Otsuka Holdings Co., Ltd.
4578・Prime Market・Pharmaceuticals
Business
Otsuka Holdings is a global healthcare group composed of 181 subsidiaries and 26 affiliated companies. With healthcare at its core, the group comprises: (1) the Pharmaceutical Business, handling prescription drugs and IV fluids in the psychiatric/neurological, oncology, and cardiovascular fields (approximately 70% of revenue); (2) the Nutraceuticals Business, which develops science-based functional foods and supplements such as Pocari Sweat and Nature Made for global markets (approximately 23%); (3) consumer-facing businesses such as Crystal Geyser and Bon Curry; and (4) Other Businesses, including chemicals, measuring instruments, and logistics. With Japan, the United States, Europe, and Asia as its main markets, the group addresses a wide range of health needs, from disease treatment to prevention and health promotion.
Business Model
In the Pharmaceutical Business, patent-protected prescription drugs such as Rexulti and Abilify Maintena are sold in the US, Europe, and Japan, securing high profit margins. In the Nutraceuticals Business, functional foods and supplements leveraging science and know-how cultivated in the pharmaceutical business are deployed globally, with brand strength serving as a revenue source. By continuously investing in R&D expenses (¥352,838 million) to enrich the pipeline, the company maintains a structure in which the revenue gap after loss of exclusivity (LOE) is offset by next-generation product lineups.
Company Strengths
The antipsychotic drug Rexulti achieved FY2025 revenue of ¥331,338 million (up 23.9% year on year). In addition to its indications for major depressive disorder and agitation associated with Alzheimer's-type dementia in the U.S., the same agitation indication was approved in Japan in September 2024, prompting reinforced information-provision activities. As a single product, it has become the primary growth driver of the Pharmaceutical Business.
R&D expenses in FY2025 totaled ¥352,838 million (up 12.3% year on year), representing approximately 14.3% of revenue. The Next 8 products (centanafadine, zipalertinib, urotoralant, etc.) have advanced to the approval-application and Phase III stages. Voyzact (cibeprelimab) received accelerated approval in the U.S. in November 2025, giving concrete form to next-generation revenue sources.
Cash and cash equivalents at the end of FY2025 stood at ¥534,645 million, substantially exceeding total bonds and borrowings of ¥127,007 million, putting the company in a virtually debt-free position. With total equity of ¥3,099,761 million and operating cash flow of ¥403,579 million, the company has the financial strength to fund continued R&D investment on the scale of ¥300 billion as well as active M&A activity from its own resources.
ENVALITH's Perspective
Performance Trend
Revenue rose for five consecutive periods, from ¥1,498,276 million in FY2021 to ¥2,468,892 million in FY2025. In Q1 FY2026 (ending December 2026), revenue reached ¥630,342 million (up 8.2% year on year), with growth achieved across all segments. Quarterly profit attributable to owners of the parent was also strong at ¥98,348 million (up 15.7% year on year). However, the full-year business profit forecast of ¥355,000 million represents a substantial year-on-year decline of 20.4%, reflecting a structure in which the revenue decline caused by the Samsca/Jynarque (tolvaptan) LOE and the increase in R&D expenses (¥82,101 million in Q1 FY2026, up 4.7% year on year) are weighing on profit. As an external factor, foreign exchange (yen depreciation) is providing a tailwind for the yen conversion of overseas revenue, with a positive contribution of ¥23,624 million from foreign currency translation adjustments on foreign operations confirmed in comprehensive income for Q1 FY2026.
Growth Strategy
Under the 4th Medium-Term Management Plan, the company is advancing the launch of the Next 8 products, expanding into new business domains, and strengthening shareholder returns.
Rexulti achieved growth in prescription volume in the US and Japan following the expansion of its indication to agitation associated with Alzheimer's-type dementia, with revenue of ¥94,956 million (up 25.5% year on year) in Q1 of the fiscal year ending December 2026. Lonsurf also performed solidly at ¥25,766 million (up 6.2% year on year), supported by increased recognition of its combination therapy with bevacizumab for colorectal cancer.
Development expenses increased for urotralont (major depressive disorder, US), ASTX030 (hematologic malignancies), repinatrabit (phenylketonuria), and others. On the other hand, development of urotralont (major depressive disorder), OPC-214870 (epilepsy), and TAS1553 (acute myeloid leukemia) was discontinued for strategic reasons. Dawnzera (hereditary angioedema) received approval in Europe in January 2026.
Agreement reached on March 27, 2026. The acquisition brings TSND-201 (a fast-acting neuroplastogen with methylone as its active ingredient), expanding the portfolio in the psychiatric and neurological area. Consideration comprises US$700 million upon completion plus up to US$525 million in earnout payments. The acquisition is expected to close during Q2 of FY2026.
All three categories—For Climate & Environmental Risk (including Pocari Sweat/OS-1), For Women's Health (including Equelle/Bonafide), and For Healthier Life (including Nature Made/MegaFood/Calorie Mate)—achieved revenue growth in Q1 of the fiscal year ending December 2026. The new product "/zeroz" was launched in March 2026, expanding the Healthier Life category.
Share buybacks resolved on February 13, 2026 were carried out, with ¥8,442 million acquired in Q1 of the fiscal year ending December 2026. The full-year dividend forecast for the fiscal year ending December 2026 remains unchanged at ¥140 (same as the previous fiscal year). Dividend payments of ¥37,496 million were made in Q1 of the fiscal year ending December 2026. Basic earnings per share forecast, taking into account the impact of the share buyback, is ¥504.94.
Last updated: July 17, 2026