ENVALITH
キッセイ薬品工業株式会社 logo

KISSEI PHARMACEUTICAL CO., LTD.

4547・Prime Market・Pharmaceuticals

Official website
キッセイ薬品工業株式会社 logo
KISSEI PHARMACEUTICAL CO., LTD.4547

Business

Kissei Pharmaceutical is a drug discovery research and development-oriented pharmaceutical company founded in 1946, headquartered in Matsumoto City, Nagano Prefecture. Centered on its Pharmaceuticals Business, the company operates four segments: Information Services (Kissei Comtec), Construction & Facility Maintenance (Hashiba Technos), and Merchandise Sales (Kissei Shoji). In the Pharmaceuticals Business, the company focuses on urology, nephrology/dialysis, and rare disease areas, building a product portfolio that combines proprietary in-house created products with in-licensed products. In addition to domestic sales, the company also promotes overseas monetization through out-licensing of its proprietary products. Consolidated net sales for FY2026 (ending March 2026) were ¥97,406 million, with the Pharmaceuticals Business accounting for approximately 80% of the total. Listed on the Prime Market of the Tokyo Stock Exchange.

Business Model

In the Pharmaceuticals Business, the company combines small-molecule drug discovery at its own laboratories (Azumino and Joetsu) with technology in-licensed from external sources, manufacturing and selling the resulting products domestically. Products created in-house are expanded overseas through out-licensing via partners in Europe, Asia, and elsewhere, generating upfront contract payments, milestones, and royalties. The three non-pharmaceutical segments complement the Pharmaceuticals Business while also capturing internal group demand (IT and construction), forming an in-house revenue structure.

Company Strengths

Three rare disease drugs—Tavneos Capsules (Avacopan) (for microscopic polyangiitis, etc.), Korsuva IV Syringe for Dialysis (Difelikefalin) (for dialysis pruritus), and Tavalisse Tablets (Fostamatinib) (for chronic immune thrombocytopenia)—achieved combined sales of ¥15,377 million in FY2026 (ending March 2026), up 36.3% year on year. The focus on rare disease areas with high drug pricing and limited competition is enhancing the quality of earnings.

Linzagolix (Yselty) has been licensed out under four agreements, with Theramex (UK), Sinmox BioPharma (Taiwan), JW Pharmaceutical (South Korea), and Searchlight Pharma (Canada). Sales have already commenced in Taiwan and Europe as of March 2026, building up a track record of global expansion for the company's in-house discovered products.

As of the end of FY2026 (ending March 2026), the equity ratio stood at 83.7%, with net assets of ¥231,536 million and cash and cash equivalents of ¥53,971 million. With a financial structure close to debt-free, the company maintains the financial flexibility to continue active investment in R&D expenses of ¥22,521 million (23.1% of net sales) while also conducting share buybacks and dividend payments.

ENVALITH's Perspective

The operating loss for FY2026 (ending March 2026) was ¥2,927 million (a sharp reversal from an operating profit of ¥5,773 million in the previous fiscal year). Although revenue increased 10.3%, selling, general and administrative expenses rose 27.3% from ¥38,291 million to ¥48,745 million, exceeding gross profit of ¥45,818 million. The main cause of the increase was ballooning R&D expenses, including a major technology licensing deal with Viridian Therapeutics, and FY2027 (ending March 2027) is expected to return to profitability with an operating profit of ¥4,400 million as this effect reverses. However, the continued expansion of R&D investment remains a structural factor pressuring profit margins.

Profit attributable to owners of parent for FY2026 (ending March 2026) increased 15.2% year on year to ¥13,779 million, but this was the result of recording ¥17,044 million in gains on sale of investment securities as extraordinary income, resulting in a marked divergence from the operating loss of ¥2,927 million and ordinary loss of ¥1,162 million. The balance of investment securities held remains large at ¥104,271 million, leaving room for further gains on sale, but without an improvement in core business profitability, it is difficult to assess this as sustainable profit growth. It should be noted that the FY2027 (ending March 2027) forecast also includes gains on sale of investment securities within extraordinary income.

On April 27, 2026, the FDA proposed withdrawal of Tavneos's U.S. approval, and on January 30, 2026, the EMA also announced the start of a CHMP review due to concerns over the integrity of data from an international joint Phase III clinical trial. Tavneos is a core product among orphan drugs (part of the ¥15,377 million in orphan drug sales in FY2026 (ending March 2026)), and reporting to and responses to inquiries from Japan's PMDA continue. As an external factor, regulatory review trends pose a risk of directly affecting business performance, and depending on future review outcomes, there is a risk of downside to the Pharmaceuticals Business's sales and profit plans.

Growth Strategy

Under "Beyond 80," the company is pursuing five years of sustainable growth as a drug discovery R&D-oriented company and ¥30.0 billion in shareholder returns

In addition to the continued growth of Tavneos, Korsuva, and Tavalisse, the company aims to expand sales of Yselty (Linzagolix, indicated for uterine fibroids), which was newly launched domestically in March 2026. For FY2027 (ending March 2027), the company plans to achieve revenue growth in the Pharmaceuticals Business. However, the FDA/EMA review issues concerning Tavneos represent an uncertainty factor affecting plan achievement.

Olutasidenib, an acute myeloid leukemia treatment licensed in from Rigel Pharmaceuticals, is currently in preparation for domestic approval application. In May 2026, a sublicensing agreement was concluded with Orient EuroPharma (Taiwan), from which upfront and milestone payment income is expected.

Matsupexole (KDT-3594, for Parkinson's disease) achieved its primary endpoint in a late-stage Phase II clinical trial in March 2026. Domestic Phase I clinical trials for KSP-0914 (Graves' disease), KSP-0576 (overactive bladder/interstitial cystitis), and KSP-0930 (narcolepsy) were initiated during FY2026 (ending March 2026), advancing three products to the clinical stage.

Under a dividend payout ratio of 40% or more and a progressive dividend policy, the company plans an annual dividend of ¥160 per share for FY2026 (ending March 2026) (including a ¥40 commemorative dividend for the 80th anniversary) and a forecasted ¥170 per share for FY2027 (ending March 2027) (including a ¥40 commemorative dividend). Share buybacks are planned at approximately ¥6.0 billion per year, totaling ¥30.0 billion over five years, with a resolution in May 2026 to acquire up to 1,300,000 shares for up to ¥6.0 billion.

In April 2025, the company established the "Boston Open Innovation Office" in the Boston area of Massachusetts, USA. By strengthening information gathering and partnering activities in this life sciences hub, the company aims to continue securing major licensing deals, such as the agreement for two thyroid eye disease treatments with Viridian Therapeutics (July 2025).

Last updated: July 19, 2026