Akebia Therapeutics(AKBA) - 2024 Q3 - Quarterly Results

Product Development and Market Launch - Vafseo® (vadadustat) is on track for U.S. market availability expected in January 2025[1] - Vafseo received TDAPA reimbursement approval, effective January 1, 2025, along with a Level II Healthcare Common Procedure Coding System code[4] - Akebia has partnered with U.S. Renal Care to initiate a trial evaluating mortality and hospitalization outcomes for dialysis patients taking Vafseo[2] - Akebia expects to enter into contracts with additional dialysis providers to increase coverage for Vafseo throughout 2024[25] - The company plans to establish Vafseo as the new oral standard of care for dialysis patients with anemia[25] Financial Performance - Total revenues for Q3 2024 were $37.4 million, down from $42.0 million in Q3 2023, with Auryxia® net product revenues at $35.6 million compared to $40.1 million[7] - Total revenues for Q3 2024 were $37,428,000, a decrease of 11.5% from $42,046,000 in Q3 2023[28] - Product revenue, net for Q3 2024 was $35,592,000, down from $40,118,000 in Q3 2023, reflecting a decline of 11.8%[28] - Net loss for Q3 2024 was $20.0 million, compared to $14.5 million in Q3 2023, including $4.4 million in non-cash interest expense[12] - Net loss for Q3 2024 was $20,039,000, compared to a net loss of $14,489,000 in Q3 2023, representing an increase in loss of 38.5%[28] Expenses and Cost Management - Cost of goods sold (COGS) decreased to $14.2 million in Q3 2024 from $18.0 million in Q3 2023, aided by a $3.7 million benefit from selling previously written-down inventory[9] - Research and development expenses were $8.5 million in Q3 2024, down from $13.3 million in Q3 2023, due to completed clinical trials and reduced costs[10] - Research and development expenses for Q3 2024 were $8,487,000, a decrease of 36.5% from $13,330,000 in Q3 2023[28] - Selling, general, and administrative expenses increased to $26.5 million in Q3 2024 from $22.7 million in Q3 2023, driven by preparatory activities for Vafseo[11] - Selling, general and administrative expenses increased to $26,516,000 in Q3 2024, up from $22,710,000 in Q3 2023, marking an increase of 16.4%[28] Cash Position - Cash and cash equivalents as of September 30, 2024, were approximately $34.0 million, expected to fund operations for at least two years[13] - Cash and cash equivalents as of September 30, 2024, were $34,019,000, down from $42,925,000 as of December 31, 2023[29] - Akebia's existing cash resources are expected to fund its current operating plan, including the U.S. Vafseo launch, for at least two years[25]