Akebia Therapeutics, Inc. Q1 FY2026 earnings call

Product Launch - Vafsio

• Revenues were nearly $16 million in Q1, highest quarter of VastioNet product revenue to date.
• Growth driven by dialysis organizations implementing observed dosing protocol.
• Approximately 1,025 prescribers wrote prescriptions for Vafsio in Q1, 28% higher than Q4 2025.
• 60% increase in patients on Vafsio from end of Q4 2025 to end of Q1 2026 to nearly 7,500 patients.

Clinical Evidence Building - Vafsio

• Post hoc hierarchical composite endpoint analysis from phase three Innovate program published in Journal of the American Society of Nephrology, showing lower risk of dying or being hospitalized for patients treated with Vafsio.
• Economic analysis showed patients treated with Vafsio had 7.7% fewer hospitalization events annually, 16% reduction in hospitalization days, and 14.8% lower annual hospitalization cost.
• VOCAL study at DaVita clinics and VOICE trial by U.S. Renal Care ongoing, with top-line data expected in early 2027.

R&D Pipeline

• Prolisiglot Phase II study ongoing for focal segmental glomerular sclerosis, targeting up to 60 patients on maximally tolerated background dose of ACEs or ARBs, primary endpoint UPCR change at 24 weeks.
• AKB097 (Ebrebifus or Ebre) Phase II open-label basket trial expected in second half of 2026 for IgA nephropathy, lupus nephritis, and C3 glomerulopathy.
• Initiation of phase one study of AKB9090, HIF-PH inhibitor, for prevention of acute kidney injury associated with cardiac surgery.

In Q1 2026, Vafsio revenues were nearly $16 million, representing the highest quarter of VastioNet product revenue to date. Vafsio net product revenues were $15.8 million in Q1 2026 compared to $12 million in Q1 2025, a 32% increase. Arixia net product revenues were $36.2 million in Q1 2026 compared to $43.8 million in Q1 2025, driven by lower prices due to increased generic competition. License collaboration and other revenues were $1.6 million in Q1 2026 compared to $1.5 million in Q1 2025.

Vafsio

• Expect continued growth in Vafsio revenue as adoption broadens and more data is generated.

Arixia

• Expect Arixia revenues to decrease in 2026 compared to 2025 due to increased generic competition.

Pipeline

• Expect top-line data from AKB9090 phase one study in early 2027, and initial data from AKB097 basket study in 2027.

Market Competition

• Increased generic competition for Arixia could further impact revenues.

Clinical Trial Risks

• Risks associated with clinical trials for pipeline products, including challenges in enrolling patients and achieving study endpoints.

Regulatory Risks

• Uncertainties in regulatory approval processes for pipeline products which could delay or impact their commercialization.

Q: Could you talk more about the prominent increase of patients on Vafsio in March, did you see follow through of that trend into April and was there a specific dialysis provider accounting for most of that uptake? And second, is SILSPARI's recent approval relevant to enrollment efforts in FSGS?

A: Nick responded that the increase in patients was across major dialysis organizations, USRC, IRC, DCI had increases with USRC moving to observed dosing protocol, DaVita had growth but lagged. Steve commented that SILSPARI's approval is not expected to have significant impact on FSGS trial enrollment as it's not a game-changer for most patients.

Q: Regarding the first refill adherence at 86%, how should we think about that level as we move dosing scales more broadly across DOs? And regarding VAPCO growth in 2026, should we expect linear growth or more back half weighted?

A: Nick said 86% adherence level is likely to hold as observed dosing protocol broadens. On VAPCO growth, Nick stated it's hard to predict linear or back half weighted growth but sees significant room to grow with DaVita expected to move to observed dosing protocol.

Q: For Prolisiglot development in FSGS, what do you view as the most clinically relevant change for the 24-week UPCR primary endpoint?

A: Steve responded that they would like to see around a 20% improvement in the change in UPCR on par with sparsentin, and the key metric will be the proportion of patients who end up with a UPCR less than 0.7 grams per gram which is the approvable endpoint for FSGS.