Celltrion said on the 5th that its operating profit under consolidation last year was 1.1685 trillion won, up 137.5% from a year earlier. Revenue for the same period rose 17% to 4.1625 trillion won, the highest ever.
The company cited the rapid expansion of high-margin new product sales, along with stable growth of existing products, as the key drivers of improved results.
While existing flagship products such as Remsima, Truxima and Herzuma maintained steady momentum, new products including Remsima SC, Yuflyma, Vegzelma, Zympentra, Steqeyma, OMLYCLO, and Stoboclo·Osenbelt gained a foothold in the market, pushing global biopharmaceutical revenue last year to 3.8638 trillion won, up 24% from a year earlier. Of that, new products accounted for 54%, surpassing half.
By product, Remsima held a 59% share in Europe and 30% in the United States (sold as Inflectra), maintaining stable performance. Recently, following the intravenous (IV) formulation, the company launched a liquid formulation that halves preparation time and improves storage convenience, which is expected to boost prescriptions.
Truxima posted market shares in the 30% range in both the United States and Europe, growing 17.1% from a year earlier. Herzuma maintained the No. 1 share in Europe and grew 10.1% year over year in Japan with a share reaching 75%. Yuflyma ranked No. 1 in Europe and grew 44% in the United States as prescriptions increased. Vegzelma also maintained the No. 1 share in Europe.
Five new products (Steqeyma, Stoboclo·Osenbelt, OMLYCLO, Aptozma, Eydenzelt) surpassed 300 billion won in annual revenue, even though they were launched in the second half of last year or were in launch-preparation stages in some regions. The company said listings as preferred drugs by major U.S. pharmacy benefit managers (PBMs) and country-by-country tender wins in Europe drove the results.
Profitability improved along with top-line growth. Celltrion's cost of sales ratio in the fourth quarter of last year was 35.8%, about 3 percentage points lower than the third quarter (39%). The cost ratio, which had reached about 63% in the fourth quarter of 2023 right after the merger, improved significantly due to the clearance of high-cost inventory and the completion of development cost amortization, effectively dissipating the merger impact.
Celltrion set this year's revenue target at 5.3 trillion won. It plans to reliably supply its 11 biosimilar products currently available in global markets based on domestic and overseas production facilities and a direct sales network, and to strengthen market dominance with country-specific strategies. In particular, it aims for solid growth by reducing the proportion of high-cost products and pursuing a tender strategy centered on new, higher-margin products. Accordingly, it expects the share of revenue from new products to expand to around 70% this year.
At the Branchburg, New Jersey, U.S., manufacturing site, where the acquisition was completed at the end of last year, the company plans to supply biopharmaceuticals worth about 678.7 billion won over three years through 2029 to Eli Lilly and Company. As a result, contract manufacturing organization (CMO) revenue is expected to begin in earnest this year. The company plans to use the site as a U.S. supply base for its own products and as a core hub for its global contract development and manufacturing organization (CDMO) business by expanding production capacity to up to 132,000 liters.
Celltrion is also accelerating new drug development along with biosimilar expansion. The biosimilar portfolio, currently at 11, is set to expand to 41 by 2038, which it said would push the addressable global market to more than 400 trillion won.
In autoimmune disease treatments, a phase 1 trial of the Taltz biosimilar (CT-P52) is underway, with submissions planned for two additional investigational new drug (IND) applications. The Keytruda biosimilar (CT-P51) and Darzalex biosimilar (CT-P44) are in phase 3 trials. The subcutaneous (SC) formulation of Herceptin has completed registration-enabling trials, and the company plans to seek approval in Europe and Korea within three months.
In new drugs, the company has 16 pipelines, including antibody-drug conjugates (ADCs), multispecific antibodies, FcRn inhibitors and obesity treatments. Three ADC candidates and four multispecific antibody candidates entered clinical stages last year, and CT-P70 was designated for Fast Track by the U.S. Food and Drug Administration (FDA).
A Celltrion official said, "We expect to continue high growth this year as structural cost improvements align with the impact of new product launches," adding, "We will push to become a global big pharma based on new growth engines such as biosimilar expansion, new drugs and CMOs."