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SHOW TIME AT OPKO FORBES
New products and FDA approvals. These are two key factors investors should focus on before putting their trust and money in a biopharma or biotech company, particularly the young ones. And some savvy investors may have spotted such an opportunity with OPKO Health, Inc. (OPK). a diversified drug and medical diagnostics company, with its own significant proprietary drug portfolio.
The reason: One of OPKO’s major drugs, Rayaldee, an oral vitamin D treatment aimed at people suffering from chronic kidney disease, is expected to be approved by the Food and Drug Administration by the end of March.
The expectation for the approval is based on OPKO’s obtaining recently a PDUFA (Prescription Drug User Fee Act) dated March 29, 2016. The PDUFA date represents the deadline for the FDA to approve a new drug. As a result, Wall Street analysts have been effusive in their positive comments about OPKO and its stock. Chronic kidney disease afflicts more than 26 million people in the U.S. alone, according to the National Kidney foundation. Driving the worldwide spread of chronic kidney disease in developed countries are an aging population and the growing problem of obesity.
“The upcoming Rayaldee PDUFA represents the new major catalyst for OPKO,” says Dana Flanders, equity analyst at J.P. Morgan Securities, who rates the stock, currently trading a $11.59 a share, as “overweight.” The analyst notes that OPKO has held labeling discussions with the FDA, and that the company is now researching product pricing, manufacturing preparations and inventory, as well as key hiring of sales representatives for Rayaldee’s launch.
Flanders sees Rayaldee as a “meaningful growth driver” for OPKO and forecasts sales reaching about $500 million by 2025. To demonstrate how big a product Rayaldee could be, that $500 million figure is more than OPKO’s consolidated revenues for all of 2015.
