String Of Positives For Lupin Lifts Outlook
Regulatory clearances for some key sites awaited
Executive Summary
Tentative FDA approval for Lupin’s arformoterol tartrate inhalation solution and a potential EC nod for etanercept are seen aiding the company’s prospects in FY2021. Besides, success in a Phase III trial for secnidazole to treat trichomoniasis bodes well, though manufacturing clearances and continuity will also be closely watched.
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Despite Imminent Etanercept Launch, Lupin Cuts FY21 Forecast
Despite plans to launch a biosimilar to Enbrel in August and a generic to ProAir in September, Lupin cut its FY21 EBITDA forecast to 17% from 19-20%, as first-quarter revenues were hit by COVID-19 and a recall of metformin in the US. Meanwhile, it sees the US “Buy American” order for some essential medicines as a near-term opportunity
COVID-19 Demand Gives Lupin Optimism On Albuterol
Lupin hopes a surge in demand for albuterol sulphate due to increased off-label use in COVID-19 patients will help its generic version, which is likely to be launched in the first half of FY21. But the Indian firm may recall a batch of metformin after the US FDA recently asked a few companies to retract extended-release versions due to NDMA concerns.