Akebia to host conference call at 8:00 a.m. ET on May 9 Vafseo® (vadadustat) tablets FDA approved on March 27, 2024 Vafseo launch activities underway with availability expected in January 2025 Auryxia® (ferric citrate) net product revenues were $31.0 million for the first quarter 2024, Akebia expects 2024 Auryxia net product revenue growth versus 2023  CAMBRIDGE, Mass., May 9, 2024 /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 first quarter ended March 31, 2024. Akebia is launching Vafseo® (vadadustat) tablets, recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months, which will be available in January 2025. "The recent FDA approval of Vafseo represents a transformational milestone for Akebia as we initiate launch activities that we believe will enable widespread access and rapid adoption when Vafseo is available in January 2025," said John P. Butler, Chief Executive Officer of Akebia. "Upon FDA approval of Vafseo, we initiated work to drive demand from potential prescribers and to contract with dialysis providers. We are progressing plans for generating clinical data to identify additional areas of potential benefit to patients as we remain committed to the kidney community. We also expect to engage with the FDA on label expansion opportunities for Vafseo by the end of this year." Recent Business Highlights Akebia plans to submit its application for Transitional Drug Add-on Payment Adjustment (TDAPA) for Vafseo in June. Akebia expects the application to be accepted in July 2024 and expects TDAPA designation in January 2025. In March, Akebia presented posters at the 2024 Annual Dialysis Conference on the cardiovascular safety of vadadustat in patients new to dialysis with CKD-related anemia and the safety and efficacy of vadadustat in the treatment of anemia in U.S. patients with CKD. In April, Akebia's licensee Averoa, a biopharmaceutical company, submitted a marketing authorization application to the European Medicines Agency for Ferric Citrate Coordination Complex, and, if approved, Averoa will make the product available to patients in Europe. In April, Akebia drew down the second tranche of its $55.0 million BlackRock debt facility and received net proceeds of $7.5 million. Ten million dollars of borrowing capacity remains available under the debt facility until December 31, 2024, subject to the conditions in the loan agreement. In May, Akebia signed an amendment to its License Agreement with Vifor International Ltd. (Vifor) to modify the method of repayment of its working capital fund through tiered royalties based upon Akebia's sales of Vafseo, significantly simplifying the repayment terms. Akebia reported first quarter 2024 Auryxia® (ferric citrate) net product revenues of $31.0 million. Akebia reaffirms that it expects Auryxia net product revenue growth in 2024 versus 2023. The Centers for Medicare and Medicaid Services released guidance on incorporating phosphate binders, including Auryxia, into the dialysis bundle in January 2025. Akebia is accelerating contracting discussions with dialysis organizations with a goal to ensure broad access to Auryxia. "With continued revenue contributions from Auryxia, revenue from Vafseo beginning in 2025, and our current cash balance, we believe we have sufficient cash to support operations for at least the next two years while investing in the Vafseo launch," Mr. Butler added. Financial Results Revenues: Total revenues were $32.6 million for the first quarter of 2024 compared to $40.0 million for the first quarter of 2023. Net product revenues were $31.0 million for the first quarter of 2024 compared to $34.7 million for the first quarter of 2023. License, collaboration and other revenues were $1.6 million for the first quarter of 2024 compared to $5.3 million for the first quarter of 2023. COGS: Cost of goods sold was $11.6 million for the first quarter of 2024 compared to $20.2 million for the first quarter of 2023. Akebia continues to carry a non-cash intangible amortization charge of $9.0 million per quarter through the fourth quarter of 2024. R&D Expenses: Research and development expenses were $9.7 million for the first quarter of 2024 compared to $19.7 million for the first quarter of 2023. SG&A Expenses: Selling, general and administrative expenses were $25.4 million for the first quarter of 2024 compared to $25.1 million for the first quarter of 2023. Net Income / Loss: Net loss was $18.0 million for the first quarter of 2024 compared to a net loss of $26.9 million for the first quarter of 2023. Cash Position: Cash and cash equivalents as of March 31, 2024, were approximately $42.0 million. Akebia expects its existing cash resources and cash from operations will be sufficient to fund its current operating plan, including a U.S. Vafseo launch, for at least the next two years. Conference Call Akebia will host a conference call on Thursday, May 9 at 8:00 a.m. Eastern Time to discuss first quarter 2024 earnings. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time. A live webcast of the conference call will be available via the "Investors" section of Akebia's website at: https://ir.akebia.com/. An online archive of the webcast can be accessed via the Investors section of Akebia's website at https://ir.akebia.com approximately two hours after the event. About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release. About Vafseo® (vadadustat) tablets Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries. INDICATIONVAFSEO is indicated for the treatment of anemia due to chronic kidney ...