Zeria Pharmaceutical Co., Ltd.

Business Details

The core segment of Zeria Pharmaceutical. With ulcerative colitis treatment Asacol and Clostridioides difficile infection treatment Dificlir (domestic brand name: Dafclir) as its mainstay products, the segment is driving global expansion centered on Europe. Customers are medical institutions and physicians both domestically and overseas, with sales conducted in Europe, Asia, and other regions through an overseas subsidiary network centered on Tillotts Pharma AG (Switzerland). Management resources are concentrated in the gastrointestinal field, with a product lineup covering from the upper to lower gastrointestinal tract. The overseas sales ratio has expanded to 59.3% (56.9% in the prior period) on a consolidated basis, with this segment serving as the driving force.

Recent Overview

Sales increased on strong European performance for Dificlir and normalized Asacol supply, with the lifting of Vitasa's dosing restriction becoming a new growth axis

Sales in the Prescription Pharmaceuticals Business for FY2026 (ending March 2026) were ¥61,626 million (up 4.5% year on year). For Asacol, after the supply shortage caused by a production equipment malfunction at a manufacturing subcontractor—which persisted through the third quarter—was resolved, strong performance in overseas markets resulted in a full-year increase in sales. Dificlir sales increased 8.8%, centered on France and Germany. Meanwhile, Entocort sales declined 2.4% due to generic drug entry. In December 2025, the dosing period restriction on Vitasa was lifted, and the company began building the market in the renal, dialysis, and cardiovascular fields. For Z-338 (acotiamide), a development and sales agreement was concluded with Agastra-Lab s.r.l. for Europe, the United States, and Canada, accelerating global expansion.

Key Products

Growth Drivers

• Continued market expansion for Dificlir in major European countries (France, Germany, etc.), supported by first-line drug recommendations in European guidelines
• Strong performance for Asacol in overseas markets following supply normalization, along with enhanced European expansion
• Accelerated domestic market penetration for Vitasa (hyperkalemia treatment) following the lifting of the dosing period restriction (December 2025)
• Progress in Phase III trials and overseas expansion for acotiamide (Z-338) in Europe, the United States, and Canada with Agastra-Lab s.r.l.
• Business expansion into ASEAN countries, including the Z-338 approval application in Vietnam through Pharmaceutical Joint Stock Company of February 3rd
• Promotion of appropriate drug use activities for Feinject (iron deficiency anemia treatment) leveraging real-world data

Risks

• Continued downward pressure on domestic sales from annual domestic drug price revisions and the long-listed product selection-based medical care system (Acofide has been affected by drug price revisions)
• Risk of generic drug entry into existing products including Entocort (sales declined in the current period due to generic drug launches in some overseas countries)
• Foreign exchange risk (given the high overseas sales ratio, the company recorded a foreign exchange loss of ¥1,356 million in the current period, resulting in a 14.0% decline in ordinary profit)
• Manufacturing and supply risk, such as production equipment trouble at the Asacol manufacturing subcontractor (a supply shortage occurred through the third quarter of the current period)
• Impairment risk for intangible fixed assets such as goodwill and sales rights (sales rights balance of ¥27,089 million, goodwill balance of ¥3,028 million)
• Risk of delayed market penetration for introduced products such as Vitasa and Feinject