KYORIN Pharmaceutical Co.,Ltd. · TSE:4569

KYORIN Pharmaceutical Co.,Ltd — FY2021 Earnings Presentation

39 slides from KYORIN Pharmaceutical Co.,Ltd's earnings presentation, May 12, 2022

  1. Slide 1: FY 2021 Financial Results

    FY 2021 Financial Results Ended March 2022 May 12 , 2022 KYORIN Holdings, Inc. Representative Director, President and Chief Executive Officer Yutaka Ogihara

  2. Slide 2: Outline of Consolidated Financial Results

    Outline of Consolidated Financial Results Trends of mainstay products Consolidated Financial Forecast Status of R&D Pipeline Initiatives toward realization of the long-term vision “HOPE 100” Medium-Term Business Plan “HOPE 100-Stage3-”(Fiscal Year 2020～2023） Renovation the group structure 2

  3. Slide 3: Outline of Consolidated Financial Results

    Outline of Consolidated Financial Results 3

  4. Slide 4: Breakdown of Gain and Loss

    Breakdown of Gain and Loss （Units: ¥billion） Vs forecast (announced Year-on-year on May 11, 2021) FY2020 FY2021 Change Change (%) Change Net Sales 102.9 105.5 n/a n/a +2.9 New ethical drugs, etc. (Japan) 69.7 69.7 n/a n/a +1.1 New ethical drugs (Overseas) 1.0 1.0 n/a n/a +0.2 Generic drugs 32.2 34.8

  5. Slide 5: Highlights of Business Performance (1/3)

    Highlights of Business Performance (1/3) (Units: ¥billion) 120.0 105.5 New ethical drugs, etc. (Japan): sales remained flat 102.9 100.0 【Reason of increase】 ●New drugs (Dezalex, Beova, Lasvic) grew 32.2 34.8 ●Increase in sales of long-listed products (Pentasa, Mucodyne etc.) 80.0 【Reason of decrease

  6. Slide 6: Highlights of Business Performance (2/3)

    Highlights of Business Performance (2/3) Net sales increased 100.0 Cost of sales ratio increased Cost of Cost of 【Reason of decrease】 sales sales ●Sales of new drugs increased 51.3 56.1 80.0 【Reasons of increase】 ●Impact of NHI drug price revision Cost of Cost of sales sales (KYORIN Pharmaceutical :

  7. Slide 7: Highlights of Business Performance (3/3)

    Highlights of Business Performance (3/3) （Units: ¥billion） Year-on-year vs forecast (announced on May 11, 2021) FY2020 FY2021 Change Change (%) Change Net Sales 102.9 105.5 n/a n/a +2.9 New ethical drugs, etc. (Japan) 69.7 69.7 n/a n/a +1.1 New ethical drugs (Overseas) 1.0 1.0 n/a n/a +0.2 Generic d

  8. Slide 8: FY2021 Main Product Sales Update

    FY2021 Main Product Sales Update （Units: ¥billion） FY2020 FY2021 Year-on-year vs Forecast (announced on May 22, 2021) Change Change (%) Change Flutiform (Combination drug for asthma treatment) 13.3 12.6 -0.7 -5.5 -1.3 Desalex (Antiallergic Agent) 5.7 7.1 +1.4 +24.0 -0.1 Beova (KYORIN) (β3 adrenergic

  9. Slide 9: Impact of a Fire at Nishinihon Delivery Center

    Impact of a Fire at Nishinihon Delivery Center Occurrence Status Date and time of Fire: November 29, 2021 at 8:50 am Place: Hitachi Transport System West Japan Co., Ltd. (Konohana-ku,Osaka Japan) Damages and Impact on Product Supply Due to the inventory storage status of KYORIN Pharmaceutical and KY

  10. Slide 10: Trends of Mainstay Products and Generic Drugs

    Trends of Mainstay Products and Generic Drugs 10

  11. Slide 11: Flutiform (Anti-asthmatic)

    Flutiform（Anti-asthmatic） Market Sales ICS/LABA market Flutiform share （Units: ¥billion） （Units: %） （Units: ¥billion） Sales 140.0 20 14 120.0 15.5 15.9 12 13.2 15 100.0 12.2 11.4 10 80.0 10 8 14.6 60.0 115.1 120.3 123.2 13.1 13.3 12.6 101.3 6 12.0 90.4 40.0 5 4 20.0 2 0.0 0 0 18/3 19/3 20/3 21/3 22/

  12. Slide 12: Desalex (Antiallergic Agent)

    Desalex (Antiallergic Agent) （Units: ¥billion） Antihistamine market （Units: ¥billion） Sales New drugs long-listed drugs and generics Approx. Desalex share 15 200.0 178.2 180.0 8 162.1 156.2 160.0 137.0 140.0 10 125.6 6 100.0 120.0 Supply 95.7 85.2 suspended : 100.0 about 10 months 98.6 4 8.0 83.7 80

  13. Slide 13: Beova (OAB)

    Beova (OAB) OAB market β3 receptor antagonist others Sales anticholinergic agent （Units: ¥billion） （Units: ¥billion） Beova(KYORIN) share (%) 100 96.3 97.7 20 14 91.0 91.3 93.0 12 80 40.2 30.3 15 47.8 10 56.9 53.0 60 8 10.2 10 14.1 8.6 6 40 57.5 8.6 48.5 62.7 4 7.3 5 20 38.3 5.0 2 4.3 34.1 0.6 0 0.7

  14. Slide 14: Removal of Shipping Adjustment for Beova

    Removal of Shipping Adjustment for Beova Removal of shipping adjustment is scheduled in August 2022 Building of production system for stable supply  Forecast for removal of shipping adjustment in August 2022 by enhancement facilities at each OEM manufacture and efforts for launch second source (new

  15. Slide 15: Lasvic (New quinolone synthetic antibacterial agent)

    Lasvic (New quinolone synthetic antibacterial agent) Market Sales Oral antimicrobial market Sales (include injection drug) Lasvic share 150.0 15 3 100.0 10 2 3.0 125.9 50.0 105.6 63.3 62.3 5 1 96.2 2.9 1.8 1.9 0.9 1.1 0.9 0.0 0 0 18/3 19/3 20/3 21/3 22/3 20/3 21/3 22/3 23/3 (Forecast) Copyright © 20

  16. Slide 16: Status of Generic Drugs

    Status of Generic Drugs Sale Status in FY2021 （Units: ¥billion） ●Montelukast AG, Mometasone AG, 40 36.7 Imidafenacin AG maintain the market share 34.8 32.2 0.5 IMIDAFENACIN AG of more than 50% in the GE market 0.8 ● Released in June 2021: 3 ingredients 5 items 35 31.0 3.6 MOMETASONE AG 0.7 ○ Eszopic

  17. Slide 17: Consolidated Financial Forecast FY2022

    Consolidated Financial Forecast FY2022 17

  18. Slide 18: Consolidated Financial Forecast FY2022

    Consolidated Financial Forecast FY2022 (Unit: ¥billion) Year-on-year FY2021 FY2022 Change Change (%) Net Sales 105.5 112.0 +6.5 +6.1 New ethical drugs, etc. (Japan) 69.7 74.5 +4.8 +6.8 New ethical drugs (Overseas) 1.0 0.7 -0.3 -32.2 Generic drugs 34.8 36.7 +1.9 +5.5 Cost of sales 56.1 - - - SG&A 44.

  19. Slide 19: Forecast of Mainstay Products Sales

    Forecast of Mainstay Products Sales Year-on-year (Unit: ¥billion) FY2021 FY2022 (Forecast) Change Change (%) Flutiform (Combination drug for asthma treatment) 12.6 12.0 -0.6 -4.6 Desalex (Antiallergic Agent) 7.1 8.0 +0.9 +13.6 Beova(KYORIN) (β3 adrenergic receptor agonist overactive bladder therapeu

  20. Slide 20: Shareholders Returns

    Shareholders Returns ● While maintaining the sound financial base, we aim to improve the capital Capital efficiency through growth investment and returns to shareholders Policy ● We will maintain stable dividends taking DOE (Dividend on Equity ratio) into account Dividend FY2022 FY2019 FY2020 FY2021

  21. Slide 21: Status of R&D Pipeline

    Kyorin @) | Status of R&D Pipeline

  22. Slide 22: Status of R&D Pipeline

    Status of R&D Pipeline Progress in FY2021 Development code PhⅠ PhⅡ PhⅢ Application Approval/Launch KRP-R120 Completed Respiratory Approval Lyfnua (MSD, Jan 2022) Infections KRP-A 218 （Apr 2021） Launched Zymso (Apr 2021) Urology Competed AKP-009 (ASKA)※ ※ASKA started an additional Ph I study to confi

  23. Slide 23: Status of R&D Pipeline in FY2022

    Status of R&D Pipeline in FY2022 Plan in FY2022 Development code PhⅠ PhⅡ PhⅢ Application Approval/Launch KRP-R120 Completed Planning for initiating MRCT* Respiratory Launched Lyfnua tablets (Apr 2022) Infections KRP-A 218 （Apr 2021） Competed Lunched Urology AKP-009 (ASKA)※ (Apr 2022) ※Additional Ph

  24. Slide 24: Initiative toward Realization of the Long-term Vision HOPE 100

    Initiative toward Realization of the Long-term Vision “HOPE 100” 24

  25. Slide 25: Overview of Medium-Term Business Plan HOPE 100-Stage 3-

    Overview of Medium-Term Business Plan “HOPE 100-Stage 3-” Statement Realize growth trend by pursuing Kyorin’s originality ● Shift to business based on the proposal of solutions and accelerate the growth of new drug groups Business ● Enhance pipeline to support medium-term growth Strategy ● Strengthe

  26. Slide 26: Solution Provision Activities in Infection Domain

    Shift to business based on the proposal of solutions and accelerate the growth of new drug groups Solution Provision Activities in Infection Domain “Lasvic tablets“”Lasvic IV Drip Infusion Kit ” Oral antiviral drug “LAGEVRIO” (2021.1-) ・Contribute to respiratory and ENT infection along with tablets

  27. Slide 27: Expansion of product portfolios

    Shift to business based on the proposal of solutions and accelerate the growth of new drug groups Solution Provision Activities in Infection Domain Expansion of product portfolios Asthma Flutiform/Kipres Allergic rhinitis Desalex/Kipres/Nasonex COPD Eklira Infection in Lasvic respiratory/otolaryngol

  28. Slide 28: Lyfnua Tablets for refractory chronic cough

    Lyfnua® Tablets 45mg (Gefapixant citrate) for treatment of refractory chronic cough Provide option for patients as only one drug for refractory chronic cough May 2019 Memorandum of understanding on marketing collaboration Details Apr 2021 Exclusive distribution agreement in Japan Apr 2022 List on th

  29. Slide 29: Selective P2X3 Receptor Antagonist/Refractory Chronic Cough

    Selective P2X3 Receptor Antagonist/Refractory Chronic Cough Study Results of Phase 3 Study of Gafapixant (COUGH-2 Trial) ● Mode-Based Geometric Mean Ratio of 24-hour Coughs per Hour at Week 24/Baseline [Primary endpoint] 24-Hour Coughs Per Hour Geometric Mean 24-Hour Estimated Relative Cough Frequen

  30. Slide 30: Main Products' Medium-term Growth

    Shift to business based on the proposal of solutions and accelerate the growth of new drug groups Main Products’ Medium-term Growth Aculeate new drugs group in Medium-team management plan”HOPE-100-Stage 3-” Product Name Current Status (FY2021) Market Environment/Strategy Vision ICS/LABA Market ¥90bl

  31. Slide 31: Worldwide (world-class) Innovative Drug Discovery

    Strengthen drug discovery capability to realize the creation of innovative new drugs Cooperati on Watarase Research ActivX(USA) Center Open innovation Open innovation Academia Venture Pharmaceutical companies in Japan and overseas Selection and Drug Concentration discovery Kyoto with external Univer

  32. Slide 32: Promote drug discovery for fibrosis in modalities

    Strengthen drug discovery capability to realize the creation of innovative new drugs Progress of Research for Fibrosis Enhancement of drug discovery targets by collaborations with academia Progress in Department of Drug Discovery for Lung Diseases (Graduate school of Medicine, Kyoto University)  Su

  33. Slide 33: Construction of the Takaoka New Plant

    Improve cost competitiveness Reform Cost Structure by Group Optimization Construction of the Takaoka New Plant Strengthen the supply capacity as the production of drugs increased 【Outline of the Takaoka Plant】 Location IC Park 8, Takaoka-City, Toyama Site Area 42,457 m2 Building Three floors, Buildi

  34. Slide 34: Renovation the group structure

    Renovation the group structure 34

  35. Slide 35: Renovation the group structure

    Renovation the group structure Improve business promotion function and management efficiency HOPE 100 Long term vision Mid-term KYORIN-MIC-09 Management Plan Stage 1 Stage 2 Stage 3 2005～2009 2010～2015 2016～2019 2020～2023 Unique and integrated healthcare Corporate company centered on drug discovery

  36. Slide 36: Outline of Merger and Change of Trade Name

    Outline of Merger and Change of Trade Name Date of merger April 1, 2023 (Scheduled) Form of merger Absorption-type merger with KYORIN Holdings, Inc. as the surviving company and KYORIN Pharmaceutical being dissolved Effective Date to New Trade Name April 1, 2023 (Scheduled) Reason for change Shift f

  37. Slide 37: Increase the Speed

    Business strategy in FY 2022 Increase the “Speed” 37

  38. Slide 38: Disclaimer

    Disclaimer This material contains performance forecasts, goals and plans, and other forward-looking statements related to the Group. These statements are based on the judgment of the Group’s assumptions and outlooks based on the information and forecasts available at the time of preparation of this

  39. Slide 39: Kyorin ©)

    Kyorin ©)

KYORIN Holdings — FY2021 Earnings Presentation on 6ix