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European sales of Tuznue and expanded CDMO operations drove top-line growth, while impairment charges on intangible assets and investments in subsidiaries weighed on results; approvals in Trinidad and Tobago and Brazil support expansion into emerging markets

Prestige Biopharma achieved 76% revenue growth in fiscal 2026, which runs from July 2025 through June 2026, driven by the full-scale launch of its Herceptin biosimilar Tuznue in Europe and increased contract development and manufacturing organization (CDMO) volumes. However, the company swung to a net loss of $84.77 million (approximately 113.6 billion won) after recognizing large impairment charges on intangible assets and investments in subsidiaries. The results, which showed top-line growth alongside a book loss, are being interpreted as the outcome of accelerating entry into the global biosimilars market while recognizing accumulated accounting-related weaknesses all at once.
Tuznue and CDMO Growth Drive Revenue Surge
According to the business report disclosed by Prestige Biopharma on the 21st, consolidated revenue rose 76% to $17.98 million (approximately 24.1 billion won), from $10.21 million the previous year. The main driver of the increase was the commercialization of Tuznue (HD201) in the European market. After Tuznue received marketing authorization from the European Commission (EC) in September 2024, milestone revenue and active pharmaceutical ingredient sales began to be recognized in earnest.
Expanded CDMO revenue at subsidiary Prestige Biologics also contributed to top-line growth. Contract manufacturing volumes for global pharmaceutical companies increased, supported by the large-scale advanced manufacturing facility in Osong, North Chungcheong province. The company, headquartered in Singapore and listed on South Korea’s Korea Composite Stock Price Index (KOSPI), conducts research and development at the Innovation and Discovery Center (IDC) in Busan and manufacturing in Osong, completing a research-to-development-to-production value chain in South Korea.
However, the operating loss widened to $64.57 million from $48.02 million the previous year. The increase reflected continued selling, general and administrative expenses, including higher research and development costs and amortization expenses for intangible assets.
Impairment Charges Recognized All at Once Lead to Swing Into Loss
The direct cause of the swing into a loss was the large impairment charge. The company recognized an impairment loss of $11.52 million on intangible assets related to Tuznue and an $8.15 million impairment loss on assets under construction in its consolidated results. On a separate basis, it also recognized an additional $94.07 million impairment loss on investments in subsidiaries. As a result, the company swung sharply from net income of $2.97 million the previous year to a net loss of $84.77 million.
Industry analysts interpret the recognition of these impairment charges as a so-called “big bath” strategy, in which weak assets are written off from the books in advance. The aim, they say, is to substantially reduce additional accounting risks in the future by clearing out impaired assets at once and establish a foundation for improved results beginning in the next fiscal year.
Meanwhile, the company’s global commercialization footprint is expanding rapidly. On Sept. 18, it obtained marketing authorization for Tuznue in Trinidad and Tobago, a foothold for entry into Latin America and the Caribbean. Earlier, in August, it received good manufacturing practice (GMP) eligibility approval for its manufacturing facility from Brazil’s National Health Surveillance Agency (ANVISA), satisfying a key regulatory requirement for entering the Latin American market. Marketing authorization reviews are currently underway in four countries: Brazil, Colombia, Jamaica and Saudi Arabia.
Advanced-Market Expansion and New Drug Trials Key to Rebound
The biggest momentum driver in the second half of 2026 is the planned submission of marketing authorization applications for the Avastin biosimilar HD204, branded Vasfoda, to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). If the process proceeds successfully, entry into the large advanced-market oncology drug sector will come into view. During the same period, the company also plans to advance PBP1510, a targeted antibody drug candidate for pancreatic cancer, into a global phase 2a trial. If the candidate, which targets the pancreatic cancer treatment market with high unmet medical needs, produces meaningful clinical data, it could create an opportunity for a large-scale licensing deal with a multinational pharmaceutical company.
Industry observers say that while approval in the single market of Trinidad and Tobago is unlikely to drive overall results immediately, its significance lies in the company’s having passed an important regulatory gateway for entering large emerging markets such as Brazil and Saudi Arabia. Establishing local distribution networks through partnerships with global pharmaceutical companies and securing price competitiveness by leveraging its own CDMO operations are cited as key factors that will determine future success or failure. If royalty inflows from Tuznue sales in Latin America and Europe and CDMO orders translate into actual cash flow, profitability is expected to improve in earnest in fiscal 2027.

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