Sumitomo Pharma (4506): FY2025 Results Summary — Record-High Earnings on ORGOVYX and GEMTESA Growth

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Sumitomo Pharma Co., Ltd. (TSE: 4506) reported results for FY2025 (April 1, 2025 to March 31, 2026) at its financial results conference on May 13, 2026. Revenue rose 13.7% year on year to 453.3 billion yen, core operating profit increased 145.4% to 105.9 billion yen, and net profit attributable to owners of the parent grew 352.2% to 106.9 billion yen. Revenue growth was driven primarily by ORGOVYX and GEMTESA in North America, including sales milestone revenue from ORGOVYX, while other income on a core basis included a 49.0 billion yen gain on the partial transfer of the Asian business. The company states that it achieved record-high earnings and, having completed a V-shaped recovery through fundamental structural reforms, is entering a phase of “Boost toward Strong Sumitomo Pharma.”

Consolidated Results (Full-Year Actual)

On a core basis, gross profit increased 4.6% to 256.9 billion yen. SG&A expenses fell 5.0% to 159.3 billion yen and R&D expenses fell 9.4% to 43.9 billion yen, reflecting business structure improvements, the partial transfer of the Asian business, and the realignment of the regenerative medicine and cell therapy business. Against the forecasts announced on March 2, revenue of 453.3 billion yen exceeded the 449.0 billion yen forecast and net profit of 106.9 billion yen exceeded the 102.0 billion yen forecast, while core operating profit of 105.9 billion yen came in against a forecast of 107.0 billion yen. Adjustment items turned positive at 1.4 billion yen (FY2024: negative 14.3 billion yen, mainly business structure improvement expenses in Japan and North America), lifting operating profit 272.6% to 107.3 billion yen.

Item (Core Basis, Billions of JPY)	FY2025	FY2024	Change	Change (%)
Revenue	453.3	398.8	54.5	13.7
Gross profit	256.9	245.6	11.2	4.6
SG&A expenses	159.3	167.7	(8.4)	(5.0)
R&D expenses	43.9	48.5	(4.5)	(9.4)
Core operating profit	105.9	43.2	62.8	145.4
Operating profit	107.3	28.8	78.5	272.6
Net profit attributable to owners of the parent	106.9	23.6	83.2	352.2

Segment Results

By segment on a core basis, North America revenue rose 34.2% to 337.9 billion yen and core segment profit increased significantly to 75.7 billion yen on revenue-driven growth in gross profit. In Japan, revenue declined 7.5% to 92.4 billion yen, but core segment profit rose to 12.4 billion yen thanks to SG&A expense reductions. Asia core segment profit decreased to 9.5 billion yen due to the partial transfer of the Asian business. From FY2026, the company will move from regional reportable segments to a single Pharmaceuticals segment, reflecting its globally integrated operations; the change has no impact on consolidated financial results.

Segment	Metric (Core Basis, Billions of JPY)	FY2025	FY2024
Japan	Revenue	92.4	99.8
Japan	Core segment profit	12.4	11.4
North America	Revenue	337.9	251.8
North America	Core segment profit	75.7	42.6
Asia	Revenue	23.0	47.2
Asia	Core segment profit	9.5	23.9

Among major products in North America, ORGOVYX revenue jumped to $1,029 million (155.0 billion yen, up 86.6% in yen terms) and GEMTESA rose to $637 million (96.0 billion yen, up 46.0%), while APTIOM declined to $99 million due to loss of exclusivity. One-time items included $100 million in sales milestone revenue from ORGOVYX (sales exceeding $500 million) and $88 million in deferred revenue from the collaboration with Pfizer. In Japan, TWYMEEG grew 39.0% to 10.6 billion yen, whereas Equa/EquMet fell 64.9% to 8.7 billion yen due to loss of exclusivity (discontinued in December 2025), and XEPLION/XEPLION TRI transitioned to in-house distribution in January, contributing 3.2 billion yen.

Product (North America)	FY2025 (Millions of USD)	FY2024 (Millions of USD)	FY2025 (Billions of JPY)
ORGOVYX	1,029	544	155.0
MYFEMBREE	96	84	14.4
GEMTESA	637	431	96.0
RETHYMIC	42	45	6.3
APTIOM	99	258	14.9
Total (incl. others)	2,245	1,650	337.9

FY2026 Forecast

For FY2026, the company forecasts revenue of 540.0 billion yen (up 19.1%), core operating profit of 91.0 billion yen (down 14.1%), operating profit of 90.0 billion yen (down 16.2%), and net profit attributable to owners of the parent of 77.0 billion yen (down 27.9%). U.S. revenue is expected to increase by 84.6 billion yen on continued growth of ORGOVYX and GEMTESA, incorporating ORGOVYX sales milestone revenue of $325 million (sales exceeding $1.0 billion), with ORGOVYX product sales forecast at $1,354 million and GEMTESA at $686 million (U.S. total: $2,622 million, or 406.4 billion yen). The profit decline mainly reflects the absence of the prior year’s gain on the partial transfer of the Asian business, as others (core basis) falls from 52.3 billion yen to 2.0 billion yen. R&D expenses are planned to rise 16.0% to 51.0 billion yen to accelerate development of oncology products and advance CNS programs. Cost of sales incorporates a certain level of risk related to tariffs and inflation. The forecast assumes 1US$ = ¥155.00, with ROE of 20.3% and ROIC of 15.1%.

Item (Core Basis, Billions of JPY)	FY2026 Forecast	FY2025 (Actual)	Change (%)
Revenue	540.0	453.3	19.1
Gross profit	295.0	256.9	14.8
SG&A expenses	155.0	159.3	(2.7)
R&D expenses	51.0	43.9	16.0
Core operating profit	91.0	105.9	(14.1)
Operating profit	90.0	107.3	(16.2)
Net profit attributable to owners of the parent	77.0	106.9	(27.9)

Shareholder Returns and Financial Position

The shareholder returns outlook for FY2026 is undetermined. The company states that the decision will be based on future business performance, with cash flow and financial condition, including the equity ratio, as key decision factors. Following the financial restructuring (equity financing and refinancing), the company achieved record-high earnings and executed a public equity offering; borrowings are now free of debt guarantees, and a pathway has been defined toward replacement of subordinated debt. Equity attributable to owners of the parent increased from 169.5 billion yen to 292.5 billion yen, the equity ratio improved from 22.8% to 36.4%, and bonds and borrowings decreased by 88.2 billion yen to 217.2 billion yen. For FY2026, the company plans R&D investment of JPY 51 billion and capital expenditure/investments and loans of JPY 12 billion.

R&D Topics

In March 2026, the company obtained conditional and time-limited approval in Japan for AMCHEPRY, allogeneic iPS cell-derived dopaminergic neural progenitor cells for Parkinson’s disease (in collaboration with RACTHERA), with the first transplantation in the post-marketing clinical study planned in 2026. Also in March 2026, DSP-3077 (allogeneic iPS cell-derived retinal sheet) was granted Orphan Drug Designation by the U.S. FDA for retinitis pigmentosa. In oncology, enzomenib (selective menin inhibitor) is in Phase 2 for acute leukemia with an NDA filing targeted for Q1 FY2027, and interim Phase 1/2 data for nuvisertib in combination with momelotinib are planned for presentation at the European Hematology Association meeting in June 2026. For GEMTESA, demand is growing strongly, and the company notes progress toward achieving sales of JPY 150 billion in the 2030s.

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