Chugai Pharmaceutical Co., Ltd. · TSE:4519
Chugai Pharmaceutical — Q2 2025 Earnings Presentation
47 slides from Chugai Pharmaceutical's earnings presentation, Jul 24, 2025
Slide 1: Conference on FY2025.12 Q2 Financial Results
Conference on FY2025.12 Q2 Financial Results 24 July 2025 CHUGAI PHARMACEUTICAL CO., LTD.
Slide 2: Important Reminder
Important Reminder Forward-Looking Statements This presentation may include forward-looking statements pertaining to the business and prospects of Chugai Pharmaceutical Co., Ltd. (the “Company”). These statements reflect the Company’s current analysis of existing information and trends. Actual resul
Slide 3: Agenda
Agenda 01 FY2025 Q2 Overview President & CEO Dr. Osamu Okuda Executive Vice President, Head of Project & 02 Overview of Development Pipeline Lifecycle Management Unit Tsukasa Kusano FY2025 Q2 Consolidated Financial 03 Director, Executive Vice President & CFO Overview(Core) Iwaaki Taniguchi 3
Slide 4: FY2025 Q2 Overview
FY2025 Q2 Overview President & CEO Dr. Osamu Okuda
Slide 5: Financial Overview
FY2025 Q2 Overview Financial Overview ◼ Financial results with increased revenue and profit, driven by increase in both domestic and overseas sales ◼ Expecting to achieve the full year forecast, based on the steady progress in the first half of the fiscal year 2024 2025 2025 ◼ Domestic sales increas
Slide 6: Topline Overview
FY2025 Q2 Overview Topline Overview Overseas sales 【Billions of JPY】 +19.7 Export unit Sales +7.5 -7.8 ◼ Domestic sales price volume etc. Increased YoY due to significant ROY/PS Other Domestic sales income operating increase in new products +6.1 income Phesgo and PiaSky, and the Other revenue mainst
Slide 7: R&D Overview
FY2025 Q2 Overview R&D Overview ◼ Milestones in the first half of 2025 progressed favorably, such as the successful P3 trial of orforglipron and PoC confirmation in NXT007, which are pivotal projects for revenue contribution ◼ As a medium to long-term management decision focused on agile and strateg
Slide 8: Accelerating Overall Early Development Through Agile and Strategic Resource Allocation
FY2025 Q2 Overview Accelerating Overall Early Development Through Agile and Strategic Resource Allocation ◼ Since the start of TOP I 2030, early-stage development projects have been enhanced through RED SHIFT ◼ Based on the data obtained so far and the current portfolio situation, we have prioritize
Slide 9: A Robust Mid-size Molecule Portfolio
FY2025 Q2 Overview A Robust Mid-size Molecule Portfolio ◼ LUNA18: Oral absorption and inhibitory activity against the RAS signaling pathway* in clinical settings have been confirmed. Meanwhile, the decision to concentrate development efforts on AUBE00 was determined based on its competitive advantag
Slide 10: Decision to Construct a New Research Building 'UKX' at Ukima Site
FY2025 Q2 Overview Decision to Construct a New Research Building 'UKX' at Ukima Site ◼ Strengthen manufacturing process development capabilities for small, mid-size molecule drugs and biopharmaceuticals • As high-value-added projects applying Chugai's proprietary technologies are increasing, we aim
Slide 11: Summary
FY2025 Q2 Overview Summary ◼ Financial results with increased revenue and profit, driven by increase in both domestic and overseas sales. Expecting to achieve the full year forecast, based on the steady progress in the first half of the fiscal year ◼ Milestones in the first half of 2025 progressed f
Slide 12: Overview of Development Pipeline
Overview of Development Pipeline Executive Vice President, Head of Project & Lifecycle Management Unit Tsukasa Kusano
Slide 13: Q2 Topics (1/2)
Overview of Development Pipeline Q2 Topics (1/2) As of July 24, 2025 Launched Evrysdi Addition of dosage form (tablet) May 2025 (Japan) Adult patients with KRAS-mutated recurrent low-grade serous ovarian AVMAPKITM* cancer who have received prior systemic therapy (combination with FAK May 2025 (U.S.)
Slide 14: Q2 Topics (2/2)
Overview of Development Pipeline Q2 Topics (2/2) As of July 24, 2025 Phase III TALENTACE study (unresectable hepatocellular carcinoma) : Met one Tecentriq + Avastin of the primary endpoints (TACE PFS) May 2025 Readout Phase II RAMP 205 study (pancreatic ductal adenocarcinoma): Positive results AVMAP
Slide 15: 2025: Key R&D Milestones
Overview of Development Pipeline 2025: Key R&D Milestones As of July 24, 2025 Product Indication / Study name Progress Projects to be Elevydis Duchenne muscular dystrophy (ambulatory) Approved Approved Vabysmo angioid streaks Approved PiaSky COMMUTE-a study*: atypical hemolytic uremic syndrome (aHUS
Slide 16: NXT007: P1/2 Study for Severe Hemophilia A Without Inhibitors
Overview of Development Pipeline NXT007: P1/2 Study for Severe Hemophilia A Without Inhibitors ◼ First clinical data of NXT007 in people with hemophilia A. Hemlibra-naïve people enrolled ◼ In the high dose cohorts (B-3, B-4), plasma concentrations reached the predicted normal range of FVIII– equival
Slide 17: AUBE00 (Pan-KRAS Inhibitor)
Overview of Development Pipeline AUBE00 (Pan-KRAS Inhibitor) ◼ Second clinical-stage project applying mid-size molecule technology. Phase 1 trial initiated for solid tumors. ◼ Expecting superior efficacy compared to the pan-RAS inhibitor LUNA18, resulting from a wide therapeutic window based on KRAS
Slide 18: ROSE12: Anti-CTLA-4 Switch Antibody
Overview of Development Pipeline ROSE12: Anti-CTLA-4 Switch Antibody ◼ ROSE12 is expected to have a wide therapeutic window, and NK: natural killer its phase 1 trial for solid tumors is currently underway MΦ: macrophage TME: tumor microenvironment No drug activation (Switch OFF) Drug activation→Effe
Slide 19: Portfolio of Each Modality
Overview of Development Pipeline Portfolio of Each Modality As of July 24, 2025 Drug Discovery Pre-clinical development Clinical Launched Enspryng (MOGAD, AIE, TED/P3 Actemra Antibody drugs, cellular and gene therapy products NXT007 DMD/P2) Hemlibra DONQ52 PiaSky RAY121 (aHUS/P3, SCD/P2) Enspryng GC
Slide 20: Projected Submissions (Phase II & Later Programs and Products)
Overview of Development Pipeline Projected Submissions (Phase II & Later Programs and Products) NME Line extension As of July 24, 2025 Filed In-house new entry TECENTRIQ LUNSUMIO+ In-licensed (Roche) POLIVY CELLCEPT (RG7446) (RG7828+RG7596) Refractory nephrotic aHUS: atypical hemolytic uremic syndro
Slide 21: Projects under Development (1/2)
Overview of Development Pipeline Projects under Development （1/2） As of July 24, 2025 Phase I Phase II Phase III Filed GC33 / codrituzumab RG7421 / RG6114 / AF802 (RG7853) / Alecensa RG6171 /giredestrant AF802 (RG7853) / - HCC cobimetinib inavolisib - NSCLC (stage III)* - BC (adjuvant) Alecensa ALPS
Slide 22: Projects under Development (2/2)
Overview of Development Pipeline Projects under Development（2/2） As of July 24, 2025 Phase I Phase II Phase III Filed RG7935 / prasinezumab GYM329 (RG6237) / emugrobart SA237 (RG6168) / RG6356 / Elevydis - Parkinson's disease - SMA Enspryng - DMD* (non- RG6102/trontinemab (combination with Evrysdi)
Slide 23: Advance Hemlibra into Global PhIII Development for von Willebrand Disease (VWD)
Overview of Development Pipeline Advance Hemlibra into Global PhIII Development for von Willebrand Disease (VWD) ◼ Hemlibra is expected to prevent bleeds for people with Type 3 VWD due to its mode of action Function of VWF ◼ von Willebrand factor (VWF) is a plasma protein that mediates platelet Plat
Slide 24: Small Molecule Drug Discovery: Portfolio
Overview of Development Pipeline Small Molecule Drug Discovery: Portfolio As of July 24, 2025 In-house molecule MINT91 Alecensa Alecensa (Solid (Maintenance (NSCLC, NSCLC tumors/ treatment of adjuvant) NSCLC(stage Ⅲ) P1) after Edirol chemoradiotherapy REVN24 /P3) (Osteoporosis) (Acute disease/P1) Ox
Slide 25: Mid-Size Molecule Drug Discovery: Portfolio
Overview of Development Pipeline Mid-Size Molecule Drug Discovery: Portfolio As of July 24, 2025 Chronic Cancer Cancer Cancer disease AUBE00 (pan-KRAS) Chronic Cancer disease Acute Chronic disease Cancer disease Chronic Cancer disease Drug Discovery Pre-clinical Clinical development 25
Slide 26: Antibody Drug, Cellular and Gene Therapy: Portfolio
Overview of Development Pipeline Antibody Drug, Cellular and Gene Therapy: Portfolio As of July 24, 2025 Enspryng Actemra Established technologies NXT007 (MOGAD, AIE, (Rheumatoid (Hemophilia A/P1/2) TED/P3, DMD/P2) arthritis etc.) RAY121(Auto- Hemlibra PiaSky immune (Hemophilia A (aHUS/P3, disease/P
Slide 27: Advances in Major Chugai Originated Projects Out-Licensed to 3rd Parties (1/2)
Overview of Development Pipeline Advances in Major Chugai Originated Projects Out-Licensed to 3rd Parties (1/2) As of July 24, 2025 Generic name/ Mode of Granted rights to Development Licensee Indication Stage Progress Action licensee code ⚫ U.S. FDA BTD (recurrent LGSOC in combination with defactin
Slide 28: Advances in Major Chugai Originated Projects Out-Licensed to 3rd Parties (2/2)
Overview of Development Pipeline Advances in Major Chugai Originated Projects Out-Licensed to 3rd Parties (2/2) As of July 24, 2025 Generic name/ Mode of Granted rights to Development Licensee Indication Stage Progress Action licensee code Overseas: Atopic ⚫ Obtained U.S. FDA approval in Dec 2024 An
Slide 29: FoundationOne CDx Cancer Genomic Profile - Companion diagnostic indications
Overview of Development Pipeline FoundationOne CDx Cancer Genomic Profile -Companion diagnostic indications- As of July 24, 2025 Alterations Cancer type Relevant drugs Activating EGFR alterations afatinib maleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate, dacomitinib hydrate EGFR exo
Slide 30: FoundationOne Liquid CDx Cancer Genomic Profile
Overview of Development Pipeline FoundationOne Liquid CDx Cancer Genomic Profile -Companion diagnostic indications- As of July 24, 2025 Alterations Cancer type Relevant drugs Activating EGFR alterations afatinib maleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate EGFR exon 20 T790M alt
Slide 31: FY2025 Q2 Consolidated Financial Overview (Core)
FY2025 Q2 Consolidated Financial Overview(Core) Director, Executive Vice President & CFO Iwaaki Taniguchi
Slide 32: P/L Jan – Jun (Year on Year)
FY2025 Q2 Consolidated Financial Overview (Core) P/L Jan – Jun (Year on Year) Domestic sales Increase due to significant growth of new products and (Billions of JPY) 2024 2025 Growth mainstay products, despite decrease due to the NHI Revenue 552.9 578.5 + 25.6 + 4.6% drug price revisions and the mar
Slide 33: Sales Jan – Jun (Year on Year)
FY2025 Q2 Consolidated Financial Overview (Core) Sales Jan – Jun (Year on Year) ( ): Actual sales in FY2025 (Billions of JPY) Sales by Disease Area, Sales by Product, %: Year-on-year percentage change Year on Year Year on Year +25.9, +5.3% (150.7） (86.9） (6.3） (15.4） Overseas (13.0） (12.0） +19.7, +7
Slide 34: Export of Hemlibra and Actemra to Roche
FY2025 Q2 Consolidated Financial Overview (Core) Export of Hemlibra and Actemra to Roche (Billions of JPY) * : Remaining year forecast 2024 2025 2024 2025 Hemlibra Actemra 34
Slide 35: Operating Profit Jan – Jun (Year on Year)
FY2025 Q2 Consolidated Financial Overview (Core) Operating Profit Jan – Jun (Year on Year) Overseas sales (Billions of JPY) Decrease in Increase in +19.7 other revenue cost of sales Increase in -0.3 various costs and decrease -15.0 in other Domestic sales +18.0 operating +6.1 income Export unit -1.5
Slide 36: Structure of Costs and Profit by Quarter
FY2025 Q2 Consolidated Financial Overview (Core) Structure of Costs and Profit by Quarter (Billions of JPY) Year on Year (vs. 2024 Q2) % of Revenue (% of sales for Cost to sales ratio: increase due to a change in product mix, etc. cost of sales) R&D: increase due to investments in research and early
Slide 37: Structure of Revenue by Quarter
FY2025 Q2 Consolidated Financial Overview (Core) Structure of Revenue by Quarter (Billions of JPY) % of Revenue Year on Year (vs. 2024 Q2) Domestic sales: increase due to growth of new products and Other revenue mainstay products Overseas sales: decrease due to the timing of shipment of Hemlibra Oth
Slide 38: P/L Jan – Jun (vs. Forecast)
FY2025 Q2 Consolidated Financial Overview (Core) P/L Jan – Jun (vs. Forecast) Actual Forecast 2024 Domestic sales (Billions of JPY) 2025 2025 Steady progress in mainstay products and new Progress Progress* products Jan - Jun Jan - Dec Revenue 578.5 1,190.0 48.6% 47.2% Overseas sales Sales 511.4 1,01
Slide 39: Sales Jan – Jun (vs. Forecast)
FY2025 Q2 Consolidated Financial Overview (Core) Sales Jan – Jun (vs. Forecast) Actual Forecast 2024 Actual Forecast 2024 (Billions of JPY) 2025 2025 (Billions of JPY) 2025 2025 Progress Progress * Progress Progress * Jan - Jun Jan - Dec Jan - Jun Jan - Dec Sales 511.4 1,018.0 50.2% 48.7% Specialty
Slide 40: Impact from Foreign Exchange Jan – Jun
FY2025 Q2 Consolidated Financial Overview (Core) Impact from Foreign Exchange Jan – Jun vs.2024 vs.2025 2024 2025 2025 2025 2025 Actual rate Forecast rate Exchange Actual Forecast Actual Market Forecast (Billions of JPY) Rate rate*2 rate rate*2 average rate Jan - Jun Jan - Jun Jan -Jun rate*3 (JPY)
Slide 41: Financial Position (vs. 2024 Year End)
FY2025 Q2 Consolidated Financial Overview (Core) Financial Position (vs. 2024 Year End) (Billions of JPY) Total assets 2,208.4 + 69.9 2,278.3 Decrease in net working capital Total liabilities -306.9 +13.7 -293.2 Increase in accounts payable, etc., despite 1,901.5 Total net assets 1,985.1 decrease in
Slide 42: Net Cash (vs. 2024 Year End)
FY2025 Q2 Consolidated Financial Overview (Core) Net Cash (vs. 2024 Year End) (Billions of JPY) Operating profit after adjustment *1 +289.8 Operating profit *1 +273.3 Total investment Depreciation, amortization and impairment *1 +16.1 Income tax +16.1 -69.1 payable, etc. Net effect Decrease in net w
Slide 43: Current Status / Plan for Major Investments
FY2025 Q2 Consolidated Financial Overview (Core) Current Status / Plan for Major Investments Planned investment ～2024 2025 2026 2027 2028 2029 2030～ Period* Investment Total amount Unit to-date Utsunomiya plant UT3: Manufacture bio drug substance for middle to later- stage clinical 37.4 29.9 billion
Slide 44: P/L Jan – Jun (Non-core adjustment)
FY2025 Q2 Consolidated Financial Overview (Core) P/L Jan – Jun (Non-core adjustment) Non-core items Non-core items IFRS Core (Billions of JPY) Intangible results Others results Factors affected operating profit assets Revenue 578.5 578.5 Intangible assets Sales 511.4 511.4 Amortization +0.8 Other re
Slide 45: Summary of Chugai Originated Global Products
FY2025 Q2 Consolidated Financial Overview (Core) Summary of Chugai Originated Global Products (Billions of JPY) FY2025 Product (Billions of JPY) FY2025 Q2 Results Y on Y Comments Forecast Domestic: 29.1 +6.2% 59.4 • Japan: Sales increased year on year as domestic market share steadily increased. Ove
Slide 46: Contacts
Contacts Corporate Communications Dept. For Media: Media Relations Group Tel： +81 (0)3-3273-0881 E-mail： pr@chugai-pharm.co.jp Person in Hideki Sato, Naoki Kouzai, Atsuki Hirano, Ikue Miyazawa, charge： Kaho Izumi For Investors: Investor Relations Group Tel： +81 (0)3-3273-0554 E-mail： ir@chugai-pharm
Slide 47: INNOVATION BEYOND IMAGINATION
INNOVATION BEYOND IMAGINATION (OJ! CHUGAI PHARMACEUTICAL A member of the Roche group
Chugai Pharmaceutical — Q2 2025 Earnings Presentation on 6ix