[Click eStock] "Hanmi Pharm's Licensed New Drug Approved by FDA... Royalty Income Expected Next Year"

[Asia Economy Reporter Ji Yeon-jin] Hanmi Pharmaceutical's newly developed drug for neutropenia, Rolontis (U.S. brand name Rolvedon), recently received new drug approval from the U.S. Food and Drug Administration (FDA), drawing attention to whether its stock price will soar again.

On the 13th, Samsung Securities announced that it raised Hanmi Pharmaceutical's target stock price to 360,000 KRW by reflecting the new drug value of 239 billion KRW, changing the clinical success probability applied to Rolvedon from 80% to 100%. The previous target price was 343,327 KRW.

In 2012, Hanmi Pharmaceutical licensed the global rights of Rolontis, excluding Korea, China, and Japan, to the U.S. pharmaceutical company Spectrum. The FDA granted new drug approval on the 9th, and sales are expected to begin in the fourth quarter of this year. Spectrum, which acquired the rights to this drug, saw its stock price jump 17.4% in pre-market trading on the 12th. Seogeunhee, a researcher at Samsung Securities, said, "Following FDA approval, additional funding is expected due to increased costs by partner Spectrum before reaching expected sales," adding, "Initial sales related to Hanmi Pharmaceutical's production and royalties are expected to be somewhat slow."

According to the U.S. Securities and Exchange Commission (SEC), due to revisions between the two companies this year, the $10 million milestone payment related to approval will be paid as royalties starting from the third year after launch. Yim Yoon-jin, a researcher at Daishin Securities, stated, "Royalties are expected to be paid at a lower level than the existing mid-to-high 10% range for a certain period," adding, "Rolontis' U.S. sales next year are estimated at about $60 million, with a market share of approximately 2%, and Hanmi Pharmaceutical's incoming royalties, excluding production margin, are expected to be about 4 billion KRW."

Heo Hye-min, a researcher at Kiwoom Securities, also predicted that royalties related to Rolontis will be 4.3 billion KRW next year. Researcher Heo said, "Rolontis' sales in 2026 are expected to reach $413 million, with an inflow of about 20 billion KRW," adding, "Since the drug substance (DS) for Rolontis is also supplied, raw material sales are expected to be added as well."

On the same day, Eugene Investment & Securities calculated the expected value of Rolontis at about 230 billion KRW and maintained a buy investment opinion and a target stock price of 360,000 KRW. Kwon Hae-soon, a researcher at Eugene Investment & Securities, said, "The U.S. sales of Rolontis and Poziotinib are judged to be new profit growth engines that can offset the possibility of slowing domestic growth for Hanmi Pharmaceutical in the future," adding, "Assuming a 2023 launch, the combined sales of the two products in the fifth year after launch, 2027, are estimated at about 450 billion KRW, and the profit reflected to Hanmi Pharmaceutical is estimated at about 60 billion KRW based on operating profit, which is about 38% of this year's operating profit."

This content was produced with the assistance of AI translation services.