Chugai Pharmaceutical Co., Ltd. · TSE:4519

Chugai Pharmaceutical — Q3 2024 Earnings Presentation

41 slides from Chugai Pharmaceutical's earnings presentation, Oct 25, 2024

  1. Slide 1: Conference on FY2024.12 Q3 Financial Results

    Conference on FY2024.12 Q3 Financial Results Photo image CHUGAI PHARMACEUTICAL CO., LTD. 25 October 2024

  2. 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

  3. Slide 3: Agenda

    Conference on FY2024.12 Q3 Financial Results Agenda 01 FY2024 Q3 Overview Dr. Osamu Okuda President & CEO 02 Overview of Development Pipeline Tsukasa Kusano Executive Vice President Head of Project & Lifecycle Management Unit 03 FY2024 Q3 Consolidated Financial Overview (Core) Iwaaki Taniguchi Direc

  4. Slide 4: FY2024 Q3 Overview

    FY2024 Q3 Overview Dr. Osamu Okuda President & CEO

  5. Slide 5: Financial Overview

    FY2024 Q3 Overview Financial Overview  Revenue increased, as the increase of overseas sales and other revenue overwhelmed the decrease of domestic sales, and exceeded the original forecast  Operating profit and net income significantly increased YoY, and exceeded the original forecast  Full-year

  6. Slide 6: Topline Overview

    FY2024 Q3 Overview Topline Overview Other revenue Overseas sales +16.0 +64.8 Others  Domestic sales: 【billions of JPY】 Actemra ＋6.9 Other ＋21.2 Reflecting progress and revised ROY/PS operating projections for each product, including income income Phesgo, Polivy, Vabysmo, and Perjeta +4.4 +11.6 Heml

  7. Slide 7: Progress of Chugai Originated Products Supporting Short- to Mid-term Growth

    FY2024 Q3 Overview Progress of Chugai Originated Products Supporting Short- to Mid-term Growth  Steady development including global approval of PiaSky and NEMLUVIO®, and expanded indication of ALECENSA First option for Game Changer for New value in Major Chugai originated products under late- advan

  8. Slide 8: Overview of Development Pipeline

    Overview of Development Pipeline Tsukasa Kusano Executive Vice President, Head of Project & Lifecycle Management Unit

  9. Slide 9: Q3 Topics (1/2)

    Overview of Development Pipeline Q3 Topics (1/2) As of October 25, 2024 Adults and adolescents (12 years of age or older with a weight of 40 PiaSky kg and above) with paroxysmal nocturnal hemoglobinuria (PNH) who August 2024 (EU) are either new to, or have been previously treated with C5 inhibitors

  10. Slide 10: Q3 Topics (2/2)

    Overview of Development Pipeline Q3 Topics (2/2) As of October 25, 2024 SPYK04 (RAF-MEK molecular glue) Solid tumors: initiation of out-licensing activities Removed from Pipeline RG6139/tobemstomig Solid tumors: development discontinued EADV**: Long-term efficacy and safety in atopic dermatitis and

  11. Slide 11: 2024: Key R&D Milestones

    Overview of Development Pipeline 2024: Key R&D Milestones Underlined and bolded are new progress since July 25, 2024 Product Indication/Study name Progress PiaSky Paroxysmal nocturnal hemoglobinuria (Japan/EU/U.S.) Approved (Japan/U.S./EU) Projects to be Alecensa Non-small cell lung cancer (NSCLC) (

  12. Slide 12: NEMLUVIO: Prurigo Nodularis Early Onset and Long-term Efficacy

    Overview of Development Pipeline NEMLUVIO: Prurigo Nodularis Early Onset and Long-term Efficacy  Nemolizumab exhibited significant pruritus improvement as early as day 2 or 1 in OLYMPIA programs (top) and continuous improvement in pruritus and IGA0/1 up to 52 weeks in OLYMPIA LTE study (bottom) Sou

  13. Slide 13: NEMLUVIO: Atopic Dermatitis Early Onset and Long-term Efficacy

    Overview of Development Pipeline NEMLUVIO: Atopic Dermatitis Early Onset and Long-term Efficacy  Nemolizumab exhibited significant pruritus improvement as early as day 2 or 1 in ARCADIA programs (top) and continuous improvement in IGA0/1 and EASI-75 up to 56 weeks in ARCADIA LTE study (bottom) Sour

  14. Slide 14: RG6631 (Anti-TL1A Antibody)

    Overview of Development Pipeline RG6631 (Anti-TL1A Antibody)  With its novel mode of action, targeting suppression of inflammation and fibrosis by inhibiting TL1A, RG6631 has the potential to be a first-in-class and best-in-disease agent in inflammatory bowel disease*1 and to be applied in multiple

  15. Slide 15: Inavolisib (PI3K Inhibitor): Mode of Action

    Overview of Development Pipeline Inavolisib (PI3K Inhibitor): Mode of Action  Inavolisib is a highly potent, selective inhibitor of p110α, the catalytic subunit of PI3Kα. In addition, inavolisib promotes the degradation of mutated p110α (mutant degrader)  Inavolisib is a new targeted molecular age

  16. Slide 16: Global Phase 3 Study (INAVO120) of Inavolisib

    Overview of Development Pipeline Global Phase 3 Study (INAVO120) of Inavolisib  Expected to become a new standard molecular-targeted drug by combining CDK4/6 inhibitors and anti-estrogen drugs in advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation 【Study design】 【

  17. Slide 17: Projected Submissions (Post PoC NMEs and Products)

    Overview of Development Pipeline Projected Submissions (Post PoC NMEs and Products) as of October 25, 2024 Filed NME Line extension mosunetuzumab TECENTRIQ SRP-9001 VABYSMO in-house (RG7828) (RG7446) (RG6356) (RG7716) 3L Follicular lymphoma Alveolar soft part sarcoma DMD Angioid streaks in-licensed

  18. Slide 18: Projects under Development (1/2)

    Overview of Development Pipeline Projects under Development (1/2) As of October 25, 2024 Phase I Phase II Phase III Filed LUNA18 RG7421 / cobimetinib AF802 (RG7853) / Alecensa RG6171 / giredestrant RG7446 / Tecentriq - Solid tumors - Solid tumors - NSCLC (stage III)* - BC (adjuvant) - Alveolar soft

  19. Slide 19: Projects under Development (2/2)

    Overview of Development Pipeline Projects under Development (2/2) As of October 25, 2024 Phase I Phase II Phase III Filed DONQ52 RG7159 / Gazyva ASO factor B (RG6299) - Celiac disease - Lupus nephritis - IgA nephropathy Immunology - Pediatric nephrotic syndrome RAY121 - Extra renal lupus - Autoimmun

  20. Slide 20: 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 October 25, 2024 Generic Mode of name/develop Licensee Granted rights to licensee Indication Stage Progress Action ment code • U.S. FDA BTD（recurrent LGSOC in combination with defact

  21. Slide 21: 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 October 25, 2024 Generic Mode of name/develop Licensee Granted rights to licensee Indication Stage Progress Action ment code FDA BLA • FDA BLA / EMA MAA accepted in Feb 2024 + consor

  22. Slide 22: FoundationOne CDx Cancer Genomic Profile - Companion diagnostic indications

    Overview of Development Pipeline FoundationOne CDx Cancer Genomic Profile -Companion diagnostic indications- As of October 25, 2024 Alterations Cancer type Relevant drugs Activating EGFR alterations afatinib maleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate, dacomitinib hydrate EGFR

  23. Slide 23: FoundationOne Liquid CDx Cancer Genomic Profile

    Overview of Development Pipeline FoundationOne Liquid CDx Cancer Genomic Profile Companion diagnostic indications As of October 25, 2024 Alterations Cancer type Relevant drugs Activating EGFR alterations afatinib maleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate EGFR exon 20 T790M al

  24. Slide 24: FY2024 Q3 Consolidated Financial Overview (Core)

    FY2024 Q3 Consolidated Financial Overview(Core) Iwaaki Taniguchi Executive Vice President & CFO

  25. Slide 25: P/L Jan – Sep (Year on Year)

    FY2024 Q3 Consolidated Financial Overview (Core) P/L Jan – Sep (Year on Year) Domestic sales (Billions of JPY) 2023 2024 Growth Decrease due to the absence of supply of Ronapreve (81.2 billion Revenue 837.6 868.5 + 30.9 + 3.7% JPY) to the government recorded in the same period of the previous year,

  26. Slide 26: Sales Jan – Sep (Year on Year)

    FY2024 Q3 Consolidated Financial Overview (Core) Sales Jan – Sep (Year on Year) (Billions of JPY) Sales by Disease Area, Sales by Product, ( ): Actual sales in FY2024 Year on Year Year on Year %: Year-on-year percentage change +8.2, +1.1% *included in Other products of Specialty 742.1 750.3 (-） (253

  27. Slide 27: Operating Profit Jan – Sep (Year on Year)

    FY2024 Q3 Consolidated Financial Overview (Core) Operating Profit Jan – Sep (Year on Year) (Billions of JPY) -21.1 Increase in Domestic sales Overseas sales +76.1 operating expenses and decrease in NHI drug price +22.7 Increase in other operating revisions cost of sales income Impact of sales Increa

  28. Slide 28: Structure of Costs and Profit by Quarter

    FY2024 Q3 Consolidated Financial Overview (Core) Structure of Costs and Profit by Quarter (Billions of JPY) Year on Year (vs. 2023 Q3) % of Revenue (% of sales for Cost of sales ratio: Cost to sales ratio improved due to a cost of sales) change in product mix, etc. R&D: same level as the same period

  29. Slide 29: Structure of Revenue by Quarter

    FY2024 Q3 Consolidated Financial Overview (Core) Structure of Revenue by Quarter (Billions of JPY) Year on Year (vs. 2023 Q3) % of Revenue Domestic sales: decrease due to the market penetration of generic drugs and the NHI drug price revisions, etc. Overseas sales: significant increase in sales of H

  30. Slide 30: P/L Jan – Dec (Revision of Forecast)

    FY2024 Q3 Consolidated Financial Overview (Core) P/L Jan – Dec (Revision of Forecast) Original Revised Main reasons for revision: Forecast Forecast Domestic sales (Billions of JPY) Revision Year-on-Year 2024 2024 Reflects the progress and revised Jan - Dec Jan - Dec assumptions for each product Reve

  31. Slide 31: Sales Jan – Dec (Revision of Forecast)

    FY2024 Q3 Consolidated Financial Overview (Core) Sales Jan – Dec (Revision of Forecast) Original Revised Main reasons for revision: (Billions of JPY) Forecast Forecast Oncology -0.5 (Billions of JPY) Revision Year-on-Year 2024 2024 Polivy -3.4 Jan - Dec Jan - Dec Perjeta -2.1 Sales 922.0 986.0 +64.0

  32. Slide 32: Impact from Foreign Exchange Jan – Sep

    FY2024 Q3 Consolidated Financial Overview (Core) Impact from Foreign Exchange Jan – Sep vs.2023 vs.2024 2023 2024 2024 2024 2024 Actual rate Original Actual Original Actual Original Revised Exchange Forecast Forecast (Billions of JPY) Forecast rate rate*2 Forecast rate*2 Rate rate rate rate 【C】vs.【A

  33. Slide 33: Financial Position (vs. 2023 Year End)

    FY2024 Q3 Consolidated Financial Overview (Core) Financial Position (vs. 2023 Year End) (Billions of JPY) Total assets 1,932.5 +137.2 2,069.7 Increase in net working capital Total liabilities -307.0 ＋38.6 -268.4 Increase due to an increase in accounts receivable and a decrease in accounts payable pu

  34. Slide 34: Net Cash (vs. 2023 Year End)

    FY2024 Q3 Consolidated Financial Overview (Core) Net Cash (vs. 2023 Year End) (Billions of JPY) Total investment Income tax Operating profit after adjustment *1 +444.5 -38.0 -59.1 payable, etc. Operating profit *1 +418.6 Increase in net -109.2 Dividends Depreciation, amortization and impairment *1 +

  35. Slide 35: P/L Jan – Sep (Non-core adjustment)

    FY2024 Q3 Consolidated Financial Overview (Core) P/L Jan – Sep (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 Intangible assets Revenue 868.5 868.5 Amortization +1.2 Sales 75

  36. Slide 36: P/L Jan – Sep (vs. Forecast)

    FY2024 Q3 Consolidated Financial Overview (Core) P/L Jan – Sep (vs. Forecast) Original Actual Reivised Forecast 2023 Forecast (Billions of JPY) 2024 2024 2024 Progress Progress* Jan - Jan - Dec Jan - Dec Revenue 868.5 1,070.0 1,150.0 75.5% 75.4% Sales 750.3 922.0 986.0 76.1% 76.2% Domestic 331.7 454

  37. Slide 37: Sales Jan – Dec (Revision of Forecast)

    FY2024 Q3 Consolidated Financial Overview (Core) Sales Jan – Dec (Revision of Forecast) Original Original Actual Forecast Reivised Forecast 2023 Actual Forecast Reivised Forecast 2023 (Billions of JPY) (Billions of JPY) 2024 2024 2024 2024 2024 2024 Progress Progress * Progress Progress * Jan - Sep

  38. Slide 38: Summary of Chugai Originated Global Products

    FY2024 Q3 Consolidated Financial Overview (Core) Summary of Chugai Originated Global Products * “Export” in the table includes Taiwan local sales in the Chugai territory. ‘Overseas local’ refers to overseas local sales by Roche, and Year on Year (%) is on a constant exchange rate basis. BS: biosimil

  39. Slide 39: Current Status / Plan for Major Investments

    FY2024 Q3 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

  40. Slide 40: 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

  41. Slide 41: INNOVATION BEYOND IMAGINATION

    INNOVATION BEYOND IMAGINATION

Chugai Pharmaceutical — Q3 2024 Earnings Presentation on 6ix