Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — H1 2013 Earnings Presentation
34 slides from Kyowa Kirin's earnings presentation, Jul 26, 2013
Slide 1: Notice of revisions to figures in Results Presentation
July 31, 2013 FOR IMMEDIATE RELEASE Listed Company Name: Kyowa Hakko Kirin Co., Ltd. Representative: Nobuo Hanai, President and CEO (Code no.: 4151, First Section of TSE) Inquiries: Shigeru Morotomi, Managing Officer Corporate Communications Department Telephone: +81-3-3282-0009 Notice of revisions
Slide 2: Reference: Original page and revised page
Reference Original page Before revision Revised page After revision
Slide 3: FY ending December 2013 First half results presentation
FY ending December 2013 First half results presentation Nobuo Hanai President and CEO Kyowa Hakko Kirin Co., Ltd. July 26 2013
Slide 4: 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 5: Agenda
Agenda 1. Summary of H1 results 2. Revision of full year forecasts 3. Topics 4. Development pipeline No.3
Slide 6: Summary of H1 results
KYOWA KIRIN Summary of H1 results ee ee ee copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved No.4
Slide 7: Summary of H1 results (consolidated)
Summary of H1 results (consolidated) Sales and profits increased in H1 driven by a good performance by pharmaceutical products in Japan, continued strong growth at ProStrakan, and further weakening of the yen (Unit: ¥bn) FY 2012 H1 FY 2013 H1 Change Net sales 166.2 169.7 +3.4 Operating income 25.5 2
Slide 8: Analysis of YonY profit changes
Summary of H1 consolidated results: Analysis of YonY profit changes ¥bn H1 net income (total): Analysis of YonY changes Pharmaceuticals - ¥0.8bn Kyowa Hakko Kirin (non-consol.) -¥4.4bn 22.0 (Effects of Apr. 2012 drug price reform -¥2.5bn, technology licensing -¥2.2bn, of which: Biosimilar related 20
Slide 9: H1 results by segment
H1 results by segment Sales and profits increased YonY in both Pharmaceuticals business and Bio-Chemicals business （Unit: ¥bn) FY 2012 H1 FY 2013 H1 Change Pharmaceuticals Net sales 127.5 129.9 +2.3 Operating income 23.5 24.1 (Operating margin) +0.5 (18.4%) (18.6%) Bio-Chemicals Net sales 40.0 41.2
Slide 10: Pharmaceuticals Business: Analysis of YonY profit changes
Pharmaceuticals Business: H1 results: Analysis of YonY profit changes (Consolidated) Net sales Operating income ～ ～ ～ ～ FY 12 H1 127.5 FY 12 H1 23.5 ～ ～ ～ ～ Domestic sales (parent) Gross profits -0.8 Exports (Parent) -0.2 Technology SG&A, licensing -2.1 (exc. R&D expenses) +0.2 (parent) Overseas sal
Slide 11: Domestic sales of core pharmaceutical products
Domestic sales of core pharmaceutical products Sales up year on year despite April 2012 reductions in NHI drug prices 2012 H1 2013 H1 Reasons for changes (Unit: ¥bn) Change results results Sales declined due to lower shipments following Nesp 26.8 25.0 -1.8 launch of unified dosage product at end of
Slide 12: Bio-Chemicals Business: Analysis of YonY profit changes
Bio-Chemicals Business: H1 results: Analysis of YonY profit changes (Consolidated) Net sales Operating income ～ ～ ～ ～ FY 12 H1 40.0 FY 12 H1 2.0 ～ ～ ～ ～ Healthcare (parent) -0.6 Pharma/ Gross profits +1.8 Industrial use (Parent) +0.4 SG&A, Overseas sales +2.2 (exc. R&D expenses) -0.6 Dai Ichi Fine C
Slide 13: Revision of full year forecasts
Revision of full year forecasts No.11
Slide 14: Revision of full year forecasts
Revision of full year forecasts FY2013 FY 2013 (Unit: ¥bn) FY 2012 initial revised Difference results forecasts forecasts (b)-(a) (a) (b) Net sales 333.1 338.0 339.0 +1.0 Operating income 52.9 55.0 51.0 -4.0 Ordinary income 49.0 49.0 48.0 -1.0 Net income 24.1 30.0 28.0 -2.0 Assumptions: Average fore
Slide 15: Revision of full year forecasts: Sales
Revision of full year forecasts: Sales FY2013 FY 2013 (Unit: ¥bn) FY2012 initial revised Difference results forecasts forecasts (b)-(a) (a) (b) Net Consolidated 333.1 338.0 339.0 +1.0 sales Pharmaceuticals 259.3 260.0 258.0 -2.0 Bio-Chemicals 76.9 81.0 84.0 +3.0 Eliminations -3.1 -3.0 -3.0 --- As a
Slide 16: Revision of full year forecasts: Operating income
Revision of full year forecasts: Operating income FY2013 FY 2013 (Unit: ¥bn) FY2012 initial revised Difference results forecasts forecasts (b)-(a) (a) (b) Operating Consolidated 52.9 55.0 51.0 -4.0 income Pharmaceuticals 50.7 49.2 45.0 -4.2 Bio-Chemicals 2.1 5.8 6.0 +0.2 Eliminations 0.0 --- --- ---
Slide 17: Topics: Pharmaceuticals Business
Topics: Pharmaceuticals Business No.15
Slide 18: Challenges in the treatment of Parkinson's disease
Challenges in the treatment of Parkinson’s disease Motor complications associated with L-DOPA treatment: Complications brought about by the long-term continuation of L-DOPA treatment (dopamine replacement therapy) that significantly impair patient QOL Wearing-off phenomenon: Reduction in the time
Slide 19: NOURIAST: First In Class Parkinson's Disease treatment
NOURIAST: First In Class Parkinson’s Disease treatment World’s first adenosine A2A receptor antagonist (non-dopaminergic antiparkinsonian agent) •Reduces average “off” time in Parkinson’s patients O CH3 receiving treatment with L-DOPA who are N O CH3 experiencing wearing off phenomenon H3C N •40mg d
Slide 20: Aim to be a leading company in Parkinson's disease
Kyowa Hakko Kirin category strategy Aim to be a leading company in the field of Parkinson’s disease treatment, leveraging our strong position of having four drugs on the market Pathogenesis of Parkinson’s Disease Early stage Intermediate stage Late stage Advanced phase Mechanism of action L-DOPA EC-
Slide 21: Growing domestic market for DPP-4 inhibitors
Growing domestic market for DPP-4 inhibitors 1. Increase in type 2 diabetes patients (￥bn) DPP-4 inhibitor market Patients with severe diabetes 200 1997 6.9 million people 2002 7.4 million people 150 2007 8.9 million people 2007 National Health and Nutrition Survey 2. Increase in ratio of patients w
Slide 22: DPP-4 inhibitor: Onglyza sales forecasts
DPP-4 inhibitor: Onglyza sales forecasts Aiming for ￥21.6bn in domestic Onglyza sales at peak Onglyza Onglyza Sales (￥bn) Market share DPP-4 inhibitor sales No. 2 globally 300 30 30% Onglyza tablet sales オングリザ錠売上 Cardio vascular evidence 250 25 マーケットシェア Market share 25% (Meta –analysis of U.S. clini
Slide 23: KW-0761: Global development
KW-0761: Global development Increase in KW-0761 indications accelerating value maximization Indications Country/ Development stage Annual incidence per disease, other region ATL Relapsed/ Japan* On sale (May 2012) ATL: 1,100 1) refractory ATL Untreated Japan* On file (Jul 2013) ATL: 1,100 1) ATL Rel
Slide 24: Topics: Bio-Chemicals Business
Topics: Bio-Chemicals Business No.22
Slide 25: Investment in production facilities
Investment in production facilities ◆ Facility enhancement associated with Yamaguchi Production Center consolidation at Hofu Sequential consolidation of functions through phased investment After completion of new refining facility in March, break ground for new manufacturing facility in November (co
Slide 26: Development pipeline
KYOWA KIRIN Development pipeline eee copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserve No.24
Slide 27: 2013 H1 Progress in development pipeline
2013 H1 Progress in development pipeline Approval for two new drugs in Japan, including first in class Began clinical trials for Adalimumab biosimilar FKB327 Japan: Sale of NOURIAST ®, a novel anti-Parkinson’s agent (May 2013) Inherited approval from Otsuka for manufacturing and marketing of Ong
Slide 28: Inquiries: Corporate Communications Department
If you have any inquiries regarding this presentation please call: Corporate Communications Department, Kyowa Hakko Kirin Co., Ltd. Tel: +81-3-3282-0009
Slide 29: Appendix
KYOWA KIRIN Appendix Seer ee ee ee copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved
Slide 30: 2013 foreign exchange estimates - assumptions
2013 foreign exchange estimates- assumptions Forex rates 2013 H1 2013 2012 H1 2012 ¥/USD ¥95 ¥ 94 ¥80 ¥ 80 ¥/EUR ¥124 ¥123 ¥103 ¥103 ¥/GBP ¥145 ¥145 ¥127 ¥126 Foreign exchange effects 1H 2013 (Year on year) (unit: Y million) Segment Conversion Net sales Operating income currency Pharmaceuticals USD
Slide 31: Development progress with outlicensed compounds
Development progress with outlicensed compounds Phase Name Partner Remarks I II III Cancer Tivozanib AVEO (VEGF receptor inhibitor) (KRN951) Asthma (Anti-IL-5R antibody) MEDI-563 MedImmune (KHK4563) POTELLIGENT® KRN5500 DARA Peripheral neuropathy RGI2001 REGiMMUNE Phase1/2 Immunosuppressive Ulcerati
Slide 32: NOURIAST: Phase III clinical trial design
NOURIAST: Phase III clinical trial design Participants: 373 Parkinson’s patients with associated motor complications (wearing off) who are receiving treatment with levodopa Method: Multicenter, placebo-controlled, randomized, double-blind, parallel-group trial Randomly assigned study patients receiv
Slide 33: NOURIAST: Change in average off time per day
NOURIAST: Change in average “off” time per day NOURIAST®20mg NOURIAST®40mg Placebo group group group (h) （n=123） （n=120） （n=123） 0 Change in average “off” time per day -0.23 -0.2 [-0.62、0.16] -0.4 -0.99 -0.96 -0.6 -0.8 -1 ＊ ＊ [-1.38、-0.60] [-1.35、-0.58] -1.2 -1.4 -1.6 Least mean square value (95%C.I
Slide 34: KW-0761: Results of phase II clinical trial
KW-0761: Results of phase II clinical trial Target New onset untreated ATL (CCR4-positive) Dosage ◇mLSG15+KW-0761 group schedule mLSG15 treatment＋1.0mg/kg dosage intravenously eight times at two-week intervals ◇mLSG15 group mLSG15 treatment Efficacy Complete response rate ◇mLSG15+KW-0761 group: 52%