Amarin Corporation plc (NASDAQ:AMRN) revealed on Thursday that the US Food and Drug Administration (FDA) had already agreed to the proposed amendment of the special protocol assessment (SPA) agreement for REDUCE-IT.
The company also released its second quarter earnings report on Thursday.
SPA Amendment
Under the amended SPA agreement, the final details of the interim and final efficacy statistical analyses are already reflected, along with new secondary endpoint elements. The primary endpoint of the study, however, remains the same.
Steven Ketchum, Ph.D., Amarin Chief Scientific Officer (CSO), believes that the clinical trial has been fine-tuned even more with the approved amendment. Consequently, the company remains encouraged that REDUCE-IT will conclude as a success, ideally by 2018.
Q2 Financial Highlights
For the period, the Ireland-based company had a net product revenue of $32.80 million, up by 85% year-over-year from $17.70 million. For the first half of the fiscal year (FY) 2016, Amarin had a net product revenue of $58.10 million, up by nearly 75.50% year-over-year from $33.30 million. The exceptional year-over-year revenue growth is primarily driven by the strong Vascepa sales.
For the first six months of 2016, Amarin has also posted a net licensing revenue of $500,000.
Given the impressive performance so far, Amarin has given an increased guidance for the FY 2016. It now expects a net product revenue of $125 million, up from a previous guidance of $112 million, and a net licensing revenue of $1.10 million.
Cost of Goods Sold for the six-month period came in at $15.80 million, up from last year’s $12 million. On the other hand, Research and Development (R&D) expenses for the first half of the year were seen at $26.30 million, up from the $24.60 million reported during the same period in 2015. Meanwhile, Selling, General, and Administrative (SG&A) expenses for the said period came in at $54.10 million, up from the previous year’s $50.80 million.
Amarin ended the second quarter with cash and cash equivalents of $72.50 million.
