KYORIN Pharmaceutical Co.,Ltd. · TSE:4569

KYORIN Pharmaceutical Co.,Ltd — H1 FY2022 Earnings Presentation

33 slides from KYORIN Pharmaceutical Co.,Ltd's earnings presentation, Nov 10, 2022

  1. Slide 1: Interim Term Financial Results Ended September 2022

    Interim Term Financial Results Ended September 2022 November 10 , 2022 KYORIN Holdings, Inc. Representative Director, President and Chief Executive Officer Yutaka Ogihara

  2. Slide 2: Agenda

    Outline of Consolidated Financial Results Trends of mainstay products, generic product Consolidated Financial Forecast Status of R&D Pipeline Initiatives toward realization of the long-term vision “HOPE 100” 2

  3. Slide 3: Outline of Consolidated Financial Results

    Outline of Consolidated Financial Results 3

  4. Slide 4: Breakdown of Gain and Loss FY2022 2Q

    Breakdown of Gain and Loss FY2022 2Q （Units: ¥billion） Vs forecast (announced FY2021 2Q FY2022 Year-on-year on May 11, 2021) (Apr-Sep) 2Q (Apr-Sep) Change Change (%) Change Net Sales 49.1 49.1 0 －0.0 －0.5 New ethical drugs, etc. (Japan) 33.3 32.7 －0.6 －1.9 －0.7 New ethical drugs (Overseas) 0.3 0.3 0

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

    Highlights of Business Performance (1/3) YoY: Net Sales (Units: ¥billion) 【Net sales ±0 bln】 50.0 49.1 49.1 New ethical drugs, etc. (Japan) : sales deceased ―0.6 bln ●New drugs (Dezalex, Beova, Lasvic) grew 40.0 15.5 16.1 ●Decrease in sales of long-listed products (Kipres etc.) and out- licensing pr

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

    Highlights of Business Performance (2/ 3) YoY: Operating Profit (Units: ¥billion) 1 【Operation profit ＋0.9 bln】 Gross profit decreased ー0.8 bln Net sales: remain flat 0.5 0.8 Cost of sales: +1.6 percentage point <Reason of decrease> Increase in sales of main product <Reasons of increase> Impact of N

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

    Highlights of Business Performance (3/3) vs Forecast （Units: ¥billion） Year-on-year vs forecast FY2021 2Q FY2022 2Q (announced on May 11, 2022) (Apr-Sep) (Apr-Sep) Change Change (%) Change Net Sales 49.1 49.1 0 －0.0 －0.5 New ethical drugs, etc. (Japan) 33.3 32.7 －0.6 －1.9 －0.7 New ethical drugs (Ove

  8. Slide 8: FY2022 2Q Main Product Sales Update

    FY2022 2Q Main Product Sales Update （Units: ¥billion） FY2021 2Q FY2022 2Q Year-on-year vs Forecast (announced on May 22, 2022) (Apr-Sep) (Apr-Sep) Change Change (%) Change Flutiform (Combination drug for asthma treatment) 6.3 5.7 －0.6 －8.9 ＋0.1 Desalex (Antiallergic Agent) 2.6 3.0 ＋0.4 ＋14.9 ＋0.1 Be

  9. Slide 9: Trends of Mainstay Products and Generic Drugs

    Trends of Mainstay Products and Generic Drugs 9

  10. Slide 10: Flutiform (Anti-asthmatic)

    Flutiform（Anti-asthmatic） ICS/LABA market Flutiform share Sales Second half First half （Units: ¥billion） (Apr-Sep) （Units: %） （Units: ¥billion） 60.0 20 15 14.6 13.1 13.3 15.8 15.8 12.6 12.0 15.2 15 12.6 7.9 40.0 11.9 10 7.0 6.9 6.3 6.3 60.8 10 56.7 51.1 45.7 41.8 20.0 5 5 6.1 6.7 6.4 6.3 5.7 5.6 (Fo

  11. Slide 11: Desalex (Antiallergic Agent)

    Desalex (Antiallergic Agent) Antihistamine market (Apr-Sep) Second half Sales First half （Units: ¥billion） New drugs Desalex share （Units: ¥billion） 80.0 10.0 10 9.0 7.4 8.0 8.0 60.0 8 7.1 7.0 5.9 Supply suspended : 5.2 6.0 6 about 10 months 5.7 68.4 5.0 40.0 4.1 5.0 4.5 4.0 3.7 55.9 4 3.9 66.1 52.3

  12. Slide 12: Beova (OAB)

    Beova (OAB) OAB market (Apr-Sep) Sales Second half First half （Units: ¥billion） （Units: ¥billion） Beova(KYORIN) share (%) 50 20 15 14.1 40 14.8 47.3 15 48.5 10 8.6 8.6 30 44.3 46.6 9.2 7.3 8.9 10 4.3 20 43.8 3.5 5 4.3 6.4 1.8 5 5.5 (Forecast) 10 0.7 3.7 4.3 3.8 0 0.7 0.6 0 0 19/3 20/3 21/3 22/3 23/3

  13. Slide 13: End of Restrictions on Shipment: August 2022 Aim to No.1 in Market of OAB

    End of restrictions on shipment End of Restrictions on Shipment: August 2022 Statue of Beova in market of OAB ● Number of new costumers expand as our plan ● Achieved No.1*1 for rate of acquiring prescriptions in new patients ● Expansion of market share for forecast sales proceed as expected Decrease

  14. Slide 14: Lasvic (New quinolone synthetic antibacterial agent)

    Lasvic (New quinolone synthetic antibacterial agent) Oral antimicrobial market(Apr-Sep) Lasvic share Sales Second half First half （Units: ¥billion） (%) 3.0 60.0 5 3 4 3.3 40.0 2 1.8 2.0 2.7 3 31.3 50.4 48.7 28.9 2 1.1 1.0 20.0 1.4 0.9 1 30.7 1 1.1 0.7 1.0 1.3 0.8 (Forecast) 0.0 0 0 0.2 19/3 20/3 21/

  15. Slide 15: Status of Generic Drugs

    Status of Generic Drugs Sales in GE Second half Sales in AG (three products) among with the sales at left Second half First half First half （Units: ¥billion） 40 36.7 20 34.8 32.2 16.6 31.0 15.4 14.8 29.3 14.3 30 15 20.6 11.9 19.3 16.8 17.8 10.1 15.7 9.7 7.9 20 10 8.5 6.6 10 15.8 5 16.1 (Forecast) 5.

  16. Slide 16: Consolidated Financial Forecast FY2022

    Consolidated Financial Forecast FY2022 16

  17. Slide 17: 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.

  18. Slide 18: Forecast of Mainstay Products Sales

    Forecast of Mainstay Products Sales (Unit: ¥billion) FY2022 Year-on-year FY2021 (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

  19. Slide 19: 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 FY2020 FY2021 (Forec

  20. Slide 20: Status of R&D Pipeline

    Kyorin ©) | Status of R&D Pipeline

  21. Slide 21: Plan of R&D Pipeline in FY2022

    Plan of R&D Pipeline in FY2022 As of May 11, 2022 Development code Ph1 Ph2 Ph3 Application Approval/Launch Launched Lyfnua tablets (Apr 2022) Respiratory KRP-R120 Planning for initiating MRCT ※1 Infections KRP-A218 （April 2021) Urology AKP-009※2 ※1 MRCT: Multi-Regional Clinical Trials Plan in FY2022

  22. Slide 22: Status of R&D Pipeline in FY2022

    Status of R&D Pipeline in FY2022 As of Nov 9, 2022 Development code Ph1 Ph2 Ph3 Application Approval/Launch Launched Lyfnua tablets (Apr 2022) Respiratory KRP-R120※1 Sep 2022 Infections KRP-A218 （April 2021) ※2 AKP-009 Urology KRP-114VP Aug 2022 ※1 Ph1b/2a study has been completed in USA (aTyr) ※2 A

  23. Slide 23: Multi-Regional Clinical Trials (Phase 3 study)

    Pulmonary Sarcoidosis treatment [KRP-R120(Efzofitimod)] ●Multi-Regional Clinical Trials (Phase 3 study) Titles Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis Study Design Randomized, Double-Blind, Placebo-Controlled Parallel Assignment Study Outcome [Primary Out

  24. Slide 24: GMAC (Genetically Modified Adipocyte)

    GMAC（Genetically Modified Adipocyte) 1.Excision of Status 2.Isolation of Patients Subcutaneous Adipocytes 3.GMAC Preparation adipose tissue Joint development and license agreement /Gene transfer with CellGenTech (June 2022) Non-clinilcal study is ongoing Patients 5.Administration of GMAC 4.Expansion

  25. Slide 25: Initiative toward Realization of the Long-term Vision HOPE 100

    Initiative toward Realization of the Long-term Vision “HOPE 100” 25

  26. Slide 26: Realize growth trend by pursuing Kyorin's originality

    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

  27. Slide 27: 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” (2022.1-) ・Contribute to respiratory and ENT infection along with tablets

  28. Slide 28: Lyfnua Tablets 45 mg

    Shift to business based on the proposal of solutions and accelerate the growth of new drug groups Accelerate the growth of new drug groups Treatment of chronic cough Lyfnua Tablets 45 mg Launch: April 21, 2022 Status in FY2022 2Q ⚫ Enhancement of better understanding for product characteristic to re

  29. Slide 29: Development of Digital Therapeutics in Otolaryngology Field

    Enhance pipeline to support medium-term growth Development of Digital Therapeutics in Otolaryngology Field Background Expand product portfolio including new treatment option for strengthen competitiveness in otolaryngology area, aiming "Establish strong presence in priority area (respiratory, otolar

  30. Slide 30: Start of Construction of the Takaoka New Plant

    Improve cost competitiveness Reform Cost Structure by Group Optimization Start of 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 floor

  31. Slide 31: Increase the Speed

    Business strategy in FY 2022 Increase the “Speed” 31

  32. Slide 32: 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

  33. Slide 33: Kyorin ©)

    Kyorin ©)

KYORIN Holdings — H1 FY2022 Earnings Presentation on 6ix