Business
Akebia Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Business Highlights
Akebia to host conference call on March 9 at 8:30 a.m. ET Receives positive CHMP opinion for Vafseo™ (vadadustat); anticipates potential Marketing
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"Akebia to host conference call on March 9 at 8:30 a.m. ET \nReceives positive CHMP opinion for Vafseo™ (vadadustat); anticipates potential Marketing Authorization in Europe in May 2023Reports Auryxia® (ferric citrate) net product revenue of $177.1M for 2022, an increase of approximately 24.5% over 2021Sets 2023 Auryxia net product revenue guidance at $175-$180MCAMBRIDGE, Mass., March 9, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the fourth quarter and full-year ended December 31, 2022 and provided business highlights.\n\n \n \n \n \n \n \n\n \n\"We ended our year delivering on our strategic focus, which included a commitment to maximize Auryxia revenue, support vadadustat globally and thoughtfully invest in our pipeline,\" said John P. Butler, Chief Executive Officer of Akebia. \"We believe the work our team executed through the fourth quarter and more broadly in 2022 has put us in a strong position as we prepare for several meaningful upcoming milestones. Building on our positive CHMP opinion for vadadustat in Europe, we anticipate potential Marketing Authorization of Vafseo by the European Commission in May 2023, and we are active in our process to select a partner in Europe to deliver Vafseo to patients with chronic kidney disease (CKD) on dialysis, if approved.\"\nLast month, Akebia announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the European Commission (EC) to approve Vafseo™ (vadadustat), for the treatment of symptomatic anaemia associated with CKD in adults on chronic maintenance dialysis. If approved, an EC Marketing Authorization of Vafseo would be applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. Akebia is seeking a partner to commercialize vadadustat in Europe.\nAdditionally, Akebia had an important year with several key milestones in 2022 and into early 2023:\nAchieved Auryxia revenue of $177.1 million representing 24.5% growth versus 2021;Implemented multiple initiatives to reduce costs and create a clear path to positive cash flows from operations supported by Auryxia revenues;Restructured and simplified the Auryxia...