regulatory Progress VANFLYTA ® (quizartinib) (FLT3-ITD positive acute myeloid leukemia [AML], 1L) ◼ Sep 2023: Recommended for approval in EU by CHMP DS-3939 (TA-MUC1 directed ADC, Solid tumors) ◼ Sep 2023: Ph1/2 started DS-1471 (Anti-CD147 antibody, Solid tumors) ◼ Sep 2023: P
Slide 43: R&D Day
5DXd-ADCs Update Next Wave Update R&D day News Flow 43
Slide 44: R&D Day 2023
R&D Day 2023 Sunao Manabe Date and time Executive Chairperson and CEO Monday, December 11th, 2023 17:30-19:00 (EST) (Tue, Dec 12th 7:30-9:00 (JST)) Ken Takeshita Head of Global R&D Meeting style Mark Rutstein Virtual (Zoom) Head of Global Oncology Clinical Development 44
Slide 45: News Flow
5DXd-ADCs Update Next Wave Update R&D day News Flow 45
Slide 46: FY2023 News Flow
FY2023 News Flow As of Oct 2023 Planned major publications Planned regulator y submissions San Antonio Breast Cancer Symposium (SABCS, Dec 5-9, 2023) DESTINY-Lung05: HER2 mutant NSCLC, 2L+ • CN: FY2023 H2 DESTINY-Breast08: ENHERTU® ENHERTU® DESTINY-Gastric06: HER2 positive GC, 3L HER2 low BC, chemo
Slide 47: Agenda
Agenda 1 FY2023 Q2 Financial Results 2 Strategic Collaboration 3 FY2023 Forecast/ Annual Dividend 4 Business Update 5 R&D Update 6 Appendix 47
Slide 48: Major R&D Milestones (5DXd-ADCs 1)
Major R&D Milestones (5DXd-ADCs ①) Target Indication FY2023 As of Oct 2023 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 49: Major R&D Milestones (5DXd-ADCs 2)
Major R&D Milestones (5DXd-ADCs ②) As of Oct 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 obtained [Ph3, TROPION-Breast01] BC • TNBC, PD-1/PD-L1 inhibitor ineligible, 1L
Slide 50: Major R&D Milestones (Next Wave)
Major R&D Milestones (Next Wave) As of Oct 2023 FY2023 Project Target Indication [phase, study name] FY2024 H1 H2 VANFLYTA® • Approval anticipated • AML, 1L [Ph3, QuANTUM-First] • Approved (JP/US) (Quizartinib) (EU) EZHARMIA® • r/r PTCL [Registrational Ph2, VALENTINE-PTCL01] • TLR obtained DS-3939 •
Slide 51: Major R&D Pipeline: 5DXd-ADCs
Major R&D Pipeline: 5DXd-ADCs As of Oct, 2023 Phase 1 Phase 2 Phase 3 (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 1 DESTINY-Breast07 TROPION-PanTumor01 (durvalumab combo) TROPION-PanTumor03 adjuvant* BEGONIA DESTINY-Breast
Slide 52: Major R&D Pipeline: Next Wave
Major R&D Pipeline: Next Wave As of Oct 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 53: 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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