Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — Q1 2018 Earnings Presentation
29 slides from Kyowa Kirin's earnings presentation, 2018
Slide 1: Result Presentation Fiscal 2018 First Quarter
Result Presentation Fiscal 2018 First Quarter Kyowa Hakko Kirin Co., Ltd. © Kyowa Hakko Kirin Co., Ltd.
Slide 2: Agenda
Agenda Results Summary & 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 Wataru Murata Executive Officer, Director of Corporate Strategy & Planning Department
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
Slide 4: Results Summary & Financial Review
Results Summary & Financial Review © Kyowa Hakko Kirin Co., Ltd. 4
Slide 5: Summary of Consolidated Results
Summary of Consolidated Results 2017Q1 2018Q1 Changes Results Results • Shrink in domestic drug and technology licensing Revenue 91.3 84.7 ‐6.6 revenue (↓) (‐7%) • Deconsolidation of Kyowa Medex (↓) Core Operating • Improvement of FKB’s 16.8 16.2 ‐0.5 Profit (Core OP) profit/loss (equity method) [Ma
Slide 6: Consolidated: YoY Analysis - Profit
Consolidated：YoY Analysis ‐Profit‐ Profit +10.0 billion yen Gain on sale & valuation of Kyowa (¥Bn) Medex shares +11.0 Gain on reversal of impairment losses +3.4 Upfront revenue from license‐out of FKB327 commercial right in EU Decrease in R&D expenses for FKB327 Pharmaceuticals ‐3.0 Pharmaceu
Slide 7: Summary of Results by Segment
Summary of Results by Segment Pharmaceuticals’ Core OP decreased due to the shrink in the domestic drug sales & tech‐licensing revenue Bio‐Chemicals’ Core OP fell due to aggressive advertisements for the future mail‐order business’ expansion 2017Q1 2018Q1 2018 Progression Changes Rate Results Re
Slide 8: Pharmaceuticals: YoY Analysis - Revenue
Pharmaceuticals: YoY Analysis ‐Revenue‐ ‐5.8 billion yen Domestic Drug ‐3.3 • NEGATIVE･･･Regpara dropped due to the competing (incl. forex effect +0.4) product. Long‐listed products including Allelock, Coniel, Asacol, and Depakene decreased due mainly to the penetration of generic drugs. • POSITIV
Slide 9: Pharmaceuticals: YoY Analysis - Core OP
Pharmaceuticals: YoY Analysis ‐Core OP‐ ‐0.7 billion yen (incl. forex effect ‐0.2) Gross Profit ‐3.0 (incl. forex effect +0.3) • Due to decrease in the sales revenue. (¥Bn) SG&A ‐1.4 (incl. forex effect ‐0.5) • Mainly due to boost in launch readiness expenses for Crysvita (burosumab). R&D +1.1
Slide 10: Pharmaceuticals: Revenue of Major Items
Pharmaceuticals: Revenue of Major Items 2017Q1 2018Q1 2018 Progression Item Results Results Changes Reason Plan Rate NESP 12.5 12.0 -0.5 Timing of shipment 52.4 23% JP (-4%) REGPARA 4.6 3.6 -1.0 Market penetration 13.2 27% JP (-22%) of the competitor Market penetration ALLELOCK 5.6 4.6 -1.0 of GE dr
Slide 11: Bio-Chemicals: YoY Analysis - Revenue
Bio‐Chemicals: YoY Analysis ‐Revenue‐ ‐1.0 billion yen (incl. forex effect +0.2) Overseas ‐0.1 (incl. forex effect +0.2) • Americas +0.0 (incl. forex effect ‐0.1) • Europe +0.2 (incl. forex effect +0.3) (¥Bn) • Asia & others ‐0.3 (incl. forex effect ‐0.0): Due to fiercer competition in China. Ph
Slide 12: Bio-Chemicals: YoY Analysis - Core OP
Bio‐Chemicals: YoY Analysis ‐Core OP‐ ‐0.3 billion yen (incl. forex effect +0.1) (¥Bn) Gross Profit ‐0.0 (incl. forex effect +0.0) • Maintained a same level as last year through the improvement of profitability. SG&A ‐0.3 (incl. forex effect +0.0) • Advertisement increased aiming for the mail or
Slide 13: R&D Review
R&D Review © Kyowa Hakko Kirin Co., Ltd. 13
Slide 14: Key development events in 2018
Key development events in 2018 Generic name Country/ Indication Month Event Code region Bardoxolone methyl Diabetic kidney Japan Mar. Designated under the SAKIGAKE system1 RTA 402 disease Approved Europe Jan. Benralizumab2 (BN: Fasenra) Asthma KHK4563 Approved Japan Jan. (BN: Fasenra subcutaneous in
Slide 15: Key development events in 2018 (after April)
Key development events in 2018 (after April) • Approval of burosumab‐twza (brand name1: Crysvita) for the treatment of pediatric and adult patients with XLH in the U.S. 1The brand name is used in the U.S. and Europe. Note: Listed events were completed between April 1, 2018 and May 8, 2018. © Kyowa H
Slide 16: Key development events in 2018 (after April, cont.)
Key development events in 2018 (after April, cont.) • Discontinued development for mogamulizumab in combination with PF‐05082566 for the treatment of solid tumors based on a collaboration agreement on immuno‐oncology combination therapies with Pfizer • Discontinued development for mogamulizumab in c
Slide 17: Business Topics
Business Topics © Kyowa Hakko Kirin Co., Ltd. 17
Slide 18: Progress in products under the alliances with partners
Progress in products under the alliances with partners Country/ Product Indication Month Event region Dovobet Gel Psoriasis Japan Feb. Approved CD20 positive, B‐cell non Hodgkin’s lymphoma CD20 positive, B‐cell Rituximab BS lymphoma under Intravenous immunosuppressed Japan Jan. Launched Infusi
Slide 19: Progress in the BS business: FKB327
Progress in the BS business (FUJIFILM KYOWA KIRIN BIOLOGICS) FKB327 (Biosimilar to Humira <adalimumab>) Submitted an application for marketing authorization to the European Medicines Agency in the EU, and it was accepted on May 18, 2017 Concluded an exclusive sales agreement with Mylan for Europ
Slide 20: Progress in the BS business: FKB238
Progress in the BS business (FUJIFILM KYOWA KIRIN BIOLOGICS) FKB238 (Biosimilar to Avastin <bevacizumab>) Concluded an agreement with AstraZeneca and established a joint venture (Centus Biotherapeutics) funded equally by both parties in 2015 The above joint venture is currently conducting a phas
Slide 21: Summary of the biosimilar business
Progress in the BS business (Fujifilm Kyowa Kirin Biologics) Summary of the biosimilar business at Fujifilm Kyowa Kirin Biologics Planning to start sales of FKB327 by Mylan in Europe from around 2019, and it is expected that capital recovery will begin before long Development of FKB238 by the jo
Slide 22: Appendix
Appendix © Kyowa Hakko Kirin Co., Ltd. 22
Slide 23: FOREX Information
FOREX Information Average FOREX Rate [ Yen ] 2017Q1 2018Q1 2018 Currency Changes Results Results Plan USD/JPY 115 110 ‐5 110 EUR/JPY 122 134 +12 130 GBP/JPY 143 152 +9 150 2018Q1 FOREX Effect (YoY) [ Million Yen] Segment Currency Revenue Core OP USD ‐190 ‐70 Pharmaceuticals EUR +20 +10 GBP +510 ‐130
Slide 24: Burosumab: Collaboration with Ultragenyx (summary)
Burosumab： Collaboration with Ultragenyx (summary) KHK group Ultragenyx Splits profits in half with KHK Books sales for first 5 years U.S.A Splits profits in half with Ultragenyx for first 5 years After 5 years, receives mid to Canada After 5 years, pays mid to high 20% range sales royalty
Slide 25: Development schedule of major pipeline
Development schedule of major pipeline As of March 31 +：Estimated time of regulatory decisions Generic name Country/ Indication 2018 2019 2020~ Code region Bardoxolone methyl Diabetic kidney Japan Phase 3 RTA 402 disease Benralizumab11 U.S., Europe Submission COPD KHK4563 Japan Submission Psoriasis
Slide 26: Development schedule of major pipeline (cont.)
Development schedule of major pipeline (cont.) As of March 31 Country/ Code Indication 2018 2019 2020~ region Recurrence of FSGS in ASKP1240 5 de novo kidney U.S. Phase 2 transplant Ulcerative colitis U.S., Europe Phase 2 KHK4083 U.S., Europe, Atopic dermatitis Phase 2 Japan KW‐6356 Parkinson’s dise
Slide 27: Biosimilar product development
Biosimilar product development Development Reference bio medical product Development stage Country/region code Generic name Brand name Phase 2 Phase 3 Application FKB327 Adalimumab HUMIRA U.S., others 1 FKB238 Bevacizumab Avastin U.S., Europe, others Not Not Not Not disclosed disclosed disclosed dis
Slide 28: List of acronyms
List of acronyms BS Biosimilar COPD Chronic Obstructive Pulmonary Disease CTCL Cutaneous T‐Cell Lymphoma FSGS Focal Segmental Glomerulosclerosis HTLV‐1 Human T‐cell Leukemia Virus Type 1 ITP Idiopathic (immune) Thrombocytopenic Purpura XLH X‐linked Hypophosphatemia © Kyowa Hakko Kirin Co., Ltd. 28
Slide 29: Kyowa Hakko Kirin Group mission and IR contact
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