KYORIN Pharmaceutical Co.,Ltd. · TSE:4569

KYORIN Pharmaceutical Co.,Ltd — FY2014 Earnings Presentation

43 slides from KYORIN Pharmaceutical Co.,Ltd's earnings presentation, May 14, 2015

  1. Slide 1: Financial Results for Fiscal 2014

    Financial Results for Fiscal 2014 May 14 , 2015 g Inc. KYORIN Holdings, President Masahiro Yamashita

  2. Slide 2: Outline of Consolidated Financial Results

    „Outline of Consolidated Financial Results „Trends of mainstay products „Status of development pipeline Consolidated Financial Results Forecast and Dividends „Consolidated 1

  3. Slide 3: Outline of Consolidated Financial Results

    O tli off Consolidated Outline C lid t d Fi Financial i l Results R lt 2

  4. Slide 4: Outline of Consolidated Financial Results for Fiscal 2014

    Outline of Consolidated Financial Results for Fiscal 2014 （unit : ¥billion） Change FY2013 FY2014 Change Change(%) (forecast) Net Sales 111.4 113.1 ＋1.7 ＋1.5 ＋1.4 Operating Income 17.6 14.7 －2.9 －16.3 ＋0.9 Ordinary O di Income 18.3 15.5 －2.8 －15.3 ＋1.2 Net Income 12 0 12.0 12 1 12.1 ＋0 1 ＋0.1 ＋0 3 ＋0

  5. Slide 5: Segment Sales

    Segment Sales （unit : ¥billion） Change FY2013 FY2014 Change Change(%) (forecast) Net Sales 111.4 113.1 ＋1.7 ＋1.5 ＋1.4 109.7 111.8 ＋2.1 ＋1.9 ＋1.8 93.5 92.1 －1.4 －1.5 ＋1.3 Ethical Sales of new ethical drugs Japan 91.7 91.1 －0.6 －0.6 ＋1.4 drugs business Overseas 18 1.8 10 1.0 0.8 －0 8 44.2 －44 2 00 0.0

  6. Slide 6: Breakdown of Gain and Loss

    Breakdown of Gain and Loss （unit : ¥billion） Change FY2013 FY2014 Change Change(%) (forecast) Net Sales 111.4 113.1 ＋1.7 ＋1.5 ＋1.4 Cost of Sales 43.0 46.6 ＋3.6 ＋8.2 － SG&A 50 7 50.7 51 8 51.8 ＋1 1 ＋1.1 ＋2 1 ＋2.1 － R&D expenses 11.4 13.5 ＋2.1 ＋19.0 －0.1 SG&A expenses 39.4 38.3 －1.1 －2.8 － Operating I

  7. Slide 7: Highlights of Business Performance

    Highlights of Business Performance （ Units: ¥ billion ） ¾Net Sales increased ¥1.7billion ¥1 7billion year on year. year ・increase of Flutiform,Kipres sales ・decrease of long listed drgus sales Cost of Sales Cost of Sales ・increase of generic drugs sales 43.0 46.6 ¾Cost of Sales increased ¥3.6 billio

  8. Slide 8: Mainstay Product Sales

    Mainstay Product Sales （unit : ¥billion） Change FY2013 FY2014 Change Change(%) (forecast) Kipres 40.2 41.2 ＋1.0 ＋2.7 ＋1.0 Flutiform 06 0.6 36 3.6 ＋3 0 ＋3.0 ＋518.9 0.3 －0 3 Uritos 8.1 7.3 －0.8 －9.5 －0.2 Mucodyne 18.4 14.0 －4.4 －23.7 ＋0.2 Pentasa 18.6 17.2 －1.4 －7.4 ＋0.5 7

  9. Slide 9: Trends of mainstay products

    Trends of mainstay y products 8

  10. Slide 10: Kipres

    ■New drugs group Kipres 【Bronchial asthma and allergic rhinitis treatment】 （unit : ¥billion） „status of FY2014 zLT antagonists market ： shrink 1% ¥127.4bln（FY2013） ⇒ ¥126.2（FY2014） ※1 zshare of Kipres sales 36.0%（FY2013） ⇒ 37.6%（FY2014） ※2 „effort for FY2015 zEstablish position as base drug for trea

  11. Slide 11: Flutiform

    ■New drugs group Flutiform 【Anti-asthmatic】 （unit : ¥billion） （ ） „status of FY2014 zICS/LABA market ： expand 3.3% ¥94.1bln（FY2013） ⇒ ¥97.1（FY2014） ※1 „effort for FY2015 Further promote prescription to partly controlled zFurther asthma patients ※Even if it has taken controller, 60 to 80% of the pati

  12. Slide 12: Uritos

    ■New drugs group Uritos 【Overactive bladder】 （unit : ¥billion） „status of FY2014 zOAB market ： expand 3.6% ¥77.9bln（FY2013） ⇒ ¥80.6bln（FY2014） ※1 zshare of Uritos sales 10.2%（FY2013） ⇒ 10.2%（FY2014）※2 „effort for FY2015 zUncovering potential markets FY14 : consultation rate 30% zFurther promote pres

  13. Slide 13: Eklira Genuair

    ■New drugs group Eklira Genuair 【 COPD 】 ・ Approved on March 2015 Eklira® Genuair®｣】 【About ｢Eklira 1. Brand name :Eklira® 400μg Genuair® 30 inhalations 2.Active ingredient :Aclidinium Bromide 3.Indication :Relief from symptoms arising from respiratory tract obstruction in COPD patients ( h i bronch

  14. Slide 14: Mucodyne

    ■Original products group Mucodyne 【 Mucoregulating drug】 （unit : ¥billion） „status of FY2014 zexpectorant market ： shrink 11% ¥43.5bln（FY2013） ⇒ ¥38.8bln（FY2014） ※1 zshare of Mucodyne sales 46.2%（FY2013） ⇒ 41.4%（FY2014） ※2 share of generic (Carbocisteine) 7.4%（FY2013） ⇒ 11.7%（FY2014） ※3 „effort for

  15. Slide 15: Pentasa

    ■Original products group Pentasa 【 Ulcerative colitis and Crohn’s disease treatment 】 （unit : ¥billion） „status of FY2014 zmarket（Mesalazine etc.）： expand 2％ ¥37.9bln（FY2013） ⇒ ¥38.6bln（FY2014） ※1 zshare of Pentasa sales 52.7%（FY2013） ⇒ 50.1%（FY2014） ※2 share of generic 2.0%（FY2013） ⇒ 3.1%（FY2014） ※

  16. Slide 16: Status of Generic Drugs

    ■Generic drugs group Status of Generic Drugs g Sales （unit : ¥billion） „status of FY2014 zsales ：＋¥0.4bln（＋32.8%）year on year operating income ： ＋ ¥1.1bln（＋115.5%）year on year ・expand of supplementary Item ・increase of contract manufacturing sales ・improve of cost of sales ratio ff „effort ffor FY20

  17. Slide 17: Status of development pipeline

    Status of development pipeline 16

  18. Slide 18: New Pharmaceutical Discovery Research Laboratories

    establish of a new Pharmaceutical Discovery Research Laboratories ・location ： 1848, Nogi, Nogi-machi, a new organization Shimotsuga-gun, Tochigi 「 WATARASE Research Center 」 ・commencement of construction ： Jan / 2014 ・completion of construction ： May / 2015 ・commence operations ： Jul / 2015 reform a

  19. Slide 19: Drug Development Pipeline: Progress in FY2014, schedule of FY2015

    Drug Development Pipeline: Progress in FY2014, schedule of FY2015 Product & Approval/ development code PhⅠ PhⅡ PhⅢ application Launch 2013/Nov launch (56inhalations) Fultiform Dec launch (120inhalations) Respiratory Mar Approval Eklira Genuair launch KRP-AB1102F Ad SGE REIC Ad-SGE-REIC PhⅠ ／ Ⅱ KRP-A

  20. Slide 20: Antibacterial agent: KRP-AM1977X, KRP-AM1977Y

    Antibacterial agent : KRP-AM1977X , KRP-AM1977Y Features: (1) Superior ability to overcome drug-resistant gram-positive bacteria, (2) Migration to a target organ, (3) Expect a high level of safety Status of develpoment : KRP-AM1977X zClinical trials: Ph2 (completed) zClinical trials: Ph3 (started in

  21. Slide 21: Gene-Therapy Product Ad-SGE-REIC

    Gene-Therapy Product「Ad-SGE-REIC」 Features : It is expected to have direct effect on primary tumor lesions and indirect effect on metastatic tumor lesions as a gene-therapy drug that simultaneously induces tumor cell- selective apoptosis and the activation of antitumor immunity immunity. Ad-SGE-REIC

  22. Slide 22: Consolidated Financial Results Forecast and Dividends

    Consolidated Financial Results Forecast and Dividends 21

  23. Slide 23: Consolidated Financial Results Forecast for the Year Ending March 31, 2016

    Consolidated Financial Results Forecast for the Year Ending March 31, 2016 （unit : ¥billion） FY2014 FY2015 forecast Change Change(%) 113.1 120.2 ＋7.1 ＋6.3 Net Sales Ethical drugs business 111.8 118.6 ＋6.8 ＋6.1 Healthcare(skincare) ( ) Business 13 1.3 16 1.6 ＋0 3 ＋0.3 ＋25 5 ＋25.5 Operating Income 14.

  24. Slide 24: Forecast of Mainstay Product Sales

    Forecast of Mainstay Product Sales （unit : ¥billion） FY2015 FY2014 Forecast Change Change(%) Kipres 41.2 41.8 ＋0.6 ＋1.5 Flutiform 36 3.6 10 3 10.3 ＋6 7 ＋6.7 ＋185 4 ＋185.4 Uritos 7.3 7.9 ＋0.6 ＋9.4 Mucodyne 14.0 11.8 －2.2 －15.6 Pentasa 17.2 17.1 －0.1 －0.3 23

  25. Slide 25: Progress of Medium-Term Business Plan HOPE 100 Stage 1

    progress of Medium-Term Business Plan "HOPE 100 －Stage 1 －" Medium-Term Business Plan "HOPE 100 －Stage 1 －" FY10～FY15 140.0 Sales Health care business （ Units: ¥ billion ） ・delay of developing a business 120.2 111.4 113.1 104 1 104.1 107.0 Generic drugs g group g p 103 2 103.2 99.8 ・progress of Cont

  26. Slide 26: Shareholder Returns Basic Policy

    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 FY2014 FY2015 FY2014 (fore

  27. Slide 27: Reference

    Kyorin ©) @Rld+a-VLORUTT. Reference 26

  28. Slide 28: P&L Summary: Consolidated Results – (1)

    P&L Summary: Consolidated Results – (1) （ Units: ¥ million ） ＜ Breakdown ＞ change FY2013 FY2014 ■Sales ¥ 113,121 （＋¥1,721） Actual % Sales Actual % Sales % Change Change ●Ethical drug sales in Japan Sales 111,400 100.0% 113,121 100.0% ＋1.5 ＋1,721 ¥91,079 （－ ¥589） ■Ethical Drugs FY13 FY14 （¥:billion）

  29. Slide 29: P&L Summary: Consolidated Results – (2)

    P&L Summary: Consolidated Results – (2) （ Units: ¥ million ） FY2013 FY2014 ＜ Breakdown ＞ ◆Cost of Sales Ratio : +2.6 percentage points Actual % Sales Actual % Sales % Change Change (38.6 ％→41.2％) Sales 111,400 100.0% 113,121 100.0% ＋1.5% ＋1,721 ・Drug price revisions (in the 6%range for KYORIN Pharma

  30. Slide 30: BS Summary: Consolidated Results

    BS Summary: Consolidated Results FY2013 FY2014 （ Units: ¥ million ） Actual %total Actual % total change ＜ Breakdown ＞ Current Assets 121,638 71.8% 129,064 70.4% ＋7,426 ■ Current Asset ： ＋7,426 Cash, deposits 31,017 30,652 ・ Cash, deposits （ －365） Notes and accounts receivable 44,123 47,007 Mk securi

  31. Slide 31: Financial summary (Consolidated)

    Financial summary (Consolidated) FY2015 （¥ million） FY2010 FY2011 FY2012 FY2013 FY2014 (forecast) Sales 104,069 103,232 107,031 111,400 113,121 120,200 (Exports) (2 784) (2,784) (2 015) (2,015) (2 400) (2,400) (1 849) (1,849) (1 032) (1,032) (1 000) (1,000) Cost of Sales 37,554 36,926 40,133 43,047

  32. Slide 32: Segment information

    Segment information Sales, Profit or Loss of each report segment （ Units: ¥ billion ） S l Sales change h P fit Profit Ch Change Net Sales (total) 113.1 ＋1.7 14.7 －2.9 Ethical drugs dr gs business b siness 111 8 111.8 ＋2 1 ＋2.1 14 6 14.6 24 －2.4 ◆Sales of new ethical drugs 92.1 －1.4 ○Japan 91.1 91 1

  33. Slide 33: P&L summary: KYORIN Pharmaceutical (Non-consolidated)-(1)

    P&L summary : KYORIN pharmaceutical (Non-consolidated)-(1) （ Units: ¥ million ） ＜ Breakdown ＞ change FY2013 FY2014 ■Sales ¥ 98,452 （ ＋¥790） % ●Ethical drug sales in Japan Actual % Sales Actual % Sales Change Change ¥88,012 （－ ¥184） FY13 FY14 （¥:billion） Sales 97,662 100.0% 98,452 100.0% ＋0.8% ＋790 ・

  34. Slide 34: P&L summary: KYORIN Pharmaceutical (Non-consolidated)-(2)

    P&L summary : KYORIN pharmaceutical (Non-consolidated)-(2) （ Units: ¥ million ） ＜ Breakdown ＞ FY2013 FY2014 % ◆ Cost of Sales Ratio ： ＋3.6percentage points Actual % Sales Actual % Sales Change Change (36.0％→39.6％) Sales 97,662 100.0% 98,452 100.0% ＋0.8% ＋790 ・Drug price revisions (in the 6%range for

  35. Slide 35: BS Summary: KYORIN Pharmaceutical (Non-consolidated)

    BS Summary: KYORIN Pharmaceutical (Non-consolidated) （ Units: ¥ million ） FY2013 FY2013 Actual % total Actual % total change ＜ Breakdown ＞ Current Assets 92,209 70.4% 97,822 68.4% ＋5,613 Cash, deposits 15,098 14,587 ■ Current Assets ： ＋5,613 Accounts receivable 40,133 43,220 ・ Cash, deposits （ －511）

  36. Slide 36: Financial Summary: KYORIN Pharmaceutical (Non-consolidated)

    Financial Summary: KYORIN Pharmaceutical (Non-consolidated) FY2015 （¥ million） FY2010 FY2011 FY2012 FY2013 FY2014 (forecast) Sales 92,531 93,697 95,894 97,662 98,452 105,300 (Exports) (2,642) (2 642) (1,904) (1 904) (2,277) (2 277) (1,650) (1 650) (840) (700) Cost of Sales 31,227 32,046 33,868 35,11

  37. Slide 37: Consolidated Financial Results and full year forecast

    Consolidated Financial Results and full year forecast （ Units: ¥ million ） FY2015 Year on year FY2013 FY2014 ((forecast)) change change（%） Sales 111,400 113,121 120,200 ＋7,079 ＋6.3 ■Ethical Drugs business 109,678 , 111,771 , 8,600 118,600 , ＋6,829 ＋6.1 ◆Sales of new Ethical Drugs 93,518 92,111 95,70

  38. Slide 38: Main Subsidiary Companies

    Main Subsidiary Companies （ Units: ¥ billion ） KYORIN pharmaceutical FY2013 FY2014 FY2015(forecast) Sales 97 7 97.7 98 5 98.5 105 3 105.3 Operating Income 15.4 12.2 13.3 Net Income 10 8 10.8 10 4 10.4 10 0 10.0 KYORIN Rimedio FY2013 FY2014 FY2015(forecast) Sales 12.4 16.4 18.5 Operating Income 1.0 2

  39. Slide 39: Main Product Sales Update

    Main Product Sales Update （ Units: ¥ billion ） FY2014 FY2015 FY2010 FY2011 FY2012 FY2013 actual C Change(%) (%) (f (forecast) t) Kipres （LT receptor antagonist） 34.5 36.8 39.6 40.2 41.2 ＋2.7 41.8 Mucodyne （Mucoregulant） 21 3 21.3 21 5 21.5 19 1 19.1 18 4 18.4 14 0 14.0 23 7 －23.7 11 8 11.8 Pentasa S

  40. Slide 40: R&D Expenses, Capex & Depreciation

    R&D Expenses, Capex & Depreciation （ Units: ¥ million ） FY2014 FY2015 FY2010 FY2011 FY2012 FY2013 actual change （forecast） R&D expenses 12,495 13,964 11,059 11,359 13,514 ＋19.0% 13,400 Capital expenditure 1 668 1,668 1 952 1,952 6 576 6,576 6 500 6,500 2 655 2,655 59 2% －59.2% 8 700 8,700 Depreciati

  41. Slide 41: Main R&D Activities -1 (May 13, 2015 Release)

    Main R&D Activities -1 (May 13, 2015 Release) Ph III ~ Application submitted ※Changes from the previous announcement(Feb 2 2015) Stage Compound/ Therapy py area/Action Origin g Features Comments C d Code Japan Overseas ※Approval (Europe) KRP-AB1102 Chronic Obstructive Almirall - New Chemical Entity:

  42. Slide 42: Main R&D Activities -2 (May 13, 2015 Release)

    Main R&D Activities -2 (May 13, 2015 Release) POC Project (Ph I ~ Ph II) ※Changes from the previous announcement(Feb 2 2015) Stage Compound/ Therapy area/Action Origin Features Comments Code Japan Overseas PhⅡ PhⅢ KRP-209 Tinnitus Merz KRP-209 (Neramexane) is expected to improve License agreement wi

  43. Slide 43: Forecast performance figures cautionary note

    ■ 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

Kyorin Holdings — FY2014 Earnings Presentation on 6ix