Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — H1 2016 Earnings Presentation
42 slides from Kyowa Kirin's earnings presentation, 2016
Slide 1: Results Presentation Fiscal 2016 Interim
Results Presentation Fiscal 2016 Interim (January 1, 2016 – June 30, 2016) Kyowa Hakko Kirin Co., Ltd. © 2016 Kyowa Hakko Kirin Co., Ltd.
Slide 2: Agenda
Agenda FY2016 H1 highlights Nobuo Hanai, Ph.D., President and CEO Financial review Kazuyoshi Tachibana, Managing Executive Officer R & D review Nobuo Hanai, Ph.D., President and CEO Q & A session 2 © 2016 Kyowa Hakko Kirin Co., Ltd.
Slide 3: Forward-looking statements
Forward-looking statements This document contains certain forward-looking statements relating to such items as the companyʼs (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: FY 2016 H1 highlights
FY 2016 H1 highlights In H1 of FY2016, despite a YoY decline in sales and profits, the Pharmaceuticals business saw an increase in sales and profits ahead of H1 plans, and in the Bio-Chemicals business, performance was largely in line with plans. In the Pharmaceuticals business, Japan sales increa
Slide 5: Financial review
Financial review 5 © 2016 Kyowa Hakko Kirin Co., Ltd.
Slide 6: Summary of 2016 H1 results (consolidated)
Summary of 2016 H1 results (consolidated) Despite growth in domestic pharmaceutical products, sales and profits declined on a consolidated basis due to the strong yen, lower technology revenue and increased R&D and other expenses. FY2015 H1 FY2016 H1 FY2016 Rate of （Unit: ¥bn） Change results results
Slide 7: Analysis of YoY profit changes
Summary of FY2016 H1 consolidated results: Analysis of YoY profit changes 2016 H1 net profit: Analysis of YoY changes (¥bn) Pharmaceuticals -¥4.2bn Decrease in impairment loss +¥3.2bn Kyowa Hakko Kirin -¥5.5bn Gain on sale of fixed assets +¥2.9bn (decrease in technology revenue, etc.) Gain o
Slide 8: Summary of FY2016 H1 financial results by segment
Summary of FY2016 H1 financial results by segment In the Pharmaceuticals business, despite growth in domestic products, especially new products, sales and profits declined due to the drug price revision, lower technology out-licensing revenue, increased R&D expenses. In the Bio-Chemicals businesses,
Slide 9: Pharmaceuticals business: FY2016 H1 Analysis of YoY changes
Pharmaceuticals business: FY2016 H1 Analysis of YoY changes Net sales Operating income FY2015 H1 results 135.3 FY2015 H1 results 18.5 Domestic sales +1.5 (parent) Gross profits - 4.2 Technology licensing (parent) - 3.3 SG&A (excl. R&D expenses） +0.4 Overseas sales +0.1 (including KKI*) R&D expenses
Slide 10: Pharmaceuticals business: Domestic sales of key products
Pharmaceuticals business: Domestic sales of key products Despite impact of the drug price revision, sales of domestic pharmaceutical products increased YoY due to expansion of the new product lineup and growth of key products such as NESP® Product name, FY2015 FY2016 FY2016 Rate of other H1 H1 Chang
Slide 11: Bio-Chemicals business: FY2016 H1 Analysis of YoY profit
Bio-Chemicals business: FY2016 H1: Analysis of YoY profit Net sales Operating income FY2015 H1 results 45.0 FY2015 H1 results 3.9 Overseas sales - 1.4 Gross profits Pharmaceutical and ‐ 1.0 health food materials ‐ 0.1 SG&A (excl. R&D Consumer products +0.2 expenses) +0.5 Kyowa Pharma Chemical ‐0 R&D
Slide 12: Revision to forecasts: Consolidated forecasts for FY2016
Revision to forecasts: Consolidated forecasts for FY2016 (full year) FY2016 FY2016 FY2015 forecast forecast Change (Unit: ¥bn) results released on released on (b)-(a) 29/1 (a) 21/7 (b) Net sales 364.3 351.0 344.0 -7.0 Operating income 43.7 30.0 32.0 +2.0 Ordinary income 39.2 25.0 26.0 +1.0 Net profi
Slide 13: Revision to forecasts: Forecasts for FY2016 by segment
Revision to forecasts: Forecasts for FY2016 (full year) by segment FY2016 FY2016 FY2015 forecast forecast （Unit: ¥bn） Change results released on released on 29/1 (a) 29/7 (b) Net sales 279.2 268.0 264.0 ‐4.0 Pharmaceuticals business Operating income 36.2 23.0 27.5 +4.5 Operating 13.0% 8.6% 10.4% mar
Slide 14: Revision to forecasts: Consolidated net profit
Revision to forecasts: Consolidated forecast of FY2016 (full year) Net profit: Comparison between previous and current 2016 full year forecasts (¥bn) Pharmaceuticals +¥6.0 Kyowa Kirin International -¥3.9 Currency related +¥9.3 Gain on sale of fixed assets +¥2.7bn Bio-Chemicals +¥1.0 Currency
Slide 15: R&D review
R&D review 15 © 2016 Kyowa Hakko Kirin Co., Ltd.
Slide 16: Key development events in 2016: Domestic
Key development events in 2016 Domestic: Announcement of results of interim efficacy analysis of Phase 2 clinical study of RTA 402 targeting chronic kidney disease with type-2 diabetes (May) Initiation of Phase 2 study of KHK4563 targeting eosinophilic chronic rhinosinusitis (June) Approval re
Slide 17: Key development events in 2016: Overseas
Key development events in 2016 Overseas: Initiation of Phase 1/2 trials of Nivolumab (Bristol-Myers Squibb) in combination with KW-0761 targeting solid tumors (February, U.S.) Announcement of results from Phase 3 trials of Benralizumab/KHK4563 targeting asthma (May) Announcement of results fro
Slide 18: Key domestic development updates (1) RTA 402
Key domestic development updates (1) RTA 402 Development stage (Scheduled (Scheduled trial trial completion completion date) date) Estimated Estimated Indication Indication Country/region Country/region enrollment enrollment Phase 2 Phase 3 1 Chronic kidney Japan (2017/12) 108 disease with diabetes
Slide 19: RTA 402: Bardoxolone methyl
RTA 402: Bardoxolone methyl RTA 402 activates Keap1/Nrf2 system 1. Increases the expression of antioxidant genes and removes excess reactive oxygen species 2. Shows anti-inflammatory effect through suppression of NF-κB activation and/or pro-inflammatory cytokine production AIMs: antioxidant inflam
Slide 20: RTA 402: Phase 2 clinical study design and status
RTA 402: Phase 2 clinical study design and status A Randomized, Double-blind, Placebo-controlled RTA 402 Clinical Trial in Patients with Chronic Kidney Disease and Type 2 Diabetes (TSUBAKI study) Efficacy primary endpoint: Changes in glomerular filtration rate after 16 weeks of study drug administra
Slide 21: LUMICEF approved in Japan
Key domestic development updates (2) LUMICEF® approved in Japan LUMICEF® Subcutaneous Injection 210 mg Syringe (code name: KHK4827, generic name: Brodalumab (Genetical Recombination)) has been approved in Japan since July 4, 2016, the first approval of the product worldwide 21 © 2016 Kyowa Hakko Kir
Slide 22: LUMICEF: Mechanism of action
LUMICEF®: Mechanism of action LUMICEF®: Mechanism of Action LUMICEF® selectively binds with IL-17 receptor A, and improves the symptoms of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma, by inhibiting the activities that IL-17A, IL-17F, IL-17A/F and IL-17C
Slide 23: LUMICEF: Product information
LUMICEF®: Product information Brand name LUMICEF® Subcutaneous injection 210mg Syringe Generic name Brodalumab (Genetical recombination) The following diseases that respond inadequately to Indication existing therapies: Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic eryth
Slide 24: Key global development updates (1) KHK4083
Key global development updates (1) KHK-4083 Development stage (Scheduled trial completion date) Estimated Indication Country/region enrollment Phase 2 Phase 3 2 Ulcerative Colitis North America and Europe (2018/9) 60 Estimated no. of patients: U.S. : approx. 650,000 1 patients 1 Diagnosed Prevalent
Slide 25: KHK4083: Anti-OX40 Fully Human Antibody
KHK4083: Anti-OX40 Fully Human Antibody KHK4083: A fully human antibody targeting OX40 created using human antibody-producing technology. It has the POTELLIGENT® technology-enhanced ADCC activity and antagonist activity against the OX40 ligand function. OX40: A molecule in the TNF receptor superfami
Slide 26: KHK4083: Phase II study design
KHK4083 : PHASE II STUDY DESIGN KHK4083 Phase II clinical trial Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study of an Anti-OX40 Fully Human Antibody (KHK4083) in Subjects With Active Ulcerative Colitis KHK4083 Allocation 52 weeks of administration Placebo Efficacy primary
Slide 27: Key global development updates (2) KW-0761 (hematological cancer)
Key global development updates (2) KW-0761 (hematological cancer) 1 Development stage (Scheduled trial completion date) Estimated Indication Country/region enrollment Phase 2 Phase 3 Application Relapsed/ 4 ATL U.S., Europe, others 2 (2016/11) 71 refractory Relapsed/ 5 CTCL refractory U.S., Europe,
Slide 28: Key global development updates (3) KW-0761 (solid tumor)
Key global development updates (3) KW-0761 (solid tumor) Development stage Country/ Concomitant (Scheduled trial completion date) Estimated Indication region Drug Partner enrollment Phase 1 1 Durvalumab U.S. (2017/11) AstraZeneca 108 or Tremelimumab 2 U.S. PF-05082566 (2018/12) Pfizer 70 3 Solid ONO
Slide 29: Key global development updates (4) KW-6002 Parkinson's disease
Key global development updates (4) KW-6002 1 Development stage (Scheduled trial completion date) Estimated Indication Country/region enrollment Phase 3 Application North America 4 Parkinson’s disease Europe, Others (2016/11) 609 Patient numbers: Japan: approx. 140,000 2, U.S.: approx. 570,000 3 1 La
Slide 30: Key global development updates (5) KRN23
Key global development updates (5) KRN23 Development stage (Scheduled trial completion date) Estimated Indication Country/region Partner enrollment Phase 2 Phase 3 2 U.S., Europe (2017/3) 50 Pediatric 3 U.S. (2017/12) 10 Ultragenyx XLH U.S. (2016/9) Pharmaceutical 25 4 (U.S., Europe) Adult North Ame
Slide 31: Key global development updates (5) KRN23
Key global development updates (5) KRN23 Development stage (Scheduled trial completion date) Estimated Indication Country/region Partner enrollment Phase 2 Phase 3 3 U.S. (2016/9) Ultragenyx 15 TIO/ENS Pharmaceutical Japan / Korea (2017/7) (U.S., Europe) 6 4 Estimated no. of patients: TIO/ENS Japan:
Slide 32: KRN23 received breakthrough therapy designation from FDA
KRN23 Anti-FGF23 fully human antibody (KRN23) received breakthrough therapy designation for pediatric X-linked hypophosphatemia from FDA.1 What is the Breakthrough Therapy Designation? Designation criteria The designation may be granted to the drugs that are intended to treat a serious or life threa
Slide 33: Appendix
Appendix 33 © 2016 Kyowa Hakko Kirin Co., Ltd.
Slide 34: Revisions to forecasts: Pharmaceuticals Business
Revisions to forecasts: Pharmaceuticals Business Changes from 2016 H2 forecasts Net sales Operating income Figure released Figure released on Jan. 29 139.0* on Jan 29 17.8* Domestic sales (parent) ‐ 0.8 Gross profits ‐ 4.8 Technology licensing +0.1 (parent) SG&A (excl. R&D expenses） +1.3 Overseas sa
Slide 35: Revisions to forecasts: Bio-Chemicals Business
Revisions to forecasts: Bio-Chemicals Business Changes from 2016 H2 forecasts Net sales Operating income Figure released on Jan. 29 44.0* Figure released on Jan. 29 3.2* Overseas sales ‐ 3.3 Gross profits ‐ 2.6 Pharmaceutical and +0 health food materials SG&A (excl. R&D Consumer products ‐ 0.1 expen
Slide 36: Agreement for the clinical development of anti-LIGHT monoclonal antibody
Agreement for the clinical development of anti-LIGHT monoclonal antibody Entered into an agreement with Medgenics over development of anti-LIGHT monoclonal antibody for severe pediatric onset inflammatory bowel disease (IBD) Compound properties: Human monoclonal antibody which binds the cytokine L
Slide 37: Biosimilar products development update
Biosimilar products development update Development Reference bio medical product Country/ Development stage code region Generic name Brand name Phase 1 Phase 2 Phase 3 1 FKB327 Adalimumab HUMIRA U.S., others United 2 FKB238 Bevacizumab Avastin Kingdom Not Not Not Not Determined disclosed disclosed d
Slide 38: Development progress with outlicensed compounds
Development progress with outlicensed compounds Phase Name Partner Filing Remarks I II III Advanced Renal Cell Cancer Tivozanib AVEO EU (VEGF receptor inhibitor) (KRN951) Asthma (Anti-IL-5R antibody) Benralizumab AstraZeneca (KHK4563) (MEDI-563) /MedImmune POTELLIGENT® COPD Midatech Pharma KRN5500 P
Slide 39: FOREX Average Exchange Rate and Currency Effects
FOREX Average Exchange Rate FY2016 Average exchange 2015 Q2 2016 Q2 Change H1 Forecast rate Results Results released on 29/1 ¥/$ ¥120 ¥114 -¥6 ¥119 ¥/€ ¥135 ¥127 -¥8 ¥137 ¥/£ ¥183 ¥165 -¥18 ¥187 FY2016 H1 Currency Effects (YoY) Segment Currency Net sales Operating income $ -¥0.06bn +¥0.28bn Pharmace
Slide 40: FOREX Forecasts of Annual Currency Exchange Rate in 2016
FOREX Forecasts of Annual Currency Exchange Rate in 2016 Previous Current Exchange Forecast Forecast Change FY2016 Rate Released on Released on (b)-(a) H2 Forecast Jan. 29 (a) July 29 (b) ¥/$ ¥119 ¥109 -¥10 ¥103 ¥/€ ¥137 ¥121 -¥16 ¥114 ¥/£ ¥187 ¥150 -¥37 ¥135 Estimated Exchange Rate Sensitivity of t
Slide 41: List of acronyms
List of acronyms ADCC Antigen Dependent Cellular Cytotoxicity ATL Adult T-cell Leukemia/Lymphoma CCR4 Chemokine (C-C motif) Receptor 4 CTCL Cutaneous T-Cell Lymphoma ENS Epidermal Nevus Syndrome Keap1 Kelch-like ECH-associated protein 1 NF-E2 Nuclear factor erythroid 2 Nrf2 NF-E2-related factor 2 TI
Slide 42: The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being
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. If you have any inquiries regarding this presentation please call: Corporate Communications Depa