Shionogi & Co., Ltd. · TSE:4507
Shionogi & — Q1 FY2025 Earnings Presentation
40 slides from Shionogi &'s earnings presentation, Sep 2, 2025
Slide 1: 1st Quarter of Fiscal 2025 Financial Results
1st Quarter of Fiscal 2025 Financial Results July 28, 2025 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda 01 Overview of Q1 FY2025 Financial Results （P.3-8） 02 Progress of HIV Business （P.9-11） 03 Toward the Realization of the 2030 Vision （P.12-23） ⚫ Integration with JT Pharmaceutical Division ⚫ Advancement of the Pipeline 2
Slide 3: Overview of Q1 FY2025 Financial Results
Overview of Q1 FY2025 Financial Results 3
Slide 4: Q1 FY2025 Highlights
Q1 FY2025 Highlights Steady progress from both financial and non-financial perspectives ⚫ Achieved year-on-year growth in revenue and all profit metrics - Expansion of the HIV franchise ⚫ Successful completion of the tender offer for TORII*1 - Significant progress toward the integration of JT Group’
Slide 5: Financial Results
Financial Results Achieved year-on-year increases in revenue and across all profit categories （Unit: B yen) FY2025 FY2024 Y on Y Forecast Forecast Apr.-Jun. Achievement Apr.-Jun. Change (%) Change Full year 1H Results (%) Results Revenue 530.0 233.0 99.8 42.8 97.6 2.2 2.2 Operating profit 175.0 82.0
Slide 6: Statement of Profit or Loss
Statement of Profit or Loss （Unit: B yen) FY2025 FY2024 Y on Y Forecast Forecast Apr.-Jun. Achievement Apr.-Jun. Change(%) Change Full year 1H Results (%) Results Main variation Factors (Y on Y) Revenue 530.0 233.0 99.8 42.8 97.6 2.2 2.2 16.6 14.2 12.3 14.8 Cost of Sales Revenue 88.0 33.0 12.3 37.3
Slide 7: Revenue by Segment
Revenue by Segment （Unit: B yen) FY2025 FY2024 Y on Y Forecast Forecast Apr.-Jun. Achievement Apr.-Jun. Change(%) Change Main variation Factors (Y on Y) Full year 1H Results (%) Results Prescription drugs 183.0 62.0 14.1 22.8 15.4 (8.5) (1.3) Prescription drugs Overseas subsidiaries/export 54.9 25.7
Slide 8: Results for Q1 FY2025 and Future Outlooks
Results for Q1 FY2025 and Future Outlooks Driven by top-line growth and appropriate cost management, H1 forecast is expected to be achieved Results for Q1 Future outlooks • Continued growth of the HIV franchise and cefiderocol • Expansion of the HIV franchise led by ViiV Top-line • Increased sales o
Slide 9: Progress of HIV Business
Progress of HIV Business ® SHIONOGI
Slide 10: Progress of HIV Business by ViiV Healthcare
Progress of HIV Business by ViiV Healthcare The expansion of Long-Acting Injectables and oral two-drug regimens is accelerating, driving overall growth in the HIV business ViiV’s sales trends*1 YoY increase from the same period 1,800 Treatment Cabenuva (cabotegravir + rilpivirine) 1,600 1,400 + £81M
Slide 11: Development of ULA formulation: S-365598/VH184
Development of ULA*1 formulation: S-365598/VH184*2 (Third-generation Integrase Inhibitor) Candidate for multiple LAI formats, including Q6M, with potential to cover strains resistant to current INSTIs Key features of Distinct resistance profile compared Antiviral activity of S-365598/VH-184 against
Slide 12: Toward the Realization of the 2030 Vision
Toward the Realization of the 2030 Vision ⚫ Integration with JT Pharmaceutical Division ⚫ Advancement of the Pipeline 12
Slide 13: Premise for M&A: Outlook for Stable Management
Premise for M&A: Outlook for Stable Management The HIV business is expected to continue its steady growth Growth of HIV business Mid- to long-term HIV business outlook Build a highly efficient and robust earnings base HIV business will remain the backbone of the [Trends of HIV royalty income and div
Slide 14: Integration with JT Group's Pharmaceutical Business
Integration with JT Group’s Pharmaceutical Business M&A aligned with our management strategy reinforces our proprietary R&D and domestic commercial strength*1 SHIONOGI's Business Strategy*2: Delivering internally developed new drugs globally while pursuing Creation of proprietary Royalty business pr
Slide 15: M&A Prioritizing the Enhancement of In-House Drug Discovery Capabilities
Integration with JT Group’s Pharmaceutical Business: M&A Prioritizing the Enhancement of In-House Drug Discovery Capabilities Strengthening our proprietary pipeline through integration with JT Accelerating and enhancing the quality of the drug discovery cycle Pharmacology/ Safety and ADME Profiling
Slide 16: Integration with JT Group's pharmaceutical business: Domestic commercial strength
Integration with JT Group's pharmaceutical business: Domestic commercial strength*1 Sales of both companies' products are expanding through co-promotion with TORII Overview of the Co-promotion (Starting September 1): Product coverage will be expanded progressively Previous situation Post-Co-promotio
Slide 17: Achieving the 2030 Vision
Achieving the 2030 Vision ⚫ Integration with JT Pharmaceutical Division ⚫ Advancement of the Pipeline 17
Slide 18: COVID-19 Anti-Viral Drugs: Development Update
COVID-19 Anti-Viral Drugs: Development Update Significant progress in the global expansion of ensitrelvir, with steady advancement of S-892216 Ensitrelvir S-892216 Use in Previous Status Current Status Antiviral Activity DDI*1 Pregnant Women Compared to Indication: prevention existing therapies No c
Slide 19: S-337395: Results from the Phase 2a Human Challenge Study
S-337395: Results from the Phase 2a Human Challenge Study*1 Demonstrated strong antiviral activity and a trend toward symptom improvement, supporting development as an RSV therapeutic - Primary Endpoint: AUC of viral RNA load measured by qRT-PCR*2 - - Secondary endpoint: Time course of symptom score
Slide 20: S-337395: Upcoming Development Plan (Phase 2b trial)
S-337395*1: Upcoming Development Plan (Phase 2b trial overview and design) Initiate a Phase 2b trial in high-risk patients before year-end, accelerating development toward the world’s first oral RSV therapy Primary Endpoint Change from baseline in viral RNA load (qRT-PCR) Secondary Efficacy assessme
Slide 21: COVID-19 Vaccine Portfolio
COVID-19 Vaccine Portfolio S-268024 achieved the primary endpoint, advancing the vaccine business to the next stage Project Antigen Status Remarks COVGOZE Wuhan Approval ー (Q1 FY2024) ・Primary endpoint*1 not achieved S-268023 XBB1.5 Phase 3 completed (Confirmation of neutralizing antibody induction
Slide 22: S-268024: Phase 3 Results
S-268024: Phase 3 Results In the clinical trial, non-inferiority to vaccines of the same modality and favorable safety profile were confirmed ーStudy objective and primary endpointー ーGeometric mean neutralizing antibody titers (JN.1 variant)ー Comparison of neutralizing antibody titers against the SAR
Slide 23: Progress of Main Pipelines: QOL Diseases with High Social Impact
Progress of Main Pipelines: QOL Diseases with High Social Impact Steady progress toward establishing growth drivers in QOL indications Pipeline Indication Update Completion of regulatory submission in Naldemedine Opioid-induced constipation China*1 Last Patient In (LPI) achieved for the Redasemtide
Slide 24: Appendix
Appendix 24 @® shionoai
Slide 25: Prescription Drugs in Japan
Prescription Drugs in Japan （Unit: B yen) FY2025 FY2024 Y on Y Forecast Forecast Apr.-Jun. Achievement Apr.-Jun. Change(%) Change Full year 1H Results (%) Results Acute Respiratory Virus Infection 85.8 31.0 2.9 9.3 3.9 (25.8) (1.0) Treatments Quviviq 9.3 1.2 0.1 9.8 - ‐ 0.1 Symproic 8.1 3.9 1.5 37.6
Slide 26: FY2025 Exchange Rate
FY2025 Exchange Rate Exchange Rate (Average) FY2025 Forecast Apr.-Jun. Results USD($) – JPY(¥) 147 144.60 GBP(£) – JPY(¥) 187 193.03 EUR(€) – JPY(¥) 153 163.83 26
Slide 27: COVID-19 Anti-Viral Drugs: Post-Marketing Large-Scale Clinical Studies
COVID-19 Anti-Viral Drugs: Post-Marketing Large-Scale Clinical Studies A reduced risk of developing post-COVID-19 conditions (Long COVID) was observed with antiviral treatment Prospective observational study in COVID-19 patients at Tokushukai Group hospitals (ANCHOR studies) - Study design - - Inter
Slide 28: The M&A Process
The M&A 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 for minority • Acquisition of own shares by Torii • The succession of JT Pharmaceutical Division sharehold
Slide 29: Timeline of the M&A Transaction
Timeline of the M&A 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：The effectiveness of the
Slide 30: R&D Milestones Planned for FY2025
R&D Milestones Planned for FY2025 Red: Update from May 13, 2025, to July 28, 2025, : Milestone-completed items ※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 tre
Slide 31: Major Development Products
Major Development Products - Infection Diseases - - QOL Diseases - Target Launch Target Launch Pipeline Indication Current stage Timing*1 Pipeline Indication Current stage Timing*1 COVID-19 treatment Submission - FY2027 Zuranolone Depression Submission FY2025 Pain associated with Resiniferatoxin Pha
Slide 32: Pipeline: Infectious Disease
Pipeline: Infectious Disease as of July 28, 2025 Preclinical Phase 1 Phase 2 Phase 3 Submission 2025年1月31日現在 S-567123 S-743229 S-337395 Cefiderocol Olorofim Ensitrelvir COVID-19 AMR (Complicated urinary Aerobic Gram-negative RSV infections Invasive Aspergillosis COVID-19 treatment Universal vaccine
Slide 33: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of July 28, 2025 Preclinical Phase 1 Phase 2 Phase 3 as of July 28, 2025 Submission Resiniferatoxin S-540956 S-151128 S-309309 Redasemtide [GRT7039] Zuranolone Nucleic acid adjuvant Chronic pain Obesity Acute ischemic stroke Pain associated with knee
Slide 34: Ensitrelvir: Results of SCORPIO-PEP Study
Ensitrelvir: Results of SCORPIO-PEP Study The world’s first results demonstrating the preventive effect of an oral antiviral drug against the onset of COVID-19 - Phase 3 Trial Results of Ensitrelvir (SCORPIO-PEP)- -Primary Endpoint- - Stratified Analysis - Proportion of participants who developed CO
Slide 35: S-337395 Indications: RSV Infection
S-337395 Indications: RSV Infection Product Features: Mechanism of action: • Antiviral drug with a new mechanism of action (L protein inhibitor) - Compound discovered through joint research with UBE Inhibits the L protein, which is involved in the transcription and • Easy to use oral medication repl
Slide 36: S-337395: Non-clinical data
S-337395: Non-clinical data Compared to F protein inhibitors, this drug shows a clear virus reduction effect even when administered near the peak of viral replication RSV-infected mouse treatment model Respiratory syncytial virus Hepatitis A infection Treatment S-337395 F protein inhibitor period 5
Slide 37: 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 LAI formulations Apretude CAB IM injection Q2M (LA) PrEP ￡279M Dovato DTG＋3TC Oral Every day Treatment ￡2,239M Oral two-drug
Slide 38: Growth Outlook for the HIV Market (Treatment + Prevention)
新製品・ Existing 新規事業 businesses Growth Outlook for the HIV Market (Treatment + Prevention) 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 39: Other Major Progress
Other Major Progress*1 • May − A basic agreement was signed among three companies for the development and operation of a DTx distribution platform • June − The "Resource Circulation Project," which aims for horizontal recycling of bell mount paperboard, received the Silver Award in the Special Award
Slide 40: 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