Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — Q2 FY2021 Earnings Presentation
43 slides from Daiichi Sankyo's earnings presentation, Oct 29, 2021
Slide 1: FY2021 Q2 Financial Results Presentation
FY2021 Q2 Financial Results Presentation DAIICHI SANKYO CO., LTD. Sunao Manabe President and CEO October 29, 2021 1
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 FY2021 Q2 Financial Results 2 FY2021 Forecast 3 Business Update 4 R&D Update 5 Appendix 3
Slide 4: Overview of FY2021 Q2 Results
Overview of FY2021 Q2 Results (Bn JPY) FY2020 Q2 YTD FY2021 Q2 YTD YoY Results Results Revenue 480.2 530.0 +10.4% 49.8 Cost of sales＊ 168.6 172.6 4.0 SG&A expenses＊ 148.6 165.7 17.1 R&D expenses＊ 104.6 109.0 4.4 Core operating profit＊ 58.4 82.7 +41.7% 24.3 Temporary income＊ 0.1 2.1 2.0 Temporary exp
Slide 5: Revenue
Revenue Increased by 49.8 Bn JPY (Increased by 37.7 Bn JPY excl. forex impact) (Bn JPY) Positive Factors Negative Factors FY2020 Results FY2020 Results 480.2 Japan Business Unit Japan Business Lixiana +6.6 Memary -11.0 (incl. Innovative Pharmaceuticals, Japan Business 0.0 5.2 Tarlige +5.0 Generic, V
Slide 6: Core Operating Profit
Core Operating Profit Increased by 24.3 Bn JPY (Increased by 19.7 Bn JPY excl. forex impact) (Bn JPY) Revenue +49.8 FY2020 Results FY2020 Results 58.4 incl. forex impact of +12.1 Cost of Sales +3.4 (Profit decreased) Revenue Revenue 0.0 49.8 Improvement in cost of sales ratio by change in product mi
Slide 7: Profit Attributable to Owners of the Company
Profit Attributable to Owners of the Company Increased by 10.8 Bn JPY (Bn JPY) Temporary Income/Expenses -2.0 (Profit increased) FY2020 Results FY2020 Results 51.7 FY2021: Gains related to sale of Osaka logistics center -2.1 Core Core Operating Financial Income/Expenses etc. +7.3 (Profit decreased）
Slide 8: Revenue: Business Units (incl. Forex Impact)
Revenue: Business Units (incl. Forex Impact) (Bn JPY) FY2020 Q2 YTD FY2021 Q2 YTD YoY Results Results Japan Business 250.1 255.6 +5.5 Daiichi Sankyo Healthcare 33.0 33.8 +0.8 Oncolgy Business 23.5 31.0 +7.5 Enhertu 11.3 22.4 +11.0 Turalio 0.8 1.3 +0.5 American Regent 58.9 77.0 +18.0 Injectafer 21.0
Slide 9: Revenue: Major Products in Japan
Revenue: Major Products in Japan (Bn JPY) FY2020 Q2 YTD FY2021 Q2 YTD YoY Results Results Lixiana anticoagulant 38.3 44.8 +6.6 Nexium ulcer treatment 39.0 39.6 +0.7 treatment for osteoporosis/ inhibitor of the progression of Pralia bone erosion associated with rheumatoid arthritis 17.0 18.4 +1.5 Tar
Slide 10: Agenda
Agenda 1 FY2021 Q2 Financial Results 2 FY2021 Forecast 3 Business Update 4 R&D Update 5 Appendix 10
Slide 11: Revision to the forecast
Revision to the forecast (Bn JPY) FY2021 FY2021 vs. Forecast Forecast Forecast as of Apr. (as of Apr.) (as of Oct.) Revenue 990.0 1,030.0 +40.0 Revenue - Increase factors Cost of sales* 320.0 330.0 +10.0 Sales expansion of main products (Lixiana, Injectafer, etc.), increase by SG&A expenses* 334.0 3
Slide 12: Agenda
Agenda 1 FY2021 Q2 Financial Results 2 FY2021 Forecast 3 Business Update 4 R&D Update 5 Appendix 12
Slide 13: ENHERTU: Performance in Each Region
ENHERTU®: Performance in Each Region ◆ Steady increase in product sales due to market penetration in launched countries ◆ Product sales: FY2021 Q2 YTD results 26.7 Bn JPY (YoY +14.4 Bn JPY) FY2021 forecast 62.7 Bn JPY (YoY +32.6 Bn JPY) US (HER2+ Breast Cancer 3L, HER2+ Gastric Cancer 2L) Europe (HE
Slide 14: LIXIANA: Growth in Each Country
LIXIANA®: Growth in Each Country Volume Global revenue FY2021 Q2 YTD results: 99.2 Bn JPY (YoY +20.1 Bn JPY) FY2021 forecast: 196.7 Bn JPY (YoY +30.7 Bn JPY) 40% 35.2% Japan 35% S. Korea 32.9% 30% 23.3% Taiwan 25% 23.2% Belgium 20% 19.0% Spain 18.3% Italy 15% 18.1% Germany 10% UK 14.2% 5% 6.7% Brazi
Slide 15: LIXIANA: Growth in Japan
LIXIANAⓇ: Growth in Japan Sales ◆ No.1 sales share (FY2021 Q2: 37.1%) ◆ Revenue FY2021 Q2 YTD results: 44.8 Bn JPY (YoY +6.6 Bn JPY), FY2021 forecast: 93.0 Bn JPY (YoY +15.6 Bn JPY) ◆ In August 2021, obtained approval in Japan for additional dosage and administration of “prevention of stroke and sys
Slide 16: Japan: Commercialization Collaboration of Migraine Treatment Drug
Japan: Commercialization Collaboration of Migraine Treatment Drug ◆ In August 2021, signed an agreement on commercialization collaboration with Eli Lilly Japan for migraine treatment drug lasmiditan succinate (US product name: REYVOW®) in Japan Product overview Agreement Overview ◆ Generic name: las
Slide 17: Agenda
Agenda 1 FY2021 Q2 Financial Results 2 FY2021 Forecast 3 Business Update 4 R&D Update 5 Appendix 17
Slide 18: ESMO 2021 Highlights / 3ADC Update / Alpha Update
ESMO 2021 Highlights 3ADC Update Alpha Update R&D Day News Flow 18
Slide 19: ESMO 2021 Highlights: Enhertu
ESMO 2021 Highlights: Enhertu® ◆ At this year’s ESMO, we reported unprecedented data that can change the treatment of breast cancer patients and further demonstrated the strength of our ADC technology across multiple cancers ➢ 4 late breaking presentations for Enhertu® and Dato-DXd ➢ 1st time to pre
Slide 20: ESMO 2021 Highlights: Enhertu
ESMO 2021 Highlights: Enhertu® ◆ Demonstrated transformative potential of Enhertu® across multiple HER2 targetable cancers such as NSCLC and gastric cancer as well as breast cancer DESTINY-Lung01 DESTINY-Gastric02 HER2 mutated NSCLC、2L、global Ph2 HER2 positive GC、2L、Western Ph2 aPrimary endpoint a3
Slide 21: ESMO 2021 Highlights: Dato-DXd, DS-7300
ESMO 2021 Highlights: Dato-DXd, DS-7300 Dato-DXd TROPION-PanTumor01 DS-7300 solid tumor Ph1/2 Subgroup analysis of NSCLC with AGAs Ph1 dose escalation interim analysis Data cutoff: April 6, 2021. ◆ DS-7300 showed promising early clinical activity in heavily pre-treated patients with several types of
Slide 22: ESMO 2021 Highlights / 3ADC Update / Alpha Update
ESMO 2021 Highlights 3ADC Update Alpha Update R&D Day News Flow 22
Slide 23: Enhertu: HER2 positive BC
Enhertu®：HER2 positive BC ◆ DESTINY-Breast03 (HER2+, 2L, Ph3) ➢ Aug 2021: Data obtained Granted for Real Time Oncology Review* (RTOR) by FDA ➢ Sep 2021: Data presented at ESMO Granted Breakthrough Therapy Designation by FDA ➢ FY2021 Q3: Filing planned to the Health Authorities ◆ Significantly increa
Slide 24: Enhertu: GC, NSCLC, and others
Enhertu®: GC, NSCLC, and others HER2 positive GC HER2 mutated NSCLC ◆ DESTINY-Gastric01 (3L, Ph2, JP & KR), ◆ Advanced/Metastatic 2L+ ➢ BTD granted by FDA DESTINY-Gastric02 (2L, Ph2, West) ➢ DESTINY-Lung01 (2L, Ph2) data presented at Filing planned in FY2021 Q3 in Europe ESMO 2021 ◆ DESTINY-Gastric0
Slide 25: Dato-DXd: NSCLC
Dato-DXd: NSCLC ◆ Clinical trial collaboration for TROPION-Lung08 study has been entered with Merck in Sep 2021. ➢ 1st line NSCLC patients without actionable genomic alterations and high PD-L1 expression will be enrolled in the study. ➢ Current SOC for this patient population is immunotherapy with o
Slide 26: ESMO 2021 Highlights / 3ADC Update / Alpha Update
ESMO 2021 Highlights 3ADC Update Alpha Update R&D Day News Flow 26
Slide 27: Daiichi Sankyo DXd-ADC Franchise
Daiichi Sankyo DXd-ADC Franchise Project Pre- Target indications Discovery Ph1 Ph2 Ph3 Filed Launched (Target) Clinical EnhertuⓇ Breast, Gastric, 1 (HER2) NSCLC, CRC, etc. Dato-DXd NSCLC, Breast, 2 (TROP2) etc. HER3-DXd NSCLC, CRC, 3 (HER3) Breast DS-7300 ESCC, CRPC, SCLC, 4 (B7-H3) etc. DS-6157 5 G
Slide 28: DS-6157: GPR20 Directed ADC
DS-6157：GPR20 Directed ADC Target antigen: GPR20 Ph1 study ◆ Orphan G Protein-Coupled Receptor (GPCR） Ph1 study design ◆ Highly expressed specifically in GIST Dose escalation Dose expansion ◆ Interstitial cells of Cajal, the cell origin of GIST, are the only GPR20+ cells ◆ Function in GIST is unknow
Slide 29: Characteristics of DS-5670 (COVID-19 mRNA vaccine): antigen design
Characteristics of DS-5670 (COVID-19 mRNA vaccine): antigen design DS-5670 targets Receptor Binding Domain (RBD) instead of full spike protein of SARS-CoV-2 Full length of spike protein (S-Full) Receptor binding domain (RBD) RBD ◆ Length of mRNA ◆ Length of mRNA ➢ 4.1 kb ➢ 1.0 kb ◆ Proposed advantag
Slide 30: Superiority of RBD antigen to S-Full antigen
Superiority of RBD antigen to S-Full antigen ◆ Binding of RBD to ACE2 is cis- regulated by domains other than RBD, so-called ‘hip’, ’knee’, and ‘ankle’ RBD ◆ When using the S-Full of variants as vaccine antigen: ➢ Mutations in ‘hip’, ’knee’, and ‘ankle’ may affect the immunogenicity of RBD (may be h
Slide 31: Neutralization Activity
DS-5670: Cross-neutralizing activity against recently emerged variants • Cynomolgus monkey • 50 μg/body of DS-5670 by mRNA conversion • Dosed in brachial deltoid muscle q2w, total 3 times (4 monkeys/group) • Measured neutralizing activity using plasma collected 2 weeks after the third dose (AMED Kaw
Slide 32: DS-5670: Ph1/2 study
DS-5670：Ph1/2 study Ph1/2 study design Ph1/2 study results ◆ Initiated the study in March 2021 and Japanese healthy DS-5670 obtained TLR in October 2021 adults & elderly Randomized subjects ➢ For the 142 subjects who completed two Placebo injections, no critical safety issues were ◆ Objective: asses
Slide 33: DS-5670: Future development plan
DS-5670：Future development plan ◆ Planning to initiate Ph2 study in November this year to determine the dose ✓ The objective of the study is to confirm safety and determine the dose for Ph3 study using the clinical trial material which manufacturing process was optimized to ensure stable quality ◆ P
Slide 34: ESMO 2021 Highlights / 3ADC Update / Alpha Update
ESMO 2021 Highlights 3ADC Update Alpha Update R&D Day News Flow 34
Slide 35: R&D Day 2021
R&D Day 2021 Sunao Manabe Ken Takeshita President and CEO Global R&D Head The event will be held once on the following date Date and time ➢ Dec 14 (Tue) 17:30-19:00 EST, Dec 15 (Wed) 7:30-9:00 JST Meeting style Virtual, teleconference 35
Slide 36: ESMO 2021 Highlights / 3ADC Update / Alpha Update
ESMO 2021 Highlights 3ADC Update Alpha Update R&D Day News Flow 36
Slide 37: FY2021 News Flow
FY2021 News Flow As of Oct 2021 Planned publications Key data readouts DESTINY-Breast04: HER2 low BC, post chemo, Ph3 SABCS (Dec 7-10) Enhertu® • FY2021 Q4 Dato-DXd TROPION-PanTumor01 TNBC cohort data QuANTUM-First: AML, 1L, Ph3 Quizartinib • FY2021 Q3 ASH (Dec 11-14) DS-3201 ATL/L Ph2 data Planned
Slide 38: Agenda
Agenda 1 FY2021 Q2 Financial Results 2 FY2021 Forecast 3 Business Update 4 R&D Update 5 Appendix 38
Slide 39: Major R&D Milestones in FY2021 (3ADCs)
Major R&D Milestones in FY2021 (3ADCs) As of Oct 2021 FY2021 Project Target Indications [phase, study name] Q1 Q2 Q3 Q4 Submission HER2+, 2L [P3, DESTINY-Breast03] TLR obtained anticipated BC HER2 low, post chemo [P3, DESTINY-Breast04] TLR anticipated HER2+, 1L [P3, DESTINY-Breast09] Study started S
Slide 40: Major R&D Milestones in FY2021 (Alpha)
Major R&D Milestones in FY2021 (Alpha) As of Oct 2021 FY2021 Project Target Indications [phase, study name, region] Q1 Q2 Q3 Q4 Quizartinib AML, 1L [P3, JP/US/EU/Asia] TLR anticipated Pexidartinib Tenosynovial giant cell tumor [P2, JP] Study started Teserpaturev/G47Δ Malignant glioma [IIS, JP] Appro
Slide 41: Major R&D Pipeline: 3ADCs
Major R&D Pipeline: 3ADCs As of Oct 2021 Phase 1 Phase 2 Phase 3 Submitted (JP/US) NSCLC, TNBC, HR+ BC (US/EU/Asia) HER2+ BC 2L~/1L (US/EU/Asia) TNBC (JP/US/EU/Asia)HER2+ BC 3L TROPION-PanTumor01 DESTINY-Breast07 (durvalumab combo) DESTINY-Breast02 BEGONIA (JP/US/EU/Asia) NSCLC (US/EU/Asia) HER2 low
Slide 42: Major R&D Pipeline: Alpha
Major R&D Pipeline: Alpha As of Oct 2021 Phase 1 Phase 2 Phase 3 Submitted DS-7300 (JP/US) DS-3201 (JP/US) DS-3201 (JP) Quizartinib (JP/US/EU/Asia) Tarlige (JP) B7-H3-directed ADC EZH1/2 inhibitor EZH1/2 inhibitor FLT3 inhibitor α2δ Ligands ESCC, CRPC, SCLC, etc. Non-Hodgkin‘s lymphomas ATL/L 1L AML
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 43
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