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Akebia THERAPEUTICS Akebia Therapeutics Reports Third Quarter 2021 Financial Results and Highlights Recent Company Milestones November 4 , 2021 - Pre - commercialization activities underway in anticipation of March 29 , 2022 PDUFA date - Vadadustat marketing authorization application submitted to the European Medicines Agency - Continued growth of Auryxia® ( ferric citrate ) with net product revenue of $ 36.8 million - Company to host Conference Call on Tuesday , November 9 at 9:00 a.m. ET CAMBRIDGE , Mass . , Nov. 4 , 2021 / 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 third quarter ended September 30 , 2021 and highlighted recent corporate milestones . The Company will host a conference call on Tuesday , November 9 , 2021 , at 9:00 a.m. Eastern Time . Executives will highlight publications and scientific presentations of vadadustat Phase 3 clinical data , which will be presented at American Society of Nephrology Kidney Week 2021 beginning today . The Company will also discuss ongoing pre - commercialization activities ahead of a potential first - in - class U.S. launch for vadadustat , Akebia's investigational oral therapeutic for the treatment of anemia due to chronic kidney disease ( CKD ) . Vadadustat is currently under review by the U.S. Food and Drug Administration ( FDA ) with a scheduled Prescription Drug User Fee Act ( PDUFA ) date of March 29 , 2022 . " We are within five months of vadadustat's PDUFA date , which has the potential to be a pivotal catalyst for the company , and , if approved , would mean the availability of a novel , oral therapeutic for people living with anemia due to chronic kidney disease , " said John P. Butler , Chief Executive Officer , Akebia Therapeutics . " We continue to value opportunities to share vadadustat efficacy and safety data with nephrologists through scientific congresses such as ASN Kidney Week . While our review with the FDA is ongoing , we remain confident that the data we have compiled and submitted for review makes a compelling case for approval in dialysis patients . " " Akebia has made substantial progress on pre - commercialization activities to prepare for a first - in - class product launch for vadadustat in the U.S. in 2022 , subject to regulatory approval , " added Dell Faulkingham , Chief Commercial Officer , Akebia Therapeutics . " As part of our commercialization preparation , we are focused on broad access initiatives , and are fortunate that , if approved , our specialized renal sales force will be ready to add a second product for use in the dialysis market . We are working closely with our partners at Vifor and Otsuka to ensure we are well - positioned to execute a successful launch , including preparedness for reimbursement for vadadustat under Transitional Drug Add - on Payment Adjustment ( TDAPA ) for dialysis organizations , which will be key to our launch . " Recent Business Highlights : • Akebia announced that Otsuka submitted a marketing authorization application to the European Medicines Agency for vadadustat for the treatment of anemia due to CKD in adults . • Vadadustat efficacy and safety data is being presented at the American Society of Nephrology Kidney Week 2021 beginning today , November 4 , 2021. Eleven abstracts were accepted for presentation at Kidney Week 2021 . • Akebia has settled all patent litigation proceedings related to Abbreviated New Drug Applications filed with respect to Auryxia® ( ferric citrate ) tablets , which allows for generic versions of Auryxia beginning in March 2025 . • Akebia announced that Ron Frieson , Chief Operating Officer of Children's Healthcare of Atlanta ( CHOA ) , joined Akebia's Board of Directors . Mr. Frieson previously held leadership roles in external affairs , public policy , and diversity at CHOA , the Atlanta Urban League and BellSouth Corporation . Third Quarter Financial Results • Revenues : Total revenue was $ 48.8 million for the third quarter of 2021 compared to $ 60.0 million for the third quarter of 2020. The decrease compared to the same period in 2020 was primarily due to lower collaboration revenue from Otsuka driven by lower development costs incurred subject to cost share provisions under both the Otsuka U.S. Agreement and the Otsuka International Agreement as the Company successfully completed the INNO₂VATE and PRO₂TECT global Phase 3 clinical programs and is currently engaged in close - out activities with respect to the programs . Collaboration revenue will continue to reflect collaboration development activities . o Collaboration revenue was $ 12.0 million for the third quarter of 2021 compared to $ 25.6 million for the third quarter of 2020 . o Net product revenue for Auryxia was $ 36.8 million for the third quarter of 2021 compared to $ 34.4 million for the