Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — Daiichi Sankyo Co Ltd Ord — Q3 2023 Earnings Presentation
44 slides from Daiichi Sankyo's earnings presentation, Jan 31, 2024
Slide 1: FY2023 Q3 Financial Results Presentation
FY2023 Q3 Financial Results Presentation DAIICHI SANKYO CO., LTD. Koji Ogawa Executive Officer, CFO January 31, 2024
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 Q3 Financial Results 2 FY2023 Forecast/ Annual Dividend 3 Business Update 4 R&D Update 5 Appendix 3
Slide 4: Overview of FY2023 Q3 Results
Overview of FY2023 Q3 Results (Bn JPY) FY2022 Q3 YTD FY2023 Q3 YTD YoY Results Results Revenue 948.3 1,173.3 +23.7% 225.0 Cost of sales * 257.4 310.3 52.9 SG&A expenses * 330.8 433.9 103.1 R&D expenses * 241.7 256.8 15.1 Core operating profit * 118.3 172.2 +45.5% 53.9 Temporary income * 11.0 26.9 15
Slide 5: Revenue
Revenue Increased by 225.0 Bn JPY (Increased by 185.0 Bn JPY excl. forex impact) (Bn JPY) Positive Factors Negative Factors FY2022 Q3 YTD FY2022 Results Q3 YTD Results 948.3 Japan Business Unit Inavir +13.8 Japan Business Lixiana +10.0 (incl. Innovative Pharmaceuticals, Japan Business 0.0 57.9 Enher
Slide 6: Core Operating Profit
Core Operating Profit Increased by 53.9 Bn JPY (Increased by 48.6 Bn JPY excl. forex impact) (Bn JPY) Revenue +225.0 incl. forex impact of +40.0 FY2022 Q3 YTD FY2022 Q3 YTD Results Results 118.3 Cost of Sales +44.0 Increase in cost of sales due to the revenue increase Revenue Revenue 225.0 SG&A Expe
Slide 7: Profit Attributable to Owners of the Company
Profit Attributable to Owners of the Company Increased by 76.9 Bn JPY (Bn JPY) Temporary Income/Expenses +13.5 (Profit Increased) FY2022 Q3 FY2023 Q3 YoY YTD Results YTD Results FY2022 Q3 YTD Temporary Income 11.0*1 26.9*2 +15.8 FY2022 Q3 YTD Results Results 86.7 Temporary Expenses 2.2 4.6 +2.3 Core
Slide 8: Revenue: Business Units (incl. Forex Impact)
Revenue: Business Units (incl. Forex Impact) (Bn JPY) FY2022 Q3 YTD FY2023 Q3 YTD YoY Results Results Japan Business 356.4 412.3 +55.9 Daiichi Sankyo Healthcare 54.8 59.9 +5.1 Oncolgy Business 124.7 233.0 +108.2 Enhertu 122.1 227.5 +105.4 Turalio 2.7 4.1 +1.4 American Regent 143.5 152.0 +8.5 Injecta
Slide 9: Revenue: Major Products in Japan
Revenue: Major Products in Japan (Bn JPY) FY2022 Q3 YTD FY2023 Q3 YTD YoY Results Results Lixiana anticoagulant 79.5 89.5 +10.0 treatment for osteoporosis/ inhibitor of the progression of Pralia bone erosion associated with rheumatoid arthritis 30.4 33.3 +2.9 Tarlige pain treatment 29.1 35.4 +6.3 Vi
Slide 10: Agenda
Agenda 1 FY2023 Q3 Financial Results 2 FY2023 Forecast/ Annual Dividend 3 Business Update 4 R&D Update 5 Appendix 10
Slide 11: Revision to the forecast
Revision to the forecast (Bn JPY) FY2023 FY2023 Revenue vs. Forecast Forecast Forecast : Increase by forex impact, sales increase of Inavir®due to outbreak of as of Oct. (As of Oct.) (As of Jan.) influenza, sales increase due to supply of Daichirona®, etc. Revenue 1,550.0 1,580.0 +30.0 Cost of sales
Slide 12: Revision of Annual Dividend
Revision of Annual Dividend Increase FY2023 annual dividend forecast per share to 50 JPY (Increase by 10 JPY compared to forecast as of October 2023; by 20 JPY compared to FY2022) ◆ FY2023 Annual Dividend Forecast Annual Dividend per share ➢ Forecast as of April 2023 As of Jan. 2024 Increase by 4 JP
Slide 13: Agenda
Agenda 1 FY2023 Q3 Financial Results 2 FY2023 Forecast/ Annual Dividend 3 Business Update 4 R&D Update 5 Appendix 13
Slide 14: ENHERTU Revenue
ENHERTU® Revenue (Bn JPY) FY2023 Q3 YTD Results FY2023 Forecast <Reference> Total vs. Forecast YoY Consideration as of Oct. Product Sales 276.0 136.3 383.9 2.2 - Japan 17.7 9.2 22.8 1.3 - US 162.8 63.0 226.3 -3.2 - Europe 64.7 42.4 94.5 1.7 - ASCA 30.8 21.6 40.3 2.4 - 10.1 * 1 7.6 * 1 Upfront paymen
Slide 15: ENHERTU Performance in Each Region (US, EU)
ENHERTU® Performance in Each Region (US, EU) Global product sales: FY2023Q3 YTD results 276.0 Bn JPY（YoY +136.3 Bn JPY）FY2023 forecast 383.9 Bn JPY（vs. Forecast as of Oct. +2.2 Bn JPY） US ◆ Product sales: FY2023Q3 YTD results 162.8 Bn JPY (1,136 Mn USD) FY2023 forecast 226.3 Bn JPY (1,575 Mn USD) ◆
Slide 16: ENHERTU Performance in Each Region (Japan, ASCA)
ENHERTU® Performance in Each Region (Japan, ASCA) Global product sales: FY2023Q3 YTD results 276.0 Bn JPY（YoY +136.3 Bn JPY）FY2023 forecast 383.9 Bn JPY（vs. Forecast as of Oct. +2.2 Bn JPY） Japan ◆ Product sales: FY2023Q3 YTD results 17.7 Bn JPY FY2023 forecast 22.8 Bn JPY ◆ Indication: HER2+ mBC 2L
Slide 17: Major Updates on Patent Disputes
Major Updates on Patent Disputes Dispute with Novartis regarding Plexxikon's Patents ◆ Dec. 2023 Our U.S. subsidiary Plexxikon settled with Novartis ➢ Plexxikon received a lump sum payment of 182 Mn USD (26.1 Bn JPY) and the settlement resulted in the dismissal of Novartis’s appeal ➢ The payment is
Slide 18: Major Updates on Patent Disputes
Major Updates on Patent Disputes Dispute with Seagen (SGN) regarding Daiichi Sankyo ADC ➁ (Disputes regarding SGN’s patent) ◆ Nov. 2023 DS filed a notice of appeal to the U.S. Court of Appeals for the Federal Circuit seeking review of the amended final judgment by the U.S. District Court for the Eas
Slide 19: Other Regional Initiatives
Other Regional Initiatives Japan ◆ DAICHIRONA®FOR INTRAMUSCULAR INJECTION COVID-19 vaccine ➢ Dec. 2023 Supply Omicron XBB.1.5-adapted monovalent vaccine Europe ◆ Update on Collaboration with Esperion Therapeutics, Inc ➢ Jan. 2024 DSE and Esperion amended their collaboration as below • for Esperion t
Slide 20: Meeting Information
Meeting Information ESG Meeting ◆ Date and time: Thursday, February 29, 2024 16:00-17:30 (JST) ◆ Speaker: Kama Chairperson of the Board, Manabe CEO, Okuzawa COO, Fukuoka CStO*1, Ogawa CFO, Matsumoto CHRO*2 and others *1 Chief Strategy Officer、*2 Chief Human Resources Officer ◆ Meeting style: on site
Slide 21: Agenda
Agenda 1 FY2023 Q3 Financial Results 2 FY2023 Forecast/ Annual Dividend 3 Business Update 4 R&D Update 5 Appendix 21
Slide 22: 5DXd ADCs Update
5DXd ADCs Update Next Wave Update News Flow 22
Slide 23: ENHERTU DESTINY-PanTumor02 study
ENHERTU® DESTINY-PanTumor02 study Filing accepted with priority review in US in Jan 2024 for a tumor agnostic therapy in previously treated patients with HER2 expressing solid tumors ORR DESTINY-PanTumor02 study An open-label, multicenter study, in HER2-expressing advanced solid tumors not eligible
Slide 24: Dato-DXd TROPION-Breast04 study
Dato-DXd TROPION-Breast04 study Started new Ph3 study for neoadjuvant and adjuvant therapy of TNBC or HR-low, HER2-low or negative BC in Nov 2023 TROPION-Breast04 study design Neoadjuvant Surgery Adjuvant Dato-DXd + Durvalumab Durvalumab x 9 cycles Key Eligibility Criteria Q3W x 8 +/- Chemotherapy ◆
Slide 25: Dato-DXd TROPION-Breast05 study
Dato-DXd TROPION-Breast05 study Started Ph3 combination study with durvalumab for PD-L1 positive metastatic TNBC 1L in Nov 2023 TROPION-Breast05 study design Dato-DXd + Durvalumab (N=275) Key Eligibility Criteria Chemotherapy ◆ Previously untreated metastatic or locally advanced inoperable TNBC R +
Slide 26: HER3-DXd HERTHENA-Lung01 study
HER3-DXd HERTHENA-Lung01 study Filing accepted with priority review in US for the treatment of patients with EGFR mutated NSCLC 3L, as a potential first HER3-targeted drug HERTHENA-Lung01 study HER3-DXd NSCLC Registrational Ph2 study to evaluate antitumor Advanced/metastatic Advanced/metastatic Adva
Slide 27: HER3-DXd HERTHENA-PanTumor01 study
HER3-DXd HERTHENA-PanTumor01 study Seeking to expand to new tumor types HERTHENA-PanTumor01 study design Melanoma (N=40) HERTHENA-PanTumor01 study HER3- Ph2 study in patients with locally advanced or metastatic DXd SCCHN solid tumors ◼ Patients who have received 1 or more prior lines of 5.6mg/kg (N=
Slide 28: I-DXd IDeate-Lung02 study
I-DXd* IDeate-Lung02 study** SCLC 2L+ Ph3 study Plan to start a pivotal study based on the promising data in SCLC patients in FY2024 H1 IDeate-Lung02 Study Design I-DXd 12 mg/kg Q3W R 1:1 TPC IDeate-Lung02 N=468 Topotecan, Amrubicin, Lurbinectedin IDeate-Lung02 Study Primary Endpoint: ORR by BICR, O
Slide 29: DS-6000 REJOICE-Ovarian01 study
DS-6000 (R-DXd) REJOICE-Ovarian01 study Based on promising Ph1 data, planning to initiate Ph2/3 for platinum-resistant ovarian cancer in FY2023 Q4 REJOICE-Ovarian01 study design (N=650) Ph2 part Ph3 part Recommended Ph3 dose DS-6000 4.8mg/kg, Q3W DS-6000 Population RP3D, Q3W • Platinum-resistant ova
Slide 30: Other clinical progresses and regulatory updates
5DXd ADCs Other clinical progresses and regulatory updates ENHERTU® ◼ Dec 2023: Filing accepted in China for HER2 positive locally advanced or metastatic gastric or GEJ adenocarcinoma 3L based on DESTINY-Gastric06 study data Dato-DXd ◼ FY2023 Q4: Expected to obtain a filing acceptance in US based on
Slide 31: Next Wave Update
5DXd ADCs Update Next Wave Update News Flow 31
Slide 32: Valemetostat VALENTINE-PTCL01 Primary Results
Valemetostat VALENTINE-PTCL01 Primary Results ASH 2023 Valemetostat monotherapy provided a clinically meaningful benefit for patients with R/R PTCL VALENTINE-PTCL01 Efficacy A Ph2 single-arm study in R/R PTCL (N=133) CT-based BICR assessment CT-based response assessment treated with 200 mg/day valem
Slide 33: DAICHIRONA Approval of COVID-19 vaccine
DAICHIRONA® (DS-5670) Approval of COVID-19 vaccine DAICHIRONA® FOR INTRAMUSCULAR INJECTION* ◆DS original cationic lipid is applied ➢ Best lipid and lipid composition ratio are selected based on efficacy & safety perspectives ◆The first mRNA vaccine made in Japan ◆COVID-19 vaccine for Omicron XBB.1.5
Slide 34: DS-2325 Ph1b/2 study start
DS-2325 （KLK5 inhibitor） Ph1b/2 study start 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 births Curr
Slide 35: News Flow
5DXd ADCs Update Next Wave Update News Flow 35
Slide 36: FY2023, FY2024 News Flow
FY2023, FY2024 News Flow As of Jan 2024 Regulator y decisions Key data readouts DESTINY-PanTumor02, DESTINY-CRC02, etc.: DESTINY-Breast06*: HER2 IHC3+ solid tumors ENHERTU® HR+ and HER2 low BC, chemo naïve, Ph3 ENHERTU® • US: FY2024 H1 • FY2024 H1 DESTINY-Gastric06: HER2+ GC, 3L+ • CN: FY2024 H1 HER
Slide 37: Agenda
Agenda 1 FY2023 Q3 Financial Results 2 FY2023 Forecast/ Annual Dividend 3 Business Update 4 R&D Update 5 Appendix 37
Slide 38: Major R&D Milestones (ENHERTU)
Major R&D Milestones (ENHERTU®) As of Jan 2024 Target Indication FY2023 Project FY2024 [phase, study name] H1 H2 • HR+/HER2 low, chemo naive • TLR anticipated [Ph3, DESTINY-Breast06] BC • HER2+, 1L [Ph3, DESTINY-Breast09] • TLR anticipated • HER2+, neoadjuvant • TLR anticipated ENHERTU® [Ph3, DESTIN
Slide 39: Major R&D Milestones (Dato-DXd)
Major R&D Milestones (Dato-DXd) As of Jan 2024 Target Indication FY2023 Project FY2024 [phase, study name] H1 H2 • Planned regulatory NSCLC • 2/3L [Ph3, TROPION-Lung01] • TLR obtained filing※ (US) • HR+ and HER2 low or negative, 2/3L • Planned regulatory • TLR obtained [Ph3, TROPION-Breast01] filing
Slide 40: Major R&D Milestones (HER3-DXd, I-DXd, DS-6000)
Major R&D Milestones (HER3-DXd, I-DXd, DS-6000) As of Jan 2024 Target Indication FY2023 Project FY2024 [phase, study name] H1 H2 • EGFR mutated, 3L • Regulatory decision • Filed (US) [Ph2, HERTHENA-Lung01] anticipated (US) NSCLC • EGFR mutated, 2L • TLR anticipated HER3-DXd [Ph3, HERTHENA-Lung02] •
Slide 41: Major R&D Milestones (Next Wave)
Major R&D Milestones (Next Wave) As of Jan 2024 FY2023 Project Target Indication [phase, study name] FY2024 H1 H2 • Planned regulatory • Regulatory decision EZHARMIA® • r/r PTCL [Registrational Ph2, VALENTINE-PTCL01] • TLR obtained filing※ (JP) anticipated (JP) DS-2325 • Netherton syndrome [Ph1b/2]
Slide 42: Major R&D Pipeline: 5DXd ADCs
Major R&D Pipeline: 5DXd ADCs As of Jan 2024 Phase 1 Phase 2 Phase 3 (US/EU/Asia) HER2+ BC 2L+/1L (CN) NSCLC, TNBC (US/EU/Asia) TNBC (JP/US/EU/Asia) EGFR mutated (JP/US/EU/Asia) HER2+ BC (JP/US/EU/Asia) TNBC neoadjuvant and DESTINY-Breast07 TROPION-PanTumor02 (durvalumab combo) NSCLC (osimertinib co
Slide 43: Major R&D Pipeline: Next Wave
Major R&D Pipeline: Next Wave As of Jan 2024 Phase 1 Phase 2 Phase 3 Regulatory phase DS-1055 (JP/US) DS-7011 (US) Valemetostat (DS-3201) (EU) Pexidartinib (JP/Asia) Valemetostat (DS-3201) (JP/US/EU/Asia) Anti-GARP antibody Anti-TLR7 antibody EZH1/2 inhibitor CSF-1/KIT/FLT3 inhibitor EZH1/2 inhibito
Slide 44: 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 44
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