What: Ahead of its fourth-quarter earnings release on February 29 and a key FDA approval decision slated for March 29, shares in Opko Health (OPK 3.95%) jumped by 17.4% in February.
So What: Opko Health is run by iconic healthcare entrepreneur Phillip Frost, and during the past few years, Frost has been actively acquiring companies to position Opko Health as a leader in both diagnostics and biopharma. In Q4, Opko Health reports that acquiring the specialty lab services company Bio-Reference Labs resulted in revenue soaring 983%, to $276 million, and EPS improving to $0 from a loss last year.
Opko Health's fourth-quarter results also benefited from a $15 million milestone payment tied to the FDA approval of partner Tesaro's (NASDAQ: TSRO) Varubi, a drug for the treatment of chemotherapy-induced nausea. Varubi launched in November, and while fourth-quarter revenue from it was immaterial, Tesaro believes Varubi represents a $1 billion opportunity.
Opko Health also recognized $17.7 million in revenue from Pfizer (PFE -0.23%) last quarter related to Pfizer's licensing of Opko Health's long-lasting human growth hormone in December 2014.
The company's full-year revenue similarly benefited from the inclusion of Bio-Reference Labs sales and Tesaro- and Pfizer-related revenue. Overall, Opko Health reports sales grew 439.7%, to $491.7 million in 2015, and the company's net loss per share improved 85.4%, to $0.06.
Now what: On March 29, the FDA is scheduled to make a decision on Opko Health's wholly owned vitamin D prohormone Rayaldee, which could potentially offer a more-effective way of increasing vitamin D in chronic kidney-disease patients than current solutions. Opko Health estimates that, if approved, Rayaldee will compete in a market it values at $12 billion.
In addition to potential upside from Rayaldee, Opko Health's revenue and earnings could benefit if Bio-Reference Labs' sales team can spark demand for Opko Health's 4Kscore prostate cancer test. The 4Kscore test has yet to make meaningful inroads, but 200 of Bio-Reference Lab's sales people have been trained to sell it, and the company reports that initial results from their efforts are encouraging.
The approval of the chemo-induced nausea and vomiting drug Varubi last fall could also add revenue this year. Tesaro (NASDAQ: TSRO) launched Varubi in November, and while the market for CINV drugs is competitive, Varubi royalties could eventually be meaningful if Tesaro can establish a foothold in the indication.
Additionally, phase 3 top-line data for Opko Health's human growth hormone is anticipated later in the year, and if results are good, then this drug could pay off handsomely. As part of its licensing deal, Pfizer's agreed to $275 million in regulatory milestones, plus royalties or profit-sharing.
Overall, there are a lot of catalysts that could move the needle for Opko Health this year, so it's not surprising that investors are placing bets. Obviously, plenty can go wrong for the company from here, but investors willing to take on some risk might want to buy shares.