Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q3 2019 Earnings Presentation
22 slides from Kyowa Kirin's earnings presentation, 2019
Slide 1: Results Presentation Fiscal 2019 Third Quarter
Results Presentation Fiscal 2019 Third Quarter
Slide 2: Agenda
Agenda Financial Review Executive Officer, Head of Finance Dept Motohiko Kawaguchi R&D Review Executive Officer, Head of R&D Division Mitsuo Satoh, Ph.D Q&A © Kyowa Kirin Co., Ltd. 2
Slide 3: Forward-looking statements disclaimer
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 ) 2018Q3 2019Q3 2019Q4 Changes Progress Results Results Plan* [Cumulative] [Cumulative] [Cumulative] Revenue 197.7 225.5 +27.7 (+14%) 305.0 74% [Overseas Ratio] [32%] [38%] [39%] Gross Profit 143.8 168.4 +24.6 (+17%) 224.0 75% [Gross Profit margin] [73%]
Slide 6: YoY Analysis -Revenue-
YoY Analysis -Revenue- Domestic Drug +2.8 • Positive: Rituximab BS (+4.3), Orkedia (+3.7), G-Lasta (+3.5), Dovobet (+0.8), Romiplate(+0.6), Nouriast (+0.5) and Lumicef +27.7 billion yen (+0.5) maintained steady growth. • Negative: There were negative impacts by the drug price (incl. forex effect -
Slide 7: Revenue of Major Items (Japan)
Revenue of Major Items (Japan) ( Billion yen / Rounded ) 2018Q3 2019Q3 Changes Reason 2019Q4 Progress Item Results Results Plan [Cumulative] [Cumulative] [Cumulative] Nesp+Authorized ver. 39.2 37.6 -1.6 (-4%) 48.4 78% Switch to the authorized ver. Nesp 39.2 32.0 -7.2 (-18%) launched in Aug 2019 Auth
Slide 8: Revenue of Major Items (Overseas)
Revenue of Major Items (Overseas) ( Billion yen / Rounded ) 2018Q3 2019Q3 Changes Reason 2019Q4 Progress Item Results Results Plan [Cumulative] [Cumulative] [Cumulative] Crysvita*1 3.2 21.6 +18.4 (+572%) Launched in Apr 2018 Undisclosed ― North America 16.3 Europe & others 5.3 Poteligeo ー 8.0 +8.0 L
Slide 9: YoY Analysis -Core OP-
YoY Analysis -Core OP- +6.2 billion yen Gross Profit +24.6 (incl. forex effect -2.6) • Increased in conjunction with the rise in the revenue. (incl. forex effect -0.7) Gross profit margin up by 2 points, from 73% to 75%. (¥Bn) SG&A -11.6 (incl. forex effect +1.6) • Increased selling and launch r
Slide 10: YoY Analysis -Profit-
YoY Analysis -Profit- Profit (Jan-Sep) +8.9 billion yen • Gain on sale of Kyowa Medex shares (2018) -11.0 • Gain on reversal of impairment losses (2018) -3.4 • Gain on sale of fixed assets (2018) -3.7 (¥Bn) • Business restructuring expenses (2019) -5.1 • Impairment losses (2018･2019) -5.9 • Gain on
Slide 11: R&D Review
R&D Review © Kyowa Kirin Co., Ltd. 11
Slide 12: Key development updates in 19Q3
Key development updates in 19Q3 • Initiation of the phase 3 clinical study of KHK4827 for the treatment of palmoplantar pustulosis in Japan (August) • Approval of KW-6002 for the treatment of Parkinson’s disease in the U.S. (August) → The marketing strategy to be elaborated at the investor event on
Slide 13: Key development updates after September
Key development updates after September • Results of the phase 2 study of KHK4083 for the treatment of ulcerative colitis in the US and European countries: There was no significant difference in efficacy endpoints © Kyowa Kirin Co., Ltd. 13
Slide 14: Appendix
Appendix © Kyowa Kirin Co., Ltd. 14
Slide 15: FOREX Information
FOREX Information Average FOREX Rate (Yen) 2018Q3 2019Q3 2019Q4 Currency Changes Results Results Plan USD/JPY 109 109 ― 110 GBP/JPY 149 140 -9 145 YoY FOREX Impact (Billion yen) Currency On Revenue On Core OP USD -0.2 -0.2 GBP -2.1 +0.0 © Kyowa Kirin Co., Ltd. 15
Slide 16: Key progress in development (2019 Q1-Q3)
Key progress in development (2019 Q1-Q3) Note: Listed events were completed between January 1st ,2019 and September 30th, 2019. Generic name Month Indication Country/region Event Code Burosumab FGF23-related hypophosphatemic Jan. JP US EU RoW Filed KRN23 rickets and osteomalacia Tenapanor Hyperphosp
Slide 17: Submission plan of major pipeline
Submission plan of major pipeline As of September 30th, 2019 Generic name Indication Country/region 2019 2020 2021~ Code Burosumab 1 KRN23 XLH (adult) JP US EU RoW Submission + Burosumab KRN23 XLH2 JP US EU RoW Filed + Burosumab KRN23 XLH2 JP US EU AS Filed3 + Evocalcet KHK7580 PHPT JP US EU RoW Fil
Slide 18: Development plan of major pipeline
Development plan of major pipeline As of September 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 KHK23
Slide 19: 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
Slide 20: 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 21: 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
Slide 22: 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