Biotech's Week Ahead: Relypsa, GW Pharmaceuticals, Regeneron And Exelixis

It’s an exciting week ahead for pharmaceutical companies Relypsa Inc (NASDAQ:RLYP), GW Pharmaceuticals PLC-ADR (NASDAQ:GWPH), Regeneron Pharmaceuticals Inc (NASDAQ:REGN), and Exelixis, Inc. (NASDAQ:EXEL), as analysts are anticipating these companies’ quarterly reports and sales updates on key drugs. Here is what to watch as each company posts earnings this week:

Relypsa Inc

The pharmaceutical company is expected to report first quarter earnings Wednesday, May 4 after market close. Analysts expect the company to post a loss per share of ($1.46) for the quarter and ($5.57) for the upcoming fiscal year. In the same quarter of last year, the company posted a loss per share of ($0.78).

Relypsa projects total operating expenses in the range of $275 to $300 million for 2016, claiming that the expenses will primarily be driven by ongoing commercialization and further clinical studies of Veltassa. Veltassa, Relypsa’s primary drug, is a potassium binder approved for the treatment of hyperkalemia. Demand for the drug has been increasing since it became available on December 21, 2015. From its release date, to February 12, 2016, there have been 1,229 new outpatient prescriptions for Veltassa.

2015 was a big year for Relypsa with the launch of its promising drug, but what is in store for 2016? The pharmaceutical company plans to submit a sNDA by mid-2016 to the FDA requesting a label change for Veltassa due to a recent successful Phase 1 drug-drug interaction study. Also, Relypsa is initiating a new Phase 4 clinical study of Veltassa, aimed at evaluating the drug’s safety and efficacy when given with and without food. If results for this are positive, it will only promote more success for the stock and positive reviews. Analysts will be listening for an update on this progress, as well as overall Veltassa sales.

Further, Relypsa and VFMCRP, which became a partner in 2015, are on track to submit a Marketing Authorization Application (MAA) for Veltassa to the European Medicines Agency (EMA).

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