The South Korean CDMO began work on the site in Incheon in November 2020, with the multi-story 238,000 square-meter building set to be the world’s largest biopharmaceutical manufacturing facility of its kind with 256,000 liters total manufacturing capacity.
Large scale manufacturing contracts secured
This morning Samsung Biologics announced record-high semi-annual revenue, exceeding KRW 1 trillion ($821m).
The company’s CDMO business recorded revenue of KRW 503.7bn, while the Samsung Bioepis biosimilars business recorded KRW 232.8bn.
Samsung Bioepis has 6 biosimilar products approved and commercially available in different markets, and notes that revenue has steadily grown driven by increases in global product sales and milestone payments.
SB4, a biosimilar to Enbrel (etanercept), which was launched in Europe in 2016, has surpassed its originator’s sales in Europe.
The company recently launched SB11, a biosimilar to Lucentis (ranibizumab), in June 2022 in the US.
"With four biosimilar candidates in late stage development, Samsung Bioepis is solidifying its position as a leading company in the biosimilars industry," says Samsung Biologics.
Reporting under the consolidated approach for the first time since the acquisition in April, Samsung Biologics and Samsung Bioepis in the second fiscal quarter recorded a revenue of KRW 651.4bn, operating profit of KRW 169.7bn, and net profit of KRW 152bn with EBITDA margin of 39.7%.
On a standalone basis, the second quarter 2022 revenue for Samsung Biologics was KRW 503.7bn, an increase of 22.2% from KRW 412.2bn reported for the second quarter in the previous year, due to efficiency in operations despite a scheduled slow-down of Plant 2, and attributable to the expansion of product sales.
Samsung Biologics also reported an operating profit of KRW 171.9bn, 3.18% higher than the prior-year period, and a net profit of KRW 101.8bn with an operating profit margin of 34.1% for the same quarter.
On a standalone basis, Samsung Bioepis earned KRW 232.8bn in revenue, 24.2% higher than the prior-year period attributable to the increase in sales of its biosimilar products in global markets including the US and Europe.
Samsung Bioepis’s operating profit increased significantly by 95.7% compared to the prior-year period, at KRW 58.5 bn.
Commenting on the fiscal year 2022 outlook, the CDMO said: “The construction of Samsung Biologics Plant 4 is on schedule with 6 X 10KL production capacity expected to commence operations in October.
“The company has secured a number of large scale manufacturing contracts with active presales activities for Plant 4, and at the close of Q2, in the first half of 2022 alone, the company had secured over $7.9bn in sales backlog including deals with Janssen, Merck, GSK, Lilly, and Novartis to name a few.”
Plant 4 is set to cater for clients from large-scale commercial manufacturing to small-scale CMO, with a flexible facility featuring a line-up of bioreactors ranging from 2,000-liters, 10,000-liters, and 15,000-liters.
The Super Plant will also provide a full range of CDO, CMO, and CRO processes to offer a complete one-stop service, including early-stage development capabilities and large-scale commercial manufacturing with integrated aseptic fill/finish capabilities and a full QC Lab for testing services.
Earlier this month, Samsung Biologics announced it had secured additional land sized at 357,366 ㎡ and approximately 30% larger than its current site, to support the build out of its second campus. The site will host additional large-scale manufacturing facilities as well as an open innovation facility.
Samsung Biologics also published its second annual ESG Report this month, reporting progress in reducing scope 1 and 2 emissions.