Samsung Bioepis headquarters in Songdo, Incheon /Courtesy of Samsung Bioepis

Samsung Bioepis, a subsidiary of Samsung Bioepis Holdings, is reviewing the acquisition of Organon in the United States, its overseas biosimilar product sales partner.

According to the investment banking industry on Jan. 5, Samsung Bioepis is conducting due diligence for an Organon acquisition. An industry official said, "The first round of due diligence was completed at the end of last year, and the next steps are underway."

Organon was launched in 2021 when Merck (MSD) spun off its women's health products and biosimilar sales businesses, and it is listed on the New York Stock Exchange. Organon's 2024 sales were about $6.43 billion (about 9.3106 trillion won), up 2% from a year earlier, of which biosimilar business sales were $662 million (957.9 billion won).

Organon took over from MSD the sales rights to biosimilar products contracted with Samsung Bioepis and is currently selling five biosimilars — "Renflexis (Remicade)," "Ontruzant (Herceptin)," "Hadlima (Humira)," "Aybintio (Avastin)," and "Benepali (Enbrel)" — in the United States, Canada, Europe, and Australia.

Recently, Organon sold off business divisions one after another. Samsung Bioepis is understood to have reviewed various scenarios with an eye toward acquiring Organon's management control or its biosimilar business unit.

However, the investment banking industry also noted that because it is still at the due diligence stage, it is uncertain whether Samsung Bioepis will make a final acquisition. The company is reviewing other overseas partners as acquisition targets as well as Organon.

Samsung Bioepis has so far sold most of its products through the distribution networks of global partners such as Organon, Biogen, and Sandoz. Of Samsung Bioepis' eight biosimilar products launched in the United States and Europe, Organon handles sales of five and Biogen handles four.

Samsung Bioepis has already begun expanding direct sales, centered on Europe. Starting with "Epysli (Soliris)" in 2023, it has been directly selling two bone disease treatments, "Obodence (Obodence)" and "Xbryk (Xbryk)," in the European market since this month. In addition, it decided to directly sell the ophthalmology biosimilar "Byooviz," which Biogen had been selling in Europe. The company received the return of European commercialization rights from Biogen in October last year, and as a result, the number of directly sold products in Europe increased to four.

A senior Samsung Group official said, "As biosimilar competition has intensified recently, the need to switch to a direct sales system has grown," and explained, "Because revenue recognition is limited under a sales agency structure, the strategy is to seek top-line growth through direct sales."

Regarding this, a Samsung Bioepis official said, "We are not reviewing an Organon acquisition, and that is not true."

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