Ono Pharmaceutical (4528) investor relations material

Corporate overview and growth strategy

• Celebrating over 300 years, the company is expanding globally beyond Asia, aiming to become a global specialty pharma, with the 2024 Deciphera acquisition strengthening its U.S. and European presence.

• Strategic focus on oncology, immunology, inflammation, neurology, and rare diseases, targeting high unmet needs and specialty indications.

• Revenue tripled over the past decade, with FY2025 forecast at JPY 490 billion, driven by OPDIVO and Deciphera acquisition.

• R&D investment remains high, representing 30.6% of revenue, with open innovation and global partnerships to access cutting-edge technologies.

Product and pipeline highlights

• OPDIVO subcutaneous formulation launched in the U.S. and Europe, with royalties expected for 10 years post-launch; patent expirations begin in 2028 (U.S.), 2030 (Europe), and 2031 (Japan), with ongoing lifecycle management and new indications.

• Deciphera acquisition brought QINLOCK and ROMVIMZA, expanding the oncology portfolio and U.S./EU presence; QINLOCK is established as 4th-line GIST therapy, with peak sales projected at JPY 50–60 billion, and ROMVIMZA approved for TGCT with peak sales over JPY 100 billion with additional indications.

• Pipeline includes late-stage assets such as sapablursen (phase III soon, peak sales JPY 50–100 billion), ONO-2808 (phase II for MSA, potential for broader neurodegenerative indications), and ONO-4578 (EP4 antagonist, promising phase II data in gastric and colorectal cancer, with peak sales for both ONO-2808 and ONO-4578 estimated at JPY 100 billion each).

• Multiple product launches and new indications are planned through FY2031, aligning with OPDIVO patent expirations.

Financial outlook and capital allocation

• Revenue forecast anticipates offsetting OPDIVO patent expiries through new product launches and Deciphera product growth.

• R&D investment to remain around JPY 150 billion annually, with a capital allocation plan of JPY 350 billion for R&D and JPY 250 billion for strategic investments through FY2026.

• Commitment to progressive dividends with a 40% payout ratio and flexible share buybacks.

• Continued capacity for M&A and pipeline expansion to enhance corporate value.