Shionogi & Co., Ltd. · TSE:4507
Shionogi & — FY2022 Earnings Presentation
44 slides from Shionogi &'s earnings presentation, May 10, 2023
Slide 1: FY2022 Financial Results
FY2022 Financial Results May 10, 2023 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda 1. Overview of FY2022 Financial Results (P.3-12) 2. Actions and Financial Forecasts in FY2023 (P.13-28) 3. Shareholder Return (P.29-30) 2
Slide 3: Overview of FY2022 Financial Results
1. Overview of FY2022 Financial Results 3
Slide 4: Financial Highlights
Financial Highlights Revenue and all profit categories exceeded record highs Revenue：426.7 B yen（ 420.2 B yen ：FY2001） Profit before tax：220.3 B yen（ 174.0 B yen：FY2018） Operating profit：149.0 B yen（ 145.1 B yen：FY2018） Profit attributable to owners of parent ：185.0 B yen（ 137.2 B yen：FY2018）
Slide 5: Financial Results
Financial Results (Unit: B yen) FY2022 FY2021 Y on Y Forecasts Achievement Change revised on Results Results Change (%) (%) Jan.30 Revenue 421.0 426.7 101.4 335.1 27.3 91.5 Operating profit 147.0 149.0 101.4 110.3 35.1 38.7 Core operating profit* 144.5 158.5 109.7 110.6 43.3 47.9 Profit before tax 2
Slide 6: Statement of Profit or Loss
Statement of Profit or Loss (Unit: B yen) FY2022 FY2021 Y on Y Forecasts Achievement Change Results Results Change Jan.30 (%) (%) Revenue 421.0 426.7 101.4 335.1 27.3 91.5 15.7 14.6 16.5 Cost of Sales 66.0 62.2 94.3 55.4 12.3 6.8 Gross profit 355.0 364.4 102.7 279.7 30.3 84.7 Selling, general & admi
Slide 7: Statement of Profit or Loss (Y on Y)
Statement of Profit or Loss（Y on Y） -500 -50 0 500 50 100 1,000 (Unit: B yen) Main Variation Factors (Y on Y*) • Revenue Revenue 売上収益 91.5 -Increase: COVID-19 related products Overseas subsidiaries/export Cost売上原価 of Sales 6.8 -Decrease: Prescription drugs Gross 売上総利益profit 84.7 • Cost of Sales Sell
Slide 8: Revenue by Segment
Revenue by Segment (Unit: B yen) FY2022 FY2021 Y on Y Forecasts Achievement Change Results Results Change Revised on Jan. 30 (%) (%) Prescription drugs 76.4 75.0 98.2 89.1 (15.8) (14.1) Overseas subsidiaries/export 39.3 42.5 108.1 34.4 23.7 8.1 Shionogi Inc. (US) 14.4 15.4 107.0 13.8 12.2 1.7 Fetroj
Slide 9: Revenue by Segment (Y on Y)
Revenue by Segment（Y on Y） (Unit: B yen) FY2021 Revenue 335.1 B yen Main Variation Factors (Y on Y*) COVID-19 related products • COVID-19 related products ＋104.7 -Increase: Purchase of 2 million courses of Xocova by the Japanese government Overseas subsidiaries/export : Sales of Xocova in Japan thro
Slide 10: 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 (%) (Jan 30) Intuniv 20.0 19.2 96.1 16.4 17.0 2.8 Vyvanse 1.3 1.4 112.3 0.8 81.2 0.6 Infectious disease drugs 8.8 7.4 84.7 11.8 (
Slide 11: FY2022 Results for Medium-Term Business Plan STS2030 KPIs
FY2022 Results for Medium-Term Business Plan STS2030 KPIs KPI FY2019 FY2020 FY2022 FY2022 FY2024 FY2030 (Result) (Result) (Target) (Results) Revenues 333.4 B yen 297.2 B yen 400.0 B yen 426.7 B yen Achieved 500.0 B yen 600.0 B yen Growth indications Core operating profit* 127.4 B yen 94.0 B yen 120.
Slide 12: Results for FY2022
Results for FY2022 Progress of COVID-19 A paradigm shift in Development of projects the HIV franchise growth drivers • Domestic commercialization • Extension of HIV franchise due • Shifted resources from of Xocova, building to rapid growth of long-acting COVID-19 to other growth foundations for glob
Slide 13: Actions and Financial Forecasts in FY2023
2. Actions and Financial Forecasts in FY2023 13
Slide 14: Direction for FY2023
Direction for FY2023 Accelerating global expansion with the new infectious disease products created in FY2022 Top-line growth through Establishment of growth drivers global sales expansion that can be deployed globally • Expand sales of Xocova in Japan and Asia • Aggressive investment to advance glo
Slide 15: Earnings Forecast
Earnings Forecast (Unit: B yen) FY2023 Forecasts FY2022 Y on Y Change Full year 1H Results Change (%) Revenue 450.0 217.0 426.7 5.5 23.3 Operating profit 150.0 80.5 149.0 0.7 1.0 Core operating profit* 150.0 80.5 158.5 (5.4) (8.5) Profit before tax 192.5 98.0 220.3 (12.6) (27.8) Profit attributable
Slide 16: Forecast: Revenue by Segment
Forecast: Revenue by Segment (Unit: B yen) FY2023 Forecasts FY2022 Y on Y Change Full year 1H Results Change (%) Prescription drugs 134.1 87.4 179.7** (25.4) (45.6) Overseas subsidiaries/export 96.6 28.0 42.5 127.3 54.1 Shionogi Inc. (US) 13.6 6.7 15.4 (11.7) (1.8) Shionogi BV (EU) 11.5 5.4 9.1 27.2
Slide 17: Global Top-line Growth
Global Top-line Growth Achieve top-line growth through our own sales of Xocova in Japan, expansion overseas, and growth of base business Revenue Forecast by Segment ( Y on Y) (Unit: B yen) 450.0 426.7 • Forecast includes 105.0 B yen in Xocova and COVID-19 Proceeds from the vaccine sales purchase of
Slide 18: Xocova (Ensitrelvir): Global Expansion
Xocova (Ensitrelvir): Global Expansion* In fiscal 2023, we seek to establish clear growth in Japan and obtain approval and start commercialization in Asia, mainly in China and Korea Japan：Start of general distribution and transition to category 5 infectious diseases US/UK,EU • Creating an environmen
Slide 19: Xocova (Ensitrelvir): Latest Data from Phase 3 Part of Phase 2/3 Trial
Xocova (Ensitrelvir): Latest Data* from Phase 3 Part of Phase 2/3 Trial Positive date, attributed to strong antiviral effects, continue to be generated Reduced risk of Long COVID manifestation*2 Regarding viral rebound and symptom recurrence*3 • Significantly reduced risk of manifestation of Long •
Slide 20: Vaccine Business: Building a New Business Foundation
Vaccine Business: Building a New Business Foundation Establish vaccines as a medium- to long-term growth driver, including domestic launch of S-268019 COVID-19 vaccine: S-268019 Establishment of a production system for recombinant protein vaccines • Under review by MHLW and PMDA for approval • Initi
Slide 21: Cefiderocol: Countermeasure against AMR
Cefiderocol: Countermeasure against AMR*, an issue that must be addressed on a global scale Accelerate advanced actions for a sustainable acute infectious disease business model Actions to improve access • Expand launched countries and ensure broader understanding of Countries covered by partnership
Slide 22: Progress of HIV Business by ViiV
Progress of HIV Business by ViiV Paradigm shift due to growth of oral 2-drug regimens and LA formulations and accelerating of next-generation pipeline development (£M) ViiV sales trend of innovative portfolio* 60% Further growth of top line 1,000 Dovato Juluca Cabenuva Apretude 48% 49% • Dovato: Dri
Slide 23: Direction of Domestic Business
Direction of Domestic Business Continue to expand sales and portfolio for sustainable growth in focus areas FY2023 FY2024 – FY2025 Maximize the value of existing products Launch of new growth drivers S-268019 Zuranolone Xocova Xofluza COVID-19 Depression COVID-19 treatment Influenza virus infection
Slide 24: Milestones of Major Development Products
Milestones of Major Development Products Selection and concentration on growth drivers addressing unmet medical needs Disease area Pipeline Indication FY2022 FY2023 FY2024 Olorofim Invasive aspergillosis Phase 3 Phase 3 Completion of case registration （4Q） Infection S-337395 RSV infections Phase 1 P
Slide 25: Earnings Forecast
Repost of P.15 Earnings Forecast (Unit: B yen) FY2023 Forecasts FY2022 Y on Y Change Full year 1H Results Change (%) Revenue 450.0 217.0 426.7 5.5 23.3 Operating profit 150.0 80.5 149.0 0.7 1.0 Core operating profit* 150.0 80.5 158.5 (5.4) (8.5) Profit before tax 192.5 98.0 220.3 (12.6) (27.8) Profi
Slide 26: Forecast: Statement of Profit and Loss
Forecast: Statement of Profit and Loss (Unit: B yen) FY2023 Forecasts FY2022 Y on Y Change Full year 1H Results Change (%) Revenue 450.0 217.0 426.7 5.5 23.3 15.3 14.5 14.6 Cost of Sales 69.0 31.5 62.2 10.8 6.8 Gross profit 381.0 185.5 364.4 4.5 16.6 Selling, general& 50.9 47.7 47.8 administrative e
Slide 27: Forecast: Revenue by Segment
Repost of P.16 Forecast: Revenue by Segment (Partially revised) (Unit: B yen) FY2023 Forecasts FY2022 Y on Y Assumptions for forecasts Change Full year 1H Results Change • Prescription drugs (%) ‒ Sales revenue of Xocova and COVID-19 Prescription drugs 134.1 87.4 179.7 (25.4) (45.6) vaccine in Japan
Slide 28: Forecasts: Prescription Drugs in Japan
Forecasts: Prescription Drugs in Japan (Unit: B yen) FY2023 Forecasts FY2022 Y on Y Change Full year 1H Results Change (%) Infectious disease drugs 65.7 40.0 112.1 (41.4) (46.4) Covid-19 related products ＋ Influenza franchise 57.3 35.8 103.6 (44.7) (46.3) Cymbalta 4.2 2.1 5.4 (23.5) (1.3) OxyContin
Slide 29: Shareholder Return
3. Shareholder Return @® snionoai
Slide 30: Flexible and Prompt Capital Strategy
Flexible and Prompt Capital Strategy • 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 − FY2022 is the largest annual dividend increase (+20 yen) − Plan
Slide 31: Appendix
Appendix 31 @® snionoai
Slide 32: Statement of Profit or Loss (Forecast Comparison)
Statement of Profit or Loss （Forecast Comparison） -5 -150 -5 -50 5 50 10 150 (Unit: B yen) Revenue 売上収益 5.7 (3.8) Main Variation Factors （vs. Forecasts） 売上原価 Cost of Sales Gross profit 売上総利益 9.4 • Revenue - Increase: Overseas subsidiaries/export, Royalty income Selling, general& 販売費・一般管理費 (1.5) admi
Slide 33: Revenue by Segment (Forecast Comparison)
Revenue by Segment（ Forecast Comparison ） 10 -100 -5 -50 0 5 50 10 100 (Unit: B yen) 3,351億円 Prescription drugs 国内医療用医薬品 (1.4) Overseas, Main Variation Factors （vs. Forecasts） 海外子会社/輸出 subsidiaries/export ＋3.2 • Royalty income (HIV franchise) Contract manufacturing 製造受託 ＋0.6 - Increase: Strong sales
Slide 34: Financial Position (Consolidated, IFRS)
Financial Position (Consolidated, IFRS) Total Assets Equity attributable to owners of parent 1,311.8 (Unit: B yen) 1,150.6 1,100.0 975.7 End of End of Unit: B yen Mar. 2022 Mar 2023 Change Non-current Total Assets 491.4 527.6 36.2 Assets Current Assets 659.2 784.2 125.0 Equity attributable to owners
Slide 35: 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 shares to be disposed: 3M shares ・ Total number of shares to be acquired: 7.2M share
Slide 36: Xocova (Ensitrelvir): Overall Picture of the Current Situation and Future Plans
From the 3rd Quarter of Xocova (Ensitrelvir): Overall Picture of the Current Fiscal 2022 Financial Results Situation and Future Plans (Partially revised) With the emergence of new mutant strains, the need for antiviral drugs remains Accumulating further evidence for the role of Xocova in “with COVID
Slide 37: R&D: Progress of Future Growth Driver in FY2022
R&D: Progress of Future Growth Driver in FY2022 Disease area Pipeline Origin Indication FY2021 FY2022 Olorofim F2G Invasive aspergillosis Phase 3 Infection S-337395 In house RSV infections Preclinical Phase 1 S-892216 In house COVID-19 Research Phase 1 Psychiatry/ Resiniferatoxin Grünenthal Pain ass
Slide 38: Pipeline: Infectious Disease
Pipeline: Infectious Disease as of May 10, 2023 Preclinical Phase 1 Phase 2 Phase 3 Submission S-872600 F901318 S-217622* S-217622*2 S-337395 [Olorofim] [Ensitrelvir] [Ensitrelvir] Influenza nasal vaccine RSV infections Invasive Aspergillosis COVID-19 treatment COVID-19 treatment *,*3 Phase 2/3、Phas
Slide 39: Pipeline: Psycho-Neurological Disease, Pain
Pipeline: Psycho-Neurological Disease, Pain as of May 10, 2023 Preclinical Phase 1 Phase 2 Phase 3 Submission BPN14770 BPN14770 S-812217 S-109802 S-151128 Post-stroke spasticity Chronic pain [Zatolmilast] [Zatolmilast] [Zuranolone] Alzheimer’s disease Alzheimer’s disease Depression Rizmoic* GRT7039
Slide 40: Pipeline: New Growth Areas
Pipeline: New Growth Areas as of May 10, 2023 Preclinical Phase 1 Phase 2 Phase 3 Submission S-005151 S-540956 S-588210 S-309309 S-588410 Nucleic acid adjuvant Solid tumor Obesity [Redasemtide] Esophageal cancer Acute ischemic stroke S-005151 S-531011* SR-0379 [Redasemtide] Cutaneous ulcer * Phase 1
Slide 41: Improved External Evaluation
Improved External Evaluation FY2018 FY2019 FY2020 FY2021 FY2022 Climate change：C Climate change：A- Climate change：A- Climate change：A Climate change：A- CDP Water Security： Water Security：A Water Security：A- Water Security：A Water Security：A Non-response Supplier Engagement Leader Supplier Engagement
Slide 42: Various Initiatives for HaaS Company
Various Initiatives for HaaS Company Delivering value by providing healthcare as a service （Healthcare as a Service：HaaS*） • Creation of Medical supplies • Vaccine business - Strength of SHIONOGI - Creation of COVID-19 vaccine - Research and development of a nasal • insomnia therapeutic app vaccine
Slide 43: Other Major Progress
Other Major Progress* • February − Associate Professor Masaaki Kitajima et al. Received Committee Special Award for the theme of "Practical application of COVID-19 sewage epidemiological survey" in Japan Open Innovation Prize（JOIP） − Forming of a Joint Venture with Accenture Co., Ltd. Accompanied by
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