Vafseo, along with our phosphate binder, Auryxia, generated $227 million in net product revenue in 2025, during which time we also progressed multiple post-marketing clinical trials and advanced and enhanced our growing pipeline. 2025 got off to a very fast start before a number of challenges flattened demand in the second half of the year. We addressed those challenges head-on, we believe today we're starting to see the demand growth that we've expected. While we didn't see the growth we expected in the second half of 2025, we built real excitement for Vafseo.

In addition to the launch of Vafseo in 2025, we introduced our rare kidney disease pipeline, which we believe will be an additional and important value driver for the company going forward. AKB-097 is our tissue-targeted complement inhibitor that we acquired late last year. Like John, I am encouraged by the growth potential for Vafseo in 2026, which is supported by early Q1 data. That said, Vafseo demand in Q4 was slightly down versus Q3, as we reported $6.2 million in Vafseo net product revenue on about $11 million in demand.

We also see the number of prescribers within DaVita starting to increase, with some physicians trialing Vafseo in their patients. We are excited for a strong 2026 and executing on our plans to grow Vafseo revenues and advance our pipeline, including our mid-stage rare kidney disease programs. These increases were driven by sales of Vafseo and an increase in Auryxia sales. The decrease in net loss in both periods was driven by the increase in net product revenues, which was partially offset by higher expenses.

What went well
  • Full-year 2025 net product revenue grew nearly 50% over 2024 to $227 million (Vafseo + Auryxia), driven by the Vafseo U.S. launch and higher Auryxia sales
  • Vafseo launch reached scale: 290,000 patients with prescribing access, over 1,000 prescribers across 24 dialysis organizations one year into launch
  • First-refill adherence improved sharply under observed in-center dosing, rising from ~75% on daily dosing to ~91% in Q4 and ~87% among the larger January cohort
  • Net loss narrowed materially, to $12.2 million in Q4 (from $22.8 million) and $5.3 million for the year (from $69.4 million)
  • Cash position strengthened to $184.8 million at year-end, up from $51.9 million, funding the operating plan for at least two years
  • Growing clinical evidence base: ASN post-hoc composite showed lower death/hospitalization risk vs ESA, and a cost analysis showed ~15% lower Medicare hospitalization costs (~$3,700 savings per patient per year)
What went wrong
  • Vafseo demand flattened in the second half of 2025 after a fast start, with demand roughly flat at ~$12M/$12M/$11M across Q2/Q3/Q4
  • Q4 Vafseo net revenue was only $6.2 million, hurt by a one-time ~$4.8 million inventory drawdown as USRC shifted from home shipment to in-center stocking
  • Slower-than-expected uptake: management admitted dialysis providers did not adopt around the TDAPA economic opportunity as quickly as anticipated
  • Adherence problems earlier in the launch (GI tolerability discontinuations, non-observed daily dosing) held back demand
  • Auryxia revenues are expected to decline in 2026 as generic competition expands beyond the current authorized generic

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Earnings Call Themes & Trends

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Q&A Summary

How should we think about sequential Vafseo growth in 2026 relative to inventory-adjusted Q4 demand, and could VOICE data accelerate uptake? How operationalized is Vafseo access at DaVita?
Management is not guiding on revenue. Setting aside inventory swings, demand has been roughly flat (~$12M Q2, ~$12M Q3, ~$11M Q4) and they now expect and are seeing growth off that base, but steady rather than a hockey stick, similar to the measured nephrology adoption seen in the historical Renagel launch. Published, peer-reviewed data (ASN outcomes, the cost analysis, later VOICE and VOCAL) is what will drive utilization once medical affairs can use it. DaVita has made the product widely available across its network and is starting with its >30,000-patient home dialysis population, leaving prescribing decisions to physicians, so Akebia's field teams must educate and sell.
How are second and third refill rates trending, and what about anemia manager education?
First refill improved from ~75% historically to ~91% in Q4's small observed-dosing subset and ~87% in the larger January cohort. That high adherence is continuing into the second prescription, against an underlying ~2-4% monthly discontinuation from comorbidities and transplants. Moving patients from daily to observed in-center dosing is driving restarts of previously non-compliant patients. On education, Akebia expanded its medical affairs / MSL group to deliver the clinical data to physicians and anemia managers, and dialysis organizations (including DaVita's centralized anemia management model) are actively participating.
How is AKB-9090 mechanistically differentiated from prior HIF inhibitors like vadadustat?
AKB-9090 has different pharmacokinetics and structure. Vadadustat preferentially targets the liver where erythropoietin is made, while 9090 has more widespread tissue penetration into the lung and kidney. In non-clinical ischemia-reperfusion injury models 9090 was clearly the best compound, an indication where vadadustat likely would not work; it comes down to structure and PK.
What does success look like for the VOCAL study, and how important is the red blood cell sub-study?
VOCAL is a 350-patient study DaVita wanted to run in its own units to operationalize and confirm Vafseo is as safe and effective as the ESAs (Mircera) they use today. The primary endpoint is non-inferiority for hemoglobin control; management suspects superiority on some hemoglobin-related safety endpoints (less rapid rises, fewer high hemoglobins, fewer dose adjustments) though those are pre-specified, not primary. The RBC sub-study is expected to be important in showing Vafseo's cells are different (bigger, more hemoglobin, more uniform width distribution), giving physicians a mechanistic reason to believe the death/hospitalization benefits.
Have you reactivated the IND for AKB-097, and did you change the protocol from what Q32 Bio had aligned with FDA?
The IND has not been reactivated yet. The protocol is fundamentally the same one FDA agreed to with Q32 Bio, but it is being reworked to be simpler and less operationally complex to ease recruitment; the company will resubmit the near-final protocol before activating the IND.
How should investors frame expectations for the April 2 R&D Day and what level of detail will you provide?
The agenda is still being finalized, but the focus will be on praliciguat and AKB-097, with external KOLs (not just Akebia employees) speaking to the excitement around the next-generation complement inhibitor, plus depth on the preclinical data underlying the FSGS decision. Akebia will also introduce AKB-9090, its first internally discovered product entering the clinic. The goal is to let investors, who have rightly focused on the Vafseo launch, understand the newly introduced rare kidney pipeline and the expanding HIF capabilities.

More on Akebia Therapeutics, Inc.

Reported 2026-02-26 · figures from the Akebia Therapeutics, Inc. Q4 2025 earnings call.

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