Samsung Epis Holdings (KRX: 0126Z0), a holding company dedicated to innovations in biopharmaceuticals and biotechnology, today announced its financial results for the third quarter and first nine months of fiscal year 2026.
“Our performance in the first nine months underscores the continued commercial resilience and underlying earnings power of our biosimilar portfolio, achieving nearly our entire prior-year operating profit in just three quarters,” said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “Underpinned by steady organic product sales growth across major markets including the US and Europe, we are accelerating strategic partnerships, advancing pivotal regulatory milestones for next-generation biosimilars, and expanding our novel therapeutic pipeline in antibody-drug conjugates and metabolic disorders to ensure sustainable long-term value creation.”
Third Quarter and Nine-Month 2026 Results – Samsung Bioepis
Samsung Bioepis, a 100% owned subsidiary of Samsung Epis Holdings, recorded cumulative nine-month revenue of KRW 1.29 trillion and an operating profit of KRW 363.2 billion, achieving 97% of the total operating profit generated in the full fiscal year 2025 (KRW 375.9 billion) within just three quarters.
For the third quarter of 2026, Samsung Bioepis recorded revenue of KRW 442.2 billion and an operating profit of KRW 132.6 billion, representing a year-over-year (YoY) increase of KRW 1.2 billion (+0.3%) and KRW 3.6 billion (+2.8%), respectively. Excluding milestone revenues, commercial product sales reached KRW 416.5 billion (up 4.1% YoY) and product-level operating profit reached KRW 106.9 billion (up 21.3% YoY). Growth in commercial performance was driven primarily by continued uptake of EPYSQLI® (eculizumab-aagh) in the United States (US) following its launch in April 2025, alongside expanding sales of PYZCHIVA™ (ustekinumab) in Europe.
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[Samsung Bioepis Earnings, KRW billion] |
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|
|
Q3’26 |
Q3’25 |
YoY Change |
QoQ1 Change |
|
Revenue |
442.2 |
441.0 |
1.2 (+0.3%) |
50.0 (+12.7%) |
|
Excluding Milestones |
416.5 |
400.1 |
16.4 (+4.1%) |
24.3 (+6.2%) |
|
Operating Profit |
132.6 |
129.0 |
3.6 (+2.8%) |
46.0 (+53.1%) |
|
Excluding Milestones |
106.9 |
88.1 |
18.8 (+21.3%) |
20.3 (+23.4%) |
Business Updates
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Commercial Footprint & Biosimilar Pipeline Expansion: Samsung Bioepis currently commercializes 11 biosimilar products across global markets and is advancing a robust pipeline of nine subsequent biosimilar candidates targeting blockbuster biologic therapies approaching patent expiration.
- Following the announcement of positive preliminary Phase 1 and Phase 3 data demonstrating therapeutic equivalence of SB27 to reference pembrolizumab in June 2026, Samsung Bioepis became the first company in Korea to apply to the Ministry of Food and Drug Safety (MFDS) for marketing authorization of SB27, a proposed biosimilar to Keytruda2 (pembrolizumab), in August 2026.
- In October 2026, Samsung Bioepis entered into a strategic development and commercialization agreement with Teva for two novel biosimilar candidates referencing Fasenra3 (benralizumab) and Ilaris4 (canakinumab), securing commercialization pathways across key global territories, including the US and Europe.
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Novel Therapeutics R&D Advancement (ADCs & Metabolic Diseases): Samsung Bioepis continues to accelerate proprietary novel biologic development across high-potential disease indications, comprising two novel ADCs and one long-acting anti-obesity therapeutic.
- SBE303, the company’s first proprietary clinical-stage ADC candidate, is currently undergoing a global Phase 1 clinical trial in advanced solid tumors initiated in March 2026. In October 2026, SBE303 was recently granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to facilitate and expedite development for patients with serious unmet medical needs.
- Leveraging open innovation with domestic and international partners, the company is also progressing preclinical development for SBE313, a next-generation ADC candidate, and SBE501, an innovative semaglutide-based long-acting injectable (LAI) candidate.
Third Quarter and Nine-Month 2026 Results – Samsung Epis Holdings
Samsung Epis Holdings recorded consolidated revenue of KRW 441.9 billion and an operating profit of KRW 105.0 billion for the third quarter of 2026, maintaining robust financial soundness while incorporating non-cash accounting adjustments, including the amortization of intangible assets and development costs related to purchase price allocation (PPA).
Under its holding company framework, Samsung Epis Holdings continues to foster core operating growth through Samsung Bioepis while exploring multi-faceted business opportunities through its biotechnology platform subsidiary, Epis NexLab, and its global R&D hub, Samsung Bioepis (China) Co., Ltd.
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 a holding 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. As a wholly owned subsidiary of Samsung Epis Holdings, 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.
| 1 Quarter-on-Quarter | |
| 2 Keytruda is a trademark of Merck Sharp & Dohme LLC. | |
| 3 Fasenra is a trademark of AstraZeneca AB. | |
| 4 Ilaris is a trademark of Novartis AG. | |
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