Kissei Pharmaceutical Co., Ltd. · TSE:4547

Kissei Pharmaceutical — Q2 FY2022 Earnings Presentation

20 slides from Kissei Pharmaceutical's earnings presentation, Nov 9, 2022

  1. Slide 1: Financial Briefing for the Second Quarter of the Fiscal Year Ended March 31, 2023

    Financial Briefing for the Second Quarter of the Fiscal Year Ended March 31, 2023 (Fiscal 2022) Yasuo Takehana President and COO November 9, 2022

  2. Slide 2: Overview of the Fiscal 2022

    Overview of the Fiscal 2022 1. Increase domestic sales ✓ Launched two new drug products in Japan ⚫ May 2022: Launched alpha-4 integrin antagonist CAROGRA®, a treatment for ulcerative colitis ⚫ June 2022: Launched selective complement C5a receptor antagonist TAVNEOS®, a treatment for microscopic poly

  3. Slide 3: Consolidated Financial Results for the Second Quarter of Fiscal 2022

    Consolidated Financial Results for the Second Quarter of Fiscal 2022 Total for the first half of fiscal 2021 Total for the first half of fiscal 2022 (April 2021–September 2021) (April 2022–September 2022) Year on year Amount Plan Result Ratio to net sales Ratio to net sales (millions of yen) (millio

  4. Slide 4: Consolidated Net Sales Compared with the Second Quarter of Fiscal 2021

    Consolidated Net Sales Compared with the Second Quarter of Fiscal 2021 Source of Source of (Millions of yen) increase decrease Net sales during the second quarter of fiscal 2021 ~32,388 Net sales (Pharmaceutical +978 Business) Increase in sales of Beova®, Darbepoetin Alfa and Pharmaceuticals +603 ot

  5. Slide 5: Breakdown of Consolidated Quarterly Profit Attributable to Owners of Parent

    Consolidated Quarterly Profit Attributable to Owners of Parent Compared with Second Quarter of Fiscal 2021 Source of Source of (Millions of yen) increase decrease Quarterly profit during the second 5,666 quarter of fiscal 2021 Increase in profit due to higher sales and Gross profit +721 decrease in

  6. Slide 6: Revised Plan for Fiscal 2022 (Consolidated)

    Revised Plan for Fiscal 2022 (Consolidated) Fiscal 2021 results Fiscal 2022 plan Year on year Amount Initial plan Revised plan Ratio to net sales Ratio to net sales (millions of yen) (millions of yen) (millions of yen) Net sales 65,381 100.0% 68,000 68,500 100.0% 4.8% [Pharmaceutical Business] [ 54,

  7. Slide 7: Clinical Guidelines for Overactive Bladder Syndrome: Beova

    Treatment for overactive bladder Beova® Clinical Guidelines for Overactive Bladder Syndrome: Beova® Third edition of Clinical Guidelines for Overactive Bladder Syndrome (issued September 2022): Vibegron (Beova®) listed as a Grade A recommended treatment for overactive bladder (Other Grade A recommen

  8. Slide 8: Sales of Beova

    Treatment for overactive bladder Beova® Sales of Beova® Position Beova® as a beta-3 agonist with high efficacy and safety and the No. 1 treatment for overactive bladder Half-year net sales for Beova® (based on financial results) Millions of yen 8,000 Sales forecast for fiscal 2022: ¥12.0 billion (+4

  9. Slide 9: Product Overview: TAVNEOS

    Treatment for microscopic polyangiitis and granulomatosis with polyangiitis TAVNEOS® Product Overview: TAVNEOS® Date of launch: June 7, 2022 Indications Microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA) Dosage and Administration Typical adult dosage is 30 mg twice daily orall

  10. Slide 10: Status of Activities: TAVNEOS

    Treatment for microscopic polyangiitis and granulomatosis with polyangiitis TAVNEOS® Status of Activities: TAVNEOS® Provide a new option to treat ANCA-associated vasculitis as the standard alternative to steroids 【Positioning】 Sales forecast for fiscal Positioning in accordance with Work with medica

  11. Slide 11: Product Overview: CAROGRA

    Treatment for ulcerative colitis CAROGRA® Product Overview: CAROGRA® Date of launch: May 30, 2022 Indications Moderate ulcerative colitis (limited to those patients who had inadequate response to 5- aminosalicylic acid (5-ASA)) Dosage and Administration Typical adult dosage of carotegrast methyl is

  12. Slide 12: Status of Activities: CAROGRA

    Treatment for ulcerative colitis CAROGRA® Status of Activities: CAROGRA® Position CAROGRA® as the first choice for patients with an inadequate response to orally administered 5-ASA 【Positioning】 Sales forecast for fiscal Surgery 2022: ¥0.6 billion Fulminant Intractable Severe Intravenous feeding, st

  13. Slide 13: New Drug Development (In-Company)

    New Drug Development (In-Company) Changes from May 2022 12

  14. Slide 14: New Drug Development (Out-Licensing)

    New Drug Development (Out-Licensing) Changes from May 2022 13

  15. Slide 15: Fostamatinib

    Small molecule tyrosine kinase (SYK)*1 inhibitor Fostamatinib Expected indication: Chronic idiopathic thrombocytopenic purpura (ITP)*2 ⚫ Acquired development and marketing rights in Japan, China, South Korea, and Taiwan from U.S.- based Rigel Pharmaceuticals, Inc., in October 2018, and submitted NDA

  16. Slide 16: Difelikefalin (Generic Name)

    Treatment for uremic pruritis Difelikefalin (Generic Name) Expected indication: Pruritus in hemodialysis patients (improvement of symptoms when existing treatments are inadequate) ⚫ Licenser: Maruishi Pharmaceutical Co., Ltd. (via Cara Therapeutics, Inc., originator of the drug) ⚫ Domestic developme

  17. Slide 17: Promoting the Basic Strategies of PEGASUS

    Promoting the Basic Strategies of “PEGASUS” Increase Domestic Sales, Strengthen Our Overseas Earnings Base Domestic: Continued introduction of new Overseas: Launch Kissei- drugs in key areas developed drugs globally < Domestic available-for-sale <Domestic development> <Overseas expansion> pharmaceut

  18. Slide 18: Enhance Drug Discovery Research

    Promoting the Basic Strategies of “PEGASUS” Enhance Drug Discovery Research What: Commitment to the concept of drug discovery Creation of innovative new drugs that ➢ Modality: Focus on small molecule drug discovery ➢ Targets: Find targets that leverage the advantages of small molecules ➢ Mechanism o

  19. Slide 19: Strengthen Our Management Base, Contribute to the SDGs

    Promoting the Basic Strategies of “PEGASUS” Strengthen Our Management Base, Contribute to the SDGs Using Our Material Issues <Management Philosophy> Contribute to society through high-quality, innovative pharmaceutical products Serve society through our employees Value created Kissei’s business acti

  20. Slide 20: Forward-looking statements notice

    The forward-looking statements in these materials are based on Kissei's analysis of existing information and various trends as of November 2022. Actual results may differ from forecasts due to risks and uncertainties that may affect business. Although drug information, including information pertaini

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