Core Insights - Akebia Therapeutics reported strong early results from the U.S. launch of Vafseo, expecting net product revenues of approximately $10-$11 million for Q1 2025 [1][2] - The company anticipates that its cash resources and cash from operations will be sufficient to fund its current operating plan for at least two years [1][12] Vafseo U.S. Commercial Update - Vafseo shipments began on January 9, 2025, with the first prescription written on January 13, 2025 [6] - Three of the top four dialysis organizations in the U.S. have placed orders for Vafseo, and over 500 prescribers have written prescriptions, averaging about 8 prescriptions each [6] - Vafseo has been recommended for symptomatic anemia in adults undergoing dialysis for CKD by the U.K. National Institute for Health and Care Excellence (NICE) [6] Additional Key Business Updates - Akebia plans to initiate a Phase 3 clinical trial (VALOR) for Vafseo in late-stage CKD patients not on dialysis, with expectations to begin in the second half of 2025 [6][12] - The VOICE clinical trial has enrolled more than half of its target of 2,200 patients [6] Financial Results - Total revenues for Q4 2024 were $46.5 million, down from $56.2 million in Q4 2023, and full-year revenues were $160.2 million compared to $194.6 million in 2023 [6][7] - Auryxia net product revenues were $44.4 million in Q4 2024, down from $53.2 million in Q4 2023, and $152.2 million for the full year compared to $170.3 million in 2023 [6][7] - Research and development expenses increased to $11.8 million in Q4 2024 from $9.9 million in Q4 2023, while full-year R&D expenses decreased to $37.7 million from $63.1 million [12][35] Cash Position - Cash and cash equivalents as of December 31, 2024, were approximately $51.9 million, up from $42.9 million as of December 31, 2023 [12][37] - The company raised $18.4 million through share sales and accessed $9.3 million from the BlackRock Credit Agreement post year-end [12]
Akebia Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Vafseo® (vadadustat) Commercial Launch Progress Update