Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — H1 2014 Earnings Presentation
34 slides from Kyowa Kirin's earnings presentation, Jul 31, 2014
Slide 1: Results Presentation Fiscal 2014 Interim
Results Presentation Fiscal 2014 Interim (January 1, 2014 – June 30, 2014) Kyowa Hakko Kirin Co., Ltd. July 31, 2014 1
Slide 2: Agenda
Agenda Financial review Kazuyoshi Tachibana, Tachibana Managing Executive Officer R & D review B i Business overview i Nobuo Hanai, Executive Director of the Board; President and CEO Q & A session 2
Slide 3: Forward-looking statements
Forward-looking statements This document contains certain forward-looking statements relating to such items as the companyʼss (including its domestic and overseas subsidiaries) forecasts company forecasts, targets and plans plans. These forward-looking statements are based upon information available
Slide 4: Financial review
KYOWA KIRIN Financial review ee ——(isSsSCSCis copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 4
Slide 5: Summary of H1 results (consolidated)
Summary of H1 results (consolidated) Compared to FY2013 H1, sales and profits declined due to a decrease in licensing g revenue and effects of the drug g price p revision FY2014 Rate of ((Unit: ¥bn)) FY2013 H1 FY2014 H1 Change f forecast t progress Net sales ‐7.8 169.7 69.7 161.8 6 .8 337.0 48% ( 5%
Slide 6: Analysis of YonY profit changes, H1 net income
Summary of FY2014 H1 results (consolidated): Analysis of YonY profit changes H1 net income: Analysis (¥bn) Pharmaceuticals -¥8.7bn Kyowa y Hakko Kirin (parent) (p ) -¥10.5bn ((drug gpprice revision -¥3.9bn, Biosimilars-related -¥3.0bn, return of Bisuflex development and sales rights -¥2.1bn, decline
Slide 7: Summary of FY2014 H1 financial results by segment
Summary of FY2014 H1 financial results by segment In the Pharmaceuticals business, sales and profits declined due to effects of the drug price revision In the Bio-Chemicals business, sales and profits increased due to expansion of generic APIs and other products (Unit: ¥bn) FY2013 H1 FY2014 H1 Chang
Slide 8: Pharmaceuticals business: Analysis of YonY profit changes
Pharmaceuticals business: FY2014 H1: Analysis of YonY profit changes Net sales Operating income ～ ～ ～ ～ ～ 前年同期 FY2013 H1 129.9 FY2013 H1 24.1 ～ 前年同期 ～ ～ 国内医薬品 Domestic sales (parent) （単体）増減 - 5.4 売上総利益 Gross profits 輸出（単体） 増減 ‐ 8.7 Exports (parent) 増減 + 1.3 技術収入他 SG&A 販管費 (excl (excl. 管費 R&D Technol
Slide 9: Pharmaceuticals business: Domestic sales of key products
Pharmaceuticals business: Domestic sales of key products Some products were impacted by generics and biosimilars, but sales of NESP® and REGPARA® , which are at the core of the nephrology category, exceeded forecasts Product name/ FY2013 H1 FY2014 H1 Change Reason for change Rate of Exports/ p resul
Slide 10: Bio-Chemicals business: Analysis of YonY profit changes
Bio-Chemicals business: FY2014 H1: Analysis of YonY profit changes Net sales Operating income 〜 〜 〜 前年同期 FY2013 H1 3.1 前年同期 FY2013 H1 41 2 41.2 〜 ヘルスケア Healthcare (parent) （単体）増減 + 0.1 売上総利益 Gross profits +1.6 増減 医薬・工業原料 Pharma/ industrial use (parent) （単体）増減 ( t) + 0.6 販管費 海外売上 Overseas sales SG&A
Slide 11: Revision to consolidated full-year forecast for FY2014
Revision to consolidated full-year forecast for FY2014 FY2014 initial FY2014 revised Change (Unit: ¥bn) FY2013 forecast forecast (a) (b) (b) (a) (b)-(a) Net sales 340.6 337.0 337.0 0.0 Operating income 51.7 41.0 45.0 +4.0 Ordinary income 49.5 35.0 37.0 +2.0 Net income 30.0 20.0 20.0 0.0 Main causes
Slide 12: R&D review
KYOWA KIRIN R&D review a copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 12
Slide 13: FY2014 H1: Update on key timeline events
FY2014 H1: Update on key timeline events Domestic （As of July 30, 2014) ☑ Approval for additional indications for humanized CCR4 monoclonal antibody POTELIGEO® ・ Untreated CCR4-positive adult T-cell leukemia/lymphoma1 ・ Relapsed p or refractoryy CCR4-positive p p peripheral p T-cell lymphoma y p ((M
Slide 14: Domestic development and other key updates
Domestic development and other key updates Re-filed application for additional indication of untreated ATL1 for POTELIGEO® Phase 1 trials for KRN23 targeting adults began in Japan and Korea Product Category name/development Mechanism of action, etc. Stage (timing) / Target number b Nephrology RTA 40
Slide 15: Global development update (1) KW-0761
Global development update (1) KW-0761 Indication Country/ Development stage Annual incidence per disease, other region ATL Untreated Japan Re-filing Japan: approx. 1,1001 patients ATL Relapsed/ U.S. Phase 2 Europe, U.S.: Investigating refractory Europe CCR4 positivity was not an inclusion criterion
Slide 16: Global development update (2) KW-6002, KRN23
Global development update (2) KW-6002 Indication Country/ Development Annual incidence per disease, other region stage Parkinson’s disease U.S. Phase３ U.S.: More than 570,000 , 1p patients Europe Special Protocol Assessment agreed with FDA Others KRN23 Indication Country/ Development Annual incidenc
Slide 17: Biosimilars development update
Biosimilars development update Strong progress on Phase 1 trial of FKB327 towards global launch Launch of FKB238 Phase 1 trial this year is proceeding according to plan Development Reference medical product Stage number Biosimilar FKB327 Adalimumab (humira) Phase 1 Biosimilar FKB238 Bevacizumab (ava
Slide 18: Enhance presence in immunology and allergy: Psoriasis
Enhance presence in immunology and allergy Leverage the dermatology network developed through anti-allergy agents such as ALLELOCK® Further enhance presence by sustained launches of new psoriasis drugs Psoriasis Vulgaris treatment Future utu e Dovobet® Current position Anti allergy agent Anti-allerg
Slide 19: Psoriasis pyramid
Psoriasis pyramid Leverage sales synergies between Dovobet® and KHK4827 Psoriasis pyramid Severe ・Vitamin D3 and KHK4827 steroid external Biologics preparations used in all Cyclosporin segments as basal agents Retinoid ・Biologics used in Phototherapy more severe segments Topical Vitamin D3 Topical s
Slide 20: Business overview
KYOWA KIRIN Business overview ee ——(isSsSCSCis copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 20
Slide 21: Highlights
Highlights 1. Maximized the product value of Mogamulizumab (KW-0761) Joint development partnership with AstraZeneca targeting solid tumor 2. Further strengthened European business base Acquisition of Archimedes by ProStrakan 3. Signed domestic sales licensing agreement with Japan Blood Products Orga
Slide 22: Maximize Mogamulizumab product value
Maximize Mogamulizumab product value Combination therapypy of mogamulizumab g with anti-PD-L1 antibody MEDI4736 and anti-CTLA-4 antibody Tremelimumab, targeting solid tumors, with the goal of maximizing mogamulizumab product value KW-0761/mogamulizumab MEDI4736 Tremelimumab anti-CCR4 anti-PD-L1 anti
Slide 23: Hypothesis: anti-tumor activity
Hypothesis: anti-tumor activity T cell Antigen presenting cell C Cancer cell ll MHC TCR TCR MHC B7 CTLA-4 PD-1 PD L1 PD-L1 Tremelimumab MEDI4736 Mogamulizumab CCR4 Treg cell 23
Slide 24: Hypothesis: anti-tumor activity
Hypothesis: anti-tumor activity In cancer immunotherapy, the additive effect of combination therapy is more highly evaluated than monotherapy ve Proporttion Aliv Immunotherapy Combination Immunotherapy Monotherapy Control Chemotherapy / TKI Ti Time from f Treatment T Source: internal documents 24
Slide 25: Acquisition of Archimedes Pharma by ProStrakan
Acquisition of Archimedes Pharma by ProStrakan Archimedes Pharma Overview: O i Specialty S i lt pharmaceutical h ti l company h headquartered d t d iin R Reading, di E England l d Business: Development and sales of ethical pharmaceuticals in Europe, primarily in the areas of pain, oncology, and crit
Slide 26: Further strengthen European business base
Further strengthen European business base Through the acquisition of Archimedes by ProStrakan, strengthen European business base with the aim of driving forward progress toward GSP1 St t i significance Strategic i ifi off acquisition i iti S l Sales P St k sales ProStrakan l outlook tl k Enhancement
Slide 27: Early-stage market penetration of KW-3357
Early-stage market penetration of KW-3357 Sales partnership with Japan Blood Products Organization for KW-3357 KW-3357 KW-3357 •Recombinant human antithrombin drug •Indicated for disseminated intravascular coagulation 192 and congenital antithrombin deficiency. Holds promise for mitigation off the t
Slide 28: Further accelerate global development
Further accelerate global development Actively pursue alliance strategy matched to market characteristics Ensure efficient and effective allocation of R&D expenditure Large-scale •Asthma:KHK4563 areas •Solid tumor: KW-0761 Medium-scale •Hematopoietic organ tumor: KW-0761 areas •Parkinsonʼs Parkinson
Slide 29: Q & A session
KYOWA KIRIN Q & A session copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 29
Slide 30: Group mission and inquiries 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 t h l i technologies. If you have any inquiries regarding this presentation please call: Corporate Communicati
Slide 31: Appendix
KYOWA KIRIN APPENDIX ——a—X——*— ;i—£—~&&&#_—E—E— copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 31
Slide 32: Appendix: POTELLIGENT technology alliances
Appendix: POTELLIGENT® technology alliances (As of July 10, 2014) P d tl Product-level l alliances lli Technology-level alliance Out licensing Joint R&D POTELLIGENT® CHOK1SV Technology licensing (14 companies, including one undisclosed partner) Bristol-Myers Squibb Undisclosed Partner Pfizer *There
Slide 33: Appendix: Development progress with outlicensed compounds
Appendix: Development progress with outlicensed compounds Phase Name Partner Remarks I II III Cancer Tivozanib AVEO ((VEGF receptor p inhibitor)) (KRN951) Asthma (Anti-IL-5R (A ti IL 5R antibody) tib d ) BenralizuMab AstraZeneca (KHK4563) (MEDI-563) /MedImmune POTELLIGENT® COPD KRN5500 DARA Peripher
Slide 34: Appendix: FOREX related
Appendix: FOREX related Period average rate Average FY2013 FY2014 Change 2014 exchange rate H1 results H1 results Jan Dec forecast Jan-Dec ¥/$ ¥94 ¥103 +¥9 ¥102 ¥/€ ¥123 ¥141 +¥18 ¥141 ¥/£ ¥145 ¥171 +¥26 ¥171 FY2014 Q1 currency effects (YoY) Segment Currency Net sales Operating income $ +¥0.4bn +¥0.