Samsung Bio Achieves Record Q1 Performance... Epis Also Soars

by Lee Myeonghwan

Published 26 Apr.2023 10:53(KST)

Samsung Biologics posted its highest-ever first-quarter performance, while Samsung Bioepis also showed strong results. This came as sales increased compared to the same period last year despite intensified competition in the biosimilar market.

Samsung Bioepis headquarters building exterior. [Photo by Samsung Bioepis]

Samsung Biologics announced on the 24th that its consolidated sales for the first quarter of this year were tentatively estimated at 720.9 billion KRW, with an operating profit of 191.7 billion KRW. This represents a 41% increase in sales and a 9% increase in operating profit compared to the same period last year. Furthermore, it marked the highest first-quarter performance since Samsung Biologics was established. Despite a reduction of 83.5 billion KRW in sales and 79 billion KRW in operating profit due to internal transactions and purchase price allocation (PPA) amortization following the acquisition of Samsung Bioepis as a subsidiary last year, the company still posted improved results compared to the previous year.

Looking at the results on a separate basis, Samsung Biologics recorded first-quarter sales of 591 billion KRW, a 16% growth compared to the same period last year, and operating profit of 234.4 billion KRW, a 33% increase. During the same period, Samsung Bioepis achieved sales of 213.4 billion KRW and an operating profit of 36.1 billion KRW, representing increases of 7% and 4%, respectively, compared to the previous year. The company explained that it showed continuous growth based on a diverse portfolio of biosimilar products in various therapeutic areas in global markets such as Europe.

Analysts note that the steady growth of Samsung Bioepis, which was fully acquired as a subsidiary of Samsung Biologics in April last year, is noteworthy. Despite increasing pressure on prices due to intensified competition in the biosimilar market, sales of existing products increased, improving overall performance. Lee Dong-geon, a researcher at SK Securities, evaluated, "Despite the price decline caused by intensified competition, growth continued based on increased sales volume of existing products and the effect of new biosimilar launches."

There are also forecasts that Samsung Bioepis’s performance will continue to grow for the remainder of this year as it prepares to enter the U.S. and European markets with major biosimilars and launch new products in the second half of the year. The company is set to begin U.S. sales in July of "Hadmira," a blockbuster-level biosimilar of the autoimmune treatment "Humira." "Episcle," a biosimilar of the paroxysmal nocturnal hemoglobinuria treatment "Soliris," has received a positive opinion for marketing authorization from the European Medicines Agency (EMA), with a launch expected in the European market in the second half of the year. The biosimilar "SB11" (product name Amelibu) of "Lucentis," used to treat ophthalmic diseases, is also expanding its sales markets to countries such as Germany and Canada.

Clinical trials for new biosimilar launches are also progressing smoothly. On the 25th, Samsung Bioepis announced that its biosimilar SB15 of the macular degeneration treatment "Eylea" demonstrated equivalence in efficacy and safety compared to the original drug in Phase 3 clinical trials. Heo Hye-min, a researcher at Kiwoom Securities, diagnosed, "With stable supply of Hadmira, European sales prescription data, and a portfolio of low- and high-concentration products that can replace Humira, the company holds momentum for listing on major pharmacy benefit managers (PBMs) in the second half of the year."

However, some predict that performance will inevitably slow down until next year when sales of the Humira biosimilar fully materialize. Park Jae-kyung, a researcher at Hana Securities, pointed out, "Milestone payments received in 2022 will be absent this year, leading to expected declines in sales and operating profit. However, with the Humira biosimilar launch scheduled for July, contributions to performance are expected starting next year."