Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — Q3 2018 Earnings Presentation
32 slides from Kyowa Kirin's earnings presentation, October 2018
Slide 1: Results Presentation Fiscal 2018 Third Quarter
Results Presentation Fiscal 2018 Third 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 Departmen
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 the Consolidated Results
Summary of the Consolidated Results 2017Q3 2018Q3 2018Q4 Progression Results Results Changes Plan Rate (30-Oct-2018) 335.0→ Revenue 261.3 253.9 ‐7.3 335.0 76% (‐3%) 51.0→ Core OP 44.7 45.9 +1.3 54.0 85% [Margin] [17.1%] [18.1%] (+3%) [16.1%] OP: Operating Profit 44.0→ Profit 29.5 47.4 +18.0 52.0 91%
Slide 6: Revision to Full-Year Forecast
Revision to Full‐Year Forecast 2018Q4 2018Q4 Changes Original Plan Revised Plan (8-Feb-2018) (30-Oct-2018) Revenue 335.0 335.0 ー Gain/loss on the equity method +3.0 Core OP 51.0 54.0 +3.0 Gain on reversal of impairment losses +3.4 Gain on sales of fixed Profit assets +3.7 61.0 71.0 +10.0 Before Tax
Slide 7: Consolidated: YoY Analysis - Profit
Consolidated: YoY Analysis ‐Profit‐ Profit (Jan‐Sep) +18.0 billion yen (¥Bn) Gain on sale & valuation of Kyowa Medex shares +11.0 Gain on reversal of impairment losses +3.3 Gain on sales of fixed assets +3.0 Pharmaceuticals ‐0.4 Pharmaceuticals ‐2.7 Bio‐Chemicals +1.2 Bio‐Chemicals ‐0.
Slide 8: Summary of the Results by Segment
Summary of the Results by Segment Pharmaceuticals’ Core OP slightly increased due to an improvement in the gain/loss on the equity method despite the lower revenue & higher expenses. Bio‐Chemicals’ Core OP increased due to improved profitability despite the lower revenue. 2017Q3 2018Q3 Changes 2
Slide 9: Pharmaceuticals: YoY Analysis - Revenue
Pharmaceuticals: YoY Analysis ‐Revenue‐ Domestic Drug ‐5.4 ‐5.3 billion yen • Positive: Rituximab‐BS which was launched in Jan (+2.4), Orkedia which was released in May (+1.1), and the other (incl. forex effect +1.3) new products such as G‐Lasta (+2.0), Lumicef (+0.9), Nouriast (+0.7) maintained s
Slide 10: Pharmaceuticals: YoY Analysis - Core OP
Pharmaceuticals: YoY Analysis ‐Core OP‐ +0.3 billion yen Gross Profit ‐0.4 (incl. forex effect +1.1) • Remained at the same level as the last year (incl. forex effect ‐0.1) as the increased overseas drug segment covered the lower domestic drug segment and the impact of (¥Bn) the deconsolidation of
Slide 11: Pharmaceuticals: Revenue of Major Items
Pharmaceuticals: Revenue of Major Items 2017Q3 2018Q3 Changes Reason 2018Q4 Progression Item Results Results Plan* Rate ‐1.8 Nesp JP 41.0 39.2 (‐4%) Drug price cut 52.4 75% ‐3.2 Market penetration Regpara JP 13.9 10.7 (‐23%) of a competitor & shift to Orkedia 13.2 81% Market penetration ‐2.4 of gene
Slide 12: Bio-Chemicals: YoY Analysis - Revenue
Bio‐Chemicals: YoY Analysis ‐Revenue‐ ‐2.3 billion yen (incl. forex effect +0.4) Overseas ‐1.0 (incl. forex effect +0.4) • Americas ‐0.3 (incl. forex effect ‐0.2) • Europe ‐0.1 (incl. forex effect +0.6): (¥Bn) Due to fiercer competition in certain products. • Asia & others ‐0.6 (incl. forex effect
Slide 13: Bio-Chemicals: YoY Analysis - Core OP
Bio‐Chemicals: YoY Analysis ‐Core OP‐ +0.8 billion yen (incl. forex effect +0.1) (¥Bn) Gross Profit +1.2 (incl. forex effect +0.1) • Manufacturing costs decreased by an increase in the overseas production. SG&A ‐0.5 (incl. forex effect ‐0.0) • Increased advertisements aimed at expanding the mail
Slide 14: R&D Review
R&D Review © Kyowa Hakko Kirin Co., Ltd. 14
Slide 15: Key development events in 2018 (1)
Key development events in 2018 (1) Generic name Country/ Indication Month Event Code region Bardoxolone methyl Diabetic kidney Mar. Designated under the SAKIGAKE system1 Japan RTA 402 disease May Initiated phase 3 study Europe Jan. Approved (BN: Fasenra) Benralizumab2 Asthma KHK4563 Approved (BN: Fa
Slide 16: Key development events in 2018 (2)
Key development events in 2018 (2) Generic name Country/ Indication Month Event Code region Evocalcet Secondary Approved Japan Mar. KHK7580 hyperparathyroidism (BN: Orkedia tablets) Chemotherapy Granisetron Approved induced nausea and Malaysia Jan. ‐ (BN: Sancuso) vomiting May Extended PDUFA goal da
Slide 17: POTELIGEO approved in the US
Key development updates in 18Q3 (1) POTELIGEO® approved in the US Product Information Brand name POTELIGEO® injection Generic name mogamulizumab‐kpkc POTELIGEO is indicated for the treatment of adult patients with Indication relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after
Slide 18: POTELIGEO: Mechanism of action
POTELIGEO®: Mechanism of action – Poteligeo is a defucosylated, humanized IgG1 kappa monoclonal antibody Natural Killer Cell – Poteligeo binds to CCR41, which is involved in the trafficking of Poteligeo lymphocytes to various organs – Enhanced antibody‐dependent cellular cytotoxicity (ADCC) activity
Slide 19: POTELIGEO: Research and Development History
POTELIGEO®: Research and Development History 1996 2012 2018 Initiation of antibody formulation (Collaboration w/ Prof. Matsushima) Approval in Japan 1999‐2000 Related events Research Reports: CCR4 expression on T cell malignancy (Jones et al) CCR4 expression on Th2 cells (Imai et al) 2001 Initiation
Slide 20: Key development updates in 18Q3 (2)
Key development updates in 18Q3 (2) • Discontinued development for mogamulizumab in combination with nivolumab for the treatment of solid tumors based on a collaboration agreement on immuno‐oncology combination therapies with Ono Pharmaceutical © Kyowa Hakko Kirin Co., Ltd. 20
Slide 21: Key development events in 2018 (after October)
Key development events in 2018 (after October) • Initiation of the phase 2 clinical study of KHK4083 for the treatment of atopic dermatitis in Japan, the U.S., Canada, and Germany ClinicalTrials.gov identifier: NCT03703102 Note: Listed events were completed between October 1, 2018 and October 30, 20
Slide 22: Business Topics
Business Topics © Kyowa Hakko Kirin Co., Ltd. 22
Slide 23: Darbepoetin alfa Syringe [KKF]
Darbepoetin alfa Syringe [KKF] Darbepoetin alfa (authorized version of NESP) Approved in Japan CSV management Strong expertise based on our in the renal unique business disease area structure* Currently making preparations to ensure a steady supply (Targeted retail availability: Third quarter of 2
Slide 24: Appendix
Appendix © Kyowa Hakko Kirin Co., Ltd. 24
Slide 25: FOREX Information
FOREX Information Average FOREX Rate [ Yen ] 2017Q3 2018Q3 2018Q4 Currency Changes Results Results Plan USD/JPY 112 109 ‐3 110 EUR/JPY 124 131 +7 130 GBP/JPY 142 149 +7 150 2018Q3 FOREX Effect (YoY) [ Billion Yen] Segment Currency Revenue Core OP USD ‐0.2 ‐0.1 Pharmaceuticals EUR +0.0 +0.0 GBP +1.3
Slide 26: 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
Slide 27: Development schedule of major pipeline
Development schedule of major pipeline As of September 30 +：Estimated time of regulatory decisions Generic name Country/ Indication 2018 2019 2020~ Code region Bardoxolone methyl Diabetic kidney Japan Phase 3 RTA 402 disease Benralizumab1 U.S., Europe TBD COPD KHK4563 Japan TBD Psoriasis Asia Submis
Slide 28: Development schedule of major pipeline (cont.)
Development schedule of major pipeline (cont.) As of September 30 Country/ Code Indication 2018 2019 2020~ region Recurrence of FSGS in Bleselumab de novo kidney U.S. Phase 2 ASKP1240 4 transplant Ulcerative colitis U.S., Europe Phase 2 KHK4083 U.S., Europe, Atopic dermatitis Phase 2 Japan KW‐6356 P
Slide 29: Progress in products under the alliances with partners
Progress in products under the alliances with partners Country/ Product Indication Month Event region Feb. Approved Dovobet Gel Psoriasis Japan Jun. Launched CD20 positive, B‐cell non Hodgkin’s lymphoma Rituximab BS CD20 positive, B‐cell Intravenous lymphoma under Japan Jan. Launched Infusion
Slide 30: Biosimilar product development
Biosimilar product development As of September 30 Development Reference bio medical product Development stage Country/region code Generic name Brand name Phase 2 Phase 3 Application FKB3272 Adalimumab HUMIRA U.S., others 1 FKB2383 Bevacizumab Avastin U.S., Europe, others Not Not Not Not disclosed di
Slide 31: List of acronyms
List of acronyms BS Biosimilar COPD Chronic Obstructive Pulmonary Disease CTCL Cutaneous T‐Cell Lymphoma CKD Chronic Kidney Disease DKD Diabetic Kidney Disease ESRD End Stage Renal Disease FSGS Focal Segmental Glomerulosclerosis ITP Idiopathic (immune) Thrombocytopenic Purpura MF Mycosis Fungoides P
Slide 32: Kyowa Hakko Kirin Group 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