SanBio Company (4592) investor relations material

Executive summary

• Achieved major milestone with AKUUGO® (formerly SB623) receiving conditional approval in Japan for motor disability from TBI in July 2024, with full shipment approval in December 2025 after 25 years of development.

• Two new executive officers joined to strengthen production, regulatory, and quality functions, enhancing leadership and compliance.

• Japan positioned as the R&D and commercial hub, with infrastructure and expertise development in regenerative medicine and AKUUGO® administration.

• Strategic focus on Japan, the U.S., and new indications such as stroke, with clinical trial expansion and global growth initiatives.

• Significant R&D investment and preparations for manufacturing, logistics, and sales infrastructure to support AKUUGO® rollout.

Financial highlights

• R&D expenses for FY ending January 2026 were ¥2,678 million, mainly for AKUUGO® approval activities, consistent with the previous year.

• Cash and equivalents stood at about ¥15,083 million as of January 31, 2026, following major financing activities including new share issuances.

• Operating revenue increased to ¥3,516 million, with operating expenses at ¥3,794 million.

• Net income improved from a loss of ¥2,882 million to a loss of ¥960 million year-over-year, but comprehensive income remained negative.

• No dividends declared for FY2026.1; no dividend forecast for FY2027.1.

Outlook and guidance

• FY2027.1 forecast: R&D expenses of ¥4,110 million, operating expenses of ¥5,625 million, and net loss of ¥5,635 million, reflecting continued investment in AKUUGO® and pipeline development.

• No operating revenue from AKUUGO® included in forecast pending price determination.

• Focused on manufacturing, distribution, sales, and data collection to support full approval and future launches.