KYORIN Pharmaceutical Co.,Ltd. · TSE:4569
KYORIN Pharmaceutical Co.,Ltd — H1 FY2019 Earnings Presentation
33 slides from KYORIN Pharmaceutical Co.,Ltd's earnings presentation, Nov 8, 2019
Slide 1: Interim Term Financial Results Ended September 2019
Interim Term Financial Results Ended September 2019 November 8 , 2019 KYORIN Holdings, Inc. President Yutaka Ogihara
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” 1
Slide 3: Outline of Consolidated Financial Results
Outline of Consolidated Financial Results 2
Slide 4: Outline of Consolidated Financial Results for the Interim Term Ended September 2019
Outline of Consolidated Financial Results for the Interim Term Ended September 2019 Change （unit : ¥billion） (forecast) Sep/18 Sep/19 Change Change(%) Announced on May 13, 2019 Net Sales 50.4 48.3 －2.1 －4.1 －3.8 Operating Income 2.9 0.8 －2.1 －72.5 －1.5 Ordinary Income 3.2 1.1 －2.1 －66.2 －1.4 Net Inc
Slide 5: Segment Sales and Breakdown of Gain and Loss
Segment Sales and Breakdown of Gain and Loss Change Change （unit : ¥billion） Sep/18 Sep/19 Change (%) (forecast) Announced on May 13, 2019 Net Sales 50.4 48.3 －2.1 －4.1 －3.8 47.6 45.5 －2.1 －4.4 －3.6 Sales of 34.0 31.3 －2.7 －7.9 －2.5 new Ethical drugs ethical Japan 33.4 30.9 －2.5 －7.4 －2.5 business d
Slide 6: Highlights of Business Performance: Net sales
Highlights of Business Performance:①Net sales （Units: ¥billion） 【 Net Sales ￥－2.1bin 】 New ethical drugs(Japan) 60 ￥－2.5bin ・Growth in Flutiform, Beova and 50.4 Nasonex sales 50 48.3 ・Influence from the suspended supply 2.8 of DESALEX ・Decreased in prescriptions of long- 2.8 listed drugs. 40 13.6 Ne
Slide 7: Highlights of Business Performance: Operating Income
Highlights of Business Performance : ②Operating Income （Units: ¥billion） 3 【 Operating Income－￥2.1bin 】 2.5 Gross Profit decreased Net Sales decreased ¥2.1billion year on year. Cost of sales ratio increased 2.0%. 2 ・Product mix －2.1 ・Fall in lump-sum revenue 1.5 2.9 R&D expenses increased ■￥5.0bin （
Slide 8: Highlights of Business Performance: Change (forecast)
Highlights of Business Performance ：③Change (forecast) Change Change (forecast) （unit : ¥billion） Sep/18 Sep/19 Change (%) Announced on May 13, 2019 Net Sales 50.4 48.3 －2.1 －4.1 －3.8 47.6 45.5 －2.1 －4.4 －3.6 34.0 31.3 －2.7 －7.9 －2.5 Ethical drugs Sales of new ethical drugs Japan 33.4 30.9 －2.5 －7.4
Slide 9: Main Product Sales Update
Main Product Sales Update Change （unit : ¥billion） Sep/18 Sep/19 Change Change(%) (forecast) Announced on May 13, 2019 Flutiform (Combination drug for asthma treatment) 6.1 6.7 ＋0.6 ＋10.3 ＋0.1 Desalex (Antiallergic Agent) 2.8 0 －2.8 － －1.8 Kipres for adult (Leukotriene Receptor Antagonist) 2.9 2.4 －
Slide 10: Trends of mainstay products and Generic drugs
Trends of mainstay products and Generic drugs 9
Slide 11: Respiratory/Otolaryngology: Flutiform
■Respiratory/Otolaryngology Flutiform 【Anti-asthmatic】 （ Units: ¥ billion ） 14.1 14.0 14.0 13.1 11.9 ■ Status in first half 2019 12.0 10.1 2nd ICS/LABA market ： expand 7.2% 7.4 7.4 10.0 half ¥56.7bln（FY18 first half） ⇒ ¥60.8bln（FY19 first half） ※1 7.0 share of Flutiform sales 6.5 11.9%（FY18 first
Slide 12: Respiratory/Otolaryngology: Desalex and Nasonex
■Respiratory/Otolaryngology （ Units: ¥ billion ） Desalex(Antiallergic Agent) Desalex 8.0 Resumption of supply 8 ■MSD has completed the pharmaceutical procedures ・Acquired certification as an overseas manufacturer of drug substance storage 6 4.9 facilities. ・Acquired approval for changes to the produ
Slide 13: Urology: Uritos and Beova
■Urology OAB market （ Units: ¥ billion ） （ Units: ¥ billion ） 10 Uritos and Beova Uritos（Overactive bladder) 8.7 8.5 8 8 7.5 7.5 7.2 2.2 1.7 6.6 0.7 2nd 5.9 6.0 6 half 6 2.9 2.9 3.8 3.7 3.6 3.1 4 29 2.9 2nd 7.5 7.5 7.2 0.7 4 half 6.6 0.6 1st Beova half 2 3.0 3.1 2 1st Uritos 3.7 3.8 3.6 3.5 3.0 3.1
Slide 14: Status of Generic Drugs
■Status of Generic Drugs Kei 35 ■Generic drugs Sales （unit : ¥billion） 31.0 32.2 29.3 30 27.7 25.0 25 16.8 2nd 16.8 15.7 half 20 14.7 15.5 14.7 15 8.1 10 1st ■ Status in first half 2019 13.6 14.2 15.3 half 13.0 5 10.3 ◆ Promotion of AG strategy 7.4 MONTELUKAST AG ￥5.4bin(＋￥0.1bln) 0 Mometasone AG
Slide 15: Consolidated Financial Results and Forecast
Consolidated Financial Results and Forecast 14
Slide 16: Consolidated Financial Results Forecast for the Year Ending March 31, 2020
Consolidated Financial Results Forecast for the Year Ending March 31, 2020 ※The results forecasts for the fiscal year ending March 31, 2020 announced on May 13, 2019 are revised. （unit : ¥billion） Y/Y Versus the FY2019 FY2019 FY2018 (original forecast) revised （revised forecast) Change Change(%) for
Slide 17: Forecast of Mainstay Product Sales
Forecast of Mainstay Product Sales ※The results forecasts for the fiscal year ending March 31, 2020 announced on May 13, 2019 are revised. （ Units: ¥ billion ） Y/Y FY2019 Versus the FY2019 revised forecast FY2018 （revised (original Change Change(%) forecast） forecast) Change Flutiform (Combination d
Slide 18: 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 2019 (est
Slide 19: Status of development pipeline
Status of development pipeline 18
Slide 20: Drug Development Pipeline: schedule in FY2019 (May 13, 2019)
Drug Development Pipeline: schedule in FY2019 shedule in FY19 [May 13, 2019] application Approval/ Launch development code PhⅠ PhⅡ PhⅢ End of the PhⅠ／PhⅡ Ad-SGE-REIC PhⅡStart 2018/6 Respiratory Expecting to create an KRP-108P 2017/6 Preparation Application in FY19 FY19 KRP-AM1977X 2017/4 Expected Re
Slide 21: Drug Development Pipeline: Progress in FY2019 2Q
Drug Development Pipeline: Progress in FY2019 2Q and schedule in FY2019 shedule in FY19 progress in FY19 2Q [ November 7,2019] application Approval/ Launch development code PhⅠ PhⅡ PhⅢ End of the PhⅠ／PhⅡ Ad-SGE-REIC PhⅡStart 2018/6 Respiratory KRP-108P 2017/6 2019/7 Application FY19 KRP-AM1977X 2017
Slide 22: Initiatives toward realization of the long-term vision HOPE 100
Initiatives toward realization of the long-term vision “HOPE 100” 21
Slide 23: Medium-term management plan HOPE100 -Stage 2-
For continuous growth（Refinement of pharmaceutical Business） Medium-term management plan “HOPE100－Stage 2－” （2016-2019） ＜Drug Discovery＞ ＜New Drug Business＞ ＜ Generic Drugs Business ＞ ＜ New businesses ＞ ■Initiatives for first-in-class ■ Increase in the Ratio of ■Promotion of Generic Drugs ■ Developm
Slide 24: FPR2 Agonist Program
<Drug Discovery> FPR2 Agonist Program BMS and Kyorin have given a total of three presentations on this FPR2 agonist (development code: BMS-986235/LAR-1219) at 2 academic conferences American Chemical Society National Meeting (San Diego) ■Aug. 28, 2019:Poster presentation Discovery of clinical candid
Slide 25: Summary of oral presentation at ACS
<Drug Discovery> Summary of oral presentation at ACS • Discovery of a conformationally constrained urea followed by optimization of FPR2 potency and selectivity, let to the identification of a highly potent and selective FPR2 agonist with excellent PK and ADME properties. • Significant improvements
Slide 26: Therapeutic agent for interstitial cystitis KRP-116D
<Drug Discovery> Therapeutic agent for interstitial cystitis "KRP-116D" (Name of Ingredient: Dimethyl Sulfoxide) Status of Development Phase 3 study (completed) ◆ Application in preparation ＊Under development for handling unapproved drugs and off-label drugs Study type: multicenter, randomized, dou
Slide 27: Efficacy endpoints (ICSI, bladder diary)
<Drug Discovery> Efficacy endpoints (ICSI, bladder diary ) Changes from baseline Changes in ICSI over time Bladder diary (after 12 weeks) (primary endpoint) (secondary endpoints) Week 0 Week 4 Week 8 Week 12 Mean frequency of urination per day 0 0 0 -1 Placebo ⊿Mean frequency of Placebo urination pe
Slide 28: Overview of study results
<Drug Discovery> Overview of study results ■Regarding the primary endpoint (ICSI) the superiority of KRP-116D compared to placebo could be verified, and thus the goal of this study was achieved ■The efficacy of KRP-116D was confirmed for all endpoints, including subjective and objective endpoints ■T
Slide 29: KRP-AM1977X and KRP-AM1977Y
＜New Drug Business＞ "KRP-AM1977X" and "KRP-AM1977Y" Generic name: lascufloxacin hydrochloride Abbreviation: LSFX Classification: quinolone antimicrobial [Aim of the development of this drug] Our aim was to develop a new therapeutic agent that is effective for treatment of pneumonia, etc., and
Slide 30: Microchannel-based Genetic Measurement Device GeneSoC
<Diagnostic business> Microchannel-based Genetic Measurement Device ｢GeneSoC®｣ GeneSoC：Gene CharacteristicsGeneSoC：Gene Sensor on aSensor Chip on a Chip ・Rapid detection of genes based on the technology of ultrafast quantitative PCR* （5-15 minutes） ・ High-sensitivity detection is possible with a tra
Slide 31: Our group's efforts in the field of infectious diseases
Our group's efforts in the field of infectious diseases Diagnostic equipment and diagnostics Microchannel-based Genetic Diagnosis Measurement Device ｢GeneSoC®｣ ※ To be released on November 11 (as laboratory equipment) Ethical drugs Treatment Prevention ※ Production/marketing approval acquired / Not
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Slide 33: News Release: KYORIN and JEIL Vibegron License Agreement in Korea
November 7, 2019 NEWS RELEASE Company: KYORIN Holdings, Inc. Representative: Yutaka Oghara Representative Director, President (Securities Code: 4569, TSE 1st Sec.) Contact: ‘Yoshinon Tamifuji Director. Corporate Planning Telephone: (0)3-3525-4707 KYORIN and JEIL Signed License Agreement for Vibegron