Kyorin Pharmaceutical Co.,ltd. · TSE:4569
Kyorin Pharmaceutical Co.,ltd — H1 FY2018 Earnings Presentation
30 slides from Kyorin Pharmaceutical Co.,ltd's earnings presentation, Nov 6, 2018
Slide 1: Interim Term Financial Results Ended September 2018
Interim Term Financial Results Ended September 2018 November 6 , 2018 g Inc. KYORIN Holdings, President Minoru Hogawa
Slide 2: Outline of Consolidated Financial Results
Outline of Consolidated Financial Results ・Trends of mainstay products Consolidated Financial Results and Forecast Status of Development Pipeline Basic Policy and initiatives related to capital policy 1
Slide 3: Outline of Consolidated Financial Results
O tli off Consolidated Outline C lid t d Financial Fi i l Results R lt 2
Slide 4: Outline of Consolidated Financial Results for the Interim Term Ended September 2018
Outline of Consolidated Financial Results for the Interim Term Ended September 2018 Change （ it : ¥billi （unit ¥billion）） S /17 Sep/17 S /18 Sep/18 Change Change(%) (forecast) Announced on May 10, 2018 N tS Net Sales l 50 8 50.8 50 4 50.4 －0.4 04 －0.8 08 ＋0.2 02 Operating Income 1.4 29 2.9 ＋1.5 ＋97.
Slide 5: Segment Sales and Breakdown of Gain and Loss
Segment Sales and Breakdown of Gain and Loss Change Change （unit : ¥billion） Sep/17 Sep/18 Change (%) (forecast) Announced on May 10, 2018 Net Sales 50.8 50.4 －0.4 －0.8 ＋0.2 48.0 47.6 －0.4 －0.8 ＋0.2 Sales of 35.0 34.0 －1.0 －2.7 －0.1 new Ethical drugs ethical Japan 34.4 33.4 －1.0 －3.0 －0.2 business d
Slide 6: Highlights of Business Performance: Net sales
Highlights of Business Performance:①Net sales （Units: ¥billion） 【 Net Sales ￥－0.4bin 】 Healthcare Business￥±0 60 ・Growth of RUBYSTA and Milton 50.8 50.4 50 28 2.8 28 2.8 【 Ethical drugs business－0.4】 13.0 Generic drugs ￥＋0.6bin 40 13.6 I ・Increase off MONTELKAST AG sales l 0.5 0.6 ・ Launches of new
Slide 7: Highlights of Business Performance: Operating Income
Highlights of Business Performance : ②Operating Income （Units: ¥billion） 3 2.9 【 Operating Income＋￥1.5bin 】 －0.3 03 2.5 Gross Profit decreased Net Sales decreased ¥0.4billion year on year. Cost of sales ratio increased １.６%. 2 ・ Drug price revisions ・Increase of sales of Generic drugs 1.5 14 1.4 －2.
Slide 8: Highlights of Business Performance: Change (forecast)
Highlights of Business Performance ：③Change (forecast) Change Change (forecast) （unit : ¥billion） Sep/17 Sep/18 Change (%) Announced on May 10, 2018 Net Sales 50.8 50.4 －0.4 －0.8 ＋0.2 48.0 47.6 －0.4 －0.8 ＋0.2 35.0 34.0 －1.0 －2.7 －0.1 Ethical drugs Sales of new ethical drugs Japan 34.4 33.4 －1.0 －3.0
Slide 9: Main Product Sales Update
Main Product Sales Update Change （unit : ¥billion） Sep/17 Sep/18 Change Change(%) (forecast) Announced on Mayy 10,, 2018 Flutiform (Combination drug for asthma treatment) 5.4 6.1 ＋0.7 ＋12.4 ＋0.4 Uritos（Kyorin） (O (Overactive ti bl bladder) dd ) 3.6 3.5 －0.1 －3.7 ＋0.1 Desalex (Antiallergic Agent) 0.9
Slide 10: Trends of mainstay products and Generic drugs
Trends of mainstay products and Generic drugs 9
Slide 11: Respiratory/Otolaryngology: Flutiform
■Respiratory/Otolaryngology Flutiform 【Anti-asthmatic】 （ Units: ¥ billion ） 12.3 11.9 ■ Status in first half 2018 12 10.1 ICS/LABA market ： expand 2.7% ¥55.2bln（FY17 first half） ⇒ ¥56.7bln（FY18 first half） ※1 10 6.6 2nd share of Flutiform sales 6.5 half 11.0%（FY17 first half ） ⇒ 11.9％（FY18 first h
Slide 12: Respiratory/Otolaryngology: Desalex and Nasonex
■Respiratory/Otolaryngology （ Units: ¥ billion ） Desalex(Antiallergic Agent) 8.1 Nasonex Spray type allergic rhinitis remedy） （ 8 ■ Acquire domestic exclusive 6 2nd distribution rights (May.2018) 4.9 half 5.1 4 ■August 2018 sales start 4.0 【Sales Results】 1.3 billion yen 2 1st (Fiscal year ending Se
Slide 13: Respiratory/Otolaryngology: Kipres
■Respiratory/Otolaryngology Kipres 【Bronchial asthma and allergic rhinitis treatment】 （ Units: ¥ billion ） 28 7 28.7 30 26.7 25 20 16.3 17.7 Adult 15.3 15 62 6.2 10 8.3 6.0 2nd 5 11.4 12.4 11.5 4.4 half 31 3.9 2.9 2.9 1st 0 19/3 half ■ Status in first half 2018 15/3 16/3 17/3 18/3 18/9 forecast LT
Slide 14: Urology: Uritos
■Urology （ Units: ¥ billion ） OAB market （ Units: ¥ billion ） Uritos（Overactive bladder) 87 90 91 81 8 8 7.3 7.5 7.5 77 72 7.2 β3 receptor 6.8 agonist 6 others 3.8 3.7 3.6 2nd 3.9 3.4 half 4 anticholiner gic agent 2 3.7 3.8 3.6 3.5 1st 3.4 3.4 half 0 出典：Copyright © 2018 IQVIA. IMS-JPM 2013/3-2018/3を
Slide 15: Status of Generic Drugs
■Status of Generic Drugs Kei ■Generic drugs Sales 27.7 （unit : ¥billion） 27.4 25.0 25 20 14.7 14.2 2nd 14.7 15.5 15.5 half 15 7.7 8.1 ■ Status in first half 2018 10 1st 13.6 13.2 half MONTELUKAST AG increase ￥5.3bin(＋￥0.3bln) 13.0 5 10.3 【 price rivision rate ▲18.0%】 7.8 7.4 2018 June supplementar
Slide 16: Consolidated Financial Results and Forecast
Consolidated Financial Results and Forecast 15
Slide 17: Consolidated Financial Results Forecast for the Year Ending March 31, 2019
Consolidated Financial Results Forecast for the Year Ending March 31, 2019 （ Units: ¥ billion ） FY2018 Y/Y FY2017 （forecast） Change Change(%) Net sales 110.6 114.4 ＋3.8 +3.4 104.7 108.4 ＋3.7 ＋3.5 77 0 77.0 80 9 80.9 ＋3.9 39 ＋5.0 50 Sales of Ethical drugs new ethical Japan 73.7 79.9 ＋6.2 ＋8.4 busines
Slide 18: Forecast of Mainstay Product Sales
Forecast of Mainstay Product Sales （ Units: ¥ billion ） Y/Y FY2018 FY2017 （forecast） Change g Change(%) g ( ) Flutiform (Combination drug for asthma treatment) 11.9 12.3 ＋0.4 ＋4.1 Uritos（Kyorin） (Overactive bladder) 72 7.2 68 6.8 －0.4 0.4 －4.7 4.7 Desalex (Antiallergic Agent) 4.9 8.1 ＋3.2 ＋65.3 Kipr
Slide 19: Status of development pipeline
St t off development Status d l t pipeline i li 18
Slide 20: Drug Development Pipeline: Progress in FY2017, schedule of FY2018
Drug Developmet Pipeline: Progress in FY2017, schedule of FY2018 schedule of FY18 development code PhⅠ PhⅡ PhⅢ application Approval/ Launch E d off the End th PhⅠ／PhⅡ Ad-SGE-REIC PhⅡ start Respiratory KRP-108P 2017/6 FY19 Expected KRP-AM1977X 2017/4 Release Infections KRP-AM1977Y preparation p p FY1
Slide 21: Drug Development Pipeline: Progress in FY2017, schedule of FY2018
Drug Developmet Pipeline: Progress in FY2017, schedule of FY2018 schedule of FY18 progress in FY18 2Q ※ Changes from the previous announcement(July 31 2018) development code PhⅠ PhⅡ PhⅢ application approval Launch End of the PhⅠ／PhⅡ Ad-SGE-REIC ※ 2018/6 PhⅡ start Respirat ory KRP-108P 2017/6 FY19 KR
Slide 22: Beova Tablets 50 mg
Beova Tablets 50 mg (selective β3-adrenergic receptor agonist for the treatment of overactive bladder) Generic name: Vibegron Development status ■Approval obtained: September 21 21, 2018 ■ To be listed in the NHI drug price list in November ◆ Co-developed and co-marketed with Kissei Pharmaceutical
Slide 23: Beova Tablets 50 mg
Beova Tablets 50 mg (selective β3-adrenergic receptor agonist for the treatment of overactive bladder) Phase III clinical study results: [Secondary endpoints] Data available at time of approval (domestic phase III controlled study) Average voided volume Average number of urgency Average number of Av
Slide 24: Expansion of Market Share for Treatments of Overactive Bladder (OAB)
Expansion of Market Share for Treatments of ウリトス/ビベグロン Overactive Bladder (OAB)訴求ポイント Market for Treatments of Overactive Bladder (OAB) β３receptor Antichorinergic agonist Uritos Beova ・Excellent effectiveness against nocturia ・Subtle dosage adjustments possible Excellent efficacy ・Effective against
Slide 25: KRP-N118, Therapeutic Agent for Nocturia
KRP-N118, Therapeutic Agent for Nocturia Development Status Phase II clinical study （initiated in August 2018） Study: Randomized, double-blind, placebo-controlled study Name of disease: Nocturia due to nocturnal polyuria [Primary endpoint] Nocturnal urinary frequency Overview of KRP-N118 ■Mechanism
Slide 26: Basic Policy and initiatives related to capital policy
Basic Policy y and initiatives related to capital policy 25
Slide 27: Shareholder Returns
Shareholder Returns Basic Policy(After the change) ・While Whil maintaining i t i i the th sound d financial fi i l base, b we aimi tto improve i the th capital it l efficiency through growth investment and returns to shareholders. ・We will maintain stable dividends taking DOE (Dividend on Equity rat
Slide 28: Acquisition of Treasury Stock
Acquisition of Treasury Stock Completion of Acquisition of Treasury Stock through Off-Floor Trading for Purchase of Treasury Stock (ToSTNeT-3) Reason ffor acquisition R i iti off treasury t stock t k ◆To improve the capital efficiency and implement a flexible and agile capital policy in accordance w
Slide 29: Borrowing of Funds Associated with the Acquisition of Treasury Stock and Future Policy
Borrowing of Funds Associated with the Acquisition of Treasury Stock and Future Policy ■ Funds F d for f the h acquisition i i i off treasury stock k ・Short-term loan Around 40.0 billion yen ■ Future policy ・Repayment (sales of bond, etc.）by funds on hand ・Around Around 20.0 20 0 billion yen is stil
Slide 30: Notice Regarding the Cancellation of Treasury Stock
Notice Regarding the Cancellation of Treasury Stock The Board of Directors of KYORIN Holdings, Inc., (" KYORIN ") at its meeting held today today, resolved that KYORIN will cancel a portion of its treasury stock pursuant to Article 178 of the Companies Act of Japan, as stated below. T Type off sha