Celltrion enjoys record earnings on healthy biosimilar biz

South Korean pharmaceutical giant Celltrion Inc. logged record quarterly earnings on the strong performance of its key biosimilar products while expecting its merger with sales affiliates to help the group meet long-term targets.

Celltrion Inc. said on Tuesday its operating profit soared 25.2% to 267.6 billion won ($204.8 million) in the third quarter from a year earlier with sales up 4.1% to 672.3 billion won. Profit and revenue came in at all-time quarterly highs, beating estimates of 220 billion won and 620 billion won, respectively, compiled by financial data tracker FnGuide Inc.

“We are securing future growth engines as key products including next-generation items such as Yuflyma and Remsima SC are entering new markets and expanding their global shares,” said a Celltrion Inc. official in a statement, referring to its autoimmune disease treatments.

STRONG FOOTHOLDS

Its core biosimilars including Remsima, Truxima and Herzuma held their firm footholds, the company said. Remsima SC, the world’s first subcutaneous injection (SC) formulation of biosimilar infliximab, accounted for 36% and 25% of the German and French markets, respectively, in the second quarter, Celltrion Inc. quoted the global life science industry research firm IQVIA as saying. Truxima, a treatment for rheumatoid arthritis made up 22.3% of the European market during the period, while Herzuma, a drug for early stage breast cancer, accounted for 21.7%.

The US Food and Drug Administration last month approved Remsima SC, or the brand name Zymfentra, which will be launched during the first quarter of 2024 in the country.

“The drug is the only SC-type infliximab treatment,” said another Celltrion Inc. official. “Once we secure a patent, it will not have any competitors until 2040.”

The drug is expected to help patients significantly cut costs by administrating it at home without going to a medical center, the official said.

“We will be able to maximize profit as we can command a high price for it as a novel drug,” said the official, adding the company expected the treatment to generate sales of 3 trillion won by 2030.

Celltrion Inc. is scheduled to introduce new biosimilars with an aim to secure 11 product portfolios by 2025.

Authorities in the US and Europe are reviewing its biosimilar of Stelara, a monoclonal antibody medication developed by Janssen Pharmaceuticals, for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The FDA is also assessing Celltrion Inc.’s biosimilar referencing Eylea, a medication for wet macular degeneration and metastatic colorectal cancer. The South Korean biosimilar behemoth is preparing an application to submit to European authorities for approval of the drug.

The company sought approval for a biosimilar of Xolair, a drug for asthma, nasal polyps, and urticaria, from Europe while preparing an application submission for the medicine to the US.

Celltrion Inc.’s biosimilar for Actemra, a drug for rheumatoid arthritis, systemic juvenile idiopathic arthritis, a severe form of arthritis in children, and COVID-19, is in phase 3 clinical trials.

The company aims to develop new drugs based on various technologies such as microbiome.

TO MERGE WITH AFFILIATES

Celltrion group moved one step closer to the planned combination of its three major affiliates with shareholders of Celltrion Inc. and Celltrion Healthcare Co. overwhelmingly approving the merger of the two.

The combined entity is scheduled to launch on Dec. 28. Celltrion group aims to integrate its domestic distribution affiliate Celltrion Pharm Inc. with the merged unit in six months.

“We aim to expand market dominance by strengthening transparency through simplifying trading structures and improving cost of sales,“ said the other Celltrion Inc. official. “The (planned) integrated Celltrion is likely to step forward to a sales goal of 12 trillion won by 2030 once we conclude the merger within this year.”

Last year, the group logged 2.3 trillion won in revenue.

Celltrion Healthcare separately said its operating profit fell 30.3% to 505 billion won in the third quarter from a year earlier on higher costs although sales jumped 30.5% to a record 647.6 billion won.

Write to Jeong Min Nam at peux@hankyung.com
 
Jongwoo Cheon edited this article.