KYORIN Pharmaceutical Co.,Ltd. · TSE:4569

KYORIN Pharmaceutical Co.,Ltd — H1 FY2015 Earnings Presentation

45 slides from KYORIN Pharmaceutical Co.,Ltd's earnings presentation, Nov 6, 2015

  1. Slide 1: Interim Term Financial Results Ended September 2015

    Interim Term Financial Results Ended September 2015 November 6 , 2015 KYORIN Holdings, Inc. President Minoru Hogawa

  2. Slide 2: Outline of Consolidated Financial Results; agenda

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

  3. Slide 3: Outline of Consolidated Financial Results

    Outline of Consolidated Financial Results 2

  4. Slide 4: Outline of Consolidated Financial Results for the Interim Term Ended September 2015

    Outline of Consolidated Financial Results for the Interim Term Ended September 2015 （unit : ¥billion） Change Mar/15 Mar/16 Sep/14 Sep/15 Change Change(%) (forecast) (forecast) Net Sales 51.1 52.4 ＋1.3 ＋2.5 －2.0 113.1 120.2 Operating 4.6 4.1 －0.5 －10.6 ＋0.3 14.7 16.0 Income Ordinary 4.9 4.3 －0.6 －12.

  5. Slide 5: Segment Sales

    Segment Sales （unit : ¥billion） Change Sep/14 Sep/15 Change Change(%) (forecast) Net Sales 51.1 52.4 ＋1.3 ＋2.5 －2.0 50.5 51.8 ＋1.3 ＋2.5 －1.9 40.8 42.2 ＋1.4 ＋3.6 －0.7 Sales of new Ethical drugs ethical drugs Japan 40.4 41.6 ＋1.2 ＋3.0 －0.9 business Overseas 0.3 0.6 ＋0.3 ＋78.7 ＋0.2 Generic drugs 7.8 7.

  6. Slide 6: Highlights of Business Performance

    Highlights of Business Performance （Units: ¥billion） Net Sales increased ¥1.3billion year Cost of Sales on year. Cost of Sales ・increase of main prodicts 21.3 21.6 (Flutiform,Mucodyne,Uritos) Cost of Sales Ratio Cost of sales ratio decreased 0.6%. Cost of Sales Ratio ・Sales of main product increas

  7. Slide 7: Breakdown of Gain and Loss

    Breakdown of Gain and Loss （unit : ¥billion） Change Sep/14 Sep/15 Change Change(%) (forecast) Net Sales 51.1 52.4 ＋13 ＋2.5 －2.0 Cost of Sales 21.3 21.6 ＋3 ＋1.0 － SG&A 25.2 26.7 ＋15 ＋6.1 － R&D expenses 6.7 7.3 ＋6 ＋8.9 －0.1 SG&A expenses 18.5 19.5 ＋10 ＋5.1 － Operating Income 4.6 4.1 －5 －10.6 ＋0.3 Ordi

  8. Slide 8: Mainstay Product Sales

    Mainstay Product Sales （unit : ¥billion） Change Sep/14 Sep/15 Change Change(%) (forecast) Kipres 17.4 18.8 ＋1.4 ＋7.9 ＋0.7 Flutiform 0.9 3.0 ＋2.1 ＋216.2 －1.1 Uritos 3.4 3.7 ＋0.3 ＋9.3 －0.1 Mucodyne 6.2 5.9 －0.3 －3.6 ＋0.7 Pentasa 8.6 8.1 －0.5 －5.9 －0.3 Generic drugs 7.8 7.4 －0.4 －5.1 －1.3 7

  9. Slide 9: Trends of mainstay products

    Trends of mainstay products 8

  10. Slide 10: New drugs group: Kipres

    ■New drugs group Kipres 【Bronchial asthma and allergic rhinitis treatment】 Sales （unit : ¥billion） 41.2 41.8 ■status in first half 2015 39.6 40.2 LT antagonists market ： expand 5% 36.8 ¥56.2bln（FY14 first half） ⇒ ¥58.8bln（FY15 first half） ※1 34.5 share of Kipres sales 37.2%（FY14 first half ） ⇒ 38.

  11. Slide 11: New drugs group: Flutiform

    ■New drugs group Flutiform 【Anti-asthmatic】 Sales （unit : ¥billion） 10.3 ■ Status in first half 2015 ICS/LABA market ： expand 17% ¥43.8bln（FY14 first half） ⇒ ¥51.4bln（FY15 first half） ※1 share of Flutiform sales 7%（September 2015） ※2 2nd half ■ effort for FY2015 Further promote prescription to pa

  12. Slide 12: Pentasa

    ■Original products group Pentasa 【 Ulcerative colitis and Crohn’s disease treatment 】 Sales （unit : ¥billion） 19.4 18.0 18.6 17.6 ■ status in first half 2015 17.2 17.1 market（Mesalazine etc.）： expand 4％ ・¥18.9bln（FY14 first half ） ⇒ ¥19.6bln（FY15 first half ） ※1 share of Pentasa sales 51.6%（FY14 f

  13. Slide 13: Generic drugs

    ■Generic drugs Sales （unit : ¥billion） 18.2 ■Status in first half 2015 15.5 Sales of Health insurance pharmacy market’s decreased compared to forecast ・Supplementary Item and main products etc. 2nd half 12.0 Sales of Contract manufacturing decreased compared to forecast 10.1 8.9 8.7 ■effort for FY

  14. Slide 14: Consolidated Financial Results Forecast and Dividends

    Consolidated Financial Results Forecast and Dividends 13

  15. Slide 15: 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 1.3 1.6 ＋0.3 ＋25.5 Operating Income 14.7 16.0 ＋1.3 ＋8.6 Ordi

  16. Slide 16: 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 3.6 10.3 ＋6.7 ＋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 Generic drugs 15.5 18.2 ＋2.7 ＋17.6 ※The results forecasts for the

  17. Slide 17: Shareholder Returns

    Shareholder Returns Basic Policy The Company seeks to enhance its management base by balancing 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 FY15 (forecast) Net Income ¥12

  18. Slide 18: Status of development pipeline

    Status of development pipeline 17

  19. Slide 19: Drug Development Pipeline: schedule of FY2015

    Drug Development Pipeline : schedule of FY2015 Product & Approval/ PhⅠ PhⅡ PhⅢ application Launch development code Eklira Genuair launch Respiratory KRP-AB1102F Ad-SGE-REIC PhⅠ／PhⅡ KRP-AM1977X 15/4 PhⅢ Infections KRP-AM1977Y Otolaryngolo KRP-209 PhⅡ gical （ Desloratadine Co-Marketing Agreement for J

  20. Slide 20: Drug Development Pipeline: Progress in FY2015

    Drug Development Pipeline : Progress in FY2015 Product & Approval/ PhⅠ PhⅡ PhⅢ application Launch development code Eklira Genuair 15/5 launch Respiratory KRP-AB1102F Ad-SGE-REIC 15/7 PhⅠ／PhⅡ Kipres OD 15/8 approval KRP-AM1977X 15/4 PhⅢ Infections KRP-AM1977Y Otolaryngolo KRP-209 15/8 PhⅡ gical （ Des

  21. Slide 21: KRP-203

    KRP-203  Mode of action : Sphingosine-1-Phosphate Receptor Agonist  Business partner : Novartis (License agreement executed on February 2006) Based on the data in the various clinical trials conducted worldwide, the competing products and the priorities in our pipeline, we decided to focus on the

  22. Slide 22: Antiallergic Agent Desloratadine

    Antiallergic Agent「 Desloratadine」 Co-Marketing Agreement for Japan with MSD K.K. affiliate(November 2014) MSD Submits New Drug Application(October 2015) 【 Details of application】 【 Antihistamine market】 （unit : ¥billion） 2500 250 Features： second generation histamine H1-receptor antagonist Compou

  23. Slide 23: Antibacterial agent KRP-AM1977X, KRP-AM1977Y

    Antibacterial agent : KRP-AM1977X , KRP-AM1977Y International Nonproprietary Name ： lascufloxacin （r-INN） 【 Features 】 ・Have a broad antibacterial spectrum from Gram-positive bacteria to Gram-negative bacteria and atypical bacteria. Also have stronger antibacterial activity to anaerobic bacteria th

  24. Slide 24: 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. Ad-SGE- REIC used in

  25. Slide 25: Macrocyclic/Constrained Peptides Drug Discovery

    Macrocyclic/Constrained Peptides Drug Discovery [November 2015] Peptide Discovery Collaboration Agreement with PeptiDream Inc. Collaboration by using PDPS* technology to generate macrocyclic/constrained peptides against target protein. [Summary] ・Use PeptiDream’s proprietary PDPS technology, which w

  26. Slide 26: Aim to become a manufacturer of original new drugs

    about our future drug discovery Aim to become a manufacture of original new drugs that can contribute to the health of the world’s people. 【a new Pharmaceutical Discovery Research Laboratories】 WATARASE Research Center History of KYORIN Pharmaceutical’s drug discovery KRP-203 Gatifloxacin Licensed t

  27. Slide 27: Reference

    Kyorin ©) BRERES—UYORUTT. Reference 26

  28. Slide 28: New drugs group: Uritos

    ■New drugs group Uritos 【Overactive bladder】 Sales （unit : ¥billion） ■ Status in first half 2015 8.1 7.9 OAB market ： expand 13% ¥37.8bln （FY14 first half） ⇒ ¥42.6bln （FY15 first half）※1 7.5 7.3 share of Uritos sales 10.3% （FY14 first half） ⇒ 9.6% （FY15 first half） ※2 6.3 2nd half 5.5 ■ effort for

  29. Slide 29: Original products group: Mucodyne

    ■Original products group Mucodyne 【 Mucoregulating drug】 Sales （unit : ¥billion） ■Status in first half 2015 21.3 21.5 expectorant market： expand 2% 19.1 18.4 ¥17.7bln（FY14 first half） ⇒ ¥18.0bln（FY15 first half） ※1 share of Mucodyne sales in expectorant market 41.3%（FY14 first half ） ⇒ 37.8% （FY15

  30. Slide 30: P&L Summary: Consolidated Results (1)

    P&L Summary: Consolidated Results – (1) （unit : ¥million） ＜ Breakdown ＞ Sep/2014 Sep/2015 Year on Year Actual % Sales Actual % Sales % Change Change ■ Sales ¥52,386mil （＋¥1,274mil） Sales 51,112 100.0% 52,386 100.0% ＋2.5% ＋1,274 ● Ethical drug sales in Japan ■Ethical Drugs ¥41,634mil （＋¥1,211mil） 50,

  31. Slide 31: P&L Summary: Consolidated Results (2)

    P&L Summary: Consolidated Results – (2) （unit : ¥million） Sep/2014 Sep/2015 ＜ Breakdown ＞ ◆Cost of Sales Ratio : Actual % Sales Actual % Sales % Change Change down 0.6 percentage points Y/Y (41.8％→41.2％) Sales 51,112 100.0% 52,386 100.0% ＋2.5% ＋1,274 ・Sales of main product increased ・Sales of generi

  32. Slide 32: BS Summary: Consolidated Results

    BS Summary: Consolidated Results Mar/2015 Sep/2015 （ Units: ¥ million ） Actual %total Actual % total change ＜ Breakdown ＞ Current Assets 129,064 70.4% 124,080 －4,984 66.1% ■ Current Asset ： －4,984 30,652 45,043 ・ Cash, deposits （＋14,390） Cash, deposits Notes and accounts receivable 47,007 38,609 ・ N

  33. Slide 33: Financial summary (Consolidated)

    Financial summary (Consolidated) （unit : ¥million） Mar/2015 Mar/2016 Sep/2013 Sep/2014 Sep/2015 (forecast) Sales 50,851 51,112 52,386 113,121 120,200 (Exports) (1,160) (332) (594) (1,032) (1,000) Cost of Sales 19,097 21,340 21,561 46,598 ― (cost of Sales Ratio )(%) (37.6%) (41.8%) (41.2%) (41.2%) SG

  34. Slide 34: Segment information for the Second Quarter Ended Sep 30, 2015

    Segment information for the Second Quarter Ended Sep 30, 2015 Sales, Profit or Loss of each report segment Sales change Y/Y Profit change Y/Y Net Sales (total) 52.4 ＋1.3 4.1 －0.5 Ethical drugs business 51.8 ＋1.3 4.0 －0.5 ◆Sales of new ethical drugs 42.2 ＋1.4 ○Japan 41.6 ＋1.2 ○Overseas 0.6 ＋0.3 ◆Gene

  35. Slide 35: P&L summary: KYORIN Pharmaceutical (Non-consolidated) (1)

    P&L summary : KYORIN pharmaceutical (Non-consolidated)-(1) （unit : ¥million） ＜ Breakdown ＞ Year on Year Sep/2014 Sep/2015 ■ Sales ¥46,157mil （＋¥2,234mil） ● Ethical drug sales in Japan Actual % Sales Actual % Sales % Change Change ¥40,604mil （＋¥1,496mil） Sales 43,922 100.0% 46,157 100.0% ＋5.1% ＋2,234

  36. Slide 36: P&L summary: KYORIN Pharmaceutical (Non-consolidated) (2)

    P&L summary : KYORIN pharmaceutical (Non-consolidated)-(2) （unit : ¥million） ＜ Breakdown ＞ Sep/2014 Sep/2015 Actual % Sales Actual % Sales % Change Change ◆ Cost of Sales Ratio : up 0.3 percentage points Y/Y (39.5％→39.8％) Sales 43,922 100.0% 46,157 100.0% ＋5.1% ＋2,234 ◆R&D Ratio : up 0.6percentage p

  37. Slide 37: BS Summary: KYORIN Pharmaceutical (Non-consolidated)

    BS Summary: KYORIN Pharmaceutical (Non-consolidated) （unit : ¥million） Mar/2015 Sep/2015 ＜ Breakdown ＞ Actual % total Actual % total change ■ Current Assets ：－5,389mil Current Assets 97,822 68.4% 92,433 63.1% －5,389 ・ Cash, deposits （＋¥8,350mil） ・ Accounts receivable （－¥7,838mil） Cash, deposits 14,5

  38. Slide 38: Financial Summary: KYORIN Pharmaceutical (Non-consolidated)

    Financial Summary: KYORIN Pharmaceutical (Non-consolidated) （unit : ¥million） Mar/2016 Sep/2013 Sep/2014 Sep/2015 Mar/2015 (forecast) Sales 44,933 43,922 46,157 98,452 105,300 (Exports) (1,097) (246) (504) (840) (700) Cost of Sales 15,609 17,354 18,358 38,951 ― （cost of sales ratio ）％ (34.7%) (39.5%

  39. Slide 39: Consolidated Financial Results for the Second Quarter and full year forecast

    Consolidated Financial Results for the Second Quarter and full year forecast （unit : ¥million） Mar/2016 Sep/2014 Sep/2015 Change % Y/Y Mar/2015 (forecast) Sales 51,112 52,386 ＋1,274 ＋2.5% 113,121 120,200 ■Ethical Drugs business 50,518 51,783 ＋1,264 ＋2.5% 111,771 118,600 ◆Sales of new Ethical Drugs 4

  40. Slide 40: Actual and Forecast of Main Subsidiary Companies

    Actual and Forecast of Main Subsidiary Companies （unit : ¥billion） Mar/2016 KYORIN pharmaceutical Sep/2014 Sep/2015 Mar/2015 (forecast) Sales 43.9 46.2 98.5 105.3 Operating Income 3.5 3.2 12.2 13.3 Net Income 2.9 2.5 10.4 10.0 Mar/2015 KYORIN Rimedio Sep/2014 Sep/2015 Mar/2015 (forecast) Sales 8.0 7

  41. Slide 41: Main Product Sales Update

    Main Product Sales Update （unit : ¥billion） Sep/2015 Sep/2012 Sep/2013 Sep/2014 Mar/2016 Product name Mar/2015 Actual % change (forecast) Kipres （LT receptor antagonist） 16.3 17.1 17.4 188 ＋7.9% 41.2 41.8 Mucodyne （Mucoregulant） 8.3 8.2 6.2 59 －3.6% 14.0 11.8 Sales of new Pentasa ethical drugs (Ulce

  42. Slide 42: R&D Expenses, Capex & Depreciation

    R&D Expenses, Capex & Depreciation （unit : ¥million） Mar/2016 Sep/2012 Sep/2013 Sep/2014 Sep/2015 change Mar/2015 (forecast) R&D expenses 4,892 6,119 6,674 7,270 ＋8.9% 13,514 13,400 Capital expenditure 1,181 1,618 1,557 5,637 +262.1% 2,655 8,700 Depreciation expense 1,119 1,460 1,462 1,658 ＋13.4% 3,

  43. Slide 43: Main R&D Activities -1

    Main R&D Activities -1 (as of Nov 5 2015) Ph III ~ Application submitted ※Changes from the previous announcement(July 30 2015) Stage Compound/ Therapy area/Action Origin Features Comments Code Japan Overseas PhⅢ (Europe) KRP-AB1102F Chronic Obstructive Almirall Combination of aclidinium bromide with

  44. Slide 44: Main R&D Activities -2

    Main R&D Activities -2 (as of Nov 5 2015) POC Project (Ph I ~ Ph II) ※Changes from the previous announcement(July 30 2015) Stage Compound/ Therapy area/Action Origin Features Comments Japan Overseas Code ※PhⅡ PhⅢ KRP-209 Tinnitus Merz KRP-209 (Neramexane) is expected to improve the License agreement

  45. Slide 45: Forecast performance figures disclaimer

    ■ These forecast performance figures are based on information currently available to the Company and may include uncertain factors or risk that affect our future performance. Accordingly, actual business results may materially differ from the forecasted figures due to various factors in the future.

KYORIN Holdings — H1 FY2015 Earnings Presentation on 6ix