ENVALITH
日本新薬株式会社 logo

Nippon Shinyaku Co.,Ltd.

4516・Prime Market・Pharmaceuticals

Official website
日本新薬株式会社 logo
Nippon Shinyaku Co.,Ltd.4516

Business

Nippon Shinyaku Co., Ltd. is a pharmaceutical company headquartered in Kyoto, founded in 1911, operating two segments: the Pharmaceuticals Business and the Functional Foods Business. In the Pharmaceuticals Business, the company sells domestically and internationally a lineup of products specialized in intractable and rare disease areas, including Uptravi (Selexipag) for pulmonary arterial hypertension, Fintepla (Fenfluramine Hydrochloride) for rare epilepsy, and Viltepso (Viltolarsen) for Duchenne muscular dystrophy, with royalty income from overseas partners also serving as a major revenue source. In the Functional Foods Business, the company provides functional food ingredients and finished products leveraging the high quality and quality control know-how of a pharmaceutical company. Group-wide revenue, including 6 consolidated subsidiaries, reached ¥170,771 million in FY2026 (ending March 2026), with the company advancing global expansion with bases in the US, China, and Europe.

Business Model

In the Pharmaceuticals Business, the company builds its product portfolio through both in-house drug discovery and external licensing, accumulating royalty and milestone income (Industrial Property Rights Revenue (Royalty)) from overseas partners such as Uptravi (Selexipag), in addition to domestic sales revenue. In FY2026 (ending March 2026), Industrial Property Rights Revenue (Royalty) is projected at ¥49,457 million, accounting for approximately 33% of Pharmaceuticals segment sales, functioning as a high-margin revenue source. The Functional Foods Business provides pharmaceutical-grade ingredients and finished products, complementing earnings with stable revenue.

Company Strengths

Industrial Property Rights Revenue (Royalty), centered on royalty and milestone income linked to overseas sales of Uptravi (Selexipag), reached ¥49,457 million in FY2026 (ending March 2026), accounting for approximately 33% of Pharmaceuticals segment revenue of ¥148,484 million. As high-margin revenue without accompanying manufacturing costs, it serves as a structural strength that mitigates the impact of domestic drug price revisions.

The company focuses on four therapeutic areas—hematology, intractable and rare diseases, urology, and gynecology—advancing development through three pillars: proprietary drug discovery, in-licensing, and PLCM (Product Life Cycle Management). As of the end of FY2026 (ending March 2026), multiple new product candidates are in stages ranging from late-stage clinical development to launch, including the launch of NS-401 (Taglaxofusp), FDA review of CAP-1002 (Deramiocel) (PDUFA date: August 22, 2026), and the in-licensing of gene therapies such as ATSN-101, RGX-121, and RGX-111. R&D expenses stood at ¥36,713 million (21.5% of revenue), reflecting continued aggressive investment.

Against total assets of ¥346,359 million at the end of FY2026 (ending March 2026), equity attributable to owners of the parent stood at ¥291,551 million, maintaining an equity ratio of over 84%. The company covers both working capital and capital expenditure needs entirely through internal funds, maintaining a financial structure that does not rely on external borrowing. Cash and cash equivalents stood at a robust ¥76,592 million, ensuring flexibility for strategic in-licensing investments and R&D investment.

ENVALITH's Perspective

FY2026 (ending March 2026) achieved revenue growth of +6.6%, but net income attributable to owners of parent decreased 8.7% year-on-year to ¥29,721 million. The main cause was income tax expense nearly doubling from ¥3,574 million to ¥6,734 million. Operating profit was ¥35,496 million, essentially flat year-on-year (+0.1%), as increases in selling, general and administrative expenses (+14.6%) and R&D expenses (+6.9%) offset the effect of higher revenue. For FY2027 (ending March 2027), operating profit of ¥38,000 million (+7.1%) and net income of ¥30,300 million (+1.9%) are forecast, but the continuation of the rising cost trend constrains margin improvement.

Achieving the FY2027 (ending March 2027) revenue forecast of ¥200,000 million (+17.1%) hinges on Deramiocel (CAP-1002) (US) contributing ¥11,400 million and Erleada (Prostate Cancer Treatment) contributing ¥14,400 million (+141% year-on-year). Deramiocel (CAP-1002) (US) has a PDUFA date of August 22, 2026, and FDA approval or rejection is a key premise of the earnings forecast. Meanwhile, as a subsequent event, a lawsuit has been filed by Capricor seeking, among other things, termination of the sales agreement (May 7, 2026), creating uncertainty over the feasibility of approval and commercialization. The outcome of this lawsuit is the largest risk factor determining whether the FY2027 forecast can be achieved.

Industrial Property Rights Revenue (Royalty) accounts for approximately 29% of revenue, with its core being overseas sales-linked income from Uptravi (Selexipag). Uptravi's patent life and the timing of generic entry will determine mid- to long-term revenue sustainability. Domestic Uptravi (Selexipag) sales in FY2026 (ending March 2026) were strong at ¥17,593 million (+17.5%), but cultivating successor products is an urgent task. New product lines such as Fintepla (Fenfluramine Hydrochloride) (+92.5%) and Erleada (Prostate Cancer Treatment) are emerging as alternative revenue sources, but it is expected to take time before they can fully offset the scale of royalty income.

Growth Strategy

Aiming for FY2027 (ending March 2027) sales of ¥200,000 million through three pillars: launch of new product lineup, expansion of royalty income, and pipeline expansion

Recognition as product sales began in October 2025 based on contract revisions. FY2026 (ending March 2026) was limited to ¥5,961 million (half-year portion), but FY2027 (ending March 2027) is projected at ¥14,400 million (+141%). Stable demand is expected as a Prostate Cancer Treatment.

Capricor submitted Phase III trial data to the FDA and the review has resumed. The PDUFA date is August 22, 2026. Under the contract, Nippon Shinyaku will handle US sales after approval is obtained. ¥11,400 million is projected for FY2027 (ending March 2027), but uncertainty has increased due to the lawsuit filed by Capricor (May 7, 2026).

Uptravi recorded ¥17,593 million (+17.5%) in FY2026 (ending March 2026), with FY2027 (ending March 2027) projected at ¥19,200 million. Fintepla recorded ¥3,980 million (+92.5%) in FY2026 (ending March 2026), with FY2027 (ending March 2027) projected at ¥6,100 million. Industrial Property Rights Revenue (Royalty) is also expected to expand to a projected ¥53,000 million in FY2027 (ending March 2027).

Chugai Pharmaceutical filed an application for indication expansion for idiopathic nephrotic syndrome in May 2026. A Phase III trial targeting lupus nephritis and systemic lupus erythematosus is also underway. Obtaining approval will expand the revenue base of existing products.

NS-089 (DMD, exon 44 skipping) is undergoing a global Phase II trial and has already obtained US Breakthrough Therapy designation. NS-229 (EGPA, JAK1 inhibitor) has already obtained US Fast Track designation and is undergoing a global Phase II trial. NS-863 (pulmonary hypertension) is in preparation for a global Phase II trial.

Last updated: July 19, 2026