Ono Pharmaceutical (4528): FY2025 Results Summary — Record Profit, Lower FY2026 Guidance on Forxiga Co-Promotion End

This article is based on publicly available IR materials and is not a recommendation to buy or sell any specific securities.

Ono Pharmaceutical reported record-high revenue and profit for FY2025 (fiscal year ended March 2026). Revenue rose to JPY 515.8 billion (+5.9% YoY), driven by strong growth in overseas products, and core operating profit increased to JPY 137.1 billion (+21.7% YoY) on improved cost efficiency. Core profit attributable to owners of the Company reached JPY 103.5 billion (+14.5% YoY), the highest level since the introduction of core indicators in FY2025. For FY2026, the Company forecasts lower revenue and profit, with revenue expected to fall to JPY 455.0 billion (-11.8% YoY) mainly due to the termination of the co-promotion agreement with AstraZeneca for Forxiga, while continuing R&D investment at approximately 30% of net sales.

Consolidated Results (Full-Year Actual)

Although sales of OPDIVO decreased amid an intensified competitive environment, overall revenue increased by JPY 28.9 billion year on year, mainly due to higher royalty revenue associated with OPDIVO and other products and revenue from Deciphera Pharmaceuticals, Inc. Regarding the profit and loss recognition for Deciphera, nine months were recorded in FY2024, while twelve months were recorded in FY2025.

Item (JPY bn)	FY2025	FY2024	Change	Change (%)
Revenue	515.8	486.9	28.9	5.9%
Cost of sales	107.0	106.9	0.2	0.2%
R&D expenses	145.1	143.3	1.8	1.2%
SG&A expenses	123.6	122.2	1.4	1.1%
Core operating profit	137.1	112.7	24.5	21.7%
Core profit before tax	138.3	113.9	24.4	21.4%
Core profit for the year (attributable to owners of the Company)	103.5	90.4	13.1	14.5%

Segment Results (Sales Revenue by Product)

Sales revenue of domestic products is shown on a gross sales basis (shipment price), and sales revenue of overseas products is shown on a net sales basis. In Japan, OPDIVO Intravenous Infusion and FORXIGA Tablets sales declined, while BRAFTOVI Capsules and VELEXBRU Tablets grew. Overseas, QINLOCK sales rose sharply, and ROMVIMZA, newly launched, contributed JPY 8.3 billion. Royalty revenue from OPDIVO and KEYTRUDA also increased.

Product / Item (JPY bn)	FY2025	FY2024	Change	Change (%)
OPDIVO Intravenous Infusion (Japan)	114.3	120.3	-6.0	-5.0%
FORXIGA Tablets (Japan)	88.2	89.6	-1.4	-1.5%
ORENCIA for Subcutaneous Injection (Japan)	26.6	26.6	-0.0	-0.0%
GLACTIV Tablets (Japan)	13.2	18.3	-5.1	-27.9%
VELEXBRU Tablets (Japan)	11.9	10.5	1.4	12.8%
ONGENTYS Tablets (Japan)	9.0	7.6	1.3	17.3%
PARSABIV Intravenous Injection (Japan)	9.0	8.4	0.6	6.6%
KYPROLIS for Intravenous Infusion (Japan)	7.5	8.6	-1.1	-12.9%
BRAFTOVI Capsules (Japan)	5.6	4.2	1.4	33.8%
OPDIVO (Overseas)	14.2	13.1	1.0	8.0%
QINLOCK (Overseas)	38.4	25.5	12.9	50.6%
ROMVIMZA (Overseas)	8.3	N/A	－	－
OPDIVO Royalty	122.3	113.0	9.3	8.2%
KEYTRUDA Royalty	29.5	26.4	3.0	11.4%

FY2026 Forecast

Revenue is expected to be JPY 455.0 billion (-11.8% YoY), mainly due to the termination of the co-promotion agreement with AstraZeneca for Forxiga. The Company plans to continue investing in research and development at approximately 30% of net sales in order to advance global clinical trials aimed at expanding its pipeline. The financial forecast assumes an exchange rate of ¥155 per US dollar.

Item (JPY bn)	FY2026 Forecast	FY2025 Actual	Change	Change (%)
Revenue	455.0	515.8	-60.8	-11.8%
Cost of sales	84.0	107.0	-23.0	-21.5%
R&D expenses	143.0	145.1	-2.1	-1.5%
SG&A expenses	101.0	123.6	-22.6	-18.3%
Core operating profit	124.0	137.1	-13.1	-9.6%
Core profit before tax	124.0	138.3	-14.3	-10.3%
Income tax expense	31.0	34.6	-3.6	-10.5%
Core profit for the year (attributable to owners of the Company)	93.0	103.5	-10.5	-10.1%

The Company expects a structural shift toward its global business. Within FY2026 forecast revenue of JPY 455.0 billion, Japan sales are expected to account for 43% of revenue (down from 53% in FY2025 actual), royalty and others for 41% (up from 34%), and global sales excluding Japan for 16% (up from 13%).

Shareholder Returns

Dividends are to be paid out in accordance with a progressive policy of maintaining or increasing the annual dividend each year, with a target payout ratio of 40%, taking into account the performance of each fiscal year and various indices. The annual dividend for FY2026 is planned at 80 JPY/share. The Company’s capital allocation also includes flexible share buybacks alongside R&D and strategic investments such as M&A, pipeline acquisition, geographical expansion, and venture investment.

Item	FY2021	FY2022	FY2023	FY2024	FY2025 (Planned)	FY2026 (Planned)
Interim dividend (JPY)	28.0	37.0	40.0	40.0	40.0	40.0
Year-end dividend (JPY)	28.0	33.0	40.0	40.0	40.0	40.0
Annual dividend (JPY)	56.0	70.0	80.0	80.0	80.0	80.0
Dividend payout ratio (consolidated)	34.5%	30.3%	30.0%	75.1%	53.9%	52.9%

R&D Pipeline Progress

The Company continues to advance its pipeline across the priority areas of oncology, immunology & inflammation, and neurology. In FY2026, it plans to initiate three global Phase 3 trials and to report data readouts from seven proof-of-concept (POC) studies; four new pipeline candidates have already advanced into Phase 1 trials. Tirabrutinib, an oral BTK inhibitor for relapsed or refractory primary central nervous system lymphoma (R/R PCNSL), is under review by the U.S. FDA following NDA acceptance, with a PDUFA date of December 18, 2026; the Phase 2 PROSPECT study showed an overall response rate of 67% and a complete response rate of 44%. Sapablursen has entered a global Phase 3 trial for polycythemia vera (PV). ROMVIMZA, approved in the U.S. (FDA, February 2025) and in Europe (EMA, September 2025) for tenosynovial giant cell tumor (TGCT), recorded FY2025 actual sales of JPY 8.3 billion (against a forecast of JPY 8 billion) and is forecast to reach JPY 19 billion in FY2026, with peak sales estimated at JPY 50-70 billion. Estimated peak sales for other key pipeline products include QINLOCK (GIST) at JPY 50-70 billion, Tirabrutinib (PCNSL) at JPY 20-30 billion, Sapablursen (PV) at JPY 50-100 billion, and ONO-4578 (gastric cancer) and ONO-2808 (multiple system atrophy) each at JPY 100 billion or more.

This article is an analysis based on publicly available information and is not a recommendation to buy or sell any specific securities. Investment decisions are your own responsibility.