NASH Pipeline Data Disclosure Slated for 2H22
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed.
Hanmi Pharm posted consolidated 2Q22 sales of W316.5bn and OP of W29.6bn, with OP coming in slightly below our estimate. Beijing Hanmi led consolidated OP growth, booking OP of W17.1bn. The strength of Hanmi Pharm’s new drug development capabilities should be confirmed again with an upcoming data release in 2H22.
Beijing Hanmi and favorable business environment lead earnings growth
We maintain a Hold rating and TP of W305,000 on Hanmi Pharm. The firm disclosed consolidated 2Q22 sales of W316.5bn (+13.3% y-y) and OP of W29.6bn (+86.4% y-y), with OP coming in 10% below our estimate but beating consensus by 24%. Consolidated OP growth was mainly led by Beijing Hanmi.
The Chinese subsidiary posted sales of W78.5bn (+31.8% y-y) and OP of W17.1bn (+98.6% y-y), accounting for 58% of consolidated OP. Hanmi Pharm reported non-consolidated sales of W237.3bn (+6.6% y-y) and OP of W13.5bn (+31.5% y-y). No licensing fee income was recorded.
NASH pipeline data disclosure slated for 2H22 to determine future value
Phase IIa trials with MSD for a dual agonist treatment for nonalcoholic steatohepatitis are due to be completed by yearend, with data set to be released before that time. A triple agonist under development for the same indication is in the process of global phase IIb trials. Dual agonist data is scheduled to be released in 2H22, and investors can expect quick clinical trial progress and the receipt of milestones income. Triple agonist data will be released at a later date. In addition, the pan-RAF inhibitor belvarafenib, which has been licensed out to Roche, is undergoing phase I trials for a triple combination with Roche drugs, cortellic and Tecentriq, targeting NRAS-mutated melanoma.
Pipelines at Spectrum (Hanmi’s US partner) should receive the green light in 2H22, and afterwards, their marketability is set to be verified. Spectrum re-submitted a BLA to the FDA for neutropenia treatment Rolontis in Mar 2022, and the PDUFA date is set for Sep 9. The FDA is currently assessing the firm’s manufacturing facility. Assuming that Rolontis is approved as a new drug candidate, Spectrum will need to establish a drug price strategy to compete with already-launched biosimilars. We believe that Spectrum’s US distribution strategy will determine the value of the drug. Meanwhile, the PDUFA date for Poziotinib, an HER2-mutated non-small cell lung cancer treatment, is set for Nov 24.