Kyowa Kirin Co., Ltd.

Business Details

The Group consists of a single Pharmaceuticals segment. It engages globally in the research, development, manufacturing, and sale of prescription pharmaceuticals, with core focus on three disease areas: bone and mineral, hematology/oncology and rare hematologic diseases, and rare diseases (hematopoietic stem cell gene therapy). Global strategic products, centered on North America and EMEA, drove growth, and Technology Revenue (Royalties & Milestones) also increased. In Q1 FY2026 (ending March 2026), the Company achieved revenue of ¥118,467 million (up 13.1% year on year) and core operating profit of ¥20,014 million (up 78.3% year on year), representing substantial growth in both revenue and profit.

Recent Overview

In Q1 FY2026 (ending March 2026), revenue increased 13.1% and core operating profit increased 78.3%, marking substantial growth in both revenue and profit. The full-year core operating profit forecast was revised upward.

In Q1 FY2026 (ending March 2026, January–March), in addition to growth in global strategic products centered on North America and EMEA, Technology Revenue increased substantially due to the lump-sum recognition of contract liabilities following the termination of the rocatinlimab collaboration agreement, among other factors, resulting in revenue of ¥118,467 million (up 13.1% year on year). A decrease in R&D expenses also contributed, bringing core operating profit to ¥20,014 million (up 78.3% year on year). Following the decision in March 2026 to discontinue the rocatinlimab clinical trial program, related expenses will no longer be incurred going forward, and the full-year core operating profit forecast was revised upward from ¥100,000 million to ¥130,000 million (the full-year net profit forecast was maintained at ¥75,000 million). Orchard Therapeutics Limited was excluded from the scope of consolidation. The marketing authorization application for OTL-200 (Lenmeldy) in Japan was completed in March 2026.

Key Products

Growth Drivers

• Continued market penetration and indication expansion (including tumor-induced osteomalacia) for Crysvita in North America, Europe, and Japan
• Expansion of launch countries/regions and market penetration for Poteligeo (North America and EMEA)
• Expansion of U.S. sales and indications for KOMZIFTI (ziftomenib) (Phase III trial ongoing for newly diagnosed AML) and initiation of a Phase II trial in Japan
• Continued growth in Technology Revenue (royalties) from AstraZeneca (benralizumab) and others
• Completion of the Japan marketing authorization application for Libmeldy／Lenmeldy (March 2026) and expanded newborn screening following addition of MLD to the U.S. RUSP
• Boost to core operating profit from the elimination of related expenses following discontinuation of the rocatinlimab clinical trials
• Foreign exchange tailwinds to revenue and profit from a stronger British pound and euro (up ¥17 and ¥22 respectively year on year)

Risks

• Continued pressure on domestic revenue from the April 2025 drug price reduction in Japan
• Pipeline loss and increased other expenses from closing costs following the decision to discontinue all clinical trials for rocatinlimab (KHK4083) (March 2026)
• Decline in sales of existing products due to penetration of biosimilars (e.g., Ziextenzo)
• Near-term negative net profit/loss in U.S. sales of KOMZIFTI (ziftomenib) (recorded within selling, general and administrative expenses during the launch phase under the profit-share structure)
• Extremely limited number of eligible patients for Libmeldy／Lenmeldy and associated risk of quarter-to-quarter variability in prescribed patients
• Decline in royalty income following completion of the divestiture of the EMEA Established Products joint venture
• Foreign exchange risk from fluctuations in the US dollar, British pound, and euro (more than half of revenue is generated overseas)
• ROE remaining below the mid-term management plan target (10% or higher)