Shionogi & Co., Ltd. · TSE:4507
Shionogi & — Q3 2024 Earnings Presentation
33 slides from Shionogi &'s earnings presentation, Jan 31, 2025
Slide 1: 3rd Quarter of Fiscal 2024 Financial Results
3rd Quarter of Fiscal 2024 Financial Results January 31, 2025 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda 01 Overview of Q3 FY2024 Financial Results （P.3-12） 02 Towards the Realization of the 2030 Vision （P.13-26） ・Transformation of Chinese Business ・Pipeline Progress 2
Slide 3: Overview of Q3 FY2024 Financial Results
Overview of Q3 FY2024 Financial Results 3
Slide 4: Highlight
Highlight Excluding the one-time payment* from last year, both the top line and operating profit have increased Operating Topline profit 336.8 B yen 333.6 B yen 138.7 B yen 129.2 B yen (Excludes one-time payment ) (311.8 B yen) (Excludes one-time payment ) (113.7 B yen) (Unit: Byen) (Unit: Byen) tra
Slide 5: Financial Results
Financial Results • Sales revenue and various profit items landed almost as expected against the full-year forecast ‒ The HIV business and overseas business continue to grow strongly Summary ‒ Domestic business is making steady progress due to the stabilization of the infectious disease business. •
Slide 6: Statement of Profit or Loss
Statement of Profit or Loss （Unit：B yen） FY2024 FY2023 Y on Y Main Variation Factors (Y on Y) Forecast Apr.-Dec. Achievement Apr.-Dec. Change (%) Change Full year Results (%) Results Revenue 460.0 333.6 72.5 336.8 (1.0) (3.2) Revenue • Overseas subsidiaries /export 14.6 13.8 12.6 Increase Cost of Sa
Slide 7: Revenue by Segment
Revenue by Segment (Unit：B yen) FY2024 FY2023 Y on Y Main variation Factors (Y on Y) Forecast Full Apr.-Dec. Achievement Apr.-Dec. Change (%) Change year Results (%) Results Prescription drugs Prescription drugs 124.7 78.9 63.3 127.5 (38.1) (48.6) • Sales of Infectious disease Excluding temporary in
Slide 8: Prescription Drugs in Japan
Prescription Drugs in Japan （Unit：B yen） FY2024 FY2023 Y on Y Forecast Achievement Apr.-Dec. Results Apr.-Dec. Results Change (%) Change Full year (%) Infectious disease drugs 83.4 50.0 60.0 69.0 (27.5) (19.0) COVID-19 related products ＋ Influenza franchise 72.3 43.3 59.9 62.0 (30.2) (18.7) Symproic
Slide 9: Expansion of the HIV Business
Expansion of the HIV Business Continued stable growth each quarter, centered on the growth of oral two drug regimens* and LA formulations*2 Transition of SHIONOGI's HIV royalty income Sales of ViiV’s dolutegravir and cabotegravir products*3 (quarterly) +12.3 B yen (M￡) 800 80 1,800 600 60 1,500 Triu
Slide 10: Expansion of Overseas Business
Expansion of Overseas Business With the stable growth of Cefiderocol in Europe and the United States and the expansion of the countries where it is sold, the overseas business is poised for further growth Sales revenue of overseas 海外子会社/輸出の売上収益（四半期ごと） subsidiaries/exports (quarterly) +1.4 B yen 15 1
Slide 11: Status of Domestic Business (Influenza and COVID-19)
Status of Domestic Business (Influenza and COVID-19) In the market for influenza and COVID-19 treatments, we aim to expand our market share and contribute to stable performance in response to the epidemics Patient trends* (From Apr. 4th week of 2023) Influenza Family*2 (Influenza treatment) (people)
Slide 12: Results for Q3 of FY2024
Results for Q3 of FY2024 The growth of the HIV business and overseas business, along with the stabilization of the domestic business, is expected to achieve the full-year forecast The HIV business and overseas business have • HIV business: +37.4 billion yen (Y on Y) grown significantly • Overseas bu
Slide 13: Towards the Realization of the 2030 Vision
Towards the Realization of the 2030 Vision ・Transformation of the China Business ・Pipeline Progress 13
Slide 14: Dissolution of Joint Venture With Ping An Insurance
Dissolution of Joint Venture With Ping An Insurance SHIONOGI will independently expand its business in China and the broader Asia region Achievements of the joint venture and the structure Future Framework • Submission for approval of cefiderocol in China and its early use • SHIONOGI will fully acqu
Slide 15: Future Outlook for the China Business
Future Outlook for the China Business Achieving growth in China by focusing on the new drug business • Accelerating the launch of SHIONOGI products and advancing new drug discovery in China • Driving top-line growth through the continuous launch of new drugs starting in FY2025 Launch of SHIONOGI Pro
Slide 16: Towards the Realization of the 2030 Vision
Towards the Realization of the 2030 Vision ・Transformation of the China Business ・Pipeline Progress 16
Slide 17: Acute Respiratory Infections Business: Diversification of Portfolio
Acute Respiratory Infections Business：Diversification of Portfolio Expansion of the disease portfolio and globalization of each drug, moving from "stabilization" to "growth" Influenza Completion of treatment and Xofluza prevention with a single oral dose • Accumulation of new evidence to suppress vi
Slide 18: COVID-19: Global Market Potential
COVID-19: Global Market Potential COVID-19 continues to mutate and affects the health and lives of many people around the world Estimated number of patients in US* Total sales of two oral therapeutic products in US*2 from September 29, 2024, to January 4, 2025 from January to September 2024 ーCOVID-1
Slide 19: Ensitrelvir: Positive Results From the SCORPIO-PEP Trial
Ensitrelvir: Positive Results From the SCORPIO-PEP* Trial Demonstrated the world's first preventive effect against the onset of COVID-19 with an oral antiviral drug*2 Trial design*3 Preliminary trial results Country US, South America, Africa, Asia including Japan Trial Design Multicenter, randomized
Slide 20: Ensitrelvir: Pediatric Trial Results in Japan
Ensitrelvir: Pediatric Trial Results in Japan Promote development for expanded indications targeting pediatric patients aged 6 to under 12 years with limited treatment options Trial design* Preliminary trial results Country Japan • Confirmed safety and tolerability Trial Design Results Multicenter,
Slide 21: Ensitrelvir: Status of Global Development
Ensitrelvir: Status of Global Development Promoting various initiatives to maximize the value of ensitrelvir, including expanding indications and global deployment Development status Status of applications to various countries/regions Clinical trial Status Countries/region Status SCORPIO-SR Achieved
Slide 22: S-892216: Investigational Second Generation 3CL Protease Inhibitor
S-892216: Investigational Second Generation 3CL Protease Inhibitor Accelerating the development of new solutions to address significant public health challenges S-892216 Profile S-892216 Development plan Mechanism of action Oral pill* • SARS-CoV-2 3CL protease inhibition • Indications: COVID-19 Trea
Slide 23: S-337395: Market Potential and Mechanism (RS virus infection)
S-337395：Market Potential and Mechanism (RS virus infection) A market with significant unmet medical needs due to the lack of effective treatments despite a large number of potential patients Potential Patient Numbers in the US*1,2 Mechanism of S-337395*3 Infants and young children High-risk patient
Slide 24: S-337395: Top-Line Result in Phase 2 Trial
S-337395：Top-Line Result in Phase 2 Trial* In the Phase 2 trial, a statistically significant reduction in viral load was confirmed Trial Design Preliminary Trial Results Country United Kingdom -Achieved primary endpoints- Randomized, placebo-controlled, double- • In the highest dose group, there was
Slide 25: Progress of Major Development Products - Infection diseases
Progress of Major Development Products - Infection diseases - ※ The bar starts from FPI and ends at CSR, Topline results: It is the timing of acquisition, and the timing of disclosure will be considered separately Disease area Pipeline Indication Current stage FY2024 FY2025 Note Preparation for Ensi
Slide 26: Progress of Major Development Products - QOL Diseases with High Social Impact
Progress of Major Development Products - QOL Diseases with High Social Impact - ※ The bar starts from FPI and ends at CSR, Topline results: It is the timing of acquisition, and the timing of disclosure will be considered separately Disease area Pipeline Indication Current stage FY2024 FY2025 Note SD
Slide 27: Appendix
Appendix 27 @® sionoai
Slide 28: Zatolmilast: Development Targeting Jordan Syndrome
Zatolmilast: Development Targeting Jordan Syndrome Initiating clinical trials targeting Jordan syndrome, aiming to develop the world's first treatment What is Jordan Syndrome? Features and Development Plan of Zatolmilast The world’s first treatment to address existing unmet medical needs • Mechanism
Slide 29: Pipeline: Infectious Disease
Pipeline: Infectious Disease as of January 31, 2025 Preclinical Phase 1 Phase 2 Phase 3 Submission S-567123 S-337395 S-337395 Cefiderocol Ensitrelvir* Ensitrelvir*2 COVID-19 Aerobic Gram-negative RSV infections RSV infections COVID-19 treatment COVID-19 treatment Universal vaccine bacterial infectio
Slide 30: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of January 31, 2025 Preclinical Phase 1 Phase 2 Phase 3 Submission Resiniferatoxin SDT-001 S-540956 S-151128 S-309309 Redasemtide*3 [GRT7039] ADHD Nucleic acid adjuvant Chronic pain Obesity Acute ischemic stroke Pain associated with knee osteoarthrit
Slide 31: Anti-HIV drug released by ViiV
Anti-HIV drug released by ViiV Product CY2023 Formulations Compounds Administrations Frequency Indications name Sales (M￡) Cabenuva CAB＋RPV IM injection Q2M (LA) Treatment 708 Long Acting Apretude CAB IM injection Q2M (LA) PrEP 149 Dovato DTG＋3TC Oral Every day Treatment 1,819 Two-drug regimens Julu
Slide 32: Other Major Progress
Other Major Progress* • October - Disclosure of Materials on Measures to Achieve Management that Considers Capital Costs and Stock Prices ٠ December - Integrated Report 2024 Wins Bronze Award (Honorable Mention) at the WICI Japan Integrated Report Awards 2024 • January - AdvanSentinel Inc. has launc
Slide 33: Forward-Looking Statements
Forward-Looking Statements • Forecast or target figures in this material are neither official forecasts of earnings and dividends nor guarantee of target, achievement and forecasts, but present the midterm strategies, goals and visions. Official earnings guidance should be referred to in the disclos