Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — Daiichi Sankyo Co Ltd Ord — Q2 2024 Earnings Presentation
47 slides from Daiichi Sankyo's earnings presentation, Oct 31, 2024
Slide 1: FY2024 Q2 Financial Results Presentation
FY2024 Q2 Financial Results Presentation DAIICHI SANKYO CO., LTD. Hiroyuki Okuzawa Representative Director, President & COO October 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 FY2024 Q2 Financial Results 2 FY2024 Forecast 3 Business Update 4 R&D Update 5 Appendix 3
Slide 4: Overview of FY2024 Q2 Results
Overview of FY2024 Q2 Results (Bn JPY) FY2023 Q2 YTD FY2024 Q2 YTD YoY Results Results Revenue 726.3 882.7 +21.5% 156.4 Cost of sales *1 188.4 193.0 4.6 SG&A expenses *1 276.6 329.9 53.2 DXd ADC profit share *2 78.8 104.8 26.0 Other SG&A expenses 197.8 225.1 27.3 R&D expenses *1 166.0 193.3 27.3 Cor
Slide 5: Revenue
Revenue Increased by 156.4 Bn JPY (Increased by 116.7 Bn JPY excl. forex impact) (Bn JPY) Positive Factors Negative Factors FY2023 Q2 FY2023 YTD Results Q2 Results 726.3 Japan Business Unit Lixiana +10.8 Daiichi Sankyo -41.1 Japan Business Enhertu +5.1 Espha (incl. Innovative Pharmaceuticals, Japan
Slide 6: Core Operating Profit
Core Operating Profit Increased by 71.3 Bn JPY (Increased by 72.6 Bn JPY excl. forex impact) (Bn JPY) Revenue +156.4 incl. forex impact of +39.6 FY2023 Q2 YTD FY2023 Q2 Results Results 95.3 Cost of Sales -7.1 Improvement in cost of sales ratio by change in product mix Revenue Revenue 156.4 SG&A Expe
Slide 7: Profit Attributable to Owners of the Company
Profit Attributable to Owners of the Company Increased by 49.7 Bn JPY (Bn JPY) Temporary Income/Expenses +20.6 (Profit Increased) FY2023 Q2 FY2024 Q2 YoY YTD Results YTD Results FY2023 Q2 YTD Temporary Income 0.7 20.3*1 +19.6 FY2023 Q2 Results Results 97.0 Temporary Expenses 1.0 0.0 -1.0 Core Core O
Slide 8: Agenda
Agenda 1 FY2024 Q2 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 Apr.) (As of Oct.) Revenue 1,750.0 1,830.0 +80.0 Revenue : Increase by forex impact, sales expansion of Lixiana and Enhertu, etc. Cost of sales *1 395.0 410.0 +15.0 ：Sales decrease of GE injectables in ARU, delay i
Slide 10: Agenda
Agenda 1 FY2024 Q2 Financial Results 2 FY2024 Forecast 3 Business Update 4 R&D Update 5 Appendix 10
Slide 11: ENHERTU Performance
ENHERTU® Performance Global Product Sales Q2 YTD Product Sales Result 261.3Bn JPY (YoY +87.9Bn JPY) FY2024 Forecast 523.0Bn JPY (vs Apr Forecast +14.7Bn JPY) + 51% ◆ Key Growth Factors (YoY YTD Results) Achieved double-digits growth rate in all regions leading by HER2+ 261.3 Bn JPY BC 2L and HER2 lo
Slide 12: Co-development and Co-commercialization for MK-6070
Co-development and Co-commercialization for MK-6070 Added MK-6070*, which is being developed by Merck & Co., Inc., Rahway, NJ, USA (MRK), to the existing global co-development and co-commercialization agreement for 3 DXd ADC products (HER3-DXd, I-DXd, R-DXd (DS-6000)) Development Manufacturing ◆ Co-
Slide 13: Other Regional Initiatives
Other Regional Initiatives Japan ◆ DAICHIRONA®INTRAMUSCULAR INJECTION COVID-19 Vaccine ➢ Sep. 2024 Launched Omicron JN.1-adapted ｍRNA vaccine ◆ FLUMIST®INTRANASAL SPRAY Influenza Vaccine ➢ Oct. 2024 Launched Intranasal live attenuated influenza vaccine • Trivalent vaccine (2 types of type A, 1 type
Slide 14: Meeting Information
Meeting Information ◆ Meeting title: Discussion meeting on sustainability (Value Report 2024) ◆ Date and time: Monday, December 23, 2024 10:00-11:30am (JST) ◆ Speaker: Okuzawa COO, Matsumoto CHRO*, Nishii Outside Director, Nohara Outside Director and others * Chief Human Resources Officer ◆ Meeting
Slide 15: Agenda
Agenda 1 FY2024 Q2 Financial Results 2 FY2024 Forecast 3 Business Update 4 R&D Update 5 Appendix 15
Slide 16: 5DXd ADCs Update / Next Wave Update / Science and Technology Day 2024 / News Flow
5DXd ADCs Update Next Wave Update Science and Technology Day 2024 News Flow 16
Slide 17: ENHERTU Regulatory updates
ENHERTU® Regulatory updates DESTINY-Breast06, DESTINY-Gastric06, DESTINY-Lung05 Indication expansion in each country and region HR positive and HER2 low or ultralow BC (chemo naïve) (DESTINY -Breast06) ◼ Aug 2024：Filing accepted in EU ◼ Aug 2024：Breakthrough Designation granted by FDA in the US ◼ Oc
Slide 18: ENHERTU HER2 expressing NSCLC update
ENHERTU® HER2 expressing NSCLC update DESTINY-Lung03 Ph1b (WCLC 2024) ENHERTU® monotherapy cohort showed clinical benefit in pretreated HER2 overexpressing NSCLC PFS and OS of ENHERTU® monotherapy ORR Data cutoff: April 1st, 2024 ◼ Exploratory analyses showed promising activity in HER2-OE NSCLC w an
Slide 19: Dato-DXd TROPION-Lung01
Dato-DXd TROPION-Lung01 Topline OS results (WCLC 2024) Clinically meaningful trend continued in NSQ NSCLC (2L+) Overall Survival in NSQ NSCLC Overall Survival: subgroup analysis Data cutoff: Mar 1st, 2024 ◼ In ITT population, OS results numerically favored Dato-DXd compared to docetaxel (mOS 12.9mo
Slide 20: Computational pathology platform for TROP2 biomarker
Dato-DXd Computational pathology platform for TROP2 biomarker QCS analysis on TROPION-Lung01 PFS (WCLC 2024) TROP2 QCS-NMR is a promising biomarker for Dato-DXd in NSQ/non-AGA NSCLC Population and Methods Efficacy by TROP2 QCS-NMR status in NSQ/non-AGA BEP • QCS is a computational pathology approach
Slide 21: Combination therapy for early-stage NSCLC
Dato-DXd Combination therapy for early-stage NSCLC NeoCOAST-2 Ph2 (WCLC 2024) Interim result showed encouraging efficacy and manageable safety profile in neoadjuvant setting for resectable NSCLC NeoCOAST-2 study design Neoadjuvant for 4 cycles q3w Adjuvant for up to 1 year Eligible patient Arm 1: •
Slide 22: Expand Dato-DXd treatment to HR positive BC
Dato-DXd Expand Dato-DXd treatment to HR positive BC TROPION-Breast01 Ph3 Topline overall survival results were announced in Sep 2024 TROPION-Breast01 in BC map TROPION-Breast01 ✓ BC with inoperable or metastatic HR positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) previously treated wit
Slide 23: Further evaluation in early stage NSCLC
Dato-DXd Further evaluation in early stage NSCLC TROPION-Lung12 Ph3 New Ph3 combination study w/ rilvegostomig in NSCLC with ctDNA-positive or at least one high-risk pathological feature starts TROPION-Lung12 study design Dato-DXd + rilvegostomig q3w Eligible patient • Stage I, treatment-naive adeno
Slide 24: HER3-DXd EGFR mutated NSCLC update
HER3-DXd EGFR mutated NSCLC update HERTHENA-Lung01, HERTHENA-Lung02 HERTHENA-Lung02 met its primary endpoint of PFS ◼ In Sep 2024, TLR of HERTHENA-Lung02 were disclosed Clinical studies of HER3-DXd ✓ HER3-DXd demonstrated statistically significant in EGFR mutated NSCLC improvement in PFS, the primar
Slide 25: HER3-DXd in breast cancer
HER3-DXd HER3-DXd in breast cancer ICARUS-Breast01 Ph2 (ESMO 2024) HER3-DXd showed clinically meaningful activity and manageable safety profile in patients with HR+/HER2- BC progressing after 2L+ of therapy including CDK4/6i Antitumor activity Confirmed ORR: 53.5% (95% CI: 43.2-63.6) mPFS: 9.4 month
Slide 26: I-DXd ES-SCLC update
I-DXd ES-SCLC update IDeate-Lung01 Ph2 (WCLC 2024) I-DXd demonstrated promising efficacy and tolerability in pretreated ES-SCLC and 12mg/kg was selected for Ph3 study cORR (upper), PFS and OS (lower) IDeate-Lung01 Ph2 study comparing 2 doses in patients with ES-SCLC who received ≥ 1 prior line of PB
Slide 27: Other clinical updates
5DXd ADCs Other clinical updates ENHERTU® ◼ Aug 2024: DESTINY-BTC01 Ph3 combination study with rilvegostomig for BTC 1L started Dato-DXd ◼ Oct 2024: TROPION-Lung15 Ph3 study for mono and combination with osimertinib for EGFR mutated NSCLC 2L+ started HER3-DXd ◼ MK-1022-011 Ph1b/2 study for CRC, BTC
Slide 28: 5DXd ADCs Update / Next Wave Update / Science and Technology Day 2024 / News Flow
5DXd ADCs Update Next Wave Update Science and Technology Day 2024 News Flow 28
Slide 29: DS-9606 Ph1 study dose escalation part
DS-9606 Ph1 study dose escalation part (CLDN6-directed ADC) ESMO 2024 Reported preliminary safety and efficacy data at ESMO 2024 ◼ DS-9606 is a CLDN6 directed, modified PBD ADC from Daiichi Sankyo’s second ADC platform ◼ CLDN6 is an important component of cell-to-cell tight junctions and nearly abse
Slide 30: MK-6070 Expanding collaboration with MRK
MK-6070 (DS3280) Expanding collaboration with MRK Plan to evaluate combination with I-DXd in dose escalation study for MK-6070 MoA and profile Ph1/2 study design Dose escalation: N=232 MK-6070 q1w Eligible patients MK-6070 (DS3280) • histologically or ◼ T-cell engager targeting cytologically confirm
Slide 31: 5DXd ADCs Update / Next Wave Update / Science and Technology Day 2024 / News Flow
5DXd ADCs Update Next Wave Update Science and Technology Day 2024 News Flow 31
Slide 32: Science and Technology Day 2024
Science and Technology Day 2024 Date & Time Major topics Format • Latest publications at medical conferences Monday, December 16th, 2024 • R&D strategy • R&D updates 5:30pm-7:30pm (EST) • Manufacturing and supply Tuesday, December 17th 7:30am-9:30am (JST) Virtual (Zoom) Content will be delivered on-
Slide 33: 5DXd ADCs Update / Next Wave Update / Science and Technology Day 2024 / News Flow
5DXd ADCs Update Next Wave Update Science and Technology Day 2024 News Flow 33
Slide 34: FY2024 News Flow
FY2024 News Flow As of Oct 2024 Planned major data disclosures Key data readouts San Antonio Breast Cancer Symposium (SABCS, Dec 10-13, 2024) DESTINY-Breast11*: HER2+ BC, neoadjuvant, Ph3 ENHERTU® • FY2024 H2 DESTINY-Breast06: HR+/HER2 low BC, chemo naïve, Ph3 TROPION-Breast02*: ENHERTU® • Follow-up
Slide 35: Agenda
Agenda 1 FY2024 Q2 Financial Results 2 FY2024 Forecast 3 Business Update 4 R&D Update 5 Appendix 35
Slide 36: Revenue: Business Units (incl. Forex Impact)
Revenue: Business Units (incl. Forex Impact) (Bn JPY) FY2023 Q2 YTD FY2024 Q2 YTD YoY Results Results Japan Business 246.8 239.7 -7.2 Daiichi Sankyo Healthcare 37.4 42.5 +5.1 Oncolgy Business 148.8 215.5 +66.7 Enhertu 145.1 210.7 +65.6 Turalio 2.6 3.2 +0.6 Vanflyta 1.1 1.7 +0.5 American Regent 98.7
Slide 37: Revenue: Major Products in Japan
Revenue: Major Products in Japan (Bn JPY) FY2023 Q2 YTD FY2024 Q2 YTD YoY Results Results Lixiana anticoagulant 57.1 67.9 +10.8 Tarlige pain treatment 22.7 27.8 +5.1 Treatment for osteoporosis/ inhibitor of the progression of Pralia bone erosion associated with rheumatoid arthritis 21.1 21.1 +0.0 Vi
Slide 38: 5DXd ADCs Revenue (incl. Forex Impact)
5DXd ADCs Revenue (incl. Forex Impact) (Unit: Bn JPY) FY2024 Q2 FY2024 vs Apr YoY YTD Results Forecast (as of Oct) Forecast ENHERTU 271.7 +88.7 611.8 +26.5 Product Sales 261.3 +87.9 523.0 +14.7 Upfront and Milestone Payments, etc. 10.4 +0.8 88.8 +11.8 Dato-DXd 3.2 - 17.8 +0.2 Product Sales - - 5.8 +
Slide 39: 5DXd ADCs Upfront and Milestone Payments
5DXd ADCs Upfront and Milestone Payments (Unit: Bn JPY) FY2024 Q2 FY2024 Forecast vs Apr Total Consideration Asset Item YoY YTD Results (as of Oct) Forecast (as of Sep 2024) Upfront Payment 5.1 +0.2 10.2 - 149.0 Regulatory Milestones 4.7 +0.5 21.2 +11.8 * 137.7 ENHERTU Quid Related Payment 0.6 +0.0
Slide 40: Major R&D Milestones (ENHERTU)
Major R&D Milestones (ENHERTU®) As of Oct 2024 Target indication FY2024 Project FY2025 [phase, study name] H1 H2 • HER2+, adjuvant* • TLR anticipated [Ph3, DESTINY-Breast05] • HR+/HER2 low or HER2 ultralow, chemo • Filing accepted（EU) • Filing accepted（JP/US) naive [Ph3, DESTINY-Breast06] BC • HER2+
Slide 41: Major R&D Milestones (Dato-DXd)
Major R&D Milestones (Dato-DXd) As of Oct 2024 Target indication FY2024 Project FY2025 [phase, study name] H1 H2 • 2L+, non-squamous, • Regulatory decision [Ph3, TROPION-Lung01] anticipated (US) • 1L, non-squamous, PD-L1 high, rilvegostomig • Study started combo [Ph3, TROPION-Lung10] • Stage I adeno
Slide 42: Major R&D Milestones (HER3-DXd, I-DXd, DS-6000)
Major R&D Milestones (HER3-DXd, I-DXd, DS-6000) As of Oct 2024 Target indication FY2024 Project FY2025 [phase, study name] H1 H2 • EGFR mutated, 3L • CRL received (US) [Ph2, HERTHENA-Lung01] NSCLC • EGFR mutated, 2L HER3-DXd • TLR obtained [Ph3, HERTHENA-Lung02] CRC, BTC, • 2L+ [Ph1/2, MK-1022-011]
Slide 43: Major R&D Milestones (Next Wave)
Major R&D Milestones (Next Wave) As of Oct 2024 Target indication FY2024 Project FY2025 [phase, study name] H1 H2 • r/r PTCL valemetostat • Approved (JP) [Registrational Ph2, VALENTINE-PTCL01] mirogabalin • DPNP • Approved (CN) • COVID-19 mRNA vaccine (mutant strain), • Regulatory decision DAICHIRON
Slide 44: Major R&D Pipeline: 5DXd ADCs ①
Major R&D Pipeline: 5DXd ADCs ① As of Oct 2024 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) in prep CRC, BTC, HCC 2L+ (JP/US/EU/Asia) (JP/US/EU/Asia) ｓolid tumors Chemo naïve/post chemo DESTINY-Breast07 MK-1022-011 HER2 expressing
Slide 45: Major R&D Pipeline: 5DXd ADCs ②
Major R&D Pipeline: 5DXd ADCs ② As of Oct 2024 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/US/EU) HR+ and HER2 low or HER2 1 platinum-resistant ovarian cancer 2L+ adjuvant* AGA, PD-
Slide 46: Major R&D Pipeline: Next Wave
Major R&D Pipeline: Next Wave As of Oct 2024 Phase 1 Phase 1/2 Phase 2 Phase 3 Regulatory phase DS-1055 (JP/US) DS-3939 Valemetostat (EU) Pexidartinib (JP/Asia) DS-5670 (JP) Anti-GARP antibody TA-MUC1-directed ADC EZH1/2 inhibitor CSF-1/KIT/FLT3 inhibitor COVID-19 mRNA vaccine (mutant strain), COVID
Slide 47: 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.com 47
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