Ono Pharmaceutical (4528) R&D Day - ROMVIMZA presentation summary

Financial and operational highlights

• Deciphera acquisition completed in June 2024, with P/L consolidation from July 2024; single-year profitability expected in FY2027.

• QINLOCK sales reached ¥25.5B in FY2025, forecasted to grow to ¥34B in FY2026; ROMVIMZA launched in the US in February 2025.

• FY2024 product sales were ¥26.1B, with expenses at ¥42.3B; FY2025 forecast: sales ~¥40B, expenses ~¥57B.

• Integration of US and European operations into Deciphera in July 2025 to accelerate global expansion.

• Sales growth expected from global products, new launches, and continued royalties, despite upcoming patent expirations.

Product and pipeline developments

• ROMVIMZA (vimseltinib) is the first FDA-approved therapy for TGCT without a black box warning or REMS program; launched in the US, EU filing underway.

• Phase 3 MOTION study met all primary and secondary endpoints, showing significant efficacy and functional improvement in TGCT patients.

• ROMVIMZA demonstrated a 40% ORR by RECIST and 67% by Tumor Volume Score at week 25, with ~5x improvement in range of motion versus placebo.

• Well-tolerated safety profile with few discontinuations and no evidence of cholestatic hepatotoxicity.

• Phase 2 study for ROMVIMZA in chronic graft-versus-host disease (cGVHD) initiated in late 2024.

Market opportunity and commercial strategy

• US TGCT market estimated at $700M+ TAM, with 1,400 incident and 9,000 prevalent patients; no approved therapies in Europe.

• Market expansion expected through increased awareness, education, and new product launches.

• ROMVIMZA added as a preferred regimen in NCCN guidelines for soft tissue sarcoma.

• Strong early market receptivity: positive feedback from oncologists, patients, and payers; broad prescriber base and fast patient access.

• High intent among oncologists to use ROMVIMZA for TKI-naive, post-surgery, and patients discontinuing other TKIs due to toxicity.