Relypsa (RLYP) Tops Q1 EPS by 20c

Relypsa (NASDAQ: RLYP) reported Q1 EPS of ($1.26), $0.20 better than the analyst estimate of ($1.46). Revenue for the quarter came in at $12.4 million versus the consensus estimate of $6.88 million.

“We made great progress in our first full quarter with Veltassa on the market. We saw solid month-over-month growth of prescriptions, reported early success with payers, including agreements with the two largest pharmacy benefit managers, and have had a positive reception from treating physicians,” said John A. Orwin, president and chief executive officer of Relypsa. “Yesterday, we announced a debt financing that will support the ongoing U.S. launch of Veltassa. In addition, with the recent submission of an MAA requesting European approval of Veltassa, we are another step closer to bringing Veltassa to patients outside the United States.”

Quarterly Business Highlights

• 2,498 new patients started taking Veltassa with a free-starter supply. 1,155 outpatient prescriptions were covered by payers and dispensed (retail TRx). 374 hospital/institution units were sold (non-retail).
• The Centers for Medicare and Medicaid Services (CMS) included Veltassa in its Current Year (CY) 2016 Formulary Reference File (FRF) and agreements were signed with Express Scripts and CVS Caremark, the two largest pharmacy benefit managers in the United States.
• Across all payer plans, Veltassa has broad coverage with more than 80 percent of all plans covering to date. Approximately half of the Company’s target national and regional payers have made coverage decisions for Veltassa and, of these, 75 percent have decided to cover Veltassa in a Tier 3 or better position.
• Relypsa announced positive results from Phase 1 drug-drug interaction studies with Veltassa.
• The company initiated a Phase 4 study (TOURMALINE), evaluating Veltassa’s safety and efficacy when given with and without food.

Recent Announcements and Upcoming Milestones

• On April 25, 2016, Relypsa and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) announced a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) requesting European approval of Veltassa for the treatment of hyperkalemia.
• On April 28, 2016, data from new analyses of studies with Veltassa were presented at the National Kidney Foundation 2016 Spring Meeting.
• On May 3, 2016, Relypsa announced the close of a $150.0 million debt financing.
• By mid-2016, the company plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting a label change for Veltassa based on the results of the drug-drug interaction studies.

For earnings history and earnings-related data on Relypsa (RLYP) click here.

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