A view of Samsung Biologics Plant 4. /Courtesy of the company

Samsung Bioepis Holdings, a newly established bio investment holding company created through the partitioning of Samsung Biologics, has officially launched. With this, Samsung Biologics has shifted to a pure-play contract development and manufacturing organization (CDMO) business model.

Samsung Biologics and Samsung Bioepis Holdings said on the 3rd that their boards of directors each met and approved key matters related to the completion of the spin-off on the 1st. In May, Samsung Biologics announced a spin-off plan and has been proceeding with the process.

◇ Samsung Bioepis Holdings "strengthen the biosimilar business and identify promising new businesses"

Kim Kyung-ah, inaugural CEO of Samsung Bioepis Holdings and CEO of Samsung Bioepis. /Courtesy of Samsung Bioepis Holdings

The officially launched Samsung Bioepis Holdings will have Samsung Bioepis, a biopharmaceutical development and commercialization company focused on the biosimilar (biopharmaceutical copycat drug) business, as a 100% subsidiary, and plans to promote a bio-technology platform development business by establishing a separate subsidiary. The first CEO role will be concurrently held by Kim Kyung-ah, CEO of Samsung Bioepis.

Samsung Bioepis Holdings plans to establish optimal business strategies for each subsidiary and maximize corporate value and shareholder value through active research, development, and investment.

First, it plans to continue strengthening the biosimilar business capabilities it has built up over the past 13 years. It plans to focus on research and development to secure more than 20 competitive products and pipelines (candidate substances) in the biosimilar industry.

For future growth, it will establish a new subsidiary and actively identify promising new businesses based on next-generation technologies. The new subsidiary will discover new growth engines beyond the biosimilar business and drive innovation through a next-generation bio-technology platform development business targeting various modalities (therapeutic approaches).

The new subsidiary will adopt a biotech (Biotech) model as its basic business form, platformizing highly scalable elemental technologies and developing various new drug candidates to pursue joint development with global pharmaceutical companies.

Kim Kyung-ah said, "The launch of Samsung Bioepis Holdings will be an inflection point for a new leap forward to lead the future global bio industry," adding, "We will strengthen synergies across all business sectors and write a unique Epis success story for a better life for humanity."

Since its establishment in 2012, Samsung Bioepis has successfully developed and launched biosimilars for 11 blockbuster biopharmaceuticals, and last year posted its highest performance since its founding, with sales of 1.5377 trillion won and operating profit of 435.4 billion won.

◇ Samsung Biologics "leap to a global top-tier CDMO"

John Rim, CEO of Samsung Biologics, delivers remarks at the Samsung Biologics extraordinary general meeting of shareholders at Songdo Convensia in Yeonsu-gu, Incheon, on Oct. 17. /Courtesy of Samsung Biologics

Samsung Biologics said that with this partitioning, it has been reborn as a pure CDMO and has laid the groundwork for a leap to a global top-tier CDMO.

According to the company, before the partitioning, some client companies that entrusted biopharmaceutical CDMO work raised concerns about the structure in which Samsung Bioepis, which runs the biosimilar business, was a subsidiary of Samsung Biologics, and in some cases this acted as an obstacle to winning orders. The company said that this partitioning overcomes such conflicts of interest concerns and also resolves investors' dilemma of having to invest in two different businesses—CDMO and biosimilars—at the same time.

Samsung Biologics plans to accelerate strengthening its CDMO capabilities based on a three-pillar growth strategy of "manufacturing capacity, portfolio, and global footholds."

By 2032, it plans to complete the second Bio Campus (Plants 5–8) to achieve a super-gap manufacturing capacity of 1,324,000 liters, and to continue diversifying modalities such as antibody-drug conjugates (ADCs) and organoids. Having already secured 17 of the global top 20 big pharma as clients, it will also focus on expanding to the global top 40 clients by targeting markets in Asia, including Japan.

Samsung Biologics CEO John Rim said, "With this partitioning, we have solidified our identity as a pure CDMO and created an opportunity to leap to a global top-tier bio company," adding, "We will continue to strengthen the company's business expertise based on world-class competitiveness to further enhance corporate value."

Meanwhile, ISS (Institutional Shareholder Services), the world's largest proxy advisory firm, recommended voting in favor, recognizing the strategic rationale for strengthening business expertise. The National Pension Service (NPS), the third-largest shareholder (7.3%), also exercised its voting rights in favor.

Once the company partition registration is completed, all procedures for the spin-off will be finalized. To facilitate the partitioning, trading of Samsung Biologics shares, which is temporarily suspended through the 21st, will be partitioned into Samsung Biologics and Samsung Bioepis Holdings shares on the 24th and will be relisted and listed with changes, respectively.

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