Slide 1: Conference on FY2024 Financial Results and Reboot 2027
Conference on FY2024 (April 1, 2024 to March 31, 2025) Financial Results and Reboot 2027 - Reboot for a Strong Sumitomo Pharma - Toru Kimura, President and CEO Sumitomo Pharma Co., Ltd May 13, 2025
Slide 2: Disclaimer Regarding Forward-looking Statements
Disclaimer Regarding Forward-looking Statements This material contains forecasts, projections, goals, plans, and other forward-looking statements regarding the Group’s financial results and other data. Such forward-looking statements are based on the Company’s assumptions, estimates, outlook, and ot
Slide 3: Agenda
Agenda Financial Results for FY2024 Financial Forecasts for FY2025 Research and Development Reboot 2027 - Reboot for a Strong Sumitomo Pharma - I. Review of FY2023-2024 II. Reboot of Sumitomo Pharma III. Business Strategy IV. R&D Initiatives V. Summary Q&A © Sumitomo Pharma Co., Ltd. All R
Slide 4: Financial Results for FY2024
Financial Results for FY2024 © Sumitomo Pharma Co., Ltd. All Rights Reserved. 3
Slide 5: Financial Results for FY2024 (Core Basis)
Financial Results for FY2024 Financial Results for FY2024 (Core Basis) Billions of JPY Change FY2024 FY2023 FY2024 Revenue increased primarily due Jan. 31 Results Results Value FX impact % to the growth of three key products forecasts Revenue 314.6 398.8 84.3 15.5 26.8 381.0 In addition to the e
Slide 6: Revenue of Major Products in North America
Financial Results for FY2024 Revenue of Major Products in North America Change ORGOVYX® and GEMTESA® FY2023 FY2024 Change FY2023 FY2024 revenue have grown beyond initial Results Results Results Results FX forecasts Value % Million $ impact Initial Results ％ North America Millions of USD Billions o
Slide 7: Revenue of Major Products in Japan & Asia
Financial Results for FY2024 Revenue of Major Products in Japan & Asia Billions of JPY Change FY2023 FY2024 Results Results Value ％ Japan Japan Equa®/EquMet® 30.6 24.9 (5.7) (18.7) Equa® revenue decreased due to its LATUDA® 11.7 13.2 1.4 12.1 loss of exclusivity TWYMEEG® 4.6 7.6 3.1 66.9 LATUDA®
Slide 8: Joint Venture of Asia Business and Transfer of Frontier Business
Financial Results for FY2024 Joint Venture of Asia Business and Transfer of Frontier Business Allocating the necessary growth investments for the Asia business and Frontier business is currently difficult Strategic investments in growth areas will be strengthened Joint Venture of Asia Business T
Slide 9: Financial Forecasts for FY2025
Financial Forecasts for FY2025 © Sumitomo Pharma Co., Ltd. All Rights Reserved. 8
Slide 10: Financial Forecasts for FY2025 (Core Basis)
Financial Forecasts for FY2025 Financial Forecasts for FY2025 (Core Basis) Revenue: Billions of JPY Japan (¥14.1B) : LOE of Equa®/EquMet® FY2024 FY2025 Change North America (¥3.6B) : Despite the revenue Results Forecasts Value FX impact % increase in USD, it is expected to decrease in JPY due
Slide 11: Segment Information (Core Basis) Forecasts
Financial Forecasts for FY2025 Segment Information (Core Basis) Billions of JPY Japan North America Asia Total Japan Revenue 85.7 248.2 21.1 355.0 Despite the SG&A expense reduction, core Cost of sales 46.0 92.1 7.9 146.0 segment profit is expected to decrease given the Forecasts 39.7 156.1 13.2 2
Slide 12: Core Operating Profit Increase/Decrease Factors
Financial Forecasts for FY2025 Core Operating Profit Increase/Decrease Factors Billions of JPY MYFEMBREE® Gain on transfer deferred revenue - Decrease in profit of existing business Transfer of shares in + Profit from supply to NewCo regenerative cell + Gain on equity method business Equa®/EquMet® L
Slide 13: Revenue of Major Products in North America
Financial Forecasts for FY2025 Revenue of Major Products in North America Change FY2024 FY2025 FY2024 FY2025 Change Results Forecasts Results Forecasts Value FX impact % North America Millions of USD Billions of JPY ORGOVYX® 544 710 166 83.1 103.0 19.9 (5.4) 24.0 ORGOVYX® and GEMTESA® revenue are
Slide 14: ORGOVYX
Financial Forecasts for FY2025 ORGOVYX® Volume: Significantly outperformed by $112M more than Forecast due to FY2024 Performance the implementation of patient out-of-pocket cap in Medicare Part D as part of the Inflation Reduction Act, and reduction of the cap started FY2024 Initial Forecast FY202
Slide 15: MYFEMBREE
Financial Forecasts for FY2025 MYFEMBREE® FY2024 Performance Volume: Underperformed by $37M due to the slower growth for oral Year-over-year GnRH in the women’s health sector and slower market share growth in FY2024 Initial Forecast FY2024 Results endometriosis comparison $84M Approx. Price: Alm
Slide 16: GEMTESA
Financial Forecasts for FY2025 GEMTESA® FY2024 Performance Volume: Underperformed relative to initial forecast by $48M, due to Year-over-year changes in Medicare Part D coverage starting in 2025 FY2024 Initial Forecast FY2024 Results Price: Significantly outperformed by $99M driven by Medicare P
Slide 17: GEMTESA prescriptions in β-3 market
Financial Forecasts for FY2025 GEMTESA® Despite the launch of Mirabegron generics in April 2024, the total number of GEMTESA® prescriptions and new prescriptions continued to increase. However, since January 2025, there has been a slightly decline due to changes in Medicare Part D coverage and oth
Slide 18: Research and Development
Research and Development © Sumitomo Pharma Co., Ltd. All Rights Reserved. 17
Slide 19: Major Topics in Clinical Development
Research and Development Major Topics in Clinical Development Psychiatry & Neurology (Regenerative medicine/cell therapy) Allogeneic iPS cell-derived dopaminergic neural progenitor cells (Japan, collaboration with RACTHERA) • Parkinson’s disease Preparing for NDA submission in FY2025 based on th
Slide 20: iPS cell-derived dopaminergic neural progenitor cells: investigator-initiated study results
Research and Development Regenerative Medicine/Cell Therapy: Allogeneic iPS cell-derived dopaminergic neural progenitor cells(CT1-DAP001/DSP-1083) Results of the Investigator-Initiated Study(Announcement by Kyoto University Hospital) Improvement of motor symptoms Modified by the Company from Sawamot
Slide 21: Oncology: enzomenib (DSP-5336) Acute Leukemia
Research and Development Oncology: enzomenib（DSP-5336）Acute Leukemia Ph1 Dose Optimization Ph2 (Registrational) 200mg BID Recommended Ph1 Dose Escalation Dose R/R AML, ALL 300mg BID 300mg BID 400mg BID BID: Twice Daily ︓Currently Ongoing R/R: Relapsed/Refractory AML: Acute Myeloid Leukemia ALL: Acut
Slide 22: Oncology: nuvisertib (TP-3654) Myelofibrosis
Research and Development Oncology: nuvisertib（TP-3654）Myelofibrosis Ph1 Dose Escalation Monotherapy Cohort Determination of Recommended Ph2 Dose Expansion Ph3 JAK Inhibitors Dose Combination Therapy Cohort ︓Currently Ongoing Advance of Clinical Development Presentation at Academic Conference Promo
Slide 23: Reboot 2027 - Reboot for a Strong Sumitomo Pharma
Reboot 2027 - Reboot for a Strong Sumitomo Pharma - © Sumitomo Pharma Co., Ltd. All Rights Reserved.
Slide 24: I. Review of FY2023-2024
I. Review of FY2023-2024 © Sumitomo Pharma Co., Ltd. All Rights Reserved. 23
Slide 25: Review of FY2023-2024: Measures to address LOE of LATUDA
1. Review of FY2023-2024 Insufficient and unsuccessful measures to address the LOE of LATUDA® led to a significant decline in performance in FY2023. Core operating profit and final profit returned to profitability in FY2024 by formulating and implementing fundamental structural reforms Until FY2023
Slide 26: Streamlining, Selection and Concentration
2. Initiatives for FY2023-2024 (PL Management through Fundamental Structural Reforms) Implemented PL management through significant company-wide cost reductions and revision of R&D investment strategy A) Thorough cost reduction and significant workforce Selection and Concentration reduction 6,987 Ja
Slide 27: II. Reboot of Sumitomo Pharma
II. Reboot of Sumitomo Pharma © Sumitomo Pharma Co., Ltd. All Rights Reserved. 26
Slide 28: Reboot for a Strong Sumitomo Pharma
1. Reboot 2027 Reboot for a “Strong Sumitomo Pharma” Work to strengthen our platform as an R&D-driven pharmaceutical company while continuing with selective, focused investment and governance reforms Pave the way for revival by rebuilding the Value Creation Cycle based on internal innovation “Reboot
Slide 29: Our Vision: Global Specialized Player (GSP)
2. Our Vision: Global Specialized Player（GSP） Continue to create and implement innovations in society by strongly turning the Value Creation Cycle in specific fields and technologies. Establish the “Sumitomo Pharma” brand worldwide by contributing to healthy and fulfilling lives Continuously create
Slide 30: To Rebuild the Value Creation Cycle
3. To Rebuild the Value Creation Cycle Major milestones in the rebuilding of the Value Creation Cycle will be concentrated over the next three years The entire company will work together to achieve these milestones through selection and concentration, as well as through external partnerships Major m
Slide 31: Rebuilding the Value Creation Cycle from FY2025 to FY2027
4. Rebuilding the Value Creation Cycle from FY2025 to FY2027 Stabilize the revenue base by expanding the business of the three key products (operating base not dependent on one-time revenues) Rebuild the Value Creation Cycle by commercializing regenerative medicine/cell therapy and oncology Three ke
Slide 32: Milestones for FY2025
5. Milestones for FY2025 Advance the development of two oncology compounds, possibly through partnerships, and submit and obtain approval for iPSC-PD in Japan. FY2025 is the “year to show our true value” as we work to achieve the goals to reinvigorate ourselves as an R&D-driven pharmaceutical compan
Slide 33: Financial Targets
6. Financial Targets By FY 2027 Sales of 3 key Expand to 250 billion yen* products *LATUDA® in NA PL Consistently more than 25 billion yen, Core operating FY22 * profit excluding one-time factors (from FY2027) FY23 3 Key Maintain profitability(FY2025-2027) CF Free cash flow → Return to profitability
Slide 34: Financial Targets (2)
6. Financial Targets (2) The management of interest-bearing debt through FY2027 will depend on the transfer income from the Asia business. Stable free CF from the core business is expected to return to profitability during the period, but key financial events lie ahead → Seeking further financial im
Slide 35: III. Business Strategy
III. Business Strategy © Sumitomo Pharma Co., Ltd. All Rights Reserved. 34
Slide 36: Overview of Business Strategies
1. Overview of Business Strategies Establish a P&L base by maximizing the value of existing products, with a focus on the three key products, and thorough cost management Maintain free CF and acquire the next revenue base by selection and concentration of the development pipelines Maximize the value
Slide 37: For the Early Launch of the Two Oncology Products
2. For the Early Launch of the Two Oncology Products This will be given a top priority as the flagship program for realizing the R&D-driven pharmaceutical company. Given financial constraints, maximize value by developing the products as quickly as possible through leveraging partnerships Promote fo
Slide 38: Expansion of the Regenerative Medicine/Cell Therapy Business
3. Expansion of the Regenerative Medicine/Cell Therapy Business As a “front-runner” in regenerative medicine/cell therapy, create new value that can only be realized through regenerative medicine Aim to expand sales to a maximum of approximately 350 billion yen*1 in the second half of the 2030s Esta
Slide 39: Regional Strategies
4. Regional Strategies Focus on Japan, which has the pharmaceutical business platform including drug discovery research, and North America, the largest market. For the organizational operations in Japan and the US, consider the balance between strengthening cooperation and delegating authority accor
Slide 40: IV. R&D Initiatives
IV. R&D Initiatives © Sumitomo Pharma Co., Ltd. All Rights Reserved. 39
Slide 41: Value Creation through R&D Activities
1. Value Creation through R&D Activities FY2025 FY2026 FY2027 FY2028-FY2030 FY2031-FY2033 Major milestones in the rebuilding of the Launch of next-generation “Value Creation Cycle” will be concentrated pipelines Hematological malignancies, Rare neurological over the next three years & degenerative
Slide 42: Promote Stable Development of the Two Oncology Products
2. Promote Stable Development of the Two Oncology Products • Launch of enzomenib and NDA submission of nuvisertib by FY2027 • We are confidently promoting development of the two oncology compounds for the following three reasons Right target (Drug target relevance) Targets clearly associated with
Slide 43: To Increase the Likelihood of R&D Success
3. To Increase the Likelihood of R&D Success Focus on diseases where the Company can maximize its strengths and promote R&D stepwise with a compact development strategy Key Success Factors Review of the past Current/future actions • Attempted to work on drug targets with • Carefully select more dise
Slide 44: To Maximize the Value of Internal Portfolios
4. To Maximize the Value of Internal Portfolios • Maximize the value of internal portfolios through appropriate means, whether developed internally or through external partnerships • Continually nurture pipelines while reducing the company’s cost burden 1. Partnerships to maximize value utilizing in
Slide 45: Continuous Creation of Innovative New Drugs as an R&D-Driven Company
5. Continuous Creation of Innovative New Drugs as an R&D-Driven Pharmaceutical Company FY2025 FY2026 FY2027 FY2028–2030 FY2031–2033 Launch of next-generation pipelines Hematological malignancies, Rare neurological & Sumitomo Pharma’s R&D capabilities degenerative diseases Bases for CNS drug disc
Slide 46: V. Summary
V. Summary © Sumitomo Pharma Co., Ltd. All Rights Reserved. 45
Slide 47: Reboot for a Strong Sumitomo Pharma: Strategic Scenario for Regrowth
Strategic Scenario for Regrowth Reboot for a “Strong Sumitomo Pharma” Return to self-sustaining growth by rebuilding the Value Creation Cycle based on internal innovation “Strong Sumitomo Pharma” Accelerate through the Value Creation Cycle FY2025 to FY2027 FY2024 Rebuild the Value Creation Cycle Eme
Slide 48: Appendix Contents
＜Contents＞ P.48 Financial Results for FY2024 Financial Results (Full Basis) P.49 Financial Results for FY2024 Financial Position and Cash Flow P.50 Financial Results for FY2024 Segment Information (Core Basis) P.51 Financial Forecasts for FY2025 Revenue of Major Products in Japan P.52 R&D Main Event
Slide 49: Financial Results for FY2024 (Full Basis)
Appendix (Financial Results for FY2024) Financial Results for FY2024 (Full Basis) Billions of JPY FY2023 FY2024 Change Results Results ％ Value Revenue 314.6 398.8 84.3 26.8 Cost of sales 126.6 153.4 26.9 21.2 Gross profit 188.0 245.4 57.4 30.5 SG&A expenses 429.5 180.6 (248.9) (58.0) R&D expenses 11
Slide 50: Financial Position and Cash Flow
Appendix (Financial Results for FY2024) Financial Position and Cash Flow Billions of JPY As of March As of March Ｂ/Ｓ Change 2024 2025 Assets 907.5 742.6 (164.9) Decrease due to amortization and impairment Goodwill / Intangible assets 395.4 369.9 (25.5) Other financial assets (Non-current) 161.7 44.1
Slide 51: Segment Information (Core Basis)
Appendix (Financial Results for FY2024) Segment Information (Core Basis) Billions of JPY North Japan Japan Asia Total America Despite the cost reduction in SG&A expenses, the Revenue 99.8 251.8 47.2 398.8 decline in gross profit from lower sales had a greater Cost of sales 51.8 90.8 10.6 153.2 imp
Slide 52: Revenue of Major Products in Japan
Appendix (Financial Forecasts for FY2025) Revenue of Major Products in Japan Billions of JPY Change FY2024 FY2025 Results Forecasts Value ％ Japan LATUDA® 13.2 13.5 0.3 2.6 Continue to focus on TWYMEEG® sales expansion TWYMEEG® 7.6 11.2 3.6 47.1 METGLUCO® 7.3 7.6 0.3 3.6 Equa®/EquMet® revenue are
Slide 53: Main Events / Targets for FY2024
Appendix (Research and Development) Main Events / Targets for FY2024 (as of May 13, 2025) Revision since the announcement in January 2025 are shown in red Allogeneic iPS cell-derived products (Parkinson’s disease): Submit NDA in Japan Aiming to obtain approval in Japan in FY 2025 Psychiatry Al
Slide 54: Main Events / Targets for FY2025
Appendix (Research and Development) Main Events / Targets for FY2025 (as of May 13, 2025) Allogeneic iPS cell-derived products (Parkinson’s disease): Obtain approval in Japan Allogeneic iPS cell-derived products (Parkinson’s disease): Advance Phase 1/2 study in the U.S. Psychiatry Allogeneic i
Slide 55: Development Pipeline
Appendix (Research and Development) Development Pipeline (as of May 13, 2025) Revisions since the announcement in January 2025 are shown in red Area Generic name/Product code Mechanism of action, etc. Proposed indication Region Development stage Serotonin 5-HT2A receptor antagonist and serotonin 5-
Slide 56: Product Launch Target
Appendix (Research and Development) Psychiatry & Product Launch Target (as of May 13, 2025) Neurology Oncology Others Revisions since the announcement in January 2025 are shown in red FY2025 2026 2027 2028 2029 Allogeneic iPS cell- derived dopaminergic Development neural progenitor cells Parkinson’s
Slide 57: Regenerative Medicine/Cell Therapy Launched Product and Development Pipeline
Appendix (Research and Development) Regenerative Medicine/Cell Therapy Launched Product and Development Pipeline(RACTHERA Co., Ltd.) (as of May 13, 2025) Revision since the announcement in January 2025 are shown in red Brand name/Cell type JP/ Clinical Approval Approval→ Product code Indications Pre
Slide 58: Initiatives for FY2023-2024 (Expansion of Existing Product Business)
Appendix (Reboot 2027) Initiatives for FY2023-2024 (Expansion of Existing Product Business) Strategic alliance with Roivant in FY2019 to strengthen the revenue base after LOE of LATUDA® Successfully developed and launched 4 products and established a growth trend through sales, marketing, and medica
Slide 59: Initiatives for FY2023-2024 (Fundamental Structural Reforms)
Appendix (Reboot 2027) Initiatives for FY2023-2024 (Fundamental Structural Reforms) Implemented fundamental structural reforms across the Group to improve our business performance, refinance and strengthen our financial base Sought to ensure both an early return to financial health and our continued
Slide 60: Initiatives for FY2024 (Asia Joint Venture and Frontier Business Transfer)
Appendix (Reboot 2027) Initiatives for FY2024 (Asia Business Joint Venture Formation＊ and Frontier Business Transfer) It is currently difficult to allocate the strategic investments needed for the Asia and Frontier businesses Given our capital needs, we are driving strategic investments in other gro
Slide 61: Initiatives for FY2024 (Joint Ventures in Regenerative Medicine/Cell Therapy)
Appendix (Reboot 2027) Initiatives for FY2024 (Joint Ventures in Regenerative Medicine/Cell Therapy Business) Strategic alliance with Sumitomo Chemical secures stable funds for investment in the regenerative medicine/cell therapy business. As a leading company in the field of regenerative medicine/c
Slide 62: Our Vision (FY2033 and beyond)
Appendix (Reboot 2027) Our Vision (FY2033 and beyond) To strongly accelerate the Value Creation Cycle, continuously amplify innovation, and implement it in society Through the acceleration of the cycle, strategically deepen and expand strengths, and establish a unique global position Moving through
Slide 63: Individual Businesses (North America)
Appendix (Reboot 2027) Individual Businesses (North America) Aiming for further growth as the core of the Group's business activities and as the revenue base supporting the Group Maximizing the value of existing products Three key products : Maximizing sales and product profitability through the e
Slide 64: Key Products (North America)
Appendix (Reboot 2027) Key Products (North America) Maximize the value of key products, with a focus on ORGOVYX® and GEMTESA® ORGOVYX® Drive demand and brand preference across Urology and Oncology Indications: Advanced prostate cancer Urology: Establish firm position in Androgen Deprivation Therap
Slide 65: Individual Businesses (Japan)
Appendix (Reboot 2027) Individual Businesses (Japan) Contributions to the “rebuilding” of the Company Secure revenues through our strengths and key products, and make regenerative medicine/cell therapy our core business Focus on launching and Maximize the value of key 1 products* and new products 2
Slide 66: Key Products (Japan)
Appendix (Reboot 2027) Key Products (Japan) Maximize the value of key products, with a focus on LATUDA®, TWYMEEG®, and XEPLION®/XEPLION® TRI CNS: To be the best drug for schizophrenia and bipolar I depression LATUDA® Contribute to acute treatment (inpatient and outpatient) by improving positive In
Slide 67: Promote Stable Development of the Two Oncology Compounds
Appendix (Reboot 2027) Promote Stable Development of the Two Oncology Compounds • Dedicate resources to R&D activities to obtain initial approval as a top priority enzomenib (DSP-5336) nuvisertib (TP-3654) Mechanism Mechanism Menin-MLL binding inhibitor PIM1 kinase inhibitor of action of action Targ
Slide 68: iPS-PD Program
Appendix (Reboot 2027) iPS-PD Program (Allogeneic iPS Cell-Derived Dopaminergic Neural Progenitor Cells) • Seek to make this an innovative treatment option to improve motor symptoms in people with Parkinson’s disease • The results of an investigator-initiated clinical trial conducted by Kyoto Univer
Slide 69: Enzomenib (DSP-5336): Menin-MLL Binding Inhibitor
Appendix (Reboot 2027) Enzomenib (DSP-5336): Menin-MLL Binding Inhibitor Seek manufacturing and marketing approval in Japan and the U.S. for relapsed/refractory AML with MLL rearrangement and NPM1 mutation Presented new clinical data from Phase I/II study at American Society of Hematology (ASH) 20
Slide 70: Nuvisertib (TP-3654): PIM1 Kinase Inhibitor
Appendix (Reboot 2027) Nuvisertib (TP-3654): PIM1 Kinase Inhibitor Confirm synergistic effects when used in combination with JAK inhibitor, establish POC in myelofibrosis with high unmet need, and submit for manufacturing and marketing approval in Japan and U.S. Presented new clinical data from Ph
Slide 71: fH1/DSP-0546LP: Universal Influenza Vaccine
Appendix (Reboot 2027) fH1/DSP-0546LP: Universal Influenza Vaccine Leverage our TLR7 adjuvant technology platform to develop next-generation influenza vaccines Promote open innovation that integrates internal/external knowledge and technologies, leveraging public funding Phase I study underway i
Slide 72: DSP-0378: GABAA Receptor Positive Allosteric Modulator
Appendix (Reboot 2027) DSP-0378: γ-Aminobutyric Acid (GABA)A Receptor Positive Allosteric Modulator Seek regulatory approval as soon as possible for a new class of GABAergic treatment with strong efficacy potential for refractory epilepsy A single ascending dose study was completed, confirming fav
Slide 73: Sumitomo Pharma - Innovation today, healthier tomorrows
<& Sumitomo Pharma Innovation today, healthier tomorrows