SanBio Company (4592) Q4 2025 earnings summary

Executive summary

• Achieved world-first and conditional approval for AKUUGO® in Japan in July 2024, targeting chronic traumatic brain injury, with commercial launch and shipment expected in Q2 FY2025 and global expansion planned.

• Strategic focus on expansion in Japan, the United States, and ischemic stroke indications, with U.S. operations restarted and clinical trials in preparation.

• Initiatives underway to establish Japan as a manufacturing and operational base, with U.S. and stroke markets as primary growth drivers.

• Focus remains on R&D, especially for SB623, and expansion into the US market with new clinical trials planned.

• Operating loss and net loss increased year-over-year, driven by high R&D expenses and limited revenue.

Financial highlights

• Operating expenses for FY2025.1 were ¥3,516 million, mainly for AKUUGO®/SB623 program activities, down ¥1,023 million year-over-year.

• Net loss attributable to owners was ¥2,882 million, compared to ¥2,644 million in the prior year.

• Cash and cash equivalents at year-end were ¥2,921 million, with an additional ¥2 billion raised post-fiscal year.

• Foreign exchange gains of ¥622 million recorded as non-operating income.

• Research and development expenses totaled ¥2,357 million.

Outlook and guidance

• Anticipates approval and market launch of AKUUGO® in Japan by end of July, with shipment release in the first half and sales launch in the second half of FY2026.1, pending successful manufacturing runs.

• Projected FY2026.1 operating expenses of ¥3,509 million, mainly for AKUUGO® approval and post-marketing activities.

• Preparing for clinical trials in ischemic stroke in both Japan and the U.S., with resumed FDA discussions for U.S. Phase III trial in traumatic brain injury.

• No dividends planned for FY2025 or FY2026 to prioritize R&D investment.