Samsung Epis Holdings Reports First Quarter 2026 Financial Results

(BUSINESS WIRE)--Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced its financial results for the first quarter of fiscal year 2026.

“Samsung Bioepis delivered solid growth this quarter driven by continued momentum across our biosimilar portfolio," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We are further strengthening our position through new global partnerships and continued portfolio expansion. As we mark the 10^th anniversary of the launch of our first biosimilar in Europe, we remain focused on building on our legacy while investing strategically to support long-term growth. We remain committed to delivering sustainable value for our shareholders.”

First Quarter 2026 Results

On a standalone basis, in the first quarter of 2026, Samsung Bioepis posted a revenue of KRW 454.9 billion with an operating profit of KRW 144.0 billion. Revenue and operating profit in the fourth quarter increased by 14% (KRW 54.3 billion) and 13% (KRW 16.1 billion) in year-over-year (YoY), respectively.

First quarter growth surpassed the January 2025 guidance by more than 10%, reflecting stronger-than-expected performance across the business.

Samsung Epis Holdings posted a consolidated revenue of KRW 453.9 billion and operating profit of KRW 90.5 billion. Non-cash accounting adjustments, including amortization of purchase price allocation (PPA)-related development costs, are reflected in consolidated revenue and operating profit, following a consolidated revenue of KRW 251.7 billion and operating loss of KRW 63.6 billion in November and December 2025.

Business Updates

• In October 2025, Samsung Bioepis entered into a private label partnership with CVS Caremark, the Pharmacy Benefit Manager (PBM) division of CVS Health, for OSPOMYV™ (denosumab-dssb), a biosimilar to Prolia¹.
• BENEPALI™ (etanercept), Samsung Bioepis’ first biosimilar in Europe, continues to maintain its leadership position in the market as it celebrates its 10^th anniversary in Europe.
• In March, Samsung Bioepis expanded its development and commercialization partnership with Sandoz, on up to five biosimilar candidates including SB36, a biosimilar candidate referencing Entyvio (vedolizumab), in multiple markets.
• Also in March, a Phase 1 first-in-human clinical trial for Samsung Bioepis’s first novel antibody-drug conjugate (ADC) candidate, SBE303, has begun. Following the announcement, the company also presented a poster presentation of its nonclinical data at the American Association for Cancer Research (AACR) 2026 on April 20^th which demonstrates its encouraging efficacy, safety, tolerability and a promising ability to work in combination with existing immuno-oncology therapies.
• Samsung Bioepis’s second novel ADC candidate, SBE313, is currently in nonclinical development in collaboration with Phrontline Biopharma.

Disclaimer

This document contains ‘forward-looking statements’ regarding future expectations, projections, plans, and anticipation. ‘Forward-looking statements’ are matters that pertain to the Company’s future business and financial performance, and are subject to uncertainties such as trends in domestic and international financial markets, including but not limited to fluctuations in exchange rates and/or interest rates.

‘Forward-looking statements,’ by their nature, addresses matters that may be uncertain; actual results may be materially different from those expressed in this document.

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. For more information about Epis NexLab, please visit: www.samsungepisholdings.com.

Reference
¹ Prolia is a registered trademark of Amgen Inc.

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