Beijing Hanmi Contributes Significantly to OP Growth
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed.
Hanmi Pharm posted consolidated 1Q22 sales of W321.1bn and OP of W38.7bn, in line with our estimates, thanks to Beijing Hanmi and business normalization amid the easing of the Covid-19 pandemic. Global achievement is needed for key pipelines awaiting FDA approval
Beijing Hanmi and favorable operating environment support estimate-meeting earnings growth
We maintain a Hold rating and TP of W305,000 on Hanmi Pharm. The firm posted consolidated 1Q22 sales of W321.1bn (+18.8% y-y) and OP of W38.7bn (+29.1% y-y), satisfying our estimates. Earnings growth was attributable to Beijing Hanmi’s earnings growth and reduced Covid-19 effects.
Major consolidated subsidiary Beijing Hanmi recorded 1Q22 sales of W94.8bn (+29.1% y-y) and OP of W25.5bn (+32.7% y-y), contributing significantly to overall OP growth. Hanmi Pharm achieved non-consolidated 1Q22 sales of W226.6bn (+15.0% y-y) and OP of W14.7bn (+30.9% y-y), largely thanks to increased sales of respiratory medicines (amid Covid-19) and higher sales of major IMDs upon reviving marketing activities. However, overall sales and OP both decreased in q-q terms due to an absence of royalty income.
Pipeline status updates
Rolontis, a Neutropenia treatment, re-applied for BLA to the FDA in March, and the PDUFA date is scheduled for Sep 9 of this year. Since it is reviewed under a new drug category, the drug price strategy for competing biosimilars and Spectrum’s distribution strategy in the US should determine the value of the drug. The PDUFA date for Pogiotinib, a treatment for HER2-mutated non-small cell lung cancer patients with treatment history, is set for Nov 24.
The phase IIa trial for the dual agonist (a nonalcoholic Steatohepatitis treatment) with MSD is scheduled to wrap up by end-2022, with data to be released before that point. The triple agonist under development for the same indication is in the process of global phase IIb trials. Data for such is to be released after the data release for the dual agonist. In addition, the pan-RAF inhibitor Belbarafenib, which has been transferred to Roche, is undergoing phase I clinical trials for the triple combination of the Roche drugs, Cortelic and Thycentric, targeting NRAS-mutated Melanoma.