Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — J.P. Morgan Healthcare Conference 2022

35 slides from Kyowa Kirin's conference presentation, Jan 10, 2022

  1. Slide 1: Delivering Life-changing Value as a Global Specialty Pharma

    Delivering Life‐changing Value as a Global Specialty Pharma J.P. Morgan Healthcare Conference January 10, 2022 Masashi Miyamoto, Ph.D. Representative Director of the Board, President and Chief Executive Officer

  2. Slide 2: Forward-looking statements disclaimer

    This document contains certain forward‐looking statements relating to such items as the Company’s forecasts, targets and plans (including those of its domestic and overseas subsidiaries). These forward‐ looking statements are based upon information available to the Company at the present time and up

  3. Slide 3: Agenda

    Agenda 4 Who We Are 12 Global Strategic Products Driving Our Growth 18 Next‐generation Strategic Products 30 Outlook for the Future 3 © Kyowa Kirin Co., Ltd

  4. Slide 4: Who We Are

    Who We Are 4 © Kyowa Kirin Co., Ltd.

  5. Slide 5: Vision

    Vision Provide Our New Vision toward 2030 pharmaceuticals for unmet medical needs Kyowa Kirin will realize the successful creation and delivery of life‐changing value that ultimately makes people smile, as a Japan‐based Global Retain the trust Specialty Pharmaceutical company built of society on the

  6. Slide 6: Overview

    Overview 5,423 ¥318.4 billion Valuable Annual consolidated employees revenue worldwide in 2020 39 countries/ regions 48 ％ 152 ％ Over 50 Pharmaceutical Extensive market reach, Overseas revenue Sales growth for the with a presence ratio three global strategic Strengths in products on the worldwide in

  7. Slide 7: Global Network

    Global Network EMEA 20 companies Sales Breakdown by Customer Region Japan 4 companies (FY2020) Asia 9.7% Japan 52.3% Europe 15.2% Overseas North America Revenue 6 48% companies Asia and Oceania 8 companies Americas As of Dec 31, 2020 22.7% 7 © Kyowa Kirin Co., Ltd.

  8. Slide 8: History

    History 1907 1984 1990 1997 Kirin A joint venture ESPO® Research Human antibody Brewery Kirin‐Amgen launched leading to producing founded founded with Crysvita technology Amgen began established 2018 2019 2020 2008 Kyowa Hakko Kirin (now Kyowa Kirin) founded Crysvita Nourianz Poteligeo launched laun

  9. Slide 9: Key Marketed Products

    Key Marketed Products Nephrology Oncology Immunology/Allergy Central Nervous System Others ｚ Erythropoiesis Stimulating Agent Anti‐CCR4 mAb Anti‐allergic agent Adenosine A2AR antagonist Anti‐FGF23 mAb Japan and Asia Japan, US and EU Japan and Asia Japan and US Japan, US*2 and EU Calcium receptor ago

  10. Slide 10: Proprietary Technologies for Life-changing Value Creation

    Proprietary Technologies for Life‐changing Value Creation KHK4083/AMG 451 POTELLIGENT® Technology 100 Fucose An ADCC‐enhancing technology Antibody‐dependent Antibodies Potelligent® 80 that realizes effective target cell cellular cytotoxicity (low/no fucose) ADCC activity (%) elimination by (ADCC) (2

  11. Slide 11: Next-Generation Technologies for Life-Changing Value Creation

    Next‐Generation Technologies for Life‐Changing Value Creation Bispecific Antibody Technology Drug Discovery Collaborations  Selection of linkers derived from Immunoglobulin (Ig)  Revolutionary small molecule drug discovery and the common sequence of L Chains (with Axcelead)  Versatility equivalen

  12. Slide 12: Global Strategic Products Driving Our Growth

    Global Strategic Products Driving Our Growth 12 © Kyowa Kirin Co., Ltd.

  13. Slide 13: Strong Growth of Global Brands (G3B)

    Strong Growth of Global 3 Brands (G3B) Crysvita billions (Burosumab, an anti‐FGF23 fully human monoclonal antibody) of yen X‐linked hypophosphatemia (XLH) Tumor‐induced osteomalacia (TIO) Revenue 351.0 305.8 318.4 117.8 Sales revenue Poteligeo 271.5 Sales from G3B 55.1 83.8 (Mogamulizumab, an anti‐C

  14. Slide 14: Crysvita

    Crysvita Burosumab, an anti‐FGF23 fully human monoclonal antibody 2000 2013 2018 2019 2020 2023 Cloning of Identify Collaborate with Launch in Launch in Launch in To initiate own FGF23 cDNA FGF23 Function Ultragenyx EU (peds) & US*1 EU (adults) Japan sales in US Annual sales growth*2 (NA+EMEA+JP) Nu

  15. Slide 15: Crysvita: Global Evidence Generation Project

    Crysvita Burosumab, an anti‐FGF23 fully human monoclonal antibody Global Evidence Generation Project Europe Asia Americas XLH Registry SUNFLOWER DMP* Medical Insights Generating Real World Evidence * Disease Monitoring Program https://xlhlink.eu/ 15 © Kyowa Kirin Co., Ltd.

  16. Slide 16: Poteligeo

    Poteligeo Mogamulizumab, an anti‐CCR4 humanized antibody 2012 2018 2020 Establish Launch in Launch in Launch in POTTELIGENT® Japan US EU technology  The first glyco‐engineered antibody to reach Annual sales growth* (NA+EMEA+JP) the market [Bn JPY] 19.3  Indications US EU JP 12.8 13.6 ATL MF MF PTC

  17. Slide 17: Nourianz/Nouriast

    Nourianz/Nouriast Istradefylline, an Adenosine A2A receptor antagonist 1994 2013 2019 2026 Discovery of Launch in Launch in Next generation A2AR antagonist Istradefylline Japan US KW‐6356 to be launched Annual sales growth (NA+JP)  MOA (Simple illustration)  Indications [Bn JPY] Levodopa replaces

  18. Slide 18: Next-generation Strategic Products

    Next‐generation Strategic Products 18 © Kyowa Kirin Co., Ltd.

  19. Slide 19: Next-generation Strategic Products

    Next‐generation Strategic Products Approval Total addressable No. of Country / region*1 Indication*2 year*3 patients*5 As of Feb 4, 2021 market*4 KHK4083/ NA/EU/JP Atopic dermatitis 2025/2026 ★ ★★ 16,000K AMG 451 KW‐6356 NA/EU/JP Parkinson’s disease 2025 ★ ★★ 3,500K ME‐401 ★ ★★ Follicular lymphoma N

  20. Slide 20: KHK4083/AMG 451 targets OX40 as a potential novel target for AD treatment

    KHK4083/AMG 451 targets OX40 as a potential novel target for AD treatment Naïve T cells TCR CD28 Activation of Th2 and other T‐cell subsets is central in MHC I B7 atopic dermatitis (AD) Activated APC Primed T cell The OX40–OX40L axis plays a critical role in long‐lasting T‐cell responses KHK4083, mA

  21. Slide 21: KHK4083/AMG 451: Achieved Primary Endpoint in Phase 2 Study

    KHK4083/AMG 451: Achieved Primary Endpoint in Phase 2 Study Phase 2 Study Design Primary Endpoint: % change from baseline in EASI score at W16 (LOCF, FAS) KHK4083 KHK4083 KHK4083 KHK4083 Screening Treatment A Treatment B Follow‐ 150 mg 600 mg 300 mg 600 mg (Up to Week 18) (Week 18‐Week 36) up Q4W Q4

  22. Slide 22: KHK4083/AMG 451: Durable EASI-75 Response Confirmed

    KHK4083/AMG 451: Durable EASI‐75 Response Confirmed Secondary Endpoint: EASI‐75 Responder Proportion Treatment period A Treatment period B (Placebo‐controlled period) (All groups received KHK4083) 65 KHK4083 150mg Q4W 60 KHK4083 600mg Q4W 55 KHK4083 300mg Q2W 50 KHK4083 600mg Q2W 45 40 / Placebo/KHK

  23. Slide 23: KHK4083/AMG 451: Collaboration with Amgen

    KHK4083/AMG 451: Collaboration with Amgen US Europe and Asia (ex. JP) JP  Amgen leads development  Amgen leads development Development  Kyowa Kirin leads development  Share development cost  Share development cost  Amgen commercializes and  Amgen commercializes and books sales books sales  K

  24. Slide 24: Zandelisib (ME-401): Clinical and Commercial Opportunity

    Zandelisib (ME‐401): Clinical and Commercial Opportunity >8,000 U.S. Patients Market Opportunity Zandelisib Opportunity With Relapsed/Refractory  PI3Kδ inhibitors deliver potent  Product attributes and novel Follicular Lymphoma efficacy, but utility limited by the treatment schedule could reset ex

  25. Slide 25: Zandelisib: Emerging Profile

    Zandelisib: Emerging Profile Cycles 1 and 2 Intermittent Dosing on Cycles ≥3 Phase 2 study (TIDAL) in patients with r/r FL Daily dosing Daily No therapy Zandelisib 8 wks 1 wk 3 wks Overall Response Rate Discontinuation Rate (ORR) 70.3% Due to Any Drug Related 9.9% 95% Cl (59.8, 79.5) Adverse Event C

  26. Slide 26: Zandelisib: Exploring Full Potential as Backbone Therapy

    Zandelisib: Exploring Full Potential as Backbone Therapy Zandelisib Zandelisib Other Zandelisib Single Agent + Rituximab Combinations  Ph 2 Study TIDAL in  Ph 3 Study COASTAL  + Zanubrutinib in FL and 3L+ FL and MZL in 2L+ FL and MZL MCL in 2L+  + R‐CHOP in DLBCL in 1L  Ph 2 Study K02 in 3L+ in

  27. Slide 27: Bardoxolone Methyl (RTA 402): Clinical and Commercial Opportunity

    Bardoxolone Methyl (RTA 402): Clinical and Commercial Opportunity Diabetes Patients  Glycemic Control Market Opportunity RTA 402 Opportunity  Blood Pressure Control under Treatment (Patient population:  Increasing diabetes patients  Novel MOA ‐ Nrf2 activation 7.7 million)*1  Protect renal func

  28. Slide 28: Bardoxolone Methyl: Increase GFR in CKD Patients with Type 2 Diabetes

    Bardoxolone Methyl: Increase GFR in CKD Patients with Type 2 Diabetes Phase 2 study (TSUBAKI) in CKD patients with Type 2 Diabetes Phase 3 study (AYAME) in DKD patients GFR GFR GFR Visit Visit Week BL 16 Placebo Off‐drug Placebo 15mg/day Off‐drug 15mg/day R R 10mg/day 10mg/day 5mg/day Bardoxolone me

  29. Slide 29: Expected News Flow in FY2022

    Expected News Flow in FY2022 As of Nov 1, 2021 Code Target disease 2022 generic name KHK4083/AMG 451 Atopic dermatitis P3 FPI P2b detailed data KW‐6356 Parkinson’s disease P3 FPI FL/MZL (2L, R combo) Enrollment ongoing ME‐401 iNHL (3L, mono) P2 Topline data Zandelisib CLL (Ven‐R combo) P2 FPI Alport

  30. Slide 30: Outlook for the Future

    Outlook for the Future ‐ Delivering Life‐changing Value as a GSP ‐ 30 © Kyowa Kirin Co., Ltd.

  31. Slide 31: Outlook toward 2030

    Outlook toward 2030 2025 2030 Accelerate Growth by Next‐ Generate Sustained Growth and Maximize the Value of G3B generation Global Products Achieve our New Vision for Kyowa Kirin KHK4083 KW‐6356 ME‐401 Expand Sales of Global Products to Drive Growth Generate Revenue from Existing Products and the La

  32. Slide 32: Life-changing Value as a GSP Strategy

    FY2021‐2025 Medium Term Business Plan Delivering Life‐changing Value as a GSP Our New Vision Strategy to Realize Address toward 2030 Financial Indexes our New Vision patient‐centric healthcare needs 10 % CAGR 10 % or higher To be or higher Strategy Targeting 18‐20 % to support active investment Prov

  33. Slide 33: Appendix

    Appendix 33 © Kyowa Kirin Co., Ltd.

  34. Slide 34: Stock Information (As of December 31, 2020)

    Stock Information (As of December 31, 2020) Stock Listing Principal Shareholders Tokyo Securities Code 4151 Transfer Agent of Common Stock Sumitomo Mitsui Trust Bank, Limited 1‐4‐1, Marunouchi, Chiyoda‐ku, Tokyo 100‐8233, Japan http://www.smtb.jp/personal/agency/index.html Number of Shares of Common

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