Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — Q1 2016 Earnings Presentation
23 slides from Kyowa Kirin's earnings presentation, 2016
Slide 1: Results Presentation Fiscal 2016 First Quarter
Results Presentation Fiscal 2016 First Quarter (January 1, 2016 – March 31, 2016) Kyowa Hakko Kirin Co., Ltd. © 2015 Kyowa Hakko Kirin Co., Ltd.
Slide 2: Agenda
Agenda FY 2016 Q1 Highlights Financial review Kazuyoshi Tachibana, Managing Executive Officer R & D review Yoichi Sato, Managing Executive Officer, Vice President Head R&D Division 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 Q1 Highlights
FY 2016 Q1 Highlights In Q1 of FY2016, the Pharmaceuticals business saw a decline in sales and profits, and the Bio-Chemicals business saw a decline sales but an increase in profits. Despite a YoY decline in sales and profits on a consolidated basis, we are making steady progress towards H1 plans.
Slide 5: Financial review
Financial review 5 © 2016 Kyowa Hakko Kirin Co., Ltd.
Slide 6: Summary of 2016 Q1 results (consolidated)
Summary of 2016 Q1 results (consolidated) Despite growth in domestic pharmaceutical products, especially new products, sales and profits declined on a consolidated basis due to a decline in technology out- licensing revenue and increased R&D and other expenses. FY2015 Q1 FY2016 Q1 (Unit: ¥bn) Change
Slide 7: Summary of FY2016 Q1 consolidated results: Analysis of YoY profit changes
Summary of FY2016 Q1 consolidated results: Analysis of YoY profit changes 2016 Q1 net profit: Analysis of YoY changes (¥bn) Pharmaceuticals -¥0.8bn Kyowa Hakko Kirin -¥1.8bn (decrease in technology licensing, etc.) Kyowa Kirin International +¥0.9bn Bio-Chemicals +¥0.4bn Kyowa Hakko Bio +¥0.4bn +2.7
Slide 8: Summary of FY2016 Q1 financial results by segment
Summary of FY2016 Q1 financial results by segment In the Pharmaceuticals business, despite growth in domestic products, especially new products, sales and profits declined due to a fall in technology out-licensing revenue. In the Bio-Chemicals business, despite ongoing yen weakness, sales declined b
Slide 9: Pharmaceuticals business: FY2016 Q1 Analysis of YoY changes
Pharmaceuticals business: FY2016 Q1 Analysis of YoY changes Net sales Operating income FY2015 Q1 results 68.0 FY2015 Q1 results 7.7 Domestic sales (parent) +1.7 Gross profits -0.8 Technology licensing (parent) -1.0 SG&A (excl. R&D expenses） +0.5 Overseas sales +0.3 (including KKI*) R&D expenses -1.6
Slide 10: Pharmaceuticals business: Domestic sales of key products
Pharmaceuticals business: Domestic sales of key products Sales of domestic pharmaceutical products increased YoY due to market penetration of new products and growth of key products such as NESP® Product name, FY2015 FY2016 FY2016 Rate of other Q1 Q1 Change Reason for change 1H information achieveme
Slide 11: Bio-Chemicals business: FY2016 Q1: Analysis of YoY profit
Bio-Chemicals business: FY2016 Q1: Analysis of YoY profit Net sales Operating income FY2015 Q1 results 22.1 FY2015 Q1 results 1.4 Overseas sales -0.6 Gross profits Pharmaceutical and +0.4 health food materials +0 SG&A (excl. R&D Consumer products +0.1 expenses) +0.3 Kyowa Pharma Chemical +0.2 R&D ex
Slide 12: R&D review
R&D review 12 © 2016 Kyowa Hakko Kirin Co., Ltd.
Slide 13: Key development events in 2016
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.) Note: Listed events were completed between Jan. 23, 2016 and Apr. 20, 2016. 13 © 2016 Kyowa Hakko Kirin Co., Ltd.
Slide 14: Key global development updates (1) KW-0761 (hematological cancer)
Key global development updates (1) KW-0761 (hematological cancer) 1 Development stage (Scheduled trial completion date) Estimated Indication Country/region enrollment Phase 2 Phase 3 Application Relapsed/ ATL U.S., Europe, others 2 (2016/11) 70 4 refractory Relapsed/ CTCL U.S., Europe, Japan, others
Slide 15: Key global development updates (2) KW-0761 (solid tumor)
Key global development updates (2) KW-0761 (solid tumor) Development stage Country/ Concomitant (Scheduled trial completion date) Estimated Indication region Drug Partner enrollment Phase 1 Durvalumab U.S. (2016/6) AstraZeneca 108 1 or Tremelimumab U.S. PF-05082566 (2018/3) Pfizer 70 2 Solid ONO PHA
Slide 16: Key global development updates (3) KW-6002
Key global development updates (3) KW-6002 1 Development stage (Scheduled trial completion date) Estimated Indication Country/region enrollment Phase 3 Application North America Parkinson’s disease Europe, Others (2016/4) 609 4 Patient numbers: Japan: approx. 140,000 2, U.S.: approx. 570,000 3 1 Lau
Slide 17: Key global development updates (4) KRN23
Key global development updates (4) KRN23 Development stage Estimated Indication Country/region (Scheduled trial completion date) Partner enrollment Phase 2 Phase 3 4 Pediatric U.S., Europe (2017/3) 50 5 U.S. (2016/9) 25 XLH Ultragenyx NA., Europe Adult (2017/3) Pharmaceutical 120 6 Japan, Korea (U.S
Slide 18: List of acronyms
List of acronyms ATL Adult T-cell Leukemia/Lymphoma CCR4 Chemokine (C-C motif) Receptor 4 CTCL Cutaneous T-Cell Lymphoma ENS Epidermal Nevus Syndrome TIO Tumor Induced Osteomalacia XLH X-linked Hypophosphatemia 18 © 2016 Kyowa Hakko Kirin Co., Ltd.
Slide 19: Appendix
Appendix 19 © 2016 Kyowa Hakko Kirin Co., Ltd.
Slide 20: 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 21: Development progress with outlicensed compounds
Development progress with outlicensed compounds Phase Name Partner Filing Remarks I II III Advanced Renal Cell Cancer EU Tivozanib AVEO (VEGF receptor inhibitor) Russia (KRN951) (Anti-IL-5R Asthma antibody) Benralizumab AstraZeneca (KHK4563) (MEDI-563) /MedImmune POTELLIGEN COPD T® Midatech KRN5500
Slide 22: FOREX
FOREX Period average rate Average exchange 2015 Q1 2016 Q1 FY2016 Change rate Results Results H1 Forecast ¥/$ ¥119 ¥117 -¥2 ¥119 ¥/€ ¥138 ¥128 -¥10 ¥137 ¥/£ ¥183 ¥169 -¥14 ¥187 FY2016 Q1 currency effects (YoY) Segment Currency Net sales Operating income Pharmaceuticals business $ -¥0.0bn +¥0.0bn € -
Slide 23: 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