Celltrion 2Q Sales 524 Billion KRW, Operating Profit Down 10%... "Biosimilars, Continuous Growth"

CELLTRION recorded second-quarter earnings that decreased compared to the same period last year. However, the company emphasized that sales and profit margins in its core biosimilar business improved.

Incheon Songdo Celltrion Plant 2 exterior./Incheon=Photo by Hyunmin Kim kimhyun81@

On the 14th, CELLTRION announced through its semi-annual report that its consolidated operating results for the second quarter of this year were KRW 523.97843 billion in sales and KRW 182.99394 billion in operating profit. The operating profit margin was 34.9%. Compared to the same period last year, sales decreased by 12.1% and operating profit decreased by 10.1%.

On a cumulative basis for the first half of the year, the company posted sales of KRW 1.1215 trillion and operating profit of KRW 365.42888 billion. Compared to the same period last year, sales decreased by 0.5%, but operating profit increased by 9.8%.

The company explained that for the second quarter, "Overall sales and operating profit decreased compared to the same period last year due to the adjustment of the timing of international procurement bids in the chemical division and a decrease in other sales such as service revenue," but added, "Sales of the core biosimilar business (biopharmaceutical generics) increased by 10.4% due to the supply of new follow-up pipelines, which helped improve the overall operating profit margin." In particular, regarding operating profit, the company added, "Future profitability expansion is expected through high-margin products such as 'Uplyma' and 'Remsima SC.'"

Celltrion's Humira biosimilar 'Yuflyma'
[Photo by Celltrion Healthcare]

The core business of CELLTRION, the antibody biosimilar business, is maintaining stable market shares in major global markets such as Europe and the United States with its key product lines. According to IQVIA, a pharmaceutical market research firm, and CELLTRION Healthcare, which handles overseas sales of CELLTRION products, in the first quarter of this year, Remsima (active ingredient infliximab) recorded a market share of 61.7%, Truxima (rituximab) 22.1%, and Herzuma (trastuzumab) 19.2% in the European market. In particular, Remsima and Truxima are said to have solid market shares exceeding those of the original products (Remicade and MabThera). In the U.S. market, as of the first quarter of this year, Remsima (sold as 'Inflectra' in the U.S.) holds a 30.2% market share, and Truxima holds 30.5%.

Among these active ingredients, Remsima SC, which succeeded in formulation improvement to a subcutaneous injection (SC) form and is considered CELLTRION's next-generation core product, continued its growth trend by recording a 17.0% market share in the five major European countries (EU5) as of the first quarter. Especially, the combined market share with the existing intravenous (IV) formulation of Remsima is 68.5%, showing a strong synergy effect. A CELLTRION official expressed optimism, stating, "The upward trend of Remsima SC in the European market is expected to have a positive impact on its entry into the U.S. market in the future." Currently, although Remsima SC was developed as a biosimilar, the U.S. Food and Drug Administration (FDA), noting the formulation improvement, has recommended proceeding with new drug approval procedures, and the approval process as a new drug is currently underway. The approval decision is expected in October.

Development of follow-up biosimilar portfolios is also ongoing. CELLTRION has announced the '3rd Wave' plan to expand its biosimilar portfolio to 22 products by 2030. Recently, biosimilars for Xolair (CT-P39), Stelara (CT-P43), and Eylea (CT-P42) are undergoing approval processes in major global countries, and biosimilars for Prolia (CT-P41) and Actemra (CT-P47) are expected to complete Phase 3 clinical trials within this year and proceed with regulatory approval applications in various countries.

The company is also focusing on securing next-generation growth engines through expanding strategic partnerships with innovative new drug and platform holders. In the U.S., CELLTRION is jointly developing an oral formulation of 'adalimumab' with Lani Therapeutics, which owns proprietary oral platform technology, and domestically, it is strengthening big data analysis capabilities through joint development of genomic biomarkers with Vasgen Bio. Additionally, CELLTRION plans to continue expanding strategic partnerships and investments with various companies that possess platforms and pipelines in new modality fields such as antibody-drug conjugates (ADC), bispecific antibodies, antibody drugs, and microbiomes.

A CELLTRION official stated, "While major biosimilar products continue stable growth in the global market, steady growth is expected as next-generation products such as Uplyma and Remsima SC expand their market presence and shares. We will also strengthen our business competitiveness by smoothly progressing global clinical trials and approvals for follow-up new biosimilar pipelines and strive to advance our business portfolio to become a new drug development company."

This content was produced with the assistance of AI translation services.