ENVALITH
持田製薬株式会社 logo

Mochida Pharmaceutical Co.,Ltd.

4534Prime MarketPharmaceuticals

持田製薬株式会社 logo
Mochida Pharmaceutical Co.,Ltd.4534

Business

Mochida Pharmaceutical, founded in 1913 and listed on the Tokyo Stock Exchange Prime Market, operates a Pharmaceutical Business (approximately 93% of net sales) and a Healthcare Business (approximately 7%). In the Pharmaceutical Business, the company prioritizes the cardiovascular, gastrointestinal, obstetrics/gynecology, and psychiatric fields, with new drugs such as Treprost (Pulmonary Arterial Hypertension / Pulmonary Hypertension Associated with Interstitial Lung Disease Treatment), Uriadec (Gout / Hyperuricemia Treatment), Lialda (Ulcerative Colitis Treatment), and Goofis (Chronic Constipation Treatment) serving as core products. In the Healthcare Business, the company operates two major brands: the antifungal shampoo "Collage Furufuru" and the basic skincare line "Collage Repair" (Healthcare Products). The group consists of 6 consolidated subsidiaries and 1 equity-method affiliate, and takes a vertically integrated structure in which manufacturing is outsourced to its subsidiary, Mochida Pharmaceutical Factory Co., Ltd.

Business Model

The company develops and sells new drugs and biosimilars mainly through technology licensing from domestic and overseas pharmaceutical companies, thereby diversifying the risk of drug price revisions. Manufacturing is outsourced to subsidiaries, while sales are conducted through MR activities targeting medical institutions and a distribution network via wholesalers. The company has a high degree of dependence on four major wholesalers (Mediceo 24.1%, Alfresa 15.5%, Suzuken 14.8%, Toho Yakuhin 8.8%). The Healthcare business conducts consumer sales built on support from dermatologists and obstetrics/gynecology physicians, forming a stable revenue source.

Company Strengths

In FY2026 (ending March 2026), multiple flagship new drugs grew simultaneously—Treprost (Pulmonary Arterial Hypertension / Pulmonary Hypertension Associated with Interstitial Lung Disease Treatment) (+47% year on year), Uriadec (Gout / Hyperuricemia Treatment) (+36%), Lialda (Ulcerative Colitis Treatment) (+11%), and Goofis (Chronic Constipation Treatment) (+8%)—achieving pharmaceutical-related business net sales of ¥109,042 million (+11.3% year on year) while curbing dependence on any specific product. The company has established a product portfolio that can absorb the impact of drug price revisions through volume growth in new drugs.

The company holds multiple technology licensing agreements with leading domestic and international pharmaceutical companies, including Bayer (Dienogest), United Therapeutics (Treprost), Takeda Pharmaceuticals (Lialda), and Eli Lilly Japan (Omvoh). In FY2025, new agreements were also concluded with Duchesnay (a treatment for morning sickness) and LG Chem (Dienogest expansion in South Korea and Thailand), continuing to expand its alliance foundation.

As of the end of FY2026 (ending March 2026), total net assets stood at ¥140,326 million, maintaining a high equity ratio of 76.8%. Capital expenditures of ¥1,812 million were funded entirely from internal resources, and the company possesses the financial strength to cover the FY2025-2027 medium-term management plan's targets of ¥36.0 billion in R&D expenses and ¥5.0–10.0 billion in capital expenditures through a combination of retained earnings and borrowings.

ENVALITH's Perspective

In FY2026 (ending March 2026), the company achieved a significant profit increase, with operating profit of ¥10,147 million (+24.9% YoY) and ordinary profit of ¥11,195 million (+38.8% YoY), making the recovery trajectory toward the FY2022 peak (operating profit of ¥14,392 million) more evident. However, structural downward pressures—annual drug price revisions and the selected medical care system for long-listed products—continue every fiscal year, and whether growth from new drugs can keep exceeding these pressures will determine the sustainability of profit levels. The FY2027 (ending March 2027) forecast of operating profit at ¥10,500 million (+3.5% YoY) shows profit growth slowing relative to the revenue growth rate (+7.7%), and it should be noted that the increase in R&D expenses (from ¥12,157 million to a forecast of ¥14,500 million) constrains profit expansion.

Operating cash flow in FY2026 (ending March 2026) deteriorated significantly to ¥(7,350) million, down from +¥9,354 million in the previous period. The main cause was a ¥10,982 million increase in advance payments, resulting in a cash outflow exceeding the scale of net income before income taxes of ¥11,171 million. Since the content, recovery timing, and nature of the advance payments have not been disclosed, it is difficult to judge whether this represents a temporary transaction prepayment or an ongoing cash disbursement. Confirming the recovery of operating CF from the next period onward will be an important checkpoint for investment decisions.

Pipeline progress has been steady, including the filing for approval of MD-712 (for pulmonary hypertension, inhaled powder formulation) in April 2026, the approval acquisition of Tocilizumab BS "MA" in March 2026, and the submission of a clinical trial notification for HLC-001 (cell medicine) in January 2026. In the biomaterials business, Cartilage Repair Material Mochigel launched in December 2025. On the other hand, R&D expenses are expected to increase substantially to ¥14,500 million (11.5% of net sales) in FY2027 (ending March 2027), indicating that the investment-ahead phase continues. Assessing the timeline over which these investments will translate into medium-term earnings will be central to valuation judgments.

Growth Strategy

Under the 3-year mid-term plan for FY25-27, "Three Years of Accelerating Growth Strategy," the company is pursuing both strengthening core earnings and investing in next-generation businesses.

New drugs including Goofis, Uriadec, Treprost, Onbo, and Colecheme have driven business performance. Continued growth of these new drugs is expected in FY2027 (ending March 2027) as well. In parallel, deepening market penetration of the flagship pharmaceuticals Epadel and Dienogest is also being promoted.

Tocilizumab BS "MA" (for rheumatoid arthritis, etc.) received approval in March 2026. "Ethyl Icosapentate 'Mochida'" was launched in December 2025. Overall net sales of Generic Drugs (Including Dienogest Formulations) are expanding, up +12% YoY (equivalent to ¥35.1 billion). For FY2027 (ending March 2027), growth of +22% (equivalent to ¥42.7 billion) is expected.

An inhaled treprostinil dry powder formulation licensed from United Therapeutics. A manufacturing and marketing approval application was filed in April 2026. Following approval, the product lineup in the pulmonary hypertension area is expected to be strengthened together with the existing Treprost (Pulmonary Arterial Hypertension / Pulmonary Hypertension Associated with Interstitial Lung Disease Treatment).

Cartilage Repair Material Mochigel (Medical Device) received approval in July 2025 and was launched in December 2025. dMD-002, a treatment material for cavernous nerve injury, is at the confirmatory clinical trial stage domestically, and in the U.S., an exploratory clinical trial application was filed with and accepted by the FDA in February 2026. dMD-003, an anti-adhesion material, is also at the confirmatory clinical trial stage. These are being developed as a pillar for the next generation.

Multiple alliances have been concluded, including the succession of manufacturing and marketing approval for Uriadec (Gout / Hyperuricemia Treatment) (contract with Fuji Pharma, March 2026), expansion of Dienogest into South Korea and Thailand (contract with LG Chem), a development and marketing contract in Japan for Bonjesta (with Duchesnay Inc.), and a development and marketing contract in Japan for follitropin alfa BS (with Qilu Pharmaceutical). Following the conversion of Andpharma Co., Ltd. into an equity-method affiliate, equity in earnings of affiliates of ¥793 million was recorded.

Concentrated investment is being made in drug discovery research for siRNA therapeutics. For the cell therapeutic HLC-001 (for non-infectious pulmonary complications after hematopoietic stem cell transplantation), a clinical trial notification for a Phase III trial was submitted in January 2026. R&D expenses are expected to increase to ¥14,500 million (11.5% of net sales) in FY2027 (ending March 2027). This represents an upfront investment phase aimed at strengthening future competitiveness.

Last updated: July 19, 2026