KYORIN Pharmaceutical Co.,Ltd. · TSE:4569
KYORIN Pharmaceutical Co.,Ltd — Q1 FY2018 Earnings Presentation
31 slides from KYORIN Pharmaceutical Co.,Ltd's earnings presentation, Aug 8, 2018
Slide 1: First quarter of fiscal 2018 IR meeting
First quarter of fiscal 2018 IR meeting August 8 , 2018 KYORIN Holdings, Inc. P President id t Minoru Mi H Hogawa
Slide 2: Overview of consolidated results
Overview of consolidated results - consolidated results, and progress of the main products Consolidated Financial Results and Forecast Changes in Capital Policy 2
Slide 3: Overview of consolidated results
Overview of consolidated results 3
Slide 4: Outline of First Quarter Consolidated Financial Results
Outline of First Quarter Consolidated Financial Results for the Fiscal Year Ending March 31, 2019 YoY Progress to First quarter First quarter （¥ billion） Jun / 2017 Jun / 2018 Interim term forecast(%) Change change（%） Net sales 26.5 25.1 －1.4 －5.0 50.1 Operating income 2.6 1.3 －1.3 －49.1 69.5 Ordina
Slide 5: Highlights of Business Performance ① (Sales)
Highlights of Business Performance ① （Sales ） Sales （ Units: ¥ billion） 【 Net Sales ¥ －1.4bln】 30 26 5 26.5 Healthcare Business¥＋0.1bln 25.1 25 1.3 ・Growth of RUBYSTA and Milton 1.4 6.9 【 Ethical Drugs Sales ¥ －1.4bln】 20 7.5 0.2 Generic drugs ¥＋0.6bln 0.1 ・Increase of MONTELKAST AG sales 15 【 Ethic
Slide 6: Main Product Sales Update
Main Product Sales Update （ Units: ¥ billion ） Progress to Jun/2017 Jun/2018 change change（%） Interim term forecast(%) Flutiform (Combination drug for asthma treatment) 2.8 3.0 ＋0.2 ＋9.4 52.5% U it （Kyorin） Uritos（K i ） (Overactive bladder) 1.9 1.7 －0.2 －8.8 50.1% Desalex ((Antiallergic g Agent) g )
Slide 7: Highlights of Business Performance ② (Income)
Highlights of Business Performance ② （Income ） （ Units: ¥ billion） 【Operating Income ¥－1.4bln】 3 Gross Profit decreased Net Sales： 2.5 decreased ¥1.4bln year on year Cost of sales ratio : Increased 2.6% year on year ・Decreased in sales of drugs due to drug price 2 －1.4 revisions. (Kyorin Pharmaceuti
Slide 8: Forecast of Business Performance Second quarter
Forecast of Business Performance Second quarter （Income ） （ Units: ¥ billion） 【Operating Income ¥＋0.5bln】 2.5 Gross Profit decreased Net Sales： decreased ¥0.6bln year on year 2 ・Despite steady growth in Flutiform and Desalex sales l 0 Cost of sales ratio : Increased about1.5% year on year 1.5 ・decre
Slide 9: Consolidated Financial Results and Forecast
Consolidated Financial Results and Forecast 9
Slide 10: 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 11: 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 12: Changes in Capital Policy
RMS a-—VLORUTT. Va Changes in Capital Policy 12
Slide 13: Changes in Capital Policy
Changes in Capital Policy Before the change ・While maintaining the sound financial base, we adopt the capital policy ensuring both growth investment and stable return to shareholders. As for the return to shareholders, we aim for “stable dividends” on a basis of the present dividend standard. Reason
Slide 14: Shareholder Returns
Shareholder Returns Basic Policy(After the change) ・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. Dividends FY2018 FY20
Slide 15: Drug Development Pipeline: Progress in FY2017, schedule of FY2018
Drug Developmet Pipeline: Progress in FY2017, schedule of FY2018 schedule of FY18 progress in FY18 1Q 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
Slide 16: Accelerate regrowth with new drug group and new products
Accelerate regrowth with new drug group and new products ・Maximize the dissemination of Flutiform, Desalex, PENTASA Granules, Uritos and Nasonex. ・Launch and disseminate KRP-114V and KRP-1977X. Ratio off new [The ratio of the new drugs group should increase as follows] drug group（%） Regrowth with Fl
Slide 17: Approach to Drug Discovery and Status of R&D Pipeline
Approach to Drug Discovery and Status of R&D Pipeline Kyorin Holdings, Inc. August 8, 8 2018 Shigeru Ogihara, Senior Executive Director ((Senior Executive Director and General Manager, Discovery Research HQs, Kyorin Pharmaceutical Co., Ltd)
Slide 18: Approach to first-in-class drug discovery; Status of R&D pipeline
Approach to first-in-class drug discovery through “selection selection and concentration” scheme: Focus on fibrosis research Status of R&D pipeline 2
Slide 19: Approach to First-in-class Drug Discovery
Approach to “First-in-class” Drug Discovery Partnership WRC ActivX, USA WRC: Watarase Research Center O Open Innovation i O Open Innovation i Academia and Global and Domestic Ventures Pharma Companies Selection and Concentration External drug Research Focuses discovery Fibrosis Kinase programs Multi
Slide 20: Organ Fibrosis
Organ Fibrosis Functional damage of organs by excessive accumulation of collagens and so on Cause of the onset is not clear, clear and progression is irreversible. irreversible Development of effective drugs is required. Skin (scleroderma: 20k)b Lung (IPF: 13k)a Liver (NASH: 7 million)a Pancre
Slide 21: Outline of Organ Fibrosis
Outline of Organ Fibrosis For organ fibrosis, there are common causes and factors irrespective of organ and organ specific ones Organ specific C Common • Virus infections Org Lung • Inflammatory cell • Alveolar epithelial cell infiltration t at o gan-spe damage • Growth of myofibroblasts • Macrophag
Slide 22: Drug Discovery for Pulmonary Fibrosis
Drug Discovery for Pulmonary Fibrosis Specific causes/factors Common causes/factors Pathology Stage Early cell Dysfunction of Fibrotic factor Progress of damage cells production fibrosis Type 2 alveolar epithelial cells Cells Macrophage involved Fibroblasts ●Novel target A ●Novel target C(Nucleic ac
Slide 23: Status of R&D Pipeline
St t Status off R&D Pipeline Pi li 7
Slide 24: Status of R&D Pipeline
Status of R&D Pipeline Highlights in FY2018 As of July 31, 2018 Projects Ph1 Ph2 Ph3 NDA Appr/Launch Ph1／Ph2 ended Ad-SGE-REIC Ph2 start June Respi Gene therapy (MPM) 2018 ratory KRP-108P June 2017 P.9 Asthma combo. inhaler KRP AM1977X KRP-AM1977X Apr 2017 Aim for launch in FY2019 Infect Fluoroquino
Slide 25: Outline of Ad-SGE-REIC
Outline of Ad-SGE-REIC Expression of REIC protein in various cancer cells 2.0 DKK3 mRNA expression 1.5 relative 1.0 Malignant mesothelioma cells 0.5 0.0 Igaku no ayumi ayumi. 2018; 265(5); 422-428. 422 428 786-O O HUVEC C HMEC C MSTO-211H H LNCaP clone FGC C NHBE E IMR90 0 HFL1 1 NCI-H226 6 NCI-H28
Slide 26: Outline of Ad-SGE-REIC: Mechanism of Action
Outline of Ad-SGE-REIC Mechanism of Action Ad-SGE-REIC is a gene therapy product in which the cancer- suppressing gene REIC/Dkk-3 discovered in Okayama Univ is mounted on an adenoviral vector as a therapeutic gene gene. Selective cytotoxicity against Activation of anticancer immunity cancer cells By
Slide 27: Anti-cancer Immunity Activation by Ad-SGE-REIC
Anti-cancer Immunity Activation by Ad-SGE-REIC Mouse subcutaneous tumor model (1) (2) Strain: E.G7-OVA . Igaku no ayumi 2018; 265(5); 422-428. (1) Increase in cancer antigen-specific cytotoxic T cells was confirmed both in the tumor treated with the product and in the spleen. (2) Increase in cancer
Slide 28: Development status of Ad-SGE-REIC
Development status of Ad-SGE-REIC Ph1/2 Study period July 2015〜 Japanese MPM patient with standard treatment ineffective or without S bj t Subjects appropriate treatment Primary endpoint: Safety, Estimation of maximum tolerated dose Objects Secondary endpoint: Efficacy Administration Local administr
Slide 29: Expansion of product line-up in urology field
Expansion of product line-up in urology field Causes of frequent urination and Nocturia incontinence Overactive Bladder Nocturia (OAB) Uritos® (antichorinergic) KRP-N118 (vasopressin V2 KRP 114V (β3 agonist) KRP-114V i t) Agonist) And for Interstitial cystitis y KRP-116D under development Offer trea
Slide 30: Outline of KRP-N118
Outline of KRP-N118 ◆Indication: Nocturia caused by night polyuria ◆MOA: Antidiuretic effect by promoting water re-absorption from renal collecting tubule by vasopressin V2 receptor agonistic action ◆Dosage: Once daily before bedtime, oral dissolution tablets ◆Features A small molecular compound,
Slide 31: Development status of KRP-203
Development status of KRP-203 GvHD Ref: ClinicalTrials.gov (March 2018) Stage Targeted Recruited Intervention 10 10 Methotrexate＋Ciclosporin Part 1 Novartis conducted Ph.1b (from 2013) to evaluate the preventive effect of GvHD after hematopoietic p stem cell transplantation p in p patients with he