Akebia Therapeutics, Inc. Q1 FY2025 earnings call

• Vafseo Launch: Delivered US net product revenues of $12M, exceeding guidance. Prescribers and refills are growing. Top dialysis organizations have ordered Vafseo, with a large provider pilot starting in Q3 and another expected to make the product available on an exception basis.
• VOICE Study: ~75% enrolled towards target of 2200 subjects, aims to generate data on Vafseo benefits.
• Auryxia: Strong Q1 results despite IP exclusivity loss in March, but future sales uncertain due to generic competition.
• Pipeline: Working towards multiple product candidates entering clinic in 2025, including VALOR trial in NDD scheduled for second half 2025.

Total revenues increased to $57.3 million in Q1 2025 from $32.6 million in Q1 2024. Net product revenues were $55.8 million in Q1 2025 compared to $31 million in Q1 2024. Vafseo contributed $12 million in net revenues. Auryxia had net product revenues of $43.8 million in Q1 2025, up from $31 million in Q1 2024. Cost of goods sold was lower in Q1 2025 due to no non-cash amortization charge for Auryxia and Vafseo sales from pre-launch inventory.

• Vafseo launch expected to continue growing with large dialysis providers rolling out pilots.
• VALOR trial in NDD remains on track for second half 2025.
• Auryxia sales uncertain due to uncertainty around timing of additional generic competition.

• Generic competition for Auryxia: Uncertainty around when other generics will be approved.
• Dialysis market complexity: Selling in the dialysis market has complexities, though strategy is progressing.
• FDA regulatory changes: Potential impacts on trial initiation and approval timelines for NDD.

Q: Update on Vafseo timelines for large dialysis organizations and impact on metrics A: Large provider pilot starts Q3, with broader rollout in Q4, expected to double patient access Q: Shift from Auryxia to authorized generic A: Minimal impact in Q1, AG entry post-March 20th, but uncertain when other generics approved Q: Net price and NDD trial A: Net price expected to decrease with volume, NDD trial on track despite FDA changes Q: Demand drivers for Vafseo and reimbursement A: Driven by clinical benefits and TDAPA incentives, positive reimbursement trends with Medicare Advantage coverage Q: Inventory and label expansion A: Inventory within normal ranges, label expansion in NDD market with large patient population and high potential