Kyorin Pharmaceutical Co.,ltd. · TSE:4569
Kyorin Pharmaceutical Co.,ltd — H1 FY2014 Earnings Presentation
29 slides from Kyorin Pharmaceutical Co.,ltd's earnings presentation, Nov 5, 2014
Slide 1: Interim Term Financial Results Ended September 2014
Interim Term Financial Results Ended September 2014 November 5 , 2014 g Inc. KYORIN Holdings, President Masahiro Yamashita
Slide 2: Outline of Consolidated Financial Results for the Interim Term
Outline of Consolidated Financial Results for the Interim Term Ended S t b 2014 September Trends of mainstay products and Status of generic drugs Status of development pipeline Consolidated Financial Results Forecast for the Year Ending March 31 2015 and Dividends 1
Slide 3: Outline of Consolidated Financial Results for the Interim Term Ended September 2014
Outline of Consolidated Financial Results for the Interim Term Ended September 2014 2
Slide 4: Outline of Consolidated Financial Results for the Interim Term Ended September 2014
Outline of Consolidated Financial Results for the Interim Term Ended September 2014 （unit : ¥billion） Change % Y/Y Change Sep/13 Sep/14 (actual) (forecast) Net Sales 50.9 51.1 ＋0.2 ＋0.5 －0.2 Operating Income 6.2 4.6 －1.6 －26.2 －0.9 Ordinary O di Income 6.5 4.9 －1.6 －25.0 －0.8 Net Income 44 4.4 35 3.
Slide 5: Segment Sales (Consolidated)
Segment Sales (Consolidated) （unit : ¥billion） Change % Y/Y Change Sep/13 Sep/14 (actual)) (actua ((forecast) o ecast) Net Sales 50.9 51.1 ＋0.2 ＋0.5 －0.2 50.0 50.5 ＋0.5 ＋1.0 －0.1 42.9 40.8 －2.1 －4.9 －1.3 Sales of Ethical new drugs ethical Japan 41.7 40.4 －1.3 －3.1 －1.3 drugs business O Overseas 12 1
Slide 6: Breakdown of Gain and Loss
Breakdown of Gain and Loss （unit : ¥billion） Change % Y/Y Change Sep/13 p Sep/14 p (actual) (forecast) Net Sales 50.9 51.1 ＋0.2 ＋0.5 －0.2 Cost of Sales 19.1 21.3 ＋2.2 ＋11.7 － SG&A 25.5 25.2 －0.3 －1.4 － R&D expenses 6.1 6.7 ＋0.6 ＋9.1 ＋1.0 SG&A expenses 19 4 19.4 18 5 18.5 09 －0.9 47 －4.7 － Operating
Slide 7: Highlights of Business Performance
Highlights of Business Performance （Units: ¥billion） ¾Net Sales increased ¥0.2billion year 50 on year. Cost of Sales Cost of Sales ・decrease of new ethical drugs sales. ・increase of generic drugs sales. 19.1 21.3 ¾Cost of Sales increased ¥2.2 billion. 40 Cost of Sales Ratio Cost of Sales Ratio (Cost
Slide 8: Mainstay Product Sales
Mainstay Product Sales （unit : ¥billion） Change % Y/Y Change Sep/13 Sep/14 (actual) (forecast) Kipres 17 1 17.1 17 4 17.4 ＋0 3 ＋0.3 ＋2 0 ＋2.0 ＋0 1 ＋0.1 Mucodyne 8.2 6.2 －2.0 －24.8 －1.0 Pentasa 9.4 8.6 －0.8 －8.1 －0.3 U it Uritos 37 3.7 34 3.4 03 －0.3 99 －9.9 03 －0.3 Flutiform － 0.9 ＋0.9 ― ＋0.1 7
Slide 9: Trends of mainstay products and Status of generic drugs
Trends of mainstay products and Status of generic drugs 8
Slide 10: Ethical Drug Business
Ethical Drug Business （unit : ¥billion） 110.0 105.5 105.9 105.7 100.8 Pharma Complex Model （PC Model） 100.0 96.9 96.7 12.0 12.7 10.1 15.0 91.0 90 0 90.0 8.9 8.7 ■New drugs group 8.6 ・Maximize uptake of Kipres, Uritos, Flutiform 80.0 ・Enhance the Development Pipeline (KRP-AB1102) 70.0 44.6 41.9 39.1
Slide 11: Kipres: Bronchial asthma and allergic rhinitis treatment
■New drugs group Kipres 【Bronchial asthma and allergic rhinitis treatment】 （unit : ¥billion） ¾Status in first half 2014 45 ■LT antagonists market ： 2% reduction 39.6 40.2 40.3 40.2 ¥57.5bln（FY13 first half） ⇒ ¥56.2bln（FY14 first half） ※1 40 36 8 36.8 ■share of Kipres sales 35 34.5 35.7%（FY13 first h
Slide 12: Uritos: Overactive bladder
■New drugs group Uritos 【Overactive bladder】 （unit : ¥billion） ¾Status in first half 2014 9 ■OAB market ： expand 3% 8.1 8.2 ¥36.6bln （FY13 first half） ⇒ ¥37.8bln （FY14 first half） ※1 8 7.5 7.5 ■share of Uritos sales 11.0% （FY13 first half） ⇒ 10.3% （FY14 first half） ※2 7 6.3 6 5.5 4.4 4.5 ¾effort for
Slide 13: Flutiform: Anti-asthmatic
■New drugs group Flutiform 【Anti-asthmatic】 ¾Status in first half 2014 FY2014 first half sales：¥0.9bln（original＋¥0.1bln ） Flutiform 50 Aerosol - 56 inhalations Flutiform 50 Aerosol - 120 inhalations Flutiform 125 Aerosol - 56 inhalations Flutiform 125 Aerosol - 120 inhalations approval September 201
Slide 14: Mucodyne: Mucoregulating drug
■Original products group Mucodyne【 Mucoregulating drug】 （unit : ¥billion） ¾Status in first half 2014 25 ■ expectorant market： 11% reduction ¥20.0bln（FY13 first half） ⇒ ¥17.7bln（FY14 first half） ※1 21.3 21.5 ■share of Mucodyne sales in expectorant market 20 19.1 18.4 45.8%（FY13 first half ） ⇒ 41.3% （
Slide 15: Pentasa: Ulcerative colitis and Crohn's disease treatment
■Original products group Pentasa 【 Ulcerative colitis and Crohn’s disease treatment 】 （unit : ¥billion） ¾Status in first half 2014 20 19.4 ■market（Mesalazine etc.）： expand 2％ 18.0 18.6 17.6 17.5 ¥18.6bln（FY13 first half ） ⇒ ¥18.9bln（FY14 first half ） ※1 16 7 16.7 ■share of Pentasa sales 53.9%（FY13 f
Slide 16: Status of Generic Drugs
■Generic drugs group Status of Generic Drugs g Sales （unit : ¥billion） 18 ¾Status in first half 2014 16 15.3 ■ Sales ： ¥8bln (actual ＋¥2.5bln、＋46.7%） 14 13 2 13.2 ・expand of stragetic products and supplementary Item launched in 12.4 FY12,FY13 12 2nd 10.3 10.4 7.3 ・increase of contract manufacturing
Slide 17: Status of development pipeline
St t off development Status d l t pipeline i li 16
Slide 18: Drug Development Pipeline: Progress in FY2014
Drug Development Pipeline: Progress in FY2014 Approval/ pp Product & development code PhⅠ PhⅡ PhⅢ application Launch launch Nov/13 56 inhalations Fultiform launch 120 inhalations Respiratory KRP-AB1102 approval KRP-AB1102F PhⅢ Clinical trial U l i l Urological KRP 114V KRP-114V to be prepared Otolar
Slide 19: COPD treatment agent: KRP-AB1102
COPD treatment agent : KRP-AB1102 ■KRP-AB1102 ■KRP-AB1102F Action ： Long-acting muscarine M3 antagonist (LAMA) Fixed dose combination of LAMA and di t ： Aclidinium A ti iingredient Active A lidi i B Bromide id LABA (Long Acting Muscarinic Antagonist) Formulation ： Dry Powder Inhaler Target disease ：
Slide 20: Therapeutic agent for overactive bladder: KRP-114V
Therapeutic agent for overactive bladder : KRP-114V ■Merck has granted to Kyorin an exclusive license to develop , manufacture f t andd commercialize i li Vibegron Vib i JJapan in Action : selective beta 3 adrenergic receptoragonist activity Active ingredient : Vibegron Indicaions : The following sy
Slide 21: Tinnitus treatment agent: KRP-209
Tinnitus treatment agent : KRP-209 Phase II clinical study (double-blind study) 〔Outline of clinical study〕 ・Subjects : Patients with subjective tinnitus Sample size : Approx. 400 patients ・Endpoints: THI-12* etc. (changes from baseline at each assessment time point) ※ THI : Tinnitus handicap inven
Slide 22: Gene-Therapy Product Ad-SGE-REIC
Gene-Therapy Product「Ad-SGE-REIC※１」 Taking on challenges for new drug discovery technology Target disease : Malignant Pleural Mesothelioma (number of deaths : 1,400 in 2012) Features : It is expected to have direct effect on primary tumor lesions and indirect effect on metastatic tumor lesions as a
Slide 23: Reinforce New Drug Business (pipeline)
Reinforce New Drug Business(pipeline) Respiratory Otolaryngological Urological IBD 【 COPD treatment agent 】 【Tinnitus treatment agent 】 【Overactive bladder 】 【Crohn disease】 KRP-AB1102 KRP-209 KRP-114V KRP-203 KRP-AB1102F 【quinolone antibacterial agent 】 KRP-AM1977X、KRP-AM1977Y 【gene therapy】 Ad-SGE
Slide 24: Consolidated Financial Results Forecast for the Year Ending March 31 2015 and Dividends
Consolidated Financial Results Forecast f th for the Year Y Ending E di March M h 31 2015 and d Dividends 23
Slide 25: Consolidated Financial Results Forecast for the Year Ending March 31, 2015
Consolidated Financial Results Forecast for the Year Ending March 31, 2015 （unit : ¥billion） Mar/15 Change Mar/14 Change % Change from original Revised forecast forecast 111.4 111.7 ＋0.3 ＋0.3 －0.5 Net Sales Ethical drugs business 109.7 110.0 ＋0.3 ＋0.3 －0.5 Healthcare(skincare) B i Business 17 1.7 1.
Slide 26: Forecast of Mainstay Product Sales and Generic Drugs
Forecast of Mainstay Product Sales and Generic Drugs （unit : ¥billion） Mar/15 Change Mar/14 Change % Change from original Revised forecast forecast Kipres p 40.2 40.2 0 ＋0.1 －0.1 Mucodyne 18.4 13.8 －4.6 －24.6 －2.2 Pentasa 18.6 16.7 －1.9 －9.9 －0.8 Uritos 81 8.1 75 7.5 －0 6 －0.6 －6 6 －6.6 －0 7 －0.7 Fl
Slide 27: Shareholder Returns
Shareholder Returns Basic Policy The Company p y seeks to enhance its management g base byy balancing g investments for growth and business continuity with shareholder returns. To this end, the Company aims for a consolidated payout ratio to shareholders of 30%. Net Income FY14 FY14 FY13 ( i i l for
Slide 28: About new Development Research Laboratories
about new Development Research Laboratories location ： 1848, Nogi, Nogi-machi, Shimotsuga-gun, Tochigi commencement of construction ： Jan / 2014 completion of construction ： Aug / 2015 commence operations ： Oct / 2015 27
Slide 29: Forward-looking statements notice
■ These forecast performance figures are based on information currently available to the Company and may include uncertain factors or risk that affect ff t our future f t performance. f Accordingly, actual business results may materially differ from the forecasted figures due to various factors in t