Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — Daiichi Sankyo Co Ltd Ord — Q1 2025 Earnings Presentation
44 slides from Daiichi Sankyo's earnings presentation, Jul 31, 2025
Slide 1: FY2025 Q1 Financial Results Presentation
FY2025 Q1 Financial Results Presentation DAIICHI SANKYO CO., LTD. Koji Ogawa Senior Executive Officer, CFO July 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 FY2025 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 3
Slide 4: Overview of FY2025 Q1 Results
Overview of FY2025 Q1 Results (Bn JPY) FY2024 Q1 FY2025 Q1 YoY Results Results Revenue 436.2 474.6 +8.8% 38.4 Cost of sales *1 95.0 92.3 -2.6 SG&A expenses *1 167.6 180.0 12.4 DXd ADC profit share *2 56.8 60.6 3.8 Other SG&A expenses 110.8 119.4 8.6 R&D expenses *1 100.7 105.9 5.3 Core operating pro
Slide 5: Revenue
Revenue Increased by 38.4 Bn JPY (Increased by 57.6 Bn JPY excl. forex impact) (Bn JPY) Positive Factors Negative Factors FY2024FY2024 Q1 Results Q1 Results 436.2 Japan Business Unit Belsomra +5.1 Realized gains of unrealized -5.6 Japan Business Lixiana +2.8 gains of inventory for Daiichi (incl. Inn
Slide 6: Core Operating Profit
Core Operating Profit Increased by 23.4 Bn JPY (Increased by 23.0 Bn JPY excl. forex impact) (Bn JPY) Revenue +38.4 incl. forex impact of -19.2 FY2024 Q1 Q1 FY2024 Results Results 72.9 Cost of Sales +1.5 Revenue Improvement in cost of sales ratio by change in product mix Revenue 38.4 SG&A Expenses +
Slide 7: Profit Attributable to Owners of the Company
Profit Attributable to Owners of the Company Increased by 0.1 Bn JPY (Bn JPY) Temporary Income/Expenses -19.7 (Profit Decreased) FY2024 Q1 FY2025 Q1 YoY Results Results Temporary Income 20.1*1 0.7 -19.4 FY2024 Q1 Q1 FY2024 Results Results 85.4 Temporary Expenses 0.0 0.3 +0.3 Core Core Operating *1 G
Slide 8: Agenda
Agenda 1 FY2025 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 8
Slide 9: Performance
Performance 155.2 Bn JPY Q1 Global Product Sales Result 155.2 Bn JPY 129.6 Bn JPY + 8% 8.4 22.3 YoY +25.6 Bn JPY (+19.7%) Progress vs Apr. Forecast 23.4% 7.8 17.8 +25% 39.5 Maintained the No.1 New Patient Share across Major Countries and Regions 35.2 +12% HR positive, HER2 low or ultralow BC (chem
Slide 10: Agenda
Agenda 1 FY2025 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 10
Slide 11: 5DXd ADCs Update
5DXd ADCs Update Next Wave Update Out Licensed Products Update IR Event Information News Flow 11
Slide 12: ENHERTU: More Advancements in HER2 Positive Breast Cancer
ENHERTU® More Advancements in HER2 Positive Breast Cancer DESTINY-Breast09 Ph3 (ASCO 2025) DESTINY-Breast09 evaluates the efficacy and safety of ENHERTU® ± pertuzumab vs SOC in 1L HER2 positive mBC DESTINY-Breast09 Study Design Eligible Patient ENHERTU® + placebo Primary endpoint • HER2 positive adv
Slide 13: ENHERTU: Establish a New 1L Treatment for HER2 Positive BC
ENHERTU® Establish a New 1L Treatment for HER2 Positive BC DESTINY-Breast09 Ph3 (ASCO 2025) ENHERTU® in combination with pertuzumab (T-DXd+P) showed statistically significant and clinically meaningful PFS in the 1L treatment of HER2+ mBC Antitumor Activity (PFS (BICR)) Safety Data cutoff: February 2
Slide 14: ENHERTU in Early Breast Cancer
First Ph3 Study Demonstrated Benefit of ENHERTU® ENHERTU® in Early Breast Cancer DESTINY-Breast11 Ph3 ENHERTU® followed by THP demonstrated statistically significant and clinically meaningful improvement in pCR in high-risk HER2 positive eBC neoadjuvant setting DESTINY-Breast11 Study Design ENHERTU®
Slide 15: ENHERTU: For Earlier Treatment of HER2 Positive GC
ENHERTU® For Earlier Treatment of HER2 Positive GC DESTINY-Gastric04 Ph3 (ASCO 2025) DESTINY-Gastric04 establishes ENHERTU® as global 2L HER2+ SOC for patients with HER2+ mGC/GEJA Data cutoff: October 24, 2024 ENHERTU® demonstrated mOS 14.7 mo with 30% reduction in risk of death compared with ramu
Slide 16: ENHERTU: New Challenge in Gynecological Cancers
ENHERTU® New Challenge in Gynecological Cancers DESTINY-Endometrial01 Ph3 Expand development for 1L therapy in HER2 expressing mismatch repair proficient (pMMR) endometrial cancer DESTINY-Endometrial01 Study Design Eligible Patient ENHERTU® 5.4 mg/kg q3w • Primary Stage III, Stage IV or recurrent +
Slide 17: ENHERTU: New Challenge in Gynecological Cancers
ENHERTU® New Challenge in Gynecological Cancers DESTINY-Endometrial02 Ph3 New Ph3 Study of ENHERTU® for adjuvant therapy in HER2 expressing high risk Endometrial cancer DESTINY-Endometrial02 Study Design Eligible Patient ENHERTU® 5.4 mg/kg • Stage IIC or III (FIGO 2023) q3w, 17 cycles • HER2 IHC 2+
Slide 18: ENHERTU: New Formulation to Provide Better Treatment Option
ENHERTU® New Formulation to Provide Better Treatment Option Ph1 study will inform subcutaneous formulation dose selection Subcutaneous Formulation Study Dose escalation Dose expansion Eligible Patient • Recurrent and metastatic solid tumors Subcutaneous Subcutaneous RDE Ph3 study ENHERTU® ENHERTU® n
Slide 19: DATROWAY: First Step into Lung Cancer
DATROWAY® First Step into Lung Cancer TROPION-Lung05 Ph2, TROPION-Lung01 Ph3 DATROWAY® first approval for lung cancer in the US Major Studies for Lung Cancer Approved in the US for the treatment of patients with locally advanced or metastatic EGFR mutated NSCLC in June 2025 The approval is based
Slide 20: DATROWAY: TROP2 NMR as a Potential Biomarker in NSCLC
DATROWAY® TROP2 NMR as a Potential Biomarker in NSCLC TROPION-Lung02 Ph1b (ASCO 2025) Retrospective analysis in 1L NSCLC showed a trend towards improved response to DATROWAY® in TROP2 NMR* positive patients, measured by QCS** Antitumor Activity TROPION-Lung02 (Ph1b) Evaluate efficacy and safety of
Slide 21: HER3-DXd: EGFR mutated NSCLC 3L Treatment
HER3-DXd EGFR mutated NSCLC 3L Treatment HERTHENA-Lung01 (Ph2) and HERTHENA-Lung02 (Ph3) Regulatory submission in the US based on HERTHENA-Lung01 was voluntarily withdrawn in May 2025 HERTHENA-Lung02 PFS (upper) and OS (lower) This application was accepted by the FDA based on the results from HERT
Slide 22: HER3-DXd: Expand HR+/HER2- mBC Treatment Options
HER3-DXd Expand HR+/HER2- mBC Treatment Options HERTHENA-Breast04 Ph3 New Ph3 study of HER3-DXd for HR+/HER2- mBC post CDK4/6 inhibitor treatment in 1L HERTHENA-Breast04 Study Design Eligible Patient • HR+/HER2- mBC (HER2 IHC 0 or 1+ or 2+/ISH-) • Chemotherapy and ADC naive HER3-DXd • Eligible for o
Slide 23: I-DXd: Addressing Unmet Needs in ES-SCLC
I-DXd Addressing Unmet Needs in ES-SCLC IDeate-Lung01 Ph2 Promising data from dose extension part in ES-SCLC in Apr 2025 IDeate-Lung01 Study Design Eligible Patients Dose optimization Dose extension • ES-SCLC I-DXd • Prior therapy with at least one 8.0mg/kg, q3w platinum-based line R • Minimum of tw
Slide 24: Other Clinical and Regulatory Approval Status Updates
5DXd ADCs Other Clinical and Regulatory Approval Status Updates HER3-DXd June 2025: LIGHTBEAM-U01 Ph1/2 study for relapsed or refractory pediatric cancers, hepatoblastoma or rhabdomyosarcoma started I-DXd May 2025: IDeate-Esophageal01 Ph3 study for ESCC 2L started June 2025: IDeate-Prostate01
Slide 25: Next Wave Update
5DXd ADCs Update Next Wave Update Out Licensed Products Update IR Event Information News Flow 25
Slide 26: DS3610: New STING Agonist ADC
DS3610 New STING Agonist ADC DS3610 delivers STING* agonists to cancer cells via an antibody targeting a cancer antigen and activates antitumor immunity within the tumor microenvironment Mechanism of Action ADC that combines Daiichi Sankyo original STING T cell agonists with an antibody The nove
Slide 27: Out Licensed Products Update
5DXd ADCs Update Next Wave Update Out Licensed Products Update IR Event Information News Flow 27
Slide 28: Out Licensed Products Status Updates
Out Licensed Products Status Updates Taletrectinib (IBTROZI ®, DS-6051) Taletrectinib is an oral ROS1/NTRK inhibitor generated by Daiichi Sankyo as DS-6051 Daiichi Sankyo entered into a license agreement (product licensing) with AnHeart Therapeutics Inc.* in December 2018 and granted AnHeart The
Slide 29: IR Event Information
5DXd ADCs Update Next Wave Update Out Licensed Products Update IR Event Information News Flow 29
Slide 30: Upcoming IR Events
Upcoming IR Events WCLC 2025 Highlights ESMO 2025 Highlights Date, time and format Date, time and format Wednesday, September 17, 2025 Tuesday, October 21, 2025 7:00-8:15pm EDT 8:00-9:30am EDT Thursday, September 18, 2025 9:00-10:30pm JST 8:00-9:15am JST Virtual (Zoom) Virtual (Zoom) The content wil
Slide 31: News Flow
5DXd ADCs Update Next Wave Update Out Licensed Products Update IR Event Information News Flow 31
Slide 32: FY2025 News Flow
FY2025 News Flow As of Jul 2025 Planned major data disclosures Regulatory decisions World Conference on Lung Cancer（WCLC, Sep 6-9, 2025） DESTINY-Breast06: ENHERTU® HR+/HER2 low or HER2 ultralow, chemo naïve, Ph3 TROPION-Lung01: NSCLC, 2L+, Ph3 • JP: FY2025 H1 DATROWAY® • Retrospective analysis （intr
Slide 33: Agenda
Agenda 1 FY2025 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 33
Slide 34: Revenue: Business Units (incl. Forex Impact)
Revenue: Business Units (incl. Forex Impact) (Bn JPY) FY2024 Q1 FY2025 Q1 YoY Results Results Japan Business 117.7 125.0 +7.3 Daiichi Sankyo Healthcare 20.0 20.9 +0.9 Oncolgy Business 106.4 131.2 +24.8 Enhertu 104.1 124.6 +20.5 Datroway - 3.1 +3.1 Turalio 1.5 1.6 +0.1 Vanflyta 0.9 1.9 +1.0 American
Slide 35: Revenue: Major Products in Japan
Revenue: Major Products in Japan (Bn JPY) FY2024 Q1 FY2025 Q1 YoY Results Results Lixiana anticoagulant 34.9 37.7 +2.8 Tarlige pain treatment 14.2 16.5 +2.4 Treatment for osteoporosis/ inhibitor of the progression of Pralia bone erosion associated with rheumatoid arthritis 11.1 12.4 +1.3 anti-cancer
Slide 36: 5DXd ADCs Revenue (incl. Forex Impact)
5DXd ADCs Revenue (incl. Forex Impact) (Unit: Bn JPY) FY2025 Q1 FY2025 YoY YoY Results Forecast ENHERTU® 161.0 +26.2 761.3 +109.9 Product Sales 155.2 +25.6 662.1 +109.3 Upfront and Milestone Payments, etc. 5.8 +0.6 99.2 +0.6 DATROWAY® 8.7 +7.1 29.9 +22.1 Product Sales 5.3 +5.3 21.6 +20.1 Upfront and
Slide 37: 5DXd ADCs Upfront and Milestone Payments
5DXd ADCs Upfront and Milestone Payments (Unit: Bn JPY) FY2025 Q1 FY2025 Total Consideration Asset Item YoY YoY Results Forecast (as of Jun 2025) Upfront Payment 2.6 - 10.2 +0.0 149.0 Regulatory Milestones 3.0 +0.6 12.5 -16.7 185.9 ENHERTU® Quid Related Payment 0.3 - 1.2 - 17.2 Sales Milestone - - 7
Slide 38: Major R&D Milestones (ENHERTU)
Major R&D Milestones (ENHERTU®) As of Jul 2025 Target indication FY2025 Project FY2026 [phase, study name] H1 H2 • HER2+, adjuvant*1 [Ph3, DESTINY-Breast05] • TLR anticipated • Regulatory decision • HR+/HER2 low or HER2 ultralow, chemo naive [Ph3, DESTINY-Breast06] anticipated (JP) BC • Filling acce
Slide 39: Major R&D Milestones (DATROWAY)
Major R&D Milestones (DATROWAY®) As of Jul 2025 Target indication FY2025 Project FY2026 [phase, study name] H1 H2 • EGFR mutated, previously treated EGFR- directed therapy and PBC • Approved (US) [Ph2, TROPION-Lung05*1] • non-squamous, w/o AGA, PD-L1 TPS <50%, 1L, pembrolizumab combo • TLR anticipat
Slide 40: Major R&D Milestones (HER3-DXd, I-DXd, R-DXd)
Major R&D Milestones (HER3-DXd, I-DXd, R-DXd) As of Jul 2025 Target indication FY2025 Project FY2026 [phase, study name] H1 H2 • EGFR mutated, 3L • Regulatory submission NSCLC [Ph2, HERTHENA Lung01] withdrawn (US) • TNBC, HR low and HER2 negative BC HER3-DXd neoadjuvant • Study started BC [Ph2, HERT
Slide 41: Major R&D Pipeline: 5DXd ADCs ①
Major R&D Pipeline: 5DXd ADCs ① As of Jul 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/Asia) r/r RMS, HBL pediatric (JP/US/EU/Asia) (JP/US/EU/Asia) ES-SCLC 2L+ chemo naïve/post chemo （combo) (chemo combo) LIGHTBEAM-U01 HER2 expressing
Slide 42: Major R&D Pipeline: 5DXd ADCs ②
Major R&D Pipeline: 5DXd ADCs ② As of Jul 2025 Phase 2/3 Phase 3 Regulatory phase (JP/US/EU/Asia) (JP/US/EU/Asia) HER2+ BC (JP/US/EU/Asia) HER2 expressing BTC 1L (JP/US/EU/Asia) EGFR mutated NSCLC 1L (JP/US/EU/Asia) (JP/CN) HR+ and HER2 low or HER2 ultralow platinum-resistant ovarian cancer 2L+ adju
Slide 43: Major R&D Pipeline: Next Wave
Major R&D Pipeline: Next Wave As of Jul 2025 Phase 1 Phase 1/2 Phase 2 Phase 3 Regulatory phase DS-9606 (US/EU) DS-3939 (JP/US/EU/Asia) ® EZHARMIA (EU) ® TURALIO (Asia) ® VANFLYTA (CN) CLDN6-directed ADC TA-MUC1-directed ADC EZH1/2 inhibitor CSF-1/KIT/FLT3 inhibitor FLT3 inhibitor Solid tumors Solid
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
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