Kissei Pharmaceutical Co., Ltd. · TSE:4547
Kissei Pharmaceutical — FY2022 Earnings Presentation
24 slides from Kissei Pharmaceutical's earnings presentation, May 10, 2023
Slide 1: Financial Briefing for the Fiscal Year Ended March 31, 2023 (Fiscal 2022)
Financial Briefing for the Fiscal Year Ended March 31, 2023 (Fiscal 2022) Yasuo Takehana President and COO May 10, 2023
Slide 2: Summary of Financial Results for Fiscal 2022
Summary of Financial Results for Fiscal 2022 1. Consolidated results ✓ Plan for fiscal 2022: Operating profit ¥500 million ⇒ Result: Operating loss ¥1,129 million ⚫ Revenue from technical fees deferred to the following fiscal year ⚫ Net sales for the Pharmaceutical Business did not reach target; cos
Slide 3: Consolidated Financial Results for Fiscal 2022
Consolidated Financial Results for Fiscal 2022 (millions of yen) Fiscal 2021 Fiscal 2022 Result Ratio to net sales Forecast Result Ratio to net sales YoY Net sales 65,381 100.0% 68,500 67,493 100.0% 3.2% [Pharmaceutical Business] [54,147] [82.8%] [57,500] [56,243] [83.3%] [3.9%] *1 Pharmaceuticals 4
Slide 4: Consolidated Financial Results Compared with Fiscal 2021
Consolidated Financial Results Compared with Fiscal 2021 Source of Source of (Millions of yen) increase decrease Fiscal 2021 ～ 65,381 Net sales ＋2,096 (Pharmaceutical Business) ・Increase due to launch of CAROGRA® and Pharmaceuticals*1 ＋1,285 TAVNEOS®, and increased sales of Beova® Breakdown of chang
Slide 5: Breakdown of Consolidated Profit Attributable to Owners of Parent Compared with Fiscal 2021
Consolidated Profit Attributable to Owners of Parent Compared with Fiscal 2021 Source of Source of (Millions of yen) increase decrease Fiscal 2021 12,921 ２０１５ ・Increase due to an increase in 年Gross profit ＋1,136 revenue in the Pharmaceutical ３月期実 Business 績R&D expenses －28 Breakdown of Other SG&A ・I
Slide 6: Plan for Fiscal 2023 (Consolidated)
Plan for Fiscal 2023 (Consolidated) (millions of yen) Fiscal 2022 Fiscal 2023 Forecast Ratio to net Ratio to net Result Full year YoY First half sales sales Net sales 67,493 100.0% 74,500 100.0% 10.4% 35,500 [Pharmaceutical Business] [56,243] [83.3%] [62,500] [83.9%] [11.1%] [29,500] Pharmaceutical
Slide 7: Outlook for the Pharmaceutical Business
Outlook for the Pharmaceutical Business PEGASUS FY2018 FY2019 FY2020 FY2021 FY2022 FY2023 FY2024 (Pharmaceutical Business) Urief® patent cliff ＜New overseas Net Sales earnings＞ ●Linzagolix ＜New products＞ ●CAROGRA® (launched in May 2022) ＜Major existing products＞ ●TAVNEOS® (launched in June 2022) ●Be
Slide 8: Beova: Becoming the Most-Prescribed Treatment for Overactive Bladder
Beova®: Becoming the Most-Prescribed Treatment for Overactive Bladder (millions Net Sales of Beova ® (Sales by Kissei) and of yen) Share of Patients (Two Companies) 10,000 50% Sales Share of patients *1 8,000 40% 28.9% 28.9% 6,000 30% 4,000 20% 2,000 10% Sales forecast 0 0% for fiscal 2023: Period 下
Slide 9: Urology Area Strategy
Urology Area Strategy Spreading ▶ Promote awareness of urology conditions through public lectures, websites, and materials awareness for patients Provision of ▶ Propose appropriate treatments for three conditions and communicate benefits to patients Information ▶ Kissei’s medical representatives (MR
Slide 10: CAROGRA: Diagnostic Criteria and Treatment Guidelines for Ulcerative Colitis/Crohn's Disease
CAROGRA®: Diagnostic Criteria and Treatment Guidelines for Ulcerative Colitis/Crohn's Disease Ulcerative Colitis Flow Chart Remission induction (treatment during active periods) Remission maintenance Proctitis treatment method 1 (5-ASA) 5-ASA administered orally and/or via enema or suppository Remis
Slide 11: TAVNEOS: Positioning
TAVNEOS®: Positioning Provide a new option to treat ANCA-associated vasculitis as the standard alternative to steroids Post-launch period Future Positioning in accordance with ADVOCATE trial Work with medical experts to build product based evidence on post-launch evidence TAVNEOS® + immunosuppressiv
Slide 12: TAVNEOS: Current Status and Outlook
TAVNEOS®: Current Status and Outlook Provide a new option to treat ANCA-associated vasculitis as the standard alternative to steroids Net sales (millions of yen) Estimated Number of Patients Treated*1 2,000 Approx. 580 1,500 Drug 1,000 launched June 2022 Prescriptions*2 500 About 80% remission induc
Slide 13: TAVALISSE: Overview
TAVALISSE®: Overview Date of launch: April 6, 2023 Indications Drug Price Chronic idiopathic thrombocytopenic purpura (ITP*1) ¥4,188.0 per tablet (100 mg), ¥6,226.8 per tablet (150 mg) Dosage and Administration Typical initial adult dosage of fostamatinib is 100mg administered orally twice a day. If
Slide 14: TAVALISSE: Clinical Trial Results
TAVALISSE®: Clinical Trial Results Results of domestic Phase III clinical trial (R788-1301) First Period (Double-Blind Test) Stable platelet response*1 Platelet Count for Responders*2 and Non-Responders (Primary endpoint) (Subgroup Analysis of Secondary Endpoint) (%) 100 Δ Group difference Responder
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 without Sales forecast for treatment fiscal 2023: eradicatio No
Slide 16: Introduce New Products to the Market, Focusing on Rare Diseases
Introduce New Products to the Market, Focusing on Rare Diseases TAVNEOS® TAVALISSE® Smooth provision of new drugs to medical sites through collaboration between the Rare Diseases Project* and MRs * A department responsible for planning marketing strategies in the rare disease area, collecting inform
Slide 17: New Drug Development (In-Company)
New Drug Development (In-Company) Development stage Generic name / Phase NDA in Development Development Expected indications code I II III process classification Rovatirelin / Spinocerebellar ataxia In-licensed / Shionogi KPS-0373 In-licensed / Co- Difelikefalin / Pruritus in development with MR13A9
Slide 18: Difelikefalin: Overview
Difelikefalin: Overview ◆ 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 development: Primary endpoint achieved in
Slide 19: Difelikefalin: Clinical Trial Results
Difelikefalin: Clinical Trial Results Domestic Phase II clinical trial Pre- Eight-week double-blind Follow-up Design: Placebo-controlled double-blind comparative study screening treatment period Participants: Hemodialysis patients with previously treated pruritus*1 Placebo Dosages: Difelikefalin (0.
Slide 20: New Drug Development (Out-Licensing)
New Drug Development (Out-Licensing) Development stage Generic name / Phase Expected Countries Clinical trials Preparation to NDA in NDA Development under submit Partner company indications and regions preparation I II III application process approved code Europe Theramex Uterine China Bio Genuine f
Slide 21: Enhance Drug Discovery Research
Enhance Drug Discovery Research What: Commitment to the concept of drug discovery ➢ Modality: Focus on small molecule drug discovery Expand development pipeline ➢ Targets: Find targets that leverage the advantages of small molecules ➢ Mechanism of action: Discover unprecedented new use cases In-lice
Slide 22: Basic Policy on the Distribution of Profits
Basic Policy on the Distribution of Profits ◆ Financial Strategy Regarding profit attributable to owners of parent, our goal is to achieve an ROE of 5.0% or higher. We will secure net income through the effective use of cross-shareholdings and other financial assets and actively expand and bolster c
Slide 23: Corporate Governance Bodies and Internal Control System
Corporate Governance Bodies and Internal Control System General Meeting of Shareholders Election / Dismissal Election / Dismissal Election / Dismissal Consult Board of Directors Nomination and Audit (12 Members, including Compensation 4 Outside Directors) Deliberation Committee Audit & Supervisory B
Slide 24: 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 May 2023. Actual results may differ from forecasts due to risks and uncertainties that may affect business. Although drug information, including information pertaining to