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PharmaEssentia to Apply for International Drug ApprovalsNov 18, 2024

PharmaEssentia announced on November 15 during its corporate briefing that it plans to seek international approvals for its new drug Ropeginterferon alfa-2b (Ropeg or P1101). Following its indication for polycythemia vera (PV), the drug’s second indication, essential thrombocythemia (ET), is slated for regulatory submissions in 2025 in countries including the United States, China, and Japan, with approvals anticipated in 2026. The company is actively preparing its marketing strategy, aiming to make Ropeg a new driver of growth.

Q3 Performance Highlights

PharmaEssentia recorded Q3 revenue of NT$2.71 billion, up 17.52% quarter-over-quarter and 107.5% year-over-year, marking its sixth consecutive record-breaking quarter since Q2 2023. Operating profit for Q3 reached NT$730 million, an increase of 65.98% quarter-over-quarter and NT$1.38 billion year-over-year. Net profit after tax was NT$720 million, up 5.86% quarter-over-quarter and 263% year-over-year, with earnings per share (EPS) at NT$2.21—all reaching new highs.

Since achieving its first positive operating profit milestone in Q1 2023, the company reported a 24-fold increase in Q2, followed by strong Q3 growth of nearly 66%.

Strong Global Sales of Ropeg

Sales of Ropeg for PV treatment continue to grow globally. Notably, while Q3 revenue increased by 17.52%, expenses rose only 5.59% quarter-over-quarter and declined by 9.76% year-over-year due to effective cost control measures.

Cumulative Gains in the First Three Quarters

For the first three quarters of 2023, PharmaEssentia achieved cumulative revenue of NT$6.67 billion, up 92.94% year-over-year. Through rigorous cost management, expenses decreased by 4.59% year-over-year. Operating profit surged to NT$1.19 billion, an increase of NT$2.98 billion year-over-year, while net profit reached NT$1.73 billion, equivalent to half of the company’s paid-in capital, reflecting a year-over-year increase of NT$2.47 billion. EPS for the period was NT$5.2.

PharmaEssentia emphasized that both revenue and profitability are on a strong upward trend.

Resource: 藥華新藥 申請海外藥證