Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results

Core Viewpoint - Samsung Epis Holdings reported strong year-to-date sales growth driven by its biosimilars portfolio following its spin-off, with a focus on sustainable growth and long-term value creation for shareholders [1][3]. Financial Performance - In Q4 2025, Samsung Bioepis achieved consolidated revenue of KRW 429.4 billion, with an operating profit of KRW 29.2 billion, marking a year-over-year increase of 23% in revenue and 14% in operating profit [2]. - For the full year 2025, revenue reached KRW 1.672 trillion (+9%), while operating profit was KRW 375.9 billion (-14%). Excluding milestone revenue, sales revenue increased by 28% to KRW 1.626 trillion, and operating profit surged by 101% to KRW 330.8 billion [3]. Product Development and Launches - Samsung Bioepis launched EPYSQLI (SB12), a biosimilar to Soliris, in the US in April 2025, enhancing access for patients with rare diseases [4]. - OBODENCE (SB16) and XBRYK (SB16), biosimilars to Prolia, received FDA and EC approval in February 2025, with launches in Europe occurring in December 2025 and January 2026, respectively [4]. - As of January 2026, Samsung Bioepis will directly commercialize four products in Europe, including EPYSQLI, OBODENCE, XBRYK, and BYOOVIZ [5]. Future Outlook - Samsung Epis Holdings aims to increase global biosimilar sales by over 10% year-over-year and plans to expand its portfolio to 20 biosimilars by 2030 [6]. - The company is also developing novel therapeutics, with plans to initiate clinical studies for SBE303, its first antibody-drug conjugate targeting Nectin-4, in patients with advanced solid tumors [6]. Subsidiary Developments - Epis NexLab, a new subsidiary under Samsung Epis Holdings, is focused on developing a peptide-based drug delivery platform [7].