Celltrion

Celltrion develops and manufactures antibody biosimilars and sells them directly in global markets, with development and commercialization inside a single entity following the end-2023 merger with Celltrion Healthcare.

Its portfolio spans the infliximab franchise (Remsima and Remsima SC, marketed as Zymfentra in the United States), oncology biosimilars (Truxima, Herzuma, Vegzelma) and newer immunology and bone-disease products (Yuflyma, Steqeyma, Avtozma, Stoboclo-Osenvelt, Omlyclo).

Eleven products have been commercialized in the United States and Europe, and the company said high-margin new products reached 65% of second-quarter 2026 sales.

Among legacy products, it noted that Truxima took the top share position in the United States on expanded long-term supply contracts, while Remsima kept a leading position in major markets.

In Europe, Remsima SC held roughly 32% share across the five largest European markets in the first quarter of 2026 and 49% in Germany according to IQVIA data, and Vegzelma has kept the number-one share in key countries despite being a late entrant.

The United States hinges on direct sales: the company says it expanded its local headcount from about 50 in 2023 to roughly 100 this year to cover regions and negotiate with large pharmacy benefit managers and has secured reimbursement coverage above 90% of the insurance market.

Alongside this sit non-biosimilar revenue streams, including contract manufacturing supply following the acquisition of Eli Lilly's Branchburg plant in New Jersey and the CDMO business run by Celltrion Biosolutions, established in 2023.

Competition takes the form of multi-product tenders and price rivalry with domestic and global biosimilar makers such as Samsung Bioepis, while originator defense strategies and national tender terms drive share.

On pipeline, the company is targeting a 41-product portfolio by 2038, developing candidates referencing Ocrevus (CT-P53), Cosentyx (CT-P55), Taltz (CT-P52), Keytruda (CT-P51) and Darzalex (CT-P44).

On confirmed figures, 2025 revenue was KRW 4.1625tn, operating profit KRW 1.1685tn and net profit attributable to owners KRW 1.0296tn, for an operating margin of 28.1%.

In 2024 revenue was KRW 3.5573tn with operating profit of KRW 492.0bn and a 13.8% margin, so the striking feature of 2025 is that operating profit more than doubled on a 17% revenue increase.

Management attributes this to the clearing of most post-merger one-off costs, the depletion of high-cost inventory, the end of development-cost amortization and improved production yields, which it describes as structural rather than one-off.

Given margins of 28.3% in 2022 (revenue KRW 2.2840tn, operating profit KRW 647.2bn) and 29.9% in 2023 (revenue KRW 2.1764tn, operating profit KRW 651.5bn), the 13.8% of 2024 looks like the exceptional year of concentrated merger accounting, with 2025 returning to prior margin levels.

Quarterly, the trend ran from KRW 961.4bn revenue and KRW 242.4bn operating profit (25.2%) in the second quarter of 2025 to KRW 1.3301tn and KRW 475.1bn (35.7%) in the fourth, then KRW 1.1449tn and KRW 321.8bn (28.1%) in the first quarter of 2026 and KRW 1.3936tn with KRW 451.7bn (32.4%) in the second.

First-half 2026 revenue of KRW 2.5386tn and operating profit of KRW 773.6bn cover roughly half of the company's stated full-year targets of KRW 5.3tn and KRW 1.8tn.

By product, the company disclosed that Remsima SC generated KRW 356.7bn in Europe, Korea and other markets in the first half, up 20.3%, while Zymfentra in the United States reached KRW 99.5bn, up 176.4%.

Below the operating line, net profit attributable to owners exceeded operating profit in the third quarter of 2025 (KRW 331.3bn), the fourth quarter (KRW 528.4bn) and the first quarter of 2026 (KRW 346.1bn), suggesting sizable non-operating items such as currency effects, so net profit carries more volatility than operating profit.

Cash flow from operations fell to KRW 646.0bn in 2025 from KRW 901.8bn in 2024 while the debt-to-equity ratio rose from 19.8% to 28.7%, showing that higher profit did not translate directly into larger cash inflows.

The biosimilar industry is in a phase where sequential originator patent expiries keep expanding substitution demand.

As reported, global sales of Humira, the reference product for Yuflyma, fell from roughly KRW 12.6tn to about KRW 6.4tn over the past year, illustrating how quickly large molecules are converting to biosimilars.

The underlying markets are also growing: Europe's infliximab market grew at a compound annual rate of about 9% from 2019 to 2024, according to IQVIA.

Structurally, first-generation products face years of price cuts and intensifying competition while newer launches retain higher margins; Morgan Stanley argued in a February 2026 report that newer biosimilars have not yet undergone multi-year price erosion and therefore carry much higher margins than older products.

Seasonality is pronounced, with national tender supply and year-end distributor stocking concentrated in the second half.

Policy risk centers on the United States, where patented drugs face tariffs of up to 100% while generics and biosimilars were excluded from the measure and Korean pharmaceutical imports are subject to a 15% rate under the trade agreement.

In competitive positioning, Celltrion combines in-house manufacturing with direct sales, whereas Samsung Biologics and Lotte Biologics emphasize pure contract manufacturing; commentary notes that Celltrion and Lotte Biologics are also aligning around U.S. production bases and end-to-end services, making it decisive who converts tariff and regulatory change into orders first.

Sector share prices have at times moved independently of earnings, with reports noting that the KRX Health Care index topped 5,600 in February 2026 before falling to around 3,800 by early July.

Management has said that second-half results can exceed the first half as national tender supply and share gains by new products accelerate, and that it aims to surpass its initial full-year targets of KRW 5.3tn in revenue and KRW 1.8tn in operating profit.

It cites as drivers the expansion of new products into more countries, U.S. PBM formulary listings, supply against European public tenders, and year-end distributor stocking.

On products, brokerage analysis noted that Omlyclo, holding sole first-mover status in Europe, reached 21% share within three quarters of launch and recorded KRW 116.7bn of sales in the second quarter of 2026, and Sangsangin Investment & Securities said in a July 2026 report that Omlyclo's U.S. launch is scheduled for the fourth quarter of 2026.

For the infliximab franchise, the company plans to build it into a KRW 1tn annual revenue family through wider European prescribing, Zymfentra growth in the United States and new markets in Japan and Latin America, with a Japanese launch of Remsima SC planned for 2027.

On regulatory milestones, it has filed for domestic approval of the Keytruda biosimilar CT-P51 and plans sequential filings in the United States, Europe and Canada, while the Cosentyx biosimilar CT-P55 is in domestic and North American review and Herzuma SC filings are progressing in major countries.

In manufacturing, KRW 1.2265tn is being invested to expand plants 4 and 5 simultaneously at the Songdo campus in phases through 2030, and Branchburg capacity is set to rise from 66,000 liters to 141,000 liters of drug substance. In novel drugs, the company said CT-P70 and CT-P71 received U.S.

FDA fast-track designation and it targets a 20-asset novel drug portfolio by next year. These plans still face approval, tender and utilization checkpoints, so the pace at which they show up in quarterly results is what matters.