[Edaily Reporter KIM SAE-MI ] Samsung Bioepis posted improved first-half results, driven by the expansion of direct sales in Europe and its entry into the U.S. and Japanese markets.
#SAMSUNG EPIS HOLDINGS announced on the 24th that Samsung Bioepis posted first-half revenue of 847.1 billion won and operating profit of 230.6 billion won, representing year-over-year increases of 5.7% and 5.9%, respectively.
For the second quarter of this year, revenue stood at 392.2 billion won, a 2.2% decrease from the 401.0 billion won recorded in the same period last year. Operating profit also fell by 3.6% to 86.6 billion won, down from 89.8 billion won in the same period last year.
SAMSUNG EPIS HOLDINGS explained that changes in the supply schedule for key products and expanded research and development (R&D) investments impacted second-quarter performance. The company projected that increased product demand in major markets such as Europe and the U.S. would be reflected sequentially in second-half results.
Expanding Biosimilar Supply… Accelerating New Drug DevelopmentSamsung Bioepis expanded its lineup of products sold directly in Europe to five with the launch of its Eylea biosimilar in May of this year. In the U.S., it began full-scale sales of its Prolia biosimilar, and in Japan, it launched its first product, a Stelara biosimilar.
Development of its follow-on pipeline is also underway. Last month, Samsung Bioepis announced the results of global Phase 1 and Phase 3 clinical trials for “SB27,” a biosimilar candidate for Keytruda. According to the company, the Phase 1 pharmacokinetic (PK) study and the Phase 3 efficacy evaluation confirmed equivalence with the originator drug.
A Samsung Bioepis official emphasized, “Amid intensifying competition in the development of Keytruda biosimilars, Samsung Bioepis is the first to announce the results of a global Phase 3 clinical trial.”
As for new drug candidates, the antibody-drug conjugate (ADC) “SBE303” entered a global Phase 1 clinical trial in March for patients with solid tumors. The second ADC candidate, “SBE313,” is in the preclinical stage. In addition, the company is accelerating new drug development in various fields, including the development of a long-acting obesity treatment.
SAMSUNG EPIS HOLDINGS Maintains 10% Annual Revenue Growth Forecast for This YearSAMSUNG EPIS HOLDINGS
,the holding company, announced that it recorded consolidated revenue of 845.8 billion won and operating profit of 149.3 billion won for the first half of
this year. Second-quarter revenue was 391.9 billion won, and operating profit was 58.7 billion won.
SAMSUNG EPIS HOLDINGS is establishing a holding company structure with Samsung Bioepis as its core subsidiary. Last month, it established its first overseas R&D hub in China to expand its new drug R&D capabilities.
The discrepancy between Samsung Bioepis’s business performance and SAMSUNG EPIS HOLDINGS’ consolidated operating profit stems from the inclusion of non-cash accounting adjustments during the consolidation process. As SAMSUNG EPIS HOLDINGS was established last November, it did not provide year-over-year comparative figures in its consolidated disclosure.
Meanwhile, SAMSUNG EPIS HOLDINGS maintained its previous forecast that Samsung Bioepis’s annual revenue this year will increase by more than 10% from last year’s 1.672 trillion won.
