Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — H1 2015 Earnings Presentation
35 slides from Kyowa Kirin's earnings presentation, Aug 3, 2015
Slide 1: Results Presentation Fiscal 2015 Interim
Results Presentation Fiscal 2015 Interim Kyowa Hakko Kirin Co., Ltd. August 3, 2015
Slide 2: 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 3: Agenda
Agenda FY2015 H1 Highlights Nobuo Hanai, President and CEO Financial review Kazuyoshi Tachibana, Managing Executive Officer R & D review Topics Nobuo Hanai, President and CEO Q & A session © 2015 Kyowa Hakko Kirin Co., Ltd. 3
Slide 4: FY 2015 H1 Highlights
FY 2015 H1 Highlights In H1 of the final year of the medium-term business plan, the Pharmaceuticals business saw increases in sales and profits, whereas the Bio-Chemicals business saw an increase in sales and a decline in profits, resulting overall in an increase in sales and profits on a consolidat
Slide 5: Financial review
Financial review © 2015 Kyowa Hakko Kirin Co., Ltd. 5
Slide 6: Summary of 2015 Q2 results
Summary of 2015 Q2 results Sales and profits increased YoY on a consolidated basis due to the growth of domestic products and other factors despite increased R&D expenses in the Pharmaceuticals business FY2014 Q2 FY2015 Q2 FY2015 Rate of （Unit: ¥bn） Change results results forecast progress Net sales
Slide 7: Analysis of YoY profit changes
Summary of FY2015 Q2 consolidated results: Analysis of YoY profit changes Q2 net income: Analysis of YoY changes (¥bn) Pharmaceuticals -¥5.7bn Kyowa Hakko Kirin (parent) -¥0.9bn (increase in R&D expenses, etc.) ProStrakan -¥4.4bn (Archimedes, currency effects, etc.) 20 Bio-Chemicals -¥0.8bn Kyowa Ha
Slide 8: Summary of FY2015 Q2 financial results by segment
Summary of FY2015 Q2 financial results by segment In the Pharmaceuticals business, sales and profits increased due to growth of domestic products, in particular new products, and other factors. In the Bio-Chemicals business, growth in amino acids for overseas supplements and for infusion-use and oth
Slide 9: Pharmaceuticals business: Analysis of YoY profit changes
Pharmaceuticals business: FY2015 Q2: Analysis of YoY profit changes Net sales Operating income FY2014 Q2 results 119.5 FY2014 Q2 results 14.1 Domestic sales +8.0 Gross profits +10.1 (parent) Technology licensing -0.3 SG&A (excl. R&D (parent) expenses） -3.3 Overseas sales (including ProStrakan) +8.3
Slide 10: Pharmaceuticals business: Domestic sales of key products
Pharmaceuticals business: Domestic sales of key products While sales were affected by the drug price revision in the previous year and the market penetration of generics, sales increased year on year as a result of the market penetration of new products and growth of key products such as NESP® Produ
Slide 11: Bio-Chemicals business: Analysis of YoY profit changes
Bio-Chemicals business: FY2015 Q2: Analysis of YoY profit changes Net sales Operating income FY2014 Q2 44.0 FY2014 Q2 4.2 Overseas sales +1.9 Pharma/ industrial Gross profits +0.6 use (parent) -1.2 SG&A (excl. R&D Healthcare (parent) +0.2 expenses) -0.9 Daiichi Fine Chemical -0.3 R&D expenses +0.1 O
Slide 12: Revision to forecasts: Consolidated forecast for FY2015
Revision to forecasts: Consolidated forecast for FY2015 (full year) FY2015 FY2015 forecast forecast Change (Unit: ¥bn) FY2014 disclosed 30/1 disclosed 24/7 (b)-(a) (a) (b) Net sales 333.4 354.0 360.0 +6.0 Operating income 36.1 41.5 47.0 +5.5 Ordinary income 29.5 34.0 41.0 +7.0 Net income 15.8 18.5 2
Slide 13: Revision to forecasts: Net income comparison
Revision to forecasts: Consolidated forecast of FY2015 (full year) Net income: Comparison between old and current 2015 full year forecast (¥bn) Lower losses from equity Compensation accounted affiliates, etc. income +¥0.6, etc. 30 +7.5 +1.5 +0.5 25 +6.0 -0.5 20 Pharmaceuticals -¥1.0 Lower tax burden
Slide 14: R & D review
R & D review © 2015 Kyowa Hakko Kirin Co., Ltd. 14
Slide 15: Key development events timeline
Key development events timeline Domestic: ☑ Initiation of Phase 2 trials of RTA 402 targeting chronic kidney disease with type-2 diabetes (March) ☑ Initiation of Phase 1 trials of Nivolumab (ONO PHARMACEUTICAL CO., LTD/Bristol- Myers Squibb) in combination with KW-0761 (brand name in Japan: POTELIGE
Slide 16: Key domestic development updates (1)
Key domestic development updates (1) KHK4827 Development stage Country/ (Scheduled trial completion date) # of Indication enrollment region Phase 2 Phase 3 Application Psoriasis Japan 2015/2 2015/7 1452 Estimated number of patients Japan: approx. 550,0001 1 Investigation of psoriasis using of Nation
Slide 17: Key domestic development updates (2)
Key domestic development updates (2) KW-3357 Country/ Development stage # of Indication region Phase 3 Application Approval enrollment DIC accompanied by a decrease in 4 AT/Thrombilia due to CAD* Japan 2013/5 2014/7 2015/72 2213 Estimated number of patients Japan: approx. 48,0001 1 Calculated based
Slide 18: Key global development updates (1)
Key global development updates (1) KW-0761 (hematological cancer) Development stage Country/ (Scheduled trial completion date) Estimated Indication enrollment region Phase 2 Phase 3 Application Approval Untreated Japan 2014/122 ATL Relapsed/ Japan 2012/32 refractory U.S., Europe, others1 (2015/8) 70
Slide 19: Key global development updates (2)
Key global development updates (2) KW-0761 (solid tumor) Development stage Country/ Concomitant (Scheduled trial completion date) Estimated Indication Partner enrollment region Drug Phase 1 MEDI4736 (2016/6) 1081 U.S. AstraZeneca or Tremelimumab U.S. PF-05082566 (2018/6) Pfizer 702 Solid ONO PHARMAC
Slide 20: Key global development updates (3)
Key global development updates (3) KW-6002 Development stage Country/ (Scheduled trial completion date) Estimated Indication enrollment region Phase 2 Phase 3 Application Approval Japan 2013/31 Parkinson’s disease North America, Europe, (2016/2) 6094 others Patient numbers Japan: approx. 140,0002 U.
Slide 21: Key global development updates (4)
Key global development updates (4) KRN23 Development stage Country/ (Scheduled trial completion date) Estimated Indication Partner enrollment region Phase 1 Phase 2 Pediatric U.S., Europe (2017/3) 504 XLH U.S. (2016/9) Ultragenyx 255 Adult Pharmaceutical Japan, Korea (2015/12) (U.S., Europe) 156 Tum
Slide 22: Biosimilar pharmaceutical products development update
Biosimilar pharmaceutical products development update Reference bio medical product Development stage Development Country/ code Generic name Brand name region Phase 1 Phase 2 Phase 3 1 FKB327 Adalimumab HUMIRA U.S., others FKB238 Bevacizumab Avastin United Kingdom Determined Not disclosed Not disclo
Slide 23: Topics
Topics © 2015 Kyowa Hakko Kirin Co., Ltd. 23
Slide 24: Topics
Topics 1. Approval for marketing authorization of KW-3357 (ACOALAN®) in Japan - Collaboration with Japan Blood Products Organization 2. Maximize product value of KHK4563 - Collaboration with AstraZeneca in Japan market 3. Maximize product value of Biosimilar FKB238 - Collaboration with AstraZeneca ©
Slide 25: Approval for marketing authorization of KW-3357 (ACOALAN) in Japan
Approval for marketing authorization of KW-3357 (ACOALAN®) in Japan Following NHI drug price listing, the drug will be launched in line with the 2014 sales agreement with Japan Blood Products Organization. Features: Developed using KHK’s unique sugar-chain control technology, KW-3357 is the world’s
Slide 26: Maximize product value of KHK4563
Maximize product value of KHK4563 Signed option agreement with AstraZeneca with the objective of maximizing product value of KHK4563 in Japan market. Aiming for significant market penetration. Responsible for Remain responsible for marketing and sales in development of KHK4563 Japan, if option right
Slide 27: Maximize product value of FKB238
Maximize product value of FKB238 AstraZeneca and Fujifilm Kyowa Kirin Biologics will establish a new company under the scheme below to advance global development and sales of FKB238. Fujifilm Kyowa Kirin Biologics Investment of US$90m US$45m if 50:50 ownership split one-off payment between the two c
Slide 28: Q & A session
Q & A session © 2015 Kyowa Hakko Kirin Co., Ltd. 28
Slide 29: List of acronyms
List of acronyms AT Antithrombin ATL Adult T-cell Leukemia/Lymphoma CAD Congenital Antithrombin Deficiency CCR4 Chemokine ( C-C motif ) Receptor 4 COPD Chronic Obstructive Pulmonary Disease CTCL Cutaneous T-Cell Lymphoma DIC Disseminated Intravascular Coagulation ENS Epidermal Nevus Syndrome TIO Tum
Slide 30: Kyowa Hakko Kirin Group mission and 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. If you have any inquiries regarding this presentation please call: Corporate Communications Depa
Slide 31: APPENDIX
APPENDIX © 2015 Kyowa Hakko Kirin Co., Ltd. 31
Slide 32: Revisions to forecasts: Pharmaceuticals Business
Revisions to forecasts: Pharmaceuticals Business Changes from 2015 (H2) forecasts Net sales Operating income Figure released on Jan. 30 140.0* Figure released on Jan. 30 20.0* Domestic sales (parent) -0.6 Gross profits +4.1 Technology licensing (parent) +5.2 SG&A (excl. R&D expenses) -0.4 Overseas s
Slide 33: Revisions to forecasts: Bio-Chemicals Business
Revisions to forecasts: Bio-Chemicals Business Changes from 2015 (H2) forecasts Net sales Operating income Figure released on Jan. 30 45.0* Figure released on Jan. 30 5.0* Overseas sales -1.4 Gross profits -0.4 Pharma/ industrial use -0.2 SG&A (excl. R&D Healthcare -0.3 expenses) +0.2 Daiichi Fine C
Slide 34: Development progress with outlicensed products
Development progress with outlicensed Changes from 2015 (H2) forecasts Phase Name Partner Remarks I II III Cancer Tivozanib AVEO (VEGF receptor inhibitor) (KRN951) Asthma (Anti-IL-5R Benralizumab AstraZeneca antibody) (MEDI-563) /MedImmune (KHK4563) POTELLIGENT® COPD KRN5500 DARA Peripheral neuropat
Slide 35: FOREX related
FOREX related Period average rate Average exchange FY2014 H1 2015 H1 Change FY2015 full-year Forecast rate Results Results ¥/$ ¥103 ¥120 +¥17 ¥120 ¥/€ ¥141 ¥135 -¥6 ¥133 ¥/£ ¥171 ¥183 +¥12 ¥181 FY2015 interim currency effects (YoY) Segment Currency Net sales Operating income Pharmaceuticals $ +¥0.8b