Daiichi Sankyo Company, Limited · TSE:4568
Daiichi Sankyo — Daiichi Sankyo Co Ltd Ord — Q1 2024 Earnings Presentation
42 slides from Daiichi Sankyo's earnings presentation, Jul 31, 2024
Slide 1: FY2024 Q1 Financial Results Presentation
FY2024 Q1 Financial Results Presentation DAIICHI SANKYO CO., LTD. Koji Ogawa Executive Officer, CFO July 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 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 3
Slide 4: Overview of FY2024 Q1 Results
Overview of FY2024 Q1 Results (Bn JPY) FY2023 Q1 FY2024 Q1 YoY Results Results Revenue 350.8 436.2 +24.3% 85.3 Cost of sales *1 93.6 95.0 1.4 SG&A expenses *1 135.6 167.6 32.0 DXd ADC profit share *2 34.8 56.8 22.0 Other SG&A expenses 100.8 110.8 10.0 R&D expenses *1 77.2 100.7 23.5 Core operating p
Slide 5: Revenue
Revenue Increased by 85.3 Bn JPY (Increased by 55.0 Bn JPY excl. forex impact) (Bn JPY) Positive Factors Negative Factors FY2023FY2023 Q1 Results Q1 Results 350.8 Japan Business Unit Lixiana +7.0 Daiichi Sankyo -20.6 Japan Business Enhertu +3.4 Espha Japan Business 0.0 (incl. Innovative Pharmaceutic
Slide 6: Core Operating Profit
Core Operating Profit Increased by 28.4 Bn JPY (Increased by 30.4 Bn JPY excl. forex impact) (Bn JPY) Revenue +85.3 incl. forex impact of +30.4 FY2023 Q1 Results FY2023 Q1 Results 44.5 Cost of Sales -8.0 Revenue Improvement in cost of sales ratio by change in product mix Revenue 85.3 SG&A Expenses +
Slide 7: Profit Attributable to Owners of the Company
Profit Attributable to Owners of the Company Increased by 28.4 Bn JPY (Bn JPY) Temporary Income/Expenses +20.5 (Profit Increased) FY2023 Q1 FY2024 Q1 YoY Results Results Temporary Income 0.5 20.1*1 +19.6 FY2023 Q1 Q1 FY2023 Results Results 57.0 Temporary Expenses 0.9 0.0 -0.9 Core Core Operating *1
Slide 8: Agenda
Agenda 1 FY2024 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 8
Slide 9: ENHERTU Performance
ENHERTU® Performance Global Product Sales Q1 Product Sales Result ¥129.6Bn (YoY +¥47.9Bn) FY2024 Forecast ¥508.4Bn (YoY +¥112.4Bn) + 59% ◆ Key Growth Factors (YoY Quarterly Results) 129.6 Bn JPY Achieved over two digits growth rate in all regions leading by HER2+ BC 2L and HER2 low BC (post-chemo) U
Slide 10: Other Regional Initiatives
Other Regional Initiatives Japan ◆ EzharmiaⓇ Anti-Cancer Agent / EZH1 and EZH2 Inhibitor ➢ Approved for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) in June 2024 ◆ BelsomraⓇ Anti-Insomnia Treatment / Dual Orexin Receptor Antagonist ➢ Decision made to
Slide 11: Major Updates on Patent Disputes
Major Updates on Patent Disputes Dispute with Seagen (SGN) regarding Daiichi Sankyo ADC ① (Arbitration on ADC Technology) ◆ May 2024 Final award issued by an arbitrator has been finalized ◆ Jun. 2024 SGN has paid DS based on the Final award ➢ SGN has paid DS approx. U.S. $47 million (approx. 7.5 bn
Slide 12: Agenda
Agenda 1 FY2024 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 12
Slide 13: 5DXd ADCs Update
5DXd ADCs Update Next Wave Update WCLC/ESMO 2024 News Flow 13
Slide 14: Establish and expand DXd ADCs in Breast Cancer
5DXd ADCs Establish and expand DXd ADCs to address the broader spectrum of Breast Cancer Neoadjuvant Adjuvant 1L 2L+ HER2+ DESTINY-Breast11 DESTINY-Breast05 DESTINY-Breast09 20% Residual Disease DESTINY-Breast01/02/03 Evaluating TROPION-Breast04 TROPION potential TROPION DESTINY-Breast04 TNBC -Breas
Slide 15: ENHERTU: Earlier and broader treatment of HER2 low BC
ENHERTU® For earlier and broader treatment of HER2 low BC DESTINY-Breast06 study (ASCO 2024) DESTINY-Breast06 primary analysis data presented at ASCO 2024 DESTINY-Breast06 study design ENHERTU® 5.4 mg/kg q3w Key Eligibility • HR positive mBC • HER2 low (IHC 1+ or IHC 2+/ISH−) or R HER2 ultralow (IHC
Slide 16: ENHERTU: PFS benefit in HER2 low and ultralow mBC
ENHERTU® For earlier and broader treatment of HER2 low BC DESTINY-Breast06 study (ASCO 2024) ENHERTU® demonstrated a statistically significant and clinically meaningful PFS benefit in HR positive, HER2 low and HER2 ultralow mBC PFS (BICR) in HER2 low PFS (BICR) in ITT (HER2 low and HER2 ultralow) Ha
Slide 17: Approach to 1L treatment in HER2 positive BC
ENHERTU® Approach to 1L treatment in HER2 positive BC DESTINY-Breast07 study (ASCO 2024) Interim analysis of the Ph1b/2 study to evaluate ENHERTU® combination w/ or w/o pertuzumab in 1L HER2 positive BC shows robust efficacy and durability ENHERTU® monotherapy (n=75) ENHERTU® + pertuzumab (n=50) CR,
Slide 18: Addressing additional HER2 expressing solid tumors
ENHERTU® Addressing additional HER2 expressing solid tumors DESTINY-BTC01 study Based on the outcome from DESTINY-PanTumor02 study*, a new Ph3 study for 1L BTC in combination with rilvegostomig has been planned DESTINY-BTC01 study design Arm A Safety Run-in ENHERTU®+rilvegostomig Key Eligibility • A
Slide 19: Establish and expand DXd ADCs in Lung Cancer
5DXd ADCs Establish and expand DXd ADCs to address the broader spectrum of Lung Cancer Stage I - III 1L 2L+ PD-L1 < 50% PD-L1 > 50% HERTHENA HERTHENA -Lung02 -Lung01 EGFRm TROPION-Lung14 DESTINY-PanTumor02/ Lung01 TROPION-Lung15 HER2m DESTINY-Lung04 DESTINY-Lung01/02 HER2+ (IHC 3+) Others NSCLC AGA
Slide 20: Dato-DXd Progress in 2L+ NSCLC treatment
Dato-DXd Progress in 2L+ NSCLC treatment TROPION-Lung01 study Topline overall survival (OS) results were announced in May 2024 Dato-DXd 6.0 mg/kg Advanced or metastatic R NSCLC 2L+ 1:1 docetaxel N=600 75 mg/m2 Primary: PFS, OS Secondary: ORR, DOR, DCR, PK, safety etc. ◼ Dual primary endpoint PFS BIC
Slide 21: Insight on Dato-DXd combination for 1L NSCLC
Dato-DXd Insight on Dato-DXd combination for 1L NSCLC TROPION-Lung02 study (ASCO 2024) A subgroup analysis of Ph1 Dato-DXd combination study with pembrolizumab w/ or w/o PBC presented at ASCO 2024 Efficacy outcomes in 1L patients, overall and by PD-L1 statusa,b TROPION-Lung02 study • 1L advanced or
Slide 22: New treatment approach for 2L+ EGFR mutated NSCLC
Dato-DXd New treatment approach for 2L+ EGFR mutated NSCLC TROPION-Lung15 study New Ph3 study in 2L+ EGFR mutated NSCLC to evaluate Dato-DXd combination w/ or w/o osimertinib starts in FY2024 H1 TROPION-Lung15 study design Dato-DXd 6mg/kg q3w + osimertinib qd Key Eligibility • Advanced or metastatic
Slide 23: HER3-DXd EGFR mutated NSCLC 3L
HER3-DXd EGFR mutated NSCLC 3L HERTHENA-Lung01 FDA issued Complete Response Letter for BLA based on HERTHENA-Lung01 in June 2024 Clinical studies of HER3-DXd ◼ Filing was accepted based on HERTHENA-Lung01 study data in EGFR mutated NSCLC by the FDA in Dec 2023 ◼ In June 2024, due to findings pertain
Slide 24: 5DXd ADCs Clinical and Regulatory Progress
5DXd ADCs Clinical and Regulatory Progress Dato-DXd ◼ May 2024 : TROPION-Lung10 Ph3 combination study with rilvegostomig for PD-L1≥50% NSCLC 1L started ◼ May 2024 : TROPION-Lung14 Ph3 combination study with osimertinib for EGFR mutated NSCLC 1L started I-DXd ◼ May 2024 : IDeate-Pantumor02 Ph2 study
Slide 25: Next Wave Update
5DXd ADCs Update Next Wave Update WCLC/ESMO 2024 News Flow 25
Slide 26: Next Wave Clinical and Regulatory Progress
Next Wave Clinical and Regulatory Progress Valemetostat (relapsed/refractory peripheral T-cell lymphoma [PTCL]) ◼ Jun 2024: Approval in Japan TARLIGE ® (mirogabalin) (diabetic peripheral neuropathic pain [DPNP]) ◼ Jun 2024: Approval in China DAICHIRONA ® (COVID-19 mRNA vaccine) ◼ Apr 2024: Filing ac
Slide 27: WCLC/ESMO 2024 News Flow
5DXd ADCs Update Next Wave Update WCLC/ESMO 2024 News Flow 27
Slide 28: WCLC/ESMO 2024 Highlight
WCLC/ESMO 2024 Highlight Date & time Speakers Format Tuesday, September 17th, 2024 8:00-9:30am (EDT) 9:00-10:30pm (JST) Ken Takeshita Head of Global R&D Virtual (Zoom) Mark Rutstein Content will be delivered Head of Global Oncology on-demand after the meeting Clinical Development 28
Slide 29: News Flow
5DXd ADCs Update Next Wave Update WCLC/ESMO 2024 News Flow 29
Slide 30: FY2024 News Flow
FY2024 News Flow As of Jul 2024 Planned major data disclosures Regulatory decisions WCLC (Sep７-10, 2024） DESTINY-Gastric06: HER2+ GC, 3L+ • CN: FY2024 H1 DESTINY-Lung03: HER2+ NSCLC, 1L, Ph1b ENHERTU® ENHERTU® DESTINY-Lung05: HER2 mutant NSCLC, 2L+ • First data release • CN: FY2024 H2 IDeate-Lung01:
Slide 31: Agenda
Agenda 1 FY2024 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix 31
Slide 32: Revenue: Business Units (incl. Forex Impact)
Revenue: Business Units (incl. Forex Impact) (Bn JPY) FY2023 Q1 FY2024 Q1 YoY Results Results Japan Business 119.0 117.7 -1.3 Daiichi Sankyo Healthcare 17.1 20.0 +2.9 Oncolgy Business 70.6 106.4 +35.8 Enhertu 69.4 104.1 +34.7 Turalio 1.2 1.5 +0.3 Vanflyta - 0.9 +0.9 American Regent 50.7 55.9 +5.3 In
Slide 33: Revenue: Major Products in Japan
Revenue: Major Products in Japan (Bn JPY) FY2023 Q1 FY2024 Q1 YoY Results Results Lixiana anticoagulant 27.9 34.9 +7.0 Tarlige pain treatment 11.7 14.2 +2.5 Treatment for osteoporosis/ inhibitor of the progression of Pralia bone erosion associated with rheumatoid arthritis 10.7 11.1 +0.4 Vimpat anti
Slide 34: 5DXd ADCs Revenue (incl. Forex Impact)
5DXd ADCs Revenue (incl. Forex Impact) (Unit: Bn JPY) FY2024 Q1 FY2024 YoY YoY Results Forecast ENHERTU 134.8 +48.2 585.4 +136.2 Product Sales 129.6 +47.9 508.4 +112.4 Upfront and Milestone Payments 5.2 +0.4 77.0 +23.7 Dato-DXd 1.6 - 17.6 +11.2 Product Sales - - 5.6 +5.6 Upfront and Milestone Paymen
Slide 35: 5DXd ADCs Upfront and Milestone Payments
5DXd ADCs Upfront and Milestone Payments (Unit: Bn JPY) FY2024 Q1 Total Asset Item YoY FY2024 Forecast YoY Results Consideration Upfront Payment 2.6 +0.1 10.2 +0.1 149.0 Regulatory Milestones 2.4 +0.3 9.4 -2.9 137.7 ENHERTU Quid Related Payment 0.3 0 1.2 0 17.2 Sales Milestone - - 56.2 +26.6 42.8 Up
Slide 36: Major R&D Milestones (ENHERTU)
Major R&D Milestones (ENHERTU®) As of Jul 2024 Target indication [phase, study FY2024 Project FY2025 name] H1 H2 • HER2+, adjuvant* • TLR anticipated [Ph3, DESTINY-Breast05] • HR+/HER2 low, chemo naive • Planned regulatory • Planned regulatory [Ph3, DESTINY-Breast06] filing**（JP/EU) filing**（US) BC
Slide 37: Major R&D Milestones (Dato-DXd)
Major R&D Milestones (Dato-DXd) As of Jul 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 combo • Study started [Ph3, TROPION-Lung10] • 1L, EGFR muta
Slide 38: Major R&D Milestones (HER3-DXd, I-DXd, DS-6000)
Major R&D Milestones (HER3-DXd, I-DXd, DS-6000) As of Jul 2024 Target indication FY2024 Project FY2025 [phase, study name] H1 H2 • EGFR mutated, 3L • CRL received (US) [Ph2, HERTHENA-Lung01] HER3-DXd NSCLC • EGFR mutated, 2L • TLR anticipated [Ph3, HERTHENA-Lung02] • 2L+ • TLR anticipated [Dose opti
Slide 39: Major R&D Milestones (Next Wave)
Major R&D Milestones (Next Wave) As of Jul 2024 Target indication FY2024 Project FY2025 [phase, study name] H1 H2 • r/r PTCL valemetostat • Approval (JP) [Registrational Ph2, VALENTINE-PTCL01] mirogabalin • DPNP • Approved (CN) • COVID-19 mRNA vaccine (mutant strain), • Regulatory decision Children
Slide 40: Major R&D Pipeline: 5DXd ADCs
Major R&D Pipeline: 5DXd ADCs As of Jul 2024 Phase 1 Phase 2 Phase 3 (US/EU/Asia) HER2+ BC 2L+/1L (JP/US/EU/Asia) NSCLC (w/o AGA, (CN) HER2 expressing solid tumors (JP/US/EU/Asia) HER2+ BC (JP/US/EU/Asia) PD-L1 high non-squamous (JP/US/EU/Asia) in prep 1 DESTINY-Breast07 pembrolizumab combo) DESTINY
Slide 41: Major R&D Pipeline: Next Wave
Major R&D Pipeline: Next Wave As of Jul 2024 Phase 1 Phase 2 Phase 3 Regulatory phase DS-1055 (JP/US) DS-7011 (JP/US/EU/Asia) Valemetostat (EU) Pexidartinib (JP/Asia) DS-5670 (JP) Anti-GARP antibody Anti-TLR7 antibody EZH1/2 inhibitor CSF-1/KIT/FLT3 inhibitor COVID-19 mRNA vaccine (mutant strain), C
Slide 42: 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 42
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