[Click e-Stock] "Green Cross Nears FDA Approval for Immunoglobulin... Target Price Raised"

On November 24, Samsung Securities raised its target price for Green Cross from 130,000 won to 140,000 won.

Green Cross is awaiting a decision from the U.S. Food and Drug Administration (FDA) in January next year regarding approval for its immunoglobulin blood product, AlyGlo (ALYGLO, IVIG-SN 10%). If approved, the company plans to launch the product in the U.S. market in the second half of next year. As of last year, the U.S. immunoglobulin market was valued at $15.3 billion, with CSL Behring's IVIG 10% (intravenous injection) product Privigen and SCIG 20% (subcutaneous injection) product Hizentra holding the number one market share in the IV and SC blood product segments, respectively. Each product recorded annual sales of $2.83 billion and $1.65 billion, respectively, this year. Green Cross aims for AlyGlo to achieve sales of between 250 billion and 300 billion won, targeting a 1.5% market share.

To raise brand awareness for AlyGlo in the U.S., an increase in initial marketing expenses is inevitable. While direct sales-related costs may rise in the short term, the company expects that from 2025, when U.S. sales are in full swing, these efforts will contribute to improved profitability.

Keunhee Seo, a researcher at Samsung Securities, stated, "There are market concerns about the approval of AlyGlo, given that approval for IVIG-SN has been previously rejected three times following the issuance of Complete Response Letters (CRLs). However, now that the plant inspection has been completed, we expect approval to proceed without significant issues."

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