Shionogi & Co., Ltd. · TSE:4507
Shionogi & — Q3 FY2023 Earnings Presentation
27 slides from Shionogi &'s earnings presentation, Jan 31, 2024
Slide 1: 3rd Quarter of Fiscal 2023 Financial Results
3rd Quarter of Fiscal 2023 Financial Results January 31, 2024 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda • Overview of Q3 FY2023 Financial Results (P.3-9) • Achievements in Q3 FY2023 and Actions for Future Growth (P.10-20) − Current Status of SHIONOGI’s Infectious Disease Business − Progress of Major Development Products 2
Slide 3: Overview of Q3 FY2023 Financial Results
Overview of Q3 FY2023 Financial Results 3
Slide 4: Financial Results
Financial Results (Unit: B yen) FY2023 FY2022 Y on Y Forecasts Apr.-Dec. Achievement Apr.-Dec. Change Full year Change Results (%) Results (%) (Oct. 31) Revenue 450.0 336.8 74.8% 338.3 (0.5) (1.5) Operating profit 150.0 138.7 92.5% 146.5 (5.3) (7.7) Profit before tax 192.5 164.5 85.4% 198.8 (17.3) (
Slide 5: Expansion of In-house Sales Centered on Infectious Disease Drugs
Expansion of In-house Sales Centered on Infectious Disease Drugs Exceeded the previous year's revenue in all business segment (excluding temporary factors) due to sales growth of in-house developed infectious disease drugs Revenue by Segment (Y on Y) (Unit: B yen) 338.3 336.8 Temporary income 25.0 f
Slide 6: Statement of Profit or Loss
Statement of Profit or Loss (Unit: B yen) FY2023 FY2022 Y on Y Main Variation Factors (Y on Y) Forecast Full year Apr.-Dec. Achievement Apr.-Dec. Change Change Revenue Results (%) Results (%) (Oct. 31) • Increase Revenue 450.0 336.8 74.8 338.3 (0.5) (1.5) − Overseas subsidiaries /export, Royalty inc
Slide 7: Revenue by Segment
Revenue by Segment (Unit: B yen) Main Variation Factors (Y on Y) FY2023 FY2022 Y on Y Forecast Apr.-Dec. Achieveme Apr.-Dec. Change Prescription drugs Full year nt Change Results Results (%) (Oct. 31) (%) • Increase Prescription drugs 167.0 127.5 76.4 154.7 (17.5) (27.1) − Sales of Xocova and Xofluz
Slide 8: Prescription Drugs in Japan
Prescription Drugs in Japan (Unit: B yen) FY2023 FY2022 Y on Y Forecast Apr.-Dec. Apr.-Dec. Full year Achievement (%) Change (%) Change Results Results (Oct. 31) Infectious disease drugs 97.5 69.0 70.8 102.9 (32.9) (33.8) COVID-19 related products ＋ Influenza franchise 88.6 62.0 70.0 96.2 (35.6) (34
Slide 9: Results and Progress in Q3 FY2023
Results and Progress in Q3 FY2023 Achieved expansion of in-house sales centered on infectious disease drugs while accelerating investment to achieve global sales expansion and to advance growth drivers Results up to Q3 FY2023 Activities in Q4 FY2023 • Revenue and all profit items made steady progres
Slide 10: Achievements in Q3 FY2023 and Actions for Future Growth
Achievements in Q3 FY2023 and Actions for Future Growth • Current Status of SHIONOGI’s Infectious Disease Business • Progress of Major Development Products 10
Slide 11: Strategies for the Infectious Disease Business
Reposted of Medium-Term Business Plan SHIONOGI Strategies for the Infectious Disease Business Transformation Strategy 2030 (STS2030) Revision Establish a business model for each area to achieve continuous growth Contribute to global health and stable supply Build a sustainable business model Acute i
Slide 12: Acute Infectious Diseases: Establishment of Sustainable Business
Acute Infectious Diseases: Establishment of Sustainable Business Having a multi-drug respiratory infectious disease portfolio can increase the stability of the business Acute Infectious disease epidemic status in Japan Either influenza or COVID-19 continued to spread above a certain level Trends in
Slide 13: Acute Infectious Diseases (Influenza): SHIONOGI's Anti-influenza Drugs
Acute Infectious Diseases (Influenza): SHIONOGI’s Anti-influenza Drugs Contribute to flu treatment by providing anti-flu drugs with different routes of administration Xofluza: Cap-dependent endonuclease inhibitor Rapiacta: Neuraminidase inhibitor • Indications: Treatment and prevention of influenza
Slide 14: Acute Infectious Diseases (COVID-19): Xocova Development Plan
Acute Infectious Diseases (COVID-19): Xocova Development Plan Advance development for adult and pediatric treatment globally and for obtaining prevention indication Progress of clinical trials Current status in each country • SCORPIO-HR trial: The enrollment was completed in December 2023 • US: − Th
Slide 15: Antimicrobial Resistance (AMR): Cefiderocol
Antimicrobial Resistance (AMR): Cefiderocol Advancing appropriate use while resolving global access issues Ensure broader understanding of appropriate use in Expansion of supply countries through partnering already launched countries and expand launched countries • Europe and America • Conclusion of
Slide 16: Total Care, including Vaccines: Progress of Vaccine Development
Total Care, including Vaccines: Progress of Vaccine Development Establishing a platform*, Commercial manufacturing, Next generation vaccine, are progressing S-268023 (Omicron XBB1.5 strain vaccine) Vaccine antigen commercial manufacturing • Domestic phase 3 booster immunization trial started • Const
Slide 17: Infectious Diseases Requiring a Long Period of Treatment (HIV): Progress of HIV Business by ViiV
Infectious Diseases Requiring a Long Period of Treatment(HIV) : Progress of HIV Business by ViiV HIV business is strong due to growth in oral two-drug regimens*1 and LA formulations*2 ViiV sales trend of oral two-drug regimens and LA formulations*3 Growth in oral two-drug regimens and LA (£M) formul
Slide 18: Progress of Major Development Products
Progress of Major Development Products as of January 30, 2024 Disease area Pipeline Indication Current stage FY2023 FY2024 Note S-268019 COVID-19 (Vaccine) Submission Ensitrelvir COVID-19 Submission, Phase 3 SCORPIO-HR registration completed COVID-19 COVID-19 Start Phase 3 S-268023 Phase 3 Phase 3 t
Slide 19: S-309309 (MGAT2 inhibitor) Development Progress
S-309309 (MGAT2* inhibitor) Development Progress Phase 2 trial progressing as planned Trial Overview** Status of progress Country The U.S. 2023 2024 Subject Adults with a BMI of 30 or higher Jul. Oct. Apr. Apr.-June. Multicenter, randomized, double-blind, dose-ranging, Trial design placebo-controlle
Slide 20: Further Strengthening R&D Capabilities in the Infectious Disease Field
Further Strengthening R&D Capabilities in the Infectious Disease Field Through Qpex, a wholly owned subsidiary, we have expanded our capabilities Evolution of infectious disease R&D Progress of two development products • Enhanced global R&D capabilities S-649228: xeruborbactam＋cefiderocol − Smooth c
Slide 21: Appendix
Appendix 21 @® snionosi
Slide 22: Pipeline: Infectious Disease
Pipeline: Infectious Disease as of January 30, 2024 Preclinical Phase 1 Phase 2 Phase 3 Submission S-872600 S-337395 S-337395 F901318 Ensitrelvir* Ensitrelvir*2 [Olorofim] Influenza nasal vaccine RSV infections RSV infections COVID-19 treatment COVID-19 treatment Invasive Aspergillosis S-875670 S-89
Slide 23: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of January 30, 2024 Preclinical Phase 1 Phase 2 Phase 3 Submission S-540956 S-151128 S-309309 S-005151* S-812217 [Redasemtide] [Zuranolone] Nucleic acid adjuvant Chronic pain Obesity Acute ischemic stroke Depression S-005151 GRT7039 S-109802 S-588210
Slide 24: Other Major Progress
Other Major Progress* • November − The Sales Partnership Agreement in Japan between Shionogi and Mochida regarding Insomnia Treatment Drug Daridorexant − Investment with J.P. Morgan Asset Management’s Life Sciences Private Capital − Stream-I, Inc. Launches New Home Palliative Care Support Service 'H
Slide 25: Creation of Universal Vaccine Antigens
Reposted of 10th Mizuho Bio Conference Creation of Universal Vaccine Antigens Aiming to create vaccine antigens that are effective for novel variant strains and even the next pandemic Design of universal antigens Evolutional tree of coronavirus ACE-2 independent • Design a novel antigen using back-c
Slide 26: Shionogi Pharma's Efforts to Increase Production of Medicon
Shionogi Pharma’s Efforts to Increase Production of Medicon Response so far Number of tablets production of Medicon • Adjustments to bring forward the delivery date of active pharmaceutical ingredients 4.5 [Long term] Addition of manufacturing 4 Responses from January to March 2024 (4Q of 2023) faci
Slide 27: 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