Kaken Pharmaceutical (4521) Investor update summary

Business profile

• FY2026 consolidated revenue was ¥76.8bn: pharmaceuticals and medical devices 88%, agricultural chemicals 8%, and real estate and other 4%.

• Core business focuses on dermatology and orthopedics, with products developed to improve patients’ quality of life.

Core products

• FY2025 sales were ¥13.2bn for Krenafin, ¥2.3bn for Ecloc, and ¥18.4bn for Alz.

• Krenafin plus its authorized generic recorded a sales-volume index of 109% versus the prior year; the generic launched in September 2025 at half the originator’s price.

• Ecloc is Japan’s first insured topical treatment for primary axillary hyperhidrosis; its market is expanding amid awareness efforts and new treatment options.

Growth strategy and pipeline

• The 10-year plan sets ¥260bn for R&D and related investment, including ¥90bn for pipeline expansion through M&A and licensing.

• R&D targets include 8 launches in 10 years, at least 8 projects continuously from Phase I onward, and at least 1 in-licensed or partnered product annually; 5 of 10 targeted additions are for overseas development.

• Ten products had been licensed or partnered by March 2026; KP-001 received orphan-drug designation in March 2026, with a Japanese marketing application filed in May and approval targeted for H1 FY2027.

• Johnson & Johnson agreements secured upfront payments of $86m for NM26 and $30m for KP-723, with maximum milestones of $252.4m and $1.2bn, respectively, plus royalties; NM26’s atopic dermatitis Phase II trial was discontinued.

• Aadi Bioscience was acquired in March 2025, adding U.S. sales infrastructure and FYARRO, a PEComa treatment; KP-001’s U.S. Phase III trial was underway, with completion planned for February 2028.