Conference on FY2025
(April 1, 2025 to March 31, 2026)
Financial ResultsToru Kimura, President and CEO Sumitomo Pharma Co., Ltd.
May 13, 2026
Financial Results for FY2025
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 2
Financial Results for FY2025
Financial Results for FY2025 (Core Basis)Revenue increased primarily due to the growth of ORGOVYX® and GEMTESA® and sales milestone revenue from ORGOVYX®
SG&A expenses and R&D expenses decreased due to business structure improvements, partial transfer of the Asian business, and realignment of the regenerative medicine and cell therapy business
Others (core basis)
FY2024: Gain on transfer of the regenerative medicine and cell therapy business
FY2025: Gain on partial transfer of the Asian business +¥49.0B
Adjustment items:
FY2024: Business structure improvement expenses in Japan and North America
FY2024 Results | FY2025 Results | Change | |||
Value | FX impact | % | |||
Revenue | 398.8 | 453.3 | 54.5 | (5.3) | 13.7 |
Cost of sales | 153.2 | 196.4 | 43.2 | (0.9) | 28.2 |
Gross profit | 245.6 | 256.9 | 11.2 | (4.4) | 4.6 |
SG&A expenses | 167.7 | 159.3 | (8.4) | (1.4) | (5.0) |
R&D expenses | 48.5 | 43.9 | (4.5) | (0.4) | (9.4) |
Others (core basis) | 13.7 | 52.3 | 38.6 | ||
Core operating profit | 43.2 | 105.9 | 62.8 | (2.6) | 145.4 |
Adjustment items (negative number indicates net expense) | (14.3) | 1.4 | 15.8 | ||
Operating profit | 28.8 | 107.3 | 78.5 | 272.6 | |
Finance income/costs | (11.2) | (7.0) | 4.2 | ||
Profit before taxes | 17.6 | 100.3 | 82.7 | 469.8 | |
Income tax expenses | (6.0) | (6.5) | (0.5) | ||
Net profit attributable to owners of the parent | 23.6 | 106.9 | 83.2 | 352.2 | |
Billions of JPY
FY2025
Mar. 2 forecasts
449.0
107.0
108.0
102.0
Average rates:
FY2024 Results : 1US$ = ¥152.62, 1RMB = ¥21.11 FY2025 Results : 1US$ = ¥150.67, 1RMB = ¥20.12 FY2025 forecasts : 1US$ = ¥150.00, 1RMB = ¥20.12
Period end rates:
As of the end of March 2025 : 1US$ = ¥149.53, 1RMB = ¥20.59 As of the end of March 2026 : 1US$ = ¥159.90, 1RMB = ¥20.74
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 3
Financial Results for FY2025
Revenue of Major Products in North AmericaFY2024 Results | FY2025 Results | Change | FY2024 Results | FY2025 Results | Change | |||
Value | FX impact | % | ||||||
North America | Millions of USD | Billions of JPY | ||||||
ORGOVYX® | 544 | 1,029 | 484 | 83.1 | 155.0 | 71.9 | (2.0) | 86.6 |
MYFEMBREE® | 84 | 96 | 12 | 12.8 | 14.4 | 1.6 | (0.2) | 12.6 |
GEMTESA® | 431 | 637 | 206 | 65.8 | 96.0 | 30.2 | (1.2) | 46.0 |
RETHYMIC® | 45 | 42 | (3) | 6.8 | 6.3 | (0.5) | (0.0) | (7.1) |
APTIOM® | 258 | 99 | (159) | 39.4 | 14.9 | (24.5) | (0.2) | (62.1) |
Others | 80 | 56 | (24) | 12.2 | 8.0 | (4.2) | (0.1) | (34.3) |
Export products/ One-time revenue, etc.* | 208 | 287 | 78 | 31.8 | 43.3 | 11.5 | (0.7) | 36.1 |
Total | 1,650 | 2,245 | 595 | 251.8 | 337.9 | 86.1 | (4.5) | 34.2 |
ORGOVYX® and GEMTESA® revenue increased significantly year-on-year
APTIOM® revenue decreased due to loss of exclusivity
Sales milestone revenue from ORGOVYX® has been recognized
* Major items included in Export products/One-time revenue, etc. | |||||
Deferred revenue from | |||||
FY2024 Results | Deferred revenue from the collaboration with Pfizer | $171M | FY2025 Results | the collaboration with Pfizer Sales milestone revenue from ORGOVYX® | $88M $100M |
(sales exceeding $500M) | |||||
Average rates:
FY2024 Results : 1US$ = ¥152.62 FY2025 Results : 1US$ = ¥150.67
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 4
Financial Results for FY2025
Revenue of Major Products in JapanBillions of JPY
FY2024 Results | FY2025 Results | Change | ||
Value | ％ | |||
Japan | ||||
LATUDA® | 13.2 | 13.7 | 0.5 | 4.1 |
TWYMEEG® | 7.6 | 10.6 | 3.0 | 39.0 |
METGLUCO® | 7.3 | 7.4 | 0.1 | 1.3 |
Equa®/EquMet® | 24.9 | 8.7 | (16.2) | (64.9) |
LONASEN® Tape | 4.6 | 5.0 | 0.4 | 8.2 |
XEPLION®/XEPLION TRI® | - | 3.2 | 3.2 | - |
AG products | 11.4 | 12.1 | 0.7 | 5.9 |
Others | 22.9 | 22.6 | (0.3) | (1.4) |
Export products/ One-time revenue, etc. | 7.9 | 9.0 | 1.1 | 14.4 |
Total | 99.8 | 92.4 | (7.5) | (7.5) |
TWYMEEG® revenue continued to grow
Equa®/EquMet® revenue decreased due to loss of exclusivity (discontinued in Dec. 2025)
XEPLION®/XEPLION TRI® transitioned to in-house distribution in January
Note: Sales of each product are shown by invoice price
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 5
Financial Forecasts for FY2026
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 6
Financial Forecasts for FY2026
Boost Toward "Strong Sumitomo Pharma"Achieved a V-shaped recovery through fundamental structural reforms. By further revenue growth of ORGOVYX® and GEMTESA® and the development of next-generation growth engines, we are now entering a phase of Boost toward "Strong Sumitomo Pharma."
Delay in adjusting scale and deterioration of PL
Rebuilding the Value Creation Cycle
Reboot 2027
From "Value Creation" to "Value Delivery"
Boost 2028
1
Further revenue expansion of ORGOVYX® and GEMTESA®
1
Implementation of fundamental structural reforms
Overestimation of the potential of acquired products
Streamlining, selection and concentration
Development failure of new drug candidates
Revision of R&D investment strategy
LOE of LATUDA®
2
Expansion of revenues for the 3 key products*
Fastest possible market launch of the two oncology compounds
2
3
Developing next-generation growth engines
4 Strengthening our financial base
* ORGOVYX®, GEMTESA® and MYFEMBREE®
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 7
Financial Forecasts for FY2026
Allocation to Investment in Medium- to Long-Term Growth, Balanced with Financial Discipline and Based on Sound Financial FoundationsSound Financial Foundation
Financial Restructuring
Financial constraints Debt guarantees Subordinated debt
Debt
Before Financial Restructuring
(Equity Financing and Refinancing) After Financial Restructuring
Borrowings without debt guarantees
Increased borrowing capacity for investment in growth
Decision to release debt guarantees through refinancing
Improved equity ratio
Defined pathway toward replacement of subordinated debt
Low equity ratio
Equity
Achieved record-high earnings Executed a public equity offering
R&D Investment
FY2026 forecast: JPY 51 billion
Key initiatives
Fastest possible launch and value expansion of two oncology assets
Development of next-generation revenue bases (CNS and infectious diseases)
Capital Expenditure / Investments and Loans
FY2026 forecast: JPY 12 billion
Key initiatives
Strengthening of existing businesses (production capabilities, quality management systems, etc.)
Investments and loans to RACTHERA and S-RACMO
Shareholder Returns
FY2026 outlook: undetermined Decision based on future business performance
Key decision factors
Cash flow
Financial condition, including equity ratio
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8
Financial Forecasts for FY2026
Change in Reportable Segments (from FY2026)Previously, operating segments were disclosed by region based on the entity recording sales. Reflecting our globally integrated operations, we have adopted a single Pharmaceuticals segment.
(Former reportable segments)
Regional segments (Japan/North America/Asia)
(New reportable segment)
Single Pharmaceuticals segment
Regional information will continue to be disclosed based on the markets rather than the entity recording sales.
Until FY2025 | ||
Segment | Consolidated selling entity | Market |
Japan | Sumitomo Pharma Sumitomo Pharma Promo | Japan |
Ex-Japan | ||
North America | SMPA（Sumitomo Pharma America, Inc.） SMPS（Sumitomo Pharma Switzerland GmbH） | U.S. |
Ex-U.S. | ||
Asia | Asian subsidiaries (until July, 2025) Product Supply to Marubeni Global Pharma (from August, 2025) | Asia |
From FY2026 | |
Segment | Market |
Pharma ceuticals | Japan |
U.S. | |
Other | |
The change in segmentation has no impact on consolidated financial results.
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 9
Financial Forecasts for FY2026
Financial Forecasts for FY2026 (Core Basis)Billions of JPY
FY2025 Results | FY2026 Forecasts | Change | |||
Value | FX impact | % | |||
Revenue | 453.3 | 540.0 | 86.7 | 12.2 | 19.1 |
Cost of sales | 196.4 | 245.0 | 48.6 | 3.5 | 24.7 |
Gross profit | 256.9 | 295.0 | 38.1 | 8.7 | 14.8 |
SG&A expenses | 159.3 | 155.0 | (4.3) | 3.4 | (2.7) |
R&D expenses | 43.9 | 51.0 | 7.1 | 0.9 | 16.0 |
Others (core basis) | 52.3 | 2.0 | (50.3) | (96.2) | |
Core operating profit | 105.9 | 91.0 | (14.9) | 4.4 | (14.1) |
Adjustments (negative number indicates loss) | 1.4 | (1.0) | (2.4) | ||
Operating profit | 107.3 | 90.0 | (17.3) | (16.2) | |
Finance income/costs | (7.0) | (6.5) | 0.5 | ||
Income tax expenses | (6.5) | 6.5 | 13.0 | ||
Net profit attributable to owners of the parent | 106.9 | 77.0 | (29.9) | (27.9) | |
R O E * | 46.3% | 20.3% | |||
R O I C * | 22.8% | 15.1% | |||
Revenue:
U.S. + ¥84.6B :
Continued growth of ORGOVYX® and GEMTESA®, incorporating ORGOVYX® sales milestone revenue
Cost of sales:
Incorporates a certain level of risk related to tariffs and inflation
SG&A expenses:
Decrease, despite unfavorable FX impacts
R&D expenses:
Accelerating development of oncology products and advancing CNS programs
Others (core basis):
Gain from the partial transfer of Asian business in the prior year
* FY2026 forecasts reflect the completed public offering and planned debt repayment.
Average rates:
FY2025 Results : 1US$ = ¥150.67, 1RMB = ¥20.12
FY2026 Forecasts : 1US$ = ¥155.00
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 10
Financial Forecasts for FY2026
Core Operating Profit Bridge FY25 vs FY26Billions of JPY
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Financial Forecasts for FY2026
Revenue of Major Products in U.S.FY2025 Results | FY2026 Forecasts | Change | FY2025 Results | FY2026 Forecasts | Change | |||
Value | FX impact | % | ||||||
U.S. | Millions of USD | Billions of JPY | ||||||
ORGOVYX® | 1,029 | 1,354 | 325 | 155.0 | 209.9 | 54.9 | 5.9 | 35.4 |
MYFEMBREE® | 96 | 100 | 4 | 14.4 | 15.4 | 1.0 | 0.4 | 7.3 |
GEMTESA® | 637 | 686 | 49 | 96.0 | 106.3 | 10.3 | 3.0 | 10.7 |
RETHYMIC® | 42 | 35 | (7) | 6.3 | 5.4 | (0.9) | 0.1 | (14.2) |
APTIOM® | 99 | 35 | (64) | 14.9 | 5.4 | (9.5) | 0.2 | (63.6) |
Others* | 234 | 412 | 178 | 35.2 | 63.9 | 28.7 | 2.2 | 81.7 |
Total | 2,137 | 2,622 | 485 | 321.8 | 406.4 | 84.6 | 11.8 | 26.3 |
ORGOVYX® and GEMTESA® revenue are expected to increase significantly
APTIOM® revenue is expected to decline due to the impact of generic products
Sales milestone for ORGOVYX® is expected in FY2026
* Major items included in Others | |||||
Deferred revenue from | Deferred revenue from | ||||
FY2025 Results | the collaboration with Pfizer Sales milestone revenue from ORGOVYX® | $88M $100M | FY2026 Forecasts | the collaboration with Pfizer Sales milestone revenue from ORGOVYX® | $65M $325M |
(sales exceeding $500M) | (sales exceeding $1.0B) | ||||
FX rates:
FY2025 Results : 1US$ = ¥150.67 FY2026 Forecasts : 1US$ = ¥155.00
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 12
Accelerate adoption in oncology where opportunity exists by
strengthening promotion, enhancing engagement with key medical congresses, peer-to-peer initiatives, and DTC*3 advertising
Capitalize on improvements in access and patient affordability through
raising awareness of patient out-of-pocket costs among HCPs, payers, and patients
Note: Forecast represents product sales only and does not include sales milestone
2026
(Forecast)
2025
2024
2023
2022
2021
FY
FY2026 Forecast ($M)
83
181
292
Maximize growth in key segments, such as urology and radiation
oncology, by emphasizing clinical benefits, enhancing engagement with key medical congresses, and executing strategic initiatives for scale up through GPOs*2
544
1,029
1,354
Financial Forecasts for FY2026
ORGOVYX®FY2025 Performance
FY2025 Initial Forecast | FY2025 Results | Year-over-year comparison |
$710M | $1,029M (Achievement: 145%) | Approx. 89％ Increase |
Volume: Nearly doubled compared to last year and significantly outperformed the initial forecast by $260M, driven by changes in the Medicare Part D patient Out of Pocket Costs. NPS*1 in March reached a record high
Price: Outperformed the initial forecast by $32M due to favorable payer mix and lower usage of coupon
Note: Achieved revised forecast ($1,020M)
Commercial Strategy
Further expand market share through continued growth in urology and enhanced engagement with oncologists
*1: New Patient Start *2: Group Purchasing Organizations *3: Direct to Consumer
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 13
(Forecast)
Elevate OAB*1 treatment expectations by amplifying GEMTESA®
strong efficacy and safety profile via online education to HCPs and direct to patient initiatives, leveraging patient ambassadors' program
Solidify conviction for GEMTESA® clinical differentiation
with an elevated promotional focus on patients with hypertension and men with OAB and BPH*2
Strengthen the perception of the access of GEMTESA® through strong and broad promotion of updated coverage status
2026
2025
2024
2023
2022
2021
FY
63
182
255
431
637
686
FY2026 Forecast ($M)
Financial Forecasts for FY2026
GEMTESA®FY2025 Performance
FY2025 Initial Forecast | FY2025 Results | Year-over-year comparison |
$572M | $637M (Achievement: 111%) | Approx. 48％ Increase |
Volume: Exceeded the initial forecast by $27M due to the steady growth of demand and share in expanding β3 market by clinical differentiation
Price: Outperformed the initial forecast by $40M due to favorable payer mix
Note: Overachieved revised forecast ($588M)
Commercial Strategy
Continue to focus on growing GEMTESA® market share through emphasis on GEMTESA® clinical differentiation and improved coverage in Medicare part D
*1: Overactive bladder *2: Benign Prostatic Hyperplasia
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 14
Financial Forecasts for FY2026
GEMTESA®FY2025
As a result of strategic negotiations with payers, coverage in major insurance plans declined, and pricing (GTN*¹) temporarily improved
During this period, demand remained solid, leading to the resumption of coverage by some insurance plans
FY2026
Pricing (GTN) is expected to decline due to factors such as the full-year impact of coverage resumption and Inflation Reduction Act (IRA) *²
Meanwhile, demand is growing strongly, supported by improved patient access, and progress is being made toward achieving sales of JPY 150 billion in the 2030s.
Variance Analysis: Previous Years vs FY2026 Forecast ($M) Number of Prescription by Fiscal Years*3
+30% over
(144)
+25%
FY FY
2021 2022 2023
2024
2025
2026 (Forecast)
2024年度
2021年度
2022年度
2023年度
年度 2026 年度
2025
*1. GTN (Gross-to-Net): An adjustment rate calculated by subtracting rebates, discounts, deductions, etc., from gross sales.
*2. The Inflation Reduction Act (IRA) lowered the out-of-pocket patient payment limit for Medicare Part D and also changed the phases and percentages of the burden borne by pharmaceutical companies. Small manufacturers are given a gradual grace period for the application of these changes.
*3: Information licensed from IQVIA (NPA for the period April 1, 2021 to March 31, 2026, reflecting estimates of real-world activity). All rights reserved.
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 15
Financial Forecasts for FY2026
Gross Profit by Region (Core Basis)Japan
XEPLION®/XEPLION TRI® contribute to increasing revenue, but gross profit decreases due to the product mix.
U.S.
Gross profit increases due to increased revenue.
Other
Profit decreases due to the partial transfer of the Asian business.
Japan | U.S. | Other | Total | ||
FY2026 Forecast | Revenue | 87.6 | 406.4 | 46.0 | 540.0 |
Cost of sales | 52.1 | 152.7 | 40.2 | 245.0 | |
Gross profit | 35.5 | 253.7 | 5.8 | 295.0 | |
FY2025 Results | Revenue | 83.4 | 321.8 | 48.1 | 453.3 |
Cost of sales | 43.7 | 123.2 | 29.5 | 196.4 | |
Gross profit | 39.6 | 198.7 | 18.6 | 256.9 |
Billions of JPY
Change | Revenue | 4.2 | 84.6 | (2.1) | 86.7 |
Cost of sales | 8.4 | 29.5 | 10.7 | 48.6 | |
Gross profit | (4.1) | 55.0 | (12.8) | 38.1 |
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Research and Development
© Sumitomo Pharma Co., Ltd. All Rights Reserved. 17
Research and Development
Development Pipeline (As of May 13, 2026)Revisions since the announcement in January 2026 are shown in red
© Sumitomo Pharma Co., Ltd. All Rights Reserved.
Area | Generic Name/Product Code | Mechanism of Action, etc. | Planned Indication(s) | Development Stage |
Psychiatry & Neurology | DSP-0038 | Serotonin 5-HT2A receptor antagonist and serotonin 5-HT1A receptor agonist | Alzheimer's disease psychosis | Phase 1 |
DSP-0187 | Selective orexin-2 receptor agonist | Narcolepsy | Phase 1 | |
DSP-3456 | Metabotropic glutamate receptor 2/3 negative allosteric modulator (mGluR2/3 NAM) | Treatment resistant depression | Phase 1 | |
DSP-0378 | Gamma-aminobutyric acid (GABA) A receptor positive allosteric modulator | Progressive Myoclonic Epilepsy Developmental Epileptic Encephalopathy | Phase 1 | |
DSP-2342 | Serotonin 5-HT2A and 5-HT7 receptor antagonist | To be determined | Phase 1 | |
DSP-0551 | Multi-ion channel modulator | Tremor associated with Parkinson's disease | Phase 1 | |
CT1-DAP001/DSP-1083 (Japan) | Allogeneic iPS [induced pluripotent stem] cell-derived dopaminergic neural progenitor cells | Parkinson's disease | Conditional and time-limited approval obtained (Mar 2026) ⇒ Post-marketing clinical study in preparation | |
CT1-DAP001/DSP-1083 (U.S.) | Allogeneic iPS cell-derived dopaminergic neural progenitor cells | Parkinson's disease/Investigator-initiated study, Company- sponsored clinical study | Phase 1/2 | |
HLCR011(Japan) | Allogeneic iPS cell-derived retinal pigment epithelial cells | Retinal pigment epithelium tear | Phase 1/2 | |
DSP-3077(U.S.) | Allogeneic iPS cell-derived retinal sheet | Retinitis pigmentosa | Phase 1/2 | |
Oncology | Enzomenib | Selective menin inhibitor | Acute leukemia | Phase 2 |
Nuvisertib | PIM1 kinase inhibitor | Myelofibrosis | Phase 1/2 | |
SMP-3124 | CHK1 inhibitor | Solid tumors | Phase 1/2 | |
DSP-0390 | EBP inhibitor | Glioblastoma | Phase 1 | |
Others | KSP-1007 | β-lactamase inhibitor | Complicated urinary tract and intraabdominal infections, Hospital-acquired bacterial pneumonia | Phase 1 |
fH1/DSP-0546LP | Split, Adjuvanted vaccine | Influenza virus prophylaxis | Phase 1 |
18
Research and Development
Major Topics in Clinical Development (January 31- May 13, 2026)Psychiatry & Neurology
Allogeneic iPS cell-derived dopaminergic neural progenitor cells (U.S., Japan) (collaboration with RACTHERA)
・Parkinson's disease
In March 2026, obtained conditional and time-limited approval in Japan (product name: AMCHEPRY®)
The proposed NHI reimbursement price is scheduled to be discussed at the Central Social Insurance Medical Council meeting on May 13
Post-marketing clinical study to be initiated in 2026 (see page 21 for details)
Allogeneic iPS cell-derived retinal sheet (DSP-3077) (U.S.) (collaboration with RACTHERA)
・Retinitis pigmentosa
In March 2026, granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for retinitis pigmentosa
Lurasidone (Japan)
・Schizophrenia (product name: LATUDA®)
In Japan, submitted a partial change application to add pediatric dosage and administration for the treatment of schizophrenia
DSP-0551 (Japan)
・Tremor associated with Parkinson's disease Initiation of a Phase 1 study (see page 22 for details)
DSP-0378 (Japan)
Progressive myoclonic epilepsy / Developmental epileptic encephalopathy
Initiation of Phase 1 studies (multiple-dose and drug-drug interaction studies), and initiation of dosing in the Phase 1b study
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