PharmaEssentia (6446) investor relations material

Business and revenue

• Integrated biopharmaceutical operations span R&D, clinical development, manufacturing and commercialization; 2026 10M global revenue reached NTD ~22.6B, up 86% YoY.

• Q3 2026 revenue was NTD 7.76B; 9M revenue reached NTD 19.7B, surpassing FY2025 and rising 100% YoY.

ROPEG commercial reach

• ROPEG is approved in more than 50 countries for PV; Canada approval was granted July 2, 2026.

• ET approvals were granted in Taiwan on May 12, Japan on Aug. 24, the U.S. on Aug. 28 and China on Oct. 15, 2026; Korea authorization is expected in 2027.

• U.S. prevalence estimates cited: 163K PV, 170K ET and 14K pre-fibrotic/early PMF patients; total MPN market prevalence 347K.

• NCCN guidance lists ROPEG as the only preferred therapy for low-risk PV and the only preferred interferon for high-risk PV.

Clinical profile and market opportunity

• ROPEG is a predominantly single-isomer interferon with a longer half-life, every-two-week dosing and a reported low-discontinuation safety profile; it became the first FDA-approved novel long-acting interferon for PV in four decades.

• The global MPN treatment market is forecast at USD 15.33B in 2025 and USD 21.25B in 2035, with a stated 2025–2035 CAGR of 3.32%.

• HOPE-PMF Phase III enrollment completed in June 2026 with 160 patients, exceeding target; a positive DSMB recommendation supported trial continuation, with indication approval targeted for 2028.

• PMF IIT results presented at ASH, EHA and ASCO showed maintained hemoglobin, reduced blood-cell counts and other clinical, hematologic and molecular outcomes.