Akebia Therapeutics, Inc. Q3 FY2024 earnings call

• John Butler discussed progress towards US market availability of Vafseo in Jan 2025, including prescriber demand, contracting with dialysis organizations, and clinical initiatives like the VOICE trial in partnership with US Renal Care.
• Nick Grund detailed commercial supply contracts, with approximately 60% of dialysis patients having access to Vafseo through contracts with DOs and GPOs, and discussed pricing strategy and goals to secure coverage for nearly 100% of dialysis patients.
• Erik Ostrowski provided an overview of third quarter financial results, cash position, and mentioned Akebia's readiness for Vafseo's US launch with an established sales force and inventory in hand.

Total revenue in the third quarter of 2024 was $37.4 million. AURYXIA net product revenue was $35.6 million in Q3 2024 compared to $40.1 million in Q3 2023, primarily due to reduced volume partially offset by price increases and contracting efforts. License collaboration and other revenue was $1.8 million in Q3 2024, steady from $1.9 million in Q3 2023. Cost of goods sold decreased to $14.2 million in Q3 2024 from $18 million in Q3 2023 due to a benefit from selling excess inventory. Research and development expense decreased to $8.5 million in Q3 2024 from $13.3 million in Q3 2023. SG&A expense increased to $26.5 million in Q3 2024 from $22.7 million in Q3 2023 due to prelaunch activities for Vafseo. Net loss was $20 million in Q3 2024 compared to $14.5 million in Q3 2023.

• AURYXIA net product revenue in the fourth quarter of 2024 is expected to be around the level of Q2 2024, lower than Q4 2023, due to supply chain disruption for phosphate binders.
• Akebia has at least two years of cash runway. Post Q3, $9.7 million was raised from an ATM facility, bringing pro forma end of Q3 cash to $43.7 million.
• Expect to generate revenue within the first two years of Vafseo's market availability by targeting the TDAPA eligible patient population and others with enabled access.

• Regulatory uncertainties regarding label expansion to non-dialysis patients, as FDA review and protocol development are uncertain.
• Supply chain disruptions could impact AURYXIA revenue and availability.
• Competition from generics of AURYXIA could affect pricing and market share.

Q: Allison Bratzel asked about Vafseo's label expansion to non-dialysis and feedback from ASN docs.

A: John Butler said they expect to engage with FDA this year on label expansion, and Nick Grund noted increased urgency, specific clinical questions, and recognition of need for alternative therapy from docs.

Q: Ed Arce inquired about dialysis center contract goals and VOICE trial timeline.

A: Nick Grund stated goal is 100% dialysis center coverage, and John Butler discussed VOICE trial as an outcome study to generate data for broader market penetration.

Q: Julian Harrison asked about home dialysis segment contracting and early-stage programs.

A: Nick Grund said home and in-center populations are included in contracts, and John Butler talked about AKB-9090 AKI program on track for clinic entry by end of next year and 10108 retinopathy of prematurity program moving forward.