Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — Daiichi Sankyo Co Ltd Ord — Q3 2024 Earnings Presentation
44 slides from Daiichi Sankyo's earnings presentation, Jan 31, 2025
Slide 1: FY2024 Q3 Financial Results Presentation
FY2024 Q3 Financial Results Presentation DAIICHI SANKYO CO., LTD. Koji Ogawa Executive Officer, CFO January 31, 2025
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 FY2024 Q3 Financial Results 2 FY2024 Forecast 3 Business Update 4 R&D Update 5 Appendix 3
Slide 4: Overview of FY2024 Q3 Results
Overview of FY2024 Q3 Results (Bn JPY) FY2023 Q3 YTD FY2024 Q3 YTD YoY Results Results Revenue 1,173.3 1,367.6 +16.6% 194.3 Cost of sales *1 310.3 321.4 11.1 SG&A expenses *1 433.9 516.6 82.7 DXd ADC profit share *2 119.1 168.5 49.4 Other SG&A expenses 314.8 348.2 33.3 R&D expenses *1 256.8 300.6 43
Slide 5: Revenue
Revenue Increased by 194.3 Bn JPY (Increased by 148.6 Bn JPY excl. forex impact) (Bn JPY) Positive Factors Negative Factors FY2023 Q3 FY2023 YTD Results Q3 Results 1,173.3 Japan Business Unit Lixiana +13.7 Daiichi Sankyo -64.9 Japan Business Tarlige +7.6 Espha (incl. Innovative Pharmaceuticals, Japa
Slide 6: Core Operating Profit
Core Operating Profit Increased by 56.8 Bn JPY (Increased by 57.7 Bn JPY excl. forex impact) (Bn JPY) Revenue +194.3 incl. forex impact of +39.6 FY2023 Q3 YTD FY2023 Q3 Results Results 172.2 Cost of Sales -0.1 Revenue Improvement in cost of sales ratio by change in product mix Revenue 194.3 SG&A Exp
Slide 7: Profit Attributable to Owners of the Company
Profit Attributable to Owners of the Company Increased by 45.0 Bn JPY (Bn JPY) Temporary Income/Expenses -3.0 (Profit Decreased) FY2023 Q3 FY2024 Q3 YoY YTD Results YTD Results FY2023 Q3 YTD Temporary Income 26.9*1 21.5*2 -5.4 FY2023 Q3 Results Results 163.6 Temporary Expenses 4.6 2.2 -2.4 Core Core
Slide 8: Agenda
Agenda 1 FY2024 Q3 Financial Results 2 FY2024 Forecast 3 Business Update 4 R&D Update 5 Appendix 8
Slide 9: Revision to the forecast
Revision to the forecast (Bn JPY) FY2024 FY2024 Forecast Forecast vs. Forecast (As of Oct.) (As of Jan.) Revenue 1,830.0 1,830.0 - Revenue Cost of sales *1 410.0 410.0 - : Sales expansion of mainstay products including Enhertu, etc. SG&A expenses 700.0 700.0 - ：Delays in approval and launch of Datro
Slide 10: Agenda
Agenda 1 FY2024 Q3 Financial Results 2 FY2024 Forecast 3 Business Update 4 R&D Update 5 Appendix 10
Slide 11: ENHERTU Performance
ENHERTU® Performance Global Product Sales Q3 YTD Product Sales Result 404.4Bn JPY (YoY +128.4Bn JPY) FY2024 Forecast 539.9Bn JPY (vs Oct Forecast +16.9Bn JPY) ◆ Key Growth Factors (YoY YTD Results) and Key Updates + 47% Achieved double-digit growth rate in all regions leading by HER2+ BC 2L and HER2
Slide 12: DATROWAY Approved in Japan and the US
DATROWAY® (Dato-DXd) Approved in Japan and the US DATROWAY® (anti-TROP2 ADC) approved in Japan and the US - Second product approved on our DXd ADC platform after ENHERTU® ◆ Approval acquisition date ➢ Japan : December 2024 ➢ US : January 2025 ◆ Indication Unresectable or metastatic, hormone receptor
Slide 13: DS-3939 Acquisition of Intellectual Property Rights for Anti-TA-MUC1 Antibody
DS-3939 Acquisition of Intellectual Property Rights for Anti-TA-MUC1 Antibody In Dec. 2024, acquired the intellectual property rights for gatipotuzumab (anti-TA-MUC1 antibody) from Glycotope* ◆ Anti-TA-MUC1** antibody ➢ Antibody of our sixth DXd ADC, DS-3939, currently under development by Daiichi S
Slide 14: Information: Oncology Business Briefing
Information: Oncology Business Briefing Oncology Business Briefing ◆ Time & Date : Wednesday, February 26, 2025, 7:30 - 9:00 AM (JST) (Tuesday, February 25, 5:30 - 7:00 PM (EST)) ◆ Speakers: Sunao Manabe Executive Chairperson & CEO Ken Keller Head of Oncology Business Unit Dan Switzer Head of US Onc
Slide 15: Agenda
Agenda 1 FY2024 Q3 Financial Results 2 FY2024 Forecast 3 Business Update 4 R&D Update 5 Appendix 15
Slide 16: 5DXd ADCs Update
5DXd ADCs Update Next Wave Update News Flow 16
Slide 17: ENHERTU Approval of New Indication for Breast Cancer
ENHERTU® Approval of New Indication for Breast Cancer DESTINY-Breast06 DESTINY-Breast06 brings ENHERTU® benefit earlier and broader ◼ Approved in the US for the treatment of patients with HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) BC, who progressed on one or mo
Slide 18: ENHERTU 1L Treatment for HER2+ Gastric Cancer
ENHERTU® 1L Treatment for HER2+ Gastric Cancer DESTINY-Gastric05 Ph3 Expand into earlier treatment lines by combining with current SOC to maximize patient outcomes DESTINY-Gastric05 Study Design Main Cohort Eligible patient PD-L1 CPS≥1 Arm M1 ENHERTU® + 5-FU or capecitabine + • Locally advanced or m
Slide 19: DATROWAY Breast Update: First approval
DATROWAY® Breast Update: First approval of DATROWAY® (Dato-DXd) TROPION-Breast01 Ph3 Approved for HR+/HER2- metastatic BC as the first indication in the US and Japan TROPION-Breast01 Study ✓ Inoperable or metastatic HR positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previ
Slide 20: DATROWAY Lung Update
DATROWAY® Lung Update (Dato-DXd) Regulatory Status in the US and EU Target indication changed from NSQ NSCLC to EGFR mutated NSCLC in the US US ◼ Nov 2024: Application for 2/3L NSQ NSCLC based on TROPION-Lung01 withdrawn ◼ Nov 2024: New application* submitted for accelerated approval for the treatme
Slide 21: DATROWAY Pooled Analysis of TROPION-Lung05 and TROPION-Lung01
DATROWAY® Pooled Analysis of TROPION-Lung05 and TROPION-Lung01 (Dato-DXd) ESMO Asia 2024 DATROWAY® is a potential treatment option for patients with EGFRm NSCLC in the 2L and later settings Efficacy ◼ DATROWAY® demonstrated robust PFS and OS in the EGFRm Pool clinical activity in patients with EGFRm
Slide 22: HER3-DXd Investigating Optimal Treatment Sequence of DXd ADCs
HER3-DXd Investigating Optimal Treatment Sequence of DXd ADCs HERTHENA-Breast01 Ph1b/2 Ph1b/2 dose-finding combination study for post ENHERTU® progression in HER2+ unresectable locally advanced BC or mBC HERTHENA-Breast01 Study Design HER3-DXd + Eligible patient Dose finding pertuzumab+trastuzumab S
Slide 23: I-DXd Expand Target Indications to ESCC
I-DXd Expand Target Indications to ESCC IDeate-Esophageal01 Ph3 New Ph3 study of I-DXd in pretreated advanced or metastatic esophageal squamous cell carcinoma (ESCC) IDeate-Esophageal01 Study Design I-DXd Eligible patient 12.0 mg/kg, q3w • Unresectable advanced or metastatic ESCC • Progression after
Slide 24: R-DXd Investigate Possibilities beyond Platinum-Resistant Ovarian Cancer
Investigate Possibilities beyond Platinum-Resistant R-DXd Ovarian Cancer REJOICE-PanTumor01 Ph2 Initiated a signal-seeking study in solid tumors with various CDH6 expression levels REJOICE-PanTumor01 Study Design Eligible patient Endometrial cancer • Locally advanced or metastatic solid Endpoints Ce
Slide 25: 5DXd ADCs Other Clinical Updates
5DXd ADCs Other Clinical Updates ENHERTU ® ◼ Plan to develop ENHERTU® subcutaneous injection in collaboration with Alteogen Inc., Korea DATROWAY ® ◼ Jan 2025: TROPION-Lung12 Ph3 combination study with rilvegostomig for adjuvant therapy in NSCLC with ctDNA-positive or at least one high-risk pathologi
Slide 26: Next Wave Update
5DXd ADCs Update Next Wave Update News Flow 26
Slide 27: VANFLYTA QuANTUM-Wild Study Design
VANFLYTA® QuANTUM-Wild Study Design Started QuANTUM-Wild Ph3 study for FLT3-ITD negative AML based on data from QUIWI study QuANTUM-Wild Study Design Consolidation Maintenance 28-day cycle Induction (up to 2 cycles) (up to 4 cycles) (up to 36 cycles) Eligible patients Arm A: High dose cytarabine + •
Slide 28: EZHARMIA IO Combination for NSCLC
EZHARMIA® IO Combination for NSCLC Ph1b/2 signal seeking combination study with pembrolizumab in NSCLC 1L Ph1b/2 Study Design Ph1b Ph2 dose escalation Eligible patients EZHARMIA® • PD-L1 TPS ≥ 50% IHC + pembrolizumab • Non-AGA • Unresectable or metastatic NSCLC EZHARMIA® R + pembrolizumab 1:1 • Anti
Slide 29: DS-2243 Plan to Start a Clinical Study for New T-cell Engager
DS-2243 Plan to Start a Clinical Study for New T-cell Engager A Potential First-in-Class Bispecific T-cell Engager (Bi-TCE) Targeting HLA-A*02/NY-ESO Tumors Mode of Action ◼ Cutting-Edge Bi-TCE: Engineered to selectively engage both tumor antigens and T-cells, driving a targeted and potent immune re
Slide 30: News Flow
5DXd ADCs Update Next Wave Update News Flow 30
Slide 31: FY2024 and FY2025 News Flow
FY2024 and FY2025 News Flow As of Jan 2025 Planned major data disclosures Key data readouts ESMO Virtual (Feb 12, 2025 at 18:30 CET) DESTINY-Breast11*: HER2+ BC, neoadjuvant, Ph3 • FY2025 H1 TROPION-Breast01: DATROWAY® HR+/HER2 low BC, 2/3L, Ph3 DESTINY-Breast05*: HER2+ BC, Adjuvant, Ph3 • Final OS
Slide 32: Agenda
Agenda 1 FY2024 Q3 Financial Results 2 FY2024 Forecast 3 Business Update 4 R&D Update 5 Appendix 32
Slide 33: Revenue: Business Units (incl. Forex Impact)
Revenue: Business Units (incl. Forex Impact) (Bn JPY) FY2023 Q3 YTD FY2024 Q3 YTD YoY Results Results Japan Business 412.3 385.7 -26.6 Daiichi Sankyo Healthcare 59.9 67.4 +7.5 Oncolgy Business 233.0 337.2 +104.2 Enhertu 227.5 329.1 +101.6 Turalio 4.1 5.1 +1.0 Vanflyta 1.3 2.9 +1.6 American Regent 15
Slide 34: Revenue: Major Products in Japan
Revenue: Major Products in Japan (Bn JPY) FY2023 Q3 YTD FY2024 Q3 YTD YoY Results Results Lixiana anticoagulant 89.5 103.2 +13.7 Tarlige pain treatment 35.4 42.9 +7.6 Treatment for osteoporosis/ inhibitor of the progression of Pralia bone erosion associated with rheumatoid arthritis 33.3 32.7 -0.6 V
Slide 35: 5DXd ADCs Revenue (incl. Forex Impact)
5DXd ADCs Revenue (incl. Forex Impact) (Unit: Bn JPY) FY2024 Q3 FY2024 vs Oct YoY YTD Results Forecast (as of Jan) Forecast ENHERTU 421.6 +127.1 628.8 +17.0 Product Sales 404.4 +128.4 539.9 +16.9 Upfront and Milestone Payments, etc. 17.1 -1.3 88.9 +0.1 DATROWAY 4.8 - 6.8 -11.0 Product Sales - - 0.4
Slide 36: 5DXd ADCs Upfront and Milestone Payments
5DXd ADCs Upfront and Milestone Payments (Unit: Bn JPY) FY2024 Forecast Total Consideration Asset Item FY2024 Q3 Results YoY vs Oct Forecast (As of Jan) (as of Dec 2024) Upfront Payment 7.7 +0.1 10.2 - 149.0 Regulatory Milestones 8.6 -1.4 21.3 +0.1 141.6 ENHERTU® Quid Related Payment 0.9 +0.0 1.2 -
Slide 37: Major R&D Milestones (ENHERTU)
Major R&D Milestones (ENHERTU®) As of Jan 2025 Target indication FY2024 Project FY2025 [phase, study name] H1 H2 • HER2+, adjuvant* [Ph3, DESTINY-Breast05] • TLR anticipated • HR+/HER2 low or HER2 ultralow, chemo naive • Filing accepted（JP) • Regulatory decision • Filing accepted（EU) [Ph3, DESTINY-B
Slide 38: Major R&D Milestones (DATROWAY)
Major R&D Milestones (DATROWAY®) As of Jan 2025 Target indication FY2024 Project FY2025 [phase, study name] H1 H2 • non-squamous, 2L+ • Regulatory submission [Ph3, TROPION-Lung01] withdrawn (US/EU) • EGFR mutated, previously treated (incl. EGFR • Regulatory decision • Filing accepted (US) directed t
Slide 39: Major R&D Milestones (HER3-DXd, I-DXd, R-DXd)
Major R&D Milestones (HER3-DXd, I-DXd, R-DXd) As of Jan 2025 Target indication FY2024 Project FY2025 [phase, study name] H1 H2 • EGFR mutated, 3L [Ph2, HERTHENA-Lung01] • CRL received (US) NSCLC • EGFR mutated, 2L [Ph3, HERTHENA-Lung02] • TLR obtained HER3-DXd • HER2+, 2L+ BC [Ph1b/2, HERTHENA-Breas
Slide 40: Major R&D Milestones (Next Wave)
Major R&D Milestones (Next Wave) As of Jan 2025 Target indication FY2024 Project FY2025 [phase, study name] H1 H2 • FLT3-ITD negative AML, 1L VANFLYTA® • Study started [Ph3, QuANTUM-Wild] • r/r PTCL • Approved (JP) [Registrational Ph2, VALENTINE-PTCL01] EZHARMIA® • NSCLC (without AGA and PD-L1≥50%),
Slide 41: Major R&D Pipeline: 5DXd ADCs ①
Major R&D Pipeline: 5DXd ADCs ① As of Jan 2025 Phase 1 Phase 1/2 Phase 2 (US/EU/Asia) HER2 low BC (JP/US/EU/Asia) NSCLC (US/EU/Asia) HER2+ BC 2L+/1L (US/EU/Asia) CRC, BTC, HCC 2L+ (JP/US/EU/Asia) (JP/US/EU/Asia) ES-SCLC 2L+ chemo naïve/post chemo DESTINY-Breast07 MK-1022-011 HER2 expressing solid tu
Slide 42: Major R&D Pipeline: 5DXd ADCs ②
Major R&D Pipeline: 5DXd ADCs ② As of Jan 2025 Phase 2/3 Phase 3 Regulatory phase (JP/US/EU/Asia) (JP/US/EU/Asia) HER2+ BC (JP/US/EU/Asia) non-squamous NSCLC (w/o (JP/US/EU/Asia) TNBC (PD-1/PD-L1 inhibitor (JP/EU) HR+ and HER2 low or HER2 ultralow 1 platinum-resistant ovarian cancer 2L+ adjuvant* AG
Slide 43: Major R&D Pipeline: Next Wave
Major R&D Pipeline: Next Wave As of Jan 2025 Phase 1 Phase 1/2 Phase 2 Phase 3 Regulatory phase ® ® ® DS-1055 (JP/US) DS-3939 (JP/US/EU/Asia) EZHARMIA (EU) TURALIO (Asia) DAICHIRONA (JP) Anti-GARP antibody TA-MUC1-directed ADC EZH1/2 inhibitor CSF-1/KIT/FLT3 inhibitor COVID-19 mRNA vaccine (mutant s
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_jp@daiichisankyo.com 44
Daiichi Sankyo Co Ltd Ord — Q3 2024 Earnings Presentation on 6ix