PharmaEssentia’s novel therapy Ropeginterferon alfa-2b (Ropeg) for polycythemia vera (PV) continues to drive global sales growth, with second-quarter operating profit surging 147.57% year-over-year and earnings per share (EPS) reaching NT$2.50. At an investor conference on August 14, the management team noted that revenue is expected to keep rising quarter by quarter in the second half of the year. Ropeg is also advancing international market penetration, with regulatory approval in Mexico anticipated this year for PV, while simultaneously moving into the essential thrombocythemia (ET) market. PharmaEssentia has applied for Ropeg to be included in the U.S. National Comprehensive Cancer Network (NCCN) treatment guidelines, a move that would improve clinical accessibility, expand coverage, and potentially accelerate regulatory reviews.
In Q2, revenue reached NT$3.60 billion, up 10.6% quarter-on-quarter and 56.19% year-on-year, marking the ninth consecutive quarterly record high. Operating profit rose to NT$1.10 billion, up 147.57% year-on-year. Although foreign exchange losses of NT$1.17 billion weighed on pretax profit, tax benefits of NT$740 million helped net income reach NT$830 million, up 22.42% from a year earlier, with EPS at NT$2.50. For the first half, cumulative revenue hit NT$6.86 billion, up 73.23% year-on-year, with operating profit at NT$2.20 billion (up 378.31%), net profit at NT$2.10 billion (up 107.46%), and EPS of NT$6.30.
The company emphasized that both revenue and profit are maintaining strong growth momentum with consistently high margins. With prudent cost management and an expanded sales force, profitability is expected to strengthen further in the second half of the year.
To boost physician adoption, PharmaEssentia launched multiple peer-to-peer (P2P) educational programs in Q2, which significantly enhanced doctors’ recognition of Ropeg as a first-line PV treatment. The U.S. and Japan have completed major expansions of their marketing and sales teams, growing by 65% and 45% respectively since Q1, while pushing forward with omnichannel marketing to enhance physician education, training, and market reach.
Globally, Ropeg is now approved and marketed in nearly 50 countries for PV. In Q2, PharmaEssentia secured approval in Argentina and filed applications in Vietnam and Canada, with Mexico expected to follow shortly. Canada recently classified Pegasys supply disruptions as a Tier 3 Drug Shortage—the most severe level—and, through local distributor Forus, Ropeg has already entered the Canadian market and begun contributing to revenue.
In Japan, PharmaEssentia has applied to update the product label to include a higher-dose regimen, which is expected to increase shipments and sales. In South Korea, Ropeg has been re-submitted for national health insurance coverage and may be granted reimbursement as early as Q3, enabling more PV patients to access treatment.
Beyond PV, global ET regulatory submissions are advancing, with approvals targeted across multiple markets beginning in 2026. China’s National Medical Products Administration (NMPA) formally accepted the ET filing on July 16, while the U.S. submission is expected before year-end. Applications in Taiwan and Japan are also being prepared for this year.
PharmaEssentia has also submitted an application to the NCCN to include Ropeg as a recommended treatment option for ET. If accepted, Ropeg could be listed as early as this year. Because NCCN guidelines strongly influence U.S. insurance reimbursement, early inclusion could enable off-label use, special-case payment, and hospital adoption even before FDA approval, improving clinical accessibility and accelerating regulatory reviews. This would also strengthen future health technology assessment (HTA) evaluations globally.
Additionally, PharmaEssentia’s board has approved the establishment of a British Virgin Islands (BVI) subsidiary to mitigate foreign exchange risks. The BVI entity will operate in U.S. dollars, reducing the impact of NT$/USD fluctuations on consolidated earnings while leveraging tax and capital flow advantages.
The company also expects to benefit from the recently passed “One Big Beautiful Bill Act” (OBBBA) in the U.S., which allows immediate R&D expensing, restores 100% bonus depreciation for manufacturing assets, and raises the cap on deductible interest expenses. These measures are expected to lower costs and improve financial flexibility. PharmaEssentia will work with auditors to assess applicability and optimize tax filings for its U.S. subsidiaries.
Resource: 藥華藥PV新藥全球擴張營收拚逐季增，申請納NCCN推薦治療選項
