Five new products post 335% sales surge to 388 billion won in Q3

Omriclo captures 30% European market share; US supply deals secured with major healthcare firms

Second-half seasonal demand and direct-sales leverage seen driving further gains

Celltrion's Global Biotechnology Research Center. [Celltrion]
Celltrion's Global Biotechnology Research Center. [Celltrion]

Celltrion, which set an all-time quarterly earnings record in the third quarter, is expected to sustain its growth momentum into the fourth quarter.

Analysts say a sharp rise in the sales mix of high-margin new biosimilar products is driving qualitative growth, and that the combined effect of European tender wins, early positioning in US supply chains, and the seasonal second-half upturn in the biopharmaceutical industry will push results even higher.

Record earnings led by high-margin new products; profitability improvement gains pace

Celltrion posted consolidated third-quarter sales of 1.58 trillion won ($1.18 billion), up 53.1 percent year-on-year, while operating profit rose 74.3 percent to 525.3 billion won. The operating profit margin reached 33.3 percent, up 4.0 percentage points from a year earlier, beating market consensus for the third consecutive quarter.

The expansion in both scale and profitability was driven by high-margin new products. New products' share of total biopharmaceutical sales widened 13 percentage points to 67 percent in the third quarter, from 54 percent in the same period last year. Sales of five new biosimilars launched sequentially since last year jumped 335 percent year-on-year to 388 billion won in the quarter.

Securities analysts have taken note of the improved product mix. "Profit margins improved both year-on-year and quarter-on-quarter, thanks to the better product composition driven by sales growth of the five new products launched last year and the fixed-cost leverage effect," said Heo Hye-min, an analyst at Kiwoom Securities.

European tender wins and US market entry accelerate

Celltrion is also accelerating its foothold in Europe and the United States, its two largest global markets. The standout performer in Europe is Omriclo (omalizumab), a treatment for allergic diseases. Launched in Europe as a first mover in September last year, the product captured a 30 percent market share — based on IQVIA data — in roughly one year.

Omriclo generated 132.1 billion won in sales in the third quarter alone, with cumulative sales through the first three quarters reaching 320.5 billion won, a 542.3 percent jump year-on-year. "In a market free of rival products, Omriclo has been rapidly gaining share on the strength of differentiators that improve convenience for hospital staff — including a longer shelf life and extended room-temperature storage compared with the originator," said Kim Hyeon-seok, an analyst at Hyundai Motor Securities.

Stovoklor/Osenvelt (denosumab), a treatment for bone diseases, and Aptozma (tocilizumab), a treatment for autoimmune diseases, also benefited from European tender wins, posting third-quarter sales of 112.2 billion won and 81.1 billion won, respectively — up 461 percent and 1,743.2 percent year-on-year.

In the United States, the world's largest pharmaceutical market, Celltrion has moved to diversify its supply channels. Omriclo and Aptozma secured exclusive supply agreements with a major US healthcare company in early October, establishing access to a hospital network. An additional supply deal for Omriclo with a large retail distributor further extended the company's reach across both insured and uninsured markets.

"Following Omriclo's US launch in October, the company secured a supply contract with a major healthcare firm and a preferred formulary listing with a pharmacy benefit manager, with initial order volumes exceeding expectations," said Hong Ga-hye, an analyst at Daishin Securities. "Stovoklor/Osenvelt and Aptozma are also expected to broaden their US sales base and contribute to growth."

Seasonal tailwinds and high-margin product growth fuel Q4 record expectations

The biopharmaceutical industry's characteristic pattern of weaker first-half and stronger second-half performance also supports optimism for the fourth quarter. Tender supply volumes awarded in Europe during the second and third quarters are typically delivered in concentrated batches in the second half of the year, while healthcare institutions and distributors tend to build up inventory toward year-end ahead of the following year.

Profitability metrics are also expected to benefit from structural leverage as the direct-sales network matures. "The rate of increase in selling and administrative expenses is falling relative to the growth in new products, which will amplify the operating leverage of the direct-sales network," said Kim Jun-young, an analyst at Meritz Securities. "The portfolio strength that allows successive new products to be added to the existing global direct-sales network is the key to medium- and long-term growth."

A Celltrion official said European tender wins and US pharmacy benefit manager listings are the twin pillars driving earnings growth, with actual supply and sales from those deals concentrated in the second half, ensuring that the third quarter's momentum carries into the fourth. "We will continue to invest in research and development for new drugs and next-generation products to secure future growth engines, while doing everything we can to sustain record-breaking earnings through year-end," the official said.


silverpaper@heraldcorp.com