Celltrion has reported its highest-ever quarterly performance in the first quarter of this year, raising expectations for continued growth in the second quarter. Although the biosimilar industry typically experiences a slowdown in the first quarter, Celltrion demonstrated improved performance driven by the rapid market acceptance of high-revenue new products and stable prescription growth for existing products.
Analysts suggest that the strong performance in the first quarter could serve as a starting point for annual growth, considering that major European tenders are concentrated in the second and third quarters, with initial supply volumes expected to be reflected in the second half of the year. Additionally, the operational effects of the Branchburg plant in the U.S. are expected to further enhance growth prospects in the second quarter.
◆ Q1 Performance Driven by Existing and New Product Growth… European Market Prescription Expansion Continues
In the first quarter, Celltrion recorded consolidated sales of 1.145 trillion won and an operating profit of 321.9 billion won, marking increases of 36% and 115.5%, respectively, compared to the same period last year. The operating profit margin improved to 28.1%. Excluding temporary impacts from regular maintenance of U.S. production facilities, the actual operating profit margin is expected to reach the 30% range.
The growth in performance was driven by an expansion in prescriptions in the European market. Celltrion's flagship autoimmune disease treatment, the Remsima product line, achieved a combined market share of 70% in Europe as of the fourth quarter of 2025. Notably, Remsima SC has absorbed the demand for transitioning patients from intravenous (IV) prescriptions, continuing to expand prescriptions in major countries such as Germany (50%) and France (36%).
New products have also established a foothold in the market. Omliclue, a treatment for chronic spontaneous urticaria and allergic asthma launched in Europe in September last year, secured significant market shares shortly after its release, achieving 98% in Denmark, 80% in Spain, and 70% in the Netherlands within four months.
The autoimmune disease treatment Aptozma, which was sequentially launched in major European countries from late last year to January this year, has also seen an expansion in prescriptions within the European market. The introduction of subsequent biosimilar products has rapidly reshaped the product portfolio to focus on high-revenue items.
Celltrion reported that five new biosimilars launched last year generated a combined revenue of 581.2 billion won in the first quarter, accounting for about 60% of total product sales. This product line's revenue increased by 67% compared to the same period last year, indicating a shift into a sales expansion phase.
As initial supply volumes from European tenders will be reflected in the second half of the year, the trend of expanding sales for new products is expected to become more pronounced.
◆ Branchburg Plant Operations Enhance Production Capacity
Celltrion is expanding its global production infrastructure and strengthening new business initiatives through its Branchburg plant in New Jersey. The facility, with a capacity of 66,000 liters, has resumed normal operations following regular maintenance, and contract manufacturing (CMO) and validation of its own products are expected to begin contributing to revenue in the second quarter.
While the initial contribution to short-term profits from the Branchburg plant may be limited due to startup costs, it is viewed as a strategic base for enhancing supply responsiveness and mitigating tariff risks through local production. Celltrion plans to expand its production capacity from the current 316,000 liters to 571,000 liters through the expansion of its Songdo plants 4 and 5 and additional expansions at Branchburg.
The CMO business is also a new growth pillar. Celltrion has surpassed 1 trillion won in cumulative orders based on contracts with global pharmaceutical companies.
The Branchburg plant is expected to serve as a key infrastructure for expanding its own product production and contract development and manufacturing (CDMO) business. This aligns with the global sales expansion of high-revenue new products and is anticipated to support long-term cost competitiveness and profitability improvements.
◆ Analysts Predict Growth from New Products and Profitability Improvements
Analysts are viewing Celltrion's performance trends positively. Major securities firms have assessed that the company's first-quarter results reflect a significant change in its performance structure, driven by revenue growth from high-revenue new products, synergies in European sales, and cost improvement effects.
Daishin Securities noted that Celltrion has entered a phase of profitability improvement by eliminating one-time costs following its merger and leveraging its own production and direct sales systems. With improvements in the global biosimilar product mix and growth from new products, the EBITDA margin is expected to rise to the high 30% range, and the benefits of an expanded product portfolio will also begin to materialize.
Currently, the biosimilar product portfolio consists of 11 items, with plans to expand to 18 by 2030 and 41 by 2038. As fixed cost leverage increases, profitability improvements are expected to continue alongside the growing share of new high-revenue products.
Industry experts believe that the combination of stable market dominance from existing flagship products, growth from new products, and the effects of expanded production infrastructure will further strengthen Celltrion's leading position in the global biosimilar market. In particular, the operationalization of the Branchburg plant and the expansion of high-revenue product sales are expected to sustain growth momentum beyond the second quarter.
* This article has been translated by AI.
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