Shionogi & Co., Ltd. · TSE:4507
Shionogi & — Q1 FY2026 Earnings Presentation
44 slides from Shionogi &'s earnings presentation, Aug 3, 2026
Slide 1: 1st Quarter of Fiscal 2026 Financial Results and HIV Business Update
1st Quarter of Fiscal 2026 Financial Results and HIV Business Update August 3, 2026 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda 1st Quarter of Fiscal 2026 Financial Results P.3-21 01 Overview of 1Q FY2026 Financial Results （P.3-8） 02 Progress of Key Businesses （P.9-14） 03 Progress of Development Pipeline （P.15-21） HIV Business Update P.22-32 2
Slide 3: Overview of 1Q FY2026 Financial Results
Overview of 1Q FY2026 Financial Results 3
Slide 4: Significant Growth of Key Businesses
Significant Growth of Key Businesses Revenue reached a record high for the first quarter, driven by growth of existing businesses and integration effects from acquired businesses -Revenue Growth Trend- Domestic prescription drugs sales: +137.3% (YoY) • Integration Benefits from Business Investments.
Slide 5: Financial Results (Consolidated)
Financial Results (Consolidated) Year-on-year growth achieved revenue and all profit categories （Unit: B yen) FY2026 FY2025 YoY Forecast Forecast Apr.-Jun. Achievement Apr.-Jun. Change (%) Change Full year 1H Results (%) Results Revenue 700.0 340.0 163.3 48.0 99.8 63.7 63.5 Operating profit 220.0 96
Slide 6: Statement of Profit or Loss (Consolidated)
Statement of Profit or Loss (Consolidated)（Unit: B yen) FY2026 FY2025 YoY Main variation factors (YoY) Forecast Forecast Apr.-Jun. Achievement Apr.-Jun. Full year 1H Results (%) Results Change(%) Change Revenue Increase: Royalty income, domestic prescription drugs, Revenue 700.0 340.0 163.3 48.0 99.
Slide 7: Revenue by Segment
Revenue by Segment （Unit: B yen) FY2026 FY2025 YoY Main variation factors (YoY) Forecast Forecast Apr.-Jun. Achievement Apr.-Jun. Change(%) Change Full year 1H Results (%) Results Prescription drugs 178.6 79.9 33.5 42.0 14.1 137.3 19.4 Prescription drugs Overseas subsidiaries/export 175.2 85.4 42.2
Slide 8: 1Q Results and Future Outlook
1Q Results and Future Outlook Steady progress toward achievement of 1H forecast through further growth of key businesses Record-high 1Q results for revenue and all profit items 1Q results • Performance expanded through growth of key businesses and integration effects from acquired businesses • Conti
Slide 9: Progress of Key Businesses
Progress of Key Businesses ® SHIONOGI
Slide 10: Progress of ViiV's HIV Franchise
Progress of ViiV’s HIV Franchise Long-acting injectable portfolio powers HIV growth and market share increases ViiV Sales Trend (LAI formulations) ーTreatmentー 700 Cabenuva Apretude 153M 35 Revenue (CY2026 2Q) Growth rate (YoY) 453 M + 33 % 600 YoY +￡ (+ %) 500 ￡ 400 • U.S.: 77% of patients switching
Slide 11: RADICAVA Business Progress
RADICAVA Business Progress Achieved record-high 1Q revenue through a smooth business transition and effective PMI*1 execution RADICAVA Sales Trend in U.S. and Canada Growth-driving Actions*2 200 1 2 3 150 Grow: Increase New Convert: Improve Maintain: Keep Patients Patients Prescribed Access and Conv
Slide 12: U.S. Launch of XOCOVA (Post-Exposure Prophylaxis for COVID-19)
U.S. Launch of XOCOVA (Post-Exposure Prophylaxis for COVID-19) Driving adoption of post-exposure prophylaxis as a new option Interest in PEP*1 and Physicians' Willingness to Prescribe*2 Key Ongoing Actions 1 Promoting Awareness and Healthcare- Seeking Behavior Individuals at High Risk of Severe Dise
Slide 13: Cefiderocol Growth
Cefiderocol Growth Maximizing product value through the promotion of appropriate use Revenue Growth (Europe 売上収益の推移 （欧米）and U.S.) Key Achievements and Actions 50 Achieved over 40B yen in annual revenue • Continued revenue growth - FY2026 1Q Revenue: 12.7 B yen 40 > Europe: YoY +1.5 B yen (+44.9%) 2Q
Slide 14: Progress in Domestic Business
Progress in Domestic Business Diversified product portfolio drives stable growth in the domestic business Share of domestic business revenue (1Q) Products of Torii Pharmaceutical Quviviq (Insomnia treatment ) +19.4B yen（+137.3 ） 1Q revenue: 18.8 B yen*3 1Q revenue: 1.5 B yen YoY ％ • Increased shipme
Slide 15: Progress of Development Pipeline
Progress of Development Pipeline 15
Slide 16: Olorofim: Phase 3 Study Results (Preliminary)
Olorofim: Phase 3 Study Results (Preliminary) Achievement of the primary endpoint, with regulatory filings planned in Europe and Asia Study overview Study results (preliminary)*1 Primary endpoint Safety results Global multicenter, randomized, assessor-blinded, Study design active-controlled, Phase 3
Slide 17: Treatment Challenges in Invasive Aspergillosis
Treatment Challenges in Invasive Aspergillosis Treatment options remain limited for patients who cannot receive azole antifungals Current Treatment Landscape in Invasive Aspergillosis Expectations for New Alternative Treatment Options Patient Population • Estimated annual diagnoses exceed 200,000 1.
Slide 18: Contributing to AMR Measures in the Fungal Disease Area
Contributing to AMR Measures in the Fungal Disease Area Providing a new treatment option for fungal infections that are difficult to treat with existing therapies Key Product Attributes of Olorofim Potent Antifungal Activity Favorable Safety Profile An Oral Treatment Option -Active against azole-res
Slide 19: R&D Milestones for FY2026 (Infectious Disease Areas)
R&D Milestones for FY2026 (Infectious Disease Areas) Red text: Changes from May 13, 2026, to August 3, 2026, ✓: Milestone achieved The list of applicable assets is planned to be updated on a rolling basis Top-line results: This indicates the timing of data acquisition, and the timing of disclosure w
Slide 20: R&D Milestones for FY2026 (QOL Disease Areas)
R&D Milestones for FY2026 (QOL Disease Areas) The list of applicable assets is planned to be updated on a rolling basis Top-line results: This indicates the timing of data acquisition, and the timing of disclosure will be considered separately Development Target launch Target diseases FY2026 1H FY20
Slide 21: R&D Outlook / Future R&D Outlook
R&D Outlook / Future R&D Outlook Integrated R&D pipeline to be unveiled at the R&D Day on November 18, 2026 Current development pipeline total: 65 projects Former JT Shionogi Pharmaceutical Business Torii Pharmaceutical 42 projects 23 projects 21
Slide 22: HIV Business Update
HIV Business Update ® SHIONOGI
Slide 23: Products containing integrase inhibitors licensed by SHIONOGI
Products containing integrase inhibitors licensed by SHIONOGI ViiV’s INSTI1-based therapies containing dolutegravir or cabotegravir Approval2 Formulations Product name Approval2 Formulations Product name Oral Oral CY2013 （single agent） CY2019 （two-drug regimen） Daily Daily Oral LAI3 CY2014 （three-dr
Slide 24: Integrase Inhibitors Are the Gold Standard for HIV Treatment
Integrase Inhibitors Are the Gold Standard for HIV Treatment Following the launch of dolutegravir, the majority of the market was replaced by integrase inhibitor-based therapies HIV treatment is now primarily based on combination therapy with 2-3 drugs, including an integrase inhibitor —Establishing
Slide 25: Sales Growth of ViiV and the Integrase Inhibitor Portfolio
Sales Growth of ViiV and the Integrase Inhibitor Portfolio ViiV’s growth continues, driven by the integrase inhibitor portfolio -Regimens with INSTI at the core driving ViiV’s growth- -Integrase inhibitors are amongthe most widely used drugs globally- The sales share of integrase inhibitors 8000 Sal
Slide 26: Unmet Needs of People Living with HIV Are Changing
Unmet Needs of People Living with HIV Are Changing Since the launch of dolutegravir, we’ve seen a shift in the market to focus on quality of life, not just viral suppression Treatment is a three- Development of two-drug Toward development of drug regimen regimens LAI formulations -Triumeq- -Dovato,
Slide 27: Creation of LAI Integrase Inhibitor: Cabenuva (6× a year)
Creation of LAI Integrase Inhibitor: Cabenuva (6× a year) No long-acting injectable integrase inhibitors other than ViiV/Shionogi INSTIs projected to be approved until after 2030 ーWhy was development possible?ー ーStrengths of cabotegravirー Development of LAI INSTI is highly challenging The only appro
Slide 28: LAIs Expected to Drive Growth Beyond 2030
LAIs Expected to Drive Growth Beyond 2030 Continued innovation in LAIs positions ViiV to lead the future of the HIV market -Foundation for ViiV’s sustained long-term growth -Significant near-term growth drivers- Unsolved public health need Long-acting HIV treatment is -Toward Sustained Growth- the l
Slide 29: 3× a year LAI Treatment (CAB+RPV)
3× a year LAI Treatment (CAB+RPV) Lowering the dosing frequency of the marketed LAI therapy Cabenuva to enhance convenience Extending dosing intervals from 6× to 3× a year- Two-drug regimen Ⅰ Ⅱ Ⅲ Ⅳ Cabotegravir (CAB*1) Confidence 365 → 3 Doubles Unlocks INSTI ＋ builds on patient clinic LAI substanti
Slide 30: 2× a year LAI Treatment (VH184+VH499)
2× a year LAI Treatment (VH184+VH499) Best-in-class profile transforms adherence, setting a new standard of care -Advancing toward 2× a year LAI treatment- Two-drug regimen Ⅰ Ⅱ Ⅲ Ⅳ S-365598 (VH184) VH184 VH499 Broadest Ongoing INSTI ＋ 1st third-gen INSTI highly potent capsid patient VH184 with enhan
Slide 31: CAB (3× a year Prevention)
CAB (3× a year Prevention) 3× a year Prevention : The optimal choice for patients and healthcare providers -Extending dosing intervals from 6× to 3× a year- Single-agent Ⅰ Ⅱ Ⅲ Ⅳ Confidence 1 Optimal Preferred Cabotegravir (CAB*1) INSTI builds on Apretude’s intramuscular dosing aligns with ISR*4 prof
Slide 32: HIV Market Size (CY2025-CY2035)
HIV Market Size（CY2025-CY2035） HIV market value rapidly shifting from daily orals therapies to LAIs Global Treatment U.S. Prevention Treatment remains the largest segment, representing the majority of the HIV market The prevention market is expected to grow with LAIs, ~￡25bn*1 but remain smaller tha
Slide 33: Appendix
Appendix 33
Slide 34: Revenue for Prescription Drugs in Japan
Revenue for Prescription Drugs in Japan （Unit: B yen） FY2026 FY2025 YoY Forecast Forecast Apr.-Jun. Achievement Apr.-Jun. Change (%) Change Full year 1H Results (%) Results Acute Respiratory Virus Infection drugs 41.6 16.2 0.4 2.3 2.9 (87.2) (2.5) Quviviq 6.7 2.9 1.5 52.5 0.1 - 1.4 Zurzuvae 4.0 1.1
Slide 35: Revenue for TORII Pharmaceutical Related Products
Revenue for TORII Pharmaceutical Related Products （Unit: B yen) FY2026 FY2025 YoY Forecast Forecast Apr.-Jun. Achievement Apr.-Jun. Change (%) Change Full year 1H Result*1 (%) Results*2 Dermatology Area 23.0 11.1 5.9 53.5 5.5 7.1 0.4 Corectim 9.5 4.9 2.6 53.0 2.5 4.5 0.1 Vtama 4.2 1.6 0.6 38.0 0.7 △
Slide 36: FY2026 Exchange Rate
FY2026 Exchange Rate Exchange Rate (Average) FY2026 Forecast Apr.-Jun. Results USD($) – JPY(¥) 153 159.57 GBP(£) – JPY(¥) 205 214.00 EUR(€) – JPY(¥) 184 185.42 36
Slide 37: Pipeline: Infectious Diseases
Pipeline: Infectious Diseases as of August 3, 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 infect
Slide 38: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of August 3, 2026 Preclinical Phase 1 Phase 2 S-540956 S-588210 S-261261(JTV-261) S-531011 Redasemtide Zatolmilast Nucleic acid adjuvan Solid tumor Thrombosis Solid tumor Acute ischemic stroke Jordan syndrome S-109802 S-740792 S-662662(JTT-662) Nalde
Slide 39: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of August 3, 2026 Phase 3 Submission Zatolmilast SR-0379 Tapinarof Delgocitinib Tapinarof Atopic dermatitis Fragile X Syndrome Cutaneous ulcer Atopic dermatitis in infants Atopic dermatitis in pediatric patients (New dosage form) SDS-881 Cantharidin
Slide 40: Start of the RADICAVA Business in the U.S.
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 communication with
Slide 41: Patient Support in the RADICAVA Business: Three Pillars
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 Initiation Continued Trea
Slide 42: Ensitrelvir: Positive Results From the SCORPIO-PEP Trial
Ensitrelvir: Positive Results From the SCORPIO-PEP*1 Trial Demonstrated the world's first preventive effect against the onset of COVID-19 with an oral antiviral drug*2 -Trial design*3- - Phase 3 Trial Results of Ensitrelvir (SCORPIO-PEP)- Country US, South America, Africa, Asia including Japan The w
Slide 43: 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 44: 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