SanBio Company (4592) Q2 2025 earnings summary

Executive summary

• Received conditional and time-limited marketing approval in Japan for Akugo/AKUUGO®, the world's first brain regeneration drug for chronic motor paralysis from traumatic brain injury, with shipment targeted for Q1 FY2026 and global expansion plans, especially in the US.

• Strategic focus on restarting US clinical activities, re-engaging in ischemic stroke treatment, and leveraging Japan as an innovation hub.

• R&D for SB623 remained a priority, with significant expenses incurred.

Financial highlights

• Operating revenue for the six months ended July 31, 2024, was ¥1,391 thousand, down from ¥1,806 thousand year-over-year.

• Operating expenses were about ¥1.5–1.57 billion, with R&D expenses totaling approximately ¥1 billion.

• Net loss attributable to owners of parent was ¥1,309 million, improved from ¥1,787 million year-over-year.

• Cash and cash equivalents at period-end were ¥3,014–3,081 million, down from ¥4,389 million at the previous year-end.

• Net assets declined to ¥1,572 million, with equity ratio decreasing to 38.3%.

Outlook and guidance

• Plans to ship Akugo/AKUUGO® in Japan by April 2025 (Q1 FY2026), pending inventory and regulatory conditions.

• No revisions to the full-year forecast; projected net loss for FY2025 is ¥3,359 million, with no dividend planned.

• Post-marketing clinical trial required for full approval in Japan, with active patient engagement underway.

• Global expansion strategy includes restarting US initiatives and re-engaging in ischemic stroke clinical trials.