Shionogi & Co., Ltd. · TSE:4507
Shionogi & — Q3 2022 Earnings Presentation
33 slides from Shionogi &'s earnings presentation, Jan 31, 2023
Slide 1: 3rd Quarter of Fiscal 2022 Financial Results
3rd Quarter of Fiscal 2022 Financial Results January 30, 2023 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda 1. Overview of Q3 FY2022 Financial Results (P.3-8) 2. FY2022 Financial Forecasts (P.9-13) 3. Achievements in Q3 FY2022 and Actions for Future Growth (P.14-21) 2
Slide 3: Overview of Q3 FY2022 Financial Results
1. Overview of Q3 FY2022 Financial Results 3
Slide 4: Financial Results
Financial Results (Unit: B yen) FY2022 FY2021 Y on Y Forecasts Apr.-Dec. Achievement Apr.-Dec. Change Full Year Change Results (%) Results (%) (Oct. 24) Revenue 410.0 338.3 82.5 219.6 54.1 118.7 Operating profit 120.0 146.5 122.1 60.4 142.4 86.1 Core operating profit* 120.0 144.0 120.0 61.9 132.6 82
Slide 5: Statement of Profit or Loss
Statement of Profit or Loss (Unit: B yen) FY2022 FY2021 Y on Y Forecasts Apr.-Dec. Achievement Apr.-Dec. Change Main Variation Factors (Y on Y) Full Year (Oct 24) Results (%) Results (%) Change ※Special Notes for 3Q Revenue 410.0 338.3 82.5 219.6 54.1 118.7 19.5 13.2 18.1 • Revenue Cost of Sales - I
Slide 6: Revenue by Segment
Revenue by Segment (Unit: B yen) FY2022 FY2021 Y on Y Main Variation Factors (Y on Y) Forecasts Achieve Apr.-Dec. Apr.-Dec. Change ※Special Notes for 3Q Full Year ment Change Results Results (%) (Oct 24) (%) • Prescription drugs Prescription drugs 76.4 54.7 71.5 69.5 (21.4) (14.9) - Increase: Sales
Slide 7: Revenue Forecasts for Prescription Drugs in Japan
Revenue Forecasts for Prescription Drugs in Japan (Unit: B yen) FY2022 FY2021 Y on Y Forecasts Apr.-Dec. Achievement Apr.-Dec. Change Full year Change Results (%) Results (%) (Oct 24) Intuniv® 20.0 14.8 74.0 12.1 21.6 2.6 Vyvanse® 1.3 1.1 84.4 0.6 90.1 0.5 Infectious disease drugs 8.8 2.9 32.8 8.8 (
Slide 8: Results and Progress in Q3 FY2022
Results and Progress in Q3 FY2022 Bringing COVID-19 treatment drug Xocova® to patients Outcome from our COVID-19 investment contributed to earnings • Providing new treatment options • Contribution to earnings − Antiviral drugs play an important role in normalizing − Exceeded each profit category in
Slide 9: FY2022 Financial Forecasts
2. FY2022 Financial Forecasts 9
Slide 10: Regarding the Changes in Earnings Forecasts
Regarding the Changes in Earnings Forecasts Key Points of Earnings Forecast Revision • In the initial forecast, the profit contribution of Xocova® was estimated conservatively, but following the emergency approval in Japan, various profit items including operating profit have been revised substantia
Slide 11: Revision of Earnings Forecast
Revision of Earnings Forecast (Unit: B yen) FY2022 Forecasts Full year FY2021 Y on Y Forecasts Forecasts Revised Change Forecasts Results Change (Revised on (Revised on amount (%) (May. 11) Oct. 24) Jan. 30) Revenue 400.0 410.0 421.0 11.0 335.1 25.6 85.9 Operating profit 120.0 120.0 147.0 27.0 110.3
Slide 12: Revision of Earnings Forecast: Statement of Profit and Loss
Revision of Earnings Forecast: Statement of Profit and Loss (Unit: B yen) FY2022 Forecasts Full year FY2021 Y on Y Forecasts Forecasts Revised Change Forecasts Results Change (Revised on (Revised on amount (%) (May. 11) Oct. 24) Jan. 30) Revenue 400.0 410.0 421.0 11.0 335.1 25.6 85.9 22.0 19.5 15.7
Slide 13: Revision of Earnings Forecast: Revenue by Segment
Revision of Earnings Forecast: Revenue by Segment (Unit: B yen) FY2022 Forecasts Full year FY2021 Y on Y Forecasts Forecasts Revised Change Forecasts Results Change (Revised on (Revised on amount (%) (May. 11) Oct. 24) Jan. 30) Prescription drugs 78.6 76.4 76.4 - 89.1 (14.3) (12.7) Overseas subsidia
Slide 14: Achievements in Q3 FY2022 and Actions for Future Growth
3. Achievements in Q3 FY2022 and Actions for Future Growth 14
Slide 15: Xocova: Progress Summary
Xocova®: Progress Summary FY2021 FY2022 FY2023 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 Application for conditional approval (2/25) Trial period: Start of patient enrollment Switch to EUA to completion of clinical trial report Ph 3 part topline results Post acute CO
Slide 16: Xocova: Overall picture of the current situation and future plans
Xocova®: Overall picture of the current situation and future plans With the emergence of new mutant strains, the need for antiviral drugs remains Accumulating various evidence for the role of Xocova® in coexistence with COVID-19 Development Supply Japan Phase 2/3 trial（Japan・Asia） Japan • Pediatric
Slide 17: Xocova: Japan/Global Progress (1)
Xocova®：Japan/Global Progress (1) Japan Global Studies • Supply from govermment purchase, which is different from • SCORPIO-HR normal sales − Aiming for completion in 2023 • Collection and evaluation of safety information − Accelerating patient enrollment by expanding sites − Over 20,000 patients ha
Slide 18: Xocova: Japan/Global Progress (2)
Xocova®：Japan/Global Progress (2) China • Ping An-Shionogi is preparing to apply for NDA − First of all, provide products manufactured in Japan Roles in supply/sales of Xocova® imported from Japan − Switch to domestic production in China as soon as preparations are complete Ping An-Shionogi SHIONOGI
Slide 19: Pipeline progress
Pipeline progress Development updates from 3Q*1 Pipeline Indication Progress S-309309 Obesity Confirmed favorable safety, tolerability and PK profile in Phase 1 interim report Phase 2 trial scheduled to start in 4Q FY2022 Limited treatment options for Olorofim High efficacy and tolerability confirme
Slide 20: Progress of HIV Franchise by ViiV Healthcare
Progress of HIV Franchise by ViiV Healthcare Strong uptake of innovative portfolio and continued pipeline progress • Growth led by Dovato and long-acting regimens • Dovato (two-drug regimen) − Sales of £360 million in Q3 2022 Unit: million £ 【Sales trends of innovative portfolio*1 】 (increase 73% Yo
Slide 21: Progress of HIV Franchise by ViiV Healthcare
Progress of HIV Franchise by ViiV Healthcare Development status of combination candidates for ultra LA injections* From GSK financial results in Q3 2022 Phase 1 Phase 2 VH3739937 VH4004280 VH3640254 VH3810109 (N6LS) maturation inhibitor capsid protein inhibitor maturation inhibitor broadly neutraliz
Slide 22: Appendix
Appendix 22 @® snionosi
Slide 23: Xocova: Antiviral effect against mutant strains
Xocova®: Antiviral effect against mutant strains* In vitro antiviral evaluation using VeroE6T cells gamm omicron strain virus Ancest alpha beta delta a BA.2.7 strain or strain strain strain BA.1 BA.1.1 BA.2 BA.4 BA.5 BQ.1.1 XBB.1 XE strain 5 EC50 0.37 0.46 0.40 0.50 0.41 0.29 0.36 0.52 0.30 0.22 0.4
Slide 24: S-268019: Progress Summary
S-268019: Progress Summary FY2021 FY2022 FY2023 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 Phase 1/2*1 Interim Report (12/6) Phase 2/3*2 (safety/immunogenicity evaluation) Interim Report (4/22) Phase 3*5 (neutralizing antibody titer comparison trial) Phase 2/3*3 (boos
Slide 25: Financial Position (Consolidated, IFRS)
Financial Position (Consolidated, IFRS) Total Assets Equity attributable to owners of parent 1,261.6 (Unit: B yen) 1,150.6 975.7 1,055.2 End of End of Unit: B yen Mar. 2022 Dec. 2022 Change Non-current Total Assets 491.4 512.1 20.7 Assets Current Assets 659.2 749.6 90.3 Equity attributable to owners
Slide 26: Disposal, Acquisition and Cancellation of Treasury Stock
Disposal, Acquisition and Cancellation of Treasury Stock Associated with the Establishment of the New Foundation Disposal of treasury stock Share buyback Cancellation of treasury shares (advantageous issuance) ・ Total number of shares to be acquired: 7.2M（maximum） • Total shares to be cancelled: 4.2
Slide 27: Upcoming Pipeline Events 1/2
From the FY2022 R&D Day Upcoming Pipeline Events 1/2 As of Oct. 12, 2022 Not all plans are listed Pipeline Indication Stage FY2022 3Q-4Q FY2023 FY2024 Ph2b Interim Ph3 Completion of olorofim（F901318） Invasive Aspergillosis Phase 2b、Phase 3 report case registration （3Q） （4Q） S-337395 RSV infection Pr
Slide 28: Upcoming Pipeline Events 2/2
From the FY2022 R&D Day Upcoming Pipeline Events 2/2 As of Oct. 12, 2022 Not all plans are listed Pipeline Indication Stage FY2022 3Q-4Q FY2023 FY2024 ①Preparing for additional Submission clinical trial ① ①Epidermolysis bullosa （3Q） ②Preparing for Phase 3 trial ②Acute ischemic stroke redasemtide ③④I
Slide 29: Pipeline: Infectious Disease
Pipeline: Infectious Disease as of January. 30, 2023 Preclinical Phase 1 Phase 2 Phase 3 Submission S-872600 S-540956 S-217622* S-217622 *2 ［Ensitrelvir］ ［Ensitrelvir］ Influenza nasal vaccine Nucleic acid adjuvant COVID-19 treatment COVID-19 treatment *,*3 Phase 2/3, Phase 3 *2 Korea S-875670 S-3373
Slide 30: Pipeline: Psycho-Neurological Disease, Pain
Pipeline: Psycho-Neurological Disease, Pain as of January. 30, 2023 Preclinical Phase 1 Phase 2 Phase 3 Submission S-874713 S-600918 S-600918 S-600918 S-812217 Psycho-neurological [sivopixant] [sivopixant] [sivopixant] [zuranolone] diseases Neuropathic pain Refractory chronic cough Refractory chroni
Slide 31: Pipeline: New Growth Areas
Pipeline: New Growth Areas as of January. 30, 2023 Preclinical Phase 1 Phase 2 Phase 3 Submission S-005151 S-488210 S-540956 S-770108 S-588410 Nucleic acid adjuvant Idiopathic pulmonary [redasemtide] Head and neck squamous Esophageal cancer Acute ischemic stroke cell carcinoma S-005151 S-588210 S-58
Slide 32: Other Major Progress
Other Major Progress* • November − Entering Into a Capital Alliance Agreement with LIFESCAPES − SHIONOGI Integrated Report 2022 Won Silver Award in the WICI Japan Integrated Report Award 2022 • December − Shionogi Recognized with Double A list for Leadership in Corporate Transparency and Performance
Slide 33: 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