Slide 1: Fiscal 2023 Financial Results
Fiscal 2023 Financial Results May 13, 2024 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda 01 Overview of FY2023 Financial Results （P.3-12） 02 FY2023 initiatives and FY2024 outlook （P.13-25） ٠ Infectious Diseases • QOL Diseases with High Social Impact 03 FY2024 Financial Forecasts （P.26-34） 04 Shareholder Return （P.35-36） 2
Slide 3: Overview of FY2023 Financial Results
Overview of FY2023 Financial Results 3
Slide 4: Financial Results
Financial Results • We achieved a record-breaking revenue and operating profit last fiscal year, surpassing our previous best performance - The sales of Xocova and Xofluza in the domestic market, along with our HIV business, have grown into a stable revenue base Highlight • Our profit before tax and
Slide 5: Growth of Topline
Growth of Topline We achieved growth across all businesses, centered around a dramatic expansion in our direct sales ＋8.4 B yen 426.7 435.1 (Unit: B yen) 25.0* 2 One-time factors 100.0 * Prescription drugs 126.1 ＋46.5 Other than the above 79.7 49.9 ＋7.4 Overseas subsidiaries/export 42.5 Royalty inco
Slide 6: Statement of Profit or Loss
Statement of Profit or Loss (Unit: B yen) FY2023 FY2022 Y on Y Forecast Achievement Results Results Change (%) Change (Oct. 31) (%) Revenue 450.0 435.1 96.7 426.7 2.0 8.4 13.2 13.2 14.6 Cost of Sales 59.5 57.6 96.8 62.2 (7.5) (4.6) Gross profit 390.5 377.5 96.7 364.4 3.6 13.0 Selling, general & admi
Slide 7: Main Variation Factors of Operating Profit (Y on Y)
Main Variation Factors of Operating Profit (Y on Y) 4.3 Revenue Increase Overseas subsidiaries/export, Royalty income Decrease Purchase of Xocova by the Japanese government （Unit: B yen） 4.6 (6.6) in FY2022 8.4 (1.9) (0.2) Cost of Sales Decrease in expenses • Changes in product mix 149.0 153.3 Other
Slide 8: Revenue by Segment
Revenue by Segment (Unit: B yen) FY2023 FY2022 Y on Y Forecast Achievement Change Results Results Change (Oct. 31) (%) (%) Prescription drugs 167.0 151.1 90.5 179.7 (15.9) (28.6) Excluding temporary income - 126.1 - 79.7 58.1 46.4 Temporary income - 25.0 - 100.0 - (75.0) Overseas subsidiaries/export
Slide 9: Main Variation Factors of Revenue (Y on Y)
Main Variation Factors of Revenue (Y on Y) ＋8.4 Prescription drugs （Unit: B yen） 7.4 2.3 1.5 0.2 • Sales of Xocova and Xofluza 25.7 (28.6) • Receipt of lump-sum income for transfer of ADHD Increase drugs in Q1 FY2023 (One-time factors) • Returns of Xofluza and Rapiacta in FY2022 • Sales of ADHD drug
Slide 10: Prescription Drugs in Japan
Prescription Drugs in Japan (Unit: B yen) FY2023 FY2022 Y on Y Forecast Achievement Results Results Change (%) Change (Oct. 31) (%) Infectious disease drugs 97.5 82.9 85.1 112.1 (26.0) (29.2) COVID-19 related products ＋ Influenza franchise 88.6 73.4 82.9 103.6 (29.1) (30.2) Excludes purchase of Xoco
Slide 11: Achievements in FY2023
Achievements in FY2023 Achieved revenue and profit growth through top-line growth and meticulous cost management Domestic business: Successfully expanded our own sales mainly in the category of infectious disease drugs Revenue from domestic business increased by 46.5 billion yen from the previous fi
Slide 12: Reflections on First Year of STS2030 Revision Phase2
Reflections on First Year of STS2030 Revision Phase2 The KPIs set forth in the STS2030 Revision have shown a promising start in alignment with the objectives of STS Phase2 STS Phase2 STS Phase3 FY2023 (Target) FY2023 (Results) FY2025 FY2030 Revenue 450.0 B yen 435.1 B yen 550.0 B yen 800.0 B yen Ove
Slide 13: FY2023 fiscal year initiatives and FY2024 outlook: Infectious Diseases
FY2023 fiscal year initiatives and FY2024 outlook Infectious Diseases 13
Slide 14: Ensitrelvir: Summary of Results on the SCORPIO-HR trial
Ensitrelvir: Summary of Results on the SCORPIO-HR trial • Although ensitrelvir demonstrated a numerical reduction in the time to symptom resolution compared to placebo among participants treated within 3 days of symptom onset, the difference was not statistically Primary significant. Symptom improve
Slide 15: Ensitrelvir: Development Direction and Progress of each Clinical Trials
Ensitrelvir: Development Direction and Progress of each Clinical Trials Aiming to provide ensitrelvir globally as an oral antiviral drug with potent antiviral and symptom-improving effects Future development Current status of each clinical trials direction • SCORPIO-PEP trial • Discussions with regu
Slide 16: Toward Further Stabilization of Acute Infectious Disease Business Model
Toward Further Stabilization of Acute Infectious Disease Business Model Aim to realize a “diagnosis and treatment” paradigm with a comprehensive virus treatment portfolio Acute infectious disease business model Importance of “test to treat” • Need to offer multiple infectious disease therapeutics Ep
Slide 17: Addressing the global issue of AMR
Addressing the global issue of AMR Progress in accumulating real-world evidence for cefiderocol and improving global access Published Real-world evidence* Expanding global access • Expansion of cefiderocol (Fetcroja) It is important to build evidence post-marketing suppliers in Europe to evaluate th
Slide 18: Progress of HIV Business by ViiV
Progress of HIV Business by ViiV Our HIV business has made steady progress based on growth of LA formulations* oral two-drug regimens*2 ViiV sales trend of Dolutegravir and Cabotegravir products*3 Growth of oral two-drug （£M） regimens YoY +23.3% 6,265 ￡M 6000 YoY +12.4% • Dovato continues to contrib
Slide 19: CROI 2024 Update
CROI 2024* Update ViiV reported excellent tolerability and safety of CAB-ULA*2 at CROI 2024 Summary of CAB-ULA Phase 1 trial results The future development of CAB-ULA Adminis PrEP*5 Part CAB-ULA dose N tration Endpoints 1 800 mg (2 mL) SC*3 8 • Following the favorable results of the Phase 1 2 800 mg
Slide 20: 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 Pipeline Indication Current stage FY2024 FY2025 COVID-19 S-268019 Submission (Vaccine)
Slide 21: QOL Diseases with High Social Impact
FY2023 fiscal year initiatives and FY2024 outlook QOL Diseases with High Social Impact 21
Slide 22: S-309309 Development Progress
S-309309 Development Progress Top-line disclosure is scheduled for R&D Day Status of progress 2023 2024 2025 Jul. Oct. Apr. Jun. Jan.-Mar. First patient in Currently conducting a one- Phase 3 start month follow-up observation and data analysis (scheduled) Last Patient in 365 cases Completion of dosi
Slide 23: Introduction of MZE001, a New Therapeutic Drug Candidate for Pompe Disease
Introduction of MZE001, a New Therapeutic Drug Candidate for Pompe Disease Aim to cause a paradigm shift by a low-molecular therapeutic drug for Pompe disease whose unmet needs are high What is Pompe disease? Characteristics of MZE001 • A genetic disorder characterized by dysfunction of acid α-gluco
Slide 24: Promoting the global development of treatments for diseases affecting QOL
Promoting the global development of treatments for diseases affecting QOL Progress in global initiatives for pediatric diseases and rare diseases Promote the development of two products Obesity with synergistic effects globally • Development of anti-obesity drug Pediatric・ S-309309 MZE001 zatolmilas
Slide 25: 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 SDT-001
Slide 26: FY2024 Financial Forecasts
FY2024 Financial Forecasts 26
Slide 27: FY2024 Financial Plan
FY2024 Financial Plan While accelerating investments, we will achieve increased revenue and profits through top-line growth • Expand sales of infectious disease drugs in Japan - Improve the presence of Xocova and Xofluza Top-line growth mainly through our • Strong growth of overseas businesses - Inc
Slide 28: Domestic Business Progression in FY2024
Domestic Business Progression in FY2024 Aiming to further grow domestic business by continuously introducing new products to the market Focus items NEW Xocova Daridorexant Insomnia Treatment COVID-19 treatment • Promote early diagnosis and treatment • Aim for continued stable growth as an important
Slide 29: Enhancing Global Sales System
Enhancing Global Sales System Further accelerate globalization by unifying sales systems in both in Japan and overseas FY2023 • Domestic sales ‒ Achieved growth and stabilization of profit with Xocova and the influenza family • Overseas sales FY ‒ Established a presence in the infectious disease are
Slide 30: Initiatives to Become a Globally Competitive Leader
Initiatives to Become a Globally Competitive Leader Strengthening the company platform and human resources in order to be a globally competitive leader Strengthening the company platform Strengthening human resources • Strengthen global corporate functions • Reform of the human resources system - Ch
Slide 31: Financial Results
Financial Results • Both revenue and operating profit are expected to achieve record highs for the third consecutive year Earnings • We plan to increase profits in all profit items forecast - Profit before tax and profits attributable to owners of parent will also post increases • Investment toward
Slide 32: Statement of Profit or Loss
Statement of Profit or Loss (Unit: B yen) FY2024 Forecasts FY2023 Y on Y Full year 1H Result Change (%) Change Revenue 455.0 210.0 435.1 4.6 19.9 Cost of Sales 66.0 28.5 57.6 14.6 8.4 Gross profit 389.0 181.5 377.5 3.1 11.5 Selling, general & administrative expenses, R&D expenses total 226.5 111.0 2
Slide 33: Revenue by Segment
Revenue by Segment (Unit: B yen) FY2024 Forecasts FY2023 Y on Y Full year 1H Result Change(%) Change Prescription drugs 134.9 58.0 151.1 (10.7) (16.2) Overseas subsidiaries/export 53.7 24.7 49.9 7.6 3.8 Shionogi Inc. (US) 20.6 10.0 17.9 15.1 2.7 Shionogi B.V. (EU) 14.4 6.8 13.6 6.1 0.8 Ping An Shion
Slide 34: Prescription Drugs in Japan
Prescription Drugs in Japan (Unit: B yen) FY2024 Forecasts FY2023 Y on Y Full year 1H Result Change(%) Change Infectious disease drugs 91.2 37.6 82.9 9.9 8.2 80.1 32.7 73.4 9.1 6.7 COVID-19 related products ＋ Influenza franchise Symproic 6.5 2.9 4.5 43.9 2.0 OxyContin franchise 5.0 2.3 4.2 20.4 0.8
Slide 35: Shareholder Return
Shareholder Return ® SHIONOGI
Slide 36: Shareholder return policy through which shareholders can feel our growth
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 • FY2023 is the largest annual dividend increase (+25 yen) • Plan to increase dividend again for the 13t
Slide 37: Appendix
Appendix 37 @® snionoai
Slide 38: Progress in Major Development Projects concerning New Products and Businesses
Progress in Major Development Projects concerning New Products and Businesses As of May 12, 2024 Disease area Pipeline Indication Current stage Note Scheduled for deliberation at the Second Pharmaceutical S-268019 COVID-19 (Origin strain vaccine) Submission Subcommittee (May 24, 2024) S-268023 COVID
Slide 39: Pipeline: Infectious Disease
Pipeline: Infectious Disease as of May 12, 2024 Preclinical Phase 1 Phase 2 Phase 3 Submission S-567123 S-337395 S-337395 F901318 Ensitrelvir* Ensitrelvir*2 COVID-19 [Olorofim] RSV infections RSV infections COVID-19 treatment COVID-19 treatment Universal Vaccine Invasive Aspergillosis S-892216 Cefid
Slide 40: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of May 12, 2024 Preclinical Phase 1 Phase 2 Phase 3 Submission S-540956 S-151128 S-309309 S-005151* S-812217 SDT-001 [Redasemtide] [Zuranolone] ADHD Nucleic acid adjuvant Chronic pain Obesity Acute ischemic stroke Depression (pediatric) S-005151 GRT7
Slide 41: Ensitrelvir: Trial Overview
Ensitrelvir： Trial Overview SCORPIO-HR（Global development） SCORPIO-SR ー Trial Overview ー ー Trial Overview ー Outpatient COVID-19 cases, including Subject patients at risk of developing severe Subject Mild to moderate COVID-19 patients illness Target 2,000 cases Number of number of Xocova group : 1,00
Slide 42: S-309309: Profile
Partial changes to SHIONOGI R&D Day 2022 materials S-309309：Profile Indication Mechanism of action • Obesity • Monoacylglycerol transferase 2 (MGAT2) inhibitor Product characteristics • Best-in-class efficacy among existing oral drugs (weight loss of 10% or more per year) with no safety concern Mark
Slide 43: Pathophysiology of Pompe Disease and Treatment Concept with MZE001
Pathophysiology of Pompe Disease and Treatment Concept with MZE001 • Pompe disease is a disorder where a mutation (activity reduction) in the lysosomal acid alpha-glucosidase (GAA) in muscles leads to abnormal accumulation of glycogen in muscle tissues, resulting in tissue destruction • The symptoms
Slide 44: Sustainable Growth Strategy Focusing on LA and ULA Formulations
Sustainable Growth Strategy Focusing on LA and ULA Formulations Growth is expected to continue through and beyond 2026 through sales growth of LA formulations and market launches of ULA* formulations 2021 – 2026 2026 2026 – 2031 Expected to lead the growth of the overall HIV business The overall HIV
Slide 45: 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 Evrey day Treatment 1,819 Two-drug regimens Julu
Slide 46: Building a Robust Global Supply Chain
Building a Robust Global Supply Chain Initiatives to ensure stable supply of antibiotics in Japan through industry-academics-government collaboration Complex problems and issues of SHIONOGI’s initiatives supply shortage of antibiotics Reliance on raw materials and Kanegasaki active pharmaceutical in
Slide 47: Other Major Progress
Other Major Progress* • February − Academic Presentation at Neuroscience 2023 in the United States - Confirmation of Gamma Wave Synchronization in the Human Brain through Auditory Stimulation- − Recognized with the Double A List for Leadership in Corporate Transparency and Performance on Climate Cha
Slide 48: 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