Shionogi & Co., Ltd. · TSE:4507
Shionogi & — H1 FY2024 Earnings Presentation
52 slides from Shionogi &'s earnings presentation, Oct 28, 2024
Slide 1: 1st Half of Fiscal 2024 Financial Results
1st Half (Interim period) of Fiscal 2024 Financial Results October 28, 2024 Shionogi & Co., Ltd. 1
Slide 2: Agenda
Agenda Overview of 1st Half (Interim period) FY2024 01 （P.3-12） Financial Results 02 Revision of FY2024 Financial Forecasts （P.13-23） 03 Shareholder Return （P.24-25） 04 Towards the Realization of the 2030 Vision （P.26-45） • Updates on HIV Business • Updates on Acute Respiratory Infection Business •
Slide 3: Overview of 1st Half FY2024 Financial Results
Overview of 1st Half (Interim period) FY2024 Financial Results 3
Slide 4: Highlight
Highlight • The revenue and various profit items exceeded 1H plan • Excluding the one-time payment* from last year (25 billion yen), the top line has increased in revenue Revenue Revenue 214.0 B yen 230.5 B yen 214.0 B yen 1H Achievement (%) 101.9 (Excludes one-time payment*) (205.5 B yen) Operating
Slide 5: Financial Results
Financial Results • The sales revenue and various profit items exceeded the first half plan - The HIV and overseas businesses strongly drove the growth - Costs were as expected, and the development products progressed steadily Summary • In the same period of the previous year, the one-time payment f
Slide 6: Statement of Profit or Loss
Statement of Profit or Loss (Unit：B yen) FY2024 FY2023 Y on Y Main variation Factors (Y on Y) Forecast Achievement 1H Results 1H Results Change (%) Change Full year 1H (%) Revenue 455.0 210.0 214.0 101.9 230.5 (7.2) (16.6) Revenue • Overseas subsidiaries /export 14.5 13.6 14.1 12.1 Increase Cost of
Slide 7: Revenue by Segment
Revenue by Segment (Unit：B yen) FY2024 FY2023 Y on Y Main variation Factors (Y on Y) Forecast Achievement 1H Results 1H Results Change(%) Change Full year 1H (%) Prescription drugs Prescription drugs 134.9 58.0 47.7 82.3 96.4 (50.5) (48.6) Excluding temporary income - - 47.7 - 71.4 (33.1) (23.6) • S
Slide 8: Prescription Drugs in Japan
Prescription Drugs in Japan （Unit：B yen） FY2024 FY2023 Y on Y Achievement Full year 1H 1H Results (%) 1H Results Change(%) Change Infectious disease drugs 91.2 37.6 29.2 77.7 49.0 (40.4) (19.8) COVID-19 related products ＋ Influenza franchise 80.1 32.7 24.9 76.0 44.4 (44.0) (19.6) Symproic 6.5 2.9 2.
Slide 9: Expansion of the HIV Business
Expansion of the HIV Business Continued stable growth each quarter, centered on the growth of oral two drug regimens* and LA formulations*2 Transition of SHIONOGI's HIV royalty income Sales of ViiV’s dolutegravir and cabotegravir products*3 (quarterly) +9.6 B yen 800 80 (M￡) 1,800 600 60 1,500 Trium
Slide 10: Expansion of Overseas Business
Expansion of Overseas Business Steady growth in overseas business, centered on Cefiderocol Sales revenue of overseas ・US subsidiaries/exports (quarterly) Strong YoY growth in cefiderocol sales +2.4 B yen ・EU 150 15 • U.S.: +1.3 billion yen, 38.2% growth • Europe: +0.8 billion yen, 32.6% growth 100 1
Slide 11: Status of Domestic Business (COVID-19)
Status of Domestic Business (COVID-19) Despite falling short of the first-half budget due to a decline in COVID-19 cases, steady sales were achieved through the expanded market share of Xocova COVID-19 patient trends* (Q2) 13.4 Treatment rate for COVID-19*2 While the number of infections 25 has decr
Slide 12: Summary 1H FY2024 Financial Results
Summary 1H FY2024 Financial Results While making aggressive investments, revenue and all profit items have grown beyond expectations HIV and overseas business segments • HIV Business: Continued growth driven by long- acting (LA) formulations robustly driving top-line growth • Overseas subsidiaries B
Slide 13: Revision of FY2024 Financial Forecasts
Revision of FY2024 Financial Forecasts 13
Slide 14: Revision of Financial Forecasts
Revision of Financial Forecasts Upward revision of revenue and all profit items based on strong 1H performance - Revenue - - Revenue - Downward Domestic business Upward HIV business, overseas business and domestic business • 1H sales of COVID-19 related products and influenza family • Increase in HI
Slide 15: Financial Results (Revised Forecasts)
Financial Results • Revenue and operating profit are expected to surpass previous record forecasts - We are expected to achieve record highs for three consecutive terms Summary • All profit items have also been revised upwards - Steady increase in sales revenue and review of various expenses （Unit：B
Slide 16: Statement of Profit and Loss
Statement of Profit and Loss （Unit：B yen） FY2024 Full year FY2024 2H FY2023 Y on Y Revised Revised Forecasts Revised Forecasts Revised Results Change (%) Change amount amount Revenue 455.0 460.0 5.0 245.0 246.0 1.0 435.1 5.7 24.9 14.5 14.6 13.2 Cost of Sales 66.0 67.0 1.0 37.5 36.9 (0.6) 57.6 16.3 9
Slide 17: Revenue by Segment
Revenue by Segment （Unit：B yen） FY2024 Full year FY2024 2H FY2023 Y on Y Revised Revised Forecasts Revised Forecasts Revised Results Change (%) Change amount amount Prescription drugs 134.9 124.7 (10.2) 76.9 77.0 0.1 151.1 (17.5) (26.4) Overseas subsidiaries/export 53.7 57.6 3.9 29.0 29.3 0.3 49.9 1
Slide 18: Prescription Drugs in Japan
Prescription Drugs in Japan （Unit：B yen） FY2024 Full year FY2024 2H FY2023 Y on Y Revised Revised Forecasts Revised Forecasts Revised Results Change (%) Change amount amount Infectious disease drugs 91.2 83.4 (7.8) 53.5 54.1 0.6 82.9 0.5 0.4 COVID-19 related products ＋ Influenza franchise 80.1 72.3
Slide 19: Acute Respiratory Infection Business in the 2H
Regarding the Acute Respiratory Infection Business in the 2H of the Year As a leading company in infectious diseases, aiming to improve the treatment rate for people suffering from COVID-19 Trends in COVID-19 patients and hospitalized patients* Trends in COVID-19 treatment rates*2 (April-September)
Slide 20: Make QOL Diseases the Next Pillar of SHIONOGI
Make "QOL diseases" the Next Pillar of SHIONOGI Starting with the launch of QUVIVIQ, make the QOL disease area a new pillar of SHIONOGI Infectious diseases QOL diseases By achieving a high market share, Establishing QOL diseases, which are less affected by trends, we have established a stable busine
Slide 21: QUVIVIQ: Manufacturing and Marketing Approval Obtained
QUVIVIQ*: Nxera Pharma Japan has Obtained Manufacturing and Marketing Approval All primary and secondary endpoints were achieved in Phase 3 trial in Japan Primary Endpoint: Comparison of changes from baseline to 4 weeks in Positive results from Phase 3 trial in Japan* subjective total sleep time and
Slide 22: QUVIVIQ: Unmet Needs in Insomnia Treatment and Features
QUVIVIQ: Unmet Needs in Insomnia Treatment and Features of QUVIVIQ Potential to Become the Best-in-Class Treatment in the Expanding Insomnia Field by Meeting Unmet Needs Important Unmet Needs in Insomnia Treatment Features of the New Insomnia Treatment, QUVIVIQ • Alleviates excessive Nocturnal awake
Slide 23: QUVIVIQ: Change in Sales Scheme
QUVIVIQ: Change in Sales Scheme QUVIVIQ, which has excellent efficacy and plays a central role in the QOL disease area, will be sold exclusively in Japan Change in Sales Scheme Previous Sales Scheme New Sales Scheme SHIONOGI to Exclusively Handle Sold through Two Channels Distribution and Sales Acti
Slide 24: Shareholder Return
Shareholder Return ® SHIONOGI
Slide 25: Shareholder Return Policy
Shareholder Return Policy through which Shareholders can Feel Our Growth • Implemented a stock split to enhance stock liquidity and broaden the investor base (effective date: October 1, 2024) − Split each share into three shares and revised the forecasted dividend per share to 29 yen − Pre-split equ
Slide 26: Towards the Realization of the 2030 Vision
Towards the Realization of the 2030 Vision Growth Strategy Based on Three Pillars 26
Slide 27: Update of STS2030 Revision Based on Current Growth Rate
Update of STS2030 Revision Based on Current Growth Rate • HIV business has revised its 2025 and 2030 revenue forecast upwards due to growth exceeding expectations for LA formulations and oral two-drug regimens • Further growth in acute respiratory infections business by combining COVID-19 treatment
Slide 28: Towards the Realization of the 2030 Vision
Towards the Realization of the 2030 Vision • Updates on HIV Business • Updates on Acute Respiratory Infection Business • Updates on New products and New businesses 28
Slide 29: Paradigm Shift of Anti-HIV Therapy to Long-Acting Formulations
Progress of the Paradigm Shift of Anti-HIV Therapy: From Oral pills to the Era of Long-Acting Formulations Addressing the unmet needs of people living with HIV (PLHIV) who aspire to achieve a quality of life comparable to healthy individuals Unmet needs in HIV treatment and PrEP for LA Rise of LA fo
Slide 30: Sustainable Growth Strategy by SHIONOGI and ViiV
Sustainable Growth Strategy by SHIONOGI and ViiV* Achieving short- to mid- to long-term growth through the expansion of existing LA formulations2 and the launch of ULA formulations3 2021-2026 2026 2026-2031 Driving average annual growth rate of 6-8% Expected sales of up to £7bn for the entire HIV bu
Slide 31: Growth Strategy for 2026-2031
Sustainable Growth Strategy by SHIONOGI and ViiV: Growth Strategy for 2026-2031 Drive further expansion of the LA formulation market through the launch of new products that meet diverse unmet needs Promising compounds (licensed from SHIONOGI to ViiV) and key milestones Combination Duration Key drugs
Slide 32: Towards the Realization of the 2030 Vision
Towards the Realization of the 2030 Vision • Updates on HIV Business • Updates on Acute Respiratory Infection Business • Updates on New products and New businesses 32
Slide 33: Outlook for the Acute Respiratory Infection Business
Outlook for the Acute Respiratory Infection Business Strengthening the business model through “establishing a disease portfolio" and “promoting early diagnosis and early treatment" Providing solutions for multiple diseases Growth vision for the acute respiratory infection business (Establishing a di
Slide 34: COVID-19: Development Status of Ensitrelvir
COVID-19: Development Status of Ensitrelvir Conducting various clinical trials to drive further growth of ensitrelvir, including indications expansion and global development SCORPIO-HR Assessment of efficacy in outpatients, including Ongoing 6-month follow-up analysis for Long （Global：Phase 3） those
Slide 35: Influenza: Enhancing the Presence of Xofluza
Influenza: Enhancing the Presence of Xofluza Providing a new value of antiviral drugs, 'transmission suppression* as a 'single-dose oral medication' that many patients desire. Complete treatment with Rapid virus elimination Transmission suppression* a single oral dose Time to virus elimination Reduc
Slide 36: Towards the Realization of the 2030 Vision
Towards the Realization of the 2030 Vision • Updates on HIV Business • Updates on Acute Respiratory Infection Business • Updates on New products and New businesses 36
Slide 37: SHIONOGI's COVID-19 Vaccine Portfolio
SHIONOGI's COVID-19 Vaccine Portfolio Promoting the vaccine business through both platform establishment※ and universal vaccine development Project Antigen Status Remarks COVGOZE Wuhan Approval - （FY2024 1Q ） Follow-up data currently being collected S-268023 XBB1.5 Primary endpoint* not achieved (ev
Slide 38: Towards the Realization of a Vaccine Platform
Towards the Realization of a Vaccine Platform - Characteristics of SHIONOGI’s First Vaccine - Over a period of six months to one year, the neutralizing antibody titers remained high compared to pre-vaccination levels Clinical trial data Clinical trial data COVGOZE : Wuhan* S-268023：XBB1.5*2 5120 160
Slide 39: Vaccine Platform: Future Strategies
Towards the Realization of a Vaccine Platform: Future Strategies Aiming to establish a platform as a vaccine expected to induce neutralizing antibodies over the course of one year Clinical trials using the JN.1 strain will commence Centralizing vaccine production functions (scheduled for FY2024 4Q)
Slide 40: Zuranolone: NDA in Japan for Major Depressive Disorder
Zuranolone: New Drug Application (NDA) in Japan for Major Depressive Disorder Based on favorable clinical trial results, submitted NDA in Japan* Primary endpoint: Change from baseline in the total HAM-D17 score*2 on Day 15 Response rate: The percentage of patients whose total HAM-D score*2 improved
Slide 41: Zuranolone: Unmet Needs and Characteristics
Zuranolone: Unmet Needs in Antidepressant Treatment and Characteristics of Zuranolone As a new treatment option, aim to become "a novel therapy, rapid acting therapy for the acute treatment* of depression" Key unmet needs in antidepressant treatment Characteristics of the novel antidepressant zurano
Slide 42: Progress of Major Development Products - Infection diseases
Progress of Major Development Products - Infection diseases - ※ The bar starts from FPI and ends at CSR, Topline results: It is the timing of acquisition, and the timing of disclosure will be considered separately Disease area Pipeline Indication Current stage FY2024 FY2025 Note Preparation for Anal
Slide 43: Progress of Major Development Products - QOL Diseases
Progress of Major Development Products - QOL Diseases with High Social Impact - ※ The bar starts from FPI and ends at CSR, Topline results: It is the timing of acquisition, and the timing of disclosure will be considered separately Disease area Pipeline Indication Current stage FY2024 FY2025 Note SD
Slide 44: Grow with the Two Pillars of Infectious and QOL Diseases
SHIONOGI will Grow with the Two Pillars of Infectious Diseases and QOL Diseases In addition to the stable growth of its infectious disease business, SHIONOGI is seriously committed to tackling QOL diseases Infection Grow with QOL Diseases two pillars Diseases The pillar of SHIONOGI's business The ne
Slide 45: Future of Prescription Drugs in Japan
Future of Prescription Drugs in Japan By establishing the two pillars of "infectious diseases" and "QOL diseases," the domestic business will transition to a growth phase ~2024 -From FY2024 onwards- Infection 【Sales trends of domestic pharmaceutical products*】 diseases Xofluza/Rapiacta Vaccines S-33
Slide 46: Appendix
Appendix 46 @® snionoai
Slide 47: Pipeline: Infectious Disease
Pipeline: Infectious Disease as of October 28 Preclinical Phase 1 Phase 2 Phase 3 Submission S-567123 S-337395 S-337395 Cefiderocol Ensitrelvir* Ensitrelvir*2 COVID-19 Aerobic Gram-negative RSV infections RSV infections COVID-19 treatment COVID-19 treatment Universal vaccine bacterial infection (Ped
Slide 48: Pipeline: QOL Diseases with High Social Impact
Pipeline: QOL Diseases with High Social Impact as of October 28 Preclinical Phase 1 Phase 2 Phase 3 Submission Resiniferatoxin SDT-001 S-540956 S-151128 S-309309 Redasemtide*3 [GRT7039] ADHD Nucleic acid adjuvant Chronic pain Obesity Acute ischemic stroke Pain associated with knee osteoarthritis (pe
Slide 49: Phase 3 Validation Study Design
Phase 3 Validation Study Design Subject Patients with moderate to severe major depressive disorder [Part A] Examination of superiority of Zuranolone over placebo Purpose [Part B] Examination of safety and tolerability of re-administration when necessary Primary Change from baseline in the total HAM-
Slide 50: Anti-HIV drug released by ViiV
Anti-HIV drug released by ViiV Product CY2023 Formulations Compounds Administrations Frequency Indications name Sales (M￡) Cabenuva CAB＋RPV IM injection Q2M (LA) Treatment 708 Long Acting Apretude CAB IM injection Q2M (LA) PrEP 149 Dovato DTG＋3TC Oral Every day Treatment 1,819 Two-drug regimens Julu
Slide 51: Other Major Progress
Other Major Progress* • July - Conclusion of a comprehensive collaboration agreement with Deloitte Tohmatsu Cyber LLC in the field of cybersecurity • September - Published the Integrated Report 2024 • October - Signed a basic agreement with OKUSHIN SYSTEM Co., Ltd., Kaien Co., Ltd., and Daikin Sunri
Slide 52: 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