Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q3 2020 Earnings Presentation
26 slides from Kyowa Kirin's earnings presentation, 2020
Slide 1: Results Presentation Fiscal 2020 Third Quarter
Results Presentation Fiscal 2020 Third Quarter
Slide 2: Agenda
Agenda Financial Review Motohiko Kawaguchi Executive Officer, Director of Finance Dept R&D Review Yoshifumi Torii, Ph.D Executive Officer, Vice President, Head of R&D Div Business Topics Takeyoshi Yamashita, Ph.D Executive Officer, Director of Corporate Strategy & Planning Dept Q&A © Kyowa Kirin Co.
Slide 3: Forward-looking statements notice
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
Slide 4: Financial Review
Financial Review © Kyowa Kirin Co., Ltd. 4
Slide 5: Summary of Q3 Results
Summary of Q3 Results ( Billion Yen / Rounded ) 2019Q3 2020Q3 2020 Changes Progress Results Results New Plan Revenue 225.5 234.0 +8.5 (+4%) 313.0 75% [Overseas Ratio] [39%] [47%] [47%] Gross Profit 168.4 175.4 +7.0 (+4%) 236.0 74% [Gross Profit margin] [75%] [75%] [75%] Core OP 45.8 50.7 +4.9 (+11%)
Slide 6: YoY Analysis -Revenue-
YoY Analysis ‐Revenue‐ Japan ‐12.5 • In addition to newly‐launched Crysvita, Romiplate (Additional indication), Rituximab BS and G‐Lasta made strong growth. +8.5 billion yen However, they could not cover the impact such as the shrink of Nesp (Shift to Nesp‐AG) and Patanol/Allelock (Lower pollen (i
Slide 7: Revenue of Major Items (Japan)
Revenue of Major Items (Japan) ( Billion yen / Rounded ) 2019Q3 2020Q3 Changes Reason 2020 Progress Item Results Results New Plan Nesp + Nesp‐AG* 37.6 21.9 ‐15.6 (‐42%) 28.9 76% Nesp‐AG launched in Aug 2019 Nesp 32.0 3.3 ‐28.7 (‐90%) and Biosimilars’ penetration 4.6 72% Nesp‐AG 5.6 18.6 +13.0 (+232%
Slide 8: Revenue of Major Items (Overseas)
Revenue of Major Items (Overseas) ( Billion yen / Rounded ) 2019Q3 2020Q3 Changes Reason 2020 Progress Item Results Results New Plan Crysvita*1 21.6 38.5 +16.9 (+79%) Steady market penetration 51.1 75% North America 16.3 30.3 +14.0 (+86%) EMEA 5.3 8.3 +3.0 (+56%) Launched in Jun 2020 and Poteligeo*2
Slide 9: YoY Analysis -Core OP-
YoY Analysis ‐Core OP‐ +4.9 billion yen Gross Profit +7.0 (incl. forex effect ‐1.7) (incl. forex effect ‐0.9) • Increased in conjunction with the rise in revenue. (¥Bn) SG&A ‐4.3 (incl. forex effect +0.7) • Increased selling and launch readiness expenses in the EU/US, including Crysvita’s profit
Slide 10: YoY Analysis -Profit-
YoY Analysis ‐Profit‐ Profit (Jan‐Sep) ‐18.8 billion yen (¥Bn) • KHB shares sold in Apr 2019 (Gain on sale of KHB shares 29.7) • Impairment losses (6.1→2.7) +3.4 • Business restructuring expenses (5.1→2.1) +3.0 • Foreign exchange gain/loss +1.3 • Provision for compensation loss ‐3.4 Core Operating P
Slide 11: R&D Review
R&D Review © Kyowa Kirin Co., Ltd. 11
Slide 12: Key Development Updates in 20Q3
Key Development Updates in 20Q3 • Approval of KRN23 for the treatment of FGF23‐related hypophosphatemic rickets and osteomalacia in Korea (September) • Approval of KRN23 for the treatment of adult XLH in Europe (September) • Discontinuation of the development of KW‐0761 for the treatment of adult T‐
Slide 13: Key Development Updates after September
Key Development Updates after September • Initiation of the pivotal phase 2 study of ME‐401 for the treatment of indolent B‐cell non‐Hodgkin’s lymphoma in Japan (October) • Announcement of the positive phase 2b results for KW‐6356 in patients with Parkinson’s disease in Japan (October) • Presentatio
Slide 14: Business Topics
Business Topics © Kyowa Kirin Co., Ltd. 14
Slide 15: Key Business Topics in 20Q3
Key Business Topics in 20Q3 • Launch of Duvroq for Patients with Renal Anemia due to Chronic Kidney Disease (August) • Centus Biotherapeutics* received European Marketing Authorization for Equidancent, biosimilar Avastin (September) • Provision for the payment responding to the compensation request
Slide 16: Launch of Duvroq for Patients with Renal Anemia due to CKD
Launch of Duvroq for Patients with Renal Anemia due to Chronic Kidney Disease (August) • Launched Duvroq, an oral HIF‐PH* inhibitor for the treatment of renal anemia due to chronic kidney disease (CKD), as the second group in the class for patients on dialysis, and as the first group in the class th
Slide 17: Product Portfolio in Nephrology Area
Product Portfolio in Nephrology Area *Under development Diabetic Kidney Disease Hyperphosphatemia RTA 402 * KHK7791 * Hypertension・ Diabetes CKD‐MBD Coniel・Coversyl・Onglyza Regpara・Orkedia・Rocaltrol・Phosblock Renal Anemia︓Espo・Nesp・Darbepoetin Alfa 「KKF」・Duvroq eGFR chronic kidney disease patients o
Slide 18: Appendix
Appendix © Kyowa Kirin Co., Ltd. 18
Slide 19: FOREX Information
FOREX Information Average FOREX Rate (Yen) 2019Q3 2020Q3 2020 Currency Changes Results Results New Plan USD/JPY 109 108 ‐1 108 GBP/JPY 140 137 ‐3 135 2020Q3 FOREX Impact (Billion yen) Currency Revenue Core OP USD/JPY ‐0.4 ‐0.2 GBP/JPY ‐1.0 ‐0.3 FY2020 Currency Fluctuation Sensitivity (New Plan) (Bil
Slide 20: Key progress in development (2020 Q3)
Key progress in development (2020 Q3) Note: Listed events were completed between January 1st, 2020 and September 30th, 2020. Generic name Month Code Indication Country/region Event Istradefylline Jan. KW‐6002 Parkinson’s disease EU Accepted MAA Pegfilgrastim Feb. KRN125 Chemotherapy induced febrile
Slide 21: Submission plan of major pipeline
Submission plan of major pipeline As of September 30th, 2020 Generic name Code Indication Country/region 2020 H1 2020 H2 2021 Brodalumab KHK4827 Psoriasis CN + Brodalumab KHK4827 Psoriasis AS +5 Brodalumab KHK4827 Axial spondyloarthritis JP + Brodalumab Psoriatic arthritis KHK4827 TW Filed + Burosum
Slide 22: Development plan of major pipeline
Development plan of major pipeline As of September 30th, 2020 Generic name Code Indication Country/region 2020 2021 2022~ Bardoxolone methyl Diabetic Kidney disease RTA 402 JP Phase 3 Bleselumab1 Recurrence of FSGS in ASKP1240 de novo kidney transplant US Phase 2 Phase 3 Entinostat Breast cancer KHK
Slide 23: 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 research report (Yamaguchi, 2010); p: p: 2,000 Ministry of Hea
Slide 24: 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
Slide 25: List of acronyms
List of acronyms AA Aplastic Anemia AD Atopic Dermatitis AG Authorized Generic ATL Adult T‐Cell Leukemia/Lymphoma BS Biosimilar CKD Chronic Kidney Disease CKD‐MBD Chronic Kidney Disease‐Mineral and Bone Disorder DKD Diabetic Kidney Disease ENS Epidermal Nevus Syndrome FL Follicular Lymphoma FSGS Foc
Slide 26: Kyowa Kirin Co., Ltd. IR contact
Kyowa Kirin Co., Ltd. Corporate Communications Dept., IR Group +81-3-5205-7206 / ir@kyowakirin.com