Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — Q2 2021 Earnings Presentation

27 slides from Kyowa Kirin's earnings presentation, August 2021

  1. Slide 1: Results Presentation Fiscal 2021 Second Quarter

    Results Presentation Fiscal 2021 Second Quarter

  2. Slide 2: Agenda

    Agenda Financial Review Commercial Update R&D Update President and CEO Masashi Miyamoto, Ph.D. Q&A President and CEO Masashi Miyamoto, Ph.D. Executive Officer, Head of Finance Motohiko Kawaguchi Executive Officer, Vice President, Head of R&D Yoshifumi Torii, Ph.D. Executive Officer, Head of Global P

  3. Slide 3: Forward-looking statements

    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: Financial Review

    Financial Review © Kyowa Kirin Co., Ltd. 4

  5. Slide 5: Summary of Q2 Results

    Summary of Q2 Results ( Billion Yen / Rounded ) 2020Q2 2021Q2 Changes 2021 Progresses Results Results Plans Revenue 157.8 165.0 +7.2 (+5%) 351.0 47% [Overseas Ratio] [46%] [52%] [54%] Gross Profit 116.9 123.8 +6.9 (+6%) 270.0 46% [Gross Profit Margin] [74%] [75%] [77%] SG&A 58.2 67.2 +9.0 (+15%) 141

  6. Slide 6: YoY Analysis -Revenue-

    YoY Analysis ‐Revenue‐  Japan ‐5.4 Crysvita, Haruropi, Duvroq (New products), G‐Lasta (Market’s expansion & recovery) and +7.2 billion yen Patanol (Higher pollen) and increased. However, Nesp‐AG (Competitors) and Romiplate (Supply constraints) were down. In addition, there were negative impacts by

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

    Revenue of Major Items (Japan) ( Billion Yen / Rounded ) 2020Q2 2021Q2 Changes 2021 Progresses Item Results Results Reasons Plans Nesp + Nesp‐AG*1 14.6 12.9 ‐1.7 (‐11%) 23.2 56% Biosimilars’ penetration Nesp 2.2 1.9 ‐0.3 (‐14%) & NHI price‐cut 3.8 50% Nesp‐AG 12.4 11.0 ‐1.4 (‐11%) 19.4 57% Duvroq ー

  8. Slide 8: Revenue of Major Items (ex-Japan)

    Revenue of Major Items (ex‐Japan) ( Billion Yen / Rounded ) 2020Q2 2021Q2 Changes 2021 Progresses Item Reasons Results Results Plans Crysvita 24.7 35.4 +10.7 (+43%) [North America] Market penetration 77.2 46% & Expanded indication (TIO) North America 19.2 25.7 +6.5 (+34%) [EMEA] Farther launches & E

  9. Slide 9: YoY Analysis -Core OP-

    YoY Analysis ‐Core OP‐ ‐3.5 billion yen (incl. forex effect +0.2)  Gross Profit +6.9 (incl. forex effect +1.1) • Increased in conjunction with 7.2B yen rise in revenue. Gross profit margin made 1 point improvement from 74% to 75%.  SG&A ‐9.0 (incl. forex effect ‐0.9) Increased for the maximization

  10. Slide 10: YoY Analysis -Profit-

    YoY Analysis ‐Profit‐ Profit (Jan‐Jun) ‐2.7 billion yen • UK subsidiary boosted differed tax assets in Q1 2020 • Impairment Losses (2.7→0.7) +2.0 • Business restructuring expenses (2.1→0.1) +2.0 Core Operating Profit ‐3.5 Profit Before Tax +0.2 © Kyowa Kirin Co., Ltd. 10

  11. Slide 11: Commercial Update

    Commercial Update © Kyowa Kirin Co., Ltd. 11

  12. Slide 12: Crysvita Topics and Launched Countries

    （Billion Yen） 25 Topics  North America: Steady progress in the number of newly treated 20 1.9 patients.  EMEA: (EU) Self‐injection approved. (Germany) Expansion of 1.4 1.5 indication for adult use contributed.  AP: (China) Preparation for launch on track. (Singapore) XLH 15 1.1 approval. 0.8 14.0

  13. Slide 13: Product Topics and Launched Countries

    （Billion Yen） 5 Topics 4 0.5  Therapeutic effect in cases with hematological tumor.  North America: Sales improved (Signs of recovery). 0.5 3 0.5 0.6  EMEA: Reimbursement negotiations are delaying due to Cov19. 0.5 Japan  Asia: (China) Filed for regulatory approval in June. 3.2 2 2.6 North Ameri

  14. Slide 14: Business Topics

    Business Topics © Kyowa Kirin Co., Ltd. 14

  15. Slide 15: Agreement with Amgen for KHK4083 in atopic dermatitis

    Signed an agreement with Amgen for joint development and commercialization of KHK4083, a potent treatment for atopic dermatitis (Disclosed on June 1) • On June 1, Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize KHK4083, an anti‐OX40 fully human monoclonal antibod

  16. Slide 16: R&D Update

    R&D Update © Kyowa Kirin Co., Ltd. 16

  17. Slide 17: Upcoming Events: Next-generation Strategic Products

    Upcoming Events: Next‐generation Strategic Products : Completed events from Jan 1 to May 6, 2021 : Completed events from May 7 to Aug 3, 2021 Code Target disease H1 2021 H2 2021 H1 2022 generic name KHK4083 Atopic dermatitis P2b topline data P2b detailed data P3 FPI P2b detailed data KW‐6356 Parkins

  18. Slide 18: Zandelisib: Phase 1b Study in B-cell Malignancies

    Zandelisib: Results of a Phase 1b Study in B‐cell Malignancies Efficacy and Safety in patients with R/R FL with POD24 ASCO 2021 ClinicalTrials.gov Identifier: NCT02914938  Treatment: Zandelisib monotherapy or in combination with rituximab administered in IS Daily No therapy Daily dosing x2 cycles x

  19. Slide 19: Zandelisib in combination with Zanubrutinib

    Zandelisib: Results of a Phase 1b Study in B‐cell Malignancies ASCO 2021 Zandelisib in combination with Zanubrutinib ClinicalTrials.gov Identifier: NCT02914938 Treatment schedule Group Zandelisib, 60mg Zanubrutinib Daily dosing x2 cycles Daily No therapy Group A x1 week x3 weeks 160 mg, oral, bid (n

  20. Slide 20: Expanding Zandelisib Development Activities

    Expanding Zandelisib Development Activities to Explore Full Potential 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+ ‧ Ph 2 Study K02 in ‧ + R‐CHOP in DLBCL

  21. Slide 21: Appendix

    Appendix © Kyowa Kirin Co., Ltd. 21

  22. Slide 22: FOREX Information

    FOREX Information Average FOREX Rate (Yen) Currency 2020Q2 2021Q2 Change 2021 Results Results Plans USD/JPY 109 107 ‐2 105 GBP/JPY 138 147 +9 140 2021Q2 FOREX Impacts (YoY) (Billion yen) Currency Revenue Core OP USD/JPY ‐1.0 ‐0.5 GBP/JPY +1.7 +0.3 FY2021 FOREX Sensitivity (Billion yen) Currency Chan

  23. Slide 23: Crysvita - Collaboration with Ultragenyx

    Crysvita ‐ Collaboration with Ultragenyx ‐ Territories Economic terms • Kyowa Kirin books sales • 50/50 profit share for 5 years from the U.S. launch U.S. & Canada • After 5 years, Kyowa Kirin pays tiered sales royalties in mid‐high 20% range to Ultragenyx • Supply price: 35% of net sales through 20

  24. Slide 24: Development Plan of Next-generation Strategic Products

    Development Plan of Next‐generation Strategic Products T : Topline data D : Detailed data As of Aug 3rd, 2021 Code ＋ generic name Target disease 2021 2022 2023 P2b T D KHK4083 Atopic dermatitis P3 P2b D KW‐6356 Parkinson’s disease P3 FL (mono, 3L) P2 T ME‐401 MZL (mono, 3L) P2 Zandelisib FL/MZL (com

  25. Slide 25: Estimated Patient Numbers

    Estimated Patient Numbers Country/ Disease Incidence Prevalence* Reference Region ATL JP 1,150 / y Survey and countermeasures to HTLV‐1 infection and related diseases in Japan. 2009 summary research report (Yamaguchi, 2010) PTCL JP 2,000 Ministry of Health, Labour and Welfare: 2017 Patient survey (i

  26. Slide 26: List of Acronyms

    List of Acronyms AD Atopic Dermatitis AG Authorized Generic ATL Adult T‐Cell Leukemia/Lymphoma BS Biosimilar CKD Chronic Kidney Disease CLL Chronic Lymphocytic Leukemia DKD Diabetic Kidney Disease DLBCL Diffuse Large B‐Cell Lymphoma FL Follicular Lymphoma iNHL Indolent B‐cell Non‐Hodgkin Lymphoma MC

  27. Slide 27: Kyowa Kirin Co., Ltd. IR Group

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

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