Akebia Therapeutics (NASDAQ: AKBA) reported Q1 EPS of ($0.62), $0.22 worse than the analyst estimate of ($0.40). Revenue for the quarter came in at $72.67 million versus the consensus estimate of $81.02 million.

• Net Product Revenue for Auryxia Increases to $23.1 Million for Q1’FY19, Up 12.1% from Q1’FY18;
• Full Enrollment of Phase 3 INNO2VATE Studies; and
• Additions to Executive Leadership Team to Support Commercial and Clinical Operations.

“The first quarter marked the achievement of another important milestone for Akebia with the announcement of positive top-line results from two Phase 3, active-controlled, pivotal studies evaluating vadadustat in Japanese patients with anemia due to chronic kidney disease (CKD),” stated John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. “We are excited by these results as they increase our level of confidence in the hypoxia inducible factor (HIF) pathway and more specifically, the direction of our clinical program for vadadustat. These results are expected to serve as the basis for a New Drug Application in Japan (JNDA) by our collaboration partner, Mitsubishi Tanabe Pharma Corporation (MTPC), in 2019.”

Butler continued, “We are also pleased to announce the completion of enrollment in our global Phase 3 INNO2VATE studies evaluating vadadustat for the treatment of anemia due to CKD in dialysis-dependent CKD subjects. With the addition of Dell Faulkingham to our executive team, we have strengthened our commercial capabilities and believe we are well positioned to execute on our revenue growth strategies for Auryxia. Lastly, we look forward to welcoming Dr. Steven Burke as our new Chief Medical Officer as we continue to execute on the multiple catalysts expected with vadadustat’s Phase 3 program over the next 12 to 18 months.”

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