KYORIN Pharmaceutical Co.,Ltd. · TSE:4569
KYORIN Pharmaceutical Co.,Ltd — H1 FY2016 Earnings Presentation
42 slides from KYORIN Pharmaceutical Co.,Ltd's earnings presentation, Nov 8, 2016
Slide 1: Interim Term Financial Results Ended September 2016
Interim Term Financial Results Ended September 2016 November 8 , 2016 g Inc. KYORIN Holdings, President Minoru Hogawa
Slide 2: Outline of Consolidated Financial Results
Outline of Consolidated Financial Results Trends of mainstay products and Generic drugs Consolidated Financial Results Forecast and Dividends Status of development pipeline 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 2016
Outline of Consolidated Financial Results for the Interim Term Ended September 2016 （unit : ¥billion） Change M /1６ Mar/1６ Mar/1７ S /15 Sep/15 S /16 Sep/16 C Change C Change(%) (%) (forecast) (forecast) Net Sales 52 4 52.4 54 6 54.6 ＋2 2 ＋2.2 ＋4 3 ＋4.3 ＋0 7 ＋0.7 119 5 119.5 120 0 120.0 Operating Inco
Slide 5: Segment Sales
Segment Sales （unit : ¥billion） Change Sep/15 Sep/16 Change Change(%) ((forecast)) Net Sales 52.4 54.6 ＋2.2 ＋4.3 ＋0.7 49.7 51.9 ＋2.2 ＋4.4 ＋0.7 42.4 41.6 －0.8 －1.8 －0.2 Ethical drugs Sales of new business ethical drugs Japan 41.8 41.3 －0.5 －1.2 －0.2 Overseas 06 0.6 03 0.3 03 －0.3 42 3 －42.3 0 Generic
Slide 6: Breakdown of Gain and Loss
Breakdown of Gain and Loss （unit : ¥billion） Change Change Sep/15 Sep/16 Change (%) (forecast) Net Sales 52.4 54.6 ＋2.2 ＋4.3 ＋0.7 Cost of Sales 21.6 23.8 ＋2.2 ＋10.5 － SG&A 26 7 26.7 27 1 27.1 ＋0 4 ＋0.4 ＋1 5 ＋1.5 － R&D expenses 7.3 7.3 0 ＋0.8 ＋1.0 SG&A expenses 19.5 19.8 ＋0.3 ＋1.8 － Operating Income
Slide 7: Highlights of Business Performance
Highlights of Business Performance （Units: ¥billion） ¾Net Sales increased ¥2.2billion year 50 Cost of Sales Ratio Cost of Sales Ratio on year. 41.2% 43.6% ・increase of main products (Flutiform ,etc.) Launch of an authorized generic ・Launch Cost of Sales Cost of Sales drug for KIPRES 40 21.6 23.8 ¾Co
Slide 8: Mainstay Product Sales
Mainstay Product Sales （unit : ¥billion） Change Sep/15 Sep/16 Change Change(%) (forecast) Kipres 18 8 18.8 17 8 17.8 1.0 －1 0 5.2 －5 2 ＋0 2 ＋0.2 Flutiform 3.0 4.5 ＋1.5 ＋51.1 －0.9 Uritos 3.7 3.8 ＋0.1 ＋2.0 ＋0.2 P t Pentasa 81 8.1 79 7.9 02 －0.2 30 －3.0 ＋0 5 ＋0.5 Mucodyne 5.9 4.4 －1.5 －26.6 －0.4 Generi
Slide 9: Trends of mainstay products and Generic drugs
Trends of mainstay products and Generic drugs 8
Slide 10: Kipres: Bronchial asthma and allergic rhinitis treatment
■New drugs group Kipres 【Bronchial asthma and allergic rhinitis treatment】 Sales （unit : ¥billion） 50 45 44.1 ■status in first half 2016 40.2 41 2 41.2 40 39.6 zLT antagonists market ： shrink 5% ¥58.8bln（FY15 first half） ⇒ ¥56.1bln（FY16 first half） ※1 36.8 35 33.3 zshare of Kipres sales 38.5%（FY15 f
Slide 11: Flutiform: Anti-asthmatic
■New drugs group Flutiform 【Anti-asthmatic】 Sales （unit : ¥billion） 14 12.9 ■ status in first half 2016 zICS/LABA market ： expand 6% 12 ¥51 4bln（FY15 first half） ⇒ ¥54.3bln（FY16 ¥51.4bln（FY15 ¥54 3bln（FY16 first half） ※1 zshare of Flutiform sales 10 6.6%（FY15 first half ） ⇒ 9.3%（FY16 first half ） ※2
Slide 12: DESALEX: Antiallergic Agent
■New drugs group DESALEX 【Antiallergic Agent】 Approval received (MSD K.K., Sep. 2016) Launch scheduled for Nov. 2016 S l fforecast：¥1.9 Sales t ¥1 9 billi billion (FY2016 sales) l ) ・Exclusive rights to market obtained from MSD K.K. (May 2016) ・Kyorin and Kaken Pharmaceutical signed a Contract f
Slide 13: NASONEX Nasal (Allergic rhinitis therapeutics)
NASONEX Nasal（ Allergic rhinitis therapeutics） ■Concluded co-promotion contract with MSD (Sep. 2016) ・Detailing activities targeting departments of internal medicine, otorhinology, and pediatrics ■Start promotion (November 2016) 【 Product features】 【About the market】 Efficacy ： Steroid nasal spray M
Slide 14: Status of Generic Drugs
■Status of Generic Drugs Sales （unit : ¥billion） 25 ■ Status in first half 2016 zLaunch of an authorized generic drug for KIPRES (Sep. 2016) MONTELUKAST Tablets 5mg“KM”, 10mg”KM” 21.5 zTurnover increase rate, excluding AG : ＋15.4% Increase of Health insurance pharmacy market’s sales 20 ■ effort for
Slide 15: Consolidated Financial Results Forecast and Dividends
Consolidated Financial Results Forecast and Dividends 14
Slide 16: Consolidated Financial Results Forecast for the Year Ending March 31, 2017
Consolidated Financial Results Forecast for the Year Ending March 31, 2017 （unit : ¥billion） Y/Y FY2016 FY2015 Change g Change(%) g ( ) forecast Net sales 119.5 120.0 ＋0.5 ＋0.4 114.0 114.0 0 ＋0.0 98.5 92.4 －6.1 －6.2 Ethical drugs Sales of new business ※ ethical drugs Japan 92.9 88.5 －4.4 －4.8 Overse
Slide 17: Forecast of Mainstay Product Sales
Forecast of Mainstay Product Sales （unit : ¥billion） FY2016 FY2015 Forecast Change g Change(%) g ( ) Kipres 44.1 33.3 －10.8 －24.3 Flutiform 7.2 12.9 ＋5.7 ＋78.4 Uritos 7.5 7.8 ＋0.3 ＋5.0 Desalex － 1.9 ＋1.9 － Pentasa 16.1 15.8 －0.3 －1.7 Mucodyne 13.0 10.8 －2.2 －16.7 Generic drugs 15.5 21.5 ＋6.0 ＋39.0 1
Slide 18: Shareholder Returns
Shareholder Returns Basic Policy -While maintaining g the sound financial base, adopt the capital policy y ensuring g both growth investment and stable return to shareholders. - In shareholders return, aim for stable dividends. Dividend per share for fiscal 2016 (estimate): ¥58 (including interim di
Slide 19: Status of development pipeline
St t off development Status d l t pipeline i li 18
Slide 20: Drug Development Pipeline: schedule of FY2015
Drug Development Pipeline : schedule of FY2015 schedule of FY2015 Approval/ Product & development code PhⅠ PhⅡ PhⅢ application Launch Respiratory Ad-SGE-REIC 15/7 PhⅠ／PhⅡ KRP-AM1977X End of the PhⅢ FY18 Expected Release Infections KRP-AM1977Y 16/3 PhⅢ FY18 Expected Release Otolaryng KRP-209 15/8 PhⅡ
Slide 21: Antibacterial agent: KRP-AM1977X, KRP-AM1977Y
Antibacterial agent : KRP-AM1977X , KRP-AM1977Y generic name : Lascufloxacin （LSFX ） 【 Features 】 H ・Have ab broad d antibacterial tib t i l spectrum t ffrom GGram-positive iti b bacteria t i tto G Gram-negative ti b bacteria t i andd atypical bacteria. Also have stronger antibacterial activity to
Slide 22: Intrapulmonary Pharmacokinetics of Lascufloxacin (AM-1977)
Intrapulmonary Pharmacokinetics of Lascufloxacin (AM-1977) KRP-AM1977X showed a penetration into the excellent lung Lascufloxacin concentration-time profiles in plasma and ELF. *1 1 L Lascufloxacin fl i concentration-time t ti ti profiles fil iin plasma l and AM *1 d AMs 1 100 AM AMs Conccentration
Slide 23: reference
Ride a-VULORUTT. reference 22
Slide 24: Uritos: Overactive bladder
■New drugs group Uritos 【 Overactive bladder 】 Sales （unit : ¥billion） 9 8.1 7.8 8 7.5 73 7.3 7.5 ■ status in first half 2016 7 zOAB market ： expand 5% 6.3 ¥42.6bln （FY15 first half） ⇒ ¥44.7bln （FY16 first half）※1 6 4.4 2 nd zshare of Uritos sales 3.9 3.8 4.2 4 2 half 9.6% （FY15 first half） ⇒ 9.3% （
Slide 25: Pentasa: Ulcerative colitis and Crohn's disease treatment
■Original products group Pentasa 【 Ulcerative colitis and Crohn’s disease treatment 】 Sales （unit : ¥billion） 20 18.0 17.6 18.6 ■ status in first half 2016 17 2 17.2 16.1 15.8 zmarket（Mesalazine etc.）： shrink 7％ ・¥19.6bln（FY15 first half ） ⇒ ¥18.2bln（FY16 first half ） ※1 15 zshare of Pentasa sales 8
Slide 26: Mucodyne: Mucoregulating drug
■Original products group Mucodyne 【 Mucoregulating drug】 Sales （unit : ¥billion） 25 21.5 ■ status in first half 2016 0 6 19.1 20 18.4 zexpectorant market： shrink 9% ¥18.0bln（FY15 first half） ⇒ ¥16.3bln（FY16first half） ※1 15 12.4 14.0 zshare of Mucodyne sales in expectorant market 10.8 13.0 37.8%（FY1
Slide 27: P&L Summary: Consolidated Results (1)
P&L Summary: Consolidated Results – (1) （unit : ¥million） ＜ Breakdown ＞ Sep/2015 Sep/2016 Year on Year ■ Sales ¥54,628mil （＋¥2,242mil） Actual % Sales Actual % Sales % Change Change ● Ethical drug sales in Japan ¥41,272mil （－¥490mil） Sales 52,386 100.0% 54,628 100.0% ＋4.3% ＋2,242 Sep/2015 ⇒ Sep/2016
Slide 28: P&L Summary: Consolidated Results (2)
P&L Summary: Consolidated Results – (2) （unit : ¥million） Sep/2015 Sep/2016 ＜ Breakdown ＞ Actual % Sales Actual % Sales % Change Change ◆Cost of Sales Ratio : ＋4.3% ＋2,242 up 2.4 percentage points Y/Y (41.2％→43.6％) Sales 52,386 100.0% 54,628 100.0% ・Drug price revisions Cost of Sales 21,561 41.2% 23
Slide 29: BS Summary: Consolidated Results
BS Summary: Consolidated Results Mar/2016 Sep/2016 （ Units: ¥ million ） Actual %total Actual % total change ＜ Breakdown ＞ Current Assets 138,483 70.0% 130,610 69.4% －7,873 ■C tA ■Current Assett ： － ¥ 7,873mil 7 873 il Cash, deposits 45,712 51,881 ・ Cash, deposits （＋ ¥6,196mil） Notes and accounts rec
Slide 30: Financial summary (Consolidated)
Financial summary (Consolidated) （unit : ¥million） Mar/2016 Mar/2017 Sep/2014 Sep/2015 Sep/2016 (forecast) Sales 51,112 51 112 52,386 52 386 54,628 54 628 119,483 119 483 120,000 120 000 (Exports) (332) (594) (343) (5,586) (3,800) Cost of Sales 21,340 21,561 23,830 47,360 ― (cost of Sales Ratio )(%)
Slide 31: Segment information for the Second Quarter Ended Sep 30, 2016
Segment information for the Second Quarter Ended Sep 30, 2016 Sales,, Profit or Loss of each report p segment g （unit : ¥billion） Sales change Y/Y Profit change Y/Y Net Sales (total) 54.6 ＋2.2 3.7 －0.4 Ethical drugs business 51.9 ＋2.2 3.6 －0.4 ◆Sales of new ethical drugs 41.6 0.8 －0.8 ○Japan 41.3 －0
Slide 32: Consolidated Financial Results for the Second Quarter and full year forecast
Consolidated Financial Results for the Second Quarter and full year forecast （unit : ¥million） % Sep/2016 % Mar/2017 Sep/2015 Sep/2016 Change Mar/2016 (forecast) Y/Y (forecast) forecast Sales 52,386 54,628 ＋2,242 ＋4.3% 53,900 ＋1.4% 119,483 120,000 ■Ethical Drugs b i business 49 741 49,741 51,936 , ＋
Slide 33: P&L summary: KYORIN Pharmaceutical (Non-consolidated) (1)
P&L summary : KYORIN pharmaceutical (Non-consolidated)-(1) （unit : ¥million） ＜ Breakdown ＞ Year on Year Sep/2015 Sep/2016 ■ Sales ¥47,396mil （＋¥1,239mil） Actual % Sales Actual % Sales % Change Change ● Ethical drug sales in Japan ¥40 182mil ¥40,182mil ¥422mil） （－¥422mil） （ S l Sales 46,157 100.0% 47
Slide 34: P&L summary: KYORIN Pharmaceutical (Non-consolidated) (2)
P&L summary : KYORIN pharmaceutical (Non-consolidated)-(2) （unit : ¥million） ＜ Breakdown ＞ Sep/2015 Sep/2016 Actual % Sales Actual % Sales % Change Change ◆Cost of Sales Ratio : Sales 46,157 100.0% 47,396 100.0% ＋2.7% ＋1,239 up 3.4 percentage points Y/Y (39.8％→43.2％) Cost of Sales 18,358 39.8% 20,47
Slide 35: BS Summary: KYORIN Pharmaceutical (Non-consolidated)
BS Summary: KYORIN Pharmaceutical (Non-consolidated) （unit : ¥million） Mar/2016 Sep/2016 ＜ Breakdown ＞ Actual % total Actual % total change Current Assets 102,859 66.1% 96,497 65.1% －6,362 ■Current Assets ：－¥6,362mil ・ Cash, deposits （＋¥5,893mil） Cash, deposits 22,326 28,219 ・ Accounts receivable （－
Slide 36: Financial Summary: KYORIN Pharmaceutical (Non-consolidated)
Financial Summary: KYORIN Pharmaceutical (Non-consolidated) （unit : ¥million） Mar/2017 Sep/2014 Sep/2015 Sep/2016 Mar/2016 (forecast) Sales 43,922 46,157 47,396 106,390 106,400 (Exports) (246) (504) (221) (5,343) (3,600) Cost of Sales 17,354 18,358 20,472 40,798 ― （cost of sales ratio ）％ (39.5%) (39
Slide 37: Main Product Sales Update
Main Product Sales Update （unit : ¥billion） Sep/2016 Sep/ Mar/ Sep/ Sep/ Sep/ % Mar/ 2015 2016 2017 2013 2014 forecast 2016 (forecast) (forecast) Actual % change Kipres （LT receptor antagonist） 17 1 17.1 17 4 18.8 17.4 18 8 17.8 －5.2% 17.6 +1.2％ 44 1 33.3 44.1 33 3 Flutiform （Combination drug for as
Slide 38: R&D Expenses, Capex & Depreciation
R&D Expenses, Capex & Depreciation （unit : ¥million） Mar/2017 Sep/2013 Sep/2014 Sep/2015 Sep/2016 change Mar/2016 (forecast) R&D expenses 6,119 6,674 7,270 7,327 ＋0.8% 13,019 13,500 Capital expenditure 1 618 1,618 1 557 1,557 5 637 5,637 1 383 1,383 －75 5% －75.5% 7 218 7,218 4 700 4,700 Depreciation
Slide 39: Main R&D Activities -1
Main R&D Activities -1 (as of November 7 2016) Ph III ~ Application submitted ※Changes from the previous announcement(July 29 2016) Stage Compound/ Therapy area/Action Origin Features Comments J Japan O Overseas Code PhⅢ PhⅡclinical KRP-114V Overactive bladder Merck & KRP-114V is expected to improve
Slide 40: Main R&D Activities -2
Main R&D Activities -2 (as of November 7 2016) POC Project (Ph I ~ Ph II) 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 with (8/2015) Merz patients' annoyance and diffic
Slide 41: Main R&D Activities -3
Main R&D Activities -3 (as of November 7 2016) Licensing development（preclinical） Licensee / Stage/ Compound/ Therapy Collaborative Origin Features Comments Overseas Code area/Action research PhⅠ KRP-203 Novartis GVHD In-house Sphingosine-1-Phosphate Receptor Agonist . License agreement with Novarti
Slide 42: 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