Akebia Therapeutics, Inc. Q2 FY2025 earnings call

• Vafseo Launch: Generated over $13M in Q2 revenue, 55% increase from Q1. U.S. Renal Care was the majority revenue source. Broader access expected with DCI, IRC, and DaVita. VOICE trial fully enrolled, VOCAL study initiated.
• Nondialysis Indication: Working to secure approval for nondialysis patients, completed Type B meeting with FDA, planning Type C meeting, aim to initiate VALOR trial by year-end.
• Financials: Q2 2025 total revenues $62.5M, up from $43.6M in Q2 2024. Net product revenues $60.5M, up from $41.2M. Cost of goods sold decreased due to no noncash amortization charge for Auryxia.

Vafseo: Generated over $13 million in revenue in Q2 2025, with ~$12 million in demand sales, a 55% increase from Q1. Auryxia: Sales increased to $47.2 million in Q2 2025 from $41.2 million in Q2 2024. Total revenues for Q2 2025 were $62.5 million, with net product revenues at $60.5 million, up from $41.2 million in Q2 2024.

• Vafseo Growth: Expect to increase prescribing access from ~40,000 to over 75,000 in Q3, and to over 275,000 in Q4 with DaVita on board.
• Nondialysis Trial: Plan to initiate VALOR trial by year-end.
• Auryxia: Auryxia sales resilient but future competition uncertain, budget conservatively.

• Generic Competition: Uncertainty around timing and impact of additional generic competition for Auryxia.
• Clinical Trial Risks: Risks associated with clinical trial enrollments, protocol adherence, and regulatory approvals for nondialysis indication.

Q: Patient segment and payer details A: Patient segmentation includes home use and high ESA patients. Medicare Advantage coverage is growing, with 20% of prescriptions in MA vs. 80% in fee-for-service.

Q: Average dose strength for Vafseo A: Refill scripts show a 28% increase over the 300-milligram starting dose, with potential to titrate up to higher doses as patients progress.

Q: DaVita pilot and nondialysis trial timeline A: DaVita pilot expected to conclude in ~3 months, leading to over 275,000 patients in Q4. Nondialysis trial initiation depends on enrollment feasibility, aiming for year-end start.

Q: Auryxia competitive dynamics A: Auryxia sales resilient but future generic competition uncertain; budget conservatively due to potential timing of additional generics.