Celltrion announced on the 3rd that on a consolidated basis for the second quarter of this year, it posted provisional results of KRW 1.3 trillion in revenue and KRW 430 billion in operating profit. Compared with the same period last year, revenue increased 35.2% and operating profit 77.3%, reflecting a significant improvement in overall profitability. As a result, the operating margin jumped from 25% to around 33%. On a quarterly basis, this is the company’s highest performance to date.

The industry evaluated that the results, which have completely shaken off merger-related issues at Celltrion, exceeded market expectations. Following the first quarter, Celltrion also delivered an earnings surprise in the second quarter. Celltrion stated, “These results represent not just a simple increase in sales, but qualitative growth, as the share of new high-margin products has expanded while the cost structure has improved at the same time.” It was also noted that the company exceeded its previously disclosed second-quarter operating profit target of KRW 400 billion in its early-year announcement on future business and management plans, further enhancing confidence in management and the company’s ability to execute its annual business plan.

Considering the seasonal pattern in the biosimilar industry, where revenue tends to increase in the second half of the year due to concentrated supply for major national tenders and year-end inventory build-up, growth is expected to accelerate further in the latter half. Expectations are also rising that the company may surpass its full-year performance targets.

● Shift to growth driven by high-margin products… “Profitability improvement in full swing”

Celltrion explained that the latest performance reflects a portfolio reshaped toward high value-added products, as new high-margin products have grown rapidly on the back of solid sales of existing flagship products. It said that new products such as Remsima SC (Zymfentra in the US, infliximab), Yuflyma (adalimumab), and Steqima (ustekinumab) are maintaining strong growth in major global markets, and that these new products now account for more than 60% of total revenue.

In particular, Zymfentra is reportedly continuing to break its own record for prescriptions in the US. Steqima is also said to have rapidly expanded its market share in the US and entered the leading group. In addition, Celltrion emphasized that Aptozma (tocilizumab) and Stovocllo-Osenvelt (denosumab) are gaining traction in the market and establishing themselves as new growth pillars. In Europe, Omlyclo (omalizumab) is attracting attention. As a first-mover product, it continues to benefit from early market entry. Vegzelma (bevacizumab), despite entering the market as a latecomer, has achieved the top market share in key countries. Analysts say such portfolio strengthening is creating positive synergies. Other products including Aptozma, Yuflyma, and Stovocllo-Osenvelt are also entering a phase of accelerating sales growth and are expected to support future performance expansion.

Celltrion said that most one-off costs related to the merger have now been resolved. It also stressed that cost competitiveness continues to improve, driven by the clearance of high-cost inventories, the end of development cost amortization, and higher production yields. A Celltrion representative explained, “The improvement in profitability is a structural change based on a better product mix and enhanced production efficiency, rather than a one-off effect, so we expect stable profit growth to continue going forward.” ● Similars, new drugs, and production capacity strengthened in parallel… “Expanding the foundation for mid- to long-term growth”

Celltrion stated that it is also accelerating efforts to secure future growth engines. Its new autoimmune disease treatment Cosentyx (secukinumab) biosimilar CT-P55 is undergoing regulatory review in Korea, North America, and other key markets. Herzuma SC, a subcutaneous formulation of Herzuma (trastuzumab), is also sequentially pursuing marketing approval in major global countries. In addition, follow-up biosimilars to Keytruda (pembrolizumab) and Darzalex (daratumumab) are progressing smoothly. Celltrion’s strategy is to build a biosimilar portfolio of 18 products by 2030 and a total of 41 products by 2038.

In new drug development, antibody-drug conjugate (ADC)-based oncology drug candidates CT-P70 and CT-P71 have been granted Fast Track designation in the United States, accelerating their development. Celltrion aims to secure a portfolio of 20 new drugs by next year.

The company is also strengthening manufacturing capacity to support portfolio expansion. In Korea, it is pursuing the expansion of its 4th and 5th plants with a combined capacity of 180,000 liters, in addition to its existing facilities of approximately 250,000 liters. At its Branchburg plant in New Jersey, USA, Celltrion has decided to add 75,000 liters of capacity. Through this, it plans to secure a total production capacity of 141,000 liters in the United States, thereby enhancing both the stability of its global supply chain and its responsiveness to the US market. In particular, the expansion of US production sites is expected to be a positive factor for increasing mid- to long-term corporate value, as it structurally mitigates tariff and supply chain risks while also providing a foundation for expanding its global contract manufacturing (CMO) business.

A Celltrion representative said, “These results show that our strategies to expand new products and improve profitability are now clearly bearing fruit,” adding, “We will strengthen a sustainable growth base by simultaneously pursuing the expansion of our product portfolio, enhancement of production capabilities, and new drug development.” The representative continued, “In the second half, expanded tenders in major countries and the growth of new products will be fully reflected, and we will aim to surpass first-half results and steadily build the competitiveness needed to grow into a global big pharma company.”

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