Kissei Pharmaceutical Co., Ltd. · TSE:4547
Kissei Pharmaceutical — Q2 FY2023 Earnings Presentation
28 slides from Kissei Pharmaceutical's earnings presentation, Nov 8, 2023
Slide 1: Financial Briefing for the Second Quarter of the Fiscal Year Ended March 31, 2024
Financial Briefing for the Second Quarter of the Fiscal Year Ended March 31, 2024 (Fiscal 2023) Yasuo Takehana President and COO November 8, 2023
Slide 2: Overview of the Financial Results for the Second Quarter of Fiscal 2023
Overview of the Financial Results for the Second Quarter of Fiscal 2023 1. Consolidated Results ✓ Net sales: ¥36,978 million (+12.5% YoY) ✓ Operating profit: ¥2,015 million ⚫ Increased sales in the Pharmaceutical Business and other businesses 2. Pharmaceutical Business ✓Net sales: ¥30,765 million (+
Slide 3: Overview of the Financial Results for the Second Quarter of Fiscal 2023 (Pipeline, Overseas)
Overview of the Financial Results for the Second Quarter of Fiscal 2023 3. Development pipeline ⚫ KORSUVA® (treatment for uremic pruritis*): New Drug Application (NDA) approved (September 2023), preparations for launch underway ⚫ Rovatirelin (treatment for spinocerebellar ataxia): NDA withdrawn, pos
Slide 4: Consolidated Financial Results for the Second Quarter of Fiscal 2023
Consolidated Financial Results for the Second Quarter of Fiscal 2023 (millions of yen) Second quarter of fiscal 2022 Second quarter of fiscal 2023 Result Ratio to sales Plan Result Ratio to net sales YoY Net sales 32,864 100.0 % 35,500 36,978 100.0 % 12.5 % [Pharmaceutical Business] [ 27,946 ] [ 85.
Slide 5: Consolidated Financial Results Compared with Fiscal 2022
Consolidated Financial Results Compared with Fiscal 2022 (Millions of yen) Source of Source of ～ Second quarter 32,864 increase decrease of fiscal 2022 Net sales (Pharmaceutical ＋2,818 Business) Increase in revenue from sales of Beova®, Pharmaceuticals ＋2,869 TAVNEOS®, and CAROGRA®, in addition to T
Slide 6: Consolidated Quarterly Profit Compared with Second Quarter of Fiscal 2022
Consolidated Quarterly Profit Attributable to Owners of Parent Compared with Second Quarter of Fiscal 2022 (Millions of yen) Source of Source of Second quarter of increase decrease fiscal 2022 3,326 ２０１５ 年 Gross profit ＋2,115 Increase in revenue, primarily in the ３月期実 Pharmaceutical Business 績 R&D e
Slide 7: Revised Plan for Fiscal 2023 (Consolidated)
Revised Plan for Fiscal 2023 (Consolidated) (millions of yen) Fiscal 2022 Fiscal 2023 Result Ratio to net sales Initial plan Revised plan Ratio to net sales YoY Net sales 67,493 100.0 % 74,500 77,500 100.0 % 14.8 % [Pharmaceutical Business] [ 56,243 ] [ 83.3 %] [ 62,500 ] [ 65,000 ] [ 83.9 %] [ 15.6
Slide 8: Pharmaceutical Business | Toward Sustainable Growth
Pharmaceutical Business｜Toward Sustainable Growth Net Sales for Pharmaceuticals*1 Growth Strategy KORSUVA® Manufacturing and marketing approval Continue to launch new products, mainly Existing products Key products products*2 New products*2 September 2023 TAVNEOS® in rare diseases Launched TAVALISSE
Slide 9: Beova | Becoming the Most-Prescribed Treatment for Overactive Bladder
Beova®｜Becoming the Most-Prescribed Treatment for Overactive Bladder Net Sales (Sales by Kissei) and Share of Patients*1 (Two Companies) Net Sales (Millions of yen) Share of patients 10,000 50% Net Sales 売上高 Share of patients 患者シェア 8,000 33% 40% Plan for fiscal 2023: 6,000 30% ¥15.8 billion (+34.0%
Slide 10: Status of Introduction of New Products to the Market
Status of Introduction of New Products to the Market｜Dealing with Intractable Diseases TAVNEOS® TAVALISSE® CAROGRA® ⚫ These drugs offer new options to patients with designated intractable autoimmune diseases who have an inadequate response to or difficulty controlling their diseases with conventiona
Slide 11: TAVNEOS | Clinical Guidelines for ANCA-Associated Vasculitis 2023
TAVNEOS®｜Clinical Guidelines for ANCA-Associated Vasculitis 2023 Treatment Regiment Options for MPA and GPA Diagnosis of MPA or GPA Assessment of organ damage and condition Cases where the risk Cases with extremely of side effects is severe renal impairment*1 considered to be high Remission inductio
Slide 12: TAVNEOS | Status of Introduction to the Market
TAVNEOS®｜Status of Introduction to the Market Net sales ⚫ June 2023: Restriction on dosage period lifted (Millions of yen) ⚫ Target patients (initial goal): Patients who 3,000 June 2023: require remission induction therapy Restriction on dosage ⚫ Number of target patients: Approx. 3,300 period lifte
Slide 13: CAROGRA | Diagnostic Criteria and Treatment Guidelines for Ulcerative Colitis
CAROGRA®｜Diagnostic Criteria and Treatment Guidelines for Ulcerative Colitis/Crohn's Disease Ulcerative Colitis Flow Chart Remission induction (treatment during active periods) Remission maintenance treatment method 1 (5-ASA) Proctitis 5-ASA administered orally and/or via enema or suppository Remiss
Slide 14: CAROGRA | Status of Market Introduction
CAROGRA®｜Status of Market Introduction Net sales (Millions of yen) 1,000 June 2023: ⚫ June 2023: Restrictions on dosage period lifted 800 Restrictions on dosage period lifted Number of Patients Treated (as of September 30, 600 2023)*1 Approx. 3,300 people June 2022: 400 Drug launch Plan for fiscal 2
Slide 15: TAVALISSE | Positioning
TAVALISSE®｜Positioning Position drug as a second-line treatment as an orally administered drug with a novel mechanism of action that inhibits platelet destruction associated with ITP H. pylori Platelet count ≥ 30 x 103/μl ＋ Observation eradication without treatment therapy No bleeding symptoms H. Py
Slide 16: TAVALISSE | Status of Introduction to the Market
TAVALISSE®｜Status of Introduction to the Market ⚫ Date of launch: April 6, 2023 ⚫ TAVALISSE® utilizes a novel mechanism of action, offering new treatment options and assistance in cases where conventional treatments prove insufficient. As a result, the number of facilities administering the drug and
Slide 17: KORSUVA | Product Overview
KORSUVA®｜Product Overview September 25, 2023: Acquired manufacturing and marketing approval in Japan Product Name KORSUVA® IV injection syringe for dialysis 17.5μg, 25.0μg, and 35.0μg Generic Name Difelikefalin acetate (JAN) Improvement of pruritus in hemodialysis patients (limited to cases in Indic
Slide 18: KORSUVA | About Uremic Pruritis in Dialysis Patients
KORSUVA®｜About Uremic Pruritis in Dialysis Patients ⚫ Approximately 70% of patients ⚫ Severe and prolonged pruritis can lead to undergoing dialysis experience pruritis, a drop in a patient’s quality of life, as well of which 30% experience severe as the following negative effects*2 pruritis.*1 • Sle
Slide 19: KORSUVA | Domestic Phase III Clinical Trial - NRS Score
KORSUVA®｜Domestic Phase III Clinical Trial ～ NRS Score ～ Design: Double-blind, placebo-controlled, multicenter, randomized, parallel-group comparative study (double-blind phase) Dosage followed by a multicenter, open-label study (continuation phase) Dry weight KORSUVA group Placebo group Participant
Slide 20: KORSUVA | Domestic Phase III Clinical Trial - Quality of Life Score
KORSUVA®｜Domestic Phase III Clinical Trial ～ Quality of Life Score ～ Total Skindex-16 Score ■ Secondary endpoint: Change in total Skindex-16 score (double-blind phase, ■ Secondary endpoint: Change in total Skindex-16 score (double-blind phase + final assessment) continuation phase) コルスバ-コルスバ群 KORSUV
Slide 21: New Drug Development (In-Company)
New Drug Development (In-Company) Development stage Product name / Phase NDA in NDA Generic name / Expected indications Development classification process approved Development code Ⅰ II III KORSUVA®/ Pruritus in hemodialysis In-licensed / Co-development Difelikefalin / patients* with Maruishi Pharma
Slide 22: New Drug Development (Out-Licensing)
New Drug Development (Out-Licensing) Development stage Generic name / Expected Countries Clinical trials Phase Preparation to NDA in NDA Partner under submit Development code indications and regions preparation Ⅰ II III application process approved company Europe Theramex Uterine fibroids China Bio
Slide 23: Improving the Quality and Speed of Drug Discovery Research through DX
Improving the Quality and Speed of Drug Discovery Research through DX Information platform Connectivity of knowledge Acquisition of Trend analysis innovative and novel drug Search for discovery targets D esign M ake Target searching and innovative verification themes The power of AI Drug Shorten com
Slide 24: Efforts to Increase Corporate Value
Efforts to Increase Corporate Value Past investments have enabled us to transition to a growth phase. We will continue investments toward stable future growth. ✓ Improve corporate value and realize a sustainable society ✓ Conduct management mindful of the cost of capital and stock price Business Str
Slide 25: 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 2023. Actual results may differ from forecasts due to risks and uncertainties that may affect business. Although drug information, including information pertaini
Slide 26: Appendix
KISSEI Appendix
Slide 27: Indicator for Assessing Improvement of Pruritis
Indicator for Assessing Improvement of Pruritis Numerical Rating Scale (NRS) Score for Itching Patients rate their itching on an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). This assessment method is based on the rating scale used widely in pain-related fields. No itch Wors
Slide 28: Quality of Life Assessment Score
Quality of Life Assessment Score Skindex-16 Score Patients reflect on their skin symptoms over the past week and complete a 16-item assessment, rating how bothered they were regarding each item on a scale of 0 (never bothered) to 6 (always bothered). Over the past week, how often did you feel bother
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