Slide 1: Conference on FY2024.12 Q1 Financial Results
Conference on FY2024.12 Q1 Financial Results Photo image CHUGAI PHARMACEUTICAL CO., LTD. 24 April 2024
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
Conference on FY2024.12 Q1 Financial Results Agenda 01 FY2024 Q1 Overview Dr. Osamu Okuda President & CEO 02 Overview of Development Pipeline Tsukasa Kusano Executive Vice President Head of Project & Lifecycle Management Unit 03 FY2024 Q1 Consolidated Financial Overview (Core) Iwaaki Taniguchi Direc
Slide 4: FY2024 Q1 Overview
FY2024 Q1 Overview Dr. Osamu Okuda President & CEO
Slide 5: Financial Overview
FY2024 Q1 Overview Financial Overview ◼ Significantly decreased in revenue due to the completion of supply of Ronapreve to the government and the NHI drug price revisions etc. ◼ Achieved high profitability, significantly surpassing last year, resulting in a slight decrease in profit ◼ Earnings forec
Slide 6: Summary of Chugai Originated Global Products
FY2024 Q1 Overview Summary of Chugai Originated Global Products ◼ Despite the BS impact on Actemra, we expect continued growth in overseas sales, primarily driven by Hemlibra ◼ We are dedicated to delivering the value that patients truly need through our unique, proprietary medicines Product (Billio
Slide 7: Introduction of New Management Members (Supervisory Responsibility)
FY2024 Q1 Overview Introduction of New Management Members (Supervisory Responsibility) Dr. Osamu Okuda Iwaaki Taniguchi Dr. Hitoshi Iikura Tetsuya Yamaguchi Junichi Ebihara Representative Director, Director, Executive Vice Director, Executive Vice Executive Vice President Executive Vice President Pr
Slide 8: Overview of Development Pipeline
Overview of Development Pipeline Tsukasa Kusano Executive Vice President, Head of Project & Lifecycle Management Unit
Slide 9: Q1 Topics (1/2)
Overview of Development Pipeline Q1 Topics (1/2) As of April 24, 2024 February 2024 (China) Piasky Paroxysmal nocturnal hemoglobinuria (PNH) March 2024 (Japan) Alecensa ALK-positive early-stage NSCLC (adjuvant) April 2024 (U.S.) Pruritus associated with atopic dermatitis Mitchga (children aged ≧6 an
Slide 10: Q1 Topics (2/2)
Overview of Development Pipeline Q1 Topics (2/2) As of April 24, 2024 RG6299(ASO Factor B) IgA nephropathy P1 study (February 2024) Initiation of RG6356/SRP-9001 Duchenne muscular dystrophy (Non-ambulatory) P3 study (March 2024) study glofitamab+Polivy Previously untreated large B-cell lymphoma P3 s
Slide 11: 2024: Key R&D Milestones
Overview of Development Pipeline 2024: Key R&D Milestones Underlined and bolded are new progress since February 1, 2024 Product Indication/Study name Progress crovalimab Paroxysmal nocturnal hemoglobinuria (Japan/EU/U.S.) Approved (Japan) Projects to be Alecensa NSCLC (adjuvant) (U.S./EU/Japan) Appr
Slide 12: Nemolizumab: Global Ph3 ARCADIA 1&2 and OLYMPIA LTE studies
Overview of Development Pipeline Nemolizumab: Global Ph3 ARCADIA 1&2 maintenance and OLYMPIA LTE studies revealed sustained improvement in pruritus as well as skin lesions*1, *2 Atopic dermatitis ARCADIA 1&2 Prurigo nodularis OLYMPIA LTE 100 ≥4-point improvement in Peak Pruritus ≥4-point improvement
Slide 13: ASO (AntiSense Oligonucleotide) Factor B (RG6299)
Overview of Development Pipeline ASO(AntiSense Oligonucleotide) Factor B (RG6299) Oligonucleotide therapeutics, selectively taken up by hepatocytes to inhibit complement factor B production • IgA nephropathy (IgAN) is characterized by persistent abnormalities in urinalysis such as glomerular hematur
Slide 14: Zilebesiran, an RNAi Therapeutic Agent as a New Modality
Overview of Development Pipeline Zilebesiran, an RNAi Therapeutic Agent as a New Modality RNAi is an RNA interference mechanism by which genes are naturally regulated in cells, and one of the innovative drugs based on RNAi is an siRNAs RNAi is a natural biological process that regulates gene express
Slide 15: About Zilebesiran
Overview of Development Pipeline About Zilebesiran ◼ Zilebesiran, an RNAi therapy for hypertension, achieve sustained suppression of angiotensinogen (AGT) expression and is expected to be a promissing solution to unmet medical needs in hypertensive patients with poor blood pressure control and a hig
Slide 16: Potential Market Sales of Main Projects
Overview of Development Pipeline Potential Market Sales of Main Projects Domestic Sales as of April 24, 2024 In-house Roche products Indications Domestics Sales*1 Peak Sales Year Changes from previous disclosure Indications Domestic Sale*1 Products LC, BC, HCC, Reschedule of the filing timing for He
Slide 17: Projected Submissions (Post PoC NMEs and Products)
Overview of Development Pipeline Projected Submissions (Post PoC NMEs and Products) as of April 24, 2024 NME Line extension Filed GAZYVA (RG7159) in-house Extra renal lupus ALECENSA mosunetuzumab (AF802/RG7853) CELLCEPT in-licensed (Roche) (RG7828) SSc-ILD : new entry : changes in submission year gl
Slide 18: Projects under Development (1/2)
Overview of Development Pipeline Projects under Development (1/2) As of April 24, 2024 Phase I Phase II Phase III Filed LUNA18 RG7421 / cobimetinib RG6396 / AF802 (RG7853) / Alecensa RG6058 / AF802 (RG7853) / Alecensa - Solid tumors - Solid tumors pralsetinib - NSCLC (stage III)* tiragolumab+RG7446
Slide 19: Projects under Development (2/2)
Overview of Development Pipeline Projects under Development (2/2) As of April 24, 2024 Phase I Phase II Phase III Filed DONQ52 SKY59(RG6107)/ RG7159 / Gazyva CellCept - Celiac disease crovalimab - Lupus nephritis - SSc-ILD ★ - Lupus nephritis - Pediatric nephrotic syndrome Immunology RAY121 RG6299 -
Slide 20: Enspryng: Generalized Myasthenia Gravis
Overview of Development Pipeline Enspryng: Generalized Myasthenia Gravis Ph III study (LUMINESCE): met primary endpoint, but did not reach our expectations 188 participants were randomized: 96 to satralizumab, 92 to placebo Week 24 difference: –1.02 0 (95% CI, –1.88, –0.16) p=0.0196 MG-ADL score (ad
Slide 21: 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 April 24, 2024 Generic Mode of name/develop Licensee Granted rights to licensee Indication Stage Progress Action ment code • US FDA BTD（recurrent LGSOC in combination with defactinib
Slide 22: 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 April 24, 2024 Generic Mode of name/develop Licensee Granted rights to licensee Indication Stage Progress Action ment code • In a phase 2 study, orforglipron achieved HbA1c reduction
Slide 23: FoundationOne CDx Cancer Genomic Profile - Companion diagnostic indications
Overview of Development Pipeline FoundationOne CDx Cancer Genomic Profile -Companion diagnostic indications- As of April 24, 2024 Alterations Cancer type Relevant drugs Activating EGFR alterations afatinib maleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate, dacomitinib hydrate EGFR ex
Slide 24: FoundationOne Liquid CDx Cancer Genomic Profile
Overview of Development Pipeline FoundationOne Liquid CDx Cancer Genomic Profile Companion diagnostic indications As of April 24, 2024 Alterations Cancer type Relevant drugs Activating EGFR alterations afatinib maleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate EGFR exon 20 T790M alte
Slide 25: FY2024 Q1 Consolidated Financial Overview (Core)
FY2024 Q1 Consolidated Financial Overview(Core) Iwaaki Taniguchi Executive Vice President & CFO
Slide 26: P/L Jan – Mar (Year on Year)
FY2024 Q1 Consolidated Financial Overview (Core) P/L Jan – Mar (Year on Year) (Billions of JPY) 2023 2024 Growth Domestic sales Decrease due to the absence of supply of Ronapreve to the Revenue 312.2 236.9 - 75.3 - 24.1% government recorded in the same period of the previous year, Sales 291.5 204.5
Slide 27: Sales Jan – Mar (Year on Year)
FY2024 Q1 Consolidated Financial Overview (Core) Sales Jan – Mar (Year on Year) Sales by Disease Area, Sales by Product, ( ): Actual sales in FY2024 (Billions of JPY) Year on Year Year on Year %: Year-on-year percentage change *included in Other products of Specialty 291.5 (-） Hemlibra(Overseas) (57
Slide 28: Operating Profit Jan – Mar (Year on Year)
FY2024 Q1 Consolidated Financial Overview (Core) Operating Profit Jan – Mar (Year on Year) (Billions of JPY) Decrease in sales （-87.0） Increase mainly due to one-time income Decrease in gross profit from sales -8.7 NHI drug price revision -5.1 Export unit price -0.2 -1.1 +11.8 Increase in R&D expens
Slide 29: Structure of Costs and Profit by Quarter
FY2024 Q1 Consolidated Financial Overview (Core) Structure of Costs and Profit by Quarter (Billions of JPY) % of Revenue (% of sales for cost of sales) Year on Year (vs. 2023 Q1) See the page “P/L Jan – Mar (Year on Year)” Cost of sales Quarter on Quarter (vs. 2023 Q4) Cost of sales ratio: improve d
Slide 30: Structure of Revenue by Quarter
FY2024 Q1 Consolidated Financial Overview (Core) Structure of Revenue by Quarter (Billions of JPY) % of Revenue Other revenue Year on Year (vs. 2023 Q1) See the page “P/L Jan – Mar (Year on Year)” Overseas sales Quarter on Quarter (vs. 2023 Q4) Domestic sales: decrease due to the difference of numbe
Slide 31: P/L Jan – Mar (vs. Forecast)
FY2024 Q1 Consolidated Financial Overview (Core) P/L Jan – Mar (vs. Forecast) Domestic sales Actual Forecast 2023 Progress in line with forecast of domestic sales (Billions of JPY) 2024 2024 (2023 progress excluding Ronapreve: 24.2%) Progress Progress* Jan - Mar Jan - Dec + Overseas sales Revenue 23
Slide 32: Sales Jan – Mar (vs. Forecast)
FY2024 Q1 Consolidated Financial Overview (Core) Sales Jan – Mar (vs. Forecast) Actual Forecast 2023 Actual Forecast 2023 (Billions of JPY) 2024 2024 (Billions of JPY) 2024 2024 Progress Progress * Progress Progress * Jan - Mar Jan - Dec Jan - Mar Jan - Dec Sales 204.5 922.0 22.2% 29.9% Specialty 47
Slide 33: Impact from Foreign Exchange Jan – Mar
FY2024 Q1 Consolidated Financial Overview (Core) Impact from Foreign Exchange Jan – Mar vs.2023 vs.2024 2023 2024 2024 2024 Actual rate Actual rate Exchange (Billions of JPY) Actual rate*2 Forecast rate Forecast rate Actual rate*2 Rate Jan - Mar Jan - Mar Jan - Dec Jan -Mar 【C】vs.【A】 【C】vs.【B】 (JPY)
Slide 34: Financial Position (vs. 2023 Year End)
FY2024 Q1 Consolidated Financial Overview (Core) Financial Position (vs. 2023 Year End) (Billions of JPY) Total assets 1,932.5 -34.7 1,897.8 Total liabilities -307.0 +51.3 -255.7 Decrease in net working capital 1,625.6 Total net assets 1,642.0 Decrease mainly due to a decrease in accounts +16.4 rece
Slide 35: Net Cash (vs. 2023 Year End)
FY2024 Q1 Consolidated Financial Overview (Core) Net Cash (vs. 2023 Year End) Total (Billions of JPY) investment Income tax -14.4 payable, etc. Operating profit after adjustment *1 +108.2 +44.1 -50.7 Dividends Operating profit *1 +99.9 DecreaseOperating paid in net free cash Depreciation, amortizati
Slide 36: Current Status / Plan for Major Investments
FY2024 Q1 Consolidated Financial Overview (Core) Current Status / Plan for Major Investments Planned investment Start of Planned ~2023 2024 2025 2026 2027 2028 2029~ Investment investment completion Total amount Unit to-date Fujieda plant FJ3: Manufacture APIs of small and mid-size molecule drugs fo
Slide 37: P/L Jan – Mar (Non-core adjustment)
FY2024 Q1 Consolidated Financial Overview (Core) P/L Jan – Mar (Non-core adjustment) Non-core items Non-core items (Billions of JPY) IFRS Core (Billions of JPY) Intangible results Others results Factors affected operating profit assets Revenue 236.9 236.9 Intangible assets Sales 204.5 204.5 Amortiza
Slide 38: Abbreviations
Conference on FY2024.12 Q1 Financial Results Abbreviations AD atopic dermatitis MIBC muscle-invasive bladder cancer adj adjuvant MM multiple myeloma aHUS atypical hemolytic uremic syndrome MOGAD myelin oligodendrocyte glycoprotein antibody–associated disease AIE autoimmune encephalitis nAMD neovascu
Slide 39: 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, Shumpei Yokoyama, Naoki Kouzai, charge： Ikue Miyazawa, Mari Otsuka For Investors: Investor Relations Group Tel： +81 (0)3-3273-0554 E-mail： ir@chugai-p
Slide 40: INNOVATION BEYOND IMAGINATION
INNOVATION BEYOND IMAGINATION