Boost 2028
Accelerating "Strong Sumitomo Pharma"
March 2, 2026
© Sumitomo Pharma Co., Ltd. All Rights Reserved.
Table of Contents
Part I Review of Reboot 2027
Part II Boost 2028
Sumitomo Pharma's Growth Acceleration
Accelerating Growth Trend
Demonstrating the True Value of R&D
Developing and Establishing Future Growth Engines
PL Management and Financial KPIs
Governance Transformation
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Review of Reboot 2027
Achieved our financial targets ahead of schedule
Expanding sales of 3 key products beyond expectations Delivering record-high profits in the outlook for FY2025
Driving value creation
as an R&D-driven pharmaceutical company
Toward the world's first commercialization of iPS cell-derived products, achieved NDA submission of iPSC-PD (raguneprocel*) in Japan and started the investigator-initiated study in North America
Accelerating in-house clinical development to enable the fastest possible launch of the two oncology compounds
Observing favorable data in safety, tolerability, immunogenicity and cross-reactivity from the interim analysis of a Ph1 study in Europe
* The product name is "AMCHEPRY®". Conditional and time-limited approval was endorsed at the Subcommittee on Regenerative Medicine Products and Biological Technology, Pharmaceutical Affairs Council, Ministry of Health, Labour and Welfare held on February 19, 2026 (prior to official approval by the Minister of Health, Labour and Welfare).
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Achieved Financial Targets Ahead of Schedule
Delivering record-high core operating profits in FY2025 and expecting to achieve the Reboot 2027 financial targets ahead of schedule
Maintaining disciplined SG&A and R&D expenses management to accelerate regrowth following the V-shaped recovery
555.5
Revenue Core operating profit (Billions of JPY)
449.0
398.8
314.6
107.0
43.2
Sales of 3 key products Core operating profit
（Excluding one-time factors*）
Free cash flow
（Excluding divestment-related income）
Interest-bearing debt (End of fiscal year)
Financial Targets under "Reboot" in FY2027
250 billion yen
Consistently more than
25 billion yen Maintain profitability
Reduce to less than
200 billion yen
As early as possible
FY2025
Forecasts
Approx. 260 billion yen Approx. 43 billion yen Approx. 47 billion yen
Approx. 220 billion yen
(Net Debt Approx. 190 billion yen)
16.4
* Includes sales milestone income and profit from the divestment of the Asian business
Cost Management Performance (FY2025 forecast vs FY2022)
(133.0)
FY2022 FY2023 FY2024 FY2025
Forecasts
SG&A Expense
FY2022
305.6 B yen
FY2025
Approx. 156 B yen
R&D Expense
FY2022
106.1 B yen
FY2025
Approx. 43 B yen
Number of Employees （Consolidated）
End of FY2022
6,250
End of Sep. 2025
3,098
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FY2025 Performance
Driving substantial sales growth of ORGOVYX® and GEMTESA® in the North America
Strengthening our earnings base in Japan through promotional partnerships that leverage our business platform Restructured the Asian business to sharpen focus on core business areas
Growth of the 3 Key Products Promotional Partnership
Y2024
%
Compared to F
+64
ORGOVYX®
Revenue reached $1.0B Receipt of a sales milestone Up +88% YoY
Ozempic® Subcutaneous Injection
Treatment for type 2 diabetes
Wegovy® Subcutaneous Injection
Treatment for obesity disease
21年度 22年度 23年度 24年度 25年度
（予想）
FY21
FY22
FY23
FY24
FY25
Forecast
GEMTESA®
Revenue reached $600M Up +45% YoY
MYFEMBREE®
Restructuring of the Asia Business
Completed the initial transaction of share transfer (Continuing product supply to Asia)
Earnings from the Asia business transfer
49.0 billion yen
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"True Value" of R&D Demonstrated in FY2025 and the Next Step
Universal Influenza Vaccine |
【Europe】 Observed favorable tolerability, a statistically significant increase in antibody titers, and cross-reactivity in the Ph1 interim analysis (Feb. 2026) |
Evaluating protective efficacy in a controlled human infection model (CHIM) study*1 |
Allogeneic iPS Cell-derived Dopaminergic Neural Progenitor Cells (raguneprocel) |
【Japan】 NDA submission based on the data from the investigator-initiated study by Kyoto Univ. (Aug. 2025) 【North America】 Completed the first clinical administration in an investigator-initiated study (Jun. 2025) |
Advancing commercialization as one team across the Sumitomo Chemical Group Steadily executing clinical studies and regulatory activities in Japan and North America |
Two Oncology Compounds
Accelerating clinical studies with a focus on achieving earliest market launch
Assessing options either strategic alliances or self-led development to maximize value at the VIP*3
【Enzomenib】
Initiated the pivotal study*2 (Assessment phase of Ph2 study) (Q1 FY2025)
【Nuvisertib】
Received Fast Track designation in the U.S. (Jun. 2025)
*1：A study that deliberately exposes healthy adults to influenza virus to rapidly assess vaccine protective efficacy
*2：A key clinical study conducted to support regulatory approval
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*3：Value Inflection Point: a critical milestone that materially increases the value of an asset in development 6
Development Pipeline (As of the end of Feb. 2026)
FY2025 Progress highlighted in red boxes and text
Completed the first clinical administration in investigator-initiated clinical study
（Jun. 2025）
Psychiatry & Neurology
Area
Phase-1
DSP-0187
（Narcolepsy）
DSP-0378
（Progressive Myoclonic Epilepsy; Developmental Epileptic Encephalopathy）
DSP-0038
（Alzheimer's disease psychosis）
DSP-3456
（Treatment resistant depression）
DSP-2342
（To be determined）
Nuvisertib
（Myelofibrosis）
DSP-0390
（Glioblastoma）
SMP-3124
（Solid tumors）
Phase-2
CT1-DAP001/DSP-1083
（Parkinson's disease/Investigator-initiated study, Company-sponsored clinical study）
HLCR001
（Retinal pigment epithelium tear）
DSP-3077
（Retinitis pigmentosa）
Enzomenib
（Acute leukemia）
Received Fast Track designation in the U.S. (Jun. 2025)
Phase-3
Approval Application
CT1-DAP001/DSP-1083
（Parkinson's disease/Investigator-initiated study）
NDA submission （Aug. 2025）
Initiated a pivotal study (Q1 FY2025)
Oncology
KSP-1007
Others
（Complicated urinary tract and intraabdominal infections, Hospital-acquired bacterial pneumonia）
fH1/DSP-0546LP
（Influenza virus prophylaxis）
Confirmed tolerability/safety, increased antibody titers, and cross-reactivity （Feb. 2026）
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Boost 2028
Sumitomo Pharma's Growth Acceleration
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Sumitomo Pharma's Growth Story: from "Reboot" to "Boost"
Transition from Structural Reforms aimed at rebuilding the Value Creation Cycle to a Full-Fledged Growth Strategy
Rebuilding the Value Creation Cycle
Reboot
Financial discipline and operating policy as an R&D-driven pharmaceutical company
Transitioning from "Value Creation" to "Value Delivery"
>Boost
Strengthening the foundation for regrowth while maintaining financial discipline
Pursuing progress guided by the fundamental R&D strategy
Full-Fledged Growth Strategy
Driving sustainable growth strategy as an R&D-driven pharmaceutical company
Expanding our attractive pipeline and portfolio
Executing structural reforms
Expanding
the 3 key products
Further sales expansion
Developing next-generation growth engines
Determination of the strategy for the two oncology compounds
Creating the new Mid-Term Business Plan after defining the strategic direction for the two oncology compounds
Strengthening our financial base
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 9
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 and bring to market innovative drugs
Competitive drug discovery research focused on our strong areas and technologies
Early confirmation of value in small clinical trials
Maximize value quickly by leveraging alliances
Deepen and expand R&D infrastructure
and
now-
Superior access to information, technology, seeds of drug discovery, human resources
Feedback of proprietary data and k how
Value Creation Cycle
Maximize market value and improved patient outcomes
Deliver to the world, focusing on the U.S. and Japan
Establish scientific evidence and become a leader in innovative/groundbreaking drug discovery
Continued growth of portfolio brands and expand management resources
High market share/profit margins
Accumulate unique data and expertise
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Boost of "Strong Sumitomo Pharma"
Accelerating Growth Realizing Value Driving Innovation
With Financial Discipline
Accelerating Growth
Reach "patients who can be saved" with this medicine
- Expand outreach to new patient segments to enhance healthcare impact and accelerate market share growth
Promotion based on "scientific evidence"
- Communicate economic benefits in addition to product value (safety and efficacy)
Realizing Value
Deliver "swiftly"
- Accelerate development to deliver the most appropriate treatments to patients with acute leukemia and myelofibrosis as early as possible
Deliver "broadly"
- Advance indication expansion through the optimal approach to reach as many patients as possible
Driving Innovation
Create value "successively"
- Leverage our technologies and expertise to build a continuously advancing, sustainable portfolio
Catalyze a "paradigm shift" in healthcare
- Provide new treatment options through regenerative medicine/cell therapy
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Accelerating Growth Trend
Emphasizing the intrinsic values of products
Reach "patients who can be saved" with this medicine
- Expand outreach to new patient segments to enhance healthcare impact and accelerate market share growth
Promotion based on "scientific evidence"
- Communicate economic benefits in addition to product value (safety and efficacy)
Accelerating Growth© Sumitomo Pharma Co., Ltd. All Rights Reserved. 12
ORGOVYX®
While expanding revenue rapidly following healthcare system reform in the U.S., retaining significant potential for further market share growth
Aiming to reach revenue of approx. 250 billion yen in the 2030s through proactive promotional activities
A dual approach that engages both patients
Potential for share expansion in ADT*1 market
ADT market
Annual Revenue Target*2
250 billion yen in 2030s
As of
Oct. 2025
14 %*3
Expand Market Share
and healthcare professionals
Actively promote to improve
awareness of the significant reduction in patient out-of-pocket costs under the Inflati Reduction Act*4
Patients
Expand awareness of the product's differentiation as the only oral option in hormone therapy
Healthcare professionals
on
The revised FY2025 forecast is expected at approx. 150 billion yen
(Converted at the rate of 150 yen per USD)
*1: Androgen Deprivation Therapy *2: Net product revenue basis
*3: Internal calculation based on information licensed from IQVIA: NSP Volume for the period 10/1 to 10/31, 2025 reflecting estimates of real-world activity. All rights reserved.
*4: Under Medicare Part D, the annual out-of-pocket cap has been set at $2,000 in CY2025, with no out-of-pocket costs above the cap
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GEMTESA®
Expecting continued expansion of the β3 agonist market, driven in part by the entry of generics for the competing product
Aiming to achieve revenue of approx. 150 billion yen in the 2030s through promotional investments that highlight clinical usefulness
Potential for share expansion of the
β3 agonist market
Switching from anticholinergic drugs
Gaining Market share in the OAB*1 market
Annual Revenue Target*2
150 billion yen in 2030s
As of
Oct. 2025 Expa
Expand Market Share
nsion in
Establish GEMTESA® as the standard of care
efits and key differentiation
ithout a blood-pressure warni
Emphasizing clinical ben
β3 agonist
A more user-friendly option than anticholinergic drugs
GEMTESA
The only β3 agonist w ng
The only β3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for benign prostatic hyperplasia, offering
11 %*3
the β3 agonist market
benefits for male patients
The revised FY2025 forecast is expected at approx. 90 billion yen
(Converted at the rate of 150 yen per USD)
*1: Overactive bladder *2: Net product revenue basis
*3: This is based on information licensed from IQVIA: NPA for the period 10/1 to 10/31, 2025 reflecting estimates of real-world activity. All rights reserved.
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Demonstrating the True Value of R&D
Deliver "swiftly"
Accelerate development to deliver the most appropriate treatments to patients with acute leukemia and myelofibrosis as early as possible
Deliver "broadly"
Advance indication expansion through the optimal approach to reach as many patients as possible
Realizing Value© Sumitomo Pharma Co., Ltd. All Rights Reserved. 15
A New Revenue Stage Unlocked by the Two Oncology Compounds
Next-generation revenue drivers following ORGOVYX® and GEMTESA®
A touchstone for the revival of an R&D-driven pharmaceutical company through in-house innovation*
CNS
* Received multiple regulatory designations to accelerate development from regulatory authorities in Japan, the U.S., and Europe, based on favorable drug profiles and early-phase clinical study results
Enzomenib： Fast Track (the U.S.), Orphan drug (Japan and the U.S.) Nuvisertib ： Fast Track (the U.S.), Orphan drug (Japan, the U.S. and Europe)
Enzomenib
Target launch
Nuvisertib
Target launch
Illustrative image of revenue contribution from newly launched products
2025年
2030年頃
2035年頃
2025 Around 2030 Around 2035
Deliver "swiftly" Deliver "broadly"
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Business Potential of the Two Oncology Compounds
Enzomenib
Nuvisertib
Target Indication
Mechanism of action
Expected competitive advantages
Aimed positioning
Development Phases
Acute leukemia
(KMT2A-rearranged or NPM 1-mutated)
Selective menin inhibition
Promising efficacy and a favorable safety profile
(potentially lower risk of cardiac adverse events and differentiation syndrome)
Best-in-class therapy in the menin inhibitor market
(No limitations on concomitant use with azole antifungals)
Phase 1/2
Monotherapy for relapsed/refractory acute leukemia
Combination therapy with venetoclax/azacitidine for newly diagnosed
Myelofibrosis
PIM1 kinase inhibition
(novel mechanism of action)
Promising efficacy and a favorable safety profile
(potential to improve bone marrow fibrosis)
First-in-class therapy for first-line use in combination with the standard of care
(No limitations on use in patients with low platelet counts)
Phase 1/2
Monotherapy for relapsed/refractory myelofibrosis Combination therapy with momelotinib for newly diagnosed or relapsed/refractory
Target launch date
FY2027
FY2028
Peak sales forecast
Over 100 billion yen
Expect over 200 billion yen with indication expansions
Over 100 billion yen
Indication expansions under consideration
Acute myeloid leukemia incidence rate*1 (U.S.: 21,000/ year; Japan: 8,000/ year) Acute myeloid leukemia drug market size*1 (2024: US$1.67B; 2030: US$2.49B)
*1 Global Data
Number of myelofibrosis patients*1 (U.S.: 13,000; Japan: 2,000) Myelofibrosis drug market size*1 (2024: US$1.55B; 2030: US$1.54B)
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Development Strategy for the Two Oncology Compounds
Based on the clinical potential of the two oncology compounds, focusing resources on these programs as top-priorities and pursuing the fastest possible market launch
Determining the optimal development strategy at the next VIP* for maximizing value through indication expansions
The fastest and
successful market launch
Maximizing the value
Right
Target
Select and validate drug targets by leveraging the cutting-edge science and the collaboration with academia
Right
Plan
Assess the proof-of-concept (efficacy and safety) in the early stages of clinical development by using objective indicators
Clarify the pathway to regulatory approval through constructive discussions with regulatory authorities
At the next VIP, determine the development strategy to secure resources for indication expansions and effectively manage R&D expenses, having partnering as a primary option
Identifying partners capable of appropriately evaluating the two compounds and contributing to maximizing their value
Right
Action
Expand clinical study sites to Europe and Asia in addition to Japan and the U.S., and drive global clinical studies forward in the highly competitive field of oncology
* Assumed next VIPs Enzomenib ：Ph2 topline results in relapsed/refractory acute leukemia with KMT2A rearrangement
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Nuvisertib ：Successful Health Authority meetings on the Ph3 study design, based on results from the Ph1/2 momelotinib combination study in myelofibrosis 18
Developing and Establishing Future Growth Engines
Create value "successively"
Leverage our technologies and expertise to build a continuously advancing, sustainable portfolio
Catalyze a "paradigm shift" in healthcare
Provide new treatment options through regenerative medicine/cell therapy
Driving Innovation© Sumitomo Pharma Co., Ltd. All Rights Reserved. 19
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