Correction and Replacement: Samsung Epis Holdings Announces First Quarter 2026 Financial Results
Samsung Epis Holdings has released its financial results for the first quarter of fiscal year 2026, presenting a picture of steady growth supported by the continued expansion of its biosimilar portfolio and strengthening global partnerships. The announcement also included a correction clarifying that the reported revenue and operating profit growth applies to the first quarter—not the fourth quarter—ensuring accurate interpretation of the company’s financial performance.
The updated financial disclosure highlights the company’s progress as it continues to build its presence in the global biopharmaceutical and biotechnology sectors. As the parent investment entity of Samsung Bioepis, Samsung Epis Holdings plays a key role in guiding strategic direction, capital allocation and long-term growth initiatives across its portfolio.
Commenting on the results, Kyung-Ah Kim, President and Chief Executive Officer, emphasized the organization’s strong operational momentum. She noted that Samsung Bioepis delivered solid performance during the quarter, driven by sustained demand across its biosimilar products. According to Kim, the company is continuing to reinforce its market position through new global collaborations and an expanding development pipeline.
She also highlighted a significant milestone for the organization: the 10th anniversary of its first biosimilar launch in Europe. This achievement reflects a decade of growth and innovation, during which Samsung Bioepis has evolved into a major player in the biosimilars space. Looking ahead, Kim reiterated the company’s commitment to building on this legacy while making targeted investments to support long-term value creation for shareholders.
Strong First Quarter Financial Performance
During the first quarter of 2026, Samsung Bioepis reported standalone revenue of KRW 454.9 billion and operating profit of KRW 144.0 billion. These figures represent a year-over-year increase of 14% in revenue (KRW 54.3 billion) and 13% in operating profit (KRW 16.1 billion), underscoring the company’s ability to sustain growth in a competitive and evolving market environment.
Notably, the company’s performance exceeded its internal guidance issued in January 2025 by more than 10%. This outperformance reflects stronger-than-anticipated demand across its product portfolio as well as effective execution of its commercial and operational strategies.
On a consolidated basis, Samsung Epis Holdings reported revenue of KRW 453.9 billion and operating profit of KRW 90.5 billion. These figures incorporate non-cash accounting adjustments, including the amortization of purchase price allocation (PPA)-related development costs. The consolidated results mark a significant improvement compared to the partial reporting period in November and December 2025, during which the company recorded revenue of KRW 251.7 billion and an operating loss of KRW 63.6 billion.
A comparison of recent quarterly performance further illustrates the company’s upward trajectory. Revenue has grown consistently from KRW 280.1 billion in the first quarter of 2024 to KRW 400.6 billion in the first quarter of 2025, and now to KRW 454.9 billion in the first quarter of 2026. Similarly, operating profit has increased from KRW 38.1 billion in 2024 to KRW 127.9 billion in 2025, reaching KRW 144.0 billion in 2026. These trends reflect both expanding market penetration and improved operational efficiency.
Key Business Developments
In addition to its financial performance, Samsung Bioepis reported several strategic developments that are expected to support future growth. One of the most notable updates is the company’s private label partnership with CVS Caremark, the pharmacy benefit management division of CVS Health. This agreement focuses on OSPOMYV™, a biosimilar referencing denosumab, a therapy widely used for conditions such as osteoporosis. The partnership is expected to enhance market access and broaden the product’s reach in the United States.
Another key highlight is the continued success of BENEPALI™ (etanercept), which remains a leading biosimilar product in Europe. As the company celebrates the 10th anniversary of its European launch, BENEPALI™ stands as a testament to Samsung Bioepis’s long-standing commitment to delivering high-quality, cost-effective biologic therapies. Its sustained market leadership underscores the company’s strong commercial capabilities and the growing acceptance of biosimilars among healthcare providers and patients.
In March 2026, Samsung Bioepis further strengthened its collaboration with Sandoz, expanding their partnership to include up to five additional biosimilar candidates. Among these is SB36, a biosimilar candidate referencing Entyvio (vedolizumab), which is used to treat inflammatory bowel diseases. This expanded agreement reflects the companies’ shared commitment to accelerating the development and commercialization of biosimilars across multiple markets.
Advancing Innovation Beyond Biosimilars
While biosimilars remain a core focus, Samsung Bioepis is also advancing its pipeline of novel therapies, particularly in the field of oncology. In March 2026, the company initiated a Phase 1 first-in-human clinical trial for SBE303, its first antibody-drug conjugate (ADC) candidate. ADCs are an emerging class of targeted cancer therapies that combine the specificity of antibodies with the potency of cytotoxic drugs.
The company also presented preclinical data for SBE303 at the American Association for Cancer Research Annual Meeting 2026 on April 20. The data demonstrated encouraging results in terms of efficacy, safety and tolerability, as well as potential synergy when used in combination with existing immuno-oncology treatments. These findings support further clinical development and highlight the company’s growing capabilities in innovative therapeutics.
In parallel, Samsung Bioepis is progressing its second ADC candidate, SBE313, which is currently in nonclinical development. This program is being conducted in collaboration with Phrontline Biopharma, further illustrating the company’s strategy of leveraging partnerships to accelerate innovation.
The first quarter results and accompanying business updates reflect a company that is successfully balancing near-term performance with long-term strategic investment. By continuing to expand its biosimilar portfolio while also advancing novel therapeutic platforms, Samsung Bioepis is positioning itself for sustained growth in an increasingly competitive global market.
At the same time, Samsung Epis Holdings remains focused on maintaining financial discipline and delivering value to shareholders. The company’s ability to exceed guidance, improve profitability and execute on key partnerships demonstrates strong operational resilience and strategic clarity.
As with any forward-looking financial disclosure, the company noted that its projections and expectations are subject to various uncertainties. These include fluctuations in global financial markets, changes in exchange rates and interest rates, and other external factors that may influence business performance.
While the company remains optimistic about its growth trajectory, it emphasized that actual results may differ from current expectations due to these variables. Nevertheless, the strong start to 2026 provides a solid foundation for continued progress throughout the year.
Overall, the updated first quarter 2026 financial results highlight a period of robust growth and strategic advancement for Samsung Epis Holdings and Samsung Bioepis. With strong financial performance, expanding partnerships and a deepening pipeline of both biosimilar and novel therapies, the organization is well-positioned to navigate the evolving biopharmaceutical landscape and deliver long-term value to stakeholders.
About Samsung Epis Holdings Co., Ltd.
As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: www.samsungepisholdings.com.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.
About Epis NexLab Co., Ltd.
Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases.
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