Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — Q2 2019 Earnings Presentation

23 slides from Kyowa Kirin's earnings presentation, 2019

  1. Slide 1: Results Presentation Fiscal 2019 Second Quarter

    Results Presentation Fiscal 2019 Second Quarter

  2. Slide 2: Agenda

    Agenda Q2 Summary & Financial Review R&D Review Business Topics President & CEO Masashi Miyamoto, Ph.D Q&A President & CEO Masashi Miyamoto, Ph.D Executive Officer, Head of R&D Division Mitsuo Satoh, Ph.D Executive Officer, Head of Finance Dept Motohiko Kawaguchi © Kyowa Kirin Co., Ltd. 2

  3. Slide 3: This document contains certain forward‐looking statements relating to such items as the company’s (including

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

  4. Slide 4: Q2 Summary & Financial Review

    Q2 Summary & Financial Review © Kyowa Kirin Co., Ltd. 4

  5. Slide 5: Summary of Q2 Results

    Summary of Q2 Results ( Billion Yen / Rounded ) 2018Q2 2019Q2 2019Q4 Changes Progress Results Results Plan* [Cumulative] [Cumulative] [Cumulative] Revenue 134.3 151.4 +17.1 (+13%) 305.0 50% Gross Profit 97.4 112.8 +15.4 (+16%) 224.0 50% [Gross Profit margin] [72%] [74%] [73%] Core OP 28.4 32.2 +3.8

  6. Slide 6: YoY Analysis -Revenue-

    YoY Analysis ‐Revenue‐  Domestic Drug +2.9 • Positive: New product line including Rituximab BS (+3.0), +17.1 billion yen Orkedia (+2.7), G‐Lasta (+2.0), Dovobet (+0.6), Nouriast (+0.4) and Lumicef (+0.3) maintained steady growth. (incl. forex effect ‐1.4) • Negative: There are negative impacts by t

  7. Slide 7: Revenue of Major Items (Japan)

    Revenue of Major Items (Japan) ( Billion yen / Rounded ) 2018Q2 2019Q2 Changes Reason 2019Q4 Progress Item Results Results Plan*2 [Cumulative] [Cumulative] [Cumulative] Nesp+Authorized ver.*1 25.6 25.6 +0.1 (+0%) 48.4 53% A competitor’s penetration Regpara 7.8 3.8 ‐4.0 (‐51%) 5.1 74% & switch to Ork

  8. Slide 8: Revenue of Major Items (Overseas)

    Revenue of Major Items (Overseas) ( Billion yen / Rounded ) 2018Q2 2019Q2 Changes Reason 2019Q4 Progress Item Results Results Plan*4 [Cumulative] [Cumulative] [Cumulative] Crysvita*1 0.8 13.4 +12.5 (+1474%) Launched in Apr 2018 Undisclosed ― North America 9.9 Europe & other 3.5 Poteligeo ー 5.4 +5.4

  9. Slide 9: YoY Analysis -Core OP-

    YoY Analysis ‐Core OP‐ +3.8 billion yen  Gross Profit +15.4 (incl. forex effect ‐1.0) • Increased in conjunction with the rise in the revenue. (incl. forex effect ‐0.2) Gross profit margin up by 2 points, from 72% to 74%. (¥Bn)  SG&A ‐7.0 (incl. forex effect +0.7) • Increased selling and launch re

  10. Slide 10: YoY Analysis -Profit-

    YoY Analysis ‐Profit‐ Profit (Jan‐Jun) +13.8 billion yen (¥Bn) • Gain on sale of Kyowa Hakko Bio shares (post‐tax) +29.7 • Impact by deconsolidation of Biochemicals business ‐3.0 • Gain on sale of Kyowa Medex shares (2018) ‐11.0 • Gain on reversal of impairment losses (2018) ‐3.4 • Business restruct

  11. Slide 11: R&D Review

    R&D Review © Kyowa Kirin Co., Ltd. 11

  12. Slide 12: Key development updates in 19Q2

    Key development updates in 19Q2 • Application for approval of KHK4827 for the treatment of psoriasis in China (April) • Application for approval of KRN23 for the treatment of XLH in Korea1 (May) and China (June) • Completion of the patient enrollment in the phase 3 AYAME study of RTA 402 for the tre

  13. Slide 13: Business Topics

    Business Topics © Kyowa Kirin Co., Ltd. 13

  14. Slide 14: Business Topics

    Business Topics • Kyowa Kirin Frontier to sell Darbepoetin Alfa Injection Syringe [KKF] (August) • Kyowa Kirin buys back Tivozanib non‐oncology rights from Aveo Oncology (August) © Kyowa Kirin Co., Ltd. 14

  15. Slide 15: Appendix

    Appendix © Kyowa Kirin Co., Ltd. 15

  16. Slide 16: FOREX Information

    FOREX Information Average FOREX Rate ( Yen) 2018Q2 2019Q2 2019Q4 Currency Changes Results Results Plan USD/JPY 109 110 +1 110 GBP/JPY 151 143 ‐8 145 YoY FOREX Impact ( Billion yen ) Currency On Revenue On Core OP USD +0.1 +0.0 GBP ‐1.2 +0.0 © Kyowa Kirin Co., Ltd. 16

  17. Slide 17: Key progress in development (2019 H1)

    Key progress in development (2019 H1) Note: Listed events were completed between January 1st ,2019 and June 30th, 2019. Generic name Month Indication Country/region Event Code Burosumab Jan. XLH1 JP US EU RoW Filed KRN23 Tenapanor Hyperphosphatemia under Feb. JP US EU RoW Initiated phase 2 study KHK

  18. Slide 18: Submission plan of major pipeline

    Submission plan of major pipeline As of June 30th, 2019 Generic name Indication Country/region 2019 2020 2021~ Code Burosumab 1 KRN23 XLH (adult) JP US EU RoW Submission + Burosumab JP US EU RoW Filed + KRN23 XLH2 Burosumab KRN23 XLH JP US EU AS Filed3 + Evocalcet KHK7580 PHPT JP US EU RoW Filed + I

  19. Slide 19: Development plan of major pipeline

    Development plan of major pipeline As of June 30th, 2019 Generic name Indication Country/region 2019 2020 2021~ Code Bardoxolone methyl Diabetic Kidney disease RTA 402 JP US EU RoW Phase 3 Bleselumab1 Recurrence of FSGS in de ASKP1240 novo kidney transplant JP US EU RoW Phase 2 Entinostat KHK2375 Br

  20. Slide 20: Estimated annual incidence/prevalence

    Estimated annual incidence/prevalence Disease Country Estimated # of Incidence (i) Source /region or Prevalence (p) ATL Japan i: 1,150 per year i: Survey and countermeasures to HTLV‐1 infection and related diseases in Japan. 2009 summary p: 2,000 research report (Yamaguchi, 2010) p: Ministry of Heal

  21. Slide 21: Crysvita - Collaboration with Ultragenyx

    Crysvita ‐ Collaboration with Ultragenyx ‐ Kyowa Kirin Group Ultragenyx  Books sales  For first 5 years, splits profits in half U.S.A  For first 5 years, splits profits in half  After 5 years, receives mid to high 20% range sales /Canada  After 5 years, pays mid to high 20% range sales royalty

  22. Slide 22: List of acronyms

    List of acronyms AA Aplastic Anemia AD Atopic Dermatitis ATL Adult T‐Cell Leukemia/Lymphoma BS Biosimilar CKD Chronic Kidney Disease CTCL Cutaneous T‐Cell Lymphoma DKD Diabetic Kidney Disease ENS Epidermal Nevus Syndrome FSGS Focal Segmental Glomerulosclerosis HAM HTLV‐1 Associated Myelopathy HSC He

  23. Slide 23: Kyowa Kirin Co., Ltd. Corporate Communications Dept, IR Group

    Kyowa Kirin Co., Ltd. Corporate Communications Dept, IR Group +81-3-5205-7206 / ir@kyowakirin.com

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