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Akebia THERAPEUTICS Akebia Reports First Quarter 2021 Financial Results and Highlights Recent Company Milestones May 10 , 2021 - Vadadustat New Drug Application ( NDA ) submitted to the U.S. Food and Drug Administration ( FDA ) - Results of global Phase 3 programs for vadadustat published in New England Journal of Medicine - Conference call today at 9:00 a.m. ET CAMBRIDGE , Mass . , May 10 , 2021 / PRNewswire / -- Akebia Therapeutics® . Inc. ( Nasdaq : AKBA ) , a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease , today reported financial results for the first quarter ended March 31 , 2021 and highlighted recent corporate milestones . The Company will host a conference call today , Monday , May 10 , 2021 , at 9:00 a.m. Eastern Time . " Akebia is off to a great start in 2021 , building positive momentum with solid execution on strategic priorities that set the stage for an exciting year . Most importantly , we submitted the vadadustat NDA to the FDA , a significant milestone for Akebia and our partner , Otsuka Pharmaceutical Co. Ltd. We are also very proud that the New England Journal of Medicine recently published the results from both INNO₂VATE and PRO₂TECT , the global Phase 3 programs for vadadustat . We believe these publications reinforce the scientific rigor and quality of the vadadustat clinical development program , and we are pleased with early feedback from the medical community , " stated John P. Butler , Chief Executive Officer of Akebia . " We believe this progress positions us well to continue advancing vadadustat with the goal of bringing this novel therapeutic to patients as quickly as possible , subject to regulatory approval . We remain confident in the clarity and quality of our data , and we look forward to engaging with the FDA on our NDA . In addition , we are working with Otsuka on the preparation of a Marketing Authorization Application ( MAA ) for vadadustat for submission to the European Medicines Agency ( EMA ) , expected this year . " Recent Business Highlights : • In April , the New England Journal of Medicine ( NEJM ) published the results of Akebia's global Phase 3 program for vadadustat , which consisted of two programs that evaluated the efficacy and safety of vadadustat versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis ( INNO₂VATE ) and not on dialysis ( PRO₂TECT ) . • In March , Akebia submitted an NDA to the FDA for vadadustat for the treatment of anemia due to CKD in both adult patients on dialysis and adult patients not on dialysis . • In February , Akebia completed a non - dilutive transaction with an entity managed by HealthCare Royalty Management , LLC ( HCR ) , to monetize the Company's rights to receive royalties and sales milestones on vadadustat net sales under its collaboration agreement with Mitsubishi Tanabe Pharma Corporation ( MTPC ) , with an upfront payment of $ 45 million . • In February , Akebia announced that LeAnne M. Zumwalt joined Akebia's Board of Directors . Ms. Zumwalt recently served as Group Vice President , Government Affairs at DaVita Inc. • In February , Akebia launched its Medical Engagement Hub , an online resource dedicated to scientific education and connecting U.S. healthcare professionals with Akebia Medical Affairs . • In January , the University of Texas Health Science Center at Houston ( UTHealth ) in Houston , Texas , announced that it had received $ 5.1 million in government funding for its study evaluating the use of vadadustat as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome ( ARDS ) , a complication of COVID - 19 . This investigator sponsored research study is currently underway and actively enrolling patients . First Quarter Financial Results • Revenues : Total revenue was $ 52.3 million for the first quarter of 2021 compared to $ 88.5 million for the first quarter of 2020. The decrease compared to the same period in 2020 was primarily due to lower collaboration revenue consistent with the Company successfully completing the INNO₂VATE and PRO₂TECT global Phase 3 clinical programs . o Collaboration revenue was $ 21.9 million for the first quarter of 2021 compared to $ 59.3 million for the first quarter of 2020 . o Net product revenue was $ 30.4 million for the first quarter of 2021 compared with $ 29.2 million for the first quarter of 2020 , an increase of 4 percent . • COGS : Cost of goods sold was $ 34.6 million for the first quarter of 2021 compared to $ 27.7 million for the first quarter of 2020. The increase was driven by higher non - cash purchase accounting adjustments as a result of the merger with Keryx , and a $ 5.1 million non - cash charge to inventory reserves related to a previously disclosed manufacturing quality issue related to Auryxia® ( ferric citrate ) , partially offset by an $ 8.9 million non - cash gain due to a reduction to the liability for