Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — Kyowa Hakko Kirin — Q1 2019 Earnings Presentation

26 slides from Kyowa Kirin's earnings presentation, 2019

  1. Slide 1: Results Presentation Fiscal 2019 First Quarter

    Results Presentation Fiscal 2019 First Quarter Kyowa Hakko Kirin Co., Ltd. © Kyowa Hakko Kirin Co., Ltd.

  2. Slide 2: Agenda

    Agenda Financial Review Motohiko Kawaguchi Executive Officer, Director of Accounting Department R&D Review Mitsuo Satoh, Ph.D Executive Officer, Vice President, Head of R&D Division Business Topics Takeyoshi Yamashita, Ph.D Executive Officer, Director of Corporate Strategy & Planning Department Q&A

  3. Slide 3: Forward-looking statements

    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 pr

  4. Slide 4: Financial Review

    Financial Review © Kyowa Hakko Kirin Co., Ltd. 4

  5. Slide 5: Summary of the Consolidated Results

    Summary of the Consolidated Results ( Billion Yen / Rounded ) 2018Q1 2019Q1 2019Q4 Results Results Changes Plan Progress (5‐Feb‐2019) Revenue 66.5 75.8 +9.3 (+14%) 305.0 25% Gross Profit 46.7 56.1 +9.4 (+20%) 224.0 25% [Gross Profit margin] [70%] [74%] [73%] Core OP 14.4 17.3 +2.9 (+20%) 53.0 33% [C

  6. Slide 6: YoY Analysis - Revenue

    YoY Analysis ‐Revenue‐ +9.3 billion yen  Domestic Drug +2.5 • Positive: New product line including Rituximab‐BS (+1.5), (incl. forex effect ‐0.9) Orkedia (+1.2), G‐Lasta (+0.9), Dovobet (+0.4), Nouriast (+0.3) and Lumicef (+0.2) maintained steady growth. Patanol also increased due to the higher amo

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

    Revenue of Major Items (Japan) ( Billion yen / Rounded ) 2018Q1 2019Q1 Changes Reason 2019Q4 Progress Item Results Results Plan Nesp+AG* 12.0 11.8 ‐0.2 (‐2%) 48.4 24% A competitor’s market Regpara 3.6 1.8 ‐1.7 (‐48%) 5.1 36% penetration & shift to Orkedia Orkedia ― 1.2 +1.2 Launched on May 2018 9.5

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

    Revenue of Major Items (Overseas) ( Billion yen / Rounded ) 2018Q1 2019Q1 Changes Reason 2019Q4 Progress Item Results Results Plan Crysvita* ― 5.7 +5.7 Launched on Apr 2018 Undisclosed ― Poteligeo ― 2.4 +2.4 Launched on Oct 2018 10.0 24% Abstral 3.4 3.1 ‐0.3 (‐9%) 12.3 25% Technology 6.5 3.2 ‐3.3 (‐

  9. Slide 9: YoY Analysis - Core OP

    YoY Analysis ‐Core OP‐ +2.9 billion yen  Gross Profit +9.4 (incl. forex effect ‐0.5) (incl. forex effect +0.1) • Increased in conjunction with the rise in the revenue. Gross profit margin up by 4 points, from 70% to 74%. (¥Bn)  SG&A ‐3.2 (incl. forex effect +0,6) • Increased selling and launch rea

  10. Slide 10: YoY Analysis - Profit

    YoY Analysis ‐Profit‐ Profit (Jan‐Mar) ‐13.9 billion yen (¥Bn) • Gain on Sale of Kyowa Medex shares (2018) ‐11.0 • Gain on Reversal of impairment losses (2018) ‐3.4 • Business restructuring expenses (2019) ‐5.1 • Business improving expenses (post‐tax) ‐1.3 • Tax effects related to the decision to sa

  11. Slide 11: R&D Review

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

  12. Slide 12: Key development updates in 19Q1

    Key development updates in 19Q1 • Application for approval of KRN23 for the treatment of FGF23‐related hypophosphatemic rickets and osteomalacia in Japan • Initiation of the phase 2 clinical study of KHK7791 for the treatment of hyperphosphatemia under maintenance dialysis in Japan © Kyowa Hakko Kir

  13. Slide 13: KHK7791: Phase 3 Study Results (conducted by Ardelyx in the US)

    KHK7791: Phase 3 Study Results (conducted by Ardelyx in the US) J Am Soc Nephrol. 2019 Apr;30(4):641‐652. • Study design • Efficacy result Change in serum phosphate levels Serum phosphate levels during randomized withdrawal period © Kyowa Hakko Kirin Co., Ltd. 13

  14. Slide 14: KHK7791: Phase 2 Study Design

    KHK7791: Phase 2 Study Design ClinicalTrials.gov Identifier: Dose‐finding Study of KHK7791 in Hyperphosphatemia Patients NCT03864458  Study design KHK7791; Arm A Randomization KHK7791; Arm B Screening KHK7791; Arm C KHK7791; Arm D N=200 (1:1:1:1:1) Placebo Up to 3‐week 6‐week treatment period 3‐wee

  15. Slide 15: Key development events in 2019 (after April)

    Key development events in 2019 (after April) • Resubmission of application for approval of istradefylline for the treatment of Parkinson’s disease in the U.S. Note: Listed event was completed between April 1, 2019 and May 7, 2019. © Kyowa Hakko Kirin Co., Ltd. 15

  16. Slide 16: Business Topics

    Business Topics © Kyowa Hakko Kirin Co., Ltd. 16

  17. Slide 17: Maximizing the value of Benralizumab

    Maximizing the value of Benralizumab Agreed to grant AstraZeneca exclusive development and commercialization rights for all indications, including the already agreed to rights for asthma and COPD, in Asia, including Japan  With this new agreement, AstraZeneca now possesses global rights to all of t

  18. Slide 18: Appendix

    Appendix © Kyowa Hakko Kirin Co., Ltd. 18

  19. Slide 19: FOREX Information

    FOREX Information Average FOREX Rate [ Yen ] 2018Q1 2019Q1 2019Q4 Currency Changes Results Results Plan USD/JPY 110 110 ― 110 GBP/JPY 152 143 ‐9 145 FOREX Effect (YoY) [ Billion Yen] Segment Currency Revenue Core OP USD ― ― Pharmaceuticals GBP ‐0.7 +0.3 © Kyowa Hakko Kirin Co., Ltd. 19

  20. Slide 20: Key progress in development (2019 Q1)

    Key progress in development (2019 Q1) Note: Listed events were completed between January 1st ,2019 and March 31st, 2019. Generic name Month Indication Country/region Event Code Burosumab Jan. KRN23 XLH1 JP US EU etc Filed Tenapanor Hyperphosphatemia under Feb. KHK7791 maintenance dialysis JP US EU e

  21. Slide 21: Key progress in development (after April)

    Key progress in development (after April) Note: Listed events were completed between April 1st, 2019 and May 7th, 2019. Generic name Month Indication Country/region Event Code Istradefylline Apr. KW‐6002 Parkinson’s disease JP US EU etc Accepted resubmission Hypercalcemia In patients with Evocalcet

  22. Slide 22: Submission plan of major pipeline

    Submission plan of major pipeline As of March 31st, 2019 Generic name Indication Country/region 2019 2020 2021~ Code Burosumab KRN23 XLH (adult)1 JP US EU etc Submission + Burosumab KRN23 XLH2 JP US EU etc Filed + Burosumab KRN23 XLH JP US EU KR Submission + Evocalcet KHK7580 PHPT JP US EU etc Submi

  23. Slide 23: Development plan of major pipeline

    Development plan of major pipeline As of March 31st, 2019 Generic name Indication Country/region 2019 2020 2021~ Code Bardoxolone methyl RTA 402 Diabetic kidney disease JP US EU etc Phase 3 Bleselumab Recurrence of FSGS in de ASKP1240 novo kidney transplant1 JP US EU etc Phase 2 Entinostat KHK2375 B

  24. Slide 24: Burosumab: Collaboration with Ultragenyx (summary)

    Burosumab： Collaboration with Ultragenyx (summary) KHK group Ultragenyx Splits profits in half with Books sales KHK for first 5 years U.S.A Splits profits in half with Ultragenyx for first 5 years After 5 years, receives mid Canada After 5 years, pays mid to high 20% range sales to high 20% ran

  25. Slide 25: List of acronyms

    List of acronyms BS Biosimilar COPD Chronic Obstructive Pulmonary Disease FSGS Focal Segmental Glomerulosclerosis HAM HTLV‐1 Associated Myelopathy ITP Idiopathic (immune) Thrombocytopenic Purpura PHPT Primary Hyperparathyroidism SHPT Secondary Hyperparathyroidism XLH X‐linked Hypophosphatemia © Kyow

  26. Slide 26: Kyowa Hakko Kirin Group contact information

    The Kyowa Hakko Kirin Group companies strive to contribute to the health and well‐being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. Kyowa Hakko Kirin Co Ltd Corporate Communications Dept, IR Group Tel: +81‐3‐5205‐7206 © Kyowa Ha

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