Kyorin Pharmaceutical Co.,ltd. · TSE:4569
Kyorin Pharmaceutical Co.,ltd — FY2018 Earnings Presentation
33 slides from Kyorin Pharmaceutical Co.,ltd's earnings presentation, May 14, 2019
Slide 1: Financial Results for Fiscal 2018
Financial Results for Fiscal 2018 May 14 , 2019 KYORIN Holdings, Inc. 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 Initiatives toward realization of the long-term vision “HOPE 100” ・Progress of Medium-Term Business Plan “HOPE 100-Stage 2-” (Fiscal 2016～2019) 2
Slide 3: Outline of Consolidated Financial Results
Outline of Consolidated Financial Results 3
Slide 4: Outline of Consolidated Financial Results for Fiscal 2018
Outline of Consolidated Financial Results for Fiscal 2018 （unit : ¥billion） Change Change Change FY2017 FY2018 Change (%) (revised (original forecast) forecast) Net Sales 110.6 113.6 ＋3.0 ＋2.7 ＋3.0 －0.8 Operating 8.8 9.0 ＋0.2 ＋1.7 ＋0.8 ＋0.4 Income Ordinary 9.3 9.4 ＋0.1 ＋1.0 ＋0.8 ＋0.2 Income Net Inco
Slide 5: Breakdown of Gain and Loss
Breakdown of Gain and Loss （unit : ¥billion） Change Change Change FY2017 FY2018 Change (%) (revised (original forecast) forecast) Net Sales 110.6 113.6 ＋3.0 ＋2.7 ＋3.0 －0.8 104.7 107.9 ＋3.2 ＋3.0 ＋3.3 －0.5 77.0 78.5 ＋1.5 ＋1.9 ＋1.4 －2.4 Sales of Japa Ethical drugs new n 73.7 77.7 ＋4.0 ＋5.4 ＋1.6 －2.2 bu
Slide 6: Highlights of Business Performance ①（Sales）
Highlights of Business Performance ①（Sales） （ Units: ¥ billion ） 113.6 【 Net Sales ¥＋3.0bln】 120 【 Ethical Drugs Sales ¥＋3.2bln】 110.6 5.8 Ethical drug sales in Japan＋4.0bln 5.9 ・Despite steady growth in Flutiform 100 sales ・The release of Beova and transfer of the 27.7 29.3 sale of Nasonex contribu
Slide 7: Highlights of Business Performance ②（Income）
Highlights of Business Performance ②（Income） （ Units: ¥ billion ） 【Operating Income ¥＋0.2bln】 Gross Profit decreased 10 Net Sales： Increased ¥3.0bln year on year Cost of sales ratio : －0.9 decreased 5.1% year on year 8 ・ Impact of drug price revisions (approximately 7%) ・ Increase in sales of generi
Slide 8: Highlights of Business Performance ③
Highlights of Business Performance ③ （Change : forecast) Change Change Change （ Units: ¥ billion ） FY2017 FY2018 Change (%) (revised (original forecast) forecast) Net Sales 110.6 113.6 ＋3.0 ＋2.7 ＋3.0 －0.8 104.7 107.9 ＋3.2 ＋3.0 ＋3.3 －0.5 77.0 78.5 ＋1.5 ＋1.9 ＋1.4 －2.4 Sales Ethical drugs of new Japan
Slide 9: Mainstay Product Sales
Mainstay Product Sales （ Units: ¥ billion ） Change Change FY2016 FY2017 Change Change(%) (revised (original forecast) forecast) Flutiform (Anti-asthmatic) 11.9 13.1 ＋1.2 ＋9.8 ＋0.8 ＋0.8 Desalex (allergic rhinitis) 4.9 3.7 －1.2 －24.1 －1.1 －4.4 Kipres for adult （LT receptor antagonist） 8.3 6.2 －2.1 －24
Slide 10: Trends of mainstay products
Trends of mainstay products 10
Slide 11: Respiratory
■Respiratory Flutiform 【Anti-asthmatic】 （ Units: ¥ billion ） 14 status of FY2018 12 ◆ ICS/LABA market ： expand 4.6% ¥115.1bln（FY2017） ⇒ ¥120.3（FY2018） ※1 10 share of Fultiform sales 11.4%（FY2017） ⇒ 12.2%（FY2018）※2 8 Effort for FY2019 14.0 13.1 ◆Aim to establish a first-line drug position in terms
Slide 12: Otolaryngology
■Otolaryngology （ Units: ¥ billion ） Desalex(Antiallergic Agent) Nasonex（Spray type allergic rhinitis remedy） （ Units: ¥ billion ） 8 12 10 6 8 4 8.0 6 12.8 4.9 4 2 3.7 6.2 2 1.0 0 0 17/3 18/3 19/3 20/3 19/3 20/3 forecast forecast status of FY2018 ■ Acquire domestic exclusive distribution rights (Ma
Slide 13: Urology
■Urology （ Units: ¥ billion ） （ Units: ¥ billion ） OAB market Uritos / Beova 100 91.3 90.2 90.9 8 86.9 80.6 2.5 80 β3 0.7 Beova 25.3 30.4 34.1 38.3 receptor 6 18.7 agonist 60 others 4 7.5 7.5 7.2 40 6.6 6.0 61.9 61.7 59.9 anticholiner Uritos 56.9 53.0 gic agent 2 20 0 0 16/3 17/3 18/3 19/3 20/3 15/3
Slide 14: Status of Generic Drugs
■Status of Generic Drugs Kei （ Units: ¥ billion ） 35 32.2 29.3 30 27.7 MONTELUKAST 25.0 AG status of FY2018 11.6 Turnover increase , MONTELUKAST AG:＋￥0.2bln 25 ・Maintain the market share of more than 50% in the GE 11.9 market. 11.7 20 8.2 Sales of generic drugs except AG (authorized generic) drug
Slide 15: Consolidated Financial Results and Forecast
Consolidated Financial Results and Forecast 15
Slide 16: Consolidated Financial Results Forecast for the Year Ending March 31, 2020
Consolidated Financial Results Forecast for the Year Ending March 31, 2020 （ Units: ¥ billion ） FY2019 Y/Y FY2018 （forecast） Change Change(%) Net sales 113.6 114.1 ＋0.5 +0.4 107.9 108.0 ＋0.1 ＋0.1 78.5 75.8 －2.7 －3.4 Sales of Ethical drugs new ethical Japan 77.7 74.4 －3.3 －4.2 business drugs 1.3 Over
Slide 17: Forecast of Mainstay Product Sales
Forecast of Mainstay Product Sales （ Units: ¥ billion ） Y/Y FY2019 FY2018 （forecast） Change Change(%) Flutiform (Anti-asthmatic) 13.1 14.0 ＋0.9 ＋7.6 Desalex (allergic rhinitis) 3.7 8.0 ＋4.3 ＋115.1 Kipres for adult （LT receptor antagonist） 6.2 4.5 －1.7 －26.5 for children 7.6 6.1 －1.5 －19.2 Nasonex （S
Slide 18: Status of development pipeline
Status of development pipeline 18
Slide 19: Drug Development Pipeline: Progress in FY2018
Drug Development Pipeline: Progress in FY2018 progress in FY18 Launch development code PhⅠ PhⅡ PhⅢ application Approval/ End of the PhⅠ／PhⅡ Ad-SGE-REIC PhⅡStart 2018/6 Respiratory KRP-108P 2017/6 Preparation KRP-AM1977X 2017/4 Infections KRP-AM1977Y Preparation KRP-116D 2017/3 Urological KRP-N118 Ph
Slide 20: Drug Development Pipeline: Progress in FY2019
Drug Development Pipeline: Progress in FY2019 progress in FY19 Launch development code PhⅠ PhⅡ PhⅢ application Approval/ End of the PhⅠ／PhⅡ Ad-SGE-REIC PhⅡStart 2018/6 Respiratory Expecting to KRP-108P 2017/6 Preparation create an Application in FY19 FY19 KRP-AM1977X 2017/4 Expected Release Infectio
Slide 21: KRP-108P, a fixed-dose combination for asthma
KRP-108P, a fixed-dose combination for asthma: Additional indications for Flutiform for children Status of Development Phase III clinical trial: Completed ◆ Application in preparation Study: Open-label, active-controlled, cross-over study in children with bronchial asthma Disease: Bronchial asthma
Slide 22: KRP-116D, a treatment for interstitial cystitis
KRP-116D, a treatment for interstitial cystitis (active ingredient: dimethylsulfoxide) Status of Development Phase III clinical trial: Completed ◆ Application in preparation *Under development as unapproved or off-labeled drugs with high medical needs Study: A multicenter, randomized, double-blind
Slide 23: Progress of Medium-Term Business Plan “HOPE 100-Stage 2-”
Progress of Medium-Term Business Plan “HOPE 100-Stage 2-” (Fiscal 2016～2019) 23
Slide 24: Outline of “HOPE 100-Stage 2-”
Outline of“HOPE 100-Stage 2-” 【Four Priority Strategies】 ①Strengthening of the Ability to Discover New Drugs ②Increase in the Ratio of New Drugs Group Business Strategy（S） ③Promotion of Generic Drugs Business by Making the Most of Its Characteristics Strategy ④Strengthening of Low Cost 【Development
Slide 25: Efforts on first-in-class drug discovery
Priority strategy: Enhance drug discovery capabilities Efforts on first-in-class drug discovery Building a system for the creation of innovative new drugs Joint Studies •Kyoto University Department of Drug Discovery for Lung Diseases •Institute of Microbial Chemistry Search in antibacterial drug fie
Slide 26: Priority strategy: Increase ratio of new drug group
Priority strategy: Increase ratio of new drug group Accelerate regrowth with new drug group and new products ・Maximize the dissemination of Flutiform, Desalex, and Beova. ・Launch and disseminate KRP-1977X. Ratio of new drug group（%） [The ratio of the new drugs group should increase as follows] Regro
Slide 27: Market creation through the launch of new ethical drugs
Priority strategy: Increase ratio of new drug group Market creation through the launch of new ethical drugs Medium-term management plan “HOPE100－Stage 2－” （2016-2019） Launch four new products during the stage 2 period and popularize them and Flutiform as much as possible FY2016～ Current State ～FY201
Slide 28: AG strategy and strengthening of ability to perform business
Priority Strategy “Promotion of Generic Drugs Business by Making the Most of Its Characteristics“ AG strategy and Strengthening of ability to perform business AG strategy Maintain the quantity-based share Montelukast AG of more than 50% in the GE market Mometasone AG Aim to launch (FY2019) Conside
Slide 29: Consolidation of the Group’s production functions
Priority Strategy "Strengthening of Low Cost“ Consolidation of the Group’s production functions Change of the cost structure by ensuring optimization within the Group KYORIN Pharmaceutical Facilities Co., Ltd Commences full-scale operation on April 1, 2018 Noshiro plant (Akita) Inami plant (Toyama）
Slide 30: Diagnostic business
Fostering strategy: Diagnostic business Aim to be the next core business Characteristics ・Rapid detection of genes based on the technology of ultrafast quantitative PCR* （5-15 minutes） ・ High-sensitivity detection is possible with a trace amount Up to 4 Detection Units can be added of the sample imm
Slide 31: Continuous Growth
Performance Continuous Growth Medium-term management plan “HOPE100－Stage 2－” （2016-2019） ＜Target value＞ ＜FY2019（Forecast）＞ Factor ■the new drug business (in Japan) ・Delay in the progress of KRP-AM1977X the average ・Decrease in sales due to the temporary the average suspension of the supply of Desale
Slide 32: Shareholder Returns
Shareholder Returns Basic Policy ・While maintaining the sound financial base, we aim to improve the capital efficiency through growth investment and returns to shareholders. ・We will maintain stable dividends taking DOE (Dividend on Equity ratio) into account. Dividend per share for fiscal 2018 (est
Slide 33: Develop growth potential and follow a growth path
Important points in facilitating the FY2019 business strategy Develop growth potential and follow a growth path 33