Shionogi & Co., Ltd. · TSE:4507
Shionogi & — FY2024 Earnings Presentation
59 slides from Shionogi &'s earnings presentation, May 12, 2025
Slide 1: Fiscal 2024 Financial Results
Fiscal 2024 Financial Results May 12, 2025 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda 01 Overview of FY2024 Financial Results （P.3-13） 02 Main Activities of STS2030 Revision Phase 2 （P.14-32） Changes to STS2030 Revision Phase 2 KPIs Business investments aimed at new growth Growth of Existing Business Progress in pipeline 03 FY2025 Financial Forecasts and Shareholder Re
Slide 3: Overview of FY2024 Financial Results
Overview of FY2024 Financial Results 3
Slide 4: Highlight
Highlight Revenue and operating profit have reached a record high for the third consecutive term Topline (B yen) Operating profit (B yen) Summary of FY2024 Financial Results Compared to the + 3.2 + 3.3 previous year • Absorbed the impact of last year’s one-time payment*1 (25 billion yen) and achieve
Slide 5: Statement of Profit or Loss
Variation Factors Statement of Profit or Loss （Y on Y） （Unit: B yen） FY2024 FY2023 Y on Y 3.2 (6.2) Forecast Achieveme Change (2.7) Results Results Change 15.0 Full year nt(%) (%) (6.0) Revenue 460.0 438.3 95.3 435.1 0.7 3.2 14.6 14.6 13.2 Cost of Sales 153.3 156.6 67.0 63.8 95.3 57.6 10.8 6.2 Gross
Slide 6: Details of Cost Increases (Y on Y)
Details of Cost Increases (Y on Y) Cost of sales Major cost increases (Y on Y) • From FY2022 onwards, we have increased production and 2.6% 5.8% made investments in facilities in response to the expanding 1200 120 increase increase demand for antibiotics and other products ⇒The cost in relative term
Slide 7: Revenue by Segment
Variation Factors （Y on Y） Revenue by Segment （Unit: B yen） 0.2 FY2024 FY2023 Y on Y Forecast Achieveme Results Results Change(%) Change Full year nt(%) (52.4) 44.3 Prescription drugs 124.7 98.8 79.2 151.1 (34.6) (52.4) Excluding temporary include income - 98.8 - 126.1 (21.7) (27.3) one-time payment
Slide 8: Prescription Drugs in Japan
Prescription Drugs in Japan （Unit: B yen） FY2024 FY2023 Y on Y Forecast Results Achievement(%) Results Change(%) Change Full year Infectious disease drugs 83.4 61.4 73.6 82.9 (26.0) (21.6) COVID-19 related products ＋ Influenza franchise 72.3 51.8 71.6 73.4 (29.5) (21.6) Symproic 5.9 5.0 85.1 4.5 11.
Slide 9: Progress of HIV Business by ViiV (FY2024)
Progress of HIV Business by ViiV（FY2024） The HIV business is experiencing strong growth due to the expansion of the oral two drug regimens*1 and LA*2 formulations Sales of ViiV’s HIV products*3 Transition of SHIONOGI's HIV royalty income*4 7,500 3,000 300 Oral two-drug regimens and LA formulations h
Slide 10: Progress of Overseas Business (FY2024)
Progress of Overseas Business (FY2024) The overseas business has achieved a record high for the fourth consecutive term, due to the stable growth of cefiderocol Revenue of overseas subsidiaries/exports Summary of FY2024 700 70 Global expansion of cefiderocol An average annual growth 600 60 rate of25
Slide 11: Progress of Domestic Business (FY2024)
Progress of Domestic Business (FY2024) With two infectious disease drug assets, the acute respiratory infection business contributes steadily to performance throughout the year Sales trends of acute respiratory infections business on a semiannual basis (over 4 years) 50 500 One infectious disease dr
Slide 12: Progress of Main Pipelines for the Current Fiscal Year (FY2024)
Progress of Main Pipelines for the Current Fiscal Year (FY2024) Multiple pipelines are making steady progress, achieving various approvals and submissions for approval Infection diseases QOL diseases with high social impact S-268019 Approved in Japan ENDEAVORRIDE Approved in Japan COVID-19 vaccine A
Slide 13: Results for FY2024
Results for FY2024 Achieved growth surpassing last year‘s one-time payment (25B yen) and achieved increased revenue and operating profit The topline and operating profit has • HIV Business +44.6B yen（Y on Y +22.8%） reached a record high • Overseas Business +9.2B yen（Y on Y +18.4%） • Implemented stri
Slide 14: Main Activities of STS2030 Revision Phase 2
Main Activities of STS2030 Revision Phase 2 Changes to STS2030 Revision Phase 2 KPIs Business investments aimed at new growth Growth of existing business Progress in pipeline 14
Slide 15: Changes to KPIs in STS2030 Revision Phase 2
Changes to KPIs in "STS2030 Revision Phase 2" Although the main KPIs of STS2030 Revision Phase 2 have been revised downward, FY2025 will be a year of significant growth FY2024 FY2025 FY2025 Results Previous Targets*2 New Targets Revenue 438.3 B yen 550.0 B yen 530.0 B yen EBITDA 179.3 B yen 200.0 B
Slide 16: Background of New KPI Setting
Background of New KPI Setting Progress of major businesses is smooth towards achieving Phase 2 KPIs and realizing the 2030 Vision Initial assumptions Current Progress Ensitrelvir • Delay in the start of sales in the US due to the failure to meet the primary endpoints of the SCORPIO-HR trial⇒Accelera
Slide 17: For Achieving STS2030 Revision Phase 2
For Achieving STS2030 Revision Phase 2 We will achieve the KPIs for FY2025 through "growth investments" and "growth in existing businesses" Growth Factor of Topline Growth investments 530.0 B yen • Recording revenue from M&A activities. Growth investments ‒ Revenue from JT Group‘s Pharmaceutical Div
Slide 18: Growth investments aimed at realizing our 2030 Vision
Growth investments Growth investments aimed at realizing our 2030 Vision Through the M&A of JT Group‘s Pharmaceutical Division, SHIONOGI has strengthened our R&D capabilities as well as our domestic product assets TORII PHARMACEUTICAL JT Pharmaceutical Division CO., LTD. • Discovery of drug candidat
Slide 19: Maximizing the value of domestic product assets
Growth investments Maximizing the value of domestic product assets Expansion of information activities to provide products that meet patient needs The launch of new products that both companies should focus on Vtama Quviviq Zulanolone Atopic Dermatitis/Plaque psoriasis Insomnia Depression 19 October
Slide 20: Growth Outlook for the HIV Market (Treatment + Prevention)
Existing 新製品・ businesses Growth Outlook for the HIV Market (Treatment + Prevention) 新規事業 In the treatment and PrEP*1 market, LA formulations will continue to drive growth Treatment Outlook for the HIV Market*2 (Treatment + PrEP) • In the US, new infections have increased by approximately 2.5-3% in r
Slide 21: Outlook for HIV Business by FY2025
Existing 新製品・ businesses Outlook for HIV Business by FY2025 新規事業 Data on the LA formulations has been accumulating as LA contributes increasingly to HIV business growth Real World Evidence at CROI 2025 *1, 2 Phase 2a trial data for S-365598 (oral)*3, *4 Cabenuva High adherence and long-term efficacy
Slide 22: Growth of Xocova in Japan
Existing 新製品・ businesses Growth of Xocova in Japan 新規事業 Continue to promote initiatives to improve the treatment rate of COVID-19 Variable Factor FY2023 FY2024 FY2025 Improve treatment rates Annual average of fixed points Annual average of fixed points Assuming the 8.0 5.2 Number of positive COVID-1
Slide 23: Characteristics of QUVIVIQ and the Insomnia Market
Existing 新製品・ businesses Characteristics of QUVIVIQ and the Insomnia Market 新規事業 Maximize product value early to address unmet needs in the field of insomnia QUVIVIQ Market size of insomnia treatments*2 Insomnia treatment (Launched in December 2024) Non-orexin receptor antagonists Improvement Improv
Slide 24: Launch of Zuranolone and ENDEAVORRIDE
Existing 新製品・ businesses Launch of Zuranolone and ENDEAVORRIDE 新規事業 Accelerate the growth of our business in Japan through the launch of innovative new products ENDEAVORRIDE Zuranolone Digital therapeutic App for pediatric patients with ADHD Depression treatment (FY2024: Manufacturing and marketing
Slide 25: Outlook for Overseas Business
Existing 新製品・ businesses Outlook for Overseas Business 新規事業 Promote appropriate use and further expand global access to cefiderocol US Asia and other regions • Strengthen information provision activities Leverage partners to expand into new markets • Expand sales regions Already launched countries/r
Slide 26: Future Business Development in China
Existing 新製品・ businesses Future Business Development in China 新規事業 Under the new structure as Shionogi (China) Co., Ltd., we will accelerate the development of our new drug business in China FY2025- FY2027- FY2030- Establishing a solid Launch of New Drug Business Accelerating growth foundation for C
Slide 27: Main Activities of STS2030 Revision Phase 2
Main Activities of STS2030 Revision Phase 2 Changes to STS2030 Revision Phase 2 KPIs Business investments aimed at new growth Growth of Existing Business Progress in pipeline 27
Slide 28: Global Expansion of Ensitrelvir
Global Expansion of Ensitrelvir Accelerating global rollout based on positive results from the SCORPIO-PEP study - Phase 3 Trial Results of Ensitrelvir (SCORPIO-PEP)- - Development status by country- The world’s first results demonstrating the preventive effect United States of an oral antiviral dru
Slide 29: Development Zatolmilast / S-898270
Development Zatolmilast / S-898270 Accelerating the development of two PDE4D inhibitors expected to improve cognitive function, aiming for the early delivery of solutions Zatolmilast S-898270 “Alzheimer’s Disease (Mild Cognitive “Aiming to become a First-in-Class treatment for two rare diseases” Imp
Slide 30: Future Development Policy for S-309309
Future Development Policy for S-309309 Considering the potential development of a highly safe anti-obesity drug that suppresses weight rebound after discontinuation of GLP-1 administration Challenges of existing treatments (GLP-1) Non-clinical trial results (monkeys) 1. Administered GLP-1 to obese m
Slide 31: S-151128: Phase 1b Trial Results
S-151128: Phase 1b Trial Results Although a favorable safety profile was confirmed with repeated administration, the expected efficacy was not observed Phase 1b Trial Overview Phase 1b Results In addition to safety and pharmacokinetics during repeated administration, exploratory efficacy was evaluat
Slide 32: R&D Milestones Planned for FY2025
R&D Milestones Planned for FY2025 ※Topline results: It is the timing of acquisition, and the timing of disclosure will be considered separately Disease area Pipeline Indication Current stage FY2025 1H FY2025 2H COVID-19 treatment Submission Submission（EU） COVID-19 PEP Submission Submission（US, EU） A
Slide 33: FY2025 Financial Forecasts and Shareholder Return
FY2025 Financial Forecasts and Shareholder Return 33
Slide 34: Budget assumptions
Budget assumptions Revenue Cost Prescription drugs Cost of Sales • Growth in the domestic Acute Respiratory Virus Infection • Increase in costs due to acquisition of domestic products and Treatment sales growth • Growth of Quviviq • Controlling cost ratio through further growth of products with lowe
Slide 35: Financial Results (FY2025 forecast)
Financial Results • Sales revenue and operating profit are expected to reach record Earnings highs for the fourth consecutive term forecast • All profit items are expected to increase • Investment towards achieving 2030 Vision will be further accelerated （Unit: B yen） FY2025 FY2024 FY2025 FY2024 FY2
Slide 36: Statement of Profit or Loss
Statement of Profit or Loss （Unit: B yen） FY2025 FY2024 FY2025 FY2024 FY2025 FY2024 Full year Change (%) Results 1H Change (%) 1H Results 2H Change (%) 2H Results Revenue 530.0 91.7 20.9 438.3 233.0 19.0 8.9 214.0 297.0 72.7 32.4 224.3 Cost of Sales 88.0 24.2 37.9 63.8 33.0 2.9 9.5 30.1 55.0 21.3 63
Slide 37: Revenue by Segment
Revenue by Segment （Unit: B yen） FY2025 FY2024 FY2025 FY2024 FY2025 FY2024 Full year Change (%) Results 1H Change (%) 1H Results 2H Change (%) 2H Results Prescription drugs 183.0 84.2 85.3 98.8 62.0 14.3 29.9 47.7 121.0 70.0 137.3 51.0 Overseas subsidiaries/export 54.9 (4.2) (7.1) 59.1 25.7 (2.6) (9
Slide 38: Prescription Drugs in Japan
Prescription Drugs in Japan （Unit: B yen） FY2025 FY2024 FY2025 FY2024 FY2025 FY2024 Full year Change (%) Results 1H Change (%) 1H Results 2H Change (%) 2H Results Acute Respiratory Virus Infection 85.8 34.0 65.7 51.8 31.0 6.1 24.7 24.9 54.8 27.9 103.4 26.9 Treatment Quviviq 9.3 8.5 - 0.8 1.2 1.2 - -
Slide 39: Shareholder Returns
Shareholder Returns Shareholder return policy through which shareholders can feel our growth • Enhance capital efficiency through share buybacks, cancellation of treasury shares, and unwinding of cross-shareholdings • The year-end dividend is planned to increase by 4 yen per share from the previous
Slide 40: Appendix
Appendix 40 @® snionoai
Slide 41: Financial Results
Financial Results （Unit: B yen） FY2024 FY2023 Y on Y Achievement Forecasts Results results Change(%) Change (%) Revenue 460.0 438.3 95.3 435.1 0.7 3.2 Operating profit 165.0 156.6 94.9 153.3 2.1 3.3 Profit before tax 206.0 200.8 97.5 198.3 1.2 2.5 Profit attributable to 171.0 170.4 99.7 162.0 5.2 8.
Slide 42: FY2024 and FY2025 Exchange Rate
FY2024 and FY2025 Exchange Rate Exchange Rate (Average) FY2024 FY2025 Forecast Results Forecast USD($) – JPY(¥) 148 152.62 147 GBP(£) – JPY(¥) 190 194.73 187 EUR(€) – JPY(¥) 161 163.88 153 42
Slide 43: Major Development Products
Major Development Products - Infection Diseases - - QOL Diseases - Target Launch Target Launch Pipeline Indication Current stage Timing* Pipeline Indication Current stage Timing* Preparation for COVID-19 treatment global - FY2027 Zuranolone Depression Submission FY2025 submission Pain associated wit
Slide 44: Pipeline: Infectious Disease
Pipeline: Infectious Disease as of May 12, 2025 Preclinical Phase 1 Phase 2 Phase 3 Submission 2025年1月31日現在 S-567123 S-743229 S-337395 Cefiderocol Ensitrelvir Ensitrelvir COVID-19 AMR (Complex urinary Aerobic Gram-negative COVID-19 treatment RSV infections COVID-19 treatment Universal vaccine tract
Slide 45: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of May 12, 2025 Preclinical Phase 1 Phase 2 Phase 3 Submission Resiniferatoxin S-540956 S-151128 S-309309 Redasemtide*3 [GRT7039] Zuranolone Nucleic acid adjuvant Chronic pain Obesity Acute ischemic stroke Pain associated with knee Depression osteoar
Slide 46: S-365598 Phase 2a Trial Design
S-365598 Phase 2a Trial Design Double-blind, randomized, placebo-controlled, proof-of-concept, phase 2a trial Inclusion criteria Endpoints S-365598 10 mg Q3D (N=6)a • Primary endpoint: Maximum change from Randomization • Aged 18-65 years • Naive to ART S-365598 50 mg Q3D (N=6)b baseline in plasma HI
Slide 47: Products licensed from SHIONOGI to ViiV Healthcare and key milestones
Products licensed from SHIONOGI to ViiV Healthcare and key milestones + S-365598*2 <Out-licensed product from SHIONOGI to ViiV> Cabotegravir*1 (Novel integrase (Integrase inhibitor) inhibitor) Red text: Update Q4M: ULA formulation administered once every 4 months, Q6M: ULA formulation administered o
Slide 48: Anti-HIV Drug Released by ViiV
Anti-HIV Drug Released by ViiV Product CY2024 Formulations Compounds Administrations Frequency Indications name Sales Cabenuva CAB＋RPV IM injection Q2M (LA) Treatment ￡1,013M Long Acting Apretude CAB IM injection Q2M (LA) PrEP ￡279M Dovato DTG＋3TC Oral Every day Treatment ￡2,239M Two-drug regimens J
Slide 49: Overview of Transaction
Overview of Transaction ① Succession of JT Pharmaceutical Division through a company split ② A public tender offer for TORII PHARMACEUTICAL CO., LTD. by SHIONOGI ③ Acquisition of shares of Akros Pharma Inc. by Shionogi Inc. JT Group‘s Pharmaceutical Division ①Business succession through a company sp
Slide 50: Transaction Process
Transaction Process With the successful completion of the tender offer for Torii's shares, all of JT’s Group Pharmaceutical Division will be transferred to SHIONOGI Implementation of a tender offer • Acquisition of own shares by Torii • The succession of JT Pharmaceutical Division • Complete subsidi
Slide 51: The Main Purchase Conditions for the Tender Offer by SHIONOGI for TORII
The Main Purchase Conditions for the Tender Offer by SHIONOGI for TORII Tender Offeror Shionogi & Co., Ltd Target Company TORII PHARMACEUTICAL CO., LTD. Methods Tender Offer Tender Offer Period(Planned) From Thursday, May 8, 2025 to Wednesday, June 18, 2025 (30 Business Days) Settlement start date(P
Slide 52: Actions Following the Announcement of This Transaction
Actions Following the Announcement of This Transaction Future planned actions September 2025：The effectiveness of the stock consolidation and acquisition of own shares ⇒ Torii will become a wholly-owned subsidiary of SHIONOGI • JT Pharmaceutical Division will be absorbed by SHIONOGI December 2025：Th
Slide 53: Business Stabilization - The Strength of TORII
Business Stabilization - The Strength of TORII - Torii is steadily growing by focusing on Allergy and Skin Diseases as its growth drivers The franchise field The sales revenue of Torii Allergens CAGR: The sales revenue is expected to reach a • Over the past few years, Torii has achieved strong growt
Slide 54: Utilization of SHIONOGI's own Production Capabilities
Utilization of SHIONOGI's own Production Capabilities SHIONOGI Group's own production facilities contributes to stable supply and cost reduction Research Development Production Sales SHIONOGI's own factories Settsu Plant Kanegasaki Plant Amagasaki Office Itami Plant Tokushima Plant For the products
Slide 55: Strengthening R&D Capabilities - JT Pharmaceutical Division's strengths
Strengthening R&D Capabilities - JT Pharmaceutical Division’s strengths - Excellent drug discovery achievements and a strong foundation in small molecule drug discovery Trametinb Delgocitinib Original (MEK inhibitor)/ Cancer (JAK inhibitor)/Atopic Dermatitis New Drugs Discovered Elvitegravir by JT E
Slide 56: Building the No. 1 Global Capabilities in Small Molecule Drug Discovery
Building the No. 1 Global Capabilities in Small Molecule Drug Discovery Strengthening our research capabilities to deliver the best medicines globally Strengthen Small molecule drug Discovering a promising discovery capabilities within the pipeline in the field of high area of infectious diseases so
Slide 57: Accelerating our Transformation into a Global Pharmaceutical Company
Accelerating our Transformation into a Global Pharmaceutical Company SHIONOGI has acquired JT Group's pharmaceutical Division as a whole, contributing to addressing the unmet needs of patients worldwide Global No.1 capabilities Global development of in-house products in small molecule drug discovery
Slide 58: Other Major Progress
Other Major Progress*1 • February − AI program for diagnostic support(SDS-881) for conversational cognitive function testing (neuropsychological testing) has been designated as a priority review item for program medical devices by the Ministry of Health, Labour and Welfare • March − Established the
Slide 59: 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