Shionogi & Co., Ltd. · TSE:4507
Shionogi & — FY2020 Earnings Presentation
48 slides from Shionogi &'s earnings presentation, May 10, 2021
Slide 1: FY2020 Financial Results
FY2020 Financial Results (April 2020 – March 2021) May 10, 2021 Isao Teshirogi, Ph.D. President and CEO
Slide 2: Agenda
Agenda 1. Overview of FY2020 Financial Results (P.4-13) 2. Actions and Financial Forecasts in FY2021 (P.15-27) 3. Shareholder Return (P.29) 2
Slide 3: 1. Overview of FY2020 Financial Results
1. Overview of FY2020 Financial Results 3
Slide 4: Financial Results (Consolidated)
Financial Results (Consolidated) (Unit：B yen) FY2020 FY2019 Y on Y Forecasts Achievement Change Change (Revised on Results Results* (%) (%) (B yen) Feb. 1) Revenue 301.4 297.2 98.6 333.4 (10.9) (36.2) Operating profit 122.9 117.4 95.6 130.6 (10.1) (13.2) Core operating profit** 97.7 94.0 96.1 127.4
Slide 5: Statement of Profit or Loss (Consolidated)
Statement of Profit or Loss (Consolidated) (Unit: B yen) FY2020 FY2019 Y on Y Forecasts Achievement Change Change (Revised on Results Results* (%) (%) (B yen) Feb. 1) Revenue 301.4 297.2 98.6 333.4 (10.9) (36.2) 18.1 17.7 17.0 Cost of sales 54.5 52.5 96.4 56.8 (7.5) (4.3) Gross profit 246.9 244.7 99
Slide 6: Main Variation Factors (Statement of Profit or Loss)
Main Variation Factors (Statement of Profit or Loss) Main Variation Factors (Y on Y) • Y on Y comparison (Unit: B yen) • Revenue - Decrease in domestic prescription drugs business Revenue (36.2) - Decrease in overseas business (US: one-time payment Cost of sales (4.3) received in FY2019) - Decrease
Slide 7: Revenue by Segment
Revenue by Segment (Unit: B yen) FY2020 FY2019 Y on Y Forecasts Achievement Change Change (Revised on Results Results* (%) (%) (B yen) Feb. 1) Domestic Prescription drugs 98.3 94.7 96.3 106.3 (10.9) (11.6) Overseas subsidiaries/export 24.5 24.6 100.5 30.8 (20.0) (6.2) Shionogi Inc. 7.0 7.5 107.0 10.
Slide 8: Revenue of Prescription Drugs in Japan
Revenue of Prescription Drugs in Japan (Unit: B yen) FY2020 FY2019 Y on Y Forecasts Achievement Change Change (Revised on Results Results* (%) (%) (B yen) Feb. 1) Cymbalta® 27.4 26.5 96.4 26.2 0.9 0.2 Intuniv® 14.0 13.1 93.6 10.6 22.8 2.4 Vyvanse®** 0.5 0.3 59.7 0.0 － 0.3 Infectious disease drugs 10
Slide 9: Main Variation Factors (Revenue by Segment)
Main Variation Factors (Revenue by Segment) • Y on Y comparison Main Variation Factors (Y on Y) (Unit: B yen) • Domestic Prescription drugs Revenue - Increase in sales of Intuniv® in FY2019 333.4 - Decrease in sales of infectious disease drugs and impact of price revision Contract • Overseas subsidi
Slide 10: Actions and Achievements in FY2020: Leading Company in Infectious Disease
Actions and Achievements in FY2020 As a Leading Company in Infectious Disease Action for total care of COVID-19 • Progressed development of recombinant protein vaccines using BEVS technology. • Conducting Phase 1/2 trials in Japan • Alliances for early detection of COVID-19 incursion and outbreak Pr
Slide 11: Promotion of R&D: Core Projects
Actions and Achievements in FY2020 Promotion of R&D : Core 8 Projects Pipeline Indication Initial target for FY2020 Status Infectious disease S-540956 HIV infection, cancer Initiation of Phase 1 study in 4Q FY2020 Changed to 1Q FY2021 ①Phase 2b topline results are anticipated ①Refractory chronic cou
Slide 12: Progress in Overseas Business
Actions and Achievements in FY2020 Progress in Overseas Business US and Europe: Maximized value of cefiderocol • Promote both antimicrobial stewardship and infectious disease business growth – US: Additional indication approval and designation for NTAP* – Europe: Sales growth in 5 countries (UK, Swe
Slide 13: Review of FY2020 - Looking ahead to FY2021
Review of FY2020 - Looking ahead to FY2021 - Progress of business transformation in FY2020 Actions for Growth of Advancement of total care of overseas core 8 projects COVID-19 business In COVID-19-related R&D, we were unable to respond to the expectations of society as a leading company of infectiou
Slide 14: 2. Actions and Financial Forecasts in FY2021
2. Actions and Financial Forecasts in FY2021 14
Slide 15: Shionogi's Commitment in FY2021
Shionogi’s Commitment in FY2021 As a leading company in the infectious disease field Shionogi will work intensively to counter the COVID-19 pandemic as our highest priority 15
Slide 16: Current Issues and What Shionogi Wants to Achieve
Current Issues and What Shionogi Wants to Achieve Small-molecule therapeutics Safe and effective Prevention Diagnosis Treatment treatments Asymptomatic person Vaccination Lumira* Recuperation at home Rapid, easy and highly sensitive Mild patient diagnosis Recuperation at a non-medical facility SATIC
Slide 17: Business Environment Surrounding Shionogi
Business Environment Surrounding Shionogi (COVID-19 related) As society's need for an early end to the pandemic grows ever greater, the business environment is changing at an unprecedented speed Vaccines Hopes for a purely domestic vaccine ⇒ Expectations for domestic vaccines due to prolonged COVID-
Slide 18: Development and Stable Supply of Domestic Vaccines
Development and Stable Supply of Domestic Vaccines Actions for the introduction of purely domestic vaccines Development / production status Key factors influencing launch date • Conducting Ph1/2 trials in Japan • Difficulty in conducting large- – Confirmed no major safety concerns – Preparing for Ph
Slide 19: Development of Therapeutic Drugs with Superior Efficacy and Safety
Development of Therapeutic Drugs with Superior Efficacy and Safety Drug discovery power for antiviral drugs + modalities • Changes in external environment surrounding COVID-19 drug development – While the development of therapeutic drugs is progressing using various modalities, the number of discont
Slide 20: Suppression of Exacerbations in Asymptomatic Individuals and Mild Patients
Suppression of Exacerbations in Asymptomatic Individuals and Mild Patients Responding to exacerbation risk using existing assets • BioAge began Ph2 trials of asapiprant – Asapiprant: discovered by Shionogi as S-555739 – Prostaglandin D2 DP1 receptor antagonist developed as allergic rhinitis drug; pr
Slide 21: Identify Patients at Risk of Exacerbation
Identify Patients at Risk of Exacerbation Diagnostic markers that can predict exacerbation • HISCL® TARC* reagent – It is difficult to ascertain patients who have the risk of exacerbation in the early stages of COVID-19, and the risk of healthcare system collapse due to increased patient hospitaliza
Slide 22: Early Prediction of Pandemic
Early Prediction of Pandemic Establishment of analysis system for SARS-CoV-2 in sewage • Periodic monitoring of SARS-CoV-2 accumulation in sewage treatment plants and facility sewage makes it possible to obtain epidemiological information at the population level • Collaboration with Hokkaido Univers
Slide 23: To Avoid Continual Social Anxiety Caused by Infectious Diseases
To Avoid Continual Social Anxiety Caused by Infectious Diseases Strengthen preparations for the next pandemic • Accurate prediction of pandemics is difficult (COVID-19, flu, etc.) • While the spread of COVID-19 has certainly raised public awareness of infectious diseases, crisis management for the n
Slide 24: Business Plan in FY2021
Business Plan in FY2021 In addition to the COVID-19-related business, which is expected to undergo rapid evolution*, 2021 will be a year with abundant new business opportunities Expand infectious disease-related Acquire new growth drivers business • Providing COVID-19 related products and services:
Slide 25: Financial Forecasts
Financial Forecasts (Unit: B yen) FY2021 Forecasts FY2020 Y on Y Change Change Full year 1H Results (%) (B yen) Revenue 290.0 135.0 297.2 (2.4) (7.2) Operating profit 90.0 38.5 117.4 (23.4) (27.4) Core operating profit* 90.0 38.5 94.0 (4.2) (4.0) Profit before tax 115.0 48.5 143.0 (19.6) (28.0) Prof
Slide 26: Statement of Profit or Loss Forecast
Statement of Profit or Loss Forecast (Unit: B yen) FY2021 forecasts FY2020 Y on Y Change Change Full year 1H Results (%) (B yen) Revenue 290.0 135.0 297.2 (2.4) (7.2) 19.8 18.5 17.7 Cost of sales 57.5 25.0 52.5 9.5 5.0 Gross profit 232.5 110.0 244.7 (5.0) (12.2) Selling general & 30.7 32.6 32.0 admi
Slide 27: Revenue Forecast by Segment
Revenue Forecast by Segment (Unit: B yen) FY2021 forecasts FY2020 Y on Y Change Change Full year 1H Results (%) (B yen) Domestic Prescription drugs* 94.4 46.1 94.7 (0.3) (0.3) Overseas subsidiaries/export 31.1 12.2 24.6 26.2 6.5 Shionogi Inc. 8.4 4.2 7.5 12.5 0.9 Ping An-Shionogi**/C&O 14.3 3.9 10.1
Slide 28: 3. Shareholder Return
far yout _ 3. Shareholder Return @® SHIONOGI 28
Slide 29: 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 Plan to increase dividend again in FY2021 for the tenth consecu
Slide 30: As a Company Needed by Society
As a Company Needed by Society ー Shionogi‘s commitment in FY2021 － As a leading company in the infectious disease field Shionogi will work intensively to counter the COVID-19 pandemic as our highest priority Material issues to create new value for customers and society Protect people • Develop infec
Slide 31: Appendix
for you! Appendix @ SHIONOGI
Slide 32: Financial Position (Consolidated, IFRS)
Financial Position (Consolidated, IFRS) Total Assets Equity attributable to owners of parent (Unit: B yen) 999.0 End of End of Unit: B yen Change 873.7 846.1 Mar. 2020 Mar. 2021 765.2 Total Non-current 357.7 442.8 85.1 Assets Assets Current Assets 516.0 556.2 40.2 Equity attributable to 765.2 846.1
Slide 33: Business Impact of COVID-19
Business Impact of COVID-19 Impact of COVID-19 on 3Q FY2020 and Our Response • Supply chain – Continue to procure overseas imported raw materials ahead of schedule and secure inventories, and increased monitoring of manufacturing of active pharmaceutical ingredients (APIs) and products by suppliers
Slide 34: FY2020 Pipeline Target Milestones
FY2020 Pipeline Target Milestones Phase Pipeline Indication Milestone : achieved Submission~ Fetroja® (cefiderocol) Nosocomial pneumonia* US: supplemental approval Approval Aerobic Gram-negative Fetcroja® (cefiderocol) EU: Approval bacterial infection* Influenza virus infection Xofluza®granules Japa
Slide 35: Pipeline: Infectious Disease
Pipeline: Infectious Disease as of May 10, 2021 Preclinical Phase 1 Phase 2 Phase 3 Submission S-872600 S-268019* Xofluza® Influenza prophylactic COVID-1 prophylactic Influenza virus infection vaccine vaccine (Granules, < 20 kg) * Phase 1/2 on-going ：Global development S-648414 cefiderocol HIV infec
Slide 36: Pipeline: Psycho-neurological Disease
Pipeline: Psycho-neurological Disease as of May 10, 2021 Preclinical Phase 1 Phase 2 Phase 3 Submission S-874713 S-600918 S-812217 Psycho-neurological diseases Neuropathic pain [zuranolone] Depression Out license S-872881 S-010887 Alzheimer's dementia Neuropathic pain S-600918 S-0373** [sivopixant]
Slide 37: Pipeline: New Growth Area
Pipeline: New Growth Area as of May 10, 2021 Preclinical Phase 1 Phase 2 Phase 3 Submission S-531011 S-770108 S-237648 S-588410 Solid tumor Idiopathic pulmonary fibrosis Obesity Esophageal cancer S-540956 S-723595 S-588410 Nucleic acid adjuvant NASH Bladder cancer S-309309 SR-0379 Obesity Cutaneous
Slide 38: Key Events for Major Pipeline Compounds
Key Events for Major Pipeline Compounds as of May 10, 2021 Pipeline Mar. 2020 FY2020 FY2021 FY2022 S-648414 Ph1 Ph2a start HIV infection on-going （undecided） S-540956 Non-clinical Ph1 start Ph1 topline results HIV infection, cancer （1Q） （4Q） Ph1/2 start S-268019 Non-clinical （4Q） COVID-19 prophylact
Slide 39: Key Events for Major Pipeline Compounds
Key Events for Major Pipeline Compounds as of May 10, 2021 Pipeline Mar. 2020 FY2020 FY2021 FY2022 zuranolone Ph2 Ph2 topline results Depression start （2Q） S-600918 Ph2b Ph2b topline results Refractory chronic cough on-going （1Q） S-600918 Ph2a Ph2a topline results Sleep apnea syndrome start Ph1 topl
Slide 40: Key Events for Major Pipeline Compounds
Key Events for Major Pipeline Compounds as of May 10, 2021 Pipeline Mar. 2020 FY2020 FY2021 FY2022 redasemtide Sponsor investigator Launch Epidermolysis bullosa top-line results Ph2 Ph2 topline results redasemtide on-going （3Q） Ischemic stroke Ph1 start S-531011 Non-clinical （2Q） Solid tumor S-58841
Slide 41: Revenue Forecasts for Prescription Drugs in Japan
Revenue Forecasts for Prescription Drugs in Japan (Unit: B yen) FY2021 forecasts FY2020 Y on Y Change Change Full year 1H Results (%) (B yen) Cymbalta® 15.1 10.0 26.5 (42.9) (11.3) Intuniv® 18.2 8.5 13.1 39.5 5.2 Vyvanse® 1.0 0.4 0.3 288.1 0.8 Infectious disease drugs 17.0 4.8 9.8 74.4 7.3 Influenza
Slide 42: Providing New Diagnostic Methods
Providing New Diagnostic Methods Meet Medical Needs Rapid and highly sensitive antigen test • LumiraDx SARS-CoV-2 Ag Test Strip* – An antigen test that overcomes the issues of speed in PCR test and sensitivity in antigen test > Diagnostic results similar to those from PCR can be easily obtained in 1
Slide 43: Providing New Value by Ping An-Shionogi
Providing New Value by Ping An-Shionogi FY2021 action • Strengthen sales alliances with online medical platforms – Expand product range > Increased range of C&O products and Shionogi Healthcare’s products > Introducing products (GE, OTC) suited to online prescription – Expand sales channels > Develo
Slide 44: Providing new value by Ping An-Shionogi
Providing new value by Ping An-Shionogi Actions for Medium to long term increase in corporate value AI drug discovery research Smart factories • Use AI technology to search • Apply AI technology to for candidate compounds pharmaceutical that broadly act on the target manufacturing to automate genes
Slide 45: Building a foundation for new value creation
Actions and Achievements in FY2020 Building a foundation for new value creation Pursued advanced decision making and cost structure reform Education and training for all Advanced decision making based managers: on management and business Project KANAME strategies 1) Understanding of new medium-term
Slide 46: Realization of growth phase through cost structure reform
Actions in FY2020 Realization of growth phase through cost structure reform Software and hardware reforms implemented in FY2020 For current businesses Capability to add future businesses Focus that ensures a high rate of return Invest to generate a high rate of return Ability to adjust and manage Va
Slide 47: Material Issues to Be Tackled by Shionogi
Material Issues to Be Tackled by Shionogi Material issues determined in light of • Protect people worldwide from the threat external/internal changes in environment of infectious diseases Extremely high – Develop infectious-disease-related products and distribute accurate information about them – Bi
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