Shionogi & Co., Ltd. · TSE:4507
Shionogi & — Q1 FY2024 Earnings Presentation
30 slides from Shionogi &'s earnings presentation, Jul 29, 2024
Slide 1: 1st Quarter of Fiscal 2024 Financial Results
1st Quarter of Fiscal 2024 Financial Results July 29, 2024 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda 01 Overview of Q1 FY2024 Financial Results （P.3-13） 02 Pipeline Progress （P.14-23） 2
Slide 3: Overview of Q1 FY2024 Financial Results
Overview of Q1 FY2024 Financial Results 3
Slide 4: Highlight
Highlight Excluding the transient factors* of the fiscal year 2023, both the top line and operating profit have increased Operating Topline profit 109.3 B yen 97.6 B yen 46.6 B yen 28.1 B yen (Excludes transient factors ) (84.3 B yen) (Excludes transient factors ) (21.6 B yen) (Unit: Byen) (Unit: By
Slide 5: Financial Results
Financial Results • Revenue and various profit items have landed above expectations compared to the first half plan - The overseas business and HIV business, which have grown as revenue bases, are also making steady progress this term - Since April, the domestic share of Xocova has expanded rapidly
Slide 6: Statement of Profit or Loss
Statement of Profit or Loss （Unit：B yen） FY2024 FY2023 Y on Y Main Variation Factors (Y on Y) Forecast Apr.-Jun. Achievement Apr.-Jun Change (%) Change Full year 1H Results (%) Results 売上収益 Revenue Revenue 455.0 210.0 97.6 46.5 109.3 (10.7) (11.7) 14.5 13.6 14.8 12.0 • Royalty income 増加 Cost of Sale
Slide 7: Revenue by Segment
Revenue by Segment （Unit：B yen） FY2024 FY2023 Y on Y Main Variation Factors (Y on Y) Forecast Apr.-Jun Achievement Apr.-Jun Change(%) Change Full year 1H Results (%) Results Prescription drugs Prescription drugs 134.9 58.0 15.4 26.6 45.9 (66.4) (30.5) Excluding temporary income - - 15.4 - 20.9 (26.2
Slide 8: Expansion of the HIV Business
Expansion of the HIV Business Continued stable growth each quarter, centered on the growth of LA formulations* Sales of ViiV's Dolutegravir and Cabotegravir Transition of HIV royalty income product groups*2 800 80 +15.5 B yen (M￡) 1600 600 60 1200 Triumeq Tivicay B yen 400 40 54 800 Apretude 213 24
Slide 9: Expansion of Overseas Business
Expansion of Overseas Business Steady growth in overseas business, centered on Cefiderocol Sales revenue of overseas Sales of Cefiderocol are growing strongly subsidiaries/exports (quarterly) in both the US and EU +3.0 B yen 150 15 • An increase of over 45% compared to the same period of the previou
Slide 10: Acute Respiratory Infection portfolio - COVID-19 and influenza -
Acute Respiratory Infection portfolio - COVID-19 and influenza - Achieved strong revenue in the first quarter with two infectious disease drug assets The infection status of COVID-19 and influenza* 40 Sales of the influenza family are almost zero 35 1Q 2Q 3Q 4Q 1Q 2Q 30 Influenza COVID-19 related pr
Slide 11: Oral COVID-19 treatment prescription rates change
Oral COVID-19 treatment prescription rates change No significant decrease in prescription rates even after public funding ended in April Transition of oral COVID-19 treatment prescription rates since February 2024* (Weekly) 15 • Steady prescription rate is maintained even after the end 11.7 of publi
Slide 12: COVID-19 oral treatment drug share
COVID-19 oral treatment drug share The first quarter landed as expected, and the share of Xocova is expected to expand, making the first half forecast achievable Share of oral treatment drugs for COVID-19 patients* (Weekly) 100% • Among the three oral 90% treatment drugs, Xocova 80% share is on an i
Slide 13: Results and Outlook for Q1 of FY2024
Results and Outlook for Q1 of FY2024 Given the solid performance of the HIV and overseas businesses, the first half forecast is expected to be achieved The revenue drivers, HIV business and overseas • HIV business: +15.5 billion yen (Y on Y) business, continue to grow • Overseas business: +3.0 billi
Slide 14: Pipeline Progress
Pipeline Progress ® SHIONOGI
Slide 15: S-309309: Next Steps
S-309309：Next Steps Focus on unmet medical needs remaining with, or created by, GLP-1 receptor agonists Unmet needs after broad uptake of GLP-1 Future Policy receptor agonists (GLP-1 RAs) Reduction in the dosage (and Expanded preclinical program supporting corresponding side effects and cost of clin
Slide 16: New Clinical Data on Ensitrelvir in Japan
New Clinical Data on Ensitrevir in Japan Accumulation of real-world evidence confirmed ensitrevir's effectiveness in reducing severe outcomes and its favorable safety and efficacy* Effectiveness of ensitrelvir in reducing Post-Marketing Survey －Final analysis report－ severe outcomes Retrospective tr
Slide 17: Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes
Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes shown Using a large Japanese Health Insurance Claims Database* Administration of ensitrelvir reduces the risk of hospitalization in patients with high-risk for severe disease Cumulative hospitalization (after IPTW Trial Overview Res
Slide 18: Development Status of Ensitrelvir
Development Status of Ensitrelvir Leading Company in Infectious Diseases, Conducting Various Clinical Trials to Address COVID-19 Issues SCORPIO-HR Assessment of efficacy in outpatients, including • Results of the Phase 3 trial were presented at IAS 2024* （Global：Phase 3） those with risk factors for
Slide 19: SCORPIO-HR Trial: Efficacy regarding symptom resolution
SCORPIO-HR Trial：Efficacy regarding symptom resolution Time to resolution of 15 COVID-19 symptoms was shortened, regardless of the presence or absence of risk factors for severe disease Symptom Number of Restricted mean symptom duration*9 (Days) SCORPIO-SR trial Number of COVID- - same analysis 19 s
Slide 20: SCORPIO-HR Trial: Antiviral Activity and Future Directions
SCORPIO-HR Trial：Antiviral Activity and Future Directions Strong antiviral activity, with no observed rebound in viral titers associated with symptoms ー Changes in viral RNA levels* ー ー Antiviral effects* ー SCORPIO-HR trial SCORPIO-SR Trial SCORPIO-HR Trial Ensitrelvir Placebo 2 7 7 VC population* V
Slide 21: Progress of HIV Business by ViiV: New Data Presentation at AIDS2024
Progress of HIV Business by ViiV：New Data Presentation at AIDS2024 Positive Data Supporting New Product Adoption and Progress of Next-Generation Development Products Direct Comparison Study Between Dovato and Biktarvy* Development Progress of S-365598 (ULA*2)*3 Primary Non-inferior Antiviral Efficac
Slide 22: 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 Disease area Pipeline Indication Current stage FY2024 FY2025 Note COVGOZE COVID-19 App
Slide 23: 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 Note SD
Slide 24: Appendix
Appendix 24 @® snionosi
Slide 25: Prescription Drugs in Japan
Prescription Drugs in Japan （Unit：B yen） FY2024 FY2023 Y on Y Forecast Apr.-Jun. Achievement Apr.-Jun. Change(%) Change Full year 1H Results (%) Results Infectious disease drugs 91.2 37.6 6.1 16.2 9.3 (34.4) (3.2) COVID-19 related products ＋ Influenza franchise 80.1 32.7 3.9 11.9 7.1 (44.9) (3.2) Sy
Slide 26: Pipeline: Infectious Disease
Pipeline: Infectious Disease as of July 29, 2024 Preclinical Phase 1 Phase 2 Phase 3 Submission S-567123 S-337395 Cefiderocol Ensitrelvir* Ensitrelvir*2 COVID-19 S-337395 RSV infections RSV infections AMR (Gram-negative COVID-19 treatment COVID-19 treatment Universal Vaccine bacteria infection) S-89
Slide 27: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of July 29, 2024 Preclinical Phase 1 Phase 2 Phase 3 Submission S-540956 S-151128 S-309309 S-005151*3 S-812217 SDT-001 [Redasemtide] [Zuranolone] ADHD Nucleic acid adjuvant Chronic pain Obesity Acute ischemic stroke Depression (pediatric) S-005151 GR
Slide 28: 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 Every day Treatment 1,819 Two-drug regimens Julu
Slide 29: Other Major Progress
Other Major Progress* • May • Conclusion of the Basic Business Contract with Two Connect Co., Ltd. for Educational and Awareness Activities on the Actual Situation and Challenges of "Allergic Diseases“ • Selected as a "DX Notable Company 2024" for the Second Consecutive Year • Receives an Additional
Slide 30: 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