Celltrion Reports Operating Profit of 753.9 Billion KRW Last Year, Up 5.9% Year-on-Year

Achieved Record High Sales, Operating Profit, and Pre-Tax Profit
Strong Sales Driven by Leading Biosimilars and Increased Market Share in the US
Commercialization of Follow-up Pipelines and Strengthening of COVID-19 Solutions
Continued Growth Expected with Expansion of RemsimaSC Market

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 16th that its consolidated operating profit for last year reached 753.9 billion KRW, a 5.9% increase compared to the previous year. Sales rose 2.3% to 1.8908 trillion KRW, and annual pre-tax profit also increased by 21.6% to 791.5 billion KRW. These figures represent the highest-ever sales and operating profit.

Looking at the fourth quarter of last year alone, sales reached 601.1 billion KRW, achieving the highest quarterly performance, and operating profit was 219 billion KRW. Compared to the same period last year, sales increased by 20.5% and operating profit by 33.0%.

Celltrion explained that it achieved favorable results due to strong sales of biosimilar products, mainly in the U.S. market, along with increased sales of COVID-19 related therapeutics and diagnostic kits. For its main antibody biosimilar product lineup, stable market shares were recorded in the European market as of the third quarter of last year: Remsima 54%, Truxima 34%, and Herzuma 13%.

In particular, the increase in market share of the main antibody biosimilar products in the U.S. market last year was notable and contributed to securing sales. As of the fourth quarter of last year, the U.S. market shares were 22.6% for Remsima (sold as Inflectra in the U.S.) and 25.4% for Truxima. These figures represent increases of 10.8% and 5.6%, respectively, compared to the previous year.

Celltrion plans to achieve sustainable growth this year by focusing on ▲expanding its main biopharmaceutical portfolio ▲strengthening its COVID-19 solution business ▲expanding the market share of RemsimaSC. Among the total of 11 biosimilar products currently held (5 commercialized, 6 under development), Celltrion plans to expand the launch regions or newly launch at least 5 products by next year to cultivate new growth engines.

In February last year, Celltrion received European sales approval for the high-concentration Humira biosimilar ‘Uplima (CT-P17),’ and in December, it obtained sales authorization from Health Canada, securing a foothold for entry into the North American market. Additionally, the colorectal cancer treatment CT-P16 (Avastin biosimilar) applied for approval in Europe last October following approvals in Korea and the U.S., and plans to promptly introduce the product to the market once approval is granted.

As for the follow-up pipeline, global Phase 3 clinical trials are underway for CT-P39 (Xolair biosimilar), CT-P41 (Prolia biosimilar), CT-P42 (Eylea biosimilar), and CT-P43 (Stelara biosimilar). In the fourth quarter of last year, Phase 1 clinical trials for the rheumatoid arthritis treatment Actemra biosimilar CT-P47 were initiated.

Furthermore, Celltrion recently confirmed the safety of its inhaled antibody treatment for COVID-19 in a Phase 1 clinical trial in Australia and has officially begun global clinical trials for the inhaled cocktail COVID-19 antibody treatment. With the safety of the inhaled antibody treatment confirmed, Celltrion is accelerating the development of the inhaled cocktail antibody treatment by adding the COVID-19 therapeutic candidate ‘CT-P63,’ whose safety was confirmed in the early Phase 1 trial, earlier this year. On the 3rd, it completed the submission of clinical trial applications (IND) for Phase 3 clinical trials of the inhaled cocktail antibody treatment in three countries: Bosnia, Serbia, and North Macedonia.

Celltrion also expects penetration of RemsimaSC in the autoimmune disease treatment market. RemsimaSC, a subcutaneous injection formulation, significantly improves treatment convenience by allowing patients to self-administer without hospital visits. In particular, a 54-week switching clinical trial conducted on patients with inflammatory bowel disease (IBD) showed better results in blood concentration and antibody response (ADA) compared to the intravenous (IV) formulation, raising expectations for expanded dual formulation prescriptions combining IV and SC formulations.

A Celltrion official stated, “We were able to maintain favorable results last year through expanded sales of our main antibody biosimilar and COVID-19 solution product lines,” adding, “This year, we will continue to grow sustainably as a global pharmaceutical and bio company by discovering new growth engines and focusing our capabilities.”

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