Shionogi & Co., Ltd. · TSE:4507
Shionogi & — H1 FY2023 Earnings Presentation
47 slides from Shionogi &'s earnings presentation, Oct 31, 2023
Slide 1: 1st Half of Fiscal 2023 Financial Results
1st Half of Fiscal 2023 Financial Results October 31, 2023 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda • Overview of 1st Half FY2023 Financial Results (P.3-12) • FY2023 Financial Forecasts (P.13-18) • Shareholder Return (P.19-20) • Updates on COVID-19 Treatment (P.21-24) • Main Activities and Achievements in Pipeline (P.25-33) • Updates on HIV Business (P.34-38) 2
Slide 3: Overview of 1st Half FY2023 Financial Results
Overview of 1st Half FY2023 Financial Results 3
Slide 4: Financial Highlights
Financial Highlights • Revenue and all profit items increased year-on-year, with sales and profits significantly exceeding expectations • Continuing from 1Q, sales revenue and various profits reached record highs in the first half as well Operating Profit Profit attributable to Revenue EBITDA* profi
Slide 5: Financial Results
Financial Results （Unit：B yen） FY2023 FY2022 Y on Y Forecasts 1H Results Achievement (%) 1H Results Change(%) Change Full year 1H Revenue 450.0 217.0 230.5 106.2 150.8 52.9 79.8 Operating profit 150.0 80.5 98.1 121.9 28.2 247.6 69.9 Profit before tax 192.5 98.0 115.6 118.0 68.0 70.1 47.6 Profit attr
Slide 6: Statement of Profit or Loss
Statement of Profit or Loss （Unit：B yen） FY2023 FY2022 Y on Y Forecast 1H Results Achievement (%) 1H Results Change (%) Change Full year 1H Revenue 450.0 217.0 230.5 106.2 150.8 52.9 79.8 15.3 14.5 12.1 18.2 Cost of Sales 69.0 31.5 27.9 88.5 27.4 1.9 0.5 Gross profit 381.0 185.5 202.7 109.2 123.4 64
Slide 7: Main Variation Factors of Profit attributable to owners of parent (Y on Y)
Main Variation Factors of Profit attributable to owners of parent (Y on Y) Revenue ＋33.3 • Increase：Domestic sales, Overseas （B yen） subsidiaries /export, Royalty income 1.5 (22.3) Other income & expenses (14.3) 79.8 • Increase：Costs related to implementation of (10.1) (0.8) (0.5) early retirement p
Slide 8: Revenue by Segment
Revenue by Segment （Unit：B yen） FY2023 FY2022 Y on Y Forecast 1H Results Achievement (%) 1H Results Change (%) Change Full year 1H Prescription drugs 134.1 87.4 96.4 110.2 33.4 188.8 63.0 Overseas subsidiaries/export 96.6 28.0 22.9 81.9 19.9 15.1 3.0 Shionogi Inc.（US） 13.6 6.7 8.1 121.8 7.4 10.3 0.8
Slide 9: Main Variation Factors of Revenue (Y on Y)
Main Variation Factors of Revenue (Y on Y) ＋79.8 Prescription drugs （B yen） 3.0 0.8 0.6 0.0 • Increase : Sales of Xocova and Xofluza 12.3 : Receipt of Lump-sum income for transfer of ADHD drug 63.0 : Returns of Xofluza and Rapiacta in FY2022 (5.3 B yen) • Decrease: Sales of ADHD drug 230.5 Royalty i
Slide 10: Prescription Drugs in Japan
Prescription Drugs in Japan （Unit：B yen） FY2023 FY2022 Y on Y Forecast 1H Results Achievement (%) 1H Results Change (%) Change Full year 1H Infectious disease drugs 65.7 40.0 49.0 122.5 (0.6) - 49.6 COVID-19 related products ＋ Influenza franchise 57.3 35.8 44.4 124.1 (5.0)* - 49.4 Cymbalta 4.2 2.1 2
Slide 11: Top-line grew significantly due to expansion of in-house sales
Top-line grew significantly due to expansion of in-house sales Continuing from 1Q, sales continued to increase in all businesses （B yen） Revenue 230.5 Key drivers of top-line growth ＋79.8 B yen 15.6 250 • Domestic ：Xocova sales strongly drive top-line growth 22.9 ：Strong growth of Influenza franchis
Slide 12: 1st Half Results and Future Outlook
1st Half Results and Future Outlook Steady progress in transforming the company into a company that can expand globally Achieved record highs in sales revenue and all profit items Top-line growth • Significant growth in all businesses (Y on Y) • Revenue and various profit items exceeded budget Progr
Slide 13: FY2023 Financial Forecasts
Overview of 1st Half FY2023 Financial Results 13
Slide 14: Regarding changes in the breakdown of earnings forecasts
Regarding changes in the breakdown of earnings forecasts As top line growth is steady, initial forecasts for revenue and various profit items remain unchanged Selling, general & administrative expenses, Revenue R&D expenses • Sales increase of COVID-19 related products Influenza • Decrease in sellin
Slide 15: Financial Results (FY2023 Forecasts)
Financial Results （Unit：B yen） FY2023 Forecast FY2022 Results Y on Y Full year 2H Full year Change (%) Change Revenue 450.0 219.5 426.7 5.5 23.3 Operating profit 150.0 51.9 149.0 0.7 1.0 Profit before tax 192.5 76.9 220.3 (12.6) (27.8) Profit attributable to owners of parent 155.0 64.4 185.0 (16.2)
Slide 16: Statement of Profit and Loss
Statement of Profit and Loss （Unit：B yen） FY2023 Forecasts Full year FY2023 Forecasts 2H FY2022 Y on Y Forecasts Revised Revised Forecasts Revised Revised Results Change(%) Change (May. 10) （Oct. 31） amount (May. 10) （Oct. 31） amount Revenue 450.0 450.0 - 233.0 219.5 (13.5) 426.7 5.5 23.3 15.3 13.2
Slide 17: Revenue by Segment
Revenue by Segment （Unit：B yen） FY2023 Forecasts Full year FY2023 Forecasts 2H FY2022 Y on Y Forecasts Revised Revised Forecasts Revised Revised Results Change(%) Change (May. 10) （Oct. 31） amount (May. 10) （Oct. 31） amount Prescription drugs 134.1 167.0 32.9 46.7 70.6 24.0 179.7 (7.1) (12.7) Overse
Slide 18: Prescription Drugs in Japan
Prescription Drugs in Japan （Unit：B yen） FY2023 Forecasts Full year FY2023 Forecasts 2H FY2022 Y on Y Forecasts Revised Revised Forecasts Revised Revised Results Change(%) Change (May. 10) （Oct. 31） amount (May. 10) （Oct. 31） amount Infectious disease drugs 65.7 97.5 31.8 25.7 48.5 22.8 112.1 (13.0)
Slide 19: Shareholder Return
Shareholder Return @® snionoai
Slide 20: 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 − Increased dividend by 15 yen from the previous interim period −
Slide 21: Updates on COVID-19 Treatment
Updates on COVID-19 Treatment 21
Slide 22: Xocova: Development Plan
Xocova: Development Plan Promoting development that meets medical and social needs Purpose: Verify the effectiveness of improving clinical symptoms in outpatient COVID- 19 cases, including patients at risk of developing severe illness SCORPIO-HR trial* • Target number of the enrollment : 2,000 cases
Slide 23: Xocova: New Data Announced
Xocova: New Data Announced Effectiveness against Long COVID* Post-Marketing Survey** Results after 1 year of treatment with ensitrelvir • Accumulation of safety and efficacy information from actual • Suggests the possibility of reducing the risk of occurrence use over a long period of time − Safety:
Slide 24: Xocova: New Data Announced
Xocova: New Data Announced Taste and Smell It is a characteristic symptom of COVID-19, and the period of illness tends to be longer than other symptoms disorders Nature Medicine, 2022; 28, 1031-1041 Effectiveness on taste and smell disorders* -Phase 2/3 phase clinical trial Additional analysis of Ph
Slide 25: Main Activities and Achievements in Pipeline
Main Activities and Achievements in Pipeline 25
Slide 26: Progress of Major Development Products
Progress of Major Development Products as of October 30, 2023 Disease area Pipeline Indication Current stage FY2023 FY2024 Note S-268019 COVID-19 (Vaccine) Submission Olorofim Invasive aspergillosis Phase 3 Completion of Phase 3 case registration (4Q) S-337395 RSV infections Phase 1 Phase 1 topline
Slide 27: Progress of Vaccine Development
Progress of Vaccine Development Efforts toward building a sustainable business model are progressing COVID-19 Vaccine Development of new technology • Establish a recombinant protein vaccine platform and aim • Universal vaccine for full-scale supply of vaccines against mutant strains in − Creation of
Slide 28: Strengthen Pipeline by Making Qpex Biopharma a Wholly Owned Subsidiary
Strengthen Pipeline by Making Qpex Biopharma a Wholly Owned Subsidiary As a leading company in infectious diseases, further accelerating efforts to overcome AMR*1 Driving the development of a combination of the β-lactamase inhibitor xeruborbactam with β-lactam antibiotics Combined effect of xeruborb
Slide 29: S-309309: Anti-Obesity Drug Market and Strengths of S-309309
S-309309： Anti-Obesity Drug Market and Strengths of S-309309 An oral agent with a revolutionary mechanism provides an innovative option for the ever- expanding obesity market Anti-obesity drug market in US Differentiating points of S-309309 (MGAT2* inhibitor) 5,000 • Strong inhibition of triglycerid
Slide 30: S-309309: Phase 1 Data Published during Obesity Week
S-309309： Phase 1* Data Published during Obesity Week There were no safety concerns, and the drug showed an excellent PK profile after single and multiple administrations PK profile and Selection of target concentration Summary Good PK profile Plasma Concentration (ng/mL) • Can be administered once
Slide 31: New Focus Research Area: Obstructive Sleep Apnea (OSA)
New Focus Research Area ：Obstructive Sleep Apnea (OSA) • OSA is a QOL disease with high social impact and is at risk of progressing to various diseases • OSA is a disease with high unmet needs as there are no effective pharmacologic treatment options Symptoms Increased risk of developing various dis
Slide 32: New Focus Research Area: Vision for Drug Discovery for OSA Treatment
New Focus Research Area：Vision for Drug Discovery for OSA Treatment We take a multifaceted approach to provide the right treatment options for each patient Unstable breathing Upper airway obstruction (Excessive ventilation response) OSA pathology is mainly formed by a complex interplay of four facto
Slide 33: New Focus Research Area: Established Shionogi-Apnimed Sleep Science, LLC
New Focus Research Area : Established Shionogi-Apnimed Sleep Science, LLC Build a system that enables the creation of solutions according to the four main factors of OSA and address to solve social issues Expertise in OSA Strengths in small molecule drugs • Robust R&D networks in clinical sites • In
Slide 34: Updates on HIV Business
Updates on HIV business @® snionoai
Slide 35: Progress of HIV Business by ViiV: Update on Medium- to Long-Term Strategy
Progress of HIV Business by ViiV: Update on Medium- to Long-Term Strategy* The road to sustainable growth of SHIONOGI’s HIV business has become clearer 1 2021-2026 CAGR upgraded to 6% - 8% (from mid single digit %) 2 Outlook for LA formulation market expansion until 2031 − Treatment: ~30% LA share (
Slide 36: Progress of HIV Business by ViiV: Sustainable Growth Strategy Centered on LA and ULA
Progress of HIV Business by ViiV: Sustainable Growth Strategy Centered on LA and ULA Support short- to long-term growth by increasing sales of three growth drivers and launch of ULA 2021-2026 2026 2026-2031 Expected sales of up to £7bn for the entire HIV business Driving average annual growth rate o
Slide 37: Development of Once Every Four Months Administration Formulation
Progress of HIV Business by ViiV: Development of Once Every Four Months Administration Formulation (CAB 400) Contribute to further QOL improvement by reducing the number of doses per year • >2x half-life when dosed intramuscularly or subcutaneously, enabling every-four-month (Q4M) dosing with the po
Slide 38: Main Milestones for Medium- to Long-Term Growth Drivers
Progress of HIV Business by ViiV: Main Milestones for Medium- to Long- Term Growth Drivers Accelerate medium- to long-term growth with integrase inhibitor-based ULA CY2023 CY2024 CY2025 CY2026 CY2027 CY2028-2030 Q4M Q6M ULA Registrational Q4M Registrational Q6M (PrEP) study file and launch study fil
Slide 39: Appendix
Appendix 39 @® snionoai
Slide 40: Main Variation Factors of Profit attributable to owners of parent (Forecast Comparison)
Main Variation Factors of Profit attributable to owners of parent (Forcast Comparison) Revenue ＋12.6 • Increase：Domestic sales, Overseas （B yen） 3.6 2.3 (0.0) (6.6) subsidiaries /export, Royalty income 4.8 (5.0) 13.5 Selling, general & administrative expenses • Decrease：Selling expenses of ensitrelv
Slide 41: Main Variation Factors of Revenue (Forecast Comparison)
Main Variation Factors of Revenue (Forcast Comparison) ＋13.5 Prescription drugs （B yen） 8.7 0.6 0.3 0.1 (5.1) 8.9 • Increase : Sales of Xocova and Xofluza Royalty income※ 当四半期の特記すべき増減要因 • Increase: Strong sales of ViiV's HIV franchise 217.0 230.5 Overseas subsidiaries/export • Increase: Sales of cef
Slide 42: S-309309: Profile
Partial changes to SHIONOGI R&D Day 2022 materials S-309309：Profile Indication Mechanism of action • Obesity • Monoacylglycerol transferase 2 (MGAT2) inhibitor Product characteristics • Best-in-class efficacy among existing oral drugs (weight loss of 10% or more per year) with no safety concern Mark
Slide 43: S-309309: Trial Overview
Partial changes to SHIONOGI R&D Day 2022 materials and SHIONOGI S-309309：Trial Overview 2023 1Q Financial results materials Phase 1 Single dose trial Phase 2 trial Country U.S. Country U.S. Subject Adults with a BMI of 30 or higher Phase 1 (single/multiple), single-center, randomized, double-blind,
Slide 44: Pipeline: Infectious Disease
Pipeline: Infectious Disease as of October 30, 2023 Preclinical Phase 1 Phase 2 Phase 3 Submission S-337395 Olorofim Ensitrelvir* Ensitrelvir*2 S-872600 [F901318] Influenza nasal vaccine RSV infections COVID-19 treatment COVID-19 treatment Invasive Aspergillosis S-875670 S-892216 Cefiderocol Ensitre
Slide 45: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of October 30, 2023 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 46: Other Major Progress
Other Major Progress* • July − Toward the Establishment of a Supply-Chain System to Secure a Stable Domestic Supply of Antibacterial Drugs －Certification of “Plan for Stable Supply of Antibacterial Substances” by Ministry of Health, Labour and Welfare－ • August − Flomox Fine Granules for children or
Slide 47: 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