[Edaily Reporter Hong Ju-yeon ] Celltrion(068270)Analysts note that as the company reduces its reliance on “Remsima” and expands its product portfolio with high-margin products, revenue diversification and profitability growth are gaining momentum. New products, such as the autoimmune disease treatment “Uplima” (active ingredient: adalimumab) and the allergy treatment “Omriclo” (active ingredient: omalizumab), now account for more than 60% of total revenue. The five new products include Stekima (active ingredient: ustekinumab), Stovoclo & Osenvelt (active ingredient: denosumab), Aptozma (active ingredient: tocilizumab), Omriclo, and Idenzelt (active ingredient: aflibercept).

A clear virtuous cycle is evident, in which the market position established by existing product lines—such as the blood cancer treatment “Truxima” (active ingredient: rituximab), which has held the top market share in the U.S. for four consecutive months—serves as a foundation for the successful launch of subsequent products. With the “patent cliff”—a period marked by the successive expiration of patents for global blockbuster drugs—looming, analysts predict that the company’s vertically integrated structure, which encompasses everything from R&D to direct sales, will be reevaluated.

Q2 Operating Profit Up 77% to Record High… New Products Account for Over 60% of Sales

According to Celltrion, preliminary consolidated results for

the second quarter

showed revenue of 1.3 trillion won and operating profit of 430 billion won, representing year-over-year increases of 35.2% and 77.3%, respectively, and setting a new record for the second quarter. The operating profit margin improved significantly from 25% last year to approximately 33%, and the company exceeded its Q2 operating profit target (400 billion won) set at the beginning of the year. This reflects the company’s success in achieving both revenue growth and improved profitability.

The growth was driven by an increased share of high-margin new product lines. New products—including Remsima SC (U.S. product name: Zimpentra), Uplima, and Stekima (active ingredient: ustekinumab)—accounted for over 60% of total second-quarter revenue. This represents an increase of nearly 10 percentage points (p) from the 53% recorded in the second quarter of last year. Compared to existing flagship products such as Remsima, Truxima, and Herzuma, these products face less market competition and have a higher proportion of direct sales, resulting in a significant contribution to profitability. Additionally, factors such as the resolution of one-time costs following the merger, the complete clearance of high-cost inventory, the conclusion of R&D expense amortization, and improved production yield were all reflected simultaneously. The company views this not as a one-time effect but as a structural change based on an improved product mix and enhanced production efficiency.

The generational shift has been evident since the beginning of the year. First-quarter sales of new products surged 67% year-over-year to 581.2 billion won, pushing the share of biopharmaceutical sales past 60% for the first time, while total quarterly biosimilar sales rose 27% to 974.2 billion won. In particular, led by “Omriclo,” the Zolair biosimilar launched as a first-mover with no competing products, the combined first-quarter sales of five subsequent new products reached 211.3 billion won—approximately a tenfold increase compared to the same period last year. Despite the first quarter typically being considered the off-season for pharmaceuticals, revenue grew by 16% compared to the previous quarter. The company has presented an annual revenue plan for this year aimed at reducing the share of existing products to approximately 30% and expanding the share of highly profitable new products to around 70%.

Strong performance continues across individual products. Zimpentra continues to set new all-time prescription records in the U.S., while the Stelara biosimilar “Stekima” has rapidly expanded its market share in the U.S. to join the leading group and has also obtained approval for its autoinjector (AI) formulation in Canada. The Prolia biosimilars “Stovoclo” and “Osenvelt” have been listed as preferred drugs by three of the top five U.S. pharmacy benefit managers (PBMs), securing reimbursement coverage of over 60%. Together with the Actemra biosimilar “Aptozma,” they have successfully established themselves in the market and are emerging as key growth drivers. In Europe, Omriclo continues to capitalize on its first-mover advantage. Despite being a late entrant, Begzelma maintains the top market share in key countries. The Eylea biosimilar “Idenzelt” has successfully won a major tender in the UK.

Truxima Tops U.S. Rankings for 4 Consecutive Months… “Virtuous Cycle” Between New and Existing Products

The existing

product

portfolio is solidifying its leading position in

the United States

, the world’s largest pharmaceutical market. According to pharmaceutical market research firm IQVIA, Truxima recorded a 38.6% market share in the U.S. last May, achieving the No. 1 spot in prescriptions for four consecutive months since February. Compared to February, when it first claimed the top spot, Truxima increased its market share by 2.8 percentage points, further widening the gap with competing products, including the originator drug. Truxima is the first Korean biosimilar to claim the top market share position in the U.S. Earlier this month, it became the first rituximab biosimilar to receive “interchangeability” status from the U.S. Food and Drug Administration (FDA), allowing it to be substituted for the originator drug. This is expected to accelerate its penetration into the 20% market share currently held by the originator.

Other product lines are also performing well. “Inflectra” (the U.S. brand name for Remsima), a treatment for autoimmune diseases, maintained its position as the top prescriber with a 30.4% market share during the same period, while Stekima (13.3%), Begzelma (10.6%), and Uplima (8.1%) also continued to show steady growth. The success achieved by existing products is expected to carry over to upcoming products. Celltrion’s U.S. subsidiary plans to launch the subcutaneous (SC) formulation of “Aptozma” and “Omriclo” in the second half of this year. The company also plans to leverage the extensive PBM network it has built through sales of its autoimmune disease product portfolio to facilitate the early market penetration of these new products. With the second half of the year being the peak season—driven by tender volumes and year-end inventory demand—and the addition of initial shipments of products scheduled for launch in the U.S., growth is expected to accelerate further.
'Vertical

Integration' Ahead of the Patent Cliff… Responding with 41 Biosimilars and 20 New Drugs

The biosimilar market is entering a second phase of structural growth. This is because the patents for global blockbuster drugs such as Xolair, Eylea, Keytruda, Opdivo, and Stelara will expire in succession between 2026 and 2030. Competition is also expected to intensify as a result. Celltrion has secured control over costs and quality through a vertically integrated structure that internalizes the entire process—from R&D to clinical trials, approval, production, and direct sales. Another strength is the company’s track record of success with first-mover products, starting with Remsima in 2013, which has allowed it to accumulate expertise in obtaining approvals from global regulatory and supervisory agencies and in commercialization.

The regulatory environment is also becoming more favorable. Following Europe’s de facto exemption of biosimilars from Phase 3 clinical trials, the U.S. also passed legislation last month to ease related regulations. This measure, which abolishes the “interchangeable” designation that previously required additional clinical trials, reduces the burden of approval and follows the March policy to omit or simplify pharmacokinetic (PK) evaluations. Kim Seung-min, an analyst at MIRAE ASSET SECURITIES, noted, “Even amid intensifying biosimilar competition, players with clinical analysis capabilities and manufacturing competitiveness based on their experience developing existing biosimilars stand to benefit.” He added, “While sales of existing biosimilars are expected to decline, growth in high-margin new biosimilars is robust, and Zimpentra’s growth in the U.S. could exceed expectations.”

The company is also expanding its pipeline and strengthening its production capabilities. The Cosentix biosimilar “CT-P55” is undergoing the approval process in South Korea and North America, and “Herzuma subcutaneous injection (SC)” is also seeking approval in major countries sequentially. Through follow-on development of products such as Keytruda and Darzalex, the company aims to establish a portfolio of 18 biosimilars by 2030 and a total of 41 by 2038. In the new drug sector, the antibody-drug conjugates (ADCs) “CT-P70” and “CT-P71” have been designated for the FDA’s Fast Track program, and the company plans to submit applications for “CT-P72” and “CT-P73” within the year, aiming to secure a total portfolio of 20 new drugs by next year. On the production front, the company plans to secure a total production capacity of 141,000 liters in the U.S. through its domestic Plants 4 and 5 (180,000 liters) and the expansion of its Branchburg, New Jersey facility (75,000 liters). This strategy aims to mitigate tariff and supply chain risks while establishing a global contract manufacturing organization (CMO) base.

Regarding its second-quarter results, Celltrion stated that the figures demonstrate that its strategies for expanding new products and improving profitability have begun to yield tangible results. The company added that, as it expects to see increased participation in tenders in major countries and the full impact of new product growth in the second half of the year, it intends to maintain performance that surpasses that of the first half and continue to enhance its competitiveness to leap forward as a global big pharma.