Shionogi & Co., Ltd. · TSE:4507
Shionogi & — FY2025 Earnings Presentation
50 slides from Shionogi &'s earnings presentation, May 12, 2026
Slide 1: Fiscal 2025 Financial Results
Fiscal 2025 Financial Results May 12, 2026 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda 01 Overview of FY2025 Financial Results （P.3-9） 02 FY2026 Financial Forecasts （P.10-16） 03 Toward the Realization of the 2030 Vision （P.17-37） • Initiatives in core businesses • Progress in pipeline 04 Shareholder Return （P.38-40） 2
Slide 3: Overview of FY2025 Financial Results
Overview of FY2025 Financial Results 3
Slide 4: Financial Highlights
Financial Highlights Revenue and all profit categories exceeded record highs - Revenue and operating profit reached record highs for the fourth consecutive fiscal year Completion of Equity Acquisition in ViiV Healthcare Ltd. (ViiV)*1 - March 31, 2026: ViiV was reclassified as an equity-method af
Slide 5: Financial Results (Consolidated)
Financial Results (Consolidated) Revenue and all profit categories increased year on year (Unit: B yen) FY2025 FY2024 YoY Forecasts Achievement Results Results Change (%) Change Full year (%) Revenue 500.0 499.7 99.9 438.3 14.0 61.4 Operating profit 185.0 166.7 90.1 156.6 6.5 10.1 Profit before tax
Slide 6: Statement of Profit or Loss (Consolidated)
Statement of Profit or Loss (Consolidated) (Unit: B yen) FY2025 FY2024 YoY Main variation factors (YoY) Achievem Forecasts Results ent Results Change Change Revenue Full year (%) (%) Increase: Royalty income, Prescription drugs, Revenue 500.0 499.7 99.9 438.3 14.0 61.4 Overseas subsidiaries /export
Slide 7: Revenue by Segment
Revenue by Segment (Unit: B yen) FY2025 FY2024 YoY Main variation factors (YoY) Forecast Results Achievement (%) Results Change Change Prescription drugs Full year (%) • Increase: Sales of TORII and Quviviq Prescription drugs 143.5 123.5 86.0 98.8 25.0 24.7 • Decrease: Sales of acute respiratory vir
Slide 8: Prescription Drugs in Japan
Prescription Drugs in Japan （Unit: B yen) FY2025 FY2024 YoY Forecast Achievement Change Results Results Change Full year (%) (%) Acute Respiratory Virus Infection Treatments 56.0 33.8 60.3 51.8 (34.8) (18.0) Quviviq 2.5 2.6 103.2 0.8 224.1 1.8 Symproic 6.5 6.1 94.2 5.0 21.2 1.1 OxyContin franchise 5
Slide 9: Summary of FY2025 Performance
Summary of FY2025 Performance Driven by growth in key businesses, revenue and all profit metrics reached record highs ーYear-on-yearー ーVersus forecastー Top-line growth excluding the impact of M&A Operating profit shortfall • Sales growth of Quviviq following the lifting of • Recognition of expenses r
Slide 10: FY2026 Financial Forecasts
FY2026 Financial Forecasts 10
Slide 11: Financial Forecast (Consolidated)
Financial Forecast (Consolidated) • Revenue is expected to expand significantly toward the JPY 800 billion target under the 2030 Vision Earnings • Revenue and operating profit are expected to reach record highs for the fifth forecast consecutive year • Profit attributable to owners of parent is expe
Slide 12: Overview of Financial Forecast
Overview of Financial Forecast Achieve dramatic revenue growth through M&A Revenue Cost of sales • Domestic prescription pharmaceuticals • Ongoing efforts to reduce costs • One-time costs related to inventory valuation of - Annual sales growth for flagship products such as Torii Edaravone Pharmaceut
Slide 13: Financial Impact of Changes in ViiV Healthcare Shareholding
Financial Impact of Changes in ViiV Healthcare Shareholding P/L Before Changes P/L After Changes*1 ViiV-Related Income Recognition Line Item ViiV-Related Income Recognition Line Item ① HIV Royalty P/L Revenue ① HIV Royalty P/L Revenue ② Dividend income (10% stake) P/L Financial income ② Dividend inc
Slide 14: Statement of Profit or Loss Forecast (Consolidated)
Statement of Profit or Loss Forecast (Consolidated) （Unit: B yen） FY2026 FY2025 YoY Forecast Full year Forecast 1H Result Change(%) Change Revenue 700.0 340.0 499.7 40.1 200.3 Cost of Sales 120.0 64.0 82.5 45.5 37.5 Gross profit 580.0 276.0 417.2 39.0 162.8 SG&A*1, R&D expenses total 395.0 197.0 255
Slide 15: Revenue Forecast by Segment
Revenue Forecast by Segment （Unit: B yen） FY2026 FY2025 YoY Forecast Full year Forecast 1H Result Change(%) Change Prescription drugs 178.6 79.9 123.5 44.7 55.2 Overseas subsidiaries/export 175.2 85.4 65.0 169.7 110.3 Shionogi Inc. (US) 138.7 68.0 28.7 382.7 110.0 RADICAVA 101.7 51.8 - - 101.7 Shion
Slide 16: Revenue Forecast for Prescription Drugs in Japan
Revenue Forecast for Prescription Drugs in Japan （Unit: B yen） FY2026 FY2025 YoY Forecast Full year Forecast 1H Result Change(%) Change Acute Respiratory Virus Infection drugs 41.6 16.2 33.8 23.0 7.8 Quviviq 6.7 2.9 2.6 157.7 4.1 Zurzuvae 4.0 1.1 0.5 - 3.5 Radicut 7.0 3.5 - - 7.0 Symproic 6.4 3.1 6.
Slide 17: Toward the Realization of the 2030 Vision
Toward the Realization of the 2030 Vision • Initiatives in core businesses • Progress in pipeline 17
Slide 18: From “Stable Growth” to “Accelerated Growth”
From “Stable Growth” to “Accelerated Growth” Overseas Business Domestic Business HIV Business Start of the edaravone Application of the equity Stabilization of the business method to ViiV Healthcare infectious disease business ‒ Entry into the rare disease business ‒ Stronger commitment to the
Slide 19: Start of the RADICAVA Business in the U.S.
Overseas Business Start of the RADICAVA Business in the U.S. Leveraging the strengths of the established operating company to contribute to patients who have not yet gained access – Improving Access to Treatment – ーStrengths of RADICAVA Operating Companyー ALS patients*1 (approx. 33,000 people) Deep
Slide 20: Patient Support in the RADICAVA Business: Three Pillars
Overseas Business Patient Support in the RADICAVA Business: Three Pillars Provide comprehensive patient support tailored to each phase from diagnosis through treatment continuation 1 2 3 Timely and Reliable Support Streamlining Treatment Building a Foundation for for Newly Diagnosed Patients Initiat
Slide 21: Significant Growth of the U.S. Business and Substantial Strengthening of the Network
Overseas Significant Growth of the U.S. Business Business and Substantial Strengthening of the Network Steadily expand the U.S. business by leveraging partnerships with the U.S. Government • Acquisition of β-lactamase inhibitors • Strengthened U.S. network Accelerate development of S-892216 Launch o
Slide 22: Domestic Business Enters a Phase of Stable Growth
Domestic Business Domestic Business Enters a Phase of Stable Growth Drive stable growth through two pillars: Infectious Diseases and QOL Diseases ーRevenue from domestic prescription pharmaceuticals and its breakdownー ーOutlook: Stable growth of the domestic businessー Revenue Sales Ratio （Planned） Exp
Slide 23: Stable Earnings Contribution from Acute Respiratory Infection Treatments
Domestic Business Stable Earnings Contribution from Acute Respiratory Infection Treatments Promote initiatives to contribute to patients in line with infectious disease trends 80 70 ーTrends in the Number of COVID-19 / Influenza Patientsー Number of reported cases per 60 ーMedical Societies Promoting A
Slide 24: Toward Significant Growth of Two Focus Products in QOL Diseases area
Domestic Business Toward Significant Growth of Two Focus Products in QOL Diseases area Position the two focus products as growth drivers and pillars of the QOL disease portfolio ーSales revenue in the QOL disease areaー 40 Zurzuvae (for MDD) + 3.5 B yen (YoY) • Emphasize rapid onset of efficacy and sh
Slide 25: Torii Pharmaceutical Products to Deliver Growth Exceeding the Previous Year
Domestic Torii Pharmaceutical Products to Deliver Growth Business Exceeding the Previous Year Growth in the allergen and dermatology areas is expected to drive sales revenue to a record high Sales Revenue of Torii Pharmaceutical Products*1 100 Allergen Area*2 + Others + 6.9 B yen YoY + 13.2 % 80 • C
Slide 26: Strong Growth of the HIV Business and Outlook for the Year
HIV Business Strong Growth of the HIV Business and Outlook for the Year Driven by the growth of LAI formulations, HIV sales by ViiV are expected to grow mid- to high single-digit growth in FY2026 Sales Trend Since Launch of LAI Formulations by ViiV ーTreatmentー 2000 Sales (CY2025) Growth (YoY) 1,402
Slide 27: Development of next Generation of LAI’s for HIV Treatment
HIV Business Development of next Generation of LAI’s for HIV Treatment Longer dosing intervals are expected to drive greater uptake of LAI treatment products CY2021 CY2028 -CY2030 6x yearly 3x yearly Twice yearly -Q2M- -Q4M- -Q6M- -dosing once every two months- -dosing once every four months- -dosin
Slide 28: What is S-365598 (VH-184)?
HIV Business What is S-365598 (VH-184)? A potential third-generation integrase inhibitor with unique features discovered by SHIONOGI 01 02 03 Potent Distinct resistance profile Long-acting durability antiviral activity Compared with existing agents Potential for twice yearly dosing Retains activity
Slide 29: Toward the Realization of the 2030 Vision
Toward the Realization of the 2030 Vision • Initiatives in core businesses • Progress in pipeline 29
Slide 30: Major Pipeline Progress (FY2025)
Major Pipeline Progress (FY2025) Infectious Diseases QOL Diseases with High Social Impact Post-exposure prophylaxis: Ensitrelvir*1 Submitted in the US and Europe, approved in Japan Zuranolon*3 Approved in Japan COVID-19 Treatment: Submitted in Europe, submitted in Japan Depression (Pediatric patient
Slide 31: Zatolmilast: Phase 2/3 trial results (Fragile X syndrome)
Zatolmilast: Phase 2/3 trial results (Fragile X syndrome) Although the primary endpoint was not met, statistically significant improvements were observed across multiple endpoints —Study overview— —Summary of analysis results— This study evaluated the efficacy of Zatolmilast over a 13-week Group dif
Slide 32: Zatolmilast: Future Strategy
Zatolmilast: Future Strategy Based on the results of the pivotal trials, the development strategy will be determined in the second half of 2026 ーOngoing clinical trialsー Fragile X syndrome Jordan syndrome Phase 2/3 trials Phase 3 trials (Open-label long-term extension) Phase 2 trials • Top-line resu
Slide 33: S-606001: Mechanism of Action and Development Status
S-606001： Mechanism of Action and Development Status S-606001, a novel treatment approach, achieved FPI in Phase 2 trials*1, with development progressing as planned ーCauses and treatments of Pompe diseaseー —Development status— Pompe disease: A rare disease that is one of the lysosomal storage diseas
Slide 34: Expanding of the Development Pipeline through M&A
Expanding of the Development Pipeline through M&A Acquiring promising pipeline assets from former JT pharmaceutical business and Torii Preclinical Phase 1 Phase 2 Phase 3 Submission S-462462 S-064064 (JTC-064) S-262262 (JTC-262) S-051051 (JTE-051) TO-203 Tapinarof Tapinarof Interstitial cystitis/ At
Slide 35: Pipeline Prioritization
Pipeline Prioritization While advancing ongoing clinical trials, we plan to review and refocus the pipeline through strategic prioritization Current status Future actions Undertaking intensive review of each program from 1 Assessments will incorporate results from scientific, clinical, and commercia
Slide 36: R&D Milestones Planned for FY2026 (Infectious disease areas)
R&D Milestones Planned for FY2026 (Infectious disease areas) The list of applicable assets is planned to be updated on a rolling basis Topline results: It is the timing of acquisition, and the timing of disclosure will be considered separately Development Target launch Target diseases FY2025 FY2026
Slide 37: R&D Milestones Planned for FY2026 (QOL disease areas)
R&D Milestones Planned for FY2026 (QOL disease areas) The list of applicable products will be updated sequentially, including assets inherited from the former JT Group pharmaceutical business Topline results: It is the timing of acquisition, and the timing of disclosure will be considered separately
Slide 38: Shareholder Returns
Shareholder Returns ® SHIONOGI
Slide 39: Basic Policy for Cash Allocation
Basic Policy for Cash Allocation Appropriately allocating expanding cash flows to growth investments and shareholder returns Growth investments • Continued investment in R&D to support strong in-house drug discovery capabilities • Strategic business investments to acquire new growth drivers Sustaina
Slide 40: Dividend per share (yen)
Shareholder Return Shareholder return policy through which shareholders can feel our growth • The year-end dividend is scheduled to be increased by 5 yen per share from the previous dividend forecast to 38 yen per share • The annual dividend is scheduled to be 71 yen per share, marking the 14th cons
Slide 41: Appendix
Appendix 4 @® snionoai
Slide 42: Factors Affecting the Increase / Decrease in Operating Profit (vs. Forecast)
Factors Affecting the Increase / Decrease in Operating Profit (vs. Forecast) △18.3 • SG&A - Increased investment in the U.S. business 333 △33.3 - Amortization of intangible assets (B yen) (JT Group pharmaceutical business) 185.0 - Increase in expenses due to foreign exchange ① ② effects △3 △0.3 △0.5
Slide 43: Revenue Forecast for TORII Pharmaceutical Related Products
Revenue Forecast for TORII Pharmaceutical Related Products （Unit: B yen） FY2026 FY2025 YoY Forecast Forecast 1H Result Change(%) Change Full year Dermatology Area 23.0 11.1 11.7 95.5 11.2 Corectim 9.5 4.9 5.2 83.4 4.3 Vtama 4.2 1.6 1.4 206.8 2.8 Allergen Area・Others 54.6 25.7 28.8 89.6 25.8 TORII Ph
Slide 44: Changes in Financial Position
Changes in Financial Position Implemented agile financing in connection with growth investments aimed at enhancing mid- to long-term corporate value Total Assets Equity attributable to owners of parent End of End of (Unit: B yen) Unit: B yen Change Mar. 2025 Mar. 2026 2,576.9 Non-current Assets 676.
Slide 45: Pipeline: Infectious Diseases
Pipeline: Infectious Diseases as of May 12, 2026 Preclinical Phase 1 Phase 2 Phase 3 Submission 2025年1月31日現在 S-872600 S-649228 S-337395 S-268019 Ensitrelvir Cefiderocol AMR (Gram-negative COVID-19 vaccine AMR (Gram-negative Influenza nasal vaccine RSV infections COVID-19 treatment bacterial infectio
Slide 46: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of May 12, 2026 Preclinical Phase 1 Phase 2 S-540956 S-588210 S-261261 S-531011 Redasemtide Zatolmilast Nucleic acid adjuvan Solid tumor Thrombosis Solid tumor Acute ischemic stroke Jordan syndrome S-109802 S-740792 S-662662 Naldemedine Redasemtide S
Slide 47: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of May 12, 2026 Phase 3 Submission Zatolmilast SR-0379 Tapinarof Naldemedine Tapinarof Fragile X Syndrome Cutaneous ulcer Atopic dermatitis in infants Opioid-induced Constipation Atopic dermatitis in pediatric patients SDS-881 Delgocitinib Cantharidi
Slide 48: S-606001: Phase 2 Trial Overview
S-606001：Phase 2 Trial Overview Design Multicenter, randomized, placebo-controlled, double-blind trial • Patients with late-onset Pompe disease (18 years of age or older) Subject • Patients who have received enzyme replacement therapy (ERT) for more than two years and whose dosage and administration
Slide 49: Anti-HIV Drug Released by ViiV
Anti-HIV Drug Released by ViiV Product CY2025 Formulations Compounds*1 Administrations Frequency Indications name Sales Cabenuva CAB＋RPV IM injection Q2M (LA) Treatment ￡1,402M LAI formulations Apretude CAB IM injection Q2M (LA) PrEP*2 ￡439M Dovato DTG＋3TC Oral Every day Treatment ￡2,678M Oral two-d
Slide 50: 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